Patent Description:
The present invention relates to hemostasis devices (e.g., bands) that are adapted to act as compression devices to promote hemostasis at a surgical access site, and more particularly to hemostasis bands having folded balloon assemblies. In particular, the present invention relates to a balloon assembly for a hemostasis device according to the preamble of claim <NUM>, such as it is e.g. known from <CIT>.

After a surgical procedure involving arterial or venous access, it may be desirable or necessary to apply pressure to the vascular access site to promote hemostasis. Some existing hemostasis devices use one or more inflatable balloons to apply pressure to the access site. In some instances, these balloons have experienced failures. Some existing hemostasis devices may also be time-consuming and expensive to construct. Accordingly, there is a need for hemostasis devices that address these and other drawbacks of the prior art.

These problems are solved by a balloon for a hemostasis device according to independent claim <NUM>. The dependent claims relate to advantageous embodiments.

The present invention will hereinafter be described in conjunction with the appended drawing figures, wherein like numerals denote like elements.

The ensuing detailed description provides exemplary embodiment(s) only, and is not intended to limit the scope, applicability, or configuration thereof. Rather, the ensuing detailed description of the exemplary embodiment(s) will provide those skilled in the art with an enabling description for implementing these embodiment(s). It should be understood that various changes may be made in the function and arrangement of elements of the embodiment(s) without departing from the scope of the invention, as set forth in the appended claims.

Directional terms (e.g., upper, lower, left, right, etc.) may be used herein. These directional terms are merely intended to assist in disclosing the embodiment(s) and claiming the invention and are not intended to limit the claimed invention in any way. In addition, reference numerals that are introduced in the specification in association with a drawing figure may be repeated in one or more subsequent figure(s) without additional description in the specification, in order to provide context for other features.

Peripheral vascular interventions are commonly used to attempt to clear occlusions from, or surgically introduce stents into, vascular pathways. For example, antegrade crossing via the radial artery in a patient's wrist is common, and various retrograde approaches upwardly from below a patient's knee are also established procedures. After such a procedure, the vascular (i.e., either arterial or venous) access site is typically closed through application of pressure to encourage hemostasis.

Hemostasis devices that are wrapped around a patient's limb at a site on the limb where bleeding is to be stopped, and which include one or more inflatable balloons or bladders that target pressure at a vascular access site, are known in the art. Multiple embodiments of one such hemostasis device and methods of using such devices are described in <CIT>. Additional embodiments of such hemostasis devices and methods of using same are described in <CIT>. It should be understood that the devices and methods taught herein could be used or adapted for use with any of the hemostasis devices taught in the references noted above in this paragraph.

As discussed in the '<NUM> Patent noted above, such hemostasis devices generally include a rigid member (e.g., a curved plate that slips into a band) and at least one inflatable balloon that, when inflated, expands in a direction away from the rigid member and presses into a targeted location on a patient's limb or other body part, thereby promoting hemostasis. Many of these devices have a dual-balloon design including a connection port that connects the chambers of the two balloons in fluid-flow connection, such that inflating one balloon will cause the fluid (e.g., air) to flow through the connection port and fill the other balloon. These connection ports are typically made via radio frequency ("RF") welding or bonding between faces of the adjacent balloons. In some instances these connection ports can fail, thus causing the balloon assembly of the hemostasis device to fail to properly inflate. The connection port design also requires multiple manufacturing steps and costly and time-consuming manual placement of components during the construction process. Accordingly, there is a need for improved balloon assembly structures and methods of constructing same.

The present invention describes various embodiments of improved balloon assembly structures, each of which omit the connection port between the balloons. Several of these embodiments are formed of two or more layers of material (e.g., vinyl or PVC) connected together via a single welded perimeter and then folded to form a balloon assembly that includes both the large balloon and small balloon at the same time with an open air channel between the two sections. Said another way, the two or more balloon chambers and the air channel that connects between the balloon chambers collectively form a contiguous air chamber, with each component of the contiguous air chamber having been at least partially formed by a single welding step. In an alternative embodiment according to the present invention, a plurality of balloons are formed and a multi-output connector splits the inflation tubing into the appropriate number of output connection tubes, each of which is separately routed into one of the plurality of balloons. In either approach, significantly fewer manufacturing steps are needed, placement of the components of the balloon assembly is simpler and more automatable, and the relatively-weak connection port is eliminated.

