Abstract:
A combination radial arm band and hemostatic material preferably including potassium ferrate and a cation ion exchange resin in powder or granular form (WOUNDSEAL) or formed into a solid tablet (STATSEAL) and having improved topical effectiveness in the arresting of blood flow from a puncture wound into the radial artery made during transradial diagnostic or interventional catheterization procedures. The combination reduces time and pressure needed to achieve hemostasis and decreases arterial damage as compared to use of a radial arm band alone. In one aspect of this disclosure, careful limitation of applied force and time of applied force against the STATSEAL tablet reduces likelihood of harm to the radial artery while minimizing time to achieve hemostasis.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    Not applicable 
       STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT 
       [0002]    Not applicable 
       INCORPORATION-BY-REFERENCE OF MATERIAL SUBMITTED ON A COMPACT DISC 
       [0003]    Not applicable 
       BACKGROUND OF THE INVENTION 
     Field of the Invention 
       [0004]    This disclosure relates generally to hemostatic products, and particularly to the novel combination of a hemostatic device or material and a radial arterial compression band which, when applied together to a bleeding puncture wound following transradial diagnostic or interventional catheterization procedures, substantially reduce time and/or pressure to achieve hemostasis. An improved syringe for achieving optimal pressure against a bleeding artery puncture to more effectively achieve hemostasis may also be provided. 
       DESCRIPTION OF RELATED ART 
       [0005]    Hemostasis powders are well known. Thompson et al, U.S. Pat. No. 4,545,974 &amp; 4,551,326, disclose processes for the manufacture of potassium ferrate and similar high oxidation state oxyiron compounds. Patterson et al U.S. Pat. No. 6,187,347 and Patterson et al. U.S. Pat. No. 6,521,265, disclose the mixing of potassium ferrate and anhydrous strongly acidic cation exchange resins for the cessation of bleeding. These patents are incorporated by reference herein in their entirety. This powderous or granular hemostatic mixture has been formed into solid tablet or wafer devices as disclosed in Hen et al., U.S. Pat. Nos. 8,961,479 and 9,039,667, both incorporated herein by reference. 
         [0006]    Transradial catheterization is an endovascular procedure or catheterization procedure performed to diagnose and treat arterial disease (e.g., coronary artery disease, peripheral artery disease, etc.). Endovascular procedure can be performed achieving access into body&#39;s arterial system from either femoral artery (in groin), brachial artery (in elbow) or radial artery in the wrist. The transfemoral (through groin) approach to perform cardiac catheterization has typically been more prevalent in invasive cardiology. But, radial access has gained in popularity due to technical advances with catheters and lower complication rates than transfemoral access. 
         [0007]    In past few years, transradial access for coronary intervention has become increasingly popular. The most advantageous aspect is lower access-site bleeding complications even with aggressive use of anticoagulation and antiplatelet therapies. During the angioplasty and stent procedures, patients are given therapeutic (high) doses of anticoagulation (blood thinners) and platelet inhibiting medications. 
         [0008]    With transfemoral access, the rate of bleeding complications is 3%-6%. Occasionally patients can develop retroperitoneal bleeding (bleeding into the pelvic cavity), and up to 1% of patients require blood transfusion to treat the bleeding complication after transfemoral catheterizations. Patients may also develop painful hematoma, A-V fistula or pseudoaneurysms. In modern interventional cardiology, the procedural success rates are high and ischemic complications are relatively rare. However the bleeding complications associated with transfemoral catheterization have not been significantly reduced even after trying new pharmacological strategies. There are strong evidence suggesting that post PCI bleeding is associated with an adverse prognosis. Post-procedural blood transfusion is also associated with poor prognosis. Bleeding complication, pseudoaneurysm, hematoma formation are less than 2% with transradial catheterization. Possibility of blood transfusion requirement is extremely rare after transradial catheterization. 
         [0009]    The other reason for the increased use of radial access is the technological advances in the sheath and catheter design and improved physician experience with this approach. With improvement in the physician&#39;s experience, radial artery access is now being used with equal efficacy to treat almost every complex coronary artery disease, including acute myocardial infarction, chronic total occlusion, bifurcation coronary artery disease and rotablation. Radial access has also been used successfully to treat peripheral artery disease including bilateral iliac artery stenosis, renal artery stenosis and for carotid interventions. 
