Auto shutoff male luer fitting

Abstract

The medical connector may include a body having an outer surface and an inner surface defining a lumen of the body, an inlet port defined at a proximal end of the body and an outlet port defined at a distal end of the body. The medical connector further includes a compressible valve member having a normally closed slit disposed within the lumen and extending through the inner and outer surfaces of the body to an exterior of the medical connector. The compressible valve member may be configured to compress radially inwardly to open the slit upon insertion of the body into the medical access device and to expand radially outwardly to close the slit upon separation of the body from the medical access device.

Description

[Technical field]

[0001] This application claims priority to U.S. Provisional Patent Application No. 63 / 168,177, filed March 30, 2021, which is incorporated by reference in its entirety.

[0002] The present disclosure relates generally to medical fluid connectors, and more particularly to auto-shutoff male luer fittings that are designed to close a fluid path upon disconnection from a medical access device. [Background technology]

[0003] Medical connections are widely used in fluid delivery systems such as those used to connect intravenous fluid lines, blood access, hemodialysis, peritoneal dialysis, enteral nutrition, drug vial access and more.

[0004] Conventional medical connectors require the healthcare provider to exercise extreme caution when connecting or disconnecting due to the possibility of medication remaining inside the connector or dripping out when disconnected, especially when the connector is primed with fluid. The healthcare provider must also ensure that all clamps are physically closed to prevent a free-flow leak condition. Some female connectors are designed to push fluid in the throat of the connector to the surface when disconnected. This is desirable for a sterile connector that provides a wipeable surface, but can result in fluid dripping out of the device when disconnected. Other connectors use a membrane with a septum, but this can also allow fluid to leak out of the connector.

[0005] A statement provided in the Background section should not be considered prior art merely because it is mentioned in or associated with the Background section. The Background section may include information that describes one or more aspects of the subject technology. Summary of the Invention [Problem to be solved by the invention]

[0006] What is needed is a connector for medical fluids that has a standardized connection for use with existing medical connectors and that minimizes or eliminates dripping upon connection or disconnection. Also, what is needed is an auto-shutoff male luer connector that allows the clinician to easily disconnect without having to physically close all the clamps to prevent a free-flow leak condition. [Means for solving the problem]

[0007] According to various embodiments of the present disclosure, a medical connector may include a body having an outer surface and an inner surface defining a lumen of the body, an inlet port defined at a proximal end of the body and an outlet port defined at a distal end of the body, and a compressible valve member. The compressible valve member may have a normally closed slit and be disposed within the lumen and extend outside the medical connector through the inner and outer surfaces of the body. The compressible valve member may be configured to compress radially inwardly to open the slit upon insertion of the body into the medical access device. The compressible valve member may be further configured to expand radially outwardly to close the slit upon separation of the body from the medical access device.

[0008] According to various embodiments of the present disclosure, a method of assembling a medical connector can include providing a connector body having an outer surface and an inner surface defining a lumen of the connector body, The method can further include positioning a compressible valve member having a normally closed slit within the lumen with the outer surface of the compressible valve member extending through the inner and outer surfaces of the connector body to an exterior of the medical connector.

[0009] According to various embodiments of the present disclosure, a connector assembly may include a female luer having an outer surface and an inner surface defining a female luer lumen, and a male luer removably disposed at least partially within the inner lumen of the female luer. The male luer may include a body having an outer surface and an inner surface defining a lumen of the body, and a compressible valve member disposed within the lumen and extending through the inner and outer surfaces of the body. The compressible valve member may have an outer surface and an inner surface including a slit. When the male luer is disposed within the female luer, the inner surface of the female luer may compress at least a portion of the outer surface of the compressible valve member to open the slit. Upon removal from the female luer, the compressible valve member may expand radially outward to close the slit.

[0010] Other configurations of the subject technology will be readily apparent to those skilled in the art from the following detailed description, with the understanding that various configurations of the subject technology are shown and described by way of example. As will be understood, the subject technology is capable of other and different configurations, and its several details are capable of modification in various other respects, all without departing from the scope of the subject technology. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature, and not as restrictive.

