Drug Elution Device

Abstract

The drug eluting device includes: a handle including a balloon inflation port configured to receive inflation fluid, and a drug port configured to receive a drug; a shaft connected to the handle, the shaft including: a balloon inflation lumen configured to receive inflation fluid from the balloon inflation port, a drug lumen configured to receive a drug from the drug port, and a guidewire lumen configured to receive a guidewire and allow the guidewire to extend out of a distal portion of the shaft; a balloon attached to a distal portion of the shaft and configured to receive inflation fluid from the balloon inflation lumen; and a drug tube defining a distal portion of the drug lumen, the drug tube having a distal portion connected to the outside of the balloon, the drug tube having a plurality of holes configured to allow the drug to exit the drug tube.

Description

[Technical field]

[0001] This application relates generally to a drug eluting device for intravascular delivery of drugs, such as drugs including antiproliferative drugs, and more particularly to a drug eluting device that allows delivery of a drug through a drug tube to deliver the drug into a blood vessel without the drug passing through a balloon. [Background technology]

[0002] Vascular diseases can result in stenosis and restenosis of blood vessels, where the buildup of plaque on the walls of blood vessels leads to narrowing of the blood vessels, which is detrimental to health if the blood vessels are not treated. For example, blood vessels may be treated by delivering drugs, such as drugs that include anti-proliferative agents. In known methods, a drug eluting device that includes a balloon may be inserted into the blood vessel and advanced to the site of the narrowing of the blood vessel, where the drug may be delivered into a chamber within the balloon and then out of the balloon into the blood vessel through an opening in the balloon wall. Summary of the Invention

[0003] However, when the agent is delivered through openings in the balloon wall, due to the relatively large volume of the balloon, a significant amount of the agent may remain within the balloon after delivery. Embodiments of the present disclosure can be used to address this issue.

[0004] In some embodiments, the drug eluting device includes a handle including a balloon inflation port configured to receive an inflation fluid and a drug port configured to receive a drug. The drug eluting device also includes a shaft connected to the handle. The shaft includes a balloon inflation lumen configured to receive an inflation fluid from the balloon inflation port, a drug lumen configured to receive a drug from the drug port, and a guidewire lumen configured to receive a guidewire and allow the guidewire to extend out of a distal portion of the shaft. The drug eluting device also includes a balloon attached to a distal portion of the shaft and configured to receive inflation fluid from the balloon inflation lumen. The drug eluting device also includes a drug tube defining a distal portion of the drug lumen, the drug tube having a distal portion connected to the exterior of the balloon and including a plurality of holes configured to allow the drug to exit the drug tube.

[0005] In some embodiments, the drug eluting device includes a handle including a drug port configured to receive a drug. The drug eluting device also includes a carrier tube connected or connectable to the handle, the carrier tube including a lumen. The drug eluting device also includes a drug tube configured to travel through the lumen of the carrier tube. The drug tube includes a proximal portion configured to receive the drug from the drug port and a distal portion including a plurality of holes configured to allow the drug to exit the drug tube. When the distal portion of the drug tube is located within the carrier tube, the distal portion of the drug tube is held by the carrier tube in a deformed radially collapsed state. When the distal portion of the drug tube is outside of the carrier tube, the distal portion of the drug tube is in a relaxed radially expanded state.

[0006] In some embodiments, a method of delivering a drug into a vessel includes providing a drug eluting device. The drug eluting device includes a handle including a balloon inflation port configured to receive an inflation fluid and a drug port configured to receive a drug. The drug eluting device also includes a shaft connected to the handle. The shaft includes a balloon inflation lumen configured to receive an inflation fluid from the balloon inflation port, a drug lumen configured to receive a drug from the drug port, and a guidewire lumen configured to receive a guidewire and allow the guidewire to extend out of a distal portion of the shaft. The drug eluting device also includes a balloon attached to a distal portion of the shaft and configured to receive an inflation fluid from the balloon inflation lumen. The drug eluting device also includes a drug tube defining a distal portion of the drug lumen, the drug tube having a distal portion connected to an exterior of the balloon and including a plurality of holes configured to allow the drug to exit the drug tube. The method also includes inserting a distal portion of the shaft into the vessel. The method also includes inflating the balloon by supplying an inflation fluid to the balloon through the balloon inflation tube, which causes a distal portion of the drug tube to assume a deformed, radially expanded state. The method also includes delivering a drug into the vessel through the drug tube and a plurality of holes in the drug tube.

[0007] In some embodiments, a method of delivering a drug into a vessel includes providing a drug eluting device. The drug eluting device includes a handle including a balloon inflation port configured to receive an inflation fluid and a drug port configured to receive a drug. The drug eluting device also includes a shaft connected to the handle. The shaft includes a balloon inflation lumen configured to receive an inflation fluid from the balloon inflation port, a drug lumen configured to receive a drug from the drug port, and a guidewire lumen configured to receive a guidewire and allow the guidewire to extend out of a distal portion of the shaft. The drug eluting device also includes a balloon attached to a distal portion of the shaft and configured to receive an inflation fluid from the balloon inflation lumen. The drug eluting device also includes a carrier tube connected to the handle, the carrier tube configured to allow the shaft to travel therethrough. The carrier tube has a length equal to or greater than a length of the shaft. The drug eluting device also includes a drug tube defining a distal portion of the drug lumen, the drug tube having a distal portion connected to an exterior of the balloon and including a plurality of holes configured to allow the drug to exit the drug tube. The method also includes inserting a distal portion of the shaft into the vessel. The method also includes pushing the shaft or pulling the carrier tube such that a distal portion of the drug tube and the balloon are outside of the carrier tube, which causes the distal portion of the drug tube to assume a relaxed, radially expanded state. The method also includes inflating the balloon by supplying an inflation fluid to the balloon via a balloon inflation tube. The method also includes delivering a drug into the vessel through the drug tube and a plurality of holes in the drug tube.

[0008] In some embodiments, a method of delivering an agent into a vessel includes providing a drug eluting device. The drug eluting device includes a handle including a balloon inflation port configured to receive an inflation fluid and a drug port configured to receive an agent. The drug eluting device also includes a shaft connected to the handle. The drug eluting device also includes a shaft connected to the handle. The shaft includes a balloon inflation lumen configured to receive an inflation fluid from the balloon inflation port, a drug lumen configured to receive an agent from the drug port, and a guidewire lumen configured to receive a guidewire and allow the guidewire to extend out of a distal portion of the shaft. The drug eluting device also includes a balloon attached to a distal portion of the shaft and configured to receive an inflation fluid from the balloon inflation lumen. The drug eluting device also includes a carrier tube connected or connectable to the handle, the carrier tube configured to allow the shaft to travel therethrough. The carrier tube is configured to be attached to a guide catheter. The drug eluting device also includes a drug tube defining a distal portion of the drug lumen, the drug tube having a distal portion connected to an exterior of the balloon and including a plurality of holes configured to allow the drug to exit the drug tube. The carrier tube has a length approximately equal to an axial length of the distal portion of the drug tube. The method also includes inserting a distal portion of the shaft into the vessel. The method also includes pushing the shaft such that the distal portion of the drug tube and the balloon are outside of the carrier tube and guide catheter, which causes the distal portion of the drug tube to assume a relaxed, radially expanded state. The method also includes inflating the balloon by providing inflation fluid to the balloon via a balloon inflation tube. The method also includes delivering a drug into the vessel through the drug tube and a plurality of holes in the drug tube.

[0009] In some embodiments, a method of delivering an agent into a vessel includes providing a drug eluting device. The drug eluting device includes a handle including a drug port configured to receive an agent. The drug eluting device also includes a carrier tube connected to the handle, the carrier tube including a lumen. The drug eluting device also includes a drug tube configured to travel through the lumen of the carrier tube. The drug tube includes a proximal portion configured to receive an agent from the drug port and a distal portion including a plurality of holes configured to allow the agent to exit the drug tube. When the distal portion of the drug tube is located within the carrier tube, the distal portion of the drug tube is held by the carrier tube in a deformed radially collapsed state. When the distal portion of the drug tube is outside of the carrier tube, the distal portion of the drug tube is in a relaxed radially expanded state. The carrier tube has a length that is equal to or greater than an axial length of the drug tube. The method also includes inserting the distal portion of the carrier tube into the vessel. The method also includes pushing the drug tube or pulling the carrier tube such that a distal portion of the drug tube is outside of the carrier tube, which causes the distal portion of the drug tube to assume a relaxed radially expanded state, the drug tube receiving the drug from the drug port. The method also includes delivering the drug into the vessel through the drug tube and a plurality of holes in the drug tube.

[0010] In some embodiments, a method of delivering an agent into a vessel includes providing a drug eluting device. The drug eluting device includes a handle including a drug port configured to receive an agent. The drug eluting device also includes a carrier tube connected or connectable to the handle, the carrier tube including a lumen. The carrier tube is configured to be attached to a guide catheter. The drug eluting device also includes a drug tube configured to travel through the lumen of the carrier tube. The drug tube includes a proximal portion configured to receive an agent from the drug port and a distal portion including a plurality of holes configured to allow the agent to exit the drug tube. When the distal portion of the drug tube is located within the carrier tube, the distal portion of the drug tube is held by the carrier tube in a deformed radially collapsed state. When the distal portion of the drug tube is outside of the carrier tube, the distal portion of the drug tube is in a relaxed radially expanded state. The carrier tube has a length approximately equal to an axial length of the distal portion of the drug tube. The method also includes inserting the distal portion of the carrier tube into the vessel. The method also includes pushing the drug tube so that a distal portion of the drug tube is outside of the carrier tube and the guide catheter, which causes the distal portion of the drug tube to assume a relaxed radially expanded state, the drug tube receiving the drug from the drug port. The method also includes delivering the drug into the vessel through the drug tube and the plurality of holes in the drug tube. [Brief description of the drawings]

[0011] The above and other features of the present disclosure will become more fully apparent from the following description and appended claims, taken in conjunction with the accompanying drawings, in which: The present disclosure is described with additional specificity and detail through the use of the accompanying drawings, with the understanding that these drawings illustrate only some embodiments in accordance with the present disclosure and therefore should not be considered as limiting its scope.

[0012] [Figure 1]FIG. 2 is a left side view of a first embodiment of a drug eluting device with a distal portion of the drug tube in a radially expanded state.

[0013] [Figure 2A] FIG. 1 is a left side view of a portion of a drug-eluting device according to a first embodiment.

[0014] [Figure 2B] FIG. 1 is a left side view of a portion of a drug-eluting device according to a first embodiment.

[0015] [Figure 3A] 2B is a cross-sectional view of a portion of a drug-eluting device according to a first embodiment taken along plane AA of FIG. 2A.

[0016] [Figure 3B] 2B is a cross-sectional view of a portion of a drug-eluting device according to a first embodiment taken along plane BB of FIG. 2A.

[0017] [Figure 3C] 2B is a cross-sectional view of a portion of a drug-eluting device according to a first embodiment taken along plane CC of FIG. 2A.

[0018] [Figure 4A] 2B is a cross-sectional view of a portion of a drug-eluting device according to a first embodiment taken along plane AA of FIG. 2A.

[0019] [Figure 4B] 2B is a cross-sectional view of a portion of a drug-eluting device according to a first embodiment taken along plane BB of FIG. 2A.

[0020] [Figure 4C] 2B is a cross-sectional view of a portion of a drug-eluting device according to a first embodiment taken along plane CC of FIG. 2A.

[0021] [Figure 5A] 2B is a cross-sectional view of a portion of a drug-eluting device according to a first embodiment taken along plane AA of FIG. 2A.

[0022] [Figure 5B] 2B is a cross-sectional view of a portion of a drug-eluting device according to a first embodiment taken along plane BB of FIG. 2A.

[0023] [Figure 5C] 2B is a cross-sectional view of a portion of a drug-eluting device according to a first embodiment taken along plane CC of FIG. 2A.

[0024] [Figure 6A] 2B is a cross-sectional view of a portion of a drug-eluting device according to a first embodiment taken along plane AA of FIG. 2A.

[0025] [Figure 6B] 2B is a cross-sectional view of a portion of a drug-eluting device according to a first embodiment taken along plane BB of FIG. 2A.

[0026] [Figure 6C] 2B is a cross-sectional view of a portion of a drug-eluting device according to a first embodiment taken along plane CC of FIG. 2A.

[0027] [Figure 7A] 2B is a cross-sectional view of a portion of a drug-eluting device according to a first embodiment taken along plane AA of FIG. 2A.

[0028] [Figure 7B] 2B is a cross-sectional view of a portion of a drug-eluting device according to a first embodiment taken along plane BB of FIG. 2A.

[0029] [Figure 7C] 2B is a cross-sectional view of a portion of a drug-eluting device according to a first embodiment taken along plane CC of FIG. 2A.

