• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
  • 同族专利
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    • 专利摘要:
    SYSTEMS AND METHODS TO PROVIDE A HAZARDOUS CLOSED VENTILATION DRUG SET IV. The present invention relates to a device for loading and ventilating a dangerous drug within an intravenous administration set. The device includes several access ports and fluid channels to allow direct injection of a dangerous drug into the fluid reservoir, while eliminating the possibility of undesirable exposure to the dangerous drug. The device additionally includes loading and flushing ports to allow scanning of a dangerous drug in the system following an infusion procedure.
    公开号:BR112012028046B1
    申请号:R112012028046-5
    申请日:2011-04-14
    公开日:2020-12-08
    发明作者:Bryan G. Davis；Minh Quang Hoang
    申请人:Becton, Dickinson And Company；
    IPC主号:
    专利说明:

    Background of the Invention
    [001] The present invention relates to systems and methods for loading an intravenous (IV) administration set with a dangerous drug or chemical, as commonly used in the fields of medical therapy and infusion.
    [002] An intravenous administration set is typically used to apply or collect fluid from a patient, such as blood, a medication, a nutritional supplement or a solution. In some areas of medicine, the treatment of diseases and illnesses requires the infusion of dangerous chemical substances, such as toxic chemotherapeutic agents. Hazardous drugs are typically added to a fluid reservoir, such as an intravenous bag, and then administered to the patient via a patient line and an intravenous needle. Before administering the hazardous solution to the patient, the air inside the patient's conduit must be purged to prevent infusion of air into the patient.
    [003] Standard loading procedures involve compressing a drip chamber portion of the intravenous administration set to initiate the flow of the hazardous drug from the fluid reservoir. Once the flow is initiated, the dangerous drug continues through the patient's conduit, thereby displacing air into the conduit. However, in addition to displacing air from the duct, the flow of the dangerous drug also displaces dangerous vapors produced from the dangerous drug. Exposure to displaced dangerous vapors can result in indisposition, dizziness, nausea, vomiting, attacks, unconsciousness, and even death. In addition, the physician must carefully monitor the loading process to ensure that the hazardous drug does not leave the patient's conduit. Direct exposure to the dangerous drug can also result in the side effects mentioned above.
    [004] Thus, although techniques currently exist that are used to prepare an intravenous administration set for use with a dangerous drug, challenges remain. Consequently, there may be an improvement in the technique to expand or even replace the current techniques with other techniques. Brief Summary of the Invention
    [005] The present invention relates to systems and methods for providing a closed ventilation system for use in loading an intravenous (IV) administration set with a dangerous drug or chemical. Specifically, the present invention relates to an intravenous delivery system that incorporates several fluid ports and channels designed to minimize exposure to a dangerous drug or vapor within the intravenous delivery system.
    [006] The intravenous delivery system generally includes a coupling assembly for connecting a drip chamber to a fluid reservoir, such as an intravenous bag. In some embodiments, the coupling assembly includes a first fluid channel that provides fluid communication between the fluid reservoir and the drip chamber of the application system. In other embodiments, the coupling assembly additionally includes a second fluid channel that provides fluid communication between the fluid reservoir and an external access port. The external access port is coupled to an external surface of the coupling assembly or drip chamber and provides direct access to the fluid reservoir. In some embodiments, the access port is accessed by a syringe to deliver a dangerous drug to the fluid reservoir through the second fluid channel. In other embodiments, the access port additionally includes a valve or septum to seal the second fluid channel.
    [007] The intravenous set additionally includes a drip chamber connected fixedly to an outlet of the first fluid channel. The drip chamber generally includes a closed container configured to receive fluid from the fluid reservoir. In some embodiments of the present invention, the drip chamber additionally includes an external loading port. The loading port is attached to an external surface of the drip chamber, and is in fluid communication with it. In some embodiments, a charging solution is injected into the drip chamber through the loading port. The injected loading solution may be useful in loading a patient's conduit prior to infusion, or it may be useful in flushing the patient's conduit to remove the residual hazardous drug following the infusion procedure.
    [008] In other implementations of the present invention, the drip chamber and patient conduit of the intravenous administration set are loaded with the hazardous drug contained within the fluid reservoir. In some embodiments, undesirable exposure to the hazardous drug during the loading process is prevented by inserting an end end of the patient conduit into the coupling assembly access door. In this way, as the patient's conduit is loaded, hazardous gases are vented into the fluid reservoir through the access port. In this way, exposure to dangerous molecules is avoided.
    [009] In some embodiments of the present invention, the hazardous drug remaining within the intravenous delivery system is discharged from the system through a wash port. The wash port is usually positioned on an external surface of the IV system upstream of the patient's infusion site. In some embodiments, a syringe or other delivery device is coupled to the flushing port to apply a loading or flushing fluid to the intravenous delivery system. As such, the loading fluid discharges residual hazardous drug from the delivery system and from within the patient. In addition, in some embodiments, undesirable exposure to the dangerous drug is prevented by inserting the terminal end of the patient's conduit into a container, or a filtration system during the loading process. Brief Description of the Different Views of the Drawings
    [010] In order that the manner in which the aforementioned features and advantages and other features and advantages of the invention are obtained is readily understood, a more particular description of the invention briefly described above will be described with reference to the specific embodiments thereof which are illustrated in the attached drawings. These drawings show only typical embodiments of the invention and, therefore, should not be considered as limiting the scope of the invention.
    [011] Figure 1A is a perspective view of an implementation of an intravenous set that has a loading port.
    [012] Figure 1B is a perspective view of an implementation of a ventilated cover, according to a representative embodiment of the present invention.
    [013] Figure 1C is a cross-sectional view of an end end of an intravenous set that incorporates a ventilation membrane, according to a representative embodiment of the present invention.
    [014] Figure 1D is a cross-sectional view of an end end of an intravenous set that incorporates a ventilation membrane as attached to a luer device, according to the representative embodiment of the present invention.
    [015] Figure 2 is a cross-sectional view of an implementation of an intravenous set of the present invention that is loaded with a loading solution through the loading port.
    [016] Figure 3 is a cross-sectional view of an implementation of an intravenous set of the present invention coupled to an intravenous bag.
    [017] Figure 4 is a cross-sectional view of an implementation of an intravenous set of the present invention that is discharged with a loading solution through the loading port, following the infusion of a dangerous drug.
    [018] Figure 5 is a cross-sectional view of an implementation of an intravenous set of the present invention, wherein the intravenous set is coupled to an intravenous pouch and includes an access port.
    [019] Figure 6 is a cross-sectional view of an implementation of an intravenous set of the present invention, in which the intravenous bag is injected with a dangerous drug through an access port.
    [020] Figure 7 is a cross-sectional view of an implementation of an intravenous set of the present invention, in which a portion of a patient conduit is discharged with a loading fluid through a wash port.
    [021] Figure 8 is a cross-sectional view of an implementation of an intravenous set of the present invention that has a loading port and an access door.
