Abstract:
A blood sampling device for allowing a fluid pressure measurement and a fluid sample to be taken from a patient, having an inlet port configured to receive blood from the patient, an outlet port configured to be coupled to a monitoring channel having an infusion fluid, a sampling port configured for extraction of blood from the patient, a sampling channel configured to self-flush, after extraction, the blood with the infusion fluid, and an auxiliary channel for self-flushing the sampling channel.

Description:
FIELD OF THE INVENTION  
       [0001]     The invention relates generally to blood sampling devices, such as is commonly used at a blood sampling site, and more particularly to self flushing luer activated blood sampling devices.  
       DESCRIPTION OF THE RELATED ART  
       [0002]     Blood sampling systems, such as Venous Arterial blood Management Protection (VAMP) systems, provide a safe and convenient method for withdrawing blood samples from a patient. Conventional VAMP systems typically consist of a fluid (e.g. pressure monitoring) line with a reservoir, a shutoff valve and a sampling site. The proximal end of the fluid line is coupled to an intravenous (IV) needle that is inserted into a patient&#39;s vein or artery. The distal end of the fluid line is coupled to pressure monitoring lines or continuous IV infusion or saline lines.  
         [0003]     In the quiescent state, the shutoff valve is open allowing the solution from the IV bag to be gravity fed through the fluid line and the IV needle into the patient. To obtain a blood sample, the reservoir is slowly moved to an open position allowing the reservoir to fill with IV solution. The shutoff valve, located downstream from the reservoir, is then placed in a closed position preventing fluid from flowing through the valve. A needle of a syringe is inserted into the sampling site and blood is extracted therefrom. Some blood sampling systems utilize a luer configuration to couple the syringe or blood extractor to the sampling site. After the blood has been drawn, the needle is removed from the sampling site and the reservoir is slowly returned to the closed position, thereby reestablishing the connection between the patient&#39;s circulatory system and the IV infusion or saline line.  
         [0004]     Generally, a VAMP system uses a conventional stopcock to isolate the reservoir from the sampling site while allowing for the patient&#39;s blood to be extracted through the proximal end of the fluid line. This allows blood sampling without degrading the quality of the pressure waveform when monitoring patient blood pressure, and still maintains a closed blood sampling system.  
         [0005]     While the VAMP system facilitates blood sampling without the need to puncture another needle or cannula into the patient, application of this technology has an undesirable consequence. For example, residual blood left in sampling sites can become a significant source of contamination and infection. Typically, the exterior surface of the sampling site is swabbed clean of any residual blood. However, the interior of the sampling sites cannot be swabbed clean. Furthermore, sampling sites with luer access, such as the CLAVE® Connector from ICU Medical Inc., do not have a flush exterior surface that can be swabbed clean. As a result, residual blood inside the luer can be a source of contamination and infection or can dry up and clog the luer access.  
         [0006]     With an increasing demand for improved blood sampling systems, there remains a continuing need in the art for a blood sampling system that self-flushes once the blood sampling procedure is completed so as to prevent contamination, infection and blood clotting. It is to such improvements that the present invention is directed.  
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0007]     Many of the advantages, object and features of the invention will become readily appreciated by reference to the following detailed description when considered in conjunction with the accompanying drawings in which like reference numerals description like parts throughout the figures, and wherein:  
         [0008]      FIG. 1  is a perspective view of a Venous Arterial blood Management Protection (VAMP) system.  
         [0009]      FIGS. 2A and 2B  illustrate cross-sectional views of a blood sampling device with a paddle in accordance with an embodiment of the present invention.  
         [0010]      FIGS. 3A and 3B  illustrate cross-sectional views of a blood sampling device with a ball valve in accordance with an embodiment of the present invention.  
         [0011]      FIGS. 4A and 4B  illustrate cross-sectional views of a blood sampling device with a ball cock in accordance with an embodiment of the present invention.  
         [0012]      FIGS. 5A and 5B  illustrate cross-sectional views of a blood sampling device with a paddle in accordance with an embodiment of the present invention.  
         [0013]      FIGS. 6A and 6B  illustrate cross-sectional views of a blood sampling device with a slide in accordance with an embodiment of the present invention.  
