Unitary enhanced jet spray dermal treatment handpiece

Abstract

A multi-technology dermal treatment integral handheld device includes: a spray delivery handheld device having an elongated housing terminated in one or more nozzles for guiding a therapeutic spray toward the subject's skin along an axis at a desired spray application distance from the subject's skin; and one or more symbiotic treatment handheld device elements terminated in an operating end member having a dermal contact surface for delivering a therapeutic agent to the skin, the therapeutic agent being symbiotic with the treatment provided by the therapeutic spray, wherein the operating end member and the contact surface are laterally spaced apart from the axis, and wherein the operating end member and the contact surface are axially displaced away from one or more nozzles by a distance determined to limit the proximity of one or more nozzles to the subject's skin to not less than the desired spray application distance.

Description

Technical Field

[0001] The case involves, in its entirety, a handheld device for dermal drug delivery of therapeutic agents. Prior Technology

[0002] Various techniques for therapeutic treatment of the skin of human subjects are well known in the art. One such skin care technique is described in the International Publication No. WO 2005 / 065032 of the applicant’s “A High Velocity Liquid-Gas Mist Tissue Abrasion Device”, the contents of which are incorporated herein by reference.

[0003] The aforementioned reference document discloses a dermal abrasion device comprising a high-speed liquid-gas jet spray formed from droplets of a therapeutic agent in a liquid suspension. The spray is applied as a flowing mist to the skin of a subject and can be used for transdermal delivery of a therapeutic agent to the skin.

[0004] More specifically, and referring to prior art Figures 1A-1C, WO 2005 / 065032, which is referenced above, discloses an apparatus for applying a high-speed liquid-gas mist to tissue, the general component designation of which is 1000 (Figure 1A). The overall apparatus 1000 includes a sealed housing portion 1020 having a generally tubular configuration and having a proximal end and a distal end, the component designations of which are 1040 and 1060, respectively. The housing portion 1020 is formed to withstand extremely high pressures, typically up to 100 PSI. A gas inlet port 1080 and a liquid inlet port 1100 are located at the proximal end 1040, while a mist delivery nozzle, generally designated 1120, is arranged at the distal end 1060.

[0005] Referring now to Figures 1B and 1C, a schematic cross-sectional view of the nozzle arrangement 1120 of device 1000 can be seen. The nozzle arrangement 1120 includes a gas discharge nozzle, generally denoted by 1140. A liquid discharge nozzle 1160 is arranged generally concentrically within the gas discharge nozzle 1140. A liquid inlet port 1100 is in fluid communication with the liquid discharge nozzle 1160 through a liquid connecting pipe 1180, which is generally concentrically arranged within the tubular housing portion 1020.

[0006] Pressurized gas supplied from a pressurized gas source (not shown) enters the device 1000 through gas inlet port 1080 and, as indicated by arrow 1340, flows along and within the tubular housing portion 1020 to be discharged through gas discharge nozzle 1140. Gas discharge nozzle 1140 is generally configured to have a converging portion 1200, a throat 1220, and a diverging discharge portion 1240 in flow sequence. As indicated by arrow 1260, the pressurized gas discharged from nozzle 1140 undergoes a rapid and significant decrease in pressure to atmospheric pressure, and a significant acceleration from subsonic to supersonic speeds, particularly towards supersonic speeds. Gas discharge nozzle 1140 is configured such that the discharged gas has a cone angle of less than 10 degrees, i.e., providing a generally parallel airflow.

[0007] Liquid from a pressurized liquid source (not shown) enters the device 1000 through the liquid inlet port 1100 and flows through the liquid connecting pipe 1180 as indicated by arrow 1320. Conversely, at the distal end 1060, liquid is discharged into the exhaust gas flow 1260 through the opening 1280 in the distal end of the liquid discharge nozzle 1160, the liquid flow being indicated by arrow 1300.

[0008] Those skilled in the art will understand that when pressurized exhaust gas is discharged from gas exhaust nozzle 1140 to the atmosphere at 1260, it experiences a rapid pressure drop to atmospheric pressure. This sudden pressure drop causes the exhaust gas velocity to increase dramatically, approaching or even exceeding the speed of sound, and generating a shock wave. The effect of the shock wave is to atomize the liquid discharged from liquid exhaust nozzle 1160 into an airflow as droplet mist 1300, thereby achieving a relatively narrow droplet jet in the high-speed airflow 1260.

[0009] Furthermore, for example, due to the relatively high gas pressure of approximately 689.5 kPa (100 psi) and the relatively low liquid pressure of approximately 13.8 kPa (2 psi), and the relatively large inner diameter of the gas discharge nozzle 1140 (approximately 0.8 mm) compared to the small inner diameter of the liquid discharge nozzle 1300 (approximately 0.09 mm), the ratio of liquid flow rate to gas flow rate is very low.

[0010] Various supplementary technologies are known for their beneficial effects in the field of skin care.

