Catheter with energy emitter for treating lesion in blood vessel

Abstract

A multimodal catheter (10) for treating a lesion treatment site in a blood vessel by enhancing uptake of an active agent into the lesion treatment site includes a drug-coated balloon (20) and an energy emitter (24), such as an ultrasound transducer or electrode for generating an electric pulse. The energy emitter emits energy from adjacent the distal end of the catheter body to the lesion treatment site to enhance delivery or uptake of the active agent at the lesion treatment site as the active agent is released from the drug-coated balloon. Another catheter (110) includes an energy emitter (124) suitable to modify the lesion to reduce inflammation and promote healing and stabilization of the lesion to inhibit the lesion from separating or dislodging from the blood vessel wall. The catheter may also include a drug-coated balloon.

Description

CATHETER WITH ENERGY EMITTERFOR TREATING LESION IN BLOOD VESSELFIELD

[0001] The present technology is generally related to a catheter including an energy emitter for treating a lesion in a blood vesselBACKGROUND

[0002] Traditional angioplasty involves using a balloon catheter to dilate a narrowed artery by inflating an angioplasty balloon at the site of a lesion (e.g., plaque) causing a blockage in an artery. A limitation of conventional angioplasty is the occurrence of restenosis, where the treated artery can narrow again due to the proliferation of smooth muscle cells and the formation of scar tissue, which may be a response to the injury caused by the procedure.

[0003] To address these concerns, drug-coated balloons (i.e., DCBs) were developed, drug-coated balloons are coated with an anti-proliferative or anti-restenotic drug, such as paclitaxel or sirolimus, which is released onto the vessel wall at the treatment site during balloon inflation. The drug prevents excessive cell growth and reduces the risk of restenosis by targeting the cells responsible for the narrowing of the artery. The mechanism of action involves the temporary contact of the drug with the vessel wall, allowing for a controlled and localized release of the drug at the treatment site. This targeted drug delivery system through use of a balloon aims to inhibit cell proliferation and reduce inflammation, promoting healing and reducing the recurrence of blockages.

[0004] Achieving consistent and uniform drug delivery to the arterial wall using drug- coated balloons can be challenging. Factors like balloon inflation time, over-inflation, drug coating quality, and vessel characteristics may affect the uniformity and efficiency of drug delivery, potentially impacting treatment outcomes.

[0005] In addition, certain blood vessel lesions may not be suitable or optimal for angioplasty or atherectomy treatment. Such lesions may be partially occluding less than an amount suitable for conventional treatments (e.g., less than 50% blockage). These lesions, however, may still be problematic for the patients.SUMMARY

[0006] The techniques of this disclosure generally relate to, among others, a multimodal catheter and method for treating a lesion in a blood vessel by enhancing uptake of an active agent into the lesion treatment site. In addition, the techniques of this disclosure generally relate to a catheter and method including an energy emitter suitable to modify the lesion to reduce inflammation and promote healing and stabilization of the lesion to inhibit the lesion from separating or dislodging from the blood vessel wall.

[0007] In one aspect, the present disclosure provides a catheter for treating a lesion treatment site in a blood vessel. The catheter comprises a catheter body having opposite proximal and distal ends and a length extending between the proximal and distal ends. A drug-coated balloon is coupled to the catheter body adjacent the distal end thereof. The drug-coated balloon is configured to deliver an active agent to the lesion treatment site. An energy emitter is coupled to the catheter body. The energy emitter is configured to emit energy from adjacent the distal end of the catheter body to the lesion treatment site to enhance delivery or uptake of the active agent at the lesion treatment site as the active agent is released from the drug-coated balloon.

[0008] In another aspect, the disclosure provides a catheter for treating a lesion treatment site in a blood vessel. The catheter comprises a catheter body having opposite proximal and distal ends and a length extending between the proximal and distal ends. A light energy emitter is coupled to the catheter body adjacent the distal end thereof. The light energy emitter is configured to emit light energy to the lesion treatment site to reduce inflammation and promote stabilization of the lesion treatment site.

[0009] In yet another aspect, the disclosure provides a method of treating a lesion treatment site in a blood vessel. The method comprises inserting a catheter body of a catheter into the blood vessel. A drug-coated balloon and an energy emitter are coupled to the catheter body. The energy emitter is configured to emit energy from adjacent the distal end of the catheter body. The drug-coated balloon and the energy emitter are positioned adjacent the lesion treatment site. The drug-coated balloon is inflated so that the drug- coated balloon is in apposition with the lesion treatment site and an active agent is released from the balloon and delivered to the lesion treatment site. The energy emitter is activated to emit energy to the lesion treatment site. The emitted energy is absorbed by the lesiontreatment site to enhance delivery or uptake of the active agent at the lesion treatment site as the active agent is released from the drug-coated balloon.

