Laser system for improved transbarrier therapeutic radiation delivery

• US 6,355,054 B1
• Filed: 11/05/1999
• Issued: 03/12/2002
• Est. Priority Date: 11/05/1999
• Status: Expired due to Fees

• Current Assignee: CeramOptec Industries Incorporated (Biolitec AG)
• Original Assignee: CeramOptec Industries Incorporated (Biolitec AG)
• Inventors: Neuberger, Wolfgang
• Primary Examiner(s): PEFFLEY, MICHAEL F
• Application Number:
  US09/435,229
• Time in Patent Office: 858 Days
• Field of Search: 604/19-21, 606/2, 606/3, 606/9-15, 607/88, 607/89
• US Class Current: 607/89
• CPC Class Codes: A61B 18/18 by applying electromagnetic radiation, e.g. microwaves radiation therapy A61N5/00
• CPC Class Codes: A61B 18/203 applying laser energy to the outside of the body
• 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 2018/2005 with beam delivery through an interstitially insertable device, e.g. needle
• CPC Class Codes: A61B 2018/2261 with scattering, diffusion or dispersion of light
• CPC Class Codes: A61M 2037/0023 Drug applicators using microneedles
• CPC Class Codes: A61M 2037/003 having a lumen
• CPC Class Codes: A61M 2037/0046 Solid microneedles
• CPC Class Codes: A61M 37/0015 by using microneedles

Abstract

The present invention describes a system and method to improve radiation delivery through a barrier that may be encountered during therapeutic laser procedures, particularly where the objective of treatment is to produce thermal damage or alterations to subsurface tissue constituents without destroying or altering the overlying barrier. To achieve this result, a bio-compatible fluid is preoperatively administered to the tissue. The bio-compatible fluid is a light-scattering fluid that will scatter light primarily at the desired site thereby achieving a more uniform, enhanced heating over a relatively large treatment area. In addition, a second fluid, a dispersion fluid, can be added to the tissue to function in distributing the light scattering fluid throughout the treatment site. Laser radiation is then administered, through micro pores created for example by a device such as a micro-needle patch, into the treatment site. When a micro-needle patch is employed to deliver the fluid and the radiation, it can be a single patch for both functions, or a separate patch for each function.

Claims

1. A therapeutic laser delivery system for the improved transbarrier delivery of laser radiation across a biological barrier layer protecting a treatment site with improved uniformity of dispersion comprising:

a laser radiation source;

means for painlessly generating a multitude of newly formed micro pores in said biological barrier layer;

means for delivering a bio-compatible, transparent, light-scattering fluid to said treatment site;

means for optically connecting said laser radiation source to said newly formed micro pores; and

wherein said newly formed micro pores provide access to said treatment site for radiation from said laser radiation source.

2. A transbarrier, therapeutic laser delivery system according to claim 1, wherein said means for painlessly generating a multitude of newly formed micro pores in a biological barrier layer is a micro-needle patch, comprising a multitude of micro-needles.

3. A transbarrier, therapeutic laser delivery system according to claim 2, wherein said laser radiation source is coupled to said newly formed micro pores by an optical fiber bundle comprised of individual fibers, wherein said individual fibers are associated with at least one said newly formed micro pore.

4. A transbarrier, therapeutic laser delivery system according to claim 1, wherein said laser radiation source is coupled to said newly formed micro pores by an optical fiber bundle such that individual fibers are associated with at least one said newly formed micro pore.

5. A transbarrier, therapeutic laser delivery system according to claim 1, further comprising an optically transparent, bio-compatible dispersion fluid composed of 80% glycine and 20% water, wherein said dispersion fluid aids in pushing said light-scattering fluid to said treatment area.

6. A transbarrier, therapeutic laser delivery system according to claim 1, wherein said bio-compatible, transparent, light-scattering fluid is composed of oil and water, with about 1 to 5 parts oil in a 100-part mixture.

7. A transbarrier, therapeutic laser delivery system according to claim 2, wherein a single micro-needle patch, containing an array of micro-needles, is attached to both said laser radiation source and said fluid source whereby said fluid and said radiation are delivered in a simultaneous manner.

8. A transbarrier, therapeutic laser delivery system according to claim 2, wherein said micro-needle patch is optically transparent to said laser radiation, whereby optical fibers or said laser radiation source may be optically coupled to said micro-needle patch at a base of each said micro-needle.

9. A method of using the transbarrier, therapeutic laser delivery system according to claim 1, comprising placing said laser radiation source over said multitude of newly formed micro pores such that radiation from said laser radiation source is transmitted through said newly formed micro pores to said treatment site.

10. A method of using the transbarrier, therapeutic laser delivery system according to claim 2, comprising the step of administering said bio-compatible scattering fluid and a bio-compatible dispersion fluid to said treatment site through a pre-treatment micro-needle patch, which is removed prior to commencement of laser treatment with said micro-needle patch.

11. A method for improving the delivery of laser radiation for transbarrier therapeutic treatments comprising the steps of:

applying a micro poration technique to painlessly create a multitude of newly formed micro pores in a biological barrier protecting a treatment site;

injecting a bio-compatible, light-scattering fluid, capable of dispersing therapeutic radiation, through said multitude of newly formed micro pores into a tissue around said treatment site;

delivering said therapeutic radiation from a source to said treatment site through a suitable means and said multitude of newly formed micro pores; and

scattering said therapeutic radiation at said treatment site to promote improved uniformity and enhanced density of said radiation at said treatment site.

12. A method for improved delivery of laser radiation for transbarrier therapeutic treatments according to claim 11, wherein said applied micro poration technique is an application of a micro-needle patch.

13. A method for improved delivery of laser radiation for transbarrier therapeutic treatments according to claim 11, wherein said suitable means for delivery of therapeutic radiation is an optical fiber bundle optically connecting said radiation source to said newly formed micro pores.

14. A method for improved delivery of laser radiation for transbarrier therapeutic treatments according to claim 11, wherein said bio-compatible light-scattering fluid is composed of oil and water, with about 1 to 5 parts oil in a 100-part mixture.

15. A method for improved delivery of laser radiation for transbarrier therapeutic treatments according to claim 11, wherein said light-scattering, bio-compatible fluid is injected into said tissue through a micro-needle patch.

16. A method for improved delivery of laser radiation for transbarrier therapeutic treatments according to claim 11, wherein an optically transparent, bio-compatible dispersion fluid is administered after said light-scattering, bio-compatible fluid to disperse said light-scattering, bio-compatible fluid evenly throughout said treatment site.

17. A method for improved delivery of laser radiation for transbarrier therapeutic treatments according to claim 11, wherein said laser radiation is administered to said treatment site through a second micro-needle patch.

18. A method for improved delivery of laser radiation for transbarrier therapeutic treatments according to claim 11, wherein said laser radiation and said light-scattering, bio-compatible fluid are delivered through a same said micro-needle patch.