System and method for priming intravenous line
The closed-system transfer device addresses the challenge of priming an intravenous line with hazardous drugs by using a closed system to transfer fluid into a collection container, thereby minimizing exposure risks and ensuring safe handling.
Patent Information
- Application Number
- JP2025065135
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2020-02-05
- Filing Date
- 2025-04-10
- Publication Date
- 2025-06-26
AI Technical Summary
The challenge is to prime an intravenous line with a hazardous drug while minimizing exposure risks to healthcare providers and patients, as releasing the hazardous drug into an un-sealed receptacle poses a risk.
A closed-system transfer device is used, which includes a first and second connector, a collection device with a cannula and sleeve, and a collection container with a closure. This system allows for the transfer of fluid from the intravenous line into a collection container without leakage, using a closed system to manage hazardous drugs.
The system effectively primes the intravenous line with hazardous drugs while maintaining a closed system to prevent exposure risks, ensuring safe handling and administration of hazardous medications.
Smart Images
Figure 2025096509000001_ABST
Abstract
Description
Technical Field
[0001] Cross - Reference to Related Applications This application claims priority to U.S. Provisional Application Serial No. 62 / 970,226, filed on February 5, 2020, entitled "System and Method for Priming an Intravenous Line", the entire disclosure of which is incorporated herein by reference in its entirety.
Background Art
[0002] Background of the Invention Field of the Disclosure This application relates generally to systems and methods for priming an intravenous line.
[0003] Description of the Related Art Healthcare providers who reconstitute, transport, and administer dangerous drugs such as chemotherapeutic agents can expose themselves to risks of these drugs and pose significant risks in a healthcare environment. For example, healthcare workers treating cancer patients are at risk of exposure to chemotherapeutic agents and their toxic effects. Unintentional exposure to chemotherapy can affect the nervous system, damage the reproductive system, and potentially increase the risk of developing blood cancer in the future. To reduce the risk of healthcare workers being exposed to toxic drugs, the closed transfer of these drugs becomes important.
Summary of the Invention
Problems to be Solved by the Invention
[0004] After connecting an intravenous line to an infusion container containing a hazardous drug using a connector such as an intravenous bag spike, the intravenous line needs to be primed before injecting the drug in the infusion container into the patient. The intravenous line may be pre-primed using an appropriate fluid such as normal saline. However, if it is desired to prime the line with the hazardous drug, the hazardous drug is pushed through the intravenous line, and any fluid from the line is received in a receptacle such as a waste receptacle to remove air. The release of the hazardous drug into an un-sealed receptacle poses a risk to healthcare providers and patients. **Means for Solving the Problem**
[0005] **Summary of the Invention** In one aspect or embodiment, a system for priming an intravenous line includes a closed-system transfer device having a first connector and a second connector, wherein the first connector of the closed-system transfer device is configured to be connected to the connector of the intravenous line, and includes a connector device having a first connector and a second connector, wherein the first connector of the connector device is configured to be connected to the second connector of the closed-system transfer device, a collection device having a first connector, a cannula having a distal end, and a sleeve having a first position in which the distal end of the cannula is positioned within the sleeve and a second position in which the distal end of the cannula is positioned outside the sleeve. The first connector of the collection device is configured to be connected to the second connector of the connector device. The system also includes at least one collection container having a closure, the collection container defining a volume having a negative pressure. The cannula of the collection device is configured to pierce the closure of the collection container.
[0006] The closed-system transfer device may be a syringe adapter. The connector device may be a patient connector. The closed-system transfer device may be a closable male Luer adapter. The connector device may be a needleless connector. The collection device may be a blood collection device, and at least one collection container may be a blood collection tube.
[0007] The closed - system transfer device, the connector device, the collection device, and at least one collection container may be configured to facilitate the transfer of fluid from the intravenous line through the closed - system transfer device, the connector device, the collection device, and into at least one collection container without leakage outside the system.
[0008] The second connector of the closed - system transfer device may include a membrane, the first connector of the connector device may include a membrane, and the membrane of the second connector of the closed - system transfer device is configured to engage with the membrane of the first connector of the connector device.
[0009] In a further aspect or embodiment of the present invention, a method of priming an intravenous line includes providing the intravenous line and a closed - system transfer device having a first connector and a second connector, and connecting the closed - system transfer device to the intravenous line. The method also includes providing a connector device having a first connector and a second connector, providing a collection device having a first connector, a cannula having a distal end, and a sleeve having a first position in which the distal end of the cannula is positioned within the sleeve and a second position in which the distal end of the cannula is positioned outside the sleeve, and connecting the connector device to the collection device. The method further includes connecting the closed - system transfer device to the connector device, providing a collection container having a closure, defining a volume of the collection container having a negative pressure, and priming the intravenous line by inserting at least one collection container into the collection device such that the cannula of the collection device pierces the closure of the collection container.
