WO2024168033A1

WO2024168033A1 - Devices and methods for hair growth acceleration

Info

Publication number: WO2024168033A1
Application number: PCT/US2024/014797
Authority: WO
Inventors: Julian HENLEY
Original assignee: Henley Julian
Priority date: 2023-02-08
Filing date: 2024-02-07
Publication date: 2024-08-15

Abstract

A transdermal hair growth acceleration device is applied to a head of a user to drive a medicament solution into a scalp of the user via iontophoresis. The device includes an electrode network, a substrate, structural features, and an electronics module. The electrode network includes multiple channels including active electrodes and counter electrodes, each counter electrode paired with an associated active electrode. The substrate supports the electrode network and is worn on the head. The structural features protrude distally from a bottom surface of the substrate to space the bottom surface from the scalp of the user to create a reservoir for the medicament solution between the bottom surface and the scalp. The electronics module includes a controller and a current driver, wherein the controller cause the current driver to drive the active electrodes to deliver a current to the scalp via the medicament solution in the reservoir.

Description

DEVICES AND METHODS FOR HAIR GROWTH ACCELERATION

CROSS REFERENCE TO RELATED APPLICATION

[0001 ] The present application claims priority to U.S. Provisional Patent Application No. 63/483,941 , which was filed on February 8, 2023, and is entitled Devices and methods for Hair Growth Acceleration. The contents of the above- mentioned patent application are hereby incorporated by reference in its entirety.

[0002] This application also incorporates by reference in its entirety U.S. Appln. Ser. No. 16/008,366, filed December 19, 2016, now U.S. Patent No. 11 ,052,240 and U.S. Appln. Ser. No. 07/579,799, filed September 10, 1990, now U.S. Patent No. 5,160,316.

FIELD OF THE INVENTION

[0003] This application relates to devices and methods for hair growth acceleration. In particular, this application relates to wearable transdermal devices and methods of using wearable transdermal devices for hair growth acceleration.

BACKGROUND OF THE INVENTION

[0004] A variety of medicaments have been found to improve hair growth but their efficacy has been greatly limited by a lack of penetration of the skin and its robust keratin layer. Taking these medicaments systemically may overcome their limitation of minimal topical penetration. However, systemic use often results in undesirable side effects and toxicities. Thus, there is a need for improved transdermal delivery of these hair growth medicaments.

SUMMARY OF THE INVENTION

[0005] Reference will now be made in detail to the exemplary embodiments, which are illustrated in the accompanying drawings. Wherever possible, the same reference numbers will be used throughout the drawings to refer to the same or like parts. [0006] In a first exemplary embodiment of the present invention, a transdermal hair growth acceleration device is disclosed. The transdermal device is configured to be applied to a head of a user to drive a medicament solution into a scalp of the user via iontophoresis. The transdermal device may include an electrode network, a substrate, structural features, and an electronics module. The electrode network includes multiple channels including active electrodes and counter electrodes, each counter electrode paired with an associated active electrode. The substrate supports the electrode network and is configured to be worn on the head. The structural features protrude distally from a bottom surface of the substrate, wherein when the substrate is worn on the head, the structural features space the bottom surface from the scalp of the user to create a reservoir for the medicament solution between the bottom surface and the scalp. The electronics module includes a controller and a current driver in communication with the controller and the active electrodes of the electrode network. The controller causes the current driver to drive the active electrodes to deliver a current to the scalp via the medicament solution in the reservoir.

[0007] In one version of the transdermal device, each channel supplies an electrode that contacts approximately 1 cm2 to approximately 2 cm2 of the scalp.

[0008] In one version of the transdermal device, the controller causes the current driver to drive the active electrodes at a current flow of less than 1 mA flux /cm2 of electrode contact with the scalp per channel.

[0009] In one version of the transdermal device, the controller causes the current driver to drive the active electrodes at a current flow of less than 0.8 mA flux /cm2 of electrode contact with the scalp per channel.

[0010] In one version of the transdermal device, the controller causes the current driver to drive the active electrodes at a current flow of less than 0.6 mA flux /cm2 of electrode contact with the scalp per channel.

[0011 ] In one version of the transdermal device, the electrode network further includes vibrational elements and the electronics module includes an oscillation driver in communication with the controller and the vibration elements. The controller causes the oscillation driver to drive the vibration elements to deliver a vibration to the scalp. [0012] In one version of the transdermal device, wherein the structural features include at least one of an electrode assembly, a dedicated insulating element offset from the active electrodes, or an intermediate layer including a porous material, knit material, a honeycomb structure or a cellular structure. The electrode assembly may include an electrically insulative distal tip.

[0013] In one version of the transdermal device, upon being activated, the active electrodes gradually increase a level of current administration over an extended period of time until reaching a level of current appropriate for treatment.

[0014] In one version of the transdermal device, an active electrode on at least one channel has its current pulsed periodically to signal to the user the transdermal hair growth acceleration device is operating.

[0015] In one version of the transdermal device, the resulting reservoir has a height of between approximately 0.2 mm and approximately 2 mm.

[0016] In one version of the transdermal device, the resulting reservoir has a height of between approximately 0.5 mm and approximately 1 mm.

[0017] In a second exemplary embodiment of the present invention, a method of administering a medicament solution to a scalp of a user is disclosed. The medicament solution encourages hair growth in areas of the scalp suffering from hair loss, and the medicament solution is encouraged to penetrate the scalp by process of iontophoresis. The method includes applying a medicament solution to the scalp; applying a transdermal hair growth acceleration device to a head of a user and over the medicament solution, the device comprising an electrode network, a substrate, structural features and an electronics module, the electrode network being of multiple channels and including active electrodes and counter electrodes, each counter electrode paired with an associated active electrode, the substrate supporting the electrode network and configured to be worn on the head, the structural features protruding distally from a bottom surface of the substrate, the electronics module including a controller and a current driver in communication with the controller and the active electrodes of the electrode network; positioning the substrate on the head such that the structural features space the bottom surface from the scalp of the user to create a reservoir for the medicament solution between the bottom surface and the scalp; and using the controller to cause the current driver to drive the active electrodes to deliver a current to the scalp via the medicament solution in the reservoir, thereby driving the medicament solution into a scalp of the user via iontophoresis.

[0018] In one version of the method, each channel supplies an electrode that contacts approximately 1 cm2 to approximately 2 cm2 of the scalp.

[0019] In one version of the method, the controller causes the current driver to drive the active electrodes at a current flow of less than 1 mA flux /cm2 of electrode contact with the scalp per channel.

[0020] In one version of the method, the controller causes the current driver to drive the active electrodes at a current flow of less than 0.8 mA flux /cm2 of electrode contact with the scalp per channel.

