Drug-eluting devices and drug delivery methods

Abstract

The drug-eluting device includes a handle including a drug port configured to receive a drug; a shaft connected to the handle, the shaft including a drug lumen configured to receive a drug from the drug port and a guidewire tube configured to receive a guidewire so that the guidewire can extend out of a distal portion of the shaft; a balloon attached to the distal portion of the shaft, the balloon configured to receive a drug from the drug lumen, the balloon including holes configured to allow the drug to exit the balloon; an anchor connected to the distal portion of the balloon; an elastically deformable wire having a distal end connected to the distal portion of the balloon and a proximal end connected to the guidewire tube; and a pull wire connected to the anchor.

Description

[Technical field]

[0001] This application relates generally to drug-eluting devices for delivering drugs, such as drugs including anti-proliferative drugs, into a blood vessel. More specifically, this application relates to drug-eluting devices that allow a drug-delivery balloon to be compressed to deliver additional portions of the drug into the blood vessel and reduce the amount of drug remaining in the balloon.

[0002] Vascular disease can cause stenosis and restenosis of blood vessels, which is a health hazard unless plaque builds up on the vessel walls, narrowing the vessel and reopening it by a treatment such as angioplasty. During angioplasty, an expansion device such as a balloon is inserted into the blood vessel, advanced to the site of the narrowing, and then expanded radially outward against the vessel wall to expand the blood vessel. Such devices can also deliver drugs to the blood vessel, for example, via the balloon. Summary of the Invention

[0003] In known drug eluting devices, after the balloon is expanded, most of the drug remains within the balloon and is wasted.

[0004] According to certain embodiments, after the balloon is expanded within the vessel, the balloon is compressed to deliver an additional portion of the drug into the vessel and reduce the amount of drug remaining within the balloon.

[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 shaft connected to the handle. The shaft includes a drug lumen configured to receive a drug from the drug port and a guidewire tube 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 the distal portion of the shaft and configured to receive a drug from the drug lumen, the balloon including a plurality of holes configured to allow the drug to exit the balloon. The drug eluting device also includes an anchor connected to the distal portion of the balloon. The drug eluting device also includes an elastically deformable wire having a distal end connected to the distal portion of the balloon and a proximal end connected to the guidewire tube. The drug eluting device also includes a pull wire connected to the anchor. The handle includes an actuator actuable by a user to change the balloon from a longitudinally expanded state to a longitudinally compressed state by pulling the pull wire. After pulling the pull wire to compress the balloon, the elastically deformable wire returns the balloon to a longitudinally expanded state.

[0006] 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 shaft connected to the handle, the shaft including a drug lumen configured to receive a drug from the drug port, and a guidewire tube configured to receive a guidewire so that the guidewire can extend out of a distal portion of the shaft. The drug eluting device also includes a carrier tube connected or connectable to the handle, the carrier tube surrounding the shaft. The drug eluting device also includes a balloon attached to the distal portion of the shaft, the balloon configured to receive a drug from the drug lumen, the balloon including a plurality of holes configured to allow the drug to exit the balloon. The handle includes an actuator actuable by a user to pull the shaft, thereby drawing the balloon into the carrier tube and changing the balloon from a radially expanded state to a radially compressed state.

[0007] 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 shaft connected to the handle. The shaft includes a drug lumen configured to receive a drug from the drug port and a guidewire tube configured to receive a guidewire to allow the guidewire to extend out of a distal portion of the shaft. The drug eluting device also includes a balloon attached to the distal portion of the shaft and configured to receive a drug from the drug lumen, the balloon including a plurality of holes configured to allow the drug to exit the balloon. The drug eluting device also includes an anchor connected to a distal portion of the balloon. The drug eluting device also includes a pull wire connected to the anchor. The handle includes an actuator actuable by a user to change the balloon from a longitudinally expanded state to a longitudinally compressed state by pulling on the pull wire. The longitudinally compressed state of the balloon is an inverted state.

[0008] 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 first shaft connected to the handle, the first shaft including a drug lumen configured to receive a drug from the drug port. The drug eluting device also includes a second shaft connected to the handle, the second shaft configured to move independently through the first shaft, the second shaft configured to receive a guidewire such that the guidewire can extend out of a distal portion of the second shaft. The drug eluting device also includes a balloon including a proximal portion connected to the distal portion of the first shaft and a distal portion connected to the distal portion of the second shaft. The balloon is configured to receive a drug from the drug lumen, the balloon including a plurality of holes configured to allow the drug to exit the balloon. The actuator is user actuable to change the balloon from a radially expanded state to a radially compressed state by rotating the second shaft relative to the first shaft.

[0009] In some embodiments, a method of delivering a drug into a blood vessel includes providing a drug eluting device, the drug eluting device including a handle including a drug port configured to receive a drug. The drug eluting device also includes a shaft connected to the handle. The shaft includes a drug lumen configured to receive a drug from the drug port and a guidewire tube configured to receive a guidewire to allow the guidewire to extend out of a distal portion of the shaft. The drug eluting device also includes a balloon attached to the distal portion of the shaft and configured to receive a drug from the drug lumen, the balloon including a plurality of holes configured to allow the drug to exit the balloon. The drug eluting device also includes an anchor connected to the distal portion of the balloon. The drug eluting device also includes an elastically deformable wire having a distal end connected to the distal portion of the balloon and a proximal end connected to the guidewire tube. The drug eluting device also includes a pull wire connected to the anchor. The handle includes an actuator actuable by a user to change the balloon from a longitudinally expanded state to a longitudinally compressed state by pulling on the pull wire. After pulling the pull wire to compress the balloon, the elastically deformable wire returns the balloon to the longitudinally expanded state. The method also includes inserting a distal portion of the shaft into the blood vessel. The method also includes supplying a drug to the balloon through the drug lumen to inflate the balloon and deliver the drug into the blood vessel through a plurality of holes in the balloon. The method also includes using an actuator to pull the pull wire to compress the balloon, thereby changing the balloon from the longitudinally expanded state to a longitudinally compressed state and expelling at least a portion of the drug remaining within the balloon. The method also includes returning the balloon to the longitudinally expanded state with the elastically deformable wire.

[0010] In some embodiments, a method of delivering an agent into a blood vessel includes providing a drug-eluting device, the drug-eluting device including a handle including a drug port configured to receive an agent. The drug-eluting device also includes a shaft connected to the handle, the shaft including a drug lumen configured to receive an agent from the drug port and a guidewire tube configured to receive a guidewire so that the guidewire can extend out of a distal portion of the shaft. The drug-eluting device also includes a carrier tube connected to the handle, the carrier tube surrounding the shaft. The length of the carrier tube is equal to or greater than the length of the shaft. The drug-eluting device also includes a balloon attached to the distal portion of the shaft and configured to receive an agent from the drug lumen, the balloon including a plurality of holes configured to allow the agent to exit the balloon. The handle includes an actuator actuable by a user to pull the shaft to retract the balloon into the carrier tube and change the balloon from a radially expanded state to a radially compressed state. The method also includes inserting the distal portion of the shaft and the distal portion of the carrier tube into the blood vessel. The method also includes pushing the shaft or pulling the carrier tube so that a distal portion of the shaft and the balloon are outside the carrier tube. The method also includes supplying a drug to the balloon through the drug lumen to inflate the balloon and deliver the drug into the blood vessel through a plurality of holes in the balloon. The method also includes compressing the balloon by pulling the shaft using an actuator, thereby drawing the balloon into the carrier tube, changing the balloon from a radially expanded state to a radially compressed state, and expelling at least a portion of the drug remaining in the balloon.

[0011] In some embodiments, a method of delivering an agent into a blood vessel includes providing a drug-eluting device, the drug-eluting device including a handle including a drug port configured to receive an agent. The drug-eluting device also includes a shaft connected to the handle, the shaft including a drug lumen configured to receive an agent from the drug port and a guidewire tube 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 carrier tube connected to or connectable to the handle, the carrier tube surrounding the shaft. The length of the carrier tube is less than the length of the shaft. The drug-eluting device also includes a balloon attached to the distal portion of the shaft and configured to receive an agent from the drug lumen, the balloon including a plurality of holes configured to allow the agent to exit the balloon. The handle includes an actuator actuable by a user to pull the shaft to retract the balloon into the carrier tube and change the balloon from a radially expanded state to a radially compressed state. The method also includes inserting the distal portion of the shaft and the distal portion of the carrier tube into the blood vessel. The method also includes pushing the shaft so that a distal portion of the shaft and the balloon are outside of the carrier tube and the guide catheter. The method also includes supplying an agent to the balloon through the agent lumen to inflate the balloon and deliver the agent into the blood vessel through a plurality of holes in the balloon. The method also includes compressing the balloon by pulling the shaft using the actuator, thereby drawing the balloon into the guide catheter, changing the balloon from a radially expanded state to a radially compressed state, and expelling at least a portion of the agent remaining within the balloon.

[0012] In some embodiments, a method of delivering an agent into a blood vessel includes providing a drug eluting device, the drug eluting device including a handle including a drug port configured to receive an agent. The drug eluting device also includes a shaft connected to the handle. The shaft includes a drug lumen configured to receive an agent from the drug port and a guidewire tube configured to receive a guidewire to 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 agent from the drug lumen, the balloon including a plurality of holes configured to allow the agent to exit the balloon. The drug eluting device also includes an anchor connected to a distal portion of the balloon. The drug eluting device also includes a pull wire connected to the anchor. The handle includes an actuator actuable by a user to change the balloon from a longitudinally expanded state to a longitudinally compressed state by pulling the pull wire. The longitudinally compressed state of the balloon is an inverted state. The method also includes inserting a distal portion of the shaft into the blood vessel. The method also includes supplying a drug to the balloon through the drug lumen to inflate the balloon and deliver the drug into the blood vessel through a plurality of holes in the balloon. The method also includes compressing the balloon by pulling the pull wire using the actuator to change the balloon from a longitudinally expanded state to a longitudinally compressed state to expel at least a portion of the drug remaining within the balloon. The longitudinally compressed state of the balloon is an inverted state.

[0013] In some embodiments, a method of delivering a drug to a blood vessel includes providing a drug-eluting device, the drug-eluting device including a handle including a drug port configured to receive a drug. The drug-eluting device also includes a first shaft connected to the handle, the first shaft including a drug lumen configured to receive a drug from the drug port. The drug-eluting device also includes a second shaft connected to the handle, the second shaft configured to move independently through the first shaft, the second shaft receiving a guidewire such that the guidewire can extend out of a distal portion of the second shaft. The drug-eluting device also includes a balloon including a proximal portion connected to the distal portion of the first shaft and a distal portion connected to the distal portion of the second shaft. The balloon is configured to receive a drug from the drug lumen, the balloon including a plurality of holes configured to allow the drug to exit the balloon. The actuator is user-actuable to change the balloon from a radially expanded state to a radially compressed state by rotating the second shaft relative to the first shaft. The method also includes inserting a distal portion of the first shaft and a distal portion of the second shaft into the blood vessel. The method also includes supplying a drug to the balloon through the drug lumen to inflate the balloon and deliver the drug into the blood vessel through a plurality of holes in the balloon. The method also includes compressing the balloon by rotating the second shaft relative to the first shaft using an actuator to change the balloon from a radially expanded state to a radially compressed state and expelling at least a portion of the drug remaining within the balloon. [Brief description of the drawings]

[0014] 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 will be described with more specificity and detail using the accompanying drawings, with the understanding that these drawings illustrate only some embodiments according to the present disclosure and are therefore not intended to limit its scope. [Figure 1A] FIG. 2 is a left side view of the drug-eluting device in a first configuration according to a first embodiment, with the balloon inflated to a longitudinally expanded state. [Figure 1B] FIG. 2 is a left side view of the drug-eluting device in a second configuration according to the first embodiment, with the balloon longitudinally compressed by the anchor. [Figure 1C] FIG. 2 is a left side view of the drug-eluting device in a third configuration according to the first embodiment after the balloon has returned to its longitudinally expanded state. [Figure 2A] FIG. 2 is a front, top, left side perspective view of a handle that may be included in the drug-eluting device of a first embodiment. [Figure 2B] FIG. 2B is a front, top, left side perspective view of the handle of FIG. 2A in an alternative configuration in which the actuator is adapted to move the pull wire. [Figure 2C] FIG. 2B is a front, bottom, left side perspective view of the hub included in the handle of FIG. 2A, showing the stop cock. [Diagram 3] FIG. 1 is a left side view of a portion of a drug eluting device according to a first embodiment. [Figure 4A] 4 is a cross-sectional view of a portion of a drug-eluting device according to a first embodiment taken along plane AA of FIG. 3. [Figure 4B] 4 is a cross-sectional view of a portion of a drug-eluting device according to a first embodiment taken along plane BB of FIG. 3. [Figure 4C] 4 is a cross-sectional view of a portion of a drug-eluting device according to a first embodiment taken along plane CC of FIG. 3. [Figure 5A] 4 is a cross-sectional view of a portion of a drug-eluting device according to a first embodiment taken along plane AA of FIG. 3. [Figure 5B] 4 is a cross-sectional view of a portion of a drug-eluting device according to a first embodiment taken along plane BB of FIG. 3. [Figure 5C] 4 is a cross-sectional view of a portion of a drug-eluting device according to a first embodiment taken along plane CC of FIG. 3. [Figure 6A]FIG. 2 is a front, top, left side perspective view of a distal portion of a drug-eluting device according to a first embodiment with the balloon inflated and in a longitudinally expanded state. [Figure 6B] 6B is a front, top, left side perspective view of a cross section of the distal portion of the first embodiment of the drug-eluting device taken along plane AA of FIG. 6A with the balloon inflated to a longitudinally expanded state. FIG. [Figure 6C] 6B is a front, top, left side perspective view of a cross section of the distal portion of the first embodiment of the drug-eluting device taken along plane AA of FIG. 6A with the balloon inflated to a longitudinally expanded state. FIG. [Figure 7A] FIG. 6C is a front cross-sectional view of the distal portion of the first embodiment of the drug-eluting device taken along plane AA of FIG. 6B, with the anchors not connected to the balloon and guidewire tube. [Figure 7B] 6D is a cross-sectional front view of the distal portion of the first embodiment of the drug-eluting device taken along plane AA of FIG. 6C, with the anchors not connected to the balloon and guidewire tube. [Figure 7C] FIG. 6C is a front cross-sectional view of the distal portion of the drug-eluting device of the first embodiment taken along plane AA of FIG. 6B or FIG. 6C with the anchor connected to the balloon and guidewire tube. [Figure 8A] FIG. 13 is a left side view of a drug eluting device in a first configuration according to a second embodiment, with the shaft within a carrier tube. [Figure 8B] FIG. 13 is a left side view of the drug eluting device in a second configuration according to the second embodiment, with the distal end of the shaft positioned distal to the carrier tube. [Figure 8C] FIG. 13 is a left side view of the drug-eluting device in a third configuration according to the second embodiment, with the balloon inflated to a radially expanded state. [Figure 8D] FIG. 13 is a left side view of the drug-eluting device in a fourth configuration according to the second embodiment, with the balloon retracted into the carrier tube and in a radially compressed state. [Figure 9A]FIG. 13 is a front, top, left side perspective view of a handle that may be included in a second embodiment of a drug-eluting device. [Figure 9B] FIG. 9B is a front, bottom, left side perspective view of the hub included in the handle of FIG. 9A, showing the stop cock. [Figure 10A] FIG. 13 is a right side view of a portion of a drug-eluting device in a first configuration according to a second embodiment, with the balloon inflated to a radially expanded state. [Figure 10B] FIG. 13 is a right side view of a portion of a drug-eluting device in a second configuration according to a second embodiment, with the balloon radially compressed relative to and partially retracted within the carrier tube. [Figure 10C] FIG. 13 is a right side view of a portion of the drug-eluting device in a third configuration according to the second embodiment, with the balloon radially compressed relative to the carrier tube and further fully retracted within the carrier tube. [Figure 11A] FIG. 13 is a left side view of a drug-eluting device in a first configuration according to a variation of the second embodiment, with the balloon inflated to a radially expanded state. [Figure 11B] FIG. 13 is a left side view of the drug-eluting device in a second configuration according to a variation of the second embodiment, with the balloon retracted to a radially compressed state within the carrier tube. [Figure 12] FIG. 13 is a front, top, left side perspective view of a distal portion of a drug-eluting device according to a variation of the second embodiment, with the balloon inflated to a radially expanded state. [Figure 13A] FIG. 13 is a left side view of a drug eluting device according to a third embodiment. [Figure 13B] FIG. 13 is a left side view of a portion of a drug-eluting device in a first configuration according to a third embodiment, with the balloon inflated to a longitudinally expanded state. [Figure 13C] FIG. 13 is a left side view of a portion of a drug-eluting device in a second configuration according to a third embodiment, with the balloon in an inverted state with longitudinal compression. [Figure 14A]FIG. 13 is a front, top, left side perspective view of a distal portion of a third embodiment of a drug-eluting device with the balloon inflated and in a longitudinally expanded state. [Figure 14B] FIG. 14B is a left-side cross-sectional view of the distal portion of the drug-eluting device of the third embodiment taken along plane AA of FIG. 14A with the balloon inflated to a longitudinally expanded state. [Figure 15A] FIG. 13 is a left side view of a portion of a drug-eluting device in a first configuration according to a fourth embodiment, with the balloon inflated to a radially expanded state. [Figure 15B] FIG. 13 is a left side view of a portion of a drug-eluting device in a second configuration according to a fourth embodiment, with the balloon compressed to a radially compressed state. [Figure 16] FIG. 13 is a left side view in cross section of a handle that may be included in the drug eluting device of the fourth embodiment. [Figure 17A] FIG. 2 is a right side view of the drug eluting device for use with a short carrier tube and guide catheter in a first configuration. [Figure 17B] 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. [Figure 17C] 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. [Figure 17D] 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. [Figure 18A] FIG. 2 is a right side view of the drug eluting device for use with a long carrier tube in a first configuration. [Figure 18B] FIG. 13 is a right side view of the drug eluting device for use with a long carrier tube in a second configuration. [Figure 18C] FIG. 13 is a right side view of the drug eluting device for use with a long carrier tube in a third configuration. [Figure 19A] 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. [Figure 19B] 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. [Figure 19C] 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. [Figure 19D] 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 apparatus in a fourth configuration. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0015] In the following detailed description, reference is made to the accompanying drawings, which form a part hereof. In the drawings, like symbols typically refer to 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 and illustrated in the figures herein, can be arranged, substituted, combined, and designed in a wide variety of different configurations, all of which are expressly contemplated and made a part of this disclosure.

