Preparation-free balloon guide catheter

Abstract

To provide a balloon guide catheter.SOLUTION: A system 100 has a balloon guide catheter 110 for use in mechanical thrombectomy procedures which requires very little preparation to inflate a balloon 113 compared to most contemporary designs. The balloon guide catheter can have an elongated tubular member and a proximal luer 118. The elongated tubular member of the catheter can have two internal lumens. A first inner hollow lumen 114 can have a large opening for the aspiration and the advancement of auxiliary devices, and a second inflation lumen can provide a fluidic passageway to inflate the balloon. The proximal luer can have a luer lumen, an inflation port, and a mandrel hub. A removable mandrel 216 can extend distally from the mandrel hub to occupy the full length and volume of the inflation lumen of the tubular member.SELECTED DRAWING: Figure 1

Description

[Technical field]

[0001] The present invention relates generally to devices and methods used in removing acute occlusions from blood vessels during endovascular medical procedures, and more particularly to balloon guide catheters used to occlude portions of target blood vessels during such procedures. [Background technology]

[0002] A catheter may be a hollow, flexible structure used for a variety of applications and procedures within a patient's vasculature. Often, a catheter may be directed to a target area within a particular vessel and then act as a guide through its lumen for other, more conventional, specialized devices to access said area. Such devices may include microcatheters, guidewires, clot retrieval devices, aspiration catheters, or any of a number of other commercially available accessory components.

[0003] Balloon guide catheters are used in standard arterial or ischemic stroke procedures to serve as conduits for diagnostic and therapeutic devices while also providing flow stop, flow control and / or reverse flow to aid in the safe retrieval of clots from the patient. This flow control provides distal vascular protection, which is important to minimize the risk of embolic migration and other procedural complications, especially in the small and vulnerable brain passages of stroke patients. Furthermore, the proximal flow control provided by these catheters has been shown to correlate with better angiographic and clinical outcomes. These catheters are useful in reducing procedure time and labor during the recanalization process of mechanical thrombectomy procedures in arteries. They can limit the number of clot retrieval attempts required during, for example, an ischemic stroke, and also reduce the occurrence of distal emboli.

[0004] Balloon guide catheters must be sufficiently flexible while possessing axial stiffness to be smoothly delivered through tortuous vasculature to the target site (typically within the internal carotid artery and cerebral vasculature in ischemic stroke patients). The device must also be designed to be as atraumatic as possible while still providing a high level of performance. Once access to the target is gained and the balloon is deployed, the guide catheter must be recognizably robust to remain stable in position while other devices are advanced, manipulated, and retracted through the lumen. The lumen itself must be large enough in diameter for these devices to direct the more efficient suction required to remove blood and thrombotic material during the procedure. However, the size of the lumen must be balanced by the need for the thinnest possible outer diameter to minimize the size of the entrance opening that must be closed once the catheter is removed from the patient.

[0005] Current designs must balance these tradeoffs, and one of the most significant challenges, and one that prevents more widespread adoption of these catheters, is the process of preparing the catheter for use. Currently, before introducing a balloon guide catheter into a vessel, physicians must flush the balloon and purge the air system before introducing any inflation media. Current practices used to remove air from the inflation lumens of existing catheters are laborious, slow, and frustrating, and can lead to substantial waste. In addition, it can be difficult to identify the difference between a "significantly purged" system and a "fully purged" system. However, failure to complete the purging process can result in complications such as cavitation, uneven inflation, and the release of trapped air pockets if the balloon ruptures during the procedure. These occurrences have the potential to cause neurological deficits or other complications.

[0006] Currently, the typical process for purging most balloon guide catheter systems involves first connecting a stopcock to the proximal port fitting of the catheter. A syringe is partially filled with contrast or other liquid and connected to the stopcock. The syringe plunger is then actuated and held to aspirate the inflation lumen and balloon of the catheter. During this process, trapped air in the form of air bubbles is drawn into the liquid in the syringe. The evacuated inflation lumen is filled with contrast in the syringe by releasing the plunger. This procedure is repeated until no air bubbles are observed during aspiration. A separate syringe can then be attached to the stopcock, contrast can be injected, and the balloon can be inflated. The balloon can then be inspected for leaks or other defects. The syringe can then be used to deflate the balloon and insert it into the vasculature. In some cases, air bubbles persist to the point that the balloon guide catheter must be discarded and a new balloon guide catheter must be procured and prepared. This demanding process not only requires care and can be frustrating for the user, but also adds significant time to the overall duration of the thrombectomy procedure, which can result in reluctance to adopt and use these devices during procedures where patient outcomes could be improved. Summary of the Invention [Problem to be solved by the invention]

[0007] Especially in ischemic stroke patients, there is always a need to shorten the groin puncture to reperfusion time to limit lasting damage. The present design aims to provide an improved balloon guide catheter that addresses the described deficiencies and gives the user a very high degree of adaptability during the procedure. [Means for solving the problem]

[0008] The object of the present invention is designed to provide a system, device, and method that meets the above-mentioned needs. As shown in the current design, having a balloon guide catheter that does not require cumbersome preparation steps by the physician prior to use can significantly reduce procedure time and therefore result in better clinical outcomes.

[0009] The current design facilitates preparation of the balloon guide catheter prior to balloon inflation in a mechanical thrombectomy procedure. The design accomplishes this objective by incorporating a removable mandrel into the catheter that serves to occupy the nominal volume of the inflation lumen prior to inflating the balloon. The mandrel occludes the lumen, thereby eliminating the presence of trapped gas within the system that would otherwise need to be evacuated prior to the medical procedure. When the physician is ready to inflate the balloon, the mandrel is withdrawn from the system, thereby allowing a vacuum to be drawn within the inflation lumen. If no trapped gas is present, the balloon can then be inflated using techniques known in the art.

[0010] Disclosed herein are various exemplary devices and methods for minimizing the preparation required to inflate a balloon of a balloon guide catheter. In addition, the disclosed devices address other deficiencies in the art, such as maximizing lumen kinking protection and clot retrieval effectiveness.

[0011] The system may generally include a balloon guide catheter having a tubular inner core with an inner hollow catheter lumen. The elongated tubular member may be disposed around, but not concentric with, the inner core. The elongated tubular member may have a proximal end, a distal end proximal to the distal end of the inner core, and a separate inflation sleeve defining an inflation lumen independent of the inner hollow lumen. The inner hollow lumen may extend between the proximal and distal ends of the inner core. The inner hollow lumen may be sized to maximize clot retrieval capabilities and may be a conduit for a microcatheter, a guidewire, a clot retrieval device, an aspiration catheter, or any of a number of other commercially available accessory devices. The inflation lumen may extend the majority of the length of the inner core from an inflation port at the proximal end of the elongated tubular member to the inside of a balloon at the distal end of the elongated tubular member. The balloon may be secured to a distal portion of the tubular inner core or may be secured near the distal end of the elongated tubular member.