[0021 ] In one version of the method, the controller causes the current driver to drive the active electrodes at a current flow of less than 0.6 mA flux /cm2 of electrode contact with the scalp per channel.

[0022] In one version of the method, the electrode network further includes vibrational elements and the electronics module includes an oscillation driver in communication with the controller and the vibration elements, wherein the controller causes the oscillation driver to drive the vibration elements to deliver a vibration to the scalp.

[0023] In one version of the method, wherein the structural features include at least one of an electrode assembly, a dedicated insulating element offset from the active electrodes, or an intermediate layer including a porous material, knit material, a honeycomb structure or a cellular structure.

[0024] In one version of the method, the electrode assembly includes an electrically insulative distal tip.

[0025] In one version of the method, the reservoir has a height of between approximately 0.2 mm and approximately 2 mm.

[0026] In one version of the method, the reservoir has a height of between approximately 0.5 mm and approximately 1 mm. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] The foregoing summary, as well as the following detailed description of preferred embodiments of the invention, will be better understood when read in conjunction with the appended drawings. To illustrate the invention, there are shown in the drawings embodiments which are presently preferred. It should be understood, however, that the invention is not limited to the precise arrangements and instrumentalities shown. In the drawings:

[0028] Figure 1 is a perspective view of a transdermal hair growth device according to an exemplary embodiment of the present disclosure.

[0029] Figure 2 is a perspective partial sectional view of the transdermal hair growth device from Figure 1 .

[0030] Figure 3A is a rear perspective view of the transdermal hair growth device from Figure 1 shown without a cap.

[0031 ] Figure 3B is a top view of the transdermal hair growth device from Figure 3A.

[0032] Figure 4 is bottom perspective view of the electrode and electronic unit of the transdermal hair growth device from Figures 3A and 3B.

[0033] Figure 5A is a rear-sectional view of electrodes of the transdermal hair growth device as taken along the section line 5-5 in Figure 3B.

[0034] Figure 5B is the same rear-sectional view of the electrodes of the transdermal hair growth device, except at another location on the user where the reservoir is less deep due to the user’s hair being less thick or long, for example.

[0035] Figure 5C is a rear-sectional view of an alternative electrode portion of the transdermal hair growth device taken along the line 5-5 in Figure 3B.

[0036] Figure 5D is the same view as depicted in Figure 5A, except illustrating that a piezoelectric vibrational element may form part of an electrode assembly with the piezoelectric vibrational element located within the confines of the insulation element.

[0037] Figure 5E is the same view as depicted in Figure 5D, except illustrating the piezoelectric vibrational element forming a distal tip of the electrode assembly. [0038] Figure 5F is the same view as depicted in Figure 5D, except illustrating the piezoelectric vibrational element forming a core of the electrode assembly.

[0039] Figure 5G is the same view as depicted in Figure 5D, except illustrating the piezoelectric vibrational element being offset from the electrode assembly.

[0040] Figure 5H is the same view as depicted in Figure 5D, except illustrating the piezoelectric vibrational element forming at least a portion of the dedicated offset insulating element.

[0041 ] Figure 5I is the same view as depicted in Figure 5D, except illustrating an intermediate layer that is a porous or knit material between the scalp and bottom surface of the mesh, the intermediate layer forming the structure to maintain the height or offset distance for the reservoir.

[0042] Figure 6A is a front perspective view of another transdermal hair growth device shown without a cap.

[0043] Figure 6B is a front view of the transdermal hair growth device of Figure 6A.

[0044] Figure 6C is a right view of the transdermal hair growth device of Figure 6A.

[0045] Figure 7A is a front perspective view of the transdermal hair growth device of Figure 6A shown without the electronics unit.

[0046] Figure 7B is a rear perspective view of the transdermal hair growth device of Figure 7A.

[0047] Figure 8 is a block diagram of the circuitry of the transdermal hair growth device of Figure 1 .

[0048] Figure 9 is a method of using the transdermal hair growth device.

DETAILED DESCRIPTION

[0049] Reference will now be made in detail to the exemplary embodiments, which are illustrated in the accompanying drawings. Wherever possible, the same reference numbers will be used throughout the drawings to refer to the same or like parts.

[0050] Described herein are transdermal hair growth acceleration devices and methods for improving the delivery of hair growth medicaments. Various medicaments may be used to treat alopecia, which is the partial or complete absence of hair from where it normally grows. Some of the more common forms of alopecia include alopecia areata, which is an autoimmune condition that causes hair to fall out and androgenic alopecia commonly referred to as male- or female-pattern baldness, which is a genetically predetermined condition caused by an excessive response to androgens. These conditions may be treated with a topically applied medicament, such as Minoxidil, Finasteride, Latanoprost, Bimatoprost, Fluridil, Ketoconazple, Spironolactone, Dutasteride, Melatonin, and topical estradiols.

[0051 ] Medicaments used to treat alopecia aerata may include immunological agents such as Tofacitinib and related JAK inhibitors. JAK inhibitors are a type of medication that functions by inhibiting the activity of one or more of the Janus kinase family of enzymes (JAK1 , JAK2, JAK3, TYK2), thereby interfering with the JAK-STAT signaling pathway. These inhibitors have therapeutic application that includes treatment for hair loss. JAK inhibitors may include for example, Ruxolitinib (INCB018424), Tofacitinib (CP-690550) Citrate, AZD1480, Fedratinib (SAR302503, TG101348), AT9283, AG-490 (Tyrphostin B42), Momelotinib (CYT387), Tofacitinib (CP- 690550, Tasocitinib), WP1066, TG101209, Gandotinib (LY2784544), NVP-BSK805 2HC1 , Baricitinib (LY3009104, INCB028050), AZ 960, CEP-33779, Pacritinib (SB1518), WHI-P154, XL019, S-Ruxolitinib (INCB018424), ZM 39923 HCI, Decernotinib (VX-509), Cerdulatinib (PRT062070, PRT2070), Filgotinib (GLPG0634), FLLL32, BMS-911543, Peficitinib (ASP015K, JNJ-54781532), GLPG0634 analogue, Go6976 and Curcumol.

[0052] In addition, medicaments may include various growth factors, such as fibroblast growth factors (FGF), vascular endothelial growth factor (VEGF), keratinocyte growth factor (KGF), transforming growth factors (TGF), insulin-like growth factors (IGF), and others. Medicaments may also include vitamins and other nutrients.

