US20140155868A1

US20140155868A1 - Sheath

Info

Publication number: US20140155868A1
Application number: US14/131,426
Authority: US
Inventors: David Nelson; Nicholas Lopez; Alison D. Burcar
Original assignee: ICU Medical Inc
Current assignee: ICU Medical Inc
Priority date: 2011-07-08
Filing date: 2012-06-27
Publication date: 2014-06-05
Also published as: WO2013009478A1; US20200009365A1

Abstract

A sheath can be used to protect a catheter hub from contamination. The sheath can surround the catheter hub and seal the interface between the catheter hub and a needleless connector. The sheath can be installed onto the catheter hub either before or after the needleless connector has been connected to the catheter hub.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to U.S. provisional application No. 61/505,961 filed Jul. 8, 2011. The entire contents of the above are incorporated by reference herein.

BACKGROUND OF THE DISCLOSURE

1. Field of the Disclosure
Embodiments relate generally to medical catheter systems through which fluids flow, and in particular, to sheaths or covers related to catheter hubs and needleless medical connectors.
2. Description of the Related Art
Catheter systems of connectors, valves, and tubing are routinely used in hospitals and other medical settings to facilitate the transfer of fluids to and from patients. Efforts are routinely made to follow aseptic practice to combat contamination.

SUMMARY OF SOME EMBODIMENTS

A sheath can be used to seal and/or cover various parts of a catheter system to prevent contamination from entering the catheter system. A sheath as will be described herein can be used to reduce the chance of infection.
A sheath can comprise a flexible housing configured to sealingly engage medical tubing at one end and to sealingly engage and cover a connection between a catheter hub and a needleless connector.
According to some embodiments, a sheath can have a flexible housing. The flexible housing can comprise a first end configured to cover and create a fluid tight seal around a connection between a catheter hub and a needleless connector and a second end spaced from the first end such that the housing completely encloses the catheter hub. The flexible housing can be configured for initial attachment to the catheter hub independent of whether the needleless connector is already connected to the catheter hub and can be configured to tear so as to facilitate removal.
In some embodiments, the flexible housing can be configured to be removed by destruction such as being configured to preferably tear along the sides in two locations generally parallel with one another or to break into two pieces, rendering the device unusable thereafter.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other features, aspects, and advantages are described below with reference to the drawings, which are intended to illustrate but not to limit embodiments of the invention. In the drawings, like reference characters denote corresponding features consistently throughout similar embodiments.

FIGS. 1 and 2 illustrate an embodiment of a sheath coupled to a catheter hub and a needleless connector.

FIG. 3 shows a cross-section of the system shown in FIG. 2.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