[0011] For example, electroremoval uses electrical pulses to increase cell permeability and demonstrate the deep penetration of skin care products. A detailed discussion of electroremoval can be found in the article Front. Bioeng. Biotechnol., January 16, 2023, Chapter Cell and Gene Therapy, Volume 10–2022. An electroremoval device for dermal therapy is also disclosed in Broderick et al., USP 11291836.

[0012] Ultrasound therapy (also known as ultrasound transdermal and ultrasound delivery) is known for its ability to assist in the transdermal administration of therapeutic agents, see, for example, https: / / en.wikipedia.org / wiki / Phonophoresis. Summary of the Invention

[0013] The present invention aims to provide an enhanced spray-type leather delivery handpiece.

[0014] Therefore, according to one embodiment, a multi-technology dermal treatment integral handheld device is provided, comprising:

[0015] A spray delivery handheld device having an elongated housing terminated in one or more nozzles for guiding a therapeutic spray toward the subject's skin along an axis at a desired spray application distance from the subject's skin; and

[0016] One or more symbiotic therapeutic handheld elements, terminated at an operating end member having a dermal contact surface for delivering a therapeutic agent to the skin, the therapeutic agent being symbiotic with a therapy provided by a therapeutic spray.

[0017] The operating end component and the contact surface are laterally spaced from the axis.

[0018] Furthermore, the operating end component and the contact surface are axially displaced away from one or more nozzles by a distance determined to limit the proximity of one or more nozzles to the subject's skin to no less than the desired spray application distance.

[0019] In another embodiment, the operating ends of one or more symbiotic therapeutic handheld elements can be adjusted along an axis relative to one or more nozzles, thereby correspondingly adjusting the spray application distance.

[0020] In another embodiment, one or more symbiotic therapeutic handheld components include a first symbiotic therapeutic handheld component and a second symbiotic therapeutic handheld component.

[0021] In another embodiment, the operating end member and the leather contact surface are bent and mounted so as to remain in a plane transverse to the axis.

[0022] In another embodiment, the leather touch surface is arc-shaped and mounted such that its center of curvature intersects the axis in a plane orthogonal to the axis.

[0023] According to another embodiment, one or more co-existing therapeutic handheld components further include:

[0024] A cylindrical sheath having a proximal end and a distal end, the cylindrical sheath being configured to at least partially surround the housing of a spray delivery handpiece, such that one or more nozzles of the spray delivery handpiece protrude through the distal end of the cylindrical sheath; and

[0025] A support member for mounting the operating end component to the distal end of a cylindrical sheath to position the contact surface relative to one or more nozzles at a distance equal to the desired spray application distance.

[0026] According to another embodiment, the housing of the jet spray delivery handpiece has a proximal end and a distal end, wherein the jet spray delivery handpiece further includes a jet spray delivery head formed at the distal end of the housing and terminated in one or more nozzles, the delivery head being connected to a source of a liquid suspension of a therapeutic agent and a source of pressurized gas to selectively combine and supply the liquid suspension and pressurized gas to the jet spray delivery head.

[0027] In another embodiment, the operating end member is powered by electricity, and one or more symbiotic therapeutic handpiece elements include an electrical conduction element for supplying electricity from the power source to the operating end member.

[0028] According to another embodiment, the jet spray delivery handheld device includes a liquid supply tube positioned within a housing for supplying a liquid suspension of a therapeutic agent, wherein the housing is operable to deliver pressurized gas to a delivery head to combine the liquid and pressurized gas into a jet spray at the delivery head for delivery through one or more nozzles;

[0029] Furthermore, the cylindrical sheath is associated with an electrical conductor for supplying power to the operating end components.

[0030] According to another embodiment, the liquid supply tube is terminated at its proximal end to a liquid connector leading to an external liquid source, the sealing housing is terminated at its proximal end to a gas connector leading to an external pressurized gas source, and the electrical conductor is terminated at its proximal end to an electrical connector leading to an external power source.

[0031] The handheld component also includes a hollow connector, which connects to the proximal end of the cylindrical sheath for accommodating liquid connectors, gas connectors, and electrical connectors.

[0032] In another embodiment, the connector and the cylindrical sheath are coupled together via a clamp.

[0033] In another embodiment, one or more co-existing therapeutic handheld components are electro-removal elements, and the operating end component is an electro-removal probe.

[0034] In another embodiment, one or more co-existing therapeutic handheld components are ultrasonic elements, and the operating end component is an ultrasonic transducer.

[0035] In another embodiment, the first symbiotic therapeutic handheld element is an electro-removal element and its operating end component is an electro-removal probe; and the second symbiotic therapeutic handheld element is an ultrasonic element and its operating end component is an ultrasonic transducer.

