Isolated endovascular procedures with perfusion bypass

Abstract

To provide medical devices and treatment for treating intravascular lesions.SOLUTION: A catheter-based system is provided having two occlusion elements 102, 104 and a perfusion lumen, where the perfusion lumen has a distal opening 134 distal to the occlusion elements and a proximal opening 142 proximal to the occlusion elements. The perfusion lumen can allow blood to flow between the distal and proximal openings through a treatment site, while the blood remains isolated from fluids in the treatment site. The system further includes a treatment lumen, where the treatment lumen has a proximal opening accessible by a user to provide aspiration, drug delivery, mechanical device delivery, or other treatment means into the vasculature and a distal opening positioned between the two occlusion elements and in communication with fluids at the isolated treatment site.SELECTED DRAWING: Figure 1A

Description

[Technical field]

[0001] The present invention relates generally to medical devices and procedures for treating lesions in blood vessels, and more particularly to catheter-based procedures for lesions associated with intracranial atherosclerosis (ICAD). [Background technology]

[0002] Atherosclerosis results from lesions that narrow and reduce the space within the lumen of blood vessels. Such lesions are usually composed of plaque, which can be fat, cholesterol, calcium, or other components of blood. Severe blockages or occlusions can impede the flow of oxygen-rich blood to various different organs and parts of the body, resulting in cardiovascular disorders such as heart attacks or strokes. The narrowing, or stenosis, of blood vessels increases the risk that blood clots and other emboli can become lodged in such locations, especially in neurovasculature, where the diameter of the vessels is already small. ICAD is the narrowing of these arteries and vessels that supply blood to the brain, and is the most common proximate cause of ischemic stroke.

[0003] Treatment of vascular occlusions may include medical procedures such as surgical endarterectomy, angioplasty, and stent placement, along with the use of drugs such as anticoagulants or antiplatelet agents. A physician may select one or more treatment methods based on the difficulty of administering the treatment, the potential effectiveness of the treatment, and the risks associated with the treatment. Factors influencing these considerations may include the degree of stenosis, the shape of the treatment target site (i.e., arterial trunk, branch, etc.), the ease of access to the treatment target site, and the general condition of the patient. When drugs are delivered into a blood vessel, there is a possibility that the drug may migrate away from the treatment site, compromising the effectiveness of the treatment at that site and / or adversely affect the blood vessel to which it has migrated. Mechanical procedures may rupture or fragment the lesion. Such fragments include, but are not limited to, clots, plaque, and other thrombotic debris. The fragments may result in vascular occlusion causing widespread stroke or death. Particularly in the case of ICAD, prolonged treatment may increase the likelihood of the lesion rupturing and / or prolong the cessation of blood flow to the neurovasculature, thereby increasing the likelihood of irreversible brain damage. Summary of the Invention [Problem to be solved by the invention]

[0004] Accordingly, applicants have recognized a need for systems and devices to continue to address and improve the treatment of intravascular occlusions, specifically ICAD. [Means for solving the problem]

[0005] In general, one object of the present invention is to provide a catheter-based system having two occlusion elements and a perfusion lumen having a distal opening distal to the occlusion element and a proximal opening proximal to the occlusion element. The occlusion element can be expanded to block blood flow distal to an intravascular treatment site and also block blood flow proximal to the treatment site, thereby isolating the treatment site. The perfusion lumen can allow blood to flow through the treatment site between the distal and proximal openings while keeping the blood isolated from fluids within the treatment site. The system further includes a treatment lumen having a proximal opening accessible by a user to provide suction, drug delivery, mechanical device delivery, or other treatment means within the vasculature, and a distal opening disposed between the two occlusion elements and in communication with fluids at the isolated treatment site.

[0006] An exemplary catheter for performing an endovascular procedure can include an elongate tubular body, a proximal expandable occlusion element, a distal expandable occlusion element, a first fluid lumen, and a second fluid lumen. The catheter can further include one or more inflation lumens.

[0007] The elongate tubular body can have a proximal end, a distal end, and a length therebetween. The length can be sized such that the proximal end is accessible by a user (e.g., outside the patient's body) while the distal end is positioned near the endovascular treatment site. The elongate tubular body can include some or all of the first fluid lumen, the second fluid lumen, and / or some or all of the one or more inflation lumens.

[0008] The proximal expandable occlusion element may be disposed on the tubular body. The proximal expandable occlusion element may be expandable from a collapsed configuration sized to pass through a guide catheter to an expanded configuration sized to occlude a blood vessel. The proximal expandable occlusion element may be expanded from the collapsed configuration to the expanded configuration via one or more inflation lumens. Alternatively, the proximal expandable occlusion element may be self-expandable or expanded by other means as one of ordinary skill in the art will recognize and understand following the teachings of the present disclosure.

[0009] The distal expandable occlusion element can be disposed on the tubular body distally relative to the proximal balloon. The distal expandable occlusion element can be expandable from a collapsed configuration sized to pass through a guide catheter to an expanded configuration sized to occlude a blood vessel. Alternatively, the distal expandable occlusion element can be self-expandable or expanded by other means as those skilled in the art will recognize and understand following the teachings of the present disclosure.

[0010] The first fluid lumen can include a proximal opening and a distal opening. The proximal opening can be disposed near a proximal end of the elongated tubular body. The distal opening can be disposed distal to the proximal expandable occlusion element and proximal to the distal expandable occlusion element. The first fluid lumen can be integral with the elongated tubular body. The distal opening of the first fluid lumen can include a skive within the elongated tubular body. The first fluid lumen can be sized for delivery of a drug suitable for treating the intravascular lesion. The first fluid lumen can be coated with a coating effective to inhibit adhesion of a sealant effective to seal the intravascular lesion. Additionally or alternatively, the first fluid lumen can be configured to aspirate debris from the isolated treatment site. Additionally or alternatively, the first fluid lumen can be configured to deliver saline or other irrigation fluid to the isolated treatment site.

[0011] The second fluid lumen can be separate from the first fluid lumen, meaning that the first and second fluid lumens are not in fluid communication with each other. The second fluid lumen can include a proximal opening that is disposed near and proximal to the proximal occlusion element. The second fluid lumen can include a distal opening that is disposed near and distal to the distal expandable occlusion element. The second fluid lumen can be integral with the elongate tubular body. The proximal opening of the second fluid lumen can include a skive in the elongate tubular body. The second fluid lumen can provide a continuous flow path from its proximal opening to its distal opening.

[0012] The one or more inflation lumens can be in communication with the proximal and / or distal expandable occlusion elements to provide a flow path for inflating and / or deflating the proximal and / or distal expandable occlusion elements. The one or more inflation lumens can extend through a majority of the length of the tubular body.

[0013] An exemplary method for delivering a drug into an isolated blood vessel may include one or more of the steps presented below, in any order. The method may further include additional steps that will be recognized and understood by those of skill in the art. The method may include expanding a first occlusion device within the vessel, expanding a second occlusion device within the vessel, positioning a bypass flow tube to extend through the first and second occlusion devices, and positioning a drug delivery flow tube. The method may further include flowing blood through the bypass flow tube.

