• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
  • 同族专利
  • 引用文献
  • 法律状态
  • 优先权
    • 专利摘要:
    device and method for collecting a blood sample. a bleed plug is disclosed that includes a body having a distal end, a proximal end, and a lumen extending through the distal and proximal ends. a membrane is disposed across the lumen, the membrane being hydrophobic and permeable to air. a fluid chamber is formed in the distal lumen of the membrane. a distal lumen opening being shaped and sized to hold blood in the lumen until the internal lumen pressure builds up in response to a finger pressing against an opening near the lumen.
    公开号:BR112013001551B1
    申请号:R112013001551-9
    申请日:2011-07-19
    公开日:2021-06-29
    发明作者:Bart D. Peterson；Bryan G. Davis；Jason Austin Mickinnon
    申请人:Becton, Dickinson And Company；
    IPC主号:
    专利说明:

    Background
    [001] The present disclosure relates to bleeding air and blood sampling with vascular access devices. Blood sampling is a common health care procedure involving taking at least one drop of blood from a patient. Blood samples are commonly taken from hospitalized patients, home care and emergency rooms by finger prick, heel prick or venipuncture. After collection, blood samples are analyzed using one or more levels of blood testing.
    [002] Blood tests determine the physiological and biochemical states of the patient, such as disease, mineral content, drug efficacy and organ function. Blood tests can be performed in a laboratory, a distance away from the patient's location, or performed at the point of treatment, close to the patient's location. An example of a point-of-care blood test is the routine testing of a patient's blood glucose levels. This involves drawing blood through a finger prick and mechanically collecting blood into a diagnostic cartridge. The diagnostic cartridge later analyzes the blood sample and provides the clinician with a reading of the patient's blood glucose level. Other devices are available that analyze blood gas electrolyte levels, lithium levels, ionized calcium levels. In addition, some point-of-care devices identify markers for acute coronary syndrome (ACS) and pulmonary embolism/deep vein thrombosis (DVT/PE).
    [003] Despite rapid advances in diagnostics and point-of-care testing, blood sampling techniques have remained relatively unchanged. Blood samples are often taken using hypodermic needles or vacuum tubes attached to a proximal end of a needle or catheter assembly. In some cases, clinicians draw blood from a catheter assembly using a needle and syringe that is inserted into the catheter to draw blood from a patient through the inserted catheter. These procedures use needles and vacuum tubes as intermediate devices from which the collected blood sample is typically taken prior to testing. These processes are thus device intensive, utilizing multiple devices in the process of obtaining, preparing and testing blood samples. In addition, each required device adds time and cost to the testing process. Therefore, there is a need for more efficient blood sampling and testing methods and devices. summary
    [004] The present invention was developed in response to problems and needs in the art that have not yet been fully resolved by currently available vascular access systems and methods. As described here, an exhaust plug can be used to bleed an extravascular system as well as collect a blood sample and later dispense the blood sample. These exhaust plugs can thereby reduce the number of steps and devices required to perform these procedures, which can decrease the time and cost of these procedures.
    [005] In one aspect of the invention, an exhaust plug comprises a body having a distal end, a proximal end, and a lumen extending through the distal and proximal ends. A membrane is disposed across the lumen and the membrane is hydrophobic and air permeable. A fluid chamber is formed in the distal lumen of the membrane. A distal lumen opening is shaped and sized to retain blood in the lumen until the internal lumen pressure increases in response to a finger pressing against a proximal lumen opening.
    [006] The implementation may include one or more of the following aspects. The membrane may be coupled to a proximal lumen opening such that a finger pressing against the proximal lumen opening presses against the membrane. The membrane may be inclined to bulge proximally. The volume of displacement caused when the membrane is pushed distally is at least 0.05 mL. The membrane may be disposed in the lumen, and the membrane may be dividing the lumen into an air chamber proximal to the membrane and a fluid chamber distal to the membrane. The body may include a compressible portion at its proximal end. The compressible portion may form a portion of a surface of the inner tube. The distal lumen opening can have an inner perimeter equal to or less than 2.0 mm. The distal lumen opening may be substantially circular and have a diameter between approximately 0.1 mm and approximately 0.6 mm. The distal lumen opening can be substantially circular and have a diameter between approximately 0.2 mm and approximately 0.3 mm. The fluid chamber can have a volume of at least 0.1 ml.