[0016] To reduce costs associated with drug-eluting devices, it may be desirable to reduce the amount of drug remaining in the balloon after the balloon is expanded within the vessel. However, it may be difficult to deliver the drug into the vessel without leaving some of the drug within the balloon. Any drug remaining in the balloon may not be retrieved and used for another patient, thus wasting the drug remaining in the balloon.

[0017] Various embodiments of the drug eluting device described herein may provide one or more advantages including, for example, (1) reducing costs associated with operating the drug eluting device by allowing a reduced amount of drug to be inserted into the drug eluting device, and (2) facilitating the ability of a user of the drug eluting device to operate the drug eluting device.

[0018] Various embodiments of the drug eluting device described herein can be used with a guide catheter. The guide catheter can be inserted into the blood vessel before the drug eluting device. The drug eluting device can be connected to the guide catheter to facilitate the entry of a portion of the drug eluting device into the blood vessel. The guide catheter can be used to protect the blood vessel from potential trauma that may be caused by the use of the drug eluting device. The guide catheter can be positioned at or near the target of drug elution.

[0019] Various embodiments of the drug eluting device described herein can be used with a carrier tube. The carrier tube can surround the shaft and / or balloon of the drug eluting device. The carrier tube can facilitate the advancement of a portion of the drug eluting device into a blood vessel. The carrier tube is used to apply an external force to the balloon and hold it in a radially compressed deformed state. The carrier tube can be positioned at or near the target for drug elution.

[0020] As used herein, the term "proximal end" refers to the end of the drug eluting device that is closer to the user, and the term "distal end" refers to the end that is closer to the subject on which the drug eluting procedure is performed via the drug eluting device.

[0021] First embodiment 1A-7C show a drug-eluting device 100 (e.g., a therapeutic device, etc.) for delivering a drug (e.g., a drug including an anti-proliferative agent such as sirolimus) into a blood vessel according to a first embodiment. The drug-eluting device 100 includes a handle 106 having a drug port 104 configured to receive a drug. The drug-eluting device 100 further includes a shaft 110 connected to the handle 106. The shaft 110 has a drug lumen 114 configured to receive a drug from the drug port 104 and a guidewire tube 116 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 further includes a balloon 130 attached to the distal portion 110d of the shaft 110 and configured to receive a drug from the drug lumen 114, the balloon 130 having a plurality of holes 132 to allow the drug to exit the balloon 130. The drug eluting device 100 further includes an anchor 140 connected to the distal portion of the balloon 130. The drug eluting device 100 further includes an elastically deformable wire 150 having a distal end 150d connected to the distal portion 130d of the balloon 130 and a proximal end 150p connected to the guidewire tube 116. The drug eluting device 100 further includes a pull wire 128 connected to the anchor 140. The handle 106 further includes an actuator 108 that is user actuatable to change the balloon 130 from a longitudinally expanded state 134a to a longitudinally compressed state 134b by pulling the pull wire 128. After pulling the pull wire 128 to compress the balloon 130, the elastically deformable wire 150 causes the balloon 130 to return to the longitudinally expanded state 134a. In some embodiments, the drug eluting device 100 may further include a stop cock 102 connected to the drug port 104. In some embodiments, the shaft 110 may further include a pullwire lumen 118 , with the pullwire 128 positioned within the pullwire lumen 118 of the shaft 110 .

[0022] The drug-eluting device 100 includes a handle 106 (e.g., a grip, a hand grip, etc.). The handle 106 is configured to be grasped by a user and allows the user to manipulate the drug-eluting device 100. The handle 106 may be configured to be grasped in one hand to allow the user to perform additional manipulations with the other hand.

[0023] 2A-2B, handle 106 includes a body 107 (e.g., a shell, housing, container, etc.). Body 107 of handle 106 holds hub 101, stop cock 102, drug port 104, and actuator 108 together. Body 107 of handle 106 allows a user to hold handle 106 and operate drug-eluting device 100.

[0024] The body 107 may be made from 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.

[0025] The handle 106 also includes a hub 101. In FIG. 2A, the hub is located proximally of the handle 106. However, in other embodiments, the hub 101 may be located at the top, bottom, left, right, or proximal side of the handle 106. The hub 101 includes a drug port 104 (e.g., a hole, an opening, an aperture, etc.) configured to receive a drug. As in FIG. 2C, the hub 101 may also include a stop cock 102 (e.g., a valve, etc.). The stop cock 102 allows a user of the drug-eluting device 100 to control the flow of drug into the drug-eluting device 100. When the stop cock 102 is in a closed position, the drug lumen 114 is sealed, thereby preventing drug from flowing proximally or distally past the stop cock 102. Thus, when the balloon 130 is compressed, the drug is forced out of the balloon 130 through the multiple holes 132, rather than flowing proximally through the drug lumen 114. Stopcock 102 is located distal to drug port 104 so that when stopcock 102 is open, drug can be provided to drug port 104 and flow through stopcock 102. In other embodiments, stopcock 102 may be separate from hub 101. For example, hub 101 may be located proximal to handle 106 with stopcock 102 located distal to handle 106.

[0026] The handle 106 also includes an actuator 108 (e.g., a tab, button, wheel, knob, etc.). The actuator 108 may be a mechanical structure that is actuable by a user to operate the drug eluting device 100. The actuator 108 is configured such that a user of the drug eluting device 100 can move the actuator 108 along a longitudinal axis A along the length of the handle 106. L In another embodiment, the actuator 108 is actuated by moving it proximally or distally in a direction parallel to the longitudinal axis A of the drug eluting device 100. L2B, the actuator 108 has been moved proximally as compared to FIG. 2A, which results in the pull wire 128 being pulled proximally, tensioning the anchor 140, compressing the balloon 130 longitudinally, and discharging the drug from the multiple holes 132 in the balloon 130. In FIG. 2A, the actuator 108 is located on the top side of the handle 106. However, in other embodiments, the actuator 108 may be located on the bottom, left, or right side of the handle 106.

[0027] 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 an adhesive bond, an interlocking mechanism, a press fit, a threaded fastener, or other suitable connection configuration. The shaft may be permanently fixed to the handle 106 such that a user cannot remove the shaft 110 from the handle 106.

[0028] 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, fluoroplastic, or other suitable material.

[0029] The length of the shaft 110 may be in the range of about 30-300 cm, for example 50-300 cm, or 100-250 cm. As used herein, the range of X to Y includes X, Y, and values ​​between X and Y.

[0030] 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) that is in the range of about 0.5 to 10 mm (inclusive), and ideally is 0.5 to 7 mm.

[0031] 3 shows a portion of the drug-eluting device 100. The drug-eluting device 100 may be a rapid exchange type device, in which case 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 may be an over-the-wire type device, in which case the guidewire 126 enters the shaft 110 through the handle 106. A guidewire tube 116 configured to receive the guidewire 126 extends longitudinally through a portion of the length of the shaft 110.

[0032] In FIGS. 4A-4C and 5A-5C, shaft 110 includes drug lumen 114 (e.g., cavity, space, etc.) and guidewire tube 116 (e.g., pipe, cylinder, conduit, etc.). In some embodiments, such as FIGS. 4A-4C and 5A-5C, shaft 110 includes pullwire lumen 118 (e.g., cavity, space, etc.), and FIGS. 4A-4C show cross sections of shaft 110 in planes AA, BB, and CC of FIG. 3, respectively. In the embodiment of FIGS. 4A-4C, guidewire tube 116 is separate from drug lumen 114. In the embodiment of FIGS. 5A-5C, guidewire tube 116 extends through drug lumen 114. FIGS. 5A-5C show cross sections of alternative shaft 110 in planes AA, BB, and CC of FIG. 3, respectively.

[0033] Drug lumen 114 extends longitudinally through shaft 110. Drug lumen 114 is configured to receive a drug from drug port 104. The cross-sectional shape of drug lumen 114 may be circular, elliptical, polygonal, rounded polygonal, or other geometric shape. The maximum cross-sectional width of drug lumen 114 (e.g., diameter when the cross-sectional shape is circular) may be in the range of about 1 μm to 15 mm (inclusive), and ideally 0.1 to 3 mm.

[0034] In some embodiments, the shaft 110 has a pullwire lumen 118 that extends longitudinally through the shaft 110. The cross-sectional shape of the pullwire lumen 118 may be circular, elliptical, polygonal, rounded polygonal, or other geometric shape. The maximum cross-sectional width of the pullwire lumen 118 (e.g., diameter when the cross-sectional shape is circular) may be in the range of about 0.1-10 mm (inclusive), and ideally 0.1-3 mm. In FIGS. 4A-4C and 5A-5C, the shaft 110 has two pullwire lumens 118. However, in other embodiments, the shaft 110 may have one, two, three, or more pullwire lumens 118.

[0035] As shown in FIG. 3, guidewire tube 116 is configured to receive guidewire 126 such that guidewire 126 extends out from distal portion 110d of shaft 110. Guidewire tube 116 extends longitudinally through a portion of shaft 110. The cross-sectional shape of guidewire tube 116 may be circular, elliptical, polygonal, rounded polygonal, or other geometric shape. The maximum cross-sectional width of guidewire tube 116 (e.g., diameter when the cross-sectional shape is circular) may be in the range of about 0.1 to 1 mm (inclusive), and ideally 0.35 to 0.9 mm.

[0036] 4A-4C, the drug lumen 114, the guidewire tube 116, and the pullwire lumen 118 are positioned within the shaft 110 such that the drug lumen 114 is in the center of the shaft 110, the guidewire tube 116 is at the top of the shaft 110, and the pullwire lumen 118 is at the top of the shaft 110. In other embodiments, the drug lumen 114, the guidewire tube 116, and the pullwire lumen 118 may be positioned elsewhere on the shaft 110 and in different relative positions relative to each other as compared to the arrangement of FIGS. 4A-4C. In FIGS. 5A-5C, the drug lumen 114, the guidewire tube 116, and the pullwire lumen 118 are positioned within the shaft 110 such that the drug lumen 114 is in the center of the shaft 110, the guidewire tube 116 is at the top and center of the shaft 110, and the pullwire lumen 118 is at the top of the shaft 110. In other embodiments, agent lumen 114, guidewire tube 116, and pullwire lumen 118 may be positioned elsewhere on shaft 110 and in different relative positions to one another as compared to the arrangement of FIGS. 5A-5C.

[0037] 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 bonded by adhesive, welding, or other suitable connection configuration. The balloon 130 is configured to receive a drug from the drug lumen 114. When the drug enters the balloon 130 from the drug lumen 114, the balloon 130 expands to a longitudinally expanded state 134a. The balloon 130 may have preset folds or creases to guide the shape of the balloon 130 when the balloon 130 is longitudinally compressed. The preset folds or creases of the balloon 130 may be configured to allow the balloon 130 to longitudinally compress in an orderly manner.

[0038] The balloon 130 may be made of polyamide, polyester, polyurethane, polyamide elastomer, polyester elastomer, polyurethane elastomer, or other suitable material.

[0039] The length of the balloon 130 may be in the range of about 10 to 400 mm, for example, 10 to 50 mm, or 15 to 40 mm. The width of the balloon 130 may be in the range of about 1 to 8 mm, for example, 2 to 5 mm, or 4 to 8 mm.

[0040] The balloon 130 includes a number of holes 132 (e.g., apertures, openings, slits, etc.) configured to allow the agent to exit the balloon 130. When the balloon 130 is expanded to a longitudinally expanded state 134a, the agent passes through the number of holes 132 in the balloon 130, exits the balloon 130, and enters the blood vessel.

[0041] The pores 132 of the balloon 130 may each have a width in the range of about 100 nm to 10 μm, and ideally 100 nm to 5 μm. In FIG. 1A, the pores 132 of the balloon 130 may have the same width. However, in other embodiments, the pores 132 of the balloon 130 may have different widths.

[0042] Each of the plurality of holes 132 in the balloon 130 may have a circular, elliptical, rounded polygonal, slit, or other geometric shape. In FIG. 1A, the plurality of holes 132 in the balloon 130 have the same shape. However, in other embodiments, the plurality of holes 132 in the balloon 130 may have different shapes.

[0043] 1A, the holes 132 in the balloon 130 are positioned such that there is uniform spacing between the holes 132 in the balloon 130. However, in other embodiments, the holes 132 in the balloon 130 may be positioned such that there is different spacing between the holes 132 in the balloon 130.