[0014] The method may further include flowing the drug through the drug delivery conduit.The method may further include aspirating through the drug delivery conduit.

[0015] The method may further include positioning the first occlusion device distally relative to the second occlusion device within the blood vessel.

[0016] The method may further include expanding the first occlusion device to occlude the blood vessel before expanding the second occlusion device to occlude the blood vessel.

[0017] The method may further include delivering a sealant effective to seal the intravascular lesion through the drug delivery conduit.

[0018] The method may further include delivering a drug to the ICAD lesion through a drug delivery conduit.

[0019] The method may further include providing an assembly including a first occlusion device, a second occlusion device, a bypass flow conduit, and a drug delivery flow conduit.

[0020] The method may further include delivering the assembly to an intracranial artery.

[0021] The step of expanding the first occlusion device may further include occluding the blood vessel by expanding the first occlusion device. The step of expanding the first occlusion device may further include inflating the first occlusion device. Alternatively, the step of expanding the first occlusion device may further include unsheathing the first occlusion device to allow the first occlusion device to self-expand.

[0022] The step of expanding the second occlusion device within the blood vessel may further include forming a cavity defined by the first occlusion device, the second occlusion device, and the blood vessel. The step of expanding the second occlusion device may further include inflating the second occlusion device. Alternatively, the step of expanding the second occlusion device may further include unsheathing the second occlusion device to allow the second occlusion device to self-expand.

[0023] The step of positioning the bypass flow conduit to extend through the first and second occlusion devices may further include positioning the bypass flow conduit to extend through the cavity. The bypass flow conduit may be positioned such that a first opening of the bypass flow conduit is disposed proximate the first occlusion element and a second opening of the bypass flow conduit is disposed proximate the second occlusion element, such that neither the first opening nor the second opening is disposed within the cavity.

[0024] The step of positioning the drug delivery flow tube may include positioning the drug delivery flow tube such that a proximal opening of the drug delivery flow tube is accessible outside the patient and a distal opening of the drug delivery flow tube is positioned within the cavity.

[0025] An exemplary intravascular treatment device can include a tube, a proximal expandable element, a distal expandable element, a delivery lumen, and a bypass lumen. The device can further include an inflation lumen.

[0026] The tube can have a proximal end, a distal end, and a length measured from the proximal end to the distal end. The length can be sized to extend from the femoral artery to the neurovasculature. The tube can include a portion or all of the delivery lumen such that a portion or all of the delivery lumen is an elongated channel extending through and integral with the tube. The distal opening of the delivery lumen can include a skive in the tube. The tube can include a portion or all of the bypass lumen such that a portion or all of the bypass lumen is an elongated channel extending through and integral with the tube. The proximal opening of the bypass lumen can include a skive in the tube.

[0027] The proximal expandable element can be disposed on the tube. The proximal expandable element can be expandable via an inflation lumen. Alternatively, the proximal expandable element can be self-expandable or otherwise expandable by means not requiring an inflation lumen, as will be recognized and understood by those skilled in the art.

[0028] The distal expandable element can be disposed distally on the tube relative to the proximal expandable element. The distal expandable element can be expandable via an inflation lumen. Alternatively, the proximal expandable element can be self-expandable or otherwise expandable by means not requiring an inflation lumen, as will be recognized and understood by those skilled in the art. If both the proximal and distal expandable elements are expandable, both expandable elements can be inflated by the same inflation lumen or two separate inflation lumens.

[0029] The delivery lumen can include a proximal opening and a distal opening. The proximal opening can be located near a proximal end of the tube. The distal opening can be located on the tube between the distal and proximal expandable elements. The delivery lumen can be coated with a coating effective to inhibit adhesion of the intravascular lesion sealant.

[0030] The bypass lumen can be separate from the delivery lumen such that the bypass lumen is not in fluid communication with the delivery lumen. The bypass lumen can include a proximal opening and a distal opening. The proximal opening can be disposed near the proximal expandable element and disposed proximally relative to the proximal expandable element. The distal opening can be disposed near the distal expandable element and disposed distally relative to the distal expandable element. The bypass lumen can provide a continuous flow path from its proximal opening to its distal opening.

[0031] If one or both of the proximal and distal expandable elements are inflatable (e.g., balloons), the inflation lumen can be configured to inflate one or both of the expandable elements. If both the proximal and distal expandable elements are inflatable, they can be inflated by the same inflation lumen. Alternatively, if both the proximal and distal expandable elements are inflatable, they can each be inflated by a different inflation lumen. [Brief description of the drawings]

