8. The Umbrella Kit for Photodynamic Therapy and Fluorescent Diagnostics

The Umbrella kit for photodynamic therapy and fluorescent diagnostics is intended for visual diagnostics and treatment by a method of photodynamic therapy of colonies of pathological and oncological cells.

The kit is used independently or together with other therapeutic or surgical laser devices, laser spectral analyzers and other diagnostic instruments in structure of the cabinets of photodynamic therapy in clinics, hospitals and research medical institutions.

The kit assumes work with different types of photosensitizers, first of all, with highly effective and low-toxic drugs such as Photoditazine and Radachlorin.

Design and Function

The Umbrella kit is made on the basis of the increased brightness LED matrix and the specialized CCD video camera with a specially designed light filter providing authentic registration of fluorescence. The kit assumes use of the video image reproduction standard means that are permitted for medical practice.

The Umbrella kit includes the radiating matrix and video camera hardened on holders that can direct the matrix radiation and the video camera observation field to the same area, for example, to a segment of skin surface. The radiating matrix and video camera are connected to a separate power supply unit by means of cables. The power supply unit is intended also for giving of a signal to the video monitor.

The matrix contains group of the light-emitting diodes (more than one thousand pieces) mounted by dense packing on the shaped round surface allowing to focus (in certain limits) the total radiation of set of diodes of the matrix. The matrix is equipped with cooling fans. The video camera is made on the basis of the standard KRS-900 device. In the optical channel of this device there is a filtration of visible part of spectrum, except the fluorescence range, for example, 670 – 680 nm.

The matrix is used for irradiation of pathology area previously sensitized by the PDT drug. Thus the radiation wavelength of LED matrix should coincide with absorption band of the drug. LED irradiation is needed for necrosis development, thus in exposure area there is an accompanying fluorescence of the drug absorbed in a tissue.

Observation of an irradiated surface segment by means of the video camera allows to register a fluorescence area in the form of visually brighter pattern, having compensated the matrix background irradiation. The zone of fluorescence corresponds to the pathology area with the increased absorption of a photosensitizer. The observation procedure of fluorescence of pathology area is diagnostic one. It can precede, accompany therapeutic irradiation or be carried out independently. In the latter case, the matrix radiation intensity (radiation power density and radiation energy density) can be reduced regarding therapeutic values.

Due to possibility of multiple repetition of procedure when using the Photoditazine and Radachlorin photosensitizers (the feature of these drugs which is favorably distinguishing them from other photosensitizers) it is possible to trace process of diagnostics and therapy in dynamics.

Specifications

• Continuous-wave radiation mode of LED matrix.
• Radiation wavelength of LED matrix: 650 – 670 nm.
• Radiation power density of LED matrix in the focal plane: 30 – 60 mW/cm2.
• Area of radiation spot in the focal plane: 40 cm2.
• Focal distance: 20 – 40 cm.
• Overall dimensions of LED matrix: no more than 300 x 300 mm.
• Setting time of operating mode: no more than 5 min.
• Continuous work time: to 6 hours.
• Supply voltage: 220 V ± 10 %.
• Line frequency: 50 Hz.
• Power consumption: no more than 250 VA.
• Weight of the kit: no more than 12 kg.
• Mean time between failures: not less than 1500 hours.
• Mean lifetime: 5 years.

According to laser radiation hazard the kit belongs to Class 2 in accordance with State Standard of R50723-94. The room intended for placement of the kit has to meet the "Sanitary Codes and Rules for the Design and Operation of Lasers" requirements No. 5804-91.

According to shock-hazard protection technique of the patient and service personnel the kit meets requirements of State Standard of 50267.0 for medical equipment of Class II with shock-hazard protection rate by BF type.

Depending on potential risk of use the kit belongs to Class 2b in accordance with State Standard of R51609.

Disinfection of external surfaces of the kit case is carried out in accordance with Branch Standard of 42-21-2 by the 3-percent hydrogen peroxide solution in accordance with State Standard of 177 with addition of the 0.5-percent detergent in accordance with State Standard of 25644.

Delivery Completeness

The Umbrella kit for photodynamic therapy and fluorescent diagnostics is delivered in the following complete set:

• Power supply unit: 1 pc.
• The KRS-900 video camera: 1 pc.
• LED matrix: 1 pc.
• Power cord: 1 pc.
• Technical datasheet: 1 pc.
• The kit storage and transportation bag: 1 pc.
• Holder: 2 pcs.
• Safety goggles: 1 pc.

The video monitor isn't included into the delivery completeness; if necessary it is delivered to the customer for extra pay.

The simplified kit version which doesn't include the KRS-900 video camera is produced and delivered to order.

Completing by holders is made separately, by agreement with the customer.