    [007] In another aspect of the invention, an exhaust plug comprises a body having a distal end, a proximal end, and a lumen extending through the distal and proximal ends. A membrane is disposed across a portion of the lumen in the lumen. The membrane being hydrophobic and permeable to air. The membrane dividing the lumen into an air chamber proximal to the membrane and a fluid chamber distal to the membrane. A distal lumen opening is shaped and sized to hold blood in the fluid chamber until the internal lumen pressure increases in response to a finger pressing against a proximal lumen opening.
    [008] The implementation may include one or more of the following aspects. The body may include a compressible portion at its proximal end, and the compressible portion may form part of a surface of the air chamber. The distal lumen opening can have an inner perimeter equal to or less than 2.0 mm. The distal lumen opening may be substantially circular and may have a diameter between approximately 0.1 mm and approximately 0.6 mm. The distal lumen opening may be substantially circular and may have a diameter between approximately 0.2 mm and approximately 0.3 mm. The fluid chamber can have a volume of at least 0.1 ml.
    [009] In another aspect of the invention, a method for collecting blood samples includes disposing an exhaust plug in an orifice of an intravenous infusion therapy system. The exhaust plug has a body with a lumen therethrough. A membrane is laid across the lumen. The membrane is hydrophobic and permeable to air. An exhaust plug distal lumen opening is shaped and sized to hold blood in the lumen until the internal lumen pressure increases in response to a finger pressing against a proximal lumen opening. The method also includes bleeding air from the intravenous infusion therapy system and at least substantially filling the exhaust plug with blood. The method also includes removing the exhaust plug from the intravenous infusion therapy system. Lastly, the method includes expelling a volume of blood from the exhaust plug by pressing a finger distally into the proximal lumen opening of the exhaust plug.
    [010] The method implementation may include one or more of the following aspects. The membrane can be coupled to the proximal lumen opening and is inclined to bulge closely, and expelling a volume of blood can include tamping the membrane distally. The air-permeable membrane may divide the lumen into an air chamber proximal to the membrane and a fluid chamber distal to the membrane, and where expelling a volume of blood may include increasing the internal pressure of the air chamber. The body may include a compressible proximal portion, and expelling a volume of blood may include compressing the compressible proximal portion of the body.
    [011] These and other aspects and advantages of the present invention may be incorporated into certain embodiments of the invention and will become more fully evident from the following description and appended claims, or may be learned by practicing the invention as set out below. The present invention does not require that all the advantageous aspects and all the advantages described herein be incorporated into every embodiment of the invention. Brief description of the various views of the drawings
    [012] In order that the manner in which the aforementioned and other aspects and advantages of the invention are obtained are readily understood, a more specific description of the invention briefly described above will be made by reference to specific embodiments thereof which are illustrated in the attached drawings. These drawings represent only typical embodiments of the invention and therefore are not to be considered as limiting the scope of the invention.
    [013] Figure 1 is a perspective view of an extravascular system with an exhaust plug, according to some embodiments; Figure 2 is a perspective view of an exhaust plug in an orifice, according to some embodiments; Figure 3 is a cross-sectional view of the exhaust plug and orifice of Figure 2, according to some embodiments; Figure 4 is a cross-sectional view of the exhaust plug of Figures 2 and 3 after removal of the exhaust plug of the orifice, in some embodiments; Figure 5 is a perspective view of fingers holding an exhaust plug and expelling drops of blood therefrom, in some embodiments; Figure 6 is a cross-sectional view of another exhaust plug, according to some embodiments; Figure 7 is a cross-sectional view of the exhaust plug of Figure 6, while blood is being expelled from it with a finger, according to some embodiments; figure 8 is a sectional view the cross-sectional view of another exhaust plug, according to some embodiments; Figure 9 is a cross-sectional view of the exhaust plug of Figure 8, while blood is being expelled from it with a finger, according to some modalities. Detailed description of the invention
    [014] The embodiments of the present invention can be understood by reference to the drawings, in which similar reference numbers indicate identical or functionally similar elements. It will be readily appreciated that the components of the present invention, as generally described and illustrated in the figures herein, could be arranged and designed in a wide variety of different configurations. Thus, the following more detailed description, as represented in the figures, is not intended to limit the scope of the invention as claimed, but is merely representative of currently preferred embodiments of the invention.
