Needling device and drug applicator

Abstract

To provide a device which makes it easy to provide a programmable massage and drug administration operation and to replace and refill liquid or drug to be administered.SOLUTION: A needling device may be used for needling of a subject's skin. A drug applicator device may be used for applying a drug to a subject's skin. For example, a needling device may be applied to a subject's skin for hair growth application, or may be used for wrinkle, scar, or tattoo removal. A drug applicator device may be used for multiple drug application purposes such as applying a hair growth compound to the skin of a subject.SELECTED DRAWING: Figure 2

Description

[Technical field]

[0001] 1. CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Patent Application No. 62 / 233,373, filed September 27, 2015. , the entirety of which is incorporated herein by reference for all purposes.

[0002] 2. BACKGROUND OF THEINVENTION 2.1 Field of the Invention The following description refers to the insertion of a needle into the skin of a subject by a user, e.g., a physician or any user. and a needle insertion device for performing massage and applying fluid or medication to the skin of a subject. In one embodiment, the present invention relates to a fluid or drug delivery applicator device for administering a fluid or drug to a subject. Elephants are subjects in need of hair growth or induction of hair follicle neogenesis, and those who need to prevent hair loss. and / or subjects described in Section 5.5. The implantation device may be applied to the skin of a subject for hair growth applications, or may be used for wrinkle removal, scar removal, It may also be used for hair removal, tattoo removal, and pigmentation. The present invention is directed to a variety of drug application purposes, such as for applying hair growth compounds to the skin of a subject or for other purposes. The compositions may be used for the treatment of a variety of dermatological conditions. [Background technology]

[0003] (2.2 Description of Related Art) The needle insertion device typically does not penetrate deeper areas of the subject's skin or scalp. It is used for tattoo removal or wrinkle removal mechanisms by lightly piercing the subject's skin. In the conventional needle insertion device, the user cannot easily replace the needle insertion adapter. The sterility of the combination device cannot be maintained. Conventional devices also require the physician to Furthermore, conventional needle insertion devices must be sterilized by the user or clinic. It provides a needle set that does not allow for uniform needle penetration and interchangeability and versatility of the device. In the conventional needle insertion array, the user or operator performs the needle insertion operation while The area is provided in such a way that it cannot be clearly seen.

[0004] Such as the applicator described in U.S. Patent Application Publication No. 2008 / 0161737 to Hilditch Examples of conventional drug applicators include those that allow for manual administration of drugs and are used for massage therapy. However, such devices are not programmable and cannot be programmed by the user or Physicians cannot program the device to automatically follow pre-set procedures. There is no provision for simple replacement or refilling of medications that are not available and should be administered. grammable massage and drug administration operations, and replacement of liquids or drugs to be administered What is needed is a device that provides this ease of replacement and replenishment. Summary of the Invention

[0005] (3. Overview) In one embodiment, the needle insertion device comprises a sheath assembly having a needle array, and a main unit having a motor for driving the sheath, The main unit is constructed so that it is completely enclosed within the main assembly, and all parts of the main unit are externally In a specific embodiment, the needle array is protected from the environment. The needle insertion device is driven by the motor in a direction parallel to the longitudinal axis of the needle insertion device. In one embodiment, the needle insertion device is a device for inserting needles into a human scalp to promote hair growth. to perform needling of skin tissue for skin repair or needling of scar tissue for scar removal. In a specific embodiment, the needle insertion device is adapted for treating baldness or chemotherapy-induced In a specific embodiment, the needle insertion device is adapted to treat alopecia areata. The device is adapted to disrupt the basal or suprabasal epidermal layer of human skin. In one embodiment, the sheath assembly completely covers the main unit. As a result, the host unit remains substantially germ-free, sterile, or free of biological contamination. In one embodiment, the needle insertion device further comprises a biological barrier within the sheath assembly. In a specific embodiment, the sheath assembly is In a specific embodiment, the sleeve further comprises a sleeve cap. The recording unit is removable for inserting or removing the recording unit. wherein the sheath cap is adapted to cover the fully enclosed main unit from the interior of the sheath assembly. The needle array is configured to control the depth of the needle array without removing the needle. In an embodiment, the depth of the needle array is determined by the depth of the sheath assembly toward the skin of a subject. from a depth extending beyond the end of the sheath assembly to a depth extending completely within the sheath assembly away from the skin of the subject. In a specific embodiment, the main unit is The sheath cap further includes a knit cap, and the sheath cap rotates the main unit cap. In a specific embodiment, the needle insertion device is configured to The needle insertion device can be controlled without removing the fully enclosed main unit from within the pouch. The sheath assembly further comprises one or more buttons located on a surface thereof for controlling the In one embodiment, the one or more buttons are adapted to control the depth of skin penetration of the needle array, One or more of a needle insertion speed, a power source for the needle insertion device, and an LED for illuminating the disturbed area are selected. In a specific embodiment, the main unit is configured to control the needle. Further comprising a main unit cap and a drive shuttle chassis for controlling the depth of the array. The sheath assembly further includes a sheath cap, and the user can rotate the sheath cap. In response to the rotation of the main unit cap, the drive shuttle chassis is rotated. , the needle array is axially shifted and the depth of the penetration of the needle array is adjusted. In embodiments, the needle insertion device eliminates needle drag on the subject's skin. In one embodiment, the needle array has a rectangular base and two substantially rectangular needles on the rectangular base. The needles are arranged in parallel rows, resulting in increased needle penetration speed and reduced number of needle penetration strokes. In a specific embodiment, the main unit includes a pre-insertion unit for controlling needle insertion. The method further comprises: providing a drive shaft configured to contact the needle array. In the present invention, the main unit further comprises a driving element, and the driving element drives the needle array. a drive shaft for actively controlling the forward and return motion of said The positive motion is toward the skin of the subject, and the return motion is away from the skin of the subject. In a specific embodiment, the needle insertion device The needle insertion device is designed to eliminate vibrations when operating the device, reducing fatigue on the user's hands. In a specific embodiment, the main unit is configured to: and a drive element attached to the motor for controlling the corrective and return motion. The motion is toward the skin of the subject, and the return motion is away from the skin of the subject. and directed to said needle insertion device. and a means for emitting infrared rays, the needle array and the means for emitting infrared rays to stimulate hair follicles on the scalp of the subject. In a specific embodiment, the stimulation can be performed using both infrared radiation and the The needle insertion device further comprises a light source for illuminating a target area on the subject's skin.

[0006] In another aspect, the needle insertion device includes a sheath assembly having a needle array and a controlled a main unit having a motor for driving the needle array in a needle-insertion manner, The array comprises a rectangular base and two substantially parallel rows of needles on the rectangular base, As a result, the needle insertion speed is increased and the number of needle insertion strokes is reduced.

[0007] In yet another aspect, the needle insertion device includes a sheath assembly having a needle array, and a main unit having a motor for driving the array, wherein the main unit comprises: A main unit cap and a drive shuttle shaft for controlling the penetration depth of the needle array. The sheath assembly further comprises a sheath cap, and the sheath assembly further comprises a sheath cap, and the user In response to rotating the cap, the main unit cap is rotated and the drive shuttle The needle array is then moved axially to change the depth of penetration of the needle array in the skin. will be adjusted.

[0008] In an additional embodiment, the needle insertion device includes a sheath assembly having a needle array, and a main unit having a motor for driving the needle, a drive shaft configured to contact the needle array to control insertion; and the driving element actively controls the positive and negative motions of the needle array. and the positive motion is toward the skin of the subject. and the return motion is away from the skin of the subject and towards the needle insertion device.

[0009] In another additional embodiment, the method of using a needle insertion device to stimulate hair growth comprises the steps of: a sheath assembly having a needle array and a main unit having a motor for driving the needle array; and opening the sheath assembly to completely insert the main unit into the needle. The main unit is disposed inside the sheath assembly so as to be enclosed and protected from the external environment. In a specific embodiment, the method includes: wherein the sheath assembly includes a needle array, and the method includes removing the sheath assembly. and replacing the sheath assembly with another sheath assembly having a different needle array. It further includes:

[0010] In yet another additional embodiment, a needle insertion device and a drug application device are provided to stimulate hair growth. The method of using the actuator includes a sheath assembly having a needle array and a actuator for actuating the needle array. The present invention provides a needle insertion device having a main unit having a motor for inserting the needle into the housing. A drug delivery cartridge held by a housing and a device for massaging the skin of a subject. and a massage head mounted on the housing for drug delivery and massage. and a drug applicator for breaking down layers of the human scalp using said needle insertion device. and performing targeted skin disruption to destroy the skin. After using the needle insertion device, administering a drug to the human scalp. using the drug applicator to apply the drug to the damaged area. In one embodiment, the disrupted layer of the human scalp is the basal layer of the epidermis or the suprabasal layer of the epidermis. and the applied drug is minoxidil, lactacystin, peptidyl a proteasome inhibitors such as aldehydes or pentoxyfilline (PTX) In a specific embodiment, the method includes delivering the drug directly to the human scalp. In a specific embodiment, the method further comprises: massage the drug delivered to the human scalp to spread the drug evenly. Further includes:

[0011] In a further embodiment, the applicator for drug delivery and massage comprises a housing. a drug delivery cartridge, and a massage head mounted on the housing. wherein the drug delivery cartridge is coupled to a dispenser that is coupled to the movement of the massage head. In a specific embodiment, the device is configured to automatically administer the drug by a mechanism comprising: The applicator stretches or massages the subject's skin while simultaneously administering the drug. In a specific embodiment, the amount of drug being administered is , number of massage strokes per massage cycle, by controlling the stroke distance or profile of the dosing mechanism. In a specific embodiment, the applied drug is minoxidil or lac Proteases such as tachystin, peptidyl aldehyde, or pentoxifylline (PTX) In a specific embodiment, the drug delivery cartridge and the macula tumefacilitator are The massage head is installed and simultaneously removed and replaced by the user. In a specific embodiment, the massage head is configured to be rigid. In a specific embodiment, the massager comprises a flexible disk and a resilient massage element. The speed of the movement of the massage head and the vibration frequency of the massage action part are controlled by the user. In a specific embodiment, the adjustable vibration of the massaging portion is The frequencies include 1 Hertz, 2 Hertz, and 4 Hertz. The actuator detects the rotation angle of the massage head and uses the detected angle to determine the projection. The device further comprises a controller and a sensor configured to determine the administered dose. In one embodiment, the applicator is in a massage only mode or a massage In a specific embodiment, the massage head is operable in a dispensing mode. The rotation angle determines whether the applicator is in the massage only mode or the massage mode. In a specific embodiment, the application The applicator further includes a keypad disposed on a surface of the applicator. In an embodiment, the applicator includes an LED and a controller for determining when it is time for the next dose. The LED may further include a control unit configured to operate the LED in response to a In an embodiment, the applicator includes a housing for charging the applicator. The device further comprises an inductive charging base configured to receive the charging ring. In the method, the applicator includes a light source for irradiating a target area of ​​the user's skin. The device further comprises a source.

[0012] In a further embodiment, the applicator for drug delivery and massage comprises a housing. a drug delivery cartridge for administering a drug, the drug delivery cartridge being held by the housing; a massage head mounted on the housing for massaging the elephant's skin; The drug delivery cartridge is mounted within a housing and adapted to provide a massaging effect. A cam drive unit for rotating the massage head and the massage head, and a cam drive unit for rotating the massage head and configured to detect an angle of rotation and use the detected angle to determine an administered dose. In a specific embodiment, the drug delivery cartridge comprises a controller and a sensor. The device and massage head are attached and detached simultaneously by the user. In a specific embodiment, the massage head is configured to be replaceable. The massage head comprises a rigid disk and a resilient massage element. The rotation speed of the massage head and the vibration frequency of the massage action part are controlled by the user. In a specific embodiment, the adjustment of the massaging portion is adjustable by a Possible frequencies include 1 Hertz, 2 Hertz, and 4 Hertz. The applicator can be operated in a massage only mode or a massage and dispense mode. In a specific embodiment, the rotation angle of the massage head is Whether the caterer is performing the massage only operation or the massage and administration operation In a specific embodiment, the applicator controls whether the applicator The application further comprises a keypad disposed on the surface. The controller is configured to operate the LED in response to determining that it is time for the next dose. In a specific embodiment, the application further comprises a control unit configured to: a charger configured to receive the housing for charging the applicator; The device further includes an inductive charging base.

[0013] In a further embodiment, the method of using the applicator for hair growth applications comprises: a drug delivery cartridge carried by the housing; and a drug delivery device mounted on the housing. providing an applicator having a massage head attached thereto, said applicator and administering a drug to the massage head via a dispensing mechanism coupled to the movement of the massage head. In a specific embodiment, the applied drug is Noxidil, or lactacystin, peptidyl aldehyde, or pentoxifylline In a specific embodiment, the application is a proteasome inhibitor, such as protease inhibitor (PTX). The method of using the applicator further includes remotely controlling the applicator. In a specific embodiment, the method of using the applicator comprises the step of: A user interface is used to receive notifications from the applicator and In a specific embodiment, the remote user further comprises interacting with the - The interface communicates with the user to facilitate compliance with set parameters. A mobile application configured to trust [Brief description of the drawings]

[0014] (4. Brief description of some of the views of the drawings) The foregoing summary, as well as the following detailed description, will be better understood when read in conjunction with the appended drawings. For purposes of illustration, certain embodiments of the present disclosure have been shown in the drawings. It should be understood that the invention is not limited to the precise arrangements and instrumentalities shown. The accompanying drawings, which are incorporated in and constitute a part of this document, illustrate systems and devices in accordance with the present invention. It illustrates the implementation and, together with the description, serves to explain the advantages and principles according to the invention. .

[0015] [Figure 1] FIG. 1 is a right perspective view showing an example of a needle insertion device.

[0016] [Diagram 2] FIG. 2 is a left perspective view showing an example of a needle insertion device.

[0017] [Diagram 3] FIG. 3 is a right side elevational view of an example needle insertion device.

[0018] [Figure 4] FIG. 4 is a left side elevational view showing an example of a needle insertion device.

[0019] [Diagram 5] FIG. 5 is a top elevational view of an example needle insertion device.

[0020] [Figure 6] FIG. 6 is a bottom elevational view of an example needle insertion device.

[0021] [Figure 7] FIG. 7 is a top end elevational view of an example needle insertion device.

[0022] [Figure 8] FIG. 8 is a bottom end elevational view of an example needle insertion device.

[0023] [Figure 9] FIG. 9 is a right perspective view showing an example of a needle insertion device including a needle insertion adapter.

[0024] [Figure 10] FIG. 10 is a left perspective view showing an example of a needle insertion device equipped with a needle insertion adapter.

[0025] [Figure 11] FIG. 11 is a right side elevational view showing an example of a needle insertion device including a needle insertion adapter.

[0026] [Figure 12] FIG. 12 is a left elevational view showing an example of a needle insertion device equipped with a needle insertion adapter.

[0027] [Figure 13] FIG. 13 is a top elevational view showing an example of a needle insertion device including a needle insertion adapter.

[0028] [Figure 14] FIG. 14 is a bottom elevational view of an example needle insertion device including a needle insertion adapter.

[0029] [Figure 15] FIG. 15 is a top end elevational view of an example needle insertion device including a needle insertion adapter.

[0030] [Figure 16] FIG. 16 is a bottom end elevational view of an example needle insertion device including a needle insertion adapter.

[0031] [Figure 17] FIG. 17 is a right perspective view showing an example of a needle insertion adaptor for a needle insertion device.

[0032] [Figure 18] FIG. 18 is a left perspective view showing an example of a needle insertion adapter for a needle insertion device.

[0033] [Figure 19] FIG. 19 is a right side elevational view showing an example of a needle insertion adapter for a needle insertion device.

[0034] [Figure 20] FIG. 20 is a left elevational view showing an example of a needle insertion adapter for a needle insertion device.

[0035] [Figure 21] FIG. 21 is a top elevational view showing an example of a needle insertion adapter for a needle insertion device.

[0036] [Figure 22] FIG. 22 is a bottom elevational view of an example needle insertion adapter for a needle insertion device.

[0037] [Figure 23] FIG. 23 is a top end elevational view showing an example of a needle insertion adapter for a needle insertion device.

[0038] [Figure 24] FIG. 24 is a bottom end elevational view of an example needle insertion adapter for a needle insertion device.

[0039] [Diagram 25] FIG. 25 is a right perspective view showing an example of a needle insertion device with a charging station.

[0040] [Figure 26] FIG. 26 is a left perspective view showing an example of a needle insertion device equipped with a charging station.

[0041] [Figure 27] FIG. 27 is a right side elevational view of an example needle insertion device with a charging station.

[0042] [Figure 28] FIG. 28 is a left side elevational view of an example needle insertion device with a charging station.

[0043] [Figure 29] FIG. 29 is a top elevational view of an example needle insertion device with a charging station.

[0044] [Diagram 30] FIG. 30 is a bottom elevational view of an example needle insertion device with a charging station.

[0045] [Diagram 31] FIG. 31 is a top end elevational view of an example needle insertion device with a charging station.

[0046] [Diagram 32] FIG. 32 is a bottom end elevational view of an example needle insertion device with a charging station.

[0047] [Diagram 33] FIG. 33 is a right perspective view showing an example of a charging station for a needle insertion device.

[0048] [Diagram 34] FIG. 34 is a left perspective view showing an example of a charging station for a needle insertion device.

[0049] [Diagram 35] FIG. 35 is a right side elevational view of an example charging station for a needle insertion device.

[0050] [Diagram 36] FIG. 36 is a left side elevational view of an example charging station for a needle insertion device.

[0051] [Figure 37] FIG. 37 is a top elevational view of an example charging station for a needle insertion device.

[0052] [Figure 38] FIG. 38 is a bottom elevational view of an example charging station for a needle insertion device.

[0053] [Figure 39] FIG. 39 is a top end elevational view of an example charging station for a needle insertion device.

[0054] [Diagram 40] FIG. 40 is a bottom end elevational view of an example charging station for a needle insertion device.

[0055] [Diagram 41] FIG. 41 is a right side perspective view showing an example of a medication applicator with a massage head.

[0056] [Diagram 42] FIG. 42 is a left perspective view showing an example of a medication applicator with a massage head.

[0057] [Diagram 43] FIG. 43 is a right side elevational view showing an example of a medication applicator with a massage head.

[0058] [Diagram 44] FIG. 44 is a left side elevational view showing an example of a medication applicator with a massage head.

[0059] [Diagram 45] FIG. 45 is a top elevational view showing an example of a medication applicator with a massage head.

[0060] [Diagram 46] FIG. 46 is a bottom elevational view showing an example of a medication applicator with a massage head.

[0061] [Figure 47] FIG. 47 is a top end elevational view showing an example of a medication applicator with a massage head.

[0062] [Figure 48] FIG. 48 is a bottom end elevational view showing an example of a medication applicator with a massage head.

[0063] [Figure 49] FIG. 49 is a right side perspective view illustrating an example of a medication applicator with a charging station.

[0064] [Figure 50] FIG. 50 is a left perspective view illustrating an example of a medication applicator with a charging station.

[0065] [Figure 51] FIG. 51 is a right side elevational view showing an example of a medication applicator with a charging station.

[0066] [Figure 52] FIG. 52 is a left side elevational view showing an example of a medication applicator with a charging station.

