Patent Publication Number: US-2022226001-A1

Title: Balloon assembly for use in a hemostasis band

Description:
RELATED APPLICATIONS 
     This application is a continuation of U.S. patent application Ser. No. 14/452,650 filed on Aug. 6, 2014, which is a continuation in part of U.S. patent application Ser. No. 14/016,034, filed on Aug. 30, 2013, which is a continuation in part of U.S. patent application Ser. No. 13/769,733 filed on Feb. 18, 2013, which claims the benefit of U.S. Provisional Application No. 61/634,772 filed on Mar. 6, 2012 and U.S. Provisional Application No. 61/695,291 filed on Aug. 30, 2012. U.S. patent application Ser. No. 14/452,650 filed on Aug. 6, 2014 is also a continuation in part of U.S. patent application Ser. No. 13/769,733 filed on Feb. 18, 2013, which claims the benefit of U.S. Provisional Application No. 61/634,772 filed on Mar. 6, 2012 and U.S. Provisional Application No. 61/695,291 filed on Aug. 30, 2012. All of the foregoing U.S. patent applications and U.S. Provisional applications are hereby incorporated herein in their entireties. 
    
    
     BACKGROUND OF THE INVENTION 
     The invention relates generally to hemostasis. More specifically, the invention is a balloon assembly that can be combined with a band assembly to form a hemostasis band that is used to apply pressure on a puncture site to facilitate hemostasis of the puncture site. 
     I. Hemostasis 
     Hemostasis means the “stoppage of bleeding or hemorrhage”. Human beings and other animals require the flow of blood to sustain life. Blood loss can be fatal to a patient, but steps taken to stem the loss of blood in a patient can also negatively impact the flow of blood in the patient. The amount of pressure on the puncture site required to perform hemostasis can vary based on the location of the puncture site and the cause of the bleeding. 
     II. Different Causes of Bleeding 
     There are many contexts in the providing of healthcare to patients when it is necessary to address bleeding or hemorrhage of a patient. Regardless of the cause of the bleeding, information about the flow of blood through and around the puncture site can be highly useful to providers in the treatment of patients undergoing hemostasis. 
     A. Bleeding that Results from a Patient Condition 
     In many instances, bleeding is the result of a medical condition of the patient. Examples of bleeding caused by the medical condition of a patient can include diseases, disorders, injuries, allergies, and other conditions that providers seek to address (collectively “conditions”). 
     B. Bleeding that Results from Medical Treatment 
     Bleeding can also result from the providing of medical treatment and/or the subjecting of the patient to certain types of diagnostic tests. Whether the healthcare activity is undertaken for the purposes of diagnosis (such as a blood test) or treatment (such as the injection of medicine into the patient), activities performed by health care providers (collectively “treatment”) can result in bleeding that must be addressed. 
     C. Intravascular Catheterizations 
     Intravascular catheterization includes the catheterization of either the arterial or venous systems for diagnosis or treatment of diseases for all systems and organs of the body, such as cardiovascular, neural (brain), pulmonary (lungs), renal (kidneys) and peripheries. Cardiac catheterization is a subset of intravascular catheterization used to diagnose and treat heart conditions. According the Centers for Disease Control and Prevention, heart disease is the leading cause of death in the United States. Cardiac catheterization involves inserting small tubes (“catheters”) into the circulatory system of the patient. Using X-ray guidance and other sensors, information about blood flow and blood pressure is obtained. Dyes can be injected into the circulatory system for the purpose of identifying the existence of obstructions such as atherosclerotic plaque within blood vessels. On the basis of the location and number of obstructions, a treatment plan for the patient is devised. Such a treatment plan can utilize different devices, such as the placement of a stent to maintain vessel patency, specialized medications, and/or surgery. 
     At the beginning of the catheterization procedure a doctor will puncture the vessel to gain access. After gaining access, the necessary catheters are inserted through the “access site” or “puncture site”. At the end of the catheterization procedure and after all the catheters are removed, the puncture site must be properly closed. A conventional bandage is insufficient because an artery will bleed out through the bandage because it cannot apply sufficient pressure. The proper amount of pressure, or force, needs to be applied at the puncture site to stop bleeding. The pressure can be applied manually by a health care professional holding pressure with their hand, or a medical device or apparatus can be used to apply pressure. 
     Cardiac catheterization and other types of intravascular catheterization are commonly performed through either a puncture site the femoral artery in the groin (“femoral catheterization”) or the radial artery in the wrist (“radial catheterization”). 
     1. Femoral Catheterization 
     Femoral catheterization has traditionally been the more common catheterization because the femoral artery is large and the femoral artery provides a direct route to the heart. However, femoral catheterization can require the patient to lie flat without bending their leg for up to 8 hours during recovery. In some cases, there are bleeding complications with femoral catheterization even when the patient fully complies with the immobility restrictions. 
     2. Radial Catheterization 
     Radial catheterization involves a puncture site located on the radial artery. Radial catheterization has many advantages over femoral catheterization, including less bleeding complications, improved outcomes and reduced costs. Unlike with femoral catheterization, radial catheterization does not require the patient to be immobile. Moreover, patients find radial catheterization to be the more comfortable option because they are free to sit up, walk around, and even eat. 
     III. Prior Art Weaknesses 