[0012] The proximal end of the catheter may be approximated as a luer having a proximal end, a distal end integral with the elongate tubular member, and an internal luer lumen. The luer may further have an inflation inlet providing a passageway fluidly connecting the luer lumen to the inflation lumen of the elongate tubular member. The luer may have an inflation port and a mandrel hub, both of which may communicate with the internal luer lumen.

[0013] The mandrel hub of the luer can have a proximal port with a mandrel disposed therethrough and extending distally from the port the entire length of the inflation sleeve. The mandrel can be removably disposed within the mandrel hub of the luer and the inflation sleeve. The mandrel can have a distal end and an opposing proximal end that can include a mandrel tab. The mandrel tab can extend proximal to the proximal port and exterior to the luer. The mandrel is sized to occlude and occupy the entire volume of the inflation lumen. The mandrel can have an extended dimension to extend the distance between the mandrel hub and the balloon proximate the distal end of the balloon guide catheter. The mandrel hub proximal port can further have an air seal through which the mandrel passes. The air seal prevents air ingress into the luer lumen and the inflation lumen regardless of whether the mandrel is present.

[0014] The lumen of the inflation sleeve is in fluid communication with the balloon and can serve as a channel for inflating and deflating the balloon. The inflation sleeve can have any of a number of shapes, but generally has a smaller cross-section than the inner hollow lumen. In one embodiment, the inflation sleeve has a substantially crescent-shaped cross-section. The inflation sleeve can be formed from polyethylene (PE), polyethylene terephthalate (PET), polytetrafluoroethylene (PTFE), or similar fluoropolymers.

[0015] Tortuosity can induce forces on the body of the catheter, and in cases of extreme or steep angulation, one or more of the inner catheter lumens or the inflation lumens can become kinked. A kinked inner hollow lumen can restrict or completely prevent movement or operation of other devices within it. A kinked inflation lumen can block flow to or from the balloon near the distal end of the catheter. These situations can cause complications during the procedure because a non-functioning balloon guide catheter may need to be removed, the physician may need to perform the procedure without hemostasis, or an additional tube may need to be inserted through the inflation lumen to deflate the balloon. These situations also increase the time of the procedure.

[0016] To reduce the possibility of kinking, the elongated tubular member may have, for example, a reinforcing wire or braid system to support and secure the inner hollow lumen and the inflation lumen. The wire system may be embedded within the catheter and wrapped around the lumen to protect the inflation lumen and the inner hollow lumen along at least a portion of the length of the elongated tubular member. The wire may also improve torque capability along the length of the catheter while protecting the inflation lumen from kinking. The wire system may be on and / or around the inflation sleeve and may radially bond the sleeve to the inner core. The mesh system may be a braided wire network or some similar structure that improves the strength of the catheter while reducing its overall stiffness. Other wire configurations, such as coiled, may be able to introduce stiffness gradients along various lengths of the catheter. Strength and flexibility may also be affected if the individual wires have round, square, or some other shape profile.

[0017] Another system for preparing a balloon guide catheter may comprise an elongate tubular member, a proximal luer, and a seamless balloon.

[0018] The elongated tubular member may have a proximal end, a distal end, an outer surface, and two inner surfaces. The first inner surface may define an inner hollow lumen extending between the proximal and distal ends of the elongated tubular member for delivery of other catheters and / or devices to a target site. The second inner surface may define an inflation lumen extending at least a portion of the length between the proximal and distal ends of the elongated tubular member. The inflation lumen may be at least partially eccentric relative to the elongated tubular member and the inner hollow lumen. As with other embodiments, a reinforcing braid or wire network may be disposed around the outer surface of the inner hollow lumen and the outer surface of the inflation lumen to provide kink protection. The inflation lumen may have an arc or crescent shaped cross section and an area smaller than the area of ​​the inner hollow lumen, allowing the inflation lumen to be disposed off-center and proximate to the outer edge of the elongated tubular member. This inflation lumen configuration allows a larger inner hollow lumen to occupy a majority of the cross-sectional area of ​​the elongate tubular member, thereby improving the delivery capabilities of other devices and improving aspiration efficiency.

[0019] The proximal Luer may include an inner lumen, an inflation port sized to receive fluid infusion, a mandrel hub sized to receive a mandrel, and an air seal disposed within the mandrel hub to prevent air ingress into the inflation lumen of the elongate tubular member. The mandrel may be removably disposed within the mandrel hub and extend into and through the inflation sleeve via an inlet proximate the proximal end of the elongate tubular member. The inlet may provide a fluid passageway through an outer wall of the elongate tubular member between the inflation lumen and the Luer lumen.

[0020] The mandrel can be sized to completely occlude the entire length and volume of the inflation lumen such that there is no pre-existing gas in the inflation lumen that may require repeated attempts to evacuate to prepare the balloon for inflation. The occluding distal portion of the mandrel can have a length that spans the distance between the proximal port of the mandrel hub and the balloon present at the distal end of the elongate tubular member. The proximal end of the mandrel can include a tab that extends outside of the luer and can be used by the user to grasp and extract the mandrel body from the system when the physician is ready to inflate the balloon.

[0021] A seamless balloon may be secured to the distal end of the elongated tubular member. The balloon may be joined to the elongated tubular member by a mechanical member, such as an annular bonding band, or may be attached by adhesive or other means. The balloon may be made soft and highly flexible by selecting a particular material of construction, such as silicone, elastomeric alloy, or a blend of similar materials. When inflated, the balloon may provide a means of fixing the position of the catheter within the vessel. In addition, the balloon may stop blood flow, thereby improving the efficiency of any suction through the inner lumen of the balloon guide catheter and / or other associated catheters used with the balloon guide catheter. Suction is used to retrieve the clot and prevent distal migration of clot fragments that could potentially result in embolization of downstream distal vessels.

[0022] The larger inner hollow lumen of the elongated tubular member provides an easier conduit for delivery of ancillary products, such as intermediate or aspiration catheters, microcatheters, and clot retrieval devices, to the target site. The large mouth opening to the lumen also simplifies retraction of such devices with trapped clots.

[0023] Also provided is a method for utilizing a balloon guide catheter system that requires minimal preparation for inflating the balloon. The method may include any or all of the following steps and variations thereof, the steps being listed in any order.

[0024] A system may be selected that includes a balloon guide catheter that may have a proximal end, a distal end, an inner hollow lumen, an inflation sleeve defining an inflation lumen, a balloon, and a proximal luer. The luer may include an injection port, a mandrel hub, and a luer lumen in fluid communication with the inflation lumen.

