STERILIZED VASCULAR ACCESS ASSEMBLIES AND RELATED KITS AND METHODS

Abstract

This invention provides sterilized vascular access assemblies that include a sterilized needleless access connector (NAC) and a sterilized removable protective cap or cover capping or covering one or both of the NAC's fluid inlet and/or fluid outlet, and methods of making and using such assemblies, advantageously in the context of providing fluids, medication, and/or nutrition to patients in acute or long-term healthcare settings.

Claims

1. A sterilized vascular access assembly, comprising: a. a needleless access connector that defines a valved fluid flow path between a fluid inlet and a fluid outlet; and b(i). a removable protective cap or cover capping or covering the fluid inlet or fluid outlet, or b(ii). a first removable protective cap or cover capping or covering the fluid inlet and a second removable protective cap or cover capping or covering the fluid outlet, wherein each removable protective cap or cover is configured to substantially maintain sterility of at least a portion of a surface that defines an exterior of the fluid inlet or fluid outlet of the sterilized needleless access connector until the cap or cover is removed from the corresponding fluid inlet or fluid outlet, and wherein the assembly is sterilized.

2. A sterilized vascular access assembly according to claim 1 that comprises a removable protective cap threaded onto or into a corresponding structure on or in the fluid inlet or fluid outlet of the needleless access connector.

3. A sterilized vascular access assembly according to claim 2 wherein the fluid inlet and/or fluid outlet comprises a male or female luer structure matingly engaged with the removable protective cap.

4. A sterilized vascular access assembly according to claim 1 packaged in a sealed, sterilized package.

5. A sterilized vascular access assembly according to claim 4 wherein any removable protective cap or cover in the assembly is configured to substantially maintain sterility the corresponding fluid inlet or fluid outlet to which the cap or cover is matingly engaged for a period of up to about 30 days under standard hospital room conditions (20 C.-25 C. and an atmospheric pressure of 1 atmosphere) after removal from a sealed, sterilized package.

6. A sterilized vascular access assembly according to claim 1 disposed in a vascular access system connected to a patient to provide fluids, medication, and/or nutrition.

7. A sterilized vascular access extension set comprising a sterilized vascular access assembly according to claim 1.

8. A sterilized vascular access extension set according to claim 7 packaged in a sealed, sterilized package.

9. A sterilized vascular access extension set according to claim 7 disposed in a vascular access system connected to a patient.

10. A sterilized IV set comprising at least one sterilized vascular access assembly according to claim 1.

11. A sterilized IV set according to claim 10 packaged in a sealed, sterilized package.

12. A sterilized IV set according to claim 10 disposed in a vascular access system connected to a patient.

13. A method of maintaining sterility of an external surface of a needleless access connector, comprising configuring a sterilized vascular access assembly according to claim 1 as part of a vascular access system connected to a patient and leaving in place the cap or cover that caps or covers the fluid inlet of the needleless access connector until the needleless access connector is accessed for the first time, thereby maintaining sterility of an external surface of the needleless access connector until first fluid access.

14. A method of reducing healthcare-associated infection (HAI) risk, comprising configuring a sterilized vascular access assembly according to claim 1 as part of a vascular access system connected to a patient and leaving in place the cap or cover that caps or covers the fluid inlet of the needleless access connector, thereby reducing the risk that the patient will acquire an HAI.

15. A method of enhancing patient safety, comprising configuring a sterilized vascular access assembly according to claim 1 as part of a vascular access system connected to a patient and leaving in place the cap or cover that caps or covers the fluid inlet of the needleless access connector, thereby enhancing patient safety by reducing a risk that the patient will acquire an healthcare-associated infection (HAI).

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0026] Unless otherwise indicated, it is understood that the drawings are not to scale, as they are intended merely to facilitate understanding of the invention as opposed to specific dimensions, etc. In the drawings, like numbers in two or more drawings represent like elements. The illustrative embodiments described herein are not meant to be limiting. Other embodiments may be utilized, and other changes may be made, without departing from the spirit or scope of the subject matter presented here.

[0027] FIG. 1 depicts representative sterilized vascular access assemblies according to the invention.

DETAILED DESCRIPTION OF THE INVENTION

[0028] This invention concerns sterilized vascular access assemblies that include a sterilized needleless access connector (NAC) and a sterilized removable protective cap or cover capping or covering one or both of the NAC's fluid inlet and/or fluid outlet. Needleless access connectors play an important role in healthcare today as they serve to reduce the risk of inadvertent needle-stick injuries, particularly to healthcare workers. At least 1 billion such connectors are used annually in the U.S. in connection with providing peripheral venous and central line vascular access to patients. But because NACs serve as fluid access ports, they can also serve as access points for microbial pathogens. Indeed, they are known to be among the primary sources for catheter-related bloodstream infections, which result in significant morbidity and mortality among patients who receive central lines and/or peripheral IVs in connection with their medical treatments.

[0029] Here, a cap refers to a device that covers, protects, or shields at least part of a cylindrical portion of another device, such as the threaded male or female portion of a luer fitting on the fluid inlet or fluid outlet portion of a NAC. In the context of capping the fluid inlet portion of a NAC, which contains the part of the NAC's valve configured to be engaged by a complementary fitting to actuate the valve so that fluid can flow into and through the NAC via its engineered fluid pathway, a cap will, when matingly suitably engaged with the fluid inlet portion of the NAC, not only protect the accessible valve surface but also at least some (about 10% or more) of the threaded sidewall of the fluid inlet portion of the NAC. In some preferred embodiments, a cap covers all of the threaded region of a NAC's fluid inlet portion. A cover refers to a device that covers, protects, or shields the top portion of the cylindrical end of a NAC and not more than about 10% or less of the adjacent sidewall.