A sheath 10 can be used to seal, cover, and/or protect various parts of a catheter system. The sheath 10 can beneficially be used to reduce contamination or bacteria from entering the blood stream of a patient. In some embodiments, the sheath 10 can be disposable and can be an easily replaceable part of a catheter system. In this way, the sheath 10 can be a sacrificial first line of defense for the catheter system. When the sheath 10 is removed, it preferably takes any contaminates from the site along with it. This can prevent direct contact with, and contamination of, sensitive and/or important areas of a catheter system of connectors, valves, and tubing. The site can then be better prepared for any necessary additional action such as, for example, connecting or disconnecting connectors, valves, and tubing.
The connection or access portions of the catheter system can be considered the weak points or danger points where there is significant risk of spreading disease to the patient. The connection locations and access sites generally allow direct contact or access to the blood stream. This can occur, if for example, the connection is loosened, or changed, a connection is made, or components are replaced. If proper procedures are not taken, bacteria can enter the blood stream causing infection. Even when proper procedures are taken, there is still a risk of infection.
A sheath 10 can be used to reduce the risk of infection. Some embodiments of a sheath 10 can protect an access site and then be removed, thereby removing contaminates from the site. The newly exposed section of the catheter system can be handled in a sterile manner for whatever actions are desired and then a new sheath can be added to the system. The sheath acts as a barrier to prevent the underlying areas from contacting potentially harmful or contaminating substances, surfaces, and/or objects.
FIGS. 1-3 illustrate part of a catheter system where a sheath 10 is used to cover a catheter hub 40 (FIG. 3) and the connection between the catheter hub 40 and a needleless or needle-free connector 20. The catheter hub 40 can be connected to tubing 30.
The sheath 10 can protect the catheter hub 40 from contacting potentially contaminated surfaces. The sheath 10 can be used to establish a barrier between a section of the catheter system and its surroundings.
The catheter system can be used for many purposes, such as intravenous infusion and/or withdrawal of fluids. For example, the catheter hub 40 and tubing 30 could be part of a peripherally inserted central catheter (PICC or PIC line). A PICC is inserted in a peripheral vein, such as the cephalic vein, basilic vein, or brachial vein and then advanced through increasingly larger veins, toward the heart until the tip rests in the distal superior vena cava or cavoatrial junction.
A PICC is generally placed in a patient for a long term treatment such as for long chemotherapy regimens, extended antibiotic therapy, or total parenteral nutrition. As has been mentioned, long term treatment increases the risk of infection. Thus, a sheath 10 can be used to decrease this risk.
Looking to FIGS. 1 and 2, it can be seen that the sheath 10 can completely enclose the catheter hub 40, such that the catheter hub cannot be seen or touched. In some embodiments, a clear or substantially transparent sleeve may be used which would facilitate assembly of the system. The catheter hub is connected to tubing 30 that protrudes out one end 12 of the sheath, while a needleless connector 20 connected to the other end of the catheter hub, protrudes out the other end 14 of the sheath 10. As shown, the needleless connector 20 is a version of the CLAVE® needleless connector with the male luer end 22 connected to the catheter hub 40 (FIG. 3). The needleless connector 20 also has a valved female luer end 24. One of many different types of needleless connectors can be used to connect to the catheter hub 40. In addition, the catheter hub could be one of many different types of catheter hubs.
The needleless connector 20 can be used to gain access into the catheter system, such as to inject medicaments or to withdraw blood. In typical use, a needleless connector 20 provides a sealed interface 24 that can be sterilized, such as with an antiseptic wipe, prior to connecting another device with the needleless connector, thereby opening the sealed interface and moving the valve 26 (FIG. 3).
As has been mentioned, the needleless connector 20 can attach to one end of the catheter hub 40. The sheath 10 can be used to seal the interface 32 between the catheter hub 40 and the needleless connector 20. The sheath can also enclose and surround the catheter hub 40. In this way, the sheath 10 can keep the catheter hub 40 and the interface 32 between the catheter hub 40 and the needleless connector 20 clean and generally free of debris.
