Method for preparing a balloon expandable catheter for cardiac and vascular interventional procedures

Abstract

A method for purging air from a balloon catheter. An inflation fluid is inserted into a balloon and an inflation chamber of a balloon catheter. The inflation chamber is in fluid communication with the balloon. The balloon catheter is positioned in an inverted orientation with its distal end disposed below its proximal end. The distal end of the balloon catheter contains a balloon. A vibration source is positioned in direct contact with an outer surface of the balloon catheter. The balloon catheter is vibrated by the vibration source. A vacuum is applied or drawn on the inflation chamber of the balloon catheter. The steps of vibrating the balloon catheter and applying the vacuum are performed simultaneously.

Description

Technical Field

[0001] The present disclosure relates to balloon catheters, and more particularly to methods of purging air from a balloon catheter prior to use in an interventional procedure. Background Art

[0002] Balloon catheters are commonly used in various medical procedures. For example, balloons are inflated during percutaneous transluminal coronary angioplasty (PTCA) to dilate narrowed blood vessels, and can also be used to deliver stents to support the lumen in an open position. Typically, balloon inflation is accomplished by injecting an inflation fluid under pressure into the inflation chamber of the balloon catheter. As the pressure of the inflation fluid in the balloon catheter increases during use, there is a possibility that the balloon may rupture due to excessive pressure of the inflation fluid. If such a rupture occurs, the inflation fluid in the catheter will enter the patient's bloodstream. Typically, the pressurized inflation fluid is saline or other physiologically inert solutions, which should not cause harm to the patient. However, if there is any air in the catheter, the balloon rupture may release air into the patient's blood vessels, which may form an air embolism. Therefore, the air in the balloon catheter must be purged before use to eliminate the risk of air embolism entering the blood vessel in the event of a system leak or balloon rupture. The air must also be pumped out of the balloon to achieve the desired inflation of the balloon using a specific volume of inflation fluid without considering the compression of the unknown volume of air in the balloon.

[0003] Because balloons are used in both arteries and veins, the inflation medium must be selected to avoid serious harm to the patient if the medium is accidentally released into the body. Radiopaque contrast media, either 100% or in water or saline solutions, is typically used to fill and purge all harmful gases from the balloon. As described above, air removal is critical not only to ensure patient safety, but also to prevent air blockages that could limit the amount of balloon inflation, thereby reducing the effectiveness of the procedure.

[0004] The common method of purging air from a balloon catheter before use involves creating a vacuum in the inflation chamber of the balloon catheter, usually in combination with a syringe for inflation fluid filling purposes. The inflation fluid is injected into the inflation chamber and the air is sucked into the syringe. In such procedures, the air that has been purged out of the catheter is collected in a syringe, which is removed from the catheter so that the air in the syringe can be discharged. These steps may have to be repeated multiple times to fully purge the air in the catheter, which requires a lot of labor and preparation time. Depending on the size of the balloon and therefore the volume of fluid and bubbles in the balloon catheter, the preparation time can be as long as thirty minutes. Long preparation time is particularly problematic for larger balloon catheters, such as balloon catheters used to implant replacement heart valves.

[0005] Therefore, it would be desirable to provide a method of purging air from a balloon catheter that requires less preparation time. Summary of the invention

[0006] Embodiments herein relate to methods for purging air from a balloon catheter. In one embodiment, an inflation fluid is inserted into a balloon and an inflation chamber of a balloon catheter. The inflation chamber is in fluid communication with the balloon. The balloon catheter is positioned in an inverted orientation with its distal end disposed below its proximal end. The distal end of the balloon catheter contains a balloon. A vibration source is positioned in direct contact with an outer surface of the balloon catheter. The balloon catheter is vibrated by the vibration source to move air within the balloon of the balloon catheter or air within the inflation chamber of the balloon catheter upward toward the proximal end of the balloon catheter.

[0007] In another embodiment, an inflation fluid is inserted into the balloon and inflation chamber of the balloon catheter. The inflation chamber is in fluid communication with the balloon. The balloon catheter is positioned in an inverted orientation with its distal end disposed below its proximal end. The distal end of the balloon catheter contains a balloon. A vibration source is positioned in direct contact with an outer surface of the balloon catheter. An inflation fluid is inserted into the balloon and inflation chamber of the balloon catheter. A vacuum is applied or drawn on the inflation chamber of the balloon catheter. While applying a vacuum to the inflation chamber of the balloon catheter, the balloon catheter is vibrated by the vibration source so that air in the balloon of the balloon catheter or air in the inflation chamber of the balloon catheter moves upward toward the proximal end of the balloon catheter through the inflation fluid.

[0008] In another embodiment, an inflation fluid is inserted into the balloon and inflation chamber of the balloon catheter. The inflation chamber is in fluid communication with the balloon. The balloon catheter is positioned in an inverted orientation with its distal end disposed below its proximal end. The distal end of the balloon catheter contains a balloon. A vibration source is positioned in direct contact with an outer surface of the balloon catheter. The balloon catheter is vibrated by the vibration source. A vacuum is applied or drawn on the inflation chamber of the balloon catheter. The steps of vibrating the balloon catheter and applying the vacuum are performed simultaneously. BRIEF DESCRIPTION OF THE DRAWINGS

[0009] The foregoing and other features and advantages of the present invention will become apparent from the following description of the embodiments of the present invention as shown in the accompanying drawings. The accompanying drawings, which are incorporated herein and form a part of this specification, are further used to explain the principles of the present invention and enable those skilled in the relevant art to make and use the present invention. The accompanying drawings are not drawn to scale.

[0010] Figure 1 is a side view of a balloon catheter according to an embodiment herein, wherein the balloon of the balloon catheter is in an expanded configuration.

[0011] Figure 1A It is along Figure 1 A cross-sectional view taken along line AA.

[0012] Figure 1B is a cross-sectional view of a balloon catheter according to an alternative embodiment of the present invention.

[0013] Figure 2 yes Figure 1 A side view of a balloon catheter and a stopcock, an inflator, and a vibration source, wherein the stopcock, the inflator, and the vibration source are accessories used in a method of purging air from a balloon catheter according to an embodiment of the present invention.

[0014] Figure 3 is a flow chart illustrating a method of purging air from a balloon catheter according to embodiments herein.

[0015] Figure 4 is a flow chart illustrating a method of purging air from a balloon catheter according to another embodiment herein.

