WO2007027567A1

WO2007027567A1 - Medical fluid container system having needle-free connection

Info

Publication number: WO2007027567A1
Application number: PCT/US2006/033441
Authority: WO
Inventors: Frank Fago
Original assignee: Mallinckrodt Inc.
Priority date: 2005-08-29
Filing date: 2006-08-28
Publication date: 2007-03-08

Abstract

The present invention is directed to systems and methods for medical fluid containment that allow for the transfer of fluid between a container and a medical device without employing a needle (e.g., hollow, hypodermic needle). An exemplary container of the invention includes a cover assembly that may include a number of components, such as a valve, a cap, and an actuator. In use, a medical device may be inserted into a flow passage defined in the cap of the cover assembly. This insertion of the medical device may cause the actuator disposed in the flow passage to move relative to the cap. Due to this movement of the actuator, the valve of the cover assembly may be moved thereby relieving an occlusion of the flow passage and allowing fluid transfer between the medical device and the container.

Description

MEDICAL FLUID CONTAINER SYSTEM HAVING NEEDLE-FREE CONNECTION

BACKGROUND

[0001] This invention relates generally to medical fluid containers and, more particularly, to a cover assembly for a medical fluid container that allows for the transfer of fluid between the medical fluid container and a medical device (e.g., syringe) without the use of a needle.

[0002] In many medical procedures, medical fluid (e.g., contrast media for diagnostic imaging, drugs, parenteral fluid, enteral fluid, etc.) is transferred from a medical fluid container (e.g., a bottle or vial) to a medical device (e.g., syringe, i.v. bag, enteral feeding set, etc.) for delivery to a patient. Typically, the caps of these medical fluid containers include an elastomeric septum. The fluid in the container may be transferred to a syringe by piercing the septum with a needle of the syringe body and actuating a plunger of the syringe to draw fluid from the container through the needle and into the syringe. The use of needles to draw medical fluid from a medical fluid container into a medical device such as a syringe may tend to increase a likelihood of inadvertent needle sticks for healthcare technicians.

[0003] Needle-stick prevention regulations require healthcare providers to reduce non-essential use of hypodermic needles in an effort to reduce occurrences of inadvertent needle sticks. Cover assemblies for medical containers exist that allow fluid to be transferred from the container to the syringe without the use of a needle. However, many of these cover assemblies tend to be complex and/or expensive to manufacture.

SUMMARY

[0004] Accordingly, the present invention is directed to systems and methods for containment of medical fluid that allow such fluid to be transferred between a container (e.g., vial, bottle, or the like) and a medical device (e.g., syringe) without employing a hollow needle (e.g., hypodermic needle) to assist in the transfer. For example, in some embodiments of the invention, a nozzle of a syringe may be directly inserted into an access port of a medical fluid container to open a valve of the container and allow fluid transfer between the syringe and the container.

[0005] One aspect of the present invention is directed to a medical fluid container system that includes a container and a cover assembly attached to the container. This cover assembly allows fluid to be transferred between the container and the medical device without the use of a needle. The cover assembly includes a valve, a cap, and an actuator. The valve of the cover assembly has at least one aperture defined in it and includes a valve member that may be used to control the transfer of fluid between the container and the medical device. The cap of the cover assembly has a flow passage having first and second ends defined in it. A seat of the cover assembly is disposed at a first end of the flow passage and is in contact with the valve member when the valve is in a closed position. An opening found at the second end of the flow passage is designed to receive the medical device. The actuator of the cover assembly is designed to move the valve from the closed position to an open position allowing flow between the container and the medical device.

[0006] Another aspect of the present invention is also directed to a medical fluid container system that includes a container and a cover assembly attached to the container. However, in this second aspect, the cover assembly includes what are referred to as first, second, and third components. The first component of the cover assembly is substantially rigid and has a fluid flow passage defined in it. The second component of the cover assembly is in contact with the first component and has at least one aperture defined in it. Further, at least a portion of this second component is substantially flexible. The third component of the cover assembly is substantially rigid and is in contact with the first and second components. At least a portion of this third component is disposed in the fluid flow passage that is defined in the first component.

[0007] In yet another aspect, the invention is directed to a method of transferring fluid between a medical device and a medical fluid container having a cover assembly. The medical device is inserted into a fluid flow passage defined in the cover assembly. This insertion of the syringe into the fluid flow passage tends to cause a first component (e.g., an actuator) of the cover assembly to move from a first position to a second position. A second component (e.g., valve) of the cover assembly is stretched due to the movement of the first component. This stretching of the second component tends to relieve an occlusion of the fluid flow passage, thus allowing fluid to flow therethrough.