Referring now to <FIG>, various embodiments of balloon assemblies for hemostasis devices will be shown and described in detail. The hemostasis devices shown in the Figures are generally designed to be wrapped and secured in place around the arm <NUM> of a patient near the wrist to encourage hemostasis of the radial artery, as would be understood by a person having ordinary skill in the art. However, it should be understood that the concepts discussed in the present invention have applicability to other hemostasis devices that may be employed elsewhere on a patient's body, for example on any portion of any limb or the torso, neck, or head, and could be used for either arterial or venous hemostasis applications. Further, while it is generally desirable that the balloon assemblies according to the present invention be substantially transparent to permit visibility of the vascular access site (both for placement and for monitoring of complications), in alternative embodiments these balloon assemblies may be partially or entirely opaque.

<FIG> is a partial perspective view of a hemostasis device <NUM> including a balloon assembly <NUM> according to the prior art, in an uninflated state. <FIG> shows this balloon assembly <NUM> by itself in an uninflated state. As shown in <FIG> and <FIG>, the balloon assembly <NUM> is attached to an interior side <NUM> of a band <NUM> that faces a patient's arm <NUM> when worn, the band <NUM> further comprising an an exterior side <NUM> opposing the interior side <NUM> and an insert plate <NUM> inserted within layers (not labeled) of the band <NUM>. In this embodiment, the balloon assembly <NUM> comprises a small balloon <NUM> that is attached to the interior side <NUM> of the band <NUM> via an attachment hinge <NUM> and a large balloon <NUM> that is attached to the interior side <NUM> of the band <NUM> via an attachment hinge <NUM>. A length of connection tubing <NUM> enters the balloon assembly <NUM> via an inlet <NUM>, and a connection port <NUM> is formed between the small balloon <NUM> and large balloon <NUM> such that air entering the balloon assembly <NUM> via the connection tubing <NUM> can freely travel between the balloons <NUM>,<NUM> via the connection port <NUM>. As noted above, the connection port <NUM> is typically RF welded and is subject to occasional failure when the balloon assembly <NUM> is inflated (as shown in <FIG>).

<FIG> show various views of a balloon assembly <NUM> according to the present invention, and <FIG> and <FIG> show the balloon assembly <NUM> attached to a hemostasis device <NUM> according to the present invention. <FIG> show a "reverse end-fold" design for a balloon assembly <NUM> which has a single, welded outer perimeter <NUM> and a single, welded inner perimeter <NUM> around which a pair of air channels 134a,134b are formed. In this embodiment, both perimeters <NUM>,<NUM> are formed by laser welding the material layers together, but other construction methods are possible for connecting the material layers of the balloon assembly <NUM>, for example but not limited to RF welding or gluing. In this embodiment, a cutout <NUM> is made within the inner perimeter <NUM> after it has been formed so that the channels 134a,134b are separate portions which are located on opposite sides of the cutout <NUM>. In the alternative, the cutout <NUM> may be omitted so that the inner perimeter <NUM> surrounds a fully-welded region of two or more layers of material. In the present embodiment, the balloon assembly <NUM> is fully constructed by being folded about the fold line <NUM> so that a folded portion <NUM> is formed that includes the channels 134a, 134b, and a small balloon <NUM> is located atop a large balloon <NUM>. In this and other embodiments according to the present invention, placing the balloon assembly <NUM> in its folded configuration aligns a first portion of the channel 134a atop a second portion of the channel 134a and aligns a first portion of the channel 134b atop a second portion of the channel 134b.

