Drug elution 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 to a drug elution device for delivering drugs, such as drugs containing antiproliferative agents, into blood vessels. More specifically, this application relates to a drug elution device that compresses a drug delivery balloon to deliver an additional portion of the drug into the blood vessel and reduce the amount of drug remaining in the balloon.

[0002] Vascular diseases can cause narrowing and restenosis of blood vessels. Plaque buildup on the vessel walls narrows the vessels, and if the vessels are not reopened through treatment such as angioplasty, it is detrimental to health. During angioplasty, a dilator such as a balloon is inserted into the blood vessel, advanced to the narrowed area, and then dilated radially outward relative to the vessel wall to widen the vessel. Such devices can also be used to deliver drugs into the blood vessels, for example, via the balloon. [Overview of the Initiative]

[0003] With known drug elution devices, a large portion of the drug remains inside the balloon after inflation, resulting in waste.

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

[0005] In some embodiments, the drug elution device includes a handle containing a drug port configured to receive a drug. The drug elution 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, allowing the guidewire to extend outward from the tip of the shaft. The drug elution device also includes a balloon attached to the tip of the shaft and configured to receive a drug from the drug lumen, the balloon containing a plurality of holes configured to allow the drug to exit the balloon. The drug elution device also includes an anchor connected to the tip of the balloon. The drug elution device also includes an elastically deformable wire having a tip connected to the tip of the balloon and a base connected to the guidewire tube. The drug elution device also includes a pull wire connected to the anchor. The handle includes an actuator that can be operated by the user to change the balloon from a longitudinally expanded state to a longitudinally compressed state by pulling the pull wire. After the balloon is compressed by pulling the pull wire, the elastically deformable wire returns the balloon to a longitudinally expanded state.

[0006] In some embodiments, the drug elution device includes a handle containing a drug port configured to receive a drug. The drug elution device also includes a shaft connected to the handle, containing 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 outward from the tip of the shaft. The drug elution device also includes a carrier tube connected to or connectable to the handle, the carrier tube surrounding the shaft. The drug elution device also includes a balloon attached to the tip of the shaft, configured to receive a drug from the drug lumen, the balloon containing a plurality of holes configured so that the drug can exit the balloon. The handle includes an actuator that can be operated by the user to pull the shaft, thereby retracting 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 elution device includes a handle containing a drug port configured to receive a drug. The drug elution 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 so that the guidewire can extend outward from the tip of the shaft. The drug elution device also includes a balloon attached to the tip of the shaft and configured to receive a drug from the drug lumen, the balloon containing a plurality of holes configured so that the drug can exit the balloon. The drug elution device also includes an anchor connected to the tip of the balloon. The drug elution device also includes a pull wire connected to the anchor. The handle includes an actuator that can be operated by the 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.

[0008] In some embodiments, the drug elution device includes a handle containing a drug port configured to receive a drug. The drug elution device also includes a first shaft connected to the handle, the first shaft containing a drug lumen configured to receive a drug from the drug port. The drug elution device also includes a second shaft connected to the handle, the second shaft configured to move independently through the first shaft, and the second shaft containing a guide wire, which is configured to extend outward from the tip portion of the second shaft. The drug elution device also includes a balloon containing a base portion connected to the tip portion of the first shaft and a tip portion connected to the tip portion of the second shaft. The balloon is configured to receive a drug from the drug lumen, and the balloon contains a plurality of holes configured to allow the drug to exit the balloon. An actuator is user-operable 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 for delivering a drug into a blood vessel includes the step of providing a drug elution device, the drug elution device including a handle with a drug port configured to receive a drug. The drug elution 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 so that the guidewire can extend outward from the tip of the shaft. The drug elution device also includes a balloon attached to the tip of the shaft and configured to receive a drug from the drug lumen, the balloon including a plurality of holes configured so that the drug can exit the balloon. The drug elution device also includes an anchor connected to the tip of the balloon. The drug elution device also includes an elastically deformable wire having a tip connected to the tip of the balloon and a proximal end connected to the guidewire tube. The drug elution device also includes a pull wire connected to the anchor. The handle includes an actuator that can be operated by the user to change the balloon from a longitudinally expanded state to a longitudinally compressed state by pulling the pull wire. After the balloon is compressed by pulling the pull wire, the balloon is returned to its longitudinally expanded state by an elastically deformable wire. This method also includes the step of inserting the tip of the shaft into the blood vessel. This method also includes the step of supplying the drug to the balloon through the drug lumen to inflate the balloon and delivering the drug into the blood vessel through multiple holes in the balloon. This method also includes the step of changing the balloon from a longitudinally expanded state to a longitudinally compressed state by using an actuator to pull the pull wire and compress the balloon, thereby releasing at least some of the drug remaining in the balloon. This method also includes the step of returning the balloon to a longitudinally expanded state by an elastically deformable wire.

[0010] In some embodiments, a method for delivering a drug into a blood vessel includes the step of providing a drug elution device, which includes a handle with a drug port configured to receive the drug. The drug elution device also includes a shaft connected to the handle, which includes a drug lumen configured to receive the drug from the drug port and a guidewire tube configured to receive a guidewire so that the guidewire can extend outward from the tip of the shaft. The drug elution device also includes a carrier tube connected to the handle, which surrounds the shaft. The length of the carrier tube is greater than or equal to the length of the shaft. The drug elution device also includes a balloon attached to the tip of the shaft and configured to receive the drug from the drug lumen, which includes a plurality of holes configured so that the drug can exit the balloon. The handle includes an actuator that can be operated by the user to pull the shaft, thereby retracting the balloon into the carrier tube and changing the balloon from a radially expanded state to a radially compressed state. The method also includes the step of inserting the tip of the shaft and the tip of the carrier tube into a blood vessel. This method also includes the step of pushing the shaft or pulling the carrier tube so that the tip of the shaft and the balloon are outside the carrier tube. This method also includes the step of supplying the drug to the balloon through the drug lumen to inflate the balloon and deliver the drug into the blood vessel through the multiple holes in the balloon. This method also includes the step of 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 releasing at least some of the drug remaining in the balloon.

[0011] In some embodiments, a method for delivering a drug into a blood vessel includes the step of providing a drug elution device, which includes a handle with a drug port configured to receive the drug. The drug elution device also includes a shaft connected to the handle, which includes a drug lumen configured to receive the drug from the drug port and a guidewire tube configured to receive a guidewire and allow the guidewire to extend outward from the tip of the shaft. The drug elution device also includes a carrier tube connected to or connectable to the handle, which surrounds the shaft. The length of the carrier tube is shorter than the length of the shaft. The drug elution device also includes a balloon attached to the tip of the shaft and configured to receive the drug from the drug lumen, which includes a plurality of holes configured to allow the drug to exit the balloon. The handle includes an actuator that can be operated by the user to pull the shaft, thereby retracting the balloon into the carrier tube and changing the balloon from a radially expanded state to a radially compressed state. The method also includes the step of inserting the tip of the shaft and the tip of the carrier tube into a blood vessel. This method also includes the step of pushing the shaft so that the tip of the shaft and the balloon are outside the carrier tube and guide catheter. This method also includes the step of supplying the drug to the balloon through the drug lumen to inflate the balloon and deliver the drug into the blood vessel through the multiple holes in the balloon. This method also includes the step of compressing the balloon by pulling the shaft using an 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 some of the drug remaining in the balloon.

[0012] In some embodiments, a method for delivering a drug into a blood vessel includes the step of providing a drug elution device, which includes a handle with a drug port configured to receive the drug. The drug elution device also includes a shaft connected to the handle. The shaft includes a drug lumen configured to receive the drug from the drug port and a guidewire tube configured to receive a guidewire so that the guidewire can extend outward from the tip of the shaft. The drug elution device also includes a balloon attached to the tip of the shaft and configured to receive the drug from the drug lumen, the balloon including a plurality of holes configured so that the drug can exit the balloon. The drug elution device also includes an anchor connected to the tip of the balloon. The drug elution device also includes a pull wire connected to the anchor. The handle includes an actuator that can be operated by the 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 the step of inserting the tip of the shaft into a blood vessel. This method also includes the step of supplying the drug to the balloon via a drug lumen to inflate the balloon and delivering the drug into the blood vessel through multiple holes in the balloon. This method also includes the step of changing the balloon from a longitudinally expanded state to a longitudinally compressed state by compressing the balloon by pulling a pull wire using an actuator, thereby releasing at least some of the drug remaining in the balloon. The longitudinally compressed state of the balloon is an inverted state.

[0013] In some embodiments, a method for delivering a drug into a blood vessel includes the step of providing a drug elution device, the drug elution device including a handle with a drug port configured to receive the drug. The drug elution device also includes a first shaft connected to the handle, the first shaft including a drug lumen configured to receive the drug from the drug port. The drug elution device also includes a second shaft connected to the handle, the second shaft configured to move independently through the first shaft, and the second shaft receiving a guidewire so that the guidewire can extend outward from the tip portion of the second shaft. The drug elution device also includes a balloon including a proximal portion connected to the tip portion of the first shaft and an distal portion connected to the tip portion of the second shaft. The balloon is configured to receive the drug from the drug lumen, and the balloon includes a plurality of holes configured so that the drug can exit the balloon. An actuator is user-operable 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 the step of inserting the tip of a first shaft and the tip of a second shaft into a blood vessel. The method also includes the step of supplying a drug to a balloon through a drug lumen to inflate the balloon and delivering the drug into a blood vessel through multiple holes in the balloon. The method also includes the step of compressing the balloon by rotating the second shaft relative to the first shaft using an actuator, thereby changing the balloon from a radially expanded state to a radially compressed state and releasing at least some of the drug remaining in the balloon. [Brief explanation of the drawing]