[0036] Alternatively, a dermal treatment handpiece is provided, comprising:

[0037] A spray delivery handheld device having an elongated housing terminating in one or more nozzles for guiding a therapeutic spray toward the subject's skin along an axis at a desired spray application distance from the subject's skin; and

[0038] An adjustable rigid spacer element, mounted on a housing, is used to adjustably limit the proximity of one or more nozzles to the subject's skin during treatment to a selected spray application distance. The spacer element includes:

[0039] A curved dermal contact portion, extending axially beyond one or more nozzles, to allow a delivery head configured to remain in contact with the subject's skin during treatment to hang suspended; and

[0040] The mounting portion is configured to mount the leather-touch portion onto the housing at a known distance from one or more nozzles, thereby determining the spray application distance.

[0041] Therefore, we offer an integrated, multi-technology dermal treatment handheld device, including:

[0042] A. An integral spray delivery handheld device having a sealed, elongated housing having an axis of symmetry and terminating at a delivery head having one or more therapeutic spray nozzles for guiding a therapeutic spray toward the subject's skin along the axis at a desired spray application distance from the subject's skin, wherein each therapeutic spray nozzle includes;

[0043] (i) One or more gas discharge nozzles aligned with an axis of symmetry, for receiving a high-pressure gas flow and delivering the gas flow into the atmosphere, thereby generating a shock wave upon exiting the one or more gas discharge nozzles, the one or more gas discharge nozzles having an inner diameter; and

[0044] (ii) One or more linear liquid discharge nozzles having a longitudinal axis extending through one or more gas discharge nozzles coaxial with it, and having an outer diameter smaller than the inner diameter of the one or more gas discharge nozzles, the one or more linear liquid discharge nozzles having openings for discharging a therapeutic liquid flow into a pressurized gas flow, thereby exposing the therapeutic liquid flow to a shock wave to atomize the liquid into microdroplets, the atomized liquid combining with the gas flow to generate a high-speed, concentrated therapeutic microdroplet jet spray along the axis, the microdroplets having a predetermined quality to facilitate transdermal infusion to the subject at a predetermined spray application distance from the subject, and

[0045] B. One or more electrically operable symbiotic therapeutic handheld components, each terminated in an operating end member having a dermal contact surface for delivering treatment to the skin, the treatment being symbiotic with treatment provided by a therapeutic spray.

[0046] The operating end component and the contact surface are laterally spaced from the axis, and

[0047] C. A mechanism for positioning the operating end component and the contact surface outside the therapeutic spray nozzle at a spray application distance, the distance being within a predetermined range.

[0048] definition

[0049] In the following disclosure, the term "far side" refers to the portion of the disclosed device or handheld device that is furthest from the user operating the device, i.e., closest to the spray delivery end of the device. The term "proximal side" refers to the portion of the device or handheld device that is closest to or most intimately connected to the user, i.e., furthest from the spray delivery end of the device.

[0050] The term "operating medium" is used collectively as the flow of gas, liquid, and electricity required for the operation of the integrated handheld device, including the contents of this case. Simple Explanation of the Diagram

[0051] The invention will be more fully understood and appreciated from the detailed description taken in conjunction with the accompanying drawings, in which:

[0052] Figure 1A is a schematic side view of the prior art wear device according to WO 2005 / 065032;

[0053] Figures 1B and 1C are respectively enlarged schematic diagrams and graphic representations of the prior art shown in Figure 1A;

[0054] Figure 2A illustrates a multi-technology dermal treatment integrated handheld device constructed and operated according to an embodiment of the present invention;

[0055] Figure 2B is an enlarged schematic diagram showing the operation of the multi-technology dermal treatment monolithic handheld device seen in Figure 2A, wherein the illustrated operating end component is exemplified as an electrocautery probe;

[0056] Figure 2C is a schematic top view of the operating end component in the position shown in Figure 2B;

[0057] Figure 3A is an exploded view of the handheld component of Figures 2A and 2B according to an embodiment before assembly;

[0058] Figures 3B and 3C are views of the handheld component from Figure 3A after assembly;

[0059] Figure 4 is a slender cross-sectional view of the handheld component;

[0060] Figure 5A is an enlarged partial sectional side view of the connector illustrated in Figure 4;

[0061] Figure 5B is a perspective view of the connector shown in Figure 5A;

[0062] Figure 6 is a view similar to Figures 5A and 5B, but with a snap-fit ​​connector;

[0063] Figure 7A is an enlarged view of the operating end of the handheld device illustrated above according to one embodiment, wherein the probe is slidably adjustable relative to the illustrated nozzle;

[0064] Figures 7B and 7C are cross-sectional views of Figure 7A, showing the probe in the extended and retracted positions relative to the nozzle, respectively.

