Patent Description:
The present disclosure relates generally to the field of medical devices used to provide hemostasis at a vascular access puncture site. More particularly, some embodiments of the present disclosure relate to inflatable hemostasis devices used to provide hemostasis of the arteries of the wrist, hand and foot, including the distal radial artery, following vascular access. Alignment indicia associated with inflatable hemostasis devices and the use thereof are also disclosed herein. The document <CIT> describes a device for targeting force applied to a radial access puncture site, comprising a cuff, an inflatable balloon disposed over the radial access puncture site, and targeting indicia disposed on the inflatable balloon or a rigid or semi-rigid member. The document <CIT> describes a compression system for compression against a puncture site of a vessel in a patient, comprising a compression element, a tightening unit, the compression element being provided with a placement mark indicating where the compression element should be placed. The document <CIT> describes a radial artery compression device, comprising a partially transparent rigid frame, a partially transparent and flexible sheet that is coupled to the frame, and an inflatable chamber.

The written disclosure herein describes illustrative embodiments that are nonlimiting and non-exhaustive. Reference is made to certain of such illustrative embodiments that are depicted in the figures, in which:.

The present invention is defined by the features of the independent claims.

In some instances, medical procedures involve insertion of one or more elongate medical devices into the vasculature of a patient. Achieving hemostasis during and/or after an interventional procedure that involves puncturing an artery may present certain challenges. To facilitate hemostasis at an access site, pressure may be applied at or slightly upstream of the skin puncture site. Such pressure may prevent or reduce the leakage of blood from the arteriotomy site and promote hemostasis. The compression may be applied by a healthcare worker or by a hemostasis device, such as the hemostasis devices described herein. In some instances, hemostasis devices may comprise bands for securement of the device to a patient and a compression member to apply a pressure or compressive force to the puncture site.

In some instances, a method for applying compression to a puncture site is through an inflatable hemostasis device. An inflatable hemostasis device may comprise a transparent portion to facilitate alignment of the device and/or visual assessment of hemostasis. An inflatable hemostasis device may also comprise alignment indicia to facilitate alignment of an inflatable bladder over the puncture site. Depending on the location of the alignment indicia on the device, the effects of parallax may affect the ability of the practitioner to properly align the inflatable hemostasis device over the puncture site. The inflatable hemostasis device may be configured to reduce or limit the effects of parallax.

The components of the embodiments as generally described and illustrated in the figures herein can be arranged and designed in a wide variety of different configurations. While various aspects of the embodiments are presented in drawings, the drawings are not necessarily drawn to scale unless specifically indicated.

The phrase "coupled to" is broad enough to refer to any suitable coupling or other form of interaction between two or more entities, including mechanical and fluidic. Thus, two components may be coupled to each other even though they are not in direct contact with each other. The phrase "fluid communication" is used in its ordinary sense, and is broad enough to refer to arrangements in which a fluid (e.g., a gas or a liquid) can flow from one element to another element when the elements are in fluid communication with each other.

The terms "proximal" and "distal" are opposite directional terms. For example, the distal end of a device or component is the end of the component that is furthest from the practitioner during ordinary use. The proximal end refers to the opposite end, or the end nearest the practitioner during ordinary use.

The term "fluid" is used in its broadest sense, to refer to any fluid, including both liquids and gases as well as solutions, compounds, suspensions, etc., which generally behave as fluids.

The term "compression" is used to define a compressive force or pressure applied to a portion of patient over a specific area. The compression level may correlate to a pressure within an inflatable component of the device. The compression level may also correlate to a volumetric size or shape of an inflatable component.

The term "inflation" is defined as a volumetric condition of an expandable sealed container. An increase of inflation is analogous to an increase in fluid content with the container or to the volumetric size of an expandable container. The inflation fluid may be compressible or non-compressible. The inflation level may be may or may not be analogous to an internal pressure.

<FIG> provides a top view of an embodiment of an inflatable hemostasis device <NUM>. The hemostasis device <NUM> may comprise a compression member <NUM> and a securement system <NUM>. The securement system <NUM> may be coupled to the compression member <NUM> and be configured to facilitate a secure attachment of the compression member <NUM> over a puncture site. The hemostasis device <NUM> may be configured to provide compression to various locations on a patient and the securement system may be configured to secure the hemostasis device <NUM> to various portions of a patient's body such as a wrist, hand or foot.

