WO2009121158A2 - Dispositif photobiomodulateur pour la prévention et le traitement de traumatismes mammaires et de lésions non infectieuses des mamelles - Google Patents

Dispositif photobiomodulateur pour la prévention et le traitement de traumatismes mammaires et de lésions non infectieuses des mamelles Download PDF

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Publication number
WO2009121158A2
WO2009121158A2 PCT/BR2009/000100 BR2009000100W WO2009121158A2 WO 2009121158 A2 WO2009121158 A2 WO 2009121158A2 BR 2009000100 W BR2009000100 W BR 2009000100W WO 2009121158 A2 WO2009121158 A2 WO 2009121158A2
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WIPO (PCT)
Prior art keywords
injuries
ceiling
treatment
prevention
infectious
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PCT/BR2009/000100
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English (en)
Portuguese (pt)
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WO2009121158A3 (fr
Inventor
Angélica RODRIGUES DE ARAÚJO
Sara Del-Vecchio
Maurício FERRARI SANTOS CORRÊA
Lívio DE BARROS SILVEIRA
Alexandre GONÇALVES TEIXEIRA
Marcos Pinotti Barbosa
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Universidade Federal De Minas Gerais - Ufmg
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Application filed by Universidade Federal De Minas Gerais - Ufmg filed Critical Universidade Federal De Minas Gerais - Ufmg
Publication of WO2009121158A2 publication Critical patent/WO2009121158A2/fr
Publication of WO2009121158A3 publication Critical patent/WO2009121158A3/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/06—Radiation therapy using light
    • A61N5/0613—Apparatus adapted for a specific treatment