[0067] [Figure 53] FIG. 53 is a top elevation view illustrating an example of a medication applicator with a charging station.

[0068] [Figure 54] FIG. 54 is a bottom elevational view illustrating an example of a medication applicator with a charging station.

[0069] [Figure 55] FIG. 55 is a top end elevation view of an example of a medication applicator with a charging station.

[0070] [Figure 56]FIG. 56 is a bottom end elevational view showing an example of a medication applicator with a charging station.

[0071] [Figure 57] FIG. 57 is a right side perspective view of an example charging station for a medication applicator.

[0072] [Figure 58] FIG. 58 is a left perspective view of an example charging station for a medication applicator.

[0073] [Figure 59] FIG. 59 is a right side elevational view of an example charging station for a medication applicator.

[0074] [Figure 60] FIG. 60 is a left side elevational view of an example charging station for a medication applicator.

[0075] [Figure 61] FIG. 61 is a top elevation view of an example charging station for a medication applicator.

[0076] [Figure 62] FIG. 62 is a bottom elevational view of an example charging station for a medication applicator.

[0077] [Figure 63] FIG. 63 is a top end elevation view of an example charging station for a medication applicator.

[0078] [Figure 64] FIG. 64 is a bottom end elevational view of an example charging station for a medication applicator.

[0079] [Figure 65] FIG. 65 is a right side perspective view showing an example of a massage head for a drug applicator.

[0080] [Figure 66] FIG. 66 is a left perspective view showing an example of a massage head for a drug applicator.

[0081] [Figure 67] FIG. 67 is a right side elevational view showing an example of a massage head for a medication applicator.

[0082] [Figure 68] FIG. 68 is a left side elevational view showing an example of a massage head for a medication applicator.

[0083] [Figure 69] FIG. 69 is a top elevational view showing an example of a massage head for a medication applicator.

[0084] [Figure 70] FIG. 70 is a bottom elevational view of an example massage head for a medication applicator.

[0085] [Figure 71] FIG. 71 is a top end elevational view of an example massage head for a medication applicator.

[0086] [Figure 72] FIG. 72 is a bottom end elevational view of an example massage head for a medication applicator.

[0087] [Figure 73] FIG. 73 is a right perspective view showing another example of a massage head for a drug applicator.

[0088] [Figure 74] FIG. 74 is a left perspective view showing another example of a massage head for a drug applicator.

[0089] [Figure 75] FIG. 75 is a right side elevational view showing an example of a massage head for another medication applicator.

[0090] [Figure 76] FIG. 76 is a left side elevational view showing another example of a massage head for a medication applicator.

[0091] [Figure 77] FIG. 77 is a top elevational view showing an example of a massage head for another medication applicator.

[0092] [Figure 78] FIG. 78 is a bottom elevational view of another example massage head for a medication applicator.

[0093] [Figure 79] FIG. 79 is a top end elevational view of an example massage head for another medication applicator.

[0094] [Figure 80] FIG. 80 is a bottom end elevational view of an example massage head for another medication applicator.

[0095] [Figure 81] FIG. 81 is a right perspective view showing yet another example of a massage head for a drug applicator.

[0096] [Figure 82] FIG. 82 is a left perspective view showing yet another example of a massage head for a drug applicator.

[0097] [Figure 83] FIG. 83 is a right side elevational view showing yet another example of a massage head for a medication applicator.

[0098] [Figure 84] FIG. 84 is a left side elevational view showing yet another example of a massage head for a medication applicator.

[0099] [Figure 85]FIG. 85 is a top elevational view showing yet another example of a massage head for a medication applicator.

[0100] [Figure 86] FIG. 86 is a bottom elevational view of yet another example massage head for a medication applicator.

[0101] [Figure 87] FIG. 87 is a top end elevational view of yet another example massage head for a medication applicator.

[0102] [Figure 88] FIG. 88 is a bottom end elevational view of yet another example massage head for a medication applicator.

[0103] [Figure 89] FIG. 89 illustrates an example of an exploded view of the drug applicator, massage head, and charging station.

[0104] [Figure 90] FIG. 90 illustrates an example of an exploded cross-sectional view of a drug applicator, massage head, and charging station.

[0105] [Figure 91] FIG. 91 illustrates an example cross-sectional view of a drug applicator, massage head, and charging station.

[0106] [Figure 92] FIG. 92 illustrates an example of an exploded three-dimensional cross-section of the drug applicator, massage head, and charging station.

[0107] [Figure 93] FIG. 93 illustrates an example cross-sectional view of a drug applicator, massage head, and charging station.

[0108] [Figure 94]FIG. 94 illustrates an alternative design of a removable fluid cartridge for a medication applicator.

[0109] [Figure 95] FIG. 95 illustrates a perspective view of another example of a needle insertion device enclosed within a needle insertion adapter.

[0110] [Figure 96] FIG. 96 illustrates an exploded view of another example of a needle insertion device enclosed within a needle insertion adapter.

[0111] [Figure 97] FIG. 97 illustrates a cross-sectional view of another example of a needle insertion device enclosed within a needle insertion adapter.

[0112] [Figure 98] FIG. 98 illustrates a perspective view of the internal components of another example of a needle insertion device.

[0113] [Figure 99] FIG. 99 illustrates a close-up view of the internal components of another example of a needle insertion device.

[0114] [Figure 100] FIG. 100 illustrates an exploded view of the internal components of another example needle insertion device.

[0115] [Figure 101] FIG. 101 illustrates a close-up cross-sectional view of another example of a needle insertion device enclosed within a needle insertion adapter.

[0116] [Figure 102] FIG. 102 is a cross-sectional view of another example of a needle insertion adapter.

[0117] [Figure 103] FIG. 103 shows a perspective view of an example needle array.

[0118] [Figure 104] FIG. 104 shows a side elevation view of an example needle array.

[0119] [Figure 105] FIG. 105 shows a bottom end elevation view of an example needle array.

[0120] [Figure 106] FIG. 106 illustrates a perspective view of another example of a medication applicator including a massage head and a charging station.

[0121] [Figure 107] FIG. 107 illustrates a cross-sectional view of another example of a medication applicator including a massage head and a charging station.

[0122] [Figure 108] FIG. 108 shows a cross-sectional view of another example of a medication applicator.

[0123] [Figure 109] FIG. 109 shows an enlarged perspective view of the internal components of another example of a medication applicator.

[0124] [Figure 110] FIG. 110 illustrates a cross-sectional view of an example cartridge for use with a medication applicator.

[0125] [Figure 111] FIG. 111 illustrates a perspective view of an example cartridge for use with a medication applicator.

[0126] [Figure 112] FIG. 112 illustrates a perspective view of an example of a cam for use with a medication applicator.

[0127] [Figure 113]FIG. 113 shows a cross-sectional view of another example of a medication applicator with a massage head.

[0128] [Fig. 114] FIG. 114 shows a close-up view of an example of an attachment between a drug applicator, its cartridge, and its massage head.

[0129] [Figure 115] FIG. 115 shows a bottom perspective view of another example of a massage head for use with a medication applicator.

[0130] [Fig. 116] FIG. 116 shows a top perspective view of another example of a massage head for use with a medication applicator. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0131] 5. DETAILED DESCRIPTION OF THE PRESENTINVENTION Before describing at least one embodiment of the present invention in detail, it will be appreciated that the present invention may be practiced in a variety of applications. However, the details of construction and the arrangement of components set forth in the following description or illustrated in the drawings may be varied without departing from the spirit and scope of the invention. It should be understood that the drawings and written description are not intended to be limiting. to teach any person of ordinary skill in the art to make and use the invention for which patent protection is sought. The invention is capable of other embodiments and of being carried out in various ways. It is possible to implement and practice the invention as described above. Those skilled in the art will appreciate that the invention may be practiced and practiced in a commercially available manner for clarity and understanding. It will be appreciated that not all features of an embodiment are shown. The development of an actual commercial embodiment incorporating aspects of the invention involves a number of practical steps, i.e. that specific decisions are required to achieve the ultimate goal of the developer of the implementation We will admit that these efforts can be complex and time-consuming, but they are worth it. Indeed, these efforts would be routine undertakings for those of ordinary skill in the art having the benefit of this disclosure. It will be.

[0132] Additionally, the phraseology and terminology employed herein is for purposes of description and It should be understood that the above should not be construed as limiting. For example, singular terms, e.g. For example, the use of "a" is not intended as a limitation on the number of items. Examples include, but are not limited to, "top", "bottom", "left", "right", "upper Relationships such as "upper," "lower," "down," "up," and "side" The use of the terminology is used herein for clarity with specific reference to the drawings. These are used in a general sense and are not intended to limit the scope of the invention or the appended claims. Furthermore, any one of the features of the present invention may be used alone or in combination with another feature. It should be understood that, upon examination of the drawings and detailed description, one skilled in the art will understand the present invention. Other systems, methods, features, and advantages will be or will become apparent. All such additional systems, methods, features, and advantages are included herein and are incorporated by reference in their entirety. It is intended that this invention be within the scope of the invention and be protected by the following claims.

[0133] (5.1 Needle insertion device) The needle insertion devices described herein are useful in hair growth applications, wrinkle removal, scar removal, hair removal, tattoo removal, and other similar applications. The needle insertion devices described in this application may be used in several different procedures, including removal, and pigmentation. Advantages of the device include a reusable main unit or a removable sheath or adapter. The device protects the needle insertion device and protects the patient or The needle insertion device described in the present application provides ease of use by the physician. Methods for using are provided in more detail in Section 5.4 below.

[0134] 5.1.1 Exemplary Embodiments of Needle Insertion Device With reference to FIG. 1, by way of non-limiting example and consistent with embodiments of the present invention, several In this embodiment, even the micropen 100 used for microneedle insertion The needle insertion device 100 includes a main body 110, a power interface 111, a charging contact 112, a first measurement A first dial 113 for needle adjustment with a value indicator 114, a second dial 116 with a measurement value indicator A second dial 115 for needle adjustment, and a light path in a direction parallel to the longitudinal axis of the micropen 100. A light pipe 117 is provided for providing illumination.

[0135] In one example, the micropen body 110 is made of aluminum with an anodized black or matte anodized finish. The shape and size of the micro pen body 110 may be, but are not limited to, a micro pen body made of a material such as aluminum. The outline and shape of the micro pen body 110 used with the adapter 200 described below are also The user has improved control and handling of the micro-pen 100 during the micro-needle insertion operation. This makes it possible.

[0136] Referring to FIG. 2, the micro pen 100 includes an adapter body 210, a power interface 211, A micro pen connection part 212, a lower body 213, a needle insertion head 214, a head cover 215, and a needle insertion Used with a corresponding needle insertion adapter 200 having several needles 216 on a head 214 The adapter 200 may be formed from a variety of different materials. 00 is made of polycarbonate or another plastic material. The needle 216 is also made of various The needle may be formed from a variety of different materials, one example includes a needle formed from a high carbon steel material. The micro pen 100 is inserted into the adapter 200 before the needle insertion operation, and the connecting portion 212 is , covering the second dial 115, and the lower body 213 covering the first dial 113. The connecting portion 212 and the lower body 213 are inserted in such a manner that the connecting portion 212 and the lower body 213 are connected to each other. The second dial 115 and the first dial 113 are rotated and controlled by the rotation of the second dial 115 and the first dial 113, respectively. In addition, the connecting portion 212 and the lower body 213 are rotatable relative to the adapter body 210. Preferably, the user controls the first and second dials 113, 115. and are transparent so that the measurements on the corresponding measurement indicators 114, 116 can be viewed.

[0137] The first dial 113 and the second dial 115 may be used for various adjustment functions of the needle 216. Preferably, the needles 216 can be adjusted for penetration depth and density. However, other adjustments, such as needle insertion speed, may be available to the user. In the example, the first dial 113 has an indexing angle and therefore a pointer 216 The first dial 115 is used to adjust the density of the needle 216, and the second dial 116 is used to adjust the penetration depth of the needle 216. Density is the ratio of perforations per square area in one arrangement to another. For example, rotation of the second dial 115 adjusts the needle insertion head 2 14 and thereby causes the needles to be placed on the needle insertion head 214 with different densities. However, because the needles 216 are distributed, the density of the needle penetrations is controlled. It should be appreciated that other mechanisms for detecting the presence of the first adapter may be implemented. A different needle penetration density is provided using the first adapter than using the second adapter. Adapters 200 having different types of needle insertion heads 214 may be available.

[0138] In one example, for ease and simplicity for the user, a square area of ​​the target surface is Density control of the number of disturbances or skin perforations per unit time is available in low, medium, and high density configurations. The density of needle penetration as referred to herein refers to the density of the needle penetration at a given time during the needle penetration procedure and at the same time as the density of the target tissue. It is determined by the number of needles 216 that contact the subject's skin per square area of ​​skin. The density may vary in value, and in one example, the density has a value of: The percentage of the skin perforation surface area varies from 1% to a percentage of 40%. The percentage is at least 1%, At least 5%, at least 10%, at least 15%, at least 20%, at least 25%, At least 30%, at least 35%, at most 5%, at most 10%, at most 15%, at most It may include at most 20%, at most 25%, at most 30%, at most 35%, or at most 40%. Thus, the first dial 113 may include indicia corresponding to low, medium, and high density configurations, or may include a percentage indicia indicating the percentage of skin perforation.

[0139] In one embodiment, the overall movement of the needle 216 is along a z-axis parallel to the longitudinal axis of the micropen 100. The needle 216 then retracts and then retracts to a predetermined position. Index through a predetermined angle, Θ e Θ). The process then continues until the desired needle penetration density, which is set by the first dial 113, is reached. This is repeated for a period of time until

[0140] 3-8, various views of the micropen 100 are provided. The micro pen body 110 is connected to a rechargeable battery or other power unit, a first die, A motor and a drive mechanism between the first dial 113 and the second dial 115, and a motor and a drive mechanism between the first dial 113 and the second dial 115, The power interface 111 may also include a printed circuit board or control circuit. In an example, as shown in FIG. 8, a light pipe 117 is provided on the bottom surface of the micro pen 100. This is because the light is projected from the light pipe 117 through the adapter 200. allows the user or operator to view the needle insertion tip of the device during the needle insertion procedure. FIG. 7 shows a marker that may have curves or contours for ease of design and handling functionality. The solid top surface 118 of the micropen 100 is shown.

[0141] 9-16, various views of a micropen 100 with an adapter 200 are provided. Specifically, referring to FIG. 9A and FIG. 9B, the disconnection of the micro pen 100 and the adapter 200 is performed. An example of surface overlap is given.

[0142] 9A and 9B, the head cover 215 is tapered and made of transparent plastic. The material allows the user to see the needle 216 under the head cover 215 during the needle insertion procedure. 11 to 16, various micropens 100 combined with an adapter 200 will be described. Various diagrams are shown.

[0143] 17-24 show further diagrams of a needle insertion adapter 200 for use with the micropen needle insertion device 100. 17 to 18, the connection portion 212 receives the micro pen 100. The above-mentioned combination device is configured to be provided. FIG. 23 shows the connection portion 2 of the adapter 200. 12 shows a top view of the adapter 200 including needle 216 and FIG. 24 shows a bottom view of the adapter 200 including needle 216.

[0144] 25 to 40, the charging station 300 also has a function for charging and communicating with the micro pen 100. The micro pen 100 is directly inserted into the charging station 300, as shown in FIG. A combination structure as illustrated in FIG. 32 may be provided. a station body 310, a station base 311 for placement on a table or other surface, and Station electrical connection 312, which illuminates station 300 when micropen 100 is inserted The charging station 300 includes a lighting ring that illuminates the area around the charging station 300. The lighting ring illuminates the area around the charging station 300 with different levels of illumination. Different levels of charging of the cross pen 100 may be indicated. Additionally, the lighting level may indicate when charging is complete. A different color light may be used to indicate when this is the case.

[0145] As shown in FIGS. 25A and 25B, the micro The flush design of the pen 100 allows for aesthetically pleasing placement and user interface of the combination device. The bottom surface 311 allows the combination device to be placed flat when not in use. This allows the equipment to be placed upright or stowed away.

[0146] 33 to 40, various examples of the charging station 300 without the micro pen 100 are shown. The charging station 300 detects whether power and charging are in operation. 33 and 34, the upper portion 313 is provided with an indication portion 314 for indicating the The station 300 is configured to receive the pen 100. The exchange allows you to charge the MicroPen 100 as well as perform other functions, such as data transfer. It should be appreciated that, referring back to FIG. 2, the four charging contacts 112 are , ground, data, and overcharge contacts.

[0147] FIG. 95 illustrates the needle insertion adapter 800, also referred to as the sheath assembly, in an assembled state. Enclosed within is another micropen needle insertion device 700 (not visible), also referred to as the main unit. FIG. 96 shows a perspective view of an example of a needle insertion adapter 800 in a disassembled state. FIG. 7 shows an exploded view of the enclosed micropen needle insertion device 700.

[0148] Referring to FIG. 95, the needle insertion device 700 is configured such that all parts of the needle insertion device 700 are protected from the external environment. The needle is completely enclosed in the needle insertion adapter 800 so that the user can The user or physician is provided with a device capable of being maintained in the most sterile conditions. The insertion device 700 may be used with a first needle insertion adapter 800 on a first subject, Thereafter, the needle insertion device 700 is inserted into a second subject while remaining completely protected from the external environment. In order to use the needle insertion adapter 800, the first needle insertion adapter 800 is removed and replaced with a second needle insertion adapter. Before being removed from the packaging, the needle insertion adapter 800 is provided in sterile conditions. This means that the system can be used by clinics, physicians, or users to sterilize equipment. In another example, the needle insertion device 700 may be used in the same manner as in the For each of the animals, different types of needle insertion adapters 800 having different types of needle insertion arrays are used. That is, the patient may use the needle insertion adapter 800 for hair growth applications, and Thereafter, the needle insertion device 700 is fully enclosed and protected from the external environment during use. It can be used with different needle insertion adapters for tattoo or scar removal without the need to sterilize it. This allows for ease of use and interchangeability, and reduced production. Among other benefits, such as cost, it provides at least the prevention of cross contamination.

[0149] Referring to FIG. 96, in some embodiments, a micropen needle insertion device 700 is provided. The needle insertion device 700 includes a micro-pen body 710, a micro-pen cap 720, and a control The one or more buttons 730 are provided for controlling the insertion depth or needle insertion. a button for controlling the speed of the needle insertion operation or the disturbance applied to the subject's skin; a needle insertion device 70 0 power on / off button, light coming out of the distal end of the needle insertion device 700 to illuminate the disturbed area. and power control of the light tube that enables the needle insertion mechanism to be a power button for powering on and powering off the needle insertion mechanism when released by a user; In one example, needle penetration depth adjustment can be performed by a user. The adapter cap 820 is rotated to control the position of the adapter cap 820. 98, the micropen cap 720 and the model are then Rotate the tertiary chassis 740.

