巴西专利BR112012027441B1 device to safely administer hazardous material to a patient

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专利摘要:
SYSTEMS AND METHODS FOR SUPPLYING A CLOSED VENTILATION HAZARDOUS DRUG SET IV. A device for the preparation and ventilation of a dangerous drug within an IV administration set (10). The device includes multiple access ports (42, 26, 86) and fluid channels (50, 150) to allow direct injection of a dangerous drug into the fluid reservoir (24), while eliminating the possibility of undesirable exposure to the drug dangerous. The device additionally includes preparation and washing ports to allow the washing of a dangerous drug from the system after an infusion process.
公开号:BR112012027441B1
申请号:R112012027441-4
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:

Fundamentals of the Invention
[001] The present invention relates to systems and methods for the preparation of an intravenous (IV) administration set with a dangerous drug or chemical, as commonly used in the fields of medical therapy or by infusion.
[002] An IV administration set is typically used to deliver to or recover from a patient a fluid, such as blood, a medication, a nutritional supplement, or a solution. In some areas of medicine, the treatment of diseases requires the infusion of dangerous chemicals such as toxic chemotherapeutic agents. Dangerous drugs are typically added to a fluid reservoir, such as an IV pouch, and then administered to the patient via the patient line and an intravenous needle. Before administering the hazardous solution to the patient, air from inside the patient's conduit must be purged to prevent infusion of air into the patient.
[003] Standard preparation procedures result in squeezing a portion of the IV delivery set drip chamber to initiate the flow of the dangerous drug from the fluid reservoir. Once the flow is initiated, the dangerous drug continues through the patient's conduit, thereby displacing the air within the conduit. However, in addition to the displacement of 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 illness, dizziness, nausea, vomiting, attacks, unconsciousness and even death. In addition, the physician must carefully monitor the preparation process to ensure that the dangerous 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, while techniques currently exist that are used to prepare an IV administration set for use with a dangerous drug, the challenges still exist. In this way, it would be an improvement in the technique if it increases or even replaces 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 the preparation of an IV administration set with a dangerous drug or chemical. Specifically, the present invention relates to an IV delivery system incorporating several fluid inlets and channels designed to minimize exposure to a dangerous drug or vapor within the IV delivery system.
[006] The IV delivery system usually includes a coupling assembly for attaching a drip chamber to a fluid reservoir, such as an IV pouch. In some embodiments, the coupling assembly includes a first fluid channel providing fluid communication between the fluid reservoir and the drip chamber of the dispensing system. In other embodiments, the coupling assembly additionally includes a second fluid channel providing fluid communication between the fluid reservoir and an external access port. The external access inlet 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 ring to deliver a dangerous drug to the fluid reservoir through the second fluid channel. In other embodiments, the access inlet additionally includes a valve or membrane to seal the second fluid channel.
[007] The set IV additionally includes a drip chamber fixedly attached to an outlet of the first fluid channel. The drip chamber usually 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 preparation inlet. The preparation inlet is coupled to an external surface of the drip chamber, and is in fluid communication with it. In some embodiments, a preparation solution may be useful in preparing a patient's conduit prior to infusion, or it may be useful in flushing the patient's conduit to remove the residual dangerous drug after the infusion procedure.
[008] In other implementations of the present invention, the drip chamber and patient conduit of the IV administration set are prepared with the dangerous drug contained within the fluid reservoir. In some embodiments, undesirable exposure to the dangerous drug during the preparation process is prevented by inserting a terminal end of the patient conduit into the coupling assembly access entrance. In this way, as the patient duct is prepared, dangerous vapors are vented into the fluid reservoir through the access inlet. In this way, exposure to dangerous molecules is avoided.
[009] In some embodiments of the present invention, the dangerous residual drug within the IV delivery system is flushed out of the system through a flush entry. The wash inlet is usually positioned on an external surface of the IV delivery system upstream of the patient's infusion site. In some embodiments, a syringe or other delivery device is coupled to the flushing port to deliver a preparation or flushing fluid into the IV delivery system. As such, the preparation fluid washes the hazardous drug residual from the delivery system and into the patient. Additionally, in some embodiments, unwanted exposure to the dangerous drug is prevented by inserting the terminal end of the patient's conduit into a container, or a filtering system during the preparation process. Brief Description of Various Views of Drawings
[0010] In order that the manner in which the characteristics and advantages mentioned above and other characteristics and advantages of the invention are obtained will be readily understood, a more particular description of the invention briefly described above will be created by reference to the specific modalities that are illustrated in the attached drawings. These drawings show only typical modalities of the invention and should therefore not be considered as limiting the scope of the invention.