Definitions

  • the present invention discloses a device utilizing photobiostimulation principles for the treatment of nipple trauma (fissures and cracks) for use in clinical and home environments to assist the healing process of uninfected nipple injuries and minimize the sequelae (pain and impediment to breastfeeding) arising from these conditions.
  • This device can also be used in veterinary medicine, for prevention and treatment of teat injuries, with the function of preventing traumatic teat injuries resulting from the milking process (manual or mechanical) and to treat uninfected teat injuries, minimizing sequelae due to these conditions (pain, impaired milking, reduced milk production, changes in physicochemical composition and milk quality as well as economic costs and losses).
  • Milk is considered the noblest of foods for its rich composition of protein, fat, carbohydrates, minerals and vitamins. In addition to its nutritional properties, milk provides low cost nutrients and immune protection for the newborn and offers anticarcinogenic elements present in fat such as conjugated linoleic acid, sphingomyelin, butyric acid, D-carotene, vitamins A and D ( MULLER, 2002) Due to these characteristics, the agro-industrial milk system has enormous social importance, being one of the most important in the country (OLIVEIRA et al., 1999).
  • Dairy activity is practiced nationwide on more than one million farms and, in primary production alone, generates more than three million jobs, adding more than six billion to the value of national agricultural production (VILELA et al., 2002).
  • mastitis KITCHEN, 1981; SCH ⁇ ELLIBAUM, 2000.
  • This is one of the most complex and costly conditions affecting dairy animals due to its high prevalence (it is estimated that 17-20% of the world's dairy cow population has mastitis in at least one quarter of the udder) and economic and social damage it entails (BRANT and FIGUEIREDO, 1994).
  • Mastitis may also compromise public health through the delivery of pathogenic microorganisms to the consumer.
  • mastitis is of concern because it aggravates social problems such as malnutrition, child mortality and hunger (COSTA, s.d.-A; COSTA, s.d.-B.).
  • mastitis The etiology of mastitis is complex and multivariate, which makes it necessary to develop programs to control and, especially, prevent the disease (HURLEY and MORIN, sd).
  • main control measures are the monitoring of mastitis rates, pre and post immersion of the ceilings in antiseptic solution, environmental comfort, the treatment of animals when drying, the medical treatment of clinical cases, the disposal of animals. with chronic infections and the hygiene, management and maintenance of milking equipment (CULLOR, 1983; PHILPOT & NICKERSON, 1991; NICKERSON et al., 1995; NICKERSON, 1998; HILLERTON, 1996; MULLER, 1999; FONSECA and SANTOS, 2000).
  • the roof channel represents an important line of defense of the body against infections (GIRAUDO, 1996).
  • This canal is normally closed by a muscle ring (roof sphincter) in the period between milks, and is blocked by a keratin plug derived from the canal wall cells.
  • This keratin has antimicrobial activity, but its main function is to act as a physical barrier against pathogenic microorganisms (JONES and BAILEY, 1998). Milking or sucking removes this plug and makes the sphincter flaccid, making the roof canal more susceptible to infections for up to two hours. After this, the muscle tends to regain its tone and the keratin plug is formed again. (EMPTY, sd).
  • VAZ caustic and milking chemicals with excess vacuum or excessively rapid pulsation
  • Changes in roof condition may occur in the short, medium and long term (MEIN et al, 2001; REINEMANN, s.d.).
  • Short-term changes in the condition of the ceilings such as: 1- color changes (rosy to reddish or bluish), 2- volume (enlargement), 3- shape (flexible and malleable to rigid), 4- degree of hole opening teat usually occur in response to the milking process itself.
  • the roof may take up to a few hours to fully recover its integrity. Failures in the machine or the management of milking and / or the intervals between them are considered primary causes of exacerbation of short-term changes in roof condition (MEIN et al, 2001).
  • Medium-term changes refer to tissue changes and vascular damage (petechial or large-scale hemorrhages) of the roof that become visible within a few days or weeks. These may be due to milking (failure in pulsation, vacuum and overordination), chemical action (stiffness and loss of elasticity) on the roof or adverse weather conditions (flaky and dry skin due to decreased hydration). These conditions may interrelate favoring the appearance of cracks and / or cracking of the ceiling, especially in its distal portion (MEIN et al, 2001).
  • tissue radiation with light sources such as LASER's - Light Amplification by Stimulated Emission of Radiation
  • LED Light Emitting Diode
  • the effects of photobiomodulatory therapy are due to the absorption of light by chromophores present in cells such as cytochrome-C oxidase present in mitochondria (KARL) et al., 2004).
  • LASER and low intensity LED have been observed in conditions such as osteoarthritis, radiculopathies, tendonitis and especially in the treatment of skin wounds.
  • animals KANA et al, 1981; SOARES et al, 1989; MATERA et al, 2003
  • humans CORR ⁇ A et al, 2003; SIQUEIRA et al, 2004
