Split septum needleless connector and post needleless connector using sleeve septum fusion concept

Abstract

A fluid connector assembly that provides neutral fluid displacement is disclosed. The fluid connector assembly may include a first member and a second member. A deformable sleeve is positioned on a post of the second member. A septum is positioned in an opening in the first member. The first member and the second member each include an opening. The sleeve can seal the opening in the post from fluid intrusion. However, when the post of the second member is inserted into the first member, the septum of the first member displaces the sleeve of the second member, causing the sleeve to open the opening. Furthermore, the septum seals each of the first member and the second member, and the displaced sleeve forms a fluid path through the first and second members with the sleeve regulating fluid flow.

Description

[Technical Field]

[0001] The present disclosure relates generally to medical fluid connectors, and more particularly to a neutral displacement needleless connector that reduces the incidence of dislodgement of an intravenous (IV) catheter connected to a patient. [Background technology]

[0002] Medical procedures often involve the infusion of medical fluids (e.g., saline or medicinal solutions) into a patient using an intravenous (IV) catheter connected to a fluid source, such as an IV bag, through an arrangement of flexible tubing and fittings commonly referred to as an “IV set.” Often, the tubing or catheter is linked or secured to one another to allow fluid communication between various portions of the tubing or catheter.

[0003] Needleless connectors, including neutral displacement needleless connectors, offer a solution for delivering medical fluids to a patient. In an exemplary embodiment, the needleless connector assembly facilitates fluid transfer between a medical fluid source and a catheter line. The medical fluid source and catheter line are secured to their respective luers. To deliver fluid, the luer connected to the medical fluid source overlaps the center post of the luer connected to the catheter line.

[0004] In some applications, such tubing or catheters can become dislodged due to improper fixation and / or if the needleless connector is subjected to forces greater than those for which the connection is designed to be maintained. Summary of the Invention [Problem to be solved by the invention]

[0005] In accordance with at least some embodiments disclosed herein, it is recognized that components used with neutral fluid displacement, such as luers and posts, can break if they overlap and contact one another, which can result in leakage of medical fluids and reduced delivery of medication to the patient. If the broken component is located in the connector body, it may not be readily apparent to medical personnel, leading to delayed response. [Means for solving the problem]

[0006] Aspects of the present disclosure provide a needleless fluid connector assembly that provides a neutral fluid displacement connection while minimizing the risk of damaging one or more components of the needleless fluid connector assembly. The neutral fluid displacement limits or prevents fluid from entering the catheter lumen during connection or disconnection of medical fluids.

[0007] Accordingly, an aspect of the present disclosure provides a fluid connector assembly comprising: a first member having a first end with a first opening for receiving a medical fluid, a second end opposite the first end with a second opening, and an internal volume fluidly connecting the first opening and the second opening, and a septum disposed within the second opening and preventing the medical fluid from passing through the septum; and a second member having a first end with a post, a second end opposite the first end with an outlet, at least one hole extending through the post proximate to the proximal end of the post, and a sleeve covering the hole in a covered configuration and exposing the hole in an uncovered configuration, wherein the septum receives the post in a coupled configuration, and the septum moves the sleeve from the sealed configuration to the unsealed configuration in the coupled configuration, thereby fluidly connecting the first opening and the outlet.

[0008] Some examples of the present disclosure provide a method for regulating delivery of a medical fluid, the method including the steps of: providing a first member by a fluid connector assembly, the first member having an internal volume fluidly connecting a proximal end and a distal end of the first member; receiving the medical fluid at an opening at the proximal end of the first member; receiving a septum at the distal end of the first member, the septum preventing the medical fluid from passing through the septum; receiving a second member at the septum, the second member having a post and a hole extending through the post; receiving a sleeve at the post that covers the hole in a sealing configuration and exposes the hole in an open configuration; and forming a fluid pathway that allows medical fluid entering the proximal end of the first member to pass through the hole based on displacement of the sleeve by the septum to the open configuration.

[0009] Thus, the present application addresses several operational challenges faced with prior neutral displacement connector assemblies that are prone to breaking or becoming detached from the patient.

