Patent ID: 12226601

DETAILED DESCRIPTION

FIGS.1-5illustrate a first embodiment of a balloon catheter10constructed in accordance with one embodiment of the disclosed inventions. The balloon catheter10is configured generally for performing a procedure within a vascular system, such as treating ischemic strokes and/or for blocking or restricting blood flow for other treatment or diagnostic purposes. In particular with respect to the disclosed inventions, the balloon catheter10is specially configured to allow for fast preparation for performing a surgical procedure, including providing for fast and effective purging of air from the respective balloon inflation lumen18and balloon interior36(FIG.5), as described in greater detail below.

The balloon catheter10includes an elongated, flexible, tubular body12having a proximal portion14, a distal portion16and an inner working lumen17extending therebetween. The working lumen17is in fluid communication with a distal opening27at a distal end11of the tubular body12, and with a proximal opening21defined by a proximal end hub19(further described below) secured to the proximal portion14of the tubular body12.

The tubular body12includes an outer tubular member26and an inner tubular member28coaxially disposed within the outer tubular member26. The respective outer and inner members26and28may each be made of a polymeric tube, or other suitable material, and may have one or more reinforcing members (not shown) to provide reinforced and/or stiffened portions, as is well-known in the art. For example, a coil, braid, ribbon, hypotube, or other structural member may be disposed on the inside, on the outside, and/or embedded within a wall of one or both of the inner and outer members28and26along predetermined portion thereof. Such reinforcing members may be made of any suitable material, such as a super-elastic alloy or shape-memory material to provide a specific shape to the reinforced portion of the tubular body12under certain conditions.

As mentioned above, the balloon catheter10further includes a proximal end hub19secured to the proximal portion14of the tubular body12(i.e., to each of the inner and outer tubular members28and26), wherein the hub19defines the proximal end opening21of the working lumen17. The hub19includes a balloon inflation port20in fluid communication with the proximal end of a balloon inflation lumen18that is formed by an annular space between an inner surface of the outer tubular member26and an outer surface of the inner tubular member28. The inflation lumen18extends along the length of the tubular body12from the balloon inflation part20to an inflatable interior36(best seen inFIG.5in which the balloon interior36) of a balloon formed by an elastomeric balloon member30attached to the distal end portion16of the tubular body12. It should be appreciated that the outer and inner tubular member26and28may be bonded to each other at one or more locations (not shown) distal of the hub19. However, such bonds are not fully circumferential so as to ensure the inflation lumen is continuous from the inflation port20to the balloon interior. Alternatively, the inflation lumen18may be one or more channels, conduits, tubes, etc., formed in, or attached to, the wall of the tubular body12.

In the illustrated embodiment, the balloon member30has a proximal portion32bonded around a circumference of, so as to form a seal with, an outer surface of a distal end portion of the outer tubular member26, and a distal end portion34bonded around a circumference of, so as to form a seal with, an outer surface of a distal end portion of the inner tubular member28, such that an inner surface of the balloon member30and an outer surface of the inner tubular member28(extending beyond the end of the outer tubular member26) define the inflatable balloon interior36(FIG.5). It should be understood that, in alternate embodiments, the balloon member30may be secured at any suitable location on the tubular body12, such as proximal to the distal portion16, in the middle portion of the tubular body12, etc.

The balloon inflation port20is configured to be connected to an inflation syringe22(not drawn to scale) and/or an inflation (e.g., contrast) media reservoir24for prepping the catheter10for a surgical procedure. For example, the inflation port20may have a female Luer lock (not shown) for attaching the inflation syringe22, or other fluid source, having a mating male Luer lock. The proximal end opening21of the working lumen17is configured to be selectively connected to a vacuum source, such as a purging or “aspiration” syringe23(not drawn to scale). Towards this end, the hub19may have a female Luer lock (not shown) for attaching the aspiration syringe23, or other aspirating device, having a mating male Luer lock.