     Hemostasis can literally be a matter of life and death. Yet, the prior art does not provide doctors and other health care providers with the most convenient and effective tools for applying hemostasis to a puncture site. 
     SUMMARY OF THE INVENTION 
     The invention relates generally to hemostasis. More specifically, the invention is a balloon assembly that can be combined with a band assembly to form a hemostasis band that is used to apply pressure on a puncture site and assist in achieving hemostasis. 
     The band assembly can be connected to the balloon assembly by inserting the band assembly into one or more openings in the balloon assembly. The balloon assembly can be positioned appropriately with respect to the band assembly, forming a hemostasis band that can provide pressure on a puncture site. One or more balloons on the balloon assembly can be inflated to apply pressure on the puncture site after the balloon and hemostasis band are properly positioned. 
     The band assembly and balloon assembly can be implemented in a wide variety of different embodiments that are highly modular and configurable. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       Many features and inventive aspects of (1) the balloon assembly itself, (2) the balloon assembly in conjunction with a band assembly to form a hemostasis band, and (3) a method for using the hemostasis band are disclosed in the Figures described briefly below. However, no patent application can disclose all of the potential embodiments of an invention. In accordance with the provisions of the patent statutes, the principles and modes of operation of the balloon assembly, the band assembly, the aggregate hemostasis band, and the method of use thereof are explained and illustrated in certain preferred embodiments. However, it must be understood that the structures and methods described above may be practiced otherwise than is specifically explained and illustrated without departing from its spirit or scope. Each of the various elements described in the index/glossary of Table 1 below can be implemented in a variety of different ways while still being consistent with the spirit and scope of the invention. For example, a hemostasis band comprised of the balloon assembly and the band assembly can be implemented in far more different ways using far more different components in far more different configurations than what is illustrated in the accompanying figures. 
       All of the element numbers used in the Figures discussed below are listed and described the index/glossary of element numbers provided as Table 1 below. 
         FIG. 1 a    is a block diagram illustrating an example of interaction between a patient and healthcare provider using a hemostasis band that is comprised of a balloon assembly and a band assembly. 
         FIG. 1 b    is an environmental diagram illustrating an example of a puncture site involving the radial artery during a radial catheterization procedure. 
         FIG. 1 c    is a flow chart diagram illustrating an example of a process for utilizing a hemostasis band with a balloon assembly that can be positioned with respect to a band assembly. 
         FIG. 2 a    is a block diagram illustrating an example of different components that can be included as part of a balloon assembly. 
         FIG. 2 b    is a diagram illustrating an example of a top view of a balloon assembly that includes a sheath, a tube, and a valve. 
         FIG. 2 c    is a diagram illustrating an example of a top view of a balloon assembly that includes a slot as an opening but does not include a sheath 
         FIG. 2 d    is a diagram illustrating an example of a top view of a balloon assembly that includes a slit as an opening and a sheath that encloses a balloon. 
         FIG. 2 e    is a diagram illustrating an example of top view of a balloon assembly that includes a slit as an opening and a sheath that encloses a balloon. 
         FIG. 2 f    is a diagram illustrating an example of a top view of a balloon assembly that includes a slot as an opening, a window over the balloon, but does not include a sheath. 
         FIG. 2 g    is a diagram illustrating an example of a side view of a balloon that is inflated over a puncture site. 
         FIG. 3 a    is a block diagram illustrating an example of different components that can be included as part of the band assembly. 
         FIG. 3 b    is a diagram illustrating an example of a top view of a band assembly in the form of a single rectangular strip. 
         FIG. 3 c    is a diagram illustrating an example of a side view of a band assembly in the form of a continuous elastic loop. 
         FIG. 3 d    is a diagram illustrating an example of a side view of a band assembly that includes two segments connected by a hinge. 
         FIG. 3 e    is a diagram illustrating an example of a perspective view of a foam pad. 
         FIG. 3 f    is a diagram illustrating an example of a perspective view of a balloon pad. 
         FIG. 3 g    is a diagram illustrating an example of a side view of a band assembly in an open position. 
         FIG. 3 h    is a diagram illustrating an example of a top view of a band assembly in an open position. 
         FIG. 4 a    is a diagram illustrating an example of a side view of a hemostasis band in an open state that is comprised of a balloon assembly and a band assembly 
         FIG. 4 b    is a diagram illustrating an example of a perspective view of a hemostasis band in an open state that is comprised of a balloon assembly and a band assembly. 
         FIG. 4 c    is a diagram illustrating an example of a perspective view of a hemostasis band in an open state that is comprised of a balloon assembly and a band assembly. 
         FIG. 4 d    is a diagram illustrating an example of a top view of a hemostasis band in an open state that is comprised of a balloon assembly and a band assembly. 
         FIG. 4 e    is a diagram illustrating an example of a side view of a hemostasis band in a closed state that is comprised of a balloon assembly and a band assembly. 
         FIG. 4 f    is a diagram illustrating an example of a perspective view of a hemostasis band in a closed state that is comprised of a balloon assembly and a band assembly. 
         FIG. 5  is a flow chart diagram illustrating an example for using a hemostasis band that is comprised of a balloon assembly and a band assembly. 
     
    
    
