WO2019006109A1 - Système, appareil et procédé pour administrer une solution dans les pores de la peau d'un mammifère receveur - Google Patents

Système, appareil et procédé pour administrer une solution dans les pores de la peau d'un mammifère receveur Download PDF

Info

Publication number
WO2019006109A1
WO2019006109A1 PCT/US2018/039985 US2018039985W WO2019006109A1 WO 2019006109 A1 WO2019006109 A1 WO 2019006109A1 US 2018039985 W US2018039985 W US 2018039985W WO 2019006109 A1 WO2019006109 A1 WO 2019006109A1
Authority
WO
WIPO (PCT)
Prior art keywords
sleeve
needle
internal diameter
external diameter
tip
Prior art date
Application number
PCT/US2018/039985
Other languages
English (en)
Inventor
Pedro Medrano
Original Assignee
Sebacia, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Sebacia, Inc. filed Critical Sebacia, Inc.
Publication of WO2019006109A1 publication Critical patent/WO2019006109A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M37/0092—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin using ultrasonic, sonic or infrasonic vibrations, e.g. phonophoresis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2210/00—Anatomical parts of the body
    • A61M2210/04—Skin

Definitions

  • This application relates to a needle system, apparatus and method for delivery of materials into the skin of a mammal.
  • an apparatus delivers solution into pores of a human's skin
  • the apparatus comprises a needle having an external diameter at its distal end and a tip and a sleeve having an external diameter, a first internal diameter at a first end and a second internal diameter at a second end, the second internal diameter of the sleeve is greater than the first internal diameter of the sleeve, the first internal diameter of the sleeve is fit with the external diameter of the needle, the second internal diameter of the sleeve forms a circumferential space around the external diameter of the needle and the second end of the sleeve extends beyond the tip of the needle.
  • the needle can be an ultrasonic needle.
  • the second internal diameter is about 0.2 millimeters to about 4.0 millimeters greater than the external diameter of the needle; the external diameter of the needle is about 3.0 millimeter and the first internal diameter of the sleeve is about 2.8 millimeters and the second internal diameter of the sleeve is about 3.2 millimeters; the tip of the needle is about 100 micrometers to about 2.0 millimeters below the second end of the sleeve; the tip of the needle is about 100 micrometers to about 1.0 millimeters below the second end of the sleeve; the tip of the needle is about 100 micrometers to about 500 micrometers below the second end of the sleeve.
  • a cover having a first surface for contacting skin, and having a center opening, the center opening interfaces with the external diameter of the sleeve.
  • the first surface of the cover comprises channels in a pattern that direct solution to the center opening.
  • the pattern is a pinwheel pattern, a radial pattern, or a spider web pattern.
  • a second needle having an external diameter at its distal end and a tip; and a second sleeve having an external diameter, a first internal diameter at a first end and a second internal diameter at a second end, the second internal diameter of the second sleeve is greater than the first internal diameter of the second sleeve, the first internal diameter of the second sleeve is fit with the external diameter of the second needle, the second internal diameter of the second sleeve forms a circumferential space around the external diameter of the second needle and the second end of the second sleeve extends beyond the tip of the needle.
  • a system to deliver solution into pores of a human's skin.
  • the system comprises a drive; a transducer connected with the drive, the transducer providing a massage effect; a needle having an external diameter at its distal end, a proximal end connected with the transducer, and a tip; a sleeve having an external diameter, a first internal diameter at a first end and a second internal diameter at a second end, the second internal diameter of the sleeve is greater than the first internal diameter of the sleeve, the first internal diameter of the sleeve is fit with the external diameter of the needle, the second internal diameter of the sleeve forms a circumferential space around the external diameter of the needle and the second end of the sleeve extends beyond the tip of the needle; a head having a center opening, the center opening interfaces with the external diameter of the sleeve; and a head cover having a first surface for
  • a method for delivering solution into a human's skin comprises applying solution to the human's skin; applying a delivery system to the human's skin, the delivery system comprises: a needle having an external diameter at its distal end and a tip; and a sleeve having an external diameter, a first internal diameter at a first end and a second internal diameter at a second end, the second internal diameter of the sleeve is greater than the first internal diameter of the sleeve, the first internal diameter of the sleeve is fit with the external diameter of the needle, the second internal diameter of the sleeve forms a circumferential space around the external diameter of the needle and the second end of the sleeve extends beyond the tip of the needle.
  • an apparatus to deliver solution into pores of a human's skin.
  • the apparatus comprises a needle having an external diameter at its distal end and a tip; a cover having an opening at its distal end; and a ring having an external diameter and an internal diameter, the internal diameter of the ring forms a circumferential space around the external diameter of the distal end of the needle and the external diameter of the ring interfaces with the opening of the cover.
  • the needle can have a single lumen cover for coolant to flow or can have a double lumen cover for coolant to flow.
  • An absorbent disc can be included that abuts the ring at the distal end of the ring.
