Medical fluid connector

Abstract

The invention relates to a medical fluid connector, in particular to a needle-free fluid connector provided with a multi-gear fluid control valve, and provides neutral pressure experience for a user. A fluid connector includes two coaxially interconnected end pieces constituting both ends of the connector and a fluid channel extending through each end piece within each end piece, the channels together providing fluid communication between opposite ends; a multi-stage fluid control valve is disposed within the interconnected end pieces that closes a fluid passage through which fluid flows through the two end pieces through the connector when the fluid control valve is inactive, the control valve including a resiliently compressible assembly that can be activated such that the resilient assembly places the control valve in a partial flow condition, wherein fluid flows into the fluid passage of the first end piece, but maintains fluid from the outlet through the fluid passage of the opposite second end piece, and such that the resilient assembly places the control valve in a fully open state, allowing fluid to flow through the fluid passages of the first and second end pieces through the connector.

Description

Technical Field

[0001] The present invention relates to the field of medical devices, and in particular to a fluid connector suitable for the medical field. Background Art

[0002] Needleless connectors, used to connect intravenous (IV) catheters, drug delivery sets, and syringes, are beginning to be used by healthcare providers to reduce the risk of needlestick injuries. They are devices that allow for quick access to infusion lines without the use of a needle. Generally, there are two main categories of needleless connectors, namely (1) simple connectors with no internal moving parts, such as connectors with external split septa; and (2) complex connectors that rely on internal moving parts, such as mechanical valves, to control the flow of fluid within the device. The internal structure of the connector determines how the device manages fluid displacement and fluid pathways. The American Journal of Nursing (AJN), Vol. 112, No. 11 is cited to illustrate the relationship between fluid displacement and fluid pathways, and its implications as they relate to needleless connectors.

[0003] Patent Cooperation Treaty Patent Publication No. 9850106A1 discloses an exemplary needle-free fluid connector. Specifically, the connector includes a movable diaphragm assembly and an internal central cannula. More specifically, the diaphragm is and includes a cam formed therein, wherein the cam engages with a proximal portion of the internal cannula to facilitate movement of the diaphragm through the proximal portion of the internal cannula. Another example is disclosed by U.S. Patent No. 9855412B2, specifically a needle-free valve for interconnecting with a straight-mouth fluid supply nozzle, wherein the valve includes a base with a connector; a solid elongated fluid flow path stem; and a hollow flexible plug providing a variable volume fluid flow path between an inlet end and an outlet end thereof, such that when the plug is restored to its deactivated configuration, the variable fluid flow path enables residual fluid therein to be discharged from the valve. Summary of the Invention

[0004] One aspect of the present invention is a needleless connector suitable for use with, but not limited to, intravenous (IV) catheters, drug delivery devices, and syringes. The connector facilitates the administration of liquid substances into a patient's body or the removal of bodily fluids from a patient. For example, one side of the connector is configured to connect to a medical device or tool, such as, but not limited to, a needleless syringe, an IV drip, or a blood transfusion tube, while the other side of the connector is configured to connect to an adapter on the patient, such as a catheter or a Luer lock extension set.

[0005] One aspect of the present invention is a bidirectional fluid connector equipped with a valve that can be repeatedly opened and closed. More specifically, the connector comprises a housing and a multi-position fluid control valve comprising an elastically compressible component. The housing and the elastically compressible component cooperate to provide a pressure exceeding a predetermined value to maintain the connector in an open or closed position.

[0006] Another aspect of the present invention is a neutral-pressure fluid connector. More specifically, the connector is configured to provide neutral fluid displacement, thereby preventing blood from entering the catheter lumen during connection or disconnection. To this end, the connector is equipped with a multi-position fluid control valve to manage pressure fluctuations within the connector. Advantageously, the patient can experience fluid inflow or outflow at the lowest position.

[0007] Another aspect of the present invention is to provide a wipeable medical connector. More specifically, the connector can be wiped with a suitable disinfectant in a conventional manner before use.

[0008] Another aspect of the present invention is to provide a backflow-proof fluid connector. More specifically, the connector is configured with a multi-position fluid control valve so that backflow, such as that caused by syringe rebound or disconnection, can be captured therein.

