Single lumen balloon guide catheter

Abstract

A single-lumen balloon guide catheter is provided. A balloon catheter includes a tubular body and a balloon circumferentially surrounding a portion of the tubular body. The tubular body includes an outer surface and an inner surface defining an inner lumen of the tubular body. The balloon includes a proximal portion, a distal portion, and an expandable portion, each of the proximal portion and the distal portion being secured to the tubular body, the expandable portion defining an interior in fluid communication with the inner lumen of the tubular body. The distal portion of the balloon extends through the outer surface and the inner surface into the inner lumen of the tubular body, forming a sealed portion circumferentially surrounding the inner surface of the tubular body. A catheter assembly including the balloon catheter and a method of use are also provided.

Description

[0001] Cross-reference to related applications

[0002] This application claims priority to U.S. Provisional Patent Application No. 63 / 410,627, filed on September 28, 2022, entitled “Single Lumen Balloon Guide Catheter,” the disclosure of which is hereby incorporated by reference in its entirety. Technical Field

[0003] This application generally relates to medical devices and methods of using medical devices. Specifically, various embodiments of balloon guiding catheters and methods of manufacturing and using balloon catheters are described. Background Technology

[0004] Balloon-guided catheters (BGCs) are known and have been used in a variety of medical procedures, including thrombectomy and other interventional and diagnostic procedures. A standard double-lumen balloon-guided catheter consists of an inner and outer catheter body, forming an inflatable lumen between the two bodies. Another type of standard balloon-guided catheter consists of a catheter body and a large inflatable lumen along the sides of the catheter body. Both types of standard balloon-guided catheters reduce the usable lumen size for a given outer diameter. Furthermore, removing air from a standard balloon-guided catheter is difficult, making preparation for use lengthy and complicated. Before using a balloon-guided catheter, air must be removed from the catheter so that the user can visualize the balloon inflated by the contrast agent. If air is not removed, the balloon with air present cannot be seen by the user, posing a risk of overinflation and rupture. Another reason for minimizing the presence of air in the balloon-guided catheter is that in the event of balloon rupture, no air is released into the blood vessel, avoiding the risk of air embolism, such as in intracranial arteries. The reduced usable lumen size and longer preparation time of balloon-guided catheters of a given French size have significantly hampered their use in the treatment of stroke and other conditions. However, clinical data have shown that balloon-guided catheters can provide good performance in medical procedures.

[0005] Therefore, there remains a general need to improve balloon-guided catheters. The aim is to provide a balloon-guided catheter that allows for a large usable lumen size for a given outer diameter and enables rapid readiness for use. Summary of the Invention

[0006] In one aspect, embodiments of the present disclosure feature a balloon catheter. Generally, embodiments of the balloon catheter include a tubular body and a balloon circumferentially surrounding a portion of the tubular body (e.g., a distal end of the tubular body). The tubular body includes an outer surface and an inner surface defining an inner lumen of the tubular body. The balloon includes a proximal portion and a distal portion each secured to the tubular body and an expandable portion defining an interior in fluid communication with the inner lumen of the tubular body. The distal portion of the balloon extends through the outer surface and the inner surface into the inner lumen of the tubular body forming a sealed portion circumferentially surrounding the inner surface of the tubular body.

[0007] In various embodiments of this aspect, the balloon can be positioned adjacent to a distal portion of the tubular body.

[0008] In various embodiments of this aspect, the balloon catheter can further include a radiopaque marker disposed at the distal portion of the tubular body to indicate a location of the sealed portion of the balloon. The distal portion of the balloon can extend through the radiopaque marker into the inner lumen of the tubular body to form the seal. The radiopaque marker includes a proximal end and a distal end, and the proximal end of the radiopaque marker is positionable within a predetermined distance of the sealed portion of the balloon.

[0009] In various embodiments of this aspect, the tubular body is provided with a plurality of channels in fluid communication with the interior of the balloon and the inner lumen of the tubular body. A density of the plurality of channels adjacent to the distal portion of the balloon can be greater than a density of the plurality of channels adjacent to the proximal portion of the balloon.

[0010] In various embodiments of this aspect, the tubular body has an outer diameter of 0.110 inches (8 French gauge) and an inner diameter ranging from 0.092 inches to 0.098 inches. In some embodiments, the tubular body has an outer diameter of 0.092 inches (7 French gauge) and an inner diameter ranging from 0.075 inches to 0.081 inches. In some embodiments, the tubular body has an outer diameter of 0.118 inches and an inner diameter ranging from 0.104 inches to 0.110 inches.

[0011] In some embodiments of this aspect, the sealed portion of the balloon defines an opening having a diameter ranging from 0.094 inches to 0.088 inches configured to provide a fluid-tight seal for an elongate member having an outer diameter ranging from 0.095 inches to 0.090 inches.

[0012] In some embodiments of this aspect, the inner surface of the tubular body includes polytetrafluoroethylene (PTFE) and the balloon is constructed from a material including styrene-isoprene block copolymer.

