Patent Description:
Although it is required to clean the hub or needless connector end of the tubing set, it is not required to clean the other end which is typically a male luer. Disinfection caps are increasingly being used to disinfect the ends of infusion therapy devices such as needleless connectors, IV sets, or short extension tubing. Such caps generally include foam soaked with alcohol which contacts surfaces of the port when the cap is connected to the port. Various problems exist when using these caps. For example, the alcohol soaked foam only contacts exterior surfaces of the access port. Also, once a cap is placed on a port, the alcohol in the cap evaporates quickly.

<CIT> relates to a closure system including a connector and a protective cap in which there is a liquid antiseptic. As the cap and connector are joined together, multiple seals are formed to trap the liquid antiseptic into a bore of the connector.

<CIT> relates to a cover for a proximal end of a connector attached to a catheter to receive an injection device. The cover comprises a body portion configured and dimensioned to receive at least a portion of an outer surface of the connector, a securement portion providing an engagement force on the connector for securing the cover to the connector, a removable cap having an internal portion with an anti-microbial agent, and a flexible member connecting the removable cap to the body portion.

<CIT> relates to a luer receiving medical valve for the sterile transfer of fluid forma luer-tapered male end having a surrounding female luer lock threaded end. The luer receiver includes a housing having an inlet and an outlet and a lumen extending from the inlet to the outlet. An elastomeric sealing member occludes the inlet and has a slit extending through it. The support includes opposing posts separated by slots, the slots permitting expansion of the sealing member when the male luer is inserted into the slit.

<CIT> relates to a medical device for forming a liquid communication path, comprising: joining members for forming the communication flow path between objects to be communicated with each other, and a protective cap having a tubular shape with a closed end, and holding a germicide-impregnated member at the deepest end of the protective cap. An inner peripheral surface of the protective cap forms a space for surrounding a tip of the joining member, and the dimensional relationship between the joining member and the protective cap is set so that the germicide-impregnated member faces the tip of the joining member with a spacing between the members. A sealing member is mounted to the inner peripheral surface of the opening end of the protective cap, and when the protective cap is in mounted state, the sealing member is pressed between the outer peripheral surface of the joining member and the inner peripheral surface of the protective cap to form an airtight structure for the space.

<CIT> relates to a pair of nestable caps, each of the caps being sized and shaped to provide a protective union about a separated medical connector. The pair comprises a male cap and a female cap, each of which is configured to be adjoined to a complimentary cap to form a nested pair. The nested pair is sealed until separated for use, thereby maintaining sterility of the intimal surface of the nested pair.

According to <CIT>, there are provided a male type connector, a protective cap, an inner cap that supports a disinfectant-impregnated member therein and is retained in the protective cap, and a female type connector in which an inner cylinder is fixed at an end of an outer cylinder, the inner cylinder including an internal end portion located inside the outer cylinder and an exposed external end portion. The inner cap includes engaging legs at each of which an engaging convexity is formed. A front end portion of the male type connector allows engaging convexities at the engaging legs to engage therewith from inside. An inner cap retaining portion is formed an inner wall surface of the protective cap, and a force exerted by the engagement between the inner cap and the male type connector is larger than a force exerted by the inner cap retaining portion to retain the inner cap. When the protective cap with the inner cap retained therein is fitted with the male type connector, and then is removed from the male type connector, the inner cap is retained in the male type connector and is detached from the protective cap. When the male type connector is connected with the female type connector, the internal end portion of the inner cylinder penetrates through the disinfectant-impregnated member, so that a channel is opened. When the connecting and detaching are repeated, the bacterial contamination can be reduced with a simple operation.

The present invention extends to a disinfection cap for disinfecting a male luer end of an infusion therapy device. The disinfection cap can include an internal reservoir containing an antimicrobial or saline solution which is sealed with a flexible septum to prevent the solution from evaporating. The septum can include one or more slits or pierceable seams that allow a male luer end of an infusion therapy device to be inserted through the septum and into the solution. While the male luer is inserted through the septum, the solution contacts both the inner and outer surfaces of the male luer. Because the septum reduces evaporation of the solution and prevents the solution from leaking out of the cap, the solution remains in contact with the male luer for a longer duration then when typical disinfection caps are used thereby increasing the effectiveness of the disinfectant.

According to the invention, the disinfection cap comprises an outer support structure having an open end, and a closed end opposite the open end; an inner support structure disposed entirely within the outer support structure and extending upwardly from the closed end of the outer support structure, a space interposed between an outer surface of the inner support structure and an inner surface of the outer support structure, the inner support structure having an open end in proximity to the open end of the outer support structure, the inner support structure containing an aqueous solution; and a septum attached to the open end of the inner support structure and forming a seal for maintaining the aqueous solution within the inner support structure, the septum comprising a slit or pierceable seam configured to permit an end of a male luer to pass through the septum and contact the aqueous solution.

