Catheter system and catheter for activating photoactive agents - Patents.com

Abstract

The present disclosure generally relates to medical devices, systems, and methods for activating a photoactive agent during a medical procedure. In one aspect, a catheter system for activation of a photoactive agent may include a catheter having an elongate shaft including a proximal portion, a distal portion, and a first lumen extending along the elongate shaft. A first flexible circuit may be disposed about the distal portion of the elongate shaft. A plurality of first light emitting diodes (LEDs) may be disposed along the first flexible circuit. A second flexible circuit may be disposed about the distal portion of the elongate shaft. A plurality of second LEDs may be disposed along the second flexible circuit. A control unit may be coupled to a proximal end of the elongate shaft. A communication cable may be disposed within the catheter and may electrically connect the first LED to the control unit.

Description

[Technical Field]

[0001] FIELD OF THE DISCLOSURE The present disclosure relates generally to medical devices, systems, and methods for activating photoactive agents during medical procedures. [Background technology]

[0002] Photodynamic therapy (PDT) is a type of phototherapy that uses photosensitizing chemicals that are activated by light to cause tissue destruction. For example, a patient can be administered a photoactive agent that is absorbed by cancer cells. Treatment can involve directing light near the absorbed cancerous cells, activating the photoactive agent, and destroying the cancerous cells. PDT can have advantages over more invasive procedures, such as shorter recovery times. However, PDT carries the risk of damaging non-target tissue, for example, adjacent to the cancerous cells.

[0003] Light-delivering catheters may require cumbersome equipment and have limited maneuverability. Capital equipment available for treatment may provide a range of light with wavelengths that are too broad or too specific, limiting therapeutic efficacy. These difficulties may discourage PDT and reduce the availability of the service for patients. With these considerations in mind, the presently disclosed devices, systems, and methods for activating photoactive agents may be useful. Summary of the Invention

[0004] According to one aspect, a catheter system for activating a photoactive agent may include a catheter having an elongate shaft including a proximal portion, a distal portion, and a first lumen extending along the elongate shaft. A first flexible circuit may be disposed around the distal portion of the elongate shaft. A plurality of first light-emitting diodes (LEDs) may be disposed along the first flexible circuit. A second flexible circuit may be disposed around the distal portion of the elongate shaft. A plurality of second LEDs may be disposed along the second flexible circuit. A control unit may be coupled to the proximal end of the elongate shaft. A communication cable may be disposed within the catheter, the communication cable electrically connecting the first and second LEDs to the control unit. The control unit may include a battery power source and a controller including an integrated circuit electrically connected to the plurality of first and second LEDs configured to vary power supplied to the plurality of first and second LEDs. The controller may be configured to vary power supplied to the plurality of second LEDs independently of the first LED.

[0005] In various embodiments described herein and within the scope of the present disclosure, the proximal portion of the elongate shaft may include a first lumen. The first flexible circuit and the second flexible circuit may be spirally arranged around the distal end of the elongate shaft. A cross section of the catheter system taken perpendicular to the first lumen at one of the plurality of first LEDs may be present at one of the plurality of second LEDs. The controller may be configured to continuously vary power between the plurality of first LEDs and the plurality of second LEDs. The controller may be configured to continuously vary power up to a frequency of about 45 Hz. The first LED may be configured to emit light at a first wavelength, and the second LED may be configured to emit light at a second wavelength different from the first wavelength. The first LED may be configured to emit ultraviolet or visible light. At least one of the first LEDs may be configured to emit light at a frequency different from the frequency of light emitted by another of the first LEDs. A photodiode disposed on the first flexible circuit can be configured to detect light emitted from the first LED. A second lumen can extend through the proximal and distal portions of the elongate shaft. The second lumen can be configured to receive at least one of a guidewire, a photoactive agent, and a fluid to be delivered to the patient. The first lumen can extend along the proximal portion of the elongate shaft but cannot extend along the distal portion of the elongate shaft. A connector can be disposed on the control unit configured to connect the battery power source to a primary power source to charge the battery.

[0006] In one aspect, a catheter system for activating a photoactive agent may include a catheter for activating a photoactive agent including an elongate shaft. The elongate shaft may include a proximal end, a distal end, and a first lumen therethrough. A plurality of circuits may be helically disposed around the distal end of the elongate shaft. A plurality of light-emitting diodes (LEDs) may be disposed along each of the plurality of circuits. A communication cable may be disposed within the first catheter lumen and may be independently electrically coupled to each of the plurality of circuits such that each of the plurality of circuits is independently operable.

