WO2014116883A1

WO2014116883A1 - Device for improved prevention of infectious contamination in intravenous ("iv") components

Info

Publication number: WO2014116883A1
Application number: PCT/US2014/012835
Authority: WO
Inventors: Brent BORODIC
Original assignee: University Of Vermont And State Agricultural College
Priority date: 2013-01-23
Filing date: 2014-01-23
Publication date: 2014-07-31

Abstract

A fitting for a fluid-carrying tube is provided. The fitting includes a housing and a cover. A coupling, such as a Luer coupling, is at least partially disposed within the housing such that, when in a closed position, the cover and housing will reduce the risk of contamination of a mating end of the coupling. A primary tube is disposed through the housing and includes a coupling, such as an IV coupling on an end. The coupling includes a mating end which can be disposed in a recessed portion of the cover. In another embodiment, the present disclosure is as an enclosure, having a housing and a cover configured to enclose an IV coupling.

Description

DEVICE FOR IMPROVED PREVENTION OF INFECTIOUS CONTAMINATION IN INTRAVENOUS ("IV") COMPONENTS

Cross-Reference to Related Applications

[0001] The present application claims the benefit of the earlier filing date of U.S.

Provisional Patent Application Number 61/755,480, filed January 23, 2013, now pending, the disclosure of which is incorporated herein by this reference.

Field of the Invention

[0002] The disclosure relates to equipment for protecting medical equipment from contamination, and more particularly to medical fluid fittings. Background of the Invention

[0003] Each year, an estimated 1.7 million infections are acquired by patients in hospitals. Some amount of these infections are thought to be caused by microorganisms entering the body by way of intravenous ("IV") equipment. Because of the need for frequent access to the vasculature of a patient, IV equipment must be reconfigurable, and, therefore, includes standardized fittings and couplings that allow easy, fluid-tight insertion and removal of IV components. For example, a patient may have an IV line inserted, and the IV line is periodically used to inject medicaments. In this example, a syringe containing the medicament may be connected to a fitting of the IV line, a bolus may be injected through the line, and the syringe is removed. Another syringe may contain a "flush," which may be, for example, saline, in order to push the medicament completely into the patient and flush any blood and other fluid out of the line to prevent closure. Other IV components may include syringe pumps, infusion pumps/bags, etc.

[0004] Luer fittings are ubiquitous in today's hospital setting to provide for standardized, fluid tight connection of IV components. Luer fittings include a male end and a female end and the fittings generally include a cap in order to maintain the sterility, or at least cleanliness, of the fitting. However, over time the caps may become displaced, misplaced, or left off due to the nature of the activity in a hospital (e.g., the urgency with which activity may occur in an emergency room or an intensive care unit). IV lines may remain in patients for days or longer and the components remaining with the patient are exposed to microorganisms throughout this period. [0005] Many attempts have been made to combat against infection. It is common practice to swab a fitting with an alcohol swab before connection with another IV component fitting. However, such swabbing is often ineffective due to the time required for hygienic swabbing and/or the configuration of the fittings themselves. Alternative fitting configurations, covering films, and other potential solutions have been proposed, but, to date, none have had success in the field.

Brief Summary of the Invention

[0006] The present disclosure may be embodied as a fitting for a fluid-carrying tube comprising a housing and a cover. A coupling, such as a Luer coupling, is at least partially disposed within the housing. The fitting may comprise a primary tube disposed through an inlet hole in the housing and the coupling may be disposed on a distal end of the primary tube. The coupling has a mating end, which can be, for example, a Luer-type connector, including a clave needle free connector, or any other connector suitable for use with an IV fitting. The housing and cover are configured to enclose the mating end of the coupling when the cover is in a closed position eliminating the need for screw-on freestanding caps.

[0007] The cover may include a recessed portion for receiving the mating end of the coupling. The recessed portion may further comprise an antiseptic landing, which may comprise an antiseptic agent. In this manner, the cover may serve not only to prevent contamination of the coupling by enclosing the coupling, but also to reduce the amount of contamination of the coupling by cleansing with antiseptic agents.

[0008] The coupling may further comprise a stopcock and a handle for operating the stopcock. The stopcock allows the fluid flow through the coupling to be selected by an operator.

[0009] Fittings embodying the present disclosure may include more than one coupling, each having a mating end. Each coupling in such embodiments may have a stopcock. The fitting may further comprise a through tube for "upstream" connection to other IV components.