[0065] Figures 8A and 8B are enlarged views of the operating end of the handheld component illustrated above according to the second embodiment, in the extended and retracted positions, respectively, wherein the probe can be adjusted relative to the illustrated nozzle by means of a thread;

[0066] Figure 9 is a perspective view of an integral handheld device similar to the integral handheld device in Figures 2A to 8B, but the operating end component illustrated therein is exemplified as a ring-shaped ultrasonic transducer;

[0067] Figure 10 is similar to Figure 9, but the transducer in Figure 10 is U-shaped;

[0068] Figure 11 is a perspective view of an integrated handheld device similar to the integrated handheld devices in Figures 2A to 10, but in which the electrical bleeder probe and ultrasonic transducer are incorporated into the integrated operating end component;

[0069] Figure 12A is an enlarged view of the end portion of Figure 11;

[0070] Figure 12B is similar to Figure 12A, but the integral operating end member is shown in cross-section; and

[0071] Figure 13 is an enlarged schematic diagram showing the operation of the spray handheld device, which is equipped with an interval probe to accurately control the distance between the nozzle and the subject's skin. Implementation

[0072] Referring now to Figure 2A, the present invention relates to a multi-technology dermal treatment system 10 for enhancing the delivery of therapeutic substances to a subject through the dermis. System 10 employs one or more complementary dermal treatment systems, such as those manufactured and sold by Tav-Tech Ltd. of Yehud, Israel, and available at https: / / jetpeel.com, for treating a subject using a multi-technology dermal treatment monolithic handpiece 100, in symbiotic combination with a dermal jet spray treatment system. Incorporating one or more technologies, along with the jet spray technology described herein, into the monolithic handpiece increases the porosity of the dermis to enhance jet spray treatment in ways not previously available. As exemplified below, such symbiotic or complementary systems may use electro-cleansing and / or ultrasound technologies, but other technologies may also be used as alternatives to or complements to these technologies.

[0073] Referring now to Figures 2B through 4, as mentioned, the handheld component 100 incorporates the jet spray delivery handheld component 200 and the symbiotic therapeutic element 300, which are integrated into a single handheld dermal treatment tool. The therapeutic element 300 extends generally along and wraps around the jet spray delivery handheld component 200 and terminates in an operating end member 320, which is generally considered to be coaxial with and protrude beyond the nozzle 230 of the handheld component 200, such that in use the operating end member substantially defines and isolates the treatment area on the subject. In this illustrative embodiment, element 300 is an electro-removal element, but other types of therapeutic techniques symbiotic with the jet spray treatment provided by the handheld component 200 are also contemplated. Thus, by way of non-limiting example only, as shown and described below in conjunction with Figures 9 through 12B, an alternative or additional symbiotic technique is ultrasound.

[0074] Furthermore, as seen in the accompanying drawings, the end member 320 and the leather-touch surface 323 are curved and reside in a plane schematically shown at 241 (Figures 1B and 3B) that is transverse to the axis 240 (generally orthogonal to the axis).

[0075] Referring now specifically to Figure 2A, system 10 has an operating system 12, which may be substantially similar to any of the operating units provided with the applicant's JetPro™, JetProDuo™, JetProToGo™, or MyJet™ products. Operating system 12 includes sources of various operating media required to operate the integral handheld device of the present invention, and therefore includes an air compressor 14 for supplying compressed air to the handheld device 200 via air pipe 16 to deliver the spray.

[0076] The power supply unit 20 incorporates the necessary hardware and software required to operate the operating end component 320, which is embodied in (i) the electrically censored probe 320 shown and described below in conjunction with Figures 2B to 8B; (ii) the ultrasonic transducers 420 and 420' shown and described below in conjunction with Figures 9 and 10 respectively; (iii) the combination of probe 320 and transducer 420 shown and described below as a combined component 520 in conjunction with Figures 11 to 12B; or (iv) any other technology associated with the jet spray technology described herein. Such hardware and software required to operate both the electrically censored probe and the ultrasonic therapy or ultrasonic transducer are well known in the art and therefore will not be described in detail herein.

[0077] One or more therapeutic fluids, such as those advertised as JetCare by TavTech™ at https: / / jetpeel.com / jetcare / , are available from various fluid containers 22 via fluid fitting 24. A wire 26 is also provided for conducting electricity from power source 20 to an additional symbiotic subsystem incorporated into the handheld device 100 as needed. Air tubing 16, fluid fitting 24, and wire 26 are all encased in a protective molded umbilical hose 28, which is connected to the handheld device 100 via connector 120. A control panel, schematically illustrated in the accompanying drawings and labeled 30, is also provided.

[0078] Referring now to Figure 3A, which illustrates the handheld part 100 before assembly, the jet spray delivery handheld part 200 has an elongated sealed housing 202 with proximal and distal ends, respectively designated 210 and 212. The distal end 212 forms a delivery head 220 with one or more nozzles 230 thereon. The jet spray delivery handheld part 200 can be as detailed in the applicant's European Patent No. 1883447, as described in the prior art above, as described on the applicant's website https: / / tav-tech.com / jet-technology; or any suitable product from Tav-Tech Ltd employing its liquid mist / jet spray technology. Therefore, the precise internal construction and operation of the handheld part for obtaining the cited jet spray are well known in the art and are therefore not illustrated or described herein.