    [022] Figure 9 is a cross-sectional view of an implementation of an intravenous set of the present invention in a charged state.
    [023] Figure 10 is a cross-sectional view of an implementation of an intravenous set of the present invention following the injection of a dangerous drug into an intravenous bag through an access port.
    [024] Figure 11 is a cross-sectional view of an implementation of an intravenous set of the present invention following the infusion of a dangerous drug into a patient, where the intravenous set is being discharged with a loading fluid through a port. loading.
    [025] Figure 12 is a cross-sectional view of an implementation of an intravenous set of the present invention in a closed ventilation configuration.
    [026] Figure 13 is a cross-sectional view of an implementation of an intravenous set of the present invention shown that ventilates a dangerous vapor in a separate container.
    [027] Figure 14 is a cross-sectional view of an implementation of an intravenous set of the present invention used in conjunction with a primary intravenous set. Detailed Description of the Invention
    [028] The presently preferred embodiments of the present invention will be better understood with reference to the drawings, where similar numerical references indicate identical elements or similar functionality. It will be readily understood that the components of the present invention, as generally described and illustrated in the Figures in this document, can be arranged and designed in a wide variety of different configurations. Thus, the following more detailed description, as represented in the Figures, has no The intention to limit the scope of the claimed invention, however, is merely representative of the presently preferred embodiments of the invention.
    [029] Referring now to Figure 1, an implementation of an intravenous (IV) 10 delivery system is shown. Some modalities of the intravenous delivery system 10 include a coupling assembly 20 that has a spike-type connector 30 configured for insertion into a fluid reservoir 12, as shown in Figure 3. Some implementations of the coupling assembly 20 comprise a material of rigid polymer, such as polystyrene, polyester or polypropylene. Some embodiments of the spike-type connector element 30 additionally include a chamfered end surface 32 to assist insertion of the coupling assembly 20 into a fluid reservoir 12.
    [030] In some embodiments, the coupling assembly 20 additionally includes a first fluid channel 60. The first fluid channel 60 provides a fluid path between a coupled fluid reservoir 12 and the drip chamber 40 of the IV system. 10. The first fluid channel 60 includes an inlet 62 and an outlet 64. Referring to Figure 3, inlet 62 is positioned inside fluid reservoir 12, and outlet 64 is coupled to an inlet 46 of the drip chamber 40 The outlet 64 of the first fluid channel 60 is positioned adjacent to the drip chamber 40, so that fluid 16 from the fluid reservoir 12 is collected in the drip chamber 40 via outlet 64. In some embodiments, outlet 64 includes additionally a tapered opening that allows fluid 16 to form in drops 18 before being collected in the drip chamber 40.
    [031] The drip chamber 40 is generally configured to receive the fluid 16 dispensed from outlet 64 of the first fluid channel 60. As previously discussed, outlet 64 is configured to allow fluid 16 to form in drops 18 at the as fluid 16 exits outlet 64. In some embodiments, the drip chamber 40 is generally cylindrical having a rigid upper portion 71 coupled in a sealed manner to a lower flexible portion 72. In some embodiments, manipulation of flexible portion 72 of the drip chamber 40 initiates the flow of a dangerous fluid or drug16 from fluid reservoir 12 into drip chamber 40. This process requires that system 10 be sealed by inserting spike-type connector 30 into a reservoir of sealed fluid 12, and obstructing a patient conduit 50 through a flow regulator 52, or similar fixation device. A vacuum is created in the drip chamber 40 by compressing and releasing the flexible portion 72 of the drip chamber 40. This compression displaces the air inside the drip chamber 40 into the fluid reservoir 12 thereby creating a pressure negative, or vacuum within the drip chamber 40. Negative pressure in the drip chamber extracts the hazardous drug 16 from the fluid reservoir 12 into the fluid reservoir 40 to form a second fluid reservoir 42 within the drip chamber 40, as conventional. Once flow regulator 52 is released, dangerous fluid 16 continues to flow from fluid reservoir 12 due to gravity. One skilled in the art will appreciate that other methods can be used to initiate the flow of the hazardous fluid 16 through the system, including gravity feeding methods or methods using a peristaltic pump.
    [032] Referring again to Figure 1, some embodiments of the present invention additionally include a self-sealing loading / washing port 44. The loading / washing port 44 is coupled to an external surface of the drip chamber 40. In some embodiments, the loading / flushing port 44 is positioned above the second fluid reservoir 42. In other embodiments, the loading / flushing port 44 is positioned adjacent to, or within the second fluid reservoir portion 42 of the drip chamber 40. The loading / flushing port 44 is in fluid communication with the interior of the drip chamber 40 is designed to receive a syringe 180 or other device configured to apply a loading / flushing solution 160 directly to the chamber drip 40. In some embodiments, the loading / flushing port 44 includes an opening 190 for receiving a tip portion 182 of a syringe 180. The loading port The flush / wash 44 additionally includes a split valve or septum 184 that is oriented in an open position by inserting tip 182 into opening 190. Prior to insertion of tip portion 182, valve or septum 184 forms an airtight seal that maintains , thus, the pressure inside the drip chamber 40 and the rest of the intravenous application system 10.
    [033] In some embodiments, the drip chamber 40 and patient conduit 50 are preloaded with a loading solution 160 through the loading / washing port 44. Referring now to Figure 2, the drip chamber 40 it is accessed through the loading / washing port 44 with a syringe 180 containing a loading fluid 160. In some embodiments, loading fluid 160 is a sterile solution of water containing a non-hazardous additive, such as sodium chloride or dextrose. The loading process of the drip chamber 40 and patient conduit 50 purges air from these components, thereby preventing the possibility of air being introduced into a patient during the infusion process.
    [034] In some embodiments, the intravenous delivery system 10 additionally includes a membrane 66 arranged in the drip chamber 40. The membrane 66 is configured so that air is prevented from leaving the drip chamber 40 inwards of the patient conduit 50. In this way, the membrane 66 acts as a bubble collector to capture any bubbles that might otherwise flow out of the drip chamber 40 and into the patient conduit 50. As illustrated in the Figures 13, the drip chamber 40 is connected to a patient conduit 50. The conduit 50 comprises a tube used to transport fluid 160 from the drip chamber 40 and the first fluid reservoir 12 to patient 100.
    [035] The membrane 66 is positioned in the lower portion of the drip chamber 40, in order to completely cover the drip chamber outlet 48. By positioning the membrane 66 to completely cover the chamber outlet 48, air is prevented from being captured between membrane 66 and outlet 48 as loading fluid 160 moves through membrane 66. Additionally, in some embodiments, membrane 66 comprises a hydrophilic material that is configured to interact strongly with the capturing fluid 16 thus, the fluid 160 within the membrane 66. In some embodiments, the membrane 66 comprises at least one of polytetrafluoro ethylene, hydrophilic nylon, hydrophilic polypropylene, hydrophilic polyether sulfone or a non-woven material coated with the above materials. As fluid 160 flows from the drip chamber 40 through membrane 66, fluid 160 captured within membrane 66 is displaced by incoming fluid 160, and displaced fluid 160 is forced into patient conduit 50. However , when the drip chamber 40 stalls, or when the fluid supply 160 of the drip chamber 40 has been exhausted, the fluid 160 within the membrane 66 is retained and the flow through patient conduit 50 ceases. In this way, the air inside the drip chamber 40 is prevented from passing through the membrane 66 and into the patient conduit 50.
