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    • 专利摘要:
    SYSTEM AND METHOD FOR CONTROLLED RELEASE OF A MEDICINAL FLUID AND VALVE ASSEMBLY TO CONTROL THE TRANSMISSION OF THE REFERENCE FLUID A system for controlled release of medicinal fluid to a patient including an inlet duct connected to a source of a medical fluid and an outlet duct connected to the patient. The inlet and outlet ducts are interconnected by a set of multi-stage control valves and a pair of syringes. The set of control valves is switched between a first state in which the inlet conduit communicates with a first syringe to transmit fluid from the source of the first syringe, a second state in which the first syringe communicates with the second syringe and is isolated of the inlet and outlet duct for the transmission of fluid from the first syringe to the second syringe, and a third state where the second syringe communicates with the outlet and is isolated from the inlet and the first syringe for the transmission of fluid from the second syringe to the patient through the exit.
    公开号:BR112013024475B1
    申请号:R112013024475-5
    申请日:2012-03-26
    公开日:2021-03-02
    发明作者:Kimberley Levy；Frank Levy
    申请人:Kimberley Levy；Frank Levy；
    IPC主号:
    专利说明:

    [0001] The application claims the benefits of US Patent Application No. 13 / 065,621 filed on March 25, 2011.
    [0002] This invention relates to a system to safely release a controlled volume of a medical fluid to a patient and, more particularly to a system to release a controlled flow of carbon dioxide (CO2) or other contrast fluid in order to obtain X-ray images.
    [0003] Various types of medical equipment have been used to deliver controlled volumes of liquid and gaseous substances to patients. A field that involves the administration of these fluids is radiology, where a small amount of carbon dioxide gas or alternative contrast medium is released to the patient's vascular system in order to replace the patient's blood and obtain improved images of the vascular system. . Traditionally, this has required that CO2 or another medium first be released from a pressurized cylinder to a syringe. The filled syringe is then disconnected from the cylinder and reconnected to a catheter connected to the patient. If additional CO2 is needed, the syringe must be disconnected from the catheter and reconnected to the cylinder for refilling. Not only is this procedure tedious and time consuming, it presents a serious risk of introducing air into the CO2 or contrast fluid and at each point of disconnection. Injection like air into the patient's blood vessels can be extremely dangerous and even fatal.
    [0004] Recinella et al., US Patent No. 6,315,762 discloses a closed delivery system where a pouch containing up to 2,000 ml of carbon dioxide or another contrast medium is selectively interconnected by scissors through the passage chamber. a syringe or catheter connected to the patient. Although this system reduces the introduction of air into the administered fluid caused by the disconnection and reconnection of individual components, it will still exhibit a number of deficiencies. For example, potential dangerous volumes of air are enabled to be trapped with the bag. This usually requires the bag to be manipulated and released multiple times before being connected to the passing scissors and ultimately to the catheter. Furthermore, this system does not feature reliable and safe fail-safe operation. If the scissor valve is incorrectly operated to inadvertently connect the filled carbon dioxide bag or other carbon dioxide source directly to the client's catheter, a potentially lethal and dangerous volume of CO2 may suddenly be released into the patient's vascular system . It will be considered a medical criticism to avoid said CO2 and to flow into the blood vessels.
    [0005] It is thus an object of the invention to provide a system to safely and reliably deliver a controlled dosage of a fluid to a medical patient.
    [0006] It is yet another objective of this invention, to provide a fluid (i.e. liquid or gas) delivery system that is particularly effective for use in the administration of CO2 or other contrast medium in a controlled manner to a vascular system of a patient to provide optimized contrast for X-ray imaging.
    [0007] It is still an objective of this invention to provide a fluid delivery system and particularly a CO2 contrast medium that prevents potentially dangerous amounts of air from entering the fluid and thus being administered to the patient.
    [0008] It is still an objective of this invention to provide a fluid delivery system that accidentally prevents flow to the patient's vascular system with carbon dioxide or other gases or liquids administered under positive pressure.
    [0009] It is yet another objective of this invention to provide a fluid delivery system exhibiting a fail-safe and safe operation, which allows only reliable and safe controlled dosages of a medical fluid to be administered to a patient.
    [00010] It is still an objective of this invention to provide a fluid delivery system that can be used safely and effectively with virtually any source of carbon dioxide or other medical fluid regardless of the pressure or environment under which that fluid will be kept,
    [00011] It is still an objective of this invention to provide a fluid flow system that prevents an administered medicinal fluid from flowing in an unintended direction through the system.
    [00012] This invention is the result of a realization that a fail-safe system to safely release controlled quantities of a medical fluid such as CO2 or other contrast medium to a patient can be accompanied by the use of a multi-part valve that releases the fluid in precise quantities controlled sequentially through a series of syringes so that it is impossible to directly connect the fluid source to the patient. At the same time, the delivery system does not have to be disconnected and reconnected during the administration of the medical fluid. This greatly reduces the intrusion of air into the system and the fluid being administered.
    [00013] The invention is characterized by a system for the controlled release of a medicinal fluid from a source of said fluid to a patient. The system includes an inlet conduit that is communicably connected to a source of medicinal fluid and an outlet conduit that is connected in a communicable manner to the patient. The first and second syringes are intermediate to the inlet and outlet ducts. A set of control valves interconnects the inlet and outlet ducts as well as the intermediate first and second syringes. The set of control valves alternates between the first, second and third states. In the first state, the inlet communicates with the first syringe for the transmission of fluid from the source to the first syringe. In the second state, the first syringe communicates with the second syringe and is isolated from the inlet and outlet conduits for the transmission of fluid from the first syringe to the second syringe. In the third state, the second syringe communicates with the outlet conduit and is isolated from the inlet conduit and the first syringe. This allows the fluid to be transmitted from the second syringe to the patient through the outlet conduit.
    [00014] In one configuration, the valve assembly includes a valve body having aligned inlet and outlet ports that are communicably connected to the inlet and outlet ducts respectively. The valve body also includes a pair of first and second intermediate ports that extend transversely axially to the inlet and outlet ports and transversely to each other. A stopcock is pivotally mounted within the valve body and includes an angled channel having a pair of communicably interconnected channel segments that extend axially at an acute angle that is generally equivalent to the angle formed between each to of adjacent non-aligned ports on the valve body so that the stopcock will be rotated to align the channel segments with a selected for of adjacent non-aligned ports to allow communication between these ports. Each of the intermediate ports is connected to a respective syringe. The stopcock is selectively adjusted between the first, second and third positions. In the first position, the segments of the channels interconnect in a communicable way to the entrance door and to the first of one of the intermediate doors.
