Patent Publication Number: US-9427239-B2

Title: Apparatus and method of use for an adjustable radial and ulnar compression wristband

Description:
This Non-Provisional Utility Patent Application claims benefit of Provisional Patent Application No. 61/957,817, which has a filing date of Jul. 12, 2013, and Provisional Patent Application No. 61/976,978, which has a filing date of Apr. 8, 2014. 
    
    
     FIELD OF THE INVENTION 
     The present invention generally relates to compression devices for occluding blood flow through blood vessels in a limb, in particular, the radial and ulnar blood vessels located in a human forearm and wrist. More particularly, the invention relates to a device for reducing or stopping blood flow in said blood vessels by means of adjustably applying compression to the body surface overlying said blood vessels, for the purpose of achieving post-procedure hemostasis at a vascular puncture site used to gain access for catheters or other cannulae to the circulatory system. 
     BACKGROUND OF THE INVENTION 
     A number of devices have been utilized to externally compress blood vessels in various parts of the body to reduce or stop the flow of blood through said vessels in order to achieve post-procedure vascular hemostasis. Such devices generally find use in clinical settings, e.g. cardiac catheterization laboratories where minimally invasive procedures are performed on patients, e.g. catheterization of coronary arteries by means of vascular access using catheters inserted through sheaths placed into vascular puncture sites and arteriotomies. Such puncture sites are typically located in an artery close to the patient&#39;s skin surface, e.g. a femoral artery in the groin area or radial artery in the wrist area. At the end of these procedures when the catheters and sheath are to be withdrawn, devices that externally compress blood vessels are often used to achieve hemostasis at the puncture site and arteriotomy. Also used is manual compression, i.e. external compression applied by an operator&#39;s hands or fingers. 
     Sometimes used in conjunction with such external compression are hemostatic agents, which assist in achieving hemostasis of a puncture site. Examples of such hemostatic agents are powders, and “patches” or pads in various shapes, generally composed of: i) a chitosan or other polysaccharide such as a β-(1-4)-linked D-glucosamine (deacetylated unit) or N-acetyl-D-glucosamine, ii) thrombin, iii) calcium alginate, or iv) minerals such as kaolin or potassium ferrate. Applied to a puncture site and in contact with an amount of blood, these agents can assist in the formation of a clot to accelerate the time to hemostasis. 
     Several devices, which are known to the inventor, help achieve hemostasis in blood vessels of the forearm using mechanical and/or pneumatic means of applying compression over a blood vessel, for the purpose of allowing a clot to form, thereby enabling hemostasis and corollary cessation of bleeding. Features noted in this art are: i) the use of clamping or inflatable bladder mechanisms to selectively apply compression to those portions of the body surface overlying a target blood vessel and ii) the incorporation of features to gradually reduce compression and permit direct visual observation of a surface wound or puncture site leading to the target vessel. 
     The prior art teaches that compression applied externally, i.e. on the body surface and over a target blood vessel, slows the blood flow such that a clot can form so that normal hemostasis may occur. The prior art further teaches the value of: i) visual and physical access to the puncture or wound site on the body surface; ii) preferential and adjustable compression over a target vessel, so that arterial flow to or venous return from an extremity, for example a hand, are important attributes of a device having the purpose of achieving hemostasis following catheterization or other cannulation; iii) quickly releasing compression and removing the device from the patient; iv) enabling distal blood flow through adjacent blood vessels, for example, distal blood flow through the ulnar artery and venous return from the hand, while compression over the target vessel is applied; and, v) enabling distal blood flow through the target blood vessel while compression is applied to it. 
     The term “patent hemostasis” has been coined and was initially described by Samir Pancholy, MD in the PROPHET Study of 2007, where continued perfusion through the radial artery during the period in which external compression is applied for the purpose of achieving hemostasis at the arteriotomy and puncture site is required in order to reduce the incidence of chronic radial artery occlusion, a not-uncommon complication of radial access. He demonstrated that maintaining patency of the radial artery during the hemostasis period and adjusting compression to permit such patent hemostasis helps to avoid chronic radial artery occlusion. 
     Recently, medical discoveries (Bernat I, et al, “Efficacy and safety of transient ulnar artery compression to recanalize acute radial artery occlusion after transradial catheterization,” American Journal of Cardiology, 2011 June 1;107(11):1698-701. doi: 10.1016/j.amjcard.2011.01.056. Epub 2011 Mar. 23) regarding thrombosis resulting from accessing the radial artery for catheterization have shown an advantage to applying compression over the ulnar artery immediately post-procedure for patients in whom the radial artery is occluded, while avoiding bleeding from the radial puncture site. Achieving simultaneous compression of the ulnar artery during radial artery hemostasis in this fashion was performed using either a second device or applying manual compression (i.e. with the operator&#39;s fingers) over the ulnar artery. It&#39;s also expected that ulnar compression concomitant with compression over the radial artery for the purpose of achieving hemostasis will result in easier achievement of patent hemostasis in a substantial proportion of patients. Although many compression devices are available for compression of the radial artery there are none known to the inventor that can also simultaneously provide compression of the ulnar artery. 
     A pneumatically-adjustable device called the TR Band marketed by Terumo, as described in U.S. Pat. No. 7,498,477 by Wada, utilizes a wrist-encircling strap that applies compression by means of two inflatable bladders, one of which directly underlies the other, both for the purpose of compressing only the radial artery. The TR Band is initially attached to the patient using hook and loop fastening after positioning the bladders over the radial artery puncture site; a syringe is then attached to a tube connected to both bladders and air is injected to expand the bladders, thereby applying compression over the puncture site to achieve hemostasis when the sheath is pulled from the vessel. Air can then be gradually withdrawn from the bladders to usually enable patent hemostasis, i.e. blood flow through the radial artery without any bleeding from the arteriotomy and puncture site. The TR Band has no bladder or other compression means to apply compression over the ulnar artery. 