[0030] [Figure 8] FIG. 2 is a left side view of a portion of a first embodiment of a drug eluting device, showing a distal portion of a drug tube extending in a helical configuration.

[0031] [Figure 9A] FIG. 1 is a left side view of a drug eluting device according to a first embodiment, where a distal portion of the drug tube has multiple branched drug channels.

[0032] [Figure 9B] 9B is a view of a portion of the distal portion of the drug tube of the first embodiment of FIG. 9A, indicated by arrow X in FIG. 9A, where the distal portion of the drug tube has a lattice shape.

[0033] [Figure 10A] FIG. 13 is a left side view of a drug-eluting device according to a second embodiment, with a distal portion of the drug tube in a relaxed radially expanded state and extending in a helical configuration.

[0034] [Figure 10B] FIG. 10B is a left side view of the drug tube according to the second embodiment of FIG. 10A.

[0035] [Figure 11A] FIG. 13 is a left side view of a portion of a drug-eluting device according to a second embodiment, the distal portion of the drug tube being in a relaxed radially expanded state, the drug tube having multiple drug tube segments extending from the proximal end of the distal portion to the distal end of the distal portion and curving radially outward relative to the longitudinal axis of the carrier tube.

[0036] [Figure 11B] FIG. 11B is a left side view of the drug tube of the second embodiment of FIG. 11A.

[0037] [Figure 12A] FIG. 1 is a right side view of a drug elution device for use with a short carrier tube and guide catheter in a first configuration.

[0038] [Figure 12B] FIG. 13 is a right side view of the drug eluting device for use with a short carrier tube and guide catheter in a second configuration.

[0039] [Figure 12C] FIG. 13 is a right side view of the drug eluting device for use with a short carrier tube and guide catheter in a third configuration.

[0040] [Figure 12D] FIG. 13 is a right side view of the drug eluting device for use with a short carrier tube and guide catheter in a fourth configuration.

[0041] [Figure 13A] FIG. 1 is a right side view of a drug elution device for use with a long carrier tube in a first configuration.

[0042] [Figure 13B] FIG. 13 is a right side view of the drug elution device for use with a long carrier tube in a second configuration.

[0043] [Figure 13C] FIG. 13 is a right side view of the drug elution device for use with a long carrier tube in a third configuration.

[0044] [Figure 14A] FIG. 2 is a right side view of a distal portion of a drug eluting device for use with an inserter, valve, guide catheter, and flushing device in a first configuration.

[0045] [Figure 14B] FIG. 13 is a right side view of a distal portion of a drug eluting device for use with an inserter, valve, guide catheter, and flushing device in a second configuration.

[0046] [Figure 14C] FIG. 13 is a right side view of a distal portion of a drug eluting device for use with an inserter, valve, guide catheter, and flushing device in a third configuration.

[0047] [Figure 14D]FIG. 13 is a right side view of a distal portion of a drug eluting device for use with an inserter, valve, guide catheter, and flushing device in a fourth configuration. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0048] In the following detailed description, reference is made to the accompanying drawings, which form a part of this specification. In the drawings, like symbols typically identify like elements unless the context dictates otherwise. The exemplary embodiments described in the detailed description, drawings, and claims are not intended to be limiting. Other embodiments may be utilized, and other changes may be made, without departing from the spirit or scope of the subject matter presented herein. It will be readily understood that the aspects of the present disclosure, as generally described herein and illustrated in the figures, can be arranged, substituted, combined, and designed in a wide variety of different configurations, all of which are expressly contemplated as part of this disclosure.

[0049] In order to deliver a drug into a vessel using a drug eluting device, it may be desirable to deliver the drug through a structure other than the balloon, i.e., not directly through an opening in the balloon wall.

[0050] Various embodiments of the drug eluting devices described herein may provide one or more advantages including, for example: (1) allowing the inflation fluid for the balloon to be different from the drug delivered into the vessel to reduce waste of drug that would otherwise remain in the balloon after the drug is delivered to the vessel; and (2) allowing the drug to be delivered into the vessel via the drug eluting device without a balloon.

[0051] Various embodiments of the drug eluting device described herein may be used with a guide catheter. The guide catheter may be inserted into the vessel before the drug eluting device is inserted. The drug eluting device may be connected to a guide catheter to facilitate the entry of portions of the drug eluting device into the vessel. The use of a guide catheter may protect the vessel from potential trauma that may be caused by using the drug eluting device without a guide catheter. The guide catheter may be positioned at or near the target of drug elution.

[0052] Various embodiments of the drug eluting device described herein may be used with a carrier tube. The carrier tube may surround the drug tube and / or balloon of the drug eluting device. The carrier tube may facilitate entry of a portion of the drug eluting device into a vessel. Use of the carrier tube may provide an external force to a distal portion of the drug eluting device to hold the distal portion of the drug eluting device in a deformed radially compressed state. The carrier tube is placed at or near the target for drug elution.

[0053] First embodiment

[0054] 1-9B show a drug eluting device 100 (e.g., a treatment device, etc.) for delivering a drug (e.g., a drug including an antiproliferative agent such as sirolimus) into a vessel according to a first embodiment. The drug eluting device 100 includes a handle 106 including a balloon inflation port 102 configured to receive an inflation fluid and a drug port 104 configured to receive a drug. The drug eluting device 100 also includes a shaft 110 connected to the handle 106. The shaft 110 includes a balloon inflation lumen 113 configured to receive an inflation fluid from the balloon inflation port 102, a drug lumen 114 configured to receive a drug from the drug port 104, and a guidewire lumen 117 configured to receive a guidewire 126 and allow the guidewire 126 to extend out of a distal portion 110d of the shaft 110. The drug eluting device 100 also includes a balloon 130 attached to the distal portion 110d of the shaft 110 and configured to receive an inflation fluid from a balloon inflation tube 112. The drug eluting device 100 also includes a drug tube 140 that defines a distal portion 114d of the drug lumen 114, the drug tube 140 having a distal portion 140d connected to the exterior (outside) 130e of the balloon 130 and including a plurality of holes 142 configured to allow the drug to exit the drug tube 140. In some embodiments, the drug eluting device 100 may further include a carrier tube 160 connected or connectable to the handle 106. The carrier tube 160 is configured to allow the shaft 110 to move therethrough. In some embodiments, the handle 106 includes an actuator 108 configured to move the shaft 110 relative to the carrier tube 160 or to move the carrier tube 160 relative to the shaft 110. In some embodiments, the drug eluting device 100 may further include a guidewire tube 116 in which a guidewire lumen 117 is formed. In some embodiments, the drug eluting device 100 may further include a balloon inflation tube 112 in which a balloon inflation lumen 113 is formed.

[0055] The drug eluting device 100 includes a handle 106 (e.g., a grip, a hand grip, etc.). The handle 106 is configured to be held by a user and allows the user to manipulate the drug eluting device 100. The handle 106 may be configured to be held in one hand to allow the user to perform additional manipulations using a second hand.

[0056] The handle 106 may be made of polyethylene, polyolefins (e.g., polypropylene, polyamide), polyesters (e.g., polyethylene terephthalate), fluoropolymers (such as polytetrafluoroethylene (PTFE)), ethylene / tetrafluoroethylene copolymers (ETFE), polyetheretherketone (PEEK), polyamides, elastomers, polyester elastomers, polycarbonate, polyetherimide, polystyrene, polyacetal, ABS (acrylonitrile, butadiene, styrene copolymer composite) resin, or other suitable materials.

[0057] The handle 106 also includes a balloon inflation port 102 (e.g., a hole, opening, aperture, etc.) configured to receive an inflation fluid. The inflation fluid may be saline, contrast, a mixture of saline and contrast, or other suitable inflation fluid. In FIG. 1, the balloon inflation port 102 is located on the proximal side of the handle 106. However, in other embodiments, the balloon inflation port 102 may be located above, below, to the left, to the right, or on the proximal side of the handle 106. In yet other embodiments, the balloon inflation port 102 may be located on the proximal portion 110p of the shaft 110.

[0058] The handle 106 also includes an agent port 104 (e.g., a hole, opening, aperture, etc.) configured to receive an agent. In FIG. 1, the agent port 104 is located on the proximal side of the handle 106. However, in other embodiments, the agent port 104 may be located above, below, to the left, to the right, or on the proximal side of the handle 106. In yet other embodiments, the agent port 104 may be located on the proximal portion 110p of the shaft 110.

[0059] In some embodiments, the handle 106 includes an actuator 108 (tab, button, wheel, knob, etc.). The actuator 108 may be a mechanical structure actuatable by a user to operate the drug eluting device 100. In FIG. 1 , the actuator 108 is located on the upper side of the handle 106. However, in other embodiments, the actuator 108 may be located on the lower, left, or right side of the handle 106. In some embodiments, the actuator 108 is configured to move a shaft 110 relative to the carrier tube 160. The shaft 110 is oriented along a longitudinal axis A. L and / or may rotate clockwise or counterclockwise about a longitudinal axis A. L In another embodiment, the actuator 108 is configured to move the carrier tube 160 relative to the shaft 110. The carrier tube 160 may move longitudinally along a longitudinal axis A. L and / or the longitudinal axis A L can be moved longitudinally along

[0060] The drug eluting device 100 also includes a shaft 110 (e.g., a catheter, a tube, a pipe, a cylinder, a conduit, etc.). The shaft 110 is connected to the handle 106. The shaft 110 may be connected to the handle 106 by adhesive bonding, by an interlocking mechanism, by a press fit, by threaded fasteners, or by other suitable connection methods. The shaft may be permanently fixed to the handle 106 such that a user cannot remove the shaft 110 from the handle 106. The shaft 110 may have a cap 111 on a distal portion 110d of the shaft 110.

[0061] The shaft 110 may be made of a fluoropolymer (e.g., polytetrafluoroethylene (PTFE)), ethylene / tetrafluoroethylene copolymer (ETFE), polyetheretherketone (PEEK), polyurethane, polyamide elastomer, polyester elastomer, polyurethane elastomer, polyimide, polycarbonate, polyetherimide, or other suitable material.

[0062] The shaft 110 may have a length in the range of about 30-300 cm, for example, 50-300 cm, or 100-250 cm. As used herein, a range from X to Y includes X, Y, and values ​​between X and Y.

[0063] Shaft 110 may have a cross-sectional shape that is circular, elliptical, polygonal, rounded polygonal, or other geometric shape. Shaft 110 may have a maximum cross-sectional width (e.g., diameter when the cross-sectional shape is circular) in the range of about 0.5-10 mm, inclusive, ideally 0.5-7 mm.

[0064] 2A and 2B show a portion of a drug eluting device 100. The drug eluting device 100 can be a rapid exchange type device, where the guidewire 126 enters the shaft 110 at a location on the shaft 110 distal to where the shaft 110 is connected to the handle 106. In other embodiments, the drug eluting device 100 can be an over-the-wire type device, where the guidewire 126 passes through the handle 106 and enters the shaft 110.

[0065] In Figures 3A-3C, shaft 110 is solid. Shaft 110 includes balloon inflation lumen 113 (e.g., cavity, space, etc.), drug lumen 114 (e.g., cavity, space, etc.), and guidewire lumen 117 (e.g., pipe, cylinder, conduit, etc.). Figures 3A-3C show cross-sectional views of solid shaft 110 at planes AA, BB, and CC, respectively, of Figure 2A. In the embodiment of Figures 3A-3C, balloon inflation lumen 113, drug lumen 114, and guidewire lumen 117 are separate from one another.

[0066] Balloon inflation lumen 113 extends longitudinally through shaft 110. Balloon inflation lumen 113 is configured to receive an agent from balloon inflation port 102. Balloon inflation lumen 113 may have a cross-sectional shape that is circular, elliptical, polygonal, rounded polygonal, or other geometric shape. Balloon inflation lumen 113 may have a maximum cross-sectional width (e.g., diameter when the cross-sectional shape is circular) in the range of about 1 μm-15 mm, inclusive, e.g., 0.1-3 mm.

[0067] The drug lumen 114 extends longitudinally through the shaft 110. The drug lumen 114 is configured to receive a drug from the drug port 104. The drug lumen 114 may have a cross-sectional shape that is circular, elliptical, polygonal, rounded polygonal, or other geometric shape. The drug lumen 114 may have a maximum cross-sectional width (e.g., diameter when the cross-sectional shape is circular) that is in the range of about 1 μm-15 mm, inclusive, and ideally 0.1-3 mm.

[0068] Guidewire lumen 117 extends longitudinally through shaft 110. Guidewire lumen 117 is configured to receive a guidewire 126. Guidewire lumen 117 may have a cross-sectional shape that is circular, elliptical, polygonal, rounded polygonal, or other geometric shape. Guidewire lumen 117 may have a maximum cross-sectional width (e.g., diameter when the cross-sectional shape is circular) in the range of about 1-15 mm, inclusive, e.g., 1-3 mm.