         [0010]    Due to rapid ambulation post procedure, the radial interventions became particularly attractive for patients with back pain, chronic obstructive lung disease, prostatic hypertrophy and elderly patients. As after catheterization through femoral approach, patient is generally required to lay flat with immobilization of the leg for 4-6 hours. Early ambulation and early discharge after transradial catheterization improves quality of life and reduces morbidity. Both patients and hospital staff typically strongly prefer the transradial approach as opposed to femoral access. 
         [0011]    Although transradial procedures often have fewer complications than femoral procedures, they have some shortcomings. The procedure is technically more difficult and has a relatively long learning curve, which includes the potential for unsuccessful completion of procedure during the learning curve. In clinical trials before crossing the learning curve, there is up to 5% failure in completing the catheterization successfully from radial approach. Technical difficulties are because of loops and tortuosity of the radial and the subclavian artery, anatomical variations in radial artery, and radial spasm. 
         [0012]    Major complication associated with a transradial interventions include early and late radial artery occlusion. Most of the radial artery occlusions are asymptomatic. Post PCI radial artery occlusion can be reduced by using smaller diameter catheters and anticoagulation. Also by avoiding prolonged compression of the radial artery and applying just enough pressure to achieve hemostasis reduces this complication of asymptomatic radial occlusion significantly. Implying this approaches the radial artery occlusion rate has come down to 1.1-1.8%. 
         [0013]    All radial bands on the market today operate by one of the following methods to apply pressure to the radial artery: 
         [0014]    1) A balloon held in place with a VELCRO strap and filled with a “volume” of air/water. 
         [0015]    2) A strap that is pulled tight with a solid or foam pressure attachment over the artery
       a. VELCRO material   b. Zip Tie   c. Elastic band       
 
         [0019]    3) A screw mechanism to apply pressure 
         [0020]    The problem with all of these devices is they are relying on a person to apply the band to every patient&#39;s arm exactly the same way to achieve a consistent result. The bands are put around the wrist and secured with VELCRO material. Next, the band is inflated to a volume of air to apply pressure to the bleeding site. A medical professional can accurately apply a correct volume of air. However, variation in applying the band will impact the pressure created as the balloon is inflated. These variations are: 
         [0021]    1) Size of patient&#39;s wrist; 
         [0022]    2) How tightly the band is secured to the wrist; 
         [0023]    3) Different personnel putting the bands on patients. 
         [0024]    Not only will an individual medical professional vary slightly from patient to patient, but different personnel will be applying the bands. 
         [0025]    Testing has shown that an 80% difference in force applied to the wrist by the same medical professional, using the same patient&#39;s wrist, applying the band twice within 45 minutes. These medical professionals had less than 3 mm difference in the tightness of the band (measured by overhang of the strap). Less than 3 mm of band tightness resulted in nearly a doubling of force applied to close the artery. 
         [0026]    The foregoing examples of the related art and limitations related therewith are intended to be illustrative and not exclusive. Other limitations of the related art will become apparent to those skilled in the art upon a reading of the specification and a study of the drawings. 
       BRIEF SUMMARY OF THE INVENTION 
       [0027]    This disclosure is directed to the combination, in one aspect, of a novel hemostatic device or material marketed by Biolife, L.L.C. under the trademark STATSEAL and a radial arm band. The device as a solid hemostatic tablet is applied to a transdermal puncture wound followed by applying pressure against the puncture wound by applying the radial arm band around the arm and against the hemostatic tablet for a time sufficient to clot and arrest substantial further blood flow from the puncture wound in the radial artery. 
         [0028]    In another embodiment, the hemostatic device is in powder or granular form marketed by Biolife, L.L.C. under the trademark WOUNDSEAL with or without magnetite, the pressure pad having a magnet for ease of picking up and holding a quantity of WOUNDSEAL with magnetite. 
         [0029]    In another embodiment, the hemostatic device (STATSEAL) is in solid tablet form and the system which applies pressure against the tablet includes regulation of applied pressure so as to carefully limit the force applied against the tablet, puncture, and radial artery to minimize time, pressure, and potential harm to the artery. 
         [0030]    All radial arm bands have a pressure pad or surface which applies a variable pressure against the cannula puncture into the radial artery which occurs during transradial diagnostic or interventional catheterization procedures. The combination of the hemostatic device and a radial artery band of this disclosure produces a synergistic shortening of time and applied pressure required to effect hemostasis. Where the pressure interface with the puncture is an inflatable member such as a balloon, a novel syringe arrangement to more accurately regulate applied pressure against the puncture may also be provided. 