     Additional attributes of the TR Band include the feature whereby compression over the radial artery during deployment, caused by inflation of the bladders, automatically reduces during deployment without action by the user, through material stretching or automatic release of some of the volume of air contained in the bladders. Anecdotal evidence suggests that this is an undesirable feature if the deflation is excessive, at least when patients on which it is deployed have been administered anti-coagulation medications and/or are hypertensive, both of which are not-uncommon occurrences in cardiac catheterization patients. Such automatic deflation sometimes has the effect of reducing compression to the point that bleeding occurs at the puncture because insufficient compression is applied to stop said bleeding. 
     Another pneumatically-adjustable compression device is described by Egnelov in U.S. Pat. No. 6,264,673, which is more commonly known by its trade name of Femostop. Comprising a single rigid beam to which two pneumatically inflatable pressure pads and a belt are attached, it is designed specifically to apply compression to either femoral arteries or femoral veins for the simultaneous bilateral compression of said arteries or veins for the purpose of simultaneously providing hemostasis to each of two bilaterally-located puncture sites, one in each artery or vein. Models are also available for puncture sites on only one side of the patient. 
     Other devices in common usage include the Rad   AR    Vascular Compression Device as described by Niemeyer in abandoned U.S. Pat Appl. No. 61/198,956. The Rad   AR    device also applies adjustable compression, however such compression is modulated by mechanical and not pneumatic means. Another device is described by Niemeyer et al in pending U.S. patent application Ser. No. 14/227,160, where the adjustment means is achieved by a double ratcheting action. Another device is the HemoBand, described in U.S. Pat. No. 5,269,803 by Geary that discloses a strap that encircles the forearm with a pressure pad that applies compression over the vessel to prevent bleeding through the puncture. Other mechanically (as compared with pneumatically) operated devices that include a strap to prevent bleeding through a puncture site include: U.S. Pat. No. 4,182,338 to Stanulis; U.S. Pat. No. 4,005,709 by Laerdal; U.S. Pat. No. 3,954,109 by Patel; and U.S. Pat. No. 3,586,001 by Sanderson. Another device that includes a hemostat is the D-Stat Radial, from Vascular Solutions, Inc. Of these mechanical devices, only the Niemeyer devices enable easy adjustment, and none feature any compression means to provide simultaneous compression over the ulnar artery during radial artery compression. 
     Therefore, a need exists for an adjustable radial and ulnar compression wristband. Such a device is described in the U.S. Provisional Patent Applications No. 61/957,817 filed on Jul. 12, 2013 and No. 61/976,978 filed on Apr. 8, 2014 by Philip Benz, an inventor on this present non-provisional application. 
     SUMMARY AND OBJECTS OF THE INVENTION 
     The present invention generally relates to devices for use following cannulation procedures performed on blood vessels in a limb of a patient, in particular on the radial and ulnar arteries, during or after radial artery catheterization procedures. The &#39;817 and &#39;978 provisional utility patent applications by Benz describe an adjustable vascular compression wristband which applies adjustable compression on a patient&#39;s body surface overlying the radial and ulnar arteries thereby constricting, to varying degree, said arteries for the purpose of reducing or stopping blood flow at those points of compression, to permit hemostasis to occur at the target vessel puncture site and arteriotomy. Such compression is applied such that blood flow in the target vessel, i.e. the radial artery, is reduced or stopped at both the puncture site and at the arteriotomy, the compression being applied and adjusted independently for the ulnar artery as well as the radial artery. Thus, the invention of &#39;817 and &#39;978 provides utility in assisting with hemostasis following medical cannulation procedures on the limbs of a patient, in particular in radial artery catheterization procedures for interventional cardiology, diagnostic cardiology, radiology, and other cardiac and vascular procedures when catheters, sheaths or other cannulae are withdrawn from a patient&#39;s blood vessels. 
     The radial and ulnar compression wristband of the &#39;817 and &#39;978 invention has features that permit sufficient adjustable compression to be applied to the target blood vessels in a patient&#39;s forearm, specifically the radial and ulnar arteries while, at the discretion of the user deploying the device on a patient, maintaining blood flow through these target vessels. For example, the wristband may be used to simultaneously partially or fully occlude blood flow through radial and ulnar arteries, with compression adjustments to gradually increase blood flow as hemostasis occurs, while simultaneously permitting venous return from the hand. As described in &#39;817 and &#39;978, an inflation means is used to apply such compression, an adjustment means is used to adjust said compression in small increments, and a securement means is used to quickly attach and detach the device from the patient&#39;s wrist. 
     The wristband may be formed of biocompatible materials that may be assembled, packaged and pre-sterilized for single-use applications. Alternatively, the wristband may be provided in partially assembled or non-sterilized form. 
     In view of the above, an object of the adjustable vascular compression wristband of the present invention is to provide a device that provides external compression onto a body surface, which in turn compresses underlying target blood vessels for the purpose of slowing or stopping blood flow to assist in achieving hemostasis of a puncture or wound. 
     Another object of the present invention is to enable the device to be rapidly applied and fastened to the patient and, following use, rapidly removed from the patient. 
     Another object of the present invention is to enable a user operating the device to make fine adjustments in the amount of external compression applied to the target blood vessels following device deployment without releasing the fastening mechanism, the adjustments preferably being made independently for each vessel. 
     Another object of the present invention is to provide a user with both visual and physical access to the puncture site when the compression device is applied to the patient. 
     Another more particular object of the present invention is to adjustably provide external compression of target blood vessels, specifically the radial and ulnar arteries in the wrist following a catheterization or other medical cannulation procedure, directly over or near to a puncture site on the body surface, which leads to an arteriotomy, for the purpose of stopping or slowing distal blood flow in order to comfortably achieve hemostasis in the artery used to achieve vascular access. 
     Another more particular object of the present invention is to provide adjustable external compression of the target blood vessels while permitting patent hemostasis to occur in the radial artery, or alternatively in the event that the ulnar artery is used for vascular access, in the ulnar artery. 
