Method and apparatus for minimizing excess drug delivery

Abstract

A device and method for suctioning within a patient during delivery of a drug coated therapeutic device to help remove shed drug coating from the patient's blood is described. The drug therapeutic device can be a drug coated balloon, a drug coated stent, or similar device. The device can include an occlusion balloon to help contain the shed drug coating, and suction can be applied proximal, distal, or both proximal and distal of the drug coated balloon during the procedure.

Description

[0001] This application is a divisional application of application number 202080092192.7, filed on December 18, 2020, entitled "Method and apparatus for minimizing excessive drug delivery". Related applications

[0002] This application claims the benefit and priority of U.S. Provisional Application No. 62 / 950,039, filed on December 18, 2019, entitled “Minimizing Drug Deposits During Drug Delivery Procedures,” the entire contents of which are incorporated herein by reference. Technical Field

[0003] This application relates to methods and apparatus for minimizing excessive drug delivery. Background Technology

[0004] Many vascular surgeries utilize drug-coated devices to deliver drugs or similar substances to specific parts of a patient's tissues. These drugs are commonly used to treat or prevent stenosis, restenosis, hardening, or similar vascular conditions.

[0005] In one specific example, a balloon catheter can be used for such drug delivery purposes. The balloon of the catheter includes a drug coating on its outer surface, which, when inflated, presses the drug coating against the inner surface of the blood vessel so that at least some of the drug coating is applied to the tissue in contact. In another example, a stent may include a drug coating on its surface, which is applied to the vascular tissue against which the stent extends, thereby allowing the drug to be absorbed by the tissue.

[0006] While drug coatings on such devices remain an important method for delivering drugs to target areas of the vascular system, a significant portion of the coating can detach or be released during delivery. Once released, the drug can migrate within the patient's bloodstream and vascular system to many unintended locations, potentially causing adverse complications.

[0007] For example, paclitaxel is sometimes incorporated into the drug coating of balloon catheters to treat restenosis or vascular stenosis. Paclitaxel is particularly well-suited for application via balloon catheters due to its high concentration and rapid release from the coating. However, paclitaxel treatment via balloons and stents also increases the risk of death. One possible reason for increased mortality is the release of paclitaxel into the patient's bloodstream, which can then enter organs particularly sensitive to the drug, such as the lungs. In cases of treatment with relatively high concentrations of paclitaxel in the drug coating, measurable paclitaxel concentrations in the patient's blood may remain for 30 days or longer.

[0008] The nature of the coating itself complicates the unintended release of drugs from the drug coating. If the coating is too difficult to remove from the device, very little drug is released into the patient's tissues. If the coating is too easy to remove, most of the drug may end up circulating in the patient's vascular system. Therefore, delivering the required amount of drug with such a coating often requires releasing some or even most of the drug into the bloodstream.

[0009] In fact, the applicant has conducted experiments and analyses, and determined the following statistics: less than 1% of the drug is transferred from the specific balloon coating to the target tissue area, and only about 16% of the coating remains on the balloon after the procedure. Approximately 25% of the drug coating is removed when the balloon catheter is tracked via a guide catheter, and approximately 59% is removed during balloon inflation, deflation, and removal from the catheter. Therefore, approximately 84% of the drug coating is removed from the balloon during the procedure, and the drug is considered to be distributed throughout the patient's vascular system and organs. Depending on the type of drug coating, the concentration of the drug in the coating, and the type of balloon (or other device), a significant amount of drug in the patient's blood can usually be measured some time after treatment.

[0010] For at least these reasons, there is a need to improve treatment methods and devices to reduce the amount of drugs that are unintentionally released into a patient's bloodstream during treatment. Summary of the Invention

[0011] At least one embodiment relates to a device for aspiration within a patient during delivery of a drug-coated therapeutic device to help remove detached drug coating from the patient's bloodstream. The drug-coated therapeutic device may be a drug-coated balloon, a drug-coated stent, or a similar device.

[0012] At least one embodiment relates to a treatment system and method of use that generates aspiration near a distal portion of a drug-coated treatment device, near a proximal portion of a drug-coated treatment device, or at a combination of both locations. Aspiration may occur during distal advancement of the delivery device within a patient's vascular system, during radial expansion / implantation of the drug-coated treatment device, during proximal removal of the drug-coated treatment device, and / or at any point in time between or close to both.