  • Increased ATP production, stimulation of proliferation and action of fibroblasts and epithelial cells as well as local microcirculation are some of the main physiological justifications for the use of light radiation for healing therapy (MESTER, 1974; CASTRO et al. 1983; BAXTER, 1994; WEISS et al., 2005; VINCK et al., 2003).
  • Tatarunas et al. evaluated the action of LASER As-Ga, 904 nm, on feline skin surgical wounds.
  • the application was performed punctually, with the pen kept perpendicular and slightly contacting the wound.
  • the applications were made at 2, 4, 8 and 15 th day post-operative ovariohysterectomy.
  • the study concluded that LASER As-Ga at 2 and 4 J / cm 2 dosages had a positive effect on the first intention healing of feline skin surgical wounds, and the dose of 2 J / cm 2 was advantageous over 4 J / cm 2 .
  • US05958966 describes a device and method for treating prostate cancer based on photostimulation, and involves an antibody that is bound to the prostate antigen.
  • US06881405 describes biomodulators, which regulate cell differentiation and proliferation, as well as methods of use for treating various pathological conditions, such as cancer, immune disorder and vascular diseases; stimulate tissue healing after injury; for vaccinations; stimulate the production of important molecules; and produce vascular flaps for transplants.
  • US06933287 describes a method for treating tumor with radiation in which the tumor is sensitized by a tumor sensitizing agent.
  • the design of the photobiomodulator device took into consideration the morphology and anatomy of the human breast, adding comfort to the user during application and the possibility of use in different breast shapes and sizes, since the positioning unit can be anatomically adjusted to the breast. .
  • the morphology and anatomy of the roofs were considered, which allows their application in different ceiling sizes, adding ease of handling and operation to the responsible professional.
  • the equipment can be made of sterilizable material, which allows and favors proper asepsis for each application. This fact is of fundamental importance for the control and prevention of infections, especially when it comes to open wounds. Additionally, for human application, it is possible to fix the device over the breast by means of anatomically adjustable support to the upper trunk, made of anti-allergic and washable material, which favors the positioning of the photobiomodulator device and facilitates its application.
  • the practicality of the equipment together with the possibility of use in the home environment, besides the clinical (both under the supervision and physical therapy guidance), contribute to the patient's greater adherence to treatment, which indirectly favors better results in pain control. and tissue healing.
  • the photobiomodulator device is based on the principles of photobiostimulation, already established in the literature (MESTER et al., Laser stimulation of wound healing, 1974; KARU, Fundamental Photobiological of low-power laser therapy, 1987; Harris, Biomolecular Mechanisms of LASER biostimulation, 1991; WHELA et al., Medical applications of space-emitting diode technology-space station and beyond, 1999; ORTIZ et al., Low-intensity laser: effects on biological tissues, 2001; WHELAN et al., Light Emitting Diode Medical Application from deep space to deep sea, 2001; KARU et al, Photobiological modulation of cell attachment via cytochrome and oxidase, 2004; KARU; KOLYAKOV, Exact Action spectra of cellular responses relevant to phototherapy, 2005; WEISS et al., Clinical experience with light-emitting diode (LED) photomodulation, 2005).
  • light sources with wavelengths in the non-restrictive near-infrared near-infrared spectral range are able to modulate the activity of biological cells in injured tissues.
  • These sources can be polarized or non-polarized, flat or spherical, coherent or non-coherent, continuous or pulsating, non-restrictive. They can compose an optical / mechanical configuration suitable for obtaining the optical parameters required for biostimulation, using optical elements such as lenses, mirrors, beam splitters, among others.
  • the resulting radiation emitted by the photobiomodulator device must not be capable of raising the temperature of biological tissues to levels sufficient to induce thermophysiological responses (LANZAFAME et al., Temperature-controlled 830nm Low Laser Therapy of Experimental Pressure Ulcers, 2004) and goggles with a specific wavelength filter emitted by the photobiomodulator device should be worn by the wearer and healthcare professional during application to prevent possible eye damage.
  • Light intensity / wattage, wavelength, application time, frequency, pulse mode, treatment time, and other parameters can be controlled to meet different mode treatment patterns. optimize device application.
  • the time control can be performed via timer, or built-in microcontrolled system, or electronic devices or by a communication interface with microcomputer.
  • the intensity can be adjusted by selecting the light emission mode and / or the number of light sources to be used for the application.
  • Figure 1 shows the assembled device with the cylindrical shaped body configuration.
  • Figure 2 shows the device assembled with the conical shaped body configuration.
  • Figure 3 shows the front view of the breast positioning unit for cylindrical and conical configurations.
  • Figure 5 shows, (a) is the front view and (b) is the top view.
  • Figures 4, 6, 7, 8, 9 and 10 show the following views: in (a) front view of the complete device; (b) sectional view shown in (a); (c) top view and (d) front view of the device without the protection unit. When necessary they also have the side view at (a) and an auxiliary section on the lighting unit at (d).
