WO2011130620A2 - Procédé et dispositif pour le traitement amélioré d'un ulcère - Google Patents

Procédé et dispositif pour le traitement amélioré d'un ulcère Download PDF

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Publication number
WO2011130620A2
WO2011130620A2 PCT/US2011/032673 US2011032673W WO2011130620A2 WO 2011130620 A2 WO2011130620 A2 WO 2011130620A2 US 2011032673 W US2011032673 W US 2011032673W WO 2011130620 A2 WO2011130620 A2 WO 2011130620A2
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WO
WIPO (PCT)
Prior art keywords
ulcer
wound
wounds
radiation
treatment device
Prior art date
Application number
PCT/US2011/032673
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English (en)
Other versions
WO2011130620A3 (fr
Inventor
Haralabos Elias
Wolfgang Neuberger
Original Assignee
Ceramoptec Industries, Inc.
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Ceramoptec Industries, Inc. filed Critical Ceramoptec Industries, Inc.
Publication of WO2011130620A2 publication Critical patent/WO2011130620A2/fr
Publication of WO2011130620A3 publication Critical patent/WO2011130620A3/fr

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Classifications

    • 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
    • A61N5/0616—Skin treatment other than tanning
    • 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
    • A61N5/0624—Apparatus adapted for a specific treatment for eliminating microbes, germs, bacteria on or in the body
    • 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
    • A61N2005/0635—Radiation therapy using light characterised by the body area to be irradiated
    • A61N2005/0643—Applicators, probes irradiating specific body areas in close proximity
    • A61N2005/0644—Handheld applicators