[0007] In various embodiments described herein, and other embodiments within the scope of the present disclosure, a cross section of the catheter taken perpendicular to the lumen at one of the plurality of LEDs may be present for each of the plurality of circuits. The LED of one of the plurality of circuits may be configured to emit light at a wavelength different from the wavelengths of the LEDs of the remaining plurality of circuits. A photodiode may be disposed in one of the plurality of circuits configured to detect light emitted from the plurality of LEDs. A communication cable may be configured to transmit power independently and sequentially between each of the plurality of circuits.

[0008] In one aspect, a method for activating a photoactive agent may include introducing the photoactive agent into a patient's tissue. A catheter including a first plurality of light-emitting diodes (LEDs) and a second plurality of LEDs may be inserted into the patient's body toward the tissue. The photoactive agent may be irradiated by continuously varying the power supplied to the first plurality of LEDs and the second plurality of LEDs. Tissue temperature may be monitored. The power supplied may be varied based on the monitoring. The photoactive agent may be locally introduced into the tissue. The photoactive agent may be intravenously introduced into the patient. The tissue may be selected from bladder tissue, pancreatic tissue, esophageal tissue, and lung tissue. Light emitted from either the first or second plurality of LEDs may be sensed via a photodiode. The photoactive agent may include one of an anti-cancer compound and a photo-hardening agent or a photo-crosslinking agent. The photoactive agent may include tetra(hydroxyphenyl)chlorin (mTHPC) and may be introduced intravenously. Irradiation may occur about two to about five days later. The tissue may be bladder tissue, and the method may further include diagnosing cancer based on the effect of the photoactive agent after irradiation. The photoactive agent may include 5-aminolevulinic acid (ALA) configured for photodynamic therapy (PDT). The catheter may be inserted through an endoscope. The power may be continuously varied at a frequency of about 45 Hz. [Brief explanation of the drawings]

[0009] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate various exemplary embodiments and, together with the description, serve to explain the principles of the disclosed embodiments. [Figure 1A] 1 illustrates a flexible circuit having light emitting diodes (LEDs) according to one embodiment of the present disclosure. [Figure 1B] 1B shows two of the flexible circuits of FIG. 1A arranged together around a shaft, according to one embodiment of the present disclosure. [Figure 1C] 1B illustrates a catheter system including the flexible circuit of FIG. 1A according to one embodiment of the present disclosure. [Figure 1D] 1D shows the catheter system of FIG. 1C from another perspective. [Figure 2A] 1 shows a catheter for activating a photoactive agent according to one embodiment of the present disclosure. [Figure 2B] 2B shows a cross-sectional view of the catheter of FIG. 2A. [Figure 3] 1 illustrates a catheter system for activating a photoactive agent, according to one embodiment of the present disclosure. [Figure 4] 1 illustrates a catheter system for activating a photoactive agent used during a procedure, according to one embodiment of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0010] Detailed Description The detailed description should be read with reference to the drawings, which are not necessarily to scale, depict illustrative embodiments and are not intended to limit the scope of the invention.

[0011] As used herein, "proximal end" refers to the end of the device along the device that is closest to the medical professional when introducing the device into a patient, and "distal end" refers to the end of the device or object along the device that is farthest from the medical professional during implantation, positioning, or delivery.

[0012] As used in this specification and the appended claims, the singular forms "a," "an," "the," and "said" include plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term "or" is used in its general sense including "and / or" unless the content clearly dictates otherwise.

[0013] References herein to "one embodiment," "some embodiments," "other embodiments," etc., indicate that the described embodiment may include one or more particular features, structures, and / or characteristics. However, such a description does not necessarily mean that all embodiments include that particular feature, structure, and / or characteristic. Furthermore, if a particular feature, structure, and / or characteristic is described in connection with one embodiment, it should be understood that such feature, structure, and / or characteristic may also be used in connection with other embodiments, whether or not explicitly stated, unless expressly stated to the contrary.