         [0031]    The following embodiments and aspects thereof are described and illustrated in conjunction with systems, tools and methods which are meant to be exemplary and illustrative and not limiting in scope. In various embodiments one or more of the above-described problems have been reduced or eliminated while other embodiments are directed to other improvements. In addition to the exemplary aspects and embodiments described above, further aspects and embodiments will become apparent by reference to the drawings and by study of the following descriptions. 
     
    
     
       BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S) 
         [0032]      FIGS. 1A and 1B  are perspective and top plan views, respectively, of a round tablet embodiment of the hemostatic device of the combination. 
           [0033]      FIGS. 1C and 1D  are perspective and top plan views, respectively, of a rectangular embodiment of the hemostatic device. 
           [0034]      FIG. 2  is a perspective view of a radial arm band  14  in place on an arm A of a patient showing the position of the radial arm band  14  relative to the radial and ulnar arteries R and U of the arm A. 
           [0035]      FIG. 3  is a schematic cross-sectional view of the wrist anatomy of  FIG. 2 . 
           [0036]      FIG. 4  is a side view of an adjustable radial arm band  16  for use in conjunction with the hemostatic tablet  10 . 
           [0037]      FIG. 5  is a perspective view of another adjustable radial arm band  22  for use in conjunction with the hemostatic tablet  12 . 
           [0038]      FIG. 6  is a perspective view of another adjustable radial arm band  34  for use in conjunction with the hemostatic tablet  10 . 
           [0039]      FIG. 7A  is a perspective view of another adjustable radial arm compression band  50  for use in combination with the hemostatic device  10 . 
           [0040]      FIG. 7B  is a section view of the plunger  62  of  FIG. 7A . 
           [0041]      FIG. 8  is a section view showing another radial arm band  70  having an inflatable balloon for applying pressure against the radial artery R with the hemostatic device  10  positioned against the puncture. 
           [0042]      FIG. 9  is a perspective view of a femoral compression device  90  for use in combination with the hemostatic tablet  10 . 
           [0043]      FIG. 10  is a perspective view of another adjustable radial arm band  110  for use in combination with hemostatic tablet  10 . 
           [0044]      FIGS. 11A and 11B  are side elevation and perspective views, respectively, of another adjustable radial arm band  120  in combination with hemostatic tablet  10 . 
           [0045]      FIGS. 12A to 12C  depict use of WOUNDSEAL hemostatic powder with and without magnetite in combination with a radial arm band  140 . 
           [0046]      FIGS. 13 to 17  show embodiments of the invention which utilize a STATSEAL hemostatic tablet  10  and a radial arm band system  170 ,  190 ,  210 ,  240 , or  270  in conjunction with pressure controlling devices which prevent over-pressurization of the hemostatic tablet  10  against the puncture and radial artery R. 
           [0047]      FIGS. 18A, 18B, 19A and 19B  show other embodiments of syringe assemblies  290  and  320  which utilize a STATSEAL hemostatic tablet  10  in conjunction with a controlled pressure application system incorporating an inflatable balloon for preventing over-pressurization of the STATSEAL tablet against the puncture and radial artery R. 
       
    
    
       [0048]    Exemplary embodiments are illustrated in reference figures of the drawings. It is intended that the embodiments and figures disclosed herein are to be considered to be illustrative rather than limiting. 
