Balloon catheter to deflate trapped air in proximal direction

Abstract

The present invention is entitled "Balloon catheter for exhausting residual air in the proximal direction". The present invention relates to a balloon guide catheter system, which includes a balloon guide catheter having a catheter shaft, the catheter shaft including: (i) a main lumen; (ii) an inflation lumen; and (iii) an exhaust lumen. The terminal distal end of the inflation lumen and the terminal distal end of the exhaust lumen are in local fluid communication with each other under the balloon when the balloon is in a non-expanded state. The balloon is arranged around the distal region of the outer surface of the catheter shaft. The exhaust lumen is configured to clear residual air in the proximal direction and clear it out of the proximal region of the balloon guide catheter.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of U.S. Provisional Application No. 62 / 845,683, filed May 9, 2019; U.S. Provisional Application No. 62 / 845,699, filed May 9, 2019; U.S. Provisional Application No. 62 / 845,711, filed May 9, 2019; and U.S. Provisional Application No. 62 / 845,747, filed May 9, 2019, each of which is incorporated herein by reference in its entirety. Technical Field

[0003] The present invention relates to intravascular medical systems. In particular, the present invention relates to an improved balloon catheter for venting trapped air in a proximal direction. Background Art

[0004] Balloon catheters are widely used in conjunction with a variety of intravascular medical procedures or treatments. Typically, in order to inflate the balloon, a fluid or liquid under pressure is injected into the expansion lumen of the catheter. Before the balloon catheter is introduced into the body, the physician or interventionalist properly prepares the balloon catheter after a multi-step process of properly clearing residual air from the expansion lumen and balloon. Specifically, in the event of a balloon leak or rupture, clearing air from the expansion lumen prevents air embolism from entering the vascular system. In addition, residual air is also cleared from the balloon itself to ensure that the balloon is inflated with an expansion medium of the desired space, otherwise, the space of the expansion medium may be inaccurate due to the compression of the unknown space of the residual air in the balloon.

[0005] A common technique for clearing residual air from a balloon catheter prior to introduction into the body is to apply a vacuum or negative pressure to the proximal end of the expansion chamber using a syringe or vacuum, and to draw out as much air as possible proximally through the expansion chamber. The syringe vacuum is then closed via a valve (e.g., a three-way Luer valve), and the expansion chamber is opened under vacuum, allowing the expansion medium to be dispensed through it and into the balloon. During the injection of the expansion medium, the balloon is preferably held vertically in a downwardly tilted manner to facilitate air discharge, which allows the residual air in the catheter to rise toward the expansion port through the expansion medium. The expansion medium and some bubbles are withdrawn from the catheter, and additional expansion medium is injected again. It is not uncommon to have to repeat these steps multiple times to fully clear the catheter of residual air, which requires a lot of preparation time. For each iteration, these steps must be followed correctly.

[0006] In angiographic balloon catheter systems, the device is configured so that residual air from the inflation lumen and balloon is vented through the distal vents rather than proximally.

[0007] Because the preparation steps are numerous and time-consuming, physicians and interventionalists may be discouraged from fully using the device. Those physicians or interventionalists who use the device may inadvertently neglect to follow the proper preparation steps or fail to do so properly after introducing the balloon catheter into the body, resulting in potential health risks to the patient.

[0008]

[0006] It would therefore be desirable to design improved balloon catheters and methods of using such improved balloon catheters that evacuate trapped air in a proximal direction while reducing the steps associated therewith, thereby facilitating use of the device. Summary of the invention

[0009] One aspect of the present invention relates to an improved balloon catheter for venting trapped air in a proximal direction.

[0010] Another aspect of the present invention relates to a balloon guide catheter system including a balloon guide catheter. The balloon guide catheter has a catheter shaft having a proximal end and an opposite distal end; wherein the catheter shaft includes: (i) a main cavity axially defined to pass through the catheter shaft; (ii) an expansion cavity extending axially along the catheter shaft; the expansion cavity has a proximal end, an opposite terminal distal end; and (iii) an exhaust cavity extending axially along the catheter shaft, the exhaust cavity having a proximal end and an opposite terminal distal end. The terminal distal end of the expansion cavity and the terminal distal end of the exhaust cavity are in local fluid communication with each other below the balloon when the balloon is in a non-expanded state. In addition, the balloon guide catheter also includes a balloon arranged in a distal region around the outer surface of the catheter shaft, wherein the exhaust cavity is configured to remove residual air along the proximal side and remove it from the proximal region of the balloon guide catheter.

[0011] Another aspect of the present invention relates to a method of using a balloon guide catheter system as described in the preceding paragraphs. The method includes the following steps: dispensing an inflation medium through an inflation port of a hub connected to the proximal end of a catheter shaft and into an inflation lumen. Advancing the inflation medium distally through the inflation lumen pushed by the dispensed inflation medium causes proximally expelling residual air exiting the terminal distal end of the inflation lumen through an exhaust lumen. Expelling the residual air through a membrane that only allows residual air to pass therethrough and expelling the residual air from the proximal region of the balloon guide catheter. BRIEF DESCRIPTION OF THE DRAWINGS

[0012] The above and other features of the present invention will become more apparent from the following detailed description and accompanying drawings, in which examples of the present invention are illustrated, wherein like reference numerals refer to similar elements throughout the several views, and in which:

[0013] Figure 1A is a perspective view of a balloon catheter according to the present invention;

[0014] Figure 1B yes Figure 1A An enlarged view of the dotted square area 1B of the balloon portion of the balloon catheter, the view showing the mesh surface contour below the balloon, which promotes fluid communication between the inflation lumen and the exhaust lumen;

[0015] Figure 2A yes Figure 1A An alternative central portion configuration of a balloon catheter of (dashed square region II) wherein a one-way valve is attached to the exhaust port of the hub;