[0150] Also, referring to FIG. 96, the needle insertion adapter 800 includes an adapter body 810, a micro paint An adapter cap 820 for controlling and / or rotating the cap 720, an enclosed needle cap One or more buttons 830 for controlling one or more buttons 730 of the input device 700, and a circumference of a plurality of needles 842. The needle housing 840 includes a needle cover 842 for covering and protecting the needle. A transparent needle cover (not shown) having the same shape as the housing may be received. The adapter cap 820 and one or more buttons 830 of the needle insertion device 700 are respectively 7, cooperates with a micro pen cap 720 and one or more buttons 730. More specifically, in one example The adapter cap 820 rotates to rotate the micro pen cap. A protrusion (FIG. 97) that interacts with a groove 722 in the micropen cap 720 to cause rotation of 720. In addition, the user can insert the needle into one or more buttons of the needle insertion adapter 800. The needle insertion device 700 may be inserted into the needle insertion opening 830 by pressing the tab 830 to control the operation of the needle insertion device 700 while it is wrapped. One or more buttons 830 of the needle insertion adapter 800 cover and / or support one or more buttons 730 of the needle insertion device 700. In another example, the needle insertion device 700 can be operated by pressing a button on the needle insertion adapter 800. 830 controls the needle insertion operation without pressing an internal button, without the need for a button 730. and forming the needle insertion adapter 800 to be remotely connected via a wireless connection. can be done.

[0151] FIG. 97 shows a cross-sectional view of the needle insertion device 700 enclosed within the needle insertion adapter 800. do.

[0152] Referring to FIG. 97, needle insertion device 700 includes a battery or power supply for powering device 700. A supply mechanism 724, a battery clip 725 for holding the battery 724 in position, and the battery 724 in position as shown in FIG. and for powering a needle insertion operation as described in more detail below with reference to FIG. The needle insertion adapter 800 of this embodiment further includes a motor 726. A biological barrier 812 as an additional layer of protection and sealing for the insertion device 700 and connected to the needle 842 and a drive shaft 712 that can be removably attached to the drive shaft 712 of the needle insertion device 700. The drive shaft interface 814 includes a drive shaft. Interaction with the needle 712, for example by a male-female coupling, occurs when it is positioned within the needle insertion device 700. After the needle insertion device 700 is inserted and pushed completely into the needle insertion adapter 800, The sensor can be securely attached to the controller 800 with a clicking sensation and / or sound. gives users confidence that the equipment is securely fastened together and ready for use This positive engagement reduces vibration within the device and facilitates a higher quality procedure. A needle array connection means is provided.

[0153] FIG. 98 illustrates a perspective view of the internal components of needle insertion device 700.

[0154] Referring to FIG. 98, the internal components of the needle insertion device 700 include the micro-paint as described above. Included are a cap 720, a battery 724, a battery clip 725, and a motor 726. The needle insertion device 700 includes a motor shaft 718 extending from a motor 720. Angled hub 716 secured to hub 718; The motor includes a swing plate 714 that swings the swing plate 714, and a drive shaft 712 that is connected to the swing plate 714. 726, motor shaft 718, angled hub 716, wobble plate 714, and drive shaft 712. The internal components of the needle insertion device 700 are configured to hold all the components together, including and are connected by a chassis 740 which moves the components along the longitudinal axis of the needle insertion device 700. The chassis 740 is configured such that rotation of the micropen cap 720 in one direction rotates the internal components around the axis. The device moves in one direction toward or away from the subject's skin and moves in the opposite direction. The chassis is rotated such that rotation of the MicroPen cap 720 moves the internal components in opposite directions. The micro-pen may be attached to the micro-pen cap 720 by a pin 742. and then the disturbance of needle 842 using motor 726 and corresponding actuation mechanisms 712, 714, 716, 718. Before the stroke is initiated, the penetration depth of the needle 842 is controlled.

[0155] FIG. 99 shows an enlarged view of the actuation mechanisms 712, 714, 716, and 718 of the needle insertion device 700. 7 illustrates an exploded view of the actuation mechanisms 712, 714, 716, 718 of the needle insertion device 700.

[0156] As explained above and best seen in FIG. 100, the motor shaft 718 Extending from the rotor 720 is an angled shaft 716 which is fixedly attached to the motor shaft. The wobble plate 714 is rotated by a pivot 718, which is attached to a rotating element 718 fixed to an angled shaft 716. Rotating element 714a and non-rotating element 714b are connected to drive shaft 712. Element 714b is connected by a bearing element. When the motor shaft 718 rotates, The angled shaft 716 is rotated by a motor shaft 718. Element 714b moves toward and away from the subject's skin surface with each rotation of motor shaft 718. The degree of vibration determines the amount of needle holder available for needle insertion. The stroke length of the actuator 844 is defined.

[0157] 101, the attachment of needle 842 to drive shaft 712 will now be more clearly explained. The needle 842 is mounted on a needle holder 844 that is secured to the drive shaft interface 814. The drive shaft interface 814 is arranged in an array. Axial displacement of shaft 712 causes drive shaft interface 814, needle holder 844, and A needle 842 is removably attached to the drive shaft 712 to cause axial displacement of the needle 842. The biological barrier 812 is also securely attached near the needle holder 844 and is secured to the needle holder. The actuator 840 may be configured to move axially with the actuator 844. Other components shown include , the adapter body 810 already described, the biological barrier 812, the needle housing 840, the micropen body 7 10, actuation mechanisms 712, 714, 716, 718, and a motor 726.

[0158] FIG. 102 is a cross-sectional view of the needle insertion adapter 800 without the needle insertion device 700. The needle insertion adapter 800 includes an adapter having a needle housing 840 that is securely attached to one another. Adapter body 810 and adapter cap 820, one or more buttons 830, drive shaft interface The needle insertion adapter 800 includes a face 814, a needle holder 844, and a needle 842. and is intended for a single treatment session. The needle 842 and needle holder 844 may be The needle holder 844 may have different shapes and configurations. In this example, the needle holder 844 is rectangular and holds the needle 842. are arranged in two parallel rows.

[0159] 103, 104, and 105 show various views of needle 842 and needle holder 844. As shown in FIGS. 103-105, the needle 842 extends from one end of a rectangular needle holder 844 to the other end of the holder. The needles are arranged in two parallel or substantially parallel rows on a rectangular needle holder 844. Substantially parallel as used herein means within a range of plus or minus 10%. There are 12 needles 842, six needles 842 on a first row 846 and six needles 842 on a second row 847. Also, the needles 842 in the first row 846 are horizontally spaced apart from the needles in the second row 847. 8, the needles 842 in the second row 847 are offset from the needles 842 in the second row 847 so as to be between and equidistant from the needles. In other examples, more than two rows may be used. In one example, the needles 842 are arranged in a single horizontal row. The distance covered by needles 842 exceeds the distance covered by a vertical row of needles 842 In another example, the needle holders are arranged in a rectangular configuration as shown in the examples of Figs. The holder may have a circular shape such that the needle 216 is positioned on the holder. good.

[0160] The advantage of having needles 842 and needle holders 844 arranged in a rectangular configuration is that the user or One advantage of using a needle is that it allows the physician to view the target area during the needle insertion procedure. In another example, the shape of the needle holder is as opposed to a rounded needle arrangement or a circular needle array. In contrast, the user is required to follow a more strict needle insertion pattern of a series of non-overlapping straight lines. This also provides a faster and more efficient needle insertion operation.

[0161] 5.1.2 Aspects of the Needle Insertion Device Embodiments Described In one embodiment, the needle insertion device and needle insertion adapter described in all the above embodiments The target is suitable for promoting hair follicle neogenesis by targeted skin perturbation (TCP) of the skin (e.g., scalp). In specific embodiments, the TCP is provided in one or more epidermal layers (see, e.g., Sections 5.3 and 5. 4), for example, refers to integumentary perturbation of the basal and / or suprabasal layers of the epidermis. In a preferred embodiment, the needle insertion device and needle insertion adapter described herein may be used. Integumentary perturbation, which is performed by the application of a compound (see, for example, Section 5.6) to the skin, Without being bound by any particular theory, TCP is Triggering the production of new hair follicles by inducing cells. For example, integument disruption and needle insertion devices For a more detailed explanation of how to use the needle insertion adapter, see Sections 5.3 and 5. In another example, the needle insertion device and needle insertion adapter or a different arrangement A replaceable needle insertion adapter (e.g., the needle array shown in the examples of FIG. 18 and FIG. 24) having a needle array (which are used for other purposes, such as wrinkle removal, scar formation, hair removal, and tattoo removal) possible.

[0162] In one example, the needle insertion device and needle insertion adapter of all embodiments are combined. A rechargeable, battery-powered, handheld device may be formed. The device may be used to measure needle arrays. TCP is performed by inserting and removing the scalp in a reciprocating motion to "injure" the scalp. The handpiece assembly includes a durable and reusable needle insertion device and A single-use needle insertion device that also acts as a protective barrier to prevent exposure to blood or other contaminants. Comes with a needle insertion adapter.

[0163] In one example, the needle insertion device of all embodiments is adapted to re-use a previously used needle insertion adapter. To prevent use, check whether the needle insertion adapter is a needle insertion adapter that has already been used. The needle insertion device and / or the needle insertion adapter may include a sensor for detecting the presence of a needle. determining when to power off the device and automatically moving the needle in response to the device being powered off; A controller is also provided for retracting and / or adjusting the needle penetration depth to the most retracted position. The needle insertion device can be fitted to the needle array to guide movement through the subject's hair. For example, the guide may be used in combination with a clipper attachment. This limits lateral movement of the needle insertion device, and Guide the user's hand in motion using straight strokes.

[0164] The adapter in all embodiments is a separate component of the combined device, but the needle insertion device Provides complete isolation of the needle insertion head from the needle. Because the sheath is removable and disposable, it prevents blood contamination of the needle insertion device. and prevent cross-contamination between separate users of the needle insertion device. The device reduces the amount of time required to initiate a needle insertion procedure. Once removed from its packaging, the physician receives a pre-sterilized sheath or adapter. In order to prevent the needle insertion device unit from being accidentally inserted into the sheath, the sheath can be used with another sheath or adapter immediately after the needle insertion device unit is inserted. This is to protect the primary needle insertion device unit from any contamination so that the primary needle insertion device unit can be easily inserted. This feature allows for safe and easy use of the device.

[0165] In one example, the needle penetration speed may include three discrete speeds (60 Hz, 100 Hz, 140 Hz). The frequency of the needle insertion should be at least 60 Hz and may range from 60 Hz to 140 Hz. 0Hz, at least 70Hz, at least 80Hz, at least 90Hz, at least 100Hz, at least 110Hz, at least 120Hz, at least 130Hz, at most 70Hz, at most 80Hz, at most 90Hz z, at most 100Hz, at most 110Hz, at most 120Hz, at most 130Hz, and at most 140Hz In addition, the needle penetration depth adjustment is a gradual needle penetration depth adjustment (skin surface This may include 0.5 mm above the skin surface and 2.5 mm below the skin surface. When in the retracted position, the needle is fully retracted and the device is not moved by the user. The dragging of the needle through the subject's skin so that the needle is not dragged through the subject's skin while the needle is in the skin Reducing drag and having a target area illumination source is a more Providing quality procedures and more precise, consistent needle placement.

[0166] With regard to needle penetration depth control, a variety of different penetration depth adjustments may be available. In one embodiment, the penetration depth is between 0.5 mm and 2.5 mm in the retracted position. however, needle penetration depths are available in a wider range. For example, the penetration depth can be measured from the fully retracted needle position. The range may include from -0.5 mm to 5 mm or more. The depth is at least -0.5 mm, at least 0 mm, at least 0.5 mm. at least 1 mm, at least 1.5 mm, at least 2 mm at least 2.5 mm, at least 3 mm, at least 3.5 mm Torr, at least 4 mm, at least 4.5 mm, at most 0.5 mm le, at most 1 mm, at most 1.5 mm, at most 2 mm, At most 2.5 mm, at most 3 mm, at most 3.5 mm, at most 4 mm The distance may include at most 4.5 millimeters, or at most 5 millimeters.

[0167] In one embodiment, the needle insertion device or needle insertion adapter described herein is adapted to penetrate the skin by 30 Penetration depths from 30 μm to 200 μm (e.g., 30, 40, 50, 60, 70, 80, 85, 90, 95, 100, 1 05, 110, 120, 130, 140, 150, 160, 170, 180, 190, or 200 μm maximum depth), preferably In one embodiment, the method described herein is suitable for breaking the particles into particles having a diameter of about 100 to 150 μm. The needle insertion device or needle insertion adapter is suitable for disrupting the skin to a depth of 100 μm. In one embodiment, the needle insertion device or needle insertion adapter described herein has a diameter of 150 μm. Suitable for destroying the skin to a depth of

[0168] 5.2 Applicator Device Examples of needle insertion devices and other components including adapters and charging stations have been described. Next, use a fluid or drug applicator, drug applicator and massager head, a cartridge for use with a drug applicator, and a drug applicator refill The description of the electrical charging station will now be described with reference to the remaining figures. The drug applicator may be used with any type of fluid. The researchers used a variety of different chemicals to apply minoxidil to the subject's scalp. All drug or fluid applicators are used for other purposes. With respect to this embodiment, any type of fluid may be used, and the invention is not limited to the use of drugs. It should be recognized that the term "device" is not intended to be construed as limiting the scope of the invention. "material applicator," "fluid applicator," or simply "applicator." Methods of using the applicator devices described in this application are described in Section 5. below. 4 provides more detail.

[0169] In one embodiment, the drug applicator is combined with another drug or treatment that stimulates hair growth. For example, hair growth promoters for use according to this embodiment, alone or in combination, may be used. For: Drugs that affect prostaglandins, e.g., prostaglandin F2α analogues For example, latanoprost (trade name Xalatan), travoprost (trade name Travatan), tafluprost, Prost, Unoprostone, Dinoprost (trade name Prostin F2 Alpha), AS604872, BOL 303259X, PF3187207, Carboprost (trade name Hemabate); Prostamides, e.g., Bimato prostanoid receptor agonists, e.g., fulvic acid (Latisse, Lumigan); Rostenol; Prostaglandin D2 receptor antagonists, e.g., Laropiprant, A M211; Prostaglandin E2 analogues, such as sulprostone; and EP2 receptors receptor agonists, e.g., butaprost; 5α-reductase inhibitors, e.g., finasteride , dutasteride, turosteride, bexalosteride, izonsteride, epristeride , epigallocatechin, and fluridil (Sovak et al., Dermatol Surg. 2002;28(8):678-685) , RU 58841 (Pan et al., Endocrine. 1998;9(1):39-43), N,N-diethyl-4-methyl-3-oxidase So-4-aza-5 alpha-androstane-17 beta-carboxamide (Rittmaster et al. J Clin Endocrinol Metab. 1987;65(1):188-193), MK-386, azelaic acid, FCE 28260, S KF 105,111; Minoxidil; ATP-sensitive potassium channel openers, e.g., diazoxide; and a hair growth promoter as described herein or otherwise known in the art; For example, kopexil (e.g., the product Keranique®), CaCl2, botulinum toxin A (boti linum toxin), adenosine, ketoconazole, DoxoRx, docetaxel, FK506, GP11046, GP11511, LGD 1331, ICX-TRC, MTS-01, NEOSH101, HYG-102440, HYG-410, HYG-420, HYG- 430, HYG-440, Spironolactone, CB-03-01, RK-023, Abatacept, Viviscal (registered trademark) Marker), MorrF, ASC-J9, NP-619, AS101, Metron-F-1, PSK 3841, Targretin (e.g., 1 % gel), MedinGel, PF3187207, BOL303259X, AS604872, THG11331, PF-277343, PF-3004 459, Raptiva, caffeine, and coffee. Hair growth promoters include arginine, isoleucine, leucine, lysine, methionine, and phenanthrine. Nitralanine, threonine, tryptophan, valine, gamma-linoleic acid and polyphenols These include copper catechin and copper peptide. They can be formulated as hair washing tonics. Hair growth stimulants include jojoba oil, apple extract, saw palmetto, emu oil, beta These include, but are not limited to, carotene, and green tea. The applicator will be used with a drug for alopecia being developed by SWITCH Biotech LLC. They may also be used in combination.

[0170] Other compounds that may be used with the applicator include those from the following companies and company IDs: elion ACT-129968 (setipiprant), Actimis AP768, Amira AM211, Amira AM461, Amgen AMG853, Array BiPharma ARRY-502, AstraZeneca AZD1981, AstraZeneca AZD8075, Astr aZeneca AZD5985, Merck MK-7246, Novartis QAV680, Oxagen OC000459, Oxagen OC00241 7. Pulmagen ADC3680B, Shionogi S-555739, BBI-5000, SM04554, and KYTH105 (Cechip Examples of compounds that can be identified by the

[0171] In specific embodiments, other compounds that may be used with the applicator include those described below. In a specific embodiment, the agent is an agent described in Section 5.6 of the present invention. The compound(s) that may be used with the licator are described in Section 5.7 below. In such a dosage.

[0172] 5.2.1 Exemplary Embodiments of the Applicator Device 41 to 48, the applicator 400 to which the massage head 500 is attached is Various views of the applicator 400 are provided. The applicator 400 comprises polycarbonate. The massage head 500 may be made of one or more different materials, including but not limited to synthetic rubber. , silicone, and low durometer plastic. The applicator 400 may be made of a material that is suitable for application to a wide range of medical devices. The applicator components are described in more detail below with reference to Figures 89-93. The massage head 500 includes a massage head body 510 and several The massage protrusions 511 and 512 are provided with a closing protrusion 512 and The device includes an aperture 511 that provides a flow of compound directly to the scalp of the subject. The apertures in the aperture 511 include , directly at the base of each protrusion 511 and therefore directed to the subject's scalp rather than to the subject's hair. This allows direct access to the

[0173] 49-56 show various views of the applicator 400 disposed within the charging station 600. The charging station 600 includes a charging station main body 610 and a charging station bottom plate 612. The bottom surface 612 is curved and has a central portion where the charging station 600 is attached to a surface or tape. Station 600 may have a flat area that allows the user to stand upright on the bull. Although available in a variety of different colors and materials, in one example, charging station 600 is transparent. and can be illuminated by light emitted from the applicator 400. See FIG. As will be described in more detail below, the applicator 400 may be configured to charge the applicator 400. The transparent charging device may also include an LED ring 430 that becomes brighter as charging progresses. Detect the amount of charge on the applicator 400 based on the increased illumination of the station 600. obtain.

[0174] 57-64 show various views of the charging station 600 without the applicator 400. Referring to FIG. 57, a charging station 600 is provided to house and connect the applicator 400. The charging station has a top 611 for connecting to a charger. A bottom 612 is also shown in Figures 58 and 64. 600 is a dock that provides a base for the applicator 400 to charge. The charging station 600 can be plugged in when needed.

[0175] As shown in FIG. 93, the LED ring 430 of the applicator 400 can be used to activate the charging switch in a variety of ways. For example, light from the LED ring 430 may shine to illuminate the subject or user. This may indicate that it is time for the user to use the device. When the applicator 400 is lifted out of the charging station 600, The lights will be turned off to allow the subject to proceed. Once back inside Station 600 Once power is turned on, another notification may indicate the power or fluid level and inform the subject or user of the next In addition, when the applicator 400 is in the station 600, The applicator 400 may be rotated to adjust the intensity of the chemical delivery. The intensity may be adjusted to match the user's settings. The applicator 400 supports Bluetooth LTE. It may also be controlled by connection to a smartphone or smart device via.