[0053] Figures 1 and 2 show an exemplary embodiment of a transdermal hair growth acceleration device 10 (also referred to hereinafter as the transdermal device 10 for brevity) worn on the head of a user 1 . The transdermal device 10 may be used in conjunction with a medicament, such as one or more of the above listed medicaments to help deliver it transdermally through the scalp. Although the transdermal device 10 is shown being worn on the head of the user 1 , other embodiments not shown may also be worn or applied anywhere else on the body as desired and may also be used to help deliver other medicaments to the scalp or other body parts for a different desired effect than hair growth. The transdermal device 10 includes a cover, such as a cap 20 with a chinstrap 22 for holding the cap 20 in place. The chinstrap 22 may be integral with the cap 20 or removable so that the cap 20 can be worn without the chinstrap 22. As shown, the chinstrap 22 includes a cut-out for the ear of the user 1 , effectively providing two attachment portions on each side of the cap 20, i.e. , in front of the ear and behind the ear, to provide a snug fit. In other embodiments, the chinstrap 22 may have a single attachment portion on each side of the cap 20. The cap 20 and the chinstrap 22 may be comprised of an elastic material, similar to a traditional swimming cap, or fabric with an embedded elastic band or portions to help adjust to different head sizes, improve comfort, and to help maintain the cap 20 in contact with the scalp. In some embodiments, the chinstrap 22 may comprise two separate end portions for adjusting and fastening together, such as strings or an adjustable strap. The cap 20 may also include strings or an adjustable strap on the rear portion thereof for adjusting the rim size.

[0054] The transdermal device 10 may include an electronics module 30 attached to the outside surface of the cap 20. In some embodiments, the electronics module 30 may be positioned on any other location of the hat, such as the back, top, or a side. The electronics module 30 may be configured for easy removal from the cap 20. Turning to Figure 2, the electronics module 30 may house a portion of a circuity 40 including electronic circuit elements for driving the electrodes 58 and their associated networks 51 , electronic circuit elements for driving vibration elements 65 (if present in a particular embodiment) and other electronic elements that are not specific to driving the electrode and vibration functionality of the device 10. The electronic module 30 may include a battery that powers the device 10. The electronics module 30 may be in electronic communication with the electrode network 51 embedded within a mesh 50 positioned underneath the cap 20. The mesh 50 and electrode network 51 are shown in Figs. 2-4.

[0055] The mesh 50 may be comprised of a non-conductive polymer open cell mesh with a hydrophilic or hydrophobic surface, or combination of the two depending upon the intended formulation. Combinations of hydrophilic and hydrophobic polymer meshes may accommodate the use of diverse agents with diverse solubilities in aqueous or oily solvents. In some embodiments, the cap 20 and the mesh 50 are depicted as separate layers. However, the cap 20 and the mesh 50 may be a single layer or integrated seamlessly as a single layer.

[0056] The electrode network 51 may include a plurality of conductive pathways 56 each of which being electrically connected to one or more electrodes 58. The conductive pathways 56 are embedded into the mesh 50 insulating it along its length between electrode connectors 60 and 62 (Figure 4) and the electrodes 58. The conductive pathways 56 may be conductive wires, conductive paint, or conductive traces made of any one or more of the well-known conductive metals, alloys or other conductive materials employed in electronic medical devices.

[0057] As shown in Figure 4, the electrode connectors 60 and 62 removably mate with module connectors 32 and 34, respectively, positioned on the electronics module 30 to allow the conductive pathways 56 and the electrodes 58 to communicate with the circuitry 40 within the electronics module 30. Unlike the insulated electrical pathways 56, the electrode 58 is exposed (i.e., not electrically insulated) at the underside of the mesh 50 making contact with a medicament reservoir 70 (shown in Figures 5A-5C and discussed below in more detail). The electrodes 58 are depicted as hexagonal rings with an open center, but in other embodiments the electrodes may be any other shape, such as circular and may be either open or solid filled. In some embodiments, each electrode 58 may correspond to a contact area on the user less than 0.5 cm2, between 0.5 cm2 and 2.5 cm2, or greater than 2.5 cm2. In a preferred embodiment, the contact area may be between approximately 1.0 cm2 and 2.0 cm2.

[0058] Returning to Figures 2-4, some of the electrodes 58 may be configured as working electrodes 54, which are shown positioned generally rearward of the electronics module 30 and connect to the module connector 34. The working electrodes 54 may be arranged according to a prearranged pattern. The prearranged pattern may be arranged in a pattern typical with male- or female-patterned baldness, customized to a particular user 1 , distributed evenly over the entire scalp, or arranged into any other desired pattern. To the front of the electronics module 30, some of the electrodes 58 may be configured as counter electrodes 52, which connect to the module connector 32. The counter electrodes 52 may be arranged in a pattern in a location of the mesh 50 corresponding to the forehead area of the user 1 . In other embodiments, the counter electrodes 52 may be positioned on the mesh 50 in a location corresponding to the neck, ear, or any other location of the user 1 .

[0059] The circuitry 40 is configured to generate an iontophoretic signal between at least one of the working electrodes 54 and one of the counter electrodes 52. The iontophoretic signal may be transmitted through a pair of electrodes, such as between one of the working electrodes 54 and one of the counter electrodes 52. In the embodiment shown in Figures 2-4, thirty-two (32) working electrodes 54 and thirty-two (32) counter electrodes are shown, where each of the thirty-two (32) electrodes are paired and grouped into four (4) discrete channels. The device may use any number of discrete channels, for example, 1 , 2, 4, 6, 8, 12, 16, 24, 32, 48, 64, 96, or more channels may be used. In addition, each channel may have any number of electrodes 58, for example, a channel may be in electrical communication with 1 , 2, 4, 6, 8, 12, 16, 24, 32, 48, 64, 96, or more electrodes 58. Furthermore, a particular channel may have a different number of working electrodes 54 than counter electrodes 52, such as, for example, having four (4) working electrode and a single counter electrode. Any permutation of channels and electrodes may be implemented. In other embodiments, the working electrodes 54 and the counter electrodes 52 may be multiplexed. [0060] Turning to Figures 5A-5C, the electro-kinetic activity of the transdermal device 10 with reference to a reservoir 70 is discussed. An electrical signal is generated by the circuitry 40 (which is described in more detail below) and transmitted through one of the conductive pathways 56 to one of the electrodes 58 of the working electrodes 54 through the reservoir 70 to one of the electrodes 58 of the counter electrode 52, through another one of the conductive pathways 56 back to the circuitry. The reservoir 70 may include one or more medicaments in solution 71 , such as those discussed previously, and optionally any other agent or additive. Such agents and additive may include any substance other than the medicament intended for stability, solubility, or any other purpose. For brevity, unless specifically noted otherwise, reference to the medicament will also include any additional agents or additives.