[0014] The above and other features of this disclosure will become more fully apparent from the following description and the attached claims in conjunction with the attached drawings. The attached drawings are used to further describe this disclosure in detail, with the understanding that these drawings illustrate only some embodiments of this disclosure and therefore do not limit its scope. [Figure 1A] This is a left side view of the drug elution device in the first configuration according to the first embodiment, with the balloon expanded and extended in the longitudinal direction. [Figure 1B] This is a left side view of the drug elution device in the second configuration according to the first embodiment, in which the balloon is compressed longitudinally by an anchor. [Figure 1C] This is a left side view of the drug elution device in the third configuration according to the first embodiment, after the balloon has returned to its longitudinally expanded state. [Figure 2A] These are front, top, and left-side perspective views of a handle that may be included in the drug dissolution device of the first embodiment. [Figure 2B] Figure 2A shows front, top, and left side perspective views of the handle in another configuration where the actuator is adjusted to move the pull wire. [Figure 2C] Figure 2A shows perspective views of the hub included in the handle, including the front, bottom, and left side views, and indicates the stop cock. [Figure 3] This is a left side view of a part of the drug elution device according to the first embodiment. [Figure 4A] This is a cross-sectional view of a portion of the drug elution device according to the first embodiment, taken along plane AA in Figure 3. [Figure 4B] This is a cross-sectional view of a portion of the drug elution device according to the first embodiment, cut along plane BB in Figure 3. [Figure 4C] This is a cross-sectional view of a portion of the drug elution device according to the first embodiment, taken along plane CC in Figure 3. [Figure 5A] This is a cross-sectional view of a portion of the drug elution device according to the first embodiment, taken along plane AA in Figure 3. [Figure 5B] This is a cross-sectional view of a portion of the drug elution device according to the first embodiment, cut along plane BB in Figure 3. [Figure 5C] This is a cross-sectional view of a portion of the drug elution device according to the first embodiment, taken along plane CC in Figure 3. [Figure 6A]A perspective view of the tip portion of the drug eluting device according to the first embodiment, with the balloon expanded and in a longitudinally expanded state, showing the front, top, and left side views. [Figure 6B] A perspective view of the cross-section of the tip portion of the drug eluting device according to the first embodiment, taken along the plane A-A of FIG. 6A, with the balloon expanded and in a longitudinally expanded state, showing the front, top, and left side views. [Figure 6C] A perspective view of the cross-section of the tip portion of the drug eluting device according to the first embodiment, taken along the plane A-A of FIG. 6A, with the balloon expanded and in a longitudinally expanded state, showing the front, top, and left side views. [Figure 7A] A front cross-sectional view of the tip portion of the drug eluting device according to the first embodiment, taken along the plane A-A of FIG. 6B, where the anchor is not connected to the balloon and the guide wire tube. [Figure 7B] A front cross-sectional view of the tip portion of the drug eluting device according to the first embodiment, taken along the plane A-A of FIG. 6C, where the anchor is not connected to the balloon and the guide wire tube. [Figure 7C] A front cross-sectional view of the tip portion of the drug eluting device according to the first embodiment, taken along the plane A-A of FIG. 6B or FIG. 6C, where the anchor is connected to the balloon and the guide wire tube. [Figure 8A] A left side view of the drug eluting device in the first configuration according to the second embodiment, where the shaft is inside the carrier tube. [Figure 8B] A left side view of the drug eluting device in the second configuration according to the second embodiment, where the tip of the shaft is positioned at the tip side of the carrier tube. [Figure 8C] A left side view of the drug eluting device in the third configuration according to the second embodiment, with the balloon expanded and in a radially expanded state. [Figure 8D] A left side view of the drug eluting device in the fourth configuration according to the second embodiment, with the balloon retracted into the carrier tube and in a radially compressed state. [Figure 9A]These are front, top, and left-side perspective views of a handle that may be included in the drug elution device of the second embodiment. [Figure 9B] Figure 9A shows perspective views of the hub included in the handle, including the front, bottom, and left side views, and indicates the stop cock. [Figure 10A] This is a right side view of a portion of the drug elution device in the first configuration according to the second embodiment, where the balloon has been expanded to a radially expanded state. [Figure 10B] This is a right side view of a portion of a drug elution device in a second configuration according to a second embodiment, in which the balloon is compressed radially relative to the carrier tube and partially retracted into the carrier tube. [Figure 10C] This is a right side view of a portion of the drug elution device in a third configuration according to a second embodiment, where the balloon is radially compressed relative to the carrier tube and further fully retracted into the carrier tube. [Figure 11A] This is a left side view of the drug elution device in the first configuration, which is a modified version of the second embodiment, in which the balloon is expanded to a radially expanded state. [Figure 11B] This is a left side view of a drug elution device in a second configuration, a modification of the second embodiment, in which the balloon is drawn in while radially compressed within the carrier tube. [Figure 12] These are front, top, and left-side perspective views of the tip portion of a drug elution device according to a modification of the second embodiment, in which the balloon is expanded radially. [Figure 13A] This is a left side view of a drug elution device according to the third embodiment. [Figure 13B] This is a left side view of a part of the drug elution device in the first configuration according to the third embodiment, with the balloon expanded and extended in the longitudinal direction. [Figure 13C] This is a left side view of a portion of the drug elution device in the second configuration according to the third embodiment, where the balloon is compressed longitudinally and inverted. [Figure 14A]These are front, top, and left-side perspective views of the tip portion of the drug elution device of the third embodiment, with the balloon expanded and extended in the longitudinal direction. [Figure 14B] This is a left-side cross-sectional view of the tip portion of the drug elution device of the third embodiment, taken along plane AA in Figure 14A, with the balloon expanded and extended in the longitudinal direction. [Figure 15A] This is a left side view of a portion of the drug elution device in the first configuration according to the fourth embodiment, where the balloon has been expanded to a radially expanded state. [Figure 15B] This is a left side view of a portion of the drug elution device in the second configuration according to the fourth embodiment, in which the balloon is compressed radially. [Figure 16] This is a left side cross-sectional view of a handle that may be included in the drug elution device of the fourth embodiment. [Figure 17A] This is a right-side view of the drug elution device used with a short carrier tube and guide catheter in the first configuration. [Figure 17B] This is a right-side view of the drug elution device used with a short carrier tube and guide catheter in the second configuration. [Figure 17C] This is a right-side view of the drug elution device used with a short carrier tube and guide catheter in the third configuration. [Figure 17D] This is a right-side view of the drug elution device used with the short carrier tube and guide catheter in the fourth configuration. [Figure 18A] This is a right-side view of the drug elution device used with a long carrier tube in the first configuration. [Figure 18B] This is a right-side view of the drug elution device used with a long carrier tube in the second configuration. [Figure 18C] This is a right-side view of the drug elution device used with a long carrier tube in the third configuration. [Figure 19A] This is a right side view of the tip portion of the drug elution device used with the inserter, valve, guide catheter, and cleaning device in the first configuration. [Figure 19B] This is a right side view of the tip portion of the drug elution device used with the inserter, valve, guide catheter, and cleaning device in the second configuration. [Figure 19C] This is a right-side view of the tip portion of the drug elution device used with the inserter, valve, guide catheter, and cleaning device in the third configuration. [Figure 19D] This is a right-side view of the tip portion of the drug elution device used with the inserter, valve, guide catheter, and cleaning device in the fourth configuration. [Modes for carrying out the invention]

[0015] The following detailed description refers to the accompanying drawings, which constitute part of this specification. In the drawings, unless otherwise specified in the context, similar symbols typically indicate similar components. The exemplary embodiments described in the detailed description, drawings, and claims are not intended to be limiting. Other embodiments may be used and other modifications made without departing from the spirit or scope of the subject matter presented herein. It will be readily apparent that the aspects of this disclosure generally described herein and shown in the drawings can be arranged, substituted, combined, and designed in a wide variety of different configurations. All of these are expressly considered and constitute part of this disclosure.

[0016] To reduce the costs associated with drug elution devices, it may be desirable to reduce the amount of drug remaining in the balloon after it has been inflated in a blood vessel. However, it can be difficult to deliver the drug into the blood vessel without leaving any of it in the balloon. The drug remaining in the balloon may not be recovered and may not be used for another patient, thus resulting in waste.

[0017] Various embodiments of drug elution devices described herein may offer one or more advantages, including, for example, (1) reducing the costs associated with the operation of the drug elution device by enabling a reduction in the amount of drug inserted into the drug elution device, and (2) facilitating the ability of the user of the drug elution device to operate the drug elution device.

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

[0019] Various embodiments of drug elution devices described herein can be used in conjunction with a carrier tube. The carrier tube may surround the shaft and / or balloon of the drug elution device. The carrier tube can facilitate the entry of a portion of the drug elution device into a blood vessel. The use of the carrier tube applies an external force to the balloon, holding it in a radially compressed and deformed state. The carrier tube may be positioned at or near the target of drug elution.

[0020] In this specification, the term “proximal end” refers to the end of the drug elution device closest to the user, and the term “proximal end” refers to the end of the drug elution device closest to the subject (subject) to which the drug elution procedure is performed.

[0021] First Embodiment Figures 1A to 7C show a drug elution device 100 (e.g., a therapeutic device) for delivering a drug (e.g., a drug containing an antiproliferative agent such as sirolimus) into a blood vessel according to a first embodiment. The drug elution device 100 includes a handle 106 having a drug port 104 configured to receive the drug. The drug elution device 100 further includes a shaft 110 connected to the handle 106. The shaft 110 has a drug lumen 114 configured to receive the 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 the tip portion 110d of the shaft 110. The drug elution device 100 further includes a balloon 130 attached to the tip portion 110d of the shaft 110 and configured to receive the 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 elution device 100 further includes an anchor 140 connected to the tip of the balloon 130. The drug elution device 100 further includes an elastically deformable wire 150 having a tip 150d connected to the tip 130d of the balloon 130 and a base 150p connected to the guide wire tube 116. The drug elution device 100 further includes a pull wire 128 connected to the anchor 140. The handle 106 further includes an actuator 108, which is user-operable to change the balloon 130 from a longitudinally expanded state 134a to a longitudinally compressed state 134b by pulling the pull wire 128. After the balloon 130 is compressed by pulling the pull wire 128, the elastically deformable wire 150 returns the balloon 130 to the longitudinally expanded state 134a. In some embodiments, the drug elution 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 pull wire lumen 118, and the pull wire 128 is located within the pull wire lumen 118 of the shaft 110.

[0022] The drug elution device 100 includes a handle 106 (e.g., a grip, handgrip, etc.). The handle 106 is configured for the user to grasp, allowing the user to operate the drug elution device 100. The handle 106 may also be configured to be held with one hand, allowing the user to perform additional operations with the other hand.

[0023] In Figures 2A and 2B, the handle 106 includes a body 107 (e.g., shell, housing, container, etc.). The body 107 of the handle 106 holds the hub 101, stop cock 102, drug port 104, and actuator 108 together. The body 107 of the handle 106 allows the user to operate the drug elution device 100 by holding the handle 106.

[0024] The main body 107 may be made from polyethylene, polyolefin (e.g., polypropylene, polyamide), polyester (e.g., polyethylene terephthalate), fluoropolymer (e.g., polytetrafluoroethylene (PTFE)), ethylene / tetrafluoroethylene copolymer (ETFE), polyetheretherketone (PEEK), polyamide, elastomer, polyester elastomer, polycarbonate, polyetherimide, polystyrene, polyacetal, ABS (acrylonitrile, butadiene, styrene copolymer synthetic) resin, or other suitable material.

[0025] The handle 106 also includes a hub 101. In Figure 2A, the hub is located on the proximal end side of the handle 106. However, in other embodiments, the hub 101 may be located on the upper, lower, left, right, or proximal end side of the handle 106. The hub 101 includes a drug port 104 (e.g., a hole, opening, or constriction) configured to receive the drug. As shown in Figure 2C, the hub 101 may also include a stopcock 102 (e.g., a valve). The stopcock 102 allows the user of the drug elution device 100 to control the flow of the drug into the drug elution device 100. When the stopcock 102 is in the closed position, the drug lumen 114 is sealed, thereby preventing the drug from flowing beyond the stopcock 102 in the proximal or tip direction. Therefore, when the balloon 130 is compressed, the drug is forced out of the balloon 130 through the multiple holes 132 rather than flowing through the drug lumen 114 in the proximal direction. Since the stop cock 102 is located on the tip side of the drug port 104, when the stop cock 102 is open, the drug can be supplied to the drug port 104 and flow through the stop cock 102. In other embodiments, the stop cock 102 may be provided separately from the hub 101. For example, the hub 101 may be located on the base end side of the handle 106, and the stop cock 102 may be located on the tip side of the 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 can be operated by the user to operate the drug dissolution device 100. The actuator 108 is operated by the user of the drug dissolution device 100 along the longitudinal axis A of the handle 106. L It is operated by moving it in the proximal or tip direction in a direction parallel to the longitudinal axis A. In other embodiments, the actuator 108 is operated by the user of the drug elution device 100 along the longitudinal axis A LThe wheel may be operated by rotating it in a direction parallel to the direction. In Figure 2B, the actuator 108 is moved in the proximal direction compared to Figure 2A, as a result the pull wire 128 is pulled in the proximal direction, the anchor 140 is pulled, the balloon 130 is compressed in the longitudinal direction, and the drug is discharged from the multiple holes 132 of the balloon 130. In Figure 2A, the actuator 108 is located on the upper side of the handle 106. However, in other embodiments, the actuator 108 may be located at the bottom, left side, or right side of the handle 106.