[0010] In another aspect, the disclosure provides a method of treating a lesion treatment site in a blood vessel. The method comprises inserting a catheter body of a catheter into the blood vessel. A light energy emitter is coupled to the catheter body. The light energy emitter is configured to emit energy from adjacent the distal end of the catheter body. The energy emitter is positioned adjacent the lesion treatment site. The light energy emitter is activated to emit light energy to the lesion treatment site. The emitted light energy is absorbed by the lesion treatment site to reduce inflammation and promote stabilization of the lesion treatment site.

[0011] The details of one or more aspects of the disclosure are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the techniques described in this disclosure will be apparent from the description and drawings, and from the claims.BRIEF DESCRIPTION OF DRAWINGS

[0012] FIG. 1 is a side elevation of an embodiment of a multimodal catheter including a drug-coated balloon and an energy emitter for enhancing drug uptake or delivery at a lesion treatment site in a blood vessel.

[0013] FIG. 2 is a schematic of the multimodal catheter of FIG. 1 received in a blood vessel and treating a lesion treatment site using the drug-coated balloon and the energy emitter.

[0014] FIG. 3 is a side elevation of a catheter including a light energy emitter at a distal end thereof, the catheter being free from a balloon.

[0015] FIG. 4 is a schematic of the catheter of FIG. 3 received in a blood vessel and treating a lesion treatment site using the light energy emitter.

[0016] FIG. 5 is a side elevation of a multimodal catheter including a drug-coated balloon and light energy emitters disposed in the balloon.

[0017] FIG. 6 is a schematic of the multimodal catheter of FIG. 5 received in a blood vessel and treating a lesion treatment site using the drug-coated balloon and the light energy emitters.

[0018] FIG. 7 is side elevation of a multimodal catheter including a drug-coated balloon and electrodes disposed in the balloon.

[0019] FIG. 8 is a schematic of the multimodal catheter of FIG. 7 received in a blood vessel and treating a lesion treatment site using the drug-coated balloon and electric pulse(s) generated by the electrodes.

[0020] FIG. 9 is side elevation of a multimodal catheter including a drug-coated balloon and electrodes disposed outside the balloon.DETAILED DESCRIPTION

[0021] The present disclosure describes a catheter and method for treating a lesion in a blood vessel.

[0022] One disclosed embodiment is a multimodal catheter and method for treating a lesion in a blood vessel by enhancing uptake of an active agent into the lesion treatment site. Conventionally, a lesion in a blood vessel may be treated with a drug-coated balloon (DCB). However, it may be difficult to achieve consistent and uniform drug delivery to the blood vessel wall using drug-coated balloons. Factors like balloon inflation time, overinflation, drug coating quality, and vessel characteristics may affect the uniformity and efficiency of drug delivery, potentially impacting treatment outcomes. Accordingly, multimodal catheter embodiments of the present disclosure enhance uptake or delivery of an active agent to the lesion treatment site to promote consistent treatment and positively impact patient outcome.

[0023] Another disclosed embodiment is a catheter including an energy emitter suitable to modify the lesion to reduce inflammation and promote healing and stabilization of the lesion to inhibit the lesion from separating or dislodging from the blood vessel wall. As an example and as described below, the energy emitter may emit light energy, such as near infrared light, for example. This light energy is absorbed by the lesion and / or the blood vessel wall at the lesion to reduce inflammation, remove oxidative particles, and promote healing and stabilization of the lesion, as described in more detail below.

[0024] Referring to FIG. 1, an embodiment of a multimodal catheter for enhancing or facilitating drug uptake into a lesion treatment site of a blood vessel is generally indicated at reference numeral 10. The catheter 10 includes a catheter body 12 sized and shaped for insertion into and tracking through a selected blood vessel, such as an artery. As a non-limiting example, the catheter body 12 may have a diameter from about 1 mm to about 10 mm and a length from about 50 cm to about 150 cm. The catheter body 12 may be formed from a suitable polymer providing suitable flexibility and trackability. In a non-limiting example, the catheter body 12 may be formed from a suitable polyethylene, nylon, or blends thereof. The catheter body 12 may be formed from other materials. The catheter body 12 may define or otherwise include a guidewire lumen 14 (FIG. 2) for receiving guidewire G therein. The guidewire lumen 14 may be compatible with a suitable conventional guidewire G, such as a 0.014 in, 0.018 in, or 0.035 in guidewire. As would be understood by those in the art, the guidewire G is used to deliver the catheter body 12 to the treatment site.