The securement system <NUM> may comprise bands that wrap around a portion of the patient's body. There may be one, two, three, four or more bands. The bands may comprise any suitable releasable securement mechanism, such as a hook-and-loop material, pressure sensitive adhesives, buckles, magnets, snaps, clasps, etc. all of which are contemplated to be within the scope of this disclosure. The securement system <NUM> may be configured to provide lateral and longitudinal positional stability of the compression member <NUM> over a puncture site.

As stated above the hemostasis device <NUM> may comprise a compression member <NUM>. As illustrated in <FIG>, the compression member <NUM> is specifically configured to provide compression to the snuff box of the left hand. However, the compression member <NUM>, as described herein, may be considered generic. Said another way, the compression member <NUM> may be configured to provide compression to various locations on a patient such as a wrist, hand or foot.

The compression member <NUM> may be configured to provide compression over a specifically defined area of a patient. The compression member <NUM> may comprise a perimeter <NUM> of <FIG> having a plurality of sides. There may be three, four, five, six or more sides. The sides may be straight, concave or convex. The sides may be configured to facilitate coupling of the securement system <NUM> to any number of sides. The compression member <NUM> may comprise a symmetrical or non-symmetrical shape. The shape may be configured to correlate with the anatomy of a patient adjacent a puncture site. The shape may also facilitate proper alignment and placement of the hemostasis device <NUM>. Still again, the shape may facilitate desired aesthetic properties of the hemostasis device <NUM>. The compression member <NUM> may comprise components that are transparent or translucent.

<FIG> shows the compression member <NUM> having properties, features and characteristics consistent with the hemostasis device <NUM>. However, one of ordinary skill in the art having the benefit of this disclosure will understand that certain properties, features, and characteristics described herein are generic in nature and may apply to hemostasis devices configured to provide compression to any location on a patient and for any therapy where compression is beneficial.

As illustrated in <FIG> and <FIG>, the compression member <NUM> may comprise a top plate <NUM>, a bladder <NUM>, an inflation port <NUM>, and a location indicium <NUM>. The bladder <NUM> may be disposed on the bottom of the compression member <NUM> so as to be disposed adjacent the skin of a patient and provide compression to a puncture site. The bladder <NUM> may be coupled to the top plate <NUM> and in fluid communication with the inflation port <NUM>. The location indicium <NUM> may be disposed at any suitable location on the compression member <NUM>.

Referring now to <FIG>, the top plate <NUM> may be configured to convert tension in the securement system <NUM> to a downward force on the patient. The top plate <NUM> may be configured to provide a support for the bladder <NUM>. The top plate <NUM> may be flexible or semi-flexible so as to conform to the anatomy of a patient upon securement. The top plate <NUM> may also be rigid. The top plate <NUM> may comprise a substantially flat plate, and/or may comprise flat, curved, convex or concave portions. Further, the top plate <NUM> may be symmetrical or non-symmetrical. In the illustrated embodiment, the top plate <NUM> is coupled to the securement system <NUM>. The top plate <NUM> may comprise a perimeter <NUM> having a plurality of sides. There may be three, four, five, six or more sides. The sides may be straight, concave or convex. The sides may be configured to facilitate coupling of the securement system <NUM> to any number of sides. The top plate <NUM> may comprise at least one of a hole, slot, protrusion, etc. to facilitate coupling to the securement system <NUM>.

The top plate <NUM> may be configured to be anatomically compatible with a patient, such as avoiding uncomfortable contact points. The top plate <NUM> may also be configured to provide some level of compression without inflation of the bladder <NUM> such as comprising a convex portion on the bottom side thereof. The top plate <NUM> may comprise a compression portion <NUM> disposed above the bladder <NUM> and a non-compression portion <NUM>. In some embodiments, the compression portion <NUM> may comprise the entire top plate <NUM>. Additionally, in some embodiments, the non-compression portion <NUM> may comprise a viewing window through which a practitioner may visually observe at least a portion of the puncture site.