[0025] An air seal may be provided at the proximal end of the mandrel hub to prevent air from entering the Luer lumen. A mandrel may be disposed within the mandrel hub through the air seal, which is removable and may be extended distally to occlude the entire volume of the inflation lumen.

[0026] Access to the patient's vasculature is achieved using techniques known in the art, and a balloon guide catheter can be advanced into the vasculature to a location proximal to the target site. The Luer lumen can be filled with an inflation media liquid through the Luer inflation port using a syringe or other inflation source. The liquid media is typically a contrast agent, saline, or a mixture of the two. The proximal tab can then be pulled to extract the mandrel from the catheter and draw a vacuum in the inflation lumen, allowing the inflation media in the Luer lumen to fill the inflation lumen along the length of the catheter. The balloon can be inflated by injecting additional inflation media from the inflation source.

[0027] The method may further include steps in which other devices are used in conjunction with the balloon guide catheter. For example, mechanical thrombectomy may be performed using techniques known in the art. Any number of commercial products are available for these procedures, and thus the method is not limited to those mentioned herein.

[0028] The process may include an intermediate catheter or aspiration catheter advanced through the inner lumen of the balloon guide catheter to the target site to aspirate the occlusive thrombus into the port of the catheter. Similarly, an alternative process may utilize a microcatheter with a clot retrieval device advanced through the lumen of the balloon guide catheter. The microcatheter may be advanced across the occlusive thrombus, and the clot retrieval device may be deployed to capture and retrieve the thrombus by aspiration through the balloon guide catheter. In a further example, the microcatheter with the clot retrieval device may have an access catheter or intermediate catheter as an outer sheath. The intermediate catheter, microcatheter, and clot retrieval device may be advanced through the lumen of the balloon guide catheter to the target site. The clot retrieval device may then capture and retrieve the thrombus.

[0029] In any of the foregoing embodiments, aspiration may be administered through any combination of balloon guide catheters, intermediate catheters, or other associated aspiration catheters used during thrombus retrieval.

[0030] The balloon can be deflated by applying suction to the inflation port of the Luer to withdraw the inflation media. Once the procedure is complete, the system can be withdrawn from the vasculature.

[0031] Other aspects and features of the present disclosure will become apparent to those of ordinary skill in the art upon consideration of the following detailed description in conjunction with the accompanying figures. [Brief description of the drawings]

[0032] The above and further aspects of the present invention are further considered in conjunction with the following description of the accompanying drawings, in which like numerals in the various drawings indicate like structural elements and features. The drawings are not necessarily to scale, emphasis instead being placed on illustrating the principles of the present invention. The figures depict one or more implementations of the device of the present invention, by way of example only and not by way of limitation. It is expected that those skilled in the art may conceive and combine elements from multiple drawings to better suit the needs of the user. [Figure 1] FIG. 1 is a diagram of a system having a balloon guide catheter, according to an embodiment of the present invention. [Diagram 2] 1 shows a closer isometric cutaway view of a distal end of a balloon guide catheter with an inflated balloon, according to an embodiment of the present invention. [Diagram 3] 3 shows a side cross-sectional view of the distal end of the balloon guide catheter of FIG. 2 in accordance with an embodiment of the present invention. [Figure 4] FIG. 4 is a cross-sectional view of the catheter tip of FIG. 3 according to an embodiment of the invention. [Diagram 5] 4 is another cross-sectional view of the catheter tip of FIG. 3, showing the inner lumen, according to an embodiment of the invention. [Figure 6] FIG. 2 is a side view of a proximal luer of a balloon guide catheter according to an embodiment of the present invention. [Figure 7] FIG. 7 is a cross-sectional view of the luer of FIG. 6 with a mandrel showing the internal flow passages, according to an embodiment of the present invention. [Figure 8] FIG. 8 is an inlay detail of the area around the expansion inlet of FIG. 7 with a mandrel, according to an embodiment of the invention. [Figure 9] 9 is a cross-sectional view of FIG. 8 from downstream of the inflation inlet with a mandrel occluding the inflation lumen, in accordance with an embodiment of the invention. [Figure 10] 9 is another cross-sectional view of FIG. 8 at the expansion inlet, according to an embodiment of the present invention. [Figure 11A] 1 is a process diagram of a mandrel being withdrawn from a balloon guide catheter and inflation medium filling the empty inflation lumen, according to an embodiment of the present invention. [Figure 11B]1 is a process diagram of a mandrel being withdrawn from a balloon guide catheter and inflation medium filling the empty inflation lumen, according to an embodiment of the present invention. [Figure 12] FIG. 1 is an isometric view of a mandrel separate from a balloon guide catheter, according to an embodiment of the present invention. [Figure 13] 1 illustrates a balloon guide catheter used in conjunction with an intermediate catheter, a microcatheter, and a clot retrieval device to capture a target occlusion in a blood vessel, according to an embodiment of the present invention. [Figure 14] 1 shows a distal end of a balloon guide catheter having a microcatheter and a clot retrieval device according to an embodiment of the present invention. [Figure 15] FIG. 1 is a flow diagram outlining one possible method for using a system according to an embodiment of the present invention. [Figure 16] FIG. 1 is a flow diagram outlining one possible method for using a system according to an embodiment of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0033] Specific embodiments of the present invention will now be described in detail with reference to the drawings, where like reference numbers indicate functionally similar or identical elements. The embodiments address many of the deficiencies associated with the preparation of conventional balloon guide catheters for inflating a balloon, and can result in significant reductions in procedure time and waste by eliminating steps and processes.

[0034] Accessing various blood vessels therein, whether coronary, pulmonary, or cerebral, involves well-known procedural steps and the use of numerous conventional, commercially available accessory products. These products, such as angiographic materials, rotating hemostatic valves, and guidewires, are widely used in laboratories and medical procedures. When these products are used with the systems and methods of the present invention in the following description, their functions and exact configurations will not be described in detail.

[0035] Referring to the figures, in FIG. 1, a system 100 for preparing a balloon guide catheter 110 for use in a procedure is shown. As shown, the catheter 110 of the system can have a proximal luer 118, an inner hollow lumen 114, a removable mandrel 216, and a catheter tip 112 proximate the distal end 116 of the catheter. The inner hollow lumen can be used for delivery of other catheters and ancillary devices to the target site, while also providing a channel for aspiration and injection of contrast media. The size of the lumen can vary based on the target site, or a standard guide catheter inner diameter of about 0.087 inches can be used. The luer can be integrally formed or coupled to the distal tubular body of the catheter.