[0027] The drug elution device 100 also includes a shaft 110 (e.g., a catheter, tube, pipe, cylinder, conduit, etc.). The shaft 110 is connected to the handle 106. The shaft 110 can be connected to the handle 106 by adhesive bonding, an interlocking mechanism, press-fitting, screw fasteners, or other suitable connection configurations. The shaft can be permanently fixed to the handle 106 so that the user cannot remove the shaft 110 from the handle 106.

[0028] The shaft 110 may be made of fluoropolymer (e.g., polytetrafluoroethylene (PTFE)), ethylene / tetrafluoroethylene copolymer (ETFE), polyetheretherketone (PEEK), polyurethane, polyamide elastomer, polyester elastomer, polyurethane elastomer, polyimide, polycarbonate, polyetherimide, fluororesin, or other suitable material.

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

[0030] The shaft 110 may have a cross-sectional shape that is circular, elliptical, polygonal, rounded polygonal, or other geometric shape. The shaft 110 may have a maximum cross-sectional width (for example, the diameter when the cross-sectional shape is circular) in the range of approximately 0.5 to 10 mm (including the boundary), and ideally 0.5 to 7 mm.

[0031] Figure 3 shows a portion of the drug elution device 100. The drug elution device 100 may be a rapid exchange type device, in which case the guide wire 126 enters the shaft 110 at a position on the shaft 110 closer to the tip of the shaft 110 than where the shaft 110 is connected to the handle 106. In other embodiments, the drug elution device 100 may be an over-the-wire type device, in which case the guide wire 126 enters the shaft 110 through the handle 106. The guide wire tube 116 configured to receive the guide wire 126 extends longitudinally through a portion of the length of the shaft 110.

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

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

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

[0035] As shown in Figure 3, the guidewire tube 116 is configured to receive the guidewire 126, which extends outward from the tip portion 110d of the shaft 110. The guidewire tube 116 extends longitudinally through a portion of the shaft 110. The cross-sectional shape of the guidewire tube 116 may be circular, elliptical, polygonal, rounded polygonal, or other geometric shape. The maximum cross-sectional width of the guidewire tube 116 (e.g., diameter if the cross-sectional shape is circular) is in the range of approximately 0.1 to 1 mm (including the boundary), and ideally may be 0.35 to 0.9 mm.

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

[0037] The drug elution device 100 also includes a balloon 130. The balloon 130 is attached to the tip portion 110d of the shaft 110. The balloon 130 may be attached to the tip portion 110d of the shaft 110 by being positioned on the tip portion 110d of the shaft 110 and joined by adhesive, welding, or other suitable connection configuration. The balloon 130 is configured to receive the 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 compressed longitudinally. The preset folds or creases of the balloon 130 may be configured so that the balloon 130 is regularly compressed longitudinally.

[0038] Balloon 130 may be made from polyamide, polyester, polyurethane, polyamide elastomer, polyester elastomer, polyurethane elastomer, or other suitable material.

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

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

[0041] The widths of the multiple holes 132 in the balloon 130 may each be in the range of approximately 100 nm to 10 μm, ideally 100 nm to 5 μm. In Figure 1A, the multiple holes 132 in the balloon 130 may have the same width. However, in other embodiments, the multiple holes 132 in the balloon 130 may have different widths.

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

[0043] In Figure 1A, the multiple holes 132 of the balloon 130 are positioned so that the spacing between the multiple holes 132 of the balloon 130 is uniform. However, in other embodiments, the multiple holes 132 of the balloon 130 may be positioned with different spacing between them.

[0044] The drug elution device 100 also includes an anchor 140 (e.g., a block, weight, cap, etc.). The anchor 140 is connected to the tip portion 130d of the balloon 130. The anchor 140 may be connected to the tip portion 130d of the balloon 130 by swaging, crimping, or other suitable connection configuration. In Figures 7A and 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 and the outer portion 140o of the anchor 140. The inner portion 140i of the anchor 140 may be positioned to surround the guide wire tube 116. The guidewire tube 116, the inner portion 140i of the anchor 140, the elastically deformable wire 150 or multiple elastically deformable wire portions 152, the balloon 130, and the outer portion 140o in Figure 7A or Figure 7B are connected by swaging, crimping, or other suitable connection configurations, and these components may be connected as in the configuration of Figure 7C. In Figure 7C, the elastically deformable wire 150 or multiple elastically deformable wire portions 152 are located between the inner portion 140i of the anchor 140 and the balloon 130, and these are swaged. In some embodiments, the balloon 130 may include a tip shaft to which the balloon 130 connects to the anchor 140, and the tip shaft reduces the likelihood that the tip portion of the drug elution device 100 will cause trauma to the blood vessel.

[0045] The anchor 140 may be made of plastic, nitinol, gold, platinum, stainless steel, tungsten, tantalum, or other suitable material. The width of the anchor 140 may be in the range of approximately 0.5 to 10 mm, for example, 1 to 4 mm. In Figure 6A, the anchor 140 has a cylindrical shape. However, in other embodiments, the shape of the anchor 140 may be cylindrical, elliptical, hemispherical, or other shapes.

[0046] The drug elution device 100 also includes an elastically deformable wire 150 (e.g., thread, strand, line, filament, etc.). The elastically deformable wire 150 has a tip 150d connected to an anchor 140, and as shown in Figures 7A to 7C, the anchor 140 is connected to the tip 130d of the balloon 130. The base end 150p of the elastically deformable wire 150 is connected to the guide wire tube 116 via a marker band 154 (e.g., hoop, band, disc, 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, it can be imaged using imaging modalities such as X-ray, fluoroscopy, or other suitable imaging modalities. The radiopaque material of the marker band 154 facilitates the imaging detection and tracking of the tip portion 110d of the shaft 110 when the tip portion 110d of the shaft 110 is in a blood vessel. Such detection and tracking of the marker band 154 can improve the operation and positioning of the drug elution device 100 in the blood vessel and improve the targeting of the location of a part of the blood vessel. This is because the user can obtain information about the location of the tip portion 110d of the shaft 110 by knowing the position of the marker band 154 by imaging.

[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 mm to 1 mm.

[0049] The elastically deformable wire 150 can be in a relaxed state with longitudinal expansion, or in a collapsed state with longitudinal contraction. The deformation state is a state in which an external force is applied to the elastically deformable wire 150. The relaxation state is a state in which no external force is applied to the elastically deformable wire 150. In the relaxation state, i.e., when the elastically deformable wire 150 is not compressed, the elastically deformable wire 150 is in a relaxed state with longitudinal expansion, and supports the longitudinally expanded shape of the balloon 130, which is in the longitudinally expanded state 134a. In Figure 6B, the balloon 130 is in the longitudinally expanded state 134a, and the elastically deformable wire 150 is in a relaxed state with longitudinal expansion. In the deformation state, i.e., when the elastically deformable wire 150 is compressed by the anchor 140 and its shape is restricted in a longitudinally contracted state, the elastically deformable wire 150 is in a longitudinally contracted deformation state.

[0050] The elastically deformable wire 150 may have a spring constant that varies along its length 150L. When the spring constant varies along the length 150L of the elastically deformable wire 150, and the elastically deformable wire 150 is compressed in the longitudinal direction, the portion of the elastically deformable wire 150 with a lower spring constant is compressed in the longitudinal direction before the portion of the elastically deformable wire 150 with a higher spring constant.

[0051] In some embodiments, the spring constant of the base end 150p of the elastically deformable wire 150 may be higher than the spring constant of the tip end 150d of the elastically deformable wire 150. When the spring constant of the base end 150p of the elastically deformable wire 150 is higher than the spring constant of the tip end 150d of the elastically deformable wire 150, and the wire is compressed longitudinally, the tip end 150d of the elastically deformable wire 150 is compressed longitudinally before the base end 150p of the elastically deformable wire 150 is compressed longitudinally. Compressing the tip end 150d of the elastically deformable wire 150 longitudinally before the base end 150p of the elastically deformable wire 150 makes it easier to prevent interference or blockage of the drug pathway through the balloon 130, which could reduce the flow of drug through the drug elution device 100. In another embodiment, the elastically deformable wire 150 may have a spring constant at its base end 150p that is lower than the spring constant at its tip end 150d. In yet another embodiment, the elastically deformable wire 150 may have different spring constants at multiple points along its length 150L.

[0052] The tip 150d of the elastically deformable wire 150 may be attached to the tip 130d of the balloon 130 via the anchor 140. The tip 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 located inside the balloon 130, as shown in Figures 6B and 6C. Before the balloon 130 expands to its 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 its 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, supporting the longitudinally expanded state 134a of the balloon 130.

[0054] In Figure 6B, the elastically deformable wire 150 has a helical shape 150h. In the helical shape 150h, the elastically deformable wire 150 has a shape composed of a series of rotations from the base end 150p to the tip end 150d of the elastically deformable wire 150. The rotations of the helical shape 150h may be circular, elliptical, or other rounded configurations.

[0055] In Figure 6C, the elastically deformable wire 150 has a linear shape 150s. In the linear 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 the base portion 130p of the balloon 130 to the tip portion 130d of the balloon 130, along the longitudinal axis A of the shaft 110. LIt is curved radially outward in direction RO relative to the direction. The width of the multiple elastically deformable wire portions 152 may be in the range of approximately 0.1 to 2 mm, for example, 0.5 to 1 mm. In Figure 6C, the multiple elastically deformable wire portions 152 are shown to each have substantially similar widths. However, in other embodiments, the multiple elastically deformable wire portions 152 may have different widths. In Figure 6C, the multiple elastically deformable wire portions 152 have six elastically deformable wire portions 152. In other embodiments, the multiple elastically deformable wire portions 152 may have one, two, three, four, five, six, seven, eight, nine, or more elastically deformable wire portions 152. When the elastically deformable wire 150 having a linear shape 150s is compressed in the longitudinal direction, the multiple elastically deformable wire portions 152 are aligned with the longitudinal axis A of the shaft 110. L It deforms radially outward in direction RO relative to the given direction.

[0056] The drug elution device 100 also includes pull wires 128 (e.g., thread, strand, line, filament, etc.). In Figure 2A, the drug elution device 100 includes two pull wires 128. In other embodiments, the drug elution 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 the anchor 140. By connecting the pull wire 128 to the anchor 140, when the pull wire 128 is pulled, the anchor 140 becomes movable towards the base end, compressing the balloon 130.

[0057] The pull wire 128 can be pulled by the actuator 108 when the user activates the actuator 108. By pulling the pull wire 128, the balloon 130 changes from a longitudinally expanded state 134a to a longitudinally compressed state 134b. In Figure 1A, the balloon 130 is in the longitudinally expanded state 134a. In Figure 1B, the balloon 130 is in the longitudinally compressed state 134b. When the balloon 130 changes from the longitudinally expanded state 134a to the longitudinally compressed state 134b, at least some of the drug that remained inside the balloon 130 but had not yet come out of the balloon 130 comes out through the multiple holes 132 of the balloon 130 and enters the blood vessels.