[0032] The above and further aspects of the present invention are further explained by reference to the following description in conjunction with the accompanying drawings, in which like numerals in the various figures indicate like structural elements and features. The drawings are not necessarily to scale, emphasis instead being placed on illustrating the principles of the invention. The figures depict one or more implementations of the apparatus of the present invention, by way of example only and not by way of limitation. [Figure 1A] 1 is a diagram of a system for intravascular treatment at a treatment site during performance of a treatment method, according to an aspect of the present invention. [Figure 1B] 1 is a view of the proximal end of a system for intravascular treatment, according to an embodiment of the present invention. [Figure 2A] 1 is a diagram of an endovascular treatment system positioned across a lesion, according to an aspect of the present invention. [Figure 2B] 2C is a diagram of the endovascular treatment system of FIG. 2B positioned across a lesion, showing a cross-sectional view, in accordance with an embodiment of the present invention. [Figure 3A] 2C are cross-sectional views as shown in FIG. 2B, respectively, according to an embodiment of the present invention. [Figure 3B] 2C are cross-sectional views as shown in FIG. 2B, respectively, according to an embodiment of the present invention. [Figure 3C] 2C are cross-sectional views as shown in FIG. 2B, respectively, according to an embodiment of the present invention. [Figure 3D] 2C are cross-sectional views as shown in FIG. 2B, respectively, according to an embodiment of the present invention. [Figure 3E] 2C are cross-sectional views as shown in FIG. 2B, respectively, according to an embodiment of the present invention. [Figure 3F] 2C are cross-sectional views as shown in FIG. 2B, respectively, according to an embodiment of the present invention. [Figure 3G] 2C are cross-sectional views as shown in FIG. 2B, respectively, according to an embodiment of the present invention. [Figure 3H] 2C are cross-sectional views as shown in FIG. 2B, respectively, according to an embodiment of the present invention. [Figure 4A]1 is a diagram of another system for intravascular treatment at a treatment site during a treatment method according to an aspect of the present invention. [Figure 4B] FIG. 4B is a diagram of the system illustrated in FIG. 4A positioned across a lesion, showing a cross-sectional view, according to an embodiment of the present invention. [Figure 5A] 4C are cross-sectional views at the locations shown in FIG. 4B, respectively, according to an embodiment of the present invention. [Figure 5B] 4C are cross-sectional views at the locations shown in FIG. 4B, respectively, according to an embodiment of the present invention. [Figure 5C] 4C are cross-sectional views at the locations shown in FIG. 4B, respectively, according to an embodiment of the present invention. [Figure 5D] 4C are cross-sectional views at the locations shown in FIG. 4B, respectively, according to an embodiment of the present invention. [Figure 5E] 4C are cross-sectional views at the locations shown in FIG. 4B, respectively, according to an embodiment of the present invention. [Figure 5F] 4C are cross-sectional views at the locations shown in FIG. 4B, respectively, according to an embodiment of the present invention. [Figure 5G] 4C are cross-sectional views at the locations shown in FIG. 4B, respectively, according to an embodiment of the present invention. [Figure 6A] 1 is a diagram of another system for intravascular treatment at a treatment site during a treatment method according to an aspect of the present invention. [Figure 6B] 6B is a cross-sectional view of a system according to an embodiment of the present invention at the locations indicated in FIG. 6A. [Figure 6C] 6B is a cross-sectional view of a system according to an embodiment of the present invention at the locations indicated in FIG. 6A. [Figure 6D] 6B is a cross-sectional view of a system according to an embodiment of the present invention at the locations indicated in FIG. 6A. [Figure 7A] 6A-6D during steps of a treatment method according to an embodiment of the present invention. [Figure 7B] 6A-6D during steps of a treatment method according to an embodiment of the present invention. [Figure 7C]6A-6D during steps of a treatment method according to an embodiment of the present invention. [Figure 8A] FIG. 11 is a diagram of another system for intravascular procedures that functions according to the principles of the system illustrated in FIGS. 6A-6D and 7A-7C, in accordance with an embodiment of the present invention. [Figure 8B] FIG. 11 is a diagram of another system for intravascular procedures that functions according to the principles of the system illustrated in FIGS. 6A-6D and 7A-7C, in accordance with an embodiment of the present invention. [Figure 9A] 1 is a diagram of a procedure using an intravascular treatment system, such as one of the intravascular treatment systems illustrated herein, according to an embodiment of the present invention. [Figure 9B] 1 is a diagram of a procedure using an intravascular treatment system, such as one of the intravascular treatment systems illustrated herein, according to an embodiment of the present invention. [Figure 9C] 1 is a diagram of a procedure using an intravascular treatment system, such as one of the intravascular treatment systems illustrated herein, according to an embodiment of the present invention. [Figure 9D] 1 is a diagram of a procedure using an intravascular treatment system, such as one of the intravascular treatment systems illustrated herein, according to an embodiment of the present invention. [Figure 9E] 1 is a diagram of a procedure using an intravascular treatment system, such as one of the intravascular treatment systems illustrated herein, according to an embodiment of the present invention. [Figure 9F] 1 is a diagram of a procedure using an intravascular treatment system, such as one of the intravascular treatment systems illustrated herein, according to an embodiment of the present invention. [Figure 9G] 1 is a diagram of a procedure using an intravascular treatment system, such as one of the intravascular treatment systems illustrated herein, according to an embodiment of the present invention. [Figure 10] 1 is a flow chart outlining steps of an intravascular procedure according to an embodiment of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0033] The exemplary system presented herein may have the benefit of isolating a target area of ​​stenosis for diagnosis, drug administration, aspiration, and / or blood perfusion repair. The system may include two flexible balloons. Alternatively, the system may include a self-expandable and / or otherwise expandable occlusion device instead of or in addition to one or both of the two flexible balloons. The exemplary system presented herein may be used for a variety of procedures. In a procedure involving diagnosis, contrast may be retained in the target area, thereby improving image visibility and / or reducing the amount of contrast. In a procedure involving drug administration, the drug may be administered locally through a skive or other device opening located between the occlusion devices. The drug is administered to the area of ​​stenosis for a specific period of time, while reducing the risk of drug migration. The drug may be aspirated through the same opening through which the drug was administered. In a procedure involving aspiration, the same or another skive or device opening may be used to remove plaque debris that may occur during the procedure. During diagnosis, drug administration, and / or aspiration, blood perfusion can be restored by flowing blood through a skive or other device opening positioned proximally relative to the expandable occlusion device, and further through a tube extending across the target treatment area, and out a distal device opening positioned distally relative to the expandable occlusion device.

[0034] 1A and 1B show an exemplary system for endovascular treatment. FIG. 1A shows a distal portion of the system positioned at a target treatment area in a blood vessel BV. FIG. 1B shows a proximal portion of the system that may be manipulated by a user during a treatment procedure. The system may include a device 100 having a tubular body 110. The device may function as a catheter 100 having a length that may be measured from a proximal end 112 (FIG. 1B) of the tubular body 110 to a distal end 114 (FIG. 1A) of the tubular body. The length may be sized to extend from outside the patient into a blood vessel (e.g., through the femoral artery), through the vasculature, and into a vessel within a vein (e.g., within the neurovasculature). The device 100 may include a proximal expandable occlusion element 102 disposed on the tubular body 110. The device 100 may include a distal expandable occlusion element 104 disposed on the tubular body 110. The distal expandable occlusion element 104 may be disposed in a distal direction 14 relative to the proximal expandable occlusion element 102. The device may include a treatment lumen 130 having a proximal opening 132 near the proximal end 112 of the tubular body 110 and a distal opening 134 disposed near the distal end 114 of the tubular body 110. The distal opening 134 of the treatment lumen 130 may be disposed between the occlusion elements 102 and 104. The device 100 may include an irrigation lumen 140 having a proximal opening 142 disposed in a proximal direction 12 relative to the occlusion elements 102, 104 and a distal opening 144 disposed in a distal direction 14 relative to the occlusion elements 102, 104.

[0035] The device 100 may be delivered to the treatment site by means as will be recognized and understood by those skilled in the art. The device 100 may be delivered through a guide catheter GC as shown in FIGS. 1A and 1B, or may be delivered without a guide catheter GC. The device 100 may be guided over a guidewire GW. The device 100 may be guided over an elongated member that extends through the lumen of the device and easily positioned at the treatment site in a manner similar to known methods for delivering a catheter over an elongated member. The elongated member need not have a solid core. Such an elongated member shall be generally referred to herein as a "guidewire". Alternatively, the device 100 may not necessarily be delivered over a guidewire.

[0036] The proximal expandable occlusion element 102 may be expandable from a collapsed shape sized to pass through the guide catheter GC to an expanded shape sized to occlude the blood vessel BV. The distal expandable occlusion element 102 may be expandable from a collapsed shape sized to pass through the guide catheter GC to an expanded shape sized to occlude the blood vessel BV. One or both of the proximal occlusion element 102 and the distal occlusion element 104 may comprise a fluid-impermeable material. Preferably, both occlusion elements 102, 104 comprise a fluid-impermeable material and are configured to block blood flow through the blood vessel BV when expanded, making the perfusion lumen 140 the only path for blood to flow across the treatment site. One of the proximal occlusion element 102 and the distal occlusion element 104 may comprise a balloon that may be expanded via an inflation lumen. Additionally or alternatively, one of the proximal occlusion element 102 and the distal occlusion element 104 may comprise a self-expandable element. The proximal occlusion element 102 and the distal occlusion element 104 may each be expandable to be in apposition with the blood vessel BV, but effective to block the flow of blood through the blood vessel BV outside the confines of the device 100. In other words, the proximal occlusion element 102 and the distal occlusion element 104 may be expanded to define an isolated treatment region within the blood vessel BV extending between the two occlusion elements 102, 104.