[0013] At least one embodiment relates to a method and treatment system having a balloon catheter having a proximal drug-coated balloon configured to abut against vascular dilation and a distal occlusion balloon configured to occlude the vessel. The treatment system may also include a guiding catheter (or optionally a guiding sheath or guide sheath) configured to aspirate material distal to it during the procedure.

[0014] At least one embodiment relates to a method and treatment system having a balloon catheter having a sequentially inflated balloon. The balloon has a first-inflated distal portion and is generally without a drug coating. The balloon also has a second-inflated proximal portion and includes a drug coating. The treatment system may also include a guiding catheter (or optionally a guiding sheath or guide sheath) configured to aspirate material from its distal end during procedure.

[0015] At least one embodiment relates to a method and treatment system having a balloon catheter with a drug-coated balloon and a guidewire lumen configured for aspiration from the distal end of the balloon catheter. The guidewire lumen may have a relatively large diameter and may be connected to an aspiration source. The balloon catheter may optionally be used with a proximal-positioned occlusion balloon and / or a guiding catheter (or optionally a guiding sheath or guide sheath) configured to also provide aspiration.

[0016] At least one embodiment relates to a method and treatment system having a balloon catheter having an aspiration channel through a drug-coated balloon and selectively connectable to a guide catheter (or optionally to a guide sheath or guide sheath) to generate aspiration therein. The guide catheter is configured to provide aspiration, with its distal end connected to a channel of the aspiration channel, allowing distal aspiration of the drug-coated balloon. Optionally, an occlusion balloon may be advanced through the aspiration channel and used distally on the drug-coated balloon. Attached Figure Description

[0017] These and other aspects, features, and advantages that can be achieved by the embodiments of the present invention will be apparent from and will be explained in the following description of the embodiments of the present invention, with reference to the accompanying drawings:

[0018] Figure 1 This is a side view of the balloon catheter;

[0019] Figure 2 This is a side view of the balloon catheter inside the guiding catheter;

[0020] Figure 3 This is a side view of the double balloon catheter inside the guiding catheter;

[0021] Figure 4 yes Figure 3 Side view of a double-balloon catheter;

[0022] Figure 5 This is a side view of a sequentially inflatable balloon catheter;

[0023] Figure 6 yes Figure 5 Side view of a sequentially inflatable balloon catheter;

[0024] Figure 7 yes Figure 5Side view of a sequentially inflatable balloon catheter;

[0025] Figure 8 yes Figure 5 Side view of a sequentially inflatable balloon catheter;

[0026] Figure 9 yes Figure 5 Side view of a sequentially inflatable balloon catheter;

[0027] Figure 10 yes Figure 5 Side view of a sequentially inflatable balloon catheter;

[0028] Figure 11 This is a side view of a balloon catheter with an enlarged guidewire channel;

[0029] Figure 12 yes Figure 11 Side view of the balloon catheter;

[0030] Figure 13 yes Figure 11 Side view of the balloon catheter;

[0031] Figure 14 This is a side view of the balloon catheter;

[0032] Figure 15 It has a guiding catheter and an occlusion catheter. Figure 14 Side view of the balloon catheter. Detailed Implementation

[0033] Specific embodiments of the invention will now be described with reference to the accompanying drawings. However, the invention can be embodied in many different forms and should not be construed as limited to the embodiments described herein; rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the invention to those skilled in the art. The terminology used in the detailed description of the embodiments shown in the drawings is not intended to limit the invention. In the drawings, similar numbers denote similar elements. Although different embodiments are described, features of each embodiment can be used interchangeably with those of other described embodiments. In other words, any feature of each embodiment can be mixed and matched with each other, and embodiments need not be strictly interpreted as including only the features shown or described.

[0034] Although the terms “medicine” and “medication coating” are used in this specification, these terms are intended to include any therapeutic agent, compound, chemical or other material that may be incorporated into the coating of the device.

[0035] As previously mentioned, during treatment, drug-coated devices (such as balloon catheters and stents) often release unwanted amounts of drug coating into the bloodstream, which then circulates through the patient's vascular system. Much of this unwanted drug release can occur when the device (such as a balloon or stent) is tracked via an external guide catheter, during the device's expansion within the patient's blood vessels, during the device's contraction, and during catheter retraction.