[0016] Figure 5 is a flow chart illustrating a method of purging air from a balloon catheter according to another embodiment herein. DETAILED DESCRIPTION

[0017] Specific embodiments of the present invention are now described with reference to the accompanying drawings, wherein identical reference numerals indicate identical or functionally similar elements. In the following description, the terms "distal" and "proximal" are used with respect to a position or direction relative to a treatment clinician. "Distal" or "distally" is a position away from a clinician or in a direction away from a clinician. "Proximal" or "proximal" is a position close to a clinician or in a direction toward a clinician.

[0018] The following detailed description is merely exemplary in nature and is not intended to limit the invention or the application and use of the invention. Although the invention is described in the context of a balloon catheter for treating a heart valve, the invention may also be used in other valvular intracavitary sites that are not within the heart or in the context of treating blood vessels or other body passages, where deemed useful. In addition, the present invention is applicable to all balloon-expandable devices and any balloon catheter that can be purged of air before use. In other words, the present invention has wide applicability in all vascular interventional treatments involving balloon catheters. In addition, it is not intended to be bound by any explicit or implicit theory present in the aforementioned technical field, background technology, content of the invention, or the following specific embodiments.

[0019] Embodiments herein relate to methods for purging air in a balloon catheter prior to an interventional procedure. More specifically, embodiments herein relate to the use of a vibration source to rapidly remove bubbles or voids from a balloon catheter prior to use. The method described herein accelerates the removal of bubbles from a balloon catheter by applying a vibration source, significantly reducing the length of catheter preparation time. In order to facilitate the air removal process, the vibration source is in direct contact with certain external components of the catheter. This vibration action causes trapped bubbles to rise and leave the catheter through an inflation fluid column. This vibration action significantly reduces catheter preparation time. For example, in one embodiment, catheter preparation time can be reduced from approximately 15-30 minutes when purging and exhausting air from a relatively large balloon catheter using a conventional purging method to less than 2 minutes when using a vibration action to rapidly remove air for the same relatively large balloon catheter as described in the embodiments herein. The shortened catheter preparation time reduces physical strain on staff and also reduces the entire procedure time, thereby increasing the number of potential patients and revenue for a catheterization laboratory center.

[0020] Now turning to the attached figure, Figure 1 and 1A Describe exemplary balloon catheter 100, according to embodiments of this article, described balloon catheter can be purged of air before being used for interventional treatment procedure.In embodiments of this article, balloon catheter 100 can form the basis of prosthetic heart valve delivery system, stent delivery system, graft delivery system and / or drug delivery system.In other words, balloon catheter 100 can be used for delivering balloon expandable device (not shown), such as replacement heart valve, stent, graft, drug delivery device or other balloon expandable device.Alternately, balloon catheter 100 can be used for balloon angioplasty procedure.The purpose of angioplasty is to restore the sufficient blood flow of the affected artery, which can be achieved by inflating the balloon of the balloon catheter in the narrowed cavity of the artery to dilate the blood vessel.

[0021] The balloon catheter 100 includes a proximal portion 102 that extends out of the patient during clinical use and has a hub 104. As will be appreciated by one of ordinary skill in the art of balloon catheter design, the hub 104 includes a Luer fitting 105 or other type of fitting that can be connected to an inflation fluid source and can have another configuration or arrangement without departing from the scope of the present invention. The distal portion 106 of the balloon catheter 100 can be positioned at a target treatment site and includes an inflatable balloon 108 that is inflatable. Figure 1 The balloon 108 may be made of a biocompatible material, such as thermoplastic polyurethane (TPU) resin, styrene-ethylene-butadiene-styrene (SEBS), wait.

[0022] Reference along Figure 1The cross-sectional view taken along line AA Figure 1A , the balloon catheter 100 can have an over-the-wire (OTW) coaxial catheter configuration with an outer tubular assembly or shaft 110 and an inner tubular assembly or shaft 112. The outer shaft 110 has a proximal end 111 coupled to the hub 104 and a distal end 114 coupled to the proximal end of the balloon 108. The inner shaft 112 defines a guidewire lumen 116 that extends substantially the entire length of the catheter to accommodate a guidewire (not shown). The inner shaft 112 has a proximal end (at the distal end) coupled to the hub 104. Figure 1 104 and 108. The inner shaft 112 is coaxially extending within the outer shaft 110 such that an annular inflation lumen 120 is defined between the inner surface of the outer shaft 110 and the outer surface of the inner shaft 112. The inflation lumen 120 thus extends within the outer shaft 110 and into the inner volume of the balloon 108 to allow inflation fluid received through the inflation port of the luer fitting 105 of the hub 104 to be delivered to the balloon 108. The distal end of the balloon 108 is coupled to the inner shaft 112 distally of the distal end 114 of the outer shaft 110.

[0023] Other types of catheter structures may also be suitable for the present invention, such as but not limited to catheter shafts formed by extrusion of multi-lumen profiles. For example, in the cross-sectional view of a balloon catheter 100B according to an alternative embodiment, Figure 1B In the alternative catheter configuration is shown. Contrary to the inner catheter shaft and outer catheter shaft comprising coaxial, the balloon catheter 100B comprises a single catheter shaft 110B, which defines an inflation chamber 120B and a guidewire chamber 116B, which substantially extend the entire length of the catheter and are parallel to each other. Although depicted as a circle in cross section, one or more chambers of the catheter shaft 110B can have any suitable cross section, including, for example, a circle, an ellipse or a crescent. In addition, as will be appreciated by those of ordinary skill in the art, the balloon catheter 100B can have a quick-change configuration in which the guidewire chamber extends only along the distal portion of the catheter.

[0024] Regardless of the type of catheter construction, the catheter shaft can be formed of a polymeric material, non-exhaustive examples of which include polyethylene, polyethylene block amide (PEBA), polyamide, and / or combinations thereof. Optionally, the catheter shaft or certain portions thereof can be formed as a composite material having reinforcing materials incorporated into a polymer body to increase strength and / or flexibility. Suitable reinforcing layers include braids, mesh layers, embedded axial wires, embedded spiral or circumferential wires, and the like. For example, in one embodiment, at least the proximal portion of the outer shaft 110 or catheter shaft 110B can be formed of a reinforced polymeric tube.