[0037] The treatment lumen 130 may be configured to allow fluid to be delivered between a proximal opening 132 near the proximal end 112 of the elongate tubular body 110 and a distal opening 134 between the occlusion elements 102, 104. Additionally or alternatively, the treatment lumen 130 may be configured to allow a mechanical treatment device to extend from the proximal opening 132 to the distal opening 134. During treatment, the proximal opening 132 may be accessible to a user (e.g., a physician) to apply suction, inject fluid, and / or operate the mechanical treatment device, while the distal opening 134 is positioned at the treatment site (e.g., near a lesion P in the blood vessel BV). Suction, injection of fluid, and / or operation of the mechanical treatment device via the treatment lumen 130 may be performed while the proximal and distal occlusion elements 102, 104 are expanded into apposition with the blood vessel BV. The treatment lumen 130 may be a delivery lumen sized for delivery of a drug suitable for treating the intravascular lesion P. The treatment lumen 130 may be further coated with a coating effective to inhibit adhesion of a sealant effective to seal the intravascular lesion P. Additionally or alternatively, the treatment lumen 130 may be sized to aspirate blood from the blood vessel BV. The treatment lumen 130 may further have sufficient structural integrity to withstand collapse due to suction forces generated during aspirating. Additionally or alternatively, the treatment lumen 130 may be sized to accommodate a clot retriever, a mechanical treatment device configured to disrupt plaque, and / or a mechanical treatment device configured to capture plaque fragments.

[0038] The perfusion lumen 140 may function as a bypass lumen configured to allow blood to flow through the proximal occlusion element 102 and the distal occlusion element 104. During treatment, blood may flow between the proximal opening 142 of the perfusion lumen 140 and the distal opening 144 of the perfusion lumen 140 to at least partially allow perfusion of blood. The perfusion lumen 140 may further function as a guide lumen configured to allow passage of a guidewire GW from the proximal end 112 of the tubular body 110 to the distal end 114 of the tubular body 110. So configured, the perfusion lumen 140 of the device 100 may slide over the guidewire GW during delivery to the treatment site. Alternatively, the device 100 may include a guidewire lumen separate from the perfusion lumen 140, in which case the perfusion lumen 140 does not necessarily extend proximally beyond the proximal opening 142.

[0039] The device 100 may further include radiopaque material to aid in positioning the device 100 during a procedure. As shown in FIG. 1A, the device 100 may include a proximal marker band 106 disposed on the tubular body 110 proximal to the proximal occlusion element 102 and a distal marker band 124 disposed on the tubular body 110 proximal to the distal occlusion element 104. The radiopaque material may be disposed or otherwise incorporated as will be recognized and understood by those skilled in the art.

[0040] 2A and 2B are diagrams of an endovascular treatment system in a folded configuration positioned across a lesion P. FIGS. 3A-3H are cross-sectional views of the system shown in FIG. 2B. With reference collectively to FIGS. 2A, 2B, and 3A-3H, the system may include a treatment device 100a, a guide catheter GC, and a guidewire GW, as shown and described in connection with FIGS. 1A and 1B. The treatment device 100a illustrated in FIGS. 2A, 2B, and 3A-3H is shown as including a proximal expandable element 102a including a balloon and a distal expandable element 104a including a balloon. If not otherwise stated, the treatment device 100a may include an elongate body 110, a treatment lumen 130, and an irrigation lumen 140, as shown and / or described in connection with FIGS. 1A and 1B.

[0041] FIG. 2A shows the device 100a covered by a guide catheter GC as a sheath while being positioned across the lesion P. Alternatively, the device 100a may be configured to be delivered across the lesion P in an unsheathed state. In some procedures, the device 100a may be delivered across the lesion P in an unsheathed state. Whether delivery is performed in a sheathed or unsheathed state, the device 100a may be positioned in an unsheathed state as shown in FIG. 2B. The device 100a may extend along a longitudinal axis 10 as shown in FIG. 2B. The cross-sectional views shown in FIGS. 3A-3H are views looking proximally on the longitudinal axis 10.

[0042] FIG. 3A shows a cross-section of the device 100a as shown in FIG. 2B. The elongated tubular body 110 may include at least a portion of the treatment lumen 130. The elongated tubular body 110 may include at least a portion of the perfusion lumen 140. The perfusion lumen 140 may further provide a passage for the guidewire GW as shown. Thus, the perfusion lumen 140 may include a third opening 150 near the proximal end 112 (see FIG. 1B) of the device 100a, allowing the guidewire GW to enter the device 100a. Alternatively, the device 100a may include an additional lumen to allow passage of the guidewire GW, in which case the perfusion lumen 140 need not extend in the proximal direction 12 relative to the proximal opening 142. The device 100a may include one or more inflation lumens 120 extending the majority of the length of the tubular body 110. 3A-3H, device 100a can include a single inflation lumen 120 in communication with both the balloon of proximal expandable element 102a and the balloon of distal expandable element 104a. Alternatively, device 100a can include two separate inflation lumens, one for the balloon of proximal expandable element 102a and one for the balloon of distal expandable element 104a. Alternatively, only one of proximal expandable element 102a and distal expandable element 104a can include a balloon, and device 100a can include a single inflation lumen for inflating the balloon.

[0043] 3B shows a cross section of device 100a as shown in FIG 2B. Tubular body 110 can be cut into perfusion lumen 140 to form a proximal opening 142 of perfusion lumen 140. Proximal opening 142 of perfusion lumen 140 can be a skive in the sidewall of tubular body 110.

[0044] 3C shows a cross-section of device 100a as shown in FIG. 2B. The balloon of proximal expandable element 102a is shown surrounding tubular body 110. Tubular body 110 may have an opening 122 below the balloon of proximal expandable element 102a to allow the balloon to be inflated via inflation lumen 120.

[0045] Figure 3D shows a cross-section of the device 100a as shown in Figure 2B. The inflation lumen 120 can extend in the distal direction 14 relative to the balloon of the proximal expandable element 102a.

[0046] 3E shows a cross section of device 100a as shown in FIG 2B. Tubular body 110 can include an opening 134 to treatment lumen 130. As shown, during treatment, opening 134 to treatment lumen 130 can be positioned at lesion P. Opening 134 to treatment lumen 130 can include a skive in tubular body 110.