    [00015] The fluid introduced through the part of the inlet duct is then transmitted through the inlet port and the channel from the stopcock to the first intermediate port. The port directs the fluid to a first syringe connected to it. In the second position of the valve, the stopcock aligns with the segments of the channels with the first and second intermediate ports respectively. This isolates the fluid in the first syringe from both the inlet and outlet ducts. The first syringe is operated to direct the fluid through the first intermediate port, the stopcock channel and the second intermediate port in a second syringe joined to the second intermediate port in the third valve position, the stopcock being rotated to align the channel segments with the second intermediate port and the output port respectively. This isolates the fluid in the second syringe from the fluid source of the inlet port and the first intermediate port. The second syringe is then operated to direct the fluid through the second intermediate port, the stopcock channel and the outlet port to the outlet conduit. The outlet duct directs this fluid to the patient.
    [00016] The respective longitudinal axes of the input and output ports are aligned. The first and second intermediate doors may include respectively longitudinal axes that form an angle of substantially 60 degrees with one another. The first intermediate door may form an axial angle of substantially 60 degrees with the longitudinal axis of the entrance door and, similarly, the axis of the second intermediate door may form an angle of substantially 60 degrees with the longitudinal axis of the exit door.
    [00017] The angular channel formed in the stopcock preferably characterizes the segments of the channels with respective longitudinal axes that form an angle of substantially 60 degrees. As used here, "substantially 60 degrees" means that the angles are precisely or approximately 60 degrees so that the tap channel segments are communicable and selectively interacted with a respective adjacent non-aligned door stop at each of the three positions of the valves. Alternative angles may be highlighted when the inlet and outlet ducts are not aligned. A lever is connected to the valve body to adjust the stopcock between alternative valve positions.
    [00018] The inlet conduit may include a component to interconnect in a sealed manner to a source of medicinal fluid. The component may include a one-way valve to limit fluid flow to a single direction from the fluid source to the valve assembly to prevent flow in the opposite direction. The inlet conduit may include metal piping. A second one-way valve can be mounted inside the valve body inlet port to restrict the flow of fluid from the valve body to the inlet conduit.
    [00019] The valve set may also include a one-way valve mounted on the outlet port to restrict fluid flow to a single direction from the outlet port to the outlet conduit and to prevent fluid flow in the opposite direction. A second metal section of the pipeline is being formed in the outlet section.
    [00020] The outlet duct may lead to a lower valve for purging fluid or blood and / or for the administration of an additive fluid to the controlled fluid. The outlet conduit can be connected in a communicable way to a patient's catheter. An additional one-way valve can be driven through the lower valve to restrict fluid flow through the lower valve to a single direction from the outlet to the patient's catheter.
    [00021] The outlet conduit may alternatively be connected to a lower component having a one-way valve to direct the flow of fluid from the outlet conduit through the component to the patient. The component may include a port that allows fluid to be purged or released from the catheter. The port can also be used to deliver medication through the patient's component and catheter. The lower component can be connected to a medication or fluid delivery syringe through a conduit that is connected to the lower component. The respective Luer ™ components can be used to interconnect the inlet and outlet ducts to the control valve. A Luer ™ component can also be used to connect the lower valve or the catheter component.
    [00022] The system of this invention may alternatively indicate the sequential, or multiple-stage, release of a medical fluid from a source to a patient through a pair of directional or multi-directional valves. A first said valve is operated to release fluid from the source to a first syringe or to release fluid from a first syringe at the inlet of a second valve. The second valve is then operated to selectively deliver fluid from the first syringe through the second valve to a second syringe. Alternatively, the second valve can be operated to release fluid from the second syringe to the lower or patient catheter. A critical feature of this invention is that an accurate volume or dosage of CO2 or other medical liquid / gas will be released sequentially in three distinct stages from the source to the patient. At each stage, the source, which is typically under pressure, remains completely isolated from the patient so that the fluid is administered much more safely than the previous systems.
    [00023] This invention further indicates a process for releasing medicinal fluid from a source of said fluid in controlled doses. The process involves the provision of inlet and outlet ducts that are respectively connected to a source of medicinal fluid and a patient. The set of control valves and a pair of first and second syringes are interconnected between the inlet and outlet ducts. The control valve assembly is first operated to connect in a communicable manner to the fluid source and the first syringe and medicinal fluid being transmitted from the source to the first syringe. The set of control valves is then adjusted to connect communicably to the first and second syringes while isolating the first syringe and second syringe from the fluid source. The first syringe is then operated to transmit medicinal fluid from the first syringe to the second syringe through the set of control valves. The second syringe and the outlet duct are then communicably joined by adjusting the set of control valves and the second syringe being operated to transmit medical fluid from the second syringe to the patient through the outlet duct. The first syringe and fluid source remain isolated from the second syringe.
    [00024] Other objectives, characteristics and advantages of the invention will become apparent from the detailed description of a preferred configuration with respect to the attached drawings, presented in an exemplary and non-limiting manner, in which:
    [00025] - Figure 1 is a simplified schematic and partially plan view of the system for controlled release of medicinal fluids according to this invention;
    [00026] - Figure 2 is a view similar to Figure 1, where the set of control valves is enlarged to clarify and the internal construction of the set of valves being illustrated;
    [00027] - Figure 3 is a simplified schematic view of the outlet conduit and an alternative lower component that can be used to interconnect the outlet conduit to the patient's catheter;
    [00028] - Figure 4 is a view similar to those of Figures 1 - 3, which represents a medication delivery syringe being connected to the lower component by means of a connection tube;
    [00029] - Figure 5 is a perspective view of a set of control valves indicating a double handle to operate the stopcock and indicating that the pair of flow ports is open;
    [00030] - Figure 6 is a partial and elevated schematic view of an alternative system according to this invention using a pair of multi-directional valves for the control valve assembly; and
    [00031] - Figure 7 is a perspective view of multi-directional valves used in the configuration of Figure 5.