[0069] 3A-3C, balloon inflation lumen 113, drug lumen 114, and guidewire lumen 117 are positioned within shaft 110 such that balloon inflation lumen 113 is located at the bottom left of shaft 110, drug lumen 114 is located at the bottom right of shaft 110, and guidewire lumen 117 is located at the top of shaft 110. In other embodiments, balloon inflation lumen 113, drug lumen 114, and guidewire lumen 117 may be positioned at other locations on shaft 110 and in different relative orientations to one another as compared to the orientations in FIGS.

[0070] In Figures 4A-7C, the shaft 110 is hollow and has a shaft lumen 110U (e.g., a cavity, space, etc.). The shaft 110 may include a balloon inflation tube 112 (e.g., a pipe, cylinder, conduit, etc.), a proximal portion 140p of a drug tube 140 (e.g., a pipe, cylinder, conduit, etc.), and / or a guidewire tube 116 (e.g., a pipe, cylinder, conduit, etc.). Figures 4A-4C show cross sections of the shaft 110 in planes AA, BB, and CC, respectively, of Figure 2A. In the embodiment of Figures 4A-4C, the guidewire tube 116 is separated from the proximal portion 140p of the drug tube 140. Figures 5A-5C show cross sections of the shaft 110 in planes AA, BB, and CC, respectively, of Figure 2A. In the embodiment of Figures 5A-5C, the shaft 110 does not have a separate balloon inflation tube 112, the shaft lumen 110U of the shaft 110 is used as the balloon inflation lumen 113 for receiving inflation fluid, and the guidewire tube 116 extends through the proximal portion 140p of the drug tube 140. Figures 6A-6C show cross sections of the shaft 110 in the planes AA, BB, and CC, respectively, of Figure 2A. In the embodiment of Figures 6A-6C, the shaft 110 does not have a separate balloon inflation tube 112, and the shaft lumen 110U of the shaft 110 is used as the balloon inflation lumen 113 for receiving inflation fluid. Figures 7A-7C show cross sections of the shaft 110 in the planes AA, BB, and CC, respectively, of Figure 2A. In the embodiment of FIGS. 7A-7C, shaft 110 does not have a separate guidewire tube 116, and shaft lumen 110U of shaft 110 is used as a guidewire lumen 117 to directly receive guidewire 126.

[0071] A balloon inflation tube 112 extends longitudinally through the shaft 110. A balloon inflation lumen 113 is formed within the balloon inflation tube 112. The balloon inflation tube 112 may have a cross-sectional shape that is circular, elliptical, polygonal, rounded polygonal, or other geometric shape. The balloon inflation tube 112 may have a maximum cross-sectional width (e.g., diameter when the cross-sectional shape is circular) that is in the range of about 0.1-1 mm, inclusive, e.g., 0.3-0.9 mm.

[0072] The balloon inflation tube 112 may be made of a fluoropolymer (e.g., polytetrafluoroethylene (PTFE)), ethylene / tetrafluoroethylene copolymer (ETFE), polyetheretherketone (PEEK), polyurethane, polyamide elastomer, polyester elastomer, polyurethane elastomer, polyimide, polycarbonate, polyetherimide, or other suitable material.

[0073] A proximal portion 140p of the drug tube 140 extends longitudinally through the shaft 110. The drug lumen 114 is formed in the proximal portion 140p of the drug tube 140. The proximal portion 140p of the drug tube 140 may have a cross-sectional shape that is circular, elliptical, polygonal, rounded polygonal, or other geometric shape. The proximal portion 140p of the drug tube 140 may have a maximum cross-sectional width (e.g., diameter when the cross-sectional shape is circular) in the range of about 0.1-1 mm, inclusive, and ideally 0.3-0.9 mm.

[0074] Guidewire tube 116 is configured to receive guidewire 126 and allow guidewire 126 to extend out of distal portion 110d of shaft 110, as shown in Figures 2A and 2B. Guidewire lumen 117 is formed within guidewire tube 116. Guidewire tube 116 extends longitudinally through a portion of shaft 110 and through balloon 130. Guidewire tube 116 may have a cross-sectional shape that is circular, elliptical, polygonal, rounded polygonal, or other geometric shape. Guidewire tube 116 may have a maximum cross-sectional width (e.g., diameter when the cross-sectional shape is circular) in the range of about 0.1-1 mm, inclusive, ideally 0.3-0.9 mm.

[0075] The guidewire tube 116 may be made of a fluoropolymer (e.g., polytetrafluoroethylene (PTFE)), ethylene / tetrafluoroethylene copolymer (ETFE), polyetheretherketone (PEEK), polyurethane, polyamide elastomer, polyester elastomer, polyurethane elastomer, polyimide, polycarbonate, polyetherimide, or other suitable material.

[0076] 4A-4C, the balloon inflation tube 112, the proximal portion 140p of the drug tube 140, and the guidewire tube 116 are positioned within the shaft 110 such that the balloon inflation tube 112 is located at the bottom left of the shaft 110, the proximal portion 140p of the drug tube 140 is located at the bottom right of the shaft 110, and the guidewire tube 116 is located at the top of the shaft 110. In other embodiments, the balloon inflation tube 112, the proximal portion 140p of the drug tube 140, and the guidewire tube 116 may be positioned at other locations on the shaft 110 or in different relative positions to one another as compared to the positions in FIGS.

[0077] 6A-6C, proximal portion 140p of drug tube 140 and guidewire tube 116 are positioned within shaft 110 such that proximal portion 140p of drug tube 140 is at the bottom right of shaft 110 and guidewire tube 116 is at the top of shaft 110. In other embodiments, proximal portion 140p of drug tube 140 and guidewire tube 116 may be positioned at other locations on shaft 110 and in different relative positions to one another as compared to the positions in FIGS.

[0078] 7A-7C, the balloon inflation tube 112, the proximal portion 140p of the drug tube 140, and the guidewire 126 are positioned within the shaft 110 such that the balloon inflation tube 112 is located at the bottom left of the shaft 110, the proximal portion 140p of the drug tube 140 is located at the bottom right of the shaft 110, and the guidewire 126 is located at the top of the shaft 110. In other embodiments, the balloon inflation tube 112, the proximal portion 140p of the drug tube 140, and the guidewire 126 may be positioned at other locations on the shaft 110 or in different relative positions to one another as compared to the positions in FIGS.

[0079] In embodiments in which the shaft 110 is hollow and has a shaft lumen 110U, the shaft 110 has a cap 111 at a distal portion 110d of the shaft 110, as shown in FIGURE 2B. The cap 111 at the distal portion 110d of the shaft 110 may extend around the balloon inflation tube 112 and the guidewire tube 116 such that the balloon inflation tube 112 and the guidewire tube 116 extend through the cap 111 of the shaft 110. The cap 111 of the shaft 110 prevents inflation fluid that enters the balloon 130 from the balloon inflation tube 112 from entering the shaft lumen 110U of the shaft 110, as shown in FIGURE 2B.

[0080] Guidewire tube 116 extends through balloon 130 and out of balloon 130 through a hole in the distal end 130d of balloon 130. Distal end 130d of balloon 130 may be connected to the outside of guidewire tube 116 by adhesive bonding or other suitable methods, as shown in FIG. 2B.

[0081] The drug eluting device 100 also includes a balloon 130. The balloon 130 is attached to the distal portion 110d of the shaft 110. The balloon 130 may be attached to the distal portion 110d of the shaft 110 by being placed over the distal portion 110d of the shaft 110 and glued thereto, or by other suitable connection methods. The balloon 130 is configured to receive inflation fluid from the balloon inflation tube 112. When the inflation fluid enters the balloon 130 from the balloon inflation tube 112, the balloon 130 inflates.

[0082] The balloon 130 may be made of polyamide, polyester, polyurethane, polyamide elastomer, polyester elastomer, polyurethane elastomer, or other suitable material.

[0083] The balloon 130 may have a length in the range of about 10 to 400 mm. The balloon 130 may have a width in the range of about 1 to 8 mm.

[0084] The drug eluting device 100 also includes a drug tube 140 (e.g., a pipe, a cylinder, a conduit, etc.). The drug tube 140 defines a distal portion 114d of the drug lumen 114. The drug tube 140 is configured to receive a drug from the drug lumen 114. In an embodiment with a hollow shaft 110 having a shaft lumen 110U, the drug tube 140 has a proximal portion 140p extending longitudinally through the shaft 110, the drug lumen 114 is formed in the proximal portion 140p of the drug tube 140, and the drug tube 140 has a distal portion 140d that is outside the shaft 110 at the distal portion 110d of the shaft 110. The distal portion 140d of the drug tube 140 is connected to the exterior 130e of the balloon 130. In embodiments with a solid shaft 110, the agent lumen 114 extends longitudinally through the shaft 110, the agent tube 140 defines a distal portion 114d of the agent lumen 114, the agent tube 140 is exterior to the shaft 110 at the distal portion 110d of the shaft 110, and the agent tube 140 is connected to the exterior portion 130e of the balloon 130. The agent tube 140 of the embodiment with a solid shaft 110 is equivalent to the distal portion 140d of the agent tube 140 of the embodiment with a hollow shaft 110 having a shaft lumen 110U.

[0085] At least the distal portion 140d of the drug tube 140 may be made of an elastically deformable material. In some embodiments, the drug tube 140 may be made of Nitinol or stainless steel.

[0086] In embodiments in which the drug tube 140 comprises a hollow shaft 110 having a shaft lumen 110U with a proximal portion 140p extending longitudinally through the shaft 110 and a distal portion 140d that is external to the shaft 110, the drug tube 140 may have an axial length 150 in the range of about 30 to 330 cm, e.g., 50-330 cm, or 100-250 cm. The axial length 150 of the drug tube 140 is measured along the longitudinal axis A as shown in FIG. LThe distal portion 140d of the drug tube 140 may have an axial length 151 in the range of about 30 to 300 mm, e.g., 50-300 mm, or 100-250 mm. The axial length 151 of the distal portion 140d of the drug tube 140 is measured along the longitudinal axis A as shown in FIG. 2A. L is measured along the

[0087] In embodiments with a solid shaft 110 where the drug tube 140 is external to the shaft 110, the drug tube 140 may have an axial length of 30 to 300 mm, e.g., 50-300 mm, or 100-250 mm (similar to the axial length 151 of the distal portion of the drug tube 140 in embodiments with a hollow shaft 110). The axial length of the drug tube 140 is measured along the longitudinal axis A as shown in FIG. 2A. L is measured along the

[0088] The drug tube 140 may have a cross-sectional shape that is circular, elliptical, polygonal, rounded polygonal, or other geometric shape. The drug tube 140 may have a maximum cross-sectional width (e.g., diameter when the cross-sectional shape is circular) in the range of about 0.1-1 mm, inclusive, and ideally 0.3-0.9 mm.

[0089] The distal portion 140d of the drug tube 140 includes a plurality of holes 142 (e.g., apertures, openings, slits, etc.) configured to allow the drug to exit the distal portion 140d of the drug tube 140. When the distal portion 140d of the drug tube 140 assumes a radially expanded state 144a, which may be a deformed radially expanded state 144a or a relaxed radially expanded state 144a, the drug passes through the plurality of holes 142 in the distal portion 140d of the drug tube 140 to exit the drug tube 140 and enter the vessel. In some embodiments, the plurality of holes 142 are aligned along the longitudinal axis A of the shaft 110, as shown in FIG. 8 . L The drug tube 140 is disposed radially outwardly RO with respect to the drug tube 140 .

[0090] The holes 142 in the distal portion 140d of the drug tube 140 may be fabricated by laser drilling. The holes 142 in the distal portion 140d of the drug tube 140 may each have a width ranging from about 100 nm to 10 um, ideally 100 nm to 5 um. In FIG. 1, the holes 142 in the distal portion 140d of the drug tube 140 have the same width. However, in other embodiments, the holes 142 in the distal portion 140d of the drug tube 140 may have different widths.

[0091] The plurality of holes 142 in the distal portion 140d of the drug tube 140 may each have a shape that is a circle, an oval, a rounded polygon, a slit, or other geometric shape. In FIG. 1, the plurality of holes 142 in the distal portion 140d of the drug tube 140 have the same shape. However, in other embodiments, the plurality of holes 142 in the distal portion 140d of the drug tube 140 may have different shapes.

[0092] 1, the holes 142 in the distal portion 140d of the drug tube 140 are uniformly spaced apart between the holes 142 in the distal portion 140d of the drug tube 140. However, in other embodiments, the holes 142 in the distal portion 140d of the drug tube 140 may be variously spaced apart between the holes 142 in the distal portion 140d of the drug tube 140.