[0058] In Figures 1A and 1C, the pull wire 128 is pulled to compress the balloon 130 to a longitudinally compressed state 134b, and then the elastically deformable wire 150 returns the balloon 130 to a longitudinally expanded state 134a. In Figure 1A, while the balloon 130 is inflated to a longitudinally expanded state 134a by the chemical and / or after it has expanded, the elastically deformable wire 150 expands to support the longitudinally expanded state 134a of the balloon 130. After the actuator 108 is activated to pull the pull wire 128 and move the anchor 140 toward the base end, compressing the balloon 130 to a longitudinally compressed state 134b, in Figure 1B, the elastically deformable wire 150 is also compressed by the anchor 140, so the elastically deformable wire 150 is in a longitudinally contracted deformed state within the balloon 130. The actuator 108 then stops operating, allowing the pull wire 128 to stop pulling on the pull wire 128 and to recover its length as the balloon 130 returns to its longitudinally expanded state 134a, as shown in Figure 1C, so that the elastically deformable wire 150 can expand to support the longitudinally expanded state 134a of the balloon 130. In the 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 elution device 100 may be used with a long carrier tube 180 (discussed in further detail herein). In other embodiments, the drug elution device 100 may be used with a short carrier tube 182 (discussed in further detail herein). In some embodiments, the drug elution device 100 may be used with either the long carrier tube 180 or the short carrier tube 182, and the carrier tube is configured to be attached to a guide catheter 184 (discussed in further detail herein).

[0060] Second Embodiment Figures 8A to 12 show a drug elution device 200 (e.g., a therapeutic device) for intravascular delivery of a drug (e.g., a drug containing an antiproliferative agent such as sirolimus) according to a second embodiment. The drug elution device 200 includes a handle 206 having a drug port 204 configured to receive the drug. The drug elution device 200 further includes a shaft 210 connected to the handle 206. The shaft 210 includes a drug lumen 214 configured to receive the drug from the drug port 204 and a guidewire tube 216 configured to receive a guidewire 226, the guidewire 226 extending outward from the tip portion 210d of the shaft 210. The drug elution 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 elution device 200 further includes a balloon 230 attached to the tip 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 can be operated by the user to pull the shaft 210 to retract 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 elution device 200 may further include a stop cock 202 connected to the drug port 204. In some embodiments, the drug elution device 200 extends from the base portion 230p of the balloon 230 to the tip portion 230d of the balloon 230 and is aligned with the longitudinal axis A of the shaft 210 when relaxed. L The device may further include one or more elastically deformable wires 256 that are curved radially outward relative to the carrier tube 260. In some embodiments, the drug elution device 200 may further include a ring 270 connected to the tip portion 210d of the carrier tube 260. The elastic modulus of the material of the ring 270 is greater than that of the material of the carrier tube 260.

[0061] The drug elution device 200 includes a handle 206 (e.g., grip, handgrip, etc.). The handle 206 is configured in the same way as the handle 106. The handle 206 includes a body 207 (e.g., shell, housing, container, etc.) configured in the same way as the body 107. In Figure 9B, the handle 206 also includes a hub 201 configured in the same way as the hub 101. The hub 201 includes a drug port 204 (e.g., hole, opening, throttling, etc.) configured in the same way as the drug port 104. The handle 206 may also include a stop cock 202 (e.g., valve, etc.) configured in the same way as the 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 can be operated by a user to operate the drug elution device 200. The actuator 208 allows the user of the drug elution device 200 to move the actuator 208 clockwise or counterclockwise around the length of the handle 206 along the longitudinal axis A. L It is operated by rotating it in a direction parallel to the shaft. When the actuator 208 is operated, the shaft 210 is pulled towards the base end, the balloon 230 is drawn into the carrier tube 260, the balloon 230 is compressed radially, and the drug is discharged from the multiple holes 232 in the balloon 230. In Figure 9A, the actuator 208 is located on the top of the handle 206. However, in other embodiments, the actuator 208 may be located on the bottom, left side, or right side of the handle 206.

[0063] The drug elution device 200 also includes a shaft 210 (e.g., a catheter, tube, pipe, cylinder, conduit, etc.). The shaft 210 is connected to the handle 206. The shaft 210 may be connected to the handle 206 by adhesive bonding, an interlocking mechanism, press-fitting, screw fasteners, or other suitable connection configurations. The shaft 210 may be permanently fixed to the handle 206 so that the user cannot remove the shaft 210 from the handle 206.

[0064] The shaft 210 may be made of fluoropolymer (e.g., polytetrafluoroethylene (PTFE)), ethylene / tetrafluoroethylene copolymer (ETFE), polyetheretherketone (PEEK), polyurethane, polyamide elastomer, polyester elastomer, polyurethane elastomer, polyimide, polycarbonate, polyetherimide, fluororesin, or other suitable material.

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

[0066] The cross-sectional shape of the shaft 210 may be circular, elliptical, polygonal, rounded polygonal, or other geometric shape. The maximum cross-sectional width of the shaft 210 (for example, the diameter if the cross-sectional shape is circular) is in the range of approximately 0.5 to 10 mm (including the boundary), and ideally 0.5 to 7 mm.

[0067] Figures 10A to 10C show a partial right side view of the drug elution device 200. The drug elution device 200 may be a rapid-replacement type device, in which case the guide wire 226 enters the shaft 210 at a position on the shaft 210 closer to the tip of the shaft 210 than where the shaft 210 is connected to the handle 206. In other embodiments, the drug elution device 200 is an over-the-wire type device, in which case the guide wire 226 enters the shaft 210 through the handle 206. The guide wire tube 216 configured to receive the guide wire 226 extends longitudinally through a portion of the length of the shaft 210.

[0068] The shaft 210 includes a drug lumen 214 (e.g., a cavity, space, etc.) and a guidewire tube 216 (e.g., a pipe, cylinder, conduit, etc.). The drug lumen 214 is configured in the same way as the drug lumen 114. The guidewire tube 216 is configured in the same way as the guidewire tube 116.

[0069] The drug elution device 200 also includes a carrier tube 260 (e.g., a sheath, guide sheath, cover, etc.). In Figures 8A to 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 surrounds the shaft 210, and is configured 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, lock connector, fitting connector, or other appropriate connection configuration. The carrier tube 260 may be fixed to the handle 206 so that the user cannot remove the carrier tube 260 from the handle 206.

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

[0071] The carrier tube 260 may be made from fluoropolymers (e.g., polytetrafluoroethylene (PTFE)), ethylene / tetrafluoroethylene copolymers (ETFE), polyetheretherketone (PEEK), polyurethane, polyamide elastomer, polyester elastomer, polyurethane elastomer, polyimide, polycarbonate, polyetherimide, tungsten, stainless steel, Ni-Ti, or other suitable materials.

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

[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 (for example, the diameter when the cross-sectional shape is circular) is in the range of approximately 1 mm to 15 mm (including the boundary), for example, 2 mm to 8 mm. The wall thickness of the carrier tube 260 may be in the range of approximately 0.1 mm to 1 mm (including the boundary).

[0074] The drug elution device 200 also includes a balloon 230. The balloon 230 is configured in the same way as the balloon 130. However, when the drug enters the balloon 230 from the drug lumen 214, the balloon 230 expands to a radially expanded state 234a compared to the longitudinally expanded state 134a of the balloon 130. The balloon 230 includes multiple holes 232 (e.g., constrictions, openings, slits, etc.) configured in the same way as the multiple holes 132 of the balloon 130.

[0075] An actuator 208, which can be operated by the user to pull on the shaft 210, pulls 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. When the balloon 230 is pulled into the carrier tube 260, the balloon is radially compressed relative to the carrier tube 260. When the balloon 230 is radially compressed relative to the carrier tube 260, the balloon 230 is compressed, which allows for a smooth compression operation, and when the balloon 230 changes from a radially expanded state 234a to a radially compressed state 234b, at least some of the drug remaining inside the balloon 230 is discharged from the balloon 230 through the multiple holes 232.

[0076] The drug elution device 200 may further include one or more elastically deformable wires 256 (e.g., threads, strands, lines, filaments, etc.), the elastically deformable wires 256 extending from the proximal end portion 230p of the balloon 230 to the tip portion 230d of the balloon 230, and when one or more elastically deformable wires 256 are in a relaxed state, along the longitudinal axis A of the shaft 210.L It curves radially outward relative to the direction. A deformed state is a state in which an external force is applied to one or more elastically deformable wires 256, and a relaxed state is a state in which no external force is applied to one or more elastically deformable wires 256. When in a relaxed state, i.e., when one or more elastically deformable wires 256 are located outside the carrier tube 260, one or more elastically deformable wires 256 are in a radially expanded relaxed state to support the radially expanded state 234a of the balloon 230. When in a deformed state, i.e., when one or more elastically deformable wires 256 are located inside the carrier tube 260 and expansion is restricted by the carrier tube 260, one or more elastically deformable wires 256 are in a radially contracted deformed state. While the balloon 230 is expanding into the radially expanded state 234a and / or after expansion, one or more elastically deformable wires 256 change from a radially contracted deformed state to a radially expanded relaxed state. In Figures 11A and 11B, the drug elution device 200 includes three elastically deformable wires 256. In Figure 12, the drug elution device 200 includes six elastically deformable wires 256. In other embodiments, the drug elution device 200 may have one, two, three, four, five, six, or more elastically deformable wires 256.

[0077] One or more elastically deformable wires 256 may be made of nitinol or stainless steel. The width of one or more elastically deformable wires 256 may be in the range of about 0.1 to 2 mm (including the boundary), for example, 0.3 to 1 mm. In Figures 11A to 11B and Figure 12, the widths of one or more elastically deformable wires 256 are the same. However, in other embodiments, the widths of one or more elastically deformable wires 256 may be different.

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

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

[0080] The elastic modulus of the material of ring 270 is greater than that of the material of carrier tube 260. Because the elastic modulus of the material of ring 270 is greater than that of the material of carrier tube 260, when the balloon 230 is pulled into the carrier tube 260, ring 270 can provide stronger resistance to the balloon 230, and compared to when ring 270 is not present, ring 270 provides a greater amount of compression to the balloon 230, allowing for smoother compression 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. If the ring 270 is made of a radiopaque material, it can be imaged using imaging modalities such as X-ray, fluoroscopy, or other suitable imaging modalities. The radiopaque material of the ring 270 facilitates the imaging detection and tracking of the tip portion 260d of the carrier tube 260 when the tip portion 260d of the carrier tube 260 is in a blood vessel. Such detection and tracking of the ring 270 can improve the operation and positioning of the drug elution device 200 in the blood vessel and improve the targeting of the location of a part of the blood vessel. This is because the user can obtain information about the location of the tip portion 260d of the carrier tube 260 through imaging of the position of the ring 270.