[0011] The accompanying figures are included to illustrate certain aspects of the embodiments and should not be considered as exclusive examples. The disclosed subject matter is capable of considerable modification, substitutions, combinations, and equivalents in form and function, as will occur to those skilled in the art and having the benefit of this disclosure. [Brief description of the drawings]

[0012] [Figure 1] 1 illustrates a perspective view of a male luer medical connector for fluid delivery according to some embodiments of the present disclosure. [Figure 2A] 1 illustrates a partial perspective view of a male luer medical connector with a valve member in an open position according to some embodiments of the present disclosure. [Figure 2B] 2B illustrates a front plan view of the male luer medical connector of FIG. 2A according to some embodiments of the present disclosure. [Figure 3A] 1 illustrates a partial perspective view of a male luer medical connector with a valve member in a closed position according to some embodiments of the present disclosure. [Figure 3B] 3B illustrates a front plan view of the male luer medical connector of FIG. 3A according to some embodiments of the present disclosure. [Figure 4A] 1 illustrates a partial cross-sectional view of a male luer medical connector with a valve member in an open position according to some embodiments of the present disclosure. [Figure 4B] 1 illustrates a partial cross-sectional view of a male luer medical connector with a valve member in a closed position according to some embodiments of the present disclosure. [Figure 5A] 1 illustrates a cross-sectional view of a male Luer medical connector having a compressible valve member in connection with a medical access device. [Figure 5B] 1 illustrates a cross-sectional view of a male Luer medical connector in which the compressible valve member is in a disconnected state with the medical access device. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0013] The detailed description set forth below describes various configurations of the subject technology and is not intended to represent the only configurations in which the subject technology may be practiced. The detailed description includes specific details to provide a thorough understanding of the subject technology. Thus, dimensions may be provided for certain embodiments as non-limiting examples. However, it will be apparent to one skilled in the art that the subject technology may be practiced without these specific details. In some cases, well-known structures and components are shown in block diagram form to avoid obscuring concepts of the subject technology.

[0014] It should be understood that the present disclosure includes examples of the subject technology and does not limit the scope of the appended claims. Various aspects of the subject technology are disclosed herein according to specific, but non-limiting examples. Various embodiments described in the present disclosure can be implemented in different ways and variations according to a desired application or implementation.

[0015] Various embodiments of the present disclosure relate to providing a medical connector that minimizes fluid leakage resulting from unexpected or inadvertent separation of the medical connector from a medical access device, such as a female luer or other needleless valve. Similar to existing medical connectors, the male luer portion of the medical connector of various embodiments of the disclosure described herein can be inserted into the female luer of another needleless access device to create a fluid pathway between the fluid delivery mechanism and the patient. To avoid dripping or leakage of medical fluids that may be harmful to a healthcare provider or patient, the medical connector of various embodiments described herein is designed to minimize or eliminate dripping or leakage of fluids upon connection of the medical connector 100 to another access device, or upon separation from another access device, especially when both devices are primed with fluid.

[0016] According to various aspects of the present disclosure, the proximal end of the medical connector may include an inlet port that may be connected to a fluid delivery source or device, such as an IV fluid bag, a pump, or the like. In some embodiments, the medical connector may be a male luer having a male luer portion that is International Organisation for Standardisation (ISO) compliant and has a body that interfaces with a standard female luer or needleless access device. As will be described in further detail, the medical connectors of various embodiments described herein may differ from traditional male luers by including a compressible valve member that includes a normally closed slit. The compressible valve member may be disposed within an internal lumen of the medical connector and extend outside the medical connector through an internal and external surface of the body. In some embodiments, the compressible valve member may be configured to compress radially inwardly to open the slit upon insertion of the body into the medical access device. The compressible valve member may be configured to expand radially outwardly to close the slit upon separation of the body from the medical access device. Thus, the medical connectors of various embodiments described herein may advantageously prevent dripping or leaking of medical fluids, a common problem that occurs upon separation of existing medical connectors (e.g., male luers) from medical access devices. Further advantageously, the auto-shutoff of the medical connectors of various embodiments described herein may allow for easy separation without the clinician having to physically close all the clamps to prevent a free-flow leak condition.