[0016] Figure 2B yes Figure 1A Yet another central configuration of a balloon catheter (dashed square region II) wherein the cleared lung acts as a vent in the hub;

[0017] FIG. 3A to FIG. 3D Shown along Figure 1B A radial cross-sectional view of different exemplary configurations of the exhaust lumen and the inflation lumen in the balloon catheter of the present invention along line III-III;

[0018] Figure 4A is a partial axial cross-sectional view of a distal end portion of a catheter of the present invention, wherein a balloon in a deflated state is stretched tight against an outer surface of a catheter shaft, wherein the terminal distal ends of respective inflation and exhaust lumens coincide within a single D-shaped partial fluid communication passage defined in an outer wall of the catheter shaft;

[0019] Figure 4B yes Figure 4A Top view of the catheter in;

[0020] Figure 4C It passes along line IV(C)–IV(C) Figure 4A A radial cross-sectional view of a local fluid communication channel;

[0021] FIG. 4D to FIG. 4F is an alternative exemplary radial cross-sectional view through a localized fluid communication passage, the view illustrating a different arrangement of the terminal distal ends of respective inflation and exhaust lumens coinciding within a single localized fluid communication passage defined in an outer wall of a catheter shaft;

[0022] Figure 4G is a top view of a distal end portion of a catheter of the present invention with the balloon in a deflated (non-inflated) state, wherein the terminal distal ends of the respective inflation and exhaust lumens coincide within a single localized fluid communication passageway defined in an outer wall of the catheter shaft and a surface contour disposed about a portion of an outer surface of the catheter shaft;

[0023] Figure 4His a top view of a distal end portion of a catheter of the present invention with the balloon in a deflated (non-inflated) state, wherein the terminal distal ends of the respective inflation and exhaust lumens are staggered relative to one another such that the terminal distal ends of the inflation lumens coincide with the first local fluid communication passageway and the terminal distal ends of the exhaust lumens coincide with the second local fluid communication passageway, the second local fluid communication passageway being axially spaced apart from the first local fluid communication passageway;

[0024] Fig. 4I is a partial top view of an axial cross-section of a catheter shaft without a balloon, wherein the partial fluid communication passage is a perforation (e.g., oval, circular, etc.), and the inflation lumen extends axially partially into the perforation;

[0025] Figure 4J is a partial top view of an axial cross-section of a catheter shaft without a balloon, wherein the partial fluid communication passage is a perforation (e.g., oval, circular, etc.), and the inflation lumen terminates at an interface with the perforation;

[0026] Figure 4K It passes along line IV(K)–IV(K) Fig. 4I a radial cross-sectional view of a local fluid communication channel of the catheter shaft, the view showing the inflation lumens coinciding within a single local fluid communication channel defined in an outer wall of the catheter shaft;

[0027] Figure 4L is a partial top view of an axial cross-section of a catheter shaft without a balloon, wherein the partial fluid communication passage is a perforation (e.g., oval, circular, etc.), and the respective terminal ends of the inflation lumen and the exhaust lumen terminate at an interface with the perforation;

[0028] Figure 5 is a perspective view of a balloon catheter of the present invention advanced to a target site within a body vessel;

[0029] Fig. 6A is a partial axial cross-sectional view of the distal end of an exemplary configuration of a balloon catheter of the present invention in a deflated state (non-expanded state); wherein the inflation lumen is concentrically arranged relative to the main / guidewire lumen, and the exhaust lumen is eccentrically arranged relative to the main / guidewire lumen;

[0030] Figure 6B yes Fig. 6A A radial cross-sectional view of the balloon catheter along line VI(B)-VI(B);

[0031] Figure 6C When the balloon is inflated Fig. 6A A partial axial cross-sectional view of the distal end of the balloon catheter;

[0032] Fig.6D The balloon was removed Fig. 6AA top view of a portion of a balloon catheter of , the view showing the arrangement of inlet and outlet ports in the catheter shaft;

[0033] Fig. 7A is a partial axial cross-sectional view of the distal end of another exemplary configuration of a balloon catheter of the present invention, wherein the balloon is in a deflated (non-inflated) state; wherein the inflation lumen is concentrically arranged relative to the main / guidewire lumen, and the exhaust lumen is eccentrically arranged relative to the main / guidewire lumen;

[0034] Figure 7B yes Fig. 7A A radial cross-sectional view of the balloon catheter along line VIIB-VIIB;

[0035] Figure 7C When the balloon is inflated Fig. 7A A partial axial cross-sectional view of the distal end of the balloon catheter;

[0036] Fig. 8A is a partial axial cross-sectional view of a distal end portion of yet another exemplary configuration of a balloon catheter of the present invention, wherein the balloon is in a deflated (non-inflated) state; wherein the inflation lumen is concentrically disposed relative to the main / guidewire lumen, and the exhaust lumen is eccentrically disposed relative to the main / guidewire lumen; and wherein the exhaust lumen is disposed within a portion of the inflation lumen and extends axially through the portion;

[0037] Figure 8B yes Fig. 8A A radial cross-sectional view of the balloon catheter along line VIII(B)-VIII(B);

[0038] Figure 8C When the balloon is inflated Fig. 8A A partial axial cross-sectional view of the distal end of the balloon catheter;

[0039] Fig. 9A is a partial axial cross-sectional view of a distal end portion of another exemplary configuration of a balloon catheter of the present invention, wherein the balloon is in a deflated (non-expanded) state; wherein the inflation lumen is concentrically arranged relative to the main / guide lumen, and the two exhaust lumens are eccentrically arranged relative to the main / guide lumen; and wherein the exhaust lumen intersects the inflation lumen radially inwardly of the exhaust lumen;

[0040] Fig. 9B yes Fig. 9A A radial cross-sectional view of the balloon catheter along line IX(B)-IX(B);

[0041] Fig. 9C When the balloon is inflated Fig. 9A A partial axial cross-sectional view of the distal end of the balloon catheter;

[0042] Fig. 10A is a perspective view of yet another aspect of a balloon guide catheter of the present invention without a balloon;

[0043] Fig. 10B yes Fig. 10A A radial cross-sectional view of the balloon guide catheter along the line X(B)-X(B);

[0044] Fig.11A When the valve is positioned in the open position during the period of clearing trapped air from the catheter and inflating the balloon Fig. 10A An axial cross-sectional view of the hub in FIG.