[0011] Figure 1A is a perspective view of an implementation of a set IV having a preparation entry;
[0012] Figure 1B is a perspective view of an implementation of a ventilation cap according to a representative embodiment of the present invention;
[0013] Figure 1C is a cross-sectional view of an end end of an assembly IV incorporating a ventilation membrane according to a representative embodiment of the present invention;
[0014] Figure 1D is a cross-sectional view of an end end of an IV assembly incorporating a ventilation membrane coupled to a Luer device according to a representative embodiment of the present invention;
[0015] Figure 2 is a cross-sectional view of an implementation of a set IV of the present invention being prepared with a preparation solution through the preparation entrance;
[0016] Figure 3 is a cross-sectional view of an implementation of an IV set of the present invention coupled to an IV pouch;
[0017] Figure 4 is a cross-sectional view of an implementation of a set IV of the present invention being washed with a preparation solution through the preparation port, after the infusion of a dangerous drug;
[0018] Figure 5 is a cross-sectional view of an implementation of a set IV of the present invention, where set IV is coupled to a pocket IV and includes an access entrance;
[0019] Figure 6 is a cross-sectional view of an implementation of an IV set of the present invention where the IV pouch is injected with a hazardous drug through an access port;
[0020] Figure 7 is a cross-sectional view of an implementation of an IV set of the present invention where a part of a patient conduit is flushed with a preparation fluid through the wash inlet;
[0021] Figure 8 is a cross-sectional view of an implementation of a set IV of the present invention having a preparation entrance and an access entrance;
[0022] Figure 9 is a cross-sectional view of an implementation of a set IV of the present invention in a prepared state;
[0023] Figure 10 is a cross-sectional view of an implementation of an IV set of the present invention after the injection of a dangerous drug into an IV pouch through an access port;
[0024] Figure 11 is a cross-sectional view of an implementation of a set IV of the present invention following the infusion of a dangerous drug in a patient, where set IV is being washed with a preparation fluid through a preparation port;
[0025] Figure 12 is a cross-sectional view of an implementation of a set IV of the present invention in a closed ventilation configuration;
[0026] Figure 13 is a cross-sectional view of an implementation of an assembly IV of the present invention illustrated by venting a dangerous vapor into a detached container;
[0027] Figure 14 is a cross-sectional view of an implementation of an IV set of the present invention used in conjunction with a primary IV distribution set. Detailed Description of the Invention
[0028] The currently preferred embodiments of the present invention will be better understood by reference to the drawings, in which similar numerical references indicate identical or functionally similar elements. It will be readily understood that the components of the present invention, as generally described and illustrated in the figures presented here, can be arranged and designed in a wide variety of different configurations. Thus, the following more detailed description, as represented in the figures, should not limit the scope of the invention as claimed, but is merely representative of the currently preferred embodiments of the invention.
[0029] With reference now to figure 1, an implementation of an IV 10 distribution system is illustrated. Some embodiments of the IV 10 delivery system include a coupling assembly 20 having a pin 30 configured for insertion into a fluid reservoir 12, as shown in figure 3. Some implementations of the coupling assembly 20 comprise a rigid polymeric material such as polystyrene , polyester, or polypropylene. Some modes of the pin element 30 additionally include a beveled end surface 32 to assist insertion of the coupling assembly 20 into a fluid reservoir 12.
[0030] 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 distribution system. 10. The first fluid channel 60 includes an inlet 62 and an outlet 64. Referring to figure 3, inlet 62 is positioned within fluid reservoir 12, and outlet 64 is coupled to an inlet 46 of the drip 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, the outlet 64 additionally includes a tapered opening which allows fluid 16 to form in drops 18 before being collected in the drip chamber 40.
[0031] The drip chamber 40 is generally configured to receive fluid 16 delivered 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 as that fluid 16 leaves outlet 64. In some embodiments, the drip chamber 40 is generally cylindrical having a rigid upper part 71 sealed to a lower flexible part 72. In some embodiments, manipulation of the flexible part 72 of the chamber trickle 40 initiates the flow of a dangerous fluid or drug 16 from the fluid reservoir 12 into the drip chamber 40. This process requires the system 10 to be sealed first by inserting the pin 30 into a sealed fluid reservoir 12, and obstructing a patient's conduit 50 through a cylindrical clamp 52, or similar fixation device. A vacuum is created in the gutter chamber 40 by compressing and releasing the flexible part 72 of the drip chamber 40. This compression displaces the air inside the drip chamber 40 into the fluid reservoir 12, thus creating a negative pressure or vacuum inside the drip chamber 40. The negative pressure in the drip chamber pulls the dangerous drug 16 from the fluid reservoir 12 into the fluid reservoir 40 to form a second fluid reservoir 42 within the drip chamber drip 40, as is conventional. Once the cylindrical fastener 52 is released, the dangerous fluid 16 continues to flow from the fluid reservoir 12 due to the action of gravity. Those skilled in the art will appreciate that other methods can be used to initiate the flow of hazardous fluid 16 through the system, including gravity feeding methods or methods using a peristaltic pump.
[0032] Referring again to figure 1, some embodiments of the present invention additionally include an automatic washing / preparation inlet 44. The washing / preparation inlet 44 is coupled to an external surface of the drip chamber 40. In in some embodiments, the wash / prepare inlet 44 is positioned above the second fluid reservoir 42. In other embodiments, the wash / prepare inlet 44 is positioned adjacent to or within the second fluid reservoir 41 of the drip chamber 40 The wash / brew inlet 44 is in fluid communication with the inside of the drip chamber 40 and is designed to receive a syringe 180 or other device configured to deliver a wash / brew solution 160 directly to the brew chamber. drip 40. In some embodiments, the wash / preparation inlet 44 includes an opening 190 for receiving a tip portion 182 of a syringe 180. The wash / preparation inlet 4 4 additionally includes a divided valve or membrane 184 which is oriented to an open position by inserting tip 182 into opening 190. Prior to insertion of tip portion 182, valve or membrane 184 forms an impermeable seal, thereby maintaining pressure inside the drip chamber 40 and the rest of the IV 10 distribution system.
[0033] In some embodiments, the drip chamber 40 and patient conduit 50 are pre-prepared with a preparation solution 160 through the wash / preparation inlet 44. Referring now to figure 2, the drip chamber 40 is accessed through the wash / preparation port 44 with a syringe 180 containing a preparation fluid 160. In some embodiments, the preparation fluid 160 is a sterile solution of water containing a non-hazardous additive, such as sodium chloride or dextrose. The process of preparing the drip chamber 40 and patient conduit 50 purges air from these components, thereby preventing the possibility of air being infused into a patient during the infusion process.
[0034] In some embodiments, the IV 10 delivery system additionally includes a membrane 66 disposed in the drip chamber 40. The membrane 66 is configured so that air is prevented from leaving the drip chamber 40 inside of the patient's conduit 50. In this way, the membrane 66 acts as a bubble trap to trap any air bubbles that might otherwise flow out of the drip chamber 40 and into the patient conduit 50. As illustrated in figures 1 to 3, the drip chamber 40 is connected to a patient conduit 50. The conduit 50 comprises a tube used to carry the fluid 160 from the drip chamber 40 and the first fluid reservoir 12 for patient 100.