    [036] In some embodiments, a flow regulator 52, or other fixation device, as well as a flow control plug or ventilation membrane 58 can also be connected to patient conduit 50. For example, in some embodiments, the membrane 58 is coupled to the patient conduit 50 via a coupling means, such as a luer connector or a friction interface. A regulator 52 allows the flow of fluid 160 out of the drip chamber 40 to be controlled and stopped. In some embodiments, the regulator is pre-programmed to allow fluid 160 to flow at a specific rate. In other embodiments, regulator 52 is used in combination with a pump or other device (not shown) configured to limit the flow rate of fluid 160.
    [037] The ventilation membrane 58 generally comprises a material or combination of materials necessary to provide various functions. In some embodiments, the vent membrane 58 is directly coupled to the end end 54 of the intravenous tube 50. In other embodiments, the end 54 is configured to include a recess or other feature for receiving the vent membrane 58, such as a compartment . In other embodiments, the dust cover 56 is modified to include a ventilation membrane 58, as shown in Figure 1B. Dust cap 56 may also include a plurality of air vents 110 configured to retain membrane 58 and still allow air to pass through membrane 58.
    [038] Ventilation membrane 58 can be configured to provide various functions required by the intravenous delivery system 10. For example, in some embodiments, ventilation membrane 58 is provided as a contaminant filter to protect end 54 from external contaminants . In other embodiments, the ventilation membrane 58 is provided as a hydrophobic air filter configured to allow air ventilation within the application system, and still prevent the passage of fluids 160.
    [039] In some embodiments, the ventilation membrane 58 comprises a porous material, such as polytetrafluoro ethylene, which has a plurality of pores dimensioned and configured to allow the passage of air, and still prevent the passage of larger molecules, such as a fluid, a dangerous solution or a dangerous solute. In another embodiment, the ventilation membrane 58 comprises a plurality of pores approximately sized from 0.1 to 0.5 microns, thus allowing it to pass through the pores, further preventing the passage of fluids and larger aerosolized particles or molecules of dangerous drug within the system 10. Thus, during the loading process of the system 10, the air inside the patient conduit 50 is allowed to escape from the conduit 50 through the ventilation membrane 58 while the fluid 160 and dangerous gases 24 are retained in conduit 50. Following the loading process, regulator 52 is engaged to obstruct conduit 50. Once obstructed, the end end 54 of conduit 50 is attached to the patient via a catheter 102, or a secondary intravenous line ( not shown).
    [040] In some embodiments, the ventilation membrane 58 comprises a 360 ° membrane that is designed to minimize the potential to pass the aerosolized form or gas of dangerous drugs that come in contact with the plug 58 during the loading process . The ventilation membrane 58 is thus configured to allow the passage of non-toxic air into the patient conduit 50, and further include structural or chemical resources to limit the passage of larger toxic molecules. These resources can include any technology or device capable of providing such restrictions.
    [041] For example, in some embodiments, the ventilation membrane material 58 comprises at least one of polytetrafluoro ethylene, hydrophilic nylon, hydrophilic polypropylene, hydrophilic polyether sulfone or a non-woven material coated with the above materials. The ventilation membrane 58 additionally includes restricted porosity, as discussed above, thereby limiting the passage of larger molecules. In other ways, the ventilation membrane 58 comprises a catalyst, such as activated carbon, which binds to the sequestered dangerous drug molecules, thus the dangerous molecules inside the buffer 58. In other embodiments, the ventilation membrane 58 comprises a composite of alternating layers of PTFE and carbon or activated carbon.
    [042] The flow rate of a fluid 160 through the duct 50 is determined by the rate at which air within the duct is allowed to flow through the vent membrane 58. In this way, the flow of fluid 160 through the duct 50 can be adjusted by increasing or decreasing the number and size of the pores of the plug 58. For example, in some embodiments, the flow rate of the ventilation membrane 58 is increased by increasing the pore diameter or by increasing the number of pores. In another embodiment, the flow rate of the ventilation membrane 58 is decreased by decreasing the diameter of the pores or decreasing the number of pores.
    [043] In some embodiments, the rate of air flow through the vent membrane 58 is configured to be equal to or less than the rate of fluid flow 160 through the membrane 66. Thus, in some embodiments, the rate of flow of the membrane 66 and the flow rate of the ventilation membrane 58 are combined to ensure the appropriate free bubble flow of the fluid 160 through the system 10. In some embodiments, the flow rate of the membrane 66 and the ventilation membrane 58 are combined to ensure that fluid 160 flows through membrane 66 at a rate that is slightly slower than the rate at which air ventilates through ventilation membrane 58. As such, fluid 160 forms a reservoir 76 in the second reservoir of fluid 42, as shown in Figures 2-4.
    [044] The fluid reservoir 76 provides a continuous bubble-free fluid source that flows from the drip chamber 40 and through the conduit 50 by displacing the air captured therein. In other embodiments, the flow rate of the vent membrane 58 is configured to be slower than the flow rate of the membrane 66, so that the flow rate of the fluid 160 through the conduit 50 is reduced to an optimum flow rate . In some embodiments, an optimum flow rate is the rate at which fluid 160 will efficiently and deeply displace air within conduit 50 during the loading process.
    [045] In these modalities that are configured to incorporate a membrane 66 and a ventilation membrane 58, the loading process of system 10 does not require the use of flow regulator 52, or any similar fixing device, as conventional. Preferably, the combination of membrane 66 and ventilation membrane 58 allows automatic loading of system 10. Specifically, since the charging fluid 160 is introduced into the drip chamber 40, fluid 160 automatically flows through the membrane 66 and the duct 50 until it reaches the vent membrane 58. In some embodiments, the drip chamber 40 additionally includes an air outlet 74, whereby a negative pressure within the drip chamber 40 is equalized to allow flow fluid 160 through membrane 66.
    [046] The position of the air outlet 72 in the drip chamber 40 is selected in order to determine the height of the second fluid reservoir 42. Thus, as the fluid 16 flows into the drip chamber 40, the height fluid 16 is prevented from exceeding the positioned height of the air outlet 72. When the height of the second fluid reservoir 42 exceeds the positioned height of the air outlet 72, the air outlet 72 is blocked by the fluid 16 and thus is prevented from venting and / or equaling the pressure inside the drip chamber 40. As such, positive pressure forms within the drip chamber 40 preventing the flow of fluid from the first fluid reservoir 12. As fluid 16 is released or flow into patient duct 50, the height of the second fluid reservoir 42 is returned to a lower position than the height of the air outlet 72 thereby allowing the air outlet 72 to release positive pressure within of the drip chamber 40. As the pressure inside the drip chamber 40 equals, the fluid flow from the first fluid reservoir 12 restarts.