  • the internal diameter of the ring has a surface, and a channel exists through the surface of the internal diameter of the ring to and through a proximal end of the ring.
  • the sleeve has an interior and an exterior and a hole connecting the interior to the exterior where the hole is through the second internal diameter of the sleeve and can be connected to a pressure source of gas, gases, or air. where the pressure source assists movement of a solution into the circumferential space.
  • the pressure source can be a vacuum.
  • Example data of the benefits in accordance with the invention is a height hi of solution of about 15 mm, about 20 mm or about 38 mm.
  • the sleeve has an interior and an exterior and a first hole and a second hole connecting the interior to the exterior where the first hole and the second hole are both through the second internal diameter of the sleeve and the first hole can be connected to a pressure source of gas, gases, or air, where the pressure source assists movement of a solution into the circumferential space.
  • the pressure source can be a blower.
  • Example data of the benefits in accordance with the invention is a height hi of solution of about 33 mm when a pressure of about 2.4 to about 4.7 liter/minute is applied.
  • Example data of the benefits in accordance with the invention is a distance from the tip of the needle to the second end of the sleeve is about 9.53 mm.
  • the circumferential space around the external diameter of the needle is about 0.2 mm wide, the circumferential space has a height of about 9.53 mm from the tip of the needle to a proximal end of the circumferential space.
  • the first hole and the second hole each have a diameter of about 3.18 mm, each with a center axes of about 34.93 mm from the second end of the sleeve.
  • the method for delivering solution into a human's skin further comprises applying pressure to the delivery system from a pressure source of gas, gases, or air connected to a hole in the sleeve.
  • the sleeve has an interior and an exterior and the hole connects the interior to the exterior.
  • the hole is through the second internal diameter of the sleeve and the pressure source assists movement of a solution into the circumferential space.
  • the pressure source can be a vacuum.
  • Example data of the benefits in accordance with the invention of a height hi of solution is about 15 mm, about 20 mm or about 38 mm.
  • the method for delivering solution into a human's skin further comprises applying pressure to the delivery system from a pressure source of gas, gases or air connected to one of a first hole and a second hole in the sleeve.
  • the sleeve having an interior and an exterior and both the first hole and the second hole connect the interior to the exterior.
  • the holes are through the second internal diameter of the sleeve and the pressure source assists movement of solution into the circumferential space.
  • the pressure source can be a blower.
  • Example data of the benefits in accordance with the invention is a height hi of solution of about 33 mm when a pressure of about 2.4 to about 4.7 liter/minute is applied.
  • Example data of the benefits in accordance with the invention is a distance from the tip of the needle to the second end of the sleeve is about 9.53 mm.
  • the circumferential space around the external diameter of the needle is about 0.2 mm wide, the circumferential space has a height of about 9.53 mm from the tip of the needle to a proximal end of the circumferential space.
  • the first hole and the second hole each have a diameter of about 3.18 mm, each with a center axes of about 34.93 mm from the second end of the sleeve.
  • an absorbent material can be located within the second internal diameter of the sleeve, where the absorbent material can be a foam cylinder.
  • FIG. 1 is a cross section diagram conceptually depicting a delivery system with a ultrasonic needle apparatus for the delivery of a substance or a solution into pores of a human's skin;
  • FIG. 2 is a cross section diagram depicting an exemplary device head interfaced, not fully seated, with an exemplary device head cover of the delivery system as shown in FIG. 1, in accordance with an embodiment of the present invention
  • FIG. 2(a) is a view of a device head in accordance with an embodiment of the present invention.
  • FIGS. 3 and 3(a) are cross section diagrams of an illustrative ultrasonic needle apparatus as applied to a human's skin in accordance with an embodiment of the present invention
  • FIG. 4 is a cross section diagram of an illustrative ultrasonic needle apparatus in accordance with an embodiment of the present invention
  • FIGS. 5 (a) and (b) are diagrams depicting at least a cross section portion of an exemplary ultrasonic needle apparatus with emphasis on exemplary dimensions, in accordance with an embodiment of the present invention
  • FIGS. 6(a) and (b) are cross section diagrams of ultrasonic needle systems, apparatuses and methods in accordance with embodiments of the invention.
  • FIGS. 7(a) and (b) are cross section diagrams of ultrasonic needle systems, apparatuses and methods in accordance with embodiments of the invention.
  • FIGS. 8(a) and (b) are cross section diagrams of ultrasonic needle systems, apparatuses and methods in accordance with embodiments of the invention.
  • FIGS. 9(a)-(d) are cross section and side view diagrams depicting exemplary fluid channels for head covers, in accordance with embodiments of the present invention.
  • FIG. 10 is a cross section diagram generally depicting three ultrasonic needle apparatuses, in accordance with an embodiment of the present invention.
  • FIG. 11 is a cross section diagram showing an exemplary height of a solution as a result of capillary forces in a reservoir cavity, in accordance with an embodiment of the invention.
  • FIG. 12(a)-(c) are cross section diagrams of an ultrasonic needle apparatus, system and method in accordance with embodiments of the invention.
  • FIG. 13(a)-(c) are cross section diagrams of an ultrasonic needle apparatus, system and method in accordance with embodiments of the invention.