[0035] The membrane 66 is positioned at the bottom of the drip chamber 40 so as to completely cover the outlet of the drip chamber 48. By positioning the membrane 66 to completely cover the outlet of the chamber 48, air is prevented from being trapped between membrane 66 and outlet 48 as preparation fluid 160 moves through membrane 66. In addition, in some embodiments, membrane 66 comprises a hydrophilic material that is configured to interact strongly with fluid 16 thereby trapping the fluid 160 within the membrane 66. In some embodiments, the membrane 66 comprises at least one of polytetrafluoroethylene, hydrophilic nylon, hydrophilic polypropylene, hydrophilic polyethersulfone or a non-woven material coated with the above materials. As the fluid 160 flows from the drip chamber 40 through the membrane 66, the fluid 160 trapped within the membrane 66 is displaced by the incoming fluid 160, and the displaced fluid 160 is forced into the patient's conduit 50. However, when the drip chamber 40 dries, or when the supply of fluid 160 from the drip chamber 40 is 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's conduit 50.
[0036] In some embodiments, a cylindrical fastener 52, or other fixation device, in addition to a flow control plug or ventilation membrane 58 can also be attached to patient conduit 50. For example, in some embodiments the membrane 58 is coupled to the patient conductor 50 via a coupling device, such as a Luer connector or a friction interface. Clamp 52 allows the flow of fluid 160 out of the drip chamber 40 to be controlled or stopped. In some embodiments, the fastener is pre-programmed to allow fluid 160 to flow at a specific rate. In other embodiments, the clamp 52 is used in combination with a pump or other device (not shown) configured to limit the flow rate of the fluid 160.
[0037] 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 coupled directly to the terminal end 54 of the intravenous tubing 50. In other embodiments, the end 54 is configured to include a recess or other accessory for receiving the vent membrane 58, such as a wrap. . In other embodiments, a dust cover 56 is modified to include a ventilation membrane 58, as shown in figure 1B. The dust cap 56 may also include a plurality of vents 110 configured to retain the membrane 58, but allow air to pass through the membrane 58.
[0038] The ventilation membrane 58 can be configured to provide cervical functions as required by the IV 10 delivery system. For example, in some embodiments the ventilation membrane 58 is provided as a contaminant filter to protect the end 54 from contaminants external. In other embodiments, the ventilation membrane 58 is provided as a hydrophobic air filter configured to allow air ventilation within the distribution system, but to prevent the passage of fluids 160.
[0039] In some embodiments, the ventilation membrane 58 comprises a porous material, such as polytetrafluoroethylene, having a plurality of pores sized and configured to allow the passage of air, but 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 sized approximately from 0.1 to 0.5 microns, thus allowing air to pass through the pores, but preventing the passage of fluids and larger aerosol particles or molecules of dangerous drugs into the system 10. Thus, during the process of preparing the system 10, the air inside the patient's conduit 50 can escape from the conduit 50 through the ventilation membrane 58 while the fluid 160 and the hazardous gases 24 are retained in conduit 50. After the preparation process, fastener 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 IV line (not illustrated).
[0040] In some embodiments, the ventilation membrane 58 comprises a 360 membrane that is designed to minimize the potential for the passage of the aerosol or gaseous form of dangerous drugs that come in contact with the plug 58 during the preparation process. The ventilation membrane 58 is therefore configured to allow non-toxic air to pass into the patient's conduit 50, but includes structural or chemical characteristics to restrict the passage of larger toxic molecules. These features can include any technology or device capable of providing such restrictions.
[0041] For example, in some embodiments, the ventilation membrane material 58 comprises at least one of polytetrafluoroethylene, hydrophilic nylon, hydrophilic polypropylene, hydrophilic polyethersulfone, or a non-woven material coated with the above materials. Ventilation membrane 58 further includes restricted porosity, as discussed above, thereby limiting the passage of larger molecules. In other embodiments, the ventilation membrane 58 comprises a catalyst, such as activated carbon, which attaches to the dangerous drug molecules, thereby sequestering the dangerous molecules into the plug 58. In other embodiments, the ventilation membrane 58 comprises a compound of alternating layers of PTFE and carbon or activated carbon.
[0042] The flow rate of a fluid 160 through the conduit 50 is determined by the rate at which the air within the conduit can flow through the vent membrane 58. In this way, the flow of fluid 160 through the conduit 50 can be adjusted by increasing or reducing the number and size of plug pores 58. For example, in some embodiments, the flow rate of the ventilation membrane 58 is increased by increasing the diameter of the pores, or by increasing the number of pores. In another embodiment, the flow rate of the ventilation membrane 58 is reduced by reducing the pore diameter, or by reducing the number of pores.
[0043] In some embodiments, the rate of air flow through the vent membrane 58 is set 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 an adequate free bubble flow of the fluid 160 through the system 10. In some embodiments, the flow rates 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 less than the rate at which air is vented through ventilation membrane 58. As such, fluid 160 forms a puddle 76 in the second reservoir of fluid 42, as illustrated in figures 2 to 4.
[0044] The puddle 76 of fluid 160 provides a continuous bubble-free fluid source that flows from the drip chamber 40 and through the conduit 50 displacing the trapped air there. In other embodiments, the flow rate of the ventilation membrane 58 is configured to be less than the flow rate of the membrane 66 so that the flow rate of the fluid 160 through the duct 50 is reduced to a rate ideal flow. In some embodiments, an ideal flow rate is the rate at which fluid 160 will efficiently and completely displace air within conduit 50 during the preparation process.
[0045] In these modalities that are configured to incorporate a membrane 66 and a ventilation membrane 58, the system 10 preparation process does not require the use of cylindrical fastener 52, or any similar fixation device as is conventional. Instead, the combination of membrane 66 and ventilation membrane 58 allows automatic preparation of system 10. Specifically, since preparation fluid 160 is introduced into drip chamber 40, fluid 160 automatically flows through the membrane 66 and duct 50 until ventilation membrane 58 is reached. In some embodiments, the drip chamber 40 additionally includes a vent 74 where a negative pressure within the drip chamber 40 is equalized to allow automatic fluid flow 160 through membrane 66.
