Abstract:
A photoreactive agent and a drug therapy device including a support member configured to pass through a urethra having proximal and distal ends and a longitudinal internal lumen. A light generator carried by the support member, potted within the lumen, and positioned within the urethra to deliver light to the prostate. The light generator generates a light band with a peak at a preselected wavelength. A power source external to the support member powers the light generator. The positioning element locates the support member within the urethra. A transparent/translucent, integral window is positioned proximate to the prostate and allows light to pass through. The window extends 360 degrees radially from the support member. The light generator has at least LEDs or LOs having a dimension of approximately 0.3 mm×0.3 mm×0.1 mm (length×width×thickness).

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application is a Continuation-In-Part application of a co-pending U.S. patent application Ser. No. 11/834,572, filed on Aug. 6, 2007 which is a Continuation-In-Part application of U.S. Pat. No. 7,252,677 that issued Aug. 7, 2007 from U.S. patent application Ser. No. 10/799,357, filed on Mar. 12, 2004, which is based on a U.S. Provisional Application Ser. No. 60/455,069, filed on Mar. 14, 2003. All of these applications are herein incorporated by reference in their entirety. 
         [0002]    This application is a Continuation-In-Part application of a co-pending U.S. patent application Ser. No. 12/161,323, which entered U.S. on Nov. 19, 2008, which in turn is the National Stage of International Application PCT/US2007/01324, filed Jan. 18, 2007, and published as WO 2007/084608 on Jul. 26, 2007. The International Application claims priority to Chinese Application No. 200620088987.8, filed Jan. 18, 2006. All of the above referenced applications are herein incorporated by reference in their entirety. 
     
    
     FIELD OF THE INVENTION 
       [0003]    The present invention relates generally to a prostate treatment system for treating prostatic tissue in combination with a photoactive agent, and more specifically a transurethral device in combination with a light-activated drug for use in treating benign prostatic hyperplasia (BPH). 
       BACKGROUND 
       [0004]    Photodynamic therapy (PDT) is a process whereby light of a specific wavelength or waveband is directed to tissues undergoing treatment or investigation, which have been rendered photosensitive through the administration of a photoreactive or photosensitizing agent. Thus, in this therapy, a photoreactive agent having a characteristic light absorption waveband is first administered to a patient, typically by intravenous injection, oral administration, or by local delivery to the treatment site. Abnormal tissue in the body is known to selectively absorb certain photoreactive agents to a much greater extent than normal tissue. Once the abnormal tissue has absorbed or linked with the photoreactive agent, the abnormal tissue can then be treated by administering light of an appropriate wavelength or waveband corresponding to the absorption wavelength or waveband of the photoreactive agent. Such treatment can result in the necrosis of the abnormal tissue. PDT has proven to be very effective in destroying abnormal tissue such as cancer cells. 
         [0005]    Benign prostatic hyperplasia (BPH) and prostate cancer are common conditions in the older male population. For people with BPH, the enlarged prostate can compress the urethra causing obstruction of the urine pathway, which results in difficulty urinating. The enlarged prostate can also cause urethral stones, inflammation, infection and in some instances, kidney failure. 
         [0006]    Major treatment methods for BPH include surgical treatment such as a prostatectomy or transurethral resection of the prostate. These treatments require the patient to be hospitalized, which can be a financial burden to the patient. Additionally, surgical procedures can result in significant side effects such as bleeding, infection, residual urethral obstruction or stricture, retrograde ejaculation, and/or incontinence or impotence. Patients who are too old or who have weak cardiovascular functions are not good candidates for receiving these treatment methods. PDT, also known as light-activated drug therapy, in comparison to surgical alternatives, is minimally invasive, less costly, and has a lower risk of complications. 
         [0007]    One type of light delivery system used for light-activated drug therapy comprises the delivery of light from a light source, such as a laser, to the targeted cells using an optical fiber delivery system with special light-diffusing tips on the fibers. This type of light delivery system may further include optical fiber cylindrical diffusers, spherical diffusers, micro-lensing systems, an over-the-wire cylindrical diffusing multi-optical fiber catheter, and a light-diffusing optical fiber guide wire. This light delivery system generally employs a remotely located high-powered laser, or solid-state laser diode array, coupled to optical fibers for delivery of the light to the targeted cells. 
         [0008]    The light source for the light delivery system used for light-activated drug therapy may also be light emitting diodes (LEDs) or solid-state laser diodes (LDs). LEDs or LDs may be arrayed in an elongated device to form a “light bar” for the light delivery system. The LEDs or LDs may be either wire bonded or electrically coupled utilizing a “flip chip” technique that is used in arranging other types of semiconductor chips on a conductive substrate. Various arrangements and configurations of LEDs or LDs are described in U.S. Pat. Nos. 5,445,608; 6,958,498; 6,784,460; and 6,445,011, which are incorporated herein by reference. 
         [0009]    One of the challenges in design and production of light bars relates to size. The largest diameter of the light bar is defined by human anatomy and the smallest diameter is defined by the size of the light emitters that emit light of a desired wavelength or waveband at a sufficient energy level, and the fragility of the bar as its thickness is reduced, which increases the risk of breaking in the patient. 
         [0010]    Presently, there exists a need for an apparatus for light-activated drug therapy for effectively treating prostate via the urethra that is cost effective, less invasive than other treatments, and has less risk of complications. Accordingly, there is a need for smaller LEDs or LDs and other light sources that are safe for use in a urethra tract introduced via a catheter-like device. 
       SUMMARY 
       [0011]    Thus, examples of the invention include a transurethral light-activate drug therapy system for the treatment of prostate conditions in a male animal having an enlarged prostate. The device includes a photoreactive agent of mono-L-aspartyl chlorine e6 and a transurethral light activate drug therapy device. The device includes a flexible elongated support member configured to pass through a urethra of the male animal, the elongated support member having a proximal end and a distal end and at least one longitudinal internal lumen through a majority of a length of the elongated support member. A light delivery device having a light generator carried by a distal region of the support member and potted within the lumen, the light generator and a light emitting region are configured to be positioned within the urethra to deliver light to the prostate. The light generator is configured to generate a light band with a peak at a preselected wavelength of about 664 nm radially at 360 degrees. Also, a power source external to the support member is in flexible electrical communication with the light generator and a positioning element carried by the support member. 
         [0012]    The positioning element is configured to locate the support member within the urethra while a majority of the portion of the support member is inserted into the urethra of the male animal and does not permit light from the light generator to pass through. A transparent or translucent, integral window along a portion of the length of the support member is proximate to the prostate when the distal end of the support member is positioned in the bladder of the male animal and allows light from the light generator to pass through the window, and the window extends 360 degrees radially from the support member. The length of the light generator is at least as long as a majority of the length of the window, a majority of the length of the light generator is fixed in place within the window, and when the support member is completely removed from the urethra, the light generator is completely removed from the urethra. The light generator has at least one or more of a light emitting diodes (LEDs), and solid-state laser diode (LO) having a dimension of approximately 0.3 mm×0.3 mm×0.1 mm (length×width×thickness). 
         [0013]    The window, in some examples, has embedded light scattering elements. Further, the each of LEDs or LOs is potted in a potting material that is electrically insulating and substantially optically transparent to light emitted from the light generator. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0014]    The following drawings are intended as an aid to an understanding of the invention to present examples of the invention, but do not limit the scope of the invention as described and claimed herein. In the drawings, identical reference numbers identify similar elements or acts. The sizes and relative positions of elements in the drawings are not necessarily drawn to scale. For example, the shapes of various elements and angles are not drawn to scale, and some of these elements are arbitrarily enlarged and positioned to improve drawing legibility. Further, the particular shapes of the elements as drawn, are not intended to convey any information regarding the actual shape of the particular elements, and have been solely selected for ease of recognition in the drawings. 