         [0014]      FIGS. 7A and 7B  illustrate cross-sectional views of a blood sampling device with a ball cock positioned in the monitoring channel, in accordance with an embodiment of the present invention. 
     
    
     SUMMARY OF THE INVENTION  
       [0015]     A blood sampling device configured to prevent contamination, infection and blood clotting. The blood sampling device allows fluid pressure measurement and blood sampling to be taken from a patient. The blood sampling device has an inlet port configured to receive blood from the patient, an outlet port configured to be coupled to a monitoring channel having an infusion fluid, a sampling port configured for extraction of blood from the patient, a sampling channel configured to self-flush, after extraction, the blood with the infusion fluid, and an auxiliary channel for self-flushing the sampling channel.  
         [0016]     In one embodiment, the blood sampling device includes a rotatable paddle coupled to the sampling channel and orients the sampling channel to align with the auxiliary channel for self-flushing. In another embodiment, the blood sampling device has a ball valve configured to selectively allow the blood or the infusion fluid to flow through the sampling channel or the auxiliary channel. In one embodiment, the sampling port may be configured to allow a needle to draw the blood while blocking access to the auxiliary channel. In another embodiment, the blood sampling device has a slide with an opening that selectively allows the flow of blood through the sampling channel or the flow of the infusion fluid through the auxiliary channel. In one embodiment, the blood sampling device has a stop cock that can selectively allow fluid to pass through at least one of the sampling channel, the auxiliary channel, or the monitoring channel. The stop cock may be configured to stop the flow of infusion fluid when the blood is being extracted.  
         [0017]     The different embodiments of the blood sampling devices described herein advantageously do not require flushing with a physiological saline solution after a blood sample has been drawn. The blood sampling devices are “self flushing” after blood sampling, which provides a convenient benefit to the healthcare provider, and greater safety to the patient, by eliminating the potential for embolization of clotted blood if the sample site is not flushed properly.  
       DETAILED DESCRIPTION  
       [0018]     Methods and systems that implement the embodiments of the various features of the invention will now be described with reference to the drawings. The drawings and the associated descriptions are provided to illustrate embodiments of the invention and not to limit the scope of the invention. Reference in the specification to “one embodiment” or “an embodiment” is intended to indicate that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least an embodiment of the invention. The appearances of the phrase “in one embodiment” or “an embodiment” in various places in the specification are not necessarily all referring to the same embodiment. Throughout the drawings, reference numbers are re-used to indicate correspondence between referenced elements. In addition, the first digit of each reference number indicates the figure in which the element first appears.  
         [0019]      FIG. 1  is a perspective of a Venous Arterial blood Management Protection (VAMP) system  100 . The VAMP system  100  may include a fluid line  105  having a proximal end  110  and a distal end  115  relative to the patient. The VAMP system  100  may also include a blood sampling device  120 , a valve  125  and a reservoir  130 . The proximal end  110  of the fluid line  105  is coupled to an intravenous (IV) needle that is inserted into a patient&#39;s vein or artery. The distal end  115  of the fluid line  105  is coupled to pressure monitoring lines and/or continuous IV infusion (saline) line.  
         [0020]     To draw a sample of blood from the patient, the valve  125  is moved to a closed position, the reservoir  130  is moved to a closed position, and a syringe is attached to the blood sampling device  120  to draw blood from the patient. After the sample is drawn from the patient, the syringe is detached from the blood sampling device  120 , the reservoir  130  is moved to an open position, and the valve  125  is moved to an open position.  
         [0021]      FIGS. 2A and 2B  are cross-sectional views of a blood sampling device  200  in accordance with an embodiment of the present invention. The blood sampling device  200  may include a diaphragm  205  (e.g., a septum), a luer  210 , a sampling channel  215 , a monitoring or IV channel  220 , an auxiliary channel  225 , a passageway  235  and a paddle  230 . The luer  210  can be configured to receive or attach to a cannula, which is attached to a syringe (not shown in the Figure). The sampling channel  215  can be used for blood sampling, and the monitoring channel  220  can be used for monitoring the patient&#39;s blood pressure. The auxiliary channel  225  allows the blood sampling device  200  to “self flush” after blood sampling is completed.  