[0017] FIG. 1 illustrates a perspective view of a male luer medical connector 100 for fluid delivery, according to some embodiments of the present disclosure. As shown, the medical connector 100 may include a body 102. The body 102 may have an exterior surface 104 and an interior surface 109 that defines a lumen 111 of the body 102. The connector 100 may further include an inlet port 106 defined at a proximal end 105 of the body 102 and an outlet port 108 defined at a distal end 107 of the body 102. The inlet port 106 may be connected to a fluid delivery source or device, such as an IV fluid bag, a pump, or the like. As will be described in further detail below with respect to at least FIGS. 5A and 5B, the distal end 107 including the outlet port 108 of the medical connector 100 may be inserted into a female luer of another medical access device to create a fluid pathway 126 between the fluid delivery source or device and a patient. In some embodiments, the lumen 111 is in fluid communication with the inlet port 106 and the outlet port 108 and forms part of a fluid pathway between a fluid delivery source or device and a patient.

[0018] In some embodiments, the inlet port 106 can receive a male luer portion of another medical access device to allow fluid to pass to the fluid pathway 126. Thus, the proximal end 105 of the connector 100 can be in the form of a female luer portion, or can be in the form of any other type of inlet port, such as a bond pocket or other connector, while remaining within the concepts described herein.

[0019] FIG 2A shows a partial perspective view of the male luer medical connector 100 with the valve member 116 in an open position according to some embodiments of the present disclosure. FIG 2B shows a front plan view of the male luer medical connector 100 of FIG 2A according to some embodiments of the present disclosure. FIG 3A shows a partial perspective view of the male luer medical connector 100 with the valve member 116 in a closed position according to some embodiments of the present disclosure. FIG 3B shows a front plan view of the male luer medical connector 100 of FIG 3A according to some embodiments of the present disclosure.

[0020] 2A-3B, the connector 100 may further include a compressible valve member 116 disposed within the lumen 111. As shown in FIGS. 2A and 2B, the compressible valve member 116 may extend through the inner surface 109 and the outer surface 104 of the body 102 to the exterior of the medical connector 100. In some embodiments, the compressible valve member 116 may be formed from, or in other cases may include, an elastomeric material. In some embodiments, the elastomeric material may be silicone, Thermoplastic Polyurethane (TPU), or a combination thereof.

[0021] As further shown in Figures 3A and 3B, the compressible valve member 116 may further include a normally closed slit 112 that may be configured to selectively open and close the fluid pathway 126 between the fluid delivery source or device and the patient. In particular, as shown in Figures 2A and 3A, and as will be described in further detail with respect to Figures 5 and 5B, the compressible valve member 116 may be configured to compress radially inwardly to open the slit 112 upon insertion of the body 102 into the medical access device 150. Additionally, as shown in Figures 2B and 3B, and as will be described in further detail with respect to Figures 5A and 5B, the compressible valve member 116 may be configured to expand radially outwardly to close the slit 112 upon separation of the body 102 from the medical access device 150.

[0022] FIG 4A illustrates a partial cross-sectional view of a male luer medical connector with a valve member in an open position, according to some embodiments of the present disclosure. FIG 4B illustrates a partial cross-sectional view of a male luer medical connector with a valve member in a closed position, according to some embodiments of the present disclosure. With continued reference to FIGS 2A-3B and with reference to FIGS 4A and 4B, an outer surface 110 of the compressible valve member 116 may extend outside the medical connector 100. The compressible valve member 116 may further include an inner surface having a slit 112 defined therein. As shown, the slit 112 may define at least a portion of a flow path through the compressible valve member.