     DETAILED DESCRIPTION 
     The invention relates generally to hemostasis. More specifically, the invention is a balloon assembly that can be combined with a band assembly to form a hemostasis band that is used to apply pressure on a puncture site. 
     I. Overview 
       FIG. 1 a    is a block diagram illustrating an example of interaction between a patient  90  and healthcare provider  92  using a hemostasis band  100  that is comprised of a balloon assembly  200  and a band assembly  300 . Figure  Ibis  an environmental diagram illustrating an example of a puncture site  89  involving the radial artery  91  during a radial catheterization procedure. The hemostasis process involves placing the hemostasis band  100  on the puncture site  89  so that pressure can be placed on the puncture site  89  to stop bleeding at the puncture site  89 . 
     A. Hemostasis Band—Achieving Hemostasis 
     The hemostasis band  100  is an apparatus that can be secured to the body of the patient  90  while the hemostasis band  100  is used to apply pressure to achieve hemostasis, a process by which the bleeding of the patient  90  is stopped. While the hemostasis band  100  stops bleeding, the body of the patient  90  will naturally close the puncture site  89  incision into the radial artery  91 . This “closing” of the puncture site  89  usually takes 1˜4 hours depending on patient conditions and medications administered during the catheterization procedure. After the puncture site  89  has closed, the hemostasis band  100  can be removed from the patient  90  and there will be no bleeding. 
     1. Balloon Assembly 
     The balloon assembly  200  provides for the functionality of pressurizing the hemostasis band  100  by inflating the balloon assembly  200 . The position of the balloon assembly  200  can be moved/adjusted with respect to the band assembly  300 . In some embodiments of the balloon assembly  200 , it is manufactured separately from the band assembly  300  and the hemostasis band  100  is assembled together by the provider  90  or someone else at the location of the patient  90 . In other embodiments, the balloon assembly  200  and band assembly  300  are manufactured, sold, transported, and used as a unit. 
     In many embodiments of the balloon assembly  200 , it is the balloon assembly  200  that is in direct contact with the puncture site  89  during the hemostasis process. In other embodiments, a surface or component in the band assembly  300  can be in direct contact with the puncture site  89  of the patient  90 . 
     2. Band Assembly 
     The band assembly  300  provides for all functions of the hemostasis band  100  that are unrelated to the inflation/deflation of the balloon assembly  200 . Among other functions, the band assembly  300  provides the “band” structure of the hemostasis band  100 . The band assembly  300  secures the position of the hemostasis band  100  to the patient  90  even if it is the balloon assembly  200  that is in direct contact with the puncture site  89  of the patient  90 . 
     B. Features/Advantages 
     The hemostasis band  100  can be implemented with a variety of useful features and attributes. 
     1. Modularity 
     The hemostasis band  100  can be comprised of two highly or even fully modular assemblies, the balloon assembly  200  and the band assembly  300 . The balloon assembly  200  and the band assembly  300  can be manufactured separately and combined as needed by providers  92 . The hemostasis band  100  can be configured to allow a balloon assembly  200  to be used with multiple band assemblies  300 , and vice versa. 
     2. Adjustments 
     The balloon assembly  200  can be moved to a variety of different positions on the band assembly  300 . This flexibility can be utilized before the hemostasis band  100  is secured on the puncture site  89 , during the hemostasis process while the band  100  is on the patient  90 , after the hemostasis process is complete while the band  100  is on the patient  90 , or even after the band  100  has been removed from the patient  90 . 
     3. Transparency 
     The hemostasis band  100 , and its various assemblies and components, can be implemented with a wide variety of different materials. Some embodiments of the band  100  can utilize transparent or at least substantially transparent materials. This can allow providers  92  to see the puncture site  89  even while the hemostasis band  100  is performing hemostasis on the puncture site  89 . This visibility can help the provider  92  to avoid the undesirable extremes of too little pressure being applied to the puncture site  89  or too much pressure being applied to the puncture site  89 . 
     C. Process Flow 
       FIG. 1 c    is a flow chart diagram illustrating an example of a process  500  for utilizing a hemostasis band  100  with a balloon assembly  200  that can be positioned with respect to a band assembly  300 . 
     At  520 , the balloon assembly  200  is positioned relative to the band assembly  300 . 
     At  540 , the band assembly  300  is secured to the body of the patient  90 . 
     At  550 , the balloon assembly  200  is inflated. This increases the pressure on the puncture site  89 , which results in the process of hemostasis being achieved on the puncture site  89 . 
     II. Balloon Assembly 
       FIG. 2 a    is a block diagram illustrating an example of different components that can be included as part of a balloon assembly  200 . All of the elements identified below are also discussed in greater detail in the index/glossary of element numbers provided as Table 1 below. 
     In the aggregate, the function of the balloon assembly  200  is to allow a provider  90  to apply pressure to the puncture site  89 . This can be done by inflating the balloon assembly  200 . The balloon assembly  200  will also have the function to adjust the applied pressure as necessary. During the hemostasis process, the pressure in the balloon assembly  200  can be increased or decreased as needed. 
     A. Balloon 
     The balloon assembly  200  can include a varying number of balloons  210 . In many embodiments, the balloon assembly  200  will include only one balloon  210 , but in alternative embodiments, other configurations can be used. The balloon  210  will often be the component of the band  100  that is in direct contact with the puncture site  89 , applying pressure over the incision. The pressure stops bleeding while the body naturally closes the incision in the skin and artery 
     The balloons  210  incorporated into the balloon assembly  200  can be comprised in a variety of shapes, sizes, and dimensions. A wide range of materials and manufacturing processes can be used to create the balloons  210  used by the assembly  200 . 
     A balloon  210  can be made by RF (radio frequency) welding two layers of polymer film together. The RF welding creates the seal around the perimeter of the balloon. RF technology can be used on materials that have the correct form of dipolar molecules. The radio frequency excites the molecules imparting energy which causes the material to go from a solid to liquid state. After the RF input is stopped, the material cools back to a solid state creating a weld between the two layers of polymer. 
     The balloon  210  could be manufactured using a blow molding method. Blow molding is valuable for apparatuses that have a cavity or hollow area. Common examples are bottles, containers or larger polymer structures that are hollow. Some children toys are made using blow molding. Medical devices can also be made using blow molding, such as medical bottles, or containers for blood or bodily fluids. It is envisioned that the balloon  210  component for the band can be made using a blow molding manufacturing method. 