[0044] The drug-eluting device 100 also includes an anchor 140 (e.g., a block, weight, cap, etc.). The anchor 140 is connected to the distal portion 130d of the balloon 130. The anchor 140 may be connected to the distal portion 130d of the balloon 130 by swaging, crimping, or other suitable connection configuration. In FIGS. 7A-7B, the anchor 140 includes an inner portion 140i and an outer portion 140o. The balloon 130 and the elastically deformable wire 150 may be positioned between the inner portion 140i of the anchor 140 and the outer portion 140o of the anchor 140. The inner portion 140i of the anchor 140 may be positioned to surround the guidewire tube 116. The guidewire tube 116, the inner portion 140i of the anchor 140, the elastically deformable wire 150 or the elastically deformable wire portions 152, the balloon 130, and the outer portion 140o of FIG. 7A or FIG. 7B are connected by swaging, crimping, or other suitable connection configuration, and these components may be connected as in the configuration of FIG. 7C. In FIG. 7C, the elastically deformable wire 150 or the elastically deformable wire portions 152 are between the inner portion 140i of the anchor 140 and the balloon 130, which are swaged. In some embodiments, the balloon 130 can include a distal shaft where the balloon 130 connects to the anchor 140, which reduces the likelihood of the distal portion of the drug-eluting device 100 being traumatic to the blood vessel.

[0045] Anchor 140 may be made of plastic, nitinol, gold, platinum, stainless steel, tungsten, tantalum, or other suitable materials. Anchor 140 may have a width ranging from about 0.5 to 10 mm, such as 1 to 4 mm. In FIG. 6A, anchor 140 has a cylindrical shape. However, in other embodiments, anchor 140 may have a cylindrical, elliptical, hemispherical, or other shape.

[0046] The drug-eluting device 100 also includes an elastically deformable wire 150 (e.g., thread, strand, line, filament, etc.). The elastically deformable wire 150 has a distal end 150d connected to an anchor 140, which is connected to a distal portion 130d of the balloon 130, as shown in Figures 7A-7C. A proximal end 150p of the elastically deformable wire 150 is connected to the guidewire tube 116 via a marker band 154 (e.g., a hoop, band, disk, etc.), which may be connected via blading, swaging, press-fitting, welding, crimping, or other suitable connection configuration.

[0047] The marker band 154 may be made of gold, platinum, stainless steel, tungsten, tantalum, or other suitable material. The marker band 154 may be made of a radiopaque material. When the marker band 154 is made of a radiopaque material, the marker band 154 may be imaged using an imaging modality, such as x-ray, fluoroscopy, or other suitable imaging modality. The radiopaque material of the marker band 154 facilitates detection and tracking of the distal portion 110d of the shaft 110 by imaging when the distal portion 110d of the shaft 110 is within a blood vessel. Such detection and tracking of the marker band 154 may improve the manipulation and positioning of the drug-eluting device 100 within a blood vessel and improve targeting of a location of a portion of a blood vessel. This is because the location of the marker band 154 by imaging may provide a user with information regarding the location of the distal portion 110d of the shaft 110.

[0048] The elastically deformable wire 150 may be made of Nitinol or stainless steel. The width of the elastically deformable wire 150 may be in the range of about 0.1 mm to 2 mm, for example 0.5 to 1 mm.

[0049] The elastically deformable wire 150 may be in a longitudinally expanded relaxed state or a longitudinally collapsed deformed state. The deformed state is a state in which an external force is applied to the elastically deformable wire 150. The relaxed state is a state in which an external force is not applied to the elastically deformable wire 150. In the relaxed state, i.e., when the elastically deformable wire 150 is not compressed, the elastically deformable wire 150 is in a longitudinally expanded relaxed state and supports the longitudinally expanded shape of the balloon 130 in the longitudinally expanded state 134a. In FIG. 6B, the balloon 130 is in the longitudinally expanded state 134a and the elastically deformable wire 150 is in a longitudinally expanded relaxed state. In the deformed state, i.e., when the elastically deformable wire 150 is compressed by the anchor 140 and the shape is restricted in a longitudinally collapsed state, the elastically deformable wire 150 is in a longitudinally collapsed deformed state.

[0050] The elastically deformable wire 150 may have a spring constant that varies along the length 150L of the elastically deformable wire 150. If the spring constant varies along the length 150L of the elastically deformable wire 150, then when the elastically deformable wire 150 is compressed longitudinally, the portions of the elastically deformable wire 150 with a lower spring constant will be compressed longitudinally before the portions of the elastically deformable wire 150 with a higher spring constant.

[0051] In some embodiments, the elastically deformable wire 150 may have a higher spring constant at the proximal end 150p of the elastically deformable wire 150 than the spring constant at the distal end 150d of the elastically deformable wire 150. If the spring constant at the proximal end 150p of the elastically deformable wire 150 is higher than the spring constant at the distal end 150d of the elastically deformable wire 150, when the wire is longitudinally compressed, the distal end 150d of the elastically deformable wire 150 is longitudinally compressed before the proximal end 150p of the elastically deformable wire 150 is longitudinally compressed. Longitudinally compressing the distal end 150d of the elastically deformable wire 150 prior to longitudinally compressing the proximal end 150p of the elastically deformable wire 150 facilitates preventing obstruction or blockage of the drug pathway through the balloon 130, which may reduce the flow of drug through the drug-eluting device 100. In other embodiments, the elastically deformable wire 150 may have a lower spring constant at the proximal end 150p of the elastically deformable wire 150 than the spring constant at the distal end 150d of the elastically deformable wire 150. In yet other embodiments, the elastically deformable wire 150 may have different spring constants at multiple points along the length 150L of the elastically deformable wire 150.

[0052] The distal end 150d of the elastically deformable wire 150 may be attached to the distal portion 130d of the balloon 130 via an anchor 140. The distal end 150d of the elastically deformable wire 150 may be attached to the anchor 140 by swaging or by other suitable connection configurations.

[0053] The elastically deformable wire 150 is within the balloon 130 as shown in Figures 6B-6C. Prior to the expansion of the balloon 130 to the longitudinally expanded state 134a, the elastically deformable wire 150 may be in a longitudinally contracted deformed state within the balloon 130. In the deformed state, the elastically deformable wire 150 is in a longitudinally contracted deformed state. After the balloon 130 is expanded to the longitudinally expanded state 134a, the elastically deformable wire 150 is in a longitudinally expanded, relaxed state. In the relaxed state, the elastically deformable wire 150 expands to a longitudinally expanded, relaxed state to support the longitudinally expanded state 134a of the balloon 130.

[0054] 6B, the elastically deformable wire 150 has a helical shape 150h. In the helical shape 150h, the elastically deformable wire 150 has a shape that is made up of a series of turns from a proximal end 150p of the elastically deformable wire 150 to a distal end 150d of the elastically deformable wire 150. The turns of the helical shape 150h may be circular, elliptical, or other rounded configurations.

[0055] 6C, the elastically deformable wire 150 has a straightened shape 150s. In the straightened shape 150s, the elastically deformable wire 150 includes a plurality of elastically deformable wire portions 152. The plurality of elastically deformable wire portions 152 extend from a proximal portion 130p of the balloon 130 to a distal portion 130d of the balloon 130 and are aligned along a longitudinal axis A of the shaft 110. L6C, the elastically deformable wire portions 152 are each shown to have a substantially similar width. However, in other embodiments, the elastically deformable wire portions 152 may have different widths. In FIG. 6C, the elastically deformable wire portions 152 include six elastically deformable wire portions 152. In other embodiments, the elastically deformable wire portions 152 may include one, two, three, four, five, six, seven, eight, nine, or more elastically deformable wire portions 152. When the elastically deformable wire 150 having a straight shape 150s is compressed longitudinally, the elastically deformable wire portions 152 are compressed radially outward in a direction RO relative to the longitudinal axis A of the shaft 110. L It deforms radially outward in the direction RO.

[0056] The drug eluting device 100 also includes a pull wire 128 (e.g., a thread, strand, line, filament, etc.). In FIG. 2A, the drug eluting device 100 includes two pull wires 128. In other embodiments, the drug eluting device 100 may include one, two, three, or more pull wires. In some embodiments, the pull wires 128 are located within the drug lumen 114 of the shaft 110. In other embodiments, the pull wires 128 are located within the pull wire lumen 118 of the shaft 110. In some embodiments, a single pull wire 128 may be located within the drug lumen 114 of the shaft 110. In other embodiments, multiple pull wires 128 may be located within the drug lumen 114 of the shaft 110. In some embodiments, a single pull wire 128 may be located within a single pull wire lumen 118 of the shaft 110. In other embodiments, multiple pull wires 128 may be located within a single pull wire lumen 118 of the shaft 110. The pull wire 128 is connected to an anchor 140. By connecting the pull wire 128 to the anchor 140, when the pull wire 128 is pulled, the anchor 140 is allowed to move proximally, compressing the balloon 130.

[0057] The pull wire 128 may be pulled by the actuator 108 when a user activates the actuator 108. Pulling the pull wire 128 causes the balloon 130 to change from a longitudinally expanded state 134a to a longitudinally compressed state 134b. In FIG. 1A, the balloon 130 is in the longitudinally expanded state 134a. In FIG. 1B, the balloon 130 is in the longitudinally compressed state 134b. As the balloon 130 changes from the longitudinally expanded state 134a to the longitudinally compressed state 134b, at least a portion of the drug that remained within the balloon 130 but has not yet exited the balloon 130 exits through the multiple holes 132 in the balloon 130 and enters the blood vessel.

[0058] 1A-1C, after the pull wire 128 is pulled to compress the balloon 130 to the longitudinally compressed state 134b, the elastically deformable wire 150 returns the balloon 130 to the longitudinally expanded state 134a. In FIG. 1A, during and / or after the balloon 130 is inflated by the drug to the longitudinally expanded state 134a, the elastically deformable wire 150 expands to support the longitudinally expanded state 134a of the balloon 130. After the actuator 108 is actuated to pull the pull wire 128 and move the anchor 140 in the proximal direction to compress the balloon 130 to the longitudinally compressed state 134b, in FIG. 1B, the elastically deformable wire 150 is also compressed by the anchor 140, so that the elastically deformable wire 150 is in a longitudinally contracted deformed state within the balloon 130. The actuator 108 is then deactivated, causing the pull wire 128 to stop pulling on the pull wire 128 and allowing the balloon 130 to regain its length as it returns to the longitudinally expanded state 134a, and the elastically deformable wire 150 can expand to support the longitudinally expanded state 134a of the balloon 130, as shown in Figure 1C. In a relaxed state, when the elastically deformable wire 150 is not compressed by the anchor 140 pulled by the pull wire 128, the elastically deformable wire 150 is in a longitudinally expanded, relaxed state.

[0059] In some embodiments, the drug eluting device 100 may be used with a long carrier tube 180 (discussed in more detail herein). In other embodiments, the drug eluting device 100 may be used with a short carrier tube 182 (discussed in more detail herein). In some embodiments, the drug eluting device 100 may be used with a long carrier tube 180 or a short carrier tube 182, where the carrier tube is configured to be attached to a guide catheter 184 (discussed in more detail herein).

[0060] Second embodiment 8A-12 show a drug-eluting device 200 (e.g., a therapeutic device) for delivering a drug (e.g., a drug including an anti-proliferative agent such as sirolimus) into a blood vessel according to a second embodiment. The drug-eluting device 200 includes a handle 206 having a drug port 204 configured to receive a drug. The drug-eluting device 200 further includes a shaft 210 connected to the handle 206. The shaft 210 includes a drug lumen 214 configured to receive a drug from the drug port 204 and a guidewire tube 216 configured to receive a guidewire 226, the guidewire 226 extending out of a distal portion 210d of the shaft 210. The drug-eluting device 200 further includes a carrier tube 260 connected to or connectable to the handle 206, the carrier tube 260 surrounding the shaft 210. The drug-eluting device 200 further includes a balloon 230 attached to the distal portion 210d of the shaft 210 and configured to receive the drug from the drug lumen 214, the balloon 230 including a plurality of holes 232 configured to allow the drug to exit the balloon 230. The handle 206 includes an actuator 208 that is user actuatable to pull the shaft 210 to draw the balloon 230 into the carrier tube 260 and change the balloon 230 from a radially expanded state 234a to a radially compressed state 234b. In some embodiments, the drug-eluting device 200 may further include a stop cock 202 connected to the drug port 204. In some embodiments, the drug-eluting device 200 extends from a proximal portion 230p of the balloon 230 to a distal portion 230d of the balloon 230 and is aligned with the longitudinal axis A of the shaft 210 when in a relaxed state. L 2. In some embodiments, the drug eluting device 200 may further include one or more elastically deformable wires 256 that are curved radially outward relative to the distal end portion 210d of the carrier tube 260. In some embodiments, the drug eluting device 200 may further include a ring 270 connected to the distal end portion 210d of the carrier tube 260. The elastic modulus of the material of the ring 270 is greater than the elastic modulus of the material of the carrier tube 260.

[0061] The drug eluting device 200 includes a handle 206 (e.g., a grip, hand grip, etc.). The handle 206 is configured similarly to handle 106. The handle 206 includes a body 207 (e.g., a shell, housing, container, etc.) configured similarly to body 107. In FIG. 9B, the handle 206 also includes a hub 201 configured similarly to hub 101. The hub 201 includes a drug port 204 (e.g., a hole, an opening, an aperture, etc.) configured similarly to drug port 104. The handle 206 may also include a stop cock 202 (e.g., a valve, etc.) configured similarly to stop cock 102.

[0062] The handle 206 also includes an actuator 208 (e.g., a tab, button, wheel, knob, etc.). The actuator 208 may be a mechanical structure that is operable by a user to manipulate the drug-eluting device 200. The actuator 208 rotates in either a clockwise or counterclockwise direction about the length of the handle 206 relative to the longitudinal axis A. L 9A , the actuator 208 is actuated by rotating the shaft 210 in a direction parallel to the handle 206. Actuation of the actuator 208 pulls the shaft 210 proximally, drawing the balloon 230 into the carrier tube 260, radially compressing the balloon 230, and expelling the agent from the plurality of holes 232 in the balloon 230. In FIG. 9A , the actuator 208 is located at the top of the handle 206. However, in other embodiments, the actuator 208 may be located at the bottom, left, or right side of the handle 206.

[0063] The drug-eluting device 200 also includes a shaft 210 (e.g., a catheter, a tube, a pipe, a cylinder, a conduit, etc.). The shaft 210 is connected to the handle 206. The shaft 210 may be connected to the handle 206 by an adhesive bond, an interlocking mechanism, a press fit, a threaded fastener, or other suitable connection configuration. The shaft 210 may be permanently fixed to the handle 206 such that a user cannot remove the shaft 210 from the handle 206.

[0064] The shaft 210 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, fluoroplastic, or other suitable material.

[0065] The length of the shaft 210 is in the range of about 30 to 300 cm, for example, 30 to 200 cm.

[0066] The cross-sectional shape of shaft 210 may be circular, elliptical, polygonal, rounded polygonal, or other geometric shape. The maximum cross-sectional width of shaft 210 (e.g., diameter when the cross-sectional shape is circular) is in the range of about 0.5 to 10 mm (inclusive), and ideally is 0.5 to 7 mm.

[0067] 10A-10C show right side views of a portion of drug-eluting device 200. Drug-eluting device 200 may be a rapid exchange type device, in which case guidewire 226 enters shaft 210 at a location on shaft 210 distal to where shaft 210 is connected to handle 206. In other embodiments, drug-eluting device 200 is an over-the-wire type device, in which case guidewire 226 enters shaft 210 through handle 206. Guidewire tube 216, configured to receive guidewire 226, extends longitudinally through a portion of the length of shaft 210.

[0068] Shaft 210 includes an agent lumen 214 (e.g., a cavity, space, etc.) and a guidewire tube 216 (e.g., a pipe, a cylinder, a conduit, etc.). Agent lumen 214 is constructed similarly to agent lumen 114. Guidewire tube 216 is constructed similarly to guidewire tube 116.

