Patent Description:
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 methods of constructing hemostasis devices are also time-consuming and expensive. Accordingly, there is a need for improved methods that address these and other drawbacks of the prior art.

<CIT> discloses a tourniquet cuff having minimal flow restrictions within its pneumatic passageway under normal operating conditions.

<CIT> discloses an adjustable radial and ulnar vascular compression wristband assisting in achieving partial or full occlusion of a blood vessel when applied to a patient's wrist during or following a medical procedure. At least two adjustably inflatable non-adjacent balloons on the wristband apply preferential compression to portions of the circumference of the wrist, including in particular those portions overlying the ulnar and radial arteries.

<CIT> discloses a radial and ulnar compression band.

In order to solve the above-mentioned problem, the present invention provides a method according to 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. Unless specified, the specific order of step(s) recited in any method claim do not form a limitation of said claim.

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 methods of constructing improved balloon assemblies, each of which omit the connection port between the balloons. Several of the methods described herein include the steps of forming two or more balloon chambers and a connecting air channel via connecting two or more layers of material (e.g., vinyl or PVC) together about a single welded perimeter, and then folding the structure about a fold line to form a balloon assembly that includes the small balloon located atop the large balloon, with the folded, integral air channel routed between the two balloons. Said another way, the step of forming the two or more balloon chambers and the air channel that connects between the balloon chambers is done via a single welding or forming step to create a contiguous air chamber that includes the plurality of balloons and the air channel(s) that connect the plurality of balloon(s) together. In an alternative embodiment according to the present invention a plurality of balloons are formed separately, a multi-output connector having one air input is formed with inflation tubing split into the appropriate number of output connection tubes (e.g., a "Y"-shaped connector with one input and two outputs), and each of the individual output connection tubes is separately routed into a respective 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>, one embodiment of a balloon assembly <NUM> constructed according to a method of the present invention will be described in detail. The hemostasis devices shown in the Figures are generally designed to be wrapped and secured in place around the arm 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 be partially or entirely opaque.

<FIG> show various views of a balloon assembly <NUM> constructed according to a method of the present invention, and <FIG> show the balloon assembly <NUM> attached to an exemplary hemostasis device <NUM>. <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> (see also the balloon assembly formed through the method <NUM> of <FIG>). 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 flexible band or rigid insert plate), or omitted entirely.

<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 any suitable connector and valve assembly that is connectable to an inlet <NUM> of the balloon assembly <NUM> for introduction of air into the balloon assembly <NUM> via a connection tubing <NUM>.

While the embodiments discussed herein 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 concepts and methods 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.

There is some possibility that the folded channel(s) of each balloon assembly constructed according to methods of the present invention could become tightly creased when the balloon assembly is attached to the band of a hemostasis device in its intended configuration, such that airflow is all or partially kinked off between the balloons. According to the various method 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, and may be of any suitable shape (e.g., a circular or oval cross-sectional). 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). Various examples of constructing air channel(s) with and without breather strip(s) are shown in <FIG> and will be discussed in detail below.

Another drawback with existing methods of constructing two-layer balloon assemblies is resulting expansion defects or failures caused by the top and bottom layers of material adhering to another and failing to properly separate to permit the balloon(s) to inflate after long periods of having been adjacent to another (i.e., after long periods of the balloon(s) being uninflated). Referring now to <FIG>, a sectional view of a balloon assembly <NUM> constructed according to a prior art method 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 this prior art embodiment, the entirety of the two layers <NUM>,<NUM> are adjacent each other, with no gaps or spaces between the two layers <NUM>,<NUM> to assist in separation of the two layers <NUM>,<NUM> as air is introduced into the balloon assembly <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 examples 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> constructed according to a method of 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 (inner periphery) of the balloon assembly <NUM> that introduce 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>. In this embodiment, the spacers <NUM>,<NUM> are formed of one or more intermediate layers of material that are placed and welded or bonded between the top layer <NUM> and bottom layer <NUM>.