[0036] FIG. 2 shows an isometric cutaway view of the catheter tip 112 of the balloon guide catheter of FIG. 1. The catheter body has an elongated tubular member 310 disposed about a tubular inner core 115. The inner core can be relatively thin-walled such that an inner hollow lumen 114 extending therethrough has a large cross-sectional area for the passage of suction and other devices. The inner hollow lumen can define a longitudinal axis 111 such that the elongated tubular member 310 is at least partially eccentric relative to the inner core 115 and the longitudinal axis 111. The smaller diameter of the inner core compared to the diameter of the elongated tubular member allows the balloon to lie flush with the transverse profile of the catheter when the balloon is deflated. The flush mounting provides a smoother delivery profile for the catheter. The balloon 113 can be secured at its proximal end to the elongated tubular member 310 and at its distal end to the inner core 115.

[0037] The elongated tubular member 310 has an inflation lumen 117 that extends parallel to the longitudinal axis 111 and may terminate at the distal end of the inner elongated tubular member inside the balloon 113. The elongated tubular member and the inflation lumen may extend the majority of the length of the inner core 115. Prior to inflation of the balloon, the mandrel 216 occupies the inflation lumen that extends from the interior of the proximal luer 118 to the distal end of the elongated tubular member 310. The inflation lumen may be smaller than the inner hollow lumen because the volume of inflation medium required to inflate the balloon is typically insubstantial. The inflation lumen may be crescent shaped and may be approximately or about 0.2 mm. 2 This inflation lumen shape maximizes the interior space of the elongate tubular member 310 such that a majority of the cross section is occupied by the inner hollow lumen 114. The larger inner diameter of the inner hollow lumen facilitates delivery of devices, contrast media, and more efficient aspiration.

[0038] It should be noted that, as used herein, while elements are described and visualized in the drawings as tubular structures and generally illustrated as substantially right cylindrical structures, the terms "tubular" and "tube" should be interpreted broadly and are not meant to be limited to right cylindrical structures, or structures that are strictly circular in cross section, or of uniform cross section along their length.

[0039] A side view of the distal catheter tip 112 of the balloon guide catheter is shown in FIG. 3. The inner hollow lumen 114 may extend longitudinally with the inflation lumen 117 of the inflation sleeve 119 and terminate at the distal end 116 of the inner core 115. The inflation lumen may extend the entire length of the elongated tubular member 310 to the distal end 316 and exit into the balloon lumen 126. An inflation media fluid, often a 50 / 50 contrast mixture, may be injected into the proximal luer to provide fluid flow within the inflation lumen. Fluid may flow through the length of the inflation lumen and into the balloon lumen as indicated by the arrows.

[0040] The balloon 113 may assume an oval or tapered shape when inflated with atraumatically widened radius of curvature to interact with the vessel wall. The balloon may be secured to the distal end of the elongated tubular member. The balloon may be bonded to the outer surface 316 of the elongated tubular member 310 by a mechanical member such as a ring-shaped tie band or strap, or may be attached by crimping, welding, or other means. In one embodiment, the balloon is attached using a suitable adhesive means such as an epoxy or cyanoacrylate.

[0041] The body of the elongated tubular member 310 may be cut from a hypodermic tube or one or more outer jackets may be laminated, injection molded, or reflowed and placed on it. In one embodiment, the elongated tubular member is cut from a hypodermic tube that has high column strength, allowing good pressure and torque characteristics, small bend radius strain capacity, and high kink resistance. Commonly used hypodermic tube materials include Nitinol and well-known stainless steel alloys such as 304 and 316. The elongated tubular member may have a uniform stiffness over its length or may have a stiffness that varies along the length of the elongated tubular member. The variation in stiffness profile of the catheter may be created by laser cutting features such as circumferential slots or grooves, or patterned ridges or recesses that are offset longitudinally or axially may be machined.

[0042] In other examples, the elongate tubular member 310 can be made from a polymer tube or one or more multi-durometer polymer jackets. During manufacturing, one or more jackets or portions of the jacket can be fused using heat. Variations introduced in the axial or radial placement of the jacket can tailor the axial and lateral stiffness profile from the proximal end to the distal end. For example, the jacket can be axially configured to transition the overall stiffness of the catheter from a stiffer proximal end to a highly flexible distal end.

[0043] The surface of the polymer tube can also be contoured with a series of ridges and recesses that provide enhanced torque, pressure, and trackability characteristics. Both the inner and outer surfaces of the catheter can be made from or coated with a lubricious, low-friction material, such as PTFE. This ensures that as the catheter is navigated through the blood vessel, there is a smooth, non-abrasive surface to contact the interior vessel wall along the path to the target site.

[0044] To achieve the desired stiffness, materials and / or additives having the desired stiffness properties can be used in the construction of the elongated tubular member. The materials and / or additives can be varied along the length of the elongated tubular member to create sections with different stiffness, each section being of a different hardness or durometer. Additional layers or additives can be provided to control the individual stiffness of sections of the elongated tubular member. However, it is desirable for the axial stiffness transition to be relatively gradual, otherwise the catheter may be forced to kink in areas of abrupt changes in flexibility.

[0045] In a further example, the elongate tubular member 310 can have a proximal end, a distal end, an outer surface 316, and two inner surfaces. The first inner surface 115 can define an inner hollow lumen 114 for delivering auxiliary devices or for delivering suction or contrast. The first inner surface can be at least partially eccentric with respect to the elongate tubular member. The second inner surface 119 can define an inflation lumen 117 extending therethrough that can have an arc or crescent shaped cross section. In this manner, the inflation lumen can be smaller than the inner hollow lumen, allowing for a smaller interior volume of the elongate tubular member.

[0046] Figures 4 and 5 are cross-sectional views of the catheter tip of Figure 3. Figure 4 shows a cross-sectional view of the catheter tip through an inflated balloon 113. The respective profiles of the balloon lumens 126, the inflation lumen 117, and the inner hollow lumen 114 can be seen. The balloon can have a circular profile when inflated as shown, or can assume another shape designed for a particular procedure.

[0047] The inflation lumen 117 can serve as a conduit for inflation media to inflate and deflate the balloon 113. The inflation lumen can connect to a port at the proximal end of the catheter and extend the majority of the length of the elongated tubular member and be routed inside the balloon lumen. The inflation lumen can have any number of shapes, including but not limited to specific arc radius dimensions. The inflation lumen can be a sleeve of polytetrafluoroethylene (PTFE), polyethylene (PE), polyethylene terephthalate (PET), fluorinated ethylene propylene (FEP), or the like.

[0048] The balloons can be constructed of any of a number of materials, such as Chronoprene, polyurethane, nylon, PBx, or another thermoplastic elastomer. These materials allow the balloons to be durable and low profile. The balloons may or may not be gas permeable, as they do not require air to diffuse out of the balloon during preparation. The outer surface of the balloon can be coated with a hydrophilic coating for atraumatic lubricity, and the balloon can be molded so that there is a minimal contact strip with the vessel wall upon inflation.