    [047] In some embodiments, the air outlet 72 additionally comprises a filter (not shown) that is configured to capture or render the aerosolized dangerous gas 24 harmless inside the drip chamber. In other embodiments, the air outlet 72 further comprises a conduit (not shown) that vent the hazardous gas 24 from the drip chamber 40 directly into the first fluid reservoir 12. For example, in some embodiments, the coupling assembly 20 it may additionally include a parallel air channel (not shown) which is coupled to the first fluid reservoir 12. Furthermore, in some embodiments, the air outlet 72 comprises a conduit (not shown) that vent the hazardous gas 24 from the drip chamber 40 into a chemical cover (not shown) or other container to prevent unwanted exposure of the hazardous gas 24 to the environment.
    [048] Upon contact of the fluid 160 with the ventilation membrane 58, the flow of the fluid 160 is stopped, thus ending the flow of fluid through the membrane 66. Before removing the ventilation membrane 58, the flow regulator 52 can retain the charged state of patient conduit 50. This self-loading configuration provides efficient purging of air within the system without the need to manually move air bubbles through rapid movement or other manual manipulation of system components 10.
    [049] In some embodiments, the end 54 is configured so that by coupling a luer device to the end 54, the ventilation membrane 58 is automatically annulled, thus restarting the flow of fluid through the conduit. Referring to Figure 1C, a representative embodiment of a ventilation membrane activated by luer 158 is shown. Someone skilled in the art will appreciate that this modality represents only one of many methods and designs through which a luer-driven membrane can be provided. In general, end 54 comprises a plug 120 insertably coupled to an end of patient conduit 50. An opening between plug 120 and conduit 50 provides fluid communication between the two components. A flange portion 130 of the plug 120 is provided as a means for attaching a coupler (not shown) associated with a luer device (not shown). An internal cavity 140 of the plug 120 is configured to house the ventilation membrane 158 and the inclination means 152. In some embodiments, the inclination means 152 comprises a spiral spring or a perforated elastomeric material. In other embodiments, a portion of the membrane vent 158 is modified to provide a tilt function.
    [050] In some embodiments, a first end portion of cavity 140 comprises a retaining ridge 142 that has an inner diameter that is less than an outer diameter of the vent membrane 158. Cavity 140 further comprises a second portion of end having a stepped surface 144 to support the tilting means 152. In this way, the membrane 158 and the tilting means 152 are positioned interposed between the retaining ridge 142 and the stepped surface 144 within the cavity 140. As configured , the tilting means 152 positions the membrane 158 against the retention ridge 142, so that a seal 154 is formed between the membrane 158 and the retention ridge 142. In this way, during the loading process, the air within the system 10 is vented from the system 10 through the membrane 158, however, the physical properties of the membrane 158 and / or the seal 154 prevent the passage of fluids.
    [051] With reference to Figure 1D, the seal 154 is suspended by coupling the luer 170 device to the end 54. The luer 170 device can include any device that has a configuration capable of driving the membrane 158. In some embodiments, the device luer 170 comprises a body 172 that has a feature 174 for coupling to plug 120. The luer 170 device further comprises an internal cavity 182 in fluid communication with a downstream device, such as a catheter or catheter tube 210. The device luer 170 additionally comprises a probe portion 176 configured to partially insert into the plug 120 and come into contact with membrane 158. The contact between probe portion 176 and membrane 158, membrane 158 can be repositioned so that seal 154 be canceled. A plurality of holes or ports 178 located in the probe portion 176 provide fluid communication between the plug 120 and the internal cavity 182 of the luer device 170 so that the fluid is allowed to flow into the catheter tube 210.
    [052] Referring now to Figure 3, following the loading of the drip chamber 40 and the patient conduit 50, the spike-type connector 30 of the coupling assembly 20 is coupled to a first fluid reservoir 12. In some embodiments, the first fluid reservoir 12 is an intravenous bag containing a dangerous chemical or drug 16. In other embodiments, a first fluid reservoir 12 is an intravenous vial or other similar reservoir device. fluid reservoir 12 generally includes a septum 36, or perforable membrane through which the spike-type connector 30 is compatibly inserted. Once inserted, the flow regulator 52 is released and the hazardous drug 16 is allowed to flow through the coupling assembly 20, into the drip chamber 40 and into the patient conduit 50, as shown in Figure 4. those embodiments that incorporate a rigid or semi-rigid intravenous vial, a portion of the drip chamber 40 may additionally include an air outlet 74. In some embodiments, the air outlet 74 includes a filter designed to minimize the potential to pass the aerosolized or gas form 24 of the hazardous drugs within the intravenous delivery system 10, as the hazardous drug 16 moves through the system 10.
    [053] Referring now to Figure 4, following the infusion of the hazardous drug 16, a washing fluid 160 is added to the drip chamber 40 through the loading / self-sealing wash port 44. In some embodiments, the washing fluid 160 is identical to loading solution 160. In other embodiments, washing fluid 160 is a secondary non-hazardous drug. The washing fluid 160 presses the remaining dangerous drug 16 into the patient, thus ensuring the complete infusion of the medication 16. The infusion of the washing fluid 160 additionally acts to clean or decontaminate the catheter portion 102 of the intravenous delivery system. 10 of the residual dangerous drug 16. Once a sufficient volume of washing fluid 160 has been introduced, catheter 102 can safely be removed from the insertion site 106 without exposing the technician or patient 100 to the dangerous drug 16.
    [054] In some embodiments of the present invention, the intravenous delivery system 10 includes a coupling assembly 120 that has multiple fluid channels 60 and 70, as shown in Figure 5. As previously discussed, the first fluid channel 60 provides a fluid path between a coupled fluid reservoir 12 and a drip chamber 40 of the intravenous delivery system 10. In some embodiments, the first fluid channel 60 further comprises a second fluid channel 70 which provides a fluid path between a port self-sealing access port 26 and the coupled fluid reservoir 12. The second fluid channel 70 includes an inlet 34 and an outlet 38, the inlet 34 being coupled to an internal portion of the access port 26, and the outlet 38 is in fluid communication with fluid 160 of fluid reservoir 12. In some embodiments, the first fluid channel 60 and the second fluid channel 70 share a wall d common window 22 that crosses the length of both fluid channels 60 and 70. In some embodiments, the second fluid channel 70 is a tube (not shown) in which the walls of the tube divide the first fluid channel 60 of the second channel of fluid 70.