[0025] Now go to Figure 2, the balloon catheter 100 is shown together with a stopcock 222, an inflator 224, and a vibration source 226. The stopcock 222, the inflator 224, and the vibration source 226 are accessories or tools used in a method of purging air from the balloon catheter 100 prior to use in an interventional procedure according to an embodiment of the present invention. As is known to those of ordinary skill in the art, the stopcock 222 can be a three-way stopcock and is configured to regulate the flow of an inflation fluid or gas therethrough. More specifically, as will be described in more detail herein, during the air purging method described herein, the stopcock 222 seals the balloon catheter 100 during the application of a vacuum by the inflator 224. The inflator 224 is configured to apply or draw a vacuum on the inflation lumen 120 of the balloon catheter 100 so as to purge air from the balloon 108 and the inflation lumen 120. In Figure 2 In the embodiment depicted in , the inflator 224 is a syringe. In addition, in addition to evacuating the vacuum, the inflator 224 is also configured to retain the inflation fluid therein to flush the inflation chamber 120. The vibration source 226 is a tool that is configured to directly contact one or more external regions of the balloon catheter 100 to expel air trapped in the balloon catheter 100 from the balloon catheter 100, as will be described in more detail herein. For exemplary purposes only, in one embodiment, the vibration source 226 can be a commercially available vortex mixer, such as the Vortex-Genie 2 available from Scientific Industries, Inc. of Bohemia, New York. In other embodiments, the vibration source 226 is a handheld tool that is configured to be held by a user and is configured to make direct physical contact with the outer surface of the balloon 108 and / or the outer surface of the outer shaft 110 or shaft 110B.

[0026] Now go to Figure 3 , a method for purging air in a balloon catheter 100 according to an embodiment of the present invention is shown. Figure 3 The method is preferably performed prior to an interventional procedure using in situ balloon catheter 100. This method is particularly advantageous for balloon catheters having larger balloons, such as, but not limited to, balloon catheters configured as delivery devices for replacement heart valves, because the method significantly reduces the length of catheter preparation time by applying the vibration source 226 to expedite the removal of bubbles / air from the balloon catheter as described above.

[0027] In step 330, the balloon catheter 100 is removed from its packaging. The stopcock 222 is attached to the inflation port at the proximal portion 102 of the balloon catheter 100. More specifically, the stopcock 222 is attached to the inflation port of the Luer fitting 105 of the hub 104 of the balloon catheter 100. As described above, the distal portion 106 of the balloon catheter 100 contains the balloon 108, and the inflation lumen 120 of the balloon catheter 100 is in fluid communication with the interior of the balloon 120. Although the balloon catheter 100 is described with respect to the Figure 3 However, one of ordinary skill in the art will understand that this is for illustration only and the method described herein for purging air in a balloon catheter can be used for balloon catheters of any configuration and size.

[0028] In step 332, the inflator 224 is prepared by at least partially filling the inflator 224 with an inflation fluid. In one embodiment, the inflator 224 is a syringe and the inflation fluid is a radiopaque contrast fluid, or a radiopaque contrast fluid mixed with saline or water. Other suitable biocompatible inflation fluids may be used.

[0029] In step 334, the inflator 224 is attached to the stopcock 222, which was previously attached to the inflation port of the Luer fitting 105 of the hub 104 of the balloon catheter 100 as described above, and the stopcock 222 is passed into the balloon catheter 100. When the stopcock 222 is passed into the balloon catheter 100, the inflator 224 is in fluid communication with the inflation lumen 120 of the balloon catheter 100, and the inflation lumen 120 of the balloon catheter 100 is sealed from the atmosphere. Alternatively, the inflator 224 can be attached to the stopcock 222, and then the combination of the inflator 224 and the stopcock 222 can be simultaneously attached to the inflation port at the proximal portion 102 of the balloon catheter 100.

[0030] In step 336, the inflation lumen 120 is at least partially filled with the inflation fluid from the inflator 224. To at least partially fill the inflation lumen 120 with the inflation fluid from the inflator, the inflation fluid may be injected or inserted into the inflation lumen 120 of the balloon 108 of the balloon catheter 100 through the inflator 224 by advancing the plunger of the inflator 224. In another embodiment, to at least partially fill the inflation lumen 120 with the inflation fluid from the inflator, a vacuum may be applied or pulled on the inflation lumen 120 of the balloon catheter 100 through the inflator 224, and then the vacuum may be removed by slowly releasing the plunger of the inflator 224 to a neutral position, thereby at least partially filling the inflation lumen 120 with the inflation fluid from the inflator. More specifically, the user may manually apply or pull a vacuum on the inflation lumen 120 of the balloon catheter 100 by “pulling negative” or retracting the plunger of the inflator 224. When the plunger of the inflator 224 is released to the neutral position, the inflation fluid within the inflator 224 is drawn into the balloon catheter 100 and the inflation lumen 120 is at least partially filled with the inflation fluid. In other words, the removal of the vacuum causes the inflation fluid from the inflator 224 to be pulled into the balloon catheter 100, so that the inflation lumen 120 and the balloon 108 are filled with the inflation fluid. The inflation fluid is drawn into the inflation lumen 120 and the balloon 108 due to the pressure change of the closed system.

[0031] In step 338, the balloon catheter 100 is inverted or positioned in an inverted orientation such that the distal portion 106 containing the balloon 108 is oriented to be below or facing downward relative to the proximal portion 102 of the balloon catheter and the inflator 224 coupled thereto. In one embodiment, the balloon catheter 100 is positioned in a vertical orientation with its distal end containing the balloon 108 disposed vertically below the hub 104 and the inflator 224. However, the balloon catheter 100 need not be oriented vertically; the balloon catheter 100 may be oriented at an angle so long as the distal portion 106 containing the balloon 108 of the balloon catheter is oriented to be below or facing downward relative to the inflator 224. As will be described in more detail herein, positioning the inflator 224 above the balloon catheter 100 allows bubbles to ascend / rise through the column of inflation fluid in the inflation lumen 120 and to be expelled from the balloon catheter 100 through the inflator 224.

[0032] In step 340, the vibration source 226 is positioned to be in direct contact with the outer surface of the balloon catheter. In one embodiment, the vibration source 226 is a handheld tool configured to be held by a user. In one embodiment, the vibration source 226 includes an outer surface configured to be held by a user and includes an inner surface (not shown) configured to be in direct physical contact with the outer surface of the balloon 108 and / or the outer surface of the outer shaft 110. For example, the inner surface of the vibration source 226 can have a shape corresponding to the outer surface of the balloon 108 and / or the outer surface of the outer shaft 110.