[0046] The position of the ventilation 72 in the drip chamber 40 is selected in order to determine the height of the second fluid reservoir 42. This way, as the fluid 16 flows into the drip chamber 40, the height of the fluid 16 is prevented from exceeding the positioned height of the vent 72. When the height of the second fluid reservoir 42 exceeds the positioned height of the vent 72, the vent 72 is blocked by the fluid 16 and is thus prevented to vent and / or equalize the pressure inside the drip chamber 40. As such, positive pressure builds up inside the drip chamber 40 preventing fluid from flowing from the first fluid reservoir 12. As fluid 16 is released or flows into the patient duct 50, the height of the second reservoir of fluid 42 is returned to a position lower than the height of the ventilation 72, thus allowing ventilation 72 to release the positive pressure within the drip chamber 40. As q When the pressure inside the drip chamber 40 equalizes, the fluid flow from the first reservoir 12 is resumed.
[0047] In some embodiments, the ventilation 72 additionally comprises a filter (not shown) that is configured to trap or render the dangerous gas 24 into a harmless aerosol inside the drip chamber. In other embodiments, the vent 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. Additionally, in some embodiments the vent 72 comprises a conduit (not shown) which vent the hazardous gas 24 from the drip chamber 40 inwardly chemical protection (not shown) or other container to prevent unwanted exposure to hazardous gas 24 to the environment.
[0048] Upon contact of the fluid 160 with the ventilation membrane 58, the flow of fluid 160 is interrupted, thus stopping the flow of fluid through the membrane 66. Before removal of the ventilation membrane 58, the cylindrical fastener 52 can retain the prepared state of patient conduit 50. This automatic preparation setting provides an efficient air purge within the system without the need to manually move air bubbles through flicking or other manual manipulation of system components 10 .
[0049] 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 overcome, thus resuming the flow of fluid through the conduit. With reference to figure 1C, a representative embodiment of a ventilation membrane activated by Luer 158 is illustrated. Those skilled in the art will appreciate that this modality represents only one of the many methods and designs by which a Luer-driven membrane can be provided. In general, end 54 comprises a plug 120 coupled insertably to an end of patient conduit 50. An opening between plug 120 and conduit 50 provides fluid communication between the two components. A flanged part 130 of plug 120 is provided as a means of securing a coupler (not shown) associated with a Luer device (not shown). An internal cavity 140 of plug 120 is configured to house the ventilation membrane 158 and the guidance device 152. In some embodiments, the guidance device 152 comprises a spiral spring or a perforated elastomeric material. In other embodiments, a portion of the ventilation membrane 158 is modified to provide a guiding function.
[0050] In some embodiments, a first end portion of cavity 140 comprises a retaining protrusion 142 having an inner diameter that is less than an outer diameter of the vent membrane 158. Cavity 140 further comprises a second pos end portion -supplying a stepped surface 144 to support the guide device 152. In this way, the membrane 158 and the guide device 152 are positioned interchangeably between the retaining protrusion 152 and the stepped surface 144 within the cavity 140. As configured, the guiding device 152 positions the membrane 158 against the retaining protrusion 152 so that a vent 154 is formed between the membrane 158 and the retaining protrusion 142. In this way, during the preparation process the air inside the system 10 is vented from system 10 through membrane 158, however, the physical properties of membrane 158 and / or seal 154 prevent passage of fluids.
[0051] With reference to figure 1D, the seal 154 is overcome by coupling the Luer 170 device to the end 54. The Luer 170 device can include any device having a configuration capable of activating the 158 blank. In some embodiments, the device Luer 170 comprises a body 172 having an accessory 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 tubing 210. The Luer 170 device it further comprises a probe part 176 configured to partially insert into plug 120 and contact membrane 158. Upon contact between probe part 176 and membrane 158, membrane 158 is repositioned so that seal 154 is overcome. A plurality of holes or inlets 178 located in probe part 176 provide fluid communication between plug 120 and internal cavity 182 of the Luer device 170 so that fluid can flow into catheter tubing 210.
[0052] Referring now to figure 3, following the preparation of drip chamber 40 and patient conduit 50, pin 30 of coupling assembly 20 is coupled to a first fluid reservoir 12. In some embodiments, the first reservoir of fluid fluid 12 is an IV pouch containing a dangerous chemical or drug 16. In other embodiments the first fluid reservoir 12 is a PA claw IV or other similar reservoir device. The fluid reservoir 12 generally includes a membrane 36 or perforable membrane through which pin 30 is compatiblely inserted. Once inserted, the cylindrical clamp 52 is released and the dangerous drug 16 can flow through the coupling assembly 20, into the drip chamber 40 and into the patient conduit 50, as shown in figure 4. For these modalities incorporating a rigid or semi-rigid IV gripper, part of the drip chamber 40 may additionally include ventilation 74. In some embodiments, ventilation 74 includes a filter designed to minimize the potential for aerosol or gaseous 24 passage of dangerous drugs within the delivery system IV 10, as the dangerous drug 16 moves through system 10.
[0053] With reference to figure 4, after the infusion of the dangerous drug 16, a washing fluid 160 is added to the drip chamber 40 via the automatic seal preparation / washing inlet 44. In some embodiments, the washing fluid 160 it is identical to the preparation solution 160. In other modalities, washing fluid 160 is a non-dangerous secondary drug. The washing fluid 160 pushes 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 part 102 of the delivery system. IV 10 of residual dangerous drug 16. Once a sufficient volume of washing fluid 160 has been infused, catheter 102 can be safely removed from the insertion site 106 without exposing the technician or patient 100 to the dangerous drug 16.