[0014] As used herein, all numerical values ​​are deemed to be modified by the term "about," whether or not explicitly stated. The term "about" in the context of numerical values ​​generally refers to a range of numerical values ​​that one of ordinary skill in the art would consider equivalent to the recited value (i.e., having the same function or result). In many cases, the term "about" can include numerical values ​​that are rounded to the nearest significant figure. Other uses of the term "about" (i.e., in contexts other than numerical values) can be assumed to have the ordinary and customary definition understood from and consistent with the context of the specification, unless otherwise specified. The recitation of numerical ranges by upper and lower limits includes all numbers within that range, inclusive of the upper and lower limits (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

[0015] As used herein, the term "target tissue" refers to an unhealthy, diseased (i.e., cancerous, precancerous, etc.) or otherwise undesirable portion of tissue, which may be healthy or unhealthy. Target tissue may also include tissue that is suspected of being unhealthy or diseased, but for which confirmation of the diseased status by biopsy is required.

[0016] Many medical procedures, including those along the gastrointestinal, urinary, or respiratory systems, involve the delivery of photoactive agents to target tissues. Photoactive agents can be photoactivated to provide therapy at or near the target tissue. For example, PDT is a cancer treatment method based on a photochemical reaction between photoactivated molecules or photosensitizers. In the presence of such photosensitizers, light of specific wavelengths and oxygen molecules form reactive oxygen species (ROS), which can damage nearby cells and trigger inflammatory or immune responses. Such photosensitizers can include, for example, talaporfin sodium for the treatment of esophageal cancer and alpha-lipoic acid for the treatment of bladder cancer.

[0017] PDT may be ineffective in portions of target tissue at depths where light penetration is difficult or dangerous. For example, problems may arise when activating photoactive agents at depths greater than, for example, about 10 mm from the tissue surface. Precise wavelength radiation delivery, detection, and management may reduce the complications of providing treatment at such depths.

[0018] Referring to FIG. 1A , a flexible circuit 102 according to one embodiment of the present disclosure is shown. The circuit 102 includes twelve LED mounts 104 electrically connected in series. While twelve LEDs are shown, any number of LEDs, such as 1, 2, 3, 4, 5, 6, 8, 10, 15, 20, 30, 50, 100, etc., can be used in various embodiments. One end of the circuit 102 includes a connector 130 having lead contacts 132, 134, and 136 for electrical communication with components of the circuit 102. The connector 130 includes a supply lead contact 132, a return lead contact 134, and a sense lead contact 136. The lead contacts 132, 134, and 136 are configured to connect to a controller, power source, and / or receiver for operation and feedback of the circuit 102. The end of the circuit 102 including the connector 130 extends at an oblique angle away from an axis α that extends parallel to a central portion 140 of the circuit 102. A pair of sensor mounting points 138 (e.g., a pair of photodiodes) are used to sense one or more parameters of the system, such as wavelength, power, temperature, pH, etc., and are located in a central location along the circuit 102. Although only a pair of sensor mounting points 138 are shown centrally along the circuit 102, in various embodiments, additional or alternative sensor mounting points 138 may be employed and may be located anywhere along the circuit 102. The circuit 102 may include a heat sink material, such as copper, which may or may not be used as part of the electrical circuitry.

[0019] Referring to FIG. 1B, two flexible circuits 102 of FIG. 1A are shown in accordance with one embodiment of the present disclosure. The two flexible circuits 102 are arranged in a spiral around the longitudinal axis 1 such that the flexible circuits 102 are parallel to one another. While two flexible circuits 102 are shown, in various embodiments, any number of flexible circuits 102 can be used, e.g., 1, 3, 4, 5, 8, 10, 15, 20, 50, etc. The flexible circuits 102 can extend around a device (e.g., a catheter, etc.) extending along the longitudinal axis 1. While the flexible circuits 102 are shown with a gap between them, in alternative embodiments, there may be no gap, or the flexible circuits 102 may partially overlap. The ends of the flexible circuits 102 with connectors 130 are oriented toward the same end of the longitudinal axis 1 so as to allow electrical connection to a wire and / or one or more connectors. The ends of the flexible circuit 102 with the connectors 130 extend at an oblique angle away from the central portion 140 of the flexible circuit 102 (i.e., as shown in FIG. 1A ), allowing the central portion 140 to be spirally positioned about the longitudinal axis 1 without significant folds, wrinkles, bends, etc. Each of the two flexible circuits 102 may be separately coupled, for example, to a controller, such that the supply of power may be independently varied between one flexible circuit 102 and another flexible circuit 102. One or more of the flexible circuits 102 may be positioned to have an outer diameter that fits within the working channel of a scope, for example, an outer diameter of less than about 2.8 mm.