[0010] Additional features and advantages of the subject technology will be set forth in the description which follows, and in part will be obvious from the description, or may be learned by practice of the subject technology. The advantages of the subject technology will be realized and attained by the structure particularly pointed out in the written description and examples herein, as well as the accompanying drawings.

[0011] It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory and are intended to provide further explanation of the subject technology.

[0012] Various features of exemplary embodiments of the present invention are described below with reference to the drawings. The illustrated embodiments are intended to illustrate, but not limit, the present invention. The drawings include the following figures: [Brief explanation of the drawings]

[0013] [Figure 1]FIG. 1 illustrates an IV set connected to a patient, according to an embodiment of the present disclosure. [Figure 2] FIG. 1 is an exploded view of a fluid connector assembly for use with an IV set, according to an embodiment of the present disclosure. [Figure 3] FIG. 1 is a partial cross-sectional view of a fluid connector assembly showing a first member and a second member according to an embodiment of the present disclosure. [Figure 4] FIG. 1 is a partial cross-sectional view of a fluid connector assembly showing a second member inserted into a first member, according to an embodiment of the present disclosure. [Figure 5] 1 is a flow chart illustrating a method for adjusting intravenous fluid according to an aspect of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0014] In the following detailed description, numerous specific details are set forth in order to provide a thorough understanding of the subject technology. It should be understood that the subject technology may be practiced without some of these specific details. In other instances, well-known structures and techniques have not been shown in detail in order to avoid obscuring the subject technology.

[0015] Furthermore, while the present description sets forth specific details of various embodiments, it will be appreciated that the description is illustrative only and should not be construed as limiting in any way. In addition, while particular embodiments of the present disclosure may be disclosed or illustrated in the context of an IV set, it is contemplated that such embodiments may be used in other fluid delivery systems. Still further, various applications of and modifications to such embodiments that may occur to those skilled in the art are also encompassed by the general concepts described herein.

[0016] According to several embodiments, the present disclosure includes various features and advantages that maintain separation between the post and the luer, thus minimizing the possibility of damaging the post and / or the luer.

[0017] Referring now to the figures, Figure 1 illustrates an IV set 1 connected to a patient 10 according to an embodiment of the present disclosure. The IV set 1 includes a medical fluid bag 12, a drip chamber 14, and tubing 22. The tubing 22 extends between the drip chamber 14 of the IV set 1 and a fluid connector assembly 100. To resist unintentional removal or disconnection of the tubing 16 or catheter 18 from the patient, a tape 26 is placed across the tubing 16 and catheter 18 such that the tape 26 engages the tubing 16, catheter 18, and patient 10.

[0018] 2 illustrates an exploded view of a fluid connector assembly 100 for use with an IV set according to an embodiment of the present disclosure. The fluid connector assembly 100 is designed for use in medical applications such as, by way of non-limiting example, an IV set 1 (shown in FIG. 1) using catheters, including peripheral intravenous catheters (PIVCs), as well as other IV medical fluid delivery applications.

[0019] The fluid connector assembly 100 provides a regulated fluid path throughout the components of the fluid connector assembly 100. As shown, the fluid connector assembly 100 includes a first member 102 that serves as a central body for carrying and / or connecting to one or more components. The first member 102 may include a cylindrical or generally cylindrical body. Additionally, the first member 102 may include a hollow or generally hollow body that forms an interior volume for receiving one or more components. The first member 102 may include a septum 103 at a distal end of the first member 102. The septum 103 may include a slit extending across the width of the septum 103. In some embodiments, the slit may extend partially across the width of the septum 103. The septum 103 may be generally cylindrical in shape but may be shaped to fit within an opening at an end 105 of the first member 102. First member 102 may include a protrusion 109 that extends into interior volume 124. Protrusion 109 may engage septum 103 to connect septum 103 to the distal end of first member 102.

[0020] The fluid connector assembly 100 further includes a second member 104 that can be coupled to the first member 102. As shown, the first member 102 includes an end 105 and an end 107, and the second member 104 can be coupled to the end 105. The end 105 and the end 107 may be referred to as a first end and a second end, respectively. However, "first" and "second" may be interchangeable with respect to the end 105 and the end 107. The second member 104 may also be referred to as a connector or a medical connector.