[0054] In some embodiments of the present invention, the IV 10 delivery system includes a coupling assembly 120 having multiple fluid channels 60 and 70, as shown in Figure 5. As previously discussed, the first fluid channel 60 provides a path of fluid between a coupled fluid reservoir 12 and the drip chamber 40 of the IV delivery system 10. In some embodiments, the first fluid channel 60 further comprises a second fluid channel 70 providing a fluid path between an inlet self-sealing access 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 part of the inlet 26 and the outlet 38 being in communication via fluid with fluid 160 from fluid reservoir 12. In some embodiments, the first fluid channel 60 and the second fluid channel 70 share a common dividing wall 22 running by 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 from the second fluid channel 70.
[0055] 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 Access port 26 is designed to receive a syringe 80 or other configured delivery device in a compatible manner to deliver a dangerous drug 16 to the fluid reservoir 12 via the second fluid channel 70. In some embodiments, access port 26 is designed to receive and irreversibly 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 part of the syringe 80. In other embodiments, the access port 26 and the syringe 80 are coupled together through a Luer lock coupling assembly.
[0056] Access port 26 generally includes an opening 90 for receiving a tip portion 82 of syringe 80. Access port 26 additionally includes a divided valve or membrane 84 which is opened by inserting tip 82 into opening 90 Prior to insertion of tip portion 82, membrane 84 is oriented in a closed and sealed configuration, thereby preventing leakage of preparation fluid 160 into the second fluid channel 70 through outlet 38. In some embodiments , the carrier fluid is the preparation fluid 160 of the fluid reservoir 12. For some embodiments, where the tip part 82 and opening 90 are reversibly coupled or reversibly interlocked by removing tip 82 from the opening 90, the membrane 84 resumes its closed and sealed configuration, thus preventing leakage of fluid from the second fluid channel 170.
[0057] In some embodiments of the present invention, the drip chamber 40 and patient conduit 50 are prepared with a preparation fluid 160 prior to the injection of the dangerous drug 16 through the access port 26. The process of preparing the System 10 requires that a pin part 30 of coupling assembly 120 be first inserted into the first fluid reservoir 12 containing preparation fluid 160. For those embodiments that are configured in an automatic preparation configuration, preparation fluid 160 from the first fluid reservoir 12 it automatically flows into the drip chamber 40 and the patient conduit 50, thereby providing a second reservoir of fluid 42 in addition to displacing the air within the conduit 50.
[0058] In some embodiments, the system 10 is configured to exclude the ventilation membrane 58, and comprises only a membrane 66. For these modalities, the process of preparing the system 10 comprises first the obstruction of the patient's conduit 50 through a cylindrical fastener 52 or similar fixing device. After the obstruction, the pin part 30 of the coupling assembly 120 is inserted into the first fluid reservoir 12. A flexible part 72 of the drip chamber 40 is then compressed or otherwise manipulated to draw fluid 160 into the drip chamber 40 through the first fluid channel 60, as is conventional. Once a second fluid reservoir 42 is formed, the cylindrical holder 52 is released and the preparation fluid 160 resumes the flow of the first reservoir 12 and through the patient conduit 50 to purge the air within the conduit 50.
[0059] In other embodiments, the system 10 is configured to exclude the membrane 66 and comprises only a ventilation membrane 58. For these modalities, the process of preparing the system 10 comprises the insertion of the pin part 30 of the coupling assembly 120 into the first fluid reservoir 12 before obstructing patient conduit 50 through a cylindrical clamp 52. Preparation fluid 160 flows freely from the first fluid reservoir 12 into drip chamber 40 and patient conduit 50. Once the preparation fluid 160 reaches the ventilation membrane 58, the fluid flow ceases and the patient duct 50 is obstructed through the cylindrical holder 52. At that point, system 10 is completely prepared with the preparation fluid 160 resulting in the complete displacement and purging of air inside the patient's conduit 50. In some embodiments, the dust cover 56 and the adjacent ventilation membrane 58 are removed from the end from terminal 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.
[0060] 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 port 26, so that the tip portion 82 guides the membrane 84 into the open position. Syringe 80 is then driven to deliver a dangerous drug 16 to the first fluid reservoir 12. The dangerous drug 16 and the preparation fluid 160 of the first fluid reservoir are mixed to provide a desired concentration of dangerous drug 16 in the preparation fluid 160 The cylindrical holder 52 is then released to resume fluid flow 16 through the system 10 and into the patient 100 through the coupled catheter 102.
[0061] In some embodiments, the patient conduit 50 additionally includes a washing inlet 86. The washing inlet 86 generally comprises an adapter coupled to an external surface of the patient conduit 50. The washing inlet 86 including an opening 88 configured to accept a tip portion 182 of a syringe 180 in a compatible manner. In some modalities, opening 88 additionally comprises a membrane 84 that can be oriented to an open position by introducing the tip portion of syringe 182 in aperture 88. In other embodiments, aperture 88 further comprises a perforable membrane that is overcome to an open position by introducing a syringe tip 182 into aperture 88. Other embodiments of flushing inlet 86 include a valve or other device that allows a syringe 180 to fluidly access patient conduit 50, as illustrated in figure 7.
[0062] Referring now to figure 7, system IV is illustrated after the infusion of the dangerous drug 16. In some embodiments, a dangerous vapor 24 and an unused dangerous drug remain in the first fluid reservoir 12 after the infusion procedure. In other embodiments, syringe 80 and access port 26 are irreversibly interlocked to prevent removal of syringe 80 resulting in unwanted exposure to the remaining dangerous drug 16. For those modalities comprising a dry non-slip membrane 66, the drug hazardous 16 empties completely from the drip chamber 40, but does not drain beyond membrane 66. Instead, the hazardous drug 16 remains within membrane 66 and prevents the introduction of air into patient conduit 50. As a result, dangerous drug flow 16 through patient conduit 50 ceases to result in patient conduit 50 to be filled with dangerous drug 16. Additionally, the inserted part of catheter 102 remains contaminated with the dangerous drug 16. Thus, in some modalities a surface The external part of patient conduit 50 is modified to include a washing inlet 86. The washing inlet 86 is configured to receive a serially compatible form. ga 180 containing a priming or washing fluid 160 to rinse the catheter part 102 of the IV delivery system 10 prior to removal of catheter 102 from patient 100.
