Multimodal catheter including drug-coated balloon for treating lesion in blood vessel

Abstract

A multimodal catheter (10,110,210) both pre-treats and treats a lesion in a blood vessel. The catheter includes a drug-coated balloon (20,120,220) and a pre-treatment device (24,124,224). The pre- treatment device is configured to modify the lesion treatment site before treating the lesion treatment site with the drug-coated balloon to facilitate uptake of the active agent during treatment with the drug-coated balloon.

Description

MULTIMODAL CATHETER INCLUDING DRUG-COATED BALLOONFOR TREATING LESION IN BLOOD VESSELFIELD

[0001] The present technology is generally related to a multimodal catheter including a drug-coated balloon for treating lesions in blood vessels, such as arteries.BACKGROUND

[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] Typically, before treatment using a drug-coated balloon catheter, the lesion needs to be modified or "prepped" to increase the ability of the drug to be effectively delivered to the vessel wall through the lesion. Conventionally, prepping the lesion involves using a treatment catheter that is separate from the drug-coated balloon catheter. After prepping, this treatment catheter must be removed from the blood vessel, thereafter the drug-coated balloon catheter is inserted and tracked to the lesion treatment site. In essence, this becomes a "two therapy" treatment with two different medical catheters.SUMMARY

[0005] The techniques of this disclosure generally relate to multimodal catheter including a drug-coated balloon for treating lesions in blood vessels.

[0006] In one aspect, the present disclosure provides a multimodal catheter for pretreating and treating a lesion treatment site in a blood vessel. The multimodal 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 drag-coated balloon is configured to deliver an active agent to the lesion treatment site. A pre-treatment device is coupled to the catheter body adjacent the distal end thereof and longitudinally spaced apart from the drug-coated balloon. The pre-treatment device is configured to modify the lesion treatment site before treating the lesion treatment site with the drug-coated balloon to facilitate uptake of the active agent during treatment with the drug-coated balloon.

[0007] In another aspect, the disclosure provides a method of treating a lesion in a blood vessel. The method comprises inserting a catheter body of a multimodal catheter into the blood vessel. A pre-treatment device and a drag-coated balloon are coupled to the catheter body adjacent a distal end thereof. The pre-treatment device of the multimodal catheter is positioned adjacent the lesion. The lesion is modified using the pre-treatment device. The drug-coated balloon of the multimodal catheter is positioned adjacent the lesion after said modifying the lesion. The drag-coated balloon is positioned without removing the pre-treatment device from the blood vessel. The drag-coated balloon is expanded to treat the lesion.

[0008] 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

[0009] FIG. 1 is a side elevation of an embodiment of a multimodal catheter including a drag-coated balloon and a pre-treatment device on a catheter body.

[0010] FIG. 2 is a schematic of the multimodal catheter of FIG. 1 received in a blood vessel, the pre-treatment device prepping a lesion in the blood vessel.

[0011] FIG. 3 is a schematic of the multimodal catheter of FIG. 1 received in a blood vessel, the drug-coated balloon treating the lesion.

[0012] FIG. 4 is a side elevation of another embodiment of a multimodal catheter including a drug-coated balloon and a pre-treatment device on a catheter body.

[0013] FIG. 5 is a side elevation of yet another embodiment of a multimodal catheter including a pre-treatment device and a drug-coated balloon slidable over the pre-treatment device.

[0014] FIG. 6 is a schematic of the multimodal catheter of FIG. 5 received in a blood vessel, the pre-treatment device prepping the lesion in the blood vessel.

[0015] FIG. 7 is a schematic of the multimodal catheter of FIG. 5 received in a blood vessel, the drug-coated balloon treating the lesion.DETAILED DESCRIPTION

[0016] The present disclosure describes a multimodal catheter and method for treating a lesion in a blood vessel. Conventionally, a lesion in a blood vessel is first modified or "prepped" with a medical device (e.g., a catheter) before treating it with a drug-coated balloon (DCB). After prepping, the medical device is removed from the blood vessel and replaced with the drug-coated balloon catheter in a process called an exchange. This exchange process may be cumbersome and time consuming, and can lead to complications if not performed correctly. Embodiments described herein are advantageous over this process and use of separate catheters for prepping and drug delivery. In particular, the disclosed embodiments do not require catheter exchange during the procedure, enabling a less cumbersome and less time consuming medical procedure with a lower probability of complications as compared to a procedure with an exchange.