       DETAILED DESCRIPTION OF THE INVENTION 
     Nomenclature 
       [0000]    
       
           10 . round hemostatic tablet 
           12 . square hemostatic tablet 
           13 . band member 
           14 . radial arm clamp 
           15 . pad member 
           16 . radial artery compressor 
           18 . adhesive layer 
           19 . support pad 
           20 . compression pad 
           22 . radial artery compression device 
           24 . radial arm band 
           26 . plastic support plate 
           28 . color marker 
           30 . turn cap 
           32 . compression pad 
           34 . radial artery compression device 
           36 . band 
           38 . transparent support plate 
           40 . screw nut 
           42 . air cushion 
           44 . radial artery compression device 
           50 . radial artery compression device 
           52 . footplate 
           54 . footplate 
           58 . rack 
           60 . rack 
           62 . plunger 
           64 . housing 
           66 . footplate 
           70 . radial arm compression device 
           72 . band 
           74 . curved outer plate 
           76 . balloon 
           78 . cavity 
           80 . connector 
           90 . femoral compression device 
           92 . belt 
           94 . base plate 
           96 . belt engaging end 
           98 . belt engaging end 
           100 . support cup 
           102 . Inflatable pressure element 
           104 . pump 
           110 . radial artery compression device 
           112 . strap 
           114 . compression pad 
           116 . adjustment knob 
           118 . band end 
           120 . hemostasis band 
           122 . body component 
           124 . body component 
           126 . hinge 
           128 . pad 
           130 . sensor apparatus 
           132 . balloon 
           134 . fastener component 
           136 . fastener component 
           140 . radial artery hemostatic system 
           142 . support plate 
           144 . plunger tube 
           146 . WOUNDSEAL hemostatic powder 
           150 . WOUNDSEAL hemostatic powder and magnetite 
           152 . plunger 
           154 . pressure pad 
           156 . magnet 
           158 . container 
           160 . radial arm band 
           170 . radial artery hemostatic system 
           172 . radial band assembly 
           174 . radial band 
           176 . support plate 
           178 . plunger housing 
           180 . plunger 
           182 . pressure pad 
           183 . pressure control device 
           184 . relief valve 
           186 . pressure relief port 
           188 . check valve 
           189 . syringe 
           190 . radial artery hemostatic system 
           192 . radial arm band assembly 
           194 . support plate 
           196 . plunger housing 
           198 . plunger 
           200 . calibrated spring 
           202 . pre-activation detent 
           204 . plunger travel limit 
           206 . pressure pad 
           210 . radial artery hemostatic system 
           224 . pressure release 
           226 . syringe 
           228 . pressure regulator 
           230 . tip 
           232 . pressurization port 
           234 . pressurization relief port 
           240 . radial artery hemostatic system 
           242 . radial band assembly 
           244 . radial band 
           246 . support plate 
           248 . balloon 
           250 . pressure regulator assembly 
           252 . syringe 
           254 . adjustable pressure regulator 
           256 . syringe tip 
           258 . pressurization port 
           260 . pressure relief port 
           262 . check valve 
           264 . balloon inlet 
           266 . adjustment knob 
           270 . radial artery hemostatic system 
           272 . pressure regulator assembly 
           274 . syringe 
           276 . adjustable pressure regulator 
           278 . adjustment knob 
           280 . pressure relief port 
           282 . syringe tip 
           284 . pressurization port 
           286 . check valve 
           290 . syringe assembly 
           292 . syringe body 
           294 . syringe pressure tube 
           296 . sight tube 
           298 . movable pressure indicator 
           300 . air transfer passage 
           302 . syringe nozzle 
           304 . air discharge port 
           306 . collar 
           308 . sight chamber 
           310 . syringe chamber 
           312 . plunger 
           314 . plunger seal 
           316 . syringe discharge pressure portion 
           320 . syringe assembly 
           322 . plunger assembly 
           324 . plunger 
           326 . sight pressure tube 
           328 . movable pressure Indicator 
           330 . plunger seal 
           332 . air pressure port 
           334 . sight chamber 
           336 . sight pressure chamber 
           340 . syringe tube 
           342 . syringe chamber 
           346 . syringe nozzle 
       
     
         [0193]    U.S. application Ser. No. 09/500,902, filed Feb. 9, 2000, now U.S. Pat. No. 6,187,347, issued Feb. 13, 2001, for a hemostatic composition (WOUNDSEAL) for Arresting the Row of Blood and Method is incorporated herein by reference in its entirety. 
         [0194]    U.S. application Ser. No. 13/760,319, filed Feb. 6, 2013, now U.S. Pat. No. 8,979,726 for Hemostatic Composition (WOUNDSEAL) with Magnetite is incorporated herein by reference in its entirety. 
         [0195]    U.S. application Ser. No. 13/847,057, filed Mar. 19, 2013, now U.S. Pat. No. 8,961,479 for Hemostatic Device (STATSEAL) and Method (incorporated herein by reference) are shown in  FIGS. 1A through 1D . 
