Syringe adapter with membrane housing
The syringe adapter with a membrane housing and biasing member simplifies hazardous drug transfer and arterial catheter procedures, reducing exposure risks and environmental contamination while ensuring sealed and efficient fluid transfer.
Patent Information
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- BECTON DICKINSON & CO
- Filing Date
- 2024-05-13
- Publication Date
- 2026-06-05
Smart Images
Figure 2026518350000001_ABST
Abstract
Description
Technical Field
[0001] The present invention relates to a syringe adapter having a membrane housing.
[0002] Cross - reference to Related Applications This application claims the priority of U.S. Provisional Application No. 63 / 468,896, titled "Syringe Adapter with Membrane Housing", filed on May 25, 2023, the entire disclosure of which is incorporated herein by reference.
Background Art
[0003] Healthcare providers who reconstitute, transport, and administer dangerous drugs such as chemotherapy drugs can expose themselves to the risk of exposure to these drugs and pose a risk to the healthcare environment. Unintentional exposure to chemotherapy can affect the nervous system, damage the reproductive system, and increase the risk of developing blood cancer in the future. Some drugs need to be dissolved or diluted before administration, which involves transferring a solvent from a separate container into a sealed vial containing a powdered or liquid drug. When aspirating the drug solution from the vial, if there is a pressure difference between the inside of the vial and the surrounding atmosphere, the drug may be inadvertently released into the atmosphere in gaseous or aerosolized form. To reduce the risk of healthcare providers being exposed to toxic drugs, the transfer of these drugs is carried out using a transfer device or system in a closed system.
[0004] A syringe adapter is used to transfer a drug from a container such as a vial to a syringe or to transfer a diluent from the syringe to the vial to reconstitute the drug. The syringe adapter is also used to transfer a drug from the syringe to a patient's infusion line or to an infusion container such as an infusion bag via a spike for the infusion bag. The syringe adapter includes a membrane housed in a membrane housing, and the membrane of the syringe adapter engages with a membrane corresponding to a fitting component such as a patient connector, a vial adapter, or a spike for an infusion bag to ensure a sealed transfer of fluid between the components so that the drug is not exposed to the surrounding environment. [Overview of the project] [Problems that the invention aims to solve]
[0005] The current use of arterial catheters and associated arterial blood gas and blood sampling systems is complex, and it is recognized that there are numerous procedures that could be simplified, potentially leading to difficulties in cleaning the infusion line and interruptions in hemodynamic monitoring. For example, current systems used with arterial catheters require aspirating a large volume of clearing blood from the patient before sampling and sending it to a large, complex fluid extension set. The system then samples from the extension set, returns a large volume of blood to the patient, and further flushes the fluid in the flow path to remove the blood from within the extension set. [Means for solving the problem]
[0006] In one embodiment, the syringe adapter includes an outer housing having a first end and a second end positioned opposite the first end, and having a longitudinal axis extending from the first end to the second end of the outer housing, the outer housing comprising a side wall defining an internal space, a syringe connector configured to connect to a syringe, and a membrane housing disposed within the internal space of the outer housing and movable to a second position within the outer housing spaced apart from a first position within the outer housing. The membrane housing receives a membrane. The membrane housing includes a biasing member configured to engage with the side wall of the outer housing, the biasing member configured to provide a biasing force in a direction perpendicular to the longitudinal axis of the outer housing.
[0007] The inner diameter of the outer housing may be larger at the second end of the outer housing than at the first end of the outer housing, and the biasing member engages with the side wall of the outer housing as the membrane housing moves from a first position to a second position. The biasing member of the membrane housing may be configured to bias the membrane housing to the first position as the membrane housing moves from the first position to the second position. The inner diameter of the outer housing may change tapered from the first end to the second end of the outer housing. The biasing member may extend radially outward from the membrane housing. The biasing member may include a plurality of arcuate projections. Each of the plurality of arcuate projections may include a first end connected to the membrane housing, a second end located opposite the first end, and a contact surface configured to engage with the inner surface of the side wall of the outer housing. Each contact surface of the plurality of arcuate projections may have a radius equal to the radius of a portion of the inner surface of the side wall of the outer housing. The biasing member may be configured to center the membrane housing within the internal space of the outer housing. The membrane housing has a first end and a second end located opposite the first end of the membrane housing, and the biasing member is positioned between the first end and the second end of the membrane housing. The biasing member may be positioned closer to the first end of the membrane housing than to the second end of the membrane housing.
