Sealed sterile catheter dressings

Abstract

Devices and methods are provided for sealing a catheter insertion site to maintain sterility. In one embodiment, a catheter dressing is provided that includes an adhesive plate configured for attachment to the skin of a patient and a flexible sheath that extends proximally from the adhesive plate. The sheath can be capable of longitudinal extension from a compressed to an extended state and can be configured in its extended state to surround an external segment of a catheter implanted in the patient and circumferentially seal to a portion of the external segment at a distance from the adhesive plate. The dressing can also be configured to restrict longitudinal movement of the catheter while at the same time permitting non-longitudinal movement. One-piece rigid or semi-rigid dressing bodies are also disclosed, as are various methods and devices for facilitating removal and or replacement of a catheter dressing.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]This application is a continuation of International Patent Application No. PCT / US2010 / 54427 filed on Oct. 28, 2010 and entitled “SEALED STERILE CATHETER DRESSINGS,” which claims priority to U.S. Provisional Patent Application No. 61 / 255,927 filed on Oct. 29, 2009 and entitled “SEALED STERILE CATHETER DRESSINGS.” Both of these applications are incorporated herein by reference in their entirety.FIELD OF THE INVENTION[0002]The present invention relates to methods and devices for sealing medical devices, and in particular to methods and devices for sealing and maintaining sterility at a catheter insertion site.BACKGROUND OF THE INVENTION[0003]The insertion of a catheter into a body cavity, duct, or vessel to allow drainage, injection of fluids, and / or access by surgical instruments is a common procedure in the practice of medicine. Catheters come in a variety of shapes and forms and can be used for a variety of tasks, including chemotherapy, ...

AI Technical Summary

Benefits of technology

[0008]In one aspect, a catheter dressing is provided that can include an adhesive plate configured for attachment to the skin of a patient and a flexible sheath having a proximal end and a distal end and extending proximally from the adhesive plate. The sheath is capable of longitudinal extension from a compressed to an extended state and configured in its extended state to surround an external segment of a catheter implanted in the patient and circumferentially seal to a portion of the external segment at a distance from the adhesive plate. The sheath can define a sealed chamber around the external segment of the catheter and a portion of the patient. In one embodiment, movement of the catheter with respect to the patient does not disrupt a seal formed between the sheath and the catheter. The sheath can optionally be coupled to the catheter. The sheath can include a splittable seam formed therein and can be capable of being opened along the seam such that the catheter dressing can be removed from a catheter around which the dressing is installed. In one embodiment, the seam can include a non-full-thickness perforation.

[0012]In another aspect, a catheter dressing assembly is provided that can include an adhesive plate configured for attachment to the skin of a patient, a coupling member configured for coupling to an external end of a catheter implanted in the patient, the coupling member having at least one lumen to provide a fluid flow path to or from the catheter, and a flexible sheath extendable between the adhesive plate and the coupling member to surround a longitudinal segment of the catheter. The sheath can include an attachment mechanism for attaching the sheath to the coupling member, such as a friction coupler, a threaded coupler, an inflation coupler, an electromagnetic coupler, and / or an adhesive. In one embodiment, the attachment mechanism can be attached to the adhesive plate. The sheath can also include a stretchable gasket ring at its proximal end for sealing to the coupling member and the coupling member can include an annular groove for receiving the stretchable gasket ring. At least a portion of the sheath can be transparent and the sheath can include an access portal. The dressing assembly can also include an absorbent member disposed within the sheath. The sheath can define a sealed chamber around the end of the catheter and a portion of the patient. In one embodiment, the sealed chamber can be sterile. The sheath can be formed integrally with the coupling member and / or the coupling member can be directly attached to the adhesive plate. In such embodiments, movement of the catheter with respect to the patient does not disrupt a seal formed between the sheath and the coupling member.

[0017]The method can further include moving the catheter with respect to the patient without disrupting a seal formed between the sheath and the catheter or coupling member. The method can also include effecting and maintaining a sterile seal around the insertion site and / or securing at least one of the sheath and the external segment of the catheter to the patient. The method can include moving the catheter with respect to the patient without disrupting a seal formed between the sheath and the coupling member, applying a sterilizing agent to an interior volume of the sheath through an access portal formed in a sidewall of the sheath, and / or applying sterilizing radiation to an internal volume of the sheath. The sterilizing agent can include at least one of an antibiotic solution, an antimicrobial solution, and a sterilization gas. The method can also include removing a sample from the internal volume of the sheath through an access portal formed in a sidewall of the sheath and testing the sample. The method can also include separating the dressing along a non-full-thickness perforation formed in a sidewall of the dressing.

[0020]In one embodiment, movement of the catheter with respect to the patient does not disrupt a seal formed between the sheath and the catheter. The sheath can also include a stretchable gasket ring at its proximal end for sealing to the portion of the external segment of the catheter. The sheath can also include an attachment mechanism, such as a friction coupler, a snap-fit coupler, a threaded coupler, an inflation coupler, an electromagnetic coupler, or an adhesive. The external segment of the catheter can be any of a catheter body, a catheter hub, a MicroCLAVE-type connector, and a Luer-type connector, and can include an annular groove for receiving the stretchable gasket ring. At least a portion of the sheath can be transparent, and an absorbent member can be disposed within the sheath. The sheath can define a sealed chamber around the external segment of the catheter and a portion of the patient and the sealed chamber can be sterile. The sheath can include an access portal and can be formed integrally with the catheter. The assembly can also include a clamp configured to secure at least one of the sheath and the external segment of the catheter to the patient. The clamp can be configured to increase the integrity of a seal formed between the sheath and the external segment of the catheter. The sheath can also include a stretchable gasket ring at its proximal end for sealing to the portion of the external segment of the catheter and the clamp can be configured to apply a compressive force to the gasket ring. In one embodiment, the attachment mechanism is attached to the adhesive plate.

Problems solved by technology

One major problem with intravascular catheterization methods is the risk of infection.

All of these strategies, however, still have the fundamental drawback of working within the mechanical constraints of the “traditional” patch-type covering dressing.

Inflow of contaminants to the catheter insertion site along these open channels is always a possibility with such methods and devices, and therefore true sterility can never be achieved.

In addition, over time, movement of the skin and catheter relative to one another and relative to the dressing can increase the size of the catheter-dressing gap.

Furthermore, these dressings cannot be exposed to water or other liquids as these liquids will flow directly to the catheter-skin insertion site, thereby further contaminating this site.

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