     The balloon  210  could be manufactured using a dip molding method. A dipping mandrel in the shape of the balloon  210  can be made. The mandrel would be dipped into a vat containing liquid polymer. Some of the polymer would adhere to the mandrel. Repetitive dipping adds layers of polymer. When the desired thickness of balloon has been achieved, it can be removed from the mandrel, thus creating the balloon  210 . 
     Examples of balloons can be seen in  FIGS. 2 a -2 g   . If a balloon  210  is neither transparent nor at least semi-transparent, the balloon  210  can include a substantially transparent window  212  (see  FIG. 2 f   ) that allows for a provider  90  to see the puncture site  89  under the band  100  while hemostasis is being performed. 
     B. Opening 
     Returning to  FIG. 2 a   , the balloon assembly  200  will include an opening  220  through which the band assembly  300  can be positioned. Many embodiments of the balloon assembly  200  will include two or even more openings  220 . Openings  220  facilitate the ability of the balloon assembly  200  and the band assembly  300  to be combined into a single hemostasis band  100 . Many openings  220  can be characterized as being either slits  222  or slots  224 . Examples of openings  220  are illustrated in  FIGS. 2 a   - 2   f.    
     1. Slits 
     A slit  222  is a narrow cut-like opening in the balloon assembly  200 . Analogous to a button hole, such an opening  220  often requires manual prodding to create sufficient open space for the band assembly  300  to be positioned into the opening  220 . Examples of slits  222  are illustrated in  FIGS. 2 a , 2 d   , and  2   e.    
     2. Slots 
     A slot  224  is a more substantial opening  224  than a slit  222 . A slot  224  does not require manual prodding to create space. Examples of slots  224  are illustrated in  FIGS. 2 b , 2 c   , and  2   f.    
     3. Members 
     The space of an opening  220  is often shaped by a member  226  that is exterior to the opening  220 . Such members  226  can be configured in a wide variety of different shapes, sizes, types of materials, etc. Examples of members  226  are illustrated in  FIGS. 2 a -2 d   , and  2   f.    
     C. Sheath 
     Returning to  FIG. 2 a   , the balloon assembly  200  can include a sheath  250  that is used to house the balloon  210 , openings  220 , and potentially other parts of the balloon assembly  200 . The sheath  250  can be comprised of virtually any material used to make the balloon  210  or the members  226 . Examples of sheaths  250  are illustrated in  FIGS. 2 a , 2 b , 2 d   , and  2   e.    
     D. Inlet 
     Returning to  FIG. 2 a   , the balloon assembly  200  can include an inlet  230  that provides for the inflation and deflation of the balloon  210 . Examples of inlets  230  are illustrated and expressly identified in  FIGS. 2 a   - 2   d.    
     1. Tube 
     A tube  232  can make it easier and more convenient to inflate and/or deflate the balloon  210 . The tube  232  allows inflation and deflation to take place further away from the body of the patient  90 . An example of a tube  232  is illustrated in  FIGS. 2 a   - 2   b.    
     2. Valve 
     A valve  234  can make it easier for the balloon  210  to stay inflated as well as to be deflated. The valve  234  can possess a variety of operating modes such as fully open, fully closed, and a variety of operating states in between. 
     E. Drawings of Balloon Assembly 
       FIG. 2 b    is a diagram illustrating an example of a top view of a balloon assembly  200  that includes a sheath  250 , a tube  232 , and a valve  234 . 
       FIG. 2 c    is a diagram illustrating an example of a top view of a balloon assembly  200  that includes a slot  224  as an opening  220  but does not include a sheath  250 . 
       FIG. 2 d    is a diagram illustrating an example of a top view of a balloon assembly  200  that includes a slit  222  as an opening  220  and a sheath  250  that encloses a balloon  210 . 
       FIG. 2 e    is a diagram illustrating an example of top view of a balloon assembly  200  that includes a slit  222  as an opening  220  and a sheath  250  that encloses a balloon  210 . 
       FIG. 2 f    is a diagram illustrating an example of a top view of a balloon assembly  200  that includes a slot  224  as an opening  220  but does not include a sheath  250 . 
       FIG. 2 g    is a diagram illustrating an example of a side view of a balloon  210  that is inflated over a puncture site  89 . 
     III. Band Assembly 
     The band assembly  300  is the portion of the hemostasis band  100  that comprises the band itself (comprised of one more segments  330 ), as well as providing the structures for securing the hemostasis band  100  onto the patient  90 . The band assembly  300  can be implemented in a wide variety of different structures, from a simple elastic band that holds the balloon assembly  200  in place to a complex assembly that includes sensors, electronic communications, computer processors, and other components that may be useful to the hemostasis process, whether directly or indirectly. 
       FIG. 3 a    is a block diagram illustrating an example of different components that can be included as part of the band assembly  300 . As illustrated in  FIG. 3 a   , the band assembly  300  can include a fastener component  310 , including but not limited to a hook and loop fastener  312  commonly referred to as VELCRO®, a hinge  320  that connects segments  330  of the band  100  together, and padding components  340  such as a foam pad  342  or a balloon pad  344 . 
     The components of the band assembly  300  can be manufactured using injection molding methods or die cut from stock material. 
     A. Fastener Component 
     A fastener component  310  is a portion of the band assembly  300  that is used to secure the band assembly  300  on the patient  90 . A mechanism or component of the band assembly  300  by which the band assembly  300  and the hemostasis band  100  as a whole, can be secured to the patient  90 . Many embodiments of the band assembly  300  will require some type of fastener component  310 . In some embodiments of the band assembly  300 , the segment  330  of the assembly  300  is an elastic band that serves at its own fastener to the patient  90 . In other embodiments, the band assembly  300  will use a snap, button, zipper, adhesive surface, hook and loop fastener  312 , or other similar technology to secure two ends of the band assembly  300  together while the balloon assembly  200  is secured to the band assembly  300 . Examples of fastener components  310  are illustrated in  FIGS. 3 a , 3 g   , and  3   h,    
     B. Hinge 
     If a band assembly  300  includes two or more segments  330 , one or more hinges  320  can be used to link those segments together. The functionality of the hinge  320  allows one segment  330  to move with respect to another. That movement and positioning can provide for a band  100  being opened and closed. Thus, the hinge  320  can be an important aid in securing the position of the band  100  on the patient  90 . Examples of hinges  320  are illustrated in  FIGS. 3 a , 3 d , 3 g   , and  3   h.    
     In many embodiments of the hinge  320 , the hinge  320  will be an actual hinge that includes a hinge pin. In other embodiments, the hinge  320  can implement a “living hinge” concept where the function is equivalent to a hinge without having the express structural components of a hinge. 
     C. Segment 
     The band assembly  300  can be comprised of one, two, or even more segments  330  which can also be referred to as “band segments” or “band surfaces”. Some embodiments of a band  100  can involve a single segment  330  that could be fashioned with a fastener component  310  on each end (see  FIG. 3 b   ) or even a single segment  330  that is an elastic loop (see  FIG. 3 c   ). Other embodiments of the band assembly  300  will often involve two or more segments  330  and one or more hinges  320 . 
