Membrane for closed system transfer device

Abstract

A film for a closed system transfer device, the film comprising a first portion and a second portion, the first portion comprising a first material and the second portion comprising a second material. The first material has different material properties than the second material. The first portion is configured to prevent leakage through the first portion when the first portion is pierced by a cannula for a first predetermined amount of time, and the second portion is configured to prevent leakage through the second portion when the second portion is pierced by the cannula for a second predetermined amount of time. The first predetermined amount of time is greater than the second predetermined amount of time.

Description

[0001] Cross-reference to related applications

[0002] This application claims priority to U.S. Provisional Application No. 63 / 070,020, filed on August 25, 2020, entitled “Membrane for Closed System Transfer Device,” the entire disclosure of which is incorporated herein by reference.

[0003] Background Art of the Invention

[0004] This disclosure of the field

[0005] This disclosure generally relates to a membrane for a closed system transfer device.

[0006] Description of related technologies

[0007] Healthcare providers who reconstitute, transport, and administer hazardous drugs (e.g., cancer treatments) may expose themselves to these drugs and pose a hazard to the healthcare environment. Inadvertent chemotherapy exposure can affect the nervous system, damage the reproductive system, and increase the risk of future blood cancers. Some drugs must be dissolved or diluted before administration, which involves transferring the solvent from a container to a sealed vial containing the drug in powder or liquid form via a needle. If any pressure difference exists between the inside of the vial and the surrounding atmosphere, the drug may be inadvertently released into the atmosphere as a gas or via atomization during needle removal from the vial, and while the needle is inside the vial. To reduce the risk of healthcare providers' exposure to toxic drugs, closed-system transfer devices or systems are used to transfer these drugs.

[0008] Closed-system transfer devices or systems may use membranes to ensure the safe transfer of fluid between components. For example, a syringe adapter may include a membrane that contacts a mating component (e.g., a patient connector, an intravenous injection (IV) bag spike, or a vial adapter). Summary of the Invention

[0009] In one aspect or embodiment, a membrane for a closed system transfer device includes a first portion having a first material and a second portion having a second material, wherein the first material has different material properties than the second material. The first portion is configured to prevent leakage through the first portion when the first portion is punctured by a cannula for a first predetermined time amount, and the second portion is configured to prevent leakage through the second portion when the second portion is punctured by a cannula for a second predetermined time amount. The first predetermined time amount is greater than the second predetermined time amount.

[0010] The first material may be a thermoplastic elastomer. The second material may be polyisoprene. The first predetermined time may be one hour or longer. The second predetermined time may be 10 seconds or less. The first part and the second part may be formed separately or integrally. The first part includes a body having a first side and a second side positioned opposite to the first side, wherein the first part has a flange extending from the body. The second part includes a body having a first side and a second side positioned opposite to the first side, wherein the second part has a flange extending from the body. The flange of the first part may abut against the flange of the second part.

[0011] In another aspect or embodiment, a patient connector includes: a body having a first end and a second end, wherein the body defines a channel; a conduit connector located at the second end of the body; and a membrane according to any one of the aspects or embodiments discussed above, wherein the membrane is positioned at the first end of the body of the patient connector.

[0012] The membrane can be received by an opening defined by the body of the patient connector. This opening may be wider than the channel, wherein a first portion of the body extends from a first end of the patient connector body, a flange of the first portion is positioned within the opening, and a second portion of the body is positioned within the channel, with a flange of the second portion also positioned within the opening. The body of the patient connector may include a retaining extension located at the first end of the patient connector body, wherein the retaining extension extends radially inward and is configured to secure the membrane to the body of the patient connector.

[0013] In another aspect or embodiment, a system for closed-loop transfer of fluid includes: a patient connector according to any one of the aspects or embodiments discussed above; and a syringe adapter having a housing and a cannula, the housing having a syringe adapter membrane housed within the housing. When the patient connector is positioned within the housing of the syringe adapter, the syringe adapter membrane is movable from a first position within the housing of the syringe adapter to a second position within the housing. The membrane of the patient connector is configured to engage the syringe adapter membrane. The cannula is configured to puncture the membrane of the patient connector when the patient connector is positioned within the housing of the syringe adapter. Attached Figure Description

[0014] The above and other features and advantages of this disclosure, as well as the ways in which they are obtained, will become more apparent from the following description of various aspects of this disclosure in conjunction with the accompanying drawings, and the disclosure itself will be better understood.

[0015] Figure 1This is a front view of a patient connector according to one aspect or embodiment of this application.

[0016] Figure 2 yes Figure 1 A cross-sectional view of the patient connector.

[0017] Figure 3 yes Figure 1 A cross-sectional view of the patient connector, showing the patient connector inserted into the syringe adapter.