[0047] Figure 3F shows a cross-section of device 100a as shown in Figure 2B. As shown, treatment lumen 130 need not extend beyond opening 134 disposed between occlusion element 102a and occlusion element 104a.

[0048] Figure 3G shows a cross section of device 100a as shown in Figure 2B. Tubular body 110 can include an opening 124 to inflation lumen 120. Opening 124 to inflation lumen 120 can be disposed below the balloon of distal occlusion element 104a. The balloon of distal occlusion element 104a can be inflated via inflation lumen 120 through opening 124 below the balloon.

[0049] 3H shows a cross-section of device 100a as shown in FIG 2B. Perfusion lumen 140 can extend in distal direction 14 relative to distal occlusion element 104a. Inflation lumen 120 need not extend in distal direction 14 relative to distal occlusion element 104a.

[0050] 3A-3H, perfusion lumen 140 can provide a continuous flow path from its proximal opening 142, through first expandable occlusion element 102a, through second expandable occlusion element 104a, to a distal opening 144 of perfusion lumen 140. Perfusion lumen 140 can be sized to facilitate perfusion of blood.

[0051] 4A and 4B are diagrams of another endovascular treatment system in a folded configuration positioned across a lesion P. FIGS. 5A-5G are diagrams of the cross-sections shown in FIG. 4B of the system, respectively. With reference collectively to FIGS. 4A, 4B, and 5A-5G, the system may include a treatment device 100b, a guide catheter GC, and a guidewire GW, as shown and described in connection with FIGS. 1A and 1B. The treatment device 100b illustrated in FIGS. 4A, 4B, and 5A-5G is shown as including a proximal expandable element 102a including a balloon and a distal expandable element 104a including a balloon. If not otherwise stated, the treatment device 100b may include an elongate body 110, a treatment lumen 130, and an irrigation lumen 140, as shown and described in connection with FIGS. 1A and 1B. The device 100b shown in Figures 4A, 4B, and 5A-5G may have similar functionality to the device 100a shown in Figures 2A, 2B, and 3A-3H. The device 100b shown in Figures 4A, 4B, and 5A-5G differs from the device 100a shown in Figures 2A, 2B, and 3A-3H primarily in the shape and location of the treatment lumen 130, the perfusion lumen 140, and the inflation lumen 120. The device 100b shown in Figures 4A, 4B, and 5A-5G may include radiopaque markers 106, 108.

[0052] FIG. 4A shows device 100b covered by guide catheter GC as a sheath while positioned across lesion P. Alternatively, device 100b may be configured to be delivered across lesion P in an unsheathed state. In some procedures, device 100b may be delivered across lesion P in an unsheathed state. Whether delivery is performed in a sheathed or unsheathed state, device 100b may be deployed in an unsheathed state as shown in FIG. 4B. Device 100b may extend along a longitudinal axis 10. The cross-sectional views shown in FIGS. 5A-5G are views looking proximally on longitudinal axis 10.

[0053] FIG. 5A shows a cross-section of the device 100b as shown in FIG. 4B. The elongated tubular body 110 may include at least a portion of the treatment lumen 130. The elongated tubular body 110 may include at least a portion of the perfusion lumen 140. The perfusion lumen 140 may further provide a passage for the guidewire GW as shown. Thus, the perfusion lumen 140 may include a third opening 150 near the proximal end 112 (see FIG. 1B) of the device 100b, allowing the guidewire GW to enter the device 100b. Alternatively, the device 100b may include an additional lumen to allow passage of the guidewire GW, in which case the perfusion lumen 140 need not extend in the proximal direction 12 relative to the proximal opening 142. The device 100b may include one or more inflation lumens 120 extending the majority of the length of the tubular body 110. 5A-5G, device 100b can include a single inflation lumen 120 in communication with both the balloon of proximal expandable element 102a and the balloon of distal expandable element 104a. Alternatively, device 100b can include two separate inflation lumens, one for the balloon of proximal expandable element 102a and one for the balloon of distal expandable element 104a. Alternatively, only one of proximal expandable element 102a and distal expandable element 104a can include a balloon, and device 100a can include a single inflation lumen for inflating the balloon.

[0054] Figure 5B shows a cross section of device 100b as shown in Figure 4B. Tubular body 110 can be cut into perfusion lumen 140 to form a proximal opening 142 of perfusion lumen 140. Proximal opening 142 of perfusion lumen 140 can be a skive in the sidewall of tubular body 110.

[0055] 5C shows a cross section of device 100b as shown in FIG. 4B. The balloon of proximal expandable element 102a is shown surrounding tubular body 110. Tubular body 110 may have an opening 122 below the balloon of proximal expandable element 102a to allow the balloon to be inflated via inflation lumen 120.

[0056] Figure 5D shows a cross section of the device 100b as shown in Figure 4B. The inflation lumen 120 can extend in the distal direction 14 relative to the balloon of the proximal expandable element 102a.

[0057] FIG. 5E illustrates a cross-section of device 100b as shown in FIG. 4B. Tubular body 110 may include an opening 134 to treatment lumen 130. As illustrated, during treatment, opening 134 to treatment lumen 130 may be located at lesion P. Opening 134 to treatment lumen 130 may include a skive in tubular body 110. As illustrated, perfusion lumen 140 may be substantially circular in cross-section, however treatment lumen 130 may have a curved shape disposed around a portion of the periphery of perfusion lumen 140. So configured, tubular body 110 may have a smaller circumference in a distal direction 14 relative to opening 134 to treatment lumen 130 as compared to the circumference of tubular body 110 in a proximal direction relative to opening 134.

[0058] FIG. 5F illustrates a cross-section of device 100b as shown in FIG. 4B. Tubular body 110 may include an opening 124 to inflation lumen 120. Opening 124 to inflation lumen 120 may be disposed below the balloon of distal occlusion element 104a. The balloon of distal occlusion element 104a may be inflated through opening 124 below the balloon and via inflation lumen 120. As illustrated, inflation lumen 120 may have a curved shape disposed around a portion of the circumference of perfusion lumen 140. So configured, tubular body 110 may have a smaller circumference in the distal direction 14 to opening 124 to inflation lumen 120 compared to the circumference of tubular body 110 in the proximal direction to opening 124.

[0059] 5G shows a cross section of device 100b as shown in FIG 4B. Perfusion lumen 140 can extend in distal direction 14 relative to distal occlusion element 104a. Inflation lumen 120 need not extend in distal direction 14 relative to distal occlusion element 104a.

[0060] 5A-5G, perfusion lumen 140 can provide a continuous flow path from its proximal opening 142, through first expandable occlusion element 102a, through second expandable occlusion element 104a, to a distal opening 144 of perfusion lumen 140. Perfusion lumen 140 can be sized to facilitate perfusion of blood.