     Many embodiments of rigid or at least partially rigid segments  330  will involve curved segments  330 . Examples of segments  330  can include a flexible elastic band, a strip, a loop, a semi-flexible/semi-rigid band, and a fully rigid band. Segments  330  can serve as the relevant surface of the band assembly  300  that various components are attached to (virtually all of the components of the band assembly  300 ) as well as the relevant portion of the band assembly  300  that moves within the openings  220  and with respect to the balloon assembly  200 . A segment  330  that is curved can be referred to as a curved segment  332 . 
     Segments  330  can be implemented in wide variety of different shapes, sizes, materials, transparency levels, etc. 
     D. Padding Component 
     Returning to  FIG. 3 a   , the band assembly  300  can also include as few as zero padding components up to as many padding components  340  that can fit on the various segments  330  of the band  100 . Padding components  340  exist for the purpose of the comfort of the patient  90 . Examples of padding components  340  can include a foam pad  342  or a balloon pad  344  (i.e. an additional balloon). The pad component and closure mechanism can be manufactured with more than one method. Either could be molded, die cut, rotary die cut or water jet cut. The components would have the same feature regardless of manufacturing method. 
     E. Band Assembly Drawings 
       FIG. 3 b    is a diagram illustrating an example of a top view of a band assembly  300  in the form of a single rectangular strip as the sole segment  330 . 
       FIG. 3 c    is a diagram illustrating an example of a side view of a band assembly  300  with a single segment  330  in the form of a continuous elastic loop. 
       FIG. 3 d    is a diagram illustrating an example of a side view of a band assembly  300  that includes two segments  330  connected by a hinge  320 . 
       FIG. 3 e    is a diagram illustrating an example of a perspective view of a foam pad  342 . 
       FIG. 3 f    is a diagram illustrating an example of a perspective view of a balloon pad  344 . 
       FIG. 3 g    is a diagram illustrating an example of a side view of a band assembly  300  in an open position. 
       FIG. 3 h    is a diagram illustrating an example of a top view of a band assembly  300  in an open position. 
     IV. Hemostasis Band as a Mechanism for Hemostasis 
     The hemostasis band  100  can be implemented in a wide variety of different embodiments with utilizing different components, component configurations, materials, geometries, and other attributes. For some embodiments of the band  100 , components can be manufactured using injection molding methods or die cut from stock material. 
       FIG. 4 a    is a diagram illustrating an example of a side view of a hemostasis band  100  in an open state that is comprised of a balloon assembly  200  and a band assembly  300 . In terms of the balloon assembly  200 , there is a balloon  210  illustrated with a valve  234 . The positions of two slots  224  are also illustrated. The entire balloon assembly  200  is positioned on one segment  330  between the hinge  320  and the fastening component  312  of the band assembly  300 . The band assembly  300  includes a hinge  320  connecting two segments  330 , a fastening component  312  comprised of two straps of VELCRO® material fixed to those two segments  330 . A foam pad  342  is fixed to one of the segments  330 . 
       FIG. 4 b    is a diagram illustrating an example of a perspective view of a hemostasis band  100  in an open state that is comprised of a balloon assembly  200  and a band assembly  300 . The band  100  of  FIG. 4 b    is essentially identical to  FIG. 4 a   , except that the illustrations are taken from different points of view. 
       FIG. 4 c    is a diagram illustrating an example of a perspective view of a hemostasis band  100  in an open state that is comprised of a balloon assembly  200  and a band assembly  300 . The band  100  of  FIG. 4 c    is substantially identical to the band  100  of  FIGS. 4 a  and 4 b   , differing primarily in point of view.  FIG. 4 c    illustrates the spatial relationship between the balloon  210 , the two openings  220  of the balloon assembly  200 , and the segment  330  positioned between the two openings  220 . 
       FIG. 4 d    is a diagram illustrating an example of a top view of a hemostasis band  100  in an open state that is comprised of a balloon assembly  200  and a band assembly  300 . The band  100  of  FIG. 4 d    is substantially identical to the band  100  of  FIGS. 4 a -4 c   , differing primarily in point of view. 
       FIG. 4 e    is a diagram illustrating an example of a side view of a hemostasis band  100  in a closed state that is comprised of a balloon assembly  200  and a band assembly  300 .  FIG. 4 e    illustrates a closed band  100  where  FIG. 4 a    illustrates an open band  100  from the same orientation. 
       FIG. 4 f    is a diagram illustrating an example of a perspective view of a hemostasis band  100  in a closed state that is comprised of a balloon assembly  200  and a band assembly  300 .  FIG. 4 f    corresponds close to  FIG. 4 b   , with the primary difference being in the operating state of the band  100 . 
     V. Process Flow View 
       FIG. 5  is a flow chart diagram illustrating an example for using a hemostasis band  100  that is comprised of a balloon assembly  200  and a band assembly  300 . 
     At  510 , the band assembly  300  can be inserted into one or more openings  220  in the balloon assembly  200 , securing in a non-permanent way, the combination forming the hemostasis band  100 . 
     At  520 , the balloon assembly  200  is positioned with respect to the band assembly  300 . This is typically done by sliding the one or more openings  220  along one or more segments  330 . 
     At  530 , the band assembly  300  is secured on the patient  90 , a process by which the band  100  is also secured on the patient  90 . This process can include positioning the band  100  on the patient  90  and securing that position by closing the fastener components  310 . In many instances of many embodiments, the balloon  210  will be positioned over the puncture site  89 . 
     At  540 , the balloon assembly  200  can be repositioned with respect to the band assembly  300  for the purposes of properly configuring and positioning the band  100  for providing hemostasis at the puncture site  89 . 
     At  550 , the one or more balloons  210  of the balloon assembly  200  are inflated. With embodiments involving a balloon pad  344 , the balloon pad  344  can also be inflated at this time, or at a time prior to the inflating of the pressurizing balloon  210 . 
     At  560 , hemostasis is performed by the band  100 , which can be adjusted as desired in terms of magnitude of pressure or the position of the balloon  210  or other component with direct contact to the puncture site  89 . 
     At  570 , the balloon  210  can be deflated. This can either be purposeful and active, or the end result of the balloons  210  inherent structure to slow leak air over a period of time. 
     At  580 , the band can be removed from the patient  90 . This is done by unfastening the fastener component  310  and removing the band  100  from the patient. 
     At  590 , the balloon assembly  200  and the band assembly  300  can be separated from each other and disposed of, cleaned, etc. as appropriate. 
     The process is then complete. 
     VI. Glossary/Index 
     Table 1 below provides a chart of element numbers, element names, and element descriptions. 
     