[0021] In some embodiments, first member 102 is connected to a medical fluid, such as medical fluid bag 12 (shown in FIG. 1). Additionally, in some embodiments, second member 104 is connected to a catheter line (e.g., tubing 16 in FIG. 1) that delivers medical fluid to a catheter, such as catheter 18 (shown in FIG. 1). Second member 104 may also take the form of a luer designed to prevent leakage of fluid through its connection with first member 102. In this regard, second member 104 may conform to standards established by the International Organization for Standards (ISO) to improve patient safety, minimize leakage of medical fluids, and reduce misconnections with other connecting devices.

[0022] The second member 104 includes an outlet 108, which includes a channel fluidly connected to an opening 116 at an end of the outlet 108. As a result, the outlet 108 serves as a fluid transport location for the fluid connector assembly 100. The first member 102 also includes an inlet 112, which includes an opening (not shown in FIG. 2 ). The opening of the inlet 112 serves as a fluid inlet for the fluid connector assembly 100. The opening thus serves as a fluid receiving location for the fluid connector assembly 100. Each of the outlet 108 and the inlet 112 may pass through the center, or at least approximately the center, of the end of the first member 102 and the second member 104, respectively. However, the terms “first” and “second” may be used interchangeably. Each of the outlet 108 and the inlet 112 may also include a cylindrical or generally cylindrical shape. However, other shapes are possible.

[0023] The second member 104 includes an opening 116 (shown in FIG. 3) formed in a post 110 of the second member 104. The post 110 may be generally conical in shape. In some embodiments, the post 110 is cannulated. However, other shapes are possible. The post 110 may be separated from the outlet 108 by a collar 111. The collar 111 may extend circumferentially from the junction of the post 110 and the outlet 108. The collar may be generally cylindrical in shape with a proximal end having a smaller diameter than the distal end of the collar. However, other shapes are possible. In some embodiments, the collar 111 is configured to contact the end 105 of the first member 102 when the first member 102 and the second member 104 are coupled in a coupled configuration. In some embodiments, the collar 111 is located approximately at the midpoint of the longitudinal axis of the second member 104. In some embodiments, the collar 111 is located at a point on the longitudinal axis closer to the proximal or distal end of the second member 104. In some embodiments, the collar 111 aligns the opening 116 of the post 110 within the interior volume 124 of the first member 102 in the coupled configuration. The opening 116 provides a fluid inlet for the second member 104. The opening 116 is fluidly connected to the outlet 108.

[0024] Additionally, the second member 104 includes a sleeve 113. The sleeve 113 may cover the opening 116 to prevent fluid from entering the second member 104. The sleeve 113 may extend around the post 110, or in some embodiments, may cover only the opening 116. The sleeve 113 may be made of silicone or another suitable rubber, plastic, or other material. The sleeve 113 may be secured to the post 110 at its distal end, while the proximal end of the sleeve 113 is free to slide relative to the post 110. Thus, the sleeve 113 is movable and can be compressed or bent by an external force (or forces) and then return to its original, uncompressed state when an opposing external force is applied. The sleeve 113 is designed to regulate the flow of fluid through the second member 104. Thus, the sleeve 113 functions as a valve for the fluid connector assembly 100, as will be described in more detail below.

[0025] 3 illustrates a partial cross-sectional view of the fluid connector assembly 100 showing the first member 102 and the second member 104, according to an embodiment of the present disclosure. Based on its hollow design, the first member 102 includes an interior volume 124 that forms a three-dimensional space or void in the first member 102, thus allowing the first member 102 to receive one or more components. For example, the post 110 of the second member 104 may be positioned in the interior volume 124 when the fluid connector assembly 100 is in the coupled configuration. The first member 102 further includes an interior surface 126, or wall, that at least partially defines the interior volume 124 of the first member 102.

[0026] Additionally, post 110 includes an interior volume 128 through which a portion of outlet 108 is disposed. Post 110 further includes an interior surface 130, or wall, that at least partially defines interior volume 128 of post 110. Also shown in FIG. 3 , interior surface 130 of post 110 mates with outlet 108 at collar 111. Sleeve 113 prevents fluid flow through opening 116.