In one embodiment, a disinfection cap comprises an outer support structure, an inner support structure, and a septum. The inner support structure has an inside diameter that is greater than the outside diameter of a male luer, and contains a solution for disinfecting the inner and outer surfaces of the male luer when inserted into the inner support structure. The septum is attached to a top surface of the inner support structure thereby forming a seal for maintaining the solution within the inner support structure. The septum is pierceable to allow a male luer to be inserted through the septum into the inner support structure.

In another embodiment, a disinfection cap comprises an outer support structure, an inner support structure, a frame, and a septum. The inner support structure has an inside diameter that is greater than the outside diameter of a male luer, and contains a solution for disinfecting the inner and outer surfaces of the male luer when inserted into the inner support structure. The frame is configured to be inserted into the cap. The septum attaches to the frame such that when the frame is inserted into the cap, the septum is secured to or against a top surface of the inner support structure thereby forming a seal for maintaining the solution within the inner support structure. The septum is pierceable to allow a male luer to be inserted through the septum into the inner support structure.

In another embodiment, a disinfection cap comprises an outer support structure, an inner support structure, and a silicone septum. The inner support structure has an inside diameter that is greater than the outside diameter of a male luer, and contains a solution for disinfecting the inner and outer surfaces of the male luer when inserted into the inner support structure. The silicone septum is secured to or against the inner support structure thereby forming a seal for maintaining the solution within the inner support structure. The silicone septum includes one or more slits that allow a male luer to be inserted through the septum into the inner support structure. The slits are configured such that when the male luer is inserted through the septum, the septum is secured around the outer surface of the male luer to inhibit the flow of solution out of the inner support structure.

Additional features and advantages of the invention will be set forth in the description which follows, and in part will be obvious from the description, or may be learned by the practice of the invention. The features and advantages of the invention may be realized and obtained by means of the instruments and combinations particularly pointed out in the appended claims. These and other features of the present invention will become more fully apparent from the following description and appended claims, or may be learned by the practice of the invention as set forth hereinafter.

<FIG> illustrates a perspective view of an exemplary disinfection cap <NUM> according to one or more embodiments of the invention. As shown, cap <NUM> includes an outer cylinder <NUM>, an inner cylinder <NUM>, and a septum <NUM> that is attached to the inner cylinder. Inner cylinder <NUM> can be configured to have a diameter that is larger than a standard female luer (i.e. larger than the outer diameter of the male luer) so that when the male luer is inserted into inner cylinder <NUM>, the solution in inner cylinder <NUM> can freely flow into and around the male luer.

Although cap <NUM> is shown as being configured as a cylinder <NUM>, other shapes can also be used such as a square, rectangle, oval, or other shaped outer surface. Also, cap <NUM> can have any reasonable length (e.g. to accommodate male luers of different lengths).

<FIG> illustrates a cross section view of cap <NUM> along with a male luer <NUM> of an infusion therapy device. As shown cap <NUM> includes a septum <NUM> that covers inner cylinder <NUM>. Septum <NUM> can provide a seal over inner cylinder <NUM> that inhibits the evaporation of solution <NUM> contained in inner cylinder <NUM>. Septum <NUM> can be made of any type of flexible material that deforms sufficiently to allow male luer <NUM> to be inserted through the septum while maintaining a substantial seal around male luer <NUM> to minimize the flow of solution <NUM> out of inner cylinder <NUM>. In some embodiments, septum <NUM> can be made of silicone.

Septum <NUM> includes one or more slits or pierceable seams 103a that facilitate inserting male luer <NUM> through septum <NUM>. In some embodiments, slits or seams 103a can extend out from the center of septum <NUM> to a distance that is less than the outer radius of male luer <NUM> so that a tight seal is formed between septum <NUM> and male luer <NUM> when the male luer is inserted through the septum.

<FIG> illustrates that male luer <NUM> has been inserted through septum <NUM>. As shown, slits or seams 103a have folded inwardly and are snug against the outer surface of male luer <NUM>. In this manner, solution <NUM> can be better retained within inner cylinder <NUM>, and evaporation can be limited. Solution <NUM> is thereby maintained in contact with the inner and outer surfaces of male luer <NUM> which increases the disinfectant effect on male luer <NUM>.

<FIG> illustrates that septum <NUM> can be configured to wrap around the top end of inner cylinder <NUM>. Because septum <NUM> can be made of a flexible elastic material, the septum can be attached to inner cylinder <NUM> in this manner without requiring any other means for securing the septum to the inner cylinder. Alternatively, additional means for securing the septum to inner cylinder can be used such as by gluing the septum to the inner cylinder.

<FIG> illustrates a septum <NUM> similar to the septum shown in <FIG>. However, the extensions of septum <NUM> in <FIG> extend nearly the full length of inner cylinder <NUM>. Accordingly, septum <NUM> can be configured with extensions of any length that wrap around a portion of inner cylinder <NUM>.

<FIG> illustrates an embodiment of cap <NUM> where inner cylinder <NUM> has a larger outer diameter at the bottom than at the top. A septum <NUM> with extensions of various lengths can be used in this embodiment. The increasing outer diameter of inner cylinder <NUM> can be used to better secure septum <NUM> to inner cylinder <NUM>.