[0069] The drug-eluting device 200 also includes a carrier tube 260 (e.g., a sheath, a guide sheath, a cover, etc.). In FIGS. 8A-8D, the carrier tube 260 is connected to the handle 206. In other embodiments, the carrier tube 260 may not be connected to the handle 206. The carrier tube 260 is configured to surround the shaft 210 such that the shaft 210 extends longitudinally through the carrier tube 260. The carrier tube 260 may be connected to the handle 206 by a luer lock connector, a lock connector, a fitting connector, or other suitable connection configuration. The carrier tube 260 may be secured to the handle 206 such that a user cannot remove the carrier tube 260 from the handle 206.

[0070] 8A-8D, carrier tube 260 may be a long carrier tube 180 (discussed in more detail herein). In other embodiments, carrier tube 260 may be a short carrier tube 182 (discussed in more detail herein). In some embodiments, carrier tube 260 is configured to be attached to a guide catheter 184 (discussed in more detail herein).

[0071] The carrier tube 260 may be made from 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.

[0072] The length of the carrier tube 260 is in the range of about 30 cm to 300 cm, for example, 30 cm to 200 cm.

[0073] The cross-sectional shape of the carrier tube 260 may be circular, elliptical, polygonal, rounded polygonal, or other geometric shape. The maximum cross-sectional width of the carrier tube 260 (e.g., diameter when the cross-sectional shape is circular) may be in the range of about 1 mm to 15 mm (inclusive), such as 2 mm to 8 mm. The wall thickness of the carrier tube 260 may be in the range of about 0.1 mm to 1 mm (inclusive).

[0074] Drug-eluting device 200 also includes a balloon 230. Balloon 230 is configured similarly to balloon 130. However, when drug enters balloon 230 from drug lumen 214, balloon 230 expands to a radially expanded state 234a as compared to longitudinally expanded state 134a of balloon 130. Balloon 230 includes a plurality of holes 232 (e.g., restrictions, openings, slits, etc.) configured similarly to the plurality of holes 132 of balloon 130.

[0075] The actuator 208, which is actuable by a user to pull on the shaft 210, draws the balloon 230 into the carrier tube 260, thereby changing the balloon 230 from a radially expanded state 234a to a radially compressed state 234b. As the balloon 230 is drawn into the carrier tube 260, the balloon is radially compressed relative to the carrier tube 260. Radially compressing the balloon 230 relative to the carrier tube 260 compresses the balloon 230, which allows for a smooth compression action, and at least a portion of the drug remaining within the balloon 230 is expelled from the balloon 230 through the plurality of holes 232 as the balloon 230 changes from the radially expanded state 234a to the radially compressed state 234b.

[0076] The drug-eluting device 200 may further include one or more elastically deformable wires 256 (e.g., threads, strands, lines, filaments, etc.), which extend from the proximal portion 230p of the balloon 230 to the distal portion 230d of the balloon 230 and are aligned with the longitudinal axis A of the shaft 210 when the one or more elastically deformable wires 256 are in a relaxed state.L The elastically deformable wires 256 are bent radially outward relative to the carrier tube 260. The deformed state is a state in which an external force is applied to the elastically deformable wire(s) 256, and the relaxed state is a state in which no external force is applied to the elastically deformable wire(s) 256. When in the relaxed state, i.e., when the elastically deformable wire(s) 256 are located outside the carrier tube 260, the elastically deformable wire(s) 256 are in a radially expanded relaxed state to support the radially expanded state 234a of the balloon 230. When in the deformed state, i.e., when the elastically deformable wire(s) 256 are located inside the carrier tube 260 and are limited in expansion by the carrier tube 260, the elastically deformable wire(s) 256 are in a radially contracted deformed state. During and / or after the balloon 230 is inflated to the radially expanded state 234a, the elastically deformable wire(s) 256 change from the radially contracted deformed state to the radially expanded relaxed state. In Figures 11A-11B, the drug eluting device 200 includes three elastically deformable wires 256. In Figure 12, the drug eluting device 200 includes six elastically deformable wires 256. In other embodiments, the drug eluting device 200 may have one, two, three, four, five, six or more elastically deformable wires 256.

[0077] The elastically deformable wire(s) 256 may be made of Nitinol or stainless steel. The width of the elastically deformable wire(s) 256 may be in the range of about 0.1-2 mm inclusive, for example 0.3-1 mm. In Figures 11A-11B and 12, the width of the elastically deformable wire(s) 256 is the same. However, in other embodiments, the width of the elastically deformable wire(s) 256 may be different.

[0078] 11A-11B and 12, the one or more elastically deformable wires 256 are spaced at regular intervals around the balloon 230. However, in other embodiments, the one or more elastically deformable wires 256 may be spaced at different intervals around the balloon 230.

[0079] The drug-eluting device 200 may further include a ring 270 (e.g., a hoop, band, disc, etc.). In Figures 11A-11B, the ring 270 is connected to the distal portion 260d of the carrier tube 260. The ring 270 may be connected to the distal portion 260d of the carrier tube 260 by welding, braiding, press fitting, swaging, or other suitable connection configuration. The maximum cross-sectional width of the ring 270 is in the range of about 1-15 mm (inclusive), for example, 3-8 mm.

[0080] The elastic modulus of the material of the ring 270 is greater than the elastic modulus of the material of the carrier tube 260. Because the elastic modulus of the material of the ring 270 is greater than the elastic modulus of the material of the carrier tube 260, the ring 270 can provide stronger resistance to the balloon 230 as the balloon 230 is pulled into the carrier tube 260, and the ring 270 provides a greater amount of compression to the balloon 230 compared to when the ring 270 is not present, allowing for a smoother compression action of the balloon 230.

[0081] The ring 270 may be made of gold, platinum, stainless steel, tungsten, tantalum, or other suitable material. The ring 270 may be made of a radiopaque material. When the ring 270 is made of a radiopaque material, the ring 270 may be imaged using an imaging modality, such as x-ray, fluoroscopy, or other suitable imaging modality. The radiopaque material of the ring 270 facilitates detection and tracking of the distal portion 260d of the carrier tube 260 by imaging when the distal portion 260d of the carrier tube 260 is within a blood vessel. Such detection and tracking of the ring 270 may improve the manipulation and positioning of the drug-eluting device 200 within a blood vessel and improve targeting of a portion of the blood vessel location, since a user may have information about where the distal portion 260d of the carrier tube 260 is located through knowledge of the location of the ring 270 by imaging.

[0082] 8A-8D and 10A-10C, in one embodiment, the drug-eluting device 200 includes a carrier tube 260 but does not include one or more elastically deformable wires 256 or rings 270. In FIG. 8A, in one configuration, the shaft 210 and carrier tube 260 may be inserted into a blood vessel such that the distal portion 210d of the shaft 210 is proximal to the distal portion 260d of the carrier tube 260. In FIG. 8B, in another configuration, the shaft 210 and carrier tube 260 may be inserted into a blood vessel such that the distal portion 210d of the shaft 210 is distal to the distal portion 260d of the carrier tube 260. Whereas in the configuration of Figure 8A the distal portion 210d of shaft 210 is proximal to the distal portion 260d of carrier tube 260, in the configuration of Figure 8B the distal portion 210d of shaft 210 may be moved distally such that the distal portion 210d of shaft 210 is distal to the distal portion 260d of carrier tube 260. In Figures 8C and 10A, balloon 230 may be inflated with a drug such that balloon 230 is in a radially expanded state 234a and the drug exits balloon 230 through a plurality of holes 232 in balloon 230. 8D and 10B-10C, actuator 208 is actuated to pull shaft 210, drawing proximal portion 230p of balloon 230 into carrier tube 260 and compressing balloon 230 to radially compressed state 234b, causing at least a portion of the drug remaining in radially expanded state 234a of balloon 230 to exit balloon 230 through multiple holes 232.

[0083] In another embodiment, the drug-eluting device 200 includes a carrier tube 260 and one or more elastically deformable wires 256, but does not include a ring 270. The balloon 230 is inflated with a drug to a radially expanded state 234a, which allows the drug to exit the balloon 230 through the plurality of holes 232 and enter the blood vessel. The actuator 208 is actuated to pull the shaft 210, compressing the balloon 230 to a radially compressed state 234b, which causes the balloon 230 to be drawn into the carrier tube 260. The balloon 230 is drawn into the carrier tube 260, which causes the balloon 230 to be radially compressed, which causes at least a portion of the drug remaining within the balloon 230 to exit through the plurality of holes 232 in the balloon. The actuator 208 is actuated to pull the shaft 210, which radially compresses the balloon 230 to a radially compressed state 234b, which causes the one or more elastically deformable wires 256 to be compressed, which also causes the balloon 230 to be radially compressed. Pulling on one or more elastically deformable wires 256 as the balloon 230 is pulled into the carrier tube 260 applies additional radial compression to the balloon 230 compared to an embodiment in which the one or more elastically deformable wires 256 are not present, thereby causing at least a portion of the drug remaining within the balloon 230 to be expelled through the multiple holes 232 in the balloon 230.

[0084] In another embodiment, the drug-eluting device 200 includes the carrier tube 260 and the ring 270, but does not include the one or more elastically deformable wires 256. The balloon 230 is inflated with a drug to a radially expanded state 234a, whereby the drug exits the plurality of holes 232 in the balloon 230 and enters the blood vessel. The actuator 208 is actuated to pull the shaft 210, whereby the balloon 230 is radially compressed to a radially compressed state 234b, whereby the balloon 230 is retracted into the carrier tube 260. The retraction of the balloon 230 into the carrier tube 260 radially compresses the balloon 230, whereby at least a portion of the drug remaining in the balloon 230 is expelled from the plurality of holes 232 in the balloon. The actuator 208 is actuated to pull the shaft 210, whereby the balloon 230 is radially compressed to a radially compressed state 234b, whereby the balloon 230 is retracted into the carrier tube 260 and ring 270. Retracting the balloon 230 into the carrier tube 260 and the ring 270 exerts additional radial compression on the balloon 230 compared to an embodiment in which the ring 270 is not present, thereby causing at least a portion of the drug remaining within the balloon 230 to be expelled through the multiple holes 232 in the balloon 230.

[0085] 11A-11B, in one embodiment, the drug-eluting device 200 includes a carrier tube 260, one or more elastically deformable wires 256, and a ring 270. In FIGS. 11A-11B, the balloon 230 is inflated with the drug to a radially expanded state 234a, which allows the drug to exit the plurality of holes 232 in the balloon 230 and enter the blood vessel. In FIG. 11B, the actuator 208 is actuated to pull the shaft 210, radially compressing the balloon 230 to a radially compressed state 234b, which causes the balloon 230 to be drawn into the carrier tube 260 and ring 270. The actuator 208 is actuated to pull the shaft 210, radially compressing the balloon 230 to a radially compressed state 234b, which also compresses the one or more elastically deformable wires 256, which causes the balloon 230 to be radially compressed. Pulling the balloon 230 into the carrier tube 260 and ring 270 while simultaneously pulling the one or more elastically deformable wires 256 exerts additional radial compression on the balloon 230 compared to embodiments in which only the ring 270 or only the one or more elastically deformable wires 256 are present, thereby causing any drug remaining within the balloon 230 to be expelled through the multiple holes 232 in the balloon 230.

[0086] Third embodiment 13A-14B show a drug-eluting device 300 (e.g., a therapeutic device, etc.) for delivering a drug (e.g., a drug including an anti-proliferative agent such as sirolimus) into a blood vessel according to a third embodiment. The drug-eluting device 300 includes a handle 306 having a drug port 304 configured to receive a drug. The drug-eluting device 300 further includes a shaft 310 connected to the handle 306. The shaft 310 includes a drug lumen 314 configured to receive a drug from the drug port 304, and a guidewire tube 316 configured to receive a guidewire 326, the guidewire 326 extending out of a distal portion 310d of the shaft 310. The drug-eluting device 300 further includes a balloon 330 attached to the distal portion 310d of the shaft 310 and configured to receive a drug from the drug lumen 314, the balloon 330 including a plurality of holes 332 configured to allow the drug to exit the balloon 330. The drug eluting device 300 further includes an anchor 340 connected to the distal portion 330d of the balloon 330. The drug eluting device 300 further includes a pull wire 328 connected to the anchor 340. The handle 306 includes an actuator 308 that is user actuatable to change the balloon 330 from a longitudinally expanded state 334a to a longitudinally compressed state 334b ​​by pulling the pull wire 328. The longitudinally compressed state 334b ​​of the balloon is an inverted state 334c. In some embodiments, the drug eluting device 300 may further include a stop cock 302 connected to the drug port 304. In some embodiments, the shaft 310 may further include a pull wire lumen 318, the pull wire 328 being located within the pull wire lumen 318 of the shaft 310.

[0087] The drug eluting device 300 includes a handle 306 (e.g., a grip, hand grip, etc.). The handle 306 is configured similarly to the handle 106 of FIGS. 2A-2B. The handle 306 includes a body 307 (e.g., a shell, housing, container, etc.) configured similarly to the body 107. The handle 306 also includes a hub 301 configured similarly to the hub 101 of FIG. 2C. The hub 301 includes a drug port 304 (e.g., a hole, an opening, an aperture, etc.) configured similarly to the drug port 104. The handle 306 also includes an actuator 308 (e.g., a tab, a button, a wheel, a knob, etc.) configured similarly to the actuator 108. The handle 306 also includes a stop cock 302 (e.g., a valve, etc.) configured similarly to the stop cock 102.

[0088] Drug eluting device 300 also includes a shaft 310 (eg, a catheter, tube, pipe, cylinder, conduit, etc.) configured similarly to shaft 110.

[0089] The drug eluting device 300 may be a rapid exchange type device configured similarly to the drug eluting device 100, as shown in Figure 3. In other embodiments, the drug eluting device 300 may be an over-the-wire type device in which a guidewire 326 passes through the handle 306 and into the shaft 310.

[0090] Shaft 310 includes an agent lumen 314 (e.g., a cavity, space, etc.) configured similarly to agent lumen 114. In some embodiments, shaft 310 also includes a pullwire lumen 318 (e.g., a cavity, space, etc.) configured similarly to pullwire lumen 118. Shaft 310 also includes a guidewire tube 316 (e.g., a pipe, cylinder, conduit, etc.) configured similarly to guidewire tube 116. Agent lumen 314, pullwire lumen 318, and guidewire tube 316 may be configured similarly to agent lumen 114, pullwire lumen 118, and guidewire tube 116 of FIGS. 4A-4C and 5A-5C.

[0091] Drug-eluting device 300 also includes a balloon 330 that is configured similarly to balloon 130. Balloon 330 includes a plurality of holes 332 (e.g., restrictions, openings, slits, etc.) that are configured similarly to the plurality of holes 132 in balloon 130.

[0092] Drug eluting device 300 also includes anchor 340 (eg, a block, weight, cap, etc.) configured similarly to anchor 140.

[0093] Drug eluting device 300 also includes a pullwire 328 (eg, a thread, strand, line, filament, etc.) configured similarly to pullwire 128.

[0094] The pull wire 328 may be pulled by the actuator 308 when the user activates the actuator 308. Pulling the pull wire 328 changes the balloon 330 from a longitudinally expanded state 334a to a longitudinally compressed state 334b, which is an inverted state 334c. In the inverted state 334c, the distal portion 330d of the balloon 330 is pulled in the proximal direction, which changes the distal portion 330d of the balloon from a concave shape to a convex shape. In Figures 13B and 14A-14B, the balloon 330 is in the longitudinally expanded state 334a. In Figure 13C, the balloon 330 is in the longitudinally compressed state 334b, which is an inverted state 334c. When the balloon 330 changes from the longitudinally expanded state 334a to the longitudinally compressed state 334b, i.e., the inverted state 334c, at least a portion of the drug that remained within the balloon 330 but has not yet exited the balloon 330 exits the multiple holes 332 in the balloon 330 and enters the blood vessel.