[0023] FIG. 5A illustrates a cross-sectional view of a male luer medical connector with a compressible valve member in a connected state with a medical access device. FIG. 5B illustrates a cross-sectional view of a male luer medical connector with a compressible valve member in a disconnected state with a medical access device. According to various embodiments of the present disclosure, the compressible valve member 116 can have a proximal end 113 and a distal end 115. As shown in FIGS. 5A and 5B, the body of the compressible valve member can have a tapered shape from the distal end to the proximal end. For example, in some embodiments, the compressible valve member can be a duckbill valve.

[0024] 5A and 5B, with continued reference to FIGS. 3A-4B, the slit 112 may divide at least a portion of the body 118 of the compressible valve member 116 into a first valve section 118A and a second valve section 118B. In operation, as shown in FIG. 5A, when the body 102 of the medical connector 100 is inserted into the medical access device 150, the first valve section 118A and the second valve section 118B are biased away from each other to open the slit 112. When the slit 112 is opened, the fluid pathway 126 between the fluid delivery source or device and the patient is opened, thereby placing the lumen of the medical access device 150 and the lumen 111 of the medical connector 100 in fluid communication.

[0025] In particular, the outer surface 110 of the compressible valve member 116 extends outside the medical connector 100 and may protrude above the outer surface of the body 102 such that, upon engagement of the medical connector 100 with the medical access device 150, contact between the outer surface 110 of the valve member 116 and the inner surface 127 of the medical access device 150 exerts a force that compresses the compressible valve member 116 radially inwardly to fit within the lumen of the medical access device 150. As the valve member 116 is compressed, the first valve section 118A and the second valve section 118B are biased away from one another to open the slit 112, as shown in Figures 3A and 4A.

[0026] As the body 102 of the medical connector 100 continues to be inserted into the medical access device 150, the first valve section 118A and the second valve section 118B continue to be biased away from each other until the slit is in a fully open position and the formation of the fluid pathway 126 through the connector 100 and the medical access device 150 is complete. In the illustrated embodiment, the connector 100 and the medical access device 150 are shown as being securely attached by an interference or press fit, although various embodiments of the present disclosure are not limited to such configuration. In some embodiments, the connector 100 and the medical access device 150 may be securely attached using complementary threads on the connector 100 and the medical access device.

[0027] Upon separation, as shown in FIG. 5B, removal of the connector 100 from the medical access device 150 removes the compressive force applied to the outer surface 110 of the compressible valve member 116, thereby allowing the compressible valve 116 to expand radially outward to its original, uncompressed state. In particular, when the body 102 of the medical connector 100 is removed or separated from the medical access device 150 (as shown in FIG. 5B), the first valve section 118A and the second valve section 118B are biased toward each other (as shown in FIGS. 3B and 4B) to close the slit 112. With the slit 112 in the fully closed position, the fluid pathway 126 through the connector 100 and the medical access device 150 is closed, thereby preventing fluid communication between the connector 100 and the medical access device 150.

[0028] Although medical access device 150 is shown in the form of a female luer with a valve plug configuration, connector 100 will work with any standard female luer medical access device including a bellows type plug, a device with a septum, or other configuration designed to accept a standardized male luer connector, such as body 102 of medical connector 100.

[0029] According to various embodiments of the present disclosure, a method of assembling a connector 100 may include providing a connector body 102 having an outer surface 104 and an inner surface 109 that defines a lumen 111 of the connector body 102. The method may further include positioning a compressible valve member 116 having a normally closed slit 112 within the lumen 111 with an outer surface of the compressible valve member 116 extending through the inner surface 109 and the outer surface 104 of the connector body 102 to the exterior of the medical connector 100. In some embodiments, providing the connector body 102 further includes forming an inlet port 106 at a proximal end of the body and an outlet port 108 at a distal end of the body, and extending the lumen from the inlet port 106 to the outlet port 108 to define a fluid pathway between the inlet port and the outlet port.

