US20220117609A9 - Balloon assembly for use in a hemostasis band - Google Patents
Balloon assembly for use in a hemostasis band Download PDFInfo
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- US20220117609A9 US20220117609A9 US14/452,650 US201414452650A US2022117609A9 US 20220117609 A9 US20220117609 A9 US 20220117609A9 US 201414452650 A US201414452650 A US 201414452650A US 2022117609 A9 US2022117609 A9 US 2022117609A9
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- assembly
- balloon
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/132—Tourniquets
- A61B17/135—Tourniquets inflatable
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/132—Tourniquets
- A61B17/1322—Tourniquets comprising a flexible encircling member
- A61B17/1325—Tourniquets comprising a flexible encircling member with means for applying local pressure
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00831—Material properties
- A61B2017/00902—Material properties transparent or translucent
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Abstract
Description
- This utility patent application claims priority to the following patent applications which are hereby incorporated by reference in their entirety: (1) the provisional patent application titled “FLEXIBLE HOLOGRAM USING ROOM LIGHTS WHICH DETECTS ARTERY PULSATION” (Ser. No. 61/634,772) filed on Mar. 6, 2012; (2) the provisional patent application titled “HEMOSTASIS APPARATUS AND METHOD” (Ser. No. 61/695,291) filed on Aug. 30, 2012; (3) the utility patent application titled “HEMOSTASIS APPARATUS AND METHOD” (Ser. No. 13/769,733) filed on Feb. 18, 2013; and (4) the utility patent application titled “HEMOSTASIS SENSOR AND METHOD OF USE THEREOF” (Ser. No. 14/016,034) filed on Aug. 30, 2013.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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. 1a 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. 1b is an environmental diagram illustrating an example of a puncture site involving the radial artery during a radial catheterization procedure. -
FIG. 1c 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. 2a is a block diagram illustrating an example of different components that can be included as part of a balloon assembly. -
FIG. 2b is a diagram illustrating an example of a top view of a balloon assembly that includes a sheath, a tube, and a valve. -
FIG. 2c 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. 2d 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. 2e 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. 2f 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. 2g is a diagram illustrating an example of a side view of a balloon that is inflated over a puncture site. -
FIG. 3a is a block diagram illustrating an example of different components that can be included as part of the band assembly. -
FIG. 3b is a diagram illustrating an example of a top view of a band assembly in the form of a single rectangular strip. -
FIG. 3c is a diagram illustrating an example of a side view of a band assembly in the form of a continuous elastic loop. -
FIG. 3d is a diagram illustrating an example of a side view of a band assembly that includes two segments connected by a hinge. -
FIG. 3e is a diagram illustrating an example of a perspective view of a foam pad. -
FIG. 3f is a diagram illustrating an example of a perspective view of a balloon pad. -
FIG. 3g is a diagram illustrating an example of a side view of a band assembly in an open position. -
FIG. 3h is a diagram illustrating an example of a top view of a band assembly in an open position. -
FIG. 4a 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. 4b 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. 4c 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. 4d 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. 4e 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. 4f 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. - 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. 1a is a block diagram illustrating an example of interaction between a patient 90 andhealthcare provider 92 using ahemostasis band 100 that is comprised of aballoon assembly 200 and aband assembly 300.FIG. 1b is an environmental diagram illustrating an example of apuncture site 89 involving theradial artery 91 during a radial catheterization procedure. The hemostasis process involves placing thehemostasis band 100 on thepuncture site 89 so that pressure can be placed on thepuncture site 89 to stop bleeding at thepuncture 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 thehemostasis band 100 is used to apply pressure to achieve hemostasis, a process by which the bleeding of thepatient 90 is stopped. While thehemostasis band 100 stops bleeding, the body of the patient 90 will naturally close thepuncture site 89 incision into theradial artery 91. This “closing” of thepuncture site 89 usually takes 1-4 hours depending on patient conditions and medications administered during the catheterization procedure. After thepuncture site 89 has closed, thehemostasis band 100 can be removed from thepatient 90 and there will be no bleeding. - 1. Balloon Assembly