[0009] Another aspect of the present invention is to provide a fluid connector configured with a transparent material so that the fluid transferred therein can be seen with the naked eye. More specifically, the transparent material used can be polycarbonate.

[0010] The present invention satisfies at least one of the above aspects in whole or in part, wherein one embodiment of the present invention is a fluid connector (100), in particular an interconnector for use in a fluid pathway for medical purposes, the fluid connector comprising, when assembled, two coaxial, interconnected end pieces (201, 202), which form two opposite ends of the connector, and a fluid channel extending through each end piece in each end piece, the two fluid channels together providing fluid communication between the two opposite ends, a multi-position fluid control valve (300) provided in the interconnected end pieces (201, 202), which closes the fluid channel flowing through the connector (100) through the two end pieces (201, 202) when the fluid control valve is in a non-conducting state, the control valve (300) The invention comprises an elastic compressible component (301, 302), which can be activated to cause a first predetermined compression of the elastic component to cause the control valve to enter a partial flow state, wherein the fluid flows into the fluid passage of the first end piece (201), but maintains the fluid from the outlet to flow through the fluid passage of the opposite second end piece (202), and causes continued further second predetermined compression of the elastic component to cause the control valve to be in a fully open state, allowing the fluid to flow through the fluid passage of the first end piece (201) and the second end piece (202) through the connector (100), wherein the disconnection of the connector (100) from the fluid passage is affected by the multi-stage relaxation of the elastic component (301, 302) to a fully relaxed state to prevent the fluid from flowing through the connector.

[0011] Preferably, the first end piece (201) is at least partially received within the second end piece (202), and wherein the first end piece (201) houses the resiliently compressible assembly (301, 302).

[0012] Preferably, the elastically compressible component includes a first component (301) and a second component (302), the former mainly controlling the flow of fluid in the fluid channel of the first end piece (201), and the latter mainly controlling the flow of fluid through the second end piece (202).

[0013] Preferably, the first component (301) is elastically movable within the first end piece (201) to open and close the fluid flowing therethrough, wherein the second component (302) is also elastically movable within the first end piece (201) to open and close the fluid flowing through the second end piece (202).

[0014] Preferably, a portion of the fluid passage of the second end piece (202) extends within the fluid passage of the first end piece (201), thereby providing a portion of the fluid passage to the fluid passage of the first end piece (201).

[0015] Preferably, the second component (302) controls the flow of fluid through the first end piece (201) and the second end piece (202) by opening and closing fluid communication via a channel portion extending within the first end piece.

[0016] Preferably, the coaxial conduit element (400) is disposed within the first end piece (201) and arranged between the first component (301) and the second component (302) of the elastic component, wherein the flow of fluid through one end of the conduit element (400) is controlled by the first component (301) and the flow of fluid through the other end of the conduit element (400) is controlled by the second component (302).

[0017] Preferably, the arrangement is such that a first predetermined pressure causes compression of the first component (301) to open fluid communication of the first end piece (201) through the conduit element (400), wherein a second predetermined pressure causes axial movement of the conduit element (400) and compression of the second component (302) to encourage fluid flow through the two end pieces (201, 202) of the connector (100).

[0018] Preferably, the second predetermined pressure causes fluid communication between the other end of the conduit element (400) and the fluid passageway of the second end piece (302) of the connector. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] Figure 1 A perspective illustration depicting an embodiment of an assembled connector (100) of the present disclosure is shown.

[0020] Figure 2 Shown Figure 1 perspective section view of .

[0021] Figure 3 A side view of the assembled connector (100) in a fully relaxed (closed) position is shown in accordance with an embodiment of the present disclosure.

[0022] Figure 4 A side view of an assembled connector (100) in a partially open position is shown in accordance with an embodiment of the present disclosure.

[0023] Figure 5 A side view showing an assembled connector (100) in a fully open position according to an embodiment of the present disclosure

[0024] Figure 6 A perspective illustration depicting an exemplary first end piece (201) of a connector (100) of the present disclosure is shown.

[0025] Figure 7 Shown Figure 6 Cross-sectional perspective view.

[0026] Figure 8A side view of an exemplary first end piece (201) of a connector (100) of the present disclosure is shown.

[0027] Figure 9 is a perspective illustration of an exemplary first component (301) of the elastically compressible component of the present disclosure, with dashed lines depicting its internal structure.