A pair of purge apertures40aand40bare disposed approximately 180° offset from each other around the circumference of the inner tubular member28within the inflatable balloon interior36. In the illustrated embodiment, each purge aperture40a,40bis a small opening formed through the inner tubular member28that creates a fluid flow path between the balloon interior36and the working lumen17. A corresponding pair of purge grooves42aand42bare formed in the outer surface of the inner tubular member28approximately 180° offset from each other around the circumference of the inner tubular member28, with purge groove42aextending from the inflation lumen18to purge aperture40a, and purge groove42bextending from the inflation lumen18to purge aperture40b. As better shown in the top view of the tubular member12inFIG.2, purge groove42ais a narrow groove formed in the outer surface of the inner tubular member28that extends longitudinally (i.e., in the direction of the longitudinal axis of the tubular body12) from the distal end38of the inflation lumen18to the purge aperture40a. While not separately depicted in a top view, purge groove42bis also a narrow groove formed in the outer surface of the inner tubular member28that extends longitudinally from the distal end38of the inflation lumen18to the purge aperture40b. The respective purge grooves42aand42bfunction to maintain a fluid flow path between the inflation lumen18and the respective purge apertures40aand40bunderneath the balloon member30when the balloon member30is collapsed (deflated) onto the outer surface of the inner tubular member28(as shown inFIG.1).

In alternate embodiments, the balloon catheter10may have only a single purge aperture and purge groove, or it may have three, four, five, six, or more purge apertures and corresponding purge grooves, which may be evenly (or unevenly) spaced angularly around the circumference of the tubular body12. In the case of multiple purge apertures and respective purge grooves42connecting each to the balloon inflation lumen18, the structure of each purge aperture40and respective purge groove42is preferably substantially the same as those shown in the figures and described herein.

A method of preparing the balloon catheter10for use in a medical procedure will now be described with reference toFIGS.3-5. The method is specifically directed to purging air from the balloon catheter10and inspecting the balloon catheter10for leaks prior to use of the balloon catheter in a surgical procedure. The innovative design of the balloon catheter10advantageously allows it to be effectively purged in a single, fast aspiration procedure.

Referring toFIG.3, first, the distal end opening27of the working lumen17is plugged (i.e., corked) with a tip plug44. Alternatively, the distal end of the working lumen17may be plugged using a finger of a user, or other suitable means. A reservoir (e.g., injection syringe)22containing an inflation media25, such as a saline/contrast agent mixture, is fluidly connected to the inflation port20, and a vacuum source (e.g., purging syringe)23is fluidly connected to the proximal opening of the working lumen17. The inflation media is introduced from the inflation syringe22into the respective inflation port20, inflation lumen18and inflatable balloon interior36. At the same time, the plunger on the purging syringe23is pulled back to create a vacuum in the working lumen17, which draws the inflation fluid25from the distal opening of the inflation lumen38, through the respective purge grooves42a,42band purge apertures40aand40b, and into the working lumen17, thereby purging any air trapped in the respective inflation lumen18, balloon interior36and working lumen17of the balloon catheter10.

As shown inFIG.4, after the interior passages of the balloon catheter have 10 been purged of air by the inflation media25, but before inflation of the balloon interior36, particles of the inflation media25form clogging matter “plugs”41a,41bwhich seal the respective purge apertures40a,40b. Thereby isolating the balloon interior36from the working lumen17. In particular, the purge apertures40a,40bhave a relatively small diameter that allows air molecules to pass through, but get quickly clogged by the inflation media25comprising a contrast agent (e.g., a saline/contrast agent mixture) that coagulates to form the plugs41a,41b, thereby sealing the purge apertures40a,40b, respectively. For example, the purge apertures40a,40bmay have a diameter from 0.010 mm to 0.10 mm, or from 0.030 mm to 0.070 mm, or from 0.010 mm to 0.025 mm. The diameter of each purge aperture40a,40band the composition of the inflation media25are preferably configured/selected such that the inflation fluid25forms the plugs41a,41bwhich seal the purge apertures40a,40b, within about 3 minutes, or from 1 to 5 minutes, or from 2 to 4 minutes, or less than 5 minutes, or less than 10 minutes, in various embodiments.

