The present disclosure generally relates to handheld devices for dermal administration of therapeutic agents.
Handheld devices for dermal abrasion of exposed in vivo tissue are known in the art. One such device is described in the present applicant's International Publication No. WO 2005/065032, “A High Velocity Liquid-Gas Mist Tissue Abrasion Device”, included herein by reference. This document also provides a general overview of dermal abrasion and dermal abrasion devices.
Disclosed in the above referenced document is a device for dermal abrasion employing a high-velocity liquid-gas jet spray, formed of droplets of a therapeutic agent in liquid suspension. The spray applied to the skin of a subject as a streaming mist. The mist-like properties of the spray may be advantageous for some purposes, whereas, for other purposes such as infusion, such properties, accompanied by a loss of speed, and a loss of force of the spray generally and of its component droplets in particular, the mist-like properties may render it less effective.
In the disclosure hereinbelow, the term “distal” refers to portions of the device furthest from a user operating the device, that is, closest to a jet spray delivery end of the device. The term “proximal” refers to portions of the device closest or most proximate to the user that is, the portion furthest from the jet spray delivery end of the device.
The term “tissue” as used herein can refer to either human or animal tissue.
The following embodiments and aspects thereof are described and illustrated in conjunction with systems, tools and methods which are meant to be exemplary and illustrative, not limiting in scope.
In addition to the exemplary aspects and embodiments described above, further aspects and embodiments will become apparent by reference to the figures and by study of the following detailed description.
There is thus provided, in accordance with an embodiment of the invention, a dermal treatment handpiece having a body having proximal and distal ends; and a jet spray delivery head formed at the distal end of the body, the delivery head being connected to a source of a liquid suspension of a therapeutic agent and to a source of a pressurized gas for a selectable combined supply of the liquid suspension and of the pressurized gas, to the jet spray delivery head, wherein the jet spray delivery head includes a base formed at the distal end of the body, a localized environmental jet spray isolation chamber extending from the base to a distal exit port, a nozzle extending from into the isolation chamber from the base, the nozzle being connected to a combined inflow of the liquid suspension and the pressurized gas, and one or more tubes mounted within the nozzle for receiving the combined inflow, each tube having a delivery tip extending into the isolation chamber for emitting a high pressure, high velocity jet spray along a delivery axis in response to receiving the combined inflow.
Additionally, the jet spray has a formational integrity prone to the influence of deleterious, localized air currents, and the isolation chamber is operative to reduce the influence of deleterious, localized air currents on the jet spray during its passage therethrough, thereby increasing the efficacy of the jet spray as it exits the isolation chamber through the distal exit port, into the environment.
Further, the isolation chamber is formed of a cylindrical wall extending axially away from the base, terminating in a circumferential edge defining the distal exit port.
Additionally, there is provided a single tube for providing a single jet spray along a delivery axis.
Alternatively, there are provided three tubes for providing a combined jet spray along a delivery axis.
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Exemplary embodiments are illustrated in referenced figures. Dimensions of components and features shown in the figures are generally chosen for convenience and clarity of presentation and are not necessarily shown to scale. The figures are listed below.
Referring now to
The delivery head 100 has one (
The present description applies equally to the three-tube embodiment of
As seen in
As known, the exposure of skin 122 to jet spray 113 is so as to provide a predefined therapy, for example, exfoliation or lymphatic massage. The present invention is particularly suited for infusion, as will be described below. Jet spray 113 provides a focused jet having predefined qualities, such as pressure, flow rate, spray pattern, droplet size, droplet speed, impact on skin, reach, and the like, so as to facilitate to enable trans-epidermal infusion, as mentioned.
The jet spray 113 is composed of high speed, high pressure microdroplets which bombard and thus impact the skin. The microdroplets possess kinetic energy which effectively causes them to act as solids when impacting the skin, and depending on the angle that the handpiece is held relative to the skin, to have an infusive effect thereon, so as to infuse the therapeutic agent bearing liquid into the skin. When the handpiece 102 is held perpendicular or nearly perpendicular to the skin, cavitation occurs, causing the formation of a recess or dimple 124 in the skin. This causes the skin in which recess 124 is formed to be stretched, causing the opening of micropores in the skin for infusion of the jet spray components, with gas and liquid vacuoles created in the skin tissue.
Jet Spray Operating Conditions
This will be appreciated with reference to and in the context of a technical specification of a typical jet spray 113 emitted by delivery head 100:
Jet spray pressure: 85-95 psi
Volumetric flowrate of spray: this can vary, depending on the number of tubes 112, and the diameter of the tubes which in the present, non-limiting example, are 32 gauge hypodermic tubes. A typical flow rate may be in the range 12-40 liter/min.
Liquid output: this too can vary in a manner similar to the flowrate, and is also affected by the viscosity of the liquid. By way of example, when using distilled water with the presently exemplified embodiment, a liquid output of 1.5 gram/min is obtained.