    [055] In some embodiments, the second fluid channel 70 additionally includes an access port 26. Access port 26 is coupled to an external surface of the coupling assembly 120 and is in fluid communication with the second fluid channel 70. The access port 26 is designed to compatiblely receive a syringe 80 or other delivery device configured to deliver a hazardous drug 16 to the fluid reservoir 12 via the second fluid channel 70. In some embodiments, the access port 26 is designed to irreversibly receive and retain a syringe 80. In other embodiments, access port 26 comprises a set of threads (not shown) configured to receive a compatible set of threads (not shown) located in a portion of the syringe 80. In other embodiments, the access port 26 and the syringe 80 are coupled together via a luer-lock coupling assembly.
    [056] Access port 26 generally includes an opening 90 for receiving a tip portion 82 of syringe 80. Access port 26 additionally includes a split valve or septum 84 that is opened by inserting tip 82 into opening 90 Prior to insertion of the tip portion 82, the septum 84 is oriented in a closed sealed configuration, thereby preventing leakage of the charging fluid 160 into the second fluid channel 70 through outlet 38. In some embodiments, the carrier fluid is the loading fluid 160 of the fluid reservoir 12. For those modalities where the tip portion 82 and opening 90 are reversibly coupled or reversibly interlocked by removing tip 82 from opening 90, the septum 84 resumes its closed sealed configuration, thereby preventing leakage of fluid from the second fluid channel 70.
    [057] In some embodiments of the present invention, the drip chamber 40 and patient conduit 50 are charged with a charging fluid 160 prior to the injection of the hazardous drug 16 through the access port 26. The system loading process 10 requires a tip portion 30 of coupling assembly 120 to be inserted first into the first fluid reservoir 12 that contains loading fluid 160. For those embodiments that are configured in a self-loading configuration, the loading fluid 160 of the first fluid reservoir 12 automatically flows into the drip chamber 40 and patient conduit 50, thereby providing a second fluid reservoir 42, as well as displacing the air within conduit 50.
    [058] In some embodiments, the system 10 is configured to exclude the ventilation membrane 58, and comprises only one membrane 66. For these modalities, the process of loading the system 10 comprises blocking the first patient duct 50 via the flow regulator 52 or similar fixing device. Following occlusion, the tip portion 30 of the coupling assembly 120 is inserted into the first fluid reservoir 12. A flexible portion 72 of the drip chamber 40 is then compressed or otherwise manipulated to extract fluid 160 from into the drip chamber 40 through the first fluid channel 60, as conventional. Once a second fluid reservoir 42 is formed, the flow regulator 52 is released and the charging fluid 160 resumes the flow from the first reservoir 12 and through patient conduit 50 to purge air into conduit 50.
    [059] In other embodiments, the system 10 is configured to exclude membrane 66, and comprises only a ventilation membrane 58. For these modalities, the process of loading system 10 comprises inserting the tip portion 30 of the coupling assembly 120 inside the first fluid reservoir 12 before obstructing the patient conduit 50 through a flow regulator 52. The charging fluid 160 flows freely from the first fluid reservoir 12 into the drip chamber 40 and the patient conduit 50. Once the charging fluid 160 reaches the ventilation membrane 58, the fluid flow ceases and the patient duct 50 is obstructed by the flow regulator 52. At this point, system 10 is completely charged with the fluid loading 160 which results in complete displacement and purging of air within patient duct 50. In some embodiments, the dust cover 56 and the adjacent ventilation membrane 58 are removed from the terminal end 54 of patient conduit 50, and patient conduit 50 is coupled to a secondary patient conduit (not shown) or coupled to an intravenous catheter 102, as shown in Figure 6.
    [060] Referring now to Figure 6, a dangerous drug 16 is injected into the first fluid reservoir 12 through access port 26 and a syringe 80. In some embodiments, a tip portion 82 of syringe 80 is inserted into an opening 90 of the access door 26, so that the tip portion 82 orients the septum 84 in an open position. The syringe 80 is then driven to deliver the hazardous drug 16 to the first fluid reservoir 12. The hazardous drug 16 and loading fluid 160 from the first fluid reservoir are mixed to provide a desired concentration of the dangerous drug 16 in the fluid. loading 160. Flow regulator 52 is then released to resume fluid flow 16 through system 10 and into patient 100 via coupled catheter 102.
    [061] In some embodiments, patient conduit 50 additionally includes a wash port 86. Wash port 86 generally comprises an adapter coupled to an external surface of patient conduit 50. Wash port 86 includes a configured opening 88 to compatiblely receive a tip portion 182 of a syringe 180. In some embodiments, opening 88 further comprises a septum 84 that can be oriented in an open position by inserting syringe tip portion 182 into opening 88. In in other embodiments, opening 88 additionally comprises a perforable membrane that is canceled in an open position by inserting syringe tip 182 into opening 88. Other embodiments of the flush port 86 include a valve or other device that allows a syringe 180 to access fluidly the patient conduit 50, as shown in Figure 7.
    [062] Referring now to Figure 7, the intravenous system is shown following the infusion of the dangerous drug 16. In some embodiments, a dangerous vapor 24 and the unused dangerous drug remain in the first fluid reservoir 12 following the procedure infusion. In other embodiments, syringe 80 and access port 26 are irreversibly interlocked to prevent removal of syringe 80 which results in unwanted exposure to the remaining dangerous drug 16. For those modalities that comprise an anti-sealing membrane 66, the drug dangerous 16 empties completely from the drip chamber 40, however, it does not drain beyond membrane 66. Preferably, the dangerous drug 16 remains within membrane 66 and prevents the introduction of air into patient conduit 50. As a result, flow of dangerous drug 16 through patient conduit 50 ceases resulting in patient conduit 50 which is loaded with dangerous drug 16. In addition, the inserted portion of catheter 102 remains contaminated with dangerous drug 16. Thus, in some embodiments, an outer surface of patient conduit 50 is modified to include a wash port 86. Wash port 86 is configured to receive a syringe 180 containing a loading or washing fluid 160 to wash catheter portion 102 of the intravenous delivery system 10 prior to removal of catheter 102 from patient 100 is compatible.
    [063] The process for washing patient conduit 50 through the wash port 86 requires first that patient conduit 50 is obstructed through flow regulator 52. In some embodiments, flow regulator 52 is positioned interposed with the along the outer surface of patient conduit 50 between drip chamber 40 and wash port 86. Once patient conduit 50 is obstructed, syringe 180 is inserted into opening 88 of wash port 86 to provide fluid communication between syringe 180 and fluid 16 within patient conduit 50. Syringe 180 is then actuated to inject and infuse wash fluid 160 into the patient through patient conduit 50 and catheter 102. In the process of infusing the washing fluid 160, the downstream portion of patient conduit 50, as well as the inserted portion of catheter 102 are completely washed with washing fluid 160. As such, the inserted portion of catheter 102 is decontaminated that of the dangerous drug 16 and can be safely removed without exposure to the dangerous drug 16. The intravenous delivery system 10, the attached syringes 80 and 180, and the remaining dangerous drug 16, then, can safely be disposed of without topical or inhaled exposure to the dangerous drug 16.