[0049] Advancement through particularly tortuous vasculature can cause the catheter 110 and associated lumens to kink or crimp. Kinking of the inner hollow lumen 114 can result in binding on a guidewire or other device. A kinked inflation lumen 117 can block flow to and from the balloon of the balloon guide catheter, which can reduce or completely prevent the rate of balloon inflation or deflation. In extreme cases, a kinked inflation lumen can result in complete failure of the balloon or an inability to inflate or deflate the balloon. This can cause complications during the procedure, as the non-functioning balloon guide catheter may need to be removed, the physician may need to perform the procedure without stopping the flow, or some other device may need to be inserted through the inflation lumen to deflate the balloon.

[0050] To combat kinking, the catheter profile may include a reinforcing wire configuration or braided mesh 318 along the length of the catheter that connects the outer surface of the inflation sleeve 119 to the outer surface of the inner core 115, as seen in the cross-sectional view of FIG. 5. The reinforcing mesh may be encased within the polymer tube of the elongated tubular member 310 and may act similar to rebar to prevent kinking of the catheter while maintaining consistent lateral flexibility for stable trackability. The reinforcing mesh may be of consistent structure and spacing along the axis of the catheter, or may vary in shape and density along various lengths. For example, altering the mesh profile may increase the flexibility of the distal end of the catheter while minimizing the possibility of kinking of the inflation lumen. The strands may be executed in a substantially parallel manner or in a crisp configuration.

[0051] Other embodiments can vary the geometry of the coils to reduce the bending stiffness of the catheter 110 compared to braiding. The density of the coils or the materials used in their construction can be adjusted to change the axial stiffness profile of the catheter. Adding coils instead of braiding reduces this "whip" orientation around sharp bends or loops in the vessel.

[0052] The elongated tubular member 310 may also have an outer surface 316 that includes one or more outer jackets or liners that provide a reduced friction surface. The jackets or jackets may be laminated, injection molded, or reflowed into place. Both the outer surface 316 of the elongated tubular member and the surface of the inner hollow lumen 114 may be coated with a lubricious low friction coating, such as PTFE, high density polyethylene, or similar fluoropolymers. The coating may be applied by spray, plasma, or any other applicable method that is smooth and uniform. As the catheter is navigated through the vessel, the outer jacket may be effective in providing a uniform surface to glide along the inside of the vessel without scratching or abrading the vessel or creating excessive frictional forces that resist the catheter being delivered to the treatment site. Similarly, a coating or liner on the inner hollow lumen would facilitate the advancement and navigation of other devices through the lumen.

[0053] FIG. 6 shows a luer 118 proximate the proximal end 121 of the balloon guide catheter. The luer can be a self-sealing connector with typical joints for receiving attachments. The luer can be a rigid housing having a proximal end forming the proximal end 121 of the catheter, a distal end 211, an inflation port 210, and a mandrel hub 214. The luer housing is configured to be hermetically sealed during use. The proximal end can serve as an inlet for other devices used in the intravascular procedure. An elongated tubular member 310 as seen in the previous figure can be housed proximally within the luer and can extend downstream from the distal end 211 of the luer. The inflation port 210 can branch radially away from the longitudinal body portion of the luer. The port can be sized to receive or deliver fluid to or from a syringe. The luer can have a mandrel hub 214 as a separate stem from the body, and a removable mandrel 216 can be positioned within the catheter proximal to the mandrel hub and out of the luer 118. Actuation of the mandrel is accomplished by manipulating the mandrel tab 217 at the proximal end of the mandrel. The mandrel can be removed by applying tension to the mandrel tab and sliding the mandrel out of the mandrel hub.

[0054] Luer 118 shown in Figure 6 and other figures are used to illustrate one embodiment of the design of the present invention. Of course, the design can be applied to other luers of various shapes, sizes, and utility, so long as the mandrel is accommodated as described.

[0055] A view of the interior of the Luer 118 without the removable mandrel is shown in FIG. 7. The Luer can have an internal lumen 212 that forms a hollow channel of the inflation port 210. An elongated tubular member 310 can be integrally joined or formed with the Luer housing. The elongated tubular member can begin at a proximal end 314 within the housing and extend distally. Access to the inflation lumen can be provided through an inflation inlet 222 through a sidewall of the elongated tubular member 310 and near its proximal end. The inflation inlet provides a fluid passageway between the Luer lumen and the inflation lumen to allow for inflation and deflation of the balloon through the Luer.

[0056] An air seal 218 may be disposed at the proximal end of the mandrel hub 214. The seal may be a compression gasket or other such methods known in the art. The proximal end of the seal may be flush with the outer surface of the mandrel hub, extend from, or be recessed therefrom. The air seal provides the utility of maintaining a pressure barrier and preventing air ingress into the luer even when the removable mandrel is removed from the mandrel hub. Thus, the seal secures the internal catheter environment from contamination when the mandrel has performed its function. The seal may also prevent air bubbles from being trapped during inflation or deflation of the balloon.

[0057] A detailed view of the interior of the luer 118 of FIG. 7, including the mandrel 216 profile, is shown in FIG. 8. Prior to balloon inflation, at least a length of the mandrel 216 can extend through an air seal 218 at the mandrel hub proximal port 220 to exit the luer and provide an external gripping surface for the user. Inside the luer, the mandrel can pass through the mandrel hub 214 and enter the inflation sleeve 119 of the elongated tubular member 310 via or proximal to the inflation inlet 222. The luer lumen 212 can function as a small volume reservoir when the mandrel 216 is in place, blocking fluid access to the inflation sleeve through the inflation inlet. Entry of the mandrel into the inflation sleeve can occur proximal to or through the inflation inlet itself.

[0058] A detailed view of the interface around the inflation inlet 222 is also shown in FIG. 8. The mandrel 216 may be a flexible elastomer or other material with a high elastic strain limit so that it can be bent from the radially offset mandrel hub 214 to the substantially longitudinal inflation sleeve 119 of the elongated tubular member 310. The inflation inlet may be shaped to facilitate this transitional bend. In one embodiment, the longitudinal shape of the inflation inlet may be tapered such that as the mandrel is inserted and fed from the mandrel hub into the catheter, the taper funnels the distal end of the mandrel into the inflation inlet and the inflation lumen. From the inflation inlet, the mandrel advances distally, and in this "off-axis" configuration, the mandrel advances distally and occludes the entire interior volume of the inflation lumen. In this way, the mandrel prevents any gas or other medium from occupying the inflation lumen prior to use of the balloon guide catheter and initial inflation of the balloon.