[0063] The process of washing the patient's conduit 50 through the washing inlet 86 requires first that the patient's conduit 50 is obstructed through the cylindrical fastener 52. In some embodiments, the cylindrical fastener 52 is positioned interchangeably on the surface outflow of patient conduit 50 between drip chamber 40 and flushing port 86. Once patient conduit 50 has been blocked, syringe 180 is inserted into opening 88 of flushing port 86 to provide fluid communication between the syringe 180 and fluid 16 within patient conduit 50. Syringe 180 is then actuated to inject and infuse wash fluid 160 into the patient via patient conduit 50 and catheter 102. In the process of infusing wash fluid 160 , the downstream part of patient conduit 50, in addition to the inserted part of catheter 102 is deeply rinsed with the washing fluid 160. As such, the inserted part of catheter 102 is decontaminated from the dr dangerous substance 16 and can be safely removed without exposure to the dangerous drug 16. The IV 10 delivery system, coupled syringes 80 and 180, and the remaining dangerous drug 16 can then be safely disposed of without topical exposure or by inhaling the drug dangerous 16.
[0064] Several features of the present invention can be used in combination to provide an IV 10 delivery system for safely administering a dangerous drug 16 to a patient 100. For example, with reference to figure 8, an IV 10 delivery system is provided incorporating both a preparation / wash inlet 44 and an access inlet 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 an attached drip chamber 40. In some embodiments, a pin portion 30 of the coupling assembly 120 is inserted into a fluid reservoir 12, such as an IV pouch or bottle IV. 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.
[0065] The second fluid channel 70 forms part of the coupling assembly 120 and generally runs parallel to an access port 26 where 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 pin part 30 of coupling assembly 120. Thus, when pin part 30 of coupling assembly 120 is inserted into a first fluid reservoir 12, a fluid 16 can be injected into of 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 fluid delivery apparatus in a compatible manner similar. In other embodiments, opening 90 is modified to include an accessory for the reversible interlock of syringe 80 and access port 26. Additionally, in some embodiments, opening 90 is modified to include an accessory or accessories and permanently interlock the syringe 80 and access port 26.
[0066] In some embodiments, a portion of the drip chamber 40 is modified to include a preparation / wash entrance 44. The preparation / wash entrance 44 provides direct access to the drip chamber 40, as previously discussed with figures 1 to 4 above. Thus, in some modalities the drip chamber 40 and patient conduit 50 are prepared with a preparation solution 160 using a syringe 180 and the preparation / wash inlet 44, as shown in figure 8. In other embodiments, the drip chamber 40 and patient conduit 50 are prepared by inserting the pin part 30 of the coupling assembly 102 into a first fluid reservoir 12 containing a preparation fluid 160, as shown in figure 9. For these modalities the implementation of a ventilation membrane 58, the preparation fluid 160 automatically flows into the drip chamber 40 and through the patient's conduit displacing the air present there.
[0067] After the preparation procedures of figures 8 and 9, patient conduit 50 is blocked with a cylindrical fastener 52 and a dangerous drug 16 is introduced into the first fluid reservoir 12 through the second fluid channel 70 and access inlet 26, as shown in figure 10. Generally, a tip portion of syringe 80 is inserted into opening 90 of access port 26 to guide to open membrane 84 and initiate fluid communication between syringe 80 and the second fluid channel 70. The highly concentrated dangerous drug 16 inside 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 preparation fluid 160 of the first fluid reservoir 12 to supply a solution of the dangerous drug 16 in a desired concentration. The cylindrical clamp 52 is then released to allow diluted dangerous drug 16 to flow into the drip chamber 40 and patient conduit 50. In some embodiments, the ventilation membrane 58 and the dust cap 56 are replaced by a catheter. have intravenous 102 to allow intravenous infusion of the dangerous drug 16 into a patient 100.
[0068] After the infusion procedure of figure 10, the remaining dangerous drug 16 inside the drip chamber 40 and patient conduit 50 is washed into patient 100 by adding a washing fluid 160 to the drip chamber through of the preparation / wash inlet 44, as shown in figure 11. In some embodiments, the wash fluid 160 is the same as the preparation fluid 160 in figure 9. In other embodiments, the wash fluid 160 is a secondary drug not dangerous. As the washing fluid 160 flows through the drip chamber 40, patient conduit 50, and catheter 102, the residual dangerous drug 16 is infused into patient 100. Additionally, components 40, 50 and 102 are decontaminated from the dangerous drug 16 thus allowing safe removal of catheter 102 from patient 100 without the possibility of topical or inhaled exposure to drug 16 or dangerous vapor 24. After removal of catheter 102, delivery system IV 10, residual drug 16, and the coupled syringes 80 and 180 are properly arranged.
[0069] In some embodiments of the present invention, the IV delivery does not include a non-slip dry membrane 66 or a ventilation membrane 58. For these modalities, a physician initiates the flow from the fluid reservoir 12 by squeezing a flexible part 72 of the chamber drip 40, as is conventional. In other embodiments, the drip chamber 40 and patient conduit 50 are pre-prepared from the manufacturer with a preparation fluid 160. Before attaching the coupling assembly 20 or 120 to the first fluid reservoir 12, the patient's conduit 50 is obstructed through a clamp 52. A dangerous drug 16 is then injected into the fluid reservoir 12 through access port 26, and the flow is initiated through system 10 by releasing clamp 52. In some the holder 12 is selectively adjustable to allow a desired flow rate through patient conduit 50. In other embodiments, the residual drug 16 remaining in the second fluid channel 70 is washed into the first fluid reservoir 12 by the drive repeated from syringe 80.