    [00032] A system 10 is shown in Figures 1 and 2 for the controlled release of dosages of a medicinal contrast fluid such as carbon dioxide (CO2) for use in radiological images of arteries and veins of a patient's vascular system. Although this is a preferred application of the system 10, it should be understood that the system can be used for the controlled release of various other types of fluids and gases administered as part of varied medical and surgical procedures. As used here, "fluid" should be understood to include various types of medicinal liquids and gases. By the same term, when “gas” is used here, it should be understood as a similar description applied to various types of medicinal liquids.
    [00033] System 10 includes an inlet duct 12 and an outlet duct interconnected by a three-stage K-shaped valve control assembly 16. Inlet duct 12 interconnects in a manner communicable to a source of carbon dioxide or other medical fluid (not shown) with valve assembly 16. Output duct 14 similarly interconnects with a discharge end of valve assembly 16 with a catheter 18, that is, in turn, operated in a manner connected to a patient, not shown.
    [00034] Inlet conduit 12 includes a Luer ™ 20 component having a G-22 sealing tube, which is selectively connected to the source of the medical fluid, such as the CO2 source. It should be understood that System 10 may be used with a variety of carbon dioxide sources, including but not limited to pressurized tanks, bags, and CO2mmander® manufactured by PMDA, LLC of North Fort Myers, Florida. The specific source of carbon dioxide or other medicinal fluid is not a limitation of the invention. A one-way directional valve 24 with the Luer ™ 26 component is communicably connected to component 20. Component 26 is in turn connected to a medical metal tube 28 having a length of approximately 18 ”. Various alternative lengths may be employed within the scope of this invention. The distal end of the tube leads to a Luer ™ 30 member.
    [00035] The 16 stage triple control valve set includes a K 32 shaped valve body, which is preferably composed of various medical grade plastics, metals and / or metal alloys. Typically, the valve body includes a molded or even unitary construction. The valve body indicates four fluid transmission ports 34, 46, 48 and 40. More particularly, the valve body 32 includes an aligned inlet and discharge segments 34 and 36, respectively, as best shown in Figure 2, including respective aligned internal input and output ports 38 and 40 respectively. The valve body further includes first and second intermediate legs 42 and 44. Each leg extends at a substantially 60 degree angle from aligned branches 34 and 36 of the valve body 32. Leg 42 includes an interior intermediate port 46 and a leg 44 including an inner intermediate door 48, which extends transversely axially through the respective legs 42 and 44. The doors 46 and 48 form substantially 60 degree transverse angles for each of them with the respective axial doors 38 and 40 of the branches aligned 34 and 38.
    [00036] The cross legs 42 and 44 still extend at an angle of substantially 60 degrees to one another. Likewise, the longitudinal axes 46 and 48 form an angle of substantially 60 degrees.
    [00037] Valve set 16 further includes a stopcock 59 which, best shown in Figure 2, is pivotally mounted inside the valve body 32. The stopcock includes an angled channel 61 comprising channel segments communicably interconnected 63 and 65 having respective longitudinal axes that extend at an angle of approximately 60 degrees to one another. As used herein, "approximately 60 degrees" should be understood to mean that the angle formed between the respective longitudinal axes of the channel segments 63, 65 is substantially equivalent to the angle formed between the respective longitudinal axis pairs of adjacent non-aligned doors of the body. valve 32 (for example, of the respective pairs of ports 36, 46; 46, 48; 48, 40). This makes it possible for the segments of the channels to be communicated in line with a selected one for adjacent ports in a more fully described manner below. It should be understood that in alternative configurations the ports of the segments of the channels may have other corresponding angles. This is particularly applicable when the inlet and outlet ports and / or the inlet and outlet ducts are not aligned.
    [00038] As shown in Figure 1, a valve lever 67 is mounted to the valve body 32 to selectively rotate the stopcock in one of the three selected positions. For example, in Figure 2, the stopcock is positioned with the segments of channels 63 and 65 of angular channel 61 aligned in a communicable manner with the adjacent doors 38 and 46 respectively. Alternatively, and as described below, lever 67 can be manipulated to align the segments of the channels, with the respective ports 46 and 48 as indicated by the channel shown in position 61b. The lever can also be operated to align the respective channel segments with ports 48 and 40 as indicated by the angled channel at position 61c. Said selective positioning of the stopcock provides the controlled release of multiple stage of the fluid through the valve 16 from the inlet duct 12 to the outlet duct 14. This operation will be better described below.
    [00039] The inlet branch 34 of the valve body 32 carries a complementary component to interconnect in a communicable manner to the Luer ™ 30 component conducted at the distal end of the pipe 28. Similarly, the discharge branch 36 of the valve body 32 conducts a complementary component to operate the interconnection in a communicable manner with the Luer ™ 50 component conducted at the end near the outlet conduit 14. The remaining elements of the discharge conduit will be described in greater detail below. Aligned ports 38 and 40 of valve body 32 include respective one-way valves 52 and 54, Figure 2 which restricts the flow limit of the fluid inside the respective ports 38 and 40 to the direction indicated by arrows 56 and 58.
    [00040] As further illustrated in Figures 1 and 2, the outlet conduit 14 indicates a medical metallic tube 60 which is interconnected between the Luer ™ 50 component connected to the discharge branch 36 of the valve body 32 and a second Luer component ™ that communicably connected to the lower valve 64. The lower valve includes a one-way valve 66 that restricts the flow of fluid from pipeline 14 through valve 64 to the direction indicated by arrow 68. Valve 64 indicates a G-tube 73 which prevents air from being introduced into the system before connecting valve 64. Valve 64 also includes a stopcock 70 which is rotationally operated inside valve 64 to selectively purge or bleed system fluid 10 through a port 72. Exit port 74 is selectively attached to the patient's catheter 18. Several alternatives and two or three stopcock can be used on the lower valve. A reservoir syringe 80 is communicably connected to the axial port 46 of valve leg 42. Said interconnection is accompanied by a conventional Luer ™ 82 component, the details of which are known to a person skilled in the art. Similarly, a second collector pick-up syringe 84 is loosely connected by a Luer ™ 86 component to the distal end of the valve leg 44. This allows the syringe 84 to be interconnected in a communicable manner with port 48 via the second intermediate leg 44. The syringes 80 and 84 are constructed and operated in a manner that is known to a person skilled in the art.