    [015] Reference will now be made to Figure 1, which illustrates an extravascular system with which an exhaust plug 42 can be used. It will be understood that the exhaust plug 42 is not limited to the illustrated system, but can be used with other extravascular systems ranging from a simple needle to more complex extravascular devices. from this figure, it is evident that an exhaust plug 42 can, in some configurations, reduce the number of components required to take a diagnostic blood sample from a patient. This is because the exhaust plug 42 combines blood exhaust and blood collection aspects in a single device.
    [016] Figure 1 illustrates an extravascular system 20, such as the BD NEXIVA™ Closed Intravenous (IV) Catheter System, from Becton, Dickinson and Company, which can be accessed by an exhaust plug 42. The illustrated modality of the extravascular system 20 includes multiple vascular access devices such as needle hub 26 coupled to an introducer needle 32 that extends through a catheter assembly 24. Catheter assembly 24 includes a catheter adapter 28 that is coupled to a peripheral, IV catheter , over the needle, 30 extending from it. Introducer needle 32 is left within catheter assembly 24 until catheter 30 is inserted into and correctly positioned in a patient's vasculature, when it is withdrawn. In some embodiments, one or more needle tip protectors are incorporated into the needle hub 26 to protect the needle tip after it is removed from the catheter assembly 24.
    [017] In some configurations, an integrated extension tubing 36 is attached to and provides fluid communication with the catheter assembly 24. Extension tubing 36 may also be attached to an orifice 40 that provides access to the vasculature system of the through extension tubing 36 and catheter assembly 24. Orifice 40 can have various configurations, such as a single-hole Luer adapter, a Luer Y adapter, and other known orifices. In some cases, a clamp 38 is used to selectively close the extension tubing 36. As shown, an exhaust plug 42 can be inserted into port 40.
    [018] Although Figure 1 depicts the exhaust plug 42 coupled to an orifice 40 in an extension tubing 36, the exhaust plug 42 can be coupled to any orifice 40 in fluid connection with a patient's vasculature. Such alternative holes could be located in the catheter assembly 24 directly, or more specifically in the catheter adapter 28. In another extravascular system 20, the holes 40 may be coupled to a needle, catheter, or other components of the extravascular system 20.
    [019] In some embodiments, the exhaust plug 42 bleeds air from the catheter assembly 24 and extension tubing 36 prior to collecting a blood sample therefrom. When catheter assembly 24 establishes fluid communication with a patient's vasculature, internal blood pressure of the vascular system can force blood into catheter assembly 24 and upward into extension tubing 36. In some cases It is desirable to allow such blood to fill catheter assembly 24 and extension tubing 36 to bleed air from extravascular system 20 before fluids are infused through that system into the patient. This process can reduce the likelihood that air will be infused into the patient's vasculature. Therefore, in some embodiments, exhaust plug 42 includes a membrane 44 that is permeable to air, through which air from within extravascular system 20 passes. In some embodiments, the membrane 44 is hydrophobic so that it does not allow blood to pass therethrough. In such embodiments, blood entering extravascular system 20 forces air out of membrane 44 as it enters the system and fills the system to membrane 44 of exhaust plug 42. At that point, in some cases, clip 38 may close. extension tubing 36 while exhaust plug 42 is removed and a separate vascular access device, such as an IV line coupled to a fluid reservoir, is attached to port 40 to begin an IV therapy process.
    [020] As described above, the exhaust plug 42 includes a membrane 44 that can be either air permeable or hydrophobic to allow air, but not blood, to pass through. Membrane 44 can include various materials and components that provide these properties. For example, in some embodiments, membrane 4 includes glass, polyethylene terephthalate (PET), a microfiber material, and/or another synthetic material made from high-density polyethylene fibers such as DuPont's TYVEK® material. Other such materials and components can also be used as a layer of the membrane 44 or as the inner membrane 44 to allow the membrane 44 to be hydrophobic and/or air permeable, in some configurations.