[0028] Figure 10 Shown Figure 9 sectional view.

[0029] Figure 11 A side view of an exemplary first assembly (301) of a resiliently compressible assembly of the present disclosure is shown.

[0030] Figure 12 A perspective illustration of an exemplary coaxial catheter element (400) depicting a connector (100) of the present disclosure is shown.

[0031] Figure 13 Shown Figure 12 sectional view.

[0032] Figure 14 A side view of an exemplary coaxial catheter element (400) of the connector (100) of the present disclosure is shown.

[0033] Figure 15 Shown is a side view of a coaxial catheter element (400) installed in a first assembly (301) of the resiliently compressible assemblies of the present disclosure.

[0034] Figure 16 is a perspective illustration depicting an exemplary second assembly (302) of an elastically compressible assembly according to the present disclosure.

[0035] Figure 17 Shown Figure 16 sectional view.

[0036] Figure 18 A side view of an exemplary second assembly (302) of a resiliently compressible assembly according to the present disclosure is shown.

[0037] Figure 19 A perspective illustration of an exemplary second end piece (202) of a connector according to the present disclosure is shown.

[0038] Figure 20 yes Figure 19 Cross-sectional perspective view.

[0039] Figure 21 A side view of an exemplary second end piece (202) of a connector (100) of the present disclosure is shown. DETAILED DESCRIPTION

[0040] Exemplary, non-limiting embodiments of the present invention will be disclosed. However, it should be understood that limiting the description to the preferred embodiments of the present invention is merely to facilitate discussion of the present invention, and it is contemplated that those skilled in the art may design various modifications without departing from the scope of the appended claims.

[0041] according to Figure 1 , the connector (100) includes a housing (200) having two opposite ends. One end of the connector is referred to herein as the proximal end, and the other end is referred to herein as the distal end. In use, the proximal end can be connected to a suitable external medical device or system, such as but not limited to a blood transfusion device, a drug delivery device, a syringe, and the distal end of the connector can be connected to an adapter on the patient, such as but not limited to a catheter, a Luer lock extension kit. In one embodiment, the proximal end of the housing (200) is formed by a first end piece (201), and the distal end of the housing (200) is formed by a second end piece (202). The first end piece (201) and the second end piece (202) have surface structures that are configured to complement each other to achieve a tight fit or interlocking connection. In particular, the first end piece (201) is at least partially housed within the second end piece (202). In one embodiment, the first end piece (201) is partially mounted in the second end piece (202). Furthermore, the first end piece (201) and the second end piece (202) are configured to selectively form a fluid channel providing fluid communication between the proximal end and the distal end. In one embodiment, the first end piece (201) and the second end piece (202) are coaxial with each other, wherein each end piece has a separate inlet and outlet configured to be aligned along a common central axis (X).

[0042] according to Figure 2 ,6 to 8, the first end piece (201) has a first tubular body (203) and an extended neck (204). More specifically, the outer surface of the neck (204) is configured as a threaded shape, such as the thread shape in a Luer lock or a slider, for connecting to an external device or system. An inlet opening (205) is provided near one end of the neck body, and an outlet opening (206) is provided at the other end, i.e., the opposite end. The inlet opening (205) forms the proximal end of the connector, and the inlet opening (205) is configured to accommodate the multi-stage valve (300) and provide a path for external devices to access the valve. The diameter of the outlet opening (206) is much larger than that of the inlet opening (205), so it allows other components of the connector to enter and be arranged therein through the outlet opening (206). The first tubular body (203) has a substantially smooth outer surface, while the extended neck (204) has an external flange (207) and a convex surface, such as a thread, a raised rib, etc.