[0061 ] Figure 5A shows a rear-sectional view of electrodes 58 as taken along section line 5-5 in Figure 3B. Figure 5B shows the same rear-sectional view of other electrodes 58 at another location on the user 1 where the reservoir 70 is less deep due to the user’s hair being less thick or long, for example.

[0062] In Figures 5A and 5B, the electrodes 58 are shown as being embedded at least partially within the mesh 50 with an exposed (i.e., uninsulated) portion 59 of the electrode 58 making contact with the reservoir 70. Beneath the electrode 58 may be an insulating element 64 that may serve as an electrically non-conductive protruding spacer 64 to provide space between the bottom surface 57 of the mesh 50 and the user’s scalp surface 63 to provide a void in which the reservoir 70 may exist and to help prevent a direct electrical pathway from the electrode 58 to the scalp that bypasses the reservoir 70. In such an embodiment of the electrode having an insulating element 64, the exposed portion 59 may be a side surface of the electrode 58 and the insulating element 64 may be the bottom of the electrode 58, as depicted in Figures 5A and 5B. The insulating element 64 may be a non-conductive coating or, in other embodiments, the insulating element may be made substantially or entirely from a vibrational element such as, for example, a piezoelectric vibrational element. In such embodiments as depicted in Figures 5A and 5B, the combined electrode 58 and insulating element 64 may be considered an electrode assembly 66. Similarly, where there is also a piezoelectric vibrational element as discussed below with respect to Figures 5D-5F, the combined electrode 58, insulating element 64 and piezoelectric vibrational element 65 may be considered an electrode assembly 66.

[0063] In addition to the medicament solution 71 , the reservoir 70 may include one or more hairs 2, which in some cases, may be present at least to some extent on the user 1 . Due to the conductive properties of the protein keratin, of which the hairs 2 are comprised, the hairs 2 may provide a less resistive path for electrical charge and the charge is more readily carried by the hairs 2 to penetrate the scalp of the user 1 than through the scalp directly.

[0064] As shown in Figure 5A, when the hairs 2 of the user 1 are long and plentiful, they may act as a stopper to help ensure that a space for the reservoir 70 may form over the desired area between the scalp and the mesh 50. However, as depicted in Figure 5B, in the absence of long hairs or any hair, the extension of the electrode 58 of the electrode assembly 66 beyond the bottom surface 57 of the mesh 50 and the insulating element 64 forming the protruding distal termination of an electrode may help ensure that a space for the reservoir 70 may form over the desired area between the scalp surface 63 and the bottom surface 57 of the mesh 50.

[0065] As indicated in Figure 5B, the electrode assembly 66 by projecting distally out of the bottom surface 57 of the mesh 50 a distance L may result in a reservoir 70 having a depth of at least L between the bottom surface 57 of the mesh 50 and the scalp surface 63 of the user 1 . Depending on the embodiment, the distally projecting length L between the bottom surface 57 of the mesh 50 and the distal most tip surface of the electrode assembly 66 will be between approximately 0.2 mm and approximately 2 mm. In one embodiment, the distally projecting length L between the bottom surface 57 of the mesh 50 and the distal most tip surface of the electrode assembly 66 will be between approximately 0.5 mm and approximately 1 mm. This configuration will provide a reservoir 70 having a depth of at least L between the bottom surface 57 of the mesh 50 and the scalp surface 63 of the user 1 , as can be understood from Figure 5B.

[0066] In some embodiments, the electrodes 58 may be substantially flush with the bottom surface 57 of the mesh 50. Such an embodiment is depicted in Figure 5C, which depicts the electrodes 58 of the transdermal hair growth device in the same rearsectional view utilized in Figures 5B and 5C. As shown in Figure 5C, the electrodes 58 are substantially flush with the bottom surface of the mesh 50 and have no insulating elements 64 attached to the electrodes 58. As a result, the distal surfaces of the electrodes 58 are an exposed (i.e. , uninsulated) portion 59’ that contacts the reservoir 70. To maintain the offset between the electrodes 58 and the user’s scalp surface, thereby creating space for the reservoir 70 and preventing direct electrical contact between the electrodes 58 and the user’s scalp, dedicated insulating elements 64’ are offset from the electrodes 58. Such dedicated offset insulating elements 64’ are of an extended length L compared to the insulating tips 64 of the electrodes 58 of the embodiment depicted in Figures 5A and 5B, and the length of the dedicated offset insulating elements 64’ are sufficient to establish the space for the reservoir 70.

[0067] Thus, as can be understood from Figure 5C, depending on the embodiment, the distally projecting length L between the bottom surface 57 of the mesh 50 and the distal most tip surface of the insulating elements 64’ will be between approximately 0.2 mm and approximately 2 mm. In one embodiment, the distally projecting length L between the bottom surface 57 of the mesh 50 and the distal most tip surface of the insulating elements 64’ will be between approximately 0.5 mm and approximately 1 mm. This configuration will provide a reservoir 70 having a depth of at least L between the bottom surface 57 of the mesh 50 and the scalp surface 63 of the user 1 , as can be understood from Figure 5C.

[0068] While the height L of the reservoir 70 can be established and maintained by an electrode assembly 66 and/or some sort of structure 64’, 65 offset from the electrode assembly 66, as can be understood from Figures 5A-5H and the preceding discussion, in some embodiments the height L of the reservoir 50 is maintained via an intermediate layer 73. For example, as illustrated in Figures 5I, an intermediate layer 73 occupies the space between the scalp 63 and the bottom surface 57 of the mesh 50. In doing so, the intermediate layer 73 maintains the height L of the offset between the scalp 63 and bottom surface 57 of the mesh 50, resulting in the desirable reservoir 70 with a height L. As the intermediate layer 73 may be a porous or knit material, or alternatively a honeycomb or other cellular structure, located between the scalp 63 and bottom surface 57 of the mesh 50, the intermediate layer 73 can be saturated with the medicament solution 71. As a result, the reservoir 70 is substantially, if not completely, full of the medicament solution 71.

[0069] Thus, as can be understood from Figure 5I, depending on the embodiment, the thickness L of the intermediate layer 73 located between the bottom surface 57 of the mesh 50 and the scalp 63 will be between approximately 0.2 mm and approximately 2 mm. In one embodiment, the thickness L of the intermediate layer 73 located between the bottom surface 57 of the mesh 50 and the scalp 63 will be between approximately 0.5 mm and approximately 1 mm. This configuration will provide a reservoir 70 having a depth of at least L between the bottom surface 57 of the mesh 50 and the scalp surface 63 of the user 1 , as can be understood from Figure 5I.

