Local drug delivery to lesion treatment site in blood vessel

Abstract

A local drug-delivery catheter (10, 110, 210) delivers an active agent to a lesion treatment site in a blood vessel without the use of a drug-coated balloon. The catheter includes a drug-delivery lumen (14) with an open distal end adjacent a distal end of a catheter body (12). An active agent solution, such as an anti-proliferative agent, is delivered through the lumen to the lesion treatment site. The catheter may include distal and / or proximal occlusion balloons (130, 230, 240) that are not drug-coated balloons to at least partially capture or retain the delivered active agent solution at the lesion treatment site. The catheter may include one or more energy emitters (250) that emit energy toward the lesion treatment site to enhance or facilitate uptake of the active agent.

Description

LOCAL DRUG DELIVERY TO LESION TREATMENT SITEIN BLOOD VESSELFIELD

[0001] The present technology is generally related to local drug delivery to a lesion treatment site in a blood vessel without the use of a drug-coated balloon.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. DCBs 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] The following description of embodiments of the invention addresses challenges and potential issues with the use of DCBs, as discovered and / or recognized by the inventors of the present application.SUMMARY

[0005] The techniques of this disclosure generally relate to local drug delivery to a lesion treatment site in a blood vessel without the use of a drug-coated balloon.

[0006] In one aspect, the present disclosure provides a local drug-delivery catheter for delivering an active agent to a lesion treatment site in a blood vessel. The cathetercomprises a catheter body having opposite proximal and distal ends and a length extending between the proximal and distal ends. The catheter body has a drug-delivery lumen extending along the length of the catheter body. The drug-delivery lumen has an open proximal end at or adjacent the proximal end of the catheter body, and an open distal end at or adjacent the distal end of the catheter body. A source of active agent solution is fluidly connected to the open proximal end of the drug-delivery lumen. The source of active agent solution includes an active agent solution. A fluid mover is in fluid communication with the source of active agent solution. The fluid mover is configured to deliver the active agent solution into and through the drug-delivery lumen via force exerted on the active agent solution. The active agent solution flows through the open distal end of the drug-delivery lumen and is delivered into the blood vessel at the lesion treatment site. The local drug-delivery catheter is free from a drug-coated balloon.

[0007] In another aspect, the disclosure provides a local drug-delivery catheter for delivering an active agent to 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. The catheter body defines a drug-delivery lumen extending along the length of the catheter body. The drug-delivery lumen has an open proximal end at or adjacent the proximal end of the catheter body, and an open distal end at or adjacent the distal end of the catheter body. A distal occlusion balloon is adjacent the distal end of the catheter body and distal of the open distal end of the drug-delivery lumen. The distal occlusion balloon is configured to be expanded to be in apposition with a wall of the blood vessel at a location distal of the lesion treatment site to inhibit delivered active agent solution from flowing passed the distal occlusion balloon. The distal occlusion balloon is not a drug-coated balloon.

[0008] In yet another aspect, the disclosure provides a method of locally delivering a drug to a lesion treatment site having a lesion in a blood vessel without the use of a drug- coated balloon. The method comprises tracking a catheter to the lesion treatment site in a blood vessel such that a distal end of the catheter is adjacent the lesion treatment site. The catheter is free from a drug-coated balloon. An active agent solution is delivered from outside the blood vessel into a drug-delivery lumen of the catheter. The active agent solution flows distally through the drug-delivery lumen and enters the blood vesselthrough a distal open end of the drug-delivery lumen at or adjacent the distal end of the catheter, whereby the active agent solution is directed toward the lesion treatment site.

[0009] 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

[0010] FIG. 1 is a schematic of an embodiment of a local drug-delivery catheter having a drug-delivery lumen.

[0011] FIG. 2 is a schematic of a distal end of the local drug-delivery catheter of FIG. 1 treating a lesion treatment site in a blood vessel.

[0012] FIG. 3 is a schematic of another embodiment a local drug-delivery catheter having a drug-delivery lumen similar to the embodiment in FIG. 1, further including a distal occlusion balloon.

[0013] FIG. 4 is a schematic of a distal end of the local drug-delivery catheter of FIG. 3 treating a lesion treatment site in a blood vessel.

[0014] FIG. 5 is schematic of another embodiment a local drug-delivery catheter having a drug-delivery lumen similar to the embodiment in FIG. 3, further including a proximal occlusion balloon and one or more energy emitters.