[0017] Referring to FIG. 1, a multimodal catheter for treating lesions in blood vessels 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. Thecatheter body 12 may define or otherwise include a guidewire lumen 14 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.

[0018] A drug-coated balloon (DCB) 20 and a pre-treatment device 24 are coupled to the catheter body 12 adjacent the distal end thereof. The pre-treatment device 24 and the drug-coated balloon 20 are spaced apart from one another along the length of the catheter body 12. In the illustrated embodiment, the drug-coated balloon 20 is distal of the pretreatment device 24, although in other embodiments, the drug-coated balloon may be proximal of the pre-treatment device.

[0019] The drag-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 drag-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 drag-coated balloon 20. In one non-limiting example, a connector 28 (e.g., a luer- type connector) is in fluid communication with drag-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.

[0020] The pre-treatment device 24 is suitable for modifying or "prepping" a lesion before treating the lesion with the drug-coated balloon 20 to facilitate delivery or uptake of the active agent from the drug-coated balloon. In the illustrated embodiment, the pretreatment device 24 comprises a scoring or cutting balloon. As is known in the art, the scoring balloon 24 includes an expandable balloon body 32 and scoring elements 34 on the body. As examples, the scoring elements 34 may be metal wires, blades, fins or other structures. When the balloon body 32 is expanded at the lesion L, such as shown in FIG. 2,the scoring elements 34 form incisions or cuts in the lesion, which weakens hardened plaque, for example, allowing increased uptake of the active agent from the drug-coated balloon 24, The pre-treatment device 24 may be of other types for modifying or prepping the lesion before treatment using the drug-coated balloon 20. As examples, the pretreatment device may include an atherectomy tissue-removing device (e.g., a tissue cutter such as used in directional atherectomy or a burr used in rotational atherectomy), an ablation device (e.g., a laser or other energy emitting device), and / or an angioplasty balloon.

[0021] Referring to FIG. 1, in the illustrated embodiment, the catheter body 12 defines or otherwise includes a pre-treatment inflation lumen 38 extending along its length from adjacent a proximal end of the body to and in fluid communication with the scoring balloon 24. In one non-limiting example, a connector 42 (e.g., a luer-type connector) is in fluid communication with pre-treatment inflation lumen 38. The connector 42 is configured to fluidly connect to a fluid source (e.g., saline) for inflation'expanding the scoring balloon 24. A fluid mover 44 (e.g., syringe or pump) may be in fluid communication with the fluid source to deliver the inflation fluid into and through the pretreatment inflation lumen 38 to the scoring balloon 24.

[0022] Referring to FIGS. 2 and 3, the multimodal catheter 10 is suitable for use in a method of prepping a lesion L and thereafter treating the prepped lesion using a drug- coated balloon, without the need for catheter exchange. The catheter body 12 is inserted into a blood vessel BV and delivered to a lesion L, such as by tracking the catheter body along a guidewire G. As shown in FIG. 2, the pre-treatment device (e.g., scoring balloon 24) is positioned adjacent the lesion L. In the illustrated embodiment, the scoring balloon 24 is inflated or expanded to contact the lesion L, thereby making incisions in the lesion.

[0023] Referring to FIG. 3, after prepping, the scoring balloon 24 may be deflated and the catheter body 12 is moved slightly along the guidewire G (i.e., moved proximally in the blood vessel BV) so that the non-inflated drug-coated balloon 20 is adjacent the prepped lesion L. The drug-coated balloon 20 is then inflated, thereby treating the prepped lesion L with the active agent on the drug-coated balloon. The active agent may be an antiproliferative or anti-restenotic agent, such as paclitaxel or sirolimus. After treatment, the procedure is complete and catheter body 12 can be removed from the blood vessel BV.

[0024] Referring to FIG. 4, another embodiment of a multimodal catheter is generally indicated at reference numeral 110. This catheter 110 is similar to catheter 10 in that it generally includes a catheter body 112, and a drug-coated balloon 120 adjacent a distal end of the catheter body. The drug-coated balloon 120 is inflatable by injecting a fluid (e.g., saline) through a lumen (not shown) to the balloon, such as by connecting a syringe 130 to a connector 128. These components may be similar or identical to the corresponding component described above, whereby the above teachings apply to corresponding components.