[0070] In any of the previous embodiments, the depth L of the reservoir can be provided or supplemented by any user hair 2 present beneath the mesh 50.

[0071 ] In operation, the embodiments of Figures 5A-5C may perform similarly. However, the location, shape, and size of insulating elements 64, 64’ are different, as are the extent to which the electrodes 58 do or do not protrude below the bottom surface of the mesh 50. The electrodes 58 may be substantially flush with the bottom surface of the mesh 50, as shown with respect to the embodiment of Figure 5C. Alternatively, the electrodes 58 may extend beyond the bottom surface of the mesh 50 in a manner as shown in the embodiment of Figures 5A and 5B.

[0072] While the electrodes 58 of the embodiment of Figures 5A and 5B may distally terminate in the form of an insulating tip 64, in the embodiment depicted in Figure 50, the insulating elements 64’ may be configured as conical structures (depicted in Figure 5C) cylinders, rings, or any other shape, and these shapes are offset from the electrodes 58.

[0073] In some embodiments of the transdermal hair growth device 10, the mesh 50 may employ the electrode and insulating elements 64, 64’ of both embodiments depicted in Figures 5A-5C. For example, in such a combination embodiment, the mesh 50 may have employ the electrodes 58 and insulative tips 64 of the embodiment of Figures 5A and 5B at certain locations on the mesh 50 and at other locations on the mesh 50 may employ the electrodes and dedicated offset insulating elements 64’ of the embodiment of Figure 5C.

[0074] In some embodiments, the mesh 50 may be configured similarly to the embodiments shown in Figures 5A-5C, but without either the insulating tips 64 or the dedicated offset insulating elements 64’.

[0075] As noted above, the insulating element 64 may be a non-conductive coating or, in other embodiments, the insulating element may be made substantially or entirely from a vibrational element such as, for example, a piezoelectric vibrational element. As depicted in Figures 5D-5E, which are the same view as depicted in Figure 5A, in some embodiments, the piezoelectric vibrational element 65 may form part of an electrode assembly 66 including the electrode 58, the insulating element 64 and the piezoelectric vibrational element 65. By way of example and not limitation, in one embodiment the piezoelectric vibrational element 65 is embedded within the confines of the insulating element 64, as depicted in Figure 5D. Again, by way of example and not limitation, in one embodiment the piezoelectric vibrational element 65 forms the distal tip of the electrode assembly 66 with the insulating element 64 sandwiched between the electrode 58 and the piezoelectric vibrational element 65, as depicted in Figure 5E.

[0076] Of course, the piezoelectric vibrational element 65 of the electrode assembly 66 may be in other portions of the electrode assembly 66. By way of example and not limitation, in one embodiment the piezoelectric vibrational element 65 is embedded within the insulating element 64 and the electrode 58, forming a core of the electrode assembly 66, as depicted in Figure 5F.

[0077] As indicated in Figure 5G, in some embodiments, the piezoelectric vibrational element 65 may be spaced apart from the electrode 58 and insulation element 64.

[0078] As indicated in Figure 5H, in some embodiments, the piezoelectric vibrational element 65 may form a portion of, or all, the dedicated offset insulating elements 64’. Of course, in other embodiments, any one or more of the concepts disclosed above with respect to location of the piezoelectric vibrational element 65 being standalone (Figure 5G), part of the dedicated offset insulating elements 64’ (Figure 5H), or part of the electrode assembly 66 (Figures 5D-5F) can be employed, including any combination thereof. These concepts can even be combined to include the piezoelectric vibrational element 65 being present as parts of both the dedicated offset insulating element 64’ and of the piezoelectric vibrational element 65.

[0079] In one embodiment, piezoelectric vibrational element 65 can be structured to have direct vibrational contact with target tissue by the piezoelectric vibrational element 65 being part of, or forming, a geometric structural projection, whether that projection be part of a piezoelectric vibrational element 65 that is standalone (Figure 5G), part of a dedicated offset insulating element 64’ (Figure 5H), or part of an electrode assembly 66 (Figures 5D-5F). In certain embodiments, the geometric structural projection terminates in rounded or corrugated ends that contact the tissue to increase patient comfort and surface contact with the tissue. The rounded or corrugated ends can be an extension of the vibrational elements, or a can be made of a separate material. The ends can otherwise utilize short irregularities, non-sharp irregularities, projections, or lattices. Such structure improves the coupling of the vibratory component, decreases vibratory transmission problems, and converts many of the vertical mode oscillations into multimode coupling, which improves molecular transport across the electrode tissue boundary. Irregular or non-planar projected boundaries can be manufactured as a separate adherent layer against the piezo material, or it can be etched into the piezo material itself or deposited upon such.

[0080] In certain embodiments, the device 10 is designed so that when in use, the reservoir 70 defined between the bottom surface 57 of the mesh 50 and the scalp surface 63 of the user 1 is filled with a desired medicament solution 71 that is in electrical contact with an overlying dispersive single or multi-line array of iontophoretic electrode elements 58. As discussed above, in certain embodiments, the iontophoretic electrode elements 58 are structurally maintained in a spaced-apart relationship with the scalp surface 63 of the user 1 via either insulated contact between the electrode assembly 66 and the scalp surface 63 or by contact between the insulating elements 64’ and the scalp surface 63 so as to rely on conduction via the medicament solution 71 in the reservoir between the electrode 58 and the scalp surface 63.

[0081 ] In certain embodiments, there is no insulation layer where the piezoelectric vibrational element 65 and iontophoretic electrode 58 are combined into one by using DC offset or diode rectification of the piezo signal.

[0082] In certain embodiments, the iontophoresis electrodes 58 can operate off of a single signal or multiple independent signals. In a multi-signal embodiment, each iontophoresis electrode 58 can be separated and electrically isolated from the other electrode(s). Each of a plurality of current drivers forming part of a portion of the circuity 40 of the electronics module 30 can be coupled to each of their respective iontophoresis electrodes. In this way, each iontophoresis electrode has a separate electrical signal driven by a corresponding current driver.

[0083] In various embodiments, such as those of Figures 1 -51, the medication is pushed distally by a multi-line dispersion electrode 58 that can be photo-etched. This pushing of the medication can be optionally further pumped by the vibrational effects of the vibrational element 65.