       
         
           
               
               
               
             
               
                   
               
               
                 Element 
                   
                   
               
               
                 Number 
                 Name 
                 Description 
               
               
                   
               
             
            
               
                   
               
            
           
           
               
               
               
            
               
                 89 
                 Puncture Site 
                 A location on the patient 90 for which hemostasis is 
               
               
                   
                   
                 performed to prevent blood loss. In the context of 
               
               
                   
                   
                 catheterizations, the term “arteriotomy” is synonymous with 
               
               
                   
                   
                 the term “puncture site”. 
               
               
                 90 
                 Patient 
                 A living organism, typically a human being, subject to a 
               
               
                   
                   
                 hemostasis process. 
               
               
                 91 
                 Radial Artery 
                 A blood vessel on a human patient 90 used to perform 
               
               
                   
                   
                 radial catheterization. The puncture site 89 for a radial 
               
               
                   
                   
                 catheterization procedure is a location on the Radial Artery 
               
               
                   
                   
                 91 near a patient&#39;s 90 wrist. 
               
               
                 92 
                 Provider 
                 A doctor, nurse, nurse practitioner, catheterization lab 
               
               
                   
                   
                 technician, physician assistant, paramedic, or other person 
               
               
                   
                   
                 involved in performing hemostasis on a patient 90. 
               
               
                 100 
                 Hemostasis 
                 An apparatus formed when the band assembly 300 is 
               
               
                   
                 Band 
                 inserted into one or more openings 220 in the balloon 
               
               
                   
                   
                 assembly 200. The hemostasis band 100 can be 
               
               
                   
                   
                 implemented using a variety of different materials including 
               
               
                   
                   
                 cloth, plastic, rubber, metal, steel, and ceramic. The 
               
               
                   
                   
                 hemostasis band 100 can also be referred to simply as the 
               
               
                   
                   
                 band 100. Some embodiments of the band 100 can be 
               
               
                   
                   
                 implemented such that the band is transparent or at least 
               
               
                   
                   
                 substantially transparent. This can aid providers 92 in 
               
               
                   
                   
                 preparing as well as monitoring the hemostasis process. 
               
               
                   
                   
                 In some embodiments of the band 100, the surfaces of the 
               
               
                   
                   
                 hemostasis band 100 that come into contact with the skin 
               
               
                   
                   
                 of a patient 90 can be coated with anti-adhesive coatings 
               
               
                   
                   
                 to prevent the band 100 from sticking to the skin of the 
               
               
                   
                   
                 patient 90. 
               
               
                 200 
                 Balloon 
                 An assembly 200 that provides for combining with a band 
               
               
                   
                 Assembly 
                 assembly 300 to form a hemostasis band 100. The 
               
               
                   
                   
                 balloon assembly 200 includes one or more openings 220 
               
               
                   
                   
                 into which the band assembly 300 can be inserted into or 
               
               
                   
                   
                 connected through. The balloon assembly 200 can include 
               
               
                   
                   
                 at least one balloon 210, at least one opening 220 for the 
               
               
                   
                   
                 band assembly 300, and at least one inlet 230 for the 
               
               
                   
                   
                 inflation of the balloon 210. The balloon assembly 200 
               
               
                   
                   
                 serves to pressurize the hemostasis band 100 after the 
               
               
                   
                   
                 band 100 is properly positioned on the patient 90. 
               