[0045] Fig. 11B is when the valve is positioned in the closed position during balloon deflation Fig. 10A Axial cross-sectional view of the hub in FIG. DETAILED DESCRIPTION

[0046] The terms "distal" or "proximal" are used in the following descriptions regarding positions or directions relative to a treating physician or medical interventionist. "Distal" or "distalward" is a position away from or in a direction away from a physician or interventionist. "Proximal" or "proximalward" or "proximally" is a position close to or in a direction toward a physician or medical interventionist. The terms "blockage," "clot," or "occlusion" are used interchangeably.

[0047] The balloon catheter of the present invention has multiple lumens that are arranged radially outward in the outer wall of the catheter relative to the main lumen that receives the guidewire passing therethrough. Specifically, there is at least one inflation lumen and at least one exhaust lumen, each of which extends axially from the hub toward the balloon in the outer wall of the catheter. The respective distal ends of the inflation lumen and the exhaust lumen are in local fluid communication with each other. The diameter of the main lumen of the device is large enough to serve as a catheter for guidewires (e.g., 0.014", 0.018", 0.035" and 0.038" guidewires) and auxiliary devices, such as: accommodating microcatheters, mechanical thrombectomy devices, diagnostic catheters, intermediate catheters / aspiration catheters during procedures. Preferably, the main lumen has a diameter of approximately 0.088".

[0048] Regardless of the specific configuration, the balloon catheter of the present invention clears, venting, trapped air from the balloon catheter in a proximal direction.

[0049] refer to Figure 1A 1 is a perspective view of a balloon catheter 100 of the present invention having a proximal end 105 and an opposite distal end 110. A hub 130 is secured proximal to the proximal end 105 of the balloon catheter 100. Figure 1AIn the first configuration shown, the hub 130 includes a main / guidewire port 140 for receiving a guidewire 90 or an auxiliary device therein. A separate inflation medium port 135 is also provided in the hub 130 for receiving an inflation medium from a syringe or other dispensing mechanism (the syringe 536 is in FIG. 1 ). Figure 5 The inflation medium (e.g., preferably 50% contrast saline solution) is introduced into the balloon catheter 100. Figure 1A In the illustrated construction, the hub 130 has no exhaust or vent. Instead, residual air is discharged or exhausted via an orifice defined in the outer surface of the exhaust cavity, which is near the proximal end of the catheter shaft but distal to the hub 130. When in the deflated (non-expanded) state, the balloon 115 fits tightly around the catheter shaft, which prohibits residual air from appearing between the deflated balloon and the catheter shaft. The distal terminal ends of both the expansion cavity 125 and the exhaust cavity 120 overlap below the balloon 115 and are arranged in close proximity to each other so that a relatively small amount of residual air in the expansion cavity is effectively communicated with the exhaust cavity. The advancing inflation medium flows into the balloon region along the path of least resistance, rather than retreating into the exhaust cavity.

[0050] Arranged axially or longitudinally through the balloon catheter 100 from the proximal end 105 are at least three separate, distinct, independent lumens, namely, a main / guidewire lumen 123, an exhaust lumen 120, and an inflation lumen 125. The exhaust lumen 120 and the inflation lumen 125 are arranged radially outwardly relative to the main / guidewire lumen 123. In addition, the main / guidewire lumen 123 extends from the proximal end 105 to the opposite distal end 110, while the respective terminal distal ends of the exhaust lumen 120 and the inflation lumen 125 terminate below (coinciding with) the balloon 115, from Figure 1B An enlarged partial view of the distal end of the catheter in FIG.

[0051] Preferably, near the terminating distal end of the vent lumen 120 is a microporous membrane or filter 121. The pores of the microporous membrane are sized to allow only gas (e.g., residual air) to pass therethrough, preventing the liquid (inflation medium) dispensed through the expansion lumen from permeating through the microporous membrane, which allows pressure within the expansion lumen to build and inflate the balloon as the space within the balloon fills with the inflation medium. Preferably, the microporous membrane is a grade (in terms of porosity and thickness) of sintered polytetrafluoroethylene (PTFE), e.g., expanded polytetrafluoroethylene (ePTFE), that allows air molecules to pass therethrough but acts as a barrier to larger, higher cohesive molecules (such as water and contrast agents). Such microporous membranes can also prevent air lock of the vent lumen and improper operation of the catheter.

[0052] Figure 2Ais an alternative configuration of hub 130' that includes a vent 137 through which residual air purged in the proximal direction exits balloon catheter 100, as well as the previously described inflation medium port 135 and main / guidewire port 140. Various auxiliary devices can be connected to vent 137. Figure 2A In one exemplary embodiment shown, a one-way valve 145 may be connected to the vent 137 to control the expulsion of trapped air from the balloon catheter. Figure 2B An alternative configuration is shown in FIG. 1 in which the vent 137 has been replaced by an inflatable lung, container or bladder 150 to store therein residual air that has been purged proximally from the balloon catheter.