[0093] In some embodiments, prior to the inflation of the balloon 130, the distal portion 140d of the drug tube 140 is in a relaxed radially collapsed state, and when the balloon 130 is inflated with an inflation fluid, the distal portion 140d of the drug tube 140 is expanded to a deformed radially expanded state 144a by the inflation of the balloon 130. In these embodiments, the deformed state of the distal portion 140d of the drug tube 140 is the deformed expanded state 144a. The deformed state is a state in which an external force is applied to the distal portion 140d of the drug tube 140. In these embodiments, the relaxed state of the distal portion 140d of the drug tube 140 is a relaxed radially collapsed state. The relaxed state is a state in which no external force is applied to the distal portion 140d of the drug tube 140. When the balloon 130 is inflated, the expansion of the balloon 130 provides an external force that forces the distal portion 140d of the drug tube 140 into a deformed radially expanded state 144a. When the balloon 130 is no longer inflated, and thus no longer exerts an external force on the distal portion 140d of the drug tube 140, the distal portion 140d of the drug tube 140 changes from the deformed radially expanded state 144a to a relaxed radially collapsed state.

[0094] In some embodiments, the drug eluting device 100 may also include a carrier tube 160 (e.g., a sheath, a guide sheath, a cover, etc.) configured to allow the shaft 110 to travel therethrough. The carrier tube surrounds the shaft 110 such that the shaft 110 is configured to extend longitudinally through the carrier tube 160. The carrier tube 160 is connected or connectable to the handle 106. When the carrier tube 160 is connected to the handle 106, the carrier tube 160 is connected to the handle 106 by a luer lock connector, a lock connector, a fitting connector, or other suitable connection configuration. The carrier tube 160 may be a long carrier tube 180 (described in further detail herein) as shown in FIG. 1. In other embodiments, the carrier tube 160 may be a short carrier tube 182 (described in further detail herein). In some embodiments, the carrier tube 160 is configured to be attached to a guide catheter 184 (described in further detail herein).

[0095] The carrier tube 160 may be made of a fluoropolymer (e.g., polytetrafluoroethylene (PTFE), ethylene / tetrafluoroethylene copolymer (ETFE), polyetheretherketone (PEEK), polyurethane, polyamide elastomer, polyester elastomer, polyurethane elastomer, polyimide, polycarbonate, polyetherimide, tungsten, stainless steel, Ni-Ti, or other suitable material.

[0096] The carrier tube 160 has a length in the range of about 30-300 cm, for example, 30-200 cm.

[0097] The carrier tube 160 has a cross-sectional shape that is a circle, an ellipse, a polygon, a rounded polygon, or other geometric shape. The carrier tube 160 may have a maximum cross-sectional width (e.g., diameter when the cross-sectional shape is circular) in the range of about 1-15 mm, inclusive, e.g., 1-8 mm. The carrier tube 160 may have a wall with a thickness in the range of about 0.1-1 mm, inclusive.

[0098] In embodiments that include a carrier tube 160, when the balloon 130 and distal portion 140d of the drug tube 140 are located within the carrier tube 160, the distal portion 140d of the drug tube 140 is held by the carrier tube 160 in a deformed radially collapsed state, and when the balloon 130 and distal portion 140d of the drug tube 140 are located outside the carrier tube 160, the distal portion 140d of the drug tube 140 assumes a relaxed radially expanded state 144a. In these embodiments, the deformed state of the distal portion 140d of the drug tube 140 is a deformed radially collapsed state, and the distal portion 140d of the drug tube 140 is in a deformed state when located within the carrier tube 160. In these embodiments, the relaxed state of the distal portion 140d of the drug tube 140 is a relaxed radially expanded state 144a, and the distal portion 140d of the drug tube 140 can enter the relaxed radially expanded state 144a when the distal portion 140d of the drug tube 140 is located outside the carrier tube 160 and before, simultaneously with, or after the balloon 130 is inflated.

[0099] 8, the distal portion 140d of the drug tube 140 extends in a helical shape 140h when the drug tube distal portion 140d is in a deformed radially expanded state 144a or a relaxed radially expanded state 144a. In the helical shape 140h, the drug tube distal portion 140d has a shape that consists of a series of rotations along the drug tube distal portion 140d from the proximal end 130p of the balloon 130 to the distal end 130d of the balloon 130.

[0100] The turns of the helical shape 140h of the distal portion 140d of the drug tube 140 may be circular, elliptical, or have other rounded configurations. In Figures 2A, 2B, and 8, the turns of the helical shape 140h of the distal portion 140d of the drug tube 140 have the same spacing between each turn. However, in other embodiments, the turns of the helical shape 140h of the distal portion 140d of the drug tube 140 may have different spacing between each turn.

[0101] In the embodiment of FIG. 1, the distal portion 140d of the drug tube 140 meanders back and forth in a circumferential direction from the proximal end 130p of the balloon 130 to the distal end 130d of the balloon 130 when in the deformed radially expanded state 144a or the relaxed radially expanded state 144a. In FIG. 1, the distal portion 140d of the drug tube 140 is shown to make 12 turns as the distal portion 140d of the drug tube 140 meanders back and forth in a circumferential direction from the proximal end 130p of the balloon 130 to the distal end 130d of the balloon 130. However, in other embodiments, the distal portion 140d of the drug tube 140 may make any feasible number of turns as the distal portion 140d of the drug tube 140 meanders back and forth in a circumferential direction from the proximal end 130p of the balloon 130 to the distal end 130d of the balloon 130.

[0102] 1, the distal portion 140d of the drug tube 140 is shown as meandering back and forth circumferentially across a portion of the outside 130e of the balloon 130 in a direction from the proximal end 130p of the balloon 130 to the distal end 130d of the balloon 130. However, in other embodiments, the distal portion 140d of the drug tube 140 may meander back and forth circumferentially across the entire outside 130e of the balloon 130 in a direction from the proximal end 130p of the balloon 130 to the distal end 130d of the balloon 130.

[0103] 1, the distal portion 140d of the drug tube 140 is shown to have approximately similar axial lengths between turns of the distal portion 140d of the drug tube 140 as the distal portion 140d of the drug tube 140 meanders back and forth circumferentially in the direction from the proximal end 130p of the balloon 130 to the distal end 130d of the balloon 130. However, in other embodiments, the distal portion 140d of the drug tube 140 may have different axial lengths between turns of the distal portion 140d of the drug tube 140 as the distal portion 140d of the drug tube 140 meanders back and forth circumferentially in the direction from the proximal end 130p of the balloon 130 to the distal end 130d of the balloon 130.

[0104] In the embodiment of Figures 9A and 9B, the distal portion 140d of the drug tube 140 includes multiple branched drug tubes 146 distributed across the outside 130e of the balloon 130. The multiple branched drug tubes 146 may extend in any direction on the outside 130e of the balloon 130. The multiple branched drug tubes 146 branch off from the distal portion 140d of the drug tube 140, and the multiple branched drug tubes 146 may also branch off from one another. In Figure 9A, the multiple branched drug tubes 146 are shown as each having a substantially similar width. However, in other embodiments, the multiple branched drug tubes 146 may have a variety of widths. In Figure 9A, the multiple branched drug tubes 146 are shown as each having a substantially similar length. However, in other embodiments, the multiple branched drug tubes 146 may have a variety of lengths.

[0105] 9A and 9B, the multiple branched drug tubes 146 are disposed on a portion of the exterior 130e of the balloon 130. However, in other embodiments, the multiple branched drug tubes 146 may be disposed over the entire exterior 130e of the balloon 130.

[0106] 9A , each of the multiple branched drug tubes 146 has an end 148 that curls back on itself. Having the multiple branched drug tubes 146 have an end 148 that curls back on itself allows the end 148 to be less traumatic to the tube compared to multiple branched drug tubes 146 without an end 148 that curls back on itself.

[0107] In the embodiment of FIG. 9B, the branched drug tubes 146 have a lattice shape 140L. The branched drug tubes 146 are connected to each other such that the branched drug tubes 146 form a lattice shape 140L on the outside 130e of the balloon 130. When connected to each other to form the lattice shape 140L, the branched drug tubes 146 may extend in any direction on the outside 130e of the balloon 130. In FIG. 9B, the branched drug tubes 146 forming the lattice shape 140L are connected to each other at a substantially constant length. However, in other embodiments, the branched drug tubes 146 forming the lattice shape 140L may be connected to each other at various lengths. In FIG. 9B, the branched drug tubes 146 forming the lattice shape 140L have substantially similar lengths. However, in other embodiments, the branched drug tubes 146 forming the lattice shape 140L may have various lengths. In FIG. 9B, the branched drug tubes 146 forming the lattice shape 140L have a substantially straight shape. However, in other embodiments, the multiple branched drug tubes 146 forming the lattice configuration 140L may be curved or bent.

[0108] Second embodiment

[0109] 10A-11B show a drug eluting device 200 (e.g., a therapeutic device, etc.) for delivering a drug (e.g., sirolimus, etc.) into a vessel according to a second embodiment. The drug eluting device 200 includes a handle 206 including a drug port 204 configured to receive a drug. The drug eluting device 200 also includes a carrier tube 260 connected to the handle 206, the carrier tube 260 having a lumen 262. The drug eluting device 200 also includes a drug tube 240 configured to travel through the lumen 262 of the carrier tube 260. The drug tube 240 includes a proximal portion 240p configured to receive a drug from the drug port 204 and a distal portion 240d including a plurality of holes configured to allow the drug to exit the drug tube. When the distal portion 240d of the drug tube 240 is positioned within the carrier tube, the distal portion 240d of the drug tube 240 is held by the carrier tube 260 in a deformed, radially collapsed state. When the distal portion 240d of the drug tube 240 is outside the carrier tube 260, the distal portion 240d of the drug tube 240 assumes a relaxed radially expanded state 244a. In some embodiments, the handle 206 includes an actuator 208 configured to move the drug tube 240 relative to the carrier tube 260 or to move the carrier tube 260 relative to the drug tube 240. In some embodiments, the drug eluting device 200 may also include a radiopaque marker 270.

[0110] The drug eluting device 200 includes a handle 206 (e.g., a grip, hand grip, etc.). The handle 206 is configured similarly to the handle 106. The handle 206 includes a drug port 204 (e.g., a hole, an opening, an aperture, etc.) configured to receive a drug. The drug port 204 is configured similarly to the drug port 104. In other embodiments, the drug port 104 may be located on a proximal portion 240p of the drug tube 240.

[0111] In some embodiments, the handle 206 includes an actuator 208 (tab, button, wheel, knob, etc.). The actuator 208 is configured similarly to the actuator 108. In some embodiments, the actuator 208 is configured to move the medication tube 240 relative to the carrier tube 260. The medication tube 240 is aligned along a longitudinal axis A. L and / or the longitudinal axis A L In other embodiments, the actuator 208 is configured to move the carrier tube 260 relative to the drug tube 240. The carrier tube 260 may move longitudinally along a longitudinal axis A. L and / or a longitudinal axis A that can rotate clockwise or counterclockwise L .

[0112] The drug eluting device also includes a carrier tube 260 (e.g., a sheath, a guide sheath, a cover, etc.) configured to allow the drug tube 140 to travel therethrough. The carrier tube 260 is configured similarly to the carrier tube 160. The carrier tube 260 has a lumen 262 (e.g., a cavity, a space, etc.). The carrier tube 260 may be a long carrier tube 180, as shown in FIG. 10A. The carrier tube 260 is connected or connectable to the handle 206. When the carrier tube 260 is connected to the handle 206, the carrier tube 260 is connected to the handle 206 by a luer lock connector, a lock connector, a fitting connector, or other suitable connection configuration. In other embodiments, the carrier tube 260 may be a short carrier tube 182 (discussed in more detail herein). In some embodiments, the carrier tube 260 is configured to be attached to a guide catheter 184 (discussed in more detail herein).

[0113] The drug eluting device also includes a drug tube 240 (e.g., a pipe, a cylinder, a conduit, etc.). The drug tube 240 is configured similarly to the drug tube 140. The drug tube 240 is configured to travel through a lumen 262 of the carrier tube 260. At least a distal portion 240d of the drug tube 240 may be made of an elastically deformable material. In some embodiments, the drug tube 240 may be made of Nitinol or stainless steel.

[0114] The drug tube 240 has a proximal portion 240p and a distal portion 240d. The proximal portion 240p of the drug tube 240 is configured to receive the drug from the drug port 204.

[0115] The distal portion 240d of the drug tube 240 includes a plurality of holes 242 (e.g., apertures, openings, slits, etc.). The plurality of holes 242 is configured similarly to the plurality of holes 142. In some embodiments, the plurality of holes 242 is aligned along the longitudinal axis A of the carrier tube 260, as shown in FIG. 10A. L 4. The drug tube 240 is disposed radially outwardly in the direction RO with respect to the drug tube 240.

[0116] When the distal portion 240d of the drug tube 240 is located within the carrier tube 260, the distal portion 240d of the drug tube 240 is held by the carrier tube 260 in a deformed radially collapsed state, and when the distal portion 240d of the drug tube 240 is located outside the carrier tube 260, the distal portion 240d of the drug tube 240 assumes a relaxed radially expanded state 244a because the carrier tube 260 no longer applies an external force to the distal portion 240d of the drug tube 240. The deformed state is a state in which an external force is applied to the distal portion 240d of the drug tube 240. The relaxed state is a state in which no external force is applied to the distal portion 240d of the drug tube 240.

