Device for photodynamic treatment

Abstract

A catheter device for use in the photodynamic treatment of a body cavity or hollow organ of the body, such as the bladder, the device being used in the photodynamic treatment of abnormalities, disorders or diseases of the internal surfaces of said body cavity or hollow organ.

1 - 25 . (canceled) 
     
     
         26 . A catheter device for use in the photodynamic treatment of a body cavity or hollow organ of the body, the catheter device comprising:
 a distal end portion having a longitudinal axis and being for insertion into the body cavity or hollow organ, the distal end portion including:
 (a) an expansion and positioning balloon for expanding within the body cavity or hollow organ and thereby distending an outer wall of the body cavity or hollow organ; 
 (b) a light source located on the distal end portion so as to be within the body cavity or hollow organ when the catheter device is in use; wherein the light source comprises a plurality of light emitting elements arranged to:
 (i) project light forward in a distal direction along the direction of the longitudinal axis from a first region of the distal end, 
 (ii) project light outwardly of the longitudinal axis from a second region of the distal end, the second region being at least partly within the expansion and positioning balloon; and 
 (iii) project light around a point of entry of the catheter device into the body cavity or hollow organ from a third region of the distal end, the third region being closer to the point of entry of the catheter device into the body cavity or hollow organ than the second region; 
 
 and 
 (c) the distal end portion further including a second balloon for retaining the distal end within the body cavity or hollow organ, the second balloon being spaced apart from the expansion and positioning balloon and centred on a location closer to a proximal end of the catheter device than a centre of the expansion and positioning balloon. 
   
     
     
         27 . The catheter device as claimed in  claim 26 , wherein the body cavity or hollow organ of the body is the bladder. 
     
     
         28 . The catheter device as claimed in  claim 26 , wherein the light source is powered by a battery or a low voltage power source that is, in use, outside of the body. 
     
     
         29 . The catheter device as claimed in  claim 26 , wherein light emitting diodes (LEDs) are used as some or all of the light emitting elements. 
     
     
         30 . The catheter device as claimed in  claim 26 , wherein the first region is outside of the expansion and positioning balloon the third region is outside the expansion and positioning balloon and the second region is at least partly inside, or fully inside the expansion and positioning balloon. 
     
     
         31 . The catheter device as claimed in  claim 26 , wherein the plurality of light emitting elements includes at least one light emitting element at each of the first region, the second region and the third region, with the light emitting elements located at each region providing the light that is projected from that region. 
     
     
         32 . The catheter device as claimed in  claim 31 , wherein the light emitting elements are arranged in an array having multiple parts including some or all of a first, distal part located at the first region for projecting light forward in the distal direction, a second, central part located at the second region for projecting light outwardly from the longitudinal axis of the distal end of the catheter device, and a third, proximal part located at the third region for projecting light around the point of entry of the catheter device into the body cavity or hollow organ. 
     
     
         33 . The catheter device as claimed in  claim 32 , wherein the first part of the array is at the tip of the distal end of the catheter device, and includes a light emitting element at the tip facing in the distal direction, the second part of the array includes a plurality of light emitting elements spaced around and along the longitudinal axis of the distal end, and the third part of the array includes a plurality of light emitting elements spaced around and along the longitudinal axis of the distal end. 
     
     
         34 . The catheter device as claimed in  claim 33 , wherein the second part of the array comprises a flexible printed circuit board holding the light emitting elements, the flexible printed circuit board being wrapped in a cylindrical fashion in order to form a generally cylindrical shape holding the light emitting elements of the central part. 
     
     
         35 . The catheter device as claimed  claim 26 , wherein the second balloon is for expansion at the point of entry of the catheter device into the body cavity or hollow organ in order to prevent flow of fluid through a tubular body structure through which the catheter device is inserted and in order to secure the distal end of the catheter device in place within the body cavity or hollow organ. 
     
     
         36 . The catheter device as claimed  claim 26 , wherein the third region of the distal end is partially or fully within the second balloon, thereby ensuring that when the catheter device is in use the third region will be located at a known position relative to the point of entry of the catheter device into the body cavity or hollow organ. 
     
     
         37 . The catheter device as claimed in  claim 26 , wherein at least one of the expansion and positioning balloon or the second balloon has a balloon skin comprising a light attenuating medium, such that the attenuation of light passing through the balloon skin varies depending on the level of inflation of the balloon in order to permit regulation of a light dose based on the level of inflation of the balloon. 
     
     
         38 . The catheter device as claimed in  claim 26 , wherein the expansion and positioning balloon is a sheath along and around a part of the distal end when it is in its unexpanded form. 
     
     
         39 . The catheter device as claimed in  claim 26 , wherein the distal end of the catheter device is provided with at least one fluid inlet/outlet within one or more of the balloons, such that the one or balloons can be expanded by injecting a fluid into the balloon via the catheter device. 
     
     
         40 . The catheter device as claimed in  claim 26 , wherein the distal end comprises a fluid inlet and a fluid outlet for communication with the inside of the hollow organ or body cavity. 
     
     
         41 . The catheter device as claimed in  claim 26 , comprising an elongate catheter body extending from the distal end to a proximal end of the catheter device, wherein the elongate catheter body includes lumens for transport of fluid to and from the various outlets. 
     
     
         42 . The catheter device as claimed in  claim 41 , wherein the elongate catheter body includes one or more lumen for passage of electrical wires. 
     
     
         43 . The catheter device as claimed in  claim 41 , wherein the catheter body includes lumens for passage of fluid and wires embedded in walls of the catheter body. 
     
     
         44 . The catheter device as claimed in  claim 26 , wherein the proximal end of the catheter body is coupled to one or more external elements including a power source, one or more fluid reservoirs for inflation of the balloons(s) and/or for instilling fluid into the body orifice or hollow organ, a receptacle for receiving fluids flushed from the body orifice or hollow organ, and/or a controller. 
     
     
         45 . The catheter device as claimed in  claim 26 , wherein a pressure activated device is provided at the proximal end of the catheter body in order to provide an indication and/or a release of pressure in the event that the pressure within the expansion and positioning balloon and/or within the second balloon exceeds a threshold level. 
     
     
         46 . The catheter device as claimed in  claim 26 , including as an external element a controller the controller including a control circuit for controlling the light source and for providing indications relating to operation of the device, wherein the catheter device includes one or more sensors for measuring a parameter relating to the performance of the device. 
     
     
         47 . The catheter device as claimed in  claim 26 , wherein the plurality of light emitting elements are able to produce irradiation with wavelengths of light in the range of 300-800 nm. 
     
     
         48 . A kit comprising the catheter device of  claim 26  and a photosensitiser or precursor thereof. 
     
     
         49 . A method of photodynamic therapy of a body cavity or hollow organ, the method comprising: administration of a composition comprising 5-ALA, a derivative of 5-ALA or a pharmaceutically acceptable salt thereof to a patient in need of such a photodynamic therapy, inserting the device according to  claim 26  into the body cavity or hollow organ, expanding the body cavity or hollow organ using the expansion and positioning balloon, and irradiating an internal surface of the body cavity or hollow organ with light from the light source.