[0059] A cross-sectional view of the elongated tubular member 310 from FIG. 8 distal and downstream of the inflation inlet is shown in FIG. 9. The elongated tubular member can be integrally formed with the luer, or the outer surface 316 of the elongated tubular member can be bonded or press-fit within the luer housing. The elongated tubular member can have at least two inner surfaces. A first inner surface can define the inner core 115 and the inner hollow lumen 114 extending through the interior. A second inner surface can define an inflation sleeve 119 detailing the circumference of the inflation lumen 117. As with other examples, the cross-section of the inflation lumen can be smaller than the cross-section of the inner hollow lumen. The inflation lumen 117 occupied by the mandrel 216 prior to balloon inflation can be in a radially upward or "12 o'clock" orientation relative to the inner core 115 and inner hollow lumen 114, or some other clocking orientation. The reinforcing braid or mesh 318 may have interlocking strands and extend around the outer surface of the inner core and the inflation sleeve. The braid may be in a crossover configuration, helical orientation, or some other means to strengthen and provide kink resistance to the catheter and lumen. The density of the reinforcing mesh may also be used to affect the stiffness properties of the catheter, allowing for a longitudinally stiffer, more flexible distal section.

[0060] Figure 10 also shows the cross-sectional view of Figure 8 through the luer 118 housing and elongate tubular member 310 at the axial location of the inflation inlet 222. The mandrel 216 occupies the crescent shaped cross-section of the inflation sleeve 119 prior to balloon inflation. Due to the shape of the inflation lumen 117, the inner core 115 and associated inner hollow lumen 114 are not concentric with the elongate tubular member 310. The cross-section of the expansion sleeve is crescent shaped in this example, however, if another shape is used for the expansion sleeve, the mandrel area may be adjusted to match that shape.

[0061] When the balloon guide catheter is advanced through the vasculature to the target site of the occlusive clot, the balloon can be inflated to stop flow within the vessel and block fluid proximal to the tip of the catheter. In most embodiments, the seamless balloon is inflated within the patient's vessel using contrast agent, saline, another neutral fluid, or a combination thereof. Typically, an equal part solution of contrast agent and saline is used. When the system is at the target site and the user is ready to inflate the balloon, a small amount of inflation medium 26 can be first injected into the stem of the inflation port 210 to pre-fill the Luer lumen 212 via an inflation source or syringe 25 as shown in FIG. 11A. Pre-filling the Luer lumen ensures that when the mandrel is removed from the catheter and access to the inflation lumen 117 through the inflation inlet 222 is opened, the vent space within the inflation lumen will be filled with contrast agent from the Luer lumen.

[0062] FIG. 11B illustrates the process of removal of the mandrel 216 when the operator is ready to inflate the balloon. The mandrel can be extracted proximally from the mandrel hub 214 of the luer 118 while the air seal 218 maintains a hermetic seal inside the luer. When the mandrel body passes through the wall thickness of the elongated tubular member 310 opening the inflation inlet 222, the volume of contrast agent 26 in the lumen 212 of the inflation port 210 is drawn into the inflation lumen 117 by the negative pressure gradient left by the mandrel removal. This eliminates the step required to purge the air that would nominally occupy the inflation lumen. The inner hollow lumen 114 of the inner core 315 is unobstructed during this fluid transfer. The mandrel may be completely removed from the luer or the tail may be left in some interior position between the inflation inlet and the mandrel hub proximal port 220. At this point, further injection of inflation medium into the inflation port will inflate the balloon. The fluid volume and / or pressure is held constant to keep the balloon 210 engaged with the vessel lumen and prevent flow past the balloon 210. Once the procedure is completed or the catheter is repositioned, the balloon can be deflated by pulling on the syringe plunger to withdraw the media.

[0063] FIG. 12 is an isometric view of the mandrel 216 independent of the catheter system. The body of the mandrel can take the crescent shape of the inflation sleeve to occupy the entire volume of the inflation lumen prior to balloon inflation. Navigation to the target site of the procedure can include torquing and small bend radii as well as deflection. As a result, the mandrel can be made of a highly elastic flexible material so that it can adapt to the pathway and associated strains imposed by the catheter body. The mandrel tabs 217 can be formed integrally with the mandrel or independent of the mandrel. The tabs can be any of a number of shapes so that they have features to be easily grasped and provide positive tactile feedback to the user. In one embodiment, the tabs can have ridges or a diamond plate pattern to enhance grip. The outer surface of the mandrel can be coated with a low friction lubricating coating that allows it to slide more freely when withdrawn from the catheter in preparation for inflating the balloon.

[0064] This design for a balloon guide catheter that requires minimal preparation to inflate the balloon can be used with other mechanical thrombectomy devices. With reference to FIG. 13, a balloon guide catheter 110 can be advanced through a target vessel 20 to a site proximal to an occlusive clot 40. A balloon 113 can be inflated to block proximal flow within the vessel. An access catheter, such as an intermediate catheter 35 or an aspiration catheter, can be advanced through the distal end of the balloon guide catheter to the target. A microcatheter 70 containing a clot retrieval device 60 can be advanced further through the intermediate catheter and balloon guide catheter and deployed to collect the clot 40 while aspiration is applied through one or more of the catheters. Once the clot has been collected, the clot retrieval device can be retracted into the intermediate catheter, which can compress the structure of the device and strengthen the grip it has on the clot during retrieval. The clot retrieval device 60, microcatheter 70, intermediate catheter 35, and clot 40 can then be retrieved from the balloon guide catheter 110 and completely removed from the patient.

[0065] When the system is used with other intermediate catheters or suction catheters, the system can use suction with one or more flow restrictors or seals that can be selectively activated to project suction to the distal lumen of the desired catheter. The seals can be hydrogel, annular inflatable balloon-type members, can take a molded O-ring profile, or can have a framework with a membrane coating. For example, the system can include an intermediate catheter 35 disposed within a balloon guide catheter 110, as shown in FIG. 13. When suction is applied to the proximal lumen of the balloon guide catheter and a circumferential seal is activated between the outer surface of the intermediate catheter and the inner surface of the balloon guide catheter, the full force of the suction can be translated to the distal tip of the intermediate catheter. Similarly, when the seal is not activated, the suction is divided between the intermediate catheter 35 and the balloon guide catheter 110.

[0066] The clot retrieval device 60 referred to herein may be any of a number of commercially available products, all of which share many common features. Some devices compress the clot during collection to obtain a firm grip, but this tends to create a firmness, or "sticker," of the clot, which can complicate retrieval. Other devices are intended to extend between the clot and the vessel to minimize compression while loosening the clot from the vessel wall.