[0117] Drug-eluting device 200 may or may not use a guidewire, which may be configured similarly to guidewire 126.

[0118] 10A and 10B, when the distal portion 240d of the drug tube 240 is in a relaxed radially expanded state 244a, the distal portion 240d of the drug tube 240 extends in a helical shape 240h. In the helical shape 240h, the distal portion 240d of the drug tube 240 has a shape consisting of a series of turns along the distal portion 240d of the drug tube 240 from the proximal end 241p of the distal portion 240d of the drug tube 240 to the distal end 241d of the distal portion 240d of the drug tube 240.

[0119] The turns of the helical shape 240h of the distal portion 240d of the drug tube 240 may be circular, elliptical, or have other rounded arrangements. In Figures 10A and 10B, the turns of the helical shape 240h of the distal portion 240d of the drug tube 240 have the same spacing between each turn. However, in other embodiments, the turns of the helical shape 240h of the distal portion 240d of the drug tube 240 may have different spacing between each turn.

[0120] 11A and 11B, when the distal portion 240d of the drug tube 240 is in a relaxed radially expanded state 244a, the distal portion 240d of the drug tube 240 includes a plurality of drug tube segments 246. The plurality of drug tube segments 246 extend from a proximal end 241p of the distal portion 240d of the drug tube 240 to a distal end 241d of the distal portion 240d of the drug tube 240 and are aligned along a longitudinal axis A of the carrier tube 260. L11A and 11B, the plurality of drug tube segments 246 are shown to each have a substantially similar width. However, in other embodiments, the plurality of drug tube segments 246 may have a variety of widths. In FIG. 11A, the plurality of drug tube segments 246 are shown to have six drug tube segments. In FIG. 11B, the plurality of drug tube segments 246 are shown to have nine drug tube segments. In other embodiments, the plurality of drug tube segments 246 may have one, two, three, four, five, six, seven, eight, nine, or more drug tube segments.

[0121] In some embodiments, the drug eluting device may further include a radiopaque marker 270 (e.g., a hoop, band, disk, etc.). In Figures 10A and 10B, the radiopaque marker 270 is connected to the drug tube 240. The radiopaque marker 270 may be connected to the drug tube 240 by blading, swaging, press fitting, welding, or other suitable connection configuration. The radiopaque marker 270 has a maximum cross-sectional width in the range of about 1-15 mm (inclusive), e.g., 3-8 mm.

[0122] The radiopaque marker 270 may be made of gold, platinum, stainless steel, tungsten, tantalum, or other suitable material. The radiopaque marker 270 may be made of a radiopaque material. If the radiopaque marker 270 is made of a radiopaque material, the radiopaque marker 270 may be imaged using an imaging modality, such as x-ray, fluoroscopy, or other suitable imaging modality. The radiopaque material of the radiopaque marker 270 facilitates detection and tracking by imaging of the drug tube 240 when the drug tube 240 is inside the canal. Such detection and tracking of the radiopaque marker 270 allows for improved manipulation and positioning of the drug eluting device 200 within the canal, as well as improved targeting of the location of a portion of the canal, since a user may receive information of where the drug tube 240 is located through knowledge of the location of the radiopaque marker 270 by imaging.

[0123] 10B and 11B, the drug eluting device 200 has two radiopaque markers 270, one radiopaque marker 270 connected to the distal portion 240d of the drug tube 240 and another radiopaque marker 270 connected to the proximal portion of the drug tube 240. In other embodiments, the drug eluting device 200 may have one radiopaque marker 270. In some embodiments, the drug eluting device 200 with one radiopaque marker 270 may have the radiopaque marker 270 connected to the distal portion 240d of the drug tube 240. In other embodiments, the drug eluting device 200 with one radiopaque marker 270 may have the radiopaque marker 270 connected to the proximal portion 240p of the drug tube 240.

[0124] Typical operation of drug elution devices and long and short carrier tubes

[0125] 12A-14D show the drug eluting device in different configurations for operation of the drug eluting device. The drug eluting device may be used with a needle, a trocar, a guide catheter, a short carrier tube, a long carrier tube, an inserter, a valve, and / or a flushing device.

[0126] The drug eluting devices 100 and 200 may be used with a needle for insertion into a subject. The needle may be used to create a hole in the subject that provides access to a vessel. The vessel through which the needle provides access may be the vessel that is the target for drug elution or may be a vessel through which the drug eluting device can be pushed to reach another vessel that is the target for drug elution. In other embodiments, a trocar may be used to create a hole in the subject that provides access to a vessel.

[0127] After the needle provides access to the vessel, a guidewire, which may be guidewire 126, may be pushed through the needle and into the vessel to be positioned at or near the target for drug elution. Imaging may be used to facilitate positioning of the guidewire within the subject. The needle is then withdrawn from the subject, with the guidewire remaining within the subject. The guidewire is used to insert a portion of the drug eluting device 100 or 200 into the subject. The guidewire is then withdrawn from the vessel, with the components passed over it remaining within the vessel. In other embodiments, the guidewire may remain within the vessel, and the guidewire is withdrawn after the drug eluting device 100 or 200 has been used and withdrawn.

[0128] Drug eluting devices 100 and 200 may be used with a guide catheter 184 (e.g., a catheter, shaft, tube, pipe, cylinder, conduit, etc.). The guide catheter 184 is passed over a guidewire and inserted into the vessel. The guide catheter 184 may be positioned at or near the target for drug elution. In some embodiments, the shaft 110, balloon 130, drug tube 140, and / or carrier tube 160 may pass through the guide catheter 184. In other embodiments, the drug tube 240 and / or carrier tube 260 may pass through the guide catheter.

[0129] The use of guide catheter 184 allows balloon 130 and drug tube 140 or drug tube 240 to advance through the vessel without encountering calcification, plaque, or other material within the vessel that could impede the advancement of balloon 130 and drug tube 140 or drug tube 240 if encountered in the absence of guide catheter 184.

[0130] 12A-14D show a drug eluting device with a long carrier tube 180 (e.g., a sheath, a guide sheath, a cover, etc.) or a short carrier tube 182 (e.g., a sheath, a guide sheath, a cover, etc.). In some embodiments, the long carrier tube 180 can be a carrier tube 160 having a length equal to or greater than the length of the shaft 110. In other embodiments, the long carrier tube 180 can be a carrier tube 260 having a length equal to or greater than the axial length 250 of the drug tube 240. The axial length 250 of the drug tube 240 is measured along the longitudinal axis A as in FIG. L In some embodiments, the short carrier tube 182 may be a carrier tube 160 having a length approximately equal to the axial length 151 of the distal portion 140d of the drug tube 140, in the range of about 100-120%, preferably 110%, of the axial length of the distal portion 140d of the drug tube 140. The axial length 151 of the distal portion 140d of the drug tube 140 is measured along the longitudinal axis A as in FIG. LIn other embodiments, the short carrier tube 182 may be a carrier tube 260 having a length approximately equal to the axial length 251 of the distal portion 240d of the drug tube 240, in the range of about 100-120%, preferably 110%, of the axial length of the distal portion 240d of the drug tube 240. The axial length 251 of the distal portion 240d of the drug tube 240 is measured along the longitudinal axis A as shown in FIG. L The long carrier tube 180 and the short carrier tube 182 may be used in conjunction with a guide catheter 184.

[0131] 12A-12D show a drug eluting device with a short carrier tube 182 and a guide catheter 184. The short carrier tube 182 may be connected to the guide catheter 184 such that the shaft 110 or drug tube 240 may first pass through the short carrier tube 182 and then through the guide catheter 184. The short carrier tube 182 may be connected to the guide catheter 184 by a snap fit, a luer lock connector, or other suitable connection configuration. The short carrier tube 182 may be connected to a handle, which may be the handle 106 or the handle 206, by a luer lock connector, a lock connector, a fitting connector, or other suitable connection configuration. In the configuration of FIG. 12A, the short carrier tube 182 is not connected to the handle 106. In the configuration of FIGS. 12B-12D, the short carrier tube 182 is connected to the handle 106.

[0132] The use of a short carrier tube 182 and guide catheter 184 allows for protection of the balloon 130 during insertion of the balloon 130 and allows the balloon 130 to be primed and then inserted directly into the guide catheter 184, which eliminates the introduction of air into the guide catheter 184. The use of a short carrier tube 182 facilitates transfer of the balloon 130 into the guide catheter 184.

[0133] 12A-12D, a short carrier tube 182 is shown with the drug-eluting device 100. In FIG. 12A, the balloon 130 and drug tube 140 are disposed within the short carrier tube 182. In FIG. 12B, the balloon 130 and drug tube 140 are pushed through the short carrier tube 182 and into the guide catheter 184. In some embodiments in which the drug-eluting device 100 includes a balloon 130 and the relaxed state of the distal portion 140d of the drug tube 140 is the radially expanded state 144a, when the balloon 130 and the distal portion 140d of the drug tube 140 are pushed outside the guide catheter 184, the distal portion 140d of the drug tube 140 is partially expanded and the balloon 130 is partially inflated, similar to the shape of the balloon 130 in FIG. In Fig. 12C, the balloon 130 and drug tube 140 are pushed forward such that the distal portion 140d of the balloon 130 and drug tube 140 is completely outside the guide catheter 184. In Fig. 12C, the balloon 130 is inflated and the distal portion 140d of the drug tube 140 is in a deformed radially expanded state 144a or a relaxed radially expanded state 144a. In Fig. 12D, the balloon 130 and drug tube 140 are pulled back such that the distal portion 140d of the balloon 130 and drug tube 140 is partially inside the guide catheter 184. After the drug is delivered, the distal portion 140d of the balloon 130 and drug tube 140 can be pulled back such that the distal portion 140d of the balloon 130 and drug tube 140 is inside the guide catheter 184 as in Fig. 12B or within the short carrier tube 182 as in Fig. 12A.

[0134] In other embodiments, the short carrier tube 182 of Figures 12A-12D may be used with a drug eluting device 200. Figures 12A-12D show an over-the-wire type device. In other embodiments, the short carrier tube 182 of Figures 12A-12D may be used with a rapid exchange type device. When the short carrier tube 182 is used with a rapid exchange type device and a guide catheter 184, the guidewire 126 is positioned inside the guide catheter 184 along the shaft 110.

[0135] In Figures 13A-13C, a long carrier tube 180 is shown with the drug-eluting device 100. The long carrier tube 180 connects to a handle, which may be the handle 106 or the handle 206, and is connected by a luer lock connector, a lock connector, a fitting connector, or other suitable connection configuration. In Figure 13A, the balloon 130 and the drug tube 140 are disposed within the long carrier tube 180. In some embodiments in which the drug-eluting device 100 includes a balloon 130 and the relaxed state of the distal portion 140d of the drug tube 140 is the radially expanded state 144a, when the balloon 130 and the distal portion 140d of the drug tube 140 are pushed out of the long carrier tube 180, the distal portion 140d of the drug tube 140 is partially expanded and the balloon 130 is partially inflated, similar to the shape of the balloon 130 in Figure 13C. In Fig. 13B, the balloon 130 and drug tube 140 are pushed forward such that the distal portion 140d of the balloon 130 and drug tube 140 is completely outside the long carrier tube 180. In Fig. 13B, the balloon 130 is inflated and the distal portion 140d of the drug tube 140 is in a deformed radially expanded state 144a or a relaxed radially expanded state 144a. In Fig. 13C, the balloon 130 and drug tube 140 are pulled back such that the distal portion of the balloon 130 and drug tube 140 is partially inside the long carrier tube 180. After the drug is delivered, the distal portion 140d of the balloon 130 and drug tube 140 can be pulled back such that the distal portion 140d of the balloon 130 and drug tube 140 is inside the long carrier tube 180 as in Fig. 13A.

[0136] In other embodiments, the long carrier tube 180 of Figures 13A-13C may be used with the drug eluting device 200. In some embodiments, the long carrier tube 180 of Figures 13A-13C may be used with the guide catheter 184 of Figures 12A-12D in place of the short carrier tube 182. Figures 13A-13C show an over-the-wire type device. In other embodiments, the long carrier tube 180 of Figures 13A-13C may be used with a rapid exchange type device. When the long carrier tube 180 is used with a rapid exchange type device and guide catheter 184, the guidewire 126 is positioned inside the guide catheter 184 along the shaft 110.

[0137] 14A-14D show a drug eluting device that includes a guide catheter 184, an inserter 186 (e.g., a shaft, tube, pipe, cylinder, conduit, etc.), a valve 188 (e.g., a connection, gate, tap, etc.), and a flushing device 189. Guide catheter 184 may be connected to inserter 186 by a luer lock connector or other suitable connection configuration.