[0053] In the operation of the balloon catheter of the present invention, an expansion medium (preferably 50% contrast saline solution) is introduced into the catheter using a syringe or other dispensing device attached to the expansion port of the hub. The expansion medium travels through the expansion cavity and enters the deflated balloon. The microporous membrane at the interface of the balloon and the exhaust cavity has holes that are sized to prohibit the expansion medium from passing therethrough, which only allows residual air to go out of the balloon and pass through the exhaust cavity. As the balloon is filled with the expansion medium, it expands. In line with the expansion of the balloon, the pressure inside the balloon increases, which causes the residual air in the balloon to be automatically discharged in the proximal direction through the exhaust cavity. At the hub, a sealable one-way exhaust valve can be used to control the residual air leaving the balloon catheter, and / or the purged residual air can be stored in an inflatable or expandable purging lung, thereby removing the residual air from the system and storing it in the hub outside the body by utilizing the fact that the residual air is compressible.

[0054] By way of non-limiting example, a plurality of configurations of one or more exhaust lumens and one or more inflation lumens are shown and described, each disposed radially outward from a main lumen in the balloon catheter 100. Additional configurations are possible and within the intended scope of the present invention, with a common feature among the different configurations being that residual air is exhausted from the catheter in a proximal direction rather than in a distal direction through the exhaust lumens. FIG. 3A to FIG. 3D Several exemplary designs of exhaust and inflation lumens and their arrangement relative to each other in a balloon catheter are shown. Figure 3A In the figure, the expansion lumen 125A has a curved radial cross section, the radius of curvature of which shares a common center (coaxial; concentric) with the radius of curvature of the main / guidewire lumen 123A. Two exhaust lumens 120A with circular radial cross sections are shown, which are radially displaced from each other as much as possible within the expansion lumen 125A, but any number of one or more exhaust lumens, and the position or spacing of the exhaust lumens 120A within the expansion lumen 125A, can be provided as desired. Figure 3BAn alternative construction is one in which each of the exhaust lumen 120B and the inflation lumen 125B respectively has a curved radial cross-section having a radius of curvature that shares a common center (coaxial; concentric) with the radius of curvature of the main / guidewire lumen 123B. Figure 3C Another configuration is shown in FIG. Figure 3A similar, Figure 3C The expansion lumen 125C in the embodiment has a curved radial cross-section whose radius of curvature shares a common center (coaxial; concentric) with the radius of curvature of the main / guidewire lumen 123C. However, in this particular design, the single exhaust lumen 120C is separate, distinct, and independent (with respect to the expansion lumen 125C). Figure 3A is the same as in the example above, but is not arranged in the expansion chamber). Figure 3D Another possible configuration is shown in FIG. Figure 3B The exhaust chamber 120D and the expansion chamber 125D are each Figure 3D The guidewire lumen 123A and the guidewire lumen 123A each have a curved radial cross-section, the radius of curvature of which shares a common center (coaxial; concentric) with the radius of curvature of the main / guidewire lumen 123A. Figure 3D and Figure 3B The difference is that the exhaust lumen 120D and the expansion lumen 125D are arranged approximately 180 degrees apart from each other in the radial direction (mirror images of each other). In another embodiment, the curved expansion lumen and exhaust lumen can be "D" shaped, or have a radius or curvature that is smaller / larger than the radius or curvature of the main / guidewire lumen. These are merely non-limiting illustrative examples of different arrangements of the main lumen, exhaust lumen, and expansion lumen in the catheter.

[0055] Figure 4A 4 is an exemplary partial axial cross-sectional view of the respective distal ends of the exhaust lumen 420 and the inflation lumen 425 that coincide with the balloon 415, wherein the balloon is shown in a deflated (non-expanded) state. A local fluid communication channel, depression or recess 475 is defined in the outer wall of the catheter shaft at any location that coincides with the balloon in the axial direction (e.g., a proximal region of the balloon, a middle region of the balloon, a distal region of the balloon), as long as the channel is located below / under the balloon 415 (coincides with the balloon 415). As shown in FIG. Figure 4B As can be clearly seen from the top view of FIG. 4 , the local fluid communication channel 475 can be D-shaped, however, other geometric shapes are contemplated (e.g., circular, elliptical, etc.). Fluid communication between the corresponding expansion lumen 425 and the terminating distal end of the exhaust / vent lumen 420 occurs within the local fluid communication channel 475. Figure 4B In the embodiment, the terminal distal ends of the corresponding exhaust lumens and the expansion lumens partially extend into the local fluid communication channel 475. Alternatively, the terminal distal ends of the corresponding exhaust lumens and the expansion lumens can coincide with the periphery or interface of the local communication channel 475. Figure 4C is along Figure 4A4(C)-IV(C) through the radial cross-section of the local fluid communication channel 475, which shows the side-by-side configuration of the terminal distal ends of the corresponding inflation lumen 425 and exhaust lumen 420 therein. When in the deflated (non-expanded) state, the balloon 415 is tightened around the outer surface of the catheter shaft, such as Figure 4A Thus, following the path of least resistance, residual air propelled through inflation lumen 425 by the pressurized injected inflation medium passes through exhaust lumen 420 and is expelled proximally from the catheter without inflating balloon 415 .

