drug delivery connector and method of delivering liquid medication to a catheter connector

专利摘要:
SAFE DRUG DELIVERY CONNECTORS Drug delivery connectors are provided to allow and block fluid flow between a container and a catheter connector or other drug delivery site. The drug delivery connectors include a ball valve (190) to form a releasable seal within the drug delivery connectors. In one or more embodiments, the ball valve prevents fluid flow between an open proximal end and an open distal end of the drug delivery connector and the ball (190) is movable in a proximal direction to release the releasable seal to allow fluid flow from the open proximal direction to the open distal direction. Methods of delivering measurement to a catheter connector that includes an actuator (200) are also provided.
公开号:BR112012021414B1
申请号:R112012021414-4
申请日:2011-02-23
公开日:2021-04-20
发明作者:Yongxian Wu；Yun Jin；Mitali Aon；Michael D. Garrison
申请人:Becton Dickinson And Company；
IPC主号:

专利说明:

TECHNICAL FIELD
[001] Aspects of the present invention relate to drug delivery connectors that prevent medication delivery to incorrect delivery ports and to methods of using the drug delivery connectors. BACKGROUND
[002] Drug delivery devices typically share a common ISO standard luer connection, including intravascular, anesthesia, and enteral delivery devices. Incorrect connections of these pathways are possible and can cause medication error. The consequences of such mistakes can be adverse or even fatal.
[003] Previous attempts to reduce errors in drug delivery include the use of label or color coded devices to differentiate access devices to specific pathways (eg, catheter connectors) and devices or containers containing drugs to retain medication (eg , syringe cylinders). Studies have shown that clinicians tend to ignore these label and color codes. Other attempts to reduce error have required the use of valves with containers to prevent accidental connection and delivery. The operation of such valves often requires additional components to open the valve and/or securely attaching the valve to the container which can be cumbersome to attach and use. The use of some of these additional components to open the valve and/or securely attach the valve to the container, such as a syringe barrel, has also required the use of specialized syringe and/or catheter connections. In specific cases, valves can have complex structures that are difficult to manufacture and use and/or can use large surface areas on which menisci can form between the valve and the wall of the surrounding container within which the drug is stored. Additionally, the large surface area of the valves provides an increased opportunity for microbial growth, which can cause infection. Furthermore, typical valves are opened in the direction of fluid flow and/or are opened by containers that hold medication to be dispensed. For example, conventional valves can be opened by attaching a push rod to a syringe barrel filled with medication. The push rod activates the check valve in the direction of fluid flow (from the syringe barrel or other fluid or liquid container). In these configurations the syringe barrel cannot be attached to a standard hypodermic needle, which makes it impossible to pre-attach the push rod connector to the syringe. Additionally, such valves are generally intended to prevent back flow of fluid and can contaminate the source of medication.
[004] All of these problems can result in malfunction of the valve and drug delivery procedure. Furthermore, known devices do not allow the user to remove air from the container. Thus, there is a need for a drug delivery connector that can effectively eliminate all possibilities of misuse medication error for use in a variety of drug delivery procedures with standard syringes and other drug-containing devices. Additionally, there is a need for a drug delivery connector that allows normal aspiration of medication into a container and displacement of air, while providing a valve that prevents leakage of the aspirated medication. SUMMARY
[005] In this disclosure a convention is followed in which the distal end of the device is the end closest to a patient and the proximal end of the device is the end distal to the patient and closest to a practitioner.
[006] A first aspect of the present invention concerns a connector for drug delivery including a ball valve. In one or more embodiments, the drug delivery connector comprises a housing including an open distal end, an open proximal end and defining a chamber in fluid communication with the open distal end and the open proximal end. The housing may also include a proximal connecting portion for securing the housing to a container and a distal connecting portion. The distal connecting part and/or the proximal connecting part may include a luer lock fitting or a luer sliding fitting. The ball valve is disposed within the chamber and forms a releasable seal with the open distal end of the drug delivery connector to prevent fluid flow from the open proximal end of the housing to the open distal end of the housing.
[007] The housing also includes a structure to form one or more fluid flow paths around the ball valve. The structure can be a longitudinal bulge, a rib, an expanded sidewall and/or combinations thereof. The housing chamber may also include a retaining ring that inhibits movement of the ball valve within the chamber in the proximal direction.
[008] The housing of one or more modalities may also include a proximal wall disposed adjacent to the open proximal end of the drug delivery connector. The proximal wall includes at least one opening allowing constant fluid communication between the open proximal end and the housing chamber. The housing may also include a distal wall disposed adjacent the open distal end of the drug delivery connector that includes a bore having a perimeter that is configured to contact the ball valve to form a releasable seal between the ball valve and the distal wall. .
[009] In one or more embodiments, the ball valve is movable in a proximal direction to release the releasable seal formed with the distal wall and to allow fluid flow from the open proximal end to the open distal end by applying a force to the proximal direction over the ball valve. In a specific embodiment, the ball valve is movable in a distal direction to form the releasable seal with the distal wall by applying a force in the distal direction on the ball valve. According to one or more embodiments, attachment of a container including a fluid to the proximal connecting portion of the housing causes fluid retained within the container to apply force to the ball valve in the distal direction to move the ball valve in the distal direction. . The force applied to the ball valve causes the ball valve to form a releasable seal with the distal end open.
[010] In one or more embodiments, the drug delivery connector may include an actuator attachable or for attachment to the open distal end of the housing. The actuator includes an open distal end and a projection extending proximally from the open distal end. In one or more embodiments, the projection includes at least one opening in fluid communication with the open distal end of the actuator and the open distal end of the housing. Upon attaching the actuator to the open distal end of the housing, the projection extends through the distal wall hole into the chamber and applies a force on the ball valve in the proximal direction to move the ball valve in the proximal direction. In one or more embodiments, the ball valve is movable in the proximal direction by applying a minimum or predetermined force on the ball valve in the proximal direction. In one or more embodiments, a coil spring or other device can be disposed within the housing to exert a constant force on the ball valve in the distal direction. The coil spring spring constant can be adjusted or selected to select the minimum or predetermined force required to release the seal between the ball valve and the distal wall.
[011] According to a second aspect of the present invention, the drug delivery connector includes a housing including an open distal end, an open proximal end, and a chamber in fluid communication with the open distal end and the open proximal end device for attaching the housing to a catheter connector comprising an actuator, device for attaching the housing to a container, and device for allowing and blocking fluid communication between the container and the catheter connector from the open proximal end to the open distal end. In one or more embodiments, the device for allowing and blocking fluid communication comprises a ball valve. In a specific embodiment, the device for allowing and blocking fluid communication comprises a spring-loaded ball valve.
[012] A third aspect of the present invention concerns a method of delivering liquid medication to a catheter connector. In one or more embodiments, the method includes attaching an actuator, as described herein, to a catheter, providing a drug delivery connector with a housing with an open distal end, an open proximal end, and a chamber with a valve, as described herein, in fluid communication with the open distal end and the open proximal end of the housing, attach a tip of a syringe barrel to the open proximal end of a drug delivery connector, fill the syringe barrel with a predetermined amount of liquid medication, filling the drug delivery connector chamber with the liquid medication to form a seal between the valve and the open distal end and releasing the seal between the valve and the open distal end by securing the open distal end to the actuator. In one or more embodiments, the actuator includes a projection with a length that extends into the housing chamber. The projection may include an open path in fluid communication with the catheter connector. The step of releasing the seal between the valve and the open distal end may include having the actuator projection apply a force to the valve in a proximal direction. In one or more embodiments, the step of releasing the seal between the valve and the open distal end allows liquid medication to flow from the chamber into the open path of the projection. BRIEF DESCRIPTION OF THE DRAWINGS
[013] Figure 1 illustrates a disassembled perspective view of one or more modalities of the connector for drug delivery shown with a syringe barrel and an actuator; Figure 2 illustrates a perspective view of the drug delivery connector shown in Figure 1 assembled with the actuator; Figure 3 illustrates an enlarged view of the drug delivery connector and actuator shown in Figure 1; Figure 4 illustrates a perspective cross-sectional view of the drug delivery connector and actuator shown in Figure 3 taken along line 4-4 from the distal end view of the drug delivery connector and actuator; Figure 5 shows a cross-sectional perspective view of the drug delivery connector shown in Figure 4; Figure 6 illustrates a side elevation view of the drug delivery connector shown in Figure 5; Figure 7 shows a perspective cross-sectional view of the drug delivery connector shown in Figure 4 including a distal wall in accordance with one or more embodiments of the present invention, a ball valve, and a coil spring; Figure 8 shows a view of the drug delivery connector shown in Figure 7 including a distal wall and side wall in accordance with one or more embodiments of the present invention and a ball valve; Figure 9 shows a view of the drug delivery connector shown in Figure 7 including a distal wall and side wall in accordance with one or more embodiments of the present invention and a ball valve; Figure 10 shows a view of the drug delivery connector shown in Figure 7 including a distal wall and side wall in accordance with one or more embodiments of the present invention and a ball valve; Figure 11 shows a view of the drug delivery connector shown in Figure 7 including a distal wall and side wall in accordance with one or more embodiments of the present invention and a ball valve; Figure 12 shows a view of the drug delivery connector shown in Figure 7 including a distal wall and side wall in accordance with one or more embodiments of the present invention and a ball valve; Figure 13 illustrates a cross-sectional view of the proximal end of the drug delivery connector shown in Figure 4 taken along line 13-13 including a proximal wall in accordance with one or more embodiments of the present invention; Figure 13A shows a perspective view of the drug delivery connector shown in Figure 13; Figure 14 shows the proximal end of the drug delivery connector shown in Figure 13 including a proximal wall in accordance with one or more embodiments of the present invention; Figure 14A shows a perspective view of the drug delivery connector shown in Figure 14; Figure 15 shows the proximal end of the drug delivery connector shown in Figure 13 including a proximal wall in accordance with one or more embodiments of the present invention; Figure 15A shows a perspective view of the drug delivery connector shown in Figure 15; Figure 16 shows a cross-sectional perspective view of a drug delivery connector according to one or more embodiments; Figure 17 illustrates a cross-sectional view of a drug delivery connector attached to a syringe barrel and a needle hub positioned with a vial for drawing liquid into the syringe barrel; Figure 18 shows the drug delivery connector, syringe barrel and needle hub shown in Figure 17 as liquid is being drawn from the vial into the syringe barrel; Figure 19 illustrates a cross-sectional view of the drug delivery connector and syringe barrel shown in Figure 18 filled with liquid; Figure 20 shows a cross-sectional view of the drug delivery connector shown in Figure 5 assembled with a syringe and an actuator disassembled in accordance with one or more embodiments; Figure 21 shows an enlarged partial view of the drug delivery connector, syringe and actuator shown in Figure 20; Figure 22 illustrates the drug and syringe delivery connector and actuator of Figure 20 in an assembled state; and Figure 23 illustrates an enlarged partial view of the drug delivery connector, syringe and actuator shown in Figure 22. DETAILED DESCRIPTION