[0008] Various refinements exist of the features noted in relation to the above-mentioned aspects of the present invention. Further features may also be incorporated in the above-mentioned aspects of the present invention as well. These refinements and additional features may exist individually or in any combination. For instance, various features discussed below in relation to any of the illustrated embodiments of the present invention may be incorporated into any of the above-described aspects of the present invention, alone or in any combination.

BRIEF DESCRIPTION OF THE FIGURES

[0009] Fig. 1 is a cross-section of a medical fluid container having a cover assembly;

[0010] Fig. 2 is a cross-section of the medical fluid container of Fig.l showing a valve of the cover assembly in an open position to allow fluid flow between the container and a medical device;

[0011] Fig. 3 is an exploded perspective view of the cover assembly removed from the medical fluid container; and [0012] Fig. 4 is an exploded partial section of the cover assembly removed from the medical fluid container.

DETAILED DESCRIPTION QF THE ILLUSTRATED EMBODIMENTS

[0013] Referring now to the figures and in particular to Figs. 1-3, a medical fluid container 1 may be used to store medical fluid F (e.g., diagnostic imaging contrast media, drugs, parenteral fluid, enteral fluid, etc.) until transferred to a medical device S (Fig. 2) that may be used to deliver the fluid to a patient. In the illustrated embodiment, the medical device is a syringe having a nozzle N with a male luer fitting M and a blunt end B that is free of a needle or other sharp penetrating member. But it is understood that the medical device S could be other types of fluid receiving devices (e.g., i.v. bag, enteral feeding set, etc.) that do not use a needle or other piercing structure. Incidentally, one or both of the medical fluid container 1 and the medical device S may be sterilized. The medical fluid container 1 has a closed base 5, a tapered neck portion 7, an opening 9, and a flange 11 surrounding the opening. It should be noted that the figures illustrate one exemplary embodiment of the container 1, and that other embodiments may exhibit other appropriate designs, shapes and/or sizes of the container 1.

[0014] Still referring to Figs. 1-3, the container 1 includes a cover assembly 15 that may be partially received in the opening 9 of the container for sealing the container and allowing fluid F to be transferred between the container and the medical device S without the use of a needle (not shown). The cover assembly 15 includes a cap 17 that fits on the flange 11 of the container 1 and a valve 21 that is moveable between a closed position (Fig. 1), in which flow of medical fluid F through the cover assembly 15 is substantially prevented, and an open position (Fig. 2), in which the flow of medical fluid through the cover assembly 15 is permitted. At least a portion of an actuator 25 of the cover assembly 15 may be disposed in the cap 17 to actuate the valve 21.

[0015] In the illustrated embodiment, the cap 17 of the cover assembly 15 is shaped to engage the flange 11 of the medical fluid container 1 to hold the cover assembly 15 in the opening 9 of the container. As shown, the cap 17 defines what may be characterized as the outermost portion of the cover assembly 15. The cap 17 has a substantially cylindrical outer wall 29 with a bent edge 31 that engages the flange 11 surrounding the opening 9 of the container 1. Thus, the cover assembly 15 may be attached to the container by a snap-fit engagement of the cap with the flange. The cap 17 has a substantially cylindrical inner wall 33 and an annular wall 35 that, in combination with the outer wall 29, form an annular channel 37 for accommodating the flange 11 and the valve 21. In addition, the cap 17 includes a substantially cylindrical conduit 39 aligned with a central axis Al (Fig. 3) of the cover assembly 15 that defines a flow passage 41 for the flow of fluid F from and/or to the container 1. In some embodiments, the cap 17 may include a conical wall 45 between the inner wall 33 and the conduit 39. This conical wall 45 may tend to taper toward the base 5 of the container 1. The flow passage 41 includes a substantially cylindrical upper portion 49 with an open upper end that forms a seat 51 at a junction between the conduit 39 and the conical wall 45 for contact with the valve 21 when the valve is in the closed position (Fig. 1). As shown in Fig. 1, the flow passage 41 has a female luer fitting portion 53 (broadly, "opening") and a flange 57 at a lower end for mating with the male luer fitting M (Fig. 2) of the syringe S. The cap 17 may be made from a rigid material (e.g., plastic or other suitable material) to protect one or more portions of cover assembly 15 and/or assist in holding the valve 21 between the cap and the flange 11 of the medical fluid container 1. Incidentally, while the cover assembly 15 has been described above as being attachable to the container by a snap-fit engagement of the cap with the flange, other embodiments of the invention may include other appropriate manners of attaching a cover assembly to a container including, but not limited to, threading engagements, friction fittings, crimping, and adhesion.