[0082] In Figures 8A to 8D and 10A to 10C, in one embodiment, the drug elution device 200 includes a carrier tube 260 but does not include one or more elastically deformable wires 256 or rings 270. In Figure 8A, in one configuration, the shaft 210 and the carrier tube 260 may be inserted into a blood vessel such that the tip portion 210d of the shaft 210 is proximal to the tip portion 260d of the carrier tube 260. In Figure 8B, in another configuration, the shaft 210 and the carrier tube 260 may be inserted into a blood vessel such that the tip portion 210d of the shaft 210 is proximal to the tip portion 260d of the carrier tube 260. In the configuration shown in Figure 8A, when the tip portion 210d of the shaft 210 is on the proximal end side of the tip portion 260d of the carrier tube 260, the tip portion 210d of the shaft 210 may be moved in the tip direction so that the tip portion 210d of the shaft 210 is on the tip side of the tip portion 260d of the carrier tube 260, as shown in the configuration shown in Figure 8B. In Figures 8C and 10A, the balloon 230 can be inflated with the drug, and the balloon 230 will be in a radially expanded state 234a, and the drug will exit the balloon 230 through multiple holes 232 in the balloon 230. In Figures 8D and 10B-10C, the actuator 208 is activated to pull the shaft 210, drawing the base portion 230p of the balloon 230 into the carrier tube 260. By compressing the balloon 230 to a radially compressed state 234b, at least some of the drug remaining in the radially expanded state 234a of the balloon 230 is released from the balloon 230 through the multiple holes 232.

[0083] In other embodiments, the drug elution 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 the drug to a radially expanded state 234a, thereby allowing the drug to exit through several holes 232 in the balloon 230 and enter the bloodstream. When the actuator 208 is activated to pull the shaft 210 and compress the balloon 230 to a radially compressed state 234b, the balloon 230 is retracted into the carrier tube 260. When the balloon 230 is retracted into the carrier tube 260, it is radially compressed, thereby allowing at least some of the drug remaining inside the balloon 230 to exit through the several holes 232 in the balloon. When the actuator 208 is activated to pull the shaft 210 and compress the balloon 230 radially to a radially compressed state 234b, one or more elastically deformable wires 256 are compressed, and the balloon 230 is also radially compressed. Pulling one or more elastically deformable wires 256 as the balloon 230 is retracted into the carrier tube 260 applies further radial compression to the balloon 230 compared to embodiments without the elastically deformable wires 256, thereby causing at least some of the remaining drug inside the balloon 230 to be discharged through the multiple holes 232 of the balloon 230.

[0084] In other embodiments, the drug elution device 200 includes a carrier tube 260 and a ring 270, but does not include one or more elastically deformable wires 256. The balloon 230 is inflated with the drug to a radially expanded state 234a, thereby allowing the drug to exit through several holes 232 in the balloon 230 and enter the bloodstream. The actuator 208 is activated to pull the shaft 210, compressing the balloon 230 radially to a radially compressed state 234b, thereby drawing the balloon 230 into the carrier tube 260. When the balloon 230 is drawn into the carrier tube 260, it is compressed radially, thereby allowing at least some of the drug remaining inside the balloon 230 to be discharged through several holes 232 in the balloon. The actuator 208 is activated to pull the shaft 210, compressing the balloon 230 radially to a radially compressed state 234b, drawing the balloon 230 into the carrier tube 260 and ring 270. Retracting the balloon 230 into the carrier tube 260 and ring 270 imposes further radial compression on the balloon 230 compared to embodiments without the ring 270, thereby causing at least some of the remaining drug inside the balloon 230 to be discharged through the multiple holes 232 of the balloon 230.

[0085] In Figures 11A and 11B, in one embodiment, the drug elution device 200 includes a carrier tube 260, one or more elastically deformable wires 256, and a ring 270. In Figures 11A and 11B, the balloon 230 is inflated with the drug and becomes radially expanded 234a, thereby allowing the drug to exit through multiple holes 232 in the balloon 230 and enter the blood vessel. In Figure 11B, when the actuator 208 is activated to pull the shaft 210 and compress the balloon 230 radially into a radially compressed state 234b, the balloon 230 is retracted into the carrier tube 260 and ring 270. When the actuator 208 is activated to pull the shaft 210 and compress the balloon 230 radially into a radially compressed state 234b, one or more elastically deformable wires 256 are also compressed, and the balloon 230 is radially compressed. Pulling the balloon 230 into the carrier tube 260 and ring 270 while simultaneously pulling one or more elastically deformable wires 256 applies further radial compression to the balloon 230 compared to embodiments where only the ring 270 or only one or more elastically deformable wires 256 are present, thereby causing any remaining agent inside the balloon 230 to be discharged through the multiple holes 232 of the balloon 230.

[0086] Third Embodiment Figures 13A to 14B show a drug elution device 300 (e.g., a therapeutic device) for intravascular delivery of a drug (e.g., a drug containing an antiproliferative agent such as sirolimus) according to a third embodiment. The drug elution device 300 includes a handle 306 having a drug port 304 configured to receive the drug. The drug elution device 300 further includes a shaft 310 connected to the handle 306. The shaft 310 includes a drug lumen 314 configured to receive the drug from the drug port 304 and a guidewire tube 316 configured to receive a guidewire 326, the guidewire 326 extending outward from the tip portion 310d of the shaft 310. The drug elution device 300 further includes a balloon 330 attached to the tip portion 310d of the shaft 310 and configured to receive the 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 elution device 300 further includes an anchor 340 connected to the tip portion 330d of the balloon 330. The drug elution device 300 further includes a pull wire 328 connected to the anchor 340. The handle 306 includes an actuator 308 that can be operated by the user 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 elution device 300 may further include a stop cock 302 connected to a drug port 304. In some embodiments, the shaft 310 may further include a pull wire lumen 318, and the pull wire 328 is located within the pull wire lumen 318 of the shaft 310.

[0087] The drug elution device 300 includes a handle 306 (e.g., grip, handgrip, etc.). The handle 306 is configured in the same way as the handle 106 in Figures 2A and 2B. The handle 306 includes a body 307 (e.g., shell, housing, container, etc.) configured in the same way as the body 107. The handle 306 also includes a hub 301 configured in the same way as the hub 101 in Figure 2C. The hub 301 includes a drug port 304 (e.g., hole, opening, throttling, etc.) configured in the same way as the drug port 104. The handle 306 also includes an actuator 308 (e.g., tab, button, wheel, knob, etc.) configured in the same way as the actuator 108. The handle 306 also includes a stop cock 302 (e.g., valve, etc.) configured in the same way as the stop cock 102.

[0088] The drug elution device 300 also includes a shaft 310 (e.g., a catheter, tube, pipe, cylinder, conduit, etc.) configured in the same way as the shaft 110.

[0089] The drug elution device 300 may be a rapid-replacement type device configured in the same way as the drug elution device 100, as shown in Figure 3. In another embodiment, the drug elution device 300 may be an over-the-wire type device in which the guide wire 326 enters the shaft 310 through the handle 306.

[0090] The shaft 310 includes a drug lumen 314 (e.g., a cavity, space, etc.) configured in the same way as the drug lumen 114. In some embodiments, the shaft 310 also includes a pull wire lumen 318 (e.g., a cavity, space, etc.) configured in the same way as the pull wire lumen 118. The shaft 310 also includes a guide wire tube 316 (e.g., a pipe, cylinder, conduit, etc.) configured in the same way as the guide wire tube 116. The drug lumen 314, pull wire lumen 318, and guide wire tube 316 may be configured in the same way as the drug lumen 114, pull wire lumen 118, and guide wire tube 116 in Figures 4A-4C and Figures 5A-5C.

[0091] The drug elution device 300 also includes a balloon 330 configured in the same way as the balloon 130. The balloon 330 includes a plurality of holes 332 (e.g., constrictions, openings, slits, etc.) configured in the same way as the plurality of holes 132 of the balloon 130.

[0092] The drug elution device 300 also includes an anchor 340 (e.g., a block, weight, cap, etc.) configured in the same way as the anchor 140.

[0093] The drug elution device 300 also includes a pull wire 328 (e.g., thread, strand, line, filament, etc.) configured in the same way as the pull wire 128.

[0094] The pull wire 328 may be pulled by the actuator 308 when the user operates the actuator 308. By pulling the pull wire 328, the balloon 330 changes from a longitudinally expanded state 334a to a longitudinally compressed state 334b, which becomes the inverted state 334c. In the inverted state 334c, the tip portion 330d of the balloon 330 is pulled towards the base end, thereby changing the tip portion 330d of the balloon from a concave shape to a convex shape. In Figures 13B and 14A to 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 becomes the inverted state 334c. When the balloon 330 changes from a state 334a where it is expanded in the longitudinal direction to a state 334b ​​where it is compressed in the longitudinal direction, i.e., an inverted state 334c, at least some of the drug that remained inside the balloon 330 but had not yet come out of the balloon 330 comes out of the multiple holes 332 of the balloon 330 and enters the blood vessel.

[0095] In Figures 13A to 13C, the drug elution device 300 includes an anchor 340 connected to the tip portion 330d of the balloon 330, the anchor 340 being connected to a pull wire 328, and the compressed state 334b ​​of the balloon 330 in the longitudinal direction is the inverted state 334c. The balloon 330 can expand with the drug to the longitudinally expanded state 334a shown in Figure 13B. Next, the actuator 308 is activated to pull the pull wire 328, pulling the anchor 340 and compressing the balloon 330, thereby causing the balloon 330 to be compressed in the longitudinal direction 334b, that is, the inverted state 334c shown in Figure 13C. When the balloon 330 transitions from the longitudinally expanded state 334a in Figure 13B to the longitudinally compressed state 334b ​​and inverted state 334c in Figure 13C, the tip portion 330d of the balloon 330 is pulled towards the base via the anchor 340, thereby causing the tip portion 330d of the balloon 330 to move towards the base beyond another portion of the balloon 330. The balloon 330 may be made of a flexible material, so that when the tip portion 330d of the balloon 330 is pulled by the pull wire 328 via the anchor 340, the balloon 330 will be in the inverted state 334c in Figure 13C rather than the longitudinally compressed state 134b in Figure 1B. When the balloon 330 changes from the longitudinally expanded state 334a to the inverted state 334c, at least some of the remaining drug inside the balloon 330 is discharged from the balloon 330 through the multiple holes 332.

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

[0097] Fourth Embodiment Figures 15A to 16 show a drug elution device 400 (e.g., a therapeutic device) for intravascular delivery of a drug (e.g., a drug containing an antiproliferative agent such as sirolimus) according to a fourth embodiment. The drug elution device 400 includes a handle 406 having a drug port 404 configured to receive the drug. The drug elution 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 the drug from the drug port 404. The drug elution 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 receives a guidewire 426 and is configured so that the guidewire 426 can extend outward from the tip portion 412d of the second shaft 412. The drug elution device 400 further includes a balloon 430 which includes a base portion 430p connected to the tip portion 410d of the first shaft 410 and a tip portion 430d connected to the tip portion 412d of the second shaft 412. The balloon 430 is configured to receive the drug from the drug lumen 414 and has a plurality of holes 432 configured to allow the drug to exit the balloon 430. An actuator 408 is operated by the 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 elution device 400 may further include a stop cock 402 connected to the drug port 404.

[0098] The drug elution device 400 includes a handle 406 (e.g., a grip, handgrip, etc.). The handle 406 is configured for the user to grasp, allowing the user to operate the drug elution device 400. The handle 406 may be configured to be held with one hand, allowing the user to perform additional operations with the other hand.

[0099] The handle 406 includes a body 407 (e.g., shell, housing, container, etc.) configured in the same way as the body 107.