- The
balloon assembly 200 provides for the functionality of pressurizing thehemostasis band 100 by inflating theballoon assembly 200. The position of theballoon assembly 200 can be moved/adjusted with respect to theband assembly 300. In some embodiments of theballoon assembly 200, it is manufactured separately from theband assembly 300 and thehemostasis band 100 is assembled together by theprovider 90 or someone else at the location of thepatient 90. In other embodiments, theballoon assembly 200 andband assembly 300 are manufactured, sold, transported, and used as a unit. - In many embodiments of the
balloon assembly 200, it is theballoon assembly 200 that is in direct contact with thepuncture site 89 during the hemostasis process. In other embodiments, a surface or component in theband assembly 300 can be in direct contact with thepuncture site 89 of thepatient 90. - 2. Band Assembly
- The
band assembly 300 provides for all functions of thehemostasis band 100 that are unrelated to the inflation/deflation of theballoon assembly 200. Among other functions, theband assembly 300 provides the “band” structure of thehemostasis band 100. Theband assembly 300 secures the position of thehemostasis band 100 to the patient 90 even if it is theballoon assembly 200 that is in direct contact with thepuncture site 89 of thepatient 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, theballoon assembly 200 and theband assembly 300. Theballoon assembly 200 and theband assembly 300 can be manufactured separately and combined as needed byproviders 92. Thehemostasis band 100 can be configured to allow aballoon assembly 200 to be used withmultiple band assemblies 300, and vice versa. - 2. Adjustments
- The
balloon assembly 200 can be moved to a variety of different positions on theband assembly 300. This flexibility can be utilized before thehemostasis band 100 is secured on thepuncture site 89, during the hemostasis process while theband 100 is on thepatient 90, after the hemostasis process is complete while theband 100 is on thepatient 90, or even after theband 100 has been removed from thepatient 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 theband 100 can utilize transparent or at least substantially transparent materials. This can allowproviders 92 to see thepuncture site 89 even while thehemostasis band 100 is performing hemostasis on thepuncture site 89. This visibility can help theprovider 92 to avoid the undesirable extremes of too little pressure being applied to thepuncture site 89 or too much pressure being applied to thepuncture site 89. - C. Process Flow
-
FIG. 1c is a flow chart diagram illustrating an example of aprocess 500 for utilizing ahemostasis band 100 with aballoon assembly 200 that can be positioned with respect to aband assembly 300. - At 520, the
balloon assembly 200 is positioned relative to theband assembly 300. - At 540, the
band assembly 300 is secured to the body of thepatient 90. - At 550, the
balloon assembly 200 is inflated. This increases the pressure on thepuncture site 89, which results in the process of hemostasis being achieved on thepuncture site 89. - II. Balloon Assembly
-
FIG. 2a is a block diagram illustrating an example of different components that can be included as part of aballoon 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 aprovider 90 to apply pressure to thepuncture site 89. This can be done by inflating theballoon assembly 200. Theballoon assembly 200 will also have the function to adjust the applied pressure as necessary. During the hemostasis process, the pressure in theballoon assembly 200 can be increased or decreased as needed. - A. Balloon
- The
balloon assembly 200 can include a varying number ofballoons 210. In many embodiments, theballoon assembly 200 will include only oneballoon 210, but in alternative embodiments, other configurations can be used. Theballoon 210 will often be the component of theband 100 that is in direct contact with thepuncture 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 theballoon 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 theballoons 210 used by theassembly 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 theballoon 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 theballoon 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 theballoon 210. - Examples of balloons can be seen in
FIGS. 2a -2 g. If aballoon 210 is neither transparent nor at least semi-transparent, theballoon 210 can include a substantially transparent window 212 (seeFIG. 2f ) that allows for aprovider 90 to see thepuncture site 89 under theband 100 while hemostasis is being performed. - B. Opening
- Returning to