[0010] The present disclosure may be embodied as an enclosure, having a housing and a cover configured as described above, for enclosing an IV coupling. Description of the Drawings

[0011] For a fuller understanding of the nature and objects of the disclosure, reference should be made to the following detailed description taken in conjunction with the

accompanying drawings, in which: Figure 1 A is a side view of a device according to an embodiment of the present

disclosure;

Figure IB is a side view diagram of the device of Fig. 1A;

Figure 2 is a top view diagram showing a device according to another embodiment of the present disclosure;

Figure 3A is a perspective view of a device according to another embodiment of the present disclosure;

Figure 3B is a side perspective view of the device of Fig. 3 A;

Figure 3C is another perspective view of the device of Figs. 3A and 3B;

Figure 4 is a perspective diagram showing a device according to another embodiment of the present disclosure;

Figure 5 A shows a device according to an embodiment of the present disclosure, wherein the cover is in a closed position;

Figure 5B shows the device of Fig. 5B with the cover in an open position;

Figure 6 shows a device according to another embodiment of the present disclosure wherein the cover is being closed;

Figure 7 shows a device according to another embodiment of the present disclosure wherein the cover is being closed;

Figure 8 shows a device according to an embodiment of the present disclosure, wherein the device is connected to two syringes and an additional IV tube;

Figure 9 is a perspective diagram of a device according to another embodiment of the present disclosure;

Figure 10 is a perspective diagram of a device according to another embodiment of the present disclosure; and

Figure 11 is a flowchart of a method according to another embodiment of the present disclosure. Detailed Description of the Invention

[0012] With reference to Figs. 1A and IB, the present disclosure may be embodied as a fitting 10 for a fluid-carrying tube, such as an intravenous ("IV") tube commonly used in the medical field (see, for example, Fig. 1). The fitting 10 comprises a housing 12 which has a utility opening 13. The housing 12 further includes a cover 14 attached to the housing 12. The cover 14 may be hingedly attached to the housing 12. In other embodiments, the cover 14 is slidingly arranged relative to the housing 12. Other arrangements between the cover 14 and the housing 12 (e.g., swivel, tethered, etc.) will be apparent in light of the present disclosure. The housing 12, the cover 14, or both may be constructed from a plastic such as the plastics commonly used in the medical field. The plastic may be translucent or transparent. The housing 12 and the cover 14 may be part of the same plastic structure with hinge portion begin a flexible portion of the structure, thereby allowing the cover 14 to move relative to the housing 12. The cover 14 may positively engage the housing 12, to provide feedback of proper engagement to the personnel operating the device. [0013] The fitting 10 comprises a coupling 30 with a mating end 32 and a tube end 34.

At least a portion of the coupling 30 is disposed within the housing 12. In this way, the mating end 32 of the coupling 30 is enclosed by the housing 12 and the cover 14. In some embodiments, the coupling 30 engages with a coupling hole 37 of the housing 12 such that the coupling 30 is partially enclosed by the housing 12 and cover 14. The coupling 30 may be affixed to the housing 12 at the coupling hole 37. For example, an adhesive may be used, the components may be welded to one another, or other bonding techniques may be used. In other embodiments, such as that depicted in Fig. 2, the coupling 130 is completely disposed within the housing 112. The housing 12 may be generally cylindrically shaped, and arranged to be coaxial with the coupling 30. In some embodiments, such as, for example, the coaxial arrangement, the housing 12 may be spaced apart from the coupling 30 over a length of the coupling 30 such that a corresponding coupling of another IV component may be mated with the coupling 30 (see, for example, Fig. 8).

[0014] The coupling 30 may be, for example, a Luer taper connector such as a Luer-Lock or a Luer-Slip. In some embodiments, the Luer coupling 30 is a "clave"— a self-closing, needle- free connector. The mating end 32 of the Luer coupling 30 is configured for connection to a mating end of a corresponding coupling of another IV component. The Luer coupling 30 of the fitting 10 may be a male end or a female end of a coupling arrangement. It should be noted that the terms Luer, Luer-Lock, clave, etc. are used interchangeably herein to describe any type of Luer taper connectors standard in the medical field and should not be consider limiting unless stated as such.

[0015] The coupling 130 may be attached to and/or in fluid communication with a primary tube 120 having a proximal end 122 and a distal end 124 (see, for example, Fig. 2). The coupling 130 may be disposed on the distal end 124 of the primary tube 120. For example, the tube end 134 of the coupling 130 may be in fluid engagement with the distal end 124 of the primary tube 120. The coupling 130 is configured for fluid communication between the mating end 132 and the distal end 124 of the primary tube 120. In this manner, fluid entering the mating end 132 can travel "downstream" through the primary tube 120. It should be noted that the fitting 110 need not be limited as to the direction of fluid flow— such as, for example, where blood samples may be drawn "upstream" through the fitting 110.

