WO1993003702A1

WO1993003702A1 - Injection site protective cap

Info

Publication number: WO1993003702A1
Application number: PCT/US1992/006909
Authority: WO
Inventors: Thomas A. Stonis; Jeffrey Packard; Michael Finley; Richard A. Rollins
Original assignee: Baxter International Inc.
Priority date: 1991-08-19
Filing date: 1992-08-17
Publication date: 1993-03-04
Also published as: CA2094152A1; EP0553341A1

Abstract

A cap (34) for providing a tamper evident cover for sealing a portion of an additive port (14), including an injection site (22), of a container (10). The cap (34) comprising first and second halves (36, 38) hinged together along a first edge (40, 42) of each allowing portions of the halves to move towards and away from each other. An interior (50, 52) is defined by the halves for receiving at least a portion of the port (14) and the injection site (22). Members (54, 56) are provided for securing a second edge of the first half to a second edge of the second half. At least one of the first or second halves (36, 38) includes a member (57) circumscribing an interior thereof for causing at least the injection member to be removed upon the application of a sufficient pulling force when the cap is secured to the additive port.

Description

S P E C I F I C A T I O N

TITLE

INJECTION SITE PROTECTIVE CAP

BACKGROUND OF THE INVENTION The present invention relates generally to tamper evident and tamper resistant devices. More specifically, the present invention relates to protective caps for solution container injection sites.

It is known in the medical industry to package a medical solution, such as parenteral, peritoneal, and enteral solutions, in containers. An example of such a container is a flexible container manufactured by Baxter Healthcare Corporation, Deerfield, Illinois, under the trademark VIAFLEX^®. The solutions housed in these containers are typically accessed, so that the solution can be administered to a patient, by use of a port extending from the container. As used herein, the term "port(s)" includes, without limitation, fitments, valves, or other means for accessing a container. The port is accessed usually with a needle or spike allowing the removal of the contents of the container.

Typically, the port comprises a tubular structure with an inner bore that extends from a base. Located within the inner bore is a pierceable wall that provides a barrier between the fluid contained within the container and the outside environment. Usually, a needle, spike, or other pointed means that pierces the pierceable wall is used to gain access to the fluid and thereby the container.

Preferably, these containers include at least a pair of tubular sterile access ports. The second port is provided, principally, for the purpose of allowing supplemental medication or an additive to be added to the solution housed in the container, by means, for example, of a hypodermic needle; hence, its name additive port or injection port. In this regard, the additive ports typically include a latex, needle pierceable stopper located at an end of the additive port. The needle, pierceable stopper is so constructed and arranged that it reseals the port after the needle has been inserted through the port and withdrawn from same allowing an additive or supplemental medicament to be added to the container.

Due to the resealable nature of the injection site, it may be difficult, if not impossible, to determine if the necessary additive has been added to the container. Unfortunately, excess amounts of an additive can have severe adverse consequences on a patient. It is therefore essential that medical personnel can determine whether the requisite additive has been added to the solution container. A number of methods have been proposed to provide a method for determining if an additive port has been accessed. To this end, tamper evident port closures have been used. Additionally, supplemental additive indication caps have been provided to afford a method for alerting medical personnel that an additive has been added to the solution container.

For example, U.S. Patent No. 4,005,739 discloses a supplemental medication indication cap for solution containers having a tubular access port. A tubular member, adapted to fit about the tubular access port de: ines one end thereof which carries a member for irreversibly engaging the access port. Typically, the member comprises a plurality of barbed gripper arms. The gripper arms engage the tubular access port in such a manner as to prevent the nondestructive removal of the cap, once it is installed on the access port.

U.S. Patent No. 4,068,696 discloses a supplemental medication indication cap for solution containers having a tubular access port. A tubular member, adapted to fit about the tubular access port, defines one end thereof which carries a member for irreversibly engaging the access port. Typically, the member comprises a plurality of barbed gripper arms. The gripper arms engage the tubular access port in such a manner as to prevent the nondestructive removal of the cap once it is installed on the access port. The cap also carries an auxiliary sleeve that is positioned about the barbed gripper arms. The sleeve prevents those who would tamper with the • indicating cap from being able to open the gripper arms, and thus, remove the cap after its installation on a tubular access port.