[0010] The first connector of the connector device may be configured to be connected to the second connector of the closed - system transfer device, and the first connector of the collection device may be configured to be connected to the second connector of the connector device.
[0011] In a particular configuration, the method may include removing the collection device and the connector device from the closed - system transfer device.
[0012] The closed - system transfer device may include a syringe adapter, and the connector device may include a patient connector. Optionally, the closed - system transfer device may include a closable male Luer adapter, and the connector device may include a needle - free connector. In a further configuration, the collection device may include a blood collection device, and at least one collection container may be a blood collection tube.
[0013] Brief Description of the Drawings The above and other features and advantages of the present disclosure, and the manner in which they are achieved, will become more apparent by reference to the following description of embodiments of the present disclosure, taken in conjunction with the accompanying drawings, and the present disclosure itself will be better understood.
Brief Description of the Drawings
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[0015] Corresponding reference numerals indicate corresponding parts throughout several views. The examples set forth herein are illustrative of exemplary aspects of the present disclosure and such examples are not to be construed as limiting the scope of the present disclosure in any way.
Mode for Carrying Out the Invention
[0016] Detailed Description The following description is provided to enable one of ordinary skill in the art to make and use the described aspects contemplated for carrying out the present invention. However, various modifications, equivalents, variations, and alternatives will remain readily apparent to one of ordinary skill in the art. All such modifications, variations, equivalents, and alternatives are intended to fall within the spirit and scope of the present invention.
[0017] For the following description, the terms "upper", "lower", "right", "left", "vertical", "horizontal", "top", "bottom", "lateral", "longitudinal", and derivatives thereof shall relate to the invention as oriented in the drawing figures. However, it is understood that the invention may assume various alternative modifications unless explicitly specified to the contrary. Also, it should be understood that the specific devices illustrated in the accompanying drawings and described in the following specification are merely exemplary embodiments of the invention. Accordingly, specific dimensions and other physical characteristics related to the embodiments disclosed herein should not be considered as limiting. All numerical values and ranges used in this specification and the claims are to be understood as being modified in all instances by the term "about". "About" means plus or minus 25 percent of the recited value, e.g., plus or minus 10 percent of the recited value. However, this should not be considered limiting for any analysis of values under the principle of equivalence.
[0018] The terms "first", "second", etc. are not intended to refer to a particular order or time sequence, but rather to different conditions, characteristics, or elements.
[0019] Referring to FIGS. 1 - 12, in one aspect or embodiment, a system 10 for priming an intravenous line 12 includes a closed - system transfer device 14, a connector device 16, a collection device 18, and a collection container 20. The closed - system transfer device 14 has a first connector 22 and a second connector 24, and the first connector 22 of the closed - system transfer device 14 is configured to be connected to a connector 26 such as a male Luer connector of the intravenous line 12. The intravenous line 12 may be connected to an infusion container 28 such as an IV bag via a bag spike 30 or other suitable equipment. The connector device 16 has a first connector 32 and a second connector 34, and the first connector 32 of the connector device 16 is configured to be connected to the second connector 24 of the closed - system transfer device 14. The collection device 18 has a first connector 36, a cannula 38 having a distal end 40, and a sleeve 42 having a first position where the distal end 40 of the cannula 38 is positioned within the sleeve 42 and a second position where the distal end 40 of the cannula 38 is positioned outside the sleeve 42. More specifically, the sleeve 42 is configured to be compressed when the collection container 20 is inserted into the collection device 18, moving the sleeve 42 from the first position to the second position. When the collection container 20 is removed, the sleeve 42 is configured to return to the first position to seal the cannula 38 of the collection device 18. The first connector 36 of the collection device 18 is configured to be connected to the second connector 34 of the connector device 16. The collection container 20 includes a closure 44 and the collection container 20 defines a volume 46 having a negative pressure. The cannula 38 of the collection device 18 is configured to pierce the closure 44 of the collection container 20. Although one collection container 20 is shown, the system 10 may include one or more collection containers 20. In one embodiment or aspect, the first connector 22 of the closed - system transfer device 14 is a female Luer lock configured to be connected to the male Luer connector 26 on the intravenous line 12.
[0020] As will be discussed in more detail below, the closed - system transfer device 14, the connector device 16, the collection device 18, and at least one collection container 20 are configured to facilitate the transfer of fluid from the intravenous line 12 through the closed - system transfer device 14, the connector device 16, the collection device 18, and into at least one collection container 20 without leaking outside the system 10.