A bottom surface of the top plate <NUM> may comprise features such as protrusions, surface displacements, variations in thickness, position or alignment indicators, surface texturing, etc. to facilitate welding or bonding of the bladder <NUM> to the top plate <NUM>. A top surface of the top plate <NUM> may comprise features such as protrusions, surface displacements, variations in thickness, position or alignment indicators, surface texturing, etc. to facilitate welding or bonding of the inflation port <NUM> to the top plate <NUM>. The top plate <NUM> may comprise an orifice <NUM> extending through the top plate <NUM>.

The top plate <NUM> may be transparent or translucent such that the puncture site can be seen through the top plate <NUM> to facilitate alignment of the compression member <NUM> with the puncture site and assessment of hemostasis during treatment. The top plate <NUM> may be formed of any suitable flexible or semi-flexible material such as polyethylene, polypropylene, polyvinyl chloride, polyurethane, etc. or any suitable rigid material, such as polycarbonate, polystyrene, styrene copolymers, polyethylene terephthalate, acrylic, polyethylene, polypropylene, etc..

Referring again to <FIG>, the bladder <NUM> may be configured to extend downward from the top plate <NUM> upon inflation. The bladder <NUM> may be disposed on the bottom surface of the top plate <NUM> such that the top plate <NUM> prevents upward expansion of the bladder <NUM>. The bladder <NUM> may be configured to be in contact with a patient's skin and provide compression to a puncture site of a patient. The bladder <NUM> may be configured to contain a fluid and maintain an internal fluid pressure. The bladder <NUM> may be configured so that an internal fluid pressure within the bladder <NUM> and the compressive pressure applied to a patient over a specified area are equal or substantially equal. The bladder <NUM> may be configured to be inflatable and deflatable. The bladder <NUM> may be configured to provide compression to a puncture site over a predefined area or shape. The bladder may be configured to provide a predefined compression depth profile. In some circumstances, the compression area on a patient may be relatively large or small and the compression profile may be relatively deep or shallow defining a range of volumetric capacities for the bladder <NUM>. For example, in some embodiments, the maximum capacity of the bladder <NUM> may be between <NUM> and <NUM>, between <NUM> and <NUM>, or between <NUM> and <NUM>. In another embodiment, the maximum capacity may be between <NUM> and <NUM>, between <NUM> and <NUM>, between <NUM> and <NUM>, or between <NUM> and <NUM>.

The bladder <NUM> may comprise a flat sheet or a preformed <NUM>-dimensional shape. The bladder <NUM> may be flexible and non-stretchable or flexible and stretchable. The bladder <NUM> may be transparent or translucent to facilitate visible observation of a puncture site. The bladder <NUM> may be coupled to the top plate <NUM>. The bladder <NUM> may be sealably coupled to the top plate <NUM> along a perimeter of the bladder <NUM> such that a portion of the top plate <NUM> forms a top wall of the bladder <NUM>. The orifice <NUM> may be deposed within the perimeter of the bladder <NUM>.

The bladder <NUM> may be configured to define specific compression characteristics. Such characteristics may comprise the area, depth, and shape of the compression on a patient. <FIG> show orthogonal cross-sectional views of the compression member <NUM> with cut lines through an apex <NUM> of the bladder <NUM> when the bladder <NUM> is inflated. The apex <NUM> is defined as the point on the bladder <NUM> most distant from the top plate <NUM> when the bladder <NUM> is inflated. As illustrated, the bladder <NUM>, when inflated, defines a compression profile or volumetric shape. When inflated there may be an apex <NUM> of the bladder <NUM>. The location of the apex <NUM> may be centered within the perimeter of the bladder <NUM>. The location of the apex <NUM> may be offset from the center of the bladder <NUM>. The location of the apex <NUM> may be predetermined by the characteristics of a preform of the bladder <NUM>. Such characteristics may comprise thickness variation and/or three-dimensional shape. The bladder <NUM> may comprise a thick portion to facilitate a relatively flat or uniform compression area on a patient. The bladder <NUM> may comprise preformed folds, such as a bellows arrangement, to facilitate a predefined compression depth and/or profile. The preform of the bladder <NUM> may also facilitate the manufacturing processes of the compression member <NUM>, e.g. printing of an indicium <NUM> on an inner surface of the bladder <NUM>. The preform of the bladder <NUM> may also facilitate a desired position of the indicium <NUM> relative to a perimeter of the top plate <NUM> when the bladder <NUM> is in an uninflated state. The bladder <NUM> may be formed from any suitable, flexible, transparent or translucent material, such as polyethylene, polypropylene, polyurethane, etc..