[0025] The catheter 1 10 includes a pre-treatment device 124 comprising an energy emitter configured to modify a lesion before treatment with the drug-coated balloon 120. In this illustrated embodiment, the energy emitter 124 is an ultrasound emitter configured to emit ultrasound waves in the direction of the lesion. The illustrated ultrasound emitter 124 is distal of the drug-coated balloon 120, although it may be proximal of the dmg- coated-balloon in other embodiments. A power source 131 is electrically connected to the ultrasound emitter 124 for generating the ultrasound waves at the emitter. It is understood that the energy emitter 124 may be configured to generate other types of energy for modifying the lesion, including electromagnetic radiation (e.g., ultraviolet energy, infrared energy, radiofrequency energy, and / or microwave energy).

[0026] The method of using the catheter 1 10 similar to the method described above with respect to catheter 10, except that the ultrasound emitter 124 is operated to prep the lesion before treating with the drug-coated balloon 120. After prepping, the catheter body 112 is moved distally along the guidewire G so that the drug-coated balloon 120 is adjacent the prepped lesion. The drug-coated balloon 120 is then inflated to treat the lesion.

[0027] Referring to FIG. 5, another embodiment of a multimodal catheter is generally indicated at reference numeral 210. The catheter 210 includes a catheter body 212 and a pre-treatment device 224 coupled to the body adjacent a distal end thereof. In the illustrated embodiment, the pre-treatment device 224 includes an expandable balloon that is not drug coated. The catheter body 212 defines or includes a guidewire lumen 214 and a pre-treatment inflation lumen 238 extending along a length of the catheter body. A connector 242 at a proximal end of the catheter body 212 is couplable to a source ofpressurized fluid (e.g., saline) and a fluid mover 244 (e.g., a syringe) for inflating the pretreatment balloon 224.

[0028] A drug-coated balloon 220 is slidably received on the catheter body 212 and is configured to slide axially along the catheter body from a proximal position from the pretreatment device (FIGS. 5 and 6) spaced to a distal position in which the drag-coated balloon is disposed over the pre-treatment device 224 (FIG. 7). In the illustrated embodiment, the drug-coated balloon 220 is coupled to a slidable sleeve 227 that is disposed over the catheter body 212. The slidable sleeve 227 is slidable axially along the catheter body 212, such as by using an actuator 229 or other device positioned outside the patient during use. The sleeve 227 may define or otherwise include a DCB inflation lumen 226 (FIG. 5) in fluid communication with the drug-coated balloon 220. A connector 228 enables a source of fluid and' or a fluid mover 230 to the coupled thereto for delivering fluid (e.g., saline) to inflate the drag-coated balloon. In another embodiment, the drug- coated balloon may not be independently inflatable, but instead, the pre-treatment balloon may expand the drug-coated balloon when it is disposed within the drug-coated balloon.

[0029] Referring to FIG. 6, in use the pre-treatment device (e.g., balloon) 224 is first positioned adjacent the lesion L in the blood vessel BV. The pre-treatment device 224 is operated (e.g., inflated) to prep or modify the lesion L. Referring to FIG. 7, while maintaining the pre-treatment device 224 at the lesion L, the drag-coated balloon 220 is slid over the pre-treatment device so that it is adjacent the lesion. Where the pre-treatment device 224 is a pre-treatment balloon, it is first deflated before the drug-coated balloon 220 is slid over it. As can be seen in FIGS. 6 and 7, each of the pre-treatment device and the drag-coated balloon include markers 155, 157, respectively (e.g., radiopaque markers) to enable the user to locate the pre-treatment device and the drag-coated balloon under fluoroscopy, for example. As can be seen in FIG. 7, the drag-coated balloon 220 can be advanced (e.g., distally) over the pre-treatment device 224, while maintaining the pretreatment device in position relative to the lesion L, to align the marker(s) 157 on the drug- coated balloon 220 with the marker(s) 155 on the pre-treatment device 224. This allows the user to properly position the drug-coated balloon 220 relative to the prepped lesion L at the location of the pre-treatment. After positioning the drag-coated balloon 220 at the lesion treatment site L, the drag-coated balloon can be inflated via the inflation lumen 226or the pre-treatment balloon 224 can be inflated inside the drug-coated balloon, thereby expanding the drug-coated balloon in apposition with the lesion L.

