Sterile system for dressing vascular access site

• US 5,344,415 A
• Filed: 06/15/1993
• Issued: 09/06/1994
• Est. Priority Date: 06/15/1993
• Status: Expired due to Term

• Current Assignee: Deroyal Industries Incorporated
• Original Assignee: Deroyal Industries Incorporated
• Inventors: Felice, Margaret M., DeBusk, Janet S.
• Primary Examiner(s): KRUTER, JEROME
• Application Number:
  US08/077,565
• Time in Patent Office: 448 Days
• Field of Search: 604/304, 604/307, 604/308, 602/53, 602/57, 602/56, 602/58
• US Class Current: 604/304
• CPC Class Codes: A61F 13/0206 with absorbent fibrous layers, e.g. woven or non-woven absorbent pads or island dressings
• CPC Class Codes: A61F 13/0226 characterised by the support layer
• CPC Class Codes: A61F 13/0259 characterised by the release liner covering the skin adhering layer
• CPC Class Codes: A61F 13/05 specially adapted for use with sub-pressure or over-pressure therapy, wound drainage or wound irrigation, e.g. for use with negative-pressure wound therapy [NPWT]
• CPC Class Codes: A61F 2013/00412 for use with needles, tubes or catheters
• CPC Class Codes: A61M 2025/0253 where the catheter is attached by straps, bands or the like secured by adhesives
• CPC Class Codes: A61M 25/02 Holding devices, e.g. on the body

Abstract

The specification discloses a sterile system and associated method for dressing vascular access sites in the skin penetrated by needles or catheters. The system includes a sealed container defining a sterile enclosure within which are provided dressing components including a sterile absorbent pad for being adhesively secured over the vascular access site to cover and protect the penetration area and the lead-in portion of the catheter tube, and a sterile adhesive strip for being adhesively secured to the skin of the patient under the tube as it emerges from beneath the pad, and between the skin and the pad along the edges of the pad in opposite directions from the tube exit location. The dressing components cooperate to engage the tube against lateral and longitudinal movement to provide a more secure infusion site. The system as a whole provides a more sterile, reliable and uniform dressing for vascular access sites.

Claims

1. A system for dressing a tubular access site adjacent the skin of a patient penetrated by an invasive medical device such as a catheter tube, said system comprising:

a container defining a sterile, sealed enclosure therein; and

a preformed, sterilized dressing located within said enclosure, said dressing comprising;

a first sterile dressing component comprising an absorbent pad dimensioned to substantially cover the access site and adapted to absorb fluid from adjacent the access site, said absorbent pad having a first surface for being disposed adjacent the site and a second surface for being disposed facing away from the site, a breathable adhesive-backed web disposed adjacent said second surface of said pad and extending out from a marginal edge of said pad for adhesively securing said pad to the skin around the access site, a barrier film disposed adjacent said second surface of said pad intermediate said pad and said web and adapted to limit entry of moisture and bacteria into said pad from the environment while providing a controlled rate of evaporation of fluids from said pad, a substantially non-adherent covering disposed adjacent said first surface of pad to be placed against the skin to limit adherence of said pad to skin tissue or exudate adjacent the site, and a peel-away cover layer covering at least the portion of said adhesive surface of said web extending out from said pad to provide ready exposure of said adhesive surface of said web by peeling said cover away for attachment of said first dressing component to the skin about the access site, wherein when said first component may be placed over the access site such that a portion of said web will overlay the catheter tube and thereby define a catheter exit location at which the catheter tube is engaged between said web and the skin; and

a second sterile dressing component comprising a breathable web having an adhesive surface and a peel-away cover covering said adhesive surface of said web to provide ready exposure of said adhesive surface by peeling said cover away for attachment of said web of said second sterile dressing component to a desired surface, said web of said second dressing component being dimensioned to provide adhesive securement of a first portion of said web to the skin of the user beneath the catheter tube adjacent the catheter exit location and extending out along opposite directions from the exit location, and to provide adhesive securement of a second portion of said web of said second component to said web of the first dressing component along the marginal edge of said web of said first dressing component adjacent the exit location, wherein the catheter tube may be engaged between said web of said first dressing component and said web of said second dressing component so that undesired lateral and longitudinal movement of the tube may be restricted.

2. The system of claim 1, wherein said enclosure comprises a top layer provided by a sterilizable sheet of a transparent plastic material heat sealed along a weld path to a bottom layer provided by a sterilizable sheet of a printable, opaque plastic material.

3. The system of claim 2, wherein said top layer includes an inner surface and said bottom layer includes an inner surface facing the inner surface of the top layer.