           [0015]      FIG. 1  schematically illustrates a first embodiment of a light-generating apparatus suitable for intravascular use in accord with the present invention; 
           [0016]      FIG. 2  is a longitudinal cross-sectional view of the light-generating apparatus of  FIG. 1 ; 
           [0017]      FIGS. 3A and 3B  are exemplary radial cross-sectional views of two different embodiments of the light-diffusing portion of the light-generating apparatus of  FIG. 1 ; 
           [0018]      FIG. 4A  schematically illustrates a second embodiment of a light-generating apparatus suitable for intravascular use in accord with the present invention; 
           [0019]      FIG. 4B  is a longitudinal cross-section view of the light-generating apparatus of  FIG. 2 ; 
           [0020]      FIG. 5  schematically illustrates yet another embodiment of a light-generating apparatus suitable for intravascular use in accord with the present invention; 
           [0021]      FIG. 6  is an elevational side view of a prostate treatment system having a transurethral treatment device according to one embodiment of the invention; 
           [0022]      FIG. 7  is a cross-sectional view taken along line  2 - 2  of  FIG. 6  illustrating one embodiment of lumens in the transurethral treatment device; 
           [0023]      FIG. 8  schematically illustrates a multicolor light array for use in the light-generating apparatus of  FIGS. 5-7 ; 
           [0024]      FIGS. 9A and 9B  schematically illustrate configurations of light arrays including strain relief features for enhanced flexibility for use in a light-generating apparatus in accord with the present invention; 
           [0025]      FIG. 9C  is cross-sectional view of a light-generating apparatus in accord with the present invention, showing one preferred configuration of how the light emitting array is positioned relative to the guidewire used to position the light-generating apparatus; 
           [0026]      FIG. 9D  schematically illustrates a portion of a light-generating apparatus in accord with the present invention, showing how in another preferred configuration, the light emitting array is positioned relative to the guidewire used to position the light-generating apparatus; 
           [0027]      FIG. 10  is side view of a transurethral treatment device positioned in the urethra tract of a patient according to an embodiment of the invention; 
           [0028]      FIG. 11  is a cross-sectional view of a transurethral treatment device in accordance with another embodiment of the invention; 
           [0029]      FIG. 12A  schematically illustrates a modified guidewire for use in the light-generating transurethral apparatus of  FIGS. 10 and 11 ; 
           [0030]      FIGS. 12B-12D  are cross-sectional views of the guidewire of  FIG. 12A , showing details of how the light emitting elements are integrated into the guidewire; 
           [0031]      FIGS. 13A and 13B  schematically illustrate a hollow guidewire including a light source array disposed at its distal end; 
           [0032]      FIG. 13C  schematically illustrates a connection jack that can be used to electrically couple the array in the hollow guidewire of  FIGS. 13A and 13B  to a power source; 
           [0033]      FIG. 13D  is a cross-sectional view of the connection jack taken along section line A-A of  FIG. 13C ; 
           [0034]      FIG. 13E  is a cross-sectional view of the connection jack taken along section line B-B of  FIG. 13C ; 
           [0035]      FIG. 13F  is a cross-sectional view of the guidewire of  FIGS. 13A and 13B  taken along section line C-C of  FIG. 13B ; 
           [0036]      FIG. 13G  is a side view of a first exemplary array for the guidewire of  FIGS. 13A and 13B ; 
           [0037]      FIG. 13H  is a plan view of the first exemplary array for the guidewire of  FIGS. 13A and 13B ; 
           [0038]      FIG. 13I  is a plan view of a second exemplary array for the guidewire of  FIGS. 13A and 13B ; 
           [0039]      FIG. 13J  is a plan view of a third exemplary array for the guidewire of  FIGS. 13A and 13B ; 
           [0040]      FIG. 13K  is a side view of a fourth exemplary array for the guidewire of  FIGS. 13A and 13B ; 
           [0041]      FIG. 13L  is a plan view of the fourth exemplary array for the guidewire of  FIGS. 13A and 13B ; 
           [0042]      FIG. 13M  is a plan view of a large array from which the fourth exemplary array can be removed for facilitating manufacturing of the fourth exemplary array; 
           [0043]      FIG. 13N  schematically illustrates yet another hollow guidewire including a light source array disposed at its distal end; 
           [0044]      FIG. 13O  is a cross-sectional view of the hollow guidewire of  FIG. 13N  taken along section line D-D of  FIG. 13N ; 
           [0045]      FIG. 13P  is a cross-sectional view of the hollow guidewire of  FIG. 13N  taken along section line E-E of  FIG. 13N ; 
           [0046]      FIG. 14A  schematically illustrates still another embodiment of a light-generating apparatus, which includes a plurality of inflatable balloons, as the apparatus is being positioned within a urethra; 
           [0047]      FIG. 14B  is a cross-sectional view of the light-generating apparatus of  FIG. 14A ; 
           [0048]      FIG. 14C  schematically illustrates an alternative configuration of a light-generating apparatus including a plurality of inflatable balloons, as the apparatus is being positioned within a urethra; 
           [0049]      FIG. 14D  is a cross-sectional view of the light-generating apparatus of  FIG. 14C ; 
           [0050]      FIG. 15  schematically illustrates a plurality of balloons included with a light-generating apparatus in accord with the present invention; 
           [0051]      FIG. 16A  is a cross-sectional view of one example of a light emitting catheter disposed in a central lumen of an introducer catheter; 
           [0052]      FIG. 16B  is a side view of a light source array for use in the light emitting catheter of  FIG. 16A ; 
           [0053]      FIG. 17  is a cross-sectional view of a transurethral treatment device in accordance with yet another embodiment of the invention; 
           [0054]      FIG. 18  is a cross-sectional view of a transurethral treatment device in accordance with still another embodiment of the invention; and 
           [0055]      FIG. 19  is a cross-sectional view of a transurethral treatment device in accordance with another embodiment of the invention. 
       
    
    
     DETAILED DESCRIPTION 
       [0056]    Exemplary embodiments are illustrated in referenced Figures of the drawings. It is intended that the embodiments and Figures disclosed herein are to be considered illustrative rather than restrictive. No limitation on the scope of the technology and of the claims that follow is to be imputed to the examples shown in the drawings and discussed herein. 
         [0057]    In the following description, certain specific details are set forth in order to provide a thorough understanding of various embodiments of the invention. However, one skilled in the relevant art will recognize that the invention may be practiced without one or more of these specific details, or with other methods, components, materials, etc. In other instances, well-known structures associated with light sources, catheters and/or treatment devices have not been shown or described in detail to avoid unnecessarily obscuring descriptions of the embodiments of the invention. 
         [0058]    Unless otherwise defined, it should be understood that each technical and scientific term used herein and in the claims that follow is intended to be interpreted in a manner consistent with the meaning of that term as it would be understood by one of skill in the art to which this invention belongs. The drawings and disclosure of all patents and publications referred to herein are hereby specifically incorporated herein by reference. In the event that more than one definition is provided herein, the explicitly defined definition controls. 
         [0059]    Referring to  FIG. 1 , a light-generating apparatus  1 , having a distal end  6  and a proximal end  8 , is embodied in a catheter having an elongate, flexible body  4  formed from a suitable biocompatible material, such as a polymer or metal. Catheter body  4  includes at least one lumen  18 . While lumen  18  is shown as centrally disposed within catheter body  4 , it should be understood that lumen  18  can be disposed in other positions, and that other lumens, such as lumens for inflating a balloon or delivering a fluid (neither separately shown) can also be included and disposed at locations other than along a central axis of catheter body  4 . Lumen  18  has a diameter sufficient to accommodate a guidewire and extends between distal end  6  and proximal end  8  of the catheter, passing through each portion of light-generating apparatus  1 .  FIG. 1  is not drawn to scale, and a majority of light-generating apparatus  1  shown in  FIG. 1  relates to elements disposed near distal end  6 . It should be understood that light-generating apparatus  1  is preferably of sufficient length to be positioned so that distal end  6  is disposed at a treatment site within a patient&#39;s body, while proximal end  8  is disposed outside of the patient&#39;s body, so that a physician or surgeon can manipulate light-generating apparatus  1  with the proximal end. 
         [0060]    A light source array  10  includes a plurality of light emitting devices, which are preferably LEDs disposed on conductive traces electrically connected to lead  11 . Lead  11  extends proximally through lumen  18  and is coupled to an external power supply and control device  3 . While lead  11  is shown as a single line, it should be understood that lead  11  includes at least two separate conductors, enabling a complete circuit to be formed that supplies current to the light emitting devices from the external power supply. As an alternative to LEDs, other sources of light may instead be used, including but not limited to: organic LEDs, super luminescent diodes, laser diodes, and light emitting polymers. In a preferred embodiment, each LED of light source array  10  is encapsulated in a polymer layer  23 . Preferably, collection optics  12  are similarly encapsulated in polymer layer  23 . Light source array  10  is preferably coupled to collection optics  12 , although it should be understood that collection optics  12 , while preferred, are not required. When present, collection optics  12  are coupled to either a single optical fiber  14 , or an optical fiber bundle (not separately shown). Distal to optical fiber  14  is a light-diffusing tip  16 , which can be implemented using glass or plastic. Light emitted from light source array  10  passes through collection optics  12 , which focus the light toward optical fiber  14 . Light conducted along optical fiber  14  enters diffusing tip  16  at distal end  6  and is scattered uniformly. Preferably, diffusing tip  16  includes a radio-opaque marker  17  to facilitate fluoroscopic placement of distal end  6 . 
         [0061]      FIG. 2  illustrates a longitudinal cross-section view of light-generating apparatus  1 . Collection optics  12  (e.g., a lens) are bonded to light source array  10  and optical fiber  14  by polymer layers  23 , and the polymer layer is preferably an epoxy that is optically transparent to the wavelengths of light required to activate the photoreactive agent that is being used. Individual LEDs  10   a  and leads  10   b  (each coupling to lead  11 ) can be clearly seen. 
         [0062]      FIG. 3A  is a radial cross-sectional view of diffusing tip  16 , which includes one diffusing portion  36  and lumen  18 .  FIG. 3B  is a radial cross-sectional view of an alternative diffusing tip  16   a , which includes a plurality of diffusing portions  36  encapsulated in a polymer  33 , and lumen  18 . Polymer  33  preferably comprises an epoxy, and such an epoxy will likely be optically transparent to the wavelengths of light required to activate the photoreactive agent being utilized; however, because the light will be transmitted by diffusion portions  36 , polymer  33  is not required to be optically transparent to these wavelengths. In some applications, it may be desirable to prevent light of any wavelength that can activate the photoreactive agent from exiting a light-generating apparatus other than from its distal end, and polymers do not transmit such wavelengths can be used to block such light. 
         [0063]    Turning now to  FIG. 4A , another embodiment of a light generating catheter is schematically illustrated. A light-generating apparatus  5  is similarly based a catheter having body  4 , including lumen  18 , and includes distal end  6  and proximal end  8 . As discussed above, while only a single lumen configured to accommodate a guidewire is shown, it should be understood that light-generating apparatus  5  can be configured to include additional lumens as well (such as those used for balloon inflation/deflation). Note that  FIGS. 4A and 4B  are not drawn to scale; with distal end  6  being emphasized over proximal end  8 . 
         [0064]    Light-generating apparatus  5  includes a light source array  40  comprising a plurality of LEDs  40   a  (seen in phantom view) that are electrically coupled to lead  11  via leads  40   c . As discussed above, light source array  40  is preferably encapsulated in a light-transmissive polymer  23 , or at least, in an epoxy that transmits the wavelengths of light required to activate the photoreactive agent introduced into the target tissue. Positioned immediately behind LEDs  40   a  (i.e., proximal of LEDs  40   a ) is a highly-reflective disk  40   b . Any light emitted from LEDs  40   a  in a direction toward proximal end  8  is reflected back by reflective disk  40   b  towards distal end  6 . Additionally, a reflective coating  43  (such as aluminum or another reflective material), is applied to the outer surface of body  4  adjacent to light source array  40 . Any light from LEDs  40   a  directed to the sides (i.e., towards body  4 ) is redirected by reflective coating  43  towards distal end  6 . Reflective disk  40   b  and reflective coating  43  thus cooperatively maximize the intensity of light delivered through distal end  6 . 