[0079] Nozzle 230 operates to eject a therapeutic spray 242 toward the subject's skin 110 (as seen in Figure 2B). The spray is guided along axis 240 at a predetermined spray application distance "z" (typically in the range of 5-15 mm). Axis 240 is generally the longitudinal axis of both the spray delivery handpiece 200 and the symbiotic therapeutic handpiece element 300.

[0080] As is well known in the art, therapeutic sprays are generated by combining an inflow of a liquid suspension of a therapeutic agent supplied from a liquid source (such as container 22 (FIG. 2A)) and an inflow of pressurized gas supplied by a compressor 14 (FIG. 2A) operable by a suitable controller 30. This method of generating high-pressure, high-speed jet sprays is well known in the prior art, particularly in PCT Publication No. WO 2005 / 065032 and European Patent No. 1883447, cited above by the applicant, which describe the discharge of liquid into a high-speed gas stream to form an accelerated mist or spray of liquid.

[0081] As shown in Figure 3A, the co-treatment handheld component 300 consists of a cylindrical sheath 302 having a proximal end and a distal end, respectively designated 310 and 312. An operating end component 320 (e.g., an electro-reflection probe in this document) formed of any suitable conductive material is mounted to the distal end 312 by means of a support arm 314.

[0082] As can also be seen in Figures 3A to 4 and Figures 7A to 8B, a sheath-like cylindrical sheath 302 is configured to fit over the spray delivery handpiece 200, such that the nozzle 230 protrudes through the distal end 312 of the cylindrical sheath 302.

[0083] When the spray handheld device 200 and the symbiotic therapeutic handheld device element 300 are assembled together, the opening 321 of the nozzle 230 and the operating end member 320 are considered to be substantially coaxial. Also as seen, the operating end member 320 is considered to extend beyond the nozzle 230 so as to be displaced distally from the nozzle along axis 240, and thus closer to the skin 110 during treatment, such that the contact surface 323 contacts the skin, while the nozzle 230 is spaced apart from the skin. As described, the sheath 302 is formed to partially wrap around the spray housing 202 to form an integral handheld device suitable for holding in and operating with a single hand of the user. Furthermore, the respective proximal ends 210 and 310 of the housing 202 and the sheath 302 are fastened together by a hollow connector 120, which is shown and described in more detail below in conjunction with Figures 5A to 6.

[0084] Referring now to Figures 5A and 6, the connector 120 has a proximal end 142 and a distal end 144. The proximal end 142 has a proximal opening 143 through which an umbilical tube 28 passes to facilitate the supply of an operating medium to the component hands 200 and 300, respectively. The distal end 144 has an opening 145 and is configured to connect to the proximal end 310 of the sheath 302 of the symbiotic therapeutic element 300. The connector 120 and the sheath 302 can be connected, for example, by adhesive or welding, as seen in Figures 5A and 5B. Alternatively, as illustrated in Figures 3A and 6, the connector 120 and the sheath 302 can be connected by a clamp 345 to facilitate a snap-fit ​​connection between them. According to yet another embodiment, clamp 345 may be configured to be pressed inward as illustrated by a push button as shown in 347, thereby facilitating the disengagement of connector 120 from sheath 302 for maintenance purposes when necessary. As mentioned, the connection between connector 120 and sheath 302 (which is a simple mechanical connection between two polymer components) can be achieved by any suitable means known in the art (such as adhesive), and therefore will not be described in further detail herein.

[0085] The umbilical hose 28 has a distal end 282, which is fitted directly inside the connector 120. Each of the air tube 16, the liquid tube 24, and the wire 26 extends from the distal end 282 of the hose 28 to provide the operating medium to a corresponding portion of the integral handheld component 100, whereby the air tube 16 is connected to a corresponding air inlet tube 216 that extends inward into the spray housing 202; the liquid tube 24, carrying a solution of water and selected therapeutic substances, is connected to a corresponding liquid inlet conduit 224 via suitable connectors 225 and 227; and the wire 26 is connected via a suitable pin connector 326 to a suitably positioned electrical conductor 327 for conducting charge to the end member 320.

[0086] As illustrated in Figure 4, by way of illustrative example only, conductor 327 may be embedded or otherwise formed within the wall of sheath 302 to have a distal end portion 329, which overlaps with and contacts the proximal portion 331 of end member 320 in an overlapping area generally designated 333.

[0087] As is well known in the art and again with reference to Figure 2B, it is known that exposing skin 110 to jet spray 242 is for the purpose of providing a predefined therapy, such as infusion. Jet spray 242 provides a focused jet with predefined qualities (such as pressure, flow rate, jet pattern, droplet size, droplet velocity, effect on the skin, reach, etc.) to facilitate transdermal infusion as mentioned above.