[0025] A drug-coated balloon (DCB) 20 and at least one energy emitter 24 are coupled to the catheter body 12 adjacent the distal end thereof. As explained below, the energy emitters 24 are configured to emit energy to the lesion to enhance delivery or uptake of the active agent at the lesion treatment site as the active agent is released from the drug -coated balloon. Tn the illustrated embodiment, the energy emitters 24 are disposed inside the drug-coated balloon 20, such as being coupled directly to the catheter body 12 inside the drug-delivery balloon. In other embodiments, the energy emitters 24 may be disposed on the balloon 20, such as on the exterior of the balloon or within the balloon wall.

[0026] The drug-coated balloon 20 may be of any suitable type configured to release an active agent at a lesion treatment site to inhibit restenosis. In one example, the drug- coated balloon 20 may include an anti-proliferation agent, such as paclitaxel or sirolimus. As an example, the drug-coated balloon 20 may be constructed according to the teachings set forth in U.S. Patent No. 10,695,542, filed March 22, 2017, the relevant teachings of which relating to drug-coated balloon construction is incorporated by reference herein. The catheter body 12 defines or otherwise includes a DCB inflation lumen 26 extending along its length from adjacent a proximal end of the body to and in fluid communication with the drug-coated balloon 20. In one non-limiting example, a connector 28 (e.g., a luer- type connector) is in fluid communication with drug-coated balloon inflation lumen 26. The connector 28 is configured to fluidly connect to a fluid source (e.g., saline) for inflating / expanding the drug-coated balloon 20. A fluid mover 30 (e.g., syringe or pump) may be in fluid communication with the fluid source to deliver the inflation fluid into and through the DCB inflation lumen 26 to the drug-coated balloon 20.

[0027] In the illustrated embodiment, the energy emitters 24 are spaced apart along the catheter body 12 within the drug-coated balloon 20. The energy emitters 24 may comprise ultrasound emitters, such as ultrasonic transducers. The ultrasound transducers 24 may be powered by an external power source 31 that is disposed outside the body during the surgical procedure. One or more electrical conductors (not shown) may electrically connect the ultrasound transducer(s) 24 to the power source 31. The ultrasound transducer(s) 24 are configured to emit acoustic waves in the frequency of from about 1 MHZ to about 3 MHz. The acoustic sound waves at least one of increase local blood flow at the lesion treatment site L, increase extensibility of fibers at the lesion treatment site, and reduce viscosity of fluid. Each of which increases, promotes, and / or enhances uptake or delivery of the active agent into the lesion treatment site L as the active agent is released from the drug-coated balloon 20.

[0028] Referring to FIG. 2, in an exemplary method of treating a lesion L in a blood vessel BV, the multimodal catheter 10 is introduced into the blood vessel and tracked to the lesion treatment site along a guidewire G. At the treatment sit, the drug-coated balloon 20 is inflated to release the active agent in the lesion L. Simultaneously with the drug- coated balloon treatment, the energy emitters 24 are activated to emit energy (e.g., ultrasound) to the lesion treatment site L. The energy promotes or enhances uptake or delivery of the active agent to the lesion treatment site.

[0029] Referring to FIG. 3, another embodiment of catheter for treating a lesion in a blood vessel is generally indicated at reference numeral 110. The catheter 110 includes a catheter body 112 sized and shaped for insertion into and tracking through a selected blood vessel, such as an artery. As a non-limiting example, the catheter body 112 may have a diameter from about 1 mm to about 10 mm and a length from about 50 cm to about 150 cm. The catheter body 112 may be formed from a suitable polymer providing suitable flexibility and trackability. In a non-limiting example, the catheter body 112 may be formed from a suitable polyethylene, nylon, or blends thereof. The catheter body 112 may be formed from other materials. The catheter body 112 may define or otherwise include a guidewire lumen 114 for receiving guidewire G therein. The guidewire lumen 114 may be compatible with a suitable conventional guidewire G, such as a 0.014 in, 0.018 in, or 0.035 in guidewire. As would be understood by those in the art, the guidewire G is used to deliver the catheter body 112 to the treatment site.