[0070] A common practice is to pre-injection a fluid reservoir 12 with a dangerous drug 16 before delivery to a doctor. Pre-injection of the dangerous drug 16 is commonly performed by a pharmacist or other technician under chemical protection or in a well-ventilated area. Pre-injection eliminates the need for a doctor to handle the highly concentrated dangerous drug and additionally ensures proper dosing. The pre-injected reservoir is distributed to the doctor for administration to the patient. Some embodiments of the present invention are used in conjunction with pre-injected reservoirs, in addition to multiple reservoirs or fluid reservoirs connected in series.
[0071] 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 the patient's conduit 50 is purged by preparing conduit 50 directly with the dangerous drug 16 from a pre-injected fluid reservoir 12. As the dangerous drug 16 leaves the drip chamber 40 and proceeds through patient conduit 50, the dangerous vapor 24 of the dangerous drug 16 is pushed through the conduit 50. While the flow restriction device 58 prevents the liquid dangerous drug 16 from leaving the conduit 16, the device 58 is doubly designed to readily allow the passage of the dangerous vapor 24. Thus, during the preparation process, the doctor may be undesirably exposed to dangerous steam 24.
[0072] Therefore, in some embodiments of the present invention, the terminal end 54 of the patient conduit 50 is compatiblely inserted into the access entrance 26 before the preparation of the IV set 10 with the dangerous drug 16. Once the the end of the terminal is coupled to the access inlet 26, the predecessor 52 is released to initiate the flow of dangerous drug 16 into the drip chamber 40. As the dangerous drug 16 moves through patient conduit 50, the dangerous vapor 24 is displaced 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 trapped air, and the dangerous vapor 24 of the drug dangerous 16 has its gas removed into the fluid reservoir 12 and contained in the system 10. This preparation process ensures deep preparation while preventing unsafe exposure of the dangerous drug 16 and vapors 24 to the doctor.
[0073] After the preparation process, the conduit 50 is blocked again with the cylindrical fastener 52 and the terminal end 54 is removed from the access port 26. The doctor can then remove the dust cover 56 and the ventilation membrane 58 to allow fixation of conduit 50 to a patient 100 via a catheter 102. In some embodiments, the dust cap 56 additionally comprises a valve device where a catheter 102 is directly and fluidly coupled to the patient conduit 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 part of a V 102 catheter, where the IV 102 catheter is directly and fluidly coupled to the patient's conduit 50 without removal of the flow control device 58. With this, the physician can safely secure the patient conduit 50 to the patient 100 without being exposed to the dangerous drug 16 within the patient conduit 50. Additionally and, in some embodiments, the patient conduit 50 further comprises a flushing inlet 86 where the end end 54 and the coupled catheter 102 of the system 10 are flushed with a flushing fluid 116 prior to removal of the patient 100.
[0074] Referring now to figure 13, an implementation of the present invention is illustrated during the process of preparing patient conduit 50 with a dangerous drug. In some embodiments, the end end 54 of patient conduit 50 is coupled to a container 94 configured to receive and contain dangerous vapor 24 displaced from conduit 50 during the preparation 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 shield, or a filtration system. Additionally, in other embodiments, container 94 is a disposable bag or balloon.
[0075] In some embodiments, container 94 additionally comprises neutralizing or catalyzing the agents that sequester or otherwise interact with vapor 24 to reduce its threat. In other embodiments, the cap 56 or ventilation membrane 58 is further modified to allow attachment of the terminal end to a patient 100 through a catheter 100, or other device without exposing the physician to dangerous vapor 24 or dangerous drug 16 and within the conduit 50. In addition, some drip chambers 40 of the present invention include a preparation / wash inlet 44 where the dangerous drug 16 within patient conduit 50 and coupled catheter 102 is washed before removal from patient 100 after the procedure infusion.
[0076] Referring now to Figure 14, a primary IV set 200 is combined with a secondary IV set 300 to deliver a dangerous drug 16 to a patient 100 through a patient conduit 50. In that embodiment, the secondary IV set 300 is coupled to primary IV set 200 via an in-line access inlet 202. Inline access in 202 allows a dangerous drug 16 from the second set of IV 300 to flow into patient conduit 50 and into patient 100. In in some embodiments, the conduit line 150 of the second set IV 300 includes a closed Luer tip 302 that automatically opens the fluid path by attaching the Luer tip 302 to the line access inlet 202. Additionally, by removing the Luer tip 302 from the inlet line access line 202, the fluid path is closed and the Luer tip 302 is cleaned by the flow of preparation fluid 160 through patient conduit 50. In some embodiments, the access port in line 202 includes a set of threads for receiving a rotary lock entry from the Luer 302 tip. For these modalities, the Luer 302 tip is opened by tightening the lock nut around the set of threads, and is closed to the as the lock inlet is released from the set of threads. In other embodiments, a proximal part of the line access entrance 202 is used to open and close the Luer tip 302 at or near the full engagement. Additionally, in some embodiments the Luer 302 tip includes a manual switch or valve to open and close the flow of fluid through the Luer 302 tip.
[0077] After the infusion of the dangerous drug 16, a cylindrical fastener 52 of the second set IV 300 is activated to obstruct the conduit line 150 of the second UV 300 set. The cylindrical fastener 52 of the patient conduit 50 is then released to allow preparation fluid 160 flows 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 patient conduit 50, so that the Luer tip 302 is rinsed to clean the dangerous drug 16 by the preparation fluid 160. In other embodiments, the online access port 202 includes a dead space that retains residual amounts of dangerous drug 16 after the infusion. Therefore, in some modes, a washing port 86 is incorporated into the conduit line 150 of the second set IV 300. The washing port 86 is accessed by a syringe to inject the preparation fluid 160 through a part distal from the conduit line 150. In this way, the washing inlet 86 allows the dead space of the line access inlet 202 to be sufficiently washed to remove the remaining dangerous drug 16. After the complete washing of the dangerous drug in the inlet access in line line 202 the patient conduit 50, catheter 102 can be safely removed from patient 100 without exposure to the dangerous drug 16. Additionally, in some modalities, the line access entrance 202 is a dead space connector zero. For example, in some embodiments, a zero dead space connector eliminates dead space without the flow path of patient conduit 50 and Luer tip 302.