Once the purge apertures40a,40bare sealed by the coagulated contrast material plugs41a,41b, the purging syringe23may then be removed from the proximal opening21of the working lumen17, e.g., by detaching the male Luer lock of the purging syringe23from the female Luer lock of the opening21. In the case that the proximal opening21of the working lumen includes a Luer fitting, the Luer fitting automatically seals the opening when the purging syringe23is removed. Alternatively, the proximal opening21of the working lumen may be sealed, e.g., by inserting a plug (not shown) into the opening21to keep the working lumen17purged of air.

The preparation method may also include inspecting the inflated balloon member30for leaks. Since the purge apertures40a,40bare sealed by the plugs41a,41b, the pressure from the inflation media25injected into the inflation port20inflates and expands the balloon member30. The balloon member30can then be checked for leakage visually and/or by detecting for pressure decay. The plunger on the inflation syringe22is then retracted to create negative pressure on the inflation port20and inflation lumen18to deflate the balloon member30. The inflation syringe22may optionally be removed, and the inflation port20sealed, to maintain the entire balloon catheter10purged of air. If the inflation port utilizes a Luer fitting, the Luer fitting automatically seals the inflation port20when the inflation syringe22is removed. The balloon catheter10is now purged of air, checked for leaks, and prepared for use in a medical procedure.

The method of using the prepped balloon catheter10in a medical procedure may include any suitable use of the balloon catheter10. In one exemplary method, the balloon catheter10is advanced through an insertion site of a patient and into the vascular system of the patient, such as a vein or artery. Once the balloon member30is positioned at a target location within the vascular system, the balloon member30is inflated by attaching an inflation syringe22filled with inflation media onto the inflation port20(e.g., by attaching a male Luer lock of the inflation syringe22to the female Luer lock of the inflation port20), and injecting inflation media25into the inflation lumen18. Since the purge apertures40a,40bremain sealed, the pressurized inflation media25from the inflation syringe22inflates and expands the balloon member30and balloon interior36.

Referring toFIG.12, an alternate embodiment of the balloon catheter, designated as10′, is constructed substantially the same as the balloon catheter ofFIGS.1-5, except that the purge apertures, designated as40a′ and40b′ are located proximate the distal end38of the inflation lumen18instead of underlying the balloon member30. As such, there is no need for the purge grooves42. Preparation of the alternative balloon catheter10′ is otherwise the same as for balloon catheter10.

FIGS.10and11depict yet another alternative embodiment of the balloon catheter10, designated as70. The alternative balloon catheter70is constructed substantially the same as the balloon catheter10ofFIGS.1-5, except that the purge grooves42a,42bformed in the outer surface of the inner tubular member28are replaced by purge channels63a,63bformed by respective parallel raised ribs61a,61b(shown for channel63ainFIG.11) on the outer surface of the inner tubular member28, extending from the distal end38of the inflation lumen18to respective purge apertures72aand72bformed through the wall of the inner tubular member28. Although only channel63ais shown in detail (FIG.11), channel63bis substantially identically formed by a pair of parallel ribs approximately 180° circumferentially offset from channel63a. In all other aspects, the alternative balloon catheter70is the same, and is prepared the same, as balloon catheter10.