[0033] In step 342, a vacuum is applied or pulled on the inflation lumen 120 of the balloon catheter 100 by the inflator 224. More specifically, the user may manually apply or pull a vacuum on the inflation lumen 120 of the balloon catheter 100 by "negatively pulling" or retracting the plunger of the inflator 224. Applying a vacuum causes air to be evacuated from the inflation lumen 120 of the balloon catheter 100. In other words, any remaining air or gas is purged from the inflation lumen 120 of the balloon catheter 100, and the pressure within the inflation lumen 120 of the balloon catheter 100 is reduced to a pressure below atmospheric pressure. In one embodiment, any remaining air or gas is purged from the inflation lumen 120 of the balloon catheter 100 until the pressure in the inflation lumen 120 is between 1 PSIA and 12 PSIA. During step 342 , the stopcock remains in its previous position (“open to balloon catheter 100 ”) and thereby seals balloon catheter 100 , while inflator 224 draws a vacuum on inflation lumen 120 of balloon catheter 110 .

[0034] In step 344, a vacuum is maintained on the inflation lumen 120 of the balloon catheter 100 by the inflator 224 while vibrations are applied to the balloon catheter 100 by the vibration source 226. The balloon catheter 100 is vibrated by the vibration source 226 while a vacuum is applied to the inflation lumen 120 of the balloon catheter 100 to move air within the balloon 108 of the balloon catheter 100 or air within the inflation lumen 120 of the balloon catheter 100 upward toward the proximal end of the balloon catheter 100 and the inflator 224. In other words, vibrating the balloon catheter 100 with the vibration source 226 causes any air or bubbles trapped in the balloon catheter 100 to rise outside the balloon 108 and the inflation lumen 120 until such air or bubbles exit the balloon catheter 100 and enter the inflator 224. When air or bubbles exit the balloon catheter 100 and enter the inflator 224, the user can visually see such air or bubbles in the inflator 224. A vacuum is maintained on the inflation lumen 120 of the balloon catheter 100 by the inflator 224 while vibrations are applied to the balloon catheter 100 until no new air or bubbles are seen to enter the inflator 224. For example, in one embodiment, the vacuum is maintained on the inflation lumen and the vibrations are simultaneously applied to the balloon catheter for 15 to 45 seconds. In one embodiment, the vacuum is maintained on the inflation lumen and the vibrations are simultaneously applied to the balloon catheter for approximately 30 seconds. Although vibrations are described herein as being applied during step 344, vibrations may also be applied during prior method steps. For example, vibrations may begin immediately after the vibration source 226 is placed in direct contact with the balloon catheter 100, or vibrations may begin before or simultaneously with step 342 when a vacuum is initially drawn or applied to the inflation lumen 120.

[0035] In one embodiment, during step 344, the vibration source 226 moves or slides along the outer surface of the balloon catheter 100 while vibrating the balloon catheter. For example, the vibration source 226 can initially be placed in direct physical contact with the outer surface of the balloon 108. As air or bubbles trapped in the balloon 108 rise through the inflation lumen 120, the user can move or slide the vibration source 226 onto the outer surface of the outer shaft 110 along with the movement of air within the balloon catheter 100. It is preferred to maintain direct contact between the outer surface of the balloon catheter 100 and the vibration source 226 while moving the vibration source 226.

[0036] In step 346, after no new air or bubbles are seen entering the inflator 224, the vacuum is removed from the inflation lumen 120 of the balloon catheter 100 by slowly releasing the plunger of the inflator 224 to a neutral position. Vibrations may continue to be applied by the vibration source 226 during this step, or they may be removed.

[0037] In step 348, the stopcock 222 leading into the balloon catheter 100 is closed. When the stopcock 222 is close to the balloon catheter 100, the inflator 224 is no longer in fluid communication with the inflation lumen 120 of the balloon catheter 100. The inflation lumen 120 of the balloon catheter 100 remains sealed relative to the atmosphere. At this step of the method, it is no longer necessary to apply vibrations to the balloon catheter 100 via the vibration source 226.

[0038] In step 350, after closing the stopcock 222 leading to the balloon catheter, the inflator 224 is separated from the stopcock 222 and purged by advancing the plunger to force air out of the syringe. Any air accumulated in the inflator 224 during step 344 is released or purged from the inflator 224.

[0039] In step 352, the operator decides or determines whether the air in the balloon catheter 100 is sufficiently purged. For example, the operator may visually inspect the balloon catheter 100 to determine whether any additional bubbles are still present within the balloon catheter 100. The operator may also determine whether the air in the balloon catheter 100 is sufficiently purged based on observation of the rate and size of air or bubbles entering the inflator 224 during step 344. If the rate of air or bubbles is relatively slow and / or the size of the air or bubbles is relatively small, the operator may determine that the air in the balloon catheter 100 is sufficiently purged. If the operator determines that the air in the balloon catheter 100 is sufficiently purged, the balloon catheter preparation method is considered complete at step 354. However, if the operator determines that the air in the balloon catheter 100 has not been adequately purged, then the inflator 224 is reconnected to the stopcock 222 and the above-described steps of applying or pulling a vacuum on the inflation lumen 120 of the balloon catheter 100 using the inflator while vibrating the balloon catheter 100 with the vibration source 226 are repeated until the air or bubbles are completely purged out of the balloon 108 and the inflation lumen 120. More specifically, steps 334, 336, 338, 340, 342, 344, 346, 348, and 350 are repeated as necessary until all air is removed from the balloon catheter.

[0040] Figure 4 Another embodiment of the present invention is shown in which the inflation lumen 120 can be repeatedly flushed as needed, vibrated while applying vacuum to the balloon catheter, and then the inflator is separated to purge any trapped air in the inflator. Figure 3 method, Figure 4The method is preferably performed prior to an interventional procedure using in situ balloon catheter 100. This method is particularly advantageous for balloon catheters having larger balloons, such as, but not limited to, balloon catheters configured as delivery devices for replacement heart valves, because the method significantly reduces the length of catheter preparation time by applying the vibration source 226 to expedite the removal of bubbles / air from the balloon catheter as described above.

