Fenestrated transparent catheter securing device and method

• US 5,372,589 A
• Filed: 11/24/1993
• Issued: 12/13/1994
• Est. Priority Date: 11/24/1993
• Status: Expired due to Fees

• Current Assignee: Davis W. Gordon
• Original Assignee: Davis W. Gordon
• Inventors: Davis, W. Gordon
• Primary Examiner(s): Hirsch, Paul J.
• Application Number:
  US08/157,669
• Time in Patent Office: 384 Days
• Field of Search: 604/174, 604/177, 604/180, 604/179, 128/DIG. 26
• US Class Current: 604/180
• CPC Class Codes: A61M 2025/0266 using pads, patches, tapes or the like
• CPC Class Codes: A61M 25/02 Holding devices, e.g. on the body

Abstract

A transparent, self-adhesive film dressing with a special aerating fenestra, is provided for efficiently securing an percutaneous catheter to the skin of the patient, for continual and complete visual inspection of the insertion penetration site and catheter, without encouraging growth of bacteria. The film is configured with an open aperture located directly over and surrounding the insertion penetration site, to provide continual aeration and allow the incision site to remain uncovered and accessible to ambient air, and thus remaining dry, preventing accumulation and maintenance of a warm moist environment, discouraging growth of bacteria, and decreasing relative risk of penetration site infection. The surrounding film is transparent for visual inspection, and is adhesive and large enough to serve as an efficient anchor to prevent accidental dislodgement of the catheter, but is no longer an infection hazard.

Claims

1. A transparent fenestrated device for securing a catheter to a patient without increasing relative risk of infection, consisting of:

a single transparent film for covering a portion of the catheter and a portion of the patient'"'"'s body;

said film comprising transparent adhesive for adhering said film to said catheter and body wherein said film comprises sole means for securing said catheter to said body;

said film shaped to form an open aperture of direct, unobstructed aeration over the skin penetration site of said catheter and said patient'"'"'s surrounding skin; and

said open aperture of direct, unobstructed aeration being large enough to allow said site and skin to remain dry, comprising means for significantly inhibiting growth of bacteria.

2. A device according to claim 1 wherein said aperture is at least 15 millimeters in diameter.

3. A device according to claim 1 wherein said film and said adhesive comprise self-adhesive sterile, substantially transparent plastic film, permeable to moisture vapor but impermeable to liquid water, of a type intended as a covering for wounds and medical dressings.

4. A device according to claim 1 wherein said film and said adhesive further comprise means for securing part of the tubing of said catheter to said body.

5. A device according to claim 1 wherein said film further comprises packaging for handling said film, and wherein said packaging comprises means for visually targeting and positioning said film and aperture over said penetration site while applying said film to said catheter and body.

6. A device according to claim 5 wherein said packaging comprises:

a peel-away protective backing sheet on the adhesive side of said film; and

a peel-away protective top sheet on the non-adhesive side of said film;

said top sheet comprising a stiff-edged peel-away frame and a separately removable, peel-away door; and

comprising means for said door to be peeled away from said frame and non-adhesive side of said film, and for exposing to visibility the top central area of said film including said aperture; and

comprising means for said backing sheet to be peeled away from said adhesive side of said film, for exposing said adhesive coating on the bottom of said film; and

for leaving a stiff edged, non-sticky packaging frame on the non-adhesive side of said film, and a transparent, clear centered, sticky bottomed, film with said open aperture in said central area for targeting visibility.

7. A process for securing a catheter to a patient with transparent film without increasing relative risk of infection, comprising the steps of:

selecting transparent, self-adhesive film for covering a portion of the catheter and a portion of the patient'"'"'s body;

shaping said film to form an open aperture over the skin penetration site of said catheter which provides direct, unobstructed aeration to said site when said film is applied to said catheter and body, for allowing said site and said patient'"'"'s surrounding skin to remain dry wherein said film comprises means for significantly inhibiting growth of bacteria;

aligning and positioning said aperture over and around said penetration site when said film is covering said portion of said catheter and body; and

applying and pressing said self-adhesive film into position onto said catheter and body, wherein said film adheres to said catheter and body and comprises sole means for securing said catheter to said body.

8. A process according to claim 7 further comprising the step of shaping said film to form said open aperture at least 15 millimeters in diameter.

9. A process according to claim 7 further comprising the step of selecting said film to comprise substantial permeability to moisture vapor and impermeability to liquid water.

10. A process according to claim 7 further comprising the step of selecting said film to comprise self-adhesive sterile, substantially transparent plastic film, that is permeable to moisture vapor but impermeable to liquid water, of a type intended as a covering for wounds and medical dressings.

11. A process according to claim 7 further comprising the step of adhering a portion of said self-adhesive film onto a portion of the tubing leading to said catheter comprising means for further securing said catheter.

12. A process according to claim 7 further comprising the step of selecting said film to comprise packaging for said film and the step of using said packaging as means for visual targeting and aligning said aperture over said penetration site during application of said film to said catheter and body.

13. A process according to claim 12 wherein said step of using said packaging as visual targeting means comprises the steps of removing the peel-away protective top door from said transparent film;

removing the peel-away protective backing sheet, exposing the adhesive coating, leaving a stiff edged, transparent, central area of said film, with a sticky bottom and non-sticky top, with said open aperture in said central area;

looking through said transparent central area and open aperture to target said aperture over and around said penetration site as said film is applied;

aligning said film so that said open aperture is directly over and around said site;

applying pressure to said stiff-edged frame so that said transparent film adheres to said catheter and body; and

removing said stiff-edged peel-away protective top cover frame.

14. A device for securing a skin penetrating catheter to a patient without increasing relative risk of infection, consisting of:

a single transparent film for covering part of the catheter and part of the patient'"'"'s body;

a transparent adhesive coating on the body contacting surface of said film for adhering said film to said body and said catheter wherein said film and said adhesive comprise sole means for securing said catheter to said body;

an unobstructed opening in said film over and around the skin penetration site of said catheter, directly aerating said site and the surrounding skin for allowing them to remain dry, comprising means for inhibiting growth of bacteria.

15. A device according to claim 14 wherein said unobstructed opening is not less than 15 millimeters in diameter.

16. A device according to claim 14 wherein said film and said adhesive comprise self-adhesive sterile, substantially transparent plastic film, that is permeable to moisture vapor but impermeable to liquid water, of a type intended as a covering for wounds and medical dressings.

17. A device according to claim 14 wherein said film and said adhesive further comprise means for securing part of the tubing of said catheter to said body.

18. A device according to claim 14 wherein said film and said adhesive further comprise packaging for handling said film, and wherein said packaging comprises means for visually targeting and positioning said film and aperture over said penetration site during application of said film to said catheter and body.

19. A device according to claim 14 wherein said packaging comprises:

a protective backing sheet on the adhesive side of said film; and

a protective top sheet on the non-adhesive side of said film;

said top sheet comprising a stiff-edged frame and a separately removable, peel-away door; and

means for said door to be peeled away from said frame and non-adhesive side of said film, for exposing to visibility the top central area of said film including said aperture; and

means for said backing sheet to be peeled away from said adhesive side of said film, for exposing said adhesive coating on the bottom of said film;

leaving a stiff edged, non-sticky packaging frame on the non-adhesive side of said film, and a transparent, clear centered, sticky bottomed, film with said open aperture in said central area for targeting visibility.