Via a single welding step of forming the two perimeters <NUM>,<NUM>, the folded balloon assembly <NUM> of the present embodiment creates a dual-balloon structure comprising the small balloon <NUM>, the large balloon <NUM>, and the integrated air channels 134a,134b connecting the balloons <NUM>,<NUM>, thereby achieving elimination of the weak welded connection port of the prior art devices while reducing the number of steps involved in the construction process. The small balloon <NUM>, the large balloon <NUM>, and the integrated air channels 134a,134b collectively comprise a contiguous air chamber <NUM>, each component of which is formed at least in part by the single welding step. More particularly, the small balloon <NUM> has a perimeter <NUM>, the large balloon <NUM> has a perimeter <NUM>, and each of the air channels 134a,134b has a respective perimeter 135a,135b, and at least a portion of each of the perimeters <NUM>,<NUM>,135a,135b-specifically, respective outer edge portions of each perimeter <NUM>,<NUM>,135a,135b--is formed by the outer perimeter <NUM>.

In the embodiment shown in <FIG>, the balloon assembly <NUM> is comprised of three layers of material around its outer perimeter <NUM> and two layers of material around its inner perimeter <NUM>. In alternative embodiments, the balloon assembly <NUM> may be formed by attaching any plural number of material layers together about either or both of the outer perimeter <NUM> and inner perimeter <NUM>, in different combinations, as would be appreciated by a person having ordinary skill in the art.

Turning back to the embodiment of <FIG>, the balloon assembly <NUM> is attached to the hemostasis device <NUM> via two separate attachment hinges <NUM>,<NUM>, but in alternative embodiments a reverse end-fold balloon assembly design could have a single, shared attachment hinge by which the balloon assembly is attached to a hemostasis device. Further, while in the present embodiment two air channels 134a,134b are formed, this type of balloon assembly design could be formed with any number of air channels between the balloons <NUM>,<NUM>.

In the present embodiment, the balloon assembly <NUM> includes an indicator <NUM> located on the large balloon <NUM> that is used to help the clinician properly align the hemostasis device <NUM> on the patient's body part (i.e., adjacent to or atop the vascular access site) before, during, or after inflation of the balloon assembly <NUM>. Omitting a welded connection port from the balloon assembly <NUM> provides the additional benefit of enhancing the visibility of the indicator <NUM> and the underlying vascular access site, thereby increasing the likelihood that the clinician will perform the hemostasis procedure accurately. In alternative embodiments, the indicator <NUM> could be located elsewhere on the balloon assembly <NUM>, located elsewhere on the hemostasis device <NUM> (e.g., on the band or rigid insert plate), or omitted entirely.

<FIG> and <FIG> show the hemostasis device <NUM> comprising the balloon assembly <NUM> attached to a band <NUM> according to the invention of <CIT>. The hemostasis device <NUM> further comprises a rigid insert plate <NUM> that acts to direct the force of the inflated balloon assembly <NUM> towards the vascular access site, and complementary fastener patches <NUM>,<NUM> (e.g., of hook-and-loop type, though other fastener types are possible) located on the band <NUM> that are used to close and secure the band <NUM> around a patient's body part. In this embodiment, the balloon assembly <NUM> is inflatable via a connector and valve assembly <NUM> that is connected to an inlet <NUM> of the balloon assembly <NUM> for introduction of air into the balloon assembly <NUM> via a connection tubing <NUM>. In this embodiment, the connector and valve assembly <NUM> is comprised of a hard connector having an integrated connector port <NUM> that mates only with the complementary inflator tip <NUM> of an inflator <NUM>. In this embodiment, the inflator <NUM> comprises a collar <NUM> that surrounds the inflator tip <NUM> and prevents accidental or negligent misuse of the inflator <NUM>, for example any attempt to insert the inflator tip <NUM> directly into an introducer sheath used during a vascular access procedure.