     The wristband of the present invention achieves these and other objects through its inclusion of elements that generally include at least a flexible strap, a securement means for fastening said strap circumferentially around a wrist or forearm, a compression means for applying preferential compression to the surface of a wrist or forearm, more particularly comprising an inflation means for achieving said compression, and an adjustment means for adjusting said compression. 
     The strap may therefore include, in the context of the embodiments described in this specification, a flexible strap having two ends, hook and loop material placed at opposite ends of the strap, at least two non-adjacent inflatable balloons to be positioned over the radial and ulnar arteries, connectors and valves, and a removably attachable syringe or pump for inflating and deflating said balloons so as to provide adjustable compression over said arteries. The syringes or pumps referred to in this specification have a volume that can be filled with air or other gas, any portion of which, up to its capacity, may be injected into the balloons. Thus an operator may use the syringe or pump to inject varying amounts of air or gas into the balloons. Further, they are detachably connectable and re-usable so that they can further be used to withdraw or inject more air or gas during the course of a deployment onto a patient. Thus, these syringes or pumps have the characteristic of permitting an operator to make adjustments in the amount of air or gas present within the balloons. 
     It will be understood by those skilled in the art that, although the following drawings and Detailed Description disclose further aspects and advantages of the wristband and describes preferred embodiments, the present invention is not intended to be limited only to these preferred embodiments. It will be apparent that other changes in form and detail may be made therein without departing from the spirit and scope of the invention as defined in the appended claims. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a bottom view of an adjustable radial and ulnar compression wristband. 
         FIG. 2  is a side section view of the wristband with parts removed for clarity. 
         FIG. 3  is a bottom view of an alternative embodiment of the wristband. 
         FIG. 4  is a section view, with parts removed for clarity, of the wristband deployed on a wrist. 
         FIG. 5  is a top view, with parts removed for clarity, of the radial puncture site, with the wristband deployed on a wrist. 
         FIG. 6A  is a section end view, with parts removed for clarity, of movable inflatable cuff. 
         FIG. 6B  is a section end view, with parts removed for clarity, of an alternative embodiment of a movable inflatable cuff. 
         FIG. 7A  is a perspective end view of a movable inflatable cuff. 
         FIG. 7B  is a bottom view of a movable inflatable cuff. 
         FIG. 8  is a perspective end view, with parts removed for clarity, of a wristband with a movable inflatable cuff. 
         FIG. 9  is a perspective end view, with parts removed for clarity, of a wristband with two movable inflatable cuffs. 
     
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
     An adjustable radial and ulnar compression wristband  10 , for use in assisting with post-procedure radial artery hemostasis following catheterization or other cannulation, is shown in the Drawings and Detailed Description included herein as preferred embodiments of the present invention. Although parts are described as discrete components and features are described with specific structures, it will be understood by those skilled in the art that alternative means of construction to achieve the same purpose may be employed without deviating from the present invention. 
     The wristband  10  of the present invention generally includes at least: a flexible strap  11  having two ends; a securement means of fastening said strap circumferentially around a wrist or forearm preferably comprising “hook and loop” material, e.g. Velcro, the loop material  12  being placed at one end and the hook material  13  being placed at the opposite end of the strap  11 ; a compression means including at least two inflatable balloons, in a preferred embodiment comprising at least an ulnar balloon  30  and a radial balloon  40  separate from each other, to be positioned over the ulnar  103  and radial  101  arteries, and an inflation means and adjustment means for inflating and adjusting the interior volumes of said balloons  30  and  40 . Said inflation means and adjustment means generally comprises hollow tubes  31  and  41 , valve/connectors  32  and  42 , and a syringe or pump operated by a user that can be attached to the valve/connectors  32  and  42 . Each of the balloons  30  and  40  includes cavities  33  and  43  the injection of air or other gas into which causes inflation of the balloons  30  and  40 . Injection of such air or other gas is made by means of the syringe or pump that attaches to the valve/connectors  32  and  42 , such attachment being preferably removable, and the injection of air being adjustable by a user. Removable attachment is desirable so that patients are unable to make adjustments in the compression when the user removes the syringe or pump. The syringe or pump of the inflation means and adjustment means is further capable of adjustably withdrawing air or other gas from the cavities  33  and  43 , thus the volumes contained therein may be adjusted by a user. In an alternative embodiment described herein, the compression means also includes a balloon  70 , and may exclude other components as described in detail in this specification. Similarly, in such alternative embodiment, the inflation means and adjustment means also includes a cavity  73  of the balloon  70 , tube  71  and valve/connector  72 , in addition to the syringe or pump, and may exclude other components as described in detail in this specification. 
     In an alternative embodiment, the ulnar balloon  30  is absent from the strap  11 , replaced by a cuff balloon  70 , located on a slidably movable cuff  60  that slides along the strap  11  to enable greater flexibility in positioning compression over the ulnar artery  103 , the cuff balloon  70  having a construction and inflation and adjustment means similar to the ulnar  30  and radial  40  balloons. This is shown in  FIGS. 6A, 6B, 7A, 7B, 8 and 9 . The balloons  30 ,  40  and  70  are non-adjacent, specifically not adjacent to each other, i.e. they do not rest one upon the other in the vertical axis and do not necessarily touch each other, except as may be the case when a user positions a cuff balloon  70  side by side next to the balloons  30  or  40 . Further, it is within the scope of the invention that at least one of the balloons  30 ,  40 , or  70  may be provided for use pre-inflated, i.e. air or gas has been injected such that no further inflation by the user is needed, thus an inflation means and adjustment means is not present on such balloon  30 ,  40  or  70 . 