         [0065]    Light source array  40  is coupled to a focusing lens  42 , which in turn, is coupled to an optical fiber bundle  44 . Preferably, optical fiber bundle  44  tapers toward distal end  6 , as shown in  FIGS. 4A and 4B ; however, it should be understood that this tapered shape is not required. Optical fiber bundle  44  is coupled to a light-diffusing tip  46 . An expandable member  47  (such as an inflatable balloon) is included for centering light-generating apparatus  5  within a urethra or blood vessel and for occluding blood flow past distal end  6  that could reduce the amount of light delivered to the targeted tissue. The expandable member is preferably secured to distal end  6  so as to encompass light-diffusing tip  46 . Expandable member  47  may be formed from a suitable biocompatible material, such as, polyurethane, polyethylene, fluorinated ethylene propylene (PEP), polytetrafluoroethylene (PIPE), or polyethylene terephthalate (PET). 
         [0066]    It should be understood that while light source array  40  has been described as including a plurality of LEDs  40   a  disposed on conductive traces electrically connected to lead  11 , light source array  40  can alternatively use other sources of light. As noted above, possible light sources include, but are not limited to, organic LEDs, super luminescent diodes, laser diodes, and light emitting polymers. While not shown in  FIGS. 4A and 4B , it should be understood that light-generating apparatus  5  can beneficially incorporate a radio-opaque marker, as described above in conjunction with light-generating apparatus  1  (in regard to radio-opaque marker  17  in  FIGS. 1A and 1B ). 
         [0067]      FIG. 5  schematically illustrates yet another embodiment of a light-generating catheter in accord with the present invention. This embodiment employs a linear light source array configured so that a more elongate treatment area can be illuminated. While the first and second embodiments described above use an elongate light diffusing element to illuminate an elongate treatment area, because the light diffusing elements are directing light, not generating light, increasing the length of the diffusing elements merely distributes the light over a greater area. If diffused over too great an area, insufficient illumination will be provided to each portion of the treatment site. The embodiment shown in  FIG. 5  includes a linear light source array that enables an elongate treatment area to be illuminated with a greater amount of light than can be achieved using the embodiments shown in  FIGS. 1-4B . 
         [0068]    Referring to  FIG. 5 , light-generating apparatus  50  is illustrated. As with the embodiments described above (i.e., the light-generating apparatus shown in  FIGS. 1 and 4 ), light-generating apparatus  50  is preferably based on a multi-lumen catheter and includes an elongate, flexible body formed from a suitable biocompatible polymer or metal, which includes a distal portion  52  and a proximal portion  54 . A plurality of light emitting devices  53  are disposed on a flexible, conductive substrate  55  encapsulated in a flexible cover  56  (formed of silicone or other flexible and light transmissive material). Light emitting devices  53  and conductive substrate  56  together comprise a light source array. Preferably, light emitting devices  53  are LEDs, although other light emitting devices, such as organic LEDs, super luminescent diodes, laser diodes, or light emitting polymers can be employed. Each a light source array preferably ranges from about 1 cm to about 20 cm in length, with a diameter that ranges from about 0.5 mm to about 5 mm. Flexible cover  56  can be optically transparent or can include embedded light scattering elements (such as titanium dioxide particles) to improve the uniformity of the light emitted from light-generating apparatus  50 . While not specifically shown, it should be understood that proximal portion  54  includes an electrical lead enabling conductive substrate  56  to be coupled to an external power supply and control unit, as described above for the embodiments that have already been discussed. 
         [0069]    The array formed of light emitting devices  53  and conductive substrate  56  is disposed between proximal portion  54  and distal portion  52 , with each end of the array being identifiable by radio-opaque markers  58  (one radio-opaque marker  58  being included on distal portion  52 , and one radio-opaque marker  58  being included on proximal portion  54 ). Radio-opaque markers  58  comprise metallic rings of gold or platinum. Light-generating apparatus  50  includes an expandable member  57  (such as a balloon) preferably configured to encompass the portion of light-generating apparatus  50  disposed between radio-opaque markers  58  (i.e., substantially the entire array of light emitting devices  53  and conductive substrate  56 ). As discussed above, expandable member  57  enables occlusion of blood flow past distal portion  52  and/or centers the light-generating apparatus. Where expandable member is implemented as a fluid filled balloon, the fluid acts as a heat sink to reduce a temperature build-up caused by light emitting devices  53 . This cooling effect can be enhanced if light-generating apparatus  50  is configured to circulate the fluid through the balloon, so that heated fluid is continually (or periodically) replaced with cooler fluid. Preferably, expandable member  57  ranges in size (when expanded) from about 2 mm to 15 mm in diameter. Preferably such expandable members are less than 2 mm in diameter when collapsed, to enable the apparatus to be used in a coronary vessel. Those of ordinary skill will recognize that catheters including an inflation lumen in fluid communication with an inflatable balloon, to enable the balloon to the inflated after the catheter has been inserted into a urethra or blood vessel are well known. While not separately shown, it will therefore be understood that light-generating apparatus  50  (particularly proximal portion  54 ) includes an inflation lumen. When light emitting devices  53  are energized to provide illumination, expandable member  57  can be inflated using a radio-opaque fluid, such as Renocal 76® or normal saline, which assists in visualizing the light-generating portion of light-generating apparatus  50  during computerized tomography (CT) or angiography. The fluid employed for inflating expandable member  57  can be beneficially mixed with light scattering material, such as Intralipid, a commercially available fat emulsion, to further improve dispersion and light uniformity. 
         [0070]    Light-generating apparatus  50  is distinguished from light-generating apparatus  1  and  4  described above in that light-generating apparatus  1  and  4  are each configured to be positioned within a vessel or other passage using a guidewire that extends within lumen  18  substantially throughout the apparatus. In contrast, light-generating apparatus  50  is positioned at a treatment site using a guidewire  51  that does not pass through the portion of light-generating apparatus  50  that includes the light emitting devices. Instead, guidewire  51  is disposed external to light-generating apparatus  50 —at least between proximal portion  54  and distal portion  52 . Thus, the part of guidewire  51  that is proximate to light emitting devices  53  is not encompassed by expandable member  57 . Distal portion  52  includes an orifice  59   a , and an orifice  59   b . Guidewire  51  enters orifice  59   a , and exits distal portion  52  through orifice  59   b . It should be understood that guidewire  51  can be disposed externally to proximal portion  54 , or alternatively, the proximal portion can include an opening at its proximal end through which the guidewire can enter the proximal portion, and an opening disposed proximally of light emitting devices  53 , where the guidewire then exits the proximal portion. 
         [0071]    The length of the linear light source array (i.e., light emitting devices  53  and conductive substrate  56 ) is only limited by the effective length of expandable member  57 . If the linear array is made longer than the expandable member, light emitted from that portion of the linear array will be blocked by blood within the vessel and likely not reach the targeted tissue. As described below in connection with  FIGS. 14A-14D , the use of a plurality of expandable members enables even longer linear light source arrays (i.e., longer than any single expandable member) to be used in this invention. 
         [0072]      FIG. 6  illustrates a prostate treatment system  600 . This uses a light delivery device similar to the ones described above and they can be used as described below. This example includes a power supply  601  and a transurethral treatment device  621  having an elongated support member  602  and a light delivery device  606  positioned along or within the support member  602 . The transurethral treatment device  620  may further includes a balloon  603  or other type of positioning element carried by the elongated support member  602 . The support member  602  can be a catheter having a lumen  604 , or the support member  602  can be a closed body without a lumen. According to an embodiment, the support member  602  has a total length of 400 to 450 mm and has an outer diameter of 3.327 mm, and the balloon  603  at the distal end of the support member  602  has a volume of 610 to 30 ml and is used to position and fix the light delivery device  606  proximate to the treatment site such as the prostate. In another example, the support member  602  has a total length of 400 to 800 mm and has an outer diameter of approximately 5.33 mm (or 16 French), and the balloon  603  at the distal end of the support member  602  has a volume of 610 to 10 ml (cc). 
         [0073]    The light delivery device  606  can have a light generator  606   a  and a light emitting region  606   b . In the embodiment shown in  FIG. 6 , the light generator  606   a  and the light emitting region  606   b  are at approximately the same location of the elongated member, but in other embodiments shown below, the light generator  606   a  may not be coincident with the light emitting region  606   b . As shown below, the light generator  606   a  may be located towards the proximal end of the support member  602 . When the support member  602  is a catheter with a lumen  604 , the light delivery device  606  can move within the lumen to be positioned relative to the treatment site. In other embodiments, the light delivery device  606  can be disposed on the surface of the catheter  602  below the balloon  603  or other type of positioning element. The power for the light generator can be transmitted to the light delivery device  606  via a lead wire  607  coupled to the power source  601 . According to an embodiment of the invention, light could be emitted by a light emitting diode (LED), a laser diode, light-emitting polymer, or a quartz fiber tip optically coupled to another internal source of light energy. 
         [0074]    As illustrated in  FIG. 7 , the support member  602  can include a plurality of lumens therein. For example, the balloon  603  is connected to a fluid inlet  605  via lumen  604 . Gas or liquid can be pumped into inlet  605  and through lumen  604  to inflate balloon  603 . Referring to  FIGS. 6 and 7  together, the transurethral treatment device  621  can optionally have a urine aperture  611  positioned at the distal end of the support member  602  that is connected to a urine collection bag  613  via a urine lumen  612 . The urine aperture  611  can be used to collect the patient&#39;s urine during treatment. 
         [0075]    The transurethral treatment device  621  can also optionally include a temperature measuring system having at least one of a temperature sensor  608  and a temperature monitor  610 . The temperature sensor  608  can be a thermocouple or other sensor as is known in the art. The temperature sensor  608  is disposed on or thermally coupled to a surface of the support member  602  and is electrically connected to the temperature monitor  610  via wires  609  disposed within the support member  602 . The temperature sensor  608  measures a temperature at the treatment site, for example, proximate to the prostate during treatment. A control loop (not shown) may further be connected to the temperature monitor  610  to automatically shut the treatment device off in the event that the temperature at the treatment site exceeds a predetermined value. Alternatively, the temperature monitor  610  may further include a warning device (not shown), such as a visual indicator or audible indicator, to provide an operator with a warning that a predetermined temperature has been reached or is being exceeded during treatment. 