    [064] Several features of the present invention can be used in combination to provide an intravenous delivery system 10 to safely deliver a dangerous drug 16 to a patient 100. For example, with reference to Figure 8, an intravenous delivery system 10 is provided incorporating both a loading / flushing port 44 and an access port 26. In some embodiments, a coupling assembly 120 is provided having a first fluid channel 60 and a second fluid channel 70. The first fluid channel 60 provides fluid communication between the coupling assembly 120 and a connected drip chamber 40. In some embodiments, a tip portion 30 of the coupling assembly 120 is inserted into a fluid reservoir 12, such as an intravenous pouch or an intravenous vial . As such, the first fluid channel 60 of coupling assembly 120 provides a conduit to allow fluid 160 to flow from fluid reservoir 12 to drip chamber 40, as shown in Figure 9.
    [065] The second fluid channel 70 forms a portion of the coupling assembly 120 and generally passes parallel to the first fluid 60, as previously discussed. The second fluid channel 70 additionally comprises an access port 26 through which a fluid 16 is externally injected into the second fluid channel 70. In some embodiments, an opening or outlet 38 of the second fluid channel is located in the tip portion 30 of the coupling assembly 120. Thus, when the tip portion 30 of the coupling assembly 120 is inserted into a first fluid reservoir 12, a fluid 16 can be injected into the fluid reservoir 12 through the second fluid channel 70, as shown in Figure 10. In some embodiments, an opening 90 of the access port 26 is configured to receive a syringe 80 or other similar fluid application apparatus in a compatible manner. In other embodiments, opening 90 is modified to include a feature to reversibly interlock syringe 80 and access port 26. In addition, in some embodiments, opening 90 is modified to include a feature or features to receive and interlock in a manner syringe 80 and access port26 permanently.
    [066] In some embodiments, a portion of the drip chamber 40 is modified to include a loading / flushing port 44.The loading / flushing port 44 provides direct access to the drip chamber 40, as previously discussed in connection with the Figures 1-4 above. Thus, in some embodiments, the drip chamber 40 and patient conduit 50 are loaded with a loading solution 160 through a syringe 180 and the loading / washing port 44, as shown in Figure 8. In other embodiments, the drip chamber 40 and patient conduit 50 are loaded by inserting the tip portion 30 of the coupling assembly 120 into a first fluid reservoir 12 containing a loading fluid 160, as shown in Figure 9. For those embodiments implementing a ventilation membrane 58, the charging fluid 160 automatically flows into the drip chamber 40 and through the patient conduit 50 displacing the air present therein.
    [067] Following the loading procedures in Figures 8 and 9, patient conduit 50 is obstructed with a flow regulator 52, and a dangerous drug 16 is introduced into the first fluid reservoir 12 through the second fluid channel 70 and the access port 26, as shown in Figure 10. Generally, a tip portion of syringe 80 is inserted into opening 90 of access port 26 to induce septum opening 84 and initiate fluid communication between syringe 80 and the second channel of fluid 70. The highly concentrated dangerous drug 16 into syringe 80 is then injected into the first fluid reservoir 21 through the second fluid channel 70. The dangerous drug 16 is then mixed with the loading fluid 160 of the first fluid reservoir 12 to provide a hazardous drug solution 16 in a desired concentration. The flow regulator 52 is then released to allow the diluted hazardous drug 16 to flow into the drip chamber 40 and patient conduit 50. In some embodiments, the ventilation membrane 58 and the dust cover 56 are replaced with a intravenous catheter 102 to allow intravenous infusion of the dangerous drug 16 into a patient 100.
    [068] Following the infusion procedure of Figure 10, the remaining dangerous drug 16 inside the drip chamber 40 and patient conduit 50 is flushed into patient 100 by adding a washing fluid 160 to the drip chamber through of the loading / flushing port 44, as shown in Figure 11. In some embodiments, flushing fluid 160 is the same as loading fluid 160 in Figure 9. In other embodiments, flushing fluid 160 is a secondary non-hazardous drug. As the flushing fluid 160 flows through the drip chamber 40, patient conduit 50 and catheter 102, residual hazardous drug 16 is infused into patient 100. In addition, components 40, 50 and 102 are decontaminated of the dangerous drug 16 thus allowing the safe removal of catheter 102 from patient 100 without the possibility of topical or inhaled exposure to drug 16 or dangerous vapor 24. Following the removal of catheter 102, the intravenous delivery system 10, the drug residual 16 and coupled syringes 80 and 180 are suitably arranged.
    [069] In some embodiments of the present invention, the intravenous application includes neither an anti-sealing membrane 66 nor a ventilation membrane 58. For these modalities, a clinician initiates the flow from the fluid reservoir 12 by compressing a portion 72 of the drip chamber 40, as conventional. In other embodiments, the drip chamber 40 and patient conduit 50 are preloaded from the manufacturer with a charging fluid 160. Before connecting coupling assembly 20 or 120 to the first fluid reservoir 12, the conduit patient 50 is obstructed via a regulator 52. A dangerous drug 16 is then injected into the fluid reservoir 12 through the access port 26, and the flow is initiated through the system 10 releasing the regulator 52. In some embodiments , regulator 12 is selectively adjustable to allow a desired flow rate through patient conduit 50. In other embodiments, the drug-trace 16 that remains in the second fluid channel 70 is discharged into the first fluid reservoir 12 by repeatedly actuating the syringe 80.
    [070] A common practice is to pre-inject a fluid reservoir 12 with a dangerous drug 16 before application to a clinician. Pre-injection of the dangerous drug 16 is commonly performed by a pharmacist or other technician under a chemical cover or in a well-ventilated area. Pre-injection eliminates the need for a clinician to handle the highly concentrated dangerous drug, and additionally ensures proper dosing. The pre-injected reservoir is applied to the clinician for administration to the patient. Some embodiments of the present invention are used in conjunction with pre-injected reservoirs, as well as with multiple fluid reservoirs or connected in series.
    [071] In some embodiments, the second fluid channel 70 is used to vent a dangerous vapor 24 into the first fluid reservoir 12, as shown in Figure 12. For example, in some embodiments, the air within patient conduit 50 is purged by loading conduit 50 directly with the hazardous drug 16 from a pre-injected fluid reservoir 12. As the hazardous drug 16 exits the drip chamber 40 and proceeds through patient conduit 50, the hazardous vapor 24 of the hazardous drug 16 is pressed through conduit 50. While the flow restriction device 58 prevents the liquid hazardous drug 16 from escaping from conduit 16, device 58 is doubly designed to readily allow the passage of dangerous vapor 24. Thus, during the loading process the clinician may be undesirably exposed to dangerous vapor 24.