Many materials and methods could be used to create appropriate space between layers of a balloon assembly in order to prevent expansion failures. One method <NUM> of making a two-layered balloon assembly including appropriate spaces about the edges, as shown in <FIG> above, includes the steps of: (<NUM>) depositing a first layer (inner line) of glue <NUM> on a bottom sheet <NUM> while leaving a space <NUM> to form an air inlet <NUM> (see <FIG>); (<NUM>) curing the first layer (inner line) of glue <NUM> to create a perimeter (see <FIG>); (<NUM>) depositing a second layer (outer line) of glue <NUM> on the bottom sheet <NUM> just to the outside of the first layer (inner line) of glue <NUM> (see <FIG>); (<NUM>) placing a top sheet <NUM> on top of the first and second glue layers <NUM>,<NUM> and bottom sheet <NUM>, which results in the uncured second layer (outer line) of glue <NUM> spreading outwardly away from the first layer (inner line) of glue <NUM> (see <FIG>); (<NUM>) inserting a piece of connection tubing <NUM> into the formed inlet <NUM> (see <FIG>); (<NUM>) spreading the glue around the exterior perimeter of the connection tubing <NUM>; (<NUM>) curing the second layer (outer line) of glue <NUM> to completely seal the two layers of material together around the deposited perimeter and inlet <NUM> (see <FIG>); and (<FIG>) cutting the sheets <NUM>,<NUM> to form an unfolded balloon assembly (see <FIG>). Thus, according to this method, the first layer (inner line) of glue <NUM> acts to space the bottom sheet <NUM> and top sheet <NUM> apart, preventing expansion failures. As shown in <FIG>, the constructed balloon assembly can then be folded along fold line <NUM> to form a two-chambered balloon assembly with a single weld perimeter and no connection port between the balloons. As shown in <FIG>, according to this method <NUM> a balloon assembly comprising a first chamber <NUM>, a second chamber <NUM>, and a channel <NUM> that connects the first and second chambers <NUM>,<NUM> together in fluid flow communication is formed.

Another method of creating appropriate space between layers of a balloon assembly is to use one or more intermediate layer(s) as spacer(s) between top and bottom layers of a balloon. One such method <NUM> and apparatus formed thereby is illustrated in <FIG>. In the step shown in <FIG>, a middle sheet <NUM> including an outline <NUM> for deposition of a glue layer thereon is cut and placed on a worksurface. In the Figures, the middle sheet <NUM> is schematically indicated by a fill pattern consisting of "upward" diagonal lines angled at <NUM> degrees from bottom left to top right. In the step shown in <FIG>, the middle sheet <NUM> is placed atop a bottom sheet <NUM> (which is schematically represented in the Figures by a fill pattern consisting of "downward" diagonal lines angled at <NUM> degrees from top left to bottom right). In the step shown in <FIG>, a first glue layer <NUM> (e.g., a UV glue) is then applied to the middle sheet <NUM>, following the outline <NUM> and leaving a space <NUM>. In <FIG>, the dotted fill within the first glue layer <NUM> indicates that the first glue layer <NUM> is uncured during this step. In the step shown in <FIG>, the first glue layer <NUM> is cured (the solid-fill used in <FIG> is used to indicate the cured first glue layer <NUM>'). In the step shown in <FIG>, the middle sheet <NUM> is cut, leaving a portion of an inlet <NUM> corresponding with the location of the space <NUM>. In the step shown in <FIG>, a second glue layer <NUM> (e.g., a UV glue) is applied around the perimeter of the cut middle sheet <NUM>, including around the opening of the inlet <NUM>. The dotted fill shown in <FIG> is used to depict that the second glue layer <NUM> is uncured during these steps. In the step shown in <FIG>, a connection tubing <NUM> is inserted within the inlet <NUM>, and in the step shown in <FIG>, the connection tubing <NUM> is rotated in one or both rotational direction(s) <NUM> to fully apply the uncured glue of the second glue layer <NUM> around the connection tubing <NUM> in the circumferential direction. In the step shown in <FIG>, a top sheet <NUM> is overlaid on top of the middle sheet <NUM>, the top sheet <NUM> being schematically represented in the figures via a fill pattern consisting of horizontal lines. In the step shown in <FIG>, the partial balloon assembly is flipped over so that the glue of the second glue layer <NUM> is properly applied to the top sheet <NUM>, and in the step shown in <FIG> the second glue layer <NUM> is cured (the cured second glue layer is designated <NUM>' in <FIG> and shown with a solid fill in <FIG>). If necessary, double-sided tape may be used in some of the steps shown in <FIG>, for example: the step shown in <FIG> to hold the middle sheet <NUM> in place atop the bottom sheet <NUM>; and in the step shown in <FIG> to hold the connection tubing <NUM> in place within the inlet <NUM> before curing of the UV glue.

<FIG> is a schematic view of an unfolded balloon assembly <NUM> formed according to the method <NUM> described above. <FIG> clearly shows the formed small balloon <NUM> and large balloon <NUM> connected together via an air channel <NUM> such that introduction of air into the inlet <NUM> via the connection tubing <NUM> will inflate both balloons <NUM>,<NUM>. In this embodiment, the unfolded balloon assembly <NUM> includes tabs <NUM>,<NUM> that permit for final assembly of the balloon assembly once it has been folded along fold line <NUM>, and these tabs <NUM>,<NUM> can serve as one or more attachment hinge(s) for connecting the completed balloon assembly to a hemostasis device (e.g., band or other closure device).

