Membranes for closed transfer devices

Abstract

The membrane for the closed transfer device includes a first portion including a first material and a second portion including a second material. The first material has different material properties than the second material. The first portion is configured to prevent leakage therethrough when the first portion is pierced by a cannula for a first predetermined time, and the second portion is configured to prevent leakage therethrough when the second portion is pierced by a cannula for a second predetermined time. The first predetermined time is longer than the second predetermined time.

Description

[Technical Field]

[0001] The present invention relates to membranes for closed transfer devices. [Background technology]

[0002] This application claims priority to U.S. Provisional Application Serial No. 63 / 070,020, filed August 25, 2020, entitled "Membrane for Closed Transfer Device."

[0003] Healthcare providers who reconstitute, transport, and administer hazardous drugs, such as those used in cancer treatments, put themselves at risk for exposure and pose a potential hazard to the healthcare environment. Unintentional exposure to chemotherapy can affect the nervous system, impair the reproductive system, and increase the risk of developing blood cancers in the future. Some drugs must be dissolved or diluted before they can be administered. This involves using a needle to transfer a solvent from one container to a sealed vial containing the drug in powder or liquid form. If there is a pressure differential between the interior of the vial and the surrounding atmosphere, the drug may be unintentionally released into the atmosphere in the form of a gas or by aerosolization during the withdrawal of the needle from the vial and while the needle is inside the vial. To reduce the risk of healthcare providers being exposed to toxic drugs, the transfer of these drugs is achieved using closed transfer devices or systems.

[0004] A closed transfer device or system may utilize a membrane to ensure the safe transfer of fluid between components. For example, a syringe adapter may include a membrane that contacts the membrane of a mating component, such as a patient connector, an IV bag spike, or a vial adapter. Summary of the Invention

[0005] In one aspect or embodiment, a membrane for a closed transfer device includes a first portion having a first material and a second portion having a second material, the first material having different material properties than the second material. The first portion is configured to prevent leakage therethrough when the first portion is pierced by a cannula for a first predetermined time, and the second portion is configured to prevent leakage therethrough when the second portion is pierced by a cannula for a second predetermined time, the first predetermined time being longer than the second predetermined time.

[0006] The first material may be a thermoplastic elastomer. The second material may be polyisoprene. The first predetermined time may be one hour or more. The second predetermined time may be ten seconds or less. The first and second parts may be molded separately or integrally. The first part includes a body having a first side and a second side opposite the first side, the first part having a flange extending from the body. The second part includes a body having a first side and a second side opposite the first side, the second part having a flange extending from the body. The flange of the first part may abut against the flange of the second part.

[0007] In a further aspect or embodiment, the patient connector includes a body having a first end and a second end and defining a passageway, a line connection portion disposed at the second end of the body, and a membrane according to any of the above aspects or embodiments, wherein the membrane is disposed at the first end of the body.

[0008] The membrane may be received by an opening defined by the body. The opening may be wider than the passageway, the body of the first portion extending from the first end of the body, the flange of the first portion disposed within the opening, and the body of the second portion disposed within the passageway, the flange of the second portion disposed within the opening. The body of the patient connector may include a fixation extension at the first end of the body, the fixation extension extending radially inward and configured to fix the membrane to the body.

[0009] In another aspect or embodiment, a closed fluid transfer system includes a patient connector according to any of the above aspects or embodiments, a syringe adapter having a housing with a syringe adapter membrane contained within the housing, and a cannula. The syringe adapter membrane is movable from a first position within the syringe adapter housing to a second position within the housing when the patient connector is disposed within the syringe adapter housing. The patient connector membrane is configured to engage with the syringe adapter membrane. The cannula is configured to pierce the patient connector membrane when the patient connector is disposed within the syringe adapter housing. [Brief explanation of the drawings]

[0010] The above and other features and advantages of the present disclosure, and the manner in which they are achieved, will become more apparent, and the disclosure itself will be better understood, by reference to the following description of embodiments of the disclosure taken in conjunction with the accompanying drawings.

[0011] [Figure 1] FIG. 1 is a front view of a patient connector according to one aspect or embodiment of the present application. [Figure 2] 2 is a cross-sectional view of the patient connector of FIG. 1. FIG. [Figure 3] 3 is a cross-sectional view of the patient connector of FIG. 1 showing the patient connector being inserted into the syringe adapter. [Figure 4] FIG. 4 is a cross-sectional view of the patient connector of FIG. 1 showing the patient connector inserted into the syringe adapter.