    [072] Therefore, in some embodiments of the present invention, the terminal end 54 of patient conduit 50 is inserted in a compatible manner in the access port 26 before loading the intravenous set 10 with the dangerous drug 16. Once the terminal end is coupled to the access port 26, the flow regulator 52 is released to initiate the flow of the hazardous drug 16 into the drip chamber 40. As the hazardous drug 16 moves through patient conduit 50, the hazardous vapor 24 is moved from the conduit 50 and into the fluid reservoir 12 through the second fluid channel 70. In this way, the patient conduit 50 is purged of the captured air, and the dangerous vapor 24 from the dangerous drug 16 is gassed within the fluid reservoir 12 and contained in system 10. This loading process ensures complete loading while preventing unsafe exposure of dangerous drug 16 and vapors 24 to the clinician.
    [073] Following the loading process, conduit 50 is again blocked with flow regulator 52 and the end end 54 is removed from access port 26. The clinician can then remove the dust cover 56 and the dust membrane. ventilation 58 to allow fixation of conduit 50 in a patient 100 via catheter 102. In some embodiments, the dust cover 56 additionally comprises a valve device by means of which catheter 102 is coupled directly and fluidly to the conduit of patient 50 without removing the dust cover 56 or ventilation membrane 58. In other embodiments, the ventilation membrane 58 is capable of being pierced by a portion of an intravenous catheter 102, through which intravenous catheter 102 is coupled direct and fluid way to patient conduit 50 without removing the flow control device 58. As such, the clinician can securely connect patient conduit 50 to patient 100 without being exposed to the drug the dangerous 16 within the patient conduit 50. Furthermore, in some embodiments, the patient conduit 50 additionally comprises a flush port 86 through which the end end 54 and the coupled catheter 102 of the system 10 are discharged with a fluid from wash 116 before removal of patient 100.
    [074] Referring now to Figure 13, an implementation of the present invention is shown during the process of loading patient conduit 50 with a dangerous drug 16. In some embodiments, the end end 54 of patient conduit 50 is coupled to a container 94 configured to receive and contain dangerous steam 24 displaced from the conduit 50 during the loading process. Container 94 can include any device or system capable of preventing undesirable exposure to hazardous vapor 24. For example, in some embodiments, container 94 is a tank. In other embodiments, container 94 is a ventilation hood or a ventilation system. In other modalities, container 94 is a disposable bag or balloon.
    [075] In some embodiments, container 94 additionally comprises neutralizing agents or catalysts that sequester or otherwise interact with vapor 24 to reduce its hazard. In other embodiments, the cap 56 or ventilation membrane 58 is additionally modified to allow attachment of the terminal end to a patient 100 through a catheter 100, or other device without exposing the clinician to dangerous vapor 24 or dangerous drug 16 within the conduit 50. In addition, some drip chambers 40 of the present invention include a loading / flushing port 44 through which dangerous drug 16 within patient conduit 50 and coupled catheter 102 is discharged prior to removal from patient 100 following the infusion procedure.
    [076] Referring now to Figure 14, an intravenous primary set 200 is combined with an intravenous secondary set 300 to provide a hazardous drug 16 to a patient 100 through patient conduit 50. In this embodiment, the secondary set intravenous 300 is coupled to the primary intravenous set 200 via an in-line access port 202. The in-line access port 202 allows a hazardous drug 16 from the second intravenous set 300 to flow into patient conduit 50 and into the patient 100. In some embodiments, the conduit line 150 of the second intravenous set 300 includes a closed luer tip 302 that automatically opens the fluid path by fixing the luer tip 302 to the line access port 202. In addition, by means of removal of the luer tip 302 from the line access port 202, the fluid path is closed and the luer tip 302 is cleaned by the flow of the charging fluid 160 through the cond patient uto 50. In some embodiments, the in-line access door 202 includes a set of threads for receiving a turning nut on the luer tip 302. For these embodiments, the luer tip 302 is opened by tightening the lock nut to the around the set of threads, and is closed as the lock nut is loosened from the set of threads. In other embodiments, a proximal portion of the inline access door 202 is used to open and close the luer tip 302 in full or almost total engagement. In addition, in some embodiments, the luer tip 302 includes a manual key or valve to open and closing the fluid flow through the luer tip 302.
    [077] Following the infusion of the hazardous drug 16, a flow regulator 52 of the second intravenous set 300 is actuated to obstruct the conduit line 150 of the second intravenous set 300. The flow regulator 52 of patient conduit 50, then, is released to allow loading fluid 160 to flow through patient conduit 50 and wash the remaining dangerous drug 16 into patient 100. In some embodiments, a portion of the luer tip 302 is positioned in the flow path of the patient conduit 50, so that the luer tip 302 is free of the hazardous drug 16 via the loading fluid 160. In other embodiments, the online access port 202 includes a dead space that retains trace amounts of the hazardous drug 16 following the infusion. Therefore, in some embodiments, a flush port 86 is incorporated into the conduit line 150 of the second intravenous set 300. The flush port 86 is accessed by a syringe to inject loading fluid 160 through a distal portion of the conduit line 150. In this way, the washing port 86 allows the dead space of the online access door 202 to be sufficiently discharged from the remaining dangerous drug 16. Following the complete washing of the dangerous drug from the online access door 202 and the patient conduit 50 , catheter 102 can be safely removed from patient 100 without exposure to the dangerous drug 16. In addition, in some embodiments, the online access port 202 is a zero dead space connector. For example, in some embodiments, a zero dead space connector eliminates the dead space between the flow path of patient conduit 50 and luer tip 302.
    [078] The present invention can be incorporated in other specific forms without leaving its structures, methods or other essential characteristics, as widely described in the present document and later claimed in the present document. Thus, the modalities described should be considered in all aspects only as illustrative and not restrictive. For example, some embodiments of the present invention can be used in conjunction with an intravenous pump. Other embodiments of the present invention can be configured to exclude the use of a drip chamber or a flow measurement device, such as a flow regulator or a dial-flow. The scope of the invention, therefore, is indicated by the appended claims, rather than the preceding description. All changes that arise within the meaning and equivalence range of the claims must be adopted within their scope.
    权利要求:
    Claims (16)
    [0001]
    1. Closed intravenous solution application system (10) for intravenous application of a dangerous solution (16), the system (10) FEATURED by the fact that it comprises: a coupling set (20, 120) having an inlet (62) and an outlet (64), the inlet (62) configured to couple with a primary fluid reservoir (12) to provide a flow of fluid from the primary fluid reservoir (12) to the outlet (64) ; a drip chamber (40) having an inlet (46) and an outlet (48), the inlet (46) of the drip chamber (40) coupled directly to the outlet (64) of the coupling assembly (20, 120) to receive the fluid from the fluid flow from the primary fluid reservoir (12) to form a secondary fluid reservoir (42) within the drip chamber (40), the outlet (48) of the drip chamber (40) being configured to receiving a patient conduit (50), where the coupling between the inlet (62) of the coupling assembly (20, 120) and the primary fluid reservoir (12) prevents ventilation between the drip chamber (40) and a external environment; a loading port (44) in direct fluid communication with the gouging chamber (40), the loading port (44) having a self-sealing valve, thus preventing ventilation between the drip chamber (40) and the external environment; and a membrane (66) disposed within the drip chamber (40) and positioned interposed between the secondary fluid reservoir (42) and the outlet (48) of the drip chamber (40), in which, once wet, the membrane (66) prevents the passage of air from the drip chamber (40) to the outlet (48) of the drip chamber (40), thus preventing ventilation between the drip chamber (40) and the external environment.