As will be understood, the catheter hub 40 is connected to tubing 30 as part of a catheter system that may be implanted within a patient for an extended period of time. This period of time may be days, weeks, months, etc. As such, it may be generally desired that the catheter hub 40 remain in place and not be removed. As the catheter hub 40 is attached to the tubing 30 it can be difficult to remove the catheter hub without also replacing the tubing. It may be undesirable to replace the tubing for many reasons as will be known by those of skill in the art. In contrast, the needleless connector 20 can be easily removed and replaced.
Similarly, in some embodiments, the sheath 10 can also be easily removed and replaced. Thus, the sheath 10 can provide a flexible disposable barrier that surrounds the catheter hub 40. As the catheter hub 40 may remain in place as part of a catheter system in a patient for an extended period of time, the sheath 10 can beneficially protect the catheter hub from undesired contamination. The sheath 10 can also be removed after a certain time period taking any contaminates with it. The sheath 10 can then be replaced by a new sterile sheath 10. In some embodiments, the sheath 10 may be integrally formed with, or permanently connected to, connector 20 such that the sheath 10 is removed with the connector 20. The connector/sheath combination can then be replaced with a new connector/sheath combination or can be replaced with a connector and a separate sheath.
The installation and removal of the sheath will now be described.
The sheath 10 can be configured to fit over most catheter hubs and needleless connectors. This can be a result of many reasons including material selection and certain design features. For example, the sheath can have a flexible outer housing. In some embodiments, the outer housing can be elastomeric, or a portion can be elastomeric. The elastomeric portion can be stretched as the sheath 10 is passed over the catheter hub and/or needleless connector.
The sheath 10 can slip over the catheter hub 40 either before or after a needleless connector 20 has been connected to the catheter hub 40. As the sheath 10 can have a flexible outer housing, the sheath 10 can be forced to pass over the catheter hub 40 and/or needleless connector 20. The outer housing can expand and move in a flexible manner as needed to reach the desired position.
In some embodiments, the sheath can be actuated or otherwise acted upon to open an end 12 of the sheath 10. For example, the end 12 or a middle section 16 can be pinched by a user's fingers to cause the end 12 to open to allow the catheter hub 40 and/or needleless connector 20 to pass through the sheath 10.
The end 12 of the sheath 10 can be configured to close or to substantially close around the tubing 30. In some embodiments, the end 12 includes a closure system 18. The closure system 18 can be a tongue and groove system where the tongue is configured to fit within the groove when the sheath is attached to the catheter hub 40. The closure system can also include sidewalls that are forced into contact one with the other. Other configurations are also possible.
The end 12 of the sheath can also include a passageway 28 that passes through the end 12. The passageway 28 can be permanent or temporary or can only open in certain positions of the sheath 10, such as when the sheath is installed on the catheter hub 40. The passageway can be configured such that the tubing 30 passes through the passageway 28. In some configurations, the tubing and passageway 28 and/or end 12 can form a first peripheral seal 50 such that the sheath 10 sealingly engages the sidewalls of the tubing 30, while still allowing the tubing to pass through the end 12. The seal 50 can be a water-tight or a near water-tight seal.
The end 14 of the sheath can be sized to accept the needleless connector 20 and form a second peripheral seal 52 along the sides of the needleless connector 20. In some embodiments the second seal 52 can be formed at or near the connector end 22. Alternatively it may be positioned at other locations along the connector 20. The sheath 10 can also seal the interface 32 between the catheter hub 40 and the needleless connector 20. An internal seal 54 can also be formed in some configurations between a radially extending portion 42 of the catheter hub 40 and the end 22 of the needleless connector 20. As shown, the end 22 of the needleless connector 20 includes internal male luer threads and an end surface 22 a. In some embodiments the sheath 10 can be positioned between the end surface 22 a and the radially extending portion 42 to create a washer-like seal. Whether the seal 54 is formed can depend on the particular size and configuration of the catheter hub and needleless connector chosen.
The seals 50, 52, 54 around the catheter hub and the needleless connector can be water-tight or near water-tight. Where a portion of the sheath is elastomeric, stretching of the elastomeric material can be used to create a seal between the sheath 10 and one or more of the catheter hub 40, the needleless connector 20, and/or the tubing 30.