       FIGS. 1 and 2  shows the wristband  10  having a flexible strap  11 , to which is attached a piece of loop material  12  at one end on the bottom side and a piece of hook material  13  at the opposite end on the top side; this hook  13  and loop  12  material together located on the strap  11  comprise a securement means for fastening the wristband  10  around a wrist  100 . In the embodiment shown, the hook material  13  is positioned next to the radial balloon  40 . On the bottom side of the strap  11  are formed or attached two inflatable balloons, comprising at least an ulnar balloon  30  and radial balloon  40 ., which extend substantially across the entire width of the strap  11  ans are non-movable relative to the ends of strap  11 .Located between the balloons  30  and  40  and the strap  11  are, optionally, pieces of rigid backing, comprising the ulnar rigid backing  21  and radial rigid backing  22 . During inflation of the balloons  30  and  40  the rigid backing pieces  21  and  22  provide a relatively rigid surface against which the balloons  30  and  40  press against, causing them to preferentially compress portions of the skin surface of a wrist  100 . Attached to each of the balloons  30  and  40  are tubes, comprising at least the ulnar balloon tube  31  and radial balloon tube  41 . To each of these tubes  31  and  41  are attached valve/connectors, comprising at least the ulnar balloon valve/connector  32  and radial balloon valve/connector  42 .  FIG. 2  further shows within each of the balloons  30  and  40  cavities  33  and  43 . In this embodiment, the non-movcable balloons  30  and  40 , tubes  31  and  41 , connector/valves  32  and  42 , together with a syringe or pump to inflate the cavities  33  and  43  of the balloons  30  and  40 , comprise an inflation means and compression adjustment means for inflating the balloons  30  and  40 , and adjusting compression applied over the radial  101  and ulnar  103  arteries. 
     The rigid backings  21  and  22  are separate from each other and in a preferred embodiment may be entirely absent from the wristband  10 . Though the backings  21  and  22  would be absent, the space between the top surface of the balloons  30  and  40  and the underside of the strap  11  may optionally still be present to permit expansion of the balloons  30  and  40  such that the strap  11  provides the backing function. Additional layers of material may also be attached over the balloons  30  or  40  onto the strap  11  or thicker material may be used in order to provide a stronger, still-flexible backbone against which the balloons  30  or  40  may press against when inflated, to enable the same function as the rigid backings  21  and  22 . Alternatively, multiple layers of material may be attached, one layer onto another, for the entire length and width of the strap  11 , the layers being affixed to each other by means of adhesive, or by ultrasonic or radio-frequency welding or other means well-known to those skilled in the art, and additional layers being affixed along portions of the strap  11  to form features, for example, balloons  30  or  40 . Further, this multiple-layer construction, i.e. the points of attachment of the layers, by forming a single layer from multiple layers, serves to strengthen the material so as to reduce the extent to which the material of the strap  11  can be stretched when the strap  11  is placed under load while in shear, more particularly when such points of attachment extend along the longitudinal axis or sections thereof, or when they extend across the entire width of the strap  11 . Such points of attachment can further be used to form the balloons  30  and  40  from two or more layers of material. Such multiple-layer construction reduces stretching thus enabling the use of material for the strap  11  that is more compliant, thus more comfortable during deployment on a patient, compared to stiffer flexible material that, while stretching less in a single-layer construction, would be less comfortable particularly where the edges make contact with the patient&#39;s skin surface. 
     A line or other mark or marks may be placed in the center the radial balloon  40 , running proximally-distally, as a visually observable guide to assist the user in proper placement of the radial balloon  40 , i.e. generally over the radial artery  101 . Such mark or line may alternatively be placed in the same position, but on the strap  11 . Another line or other mark that perpendicularly crosses the first line or mark, the former positioned approximately ¼ to ½ of the proximal-distal length of the radial balloon  40  from its distal-most side may similarly be placed. The intersection of the two lines or marks further assists proper placement by indicating the general area of the radial balloon  40  that should be positioned over the puncture site  105 . 
       FIG. 3  shows an alternative embodiment of the wristband  10  in which the tubes  31  and  41  are connected to a stopcock  50  connected to a tube  51  that is in turn connected to a valve/connector  52 , to which is attached a syringe or pump used to inject air or other gas into the balloons  30  and  40 , i.e. the inflation means. The stopcock  50 , in this view, includes a switch stopcock lever  53 . In this alternative embodiment the inflation means therefore further includes a switching means comprising the stopcock  50  and its switch stopcock lever  53  to switch airflow, through the tubes from the pump or syringe, from one balloon to the other, or to both simultaneously. Alternatively, the switching means may comprise a fixed, non-changeable connector that directs flow of air or gas to both balloons  30  and  40  simultaneously. The tubes  31  and  41  are connected at their opposite ends to the balloons  30  and  40  respectively, which are located on the strap  11 . In this alternative embodiment, the balloons  30  and  40 , tubes  31 ,  41  and  51 , valve/connector  52 , together with a syringe or pump to inflate the balloons  30  and  40 , comprise a compression adjustment means, to adjust compression applied over the radial  101  and ulnar  103  arteries. Alternatively, the valve/connector  52  may be made integrally with the stopcock  50 , avoiding the need to have a tube  51 . The stopcock  50  together with switch stopcock lever  53 , i.e. a switching means, is a means of directing air or gas flow to and from one or the other or both of the balloons  30  and  40  and different embodiments of such a switching means may be substituted without departing from the scope of the invention. The hook  13  and loop  12  material comprising a securement means are also shown. 
       FIG. 4  shows the wristband  10  deployed onto a wrist  100 , the strap  11  having its two ends detachably fastened by means of the loop material  12  being attached to the hook material  13 . This section view shows the balloons  30  and  40 , non-movable attached to the strap  11 , inflated with air or other gas injected and maintained inside the cavities  33  and  43 , so as to apply compression onto portions of the surface of the wrist  100 , such compression further being preferentially applied to the radial artery  101  and ulnar artery  103  located below the skin surface, such compression not being applied, at least to the same degree, to the veins  104  in the wrist  100 . The radial balloon  40  is positioned over the access track  102 , puncture site  105  and arteriotomy  106 , through which the sheath passes into the radial artery  101 . In this preferred embodiment, the rigid backing pieces  21  and  22  are absent and the strap  11 , having thicker material or being formed as a multiple-layer construction, at least over the balloons  30  and  40 , undertakes the backing function of these backing pieces  21  and  22  to preferentially compress portions of the skin surface underlying the balloons  30  and  40 . 
