Irradiation device

Abstract

An irradiation device for insertion into an orifice of the body for providing photodynamic therapy or diagnosis comprises: a housing adapted to be fully inserted and secured in the orifice, the housing enclosing an LED lamp system and a power source for powering the LED lamp system wherein the device is independently operational while located within the orifice.

What is claimed is: 
     
         1 . A method of photodynamic therapy of cervical cancer, lesions and conditions comprising
 a) inserting into a patient's vagina and placing onto a treatment area on the patient's cervix an irradiation device, the device comprising a housing adapted to be fully inserted and secured in the vagina, the housing enclosing a LED lamp system which comprises at least one LED and a power source for powering the LED lamp system, wherein the housing comprises a treatment surface which has a size and shape adapted for complementary fit with the treatment area, with the LED lamp system being arranged to, when the device is in operation, emit light from the treatment surface such that the treatment area is illuminated by said light; and   b) activating the device to put it into operation.   
     
     
         2 . The method as claimed in  claim 1  wherein the housing of said device further comprises a flexible outer portion which can, when the device is inserted, adjust its shape to form a secure fit with the vaginal walls. 
     
     
         3 . The method as claimed in  claim 2  wherein the flexible outer portion forms a continuous surface which tapers outwards towards a rear of the device and is frustoconical in shape. 
     
     
         4 . The method as claimed in  claim 2  wherein the flexible outer portion is formed of a resilient material. 
     
     
         5 . The method as claimed in  claim 4  wherein the resilient material is silicone. 
     
     
         6 . The method as claimed in  claim 1  wherein the treatment surface is formed by a surface of a portion of a housing material, wherein said housing material comprises a portion around the LED lamp system and the treatment surface which is transparent to the light emitted from the LED lamp system. 
     
     
         7 . The method as claimed in  claim 1  wherein the LED lamp system is arranged to provide, when the device is in operation, light at a fluence rate of 1-50 mW/cm 2 . 
     
     
         8 . The method as claimed in  claim 7  wherein the LED lamp system is arranged to provide, when the device is in operation, light at a fluence rate of 1-10 mW/cm 2 . 
     
     
         9 . The method as claimed in  claim 1  wherein the LED lamp system emits, when the device is in operation, light having wavelengths in the range of 300-800 nm. 
     
     
         10 . The method as claimed in  claim 1  wherein the LED lamp system comprises a control circuit for regulating the light provided by the at least one LED and wherein the control circuit comprises a receiver for connection to a remote terminal and/or a feedback system and/or one or more performance indicator lights for informing the patient whether the device has operated correctly. 
     
     
         11 . The method as claimed in  claim 1  wherein the device further comprises a lens system arranged to provide homogenous illumination over the treatment area and wherein the treatment surface comprises said lens system. 
     
     
         12 . The method as claimed in  claim 1  wherein said device further comprises a drug carrying area for carrying a composition comprising a photosensitizer or precursor of a photosensitizer, the drug carrying area being provided on the housing. 
     
     
         13 . The method as claimed in  claim 12  wherein said drug carrying area is the treatment surface. 
     
     
         14 . The method as claimed in  claim 12  wherein the composition comprises a 5-ALA ester or a pharmaceutically acceptable salt thereof. 
     
     
         15 . The method as claimed in  claim 14  wherein the composition comprises 5-ALA hexyl ester or a pharmaceutically acceptable salt thereof. 
     
     
         16 . The method as claimed in  claim 12  wherein said composition is applied to the drug carrying area prior to the device being inserted into the patient's vagina. 
     
     
         17 . The method as claimed in  claim 12  wherein the composition is a cream, ointment, gel or paste. 
     
     
         18 . The method as claimed in  claim 1  wherein the device is activated prior to being inserted into the patient's vagina and wherein the control circuit comprises a timer such that the LED lamp system begins to emit light at a pre-determined time interval after activation. 
     
     
         19 . The method as claimed in  claim 18  wherein the control circuit is arranged to switch off illumination after a pre-determined time has elapsed or after a pre-determined dosage has been reached. 
     
     
         20 . The method as claimed in  claim 19  wherein the control circuit is arranged to switch off illumination after a pre-determined dosage has been reached. 
     
     
         21 . The method as claimed in  claim 20  wherein the pre-determined dosage is 10 to 200 J/cm 2 . 
     
     
         22 . The method as claimed in  claim 19  wherein a feature of the control circuit is one or more performance indicator lights for informing the patient whether the device has operated correctly. 
     
     
         23 . The method as claimed in  claim 1  being a method of photodynamic therapy of cervical cancer, lesions and conditions wherein the cancer, lesions or conditions are caused by an HPV infection. 
     
     
         24 . The method as claimed in  claim 1  being a method of photodynamic therapy of cervical lesions or conditions. 
     
     
         25 . The method as claimed in  claim 24  being a method of photodynamic therapy of precancerous cervical lesions or conditions. 
     
     
         26 . The method as claimed in  claim 25  wherein the precancerous cervical lesions or conditions are caused by an HPV infection. 
     
     
         27 . The method as claimed in  claim 1  wherein said method is a method of photodynamic therapy of precancerous cervical lesions and conditions comprising
 a) activating the irradiation device to put it into operation, the device comprising a housing adapted to be fully inserted and secured in the vagina, the housing enclosing a LED lamp system which comprises at least one LED and a power source for powering the LED lamp system, wherein the housing comprises a treatment surface which has a size and shape adapted for complementary fit with a treatment area on a patient's cervix, with the LED lamp system being arranged to, when the device is in operation, emit light from the treatment surface such that the treatment area is illuminated by said light and wherein the treatment surface carries a composition comprising a 5-ALA ester or a pharmaceutically acceptable salt thereof; and 
 b) inserting the device into a patient's vagina and placing it onto the treament area on the patient's cervix; 
 wherein the device further comprises a control circuit which comprises a timer such that the LED lamp system begins to emit light at a pre-determined time interval after activation, said light having a fluence rate of 1-50 mW/cm 2  and wavelengths in the range of 600-690 nm and wherein the control circuit is arranged to switch off illumination after a pre-determined dosage has been reached, said pre-determined dosage being 10 to 20. 
 
     
     
         28 . The method as claimed in  claim 27  wherein the precancerous cervical lesions or conditions are caused by an HPV infection. 
     
     
         29 . The method as claimed in  claim 27  wherein the composition comprises 5-ALA hexyl ester or a pharmaceutically acceptable salt thereof. 
     
     
         30 . The method as claimed in  claim 29  wherein the composition is a cream, ointment, gel or paste.