[0067] Often such devices can be made from Nitinol or another shape memory material that has sufficient elastic strain capacity so that the elastic limit is not exceeded when the device 60 is in a collapsed delivery configuration within the microcatheter 70. This elastic strain capacity allows the device to be effectively "spring loaded" within the microcatheter so that it can self-expand and engage the clot when deployed from the distal end of the microcatheter.

[0068] Positioning of the balloon guide catheter during a procedure can be aided by the addition of a radiopaque marker, as is well known in the art. Such markers can include radiopaque alloying elements such as palladium, platinum, gold, and the like. For example, a radiopaque marker can be placed distal to the balloon at the distal tip of the catheter. A marker can be placed on the inner core to mark the end of the balloon during a procedure.

[0069] In another example, the balloon guide catheter 110 can be manipulated into the internal carotid artery, the balloon 113 can be inflated, and the microcatheter 70 and clot retrieval device 60 can be advanced through the lumen 114 and deployed directly from the distal end 116 of the balloon guide catheter tip 112. This standard method is shown in FIG. 14. The balloon can be inflated using processes previously described herein. The inflated balloon blocks blood proximal to the target location from interfering with clot capture, and suction can be applied through the balloon guide catheter to prevent distal migration of debris or debris from the target site. If additional retrieval attempts are required to clear the vessel, the microcatheter 70 and clot retrieval device 60 can be rapidly delivered to the target site.

[0070] 15 and 16 are flow diagrams including method steps for performing a mechanical thrombectomy procedure using such a system. The method steps may be performed by any of the exemplary systems, devices, and / or apparatus described herein or by means known to those of skill in the art. The described method steps may be efficiently performed without the associated labor-free purging steps associated with other balloon guide catheter systems.

[0071] With reference to method 1500 outlined in FIG. 15, step 1510, an operation is described for selecting a balloon guide catheter for a mechanical thrombectomy procedure. The balloon guide catheter can have a proximal end, a distal end, an inner hollow lumen, and a proximal luer having a luer lumen. In addition, the catheter can have an inflation sleeve defining an inflation lumen separate from the inner hollow lumen and a balloon for flow arrest and efficient aspiration at the target site. At step 1520, an air seal can be placed within the mandrel hub of the luer to prevent other contaminants from entering the luer lumen. Sealing can be accomplished by any of a number of methods known in the art for sealing medical devices. At step 1530, a removable mandrel is placed through the air seal distally occupying the entire volume of the inflation lumen to eliminate the presence of trapped gas in the system prior to inflation. At step 1540, access is gained to the patient's arterial vasculature using conventional well known techniques. At step 1550, a balloon guide catheter is advanced into and through the vessel to a location proximal to the occlusive clot using methods common in the art. At step 1560, the Luer lumen may be filled with a small amount of inflation media through the Luer inflation port. This step may be accomplished by injecting a fraction of the inflation media from a filled syringe. Alternatively, this step may include venting the Luer lumen with a gas permeable membrane.

[0072] Referring to method 1600 outlined in FIG. 16 at step 1610, a user can pull the proximal tab of the mandrel, removing the mandrel from the catheter and drawing a vacuum in the inflation lumen. Thus, the inflation media in the Luer lumen is drawn into the inflation lumen. The balloon can then be inflated by injecting additional inflation media through the inflation port of the Luer at step 1620.

[0073] Once the balloon is fully deployed, the occlusive clot can be removed by direct aspiration through the balloon guide catheter, as with a large distal internal carotid artery (ICA) occlusion. However, in many cases, the next steps involve variations using other means to retrieve the clot in a mechanical thrombectomy procedure. Such procedures are well known in the art, and the steps herein are not meant to be an exhaustive list. In step 1630, an intermediate catheter can be advanced through the balloon guide catheter to the target location and used to aspirate the occlusive thrombus. An alternative in step 1640 includes advancing a microcatheter and clot retrieval device through the balloon guide catheter to the target location and deploying the clot retrieval device to capture the occlusive thrombus with aspiration. In another example of step 1650, an intermediate catheter is advanced through the balloon guide catheter, and a microcatheter and clot retrieval device are advanced through the intermediate catheter to the target location. A microcatheter and clot retrieval device are advanced across the thrombus and the clot retrieval device, and the clot retrieval device is deployed to capture the thrombus with suction through one or more of the catheters. In step 1660, once the thrombus is retrieved, flow reversal is achieved by suction directed through the balloon guide catheter.

[0074] The present disclosure is not limited to the described examples, which may vary in configuration and details. The terms "distal" and "proximal" are used throughout the foregoing description and are meant to refer to a location and direction relative to the treating physician. Thus, "distal" or "distally" refers to a location away from the physician or a direction away from the physician. Similarly, "proximal" or "proximally" refers to a location closer to the physician or a direction toward the physician.

[0075] In describing the exemplary embodiments, terminology is utilized for clarity of discussion. Each term is intended to have its broadest meaning as understood by those skilled in the art and is intended to include all technical equivalents that operate in a similar manner to achieve a similar purpose. It should also be understood that a reference to one or more steps of a method does not preclude the presence of additional or intervening method steps between those steps that are explicitly identified. Each step of the method may be performed in a different order than that described herein without departing from the scope of the disclosed technology. Similarly, it should also be understood that a reference to one or more components in an apparatus or system does not preclude the presence of additional or intervening components between those components that are explicitly identified.

[0076] As discussed herein, a "patient" or "subject" can be a human or any animal. It should be understood that the animal can be of any of a variety of relevant types, including, but not limited to, mammals, veterinary animals, livestock animals, or pet animals. As an example, the animal can be a laboratory animal (e.g., rats, dogs, pigs, monkeys, etc.) that is specifically selected to have certain characteristics similar to humans.

[0077] "Comprising" or "containing" or "including" means that at least the specified compounds, elements, particles, or method steps are present in a composition or article or method, but does not exclude the presence of other such compounds, substances, particles, or method steps, even if those other compounds, substances, particles, or method steps have the same function as the one specified.

[0078] It should also be noted that, as used herein and in the appended claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. Ranges can be expressed herein as from "about" or "approximately" one particular value to "about" or "approximately" another particular value. When such a range is expressed, other exemplary embodiments also include from the one particular value to the other particular value.

[0079] The term "about" or "approximately" as used herein with respect to any numerical value or range of numerical values ​​indicates a suitable dimensional tolerance that allows a portion of a component or a collection of components to function according to its intended purpose as described herein. More specifically, "about" or "approximately" may refer to a range of values ​​of ±20% of the recited value, for example, "about 90%" may refer to a range of values ​​of 71% to 99%.