    [021] As illustrated in figures 2 and 3, in addition to bleeding air 63 from the extravascular system 20, the exhaust plug 42 can collect a blood sample 62 in it that can be used for blood testing or other procedures. Figure 2 illustrates a close-up view of the exhaust plug 42 inserted into the opening 70 of an orifice 40 coupled to an extension tube 36, similar to that of Figure 1, and Figure 3 illustrates a cross-sectional view of the devices of Figure 2. As illustrated, exhaust plug 42 can include a body 50 that has a lumen 52 extending between proximal end 46 and distal end 48 of body 50. Body 50 can have a variety of shapes and sizes. As shown, body 50 forms a tapered cylinder, but in other embodiments, body 50 may have other shapes and sizes. In some embodiments, the membrane 44 is disposed and/or coupled to the proximal lumen opening 72 of the body 50, as shown, creating a fluid chamber 68 in the distal lumen 52 of the membrane 44. The membrane 44 may have coupling portion 44b which is coupled to the body 50 of the exhaust plug 42. The membrane 44 may have an exposed portion 44a which is prone to proximally bulge as shown. This exposed portion 44a can bulge outward a sufficient distance 54 to allow the membrane 44 to be pressed by the adult middle finger from the domed position, or pre-compressed position (element 76 in Figure 4), to a compressed position (element 74 in Figure 4), to compress the volume of the fluid chamber sufficiently to expel a drop of blood 84 therefrom, as described below. In some modalities, a drop of blood is at least 0.05 mL. Therefore, in some configurations, the membrane 44 is flexible so that it can be pressed in, as shown in figure 4.
    [022] During exhaustion, as blood 62 is forced into exhaust plug 42, air 64 within lumen 52 is forced through membrane 44 via one or more air flow paths 56. During this process, a sample of blood 62 can be collected in fluid chamber 68. The volume of blood collected can be controlled in part by the size of fluid chamber 68, which can thereby be designed to contain the desired volume of blood. Most blood tests require a minimum of approximately 0.1 µL of blood, therefore, fluid chamber 68 can be at least this size. In other embodiments, fluid chamber 68 is sized to hold up to approximately 10 mL of blood. In other embodiments, fluid chamber 68 may be even larger than 10 ml.
    [023] In some embodiments, exhaust plug 42 may be configured to retain blood 62 as it is withdrawn from orifice 40 to prevent blood spills and blood contamination. Thus, in some configurations, the distal lumen opening 58 is shaped and sized to hold blood 62. Blood retention in lumen 52 is governed, at least in part, by the inner perimeter of the distal lumen opening 58, the surface tension of blood, and the force on blood 62 to flow out of the distal lumen opening 58. Therefore, the inner perimeter of the distal lumen opening 58 can be designed so that blood 62 is retained in the fluid chamber 68 when the force of blood 62 to flow out of the distal lumen opening 58 is comprised in a certain range, but allows at least some blood to flow out when the pressure in blood 62 exceeds that range.
    [024] For example, in some embodiments, when the distal opening of lumen 58 is circular, an internal perimeter less than or equal to approximately 2.0 mm, and a diameter 60 less than or equal to approximately 0.6 mm, allows retention of blood in the 52 lumen against approximately the force of gravity. When the force on blood 62 is greater than the force of gravity some blood 42 may flow out of the distal lumen opening 58. Similarly, a circular lumen distal opening 58 with a diameter of approximately 0.3 mm can retain blood 62 in it against forces stronger than gravity, such as collision, jolt, and movement of the full exhaust plug 42. When the distal lumen opening 58 has a very small internal perimeter, the force required to expel blood 62 will be too big.
    [025] As shown in Figures 4 and 5, in some embodiments, the exhaust plug 42 is capable of expelling blood 62 out of the exhaust plug 42 after being withdrawn from an orifice 40. Referring to Figure 5 specifically, in some cases, blood 62 collected with exhaust plug 42 may be expelled onto a test strip or other object for testing purposes when a finger 80 presses against membrane 44 to increase pressure in lumen 52. This process will be described in more detail below. To facilitate expulsion of blood, the distal lumen opening 58 can be configured large enough that an adult middle finger can apply sufficient pressure to expel a drop of blood 84 from fluid chamber 68. , the distal lumen opening 58 has an inner perimeter greater than or equal to approximately 0.3 mm, which when the distal lumen opening 58 is a circular opening, corresponds to a diameter of approximately 0.1 mm. Thus, in some configurations, the distal opening of lumen 58 has an inner perimeter between approximately 0.3 mm and approximately 2.0 mm. In some configurations, the distal opening of lumen 58 is approximately circular and has a diameter between approximately 0.1 mm and approximately 0.6 mm. In other embodiments, the distal opening of lumen 58 is non-circular.