[014] Before describing various exemplary embodiments of the invention, it is to be understood that the invention is not limited to the construction details or process steps set out in the description below. The invention is capable of other modalities and of being practiced or executed in various ways.
[015] Aspects of the present invention relate to connectors for drug delivery. Drug delivery connectors can be used to deliver medication from a container to a delivery site to deliver to a patient intravenously or via the epidural space. Exemplary containers include syringe cylinders, IV bags or other medical devices used to store, transport and/or deliver anesthesia. In one or more embodiments, the drug delivery connector provides a fluid-tight connection mechanism between a delivery location and a container. In a specific embodiment, the drug delivery connector provides a fluid-tight connection mechanism between a catheter connector or other delivery site and a syringe barrel. The fluid-tight connection mechanism between a delivery location and a drug container may include a filter. Examples of connection mechanisms used to connect a syringe barrel and delivery location to the drug delivery connectors described in this document include standard luer slide fittings or standard luer lock fittings. The drug delivery connectors described herein include a structure to prevent flow of medication from the container when attached to an inappropriate delivery location and allow flow of medication from the container when attached to an appropriate delivery location.
[016] According to one or more embodiments, the drug delivery connector includes a ball valve disposed in the medication flow path from a container to a delivery location. The ball valve of one or more modes forms a one-way valve or a check valve. As used in this document, the term “one-way valve” includes any valves that allow fluid to flow in one direction. As used in this document, the term "check valve" may be used interchangeably with the term "one-way valve". In a specific modality, the ball valve is activated or opened by means of an actuator, which can be in the form of a push rod, and cannot be activated or opened by the container or even the delivery location. In a more specific embodiment, the ball valve is activated by the actuator, which may include a catheter connector for connecting the drug delivery connector and container to a catheter or other delivery site. The ball valve prevents fluid flow through the drug delivery connector from the container to the actuator and thus to the delivery location. The ball valve allows the user to attach the drug delivery connector to at least one of the container and/or actuator without accidental expulsion of medication from the container. Additionally the drug delivery connector can be used with containers without fear of leakage or accidental administration of the medication contained therein.
[017] A drug delivery connector 100 according to a first aspect is shown in figures 1-6. As shown more clearly in Figures 4-6, the drug delivery connector 100 includes an open distal end 101 and an open proximal end 109. The drug delivery connector includes a housing 110, a distal connecting portion 150 extending from housing 110 to the open distal end 101 of the drug delivery connector and a proximal connection portion 170 extending from the housing 110 to the open proximal end 109 of the drug delivery connector. Distal connecting portion 150 is in fluid communication with housing 110 and proximal connecting portion 170.
[018] For illustration in Figures 1-6, a container in the form of a syringe barrel 300 is used with the drug delivery connector 100, although the drug delivery connector according to one or more modalities may also be used with other types of containers, for example an IV bag. Furthermore, an actuator 200 including a catheter connector 210 is also included for illustration.
[019] As shown more clearly in Figures 4-5, the distal connecting portion 150 includes a distal end 151 and a proximal end 159 including a distal luer fitting for securing the actuator 200 to the connector for drug delivery. In one or more embodiments, the distal connecting portion 150 of one or more embodiments may include a fitting in the form of a luer slip fitting (not shown) for connection to an actuator 200. In the embodiment shown in Figures 1-6, the distal connection portion 150 includes a fitting in the form of a luer lock fitting including an elongated tube 152 in fluid communication with the housing 110 and extending from the housing 110 to the open distal end 101 of the drug delivery connector. Elongated tube 152 includes an outer surface 154 and a coaxial wall 156 surrounding the elongated tube 152 and defining an inner surface 158 that forms a channel 160 between the inner surface 158 of the coaxial wall 156 and the elongated tube 152. In one or more embodiments , the inner surface 158 of the coaxial wall 156 includes a threaded portion 162 for engaging with the actuator 200. The elongated tube includes an inner surface 153 defining a passage 155 for receiving the actuator 200 (as shown more clearly in Figure 4) . Actuator 200 which is shown in figures 1-4 and 20-22 is an example of one or more suitable actuators for activating ball valve 190 and includes catheter connector 210 for attaching actuator 200 to a filtration system, catheter or other delivery location. In use, the actuator 200 is inserted into the passage 155 of the distal connecting portion 150 of the drug delivery connector. As will be described in further detail below, the actuator 200 may also include a mating structure that allows the actuator 200 to be screwed onto the threaded portion 162 of the distal connecting portion 150 of the drug delivery connector 100. Into one or more In embodiments, the flow rate of medication flowing from the container through the drug delivery connector 100 and to the actuator 200 can be modified or controlled by controlling the level of engagement between the actuator 200 and the drug delivery connector 100. In more specific embodiments, the flow rate can be controlled by controlling the amount of rotation applied to the actuator 200 relative to the drug delivery connector 100 during clamping.
[020] As shown in the embodiment in Figures 4-5, the proximal connecting portion 170 of the drug delivery connector extends from the housing 110 to the open proximal end 109 of the drug delivery connector 100. The proximal connecting portion 170 includes a proximal luer fitting in the form of an elongated hollow body 172 having an open distal end 171, an open proximal end 179 and an inner surface 173 defining an interior 175 for receiving and engaging an opening of a container, e.g., a tip. 314 of the syringe barrel 300 shown in Figure 1. In one or more embodiments, the elongated hollow body 172 includes an outer surface 176 with at least one radially outwardly extending ridge 177 disposed adjacent the open proximal end 179. In the embodiment shown , elongate hollow body 172 includes two ridges 177, 178 disposed at opposite ends of the proximal end of elongated hollow body 172. In one or more embodiments, the at least one radially extending ridge 177 may extend radially along a portion of the circumference of the open proximal end 179 or the entire circumference of the open proximal end 179. The at least one radially outwardly extending ridge 177 allows mounting the connector for drug delivery 100, and more specifically the proximal connecting portion 170, into a container, e.g. syringe barrel 300 shown in Figure 1, which may have a luer lock attachment 310 including open tip 314 and a threaded section 312 surrounding open tip 314, as shown in figures 1 and 17-18. To mount the syringe barrel 300 with a luer lock attachment 310 to the proximal connecting portion 170 of the drug delivery connector 100, the open end 314 is inserted into the open proximal end 179 of the elongated hollow body 172 and the syringe barrel 300 and/or the drug delivery connector 100 is rotated relative to one another. During rotation, threaded section 312 of luer lock attachment 310 engages with at least one radially outwardly extending ridge 177. In the embodiment shown in Figure 18, threaded section 312 engages with both radially outwardly extending ridges 177, 178 of the proximal connecting portion 170.
[021] In one or more embodiments, the proximal connection portion 170 may allow connection of the drug delivery connector 100 to a syringe with a luer sliding tip (not shown). In such embodiments, the inner surface 173 of the elongated hollow body 172 of the proximal connecting portion 170 may have a transverse sectional width that increases along the length of the elongated hollow body 172 from the open distal end 171 to the open proximal end 179, forming a tapered portion (not shown) that frictionally engages the sliding luer tip (not shown) of a syringe barrel. To mount a syringe barrel having a luer sliding tip (not shown) on the proximal connecting portion 170 of the drug delivery connector, the luer sliding tip (not shown) of the syringe barrel is fitted to the interior 175 of the elongated hollow body 172. A force in the distal direction is applied to the syringe barrel relative to the drug delivery connector 100 until the tapered portion (not shown) of the elongated hollow body 172 and the inner surface 173 prevent further movement of the syringe tip. luer slide (not shown) in the distal direction relative to the drug delivery connector 100 and the luer slide tip (not shown) is frictionally engaged with the inner surface 173 of the proximal connection portion 170.
[022] The housing 110 includes a sidewall 112 having an axial length and an inner surface 114 defining the chamber 116. In one or more embodiments, the chamber 116 is cylindrically shaped and has a distal end 111 in fluid communication with the open distal end 151 of the distal connecting portion 150 and a proximal end 119 in fluid communication with the open proximal end 179 of the proximal connecting portion 170. In one or more embodiments, the distal end 111 includes a distal wall 130 disposed between the chamber 116 and the distal connecting portion 150. The distal wall 130 includes at least one hole 132 therethrough having a perimeter 134 to allow fluid communication between the distal connecting portion 150 and the chamber 116. The proximal end 119 includes a proximal wall 140 disposed between chamber 116 and proximal connecting portion 170. The proximal wall 140 includes at least one opening 142 to allow fluid communication between the pair. proximal connecting port 170 and chamber 116. As will be described in more detail below, the proximal wall 140 has a structure to prevent the formation of a seal that closes the opening 142 or, in other words, a structure that maintains communication of fluid between a container and chamber 116 when the container is attached to drug delivery connector 100.
[023] In the embodiment shown in Figures 1-6, the chamber 116 of the housing 110 includes a ball valve 190. As will be described in more detail below, the ball valve 190 cooperates with an actuator 200 to allow fluid communication between syringe barrel 300, drug delivery connector 100, and a delivery site that may include a catheter (not shown) and/or filter (not shown). Ball valve 190 cooperates with distal wall 130 to prevent fluid communication between chamber 116 and through hole 132 of distal connecting portion 150. According to one or more embodiments, ball valve 190 remains closed and prevents communication of fluid between the chamber 116 and the distal connecting portion 150 when the drug delivery connector 100 is secured to a syringe barrel 300 that is filled with medication because the pressure of the medication contained within the syringe barrel 300 applies a continuous force. over ball valve 190 in the distal direction to close ball valve 190 against distal wall 130.
[024] In one or more embodiments, the ball valve 190 is sized to fit within the chamber 116 of the housing 110 and has a solid spherical shape and circular cross section having a dimension and shape to create a releasable seal with the distal wall 130 , thus closing bore 132 and preventing fluid communication between chamber 116 and distal connecting portion 150. Ball valve 190 may be formed of a rubber, plastic, metal or ceramic material or combinations thereof. In one or more specific embodiments, the ball valve 190 can be formed from a synthetic rubber and/or a polyurethane material. In a specific embodiment, the ball valve 190 may be formed of a plastic or other commonly used material and coated with synthetic rubber or other polyurethane-containing materials. Ball valve 190 “floats” or is movable within the chamber in both proximal and distal directions. Forces such as gravity can cause the ball valve 190 to move in either the proximal or distal direction. Other forces such as fluid pressure can cause ball valve 190 to close bore 132 or move in the distal direction to form a seal with perimeter 134 of distal wall 130.