[0036] exist Figure 1 and Figure 2 This provides a concrete example of such undesirable drug coating loss. Figure 1 A typical balloon catheter 100 is shown, having a drug-coated balloon 106 located distal to an elongated catheter body 102. The catheter body 102 also includes guidewire channel 104 openings proximal and distal to the balloon 106, and a balloon inflation lumen (not shown) communicating between the interior of the balloon 106 and a proximal catheter hub 108 to allow balloon inflation. While this guidewire channel 104 configuration is commonly referred to as a rapid exchange catheter type, over-the-wire style catheters including guidewire channel openings proximal to the catheter can also be considered.

[0037] refer to Figure 2 The balloon catheter 100 is typically extended from the overlying guiding catheter 110, positioning the drug-coated balloon 106 near the vessel wall of the target treatment area. Inflation medium is injected into the inflatable lumen, causing the drug-coated balloon 106 to inflate and contact the vessel wall, with at least some of the drug coating delivered to the vessel wall. Finally, the drug-coated balloon 106 is deflated and retracted into the overlying guiding catheter 110. Note that although a guiding catheter is used in this specification, it should be understood that a guiding sheath or guide device sheath may be used alternatively as this component.

[0038] like Figure 2 As shown, during this treatment procedure, most of the drug coating 109 is released from the balloon 106, where it mixes with the patient's blood and circulates through at least a portion of the patient's vascular system and organs, such as the heart and lungs. Depending on the type of drug, the amount released from the balloon, the treatment site, and other factors, significant and adverse drug concentrations may remain in the patient's blood and / or organs for days or even weeks after the treatment procedure.

[0039] This specification describes several therapeutic devices and methods for reducing unwanted accumulation of medication removed from the coating of a therapeutic device. While different embodiments of balloon catheters are described primarily, it should be understood that these devices and methods can be similarly adapted for use with other drug-coated devices, such as stents, or even uncoated devices that deliver medication directly to a target area (e.g., exudative balloons configured to drain medication from their orifices).

[0040] Figure 3 and Figure 4 One embodiment of a treatment system 120 is shown, configured to aspirate or remove at least some of the drug coating released into a patient's vascular system during treatment. The treatment system 120 includes a balloon catheter 121 having an occlusion balloon 124 configured to occlude the distal portion of a target blood vessel in the patient before inflation of a drug-coated balloon 126. As discussed in detail below, during the procedure, blood containing any free or released drug coating is aspirated and removed from the patient to prevent circulation through the patient's blood vessels.

[0041] The occlusion balloon 124 is located distal to the drug-coated balloon 126 on the elongated body 122 of the balloon catheter 121. Balloons 124 and 126, along with the elongated body 122, are configured to allow the occlusion balloon 124 to be fully inflated before significant inflation of the drug-coated balloon 126, and to allow the occlusion balloon 124 to deflate after the drug-coated balloon 126 deflates. This inflation sequence helps maintain vascular occlusion during the portion of the process in which the drug coating is most likely to migrate into the patient's bloodstream; therefore, the occlusion balloon 124 helps prevent distal migration of the drug from the drug-coated balloon 126, and / or, as will be explained in more detail, helps provide a seal for subsequent aspiration procedures. In one example, this inflation sequence can be achieved via two separate inflation lumens within the elongated body 122, each inflation lumen connected to a separate inflation lumen and inflation port (e.g., ports 123A and 123B) at the proximal end of the elongated body 122.

[0042] In another example, balloons 124 and 126 may be connected to a single inflation lumen in body 122. To create the desired inflation sequence, occlusion balloon 124 may be made of a material that is easier to inflate than drug-coated balloon 126. In one specific example, occlusion balloon 124 may be made of a relatively inelastic material that increases in diameter with almost no resistance (e.g., similar to inflating a plastic bag), while drug-coated balloon 126 may be made of a relatively elastic material that stretches during inflation to provide resistance (e.g., similar to a rubber party balloon). Thus, as the pressure in the inflation lumen increases, occlusion balloon 124 inflates first, drug-coated balloon 126 inflates next, drug-coated balloon 126 deflates first, and occlusion balloon 126 deflates last.