               
                 210 
                 Balloon 
                 The balloon 210 can be the mechanism within the 
               
               
                   
                   
                 hemostasis band 100 by which pressure is placed on the 
               
               
                   
                   
                 puncture site 89. Balloons 210 are typically configured to 
               
               
                   
                   
                 be inflated with gasses such as air or liquids such as 
               
               
                   
                   
                 water, however balloons 210 can also be inflated with solid 
               
               
                   
                   
                 fluids such as gelatinous or substantially gelatinous 
               
               
                   
                   
                 materials. Balloons 210 can be comprised of a wide 
               
               
                   
                   
                 variety of materials, including but not limited to plastic, 
               
               
                   
                   
                 rubber, or latex. In many embodiments, it is the surface of 
               
               
                   
                   
                 the balloon 210 that comes into direct physical contact with 
               
               
                   
                   
                 the puncture site 89 of the patient 90. In many 
               
               
                   
                   
                 embodiments, the balloon 210 will be transparent or at 
               
               
                   
                   
                 least substantially transparent to permit the puncture site 
               
               
                   
                   
                 89 to be seen by the provider 92 when (1) positioning the 
               
               
                   
                   
                 band 100 over the puncture site 89; (2) inflating the balloon 
               
               
                   
                   
                 21O; and (3) monitoring the hemostasis process after the 
               
               
                   
                   
                 balloon is inflated. 
               
               
                 212 
                 Window 
                 Embodiments of balloon assembly 200 with an opaque 
               
               
                   
                   
                 balloon 210 may include a transparent or at least 
               
               
                   
                   
                 substantially transparent window 212 to permit the provider 
               
               
                   
                   
                 to see the puncture site 89 of the patient 90. 
               
               
                 220 
                 Opening 
                 A space within the balloon assembly 200 that allows for 
               
               
                   
                   
                 the insertion of the band assembly 300 into the balloon 
               
               
                   
                   
                 assembly 200 and for the sliding of the balloon assembly 
               
               
                   
                   
                 200 along the band assembly 300. Many embodiments of 
               
               
                   
                   
                 the balloon assembly 200 will include two openings 220, 
               
               
                   
                   
                 but the balloon assembly 200 can have as few as one 
               
               
                   
                   
                 opening 220 or as many as three or more openings 220. 
               
               
                 222 
                 Slits 
                 A thin opening 220 with the thickness of a cut. Analogous 
               
               
                   
                   
                 to a button hole, a human being will often need to manually 
               
               
                   
                   
                 pry open a slit 222 before the band assembly 300 can be 
               
               
                   
                   
                 inserted. 
               
               
                 224 
                 Slots 
                 An opening 220 that is wider than a slit 222. A slot 224 is 
               
               
                   
                   
                 a permanent opening that unlike a slit 222, is sustained 
               
               
                   
                   
                 without being manually pried open. 
               
               
                 226 
                 Members 
                 A surface area or structure adjacent to a slot 224 that 
               
               
                   
                   
                 shapes the slot 224. Members 226 of all different shapes 
               
               
                   
                   
                 and sizes can be used to create an opening 220 of the 
               
               
                   
                   
                 desired shape and size. 
               
               
                 230 
                 Inlet 
                 A pathway into the balloon 210 that allows for the inflation 
               
               
                   
                   
                 and deflation of the balloon 210. The inlet 230 of the 
               
               
                   
                   
                 balloon 210 may in some embodiments be filled with a 
               
               
                   
                   
                 tube 232. 
               
               
                 232 
                 Tube 
                 A passageway to the inlet 230. Use of the tube 232 can 
               
               
                   
                   
                 permit the inflation and deflation of the balloon 210 to 
               
               
                   
                   
                 occur at a greater distance from the surface of the balloon 
               
               
                   
                   
                 210. The tube 232 can also make it easier for a valve 234 
               
               
                   
                   
                 to be used as part of the balloon assembly 200. In some 
               
               
                   
                   
                 embodiments, the tube 232 is a separate and distinct 
               
               
                   
                   
                 component of the balloon assembly 200. In other 
               
               
                   
                   
                 embodiments, the tube 232 can simply be the neck of the 
               
               
                   
                   
                 balloon 210. The structure and functionality of the tube 
               
               
                   
                   
                 232 can be achieved using a balloon 210 with a similarly 
               
               
                   
                   
                 structured neck. 
               
               
                 234 
                 Valve 
                 A device that can be included in the balloon assembly 200 
               
               
                   
                   
                 that can control the flow into and out of the balloon 210. A 
               
               
                   
                   
                 typical valve will have at least two operating states, an 
               
               
                   
                   
                 operating state of being closed/sealed and an operating 
               
               
                   
                   
                 state of being open/unsealed. Some embodiments of the 
               
               
                   
                   
                 valve 234 may operate in a linear fashion between the two 
               
               
                   
                   
                 extreme states of totally closed/totally sealed and totally 
               
               
                   
                   
                 open/totally unsealed. Valves 234 can be made up of a 
               
               
                   
                   
                 wide variety of different materials, including but not limited 
               
               
                   
                   
                 to metal, rubber, plastic, and ceramic. Some valves 234 
               
               
                   
                   
                 can include a pressure sensor. 
               
               
                 250 
                 Sheath 
                 A cover for some or all of the balloon assembly 200. For 
               
               
                   
                   
                 example, the balloon 210, openings 220, and inlet 230 can 
               
               
                   
                   
                 each be integrated into a single sheath 250 that prevents 
               
               
                   
                   
                 the individual removal of any of the integrated 
               
               
                   
                   
                 components. 
               
