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WO2013052482A1 - Modular laser system for photodynamic therapy - Google Patents

Modular laser system for photodynamic therapy Download PDF

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Publication number
WO2013052482A1
WO2013052482A1 PCT/US2012/058459 US2012058459W WO2013052482A1 WO 2013052482 A1 WO2013052482 A1 WO 2013052482A1 US 2012058459 W US2012058459 W US 2012058459W WO 2013052482 A1 WO2013052482 A1 WO 2013052482A1
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WO
WIPO (PCT)
Prior art keywords
laser
light
sources
core unit
modules
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/US2012/058459
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French (fr)
Inventor
Thomas H. Foster
Timothy M. BARAN
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University of Rochester
Original Assignee
University of Rochester
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Filing date
Publication date
Application filed by University of Rochester filed Critical University of Rochester
Publication of WO2013052482A1 publication Critical patent/WO2013052482A1/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00Radiation therapy
    • A61N5/06Radiation therapy using light
    • A61N5/0613Apparatus adapted for a specific treatment
    • A61N5/062Photodynamic therapy, i.e. excitation of an agent
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00Radiation therapy
    • A61N5/06Radiation therapy using light
    • A61N5/067Radiation therapy using light using laser light
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00Radiation therapy
    • A61N2005/002Cooling systems
    • A61N2005/005Cooling systems for cooling the radiator
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00Radiation therapy
    • A61N5/06Radiation therapy using light
    • A61N2005/0626Monitoring, verifying, controlling systems and methods
    • A61N2005/0627Dose monitoring systems and methods
    • A61N2005/0628Dose monitoring systems and methods including a radiation sensor
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00Radiation therapy
    • A61N5/06Radiation therapy using light
    • A61N2005/063Radiation therapy using light comprising light transmitting means, e.g. optical fibres

Definitions

  • the present invention is directed to photodynamic therapy (PDT) of cancer and other localized diseases, such as macular degeneration, microbial infections, and acne.
  • PDT photodynamic therapy
  • the problems in the art include the lack of commercially available laser systems suitable for clinical photodynamic therapy and the lack of flexibility offered by the FDA-approved, commercially available systems. That situation is a major impediment to the more widespread adoption of PDT. In cancer applications, that lack of flexibility typically constrains physicians to work with Photofrin. Looking forward, as more PDT drugs become available, laser systems emitting one wavelength will impose a significant financial burden on PDT centers because each photosensitizer is optimally activated by a different laser wavelength. Thus, centers would be forced to purchase several expensive individual systems.
  • the present invention is directed to a system including a core unit and multiple interchangeable laser modules.
  • Each laser module preferably has multiple diode lasers and fibers that are fused or otherwise coupled into a single fiber.
  • each module may have a single diode laser, as there are commercial sources of diodes with a single output sufficient for some clinical applications.
  • An important aspect of the present invention is the ability to enable different modules to be controlled by a common core unit.
  • the present invention would enable a PDT center to purchase one system, with additional, relatively inexpensive plug-in laser modules available to deliver light at multiple clinically relevant wavelengths. That will greatly reduce the cost to the hospital or outpatient clinic and facilitate more widespread clinical dissemination of that important therapy. Because the user interface would be the same for each laser module, that single system would facilitate clinical acceptance by eliminating the need for technologists to learn to operate several different laser systems.
  • Figure 1 is a diagram of a laser module according to the preferred embodiment.
  • Figure 2 is a block diagram of a system using multiple laser modules of Figure 1.
  • the laser module 100 of Figure 1 comprises two or more commercially available diode lasers 102.
  • the number of those diodes is determined by the power emitted by each and the total power required for PDT treatment.
  • Each of those diode lasers 102 is equipped with a standard SMA optical fiber termination.
  • the output of each of the individual diodes is coupled to the fiber termination 104 of a leg 106 of a custom optical fiber in which the cores of the legs are fused at a fusion point 108 into a common 200 - 400 micron core diameter optical fiber 110 having a fiber termination 112.
  • a single diode laser 102 can be used instead if it has sufficient output for the purpose, in which case the fusion point 108 is not needed.
  • FIG. 1 Shown in Figure 1 is a bifurcated fused fiber optic arrangement, enabling the coupling of two diode lasers. More lasers can be added to increase the total power by creating a fused arrangement with more than two legs or by linking together a series of bifurcated fibers. The final output would be SMA coupled to the FDA-approved PDT treatment fiber. That part of the laser system can be packaged as a module. Those modules would be sold separately and would enable PDT to be performed at any desired treatment wavelength.
  • a system 200 for photodynamic therapy includes multiple laser modules 100a, 100b, 100c configured like the laser module 100 of Figure 1.
  • the laser modules 100a, 100b, 100c can include laser modules having different wavelength characteristics for use with different photosensitizers or other treatment modalities.
  • One or more of the laser modules 100a, 100b, 100c can be plugged into the core unit 202.
  • the core unit 202 is configured to allow such plugging in; otherwise, its construction will be familiar to those skilled in the art and will therefore not be described in detail here.
  • the user determines the type of photodynamic therapy to be performed, selects one or more of the laser modules 100a, 100b, 100c accordingly, plugs them into the core unit 202, and performs the photodynamic therapy.
  • the diode laser controller 204, the thermoelectric cooling controllers 206, and sensors 208 for measuring the power emitted from the treatment fiber are included in the core unit 202.
  • the laser controller and power measurement hardware are controlled by a laptop computer 210 or similar device (e.g., a netbook or tablet).
  • a touch pad interface could be used.
  • the software interface would be written to be easily operated by a clinical technologist. Plugging in the various laser modules would be straightforward using color coding or clearly marked ports on the housing of the core unit 202.
  • the laser diodes 102 all emit at the same wavelength and are coupled to increase the optical power into the downstream optical fiber 110.
  • Another variation of the preferred embodiment accommodates new photosensitizers for photodynamic therapy that are excited by near infrared laser light, namely, in the 700 - 800 nm range. Those wavelengths are not seen by the human eye and so can present a danger. It would therefore be preferable to implement some way to report to the user that the device is on and emitting near infrared light.
  • one or more of the diodes 102 can be near infrared, but one can be a different wavelength - a visible wavelength (such as blue, green, red) - which would serve as an indicator that the system was on and emitting the near infrared. That additional wavelength would be "piped" down the fiber but would not interfere with the PDT light dose for two reasons: (1) it could be very low power but still visible at the end of the fiber, and (2) its emission would not correspond to the absorption of the photosensitizer.
  • a visible wavelength such as blue, green, red
  • a system can be made up of replicates of the elements described above. That is, the core elements would be the same as disclosed above, but such a system would incorporate a number of them, each delivering light to a different treatment fiber. Therefore, the present invention should be construed as limited only by the appended claims.