Definitions

  • the present invention relates to wound healing treatments, and in particular, to the treatment of ulcers by using local energy-emitting devices and conveying means.
  • Ulcer means a break in the layer of cells forming a surface. They can occur in many different areas of the body. In each different area, there are different factors that cause ulcers to form.
  • a leg ulcer for example is an area of damaged skin below the knee on the leg or foot that takes longer than six weeks to heal. The skin breaks down allowing air and bacteria to get into the underlying tissue. Leg ulcers appear as shallow holes or craters in which the tissue underneath is exposed. They can vary in size, color and depth. Leg ulcers can often be a long-term and recurring condition. Around 80-85% of all leg ulcers are venous leg ulcers, which develop due to poor blood circulation in leg veins.
  • leg ulcers can include arterial leg ulcers, which result from poor circulation in the arteries, and diabetic leg ulcers, which can occur because of diabetes.
  • Venous leg ulcers can be painful and can cause aching, itching and swelling in the affected leg. They become more common with age. It is estimated that one in every 50 people over the age of 80 is affected by venous leg ulcers. They are also more common in those who are obese or immobile.
  • Other ulcers may be associated with metabolic disorders such as diabetes, radiation or chemically treated cancer patients, or burn victims. For example, it has been shown that a lack of insulin inhibits the healing process in diabetics by decreasing wound capillaries, fibroblasts, polymorphonuclear leukocytes, and collagen at the wound site.
  • platelets demonstrate an increase in aggregation, which inhibits their action. Platelets are a source of platelet-derived growth factors (PDGF) which enhance healing; therefore any lack or malfunction of the platelets and subsequently of PDGF would have an adverse effect on healing.
  • PDGF platelet-derived growth factors
  • Wounds can become a major complication in cancer patients if microbes invade the wound site because chemotherapy suppresses the immune system. Almost all chemotherapy agents currently available kill cancer cells by affecting DNA synthesis.
  • cyclophosphamide is an alkylating agent that is used in the treatment of chronic leukemia. Alkylating agents kill cancer cells by directly attacking DNA. However, in the process of attacking cancer cells, the alkylating agents also affect healthy cells and organs, including white blood cells and platelets thereby suppressing the patient's immune system.
  • diabetics and patients with other metabolic disorders have an increased susceptibility to infection due to immune system abnormalities.
  • Angiopathy which leads to hypoxia, inhibits white blood cell (WBC) killing of bacteria by reducing the formation of superoxide radicals and impairs the delivery of antibiotics, antibodies, and granulocytes to the affected site.
  • WBC white blood cell
  • bandages, topical antibiotics, and mechanical scraping have been used as a first line of defense to treat chronic wounds.
  • a conventional treatment for venous leg ulcers involves cleaning and dressing the wound and applying pressure through compression bandages.
  • the surface of the wound is typically cleansed and/or sterilized to enhance the body's natural healing processes.
  • they can take a long time to heal and can recur even after they've fully healed. They can also become infected or develop complications. Additionally, these methods may be inadequate when natural healing mechanisms are affected by complicating factors such as chemotherapy which suppresses the immune system or diabetes which inhibits the production of collagen and/or fibroblasts at the wound site.
  • LSR Ablative laser skin resurfacing
  • Non-ablative laser skin resurfacing methods eliminate the complications commonly associated with ablative laser skin resurfacing by inciting a healing response in the dermis without damaging the epidermal barrier.
  • the risk of infection and scarring is typically eliminated and erythema is greatly reduced when treating facial rhytides because the epidermal hairier remains intact.
  • the epidermis may be damaged prior to laser therapy, therefore, the current non-ablative skin resurfacing methods do not provide a method to prevent infection in wound therapy which is essential in cases where complicating factors are present.
  • non-ablative skin resurfacing methods have found a need and benefit from employing a cooling mechanism to protect the epidermis. Excess cooling can lead to fiber damage and a high radiant exposure is required for effective treatment.
  • Laser energy is reported to have beneficial effects on wound healing (see for example Nemeth A. J. (1993), “Lasers and wound healing " , Dermatology clinics 1 1 (4):783-) by stimulating the immune system, increasing various cytokines and leukocyte population, arresting bacteria] growth, increasing the amount of total collagen and skin circulation and by accelerating the regeneration processes.
  • the absorption spectra of water illustrates a peak in the vicinity of 980 nm indicating that 980 nm light is well absorbed by water.
  • the absorption spectra exhibits a valley in the 1064 nm range indicating that only moderate absorption can be achieved by lasers employing 1064 nm light.
  • 980 nm radiation is preferred over 1064 nm for medical procedures involving soft tissue because greater absorption leads to higher precision, lower penetration results which is especially advantageous in the treatment of chronic wounds.
  • poorly absorbed wavelengths such as 1 064 nm are transmitted through the tissue and penetrate deep into the dermis producing unwanted results for treating chronic wounds.
  • wavelengths such as 10 ⁇ (C0 2 ), 3 ⁇ (Erbium YAG) or 2 ⁇ (Ho-Yag), which have even higher absorption coefficients than 980 nm, are counterproductive for wound treatment.
  • the upper layer can very easily vaporize or burn before the deeper layers is sufficiently heated because the laser radiation does not penetrate to the deeper layers.
  • the 980 nm laser is preferred to selectively injure the lower papillary/upper reticular dermis to activate the synthesis of collagen and to eradicate bacteria within the dermis to accelerate and enhance the healing process.
  • Ultraviolet radiation Another type of treatment for ulcer wounds has been using Ultraviolet radiation.
  • US Patents US4686986 by Fenyo et. al, US7409954 by Dobkine et. al and US6283986 by Johnson teach different methods that apply light therapies in the Ultraviolet range for treating wounds and infections.
  • Ultraviolet radiation is well known for its bactericidal effect and is therefore good for preventing infections. It is not however as effective for stimulation of biological processes for promoting the healing of lesions as other wavelengths in the near infrared portion of the light spectrum.
  • ultraviolet radiation presents several risks. It is known to be carcinogenic and can cause damage to the skin, particularly sunburn and blistering.
  • Combination treatments have also been used on infections, trophic ulcers and non-healing wounds, to try to reduce inflammatory processes and activate the regenerative processes.
  • a combined treatment has been published in Lasers Surg Med. 2009 Aug; 41 (6):433-41 by Minatel et. al.
  • Authors apply combined 660 and 890 nm LED phototherapy to promote healing of diabetic ulcers that failed to respond lo other forms of treatment.
  • Neuberger et. al present in US Patent 6,527,764, a system for laser treatment that couples surgical or activating laser power with a biomodulating power to enhance proper tissue healing and regeneration after treatment. This treatment is achieved using an optical fiber system delivering laser power from two separate laser sources.
  • One source provides laser energy at a power level and density suitable for the surgical or activation action desired.
  • the second source produces laser power at a wavelength suitable for producing biomodulating effects in the treated tissue.
  • Combined treatments are complex and require physician to be highly trained and familiar with different types of energy emitting technologies and their effect on biological tissue. Moreover it is costly, as it requires equipment able to emit and convey different types of radiation energies.
  • Lubart describes a method and device for inducing or promoting growth and proliferation of skin cells or tissue or for controlling bacterial skin infection.