[0088] The spray 242 consists of high-speed, high-pressure microdroplets that bombard and thus impact the skin. These microdroplets possess kinetic energy, which effectively causes them to act as solids upon impact with the skin, and, depending on the angle at which the handheld device is held relative to the skin, produces an injection effect, thereby injecting a liquid carrying a therapeutic agent into the skin. As shown in the accompanying drawings, when the spray handheld device 200 is perpendicular or nearly perpendicular to the skin, cavitation occurs, resulting in the formation of grooves or recesses 111 in the skin 110. This causes the skin in which the grooves 111 are formed to be stretched, thereby opening micropores in the skin for injection of the spray components and generating gas and liquid cavitation bubbles in the skin tissue.

[0089] Simultaneously, when the symbiotic therapeutic handheld element 300 is an electrostatic handheld element and the end element 320 is an electrostatic probe, the operation of the operating end element 320 of element 300, while maintaining contact with the skin 110, exposes the surrounding recessed area 111 of the dermis and the portion 113 below it to charge. This increases the porosity of the dermis, thereby facilitating more effective penetration of the spray therapy.

[0090] As shown in Figure 9 below, when the symbiotic therapeutic handheld component uses an ultrasonic transducer 420, a similar effect is achieved with necessary modifications, wherein the recessed area 111 is exposed to ultrasonic radiation.

[0091] Referring now to Figure 2C, the end member 320 extends distally from the integral handheld member 100, as described below, and is exemplified herein as an annular circular opening 321 with a radius "R". Additionally, as can be seen, the end member 320 is generally mounted coaxially with and orthogonal to the nozzle 230, such that the axis 240 passes through the geometric center of the opening 321, as shown in the figure.

[0092] The probe 320 has a distal contact surface 323 that maintains contact with the subject's skin 110 (FIG. 2B) during use, extending beyond the nozzle 230 by a dimension equal to the applied distance "z" from its pre-selected spray. As is known in the art, the distance the spray is directed to the subject's skin 110 can vary depending on the treatment and even during different phases of a single treatment. In the prior art, the handpiece is entirely held by the user, and therefore, this distance is difficult to measure; it is approximate and difficult to maintain, making its consistency in a single treatment dependent on the stability of the hand of the person applying the treatment. However, in this invention, the distal contact surface 323 is held against the skin 110, such that the applied distance "z" is known before treatment. Furthermore, as will be appreciated from the description below in FIG. 7A through FIG. 12B, the applied distance "z" is adjustable. According to one embodiment, such as those seen in Figures 7A to 7C, component 320 is slidably adjustable, while in the embodiments of Figures 8A to 8B, a screw mechanism is provided. These are merely examples, and other means of adjusting the component 320 are also considered to be within the scope of this application.

[0093] Therefore, and as seen in the embodiments of Figures 7A to 7C, where the symbiotic therapeutic element 300 is an electroremoval element, the support arm 314 of the electroremoval probe extends rearward through a channel 122 formed between the spray jet housing 202 and the sheath 302 (Figures 7B and 7C). A T-shaped slider element 124 is generally positioned parallel to axis 240 within an elongated viewing window 330 formed in the sidewall 332 of the sheath 302. The slider element 124 has an inwardly radially extending protrusion 126 extending through an opening 334 in the support arm 314. Thus, it will be appreciated that the position of the contact surface 323 and consequently the magnitude of the spray application distance "z" can be adjusted by sliding the slider element 124 within the viewing window 330, where the maximum value Zmax and the minimum value Zmin are illustrated in Figures 7B and 7C, respectively.

[0094] In the embodiments of Figures 8A and 8B, the operating end member 320 (illustrated herein by way of example as the electro-removal probe 320) is screw-mounted onto the distal end 312 of the cylindrical sheath 302 by means of a proximal annular portion 340 having internal threads (not visible), the internal threads cooperating with external threads 342 formed on the distal end 312 of the sheath 302. As illustrated in Figure 8A, the probe 320 can be rotated along the thread 342 in a first direction 344 to increase the spray application distance "z" up to a maximum value Zmax. Additionally, as illustrated in Figure 8B, the probe 320 can be rotated along the thread 342 in a second direction 346 opposite to the first direction to decrease the spray application distance "z" up to a minimum value Zmin.

[0095] Those skilled in the art will understand that the adjustment mechanisms illustrated in Figures 7A to 8B are merely examples, and any suitable mechanism for achieving the same purpose is within the scope of this invention.

[0096] Referring now to Figure 9, what is seen is an integral handheld device, generally designated 400, in which the symbiotic therapeutic element is an ultrasound element. In other respects, handheld device 400 is generally similar to handheld device 100 as shown and described above in conjunction with Figures 2A to 7C. The portions of the illustrated device 400 shown and described above are illustrated in these figures by similar reference numerals, and when compared with handheld device 100, device 400 is described only regarding the differences.