               
                 300 
                 Band Assembly 
                 An assembly 300 that provides for combining with a 
               
               
                   
                   
                 balloon assembly 200 to form a hemostasis band 100. In 
               
               
                   
                   
                 many embodiments, the band assembly 300 is removable 
               
               
                   
                   
                 from the balloon assembly 200 and it is the band assembly 
               
               
                   
                   
                 300 which serves to secure the hemostasis band 100 on 
               
               
                   
                   
                 the puncture site 89 of the patient 90. In some 
               
               
                   
                   
                 embodiments, some portion of the band assembly 300 
               
               
                   
                   
                 comes into direct contact with the puncture site 89, 
               
               
                   
                   
                 although it many embodiments it is the balloon 210 of the 
               
               
                   
                   
                 balloon assembly 200 that is intended to come into direct 
               
               
                   
                   
                 contact with the puncture site 89 on the patient 90. 
               
               
                 310 
                 Fastener 
                 A mechanism or component of the band assembly 300 by 
               
               
                   
                 Component 
                 which the band assembly 300 and the hemostasis band 
               
               
                   
                   
                 100 as a whole, can be secured to the patient 90. Many 
               
               
                   
                   
                 embodiments of the band assembly 300 will require some 
               
               
                   
                   
                 type of fastener component 310. In some embodiments of 
               
               
                   
                   
                 the band assembly 300, the segment 330 of the assembly 
               
               
                   
                   
                 300 is an elastic band that serves at its own fastener to the 
               
               
                   
                   
                 patient 90. In other embodiments, the band assembly 300 
               
               
                   
                   
                 will use a snap, button, zipper, adhesive surface, hook and 
               
               
                   
                   
                 loop fastener 312, or other similar technology to secure 
               
               
                   
                   
                 two ends of the band assembly 300 together while the 
               
               
                   
                   
                 balloon assembly 200 is secured to the band assembly 
               
               
                   
                   
                 300. 
               
               
                 312 
                 Hook and Loop 
                 A type of fastener made out of two strips of VELCO ® 
               
               
                   
                 Fastener 
                 material. 
               
               
                 320 
                 Hinge 
                 A joint that links one segment 330 of the band assembly to 
               
               
                   
                   
                 another segment 330. The hinge 320 permits relative 
               
               
                   
                   
                 movement between the two or more seqments 330. 
               
               
                 330 
                 Segment 
                 A surface on the band assembly 300 that can also be 
               
               
                   
                   
                 referred to as the “band” of the band assembly 300. Many 
               
               
                   
                   
                 embodiments of the band assembly 300 will include two 
               
               
                   
                   
                 segments 330 joined by a hinge 320, although some 
               
               
                   
                   
                 alternative embodiments can include as few as one 
               
               
                   
                   
                 segment 330 (an elastic loop for example) or more than 
               
               
                   
                   
                 two segments 330. Segments 330 can be flexible, rigid, or 
               
               
                   
                   
                 partially rigid/partially flexible. Many embodiments of rigid 
               
               
                   
                   
                 or at least partially rigid segments 330 will involve curved 
               
               
                   
                   
                 segments 330. Examples of segments 330 can include a 
               
               
                   
                   
                 flexible elastic band, a strip, a loop, a semi-flexible/semi- 
               
               
                   
                   
                 rigid band, and a fully rigid band. Segments 330 can also 
               
               
                   
                   
                 be referred to as “body components” 330 as segments 
               
               
                   
                   
                 serve as the relevant surface of the band assembly 300 
               
               
                   
                   
                 that various components are attached to (virtually all of the 
               
               
                   
                   
                 components of the band assembly 300) as well as the 
               
               
                   
                   
                 relevant portion of the band assembly 300 that moves 
               
               
                   
                   
                 within the openings 220 and with respect to the balloon 
               
               
                   
                   
                 assembly 200. 
               
               
                 332 
                 Curved 
                 A segment 330 that is at least semi-rigid such that it can 
               
               
                   
                 Seqment 
                 maintain an at least somewhat curved shape. 
               
               
                 340 
                 Padding 
                 A mechanism to enhance the comfort of the patient 90 with 
               
               
                   
                 Component 
                 respect to the apparatus 100 and the band assembly 300. 
               
               
                   
                   
                 Examples of padding components include a foam pad 342, 
               
               
                   
                   
                 a second balloon, and other types of active or passive 
               
               
                   
                   
                 padding materials. 
               
               
                 342 
                 Foam Pad 
                 An example of a padding component 340 
               
               
                 344 
                 Balloon Pad 
                 An example of a padding component 340. 
               
               
                   
               
            
           
         
       
     
     VII. Alternative Embodiments 
     No patent application can disclose all of the potential embodiments of an invention. In accordance with the provisions of the patent statutes, the principles and modes of operation of the balloon assembly  200 , the band assembly  300 , the aggregate hemostasis band  100 , and the method  500  of use thereof are explained and illustrated in certain preferred embodiments. However, it must be understood that the hemostasis band  100 , balloon assembly  200 , band assembly  300 , and method  500  of their use may be practiced otherwise than is specifically explained and illustrated without departing from its spirit or scope. Each of the various elements described in the index above can be implemented in a variety of different ways while still being consistent with the spirit and scope of the invention. For example, a hemostasis band  100  comprised of the balloon assembly  200  and the band assembly  300  can be implemented in far more different ways using far more different components in far more different configurations than what is illustrated in the accompanying figures. 
     The description of the apparatus provided above should be understood to include all novel and non-obvious combination of elements described therein, and claims may be presented in this or a later application to any novel non-obvious combination of these elements. Moreover, the foregoing embodiments are illustrative, and no single feature or element is essential to all possible combinations that may be claimed in this or a later application.