<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, that has been formed according to another method of the present invention. <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.

<FIG> show steps of yet another method <NUM> of constructing a balloon assembly in accordance with the present invention. It should be understood that the steps of the method <NUM> are shown schematically in <FIG>, and that certain parts of the structure (e.g., attachment tabs or hinges) are omitted from these figures for simplicity.

<FIG> shows the three separate sheets or layers of a balloon assembly <NUM> that will be constructed, prior to stacking and welding steps. In this embodiment, these layers consist of a bottom sheet <NUM>, a middle sheet <NUM>, and a top sheet <NUM>. The bottom sheet <NUM> comprises a printed indicator <NUM> that will be used to assist the clinician in proper alignment of the balloon assembly <NUM> in relation to a vascular access site where hemostasis is to occur, and the middle sheet <NUM> comprises a first cutout <NUM> that creates an outer perimeter of material and a central void and a second cutout <NUM> that is used to form part of an inlet <NUM> of the balloon assembly.

<FIG> shows a step of the method <NUM> where the three sheets <NUM>,<NUM>,<NUM> are stacked and welded together about an outer perimeter <NUM> and an inner perimeter <NUM> to form a welded sheet set <NUM>, prior to cutting. In the step shown in <FIG>, the (unfolded) balloon assembly <NUM> has been formed by cutting the three sheets just exterior to the outer perimeter (weld line) <NUM>, leaving an opening for the inlet <NUM>. In this embodiment the balloon assembly <NUM> has also been cut just interior to the inner perimeter (weld line) <NUM> to form an interior cutout <NUM>--as in the embodiment of a balloon assembly <NUM>--though this step may be omitted in alternative embodiments of the method <NUM>.

<FIG> show steps of a method <NUM> of constructing a hemostasis device including a folded balloon assembly in accordance with the present invention. In the step shown in <FIG>, an indicator is printed onto a bottom layer <NUM> of what will become a balloon assembly <NUM> (see <FIG>). In the step shown in <FIG>, one or more additional layer(s) of material are laser welded atop the bottom layer <NUM> such that the indicator <NUM> is interior to the perimeter of what will become the balloon assembly <NUM>, and a small balloon <NUM>, an attachment tab <NUM> adjacent to the small balloon <NUM>, a large balloon <NUM>, an attachment tab <NUM> adjacent to the large balloon <NUM>, and a pair of channels 534a,534b connecting the small balloon <NUM> and large balloon <NUM> together are formed. In the step shown in <FIG>, the two or more welded layers of material that form the unfolded balloon assembly <NUM> are die cut around the weld lines to form the separable, unfolded balloon assembly <NUM> shown. In the step shown in <FIG>, the attachment tab <NUM> that is connected to the small balloon <NUM> is laser welded to a material layer that will become a band <NUM> of a hemostasis device. In the step shown in <FIG>, the balloon assembly <NUM> is folded along a fold line <NUM> so that the large balloon <NUM> is placed atop the small balloon <NUM> (i.e., the large balloon <NUM> overlays the small balloon <NUM>), a first portion of the channel 534a is placed atop a second portion of the channel 534a, and a first portion of the channel 534b is placed atop a second portion of the channel 534b. In the step shown in <FIG>, the attachment tab <NUM> that is connected to the large balloon <NUM> is laser welded to the band <NUM>. In the step shown in <FIG>, complementary fastener patches (e.g., hook-and-loop patches) <NUM>,<NUM> are impulse welded to opposite ends of the band <NUM>. Finally, in the step shown in <FIG>, the band <NUM> is die cut into its final shape, including any comfort-enhancing features (e.g., to include scalloped or otherwise interrupted edges). It should be understood that alternative methods according to the steps discussed above are possible within the scope of the present invention, in which the construction method steps or order thereof are modified, as would be appreciated by a person having ordinary skill in the art.

As discussed above, various methods of forming a balloon assembly or air channel(s) thereof that include a breather strip or other gap-creating structure for reducing the risk of adhesion failures are contemplated according to the present invention. Each of <FIG> show schematic cross-sectional views of various balloon assemblies constructed according to methods of the present invention, taken along hypothetical line X-X of <FIG>, thus showing the cross-sectional area of a channel member for discussion purposes.