    [0002]
    2. System (10), according to claim 1, CHARACTERIZED by the fact that the self-sealing valve is a dividing septum (84, 184).
    [0003]
    3.System (10), according to claim 1, CHARACTERIZED by the fact that the loading port (44) is in direct fluid communication with the drip chamber (40).
    [0004]
    4.System (10) according to claim 1, CHARACTERIZED by the fact that the loading port (44) is configured to deliver a loading solution (160) to the secondary fluid reservoir (42).
    [0005]
    5. System (10), according to claim 1, CHARACTERIZED by the fact that the patient conduit (50) comprises: a first end coupled to the outlet (48) of the drip chamber (40); and a second end (54) that supports a flow control plug (58) configured to control the flow of air and fluid through the patient conduit (50).
    [0006]
    6. System (10), according to claim 3, CHARACTERIZED by the fact that the loading port (44) is configured to selectively receive a syringe (80, 180) and in which an interaction between the syringe (80, 180 ) and the loading port (44) prevents ventilation between the drip chamber (40) and the external environment.
    [0007]
    7. The system (10) according to claim 3, CHARACTERIZED by the fact that the loading port (44) comprises a one-way valve configured to allow the flow of the loading solution (160) directly into the drip chamber ( 40) while preventing ventilation between the drip chamber (40) and the external environment.
    [0008]
    8. Closed intravenous solution application system (10) for intravenous application of a dangerous solution (16), the system (10) CHARACTERIZED by the fact that it comprises: a coupling set (20, 120) having a first fluid channel (60) and a second fluid channel (70), the first fluid channel (60) having an inlet (62) and an outlet (64), the inlet (62) being configured to couple with a primary fluid reservoir (12) to provide the flow of a fluid from the primary fluid reservoir (12) to the outlet (64), and the second fluid channel (70) having fluidly interconnected the first and second ends (54), the first end being in fluid communication with the primary fluid reservoir (12), and a second end (54) being in fluid communication with an access port (26); the access door (26) having a self-sealing valve, thus preventing ventilation between the primary fluid reservoir (12) and an external environment; a drip chamber (40) having an inlet (46) and an outlet (48), the inlet (46) of the drip chamber (40) being directly coupled to the outlet (64) of the coupling assembly (20, 120) a in order to receive the fluid directly from the primary fluid reservoir (12) and form a secondary fluid reservoir (42) within the drip chamber (40), the drip chamber (40) additionally including a loading port (44 ) positioned adjacent to the secondary fluid reservoir (42) and in direct fluid communication with the primary fluid reservoir (12), the loading port (44) having a self-sealing valve, thus preventing ventilation between the drip chamber and (40) and the external environment, the outlet (48) of the drip chamber (40) being configured to receive a patient conduit (50) in which the coupling between the inlet (62) of the coupling set (20, 120 ) and the primary fluid reservoir (12) prevents ventilation between the drop chamber flow (40) and the external environment; and a membrane (66) disposed within the drip chamber (40) and positioned interposed between the secondary fluid reservoir (42) and the outlet (48) of the drip chamber (40), in which, once wet, the membrane (66) prevents the passage of air from the drip chamber (40) to the outlet (48) of the drip chamber (40) thus preventing ventilation between the drip chamber (40) and the external environment.
    [0009]
    9. System (10) according to claim 8, CHARACTERIZED by the fact that the self-sealing valve of at least one of the access port (26) and the loading port (44) is a dividing septum (84 , 184).
    [0010]
    10. System (10), according to claim 8, CHARACTERIZED by the fact that the access door (26) is configured to receive a dangerous solution (16) and apply the dangerous solution (16) directly to the primary fluid reservoir (12) without venting the hazardous solution (16) to the external environment.
    [0011]
    11. System (10), according to claim 8, CHARACTERIZED by the fact that the loading port (44) is configured to receive a loading solution (160) and deliver the loading solution (160) directly to the storage tank secondary fluid (42) without venting the hazardous solution (16) to the external environment.
    [0012]
    12. System (10), according to claim 8, CHARACTERIZED by the fact that the patient conduit (50) comprises: a first end coupled directly to the outlet (48) of the drip chamber (40); and a second end (54) that supports a flow control plug (58) configured to control the flow of air and fluid through the patient conduit (50) thereby preventing ventilation between the drip chamber (40) and the environment external.
    [0013]
    13. System (10), according to claim 8, CHARACTERIZED by the fact that the access port (26) is configured to selectively receive a syringe (80, 180) and in which an interaction between the syringe (80, 180 ) and the access door (26) prevents ventilation between the primary fluid reservoir (12) and the external environment.
    [0014]
    14. System (10), according to claim 8, CHARACTERIZED by the fact that the self-sealing valve of the access port (26) allows the flow of the dangerous solution (16) from an injection device into the reservoir of primary fluid (12) without venting the hazardous solution (16) to the external environment.
    [0015]
    15. The system (10) according to claim 8, CHARACTERIZED by the fact that the loading port (44) is configured to selectively receive a syringe (80, 180), and in which an interaction between the syringe (80, 180) and the loading port (44) prevents ventilation between the drip chamber (40) and the external environment.
    [0016]
    16. System (10), according to claim 8, CHARACTERIZED by the fact that the self-selling valve of the loading port (44) allows the flow of the loading solution (160) directly into the drip chamber (40) ) without venting the hazardous solution (16) to the external environment.
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    法律状态:
    2018-12-26| B06F| Objections, documents and/or translations needed after an examination request according art. 34 industrial property law|
    2019-08-27| B06U| Preliminary requirement: requests with searches performed by other patent offices: suspension of the patent application procedure|
    2020-06-16| B06A| Notification to applicant to reply to the report for non-patentability or inadequacy of the application according art. 36 industrial patent law|
    2020-10-20| B09A| Decision: intention to grant|
    2020-12-08| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 14/04/2011, OBSERVADAS AS CONDICOES LEGAIS. |
    优先权:
    申请号 | 申请日 | 专利标题
    US12/775,128|US8366658B2|2010-05-06|2010-05-06|Systems and methods for providing a closed venting hazardous drug IV set|
    US12/775,128|2010-05-06|
    PCT/US2011/032487|WO2011139514A1|2010-05-06|2011-04-14|Systems and methods for providing a closed venting hazardous drug iv set|
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