Referring toFIGS.6-9, another embodiment of a balloon catheter60is illustrated. The balloon catheter60is substantially the same as the balloon catheter10, except that instead of purge apertures40a,40b, the balloon catheter60has respective purge channels62a,62b. The purge channels62a,62bperform the same function as the purge apertures40a,40bin catheter10. In particular, the purge channels62a,62bprovide a flow path between the inflatable balloon interior36and the working lumen17of the tubular body12. The purge channels62a,62beach comprises a fluid channel proximate the distal end11of the tubular body12within the inflatable balloon interior36. The purge channels62a,62bextend from respective purge apertures64a,64bin the wall of the tubular body12at the distal end of the purge grooves42a,42bto an outlet within the inflatable balloon interior36. The respective purge channels62a,62bmay each be formed when punching a hole through the wall of the inner tubular member28. Like the purge apertures40a,40bof catheter10, the purge channels62a,62bare automatically sealed by the inflation media25(e.g., a saline/contrast agent mixture) when purging the balloon catheter60of air. In addition, while purging the balloon catheter60and/or inflating the balloon member30during use, the fluid pressure of the inflation media25in the balloon interior36collapses the respective purge channels62a,62b, thereby providing a second, or backup, seal of the purge apertures64a,64b.

As shown inFIGS.14-15, with the collapsing purge channel feature, the balloon catheter60may also be purged and/or used in a medical procedure when injecting an inflation media25that does not have particles which form plugs41a,41b. Accordingly, the balloon catheter60may be purged and/or used in a medical procedure with inflation media25, such as saline, water, or other suitable media, which does not form clogging matter plugs in the purge channels62a,62b. As shown inFIGS.14-15, the fluid pressure of the inflation media25collapses the purge channels62a,62b, thereby sealing the purge apertures64a,64b.

In alternative embodiments, the balloon catheter60may have one or more purge channels62and corresponding purge grooves42. In the illustrated embodiment ofFIGS.6-9the balloon catheter60has two purge channels62a,62bfluidly coupled with respective purge grooves42a,42bspaced approximately 180° apart on the inner tubular member28. In other embodiments, the balloon catheter60may have three, four, five, six, or more purge apertures40and corresponding purge grooves42, which may be evenly (or unevenly) spaced angularly around the circumference of the inner tubular member28. In the case of multiple purge channels62and purge grooves42, the structure of each purge channel62and purge groove42is preferably substantially the same as those shown in the figures and described herein.

The method of preparing the balloon catheter60for use in a medical procedure is similar to the above-described method for preparing the balloon catheter10, preferably including purging air from the balloon catheter60and inspecting the balloon member30for any leaks. As with the balloon catheter10, the balloon catheter60may also be effectively purged in a single, fast aspiration procedure.

Referring toFIG.7, first, the distal opening27of the working lumen17is plugged using a tip plug44. Alternatively, the distal end of the working lumen17may be plugged using a finger of a user, or other suitable means. A reservoir22of inflation media25(such as an inflation syringe22filled with a saline/contrast agent mixture) is attached to the inflation port20. If Luer locks are used, a male Luer lock of the reservoir22is attached to the female Luer lock of the inflation port20. In the embodiment ofFIG.7, a syringe22filled with inflation media25is attached to the inflation port20. Then, a vacuum source (e.g., purging syringe)23is attached to the proximal opening21of the working lumen17. With Luer locks, a male Luer lock of the vacuum source23is attached to the female Luer lock of the proximal lumen opening21. The inflation media is introduced from the inflation syringe22into the respective inflation port20, inflation lumen18and inflatable balloon interior36. At the same time, the plunger on the purging syringe23is pulled back to create a vacuum in the working lumen17, which draws the inflation fluid25from the distal opening of the inflation lumen38, through the respective purge grooves42a,42b, purge channels62aand62b, and into the working lumen17via purge apertures64a,64b, thereby purging any air trapped in the respective inflation lumen18, balloon interior36and working lumen17of the balloon catheter60.