       FIG. 5  shows, in top view with parts removed for clarity, the radial balloon  40  placed over the radial artery  101  and radial artery puncture site  105 , with proximal P and distal D directions indicated. When inflated, the balloon  40  will provide compression over the puncture site  105 , and the access track  102  that connects it to the arteriotomy  106  located proximally to the puncture site  105 . The blood flow  107  passes proximally to distally past the arteriotomy  106 , towards the hand. Size and placement of the radial balloon  40  provides sufficient surface area so that both the arteriotomy  106  and puncture site  105  are covered by the balloon  40 . Lines or other marks placed on the radial balloon  40  as previously described in this specification assist in positioning over the radial artery  101  and puncture site  105 . 
       FIG. 6A  shows, in section end view with parts removed for clarity, a movable inflatable cuff  60  that includes a balloon  70  that further includes a cavity  73 , and a lumen  74  through which the strap  11  passes. The cuff  60  may be slidably positioned along the strap  11  by a user. A space between the top surface of the balloon  70  and the underside of the cuff  60  is present to permit expansion of the balloon  70  such that the cuff  60  and strap  11  provides a backing function. 
       FIG. 6B  shows in section end view with parts removed for clarity an alternative embodiment of a movable inflatable cuff  60 A that includes a balloon  70  that further includes a cavity  73 , and a lumen  74  through which the strap  11  passes. 
       FIG. 7A  shows, in a perspective end view, a movable inflatable cuff  60  that includes a balloon  70  on its underside to which is connected a tube  71  and connector/valve  72 . A lumen  74  permits slidable movement of a strap  11  therethrough. The balloon  70 , tube  71 , connector/valve  72 , together with a syringe or pump to inflate the cavity  73  of the balloon  70 , comprise an inflation means and compression adjustment means to inflate the balloon  70  and adjust compression applied over a blood vessel that more particularly may be the ulnar  103  or radial  101  artery. The syringe or pump would be connected to the connector/valve  72  for inflating and adjusting volume of air in the cavity  73 . 
       FIG. 7B  shows, in a bottom view of a movable inflatable cuff  60 , a balloon  70  to which is connected a tube  71  and connector/valve  72 . 
       FIG. 8  shows, in a perspective end view with parts removed for clarity, an alternative embodiment of a wristband  10 A with movable inflatable cuff  60 , and strap  11 A to which is attached loop material  12 . The strap  11 A, which lacks the ulnar balloon  30 , passes through the lumen  74  of the cuff  60 , so that slidable movement of each relative to the other is enabled. The cuff  60  further includes a balloon  70 , shown on its underside, i.e. facing towards the skin surface. Attached to the balloon  70  are a tube  71  and connector/valve  72 . Not shown on the strap  11 A in this view is a radial balloon  40 , tube  41  and valve/connector  42 , and hook material  13 . The cuff  60  is included with strap  11 A, that has an attached non-movable radial balloon  40 , the cuff  60  replacing the absent ulnar balloon  30 , and is positioned by a user to compress the ulnar artery  103  during deployment onto a patient wrist  100 . 
       FIG. 9  shows, in a perspective end view with parts removed for clarity, another embodiment of a wristband  10 B with more than one inflatable cuff  60 , each having a lumen  74 , balloon  70 , tube  71  and valve/connector  72 , each of which can be slidably moved along the length of strap  11 B. Absent from strap  11 B are the ulnar  30  and radial  40  balloons. Also shown on strap  11 B is the loop material. Included but not shown on strap  11 B is the hook material  13 , thus  11 B includes a securement means. Other securement means besides hook  13  and loop  12  material may be used. 
     This embodiment thus includes two or more cuffs  60  with a strap  11 B that lacks both the ulnar  30  and radial  40  balloons, the cuffs  60  being positioned by a user over the ulnar  103  and radial  101  arteries for compression at time of deployment. More than two cuffs  60  may be included with the strap  11 ,  11 A or  11 B, for positioning at various locations around a wrist  100  including over the ulnar  103  and radial  101  arteries, or to provide cushioning or elevate the interior surfaces of the strap  11 A adjacent the balloon  70  off of the skin surfaces. 
     At time of deployment, the wristband  10  is placed around the wrist  100  with the balloons  30  and  40  facing towards the wrist and the radial balloon  40  generally over the radial artery  101  and puncture site  105 . The wristband  10  is wrapped around the wrist  100  and fastened snugly by actuating the securement means, in this embodiment by attaching the loop material  12  to the hook material  13 . The securement of the wristband  10  is thus maintained during the course of deployment, i.e. until hemostasis is achieved and the wristband  10  is removed. At the time of initial securement the balloons  30  and  40  are not inflated and a sheath is still present in the puncture site  105 . A syringe or other pump is first connected to the valve/connectors  32  and  42 , one at a time, and used to partially inflate the ulnar  30  and radial  40  balloons by injecting air or gas into the cavities  33  and  43 . Such syringe or pump remains attached to the radial valve/connector  42  prior to pulling the sheath, still inside the puncture site  102 . The sheath is then removed from the puncture site  102  and the syringe or pump is used to fully inflate the radial balloon  40  and then detached and attached to valve/connector  32  to further inflate the ulnar balloon  30 . In the embodiment shown in  FIG. 3 , the syringe or other pump is connected to the valve/connector  52  and the switching means, i.e. the switch stopcock lever  53  as shown, is configured so as to direct the flows of air or gas into the cavities  33  and  43  of the ulnar  30  and radial  40  balloons, or to both balloons  30  and  40  simultaneously. 