[0020] 1C and 1D, a catheter system including the flexible circuit 102 of FIG. 1A is shown in accordance with one embodiment of the present disclosure. The system includes a catheter 100 with an elongate shaft having a proximal portion 100p and a distal portion 100d. The proximal portion 100p has an outer diameter larger than the outer diameter of the distal portion 100d. A first lumen 142 extends along the catheter 100 and accommodates a guidewire 150, although other devices and / or fluids may additionally or alternatively extend through the first lumen 142. The flexible circuit 102 is spirally disposed around the distal portion 100d of the catheter 100. While one flexible circuit 102 is shown in FIGS. 1C and 1D, it should be understood that any number of flexible circuits 102 may be used, for example, two or more flexible circuits 102 as shown in the configuration of FIG. 1B. The LEDs 104 are spaced along the first flexible circuit 102 in a substantially uniform array around the distal portion 100d. The proximal portion 100p of the catheter 100 includes a second lumen 144. A communication cable 146 (e.g., a wire) is disposed within the second lumen 144 and can electrically connect the LEDs 104 to a control unit. The second lumen has a non-circular shape (e.g., rectangular, C-shaped, crescent-shaped, etc., but can also be circular) compared to the first lumen 142 to better accommodate multiple communication cables 146 compared to the close-fitting circular first lumen 142 that accommodates the guidewire 150. The communication cable 146 can be connected to each of the supply lead contact 132 and the return lead contact 134. A sensor 148 is disposed along the flexible circuit 102 approximately at the center of the array of LEDs 104. An additional communication cable 146 can be connected to the sensing lead contact 136. The sensor 148 may be, for example, a photodiode, thermistor, pH sensor, pulse oximeter, etc., and provides feedback to a controller and / or user in the area of ​​the patient along the LED 104 before, during, and / or after treatment.

[0021] Referring to FIG. 2A, a catheter 200 for activating a photoactive agent according to one embodiment of the present disclosure is shown. The portion of the catheter 200 shown is the distal portion of the catheter 200. Three circuits 202 are spirally arranged around the distal portion of the catheter 200. Although three flexible circuits 202 are shown, any number of flexible circuits 202, e.g., 1, 2, 4, 5, 8, 10, 15, 20, 50, etc., can be used in various embodiments. Multiple LEDs 204 are arranged along each circuit 202. The LEDs 204 between adjacent circuits 202 are aligned parallel to the longitudinal axis 1 of the catheter 200. The cross-section of the catheter 200 shown in FIG. 2B is taken perpendicular to the longitudinal axis 1 at each of the LEDs 204 of the three circuits 202 so that the LEDs 204 of each circuit 202 coincide with cross-section 2B. A lumen 242 extends through the catheter 200. Lumen 242 may accommodate a guidewire and / or other devices and / or fluids. One or more communication cables independently electrically coupled to each of circuits 202 may be disposed within lumen 242 and / or extend through catheter wall 206 to each of circuits 202. Each of the three circuits 202 is independently electrically connected to a power source and / or controller, such that each of the three circuits 202 is independently operable.

[0022] In various embodiments herein, for example, one or more LEDs or one or more sets of LEDs along one or more circuits may be independently activated and / or powered. The treatment target location, target tissue, or adjacent tissue may be undesirably affected, such as being heated by one or more LEDs. To mitigate or suppress the undesirable effects of LED emission, one or more circuits may be activated or deactivated. Such activation and deactivation may be achieved by independently controlling the circuits. Circuits may be activated and deactivated sequentially (e.g., in a patterned manner) so that LED emission is uniformly applied to the treatment area (e.g., around or along the longitudinal axis). For example, one spiral circuit may be operated at a certain power for a period of time, and then deactivated or its power reduced while an adjacent spiral circuit is activated or its power increased. In this example, effective LED emission from the collective circuit may be maintained without exceeding undesirable emission from a particular LED or circuit (e.g., causing LED overheating or light oversaturation). Additionally or alternatively, LEDs between different circuits may have variable wavelengths. Such LED or circuit illumination may be monitored by one or more sensors along one or more circuits. Activation, deactivation, power increase, or power decrease may be performed manually or automatically by a controller. For example, the controller may oscillate power to the LEDs of a circuit or between LEDs of different circuits in an oscillating manner such that continuous light is emitted without the LEDs overheating during operation.