    [026] Reference will now be made to Figure 4. Figure 4 illustrates a cross-sectional view of an exhaust plug 42 after being removed from an orifice 40. Similar to the exhaust plug 42 illustrated in Figure 3, a membrane 44 is coupled to an upper portion of the body 50 of the exhaust plug 42. In some embodiments, the membrane 44 is coupled to an inner surface of the inner lumen 52 of the body. Such coupling can be mechanical or chemical, for example, using an adhesive or other fastener 64. In other embodiments, the membrane 44 is coupled to an upper surface of the body 50 rather than being disposed in the lumen 52.
    [027] In some configurations, the membrane 44 is inclined to bulge proximally, as shown in figure 3. The bulging portion can act as a button that when pressed down sufficiently 82 can cause one or more drops of blood. 84 fall from the fluid chamber 68. As shown in Figure 4, the domed nature of the membrane 44 positions the membrane 44 in a pre-compressed position 76 until it is biased to a depressed position 74 by downward force 82 of a finger 80. This downward force 82 results in a decrease in the volume of fluid chamber 68 that is approximately equal to the displacement volume 78 between precompressed 76 and compressed 74 positions of membrane 44, as shown. As the volume of fluid chamber 68 decreases, the pressure in fluid chamber 68 increases. In some cases, this increase in pressure in fluid chamber 68 causes one or more drops of blood 84 to be expelled downward 82 and out of fluid chamber 68, as shown. After the blood drop 84 is expelled and the pressure of the finger 80 is released, the membrane 44 is allowed to return to its pre-compressed position, protruding 76. As the membrane 44 moves upward, the volume of the fluid chamber 68 expands by decreasing the internal pressure of fluid chamber 68, drawing air therein. This fresh air can move upward as the heavier blood 62 sinks towards the distal opening of lumen 58. At this point, the membrane 44 of the exhaust plug 42 can be compressed again to expel another drop of blood 84. In this way, as described in some embodiments, the exhaust plug 42 can be selectively activated to release blood drops 84 on command, as shown in figures 4 and 5.
    [028] Figure 5 represents the action of selectively releasing blood drops 84 from the exhaust plug 42 onto a surface. As shown, a technician can hold the exhaust plug 42 with one or more fingers 80. Thereafter by sufficiently tamping the membrane 44, the technician can expel one or more drops of blood 84 from the exhaust plug 42. In some embodiments, the displacement volume 78 between the precompressed position 76 and the compressed position 74 may be designed to cause the expulsion of two or more drops of blood 84 or a single large drop of blood 84. In some embodiments, the membrane 44 is configured so that it is capable of being only partially compressed so that a smaller drop of blood 84 is expelled than if the membrane 44 were fully compressed.
    [029] As shown in Figure 5, in some embodiments, the body 50 of the exhaust plug 42 is molded and sized so that it can be held between two or more fingers 80. Therefore, in some configurations, the length 70 of the body 50 is approximately equal to or greater than the width of the average human thumb. Body 50 may also be wide enough to be adequately held in two or more fingers 80. As further shown, in some embodiments, body 50 includes an upper disc 92 or other similar structure from which membrane 44 bulges out. This upper disc 92 can be used to pry the exhaust plug 42 out of an orifice 40 and/or to prevent a finger 80 that is gripping the side of the body 50 accidentally compressing the membrane 44.
    [030] Figure 6 depicts an exhaust plug 42 having a membrane 102 disposed in the lumen 52. In this position, the membrane 102 divides the lumen 52 into an air chamber 114 proximal to the membrane 102 and a fluid chamber 68 distal to the membrane 102. Similar to the embodiments of Figures 4 and 5, the exhaust plug 42 of Figures 6 and 7 may be capable of expelling one or more drops of blood 84 when a finger 80 is pressed downward 82 against the proximal lumen opening 72 of the body 50. However, unlike the modalities of figures 4 and 5, the exhaust plug 42 of figures 6 and 7 expels blood 62 as air is forced from air chamber 114 through membrane 102 into the chamber. of fluid 58 rather than in response to the movement of the membrane 102. This increase in air increases the internal pressure within the fluid chamber, which can cause one or more drops of blood to be expelled out of the distal opening of 58 lumen.