[0012] Corresponding reference characters indicate corresponding parts throughout the several views. The exemplifications set forth herein illustrate exemplary aspects of the present disclosure, and such exemplifications should not be construed as limiting the scope of the present disclosure in any way. DETAILED DESCRIPTION OF THE INVENTION

[0013] The following description is provided to enable any person skilled in the art to make and use the described embodiments as contemplated for practicing the invention. However, various modifications, equivalents, variations, and alternatives will remain readily apparent to those skilled in the art. Any and all such modifications, variations, equivalents, and alternatives are intended to be within the spirit and scope of the present invention.

[0014] Hereinafter, for purposes of description, the terms "upper," "lower," "right," "left," "vertical," "horizontal," "top," "bottom," "transverse," "longitudinal," and derivatives thereof, shall refer to the present invention as oriented in the drawings. However, it should be understood that the present invention may assume various alternative modifications unless expressly specified to the contrary. It should also be understood that the specific devices illustrated in the accompanying drawings and described in the following specification are merely exemplary embodiments of the present invention. Accordingly, specific dimensions and other physical characteristics relating to the embodiments disclosed herein are not to be considered limiting.

[0015] 1-4, a membrane 10 for a closed transfer device according to one aspect or embodiment of the present application includes a first portion 12 having a first material and a second portion 14 having a second material. As shown in FIGS. 1 and 2, the membrane 10 is shown in association with a patient connector 16 and is utilized to connect one component of a closed transfer device or system to a patient's intravenous line. For example, the patient connector 16 may be connected to a syringe adapter 18 to facilitate the transfer of fluid from one container, such as a syringe barrel, to another container or line, such as an intravenous line, an IV bag, or other component. The membrane 10 may be utilized in any component of a closed transfer device or system. In one aspect or embodiment, the membrane 10 is utilized in each component that mates with the syringe adapter 18, such as the patient connector 16, a vial adapter, an IV bag spike, or the like. Syringe adapter 18 may be the same as and may operate in the same manner as the syringe adapter shown and described in U.S. Patent Application Publication No. 2015 / 0297454, which is incorporated herein by reference in its entirety.

[0016] 1 and 2, the first material of the first portion 12 of the membrane 10 has different material properties than the second material of the second portion 14. The first portion 12 is configured to prevent leakage therethrough when the first portion 12 is punctured by the cannula 20 for a first predetermined time, and the second portion 14 is configured to prevent leakage therethrough when the second portion 14 is punctured by the cannula 20 for a second predetermined time. The first predetermined time is longer than the second predetermined time. The first material is a thermoplastic elastomer, although other suitable materials may be utilized. In one aspect or embodiment, the first material may be a DRYFLEX® thermoplastic elastomer available from HEXPOL TPE. The second material is polyisoprene, although other suitable materials may be utilized.

[0017] In one aspect or embodiment, the first predetermined time is one hour or longer. In one aspect or embodiment, the second predetermined time is ten seconds or shorter. In one configuration, the first predetermined time may be approximately 24 hours, intended to prevent "long-term" leakage, while the second predetermined time may be on the order of a few seconds to a minute to prevent "short-term" leakage. As noted above, membrane 10 is utilized in connection with a closed transfer device or system, and during use, cannula 20 of syringe adapter 18 may puncture and withdraw from membrane 10 quickly, such as for a time period of ten seconds or less. Membrane 10 may also be utilized in scenarios in which cannula 20 of syringe adapter 18 punctures membrane 10 and remains in the punctured position for a longer time period, such as one hour or longer. Membrane 10 is configured to prevent leakage through membrane 10, such as through an opening caused by cannula 20 puncturing membrane 10 or through the interface between cannula 20 and membrane 10. First portion 12 of membrane 10 is configured to optimize sealing performance for a scenario in which membrane 10 is punctured and remains punctured for a first predetermined period of time. Second portion 14 of membrane 10 is configured to optimize sealing performance for a scenario in which membrane 10 is punctured for a second predetermined period of time. Thus, membrane 10, including first portion 12 and second portion 14, is configured to reduce leakage in both long-term and short-term puncture scenarios.

[0018] In one aspect or embodiment, the first portion 12 and the second portion 14 are molded separately. The first portion 12 and the second portion 14 may also be molded integrally. The first portion 12 and the second portion 14 each include a body 22, 30 having a first side 24, 32 and a second side 26, 34 opposite the first side 24, 32, with a flange portion 28, 36 extending from the body 22, 30. As shown in FIG. 2 , the flange portion 28 of the first portion 12 abuts the flange portion 36 of the second portion 14. The first and second portions 12, 14 of the membrane 10 may be circular, although other suitable shapes and configurations may be utilized. The first portion 12 may be secured to the second portion 14 by adhesive or any other suitable arrangement.