[025] Embodiments of the present invention utilize the 190 ball valves with a reduced surface area in place of other valves known and used in the art. A reduced surface area eliminates the problems with regard to ball valve movement within chamber 116 and reduces the possibility of meniscus formation between ball valve 190 and chamber 116, which can further inhibit movement of ball valve 190 The reduced surface area of the ball valve 190 also reduces the possibility of microbial formation on the surface of the ball valve 190, which can be especially problematic when the drug delivery connector 100 is used with implanted medical devices such as catheters, which can remain in place for several days at a time. Furthermore, the spherical shape of the ball valve 190 facilitates manipulation of the ball valve 190 and eliminates problems of misalignment of the ball valve 190 within the chamber 116 because of varying forces exerted at different locations on the ball valve 190.
[026] According to one or more embodiments, the ball valve 190 can be spring-loaded. A drug delivery connector including a coil spring 192 disposed within chamber 116 of housing 110 is shown in Figure 8. Coil spring 192 includes a distal end 193 disposed adjacent the ball valve 190 and a proximal end 194 disposed adjacent the wall. proximal 140. In a deactivated state, coil spring 192 is expanded, and applies a constant force on ball valve 190 in the distal direction, forcing ball valve 190 to remain in contact with distal wall 130 sealing bore 132. Other structures known to apply a constant force on the ball valve can also be used. To open the ball valve 190, the user applies a force on the ball valve 190, from the side opposite the coil spring 192, in the proximal direction. The proximally directed force applied to ball valve 190 compresses coil spring 192 and forces ball valve 190 to move away from distal wall 130 to allow fluid communication between housing chamber 116 and bore 132 in distal wall 130 In one or more embodiments, the coil spring spring constant can be adjusted to require a minimum or predetermined amount of force to activate or open the ball valve.
[027] To form a seal with bore 132 of distal wall 130, ball valve 190 is seated adjacent bore 132 and in contact with distal wall 130. In one or more embodiments, bore 132 has a transverse sectional width forming a seat that receives the ball valve 190. In one or more embodiments, for example, as shown in Figure 6, the distal wall 130 is disposed vertically or is disposed perpendicularly to the side wall 112 of the chamber 116 to form a distal wall 130 having a flat configuration. The contact between the ball valve 190 and the distal wall 130 with a flat configuration can be described as a line of contact.
[028] In a specific embodiment, the distal wall 130 may be contoured adjacent the perimeter 134 and the hole 132 to further facilitate the formation of a seal between the distal wall 130 and the ball valve 190. According to one or more embodiments As shown in Figures 7 and 8, the distal wall 130 may include a bevel 135 forming a beveled seat 136 for the ball valve 190. The bevel 135 allows for a greater contact surface area between the ball valve 190 and the distal wall 130. In such a configuration, defects or modifications to the surface of the distal wall 130 are not as likely to compromise the seal formed between ball valve 190 and distal wall 130 as are configurations that provide a smaller contact surface area. between the ball valve and the distal wall 130.
[029] In one or more embodiments, as shown in Figure 9, the distal wall 130 may extend proximally into the chamber 116 to form a sharp contact point 137 forming a "sharp contact" with the ball valve 190. Sharp contact between the sharp contact point 137 and the ball valve 190 is formed when the distal wall 130 is positioned at an angle of less than 90 degrees to the side wall 112. In other words, during sharp contact between the valve. ball 190 and the sharp contact point 137 form a single line of contact with the ball valve 190. The single line of contact lessens the likelihood that a defect in the distal wall 130 and/or the ball valve 190 will interfere with formation. of a fence. The decreased contact area between ball valve 190 and perimeter 134 increases pressure on ball valve 190 and compresses ball valve 190. This compression improves the seal formed between distal wall 130 and ball valve 190. Compression of the ball valve 190 is particularly pronounced when the ball valve 190 is composed of a softer material or material with less elasticity, because it allows dispersion of the force exerted on the ball valve 190, which is thus not possible when the valve of sphere is made up of more rigid materials.
[030] In one or more embodiments, the chamber 116 of the housing 110 can be modified to align the ball valve 190 in the center of the fluid path. For example, in one or more embodiments, inner surface 114 may include one or more structures or structural features that permit movement of ball valve 190 in the proximal and distal directions within chamber 116, but prevent lateral movement of ball valve 190. In Figure 6, inner surface 114 of sidewall 112 includes at least one longitudinal protrusion 120 extending radially outwardly within chamber 116 of housing 110. Longitudinal protrusion 120 defines a transverse sectional width less than the transverse sectional width defined by inner surface 114 of sidewall 112. The reduced transverse sectional width defined by longitudinal protuberance 120 prevents or reduces lateral movement of ball valve 190 toward sidewall 112, while providing a flow path for fluid to flow past the valve. of ball valve 190 when the seal between the distal wall 130 and the ball valve 190 is yelled.
[031] In one or more embodiments, the transverse sectional width of the inner surface 114 of the chamber 116 and the transverse sectional width of the ball valve 190 are sized to allow movement of the ball valve 190 distally and proximally within the chamber 116, but they prevent lateral movement of the ball valve 190 towards the side wall 112 of the housing, which can occur when the medication flow rate is low and less pressure is being exerted on the ball valve 190 in the distal direction.
[032] In one or more embodiments, a plurality of longitudinal protuberances 121 are provided along the length of housing 110, as shown in Figures 7-8. The plurality of longitudinal protuberances 121 reduce the transverse sectional width of the chamber 116 within which the ball valve 190 can move in the proximal and distal directions, but provide multiple flow paths for fluid to flow past the ball valve 190 when the seal between perimeter 134 of distal wall 130 and ball valve 190 is released.
[033] The length, dimensions and/or placement of the longitudinal protrusions or other similar structure can be modified according to the needs of a particular application. For example, if the drug delivery connector is used with a medication that is more viscous, larger or more flow paths may be needed to facilitate flow between the container and the delivery site. In another example, in one or more embodiments, as shown in Figure 10, the inner surface of the chamber may include a plurality of ribs 122 extending from the distal wall 130 to a proximal wall 140 to align the ball valve 190 at the center. of the fluid path without significantly reducing the flow rate of medication flowing from a container through the drug delivery connector 100. As shown in Figure 10, the plurality of ribs 122 provide additional fluid flow paths for the fluid, a once the seal between the distal wall 130 and the ball valve 190 is released. The plurality of ribs 122 are configured to allow rotational and non-rotational movement of the ball valve 190 in the distal and proximal directions within the chamber. In a specific embodiment, the inner surface 114 of the chamber 116 includes two or more ribs (not shown) that allow fluid communication between the distal connecting portion 150 and the chamber 116 when sealing between the ball valve 190 and the distal wall 130 is released.
[034] In a specific embodiment, as shown in Figure 11, the transverse sectional width of the inner surface 114 of the sidewall 112 may increase from the distal connecting portion 150 to the proximal connecting portion 170. In one or more embodiments, the sectional width of the inner surface 114 of the sidewall 112 may increase linearly. In the embodiment shown in Figure 10, housing 110 includes an expanded sidewall 123 including an inner surface 124 defining a transverse sectional width that increases substantially linearly or constantly from distal end 111 to proximal end 119 of the housing. In the embodiment shown in Figure 11, the transverse sectional width of the sidewall 112 "gradually" increases along the axial length of the sidewall 112. In such embodiments, the sidewall 112 has a first portion 125 extending from the distal wall 130. along the axial length of the side wall 112 by a first length and a second part 126 extending from the first part 125 to the proximal wall 140. The transverse sectional width of the first part 125 may be less than the transverse sectional width of the second part 126 In one or more embodiments, the transverse sectional width of the first portion 125 may increase from the distal wall 130 to the second portion 126 or remain constant. In one or more embodiments, the transverse sectional width of second portion 126 may increase from first portion 125 to proximal wall 140 or may remain constant. In another embodiment, the transverse sectional width of the first part 125 and that of the second part 126 increases at the same or different rates. As shown in Figure 11, a transitional portion 118 may be included between the first portion 125 and the second portion 126. In the embodiment shown, the cross-sectional width of the first portion 125 is smaller than that of the second portion 126, but it is constant. from distal wall 130 to transition portion 118. Second portion 126 is shown as having a greater transverse sectional width than first portion 125, but is constant from transition portion 118 to proximal wall 140 with the transition part 118 having a transverse sectional width which increases from the first part 125 to the second part 126.
[035] In one or more embodiments, sidewall 112 of chamber 116 may include one or more structural features to align the ball valve to the center of the fluid path. These structural features may also exert a distally directed force on the ball valve 190 to prevent the ball valve 190 from moving in the proximal direction when the force exerted on the ball valve varies, for example, during air displacement or the removing air from inside the syringe or container and before delivering the medication to the intended delivery location. In one or more embodiments, these structural features prevent movement of ball valve 190 in the proximal direction and require the application of greater force on ball valve 190 to move ball valve 190 in the proximal direction. In one or more embodiments, a structural feature that prevents movement of the ball valve 190 in the proximal direction is shown in Figure 12. In Figure 12, the sidewall 112 of the housing 110 defines a radial length or circumference and includes a retainer ring 127. extending radially into chamber 116. Retaining ring 127 may be formed along distinct portions of the radial length of sidewall 112 or, alternatively, along the entire radial length of sidewall 112. In one or more embodiments, the retaining ring 127 includes a perpendicular wall 128 extending radially into chamber 116 from side wall 112 that defines a transverse sectional width along retaining ring 127 that is less than the transverse sectional width of side wall 112. In one or more embodiments, perpendicular wall 128 includes a beveled inner edge 129. In such embodiments, beveled inner edge 129 may define a transverse sectional width that increases in the proximal direction along the axial length of the perpendicular wall 128. In an alternative embodiment, the beveled inner edge 129 may define a transverse sectional width that decreases in the proximal direction. In one or more embodiments, the beveled inner edge 129 retains the ball valve 190 in the closed position in contact with the perimeter 134 of the distal wall 130 by forming a physical barrier for movement of the ball valve 190 in the proximal direction. In one or more embodiments, the perpendicular wall may include a flat inner edge (not shown) that defines a constant transverse sectional width along the axial length of the perpendicular wall 128.
[036] In yet another specific embodiment, the inner surface 114 of the chamber 116 and/or the retaining ring 127 may include one or more raised portions (not shown) extending radially that also form a physical barrier to movement of the valve. ball 190 in the proximal direction, but also provide an open flow path for medication to flow from a syringe barrel through the drug delivery connector 100 when the drug delivery connector 100 is secured to an actuator and the seal between the valve. ball 190 and the perimeter 134 of the distal wall 130 is released. In one or more embodiments, the height of the raised parts (not shown) can be adjusted to exert more or less pressure on the ball valve in the distal direction. For example, the height and/or shapes of the raised parts can be increased to exert a greater force on the ball valve in the distal direction and/or to form a physical barrier that is more difficult to overcome than raised parts having a decreased height. . In one or more embodiments, the raised portions may also be chamfered to exert an even greater force on the ball valve in the distal direction to prevent proximal movement of the ball valve. The chamber of one or more embodiments may include a combination of the longitudinal protuberance 120, the plurality of the longitudinal protuberances 121, the expanded sidewall 123, the retaining ring 127, and/or the plurality of the raised portions (not shown).