  • Device components must be made in such a way as to withstand the aseptic process as well as the impacts of animal movement during device application.
  • the photobiomodulator device may be mounted in appropriate, non-restrictive configurations such as cylindrical shaped body ( Figure 1) and / or conical shaped body ( Figure 2). Either configuration will consist of a main body, subdivided into three main, non-restrictive units, the light-emitting unit (1), the breast positioning unit (2) and the control unit (3).
  • the light-emitting unit (1) comprises the light source (s) that will emit the light intensity at the wavelengths required for biostimulation as well as other possible optical elements as described above. It can be composed of light sources that emit light in the wavelengths required for treatment, of any kind as LED (in Portuguese, light emitting diode), laser, incandescent, fluorescent, among others, not restrictive. This unit is driven by the control unit (3).
  • the breast positioning unit (2) may be conical (Figure 3A) or circular ( Figure 3B) or other geometry that is favorable for the positioning of the photobiomodulator device in the human breast, thus avoiding discomfort for the users.
  • the inner surface of the breast positioning unit (2) may be appropriately coated and / or trimmed (eg mirrored, opaque) in order to allow the best direction of light rays to the injured tissue, optimizing the device efficiency during biostimulation.
  • one or more temperature sensors / transducers may be installed, preferably along the periphery of the positioning unit (2).
  • the technology used for the temperature sensor / transducer may be thermocouple, thermistor, electrical resistance, fiber optic sensor or other non-restrictive light modulating effect. It may also be desirable to measure other quantities such as light intensity, tissue impedance, and imaging during device application for greater control and safety during applications.
  • sensors / transducers may be used to measure light intensity and / or tissue impedance and / or micro-cameras coupled to the positioning unit (2).
  • the information obtained by these sensors, such as images, can be used to study the area of injuries and monitor the evolution of the healing process of nipple trauma.
  • the control unit (3) is responsible for the operation of the photobiomodulator device, activating the light emitting unit (1) when necessary. It consists of an electro-electronic circuit divided into three blocks: ("A") power supply; ("B”) flag and (“C”) control and timer, whose functions are described below.
  • Block “A” refers to the power supply responsible for providing the other blocks with the proper voltage for equipment operation.
  • This block can be implemented using energy storage elements (such as batteries, batteries, etc.) or by transforming the power supplied by the utility and / or generators to match the power to the needs of the device.
  • Block “B” is responsible for signaling, visual and / or sound indicating whether the equipment is energized, is emitting light and the possible termination of the application time. This can consist of liquid crystal display and / or LED and / or beep.
  • Block “C” is responsible for controlling the light emission, allowing the choice of the previously selected light emission mode.
  • This block may also be responsible for counting the application time. In this way, a programmable timer will be able to count (increasing and / or decreasing), record the exposure time and send to block "B" the moment of the end of the count.
  • This block may also have the interface for computer communication, which may receive the operating parameters of the device, for example, application time and emission mode, as well as being able to acquire sensor / transducer signals (temperature, intensity luminance, tissue impedance and image) and can store this data for further processing.
  • the device thus constituted, has a number of characteristics considered appropriate and advantageous from the point of view of providing a noninvasive treatment for nipple trauma, without direct contact with the injured region and of proven efficacy in pilot studies (ARA ⁇ JO et al, Development of a led cluster device able to treat mammila injury emitting in the infrared wavelength, 2007), bringing as main benefits the pain control and the improvement of the tissue healing process.
  • the photobiomodulator device can also be mounted in appropriate configurations that best suit the anatomy of the ceiling and the type and location of the lesion, the type of material to be made and the type of attachment to the ceiling, such as cylindrical tubular shaped body. , base rounded ( Figure 4) or straight ( Figures 5 to 10), circular cross section, or other favorable, non-restrictive geometry.
  • any of the configurations will be comprised of a main body, subdivided into three non-restrictive main units: (1) the light-emitting unit shown with configurations exemplified in non-restrictive Figures 4d, 6d, 7d, 8d, 9d and 10d; (2) the primary ceiling positioning and fixing unit comprising the upper portion of the device; and (3) the control unit, which will be separate from previous units. Also for any of the described configurations can be used a single main body, applying one roof at a time or a structure composed of several bodies, allowing the application of the treatment concurrently on all roofs of the animal, as for example, the one shown in Figure 5, not restrictive.