[0176] 65 to 72 show various views of the first massage head 500 without the applicator 400. 62 and 63, the massage head 500 is a massage head main body. A body 510, an opening protrusion 511, a closing protrusion 512, a massage head connection surface 513, a male connection protrusion 514, and The massage head has a central opening 515. The connecting surface 513 is adapted to receive the applicator 400. 90, and the connecting projection 514 is adapted to be connected to the applicator 400 452. Also known as the smart head. The massage heads 500 are interchangeable and can be adjusted to suit hair type, regrowth goals, and comfort. The opening protrusion 511 is provided with a dispensing tip and, in this example, has three There are open protrusions 511. Closed protrusions 512 are for combing and massaging. The image forming head 500 may also include two sensor tips formed from a carbonized rubber material. It can tell when the chip comes into contact with the skin and automatically initiate activation.

[0177] 73 to 80 show various views of the second massage head 500b without the applicator 400. 73 and 74, the massage head 500b is a massage head main body. Body 510b, open protrusion 511b, closed protrusion 512b, massage head connection surface 513b, and male connection protrusion 514b. The connection surface 513b is for receiving the applicator 400 and is The protrusion 514b is adapted to be mated with a corresponding female connecting portion 452 of the applicator 400 as shown in FIG. It is for connection.

[0178] 81 to 88, a third massage head 500c without the applicator 400 is shown. 81 and 82, the massage head 500c includes a massage head body. 510c, massaging protrusions 511c, massage head connection surface 513c, male connection protrusions 514c, and The connecting surface 513c is adapted to receive the applicator 400. The connecting protrusion 514c is for connecting the applicator 400 as shown in FIG. This third massage head 500c is for connection to a corresponding female connection portion 452. , helping users locate areas of male pattern baldness.

[0179] A description of the components of applicator 400 will now be given with reference to Figures 89-90. The applicator 400 includes a removable cartridge 450 in the central portion of the applicator 400. The cartridge 450 may be used for minoxidil solution or another type of fluid. stomach.

[0180] The removable cartridge 450 is adapted for connection with the male portion 514 of the massage head 500. The cartridge 450 may also include a transparent top for indicating the fluid level. Alternatively, the fluid level can be displayed to the user via an LED display. The cartridge 450 also preferably has a cartridge 452 as shown in FIG. The massage head 500 is provided with a protrusion that can match the protrusion of the massage head 500. It has an open tip for direct fluid ejection via projection 511 .

[0181] Referring again to Figures 89 and 90, the drug applicator 400 includes a power supply and actuation mechanism 4 The inner body 460 includes an inner wall 462 and an inner wall 464 for receiving the massager 62 and the massager 464. An operating mechanism 4 such as a motor and an actuator for controlling the rotational state of the head 500 62. The inner body 460 may also include a charger 64 for powering the applicator 400. The drug applicator 400 may further include a power supply mechanism 464, such as an electric battery. for releasing a chemical agent through the drug applicator 400 and the massage head 500. Several different delivery mechanisms, such as those used in syringes, are available. The device may use a movable piston, a vacuum system to draw fluid, or other pumping mechanism. The drug applicator 400 may include a power button for turning it on and off. In one example, the drug applicator 400 may be configured to receive a drug upon contact with a user or a tap on the device. It may be turned on and off via a switch interface.

[0182] Referring now to FIG. 93, an applicator 400 includes a tri-color LED array 430 and a light panel. As already explained in paragraphs

[0173] and

[0175] , the LED array The charging station 430 interacts with the charging station 600 to provide various functions and notifications to the user. This is also fine.

[0183] Referring to FIG. 94, another embodiment of an applicator 400 is shown having a cover 4 on the top of the applicator. 11, a cartridge 450 removably attached to the top of the applicator 400. or in combination with the massage head 500, a combined disposable cartridge and and a cartridge 450 that provides the massage head structure.

[0184] FIG. 106 illustrates a drug applicator 900 with a massage head 940 and a charging station 930. FIG. 13 is a perspective view of another example of 00.

[0185] Referring to FIG. 106, a drug applicator 900 includes an applicator body 910, a drug applicator A keypad 905 with buttons for powering and controlling the operation of the computer 900, and a charging A charging station 930 is provided to receive the drug applicator 900 for charging. A power button to turn the device on and off, and a power button to control the massage speed Speed ​​buttons and settings for massage only and massage and dispense modes The device may include one or more mode buttons for setting a mode of operation such as. In the example, the rates include three discrete rates: 1 Hz, 2 Hz, and 4 Hz. may operate using inductive charging as described in more detail with reference to FIG. 107. .

[0186] FIG. 107 illustrates a drug applicator 900 with a massage head 940 and a charging station 930. FIG. 108 shows a cross-sectional view of the massage head 940. FIG. 9 shows a cross-sectional view of drug applicator 900 without 930.

[0187] 107 and 108 together, the drug applicator 900 includes a controller 912, a position A sensor 913, a motor 914, a motor shaft 915, and a motor for powering the drug applicator 900. a battery or power supply mechanism 916 for holding the one or more rollers 911b; A frame 911 (shown in FIG. 109), a drive key 918 attached to a motor shaft 915, a drive A cam drive 921 that receives the key 918 and supports the roller 911b, An internal cavity 919 for receiving a cartridge 920 from which liquid is dispensed. a cartridge actuator 922 configured to be actuated to While the applicator 900 is being charged in the charging station 930, the applicator The applicator body 910 is formed around the upper peripheral portion thereof such that it is visible 360 ​​degrees around the body 910. In one example, the LED ring 917 indicates whether the device is powered on. The light may indicate whether the device is charging or not, and may vary in intensity depending on the level of charge of the device; i.e. As the device progresses in charging at the charging station 930, the light may gradually increase.

[0188] Referring solely to FIG. 107, the drug applicator 900 can be inductively charged; i.e., using an electromagnetic field. The charging station 930 transmits energy to the drug applicator 900 by electromagnetic induction. The charging station 930 includes a charging coil 932. The drug applicator 900 may also interact with a charging coil 932 of the charging station 900. A corresponding coil 934 may be provided for detecting the temperature and for charging the drug applicator 900. In this example, the battery 916 is a rechargeable battery, with one battery charge The service life of the is 14 treatments, with each treatment cycle lasting approximately 5 minutes. See Figure 108 alone. The cartridge 920 also includes a nozzle 927 for dispensing liquid, and a nozzle 927 for dispensing liquid. and an orifice extending therethrough and connected to a passageway through which liquid is dispensed from cartridge 920. 923. One or more massage nodules 941 for massaging the skin of a subject. A removable massage head 940 is also provided with the medication applicator 900.

[0189] Here, the dosing and massage process is performed by the liquid dosing mechanism and 109-110, focusing on a cartridge 920 disposed within the drug applicator 900. 12. As previously described, the cartridge 920 is 00 includes a reservoir for holding the liquid, e.g., a drug, to be administered by the In this embodiment, the massage and administration actions of the drug applicator 900 are performed by the same motor 914 and motor It is actuated by a motor shaft 915 attached to a rotor 914 .

[0190] Referring to FIG. 109, an enlarged perspective view of the interaction between roller frame 911 and cam drive 921 is shown. The cam drive unit 921 is provided on the upper side for receiving the roller 911b of the roller frame 911. The upper surface has a flat or substantially flat least elevated portion and a highest elevated portion. The cartridge 920 is rotated by the motor shaft 915. During this time, the roller 911b and the roller frame 911 remain fixed. In the example, the drug applicator 900 operates without the roller frame 911 or the rollers 911b. and one or more raised or shaped features define a drug address for interaction with the cam drive 921. In fact, the cartridge is formed on the applicator 900 by molding features on the housing. If the friction between the cam surface on the roller is low enough, the molded features can eliminate the need for roller 911b. It is possible.

[0191] FIG. 112 shows a perspective view of a cam drive 921 for use with medication applicator 900. Referring briefly to FIG. 112, the cartridge 920 includes a drive key 918 at the end of the shaft 915. The drive key 918 has a receptacle 926 for receiving the cartridge 920. The cartridge 920 remains inside the receptacle 926 throughout the entire body, but is retracted depending on the position of the cartridge 920. It may move up and down inside the receptacle 926 .

[0192] Referring again to FIG. 109, since the roller frame 911 and the roller 911b are fixed, When the roller 911b is on the flat, non-highest part, the cartridge simply rotates. It should be appreciated that the cam drive 921 is a raised portion of the cam drive 921. The motor shaft 915 rotates the cartridge 920 so that it is under the roller 911b in about 10 minutes. When the cartridge is rotated, the top of the cartridge faces the cartridge actuator 923. Once the roller 911b reaches the highest position of the cam drive 921, the injection is initiated. Upon reaching the end of the cartridge 920, the cartridge 920 is in its most compressed position, resulting in a The cycle is then completed. The cartridge 920 is then rotated in the opposite direction. , cartridge 920 is decompressed as the top of the cartridge returns to its original position. The rotation angle of the cartridge 920 corresponds to the stage of the cycle or the amount of fluid or drug being administered. A moving flag or mark is sensed to determine the quantity, and such data is then controlled. The position may include three photoelectric devices, which may be either interrupters or reflectors, that transmit the light to the optical filter 912. The controller 912 may control the massage and administration operations. It communicates with the motor 914 for control.

[0193] FIG. 110 illustrates a cross-sectional view of a cartridge 920 for use with a drug applicator 900. In one example, the cartridge 920 is sold separately from the medication applicator 900. The container may be packaged individually and may be refillable with fluid or liquid. The cartridge 920 may be refilled if the cartridge 920 needs to be refilled. It may comprise a conventional prefabricated container with a piston 925 that may be placed therein. The ridges 920 act to draw liquid through them into the nozzle 927 and ultimately into the ori- An opening 92 extending through the reservoir of the cartridge 920 is dispensed through a slit 923. 4. The cartridge actuator 922 is described in more detail with reference to the aspiration operation and FIG. It interacts with cartridge 920 as will be described in detail.

[0194] FIG. 111 is a perspective view of the cartridge 920. As shown in FIG. The ridge actuator 922 is received in a slot 929 formed in the bottom of the cartridge 920. 920 includes one or more ribs 928 that are recessed into the actuator 922 and cartridge 920 together. As mentioned above, one Then, the cartridge 920 is rotated, and the roller 911b is moved beyond the raised portion of the cam drive portion 921. When it becomes high, the body of the cartridge 920 is pressed down and the cartridge actuator 921 A cartridge actuator 922 including a nozzle 927 is inserted into the drug applicator 920. The massage head 940 is fixed and attached vertically (up and down) to the The cartridge actuator 922 is fixed in position (up and down) The cartridge 920 does not move up and down inside the medication applicator 900. Rather, the top of the cartridge 920 is pushed The cartridge 920 is then lowered so that it fits inside the cartridge actuator 922. The body is pushed. This pushing action delivers the drug. When rotated in the opposite direction, the cartridge 92 The piston 92 returns to full length and the pump 924 refills the drug from the reservoir. 5 slides to reduce the storage tank volume. During operation, the entire internal storage tank It does not accept any air, therefore the cartridge 920 functions as an airless dispenser. do.

[0195] Here, the massage operation will be described with reference to Figs. 113 and 114. Fig. 113 shows the massager FIG. 114 shows a cross-sectional view of a drug applicator 900 with a drug head 940. Enlargement of the attachment between the applicator 900, the cartridge 920, and the massage head 940 FIG.

[0196] 113 and 114, a cartridge 920 and a nozzle 927 and an orifice 923 are provided. The cartridge actuator 922 is shown. The nozzle 927 is fixed to the massage head 940. The cartridge 9 including the cartridge actuator 922 is fixed and attached. As the massage head 940 rotates, the massage head 940 also rotates, creating a massaging action. The massage head 940 is attached to one or more massage heads that slide on the surface of the massage head holder 942. The massage head holder 942 is rotatably supported by a bearing having a plate 943. The attached massage head 940 and cartridge 920 are included. The massage head holder 942 is attached to the drug attachment device 92 by a collar having one or more fastening elements 945. The user inserts an empty cartridge 900 into the dispenser 900. 20 with a new filled cartridge 920. The attached parts can be removed and replaced. A cartridge locking projection 940 is also provided to receive the bottom of the cartridge actuator 922. More specifically, as best shown in FIG. The rotor 922 has a star-shaped base below the bar 928 to form gaps. Each gap is The surge head 940 is fixedly attached to the cartridge 920 so that the two rotate together. 944. Thus, the cartridge fixing projection 944 may be disposed therein. The massage head holder 942 does not rotate and is fixed to the drug applicator 900. While the cartridge 920 is attached to the massage head 940, the rotational movement of the cartridge 920 and the massage head 940 is is added consistently.

[0197] Referring to Figs. 115 and 116, the massage head is made up of two parts: a mechanical disk and It may be a rubber section, or in another example, the massage head is on a rigid disk. The elastomer may be a molded single piece. Head 940, massage nodule 941, massage head holder 942, bearing plate 943 , the cartridge locking projection 944, and the locking element 945 are provided in close-up. Any of the above-mentioned massage head shapes, types, designs, or configurations may be used as a A variety of different types of massage heads 940 may be used with the massage applicator 900. It should be recognized that it is interchangeable.

[0198] A keypad 905, a controller 912, and a position sensor 913 control the drug applicator 900. Work together to program massage and / or massage and dosing cycles It should be recognized that it is possible.

[0199] 5.2.2 Aspects of the Described Embodiments of the Applicator Device In all embodiments of the drug applicator described above, the drug applicator is Remotely transmit and receive data using external or mobile devices via oth (registered trademark) or other wireless communication. In one example, the total dose is 1 ml per treatment, divided into 5 doses of 0.2 ml each. Each pulse is delivered in a pulse length of 100 s (or an appropriate number of fewer pulses). In one example, the drug applicator is programmed to actuate the massager. A di+administration cycle may be performed for 1 minute followed by a massage only cycle for 5 minutes. A number of different programmable cycles may be selected by the user.

[0200] Many different compounds, liquids, or drugs can be dispensed using drug applicators and cartridges. and cartridges containing a variety of different compounds, liquids, or drugs may be sold separately. In addition to what is stated above in paragraphs 101 and 102, it should be recognized that: Proteasome inhibitors, such as lactacystin, peptidyl aldehydes, or pentacysteine. Many different compounds, including cyphylline (PTX), and those described in Section 5.6 below, Drugs or compounds that can be used may also be used.

[0201] For example, a water cartridge may be used for practice or a micro-needle insertion procedure may be performed. Cartridges containing therapeutic solutions may be used by the individual. Cleaning the applicator system, especially the body and viscous material cartridges A special cleaning cartridge can be provided to clean the cartridge. The cartridge contains approximately The volume may be 14 milliliters to last for more than two weeks; however, this may vary by one of skill in the art. For example, the volume of a cartridge can vary from 5 milliliters to to 20 milliliters, and the volume is at least 5 milliliters, At least 6 milliliters, at least 7 milliliters, at least 8 milliliters, At least 9 milliliters, at least 10 milliliters, at least 11 milliliters, at least At least 12 milliliters, at least 13 milliliters, at least 14 milliliters, at least At least 15 ml, at least 16 ml, at least 17 ml, at least 18ml, at least 19ml, at most 6ml, at most 7ml 10ml, at most 8ml, at most 9ml, at most 10ml, At most 11 milliliters, at most 12 milliliters, at most 13 milliliters, at most 14 Milliliters, at most 15 milliliters, at most 16 milliliters, at most 17 milliliters torr, at most 18 ml, at most 19 ml, and at most 20 ml Alternative design embodiments of the cartridge include smaller cartridges that provide a daily or unit dose. The cartridge may include, for example, a metered dose for a syringe.

[0202] In one embodiment, advantages of the applicator include, among other features: Applying chemicals while massaging and parting hair, the entire massage head Charging station, buttons that act as directional movement, light pipes and illuminated displays Power operation, remote control, and smartphone application control and monitoring without the need for a power cord It should be recognized that the main concerns with the use of minoxidil include The thing is, it is often mostly applied to the hair, not directly to the scalp. For optimal effectiveness, minoxidil must reach the surface of the skin. This is an ineffective and inefficient use of the compound. It delivers directly to the skin and the massage mode spreads the drug on the skin more consistently. The problem with minoxidil administration is that it typically This means that the drug is delivered primarily to the hair and not to the scalp. Among other things, the described drug applicator provides a more effective application of the compound to the scalp of a subject. Provide the means to use

[0203] In another embodiment, the cartridge described in any of the above embodiments comprises two or more For storing and administering drugs separately, or for mixing two or more drugs to administer the two or more drugs It should be appreciated that dual or multi-chamber cartridges may be provided for co-administration. Additionally, all of the above-described applicator embodiments may be inserted using RFID technology. The method includes the steps of: detecting an indicator provided on the inserted cartridge; For example, a drug applicator may be (a) the cartridge is provided by the same manufacturer as the drug applicator device; (b) what type of compounds are included, whether they are provided by the manufacturer or by another manufacturer; Is it in a cartridge, for example, a 5% compound of minoxidil for men or a 5% compound for women? of minoxidil 2% compound; (c) how much compound remains in the cartridge; and (d) the usage history of the cartridge, e.g., whether the cartridge has been used in a drug applicator device. Whether this is the first time the cartridge has been inserted into the The device is capable of detecting any one or more of the number of times the device is inserted into the cater device.

[0204] (5.3 Integument Disturbance) In a specific embodiment, the needle insertion device and / or needle insertion adapter is In a specific embodiment, the mobile The needle app is adapted to measure integumental perturbation in a subject. The insertion device and / or adapter may be adapted to control the extent of integumental perturbation (e.g., targeted skin perturbation (TCP)). and / or in a manner that controls the way in which integumentally perturbed skin heals. In one embodiment, integumentary perturbation involves only a superficial wound to the area of ​​skin where hair growth is desired. In certain embodiments, the extent of the wound is controlled to control the depth of integumental perturbation. For example, the disturbance of the integument can be controlled to cause disturbance of part or the whole of the epidermis, Part or all of the stratum corneum, or the deeper papillary, reticular, and / or epidermis Pinpoint bleeding can occur in the stratum corneum, epidermis (or Part of the dermis, and parts of the upper layers of the dermis, e.g., the superficial papillary dermis The occurrence of increased bleeding may indicate removal of the deeper papillary and reticular dermis. This may indicate deeper penetration (and therefore disturbance) into the formation.

[0205] In one embodiment, integument perturbation does not remove the epidermis. Integumental perturbation achieves removal of a portion of the epidermis. In some embodiments, integumental perturbation comprises: In some embodiments, integumentary perturbation removes all of the epidermis and the dermis. Removing a portion In some embodiments, integumentary perturbation removes a portion of the stratum corneum. In some embodiments, integumentary perturbation removes the stratum corneum. In some embodiments, epidermal disruption removes a portion of the papillary dermis. The perturbation removes a portion of the more superficial papillary dermis. In some embodiments, the integument perturbation removes a portion of the deeper papillary dermis. In some embodiments, integumentary perturbation comprises: In some embodiments, integumentary perturbation removes the papillary dermis. A portion of the reticular layer is removed. The depth of integumentary disruption depends on the thickness of the skin in the particular treatment area. For example, the skin of the eyelids is significantly thinner than that of the scalp. The occurrence of pinpoint bleeding may be It shows that the epidermis and part of the dermis have been removed. Deeper penetration results in more bleeding. and the disruption may extend to the depth of the subcutaneous tissue.