[0078] The present invention can be embodied in other specific forms without distancing itself from its structures, methods or other essential characteristics as widely described here and claimed later. Thus, the described modalities 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 IV pump. Other embodiments of the present invention can be configured to exclude the use of a drip chamber or a flow metering device such as a cylindrical fastener or a flow disc. The scope of the invention is therefore indicated by the appended claims, rather than by the description above. All changes that fall within the meaning and equivalence range of the claims must be encompassed by their scope.

权利要求:
Claims (12)
[0001]
1. Apparatus (10) for safely administering hazardous material to a patient, the apparatus comprises: a patient conduit (50) from a set of primary (IV), said patient conduit (50) comprising: ( i) a first end coupled to a first fluid reservoir (12), said first fluid reservoir (12) having a preparation fluid (160), (ii) a lumen through which the preparation fluid (160 ) flows, (iii) a second end (54) for a patient's intravenous access (100), and (iv) an in-line access port (202) for coupling the conduit line (150) of an IV set secondary (300) to the patient conduit (50) of the primary IV set (200); wherein the conduit line (150) of the secondary IR assembly (300) has a first end and a second end, the first end being fluidly coupled to a second fluid reservoir (12) having a hazardous material ( 16), and the second end being fluidly coupled to the patient duct (50) of the primary IV set (200) via the inline access entry via a closed Luer tip (302) that automatically opens the fluid path by fixing the Luer tip (302) to the line access inlet (202) to deliver the hazardous material (16) from the second set IV (300) via the secondary line IV (150) in the conduit (50) and patient (100), CHARACTERIZED by the fact that when the second end of the conduit line (150) of the secondary IV set (300) is fluidly coupled to the patient conduit (50) of the primary IV set (200) via the line access entry (202) via the Luer tip (302), a portion the Luer tip (302) is positioned in the flow path in the lumen of the patient's conduit (50) so that after administration of the hazardous material (16) the Luer tip (302) is removed from the in-line access (202 ) and the fluid path is closed, the Luer tip (302) and the patient conduit lumen (50) are rinsed from the hazardous material (16) by the preparation fluid (160).
[0002]
2. Apparatus according to claim 1, CHARACTERIZED by the fact that the line access input (202) is a zero dead space connector.
[0003]
3. Apparatus according to claim 1, CHARACTERIZED by the fact that it additionally comprises a washing inlet (86) disposed interchangeably on the secondary IV line (150) between the in-line access entrance (202) and the second reservoir of fluid (12), said washing inlet (86) being accessed by a syringe to inject preparation fluid (160) through the distal portion of the secondary IV line (150).
[0004]
4. Apparatus according to claim 1, CHARACTERIZED by the fact that it additionally comprises a ventilation membrane (58) coupled to the second terminal end (54) of the patient duct (50), said ventilation membrane (58) ) supplied as a hydrophobic air filter to allow air ventilation inside the distribution system, and also to prevent the passage of fluids (160).
[0005]
5. Apparatus according to claim 4, CHARACTERIZED by the fact that said ventilation membrane (58) comprises a porous material having a plurality of pores sized and configured to allow the passage of air, however preventing the passage of larger molecules , such as a fluid, a dangerous solution, or a dangerous solute.
[0006]
6. Apparatus according to claim 4, CHARACTERIZED by the fact that said ventilation membrane (58) comprises at least one among polytetrafluoroethylene, hydrophilic nylon, hydrophilic polypropylene, hydrophilic polyethersulfone, or a non-woven material coated with those materials.
[0007]
7. Apparatus according to claim 4, CHARACTERIZED by the fact that it additionally comprises a dust cover (56), the ventilation membrane (58) being included in the dust cover (56).
[0008]
8. Apparatus according to claim 4, CHARACTERIZED by the fact that the ventilation membrane (58) is a ventilation membrane activated by Luer (158).
[0009]
9. Apparatus according to claim 8, CHARACTERIZED by the fact that, by coupling a Luer device (170) to the second terminal end (54) of the patient duct (50), the ventilation membrane (58) is automatic -astically unsuccessful, thus resuming the flow of fluid through the conduit.
[0010]
10. Apparatus, according to claim 9, CHARACTERIZED by the fact that the ventilation membrane activated by Luer (158) is housed within a cavity (140) of a plug (120), said plug being inserted in the second ex - terminal end (54) of the patient's conduit (50), being in fluid communication with the patient's conduit (50) and also housing a guidance device (152) inside the internal cavity (140).
[0011]
11. Apparatus according to claim 10, CHARACTERIZED by the fact that the guiding device (152) is provided by modifying a portion of the ventilation membrane (158).
[0012]
12. Apparatus according to claim 10, CHARACTERIZED by the fact that the ventilation membrane activated by Luer (158) and the guiding device (152) are positioned interchangeably between a retaining projection (142) in a first end portion of the cavity (140) and a scaled-out surface (144) on a second end portion of the cavity (140), said retaining projection supporting the guiding device (152) and said guiding device ( 152) by positioning the Luer-activated ventilation membrane (158) against the retaining ledge (142), so as to form a seal (154) between the membrane (158) and the retaining ledge (142), said membrane ( 158) and / or sealing thus preventing the passage of fluids during a preparation process and said sealing (154) being overcome by coupling a Luer device (170) to the second terminal end (54) of the patient (50).

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法律状态:
2018-12-26| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|

2019-08-13| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|

2020-03-31| B07A| Technical examination (opinion): publication of technical examination (opinion) [chapter 7.1 patent gazette]|

2020-09-01| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|

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:

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US12/775,143|US20110276031A1|2010-05-06|2010-05-06|Systems and methods for providing a closed venting hazardous drug iv set|

PCT/US2011/032510|WO2011139517A1|2010-05-06|2011-04-14|Systems and methods for providing a closed venting hazardous drug iv set|

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