[0013] In another aspect, embodiments of the present disclosure feature a catheter assembly. The catheter assembly includes a balloon catheter having an inner lumen and an elongated member to be positioned in the inner lumen of the balloon catheter. The balloon catheter includes a tubular body having an outer surface and an inner surface defining the inner lumen of the balloon catheter, and a balloon circumferentially surrounding a distal end portion of the tubular body. The balloon includes a proximal end portion and a distal end portion each secured to the tubular body, and an expandable portion defining an interior in fluid communication with the inner lumen of the balloon catheter. The distal end portion of the balloon extends through the outer surface and the inner surface of the tubular body into the inner lumen of the balloon catheter forming a sealed portion circumferentially surrounding the inner surface of the tubular body. The elongated member is longitudinally movable in the inner lumen of the balloon catheter between a first position and a second position. At the first position, the elongated member is proximate to the sealed portion enabling fluid to pass through the sealed portion. At the second position, the elongated member is within the sealed portion and is substantially fluid-tightly sealed by the sealed portion forming an inflation lumen between the elongated member and the tubular body of the balloon catheter for introduction of fluid to inflate the balloon.

[0014] In various embodiments of this aspect, when the elongated member of the balloon catheter is at the second position, a distal end portion of the elongated member extends out of the inner lumen of the balloon catheter to perform a medical procedure. The elongated member can be an aspiration catheter configured to perform an aspiration thrombectomy, or a catheter used as a conduit to deliver a medical device or agent, such as a stent retriever configured to perform a mechanical thrombectomy, an embolic agent, or a guidewire.

[0015] In various embodiments of this aspect, the catheter assembly can further include a radiopaque marker disposed at the distal end portion of the tubular body to indicate a location of the sealed portion of the balloon. The radiopaque marker can include a proximal end and a distal end, where the proximal end of the radiopaque marker is proximate to the sealed portion of the balloon by a predetermined distance.

[0016] In various embodiments of this aspect, the tubular body of the balloon catheter is provided with a plurality of channels in fluid communication with the interior of the balloon and the inner lumen of the balloon catheter. A density of the plurality of channels adjacent to the distal end portion of the balloon can be greater than a density of the plurality of channels adjacent to the proximal end portion of the balloon.

[0017] In various embodiments of this aspect, the tubular body of the balloon catheter has an outer diameter of 0.092 inches and an inner diameter ranging from 0.075 inches to 0.081 inches.

[0018] In various embodiments of this aspect, the tubular body of the balloon catheter has an outer diameter of 0.110 inches (8 French device) and an inner diameter ranging from 0.092 inches to 0.098 inches.

[0019] In some embodiments, the tubular body has an outer diameter of 0.118 inches and an inner diameter ranging from 0.104 inches to 0.110 inches.

[0020] In various embodiments of this aspect, the sealed portion of the balloon defines an opening having a diameter ranging from 0.094 inches to 0.088 inches, the opening configured to provide a fluid-tight seal for an elongate member having an outer diameter ranging from 0.095 inches to 0.090 inches.

[0021] In another aspect, embodiments of the present disclosure feature a method. In the method, a catheter assembly is provided. The catheter assembly includes a first catheter and a second catheter positioned in an inner lumen of the first catheter. The first catheter includes a tubular body and a balloon circumferentially surrounding a distal end portion of the tubular body. The tubular body includes an outer surface and an inner surface defining an inner lumen of the first catheter. The balloon includes a proximal end portion, a distal end portion, and an expandable portion, the proximal end portion and the distal end portion each being secured to the tubular body, the expandable portion defining an interior in fluid communication with the inner lumen of the first catheter. The distal end portion of the balloon extends through the outer surface and the inner surface of the tubular body into the inner lumen of the first catheter, thereby forming a sealed portion circumferentially surrounding the inner surface of the tubular body. The second catheter is longitudinally movable in the inner lumen of the first catheter between a first position and a second position. At the first position, the second catheter is proximal to the sealed portion, thereby enabling fluid to pass through the sealed portion. At the second position, the second catheter is within the sealed portion and is substantially fluid-tightly sealed by the sealed portion, thereby forming an inflation lumen between the second catheter and the tubular body of the first catheter for introducing fluid to inflate the balloon. In the method, the second catheter is positioned at the first position. Fluid is introduced from a proximal end of the inner lumen of the first catheter and a proximal end of an inner lumen of the second catheter, respectively, and enabled to exit a distal end of the inner lumen of the first catheter and a distal end of the inner lumen of the second catheter. The second catheter is then positioned at the second position to form the inflation lumen. Fluid is introduced into the inflation lumen to inflate the balloon of the first catheter. The second catheter is proximally withdrawn to enable the fluid in the balloon to exit.

[0022] In various embodiments of this aspect, the tubular body of the first catheter is provided with a plurality of channels in fluid communication with the interior of the balloon and the inner lumen of the first catheter. The density of the plurality of channels adjacent to the distal end portion of the balloon is greater than the density of the plurality of channels adjacent to the proximal end portion of the balloon. The density of the plurality of channels adjacent to the distal end portion of the balloon can be at least twice the density of the plurality of channels adjacent to the proximal end portion of the balloon. Prior to the step of proximally withdrawing the second catheter, the catheter assembly can be held to orient the distal end portion of the balloon upwardly, and the balloon can be tapped to enable air bubbles to move upwardly to the distal end portion of the balloon.

[0023] This Summary is provided to introduce selected aspects and embodiments of the present disclosure in a simplified form, and is not intended to identify key features or essential characteristics of the claimed subject matter, nor is it intended to be used to determine the scope of the claimed subject matter. Selected aspects and embodiments are presented in this Summary to provide the reader with a brief overview of some forms the present disclosure can take, and are not intended to limit the scope of the present disclosure. Other aspects and embodiments of the present disclosure are described in the detailed description section of this document.

[0024] These and various other aspects, embodiments, features, and advantages of the present disclosure will be better understood and appreciated by reading the following detailed description, taken in conjunction with the accompanying drawings. BRIEF DESCRIPTION OF DRAWINGS

[0025] Figure 1 FIG. 1 illustrates a side partial cross-sectional view of an example balloon catheter, according to embodiments of the present disclosure.