[0030] In some embodiments, the exterior geometry of the connector body may be configured to comply with International Organization for Standardization (ISO) standards.

[0031] The medical connector 100 of various embodiments described herein may differ from conventional male luer connectors by including a compressible valve member including a normally closed slit and a body having an outer surface that extends through the inner and outer surfaces of the medical connector body to the outside of the medical connector. The compressible valve member may advantageously be configured to (i) compress radially inwardly to open the slit upon insertion of the body into the medical access device, and (ii) expand radially outwardly to close the slit upon separation of the body from the medical access device. Thus, the medical connector of various embodiments described herein may advantageously close the fluid path upon separation from the medical access device to prevent dripping or leaking of medical fluids, a common problem that occurs upon separation of existing medical connectors (e.g., male luer) from the medical access device. Further advantageously, the auto-shutoff of the medical connector of various embodiments described herein may allow for easy separation without the need for the clinician to physically close all the clamps to prevent a free-flow leak condition.

[0032] The present disclosure is provided to enable any person skilled in the art to practice the various configurations described herein. The present disclosure provides various examples of the subject technology, and 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.

[0033] The subject technology is exemplified according to various aspects, for example, as described below. Various examples of aspects of the subject technology are described as numbered clauses (1, 2, 3, etc.) for convenience. These are presented as examples and not as limitations of the subject technology. Note that any of the dependent clauses may be combined in any combination and may be placed into a respective independent clause, e.g., clause 1 or clause 5. Other clauses may be presented in a similar manner.

[0034] Clause 1. A medical connector comprising: a body having an outer surface and an inner surface defining a body lumen; an inlet port defined at a proximal end of the body and an outlet port defined at a distal end of the body; and a compressible valve member having a normally closed slit disposed within the lumen and extending through the inner and outer surfaces of the body to an exterior of the medical connector, the compressible valve member configured to compress radially inwardly to open the slit upon insertion of the body into a medical access device, and the compressible valve member configured to expand radially outwardly to close the slit upon separation of the body from the medical access device.

[0035] Clause 2. The medical connector described in clause 1, wherein the compressible valve member has a body having an outer surface extending outside the medical connector, and the slit has an inner surface defining a flow path through the body of the compressible valve member.

[0036] Clause 3. The medical connector described in clause 2, wherein the body of the compressible valve member has a proximal end and a distal end, and the body of the compressible valve member has a tapered shape from the distal end to the proximal end.

[0037] Clause 4. The medical connector of clause 2, wherein the slit divides at least a portion of the body of the compressible valve member into a first valve section and a second valve section, and when the body of the medical connector is inserted into the medical access device, the first valve section and the second valve section are biased away from each other to open the slit.

[0038] Clause 5. The medical connector of clause 4, wherein the outer surface of the body of the compressible valve member is compressed radially inward by an inner surface of the medical access device to urge the first valve section and the second valve section away from each other and open the slit.

[0039] Clause 6. The medical connector of clause 4, wherein when the body of the medical connector is removed or separated from the medical access device, the first valve section and the second valve section are biased toward each other to close the slit.

[0040] Clause 7. The medical connector of clause 6, wherein the outer surface of the body of the compressible valve member expands radially outward when the body of the medical connector is detached or separated from the inner surface of the medical access device to urge the first valve section and the second valve section toward each other and close the slit.

[0041] Clause 8. The medical connector of any one of clauses 1 to 7, wherein the compressible valve member comprises an elastomeric material.

[0042] Clause 9. The medical connector of clause 8, wherein the elastomeric material comprises silicone, thermoplastic polyurethane (TPU), or a combination thereof.

[0043] Clause 10. A medical connector described in any one of clauses 1 to 9, wherein the compressible valve member has a duckbill valve.

[0044] Clause 11. A method of assembling a medical connector, comprising the steps of providing a connector body having an outer surface and an inner surface defining a lumen of the connector body, and positioning a compressible valve member having a normally closed slit within the lumen with an outer surface of the compressible valve member extending through the inner surface and the outer surface of the connector body to an exterior of the medical connector.