         [0196]    Referring to  FIG. 2 , a prior art radial arm clamp  14  disclosed in U.S. Pat. No. 4,760,846, includes a band member  13  and a pad member  15 . The band member  13  includes a strap approximately 14″ long having an array of parallel transverse ridges formed on its underside surface. A buckle is formed at one end of the strap and includes a slot through which the strap portion can pass. The buckle also includes a tongue having teeth (not shown) which engage the ridges of the strap to permit the clamp to be held in place around the arm A. The tongue is spring biased to bring the teeth into engagement with the ridges. The tongue is moveable, however, for permitting the clinician to disengage the teeth from engagement with the ridges for removal of the clamp from the patients arm. 
         [0197]    The radial arm clamp  14  provides pressure over a transdermal puncture site in an artery, such as the radial artery, to stanch the flow of blood from the artery and to induce hemostasis without otherwise overly constricting the radial artery, while permitting the clinician to perform other tasks as hemostasis is achieved.  FIG. 3  shows schematically in cross section the forearm ulnar bone, radius bone, arteries, and nerves of the left forearm, as disclosed in U.S. Pat. No. 6,663,653. 
         [0198]    With reference to  FIG. 4 , an adjustable radial artery compressor  16  includes a support arm and a compression arm pivotally connected together at their proximal ends to form an adjustable C-shaped clamp. The support arm and the compression arm are pivotally connected in a hinge joint in such a way that the proximal end of the support arm extends behind the compression arm. At the distal end, i.e., the end remote from the hinge joint, the inside of the support arm is provided with a support pad  19 , and an opposing compression pad  20  is provided on the distal end of the compression arm. A clamping screw is threaded through the proximal end of the support arm in such a way that the front end of the clamping screw is in contact with the compression arm. By screwing the clamping screw inwards or outwards, the distance between the support pad and the compression pad  20  can be adjusted, thereby serving as a pressure activator by controlling the compression pressure in the direction of the arrow applied on the radial artery. The tablet  10 , attached to the compression pad  20  by an adhesion layer  18 , contacts against the puncture in the radial artery under controlled pressure to accelerate hemostasis. (Note that, for all radial artery band embodiments, tablets  10  and  12  are substantially interchangeable.) 
         [0199]      FIG. 5  illustrates the SAFERLIFE radial compression device  22  by Saferlife Products, Ltd. which stops includes a pressure actuator which bleeding by simply adjusting the band  24  or turn cap  30 . The color marker  28  helps medical staff to distinguish the pressure marking bleeding point comfort. It is latex free, transparent, soft and not adhesive to the skin so that medical staff can operate precisely, effectively controlling bleeding after radial artery puncture. The hemostatic tablet  12  is attached against the compression pad  32  to make compressive contact with the puncture to reduce applied pressure against the puncture and to accelerate hemostasis. 
         [0200]      FIG. 6  illustrates another hemostasis radial artery compression device  34  by Medplus Inc. which includes a pressure actuator which assists hemostasis of the radial artery after a transradial procedure. The transparent design of support plate  38  of the device  34  enhances the precise observation of blood compression in the artery puncturing spot. Pressure can be adjusted by tightening or loosening the band  36  or screw nut  40  to enhance postoperative artery/puncture compression. A color marker assists medical staff to distinguish the pressure and makes bleeding stoppage more comfortable. The soft air cushion  42  is made of special material. There is no need to fix the patient&#39;s arm which greatly reduces a patient&#39;s pain. The device  34  ensures accuracy of pressure at the puncture spot while not overly pressing the ulnar artery making pressure to stop bleeding is more accurate. The device  34  is used to achieve hemostasis of the radial artery after an intervention or angiography operation or hemodialysis operation or invasive monitor for blood pressure. Tablet  10 , attached to the air cushion, presses lightly against the puncture to greatly reduce time and pressure needed to achieve hemostasis. 
         [0201]      FIGS. 7A and 7B  illustrate another radial artery compression device  50  disclosed in U.S. Pat. No. 8,777,982. The hemostasis device  50  comprises footplates  52  and  54 , a housing  64  centrally positioned between footplates  52  and  54 , and a plunger  62  acting as a pressure actuator. The engagement of the plunger  62  within the housing  64  provides for one-directional movement of the plunger  62  in the direction of the arrow by use of a ratcheting mechanism. The plunger  62  may be forced downwardly toward the wound site by applying pressure in the direction of the arrow against pad  56 , but is restrained from movement upwardly in the cylinder by the combination and position of racks  58  and  60  and the corresponding pawls or racks in the cylinder. The hemostatic tablet  10  is attached to the footplate  66  to make contact against the puncture. 