[0061] FIG. 6A is a diagram of another endovascular treatment system in a folded configuration positioned across a lesion P. FIGS. 6B-6D are diagrams of the cross-sections shown in FIG. 6A of the system, respectively. Referring collectively to FIGS. 6A-6D, the system may include a treatment device 100c, a guide catheter GC, and a guidewire GW, as shown and described in connection with FIGS. 1A and 1B. The treatment device 100c illustrated in FIGS. 6A-6D is shown as including a proximal expandable element 102b that is self-expandable when unsheathed, and a distal expandable element 104b that is self-expandable when unsheathed. The device 100c may be delivered across the lesion P while covered by the guide catheter GC as a sheath, or may be covered by a sheath as will be recognized and understood by those skilled in the art. The treatment device 100c may include an elongate body 110, a treatment lumen 130, and an irrigation lumen 140, as shown and described in connection with FIGS. 1A and 1B. The device 100c shown in FIGS. 6A-6D may include radiopaque markers 106, 108.

[0062] FIG. 6B shows a cross section of the device 100c as shown in FIG. 6A. The elongated tubular body 110 may include at least a portion of the treatment lumen 130. The elongated tubular body 110 may include at least a portion of the perfusion lumen 140. The perfusion lumen 140 may further provide a passage for the guidewire GW as shown. Thus, the perfusion lumen 140 may include a third opening 150 near the proximal end 112 (see FIG. 1B) of the device 100c, allowing the guidewire GW to enter the device 100c. Alternatively, the device 100c may include an additional lumen to allow passage of the guidewire GW, in which case the perfusion lumen 140 need not extend in the proximal direction 12 relative to the proximal opening 142. The device 100c need not include an inflation lumen.

[0063] 6C shows a cross section of device 100c as shown in FIG 6A. Tubular body 110 can be cut into perfusion lumen 140 to form a proximal opening 142 of perfusion lumen 140. Proximal opening 142 of perfusion lumen 140 can be a skive in the sidewall of tubular body 110.

[0064] Figure 6D shows a cross section of device 100c as shown in Figure 6A. Tubular body 110 can be cut into treatment lumen 130 to form an opening 134 to treatment lumen 130.

[0065] 7A-7C are diagrams of the system illustrated in FIGS. 6A-6D illustrating the unsheathing of expandable occlusion elements 102b, 104b.

[0066] 7A shows the guide catheter GC moving in the proximal direction 12 while the device 100c remains in position across the lesion P. The distal occlusion element 104b may expand and appose the wall of the blood vessel BV when its sheath is removed. The distal occlusion element 104b may include a shape memory material that may move toward a predetermined shape upon heating from contact with blood. Additionally or alternatively, the distal occlusion element 104b may include a spring-loaded body that is held in a compressed state by the guide catheter GC or other sheath and that opens when the sheath is removed.

[0067] 7B shows the guide catheter GC moving in the proximal direction 12 while the device 100c remains in position across the lesion P. The distal occlusion element 104b can be fully expanded and circumferentially apposed to the wall of the blood vessel BV before the proximal expandable element 102b is unsheathed. The proximal occlusion element 102b can expand and appose to the wall of the blood vessel BV once it is unsheathed. The proximal occlusion element 102b can include a shape memory material that can move toward a predetermined shape upon heating from contact with blood. Additionally or alternatively, the proximal occlusion element 102b can include a spring-loaded body that is held in a compressed state by the guide catheter GC or other sheath and released when the sheath is unsheathed.

[0068] 7C shows proximal occlusion element 102b and distal occlusion element 104b in a fully expanded state, in which step cavity C is isolated for performing the procedure.

[0069] Figures 8A and 8B are diagrams of another system for endovascular treatment that functions according to the principles of the system illustrated in Figures 6A-6D and 7A-7B. The system can include a device 100d having a tube 110 having two self-expandable elements 102c, 104c thereon. The device 100d can further include a treatment lumen 130 and a perfusion lumen 140, such as those described in connection with Figures 6A-6D and 7A-7B.

[0070] FIG. 8A shows occlusion elements 102c, 104c that are adapted to be expanded to occlude blood vessel BV and isolate lesion P. FIG.

[0071] 8B shows the component parts of the expandable occlusion element 102c, 104c. The expandable occlusion element 102c, 104c can include a framework 146 and a coating or cover 148. The coating or cover 148 can be fluid impermeable. The coating or cover 148 can be flexible, or if so, folded, when the expandable occlusion element 102c, 104c is in a collapsed configuration. The framework 146 can provide a force to appose the occlusion element 102c, 104c to the wall of the blood vessel BV. The framework 146 can include a shape memory material that expands due to heat upon contact with blood. Additionally or alternatively, the framework 146 can include a spring-loaded material that is held in a compressed state when sheathed and expands when unsheathed. When the occlusion elements 102c, 104c are expanded, the occlusion elements 102c, 104c may assume a parabolic shape with an expanded open end 154 apposed to the wall of the blood vessel and an apex connected to the tubular body 110. The device 100c may include a connection 152, such as a weld, adhesive, crimp collar, or other connection as will be recognized and understood by those skilled in the art, that connects the apex of the parabolic shape of the occlusion elements 102c, 104c to the tubular body 110. The expanded open end 154 may be disposed in a distal direction 14 relative to the apex. In other words, the parabolic shape of the occlusion elements 102c, 104c may expand toward the distal end 114 of the tubular body 110.

[0072] 9A-9G are diagrams of a treatment process using an endovascular treatment system having a treatment device 100 such as that shown and described in connection with Figures 1A and 1B. The treatment device 100 may have a structure and functionality similar to any one of the treatment devices 100a, 100b, 100c, 100d shown and described in connection with Figures 2A-2B, 3A-3G, 4A-4B, 5A-5G, 6A-6D, 7A-7C, and 8A-8B, or variations or alternatives thereof as will be recognized and understood by those skilled in the art.

[0073] FIG. 9A shows the device 100 positioned across the lesion P with the occlusion elements 102, 104 expanded and isolating the lesion P. The lesion P may be located within an intracranial artery. The procedure may include delivering the device 100 to the intracranial artery. The occlusion elements 102, 104 and the wall of the blood vessel BV may define a cavity C that contains the lesion P. The cavity C may be located within the intracranial artery. The occlusion elements 102, 104 may include balloons, such as the occlusion elements 102a, 104a illustrated in FIGS. 2A-2B, 3A-3G, 4A-4B, and 5A-5G. Additionally or alternatively, the occlusion elements 102, 104 may include self-expanding elements, such as the occlusion elements 102b, 104b, 102c, 104c illustrated in FIGS. 6A-6D, 7A-7C, and 8A-8B. Otherwise, the occlusion elements may include balloons or self-expanding elements, as will be recognized and understood by those skilled in the art. The procedure may include inflating one or both of the occlusion elements 102, 104. Additionally or alternatively, the procedure may include unsheathing one or both of the occlusion elements 102, 104 and allowing the occlusion elements to self-expand. The distal occlusion element 104 may be expanded before the proximal occlusion element 102.