[0095] 13A-13C, drug-eluting device 300 includes an anchor 340 connected to a distal portion 330d of balloon 330, which is connected to a pull wire 328 such that longitudinally compressed state 334b ​​of balloon 330 is inverted state 334c. Balloon 330 may be inflated with a drug to longitudinally expanded state 334a of FIG. 13B. Actuator 308 is then actuated to pull pull wire 328, tensioning anchor 340 and compressing balloon 330, thereby causing balloon 330 to assume longitudinally compressed state 334b, or inverted state 334c of FIG. 13C. As the balloon 330 transitions from the longitudinally expanded state 334a of FIG. 13B to the longitudinally compressed state 334b ​​and inverted state 334c of FIG. 13C, the distal portion 330d of the balloon 330 is pulled proximally via the anchor 340, causing the distal portion 330d of the balloon 330 to move proximally past another portion of the balloon 330. The balloon 330 may be made of a flexible material, whereby as the distal portion 330d of the balloon 330 is pulled by the pull wire 328 via the anchor 340, the balloon 330 transitions to the inverted state 334c of FIG. 13C rather than the longitudinally compressed state 134b of FIG. 1B. As the balloon 330 transitions from the longitudinally expanded state 334a to the inverted state 334c, at least a portion of the agent remaining within the balloon 330 is expelled from the balloon 330 through the plurality of holes 332.

[0096] In some embodiments, the drug eluting device 300 may be used with a long carrier tube 180 (discussed in more detail herein). In other embodiments, the drug eluting device 300 may be used with a short carrier tube 182 (discussed in more detail herein). In some embodiments, the drug eluting device 300 may be used with a long carrier tube 180 or a short carrier tube 182 (which are configured to be attached to a guide catheter 184 (discussed in more detail herein)).

[0097] Fourth embodiment 15A-16 show a drug-eluting device 400 (e.g., a therapeutic device, etc.) for delivering a drug (e.g., a drug including an anti-proliferative agent such as sirolimus) into a blood vessel according to a fourth embodiment. The drug-eluting device 400 includes a handle 406 having a drug port 404 configured to receive a drug. The drug-eluting device 400 further includes a first shaft 410 connected to the handle 406, the first shaft 410 including a drug lumen 414 further configured to receive a drug from the drug port 404. The drug-eluting device 400 further includes a second shaft 412 connected to the handle 406, the second shaft 412 extending through the first shaft 410 and configured to move independently of the first shaft 410. The second shaft 412 is configured to receive a guidewire 426 and to allow the guidewire 426 to extend out of a distal portion 412d of the second shaft 412. The drug-eluting device 400 further includes a balloon 430 including a proximal portion 430p connected to the distal portion 410d of the first shaft 410 and a distal portion 430d connected to the distal portion 412d of the second shaft 412. The balloon 430 is configured to receive the drug from the drug lumen 414, and the balloon 430 has a plurality of holes 432 configured to allow the drug to exit the balloon 430. The actuator 408 is actuated by a user to rotate the second shaft 412 relative to the first shaft 410, thereby changing the balloon 430 from a radially expanded state 434a to a radially compressed state 434b. In some embodiments, the drug-eluting device 400 may further include a stop cock 402 connected to the drug port 404.

[0098] The drug-eluting device 400 includes a handle 406 (e.g., a grip, a hand grip, etc.) that is configured to be grasped by a user and allows the user to manipulate the drug-eluting device 400. The handle 406 may be configured to be grasped in one hand to allow the user to perform additional manipulations with the other hand.

[0099] Handle 406 includes a body 407 (eg, a shell, housing, container, etc.) that is configured similarly to body 107 .

[0100] The drug eluting device 400 includes a hub 401. In FIG. 15, the hub 401 is separate from the handle 406 and is connected to a first shaft 410. The hub 401 may be connected to the first shaft 410 by adhesive or other suitable connection configuration. However, in other embodiments, the hub 401 may be located on the top, bottom, left, right, or proximal side of the handle 406. The hub 401 includes a drug port 404 (e.g., a hole, an opening, a restriction, etc.) configured similarly to the drug port 104. The hub 401 may also include a stop cock 402 (e.g., a valve, etc.) configured similarly to the stop cock 102.

[0101] The handle 406 also includes an actuator 408 (e.g., a tab, button, wheel, knob, etc.). The actuator 408 is a mechanical structure that is operable by a user to operate the drug-eluting device 400. The actuator 408 rotates in either a clockwise or counterclockwise direction about the length of the handle 406 relative to the longitudinal axis A. L 15. The actuator 408 is actuated by rotating the actuator 408 in a direction parallel to the first shaft 410. Rotation of the actuator 408 results in rotation of the second shaft 412 relative to the first shaft 410, radially compressing the balloon 430 and expelling the drug from the multiple holes 432 in the balloon 430. In FIG. 15, the actuator 408 is located at the top of the handle 406. However, in other embodiments, the actuator 408 may be located at the bottom, left, or right side of the handle 406.

[0102] The drug-eluting device 400 also includes a first shaft 410 (e.g., a catheter, a tube, a pipe, a cylinder, a conduit, etc.). The first shaft 410 is connected to a handle 406. The first shaft 410 may be connected to the handle 406 by adhesive bonding or other suitable connection configuration. The first shaft 410 may be permanently fixed to the handle 406 such that a user cannot remove the first shaft 410 from the handle 406.

[0103] 16, the drug eluting device 400 may be an over-the-wire type device in which a guidewire 426 passes through the handle 406 and into the second shaft 412. In other embodiments, the drug eluting device 400 may be a rapid exchange type device.

[0104] The first shaft 410 may be made from a fluoropolymer (e.g., polytetrafluoroethylene (PTFE)), ethylene / tetrafluoroethylene copolymer (ETFE), polyetheretherketone (PEEK), polyurethane, polyamide elastomer, polyester elastomer, polyurethane elastomer, polyimide, polycarbonate, polyetherimide, fluoroplastic, or other suitable material.

[0105] The length of the first shaft 410 may be in the range of about 30-300 cm, for example, 30-200 cm. The cross-sectional shape of the first shaft 410 may be circular, elliptical, polygonal, rounded polygonal, or have other geometric shapes. The maximum cross-sectional width of the first shaft 410 (e.g., the diameter when the cross-sectional shape is circular) may be in the range of about 1-15 mm (inclusive), for example, 2-8 mm.

[0106] The first shaft 410 is configured to receive a drug from the drug port 404. The first shaft 410 has a drug lumen 414 (e.g., a cavity, a space, etc.). The drug lumen 414 extends longitudinally through the first shaft 410. The drug lumen 414 is configured to receive a drug from the drug port 404.

[0107] The cross-sectional shape of the drug lumen 414 may be circular, elliptical, polygonal, rounded polygonal, or other geometric shape. The maximum cross-sectional width of the drug lumen 414 (e.g., diameter when the cross-sectional shape is circular) may be in the range of about 0.5-10 mm (inclusive), and ideally 0.5-7 mm.

[0108] The drug eluting device 400 also includes a second shaft 412 (e.g., a catheter, a tube, a pipe, a cylinder, a conduit, etc.). The second shaft 412 is connected to the actuator 408. The second shaft 412 may be connected to the actuator 408 by an adhesive bond, an interlocking mechanism, a weld, a press fit, a threaded fastener, or other suitable connection configuration. The second shaft 412 may be permanently fixed to the actuator 408 such that a user cannot remove the second shaft 412 from the actuator 408. A portion of the second shaft 412 is positioned within the handle 406 such that the second shaft 412 is aligned with the longitudinal axis A of the first shaft 410. L 4, the first shaft 410 is moved in a direction parallel to the longitudinal axis A L may rotate around

[0109] The second shaft 412 passes through the first shaft 410 and is configured to move independently of the first shaft 410. The second shaft 412 is configured such that a distal portion 412d of the second shaft 412 can be positioned distal to a distal portion 410d of the first shaft 410. The second shaft 412 is configured to receive a guidewire 426 and to allow the guidewire 426 to extend out of the distal portion 412d of the second shaft 412.

[0110] The second shaft 412 may be made from a fluoropolymer (e.g., polytetrafluoroethylene (PTFE)), ethylene / tetrafluoroethylene copolymer (ETFE), polyetheretherketone (PEEK), polyurethane, polyamide elastomer, polyester elastomer, polyurethane elastomer, polyimide, polycarbonate, polyetherimide, fluoroplastic, or other suitable material.

[0111] The length of the second shaft 412 may be in the range of about 30-300 cm, for example, 30-200 cm. The cross-sectional shape of the second shaft 412 may be circular, elliptical, polygonal, rounded polygonal, or have other geometric shapes. The maximum cross-sectional width of the second shaft 412 (e.g., diameter when the cross-sectional shape is circular) may be in the range of about 0.1-10 mm (inclusive), for example, 0.5-3 mm.

[0112] The drug-eluting device 400 also includes a balloon 430. The balloon 430 has a proximal portion 430p attached to the distal portion 410d of the first shaft 410. The balloon 430 has a distal portion 430d attached to the distal portion 412d of the second shaft 412. The balloon 430 may be attached to the distal portion 410d of the first shaft 410 and may be disposed over the distal portion 410d of the first shaft 410 and the distal portion 412d of the second shaft 412 and attached to the distal portion 412d of the second shaft 412 by adhesive bonding or other suitable connection configuration. In some embodiments, the proximal portion 430p of the balloon 430 may be attached to the distal portion 410d of the first shaft 410 in the same connection configuration as the distal portion 430d of the balloon 430 may be attached to the distal portion 412d of the second shaft 412. In other embodiments, the base end portion 430p of the balloon 430 may be attached to the tip portion 410d of the first shaft 410 in a different connection configuration than the tip portion 430d of the balloon 430 may be attached to the tip portion 412d of the second shaft 412.

[0113] The balloon 430 is configured to receive the agent from the agent lumen 414 of the first shaft 410. When the agent enters the balloon 430 from the agent lumen 414, the balloon 430 expands to a radially expanded state 434a and the agent exits the balloon 430 through a plurality of holes 432 in the balloon 430.

[0114] The balloon 430 may be made of polyamide, polyester, polyurethane, polyamide elastomer, polyester elastomer, polyurethane elastomer, or other suitable material.

[0115] The length of the balloon 430 may be in the range of about 10 to 300 mm, for example, 10 to 50 mm, or 15 to 40 mm, and the width of the balloon 430 may be in the range of about 1 to 8 mm, for example, 2 to 5 mm, or 4 to 8 mm.

[0116] The balloon 430 includes a number of holes 432 (e.g., apertures, openings, slits, etc.) configured to allow the agent to exit the balloon 430. The number of holes 432 in the balloon 430 are configured similarly to the number of holes 132 in the balloon 130. When the balloon 430 is in a radially expanded state 434a, the agent passes through the number of holes 432 in the balloon 430, exits the balloon 430 and enters the blood vessel.

[0117] The actuator 408 may rotate when a user activates the actuator 408. Rotating the actuator 408 rotates the distal portion 412d of the second shaft 412. As the second shaft 412 rotates relative to the first shaft 410, the first shaft 410 may be held in a fixed position. The second shaft 412 may rotate clockwise or counterclockwise. As the second shaft 412 rotates relative to the first shaft 410, the balloon 430 changes from a radially expanded state 434a to a radially compressed state 434b. In FIG. 15A, the balloon 430 is in the radially expanded state 434a. In FIG. 15B, the balloon 430 is in the radially compressed state 434b. When the balloon 430 is radially compressed from the radially expanded state 434a to the radially compressed state 434b, at least a portion of the drug that remained within the balloon 430 but has not yet exited the balloon 430 exits the multiple holes 432 in the balloon 430 and enters the blood vessel.

[0118] In some embodiments, the drug eluting device 400 may be used with a long carrier tube 180 (discussed in more detail herein). In other embodiments, the drug eluting device 400 may be used with a short carrier tube 182 (discussed in more detail herein). In some embodiments, the drug eluting device 400 is used with a long carrier tube 180 or a short carrier tube 182, which are configured to be attached to a guide catheter 184 (discussed in more detail herein).

[0119] General Operation of Drug Elution Devices and Long and Short Carrier Tubes 17A-19D show the drug eluting device in various operational configurations 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 apparatus.

[0120] The drug eluting devices 100, 200, 300, and 400 can be used with a needle for insertion into a subject. The needle can be used to create a hole in the subject that provides access to a blood vessel. The blood vessel accessed by the needle can be the blood vessel targeted for drug elution or can be a blood vessel into which the drug eluting devices 100, 200, 300, and 400 can be pushed to reach another blood vessel targeted for drug elution. In other embodiments, a trocar can be used to create a hole in the subject that provides access to a blood vessel.

[0121] After the needle accesses the blood vessel, a guidewire (which may be guidewire 126, 226, 326, or 426) may be inserted through the needle into the blood vessel and positioned at or near the target for drug elution. Imaging may be used to aid in positioning 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, 200, 300, or 400 into the subject. The guidewire is then withdrawn from the blood vessel, with the components that passed over the guidewire remaining within the blood vessel. In other embodiments, the guidewire may remain within the blood vessel, and the guidewire is withdrawn after the drug eluting device 100, 200, 300, or 400 is used and withdrawn.

[0122] Drug eluting devices 100, 200, 300, and 400 may be used with a guide catheter 184 (e.g., a catheter, shaft, tube, pipe, cylinder, conduit, etc.). Guide catheter 184 is passed over a guidewire and inserted into a blood vessel. Guide catheter 184 may be positioned at or near a target for drug elution. Shaft 110 and balloon 130, shaft 210 and balloon 230, shaft 310 and balloon 330, or first shaft 410, second shaft 412, and balloon 430 may pass through guide catheter 184.

[0123] The use of guide catheter 184 allows balloon 130, 230, 330 or 430 to be advanced within the blood vessel without encountering calcification, plaque, or other material within the vessel that may impede the advancement of balloon 130, 230, 330 or 430 if encountered without guide catheter 184. When guide catheter 184 is used, retracting balloon 130, 230, 330 or 430 into guide catheter 184 causes the balloon to be retracted through guide catheter 184, radially compressing the balloon because guide catheter 184 is distal to long carrier tube 180 or short carrier tube 182.

[0124] 17A-19D show a drug eluting device including 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.). FIG. 17A-19D shows a drug eluting device 200. In other embodiments, the drug eluting device 100, 300, or 400 may be used as the drug eluting device of FIG. 17A-19D. In some embodiments, the length of the long carrier tube 180 (which may be carrier tube 260) is equal to or longer than the length of the shaft (which may be shaft 210). In other embodiments, the length of the long carrier tube 180 that may be used with the drug eluting device 100, 300, or 400 is equal to or longer than the length of the shaft (which may be shaft 110, shaft 210, or first shaft 410). In some embodiments, the length of the short carrier tube 182 (which may be carrier tube 260) is in the range of about 100-120%, preferably 110%, of the length of the balloon 230. In other embodiments, the length of the short carrier tube 182 that may be used with the drug-eluting device 100, 300, or 400 is in the range of about 100-120%, preferably 110%, of the length of the balloon (which may be balloon 130, 330, or 430). Both the long carrier tube 180 and the short carrier tube 182 may be used with a guide catheter 184.

[0125] 17A-17D show a drug eluting device including a short carrier tube 182 and a guide catheter 184. The short carrier tube 182 can be connected to the guide catheter 184 such that the shaft 110, 210, 310, or the first shaft 410 and the second shaft 412 first pass through the short carrier tube 182 and then through the guide catheter 184. The short carrier tube 182 can 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 can be connected to a handle (which may be the handle 106, 206, 306, or 406) by a luer lock connector, a lock connector, a fitting connector, or other suitable connection configuration. In the configuration of FIG. 17A, the short carrier tube 182 is not connected to the handle 206. In the configuration of FIG. 17B-17D, the short carrier tube 182 is connected to the handle 206.