[0030] The catheter 110 further includes at least one energy emitter 124 adjacent a distal end thereof. The energy emitter 124 is configured to emit electromagnetic in the light spectrum, such as near infrared energy, for absorption by the lesion to reduce inflammation and stabilize the lesion. In this embodiment, the catheter 110 is free from an angioplasty balloon or drug-coated balloon. In other embodiments, such as illustrated in FIG. 5, a catheter 210 may include an angioplasty balloon or drug-coated balloon 220 in combination with at least one energy emitter 224. In this embodiment, the energy emitter(s) 224 may be disposed in the balloon 220 (e.g., drug-coated balloon), similar to the catheter 10. Other than the inclusion of the balloon 220, the structure of the catheters 110, 210 may be similar or identical. Alternatively, as illustrated, the at least one energy emitter 224 may be photodiodes or other emitters that are powered by a power source 231.

[0031] In each catheter 110, 210, the energy emitted from the energy emitter 124, 224 is directed toward the lesion L, such as being directed in a lateral or radial direction relative to the catheter body 112, 212. It is believed the absorption of the emitted energy in the lesion promotes mitochondria activity. Tn general, atherosclerosis is a chronic inflammatory disease of the arterial wall where unstable atherosclerotic plaque rupture causing platelet aggregation and thrombosis may compromise the arterial lumen, leading to acute or chronic ischemic syndromes. Mitochondria are the main source of cellular energy. Under stress, mitochondria are also capable of controlling inflammation through the production of reactive oxygen species (ROS) and the release of mitochondrial components, such as mitochondrial DNA (mtDNA), into the cytoplasm or into the extracellular matrix, where they act as danger signals when recognized by innate immune receptors. Primary or secondary mitochondrial dysfunctions are associated with the initiation and progression of atherosclerosis by elevating the production of ROS, altering mitochondrial dynamics and energy supply, as well as promoting inflammation. ROS are important signaling molecules that activate pro-thrombotic and pro-inflammatory pathways in the endothelium, resulting in the transformation from endothelial dysfunction to the eventual development of atherosclerotic plaques.

[0032] By directing light energy to the lesion, photons are absorbed by mitochondrial chromophores. Consequently, electron transport, adenosine triphosphate (ATP) nitric oxide release, blood flow, reactive oxygen species increase and diverse signaling pathways get activated. This reduces inflammation, augments tissue repair and promotes regeneration ofdifferent tissues and nerves, and prevents tissue damage in situations where it is likely to occur.

[0033] Referring to FIG. 3, the catheter 110 includes a light source 131 (e.g., a laser) at a proximal end of the catheter body 112, a fiber optic 141 in communication with light source and extending along the catheter body to adjacent a distal end thereof, and an optical diffuser 143 at the end of the fiber optic through which the light energy is emitted from the catheter. Referring to FIG. 5, the catheter 210 includes one or more photodiodes (e.g., NIR photodiodes) positioned adjacent the distal end of the catheter body, such as in a balloon as illustrated or in an embodiment without a balloon. In each catheter 110, 210, the emitted electromagnetic radiation may have wavelengths from about 150 nm to about 1200 nm. In one example, the light emission may be in the near infrared (NIR) spectrum (650-900 nm) to penetrate into the lesion. The NIR energy will not be absorbed by hemoglobin or other body fluids, so it is believed it is well suited for lesions.

[0034] Referring to FIG. 4, in an exemplary method of treating a lesion L in a blood vessel BV, the catheter 110 is introduced into the blood vessel and tracked to the lesion treatment site along a guidewire G. At the treatment site L, the energy emitter(s) 124 are activated to emit light energy to the lesion treatment site, thereby reducing inflammation and promoting stabilization of the lesion. In one example, the lesion L treated may be a lesion that occludes less than 80% of the blood vessel, or less than 70% of the blood vessel, or less than 60% of the lesion, or less than 50% of the lesion. These lesions L are typically not candidates for stenting, and therefore, are candidates for treatment with light energy to reduce inflammation and promote stabilization of the lesion.

[0035] In an exemplary method of using the catheter 210, the light energy emitter(s) 224 may be activated simultaneously with inflation of the drug-coated balloon 220. In another example, the lesion L may be first treated with the light energy or the drug-coated balloon 220, and then subsequently treated with the other device.