SUMMARY OF THE INVENTION The present invention provides a cap for an injection site that acts as a tamper evident device and is also tamper resistant. The cap affords the advantage of being easy to apply to an injection site. Additionally, the cap provides the advantage of an improved tamper evident device by providing evidence of tamper to the container rather than to the cap.

To this end, in an embodiment, a cap for sealing an additive port, including an injection site, of a container is provided comprising two halves that are hinged together along one edge. The hinge member allows an opposite edge of each of the halves to move toward the other half. Means are provided for securing the opposite edges of the first and second half together about an injection site. The first and second halves define an interior for receiving at least a portion of the additive port and the injection site. Means are provided for preventing the removal of the cap without removing at least the injection site from the container.

In an embodiment, the interior defined by the first part and second part includes a collar circumscribing at least a portion of the interior thereof. Preferably, the collar includes a plurality of teeth. In an embodiment, the cap includes a top portion so constructed and arranged as to prevent a cannula from piercing the injection site when the cap is secured to the additive port.

In an embodiment, the first half includes apertures and the second half includes locking members to be received within the apertures. Preferably, the locking members are hooks extending from the second half.

In an embodiment, the locking members and apertures for securing the cap around the injection site are locking members and apertures located within an interior of the cap when the cap is secured around the additive port.

Additional features and advantages of the present invention are described in, and will be apparent from, the detailed description of the presently preferred embodiments and from the drawings.

BRIEF DESCRIPTION OF THE DRAWINGS Figure 1 illustrates a perspective view of an embodiment of the cap of the present invention, a portion of which has received a part of the additive port of a container.

Figure 2 illustrates a top elevational view of the cap of Figure 1. Figure 3 illustrates a perspective view of another embodiment of the cap.

Figure 4 illustrates a side elevational view of the cap of Figure 3. Figure 5 illustrates a further embodiment of the cap of the present invention.

Figure 6 illustrates a side elevational view of the cap of Figure 5.

DETAILED DESCRIPTION OF THE PRESENTLY PREFERRED EMBODIMENTS

The present invention provides a protective cap to be secured over at least the injection site of an additive port of a container. The device functions as a tamper evident member that is also tamper resistant. The cap is easily located over the additive port and is closed using locking snaps that cannot be reopened without easily observable damage to the snaps. Due to collars located within the interior of the cap, if a sufficient force is applied to remove the cap, at least the injection site of the additive port will also be removed.

Referring now to the Figures, a portion of a sterile solution container 10 constructed from flexible plastic material is illustrated. The container 10 can be any container known in the art. However, the invention is particularly directed to use with a container for housing medical solutions. An example of such a solution container is the VIAFLEX^® container sold by Baxter Healthcare Corporation of Deerfield, Illinois. The container 10 typically includes at least a pair of flexible plastic tubular ports, an access port (not illustrated) and an additive port 14. The ports are similar in that they include an outer wall that defines a tubular bore that terminates in an opening.

To this end, the additive port 14 comprises a tubular member 16 that terminates in an opening 18. A partition wall (not illustrated) divides the tubular bore 14 into an upper portion 20 and a lower portion (not shown) . The port 14 is typically inverted when the container 10 is hung to dispense fluid, and the partition wall functions to prevent the fluid from long term contact with a closure that may be secured around an end of the port. Furthermore, the partition wall prevents fluid flow until the container is accessed.