[0045] Clause 12. The method of clause 11, wherein preparing the connector body further comprises forming an inlet port at a proximal end of the connector body and an outlet port at a distal end of the connector body, and extending the lumen from the inlet port to the outlet port to define a fluid pathway between the inlet port and the outlet port.

[0046] Clause 13. The method of clause 11 or 12, wherein preparing the connector body further comprises forming the geometry of the outer surface of the connector body to comply with an International Organization for Standardization (ISO) standard.

[0047] Clause 14. The method of any one of clauses 11 to 13, wherein positioning the compressible valve member comprises positioning a compressible valve member formed from an elastomeric material within the lumen.

[0048] Clause 15. The method of clause 14, wherein positioning the compressible valve member comprises positioning a compressible valve member formed from silicone, thermoplastic polyurethane (TPU), or a combination thereof within the lumen.

[0049] Clause 16. A connector assembly having a female luer having an outer surface and an inner surface defining a female luer lumen, and a male luer removably positioned at least partially within the lumen of the female luer, wherein the male luer has a body having an outer surface and an inner surface defining a lumen of the body, and a compressible valve member positioned within the lumen and extending through the inner surface and the outer surface of the body, the compressible valve member having an outer surface and an inner surface having a slit, wherein when the male luer is positioned within the female luer, the inner surface of the female luer compresses at least a portion of the outer surface of the compressible valve member to open the slit, and upon removal from the female luer, the compressible valve member expands radially outward to close the slit.

[0050] Clause 17. A connector assembly as described in clause 16, wherein the slit divides at least a portion of the compressible valve into a first valve section and a second valve section, and when the body of the male luer is inserted into the female luer, the first valve section and the second valve section are biased away from each other to open the slit.

[0051] Clause 18. A connector assembly as described in clause 17, wherein when the body of the male luer is removed or separated from the female luer, the first valve section and the second valve section are biased towards each other to close the slit.

[0052] Clause 19. A connector assembly as described in any one of clauses 16 to 18, wherein the compressible valve member comprises an elastomeric material.

[0053] Clause 20. The connector assembly of clause 19, wherein the elastomeric material comprises silicone, thermoplastic polyurethane (TPU), or a combination thereof.

[0054] Reference to a singular element is intended to mean "one or more" and not "one and only one" unless specifically stated so. The term "several" refers to one or more, unless specifically stated otherwise. Masculine pronouns (e.g., his) include feminine and neuter (e.g., her and its) and vice versa. Headings and subheadings, if any, are used merely for convenience and do not limit the invention.

[0055] 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.

[0056] As used herein, the phrase "at least one of" following a series of items, when followed by the word "or" separating any of those items, modifies the list as a whole and not each item in the list. The phrase "at least one of" does not require the selection of at least one item; rather, the phrase allows for a meaning including at least one of any one of the items, and / or at least one of any combination of the items, and / or at least one of each of the items. Illustratively, the phrase "at least one of A, B, or C" can refer to only A, only B, or only C, or any combination of A, B, and C.

[0057] The use of a phrase such as "aspect" does not imply that such aspect is essential to the subject technology, nor that such aspect applies to all configurations of the subject technology. A 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 an 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, nor that such embodiment applies to all configurations of the subject technology. A disclosure of an embodiment may apply to all configurations, or to one or more examples. An embodiment may provide one or more examples. A phrase such as an embodiment may refer to one or more examples, and vice versa. A phrase such as "configuration" does not imply that such embodiment is essential to the subject technology, nor that such embodiment applies to all configurations of the subject technology. A disclosure of a configuration may apply to all configurations, or to one or more configurations. A configuration may provide one or more instances. A phrase such as a configuration may refer to one or more configurations, and vice versa.