[0036] Referring to FIG. 7, another embodiment of catheter for treating a lesion in a blood vessel is generally indicated at reference numeral 310. The catheter 310 includes a catheter body 312 sized and shaped for insertion into and tracking through a selected blood vessel, such as an artery. As a non-limiting example, the catheter body 312 may have a diameter from about 1 mm to about 10 mm and a length from about 50 cm to about 150 cm. The catheter body 312 may be formed from a suitable polymer providing suitableflexibility and trackability. In a non-limiting example, the catheter body 312 may be formed from a suitable polyethylene, nylon, or blends thereof. The catheter body 312 may be formed from other materials. The catheter body 312 may define or otherwise include a guidewire lumen 314 for receiving guidewire G therein. The guidewire lumen 314 may be compatible with a suitable conventional guidewire G, such as a 0.014 in, 0.018 in, or 0.035 in guidewire. As would be understood by those in the art, the guidewire G is used to deliver the catheter body 312 to the treatment site.

[0037] A drug-coated balloon (DCB) 320 and at least one energy emitter 324 are coupled to the catheter body 312 adjacent the distal end thereof. As explained below, the energy emitters 324 are configured to emit energy (i.e., electric pulse) to the lesion L to enhance delivery or uptake of the active agent at the lesion treatment site as the active agent is released from the drug-coated balloon 320.

[0038] The drug-coated balloon 320 may be of any suitable type configured to release an active agent at a lesion treatment site to inhibit restenosis. In one example, the drug- coated balloon 320 may include an anti-proliferation agent, such as paclitaxel or sirolimus. As an example, the drug-coated balloon 320 may be constructed according to the teachings set forth in U.S. Patent No. 10,695,542, filed March 22, 2017, the relevant teachings of which relating to drug-coated balloon construction is incorporated by reference herein. The catheter body 312 defines or otherwise includes a DCB inflation lumen 326 extending along its length from adjacent a proximal end of the body to and in fluid communication with the drug-coated balloon 320. In one non-limiting example, a connector 328 (e.g., a luer-type connector) is in fluid communication with drug-coated balloon inflation lumen 326. The connector 328 is configured to fluidly connect to a fluid source (e.g., saline) for inflating / expanding the drug-coated balloon 320. A fluid mover 330 (e.g., syringe or pump) may be in fluid communication with the fluid source to deliver the inflation fluid into and through the DCB inflation lumen 326 to the drug-coated balloon 320.

[0039] The energy emitter(s) 324 may comprise suitable electrodes for generating the suitable electric pulse to transiently increase permeability / porosity of the cells of the lesion and / or the vessel wall to enhance delivery of an active agent or other substance (e.g., DNA, RNA, proteins, enzymes, or other biomolecules) into the cells of the lesion and / or vessel wall. In general, the catheter is suitable for use in process called electroporation.Electroporation involves the application of brief, high-voltage electrical pulses to create temporary pores or openings in a cell membrane, allowing the entry of molecules that are normally too large or charged to pass through the membrane on their own. By creating temporary pores in the cell membrane through the application of high-voltage electrical pulses, electroporation enables the entry of molecules that are typically too large, charged, or hydrophilic to pass through the lipid bilayer unassisted. The temporary pores created by electroporation allow for a rapid and efficient uptake of the desired substances into the cells. Once inside, these molecules can interact with the cellular machinery and exert their effects.

[0040] In the illustrated embodiment, the electrodes 324 are disposed inside the drug- coated balloon 320, such as being coupled directly to the catheter body 312 inside the drug-delivery balloon. In other embodiments, the electrodes 324 may be disposed on the balloon 320, such as on the exterior of the balloon or within the balloon wall. In the illustrated embodiment, the energy emitters 324 are spaced apart along the catheter body 312 within the drug-coated balloon 320. The electrodes 324 may be powered by a power source 331 that is disposed outside the body during the surgical procedure. One or more electrical conductors (not shown) may electrically connect the electrodes 324 to the power source 331. The power source 331 may include a controller 333 (e.g., processor in combination with memory including processor-readable instructions) for controlling power (e.g., voltage) supplied to the electrodes 324 so that a suitable electric pulse is generated and transmitted to the lesion L. A battery 335, such as a battery in the power source 331 , may be used to generate voltage.