[0206] In certain embodiments, integumental perturbation is achieved by administering to a subject an effective amount of integument to a clinical endpoint of pinpoint bleeding. In some embodiments, the depth reaches the level of the blood vessels of the hair papilla. In some embodiments, the depth is the level of the blood vessels of the capillary loops in the papillary dermis, e.g. For example, it does not penetrate deeper than the area of ​​the papillary dermis between the interpapillary processes. In some embodiments, the integumental perturbation does not pierce the dermis. In some embodiments, most or all of the hair follicles in the area of ​​skin being treated are In one embodiment, the integumentary perturbation does not penetrate the reticular dermis. In one embodiment, integumentary perturbation does not penetrate beyond the middle of the papillary dermis.

[0207] In some embodiments, integument perturbation is performed by applying a 5-40 μm, 40-100 μm, 30-200 μm, 50- Depths of 150μm, 70~130μm, 80~120μm, 90~110μm, 95~105μm, or 100~150μm Pierce the skin with.

[0208] In some embodiments, integumentary perturbation penetrates the skin to a depth of at least 30 μm. In some embodiments, integumentary perturbation penetrates the skin to a depth of 30 μm. In some embodiments, the device penetrates the skin to a depth of 50 μm. In some embodiments, integumentary perturbation penetrates the skin to a depth of 60 μm. In some embodiments, the device penetrates the skin to a depth of 30 to 100 μm. Thus, integumental perturbation penetrates the skin to a depth of 60-100 μm. Integumentary perturbation penetrates the skin to a depth of 60-200 μm. The perturbation penetrates the skin to a depth of 100 μm. In some embodiments, the integumentary perturbation comprises: The skin is penetrated to a depth of 100-150 μm. In some embodiments, integumentary perturbation is performed at a depth of 150 In some embodiments, integumentary perturbation penetrates the skin to a depth of 100-200 μm. In some embodiments, integumentary perturbation penetrates the skin to a depth of 30-200 μm. In some embodiments, integumentary perturbation is performed at 30, 35, 40, 45, 50 , 55, 60, 65, 70, 75, 80, 85, 90, 95, 100, 105, 110, 115, 120, 125, 130, 135, 14 Skin to a depth of 0, 145, 150, 155, 160, 165, 170, 175, 180, 185, 190, 195, or 200 μm In some embodiments, the maximum depth of penetration is, for example, 30, 40, 50, 60, 70, 80, 85, 90, 95, 100, 105, 110, 120, 130, 140, 150, 160, 170, 180, 19 0, or 200 μm.

[0209] In some embodiments, integumentary perturbation penetrates the skin to a depth of 100-500 μm. In some embodiments, integumentary perturbation penetrates the skin to a depth of less than 500 μm. In some embodiments, integumentary perturbation penetrates the skin to a depth of 500-1000 μm. In some embodiments, integumentary perturbation penetrates the skin to a depth of about 1 mm. In some embodiments, integumentary perturbation penetrates the skin to a depth of about 1 mm or greater. In some embodiments, the integumentary perturbation penetrates the skin to a depth of about 2 mm. In some embodiments, the integumentary perturbation penetrates the skin to a depth of about 2 mm or more. The skin perturbation penetrates the skin to a depth of 1 mm to 3 mm. In some embodiments, the skin perturbation In certain embodiments, integumentary perturbation is performed at a depth of 500 μm. In certain embodiments, integumentary perturbation does not exceed 1 mm. In this case, the depth of skin penetration by the device does not exceed 2 mm.

[0210] In a specific embodiment, integument perturbation removes the first 10-30 μm of these dead skin cells. Remove.

[0211] In a specific embodiment, integumentary perturbation is achieved by removing the first 30-100 μm of skin. This removes part or all of the stratum corneum and epidermis. This removes the existing follicular structures, sebaceous glands, and basal It is not deep enough to remove the pores or hair papilla. Removal of the epidermis leaves the skin shiny, smooth and It can be detected by the appearance of a thin, whitish layer.

[0212] In a specific embodiment, integumentary perturbation involves the stratum corneum, all of the epidermis, and the papillary dermis (e.g., For example, the destruction of the papillary dermis is performed in the treated area. It can be detected by the appearance of tiny pinpoints of blood in the eyes.

[0213] In a specific embodiment, integumentary perturbation involves the stratum corneum, the entire epidermis, and up to about 200 μm of the dermis. Remove a portion.

[0214] In specific embodiments, integumental perturbation is performed using the methods of use described in Section 5.4. It is held in.

[0215] (5.4 Method of Use) The devices described herein may comprise one, two or more of the components described in Section 5.4.5(a). Without wishing to be bound by theory, The device described herein is capable of inducing hair follicle neogenesis and promoting hair growth. It can also stimulate, activate and reorganize the follicular structure to promote hair growth. Many conventional pharmacological treatments (e.g., the drugs described in Section 5.6 below) In a specific embodiment, the method described herein promotes the conversion of hair from terminal hair to terminal hair. The device stimulates and activates the hair follicles, which are correlated with increased hair growth, if not terminal hair. It is suitable for promoting the formation of stimulated and reorganized hair follicle structure. By increasing the number of hair follicles and vellus or terminal hairs, the devices described herein The device may be suitable to provide additional substrates for the action of these pharmacological treatments. Thus, in some embodiments, the devices described herein are capable of increasing hair growth, Suitable for increasing hair thickness and / or producing longer lasting hair Such treatments are therefore more effective, efficient, and cost-effective than pharmacological treatments alone. and can be user friendly, e.g., fewer treatments are required. The resulting hair will be more cosmetically pleasing, longer lasting, thicker, more evenly distributed, and For example, in one embodiment, the hair may be uniform, longer, and properly pigmented. The needle insertion devices and / or needle insertion adapters described herein are useful in conjunction with the administration of pharmacological treatments. When used in combination, the biological outcomes described in Section 5.4.5(a) In one or more of the studies, the efficacy and safety of the drug was 1.25-fold, 1.5-fold, 2-fold, 2.5-fold, 3-fold, or 3-fold higher than that of pharmacological treatment alone. Suitable for producing a .5-fold or 4-fold or greater increase. In one embodiment, the methods of treatment described herein involve integumental perturbation (e.g., (with the needle insertion device and / or adapter described in the document) and administration of pharmacological treatments (e.g. (e.g., drugs described in Section 5.6 below) and described in Section 5.4.5(a). Pharmacological treatment alone (i.e., integument perturbation therapy) was shown to be effective in one or more of the biological outcomes listed below. 1.25, 1.5, 2, 2.5, 3, 3.5, or 4 times the effectiveness of treatment with In a specific embodiment, the needle insertion method described herein produces a greater increase. The needle insertion device and / or needle insertion adapter may be used in conjunction with the administration of pharmacological treatment. , one or more of the biological outcomes described in Section 5.4.5(a) are measured by a controlled method. At least 5%, 10%, 20%, 30%, or more of the time required to achieve said one or more biological outcomes. %, 40%, 50%, 60%, 70%, 80%, 90%, or 98%. In certain embodiments, the needle insertion devices and / or needle insertion adapters described herein include When used in combination with pharmacological treatment, the and determining whether a control method achieves one or more of the biological outcomes of the subject. At most 5%, 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 9% of the time required 0%, or 98%. In a specific embodiment, the control method is , microdermabrasion and medications (e.g., those described in Section 5.6 below). In a specific embodiment, the control method comprises the administration of a pharmacological treatment. The method of treatment alone (i.e., without the step of perturbing the integument) is The synergistic effect of perturbation and drug administration was evaluated in comparison with control subjects who received the drug but did not undergo integument perturbation. (or a control skin site in the same subject).

[0216] (5.4.1 How to use the needle insertion device) In one example, a method of using a needle insertion device includes a sheath assembly including a needle array; A needle insertion device is provided having a main unit with a motor for driving the needle array. and opening the sheath assembly to completely encase the main unit and protect it from the outside environment. disposing said main unit within said sheath assembly such that said needle insertion device is inserted into said sheath assembly; and The method includes removing the sheath assembly and and replacing the sheath assembly with another sheath assembly having a different needle array. That's fine.

[0217] For example, a needle array having a rectangular arrangement may be used by a physician on a patient for hair growth applications. After use, the first adapter may be attached to a different sheath adapter. The needle array may be replaced with a second sheath adapter having a needle array arrangement, e.g., a circular needle array arrangement. The needle insertion device can be inserted into different areas of the skin of one patient without the need to clean the needle insertion device. This is because the needle insertion device is completely enclosed within the adapter sheath. The needle insertion device may also be used on different patients. For example, the physician may: A first needle insertion adapter may be used with the device on a first patient, followed by a second needle insertion adapter. Removing the first adapter and replacing it with the second needle insertion adapter for use with the patient. As mentioned above, with reference to the description of the needle insertion device, several different techniques, e.g. , performing procedures for hair growth applications, wrinkle removal, scar removal, hair removal, tattoo removal, and pigmentation possible.

[0218] In a specific embodiment, the needle insertion device is The method is used in

[0219] (5.4.2 How to use the applicator device) In one example, a method of using an applicator device includes providing a housing, a drug delivery cartridge held by the housing, and a massager mounted on the housing. providing an applicator having a head; powering the applicator; and by a dosing mechanism coupled to the movement of the massage head, or by any other dosing mechanism. In one example, the applicator device includes a mechanism for automatically administering the medication. Pre-set massages programmed by a doctor or any user or follow a cycle of massage and administration; for example, a 5-minute massage cycle with 1 A minute massage and dosage cycle follows. The device can be controlled from the keypad on the device or It may also be programmed wirelessly using an external device.

[0220] The method further comprises removing the massage head and attached drug delivery cartridge. and transferring said massage head and attached drug delivery cartridge to a device for administering a different drug Another massage head with a delivery cartridge and a different nodule arrangement The method may further include replacing the remote user interface with a remote massage head. and receiving notifications from the applicator using an interface. It may further include interacting.

[0221] In a specific embodiment, the applicator device is an applicator device as described in Section 5.4.5. The present invention is used in a method of treatment comprising administering to a subject a

[0222] 5.4.3 How to Use the Needle Insertion Device and the Applicator Device Together The method of using a needle insertion device and a drug applicator together to stimulate hair growth includes a sheath assembly having an array; and a main unit having a motor for driving the needle array. a housing; a needle insertion device having a housing; a drug delivery cartridge mounted on said housing for massaging the skin of a subject; Drug application device for drug delivery and massage with attached massage head - Patents.com and providing a needle insertion device for inserting a targeted skin layer for disrupting a layer of human scalp. and after using the needle insertion device, delivering a drug to the disrupted layer of the human scalp. using the drug applicator to apply the drug.

[0223] The method further includes disrupting a layer of the human scalp that is the basal or suprabasal layer of the epidermis. The drugs used are minoxidil, lactacystin, peptide proteasome inhibitors, such as dialdehyde or pentoxifylline (PTX), or Compounds described in Section 5.6.

[0224] In a specific embodiment, the needle insertion device and the applicator device are The compounds are used in the methods of treatment described in.

[0225] 5.4.4 Mobile Apps in Combination with Needle Insertion Devices and / or Applicator Devices and Use (Method) A mobile app is used to control and provide feedback to the physician or user. and may be used in combination with a respective needle insertion device or fluid applicator. For example, the user may adjust the needle depth, needle insertion speed, and other parameters applicable to the devices described in this application. Needle insertion cycle length, applicator massage speed, massage cycle length, This includes the amount of fluid administered, the rate of administration, and other aspects of needle insertion, massage, and administration actions. The app may control all aspects of the needle insertion device and applicator device. The needle insertion device allows the user to customize the needle insertion, massage, and administration procedure. Controlled by pre-defined parameters, pre-defined parameters This is followed by one cycle of massage with the aid of a stimulating massage, and according to preset parameters. This may be followed by a cycle of administering fluid according to the method of the present invention.

[0226] A mobile app may be used to provide notifications to the physician or user. Some other programmable parameters of each needle insertion device and applicator device along with whether the procedure has not been performed for a period of time, and whether it is time for the next procedure. How much fluid is flowing, if the fluid cartridge needs replacing, the current needle depth in the needle array, the needle array placement, The shape may be notified to the user.

[0227] In a specific embodiment, the needle insertion device, the applicator device, and / or the mobile app is used in the treatment method described in Section 5.4.5.

[0228] (5.4.5 Methods of prophylactic and therapeutic use) The devices and / or mobile apps described herein are suitable for achieving one or more of the biological outcomes described in Section 5.4.5(a). Accordingly, provided herein is a method of treatment comprising the use of (i) the needle insertion device and / or needle insertion adapter described herein; and / or (ii) the applicator device described herein, on a region of skin of a subject in need thereof, wherein the method of treatment achieves one or more of the biological outcomes described in Section 5.4.5(a) in the subject. In a specific embodiment, the method further comprises the use of the mobile app described herein.

[0229] In a specific embodiment, provided herein is a method of treatment comprising (a) an epidermal perturbation of a region of skin of a subject in need thereof, wherein the epidermal perturbation is effected by the needle insertion device and / or adapter described herein; and (b) administering to the subject, after a first period, a pharmaceutically effective dose of a drug or a formulation thereof described in Section 5.6 as a first pharmaceutical, wherein the method of treatment achieves one or more of the biological outcomes described in Section 5.4.5(a). In a specific embodiment, the method further In a specific embodiment, step (c) of the method further comprises administering the formulation. ) may be repeated 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 or more times or This process is repeated until the outcomes described in step 5.4.5(a) are achieved. In embodiments, integument perturbation is similar to that described in Section 5.3.

[0230] In a specific embodiment, provided herein is a method for treating a pulmonary syndrome (PSS) syndrome. Administer the drugs or preparations described in Section 5.6 in effective doses to patients who need them. to an area of ​​the skin of a subject having integumental perturbation, In a specific embodiment, the medicament or formulation thereof is wherein the first period is from 10 days after the skin is integumentally perturbed, In a specific embodiment, the method further comprises: (c) administering to the subject a second period of time after the second period of time. The method further comprises administering to the patient a medicament effective amount of a second agent or formulation thereof. In one embodiment, step (c) of the method comprises 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 or more or the outcome described in Section 5.4.5(a) is achieved. In particular embodiments, integument perturbation is performed using the method described in Section 5.3. It is similar to what is listed.

[0231] In a specific embodiment, the methods of treatment provided herein comprise the steps of: In a specific embodiment, the mobile app further includes a The protocol determines one or more of the biological outcomes described in Section 5.4.5(a). It is suitable for.

[0232] In a specific embodiment, the area of ​​skin is an area of ​​the subject where hair growth is desired, e.g., the scalp. , face (e.g., eyebrows, eyelashes, upper lip, lower lip, chin, cheeks, beard area, or mustache area), or another Parts of the body, such as the chest, abdomen, arms, armpits (area of ​​armpit hair), legs, or genitals. In a specific embodiment, the area of ​​skin is the head. In some embodiments, the area of ​​skin is the scalp. In some embodiments, the area of ​​skin is a balding area. In a specific embodiment, the area of ​​skin is not on the face. In an embodiment, the area of ​​skin is skin that is normally covered only with downy hair or mostly with downy hair. In a specific embodiment, hair growth is desired in areas of a skin wound or scar. and / or scarring is desired. Thus, in a specific embodiment, the area of ​​skin is , wounds or scars on the skin. In a specific embodiment, the scar is caused by surgery, e.g. , caused by a face lift, skin graft, or hair transplant.

[0233] In another embodiment, tattoo removal is desired. The area of ​​skin is the area of ​​skin that is tattooed.

[0234] In another embodiment, a reduction in the visibility of wrinkles is desired. In the present invention, the area of ​​skin is a wrinkled area of ​​skin.

[0235] In another embodiment, a change in skin pigmentation is desired. In the method, the area of ​​skin exhibits altered pigmentation compared to the majority of the subject's skin pigmentation. It is an area of ​​the skin.

[0236] In a specific embodiment, the area of ​​skin may be any desired size, e.g., 0-3 mm in width. mm (e.g., 1 mm, 2 mm, 3 mm, or larger), width 0-2 cm (e.g., 1 cm, 1.5 cm, and 2.0 cm), or larger (e.g., up to 10%, 30%, 50%, 70% of the subject's skin %, 90%, or 100%) of the area of ​​skin. Optionally, the area of ​​skin is interfollicular.

[0237] In a specific embodiment, the first period of time is 1 minute, 2 minutes, 3 minutes, 4 minutes, 5 minutes, 10 minutes, 15 minutes, 20 minutes, minutes, 25 minutes, 30 minutes, 45 minutes, 60 minutes, 3 hours, 6 hours, 12 hours, 24 hours, 2 days, 3 days, 4 days, 5 days, 6 days, 7 days, 8 days, 9 days, 10 days, 11 days, 12 days, 13 days, 14 days, 3 weeks, or less than 4 weeks. In certain embodiments, the first period of time between is at least 1 minute, 2 minutes, 3 minutes, 4 minutes, 5 minutes, 10 minutes, , 15 min, 20 min, 25 min, 30 min, 45 min, 60 min, 3 hr, 6 hr, 12 hr, 24 hr, 2 days, 3 days, 4 1, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 3 weeks, or 4 weeks. In a specific embodiment, the first period of time between is at most 1 minute, 2 minutes, 3 minutes, 4 minutes, 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes, 45 minutes, 60 minutes, 3 hours, 6 hours, 12 hours, 24 hours, 2 days, 3 days , 4th, 5th, 6th, 7th, 8th, 9th, 10th, 11th, 12th, 13th, 14th, 3 weeks, or 4 weeks be.

[0238] In a specific embodiment, the agent is delivered by an applicator device described herein. and administered to the subject.

[0239] In a specific embodiment, the agent is administered to an area of ​​the subject's skin where a needle insertion device is used. will be done.

[0240] In a specific embodiment, the second period of time is 1 minute, 2 minutes, 3 minutes, 4 minutes, 5 minutes, 10 minutes, 15 minutes, 20 minutes, minutes, 25 minutes, 30 minutes, 45 minutes, 60 minutes, 3 hours, 6 hours, 12 hours, 24 hours, 2 days, 3 days, 4 days, 5 days, 6 days, 7 days, 8 days, 9 days, 10 days, 11 days, 12 days, 13 days, 14 days, 3 weeks, or less than 4 weeks. In certain embodiments, the second period of time is at least 1 minute, 2 minutes, 3 minutes, 4 minutes, 5 minutes, 10 minutes, 15 minutes, or more. minutes, 20 minutes, 25 minutes, 30 minutes, 45 minutes, 60 minutes, 3 hours, 6 hours, 12 hours, 24 hours, 2 days, 3 days, 4 days, 5 1, 6, 7, 8, 9, 10, 11, 12, 13, 14 days, 3 weeks, or 4 weeks. In an exemplary embodiment, the second period of time is at most 1 minute, 2 minutes, 3 minutes, 4 minutes, 5 minutes, 10 minutes, 15 minutes, , 20 minutes, 25 minutes, 30 minutes, 45 minutes, 60 minutes, 3 hours, 6 hours, 12 hours, 24 hours, 2 days, 3 days, 4 days, 5 days , 6th, 7th, 8th, 9th, 10th, 11th, 12th, 13th, 14th, 3 weeks, or 4 weeks.

[0241] In specific embodiments, the first pharma- ceutically effective dose of the agent is as described in Section 5.7. In a specific embodiment, the second medicament effective dose of the agent is Doses are those described in Section 5.7.