[0026] Figure 2 FIG. 2 illustrates a top partial cutaway view of an example balloon catheter, according to embodiments of the present disclosure.

[0027] Figure 3 FIG. 3 illustrates an example catheter assembly, according to embodiments of the present disclosure. The example catheter assembly includes a balloon guide catheter and an aspiration catheter at a non-sealed location in the balloon guide catheter’s lumen.

[0028] Figure 4 FIG. 4 illustrates an example catheter assembly, according to embodiments of the present disclosure. The example catheter assembly includes a balloon guide catheter and an aspiration catheter at a sealed location in the balloon guide catheter’s lumen.

[0029] Figure 5 FIG. 5 is a flowchart illustrating a method, according to embodiments of the present disclosure.

[0030] Figures 6A to 6D FIG. 6 illustrates an example mandrel that can be used to manufacture a balloon catheter, according to embodiments of the present disclosure. DETAILED DESCRIPTION

[0031] With reference to the various figures, various embodiments of a balloon guide catheter or balloon catheter will be described. The figures are intended to facilitate describing the present disclosure and are not necessarily drawn to scale. Certain specific details of the disclosure can be set forth in the figures and the description in order to provide a thorough understanding of the present disclosure. It will be apparent, however, to one of ordinary skill in the art that some of these specific details can not be employed without departing from the scope of the embodiments of the present disclosure. In other instances, commonly known structures, materials, components, systems and / or operations have not been shown or described in detail in order to avoid unnecessarily obscuring the description of the embodiments of the present disclosure.

[0032] It should be noted that while some embodiments of the present disclosure are shown and described as balloon guide catheters in conjunction with aspiration thrombectomy, the balloon catheters, catheter assemblies, and methods described herein can be used for other procedures including interventional therapies, diagnostics, and imaging. The term "balloon guide catheter" can be used interchangeably with the term "balloon catheter."

[0033] Embodiments of the present disclosure provide a single lumen balloon catheter or balloon guide catheter. A seal is formed on an inner surface of the balloon catheter to fluid-tightly seal an elongated member, such as an aspiration catheter, positioned in the lumen of the balloon catheter. The dead space between the inner surface of the balloon catheter, the outer surface of the elongated member, and the seal forms an inflation lumen of the balloon. The seal located on the inner surface of the balloon catheter can be formed by the distal portion of the balloon extending through the wall of the balloon catheter into the lumen. The seal can be formed via hot compression of the balloon material through a hole drilled in the balloon catheter and / or a marker band at the distal end of the balloon catheter. A mandrel can be placed in the lumen of the balloon catheter to assist in the hot compression of the balloon material when forming the seal. The mandrel can have a reduced diameter notch or recessed area located directly below or facing the holes in the balloon catheter or marker band. The balloon material can be driven through the holes and into the recessed area of the mandrel by compression, thereby forming a circumferential seal on the inner surface of the balloon catheter.

[0034] The balloon catheters of the present disclosure enable the formation of an inflation lumen between the inner surface of the balloon catheter and the outer surface of an elongated member, such as an aspiration catheter, positioned in the lumen of the balloon catheter. By forming the inflation lumen in this way, a significant space savings can be achieved, thereby allowing for a much larger lumen size for a given outer diameter of the balloon catheter. In addition, the balloon catheters of the present disclosure enable the quick and easy removal of air from the inflation lumen and balloon when ready for use. As an example, when ready for use of the balloon catheter, an aspiration catheter can be inserted in the lumen of the balloon catheter and positioned immediately adjacent to the seal. The lumen of the balloon catheter can then be flushed with a fluid, such as saline or a mixture containing a contrast agent, until no air is observed to come out of the tip of the balloon catheter. The aspiration catheter can then be advanced through the seal to form an inflation lumen between the inner surface of the balloon catheter and the outer surface of the aspiration catheter in order to inflate and / or deflate the balloon.

[0035] Reference Figure 1 and Figure 2 An example balloon guide catheter or balloon catheter 100 according to embodiments of the present disclosure will now be described. Figure 1 is a side partial cross-sectional view of the balloon catheter 100, and Figure 2is a top partial cutaway view of balloon catheter 100. In general, balloon catheter 100 includes elongated tubular body 110, balloon 150 circumferentially surrounding a portion of tubular body 110, and seal 160 on the inner surface of tubular body 110. Tubular body 110 includes proximal end portion 112, distal end portion 114, and lumen 120 extending between proximal end portion 112 and distal end portion 114. Proximal end portion 112 of tubular body 110 can be coupled to hub 122, which can be provided with one or more ports, such as port 124a for connection to a source of fluid, such as saline or a mixture containing a contrast agent, and port 124b for receiving an elongated member, such as a suction catheter or guidewire. Distal end portion 114 of tubular body 110 can terminate in opening 126. Tubular body 110 has outer surface 116 and inner surface 118 defining lumen 120 of tubular body 110. Balloon 150 can be located at distal end portion 114 of tubular body 110. Alternatively, balloon 150 can be located at other locations, such as at an intermediate portion of the tubular body. Balloon 150 includes proximal end portion 152, distal end portion 154, and expandable portion 156 between proximal end portion 152 and distal end portion 154. Proximal end portion 152 and distal end portion 154 of balloon 150 can be secured to outer surface 116 of tubular body 110 via any suitable means, such as bonding. Expandable portion 156 of balloon 150 and a portion of outer surface 116 of tubular body 110 define interior 158. One or more conduits or channels 128 can be provided through the wall of tubular body 110 to enable fluid communication between interior 158 of balloon 150 and lumen 120 of tubular body 110. Distal end portion 154 of balloon 150 can extend through outer surface 116 and inner surface 118 of tubular body 110, or through the wall of tubular body 110, into lumen 120 of tubular body 110, to form a sealing portion or seal 160 circumferentially around inner surface 118 of tubular body 110. In some embodiments of the present disclosure, radiopaque marker 130 can be provided at distal end portion 114 of tubular body 110 and adjacent to distal end portion 154 of balloon 150. Radiopaque marker 130 can thus indicate the location of seal 160, enabling a user to determine, through the use of, for example, x-ray fluoroscopy, whether an elongated member, such as a suction catheter, located in lumen 120 of tubular body 110 is positioned within seal 160 or proximal to seal 160. As an example, a suction catheter can include a radiopaque marker at its distal end. By observing the positions of radiopaque marker 130 on balloon catheter 100 and the radiopaque marker on the suction catheter via, for example, x-ray fluoroscopy, a user can determine whether the suction catheter is positioned proximal to seal 160 (non-sealing position) or within seal 160 (sealing position), which will be described in greater detail below. Figures 3 to 4 A more detailed description of this will be provided.