[0058] In one aspect, unless otherwise stated, all measurements, values, ratings, locations, sizes, dimensions, and other specifications set forth herein, including those in the claims which follow, are approximate and not precise, and in one aspect, they are intended to have a reasonable range consistent with the function to which they relate and the customary practice in the art to which they pertain.

[0059] It is understood that the specific order or hierarchy of steps or operations in the disclosed processes or methods is an illustration of example approaches. It is understood that based on implementation priorities or scenarios, the specific order or hierarchy of steps, operations or processes may be rearranged. Some of the steps, operations or processes may be performed simultaneously. In some implementation priorities or scenarios, certain operations may or may not be performed. Some or all of the steps, operations or processes may be performed automatically, without user intervention. The accompanying method claims present elements of the various steps, operations or processes in a sample order, and are not meant to be limited to the specific order or hierarchy presented.

[0060] All structural and functional equivalents to the elements of the various embodiments described throughout this disclosure that are known or that later become known to those skilled in the art are intended to be expressly incorporated herein by reference and encompassed by the claims. Moreover, nothing disclosed herein is intended to be made available to the public, regardless of whether such disclosure is expressly set forth in the claims. No element of a claim is to be construed under the provisions of 35 U.S.C. 112(f) 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". Moreover, to the extent that terms such as "include", "have", and the like are used, such terms are intended to be inclusive in the same manner as the term "comprise" would be construed if "comprise" were used as a transitional phrase in a claim.

[0061] The title, background, summary, brief description of the drawings, and abstract of the present disclosure are hereby incorporated by reference into the present disclosure and are provided as illustrative examples of the present disclosure, and not as a limiting description of the present disclosure. The present disclosure is submitted with the understanding that they will not be used to limit the scope or meaning of the claims. Furthermore, in the detailed description, it will be appreciated that the description provides illustrative examples, and that various features have been grouped together in various embodiments for the purpose of streaming the disclosure. The method of the present disclosure should not be interpreted as indicating an intention that the claimed subject matter requires more features than are expressly recited in each claim. Rather, as the appended claims reflect, inventive subject matter lies in less than all features of a single disclosed structure or operation. The appended claims are hereby incorporated by reference into the detailed description, with each claim standing on its own as separately claimed subject matter.

[0062] The claims are not intended to be limited to the embodiments described herein, but are to be accorded full scope consistent with the language of the claims and encompass all legal equivalents. However, none of the claims are intended, and should not be construed, to encompass subject matter that does not comply with the requirements of 35 U.S.C. §§ 101, 102, or 103.

Claims

1. A medical connector (100), a body (102) having an outer surface (104), an inner surface, an inlet port (106) defined at a proximal end (105) of the body, and an outlet port (108) defined at a distal end (107) of the body, the inner surface (109) defining a lumen (111) of the body between the inlet port and the outlet port; a compressible valve member (116) disposed within the lumen (111) of the body, the compressible valve member (116) having a normally closed slit (112) and an outer surface (110), the outer surface (110) including a portion that extends from the lumen (111) onto the outer surface (104) of the body; having a medical connector, the portion of the compressible valve member extending over the outer surface being configured to compress radially inward to open the slit (112) upon insertion of the body into a medical access device, and the portion of the compressible valve member being configured to expand radially outward to close the slit (112) upon separation of the body (102) from the medical access device.

2. The medical connector of claim 1 , wherein the compressible valve member has a body (118) and the slit (112) has an inner surface that defines a flow path through the body (118) of the compressible valve member.

3. 3. The medical connector of claim 2, wherein the compressible valve member body (118) has a proximal end (113) and a distal end (115), the compressible valve member body (118) having a tapered shape from the distal end (115) to the proximal end (113).

4. 3. The medical connector of claim 2, wherein the slit (112) divides at least a portion of the body (118) of the compressible valve member into a first valve section (118A) and a second valve section (118B), and when the body (102) of the medical connector is inserted into the medical access device, the first valve section and the second valve section are biased away from each other to open the slit (112).