  • Embodiments of the present invention will be described herein in the context of an exemplary needle apparatus for delivering substances and/or solutions into pores of a human's skin. It is to be appreciated, however, that the invention is not limited to the specific apparatus illustratively shown and described herein. Rather, embodiments of the invention are directed to an apparatus having a reservoir cavity or a reservoir and techniques for beneficially delivering substances into pores of a human's skin. Moreover, it will become apparent to those skilled in the art given the teachings herein that numerous modifications can be made to the embodiments shown that are within the scope of the present invention. For simplicity, substance and/or solution and/or formulation and/or a suspension of particles are herein referred to as a solution.
  • the invention is directed towards an apparatus, system and method for facilitating the delivery of a solution into the pores of a human's skin, after and while the solution is topically applied (e.g., dripped from a syringe).
  • a reservoir cavity having a circumferential space is formed by a tight dimensional design between an ultrasonic needle and a sleeve surrounding the needle.
  • a reservoir is formed by a tight dimensional design between an ultrasonic needle and a ring surrounding the needle.
  • a head cover such as a molded silicone rubber head cover, surrounds the sleeve or the ring to provide comfort to the patient and to facilitate the flow of solution.
  • Certain embodiments of the invention are accomplished, in part, by directing a solution into a pore using the effects of cavitation of ultrasonic energy application to the solution in the reservoir cavity or reservoir, without employing an internal source of solution. The result is a micro-reservoir of solution in intimate contact with the skin without resorting to a configuration where a large volume of solution must be kept in contact with the skin during the application of ultrasonic energy.
  • the delivery of solution into the pores of a recipient mammal's skin relies on capillary forces to wick solution into a circumferential space of a reservoir cavity or a reservoir wherein an ultrasonic needle, once wetted, delivers the necessary energy to create cavitation and bubble collapse in the solution thereby driving solution into the pores.
  • low pressure, suction or negative pressure is created at the proximal end of the reservoir cavity, relative to the distal end, causing the solution to be pushed or drawn upwards into the circumferential space resulting in greater, and continual wetting of the ultrasonic needle. It is to be understood that the invention is not limited to an ultrasonic needle and that other needle types may be used.
  • FIG. 1 is a cross section diagram conceptually depicting a delivery system with an ultrasonic needle apparatus for the delivery of a solution into pores of a human's skin.
  • a device body 105 is employed that is capable of driving a transducer 110 to provide a massage effect by way of, for example, pulsations, percussions, vibrations, oscillations or combinations thereof in targeted surface areas of human skin.
  • Systems and methodologies for driving and providing a massage effect are well known in the art.
  • ultrasonic needle apparatus 120 Connected to transducer 110 is an ultrasonic needle apparatus 120.
  • Ultrasonic needle apparatus 120 includes an ultrasonic needle 135 with a tip and a sleeve 130 that wraps around ultrasonic needle 135.
  • Ultrasonic needle 135 (e.g., fine probe, horn) is rigidly connected by its proximal end to transducer 110 via screw thread.
  • the components of ultrasonic needle apparatus 120 form a reservoir cavity 205, which is generally depicted in FIGS. 2, 3 and 3(a).
  • reservoir cavity 205 and its narrow circumferential space is defined by the dimensions of ultrasonic needle 135 and the surrounding enclosure defined by sleeve 130. It is to be understood that the invention is not limited to an ultrasonic needle and that other needle types may be used.
  • Ultrasonic needle 135 is connected with sleeve 130 and sleeve 130 is connected with a device head 115, as generally depicted in FIGS. 3 and 4.
  • Device head 115 has a center through-hole that is press fit with the external diameter of sleeve 130.
  • Transducer 110 causes ultrasonic needle 135 and sleeve 130 to oscillate in a longitudinal or in a transverse direction.
  • sleeve 130 is in contact with the device head 115, as a result device head 115 may also oscillate.
  • the tip of ultrasonic needle 135 is generally applied vertically or perpendicularly to a patient's skin.
  • device body 105 is a handheld apparatus.
  • a device head cover 125 having a through-hole 140 and a concave side, interfaces with device head 115 and ultrasonic needle apparatus 120, as shown in FIGS. 1 and 2.
  • Device head 115 can have a nipple 207 for receiving device head cover 125, as shown in FIG. 2(a).
  • Device head cover 125 ensures a comfortable contact surface for the patient's skin.
  • FIG. 1 depicts device head cover 125 removed from device head 115
  • FIG. 2 depicts device head cover 125 interfaced with device head 115, but not yet fully seated on device head 115.
  • device head cover 125 is shaped so that its concave side interfaces with a convex side of device head 115.
  • device head cover 125 is connected to device head 115 by press-fitting through-hole 140 of device head cover 125 onto the external diameter of the cylindrical enclosure that makes up sleeve 130. This ensures a comfortable contact surface for the patient's skin.
  • Device head cover 125 can be made from various types of materials. In this embodiment of the present invention device head cover 125 is made from silicone rubber.
  • FIG. 3 is a cross section diagram of ultrasonic needle apparatus 120 applied to a human's skin 305, in accordance with an embodiment of the present invention.
  • Ultrasonic needle apparatus 120 and reservoir cavity 205 are illustrated in relation to skin 305 of a patient.