[0138] The inserter 186 may be connected to the valve 188 by a luer lock connector or other suitable connection configuration. The inserter 186 may pass over a guidewire. Using the inserter 186 to provide the balloon 130 to the guide catheter 184 may make it easier to push the balloon 130 within the guide catheter 184, because without the inserter 186, the balloon 130 may buckle when pushed, or pushing the balloon 130 may introduce air into the guide catheter 184.

[0139] 14C and 14D, valve 188 is a three-way valve configured to connect to inserter 186, connect to flushing device 189, and receive a portion of drug-eluting device 100 or drug-eluting device 200. In other embodiments, valve 188 may be a two-way valve configured to connect to inserter 186 and receive a portion of drug-eluting device 100 or drug-eluting device 200. Valve 188 may pass over a guidewire.

[0140] The flushing device 189 may be used to flush the introducer 186 and / or the guide catheter 184, thereby deflating the introducer 186, which allows for easy and safe transfer of the balloon 130 into the guide catheter 184 without air.

[0141] In Figures 14A-14D, the guide catheter 184, the inserter 186, and the valve 188 are shown with a portion of the drug-eluting device 100. In Figure 14A, the shaft 110 is pulled through the inserter 186. In Figure 14B, the shaft 110 is pulled through the inserter 186 such that the balloon 130 is within the inserter 186. In Figure 14C, the shaft 110 is pulled such that it passes through the valve 188. In Figure 14C, the inserter 186 is shown connected to the guide catheter 184 and also connected to the valve 188. Before or after use of the inserter 186, the guide catheter 184, and the valve 188, the inserter 186 may be unconnected to the guide catheter 184 and unconnected to the valve 188. The inserter 186 may be connected to the guide catheter 184 by a luer lock connector or by other suitable connection configuration. The inserter 186 may be connected to the valve 188 by a Luer lock connector or by other suitable connection configuration. In FIG.

[0142] In other embodiments, the guide catheter 184, the inserter 186, the valve 188, and / or the flushing device 189 in Figures 14A-14D may be used with a drug eluting device 200. In other embodiments, the inserter 186, the valve 188, and / or the flushing device 189 in Figures 14A-14D may be used with a long carrier tube 180 or a short carrier tube 182. In some embodiments, the inserter 186, the valve 188, and / or the flushing device 189 may be used with a rapid exchange type device. In other embodiments, the inserter 186, the valve 188, and / or the flushing device 189 may be used with an over-the-wire type device.

[0143] Methods for drug delivery using drug eluting devices

[0144] An exemplary first method for delivering an agent into a vessel includes providing a drug-eluting device 100. The first method also includes inserting a distal portion 110d of a shaft 110 into the vessel. The first method also includes inflating a balloon 130 by providing an inflation fluid to the balloon 130 via a balloon inflation tube 112, which causes a distal portion 140d of the agent tube 140 to assume a deformed radially expanded state 144a. The first method also includes delivering an agent into the vessel via the agent tube 140 and a plurality of holes 142 in the agent tube 140.

[0145] The first method includes providing a drug eluting device 100. The drug eluting device 100 includes a handle 106 including a balloon inflation port 102 configured to receive an inflation fluid and a drug port 104 configured to receive a drug. The drug eluting device 100 also includes a shaft 110 connected to the handle 106. The shaft 110 includes a balloon inflation lumen 113 configured to receive an inflation fluid from the balloon inflation port 102, a drug lumen 114 configured to receive a drug from the drug port 104, and a guidewire lumen 117 configured to receive a guidewire 126 and allow the guidewire 126 to extend out of a distal portion 110d of the shaft 110. The drug eluting device 100 also includes a balloon 130 attached to the distal portion 110d of the shaft 110 and configured to receive an inflation fluid from the balloon inflation lumen 113. The drug eluting device 100 also includes a drug tube 140 defining a distal portion 114d of the drug lumen 114, the drug tube 140 having a distal portion 140d connected to the exterior 130e of the balloon 130 and including a plurality of holes 142 configured to allow the drug to exit the drug tube 140. In some embodiments, the drug eluting device 100 may further include a guidewire tube 116 having a guidewire lumen 117 formed therein. In some embodiments, the drug eluting device 100 may further include a balloon inflation tube 112 having a balloon inflation lumen 113 formed therein. Although the first method is described with respect to the drug eluting device 100, it should be understood that the operation of the first method is equally applicable to any other device including components similar to those described herein.

[0146] The first method includes inserting the distal portion 110d of the shaft 110 into the vessel such that the distal portion 110d of the shaft 110 is at a location within the vessel that is the target for drug elution. Inserting the distal portion 110d of the shaft 110 into the vessel may include using a needle, a trocar, a guide catheter 184 as in Figures 12A-12D, an inserter 186 as in Figures 14A-14D, a valve 188 as in Figures 14A-14D, and / or a flushing device 189 as in Figures 14A-14D.

[0147] The first method involves inflating the balloon 130 by supplying inflation fluid to the balloon 130 via the balloon inflation tube 112, which causes the distal portion 140d of the drug tube 140 to assume a deformed, radially expanded state 144a, as in Figures 1, 2A, 2B, 8 or 9A. Pressure on the inflated balloon 130 is maintained by the drug entering the balloon 130, which maintains the distal portion 140d of the drug tube 140 in its deformed, radially expanded state 144a.

[0148] The first method involves delivering a drug into the vessel through drug tube 140 and a number of holes 142 in drug tube 140. Drug is provided to drug tube 140 through drug port 104.

[0149] A second exemplary method of delivering a drug into a vessel includes providing a drug-eluting device 100 using a long carrier tube 180 as the carrier tube 160. The second method also includes inserting a distal portion 110d of the shaft 110 into the vessel. The second method also includes pushing the shaft 110 or pulling the carrier tube 160 such that the distal portion 140d of the drug tube 140 and the balloon 130 are outside the carrier tube 160, which causes the distal portion 140d of the drug tube 140 to assume a relaxed radially expanded state 144a. The second method also includes inflating the balloon 130 by providing an inflation fluid to the balloon 130 via the balloon inflation tube 112. The second method also includes delivering a drug into the vessel through the drug tube 140 and a plurality of holes 142 in the drug tube 140.

[0150] The second method includes providing a drug eluting device 100. The drug eluting device includes a handle 106 including a balloon inflation port 102 configured to receive an inflation fluid and a drug port 104 configured to receive a drug. The drug eluting device 100 also includes a shaft 110 connected to the handle 106. The shaft 110 includes a balloon inflation lumen 113 configured to receive an inflation fluid from the balloon inflation port 102, a drug lumen 114 configured to receive a drug from the drug port 104, and a guidewire lumen 117 configured to receive a guidewire 126 and allow the guidewire 126 to extend out of a distal portion 110d of the shaft 110. The drug eluting device 100 also includes a balloon 130 attached to the distal portion 110d of the shaft 110 and configured to receive an inflation fluid from the balloon inflation lumen 113. The drug eluting device 100 also includes a carrier tube 160 connected to the handle 106, the carrier tube configured to allow the shaft 110 to travel therethrough. The carrier tube 160 has a length equal to or greater than the length of the shaft 110. The drug eluting device 100 also includes a drug tube defining a distal portion of a drug lumen, the drug tube having a distal portion 140d connected to the exterior 130e of the balloon 130 and including a plurality of holes 142 configured to allow drug to exit the drug tube 140. In some embodiments, the handle 106 includes an actuator 108 configured to move the shaft 110 relative to the carrier tube 160 or to move the carrier tube 160 relative to the shaft 110. In some embodiments, the drug eluting device 100 may further include a guidewire tube 116 having a guidewire lumen 117 formed therein. In some embodiments, the drug eluting device 100 may further include a balloon inflation tube 112 having a balloon inflation lumen 113 formed therein. Although the second method is described with respect to the drug eluting device 100, it should be understood that the operation of the second method is equally applicable to any other device including components similar to those described herein.

[0151] The second method includes inserting the distal portion 110d of the shaft 110 into the blood vessel such that the distal portion 110d of the shaft 110 is at a location within the vessel that is the target for drug elution. Inserting the distal portion 110d of the shaft 110 into the vessel may include using a needle, a trocar, a guide catheter 184 as in Figures 12A-12D, an inserter 186 as in Figures 14A-14D, a valve 188 as in Figures 14A-14D, and / or a flushing device 189 as in Figures 14A-14D.

[0152] The second method includes pushing the shaft 110 or pulling the carrier tube 160 so that the distal portion 140d of the drug tube 140 and the balloon 130 are outside the carrier tube 160, which causes the distal portion 140d of the drug tube 140 to assume a relaxed radially expanded state 144a as in FIG. 1, 2A, 2B, 8, or 9A. In some embodiments, the actuator 108 of the handle 106 can be used to push the shaft 110 or pull the carrier tube 160. The carrier tube 160 holds the distal portion 140d of the drug tube 140 in a deformed radially compressed state as in FIG. 12A or 13A, and removing the carrier tube 160 surrounding the distal portion 140d of the drug tube 140 allows the distal portion 140d of the drug tube 140 to enter a relaxed radially expanded state 144a as in FIG. 12D or 13C.

[0153] The second method involves inflating the balloon 130 by supplying an inflation fluid to the balloon 130 through the balloon inflation tube 112. The balloon 130 may be inflated before, at the same time as, or after the distal portion 140d of the drug tube 140 is in a relaxed radially expanded state 144a. The second method involves delivering a drug into the vessel through the drug tube 140 and a number of holes 142 in the drug tube 140. The drug is supplied to the drug tube 140 through the drug port 104.

[0154] In some embodiments, the second method includes inserting a guide catheter 184 into the vessel prior to inserting the distal portion 110d of the shaft 110 into the vessel. The carrier tube 160 is connected to the guide catheter 184. In the step of inserting the distal portion 110d of the shaft 110 into the vessel, the distal portion 110d of the shaft 110 is inserted into the guide catheter 184. In the step of pushing the shaft 110 or pulling the carrier tube 160, the shaft 110 is pushed such that the distal portion 140d of the drug tube 140 and the balloon 130 are outside the guide catheter 184.

[0155] An exemplary third method for delivering a drug into a vessel includes providing a drug-eluting device 100 using a short carrier tube 182 as the carrier tube 160. The third method also includes inserting a distal portion 110d of the shaft 110, the carrier tube 160, and a guide catheter 184 into the vessel. The third method also includes pushing the shaft 110 such that the distal portion 140d of the drug tube 140 and the balloon 130 are outside the carrier tube 160 and the guide catheter 184, which causes the distal portion 140d of the drug tube 140 to assume a relaxed radially expanded state 144a. The third method also includes inflating the balloon 130 by providing an inflation fluid to the balloon 130 via the balloon inflation tube 112. The third method also includes delivering a drug into the vessel through the drug tube 140 and a plurality of holes 142 in the drug tube 140.

[0156] The third method includes providing a drug eluting device 100. The drug eluting device includes a handle 106 including a balloon inflation port 102 configured to receive an inflation fluid and a drug port 104 configured to receive a drug. The drug eluting device 100 also includes a shaft 110 connected to the handle 106. The shaft 110 includes a balloon inflation lumen 113 configured to receive an inflation fluid from the balloon inflation port 102, a drug lumen 114 configured to receive a drug from the drug port 104, and a guidewire lumen 117 configured to receive a guidewire 126 and allow the guidewire 126 to extend out of a distal portion 110d of the shaft 110. The drug eluting device 100 also includes a balloon 130 attached to the distal portion 110d of the shaft 110 and configured to receive an inflation fluid from the balloon inflation lumen 113. The drug eluting device 100 also includes a carrier tube 160 connected or connectable to the handle 106, the carrier tube 160 configured to allow the shaft 110 to travel therethrough. The carrier tube 160 is configured to be attached to the guide catheter 184. The drug eluting device 100 also includes a drug tube defining a distal portion of a drug lumen, the drug tube having a distal portion 140d connected to the exterior 130e of the balloon 130 and including a plurality of holes 142 configured to allow drug to exit the drug tube 140. The carrier tube 160 has a length approximately equal to an axial length of the distal portion 140d of the drug tube 140. In some embodiments, the handle 106 includes an actuator 108 configured to move the shaft 110 relative to the carrier tube 160 or to move the carrier tube 160 relative to the shaft 110. In some embodiments, the drug eluting device 100 may further include a guidewire tube 116 having a guidewire lumen 117 formed therein. In some embodiments, the drug eluting device 100 may further include a balloon inflation tube 112 having a balloon inflation lumen 113 formed therein.Although the third method is described with respect to drug-eluting device 100, it should be understood that the operations of the third method are equally applicable to any other device containing components similar to those described herein.