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  • Health & Medical Sciences (AREA)
  • Biomedical Technology (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Pathology (AREA)
  • Radiology & Medical Imaging (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Physics & Mathematics (AREA)
  • Optics & Photonics (AREA)
  • Biophysics (AREA)
  • Radiation-Therapy Devices (AREA)

Abstract

A system for photodynamic therapy has a core system and a modular laser system that the user can select to provide light at the appropriate wavelength. The modular laser system has one or more diode lasers and fibers; in the case of multiple diode lasers, the fibers are fused or otherwise coupled into a single fiber.

Description

MODULAR LASER SYSTEM FOR PHOTODYNAMIC THERAPY Reference to Related Application
[0001] The present application claims the benefit of U.S. Provisional Patent Application No.
61/542,445, filed October 3, 2011, whose disclosure is hereby incorporated by reference in its entirety into the present disclosure.
Statement of Government Interest
[0002] This invention was made with government support under Grant Nos. CA68409 and CA55791 awarded by National Institutes of Health. The government has certain rights in the invention.
Field of the Invention
[0003] The present invention is directed to photodynamic therapy (PDT) of cancer and other localized diseases, such as macular degeneration, microbial infections, and acne.
Description of Related Art
[0004] FDA-approved, commercially available lasers for PDT deliver light at one wavelength, which is typically suitable for the activation of one or at most two photosensitizers. That places unacceptable limits on clinical research, where it is often desirable to investigate several different photosensitizers, each of which absorbs light optimally at a different laser wavelength. When those photosensitizers achieve FDA approval, current designs require a separate laser dedicated to each photosensitizer, which creates a significant cost barrier to widespread adoption of PDT.
[0005] The problems in the art include the lack of commercially available laser systems suitable for clinical photodynamic therapy and the lack of flexibility offered by the FDA-approved, commercially available systems. That situation is a major impediment to the more widespread adoption of PDT. In cancer applications, that lack of flexibility typically constrains physicians to work with Photofrin. Looking forward, as more PDT drugs become available, laser systems emitting one wavelength will impose a significant financial burden on PDT centers because each photosensitizer is optimally activated by a different laser wavelength. Thus, centers would be forced to purchase several expensive individual systems.
Summary of the Invention
[0006] It is therefore an object of the invention to overcome that difficulty. To achieve the above and other objects, the present invention is directed to a system including a core unit and multiple interchangeable laser modules. Each laser module preferably has multiple diode lasers and fibers that are fused or otherwise coupled into a single fiber. Alternatively, each module may have a single diode laser, as there are commercial sources of diodes with a single output sufficient for some clinical applications. An important aspect of the present invention is the ability to enable different modules to be controlled by a common core unit.
[0007] The present invention would enable a PDT center to purchase one system, with additional, relatively inexpensive plug-in laser modules available to deliver light at multiple clinically relevant wavelengths. That will greatly reduce the cost to the hospital or outpatient clinic and facilitate more widespread clinical dissemination of that important therapy. Because the user interface would be the same for each laser module, that single system would facilitate clinical acceptance by eliminating the need for technologists to learn to operate several different laser systems.
Brief Description of the Drawings
[0008] A preferred embodiment of the present invention will be set forth in detail with reference to the drawings, in which:
[0009] Figure 1 is a diagram of a laser module according to the preferred embodiment; and
[0010] Figure 2 is a block diagram of a system using multiple laser modules of Figure 1.
Detailed Description of the Preferred Embodiment
[0011] A preferred embodiment and variations thereof will be described in detail with reference to the drawings, in which like reference numerals refer to like elements throughout.