[0015] FIG. 6 is a schematic of a distal end of the local drug-delivery catheter of FIG. 5 treating a lesion treatment site in a blood vessel.DETAILED DESCRIPTION

[0016] The present disclosure describes a medical catheter and method for local drug delivery to a lesion treatment site in a blood vessel (e.g., artery) without the use of a drug- coated balloon (DCB). It has been discovered / recognized by the inventors of the present application that DCBs may present certain challenges in the treatment of lesions. For instance, a conventional DCB may be wrapped to forms folds to facilitate tracking through the blood vessel to the lesion treatment site. The folds are intended to inhibit a certain percentage (e.g., 66%) of the drug on the balloon from contacting the vessel wall, thereby reducing drug loss during tracking. Even with folding, at least some drug loss may occurduring tracking, which leads to a reduced amount of drug that is capable of being delivered to the blood vessel wall during expansion of the DCB. The following embodiments are intended to address shortcomings of using DCBs to deliver drugs to the treatment site.

[0017] Referring to FIGS. 1 and 2, an illustrated embodiment of a drug-delivery catheter for local delivery of a drug (i.e., active agent) to a lesion treatment site of a blood vessel without the use of a DCB 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 non-limiting examples, 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.

[0018] The catheter body 12 defines or includes one or more drug-delivery lumens 14 extending along its length from adjacent a proximal end to adjacent a distal end. The drug- delivery lumen 14 is configured to enable delivery of an active agent solution from outside the patient's body to the lesion treatment site within the blood vessel. As used herein, the term "active agent solution" only means an active agent that is in a liquid to enable the active agent to flow through the drug-delivery lumen 14; it may include, for example, chemical solutions, mixtures, suspensions, and the like. The active agent may be an anti- proliferative or anti-restenotic agent, such as paclitaxel or sirolimus. The liquid may include saline, water, alcohol, or other liquids, and combination thereof. In one non- limiting example, a connector 16 (e.g., a luer-type connector) is in fluid communication with the proximal end the drug-delivery lumen 14. The connector 16 is configured to fluidly connect to a source of active agent solution. The source of active agent solution is operatively connected to or otherwise forms part of a fluid mover 18 (e.g., syringe or pump) to deliver the active agent solution into and through the drug-delivery lumen 14 via force exerted on the active agent solution.

[0019] The active agent solution exits the drug-delivery lumen 14 to the treatment site through an open distal end or orifice 20 of the lumen. In the illustrated embodiment shown in FIGS. 1 and 2, the open distal end 20 of the drug-deliver lumen 14 extends through thedistal end of the catheter body 12 and may be offset from the longitudinal axis of the catheter body 12. In other embodiments, the open distal end 20 may be co-axial with a longitudinal axis of the catheter body 12. In yet other embodiments, the open distal end 20 of the drug-delivery lumen 14 may be spaced from the distal end of the catheter body 12 and extend through a side wall of the catheter body in a transverse direction relative to the longitudinal axis of the body. Such an example is shown in FIGS. 3-6.

[0020] In the illustrated embodiment, the catheter body 12 further defines or includes a guidewire lumen 22 configured to receive a guidewire G therein. The guidewire lumen 22 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.

[0021] In one example, the catheter body 12 may be part of or form the catheter body of another treatment device suitable for "prepping” or modifying the lesion before delivering the active agent to the lesion treatment site. As examples, the catheter body 12 may be part of or form the catheter body of an angioplasty balloon catheter (i.e., not a DCB catheter) or an atherectomy catheter.

[0022] Referring to FIG. 2, the catheter 10 is suitable for use in a method of locally delivering a drug to a lesion treatment site L in a blood vessel BV without the use of a DCB. In a suitable example, the blood vessel lesion L is "prepped" or modified using a suitable device (not shown) that may be typically used before conventional treatment with a DCB catheter to facilitate drug uptake into the vessel wall. For example, an atherectomy device, angioplasty balloon, scoring balloon, intravascular lithotripsy treatment (e.g., acoustic wave therapy), and / or laser treatment, among others, may be used to prep or modify the lesion L beforehand. After prepping, in one example, the prepping device is withdrawn from the blood vessel BV and then the catheter body 12 is tracked along the blood vessel to the lesion treatment site. In one example, the same guidewire G used in the prepping procedure may be used to track the catheter body 12 to the lesion treatment site. In the example where the catheter body 12 is part of the prepping device, it is not necessary to withdrawal the device.