Referring again to <FIG>, the inflation port <NUM> may be in fluid communication with the bladder <NUM>. The inflation port <NUM> may be coupled to the top plate <NUM> such that the inflation port <NUM> is in fluid communication with the orifice <NUM>. As such, fluid communication between the inflation port <NUM> and the bladder <NUM> may comprise the orifice <NUM>. The inflation port <NUM> may be disposed toward an outer perimeter of the bladder <NUM> such that the inflation port <NUM> does not obstruct visualization of the puncture site. The inflation port <NUM> may be disposed on a line bisecting the top plate <NUM>. <FIG> show the inflation port <NUM> oriented perpendicular to the top plate <NUM>. However, the inflation port <NUM> may be coupled at any angle relative to an axis perpendicular to the top plate <NUM>. The inflation port <NUM> may comprise a valve to provide for inflation and deflation of the bladder <NUM> and containment of fluid pressure within the bladder <NUM>. The inflation port <NUM> may be configured to be releasably coupleable to a fluid displacement device, such as a syringe.

<FIG> shows several potential embodiments of patterns for the location indicium <NUM>. The illustration of <FIG> is non-inclusive and any and all other indicia comprising dots, line segments, curves, circles, polygons, contour lines, arrows, crosses, etc. and any combination thereof that may be configured for alignment purposes are within the scope of this disclosure. The location indicium <NUM> may comprise a point component so as to facilitate two-dimensional alignment of the compression member <NUM> on the puncture site. The indicium <NUM> may comprise at least one linear component to facilitate rotational alignment with a linear aspect of the patient such as an artery. Additionally or alternatively, the indicium <NUM> may comprise at least one directional component such as an arrow. The directional component may be used to rotationally align the compression member <NUM> with a specific directional aspect of a patient such as blood flow direction through an artery. The location indicium <NUM> may comprise one, two or all three components of alignment as described above. Additional location indicia may also be disposed on the compression member <NUM> and may comprise one, two or all three components of alignment as described above.

The location indicium <NUM> may also indicate an area, shape and/or depth profile of the compression applied to the patient. The location indicium <NUM> may also comprise contour lines or other components to indicate a concentric or non-concentric depth profile.

The location indicium <NUM> may comprise a sequence of two or more components. The sequence may define one or more predetermined distances or lengths, such as graduation marks. The sequence of two or more components may correlate with multiple point locations on a patient, such as a skin puncture site and an arteriotomy site.

The location indicium <NUM> may be disposed on the bladder <NUM>. In some embodiments, the location indicium <NUM> may be disposed on an inner surface of the bladder <NUM> as shown in <FIG>. Disposition of the location indicium <NUM> on the inner surface of the bladder <NUM> may provide protection from being inadvertently removed or otherwise damaged through physical contact and/or chemical contact, e.g. with cleaning agents. The patient may also be protected from contact with the location indicium <NUM> such as printing chemicals, surface roughness, etc..

The location indicium <NUM> may be disposed adjacent a center location of the bladder <NUM>. The location indicium <NUM> may be disposed adjacent the apex <NUM> of the bladder <NUM>. The location indicium <NUM> may be disposed a distance O offset from the center and/or the apex <NUM> of the bladder <NUM> as shown in <FIG>. The offset distance may correlate to the distance between the skin puncture site and the arteriotomy site or may correlate to other marks on a patient's skin.