[0056] exist FIG. 4D to FIG. 4F An alternative arrangement or configuration of the distal ends of the corresponding exhaust and inflation lumens within the local fluid communication passage 475 radially outward from the main / guidewire lumen 423 is shown in different radial cross-sectional views. Figure 4D In the embodiment, the expansion chamber 425 and the exhaust chamber 420 are separately addressed, arranged in parallel, in physical contact with each other, and have equal inner and outer diameters. Figure 4E Again, a side-by-side arrangement is shown, where the two chambers are in physical contact with each other within the local fluid communication passage 475, however, both the inner and outer diameters of the chambers are different. Specifically, the outer diameter of the expansion chamber 425 is smaller than the outer diameter of the exhaust chamber 420, but the inner diameter of the expansion chamber 425 is larger than the inner diameter of the exhaust chamber 420. Preferably, the inner diameter of the expansion chamber is larger than the inner diameter of the exhaust chamber, as the exhaust chamber is only used to exhaust residual air. Figure 4F In the arrangement of , expansion chamber 425 and exhaust chamber 420 are again arranged side by side, in physical contact with each other within local fluid communication passage 475. The outer diameters of the expansion chamber and exhaust chamber are equal, while the inner diameter of expansion chamber 425 is greater than the inner diameter of exhaust chamber 420. Any combination or permutation of these arrangements of exhaust chambers and expansion chambers within the passageway and the sizes of the inner and outer diameters of each chamber are within the scope of the present invention.

[0057] Figure 4G 475. The present invention is a top view of a local distal portion of another configuration of a balloon catheter of the present invention having a single local fluid communication channel defined in a shaft in which the distal terminal ends of the respective exhaust and inflation lumens coincide within the single local fluid communication channel. Arranged around a portion of the outer periphery of the catheter shaft is a surface profile 480 that coincides with the local fluid communication channel 475 to facilitate fluid flow from the inflation lumen 425 to the exhaust lumen 420. Preferably, the surface profile 480 is a mesh made of a polymer, metal and / or other material that is wrapped around the outer surface of the catheter shaft. The balloon extends axially so as to completely cover or encapsulate the surface profile 480. The radial cross-sectional profile through the single local fluid communication channel 475 will be similar to Figure 4C As shown, but as needed, such as FIG. 4D to FIG. 4F Different arrangements than those shown are possible.

[0058] Figure 4H is a top view of yet another construction in which the terminating distal end of the expansion lumen 425 coincides with the first local fluid communication channel 475', while the terminating distal end of the exhaust lumen 420 coincides with the second local fluid communication channel 475", which is axially displaced away from the first local fluid communication channel 475'. In this arrangement, the surface profile 480 coincides with both the first local fluid communication channel 475' and the second local fluid communication channel 475". Again, the surface profile 480 promotes fluid communication between the expansion lumen and the exhaust lumen, which is particularly suitable for this arrangement in which the first local fluid communication channel 475' and the second local fluid communication channel 475" are axially displaced from each other along the catheter axis.

[0059] Fig. 4I and Figure 4J The top view of a portion of the catheter shaft (without the balloon) is shown showing a first localized fluid communication channel 475 as a perforation (e.g., oval, circular, etc.) defined in the outer surface of the catheter shaft. Fig. 4I In the embodiment, the terminal distal end of the expansion lumen 425 extends partially into the perforation, while in Figure 4J In the embodiment, the terminating distal end of the expansion lumen 425 is aligned with the interface of the perforation, that is, the terminating distal end of the expansion lumen does not extend into the perforation. Figure 4K The figure shows the line IV(K)-IV(K) passing through Fig. 4I A radial cross-sectional view of the first local fluid communication channel 475. Figure 4K The position of the inflation lumen 425 within the first local fluid communication channel 475 in the embodiment is to the left; however, any position within the first local fluid communication channel 475 may be selected as desired (e.g., in the middle of the channel, to the right of the channel, etc.). As previously mentioned, the terminal distal ends of the respective inflation lumens and exhaust lumens may be aligned (coincident) with the interface of a single perforation defined in the outer surface of the catheter shaft serving as a single local fluid communication channel, such as Figure 4L shown.

[0060] Figure 5 The balloon catheter 500 of the present invention is shown with the balloon 515 inflated at the target site in the artery 550. A syringe 536 or other injection device is connected to the Figure 5 An inflation port 535 is provided in the hub 530 to introduce an inflation medium (e.g., 50 / 50 contrast / saline solution) into the inflation lumen. A one-way or manual valve 545 is connected to the exhaust port 537 to control the removal of trapped air from the catheter. A main / guidewire port or opening 540 is also provided in the hub 530 for receiving a guidewire 90 therein.

[0061] Fig. 6A6 is a partial axial cross-sectional view of the distal end of another exemplary configuration of a balloon catheter 600 according to the present invention, wherein the balloon 615 is in a deflated (non-expanded) state. The expansion lumen 625 and the exhaust lumen 620 are two separate channels or passages extending axially side by side in the catheter shaft or body. The expansion lumen 625 terminates in at least one entry port, inlet opening or channel 630 ( Fig. 6A Two are shown in the figure) and are in fluid communication with the balloon 615 through which the inflation medium passes. The residual air is exhausted through the exhaust port, outlet opening or channel 635 and enters the exhaust cavity 620 defined in the catheter shaft. A reinforcing member can be set along a portion of the catheter shaft between the main cavity 623 and the inflation cavity 625 to enhance the rigidity of the distal region of the catheter to provide assistance during navigation of the blood vessel. The reinforcing member is preferably a metal wire, preferably a 0.001"-0.003" stainless steel wire, such as SS304 grade, which is made into a coil, a braid, or both. The reinforcing member is preferably embedded in a soft, flexible polymer material to prevent ovalization, dislocation and kinking of the catheter cavity.