[0043] In any of the balloon inflation examples described above, the proximal end of the elongated body 122 (e.g., a catheter hub) may be connected to one or more manually driven syringes to induce inflation or connected to a motorized inflation device. In the case of a motorized inflation device, it may be necessary to provide and maintain various pressure levels within the inflation lumen and balloon, especially in the example of a single inflation lumen described above, because these different pressure levels within the inflation lumen determine the inflation sequence of balloons 124 and 126 (e.g., low pressure may only inflate the occluded balloon 124, while high pressure may inflate the drug-coated balloon 126). In this regard, the motorized inflation device may include an algorithm configured to provide a predetermined sequence of pressure levels to achieve the desired balloon inflation and deflation sequence.

[0044] As previously described, the treatment system 120 is also configured to provide aspiration to remove any blood near the drug-coated balloon containing any removed drug coating 128. In this embodiment, this aspiration can be provided via an external guiding catheter 130 or a sheath through which the balloon catheter 121 is positioned. The guiding catheter 130 may have a generally tubular body and may include an aspiration port 132 leading to the lumen of the guiding catheter 130, thereby allowing a vacuum source (e.g., syringe 136 or pump) to be connected thereto. When the vacuum source is activated, it draws blood from the distal end of the guiding catheter 130 into its lumen and toward the vacuum source. Because the guiding catheter typically includes a hemostatic valve at its proximal end (e.g., around the balloon catheter 121), air is prevented from being drawn into the lumen of the guiding catheter 130. In other words, the guiding catheter 130 is configured to allow aspiration only from its distal end toward the vacuum source, and not from the proximal end of the guiding catheter 130. In this embodiment, the continued occlusion of the blood vessel helps prevent the displaced drug particles from moving through the patient's vascular system before the guiding catheter 130 can aspirate these drug particles from the patient's body.

[0045] When using syringe 136 as a vacuum source, the physician can initially keep stopcock valve 134, located between syringe 136 and guide catheter 130, in the closed position. The plunger of syringe 136 can be withdrawn to create vacuum pressure, and then stopcock valve 134 can be opened when aspiration is needed inside the patient. Blood from the area near drug-coated catheter 126 is then drawn into guide catheter 130 and further into syringe 136. Depending on the location of the procedure, the nature of the drug coating, and other factors, different amounts of blood may be aspirated. In many cases, a 30cc or 60cc syringe or aspiration volume may be appropriate.

[0046] In one example, the treatment system 120 can be used by first advancing a guidewire into the patient's vascular system so that its distal end is near the desired treatment location within the vessel. Next, a guiding catheter 130 can be advanced over the guidewire so that its distal end is near the desired treatment location. Then, a balloon catheter 121 is advanced over the guidewire through its guidewire channel 122A to position a drug-coated catheter 126 at the desired target location and to position an occlusion balloon 124 distal to the target location. Optionally, the guidewire can be retracted before balloons 124 and 126 are inflated.

[0047] Next, the occlusion balloon 124 is inflated to occlude the blood vessel and essentially prevent blood flow through it. Once the vessel is blocked, the drug-coated balloon 126 is inflated, causing the drug coating 128 on the balloon 126 to contact the inner surface of the blood vessel, delivering the drug coating or delivering it to the vascular tissue, such as... Figure 3 As shown.

[0048] As previously described, the majority of the drug coating 128 can be removed or released through the processes of tracking the balloon catheter 121 via the guide catheter 130, inflating the drug-coated balloon 126, deflating the drug-coated balloon 126, and other movements during this process. In this regard, a physician can perform aspiration via the guide catheter 130 when the drug-coated balloon 126 is deflated (partially or completely). However, aspiration may also be applied throughout the tracking and inflation process. Furthermore, this aspiration can be generated, among other techniques, by opening a valve 134 connected to a syringe 136 with a constricting plunger, and other techniques.

[0049] like Figure 4As shown, blood and the removed drug coating 128 are drawn into the guiding catheter 130, the outflow port 132, and the syringe 136 (although some blood and coating may remain in the guiding catheter 130). In one example, a physician may remove 30 to 60 milliliters of blood from the area between the occlusion balloon 125 and the distal end of the guiding catheter 130. Finally, the drug-coated balloon 126 is fully deflated (if not already fully deflated), and the occlusion balloon 124 is also fully deflated, allowing the physician to withdraw the balloon catheter 121 proximally back into the guiding catheter 130 to complete the procedure. Thus, much of the removed drug coating that would otherwise circulate in the patient's vascular system is removed from the patient.