[0023] With the catheter body 12 suitable positioned at the lesion treatment site L, such as being positioned proximal to the treatment site as illustrated, the active agent solution is delivered through the drug-delivery lumen 14 and to the prepped lesion. Theprepped lesion may be "bathed" in the active agent solution to enable the blood vessel wall at the lesion L to take up the active agent. The catheter body 12 may be moved along the lesion L during delivery of the active agent solution to facilitate uptake along the length of the lesion. In one or more examples, the active agent solution includes an active agent in a liquid. The active agent may be an anti-proliferative or anti-restenotic agent, such as paclitaxel or sirolimus. The liquid may include saline, water, alcohol, or other liquids, and combination thereof.

[0024] Referring to FIGS. 3 and 4, another illustrated embodiment of a drug-delivery catheter for local delivery of a drug (i.e., active agent) to a treatment site of a blood vessel without the use of a DCB is generally indicated at reference numeral 110. This embodiment is similar to the catheter 10 in that it includes a catheter body 112 defining a drug-delivery lumen 114 with one or more open distal ends or orifices 120 for delivering the active agent solution to the lesion treatment site, a guidewire lumen 122 for a guidewire G, and a connector 116 for connecting the source of active agent solution to the drug-delivery lumen, and a fluid mover 118 for delivering the active agent solution into and through the drug-delivery lumen. These components may be similar or identical to the corresponding component described above, whereby the above teachings apply to corresponding components.

[0025] This catheter 110, unlike catheter 10, also includes a distal occlusion balloon 130 adjacent the distal end of the catheter body 112. The open distal end(s) 120 of the drug-delivery lumen(s) 114 are at a sidewall of the catheter body 112, proximal of the distal occlusion balloon 130. As shown in FIG. 3, the distal occlusion balloon 130 is configured to inflate or expand to be in apposition with the blood vessel wall to inhibit the active agent solution from traveling distally past the balloon within the blood vessel. In this way, the delivered active agent solution is more likely to concentrate at the lesion treatment site L to allow suitable "bathing" of the site. The distal occlusion balloon 130 is a non-DCB. The balloon 130 has a suitable expanded diameter and compliance to enable it to be in suitable apposition with the wall of the blood vessel BV. The catheter body 112 may define or otherwise include an inflation lumen 132 (FIG. 3) for inflating and deflating the balloon 130. Saline or other suitable fluid may be delivered through the inflation lumen 132 to inflate the balloon 130, such as by using a syringe 131 or other device.

[0026] The illustrated catheter 110 also enables the delivered active agent solution to be withdrawn or sucked back into the catheter body after treatment and before deflating the balloon 130 and withdrawing the catheter body 112. In one example, the fluid mover 118 may be configured to function as both a high pressure device for delivering the active agent solution, and a low pressure device for sucking the delivered active agent solution from the lesion treatment site back into the drug-delivery lumen 114. In another embodiment, a separate low pressure device may be used. In yet another embodiment, the catheter body 112 may define or otherwise include a separate aspiration lumen for withdrawing the active agent solution from the treatment site.

[0027] Referring to FIGS. 5 and 6, another catheter similar to catheter 110 is generally indicated at reference numeral 210. Like catheter 110, this catheter 210 includes a catheter body 212 defining a drug-delivery lumen 214 having one or more distal open ends 220 for delivering the active agent solution to the lesion treatment site, a guidewire lumen 222 for a guidewire G, a connector 216 for connecting the source of active agent solution to the drug-delivery lumen, a fluid mover 218 for delivering the active agent solution into and through the drug-delivery lumen, a distal occlusion balloon 230, and an inflation lumen 232. These components may be similar or identical to the corresponding component described above, whereby the above teachings apply to corresponding components.

[0028] This catheter 210, unlike catheter 110, also includes a proximal occlusion balloon 240 spaced longitudinally from the distal occlusion balloon 230. The open distal end(s) 220 of the drug-delivery lumen 214 is disposed between the proximal and distal occlusion balloons 240, 230. The proximal occlusion balloon 240 may be similar or identical to the distal occlusion balloon 230. Like the distal occlusion balloon 230, the proximal occlusion balloon 240 is configured to inflate or expand in apposition with the wall of the blood vessel BV to inhibit the active agent solution from traveling proximally past the balloon within the blood vessel BV. The proximal balloon 240 in combination with the distal balloon 230 captures the active agent solution therebetween, whereby the delivered active agent solution is more likely to concentrate at the lesion treatment site L to allow suitable "bathing" of the lesion. The proximal occlusion balloon 240 is a non- DCB. The balloon 240 has a suitable expanded diameter and compliance to be enable it to be in suitable apposition with the blood vessel wall. The catheter body 212 may define or otherwise include an inflation lumen for inflating and deflating the balloon 240. This maybe the same inflation lumen 232 or a different lumen in communication with the distal occlusion balloon 230.

