Surgical incise drapes and methods for their application

• US 10,639,118 B2
• Filed: 04/06/2011
• Issued: 05/05/2020
• Est. Priority Date: 04/06/2011
• Status: Active Grant

• Current Assignee: Entrotech, Inc.
• Original Assignee: Entrotech Life Sciences, Inc.
• Inventors: McGuire, Jr., James E.
• Primary Examiner(s): Nelson, Keri J
• Assistant Examiner(s): Lee, Michelle J
• Application Number:
  US13/081,021
• Publication Number:
  US 20120255562A1
• Time in Patent Office: 3,317 Days
• Field of Search: 128849-856, 602 54, 602 57, 523105, 523111
• CPC Class Codes: A61B 2046/205 Adhesive drapes
• CPC Class Codes: A61B 46/00 Surgical drapes
• CPC Class Codes: A61F 13/023 wound covering film layers without a fluid retention layer
• CPC Class Codes: A61F 13/024 the application or handling support layer being removable

Abstract

A surgical incise drape of the invention comprises: an essentially transparent or translucent extensible film having opposite first and second major surfaces and opposite first and second side edges; a pressure-sensitive adhesive adhered to at least a major portion of the first major surface of the extensible film; an extensible carrier removably adhered to the second major surface of the extensible film and extending past the first and second side edges of the extensible film to provide gripping portions for facilitating wrinkle-free application of the drape to a patient; and, optionally, a release liner adhered to the pressure-sensitive adhesive opposite the extensible film. Methods of applying such surgical incise drapes to a surgical site on a patient'"'"'s body are also disclosed.

Claims

1. A surgical incise drape comprising:

an essentially transparent or translucent extensible film having opposite first and second major surfaces and opposite first and second side edges;

a pressure-sensitive adhesive adhered to at least a majority of the first major surface of the extensible film;

an extensible carrier removably adhered to the second major surface of the extensible film and extending past the first and second side edges of the extensible film to provide gripping portions for facilitating wrinkle-free application of the drape to a patient, wherein the extensible carrier continuously extends across the entire second major surface area of the extensible film and is removably adhered to the extensible film at least at the first and second side edges of the extensible film;

optionally, a release liner adhered to the pressure-sensitive adhesive opposite the extensible film; and

at least one rigid tab positioned along each of opposite first and second side edges of the surgical incise drape, wherein the rigid tabs further comprise an outwardly exposed adhesive.

2. The surgical incise drape of claim 1, wherein the at least one rigid tab positioned along each of opposite first and second side edges of the surgical incise drape comprises a series of spaced-apart rigid tabs.

3. The surgical incise drape of claim 2, wherein the series of spaced-apart rigid tabs extend substantially the entire length of the opposite first and second side edges of the surgical incise drape.

4. The surgical incise drape of claim 2, wherein the series of spaced-apart rigid tabs are opaque.

5. A method of applying a surgical incise drape to a surgical site on a patient'"'"'s body, the method comprising steps of:

providing the surgical incise drape of claim 1;

optionally, disinfecting the surgical site on the patient'"'"'s body;

if present, removing the optional release liner adhered to the pressure-sensitive adhesive;

gripping the extensible carrier on at least one of the gripping portions and rigid tabs adjacent first and second side edges of the extensible film;

positioning the surgical incise drape over the surgical site on the patient'"'"'s body with the pressure-sensitive adhesive directed toward the surgical site on the patient'"'"'s body;

applying pressure to the extensible carrier along the surgical incise drape beginning at a point where a surgical incision is to be made on the patient'"'"'s body; and

conformably adhering the surgical incise drape over the patient'"'"'s body using at least one of the gripping portions and rigid tabs.

6. The method of claim 5, further comprising the step of removing the extensible carrier from the extensible film after the surgical incise drape is adhered to the surgical site on the patient'"'"'s body.

7. The surgical incise drape of claim 1, wherein the extensible carrier has a thickness of at least about 15 μ

m.

8. The surgical incise drape of claim 1, wherein the extensible carrier comprises a material having at least about 25% elongation when tested according to ASTM D412.

9. The surgical incise drape of claim 1, wherein the extensible carrier comprises a material having at least about 50% elongation when tested according to ASTM D412.

10. The surgical incise drape of claim 1, wherein the extensible carrier comprises a polyolefin.

11. The surgical incise drape of claim 1, wherein the extensible film is polyurethane-based.

12. The surgical incise drape of claim 1, wherein the extensible film comprises a material having at least about 25% elongation when tested according to ASTM D412.

13. The surgical incise drape of claim 1, wherein the extensible film comprises a material having at least about 50% elongation when tested according to ASTM D412.

14. The surgical incise drape of claim 1, wherein the extensible carrier is essentially transparent or translucent.

15. The surgical incise drape of claim 1, wherein each rigid tab is positioned between the pressure-sensitive adhesive and the release liner.

16. The surgical incise drape of claim 1, wherein the drape comprises the release liner adhered to the pressure-sensitive adhesive opposite the extensible film.

17. The surgical incise drape of claim 1, wherein the extensible carrier is removably adhered such that it is removable in one piece after application of the drape to the patient.

18. The surgical incise drape of claim 1, wherein the pressure-sensitive adhesive is adhered to the entire first major surface of the extensible film.

19. The surgical incise drape of claim 1, wherein the pressure-sensitive adhesive is adhered to the first major surface of the extensible film at a point where a surgical incision is to be made on the patient'"'"'s body.

20. The surgical incise drape of claim 1, wherein the extensible carrier is removably adhered across the entire second major surface of the extensible film.

21. The surgical incise drape of claim 1, wherein the extensible carrier is removably adhered to the extensible film essentially only along its perimeter.