[0036] Reference is made to Figure 1 and Figure 2 The tubular body 110 of the balloon catheter 100 can comprise a catheter constructed of a polymer, metal, or other suitable material. The tubular body 110 can comprise multiple layers. For example, the tubular body 110 can comprise an inner liner constructed of a lubricious or low-friction material to provide a smooth surface for advancing a device or object through the lumen 120. Suitable lubricious materials include, but are not limited to, polytetrafluoroethylene (PTFE), fluorinated ethylene propylene (FEP), and other suitable polymeric materials. The tubular body 110 can comprise a reinforcing layer configured to prevent the tubular body from kinking or flattening as it is navigated through tortuous vasculature. The reinforcing layer can be made of a metal such as stainless steel, nitinol, or from a polymer or any combination thereof. The reinforcing layer can have a structure of a coil or braid, or a flexible tubing with a laser cut pattern, or a hypotube such as a cut nitinol hypotube or a cut rigid polymer, or some other metallic tube. The reinforcing layer can extend from the proximal portion 112 to the distal portion 114 of the elongate tubular body 110, or substantially the entire length of the elongate tubular body 110. Alternatively, the reinforcing layer can extend partially along the elongate tubular body. For example, the reinforcing layer can be omitted in a portion of the proximal portion 112 of the elongate tubular body 110. The tubular body 110 can also comprise a jacket or sheath layer to provide mechanical integrity to the tubular body. The jacket layer can be constructed of a material such as a thermoplastic elastomer (TPE) (e.g., polyether block amide, thermoplastic polyurethane, polyethylene, nylon, etc.). The jacket layer can extend from the proximal portion 112 to the distal portion 114 of the elongate tubular body 110. Optionally, the tubular body 110 can comprise an outer coating. A thermoplastic polymeric material (e.g., ) can provide variable stiffness to the tubular body. A hydrophilic coating can be applied to the tube body and possibly the balloon to reduce friction when passing through an arterial vessel.

[0037] Reference is made to Figure 1 and Figure 2The tubular body 110 of the balloon catheter 100 can be provided with a plurality of channels or passages 128 to enable the interior 158 of the balloon 150 to be in fluid communication with the lumen 120 of the tubular body 110. The plurality of passages 128 enable fluid, such as saline or contrast, to be injected into or exit from the balloon 150 to effect inflation and / or deflation of the balloon 150. The passages 128 can be formed via any suitable means including laser cutting, etching, precision machining, etc. The passages 128 can be formed prior to securing the balloon 150 to the tubular body 110. According to embodiments of the present disclosure, the number or density of the passages 128 adjacent to the distal portion 154 of the balloon 150 is greater than the number or density of the passages 128 adjacent to the proximal portion 152 of the balloon 150. As an example, the number or density of the passages 128 adjacent to the distal portion 154 of the balloon 150 is about twice the number or density of the passages 128 adjacent to the proximal portion 152 of the balloon 150. As another example, the number or density of the passages 128 adjacent to the distal portion 154 of the balloon 150 is about three times the number or density of the passages 128 adjacent to the proximal portion 152 of the balloon 150. The difference in the number or density of the passages 128 adjacent to the distal portion 154 and the proximal portion 152 of the balloon 150 enables the balloon catheter 100 to be quickly and easily prepared for use, as will be described in further detail below. Figure 3 and Figure 4 This is further described below.

[0038] Referring to Figure 1 and Figure 2 The tubular body 110 of the balloon catheter 100 can include a radiopaque marker 130 to indicate the location of the seal or sealed portion 160 of the balloon 150. As an example, the radiopaque marker 130 can be located at the distal portion 154 of the balloon 150. The radiopaque marker 130 can have a proximal end 132, a distal end 134, and be provided with a plurality of holes 136 to enable the balloon material to be pressed through when forming the seal 160. The proximal end 132 of the radiopaque marker 130 can be traversed or straddle the seal 160 at a predetermined distance to provide an indication of the location of the seal 160 relative to the radiopaque marker 130, as will be described in further detail below. Figure 3 and Figure 4 This is further described below.