[0041] In step 430, similar to step 330, the balloon catheter 100 is removed from its packaging. The stopcock 222 is attached to the inflation port at the proximal portion 102 of the balloon catheter 100. More specifically, the stopcock 222 is attached to the inflation port of the Luer fitting 105 of the hub 104 of the balloon catheter 100. As described above, the distal portion 106 of the balloon catheter 100 contains the balloon 108, and the inflation lumen 120 of the balloon catheter 100 is in fluid communication with the interior of the balloon 120. Although the balloon catheter 100 is described with respect to the inflation port 108, the inflation lumen 120 of the balloon catheter 100 is in fluid communication with the interior of the balloon 120. Figure 4 However, one of ordinary skill in the art will understand that this is for illustration only and the method described herein for purging air in a balloon catheter can be used for balloon catheters of any configuration and size.

[0042] In step 432, similar to step 332, the inflator 224 is prepared by at least partially filling the inflator 224 with an inflation fluid. In one embodiment, the inflator 224 is a syringe and the inflation fluid is a radiopaque contrast fluid, or a radiopaque contrast fluid mixed with saline or water. Other suitable biocompatible inflation fluids may be used.

[0043] In step 434, similar to step 334, the inflator 224 is attached to the stopcock 222, which was previously attached to the inflation port of the Luer fitting 105 of the hub 104 of the balloon catheter 100 as described above, and the stopcock 222 is passed into the balloon catheter 100. When the stopcock 222 is passed into the balloon catheter 100, the inflator 224 is in fluid communication with the inflation lumen 120 of the balloon catheter 100, and the inflation lumen 120 of the balloon catheter 100 is sealed relative to the atmosphere. Alternatively, the inflator 224 can be attached to the stopcock 222, and then the combination of the inflator 224 and the stopcock 222 can be simultaneously attached to the inflation port at the proximal portion 102 of the balloon catheter 100.

[0044] In step 436, similar to step 336, the inflation lumen 120 is at least partially filled with the inflation fluid from the inflator 224. To at least partially fill the inflation lumen 120 with the inflation fluid from the inflator, the inflation fluid may be injected or inserted into the inflation lumen 120 of the balloon 108 of the balloon catheter 100 through the inflator 224 by advancing the plunger of the inflator 224. In another embodiment, to at least partially fill the inflation lumen 120 with the inflation fluid from the inflator, a vacuum may be applied or pulled on the inflation lumen 120 of the balloon catheter 100 through the inflator 224, and then the vacuum may be removed by slowly releasing the plunger of the inflator 224 to a neutral position, thereby at least partially filling the inflation lumen 120 with the inflation fluid from the inflator. More specifically, the user may manually apply or pull a vacuum on the inflation lumen 120 of the balloon catheter 100 by “negatively pulling” or retracting the plunger of the inflator 224. When the plunger of the inflator 224 is released to the neutral position, the inflation fluid within the inflator 224 is drawn into the balloon catheter 100 and the inflation lumen 120 is at least partially filled with the inflation fluid. In other words, the removal of the vacuum causes the inflation fluid from the inflator 224 to be pulled into the balloon catheter 100, so that the inflation lumen 120 and the balloon 108 are filled with the inflation fluid. The inflation fluid is drawn into the inflation lumen 120 and the balloon 108 due to the pressure change of the closed system.

[0045] In step 438, similar to step 338, the balloon catheter 100 is inverted or positioned in an inverted orientation such that the distal portion 106 containing the balloon 108 is oriented to be below or facing downward relative to the proximal portion 102 of the balloon catheter and the inflator 224 coupled thereto. In one embodiment, the balloon catheter 100 is positioned in a vertical orientation with its distal end containing the balloon 108 disposed vertically below the hub 104 and the inflator 224. However, the balloon catheter 100 need not be oriented vertically; the balloon catheter 100 may be oriented at an angle as long as the distal portion 106 containing the balloon 108 of the balloon catheter is oriented to be below or facing downward relative to the inflator 224. As will be described in more detail herein, positioning the inflator 224 above the balloon catheter 100 allows bubbles to ascend / rise through the column of inflation fluid in the inflation lumen 120 and to be expelled from the balloon catheter 100 through the inflator 224.

[0046] In step 440, similar to step 340, vibration source 226 is positioned to directly contact the outer surface of the balloon catheter. In one embodiment, vibration source 226 is a hand-held tool configured to be held by a user. In one embodiment, vibration source 226 includes an outer surface configured to be held by a user and includes an inner surface (not shown) configured to be in direct physical contact with the outer surface of balloon 108 and / or the outer surface of outer shaft 110. For example, the inner surface of vibration source 226 can have a shape corresponding to the outer surface of balloon 108 and / or the outer surface of outer shaft 110.

[0047] In step 442, similar to step 342, a vacuum is applied or pulled on the inflation lumen 120 of the balloon catheter 100 by the inflator 224. More specifically, the user may manually apply or pull a vacuum on the inflation lumen 120 of the balloon catheter 100 by "negatively pulling" or retracting the plunger of the inflator 224. Applying a vacuum causes air to be evacuated from the inflation lumen 120 of the balloon catheter 100. In other words, any remaining air or gas is purged from the inflation lumen 120 of the balloon catheter 100, and the pressure within the inflation lumen 120 of the balloon catheter 100 is reduced to a pressure below atmospheric pressure. In one embodiment, any remaining air or gas is purged from the inflation lumen 120 of the balloon catheter 100 until the pressure in the inflation lumen 120 is between 1 PSIA and 12 PSIA. During step 442 , the stopcock 222 remains in its previous position (“open to balloon catheter 100 ”) and thereby seals the balloon catheter 100 , while the inflator 224 draws a vacuum on the inflation lumen 120 of the balloon catheter 110 .