[0027] The septum 103 includes a slit 117, or opening, that separates based on an applied force. As shown in FIG. 3 , the slit 117 can be closed, resisting fluid flow therethrough. However, when the second member 104 is coupled to the first member 102, the post 110 of the second member 104 engages the septum 103, causing the slit 117 to open based on an applied force exerted by the post 110. In some embodiments, the septum forms a seal between the post 110 and the first member 102, preventing leakage of fluid between the post 110 and the first member 102.

[0028] Additionally, sleeve 113 includes dimension 136 that defines the longitudinal dimension of the major axis of sleeve 113. When no external force is acting on sleeve 113 to displace (e.g., compress) sleeve 113, the longitudinal dimension of sleeve 113 is defined by dimension 136. Thus, dimension 136 of sleeve 113 represents an initial dimension, and the size and shape of sleeve 113 shown in FIG. 3 represent the initial size and shape.

[0029] FIG. 4 illustrates a partial cross-sectional view of a fluid connector assembly 100 showing a second member 104 inserted into a first member 102, according to an embodiment of the present disclosure. As shown, a post 110 of the second member 104 is at least partially disposed in the first member 102 and engages the septum 103, causing a slit 117 in the septum 103 to open. Additionally, the septum 103 engages the sleeve 113, causing a proximal end of the sleeve 113 to shift toward the distal end of the sleeve 113. In some embodiments, a protrusion 109 received within the septum 103 provides the septum 103 with the necessary integrity to shift the sleeve 113 when the post 110 is disposed in the first member 102. In some embodiments, the sleeve 113 bends at a point between the proximal and distal ends of the sleeve 113. In some embodiments, the sleeve 113 bends upon engagement with the septum 103. In some embodiments, septum 103 includes a cavity 106 between the proximal and distal ends of the longitudinal axis of septum 103. In some embodiments, cavity 106 can be located between a portion configured to receive protrusion 109 and a portion at end 105 of first member 102. Cavity 106 can allow sleeve 113 to move radially without resistance when septum 103 engages sleeve 113.

[0030] For example, sleeve 113 compresses, reducing to dimension 138, which is smaller than dimension 136 (the original, uncompressed dimension shown in FIG. 3 ). Furthermore, the displacement of sleeve 113 causes opening 116 in post 110 to open. As a result, fluid passing through interior volume 124 can further pass through opening 116 in post 110. Thus, in the open configuration of sleeve 113, outlet 108 is fluidly connected to inlet 112. When sleeve 113 is compressed to dimension 138, the proximal end of sleeve 113 can engage the septum and prevent second member 104 from disengaging from first member 102. In some embodiments, sleeve 113 can prevent separation of second member 104 from first member 102 up to a force of 8 pounds. In some embodiments, the force can be between 3 pounds and 8 pounds. In some embodiments, the force may be between 3 and 5 pounds, and in some embodiments, the force may be approximately 4 pounds. In some embodiments, the force may be less than approximately 3 pounds or greater than approximately 5 pounds. This separation may allow the fluid connector assembly 100 to prevent unintentional removal or disconnection of the tubing 16 or catheter 18 from the patient.

[0031] The dotted arrows indicate the fluid path through the fluid connector assembly 100. When a medical fluid line is connected to the first member 102, the fluid enters the inlet 112 (i.e., the fluid inlet) of the first member 102. The fluid can then pass through the channel 144 of the inlet 112 and enter the interior volume 124 of the first member 102. The fluid can then enter the opening 116 of the post 110 into the interior volume 128 and then pass through the channel 146 of the outlet 108. The fluid can exit the fluid connector assembly 100 through the outlet 108.

[0032] Based on the flow of fluid through the fluid connector assembly 100, the fluid connector assembly 100 provides a neutral fluid displacement in which blood and / or other fluids are prevented, or at least substantially limited, from entering a catheter lumen (not shown) located in the second member 104 and fluidly connected to the fluid connector assembly 100 during connection or disconnection between the fluid connector assembly 100 and a catheter lumen, or when a medical fluid line is connected to or disconnected from the first member 102. Based on the features and functionality, the fluid connector assembly 100, unlike a positive fluid displacement connector assembly, does not force fluid into the catheter lumen during connection or disconnection. Also, unlike a negative fluid displacement connector assembly, the fluid connector assembly 100 does not allow fluid to flow back into the catheter lumen during connection or disconnection. Thus, the fluid connector assembly 100 comprises a neutral displacement connector assembly.