[0029] The catheter 210 further includes one or more energy emitters 250 configured to be selectively activated to enhance delivery and uptake of the active agent at the treatment site. It is understood that any of the disclosed embodiments may include the energy emitter. It is also understood that the catheter 210 may not include the energy emitter in another embodiment.

[0030] In the illustrated embodiment, the energy emitter(s) 250 is coupled to the catheter body 212, either within the catheter body or on the exterior of the body, between the proximal and distal occlusion balloons 240, 230. In one example, the energy emitter 250 may include one or more ultrasound transducers. The transducer(s) may be electrically powered by a power source 252 at the proximal end of the catheter 210. An electrical conductor 254 may electrically connect the power source 252 to the emitter(s) 250. The transducer(s) 250 may be selectively activated during or after delivery of the active agent solution at the lesion treatment site L. The transducer(s) 250 may emit ultrasonic waves at a frequency of about 1 MHz to about 5 MHz, and are suitable for enhancing delivery and uptake of the active agent in the blood vessel wall at the treatment site L. The energy emitter(s) 250 may be other types of emitters for emitting other types of energy. In other examples, the energy emitter 250 may be a radiofrequency emitter, a pulse field emitter suitable for electroporation, or other types of energy emitters.

[0031] As with the catheter 110, the illustrated catheter 210 also enables the delivered active agent solution to be withdrawn or sucked back into the catheter body after treatment and before deflating the balloons 230, 240 and withdrawing the catheter body 212, as described above.

[0032] Referring to FIGS 4 and 6, each catheter 110, 210 is suitable for use in a method of locally delivering a drug to a treatment site in a blood vessel BV without the use of a DCB. In a suitable example, a lesion L within a blood vessel BV is "prepped" or modified using a suitable device that may be typically used before conventional treatment with a DCB catheter to facilitate drug uptake into the vessel wall. For example, an atherectomy device, angioplasty balloon, scoring balloon, intravascular lithotripsy treatment (e.g., acoustic wave therapy), and / or laser treatment, among others, may be used to prep or modify the lesion beforehand. After prepping, in one example, the preppingdevice is withdrawn from the blood vessel and the catheter body 112, 212 is tracked along the blood vessel to the treatment site at the location of the prepped lesion. In one example, the same guidewire G used in the prepping procedure may be used to track the catheter body 112, 212 to the treatment site L. In the example where the catheter body 112, 212 is part of the prepping device, it is not necessary to withdrawal the device and insert the catheter body.

[0033] With the catheter body 112, 212 suitably positioned at the treatment site L, the distal occlusion balloon 230 is inflated to be in apposition with the blood vessel wall distal of the lesion L, and when using the catheter 212, the proximal occlusion balloon 240 is also inflated to be in apposition with the blood vessel wall proximal of the lesion. The active agent solution is then delivered through the drug-delivery lumen 114, 214 and to the prepped lesion. The prepped lesion may be "bathed" in the active agent solution to enable the wall of the blood vessel BV at the lesion L to take up the active agent. The distal balloon 230 inhibits the active agent solution from flowing distally beyond the balloon. The proximal balloon 240 inhibits the active agent from flowing proximally, thereby capturing the solution at the lesion treatment site L. In one or more examples, the active agent solution includes an active agent in a liquid. The active agent may be an anti- proliferative or anti-restenotic agent, such as paclitaxel or sirolimus. The liquid may include saline, water, alcohol, or other liquids, and combination thereof.

[0034] When using the catheter 210, the energy emitter(s) 250 are activated before, during, and / or after delivering the active agent solution to the treatment site L. The energy emitter(s) 250 enhance or facilitate the uptake of the active agent into the blood vessel wall. Where the emitters) 250 are ultrasound transducers or other ultrasonic emitters, the frequency of the acoustic waves may be from about 1MHz to about 5 MHz. The emitter(s) may be activated for a predetermined or set period of time, and may be controlled using a programmable processor executing instructions stored on a processor-readable medium.