[0039] The radiopaque marker 130 can be constructed of a suitable radiopaque material that is visualizable via x-ray fluoroscopy. Radiopaque materials suitable for the distal marker include, but are not limited to, platinum, gold, tungsten, tantalum, barium, iodine, bismuth, etc., or alloys containing any of the above metals. The radiopaque marker 130 can be in the form of a coil that is wrapped around the tubular body 110. The radiopaque marker 130 can also be in the form of a band or coating on the tubular body.

[0040] The tubular body 110 of the balloon catheter can have a size and / or dimension suitable for medical applications. As an example, the tubular body 110 can include a distal end portion 114 having an outer diameter ranging from 0.092 inches to 0.118 inches and an inner diameter ranging from 0.075 inches to 0.110 inches. According to embodiments of the present disclosure, the distal end portion 114 of the tubular body 110 can have an outer diameter of 0.092 inches and an inner diameter ranging from 0.075 inches to 0.081 inches. According to alternative embodiments of the present disclosure, the distal end portion 114 of the tubular body 110 can have an outer diameter of 0.110 inches and an inner diameter ranging from 0.092 inches to 0.098 inches. According to alternative embodiments of the present disclosure, the distal end portion 114 of the tubular body 110 can have an outer diameter of 0.118 inches and an inner diameter ranging from 0.104 inches to 0.110 inches.

[0041] Referring to Figure 1 and Figure 2 , the balloon 150 can be constructed of an elastic and / or stretchable material such as a synthetic or naturally occurring polymeric material. Suitable materials for constructing the balloon 150 include, but are not limited to, rubber, latex, polyurethane, isoprene-based polymers or copolymers, silicone, and the like. As an example, is a styrene-isoprene block copolymer and can be used to construct the balloon 150. is commercially available from Mitsubishi Chemical of Japan.

[0042] Referring to Figure 1 and Figure 2 , the balloon 150 includes a proximal end portion 152 and a distal end portion 154 that can each be secured to the tubular body 110 via suitable means such as bonding. The distal end portion 154 of the balloon 150 can extend through the wall of the tubular body 110 into the lumen 120, thereby forming a seal portion or seal 160 that circumferentially surrounds the inner surface 118 of the tubular body 110. To form the seal 160, a plurality of through-holes can be drilled or provided in the wall of the tubular body 110, for example at the distal end portion 114. In embodiments where the tubular body 110 includes a radiopaque marker 130 at the distal end, a plurality of through-holes 136 can also be drilled or provided in the marker 130. A mandrel 170 having notched or recessed regions 172 Figures 6A to 6D ) can be placed in the lumen 120 of the tubular body 110. The recessed regions 172 of the mandrel 170 can be positioned to face the through-holes 136 in the tubular body 110 and the radiopaque marker 130. The balloon material can be pressed through the holes 136 by heat compression. The balloon material driven through the holes 136 can be received in the recessed regions 172 of the mandrel 170, thereby forming a seal portion or seal 160 that circumferentially surrounds the inner surface 118 of the tubular body 110.

[0043] Figures 6A to 6D An example mandrel 170 that can be used to form the seal 160 of the balloon catheter 100 is illustrated in accordance with embodiments of the present disclosure. As shown, the recessed region 172 of the mandrel 170 can be configured and / or dimensioned to form seals having various shapes and sizes. By way of example, the recessed region 172 of the mandrel 170 can have a triangular Figure 6A ), trapezoidal Figure 6B and Figure 6C ), square or rectangular Figure 6D ) or other suitable geometric cross-sectional shape to enable formation of seals having a corresponding shape. The reduced diameter or depth of the recess 172 of the mandrel 170 can be selected to form a seal 170 having an opening for receiving and providing a fluid-tight seal for an elongated member such as a suction catheter or guidewire.

[0044] Referring to Figures 3 to 4 An example catheter assembly 200 in accordance with embodiments of the present disclosure is now described. Generally, the catheter assembly 200 includes the balloon catheter 100 and an elongated member 210. The balloon catheter 100 includes the tubular body 110 having the lumen 120, the balloon 150 circumferentially surrounding the distal end portion of the tubular body 110, and the seal 160 formed on the inner surface of the tubular body 110. The elongated member 210 is longitudinally movable proximally and / or distally in the lumen 120 of the balloon catheter 110 and is receivable by and fluid-tightly sealed by the seal 160.

[0045] Referring to Figures 3 to 4 , the balloon catheter 100 can be used in conjunction with the above-described Figure 1 and Figure 2The balloon catheter described is the same or similar. For example, the balloon catheter 100 can include a tubular body 110 including a proximal end portion 112, a distal end portion 114, and a lumen 120 extending between the proximal end portion 112 and the distal end portion 114. The proximal end portion 112 of the tubular body 110 can be coupled to a hub 122, which can be provided with one or more ports for connection to a fluid source and / or to receive an elongated member 210 such as an aspiration catheter or a guidewire. The distal end portion 114 of the tubular body 110 can terminate in an opening 126. A balloon 150 can be located at the distal end portion 114 of the tubular body 110. The balloon 150 includes a proximal end portion 152, a distal end portion 154, and an expandable portion 156 between the proximal end portion 152 and the distal end portion 154. The proximal end portion 152 and the distal end portion 154 can be secured to the tubular body 110 via any suitable means such as bonding or thermal bonding. The expandable portion 156 of the balloon 150 defines an interior 158 with an outer surface 116 of the tubular body 110. One or more conduits or channels 128 can be provided through the wall of the tubular body 110 to enable the interior 158 to be in fluid communication with the lumen 120 of the tubular body 110. The distal end portion 154 of the balloon 150 can extend through the outer surface 116 and the inner surface 118 of the tubular body 110 or through the wall of the tubular body 110 into the lumen 120 to form a sealing portion or seal 160 that circumferentially surrounds the inner surface 118 of the tubular body 110. A radiopaque marker 130 can be provided at the distal end portion 114 of the tubular body 110 and adjacent to the distal end portion 154 of the balloon 150. Thus, the radiopaque marker 130 can indicate the location of the seal 160.