[0126] The use of a short carrier tube 182 and guide catheter 184 allows the balloon (which may be balloon 130, 230, 330, or 430) to be protected during balloon insertion and allows the balloon to be primed before being inserted directly into the guide catheter 184, preventing air from being trapped in the guide catheter 184. The use of a short carrier tube 182 allows for easier transfer of the balloon into the guide catheter 184.

[0127] In Figures 17A-17D, a short carrier tube 182 is shown with the drug-eluting device 200. In Figure 17A, the balloon 230 and shaft 210 are positioned within the short carrier tube 182. In Figure 17B, the balloon 230 and shaft 210 are pushed through the short carrier tube 182 and into the guide catheter 184. When the balloon 230 is within the guide catheter 184, the balloon 230 is in a deformed state of radial compression 234b. In Figure 17C, the balloon 230 and shaft 210 are pushed forward and the balloon 230 is completely outside the guide catheter 184. In Figure 17C, the balloon 230 is inflated and the balloon 230 is in a radially expanded state 234a. After the drug is delivered, the balloon 230 and shaft 210 are pulled back and the balloon 230 is either inside the guide catheter 184 as in Figure 17B or within the short carrier tube 182 as in Figure 17A. 17D, balloon 230 and shaft 210 have been retracted, with balloon 230 partially inside guide catheter 184. Retracting shaft 210 compresses balloon 230 against guide catheter 184, thereby radially compressing balloon 230.

[0128] In other embodiments, the short carrier tube 182 of Figures 17A-17D may be used with the drug eluting devices 100, 300, or 400. Figures 17A-17D show an over-the-wire type device. In other embodiments, the short carrier tube 182 of Figures 17A-17D may be used with a rapid exchange type device. When the short carrier tube 182 is used with a rapid exchange type device and the guide catheter 184, the guidewire 126, 226, 336, or 436 is positioned next to the shaft 110, 210, 310, or the first shaft 410 and second shaft 412, and inside the guide catheter 184.

[0129] In Figures 18A-18C, the long carrier tube 180 is shown with the drug eluting device 200. The long carrier tube 180 is connected to the handle 206 and may be connected by a luer lock connector, a lock connector, a fitting connector, or other suitable connection configuration. In Figure 18A, the balloon 230 is positioned within the long carrier tube 180. In Figure 18B, the balloon 230 has been pushed forward so that the balloon 230 is completely outside the long carrier tube 180. In Figure 18B, the balloon 230 is in an inflated, radially expanded state 234a. In Figure 18C, the balloon 230 has been pulled back so that the balloon 230 is partially inside the long carrier tube 180. After the drug has been delivered, the balloon 230 may be pulled back so that the balloon 230 is inside the long carrier tube 180, as in Figure 18A.

[0130] In other embodiments, the long carrier tube 180 of Figures 18A-18C may be used with the drug eluting device 100, 300, or 400. In some embodiments, the long carrier tube 180 of Figures 18A-18C may be used with the guide catheter 184 of Figures 17A-17D instead of the short carrier tube 182. Figures 18A-18C show an over-the-wire type device. In other embodiments, the long carrier tube 180 of Figures 18A-18C 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, 226, 336, or 436 is positioned next to the shaft 110, 210, 310, or the first shaft 410 and the second shaft 412, and is positioned inside the guide catheter 184.

[0131] 19A-19D show a portion of a drug eluting device including 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. In FIGS. 19A-19D, the drug eluting device is drug eluting device 200. In other embodiments, the drug eluting device of FIGS. 19A-19D may be drug eluting device 100, 300, or 400. Guide catheter 184 may be connected to inserter 186 by a luer lock connector or other suitable connection configuration.

[0132] The introducer 186 may be connected to the valve 188 by a luer lock connector or other suitable connection configuration. The introducer 186 may be passed over the guidewire 226. Using the introducer 186 to deliver the balloon 230 to the guide catheter 184 may facilitate pushing the balloon 230 within the guide catheter 184 because, without the introducer 186, the balloon 230 may buckle when pushed or may introduce air into the guide catheter 184 when the balloon 230 is pushed.

[0133] 19C-19D, valve 188 is a three-way valve configured to connect to the inserter 186, connect to the flushing device 189, and receive a portion of the drug-eluting device 200, such as shaft 210. In other embodiments, valve 188 may be a two-way valve configured to connect to the inserter 186 and receive a portion of the drug-eluting device 200, such as shaft 210. Valve 188 may be passed over a guidewire 226.

[0134] The flushing device 189 may be used to flush the introducer 186 and / or the guide catheter 184 to deflate the introducer 186 and allow the balloon 230 to be easily and safely transferred into the guide catheter 184 without any air.

[0135] 19A-19D, the guide catheter 184, the inserter 186, and the valve 188 are shown along with a portion of the drug-eluting device 200. In FIG. 19A, the shaft 210 is withdrawn through the inserter 186. In FIG. 19B, the shaft 210 is withdrawn through the inserter 186 and the balloon 230 is within the inserter 186. In FIG. 19C, the shaft 210 is withdrawn and passes through the valve 188. In FIG. 19C, 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 not be connected to the guide catheter 184 or to the valve 188. The inserter 186 may be connected to the guide catheter 184 by a luer lock connector or other suitable connection configuration. The inserter 186 may be connected to the valve 188 by a luer lock connector or other suitable connection configuration. In FIG.

[0136] In other embodiments, the guide catheter 184, the inserter 186, the valve 188, and / or the flushing device 189 of Figures 19A-19D may be used with the drug eluting devices 100, 300, or 400. In other embodiments, the inserter 186, the valve 188, and / or the flushing device 189 of Figures 19A-19D 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.

[0137] Methods for delivering drugs using drug-eluting devices

[0138] An exemplary first method for delivering a drug into a blood vessel includes providing a drug-eluting device 100. The first method also includes inserting a distal portion 110d of the shaft 110 into a blood vessel. The first method also includes supplying a drug to the balloon 130 through the drug lumen 114 and inflating the balloon 130 to deliver the drug into the blood vessel through a plurality of holes 132 in the balloon 130. The first method also includes compressing the balloon 130 by pulling the pull wire 128 using the actuator 108, thereby changing the balloon 130 from a longitudinally expanded state 134a to a longitudinally compressed state 134b and expelling at least a portion of the drug remaining within the balloon 130. The first method also includes returning the balloon 130 to the longitudinally expanded state 134a by the elastically deformable wire 150.

[0139] The first method includes providing a drug eluting device 100. The drug eluting device 100 includes a handle 106 having a drug port 104 configured to receive a drug. The drug eluting device 100 further includes a shaft 110 connected to the handle 106. The shaft 110 has a drug lumen 114 configured to receive a drug from the drug port 104 and a guidewire tube 116 configured to receive a guidewire 126 and to allow the guidewire 126 to extend out of a distal portion 110d of the shaft 110. The drug eluting device 100 further includes a balloon 130 attached to the distal portion 110d of the shaft 110 and configured to receive a drug from the drug lumen 114, the balloon 130 having a plurality of holes 132 that allow the drug to exit the balloon 130. The drug eluting device 100 further includes an anchor 140 connected to a distal portion of the balloon 130. The drug-eluting device 100 further includes an elastically deformable wire 150 having a distal end 150d connected to the distal portion 130d of the balloon 130 and a proximal end 150p connected to the guidewire tube 116. The drug-eluting device 100 further includes a pull wire 128 connected to the anchor 140. The handle 106 further includes an actuator 108 that is user actuatable to change the balloon 130 from a longitudinally expanded state 134a to a longitudinally compressed state 134b by pulling the pull wire 128. After pulling the pull wire 128 to compress the balloon 130, the elastically deformable wire 150 returns the balloon 130 to the longitudinally expanded state 134a. In some embodiments, the drug-eluting device 100 may further include a stop cock 102 connected to the drug port 104. In some embodiments, the shaft 110 may further include a pullwire lumen 118, with the pullwire 128 located within the pullwire lumen 118 of the shaft 110. 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 that includes similar components as described herein.

[0140] The first method includes inserting the distal portion 110d of the shaft 110 into a blood vessel such that the distal portion 110d of the shaft 110 is at a location within the blood vessel that is targeted for drug elution. Inserting the distal portion 110d of the shaft 110 into the blood vessel may include using a needle, trocar, or guide catheter 184 of Figures 17A-17D, an inserter 186 of Figures 19A-19D, a valve 188 of Figures 19A-19D, and / or an irrigation device 189 of Figures 19A-19D. The drug eluting device 100 may be used with a short carrier tube 182 of Figures 17A-17D or a long carrier tube 180 of Figures 18A-18C.

[0141] The first method includes the steps of supplying a drug to the balloon 130 through the drug lumen 114, inflating the balloon 130, and delivering the drug into the blood vessel through the multiple holes 132 of the balloon 130. When the balloon 130 is inflated, the balloon 130 is in a longitudinally expanded state 134a, as shown in FIG. 1A. The pressure of the balloon 130 in the longitudinally expanded state 134a is maintained by the drug contained within the balloon 130.

[0142] The first method includes using actuator 108 to compress balloon 130 by pulling pull wire 128, thereby changing balloon 130 from a longitudinally expanded state 134a of Figure 1A to a longitudinally compressed state 134b of Figure 1B and expelling at least a portion of the drug remaining within balloon 130. Pull wire 128 pulls anchor 140 to longitudinally compress balloon 130.

[0143] The first method includes allowing the elastically deformable wire 150 to return the balloon 130 to the longitudinally expanded state 134a, as in Figure 1C. When the actuator 108 is deactivated, the pull wire 128 stops pulling on the pull wire 128 and the balloon 130 is allowed to regain its length in returning to the longitudinally expanded state 134a. The elastically deformable wire 150 is allowed to expand to support the longitudinally expanded state 134a of the balloon 130.

[0144] A second exemplary method for delivering a drug into a blood vessel includes providing a drug-eluting device 200 using a long carrier tube 180 as the carrier tube 260. The second method also includes inserting the distal portion 210d of the shaft 210 and the distal portion 260d of the carrier tube 260 into the blood vessel. The second method also includes pushing the shaft 210 or pulling the carrier tube 260 so that the distal portion 210d of the shaft 210 and the balloon 230 are outside the carrier tube 260. The second method also includes supplying a drug to the balloon 230 via the drug lumen 214 to inflate the balloon 230 and deliver the drug into the blood vessel via the multiple holes 232 of the balloon 230. The second method also includes compressing the balloon 230 by pulling the shaft 210 using the actuator 208, thereby drawing the balloon 230 into the carrier tube 260, changing the balloon 230 from a radially expanded state 234a to a radially compressed state 234b, and expelling at least a portion of the drug remaining within the balloon 230.

[0145] The second method includes providing a drug eluting device 200. The drug eluting device 200 includes a handle 206 having a drug port 204 configured to receive a drug. The drug eluting device 200 further includes a shaft 210 connected to the handle 206. The shaft 210 has a drug lumen 214 configured to receive a drug from the drug port 204 and a guidewire tube 216 configured to receive a guidewire 226 and to allow the guidewire 226 to extend out of a distal portion 210d of the shaft 210. The drug eluting device 200 further includes a carrier tube 260 connected to the handle 206, the carrier tube 260 surrounding the shaft 210. The length of the carrier tube 260 is equal to or greater than the length of the shaft 210. The drug eluting device 200 further includes a balloon 230 attached to the distal portion 210d of the shaft 210 and configured to receive a drug from the drug lumen 214, the balloon 230 including a plurality of holes 232 configured to allow the drug to exit the balloon 230. The handle 206 includes an actuator 208 that is user actuatable to pull the shaft 210, thereby drawing the balloon 230 into the carrier tube 260 and changing the balloon 230 from a radially expanded state 234a to a radially compressed state 234b. In some embodiments, the drug eluting device 200 may further include a stop cock 202 connected to the drug port 204. In some embodiments, the drug eluting device 200 extends from a proximal portion 230p of the balloon 230 to a distal portion 230d of the balloon 230 and is aligned with the longitudinal axis A of the shaft 210 when in a relaxed state. L 2. In some embodiments, the drug eluting device 200 may further include one or more elastically deformable wires 256 that are curved radially outward relative to the distal end portion 210d of the carrier tube 260. In some embodiments, the drug eluting device 200 may further include a ring 270 connected to the distal end portion 210d of the carrier tube 260. The elastic modulus of the material of the ring 270 is greater than the elastic modulus of the material of the carrier tube 260. Although the second method is described with respect to the drug eluting device 200, it should be understood that the operation of the second method is equally applicable to other devices that include similar components as described herein.

[0146] The second method includes inserting the distal portion 210d of the shaft 210 and the distal portion 260d of the carrier tube 260 into a blood vessel such that the distal portion 210d of the shaft 210 is at a location within the blood vessel targeted for drug elution. In some embodiments, during insertion, the distal portion 210d of the shaft 210 may be positioned proximal to the distal portion 260d of the carrier tube 260, as shown in FIG. 8A. In other embodiments, during insertion, the distal portion 260d of the carrier tube 260 may be positioned distal to the distal portion 210d of the shaft 210, as shown in FIG. 8B.

[0147] The step of inserting the tip portion 210d of the shaft 210 into the blood vessel may include using a needle, trocar, or guide catheter 184 as in Figures 17A-17D, an inserter 186 as in Figures 19A-19D, a valve 188 as in Figures 19A-19D, and / or an irrigation device 189 as in Figures 19A-19D.

[0148] The second method includes pushing the shaft 210 or pulling the carrier tube 260 so that the distal portion 210d of the shaft 210 and the balloon 230 are outside the carrier tube 260. When the distal portion 210d of the shaft 210 is proximal to the distal portion 260d of the carrier tube 260, the shaft 210 is pushed forward or the carrier tube 260 is pulled so that the distal portion 210d of the shaft 210 is distal to the distal portion 260d of the carrier tube 260.

[0149] The second method includes supplying a drug to the balloon 230 through the drug lumen 214 to inflate the balloon 230 and deliver the drug into the blood vessel through the multiple holes 232 of the balloon 230. When the balloon 230 is inflated, the balloon 230 assumes a radially expanded state 234a, as shown in FIG 8C. The pressure that causes the balloon 230 to assume the radially expanded state 234a is maintained by the drug contained within the balloon 230.

[0150] The second method involves using actuator 208 to pull shaft 210 to compress balloon 230, thereby changing balloon 230 from radially expanded state 234a of Figure 8C to radially compressed state 234b of Figure 8D, and expelling at least a portion of the drug remaining in balloon 230. Pulling shaft 210 radially while retracting balloon 230 into carrier tube 260 radially compresses balloon 230 into radially compressed state 234b.

[0151] In some embodiments, the drug eluting device 200 includes one or more elastically deformable wires 256. When the actuator 208 is used to pull the shaft 210 to draw the balloon 230 into the carrier tube 260, the elastically deformable wires 256 cause the balloon 230 to be further compressed as compared to an embodiment in which the elastically deformable wires 256 are not present. In some embodiments, the drug eluting device 200 includes a ring 270. When the actuator 208 is used to pull the shaft 210 to draw the balloon 230 into the carrier tube 260, the balloon 230 is drawn into the ring 270, causing further compression of the balloon 230 as compared to an embodiment in which the ring 270 is not present. In some embodiments, the drug eluting device 200 includes one or more elastically deformable wires 256 and a ring 270. When the actuator 208 is used to pull the shaft 210 to draw the balloon 230 into the carrier tube 260, the balloon 230 is further compressed by the one or more elastically deformable wires 256 and the drawing of the balloon 230 into the ring 270, as compared to embodiments in which only one or more elastically deformable wires 256 or only the ring 270 are present.