         [0202]      FIG. 8  is a cross section view showing a radial arm compression device  70  disclosed in U.S. Pat. No. 7,498,477 attached around an arm. The balloon  76  comes into contact with the curved outer plate  74  through the band  72 . Moreover, the balloon  76  is connected to the band  72  only on one side through a connector  80 , thus giving the balloon  76  a somewhat tilted orientation which enables the compression pressure F applied to the puncture site to act in an oblique direction, that is, in a direction facing the center of the wrist. The hemostatic tablet  10  is attached or held within a mating cavity  78  against the balloon  76  over the puncture and the radial artery to more rapidly achieve hemostasis. 
         [0203]      FIG. 9  shows a femoral compression device  90  disclosed in U.S. Pat. No. 6,827,727 comprising a compressor and an inflatable pressure element  102  which acts as a pressure actuator. The compressor comprises a base plate  94 , a belt  92  which is adapted to be fixed around a patient&#39;s limb, and a pump  104  connected to the inflatable pressure element  102 . The base plate  94  has a top portion and a bottom portion and is adapted to be fixed to the belt  92  at belt engaging ends  96  and  98 . The inflatable pressure element  102  is provided at the bottom portion of the base plate  94  and is held within a support cup  100 . The hemostatic tablet  10  is positioned between the inflatable pressure element or against the puncture. 
         [0204]    Now referring to  FIG. 10 , a radial artery hemostatic compression device  110  is specifically designed for economical, hands-free radial artery hemostasis for post-catheterization patients. The device  110  includes a strap  112 , an adjustment knob  116  and a movable serrated band end  118  which interacts with the adjustment knob  116  to move the compression pad  114  as a pressure actuator for conveniently applying external compression to a patient&#39;s wrist. Compression pad  114  increases comfort for patients during deployment. The device  110  provides excellent access site visibility and is easily deployed by a single operator and focused compression, enabling patient ulnar flow and venous return. However, the addition of the hemostatic tablet  10  between the compression pad  114  and the puncture substantially reduces both time and pressure to achieve hemostasis. 
         [0205]    Now referring to  FIGS. 11A and 11B , a sensor apparatus  130  is embodied in an integrated hemostasis band  120  disclosed in U.S. Published Application No. 2014/0012120. Two fastener components  134  and  136  comprised of interlocking clasps can open and close the apparatus  120 . The body components are semi-rigid/semi-flexible bands that are substantially transparent and pivotally connected together by hinge  126 . A balloon  132  is the pressure component and serves as a sensor enhancement component. Two gaps on the balloon allow the balloon to slide along the body component  124  in the direction of the arrows. An inlet provides for air to be added or released from the balloon  132 . The hemostatic tablet  10  is attached to the skin-facing surface of a compressible pad  128 . 
         [0206]    Referring now to  FIGS. 12A to 12C , novel embodiments are there shown which utilize powderous WOUNDSEAL in lieu of solid STATSEAL tablets. In  FIG. 12A , WOUNDSEAL plus magnetite  150  is attracted from a container  158  to the pressure pad  154  of a plunger  152  or pressure actuator having a magnet  156  held therein. The plunger  152 , carrying a quantity of WOUNDSEAL plus magnetite  158  is inserted into a plunger tube  144  of a radial arm band  160  positioned over the puncture into the radial artery R as shown in  FIGS. 12B and 12C . Downward pressure on the plunger  152  will collapse the puncture and radial artery which, in cooperation with the hemostatic WOUNDSEAL, will more quickly arrest blood flow. As seen in  FIG. 12C , powderous WOUNDSEAL alone may alternately be poured into the plunger tube  144  over the puncture before the plunger  152  is inserted. 
         [0207]    Referring to  FIG. 13 , to reduce excessive variation of pressure applied to close the artery and arrest blood flow from the puncture wound, it is desirable to carefully regulate that pressure by incorporating a pressure control device  183  into a radial artery hemostatic system  170 . A relief valve  184  is provided to limit the pressure delivered from a syringe  189  into a plunger housing  178  of a radial band assembly  172 . Thus, a controlled, predetermined pressure is delivered out of a check valve  188 . Instead of putting a predetermined volume of air into the plunger housing  178 , it is pressurized to a preset (or adjustable) limited air pressure. The pressure is pre-determined by the minimum force needed against the plunger  180  as the pressure actuator to achieve hemostasis at the artery in an acceptable minimum amount of time. A VELCRO strap of the radial arm band  174  of this assembly  172  holds the radial arm band  174  around the patient&#39;s wrist. The check valve  188  prevents the plunger  180  from retracting. Variation in how tightly the assembly  172  is strapped around the wrist is compensated for by controlling the travel of the plunger  180  and the force applied by the pressure pad  182  against the STATSEAL tablet  10  as automatically determined by the pressure relief valve  184 . 