[0046] With reference to Figures 3 to 4 The elongated member 210 can be an aspiration catheter, a guidewire or a dilator, a selection catheter, or an elongated member carrying other devices for interventional therapy, diagnosis, imaging, etc. As an example, the elongated member 210 can be a catheter such as an aspiration catheter having a proximal end portion 212, a distal end portion 214, and a lumen 220 extending between the proximal end portion 212 and the distal end portion 214. The proximal end portion 212 of the elongated member 210 can be configured to be connected to a vacuum source. The distal end portion 214 of the elongated member 210 can terminate in an opening having a size and shape configured for aspiration thrombectomy. The aspiration catheter 210 can be constructed to include a plurality of layers (e.g., an inner layer, a reinforcing layer, and a jacket or sheath layer), and one or more outer coatings as described above in connection with the tubular body 110 of the balloon catheter 100. A radiopaque marker 222 can be provided at the distal end portion 214 of the aspiration catheter 210.

[0047] With reference to Figures 3 to 4 The elongated member 210 can be an aspiration catheter, a guidewire or a dilator, a selection catheter, or an elongated member carrying other devices for interventional therapy, diagnosis, imaging, etc. As an example, the elongated member 210 can be a catheter such as an aspiration catheter having a proximal end portion 212, a distal end portion 214, and a lumen 220 extending between the proximal end portion 212 and the distal end portion 214. The proximal end portion 212 of the elongated member 210 can be configured to be connected to a vacuum source. The distal end portion 214 of the elongated member 210 can terminate in an opening having a size and shape configured for aspiration thrombectomy. The aspiration catheter 210 can be constructed to include a plurality of layers (e.g., an inner layer, a reinforcing layer, and a jacket or sheath layer), and one or more outer coatings as described above in connection with the tubular body 110 of the balloon catheter 100. A radiopaque marker 222 can be provided at the distal end portion 214 of the aspiration catheter 210.Figure 3 ) and the sealing position or the second position ( Figure 4 It can move longitudinally between ( ). In such Figure 3 In the unsealed position shown, the distal end 214 of the elongated member 210 is positioned near the seal 160 of the balloon catheter 100. Therefore, fluid such as saline or contrast agent from the proximal end 212 of the aspiration catheter 210 and / or from the proximal end 112 of the balloon catheter 100 can flush away and exit the opening 126 of the balloon catheter 100 to remove air that may be present in the lumen of the balloon catheter 100. Figure 4 At the sealed position shown, the distal portion 214 or a portion of the elongated member 210 is received within the seal 160 and sealed fluid-impermeable. Thus, an inflatable cavity 230 is formed between the seal 160, the inner surface 118 of the tubular body 110 of the balloon catheter 100, and the outer surface 218 of the elongated member 210. A pressurized fluid, such as saline or a contrast agent, can be introduced from the proximal portion 112 of the tubular body 110 of the balloon catheter 100 into the inflatable cavity 230. The pressurized fluid can then enter the interior 158 of the balloon 150 via a conduit or channel 128 in the tubular body 110 to inflate the balloon 150. To deflate the balloon 150, the elongated member 210 can be moved to an unsealed position, for example, by retracting it proximally, allowing fluid in the balloon to exit via the channel 128, through the opening in the seal 160, and out of the opening of the balloon catheter 100.

[0048] Now for reference Figure 5 This section describes methods for using catheter assemblies in medical procedures such as thrombectomy. The catheter assembly can be a combination of the above. Figure 3 and Figure 4Any of the catheter assemblies described. The method 500 can begin at step 502, where a balloon catheter is prepared by removing air that can be present in the balloon and lumen of the balloon catheter. To remove or purge air from the balloon catheter, a dilator can be inserted into the lumen of the balloon catheter. Alternatively, a selection catheter or a suction catheter can be used in place of the dilator to purge air inside the balloon catheter prior to use. The dilator can be positioned such that its distal end is just proximal to the seal of the balloon catheter, i.e., the dilator is positioned at a non-sealing position relative to the balloon catheter. The balloon catheter and the dilator can then be connected to a source of fluid, such as saline or contrast media, respectively. The liquid is flushed through the lumen of the balloon catheter to purge air inside the lumen of the balloon catheter. The dilator can then be advanced into the seal to reach the sealing position. At the sealing position, an inflation lumen is formed between the dilator and the balloon catheter. Fluid can then be injected into the inflation lumen to inflate the balloon. To facilitate removal of air in the balloon, the tip of the balloon catheter can be held upward and tapped so that any air bubbles inside the balloon move upward to the distal end of the balloon. The dilator can then be withdrawn proximally to the non-sealing position to deflate the balloon. Because the number of conduits or channels in the balloon catheter adjacent to the distal end of the balloon is greater than the number of conduits or channels adjacent to the proximal end of the balloon, the fluid will exit the channels adjacent to the distal end of the balloon, causing a flow in the balloon from the proximal end to the distal end, thereby flushing out the air inside the balloon. The balloon can now be filled with contrast media in preparation for insertion into the patient's vascular system.