As shown inFIG.8, after the balloon catheter60has been purged with inflation media25, the coagulated inflation media25forms respective plugs41a,41bthat seal the purge channels/apertures62a,62band64a,64b. In particular, the purge channels62a,62bhave a small diameter such that the inflation media25comprising a contrast agent (e.g., a saline/contrast agent mixture) will form the plugs41a,41b, thereby sealing the purge channels/apertures62a,62band64a,64bwithin a certain sealing time from when the inflation media25is introduced. For example, the purge channels62a,62bmay have a diameter from 0.010 mm to 0.10 mm, or from 0.030 mm to 0.070 mm, or from 0.010 mm to 0.025 mm. The diameter of the purge channels62a,62band composition of the inflation media25may be configured/selected such that the inflation fluid25forms the sealing plugs41a,41bwithin about 3 minutes, or from 1 to 5 minutes, or from 2 to 4 minutes, or less than 5 minutes or less than 10 minutes. The purge channels62a,62bmay also be sealed when the fluid pressure of the inflation media25(e.g., the fluid pressure of the inflation media25in the balloon interior36) collapses the respective purge channels62a,62band seals the purge channels62a,62b.

With reference toFIGS.9and9A, once the purge channels/apertures62a,62band64a,64bare sealed by the contrast material plugs41a,41b, the purging syringe23may then be removed from the proximal end opening21of the working lumen17, e.g., by detaching the male Luer lock of the purging syringe23from the female Luer lock of the opening21. In the case that the proximal opening21of the working lumen includes a Luer fitting, the Luer fitting automatically seals the opening when the purging syringe23is removed. Alternatively, the proximal opening21of the working lumen may be sealed, e.g., by inserting a plug (not shown) into the opening21to keep the working lumen17purged of air.

As with the balloon catheter10, the preparation of the balloon catheter60preferably also includes inspecting the inflated balloon member30for leaks. Since the purge channels/apertures62a,62band64a,64bare sealed by the contrast material plugs41a,41b, the pressure from the inflation media25injected into the inflation port20inflates and expands the balloon member30. The balloon member30can then be checked for leakage visually and/or by detecting for pressure decay. The plunger on the inflation syringe22is then retracted to create negative pressure on the inflation port20and inflation lumen18to deflate the balloon member30. The inflation syringe22may optionally be removed, and the inflation port20sealed, to maintain the entire balloon catheter60purged of air. If the inflation port utilizes a Luer fitting, the Luer fitting automatically seals the inflation port20when the inflation syringe22is removed. The balloon catheter60is now purged of air, checked for leaks, and prepared for use in a medical procedure.

The method of using the prepped balloon catheter60in a medical procedure may include any suitable use of the balloon catheter. In one exemplary method, the balloon catheter60is advanced through an insertion site of a patient and into the vascular system of the patient, such as a vein or artery. Once the balloon member30is positioned at a target location within the vascular system, the balloon member30is inflated by attaching an inflation syringe22filled with inflation media onto the inflation port20(e.g., by attaching a male Luer lock of the inflation syringe22to the female Luer lock of the inflation port), and injecting inflation media25into the inflation lumen18. Since the purge channels/apertures62a,62band64a,64bremain sealed, the pressurized inflation media25from the inflation syringe22inflates and expands the balloon member30. In addition, the inflation pressure also collapses the purge channels62a,62b, providing a backup seal.

The method of preparing the balloon catheter60for use in a medical procedure and/or using the balloon catheter60with an inflation media25that does not form plugs (e.g., saline or water) is the same as described above, except that the inflation media25does not form the plugs41a,41b. Instead, as shown inFIGS.14-15, the purge channels/apertures62a,62band64a,64bare sealed when the fluid pressure of the inflation media25collapses the respective purge channels62a,62b.

Although particular embodiments have been shown and described, it is to be understood that the above description is not intended to limit the scope of these embodiments. While embodiments and variations of the many aspects of the invention have been disclosed and described herein, such disclosure is provided for purposes of explanation and illustration only. Thus, various changes and modifications may be made without departing from the scope of the claims. For example, not all of the components described in the embodiments are necessary, and the invention may include any suitable combinations of the described components, and the general shapes and relative sizes of the components of the invention may be modified. Accordingly, embodiments are intended to exemplify alternatives, modifications, and equivalents that may fall within the scope of the claims. The invention, therefore, should not be limited, except to the following claims, and their equivalents.