In some embodiments, the needleless connector 20 can be attached to the catheter hub 40 either before or after the sheath 10 has been attached to the catheter hub 40. Thus, the needleless connector can be removed and/or replaced without removing the sheath 10. In addition, the sheath 10 can maintain the catheter hub 40 and a portion of the tubing in an enclosed, protected and sealed state independent of the placement of the needleless connector.
In alternative embodiments, the sheath 10 can be made integrally with the needleless connector 20. In this configuration removing the needleless connector would also remove the sheath.
Returning to FIG. 3, it can be seen that in some embodiments the sheath 10 has an internal chamber 34. The internal chamber 34 can enclose a portion of the tubing 30 as well as the catheter hub 40. The sheath end 12 can be spaced away from the catheter hub 40 to also enclose a section of the tubing 36 adjacent the catheter hub 40. This can provide additional protection such that when the sheath is removed there is a decreased risk of contamination getting into or on the catheter hub. Thus, there is also a corresponding decreased risk of infection. In some embodiments, the chamber 34 can include a disinfectant, antibacterial, or antimicrobial solution or other material to increase the effectiveness of the barrier. In some embodiments, the sheath 10 itself may include or exude a disinfectant, antimicrobial, or antibacterial material.
The length of tubing 36 adjacent the catheter hub 40 that is enclosed within the sheath 10 can be as long, longer or shorter than the catheter hub itself.
In some embodiments, the sheath 10 can be configured to be non-reusable and/or removed by destruction. Removal by destruction can prevent a used and contaminated sheath 10 from being reused. For example, the sheath 10 can be configured to break or tear along a release portion 38. The sheath 10 can utilize one or more seams, thin walled sections, tear away sections, etc., or combinations thereof to create the release portion 38. The release portion 38 can be used to cause the sheath 10 to separate from the other components of the catheter system. For example, portions of the sheath 10 can be pulled in opposite directions causing the release portion 38 to break or tear and the sheath 10 to split apart. The release portion 38 can extend along a portion of or the entire sheath 10.
In some typical uses of a catheter system, the needleless connector 20 is often removed from the catheter hub 40 and replaced with a new needleless connector after a period of time, for example 3 days. A sheath can beneficially be added to such a system. The sheath 10 can also be removed and replaced at the same time as the needleless connector 20. For example, the sheath 10 can be ripped off the catheter hub, utilizing the release portion 38. The needleless connector can then be removed. Afterwards, a new sheath can be connected to the catheter hub, followed by a new needleless connector. In this manner contaminants can be removed from the site with the removal of the sheath before the needleless connector is removed which opens the injection site to exposure to air and potential contaminant
The sheath 10 can provide many benefits. For example, the sheath can cover all or part of a section of a catheter system. This can allow the section to remain protected from contacting potentially harmful or contaminated surfaces or objects. Also, the sheath can be removed and replaced with a new sterile sheath. This removes any contaminates at the site and can further reduce the risk of infection.
Embodiments of the sheath can be added at one of many different times in the assembly procedure, such before or after the needleless connector has been connected to the catheter hub. Some embodiments of the sheath also seal the catheter hub at one end while enclosing some or the entire catheter hub and can form a seal with the body of the catheter hub while still allowing for connection to or disconnection from a needleless connector, thereby providing a protected catheter hub.
Some embodiments of the sheath can be non-reusable and disposable. Embodiments can be removed by destruction to prevent the sheath from being reused and potentially contaminating the catheter hub. Embodiments can have tear away portions and can be removable and separable from all other pieces.
Although this invention has been disclosed in the context of certain embodiments and examples, it will be understood by those skilled in the art that the invention extends beyond the disclosed embodiments to other alternative embodiments and/or uses of the invention and obvious modifications and equivalents thereof. Additionally, it is contemplated that various aspects and features of embodiments of the invention described can be practiced separately, combined together, or substituted for one another, and that a variety of combination and sub-combinations of the features and aspects can be made and still fall within the scope of the invention. Thus, it is intended that the scope of the invention should not be limited by the above description, but should be determined only by the claims.