[037] The opening 142 of the proximal wall 140 of the housing 110 enables fluid communication between the chamber 116 and the open proximal end 179 of the proximal connecting portion 170. In one or more embodiments, the proximal wall 140 may include more than one opening 142. As shown in Figures 13-15, the proximal wall 140 may also include a structure to prevent the formation of a seal between the ball valve 190 and the opening 142. In other words, the proximal wall 140 includes a structure that maintains fluid communication between the chamber 116 and the proximal connecting portion 170. In one or more embodiments, the proximal wall 140 may include an irregular contour or geometry that prevents the formation of a seal between the ball valve 190 having a spherical geometry. regular.
[038] In one or more embodiments, the proximal wall 140 may include a series of telescopic conduits extending in a fixed position relative to one another and extending from chamber 116 to proximal connecting portion 170. Figures 13-15 illustrate embodiments using telescopic conduits that surround opening 142 and define a conduit space. In such embodiments, a first conduit 143 extends in the proximal direction from sidewall 112 of housing 110 and defines a first transverse sectional width, a second conduit 144 defining a second transverse sectional width extends from first conduit 143 in the proximal direction and a third conduit 145 defining a third transverse sectional width extends from the second conduit 144 in the proximal direction. In one or more embodiments, the telescopic conduits have varying axial lengths extending in the proximal direction. The transverse sectional widths defined by the telescopic conduits can be further reduced from the first conduit 143 to the third conduit 145 which has a smaller transverse sectional width. For example, the first transverse sectional width of the first conduit 143 may be greater than the second transverse sectional width of the second conduit 144. In one or more embodiments, the second transverse sectional width of the second conduit 144 may be greater than the third transverse sectional width of the third conduit 145.
[039] In one or more embodiments, the first conduit 143 may include the first inner surface 146 defining a first conduit space in fluid communication with the opening 142. The first inner surface includes one or more partially extending guide bars 148 to the first flue space. In one or more embodiments, the one or more guide bars 148 extend along the axial length of first conduit 143 and are disposed at equal distances along first inner surface 146. In one or more embodiments, second conduit 144 may include a second inner surface 147 defining a second conduit space and include at least one crossbeam 149 extending through opening 142, crossing opening 142 at two openings along the axial length of second conduit 144. shown in Figures 14 and 14A, second conduit 144 includes two transverse beams 149 extending from equally spaced points along the second inner surface 147 of second conduit 144 and crossing at a center point at opening 142, crossing opening 142 at four openings. dimensioned equally along the axial length of the second conduit 144. In the embodiment shown in Figures 15 and 15A, the second conduit 144 includes three beams. the crossbeams 149 extending from evenly spaced points along the second inner surface 147 towards a midpoint in the opening 142. The three crossbeams 149 shown in Figures 15 and 15A cross the opening 142 at three equally sized gaps along the length axial length of second conduit 144. In one or more embodiments, the beam or crossbeams 149 has an axial length that extends along the axial length of second conduit 144 and occupies the second conduit space. In a more specific embodiment, the beam or crossbeams 149 may have an axial length that extends beyond the axial length of the second conduit 144 and extends into the first conduit space of the first conduit 143. Figures 13A, 14A and 15A illustrate one or more transverse beams 149 extending into the first conduit space. In one or more embodiments, third conduit 145 is free of any additional structures and surrounds opening 142 adjacent to proximal connecting portion 170.
[040] The arrangements of guide bars 148, first conduit 143, second conduit 144, third conduit 145 and/or cross beam 149 prevent formation of a seal between ball valve 190 and proximal wall 140 because they do not provide a circular edge with which the ball valve 190 can form a contact line interaction. Instead the guide bars 148, the first conduit 143, the second conduit 144, the third conduit 145 and/or the crossbeam 149, alone or in combination, form an irregular edge or irregular contact points with the ball valve 190 which prevent the formation of a seal between the ball valve 190 and the proximal wall 140.
[041] In one or more alternative embodiments, the proximal wall 140 may include a plurality of telescopic walls (not shown) extending proximally in a fixed configuration and surrounding the opening 142 to prevent formation of a seal between the ball valve and the proximal wall. The plurality of telescopic walls including a first annular wall (not shown) disposed adjacent the side wall of the housing, a second annular wall (not shown) between the first annular wall and a third annular wall (not shown). In one or more embodiments, the third annular wall (not shown) is disposed between the second annular wall (not shown) and the opening 142. The first annular wall (not shown), second annular wall (not shown) and/or third annular wall (not shown) may have a thickness that elongates chamber 116 and extends chamber 116 at least partially into the interior 175 of proximal connection portion 170. The first annular wall (not shown) may have a first thickness and the second annular wall may have a second thickness, wherein the first and second thicknesses may be the same or different. The third annular wall (not shown) may be formed integrally with the proximal connecting portion 170 and may define opening 142.
[042] In one or more embodiments, the first annular wall (not shown) may include a plurality of detents (not shown) that extend inwardly into the second annular wall (not shown). The plurality of detents (not shown) are shaped and arranged to prevent formation of a seal between the ball valve 190 and the proximal wall 140. In one or more embodiments, the plurality of detents (not shown) may be disposed on the second wall annular (not shown) and extend inward on the third annular wall (not shown). The plurality of detents (not shown) may be disposed equidistant from opening 142 and one another along the perimeter of one or more of the first annular wall (not shown), second annular wall (not shown) and/or third annular wall (not shown). In one or more specific embodiments, four detents can be used and can be arranged along the first annular wall (not shown) so that they extend inwardly and on the second annular wall (not shown).
[043] In one or more embodiments, one or more of the first annular wall (not shown), second annular wall (not shown) and/or third annular wall (not shown) may include at least one transverse beam extending through the opening from opposite ends of the wall. In a specific embodiment, the second annular wall may include a single cross beam affixed to opposite sides of the second annular wall (not shown) and extending through the opening 142. The second annular wall may also include two cross beams (not shown) that intersect at the midpoint of opening 142 and divide at least one opening 142 into four openings. In a more specific embodiment, the second annular wall may include three crossbeams (not shown) extending into opening 142 and crossing at a midpoint of opening 142. In such embodiments, three crossbeams (not shown) divide the at least one opening 142 in three openings. The crossbeam (not shown) can be lifted from the annular wall on which it is formed and/or connected and thus extends proximally into the chamber. In other words, the crossbeam (not shown) may extend proximally from the first annular wall (not shown), second annular wall (not shown) and/or the third annular wall (not shown) into the chamber 116 to create a uneven surface or seat for the ball valve 190 adjacent the first, second and/or third annular walls.
[044] The arrangements of detents (not shown), first annular wall (not shown), second annular wall (not shown), third annular wall (not shown) and/or cross beam (not shown) described in this document prevent formation of a seal between ball valve 190 and proximal wall 140 because they do not provide a circular edge with which ball valve 190 can form a line-of-contact interaction. Instead the detents (not shown), first annular wall (not shown), second annular wall (not shown), third annular wall (not shown) and cross beam (not shown) form an irregular edge or irregular contact points. with the ball valve 190, which together and individually prevent the formation of a seal between the ball valve 190 and the proximal wall 140.
[045] In alternative embodiments, the proximal wall 140 may use another device to prevent formation of a seal between the ball valve 190 and the at least one opening 142. For example, the proximal wall 140 may include a plurality of openings (not shown) dispersed along the proximal wall 140. In this embodiment, the at least one opening 142 disposed along the proximal wall 140 remains open regardless of the position of the ball valve 190. In one or more embodiments, as shown in Figure 16, proximal wall 140 may include one or more protrusions 141 extending distally into chamber 116 that prevent ball valve 190 from forming a seal with proximal wall 140.
[046] An actuator 200 may be provided with the drug delivery connector 100 separately or pre-attached to a catheter connector 210. A syringe barrel 300 and/or a hypodermic needle 400 which may include a metal cannula or plastic that can be blunted, may also be supplied separately or attached to the drug delivery connector 100. The hypodermic needle 400 may be provided with a needle hub 410, as shown in Figure 17. In one or more embodiments, the drug delivery connector 100, syringe barrel 300, and hypodermic needle 400 are provided in one kit. In a specific embodiment, the drug delivery connector 100, syringe barrel 300, hypodermic needle 400 and actuator 200 can be provided in a kit. In a more specific embodiment, drug delivery connector 100, syringe barrel 300, hypodermic needle 400, actuator 200, and catheter connector 210 can be provided in a kit. In one or more embodiments, catheter connector 210 can optionally include a filter. Alternatively, drug delivery connector 100, syringe barrel 300, actuator 200, catheter connector 210, hypodermic needle 400 and/or filter may be provided separately.
[047] In one or more alternative embodiments, the drug delivery connector is connected to a syringe barrel. The drug delivery connector can be pre-attached to the syringe by the device manufacturer. The syringe barrel can be pre-filled or can be filled by the user using a standard plunger rod and/or hypodermic needle, or other devices. A typical syringe barrel that can be used with one or more drug delivery connectors 100 is shown in Figure 1 and includes a distal end 321 and an open proximal end 329 and an end wall 322. A side wall 324 can extend. from distal end 321 to proximal open end 329 and may include an inner surface 326 that defines a chamber 328 for holding liquids. Distal end 321 of syringe barrel 300 may also include an open tip in fluid communication with chamber 328.
[048] A needle cannula (not shown) having a lumen (not shown) may be attached to the open tip 314 of the syringe barrel to aspirate or fill the syringe barrel 300 with medication. When attached to open tip 314, the lumen (not shown) is in fluid communication with open tip 314 and chamber 328 of the syringe barrel. Syringe barrel 300 may include a luer lock attachment 310 or may also include a luer slide fitting (not shown). The proximal connecting portion 170 of embodiments of the drug delivery connectors 100 described herein may include one or another mating socket for securely engaging syringe barrels having both types of luer sockets.
[049] In one or more embodiments, permanent connection mechanisms can be built into the drug delivery connector 100 such that, upon connection of the drug delivery connector 100 to the syringe barrel 300 or other container, the connection becomes becomes permanent and the drug delivery connector and syringe barrel 300 or other container are not separable. Permanent connection mechanisms can also be built into the actuator 200 so that upon connection of the actuator 200 to the catheter connector 210 or other drug delivery location, which may include a filter, the connection becomes permanent and the actuator 200 and catheter connector 210 are non-separable. The purpose of the permanent connection is to prevent disconnections between drug delivery connectors and containers or actuator and catheter connectors or other drug delivery location, leaving only the junction between drug delivery connector 100 and actuator 200 being separable. The permanent connection can be accomplished by welding, which can include ultrasonic welding, gluing, or by design by incorporating, for example, one or more ratchet connectors, special threads and other structures known in the art.