FIG. 2 a, theballoon assembly 200 will include anopening 220 through which theband assembly 300 can be positioned. Many embodiments of theballoon assembly 200 will include two or evenmore openings 220.Openings 220 facilitate the ability of theballoon assembly 200 and theband assembly 300 to be combined into asingle hemostasis band 100.Many openings 220 can be characterized as being eitherslits 222 orslots 224. Examples ofopenings 220 are illustrated inFIGS. 2a -2 f. - 1. Slits
- A
slit 222 is a narrow cut-like opening in theballoon assembly 200. Analogous to a button hole, such anopening 220 often requires manual prodding to create sufficient open space for theband assembly 300 to be positioned into theopening 220. Examples ofslits 222 are illustrated inFIGS. 2 a, 2 d, and 2 e. - 2. Slots
- A
slot 224 is a moresubstantial opening 224 than aslit 222. Aslot 224 does not require manual prodding to create space. Examples ofslots 224 are illustrated inFIGS. 2 b, 2 c, and 2 f. - 3. Members
- The space of an
opening 220 is often shaped by amember 226 that is exterior to theopening 220.Such members 226 can be configured in a wide variety of different shapes, sizes, types of materials, etc. Examples ofmembers 226 are illustrated inFIGS. 2a -2 d, and 2 f. - C. Sheath
- Returning to
FIG. 2 a, theballoon assembly 200 can include asheath 250 that is used to house theballoon 210,openings 220, and potentially other parts of theballoon assembly 200. Thesheath 250 can be comprised of virtually any material used to make theballoon 210 or themembers 226. Examples ofsheaths 250 are illustrated inFIGS. 2 a, 2 b, 2 d, and 2 e. - D. Inlet
- Returning to
FIG. 2 a, theballoon assembly 200 can include aninlet 230 that provides for the inflation and deflation of theballoon 210. Examples ofinlets 230 are illustrated and expressly identified inFIGS. 2a -2 d. - 1. Tube
- A
tube 232 can make it easier and more convenient to inflate and/or deflate theballoon 210. Thetube 232 allows inflation and deflation to take place further away from the body of thepatient 90. An example of atube 232 is illustrated inFIGS. 2a -2 b. - 2. Valve
- A
valve 234 can make it easier for theballoon 210 to stay inflated as well as to be deflated. Thevalve 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. 2b is a diagram illustrating an example of a top view of aballoon assembly 200 that includes asheath 250, atube 232, and avalve 234. -
FIG. 2c is a diagram illustrating an example of a top view of aballoon assembly 200 that includes aslot 224 as anopening 220 but does not include asheath 250. -
FIG. 2d is a diagram illustrating an example of a top view of aballoon assembly 200 that includes aslit 222 as anopening 220 and asheath 250 that encloses aballoon 210. -
FIG. 2e is a diagram illustrating an example of top view of aballoon assembly 200 that includes aslit 222 as anopening 220 and asheath 250 that encloses aballoon 210. -
FIG. 2f is a diagram illustrating an example of a top view of aballoon assembly 200 that includes aslot 224 as anopening 220 but does not include asheath 250. -
FIG. 2g is a diagram illustrating an example of a side view of aballoon 210 that is inflated over apuncture site 89. - III. Band Assembly
- The
band assembly 300 is the portion of thehemostasis band 100 that comprises the band itself (comprised of one more segments 330), as well as providing the structures for securing thehemostasis band 100 onto thepatient 90. Theband assembly 300 can be implemented in a wide variety of different structures, from a simple elastic band that holds theballoon 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. 3a is a block diagram illustrating an example of different components that can be included as part of theband assembly 300. As illustrated inFIG. 3 a, theband assembly 300 can include afastener component 310, including but not limited to a hook andloop fastener 312 commonly referred to as VELCRO®, ahinge 320 that connectssegments 330 of theband 100 together, andpadding components 340 such as afoam pad 342 or aballoon 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 theband assembly 300 that is used to secure theband assembly 300 on thepatient 90. A mechanism or component of theband assembly 300 by which theband assembly 300 and thehemostasis band 100 as a whole, can be secured to thepatient 90. Many embodiments of theband assembly 300 will require some type offastener component 310. In some embodiments of theband assembly 300, thesegment 330 of theassembly 300 is an elastic band that serves at its own fastener to thepatient 90. In other embodiments, theband assembly 300 will use a snap, button, zipper, adhesive surface, hook andloop fastener 312, or other similar technology to secure two ends of theband assembly 300 together while theballoon assembly 200 is secured to theband assembly 300. Examples offastener components 310 are illustrated inFIGS. 3 a, 3 g, and 3 h, - B. Hinge
- If a