<FIG> show a balloon assembly <NUM> according to another embodiment of the present invention, and <FIG> shows the balloon assembly <NUM> attached to a hemostasis device <NUM> having a band <NUM> that is attached around the arm <NUM> of a patient in the vicinity of the patient's wrist. <FIG> show a "side fold" design of the balloon assembly <NUM> which has a single, outer laser-welded perimeter that forms a channel <NUM> that connects a small balloon <NUM> and a large balloon <NUM> together in fluid flow communication. A connection tubing <NUM> enters the balloon assembly <NUM> via an inlet <NUM> that allows for introduction of air into the balloon assembly <NUM>. Via a single welding step, the folded balloon assembly <NUM> of the present embodiment creates a dual-balloon structure comprising the small balloon <NUM>, the large balloon <NUM>, and the integrated channel <NUM>, thereby achieving elimination of the welded connection port of the prior art devices. As shown in <FIG>, the balloon assembly <NUM> is completed by folding it about the fold line <NUM> to create a folded portion <NUM>, and such that a first portion of the channel <NUM> is placed atop a second portion of the channel. In this embodiment, the balloon assembly <NUM> is attached to the hemostasis device <NUM> via a single attachment hinge <NUM>, but in alternative embodiments a side fold balloon assembly design could have two separate attachment hinges by which the balloon assembly is attached to a hemostasis device. As shown in <FIG> and further described in detail below, a "breather" strip <NUM>, layer, or other component can optionally be included within the channel <NUM> to help prevent material adhesion between the two layers of the balloon assembly <NUM> or kinking of the channel <NUM>, thus reducing the likelihood that the channel <NUM> will fail to inflate, causing the balloon assembly <NUM> to fail.

In some embodiments according to the present invention, when the balloon assembly is attached to the band of the hemostasis device in its intended configuration, there is some possibility that the folded channel could become tightly creased such that airflow is all or partially kinked off between the balloons. In the various embodiments described herein, one or more pieces of secondary material can optionally be included within each channel to help hold the channel open. These "breather strips" may be one or more additional pieces of material included within the channel, which may be comprised of either air-permeable or air-impermeable materials. Alternatively, or in addition, the channel(s) can be partially held open along their edge(s) by creating height along the one or more perimeter(s) of the balloon assembly construction using: one or more additional layer(s) of material; a glue line; and/or an extruded bead or weld line resulting from a RF welding process, along the one or more perimeter(s).

<FIG> show a balloon assembly <NUM> according to another embodiment of the present invention, and <FIG> shows the balloon assembly <NUM> attached to a hemostasis device <NUM> having a band <NUM> that is attached around the arm <NUM> of a patient in the vicinity of the patient's wrist. <FIG> show a "center vent" folded design that is a form of end fold design in which an air channel <NUM> is created in the center of a side edge of the balloon assembly <NUM>. In this embodiment, the balloon assembly <NUM> has single, outer laser-welded perimeter that forms the single air channel <NUM> connecting a small balloon <NUM> and large balloon <NUM> together in fluid flow communication. In this embodiment, the remainder of the side edge that includes the air channel <NUM> is sealed and serves as an attachment hinge <NUM> for connecting the balloon assembly <NUM> to the hemostasis device <NUM>. A connection tubing <NUM> enters the balloon assembly <NUM> via an inlet <NUM> that allows for introduction of air into the balloon assembly <NUM>. Via a single welding step, the folded balloon assembly <NUM> of the present embodiment creates a dual-balloon structure comprising the small balloon <NUM>, the large balloon <NUM>, and the integrated channel <NUM>, thereby achieving elimination of the welded connection port of the prior art devices. As shown in <FIG>, the balloon assembly <NUM> is completed by folding it about the fold line <NUM> to create a folded portion <NUM>, and such that a first portion of the channel <NUM> is placed atop a second portion of the channel <NUM>. In this embodiment, the balloon assembly <NUM> is attached to the hemostasis device <NUM> via a single attachment hinge <NUM> that is located along the same edge of the balloon assembly <NUM> as the channel <NUM>. In alternative embodiments, a "center-vent" end-fold balloon assembly design could have one or two separate attachment hinges located on the edge of the balloon assembly <NUM> opposing the edge where the channel <NUM> is located (i.e., on the edges of the small balloon <NUM> and/or large balloon <NUM> shown on the right side in the view of <FIG>). In this embodiment, a breather strip <NUM> may be optionally included within the channel <NUM>.