         [0022]     The paddle  230  can be hinged to the blood sampling device  200  to allow for rotational movement about a central axis. The paddle is coupled to the passageway  235 , such that when the paddle  230  is rotated, the passageway  235  rotates the axis as well. The passageway  235  provides a path for blood to flow from the patient&#39;s circulatory system through the sampling channel  215  and into the syringe.  
         [0023]     The blood sampling device  200  can operate in a blood sampling mode ( FIG. 2A ) and a pressure monitoring mode ( FIG. 2B ). To draw a sample of blood from the patient, the valve  125  (shown in  FIG. 1 ) is closed to stop the flow of IV infusion fluid to the patient. Next, the paddle  230  is rotated to a first position, shown in  FIG. 2A , that allows blood to flow through the sampling channel  215 , the passageway  235  and into the syringe. After the sample is drawn from the patient, the valve  125  is opened and the paddle  230  can be rotated to a second position, shown in  FIG. 2B , that allows the IV infusion fluid to flow through the auxiliary channel  225  and the passageway  235 . Hence, this embodiment provides a “self-flushing” mechanism that clears blood residue after blood sampling.  
         [0024]      FIGS. 3A and 3B  are cross-sectional views of a blood sampling device  300  in accordance with an embodiment of the invention. The blood sampling device  300  may include the diaphragm  205 , the luer  210 , the sampling channel  215 , the monitoring channel  220 , the auxiliary channel  225  and a ball valve  305 . The ball valve  305  has a passageway  310  to allow fluid to pass therethrough.  
         [0025]     The blood sampling device  300  can operate in a blood sampling mode ( FIG. 3A ) and a pressure monitoring mode ( FIG. 3B ). To draw a sample of blood from the patient, the valve  125  (shown in  FIG. 1 ) is closed to stop the flow of IV infusion fluid to the patient. Once a sample is drawn from the patient, the valve  125  is opened to allow the flow of IV infusion fluid to the patient. In the blood sampling mode, the ball valve  305  is rotated to a first position that allows blood to flow through the sampling channel  215 , the passageway  310  and into the syringe. In the pressure monitoring mode, the ball valve  305  is rotated to a second position that blocks the flow of fluid through the sampling channel  215  and allows the flow of IV infusion fluid through the auxiliary channel  225  and the passageway  310 . Hence, this embodiment provides a “self-flushing” mechanism that clears blood residue after blood sampling.  
         [0026]      FIGS. 4A and 4B  are cross-sectional views of a blood sampling device  400  in accordance with an embodiment of the invention. The blood sampling device  400  may include the diaphragm  205 , the luer  210 , the sampling channel  215 , the monitoring channel  220 , the auxiliary channel  225  and a stop cock  405 . The stop cock  405  has a T-shaped passageway  410  that can selectively allow fluid to pass therethrough to the sampling channel  215 , the auxiliary channel  225 , or the monitoring channel  220 .  
         [0027]     The blood sampling device  400  can operate in a blood sampling mode ( FIG. 4A ) and a pressure monitoring mode ( FIG. 4B ). To draw a sample of blood from the patient, the valve  125  (shown in  FIG. 1 ) is closed to stop the flow of IV infusion fluid to the patient. Once a sample is drawn from the patient, the valve  125  is opened to allow the flow of IV infusion fluid to the patient. In the blood sampling mode, the stop cock  405  is positioned to selectively allow blood flow through the passageway  410 , the sampling channel  215  and a segment of the auxiliary channel  225 . In the pressure monitoring mode, the stop cock  405  is positioned to block the flow of fluid through the sampling channel  215 , while selectively allowing the flow of the fluid through the sampling channel  215 , the auxiliary channel  225 , and the monitoring channel  220 . Hence, this embodiment provides a “self-flushing” mechanism that clears blood residue after blood sampling.  
         [0028]      FIGS. 5A and 5B  are cross-sectional views of a blood sampling device  500  in accordance with an embodiment of the invention. The blood sampling device  500  may include the diaphragm  205 , the luer  210 , the sampling channel  215 , the monitoring channel  220  and the auxiliary channel  225 .  