[050] Alternatively, instead of pre-assembly, the drug delivery connector 100, the actuator 200, the syringe barrel 300 and/or the catheter connector 210 can be packaged in the procedure trays or supplied as units autonomous. In such embodiments, permanent connections can be built into one or more of the drug delivery connector 100 and/or the actuator 200 by incorporating ratchet connections, threaded connections, or other known structures for connection known in the art.
[051] In one or more embodiments the drug delivery connector 100 can be attached to the syringe barrel 300 when it is empty. Upon connection of drug delivery connector 100 with syringe barrel 300, ball valve 190 forms a seal with distal wall 130 of drug delivery connector 100 as medication enters chamber 116 of drug delivery connector . In embodiments that incorporate a spring-loaded ball valve 190, the ball valve 190 forms a seal with the distal wall 130 of the drug delivery connector 100 whether or not medication enters chamber 116 of the drug delivery connector. In one or more embodiments, the presence of air within syringe barrel 300 does not necessarily close ball valve 190 and allows the user to expel any air from syringe barrel 300. The formation of the seal between ball valve 190 and the distal wall 130 prevents air and/or medication contained within the syringe barrel 300 from exiting through the hole 132 of the distal wall 130. The drug delivery connector 100 may remain unconnected or attached to an actuator 200 up to the point on the which medication contained in syringe barrel 300 is ready to be delivered or administered to a patient.
[052] To fill the syringe barrel 300, a hypodermic needle 400 can be attached to the distal end of the drug delivery connector 100 which is attached to a syringe barrel 300. As shown in Figure 17, the hypodermic needle 400 is secured to the distal connecting portion 150 of the drug delivery connector 100 using a needle hub 410. In one or more embodiments, the needle hub 410 may include an open proximal end 411, an open distal end 419, and a hub body 412 extending from the open proximal end 411 to the open distal end 419. The hypodermic needle 400 can be attached to the open distal end 419 using methods known in the art, including adhesive and the like. Hub body 412 includes an inner surface 414 defining a hub cavity 416.
[053] In one or more embodiments, the hub body 412 includes an outer surface 418. The outer surface 418 may include a projection 417 or ridge disposed adjacent the open proximal end 411 and extending outwardly from the outer surface 418 for engagement with the distal connecting portion 150. In one or more embodiments, projection 417 is shaped and/or sized to mate with threaded portion 162 disposed on inner surface 158 of coaxial wall 156 of distal connecting portion 150.
[054] In one or more embodiments, the outer surface 154 of the elongated tube 152 is tapered or has a transverse sectional width that increases from the housing sidewall 112 to the housing's open distal end 101. In one or more alternative embodiments, the outer surface 154 of the elongated tube 152 is contoured or is shaped to frictionally mate with the inner surface 414 of the hub 440. In a specific embodiment, the inner surface 414 of the hub body 412 is contoured or shaped to frictionally engage with the outer surface 154 of the elongated tube 152 of the distal connecting portion 150.
[055] After attaching the hypodermic needle 400 to the distal connecting portion 150 of the drug delivery connector, the desired amount of medication can be aspirated or transferred into the syringe barrel 300. In the embodiment shown in Figure 17, the drug barrel syringe 300, drug delivery connector 100 and hypodermic needle 400 are positioned to draw medication from a medication source, shown in Figure 17 as a vial 420. A plunger rod 320 is shown inserted into syringe barrel 300 and a force is applied to the plunger rod in the proximal direction, which draws medication into syringe barrel 300.
[056] As shown in figure 18, the force of the medication being drawn or aspirated into the syringe barrel 300 applies a force on the ball valve 190 in the proximal direction, releasing the seal between the ball valve 190 and the wall. 130 of the drug delivery connector 100. The medication enters chamber 116 of the drug delivery connector 100 and passes through the proximal connection portion 170 and into the syringe barrel. After dragging out the desired amount of medication, the hypodermic needle can be removed. Once the hypodermic needle is removed, as shown in Figure 19, the ball valve 190 closes and forms a fluid tight seal with the distal wall 130 of the drug delivery connector 100. Specifically, the medication within the syringe barrel 300 exerts a force on the ball valve in the distal direction, forcing the ball valve against the distal wall 130 or, more particularly, against the perimeter 134 of the distal wall 130. When a delivery is required, the syringe barrel assembly is required. syringe and drug delivery connector is connected to an actuator 200.
[057] In one or more embodiments, when the drug delivery connector 100 and a container, for example, syringe barrel 300, are attached, the user can remove air from syringe barrel 300 by inverting syringe barrel 300 and the drug delivery connector 100 or to position the syringe barrel 300 and the drug delivery connector 100 mounted so that the medication within the syringe barrel 300 moves, by gravity, in the proximal direction relative to the delivery connector of drug 100 and the air within syringe barrel 300 moves, by gravity, distally to the medication into chamber 116 of drug delivery connector 100. In this position, ball valve 190 will float or shift to downward toward the proximal wall 140 and the seal between the ball valve 190 and the distal wall 130 will be released. As the user applies force to the syringe plunger rod 320 in the distal direction, air trapped within chamber 116 of drug delivery connector 100 and/or syringe barrel 300 is allowed to escape through opening 142 of the proximal wall 140 and the open distal end 151 of the distal connecting portion 150. Simultaneously the medication contained within the syringe barrel 300 is forced into the chamber 116 of the drug delivery connector 100 by the force exerted on the medication by the plunger rod 320. Medication entering chamber 116 exerts a force or pressure on ball valve 190 in the distal direction, causing ball valve 190 to dislocate distally and reseal with distal wall 130 and prevent communication of fluid through hole 132 of distal wall 130. Sealed hole 132 prevents the user from directly injecting the medication contained within syringe barrel 300 into any port without the use of an actuator having a port. rma and/or specific dimensions to open the seal.
[058] To open the ball valve 190 and administer the medication contained within the syringe barrel 300, the actuator 200 is secured to the open distal end 101 of the drug delivery connector 100. The actuator 200 includes a catheter connector 210 As shown in more detail in Figures 20-21, suitable actuators 200 include an open distal end 211, a proximal end 219 and a longitudinally extending projection 212, extending in the proximal direction from the distal end 211 to the proximal end 219. The proximal end 219 of the actuator 200 is not secured to any structure and can be described as “cantilevered” or a projection 212 that is supported on only one end. The proximal end 219 of the actuator 200 can be described as a blunt tip or a rounded tip. In one or more embodiments, the proximal end 219 has an outer diameter that is larger than the inner diameter of standard luer slide fittings used on most IV medication delivery syringes to prevent accidental connection of syringes containing IV medication to the actuator. 200 and to prevent access to the anesthesia catheter.
[059] In one or more embodiments, the projection 212 has a length that allows the proximal end 219 of the actuator 200 to extend into the chamber 116 of the drug delivery connector 100, by attaching the actuator 200 to the distal connection portion 150 of the drug delivery connector 100. Projection 212 includes one or more open paths 214 extending along the length of projection 212 to allow medication within syringe barrel 300 and chamber 116 of drug delivery connector 100 to flow from the drug delivery connector 100 to a delivery location that is secured to the distal end 211 of the actuator 200. In one or more embodiments, the projection 212 is in the form of two perpendicularly crossing beams that extend in the proximal direction and define four openings. In one or more embodiments, the crossing beams can include a solid end at the proximal end 219 of the actuator 200. In one or more embodiments, the solid end is in the form of a hemisphere (not shown). In a specific embodiment, projection 212 is in the form of a single proximally extending beam (not shown) that defines two open paths 214. In a more specific embodiment, projection 212 includes a hollow member (not shown) that extends proximally. and includes a conduit (not shown) extending from open distal end 211 to open paths 214 at proximal end 219 of actuator 200.
[060] In the embodiment shown in Figures 20-21, the actuator includes a female housing or a hub 220. In one or more embodiments, the hub 220 includes an open proximal end 229, an open distal end 221, and an extending wall 222. from the proximal open end 229 to the distal open end 221 of the hub. Open distal end 211 of projection 212 is secured to open distal end of hub 220 and extends along the length of hub 220 to open proximal end 229. In one or more embodiments, wall 222 includes an outer surface 224 that includes a luer lock structure. In a specific embodiment, the luer lock structure includes at least one radially outwardly extending portion that engages with the threaded portion 162 disposed on the inner surface 158 of the coaxial wall 156 of the distal connecting portion 150 of the drug delivery connector. . In the embodiment shown in Figures 1-23, the radially outwardly extending portion includes the two radially outwardly extending tabs 227, 228. In an even more specific embodiment, the radially outwardly extending portion 226 includes a peripheral edge (not shown). In one or more embodiments, the inner surface 225 of wall 222 may have a luer slide structure. In a specific embodiment utilizing a luer sliding structure (not shown), the inner surface 225 of the wall may define a tapered transverse sectional width that increases from the distal open end 221 to the proximal open end 229 and is shaped or contoured to frictionally fit. with a standard luer sliding male fitting incorporated into alternative embodiments of a distal connecting portion 150.
[061] In the embodiment shown, the wall 222 of the hub 220 is formed in coaxial relationship with the projection 212 of the actuator and defines a cavity 216. The hub can be securely engaged with the distal end 151 of the drug delivery connector 100 by inserting the actuator 200 into the passage 155 of the elongated tube 152 of the distal connecting portion 150 of the drug delivery connector. Where hub 220 utilizes a luer lock structure, drug delivery connector 100 and/or hub 220 may be rotated relative to one another. In hub 220 embodiments utilizing a luer sliding structure (not shown), drug delivery connector 100 is inserted into cavity 216 of hub 220 until sufficient frictional interference is formed between drug delivery connector 100 and the inner surface 225 of cube 220.
[062] In the embodiment shown in Figures 20-21, the projection 212 has an axial length that allows the proximal end 219 of the actuator 200 to exert a force on the ball valve 190 in the proximal direction and cause the ball valve 190 to move in the proximal direction and release the seal between the ball valve 190 and the distal wall 130, as shown in figures 22-23. In one or more embodiments, the force exerted on ball valve 190 in the proximal direction is greater than the force exerted on ball valve 190 in the distal direction by medication within syringe barrel 300 and/or chamber 116 of the connector for drug delivery 100. In an alternative embodiment of the drug delivery connector 100 that incorporates a structure to prevent proximal movement of the ball valve 190, the force exerted on the ball valve 190 by the actuator 200 is greater than the force exerted on the valve of sphere 190 by the structures.
[063] The amount of force exerted on ball valve 190 can be adjusted to control or measure the flow rate of medication through projection 212. In one or more embodiments, projection 212 causes movement of the ball valve in the proximal direction. prior to complete attachment of hub 220 and distal connecting portion 150. In a specific embodiment, projection 212 causes proximal movement of ball valve 190 when hub 220 is fully attached to distal connecting portion 150.