         [0076]      FIGS. 8, 9A, and 9B  are enlarged views of light source arrays that can be used in a light-generating apparatus that can be used in a prostate treatment system. Light source array  80 , shown in  FIG. 8 , includes a plurality of LEDs  86   a  and  86   b  that are coupled to a flexible, conductive substrate  82 . LEDs  86   a  emit light of a first color, having a first wavelength, while LEDs  86   b  emit light of a different color, having a second wavelength. Such a configuration is useful if two different photoreactive agents have been administered, where each different photoreactive agent is activated by light of a different wavelength. Light source array  80  also includes one or more light sensing elements  84 , such as photodiodes or a reference LED, similarly coupled to flexible, conductive substrate  82 . Each light sensing element  84  may be coated with a wavelength-specific coating to provide a specific spectral sensitivity, and different light sensing elements can have different wavelength-specific coatings. While light source array  80  is configured linearly, with LEDs on only one side (as is the array in light-generating apparatus  50   a  of  FIG. 5 ), it will be understood that different color LEDs and light sensing elements can be beneficially included in any of the light source arrays described herein. 
         [0077]    Because the light source arrays of the present invention are intended to be used in flexible catheters inserted into the urethra or other body passages, it is important that the light source arrays be relatively flexible, particularly where a light source array extends axially along some portion of the catheter&#39;s length. Clearly, the longer the light source array, the more flexible it must be. Light source arrays  10  and  40  ( FIGS. 1A / 1 B, and  4 A/ 4 B, respectively) are configured in a radial orientation, and light emitted from the light sources in those arrays is directed to the distal end of the respective catheters (light-generating apparatus  1  and  4 ). Because light source arrays  10  and  40  do not extend axially along a substantial portion of their respective catheters, the relatively flexibility of light source arrays  10  and  40  is less important. However, light source array  80  ( FIG. 8 ), and the light source arrays of light-generating apparatus  50  and  606  ( FIGS. 5 and 6 , respectively), are linearly configured arrays that extend axially along a more significant portion of their respective catheters. A required characteristic of a catheter for insertion into a urethra is that the catheter be sufficiently flexible to be inserted into the urethra and advanced along a somewhat tortuous path. Thus, light source arrays that extend axially along a portion of a catheter can unduly inhibit the flexibility of that catheter.  FIGS. 9A and 9B  schematically illustrate axially extending light source arrays that include strain relief features that enable a more flexible linear array to be achieved. 
         [0078]      FIG. 9A  shows a linear array  88   a  having a plurality of light emitting sources  90  (preferably LEDS, although other types of light sources can be employed, as discussed above) mounted to both a first flexible conductive substrate  92   a , and a second flexible conductive substrate  92   b . Flexible conductive substrate  92   b  includes a plurality of strain relief features  93 . Strain relief features  93  are folds in the flexible conductive substrate that enable a higher degree of flexibility to be achieved. Note that first flexible conductive substrate  92   a  is not specifically required and can be omitted. Further, strain relief features  93  can also be incorporated into first flexible conductive substrate  92   a.    
         [0079]      FIG. 9B  shows a linear array  88   b  having a plurality of light emitting sources  90  mounted on a flexible conductive substrate  92   c . Note that flexible conductive substrate  92   c  has a crenellated configuration. As shown, light emitting sources  90  are disposed in each “notch” of the crenellation. That is, light emitting sources  90  are coupled to both an upper face  93   a  of flexible conductive substrate  92   c , and a lower face  93   b  of flexible conductive substrate  92   c . Thus, when light emitting sources  90  are energized, light is emitted generally outwardly away from both upper surface  93   a  and lower surface  93   b . If desired, light emitting sources  90  can be disposed on only upper surface  93   a  or only on lower surface  93   b  (i.e., light emitting sources can be disposed in every other “notch”), so that light is emitted generally outwardly away from only one of upper surface  93   a  and lower surface  93   b . The crenellated configuration of flexible conductive substrate  92   c  enables a higher degree of flexibility to be achieved, because each crenellation acts as a strain relief feature. 
         [0080]    External bond wires can increase the cross-sectional size of an LED array, and are prone to breakage when stressed.  FIGS. 1A and 1B  illustrate leads  10   b  that are exemplary of such external bond wires.  FIG. 9C  schematically illustrates a flip-chip mounting technique that can be used to eliminate the need for external bond wires on LEDs  94  that are mounted on upper and lower surfaces  93   c  and  93   d  (respectively) of flexible conductive substrate  92   d  to produce a light source array  97 . Any required electrical connections  95  pass through flexible conductive substrate  92   d , as opposed to extending beyond lateral sides of the flexible conductive substrate, which would tend to increase the cross-sectional area of the array. Light source array  97  is shown encapsulated in a polymer layer  23 . A guidewire lumen  98   a  is disposed adjacent to light source array  97 . An expandable balloon  99  can encompass the array and guidewire lumen. Note that either, but not both, polymer layer  23  and expandable balloon  99  can be eliminated (i.e., if the expandable balloon is used, it provides protection to the array, but if not, then the polymer layer protects the array). 
         [0081]      FIG. 9D  shows a linear array  96  including a plurality of light emitting sources (not separately shown) that spirals around a guidewire lumen  98   b . Once again, balloon  99  encompasses the guidewire lumen and the array, although if no balloon is desired, a polymer layer can be used instead, as noted above. For each of the implementations described above, the array of light sources may comprise one or more LEDs, organic LEDs, super luminescent diodes, laser diodes, or light emitting polymers ranging from about 1 cm to about 10 cm in length and having a diameter of from about 1 mm to about 2 mm. 
         [0082]    As illustrated in  FIG. 10 , the treatment device is positioned transurethrally to allow access to the prostate, followed by administration of a photoactive drug, by injection, intravenously, or orally. The transurethral treatment device  621 , and more specifically a portion of the support member  602 , can be directed into the urethra under topical anesthesia. Once the support member is positioned, 4 to 10 ml of saline or air can be pumped into the balloon  603  via the air pumping channel  604  to inflate the balloon  603 . After inflation of the balloon  603 , the support member  602  can be pulled slightly proximally such that the balloon  603  can be fixed at the inner opening of the urethra. Accordingly, the light delivery device  606  can be (by design) positioned at least proximate to or within the prostate. The photoactive drug can then be administered to the patient, and the light generator  606   b  can be activated. 
         [0083]    The support member  602  has a proximal portion and a distal portion relative to a power controller. The distal portion of support member  602  includes the light delivery device  606 . In one embodiment, the light delivery device comprises a plurality of LEDs in electrical communication with the power supply via lead wires  607  as shown in  FIG. 6 . The lead wires may be selected from any suitable conductor that can be accommodated within the dimensions of the support member, for example: a bus bar that electronically couples the LEDs to the controller; flexible wires; a conductive film or ink applied to a substrate, and the like. Additionally or alternatively, the light delivery device may include Bragg reflectors to better control the wavelength of the light that is to be transmitted to the target cells. 
         [0084]    A power controller  601  may be programmed to activate and deactivate LEDs of a light delivery device in a pulsed sequence or a continuous sequence. For example, the LEDs may form two halves of the light array that may be turned on and off independently from each other. Alternatively, the system may be programmed to selectively activate and deactivate (e.g., address) different selected individual or groups of LEDs along the length of the bar. In this manner, a treatment protocol, for example causing the LEDs to be lit in a certain sequence or at a particular power level for a selected period of time, may be programmed into the controller. Therefore, by selectively timing the pulses and/or location of the light, the system delivers light in accordance with a selected program. Alternatively, LEDs can be powered by DC continuously. Examples of addressable light transmission arrays are disclosed in U.S. Pat. No. 6,096,066, herein incorporated in its entirety by reference. Exemplary light transmission arrays which include shielding or distal protection are disclosed in U.S. patent application Ser. No. 10/799,357, now U.S. Pat. No. 7,252,677, and Ser. No. 10/888,572 (now abandoned), herein incorporated in their entirety by reference. 
         [0085]    Without being bound by any theory, applicants believe that by delivering light in pulses, the efficacy of the light-activated drug therapy is improved, given that the treated tissue is allowed to reoxygenate during the cycles when the light is off. Applicants further believe that tissue oxygenation during therapy is improved by using a lower frequency. In one embodiment the operational frequency is 50 Hz-5 kHz, and in one embodiment, is 50-70 Hz. 
         [0086]    According to a further embodiment of the invention, the treatment device may further include a temperature monitoring system for monitoring the temperature at the treatment site. 
         [0087]    In one embodiment, the support member  602  is a Foley catheter and the light delivery device  606  is disposed in the Foley catheter. Alternatively, the treatment device has a light delivery device disposed in a conventional balloon catheter. Foley catheters are available in several sub-types, for example, a Coude catheter has a 45° bend at the tip to allow easier passage through an enlarged prostate. Council tip catheters have a small hole at the tip which allows them to be passed over a wire. Three-way catheters are used primarily after bladder, prostate cancer or prostate surgery to allow an irrigant to pass to the tip of the catheter through a small separate channel into the bladder. This serves to wash away blood and small clots through the primary arm that drains into a collection device. 
         [0088]      FIG. 11  is a cross-sectional view of still another embodiment of a transurethral treatment device  621 . In this embodiment, the light delivery device includes a light generator  606   a  along the support member  602  at a location that is either within or external (shown) to the patient. The light delivery device can further include a light emitting region  606   b  positioned at least proximate to the treatment site and a light transmitting region  606   c  (e.g., fiber optic) between the light generator  606   a  and the light emitting region  606   b . In  FIG. 11 , the support member  602  can be a catheter through which the light delivery device  606  can be moved for positioning, or the support member can be a closed body to which the light delivery device  606  is attached (e.g., fixed at a set position). 