[0023] Referring to FIG. 3, a catheter system according to one embodiment of the present disclosure is shown. The system includes a catheter 300, which is an elongated shaft having a proximal portion 300p and a distal portion 300d. A circuit 302 is disposed along the distal end 300d. The circuit 302 includes twelve LEDs 304, although any number, e.g., 1, 2, 5, 10, 20, 50, etc., can be used in various embodiments. A control unit 350 is coupled to the proximal end of the catheter 300. The control unit 350 is ergonomically shaped for easy handling in a user's hand. The control unit 350 includes a battery power source (e.g., two 9V batteries within the control unit 350, not shown) connected to a circuit board 352 operable by a switch 354. The circuit board 352 within the control unit includes an integrated circuit controller electrically connected to the LEDs 304 by a communication cable 346. The circuit controller can vary the power supplied to the plurality of first LEDs 304 or adjust the intensity of the plurality of first LEDs 304 by adjusting the analog knob 356. Alternatively, the knob 356 may be configured to switch between the plurality of circuits 302 of the LEDs 304 or adjust the oscillation speed or power level. Indicator LEDs 358 may indicate to the user the status of the system, for example, whether the system is powered on or off, whether some or all of the LEDs 304 are activated or deactivated, or system parameters such as heat, wavelength, treatment duration, oscillation, etc. The control unit 350, including the battery power supply and user-interactive controls, may facilitate easier system operation and adjustment compared to systems connected to stationary capital equipment. The battery power supply may be configured to removably connect to a mains power source to recharge the battery power supply or may be removably replaced. While a catheter 300 is shown in FIG. 3 , it should be understood that any catheter described herein can be coupled to the control unit 350 and operate in a substantially similar manner.

[0024] Referring to Figure 4, a catheter system for activating a photoactive agent 460 during a procedure is shown, according to one embodiment of the present disclosure. A catheter 400 is inserted through a male urethra 462 into a bladder 464. The catheter 400 includes an LED 404 disposed about a distal portion 400d of the catheter 400. The LED 404 is active and emits light 466 (which may or may not be in the visible spectrum). The light 466 is received by the photoactive agent 460 on or within the body cavity tissue of the bladder 464.

[0025] In various embodiments, the LEDs can be any shape, such as rectangular, oval, circular, elliptical, combinations thereof, etc. Additionally or alternatively, multiple LEDs can be arranged in any shape, including a triangle (e.g., three LEDs at a 120-degree angle relative to each adjacent LED), a square (e.g., four LEDs at an angle relative to each adjacent LED), and / or an in-line orientation with each LED facing a different direction. Light emitted from the LEDs can be emitted across a transparent or translucent layer adjacent to the LEDs. This layer can be a coating, such as an electrically insulating heat shrink or another substance, e.g., a curable substance such as an adhesive, that can be disposed along one or more portions of the circuit along the catheter. One or more LEDs can be arranged in multiple rows, e.g., two or more rows parallel or substantially parallel to the longitudinal axis, and / or circumferentially arranged around the axis. The LEDs can extend completely or partially circumferentially.

[0026] In various embodiments, the LEDs can extend along a portion of the length of the catheter. The LEDs can be arranged in various patterns along the elongate member, such as helically, axially, radially, circumferentially, linearly, intermittently spaced, randomly, at various densities along the length, or combinations of these arrangements. This allows the LEDs to emit light along one or more radial angles from the longitudinal axis of the catheter. Light emitted from activated LEDs can affect the photoactive agent and / or tissue (e.g., to ablate tissue). The LEDs can emit light of varying wavelengths, such as non-visible light (e.g., infrared or ultraviolet light), or visible light between about 200 nm and about 700 nm, such as red or green, that can have different effects on the photoactive agent and / or tissue. The LEDs can be operated at various frequencies by pre-programming or manual control by a user. The LEDs can be individually selectable and controllable as single LEDs or as a series of more than one LED. The LEDs may be controllable by one or more parameters such as density, position of the LEDs relative to each other, anatomical structure, medical device, size, shape, frequency of activation, associated photoactive agent, intensity of activation (e.g., using current with pulse width modulation (PWM) operating at a duty cycle that affects the desired frequency and / or LED intensity), activation time, color, or any combination thereof.