     The inflated balloons  30  and  40  expand, changing their shape, due to the expanding volume of air or gas in the cavities  33  and  43 . Because the wristband  10  is secured around the wrist  100 , as the balloon  40  expands in the vertical direction, i.e. perpendicular to the plane of the surface of the wrist  100 , it presses in the upward direction against the rigid backing  22  or in its absence against the strap  11 , thus its expansion being contained in that direction, i.e. against a relatively fixed circumference of the strap  11 . This causes the balloons&#39;  30  and  40  expansion to proceed preferentially in the downward direction onto the more compliant soft tissue of the wrist  100 . If the material or multiple-layer construction of the strap  11  provides sufficient strength to withstand excessive stretching or other deformation caused by the balloons&#39;  30  and  40  expansion, with or without a backbone, the rigid backing  22  is not needed and excluded from the wristband  10 ,  10 A or  10 B. The balloons  30  and  40  therefore exert sustained compressive force onto the surface of the wrist  100  and the soft tissue structures directly underlying it, specifically the ulnar  103  and radial  101  arteries. Such compression flattens or narrows the lumen of the ulnar  103  and radial  101  arteries, such narrowing depending on the degree of compression exerted by the inflated balloons  30  and  40 , and varying between completely closed or occluded, and open or patent. In none of the embodiments does one balloon apply compression or force onto another. 
     Though the shapes of the balloons  30 ,  40  and  60  are shown the drawings as rectangular, it is within the scope of the invention that they may also or instead have generally circular or oval shapes. Each balloon  30 ,  40 , and  60  has a footprint sufficient to cover the area overlying its target blood vessel, either the radial  101  or ulnar  103  artery, and the puncture site  102 , i.e. between 0.5 square inches and 3.0 square inches, more particularly between 1.5 and 2.5 square inches. The balloon over the radial artery  101  may be of different size than the balloon over the ulnar artery  103 . When uninflated, the balloons  30 ,  40  and  60  are generally flat; when inflated, for example, with 20 cc of air or gas, they distend, gaining between 0.25 to 1.5 inches in the vertical dimension due to the stretch inherent in a flexible, elastic material from which the balloons  30 ,  40  and  60  are made. Such stretch is responsible for approximately a 10% to 50% decrease of compressive force during the first five minutes of inflation; thicker material or multiple-layer construction in the strap  11  or  11 A results in a smaller decrease of compressive force. To accommodate wrists of varying size the length of the strap  11  is between 7.0 inches and 20.0 inches, more particularly between 8.0 and 14.0 inches, and the width between 0.75″ and 2.25″. 
     In an additional embodiment, a hemostatic agent, for example, generally composed of: i) chitosan or other polysaccharide such as a β-(1-4)-linked D-glucosamine (deacetylated unit) or N-acetyl-D-glucosamine, ii) thrombin, or iii) calcium alginate, or iv) compounds including minerals such as kaolin or potassium ferrate, is attached to the bottom of the balloons  30 ,  40 , or  60 , i.e. facing the skin surface, for the purpose of enhancing hemostasis of the puncture site  106  in conjunction with the compression provided by the inflated balloon  30 ,  40  or  60 . Well known to clinicians involved with vascular access, these hemostatic agents are often applied as “patches” in conjunction with manual compression or with external compression devices. More particularly, a hemostatic agent, in the form of a solid material, is removably attached to the bottom surface of the balloons  30 ,  40  or  60  to permit it to remain on the puncture site  105  after the wristband  10  or  11  or  11 A has been removed from the patient. Such removable attachment may take the form of an adhesive, or by placement on the bottom surface of a removable cuff encircling the balloon  30 ,  40  or  60  that can be held in place while the strap  10 ,  11  or  11 A is unfastened and slidably moved therethrough for removal from the patient. If an adhesive is used, it may cover the entire top surface of the hemostatic agent patch for adhering to the bottom surface of a balloon  30 ,  40  or  60 , or more preferably cover only a portion of such surface so that it i) may be more easily detached when the wristband  10  or  11  or  11 A is removed, and ii) does not interfere with expansion of the balloons  30 ,  40  or  60  during inflation, adjustment and deflation. Any shape of hemostatic agent may be used, but preferably at least a portion of it protrudes past the edges of the balloons  30 ,  40  or  60  to more permit operator to hold it in place thus more easily enabling detachment when the wristband  10 ,  11  or  11 A is removed from the patient. The size of the hemostatic agent can range from 5% of the bottom surface area of the uninflated balloons  30 ,  40  or  60  to 200% of such surface area. 
     Patent hemostasis, as described above in the background section, occurs when the lumen of the radial artery  101  is partially open thereby permitting a smaller than normal volume of blood flow  107  to pass therethrough while avoiding bleeding at the arteriotomy  106  and puncture site  105 . Injecting more gas or air into the cavity  43  increases volume, thus further compressing the vessel lumen and further limiting the blood flow  107 . Using the syringe or pump to withdraw gas or air from the cavity  43  decreases volume, thereby reducing compression of the lumen and increasing the volume of blood flow  107 . Similar adjustments to ulnar balloon  30  compression enables varying degrees of patency in the ulnar artery  103 . 
     The valve/connector  42  is closed when the syringe or pump is disconnected, thus generally preventing release of air or gas from inside the cavity  43 . Alternatively, the valve/connector  42  may permit a pre-programmed volume of air or gas inside the cavity  43  to slowly leak out over a period of time. Following disconnection from valve/connector  42 , the syringe or pump is then connected to the valve/connector  32  and is used to inflate the cavity  33  of the ulnar balloon  30  in a fashion similar to that already described for the radial balloon  40 . Once both balloons  30  and  40  are inflated the syringe or pump may be re-attached to the valve/connectors  32  and  42  and the volume of air or gas increased or decreased in the cavities  33  or  43  so as to enable patent blood flow  107  through the radial artery  101  and ulnar artery  103  without concomitant oozing or bleeding at the puncture site  105 . Patency can be readily determined using methods well known to clinicians, including direct manual palpation of the vessels, and use of doppler ultrasound, pulse oximeters or plethysmographs. The valve/connectors  32  and  42  may be check valves, swabable valves or other valves well known to those skilled in the art. 