[0033] When second member 104 is removed from first member 102, according to an aspect of the present disclosure, septum 103 engages the proximal end of sleeve 113 and moves it away from the distal end of sleeve 113, returning sleeve 113 to its original shape and size. In this regard, sleeve 113 returns to having dimension 136, which represents the original longitudinal dimension of sleeve 113 before displacement by septum 103. Furthermore, slit 117 in septum 103 closes after post 110 is removed, preventing the passage of fluid therethrough. Additionally, sleeve 113 covers opening 116 in post 110, again sealing opening 116.

[0034] 5 illustrates a flow chart 300 showing a method for regulating delivery of a medical fluid according to an embodiment of the present disclosure. The fluid connector assemblies shown or described herein are capable of performing the method steps shown in flow chart 300. In this regard, a fluid connector assembly using neutral fluid displacement may perform the method steps shown in flow chart 300.

[0035] In step 302, a first member is provided. The first member serves as a central body of the fluid connector assembly. The housing has a proximal end and a distal end and may include an interior volume designed to receive, or at least partially receive, one or more components of the fluid connector assembly.

[0036] In step 304, a medical fluid is received at an opening in the proximal end of the first member.

[0037] In step 306, a septum is received in the opening in the distal end of the first member. The septum may include a slit extending therethrough. The septum may prevent medical fluid from passing therethrough.

[0038] In step 308, a second member is received in the septum. The second member is further received through the septum into the interior volume of the first member. The second member includes a post extending proximally therefrom, the post opening a slit in the septum. The post includes a hole extending therethrough adjacent the proximal end of the post.

[0039] In step 310, a sleeve is received on the post. The sleeve is configured to cover the hole in a sealed configuration and expose the hole in an open configuration. A distal end of the sleeve is coupled to the post, and a proximal end of the sleeve is movable relative to the post, thereby reducing the dimension (e.g., length) of the sleeve in response to a force acting on the sleeve. However, due to the elastic characteristics of the sleeve, the sleeve can return to its original size and shape when an opposing force is applied thereto. In step 312, a seal is formed upon displacement of the sleeve to the open configuration. The seal creates a fluid path for medical fluid to pass through the holes in the posts of the second connector. Additionally, the seal promotes neutral fluid displacement by restricting or preventing blood and / or other fluids from entering the catheter lumen when connection or disconnection with the fluid connector assembly occurs.

[0040] A feature of the present disclosure provides a fluid connector assembly having a sleeve that can be displaced to form a fluid pathway therebetween. When the first and second members are coupled together, the sleeve can be displaced to allow fluid flow. However, when the member displacing the sleeve is separated from the second member, either unintentionally or intentionally, the fluid pathway of the fluid connector assembly closes or is blocked to prevent fluid loss therefrom as the sleeve returns to an uncompressed state, closing the fluid pathway. A feature of the present disclosure also provides that upon separation of the first and second members, either the first or second members can be cleaned and sterilized, and the first and second members can be recoupled together so that the sleeve forms a fluid pathway therebetween.

[0041] Examples of subject matter art as clauses The subject technology is exemplified by various aspects described below, for example. Various examples of aspects of the subject technology are described as numbered clauses (1, 2, 3, etc.) for convenience. These are provided as examples and do not limit the subject technology. Note that any of the dependent clauses may be combined in any combination and incorporated into a respective independent clause, e.g., clause 1, clause 8, or clause 15. Other clauses may be presented similarly.

[0042] Clause 1. A fluid connector assembly comprising: a first member having a first end with a first opening for receiving a medical fluid, a second end opposite the first end with a second opening, and an internal volume fluidly connecting the first opening and the second opening, and a septum disposed within the second opening to prevent the medical fluid from passing therethrough; and a second member having a first end with a post, a second end opposite the first end with an outlet, at least one hole extending through the post adjacent to the proximal end of the post, and a sleeve covering the hole in a sealing configuration and exposing the hole in a release configuration, wherein the septum receives the post in a coupled configuration, and the septum moves the sleeve from the sealing configuration to the release configuration in the coupled configuration, thereby fluidly connecting the first opening and the outlet.