    [00041] System 10 is operated to release CO2 or other medicinal fluid to a patient in a reliable, safe and controlled manner. The operation is carried out as follows.
    [00042] Inlet conduit 12 is first interconnected between a carbon dioxide source and inlet branch 34 of valve body 32. Outlet section 14 is interconnected in a communicable manner between discharge branch 36 of valve body 32 and the lower valve 64, which is properly connected to the patient's catheter 18. Syringes 80 and 84 are attached to the legs of valves 42 and 44 so that the syringes communicate with the respective ports 46 and 48. The syringes must be selected so that they have a size that accommodates a desired volume of gas to be administered to the patient during the radiological image or other medical / surgical procedure.
    [00043] After the K-shaped multi-stage valve set 16 has been interconnected in the inlet and outlet ducts 12 and 14, and following the connection of syringes 80 and 84 to the respective valve legs 42, 44, the tap bypass 59 is operated by the valve lever 67 to align the legs 63 and 65 of the bypass channel 61 with the valve ports 38 and 46 respectively (see Figure 2). The CO2 source is then opened or upside down operated as required to release gas through inlet conduit 12 to valve 16. More particularly, gas is released through a one-way valve 24 and tubing 38 to inlet port 38. A unidirectional valve 52 prevents the return of gas flow in the metallic pipe 28. The CO2 proceeds in the direction indicated by the arrow 56 and is transmitted through the channel of the angled stopcock 61 in the port 46 of the leg in the valve 42. From here, the gas proceeds as indicated by the arrow 90 through component 82 and into the reservoir syringe 80. CO2 is introduced into the reservoir syringe 80 in this way until the syringe is filled.
    [00044] When the syringe of reservoir 80 is refilled, the operator manipulates the handle 67, Figure 1, and rotates the control valve in the second position of the stopcock channel represented by 61b in Figure 2. In that position, the segment of the channel 63 is communicably aligned with port 46 and channel segment 65 is communicably aligned with port 48. Plunger 81 of reservoir syringe 80 is pressed and the gas previously deposited in syringe 80 is transmitted through port 46 and the angled stopcock channel 61b in port 48. Thereafter, gas is introduced into the withdrawal syringe 84 as indicated by arrow 92. When this operation occurs, only the transverse intermediate ports and their attached syringes are connected. Both syringes remain completely insulated from both the inlet port 38 and the discharge port or outlet port 40. Likewise, the carbon dioxide source is connected in a communicable manner to the inlet port 38 being isolated from the discharge port 40 and the outlet conduit 14 connected to catheter 18. The patient is then safely protected from being inadvertently administered by a dangerous dosage of carbon dioxide directly from the source.
    [00045] After the gas is transferred from the reservoir syringe 80 to the withdrawal syringe 84, the operator manipulates the valve lever 67 to turn the stopcock 79 to the third position, which is represented by the stopcock channel in the position 61c. Thus, the segment of channel 63 is aligned in a communicable manner with port 48 and the segment of channel is similarly aligned with the segment of channel 40. To deliver CO2 in syringe 84 to the patient, the plunger 83 of syringe 84 is depressed in the direction of arrow 96. The gas is thus released through port 48 and the stopcock channel 40.
    [00046] Thereafter, the gas passes in the direction indicated by the arrow 58 through the withdrawal valve 64 in the pipeline 60. CO2 is then transmitted in the direction indicated by the arrow 58 through the withdrawal valve 54 and in the piping of the outlet section 14. The check valve 54 prevents the gas flow from returning to the K valve assembly.
    [00047] Lever 67 can be configured as an arrow or even marked to include an arrow that points in the direction of the intended fluid flow. With the lever pointing towards the reservoir 80, as shown in Figure 1, the angled channel 61 is in the position shown in Figure 2 and the fluid flow is directed towards the reservoir 80. Alternatively, the lever can be rotated to point towards syringe 84. In this position, the channel will be in position 61b shown in Figure 2 and the CO2 will be directed from syringe 80 to a syringe 84. Finally, in the third stage of the process, lever 67 can be directed to point in the direction the discharge end of port 40 and the connected outlet section 14. At this stage, the angular channel 61 is directed to position 61c, shown in Figure 2, so that the flow of fluid is directed from reservoir 84 to the section of exit 14.
    [00048] Co2 is released through the tube 60 and the lower valve 64. Once again, a one-way valve 66 prevents the flow of gas back into the pipe. The stopcock 70 is operated, as required, to direct CO2 to catheter 18 and thus to the patient, or to purge the gas through port 72. The G-73 seal prevents air from entering the line.
    [00049] Accordingly, system 10 allows controlled amounts of CO2 to be released to the patient in a safe and reliable way. After the components are connected, they can remain connected during the entire medical procedure and not have to be disconnected and reconnected. This minimizes the possibility of air entering the system and endangering the patient. Precise and controlled dosages of CO2 are released by simply operating the valve stopcock 16, reservoir syringe 80 to withdrawal syringe 84 and then to the patient. At each stage of the process, the inlet and outlet ends of the valve remain completely isolated from each other so that the risk of delivering a deadly dose of CO2 is eliminated.
    [00050] Figure 3 shows a discharge branch 36 from the valve assembly 16. A one-way valve 64 is installed again in port 40 to prevent the flow of gas back into the valve assembly 16. In this version, the pipe 60 is connected in a communicable manner between the discharge branch 36 and the component 100 which can be used selectively to perform various functions. In particular, component 100 includes a one-way valve 102 that prevents the flow of gas back into tube 60. Component 100 includes a Luer ™ 104 component that allows element 100 to be slidably attached to catheter 18. A discharge port 106 is unit communicable with component 100 and indicates a G-seal valve 108 that allows a syringe (not shown) to be interconnected to port 106. The syringe can be used to deliver medications through component 100 to be connected to the catheter 18. As a result, these medications can be administered to the patient without having to disconnect the individual components of the fluid delivery system. This saves valuable time in a medical or surgical environment and reduces the risk of air being introduced into the system. A syringe can also be connected to port 106 to purge or discharge the catheter when necessary or desired.