[0049] At step 504, the balloon catheter can be inserted into the patient's vascular system through an access vessel, such as the femoral artery or inferior vena cava in the groin region. The balloon catheter can be advanced to the treatment site in the vascular system, such as at the ICA, by any known technique, such as with the aid of a selection catheter and / or a guide wire.

[0050] At step 506, once the balloon catheter is in place near the treatment site, a suction catheter can be inserted into the balloon catheter. The suction catheter can be advanced and positioned such that the distal end of the suction catheter is just proximal to the seal of the balloon catheter, i.e., the suction catheter is positioned at a non-sealing position relative to the balloon catheter. Positioning the suction catheter to the non-sealing position can be facilitated by observing the radiopaque markers on the distal end of the suction catheter and in the balloon catheter via x-ray fluoroscopy.

[0051] At step 508, a contrast agent can be introduced into the catheter assembly to remove saline or any other fluid that can be left in the balloon catheter. The balloon catheter and the aspiration catheter can be connected to a source of contrast agent to flush the lumens until the contrast agent is clearly observed to exit the lumens of the balloon catheter. This step can be important because if saline or other fluid is left in the catheter lumens or balloon, the inflation of the balloon cannot be observed via x-ray fluoroscopy, increasing the risk of rupturing the balloon.

[0052] At step 510, the aspiration catheter can then be advanced distally to a sealing position to form a fluid-tight seal and inflation lumen between the aspiration catheter and the balloon catheter. Contrast agent can then be injected into the inflation lumen and balloon via a channel in the wall of the balloon catheter to inflate the balloon. The inflated balloon can now block blood flow. The aspiration catheter can be advanced distally to the treatment site to perform a medical procedure such as aspiration thrombectomy. Those of ordinary skill in the art understand that the aspiration catheter can reach the treatment site to perform the procedure before or after the balloon is inflated. After the medical procedure, the aspiration catheter and balloon catheter can be removed from the patient.

[0053] Various embodiments of a balloon guide catheter have been described with reference to the figures. It should be noted that aspects described in connection with a particular embodiment are not necessarily limited to that embodiment and can be practiced in any other embodiments. The figures are intended to illustrate embodiments and not to exhaustively describe or limit the scope of the disclosure. Alternative structures, components, and materials will readily be deemed feasible without departing from the principles of the claimed invention.

[0054] Unless specifically defined otherwise, all technical and scientific terms used herein have the meaning commonly understood by one of ordinary skill in the art in the field of the application. As used in the specification and the appended claims, the singular forms "a," "an" and "the" include plural references unless the context clearly dictates otherwise. The term "or" means "and / or" unless the context clearly dictates otherwise. The term "proximal" and its grammatical equivalents mean the location, direction, or orientation toward the side of the user or physician. The term "distal" and its grammatical equivalents mean the location, direction, or orientation away from the side of the user or physician. The terms "first" or "second" or the like can be used to distinguish one element from another element in describing various similar elements. It should be noted that the terms "first" and "second" as used herein include references to two or more of the same. Furthermore, the use of the terms "first" or "second" should not be interpreted to mean in any particular order, unless the context clearly dictates otherwise. In alternative embodiments, the order of execution of the method steps can be changed. One or more of the method steps can be skipped, and one or more optional steps can be included. All numerical values are provided for illustrative purposes and are assumed to be modified by the term "about" whether or not explicitly indicated. The term "about" generally refers to a range of numbers that a person of skill in the art would consider equivalent to the number recited, e.g., having the same function or result. The term "about" can include numbers that are rounded to the nearest significant figure. The recitation of numerical ranges by endpoints includes all numbers within that range.

[0055] Those skilled in the art will appreciate that various other modifications can be made. All such or other changes and modifications are contemplated by the inventors and are within the scope of the present application.

Claims

1. A balloon catheter, said balloon catheter comprising: A tubular body having an outer surface and an inner surface, the inner surface defining an internal cavity of the tubular body; as well as A balloon, circumferentially surrounding a portion of the tubular body, the balloon including a proximal portion, a distal portion, and an expandable portion, the proximal and distal portions each being fixed to the tubular body, the expandable portion defining an interior in fluid communication with the lumen of the tubular body, wherein... The distal portion of the balloon extends through the outer and inner surfaces into the lumen of the tubular body, thereby forming a circumferentially sealed portion surrounding the inner surface of the tubular body; The tubular body is provided with a plurality of channels in fluid communication with the interior of the balloon and the lumen of the tubular body, wherein the density of the plurality of channels adjacent to the distal portion of the balloon is greater than the density of the plurality of channels adjacent to the proximal portion of the balloon.

2. The balloon catheter according to claim 1, wherein, The balloon is positioned adjacent to the distal portion of the tubular body.

3. The balloon catheter according to claim 2, further comprising a radiopaque marker disposed at the distal portion of the tubular body, wherein, The radiopaque markings indicate the location of the sealing portion of the balloon.

4. The balloon catheter according to claim 3, wherein, The distal portion of the balloon extends through the radiopaque marker into the lumen of the tubular body.

5. The balloon catheter according to claim 4, wherein, The radiopaque marker includes a proximal end and a distal end, the proximal end of the radiopaque marker being close to the sealing portion of the balloon at a predetermined distance.

6. The balloon catheter according to claim 1, wherein, The tubular body has an outer diameter of 0.110 inches and an inner diameter ranging from 0.092 inches to 0.098 inches.

7. The balloon catheter according to claim 1, wherein, The tubular body has an outer diameter of 0.092 inches and an inner diameter ranging from 0.075 inches to 0.081 inches.