[0074] The perfusion lumen 140 may be positioned to function as a bypass flow conduit extending through the proximal occlusion element 102, the cavity C, and the distal occlusion element 104. The proximal opening 142 of the perfusion lumen 140 may be proximal to the proximal occlusion element 102 and disposed in the proximal direction 12 relative to the proximal occlusion element 102. The distal opening 144 of the perfusion lumen 140 may be proximal to the distal occlusion element 104 and disposed in the distal direction 14 relative to the distal occlusion element 104. The distal and proximal openings 144, 142 of the perfusion lumen 140 may be disposed on either side of the lesion P such that when the occlusion elements 102, 104 are expanded to define cavity C, the proximal opening 142 of the perfusion lumen 140 is disposed in a proximal direction 12 relative to cavity C and the distal opening 144 of the perfusion lumen 140 is disposed in a distal direction 14 relative to cavity C. The proximal and distal openings 142, 144 of the perfusion lumen 140 may be disposed such that neither opening 142, 144 is within cavity C. The perfusion lumen 140 may be isolated from cavity C. Blood can enter the perfusion lumen 140 at the proximal opening 142 of the perfusion lumen 140 (as indicated by the arrow at the proximal opening 142) and exit the perfusion lumen 140 at the distal opening 144 of the perfusion lumen 140 (as indicated by the arrow at the distal opening 144) to restore perfusion to the blood vessel BV. In procedures where blood flows in the opposite direction, blood can enter the perfusion lumen 140 at the distal opening 144 and exit the perfusion lumen 140 at the proximal opening 142. Blood can flow through the perfusion lumen 140 without interacting with the fluid in the cavity C. The distal opening 134 of the treatment lumen 130 can be disposed within the cavity C. The proximal opening 132 of the treatment lumen 130 can be accessible outside the patient (see FIG. 1B).

[0075] 9B shows fluid exiting the treatment lumen 130 through the distal opening 134 of the treatment lumen 130 (as indicated by the arrow at the distal opening 134). The treatment may include flowing a fluid through the treatment lumen 130. The fluid may include a drug, such as a sealant, to seal the intravascular lesion. Additionally or alternatively, the fluid may include a drug effective to disrupt plaque at the lesion P. The treatment may include delivering a drug to the intracranial arterial disease (ICAD) lesion P. Blood may continue to flow through the perfusion lumen 140 while the fluid is delivered through the treatment lumen 130.

[0076] 9C shows plaque fragment F breaking off from lesion P and floating within the isolation area between occlusion element 102 and occlusion element 104. Sealant 136 is shown coating lesion P. Blood can continue to flow through perfusion lumen 140.

[0077] 9D shows fragment F (indicated by an arrow at distal opening 134) being aspirated into treatment lumen 130 via distal opening 134 of treatment lumen 130. Treatment may include aspirating through treatment lumen 130. During aspiration, blood may continue to flow through perfusion lumen 140.

[0078] 9E shows blood continuing to flow through perfusion lumen 140 until treatment of the lesion is complete. The continued flow of blood through perfusion lumen 140 can facilitate longer treatment of isolated lesions compared to treatments lacking blood perfusion.

[0079] 9F illustrates device 100 being collapsed to remove device 100 from blood vessel BV. As shown, an occlusion element including a balloon can be deflated. Additionally or alternatively, an occlusion element including a self-expandable element can be collapsed into a guide catheter GC or other sheath.

[0080] FIG. 9G shows the system being removed from the treatment site.

[0081] FIG. 10 is a flow diagram of a method 200 of an intravascular procedure. In step 202, an assembly can be provided that can include two expandable elements, a bypass flow tube, and a drug delivery flow tube and / or an aspiration flow tube. The two expandable elements can be similar to the expandable elements 102, 102a-102c, 104, 104a-104c shown and described herein, variations thereof, or alternatives thereof as will be recognized and understood by those of skill in the art. The bypass flow tube can be similar to the perfusion lumen 140 of the devices 100, 100a-100c shown and described herein, variations thereof, or alternatives thereof as will be recognized and understood by those of skill in the art. The drug delivery flow tube and / or an aspiration flow tube can be similar to the treatment lumen 130 of the devices 100, 100a-100c shown and described herein, variations thereof, or alternatives thereof as will be recognized and understood by those of skill in the art.

[0082] In step 204, the assembly may be delivered to an intracranial blood vessel. The assembly may be delivered through a guide catheter GC, or may otherwise be delivered in a manner recognized and understood by those skilled in the art.

[0083] At step 206, an occlusion element may be expanded within the blood vessel on either side of the treatment area. The occlusion element may be expanded as shown and described herein, or using other means as will be recognized and understood by those of skill in the art.

[0084] At step 208, a bypass flow tube may be positioned to extend through the occlusion element and the treatment area such that two openings of the bypass flow tube are positioned, one on each side of the treatment area. The ends of the bypass flow tube may be positioned in a manner similar to the manner of positioning the ends 142, 144 of the perfusion lumen 140 of any of the devices 100, 100a-100c shown and described herein, variations thereof, or alternatives thereof as will be recognized and understood by those of skill in the art.

[0085] In step 210, the drug delivery conduit and / or aspiration conduit may be positioned such that there is a distal opening at the treatment area and a proximal opening accessible outside of the patient. The ends of the drug delivery conduit and / or aspiration conduit may be positioned similarly to the placement of the ends 132, 134 of the treatment lumen 130 of any of the devices 100, 100a-100c shown and described herein, variations thereof, or alternatives as will be recognized and understood by those of skill in the art.

[0086] In step 212, blood can be allowed to flow through the bypass flow tube. Generally speaking, blood can flow through the bypass flow tube whenever both of the two openings are within the blood vessel. When the blood vessel BV is blocked between the two openings of the bypass flow tube (e.g., due to a clot, plaque, and / or an expanded expandable element), blood can flow through the bypass flow tube to provide blood perfusion to the blood vessel across the occluded area.

[0087] In step 214, a drug can be flowed through the drug delivery / aspiration conduits. The drug can include a sealant for sealing intravascular lesions. Additionally or alternatively, the drug can include an agent for disrupting plaque.

[0088] In step 216, the treatment site may be aspirated via the drug delivery / aspiration conduit.

[0089] The descriptions contained herein are examples of embodiments of the present invention and are not intended to limit the scope of the present invention in any way. As described herein, the present invention contemplates many variations and modifications of the intravascular treatment devices and systems, including alternative materials, alternative geometries of component parts, alternative methods of using the devices for treatment, etc. Modifications and variations that are obvious to those skilled in the art from the teachings herein are contemplated to be within the scope of the following claims.