[0043] Clause 2. A fluid connector assembly as described in clause 1, wherein the proximal end of the sleeve is bent toward the distal end of the sleeve in the released configuration.

[0044] Clause 3. A fluid connector assembly as described in clause 2, wherein the sleeve engages the proximal end of the septum in the released configuration to resist separation of the first member and the second member.

[0045] Clause 4. The fluid connector assembly of clause 3, wherein the sleeve resists separation of the first member and the second member to a force of between 1.36 kg (3 lbs) and 2.27 kg (5 lbs).

[0046] Clause 5. A fluid connector assembly as described in clause 1, wherein the second member further comprises a collar at the base of the post for aligning the internal volume and the bore in the coupled configuration.

[0047] Clause 6. A fluid connector assembly as described in clause 5, wherein the second end of the first member is generally planar and engages with the collar of the second member in the coupled configuration.

[0048] Clause 7. A fluid connector assembly as described in clause 1, wherein the sleeve is configured to cover the hole when the first member and the second member are separated.

[0049] Clause 8. The fluid connector assembly of clause 1, wherein the septum includes a slit extending at least partially across the width of the septum.

[0050] Clause 9. The fluid connector assembly of clause 1, wherein the sleeve extends circumferentially around the post.

[0051] Clause 10. The fluid connector assembly of clause 1, wherein the sleeve covers only a portion of the post that defines the hole.

[0052] Clause 11. The fluid connector assembly of clause 1, wherein the post is generally conical in shape.

[0053] Clause 12. A fluid connector assembly as described in clause 1, wherein the first member is a generally cylindrical side surface.

[0054] Clause 13. The fluid connector assembly of clause 1, wherein the post is a post.

[0055] Clause 14. A fluid connector assembly as described in clause 1, wherein the interior volume comprises a protrusion configured to couple the septum to an inner surface of the first member.

[0056] Clause 15. A method for regulating delivery of a medical fluid, the method comprising the steps of: providing a first member by a fluid connector assembly, the first member having an interior volume fluidly connecting a proximal end and a distal end of the first member; receiving the medical fluid at an opening at the proximal end of the first member; receiving a septum at the distal end of the first member that prevents the medical fluid from passing therethrough; receiving a second member in the septum, the second member having a post and a hole extending through the post; receiving a sleeve in the post that covers the hole in a sealing configuration and exposes the hole in an open configuration; and forming a fluid pathway that allows medical fluid entering the proximal end of the first member in a coupled configuration to pass through the hole based on displacement of the sleeve by the septum to the open configuration.

[0057] Clause 16. The method of clause 15, wherein the septum includes a slit, and the step of receiving the second member includes extending a post through the slit in the septum.

[0058] Clause 17. The method of clause 16, wherein the step of receiving the second member includes bending the proximal end of the sleeve toward the distal end of the sleeve.

[0059] Clause 18. The method of clause 17, wherein the step of maintaining the coupled configuration includes a sleeve engaging a proximal end of the septum to resist separation of the first member and the second member.

[0060] Clause 19. The method of clause 15, wherein the distal end of the first member has a generally planar surface, the second member includes a collar at the distal end of the post, and the step of receiving the second member is prevented when the collar engages the distal end of the first member.

[0061] Clause 20. The method of clause 15, wherein the step of separating the first member and the second member includes the sleeve returning to a sealing configuration and the septum preventing the medical fluid from passing through the septum.

[0062] Further Considerations In some embodiments, any of the clauses herein may depend on any one of the independent clauses or any one of the dependent clauses. In one aspect, any of the clauses (e.g., dependent or independent clauses) may be combined with any one or more other clauses (e.g., dependent or independent clauses). In one aspect, a claim may include some or all of the words (e.g., steps, actions, means, or components) recited in a clause, sentence, phrase, or paragraph. In one aspect, a claim may include some or all of the words recited in one or more clauses, sentences, phrases, or paragraphs. In one aspect, some of the words in each clause, sentence, phrase, or paragraph may be removed. In one aspect, additional words or elements may be added to a clause, sentence, phrase, or paragraph. In one aspect, the subject technology may be implemented without utilizing some of the components, elements, functions, or operations described herein. In one aspect, the subject technology may be implemented using additional components, elements, functions, or operations.