band assembly 300 includes two ormore segments 330, one ormore hinges 320 can be used to link those segments together. The functionality of thehinge 320 allows onesegment 330 to move with respect to another. That movement and positioning can provide for aband 100 being opened and closed. Thus, thehinge 320 can be an important aid in securing the position of theband 100 on thepatient 90. Examples ofhinges 320 are illustrated inFIGS. 3 a, 3 d, 3 g, and 3 h. - In many embodiments of the
hinge 320, thehinge 320 will be an actual hinge that includes a hinge pin. In other embodiments, thehinge 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 evenmore segments 330 which can also be referred to as “band segments” or “band surfaces”. Some embodiments of aband 100 can involve asingle segment 330 that could be fashioned with afastener component 310 on each end (seeFIG. 3b ) or even asingle segment 330 that is an elastic loop (seeFIG. 3c ). Other embodiments of theband assembly 300 will often involve two ormore segments 330 and one or more hinges 320. - Many embodiments of rigid or at least partially
rigid segments 330 will involvecurved segments 330. Examples ofsegments 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 theband 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 theband assembly 300 that moves within theopenings 220 and with respect to theballoon assembly 200. Asegment 330 that is curved can be referred to as acurved 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, theband assembly 300 can also include as few as zero padding components up to asmany padding components 340 that can fit on thevarious segments 330 of theband 100. Paddingcomponents 340 exist for the purpose of the comfort of thepatient 90. Examples ofpadding components 340 can include afoam 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. 3b is a diagram illustrating an example of a top view of aband assembly 300 in the form of a single rectangular strip as thesole segment 330. -
FIG. 3c is a diagram illustrating an example of a side view of aband assembly 300 with asingle segment 330 in the form of a continuous elastic loop. -
FIG. 3d is a diagram illustrating an example of a side view of aband assembly 300 that includes twosegments 330 connected by ahinge 320. -
FIG. 3e is a diagram illustrating an example of a perspective view of afoam pad 342. -
FIG. 3f is a diagram illustrating an example of a perspective view of aballoon pad 344. -
FIG. 3g is a diagram illustrating an example of a side view of aband assembly 300 in an open position. -
FIG. 3h is a diagram illustrating an example of a top view of aband assembly 300 in an open position. - 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 theband 100, components can be manufactured using injection molding methods or die cut from stock material. -
FIG. 4a is a diagram illustrating an example of a side view of ahemostasis band 100 in an open state that is comprised of aballoon assembly 200 and aband assembly 300. In terms of theballoon assembly 200, there is aballoon 210 illustrated with avalve 234. The positions of twoslots 224 are also illustrated. Theentire balloon assembly 200 is positioned on onesegment 330 between thehinge 320 and thefastening component 312 of theband assembly 300. Theband assembly 300 includes ahinge 320 connecting twosegments 330, afastening component 312 comprised of two straps of VELCRO® material fixed to those twosegments 330. Afoam pad 342 is fixed to one of thesegments 330. -
FIG. 4b is a diagram illustrating an example of a perspective view of ahemostasis band 100 in an open state that is comprised of aballoon assembly 200 and aband assembly 300. Theband 100 ofFIG. 4b is essentially identical toFIG. 4 a, except that the illustrations are taken from different points of view. -
FIG. 4c is a diagram illustrating an example of a perspective view of ahemostasis band 100 in an open state that is comprised of aballoon assembly 200 and aband assembly 300. Theband 100 ofFIG. 4c is substantially identical to theband 100 ofFIGS. 4a and 4 b, differing primarily in point of view.FIG. 4c illustrates the spatial relationship between theballoon 210, the twoopenings 220 of theballoon assembly 200, and thesegment 330 positioned between the twoopenings 220. -
FIG. 4d is a diagram illustrating an example of a top view of ahemostasis band 100 in an open state that is comprised of aballoon assembly 200 and aband assembly 300. Theband 100 ofFIG. 4d is substantially identical to theband 100 ofFIGS. 4a -4 c, differing primarily in point of view. -
FIG. 4e is a diagram illustrating an example of a side view of ahemostasis band 100 in a closed state that is comprised of aballoon assembly 200 and aband assembly 300.FIG. 4e illustrates aclosed band 100 whereFIG. 4a illustrates anopen band 100 from the same orientation. -
FIG. 4f is a diagram illustrating an example of a perspective view of ahemostasis band 100 in a closed state that is comprised of aballoon assembly 200 and aband assembly 300.FIG. 4f corresponds close toFIG. 4 b, with the primary difference being in the operating state of theband 100. -