         [0208]    As seen in  FIG. 14 , the plunger  198  of this radial artery hemostatic system  190  is driven mechanically by a calibrated compression spring  200  of a predetermined spring length and spring rate serving as the pressure actuator to apply pressure to the puncture wound. The spring  200  may be designed to compress upon application of the VELCRO strap or designed to be applied pre-compressed; a pre-activation detent  202  is released after attachment of the radial arm band assembly  192  around the arm. The spring can vary in length and spring rate for different applications. When tested with a thin flexiforce strip to measure surface pressure applied against the STATSEAL tablet  10 , the pressure pad  202  provided very consistent applied pressure results over the puncture wound and STATSEAL tablet  10  even with variations in the initial tightness of the band assembly  192 . 
         [0209]    Referring to  FIG. 15 , a consolidated syringe activated radial artery hemostatic system  210 , which is a combination of a pressure regulator  228  or pressure actuator and a radial arm band assembly  212 , is provided to enhance the system  170  shown previously in  FIG. 13 . When the tip  230  of the syringe  226  is inserted into the pressurization port  232 , fluid communication between the syringe  226  and the relief valve is established. The relief valve is then pressurized by the syringe  226  to a pre-determined pressure limited by air discharging from the pressure relief port  234 . That regulated pressured air flows through a one-way check valve into the plunger housing  178  and against the plunger  180  to apply a controlled force in the direction of the arrow against the hemostatic STATSEAL tablet  10  held in place over the puncture by the radial band assembly  172  to arrest blood flow and seal the puncture. 
         [0210]    The pressure relief-controlled balloon  248  of  FIGS. 16 and 17  applies pressure against the radial artery via the STATSEAL tablet  10  with much more control and consistency than by the volume-controlled systems currently on the market. More generally, these embodiments  240  and  270  include a syringe activated check/relief valve regulator assembly  250  or  272  acting as the pressure actuator which may be utilized with any air inflated balloon type product for controlling pressure to achieve reduced time arterial hemostasis. The syringe  252  or  274  may include a pressure regulator valve  254  or  276  built into the top or barrel of the syringe for adjusting the air pressure entering the balloon  248 . 
         [0211]    In  FIG. 16 , one embodiment of a consolidated syringe-activated radial artery hemostatic system is shown generally at numeral  240  and is a combination pressure regulator assembly  250  and a radial arm band assembly  242 . When the tip  256  of syringe  252  is inserted into the pressurization port  258 , fluid communication between the syringe  226  and the adjustable pressure regulator  254  is established. When the adjustable pressure regulator  254  is pressurized by the syringe  252  to a pressure limit as established by the adjustment knob  264  of the pressure regulator  254 , the pressurized air either flows into and through the check valve or, when pressure is exceeded, flows out of the pressure relief port  260 . Air pressure flowing out of the check valve  262  at the predetermined pressure then flows into the balloon  248  through a balloon inlet  264  attached to, and extending from, a support plate  246  to apply the predetermined pressure against the puncture of the partially collapsed or collapsed artery R through the STATSEAL tablet  10 . The check valve  262  prevents backflow of air from the balloon once the balloon has been properly pressurized. Thus, the combination of the hemostatic action of the STATSEAL tablet  10  and the regulated pressure applied by the syringe  252  into the balloon  248  against the transdermal puncture in the direction of the arrow combine to more efficiently and effectively arrest blood flow and to seal the puncture. 
         [0212]    Referring to  FIG. 17 , another consolidated embodiment of a flexible VELCRO strap  244  holds the radial arm band assembly  242  around the patient&#39;s wrist. A resilient or semi-flexible support plate  246  spans over the puncture and artery R to position an integrally formed balloon inlet  264  directly over the puncture. The radial arm band assembly  242  is part of another consolidated radial artery hemostatic system  270 . The system  270  also includes a pressure regulator  272  arranged in close proximity to the tip  282  of syringe  274 . An adjustable pressure regulator  276  is connected to the tapering end of syringe  274  adjacent the tip  282  and provides regulated pressure adjustment through adjustment knob  278 . Pressure which exceeds the preset pressure limit is discharged through the pressure relief port  280  in the direction of the arrow. 