[0043] according to Figure 2,19 to 21, the second end piece (202) has a second tubular body (208) corresponding to the first tubular body (203), which is slightly larger in shape and diameter to allow the first tubular body (203) to be installed therein. The second tubular body (208) has an open end (209) and a base (210) opposite thereto, and the base (210) is provided with an internal sleeve (211). In one embodiment, the internal sleeve (211) extends through the base (210) and is configured with a Luer end (212). The size and shape of the second tubular body (208) of the second end piece (202) match the size and shape of the first tubular body (203) of the first end piece (201), so that the first end piece (201) and the second end piece (202) can be connected to each other by a sliding fit or interlocking feature. In one embodiment, the first end piece (201) is slidably connected to the second end piece (202) and stops when it reaches the flange (207). In one embodiment, a seal can be provided between the first end piece (201) and the second end piece (202) to strengthen the connection. As previously described, the base (210) will serve as the base of the housing (200) during assembly. In addition, the Luer end (212) refers to the distal end of the connector (100) that can be connected to an adapter on the patient. The second tubular body (208), the base (210) configured with the inner sleeve (211), and the Luer end (212) are preferably integrally formed. Preferably, they are made of a relatively rigid material compared to the compressible valve (300). In other embodiments, the second end piece (202) can be assembled from the above components, wherein the inner sleeve (211) and the Luer end (212) are made of a relatively rigid material compared to the compressible valve (300). Examples of relatively rigid materials are polycarbonate or acrylonitrile butadiene styrene (ABS).

[0044] according to Figure 1 and Figure 19 The second end piece (202) is provided with an outer surface having gripping features (213). The gripping features may be protrusions or depressions arranged circumferentially around the outer surface of the second tubular body (208). It should be understood that the pattern and arrangement of the gripping features (213) may vary to provide a good grip during use.

[0045] In one embodiment, the inner sleeve (211) extends through the center of the base (210), wherein the inner sleeve (211) provides an inner passage for fluid flow when turned on. Figure 20 and Figure 21One side of the inner sleeve (211) has an opening facing the proximal end of the housing, while the other side of the sleeve (211) is configured with a Luer end (212). In addition, the base (210) can be further configured with a Luer lock (214) to facilitate secure connection at the distal end of the connector (100). The Luer lock (214) herein can be formed by an extension portion extending longitudinally from the second tubular body (208), wherein the portion has a threaded inner wall surrounding the Luer end (212) of the inner sleeve (211).

[0046] In one embodiment, the present invention includes a multi-speed fluid control valve disposed in a first end piece and a second end piece (201, 202). The multi-speed fluid control valve (300) is composed of elastically compressible components, hereinafter referred to as the first component (301) and the second component (302). The elastically compressible components are made of silicone rubber. Preferably, the elastically compressible components include a first component (301) and a second component (302), the former mainly controlling the flow of fluid in the fluid channel of the first end piece (201) and the latter mainly controlling the flow of fluid through the second end piece (202). Their configuration and arrangement can cooperate with each other and work in conjunction with other parts of the connector to provide a fully relaxed (or closed) state when assembled (such as Figure 3 As shown), partially flowing state (as shown Figure 4 as shown) or fully open (as shown Figure 5 shown).

[0047] according to Figures 9 to 11 , the first component (301) has a first hollow bellows that facilitates compression and relaxation wherever the connector is desired to be used. One end of the bellows has a flat surface (303) with an orifice or slit (304) that can expand and open to allow fluid to flow through when compressed and return to a closed position when relaxed. The other end of the bellows has an opening (305) that exposes the hollow inner side of the bellows. Preferably, the first component (301) has a size and outer surface that corresponds to the inner surface of the first end piece (201) and is slidable. More specifically, the first component (301) can be inserted into the first end piece (201) near the extended neck portion (204). After insertion, the end with the flat surface also serves as the proximal end of the connector, which is accessible and can be connected to an external device. In one embodiment, an extension of the open end (305) forms a first engaging member (306), wherein the first engaging member (306) has a larger diameter than the end having the flat surface (303), thereby substantially engaging with the first component (301) within the housing, particularly within the first end piece (201) at the neck (204).

[0048] according to Figures 16 to 18The second component (302) is a second hollow bellows that also assists in compression and relaxation wherever the connector is desired to be used. Figures 2 to 5 , the second component (302) is arranged below the first component (301), near the distal end of the connector. One end (307) of the bellows is closed, while the other end (308) is open, exposing the hollow inner side of the bellows. Preferably, the open end (308) of the bellows has a larger diameter than the closed end (307). In addition, the open end (308) is provided with a second engaging member (309) extending circumferentially, wherein when assembled, the second engaging member (309) can serve as a seal between the first end member (201) and the second end member (202) at the bottom (210). In one embodiment, the closed end (307) is provided with an orifice or slit (310) that can expand and open when compressed to allow fluid to flow therethrough, and return to a closed position when relaxed. In one embodiment, the closed end (307) of the body is configured to be recessed (311) to receive a coaxial catheter element (400), which will be described later. In one embodiment, the second component (302) is configured to shield the inner sleeve (211) of the second end piece (202) when assembled, such as Figure 2 When compressed, the aperture or slit (310) can open and allow fluid to flow therethrough, thereby entering or exiting the inner sleeve (211). In one embodiment, the second component (302) is configured to provide a closed space when in a relaxed position within the housing, thereby trapping backflow from the distal end of the connector to the proximal end of the connector.