    [00051] Fig.4 represents another configuration of this invention where the medical tube 60 is interconnected in a communicable manner between the discharge branch 36 of the valve assembly 16 and a component 100a. The lower component also includes a one-way valve 102a to prevent the gas flow of a medication back into tube 60. A Luer ™ 104a component slidably interconnects component 100a to catheter 18. An inlet / discharge port 108a is formed in the component 100a to selectively introduce medication into the patient's catheter through component 100a alternatively purging or discharging the catheter as required. A line 110 is communicably connected to port 108a leading to its opposite end of the Luer ™ 112 component to slide the line to syringe 114. The syringe is connected to line 100 through component 112 in order to optionally deliver medication to the catheter 18 through component 100a in the direction indicated by arrow 116. Alternatively, the fluid can be purged or discharged in the direction of arrow 121 of the catheter and / or the system via line 110 through the flat shaft 120 of syringe 114 in the directions indicated by the arrow 122.
    [00052] In alternative versions of this invention, the medical fluid may be transmitted from a source to a patient in multiple stages, as described above, but using multiple valves attached to the respective syringes. In particular, in a first stage of operation, either gas or other fluid under pressure is released from a source through a first directional valve to a reservoir syringe connected in a communicable manner to a first valve. The reservoir syringe is also connected via the first valve to a second valve, which in turn is communicably connected to a second syringe. The first valve is operated so that the reservoir syringe remains isolated from the second valve when fluid is released from the source to the first syringe through the first valve. When a selected volume of fluid is accommodated by the first syringe, the first valve is operated to connect the first syringe with the second valve. The second valve itself is operated to connect the first syringe to the second syringe in a communicable manner. While at the same time, isolating the second syringe from the patient. The second syringe is a withdrawal syringe. The first syringe is operated with the second valve in the above position to transmit fluid from the first syringe to the second syringe. During this stage of the operation, both syringes remain isolated from the source and the patient.
    [00053] As a result, even if the fluid under pressure is “stacked” in the reservoir syringe, this pressure will not be released to the patient. Instead, the desired volume of the fluid will be delivered to the withdrawal syringe. The second valve is then operated to connect the communicable syringe to the patient's catheter in a communicable manner. Once again, the patient's catheter will be completely isolated from the pressure fluid source. As a result, a selected volume of the fluid is released from the withdrawal syringe to the patient.
    [00054] Various configurations of valves and types of directional valves can be performed for multistage release as described above. In all versions of this invention, it will be important that the fluid is first released from a fluid source to a first syringe and then released sequentially to a second syringe. Ultimately, the fluid in the second withdrawal syringe is released sequentially to the patient. During each stage of the process the fluid source remains isolated from the patient. Typically, only one stage of the system operates at any given time.
    [00055] As shown in Fig.5, a set of alternative control valves 16a, which again indicates a valve body generally in the form of K32a composed of materials similar to those previously described. The aligned inlet and outlet duct sections 34a and 36a, as well as the angular or intermediate duct sections 42a and 44a are selectively interconnected to communicate and transmit fluid flow through the respective duct pairs via an analog swivel valve. the one shown in the previous configuration. In this version, the stopcock is rotated by a double handle lever 67a, which includes elongated handles 69a and 71a. These handles diverge from the hub of the stopcock lever at an angle of approximately 60o, which equals the angle between each adjacent pair of fluid transmission ducts 34a, 42a, 44a and 36a in the control valve 16a. Each of the handles 69a and 71a is elongated and carries a respective directional arrow 73a which is either embossed or formed along the handle.
    [00056] The valve lever 67a is turned to operate the stopcock so that a selected pair of adjunct ducts or ports are communicably interconnected to allow fluid flow between them. In particular, the stopcock is constructed so that the handles 69a and 71a are aligned and extend along the respective ducts that are communicably connected by the stopcock. In other words, the valve handle 67 is rotated axially until the handles 69a and 71a are aligned with adjunct ducts through which
    [00057] Fluid flow is required. The angle between the handles is equal to the angle between the adjacent conduits, for example 60 degrees. The lever 67a can thus be rotated to align the divergent handles 69a and 71a respectively with the conduits 34a and 42a, 42a and 44a, or 44a and 36a. In Fig.5 the handles are aligned with conduits 44a and 36a, and the arrows 73a pointing in a direction that is substantially aligned with those conduits. This indicates that the valve lever 67a is rotated and adjusted so that the fluid is enabled to flow through the valve body 32a from the intermediate conduit 44a to the outlet conduit 36a. The valve lever is rotated to selectively align with other pairs of ducts and thus open the flow of fluid between the selected pair. The use of a double handle valve lever 67a clarifies and facilitates the use of the control valve set. In contrast, the valve lever used in the version of Fig.5 is constructed and operates in a similar way to the valve lever shown in Fig. 1-3.
    [00058] Fig.6 demonstrates a system 210 according to this invention where the control valve set comprises a pair of multidirectional valves 216 and 316, shown individually in Fig.6. These valves are used to carry out the multistage release of a medical gas such as CO2 or other medical fluid to a patient in a manner similar to that previously described. Valves 216 and 316 comprise standard multidirectional valves of the type manufactured by Value Plastics, which are suitable for use in medical applications. Said valves automatically respond to a predetermined fluid pressure allowing the fluid to flow through at least one valve path and restricting said flow through at least another valve path. The construction of the multidirectional valves will be understood by a technician in the subject who knows the state of the art.
    [00059] Valve 216 includes ports 219,221 and 223, which are interconnected in an incommunicable manner in a T-shaped configuration. Valve 316 similarly includes ports 319,321 and 323 which are communicably interconnected in a T-shaped configuration. Port 323 comprises a Luer connector having a lock 331 on it.