    [031] In some embodiments, to more effectively expel a drop of blood 84, finger 80 covers the proximal opening of lumen 72 to seal that opening. Once sealed, or substantially sealed, finger 80 can be pressed deeper (distally) into lumen 52 to compress air 64 in air chamber 114. In some configurations, the proximal lumen opening 72 is rounded, to provide more comfort for the technician and facilitate sealing of this opening. Similarly, in other configurations, the proximal lumen opening 72 includes a pad, such as an elastomeric material disposed therein. In some embodiments, this pillow can act as a compressible element, as will be described below.
    [032] As shown in Figures 6 and 7, as a finger 80 is pressed downward 82 against the proximal opening of lumen 72, air 64 can enter the air chamber 114 through flow paths 108 between the finger 80 and the body 50 of the exhaust plug 42. As the finger 80 presses farther against the inner surface 116 of the proximal lumen opening 72 it can at least partially seal the proximal lumen opening 72 and compress the air 64 in the chamber. ar 114. The distance 106 between the proximal lumen opening 72 and the membrane 102 may be far enough away that the middle adult finger 80 does not contact the membrane 102 as the finger 80 is pressed against the proximal lumen opening 72. Compressing air in the air chamber 114 can force air 64 through the membrane 102 into the fluid chamber 68. As that air is introduced into the fluid chamber 68 the pressure in that chamber 68 increases and can cause one or more droplets. of blood 84 is expelled out of the a distal opening of lumen 58. Therefore, in some embodiments, the exhaust plug 42 can be selectively activated to release blood drops 84 on command, similar to the exhaust plug 42 shown in Figure 5.
    [033] Figures 8 and 9 illustrate variations of the exhaust plug 42 shown in Figures 6 and 7. As shown, this exhaust plug 42 includes a compressible portion 122 that forms part of the air chamber barrier 114. This compressible portion 122 may include one or more accordion-like elements 124 that are compressed when a downward (distal) force 82 is applied thereto. Other types of compressible elements can include a spring, an elastomer, or other similar element. A compressible portion 122 can be made of the same material as the rest of the body 50 or it can be made of a separate material, for example, as an elastomeric material such as rubber, silicone rubber, etc.
    [034] In some embodiments, the exhaust plug 42 is activated similarly to that of Figures 6 and 7, as a finger 80 is pressed against the proximal opening of lumen 72. The finger 80 can seal or substantially seal the air chamber 114 and compressing the compressible portion 122 of the tube 114. The compressible portion 122 may allow for further pressurization of the tube 114, causing more air 64 to be forced through the membrane 102 as it compresses the height of the tube 114 from from an uncompressed height 126 to a compressed height 128. The decrease in height further pressurizes the air chamber 114, providing additional force to force air 64 through the membrane 102 and expel one or more drops of blood 84 out of the distal opening of 58 lumen, as described above.
    [035] From the above, it will be seen that the modalities of an exhaust plug 42 described here can be used to bleed an extravascular system 20 as well as collect a blood sample and subsequently dispense the blood sample. Thus, these modalities of an exhaust plug 42 reduce the number of steps and devices needed to perform these procedures, which can reduce the time and cost of these procedures.
    [036] The present invention can be incorporated into other specific forms without departing from its structures, methods and/or other essential features as broadly described herein and claimed below. The modalities described are to be considered in all respects only as illustrative and not restrictive. The scope of the invention is therefore indicated by the appended claims rather than the above description. All changes that are comprised in the meaning and equivalence range of the claims must fall within their scope.
    权利要求:
    Claims (14)
    [0001]
    1. An exhaust plug (42), comprising: a body (50) having a distal end (48), a proximal end (46), and a lumen (52) extending through the distal (52) and proximal (46) ends a membrane (44, 102) being hydrophobic and air permeable; CHARACTERIZED by the fact that the membrane (44, 102) is disposed across the lumen (52), a fluid chamber (68) is formed in the distal lumen (52) of the membrane (44, 102), a distal lumen opening (58) is shaped and sized to retain blood in the lumen (52) until the internal pressure of the lumen (52) increases in response to a finger (80) pressing against a proximal lumen opening (72).