[0050] Figures 5-10 Another embodiment of a balloon catheter 140 is shown, which has a single sequentially inflatable balloon 146 that can be partially inflated first to occlude a portion of a patient's blood vessel, and then fully inflated to deliver a therapeutic agent to the vascular tissue. Similar to the previously described balloon catheter 121, this allows for occlusion of a portion of a patient's blood vessel to prevent the migration of displaced medication, followed by aspiration to remove any displaced medication from the patient's bloodstream.

[0051] like Figure 5 and Figure 6 As shown, the balloon catheter 140 includes an elongated body 142 and a balloon 146, the elongated body 142 having a guidewire channel 144 (e.g., a quick-exchange, single-rail guidewire channel) extending at least through its distal portion, and the balloon 146 being disposed near the distal end of the elongated body 142.

[0052] The drug coating is positioned on the proximal balloon portion 146B to enable drug delivery to the patient's blood vessel, while the distal balloon portion 146A has virtually no drug coating. Therefore, the distal balloon portion 146A can expand to occlude the vessel, and if any, the drug coating on this portion is rarely displaced and moves distally to the catheter 140.

[0053] like Figures 7-10 As shown, the balloon catheter 140 is configured to sequentially inflate and deflate the distal balloon portion 146A and the proximal balloon portion 146B. Specifically, the distal balloon portion 146A is inflated first, followed by the proximal balloon portion 145B; the distal balloon portion 146A is deflated, and then the proximal portion 145B is deflated.

[0054] This continuous balloon inflation can be achieved using several different techniques. For example, each portion 146A, 146B of the balloon 146 can be composed of a material that allows the distal balloon portion 146A to inflate at a lower pressure than the proximal balloon portion 146B (i.e., easier to inflate). The difference in anti-inflation resistance between the two portions 146A, 146B can be achieved by using different materials, different material thicknesses, additional material layers / bands on the proximal portion 146B, any combination of these techniques, or portions of similar techniques. The elongated body 142 may also include a single inflation lumen communicating with the balloon 146 to allow for sequential inflation / deflation. As with the previous embodiments, the inflation mechanism can be a manually driven device, such as a syringe or a motorized inflation device, which can be programmed to achieve and maintain the specific, desired pressure required for the inflation sequence.

[0055] In another example, balloon 146 may include a mechanism for delivering and withdrawing inflation media at different rates to distal balloon portion 146A and proximal balloon portion 146B to induce sequential inflation. This can be achieved by a larger distal inflation port and a smaller proximal inflation port on an elongated body 142 below balloon 146, partial or full walls of the internal partitions 146A, 146B, distal and proximal inflation ports with valves having different opening amounts, separate inflation chambers within the elongated body 142, or a combination of these features.

[0056] The balloon catheter 140 can be used in the following example procedure. First, a guidewire is advanced into the patient so that its distal end is near the target area of ​​the patient's blood vessel. Next, a thin, tubular guiding catheter 148 is advanced over the guidewire so that its distal end is near the target area. Next, the balloon catheter 140 is advanced over the guidewire and through the lumen of the guiding catheter 148 so that its distal end and the balloon 146 are located in the target area of ​​the patient's blood vessel. Preferably, the distal portion 146A is located distal to the target area, while the proximal portion 146B of the drug-coated portion is circumferentially positioned within the target area of ​​the blood vessel.

[0057] refer to Figure 7 The distal portion 146A of the balloon 146 is initially inflated to completely or substantially occlude the vessel. (As...) Figure 8 As shown, the proximal portion 146B of the drug coating is inflated, causing its drug coating surface to expand relative to the target area of ​​the blood vessel to transport or deliver a portion of its drug.

[0058] refer to Figure 9The proximal balloon portion 146B is partially or completely deflated, leaving any displaced drug coating 143 in the blood captured near the balloon 146. Aspiration is then performed via the guide catheter 148, but may also be performed prior to this. This aspiration can be applied in a similar manner and using a similar device, as described above with the guide catheter 130.

[0059] Finally, as Figure 10 As shown, balloon 146 can be fully inflated and retracted into guiding catheter 148, thereby enabling the procedure to be completed. During this complete deflation and balloon retraction, aspiration may optionally continue to further remove any drug coating that may have been dislodged.