The upper portion 20 includes a resealable injection site 22. The resealable injection site 22 provides means for resealing the additive port 14 after a needle or syringe is removed from the injection site. Accordingly, an additive or medicament can be added to the container 10 and the container can still be used to house, in a sterile manner, the solution contained therein. As illustrated, typically, the resealable member 22 includes a top portion 26 with an extended portion 28 that is received with the tubular member 16. A skirt 30 is provided that extends around an outer portion 31 of the tubular member 16. Preferably, a shrink wrap 32 is used to secure the resealable member 22 to the port 14. Referring now to Figures 1 and 2, an embodiment of the cap 34 for providing a tamper evident and tamper resistant cap for an additive port 14 is illustrated. The cap 34 includes a first and a second half 36 and 38 respectively. The first and second half 36 and 38 are hinged together along one edge thereof, 40 and 42, respectively, by a hinge 44. The hinge 44 allows opposite ends 46 and 48 of the first and second half 36 - 1 -

and 38 to be moved toward and away from each other. As discussed in more detail below, this allows the cap 34 to be snapped around an additive port 14.

In the embodiment of the cap illustrated in Figures 1 and 2, each of the first and second halves 36 and 38 define an interior portion 50 and 52, respectively. The interior portions 50 and 52 of each of the first and second halves 36 and 38 cooperate to define an interior for receiving at least the injection site portion 22 of the additive port 14.

In the embodiment, illustrated, additionally, each of the interior members 50 and 52 includes a collar 54 and 56, respectively, that circumscribes the interior portion. Preferably, the collars 54 and 56 include a plurality of teeth 57.

The collars 54 and 56 are so constructed and arranged that when the additive port 14 is received within the interiors 50 and 52 and the two halves 36 and 38 are snapped together, the collarsare located below an end 53 of the injection site 22. When so located, the teeth 57 grip the port 14 on the underside of the injection site 22 preventing the removal of the cap 34 from the port 14 without also the removal of at least the injection site. If desired, only one half 36 or 38 of the cap 34 can include a collar on an interior thereof.

Each of the first and second halves 36 and 38 also includes a wall 58 and 60, respectively, having a sufficient thickness to prevent the insertion of a syringe through the cap 34 and into the injection site 22 when the cap 34 is secured around the injection site. This therefore prevents further reinjectionε of the container 10 once the cap 34 has been placed and locked closed over the additive port 14 as illustrated in Figure 1.

As illustrated in Figure 1, the first half 36 includes extending hook members 62. Although two hook members 62 are illustrated, additional hook members can be provided if desired. Correspondingly, the second half 38 includes apertures 64 for receiving the hook members 62.

The apertures 64 and hook members 62 are so constructed and arranged that when the hook members are received within the apertures, and therefore the first half 36 and second half 38 are snapped together, the hook members cannot be removed from the apertures without easily observable damage to the hook members. This provides a tamper resistant device that once secured to the additive port 14 cannot be removed therefrom without great difficulty. Of course, other means for securing the halves 36 and 38 of the cap 34 together can be used. To provide an integral complete cap 34 when the first and second halves 36 and 38 are secured together, additionally, the first half includes an elongated member 66 that is designed to be received within a groove 68 in the second half.

Referring now to Figures 3 and 4, an embodiment of the cap 134 is illustrated. In the embodiment, the hook members 162 are modified so that they have an "arrow head" or triangular cross-sectional shape. Of course, although the Figures illustrate the hook member 162 as having a two-dimensional arrow-head construction, a three-dimensional arrow-head structure can also be utilized. When the hook members 162 are received in the corresponding apertures 164 they provide a secure lock between the halves 136 and 138. In all other aspects, the embodiment illustrates in Figures 3 and 4 is similar to that illustrated in Figures 1 and 2.

Referring now to Figures 4 and 5, another embodiment of the cap 234 is illustrated. The cap 234 is substantially similar to the cap 34 illustrated in Figures 1 and 2. In this regard, the cap 234 is designed to be secured to the additive port 14 of a container 10. However, in contrast to the caps 34 and 134 of Figures 1 and 2 and 3 and 4 , respectively, the cap 234 includes hook members 262 and aperture members 264 that are located within an interior 250 and 252 of the cap. Accordingly, this provides a further tamper resistant device in that even if one were to intentionally attempt to open the cap 234 by cutting or otherwise eliminating the hook members 262, because the hooks 262 and apertures 264 are located within the interior of the cap, they are not accessible when the cap is secured to the additive port.