[0030] As can be understood, the use of the disclosed embodiments of the multimodal catheter for treating a lesion in a blood vessel, as compared to the conventional use of two separated catheters that need to be exchanged, has one or more of the following advantages, among others: faster procedures; less likelihood of injury to blood vessel due to less tracking in and out of blood vessel: and better ability to align the drug-coated balloon with the prepped lesion.

[0031] The invention may be further described by reference to the following numbered paragraphs:1. A multimodal catheter for pre-treating and 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 a pre-treatment device coupled to the catheter body adjacent the distal end thereof and longitudinally spaced apart from the drug-coated balloon, wherein the pretreatment device is configured to modify the lesion treatment site before treating the lesion treatment site with the drug-coated balloon to facilitate uptake of the active agent during treatment with the drug-coated balloon.2. The multimodal catheter set forth in paragraph 1, wherein the pre-treatment device comprises an inflatable balloon.3. The multimodal catheter set forth in any one of paragraphs 1 or 2, wherein the pre-treatment device comprises a scoring balloon.4. The multimodal catheter set forth in paragraph 1, wherein the pre-treatment device comprises an energy emitter.5. The multimodal catheter set forth in paragraph 4, wherein the pre-treatment device comprises an ultrasound emitter.6. The multimodal catheter set forth in any one of paragraphs 1 to 5, wherein the drug-coated balloon is distal of the pre-treatment device.7. The multimodal catheter set forth in any one of paragraphs 1 to 5, wherein the drug-coated balloon is proximal of the pre-treatment device.8. The multimodal catheter set forth in any one of paragraphs 1 to 7, wherein the drug-coated balloon is selectively slidable along the catheter body and over the pretreatment device.9. The multimodal catheter set forth in paragraph 8, further comprising a sleeve coupled to the drug-coated balloon and selectively slidable along the catheter body to impart axial sliding of the drug-coated balloon on the catheter body.10. The multimodal catheter set forth in any one of paragraphs 8 or 9, wherein each of the drug-coated balloon and the pre-treatment device includes a radiopaque marker that is alignable with the other radiopaque marker when the drug-coated balloon is received over the pre-treatment device.11. The multimodal catheter set forth in any one of paragraphs 8 to 10, wherein the pre-treatment device comprises an inflatable pre-treatment balloon configured to expand the drug-coated balloon when the drug-coated balloon is received over the pre-treatment balloon.12. A method of treating a lesion in a blood vessel comprising: inserting a catheter body of a multimodal catheter into the blood vessel, wherein a pre-treatment device and a drug-coated balloon are coupled to the catheter body adjacent a distal end thereof; positioning the pre-treatment device of the multimodal catheter adjacent the lesion; modifying the lesion using the pre-treatment device; positioning the drug-coated balloon of the multimodal catheter adjacent the lesion after said modifying the lesion, wherein the drug-coated balloon is positioned without removing the pre-treatment device from the blood vessel; and expanding the drug-coated balloon to treat the lesion.13. The method of treating a lesion in a blood vessel set forth in paragraph 12, wherein the pre-treatment device is a balloon, wherein said modifying the lesion comprises inflating the balloon in apposition with the lesion.14. The method of treating a lesion in a blood vessel set forth in paragraph 13, wherein the pre-treatment balloon is a scoring balloon.15. The method of treating a lesion in a blood vessel set forth in paragraph 12, wherein the pre-treatment device comprises an energy emitter, wherein said modifying the lesion comprises emitting energy from the energy emitter toward the lesion.16. The method of treating a lesion in a blood vessel set forth in paragraph 12, wherein the pre-treatment device comprises an ultrasound emitter., wherein said modifying the lesion comprises emitting ultrasound from the ultrasound emitter toward the lesion.17. The method of treating a lesion in a blood vessel set forth in any one of paragraphs 12 to 16, wherein said positioning a drug-coated balloon comprises sliding the drug-coated balloon over the pre-treatment device.18. The method of treating a lesion in a blood vessel set forth in paragraph 17, wherein said expanding the drag-coated balloon comprises expanding the pre-treatment device after said sliding the drag-coated balloon over the pre-treatment device.19. The method of treating a lesion in a blood vessel set forth in paragraph 17, wherein said expanding the drag-coated balloon comprises inflating the drug-coated balloon with inflation fluid.20. The method of treating a lesion in a blood vessel set forth in any one of paragraphs 17 to 19, wherein said positioning a drug-coated balloon comprises aligning at least one marker associated with the drug-coated balloon with at least one marker associated with the pre-treatment device.

