Claims for Patent: 9,005,158

Summary for Patent: 9,005,158

Title:	Eradication of pigmentation and scar tissue
Abstract:	The invention is a non-surgical method for the eradication of pigmentation and scar tissue from an area of skin. The method comprises repeatedly puncturing the area of skin with an array of needles. As the needles are inserted into the skin, the needles and surface of the skin are washed with a clean solution. As the needles are withdrawn from the skin, the flow of clean solution ceases and the dirty solution, which contains cellular fluids and pigments released by the action of the needles, is removed from the surface. The invention is also a solution, which is used to clean the needles and to aid in destroying the pigment containing cells, and an apparatus, which is especially designed to move the needles into and out of the surface of the skin and to provide synchronization of the motion of the needles and flow of the solution such as to maximize the effectiveness of the method.
Inventor(s):	Danenberg; Noam (Hod Hasharon, IL), Nesher; Ori (Herzliya, IL)
Assignee:	Hawk Medical Technologies Ltd. (Ra\'Anana, IL)
Application Number:	11/997,411
Patent Claims:	1. An apparatus adapted for eradicating pigmentation in an area of skin, the apparatus comprising: a handle portion including a motor and a gear assembly for causing a reciprocating motion to a shaft connected to the gear assembly; a barrel portion surrounding the shaft, a first end of the barrel portion attached to the handle portion and a second end of the barrel portion including a tip configured and arranged to form a hermetic seal with the area of skin; an array of needles attached to an end of the shaft near the tip; an inlet port in the barrel portion, the inlet port connected to solution storage means; an outlet port in the barrel portion, the outlet port connected to suction means; a piston attached to the shaft above the array of needles, the piston configured and arranged as a cylindrical valve that is operable to provide a hydraulic seal separating a volume inside the barrel portion above the piston from a volume below the piston and to synchronize opening and closing of the inlet port and the outlet port; an inlet hole in a side wall of the piston, the inlet hole fluidly connected to a bottom of the piston thereby providing a fluid path from the volume inside the barrel portion below the piston to the inlet hole; and an outlet hole in a side wall of the piston, the outlet hole fluidly connected to the bottom of the piston thereby providing a fluid path from the volume inside the barrel portion below the piston to the outlet hole; wherein activation of the motor causes the array of needles to alternatively be pushed out of the tip of the barrel portion to puncture the area of skin to mechanically damage cells containing pigment and to be withdrawn from the area of skin back into the tip, wherein during each downward stroke of the shaft the outlet port is closed by not being lined up with the outlet hole and the inlet port is opened by being lined up with the inlet hole such that solution in the solution storage means flows through the piston into the volume inside the barrel portion below the piston onto the needles thereby rinsing the needles and a surface of the area of skin, wherein during each upward stroke of the shaft the inlet port is closed by not being lined up with the inlet hole and the outlet port is opened by being lined up with the outlet hole thereby allowing solution which flowed onto the surface of the area of skin during the downward stroke and cellular fluids and pigments released by puncturing action of the needles to be sucked through the piston out of the volume inside the barrel portion by the suctioning means, wherein synchronization of opening and closing of the inlet port and the outlet port insures separation of clean and dirty fluid in the tip and minimizes an amount of solution permeating the surface of the area of skin. 2. A method of using the apparatus according to claim 1 comprising: providing a solution in the solution storage means; connecting said solution storage means and suction means to the apparatus; and activating the motor of the apparatus for a predetermined period of time. 3. The method according to claim 2, wherein the solution includes a chemical selected from the group consisting of EDTA, DMSO, Collagenase, Hyaluronidase, Papain, Bromelain hypertonic Saline, Salicylic acid, Aloe, Bidentis, Kalanchoes, Eucalyptus, Chamomile, Calendula, Saliva oficinalis, Helichrysum arenarium, and Hydrogen peroxide. 4. The method according to claim 3, wherein the solution is an aqueous solution including salicylic acid at a concentration between 2% and 5%. 5. An apparatus for removing skin pigmentation comprising: a barrel defining a shaft and including a tip configured to create a seal when positioned at a surface area of the skin, the barrel having a handle end and a needle end; a handle connected to the barrel; an inlet port within the barrel for introducing a fluid into the shaft; an outlet port within the barrel for removing the fluid from the shaft; a valve movable within the shaft between a first position and a second position, the valve configured to enable passage of the fluid from the inlet port to the shaft in the first position and from the shaft to the outlet port in the second position, the valve configured to block the fluid from passing from the inlet port to the shaft in the second position; and an array of needles provided at the needle end of the shaft and connected to the valve, the needles thereby movable with the valve between the first position and the second position, the needles extending a distance beyond the tip of the barrel at the first position thereby puncturing the area of skin when the tip is positioned at a surface area of the skin while the valve is in fluid communication with the needles thereby applying the fluid to the area of skin during puncturing; wherein the valve is configured to block the fluid from passing to the outlet port in the first position and the valve includes an inlet hole alignable with the inlet port at the first position but not at the second position, and the valve includes an outlet hole alignable with the outlet port at the second position but not at the first position. 