[0035] The invention may be further described by reference to the following numbered paragraphs:1. A local drug-delivery catheter for delivering an active agent to 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, the catheter body having a drug-deliverylumen extending along the length of the catheter body, wherein the drug-delivery lumen has an open proximal end at or adjacent the proximal end of the catheter body, and an open distal end at or adjacent the distal end of the catheter body; a source of active agent solution fluidly connected to the open proximal end of the drug-delivery lumen, the source of active agent solution including an active agent solution; a fluid mover in fluid communication with the source of active agent solution, the fluid mover configured to deliver the active agent solution into and through the drug- delivery lumen via force exerted on the active agent solution, whereby the active agent solution flows through the open distal end of the drug-delivery lumen and is delivered into the blood vessel at the lesion treatment site, wherein the local drug-delivery catheter is free from a drug-coated balloon.2. The local drug-delivery catheter set forth in paragraph 1, wherein the open distal end of the drug-delivery lumen extends through the distal end of the catheter body.3. The local drug-delivery catheter set forth in paragraph 1 , wherein the open distal end of the drug-delivery lumen extends through a side wall of the catheter body adjacent the distal end thereof.4. The local drug-delivery catheter set forth in paragraph 3, wherein the open distal end of the drug-delivery lumen includes a plurality of open distal ends spaced apart from one another along the length of the catheter body adjacent the distal end thereof.5. The local drug-delivery catheter set forth in any one of paragraphs 1 to 4, wherein the fluid mover includes a positive displacement pump.6. The local drug-delivery catheter set forth in any one of paragraphs 1 to 5, further comprising an aspirator in fluid communication with the drug-delivery lumen and configured to withdraw the active-agent solution that has been delivered into the blood vessel at the lesion treatment site back through the drug-delivery lumen.7. The local drug-delivery catheter set forth in paragraph 6, wherein the fluid mover is configured as the aspirator.8. The local drug-delivery catheter set forth in any one of paragraphs 1 to 7, further comprising a distal occlusion balloon adjacent the distal end of the catheter body, the distal occlusion balloon configured to be expanded to be in apposition with a wall of the blood vessel at a location distal of the lesion treatment site to inhibit delivered activeagent solution from flowing passed the distal occlusion balloon, wherein the distal occlusion balloon is not a drug-coated balloon.9. The local drug-delivery catheter set forth in paragraph 8, further comprising a proximal occlusion balloon adjacent the distal end of the catheter body and spaced proximally from the distal occlusion balloon, the proximal occlusion balloon configured to be expanded to be in apposition with a wall of the blood vessel at a location proximal of the lesion treatment site to inhibit delivered active agent solution from flowing passed the proximal occlusion balloon, wherein the proximal occlusion balloon is not a drug-coated balloon.10. The local drug-delivery catheter set forth in any one of paragraphs 8 or 9, further comprising at least one energy emitter coupled to the catheter body adjacent the distal end thereof and proximal of the distal occlusion balloon, the at least one emitter configured to be selectively activated to emit energy toward the lesion treatment site to enhance uptake of the active agent into the wall of the blood vessel at the lesion treatment site.11. The local drug-delivery catheter set forth in paragraph 1, further comprising at least one energy emitter coupled to the catheter body adjacent the distal end thereof and adjacent the open distal end of the drug-delivery lumen, the at least one emitter configured to be selectively activated to emit energy toward the lesion treatment site to enhance uptake of the active agent into the wall of the blood vessel at the lesion treatment site.12. The local drug-delivery catheter set forth in any one of paragraphs 1 to 11, wherein the active agent solution includes an anti-proliferative agent.13. A local drug-delivery catheter for delivering an active agent to 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, the catheter body defining a drug-delivery lumen extending along the length of the catheter body, wherein the drug-delivery lumen has an open proximal end at or adjacent the proximal end of the catheter body, and an open distal end at or adjacent the distal end of the catheter body; and a distal occlusion balloon adjacent the distal end of the catheter body and distal of the open distal end of the drug-delivery lumen, the distal occlusion balloon configured to be expanded to be in apposition with a wall of the blood vessel at a location distal of thelesion treatment site to inhibit delivered active agent solution from flowing passed the distal occlusion balloon, wherein the distal occlusion balloon is not a drug-coated balloon. 14. The local drug-delivery catheter set forth in paragraph 13, further comprising a proximal occlusion balloon adjacent the distal end of the catheter body and spaced proximally from the distal occlusion balloon, the proximal occlusion balloon configured to be expanded to be in apposition with a wall of the blood vessel at a location proximal of the lesion treatment site to inhibit delivered active agent solution from flowing passed the proximal occlusion balloon, wherein the proximal occlusion balloon is not a drug-coated balloon.15. The local drug-delivery catheter set forth in any one of paragraphs 13 or 14, further comprising at least one energy emitter coupled to the catheter body adjacent the distal end thereof and proximal of the distal occlusion balloon, the at least one emitter configured to be selectively activated to emit energy toward the lesion treatment site to enhance uptake of the active agent into the wall of the blood vessel at the lesion treatment site.16. The local drug-delivery catheter set forth in paragraph 15, wherein the at least one energy emitter comprises an ultrasound emitter.17. A method of locally delivering a drug to a lesion treatment site having a lesion in a blood vessel without the use of a drug-coated balloon comprising: tracking a catheter to the lesion treatment site in a blood vessel such that a distal end of the catheter is adjacent the lesion treatment site, wherein the catheter is free from a drug-coated balloon; delivering an active agent solution from outside the blood vessel into a drug- delivery lumen of the catheter, wherein the active agent solution flows distally through the drug-delivery lumen and enters the blood vessel through a distal open end of the drug- delivery lumen at or adjacent the distal end of the catheter, whereby the active agent solution is directed toward the lesion treatment site.18. The method set forth in paragraph 17, further comprising modifying the lesion before said tracking a catheter and delivering an active agent to facilitate uptake of the active agent solution at the lesion treatment site.19. The method set forth in any one of paragraphs 17 or 18, further comprising emitting energy from one or more energy emitters coupled to the catheter body adjacentthe distal end thereof toward the lesion treatment site, wherein said emitting energy is performed before, during, or after said delivery an active agent.20. The method set forth in any one of paragraphs 17 to 19, further comprising inflating a distal occlusion balloon coupled to the catheter body such that the distal occlusion balloon is in apposition to a wall of the blood vessel at a location distal of the lesion treatment site.