         [0089]      FIGS. 12A-12D  provide details showing how light emitting devices can be integrated into guidewires for even easier insertion into the urethra. Referring to  FIG. 12A , a solid guidewire  120  includes a conductive core  124  and a plurality of compartments  121  formed in the guidewire around the conductive core. Conductive core  124  is configured to be coupled to a source of electrical energy, so that electrical devices coupled to conductive core  124  can be selectively energized by current supplied by the source. Compartments  121  can be formed as divots, holes, or slots in guidewire  120 , using any of a plurality of different processes, including but not limited to, machining, and laser cutting or drilling. Compartments  121  can be varied in size and shape. As illustrated, compartments  121  are arranged linearly, although such a linear configuration is not required. Preferably, each compartment  121  penetrates sufficiently deep into guidewire  120  to enable light emitting devices  122  to be placed into the compartments and be electrically coupled to the conductive core, as indicated in  FIG. 12B . A conductive adhesive  123  can be beneficially employed to secure the light emitting devices into the compartments and provide the electrical connection to the conductive core. Of course, conductive adhesive  123  is not required, and any suitable electrical connections can alternatively be employed. Preferably, LEDs are employed for the light emitting devices, although as discussed above, other types of light sources can be used. If desired, only one compartment  121  can be included, although the inclusion of a plurality of compartments will enable a light source array capable of simultaneously illuminating a larger treatment area to be achieved. 
         [0090]    Once light emitting devices  122  have been inserted into compartments  121  and electrically coupled to conductive core  124 , a second electrical conductor  126 , such as a flexible conductive substrate or a flexible conductive wire, is longitudinally positioned along the exterior of guidewire  120 , and electrically coupled to each light emitting device  122  using suitable electrical connections  128 , such as conductive adhesive  123  as (illustrated in  FIG. 12B ) or wire bonding (as illustrated in  FIG. 12C ). Guidewire  120  (and conductor  126 ) is then coated with an insulating layer  129 , to encapsulate and insulate guidewire  120  (and conductor  126 ). The portion of insulating layer  129  covering light emitting devices  122  must transmit light of the wavelength(s) required to activate the photoreactive agent(s). Other portions of insulating layer  129  can block such light transmission, although it likely will be simpler to employ a homogenous insulating layer that transmits the light. Additives can be included in insulating layer  129  to enhance the distribution of light from the light emitting device, generally as described above. 
         [0091]    With respect to guidewires including integral light sources, it should be noted that a guidewire that can emit light directly simplifies light activated therapy, because clinicians are already well versed in the use of guidewires to facilitate insertion of catheters for procedures such as angioplasty or stent delivery. A guidewire including integral light sources can be used with conventional balloon catheters, to provide a light activated therapy capability to catheters not originally exhibiting that capability. Significantly, when such a guidewire is utilized with a catheter including a central guidewire lumen and a non-compliant angioplasty balloon, inflation of the balloon will center the guidewire in the body lumen, and will hold the guidewire in place during the light therapy (so long as the balloon is inflated). The inflated balloon will exert pressure outwardly on the vessel wall and inwardly on the guidewire. Preferably, the guidewires disclosed herein with integral light sources will be similar in size, shape and handling characteristics as compared to commonly utilized conventional guidewires, such that clinicians can leverage their prior experience with non-light emitting guidewires. It is also possible to use the light emitting guidewires disclosed herein without a balloon catheter. If the vessel being treated has a diameter that is just slightly larger than the guidewire, there will be a very thin layer of blood present between the light emitting elements and the vessel wall. In this case, the light emitting guidewire can be used alone, directing the light through the thin layer of blood to treat the vessel wall. This has the advantage of allowing treatment into extremely small vessels that would otherwise not be accessible with conventional techniques. 
         [0092]    Yet another exemplary embodiment of a guidewire incorporating light sources at a distal end of the guidewire is schematically illustrated in  FIGS. 13A and 13B . A guidewire  200  is based on a nitinol hypotube  202 , which includes a flexible circuit of LEDs (i.e., a light source array  220 , shown in  FIGS. 13B and 13F ) disposed inside a distal end  204  of the hypotube. In at least one exemplary embodiment, the distal end of the nitinol hypotube is laser cut to remove a majority of the tube material proximate to the LED array, yet retain the columnar structure of the tube. In a particularly preferred embodiment, about 75-90% of the portion of the tube surrounding the LED array is eliminated.  FIG. 13B  enables additional details of distal end  204  of tube  202  to be identified. Note that the material removal process (e.g., laser cutting, although it should be recognized that other material removing techniques can be employed) results in the formation of a plurality of openings  206 . As illustrated, the openings are generally quadrilateral in shape, although it should be recognized that the particular shape of the openings is not critical. Furthermore, it should be recognized that the dimensions noted in  FIG. 13B  are intended to be exemplary, rather than limiting. Openings  206  are configured to enable light from the LEDs that are disposed within the hypotube proximate to the openings to pass through the openings. Conductors  208  and  210  extend from array  220  to a proximal end of the guidewire, to enable the array to be selectively energized by an external power source. 
         [0093]    Many conventional guidewires are available having an outer diameter of about 0.035 inches. Initial exemplary working embodiments of guidewires including integral LED light sources have ranged from about 0.0320 inches to about 0.0348 inches in diameter. Fabrication techniques are discussed in greater detail below, but in general, the LED array is potted inside the nitinol hypotube. A heat shrink tube can be applied over the openings overlying the LED array during potting/curing, to be removed afterwards, or simply left in place. 
         [0094]    Nitinol is an excellent material for guidewires, because it exhibits sufficient flexibility and push-ability. It has radio-opaque properties, such that the LED portion will likely be readily identifiable under fluoroscopy, since the LED portion is encompassed by the plurality of openings, and the openings will reduce the radio-opacity of that portion of the guidewire relative to portions of the guidewire that do not include such openings. If necessary, additional markers can be included proximally and distally of the plurality of openings, to enable that portion of the guidewire to be precisely positioned in a body lumen. Another benefit of nitinol is that its thermal conductivity will enable heat generated by the LEDs to be more readily dissipated. Cooler operating temperatures for the LED array will improve wall plug efficiency and enable higher irradiance output. Standard steerable and anti-traumatic guidewire tips can be attached to such nitinol hypotube guidewires, distal of the light source array. 
         [0095]    Note that guidewire  200  is configured such that a standard angioplasty catheter can fit over the entire length of guidewire  200 . Thus, some sort of connector that fits inside the guidewire cross-sectional area is required, to enable the light source array disposed within the distal end of the guidewire to be electrically coupled to a power supply. In an empirical prototype, an “RCA-like” jack with two electrical terminations was fabricated from conductively-plated stainless steel capillary tubes. This connector was mated with a female connector to provide the electrical control for the LED light therapy.  FIG. 13C  schematically illustrates a proximal end of guidewire  200  including such a connector jack. Conductors  208  and  210  extend from the proximal end of guidewire  200  to the light source array (for example, an LED array) disposed at the distal end of guidewire  200 , to enable the light source array to be energized by an external power supply (not separately shown). The connector jack includes tubes  212  and  214 . When the connector jack is fully assembled, tube  214  is disposed inside tube  212 , and a distal end of tube  212  is inserted into the proximal end of guidewire  200 . An insulating spacer  216  separates tube  212  into a proximal portion and a distal portion. A proximal end of conductor  210  is electrically coupled to the distal portion of tube  212 . Conductor  208  passes through the distal portion of tube  212 , and completely through tube  214 . Note that tube  214  passes through insulating spacer  216 , so that conductor  208  can be electrically coupled to the proximal portion of tube  212 . Any void spaces in tubes  212  and  214  are filled with an insulating potting material  218 .  FIG. 13D  is a cross-sectional view of the connector jack taken along section line A-A of  FIG. 13C , and  FIG. 13E  is a cross-sectional view of the connector jack taken along section line B-B of  FIG. 13C . In an exemplary, but not limiting embodiment, tube  212  has an inner diameter of 0.020 inches, and an outer diameter of 0.025 inches, and tube  214  has an inner diameter of 0.012 inches, and an outer diameter of 0.018 inches. 
         [0096]      FIG. 13F  is a cross-sectional view of the distal end of guidewire  200 , taken along section line C-C of  FIG. 13B , enabling a light source array  220  to be observed. As noted above, void space surrounding array  220  can be filled with a potting material  218   a , which is electrically insulating and optically transparent (note the potting material employed in the connector jack of  FIG. 13C  need not be optically transparent). In an exemplary, but not limiting embodiment, nitinol hypotube guidewire  200  has an inner diameter of 0.0270 inches (0.64 mm), and an outer diameter of 0.0325 inches (0.76 mm). Conductors  208  and  210  can be implemented, for example, using wire having an outer diameter of 0.009 inches (0.23 mm), and the light source array has a generally rectangular form factor, having maximum dimensions of 0.021 inches in width and 0.010 inches in height. It should be recognized that such stated dimensions are intended to be exemplary, rather than limiting. 
         [0097]      FIG. 13G  is a cross-sectional view of light source array  220 , which includes a plurality of LEDs  224  (oriented in a linear array) mounted on a flexible non-conductive substrate  222 . While no specific number of LEDs is required, empirical devices including more than 30 LEDs have been fabricated. Significantly, substrate  222  is substantially transparent to the light emitted by LEDs  224 , such that light emitted from the LEDs is able to pass through the substrate. Each LED emits light from each of its six faces (the LEDs being generally cubical). Compared to two sided arrays, a single sided array offers the advantages of lower manufacturing costs, a smaller form factor, and cooler operating temperatures (resulting in a greater light output per LED). Polyimide represents an acceptable substrate material. While some polyimides have a generally yellowish tint, that tint does not substantially interfere with the transmission of red light. Empirical devices show less than a 5% transmission loss due to passage of the light through the substrate, though losses as high as 10% are still acceptable. If blue LEDs are used, higher transmission losses are to be expected, and a thinner substrate, or a different material that is more transparent to blue light, can be employed. Conductive traces  228  and bonding wires  226  enable the LEDs to be coupled to conductors  208  and  210  (not separately shown in  FIG. 13G ). The LEDs, traces, and bonding wires are encapsulated in potting material  218   a , which as noted above, is electrically insulating and substantially optically transparent to the light emitted by the LEDs. It should be noted that the potting material need not achieve the generally rectangular form factor shown. An array including no potting material could be introduced into the distal end of the nitinol hypotube, such that the void space in the guidewire surrounding the array is filled with a potting material, thereby achieving a cylindrical rather than rectangular form factor for the potting material surrounding the array. 