Although <FIG> shows a linear increase in the outer diameter of inner cylinder <NUM>, in other embodiments, the outer diameter can be non-linear such as by including steps, ridges, or other non-linear increases to the outer diameter. Also, even though the outer surface of inner cylinder <NUM> is shown as and assumed to be circular, the outer surface can form another shape (e.g. an octagon or hexagon) or include any number of features (e.g. bumps, steps, or ridges) formed vertically on the outer surface.

<FIG> illustrates an embodiment of cap <NUM> where inner cylinder <NUM> further comprises a groove or cut configured to receive a locking feature of septum <NUM>. For example, in some embodiments the outer surface of inner cylinder <NUM> comprises an annular groove that is configured to receive an annular protrusion that is located on the inner surface of septum <NUM>. The interaction between the locking feature of septum <NUM> and the groove or cut of inner cylinder <NUM> securely locks septum <NUM> to inner cylinder <NUM>, as shown. Conversely, inner cylinder <NUM> may comprise an annular protrusion that is configured to be received by an annular groove located on the inner surface of septum <NUM>.

<FIG> illustrates an embodiment of cap <NUM> that employs a frame <NUM> for securing septum <NUM> to or against inner cylinder <NUM>. Frame <NUM> can comprise a ring that is shaped to be inserted between outer cylinder <NUM> and inner cylinder <NUM>. In some embodiments, frame <NUM> can be press fitted or glued to cap <NUM>. Also, in some embodiments, septum <NUM> can be attached to frame <NUM> (e.g. by gluing) before frame <NUM> is attached to cap <NUM>. Alternatively, septum <NUM> can be configured to attach to frame <NUM> after frame <NUM> has been attached to cap <NUM>.

<FIG> illustrates an embodiment of cap <NUM> that employs a frame <NUM> for securing septum <NUM> to or against inner cylinder <NUM>. Frame <NUM> can comprise a ring that has an outer diameter that is substantially the same as the inner diameter of inner cylinder <NUM>. Like frame <NUM>, frame <NUM> can be press fitted, glued, or otherwise attached to cap <NUM>. When frame <NUM> is used, the inner diameter of inner cylinder <NUM> can be increased if necessary to ensure that the inner diameter of frame <NUM> is greater than the outer diameter of male luer <NUM>. As with frame <NUM>, septum <NUM> can be attached to frame <NUM> either before or after frame <NUM> has been attached to cap <NUM>.

<FIG> and <FIG> illustrate a seal <NUM> that can be included on cap <NUM>. Seal <NUM> attaches to outer cylinder <NUM> to prevent evaporation of solution <NUM> from within inner cylinder <NUM> prior to seal <NUM> being removed. Seal <NUM> can be comprised of foil or any other material that can form a seal over cap <NUM>. As shown, seal <NUM> can include one or more tabs to facilitate the removal of the seal.

<FIG> and <FIG> illustrate different ways in which an antimicrobial solution can be applied to male luer <NUM>. In <FIG>, solution <NUM> comprises an antimicrobial solution. In such embodiments, male luer <NUM> does not need any antimicrobial coating. In contrast, in <FIG>, solution <NUM> comprises a saline, alcohol, or aqueous solution, and the outer surface of male luer <NUM> is coated with an antimicrobial coating. In such embodiments, the mixing of solution <NUM> with the antimicrobial coating disinfects both the outer and inner surfaces of male luer <NUM>. Any type of solution that can disinfect a surface can be used as solution <NUM>.

<FIG> illustrates how the septum can remove solution from male luer <NUM> as the male luer is removed from septum <NUM>. Because septum <NUM> is flexible and elastic, the septum maintains contact with the outer surface of male luer <NUM> as the male luer is removed. In this way, septum <NUM> in essence wipes the portions <NUM> of solution <NUM> that remain on the outer surface of male luer <NUM> as the male luer is removed. Removing solution <NUM> from male luer <NUM> is often desirable to minimize the amount of solution that can possibly enter the human body through the infusion therapy device.

Claim 1:
A disinfection cap comprising:
an outer support structure (<NUM>) having an open end, and a closed end opposite the open end;
characterized by
an inner support structure (<NUM>) disposed entirely within the outer support structure (<NUM>) and extending upwardly from the closed end of the outer support structure (<NUM>), a space interposed between an outer surface of the inner support structure (<NUM>) and an inner surface of the outer support structure (<NUM>), the inner support structure (<NUM>) having an open end in proximity to the open end of the outer support structure (<NUM>), the inner support structure (<NUM>) containing an aqueous solution(<NUM>) ; and
a septum (<NUM>) attached to the open end of the inner support structure (<NUM>) and forming a seal (<NUM>) for maintaining the aqueous solution (<NUM>) within the inner support structure (<NUM>), the septum (<NUM>) comprising a slit or pierceable seam (103a) configured to permit an end of a male luer (<NUM>) to pass through the septum (<NUM>) into the inner support structure (<NUM>) and contact the aqueous solution (<NUM>).