[0062] exist Fig. 6A In the embodiment, the reinforcing member is a braid 640 disposed around the proximal region of the catheter shaft, followed distally by a coil 640' disposed along the distal region of the catheter shaft. Alternatively, the braid or coil may be used alone as the reinforcing member. In order to minimize friction when inserting the auxiliary device through the main lumen, an inner liner may be provided, preferably made of polytetrafluoroethylene (PTFE). Furthermore, in order to minimize kinking of the catheter in the axial direction during advancement through the vessel, a reinforcing inner sheath or sleeve 645 may be provided radially inwardly of the reinforcing member between the main lumen 623 and the expansion lumen 625. Preferably, the inlet opening 630 is disposed distally in the axial direction relative to the outlet opening 635. As shown in FIG. Figure 6B As shown in the radial cross-sectional view, the expansion chamber 625 is arranged concentrically (coaxially) relative to the main chamber 623, while the exhaust chamber 620 is arranged eccentrically relative to the main chamber. Figure 6C The catheter 600 is shown when the balloon 615 is in an expanded state, wherein the inlet opening 630 and the outlet opening 635 are respectively in fluid communication with the balloon 615. A top view of the catheter shaft without the balloon ( Fig.6D ) shows the arrangement of inlet openings 630 and outlet openings 635. Again, any number of one or more inlet ports and one or more outlet ports, as well as the arrangement of these ports along the catheter axis, may be varied as desired.

[0063] Fig. 7A FIG. 7 is a partial longitudinal cross-sectional view of the distal end of another exemplary configuration of a balloon catheter 700 according to the present invention. Again, the expansion lumen 725 is disposed radially outwardly from the main lumen 723 between the concentric axes (see FIG. 7 ). Figure 7B). The exhaust cavity 720 is formed by bonding, welding, mounting or attaching a thin polymer sheath 716 around the outer surface of the catheter shaft, forming a passage or space therebetween for use as the exhaust cavity 720. The expansion medium travels through the expansion cavity 725, exits from the inlet opening 730, and enters the balloon 715. The residual air travels along the outer surface of the catheter shaft into the outlet opening 735 and passes through the exhaust cavity 720 formed by the polymer sheath 716 mounted to the outer surface of the catheter shaft. The axial distance D between the inlet opening 730 and the outlet opening 735 is preferably minimized to help the communication between the expelled residual air and the exhaust cavity. The relatively large exhaust cavity formed by the relatively thin polymer sheath mounted to the outer surface of the outer shaft provides the following benefits: when the exhaust cavity is opened, the preparation time is reduced and the number of contractions is excellent. As with the previously described construction, a reinforcing structure, such as a braid 740, a coil 740' and / or an inner sheath 745, can be used to provide enhanced rigidity to the catheter.

[0064] Fig. 8A FIG. 8 is a partial axial cross-sectional view of the distal end of another exemplary configuration of a balloon catheter 800 according to the present invention. Fig. 6A The expansion lumen 825 is similar to the main lumen 823 in that the expansion lumen 825 is arranged concentrically with respect to the main lumen 823. However, the axially extending exhaust lumen 820 is a separate, isolated lumen that is completely disposed within the expansion lumen 825 between the inner and outer shafts of the catheter body, as shown in FIG. Figure 8B As shown. Again, the inlet opening 830 is in fluid communication with the balloon 815, while the outlet opening 835 is defined in the outer shaft, which provides direct communication between the balloon 815 and the exhaust lumen 820. The enlarged inner diameter is a benefit of this balloon catheter design, which can accommodate a wide range of auxiliary devices with larger outer diameters. As with all different configurations, a reinforcing structure, such as a braid 840, a coil 840' and / or an inner sheath 845, can be used to provide enhanced rigidity to the catheter.

[0065] Fig. 9A A partial axial cross-sectional view of the distal end of the catheter in FIG. 9 shows another exemplary configuration of a balloon catheter 900 according to the present invention. The inflation lumen 925 is arranged concentrically relative to the main lumen 923, while each of the two exhaust lumens 920 is arranged eccentrically relative to the main lumen 923. Fig. 6A , Figure 6B , Fig. 7A and Figure 7B ), the expansion chamber is disposed between an inner shaft and an outer shaft including a catheter body. Fig. 9A In the design, the exhaust cavity 920 is radially disposed within the inner catheter shaft between the main cavity 923 and the expansion cavity 925. Fig. 9BAs is apparent from the longitudinal cross-sectional view in FIG. , the exhaust chamber 920 intersects (intersects but is not in fluid communication with) the expansion chamber 925 . Fig. 9B is a radial cross-sectional view of the catheter along line IX(B)-IX(B), in which the two exhaust lumens 920 disposed within the inner shaft and radially inward from the expansion lumen 925 are clearly shown. Fig. 9C Shows the expansion state Fig. 9A of the catheter.

[0066] exist Figure 6B , Figure 7B , Figure 8B , Fig. 9B In each of the different exemplary configurations shown, the inflation lumen is concentric (coaxial) with respect to the main / guidewire lumen, while the exhaust lumen is eccentric with respect to the main / guidewire lumen.

[0067] Fig. 10A 1025 is a perspective view of another configuration of a balloon guide catheter of the present invention, which has a dual lumen (an expansion lumen 1025 and an exhaust lumen 1020) defined in the outer wall of the catheter shaft in addition to the main lumen 1023. The terminating distal ends of the respective expansion lumen 1025 and exhaust lumen 1020 coincide with a local fluid communication channel, recess or depression 1075. The local fluid communication channel 1075 is a position where the terminating distal ends of the respective expansion lumen and exhaust lumen are in fluid communication with each other. The local fluid communication channel 1075 is tautly or tightly assembled on the outer surface of the distal region of the catheter shaft covering the local fluid communication channel 1075 without being tightened or tightly assembled. Fig. 10A The balloon is shown in FIG. Fig. 10B 1025 and the exhaust cavity 1020 are arranged in parallel axially in a radial cross section, and the two cavities are arranged in the outer wall of the outer shaft from the radial outward of the main cavity 1023. Different arrangements of one or more expansion cavities and one or more exhaust cavities are possible, such as but not limited to FIG. 3A to FIG. 3D The proximal hub 1030 is connected to the proximal end of the balloon guide catheter. The hub 1030 includes a main / guidewire port 1040, an inflation port 1035, and an exhaust / vent port 1045. A valve 1095 is provided at the exhaust port 1045.