    [00060] More particularly, port 223 of valve 216 typically comprises a male Luer component which is connected to a Luer lock 225 driven at the discharge end of a first reservoir syringe 280. Inlet port 219 is interconnected via a pressure valve. path check 227 to an inlet conduit 212. The opposite end of that inlet conduit is connected in a communicable manner to a pressurized supply of medicinal fluid in a manner analogous to that previously described. The third port 221 of valve 216 is pressed into port 319 of the second multidirectional valve 316. Port 321 of valve 316 is connected to a Luer lock 351 formed at the discharge end of a second withdrawal syringe 384. Lock 331 of the Luer outlet 323 allows valve 316 to be connected to a Luer 357 component of a lower directional valve 364. The lower directional valve comprises a rotary valve that also includes ports 369 and 361. These ports are selectively interconnected to port 357 within the valve body. 364 and collectively defining a T-shaped configuration. A directional valve lever is rotated when necessary to align two of the respective ports. More particularly, the handle of the lever is directed along and aligned with one of the selected doors 357,359 and 361 so that the doors communicate in a known manner.
    [00061] Port 359 of valve 364 is properly interconnected via a standard Luer component 381 to a line 383. Port 361 is communicably connected via a Luer component 385 to a one-way valve 366 that is properly connected to an outlet conduit, that is, a catheter 318 delivered to the patient.
    [00062] The lower directional valve 354 is operated when required for blood or excess gas purged from the system 210 (ie by handling and aligning port 361) or to deliver a selected dosage of medication, contrast agent or other radioscopic substance to the patient (that is, by handling and aligning port 357 so that line 383 and catheter 318 are connected in a communicable manner).
    [00063] The lower directional valve 364 is adjusted in a rotating manner in a manner known to a person skilled in the art. This valve can be used for various functions within the scope of this invention. It should also be understood that several other types of locks, seals and / or connections may be used between the respective components of the 210 system.
    [00064] System 210 is operated to deliver medical gas or other fluid to a patient in the following manner. In a first stage of operation, gas or other fluid under pressure is released from a source or supply (as previously described) to the reservoir syringe 280 by connecting the supply to the conduit and opening the supply. CO2 or other medical fluid under pressure is released through inlet conduit 212 and check valve 227 at port 219 of multidirectional valve 216. The multidirectional valve is constructed and operates in a known manner so that the pressurized medical fluid effectively opens the valve to interconnect ports 219 and 223. The fluid is thus transmitted through the Luer 225 component in the reservoir of the first syringe 280 and the P1 plunger of the syringe retracting in the direction of the arrow 291.
    [00065] When the syringe of reservoir 280 is loaded, the operator depresses the plunger P1 in a conventional manner. This presses the fluid from the reservoir syringe 28 back through port 223 of valve 216. The pressure created by the depression of plunger P1 motivates the multidirectional valve 216 to open a communication path between port 223 and aligned port 221. The fluid medical device of the first syringe 280 is thus pressed through valve 316 and released from port 221 to port 319 of the second multidirectional valve 316. At the same time, check valve 227 prevents fluid from being transmitted back through inlet conduit 212 to the gas or liquid supply.
    [00066] When the fluid under pressure is released through port 319 to valve 316, the second multidirectional valve opens a communication path between ports 319 and 321. The medical fluid is thus transmitted through those interconnected ports and through the Luer 351 component to the reservoir of the second withdrawal needle 384. In the second stage of the process, the fluid is released from the first syringe 280 to the second syringe 384 while remaining isolated from the fluid supply. The P2 piston of the second syringe retracts in the direction of arrow 295 when its reservoir is loaded. The valve 316 restricts the flow of fluid during this stage to the path defined by the interconnected communication ducts 319 and 321.
    [00067] The third stage of the process is completed by the depression of the P1 embolus.
    [00068] This motivates valve 316 to open a communication flow path between ports 321 and 323 and restricting the gas or liquid from being transmitted back through port 319. Valve 316 transmits fluid from syringe 384 through the valve lower directional valve 364, and check valve 366 to catheter 318. During this third stage of the process, handle 373 is typically pointed towards aligned port 359 so that ports 357 and 361 of valve 364 are communicably connected. Handle 373 is shown as pointed at a “nine o'clock” position in Figure 6 for purposes of explanation in order to better illustrate valve ports 364. Through operating syringe 384, a selected dosage of gas or medical liquid is released through the catheter 318 to the patient.
    [00069] Valve 364 is operated in the manner previously described, to perform desired functions with a radioscopic procedure. For example, to assist a medication or radioscopic compound (such as a contrast agent) the handle 373 is typically pointed downwards (at a six o'clock position) so that ports 359 and 361 are joined together in a communicable manner. The desired substance to be added is then introduced via line 383 and valve 364 to catheter 318, and is thus administered to the patient.
    [00070] Alternatively, the gas can be purged from the system by the handle turned 373 so that it points towards the aligned port 361 and the catheter 318. This interconnects the ports 357 and 359 in a communicable way so that the excess gas can be discharged via line 383. Accordingly, in any of the configurations of the invention, the system can be quickly and conveniently purged and the medication can be added to the administered gas in a quick and convenient manner. In this case, the system does not have to be disconnected, disassembled, or reassembled. This saves considerable time and effort by significantly reducing the possibility of air being introduced into the system.
    [00071] System 210 may be modified to include particular characteristics and components as described in the configuration of Fig.1-4. In addition, the particular means of the valve interconnection, sealing and operation component may be modified so that it is understood by a person skilled in the art with knowledge of the prior art to obtain the operation and the resulting benefits exhibited by this invention.
    [00072] The use of multiple syringes is particularly critical and eliminates the risk of stacking that often occurs when a medical fluid is released under pressure directly from a fluid source to a single release syringe. In this case, the syringe can be loaded with a fluid that exceeds the syringe's nominal volume due to the pressure stacking. If said fluid is released directly to the patient, this could result in a potentially dangerous overdose or blood fluid. By transmitting fluid from a reservoir syringe into a withdrawing syringe, the pressure will be equalized and only the fluid volume and the pressure accommodated by the second syringe will be released safely to the patient.
    [00073] From this, it can be seen that the apparatus of this invention provides a system for the safe release of a controlled volume of a medical fluid to a patient and, more particularly, a system for releasing a controlled flow of carbon dioxide ( co2) or other contrast medium in order to obtain radiological images. While this detailed description has been established particularly for preferred configurations of the apparatus of this invention, numerous modifications and variations of the structure of this invention, all within the scope of the invention, will be possible to occur. Accordingly, it will be understood that this description is illustrative only for the principles of the invention and does not limit it.