[0018] Figure 4 yes Figure 1 A cross-sectional view of the patient connector, showing the patient connector inserted into the syringe adapter.

[0019] In all views of the multiple views, corresponding reference numerals refer to corresponding parts. The examples set forth herein illustrate exemplary aspects of this disclosure, and these examples should not be construed as limiting the scope of this disclosure in any way. Detailed Implementation

[0020] The following description is provided to enable those skilled in the art to make and use the aspects contemplated for carrying out the invention. However, various modifications, equivalents, variations, and substitutions will be apparent to those skilled in the art. Any and all such modifications, variations, equivalents, and substitutions are intended to fall within the spirit and scope of the invention.

[0021] In the following description, for purposes of description, the terms “upper,” “lower,” “right,” “left,” “vertical,” “horizontal,” “top,” “bottom,” “lateral,” “longitudinal,” and their derivatives will refer to the invention as oriented as shown in the accompanying drawings. However, it should be understood that the invention may take various alternative variations unless explicitly stated otherwise. It should also be understood that the specific devices shown in the drawings and described in the following specification are merely exemplary aspects of the invention. Therefore, specific dimensions and other physical characteristics relating to the aspects disclosed herein should not be considered limiting.

[0022] Reference Figures 1 to 4 According to one aspect or embodiment of this application, a membrane 10 for a closed system transfer device includes a first portion 12 having a first material and a second portion 14 having a second material. For example... Figure 1 and Figure 2As shown, membrane 10 is depicted as being connected to patient connector 16, which is used to connect a component of a closed-system transfer device or system to a patient's intravenous line. For example, patient connector 16 may be connected to syringe adapter 18 to facilitate the transfer of fluid from one container (e.g., syringe barrel) to another container or line (e.g., intravenous line, IV bag, or other component). Membrane 10 can be used in any component of a closed-system transfer device or system. In one aspect or embodiment, membrane 10 is used in each component that mates with syringe adapter 18, such as patient connector 16, bottle adapter, IV bag tip, etc. Syringe adapter 18 may be identical and operate in the same manner as the syringe adapter shown and described in U.S. Patent Application Publication No. 2015 / 0297454, the entire contents of which are incorporated herein by reference.

[0023] Reference Figure 1 and Figure 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 through the first portion 12 when the sleeve 20 punctures the first portion 12 for a first predetermined time amount, and the second portion 14 is configured to prevent leakage through the second portion 14 when the sleeve 20 punctures the second portion 14 for a second predetermined time amount. The first predetermined time amount is greater than the second predetermined time amount. The first material is a thermoplastic elastomer, but other suitable materials may also be used. In one aspect or embodiment, the first material may be available from Hexpol thermoplastic elastomer (TPE). Thermoplastic elastomer. The second material is polyisoprene, but other suitable materials may also be used.

[0024] In one aspect or embodiment, the first predetermined time period is one hour or longer. In one aspect or embodiment, the second predetermined time period is 10 seconds or less. In some configurations, the first predetermined time period can be about 24 hours, designed to prevent “long-term” leakage, and the second predetermined time period can be about a few seconds to one minute, designed to prevent “short-term” leakage. As described above, the membrane 10 is used in conjunction with a closed system transfer device or system, and during use, the cannula 20 of the syringe adapter 18 can puncture the membrane 10 and be quickly (e.g., for 10 seconds or less) withdrawn from the membrane. The membrane 10 can also be used in cases where the cannula 20 of the syringe adapter 18 punctures the membrane 10 and remains at the puncture site for a longer period (e.g., one hour or longer). The membrane 10 is configured to prevent leakage through the membrane 10, such as through an opening caused by the cannula 20 puncturing the membrane 10 or through leakage at the interface between the cannula 20 and the membrane 10. The first portion 12 of the membrane 10 is configured to optimize sealing performance for cases where the membrane 10 is punctured and remains punctured for the first predetermined time period. The second portion 14 of the membrane 10 is configured to optimize sealing performance for a second predetermined time period after the membrane 10 is punctured. Therefore, the membrane 10 having the first portion 12 and the second portion 14 is configured to reduce leakage in both long-term and short-term puncture cases.

[0025] In one aspect or embodiment, the first portion 12 and the second portion 14 are formed separately. Alternatively, the first portion 12 and the second portion 14 may be formed integrally. The first portion 12 includes a body 22 having a first side 24 and a second side 26 positioned opposite to the first side 24, wherein a flange 28 extends from the body 22; the second portion 14 includes a body 30 having a first side 32 and a second side 34 positioned opposite to the first side 32, wherein a flange 36 extends from the body 30. Figure 2 As shown, the flange 28 of the first portion 12 abuts the flange 36 of the second portion 14. The first portion 12 and the second portion 14 of the membrane 10 may be circular, but other suitable shapes and configurations may be used. The first portion 12 may be attached to the second portion 14 via an adhesive or any other suitable arrangement.