[0097] In this embodiment, the operating end member is exemplified as an ultrasonic transducer 420, which is shown as an arcuate shape in FIG. 9 and, herein, as a complete circular ring. Thus, in a manner similar to that illustrated in FIG. 2B, the transducer 420 and nozzle 230 are coaxially aligned such that the jet spray 242 (FIG. 2B) impacts the subject's skin 110 at the center of the area 113 exposed to ultrasound, as shown and described in conjunction with FIG. 2B and FIG. 2C. Precise construction of ultrasonic transducers is well known in the art and is therefore beyond the scope of this invention. A typical circular transducer may be manufactured by PZT Electronic Ceramic Co., Ltd., located at 15 Dezheng West Road, Changan Town, Dongguan City, Guangdong Province, China, and selected from its product list at https: / / www.piezoelements.com / piezo-ceramic / piezo-ring / .

[0098] Depending on the embodiment, the shape of the operating end member does not need to be particularly circular. For example, as illustrated in FIG10, the operating end member can be U-shaped, as shown by the U-shaped transducer 420'. The spatial positioning of the transducer 420' is generally similar to that shown and described above with reference to FIG1C, and is mounted such that the contact surface 423' of the transducer surrounds the axis in a plane orthogonal to the axis 240.

[0099] Referring now to Figures 11 to 12B, what is seen is an integral handheld device 500, in which the exemplified symbiotic therapeutic element combines two end members to achieve two different techniques. In this example, the symbiotic therapeutic element combines complementary dermal therapeutic component parts, labeled 320' and 420', which are formed as combined end members 520. The outer member 320' is an electroreflective probe, and the inner member 420' is an ultrasonic transducer.

[0100] Except as specifically described below, the handheld device 500 is generally similar to the handheld devices 100 and 400 shown and described above in conjunction with Figures 2A to 10. In these figures, similar reference numerals are used to illustrate the parts of the illustrated device 400 shown and described above, and when compared with handheld devices 100 and 400, the device 500 is described only for the differences.

[0101] As can be seen in the enlarged cross-section of the combined end member 520, the two parts are considered to be arranged in a nested ring configuration to ensure that they move synchronously during adjustment so that their distal contact surfaces (323' and 423', respectively) are coplanar.

[0102] Referring now to Figure 13, what is seen in Figure 13 is a rigid spacer element 620, which is formed of any suitable material (typically rigid plastic) for accurately positioning the nozzle 230 of the delivery head 220 of the spray delivery handpiece 200 relative to the subject's skin 110.

[0103] Element 620 is mounted to the distal end 212 of handheld part 200 by means of a support arm 614 and an adjustable mount 615, the support arm and the adjustable mount being operable to be slidable or otherwise adjustable along the housing 202 of handheld part 200. In practice, the adjustable mount may be replaced by any suitable sliding or threaded attachment device similar to those shown and described above in conjunction with Figures 7A to 8B. Similar to probe 320, element 620 is exemplified herein as having a circular opening 621, thereby facilitating the spray 242 to pass through the opening. Element 620 has a contact portion 623 adapted to be placed against the skin 110 of the subject. As can be seen, element 620 limits the range in which the nozzle 230 can be positioned from the skin 110 during treatment to not less than the spray application distance "z", which varies from a minimum value Zmin to a maximum value Zmax. Typically, Zmin is about 5 mm and Zmax is 15 mm, but the actual range will be determined according to the requirements of different treatments.

[0104] Those skilled in the art will understand that the scope of this invention is not limited to what has been shown and described above by way of example only. Rather, the scope of this invention is defined only by the claims.

[0105] 10: Multi-technology dermal treatment system 12: Operating System 14: Air compressor 16: Air pipe 18: Cooling Unit 20: Power Supply Unit 22: Liquid containers 24: Liquid fittings 26: Electrical wire 28: Protective molded umbilical cord tubing 30: Control Panel 100: Handheld device 110: Skin 111: concave part 113: Part 120: Connector 122: Channel 124: T-shaped slider element 126: protrusion 142: Proximal end 143: Proximal opening 144: distal end 145: Opening 200: Spray delivery handheld item 202: Slender sealed housing 210: Proximal end 212: distal end 216: Air intake pipe 220: Delivery Head 224: Liquid enters the conduit 225: Connector 227: Connector 230: Nozzle 240: Axis 241: Plane 242: Therapeutic spray 282: Distal end 300: Symbiotic Therapeutic Element 302: Sheath 310: Proximal end 312: distal end 314: Support arm 320: Operating end component | Electrically removed probe 320': Complementary Dermal Therapy Components | External Components 321: Opening 323: Genuine leather touch surface 323': Distal contact surface 326: Pin Connector 327: Electrical conductor 329: Distal end portion 330: Slender window 331: Proximal part 332: Sidewall 333: Overlapping region 334: Opening 340: Proximal annular portion 342: External thread 344: First Direction 345: Fixture 346: Second Direction 347: Press down button 400: Handheld device 420: Ultrasonic transducer 420': Complementary Dermal Therapy Components | Internal Components 423: Touching the surface 423': Distal contact surface 500: Handheld device 614: Support arm 615: Adjustable mounting hardware 620: Component 621: Circular opening 623: Touching part 1080: Gas Inlet Port 1100: Liquid Inlet Port 1160: Liquid discharge nozzle 1200: Convergence Part 1220: Throat 1240: Dispersion Emissions Section 1241: 1260: Exhaust airflow 1280: Opening 1300: Droplet mist 1340: Arrow Z: Spray application distance ZMAX: Maximum value of Z ZMIN: Minimum value of Z