[0060] Figures 11-13 Another embodiment of a balloon catheter 150 is shown, configured to allow aspiration through its distal end to aid in the removal of partially displaced drug coating 156. This distal aspiration may optionally be used in conjunction with proximal aspiration from a guiding catheter (such as the previously described guiding catheters 130 and 148).

[0061] The balloon catheter 150 may include an elongated body having a guidewire channel extending through the body, the guidewire channel also configured to serve as an aspiration channel. The channel may have a proximal opening 157 in a hub 151 of the catheter allowing the guidewire to enter the channel and a distal opening 158 allowing the guidewire to exit the channel. The catheter hub 151 may have an aspiration port 153, which also communicates with the guidewire channel and can be connected to a vacuum source, such as a syringe 136. A hemodynamic valve in the proximal portion of the guidewire channel seals the proximal end of the channel, so that when a vacuum pressure is applied to the guidewire channel, it causes aspiration or withdrawal of the distal opening 158 of the balloon catheter 150.

[0062] Optionally, the guidewire channel diameter is slightly larger than a typical guidewire channel to prevent blockage during aspiration and to ensure that blood can be removed at the desired rate. In one example, the guidewire / aspiration channel to inflatable balloon 154 diameter ratio ranges from about 0.2 to 0.8. Table 1 shows some example ratios and measurements of prior art guidewire lumen and larger guidewire channel dimensions according to this embodiment. For example, the ratio of a guidewire lumen diameter of 0.36 mm to a balloon diameter of 2 mm is 0.18, while the ratio of a balloon diameter of 1.22 mm to a balloon diameter of 2 mm is 0.61.

[0063] Table 1

[0064]

[0065] The balloon catheter 150 can be used in the following example procedure. First, a guidewire is advanced into the patient so that its distal end is near the target area of ​​the patient's blood vessel. Next, a thin, tubular guiding catheter (similar to guiding catheter 130 or guiding catheter 148) is advanced over the guidewire so that its distal end is near the target area. Next, the balloon catheter 150 is advanced over the guidewire and through the lumen of the guiding catheter so that its distal end and the balloon 154 are located in the target area of ​​the patient's blood vessel.

[0066] refer to Figure 12 The balloon 154 is inflated so that its drug coating 156 is pressed against the tissue in the target area. As the balloon 154 is withdrawn from the guiding catheter and inflated, aspiration can be performed from the guiding catheter (as described in previous embodiments) and / or from the distal opening 158 of the guidewire lumen to help collect any free drug coating 156 that has been dislodged during this process.

[0067] refer to Figure 13 The balloon 154 can be deflated after the required amount of time of contact with the target area. Since this deflation may cause further removal of the drug coating (shown as element 159 in the blood), further aspiration helps to capture and remove drug particles and blood from the distal end of the catheter 150. Aspiration according to this embodiment can only be performed at different times throughout the process through the distal opening 158, or in combination with aspiration from the guiding catheter.

[0068] When aspiration is performed from the distal opening 158 and the guiding catheter, different vacuum pressures may need to be applied from each source, depending on the expected aspiration power. For example, a lower, gentler vacuum pressure may be needed from the distal opening 158 to prevent vascular collapse in the patient, while a relatively stronger vacuum source from the guiding catheter may be used to resist vascular collapse caused by the balloon catheter extending distally and outward from the guiding catheter opening.

[0069] Figure 14 and 15 Another embodiment of the treatment system is shown, which allows for selective proximal and distal aspiration of the drug-coated balloon 162 during surgery. Specifically, the drug-coated balloon catheter 160 is configured to couple or seal with the distal opening of a guiding catheter 130 connected to the aspiration source. Figure 15 As shown, this arrangement allows the guide catheter 130 to aspirate from the proximal end of the balloon 162 when disconnected from the balloon 162, or to aspirate from the distal end of the balloon 162 through the channel 164 when engaged with the proximal end of the balloon 162.

[0070] In one embodiment, the drug-coated balloon catheter 160 includes an elongated catheter body 168, the distal end of which is connected to an enlarged tubular portion having a channel 164. The balloon 164 is connected to the enlarged tubular portion and configured to be inflated through an inflatable lumen within the elongated catheter body 168.