[0016] The valve 21 of the cover assembly 15 extends across the opening 9 of the container 1 and at least assists in controlling the flow of medical fluid F through the flow passage 41. The valve 21 has an outer surface 63 at least generally facing the cap 17 and an opposing inner surface 65 at least generally facing the base 5 of the container 1. In the illustrated embodiment, the valve 21 has a substantially conical section 69 that extends inward away from the cap 17 and spans across the opening 9 of the container 1, a flange 73 disposed in the annular channel 37 of the cap, and a substantially cylindrical side wall 75 between the flange and the substantially conical section 69. As shown in Fig. 3, the valve 21 (including the flange 57, the side wall 75, and the substantially conical section 69) may be formed as one piece. Alternatively, the valve 21 may be constructed of two or more pieces attached or held together by various appropriate attachment techniques (e.g., ultrasonic welding). In some embodiments, at least a portion (e.g., a substantial entirety) of the valve 21 is made of one or more resilient materials such as natural rubber (e.g., latex rubber, dry natural rubber, and/or any other suitable natural rubber), synthetic rubber (e.g., neoprene, EPDM rubber, Buna-N (Nitrile), VITON rubber, etc.) and other suitable elastomeric polymers.

[0017] As shown in Figs. 1-2, the substantially conical section 69 of the valve 21 has a valve member 79 on the outer surface 63 of the valve 21 that may be characterized as an at least partially spherical protrusion axially aligned with the flow passage 41 in the cap 17. The valve member 79 contacts the seat 51 in the cap 17 when the valve 21 is in the closed position (Fig. 1). This valve member 79 may be said to act as an occlusion that blocks the flow of fluid F through the flow passage when the valve 21 is in the closed position. The valve member 79 extends outward from the outer surface 63 of the valve 21 toward the cap 17. It is understood that the valve member 79 may have other shapes besides at least partially spherical without departing from the scope of the invention. For example, the valve member 79 may include a protrusion with grooves or notches (not shown) to facilitate the flow of medical fluid F into the flow passage 41 of the cap 17 when the protrusion is separated (e.g., lifted) from the seat 51.

[0018] In the open position of the valve 21 (Fig. 2), the valve member 79 is spaced apart from the seat 51 to allow fluid F to flow through the flow passage 41 of the cap 17. In the illustrated embodiment, the substantially conical section 69 of the valve 21 has five apertures 83 defined therein passing from the outer surface 63 to the inner surface 65. While not always the case, these apertures 83 are shown as being substantially equally spaced apart on the valve 21. Further, while the valve 21 is shown as having five apertures, other embodiments of the valve may have less than five apertures 83 (e.g., at least one) or more than five apertures without departing from the scope of this invention. When the valve 21 of some embodiments is in the open position, the valve 21 may be said to allow the medical fluid F to pass from the medical fluid container 1 through the apertures 83 of the valve 21 and into the flow passage 41 of the cap 17. Additionally or alternatively, when the valve 21 of some embodiments is in the open position, the valve 21 may be said to allow the medical fluid F to pass from the flow passage 41 of the cap 17 through the apertures 83 of the valve 21 and into the medical fluid container 1. Simply put, the valve 21 of the cover assembly 15 may allow for medical fluid to be selectively removed from and/or placed into the container 1.