     In the embodiment shown in  FIG. 3 , the syringe or other pump remains connected to the valve/connector  52  and the switching means is configured, following inflation of the balloon  40 , so as to direct the flow of air or gas into the cavity  33  of the ulnar balloon  30 . The ulnar balloon  30  is then inflated and the syringe or pump removed and re-inserted, if needed, as described above. Alternatively, the switching means may be set, either permanently or as desired by a user, so that inflation may be made simultaneously into both balloons  30  and  40 . The switching means thus permits either user-controlled direction of air flow into the balloons, or a fixed, non-changeable air flow into the balloons. In all of the embodiments described herein, the flow of air or gas proceeds from a single balloon or all balloons to the syringe or pump, or vice versa, and not from one balloon to any other. 
     In the embodiment shown in  FIG. 8 , after inflating the radial balloon  40 , the syringe or pump is disconnected from valve/connector  42  and then connected to the valve/connector  72  and used to inflate the cavity  73  of the cuff balloon  70  in a fashion similar to that already described for the ulnar balloon  30 , the cuff  60  replacing the ulnar balloon  30 . The cuff balloon  70  can be used to apply compression over the ulnar artery  103 , or depending on an operator&#39;s preference over the radial artery  101 , or over other portions of the wrist  100 . 
     Although the embodiments presented herein show the valve and connector as the same physical component, i.e. as in the valve/connectors  32 ,  42 ,  52 , and  72 , the valve function may be physically separated from the connector function. It is within the scope of the invention that the valve function, i.e. the means of permitting air or gas flow into and out of and maintaining air within the cavities  33 ,  43 , and  73  be a feature physically separate from the connector function, i.e. the means of removably attaching a syringe or pump. For example, the valve may be located at a point somewhere between the two ends of the tubes  31 ,  41 ,  51 , or  71 , or may be located at the point where the tubes  31 ,  41  or  71  joins the cavities  33 ,  43  or  73 . An example of valve operation may comprise manual operation, valve closing achieved by the air pressure in the cavity  33  or  43  pressing on a movable obstruction within the valve housing against a seat, and valve opening achieved by increasing air pressure caused by operation of the syringe or pump pressing in the opposite direction on said movable obstruction away from the seat to permit air or gas flow. This may be combined with a spring to help maintain the obstruction in place against the seat when air pressure is low or nil. Alternatively, mechanical means may be used for controlling valve operation, for example a spring may be used to achieve valve closure and either a physical feature on the syringe or pump or air pressure exerted by the syringe or pump is used to achieve valve opening by pressing on a mating feature connected to the obstruction. Preferred embodiments are expected to have the valve and connector functions contained within the same component, for example a spring-operated or pressure-operated check valve or swabable valve, all of which are well-known to those skilled in the art. 
     The wristband  10  is not limited to having only two balloons  30  and  40  or  40  and  70  in its construction. Other balloons functioning similarly may be included at other locations on the strap  11  for the purpose of providing cushioning for the patient around the wrist  100 , for example on the ulnar and radial sides of the wrist, and also to enable a standoff of the strap  11  from the surface of the wrist  100 , more particularly on its dorsal side. In addition to previously presented embodiments, it is within the scope of the invention that the ulnar  30  and radial  40  balloons are present on the strap  11 , and that a cuff balloon  70  also be included with the wristband  10  to provide an additional means for either compression or cushioning. 
     In the embodiments shown in the figures, the securement means is comprised of hook  13  and loop  12  material that, when joined together fastens the strap  11  around the wrist  100 . It is within the scope of the invention that other mechanisms may comprise alternate securement means for the wristband  10 , for example: a button and buttonholes, each being located at opposite ends of the strap  11 ; a belt slide or belt strip located at one end of the strap  11  through which the opposite end passes; a box frame buckle located at one end of the strap  11  through which the opposite end passes, an adjustable captive post sitting against the end of the strap  11  as it passes through the box frame to keep it in place by friction; a belt buckle located at one end of the strap having an open square frame and prong which passes through holes located at the other end of the strap  11 ; a plate style buckle located at one end of the strap  11  having a hook or pin that is inserted into holes at the other end of the strap  11 . For purposes of describing these alternative securement means, the strap  11  in the foregoing paragraph also includes strap  11 A and strap  11 B. 
     Flexible, elastic transparent synthetic material, for example a vinyl, polyvinylchloride, polyethylene or polyurethane or nylon or similar material, may be used in the construction of the strap  11  and balloons  30  and  40 . A more rigid transparent synthetic material, for example an acrylic or PVC or HDPE or PTFE or vinyl or nylon or polypropylene or polyethylene or similar material would be used in the construction of the optional rigid backings  21  and  22 , in the event these are included on the straps  11 ,  11 A or  11 B. Preferably the materials are biocompatible and sterilizable. Further, the straps  11 ,  11 A or  11 B may be formed as a multiple-layer construction. 
     All or part of the wristband  10  may also be composed of a material having anti-microbial properties sufficient to prevent growth of microbes or to kill microbes with which it comes into contact, for example on the skin of a patient on whom the wristband  10  is deployed. Alternatively, the exterior surfaces of the wristband  10  or some of its components may be treated with a process or material having anti-microbial properties. Examples of these processes and materials, which are well-known to those skilled in the art, can include: i) the deposition of silver or organic or inorganic particles onto the surfaces of the components of the apparatus by means of vapor deposition or liquid immersion; or ii) including silver or organic or inorganic particles mixed into the materials from which the components are formed. 