[0036] 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.

[0037] 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).

[0038] 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 local drug-delivery catheter (10, 110, 210) for delivering an active agent to 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, the catheter body (12, 112, 212) having a drug-delivery lumen (14, 114, 214) extending along the length of the catheter body (12, 112, 212), wherein the drug-delivery lumen (14, 114, 214) has an open proximal end at or adjacent the proximal end of the catheter body (12, 112, 212), and an open distal end (20, 120, 220) at or adjacent the distal end of the catheter body (12, 112, 212); a source of active agent solution fluidly connected to the open proximal end of the drug-delivery lumen (14, 114, 214), the source of active agent solution including an active agent solution; and a fluid mover (18, 118, 218) in fluid communication with the source of active agent solution, the fluid mover (18, 118, 218) configured to deliver the active agent solution into and through the drug-delivery lumen (14, 114, 214) via force exerted on the active agent solution, whereby the active agent solution flows through the open distal end (20, 120, 220) of the drug-delivery lumen (14, 114, 214) and is delivered into the blood vessel at the lesion treatment site, wherein the local drug-delivery catheter (10, 110, 210) is free from a drug- coated balloon.

2. The local drug-delivery catheter (10, 110, 210) set forth in claim 1, wherein the open distal end (20) of the drug-delivery lumen (14, 114, 214) extends through the distal end of the catheter body (12, 112, 212).

3. The local drug-delivery catheter (10, 110, 210) set forth in claim 1, wherein the open distal end (120, 220) of the drug-delivery lumen (14, 114, 214) extends through a side wall of the catheter body (12, 112, 212) adjacent the distal end thereof.

4. The local drug-delivery catheter (10, 110, 210) set forth in claim 3, wherein the open distal end (20, 120, 220) of the drug-delivery lumen (14, 114, 214) includes a plurality of open distal ends (120, 220) spaced apart from one another along the length of the catheter body (12, 112, 212) adjacent the distal end thereof.

5. The local drug-delivery catheter (10, 110, 210) set forth in any one of claims 1 to 4, wherein the fluid mover (18, 118, 218) includes a positive displacement pump.