[0063] This disclosure is provided to enable any person skilled in the art to practice the various aspects described herein. While this disclosure provides various examples of the subject technology, the subject technology is not limited to these examples. Various modifications to these aspects will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other aspects.

[0064] Reference to a singular element is not intended to mean "one and only one" unless specifically so stated, but rather "one or more." The term "some" refers to one or more unless specifically stated otherwise. Masculine pronouns (e.g., his) include feminine and neuter pronouns (e.g., her and its), and vice versa. Headings and subheadings, if present, are used for convenience only and do not limit the invention.

[0065] The word "exemplary" is used herein to mean "serving as an example or illustration." Any aspect or design described herein as "exemplary" is not necessarily to be construed as preferred or advantageous over other aspects or designs. In one aspect, various alternative configurations and operations described herein may be considered at least equivalent.

[0066] The use of a phrase such as "aspect" does not imply that such aspect is essential to the subject technology or that such aspect applies to all configurations of the subject technology. Disclosure of an aspect may apply to all configurations, or to one or more configurations. An aspect may provide one or more examples. A phrase such as "aspect" may refer to one or more aspects, and vice versa. A phrase such as "embodiment" does not imply that such embodiment is essential to the subject technology or that such embodiment applies to all configurations of the subject technology. Disclosure of an embodiment may apply to all embodiments, or to one or more examples. An embodiment may provide one or more examples. A phrase such as "embodiment" may refer to one or more embodiments, and vice versa. A phrase such as "configuration" does not imply that such embodiment is essential to the subject technology or that such embodiment applies to all configurations of the subject technology. Disclosure of a configuration may apply to all configurations, or to one or more configurations. A configuration may provide one or more examples. A phrase such as a configuration may refer to one or more configurations, and vice versa.

[0067] In one aspect, unless otherwise stated, all measurements, values, estimates, locations, dimensions, sizes, and other specifications set forth in this specification, including the following claims, are approximate and not precise, and are intended to have a reasonable range consistent with the function to which they relate and with that which is customary in the art to which they pertain.

[0068] In one aspect, the term "coupled" or the like can refer to being directly coupled. In another aspect, the term "coupled" or the like can refer to being indirectly coupled.

[0069] As used in this disclosure, terms such as "upper," "lower," "front," "rear," etc., should be understood to refer to any frame of reference other than the typical gravity-based frame of reference. Thus, upper, lower, front, and rear surfaces may extend upward, downward, diagonally, or horizontally in a gravity-based frame of reference.

[0070] Various items may be arranged differently (e.g., placed in a different order or divided in a different manner) without departing from the scope of the subject technology. All structural and functional equivalents to the elements of the various aspects described throughout this disclosure that are known or later become known to those of ordinary skill in the art are expressly incorporated herein by reference and are intended to be encompassed by the claims. Furthermore, nothing disclosed herein is intended to be made available to the public, regardless of whether such disclosure is expressly recited in the claims. No claim element is to be construed under the provisions of 35 U.S.C. § 112, paragraph 6, unless the element is expressly recited using the phrase "means for," or, in the case of a method claim, unless the element is recited using the phrase "step for." Still further, with respect to the use of the terms "comprising," "having," and the like, such terms are intended to be inclusive in the same manner as "comprising," as the term "comprising" is interpreted when used as a transitional phrase in a claim.

[0071] The Title, Background, Summary, Brief Description of the Drawings, and Abstract of this Disclosure are hereby incorporated into this disclosure and are provided as illustrative examples of the disclosure, not as a limiting description. This disclosure is submitted with the understanding that they will not be used to limit the scope or meaning of the claims. Additionally, in the Detailed Description, it may be recognized that the description provides exemplary illustrations, and that various features are grouped together in various embodiments for the purpose of streamlining the disclosure. This method of disclosure is not to be interpreted as reflecting an intention that the claimed subject matter requires more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive subject matter lies in less than all features of a single disclosed structure or operation. The following claims are hereby incorporated into the Detailed Description, with each claim standing on its own as separately claimed subject matter.