[0019] As shown in Figs. 1 and 2, the actuator 25 of this embodiment is disposed in the flow passage 41 in a manner that allows it to move at least generally bidirectionally along the central axis Al relative to the cap 17. This capacity for movement of the actuator 25 allows for selective actuation of the valve 21 by moving the valve (via movement of the actuator) between the open and closed positions as desired. The actuator 25 has a first end 93 for contact with the valve 21 and a second end 95 for contact with the medical device S. As shown in Fig. 3, the actuator 25 may include four fins 99 extending radially from a central axis of the actuator that is generally aligned with the central axis Al of the cover assembly 15. Each fin 99 may be oriented approximately 90 degrees relative to an adjacent fin to form a respective space 101 between adjacent fins. In some embodiments, the fins 99 are oriented so that the actuator 25 has a cross-sectional shape in the form of a plus sign. The actuator 25 may be axially aligned in the flow passage 41 such that the first end 93 of the actuator contacts the valve member 21 when the actuator is urged upward in the flow passage by contact with the medical device S at the second end 95 of the actuator. When the actuator 25 has been moved toward the base 5 of the container a distance sufficient to separate the protrusion 79 from the seat 51, the fluid F is allowed to flow along a flow path indicated by arrows A2 (Fig. 2) through the apertures 83, past the protrusion, into the spaces 101 between the fins 99 in the flow passage 41, and into the medical device S. The assembly 15 may include an actuator retainer feature to at least assist in keeping the actuator 25 in the flow passage 41. For example, Fig. 4 shows that the assembly 15 may include a shoulder 103 along the flow passage 41. [0020] If one desires to place fluid F from the medical device S into the container 1, the nozzle N of the medical device S may be inserted into the flow passage 41 of the cap 17 to move the actuator 25 toward the base 5 of the container, thus separating the protrusion 79 of the valve 21 from the seat 51. The fluid F may be ejected out of the medical device S so that the fluid flows through the flow passage 41, around the fins 99 of the actuator 25, past the protrusion 79 of the valve 21, through the apertures 83 in the valve, and into the container 1. In other words, to place fluid into the container 1, the fluid F would flow from the medical device S into the container 1 in a flow path substantially opposite of that indicated by arrows A2 (Fig. 2).

[0021] In the illustrated embodiment, the actuator 25 is made of a material such as plastic having a coefficient of friction that allows the actuator to move (e.g., axially slide) in the flow passage 41 in response to a biasing force imposed through a biasing of the medical device S or a downward contact force from the protrusion 79. Also, the illustrated actuator 25 is sufficiently rigid to press against the resilient valve member 79 to apply an actuating force that can separate the valve member from the seat 51 and stretches the valve 21 to the open position. It is understood that the actuator 25 could be made any number of appropriate materials and may exhibit other shapes and/or designs without departing from the scope of this invention. For example, the actuator 25 could be a cylindrical tube (not shown) having radial openings at or near its upper edge to allow medical fluid F to flow into the flow passage 41 when the valve member 21 is separated from the seat 51. Incidentally, both ends of the illustrated actuator 25 are blunt or dull. As such, the illustrated actuator 25 cannot penetrate (e.g., pierce or cut through) other portions of the assembly (e.g., the valve 21, the cap 17, or the medical device S).

[0022] In operation, the illustrated cover assembly 15 may be used to transfer medical fluid F between the container 1 and the medical device S without the use of a needle attached to the medical device. As shown in Fig. 2, the blunt end B of the nozzle N of the medical device S is inserted into the flow passage 41 in the cap so that the nozzle contacts the actuator 25. The nozzle N is further inserted into the flow passage 41 so that the male luer fitting M seals against the female luer portion 53 of the flow passage 41, and the actuator 25 is axially moved in the flow passage pressing against the valve member 79 and thereby causing the valve 21 to stretch or deform. As the valve 21 stretches, the valve member 79 dissociates from the seat 51 thereby relieving the occlusion from the flow passage. A plunger or other actuator (not shown) on the medical device S may be actuated to withdraw fluid F from the medical fluid container 1 along the flow path indicated by arrows A2 (Fig. 2). In operation, no portion of the illustrated assembly 15, including the actuator 25, extends through the valve 21 or the apertures 83 therein. The fluid F flows through the apertures 83 in the valve 21, into the spaces 101 between the fins 99 in the flow passage 41, and into the medical device S. When a desired amount of fluid F has been withdrawn from the medical fluid container 1, the medical device S may be removed from the flow passage 41 and the resilient valve 21 is thus allowed to return to the closed position (e.g., via retraction of the valve material). As the valve 21 returns to the closed position, the resilient valve member 79 contacts the actuator 25 and applies a force to the actuator that forces the actuator downward (as viewed in Figs. 1 and 2) in the flow passage 41 to a position wherein the valve member contacts the seat 51 occluding flow of medical fluid F through the cap 17. Because the valve 21 includes a resilient material, the substantially conical section 69 and the cylindrical portion 75 of the valve can stretch to the open position of the valve when an appropriate biasing force is applied to the valve by the actuator 25. In the closed position, or relaxed state of the valve 21, with the medical device S withdrawn from the conduit 39, the valve 21 contracts and applies a biasing force against the actuator 25 to bias the valve member 79 to the closed position to prevent leakage of medical fluid F from the container 1.