4. The system of claim 3, wherein said enclosure is defined between said inner surfaces of said top and bottom layers.

5. The system of claim 1, wherein said first component is separate from said second component.

6. The system of claim 1, further comprising a notch provided on a portion of said web of said second component.

7. The system of claim 1, wherein said second component is an elongate adhesive-backed strip having a V-shaped notch in a marginal edge of said strip about midway along the length of said strip.

8. A system for dressing a tubular access site in the skin of a patient penetrated by a tubular medical device, said system comprising:

a container defining a sterile enclosure;

a first sterile dressing component located within said sterile enclosure, said first sterile dressing component comprising an absorbent pad dimensioned to substantially cover the access site and adapted to absorb fluid from adjacent the access site, said absorbent pad having a first surface for being disposed adjacent the site and a second surface for being disposed facing away from the site, a barrier film disposed adjacent said second surface of said pad and adapted to limit entry of moisture and bacteria into the pad from the environment while providing a controlled rate of evaporation of fluids from said pad, a substantially non-adherent covering disposed adjacent said first surface of said pad to be placed against the skin to limit adherence of said pad to skin tissue or exudate adjacent the site, and a peel-away cover layer covering at least a portion of said adhesive surface of said web extending out from said pad to provide ready exposure of said adhesive surface of said web by peeling said cover away for attachment of said first dressing opponent to the skin about the access site; and

a second sterile dressing opponent located within said sterile enclosure, said second sterile dressing component comprising an adhesive-backed breathable web having a peel-away cover layer releasably adhered to the adhesive surface of said web, said web of said second sterile dressing having a marginal edge with a notch provided therein dimensioned to engagingly receive the tubular medical device therein adjacent the access site.

9. The system of claim 8, wherein said web of said second sterile dressing component comprises an elongate strip of generally uniform width and generally parallel marginal edges running the length thereof with said notch having a generally V-shape and being located about midway between the ends of said strip along one of said marginal edges.

10. A method of dressing a tubular access site adjacent the skin of a patient penetrated by a tubular medical device which comprises:

providing a self-contained system for dressing the tubular access site, the system comprising a container defining a sterile, sealed enclosure therein containing a first sterile dressing component comprising an absorbent pad dimensioned to substantially cover the access site and adapted to absorb fluid from adjacent the access site, said absorbent pad having a first surface for being disposed adjacent the site and a second surface for being disposed facing away from the site, a barrier film disposed adjacent the second surface of the pad and adapted to limit entry of moisture and bacteria into the pad from the environment while providing a controlled rate of evaporation of fluids from the pad, a substantially non-adherent covering disposed adjacent the first surface of the pad to be placed against the skin to limit adherence of the pad to skin tissue and exudate adjacent the site, and a peel-away cover layer covering at least a portion of the adhesive surface of the web extending out from the pad to provide ready exposure of the adhesive surface of the web by peeling the cover away for attachment of the first dressing component to the skin about the access site; and

a second sterile dressing component comprising an adhesive-backed breathable web having a peel-away cover layer releasably adhered to the adhesive surface of the web, the web of the second sterile dressing component having a marginal edge with an indentation dimensioned to engagingly receive the tube therein;

opening the container to gain access to the first and second sterile dressing components within the enclosure;

removing the first sterile dressing component from the enclosure;

peeling away the peel-away cover layer from the first sterile dressing component to expose the adhesive surface of the web of the first sterile dressing component;

adhesively securing the web of the first sterile dressing component to the skin of the patient with the pad pressingly engaged upon the tube at the site of penetration to substantially cover the site and the portion of the medical device penetrating the site with the adhesive surface of the web of the first dressing component generally sealingly encircling the site and pressingly engaging the portion of the tube leading from the penetration site against the skin so that the tube emerges from beneath a marginal edge of the web at a tube exit location and is engaged between the web of the first dressing component and the skin at the tube exit location;

removing the second sterile dressing component from the enclosure;

peeling away the peel-away cover from the second sterile dressing component and adhesively securing a section of a first portion of the web of the second dressing component to the skin of the user beneath the tube adjacent the tube exit location and securing an additional section of the first portion of the web of the second dressing component to the skin out along opposite directions from the tube exit location; and

adhesively securing a second portion of the web of the second dressing component to the web of the first dressing component along a marginal edge of the web of the first dressing component adjacent the tube exit location to engage the tube between the web of the first dressing component and the web of the second dressing component so that undesired lateral and longitudinal movement of the tube is restricted.

11. The method of claim 10, further comprising placing used first and second dressing components within the enclosure of the container after removal of the first and second sterile dressing components therefrom and thereafter closing the enclosure to substantially sealably enclose the used first and second dressing components therein for disposal.