[0242] In some embodiments, integumental perturbation induces wounds in the skin. In some embodiments, the integumentally perturbed skin is wounded. In some embodiments, the wounded skin heals by primary healing. In yet another embodiment, the wounded skin heals by secondary healing. In one embodiment, the wounded skin heals by tertiary healing. The scar heals more slowly than is usually observed for that type of wound. May enhance scarless wound healing and / or promote hair growth in wounded areas of skin In a specific embodiment, the method includes administering a post-perturbation wound healing compound to the subject. The method further includes administering the product.

[0243] In specific embodiments, the subject is a subject described in Section 5.5.

[0244] In a specific embodiment, the methods of treatment include those of the subject described in Section 5.5. A method of treating a condition or disorder.

[0245] For any of the above-mentioned treatments, in specific embodiments, a particular treatment (e.g. For example, integument perturbation) may be combined with administration of a second (or third or subsequent) treatment (for example, a first or second medication). The method may be performed prior to, concurrently with, or subsequent to administration of a therapeutically effective dose of a drug. In certain embodiments, the second or third or subsequent treatments are different (e.g., In an embodiment, it includes treatment with the same active agent, but at a higher (or higher) dose.

[0246] In one embodiment, one treatment is administered to a subject at reasonably the same time as another treatment. The method may be performed in a time frame in which the two runs are separated from each other by less than 1 minute to about 5 minutes, or by up to about 60 minutes. In another embodiment, the method includes: The one treatment and the other treatment are performed at exactly the same time.

[0247] In yet another embodiment, the one treatment and the other treatment are administered in sequence and the one treatment and the other treatment are administered in sequence. Other treatments may work together to provide increased benefit than if they were administered alone. In another embodiment, said one treatment and and other treatments are administered sufficiently close in time to provide the desired outcome. They may be administered simultaneously or separately, in any suitable form, and by any suitable route. In one embodiment, the one treatment and the other treatment are administered by different routes of administration. In alternative embodiments, each is performed by the same route of administration. In one embodiment, the one treatment and the other treatment are administered to the same or different sites on the subject's body. When administered simultaneously, the one treatment and the other treatment may be administered in a single formulation. the same agent, a mixture of formulations, or at the same site of administration or by the same route of administration. It does not have to be done either.

[0248] In various embodiments, the one treatment and the other treatment are administered less than an hour apart and about an hour apart. Leave between 1 and 2 hours, leave between 2 and 3 hours, leave between 3 and 4 hours, leave between 4 and 5 hours Leave between 5 and 6 hours, leave between 6 and 7 hours, leave between 7 and 8 hours, leave between 8 and 9 hours Leave between 9 and 10 hours, leave between 10 and 11 hours, leave between 11 and 12 hours, 24 hours In another embodiment, the two treatments are administered no more than 10 minutes apart or no more than 48 hours apart. And other treatments are given 2-4 days apart, 4-6 days apart, 1 week apart, 1-2 weeks apart, and 2-4 weeks apart. Leave a gap, leave a month, leave a gap of 1-2 months, leave a gap of 2-3 months, leave a gap of 3-4 months, leave a gap of 4-5 months The tests are conducted after a 6-month interval, after a 6-month interval to a year interval, or after an interval of more than a year. In embodiments, the one treatment and the other treatment are administered within a time frame during which both are still active. One of ordinary skill in the art can easily determine this by determining the half-life of each of the administered components. Such a time frame could be determined by

[0249] In one embodiment, the one treatment and the other treatment are administered during the same patient visit. In one embodiment, the one treatment is administered prior to administration of the other treatment. In an embodiment, said one treatment is administered subsequent to administration of said other treatment.

[0250] In certain embodiments, the one treatment and the other treatment are cyclically administered to the subject. Periodic treatment consists of the administration of one or more treatments at one time or over a period of time, followed by one or more The first treatment involves administering the other treatment for a period of time, and repeating this successive administration. The treatment may be administered either in conjunction with the first treatment or in combination with the second treatment, depending on the subject's prior treatment history and the intended outcome. Such cyclical therapy may be combined with other treatments. Such cyclical therapy has the advantages described herein. In addition, cycling therapy may reduce the development of resistance to one or more of the treatments. , avoiding or reducing the side effects of one of the treatments and / or improving the efficacy of the treatment. In such an embodiment, after one year of alternating administration of one or more treatments, , 6 months, 3 months, 1 month, 3 weeks, 2 weeks, 1 week, 4-6 days, 2-4 days, or This may be followed one or two days later by administration of another treatment (or vice versa), where such Such a cycle may be repeated as many times as desired. In one embodiment, the one (or more) The above other treatments should be administered once every 2 weeks, once every 10 days, in cycles of 3 weeks or less. Such time frames may vary depending on the nature of the treatment, e.g. For example, depending on whether a controlled release formulation is used and / or as the course of treatment progresses. The period may be extended or shortened accordingly.

[0251] In a specific embodiment, the applicator device described herein is adapted to deliver a chemical to a subject. Thus, what is provided herein is suitable for administration of the compounds described herein. and administering the compound to a subject in need thereof, including using an applicator device as described herein. In a specific embodiment, the compound is a compound as described in Section 5.6. It is a compound.

[0252] (a) Biological outcome In specific embodiments, the needle insertion devices, needle insertion adapters, and The applicator device and / or mobile app may be used to measure the biological outcomes described herein. In a specific embodiment, the method is suitable for achieving one or more of the above-mentioned The needle insertion device is adapted to achieve one or more of the biological outcomes described herein. In a specific embodiment, the needle insertion adapter described herein is suitable for: Suitable for achieving one or more of the biological outcomes described herein. In certain embodiments, the applicator device described herein is In a specific embodiment, the present invention is adapted to achieve one or more of the following biological outcomes: The mobile app described herein may be used to assess the biological outcomes described herein. Accordingly, the devices and / or methods described herein are suitable for achieving one or more of the following: Methods of treatment that include the use of one or more of the mobile apps described herein are provided herein. Achieving one or more of the described biological outcomes.

[0253] In specific embodiments, the devices and / or mobile apps described herein: Non-limiting biological outcomes in subjects in whom the device and / or mobile app was used include: Typical examples: hair growth applications, wrinkle removal, scar formation, hair removal, tattoo removal, and pigmentation control. Non-limiting examples of hair growth applications include increasing hair volume and Increase hair thickness, increase hair lifespan, promote hair follicle regeneration Inducing, Treating Baldness, Treating Alopecia, Removing Hair on an Area of ​​the Skin of a Subject Promoting follicle development and / or activation, and / or the conditions described in Section 5.5. Examples of treatment include:

[0254] In specific embodiments, the devices and / or mobile apps described herein: Non-limiting biological outcomes in subjects in whom the device and / or mobile app was used include: Typical examples: promoting the development of new hair follicles ("neogenization"); Promoting the formation of c-like (NL) follicular structures (possibly by remodeling) Promoting the activation of existing hair follicles; pre-existing-like (PEL) or pre-existing-like attachment ( PELA; pre-existing-like, attached) promotes the formation of hair follicle structures; promotes hair follicle development For example, to promote the growth of terminal hair (in preference to vellus hair); to promote the growth of existing hair follicles promotes hair follicle saturation (seen as an increased number of hair shafts per follicle); increases the width of the hair follicle (thereby promoting the growth of increased hair shaft width); slowing or preventing aging of the hair follicle ; to accomplish one or more of the following:

[0255] In specific embodiments, the devices and / or mobile apps described herein: Non-limiting biological outcomes in subjects in whom the device and / or mobile app was used include: Typical examples: promoting hair growth; promoting the growth of vellus hair; transferring vellus hair to terminal hair Increase the amount of hair follicles in the growth phase, prolong the growth phase, and promote hair growth. Shortening the anagen phase; promoting the growth of terminal hair; increasing the amount of hair; hair thickness and / or reducing or preventing hair loss. It is suitable for making

[0256] In specific embodiments, the devices and / or mobile apps described herein: Non-limiting biological outcomes in subjects in whom the device and / or mobile app was used include: Typical examples: promoting hair growth in the follicular unit; promoting the growth of vellus hair in the follicular unit and promoting the transition of vellus hair in the follicular unit to terminal hair in the follicular unit. ; Promoting the growth of terminal hair in the follicular unit; Increasing the amount of hair in the follicular unit and / or increasing the thickness of hair in the follicular unit; and / or preventing hair loss in the follicular unit. or reducing or preventing hair thinning. There are.

[0257] In one embodiment, the biological outcome is hair growth on an area of ​​the subject's skin. In some embodiments, the biological outcome is the amount or amount of hair on the treated area of ​​skin of the subject. In some embodiments, the biological outcome is an increase in the thickness of the treated subject. In some embodiments, the biological outcome is an increase in the amount of vellus hair on an area of ​​skin. or an increase in the amount of terminal hair on the treated area of ​​skin of the subject. The biological outcome is the maintenance of terminal hair growth, i.e., helping to prevent miniaturization of terminal hair. In some embodiments, the biological outcome is the appearance of a cyst on the treated area of ​​skin in the subject. In some embodiments, the biological outcome is an increase in the ratio of terminal hair to terminal hair. Increased long-term hair volume or anagen growth on the treated skin area of ​​the subject In some embodiments, the biological outcome is a decrease in the amount of erythrocytes in the treated area of ​​skin of the subject. In some embodiments, the ratio of anagen to telogen hairs in the biological The clinical outcome is hair follicle neogenesis in the treated area of ​​skin of the subject. In the present study, the biological outcome is an increased number of hair follicles in the treated area of ​​skin of the subject. In some embodiments, the biological outcome is a decrease in the area of ​​treated skin of the subject. have a non-vellus-sized hair shaft (i.e., a hair shaft having a diameter of 30 microns or more) In some embodiments, the biological outcome is the formation of new hair follicles. Stimulated and activated hair follicles in the area of ​​skin to be treated, e.g., increased number of existing hair follicles. In some embodiments, the biological outcome is a number of times that the area of ​​treated skin of the subject is The increased number of existing hair follicles with non-vellus sized hair shafts in the In an embodiment, the biological outcome is determined by the presence or absence of neonatal-like (NL) follicular structures, pre-existing-like (PEL), and pre-existing-like attached (PE). LA) the presence and / or increased number of follicular structures.

[0258] The success of the device in achieving one or more of the biological outcomes described herein and / or The success of the methods of the invention may be measured, for example, by: (i) improved overall cosmetic outcomes (e.g., visual acuity, (ii) the patient's own assessment of hair growth (e.g., based on a questionnaire); (iii) Investigator assessment of hair growth in patients (e.g., based on a rating scale); (iv) Patient's own assessment of hair growth in photographs; (v) Investigator's assessment of hair growth in photographs of patients (vi) increased hair count (e.g., increased fiber count in affected areas of skin); (vii) increased hair density; (viii) hair or (ix) increased hair shaft thickness (e.g., based on diameter); (x) increased hair weight; (xi) hair shedding; (xii) an increase in the amount of terminal hair (e.g., increased fiber in the affected skin area); Measure new hair growth as the number of fibers or the increased thickness (e.g., diameter, or length of hair fibers) (xiii) an increase in the amount of vellus hair (e.g., increased hair volume in the affected skin area); by measuring new hair growth as the number of added fibers (e.g., measured photographically); (xiv) an increase in the amount of non-vellus hair, e.g., intermediate or terminal hair; (xv) an increase in the ratio of terminal hair to vellus hair. (xvi) increased hair germ number; (xvii) increased hair follicle number (e.g., as assessed by skin biopsy) (xviii) an increased number of hair follicles at a more mature stage of development; (xix) an increased number of three or more (xx) the number of follicular units containing hair follicles; (xxi) increased hair follicle branching; (xxi) the formation of new hair follicles ("hair follicle (xxii) hair shafts of vellus size (i.e., hair shafts having a diameter of less than 30 microns) (xxiii) formation of new hair follicles having non-vellus sized hair shafts (i.e., hair shafts with a diameter of 30 microns); (xxiv) hair follicle regeneration; (xxv) the formation of new hair follicles having hair shafts with diameters equal to or greater than 1 mm; (xxvi) increased activation of hair follicles; (xxvii) increased number of activated hair follicles; (xxvii) increased number of activated hair follicles; xviii) increased number of activated pre-existing hair follicles; (xxix) the presence or increased number of neoplastic-like (NL) hair follicles number (e.g., by assessing the number of hair follicles, either based on biopsy review or by confocal microscopy) and / or by assessing hair follicle morphology compared to baseline or negative controls. (xxx) the presence or increased number of existing hair follicles (e.g., based on biopsy review or confocal imaging); Microscopically, by assessing the number of hair follicles, and / or as a baseline or negative control. (xxxi) assessing hair follicle morphology by comparing; (xxxi) determining whether a primordial structure of interest (SOI), e.g., neoformation-like ( The presence or increased number of preexisting-like (NL), preexisting-like (PEL), and / or preexisting-like attached (PELA) follicular structures (e.g., Based on examination of a biopsy or confocal microscopy, assessment of the number of hair follicles, and / or, for example, Assessment of hair follicle morphology compared to baseline or negative control as described in Section 5.8.4. (xxxii) a previously treated skin layer having hair shafts the size of downy hair in the area of ​​the skin to be treated of the subject; (xxxiii) an increased number of existing hair follicles; (xxxiii) an increased number of downy-sized hairs in the treated skin area of ​​the subject. (xxxiv) an increased number of anagen-like hair follicles with shafts; (xxxv) an increased amount of telogen hairs; (xxxvi) an increased proportion of hair follicles in the anagen phase or a decreased proportion of hair follicles in the telogen phase (i.e., an increase in the ratio of anagen to telogen hairs) (e.g., after biopsy or (xxxvii) increased proliferation of the dermal papillae (e.g., on biopsy review) and / or (xxxviii) increased recruitment or proliferation of stem cells to hair follicles (e.g., based on biopsy findings). This can be measured by a variety of methods (based on surveys).

[0259] In some embodiments, the devices described herein are used to achieve uniform integumentary disruption. For example, in certain embodiments, the devices described herein are suitable for integumental perturbation. It is suitable to achieve uniformity of perforation. In a specific embodiment, the uniformity is 1 / 2 It is measured by the variance of perforations per centimeter. Uniformity is at least + / -1%, at least + / -3%, at least + / -5%, at least + / -10% , at least + / -15%, at least + / -20%, at least + / -30%, at least + / -50% In specific embodiments, the uniformity is at most + / - 1%, at most + / - 3%, at most + / - 4%, at most + / - 5%, at most + / - 6%, at most + / - 7%, at most + / - 8%, at most + / - 9%, at most + / - 10%, at most + / - 11%, at most + / - 12%, at most + / - 13%, at most + / - 14%, at most + / - 15%, at + / -5%, at most + / -10%, at most + / -15%, at most + / -20%, at most + / -30%, at most at most + / -50%, at most + / -60%, at most + / -70%, at most + / -80%, or at most 90% It is.

[0260] In one embodiment, the success of the treatment can be determined by examining hair follicles in the treated area of ​​the subject's skin. In some embodiments, hair follicles are assessed histologically or by the analysis of hair follicle development or The skin is examined by determining the presence or absence of certain markers of morphology. The area may be obtained by biopsy, e.g., punch biopsy; alternatively, or in addition, In order to achieve this, the skin can be examined in a less invasive manner, for example by confocal microscopy or by imaging beneath the surface of the skin. It may also be directly analyzed by other techniques that allow imaging.

[0261] 5.5 Subject Populations that may be treated with the Needle Insertion and / or Applicator Devices The devices and / or mobile apps described herein are directed to the subject matter described herein. Thus, what is described herein is suitable for use in In a specific embodiment, the subject is a candidate for treatment with the device and / or one or more methods. The elephant is suffering from or has a disease or condition related to hair loss, hair thinning, or baldness Do you have or have had hair loss or would like to enhance hair growth or thickness? or any subject wishing to prevent hair loss. In a specific embodiment, the subject , have a tattoo and wish to remove or reduce the visibility of the tattoo. In a specific embodiment, the subject has wrinkles and desires to remove said wrinkles or In a specific embodiment, the subject wishes to reduce the visibility of the scar. have scars and would like to remove or reduce the visibility of the scars. In one embodiment, the subject is administered a cutaneous test to determine whether an area of ​​altered skin has been detected in the subject, as compared to a control area of ​​the subject's skin. have pigmentation and wish to remove or reduce the visibility of the altered pigmentation I hope to do so.

[0262] The subject may be any subject, preferably a male subject, a female subject, a subject of neutral / ambiguous gender (e.g. For example, the subject may be a human subject, including a transgender (XO) subject, and a transgender subject. In some embodiments, the subject is a human adolescent. In some embodiments, the subject is in adolescence. In some embodiments, the subject is a middle-aged adult. In some embodiments, the subject is in menopause. In some embodiments, the subject is aged 1 year or less, 2 years or less, 2 years, 5 years, 5 to 1 year, 0 years old, 10-15 years old, for example, 12 years old, 15-20 years old, 20-25 years old, 25-30 years old, 30 years old or older, 30-35 years old, 3 5 years old and over, 35-40 years old, 40 years old and over, 40-45 years old, 45-50 years old, 50 years old and over, 50-55 years old, 55-60 years old, 6 0 years old and over, 60-65 years old, for example, 65 years old, 65-70 years old, 70-75 years old, 75-80 years old, 80-85 years old, 85-90 years old In some embodiments, the subject is a human aged 20 to 95 years, or 95 years or older. In some embodiments, the subject is a male between the ages of 20 and 60. In some embodiments, the subject is a male between the ages of 30 and 60. In some embodiments, the subject is a male between 40 and 60 years of age. In some embodiments, the subject is a male between 12 and 40 years of age. In some embodiments, the subject is not a female subject. In some embodiments, the subject is not pregnant and does not wish to become pregnant. In some embodiments, the subject is not a pregnant woman in the first trimester of pregnancy. In some embodiments, the subject is not lactating.

[0263] The subject is diagnosed with a disease or disorder of baldness or hair loss (including hair thinning), e.g., nonscarring cicatricial (non-cicatricial) alopecia, such as male pattern baldness (MPHL) or female pattern baldness ( Androgenetic alopecia (AGA) including FPHL (e.g., thinning of hair, i.e., frontal / vertex Hair loss may be in the form of diffuse alopecia on the scalp, or in the form of androgen-induced alopecia. Other forms of alopecia include toxic alopecia, alopecia areata (including alopecia universalis), scarring (scarring Cicatricial alopecia, pathological alopecia (e.g., due to medication, traumatic stress, self- caused by immune disorders, malnutrition, or endocrine dysfunction), trichotillomania, hypotrichosis A form of lichen planus, such as congenital hypotrichosis or lichen planus pilaris, or a form of lichen planus known in the art. The patient may be known to have hair loss or baldness or may have any of the other conditions of hair loss or baldness described below.

[0264] In some embodiments, the subject is diagnosed with a genetic or hereditary disease or disorder, e.g., Have hair loss caused by androgenetic alopecia.

[0265] In some embodiments, the subject is treated with anagen detachment, e.g., chemotherapy (e.g., 5-fluorouracil, between fluorouracil, methotrexate, cyclophosphamide, and vincristine In addition to chemotherapy drugs, anagen detachment is caused by , other toxins, radiation exposure (including radiation overdose), endocrine disorders, trauma, pressure, and It is caused by certain diseases, such as alopecia areata (an autoimmune disease that attacks anagen hair follicles). It can be done.