[0049] According to the above description, the fluid control valve, when inactive, closes the fluid passage through the two end pieces (201, 202) of the connector (100), and the control valve includes an elastic compressible component that can be activated so that a first predetermined compression of the elastic component causes the control valve to enter a partial flow state ( Figure 4 ), wherein the fluid flows into the fluid passage of the first end piece (201), but the fluid is kept flowing from the outlet through the fluid passage of the opposite second end piece (202), and the continuous further second predetermined compression of the elastic component causes the control valve to enter the fully open state ( Figure 5 ), allowing fluid to flow through the fluid passage of the first end piece (201) and the second end piece (202) through the connector (100), wherein the disconnection of the connector (100) from the fluid passage is caused by the multiple gears of the elastic component being relaxed to a fully relaxed state ( Figure 3 ) to prevent the fluid from flowing through the connector (100).

[0050] In one embodiment, a coaxial conduit element (400) is disposed within a first end piece (201) and between a first component (301) and a second component (302) of an elastic assembly, wherein fluid flow through one end of the conduit element is controlled by the first component (301) and fluid flow through the other end of the conduit element is controlled by the second component (302). A fluid connector having the above arrangement is configured such that a first predetermined pressure causes compression of the first component to open fluid communication through the first end piece (201) through the conduit element (400), wherein a second predetermined pressure causes axial movement of the conduit element (400) and compression of the second component (302) to promote fluid flow through both end pieces (201, 202) of the connector (100), thereby causing the second predetermined pressure to cause fluid communication between the other end of the conduit element (400) and the fluid passageway of the second end piece (202) of the connector.

[0051] according to Figures 12 to 15 , the coaxial catheter element (400) has an upright catheter (401) with a hole (402) configured at its protruding end; and an opening (403) wider than the tip (401) at the opposite end. The catheter (401) extends from the hole (402) to the wider opening (404). In addition, the catheter element (400) has an extended annular portion (404) and a raised annular portion (405) outside the catheter (401), both of which are used to ensure engagement during assembly. After assembly, the end (404) with the wider opening is positioned and installed in the recess (311) of the second component (302) so that the opening (404) substantially covers the orifice or slit (310) of the second component (302). On the other hand, according to Figure 15 , the protruding end with the hole (402) is positioned and installed into the first component (301), wherein the raised annular portion (405) is horizontally aligned with the engagement member (306) when installed. After assembly and receiving the first predetermined compression of the connector, the connector is in a partially flow state ( Figure 4 ), wherein the protruding end of the conduit element (400) pushes the orifice or slit (304) of the first component (301) to an open state, while the wider opening (403) remains closed. After assembly and receiving a second predetermined compression of the connector, the connector reaches a fully open state, wherein the internal sleeve (211) pushes the orifice or slit (310) from the second component (302) to an open state, wherein the fluid inside can flow through the connector (100) in a linear channel within the end piece.

[0052] Generally speaking, the first predetermined compression of the elastic component puts the control valve into the partial flow state ( Figure 4), wherein the fluid flows into the fluid passage of the first end piece (201), but the fluid is kept flowing from the outlet through the fluid passage of the opposite second end piece (202), and the elastic component is continuously compressed further to a second predetermined compression to bring the control valve into a fully open state ( Figure 5 ), allowing fluid to flow through the fluid passage of the first end piece (201) and the second end piece (202) through the connector (100), and wherein disconnection of the connector (100) from the fluid passage is affected by multiple stages of relaxation of the elastic component to a fully relaxed state ( Figure 3 ) to shut off fluid flow through the connector. More specifically, releasing the second predetermined compression causes the fully open control valve to enter a partial flow state. In this state, the connector prevents bodily fluids from transferring from the distal end to the proximal end, for example, when an external device is disconnected from the proximal end. Then, further releasing the first predetermined compression causes the control valve to enter a fully relaxed state.