         [0098]      FIG. 13H  is a plan view of array  220 . Note that LEDs  224  are arranged linearly, with conductive traces  228  extending parallel to the linear array of LEDs, one trace on the right side of the LEDs, and another trace on the left side of the LEDs, with bonding wires  226  coupling the LEDs to the traces. While not specifically shown, it should be recognized that the traces are electrically coupled to the conductors  208  and  210 , thereby enabling the array to be energized. In an alternative array  220   a , shown in  FIG. 13I , cutouts are provided in a substrate  222   a  underneath the LEDS, so that the flexible substrate does not interfere with the light emitted from the LED faces parallel to and immediately adjacent to the substrate (thus enabling less optically transparent substrate materials to be employed). In yet another exemplary array  220   b , shown in  FIG. 13J , the flexible substrate does not extend much beyond the conductive traces, such that the LED array is disposed between two parallel rails  234 , each rail comprising a conductive trace deposited on top of a flexible substrate. While such a configuration is initially less structurally robust than configurations in which the supporting substrate is lager, once array  220   b  is encapsulated in a light transmissive potting material, such a configuration will be sufficiently robust. Significantly, array  220   b  is easier to manufacture than the other array designs. Each of the array configurations of  FIGS. 13H, 13I, and 13J  enable the LEDs to be wired in series or in parallel. 
         [0099]      FIG. 13K  is a cross-sectional view of yet another light source array  220   c , which has an even smaller form factor than arrays  220 ,  220   a , and  220   b . Array  220   c  also includes a plurality of LEDs  224  (again oriented in a linear array) mounted on a flexible substrate  222   b , with conductive traces  228   a  and bonding wires  226   a , to enable the LEDs to be coupled to conductors configured so that the array can be energized using an external power supply (not separately shown in  FIG. 13K ). Note that in array  220   c , the width of flexible substrate  222   a  is limited to the width of LEDs  224 , thereby enabling a reduction in the total width to be achieved. The positions of bonding wires  226   a  are changed relative to their orientation in arrays  220 ,  220   a , and  220   b . This change is clearly illustrated in  FIG. 13L , which shows a plan view of array  220   c . Note that traces  228   a  are oriented perpendicular to an axis  230  along which the linear LED array extends. Significantly, the LEDs in array  220   c  can only be wired in series. 
         [0100]      FIG. 13M  schematically illustrates how array  220   c  can be manufactured. A plurality of LEDs  224  and traces  228   b  are deposited onto an extensive substrate  222   c . Bonding wires  226   a  are used to electrically couple the LEDs to the traces. The substrate is cut as indicated by arrows  232 , thereby creating three linear arrays  220   c . It should be recognized that each linear array  220   c  can include more than two LEDs. 
         [0101]      FIG. 13N  is a schematic view of a guidewire  200   a , enabling details of distal end  204  of tube  202   a  to be identified. Guidewire  200   a  is smaller in diameter than guidewire  200 , enabling the narrower linear light source array (i.e., array  220   c ) to be employed. In addition to the plurality of openings  206 , guidewire  200   a  includes an opening  236  disposed distally of openings  206 , encompassing array  220   c . Because the potting material encompassing array  220   a  doesn&#39;t need to extend proximally of the array, the portion of tube  202   a  extending proximally of array  220   c  defines a substantial lumen that can be used to deliver a fluid, such as a drug, to opening  236 . In one exemplary embodiment, natural blood flow in a body lumen will carry the drug downstream toward the vessel wall that would be illuminated by the LEDs in array  220   c . Yet another structure that can be used to deliver such a drug comprises an optional compliant balloon  238  with micro-pores configured to leak the drug into the body lumen once a certain pressure is reached, while the compliant balloon conforms to the body lumen. If such a balloon is used, opening  236  is not required, and the fluid entering the balloon is provided by the hollow tube proximal of the array. 
         [0102]      FIG. 13O  is a cross-sectional view of a distal end of guidewire  200   a , taken along section line D-D of  FIG. 13N , into which array  220   c  has been inserted. Any void space surrounding array  220   c  can be filled with potting material  218   a , which is electrically insulating and optically transparent. In an exemplary, but not limiting embodiment, nitinol hypotube guidewire  200   a  has an inner diameter of 0.0170 inches, and an outer diameter of 0.0204 inches. Significantly, guidewire  200   a  is implemented in this embodiment using silver-coated nitinol, such that the guidewire itself can be used as one of the paired conductors required to energize array  220   a . The silver coating is deposited on the interior surface of the hypotube, forming a reflective interior that enhances light emission from the LED array. It should be noted however, that the conductive coating can also be applied to the external surface of the guidewire. While a silver coating is preferred, other conductive coatings (e.g., gold, copper, and/or other conductive elements or alloys) can be employed. Because the guidewire includes a conductive coating, only a single conductor  234  is required to be disposed within guidewire  200   a . Conductor  234  is implemented using 36 gauge wire (AWG) for conveying a positive signal, while the silver-coated nitinol hypotube conveys a ground signal. As noted above, light source array  220   a  has a generally rectangular form factor, having maximum dimensions of 0.015 inches in width and 0.009 inches in height. Again, it should be recognized that such stated dimensions are intended to be exemplary, rather than limiting. While nitinol represents an exemplary material, it should be recognized that many other materials, such as polymers and other metals (such stainless steel, to mention just one additional example), can be employed to implement a hollow guidewire. 
         [0103]      FIG. 13P  is a cross-sectional view of guidewire  200   a , taken along section line E-E of  FIG. 13N . Note that open lumen  235  surrounding conductor  234  can be used as a fluid delivery lumen. 
         [0104]    With respect to the LEDs employed in the arrays, non-reflector LED semiconductors that emit light out all six sides can be employed. These LED dies can be attached to a polyimide flexible substrate without traces under the LED dies, such that light is projected through the polyimide material. In the visible red region the polyimide can pass over 90% of the light. If a slightly less standard polyester flex circuit is used then the entire visible spectrum down into UV ranges pass well over 95% of the emitted light. 
         [0105]    Groups of LEDs can be connected in series in order to average the forward voltage drop variation of individual dies; as this technique greatly improves manufacturing consistency. If longer lightbars/arrays are required, then such serial grouping can be connected in parallel. For example, in one empirical exemplary embodiment, eight parallel groups of six LEDs connected in series (i.e., 48 LEDs) were used to fabricate a linear array 5 cm in length. 
         [0106]    With respect to embodiments including a plurality of expandable members, such a configuration enables a linear light source array that is longer than any one expandable member to be employed to illuminate a treatment area that is also longer than any one expandable member.  FIGS. 14A, 14B, 14C, and 14D  illustrate apparatus including such a plurality of expandable members.  FIGS. 14A and 14B  show an apparatus employed in connection with an illuminated guidewire, while  FIGS. 14C and 14D  illustrate an apparatus that includes a linear light source array combined with the plurality of expandable members. In each embodiment shown in these FIGURES, a relatively long light source array (i.e., a light source array having a length greater than a length of any expandable member) is disposed between a most proximally positioned expandable member and a most distally positioned expandable member. 
         [0107]      FIG. 14A  schematically illustrates a light-generating apparatus  131  for treating relatively large prostates in a urethra  137 . Light-generating apparatus  131  is based on a multi-lumen catheter  130  in combination with an illuminated guidewire  135  having integral light emitting devices. Multi-lumen catheter  130  is elongate and flexible, and includes a plurality of expandable members  133   a - 133   d . While four such expandable members are shown, alternatively, more or fewer expandable members can be employed, with at least two expandable members being particularly preferred. As discussed above, such expandable members occlude urine flow and center the catheter in the urethra. Multi-lumen catheter  130  and expandable members  133   a - 133   d  preferably are formed from a suitable bio-compatible polymer, including but not limited to: polyurethane, polyethylene, PEP, PTFE, PET, PEBA, PEBAX or nylon. Each expandable member  133   a - 133   d  preferably ranges from about 2 mm to about 15 mm in diameter and from about 1 mm to about 60 mm in length. When inflated, expandable members  133   a - 133   d  are pressurized from about 0.1 atmosphere to about 16 atmospheres. It should be understood that between expandable member  133   a  and expandable member  133   d , multi-lumen catheter  130  is formed of a flexible material that readily transmits light of the wavelengths required to activate the photoreactive agent(s) with which light-generating apparatus  131  will be used. Bio-compatible polymers having the required optical characteristics can be beneficially employed. As discussed above, additives such as diffusion agents can be added to the polymer to enhance the transmission or diffusion of light. Of course, all of multi-lumen catheter  130  can be formed of the same material, rather than just the portions between expandable member  133   a  and expandable member  133   d . Preferably, each expandable member  133   a - 133   d  is similarly constructed of a material that will transmit light having the required wavelength(s). Further, any fluid used to inflate the expandable members should similarly transmit light having the required wavelength(s). 
         [0108]    Referring to the cross-sectional view of  FIG. 14B  (taken along lines section lines A-A of  FIG. 14A ), it will be apparent that multi-lumen catheter  130  includes an inflation lumen  132   a  in fluid communication with expandable member  133   a , a second inflation lumen  132   b  in fluid communication with expandable members  133   b - c , a flushing lumen  134 , and a working lumen  136 . If desired, each expandable member can be placed in fluid communication with an individual inflation lumen. Multi-lumen catheter  130  is configured such that flushing lumen  134  is in fluid communication with at least one port  138  (see  FIG. 14A ) formed through the wall of multi-lumen catheter  130 . As illustrated, a single port  138  is disposed between expandable member  133   a  and expandable member  133   b  and functions as explained below. 