FIG. 5 is a flow chart diagram illustrating an example for using ahemostasis band 100 that is comprised of aballoon assembly 200 and aband assembly 300. - At 510, the
band assembly 300 can be inserted into one ormore openings 220 in theballoon assembly 200, securing in a non-permanent way, the combination forming thehemostasis band 100. - At 520, the
balloon assembly 200 is positioned with respect to theband assembly 300. This is typically done by sliding the one ormore openings 220 along one ormore segments 330. - At 530, the
band assembly 300 is secured on thepatient 90, a process by which theband 100 is also secured on thepatient 90. This process can include positioning theband 100 on thepatient 90 and securing that position by closing thefastener components 310. In many instances of many embodiments, theballoon 210 will be positioned over thepuncture site 89. - At 540, the
balloon assembly 200 can be repositioned with respect to theband assembly 300 for the purposes of properly configuring and positioning theband 100 for providing hemostasis at thepuncture site 89. - At 550, the one or
more balloons 210 of theballoon assembly 200 are inflated. With embodiments involving aballoon pad 344, theballoon pad 344 can also be inflated at this time, or at a time prior to the inflating of the pressurizingballoon 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 theballoon 210 or other component with direct contact to thepuncture site 89. - At 570, the
balloon 210 can be deflated. This can either be purposeful and active, or the end result of theballoons 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 thefastener component 310 and removing theband 100 from the patient. - At 590, the
balloon assembly 200 and theband assembly 300 can be separated from each other and disposed of, cleaned, etc. as appropriate. - The process is then complete.
- Table 1 below provides a chart of element numbers, element names, and element descriptions.
-
Element Number Name Description 89 Puncture A location on the patient 90 for which hemostasis isSite 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 A blood vessel on a human patient 90 used to performArtery radial catheterization. The puncture site 89 for a radialcatheterization procedure is a location on the Radial Artery 91 near a patient'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 isBand inserted into one or more openings 220 in theballoon assembly 200. The hemostasis band 100 can beimplemented 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 theband 100. Some embodiments of theband 100 can beimplemented such that the band is transparent or at least substantially transparent. This can aid providers 92 inpreparing as well as monitoring the hemostasis process. In some embodiments of the band 100, the surfaces of thehemostasis band 100 that come into contact with the skinof a patient 90 can be coated with anti-adhesive coatings to prevent the band 100 from sticking to the skin of thepatient 90.200 Balloon An assembly 200 that provides for combining with a band Assembly assembly 300 to form a hemostasis band 100. Theballoon assembly 200 includes one ormore openings 220into which the band assembly 300 can be inserted into orconnected through. The balloon assembly 200 can includeat least one balloon 210, at least oneopening 220 for theband assembly 300, and at least oneinlet 230 for theinflation of the balloon 210. Theballoon assembly 200serves to pressurize the hemostasis band 100 after theband 100 is properly positioned on thepatient 90.210 Balloon The balloon 210 can be the mechanism within thehemostasis band 100 by which pressure is placed on thepuncture site 89.Balloons 210 are typically configured tobe 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 widevariety 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 withthe puncture site 89 of thepatient 90. In manyembodiments, the balloon 210 will be transparent or atleast substantially transparent to permit the puncture site 89 to be seen by the provider 92 when (1) positioning theband 100 over thepuncture site 89; (2) inflating theballoon 210; and (3) monitoring the hemostasis process after the balloon is inflated. 212 Window Embodiments of balloon assembly 200 with anopaque balloon 210 may include a transparent or at least substantially transparent window 212 to permit the providerto see the puncture site 89 of thepatient 90.220 Opening A space within the balloon assembly 200 that allows forthe insertion of the band assembly 300 into theballoon assembly 200 and for the sliding of the balloon assembly 200 along the band assembly 300. Many embodiments ofthe balloon assembly 200 will include twoopenings 220,but the balloon assembly 200 can have as few as oneopening 220 or as many as three ormore openings 220.222 Slits A thin opening 220 with the thickness of a cut. Analogousto a button hole, a human being will often need to manually pry open a slit 222 before theband assembly 300 can beinserted. 