[0157] A third method includes inserting the distal portion 110d of shaft 110, carrier tube 160, and guide catheter 184 into the vessel such that the distal portion 110d of shaft 110 is at a location within the vessel that is the target for drug elution. Inserting the distal portion 110d of shaft 110 into the vessel may include using a needle, a trocar, an inserter 186 as in FIGS. 14A-14D, a valve 188 as in FIGS. 14A-14D, and / or a flushing device 189 as in FIGS. 14A-14D.

[0158] A third method includes pushing the shaft 110 such that the distal portion 140d of the drug tube 140 and the balloon 130 are outside the carrier tube 160 and the guide catheter 184, which causes the distal portion 140d of the drug tube 140 to assume a relaxed radially expanded state 144a, as in FIG. 1, FIG. 2A, FIG. 2B, FIG. 8, or FIG. 9A. In some embodiments, the actuator 108 of the handle 106 can be used to push the shaft 110. The carrier tube 160 or the guide catheter 184 holds the distal portion 140d of the drug tube 140 in a deformed radially compressed state, as in FIG. 12A or FIG. 13A, and removing the carrier tube 160 or the guide catheter 184 surrounding the distal portion 140d of the drug tube 140 allows the distal portion 140d of the drug tube 140 to enter the relaxed radially expanded state 144a, as in FIG. 12D or FIG. 13C.

[0159] A third method involves inflating the balloon 130 by supplying an inflation fluid to the balloon 130 via the balloon inflation tube 112. The balloon 130 may be inflated before, simultaneously with, or after the distal portion 140d of the drug tube 140 assumes the relaxed radially expanded state 144a.

[0160] The third method involves supplying the drug into the vessel through drug tube 140 and a number of holes 142 in drug tube 140. Drug is supplied to drug tube 140 through drug port 104.

[0161] An example of a fourth method of delivering a drug into a vessel includes providing a drug eluting device 200 using a long carrier tube 180 as the carrier tube 260. The fourth method also includes inserting a distal portion 260d of the carrier tube 260 into the vessel. The fourth method also includes pushing or pulling the drug tube 240 such that the distal portion 240d of the drug tube 240 is outside the carrier tube 260, which causes the distal portion 240d of the drug tube 240 to assume a relaxed radially expanded state 244a, and the drug tube 240 receives the drug from the drug port 204. The fourth method also includes delivering a drug into the vessel through the drug tube 240 and a plurality of holes 242 in the drug tube 240.

[0162] The fourth method includes providing a drug eluting device 200. The drug eluting device includes a handle 206 including a drug port 204 configured to receive a drug. The drug eluting device 200 also includes a carrier tube 260 connected to the handle 206, the carrier tube 260 having a lumen 262. The drug eluting device 200 also includes a drug tube 240 configured to travel through the lumen 262 of the carrier tube 260. The drug tube 240 includes a proximal portion 240p configured to receive a drug from the drug port 204 and a distal portion 240d including a plurality of holes configured to allow the drug to exit the drug tube. When the distal portion 240d of the drug tube 240 is positioned within the carrier tube, the distal portion 240d of the drug tube 240 is held by the carrier tube 260 in a deformed, radially collapsed state. When the distal portion 240d of the drug tube 240 is outside the carrier tube 260, the distal portion 240d of the drug tube 240 assumes a relaxed radially expanded state 244a. The carrier tube 260 has a length equal to or greater than the axial length of the drug tube 240. In some embodiments, the handle 206 includes an actuator 208 configured to move the drug tube 240 relative to the carrier tube 260 or to move the carrier tube 260 relative to the drug tube 240. In some embodiments, the drug eluting device 200 may further include a radiopaque marker 270. Although the fourth method is described with respect to the drug eluting device 200, it should be understood that the operation of the fourth method is equally applicable to any other device including components similar to those described herein.

[0163] A fourth method includes inserting the distal portion 260d of the carrier tube 260 into the vessel such that the distal portion 260d of the carrier tube 260 is at a location within the vessel that is the target for drug elution. Inserting the distal portion 260d of the carrier tube 260 into the vessel may include using a needle, a trocar, a guide catheter 184 as in Figures 12A-12D, an inserter 186 as in Figures 14A-14D, a valve 188 as in Figures 14A-14D, and / or a flushing device 189 as in Figures 14A-14D.

[0164] A fourth method includes pushing the drug tube 240 or pulling the carrier tube 260 such that the distal portion 240d of the drug tube 240 is outside the carrier tube 260, which causes the distal portion 240d of the drug tube 240 to assume a relaxed radially expanded state 244a, as shown in FIG. 10A, FIG. 10B, FIG. 11A, or FIG. 11B. In some embodiments, the actuator 208 of the handle 206 can be used to push the shaft 210 or pull the carrier tube 260. When the carrier tube 260 surrounds the distal portion 240d of the drug tube 240, the carrier tube 260 holds the distal portion 240d of the drug tube 240 in a deformed radially compressed state, and removing the carrier tube 260 surrounding the distal portion 240d of the drug tube 240 allows the distal portion 240d of the drug tube 240 to enter the relaxed radially expanded state 244a.

[0165] The fourth method involves delivering the drug into the vessel via a drug tube 240 and a number of holes 242. The drug is provided to the drug tube 240 via the drug port 204.

[0166] In some embodiments, the second method includes inserting the guide catheter 184 into the vessel before inserting the distal portion 110d of the shaft 110 into the vessel. The carrier tube 160 is connected to the guide catheter 184. In the step of inserting the distal portion 110d of the shaft 110 into the vessel, the distal portion 110d of the shaft 110 is inserted into the guide catheter 184. In the step of pushing the shaft 110 or pulling the carrier tube 160, the shaft 110 is pushed such that the distal portion 140d of the drug tube 140 and the balloon 130 are outside the guide catheter 184.

[0167] A fifth exemplary method of delivering an agent into a vessel includes providing the agent-eluting device 200 using a short length of carrier tube 182 as the carrier tube 260. The fifth method also includes inserting a distal portion 260d of the carrier tube 260 and a guide catheter 184 into the vessel. The fifth method also includes pushing the agent tube 240 such that the distal portion 240d of the agent tube 240 is outside the carrier tube 260 and the guide catheter 184, which causes the distal portion 240d of the agent tube 240 to assume a relaxed radially expanded state 244a, and the agent tube 240 receives the agent from the agent port 204. The fifth method also includes delivering an agent into the vessel through the agent tube 240 and a plurality of holes 242 in the agent tube 240.

[0168] The fifth method includes providing a drug eluting device 200. The drug eluting device includes a handle 206 including a drug port 204 configured to receive a drug. The drug eluting device 200 also includes a carrier tube 260, which is connected or connectable to the handle 206. The carrier tube 260 has a lumen 262. The carrier tube 260 is configured to be attached to a guide catheter 184. The drug eluting device 200 also includes a drug tube 240 configured to travel through the lumen 262 of the carrier tube 260. The drug tube 240 includes a proximal portion 240p configured to receive a drug from the drug port 204 and a distal portion 240d including a plurality of holes configured to allow the drug to exit the drug tube. When the distal portion 240d of the drug tube 240 is positioned within the carrier tube, the distal portion 240d of the drug tube 240 is held by the carrier tube 260 in a deformed, radially collapsed state. When the distal portion 240d of the drug tube 240 is outside the carrier tube 260, the distal portion 240d of the drug tube 240 assumes a relaxed radially expanded state 244a. The carrier tube 260 has a length approximately equal to an axial length of the distal portion 240d of the drug tube 240. In some embodiments, the handle 206 has an actuator 208 configured to move the drug tube 240 relative to the carrier tube 260 or to move the carrier tube 260 relative to the drug tube 240. In some embodiments, the drug eluting device 200 may further include a radiopaque marker 270. Although the fifth method is described with respect to the drug eluting device 200, it should be understood that the operation of the fifth method is equally applicable to any other device including components similar to those described therein.

[0169] A fifth method includes inserting the distal portion 260d of the carrier tube 260 and the guide catheter 184 into the vessel such that the distal portion 184d of the guide catheter 184 is at a location within the vessel that is the target for drug elution. Inserting the distal portion 260d of the carrier tube 260 and the guide catheter 184 into the vessel may include using a needle, a trocar, an inserter 186 as in FIGS. 14A-14D , a valve 188 as in FIGS. 14A-14D , and / or a flushing device 189 as in FIGS. 14A-14D .

[0170] A fifth method includes pushing the drug tube 240 such that the distal portion 240d of the drug tube 240 is outside of the carrier tube 260 and the guide catheter 184, which causes the distal portion 240d of the drug tube 240 to assume a relaxed radially expanded state 244a, as in Figures 10A, 10B, 11A or 11B. In some embodiments, the actuator 208 of the handle 206 can be used to push the shaft 210. When the carrier tube 260 or guide catheter 184 surrounds the distal portion 240d of the drug tube 240, the carrier tube 260 or guide catheter 184 holds the distal portion 240d of the drug tube 240 in a deformed radially compressed state, and removing the carrier tube 260 or guide catheter 184 surrounding the distal portion 240d of the drug tube 240 allows the distal portion 240d of the drug tube 240 to enter a relaxed radially expanded state 244a.

[0171] The fifth method involves delivering the drug into the vessel through drug tube 240 and a number of holes 242. The drug is provided to drug tube 240 through drug port 204.

[0172] Configuration of an Exemplary Embodiment

[0173] It should be noted that the term "example" as used herein to describe various embodiments is intended to indicate that such embodiments are possible examples, representations, and / or illustrations of possible embodiments (and such terms do not necessarily imply that such embodiments are particular or top-tier examples).

[0174] As used herein, the term "coupled" or the like means to join two members directly or indirectly to one another. Such a joining may be static (e.g., permanent) or movable (e.g., removable or releasable). Such joining may be achieved by the two members or the two members and any additional intermediate members being integrally formed with one another as a single unitary body, or by the two members or the two members and any additional intermediate members being attached to one another.

[0175] It is important to note that the configurations and arrangements of the various exemplary embodiments are merely illustrative. Although only a few embodiments are described in detail in this disclosure, those skilled in the art who review this disclosure will readily appreciate that many modifications are possible without substantially departing from the novel teachings and advantages of the subject matter described herein (e.g., variations in size, dimensions, structure, shape and proportions of various elements, parameter values, mounting arrangements, use of materials, colors, orientations, etc.). Furthermore, it should be understood that features of one embodiment disclosed herein can be combined with features of other embodiments disclosed herein, as would be understood by one skilled in the art. Other substitutions, modifications, changes, and omissions can also be made in the design, operating conditions, and arrangements of the various exemplary embodiments without departing from the scope of the present invention.

[0176] Although the present specification contains many specific implementation details, these should not be construed as a limitation on the scope of any invention or what may be claimed, but rather as a description of features specific to particular implementations of a particular invention. Certain features described in the present specification in the context of a separate implementation may also be implemented in combination in a single implementation. Conversely, various features described in the context of a single implementation may also be implemented separately in multiple implementations or in any suitable subcombination. Furthermore, although features may be described above as acting in a particular combination and initially claimed as such, one or more features from a claimed combination may, in some cases, be removed from the combination, and the claimed combination may be directed to a subcombination or a variation of the subcombination.

[0177] As used herein, the terms "substantially," "generally," "approximately," and similar terms are intended to have a broad meaning consistent with common and accepted usage by those of ordinary skill in the art to which the subject matter of this disclosure pertains. Those of ordinary skill in the art who review this disclosure should understand that these terms are intended to enable the description of the particular features described and claimed without limiting the scope of those features to the precise numerical ranges provided. These terms should therefore be interpreted as indicating that insubstantial or insignificant modifications or variations of the subject matter described and claimed are believed to be within the scope of the appended claims.

[0178] Also, the term "or" is used in its inclusive (and not exclusive) sense in the context of lists of elements, so that when used to connect a list of elements, the term "or" means one, some, or all of the elements in the list. Unless otherwise indicated, conjunctions such as the phrase "at least one of X, Y, and Z" are understood in the context in which they are otherwise commonly used to convey that an item, term, etc. can be either X, Y, Z, X and Y, X and Z, Y and Z, or X, Y, and Z (i.e., any combination of X, Y, and Z). Thus, such conjunctions are not generally intended to mean that a particular embodiment requires that at least one of X, at least one of Y, and at least one of Z, respectively, be present, unless otherwise indicated.

[0179] Additionally, the use of ranges of values ​​herein (e.g., W1 to W2, etc.) includes their maximum and minimum values ​​(e.g., W1 to W2 includes W1 and includes W2, etc.) unless otherwise indicated. Additionally, ranges of values ​​(e.g., W1 to W2, etc.) do not necessarily require inclusion of intermediate values ​​within the range of values ​​(e.g., W1 to W2 may include only W1 and W2, etc.) unless otherwise indicated.