5. 5. The medical connector of claim 4, wherein the outer surface of the compressible valve member body (118) is compressed radially inward by an inner surface of the medical access device, thereby urging the first valve section (118A) and the second valve section (118B) away from one another to open the slit (112).

6. 5. The medical connector of claim 4, wherein when the body (102) of the medical connector is removed or separated from the medical access device, the first valve section (118A) and the second valve section (118B) are biased toward each other to close the slit (112).

7. 7. The medical connector of claim 6, wherein the outer surface of the compressible valve member body (118) expands radially outward when the medical connector body (102) is removed or separated from an inner surface of the medical access device, thereby urging the first valve section (118A) and the second valve section (118B) toward each other to close the slit (112).

8. The medical connector of claim 1 , wherein the compressible valve member (116) comprises an elastomeric material.

9. The medical connector of claim 1 , wherein the compressible valve member (116) comprises a duckbill valve.

10. The medical connector of claim 1, wherein the body (102) has an opening extending from the inner surface to the outer surface of the body, and the portion of the compressible valve member (116) extends through the opening.

11. 1. A method of assembling a medical connector, comprising: providing a connector body (102) having an outer surface (104) and an inner surface (109), said inner surface (109) defining a lumen (111) of said connector body; positioning within the bore (111) a compressible valve member (116) having a normally closed slit (112) and an outer surface (110), a portion of the outer surface of the compressible valve member extending from the bore (111) onto the outer surface (104) of the connector body; A method comprising:

12. 12. The method of claim 11, wherein the step of providing the connector body (102) further comprises forming an inlet port (106) at a proximal end (105) of the connector body and an outlet port (108) at a distal end (107) of the connector body, and extending the lumen (111) from the inlet port to the outlet port to define a fluid pathway between the inlet port (106) and the outlet port (108).

13. 12. The method of claim 11, wherein providing the connector body (102) further comprises forming a geometry of the outer surface (104) of the connector body to comply with an International Organization for Standardization (ISO) standard.

14. The method of claim 11 , wherein the step of positioning a compressible valve member comprises positioning a compressible valve member (116) formed from an elastomeric material within the lumen (111).

15. 15. The method of claim 14, wherein the step of positioning the compressible valve member (116) comprises positioning a compressible valve member formed from silicone, thermoplastic polyurethane (TPU), or a combination thereof within the lumen.

16. a female luer (150) having an outer surface (120) and an inner surface (124), the inner surface defining a lumen (122, 126) of the female luer; a male luer (100, 150) removably disposed at least partially within the lumen of the female luer; 1. A connector assembly having: The male lure is a body (102) having an outer surface (104), an inner surface (109), an inlet port (106) defined at a proximal end (105) of the body, and an outlet port (108) defined at a distal end (107) of the body, the inner surface (109) defining a lumen (111) of the body between the inlet port and the outlet port; a compressible valve member (116) disposed within the bore (111), the compressible valve member having a normally closed slit and an outer surface (110), the outer surface including a portion that extends from the bore (111) onto the outer surface (104) of the body; having when the male luer is disposed within the female luer, the inner surface (124) of the female luer compresses at least the portion of the compressible valve member that extends over the outer surface to open the slit (112); and When removed from the female luer, the compressible valve member (116) expands radially outwardly to close the slit (112).

17. 17. The connector assembly of claim 16, wherein the slit (112) divides at least a portion of the compressible valve member into a first valve section (118A) and a second valve section (118B), and when the body (102) of the male luer is inserted into the female luer (150), the first valve section and the second valve section are biased away from each other to open the slit (112).

18. 18. The connector assembly of claim 17, wherein when the male luer body (102) is removed or separated from the female luer (150), the first valve section (118A) and the second valve section (118B) are biased toward each other to close the slit (112).

19. The connector assembly of claim 16, wherein the compressible valve member (116) comprises an elastomeric material.

20. A connector assembly as described in claim 16, wherein the body (102) has an opening extending from the inner surface to the outer surface of the body, and the portion of the compressible valve member (116) extends through the opening.

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