  • Fig. 3 shows secondary delivery (e.g., topically applying) of a solution 315 by a syringe 310 to the surface of skin 305 independently of ultrasonic needle apparatus 120. It should be realized that solution 315 can be delivered prior to or while device head cover 125 and sleeve 130 are in contact with skin 305.
  • FIG. 4 depicts in detail a cross section view of ultrasonic needle apparatus 120 with device head cover 125 and device head 115 engaged with sleeve 130.
  • there are two internal diameters of sleeve 130 a small internal diameter 410 and a large internal diameter 415.
  • the engagement of ultrasonic needle 135 and sleeve 130 creates reservoir cavity 205, formed around needle 135, having a narrow circumferential space that extends radially from the external diameter of needle 135 to large internal diameter 415 of sleeve 130.
  • the diameter of small internal diameter 410 of sleeve 130 is directly related to the external diameter of ultrasonic needle 135 so that ultrasonic needle 135 fits tightly, by way of press fit or friction fit, within sleeve 130.
  • the tightness of the fit is controlled by the amount of interference.
  • an interference fit of about 0.05 to about 0.1 millimeters is provided so that sleeve 130 cannot slip off needle 135.
  • the diameter of large internal diameter 415 of sleeve 130 in relation to the diameter of ultrasonic needle 135 determines the size of reservoir cavity 205.
  • the large internal diameter 415 of sleeve 130 is depicted in FIGS. 5(a) and 5(b).
  • FIGS. 5(a) and (b) show a cross section view and a quarter view, respectively, of ultrasonic needle apparatus 120 with emphasis on exemplary dimensions, in accordance with an embodiment of the present invention.
  • ultrasonic needle 135 has a needle diameter of about 3.0 millimeters ("mm").
  • Sleeve 130 has a small internal diameter 410 that is slightly smaller than the about 3.0 mm diameter of ultrasonic needle 135 so that ultrasonic needle 135 can be tightly fit into sleeve 130. For example about 2.8 mm.
  • a circumferential space 510 is formed by the separation between needle 135 and sleeve 130 and is selected from within a preferred range from about 0.1 mm to about 2.0 mm for an ultrasonic needle diameter of about 3.0 mm.
  • large internal diameter 415 is preferred to be within a range of about 3.2 mm to about 7.0 mm for an about 3.0 mm needle.
  • the preferred width of circumferential space 510 would be selected from within a preferred range from about 0.1 mm to about 2.0 mm greater than the diameter of the external diameter of the ultrasonic needle.
  • the circumferential space defines a micro-reservoir where the dimension of the circumferential space between the needle and the sleeve should generally be less than the diameter of the ultrasonic needle.
  • head cover 125 has a through-hole 140 with a diameter larger than the external diameter of sleeve 130, there will be space for ultrasonic needle 135 and sleeve 130 to oscillate more freely.
  • exemplary dimensions of reservoir cavity 205 are described in relation to needle-skin clearance.
  • the needle-skin clearance is the amount of space between the tip of ultrasonic needle 135 and the distal end of sleeve 130, as depicted in FIG. 5(b).
  • a needle- skin clearance 530 is preferred to be within a range of about 100 micrometers to about 2.0 millimeters, about 100 micrometers to about 1.0 millimeter, and about 100 micrometers to about 500 micrometers.
  • a circumferential space 510 of about 100 micrometers to about 500 micrometers is preferred.
  • FIG. 6(a) is a cross section diagram of an ultrasonic needle system and apparatus in accordance with an embodiment of the invention.
  • a ring 614 is provided that defines a circumferential space for use as a reservoir, around the distal end of a needle, that improves the delivery of substances into pores of a human's skin.
  • FIG. 6(a) depicts an ultrasonic needle 608 within a single lumen cover 606.
  • Single lumen cover 606 can be made from various types of materials.
  • single lumen cover 606 is made from silicone.
  • Single lumen cover 606 has a distal end inner diameter that is smaller than the outer diameter of ultrasonic needle 608 so as to form a compression fit when single lumen cover 606 is placed over ultrasonic needle 608, as shown in FIG. 6(a).
  • Ultrasonic needle 608 includes a threaded end 601 that can connect to, for example, a transducer. The distal end of the ultrasonic needle is slightly larger in diameter than the elongated body of the needle.
  • ultrasonic needle 608 has a central bore and a set of through holes near its distal end so that coolant fluid can flow through ultrasonic needle 608, as shown by the arrows in FIG. 6(a). Coolant flows through a coolant inflow 602, through the single lumen, and through the holes near the distal end of needle 608, before exiting at a coolant outflow 604.
  • a device head 610 attaches, by its proximal end, to device body 105.
  • Device head 610 includes a hole 618 in its center that allows for the distal end of ultrasonic needle 608 to pass through.
  • Device head 610 and a head cover 612 are attached and held together by an interference fit.
  • Device head cover 612 can be made from various types of materials. In this embodiment of the invention device head cover 612 is made from silicone rubber.
  • Device head cover 612 includes a hole 616 in its center that the distal end of ultrasonic needle 608 can pass through. Ring 614 is press fit into hole 616 and its distal end sits below the exterior contact surface of device head cover 612.
  • the distal end of ultrasonic needle 608 resides within the through hole of ring 614 such that a circumferential space 600 with a precise dimension is created between the outer diameter of the needle tip and the inner diameter of ring 614.
  • a circumferential space 600 of about 100 micrometers to about 500 micrometers is preferred.
  • the tip of needle 608 is displaced from the exterior contact surface of device head cover 612 by a precise dimension 620.