         [0109]    Once multi-lumen catheter  130  is positioned within urethra  137  so that a target area is disposed between expandable member  133   a  and expandable member  133   d , inflation lumen  132   a  is first used to inflate expandable member  133   a . Then, the flushing fluid is introduced into urethra  137  through port  138 . The flushing fluid displaces urine distal to expandable member  133   a . After sufficient flushing fluid has displaced the urine flow, inflation lumen  132   b  is used to inflate expandable members  133   b ,  133   c , thereby trapping the flushing fluid in portions  137   a ,  137   b , and  137   c  of urethra  137 . The flushing fluid readily transmits light of the wavelength(s) used in administering PDT, whereas if urine were disposed in portions  137   a ,  137   b , and  137   c  of urethra  137 , light transmission would be blocked. An alternative configuration would be to provide an inflation lumen for each expandable member, and a flushing port disposed between each expandable member. The expandable members can then be inflated, and each distal region can be flushed, in a sequential fashion. 
         [0110]    A preferred flushing fluid is saline. Other flushing fluids can be used, so long as they are non toxic and readily transmit light of the required wavelength(s). As discussed above, additives can be included in flushing fluids to enhance light transmission and dispersion relative to the target tissue. Working lumen  136  is sized to accommodate light emitting guidewire  135 , which can be fabricated as described above. Multi-lumen catheter  130  can be positioned using a conventional guidewire that does not include light emitting devices. Once multi-lumen catheter  130  is properly positioned and the expandable members are inflated, the conventional guidewire is removed and replaced with a light emitting device, such as an optical fiber coupled to an external source, or a linear array of light emitting devices, such as LEDs coupled to a flexible conductive substrate. While not specifically shown, it will be understood that radio-opaque markers such as those discussed above can be beneficially incorporated into light-generating apparatus  131  to enable expandable members  133   a  and  133   d  to be properly positioned relative to the target tissue. 
         [0111]    Still another embodiment of the present invention is light-generating apparatus  141 , which is shown in  FIG. 14C  disposed in a urethra  147 . Light-generating apparatus  141  is similar to light-generating apparatus  131  describe above, and further includes openings for using an external guide wire, as described above in connection with  FIG. 5 . An additional difference between this embodiment and light-generating apparatus  131  is that where light emitting devices were not incorporated into multi-lumen catheter  130  of light-generating apparatus  131 , a light emitting array  146  is incorporated into the catheter portion of light-generating apparatus  141 .  FIGS. 1, 2, and 5  show exemplary configurations for incorporating light emitting devices into a catheter. 
         [0112]    Light-generating apparatus  141  is based on an elongate and flexible multi-lumen catheter  140  that includes light emitting array  146  and a plurality of expandable members  142   a - 142   d . Light emitting array  146  preferably comprises a linear array of LEDs. As noted above, while four expandable members are shown, more or fewer expandable members can be employed, with at least two expandable members being particularly preferred. The materials and sizes of expandable members  142   a - 142   d  are preferably consistent with those described above in conjunction with multi-lumen catheter  130 . The walls of multi-lumen catheter  140  proximate to light emitting array  146  are formed of a flexible material that does not substantially reduce the transmission of light of the wavelengths required to activate the photoreactive agent(s) with which light-generating apparatus  141  will be used. As indicated above, bio-compatible polymers having the required optical characteristics can be beneficially employed, and appropriate additives can be used. Preferably, each expandable member is constructed of a material and inflated using a fluid that readily transmit light of the required wavelength(s). 
         [0113]    Referring to the cross-sectional view of  FIG. 14D  (taken along section line B-B of  FIG. 14C ), it can be seen that multi-lumen catheter  140  includes an inflation lumen  143   a  in fluid communication with expandable member  142   a , a second inflation lumen  143   b  in fluid communication with expandable members  142   b - c , a flushing lumen  144 , and a working lumen  149 . Again, if desired, each expandable member can be placed in fluid communication with an individual inflation lumen. Multi-lumen catheter  140  is configured so that flushing lumen  144  is in fluid communication with a port  148  (see  FIG. 14C ) formed in the wall of multi-lumen catheter  140 , which enables a flushing fluid to be introduced into portions  147   a - 147   c  of urethra  147  (i.e., into those portions distal of expandable member  142   a ). Those portions are isolated using inflation lumen  143   b  to inflate expandable members  142   b - 142   d . The flushing fluid is selected as described above. Working lumen  149  is sized to accommodate light emitting array  146 . Electrical leads  146   b  within working lumen  149  are configured to couple to an external power supply, thereby enabling the light source array to be selectively energized with an electrical current. A distal end  139  of multi-lumen catheter  140  includes an opening  160   a  in the catheter side wall configured to enable guidewire  145  (disposed outside of multi-lumen catheter  140 ) to enter a lumen (not shown) in the distal end of the catheter that extends between opening  160   a  and an opening  160   b , thereby enabling multi-lumen catheter  140  to be advanced over guidewire  145 . Note that it is also possible to create this device with a single lumen extrusion. For example, the LED array and connection wires could share the lumen with the inflation fluid. Each expandable member would also be in contact with this lumen through inflation ports cut into the extrusion. When the flushing fluid is provided it serves multiple functions—1) it cools the LEDs directly, 2) it provides good optical coupling between the LEDs and the outside of the catheter, and 3) it inflates the expandable members (all at the same time). This is a simpler version of the design, which does not require a multi-lumen catheter. 
         [0114]      FIG. 15  shows an alternative embodiment of the light-generating apparatus illustrated in  FIGS. 14A, 14B, 14C, and 14D . A light-generating apparatus  150  in  FIG. 15  is based on a multi-lumen catheter having an elongate, flexible body  154  formed from a suitable bio-compatible polymer and expandable members  152   a - 152   d . As indicated above, at least two expandable members are particularly preferred. The difference between light-generating apparatus  150  and light-generating apparatus  131  and  141 , which were discussed above, is that the expandable members in light-generating apparatus  150  are fabricated as integral portions of body  154 , while the expandable members of light-generating apparatus  131  and  141  are preferably implemented as separate elements attached to a separate catheter body. 
         [0115]    Yet another exemplary embodiment of a light generating catheter disclosed herein is configured to be used with an introducer catheter having a single lumen. A distal end of such a light generating catheter includes a linear light source array. This concept is schematically illustrated in  FIG. 16A . This exemplary embodiment has been designed to be used with an introducer catheter  240  having an inner diameter of 0.65 inches (1.65 mm) and an outer diameter of 0.050 inches (1.27 mm). It should be recognized however, that the dimensions disclosed herein are intended to be exemplary, and not limiting. A conventional guidewire  244  (i.e., not a light emitting guidewire, as discussed above) is disposed within a central lumen  242 , in introducer catheter  240 . In an exemplary embodiment, guidewire  244  has an outer diameter of 0.014 inches (0.36 mm). A light emitting catheter  246  is also disposed within central lumen  242 . A flexible light source array  248  is disposed in a distal end light emitting catheter  246 .  FIG. 16B  provides additional details relating to array  248 , which is generally similar to array  220  of  FIG. 13G , except for the use of a slightly thicker flexible substrate  222   d . Preferred dimensions for array  248  are a maximum width of 0.028 inches and a maximum height of 0.013 inches. 
         [0116]    Referring once again to  FIG. 16A , note that a push wire  250  is disposed under array  248 . Significantly, push wire  250  serves as a heat sink to enable heat from the LEDs in array  248  to be dissipated, significantly increasing the efficiency of the array (as measured by the amount of light output per LED—noting that cooler LEDs emit higher intensity light). Array  248  and push wire  250  are encapsulated in optically transparent potting material  218   a  (it should be apparent that the potting material need not be transparent to all wavelengths, but should at least be transparent to the wavelengths emitted by the light sources in array  248 ). The potting material need not extend the entire length of light emitting catheter  246 . Instead, the potting compound need only be disposed at the distal end of light emitting catheter  246 , such that array  248  is encapsulated. Thus, only a distal end of push wire  250  need be encapsulated in the potting compound. Note also that potting material  218   a  does not fill the entire interior of the distal end of light emitting catheter  246 . As a result, an annular lumen  252  is defined between the inner diameter of the light emitting catheter and the potting material encapsulating array  248 . Annular lumen  252  has a volume of at least 0.000177 cubic inches, so that if the distal end of light emitting catheter  246  is advanced distally of a distal end of introducer catheter  240 , a balloon can be incorporated into the distal end of light emitting catheter to surround the light source array (generally as discussed above), and annular lumen  252  will be sufficiently large to service such a balloon. Proximally of array  248 , annular lumen  252  significantly increases in size, since the only elements disposed in the lumen will be push wire  250  and the electrical conductors used to energize the array. The lumen in light emitting catheter  246  will be filled with a column of fluid. 
         [0117]      FIGS. 17-19  are cross-sectional views showing additional embodiments of portions of transurethral treatment devices.  FIG. 17 , more specifically, shows a device having a closed body support member  602  and a light delivery device fixed to the support member  602 . The light delivery device has a light generator  606   a , a light emitting region spaced apart from the light generator  606   a  distally along the support member  602 , and a light transmitting region  6   c  between the light generator  606   a  and the light emitting region  606   b . The light transmitting region  6   c  conducts light from the light generator  606   a  to the light emitting region  606   b .  FIG. 18  illustrates a device having a solid or otherwise lumen-less support member  602  and a light delivery device  6  with a light generator  606   a  and a light emitting region  606   b  at the same location longitudinally along the support member  602 . In  FIGS. 17 and 18 , the light generator is within the support member  602 .  FIG. 19  shows still another embodiment in which the light delivery device is on a surface of the support member. More specifically, the light delivery device  6  has the light generator  606   a  and the light emitting region  606   b  disposed on an external surface of the support member. 
         [0118]    In one embodiment, a light delivery system that is sized to fit into a standard or custom optically clear Foley catheter is inserted into that catheter which has been placed via the urethra at the prostate. The light delivery device can be used with a sterile Foley catheter or can be delivered in a sterile pack kit prepackaged with the catheter and/or an appropriate photoactive agent dose so that it is convenient for prostatic procedures. 