[0080] 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. Although specific examples of the present invention are described, various modifications to the apparatus and method can be made without departing from the scope and spirit of the present invention. For example, the examples described herein refer to specific components, but the present invention includes other examples that utilize combinations of various components to achieve the described functionality, utilize alternative materials to achieve the described functionality, combine components from various examples, combine components from various examples with known components, and the like. The present invention contemplates the replacement of component parts illustrated herein with other well-known commercially available products. These modifications will be apparent in many cases to those skilled in the art to which the present invention pertains, and are intended to be within the scope of the following "claims."

[0081] [Embodiment] (1) A system for preparing a balloon guide catheter, comprising: A catheter comprising: a substantially tubular inner core having an inner hollow lumen; an elongated tubular member disposed about the inner core, the elongated tubular member including an inflation sleeve having an inflation lumen extending therethrough, the elongated tubular member and the inflation sleeve extending along a majority of the length of the tubular inner core; A proximal lure, a proximal end and a distal end; With an internal lure lumen, an inflation port in fluid communication with the Luer lumen; a proximal luer comprising a mandrel hub having a proximal port, the mandrel hub in fluid communication with the luer lumen; a mandrel removably disposed within the mandrel hub and the expansion sleeve, the mandrel occupying an entire volume of the inflation lumen; a balloon in fluid communication with the inflation lumen of the inflation sleeve. (2) The system of embodiment 1, further comprising an inflation inlet fluidly connecting the Luer lumen and the inflation lumen. (3) The system of embodiment 1, wherein the inflation lumen is smaller than the inner hollow lumen. (4) The system of claim 1, wherein the expansion sleeve has a substantially crescent-shaped cross-section. (5) The system of claim 1, wherein the mandrel further comprises a tab extending proximally from the proximal port of the mandrel hub exterior to the luer.

[0082] (6) The system of embodiment 2, wherein the proximal port of the mandrel hub includes an air seal to prevent air ingress into the inflation lumen. (7) The system of embodiment 1, wherein the balloon is fixed to a distal portion of the tubular inner core. (8) The system of embodiment 1, wherein the elongated tubular member is configured to be at least partially eccentric with respect to the tubular inner core. (9) A system for preparing a balloon guide catheter, comprising: A catheter comprising: An elongated tubular member, A proximal end portion; A distal end portion. An outer surface; a first inner surface defining an inner hollow lumen extending therethrough, the inner hollow lumen being at least partially eccentric with respect to the elongate tubular member; an elongate tubular member having a second inner surface defining an inflation lumen extending therethrough; A proximal lure, An inner lumen; an inflation port sized to receive fluid injection; a mandrel hub sized to receive the mandrel; a proximal luer having an air seal disposed within the mandrel hub to prevent air from entering the inflation lumen of the elongated tubular member; a mandrel removably disposed within the mandrel hub; a catheter comprising a seamless balloon in fluid communication with the inflation lumen. (10) The system of embodiment 9, wherein the seamless balloon is fixed to the distal end of the elongated tubular member.

[0083] 11. The system of claim 9, wherein the mandrel is shaped to occlude an entire cross-section of the inflation lumen. (12) The system of embodiment 9, wherein the inflation lumen is smaller than the inner hollow lumen. (13) The system of embodiment 9, wherein the inflation lumen has a substantially crescent-shaped cross-section. (14) The system of embodiment 9, further comprising an inlet adjacent the proximal end of the elongate tubular member, the inlet providing a fluid passageway between the inflation lumen and the lumen of the proximal Luer. 15. The system of claim 14, wherein the mandrel is sized to occupy the entire volume of the inflation lumen.

[0084] (16) A method for preparing a balloon guide catheter, comprising: selecting a balloon guide catheter having proximal and distal ends, an inner hollow lumen, an inflation sleeve defining an inflation lumen, a balloon, and a proximal luer having a luer lumen; disposing an air seal within a mandrel hub of the luer to prevent air from entering the luer lumen; placing a removable mandrel through the air seal in the mandrel hub and extending distally to occupy an entire volume of the inflation lumen; accessing a patient's vasculature using techniques known in the art; advancing the balloon guide catheter into the vasculature; filling the luer lumen with an inflation medium through the inflation port of the luer; creating a vacuum in the inflation lumen by pulling a proximal tab to withdraw the mandrel from the mandrel hub such that the inflation media from the Luer lumen fills the inflation lumen along the length of the catheter; and inflating the balloon by injecting an inflation medium through the inflation port of the luer. (17) The method of embodiment 16, further comprising the step of advancing an intermediate catheter through the balloon guide catheter to the target location and aspirating the occlusive thrombus. (18) The method of embodiment 16, further comprising the steps of advancing a microcatheter and clot retrieval device through the balloon guide catheter to the target location, capturing an occlusive thrombus, and deploying the clot retrieval device to retrieve the thrombus by suction. (19) The method of embodiment 16, further comprising the steps of advancing an intermediate catheter, a microcatheter, and a clot retrieval device through the balloon guide catheter to the target location, capturing an occlusive thrombus, and deploying the clot retrieval device to retrieve the thrombus by suction. (20) The method of embodiment 16, further comprising the step of aspirating through the balloon guide catheter as the occlusive thrombus is retrieved.

Claims

1. 1. A system for preparing a balloon guide catheter, comprising: A catheter comprising: a substantially tubular inner core having an inner hollow lumen; an elongated tubular member disposed about the tubular inner core, the elongated tubular member including an inflation sleeve having an inflation lumen extending therethrough, the elongated tubular member and the inflation sleeve extending along a majority of the length of the tubular inner core; A proximal lure, a proximal end and a distal end; With an internal lure lumen, an inflation port in fluid communication with the internal Luer lumen; a proximal luer comprising a mandrel hub having a proximal port, the mandrel hub in fluid communication with the internal luer lumen; a mandrel removably disposed within the mandrel hub and the expansion sleeve, the mandrel occupying an entire volume of the inflation lumen; a balloon in fluid communication with the inflation lumen of the inflation sleeve.

2. 10. The system of claim 1, further comprising an inflation inlet in fluid communication with the internal Luer lumen and the inflation lumen.

3. The system of claim 1 , wherein the inflation lumen is smaller than the inner hollow lumen.

4. The system of claim 1 , wherein the expansion sleeve has a substantially crescent-shaped cross-section.

5. The system of claim 1 , wherein the mandrel further comprises a tab extending proximally from the proximal port of the mandrel hub exterior to the proximal luer.

6. The system of claim 2 , wherein the proximal port of the mandrel hub includes an air seal to prevent air ingress into the inflation lumen.

7. The system of claim 1 , wherein the balloon is secured to a distal portion of the tubular inner core.

8. The system of claim 1 , wherein the elongated tubular member is configured to be at least partially eccentric relative to the tubular inner core.

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