[0016] In embodiments where the coupling 130 is enclosed within the housing 112, an attached primary tube 120 may be disposed through an inlet hole 116 of the housing 112 such that the distal end 124 of the tube is contained within the housing 112. The proximal end 122 may be configured for connection to other IV components between the housing 112 and a patient. The proximal end 122 may be configured with an insertion portion for insertion into a patient. In the manner, the primary tube 120 may be considered to be on a downstream "side" of the fitting 110. [0017] The cover 114 may include a recessed portion 118 which is configured to receive the mating end 132. The recessed portion 118 is configured for close fit to the mating end 132 and may include at least a portion of the a side wall 133 of the mating end 132. The recessed portion 118 may be configured to "float," wherein the cover does not make contact with a face of the mating end 132, or the recessed portion 118 may be configured to make contact with some or all of the mating end 132. The mating end 32 of the coupling 30 may be set back from the utility opening 13 of the housing 12 (see, for example, Fig. IB). For example, the mating end 32 may be set back from the opening by up to 1, 2, 3, or 4 mm or more (or any value in between). In this manner, the mating end 32 is less likely to come into accidental contact with a contaminated surface. [0018] The recessed portion 118 may further comprise an antiseptic landing 119. The antiseptic landing 119 is configured to contact the mating end 132 when the cover 114 is closed with respect to the housing 112. The antiseptic landing 119 may comprise an antiseptic agent. In some embodiments, the antiseptic landing 119 comprises metal ions, such as, for example, silver salts, having desired properties (e.g., anti-bacterial, anti-microbial, etc.) The antiseptic landing 119 may comprise a pad 117 having an antiseptic agent disposed therein. For example, a pad 117 made from a fabric may be contain an antibacterial liquid. Exemplary antiseptic agents for the pad 117 include chlorhexidine, alcohol, or iodine. Other suitable agents will be apparent to those skilled in the art. In this manner, when the cover 114 of the fitting 110 is in a closed position, the mating end 132 will be in contact with the antiseptic landing 119 and the presence of infectious contaminants on the mating end 132 will be reduced. [0019] The cover 14 may be configured to engage with the utility opening 13 of the housing 12 when the cover 14 a "closed" position. As such, the Luer coupling 30 can be configured to float when enclosed by the housing 12 and cover 14. In some embodiments, the engagement of the housing 12 and cover 14 in the closed position is fluid-tight. In other embodiments, the cover 14 is configured to engage with the Luer coupling 30 when the cover 14 is in a closed position. Here again, the engagement of the cover 14 and Luer coupling 30 may be fluid-tight. In other embodiments, the cover 14 is configured to engage with an outer circumference of the housing 12.

[0020] Fig. 9 depicts an embodiment of a fitting 180 wherein the coupling 186 may further comprise a stopcock 188 for allowing an operator to selectively allow of disallow fluid flow through the coupling 186. The stopcock 188 may have a handle 189 for operating the stopcock 188. The handle 189 may be disposed through the housing 182 such that a

stopcock 188 disposed within a housing 182 may be used from a person from outside the housing 182 by way of the handle 189. Also shown in Fig. 9 is an embodiment which comprises a seal 192 such that the cover 184 and housing 182 may form a fluid-tight seal when closed. In some embodiments where a portion of the coupling 76 is disposed in the housing 72 (see, for example, Figs. 3A-3C), the stopcock 78 need not be disposed through the housing 72.

[0021] The fitting 110 may further comprise a through tube 190 for "upstream" connection to other IV components, shown in Fig. 2. For example, often an IV saline infusion is maintained for an extended period of time. Such a fitting may be appropriate for connection between the saline supply (upstream) and the patient (downstream). In this embodiment, the through tube 190 is configured for fluid communication with any upstream components, and the primary tube 180 is configured for downstream fluid communication. The coupling 30 and stopcock (if included) may be configured for selectively allowing the flow of fluid from a component (e.g., a syringe, etc.) attached at the mating end 32 of the coupling 30. The housing 12 and cover 14 serve to reduce the risk of contamination of the coupling 30.