<FIG> shows a cross-sectional view of a glued or laser-welded balloon assembly or air channel of three-layer construction, without a breather strip. In this embodiment, the balloon assembly or air channel comprises a top layer <NUM>, a middle layer <NUM>, and a pair of spacers <NUM>,<NUM> in the form of weld or glue lines that are formed at the inner peripheral edges of the middle layer <NUM> via gluing or a laser welding process. Each of the spacers <NUM>,<NUM> creates a respective gap <NUM>,<NUM> between the top layer <NUM> and bottom layer <NUM> through which air can flow, thus reducing the likelihood of adhesion failures. Similarly, <FIG> shows a cross-sectional view of a glued or laser-welded balloon assembly or air channel of three-layer construction, but including a breather strip. In this embodiment, the balloon assembly or air channel comprises a top layer <NUM>, a middle layer <NUM>, and a pair of spacers <NUM>,<NUM> in the form of weld or glue lines that are formed at the inner peripheral edges of the middle layer <NUM> via gluing or a laser welding process. Each of the spacers <NUM>,<NUM> creates a respective gap <NUM>,<NUM> between the top layer <NUM> and bottom layer <NUM> through which air can flow, thus reducing the likelihood of adhesion failures. Further, in this embodiment a breather strip <NUM> is included within the air channel, thus creating additional gaps <NUM>,<NUM> located on either side of the breather strip <NUM>, further assisting in the reduction of risk of adhesion failure.

<FIG> shows a cross-sectional view of a balloon assembly or air channel of two-layer construction formed via a RF welding process, without a breather strip. In this embodiment, the balloon assembly or air channel comprises a top layer <NUM> and a bottom layer <NUM>. The RF welding process that is used to attach the top layer <NUM> to the bottom layer <NUM> creates a pair of weld lines <NUM>,<NUM>, adjacent to each of which respective gaps <NUM>,<NUM> are formed between the top layer <NUM> and bottom layer <NUM> through which air can flow, thus reducing the likelihood of adhesion failures. Similarly, <FIG> shows a cross-sectional view of a balloon assembly or air channel of two-layer construction formed via a RF welding process, but including a breather strip. In this embodiment, the balloon assembly or air channel comprises a top layer <NUM> and a bottom layer <NUM>. The RF welding process that is used to attach the top layer <NUM> to the bottom layer <NUM> creates a pair of weld lines <NUM>,<NUM>, adjacent to each of which respective gaps <NUM>,<NUM> are formed between the top layer <NUM> and bottom layer <NUM> through which air can flow, thus reducing the likelihood of adhesion failures. Further, in this embodiment a breather strip <NUM> is included within the air channel, thus creating additional gaps <NUM>,<NUM> located on either side of the breather strip <NUM>, further assisting in the reduction of risk of adhesion failure.

<FIG> shows a cross-sectional view of a balloon assembly or air channel of two-layer construction formed via a laser welding process, without a breather strip. In this embodiment, the balloon assembly or air channel comprises a top layer <NUM> and a bottom layer <NUM>, with no gap between the two layers <NUM>,<NUM> that can help to reduce the risk of adhesion failure between the two layers <NUM>,<NUM>. Some balloon assemblies according to the prior art are constructed in this fashion. <FIG>, on the other hand, shows a cross-sectional view of a balloon assembly or air channel of two-layer construction formed via a laser welding process, but including a breather strip <NUM> between a top layer <NUM> and bottom layer <NUM> of the construction, thus creating gaps <NUM>,<NUM> located on either side of the breather strip <NUM> that assist in the reduction of risk of adhes hemostasis device ion failure.

Claim 1:
A method of constructing a hemostasis device (<NUM>), the method comprising:
forming a balloon assembly (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>) by attaching a top layer (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>), of material, a bottom layer (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>) of material, and at least one intermediate layer (<NUM>, <NUM>, <NUM>) of material together about a perimeter to form at least a portion of a first chamber, the first chamber being inflatable, the at least one intermediate layer creating a gap (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>) between the top layer of material and the bottom layer of material adjacent to the perimeter; and
connecting the balloon assembly (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>) to a flexible band (<NUM>, <NUM>) that is attachable around a body part of a patient,
the forming step further comprising attaching the top layer of material, the bottom layer of material, and the at least one intermediate layer of material together about the perimeter to form the at least a portion of a first chamber (<NUM>), at least a portion of a second chamber (<NUM>), and at least a portion of at least one channel (134a, 134b, <NUM>, 534a, 534b), the at least one channel being in fluid flow communication between the first chamber and the second chamber, the first chamber, second chamber, and at least one channel forming a contiguous chamber;
the method further comprising locating at least a portion of the first chamber (<NUM>) such that it overlays at least a portion of the second chamber (<NUM>) and such that the at least one channel (134a, 134b, <NUM>, 534a, 534b) is folded.