[0027] In various embodiments, multiple sets of LEDs can be arranged in various patterns along and / or around the catheter. For example, a first set can be arranged along a first section, and a second set (and / or additional sets) can be arranged along a second section opposite the first section. As another example, a first set can be arranged spirally around the catheter, and a second set (and / or additional sets) can be arranged spirally around the catheter adjacent to the first set. The sets of LEDs can be operated independently. For example, they can be blinked (i.e., powered on and off, or powered on and then powered down, etc.) in a pattern. For example, the LEDs can blink at about 45 Hz with a duty cycle of about 30% to about 75% and a current of about 30 mA. In various embodiments, the LEDs can be selected for the device depending on the treatment and / or photoactive agent being used.

[0028] In various embodiments, the device may include multiple wires, e.g., a positive wire connection to each LED anode terminal and a common cathode return terminal wire (for each individual LED or set of LEDs), to transfer electrical energy from a power source (e.g., a generator, battery pack, or similar energy source) to provide control. The wires may also include sensor wires. For example, the wires may be contained within a lumen or layer of the catheter and / or the wires may extend along the outer surface of the catheter. The wires may also be insulated, e.g., with a biocompatible polymer.

[0029] In various embodiments, the distal end of the device may include a disperser in addition to or instead of one or more LEDs. The disperser may attenuate and / or diffuse the light emitted from the one or more LEDs. In various embodiments, a plastic or glass diffusing light pipe may extend along the catheter. The catheter may include reflective surfaces along its length to direct light to the distal end of the catheter. For example, a light source may be coupled to the proximal end of the catheter.

[0030] In various embodiments, the controller can be electrically coupled to the LEDs along the catheter. Electrical leads can be interleaved to electrically connect with the LEDs so that the LEDs can operate independently or independently within a series of LEDs. The controller can be configured to sequentially operate one or more LEDs at a time. The controller can be configured to sequentially operate the LEDs so that only a single LED or multiple LEDs are operated at a time, e.g., sequentially operating LEDs along a first portion of the catheter and then LEDs along a second portion of the catheter. The controller can be configured to operate the LEDs at a higher frequency and for a shorter illumination time (e.g., at a lower duty cycle, where the LEDs are illuminated a smaller percentage of the time) to reduce heat compared to LEDs operated at a lower frequency and for a longer illumination time (e.g., at a higher duty cycle, where the LEDs are illuminated a larger percentage of the time). The controller can be configured to operate some of the LEDs at a first frequency and another portion of the LEDs at a second frequency, e.g., operating a distal portion of the LEDs at a higher frequency than a proximal portion of the LEDs. The LEDs may extend along the length of the elongate member a distance that substantially conforms to the patient's anatomy. A controller may be manually or automatically operated to activate one or more LEDs and to switch between various operating patterns. Activation of such LEDs may be shortened to reduce heat. The LEDs and / or activation times of such LEDs described herein may reduce ambient heat in the system compared to other technologies and may activate photoactivators in shorter times than other technologies (e.g., compared to light bulbs, lasers, etc.).

[0031] In various embodiments throughout the present disclosure, a method for activating a photoactive agent may include introducing the photoactive agent into or toward a patient's tissue. A catheter having a first plurality of LEDs and a second plurality of LEDs may be inserted into the patient's body toward the tissue. The photoactive agent may be irradiated by continuously varying the power supplied to the first plurality of LEDs and the second plurality of LEDs. Tissue temperature may be monitored, and the power supplied may be varied based on the monitoring. The photoactive agent may be locally introduced into the tissue. The photoactive agent may be intravenously introduced into the patient. The tissue may be bladder tissue, pancreatic tissue, esophageal tissue, lung tissue, etc. Light may be emitted from the first and / or second plurality of LEDs. The photoactive agent may include one of an anti-cancer compound and a photo-hardening agent or photo-crosslinking agent, etc. The photoactive agent may include tetra(hydroxyphenyl)chlorin (mTHPC) and may be introduced intravenously. Irradiation may occur about two to about five days later. The photoactive agent may be introduced into a catheter containing LEDs and activated thereafter or simultaneously within the same procedure. The tissue may be bladder tissue. Diagnosis of cancer can be performed based on the effect of the photoactive agent after irradiation. The photoactive agent may include 5-aminolevulinic acid (ALA) configured for photodynamic therapy (PDT). Hexvix® Blue Light Cystoscopy (BLC) can be used as a diagnostic method for bladder cancer patients. A catheter can be inserted through the endoscope. Power can be continuously varied at a frequency of approximately 45 Hz.