[0023] When introducing elements of various aspects of the present invention or illustrated embodiment(s) thereof, the articles "a", "an", "the" and "said" are intended to mean that there are one or more of the elements. The terms "comprising", "including" and "having" are intended to be inclusive and mean that there may be additional elements other than the listed elements. Moreover, the use of "top" and "bottom", "front" and "rear", "above" and "below" and variations of these and other terms of orientation is made for convenience, but does not require any particular orientation of the components.

[0024] As various changes could be made in the above constructions without departing from the scope of the invention, it is intended that all matter contained in the above description or shown in the accompanying figures shall be interpreted as illustrative and not in a limiting sense. Further, all dimensional information set forth herein is exemplary and is not intended to limit the scope of the invention.

Claims

CLAIMSWhat is claimed is:

1. A medical fluid container system comprising: a container; and a cover assembly at least partially received in the container and comprising: a valve having at least one aperture therethrough and a valve member for controlling the transfer of fluid between the container and a medical device; a cap having a flow passage therethrough, a seat at a first end of the flow passage in contact with the valve member at a closed position of the valve, and an opening at a second end of the flow passage for receiving the medical device; and an actuator for actuating the valve to move the valve from the closed position preventing flow between the container and the medical device and an open position allowing flow between the container and the medical device.

2. The system of claim 1 wherein the valve is resilient and has an outer surface and an inner surface.

3. The system of claim 2 wherein the valve member comprises a partially spherical protrusion on the outer surface of the valve.

4. The system of claim 3 wherein the valve has a conical section extending inward away from the cap, the protrusion extending outward from the outer surface and toward the cap.

5. The system of claim 4 wherein the valve comprises a flange, at least a portion of the flange being disposed between the container and the cap, and a generally cylindrical side wall between the flange and the conical section.

6. The system of claim 5 wherein the conical section, the valve member, the flange, and the side wall of the valve are formed as one piece.

7. The system of claim 1 wherein the medical device is a needle-free syringe having a luer fitting, the opening being shaped to receive the luer fitting.

8. The system of claim 1 wherein the valve comprises a flange for connection to the medical container and a generally cylindrical side wall between the flange and the conical section.

9. The system of claim 8 wherein the actuator has a first end for contact with the valve and a second end for contact with the medical device, the actuator being movable in the flow passage.

10. The system of claim 1 wherein the actuator has at least two fins oriented approximately 90 degrees relative to each other and a space between the at least two fins for the flow of fluid therethrough.

11. The system of claim 10 wherein the actuator has four fins.

12. A medical fluid container system comprising: a container; and a cover assembly attached to the container, the cover assembly comprising: a substantially rigid first component having a fluid flow passage defined therein; a second component in contact with the first component and having at least one aperture defined therein, wherein at least a portion of the second component is substantially flexible; and a substantially rigid third component, at least a portion of which is disposed in the fluid flow passage, wherein the third component is in contact with the first component and the second component.

13. The system of claim 12 wherein the second component comprises an at least partially spherical protrusion that occludes the fluid flow passage.

14. The system of claim 12 wherein at least a portion of the fluid flow passage is substantially tapered.

15. The system of claim 12 further comprising an imaginary reference axis that extends through the fluid flow passage, wherein the third component is movable along the reference axis.

16. The system of claim 12 wherein at least a portion of the second component is disposed between the container and the first component.

17. The system of claim 12 further comprising a syringe, wherein at least a portion of a nozzle of the syringe is disposable in the fluid flow passage defined in the first component of the cover assembly.

18. The system of claim 17 wherein a first end of the third component is in contact with the second component, and a second end of the third component is contacted by the syringe when the nozzle is disposed in the fluid flow passage.

19. The system of claim 12 wherein the third component is designed to allow fluid to flow therethrough and/or thereabout.

20. The system of claim 12 wherein the at least one aperture defined in the second component does not overlap with the fluid flow passage defined in the first component.

21. A method of transferring fluid between a medical device and a medical fluid container, the method comprising: inserting the medical device into a fluid flow passage defined in the cover assembly, wherein the inserting comprises moving a first component of the cover assembly from a first position to a second position; and stretching a second component of the cover assembly due to the moving of the first component, wherein the stretching comprises relieving an occlusion of the fluid flow passage of the cover assembly.

22. The method of claim 21 wherein the inserting comprises inserting a nozzle of a syringe into the fluid flow passage and contacting the first component with the nozzle.

23. The method of claim 22 wherein the stretching comprises axially moving the first component.

24. The method of claim 21 further comprising removing the medical device from the fluid flow passage, wherein the removing comprises the first component of the cover assembly moving from the second position to the first position, and wherein the removing comprises the second component occluding the fluid flow passage.