<FIG> shows another embodiment of a balloon assembly <NUM> according to the present invention. In this embodiment, rather than a single folded balloon design with a direct, integral air channel, the balloon assembly <NUM> is formed of two separate balloons, a small balloon <NUM> and a large balloon <NUM>, that are not directly connected together in fluid flow communication via an integral channel. Instead, a Y-shaped connector <NUM> that has a single air inlet and two air outlets is used, with a first connection tubing <NUM> routed between one of the air outlets (not labeled) of the Y-shaped connector <NUM> and an inlet <NUM> on the large balloon <NUM> and a second connection tubing <NUM> routed between the other of the air outlets (not labeled) of the Y-shaped connector <NUM> and an inlet <NUM> of the small balloon <NUM>. In this embodiment, the balloon assembly <NUM> is attachable to a hemostasis device via a single attachment hinge <NUM>, but in alternative embodiments a multi-balloon assembly design with separated air input lines could have separate attachment hinges by which the balloon assembly is attached to a hemostasis device.

Rather than using connection tubing to feed air through an inlet that is located along a side edge of the balloon assembly, balloon assemblies according to the present invention could also utilize a "chimney"-style port that is routed perpendicularly to the surfaces of the balloon(s). <FIG> show, respectively, schematic views of a side-fold balloon assembly <NUM> and a "center-vent" end-fold balloon assembly <NUM>, which include respective chimney ports <NUM>,<NUM> that form the air inlet for the respective balloon assembly <NUM>,<NUM>. It should be understood that balloon assembly <NUM> is otherwise functionally similar to balloon assembly <NUM> of <FIG> and that balloon assembly <NUM> is otherwise functionally similar to balloon assembly <NUM> of <FIG>, with like parts in the embodiments of <FIG> labeled with reference numerals increased by a value of <NUM> with respect to the respective related embodiment.

While the embodiments discussed above are designed as two-balloon structures, additional folds or split air lines could be used to form a balloon assembly having any number of balloons or separate air chambers in accordance with the inventive concepts taught herein. Further, in accordance with any of the embodiments, structures, concepts, or methods taught herein, the channel(s) or air passages between the balloons could be of any number, could be of any non-linear shape (e.g., angled, zig-zagged, curved), and/or could split, combine, or both. In alternative embodiments, any connection tubing could be replaced by a "chimney port" or hose barb.

Another drawback with the structure of existing balloon assemblies is expansion defects or failures caused by the top and bottom layers of balloons adhering to another and failing to properly separate and permit the balloon to inflate after long periods of having been adjacent to another (i.e., after long periods of the balloon being uninflated). Referring now to <FIG>, a sectional view of a balloon assembly <NUM> according to the prior art is shown in an uninflated state, with a top layer <NUM> and a bottom layer <NUM> thereof shown adjacent to another with no air gap or space between the layers <NUM>,<NUM>.

In some embodiments according to the present invention, this expansion failure is addressed by including spacer(s), strip(s), and/or additional layer(s) of material between the top and bottom layers of the balloon, or otherwise forming space(s) between the layers of material. Materials can be added within formed air channel(s) to prevent these air paths from sealing off when the balloon assembly is folded. These "breather strips" are formed from air-permeable materials, including but not limited to felt, thread, paper, and porous plastic. In alternative embodiments, non-permeable materials can be placed such that they prop open air channel(s), thus allowing air to pass through the channel(s) adjacent to the material. Suitable non-permeable materials include but are not limited to tubing, stickers (adhesive backed paper), flexible sheets of either similar or dissimilar material to the material of the flexible sheet of the balloon, and/or cured glue. Holding channel(s) open at their edges via non-permeable materials, as shown in the example of <FIG> below, achieves the same effect as inserting air-permeable "breather strips" between layers of the balloon to form air channel(s). These space(s) may be located in the vicinity of the air injection port such that when air is injected into the balloon(s) the space serves as a trigger that helps peel apart any adhesions between the layers as air continues to flow into the balloon(s). Breather strips may be of any suitable cross-sectional shape, including but not limited to circular, oval, or rectangular.