[0030] Each sterilized removable protective cap or cover is configured to substantially maintain sterility of at least a portion of a surface that defines an exterior of the fluid inlet or fluid outlet of the sterilized needleless access connector until the cap or cover is removed from the corresponding fluid inlet or fluid outlet.

[0031] Here, to substantially maintain sterility of a surface means to provide protection over time for a surface such that the surface is less susceptible to microbial contamination by a factor of 2, 5, 10, 100, 1,000, 10,000, 100,000, 1,000,000, 10,000,000, 100,000,000, or a billion, 10 billion, 100 billion, 1 trillion or more, as compared to an equivalent surface that has not been so protected. Such time periods can range from, for example, about 1 hour to about 30 days under standard hospital room conditions (20 C.-25 C. and an atmospheric pressure of 1 atmosphere) after removal from a sealed, sterilized package. In addition to serving to substantially maintain sterility, the caps and/or covers used to cap or cover NAC fluid inlets in the assemblies of the invention will also serve to prevent inadvertent or accidental actuation of the valve portion of the protected NAC, thereby reducing the risk that one or more contaminating microorganisms may gain entry into NAC's fluid pathway and thus potentially into the patient's vasculature and thereby possibly cause an HAI.

[0032] In embodiments that employ caps, the caps preferably thread onto or into a corresponding structure on or in the fluid inlet or fluid outlet of the sterilized needleless access connector to which the cap is attached. Examples of preferred threaded configurations include male and female luer fittings. In embodiments where one or more sterilized removable protective covers are used, attachment may be by way of adhesive, press fit, or any other suitable approach.

[0033] Preferably, sterilized vascular access assemblies of the invention are packaged in sealed, sterilized packaging, with or without labels, instructions for use, and the like. Sterilization of the devices, assemblies, kits, and packages of the invention can be accomplished by any suitable sterilization method compatible with the components to be sterilized. Preferred methods include gamma or electron beam irradiation. Preferably, sterilization of an assembly occurs after it has been suitable packaged.

[0034] As will be appreciated, the sterilized vascular access assemblies of the invention are designed for use in connection with providing vascular access to patients. Typically this is by way of inclusion in a vascular access system (e.g., an IV bag, IV set, extension set, and IV catheter inserted into a peripheral vein) connected to a patient to provide fluids, medication, and/or nutrition to the patient. Other vascular access systems include central lines, including peripherally inserted central lines.

[0035] In many preferred embodiments, the sterilized vascular access assemblies of the invention are included as part of a sterilized vascular access extension set and/or sterilized IV set.

Representative Embodiments of the Invention

[0036] FIG. 1 shows two representative sterilized vascular access assemblies according to the invention.

[0037] The embodiment shown on the left shows a NAC (100) that defines a valved fluid flow path between a fluid inlet (104) and a fluid outlet (106). The NAC includes a valve region (110) that has threads (102) to facilitate connection to other components that have complementary threaded regions. The assembly also includes a removable first protective cap (150) for capping or covering the NAC's fluid inlet (104) and a removable second protective cap (160) for capping the fluid outlet (106). The removable first protective cap (150) includes complementary threads (152) to the threads (102) on the NAC's valve region (110). The removable first protective cap (150) defines a cavity (154) designed to accept the NAC's valve region (110) so as to cap, protect, and maintain the sterility of the NAC's valve region (110) after the assembly has been assembled and sterilized. The assembly's second protective cap (160) defines a cavity (164) designed to accept the NAC's male luer taper so as to cap, protect, and maintain the sterility of the male luer taper after the assembly has been assembled and sterilized.

[0038] The embodiment shown on the left shows a NAC (101) that defines a valved fluid flow path between a fluid inlet (105) and a fluid outlet (107). The NAC includes a valve region (111) that has thread tabs (103) to facilitate connection to other components that have a complementary threaded region. The assembly also includes a removable first protective cap (151) for capping or covering the NAC's fluid inlet (105) and a removable second protective cap (161) for capping the fluid outlet (107). The removable first protective cap (151) includes complementary thread tab acceptors (153) to the thread tabs (103) on the NAC's valve region (111). The removable first protective cap (151) defines a cavity (155) designed to accept the NAC's valve region (111) so as to cap, protect, and maintain the sterility of the NAC's valve region (111) after the assembly has been assembled and sterilized. The assembly's second protective cap (161) defines a cavity (166) designed to accept the NAC's male luer taper so as to cap, protect, and maintain the sterility of the male luer taper after the assembly has been assembled and sterilized.

[0039] Unless the context clearly requires otherwise, throughout the description above and the appended claims, the words comprise, comprising, and the like are to be construed in an inclusive sense as opposed to an exclusive or exhaustive sense; that is to say, in a sense of including, but not limited to. Words using the singular or plural number also include the plural or singular number, respectively. Additionally, the words herein, hereunder, above, below, and words of similar import refer to this application as a whole and not to any particular portions of this application. When the word or is used in reference to a list of two or more items, that word covers all of the following interpretations of the word: any of the items in the list, all of the items in the list, and any combination of the items in the list.

[0040] The foregoing description, for purpose of explanation, has been described with reference to specific embodiments. However, the illustrative discussions above are not intended to be exhaustive or to limit the invention to the precise forms disclosed. Many modifications and variations are possible in view of the above descriptions. The embodiments were chosen and described in order to best explain the principles of the invention and its practical applications to thereby enable others skilled in the art to best utilize the invention and various embodiments with various modifications as are suited to the particular use contemplated. As such, the invention extends to all functionally equivalent structures, methods, and uses, such as are within the scope of the appended claims, and it is intended that the invention be limited only to the extent required by the applicable rules of law.

[0041] Any patent or patent application referenced herein is hereby incorporated by reference in its entirety.