         [0119]    The light bar or light array may include a plurality of LEDs contained in a catheter assembly or otherwise attached to a closed elongated support member. The support member  602  may have an outer diameter of about 0.8 to about 10 mm. Example of LED arrays are disclosed in U.S. application Ser. No. 11/416,783 entitled “Light Transmission system for Photo-reactive Therapy,”, now U.S. Pat. No. 8,057,464 and U.S. application Ser. No. 11/323,319 entitled “Medical Apparatus Employing Flexible Light Structures and Methods for Manufacturing Same,” (now abandoned) herein incorporated in their entirety by reference. The die in these LED arrays can have a size range from about 0.152 mm to about 0.304 mm. One exemplary array can have the approximate dimensions of 0.3 mm in both length and width and 0.1 mm in thickness. 
         [0120]    Additional embodiments have a power controller drive circuit capable of producing constant current D.C., A.C., square wave and pulsed wave drive signals. This is accomplished by combining a constant source with a programmable current steering network allowing the controller to selectively change the drive wave form. For example, the steering network may be modulated to achieve the various functions described above, for example, producing the desired impedance to fully discharge the battery. Furthermore, use of an A.C. drive allows for a two-wire connection to the LEDs, thereby reducing the cross-sectional diameter of the catheter, while still permitting use of two back-to-back emission sources, that when combined, produce a cylindrical light source emission pattern. 
         [0121]    Therefore, as discussed above, the transurethral treatment device  621  can comprise a unitary, single use disposable system for light-activated drug therapy. It should be noted that in certain embodiments the catheter is fused to the power controller to form an integrated single unit. Any attempt to disconnect the support member in this embodiment results in damage to either the catheter, or module, or both. 
         [0122]    The prostate treatment system can be used in connection with any light-activated drug of which there are many known in the art and some of which are listed in U.S. Pat. No. 7,015,240 which is fully incorporated by reference with regard to disclosed photoactive compositions. In one particular embodiment, the light-activated drug is Talaporfin Sodium. Talaporfin Sodium is a chemically synthesized photosensitizer, having an absorption spectrum that exhibits a maximum peak at 664 nm. In one embodiment, the Talaporfin Sodium is presented as a lyophilized powder for reconstitution. One hundred milligrams of Talaporfin Sodium is reconstituted with 4 milliliters of 0.9% isotonic sterile sodium chloride solution, to give a solution at a concentration of 25 mg/ml. Another example provides 150 mg of Talaporfin Sodium to be reconstituted to the same 25 mg/ml concentration. 
         [0123]    The drug must be activated with light, and light energy is measured here in Joules (J) per centimeter of length of the light transmitting array. Likewise the fluence of light is measured in milli-watts (mW) per centimeter of length of the light emitting array. Clearly, the amount of energy delivered will depend on several factors, among them: the photoactive agent used, the dose administered, the type of tissue being treated, the proximity of the light array to the tissue being treated, among others. The energy (E) delivered is the product of the fluence (F) and the time period (T) over which the fluence is delivered: E=F×T. The fluence may be delivered for only a fraction of the treatment time, because the light array may be pulsed, for example in a frequency such as 60 kHz, or may be controlled by a timing pattern. An example of a timing pattern is that the array is at full fluence for 20 seconds, then off for 10 seconds in a repetitive cycle. Of course, any pattern and cycle that is expected to be useful in a particular procedure may be used. The control module may further be programmable in embodiments for such fractionated light delivery. 
         [0124]    In accordance with an embodiment, fifteen minutes to one hour following Talaporfin Sodium administration, light energy in the range from about 50 to about 1000 J/cm of light array fluence in the range from about 5 to about 50 mW/cm, 55 mW/cm, to about 100 mW/cm of light array is delivered to the treatment site. As may be expected, the equation discussed above relating energy time and fluence plays a role in selection of the fluence and energy delivered. For example, depending upon the patient, a certain time period may be selected as suitable. In addition, the nature of treatment might dictate the energy required. Thus, fluence F is then determined by F=E/T. The light array should be capable of providing that fluence in the allotted time period. For example, if a total of 200 J/cm of light array must be delivered to the treatment site at 20 mW/cm of light array, then the treatment period is approximately 2.8 hours (10,000 seconds). The 200 J/cm can also be delivered in approximately 60 minutes if the fluence is increased to approximately 55 mW/cm. 
         [0125]    In additional embodiments, the support member further has a selective coating to control where light transmits to the prostatic tissue thus directing the light activate drug therapy and reducing the potential to treat adjacent tissue. 
         [0126]    In another embodiment, the light delivery device is fixed in place in the catheter. In yet another embodiment, the light delivery device is movable within the catheter. According to this embodiment, the treatment device may further include printed markings or indicia on the catheter to aid in placement of the light bar within the catheter. The light delivery device can also have asymmetric light delivery to protect the colon or rectum. For example, the light deliver device can be double sided and/or shielded so that one side of the light bar emits light at a higher intensity than another side. Exemplary light delivery devices are disclosed in U.S. Pat. No. 5,876,427, herein incorporated in its entirety by reference. 
         [0127]    In additional embodiments, a Y-connection with a leakage control valve is included to allow the light transmission source to be inserted into the catheter through a separate lumen from a urine collection lumen. The catheter may include two or more lumens as needed to provide light transmission source manipulation and placement. 
         [0128]    In additional embodiments, the catheter includes a balloon or other positional element to further aid in positioning the light source transmission end proximate to the prostate using non-incision type methods. In additional embodiments, the catheter may include a retractable fixation device such as balloon, umbrella, tines, disk or other means for fixation and placement within the bladder. 
         [0129]    In additional embodiments, to make the light bar visible to ultrasound, the light source catheter and/or the light bar may include echogenic material to reflect high-frequency sound waves and thus be imageable by ultrasound techniques. In operation, echogenic material will aid in proper placement of the catheter and the light source. 
         [0130]    In additional embodiments, the light transmission source also includes temperature sensors which are electrically connected to temperature monitors. 
         [0131]    Several embodiments of the prostate treatment systems are expected to provide highly efficient, low cost, and minimally-invasive treatment of prostate conditions. The treatment device may be used to treat prostate cancer, prostatis, cystitis, bladder cancer, hypertrophic trigone, and hypertrophic urethral sphincter. The present invention utilizes light-activated drug therapy methods to minimally-invasively treat BPH or prostate cancer via the urethra. As a result patients with BPH or prostate cancer can be treated using the present invention without being hospitalized, undergo general anesthesia and blood transfusion, and thus have lower risk of complications. 
         [0132]    B. Methods of Treating BPH Using the Treatment Device 
         [0133]    The invention also provides methods of administering photoactive therapy to treat targeted tissue of a human or non-human patient. In one embodiment, the method includes identifying a location of tissue to be treated in the prostate; inserting a catheter into the urethra tract; inserting a light delivery device at least proximate to the location of the targeted tissue; and administering an effective dose of a photoactive drug. The method may include confirming placement of the light source prior to treatment. The method further includes treating the targeted tissue by activating the light delivery device for a predetermined period of treatment. In some embodiments, the light-activated drug is mono-L-aspartyl chlorine e.sub.6, also referred to herein as Talaporfin Sodium. Compositions and methods of making Talaporfin Sodium are disclosed and taught in co-pending U.S. Provisional Patent Application Ser. No. 60/817,769 entitled “Compositions and Methods of Making a Photoactive Agent” filed Jun. 30, 2006, herein incorporated in its entirety. This compound has an absorption spectrum that exhibits several peaks, including one with the excitation wavelength of 664 nm, which is the wavelength favored when it is used in photoreactive therapy. Alternative light-activated drugs of suitable excitation wavelengths may also be used as is known in the art. 
         [0134]    The method further includes monitoring a temperature at treatment site. The temperature measuring system includes a temperature sensor for monitoring the temperature at the treatment site. The temperature sensor may be a thermal couple or any suitable device for providing temperature information at the treatment site. The temperature sensor may be disposed at the surface of the support member and is further electrically connected to the temperature monitor via wires. Alternatively, the temperature sensor may be wirelessly connected to the temperature monitor. The temperature sensor provides the temperature proximate to the treatment site during treatment to ensure safe operating temperatures during the treatment at the treatment site. 
         [0135]    The above description of illustrated embodiments, including what is described in the Abstract, is not intended to be exhaustive or to limit the invention to the precise forms disclosed. Although specific embodiments of and examples are described herein for illustrative purposes, various equivalent modifications can be made without departing from the spirit and scope of the invention, as will be recognized by those skilled in the relevant art. The teachings provided herein of the invention can be applied to light sources, catheters and/or treatment devices, not necessarily the exemplary light sources, catheters and/or treatment devices generally described above. 
         [0136]    Unless the context requires otherwise, throughout the specification and claims which follow, the word “comprise” and variations thereof, such as, “comprises” and “comprising” are to be construed in an open, inclusive sense that is as “including, but not limited to.” 
         [0137]    Reference throughout this specification to “one embodiment” or “an embodiment” means that a particular feature, structure or characteristic described in connection with the embodiment is included in at least one embodiment of the present invention. Thus, the appearances of the phrases “in one embodiment” or “in an embodiment” in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments. The headings provided herein are for convenience only and do not interpret the scope or meaning of the claimed invention. 
         [0138]    The various embodiments described above can be combined to provide further embodiments. All of the U.S. patents, U.S. patent application publications, U.S. patent applications, foreign patents, foreign patent applications and non-patent publications referred to in this specification and/or listed in the Application Data Sheet, are incorporated herein by reference, in their entirety. Embodiments of the invention can be modified, if necessary, to employ systems, circuits and concepts of the various patents, applications and publications to provide yet further embodiments of the invention. 
         [0139]    These and other changes can be made to the invention in light of the above-detailed description. In general, in the following claims, the terms used should not be construed to limit the invention to the specific embodiments disclosed in the specification and the claims, but should be construed to include all catheters, light transmission sources and treatment devices that operate in accordance with the claims. Accordingly, the invention is not limited by the disclosure, but instead its scope is to be determined entirely by the following claims. 
         [0140]    From the foregoing, it will be appreciated that specific embodiments of the invention have been described herein for purposes of illustration, but that various modifications may be made without deviating from the spirit and scope of the invention. Accordingly, the invention is not limited except as by the appended claims.