Alignment of the compression member <NUM> with the puncture site on a patient may facilitate hemostasis. Alignment may be facilitated by viewing the puncture site through a transparent or translucent top plate <NUM> and/or bladder <NUM>. Alignment may be further facilitated by visually aligning the location indicium <NUM> with the puncture site. In some instances, aligning the location indicium <NUM> disposed on the compression member <NUM> with a puncture site on a patient may need to take into account parallax.

illustrates the effects of parallax as may be applicable to inflatable hemostasis devices. A location indicium LI is shown disposed a height H above the skin surface S of a patient. A normal viewing position V1, i.e. normal to a top plate TP, defines a projected indicium location P1 on the skin surface S. A second viewing position V2, angularly offset from V1 by an angle α, defines a second projected indicium location P2 on the skin surface S. The distance D between P1 and P2 may be approximated by the equation D = H X Tangent(α). Patient anatomy, position of the puncture site and patient movement may all contribute to a wide variation in viewing angles α relative to an axis normal to the top plate TP. The location indicium LI may also be disposed at a significant height H above the skin surface S. These two factors may result in misalignment of the indicium LI relative to a puncture site on a patient even when alignment may visually appear to be correct. For example, an angular difference α of <NUM> degrees and a height H of <NUM> may combine to produce a distance D approaching <NUM> between the two projected indicium locations P1, P2 on the skin S. In some instances, a miss-alignment distance may cause insufficient compression to a puncture site. Hence, a reduction in the parallax effect may facilitate compression of a puncture site. For a second example, an included angle α of <NUM> degrees between two viewing positions V1, V2 and a height H of <NUM> may combine to produce a distance D approaching <NUM> between two projected indicium locations P1, P2 on the skin S when neither of the viewing angles are normal to the top plate TP.

The inflatable hemostasis device <NUM> may be configured to limit the parallax effect (distance D). For example, compression member <NUM> may be configured to limit the parallax distance D as described above for a viewing angle α of <NUM> degrees to <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> or less. The parallax effect may be reduced by reducing the height H. In certain instances reducing the height H by disposition of the location indicium <NUM> on the inner surface of the bladder <NUM> may reduce the parallax effect. The bladder <NUM> may be adjacent to or in direct contact with the patient's skin when inflated, thereby positioning the location indicium adjacent the skin. Disposition of the location indicium <NUM> on the inner surface of the bladder <NUM>, may limit the parallax effect D to be equivalent to the thickness of the bladder <NUM> when viewed from a <NUM> degree viewing angle.

In some instances, minimizing the parallax effect when the hemostasis devise <NUM> is initially placed on the patient so that initial alignment of the indicium <NUM> with the puncture site is correct may facilitate hemostasis. The bladder <NUM> may be partially inflated or otherwise configured to be significantly close to or in contact with the skin of the patient upon initial placement of the compression member <NUM> on the patient. The top plate <NUM> and/or bladder <NUM> may be configured to dispose the bladder <NUM> close to or in contact with the skin of the patient when uninflated.

<FIG> shows an exploded view of the compression member <NUM>. A manufacturing process of the compression member <NUM> may comprise sealably coupling the inflation port <NUM> to the top surface of the top plate <NUM> and sealably coupling the bladder <NUM> along the perimeter thereof to the bottom surface of the top plate <NUM>. Methods of coupling inflation port <NUM> to the top surface of the top plate <NUM> and the bladder <NUM> to the bottom surface of the top plate <NUM> may comprise ultra-sonic welding, radio frequency welding, solvent bonding, boding with adhesives, etc..

The manufacturing process may also comprise placement of the location indicium <NUM> on the inner surface of the bladder <NUM> prior to coupling the bladder <NUM> to the top plate <NUM>. The process of placing the location indicium <NUM> on the bladder <NUM> may comprise altering the visible properties of the bladder <NUM> during or after the forming process of the bladder <NUM> which altering may comprise the forming of protrusions or recesses, surface texturing, laser marking, chemical etching, heat staking, etc. The process of placing the location indicium <NUM> on the bladder <NUM> may comprise adding a visible component, e.g. a label, or a visible substance, e.g. ink, to the inner or outer surface of the bladder <NUM>. The process of applying the location indicium <NUM> to the bladder <NUM> may comprise preparing the surface prior to applying the component or substance thereto. Such preparing may comprise wiping the surface with a cleaning or degreasing agent such as isopropyl alcohol, removing static charge, applying a primer, etching or otherwise altering the surface finish, etc. The process of adding a visible substance may comprise pad printing, ink jet printing, screen printing, laser marking, UV marking, thermal transfer printing, etc..