Claims

1. A handle comprising: a balloon inflation port configured to receive an inflation fluid; and a medication port configured to receive a medication; a handle having A shaft connected to the handle: a balloon inflation lumen configured to receive the inflation fluid from the balloon inflation port; a medication lumen configured to receive the medication from the medication port; and a guidewire lumen configured to receive a guidewire and allow the guidewire to extend out of the distal portion of the shaft; a shaft having a balloon attached to the distal portion of the shaft and configured to receive the inflation fluid from the balloon inflation lumen; and a drug tube defining a distal portion of the drug lumen, the drug tube having a distal portion connected to an exterior of the balloon and having a plurality of holes configured to allow the drug to exit the drug tube; A drug elution device comprising:

2. At least the distal portion of the drug tube is made of an elastically deformable material.

2. The drug eluting device of claim 1.

3. further comprising a carrier tube connected or connectable to the handle, the carrier tube configured to allow the shaft to move through the carrier tube; when the balloon and the distal portion of the drug tube are located within the carrier tube, the distal portion of the drug tube is held in a deformed radially folded state by the carrier tube, and when the balloon and the distal portion of the drug tube are located outside the carrier tube, the distal portion of the drug tube assumes a relaxed radially expanded state.

3. The drug eluting device of claim 2.

4. the handle has an actuator configured to move the shaft relative to the carrier tube or move the carrier tube relative to the shaft; 4. The drug eluting device of claim 3.

5. The carrier tube is configured to be attached to a guide catheter.

4. The drug eluting device of claim 3.

6. before the balloon is inflated, the distal portion of the drug tube is in a relaxed, radially collapsed state, and when the balloon is inflated with the inflation fluid, the distal portion of the drug tube is expanded by the balloon to a deformed, radially expanded state.

3. The drug eluting device of claim 2.

7. when the distal portion of the drug tube is in the relaxed radially expanded state, the distal portion of the drug tube extends in a helical configuration.

4. The drug eluting device of claim 3.

8. when the distal portion of the drug tube is in the deformed radially expanded state, the distal portion of the drug tube extends in a helical configuration.

7. The drug eluting device of claim 6.

9. when the distal portion of the drug tube is in the deformed radially expanded state, the distal portion of the drug tube meanders back and forth circumferentially in a direction from the proximal end of the balloon to the distal end of the balloon.

4. The drug eluting device of claim 3.

10. when the distal portion of the drug tube is in the deformed radially expanded state, the distal portion of the drug tube meanders back and forth circumferentially in a direction from the proximal end of the balloon to the distal end of the balloon.

7. The drug eluting device of claim 6.

11. the distal portion of the drug tube having a plurality of branched drug tubes distributed around the exterior of the balloon when the distal portion of the drug tube is in the deformed radially expanded state.

4. The drug eluting device of claim 3.

12. the distal portion of the drug tube having a plurality of branched drug tubes distributed around the exterior of the balloon when the distal portion of the drug tube is in the deformed radially expanded state.

7. The drug eluting device of claim 6.

13. each of the branched drug tubes having an end that recoils back onto itself; 12. The drug eluting device of claim 11.

14. each of the branched drug tubes having an end that recoils back onto itself; 13. The drug eluting device of claim 12.

15. when the distal portion of the drug tube is in the relaxed radially expanded state, the distal portion of the drug tube has a lattice shape.

4. The drug eluting device of claim 3.

16. when the distal portion of the drug tube is in the deformed radially expanded state, the distal portion of the drug tube has a lattice shape.

7. The drug eluting device of claim 6.

17. The drug tube is made of Nitinol or stainless steel.

3. The drug eluting device of claim 2.

18. the balloon inflation lumen, the drug lumen, and the guidewire lumen are separate from one another; 2. The drug eluting device of claim 1.

19. the drug lumen extends through the balloon inflation lumen; the guidewire lumen extends through the medication lumen; 2. The drug eluting device of claim 1.

20. The shaft has an outer tube having a shaft lumen formed therein.

2. The drug eluting device of claim 1.

21. and a balloon inflation tube having the balloon inflation lumen defined therein, the balloon inflation tube extending through the shaft lumen.

21. The drug eluting device of claim 20.

22. the guidewire tube having the guidewire lumen defined therein, the guidewire tube extending through the shaft lumen; 21. The drug eluting device of claim 20.

23. a proximal portion of the drug tube extends through the shaft lumen, the drug lumen being formed in the proximal portion of the drug tube; 21. The drug eluting device of claim 20.

24. a handle having a medication port configured to receive a medication; a carrier tube connected or connectable to the handle, the carrier tube having a lumen; a drug tube configured to travel through the lumen of the carrier tube, the drug tube having a proximal portion configured to receive a drug from the drug port and a distal portion having a plurality of holes configured to allow the drug to exit the drug tube; having when the distal portion of the drug tube is located within the carrier tube, the distal portion of the drug tube is held in a deformed, radially collapsed state by the carrier tube, and when the distal portion of the drug tube is located outside the carrier tube, the distal portion of the drug tube assumes a relaxed, radially expanded state. Drug elution device.

25. At least the distal portion of the drug tube is made of an elastically deformable material.

25. The drug eluting device of claim 24.

26. the handle has an actuator configured to move the drug tube relative to the carrier tube or move the carrier tube relative to the drug tube.

25. The drug eluting device of claim 24.

27. The carrier tube is configured to be attached to a guide catheter.

25. The drug eluting device of claim 24.

28. when the distal portion of the drug tube is in the relaxed radially expanded state, the distal portion of the drug tube extends in a helical configuration.

25. The drug eluting device of claim 24.

29. when the distal portion of the drug tube is in the relaxed radially expanded state, the distal portion of the drug tube has a plurality of drug tube segments extending from a proximal end of the distal portion to a distal end of the distal portion and curving radially outward relative to a longitudinal axis of the carrier tube.

25. The drug eluting device of claim 24.

30. The drug tube is made of Nitinol or stainless steel.

26. The drug eluting device of claim 25.

31. the drug tube having a radiopaque marker; 25. The drug eluting device of claim 24.

32. 1. A method of delivering a pharmaceutical agent into a vessel, the method comprising: Providing a drug eluting device, the drug eluting device comprising: A handle comprising: a balloon inflation port configured to receive an inflation fluid; and a medication port configured to receive a medication; handle; A shaft connected to the handle: a balloon inflation lumen configured to receive inflation fluid from the balloon inflation port; a medication lumen configured to receive the medication from the medication port; and a guidewire lumen configured to receive a guidewire and allow the guidewire to extend out of the distal portion of the shaft; a shaft having a balloon attached to the distal portion of the shaft and configured to receive the inflation fluid from the balloon inflation lumen; and a drug tube defining a distal portion of the drug lumen, the drug tube having a distal portion connected to an exterior of the balloon and having a plurality of holes configured to allow the drug to exit the drug tube; the steps of: inserting the distal portion of the shaft into a tube; inflating the balloon by supplying the inflation fluid to the balloon through the balloon inflation lumen, causing the distal portion of the drug tube to assume a deformed radially expanded state; and delivering the drug to the vessel via the drug lumen and the plurality of holes in the drug tube; A method comprising:

33. 1. A method of delivering a drug into a vessel, the method comprising: Providing a drug eluting device, the drug eluting device comprising: A handle comprising: a balloon inflation port configured to receive an inflation fluid; and a medication port configured to receive a medication; a handle having A shaft connected to the handle, the shaft comprising: a balloon inflation lumen configured to receive the inflation fluid from the balloon inflation port; a medication lumen configured to receive the medication from the medication port; and a guidewire lumen configured to receive a guidewire and allow the guidewire to extend out of the distal portion of the shaft; a shaft having a balloon attached to the distal portion of the shaft and configured to receive the inflation fluid from the balloon inflation lumen; a carrier tube connected to the handle, the carrier tube configured to allow the shaft to move therethrough, the carrier tube having a length equal to or greater than a length of the shaft; and a drug tube defining a distal portion of the drug lumen, the drug tube having a distal portion connected to the exterior of the balloon and having a plurality of holes configured to allow the drug to exit the drug tube; the steps of: inserting the distal portion of the shaft into a tube; pushing the shaft or pulling the carrier tube such that the distal portion of the drug tube and the balloon are outside of the carrier tube, causing the distal portion of the drug tube to adopt a relaxed radially expanded state; inflating the balloon by supplying the inflation fluid to the balloon through the balloon inflation tube; and delivering the drug into the vessel through the drug tube and the plurality of holes in the drug tube; A method comprising:

34. The method further comprises: inserting a guide catheter into the vessel prior to inserting the distal portion of the shaft into the vessel; In the step of inserting the distal portion of the shaft into the vessel, the distal portion of the shaft is inserted into the guide catheter; and pushing the shaft such that, in the step of pushing the shaft or pulling the carrier tube, the distal portion of the drug tube and the balloon are outside the guide catheter; Further comprising:

34. The method of claim 33.

35. 1. A method of delivering a pharmaceutical agent into a vessel, the method comprising: Providing a drug eluting device, the drug eluting device comprising: A handle comprising: a balloon inflation port configured to receive an inflation fluid; and a medication port configured to receive a medication; a handle having A shaft connected to the handle, the shaft comprising: a balloon inflation lumen configured to receive the inflation fluid from the balloon inflation port; a medication lumen configured to receive the medication from the medication port; and a guidewire lumen configured to receive a guidewire and allow the guidewire to extend out of the distal portion of the shaft; a shaft having a balloon attached to the distal portion of the shaft and configured to receive the inflation fluid from the balloon inflation lumen; a carrier tube connected or connectable to the handle, the carrier tube configured to allow the shaft to travel therethrough, the carrier tube configured to be attached to a guide catheter; and a drug tube defining a distal portion of the drug lumen, the drug tube having a distal portion connected to an exterior of the balloon and having a plurality of holes configured to allow the drug to exit the drug tube; having the carrier tube having a length approximately equal to an axial length of the distal portion of the medication tube; inserting the distal portion of the shaft, the carrier tube, and the guide catheter into a vessel; pushing the shaft so that the distal portion of the drug tube and the balloon are outside of the carrier tube and the guide catheter, causing the distal portion of the drug tube to assume a relaxed, radially expanded state; inflating the balloon by supplying the inflation fluid to the balloon through the balloon inflation tube; and delivering the drug into the vessel through the drug tube and the plurality of holes in the drug tube; A method comprising:

36. 1. A method of delivering a pharmaceutical agent into a vessel, the method comprising: Providing a drug eluting device, the drug eluting device comprising: a handle including a medication port configured to receive a medication; a carrier tube connected to the handle, the carrier tube having a lumen; a drug tube configured to travel through the lumen of the carrier tube, the drug tube having a proximal portion configured to receive a drug from the drug port and a distal portion having a plurality of holes configured to allow the drug to exit the drug tube; having when the distal portion of the drug tube is located within the carrier tube, the distal portion of the drug tube is held by the carrier tube in a deformed, radially collapsed state, and when the distal portion of the drug tube is outside of the carrier tube, the distal portion of the drug tube assumes a relaxed, radially expanded state; the carrier tube has a length equal to or greater than the axial length of the drug tube; Steps: inserting the distal portion of the carrier tube into a vessel; pushing the drug tube or pulling the carrier tube so that the distal portion of the drug tube is outside of the carrier tube, causing the distal portion of the drug tube to assume a relaxed radially expanded state, the drug tube receiving the drug from the drug port; and delivering the drug into the vessel through the drug tube and the plurality of holes in the drug tube; A method comprising:

37. The method further comprises: inserting a guide catheter into the vessel prior to inserting the distal portion of the shaft into the vessel; In the step of inserting the distal portion of the shaft into the vessel, the distal portion of the shaft is inserted into the guide catheter; and pushing the shaft such that, in the step of pushing the shaft or pulling the carrier tube, the distal portion of the drug tube and the balloon are outside the guide catheter; Including, 37. The method of claim 36.

38. 1. A method of delivering a pharmaceutical agent into a vessel, the method comprising: Providing a drug eluting device, the drug eluting device comprising: a handle including a medication port configured to receive a medication; a carrier tube connected or connectable to the handle, the carrier tube having a lumen, the carrier tube configured to be attached to a guide catheter; a drug tube configured to travel through the lumen of the carrier tube, the drug tube having a proximal portion configured to receive a drug from the drug port and a distal portion having a plurality of holes configured to allow the drug to exit the drug tube; having when the distal portion of the drug tube is located within the carrier tube, the distal portion of the drug tube is held by the carrier tube in a deformed, radially collapsed state, and when the distal portion of the drug tube is outside of the carrier tube, the distal portion of the drug tube assumes a relaxed, radially expanded state; the carrier tube having an axial length approximately equal to a length of the distal portion of the medication tube; Steps: inserting the distal portion of the carrier tube and the guide catheter into a duct; pushing the drug tube such that the distal portion of the drug tube is outside of the carrier tube and the guide catheter, causing the distal portion of the drug tube to assume a relaxed radially expanded state, the drug tube receiving the drug from the drug port; and delivering the drug into the vessel through the drug tube and the plurality of holes in the drug tube; A method comprising:

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