  • Dimension 620 is preferred to be within a range of about 100 micrometers to about 2.0 millimeters, about 100 micrometers to about 1.0 millimeter, and about 100 micrometers to about 500 micrometers.
  • the embodiment depicted in FIG. 6(b) includes an ultrasonic needle 609, which is a solid ultrasonic needle, within a dual-lumen cover 607.
  • dual-lumen cover 607 has a coolant inflow 603 and a coolant outflow 605 creating a path for coolant to flow alongside ultrasonic needle 609. Coolant flows through coolant inflow 603, through double-lumen cover 607, before exiting at a coolant outflow 605, as shown by the arrows in FIG. 6(b).
  • FIG. 7(a) is a cross section diagram of an ultrasonic needle system and apparatus in accordance with an embodiment of the invention.
  • a ring 714 and an absorbent disc 720 are provided that define a circumferential space for use as a reservoir, around the distal end of a needle, that improves the delivery of substances into pores of a human's skin.
  • the system and apparatus in FIG. 7(a) is similar to the system and apparatus described in reference to FIG. 6(a).
  • absorbent disc 720 with a through hole is included to help draw fluid into a circumferential space, which can enhance the wicking effect of an applied solution.
  • FIG. 7(a) absorbent disc 720 with a through hole is included to help draw fluid into a circumferential space, which can enhance the wicking effect of an applied solution.
  • FIG. 7(a) depicts an ultrasonic needle 708 placed within a single lumen cover 706, a device head 710 with a hole 718, and a device head cover 712 with a hole 716.
  • Ring 714 is press fit within hole 716 of device head cover 712.
  • absorbent disc 720 is also press fit into hole 716 to abut ring 714 while being flush with the exterior contact surface of head cover 712.
  • Absorbent disc 720 can be an absorbent material, such as a foam disc.
  • device head 710 attaches, by its proximal end, to device body 105.
  • FIG. 7(b) The system and apparatus depicted in FIG. 7(b) is similar to the system and apparatus described in reference to FIG. 7(a).
  • the embodiment depicted in FIG. 7(b) includes an ultrasonic needle 709, which is a solid ultrasonic needle, within a dual-lumen cover 707.
  • dual-lumen cover 707 has a coolant inflow 703 and a coolant outflow 705 creating a path for coolant to flow alongside ultrasonic needle 709. Coolant flows through a coolant inflow 703, through double-lumen cover 707, before exiting at a coolant outflow 705, as shown by the arrows in FIG. 7(b).
  • FIG. 8(a) is a cross section diagram of an ultrasonic needle system and apparatus in accordance with an embodiment of the invention.
  • the system and apparatus depicted in FIG. 8(a) is similar to the system and apparatus described in reference to FIG. 6(a).
  • the embodiment depicted in FIG. 8(a) includes a fluid channel to facilitate the flow of a solution to the distal end of the ultrasonic needle system and apparatus.
  • FIG. 8(a) depicts an ultrasonic needle 808 placed within a single lumen cover 806, a device head 810 with a hole 818, and a device head cover 812 with a hole 816. Ring 814 is pressed fit within hole 816 of device head cover 812.
  • the fluid channel includes a fluid tube 820 that facilitates the flow of a solution from a fluid source 822 to a ring port 824.
  • Ring port 824 is an inlet to a ring fluid channel 826 within ring 814.
  • the outlet of ring fluid channel 826 directs the flow of solution to a circumferential space between the distal end of needle 808 and ring 814.
  • Ring fluid channel 826 can also be designed as a circumferential groove so that the solution wicks around the entire periphery of the needle-ring circumferential space.
  • device head 810 attaches, by its proximal end, to device body 105.
  • FIG. 8(b) The system and apparatus depicted in FIG. 8(b) is similar to the system and apparatus described in reference to FIG. 8(a).
  • the embodiment depicted in FIG. 8(b) includes an ultrasonic needle 809, which is a solid ultrasonic needle, within a dual-lumen cover 807.
  • dual-lumen cover 807 has a coolant inflow 803 and a coolant outflow 805 creating a path for coolant to flow alongside ultrasonic needle 809. Coolant flows through a coolant inflow 803, through double-lumen cover 807, before exiting at a coolant outflow 805, as shown by the arrows in FIG. 8(b).
  • the ultrasonic needle in the embodiments described in reference to FIGS. 6(a) through 8(b) could be, for example, a fine probe or horn type.
  • device head cover 125 can have different fluid channels or depressions in the form of patterns on its surface to further facilitate the flow of solution 315 on a patient's skin 305. These channels and patterns also enhance the filling of reservoir cavity 205.
  • the different patterns can be included in a mold cavity for manufacturing of a device head cover. The patterns can be optimized so that solution on a patient's skin can be directed towards the center of device head cover 125 and reservoir cavity 205.
  • FIGS. 9(a) through (d) show: an exemplary pinwheel pattern, radial pattern, spider web pattern, and a second type of pinwheel pattern, respectively. These small recessed patterns on the exterior surface (patient contact surface) of device head cover 125 help drive topically applied solution to the center region of the head cover 125, in combination with, for example, a circular motion of device head cover 125.
  • FIG. 10 is a cross section diagram generally depicting three ultrasonic needle apparatuses 705 connected to device head 115, in accordance with an embodiment of the invention.
  • a larger reservoir cavity or a larger reservoir can be defined by inserting into the reservoir cavity or into the reservoir an absorbent material, such as a foam cylinder, that can help draw fluid into circumferential space. If the clearance between the ultrasonic needle/probe tip and skin is too great and the circumferential space between the sleeve and needle/probe is too narrow, or both, wicking of the fluid can become poor and as such, there could be no coupling between the needle/probe and the fluid.