[0090] [Embodiment] (1) A catheter for performing intravascular treatment, comprising: an elongated tubular body including a proximal end, a distal end, and a length therebetween; a proximal expandable occlusion element disposed on the tubular body, the proximal expandable occlusion element being expandable from a collapsed configuration sized to pass through a guide catheter to an expanded configuration sized to occlude a blood vessel; a distal expandable occlusion element disposed on the tubular body distally relative to the proximal expandable occlusion element, the distal expandable occlusion element being expandable from a collapsed configuration sized to pass through a guide catheter to an expanded configuration sized to occlude a blood vessel; a first fluid lumen having a proximal opening adjacent the proximal end of the elongate tubular body and a distal opening disposed distally relative to the proximal expandable occlusion element and proximally relative to the distal expandable occlusion element; a second fluid lumen separated from the first fluid lumen, the second fluid lumen having a proximal opening adjacent to the proximal expandable occlusion element and disposed in the proximal direction relative to the proximal expandable occlusion element, and a distal opening adjacent to the distal expandable occlusion element and disposed in the distal direction relative to the distal expandable occlusion element; A catheter comprising: (2) one or more inflation lumens extending along a majority of the length of the tubular body and in communication with the proximal and distal expandable occlusion elements; the proximal expandable occlusion element and the distal expandable occlusion element are each expandable from the collapsed configuration to the expanded configuration via the one or more inflation lumens. 2. A catheter as described in embodiment 1. (3) the elongated tubular body includes at least a portion of the first fluid lumen; the distal opening of the first fluid lumen includes a skive within the elongate tubular body. 2. A catheter as described in embodiment 1. (4) the elongated tubular body includes at least a portion of the second fluid lumen; the proximal opening of the second fluid lumen includes a skive within the elongate tubular body. 2. A catheter as described in embodiment 1. (5) The catheter of embodiment 1, wherein the second fluid lumen provides a continuous flow path from its proximal opening to its distal opening.

[0091] (6) the first fluid lumen is sized for delivery of a drug suitable for treating an intravascular lesion; the first fluid lumen is coated with a coating effective to inhibit adhesion of a sealant effective to seal the intravascular lesion. 2. A catheter as described in embodiment 1. (7) A method for delivering a drug into an isolated blood vessel, comprising: expanding a first occlusion device within the blood vessel to occlude the blood vessel; expanding a second occlusion device within the blood vessel to form a cavity defined by the first occlusion device, the second occlusion device, and the blood vessel; positioning a bypass flow conduit to extend through the first occlusion device, through the cavity, and through the second occlusion device such that a first opening of the bypass flow conduit is disposed adjacent to the first occlusion element and a second opening of the bypass flow conduit is disposed adjacent to the second occlusion element, and such that neither the first opening nor the second opening is disposed within the cavity; positioning a drug delivery conduit such that a proximal opening of the drug delivery conduit is accessible outside the patient and a distal opening of the drug delivery conduit is disposed within the cavity; The method includes: (8) flowing blood through the bypass flow tube; and flowing a drug through the drug delivery flow tube; 8. The method of embodiment 7, further comprising: 9. The method of claim 8, further comprising aspirating through the drug delivery tube. (10) The method of embodiment 7, wherein expanding the first occlusion device further comprises inflating the first occlusion device.

[0092] (11) The method of embodiment 10, wherein expanding the second occlusion device further comprises inflating the second occlusion device. (12) positioning the first occlusion device in the blood vessel in the distal direction relative to the second occlusion device; expanding the first occlusion device to occlude the blood vessel before expanding the second occlusion device to occlude the blood vessel; 8. The method of embodiment 7, further comprising: (13) The method of embodiment 7, further comprising delivering a sealant through the drug delivery conduit effective to seal the intravascular lesion. (14) The method of embodiment 7, further comprising delivering a drug to an intracranial arterial disease lesion through the drug delivery flow conduit. (15) providing an assembly including the first occlusion device, the second occlusion device, the bypass flow conduit, and the drug delivery flow conduit; delivering the assembly to an intracranial artery; 8. The method of embodiment 7, further comprising:

[0093] (16) An intravascular treatment device, comprising: a tube having a proximal end, a distal end, and a length therebetween, the length being sized to extend from the femoral artery to a neurovasculature; a proximal expandable element disposed on the tube; a distal expandable element disposed on the tube distally relative to the proximal expandable element; a delivery lumen having a proximal opening adjacent the proximal end of the tube and a distal opening disposed on the tube between the distal and proximal expandable elements; a bypass lumen separate from the delivery lumen, the bypass lumen comprising a proximal opening adjacent to and disposed in the proximal direction relative to the proximal expandable element, and a distal opening adjacent to and positioned in the distal direction relative to the distal expandable element; An intravascular treatment device comprising: (17) Further comprising an inflation lumen; at least one of the proximal expandable element and the distal expandable element is a balloon; At least one of the proximal expandable element and the distal expandable element is expandable via the inflation lumen. 17. The apparatus of embodiment 16. (18) The tube includes at least a portion of the delivery lumen, the distal opening of the delivery lumen includes a skive in the tube. 17. The apparatus of embodiment 16. (19) The tube includes at least a portion of the bypass lumen, the proximal opening of the bypass lumen includes a skive in the tube. 17. The apparatus of embodiment 16. (20) The device of embodiment 16, wherein the bypass lumen provides a continuous flow path from its proximal opening to its distal opening.

[0094] (21) The device of embodiment 16, wherein the delivery lumen is coated with a coating effective to inhibit adhesion of an intravascular lesion sealant.

Claims

1. A catheter for performing intravascular treatment, comprising: an elongated tubular body including a proximal end, a distal end, and a length therebetween; a proximal expandable occlusion element disposed on the tubular body, the proximal expandable occlusion element being expandable from a collapsed configuration sized to pass through a guide catheter to an expanded configuration sized to occlude a blood vessel; a distal expandable occlusion element disposed on the tubular body distally relative to the proximal expandable occlusion element, the distal expandable occlusion element being expandable from a collapsed configuration sized to pass through a guide catheter to an expanded configuration sized to occlude a blood vessel; a first fluid lumen having a proximal opening adjacent the proximal end of the elongate tubular body and a distal opening disposed distally relative to the proximal expandable occlusion element and proximally relative to the distal expandable occlusion element; a second fluid lumen separated from the first fluid lumen, the second fluid lumen including a proximal opening adjacent to the proximal expandable occlusion element and disposed in the proximal direction relative to the proximal expandable occlusion element, and a distal opening adjacent to the distal expandable occlusion element and disposed in the distal direction relative to the distal expandable occlusion element; Equipped with The proximal expandable occlusion element includes a spring-loaded body that is held in a compressed state by the guide catheter while contained within the guide catheter and expands upon removal from the guide catheter.

2. the elongated tubular body includes at least a portion of the first fluid lumen; the distal opening of the first fluid lumen includes a skive within the elongate tubular body. The catheter of claim 1.

3. the elongate tubular body includes at least a portion of the second fluid lumen; the proximal opening of the second fluid lumen includes a skive within the elongate tubular body. The catheter of claim 1.

4. The catheter of claim 1 , wherein the second fluid lumen provides a continuous flow path from its proximal opening to its distal opening.

5. the first fluid lumen is sized for delivery of a drug suitable for treating an intravascular lesion; the first fluid lumen being coated with a coating effective to inhibit adhesion of a sealant effective to seal the intravascular lesion; The catheter of claim 1.

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