[0008] The syringe adapter may further include a needle housed within the internal space of the outer housing. When the membrane housing is in a first position, the puncture tip of the needle may be located inside the membrane; when the membrane housing is in a second position, the puncture tip of the needle may be located outside the membrane. The membrane housing may include a collet configured to accept the connection interface of a mating connector. [Brief explanation of the drawing]
[0009] [Figure 1] Figure 1 is a front view of a conventional syringe adapter. [Figure 2] Figure 2 is a cross-sectional view of the syringe adapter shown in Figure 1. [Figure 3] Figure 3 is a perspective view of a membrane housing according to one aspect or embodiment of this application. [Figure 4] Figure 4 is a top view of the membrane housing shown in Figure 3. [Figure 5] Figure 5 is a cross-sectional view of the membrane housing in Figure 3, showing the membrane housing engaging with the syringe adapter housing. [Modes for carrying out the invention]
[0010] Hereafter, for explanatory purposes, the terms “upper,” “lower,” “right,” “left,” “vertical,” “horizontal,” “top,” “bottom,” “lateral,” “longitudinal,” and their derivatives shall be used in relation to the present invention as oriented in the drawings. However, unless expressly specified otherwise, it should be understood that the present invention may take various alternative modifications and sequences of steps. It should also be understood that the specific devices and processes shown in the accompanying drawings and described in the following specification are merely illustrative embodiments of the present invention. Therefore, specific dimensions and other physical characteristics relating to the embodiments disclosed herein should not be construed as limiting. Furthermore, unless expressly specified otherwise, it should be understood that the present invention may take various alternative modifications and sequences of steps.
[0011] Referring to Figures 1 and 2, a conventional syringe adapter 10 is shown. The syringe adapter 10 is a component of a sealed fluid transfer system. In particular, the syringe adapter 10 is configured to connect a syringe (not shown) to another medical device or fluid container. The medical device may be, for example, a patient line, vial adapter, fluid container, or infusion adapter. The container may be a medical vial, syringe barrel, infusion bag, or similar container for holding a liquid to be administered to a patient. The syringe adapter 10 can be used to facilitate the sealed transfer of liquid between a syringe and a medical device or fluid container. The syringe adapter 10 is described and illustrated in U.S. Patent Application Publication No. 2018 / 0200147, which is incorporated herein by reference in its entirety.
[0012] Referring again to Figures 1 and 2, the syringe adapter 10 includes an outer housing 12, a syringe connector 14, and a membrane housing 16. The outer housing 12 has a first end 18 and a second end 20 positioned opposite the first end 18, and has a longitudinal axis A extending from the first end 18 to the second end 20. The outer housing 12 includes side walls 22 defining an internal space 24. The syringe connector 14 is configured to connect to a syringe. The syringe connector 14 may be a Luer connector, or other suitable connection configurations may be used. The membrane housing 16 is located within the internal space 24 of the outer housing 12 and is movable from a first position within the outer housing 12 to a second position within the outer housing 12 spaced apart from the first position. The outer housing 12 receives a membrane 26. The syringe adapter 10 further includes a needle 28 housed within the internal space 24 of the outer housing 12. When the membrane housing 16 is in a first position, the puncture tip 30 of the needle 28 is located inside the membrane 26, and when the membrane housing 16 is in a second position, the puncture tip 30 of the needle 28 is located outside the membrane 26. The membrane housing 16 includes a collet 32 configured to receive a connection interface 34 of a mating connector 36, such as a patient connector, as shown in Figures 1 and 2. The mating connector 36 includes a membrane 38. The mating connector 36 may be a transport device for a sealed system or another component of the system, such as a vial adapter or an infusion bag spike. The syringe adapter 10 further includes a spring 40 housed within the internal space 24 of the outer housing 12. The spring 40 biases the membrane housing 16 toward the first position.