  • the light-emitting unit (1) comprises the light source (s) which will emit the light intensity at the wavelengths in the non-restrictive near-infrared red spectrum and intensity / power required for biostimulation as well as other possible optical elements as described above.
  • the light sources will be arranged radially throughout the main body, or in any other position that is appropriate to the anatomy of the roof, the type and location of the lesion, the emission parameters and the type of geometry chosen. They may be fixed along the same cross-sectional line ( Figures 6 and 7) or interleaved therein ( Figures 4,5,8,9 and 10), not restrictive. Light sources may be located on all body surfaces, including the base ( Figure 4), or only on the non-restrictive side surfaces ( Figures 5 to 10).
  • the fixation of the light sources can be done in different ways, arranged in an auxiliary set (4), which will be fixed to the main body of Figure 4, or directly to the main body itself (5) of Figure 6 and also to the others, or any other type of mounting that best suits the characteristics of the light source and geometry used. It can be composed of light sources that emit light in the wavelengths required for treatment, of any kind as LED, LASER, incandescent, fluorescent, optical fiber, non-restrictive. The number of light sources, their positioning and activation as well as the wavelength (s) to be used may be combined to best suit the desired treatment.
  • This unit is operated by the control unit (3) together or independently for certain groups of light sources.
  • the inner surface of the emitting unit (1) may be properly coated and / or trimmed (such as mirrored or opaque) to provide the best possible directing light rays to the injured tissue, optimizing device efficiency during photostimulation.
  • the emitting unit may include a protection unit which shall ensure the integrity of the electrical connections as well as the light sources themselves during the handling of the device, such as that presented by item (6) in Figures 4, 6, 7, 8, 9 and 10.
  • This protection unit will follow the geometry of the main units and can be fixed by means of a welded threaded joint ( Figure 4), when dealing with metallic or polymeric bodies, by snapping, snapping or other appropriate type of fixation. to other materials. It can be attached to the ceiling fixing system itself, which may be part of the main body ( Figures 6, 7, 8 and 9) or be a separate component thereof ( Figures 4 and 10). Attachment of these units can also be accomplished with the aid of an outer ring (9) to them as, for example, illustrated in Figures 9 and 10, or other more suitable configuration.
  • the protection unit also aims to ensure the safety of the device applicator and the animal itself from possible electrical breakdowns.
  • the roof positioning and positioning unit (2) may have shapes with conical section (7) of Figure 7 or straight (8) in Figures 5,6,8,9 and 10, or other geometry that is favorable for positioning the photobiomodulator device at the upper end of the roof, thus avoiding animal discomfort and stress during application of the device as well as other injuries to the ceiling.
  • This unit can be made of polymeric, antiallergic and sterilizable material to ensure the fixation and correct positioning of the device. As stated above, this unit may be made integral with the main body, forming a single body, or independently, and then mounted on the main body according to the material and manufacturing process to be used.
  • An external auxiliary apparatus for supporting and attaching the device to the ceiling may be made by contemplating the attachment of the device to another portion of the animal's body or to any apparatus inherent in the milking process or the common animal environment, where possible. In other cases, the vacuum system inherent to the milking process can even be used to fix the device and the device must be modified. necessary to ensure system integrity and system utilization.
  • the intensity / power adjustment may be made by selecting the light emission mode and / or the number of light sources to be used for the non-restrictive application, which will be interrelated to the control of the other parameters as described below. .
  • the selection of wavelength (s) may be made by activating a particular light source or a group of sources which have the wavelength (s) required for the treatment, not restrictive.
  • a combination of different wavelengths can be used to ensure treatment efficiency and optimization, as this will allow several cells involved in the repair process to be stimulated together.
  • Pulse parameters, when using pulsed light may be controlled electronically from non-restrictive digital logic and / or integrated circuits.
  • the time control can be performed via timer, or built-in microcontrolled system, or electronic devices or by a communication interface with microcomputer.
  • a system indicative of the operation of the source (s), visual and / or auditory, will assist the user about the time required for the application as well as alert to the correct operation of the device.
  • a system indicative of the amount of charge of the power source used, visual and / or auditory will control the use of the device.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Pathology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Radiology & Medical Imaging (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Radiation-Therapy Devices (AREA)