[0032] It will be apparent to those skilled in the art that various modifications and variations can be made to the disclosed devices without departing from the scope of the present disclosure. For example, the configuration of the device for activating the photoactive agent can be varied to suit any medical therapy. It will be understood that the number and / or location of LEDs is not limited to the examples set forth herein. Other embodiments of the present disclosure will be apparent to those skilled in the art from consideration of the specification and practice of the invention disclosed herein. It is intended that the specification and examples be considered as exemplary only, with the true scope and spirit of the invention being indicated by the following claims.

Claims

1. 1. A catheter system for activating a photoactive agent, comprising: an elongate shaft including a proximal portion, a distal portion, and a first lumen extending along the elongate shaft, the first lumen extending through the proximal portion of the elongate shaft and the distal portion of the elongate shaft, the first lumen configured to receive at least one of a guidewire, the photoactive agent, and a fluid to be delivered to a patient; a first flexible circuit disposed about the distal portion of the elongate shaft; a plurality of first light emitting diodes (LEDs) disposed along the first flexible circuit; a second flexible circuit disposed about the distal portion of the elongate shaft; a plurality of second LEDs disposed along the second flexible circuit; and a second lumen extending through the proximal portion of the elongate shaft but not through the distal portion of the elongate shaft; a catheter including: a control unit coupled to a proximal end of the elongate shaft; a communication cable disposed within the second lumen and electrically connecting the first and second LEDs to the control unit; and Including, the control unit includes a battery power source and a controller including an integrated circuit electrically connected to the plurality of first and second LEDs, the controller configured to vary power supplied to the plurality of first and second LEDs; The catheter system, wherein the controller is configured to vary the power supplied to the plurality of second LEDs independently of the first LED.

2. The catheter system of claim 1 , wherein the first flexible circuit and the second flexible circuit are helically disposed around the distal end of the elongate shaft.

3. 2. The catheter system of claim 1, wherein one of the second LEDs is present in a cross section of the catheter system taken perpendicular to the first lumen at one of the first LEDs.

4. The catheter system of claim 1 , wherein the controller is configured to independently and sequentially transfer power between the first plurality of LEDs and the second plurality of LEDs.

5. The catheter system of claim 4 , wherein the controller is configured to continuously vary the power up to a frequency of about 45 Hz.

6. 10. The catheter system of claim 1, wherein the first LED is configured to emit light at a first wavelength and the second LED is configured to emit light at a second wavelength different from the first wavelength.

7. 10. The catheter system of claim 1, wherein at least one of the first LEDs is configured to emit light at a frequency that is different from a frequency of light emitted by another of the first LEDs.

8. The catheter system of claim 1 , further comprising a photodiode disposed on the first flexible circuit configured to detect light emitted from the first LED.

9. The catheter system of claim 1 , wherein the second lumen has a non-circular cross-section.

10. The catheter system of claim 1 , wherein the second lumen has a C-shaped or crescent-shaped cross section.

11. The catheter system of claim 1 , wherein the communication cable is configured to transmit power independently and sequentially between each of the first and second flexible circuits.

12. 1. A catheter for activation of a photoactive agent, comprising: an elongate shaft including a proximal end, a distal end, and a lumen extending through the proximal portion of the elongate shaft but not through the distal portion of the elongate shaft; a plurality of circuits helically arranged around the distal portion of the elongate shaft; a plurality of light emitting diodes (LEDs) disposed along each of the plurality of circuits; a communications cable disposed within the lumen and independently electrically coupled to each of the plurality of circuits such that each of the plurality of circuits is independently operable, the communications cable being configured to independently sequentially transfer power between each of the plurality of circuits. a catheter.

13. 13. The catheter of claim 12, wherein a cross section of the catheter taken perpendicular to the lumen at one of the plurality of LEDs is present for each LED of the plurality of circuits.

14. 13. The catheter of claim 12, wherein the LEDs of one of the circuits are configured to emit light at a wavelength different from the wavelengths of the LEDs of the remaining circuits.

15. The catheter of claim 12, further comprising a photodiode disposed in one of the plurality of circuits configured to detect light emitted from the plurality of LEDs.

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