[0013] When the mating connector 36 is inserted into the outer housing 12 of the syringe adapter 10, the collet 32 of the membrane housing 16 accepts the connection interface 34 of the mating connector 36, moving the membrane housing 16 within the outer housing 12 toward the first end of the outer housing 12. As the membrane housing 16 moves, the collet 32 secures the membrane housing 16 to the mating connector 36, ensuring engagement between the membrane 38 of the mating connector 36 and the membrane 26 of the membrane housing 16. As the membrane housing 16 moves from the first position to the second position, the puncture tip 30 of the needle 28 penetrates the membrane 26 of the membrane housing 16 and the membrane 38 of the mating connector 36, the puncture tip 30 is housed within the mating connector 36, and the needle 28 is in fluid communication with the mating connector 36. The syringe connection portion 14 is in fluid communication with the needle 28, and when the syringe adapter 10 is connected to the mating connector 36, the syringe (not shown) connected to the syringe connection portion 14 can communicate fluidly with the mating connector 36. When the membrane housing 16 is moved from the second position to the first position (this movement is assisted by the spring 40), the mating connector 36 is released from the collet 32 and separated from the syringe adapter 10. The membrane housing 16 is fixed in the second position by the locking mechanism 42 of the mating connector 36. This locking mechanism engages with a part of the outer housing 12 and holds the membrane housing 16 in the second position. When the mating connector 36 is pulled away from the syringe adapter 10, the locking mechanism 42 is released, and the membrane housing 16 can return from the second position to the first position.
[0014] Referring to Figures 3 to 5, according to one embodiment, the syringe adapter 10 includes a membrane housing 60 having a biasing member 62 configured to engage with the side wall 22 of the outer housing 12. The biasing member 62 is configured to provide a biasing force in a direction perpendicular to the longitudinal axis A of the outer housing 12. The membrane housing 60 receives a membrane 26 and is usable with the syringe adapter 10 shown in Figures 1 and 2, and operates similarly to the aforementioned membrane housing 16, except for the differences described below. The membrane housing 60 shown in Figures 3 to 5 can also be used in combination with other types of syringe adapters, such as a syringe adapter without a spring or a syringe adapter without a needle. The biasing member 62 of the membrane housing 60 is configured to automatically center the membrane housing 60 within the internal space 24 of the outer housing 12 in order to ensure consistent operation of the syringe adapter 10. The biasing member 62 of the membrane housing 60 is configured to compensate for dimensional variations in the components of the syringe adapter 10 and to ensure consistent functionality.
[0015] Referring to Figure 5, in one embodiment, the inner diameter 64 at the second end 20 of the outer housing 12 is larger than the inner diameter at the first end 18 of the outer housing 12. The biasing member 62 engages with the side wall 22 of the outer housing 12 as the membrane housing 60 moves from a first position to a second position. The biasing member 62 of the membrane housing 60 is configured to bias the membrane housing 60 back to the first position as the membrane housing 60 moves from the first position to the second position. In one aspect or embodiment, the biasing member 62 eliminates the need for a spring 40 and returns the membrane housing 60 from the second position to the first position. The inner diameter 64 of the outer housing 12 is tapered from the first end 18 to the second end 20 of the outer housing 12, but other suitable configurations can also be utilized. The biasing force provided by the biasing member 62 may increase as the membrane housing 60 moves towards a second position closer to the first end 18 of the outer housing 12. The biasing member 62 extends radially outward from the membrane housing 60. In one embodiment, the biasing member 62 is formed integrally with the membrane housing 60, but the biasing member 62 may be formed separately from the membrane housing 60 and fixed to the membrane housing 60 in any suitable way. As shown in Figures 3 and 4, the biasing member 62 is a plurality of arc-shaped protrusions 66, but one or more arc-shaped protrusions 66 may also be used. As shown in Figure 4, the biasing member 62 comprises five equally spaced arc-shaped protrusions 66.