[0041] Referring to FIG. 8, in an exemplary method of treating a lesion L in a blood vessel BV, the multimodal catheter 310 is introduced into the blood vessel and tracked to the lesion treatment site along a guidewire G. At the treatment sit, the drug-coated balloon 320 is inflated to release the active agent in the lesion L. Simultaneously with the drug- coated balloon treatment, for example, power (e.g., high voltage, high frequency) is supplied to the electrodes 324 to generate an electric pulse(s) that increases the permeability / porosity of the cells of the lesion and / or blood vessel to promote and / or enhance uptake or delivery of the active agent to the lesion treatment site.

[0042] The duration of the electric pulses applied can vary depending on the specific application cell type. Generally, the duration of the electric pulses ranges frommicroseconds (μs) to milliseconds (ms). The electric pulses are typically very short and of high intensity to create the necessary electric field for pore formation. The duration of the resultant temporary pores typically last for a short period of time, typically in the range of milliseconds to minutes. The exact duration of the induced pores depends on various factors such as the cell type, pulse parameters, and the recovery properties of the cell membrane. After electroporation, the cell membrane undergoes a process of resealing, during which the temporary pores close, restoring the integrity of the membrane. The size and stability of the temporary pores can vary depending on the electroporation conditions. In some cases, the pores may be relatively stable, allowing for prolonged permeability, while in other cases, they may rapidly reseal after a brief period. The pulse duration, voltage, and number of pulses are suitable to achieve effective membrane porosity while minimizing potential tissue damage.

[0043] Referring to FIG. 9, another embodiment of catheter for treating a lesion in a blood vessel is generally indicated at reference numeral 410. This catheter 410 is similar to catheter 310 in that it includes the following similar or identical components: catheter body 412, guidewire lumen 414, drug-coated balloon 420, energy emitter(s) (e.g., electrode(s) 424), a DCB inflation lumen 426, a connector 428, a source of fluid 430, and a power supply 431 including a controller 433 and a source of power (e.g., battery) 435. Unlike catheter 310, the electrode(s) 424 of the present catheter 410 are disposed outside, generally adjacent to the drug-coated balloon 420. In particular, the electrodes 424 are coupled to the catheter body 412 outside the drug-coated balloon 420. In the illustrated embodiment, the electrodes 424 are proximal of the drug-coated balloon 420. In one or more embodiments, the electrodes may be distal of the drug-coated balloon 420. The method of using the catheter 420 may be the same as described above with respect to catheter 310, whereby, in general, an electric pulse(s) from the electrodes 424 increases the permeability / porosity of the cells of the lesion and / or blood vessel to promote and / or enhance uptake or delivery of the active agent to the lesion treatment site.