[0068] Fig.11A yes Fig. 10A 1030 in an axial cross-sectional view of the hub 1030 in which the three-way valve 1095 is oriented or positioned for inflating the balloon with an inflation medium (e.g., 50 / 50 contrast / saline solution) injected into the inflation port 1035 (via the Figure 5The inflation medium injected into the inflation port 1035 enters the inflation opening 1026 in the outer wall of the catheter shaft and fills the inflation lumen 1025. When the inflation medium reaches the local fluid communication passage, it enters the vent lumen 1020 and travels proximally through the vent lumen, exits the vent opening 1027 and enters the hub 1030. As the inflation medium is dispensed from the syringe under pressure and travels through the catheter, it is expelled proximally from the catheter, clearing residual air from the inflation lumen and balloon. A valve 1095 disposed distal to the vent port 1045 is provided at the distal end of the vent port 1045. Fig.11A The catheter is oriented or positioned in an open state, which allows residual air to flow therethrough, which then exits from the vent 1045 via the microporous membrane or filter 1021. The pores or openings of the microporous membrane or filter 1021 are sized to allow residual air to pass therethrough while inhibiting or preventing the passage of inflation medium therethrough. Once the residual air is completely purged from the catheter, any additional flow of inflation medium or increase in pressure applied by the syringe will result in inflation of the balloon. The flow rate of the inflation medium is maintained so that complete evacuation of the residual air occurs without sufficient pressure being established or generated in the catheter to initiate inflation of the balloon.

[0069] The local fluid communication channel 1075 below the balloon is designed to connect the two chambers (the exhaust chamber 1020 and the inflation chamber 1025), which allows residual air and inflation medium to flow out of the terminal distal end of the inflation chamber and into the terminal distal end of the exhaust chamber.

[0070] Deflation of the balloon is achieved by attaching a vacuum (e.g., a syringe) to the inflation port 1035, which creates a negative pressure within the catheter. When it is time to deflate the balloon, the valve 1095 is oriented to close flow to the vent port 1045. Upon application of a vacuum or suction (e.g., a syringe) attached to the inflation port 1035, which creates a negative pressure within the catheter, the inflation medium exhausted from the vent lumen is redirected into the bridging fluid communication channel 1090 to combine with the inflation medium exhausted through the inflation lumen and out of the inflation port 1035. This unique hub configuration, and particularly the orientation or positioning of the valve to close the vent port 1045 during deflation, provides for simultaneous removal of inflation medium through both the inflation lumen and the vent lumen when a vacuum is applied to the inflation port, thereby optimizing deflation of the balloon.

[0071] Preferably, the construction of the hub 1030 is optimized by minimizing the overall axial length of the hub 1030 in order to minimize manufacturing costs and to minimize the unusable length of the hub through which other catheters pass. It is also contemplated to replace the three-way manual valve 1095 with a spring-loaded valve or ball valve that automatically actuates upon the introduction of suction or vacuum applied to the expansion port 1035.

[0072] Compared to conventional devices, venting residual air from the balloon catheter of the present invention is less complicated and requires less time to complete. According to the present invention, air is automatically purged from the balloon catheter in a proximal direction. Specifically, the preparation of the balloon catheter of the present invention begins by passing an inflation medium through the inflation lumen, which coincides with the residual air purged, evacuated or expelled from the system in a proximal direction via the exhaust lumen, which reduces preparation time. In addition, since the residual air is exhausted in a proximal direction, the safety issues associated with purging air once the catheter is introduced into the body are eliminated.

[0073] The closed loop proximal venting system of the present invention has several advantages. Since the residual air is exhausted in the proximal direction, the interventionalist can prepare the device while the device is in the patient. Another benefit of the closed loop proximal design of the present invention is that the inflation medium automatically expels the residual air / gas through the microporous membrane and causes it to exit the venting cavity, while preventing the inflation medium from passing through the microporous membrane and causing the balloon to expand and stretch. Therefore, according to the present invention, the need for a valve or other mechanical device to inflate the balloon once the residual air is cleared is eliminated.

[0074] Therefore, although the basic novel features of the present invention as applied to its preferred embodiments have been shown, described and pointed out, it should be understood that various omissions, substitutions and changes in form and detail may be made to the illustrated system / device and its operation by those skilled in the art without departing from the spirit and scope of the present invention. For example, it is clearly intended that all combinations of those elements and / or steps that perform substantially the same functions in substantially the same manner to achieve the same results are within the scope of the present invention. It is also fully expected and conceivable that elements are replaced from one described embodiment to another. It should also be understood that the drawings may not be drawn to scale, but they are merely conceptual in nature. Therefore, it is intended to be limited only as indicated by the scope in the appended claims.

[0075] Each issued patent, pending patent application, publication, journal article, book, or any other reference cited herein is each incorporated by reference in its entirety.

Claims

1. A balloon guide catheter system, comprising: A balloon guide catheter, comprising: A catheter shaft having a proximal end and an opposite distal end; wherein the catheter shaft comprises: (i) a main lumen axially defined through the catheter shaft; (ii) an inflation lumen extending axially along the catheter shaft, the inflation lumen having a proximal end and an opposite terminating distal end; and (iii) an exhaust lumen extending axially along the catheter shaft, the exhaust lumen having a proximal end and an opposite terminating distal end; wherein the terminating distal end of the inflation lumen and the terminating distal end of the exhaust lumen are in local fluid communication with each other beneath the balloon when the balloon is in a non-expanded state; a balloon disposed about a distal region of an outer surface of the catheter shaft; and wherein the exhaust lumen is configured to purge trapped air in a proximal direction and away from a proximal region of the balloon guide catheter; and The catheter shaft has an outer surface defining a first local fluid communication passage beneath the balloon, wherein the terminal distal ends of the respective inflation and exhaust lumens are in local fluid communication with each other via the first local fluid communication passage.