6. The local drug-delivery catheter (10, 110, 210) set forth in any one of claims 1 to 5, further comprising an aspirator (18, 118, 218) in fluid communication with the drug-delivery lumen (14, 114, 214) and configured to withdraw the active-agent solution that has been delivered into the blood vessel at the lesion treatment site back through the drug-delivery lumen (14, 114, 214).

7. The local drug-delivery catheter (10, 110, 210) set forth in claim 6, wherein the fluid mover (18, 118, 218) is configured as the aspirator.

8. The local drug-delivery catheter (10, 110, 210) set forth in any one of claims 1 to 7, further comprising a distal occlusion balloon (130, 230) adjacent the distal end of the catheter body (12, 112, 212), the distal occlusion balloon (130, 230) configured to be expanded to be in apposition with a wall of the blood vessel at a location distal of the lesion treatment site to inhibit delivered active agent solution from flowing passed the distal occlusion balloon (130, 230), wherein the distal occlusion balloon (130, 230) is not a drug-coated balloon.

9. The local drug-delivery catheter (10, 110, 210) set forth in claim 8, further comprising a proximal occlusion balloon (240) adjacent the distal end of the catheter body (12, 112, 212) and spaced proximally from the distal occlusion balloon (130,230), the proximal occlusion balloon (240) configured to be expanded to be in apposition with a wall of the blood vessel at a location proximal of the lesion treatment site to inhibit delivered active agent solution from flowing passed the proximal occlusion balloon (240), wherein the proximal occlusion balloon (240) is not a drug- coated balloon.

10. The local drug-delivery catheter (10, 110, 210) set forth in any one of claims 8 or 9, further comprising at least one energy emitter (250) coupled to the catheter body (12, 112, 212) adjacent the distal end thereof and proximal of the distal occlusion balloon (130, 230), the at least one emitter (250) configured to be selectively activated to emit energy toward the lesion treatment site to enhance uptake of the active agent into the wall of the blood vessel at the lesion treatment site.

11. The local drug-delivery catheter (10, 110, 210) set forth in claim 1, further comprising at least one energy emitter (250) coupled to the catheter body (12, 112, 212) adjacent the distal end thereof and adjacent the open distal end (220) of the drug- delivery lumen (14, 114, 214), the at least one emitter (250) configured to be selectively activated to emit energy toward the lesion treatment site to enhance uptake of the active agent into the wall of the blood vessel at the lesion treatment site.

12. The local drug-delivery catheter (10, 110, 210) set forth in any one of claims 1 to 11 , wherein the active agent solution includes an anti-proliferative agent.

13. A local drug-delivery catheter (110, 210) for delivering an active agent to 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, the catheter body (112, 212) defining a drug-delivery lumen (14, 114, 214) extending along the length of the catheter body (112, 212), wherein the drug-delivery lumen (14, 114, 214) has an open proximal end at or adjacent the proximal end of the catheter body (112, 212), and anopen distal end (20, 120, 220) at or adjacent the distal end of the catheter body (112, 212); and a distal occlusion balloon (130, 230) adjacent the distal end of the catheter body (112, 212) and distal of the open distal end (120, 220) of the drug-delivery lumen (14, 114, 214), the distal occlusion balloon (130, 230) configured to be expanded to be in apposition with a wall of the blood vessel at a location distal of the lesion treatment site to inhibit delivered active agent solution from flowing passed the distal occlusion balloon (130, 230), wherein the distal occlusion balloon (130, 230) is not a drug- coated balloon.

14. The local drug-delivery catheter (110, 210) set forth in claim 13, further comprising a proximal occlusion balloon (240) adjacent the distal end of the catheter body (112, 212) and spaced proximally from the distal occlusion balloon (130, 230), the proximal occlusion balloon (240) configured to be expanded to be in apposition with a wall of the blood vessel at a location proximal of the lesion treatment site to inhibit delivered active agent solution from flowing passed the proximal occlusion balloon (240), wherein the proximal occlusion balloon (240) is not a drug-coated balloon.

15. The local drug-delivery catheter (110, 210) set forth in any one of claims 13 or 14, further comprising at least one energy emitter (250) coupled to the catheter body (112, 212) adjacent the distal end thereof and proximal of the distal occlusion balloon (130, 230), the at least one emitter (250) configured to be selectively activated to emit energy toward the lesion treatment site to enhance uptake of the active agent into the wall of the blood vessel at the lesion treatment site.

Images