[0152] In some embodiments, the second method includes inserting the guide catheter 184 into the blood vessel before inserting the distal portion 210d of the shaft 210 and the distal portion 260d of the carrier tube 260 into the blood vessel. The carrier tube 260 is connected to the guide catheter 284. In the step of inserting the distal portion 210d of the shaft 210 and the distal portion 260d of the carrier tube 260 into the blood vessel, the distal portion 210d of the shaft 210 is inserted into the guide catheter 284. In the step of pushing the shaft 210 or pulling the carrier tube 260, the shaft 210 is pushed such that the distal portion 210d of the shaft 210 and the balloon 230 are outside the guide catheter 184. In the step of compressing the balloon 230, the balloon 230 is retracted into the guide catheter 184, and as the balloon 230 is retracted into the guide catheter 184, the balloon 230 is radially compressed into the radially compressed state 234b.

[0153] A third exemplary method for delivering an agent into a blood vessel includes providing a drug-eluting device 200 using a short carrier tube 182 as the carrier tube 260. The third method also includes inserting a distal portion 210d of the shaft 210, a distal portion 260d of the carrier tube 260, and a guide catheter 184 into the blood vessel. The third method also includes pushing the shaft 210 such that the distal portion 210d of the shaft 210 and the balloon 230 are outside the carrier tube 260 and the guide catheter 184. The third method also includes supplying an agent to the balloon 230 via the agent lumen 214 and inflating the balloon 230 to deliver the agent into the blood vessel via the multiple holes 232 of the balloon 230. The third method also includes compressing the balloon 230 by pulling the shaft 210 using the actuator 208, thereby drawing the balloon 230 into the carrier tube 260, changing the balloon 230 from a radially expanded state 234a to a radially compressed state 234b, and expelling at least a portion of the drug remaining within the balloon 230.

[0154] The third method includes providing a drug-eluting device 200. The drug-eluting device 200 includes a handle 206 having a drug port 204 configured to receive a drug. The drug-eluting device 200 further includes a shaft 210 connected to the handle 206. The shaft 210 has a drug lumen 214 configured to receive a drug from the drug port 204 and a guidewire tube 216 configured to receive a guidewire 226 and to allow the guidewire 226 to extend out of a distal portion 210d of the shaft 210. The drug-eluting device 200 further includes a carrier tube 260 connected to or connectable to the handle 206, the carrier tube 260 surrounding the shaft 210. The length of the carrier tube 260 is less than the length of the shaft 210. The drug-eluting device 200 further includes a balloon 230 attached to the distal portion 210d of the shaft 210 and configured to receive the drug from the drug lumen 214, the balloon 230 including a plurality of holes 232 configured to allow the drug to exit the balloon 230. The handle 206 includes an actuator 208 that is user-actuable to pull the shaft 210 to draw the balloon 230 into the carrier tube 260 and change the balloon 230 from a radially expanded state 234a to a radially compressed state 234b. In some embodiments, the drug-eluting device 200 may further include a stop cock 202 connected to the drug port 204. In some embodiments, the drug-eluting device 200 extends from a proximal portion 230p of the balloon 230 to a distal portion 230d of the balloon 230 and is aligned with the longitudinal axis A of the shaft 210 when in a relaxed state. L 2. In some embodiments, the drug eluting device 200 may further include one or more elastically deformable wires 256 that are curved radially outward relative to the distal end portion 210d of the carrier tube 260. In some embodiments, the drug eluting device 200 may further include a ring 270 connected to the distal end portion 210d of the carrier tube 260. The elastic modulus of the material of the ring 270 is greater than the elastic modulus of the material of the carrier tube 260. Although the third method is described with respect to the drug eluting device 200, it should be understood that the operation of the third method is equally applicable to other devices that include similar components as described herein.

[0155] The third method includes inserting the distal portion 210d of the shaft 210, the distal portion 260d of the carrier tube 260, and the guide catheter 184 into a blood vessel such that the distal portion 210d of the shaft 210 is at a targeted location for drug elution within the blood vessel. In some embodiments, during insertion, the distal portion 210d of the shaft 210 can be positioned within a short carrier tube 182 as shown in FIG. 17A. In other embodiments, during insertion, the distal portion 260d of the carrier tube 260 can be positioned within a guide catheter 184 as shown in FIG. 17B.

[0156] The step of inserting the tip portion 210d of the shaft 210 into the blood vessel may include using a needle, trocar, or inserter 186 as in Figures 19A-19D, a valve 188 as in Figures 19A-19D, and / or a cleaning device 189 as in Figures 19A-19D.

[0157] The third method includes pushing the shaft 210 so that the tip portion 210d of the shaft 210 and the balloon 230 are outside the carrier tube 260 and the guide catheter 184. When the tip portion 210d of the shaft 210 is positioned within the short carrier tube 182, the shaft 210 is pushed forward so that the tip portion 210d of the shaft 210 is within the guide catheter 184. When the tip portion 210d of the shaft 210 is positioned within the guide catheter 184, the shaft 210 is pushed forward so that the tip portion 210d of the shaft 210 is outside the guide catheter 184.

[0158] The third method includes the steps of supplying a drug to the balloon 230 through the drug lumen 214 and inflating the balloon 230 to deliver the drug into the blood vessel through the multiple holes 232 of the balloon 230. When the balloon 230 is inflated, the balloon 230 is in a radially expanded state 234a, as shown in Figure 8C. The pressure that causes the balloon 230 to be in the radially expanded state 234a is maintained by the drug contained within the balloon 230.

[0159] A third method includes compressing the balloon 230 by pulling the shaft 210 using the actuator 208, thereby changing the balloon 230 from the radially expanded state 234a of Figure 8C to the radially compressed state 234b of Figure 8D, and expelling at least a portion of the agent remaining within the balloon 230. Pulling the shaft 210 radially as the balloon 230 is retracted into the guide catheter 184 radially compresses the balloon 230 into the radially compressed state 234b.

[0160] In some embodiments, the drug eluting device 200 includes one or more elastically deformable wires 256. When the actuator 208 is used to pull the shaft 210 to draw the balloon 230 into the carrier tube 260, the elastically deformable wires 256 cause the balloon 230 to be further compressed as compared to an embodiment in which the elastically deformable wires 256 are not present. In some embodiments, the drug eluting device 200 includes a ring 270. When the actuator 208 is used to pull the shaft 210 to draw the balloon 230 into the carrier tube 260, the balloon 230 is drawn into the ring 270, causing further compression of the balloon 230 as compared to an embodiment in which the ring 270 is not present. In some embodiments, the drug eluting device 200 includes one or more elastically deformable wires 256 and a ring 270. When the actuator 208 is used to pull the shaft 210 to draw the balloon 230 into the carrier tube 260, the balloon 230 is further compressed by drawing the one or more elastically deformable wires 256 and the balloon 230 into the ring 270, as compared to embodiments in which only one or more elastically deformable wires 256 or only the ring 270 are present.

[0161] An exemplary fourth method for delivering a drug into a blood vessel includes providing a drug-eluting device 300. The fourth method also includes inserting a distal portion 310d of the shaft 310 into a blood vessel. The fourth method also includes supplying a drug to the balloon 330 through the drug lumen 334 and inflating the balloon 330 to deliver the drug into the blood vessel through the multiple holes 332 of the balloon 330. The fourth method also includes compressing the balloon 330 by pulling the pull wire 328 using the actuator 308, thereby changing the balloon 330 from a longitudinally expanded state 334a to a longitudinally compressed state 334b, the longitudinally compressed state 334b ​​of the balloon 330 being an inverted state 334c, and expelling at least a portion of the drug remaining within the balloon 330.

[0162] The fourth method includes providing a drug eluting device 300. The drug eluting device 300 includes a handle 306 having a drug port 304 configured to receive a drug. The drug eluting device 300 further includes a shaft 310 connected to the handle 306. The shaft 310 includes a drug lumen 314 configured to receive a drug from the drug port 304 and a guidewire tube 316 configured to receive a guidewire 326 and to allow the guidewire 326 to extend out of a distal portion 310d of the shaft 310. The drug eluting device 300 further includes a balloon 330 attached to the distal portion 310d of the shaft 310 and configured to receive a drug from the drug lumen 314, the balloon 330 including a plurality of holes 332 configured to allow the drug to exit the balloon 330. The drug eluting device 300 further includes an anchor 340 connected to the distal portion 330d of the balloon 330. The drug eluting device 300 further includes a pullwire 328 connected to the anchor 340. The handle 306 includes an actuator 308 that is user actuatable to change the balloon 330 from a longitudinally expanded state 334a to a longitudinally compressed state 334b ​​by pulling on the pull wire 328. The longitudinally compressed state 334b ​​of the balloon is an inverted state 334c. In some embodiments, the drug-eluting device 300 may further include a stop cock 302 connected to the drug port 304. In some embodiments, the shaft 310 may further include a pull wire lumen 318, with the pull wire 328 located within the pull wire lumen 318 of the shaft 310. Although the fourth method is described with respect to the drug-eluting device 300, it should be understood that the operation of the fourth method is equally applicable to other devices that include similar components as described herein.

[0163] The fourth method includes inserting the distal end portion 310d of the shaft 310 into a blood vessel such that the distal end portion 310d of the shaft 310 is at a location targeted for drug elution within the blood vessel. Inserting the distal end portion 310d of the shaft 310 into the blood vessel may include using a needle, trocar, or guide catheter 184 as shown in Figures 17A-17D, an inserter 186 as shown in Figures 19A-19D, a valve 188 as shown in Figures 19A-19D, and / or a flushing device 189 as shown in Figures 19A-19D. The drug eluting device 300 may be used with the short carrier tube 182 of Figures 17A-17D or the long carrier tube 180 of Figures 18A-18C.

[0164] The fourth method includes the steps of supplying a drug to the balloon 330 via the drug lumen 314, inflating the balloon 330, and delivering the drug into the blood vessel via the multiple holes 332 of the balloon 330. When the balloon 330 is inflated, the balloon 330 is in a longitudinally expanded state 134a, as shown in Figures 13A-13B. The pressure that causes the balloon 330 to be in the longitudinally expanded state 334a is maintained by the drug contained within the balloon 330.

[0165] A fourth method includes compressing the balloon 330 by pulling the pull wire 328 using the actuator 308, thereby changing the balloon 330 from the longitudinally expanded state 334a of Figures 13A-13B to a longitudinally compressed state 334b ​​(which is an inverted state 334c of Figure 13C) and expelling at least a portion of the drug remaining within the balloon 330. The pull wire 328 pulls on the anchor 340 to invert and compress the balloon 330. Inversion of the balloon 330 causes the balloon 330 to be compressed.

[0166] A fifth exemplary method for delivering a drug into a blood vessel includes providing a drug-eluting device 400. The fifth method also includes inserting a distal portion 410d of a first shaft 410 and a distal portion 412d of a second shaft 412 into a blood vessel. The fifth method also includes supplying a drug to a balloon 430 through a drug lumen 414 and inflating the balloon 430 to deliver the drug into the blood vessel through a plurality of holes 432 of the balloon 430. The fifth method also includes compressing the balloon 430 by rotating the second shaft 412 relative to the first shaft 410 using the actuator 408, thereby changing the balloon 430 from a radially expanded state 434a to a radially compressed state 434b and expelling at least a portion of the drug remaining within the balloon 430.

[0167] The fifth method includes providing a drug eluting device 400. The drug eluting device 400 includes a handle 406 having a drug port 404 configured to receive a drug. The drug eluting device 400 further includes a first shaft 410 connected to the handle 406, the first shaft 410 including a drug lumen 414 further configured to receive a drug from the drug port 404. The drug eluting device 400 further includes a second shaft 412 connected to the handle 406, the second shaft 412 extending through the first shaft 410 and configured to move independently of the first shaft 410. The second shaft 412 is configured to receive a guidewire 426 and to allow the guidewire 426 to extend out of a distal portion 412d of the second shaft 412. The drug-eluting device 400 further includes a balloon 430 including a proximal portion 430p connected to a distal portion 410d of the first shaft 410 and a distal portion 430d connected to a distal portion 412d of the second shaft 412. The balloon 430 is configured to receive the drug from the drug lumen 414, and the balloon 430 has a plurality of holes 432 configured to allow the drug to exit the balloon 430. The actuator 408 can be actuated by a user to rotate the second shaft 412 relative to the first shaft 410, thereby changing the balloon 430 from a radially expanded state 434a to a radially compressed state 434b. In some embodiments, the drug-eluting device 400 may further include a stop cock 402 connected to the drug port 404. Although the fifth method is described with respect to the drug-eluting device 400, it should be understood that the operation of the fifth method is equally applicable to other devices including similar components as described herein.

[0168] The fifth method includes a step of inserting the distal end portion 410d of the first shaft 410 and the distal end portion 412d of the second shaft 412 into a blood vessel such that the distal end portion 410d of the first shaft 410 and the distal end portion 412d of the second shaft 412 are at a position targeted for drug elution within the vessel.

[0169] Inserting the distal portion 410d of the first shaft 410 and the distal portion 412d of the second shaft 412 into the blood vessel may include using a needle, trocar, or guide catheter 184 as in Figures 17A-17D, an inserter 186 as in Figures 19A-19D, a valve 188 as in Figures 19A-19D, and / or a flushing device 189 as in Figures 19A-19D. The drug-eluting device 400 may be used with the short carrier tube 182 of Figures 17A-17D or the long carrier tube 180 of Figures 18A-18C.

[0170] The fifth method includes the steps of supplying a drug to the balloon 430 through the drug lumen 414, inflating the balloon 430, and delivering the drug into the blood vessel through the multiple holes 432 in the balloon 430. When the balloon 430 is inflated, the balloon 430 is in a radially expanded state 434a, as shown in FIG. 15A. The pressure that causes the balloon 430 to be in the radially expanded state 434a is maintained by the drug entering the balloon 430.

[0171] A fifth method includes using the actuator 408 to rotate the second shaft 412 relative to the first shaft 410 to compress the balloon 430, thereby changing the balloon 430 from the radially expanded state 434a of Figure 15A to the radially compressed state 434b of Figure 15B and expelling at least a portion of the agent remaining within the balloon 430. The second shaft 412 can be rotated in a clockwise or counterclockwise direction.

[0172] Configuration of an Exemplary Embodiment 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 terminology is not intended to imply that such embodiments are necessarily exceptional or best examples).

[0173] As used herein, the term "coupled" or the like means that two members are directly or indirectly joined to one another. Such joining may be fixed (e.g., permanent) or movable (e.g., removable or releasable). Such joining may be accomplished as a single, integral body in which the two members or the two members and an additional intermediate member are integrally formed with one another, or in which the two members or the two members and an additional intermediate member are attached to one another.

[0174] It is important to note that the construction and arrangement of the various exemplary embodiments are illustrative only. 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 (e.g., changes in size, dimensions, construction, shape and proportions of various elements, parameter values, mounting arrangements, use of materials, colors, orientations, etc.) are possible without substantially departing from the novel teachings and advantages of the subject matter described herein. 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 those 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.

[0175] Although this specification contains many specific implementation details, these should not be construed as limiting the scope of the invention or what may be claimed, but rather as descriptions of features specific to particular embodiments of a particular invention. Certain features described in this specification in the context of separate embodiments may also be implemented in combination in a single embodiment. Conversely, various features described in the context of a single embodiment may also be implemented in multiple embodiments separately or in any suitable subcombination. Furthermore, even if features are described above as functioning in a particular combination and originally claimed as such, one or more features of a claimed combination may be deleted from the combination, and the claimed combination may be directed to a subcombination or variations of the subcombination.

[0176] As used herein, terms such as "substantially," "generally," "approximately," and the like 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 be able to describe certain features as 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 insignificant or inconsequential changes or modifications of the subject matter as described and claimed are considered to be within the scope of the appended claims.