[0084] In some embodiments where the vibration element 65 and the electrode 58 are part of a combined electrode assembly 66, the dispersion iontophoretic electrodes 58 can be directly photo-etched on the outer surface of the piezo electric elements 65 or can be photo-etched upon a malar film which is then adhered to the outer surface of the piezo electric element. In certain embodiments, the vibrational elements are piezoelectric elements coupled to the iontophoretic multi-line electrode as an integral assembly allowing for the direct coupling of the ultrasonic energy directly to the desired tissue, as shown in Figures 5D-5F. These integral assemblies move and vibrate the tissue in response to the changes in the vibrational piezoelectric elements. Electrical current can be applied to the plurality of iontophoresis electrodes to further drive the agent toward the targeted portion of the user’s scalp.

[0085] In some embodiments, the electromechanical coupling between the vibrational element and the iontophoretic electrode element jointly effect the penetration to a greater degree than any of the components separately. Such combined coupling of the aforementioned technologies working together and concurrently as part of the device 10 leads to delivery flux benefits that are greater and more efficacious than any of the technologies working alone or separately.

[0086] Figures 6A-6C are front perspective, front, and right views of another embodiment of the transdermal hair growth device 10’. Figures 7A and 7B are front perspective and rear perspective views of the transdermal hair growth device 10’ of Figures 6A-6C shown without the electronics unit 30. The device 10’ of Figures 6A-7B is similar to the transdermal hair growth device 10 of Figures 1 -5C in component makeup, configuration and operation, but is depicted without its cap for clarity purposes and has a different configuration as to the layout of the conductive pathways 56 and electrodes 58.

[0087] Figure 8 is a block diagram of the circuitry 40 of the transdermal devices 10, 10’ discussed above. As shown in the Figure 8, the circuitry 40 includes the electronics module 30 and the electrode network 51 . The electronics module 30 is in electrical communication with the electrode network 51 . The electronics module 30 controls and powers the functions of the electrode network 51 .

[0088] The electronics module 30 includes a battery 42, a controller 44, a current driver 46, and, depending on whether the device employs piezoelectric vibrational elements 65, an oscillation driver 47. The battery 42 is in electrical communication with the controller 44 and stores and provides operational energy to the rest of the circuitry 40.

[0089] The controller 44 is in electrical communication with the current driver 46 and the oscillation driver 47, where present. The controller 44 controls the operations of the drivers 46, 47.

[0090] The current driver 46 is in electrical communication with the electrodes 58 of the electrode network 51 and powers and controls the function of the electrodes 58. Where the embodiment employs piezoelectric vibrational elements 65, the oscillation driver 47 is in electrical communication with the vibrational elements 65 of the electrode network 51 and powers and controls the function of the vibrational elements 65. [0091 ] As indicated in Figure 8, in one embodiment, the controller 44 is part of the device 10. In other embodiments, the controller 44 is a separate component that is communicatively coupled (e.g., hard wired or wirelessly) to the current driver 46 and oscillation driver 47. In certain embodiments, the controller can be configured to control timing and delivery of therapeutic substances across tissue.

[0092] The operation of the transdermal hair growth devices 10, 10’ described above are based on underlying principles of iontophoresis with technical improvements allowing for controlled dispersion and prevention of skin irritation and “tunneling” which have afflicted existing iontophoresis devices.

[0093] In standard iontophoresis a pair of electrodes is used. One electrode of the pair of electrodes is the active electrode (usually positive polarity) and the other electrode of the pair of electrodes is a counter electrode (usually negative polarity).

[0094] In contrast to standard iontophoresis systems, the above-described embodiments of the present invention of Figures 1-7B include a battery supplied control circuit 40 driving 12-48 or more separate channels, as discussed above. A plurality (more than one) of electrode pairs is employed in order to cover a wider anatomical area allowing for the limiting and control of the current flow through each pair of electrodes. Each pair of channels within the multichannel embodiments is controlled and modulated by a current driver including a common embedded CPU driven control 40 that modulates and determines the clinically appropriate current flow through each subservient pair of iontophoresis electrodes 58.

[0095] In some embodiments, each channel supplies an electrode 50 that contacts 1 to 2 cm2 of skin and is current controlled to drive for less than .6 mA per channel. Through experimentation, it was determined that by maintaining current flow below 1 mA flux /cm2 of electrode contact that skin irritation at the site of contact seldom occurred. In some embodiments, the current flow capacity of each channel pair is limited to 0.8 mA or less.

[0096] To further enhance the medicament penetration characteristics of the device 10, 10’, the device can be integrated with piezoelectric elements and an associated driver to create localized ultrasonic dispersion/enhancement in the scalp that further enhances the efficacy of the multichannel iontosonic/ionosonic technology described herein. For example, such piezoelectric elements may be located on one or more (including, for example, each and every) active electrode. Such piezoelectric elements may be part of, or supported on, the associated electrodes. Alternatively, or additionally, such piezoelectric elements may be separate and spaced apart from the associated electrodes. The ultrasonic energy has been found to be synergistic with the multichannel dispersive iontophoresis technology described herein.

[0097] In some embodiments, battery and electronic control may be retained within the device 10 or via a remote control. The device 10 may also be configured so as to allow for the periodical changing of the location/configuration of the contact electrodes as well as headwear structure for reasons such as, for example, wear comfort and/or aesthetic choices. In some embodiments, changes or modifications to the device 10 may also allow for relocation of the battery and/or electronic unit. The device 10 also may be configured to allow for recharging of the battery, activation via a switch, and readouts, lights and/or sounds indicating proper placement and/or function.

[0098] As discussed above, in some embodiments, the electrodes 58 are interposed in a layer of non-conductive polymer open cell mesh 50 with a hydrophilic and/or hydrophobic surface depending on the desired intended formulation between the electrodes and skin. In some embodiments, the mesh 50 is a combination of both hydrophilic and hydrophobic polymer meshes to accommodate the use of diverse agents with diverse solubilities in aqueous or oily solvents.

[0099] In some embodiments and as discussed above with respect to Figures 5A-5C, the mesh 50 and partial hair fibers 2 function as an integrated medication reservoir 70.

[00100] With all the devices 10, 10’ disclosed herein, the electro kinetic delivery of the medicament is sufficient to provide a substantial treatment improvement to the hair of the patient but is still so limited that any systemic absorption is sufficiently minimal as to be considered negligible and inconsequential. Thus, this approach is able to deliver a therapeutic dose of exemplary medication such as finasteride directly to the hair root without invoking systemic side effects that limit its use. Further, the devices 10, 10’ described herein are relatively molecule agnostic and will accelerate the penetration of variety of molecules directly to the hair root.