In use, after a medicament or additive is injected into a container such as a parenteral container, the cap is secured around the additive port. To this end, one half of the cap receives within its interior the injection site portion of the additive port. The other half of the cap is then moved toward the half of the cap that has received the port. The hook members are then received within the apertures securing the cap to the port.

When the cap is so secured, it indicates to medical personnel that a medicament has been added to the container. Due to the cap's structure, accidental, and even intentional, removal of the cap is prevented. If the cap is removed, it will remove with it at least the injection site. Additionally, the cap prevents the injection, through the cap, of a further medicament.

It should be understood that various changes and modifications to the presently preferred embodiments described herein will be apparent to those skilled in the art. Such changes and modifications can be made without departing from the spirit and scope of the present invention and without diminishing its attendant advantages. It is therefore intended that such changes and modifications be covered by the appended claims.

Claims

WE CLAIM;

1. A cap for sealing an additive port, that includes an injection site, of a container comprising: a first part and a second part, the first part and second part being hingedly secured along a length thereof to each other allowing portions of the first part to be moved toward portions of the second part, the first part and second part defining an interior for receiving at least a portion of the additive port including the injection site, the first part and second part including means for securing the cap around the injection site preventing the removal of the cap without removing at least the injection site from the container.

2. The cap of Claim 1 wherein the interior defined by the first part and second part includes a collar circumscribing at least a portion of the interior thereof.

3. The cap of Claim 2 wherein the collar includes a plurality of teeth.

4. The cap of Claim 1 wherein the cap includes a wall member so constructed and arranged as to prevent a cannula from piercing the injection site when the cap is secured to the additive port.

5. The cap of Claim 1 wherein the first part includes apertures and the second part includes locking members to be received within the apertures.

6. The cap of Claim 5 wherein the locking members are hooks extending from the second part.

7. The cap of Claim 6 wherein the hooks have a triangular cross-sectional shape.

8. The cap of Claim 1 wherein the means for securing the cap around the injection site are located within an interior of the cap when the cap is secured around the additive port.

9. A cap for sealing an additive port, including an injection site, of a container comprising: first and second halves hinged together along a first edge of each allowing portions of the halves to move toward and away from each other; an interior defined by the halves for receiving at least a portion of the port and the injection site; means for securing a second edge of the first half to a second edge of the second half; and at least one of the first or second halves including means circumscribing an interior thereof for causing at least the injection site to be removed upon the application of a sufficient pulling force when the cap is secured to the additive port.

10. The cap of Claim 9 wherein the means includes a collar having a plurality of teeth.

11. The cap of Claim 9 wherein the^' cap includes a wall having a sufficiently great thickness to prevent a cannula from being inserted therethrough.

12. The cap of Claim 9 wherein the first part includes apertures and the second part includes locking members received within the apertures.

13. The cap of Claim 12 wherein the locking members are hooks extending from the second part.

14. The cap of Claim 13 wherein the hooks have a triangular cross-sectional shape.

15. The cap of Claim 9 wherein the means for securing the cap are located within an interior of the cap when the cap is secured around the additive port.

16. The cap of Claim 9 wherein when the cap is secured around the additive port, the means circumscribing the interior is located in juxtaposition an outer extending end of the injection site.

17. A cap for providing a tamper resistent and tamper evident closure for an additive port having an injection site comprising: a first half including along a first edge extending hook members; a second half including along a first edge apertures for receiving the hook members; a hinge for hinging a second edge of each of the first and second halves together; the first half and second half cooperating to define an interior for receiving at least a portion of the injection site, the interior including a collar having extending teeth that circumscribes the interior; and the first and second halves cooperating to prevent the removal of the cap from the additive port, once the cap is secured thereon without the removal of the injection site.

18. The cap of Claim 17 wherein the cap includes a wall having a sufficiently great thickness to prevent a cannula from being inserted therethrough.

19. The cap of Claim 17 wherein the hook members and apertures are located within an interior of the cap when the cap is secured around the additive port.

20. The cap of Claim 17 wherein when the cap is secured around the additive port the means circumscribing the interior is located in juxtaposition to an outer extending end of the injection site.