The process of placing the location indicium <NUM> on the bladder <NUM> may comprise initially determining the position for the location indicium <NUM> on the bladder <NUM>. The determining process may include identifying the apex <NUM> of the bladder <NUM> when inflated and thereafter, using the identified apex <NUM> as a reference point for the position of the location indicium <NUM>. The positioning of the location indicium <NUM> relative to the apex <NUM> may comprise assessment of at least one of the distance between the arteriotomy site and the puncture site, depth of the compression, shape of the bladder <NUM> when inflated, shape of the preform of the bladder <NUM>, direction of blood flow through an artery, etc..

The manufacturing process of the compression member <NUM> may also comprise adding or removing fluid from the bladder <NUM> after coupling the bladder <NUM> and the inflation port <NUM> to the top plate <NUM>. The manufacturing process of the inflatable hemostasis device <NUM> may further comprise coupling the compression member <NUM> to a securement system <NUM>.

<FIG> show various stages of the compression member <NUM> in use. <FIG> is a top view of a portion of a patient comprising a vascular access site. <FIG> shows a puncture site PS on the skin surface, an artery AR beneath the skin surface, blood flow direction F and an arteriotomy site AS. The arteriotomy site AS is shown at a length L upstream, i.e. opposite the direction of blood flow F, of the skin puncture site PS.

<FIG> is a top view of the compression member <NUM> disposed on the portion of a patient shown in <FIG>. Inflation port <NUM> is shown not obstructing the view of the puncture site PS. Also shown is the location indicium <NUM> aligned adjacent the skin puncture site PS. <FIG> is a cross-sectional side view of the illustration of <FIG>. <FIG> shows an uninflated bladder <NUM> disposed adjacent the skin surface S and the location indicium <NUM> aligned adjacent the skin puncture site PS. <FIG> shows the illustration of <FIG> with the bladder <NUM> inflated. Compression of the patient's skin and artery AR is shown. The location indicium <NUM> is shown adjacent the skin puncture site PS and the apex <NUM> of the inflated bladder <NUM> is shown adjacent the arteriotomy site AS. In other embodiments, the indicium may extend over both the skin puncture site and the arteriotomy site.

The method of use may comprise the steps or processes described below. A vascular access catheter or needle may be initially present prior to use of the inflatable hemostasis device <NUM> comprising the compression member <NUM>. The bladder <NUM> may be initially uninflated, partially inflated, or substantially fully inflated, or the bladder <NUM> may contain a vacuum. The practitioner may adjust the level of inflation of the bladder <NUM> prior to placing the compression member <NUM> on the patient. For example, the practitioner may partially inflate the bladder <NUM> so that the indicium <NUM> disposed on the bladder <NUM> is adjacent the skin of the patient. As illustrated in <FIG> and <FIG>, the practitioner may place the compression member <NUM> on the patient and align the location indicium <NUM> with the skin puncture site PS or the practitioner may align the location indicium <NUM> offset a predefined distance from the skin puncture site PS. The practitioner may rotationally align the compression member <NUM> with a longitudinal axis of the artery and the direction of blood flow F. At this stage, the bladder <NUM> may be uninflated, partially inflated, substantially fully inflated or contain a vacuum. The practitioner may secure the compression member <NUM> to the patient using the securement system <NUM> as shown in <FIG>. The practitioner may adjust the level of inflation in the bladder <NUM> after securement so as to prevent bleeding. The practitioner may assess alignment of the compression member <NUM> after securement and adjust the positional or rotational alignment. The practitioner may adjust the level of inflation of the bladder <NUM> according to a predetermined protocol or in response to a patient condition such as discomfort, bleeding, etc. Once hemostasis is achieved, the securement system <NUM> may be disabled and the compression member <NUM> removed.