[0266] In some embodiments, the subject has hair loss caused by telogen effluvium. Telogen detachment can be induced by drugs such as lithium and other drugs such as valproate and carbamazepine. In addition to psychiatric drugs, telogen effluvium can also be caused by childbirth, It may be induced by traction, febrile illness, surgery, stress, or nutritional deficiencies. (Merck (See, e.g., 2000, Ann. Clin. Psych. 12:35-42).

[0267] In some embodiments, the subject is receiving medical therapy, e.g., chemotherapy (e.g., anti-cancer therapeutic or cytotoxic drugs), thallium compounds, vitamins (e.g., vitamin A), retinoic acid Antiviral therapy, antiviral therapy, or psychological therapy, radiation (e.g., radiation overdose) (scalp hair loss stripes that can be caused by trauma, endocrine dysfunction, surgery, physical trauma, radiographic atrophy, burns or other injuries or wounds, stress, aging, autoimmune diseases or disability, malnutrition, infection (including, for example, chronic deep bacterial or fungal infections) fungal, viral or bacterial infections), dermatitis, psoriasis, eczema, pregnancy, allergies dyspnea, serious illnesses (e.g. scarlet fever), myxedema, hypopituitarism, early syphilis, discoid edema erythematosus, cutaneous lupus erythematosus, lichen planus, deep dividing ulcers, granulomas (e.g. Sarcoidosis, syphilitic gumma, TB), inflammatory tinea capitis (kerion, jaundice), slow growth of the scalp The present invention relates to a method for treating cutaneous tumors, such as cutaneous tumors or other skin tumors, or tumors known in the art or described below. Caused by any other disease or disorder associated with or causing baldness or hair loss There is rubbing or associated hair loss.

[0268] In some embodiments, the subject is receiving tissue or hair transplant for hair transplant or follicular unit transplant. is hair thinning caused by previous use as a source of hair follicles, or "shock Loss, or bald areas.

[0269] In some embodiments, the candidate subject desires to enhance hair growth, e.g., to grow more hair. Those who wish to have longer, thicker hair, faster growing hair, and / or longer hair. In some embodiments, the candidate desires to increase hair pigmentation. In some embodiments, the subject is not affected by an excessive hair loss condition. .

[0270] As used herein, the terms "patient" and "subject" are used interchangeably.

[0271] (5.6 Drugs) As used herein, the present invention may be administered by the devices provided herein. may be used in combination with the devices described herein and / or in the manner described herein. Also provided are agents that may be used in the methods. In particular embodiments, the agents are In a specific embodiment, the pharmaceutical composition is formulated with the drug and the medicament. Pharmaceutically acceptable carriers and excipients include those known in the art. It is well known in the art.

[0272] In one embodiment, the agent is an agent that promotes hair growth. For example, according to this embodiment, Hair growth promoters for use, or in combination, include: those that affect prostaglandins Drugs such as prostaglandin F2α analogues, such as latanoprost (trade name Xalatan ), travoprost (brand name Travatan), tafluprost, unoprostone, dinoprost ( Product name Prostin F2 Alpha), AS604872, BOL303259X, PF3187207, Carboprost (Product Hemabate; prostamides, such as bimatoprost (Latisse, Lumigan); Tanoid receptor agonists, e.g., fluprostenol; prostaglandin D2 receptor agonists antagonists, e.g., laropiprant, AM211; prostaglandin E2 analogues, e.g. , sulprostone; and EP2 receptor agonists, such as butaprost; 5α-reductase inhibitors Agents such as finasteride, dutasteride, turosteride, bexalosteride, isopropyl catechin, epristeride, epigallocatechin, fluridil (Sovak et al., Dermatol. Surg. 2002;28(8):678-685), RU 58841 (Pan et al., Endocrine. 1998;9(1):39-43), N,N -Diethyl-4-methyl-3-oxo-4-aza-5 alpha-androstane-17 beta-carboxamide Samid (Rittmaster et al., J Clin Endocrinol Metab. 1987;65(1):188-193), MK-386, Azelaic acid, FCE 28260, SKF 105,111; Minoxidil; ATP-sensitive potassium channel opening drugs, e.g., diazoxide; and drugs as described herein or otherwise known in the art. Hair growth promoters known in the art, such as kopexil (e.g., the product Keranique®), CaC l2, botulinum toxin A, adenosine, ketoconazole, DoxoRx, docetaxel, FK506 , GP11046, GP11511, LGD 1331, ICX-TRC, MTS-01, NEOSH101, HYG-102440, HYG-410, HY G-420, HYG-430, HYG-440, Spironolactone, CB-03-01, RK-023, Abatacept, Vivis cal (registered trademark), MorrF, ASC-J9, NP-619, AS101, Metron-F-1, PSK 3841, Targretin ( For example, 1% gel), MedinGel, PF3187207, BOL303259X, AS604872, THG11331, PF-277343 , PF-3004459, Raptiva, caffeine, and coffee. Other hair growth promoters include arginine, isoleucine, leucine, lysine, and methionine. Nine, phenylalanine, threonine, tryptophan, valine, gamma-linolenic acid and Polyphenol catechin and copper peptide are included. Formulated as a hair washing tonic. Other hair growth stimulants that can help are jojoba oil, apple extract, saw palmetto, emu Oils, beta carotene, and green tea are examples of other antioxidants. In the method, the applicator is a device for treating alopecia that is being developed by SWITCH Biotech LLC. Other drugs may be used in combination with drugs for and Company ID: Actelion ACT-129968 (setipiprant), Actimis AP768, Amira AM211, Amira AM461, Amgen AMG853, Array BiPharma ARRY-502, AstraZeneca AZD1981, AstraZeneca A ZD8075, AstraZeneca AZD5985, Merck MK-7246, Novartis QAV680, Oxagen OC000459, Oc agen OC002417, Pulmagen ADC3680B, Shionogi S-555739, BBI-5000, SM04554, and KYTH 105 (setipiprant). For example, proteasome inhibitors such as lactacystin, peptidyl aldehydes, or peptides may be used. Examples include ptoxifylline (PTX).

[0273] In one embodiment, the agent is an agent useful for reducing wrinkles. Such agents are known in the art. Non-limiting examples of agents useful for reducing wrinkles include: Examples include immune response modifier (IRM) compounds, such as idazoquinoline. Amines, tetrahydroimidazoquinoline amines, imidazopyridine amines, 1,2-bridged imidazopyridine amines Dazoquinoline amines, 6,7-fused cycloalkyl imidazopyridine amines, imidazonaphthyl Lysine amines, tetrahydroimidazonaphthyridine amines, oxazoloquinoline amines, Thiazoloquinoline amines, oxazolopyridine amines, thiazolopyridine amines, oxazolopyridine amines azolonaphthyridine amine, thiazolonapthyridine amine, or a combination thereof. can be done.

[0274] In one embodiment, the agent is an agent useful in scar formation. Useful agents are known in the art. Non-limiting examples of agents useful in scar formation include: Specific examples include immune response modifier (IRM) compounds, such as imidazoquinoline amines, tetracyclines, and the like. Hydroimidazoquinoline amines, imidazopyridine amines, 1,2-bridged imidazoquinolines Amines, 6,7-fused cycloalkyl imidazopyridine amines, imidazonaphthyridine amines , tetrahydroimidazonaphthyridinamine, oxazoloquinolineamine, thiazoloquinoline Phosphorus amines, oxazolopyridine amines, thiazolopyridine amines, oxazolonaphthyl naphthyridine amines, thiazolonaphthyridine amines, or combinations thereof.

[0275] In one embodiment, the agent is an agent useful in hair loss. Non-limiting examples of agents useful in hair loss include nicotinamide, nicotinamide-containing agents, and nicotinamide-containing agents. Thiandrogens, androgen inhibitors, chromaphores, photosensitizers Agents, enzymes, phosphonic acid derivatives, matrix metalloproteinases, and combinations thereof Examples include:

[0276] In one embodiment, the agent is an agent useful in tattoo removal. Such agents are known in the art. Non-Limiting Examples of Agents Useful in Tattoo Removal Examples of such compounds include immune response modifier (IRM) compounds, e.g., compounds with antiviral and / or antitumor activity. compounds that induce the production and secretion of cytokines, purine derivatives, imidazoquinones Phosphorus amide derivatives, imidazopyridine derivatives, benzimidazole derivatives, five-membered nitrogen-containing Derivatives of 4-aminopyrimidine fused to heterocycles, including certain 3-beta-D-ribofuranosyl Thiazolo[4,5-d]pyrimidine derivatives, and aminoalkyl glucosaminide phosphates, 5 % Imiquimod (1-(2-methylpropyl)-1H-imidazo[4,5-c]quinolin-4-amine) cream Some examples include:

[0277] In one embodiment, the agent is an agent useful in pigmentation. Such agents are known in the art. Non-Limiting Examples of Agents Useful in Pigmentation These include vitamin C derivatives, niacinamide, cucumber extract, lemon extract, and S -acyl glutathione derivatives.

[0278] In another embodiment, the agent is a local anesthetic.

[0279] As used herein, the terms "compound" and "agent" are used interchangeably.

[0280] (5.6.1 Hair growth promoters) In specific embodiments, the compounds described herein are hair growth promoters.

[0281] The integument perturbation methods described in Section 5.1 above can be used alone or in combination with the methods described in Section 5.2 above. In combination with the post-perturbation treatment described above, the combination treatment with hair growth promoters may optionally include the following: In some embodiments, the therapeutic agents may be used in combination with the therapeutic agents described in Section 5.4. In the present invention, the hair growth promoting agent described herein promotes hair follicle development and growth, and is effective in treating areas of the skin. In some embodiments, the hair follicle is transformed into a non-vellus hair, such as intermediate or terminal hair. In this manner, the hair growth promoter described herein acts synergistically with the integument perturbation method to promote hair growth. The benefits of each treatment may be additive or synergistic, or the combination of two different The combination of different biologically defined effects can be used to achieve the desired end result.

[0282] In some embodiments, the hair growth promoter is used to promote hair growth and / or treat excessive hair loss. Therapies that treat the associated disease or condition are known or have yet to be developed in the art. To promote undeveloped hair growth and / or treat diseases or conditions associated with excessive hair loss Any treatment that is contemplated for use in accordance with these embodiments.

[0283] In some embodiments, the hair growth promoting agent treatment is, for example, minoxidil (e.g., Rog one or more of the following drugs: Channel openers (e.g., potassium channel openers, e.g., ATP-sensitive potassium channel This includes treatment with certain drugs (KATP openers, or activators of such channels). In embodiments, the hair growth stimulant treatment includes treatment with minoxidil. Commonly used formulations of minoxidil that may be used include 2% minoxidil or 5% minoxidil. Topical solutions containing minoxidil, such as topical minoxidil foam 5%.

[0284] In some embodiments, the hair growth-promoting treatment includes treatment with one or more 5α-reductase inhibitors. Non-limiting examples of 5α-reductase inhibitors include finasteride, dutasteride, steroids (e.g., Avodart), turosteride, bexalosteride, izonsteride, epristelide These include catechin, epigallocatechin, MK-386, azelaic acid, FCE 28260, and SKF 105,111. Commonly used formulations of finasteride that may be used in such treatments include, for example: and oral finasteride 1 mg / day. For example, each of which is incorporated herein by reference in its entirety. Incorporated into the Physicians' Desk Reference, 2009, Vol. 63rd ed., Montvale, NJ: Physicians' Desk Reference, Inc., Propecia® and Proscar® Entries for Propecia® and Proscar®, 2095-2 Please see pages 099 and 2102-2106.

[0285] In some embodiments, the hair growth promoting agent treatment is, for example, finasteride (e.g., P Ropecia or Proscar), ketoconazole, fluconazole, spiro Nolactone, flutamide, diazoxide, 17-alpha-hydroxyprogesterone, 11- Alpha-hydroxyprogesterone, ketoconazole, RU58841, dutasteride (Avoda rt), fluridil, or QLT-7704; Anti-androgenic oligonucleotides, the contents of which are incorporated herein by reference. Poulos and Mirmirani, 2005, Expert Opin. Investig. Drugs 14:177-184. This includes treatment with other medications listed in the literature.

[0286] In some embodiments, the hair growth promoting agent treatment comprises one or more prostaglandin F2α This includes treatment with prostaglandin analogs, prostaglandin analogs, or prostaglandins. Non-limiting examples of ranin F2α analogs include bimatoprost (e.g., Latisse, Lumiga n), latanoprost (brand name Xalatan), travoprost (brand name Travatan), tafluprost , unoprostone, dinoprost (trade name Prostin F2 Alpha), AS604872, BOL303259X, PF3187207, carboprost (trade name Hemabate). Exemplary prostaglandin F2α analogs for use with For therapeutic regimens, see, e.g., US Pat. No. 6,393,623, the entire contents of each of which are incorporated herein by reference in their entirety. Incorporated U.S. Pat. Nos. 8,017,655, 5,688,819, 6,403,649, 5,510,3 No. 83, No. 5,631,287, No. 5,849,792, No. 5,889,052, No. 6,011,062, No. 7,163,959 See, e.g., 5,296,504, 5,422,368, 6,429,226, and 6,946,120. Also, with respect to latanoprost, the contents of which are incorporated herein by reference in their entirety. See Uno et al., 2002, Acta Derm Venereol 82:7-12.

[0287] In some embodiments, the hair growth promoter treatment comprises one or more of the following hair growth promoters: kopexil (e.g., For example, the product Keranique (trademark), CaCl2, botulinum toxin A, adenosine, ketoconazole , DoxoRx, docetaxel, FK506, GP11046, GP11511, LGD 1331, ICX-TRC, MTS-01, NEOS H101, HYG-102440, HYG-410, HYG-420, HYG-430, HYG-440, Spironolactone, CB-03-01 , RK-023, Abatacept, Viviscal (registered trademark), MorrF, ASC-J9, NP-619, AS101, Metron -F-1, PSK 3841, Targretin (e.g., 1% gel), MedinGel, PF3187207, BOL303259X, AS604872, THG11331, PF-277343, PF-3004459, Raptiva, caffeine, and coffee sac In some embodiments, the hair growth-promoting agent treatment includes treatment with one or more of the following: Includes a drug for alopecia being developed by Biotech LLC.

[0288] In some embodiments, the hair growth promoter treatment includes the following: herbs (e.g., sawdust, Palmetto, soybean oil (glycine soja), ginseng (Panax ginseng), European chestnut ( Castanea Sativa), Arnica Montana, Hedera Helix Gelani Hedera Helix Geranium Maculatum, etc.), Triamcinolone Acetoacetate nido (e.g., 2.5-5 mg / ml injectable suspension), local irritants (e.g., anthralin), or Sensitizers (e.g., squaric acid dibutyl ester [SADBE] or diphenylcyclopropenone) [DPCP]), clomipramine, unsaturated fatty acids (e.g., gamma-linolenic acid), fatty acid derivatives, Thickening agents (e.g., carbomer, glycol distearate, cetearyl alcohol, etc.), Hair loss concealer, niacin, nicotinic acid esters and salts, adenosine, and methionine In some embodiments, the hair growth-promoting agent treatment includes treatment with one or more of the following: , including treatment with nitroxide spin labels (e.g., TEMPO and TEMPOL). See U.S. Patent No. 5,714,482, which is incorporated herein by reference.

[0289] In some embodiments, the hair growth stimulant treatment is useful for stimulating scalp hair growth. This includes treatment with androgen receptor inhibitors, which have been shown to be effective in treating org Med Chem Lett. 2007 17:5983-5988).

[0290] In some embodiments, the hair growth promoter treatment is preferably a topically applied copper pentahydrate. The present invention includes treatment with a peptide (s), or another compound that has superoxide dismutation activity. In some embodiments, the hair growth promoting treatment includes an agent that increases nitric oxide production (e.g., For example, arginine, citrulline, nitroglycerin, amyl nitrite, or sildenafil. In a preferred embodiment, such a compound is catalase. or catalase mimetics, or other antioxidants or free radical scavengers It is further administered in combination with

[0291] In some embodiments, the hair growth promoting agent treatment comprises a compound that mobilizes bone marrow derived stem cells ( For example, growth factors such as G-CSF and / or chemicals such as plerixafor (Mozobil®). and / or modulating the differentiation of these stem cells into gender-specific, dedicated human hair follicles. For example, the explantation of specialized hair follicles that have characteristics different from natural hair follicles at a target site on the skin. Compounds capable of producing the effects (e.g., finasteride, known in the art) , fluconazole, spironolactone, flutamide, diazoxide, 11-alpha-hydro oxyprogesterone, ketoconazole, RU58841, dutasteride, fluridil, or QLT -7704, antiandrogenic oligonucleotide, cyoctol, topical progesterone , topical estrogen, cyproterone acetate, ru58841, combination 5α-reductase inhibitor, oral Contraceptives, and Poulos and Mirmirani, 2005, incorporated herein by reference. Expert Opin. Investig. Drugs 14:177-184, or any other anti-estrogen Antibodies, estrogens, or estrogen-like drugs (either alone or in combination with other drugs that increase stem cell plasticity) This includes treatment with drugs such as valproic acid (for example, in combination with nothing.

[0292] In some embodiments, the hair growth promoting agent treatment is to treat age-related thinning of hair and / or hair follicles. One or more agents that combat cellular senescence (also referred to herein as "anti-aging agents"), e.g., Glutathione, ascorbic acid, tocopherol, uric acid, or polyphenol antioxidants Antioxidants such as erythrocyte sedimentation inhibitors; inhibitors of reactive oxygen species (ROS) generation such as superoxide dismutase inhibitors; stimulators of ROS degradation such as selenium; mTOR inhibitors such as rapamycin; or resveratrol. activators, such as SIRT1 and SIRT3 activators, or other sirtuins or their activators. This includes treatment with beta- or nicotinamide inhibitors.

[0293] In some embodiments, the hair growth promoting agent treatment is, for example, tetanus toxoid, topical Nonspecific irritants (anthralin) or sensitizers (squaric acid dibutyl ester [SADBE] and Diphenylcyclopropenone [DPCP], which induces an immune response or causes inflammation Without intending to be bound by any theory, By contacting the skin with these drugs, lymphocytes and hair follicle stem cells are mobilized to the skin. In some embodiments, the hair growth promoting agent treatment is This includes treatment with chemical or mechanical (such as those described below) treatments that induce an inflammatory process. Without intending to be bound by any theory, inflammation in the area where hair growth is desired Inducing this disease helps mobilize stem cells into the tissue that drives the formation of new hair follicles. .

[0294] In some embodiments, the hair growth promoting treatment comprises treatment with an anti-apoptotic compound. In one embodiment, the anti-apoptotic compound is not a Wnt or a Wnt agonist. .

[0295] In some embodiments, the hair growth promoting treatment is stem cell therapy, hair cloning, hair For hair transplants, scalp massages, skin grafts, hair plugs, follicular unit extractions, or hair growth purposes This includes any surgical procedure to treat

[0296] In some embodiments, the hair growth promoting agents described herein are those that are known in the art for such agents. The drug may be used at a dose or within a range of doses known in the art (e.g., as described in the package insert or for use by a physician). (as available in the desk reference). In another embodiment, the hair growth promoter is The dose may be adjusted according to the combination therapy described herein (e.g., treatment with integumental perturbation or another active ingredient). For example, the usual dose may be adjusted to optimize treatment as prescribed by a physician. For example, in combination with another treatment as described herein, Due to the synergistic effects of the two, lower doses may be used for shorter periods of time.