[0177] Also, the term "or" is used in its inclusive (not exclusive) sense in the context of a list of elements, such that when used to connect a list of elements, the term "or" means one, some, or all of the elements in the list. Conjunctions such as the phrase "at least one of X, Y, and Z" are generally understood in the context in which they are used to convey that an item, term, etc. may be any of 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), unless otherwise indicated. Thus, such conjunctions are not intended to generally imply that a particular embodiment requires that at least one X, at least one Y, and at least one Z, respectively, be present, unless otherwise indicated.

[0178] Additionally, use of a range of values ​​herein (e.g., W1-W2, etc.) includes the maximum and minimum values ​​(e.g., W1-W2 includes W1, which includes W2, etc.) unless otherwise indicated. Additionally, use of a range of values ​​(e.g., W1-W2, etc.) does not necessarily require inclusion of intermediate values ​​within the range of values ​​(e.g., W1-W2 includes only W1 and W2, etc.) unless otherwise indicated.

Claims

1. A drug eluting device, comprising: a handle including a medication port configured to receive a medication; A shaft connected to the handle, a medication lumen configured to receive the medication from the medication port; and a shaft including a guidewire tube configured to receive a guidewire and allow the guidewire to extend out of a distal portion of the shaft; a balloon attached to the distal portion of the shaft and configured to receive the agent from the agent lumen, the balloon including a plurality of holes configured to allow the agent to exit the balloon; An anchor connected to a distal end portion of the balloon; a resiliently deformable wire having a distal end connected to the distal portion of the balloon and a proximal end connected to the guidewire tube; a pull wire connected to the anchor, the handle includes an actuator actuable by a user to pull the pull wire to change the balloon from a longitudinally expanded state to a longitudinally compressed state; pulling the pull wire to compress the balloon in the longitudinal direction and then causing the balloon to return to the longitudinally expanded state by the elastically deformable wire; Drug elution device.

2. The drug eluting device of claim 1 , wherein the distal end of the elastically deformable wire is attached to the distal portion of the balloon via the anchor.

3. The drug eluting device of claim 1 , wherein the elastically deformable wire is helical in shape.

4. The drug eluting device of claim 1 , wherein the elastically deformable wire has a straight shape.

5. The drug eluting device of claim 1 , wherein the elastically deformable wire is made of Nitinol or stainless steel.

6. 10. The drug eluting device of claim 1, wherein the spring constant of the elastically deformable wire varies along the length of the elastically deformable wire.

7. The drug eluting device of claim 1 , wherein said drug lumen and said guidewire tube are separate from one another.

8. The drug eluting device of claim 1 , wherein the guidewire tube extends through the drug lumen.

9. 10. The drug eluting device of claim 1, further comprising a stop cock connected to said drug port.

10. The drug eluting device of claim 1 , wherein the shaft further comprises a pullwire lumen, the pullwire being positioned within the pullwire lumen of the shaft.

11. A drug eluting device, comprising: a handle including a medication port configured to receive a medication; A shaft connected to the handle, a medication lumen configured to receive the medication from the medication port; and a shaft including a guidewire tube configured to receive a guidewire and allow the guidewire to extend out of a distal portion of the shaft; a carrier tube connected to or connectable to the handle, the carrier tube surrounding the shaft; a balloon attached to a distal portion of the shaft and configured to receive the agent from the agent lumen, the balloon including a plurality of holes configured to allow the agent to exit the balloon; the handle includes an actuator actuable by a user to pull the shaft to draw the balloon into the carrier tube and change the balloon from a radially expanded state to a radially compressed state. Drug elution device.

12. 12. The drug eluting device of claim 11, further comprising a stop cock connected to said drug port.

13. 12. The drug eluting device of claim 11, further comprising one or more resiliently deformable wires extending from a proximal portion of the balloon to a distal portion of the balloon and curving radially outward relative to a longitudinal axis of the shaft when in a relaxed state.

14. The drug eluting device of claim 13 , wherein the one or more elastically deformable wires are made of Nitinol or stainless steel.

15. 12. The drug eluting device of claim 11, further comprising a ring connected to a distal portion of said carrier tube, said ring having a modulus of elasticity greater than the modulus of elasticity of a material of said carrier tube.

16. The drug eluting device of claim 15, wherein the ring is made of a radiopaque material.

17. The drug eluting device of claim 11 , wherein the carrier tube is configured to be attached to a guide catheter.

18. A drug eluting device, comprising: a handle including a medication port configured to receive a medication; A shaft connected to the handle, a medication lumen configured to receive the medication from the medication port; and a shaft including a guidewire tube configured to receive a guidewire and allow the guidewire to extend out of a distal portion of the shaft; a balloon attached to the distal portion of the shaft and configured to receive the agent from the agent lumen, the balloon including a plurality of holes configured to allow the agent to exit the balloon; An anchor connected to a distal end portion of the balloon; a pull wire connected to the anchor, the handle includes an actuator actuable by a user to change the balloon from a longitudinally expanded state to a longitudinally compressed state by pulling the pull wire, the longitudinally compressed state of the balloon being an inverted state. Drug elution device.

19. 20. The drug eluting device of claim 18, wherein said drug lumen and said guidewire tube are separate from one another.

20. The drug eluting device of claim 18 , wherein the guidewire tube extends through the drug lumen.

21. 20. The drug eluting device of claim 18, further comprising a stop cock connected to said drug port.

22. 20. The drug eluting device of claim 18, wherein the shaft further comprises a pullwire lumen, the pullwire being located within the pullwire lumen of the shaft.

23. A drug eluting device, comprising: a handle including a medication port configured to receive a medication; a first shaft connected to the handle, the first shaft including an agent lumen configured to receive the agent from the agent port; a second shaft connected to the handle, the second shaft configured for independent movement through the first shaft and configured to receive the guidewire so that the guidewire can extend out of a distal portion of the second shaft; a balloon including a proximal portion connected to a distal portion of the first shaft and a distal portion connected to a distal portion of the second shaft; the balloon is configured to receive the agent from the agent lumen, the balloon including a plurality of holes configured to allow the agent to exit the balloon; the handle includes an actuator actuable by a user to rotate the second shaft relative to the first shaft, thereby changing the balloon from a radially expanded state to a radially compressed state. Drug elution device.

24. 24. The drug eluting device of claim 23, further comprising a stop cock connected to said drug port.

25. 1. A method of delivering a drug into a blood 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 shaft connected to the handle, a medication lumen configured to receive the medication from the medication port; and a shaft including a guidewire tube 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 the agent from the agent lumen, the balloon including a plurality of holes configured to allow the agent to exit the balloon; An anchor connected to a tip portion of the balloon; a resiliently deformable wire having a distal end connected to the distal portion of the balloon and a proximal end connected to the guidewire tube; a pull wire connected to the anchor, the handle includes an actuator actuable by a user to pull the pull wire to change the balloon from a longitudinally expanded state to a longitudinally compressed state; pulling the pull wire to compress the balloon in the longitudinal direction, and then causing the balloon to return to the longitudinally expanded state by the elastically deformable wire; inserting the distal portion of the shaft into a blood vessel; supplying the drug to the balloon through the drug lumen to inflate the balloon and deliver the drug into the blood vessel through the plurality of holes in the balloon; compressing the balloon by pulling the pull wire using the actuator, thereby changing the balloon from the longitudinally expanded state to the longitudinally compressed state and expelling at least a portion of the agent remaining within the balloon; and allowing the elastically deformable wire to return the balloon to the longitudinally expanded state. method.

26. 26. The method of claim 25, wherein the distal end of the elastically deformable wire is attached to the distal portion of the balloon via the anchor.

27. The method of claim 25 , wherein the elastically deformable wire is helical in shape.

28. The method of claim 25 , wherein the elastically deformable wire has a straight shape.

29. 26. The method of claim 25, wherein the elastically deformable wire is made of Nitinol or stainless steel.

30. 26. The method of claim 25, wherein the spring constant of the elastically deformable wire varies along the length of the elastically deformable wire.

31. 26. The method of claim 25, wherein the medication lumen and the guidewire tube are separate from one another.

32. The method of claim 25 , wherein the guidewire tube extends through the medication lumen.

33. 26. The method of claim 25, wherein the drug eluting device further comprises a stop cock connected to the drug port.

34. 26. The method of claim 25, wherein the shaft further comprises a pullwire lumen, the pullwire being positioned within the pullwire lumen of the shaft.

35. 1. A method of delivering a drug into a blood 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 shaft connected to the handle, a medication lumen configured to receive the medication from the medication port; and a shaft including a guidewire tube configured to receive a guidewire and allow the guidewire to extend out of a distal portion of the shaft; a carrier tube connected to the handle, the carrier tube surrounding the shaft, the length of the carrier tube being equal to or greater than the length of the shaft; a balloon attached to a distal portion of the shaft and configured to receive the agent from the agent lumen, the balloon including a plurality of holes configured to allow the agent to exit the balloon; the handle including an actuator actuable by a user to pull the shaft to draw the balloon into the carrier tube and change the balloon from a radially expanded state to a radially compressed state; inserting the distal portion of the shaft and the distal portion of the carrier tube into a blood vessel; pushing the shaft or pulling the carrier tube so that the tip portion of the shaft and the balloon are outside the carrier tube; supplying the drug to the balloon through the drug lumen to inflate the balloon and deliver the drug into the blood vessel through the plurality of holes in the balloon; and compressing the balloon by pulling on the shaft using the actuator, thereby drawing the balloon into the carrier tube, changing the balloon from a radially expanded state to a radially compressed state, and expelling at least a portion of the agent remaining within the balloon. method.

36. inserting a guide catheter into the blood vessel prior to inserting the distal portion of the shaft and the distal portion of the carrier tube into the blood vessel; In the step of inserting the distal end portion of the shaft and the distal end portion of the carrier tube into the blood vessel, the step of inserting the distal end portion of the shaft into the guide catheter; pushing the shaft or pulling the carrier tube, pushing the shaft so that the tip portion of the shaft and the balloon are outside the guide catheter; 36. The method of claim 35, further comprising the step of: retracting the balloon into the guide catheter in the step of compressing the balloon.

37. 36. The method of claim 35, wherein the drug eluting device further comprises a stopcock connected to the drug port.

38. 36. The method of claim 35, wherein the drug eluting device further comprises one or more elastically deformable wires extending from a proximal portion of the balloon to a distal portion of the balloon and curving radially outward relative to the longitudinal axis of the shaft in a relaxed state.

39. 40. The method of claim 38, wherein the one or more elastically deformable wires are made of Nitinol or stainless steel.

40. 40. The method of claim 39, wherein compressing the balloon is further accomplished by retracting the one or more elastically deformable wires into the carrier tube.

41. 36. The method of claim 35, wherein the drug eluting device further comprises a ring connected to the distal portion of the carrier tube, the elastic modulus of the material of the ring being greater than the elastic modulus of the material of the carrier tube.

42. 42. The method of claim 41, wherein the ring is made of a radiopaque material.

43. 42. The method of claim 41, wherein the step of compressing the balloon is further accomplished by drawing the balloon into the ring.

44. 1. A method of delivering a drug into a blood 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 shaft connected to the handle, a medication lumen configured to receive the medication from the medication port; and a shaft including a guidewire tube configured to receive a guidewire and allow the guidewire to extend out of a distal portion of the shaft; a carrier tube connected to or connectable to the handle, the carrier tube surrounding the shaft, the length of the carrier tube being less than the length of the shaft, the carrier tube being configured to be attached to a guide catheter; and a balloon attached to a distal portion of the shaft and configured to receive the agent from the agent lumen, the balloon including a plurality of holes configured to allow the agent to exit the balloon; the handle including an actuator actuable by a user to pull the shaft to draw the balloon into the carrier tube and change the balloon from a radially expanded state to a radially compressed state; inserting the distal portion of the shaft, the distal portion of the carrier tube, and the guide catheter into a blood vessel; pushing the shaft so that the tip portion of the shaft and the balloon are outside of the carrier tube and the guide catheter; supplying the drug to the balloon through the drug lumen to inflate the balloon and deliver the drug into the blood vessel through the plurality of holes in the balloon; and compressing the balloon by pulling on the shaft using the actuator, thereby drawing the balloon into the guide catheter, changing the balloon from a radially expanded state to a radially compressed state, and expelling at least a portion of the agent remaining within the balloon. method.

45. 45. The method of claim 44, wherein the drug eluting device further comprises a stop cock connected to the drug port.

46. 45. The method of claim 44, wherein the drug eluting device further comprises one or more elastically deformable wires extending from a proximal portion of the balloon to a distal portion of the balloon and curving radially outward relative to the longitudinal axis of the shaft when in a relaxed state.

47. 47. The method of claim 46, wherein the one or more elastically deformable wires are made of Nitinol or stainless steel.

48. 48. The method of claim 47, wherein compressing the balloon is further accomplished by retracting the one or more elastically deformable wires into the carrier tube.

49. 45. The method of claim 44, wherein the drug eluting device further comprises a ring connected to the distal portion of the carrier tube, the elastic modulus of the material of the ring being greater than the elastic modulus of the material of the carrier tube.

50. 50. The method of claim 49, wherein the ring is made of a radiopaque material.

51. 51. The method of claim 50, wherein the step of compressing the balloon is further accomplished by drawing the balloon into the ring.

52. 1. A method of delivering a drug into a blood 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 shaft connected to the handle, a medication lumen configured to receive the medication from the medication port; and a shaft including a guidewire tube configured to receive a guidewire and allow the guidewire to extend out of a distal portion of the shaft; a balloon attached to the distal portion of the shaft and configured to receive the agent from the agent lumen, the balloon including a plurality of holes configured to allow the agent to exit the balloon; An anchor connected to a tip portion of the balloon; a pull wire connected to the anchor, the handle includes an actuator actuable by a user to change the balloon from a longitudinally expanded state to a longitudinally compressed state by pulling the pull wire, the longitudinally compressed state of the balloon being an inverted state; and inserting the distal portion of the shaft into a blood vessel; supplying the drug to the balloon through the drug lumen to inflate the balloon and deliver the drug into the blood vessel through the plurality of holes in the balloon; compressing the balloon by pulling the pull wire using the actuator, thereby changing the balloon from the longitudinally expanded state to the longitudinally compressed state, the longitudinally compressed state of the balloon being an inverted state, and expelling at least a portion of the agent remaining within the balloon. method.

53. 53. The method of claim 52, wherein the medication lumen and the guidewire tube are separate from one another.

54. 53. The method of claim 52, wherein the guidewire tube extends through the medication lumen.

55. 53. The method of claim 52, wherein the drug eluting device further comprises a stopcock connected to the drug port.

56. 53. The method of claim 52, wherein the shaft further comprises a pullwire lumen, the pullwire being positioned within the pullwire lumen of the shaft.

57. 1. A method of delivering a drug into a blood 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 first shaft connected to the handle, the first shaft including an agent lumen configured to receive the agent from the agent port; a second shaft connected to the handle, the second shaft configured for independent movement through the first shaft and configured to receive a guidewire such that the guidewire can extend out of a distal portion of the second shaft; a balloon including a proximal portion connected to a distal portion of the first shaft and a distal portion connected to a distal portion of the second shaft, the balloon configured to receive the agent from the agent lumen and including a plurality of holes configured to allow the agent to exit the balloon; the handle including an actuator actuable by a user to rotate the second shaft relative to the first shaft, thereby changing the balloon from a radially expanded state to a radially compressed state; inserting the distal end portion of the first shaft and the distal end portion of the second shaft into a blood vessel; supplying the drug to the balloon through the drug lumen to inflate the balloon and deliver the drug into the blood vessel through the plurality of holes in the balloon; and compressing the balloon by rotating the second shaft relative to the first shaft using the actuator, thereby changing the balloon from the radially expanded state to the radially compressed state and expelling at least a portion of the agent remaining within the balloon. method.

58. 58. The method of claim 57, wherein the drug eluting device further comprises a stopcock connected to the drug port.

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