[0016] Each of the multiple arc-shaped projections 66 comprises a first end 68 connected to the membrane housing 60, a second end 70 positioned opposite the first end 68, and a contact surface 72 configured to engage with the inner surface 74 of the side wall 22 of the outer housing 12. Each contact surface 72 of the multiple arc-shaped projections 66 has a radius equal to the radius of a portion of the inner surface 74 of the side wall 22 of the outer housing 12. Each contact surface 72 of the multiple arc-shaped projections 66 is curved, but other suitable configurations can also be used. The membrane housing 60 has a first end 78 and a second end 80 positioned opposite the first end 78 of the membrane housing 60. The biasing member 62 is positioned between the first end 78 and the second end 80 of the membrane housing 60. The biasing member 62 is positioned closer to the first end 78 of the membrane housing 60 than to the second end 80 of the membrane housing 60, but other suitable positions can also be used.
[0017] While this disclosure has been described to have an exemplary structure, it is subject to further modification within its spirit and scope. Therefore, this application is intended to encompass any variations, uses, or adaptations of this disclosure using its general principles. Furthermore, this application is intended to cover any deviations from this disclosure that fall within the scope of the appended claims, within the scope of known or customary practices in the relevant art. Wherever possible, one or more features of any aspect or embodiment described above can be combined with one or more features of any other aspect or embodiment.
Claims
1. It is a syringe adapter, An outer housing comprising a first end and a second end located opposite the first end, having a longitudinal axis extending from the first end to the second end, and having side walls defining an internal space, A syringe connector configured to connect to a syringe, A membrane housing disposed within the internal space of the outer housing and movable from a first position within the outer housing to a second position within the outer housing spaced apart from the first position, wherein the membrane housing houses a membrane, and the membrane housing includes a biasing member configured to engage with the side wall of the outer housing, the biasing member configured to apply a biasing force in a direction perpendicular to the longitudinal axis of the outer housing, A syringe adapter equipped with this feature.
2. The syringe adapter according to claim 1, wherein the inner diameter of the outer housing is greater at the second end of the outer housing than at the first end of the outer housing, and the biasing member engages with the side wall of the outer housing when the membrane housing moves from the first position to the second position.
3. The syringe adapter according to claim 2, wherein the biasing member of the membrane housing is configured to bias the membrane housing to the first position when the membrane housing moves from the first position to the second position.
4. The syringe adapter according to claim 2 or 3, wherein the inner diameter of the outer housing is tapered from the first end to the second end of the outer housing.
5. The syringe adapter according to any one of claims 1 to 4, wherein the biasing member extends radially outward from the membrane housing.
6. The syringe adapter according to claim 5, wherein the biasing member comprises a plurality of arc-shaped protrusions.
7. The syringe adapter according to claim 6, wherein each of the plurality of arc-shaped protrusions comprises a first end connected to the membrane housing, a second end located opposite the first end, and a contact surface configured to engage with the inner surface of the side wall of the outer housing.
8. The syringe adapter according to claim 7, wherein each of the contact surfaces of the plurality of arc-shaped protrusions has a radius equal to the radius of a portion of the inner surface of the side wall of the outer housing.
9. The syringe adapter according to any one of claims 1 to 8, wherein the biasing member is configured to center the membrane housing within the internal space of the outer housing.
10. The syringe adapter according to any one of claims 1 to 9, wherein the membrane housing comprises a first end and a second end located opposite to the first end, and the biasing member is disposed between the first end and the second end of the membrane housing.
11. The syringe adapter according to claim 10, wherein the biasing member is positioned closer to the first end of the membrane housing than to the second end of the membrane housing.
12. The syringe adapter according to any one of claims 1 to 11, further comprising a needle housed in the internal space of the outer housing.
13. The syringe adapter according to claim 12, wherein when the membrane housing is in the first position, the puncture tip of the needle is located inside the membrane, and when the membrane housing is in the second position, the puncture tip of the needle is located outside the membrane.
14. The syringe adapter according to any one of claims 1 to 13, wherein the membrane housing comprises a collet configured to accept the connection interface of a mating connector.