Any methods disclosed herein include one or more steps or actions for performing the described method. The method steps and/or actions may be interchanged with one another. In other words, unless a specific order of steps or actions is required for proper operation of the embodiment, the order and/or use of specific steps and/or actions may be modified. Moreover, sub-routines or only a portion of a method described herein may be a separate method within the scope of this disclosure. Stated otherwise, some methods may include only a portion of the steps described in a more detailed method.

<FIG> and <FIG> show a second embodiment of a hemostasis device <NUM> that resembles the hemostasis device <NUM> described above in certain respects. Accordingly, like features are designated with like reference numerals, with the leading digits incremented to "<NUM>. " For example, the embodiment depicted in <FIG> and <FIG> includes a compression member <NUM> that may, in some respects, resemble the compression member <NUM> of <FIG> and <FIG>. Relevant disclosure set forth above regarding similarly identified features thus may not be repeated hereafter. Moreover, specific features of the hemostasis device <NUM> and related components shown in <FIG> may not be shown or identified by a reference numeral in the drawings or specifically discussed in the written description that follows <FIG> and <FIG>. However, such features may clearly be the same, or substantially the same, as features depicted in other embodiments and/or described with respect to such embodiments. Accordingly, the relevant descriptions of such features apply equally to the features of the hemostasis device <NUM> and related components depicted in <FIG> and <FIG>. Any suitable combination of the features, and variations of the same, described with respect to the hemostasis device <NUM> and related components illustrated in <FIG>, <FIG> can be employed with the hemostasis device <NUM> and related components of <FIG> and <FIG>, and vice versa.

<FIG> is a top view of a second embodiment of a vascular access hemostasis device <NUM> configured to provide compression to the radial artery of a patient. The hemostasis device <NUM> comprises a securement system <NUM> and a compression member <NUM>. The securement system <NUM> comprises two bands and may be configured to be secured to the wrist of a patient. The securement system <NUM> is coupled to the compression member <NUM>. The compression member <NUM>, as shown in <FIG>, is specifically configured to provide compression to the radial artery of a patient. However, the compression member <NUM> as described herein may be considered generic. Said another way, the compression member <NUM> may be configured to provide compression to other various locations on a patient, such as a wrist, hand, or foot. The compression member <NUM> may comprise a top plate <NUM>, a bladder <NUM>, an inflation port <NUM>, a location indicium <NUM>, and an inflation tube <NUM>. The top plate <NUM> is shown partially cut out in <FIG> to show the location indicium <NUM> disposed on an inner surface of the bladder <NUM>. The inflation tube <NUM> may be in fluid communication with the bladder <NUM> at one end. The inflation tube <NUM> may be coupled to and in fluid communication with the inflation port <NUM> at another end. The inflation tube <NUM> may also be coupled to the top plate <NUM> at one or more locations. The inflation tube <NUM> may in fluid communication with an orifice (not shown) extending through the top plate <NUM>.

<FIG> is a perspective view of the compression member <NUM>. The top plate <NUM> may be rigid and may be non-flat as shown in <FIG> The top plate <NUM> may comprise curvature to fit partially around a patient's wrist or other portion of a patient. The curvature of the top plate <NUM> may also be configured to provide alignment of the bladder <NUM> with a puncture site. The bladder <NUM> is shown in an inflated state. The location indicium <NUM> as shown may be disposed on an inner surface of the bladder <NUM>.

Claim 1:
An inflatable hemostasis device (<NUM>; <NUM>), comprising:
a top plate (<NUM>; <NUM>); and
a bladder (<NUM>; <NUM>) sealably coupled to the top plate along a perimeter of the bladder,
wherein the bladder (<NUM>; <NUM>) comprises an apex (<NUM>) when inflated and a location indicium (<NUM>; <NUM>) comprising a first portion linearly offset from the apex and configured to be positioned over a skin puncture site (PS), characterised in that the location indicium (<NUM>; <NUM>) further comprises a second portion disposed adjacent the apex and configured to be positioned over an arteriotomy (AS), and a third portion disposed between the first portion and the second portion and configured to axially align the bladder with an artery (AR).