[0012] The laser module 100 of Figure 1 comprises two or more commercially available diode lasers 102. The number of those diodes is determined by the power emitted by each and the total power required for PDT treatment. Each of those diode lasers 102 is equipped with a standard SMA optical fiber termination. The output of each of the individual diodes is coupled to the fiber termination 104 of a leg 106 of a custom optical fiber in which the cores of the legs are fused at a fusion point 108 into a common 200 - 400 micron core diameter optical fiber 110 having a fiber termination 112. As noted above, a single diode laser 102 can be used instead if it has sufficient output for the purpose, in which case the fusion point 108 is not needed.
[0013] Shown in Figure 1 is a bifurcated fused fiber optic arrangement, enabling the coupling of two diode lasers. More lasers can be added to increase the total power by creating a fused arrangement with more than two legs or by linking together a series of bifurcated fibers. The final output would be SMA coupled to the FDA-approved PDT treatment fiber. That part of the laser system can be packaged as a module. Those modules would be sold separately and would enable PDT to be performed at any desired treatment wavelength.
[0014] As shown in Figure 2, a system 200 for photodynamic therapy includes multiple laser modules 100a, 100b, 100c configured like the laser module 100 of Figure 1. The laser modules 100a, 100b, 100c can include laser modules having different wavelength characteristics for use with different photosensitizers or other treatment modalities. One or more of the laser modules 100a, 100b, 100c can be plugged into the core unit 202. The core unit 202 is configured to allow such plugging in; otherwise, its construction will be familiar to those skilled in the art and will therefore not be described in detail here. In use, the user determines the type of photodynamic therapy to be performed, selects one or more of the laser modules 100a, 100b, 100c accordingly, plugs them into the core unit 202, and performs the photodynamic therapy.
[0015] The diode laser controller 204, the thermoelectric cooling controllers 206, and sensors 208 for measuring the power emitted from the treatment fiber are included in the core unit 202. In one variation, the laser controller and power measurement hardware are controlled by a laptop computer 210 or similar device (e.g., a netbook or tablet). Alternatively, a touch pad interface could be used. The software interface would be written to be easily operated by a clinical technologist. Plugging in the various laser modules would be straightforward using color coding or clearly marked ports on the housing of the core unit 202.
[0016] In one variation of the preferred embodiment, the laser diodes 102 all emit at the same wavelength and are coupled to increase the optical power into the downstream optical fiber 110. Another variation of the preferred embodiment accommodates new photosensitizers for photodynamic therapy that are excited by near infrared laser light, namely, in the 700 - 800 nm range. Those wavelengths are not seen by the human eye and so can present a danger. It would therefore be preferable to implement some way to report to the user that the device is on and emitting near infrared light. So, again referring to Fig 1, one or more of the diodes 102 can be near infrared, but one can be a different wavelength - a visible wavelength (such as blue, green, red) - which would serve as an indicator that the system was on and emitting the near infrared. That additional wavelength would be "piped" down the fiber but would not interfere with the PDT light dose for two reasons: (1) it could be very low power but still visible at the end of the fiber, and (2) its emission would not correspond to the absorption of the photosensitizer.
7] While a preferred embodiment and variations thereof have been disclosed above, those skilled in the art who have reviewed the present disclosure will readily appreciate that other embodiments can be realized within the scope of the invention. For example, recitations of specific dimensions as well as of specific photosensitizers are illustrative rather than limiting. Also, the two legs can be combined into a single fiber by any suitable fiber-optic coupler or beam combiner, such as those known in the art. Furthermore, if only a single wavelength is needed, and a sufficiently powerful laser source exists, a module can include only one such laser source. Moreover, references to the FDA should be understood to extend, mutatis mutandis, to regulatory bodies in other countries. In addition, there are clinical applications in which laser light is delivered to an array of treatment fibers. In such a case, a system can be made up of replicates of the elements described above. That is, the core elements would be the same as disclosed above, but such a system would incorporate a number of them, each delivering light to a different treatment fiber. Therefore, the present invention should be construed as limited only by the appended claims.