<FIG> shows a sectional view of a balloon assembly <NUM> according to the present invention in an uninflated state, with a top layer <NUM> and a bottom layer <NUM> thereof shown mostly adjacent to another, but further including spacers <NUM>,<NUM> along the side edges (perimeter) of the balloon assembly <NUM> that introduce respective air gaps <NUM>,<NUM> adjacent to the spacers <NUM>,<NUM>, such that when air is introduced into the balloon assembly <NUM> between the top layer <NUM> and bottom layer <NUM>, the air gaps <NUM>,<NUM> created by the spacers <NUM>,<NUM> serve as air flow paths that promote proper inflation of the balloon assembly <NUM>, overcoming any adherence between the two layers <NUM>,<NUM>. It should be understood that the assembly shown in <FIG> could be representative of the entire cross-section of a balloon assembly, or instead of one channel of a multi-channel balloon assembly. It should further be understood that a spacer or third layer of material could be included around one edge (e.g., outer perimeter) of the assembly or channel, while another edge (e.g., inner perimeter) is comprised of only two material layers.

<FIG> schematically depict a balloon assembly <NUM> that includes one (or more) intermediate layer(s) used as spacer(s) between top and bottom layers thereof. <FIG> schematically depicts an unfolded balloon assembly <NUM> formed by bonding or laser welding a top layer <NUM>, middle layer <NUM>, and bottom layer <NUM> together via a weld line <NUM> located around an exterior perimeter of the balloon assembly <NUM>, and a weld line <NUM> located around an interior perimeter of the balloon assembly <NUM>, with the top layer <NUM> and bottom layer <NUM> welded (or bonded) together via the exterior weld line <NUM> at the perimeter (leaving space <NUM> for an air inlet), and the middle layer <NUM> welded (or bonded) to both of the top layer <NUM> and the bottom layer <NUM> via weld line <NUM> to act as a spacer therebetween (the squares projecting upwardly and downwardly from the middle layer <NUM> in <FIG> depict the weld/bonding locations to the respective layers <NUM>,<NUM>). The weld line <NUM> creates a pair of channels 916a,916b on either side thereof, such that when the balloon assembly <NUM> is folded about fold line <NUM> to form a completed balloon, air can travel through these channels 916a,916b between the two formed balloon chambers. The balloon assembly <NUM> of the present embodiment has both two- and three-layer portions, with the three-layer portions acting to prevent expansion failure in the remainder of the balloon assembly <NUM>. In this embodiment, once folded it is possible to cut out the interior area of the center welded area (the area inside weld line <NUM>), since this is not necessary for proper functioning of the balloon assembly <NUM>. By this method, an "end-fold" balloon assembly-similar to the balloon assembly <NUM> of <FIG>-is constructed.

Claim 1:
A balloon assembly (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>) for a hemostasis device (<NUM>, <NUM>, <NUM>, <NUM>), the balloon assembly (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>) comprising:
a first chamber (<NUM>);
a second chamber (<NUM>); and
at least one channel (134a-b, <NUM>, <NUM>, 916a-b) that is in fluid flow communication between the first chamber and the second chamber, wherein a single perimeter of attachment between a first layer of material and a second layer of material defines at least a portion of a perimeter of the first chamber, at least a portion of a perimeter of the second chamber, and at least a portion of a perimeter of the at least one channel (134a-b, <NUM>, <NUM>, 916a-b), characterized in that at least a portion of the first chamber overlays at least a portion of the second chamber, and in that the at least one channel is folded.