[00101 ] When a therapeutic substance dissolves in water or another solvent, the therapeutic substance essentially dissociates into its ionic components. In solution, each ion is surrounded by a cloud of its polar solvent molecules and maintained in its ion dissociated form. When an electric field is introduced across such solution, a forced migration of such molecules results with movement toward the target tissue via the herein disclosed devices and electrode configurations. Such enhanced movement created by the controlled and dispersive electric field is a benefit provided by the herein disclosed devices 10, 10’ and associated methods. In essence, the medication molecule becomes the current carrier through the interposed thin layer 70 (with hair as part of this layer 70) that functions as medication reservoir 70.

[00102] Further optimization of medicament penetration can be achieved with composition modification regarding PH, buffering, competing ionization and related factors. For example, oil-based materials may benefit from the addition of DMSO (Dimethyl sulfoxide).

[00103] Figure 9 outlines a possible treatment method employing the transdermal device 10. As indicated in Figure 9, a method of using the transdermal hair growth acceleration device 10, 10’ may begin by washing the user’s hair and scalp to remove debris and oils prior to application of the medicament solution 71 [Block 100], Besides cleaning the user’s hair and scalp to more readily accepts the following medicament solution, the washing will saturate the hair 2 with water, substantially increasing the electrical conductivity of the hair.

[00104] While the user’s hair 2 is still wet, the desired approved topical medicament solution 71 is applied to the hair 2 and scalp 63 of the user 1 [Block 110], The medicament solution 71 may be applied to the hair 2 in form of a shampoo that is not rinsed away prior to application of the cap 20 to the user’s scalp, the medicament solution 71 staying “wet” or in liquid form on the user’s scalp beneath the cap 20.

[00105] After the application of the medicament, the transdermal device 10, 10’ is positioned on the scalp 63 of the user 1 , as can be understood from Figures 1 -3B and 6A-7B [Block 120], In some embodiments, the dispersive electrodes 58 are applied to the scalp as an anatomical cap 20, and this cap 20 is retained in place by straps 22, as can be understood from Figure 1 .

[00106] In doing so, the active electrodes 54 are anatomically dispersed at the front hairline, crown and/or other regions of the scalp where hair deficiency occurs, and the counter electrodes 52 extend to the back side of the forehead, back of neck, jawline, and/or other areas not being treated for hair deficiency, as depicted in Figures 2-3B, for example [Block 130], Thus, the dispersive electrodes 54 are in contact with the hair loss areas, and the associated counter electrodes 52 are in direct contact with areas that are generally free of hair.

[00107] Further, in applying the transdermal device 10, 10’ to the user’s scalp, the reservoir 70 between the scalp surface 63 and the bottom surface 57 of the mesh 50 is established on account of the spacing function of certain structural features, such as the electrode assemblies 66, dedicated offset insulating elements 64’, or the intermediate layer 73 made of a porous or knit material, or alternatively a honeycomb or other cellular structure [Block 140], Specifically, as can be understood from Figures 5A- 5C, the distal tips of such certain structural features 66, 64’ abut against the scalp surface 63 and/or hair 2 of the user 1 . Since the distal tips of the certain structural features 66, 64’ are distally spaced apart from the bottom surface 57 of the mesh 50, these distal tips maintain the bottom surface 57 of the mesh 50 spaced-apart from the scalp surface 53, thereby defining the medicament reservoir 70. In a similar fashion, as depicted in Figure 5I, the intermediate layer 73 maintains the bottom surface 57 of the mesh 50 spaced-apart from the scalp surface 53, thereby defining the medicament reservoir 70.

[00108] The active electrodes 54 will utilize the reservoir 70 generally occupied with the medicament solution 71 to establish electrical conductivity between the active electrodes 54 and the user’s scalp 63, as can be understood by Figures 5A- 5C, for example [Block 150], The counter electrodes 52 can be provided with contact hydrogel to facilitate their electrical conductivity with the user’s skin 63. On account of the active electrodes 54 being spaced apart from the scalp 63 by the height L of the reservoir 70, as shown in Figures 5B, 5C and 51, the current is more evenly dispersed across the treatment area and current tunnelling and its associated tissue damage is avoided.

[00109] An occlusive cap may be applied over the transdermal device 10, 10’ to reduce medicament evaporation and maintain an adequate volume of medicament solution 71 within the reservoir 70 to facilitate the electrical conductivity between the active electrodes 54 and user’s skin 63 [Block 160], This occlusive cap may be an elastomer occlusive cap akin to a swimming cap. While the cap 20 of the transdermal device 10, 10’ in of itself provides moisture occlusion to prevent drying or crystallization of the medicament solution 71 being delivered via the transdermal device 10, 10’, the addition of the occlusive cap worn over the cap 20 of transdermal device 10, 10’ further increases the moisture occlusion aspects over what is offered via use of the cap 20 alone.

[00110] Once the transdermal device 10, 10’ with its electrodes 58 and retaining cap 20 are applied to the scalp 63 of the user 1 as depicted in Figures 1 and 2, the electronics 40 of the device 10, 10’ can be activated. Upon activation of the electronics 40, the active electrodes 54, working in programmed pairing with associated counter electrodes 52, drive the medication slowly into the scalp 63 during a treatment period [Block 170], Depending on the embodiment, a current setting of 0.1 mA to 0.2 mA per channel can be utilized. In other embodiments, any of the other current settings described above can be employed.

[00111 ] Because the hair 2 is pre-saturated due to the washing of Block 100, again saturated by application of the medicament solution 71 of Block 110, and then protected against evaporation by the cap 20 and the additional occlusive cap, the hair 2 is saturated by water and medicament solution. As a result, the electrical conductivity of the hair 2 is substantially increased over the conductivity of dry hair. As a result, the highly conductive saturated hair and its roots get focused administration of the medicament solution due to the focused transportation of the administered current over the saturated hair, thereby providing a focused iontophoretic process that drives the medicament to the place most needed by the treatment, that place being the hair roots.

[00112] In one embodiment, upon activation of the electronics 40, the electrodes 58 are driven at a slow ramp up of current over an extended period of time so the user does not feel any discomfort or anxiety from current being administer to their scalp. For example, in one embodiment, during the ramp up period, the current administered by the active electrodes to the scalp gradually increases from 0 mA/channel to 0.4 mA/channel or 0.6 mA/channel over the course of two minutes.

[00113] In one embodiment, once the transdermal device 10 is fully operating and administering current to the scalp according to preprogrammed therapy protocols, the active electrodes of one or more channels may be periodically driven so as to administer a pulsed current to the scalp so the user will know the transdermal device 10 is operating.

[00114] The transdermal device 10, 10’ can be programmed for the appropriate operational period, which may be, for example, approximately 4-6 hours of active delivery into the scalp of a low current that drives the active medicament molecule that was applied to the hair and scalp prior placement of the transdermal device 10, 10’ and occlusive cap onto the user’s scalp. Depending on the treatment protocol, the transdermal device 10, 10’ may be worn for several hours a few times a week or during sleep.