  • an absorbent material such as a foam cylinder
  • wicking of the fluid can become poor and as such, there could be no coupling between the needle/probe and the fluid.
  • the wicking effect can be enhanced by filling the circumferential space with an absorbent material that would be in contact with the skin, and hence in contact with the fluid resident on the surface of the skin.
  • FIGS. 12 through 13 illustrate alternative embodiments of an ultrasonic needle apparatus, system and method where low pressure, suction, negative pressure is created within a proximal end of a reservoir cavity to assist mechanical and/or capillary forces.
  • low pressure is created at the proximal end of the reservoir cavity by applying low pressure to the reservoir cavity (FIGS. 12(a)-(c)).
  • low pressure is created at the proximal end of the reservoir cavity by passing high speed air through the proximal end of the reservoir cavity (FIGS. 13(a)-(c)). In both of these embodiments the result is lower pressure at the proximal end of the reservoir cavity relative to the distal end.
  • the higher pressure at the distal end of the reservoir cavity helps the solution within the reservoir cavity to rise into the circumferential space towards the lower pressure at the proximal end of the reservoir cavity.
  • the difference in air pressure between the distal end and proximal end of reservoir cavity results in air flowing from the area of high pressure to the area of low pressure. This difference in pressure causes upward suction, which helps move solution into circumferential space, in accordance with the invention. Because the circumferential space is defined by the ultrasonic needle and the sleeve the solution in the circumferential space is in contact with the ultrasonic needle, providing greater continual wetting of the needle thereby improving the delivery of solution into pores of a human's skin.
  • FIG. 11 emphasizes an exemplary height (h 0 ) that a solution 1117 may achieve within a circumferential space 1120 as a result of mechanical and/or capillary forces, without the benefit of the addition of low pressure at the proximal end of reservoir cavity 1104.
  • the movement of solution 1117 in reservoir cavity 1104 requires the collection of the topically applied solution by the apparatus head, and driving or diverting solution 1117 to and up circumferential space 1120 by way of a wicking effect.
  • the efficacy of this process depends on factors such as the wetting behavior of the solution on the skin, the interaction between the solution and the collecting features of the apparatus head, and the motion of the apparatus over the skin.
  • FIGS. 12(a) through (c) are cross section diagrams of an ultrasonic needle apparatus, system and method in accordance with the embodiments of the invention.
  • FIG. 12(a) is a cross section diagram showing ultrasonic needle apparatus 1222 with a reservoir cavity 1204 in relation to skin 1205 of a patient.
  • Ultrasonic needle apparatus 1222 is structured with a port 1206 that provides access to reservoir cavity 1204.
  • FIG. 12(b) shows cross section view of ultrasonic needle 1208 in relation to sleeve 1212 with port 1206.
  • Port 1206 is a through hole connecting reservoir cavity 1204 to the outside of sleeve 1212, as shown in FIGS. 12(a).
  • Port 1206 connects the interior of sleeve 1212 to the exterior of sleeve 1212.
  • Port 1206 is located near the proximal end of reservoir cavity 1204 and in the portion of the wall of sleeve 1212 that makes up circumferential space 1220, as shown in FIGS. 12(a) and (c).
  • FIG. 12(c) is a cross section diagram showing ultrasonic needle apparatus 1222 as part of a system that creates a difference in pressure between the distal end and the proximal end of reservoir cavity 1204.
  • Port 1206 connects to an air handling hose 1252 which connects to an air management device 1250, effectively connecting reservoir cavity 1204 to air management device 1250.
  • Air management device 1250 includes a pressure source capable of producing reduced pressure.
  • Air management device 1250 can be, for example, a micro pump or mini pump that provides reduced air pressure or suction for use in medical applications, or can be for example, a reservoir of air at a reduced pressure.
  • Air management device 1250 can be adjustable, regulated and also include components such as controllers, sensors, user interface and indicators.
  • Hose 1252 is a suction line suitable for the operating pressure of the pressure source and is connected by leak-tight connections. Arrows illustrated in hose 1252 indicate the direction of air flow when air management device 1250 is active.
  • air management device 1250 creates a pressure lower than the pressure in reservoir cavity 1204.
  • air management device 1250 When air management device 1250 is activated, a low pressure environment or partial vacuum in air management device 1250 is created.
  • the air pressure level in air management device 1250 is reduced to a pressure below the air pressure level in reservoir cavity 1204 causing air to flow from reservoir cavity 1204, out through port 1206.
  • the air in reservoir cavity 1204 moves upwards.
  • the air pressure at the proximal end of reservoir cavity 1204 is lower then the air pressure at the distal end of reservoir cavity 1204, causing the air at the distal end to push itself upwards and into circumferential space 1220.
  • This difference in pressure causes upward suction, which assists in the movement of solution 1217 into circumferential space 1220, in accordance with the inventions.
  • FIG. 12(a) and (c) illustrates an exemplary level that solution 1217 may rise to with the addition of upward suction, in accordance with the invention.
  • heights h 0 (FIG. 11) and hi (FIGS. 12(a), (c)) represent exemplarily levels intended to show that the solution achieves a greater height in the circumferential space when suction is applied to reservoir cavity 1204.
  • FIGS. 13(a) through (c) are cross section diagrams of an ultrasonic needle apparatus, system and method in accordance with embodiments of the invention.