[0048] In step 444, similar to step 344, a vacuum is maintained on the inflation lumen 120 of the balloon catheter 100 by the inflator 224 while vibrations are applied to the balloon catheter 100 by the vibration source 226. The balloon catheter 100 is vibrated by the vibration source 226 while a vacuum is applied to the inflation lumen 120 of the balloon catheter 100 so that air within the balloon 108 of the balloon catheter 100 or air within the inflation lumen 120 of the balloon catheter 100 moves upward through the column of inflation fluid toward the proximal end of the balloon catheter 100 and the inflator 224. In other words, vibrating the balloon catheter 100 with the vibration source 226 causes any air or bubbles trapped in the balloon catheter 100 to rise outside the balloon 108 and the inflation lumen 120 until such air or bubbles leave the balloon catheter 100 and enter the inflator 224. When air or bubbles leave the balloon catheter 100 and enter the inflator 224, the user can visually see such air or bubbles in the inflator 224. A vacuum is maintained on the inflation lumen 120 of the balloon catheter 100 through the inflator 224 while vibration is applied to the balloon catheter 100 until no new air or bubbles are seen to enter the inflator 224. For example, in one embodiment, the vacuum is maintained on the inflation lumen and the vibration is applied to the balloon catheter simultaneously for 15 to 45 seconds. In one embodiment, the vacuum is maintained on the inflation lumen and the vibration is applied to the balloon catheter simultaneously for approximately 30 seconds. Although vibration is described herein as being applied during step 442, vibration may also be applied during previous method steps. For example, vibration may begin immediately after the vibration source 226 is placed in direct contact with the balloon catheter 100, or vibration may begin before or simultaneously with step 442 when a vacuum is initially drawn or applied to the inflation lumen 120.

[0049] In one embodiment, during step 444, the vibration source 226 moves or slides along the outer surface of the balloon catheter 100 while vibrating the balloon catheter. For example, the vibration source 226 can initially be placed in direct physical contact with the outer surface of the balloon 108. When air or bubbles trapped in the balloon 108 rise into the inflation lumen 120, the user can move or slide the vibration source 226 onto the outer surface of the outer shaft 110 along with the movement of air within the balloon catheter 100. It is preferred to maintain direct contact between the outer surface of the balloon catheter 100 and the vibration source 226 while moving the vibration source 226.

[0050] In step 446, similar to step 346, after no new air or bubbles are seen entering the inflator 224, the vacuum is removed from the inflation lumen 120 of the balloon catheter 100 by slowly releasing the plunger of the inflator 224 to a neutral position. Vibrations may continue to be applied by the vibration source 226 during this step, or the vibrations may be removed.

[0051] In step 447, if necessary, steps 442, 444, and 446 may be repeated to again flush the inflation lumen 120 of the balloon catheter 100. More specifically, it may be necessary to flush the inflation lumen 120 several times before proceeding to the subsequent method steps of closing and separating the stopcock 222 and purging all trapped air in the inflator 224. Thus, the operator may choose to repeat the steps of drawing a vacuum, maintaining the vacuum while applying vibrations to the balloon catheter 100, and then removing the vacuum as many times as desired before proceeding to the next method step.

[0052] In step 448, similar to step 348, the stopcock 222 leading into the balloon catheter 100 is closed. When the stopcock 222 is close to the balloon catheter 100, the inflator 224 is no longer in fluid communication with the inflation lumen 120 of the balloon catheter 100. The inflation lumen 120 of the balloon catheter 100 remains sealed relative to the atmosphere. At this step of the method, it is no longer necessary to apply vibrations to the balloon catheter 100 via the vibration source 226.

[0053] In step 450, similar to step 350, after closing the stopcock 222 leading to the balloon catheter, the inflator 224 is separated from the stopcock 222 and purged by advancing the plunger to force air out of the syringe. Any air accumulated in the inflator 224 during the previous steps is released or purged from the inflator 224.

[0054] In step 452, similar to step 352, the operator decides or determines whether the air in the balloon catheter 100 is sufficiently purged. For example, the operator may visually inspect the balloon catheter 100 to determine whether any additional bubbles are still present within the balloon catheter 100. The operator may also determine whether the air in the balloon catheter 100 is sufficiently purged based on observation of the rate and size of air or bubbles entering the inflator 224 during step 444. If the rate of air or bubbles is relatively slow and / or the size of the air or bubbles is relatively small, the operator may determine that the air in the balloon catheter 100 is sufficiently purged. If the operator determines that the air in the balloon catheter 100 is sufficiently purged, the balloon catheter preparation method is considered complete at step 454. However, if the operator determines that the air in the balloon catheter 100 has not been adequately purged, then the inflator 224 is reconnected to the stopcock 222 and the above-described steps of applying or pulling a vacuum on the inflation lumen 120 of the balloon catheter 100 using the inflator while vibrating the balloon catheter 100 with the vibration source 226 are repeated until the air or bubbles are completely purged out of the balloon 108 and the inflation lumen 120. More specifically, steps 434, 436, 438, 440, 442, 444, 446, 447, 448, and 450 are repeated as necessary until all air is removed from the balloon catheter.

[0055] exist Figure 3 and 4 In the above method of the present invention, during the described method, the inflator 224 is used to manually draw a vacuum and inject or insert the inflation fluid into the balloon catheter 100. However, in another embodiment, it is not necessary to draw a vacuum with the inflator 224, such as Figure 5 In other words, in one embodiment, only the vibrations of the vibration source 224 can be used to purge air from the balloon catheter 100. Figure 3 method, Figure 5 The method is preferably performed prior to an interventional procedure using in situ balloon catheter 100. This method is particularly advantageous for balloon catheters having larger balloons, such as, but not limited to, balloon catheters configured as delivery devices for replacement heart valves, because the method significantly reduces the length of catheter preparation time by applying the vibration source 226 to expedite the removal of bubbles / air from the balloon catheter as described above.

[0056] In step 530, similar to step 330, the balloon catheter 100 is removed from its packaging. The stopcock 222 is attached to the inflation port at the proximal portion 102 of the balloon catheter 100. More specifically, the stopcock 222 is attached to the inflation port of the Luer fitting 105 of the hub 104 of the balloon catheter 100. As described above, the distal portion 106 of the balloon catheter 100 contains the balloon 108, and the inflation lumen 120 of the balloon catheter 100 is in fluid communication with the interior of the balloon 120. Although the balloon catheter 100 is described with respect to the inflation port 108, the inflation lumen 120 of the balloon catheter 100 is in fluid communication with the interior of the balloon 120. Figure 5 However, one of ordinary skill in the art will understand that this is for illustration only and the method described herein for purging air in a balloon catheter can be used for balloon catheters of any configuration and size.