[0100] The drug elution device 400 includes a hub 401. In Figure 15, the hub 401 is located separately from the handle 406 and is connected to the 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 side, right side, or proximal end of the handle 406. The hub 401 includes a drug port 404 (e.g., a hole, opening, or throttling) configured in the same way as the drug port 104. The hub 401 may also include a stop cock 402 (e.g., a valve) configured in the same way as 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 can be operated by a user to operate the drug elution device 400. The actuator 408 allows the user of the drug elution device 400 to move the actuator 408 clockwise or counterclockwise around the length of the handle 406 along the longitudinal axis A. L It operates by rotating in a direction parallel to the first shaft 410. As a result of rotating the actuator 408, the second shaft 412 rotates relative to the first shaft 410, compressing the balloon 430 radially and releasing the drug through the multiple holes 432 in the balloon 430. In Figure 15, the actuator 408 is located on top of the handle 406. However, in other embodiments, the actuator 408 may be located below, to the left, or to the right of the handle 406.

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

[0103] As shown in Figure 16, the drug elution device 400 may be an over-the-wire type device in which the guide wire 426 passes through the handle 406 and enters the second shaft 412. In other embodiments, the drug elution device 400 may be a rapid-replacement 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, fluororesin, or other suitable material.

[0105] The length of the first shaft 410 may be in the range of approximately 30 to 300 cm, for example, 30 to 200 cm. The cross-sectional shape of the first shaft 410 may be circular, elliptical, polygonal, rounded polygonal, or other geometric shape. The maximum cross-sectional width of the first shaft 410 (for example, the diameter if the cross-sectional shape is circular) may be in the range of approximately 1 to 15 mm (including the boundary), for example, 2 to 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, space, etc.). The drug lumen 414 penetrates the first shaft 410 longitudinally. 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 have a circular, elliptical, polygonal, rounded polygonal, or other geometric shape. The maximum cross-sectional width of the drug lumen 414 (e.g., the diameter in the case where the cross-sectional shape is circular) is in the range of about 0.5 to 10 mm (including the boundaries), and may ideally be 0.5 to 7 mm.

[0108] The drug elution device 400 also includes a second shaft 412 (e.g., a catheter, tube, pipe, cylinder, conduit, etc.). The second shaft 412 is connected to the actuator 408. The second shaft 412 can be connected to the actuator 408 by bonding with an adhesive, an interlock mechanism, welding, press-fitting, a screw fastener, or other suitable connection configurations. The second shaft 412 can be permanently fixed to the actuator 408 such that the user cannot remove the second shaft 412 from the actuator 408. A part of the second shaft 412 is positioned within the handle 406, whereby the second shaft 412 is moved in a direction parallel to the longitudinal axis A L of the first shaft 410 and may rotate around the longitudinal axis A L of the first shaft 410.

[0109] The second shaft 412 penetrates through the first shaft 410 and is configured to move independently of the first shaft 410. The second shaft 412 is configured such that the tip portion 412d of the second shaft 412 can be positioned more distally than the tip portion 410d of the first shaft 410. The second shaft 412 is configured to receive the guide wire 426 such that the guide wire 426 can extend out from the tip 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, fluororesin, or other suitable material.

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

[0112] The drug elution device 400 also includes a balloon 430. The balloon 430 has a base portion 430p attached to the tip portion 410d of the first shaft 410. The balloon 430 has a tip portion 430d attached to the tip portion 412d of the second shaft 412. The balloon 430 can be attached to the tip portion 410d of the first shaft 410, positioned on the tip portion 410d of the first shaft 410 and the tip portion 412d of the second shaft 412, and can be attached to the tip portion 412d of the second shaft 412 by adhesive bonding or by other suitable connection configurations. In some embodiments, the base portion 430p of the balloon 430 may be attached to the tip portion 410d of the first shaft 410 in the same connection configuration as the tip portion 430d of the balloon 430 can be attached to the tip portion 412d of the second shaft 412. In other embodiments, the base portion 430p of the balloon 430 may be attached to the tip portion 410d of the first shaft 410 in a connection configuration different from that in which 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 drug from the drug lumen 414 of the first shaft 410. Once the drug enters the balloon 430 from the drug lumen 414, the balloon 430 expands to a radially expanded state 434a, and the drug is discharged from the balloon 430 through several holes 432 in the balloon 430.

[0114] Balloon 430 can be made from polyamide, polyester, polyurethane, polyamide elastomer, polyester elastomer, polyurethane elastomer, or other suitable material.

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

[0116] The balloon 430 includes a plurality of holes 432 (e.g., constrictions, openings, slits, etc.) configured to allow the drug to exit the balloon 430. The plurality of holes 432 of the balloon 430 are configured in the same way as the plurality of holes 132 of the balloon 130. When the balloon 430 is in a radially expanded state 434a, the drug passes through the plurality of holes 432 of the balloon 430 and exits the balloon 430 into the blood vessel.

[0117] Actuator 408 can rotate when the user operates it. Rotating actuator 408 causes the tip portion 412d of the second shaft 412 to rotate. When the second shaft 412 rotates relative to the first shaft 410, the first shaft 410 can be held in a fixed position. The second shaft 412 can rotate clockwise or counterclockwise. When 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 Figure 15A, the balloon 430 is in the radially expanded state 434a. In Figure 15B, the balloon 430 is in the radially compressed state 434b. When the balloon 430 is radially compressed from a radially expanded state 434a to a radially compressed state 434b, at least some of the drug that remained inside the balloon 430 but had not yet escaped from the balloon 430 escapes through the multiple holes 432 of the balloon 430 and enters the blood vessels.

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

[0119] General operation of drug elution devices and long and short carrier tubes Figures 17A to 19D show drug elution devices in various operational configurations. Drug elution devices can be used with needles, trocars, guide catheters, short carrier tubes, long carrier tubes, inserters, valves, and / or irrigation devices.

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

[0121] After the needle has accessed the blood vessel, a guidewire (which may be guidewire 126, 226, 326, or 426) may be inserted into the blood vessel by passing the needle through it and positioning it at or near the drug elution target. Imaging may be used to facilitate positioning the guidewire within the target. The needle is then withdrawn from the target, and the guidewire is retained within the target. A portion of the drug elution device 100, 200, 300, or 400 is inserted into the target using the guidewire. The guidewire is then withdrawn from the blood vessel, and the components that have passed over the guidewire are retained within the blood vessel. In other embodiments, the guidewire may remain in the blood vessel, and the guidewire is withdrawn after the drug elution device 100, 200, 300, or 400 is used and withdrawn.

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

[0123] Using the guide catheter 184 allows the balloons 130, 230, 330, or 430 to be advanced within the vessel without encountering intravascular calcification, plaque, or other materials that might obstruct their advancement if the guide catheter 184 is not present. When the guide catheter 184 is used, drawing the balloons 130, 230, 330, or 430 into the guide catheter 184 causes the balloons to be drawn through the guide catheter 184, and the balloons are compressed radially because the guide catheter 184 is located at the tip of the long carrier tube 180 or the short carrier tube 182.

[0124] Figures 17A to 19D show a drug elution device including a long carrier tube 180 (e.g., sheath, guide sheath, cover, etc.) or a short carrier tube 182 (e.g., sheath, guide sheath, cover, etc.). Figures 17A to 19D show a drug elution device 200. In other embodiments, drug elution devices 100, 300, or 400 may be used as the drug elution devices of Figures 17A to 19D. In some embodiments, the length of the long carrier tube 180 (which may be a carrier tube 260) is equal to or longer than the length of the shaft (which may be a shaft 210). In other embodiments, the length of the long carrier tube 180, which may be used with drug elution devices 100, 300, or 400, is equal to or longer than the length of the shaft (which may be a shaft 110, a shaft 210, or a 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% of the length of the balloon 230, preferably 110%. In other embodiments, the length of the short carrier tube 182, which can be used with drug elution devices 100, 300, or 400, is in the range of about 100-120% of the length of the balloon (which may be balloons 130, 330, or 430), preferably 110%. The long carrier tube 180 and the short carrier tube 182 can be used with the guide catheter 184.

[0125] Figures 17A to 17D show a drug elution 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 shafts 110, 210, 310, or the first shaft 410 and the second shaft 412 pass through the short carrier tube 182 first and then through the guide catheter 184. The short carrier tube 182 can be connected to the guide catheter 184 by a snap-fit, Luer-lock connector, or other suitable connection configuration. The short carrier tube 182 can be connected to a handle (which may be handles 106, 206, 306, or 406) by a Luer-lock connector, lock connector, fitting connector, or other suitable connection configuration. In the configuration of Figure 17A, the short carrier tube 182 is not connected to the handle 206. In the configurations of Figures 17B to 17D, the short carrier tube 182 is connected to the handle 206.

[0126] Using a short carrier tube 182 and guide catheter 184 allows for the protection of the balloon (which may be balloon 130, 230, 330, or 430) during balloon insertion, and prevents air from entering the guide catheter 184 because the balloon can be primed before being directly inserted into the guide catheter 184. Using a short carrier tube 182 makes it easier to transfer the balloon into the guide catheter 184.

[0127] In Figures 17A to 17D, a short carrier tube 182 is shown together with the drug elution device 200. In Figure 17A, the balloon 230 and shaft 210 are positioned inside the short carrier tube 182. In Figure 17B, the balloon 230 and shaft 210 are pushed into the guide catheter 184 through the short carrier tube 182. When the balloon 230 is inside the guide catheter 184, it 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 fully outside the guide catheter 184. In Figure 17C, the balloon 230 is inflated and is in a radially expanded state 234a. After drug delivery, the balloon 230 and shaft 210 are retracted, and the balloon 230 is either inside the guide catheter 184 as in Figure 17B, or inside the short carrier tube 182 as in Figure 17A. In Figure 17D, the balloon 230 and shaft 210 are retracted, and the balloon 230 is partially inside the guide catheter 184. When the shaft 210 is retracted, the balloon 230 is compressed relative to the guide catheter 184, and therefore the balloon 230 is compressed radially.

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

[0129] In Figures 18A and 18C, the long carrier tube 180 is shown together with the drug elution device 200. The long carrier tube 180 is connected to the handle 206 and is connected by a Luer lock connector, lock connector, fitting connector, or other appropriate connection configuration. In Figure 18A, the balloon 230 is positioned inside the long carrier tube 180. In Figure 18B, the balloon 230 is pushed forward and is completely outside the long carrier tube 180. In Figure 18B, the balloon 230 is inflated and radially expanded 234a. In Figure 18C, the balloon 230 is retracted and is partially inside the long carrier tube 180. After drug delivery, the balloon 230 may be retracted so that it is inside the long carrier tube 180, as in Figure 18A.

[0130] In other embodiments, the long carrier tube 180 shown in Figures 18A–18C may be used with a drug elution device 100, 300, or 400. In some embodiments, the long carrier tube 180 shown in Figures 18A–18C may be used with a guide catheter 184 shown in Figures 17A–17D instead of a short carrier tube 182. Figures 18A–18C show an over-the-wire type device. In other embodiments, the long carrier tube 180 shown in Figures 18A–18C may be used with a rapid-replacement type device. When the long carrier tube 180 is used with a rapid-replacement type device and a guide catheter 184, the guide wires 126, 226, 336, or 436 are positioned alongside the shafts 110, 210, 310, or the first shaft 410 and the second shaft 412, and inside the guide catheter 184.