  • the skin cells are irradiated with a low-intensity broad spectrum light at a wavelength of between about 340 to 3,000 ran. Applying such a large a range of wavelengths simultaneously is not beneficial.
  • the spectrum proposed in this patent includes wavelengths mentioned earlier to be ineffective or harmful.
  • a device and method is needed to accelerate wound healing that improves on the state of the art by effectively increasing wound capillaries, fibroblasts, and collagen in the wound site, while simultaneously reducing procedure time and eliminating the risk of infection and other collateral effects.
  • the present invention addresses these needs.
  • a method and device for treating ulcer based on the photobiostimulatio.il effect to reduce inflammation and enhance microvascular activity accelerating the wound healing process.
  • a diode laser source emits 1470 +60 nm laser energy at about 15 Watts, which, is conveyed through an optical fiber and applied onto wound with about a 7 mm spot with a laser pulse preferably set to about 60 msec.
  • An enclosure cap at emission tip confining irradiated area results in enhanced personnel safety.
  • a standalone handheld laser can be used without the need of a fiber/handpiece.
  • a timer or sensing system determines end of radiation.
  • a special technique is used with a point to point laser appliance, irradiating an area of about 1 -2 cm out beyond the edges of the ulcers.
  • a hyaluronic acid gel is generally applied.
  • Optimum treatment can involve multiple irradiations spaced over days/weeks.
  • FIG. 1 depicts a preferred embodiment of present invention describing treatment device's main components.
  • FIG. 2 shows absorption properties of the 1470 nm wavelength in water and in blood.
  • the present invention discloses a device and method which treats ulcerous wounds such as foot and leg ulcers by periodically applying laser energy of a specific wavelength on affected areas and at determined parameters according to characteristics of treated ulcer.
  • optical medical treatment device comprises at least one radiation source; at least one optical waveguide; and a handpiece coupled to said waveguide.
  • Said optical waveguide has a proximal end and a distal end; and it is optically coupled to said radiation source at its proximal end. and transmits radiation to a wound site at its distal end.
  • Said radiation source is capable of producing radiation energy at a preselected wavelength preferably between about 1470 + 60 nm; at a preselected power level preferably in the range of about 10-20 Watts and a preselected power density.
  • Said handpiece is capable of focusing laser energy to said wound site with a spot size within a range of about 1 to 20 mm in diameter.
  • inventions further comprise an enclosure cap for confining irradiated area.
  • time of exposure is determined using added features, a timer system to signal end of treatment and/or a sensing system to signal end of treatment according to changes in target tissue properties in area of said ulcer wounds.
  • laser device 100 comprises diode laser source 102, such as a gallium arsenide semiconductor capable of emitting up to 15 Watts, fiber optic 104 as conveying means, and application handpiece 106 with diameter chosen according to size of ulcer.
  • handpiece 106 comprises an opaque closure cap to seal around the wound borders. This achieves enclosure of emitted radiation within wound area. Thus, healthy skin is protected from radiation. Additionally, patients and medical staff are safe from, stray radiation reaching their eyes.
  • Device irradiates enclosed area until treatment is finished.
  • a preset timer system activates an alarm to indicate end of treatment.
  • a sensing system adequately placed on wound area determines end of treatment. Sensing system is based on parameters that indicate a change in tissue properties such as water content, or light absorption/reflection values.
  • a portable integrated handheld laser system directly irradiates the wound without the need of a fiber or handpiece.
  • Such handheld laser contains a LED source or an OLED source capable of emitting a predetermined wavelength and power to achieve a desired power density. Power density is set by physician according to spot size and/or wound characteristics.
  • Preferred wavelength is 1470 + 60 nm.
  • Fig. 1 shows absorption properties of this wavelength in water and blood.
  • 3470 nm has an absorption coefficient in water of over 20 times greater than 980nm, so electromagnetic energy is highly absorbed in blood, due to the high content of water in blood.
  • the 1470 nm laser is preferred to selectively injure the lower papillary/upper reticular dermis to activate the synthesis of collagen and to eradicate bacteria within the dermis to accelerate and enhance the healing process.
  • radiation energy is applied into the ulcer wound starting at the outermost edge: and then travelling inwards in circular or spiral like motions.
  • radiation energy is applied to the ulcer wound in a point-to-point style; applying about 1 -2 cm outside the edges of said ulcer wound.
  • radiation energy is applied until a termination point based on a preset timer or sensing system endpoint.
  • Present laser device is capable of eradicating bacteria within the dermis to significantly reduce the risk of infection. Eradication of bacteria in the dermis is especially advantageous for treating wounds particularly in situations where the immune system is suppressed.
  • Present invention further provides methods of treating ulcer wounds in which said ulcer wounds are photobiostimulated to accelerate healing by applying a local energy source to said wounds.
  • said local energy source employs laser energy at a preselected wavelength in the range of about 1470 + 60 urn onto the wounds.
  • a method of treating ulcer wounds comprises the steps of preparing said ulcer WOund for treatment; selecting a wavelength, a power level and a power density; transmitting pulsed radiation energy through a waveguide and/or handpiece onto said wound in a non-contact mode; applying a hyaluronic acid jell to said ulcer wound, either before during or after radiation; and repeating the prior steps periodically until size of ulcer wound shrinks or disappears.
  • ulcers were categorized as chronic (>6 weeks) and 13 as acute ( ⁇ 6 weeks).
  • Laser parameters were set to 60 msec pulse duration applied through a 7 mm spot, for an average fluency (energy) of 50-70 J/cm 2 on the wounds.
  • the laser treatment was well tolerated by patients.
  • Results evaluation was based on the progress and the level of the ulcer healing (closure), the time/sessions required for the healing, and existence of side effects.
  • Results showed that, 77.7% of the venous ulcers, 62.5% of the neurotrophic ulcers, 87.5% of the arterial and 100% of the traumatic were completely closed.
  • the average healing period healing was 5.02 weeks (3-32 weeks).
  • 65.2% of the chronic ulcers and 100% of the acute ulcers were completely healed.
  • the 9 ulcers that were not completely healed by the end of the study were significantly reduced in size.
  • Tabie 2 Summary analysis and healing progress of the 9 non-healed ulcers
  • aiming beam can be set to a diameter set within a range between 1 and 20 mm.
  • power density can be selected within a range of 1 0- 100 J/cnr.
  • the pulse duration of the pulsed radiation energy transmitted through a waveguide and/or handpiece onto the ulcer wound being treated, in a non- contact mode is selected within a range of about 10- 100 msec.
  • laser therapy can be preceded by mechanically scraping (debriding) the surface of the wound.
  • Debriding removes necrotic tissue and debris from the wound surface to prepare the wound site for laser therapy.
  • a transparent wound cover with a bacteriostatic or bactericidal agent can then be applied to the wound site to prevent microbial invasion and to allow moisture to escape from the wound surface.
  • the photothermal energy selectively stimulates the lower papillary/upper reticular dermis which leads to fibroblast activation and synthesis of new collagen and extracellular matrix material.
  • additional methods may be employed after the laser treatment to accelerate angiogenesis, and to increase the breakdown of dead tissue and fibrin. In most clinical cases, experienced physicians may prefer to set their own treatment values considering other clinical criteria.