[0021] Referring to FIGS. 2 and 6, in one embodiment or aspect, the closed - system transfer device 14 is a syringe adapter having a cannula 52 and a seal device 54 having a membrane 56. The seal device 54 moves within the closed - system transfer device 14 between a sealed position where the distal end 58 of the cannula 52 is sealed by the membrane 56 and a transfer position (not shown) where the distal end 58 of the cannula 52 extends through the membrane 56, and is configured such that the cannula 52 can be placed in fluid communication with a combined connector such as the connector device 16. When the connector device 16 is inserted into the closed - system transfer device 14, the seal device 54 is moved to the transfer position to place the cannula 52 in fluid communication with the connector device 16.
[0022] Referring to FIGS. 3 and 7, in one embodiment or aspect, the connector device 16 is a patient connector having a membrane 60 configured to engage the membrane 56 of the seal device 54 of the closed - system transfer device 14 when the connector device 16 is inserted into the closed - system transfer device 14. The first connector 32 of the connector device 16 includes a pair of arms 62 having protrusions 64 configured to engage the second connector 24 of the closed - system transfer device 14, which may be part of the housing 66 of the closed - system transfer device 14. Alternatively, or in addition, the first connector 32 of the connector device 16 includes a proximal portion 68 of the connector device 16, which engages a collet 70 of the closed - system transfer device 14.
[0023] Referring to FIGS. 9 and 10, in a further embodiment or aspect, the connector device 16 is a needleless connector 72 having an elastomeric sleeve 74, the first connector 32 is a female Luer connector, and the second connector 34 is a male Luer connector. The needleless connector 72 may be a SmartSite™ available from Becton, Dickinson and Company, although other suitable needleless connectors may be utilized.
[0024] Referring to FIGS. 11 and 12, in a further embodiment or aspect, the closed system transfer device 14 is a closed male Luer 76 having a valve device 78. The first connector 22 is a female Luer connector, and the second connector 24 is a male Luer connector configured to cooperate with the needleless connector 72 of FIGS. 9 and 10. The closed male Luer 76 may be a Texium™ closed male Luer available from Becton, Dickinson and Company, although other suitable closed male Luers may be utilized.
[0025] In one embodiment or aspect, the closed system transfer device 14 is integrally formed, coupled, or adhered to the intravenous line 12 or the male Luer connector 26 of the intravenous line 12. In one embodiment or aspect, the connector device 16 is integrally formed, coupled, or adhered to the collection device 18.
[0026] Referring to FIG. 8, in one embodiment or aspect, the collection device 18 is a blood collection device and the collection container 20 is a blood collection tube such as a BD Vacutainer® blood collection tube, although other suitable collection devices or collection containers may be utilized.
[0027] Referring to FIGS. 2-5, in one embodiment or aspect, a method of priming the intravenous line 12 using the system 10 includes connecting the closed system transfer device 14 to the intravenous line 12 (FIG. 2); connecting the connector device 16 to the collection device 18 (FIG. 3); connecting the closed system transfer device 14 to the collection device 18 (FIG. 3); connecting the closed system transfer device 14 to the connector device 16 (FIG. 4); and priming the intravenous line 12 by inserting at least one collection container 20 into the collection device 18 such that the cannula 38 of the collection device 18 punctures the closure 44 of the collection container 20 (FIGS. 4 and 5). The method may further include removing the collection device 18 and the connector device 16 from the closed system transfer device 14.
[0028] The first connector 22 of the closed system transfer device 14 is connected to the male luer connection 26 of the intravenous line 12, the second connector 34 of the connector device 16 is fixed to the first connector 36 of the collection device 18, and the second connector 24 of the closed system transfer device 14 is fixed to the first connector 32 of the connector device 16. When the collection container 20 is inserted into the collection device 18, the cannula 38 punctures the closure 44 of the collection container 20 while the cannula 38 is in fluid communication with the volume portion 46 having a negative pressure, and the collection container 20 moves the sleeve 42 from the first position to the second position. The negative pressure in the collection container 20 draws air and / or fluid from the intravenous line 12, through the closed system transfer device 14, through the connector device 16, through the collection device 18 and the cannula 38 of the collection device 18, and into the collection container 20, thereby purging air from the intravenous line 12. After removing the connector device 16 and the collection device 18 from the closed system transfer device 14, the closed system transfer device 14 may remain connected to the intravenous line 12 to facilitate injection into the patient. The system 10 is configured to prime the intravenous line 12 while preventing leakage and / or dripping from the system 10 and the intravenous line 12 while in the presence of a hazardous drug. Although one collection container 20 is shown, priming of the intravenous line 12 and other components may require one or more collection containers 20 depending on the volume of the intravenous line 12 and other components, as well as the volume portion 46 of the collection container 20.