         [0213]    Airflow into the check valve  286  from the rigid tip  282  through the pressurization port  284  then is transferred into the collapsible balloon  248  through the balloon inlet  264 . The regulated air pressure, unable to leak back into the syringe  274  by the check valve  286 , then exerts a pressure in the direction of the arrow against the hemostatic tablet  10 , translated against the puncture and the collapsed or partially collapsed radial artery, to effect quick and effective hemostasis of the puncture. 
         [0214]    Referring to  FIGS. 18A-B  and  19 A-B, syringe assemblies  290  and  320  are there shown for use with any air pressure-activated radial arm band adapted to receive a STATSEAL tablet  10  or  12  or WOUNDSEAL hemostatic powder. In  FIGS. 18A-B , the assembly  290  includes a syringe body  292  with a syringe pressure tube  294  which defines a syringe chamber  310 . A transparent sight tube  296  is attached to, and coextensive with, the outside of the syringe pressure tube  294 . The syringe chamber  310  is in fluid communication with a syringe discharge pressure portion  316  of the sight tube  296  via an air transfer passage  300 . A floating or movable pressure indicator  298  is sealingly and slidably positioned within the sight tube  296  whereby, when the syringe nozzle  302  and the air discharge port  304  are connected to e.g., a balloon of a radial arm band as previously described, the air pressure created in the port  304  will be the same as that produced within the syringe chamber  310  by pressing on the end of a plunger  312  sealed by a plunger seal  314  to the inner surface of the syringe chamber  310 , and the syringe discharge pressure portion  316 . The pressure indicator  298  will thereby be slidably moved and be viewable against pressure calibration scale printed along the sight tube  298 , to thereby provide viewable indicia of the pressure created within the e.g., balloon to effect hemostasis of the bleeding puncture as previously described. 
         [0215]    In  FIGS. 19A-B , a syringe assembly  320  functions similar to the syringe assembly  290  previously described and includes a plunger assembly  322  having a plunger seal  330  for moving pressurized air through the syringe chamber  342  from the syringe nozzle  346  through an air pressure port  332  and into a e.g., a balloon. The air discharge port  332  is also in fluid communication with a syringe discharge pressure portion  336  on one side of a sealingly, slidably movable pressure indicator  328  within a transparent sight pressure tube  326  coextensive within the plunger  326 . Pressure created within the syringe chamber  342  is thereby viewably reflected by the position of the movable pressure indicator  328  within the sight chamber  334 . 
       Protocol 
       [0216]    The current recommended protocol for achieving hemostasis in a relatively short amount of time as compared to current practice with respect to a radial arterial vascular puncture is as follows: 
         [0000]    Tablet Separate from Band: 
         [0217]    1) Use a transparent dressing to secure the tablet over the radial site. 
         [0218]    2) Apply the band. 
         [0219]    3) Pull the sheath while inflating or tightening the band to the desired pressure
       a. Ensure that the band does not occlude the ulnar artery       
 
         [0221]    4) After 30 mins slowly deflate or loosen the band, and observe the site for hematoma formation. 
       Tablet Attached to Band: 
       [0222]    1) Apply the band ensuring that the tablet is centered over the radial site. 
         [0223]    2) Pull the sheath while inflating or tightening the band to the desired pressure.
       a. Ensure that the band does not occlude the ulnar artery       
 
         [0225]    3) After 30 mins slowly deflate or loosen the band, and observe the site for hematoma formation. 
         [0226]    An alternate procedure for  FIGS. 16 and 17  may include: 
         [0227]    1) Apply 200 mmHg in balloon for 15 mins 
         [0228]    2) Reduce pressure to 100 mmHg in balloon for 15 mins 
         [0229]    3) Reduce pressure to 50 mmHg in balloon for 15 mins 
         [0230]    4) 0 mmHg 
         [0231]    While a number of exemplary aspects and embodiments have been discussed above, those skilled in the art will recognize certain modifications, permutations and additions and subcombinations thereof. It is therefore intended that the following appended claims and claims hereinafter introduced are interpreted to include all such modifications, permutations, additions and subcombinations that are within their true spirit and scope.