[0072] The claims are not intended to be limited to the embodiments described herein, but are to be accorded the full scope consistent with the claims as written and to encompass all legal equivalents. Nevertheless, no claim is intended to, and should not be construed to, encompass subject matter that does not satisfy the requirements of 35 U.S.C. §§ 101, 102, or 103.

Claims

1. 1. A fluid connector assembly comprising: a first end having a first opening for receiving a medical fluid; a second end opposite the first end, the second end including a second opening; and an interior volume fluidly connecting the first opening and the second opening; and a septum disposed within the second opening to prevent medical fluid from passing therethrough; a first member comprising: a first end comprising a post; a second end opposite the first end, the second end including an outlet; at least one hole extending through said post; and a sleeve movable relative to the post that covers the hole in a covered configuration and exposes the hole in an uncovered configuration; a second member comprising: Equipped with the bulkhead receives the post in a mating configuration; the septum moves the sleeve in the coupled configuration from the sealed configuration to the released configuration, thereby fluidly connecting the first opening and the outlet. Fluid connector assembly.

2. The fluid connector assembly of claim 1 , wherein the proximal end of the sleeve is displaced toward the distal end of the sleeve in the released configuration.

3. 3. The fluid connector assembly of claim 2, wherein the sleeve engages the proximal end of the septum in the released configuration to resist separation of the first and second members.

4. 4. The fluid connector assembly of claim 3, wherein the sleeve resists separation of the first and second members in the released configuration up to a force of between 3 and 5 pounds.

5. 2. The fluid connector assembly of claim 1, wherein the second member further comprises a collar at the base of the post that aligns the interior volume and the bore in the coupled configuration.

6. 6. The fluid connector assembly of claim 5, wherein the second end of the first member is generally planar and engages the collar of the second member in the coupled configuration.

7. The fluid connector assembly of claim 1 , wherein the sleeve is configured to cover the hole when the first and second members are separated.

8. 2. The fluid connector assembly of claim 1, wherein the septum includes a slit extending at least partially across the width of the septum.

9. The fluid connector assembly of claim 1 , wherein the sleeve extends circumferentially around the post.

10. The fluid connector assembly of claim 1 , wherein the sleeve covers only a portion of the post that defines the hole.

11. The fluid connector assembly of claim 1 , wherein the post is generally conical in shape.

12. 2. The fluid connector assembly of claim 1, wherein the first member is a generally cylindrical side.

13. The fluid connector assembly of claim 1 , wherein the post is a cannula.

14. The fluid connector assembly of claim 1 , wherein the interior volume comprises a protrusion configured to couple the septum to an interior surface of the first member.

15. 1. A method for regulating delivery of a medical fluid by a fluid connector assembly, comprising: providing a first member, the first member having an interior volume fluidly connecting a proximal end and a distal end of the first member; receiving the medical fluid at an opening in the proximal end of the first member; receiving a septum at the distal end of the first member that prevents the medical fluid from passing therethrough; receiving a second member in the bulkhead, the second member comprising a post and a hole extending through the post; receiving a sleeve on the post that covers the hole in a closed configuration and exposes the hole in an open configuration; and forming a fluid pathway through the hole for the medical fluid entering the proximal end of the first member in a coupled configuration based on displacement of the sleeve by the septum to the released configuration; A method comprising:

16. the partition wall has a slit; the step of receiving the second member includes the post extending through the slit in the septum.

16. The method of claim 15.

17. The method of claim 16, wherein the step of receiving the second member includes bending a proximal end of the sleeve toward a distal end of the sleeve.

18. 18. The method of claim 17, wherein maintaining the coupled configuration includes the sleeve engaging a proximal end of the septum to resist separation of the first and second members.

19. the distal end of the first member has a generally planar surface; the second member includes a collar at a distal end of the post; the step of receiving the second member is prevented when the collar engages the distal end of the first member.

16. The method of claim 15.

20. 16. The method of claim 15, wherein separating the first member and the second member includes returning the sleeve to the sealing configuration and the septum preventing the medical fluid from passing through the septum.

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