         [0029]     The blood sampling device  500  can operate in a blood sampling mode ( FIG. 5A ) and a pressure monitoring mode ( FIG. 5B ). To draw a sample of blood from the patient, the valve  125  (shown in  FIG. 1 ) is closed to stop the flow of IV infusion fluid to the patient. Next, a syringe tip  505  is inserted through the diaphragm  205 . When inserted, the syringe tip  505  allows blood to flow through the sampling channel  215 , while blocking the flow of fluid through the auxiliary channel  225 . After the blood sample is drawn from the patient, the syringe tip  505  is removed and the valve  125  is reopened. When the syringe tip  505  is removed, as shown in  FIG. 5B , the IV infusion fluid can flow from the auxiliary channel  225  to the sampling channel  215 , or vica versa. Hence, this embodiment provides a “self-flushing” mechanism that clears blood residue after blood sampling.  
         [0030]      FIGS. 6A and 6B  are cross-sectional views of a blood sampling device  600  in accordance with an embodiment of the invention. The blood sampling device  600  may include the diaphragm  205 , the luer  210 , the sampling channel  215 , the monitoring channel  220 , the auxiliary channel  225  and a slide  605 . The slide  605  has a passageway  610  to allow fluid to pass therethrough.  
         [0031]     The blood sampling device  600  can operate in a blood sampling mode ( FIG. 6A ) and a pressure monitoring mode ( FIG. 6B ). To draw a sample of blood from the patient, the valve  125  (shown in  FIG. 1 ) is closed to stop the flow of IV infusion fluid to the patient. Once a sample is drawn from the patient, the valve  125  is opened to allow the flow of IV infusion fluid to the patient. In the blood sampling mode (FIG.  6 A), the slide  605  is positioned to selectively allow blood flow through the passageway  610  and the sampling channel  215 , while closing one end of the auxiliary channel  225 . In the pressure monitoring mode ( FIG. 6B ), the slide  605  is positioned to block the flow of fluid through the sampling channel  215  and allows the flow of the IV infusion fluid through the auxiliary channel  225  and the passageway  610 . Hence, this embodiment provides a “self-flushing” mechanism that clears blood residue after blood sampling.  
         [0032]     The different embodiments of the blood sampling devices described herein advantageously do not require flushing with a physiological saline solution after a blood sample has been drawn. The blood sampling devices are “self flushing” after blood sampling, which provides a convenient benefit to the healthcare provider, and greater safety to the patient, by eliminating the potential for embolization of clotted blood if the sample site is not flushed properly. In one embodiment, the blood sampling devices may eliminate the need for the valve  125 . In another embodiment, the fidelity of the pressure wave form can be enhanced by isolating the sampling channel  215  septum from the monitoring channel  220 .  
         [0033]      FIGS. 7A and 7B  are cross-sectional views of a blood sampling device  700  in accordance with an embodiment of the invention. The blood sampling device  700  may include the diaphragm  205 , the luer  210 , the sampling channel  215 , the monitoring channel  220 , the auxiliary channel  225  and a stop cock  705 . The stop cock  705  has a T-shaped passageway  710  that can selectively allow fluid to pass therethrough to the sampling channel  215 , the auxiliary channel  225 , or the monitoring channel  220 . The stop cock  705  is coupled to the monitoring channel  220  to control the flow of the IV infusion fluid through the monitoring channel  220 , while allowing for the self-flushing capability after blood sampling.  
         [0034]     The blood sampling device  700  can operate in a blood sampling mode ( FIG. 7A ) and a pressure monitoring mode ( FIG. 7B ). To draw a sample of blood from the patient, the stop cock  705  (shown in  FIG. 1 ) is rotated to a position that stops the flow of IV infusion fluid to the patient. Once a sample is drawn from the patient, the stop cock  705  is rotated back to allow the flow of IV infusion fluid to the patient while self-flushing the passageway  710 , the sampling channel  215 , and the auxiliary channel  225 .  
         [0035]     In the blood sampling mode, the stop cock  705  is positioned to selectively allow blood flow through the passageway  710 , the sampling channel  215  and a segment of the auxiliary channel  225 . In the pressure monitoring mode, the stop cock  705  is positioned to allow the flow of fluid through the sampling channel  215 , the auxiliary channel  225 , and the monitoring channel  220 . Hence, this embodiment provides a “self-flushing” mechanism that clears blood residue after blood sampling, while eliminating the need for a valve  125  upstream in the monitoring channel  220  to stop the flow of IV infusion fluid.