[0044] The invention may be further described by reference to the following numbered paragraphs:1. A catheter for treating a lesion treatment site in a blood vessel comprising: a catheter body having opposite proximal and distal ends and a length extending between the proximal and distal ends;a drug-coated balloon coupled to the catheter body adjacent the distal end thereof, wherein the drug-coated balloon is configured to deliver an active agent to the lesion treatment site; and an energy emitter coupled to the catheter body, wherein the energy emitter is configured to emit energy from adjacent the distal end of the catheter body to the lesion treatment site to enhance delivery or uptake of the active agent at the lesion treatment site as the active agent is released from the drug-coated balloon.2. The catheter set forth in paragraph 1 , wherein the energy emitter comprises at least one ultrasound emitter.3. The catheter set forth in paragraph 1 , wherein the energy emitter comprises a plurality of ultrasound emitters spaced apart from one another relative to the length of the catheter body.4. The catheter set forth in any one of paragraphs 1 to 3, wherein the energy emitter is configured to emit acoustic waves at frequencies from about 1 MHz to about 3 MHz.5. The catheter set forth in any one of paragraphs 1 to 4, wherein the energy emitter is received within the drug-coated balloon.6. The catheter set forth in any one of paragraphs 1 to 5, wherein the energy emitter is configured to be operated simultaneously with inflation of the drug-coated balloon.7. The catheter set forth in paragraph 2, wherein the energy emitter comprises at least one electrode configured to generate an electric pulse to induce electroporation at the lesion treatment site.8. The catheter set forth in paragraph 7, wherein the at least one electrode is disposed outside the drug-coated balloon.9. A catheter for treating a lesion treatment site in a blood vessel comprising: a catheter body having opposite proximal and distal ends and a length extending between the proximal and distal ends; and a light energy emitter coupled to the catheter body adjacent the distal end thereof, wherein the light energy emitter is configured to emit light energy to the lesion treatment site to reduce inflammation and promote stabilization of the lesion treatment site.10. The catheter set forth in paragraph 9, wherein the light energy emitter is configured to emit light energy having a wavelength from about 650 nm to about 900 nm.11. The catheter set forth in any one of paragraphs 8 or 9, further comprising an optical diffuser in communication with the light energy emitter and configured to diffuse the light energy across the lesion treatment site.12. The catheter set forth in any one of paragraphs 9 to 11, wherein the light energy emitter comprises a light energy source at the proximal end of the catheter body and an optical fiber in communication with the light energy source and extending along the length of the catheter body to the distal end of the catheter body.13. The catheter set forth in any one of paragraphs 9 or 10, wherein the light energy emitter comprises a light source adjacent the distal end of the catheter body.14. The catheter set forth in paragraph 12, wherein the light energy emitter comprises a photodiode.15. The catheter set forth in any one of paragraphs 9 to 14, further comprising a drug-coated balloon coupled to the catheter body adjacent a distal end thereof.16. The catheter set forth in paragraph 15, wherein the light energy emitter is received in the drug-coated balloon.17. A method of treating a lesion treatment site in a blood vessel comprising: inserting a catheter body of a catheter into the blood vessel, wherein a drug-coated balloon and an energy emitter are coupled to the catheter body, wherein the energy emitter is configured to emit energy from adjacent the distal end of the catheter body; positioning the drug-coated balloon and the energy emitter adjacent the lesion treatment site; inflating the drug-coated balloon so that the drug-coated balloon is in apposition with the lesion treatment site and an active agent is released from the balloon and delivered to the lesion treatment site; and activating the energy emitter to emit energy to the lesion treatment site, wherein the emitted energy is absorbed by the lesion treatment site to enhance delivery or uptake of the active agent at the lesion treatment site as the active agent is released from the drug- coated balloon.18. The method of treating a lesion treatment site set forth in paragraph 17, wherein said inflating the drug-coated balloon and activating the energy emitter occur simultaneously.19. The method of treating a lesion treatment site set forth in any one of paragraphs 17 to 18, wherein the energy emitter comprises an ultrasound emitter, said activating the ultrasound emitter comprises activating the ultrasound emitter to emit ultrasound waves toward the lesion treatment site.20. The method of treating a lesion treatment site set forth in any one of paragraphs 17 to 18, wherein the energy emitter comprises an electrode, said activating the electrode comprises supplying electric energy to the electrode to generate electric pulse toward the lesion treatment site, the electric pulse inducing electroporation.21. A method of treating a lesion treatment site in a blood vessel comprising: inserting a catheter body of a catheter into the blood vessel, wherein a light energy emitter is coupled to the catheter body, the light energy emitter configured to emit energy from adjacent the distal end of the catheter body; positioning the energy emitter adjacent the lesion treatment site; and activating the light energy emitter to emit light energy to the lesion treatment site, wherein the emitted light energy is absorbed by the lesion treatment site to reduce inflammation and promote stabilization of the lesion treatment site.22. The method of treating a lesion treatment site set forth in paragraph 21 , wherein the light energy emitter emits light energy having a wavelength from about 650 nm to about 900 nm.23. The method of treating a lesion treatment site set forth in any one of paragraphs 21 and 22, wherein a drug-coated balloon is coupled to the catheter body adjacent the distal end thereof, the method further comprising: positioning the drug-coated balloon adjacent the lesion treatment site; and inflating the drug-coated balloon so that the drug-coated balloon is in apposition with the lesion treatment site and an active agent is released from the balloon and delivered to the lesion treatment site.

[0045] It should be understood that various aspects disclosed herein may be combined in different combinations than the combinations specifically presented in the description and accompanying drawings. It should also be understood that, depending on the example, certain acts or events of any of the processes or methods described herein maybe performed in a different sequence, may be added, merged, or left out altogether (e.g., all described acts or events may not be necessary to carry out the techniques). In addition, while certain aspects of this disclosure are described as being performed by a single module or unit for purposes of clarity, it should be understood that the techniques of this disclosure may be performed by a combination of units or modules associated with, for example, a medical device.

[0046] In one or more examples, the described techniques may be implemented in hardware, software, firmware, or any combination thereof. If implemented in software, the functions may be stored as one or more instructions or code on a computer-readable medium and executed by a hardware-based processing unit. Computer-readable media may include non-transitory computer-readable media, which corresponds to a tangible medium such as data storage media (e.g., RAM, ROM, EEPROM, flash memory, or any other medium that can be used to store desired program code in the form of instructions or data structures and that can be accessed by a computer).