6. The apparatus according to claim 5, further comprising a motor attached to the valve and operable to move the valve between the first position and the second position. 7. The apparatus according to claim 5, the fluid comprising an aqueous solution of salicylic acid. 8. The apparatus according to claim 7, wherein concentration of the salicylic acid in the aqueous solution is between 2% and 5%. 9. The apparatus according to claim 5, wherein the array needles are extendable to puncture into the skin at a depth of 3 mm or less in the first position. 10. The apparatus according to claim 5, wherein the inlet port is arranged relatively closer to the tip of the barrel than the outlet port. 11. The apparatus according to claim 5, the array of needles comprising between 7 needles to 38 needles. 12. A method for eradicating pigmentation in an area of skin, said method comprising repeatedly puncturing said area of skin with an array of needles while rinsing said array of needles with clean solution each time that they puncture said area of skin, said method carried out by: a) providing an apparatus that comprises: a handle portion including a motor and a gear assembly for causing a reciprocating motion to a shaft connected to the gear assembly; a barrel portion surrounding the shaft, a first end of the barrel portion attached to the handle portion and a second end of the barrel portion including a tip configured and arranged to form a hermetic seal with the area of skin; an array of needles attached to an end of the shaft near the tip; an inlet port in the barrel portion, the inlet port connected to solution storage means; an outlet port in the barrel portion, the outlet port connected to suction means; a piston attached to the shaft above the array of needles, the piston configured and arranged as a cylindrical valve that is operable to provide a hydraulic seal separating a volume inside the barrel portion above the piston from a volume below the piston and to synchronize opening and closing of the inlet port and the outlet port; an inlet hole in a side wall of the piston, the inlet hole fluidly connected to a bottom of the piston thereby providing a fluid path from the volume inside the barrel portion below the piston to the inlet hole; and an outlet hole in a side wall of the piston, the outlet hole fluidly connected to the bottom of the piston thereby providing a fluid path from the volume inside the barrel portion below the piston to the outlet hole; b) activating the motor thereby causing the array of needles to alternatively be pushed out of the tip of the barrel portion to puncture the area of skin and to mechanically damage cells containing pigment and to be withdrawn from the area of skin back into the tip, wherein during each downward stroke of the shaft the outlet port is closed by being not lined up with the outlet hole and the inlet port is opened by being lined up with the inlet hole such that solution in the solution storage means flows through the piston into the volume inside the barrel portion below the piston onto the needles thereby rinsing the needles and a surface of the area of skin, wherein during each upward stroke of the shaft the inlet port is closed by not being lined up with the inlet hole and the outlet port is opened by being lined up with the outlet hole thereby allowing solution which flowed onto the surface of the area of skin during the downward stroke and cellular fluids and pigments released by puncturing action of the needles to be sucked through the piston out of the volume inside the barrel portion by the suctioning means. 13. The method according to claim 12, wherein the solution is an aqueous solution of salicylic acid having a concentration of between 2% and 5%. 14. The method according to claim 13, wherein duration of the puncturing of the area of skin and applying of the aqueous solution of salicylic acid is no longer than thirty minutes. 15. The method according to claim 12, wherein the pigmentation is from a tattoo. 16. The method according to claim 12, wherein the pigmentation is due to a natural process. 17. The method according to claim 16, wherein the natural process is selected from the group consisting of healing of wounds, freckles, age spots, and birth marks. 18. The method according to claim 12, wherein the needles puncture the skin to a depth of 3 mm or less.

Details for Patent 9,005,158

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Bausch & Lomb Incorporated	VITRASE	hyaluronidase	Injection	021640	05/05/2004		2025-08-01
Bausch & Lomb Incorporated	VITRASE	hyaluronidase	Injection	021640	12/02/2004		2025-08-01
Amphastar Pharmaceuticals, Inc.	AMPHADASE	hyaluronidase	Injection	021665	10/26/2004		2025-08-01
Akorn, Inc.	HYDASE	hyaluronidase	Injection	021716	10/25/2005		2025-08-01
Smith & Nephew, Inc.	SANTYL	collagenase	Ointment	101995	06/04/1965		2025-08-01