224 Slots An opening 220 that is wider than aslit 222. Aslot 224 isa permanent opening that unlike a slit 222, is sustainedwithout being manually pried open. 226 Members A surface area or structure adjacent to a slot 224 thatshapes the slot 224.Members 226 of all different shapesand sizes can be used to create an opening 220 of thedesired shape and size. 230 Inlet A pathway into the balloon 210 that allows for the inflationand deflation of the balloon 210. Theinlet 230 of theballoon 210 may in some embodiments be filled with atube 232.232 Tube A passageway to the inlet 230. Use of thetube 232 canpermit the inflation and deflation of the balloon 210 tooccur at a greater distance from the surface of the balloon 210. The tube 232 can also make it easier for avalve 234to be used as part of the balloon assembly 200. In someembodiments, the tube 232 is a separate and distinctcomponent of the balloon assembly 200. In otherembodiments, the tube 232 can simply be the neck of theballoon 210. The structure and functionality of thetube 232 can be achieved using a balloon 210 with a similarlystructured neck. 234 Valve A device that can be included in the balloon assembly 200that can control the flow into and out of the balloon 210. Atypical 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 twoextreme states of totally closed/totally sealed and totally open/totally unsealed. Valves 234 can be made up of awide variety of different materials, including but not limited to metal, rubber, plastic, and ceramic. Some valves 234can include a pressure sensor. 250 Sheath A cover for some or all of the balloon assembly 200. Forexample, the balloon 210,openings 220, andinlet 230 caneach be integrated into a single sheath 250 that preventsthe individual removal of any of the integrated components. 300 Band An assembly 300 that provides for combining with a Assembly balloon assembly 200 to form a hemostasis band 100. Inmany embodiments, the band assembly 300 is removablefrom the balloon assembly 200 and it is theband assembly 300 which serves to secure the hemostasis band 100 onthe puncture site 89 of thepatient 90. In someembodiments, some portion of the band assembly 300comes into direct contact with the puncture site 89,although it many embodiments it is the balloon 210 of theballoon assembly 200 that is intended to come into directcontact with the puncture site 89 on thepatient 90.310 Fastener A mechanism or component of the band assembly 300 byComponent which the band assembly 300 and thehemostasis band 100 as a whole, can be secured to the patient 90. Manyembodiments of the band assembly 300 will require sometype of fastener component 310. In some embodiments ofthe band assembly 300, thesegment 330 of theassembly 300 is an elastic band that serves at its own fastener to the patient 90. In other embodiments, theband assembly 300will use a snap, button, zipper, adhesive surface, hook and loop fastener 312, or other similar technology to securetwo ends of the band assembly 300 together while theballoon assembly 200 is secured to theband assembly 300. 312 Hook and A type of fastener made out of two strips of VELCO ® Loop material. Fastener 320 Hinge A joint that links one segment 330 of the band assembly toanother segment 330. Thehinge 320 permits relativemovement between the two or more segments 330.330 Segment A surface on the band assembly 300 that can also bereferred to as the “band” of the band assembly 300. Manyembodiments of the band assembly 300 will include twosegments 330 joined by ahinge 320, although somealternative 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, orpartially rigid/partially flexible. Many embodiments of rigid or at least partially rigid segments 330 will involvecurved segments 330. Examples of segments 330 can include aflexible elastic band, a strip, a loop, a semi-flexible/semi- rigid band, and a fully rigid band. Segments 330 can alsobe referred to as “body components” 330 as segments serve as the relevant surface of the band assembly 300that 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 moveswithin the openings 220 and with respect to theballoon assembly 200. 332 Curved A segment 330 that is at least semi-rigid such that it can Segment 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 theband 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 340344 Balloon Pad An example of a padding component 340. - 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, theband assembly 300, theaggregate hemostasis band 100, and themethod 500 of use thereof are explained and illustrated in certain preferred embodiments. However, it must be understood that thehemostasis band 100,balloon assembly 200,band assembly 300, andmethod 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, ahemostasis band 100 comprised of theballoon assembly 200 and theband 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.
