METHOD/DEVICE FOR TRANSDERMAL VASCULAR TREATMENT

• US 20110275979A1
• Filed: 05/15/2009
• Published: 11/10/2011
• Est. Priority Date: 05/15/2008
• Status: Active Grant

• Current Assignee: Biolitec Unternehmensbeteiligungs II AG
• Original Assignee: Biolitec Pharma Marketing Ltd.
• Inventors: López D'Ambola, Jorge O., Neuberger, Wolfgang, Soracco, Jorge E.
• Granted Patent: US 8,906,079 B2
• Time in Patent Office: Days
• US Class Current: 604/20
• CPC Class Codes: A61B 18/20 using laser
• CPC Class Codes: A61B 18/203 applying laser energy to the outside of the body
• CPC Class Codes: A61B 18/22 the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor
• CPC Class Codes: A61B 2017/00765 Decreasing the barrier function of skin tissue by radiated energy, e.g. using ultrasound, using laser for skin perforation
• CPC Class Codes: A61B 2018/00452 Skin
• CPC Class Codes: A61B 2018/00458 Deeper parts of the skin, e.g. treatment of vascular disorders or port wine stains
• CPC Class Codes: A61B 2018/206 the laser light passing along a liquid-filled conduit
• CPC Class Codes: A61B 2018/2065 Multiwave; Wavelength mixing, e.g. using four or more wavelengths pilot laser A61B2018/2025
• CPC Class Codes: A61N 2005/002 Cooling systems
• CPC Class Codes: A61N 2005/007 for cooling the patient
• CPC Class Codes: A61N 2005/0651 Diodes
• CPC Class Codes: A61N 2005/0659 infrared
• CPC Class Codes: A61N 5/06 using light
• CPC Class Codes: A61N 5/062 Photodynamic therapy, i.e. excitation of an agent
• CPC Class Codes: A61N 5/067 using laser light

Abstract

Devices and transdermal methods are provided for safe and effective therapeutic treatment of the venous system, such as varicose veins. Present invention provides non-invasive and minimally invasive transdermal methods for treating varicose and spider veins, comprising the use of a radiation source in combination with a chemical fluid/composition to safely and more effectively close or shrink vein walls, providing a transdermal therapeutic method for varicose veins until now only treated with surgery or endovascular laser treatments. In a preferred embodiment a device comprises a radiation source, preferably of wavelength between about 980 and 1940 nm, being effective in causing shrinkage of the vein treated. In other preferred embodiments methods comprise the transdermal delivery of a chemical composition through a patch or gel or the injection of a chemical fluid, preferably a hypertonic solution, to the vein under treatment; and simultaneously or after a dwell time, irradiating with a radiation source transdermally. The treatment performed with the present invention results in blood vessel wall damaged, eventually closing the vein, in lesser time with practically no pain or discomfort to the patient during and after the therapy.

Claims

1. A device for treating venous disorders transdermally, comprising

a radiation source, capable of providing laser radiation at a power level of at least one (1) Watt and at least one wavelength, preselected from a range of about 980 nm and 1940 nm;

means for transmitting said radiation;

a cooling system; and

means for directing said radiation transdermally onto the treatment zone and means for directing said cooling system.

2. The device according to claim 1, wherein said means for transmitting radiation is an optical waveguide.

3. The device according to claim 2, wherein said means for directing radiation and cooling is a handpiece, which is optically connected to said radiation source by said waveguide.

4. The device according to claim 1, wherein said preselected wavelength is about 1470±

50 nm.

5. The device according to claim 2, wherein said optical waveguide is an optical fiber.

6. The device according to claim 3, wherein said cooling system delivers a cool fluid through said handpiece transdermally to said treatment zone.

7. The device according to claim 1 wherein said means for directing radiation and cooling is a handpiece and further comprises:

a space limiting accessory;

a scale; and

a temperature sensing transducer.

8. The handpiece of claim 7, wherein said space limiting accessory can be locked at required distance from the treatment zone using said lock, while said distance from treatment zone can be measured using said scale on handpiece.

9. The handpiece of claim 7, wherein said temperature sensing transducer continuously monitors the temperature of skin at said treatment zone.

10. The chemical composition for use in treating vascular disorders transdermally with the device according to claim 1, wherein said composition is selected from a group consisting of a hypertonic solution, and a hypertonic solution and lidocaine solution.

11. The chemical composition of claim 10 wherein said hypertonic solution is a 20% hypertonic solution.

12. The chemical composition of claim 10 wherein said lidocaine solution is a 1% lidocaine solution.

13. A method for treating vascular disorders transdermally, comprising the steps of:

administering a chemical composition; and

irradiating of a treatment zone transdermally with a radiation source capable of providing radiation at a power level of at least one (1) Watt and at least one wavelength, preselected from a range of about 980 nm and 1940 nm.

14. The method according to claim 13, further comprising steps of:

cooling said treatment zone, and

evaluating said treatment zone using an echographic image.

15. The method according to claim 13, wherein said irradiating step employs a handpiece.

16. The method according to claim 13, wherein said chemical composition is administered through skin using one of a gel, patch and syringe.

17. The method according to claim 13, wherein said chemical composition is selected from the group consisting of a hypertonic solution, and a hypertonic solution and lidocaine solution.

18. The method according to claim 14, wherein said cooling of treatment zone is by application of aqueous cold gel transdermally on skin.

19. The method according to claim 14, wherein said cooling of treatment zone is done using a cooling system delivered by said handpiece.

20. The method according to claim 13, wherein said preselected wavelength is about 1470±

50 nm.

21. The method according to claim 15, wherein said handpiece is optically coupled to said radiation source using an optical fiber.

22. The method according to claim 13, wherein said vascular disorders comprise veins with a diameter of not more than 10-12 mm.