Claims

What is claimed is:
1. A laser module for photodynamic therapy, the module comprising:
a plurality of laser light sources;
a plurality of optical fiber legs, each optically coupled to one of the sources to receive light from said one of the sources; and
a single optical fiber to which all of the plurality of optical fiber legs are optically coupled or fused at one end of said single optical fiber to receive the light from the sources.
2. The module of claim 1, wherein the plurality of laser light sources comprise:
a laser light source for outputting light in an infrared wavelength; and
a laser light source for outputting light in a visible wavelength.
3. The module of claim 1, wherein the plurality of laser sources comprise two laser sources outputting light at wavelengths suitable to activate two different photosensitizers simultaneously.
4. The module of claim 1, wherein the plurality of laser sources comprise:
one laser outputting light at a wavelength and power appropriate for exciting photosensitizer fluorescence for spectroscopy and/or imaging; and
two or more lasers outputting light at a wavelength and power appropriate for the photodynamic therapy.
5. A modular laser system for photodynamic therapy, the system comprising:
a core unit for controlling the photodynamic therapy; and a plurality of laser modules for emitting laser light under control of the core unit, the plurality of laser modules being configured to be interchangeably attached to the core unit to emit the laser light under the control of the core unit to perform the photodynamic therapy.
6. The modular laser system of claim 5, wherein each of the plurality of laser modules comprises:
a plurality of laser light sources;
a plurality of optical fiber legs, each optically coupled to one of the sources to receive light from said one of the sources; and
a single optical fiber to which all of the plurality of optical fiber legs are optically coupled or fused at one end of said single optical fiber to receive the light from the sources.
7. The modular laser system of claim 6, wherein, in each of the plurality of laser modules, the plurality of laser light sources comprise:
a laser light source for outputting light in an infrared wavelength; and
a laser light source for outputting light in a visible wavelength.
8. The modular laser system of claim 6, wherein, in each of the plurality of laser modules, the plurality of laser sources comprise two laser sources outputting light at wavelengths suitable to activate two different photosensitizers simultaneously.
9. The modular laser system of claim 6, wherein, in each of the plurality of laser modules, the plurality of laser sources comprise:
one laser outputting light at a wavelength and power appropriate for exciting photosensitizer fluorescence for spectroscopy and/or imaging; and two or more lasers outputting light at a wavelength and power appropriate for the photodynamic therapy.
10. The modular laser system of claim 5, wherein the plurality of laser modules comprises laser modules having different wavelength characteristics.
11. The modular laser system of claim 5, wherein the core unit comprises:
a laser controller for controlling a laser in at least one of the laser modules when said at least one one of the laser modules is attached to the core unit;
a cooling controller for cooling the system; and
a sensor for sensing a power of the emitted laser light.
12. The system of claim 5, wherein the core unit comprises an interface for controlling the system.
13. A method for performing photodynamic therapy, the method comprising:
(a) providing a system for performing photodynamic therapy, the system comprising: a core unit for controlling the photodynamic therapy ; and
a plurality of laser modules for emitting laser light under control of the core unit, the plurality of laser modules being configured to be interchangeably attached to the core unit to emit the laser light under the control of the core unit to perform the photodynamic therapy;
(b) selecting at least one of the plurality of laser modules for suitability to the photodynamic therapy;
(c) installing said at least one of the plurality of laser modules selected in step (b) into the core unit; and (d) performing the photodynamic therapy with the core unit and said at least one of the plurality of laser modules.
14. The method of claim 13, wherein each of the plurality of laser modules comprises: a plurality of laser light sources;
a plurality of optical fiber legs, each optically coupled to one of the sources to receive light from said one of the sources; and
a single optical fiber to which all of the plurality of optical fiber legs are optically coupled or fused at one end of said single optical fiber to receive the light from the sources.
15. The method of claim 14, wherein, in each of the plurality of laser modules, the plurality of laser light sources comprise:
a laser light source for outputting light in an infrared wavelength; and
a laser light source for outputting light in a visible wavelength.
16. The method of claim 15, further comprising determining whether the system is operating by observing the light in the visible wavelength.
17. The method of claim 14, wherein, in each of the plurality of laser modules, the plurality of laser sources comprise two laser sources outputting light at wavelengths suitable to activate two different photosensitizers simultaneously.
18. The method of claim 14, wherein, in each of the plurality of laser modules, the plurality of laser sources comprise: one laser outputting light at a wavelength and power appropriate for exciting photosensitizer fluorescence for spectroscopy and/or imaging; and
two or more lasers outputting light at a wavelength and power appropriate for the photodynamic therapy.
19. The method of claim 13, wherein the plurality of laser modules comprises laser modules having different wavelength characteristics.
20. The method of claim 13, wherein the core unit comprises:
a laser controller for controlling a laser in at least one of the laser modules when said at least one one of the laser modules is attached to the core unit;
a cooling controller for cooling the system; and
a sensor for sensing a power of the emitted laser light.
21. The method of claim 13, wherein the core unit comprises an interface for controlling the system.
PCT/US2012/058459 2011-10-03 2012-10-02 Modular laser system for photodynamic therapy Ceased WO2013052482A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201161542445P 2011-10-03 2011-10-03
US61/542,445 2011-10-03