Claims (20)
Priority Applications (2)
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US14/452,650 US11311300B2 (en) | 2012-03-06 | 2014-08-06 | Balloon assembly for use in a hemostasis band |
US17/714,355 US20220226001A1 (en) | 2012-03-06 | 2022-04-06 | Balloon assembly for use in a hemostasis band |
Applications Claiming Priority (5)
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US201261634772P | 2012-03-06 | 2012-03-06 | |
US201261695291P | 2012-08-30 | 2012-08-30 | |
US13/769,733 US11701127B2 (en) | 2012-03-06 | 2013-02-18 | Hemostasis apparatus and method |
US14/016,034 US20140012120A1 (en) | 2012-03-06 | 2013-08-30 | Hemostasis sensor and method of use thereof |
US14/452,650 US11311300B2 (en) | 2012-03-06 | 2014-08-06 | Balloon assembly for use in a hemostasis band |
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US14/016,034 Continuation-In-Part US20140012120A1 (en) | 2012-03-06 | 2013-08-30 | Hemostasis sensor and method of use thereof |
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US17/714,355 Continuation US20220226001A1 (en) | 2012-03-06 | 2022-04-06 | Balloon assembly for use in a hemostasis band |
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US20220117609A9 true US20220117609A9 (en) | 2022-04-21 |
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US17/714,355 Pending US20220226001A1 (en) | 2012-03-06 | 2022-04-06 | Balloon assembly for use in a hemostasis band |
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JP7118852B2 (en) * | 2018-10-15 | 2022-08-16 | オムロン株式会社 | Blood pressure measuring device |
US11596417B2 (en) | 2019-02-28 | 2023-03-07 | Terumo Kabushiki Kaisha | Hemostasis band with improved edge design |
WO2021094221A1 (en) * | 2019-11-11 | 2021-05-20 | Telefonaktiebolaget Lm Ericsson (Publ) | False base station detection |
US10828045B1 (en) * | 2020-02-24 | 2020-11-10 | Avraham Zada | Tourniquet device |
CN113262011B (en) * | 2021-05-28 | 2023-09-12 | 中国人民解放军总医院第一医学中心 | Hemostatic device |
CN115153732A (en) * | 2022-07-26 | 2022-10-11 | 刘雄平 | Medical latex air bag of tourniquet for pediatrics |
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US5152302A (en) * | 1991-08-14 | 1992-10-06 | Fareed Donald O | Forearm transaxial compression band |
US5792173A (en) * | 1995-07-10 | 1998-08-11 | Stuart D. Edwards | Wound closure hemostasis device |
JP3818220B2 (en) * | 2002-06-03 | 2006-09-06 | オムロンヘルスケア株式会社 | Wrist blood pressure monitor cuff |
ATE498363T1 (en) * | 2002-07-15 | 2011-03-15 | Terumo Corp | BLOOD STUNKING DEVICE WITH INFLATABLE BALLOON |
WO2008150966A1 (en) * | 2007-06-01 | 2008-12-11 | Virginia Commonwealth University | Device for control of difficult to compress hemorrhage |
US11701127B2 (en) * | 2012-03-06 | 2023-07-18 | Accumed Radial Systems, Llc | Hemostasis apparatus and method |
WO2014081970A1 (en) * | 2012-11-21 | 2014-05-30 | Medical Ingenuities, LLC | Radial compression hemostasis band with doppler confirming vascular patency |
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US20160038154A1 (en) | 2016-02-11 |
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