[0026] Refer again Figure 1 and Figure 2The patient connector 16 includes a body 40 having a first end 42 and a second end 44, wherein the body 40 defines a channel 46, a tubing connector 48 is positioned at the second end 44 of the body 40, and a membrane 10 is positioned at the first end 42 of the body 40. The tubing connector 48 may be a Luer lock connector, but other suitable connectors may also be used. 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 channel 46, wherein a body 22 of a first portion 12 of the membrane 10 extends from the first end 42 of the body 40, and a flange 28 of the first portion 12 is positioned within the opening 50. A body 30 of a second portion 14 of the membrane 10 is positioned within the channel 46, and a flange 36 of the second portion 14 is positioned within the opening 50. The body 40 of the patient connector 16 includes a retaining extension 52 located at a first end 42 of the body 40, wherein the retaining extension 52 extends radially inward and is configured to secure the membrane 10 to the body 40 of the patient connector 16. The patient connector 16 also includes a locking device 54 configured to secure the patient connector 16 to the syringe adapter 18.

[0027] In another aspect or embodiment, the system 58 for closed-loop fluid transfer includes a patient connector 16 and a syringe adapter 18, but the system 58 may also include closed-loop transfer devices or other components of the system. The syringe adapter 18 includes a housing 60 and a cannula 20, the housing having a syringe adapter diaphragm 62 housed within the housing 60. Figure 4 As shown, when the patient connector 16 is positioned within the housing 60 of the syringe adapter 18, the syringe adapter membrane 62 can move from a first position within the housing 60 of the syringe adapter 18 to a second position within the housing 60. The membrane 10 of the patient connector 16 is configured to engage the syringe adapter membrane 62. When the patient connector 16 is positioned within the housing 60 of the syringe adapter 18, the cannula 20 is configured to puncture the membrane 10 of the patient connector 16. The syringe adapter membrane 62 is received by a collet 64, but other suitable arrangements may also be used. The syringe adapter 18 includes a Luer connector 66 configured to be secured to the syringe barrel. The operation of the syringe adapter 18 is described in U.S. Patent Application Publication No. 2015 / 0297454.

[0028] While this disclosure has been described as having an exemplary design, it can be further modified within its spirit and scope. Therefore, this application is intended to cover any variations, uses, or adaptations of this disclosure using its general principles. Furthermore, this application is intended to cover such deviations from this disclosure that are within the known or conventional practices of the art to which this disclosure pertains and fall within the limitations of the appended claims. To the extent possible, one or more features of any aspect or embodiment discussed above may be combined with one or more features of any other aspect or embodiment.

Claims

1. A membrane for a closed-system transfer device, comprising: The first part includes a first material; as well as The second part includes a second material, the first material having material properties different from the second material, wherein the first part is configured to prevent leakage through the first part when the first part is punctured by the cannula for a first predetermined time, and wherein the second part is configured to prevent leakage through the second part when the second part is punctured by the cannula for a second predetermined time, the first predetermined time being greater than the second predetermined time. The first part includes a body having a first side and a second side positioned opposite to the first side, and the first part having a flange extending from the body of the first part. The second part includes a body having a first side and a second side positioned opposite the first side, and the second part having a flange extending from the body of the second part; and The flange of the first portion is adjacent to the flange of the second portion.

2. The membrane according to claim 1, wherein, The first material includes a thermoplastic elastomer.

3. The membrane according to claim 1, wherein, The second material includes polyisoprene.

4. The membrane according to claim 1, wherein, The first predetermined time is one hour or longer.

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

6. The membrane according to any one of claims 1 to 5, wherein, The first part and the second part are formed separately.

7. The membrane according to any one of claims 1 to 5, wherein, The first part and the second part are integrally formed.

8. A patient connector, comprising: A main body having a first end and a second end, the main body defining a channel; A pipeline connector, wherein the pipeline connector is positioned at the second end of the main body; as well as The membrane according to any one of claims 1 to 7 is positioned at the first end of the body of the patient connector.

9. The patient connector according to claim 8, wherein, The membrane is contained within an opening defined by the body of the patient connector.

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

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

12. A system for closed-loop transfer of fluid, comprising: The patient connector according to any one of claims 8 to 11; as well as A syringe adapter includes a housing and a cannula. The housing has a syringe adapter membrane housed within the housing. When a patient connector is positioned within the housing of the syringe adapter, the syringe adapter membrane is movable from a first position within the housing to a second position within the housing. The membrane of the patient connector is configured to engage the syringe adapter membrane, and the cannula is configured to puncture the membrane of the patient connector when the patient connector is positioned within the housing of the syringe adapter.

Images