8. The balloon catheter according to claim 1, wherein, The sealing portion defines an opening with a diameter ranging from 0.087 inches to 0.091 inches, which is configured to provide a fluid-impermeable seal for elongated members with an outer diameter ranging from 0.092 inches to 0.096 inches.

9. The balloon catheter according to claim 1, wherein, The inner surface of the tubular body comprises polytetrafluoroethylene, and the balloon is constructed of a material comprising a styrene-isoprene block copolymer.

10. A catheter assembly comprising a balloon catheter having a lumen and an elongated member to be positioned within the lumen of the balloon catheter. in, The balloon catheter includes: A tubular body having an outer surface and an inner surface, the inner surface defining the lumen of the balloon catheter, and A balloon, circumferentially surrounding the distal portion of a tubular body, includes a proximal portion, a distal portion, and an expandable portion, the proximal and distal portions each being fixed to the tubular body. The expandable portion defines an interior in fluid communication with the lumen of the balloon catheter. The distal portion of the balloon extends through the outer and inner surfaces of the tubular body into the lumen of the balloon catheter, thereby forming a sealed portion circumferentially surrounding the inner surface of the tubular body. The tubular body is provided with a plurality of channels in fluid communication with the interior of the balloon and the lumen of the tubular body. The density of the plurality of channels adjacent to the distal portion of the balloon is greater than the density of the plurality of channels adjacent to the proximal portion of the balloon. The elongated member is longitudinally movable between a first position and a second position within the lumen of the balloon catheter. In the first position, the elongated member is close to the sealing portion, allowing fluid to pass through it. In the second position, the elongated member is located within the sealing portion and is substantially impermeable to fluid by it, thereby forming an inflatable lumen between the elongated member and the tubular body of the balloon catheter to introduce fluid and inflate the balloon.

11. The catheter assembly of claim 10, wherein, When the elongated member is in the second position, the distal portion of the elongated member extends outside the lumen of the balloon catheter to perform a medical procedure.

12. The catheter assembly of claim 10, wherein, The elongated member includes an aspiration catheter configured to perform aspiration thrombectomy.

13. The catheter assembly of claim 10, further comprising a radiopaque marker disposed at the distal portion of the tubular body, wherein, The radiopaque markings indicate the location of the sealing portion of the balloon.

14. The catheter assembly of claim 13, wherein, The distal portion of the balloon extends through the radiopaque marker.

15. The catheter assembly of claim 14, wherein, The radiopaque marker includes a proximal end and a distal end, the proximal end of the radiopaque marker being close to the sealing portion of the balloon at a predetermined distance.

16. The catheter assembly of claim 10, wherein, The tubular body has an outer diameter of 0.110 inches and an inner diameter ranging from 0.092 inches to 0.098 inches.

17. The catheter assembly of claim 10, wherein, The tubular body has an outer diameter of 0.092 inches and an inner diameter ranging from 0.075 inches to 0.081 inches.

18. The catheter assembly of claim 10, wherein, The sealing portion defines an opening with a diameter ranging from 0.087 inches to 0.091 inches, which is configured to provide a fluid-impermeable seal for elongated members with an outer diameter ranging from 0.092 inches to 0.096 inches.

19. A method of using a catheter assembly, the method comprising: A catheter assembly is provided, the catheter assembly including a first catheter having a lumen and a second catheter having a lumen, the second catheter being configured to be positioned within the lumen of the first catheter. The first catheter includes: A tubular body having an outer surface and an inner surface, the inner surface defining the lumen of the first catheter, and A balloon, circumferentially surrounding the distal portion of a tubular body, includes a proximal portion, a distal portion, and an expandable portion, the proximal and distal portions each being fixed to the tubular body. The expandable portion defines an interior in fluid communication with the lumen of a first catheter. The distal portion of the balloon extends through the outer and inner surfaces of the tubular body into the lumen of the first catheter, thereby forming a sealed portion circumferentially surrounding the inner surface of the tubular body. The tubular body is provided with a plurality of channels in fluid communication with the interior of the balloon and the lumen of the tubular body. The density of the plurality of channels adjacent to the distal portion of the balloon is greater than the density of the plurality of channels adjacent to the proximal portion of the balloon. The second catheter is longitudinally movable between a first position and a second position within the lumen of the first catheter. At the first position, the second catheter is close to the sealing portion, allowing fluid to pass through the sealing portion. At the second position, the second catheter is located within the sealing portion and is substantially fluid-impermeable to the sealing portion, thereby forming an expansion lumen between the second catheter and the tubular body of the first catheter to introduce fluid to inflate the balloon. Position the second conduit at the first location; Fluid is introduced from the proximal end of the lumen of the first catheter and from the proximal end of the lumen of the second catheter, such that the fluid is able to exit from the distal end of the lumen of the first catheter and the distal end of the lumen of the second catheter. Position the second catheter at the second location to form the expanded lumen; Fluid is introduced into the expansion lumen to inflate the balloon of the first catheter; and The second catheter is withdrawn proximally to allow the fluid in the balloon to exit.

20. The method of using the catheter assembly according to claim 19, further comprising: Before withdrawing the second catheter proximally, the catheter assembly is held to orient the distal portion of the balloon upward, and the balloon is tapped to allow the bubble to move upward to the distal portion of the balloon.

21. The method of using the catheter assembly according to claim 20, wherein, The density of the plurality of channels adjacent to the distal portion of the balloon is at least twice the density of the plurality of channels adjacent to the proximal portion of the balloon.

22. The method of using the catheter assembly according to claim 20, wherein, Introducing fluid into the expanded cavity includes introducing a contrast agent.

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