[064] According to one or more embodiments, the length of the projection 212 can be adjusted to control or measure the amount of force exerted on the ball valve 190 to control or measure the flow rate of medication contained within the syringe barrel. 300 and/or chamber 116 of drug delivery connector 100. In a specific embodiment, the lengths of distal connecting portion 150 and/or hub 220 can be adjusted to control or measure the amount of force exerted on the ball valve 190 to control or measure the flow rate of medication contained within syringe barrel 300 and/or chamber 116 of drug delivery connector 100. In such embodiments, the user can control the flow rate by the amount and direction of force rotation used to engage the hub 220 and/or the distal connecting part 150. For example, if the flow rate had to be increased, the user would rotate the hub 220 and/or the distal connecting part 150 and thus the hub 220 s and would shift in the proximal direction relative to the distal connecting portion 150 and engage more of the threaded portion 162 and thus the hub 220 and/or the distal connecting portion 150 would become more fully or completely engaged. This relative proximal movement or increased engagement level between the hub 220 and the distal connecting portion 150 causes the projection 212 to apply in the proximal direction a greater force on the ball valve 190 and widen the space between the distal wall 130 and the ball valve 190. During this adjustment the force applied by projection 212 on ball valve 190 would increase relative to the fluid pressure exerted on ball valve 190 in the distal direction by the flow of medication out of syringe barrel 300. if the flow rate had to be decreased, the user would rotate the hub 220 and/or the distal connecting part 150 to rotate the hub 220 and/or the distal connecting part 150 and thus the hub 220 would move in the distal direction relative to to the distal connecting portion 150 and would engage less than the threaded portion 162 of the distal connecting portion 150, and thus the hub 220 and/or the distal connecting portion 150 would not be fully or completely engaged. This relative distal movement or decreased engagement level causes the projection 212 to apply less force in the proximal direction on the ball valve 190, thus decreasing the space between the distal wall 130 and the ball valve 190. During this adjustment the pressure of fluid exerted on ball valve 190 in the distal direction by the flow of medication from syringe cylinder 300 would increase relative to the force exerted on ball valve 190 in the distal direction by projection 212.
[065] In one or more embodiments, the actuator 200 may include a shield (not shown) extending from the distal end 221 of the hub 220 toward the proximal end 219 of the actuator 200. The shield (not shown) may be used to guide the connection between the actuator 200 and the drug delivery connector 100. In one or more embodiments, the shield (not shown) can serve as a guide to facilitate connection of the drug delivery connector to the actuator. Furthermore, the guard (not shown) can protect the actuator against side pressure, which can cause the actuator to break and/or prevent contamination of the actuator.
[066] In one or more embodiments, the shield (not shown) may be provided in the form of a peripheral wall surrounding the hub 220. The peripheral wall (not shown) may be formed to allow space between the hub and the peripheral wall for accommodate any external structures of syringe barrel 300 and syringe tip. In one or more embodiments, the peripheral wall (not shown) can have a constant cross-sectional width. In a specific embodiment, the peripheral wall (not shown) may have a tapered transverse sectional width increasing from the distal end 221 of the hub 220 to the proximal end 229 of the hub 220. The peripheral wall (not shown) may have an expanded transverse sectional width proximally adjacent to the tapered transversal sectional width. The length of the peripheral wall (not shown) may extend from the distal end 221 of the hub 220 beyond the proximal end 229 of the hub. In one or more embodiments, the length of the peripheral wall (not shown) ends at the proximal end 219 of the actuator 200. In an alternative embodiment, the length of the peripheral wall (not shown) ends at the proximal end 229 of the hub 220. In more embodiments, the peripheral wall (not shown) can be composed of a transparent material and thus the user can ensure complete connection between the hub 220 and the drug delivery connector 100. The peripheral wall (not shown) can be composed of a extruded or molded plastic material.
[067] In one or more embodiments, a catheter connector 210 is secured to actuator 200 and extends distally from distal end 211 of hub 220 and actuator 200. The one or more open paths 214 of projection 212 and the distal end open 221 of hub 220 are in fluid communication with catheter connector 210. Catheter connector 210 may include a luer lock fitting 230 or a luer slide fitting (not shown) for securing actuator 200 to devices such as catheters , a needle, e.g. a spinal needle, an epidural needle, or a hypodermic needle, and/or filters, e.g., epidural filters.
[068] In one or more embodiments, the luer lock fitting 230 of the catheter connector 210 may include an open distal end 231 and an open proximal end in fluid communication with the open distal end 221 of the hub 220 and with the distal end 211 of actuator 200. As shown in Figures 20-23, catheter connector 210 may include a tubular body 232 extending from open distal end 231 to open proximal end 239. A luer wall 234 may encircle the tubular body 232 and form a groove 236 between the tubular body 232 and the luer wall 234. The luer wall 234 may also include an inner surface 237 including a plurality of threads 238 for engaging a catheter, filter or other location of delivery.
[069] As shown in Figures 21-22, during assembly of the actuator 200 on the drug delivery connector 100 and on the syringe barrel 300, the proximal end 219 of the actuator 200 is inserted into the passage 155 of the elongated tube 152 of the part. distal connection 150 of the drug delivery connector. Projection 212 is extended through bore 132 of distal wall 130 and enters chamber 116. Continuous application of a force on actuator 200 in the proximal direction, whether or not the force includes rotational forces from hub 220 being screwed into the threaded portion 162 of the distal connection portion 150, exerts a proximally directed force on the ball valve 190 to release the seal formed between the ball valve 190 and the perimeter 134 of the distal wall 130 in the bore.
[070] In embodiments using a coil spring 192 with the ball valve 190, the actuator 200 exerts a force on the ball valve 190 in the proximal direction which compresses the coil spring 192 and displaces the ball valve 190 in a proximal direction. away from the distal wall 130. The actuator 200 applies a greater force in the proximal direction on the ball valve 190 to overcome the force exerted on the ball valve 190 by the coil spring 192. In embodiments using a retaining ring 127 on the surface internal 114 of chamber 116 of the drug delivery connector, actuator 200 applies a greater force in the proximal direction on ball valve 190 to overcome the distally directed force exerted on ball valve 190 by retaining ring 127. the seal between the ball valve 190 and the distal wall 130 is released, fluid communication between the syringe barrel 300, the drug delivery connector chamber 116 and the actuator 200 is established and Medication may be delivered from syringe barrel 300 and drug delivery connector 100 to at least one open path 214 of projection 212 of actuator 200 to the delivery port.
[071] When the drug delivery connector 100 is coupled to the syringe barrel 300 and the actuator 200, pressurized medication within the syringe barrel 300 and the drug delivery connector 100 passes around the ball valve 190 through the hole 132 and the distal connecting portion 150 of the drug delivery connector. In embodiments utilizing a plurality of ribs 122, a longitudinal protuberance 120 and/or a plurality of longitudinal protuberances 121 on the inner surface 114 of chamber 116, medication flow is facilitated by the flow paths created by ribs 122, longitudinal protuberance 120 and/ or by the plurality of longitudinal protuberances 121 which allow a greater area around the ball valve 190 through which the medication can flow.
[072] The position of the ball valve 190 uses the natural flow rate and pressure of the medication contained within the syringe barrel 300 to seal the hole 132 of the drug delivery connector 100. In other devices known in the art, the rate is Medication flow directions are used, at least partially, to open such valves. In embodiments of the present invention, actuator 200 overrides the rate and direction of flow of pressurized medication contained within syringe barrel 300 to release the seal and deliver medication to an appropriate delivery location. The modalities described in this document provide an additional safety mechanism by providing a structure that maintains the seal in the chamber 116 of the drug delivery connector inaccessible until the syringe and drug delivery connector are correctly connected to the appropriate delivery site via the actuator. Furthermore, the modalities described in this document force the user to act against natural forces and improve the steps required for connecting the syringe barrel to a delivery location such as a catheter. In addition, this configuration reduces the possibility of leakage or accidental expulsion of medication contained in the syringe barrel, prior to connection to an appropriate delivery location. Furthermore, the valve position on the drug delivery connector and/or the shape of the actuator prevents inaccurate connection or access to delivery sites, such as an anesthesia catheter, using IV medication syringes or other syringes containing other types of medication.
[073] A second aspect of the present invention concerns a method of administering epidural anesthesia to a catheter connector or other delivery site. In one or more embodiments, the method includes attaching a tip of an empty syringe barrel to an open proximal end of a drug delivery connector as described herein that includes a ball valve to seal the open distal end of the connector to drug delivery. The method further includes attaching a hypodermic needle having a cannula and an opening to the distal end of the drug delivery connector and thus the opening is in fluid communication with the syringe barrel. In one or more embodiments, the method includes drawing a quantity of an epidural anesthesia into the syringe barrel through the hypodermic needle and drug delivery connector. The flow of epidural anesthesia fluid from the hypodermic needle releases the seal between the ball valve and the open proximal end. In one or more embodiments, after a desired amount of epidural anesthesia is aspirated, the method further includes removing the hypodermic needle and attaching the distal end of the drug delivery connector to a catheter connector or other delivery site and expelling the epidural anesthesia from the syringe barrel into the catheter connector or other delivery location. After removal of the hypodermic needle and prior to connecting the drug delivery connector to the catheter connector or other delivery site, fluid flow from the syringe barrel exerts a force on the ball valve in the distal direction to cause the ball valve form a seal with the distal end to prevent fluid communication between the open distal end and the syringe barrel prior to connection to the catheter connector or other delivery location. In one or more embodiments, the method includes opening the seal formed between the ball valve and the open proximal end. In one or more embodiments, opening the seal includes applying a force to the ball valve in the distal direction. In one or more embodiments, force is applied to the ball valve in the distal direction by providing an actuator with a free proximal end extending proximally from the actuator and inserting the actuator into the open distal end of the drug delivery connector and securing the distal end of the connector for drug delivery to the actuator.
[074] In an alternative embodiment, the method of administering epidural anesthesia includes filling a syringe barrel having a tip with a predetermined amount of epidural anesthesia and attaching the syringe barrel tip to an open proximal end of a drug delivery connector , as described herein, including an open distal end and a ball valve to seal the open distal end. In a specific embodiment, the method may include removing air from within the syringe barrel and drug delivery connector after attaching the tip to the open proximal end of the drug delivery connector. In one or more embodiments, the method includes filling the drug delivery connector with epidural anesthesia to close the ball valve and seal the open distal end. In one or more embodiments, the method includes attaching a fluid communication actuator to the open distal end of the drug delivery connector. In a specific embodiment, the method includes opening the seal by applying a force proximally to the actuator to exert a proximally directed force on the ball valve to open the ball valve.
[075] Reference throughout this descriptive report to "a modality", "certain modalities" or "one or more modalities" means that a particular feature, structure, material, or characteristic described in connection with the modality is included in at least one embodiment of the invention. Thus, the meanings of phrases such as "in one or more embodiments", "in certain embodiments" or "in an embodiment" in various places throughout this specification are not necessarily referring to the same embodiment of the invention. In addition, particular features, structures, materials, or characteristics may be combined in any suitable way in one or more modalities.
[076] Although the invention herein has been described with reference to particular embodiments, it is to be understood that these embodiments are only illustrative of the principles and applications of the present invention. It will be apparent to those skilled in the art that various modifications and variations can be made to the method and apparatus of the present invention without departing from the spirit and scope of the invention. Thus, it is considered that the present invention includes modifications and variations that are within the scope of the appended claims and their equivalences.