    [00074] Although specific features of the invention are shown in some of the drawings and not in others, this is for convenience only, so that each feature can be combined with any or other of the features according to the invention.
    权利要求:
    Claims (26)
    [0001]
    1. "SYSTEM FOR CONTROLLED RELEASE OF A MEDICINAL FLUID" from a source of said fluid to a patient consisting of an inlet duct (12) being communicable joined to a source of medicinal fluid, an outlet duct (14) being communicable together to the patient, first and second syringes (80, 84) a control valve set (16) interconnecting said inlet and outlet (12, 14), and said first and second intermediate syringes (80, 84), said set of valves being alternated between a first state where said inlet conduit (12) communicates with said first syringe (80) for the transmission of fluid from the source to said first syringe (80), a second state where the first syringe (80) communicates with said second syringe and being isolated from said inlet and outlet conduits for the transmission of fluid from the first syringe (80) to the second syringe, and a third state where said second syringe communicates with said conduit outlet (14) (14) and being isolated from said inlet conduit (12) and said first syringe (80) for transmitting fluid from said second syringe to said outlet conduit (14) said set of control valves include a valve body (32) having inlet and outlet ports (38, 40) aligned that are communicably connected to said inlet and outlet ducts respectively, said valve body (32) still including a first and second pair intermediate doors (46, 48) which extend transversely axially to said inlet and outlet ports (38, 40) and transversely axially to each other, said set of valves still including a stopcock (59) mounted in a manner rotatable within said body and including a channel consisting only of a first channel segment and a second channel segment, said first channel segment consists of a first end and a second segment underneath the end of said first segment being adjacent the periphery of said stopcock (59) to align with said inlet port (38), said first intermediate port, and said second intermediate port and said second end of said first segment being centrally located with said stopcock (59) of the second segment consisting of a first end and a second end of said first end of said second segment being adjacent to the stopcock (59) to align with said first intermediate door , said second intermediate door and said exit door and said second end of said second segment being centrally located with the stopcock (59) and in fluid communication with said with said second end of said first segment characterized by said first and second cane segments is are selectively aligned with said intermediate inlet and outlet ports to allow communication between said inlet conduit (12) and said first syringe and said second intermediate port and said outlet port to allow communication between said second syringe and said outlet conduit.
    [0002]
    2. "SYSTEM" according to claim 1, characterized in that said channel includes a pair of segments of communication channels that extend axially at an acute angle to each other.
    [0003]
    3. "SYSTEM" according to claim 2, characterized in that said first state, said segments of channels connecting in a communicable manner to said inlet port and to said intermediate port where the fluid introduced in said inlet conduit (12 ) be transmitted through said inlet port and said intermediate port to said first syringe.
    [0004]
    4. "SYSTEM" according to claim 2, characterized in that in said second state, said stopcock aligns with said segments of channels with said first and second intermediate ports respectively to isolate the fluid in said first syringe (80) from both inlet and outlet ducts and to direct the fluid from said first syringe (80) through said first intermediate port, said channel and said second intermediate port in the second syringe.
    [0005]
    5. "SYSTEM" according to claim 2, characterized in that in said third state, said stopcock aligns with said segments of channels and with said second intermediate door and said exit door respectively to isolate the fluid in said second syringe from said source, said inlet port and said intermediate port for the transmission of fluid through said second intermediate port, said channel and said outlet port to said outlet conduit (14).
    [0006]
    6. "SYSTEM" according to claim 1, characterized in that said entrance and exit doors include respective longitudinal axes that are aligned.
    [0007]
    7. "SYSTEM" according to claim 1, characterized in that said first and second intermediate doors include respective longitudinal axes that form an angle of substantially 60 degrees with the other.
    [0008]
    8. "SYSTEM" according to claim 1, characterized in that the intermediate door forms an axial angle of substantially 60 degrees with longitudinal axes of said entrance door and where the longitudinal axis of said second intermediate door forms an angle of substantially 60 degrees with the longitudinal axis of said exit port.
    [0009]
    9. "SYSTEM" according to claim 2, characterized in that the segments of the channels have respective longitudinal axes that form an angle of substantially 60 degrees.
    [0010]
    10. "SYSTEM" according to claim 1, further characterized by including a first unidirectional valve to restrict the flow of fluid to a single direction of the fluid source to said set of control valves and a second unidirectional valve to restrict the fluid flow in a single direction from the control valve set through the outlet conduit (14) to the patient.
    [0011]
    11. "SYSTEM" according to claim 1, further characterized by including a lower valve connected to said outlet duct (14) for at least one blood fluid from said system and administering an additive fluid to the medical fluid transmitted through the said outlet duct (14).
    [0012]
    12. "SYSTEM" according to claim 1, characterized in that said set of control valves includes a distinct pair of first and second control valves interconnected to respectively interconnect to said first and second syringes and to respectively interconnect said first syringe (80) to the fluid source and the second syringe to the patient.
    [0013]
    13. "SYSTEM" according to claim 1, characterized in that each of said valves includes three selectively interconnected ports, said first valve having a first port communicably connected to said inlet conduit (12) and a second port connected communicable way to said first syringe, said second valve having a first port connected in a communicable way to the inlet and outlet ducts and a second port connected in a communicable way to said second syringe, said first and second valves having respectively third ports that are interconnected between itself.
    [0014]
    14. "SYSTEM" according to claim 14, characterized in that each of said valves is a multidirectional valve, referred to the control valve being selectively operated to release fluid from the source to said first syringe (80) and alternatively from said first syringe ( 80) to said third port of said second control valve, said second control valve being selectively operated to deliver fluid from the first valve to the second syringe and alternatively from said second syringe to the patient through said outlet duct (14).
    [0015]
    15. "SYSTEM" according to claim 2, characterized in that said stopcock is rotated by a fixed lever having a stop of diverging handles that are aligned with the respective ports of said valve body to indicate that the respective ports are connected in a communicable manner by said channel of said stopcock.