[0019] 1 and 2 , the patient connector 16 includes a body 40 having a first end 42 and a second end 44 and defining a passageway 46, a line connection 48 disposed at the second end 44 of the body 40, and a membrane 10 disposed at the first end 42 of the body 40. The line connection 48 may be a luer lock connection, although other suitable connections may be utilized. The membrane 10 is received by an opening 50 defined by the body 40 of the patient connector 16. The opening 50 of the patient connector 16 is wider than the passageway 46, with the body 22 of the first portion 12 of the membrane 10 extending from the first end 42 of the body 40 and the flange 28 of the first portion 12 disposed within the opening 50. The body 30 of the second portion 14 of the membrane 10 is disposed within the passageway 46, and the flange 36 of the second portion 14 is disposed within the opening 50. The body 40 of the patient connector 16 includes a locking extension 52 at the first end 42 of the body 40, the locking extension 52 extending radially inward and configured to secure the membrane 10 to the body 40 of the patient connector 16. The patient connector 16 also includes a locking arrangement 54 configured to secure the patient connector 16 to the syringe adapter 18.

[0020] In a further aspect or embodiment, closed fluid transfer system 58 includes patient connector 16 and syringe adapter 18, although system 58 may also include other components of a closed transfer device or system. Syringe adapter 18 includes housing 60 having syringe adapter membrane 62 received therein, and cannula 20. As shown in FIG. 4 , when patient connector 16 is disposed within housing 60 of syringe adapter 18, syringe adapter membrane 62 is movable from a first position within housing 60 of syringe adapter 18 to a second position within housing 60. Membrane 10 of patient connector 16 is configured to engage syringe adapter membrane 62. When patient connector 16 is disposed within housing 60 of syringe adapter 18, cannula 20 is configured to pierce membrane 10 of patient connector 16. Syringe adapter membrane 62 is received by collet 64, although other suitable arrangements may be utilized. Syringe adapter 18 includes a luer connector 66 configured to be secured to a syringe barrel. The operation of syringe adapter 18 is described in U.S. Patent Application Publication No. 2015 / 0297454.

[0021] While the present disclosure has been described as having an exemplary design, 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. Further, this application is intended to cover such departures from the present disclosure as come within known or customary practice in the art to which the disclosure pertains and fall within the scope of the appended claims. To the extent possible, one or more features of any aspect or embodiment described above may be combined with one or more features of any other aspect or embodiment.

Claims

1. 1. A membrane for a closed transfer device, comprising: a first portion including a first material; a second portion comprising a second material, the first material having different material properties than the second material, the first portion configured to prevent leakage therethrough when the first portion is pierced by a cannula for a first predetermined time period, and the second portion configured to prevent leakage therethrough when the second portion is pierced by the cannula for a second predetermined time period, the first predetermined time period being longer than the second predetermined time period; Equipped with the first portion includes a body having a first side and a second side disposed opposite the first side, the first portion having a flange portion extending from the body; the second portion includes a body having a first side and a second side disposed opposite the first side, the second portion having a flange extending from the body; the flange portion of the first portion abuts the flange portion of the second portion such that the flange portion of the first portion and the flange portion of the second portion separate the body of the first portion and the body of the second portion; The membrane, wherein the first side of the first portion and the first side of the second portion at least partially face an external environment.

2. The membrane of claim 1 , wherein the first material comprises a thermoplastic elastomer.

3. The membrane of claim 1 or 2, wherein the second material comprises polyisoprene.

4. The membrane of claim 1 , wherein the first predetermined time is greater than or equal to 1 hour and less than or equal to 24 hours.

5. The membrane of claim 1 , wherein the second predetermined time is 10 seconds or less.

6. The membrane of claim 1 , wherein the first portion and the second portion are separately molded.

7. The membrane of claim 1 , wherein the first portion and the second portion are integrally molded.

8. a patient connector, a body having a first end and a second end and defining a passageway; a line connection portion disposed at the second end of the body; a membrane according to any one of claims 1 to 7 disposed at the first end of the body; a patient connector comprising:

9. The patient connector of claim 8 , wherein the membrane is received in an opening defined by the body.

10. 10. The patient connector of claim 9, wherein the opening is wider than the passageway, the body of the first portion extends from the first end of the body, the flange portion of the first portion is disposed within the opening, the body of the second portion is disposed within the passageway, and the flange portion of the second portion is disposed within the opening.

11. 11. The patient connector of claim 10, wherein the body of the patient connector includes a fixation extension at the first end of the body, the fixation extension extending radially inward and configured to fix the membrane to the body.

12. 1. A closed fluid transfer system comprising: A patient connector according to any one of claims 8 to 11; a syringe adapter including a housing having a syringe adapter membrane contained within the housing and a cannula, the syringe adapter membrane being movable from a first position within the housing of the syringe adapter to a second position within the housing when the patient connector is disposed within the housing of the syringe adapter; Equipped with a cannula configured to pierce the membrane of the patient connector when the patient connector is disposed within the housing of the syringe adapter;

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