    [0002]
    2. Exhaust plug (42) according to claim 1, CHARACTERIZED by the fact that the membrane (44) is coupled to a proximal lumen opening (72) such that a finger (80) pressing against the opening (72) proximal lumen press against the membrane (44).
    [0003]
    3. Exhaust plug (42) according to claim 2, CHARACTERIZED by the fact that the membrane (44) is inclined to bulge proximally.
    [0004]
    4. Exhaust plug (42) according to claim 3, CHARACTERIZED by the fact that the displacement volume caused when the membrane (44) is distally compressed is at least 0.05 mL.
    [0005]
    5. Exhaust plug (42) according to claim 1, CHARACTERIZED by the fact that the membrane (102) is disposed in the lumen, the membrane (102) dividing the lumen (52) into an air chamber (64) proximal to the membrane (102) and a fluid chamber (68) distal to the membrane.
    [0006]
    6. Exhaust plug (42) according to claim 5, CHARACTERIZED by the fact that the body (50) includes a compressible portion (122) at its proximal end (46), the compressible portion (122) forming a portion of a surface of the air chamber (64).
    [0007]
    7. Exhaust plug (42) according to claim 1, CHARACTERIZED by the fact that the distal lumen opening (58) has an internal perimeter equal to or less than 2.0 mm.
    [0008]
    8. Exhaust plug (42) according to claim 1, CHARACTERIZED by the fact that the distal lumen opening (52) is substantially circular and has a diameter (60) between approximately 0.1 mm and approximately 0.6 mm.
    [0009]
    9. Exhaust plug, according to claim 1, CHARACTERIZED by the fact that the distal lumen opening is substantially circular and has a diameter (60) between approximately 0.2 mm and approximately 0.3 mm.
    [0010]
    10. Exhaust plug (42) according to claim 1, CHARACTERIZED by the fact that the fluid chamber (68) has a volume of at least 0.1 ml.
    [0011]
    11. Method for collecting blood samples, the method being CHARACTERIZED by the fact that it comprises: providing an exhaust plug (42) in an orifice of an intravenous infusion therapy system (20), the exhaust plug (42) having a body (50) with a lumen (52) therethrough and a membrane (44, 102) disposed across the lumen (52), the membrane (44, 102) being hydrophobic and air permeable, a distal lumen opening ( 58) of the exhaust plug (42) being shaped and sized to retain blood in the lumen (52) until the internal pressure of the lumen (52) increases in response to a finger (80) pressing against a proximal lumen opening (72) ; exhausting air from the intravenous infusion therapy system and at least substantially filling the exhaust plug with blood; removing the exhaust plug (42) from the intravenous infusion therapy system; and expelling a volume of blood from the exhaust plug (42) by pressing a finger (80) distally into the proximal lumen opening (52) of the exhaust plug (42).
    [0012]
    12. Method according to claim 11, CHARACTERIZED by the fact that the membrane (44) is coupled to the proximal opening (72) of the lumen and is inclined to bulge proximally, and in which to expel a volume of blood (84 ) includes compressing the membrane (44) distally.
    [0013]
    13. Method according to claim 11, CHARACTERIZED by the fact that the air-permeable membrane (102) divides the lumen (52) into an air chamber (64) proximal to the membrane (102) and a fluid chamber ( 68) distal to the membrane (102), and wherein expelling a volume of blood (84) includes increasing the internal pressure of the air chamber (64).
    [0014]
    14. The method of claim 13, CHARACTERIZED in that the body (50) includes a compressible proximal portion (122), and wherein expelling a volume of blood includes compressing the compressible proximal portion (122) of the body ( 50).
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    法律状态:
    2018-12-26| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|
    2019-12-10| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|
    2021-05-25| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|
    2021-06-29| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 19/07/2011, OBSERVADAS AS CONDICOES LEGAIS. |
    优先权:
    申请号 | 申请日 | 专利标题
    US36538810P| true| 2010-07-19|2010-07-19|
    US61/365,388|2010-07-19|
    US13/185,139|2011-07-18|
    US13/185,139|US9549701B2|2010-07-19|2011-07-18|Device and method for collecting a blood sample|
    PCT/US2011/044501|WO2012012400A1|2010-07-19|2011-07-19|A device and method for collecting a blood sample|
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