# US 2014/0155868 A1 · Sheath

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- Number: US 2014/0155868 A1
- Document ID: US20140155868A1
- Status: Published application
- Kind: A1
- Application number: 14/131,426
- Filed: 2012-06-27
- Published: 2014-06-05
- Earliest claimed: 2011-07-08
- Assignees: ICU Medical, Inc.
- Inventors: David Nelson; Nicholas Lopez; Alison D. Burcar
- Web page: https://patentgrep.com/patent/US20140155868A1

## CPC

- A61M 39/165: {Shrouds or protectors for aseptically enclosing the connector}
- A61M 39/18: Methods or apparatus for making the connection under sterile conditions, i.e. sterile docking
- A61M 25/0097: {characterised by the hub (tube connectors or tube couplings A61M39/10)}
- Y10T 29/49817: with other than ancillary treating or assembling
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- Y10T: TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION

## 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.

## Claims

### Claim 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.

### Claim 2 (depends on 1)

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.

### Claim 3 (depends on 1)

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.

### Claim 4 (depends on 1)

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

### Claim 5 (depends on 1)

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

### Claim 6 (depends on 1)

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.

### Claim 7 (depends on 1)

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.

### Claim 8 (depends on 1)

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

### Claim 9 (depends on 1)

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

### Claim 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.

### Claim 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.

### Claim 12 (depends on 11)

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

### Claim 13 (depends on 11)

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

### Claim 14 (depends on 11)

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

### Claim 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.

### Claim 16 (depends on 15)

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.

### Claim 17 (depends on 16)

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

### Claim 18 (depends on 15)

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.

### Claim 19 (depends on 15)

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.

### Claim 20 (depends on 15)

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

### Claim 21 (depends on 15)

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

### Claim 22 (depends on 15)

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

### Claim 23 (depends on 15)

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

### Claim 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.

### Claim 25 (depends on 24)

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.

### Claim 26 (depends on 25)

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.

### Claim 27 (depends on 24)

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

### Claim 28 (depends on 24)

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

### Claim 29 (depends on 24)

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