Abstract

La présente invention concerne un procédé et un dispositif pour traiter des ulcères sur la base de l'effet de photobiostimulation pour réduire l'inflammation, et augmenter l'activité microvasculaire de manière à accélérer le processus de cicatrisation des plaies. Dans un mode de réalisation préféré, une source laser à diode émet de l'énergie laser à 1470 + 60 nm d'environ 15 watts, qui est transmise par une fibre optique et appliquée sur une plaie avec un spot d'environ 7 mm avec une impulsion laser de préférence réglée à environ 60 ms. Un capuchon d'enceinte à pointe d'émission confinant la zone irradiée conduit à une sécurité du personnel améliorée. Un laser portatif autonome peut être utilisé sans nécessiter une fibre/pièce à main. De plus, un minuteur ou système de détection détermine la fin du traitement de rayonnement. Un traitement efficace, rapide, aisé et sûr d'ulcères veineux, artériels et neurotrophiques, chroniques et aigus est obtenu. Dans un autre mode de réalisation, une technique spéciale est utilisée avec un appareil laser point à point, irradiant une zone d'environ 1 à 2 cm au-delà des bords des ulcères. Après chaque traitement, un gel d'acide hyaluronique est généralement appliqué. Un traitement optimal peut mettre en œuvre des irradiations multiples espacées sur des jours/semaines.
PCT/US2011/032673 2010-04-16 2011-04-15 Procédé et dispositif pour le traitement amélioré d'un ulcère WO2011130620A2 (fr)

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US32481610P 2010-04-16 2010-04-16
US61/324,816 2010-04-16

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WO2011130620A3 WO2011130620A3 (fr) 2012-04-19

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040162549A1 (en) * 2002-11-12 2004-08-19 Palomar Medical Technologies, Inc. Method and apparatus for performing optical dermatology
US20060004306A1 (en) * 2004-04-09 2006-01-05 Palomar Medical Technologies, Inc. Methods and products for producing lattices of EMR-treated islets in tissues, and uses therefor
US20070213792A1 (en) * 2002-10-07 2007-09-13 Palomar Medical Technologies, Inc. Treatment Of Tissue Volume With Radiant Energy
US20080077204A1 (en) * 2003-10-08 2008-03-27 Nomir Medical Technologies, Inc. Optical biofilm therapeutic treatment

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20070213792A1 (en) * 2002-10-07 2007-09-13 Palomar Medical Technologies, Inc. Treatment Of Tissue Volume With Radiant Energy
US20040162549A1 (en) * 2002-11-12 2004-08-19 Palomar Medical Technologies, Inc. Method and apparatus for performing optical dermatology
US20080077204A1 (en) * 2003-10-08 2008-03-27 Nomir Medical Technologies, Inc. Optical biofilm therapeutic treatment
US20060004306A1 (en) * 2004-04-09 2006-01-05 Palomar Medical Technologies, Inc. Methods and products for producing lattices of EMR-treated islets in tissues, and uses therefor

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