[0053] The first compression and the second compression herein are predetermined based on the design of the multi-stage fluid control valve (300). More specifically, the materials and / or dimensions used for the components (301, 302) can be adjusted during the manufacturing process. It should be understood that the materials and / or dimensions used provide sufficient rigidity and compressibility so that the multi-stage fluid control valve (300) does not leak during use.

[0054] The present invention may be embodied in other specific forms without departing from its essential characteristics. The described embodiments are to be considered in all respects only as illustrative and not restrictive. The scope of the present invention is, therefore, indicated by the appended claims rather than by the foregoing description. All modifications coming within the meaning and range of equivalence of the claims are intended to be included within their scope.

Claims

1. A fluid connector (100), characterized in that: A fluid connector for use as a medical interconnector in a fluid pathway, the fluid connector comprising, when assembled, two coaxial, interconnected end pieces (201, 202) forming two ends of the connector and extending through each end piece a fluid channel in each end piece, the channels together providing fluid communication between the opposite ends, A multi-position fluid control valve (300) is arranged in the interconnected end pieces (201, 202). When the fluid control valve is in a non-conducting state, the fluid passage flowing through the two end pieces (201, 202) through the connector (100) is closed. The control valve comprises an elastic compressible component (301, 302). The elastic compressible component (301, 302) can be activated so that The first predetermined compression of the elastic assembly (301, 302) causes the control valve (300) to enter a partial flow state, wherein the fluid flows into the fluid passage of the first end piece (201), but the fluid is maintained from the outlet through the fluid passage of the opposite second end piece (202), so that The continued second predetermined compression of the elastic component (301, 302) causes the control valve (300) to enter a fully open state, allowing fluid to flow through the fluid passages of the first and second end pieces (201, 202) through the connector (100), wherein The disconnection of the connector (100) from the fluid passage is effected by the elastic components (301, 302) relaxing from multiple stages to a fully relaxed state to prevent the fluid from flowing through the connector (100).

2. A fluid connector according to claim 1, characterized in that: The first end piece (201) is at least partially received within the second end piece (202), and wherein the first end piece (201) accommodates the elastically compressible component (301, 302).

3. A fluid connector according to claim 1 or 2, characterized in that: The elastically compressible component comprises a first component (301) and a second component (302), wherein the first component (301) mainly controls the flow of fluid in the fluid channel of the first end piece (201), and the second component (302) mainly controls the flow of fluid through the second end piece (202).

4. A fluid connector according to claim 4, characterized in that: The first component (301) is elastically movable within the first end piece (201) to open and close the fluid flowing therethrough, and wherein the second component (302) is also elastically movable within the first end piece (201) to open and close the fluid flowing therethrough.

5. A fluid connector according to claim 3 or 4, characterized in that: A portion of the fluid passage of the second end piece (202) extends into the fluid passage of the first end piece (201), thereby providing a portion of the fluid passage to the fluid passage of the first end piece (201).

6. A fluid connector according to claim 5, characterized in that: The second component (202) opens and closes fluid communication via a channel portion extending within the first end piece (201), thereby controlling the flow of fluid through the first end piece and the second end piece (201, 202).

7. A fluid connector according to any one of claims 4 to 6, characterized in that: A coaxial conduit element (400) is arranged in the first end piece (201) and between the first component (301) and the second component (302) of the elastic component, wherein the flow of fluid through one end of the conduit element (400) is controlled by the first component (301) and the flow of fluid through the other end of the conduit element (400) is controlled by the second component (302).

8. A fluid connector according to claim 7, characterized in that: The arrangement is such that a first predetermined pressure causes compression of the first component (301) to open fluid communication of the first end piece (201) through the conduit element (400), and wherein a second predetermined pressure causes axial movement of the conduit element (400) and compression of the second component (302) to promote fluid flow through the two end pieces (201, 202) of the connector (100).

9. A fluid connector according to claim 8, characterized in that: The second predetermined pressure creates fluid communication between the other end of the conduit element (400) and the fluid passageway of the second end piece (202) of the connector.

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