[0297] In some embodiments, the hair growth promoter may be used in its commercially available form. In other embodiments, the hair growth promoting agent is in the form of a combination treatment described herein (e.g., In certain embodiments, the method is adjusted to optimize the amount of the active ingredient (e.g., skin perturbation, or treatment with another active ingredient). In the present invention, the hair growth promoter is formulated as a salt form different from that which is commercially available. In certain embodiments, the hair growth promoting agent is, for example, a hair growth promoting agent as described in Section 5.2 below. The compound is formulated for topical administration by incorporation into a pharmaceutical composition for post-perturbation treatment.

[0298] In some embodiments, the hair growth-promoting agent enhances the conversion of vellus hair to non-vellus hair. In certain embodiments, the hair growth-promoting agent enhances the conversion of vellus hair to terminal hair. Exemplary hair growth promoters that promote the conversion of vellus hair to non-vellus hair may be used in some embodiments. , prostaglandin F2α analogues (in one embodiment, latanoprost), minoxidil, etc. In some embodiments, the hair growth-promoting agent converts telogen hair to anagen hair. In certain embodiments, the hair growth-promoting agent enhances the conversion of telogen hair to anagen hair. Exemplary telogen hair to anagen hair that may be used according to these embodiments The hair growth promoter that promotes the conversion of prostaglandin F2α analogues (in one embodiment, latam Noprost), minoxidil, etc.

[0299] In some embodiments, the hair growth promoting agent treatment is an antiandrogen (e.g., 5α-reductase These include treatment with vasopressin (proenzyme inhibitors) and channel openers (e.g., minoxidil). In one embodiment, a 5α-reductase inhibitor is administered in combination with minoxidil. In one such embodiment, finasteride is combined with minoxidil. In some embodiments, the hair growth promoting agent treatment is administered in combination with a channel opener (e.g., Prostaglandin F2α or prostamide analogues (e.g., minoxidil) in combination with For example, latanoprost, bimatoprost, etc. In one, prostaglandin F2α or a prostamide analog is combined with minoxidil. In one such embodiment, latanoprost is administered in combination with minoxidil. In another such embodiment, bimatoprost is administered in combination with mitomycin. It is administered in combination with Noxidil.

[0300] In some embodiments, the method of claim 1, further comprising administering to a subject a method for promoting hair growth in a female subject, comprising administering to a subject a method for promoting hair growth in a female subject, the method ... The treatment described does not include finasteride or ketoconazole. In accordance with the present invention, the treatments described herein for promoting hair growth in pregnant female subjects include: It's not finasteride or ketoconazole.

[0301] In some embodiments, the treatments described herein for promoting hair growth include: In some embodiments, the composition of the present invention for promoting hair growth is free of minoxidil. The treatments described herein do not include finasteride. The treatments described herein for promoting balding do not include dutasteride. In one embodiment, the treatment described herein for promoting hair growth comprises fluridil. In some embodiments, the method of claim 1, further comprising administering to said patient a therapeutically effective amount of the composition described herein for promoting hair growth. In some embodiments, the treatment does not include spironolactone. The treatments described herein for treating rheumatoid arthritis do not include cyproterone acetate. In such cases, the treatments described herein for promoting hair growth include bicalutamide. In some embodiments, the treatments described herein for promoting hair growth are In some embodiments, the present invention is directed to promoting hair growth. The treatments described herein do not include nilutamide. The treatments described herein for promoting androgen receptor activation do not include inhibitors of the androgen receptor. In some embodiments, the treatments described herein for promoting hair growth include: In some embodiments, the composition is free of androgen antagonists and promotes hair growth. The treatments described herein for treating androgen-induced rheumatoid arthritis do not include antiandrogens.

[0302] (5.7 doses) The dosage of the drug used by the devices and / or methods provided herein may be The efficacy and safety of these drugs should be adjusted to achieve the greatest benefit while reducing possible side effects.

[0303] In some embodiments, the target concentration of the agent is maintained for at least 1 day; at least 2 days; at least 3 days;at least 4 days;at least 5 days;at least 6 days;at least 7 days;at least 8 days; At least 9 days;At least 10 days;At least 11 days;At least 12 days;At least 13 days;At least at least 14 days; at least 15 days; at least 16 days; at least 19 days; or at least 21 days; and In one embodiment, the compound is maintained in the skin or blood, preferably in the skin, for no more than 28 days. In some embodiments, the target concentration of the drug should be maintained for one month or more, two months or more, Persist in the skin or blood, preferably in the skin, for 3 months or more, 3 to 6 months or more, or 6 to 12 months or more. This can be achieved, for example, by repeated application of the drug or by the use of slow or sustained release drug formulations. This can be achieved using a single application. For example, a modified release form can be used to achieve a shorter sustained period ( That is, the target concentration of the drug can be achieved for at least 1, 2, or 3 days. Longer maintenance periods may require repeated applications of drug treatment. In some embodiments, it is preferred that the concentration of the drug be decreased between doses.

[0304] Care must be taken to avoid toxicity. In this regard, it is important to develop effective treatments that minimize toxicity. The dose should be selected to maximize efficacy. Patients should be monitored under standard clinical practice for toxic side effects. In some embodiments, the drug dosage should be monitored by clinical practice. Based on blood levels (serum or plasma) taken 12 or 24 hours (by convention) after the subsequent dose The administration of a single test dose should result in a skin response followed by a peak concentration time. Skin and / or blood sample assay (plasma or serum); followed by 12- or 24-hour trough concentrations and control values ​​at 24, 48 or 96 hours (when the hair growth promoter has been eliminated from the system). Predicting dose requirements for individual patients based on blood sample assays that monitor toxicity Once a patient dose has been established, routine toxicity testing may be possible. Sexual monitoring is recommended. Check minoxidil sulfotransferase levels. predict who will respond better to minoxidil by (Buhl et al., J Invest Dermatol. 1990;95(5):553-557).

[0305] In another embodiment, the dose of the agent is administered in accordance with the biological therapy described in Section 5.4.5(a). A dose sufficient to achieve one or more of the outcomes.

[0306] 5.8 Combination of kits and devices In one example, the devices described above may each be sold separately packaged and They may be packaged and sold together in separate packages, or they may be packaged and sold together.

[0307] For example, the needle insertion device may be provided with a needle insertion device, an adapter sheath with a rectangular needle insertion array, and a charging The needle insertion device may be sold in a package that includes a charging station. The needle insertion device may also be sold without a needle insertion array, e.g., a precision tip. one or more additional needle insertion adapters or sheaths having a circular needle insertion array for providing They may be sold together.

[0308] In another example, any of the embodiments of the needle insertion device and components described above may be used with a fluid or The drug may be sold together with a drug applicator. The drug applicator may be an applicator device. , one or more massage heads, one or more massage cartridges, and an applicator charger. A station may be provided.

[0309] In a further example, the needle insertion device and applicator include a needle insertion device, a needle insertion sheath adapter, a fluid applicator, a fluid cartridge, one or more charging stations, and a needle insertion device. Each device can be used for procedures that include, separately or in combination, massage, and fluid administration cycles. Software or downloadable mobile apps for controlling together and / or separately These will be sold together as a system with a preamplifier.

[0310] Changes may be made to the above-described embodiments without departing from the broad inventive concept thereof. It will be appreciated by those skilled in the art that the invention disclosed herein is The present invention is not limited to any particular embodiment, but is intended to be illustrative and not restrictive of the principles of the present invention as defined by the appended claims. It is understood that all modifications within the spirit and scope are intended to be covered.

Claims

1. a sheath assembly comprising a needle array; and a main unit comprising a motor for driving the needle array; A needle insertion device comprising: The main unit is configured to be completely enclosed within the sheath assembly, The needle insertion device, wherein all parts of the knit are protected from the external environment.

2. The needle array is aligned with the motor in a direction parallel to a longitudinal axis of the needle insertion device along which the needle insertion device extends.

2. The needle insertion device of claim 1, wherein the needle insertion device is axially driven by a rotor.

3. The needle insertion device is used for needle insertion into a human scalp for promoting hair growth, and for skin repair. Claims adapted for performing needling of tissue or needling of scar tissue for scar removal.

1. A needle insertion device as described in claim 1.

4. The needle insertion device is adapted to treat baldness or chemotherapy-induced alopecia. The needle insertion method according to claim 3.

5. The needle insertion device is adapted to disrupt the basal or suprabasal epidermal layer of human skin. The needle insertion device of claim 1.

6. The sheath assembly completely covers the main unit, resulting in the main unit being 10. The needle insertion device of claim 1, which keeps the knit substantially aseptic, sterile, or free of biological contaminants. 。

7. Further comprising a biological barrier within the sheath assembly to prevent contamination from the subject's blood.

7. The needle insertion device of claim 6.

8. The needle insertion device of claim 1 , wherein the sheath assembly further comprises a sheath cap.

9. The sheath cap is removable for inserting or removing the main unit. The needle insertion device of claim 8.

10. The sheath cap removes the fully enclosed main unit from within the sheath assembly.

10. The needle insertion device of claim 8, configured to control the depth of the needle array without removing the needle. Device.

11. The depth of the needle array extends beyond the end of the sheath assembly toward the skin of a subject. from a depth at which it extends away from the subject's skin to a depth at which it is completely retracted within the sheath assembly.

11. The needle insertion device of claim 10, wherein the needle insertion device has a range of degrees.

12. The main unit further comprises a main unit cap, and the sheath cap is 10. The needle insertion device of claim 8, configured to rotate the knit cap.

13. without removing the fully enclosed main unit from within the sheath assembly. and one or more buttons located on a surface of the sheath assembly for controlling a needle insertion device.

2. The needle insertion device of claim 1 .

14. The one or more buttons may be used to control the depth of the needle array, the needle insertion speed, power to the needle insertion device, and LEDs for illuminating the disturbed area. The needle insertion device described.

15. The main unit includes a main unit cap and a drive for controlling the depth of the needle array. a shuttle chassis, the sheath assembly further comprising a sheath cap; and In response to a user rotating the sheath cap, the main unit cap is rotated. The drive shuttle chassis is axially displaced and the depth of the needle array is adjusted.

2. The needle insertion device of claim 1.

16. 16. The needle insertion device of claim 15, wherein the needle insertion device eliminates needle drag on the subject's skin. Device.

17. The needle array comprises a rectangular base and two substantially parallel rows of needles on the rectangular base. As a result, the needle insertion speed is increased and the number of needle insertion strokes is reduced.

1. A needle insertion device as described in claim 1.

18. The main unit is configured to contact the needle array to control needle insertion.

10. The needle insertion device of claim 1, further comprising a drive shaft.

19. The main unit further comprises a drive cam, and the drive cam controls positive movement of the needle array. a drive shaft for actively controlling the actuation and return motion of the drive shaft; is toward the skin of a subject, and the return motion is away from the skin of the subject and forward.

20. The needle insertion device of claim 18, which is directed to a needle insertion device.

20. The needle insertion device is adapted to eliminate vibrations when operating the needle insertion device, thereby reducing fatigue on the user's hands.

20. The needle insertion device of claim 19, configured to reduce effort.

21. The drive cam is attached to the drive shaft for reducing vibration of the needle array.

20. The needle insertion device of claim 19, comprising a slot for retaining the kicked pin.

22. The main unit is attached to the motor for controlling the forward and return motions of needle insertion. a driving cam attached to the skin of the subject, the positive motion being toward the skin of the subject; and the return motion is away from the skin of the subject and toward the needle insertion device. Item 1. A needle insertion device as described in item 1.

23. means for emitting infrared light, said needle array and said emitting means for detecting hair follicles on the scalp of the subject; 2. The needle insertion device of claim 1, wherein the needle insertion device is capable of stimulating using both infrared light and infrared radiation.

24. 13. The needle insertion method of claim 1, further comprising a light source for illuminating a target area on the skin of a subject. Device.

25. a sheath assembly comprising a needle array; and A main unit including a motor for driving the needle array. A needle insertion device comprising: The needle array comprises a rectangular base and two substantially parallel rows of needles on the rectangular base. As a result, the needle insertion speed is increased and the number of needle insertion strokes is reduced. input device.

26. a sheath assembly comprising a needle array; and a main unit comprising a motor for driving the needle array; A needle insertion device comprising: The main unit includes a main unit cap and a drive shaft for controlling the depth of the needle array. the sheath assembly further comprising a sheath cap, and In response to the driver rotating the sheath cap, the main unit cap is rotated and the drive a moving shuttle chassis is axially displaced and the depth of the needle array is adjusted; Needle insertion device.

27. a sheath assembly comprising a needle array; and a main unit comprising a motor for driving the needle array; A needle insertion device comprising: The main unit includes a drive unit configured to contact the needle array to control needle insertion. a drive shaft, and a drive cam; The drive cam drives the drive system to actively control the forward and return motion of the needle array. a shaft attached to said shaft, said positive motion being toward the skin of said subject, and said return motion being toward said skin of said subject; away from the skin of the subject and towards the needle insertion device.

28. 1. A method of using a needle insertion device to stimulate hair growth, comprising: a sheath assembly comprising a needle array; and a main unit comprising a motor for driving the needle array; To provide a needle insertion device comprising: The sheath assembly is opened to reveal that the main unit is completely enclosed and protected from the external environment. disposing the main unit within the sheath assembly such that Turning on the needle insertion device The method comprising:

29. the sheath assembly comprises a needle array, and the method removing the sheath assembly; and Replacing the sheath assembly with another sheath assembly having a different needle array.

30. The method of claim 28, further comprising:

30. 1. A method of using a needle insertion device and a drug applicator to stimulate hair growth, comprising: a sheath assembly comprising a needle array; and a main unit comprising a motor for driving the needle array; To provide a needle insertion device comprising: housing; a drug delivery cartridge carried by the housing; and a massage head mounted on the housing for massaging the skin of a subject. D; To provide a drug applicator for drug delivery and massage comprising: Using the needle insertion device to perform targeted skin disruption to destroy layers of the human scalp; and Beauty After using the needle insertion device, a drug is applied to the disrupted layer of the human scalp. Using a substance applicator The method comprising:

31. The disrupted layer of the human scalp is the basal layer or the suprabasal layer of the epidermis, and The drug used is minoxidil, or lactacystin, peptidyl aldehyde, or 31. The method of claim 30, wherein the agent is a proteasome inhibitor such as pentoxifylline (PTX).

32. and delivering the drug directly to the human scalp to facilitate transdermal transport. The method of claim 31.

33. The drug delivered to the human scalp (scap) is massaged to spread the drug evenly.

32. The method of claim 31, further comprising:

34. housing; Drug delivery cartridges; and A massage head mounted on the housing.

1. An applicator for drug delivery and massage comprising: The drug delivery cartridge is delivered by a dosing mechanism coupled to the movement of the massage head. The applicator is configured to automatically administer the medication.

35. configured to stretch or massage the skin of a subject while administering the drug.

35. The applicator of claim 34.

36. The amount of drug being administered is determined by the number of massage strokes per massage cycle, Controlling the stroke distance per massage cycle or profile of the dosing mechanism 35. The applicator of claim 34, which can be controlled by

37. The applied drug is minoxidil, or lactacystin, a peptidyl aldehyde, or a proteasome inhibitor such as pentoxifylline (PTX), according to claim 34. Applicator.

38. The drug delivery cartridge and the massage head are attached by a user.

35. The applicator of claim 34, adapted to be installed and simultaneously removed and replaced. Eater.

39. 34. The massage head according to claim 33, wherein the massage head comprises a rigid disk and a resilient massage element. The applicator as described.

40. The speed of the movement of the massage head and the vibration frequency of the massage action part are 35. The applicator of claim 34, wherein the applicator is adjustable by a user.

41. The adjustable vibration frequency of the massaging portion is 1 Hertz, 2 Hertz, and 4 Hertz.

41. The applicator of claim 40, comprising:

42. A rotation angle of the massage head is detected, and the detected angle is used to determine the administered dose.

35. The method of claim 34, further comprising: Applicator.

43. The applicator can be operated in a massage-only mode or a massage and dispense mode.

35. The applicator of claim 34,

44. The rotation angle of the massage head is set so that the applicator is in the massage only mode.

35. The apparatus of claim 34, wherein the control unit controls whether the massage and administration mode is in the massage and administration mode. Applicator.

45. The applicator of claim 34, further comprising a keypad disposed on a surface of the applicator. Applicator.

46. and configured to operate the LED in response to determining that the next dose is due.

35. The applicator of claim 34, further comprising a control unit integrated therein.

47. a battery configured to receive the housing for charging the applicator; 35. The applicator of claim 34, further comprising a magnetic inductive charging base.

48. 35. The app of claim 34, further comprising a light source for illuminating a target area on the subject's skin. Caterer.

49. housing, a drug delivery cartridge carried by said housing for administering a drug; a massage head mounted on the housing for massaging the skin of a subject. ; The drug delivery cartridge is mounted within the housing and provides a massaging effect. A cam drive unit that rotates the cartridge and the massage head; and A rotation angle of the massage head is detected, and the detected angle is used to calculate the administered dose. A controller and a sensor configured to determine:

13. An applicator for drug delivery and massage comprising:

50. The drug delivery cartridge and massage head are attached by a user.

50. The applicator of claim 49, configured to be simultaneously removed and replaced. -

51. 49. The massage head according to claim 49, wherein the massage head comprises a rigid disk and a resilient massage element. The applicator as described.

52. The speed of rotation of the massage head and the vibration frequency of the massage action part are 50. The applicator of claim 49, wherein the applicator is adjustable by a user.

53. The adjustable vibration frequency of the massaging portion is 1 Hertz, 2 Hertz, and 4 Hertz.

53. The applicator of claim 52, comprising:

54. The applicator can be operated in a massage-only mode or a massage and dispense mode.

50. The applicator of claim 49, wherein the applicator is operable to

55. The rotation angle of the massage head is set so that the applicator can only perform the massage.

55. The application of claim 54, wherein the application controls whether the massage and administration action is Caterer.

56. The applicator of claim 49, further comprising a keypad disposed on a surface of the applicator. Applicator.

57. and configured to operate the LED in response to determining that the next dose is due.

50. The applicator of claim 49, further comprising a control unit integrated therewith.

58. a battery configured to receive the housing for charging the applicator; 50. The applicator of claim 49, further comprising a magnetic inductive charging base.

59. housing, a drug delivery cartridge carried by the housing; and A massage head mounted on the housing. providing an applicator comprising: turning on the applicator; and Automatically administering medication via a delivery mechanism coupled to the movement of the massage head. A method of using the applicator for hair growth application comprising:

60. The massage head is attached to the drug delivery cartridge and is Equipped with a head nodule, The method further comprising: removing the massage head and attached drug delivery cartridge; and The massage head and attached drug delivery cartridge are then transferred to a separate drug delivery cart. Another massage head with ridges and different nodule arrangements. Replace with a new head.

60. The method of claim 59, further comprising:

61. The applied drug is minoxidil, or lactacystin, a peptidyl aldehyde, or a proteasome inhibitor such as pentoxifylline (PTX), according to claim 59. method.

62. 60. The method of claim 59, further comprising remotely controlling the applicator.

63. Receive notifications from the applicator using a remote user interface.

60. The method of claim 59, further comprising interacting with the applicator.

64. The remote user interface facilitates adherence to set parameters. The mobile application is configured to communicate with a user to 63. The method described in claim 63.

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