     A method of using the wristband  10  includes the following steps: 
     i) Placement and securement of the wristband  10  onto the wrist  100 . A user fits the wristband  10  around a wrist  100  of a patient and by attaching the loop  12  material to the hook  13  material fastens it snugly so that the uninflated radial balloon  40  is positioned over the radial artery  101  and puncture site  105 , and the uninflated ulnar balloon  30  is positioned generally over the ulnar artery  103 . Marks or lines placed on the radial balloon  40 , strap  11  or backing  22  may assist in this positioning. When using an alternate embodiment of the wristband  10 A as in  FIG. 8 , the user, prior to attaching the loop  12  to the hook  13  material, positions the cuff balloon  70  over the ulnar artery  103  by sliding the cuff  60  to the appropriate position; the user then fastens the loop  12  to the hook  13  material. When using an alternate embodiment of the wristband  10 B as in  FIG. 9 , the user, prior to attaching the loop  12  to the hook  13  material, positions the cuff balloons  70  over the ulnar  103  and radial  101  arteries by sliding the cuffs  60  to the appropriate positions, i.e. over the target blood vessels; the user then fastens the loop  12  to the hook  13  material. 
     ii) Initial inflation of the balloons  30  and  40 . A user attaches a syringe or pump to the valve/connector  32  and injects air into the cavity  33  to increase compression onto the skin surface of the wrist  100 , thereby partially compressing the ulnar artery  103  such that the blood flow continues to pass therethrough but at a reduced flow rate. The user then attaches the syringe or pump to the valve/connector  42  and injects air into the cavity  43  via the tube  41  to inflate the balloon  40  to increase compression onto the skin surface of the wrist  100 , thereby partially compressing the radial artery  101  such that the blood flow continues to pass therethrough but at a reduced flow rate. In the alternative embodiment of  FIG. 3 , the user attaches the syringe or pump to the valve/connector  52  instead of valve/connectors  32  and  42  and actuating the switching means to inject air into balloons  30  and  40 . In the embodiment shown in  FIG. 8 , the user attaches the syringe to valve/connector  72  instead of valve/connector  32 , then proceeds with inflation as described in the foregoing for balloon  30 . In the embodiment shown in  FIG. 9 , the user attaches the syringe to valve/connectors  72  instead of valve/connector  32  and, then proceeds with inflation as described in the foregoing for balloons  30  and  40 . 
     iii) Removing the sheath or cannula from the puncture site  105  and fully inflating the balloon  40 . While preparing to further inflate the balloon  40  with the syringe or pump, the sheath or cannula is pulled from the puncture site  105 . On complete removal of the sheath or cannula, the balloon  40  is fully inflated by injecting air with the syringe or pump into the cavity  43  through the valve/connector  42 , such that there is no bleeding from the puncture site  105 . In the embodiment shown in  FIG. 9 , the user attaches the syringe to valve/connector  72 , to inflate cuff balloon  70 , instead of valve/connector  42  and then proceeds with inflation as described in the foregoing for balloon  40 . 
     iv) Adjusting inflation of the ulnar balloon  30 . The user disconnects the syringe or pump from the valve/connector  42  and connects it to the valve/connector  32 . In the alternative embodiment of  FIG. 3 , the user instead configures the switching means, e.g. the switch stopcock lever  53 , to re-direct air into the ulnar balloon  30  and not the radial balloon  40 . Air or gas is then injected into or withdrawn from the balloon  30  to adjust compression onto the skin surface of the wrist  100 , to compress the ulnar artery  103  to slow or completely occlude blood flow therethrough. When using an alternate embodiment shown in  FIG. 8 or 9 , the user, instead of connecting the syringe to the valve/connector  32 , connects it to the valve/connector  72  of the balloon  70  positioned over the ulnar artery  103  and inflates said balloon  70  to compress ulnar artery  103  as described in the foregoing for balloon  30 . 
     v) Achieving patent hemostasis. The distal pulses of the radial  101  and ulnar  103  arteries are assessed using methods well-known to clinicians and include the Allen Test, Reverse Allen Test or Barbeau Test using palpation, pulse oximeters or plethysmographs, or ultrasound to detect pulses distal to the points of compression. In the event a distal pulse is not detected for the radial artery  101 , the syringe or pump is used to gradually remove air or gas from the cavity  43  of the radial balloon  40  so as to reduce compression until a distal radial artery  101  pulse is detected without concomitant bleeding from the puncture site  105 . Instead of or in addition to injecting into or withdrawing air or gas from the radial balloon  40 , the syringe or pump may be used to gradually inject into or withdraw air from the ulnar balloon  30  or the cuff balloon  70  that is placed over the ulnar artery  103  until the distal radial artery  101  pulse is detected without concomitant bleeding from the puncture site  105 . While the wristband  10  is deployed and applying compression, it may be gradually adjusted periodically by using the syringe or pump to inject into or withdraw air from the ulnar  30 , radial  40  or cuff  70  balloons. In the embodiment shown in  FIG. 9 , the user attaches the syringe to valve/connector  72  of the cuff balloon  70  placed over the radial artery  101  instead of the valve/connector  42 , and then proceeds with adjusting the inflation of said cuff balloon  70  as described in the foregoing for balloon  40 . 
     vi) Removing the wristband  10  from the wrist  100 . When hemostasis is achieved at the puncture site  105  and arteriotomy  102 , for example after one or two hours of compression with patency present in both the ulnar  103  and radial  101  arteries, the syringe or pump is used to slowly withdraw air or gas from the balloons  30 ,  40  and  70  until the cavities  33 ,  43  and  73  are empty. The user may then separate the hook  13  material from the loop  12  material and remove the wristband  10  from the patient&#39;s wrist  100 . 
     The present invention thus achieves its objectives through the embodiments and methods described herein. It will be understood that the present invention is not limited to the method or detail of construction, fabrication, material, application or use described and illustrated herein. Indeed, any suitable variation of fabrication, use, or application is contemplated as an alternative embodiment, and thus is within the spirit and scope of the invention. Accordingly, while the present invention has been shown and described with reference to the foregoing embodiments of the invented apparatus and method of use, it will be apparent to those skilled in the art that other changes in form and detail may be made therein without departing from the spirit and scope of the invention as defined in the claims. 
     It is further intended that any other embodiments of the present invention that result from any changes in application or method of use or operation, configuration, method of manufacture, shape, size, or material, which are not specified within the detailed written description or illustrations contained herein yet would be understood by one skilled in the art, are within the scope of the present invention.