Abstract

La présente invention concerne un dispositif faisant appel aux principes de la photobiostimulation pour le traitement de traumatismes mammaires (fissures et crevasses), utilisable dans des environnements clinique et domestique en vue de favoriser le processus de cicatrisation tissulaire de lésions mammaires non infectées et de réduire les conséquences de ces affections (douleur et impossibilité de pratiquer l'allaitement). Ce dispositif peut également être utilisé en médecine vétérinaire pour la prévention et le traitement de lésions des mamelles, en vue de prévenir les lésions traumatiques des mamelles résultant de l'opération de traite (manuelle ou mécanique) et de traiter les lésions non infectées des mamelles, réduisant ainsi les conséquences de ces affections (douleur, impossibilité de réaliser la traite, réduction de la production laitière, modifications de la composition physico-chimique et de la qualité du lait, coûts et pertes économiques).
PCT/BR2009/000100 2008-04-01 2009-04-01 Dispositif photobiomodulateur pour la prévention et le traitement de traumatismes mammaires et de lésions non infectieuses des mamelles WO2009121158A2 (fr)

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BRPI0801418 2008-04-01
BR014090001516 2009-03-30

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Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8651112B2 (en) 1998-11-30 2014-02-18 David McDaniel Process for treatment of psoriasis
US8651111B2 (en) 2003-04-10 2014-02-18 David H. McDaniel Photomodulation methods and devices for regulating cell proliferation and gene expression
US9192780B2 (en) 1998-11-30 2015-11-24 L'oreal Low intensity light therapy for treatment of retinal, macular, and visual pathway disorders
US9227082B2 (en) 1998-11-30 2016-01-05 L'oreal Method and apparatus for acne treatment using low intensity light therapy
US9814906B2 (en) 1998-11-30 2017-11-14 L'oreal Method and apparatus for skin treatment
WO2021151167A1 (fr) * 2020-01-31 2021-08-05 Cosmoaesthetics Pty Ltd Appareil pouvant être porté sur soi pour le traitement d'une mastite

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP4739202B2 (ja) 2003-07-31 2011-08-03 ジェントルウェイブス エルエルシー 熱傷、創傷、および関連皮膚疾患の光力学治療のためのシステムおよび方法

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5766222A (en) * 1997-07-07 1998-06-16 Petit; Michael G. Nipple illuminator for photodynamic therapy
US20050197681A1 (en) * 2004-02-06 2005-09-08 Lumiphase Inc. Method and device for the treatment of mammalian tissues
DE102005047517A1 (de) * 2004-10-03 2006-06-14 Stefan Bernhard Vorrichtung zur Prävention und Behandlung von Mastitis mit Licht

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5766222A (en) * 1997-07-07 1998-06-16 Petit; Michael G. Nipple illuminator for photodynamic therapy
US20050197681A1 (en) * 2004-02-06 2005-09-08 Lumiphase Inc. Method and device for the treatment of mammalian tissues
DE102005047517A1 (de) * 2004-10-03 2006-06-14 Stefan Bernhard Vorrichtung zur Prävention und Behandlung von Mastitis mit Licht

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8651112B2 (en) 1998-11-30 2014-02-18 David McDaniel Process for treatment of psoriasis
US9192780B2 (en) 1998-11-30 2015-11-24 L'oreal Low intensity light therapy for treatment of retinal, macular, and visual pathway disorders
US9227082B2 (en) 1998-11-30 2016-01-05 L'oreal Method and apparatus for acne treatment using low intensity light therapy
US9814906B2 (en) 1998-11-30 2017-11-14 L'oreal Method and apparatus for skin treatment
US8651111B2 (en) 2003-04-10 2014-02-18 David H. McDaniel Photomodulation methods and devices for regulating cell proliferation and gene expression
WO2021151167A1 (fr) * 2020-01-31 2021-08-05 Cosmoaesthetics Pty Ltd Appareil pouvant être porté sur soi pour le traitement d'une mastite

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