US20140155868A1

Movatterモバイル変換

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 inFIG. 2.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

Asheath10 can be used to seal, cover, and/or protect various parts of a catheter system. Thesheath10 can beneficially be used to reduce contamination or bacteria from entering the blood stream of a patient. In some embodiments, thesheath10 can be disposable and can be an easily replaceable part of a catheter system. In this way, thesheath10 can be a sacrificial first line of defense for the catheter system. When thesheath10 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.

Asheath10 can be used to reduce the risk of infection. Some embodiments of asheath10 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 asheath10 is used to cover a catheter hub40 (FIG. 3) and the connection between thecatheter hub40 and a needleless or needle-free connector20. Thecatheter hub40 can be connected totubing30.

Thesheath10 can protect thecatheter hub40 from contacting potentially contaminated surfaces. Thesheath10 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, thecatheter hub40 andtubing30 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, asheath10 can be used to decrease this risk.

Looking toFIGS. 1 and 2, it can be seen that thesheath10 can completely enclose thecatheter hub40, 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 totubing30 that protrudes out oneend12 of the sheath, while aneedleless connector20 connected to the other end of the catheter hub, protrudes out theother end14 of thesheath10. As shown, theneedleless connector20 is a version of the CLAVE® needleless connector with themale luer end22 connected to the catheter hub40 (FIG. 3). Theneedleless connector20 also has a valvedfemale luer end24. One of many different types of needleless connectors can be used to connect to thecatheter hub40. In addition, the catheter hub could be one of many different types of catheter hubs.

Theneedleless connector20 can be used to gain access into the catheter system, such as to inject medicaments or to withdraw blood. In typical use, aneedleless connector20 provides asealed interface24 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 valve26 (FIG. 3).

As has been mentioned, theneedleless connector20 can attach to one end of thecatheter hub40. Thesheath10 can be used to seal theinterface32 between thecatheter hub40 and theneedleless connector20. The sheath can also enclose and surround thecatheter hub40. In this way, thesheath10 can keep thecatheter hub40 and theinterface32 between thecatheter hub40 and theneedleless connector20 clean and generally free of debris.

As will be understood, thecatheter hub40 is connected totubing30 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 thecatheter hub40 remain in place and not be removed. As thecatheter hub40 is attached to thetubing30 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, theneedleless connector20 can be easily removed and replaced.

The installation and removal of the sheath will now be described.

Thesheath10 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 thesheath10 is passed over the catheter hub and/or needleless connector.

Thesheath10 can slip over thecatheter hub40 either before or after aneedleless connector20 has been connected to thecatheter hub40. As thesheath10 can have a flexible outer housing, thesheath10 can be forced to pass over thecatheter hub40 and/orneedleless connector20. 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 anend12 of thesheath10. For example, theend12 or amiddle section16 can be pinched by a user's fingers to cause theend12 to open to allow thecatheter hub40 and/orneedleless connector20 to pass through thesheath10.

Theend12 of thesheath10 can be configured to close or to substantially close around thetubing30. In some embodiments, theend12 includes aclosure system18. Theclosure system18 can be a tongue and groove system where the tongue is configured to fit within the groove when the sheath is attached to thecatheter hub40. The closure system can also include sidewalls that are forced into contact one with the other. Other configurations are also possible.

Theend12 of the sheath can also include apassageway28 that passes through theend12. Thepassageway28 can be permanent or temporary or can only open in certain positions of thesheath10, such as when the sheath is installed on thecatheter hub40. The passageway can be configured such that thetubing30 passes through thepassageway28. In some configurations, the tubing andpassageway28 and/or end12 can form a firstperipheral seal50 such that thesheath10 sealingly engages the sidewalls of thetubing30, while still allowing the tubing to pass through theend12. Theseal50 can be a water-tight or a near water-tight seal.

Theend14 of the sheath can be sized to accept theneedleless connector20 and form a secondperipheral seal52 along the sides of theneedleless connector20. In some embodiments thesecond seal52 can be formed at or near theconnector end22. Alternatively it may be positioned at other locations along theconnector20. Thesheath10 can also seal theinterface32 between thecatheter hub40 and theneedleless connector20. Aninternal seal54 can also be formed in some configurations between aradially extending portion42 of thecatheter hub40 and theend22 of theneedleless connector20. As shown, theend22 of theneedleless connector20 includes internal male luer threads and anend surface22a.In some embodiments thesheath10 can be positioned between theend surface22aand theradially extending portion42 to create a washer-like seal. Whether theseal54 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 thesheath10 and one or more of thecatheter hub40, theneedleless connector20, and/or thetubing30.

In some embodiments, theneedleless connector20 can be attached to thecatheter hub40 either before or after thesheath10 has been attached to thecatheter hub40. Thus, the needleless connector can be removed and/or replaced without removing thesheath10. In addition, thesheath10 can maintain thecatheter hub40 and a portion of the tubing in an enclosed, protected and sealed state independent of the placement of the needleless connector.

In alternative embodiments, thesheath10 can be made integrally with theneedleless connector20. In this configuration removing the needleless connector would also remove the sheath.

Returning toFIG. 3, it can be seen that in some embodiments thesheath10 has aninternal chamber34. Theinternal chamber34 can enclose a portion of thetubing30 as well as thecatheter hub40. Thesheath end12 can be spaced away from thecatheter hub40 to also enclose a section of thetubing36 adjacent thecatheter hub40. 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, thechamber34 can include a disinfectant, antibacterial, or antimicrobial solution or other material to increase the effectiveness of the barrier. In some embodiments, thesheath10 itself may include or exude a disinfectant, antimicrobial, or antibacterial material.

The length oftubing36 adjacent thecatheter hub40 that is enclosed within thesheath10 can be as long, longer or shorter than the catheter hub itself.

In some embodiments, thesheath10 can be configured to be non-reusable and/or removed by destruction. Removal by destruction can prevent a used and contaminatedsheath10 from being reused. For example, thesheath10 can be configured to break or tear along arelease portion38. Thesheath10 can utilize one or more seams, thin walled sections, tear away sections, etc., or combinations thereof to create therelease portion38. Therelease portion38 can be used to cause thesheath10 to separate from the other components of the catheter system. For example, portions of thesheath10 can be pulled in opposite directions causing therelease portion38 to break or tear and thesheath10 to split apart. Therelease portion38 can extend along a portion of or theentire sheath10.

In some typical uses of a catheter system, theneedleless connector20 is often removed from thecatheter hub40 and replaced with a new needleless connector after a period of time, for example3 days. A sheath can beneficially be added to such a system. Thesheath10 can also be removed and replaced at the same time as theneedleless connector20. For example, thesheath10 can be ripped off the catheter hub, utilizing therelease portion38. 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

Thesheath10 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 ofclaim 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 ofclaim 1, wherein the release portion comprises at least one of a seam, a thin walled section, or a tear away section.

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

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

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

9. The sheath ofclaim 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 ofclaim 11, wherein the first end is configured to be permanently attached to the connector.

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

14. The sheath ofclaim 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 ofclaim 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 ofclaim 16, wherein the first end is configured for sealing engagement with the needleless connector.

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

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

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

23. The system ofclaim 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 ofclaim 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 ofclaim 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 ofclaim 24, wherein damagingly removing the first flexible sheath comprises tearing the first flexible sheath.

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

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