Claims

What is claimed is:

1. A sheath for use with a medical line connection site, comprising:

a housing having:

a first end configured to cover and sealingly engage a first connector;

a second end spaced from the first end and configured to sealingly engage a second connector, the first and second connectors configured for connection to one another;

wherein the housing is configured for initial attachment to the first connector independent of whether the first connector is already connected to the second connector and further configured for irreversible removal such that the housing is no longer able to sealingly engage at least one of the first connector and the second connector after said irreversible removal.

2. The sheath of claim 1, wherein the housing further comprises at least one release portion configured to break or tear such that the housing can be irreversibly removed.

3. The sheath of claim 1, wherein the release portion comprises at least one of a seam, a thin walled section, or a tear away section.

4. The sheath of claim 1, wherein the at least one release portion is configured to divide the housing into at least two pieces.

5. The sheath of claim 1, wherein the at least one release portion is configured to irreversibly open the housing to expose an inside surface.

6. The sheath of claim 1, wherein the housing comprises a flexible housing configured to flex to pass over and advance onto at least one of the first and the second connector.

7. The sheath of claim 1, wherein the first end of the housing is configured to have an initial condition prior to attachment, an engagement condition during sliding engagement with at least the first connector and an attached configuration, wherein the second end comprises an opening and the opening is configured to be largest in the engagement condition.

8. The sheath of claim 1, wherein the housing is further configured to enclose a section of tubing connected to the first connector.

9. The sheath of claim 1, wherein the first end of the housing comprises a tongue and groove joint.

10. A sheath comprises:

a flexible housing configured to sealingly engage medical tubing at one end and to sealingly engage and cover a connection between a catheter hub and a needleless connector.

11. A sheath for selectively covering an interface between a closeable connector and a catheter hub with tubing comprising:

a first end configured to engage the connector;

a second end with a tongue and grove closure configured to engage the catheter hub or the tubing.

12. The sheath of claim 11, wherein the first end is configured to be permanently attached to the connector.

13. The sheath of claim 11, wherein the tongue and groove has a hole configured to selectively sealingly engage the catheter hub.

14. The sheath of claim 11, wherein the tongue and groove has a hole configured to selectively sealingly engage the tubing.

15. A system for use with an intravenous medical treatment of a patient, comprising:

a sheath with a flexible housing having:

a first end configured to cover and create a fluid tight seal around a connection between a catheter hub and a needleless connector;

a second end spaced from the first end such that the housing completely encloses the catheter hub;

the flexible housing configured for initial attachment to the catheter hub independent of whether the needleless connector is already connected to the catheter hub and configured to tear so as to facilitate removal.

16. The system of claim 15, wherein the first end is configured to have an initial condition prior to attachment with an initial inner diameter and an attached condition having an attached inner diameter, wherein the initial inner diameter is less than the attached inner diameter.

17. The system of claim 16, wherein the first end is configured for sealing engagement with the needleless connector.

18. The system of claim 15, wherein the second end is configured to have an initial condition prior to attachment, an engagement condition during sliding engagement with at least the catheter hub and an attached configuration, wherein the second end comprises an opening and the opening is configured to be largest in the engagement condition.

19. The system of claim 15, further comprising at least one of the catheter hub and the needleless connector and wherein the connection between the catheter hub and the needleless connector is a luer connection.

20. The system of claim 15, wherein the flexible housing is further configured to enclose a section of tubing connected to the catheter hub.

21. The system of claim 15, wherein the flexible housing is configured to tear along the sides in two locations parallel with one another.

22. The system of claim 15, wherein the flexible housing is configured to break into two pieces rendering the device unusable thereafter.

23. The system of claim 15, wherein the second end comprises a tongue and groove joint.

24. A method of replacing a needleless connector comprising:

assessing a first flexible sheath covering an interface connection between a first needleless connector and a catheter hub, the first flexible sheath completely covering the catheter hub;

damagingly removing the first flexible sheath from the interface connection between a first needleless connector and a catheter hub such that the first flexible sheath is rendered unusable;

disposing of the first flexible sheath;

removing the first needleless connector from the catheter hub;

connecting a second needleless connector to the catheter hub;

advancing a second flexible sheath over the second needleless connector and the catheter hub, the second flexible sheath being separate from the second needleless connector.

25. The method of claim 24, wherein the catheter hub comprises a first end and a second end, the first end having a luer connection and the second end integrally connected to tubing.

26. The method of claim 25, wherein the second flexible sheath has a first send and a second end, the second end having a tongue and grove closure configured to engage the catheter hub or the tubing, wherein advancing the second flexible sheath further comprises advancing the second flexible sheath until the tongue and grove engage either the catheter hub or the tubing.

27. The method of claim 24, wherein damagingly removing the first flexible sheath comprises tearing the first flexible sheath.

28. The method of claim 24, wherein damagingly removing the first flexible sheath comprises tearing the first flexible sheath into two separate pieces.

29. The method of claim 24, wherein damagingly removing the first flexible sheath comprises tearing along two seams.