  • FIG. 13(a) is a cross section diagram showing ultrasonic needle apparatus 1322 with a reservoir cavity 1304 in relation to skin 1305 of a patient.
  • Ultrasonic needle apparatus 1322 is structured with a port 1306 and a port 1307 that provide access to reservoir cavity 1304.
  • sleeve 1312 has ports 1306 and 1307.
  • FIG. 13(b) shows cross section view of ultrasonic needle 1308 in relation to sleeve 1312 with ports 1306 and 1307. Both ports 1306 and 1307 are through holes connecting the outside of sleeve 1312 to reservoir cavity 1304, as shown in FIG. 13(a). Ports 1306 and 1307 connect the interior of sleeve 1312 to the exterior of sleeve 1312.
  • Ports 1306 and 1307 are located diametrically opposite of each other near the proximal end of reservoir cavity 1304 and in the portion of the wall of sleeve 1312 that makes up the circumferential space 1320, as shown in FIGS. 13(a) and (c).
  • FIG. 13(c) is a cross section diagram showing ultrasonic needle apparatus 1322 as part of a system that creates a difference in pressure between the distal end and the proximal end of reservoir cavity 1304.
  • Port 1306 connects to air handling hose 1352 which connects to an air management device 1350, effectively connecting reservoir cavity 1304 to air management device 1350.
  • Air management device 1350 includes a pressure source capable of producing increased pressure.
  • Air management device 1350 can be, for example, a micro pump or mini pump that provides increased or high air pressure for use in medical device applications, or can be for example, a reservoir of air at an increased pressure.
  • Air management device 1350 can be adjustable, regulated and also include components such as controllers, sensors, user interface and indicators.
  • Hose 1352 is a pressure line suitable for the operating pressure of the pressure source and is connected by leak-tight connections. Arrows illustrated in hose 1352 indicate air flow direction when air management device 1350 is active.
  • air management device 1350 creates high speed air flow.
  • air management device 1350 When air management device 1350 is activated, high speed air is funneled into hose 1352. The high speed air enters port 1306, through reservoir cavity 1304 and out through port 1307, resulting in traverse air flow across the proximal end of reservoir cavity 1304. While the high speed air passes through ports 1306 and 1307, lower air pressure is created at the proximal end of reservoir cavity 1304 relative to the air pressure at the distal end. Because the air pressure in reservoir cavity 1304 is higher at the distal end than at the proximal end, the air at the distal end moves upwards.
  • the air pressure at the proximal end of reservoir cavity 1304 is lower than the air pressure at the distal end of reservoir cavity 1304, causing the air at the distal end to pushes itself upwards and into circumferential space 1320.
  • This difference in pressure causes upward suction, which assists in the movement of solution 1317 into circumferential space 1320, in accordance with the invention.
  • height (hi) represent an exemplarily level that is intended to show that the solution achieves a greater height in the circumferential space when suction is applied to reservoir cavity.
  • Exemplary data is provided showing improvements in the height hi a solution can achieve by creating low pressure within the circumferential space of the ultrasonic needle apparatuses, in accordance with the embodiments of the invention described in reference to FIGS. 12-13.
  • the solution height h 0 channel fluid height
  • the solution height h 0 channel fluid height
  • mm millimeters
  • a low, a medium, and a high pressure suction / vacuum were applied to ultrasonic needle apparatus 1222, resulting in the height hi (channel fluid height) of solution 1217 improving to about 15 mm, about 20 mm and about 38 mm, respectively.
  • a vacuum pump was connected to port 1206.
  • circumferential space 1320 is about 0.2 mm wide with height of about 9.53 mm.
  • the needle- skin clearance is also about 9.53 mm with a diameter of about 1.65 mm.
  • the needle-skin clearance is the amount of space between the tip of ultrasonic needle 1308 and the distal end of sleeve 1312.
  • the diameters of ports 1306 and 1307 are about 3.18 mm, each having center axes of about 34.93 mm measured from the distal end of sleeve 1312.
  • contouring of the surfaces in transverse airflow pathway e.g., ports 1306 and 1307) help to create negative pressure.
  • the delivery system distributes a solution into the pores of a human's skin for the treatment of acne.
  • a solution is applied to a skin surface and the solution is distributed from the skin surface to a target tissue area under the skin surface by the delivery system.
  • the solution includes energy absorbing sub- micron particles such as nanoparticles including a conductive metal portion.
  • the conductive metal may be, for example, gold or silver.
  • the nanoparticles can have a variety of shapes, such as rods, plates and/or spheres.
  • the spheres can, for example, be hollow, solid or porous.
  • the particles can be provided in the solution alone or with a payload.
  • a cosmetic or pharmaceutical substances can be coated on, or provided within, the nanoparticle, or provided as part of the solution.
  • the nanoparticles are introduced into the target tissue region and activated with a laser-based system of the type that is well known in the art to achieve hair removal or to treat acne, among other conditions.
  • Exemplary nanoparticle formulations are known in the art, and can be found, for example, in US 2015/0045723A1 and US 2013/0315999 Al, incorporated herein by reference in their entirety.
  • the delivery system facilitates the delivery of the nanoparticles and/or photoactive compounds to the target tissue.
  • distal end is defined as that portion lying in the direction of the patient, the "proximal end” being in the direction of the device body or attached, directly or indirectly, to the device body.