[0057] In step 532, similar to step 332, the inflator 224 is prepared by at least partially filling the inflator 224 with an inflation fluid. In one embodiment, the inflator 224 is a syringe and the inflation fluid is a radiopaque contrast fluid, or a radiopaque contrast fluid mixed with saline or water. Other suitable biocompatible inflation fluids may be used.

[0058] In step 534, similar to step 334, the inflator 224 is attached to the stopcock 222, which was previously attached to the inflation port of the Luer fitting 105 of the hub 104 of the balloon catheter 100 as described above, and the stopcock 222 is passed into the balloon catheter 100. When the stopcock 222 is passed into the balloon catheter 100, the inflator 224 is in fluid communication with the inflation lumen 120 of the balloon catheter 100, and the inflation lumen 120 of the balloon catheter 100 is sealed relative to the atmosphere. Alternatively, the inflator 224 can be attached to the stopcock 222, and then the combination of the inflator 224 and the stopcock 222 can be simultaneously attached to the inflation port at the proximal portion 102 of the balloon catheter 100.

[0059] In step 536, similar to step 336, the inflation lumen 120 is at least partially filled with the inflation fluid from the inflator 224. To at least partially fill the inflation lumen 120 with the inflation fluid from the inflator, the inflation fluid may be injected or inserted into the inflation lumen 120 of the balloon 108 of the balloon catheter 100 through the inflator 224 by advancing the plunger of the inflator 224. In another embodiment, to at least partially fill the inflation lumen 120 with the inflation fluid from the inflator, a vacuum may be applied or pulled on the inflation lumen 120 of the balloon catheter 100 through the inflator 224, and then the vacuum may be removed by slowly releasing the plunger of the inflator 224 to a neutral position, thereby at least partially filling the inflation lumen 120 with the inflation fluid from the inflator. More specifically, the user may manually apply or pull a vacuum on the inflation lumen 120 of the balloon catheter 100 by “negatively pulling” or retracting the plunger of the inflator 224. When the plunger of the inflator 224 is released to the neutral position, the inflation fluid within the inflator 224 is drawn into the balloon catheter 100 and the inflation lumen 120 is at least partially filled with the inflation fluid. In other words, the removal of the vacuum causes the inflation fluid from the inflator 224 to be pulled into the balloon catheter 100, so that the inflation lumen 120 and the balloon 108 are filled with the inflation fluid. The inflation fluid is drawn into the inflation lumen 120 and the balloon 108 due to the pressure change of the closed system.

[0060] In step 538, similar to step 338, the balloon catheter 100 is inverted or positioned in an inverted orientation such that the distal portion 106 containing the balloon 108 is oriented to be below or facing downward relative to the proximal portion 102 of the balloon catheter and the inflator 224 coupled thereto. In one embodiment, the balloon catheter 100 is positioned in a vertical orientation with its distal end containing the balloon 108 disposed vertically below the hub 104 and the inflator 224. However, the balloon catheter 100 need not be oriented vertically; the balloon catheter 100 may be oriented at an angle as long as the distal portion 106 containing the balloon 108 of the balloon catheter is oriented to be below or facing downward relative to the inflator 224. As will be described in more detail herein, positioning the inflator 224 above the balloon catheter 100 allows bubbles to ascend / rise through the column of inflation fluid in the inflation lumen 120 and to be expelled from the balloon catheter 100 through the inflator 224.

[0061] In step 540, similar to step 340, vibration source 226 is positioned to directly contact the outer surface of the balloon catheter. In one embodiment, vibration source 226 is a hand-held tool configured to be held by a user. In one embodiment, vibration source 226 includes an outer surface configured to be held by a user and includes an inner surface (not shown) configured to be in direct physical contact with the outer surface of balloon 108 and / or the outer surface of outer shaft 110. For example, the inner surface of vibration source 226 can have a shape corresponding to the outer surface of balloon 108 and / or the outer surface of outer shaft 110.

[0062] In step 544, vibrations are applied to the balloon catheter 100 by the vibration source 226. The balloon catheter 100 is vibrated by the vibration source 226 to move air within the balloon 108 of the balloon catheter 100 or air within the inflation lumen 120 of the balloon catheter 100 upward toward the proximal end of the balloon catheter 100 and the inflator 224. In other words, vibrations of the balloon catheter 100 by the vibration source 226 cause any air or bubbles trapped in the balloon catheter 100 to rise out of the balloon 108 and the inflation lumen 120 until such air or bubbles exit the balloon catheter 100 and enter the inflator 224. When air or bubbles exit the balloon catheter 100 and enter the inflator 224, the user can visually see such air or bubbles in the inflator 224. The vibrations are applied to the balloon catheter 100 until no new air or bubbles are seen entering the inflator 224. For example, in one embodiment, vibrations are applied to the balloon catheter for 15 to 45 seconds. In one embodiment, vibrations are applied to the balloon catheter for approximately 30 seconds.

[0063] In one embodiment, during step 544, the vibration source 226 moves or slides along the outer surface of the balloon catheter 100 while vibrating the balloon catheter. For example, the vibration source 226 can initially be placed in direct physical contact with the outer surface of the balloon 108. As air or bubbles trapped in the balloon 108 rise into the inflation lumen 120, the user can move or slide the vibration source 226 onto the outer surface of the outer shaft 110 along with the movement of air within the balloon catheter 100. It is preferred to maintain direct contact between the outer surface of the balloon catheter 100 and the vibration source 226 while moving the vibration source 226.

[0064] In step 548, similar to step 348, the stopcock 222 leading into the balloon catheter 100 is closed. When the stopcock 222 is close to the balloon catheter 100, the inflator 224 is no longer in fluid communication with the inflation lumen 120 of the balloon catheter 100. The inflation lumen 120 of the balloon catheter 100 remains sealed relative to the atmosphere. At this step of the method, it is no longer necessary to apply vibrations to the balloon catheter 100 via the vibration source 226.

[0065] In step 550, similar to step 350, after closing the stopcock 222 leading to the balloon catheter, the inflator 224 is separated from the stopcock 222 and purged by advancing the plunger to force air out of the syringe. Any air accumulated in the inflator 224 during step 544 is released or purged from the inflator 224.