[00115] The transdermal device 10, 10’ can also be programmed for a selected magnitude of current.

[00116] It should be understood from the foregoing that, while particular aspects have been illustrated and described, various modifications can be made thereto without departing from the spirit and scope of the invention as will be apparent to those skilled in the art. Such changes and modifications are within the scope and teachings of this invention as defined in the claims appended hereto.

[00117] As used herein, each of the following terms has the meaning associated with it in this section. [00118] The articles “a” and “an” are used herein to refer to one or to more than one (i.e. , to at least one) of the grammatical object of the article. By way of example, “an element” means one element or more than one element.

[00119] “About” and “approximately” and variations thereof as used herein when referring to a measurable value such as an amount, a temporal duration, and the like, is meant to encompass variations of ±20%, ±10%, ±5%, ±1 %, and ±0.1 % from the specified value, as such variations are appropriate.

[00120] Ranges: throughout this disclosure, various aspects of the invention can be presented in a range format. The description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the invention. Where appropriate, the description of a range should be considered to have specifically disclosed all the possible subranges as well as individual numerical values within that range. For example, description of a range such as from 1 to 6 should be considered to have specifically disclosed subranges such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6 etc., as well as individual numbers within that range, for example, 1 , 2, 2.7, 3, 4, 5, 5.3, and 6. This applies regardless of the breadth of the range.

Claims

CLAIMS What is claimed is:

1 . A transdermal hair growth acceleration device configured to be applied to a head of a user to drive a medicament solution into a scalp of the user via iontophoresis, the device comprising; an electrode network of multiple channels including active electrodes and counter electrodes, each counter electrode paired with an associated active electrode; a substrate supporting the electrode network and configured to be worn on the head; structural features protruding distally from a bottom surface of the substrate, wherein when the substrate is worn on the head, the structural features space the bottom surface from the scalp of the user to create a reservoir for the medicament solution between the bottom surface and the scalp; and an electronics module including a controller and a current driver in communication with the controller and the active electrodes of the electrode network, wherein the controller causes the current driver to drive the active electrodes to deliver a current to the scalp via the medicament solution in the reservoir.

2. The transdermal hair growth acceleration device of claim 1 , wherein each channel supplies an electrode that contacts approximately 1 cm² to approximately 2 cm² of the scalp.

3. The transdermal hair growth acceleration device of claim 1 , wherein the controller causes the current driver to drive the active electrodes at a current flow of less than 1 mA flux /cm² of electrode contact with the scalp per channel.

4. The transdermal hair growth acceleration device of claim 1 , wherein the controller causes the current driver to drive the active electrodes at a current flow of less than 0.8 mA flux /cm² of electrode contact with the scalp per channel.

5. The transdermal hair growth acceleration device of claim 1 , wherein the controller causes the current driver to drive the active electrodes at a current flow of less than 0.6 mA flux /cm² of electrode contact with the scalp per channel.

6. The transdermal hair growth acceleration device of claim 1 , wherein the electrode network further includes vibrational elements, and the electronics module includes an oscillation driver in communication with the controller and the vibration elements, wherein the controller causes the oscillation driver to drive the vibration elements to deliver a vibration to the scalp.

7. The transdermal hair growth acceleration device of claim 1 , wherein the structural features include at least one of an electrode assembly, a dedicated insulating element offset from the active electrodes, or an intermediate layer including a porous material, knit material, a honeycomb structure, or a cellular structure.

8. The transdermal hair growth acceleration device of claim 7, wherein the electrode assembly includes an electrically insulative distal tip.

9. The transdermal hair growth acceleration device of claim 1 , wherein, upon being activated, the active electrodes gradually increase a level of current administration over an extended period until reaching a level of current appropriate for treatment.

10. The transdermal hair growth acceleration device of claim 1 , wherein an active electrode on at least one channel has its current pulsed periodically to signal to the user

11 . The transdermal hair growth acceleration device of claim 1 , wherein the resulting reservoir has a height of between approximately 0.2 mm and approximately 2 mm.

12. The transdermal hair growth acceleration device of claim 1 , wherein the resulting reservoir has a height of between approximately 0.5 mm and approximately 1 mm.

13. A method of administering a medicament solution to a scalp of a user, wherein the medicament solution encourages hair growth in areas of the scalp suffering from hair loss, the method comprising; applying a medicament solution to the scalp; applying a transdermal hair growth acceleration device to a head of a user and over the medicament solution, the device comprising an electrode network, a substrate, structural features and an electronics module, the electrode network being of multiple channels and including active electrodes and counter electrodes, each counter electrode paired with an associated active electrode, the substrate supporting the electrode network and configured to be worn on the head, the structural features protruding distally from a bottom surface of the substrate, the electronics module including a controller and a current driver in communication with the controller and the active electrodes of the electrode network; positioning the substrate on the head such that the structural features space the bottom surface from the scalp of the user to create a reservoir for the medicament solution between the bottom surface and the scalp; and using the controller to cause the current driver to drive the active electrodes to deliver a current to the scalp via the medicament solution in the reservoir, thereby driving the medicament solution into a scalp of the user via iontophoresis.

14. The method of claim 13, wherein each channel supplies an electrode that contacts approximately 1 cm² to approximately 2 cm² of the scalp.

15. The method of claim 13, wherein the controller causes the current driver to drive the active electrodes at a current flow of less than 1 mA flux /cm² of electrode contact with the scalp per channel.

16. The method of claim 13, wherein the controller causes the current driver to drive the active electrodes at a current flow of less than 0.8 mA flux /cm² of electrode contact with the scalp per channel.

17. The method of claim 13, wherein the controller causes the current driver to drive the active electrodes at a current flow of less than 0.6 mA flux /cm² of electrode contact with the scalp per channel.

18. The method of claim 13, wherein the electrode network further includes vibrational elements, and the electronics module includes an oscillation driver in communication with the controller and the vibration elements, wherein the controller causes the oscillation driver to drive the vibration elements to deliver a vibration to the scalp.

19. The method of claim 13, wherein the structural features include at least one of an electrode assembly, a dedicated insulating element offset from the active electrodes, or an intermediate layer including a porous material, knit material, a honeycomb structure, or a cellular structure.

20. The method of claim 19, wherein the electrode assembly includes an electrically insulative distal tip.

21 . The method of claim 13, wherein the reservoir has a height of between approximately 0.2 mm and approximately 2 mm.

22. The method of claim 13, wherein the reservoir has a height of between approximately 0.5 mm and approximately 1 mm.