[0071] Balloon 162 is configured to inflate such that the distal balloon portion 162A has a larger inflation diameter, while the proximal balloon portion 162B has a relatively smaller inflation diameter. The inflation diameter of the distal balloon portion 162A is preferably large enough to contact the inner diameter of the target vessel, thereby allowing delivery of some of the drug coating 166. The inflation diameter of the proximal balloon portion 162B has a diameter approximately the size of the inner diameter of the guiding catheter 130 (e.g., slightly larger, equal to, or slightly smaller than the lumen). This size allows the inflated proximal balloon portion 162B to be inserted into and engage the interior of the guiding catheter 130. Thus, when aspiration is applied to the guiding catheter 130, it continues to flow through the proximal opening 164A of the channel 164 and out from the distal opening 164B. Alternatively, the proximal balloon portion 162B may inflate into a conical or ramp shape, increasing in the distal direction, so that it can "wedge" into the lumen of the guiding catheter 130.

[0072] Optionally, the channel 164 has a sufficiently large diameter to accommodate the passing occluded balloon catheter 170, allowing occlusion of the vascular region distal to the balloon 162, similar to previous embodiments. In one example, the diameter of the channel 164 is large enough to accommodate the balloon 174, and therefore the inner diameter is approximately 0.050". In this respect, the diameter of the channel 164 can provide ample spacing around the body 172 of the balloon catheter 170, allowing aspiration to be performed through the channel 164 when the balloon catheter 170 is also located within the channel 164.

[0073] The balloon catheter 160 can be used in the following example procedure. First, guidewire 111 is advanced into the patient so that its distal end is near the target area of ​​the patient's blood vessel. Next, a thin tubular guiding catheter 130 is advanced over guidewire 111 so that the distal end of guiding catheter 130 is near the target area. Next, drug-coated balloon catheter 160 is advanced over guidewire (through channel 164) and through the lumen of guiding catheter 130 so that its distal end and balloon 162 are located in the target area of ​​the patient's blood vessel.

[0074] Optionally, the occlusion balloon catheter 170 is advanced over the guidewire 111 and through the channel 164 of the drug-coated balloon catheter 160. The occlusion balloon 174 is then inflated to contact and occlude the patient's vascular region distal to the target area. This arrangement is described in [reference needed]. Figure 15 .

[0075] Next, the balloon 162 of the drug-coated catheter 160 is inflated so that the drug coating 166 on its distal balloon portion 162A contacts the target area of ​​the patient's blood vessel. During this time, the distal end of the guiding catheter 130 can be positioned close to the balloon 162 and aspiration can be performed in a manner previously discussed in other embodiments.

[0076] The distal end of the guiding catheter 130 can then be moved distally to the balloon 162 such that its lumen surrounds and overlaps the smaller diameter portion 162B of the balloon 162. Then, if the guiding catheter 130 is not already activated, aspiration is activated through the guiding catheter 130, creating aspiration in the space between the occluded balloon 174 (if present) and the drug-coated balloon 162. Thus, any detached drug coating in the blood located between the two balloons 162, 174 is partially or completely removed.

[0077] Once the required amount of aspiration has been achieved, the drug-coated balloon 162 is deflated and withdrawn into the guiding catheter 130. Similarly, the occlusion balloon 174 is deflated and withdrawn into the guiding catheter 130, and the procedure can be completed.

[0078] In alternative embodiments, any drug-coated balloon and / or occlusion balloon of the previously described embodiments may be replaced with a non-inflatable device, such as an inflatable mesh device.

[0079] In alternative embodiments, the drug-coated balloon and balloon catheter of the previously described embodiments can be replaced with a drug-coated stent (or similar implantable device) and stent delivery catheter.

[0080] In another embodiment, the drug-coated balloon and balloon catheter of the previously described embodiments can be replaced by a balloon catheter having the ability to “leak” or slowly release liquid drugs from pores on its balloon surface.

[0081] The procedures described in this embodiment can be performed at many different locations within the patient's vascular system, but may be particularly useful for procedures involving the arms, legs, and torso.

[0082] Although the invention has been described with reference to specific embodiments and applications, those skilled in the art can generate additional embodiments and modifications based on this teaching without departing from or exceeding the spirit or scope of the claimed invention. Therefore, it should be understood that the accompanying drawings and descriptions are provided by way of example to facilitate understanding of the invention and should not be construed as limiting the scope of the invention.

