Illumination – Light fiber – rod – or pipe – Laser
Reexamination Certificate
2001-04-27
2003-04-01
O'Shea, Sandra (Department: 2875)
Illumination
Light fiber, rod, or pipe
Laser
C362S259000, C362S276000, C606S011000
Reexamination Certificate
active
06540391
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates to an apparatus and method for detecting changes in a target site in response to interaction with a target beam of light, and more particularly to an apparatus and method for detecting real time changes in a target site in response to interaction with a target beam of coherent light.
2. Description of Related Art
Pathologies of the Eye: There are several pathologies of the eye that cause some form of visual impairment up to and including blindness. Pathologies currently treated with lasers include glaucoma and retinal disorders. Glaucoma disorders treatable with laser include open angle glaucoma, angle closure glaucoma and neovascular-refractory glaucoma. Retinal disorders treatable with laser include diabetic retinopathy, macular edema, central serous retinopathy and age-related macular degeneration (AMD), etc. Diabetic retinopathy represents the major cause of severe vision loss (SVL) for people up to 65 years of age, while AMD represents the major cause of SVL in people between 65 and 80 years of age. More than 32,000 Americans are blinded from diabetic retinopathy alone, with an estimated 300,000 diabetics at risk of becoming blind. The incidence of AMD in the USA is currently estimated at 2 million new cases per year, of which 1.8 million are with the “dry” form and 200,000 are with the “wet” form, also defined as choroidal neovascularization (CNV). CNV causes subretinal hemorrhage, exudates and fibrosis any of that can lead to SVL and legal blindness. A widely used form of laser treatment for retinal disorders is called laser photocoagulation (P.C.).
Current Modalities Of Laser P.C.: Laser P.C. has become the standard treatment for a number of retinal disorders such as diabetic retinopathy, macular edema, central serous retinopathy, retinal vein occlusion and CNV.
Laser P.C. is a photo-thermal process, in which heat is produced by the absorption of laser energy by targeted tissues, for the purpose of inducing a thermal “therapeutic damage”, which causes biological reactions and ultimately, the beneficial effects. Conventional retinal P.C. relies on some visible “blanching” of the retina as the treatment endpoint and can be defined as Ophthalmoscopically Visible Endpoint Photocoagulation or OVEP. Since the retina is substantially transparent to most wavelengths used in laser P.C., its “blanching” is not caused directly by the laser. Visible “blanching” is the sign that the normal transparency of the retina has been thermally damaged by the conduction of heat generated underneath, at super-threshold level, in laser absorbing chromophores (i.e. melanin) contained in the retinal pigment epithelium (RPE) and in choroidal melanocytes.
The endpoint of visible retinal “blanching” is a practical way to assess the laser treatment, but it also constitutes a disadvantageous and unnecessary retinal damage, which in turn results in a number of undesirable adverse complications including some vision loss, decreased contrast sensitivity and reduced visual fields in a substantial number of patients.
A discussion of the thermal damage resulting in the eye from laser P.C. treatment will now be presented to better illustrate the current OVEP methods, the effects, and the possible ways for limiting or avoiding the current drawbacks.
Retina “blanching” is the result of the spread by conduction of a thermal elevation created around laser absorbing chromophores underneath the retina. The thermal elevation can be controlled by laser: (i) irradiance (power density), (ii) exposure time and (iii) wavelength. High thermal elevations are normally created with current OVEP clinical protocols that are aimed to produce visible endpoints ranging from intense retinal whitening (full thickness retinal burn) to barely visible retinal changes. Although the mechanisms underpinning the efficacy of laser P.C. are still poorly understood, laser P.C. has been proven therapeutically effective and constitutes the standard-of-care in preventing SVL in various ocular disorders. However, because of the drawback of iatrogenic visual impairment due to thermal damage to the neurosensory retina, conventional OVEP laser treatment is presently considered and administered only late in the course of the disease, when has become “clinically significant” and the benefit-to-risk ratio justifies the associated negative effects.
Recent clinical studies have suggested that patients with certain types of diabetes, “dry” AMD and “wet” AMD could benefit from a much earlier treatment. As an example, Laser P.C. is now experimentally administered to patients diagnosed with “dry” AMD presenting with high-risk drusen, as a prophylactic treatment to prevent or delay the progression toward the “wet” form and the consequent SVL. Obviously, more aggressive therapeutic approaches with earlier treatments would easily gain acceptance and be adopted by the ophthalmic community if new user friendly and less damaging laser devices could be available to allow the easy administration of minimally invasive treatment protocols, which would become the new standard-of-care.
New hypotheses on the mechanism of action of laser P.C. postulate that full thickness retinal damage may not be needed to obtain beneficial effects and that any ophthalmoscopically visible retina “blanching” is only a convenient treatment end-point, redundant for the therapeutic effectiveness.
Current laser devices and treatment protocols do not allow to selectively address laser absorbing structures only (primarily melanin containing cells, such as RPE cells and choroidal melanocytes) and to confine the thermal elevation to avoid unnecessary thermal injury to the neurosensory retina. Thus, there is a need for a new laser device and treatment protocols, which can allow more selective targeting and confinement of the laser thermal effects, to avoid or minimize the thermal damage to the overlying neurosensory retina. The present invention provides the solution to this problem by providing a method and apparatus that allows the physician to perform treatments with the minimal therapeutic damage (MTD) confined around the RPE cells and without appreciable damage to the neurosensory retina. This can be defined as Non Ophthalmoscopically Visible Endpoint Photocoagulation or NOVEP treatment, to differentiate from the conventional OVEP treatment.
Preliminary studies on animals with a near IR 810 nm MicroPulse diode laser beam demonstrated the ability to consistently create therapeutic lesions confined around the RPE cells (as studied by light microscopy) without causing apparent damage to the overlying retina. The laser impacts were not visible by slit lamp bio-microscopy at the time of laser delivery.
Recent clinical studies have reported that sub-clinical (invisible) laser lesions created with a NOVEP treatment with the 810 nm MicroPulse diode laser are therapeutically as effective as the conventional OVEP treatment in resolving a variety of retinal disorders. This suggests that the damages to the neurosensory retina created with conventional OVEP treatment are indeed redundant and should be avoided. Unfortunately, the absence of a visible endpoint during the laser treatment renders difficult the choice of the proper irradiation dosage for each individual patient, leaves the physician with no tangible sign of achieved proper threshold for a MTD and creates a potential problem in case of retreatment. Thus there is a need for a device and a method that allow the real-time detection of the achieved sub-clinical (invisible) MTD during the treatment, able to control and terminate the laser emission at a given pre-settable MTD threshold. Furthermore, since from initial clinical studies it was reported that some lesions did not become apparent to slit lamp examination nor to Fluorescein Angiography even after several months, there is also a need for a device that can allow the recording of all successfully placed MTD applications and of their location in the ocular fundus.
Conventional OVEP treatment has proven to be effec
Dorin Giorgio
Lanzetta Paolo
Davis Paul
Heller Ehrman White & McAuliffe
Iridex Corporation
O'Shea Sandra
Sawhney Hargobind S.
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