[0066] In step 552, similar to step 352, the operator decides or determines whether the air in the balloon catheter 100 is sufficiently purged. For example, the operator may visually inspect the balloon catheter 100 to determine whether any additional bubbles are still present within the balloon catheter 100. The operator may also determine whether the air in the balloon catheter 100 is sufficiently purged based on observation of the rate and size of the air or bubbles entering the inflator 224 during step 544. If the rate of the air or bubbles is relatively slow and / or the size of the air or bubbles is relatively small, the operator may determine that the air in the balloon catheter 100 is sufficiently purged. If the operator determines that the air in the balloon catheter 100 is sufficiently purged, the balloon catheter preparation method is considered complete at step 554. However, if the operator determines that the balloon catheter 100 has not been adequately purged of air, the inflator 224 is then reconnected to the stopcock 222 and the steps described above, including vibrating the balloon catheter 100 with the vibration source 226, are repeated until the air or bubbles are completely purged from the balloon 108 and the inflation lumen 120. More specifically, steps 534, 536, 538, 540, 544, 548, and 550 are repeated as necessary until all air is removed from the balloon catheter.

[0067] Although only some embodiments according to the present invention are described herein, it should be understood that the embodiments are presented only by figures and examples and in a non-restrictive manner. Various changes may be made in form and detail without departing from the spirit and scope of the present invention. Further, each feature of each embodiment discussed herein and each reference cited herein may be used in combination with the features of any other embodiment. All patents and open documents discussed herein are incorporated herein by reference as a whole.

Claims

1. A method for purging air in a balloon catheter, the method comprising the following steps: inserting an inflation fluid into a balloon and an inflation lumen of a balloon catheter, wherein the inflation lumen is in fluid communication with the balloon; positioning the balloon catheter in an inverted orientation with its distal end disposed below its proximal end, wherein the distal end of the balloon catheter contains the balloon; positioning a vibration source in direct contact with an outer surface of the balloon catheter; vibrating the balloon catheter with the vibration source so that air in the balloon of the balloon catheter or air in the inflation chamber of the balloon catheter moves upward toward the proximal end of the balloon catheter; as well as While vibrating the balloon catheter, the vibration source is moved along the outer surface of the balloon catheter, wherein Direct contact between the outer surface of the balloon catheter and the vibration source is maintained during the step of moving the vibration source.

2. The method of claim 1, wherein the method for purging air in the balloon catheter is performed prior to an interventional procedure.

3. The method according to claim 1, further comprising the steps of: attaching an inflator to the proximal end of the balloon catheter; and A vacuum is applied to the inflation lumen of the balloon catheter using the inflator while the balloon catheter is vibrated using the vibration source.

4. The method of claim 3, wherein the inflator is a syringe having the inflation fluid therein.

5. The method according to claim 3, further comprising the steps of: After the step of applying the vacuum on the inflation lumen of the balloon catheter using the inflator, detaching the inflator from the proximal end of the balloon catheter; as well as Air that has accumulated in the inflator is removed from the inflator.

6. The method according to claim 5, further comprising the steps of: after said step of removing air from said inflator, reattaching said inflator to said proximal end of said balloon catheter; as well as The steps of applying a vacuum on the inflation lumen of the balloon catheter using the inflator while vibrating the balloon catheter using the vibration source are repeated.

7. The method of claim 3, wherein during the step of applying a vacuum on the inflation lumen of the balloon catheter using the inflator, a stopcock seals the balloon catheter.

8. The method of claim 1, wherein the balloon catheter is configured as a delivery device for replacing an aortic heart valve.

9. A method for purging air from a balloon catheter, the method comprising the steps of: inserting an inflation fluid into a balloon and an inflation lumen of a balloon catheter, wherein the inflation lumen is in fluid communication with the balloon; positioning the balloon catheter in an inverted orientation with its distal end disposed below its proximal end, wherein the distal end of the balloon catheter contains the balloon; positioning a vibration source in direct contact with an outer surface of the balloon catheter; applying a vacuum to the inflation lumen of the balloon catheter; vibrating the balloon catheter with the vibration source while applying the vacuum to the inflation lumen of the balloon catheter to move any air within the balloon of the balloon catheter and any air within the inflation lumen of the balloon catheter upwardly toward the proximal end of the balloon catheter through the inflation fluid; as well as While vibrating the balloon catheter, the vibration source is moved along the outer surface of the balloon catheter, wherein Direct contact between the outer surface of the balloon catheter and the vibration source is maintained during the step of moving the vibration source.

10. The method of claim 9, wherein the method for purging air in the balloon catheter is performed prior to an interventional procedure.

11. The method of claim 9, wherein the steps of inserting the inflation fluid into the balloon and the inflation lumen and applying the vacuum on the inflation lumen are performed by an inflator attached to the proximal end of the balloon catheter.

12. The method of claim 11, wherein the inflator is a syringe.

13. The method according to claim 11, further comprising the steps of: After the step of vibrating the balloon catheter with the vibration source while applying the vacuum to the inflation lumen of the balloon catheter, detaching the inflator from the proximal end of the balloon catheter; as well as Any air that has accumulated in the inflator is removed from the inflator.

14. The method according to claim 13, further comprising the steps of: after said step of removing from said inflator any air that has accumulated in said inflator, reattaching said inflator to said proximal end of said balloon catheter; as well as The method for purging air from the balloon catheter is repeated until all air is purged from the balloon catheter.

15. The method of claim 9, wherein a stopcock seals the balloon catheter during the step of applying the vacuum to the inflation lumen of the balloon catheter.

16. The method of claim 9, wherein the balloon catheter is configured as a delivery device for replacing an aortic heart valve.

17. A method for purging air from a balloon catheter, the method comprising the steps of: inserting an inflation fluid into a balloon and an inflation lumen of a balloon catheter, wherein the inflation lumen is in fluid communication with the balloon; positioning the balloon catheter in an inverted orientation with its distal end disposed below its proximal end, wherein the distal end of the balloon catheter contains the balloon; positioning a vibration source in direct contact with an outer surface of the balloon catheter; vibrating the balloon catheter with the vibration source; applying a vacuum to the inflation lumen of the balloon catheter; as well as While vibrating the balloon catheter, the vibration source is moved along the outer surface of the balloon catheter, wherein maintaining direct contact between the outer surface of the balloon catheter and the vibration source during the step of moving the vibration source; Wherein the steps of vibrating the balloon catheter and applying the vacuum are performed simultaneously.

18. The method of claim 17, wherein the balloon catheter is configured as a delivery device for replacing an aortic heart valve.

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