[0029] Although the present disclosure has been described as having exemplary designs, the present disclosure can be further modified within the spirit and scope of the present disclosure. Accordingly, this application is intended to cover any variations, uses, or adaptations of the present disclosure using its general principles. As far as possible, one or more features of any embodiment or aspect can be combined with one or more features of any other embodiment or aspect. Further, this application is intended to cover departures from the present disclosure that come within known or customary practice in the technical field to which the present disclosure pertains and fall within the scope of the appended claims.
Claims
1. 1. A system for priming an intravenous line, comprising: a closed system transfer device comprising a first connector, a second connector, and a cannula extending at least partially between the first connector and the second connector, the first connector of the closed system transfer device being configured to be connected to a connector of an intravenous line; a connector device comprising a first connector and a second connector, the first connector of the connector device configured to be received within and connected to the second connector of the closed system transfer device; a collection device including a first connector, a cannula having a distal end, and a sleeve, the sleeve having a first position in which the distal end of the cannula of the collection device is positioned within the sleeve and a second position in which the distal end of the cannula of the collection device is positioned outside of the sleeve, the first connector of the collection device configured to be connected to the second connector of the connector device; and at least one collection canister comprising a closure, the collection canister defining a volume having a negative pressure, the cannula of the collection device configured to pierce the closure of the collection canister; Equipped with the second connector of the closed system transfer device comprises a membrane, the first connector of the connector device comprises a membrane, and the membrane of the second connector of the closed system transfer device is configured to engage with the membrane of the first connector of the connector device; in a sealed position, a distal end of the cannula of the closed system transfer device is at least partially retained within the membrane of the second connector of the closed system transfer device; in a transfer position, the first connector of the connector device receives the second connector of the closed system transfer device, thereby causing the cannula of the closed system transfer device to extend through at least the membrane of the second connector of the closed system transfer device and form a fluid communication between the closed system transfer device and the connector device; The at least one collection container is insertable into the at least one collection device, and when the at least one collection container is inserted into the at least one collection device, the sleeve moves from the first position to the second position.
2. The system of claim 1 , wherein the closed system transfer device comprises a syringe adapter having a cannula and a sealing device having the membrane of the second connector.
3. 3. The system of claim 2, wherein the connector device comprises a patient connector having a membrane of the first connector that engages with the membrane of the sealing device of the closed system transfer device when the connector device is inserted into the closed system transfer device.
4. The system of claim 1 , wherein the closed system transfer device comprises a closable male luer adapter.
5. The system of any of claims 1 to 4, wherein the connector device comprises a needleless connector.
6. The system of any of claims 1 to 5, wherein the collection device comprises a blood collection device and the at least one collection vessel comprises a blood collection tube.
7. 7. The system of claim 1, wherein the closed system transfer device, the connector device, the collection device, and the at least one collection container are configured to facilitate transfer of fluid from an intravenous line, through the closed system transfer device, the connector device, the collection device, and into the at least one collection container.
8. The system of claim 7 , wherein the closed transfer device, the connector device, and the collection device are configured to transfer the fluid from the venous line into at least one collection container without leakage.
9. 1. A method of priming an intravenous line, the method comprising: a closed system transfer device comprising an intravenous line, a first connector, a second connector, and a cannula extending at least partially between the first connector and the second connector; connecting the closed system transfer device to the intravenous line; A connector device is provided, the connector device comprising a first connector and a second connector; providing a collection device comprising a first connector, a cannula having a distal end, a sleeve having a first position in which the distal end of the cannula is positioned within the sleeve, and a second position in which the distal end of the cannula is positioned outside of the sleeve; connecting the connector device to the collection device; connecting the closed system transfer device to the connector device by securing the first connector of the connector device within the second connector of the closed system transfer device, thereby engaging a membrane of the second connector of the closed system transfer device with a membrane of the first connector of the connector device and extending the cannula of the closed system transfer device through at least the membrane of the second connector of the closed system transfer device; providing a collection canister comprising a closure, the collection canister defining a volume having a negative pressure; and inserting the collection container into the collection device and moving the sleeve from the first position to the second position with the cannula of the collection device puncturing the closure of the collection container to prime the intravenous line.
10. 10. The method of claim 9, wherein the first connector of the connector device is configured to connect to the second connector of the closed system transfer device.
11. The method of claim 9 , wherein the first connector of the collection device is configured to be connected to a second connector of the connector device.
12. The method of claim 9 , further comprising removing the collection device and the connector device from the closed system transfer device.