[0106] Domestic storage information (please note in order of storage institution, date, and number) none

[0107] Overseas storage information (please note in the order of storage country, institution, date, and number) none

Claims

1. A multi-technology dermal treatment integrated handheld device, comprising: An integral spray delivery handheld device includes: an airtight, elongated linear housing having an axis of symmetry, terminating at a delivery head having at least one therapeutic spray nozzle for guiding a therapeutic spray toward the skin of a subject along an axis at a spray application distance from the skin of the subject, wherein the at least one therapeutic spray nozzle includes: at least one gas exhaust nozzle aligned with the axis of symmetry for receiving and delivering a gas flow pressurized in the range of 40-150 psi into the atmosphere, thereby generating a shock wave upon exiting the at least one gas exhaust nozzle, the at least one gas exhaust nozzle having an inner diameter; and at least one linear liquid exhaust nozzle having a longitudinal axis extending through the at least one gas exhaust nozzle coaxial with it, and having an outer diameter smaller than the inner diameter of the at least one gas exhaust nozzle, the at least one linear liquid exhaust nozzle having an opening for discharging a therapeutic liquid flow into the pressurized gas flow. The therapeutic fluid stream is exposed to the shock wave to atomize it into microdroplets. The atomized fluid combines with the airflow to generate a high-speed, concentrated jet of the therapeutic microdroplets along an axis. These microdroplets have predetermined qualities to facilitate transdermal delivery of the microdroplets to the subject's skin at a predetermined spray application distance. The system also includes at least one electrically operable symbiotic therapeutic handheld element terminated at an operating end member with a dermal contact surface for delivering a treatment to the skin, the treatment being symbiotic with the treatment provided by the therapeutic spray. The operating end member and the contact surface are laterally spaced from the axis, and a mechanism positions the operating end member and the contact surface beyond the at least one therapeutic spray nozzle at a spray application distance, the size of which is within a predetermined range, such that the operating end member is electrically operable when positioned at the spray application distance.

2. The handheld device as claimed in claim 1, wherein the operating end member of the at least one symbiotic therapeutic handheld device element is adjustable relative to the at least one therapeutic spray nozzle, thereby correspondingly adjusting the spray application distance within the predetermined range.

3. The handheld device as claimed in claim 1, wherein the at least one symbiotic therapeutic handheld device element comprises a first symbiotic therapeutic handheld device element and a second symbiotic therapeutic handheld device element.

4. The handheld device as claimed in claim 1, wherein the operating end member and the leather contact surface are bent and mounted so as to remain in a plane transverse to the spray axis.

5. The handheld device as claimed in claim 4, wherein the leather touch surface is arc-shaped and has a center of curvature intersecting the spray axis in a plane perpendicular to the spray axis.

6. The handheld device as claimed in claim 1, wherein the at least one symbiotic therapeutic handheld device element further comprises: A cylindrical sheath having a proximal end and a distal end, the cylindrical sheath being configured to at least partially surround the housing of the spray delivery handpiece, such that the at least one therapeutic spray nozzle protrudes through the distal end of the cylindrical sheath; and a support for mounting the operating end member to the distal end of the cylindrical sheath to position the touch surface relative to the at least one therapeutic spray nozzle at a distance equal to the predetermined spray application distance.

7. The handheld device of claim 6, wherein the operating end member is electrically driven, and the at least one symbiotic therapeutic handheld device element includes an electrically conductive element for supplying power from a power source to the operating end member.

8. The handheld device of claim 7, wherein the spray delivery handheld device includes a liquid supply tube positioned within the housing for supplying a liquid suspension of a therapeutic agent, wherein the liquid supply tube terminates at a proximal end at a liquid connector leading to an external liquid source, the housing terminates at a proximal end at a gas connector leading to a pressurized gas source, and the electrically conductive element terminates at a proximal end at an electrical connector leading to an external power source, and wherein the handheld device further includes a hollow connector connected to the proximal end of the cylindrical sheath for receiving the liquid connector, gas connector, and electrical connector.

9. The handheld device as claimed in claim 8, wherein the hollow connector and the cylindrical sheath are coupled together via a clamp.

10. The handheld device of claim 1, wherein the at least one symbiotic therapeutic handheld device element is an electro-removal element, and the operating end member is an electro-removal probe.

11. The handheld device of claim 1, wherein the at least one co-existing therapeutic handheld device element is an ultrasonic element, and the operating end member is an ultrasonic transducer.

12. The handheld device as claimed in claim 3, wherein the first symbiotic therapeutic handheld device element is an electro-removal element and its operating end member is an electro-removal probe, and the second symbiotic therapeutic handheld device element is an ultrasonic element and its operating end member is an ultrasonic transducer.

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