[0032] 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 may be 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.

[0033] In one or more examples, the described techniques may be implemented in hardware, software, firmware, or any combination thereof. If implemented in software, thefunctions 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).

[0034] 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 multimodal catheter (10, 110, 210) for pre-treating and treating a lesion treatment site in a blood vessel comprising: a catheter body (12, 112, 212) having opposite proximal and distal ends and a length extending between the proximal and distal ends; a drug-coated balloon (20, 120, 220) coupled to the catheter body (12, 112, 212) adjacent the distal end thereof, wherein the drug-coated balloon (20, 120, 220) is configured to deliver an active agent to the lesion treatment site; and a pre-treatment device (24, 124, 224) coupled to the catheter body (12, 112, 212) adjacent the distal end thereof and longitudinally spaced apart from the drug-coated balloon (20, 120, 220), wherein the pre-treatment device (24, 124, 224) is configured to modify the lesion treatment site before treating the lesion treatment site with the drug- coated balloon (20, 120, 220) to facilitate uptake of the active agent during treatment with the drug-coated balloon (20, 120, 220).

2. The multimodal catheter (10, 110, 210) set forth in claim 1 , wherein the pretreatment device (24, 124, 224) comprises an inflatable balloon (24, 224).

3. The multimodal catheter (10, 110, 210) set forth in any one of claims 1 or 2, wherein the pre-treatment device (24, 124, 224) comprises a scoring balloon (24).

4. The multimodal catheter (10, 110, 210) set forth in claim 1, wherein the pretreatment device (24, 124, 224) comprises an energy emitter (124).

5. The multimodal catheter (10, 110, 210) set forth in claim 4, wherein the pretreatment device (24, 124, 224) comprises an ultrasound emitter (24).

6. The multimodal catheter (10, 1 10, 210) set forth in any one of claims 1 to 5, wherein the drug-coated balloon (20, 120, 220) is distal of the pre-treatment device (24, 124, 224).

7. The multimodal catheter (10, 110, 210) set forth in any one of claims 1 to 5, wherein the drug-coated balloon (20, 120, 220) is proximal of the pre-treatment device (24, 124, 224).

8. The multimodal catheter (10, 1 10, 210) set forth in any one of claims 1 to 7, wherein the drug-coated balloon (220) is selectively slidable along the catheter body (212) and over the pre-treatment device (224).

9. The multimodal catheter (10, 110, 210) set forth in claim 8, further comprising a sleeve (227) coupled to the drug-coated balloon (220) and selectively slidable along the catheter body (212) to impart axial sliding of the drug-coated balloon (220) on the catheter body (212).

10. The multimodal catheter (10, 1 10, 210) set forth in any one of claims 8 or 9, wherein each of the drug-coated balloon (220) and the pre-treatment device (224) includes a radiopaque marker (155, 157) that is alignable with the other radiopaque marker (155, 157) when the drug-coated balloon (220) is received over the pre-treatment device (224).11 . The multimodal catheter (10, 110, 210) set forth in any one of claims 8 to 10, wherein the pre-treatment device (224) comprises an inflatable pre-treatment balloon (224) configured to expand the drug-coated balloon (220) when the drug-coated balloon (220) is received over the pre-treatment balloon (224).

12. The multimodal catheter (10, 110, 210) set forth in any one of claims 8 to 1 1 , wherein the drug-coated balloon (20, 120, 220) is independently inflatable.

13. The multimodal catheter (10, 110, 210) set forth in claim 9, wherein the sleeve (227) defines or includes an inflation lumen (226) in communication with the drug-coated balloon (220) and configured to deliver fluid to the drug-coated balloon (220) to inflate the drug-coated balloon (220).

14. The multimodal catheter (10, 110, 210) set forth in any one of claims 1 to 13, wherein the catheter body (12, 112, 212) defines or includes a guidewire lumen (14, 214) configured to receive a guidewire therein.

15. The multimodal catheter (10, 1 10, 210) set forth in any one of claims 1 to 14, wherein the drug-coated balloon (20, 120, 220) includes an anti-proliferative active agent

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