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Dermatology (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medicinal Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Medical Informatics (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

L'invention concerne un système, un appareil et un procédé pour faciliter l'administration d'une solution dans les pores de la peau d'un être humain. Conformément à des modes de réalisation de la présente invention, une cavité de réservoir est formée avec des dimensions serrées entre une aiguille et un manchon entourant l'aiguille, et un réservoir est formé avec des dimensions serrées entre une aiguille et un anneau. Selon des modes de réalisation de l'invention, un couvercle de tête, tel qu'un couvercle de tête en caoutchouc de silicone moulé, entoure le manchon pour fournir un confort au patient et faciliter l'écoulement de solution.
PCT/US2018/039985 2017-06-30 2018-06-28 Système, appareil et procédé pour administrer une solution dans les pores de la peau d'un mammifère receveur WO2019006109A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201762527504P 2017-06-30 2017-06-30
US62/527,504 2017-06-30

Publications (1)

Publication Number Publication Date
WO2019006109A1 true WO2019006109A1 (fr) 2019-01-03

Family

ID=64742646

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2018/039985 WO2019006109A1 (fr) 2017-06-30 2018-06-28 Système, appareil et procédé pour administrer une solution dans les pores de la peau d'un mammifère receveur

Country Status (1)

Country Link
WO (1) WO2019006109A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2021074119A1 (fr) * 2019-10-18 2021-04-22 Ionto Health & Beauty Gmbh Pièce à main à ultrasons

Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4446967A (en) * 1982-05-07 1984-05-08 Halkyard Douglas R Germicide sleeve for dental and medical instruments
US4610683A (en) * 1985-07-17 1986-09-09 Manresa, Inc. Suction needle
US4903710A (en) * 1987-01-06 1990-02-27 Jessamine John G Surgical isolation drapes
US5403288A (en) * 1992-02-13 1995-04-04 Stanners; Sydney D. Safety sleeve for dental syringe
US5421816A (en) * 1992-10-14 1995-06-06 Endodermic Medical Technologies Company Ultrasonic transdermal drug delivery system
US5562610A (en) * 1994-10-07 1996-10-08 Fibrasonics Inc. Needle for ultrasonic surgical probe
US6524278B1 (en) * 1998-09-04 2003-02-25 Nmt Group Plc Needle sheath
US20050283120A1 (en) * 2004-06-21 2005-12-22 Hsien-Tsung Wang Adapable safety syringe

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4446967A (en) * 1982-05-07 1984-05-08 Halkyard Douglas R Germicide sleeve for dental and medical instruments
US4610683A (en) * 1985-07-17 1986-09-09 Manresa, Inc. Suction needle
US4903710A (en) * 1987-01-06 1990-02-27 Jessamine John G Surgical isolation drapes
US5403288A (en) * 1992-02-13 1995-04-04 Stanners; Sydney D. Safety sleeve for dental syringe
US5421816A (en) * 1992-10-14 1995-06-06 Endodermic Medical Technologies Company Ultrasonic transdermal drug delivery system
US5562610A (en) * 1994-10-07 1996-10-08 Fibrasonics Inc. Needle for ultrasonic surgical probe
US6524278B1 (en) * 1998-09-04 2003-02-25 Nmt Group Plc Needle sheath
US20050283120A1 (en) * 2004-06-21 2005-12-22 Hsien-Tsung Wang Adapable safety syringe

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2021074119A1 (fr) * 2019-10-18 2021-04-22 Ionto Health & Beauty Gmbh Pièce à main à ultrasons

Similar Documents

Publication Publication Date Title
EP3030180B1 (fr) Appareil utilisable avec des matériaux activables par l'énergie
JP4469610B2 (ja) 皮膚アクセス部材
US6210400B1 (en) Flexible flow apparatus and method for the disruption of occlusions
US7740626B2 (en) Laser induced liquid jet generating apparatus
CN108697279A (zh) 皮肤美容装置的手持件
US20070299369A1 (en) Ultrasound wound care device and method
JPS61179150A (ja) 組織体内の細胞質除去装置
US20050137520A1 (en) Catheter with ultrasound-controllable porous membrane
US20030078533A1 (en) Method and apparatus for in-vivo transdermal and/or intradermal delivery of drugs by sonoporation
JPS63502162A (ja) 超音波減結合スリーブを備えた外科用器具
WO2019006109A1 (fr) Système, appareil et procédé pour administrer une solution dans les pores de la peau d'un mammifère receveur
CN108366666B (zh) 用于口腔卫生设备的附接组件
JP2017060733A (ja) 光ガイド溝を有する光学針
Stoeber et al. Design, fabrication and testing of a MEMS syringe
KR100200669B1 (ko) 향상된 스프레이 기능을 갖는 레이저 핸드피스
US20060036191A1 (en) Ultrasonic system for treatment of otolaryngologic diseases and ultrasonic instrument for these purposes and ultrasonic otolaryngologic set.
CN107715195B (zh) 一种外科腔道创面治疗用负压引流冲洗装置
KR20180107064A (ko) 초음파를 이용한 약물 및 화장품 주입 장치
WO2008085911A1 (fr) Buse d'application amovible à canaux multiples
KR20170137471A (ko) 초음파를 이용한 약물 및 화장품 주입 장치
KR102550158B1 (ko) 선형 이동 가능한 초음파 프로브를 구비하는 체강 삽입형 초음파 장치
US20080152510A1 (en) Valve for controlling flow of a primary fluid
US20230204023A1 (en) Apparatus and methods for medical applications of laser-driven microfuild pumps
US20220249821A1 (en) Technologies for needles with microchannels
US10912885B2 (en) Device and method for infusing and aspirating fluid

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 18822895

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 18822895

Country of ref document: EP

Kind code of ref document: A1