[0022] The housing may contain a second coupling with a second mating end. In other embodiments (see, for example, Fig. 4), the housing 152 may contain one or more additional couplings each having a mating end. The cover 154 is configure to enclose the couplings in the housing 152. The cover 154 may comprise recessed portions 156, which may further comprise antiseptic landings 158. Fig. 4 depicts an embodiment where a fitting 150 comprises a housing 152 and a cover 154, which contain three couplings 160 each having a mating end 162. In this exemplary embodiment, each coupling 160 also includes a stop cock 166 and a handle 168. In other embodiments, for example, the fitting 70 depicted in Figs. 3A-3C, each coupling 76 has a corresponding housing 72 and cover 74.

[0023] The present disclosure may be embodied as an enclosure 100 for use with an existing Luer-type coupling (see, for example, Fig. 10). As such, the enclosure 100 comprises a housing 102 and a cover 104 configured to contain one or more couplings, such as, for example, Luer-type couplings. The housing 102, the cover 104, or both may include one or more tube notches 106 configured so that an IV tube may enter the interior space of the enclosure 100.

[0024] The present disclosure may be embodied as a method 200 for providing a closure for a Luer coupling. The method 200 comprises the step of providing 203 a housing having a coupling hole, a utility opening, and a cover attached to the housing, wherein the cover is configured to selectably close the utility opening. The provided 203 housing may be any of the configurations noted within. The method 200 further comprises the step of engaging 206 the Luer coupling with the coupling hole of the housing such that at least a portion of the Luer coupling is enclosed by the housing and cover. The method 200 may further comprise the step of affixing 209 the coupling to the housing. For example, the housing may be affixed 209 by way of adhesive, welding, or other techniques known for bonding such materials.

[0025] Although the present disclosure has been described with respect to one or more particular embodiments, it will be understood that other embodiments of the present disclosure may be made without departing from the spirit and scope of the present disclosure. Hence, the present disclosure is deemed limited only by the appended claims and the reasonable

interpretation thereof.

Claims

We claim:

1. A fitting for IV tubing, comprising:

a Luer coupling having a mating end and a tube end;

a housing disposed on at least a portion of the Luer coupling, the housing having a utility opening and a cover, wherein the cover is attached to the housing and configured to selectively close the utility opening such that at least a portion of the Luer coupling is enclosed by the housing and cover;

2. The fitting of claim 1, wherein in a closed position, the cover engages with the utility opening.

3. The fitting of claim 2, wherein the cover and utility opening create a fluid-tight seal.

4. The fitting of claim 1, wherein in a closed position, the cover engages with the Luer coupling.

5. The fitting of claim 4, wherein the cover and the Luer coupling create a fluid-tight seal.

6. The fitting of claim 1, wherein the cover includes a recess portion configured to receive the mating end of the Luer coupling.

7. The fitting of claim 6, further comprising an antiseptic landing disposed in the recess portion of the cover.

8. The fitting of claim 7, wherein the antiseptic landing is a pad comprising an antiseptic substance.

9. The fitting of claim 8, wherein the antiseptic substance is selected from the group consisting of chlorhexidine, alcohol, iodine, and other antimicrobial substances.

10. The fitting of claim 1, wherein the Luer coupling further comprises a stopcock for selectably permitting fluid flow through the Luer coupling.

1 1. The fitting of claim 8, wherein the stopcock includes a handle disposed through the housing for operating the stopcock from outside the housing.

12. The fitting of claim 1, wherein the Luer coupling is a self-closing, needle-free connector.

13. The fitting of claim 1, wherein the Luer coupling is a Luer lock.

14. The fitting of claim 1, further comprising a second Luer coupling and a second housing disposed on at least a portion of the second Luer coupling.

15. The fitting of claim 14, wherein the Luer coupling and the second Luer coupling are arranged serially with respect to fluid flow through the primary tube.

16. The fitting of claim 1, further comprising a second luer coupling disposed within the housing, the second coupling having a second mating end.

17. The fitting of claim 1, wherein the Luer coupling is enclosed within the housing.

18. The fitting of claim 17, further comprising a primary tube having a distal end coupled to the tube end of the Luer coupling, and the primary tube is disposed through an inlet hole of the housing.

19. The fitting of claim 1, wherein the cover is hingedly attached to the housing.

20. The fitting of claim 1, wherein the cover is slidingly attached to the housing.

21. A method for providing a closure for a Luer coupling, comprising the steps of:

providing a housing having a coupling hole, a utility opening, and a cover attached to the housing, wherein the cover is configured to selectably close the utility opening; and engaging the Luer coupling with the coupling hole of the housing such that at least a portion of the Luer coupling is enclosed by the housing and cover.