权利要求:
Claims (10)
[0001]
1. A drug delivery connector, comprising: a housing (110) including an open distal end (101), an open proximal end (109), a distal connecting portion (150), a proximal connecting portion (170) for securing the housing (110) to a container, and a chamber (116) including a distal wall (130) disposed between the chamber (116) and the distal connecting portion (150) that is in fluid communication with the open distal end. (101) and with the proximal end open (109), CHARACTERIZED by a ball valve (190) disposed within the chamber so that the ball valve (190) floats within the chamber (116), wherein the ball valve (190) which is movable in a distal direction to form a releasable seal with the distal wall (130) to prevent fluid flow from the open proximal end (109) to the open distal end (101) by applying force in the distal direction. in the ball valve applied by a fluid by the attachment of a container containing fluid to the proximal connecting portion, and wherein the ball valve (190) is movable in a proximal direction to release the releasable seal to allow fluid flow from the open proximal end (109) to the open distal end (101) ; and an actuator (200) for securing the open distal end of the housing, the actuator comprising a projection (212) extending in the proximal direction and including at least one opening in fluid communication with the open distal end of the actuator and the open distal end of the housing, wherein by attaching the actuator (200) to the open distal end (101) of the housing, the projection (212) applies a force on the ball valve (190) in the proximal direction to move the ball valve (190) in the direction. proximal.
[0002]
A drug delivery connector according to claim 1, CHARACTERIZED in that the housing (110) comprises a proximal wall disposed adjacent the open proximal end (109), the proximal wall (140) including at least one opening allowing constant fluid communication between the open proximal end (109) and the chamber (116).
[0003]
3. The drug delivery connector according to claim 1, CHARACTERIZED in that the housing (110) comprises a distal wall disposed adjacent the open distal end (101), the distal wall including a hole (132) having a perimeter (134), the perimeter (134) configured to contact the ball valve (190) to form a releasable seal between the ball valve (190) and the distal wall.
[0004]
4. Connector for drug delivery according to claim 1, CHARACTERIZED in that the housing (110) comprises a structure for forming one or more fluid flow paths around the ball valve (190) selected from a or more of a longitudinal protuberance (121), a rib, an expanding sidewall, and combinations thereof.
[0005]
5. Connector for drug delivery, according to claim 1, CHARACTERIZED by the fact that the distal connection part comprises one of a luer lock fitting or a luer slip fitting.
[0006]
6. Connector for drug delivery, according to claim 1, CHARACTERIZED by the fact that the proximal connection part comprises one of a luer lock fitting or a luer slip fitting.
[0007]
7. Connector for drug delivery, according to claim 1, CHARACTERIZED by the fact that the chamber (116) of the housing (110) comprises a retaining ring (127) that inhibits movement of the ball valve (190) in the direction proximal.
[0008]
A method of delivering liquid medication to a catheter connector, comprising: providing a drug delivery connector as defined in any one of the preceding claims; attach the actuator to the catheter connector; attaching a tip (314) of a syringe barrel (300) to the open proximal end (109) of the drug delivery connector; filling the syringe barrel (300) with a predetermined amount of liquid medication; filling the chamber (116) of the drug delivery connector with the liquid medication so that the liquid medication applies a force distally to the ball valve to form the seal between the ball valve (190) and the distal wall ( 130); and releasing the seal between the ball valve (190) and the distal wall (130) by attaching the open distal end (101) to the actuator (200), wherein the projection (212) has a length that extends into the chamber (116) and an open path in fluid communication with the catheter connector such that the projection applies a force in a direction proximal to the ball valve.
[0009]
9. Method according to claim 8, CHARACTERIZED by the fact that the actuator projection extends into the chamber and creates an open path in fluid communication with the catheter connector.
[0010]
10. Method according to claim 9, CHARACTERIZED by the fact that the release of the seal allows liquid medication to flow from the chamber (116) to the open path.