2. A balloon guide catheter system according to claim 1, wherein the catheter shaft has a second local fluid communication channel defined in the outer surface, wherein the first local fluid communication channel and the second local fluid communication channel are separated from each other; wherein the terminating distal end of the inflation chamber coincides with the first local fluid communication channel, and the terminating distal end of the exhaust chamber coincides with the second local fluid communication channel. 3 . The balloon guide catheter system according to claim 1 , wherein the inflation lumen and the exhaust lumen are radially spaced apart from each other by a predetermined distance. The balloon guide catheter system according to claim 1 , wherein the exhaust lumen is disposed within the inflation lumen.

5. A balloon guide catheter system according to claim 2, wherein the area of ​​the outer surface of the catheter shaft that coincides with the first local fluid communication channel and the second local fluid communication channel has a surface contour to facilitate the flow of fluid between the inflation chamber and the exhaust chamber.

6. A balloon-guided catheter system according to claim 5, wherein the balloon completely encapsulates those areas of the outer surface of the catheter shaft having the surface contour.

7. A balloon guide catheter system according to claim 6, wherein the surface contour is an embossing of a mesh attached to the outer surface of the catheter shaft.

8. A balloon guide catheter system according to claim 1, wherein the exhaust lumen is arranged eccentrically relative to the main lumen.

9. The balloon guide catheter system of claim 8, wherein the exhaust lumen is disposed radially inward, radially outward, or within the inflation lumen.

10. The balloon guide catheter system according to claim 9 further includes a polymer sheath having a periphery; the periphery of the polymer sheath is mounted to the outer surface of the catheter shaft, thereby defining a space between the polymer sheath and the outer surface of the catheter body; the terminating distal end of the exhaust cavity is fluidically connected to the space.

11. The balloon guide catheter system of claim 9, wherein the exhaust lumen intersects the inflation lumen.

12. The balloon guide catheter system of claim 1, further comprising a hub connected to the proximal end of the catheter shaft; the hub comprising: an expansion port, the expansion port being in fluid communication with the expansion cavity; an exhaust port, the exhaust port being in fluid communication with the exhaust chamber; a bridging fluid communication passage connecting the expansion port and the exhaust port; a membrane disposed within the vent, the membrane having an opening defined therein, the opening being sized to allow only air to pass therethrough; a valve disposed in the vent distal to the membrane, the valve being capable of transitioning between: (i) an open state in which air is permitted to pass through the membrane and out of the vent; and (ii) a closed state in which expansion medium from the exhaust lumen is redirected through the bridging fluid communication passage and into the expansion lumen.

13. A method for using a balloon guide catheter system, the balloon guide catheter system comprising a balloon guide catheter having a catheter shaft, the catheter shaft having a proximal end and an opposite distal end; wherein the catheter shaft comprises: (i) a main lumen defined axially through the catheter shaft; (ii) an expansion lumen extending axially along the catheter shaft, the expansion lumen having a proximal end, an opposite terminating distal end, and being arranged radially outward and concentric with the main lumen; (iii) an exhaust lumen extending axially along the catheter shaft, the exhaust lumen having a proximal end and an opposite terminating distal end; wherein the terminating distal end of the expansion lumen and the terminating distal end of the exhaust lumen are in fluid communication with each other below the balloon when the balloon is in a non-expanded state; the balloon guide catheter also includes a balloon, which is arranged around a distal region of the outer surface of the catheter shaft; the exhaust lumen is configured to clear residual air in a proximal direction and clear it out of the proximal region of the balloon guide catheter; and the catheter shaft has an outer surface, the outer surface defining a first local fluid communication channel located below the balloon, and the terminating distal ends of the corresponding expansion lumen and the exhaust lumen are in local fluid communication with each other via the first local fluid communication channel; the method comprises the following steps: dispensing an inflation medium through an inflation port of a hub connected to the proximal end of the catheter shaft and into the inflation lumen; advancing the residual air pushed by the dispensed inflation medium distally through the inflation lumen; proximally exhausting the residual air exiting the terminal distal end of the inflation lumen through the exhaust lumen; and The trapped air is expelled through a membrane that only allows the trapped air to pass therethrough and is expelled from a proximal region of the balloon guide catheter.

14. The method of claim 13, wherein the step of discharging comprises the steps of: The residual air exiting from the terminating distal end of the inflation lumen is received in a local fluid communication passage covered by the balloon held taut on the outer surface of the catheter shaft when in a non-inflated state; wherein the terminating distal ends of the respective inflation and exhaust lumens are in fluid communication at the local fluid communication passage; and The residual air that exits is received into the terminating distal end of the exhaust lumen.

15. The method of claim 13, wherein the venting step includes positioning a valve in an open state to allow the trapped air to pass therethrough and out of the hub via an exhaust port.

16. The method according to claim 15, further comprising the steps of: After the residual air is completely purged from the balloon guide catheter, the balloon is inflated to an inflated state by continuing to dispense the inflation medium into the inflation lumen.

17. The method according to claim 15, further comprising the steps of: positioning the valve in a closed state, thereby closing the exhaust port of the hub; as well as applying a vacuum to the access port of the hub; Simultaneously, the distributed expansion medium is expelled proximally through the expansion chamber and the exhaust chamber; wherein the expansion medium expelled through the exhaust chamber is redirected by the valve in the closed state to travel through a bridging fluid communication channel connecting the exhaust chamber to the expansion chamber and out of the expansion port of the hub.

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