Diameter of droplets in spray: 7-17 μm.
Speed of droplets in spray: 140-240 m/s
Impact Area on Skin when d=5 mm: 0.1-2.7 mm2
Impact Area on Skin when d=10 mm: 0.3-6 mm2.
It will be appreciated by persons skilled in the art that the formational integrity of the jet spray is of importance when providing an infusion treatment. This is due to the fact that while the jet spray 113 exits the delivery head 100 at high speed, the mass of the microdroplet spray is negligible, and is therefore highly susceptible to local atmospheric disturbances, particularly localized air currents such as may be caused by air conditioners, open windows, people walking close or even by the breath of the person holding and operating the handpiece.
As will be appreciated from the comparison of an example of the invention with a corresponding example of the prior art below, in conjunction with
Referring now briefly to
Jet Spray Pressure: 95 psi
Distance d from the skin: 15 mm
Note that the distance d as illustrated in
In addition to the formation of a dimple due to the above-described cavitation, a mist cloud 126 is seen to form in the vicinity of the spray, caused by deleterious, localized atmospheric disturbances, such as described above. This reduces the effectiveness of the infusion treatment that may be provided with a prior art handpiece as reflected in the shallowness of the dimple. This is described in greater detail below.
Referring now again to
The isolation chamber 130 is formed of a side wall 136, typically generally cylindrical or frustoconical in shape, which extends axially away from the base 132 so as to surround and extend beyond the delivery tips 115 (
It has been found by the inventors that in order to sufficiently minimize localized atmospheric disturbances to the formational integrity of the spray, it is sufficient to prevent such disturbances to the emergent portion only, of the spray as it leaves tube tips 115, indicated in
In the example pictured in
Referring now specifically to
The cavitation effectiveness of the delivery head 100 of the invention (
It will further be appreciated, that a further advantage of provision of the isolation chamber is to protect the delivery tips 115 of the tubes 112 from mechanical damage, whether by inadvertently touching the skin of a person being treated, or otherwise being knocked when not in use.
As used herein the term “configuring” and/or ‘adapting’ for an objective, or a variation thereof, implies using materials and/or components in a manner designed for and/or implemented and/or operable or operative to achieve the objective. Unless otherwise specified, the terms ‘about’ and/or ‘close’ with respect to a magnitude or a numerical value implies within an inclusive range of −10% to +10% of the respective magnitude or value. Unless otherwise specified, the terms ‘about’ and/or ‘close’ with respect to a dimension or extent, such as length, implies within an inclusive range of −10% to +10% of the respective dimension or extent. Unless otherwise specified, the terms “about” or “close” imply at or in a region of, or close to a location or a part of an object relative to other parts or regions of the object.
When a range of values is recited, it is merely for convenience or brevity and includes all the possible sub ranges as well as individual numerical values within and about the boundary of that range. Any numeric value, unless otherwise specified, includes also practical close values enabling an embodiment or a method, and integral values do not exclude fractional values. A sub range of values and practical close values should be considered as specifically disclosed values. As used herein, ellipsis ( . . . ) between two entities or values denotes an inclusive range of entities or values, respectively. For example, A . . . Z implies all the letters from A to Z, inclusively. Conjugated terms such as, by way of example, ‘a thing property’ implies a property of the thing, unless otherwise clearly evident from the context thereof.
The corresponding structures, materials, acts, and equivalents of all means or step plus function elements in the claims below are intended to include any structure, material, or act for performing the function in combination with other claimed elements as specifically claimed. As used herein, the singular forms “a”, “an” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms “comprises” and/or “comprising” and/or “includes” and/or “including” and/or “having” when used in this specification, specify the presence of stated features, integers, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and/or groups thereof.
The terminology used herein should not be understood as limiting, unless otherwise specified, and is for the purpose of describing particular embodiments only and is not intended to be limiting of the disclosed subject matter. While certain embodiments of the disclosed subject matter have been illustrated and described, it will be clear that the disclosure is not limited to the embodiments described herein. Numerous modifications, changes, variations, substitutions and equivalents are not precluded. Terms in the claims that follow should be interpreted, without limiting, as characterized or described in the specification.
The descriptions of the various embodiments of the present invention have been presented for purposes of illustration, but are not intended to be exhaustive or limited to the embodiments disclosed. Many modifications and variations will be apparent to those of ordinary skill in the art without departing from the scope and spirit of the described embodiments. The terminology used herein was chosen to best explain the principles of the embodiments, the practical application or technical improvement over technologies found in the marketplace, or to enable others of ordinary skill in the art to understand the embodiments disclosed herein.
The present application claims priority from U.S. provisional application Ser. No. 63/238,794 filed on Aug. 31, 2021, and from U.S. provisional application Ser. No. 63/278,128 filed on Nov. 11, 2021.
Number | Date | Country | |
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63238794 | Aug 2021 | US |