    [0016]
    16. “METHOD USING THE SYSTEM FOR CONTROLLED RELEASE OF A MEDICINAL FLUID DEFINED IN CLAIM 1”, from a source of said fluid to a patient in controlled doses, characterized by including the provision of inlet and outlet ducts connected respectively to a source of medical fluid and a patient, the provision of a first and second syringe and a set of control valves, which are interconnected between the inlet and outlet ducts, operating the control valve assembly to connect in a communicable manner to the fluid source and the first syringe (80) and transmitting medicinal fluid from the source to the first syringe, adjusting the set of control valves to connect communicably with the first and second syringes while isolating the first syringe (80) from the fluid source, operating at first syringe (80) to transmit medicinal fluid from the first syringe (80) to the second syringe through the set of control valves, adjusting the set control valves to be connected in a communicable manner to the second syringe to the outlet duct (14) and to isolate the first syringe (80) and the fluid source of the second syringe, and operating said second syringe to transmit medicinal fluid from the said second syringe to the patient through the outlet conduit (14), said first and second intermediate ports include respective longitudinal axes that form an angle to each other, said first intermediate port forms an angle with longitudinal axis of said entry port which is equivalent to the angle formed by said longitudinal axes and said second intermediate door forms an angle with the longitudinal axis of said exit door which is equivalent to the angle formed by said longitudinal axes of said first and second intermediate doors and said first and second channel segments have respective axes that form an angle equivalent to the â angle formed by the longitudinal axes of said first and second intermediate doors.
    [0017]
    17. “VALVE ASSEMBLY TO CONTROL THE SYSTEM FOR CONTROLLED RELEASE OF A MEDICINAL FLUID DEFINED IN CLAIM 1”, characterized by comprising a valve body (32) including first, second, third and fourth transmission ports, and a tap element valve mounted movably in said valve body (32), said stopcock element having a fluid transmission channel extended between them, said channel being configured to allow said stopcock element to be moved alternately in said body valve (32) between a first state where said channel communicably interconnects said first port with said second port and said stopcock element isolates the first port from said third and fourth ports to transmit fluid from said first port for said second port, a second state where said channel is communicably interconnected said second door with said third door and said stopcock isolates said second door from the first and fourth doors to transmit fluid from said second door to said third door with the fourth door, and a third state where said channel communicably interconnects said third port with said fourth port and said stopcock element isolates said third port from said first and second ports to transmit fluid from the third port to said fourth port.
    [0018]
    18. "ASSEMBLY" according to claim 17, characterized in that said channel includes a pair of channel segments being axial and connected in a communicable manner from one acute angle to the other.
    [0019]
    19. "ASSEMBLY" according to claim 17, characterized in that said first and fourth doors respectively comprise entrance and exit doors that include respective longitudinal axes that are aligned with each other.
    [0020]
    20. "ASSEMBLY" according to claim 19, characterized in that said second door comprises a first intermediate door arranged between said entrance and exit doors and said third door comprises a second intermediate door arranged between said first intermediate door and said exit port.
    [0021]
    21. "ASSEMBLY" according to claim 20, characterized in that said first and second intermediate doors include respective longitudinal axes that form an angle of substantially 60 ° to another.
    [0022]
    22. "ASSEMBLY" according to claim 21, characterized in that the longitudinal axis of said first intermediate door forms an angle of substantially 60o with a longitudinal axis of said entrance door and a longitudinal axis of said third door forming an angle of substantially 60o with the longitudinal axis of said fourth door.
    [0023]
    23. "ASSEMBLY" according to claim 18, characterized in that said segments of the channels have respective longitudinal axes that form an angle of substantially 60o.
    [0024]
    24. "ASSEMBLY" according to claim 17, characterized in that said stopcock element is rotatable in said valve body.
    [0025]
    25. "ASSEMBLY" according to claim 24, characterized in that said stopcock element is rotated by a clamping lever having a pair of diverging handles which are respectively aligned with said channel segments.
    [0026]
    26. "ASSEMBLY" according to claim 22, characterized in that said channel includes a pair of channel segments that are communicably joined at an axial angle of substantially 60 ° to one another, said first intermediate entrance door, said first and second intermediate ports and said intermediate output ports, respectively defining pairs of adjacent ports, each pair of adjacent ports being connected in a communicable manner to said channel segments in one of the respective first, second and third states.
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    同族专利:
    公开号 | 公开日
    EP2688636A1|2014-01-29|
    CN103596619B|2016-01-20|
    JP2014514052A|2014-06-19|
    DK2688636T3|2016-04-18|
    EP2688636B1|2016-02-24|
    WO2012134593A1|2012-10-04|
    ES2568741T3|2016-05-04|
    AU2018203358A1|2018-05-31|
    AU2018203358B2|2019-10-31|
    CN103596619A|2014-02-19|
    HUE028945T2|2017-02-28|
    AU2016210652B2|2018-02-15|
    CA2831059A1|2012-10-04|
    US9757508B2|2017-09-12|
    MX2013010953A|2014-02-27|
    MX367973B|2019-06-27|
    AU2016210652A1|2016-08-18|
    JP5964942B2|2016-08-03|
    AU2012233160A1|2013-10-17|
    US20150297823A1|2015-10-22|
    AU2020200035B2|2021-03-18|
    AU2012233160B2|2016-05-12|
    EP2688636A4|2014-10-08|
    BR112013024475A2|2016-12-20|
    US20120065502A1|2012-03-15|
    AU2020200035A1|2020-01-30|
    US9050401B2|2015-06-09|
    HK1194696A1|2014-10-24|
    CA2831059C|2016-05-24|
    US20170368254A1|2017-12-28|
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    法律状态:
    2018-12-18| B06F| Objections, documents and/or translations needed after an examination request according art. 34 industrial property law|
    2019-10-01| B06U| Preliminary requirement: requests with searches performed by other patent offices: suspension of the patent application procedure|
    2020-09-01| B06A| Notification to applicant to reply to the report for non-patentability or inadequacy of the application according art. 36 industrial patent law|
    2021-01-05| B09A| Decision: intention to grant|
    2021-03-02| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 26/03/2012, OBSERVADAS AS CONDICOES LEGAIS. |
    优先权:
    申请号 | 申请日 | 专利标题
    US13/065,621|US9050401B2|2010-05-19|2011-03-25|System for controlled delivery of medical fluids|
    US13/065,621|2011-03-25|
    PCT/US2012/000164|WO2012134593A1|2011-03-25|2012-03-26|System for controlled delivery of medical fluids|
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