[0047] Instructions may be executed by one or more processors, such as one or more digital signal processors (DSPs), general purpose microprocessors, application specific integrated circuits (ASICs), field programmable logic arrays (FPGAs), or other equivalent integrated or discrete logic circuitry. Accordingly, the term “processor” as used herein may refer to any of the foregoing structure or any other physical structure suitable for implementation of the described techniques. Also, the techniques could be fully implemented in one or more circuits or logic elements.

Claims

WHAT IS CLAIMED IS:

1. A catheter (10, 210, 310, 410) for treating a lesion treatment site in a blood vessel comprising: a catheter body (12, 212, 312, 412) having opposite proximal and distal ends and a length extending between the proximal and distal ends; a drug-coated balloon (20, 220, 320, 420) coupled to the catheter body (12, 212, 312, 412) adjacent the distal end thereof, wherein the drug-coated balloon (20, 220, 320, 420) is configured to deliver an active agent to the lesion treatment site; and an energy emitter (24, 224, 324, 424) coupled to the catheter body (12, 212, 312, 412), wherein the energy emitter (24, 224, 324, 424) is configured to emit energy from adjacent the distal end of the catheter body (12, 212, 312, 412) to the lesion treatment site to enhance delivery or uptake of the active agent at the lesion treatment site as the active agent is released from the drug-coated balloon (20, 220, 320, 420).2 The catheter (10, 210) set forth in claim 1, wherein the energy emitter (24, 224) comprises at least one ultrasound emitter.

3. The catheter (10, 210) set forth in claim 1, wherein the energy emitter (24, 224) comprises a plurality of ultrasound emitters spaced apart from one another relative to the length of the catheter body (12, 212).

4. The catheter (10, 210) set forth in any one of claims 1 to 3, wherein the energy emitter (24, 224) is configured to emit acoustic waves at frequencies from about 1 MHz to about 3 MHz.

5. The catheter (10, 210) set forth in any one of claims 1 to 4, wherein the energy emitter (24, 224) is received within the drug-coated balloon (20, 220).

6. The catheter (10, 210) set forth in any one of claims 1 to 5, wherein the energy emitter (24, 224) is configured to be operated simultaneously with inflation of the drug- coated balloon (20, 220).

7. The catheter (310, 410) set forth in claim 1, wherein the energy emitter (324, 424) comprises at least one electrode configured to generate an electric pulse to induce electroporation at the lesion treatment site.

8. A catheter (110, 210) for treating a lesion treatment site in a blood vessel comprising: a catheter body (112, 212) having opposite proximal and distal ends and a length extending between the proximal and distal ends; and a light energy emitter (124, 224) coupled to the catheter body (112, 212) adjacent the distal end thereof, wherein the light energy emitter (124, 224) is configured to emit light energy to the lesion treatment site to reduce inflammation and promote stabilization of the lesion treatment site.

9. The catheter (110, 210) set forth in claim 8, wherein the light energy emitter (124, 224) is configured to emit light energy having a wavelength from about 650 nm to about 900 nm.

10. The catheter (110, 210) set forth in any one of claims 8 or 9, further comprising an optical diffuser (143) in communication with the light energy emitter (124, 224) and configured to diffuse the light energy across the lesion treatment site.

11. The catheter (110, 210) set forth in any one of claims 8 to 10, wherein the light energy emitter (124, 224) comprises a light energy source (131) at the proximal end of the catheter body (112, 212) and an optical fiber (141) in communication with the light energy source (131) and extending along the length of the catheter body (112, 212) to the distal end of the catheter body (112, 212).

12. The catheter (110, 210) set forth in any one of claims 8 or 9, wherein the light energy emitter (124, 224) comprises a light source (224) adjacent the distal end of the catheter body (112, 212).

13. The catheter (110, 210) set forth in any one of claims 8 to 12, further comprising a drug-coated balloon (220) coupled to the catheter body (112, 212) adjacent a distal end thereof.

14. The catheter (110, 210) set forth in claim 13, wherein the light energy emitter (124, 224) is received in the drug-coated balloon (220).

15. The catheter (110, 210) set forth in any one of claims 8 to 14, wherein the light energy emitter (124, 224) comprises a plurality of light energy emitters (124, 224) spaced apart from one another along the length of the catheter body (112, 212).

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