[0131] Figures 19A to 19D show a portion of a drug elution device, including a guide catheter 184, an inserter 186 (e.g., a shaft, tube, pipe, cylinder, conduit, etc.), a valve 188 (e.g., a connector, gate, tap, etc.), and a cleaning device 189. In Figures 19A to 19D, the drug elution device is drug elution device 200. In other embodiments, the drug elution device in Figures 19A to 19D may be drug elution devices 100, 300, or 400. The guide catheter 184 may be connected to the inserter 186 by a Luer lock connector or other suitable connection configuration.

[0132] The inserter 186 may be connected to the valve 188 by a Luer lock connector or other suitable connection configuration. The inserter 186 can be passed over the guide wire 226. When the balloon 230 is supplied to the guide catheter 184 using the inserter 186, it may be easier to push the balloon 230 into the guide catheter 184, as without the inserter 186, the balloon 230 may buckle when pressed, or air may enter the guide catheter 184 when the balloon 230 is pressed.

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

[0134] The cleaning device 189 may be used to clean (flush) the inlet 186 and / or guide catheter 184 to remove air from the inlet 186 and to easily and safely transfer the balloon 230 into the guide catheter 184 without air.

[0135] Figures 19A to 19D show the guide catheter 184, the inserter 186, and the valve 188 together with part of the drug elution device 200. In Figure 19A, the shaft 210 is withdrawn through the inserter 186. In Figure 19B, the shaft 210 is withdrawn through the inserter 186 and the balloon 230 is inside the inserter 186. In Figure 19C, the shaft 210 is withdrawn and passes through the valve 188. Figure 19C shows that the inserter 186 is connected to the guide catheter 184 and also to the valve 188. Before or after use of the inserter 186, guide catheter 184, and valve 188, the inserter 186 may not be connected to the guide catheter 184 or the valve 188. The inserter 186 may be connected to the guide catheter 184 by a Luer lock connector or other appropriate connection configuration. The inserter 186 can be connected to the valve 188 by a Luer lock connector or other suitable connection configuration. In Figure 19D, the shaft 210 is pushed in, and the balloon 230 and shaft 210 enter the guide catheter 184.

[0136] In other embodiments, the guide catheter 184, inserter 186, valve 188, and / or cleaning device 189 shown in Figures 19A to 19D may be used with a drug elution device 100, 300, or 400. In other embodiments, the inserter 186, valve 188, and / or cleaning device 189 shown in Figures 19A to 19D may be used with a long carrier tube 180 or a short carrier tube 182. In some embodiments, the inserter 186, valve 188, and / or cleaning device 189 may be used with a rapid exchange type device. In other embodiments, the inserter 186, valve 188, and / or cleaning device 189 may be used with an over-the-wire type device.

[0137] A method of delivering drugs using drug elution devices.

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

[0139] The first method includes the step of providing a drug elution device 100. The drug elution device 100 includes a handle 106 having a drug port 104 configured to receive a drug. The drug elution 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 the tip portion 110d of the shaft 110. The drug elution device 100 further includes a balloon 130 attached to the tip 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 allowing the drug to exit the balloon 130. The drug elution device 100 further includes an anchor 140 connected to the tip portion of the balloon 130. The drug elution device 100 further includes an elastically deformable wire 150 having a tip 150d connected to the tip portion 130d of the balloon 130 and a base portion 150p connected to the guide wire tube 116. The drug elution device 100 further includes a pull wire 128 connected to the anchor 140. The handle 106 further includes an actuator 108 that can be operated by the user to change the balloon 130 from a longitudinally expanded state 134a to a longitudinally compressed state 134b by pulling the pull wire 128. After the balloon 130 is compressed by pulling the pull wire 128, the elastically deformable wire 150 returns the balloon 130 to the longitudinally expanded state 134a. In some embodiments, the drug elution 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 pull wire lumen 118, and the pull wire 128 is located within the pull wire lumen 118 of the shaft 110. The first method is described in relation to the drug elution device 100, but it should be understood that the operation of the first method is similarly applicable to any other device having components similar to those described herein.

[0140] The first method includes the step of inserting the tip portion 110d of the shaft 110 into a blood vessel so that the tip portion 110d of the shaft 110 is located in the blood vessel that is the target of drug elution. The step of inserting the tip portion 110d of the shaft 110 into a blood vessel may include the use of a needle, trocar, guide catheter 184 (Figures 17A-17D), an inserter 186 (Figures 19A-19D), a valve 188 (Figures 19A-19D), and / or a irrigation device 189 (Figures 19A-19D). The drug elution device 100 may be used with a short carrier tube 182 (Figures 17A-17D) or a long carrier tube 180 (Figures 18A-18C).

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

[0142] The first method includes the step of 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 in Figure 1A to a longitudinally compressed state 134b in Figure 1B, and releasing at least some of the drug remaining inside the balloon 130. The pull wire 128 pulls the anchor 140 to compress the balloon 130 longitudinally.

[0143] The first method includes the step of allowing the balloon 130 to return to a longitudinally expanded state 134a as shown in Figure 1C by an elastically deformable wire 150. When the actuator 108 stops operating, the pull wire 128 stops pulling, and the balloon 130 can recover its length as it returns to a longitudinally expanded state 134a. The elastically deformable wire 150 can be expanded to support the longitudinally expanded state 134a of the balloon 130.

[0144] An exemplary second method for delivering a drug intravascularly includes the step of providing a drug elution device 200 using a long carrier tube 180 as a carrier tube 260. The second method also includes the step of inserting the tip portion 210d of a shaft 210 and the tip portion 260d of the carrier tube 260 into a blood vessel. The second method also includes the step of pushing the shaft 210 or pulling the carrier tube 260 so that the tip portion 210d of the shaft 210 and the balloon 230 are outside the carrier tube 260. The second method also includes the step of supplying the drug to the balloon 230 via a drug lumen 214 to inflate the balloon 230 and delivering the drug intravascularly through a plurality of holes 232 in the balloon 230. The second method also includes the step of 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 releasing at least a portion of the drug remaining in the balloon 230.

[0145] A second method includes the step of providing a drug elution device 200. The drug elution device 200 includes a handle 206 having a drug port 204 configured to receive a drug. The drug elution 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 allow the guidewire 226 to extend outward from the tip portion 210d of the shaft 210. The drug elution 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 greater than or equal to the length of the shaft 210. The drug elution device 200 further includes a balloon 230 attached to the tip portion 210d of the shaft 210 and configured to receive a drug from the drug lumen 214, the balloon 230 having a plurality of holes 232 configured to allow the drug to exit the balloon 230. The handle 206 includes an actuator 208 that can be operated by the user to pull the shaft 210, thereby retracting 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 elution device 200 may further include a stop cock 202 connected to the drug port 204. In some embodiments, the drug elution device 200 extends from the proximal end portion 230p of the balloon 230 to the tip portion 230d of the balloon 230, and is aligned with the longitudinal axis A of the shaft 210 when relaxed. L The device may further include one or more elastically deformable wires 256 that are curved radially outward relative to the device. In some embodiments, the drug elution device 200 may further include a ring 270 connected to the tip portion 210d of the carrier tube 260. The elastic modulus of the material of the ring 270 is greater than that of the material of the carrier tube 260. The second method is described in relation to the drug elution device 200, but it should be understood that the operation of the second method is equally applicable to other devices containing components similar to those described herein.

[0146] The second method includes the step of inserting the tip portion 210d of the shaft 210 and the tip portion 260d of the carrier tube 260 into a blood vessel so that the tip portion 210d of the shaft 210 is located in the blood vessel that is the target of drug elution. In some embodiments, during insertion, the tip portion 210d of the shaft 210 may be positioned proximal to the tip portion 260d of the carrier tube 260, as shown in Figure 8A. In other embodiments, during insertion, the tip portion 260d of the carrier tube 260 may be positioned proximal to the tip portion 210d of the shaft 210, as shown in Figure 8B.

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

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

[0149] The second method includes the step of supplying the drug to the balloon 230 via 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. Once the balloon 230 is inflated, it reaches a radially expanded state 234a, as shown in Figure 8C. The pressure that causes the balloon 230 to reach this radially expanded state 234a is maintained by the drug that has entered the balloon 230.

[0150] The second method involves using the actuator 208 to pull the shaft 210, thereby compressing the balloon 230 and changing the balloon 230 from the radially expanded state 234a in Figure 8C to the radially compressed state 234b in Figure 8D, and releasing at least some of the drug remaining in the balloon 230. When the shaft 210 is pulled radially to pull the balloon 230 into the carrier tube 260, the balloon 230 is compressed radially to the radially compressed state 234b.

[0151] In some embodiments, the drug elution device 200 includes one or more elastically deformable wires 256. When the shaft 210 is pulled using the actuator 208 to retract the balloon 230 into the carrier tube 260, the balloon 230 is further compressed by the one or more elastically deformable wires 256 compared to embodiments without the one or more elastically deformable wires 256. In some embodiments, the drug elution device 200 includes a ring 270. When the shaft 210 is pulled using the actuator 208 to retract the balloon 230 into the carrier tube 260, the balloon 230 is retracted into the ring 270 and further compressed compared to embodiments without the ring 270. In some embodiments, the drug elution 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 and retract the balloon 230 into the carrier tube 260, the retraction of the balloon 230 into one or more elastically deformable wires 256 and the ring 270 further compresses the balloon 230 compared to embodiments in which only one or more elastically deformable wires 256 or only the ring 270 is present.

[0152] In some embodiments, the second method includes inserting the guide catheter 184 into the blood vessel before inserting the tip portion 210d of the shaft 210 and the tip 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 tip portion 210d of the shaft 210 and the tip portion 260d of the carrier tube 260 into the blood vessel, the tip 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 so that the tip 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 drawn into the guide catheter 184, and as the balloon 230 is drawn into the guide catheter 184, the balloon 230 is compressed radially to a radially compressed state 234b.

[0153] An exemplary third method for delivering a drug intravascularly includes the step of providing a drug elution device 200 using a short carrier tube 182 as a carrier tube 260. The third method also includes the step of inserting the tip portion 210d of a shaft 210, the tip portion 260d of the carrier tube 260, and a guide catheter 184 into a blood vessel. The third method also includes the step of 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. The third method also includes the step of supplying the drug to the balloon 230 via a drug lumen 214, inflating the balloon 230, and delivering the drug into a blood vessel through multiple holes 232 in the balloon 230. The third method also includes the step of 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 releasing at least a portion of the drug remaining in the balloon 230.

[0154] A third method includes the step of providing a drug elution device 200. The drug elution device 200 includes a handle 206 having a drug port 204 configured to receive a drug. The drug elution 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 outward from the tip portion 210d of the shaft 210. The drug elution 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 shorter than the length of the shaft 210. The drug elution device 200 further includes a balloon 230 attached to the tip 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 can be operated by the user to pull the shaft 210 to retract 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 elution device 200 may further include a stop cock 202 connected to the drug port 204. In some embodiments, the drug elution device 200 extends from the base portion 230p of the balloon 230 to the tip portion 230d of the balloon 230 and is aligned with the longitudinal axis A of the shaft 210 when relaxed. L The device may further include one or more elastically deformable wires 256 that are curved radially outward relative to the device. In some embodiments, the drug elution device 200 may further include a ring 270 connected to the tip portion 210d of the carrier tube 260. The modulus of elasticity of the material of the ring 270 is greater than that of the material of the carrier tube 260. Although the third method is described in relation to the drug elution device 200, it should be understood that the operation of the third method is similarly applicable to other devices containing components similar to those described herein.