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同族专利:

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公开号 | 公开日

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US9205248B2|2015-12-08|

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JP5632491B2|2014-11-26|

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CA2790723A1|2011-09-01|

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US20110208128A1|2011-08-25|

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CA2790723C|2018-03-27|

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CN102844073A|2012-12-26|

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MX2012009779A|2012-09-12|

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AU2011220863B2|2015-10-08|

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US9381339B2|2016-07-05|

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CN102844073B|2015-11-25|

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BR112012021414A2|2020-08-25|

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EP2539014A1|2013-01-02|

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ES2587758T3|2016-10-26|

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JP2013520287A|2013-06-06|

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WO2011106374A1|2011-09-01|

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USD892277S1|2018-12-21|2020-08-04|Green Co2 Ip, Llc|Fill gun socket|

法律状态:
2020-09-08| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|

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2020-09-15| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|

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2021-03-16| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|

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2021-04-20| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 23/02/2011, OBSERVADAS AS CONDICOES LEGAIS. PATENTE CONCEDIDA CONFORME MEDIDA CAUTELAR DE 07/04/2021 - ADI 5.529/DF |

优先权:

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申请号 | 申请日 | 专利标题

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US12/711,641|US9205248B2|2010-02-24|2010-02-24|Safety Drug delivery connectors|

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US12/711,641|2010-02-24|

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PCT/US2011/025858|WO2011106374A1|2010-02-24|2011-02-23|Safety drug delivery connectors|

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