Publications (1)

Publication Number Publication Date
WO2013052482A1 true WO2013052482A1 (en) 2013-04-11

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Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ITUA20163480A1 (en) * 2016-05-16 2017-11-16 Winform Medical Eng S R L Improved medical device for laser therapy.
DE102023004549A1 (en) 2023-11-07 2025-05-08 Biolitec Research Gmbh DEVICE AND METHOD FOR THE TREATMENT OF DYSPLASIA
DE102023004548A1 (en) 2023-11-07 2025-05-08 Biolitec Research Gmbh Device and method for treating tumors
WO2025098655A1 (en) * 2023-11-07 2025-05-15 Biolitec Holding Gmbh & Co Kg Device for treating dysplasia, tumours and/or bacterial and viral infections

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4479499A (en) * 1982-01-29 1984-10-30 Alfano Robert R Method and apparatus for detecting the presence of caries in teeth using visible light
US5304167A (en) * 1988-11-10 1994-04-19 Premier Laser Systems, Inc. Multiwavelength medical laser method
US20040133191A1 (en) * 2002-12-27 2004-07-08 Masayuki Momiuchi Laser device for medical treatment system
US20060224148A1 (en) * 2005-04-05 2006-10-05 Cho George E System and method for laser lipolysis
US20080221647A1 (en) * 2007-02-23 2008-09-11 The Regents Of The University Of Michigan System and method for monitoring photodynamic therapy
WO2011072472A1 (en) * 2009-12-14 2011-06-23 武汉奇致激光技术有限公司 Multifunctional laser therapeutic apparatus

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4479499A (en) * 1982-01-29 1984-10-30 Alfano Robert R Method and apparatus for detecting the presence of caries in teeth using visible light
US5304167A (en) * 1988-11-10 1994-04-19 Premier Laser Systems, Inc. Multiwavelength medical laser method
US20040133191A1 (en) * 2002-12-27 2004-07-08 Masayuki Momiuchi Laser device for medical treatment system
US20060224148A1 (en) * 2005-04-05 2006-10-05 Cho George E System and method for laser lipolysis
US20080221647A1 (en) * 2007-02-23 2008-09-11 The Regents Of The University Of Michigan System and method for monitoring photodynamic therapy
WO2011072472A1 (en) * 2009-12-14 2011-06-23 武汉奇致激光技术有限公司 Multifunctional laser therapeutic apparatus

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ITUA20163480A1 (en) * 2016-05-16 2017-11-16 Winform Medical Eng S R L Improved medical device for laser therapy.
EP3246069A1 (en) 2016-05-16 2017-11-22 Winform Medical Engineering S.r.l. Improved medical device for laser therapy
DE102023004549A1 (en) 2023-11-07 2025-05-08 Biolitec Research Gmbh DEVICE AND METHOD FOR THE TREATMENT OF DYSPLASIA
DE102023004548A1 (en) 2023-11-07 2025-05-08 Biolitec Research Gmbh Device and method for treating tumors
WO2025098655A1 (en) * 2023-11-07 2025-05-15 Biolitec Holding Gmbh & Co Kg Device for treating dysplasia, tumours and/or bacterial and viral infections

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