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

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

[0157] A third method includes the step of 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 inside the short carrier tube 182, the shaft 210 is pushed forward so that the tip portion 210d of the shaft 210 is inside the guide catheter 184. When the tip portion 210d of the shaft 210 is positioned inside 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] A third method includes the step of supplying the drug to the balloon 230 via 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, it becomes radially expanded 234a, as shown in Figure 8C. The pressure that causes the balloon 230 to become radially expanded 234a is maintained by the drug inside the balloon 230.

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

[0160] In some embodiments, the drug elution device 200 includes one or more elastically deformable wires 256. When the shaft 210 is pulled using the actuator 208 to retract the balloon 230 into the carrier tube 260, the balloon 230 is further compressed by the one or more elastically deformable wires 256 compared to embodiments without the one or more elastically deformable wires 256. In some embodiments, the drug elution device 200 includes a ring 270. When the shaft 210 is pulled using the actuator 208 to retract the balloon 230 into the carrier tube 260, the balloon 230 is retracted into the ring 270 and further compressed compared to embodiments without the ring 270. In some embodiments, the drug elution 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 and retract the balloon 230 into the carrier tube 260, the balloon 230 is further compressed by retracting one or more elastically deformable wires 256 and the balloon 230 into the ring 270, compared to embodiments in which only one or more elastically deformable wires 256 or only the ring 270 is present.

[0161] An exemplary fourth method for delivering a drug into a blood vessel includes the step of providing a drug elution device 300. The fourth method also includes the step of inserting the tip portion 310d of a shaft 310 into a blood vessel. The fourth method also includes the step of supplying the drug to a balloon 330 via a drug lumen 334 and inflating the balloon 330 to deliver the drug into a blood vessel via a plurality of holes 332 in the balloon 330. The fourth method also includes the step of compressing the balloon 330 by pulling a pull wire 328 using an 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 discharging at least a portion of the drug remaining in the balloon 330.

[0162] A fourth method includes the step of providing a drug elution device 300. The drug elution device 300 includes a handle 306 having a drug port 304 configured to receive a drug. The drug elution 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 allow the guidewire 326 to extend out of the tip portion 310d of the shaft 310. The drug elution device 300 further includes a balloon 330 attached to the tip 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 elution device 300 further includes an anchor 340 connected to the tip portion 330d of the balloon 330. The drug elution device 300 further includes a pull wire 328 connected to the anchor 340. The handle 306 includes an actuator 308 that can be operated by the user 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 the inverted state 334c. In some embodiments, the drug elution 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, and the pull wire 328 is located within the pull wire lumen 318 of the shaft 310. Although the fourth method is described in relation to the drug elution device 300, it should be understood that the operation of the fourth method is similarly applicable to other devices containing components similar to those described herein.

[0163] A fourth method includes inserting the tip portion 310d of the shaft 310 into a blood vessel so that the tip portion 310d of the shaft 310 is positioned within the blood vessel to target drug elution. The step of inserting the tip portion 310d of the shaft 310 into a blood vessel includes using a needle, trocar, 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 irrigation device 189 as shown in Figures 19A-19D. The drug elution device 300 may be used with a short carrier tube 182 as shown in Figures 17A-17D or a long carrier tube 180 as shown in Figures 18A-18C.

[0164] A fourth method includes the step of supplying the drug to the balloon 330 via the drug lumen 314, inflating the balloon 330, and delivering the drug into the blood vessel through the multiple holes 332 of the balloon 330. Once the balloon 330 is inflated, the balloon 330 is in a longitudinally expanded state 134a, as shown in Figures 13A and 13B. The pressure required to bring the balloon 330 into this longitudinally expanded state 334a is maintained by the drug entering the balloon 330.

[0165] The fourth method includes the step of 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 in Figures 13A-13B to a longitudinally compressed state 334b ​​(which is the inverted state 334c in Figure 13C), and releasing at least some of the drug remaining inside the balloon 330. The pull wire 328 pulls the anchor 340 to invert and compress the balloon 330. The inversion of the balloon 330 compresses the balloon 330.

[0166] An exemplary fifth method for delivering a drug into a blood vessel includes the step of providing a drug elution device 400. The fifth method also includes the step of inserting the tip portion 410d of a first shaft 410 and the tip portion 412d of a second shaft 412 into a blood vessel. The fifth method also includes the step of supplying a drug to a balloon 430 via a drug lumen 414 and inflating the balloon 430 to deliver the drug into a blood vessel through a plurality of holes 432 in the balloon 430. The fifth method also includes the step of compressing the balloon 430 by rotating the second shaft 412 relative to the first shaft 410 using an 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 in the balloon 430.

[0167] A fifth method includes the step of providing a drug elution device 400. The drug elution device 400 includes a handle 406 having a drug port 404 configured to receive a drug. The drug elution 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 elution 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 receives a guide wire 426 and is configured so that the guide wire 426 can extend outward from a tip portion 412d of the second shaft 412. The drug elution device 400 further includes a balloon 430 which includes a base portion 430p connected to the tip portion 410d of the first shaft 410 and a tip portion 430d connected to the tip portion 412d of the second shaft 412. The balloon 430 is configured to receive the drug from the drug lumen 414 and has a plurality of holes 432 configured to allow the drug to exit the balloon 430. An actuator 408 can be operated by the 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 elution device 400 may further include a stop cock 402 connected to the drug port 404. Although the fifth method is described in relation to the drug elution device 400, it should be understood that the operation of the fifth method is similarly applicable to other devices containing components similar to those described herein.

[0168] A fifth method includes the step of inserting the tip portion 410d of the first shaft 410 and the tip portion 412d of the second shaft 412 into a blood vessel so that the tip portion 410d of the first shaft 410 and the tip portion 412d of the second shaft 412 are positioned in a location that is a target for drug elution within the blood vessel.

[0169] The step of inserting the tip portion 410d of the first shaft 410 and the tip portion 412d of the second shaft 412 into a blood vessel may include the use of a needle, trocar, 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 irrigation device 189 as shown in Figures 19A-19D. The drug elution device 400 may be used with a short carrier tube 182 as shown in Figures 17A-17D, or a long carrier tube 180 as shown in Figures 18A-18C.

[0170] A fifth method includes the step of supplying the drug to the balloon 430 via the drug lumen 414, inflating the balloon 430, and delivering the drug into the blood vessel through the multiple holes 432 of the balloon 430. Once the balloon 430 is inflated, it enters a radially expanded state 434a, as shown in Figure 15A. The pressure that keeps the balloon 430 in the radially expanded state 434a is maintained by the drug entering the balloon 430.

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

[0172] Configuration of an exemplary embodiment It should be noted that the term “example” used herein to describe various embodiments is intended to indicate that such embodiments are possible examples, representations, and / or illustrations of possible embodiments (and is not intended to imply that such embodiments are necessarily exceptional or best examples).

[0173] As used herein, the terms “joining” and similar terms mean that two members are joined to each other directly or indirectly. Such joining may be fixed (e.g., permanent) or movable (e.g., removable or detachable). Such joining may be achieved as a single, integrated body formed integrally with each other, or as two members or two members and additional intermediate members attached to each other.

[0174] It is important to note that the structures and arrangements of various exemplary embodiments are for illustrative purposes only. While this disclosure describes in detail only a few embodiments, those skilled in the art will readily understand that many modifications (e.g., changes in the size, dimensions, structure, shape and proportions of various elements, parameter values, mounting arrangements, material use, color, orientation, etc.) are possible without substantially departing from the novel teachings and advantages of the subject matter described herein. Furthermore, as those skilled in the art will understand, features of one embodiment disclosed herein can be combined with features of other embodiments disclosed herein. Other substitutions, modifications, changes, and omissions can also be made in the design, operating conditions, and arrangements of various exemplary embodiments without departing from the scope of the invention.

[0175] This specification includes details of many specific embodiments, but these should not be interpreted as limiting what may be described in the scope of the invention or claims, but rather as descriptions of features specific to a particular embodiment of a particular invention. Certain features described in this specification in the context of individual 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 individually or in any suitable subcombination in multiple embodiments. Furthermore, even if features are described above as functioning in a particular combination and initially claimed as such, one or more features of a claimed combination may be removed from the combination, and the claimed combination may encompass subcombinations or variations of subcombinations.

[0176] As used herein, terms such as “substantially,” “generally,” and “approximately” are intended to have a broad meaning consistent with the common and accepted usage of those skilled in the art in which the subject matter of this disclosure relates. Those skilled in the art considering this disclosure should understand that these terms are intended to describe the specific features described and claimed, and the scope of those features, without limiting them to the exact numerical range provided. Accordingly, these terms should be interpreted as indicating that any material or insignificant changes or modifications to the subject matter described and claimed are deemed to fall within the scope of the appended claims.

[0177] Furthermore, the term "or" is used in its inclusive (not exclusive) sense in the context of a list of elements, so 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, unless otherwise specified, to be used in contexts that convey that an item, term, etc., could 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). Thus, such conjunctions are not generally intended to suggest, unless otherwise specified, that a particular embodiment must have at least one X, at least one Y, and at least one Z, respectively.

[0178] Furthermore, the use of value ranges (e.g., W1 to W2) in this specification includes the maximum and minimum values ​​unless otherwise specified (e.g., W1 to W2 includes W1 and W2). Furthermore, value ranges (e.g., W1 to W2) do not necessarily require the inclusion of intermediate values ​​unless otherwise specified (e.g., W1 to W2 includes only W1 and W2).

Claims

1. A drug elution device, said drug elution device is A handle including a drug port configured to accept medication, A shaft connected to the handle, A drug lumen configured to receive the drug from the drug port, and A shaft and a guide wire tube, which includes a guide wire tube configured to receive a guide wire and allow the guide wire to extend outward from the tip portion of the shaft, A balloon attached to the tip portion of the shaft and configured to receive the drug from the drug lumen, the balloon having a plurality of holes configured to allow the drug to exit the balloon, An anchor connected to the tip of the balloon, An elastically deformable wire having a tip portion connected to the tip portion of the balloon and a base portion connected to the guide wire tube, The pull wire connected to the anchor, The handle includes an actuator that can be operated by the user to change the balloon from a state of longitudinal expansion to a state of longitudinal compression by pulling the pull wire. After the balloon is compressed longitudinally by pulling the pull wire, when the pull wire is returned to its original position, the balloon returns to its longitudinally expanded state due to the elastically deformable wire. Drug elution device.

2. The drug elution device according to claim 1, wherein the tip of the elastically deformable wire is attached to the tip of the balloon via the anchor.

3. The drug elution device according to claim 1, wherein the elastically deformable wire is spirally shaped.

4. The drug elution device according to claim 1, wherein the elastically deformable wire has a linear shape.

5. The drug elution device according to claim 1, wherein the elastically deformable wire is made of nitinol or stainless steel.

6. The drug dissolution device according to claim 1, wherein the spring constant of the elastically deformable wire changes along the length of the elastically deformable wire.

7. The drug elution device according to claim 1, wherein the drug lumen and the guide wire tube are separated from each other.

8. The drug elution device according to claim 1, wherein the guide wire tube extends through the drug lumen.

9. The drug elution device according to claim 1, further comprising a stop valve connected to the drug port.

10. The drug elution device according to claim 1, wherein the shaft further includes a pull wire lumen, and the pull wire is located within the pull wire lumen of the shaft.

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