Claims

1. A vascular treatment system, comprising: Balloon catheters, comprising: Slender body; A drug-coated balloon is attached to the distal end of an elongated body; the drug-coated balloon includes a distal portion and a proximal portion, wherein the proximal portion includes a drug coating, and wherein the distal portion is inflated prior to the proximal portion; and A drug coating is applied to a drug-coated balloon. Guiding catheter, comprising: The guiding catheter body has a catheter lumen; and The suction port is connected to the lumen of the catheter.

2. The vascular treatment system of claim 1, wherein the distal portion of the drug-coated balloon is inflated at a lower pressure than the proximal portion of the drug-coated balloon.

3. The vascular treatment system of claim 1, wherein the distal portion of the drug-coated balloon has a different thickness than the proximal portion of the drug-coated balloon.

4. The vascular treatment system according to claim 1, wherein only one of the distal portion or the proximal portion of the drug-coated balloon has a reinforcing layer.

5. The vascular treatment system of claim 1, wherein the distal portion of the drug-coated balloon comprises a different material than the proximal portion of the drug-coated balloon.

6. The vascular treatment system of claim 1, wherein the distal portion of the drug-coated balloon is inflated before the proximal portion of the drug-coated balloon by one or more of the following features: variable balloon thickness, reinforcing band, and a proximal portion comprising a first material and a distal portion comprising a second material.

7. The vascular treatment system of claim 1, wherein the distal portion of the drug-coated balloon is inflated at a different rate than the proximal portion of the drug-coated balloon.

8. The vascular treatment system of claim 1, wherein the distal portion of the drug-coated balloon includes a larger distal inflation port, and the proximal portion of the drug-coated balloon includes a smaller inflation port.

9. The vascular treatment system of claim 1 further includes a portion of the wall within the drug-coated balloon located between the distal portion and the proximal portion of the drug-coated balloon.

10. The vascular treatment system of claim 1, wherein the distal portion of the drug-coated balloon includes a distal inflation port valve, and the proximal portion of the drug-coated balloon includes a proximal inflation port valve; wherein the opening amount of the distal inflation port valve is different from that of the proximal inflation port valve.

11. The vascular treatment system of claim 1, wherein the distal portion of the drug-coated balloon is inflated before the proximal portion of the drug-coated balloon by one or more of the following features: wherein the distal portion of the drug-coated balloon includes a larger distal inflation port, and the proximal portion of the drug-coated balloon includes a smaller inflation port; within the drug-coated balloon, there is a partial wall between the distal and proximal portions of the drug-coated balloon; and wherein the distal portion of the drug-coated balloon includes a distal inflation port valve, and the proximal portion of the drug-coated balloon includes a proximal inflation port valve, wherein the opening amount of the distal inflation port valve differs from the opening amount of the proximal inflation port valve.

12. The vascular treatment system of claim 1, wherein the proximal portion deflates before the distal portion.

13. A vascular treatment system, comprising: Balloon catheters, comprising: Slender body; A drug-coated balloon, attached near the distal end of an elongated body; and A drug coating is applied to a drug-coated balloon. Guiding catheter, comprising: A slender, tubular body with an internal guiding conduit lumen; and A suction port, which is connected to the lumen of the guide tube and further configured to be connected to a vacuum source; The guiding catheter is configured to aspirate blood near the drug-coated balloon during treatment; The balloon catheter includes a guidewire channel opening distal to a drug-coated balloon and is configured to connect to an aspiration source and provide aspiration at the guidewire channel opening.

14. The vascular treatment system of claim 13, wherein the ratio between the diameter of the inflatable drug-coated balloon and the diameter of the guidewire channel is in the range of 0.2 to 0.

8.

15. A vascular treatment system, comprising: Balloon catheters, comprising: Slender body; A drug-coated balloon, attached near the distal end of an elongated body; and A drug coating is applied to a drug-coated balloon. Guiding catheter, comprising: A slender, tubular body with an internal guiding conduit lumen; and A suction port, which is connected to the lumen of the guide tube and further configured to be connected to a vacuum source; The guiding catheter is configured to aspirate blood near the drug-coated balloon during treatment; The balloon catheter also includes an occlusion balloon, which is connected to the distal side of the drug-coated balloon on the elongated body. The balloon catheter is configured to first inflate the occluded balloon and then inflate the drug-coated balloon.

16. The vascular treatment system of claim 15, wherein the balloon catheter is configured to first deflate the drug-coated balloon and then deflate the occlusion balloon.

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