# US 11,109,931 B2 · Multi-layer pre-drape apparatus and process

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- Number: US 11,109,931 B2
- Document ID: US11109931B2
- Status: Granted
- Kind: B2
- Application number: 15/341,173
- Filed: 2016-11-02
- Published: 2017-05-04
- Granted: 2021-09-07
- Earliest claimed: 2015-11-02
- Assignees: Work Fluidics, LLC
- Applicants: Work Fluidics
- Inventors: Kenneth B Trauner; Josef Gorek
- Web page: https://patentgrep.com/patent/US11109931B2

## CPC

- A61B 46/20: specially adapted for patients
- A61B 17/135: inflatable
- A61B 46/00: Surgical drapes
- A61B 46/27: tubular, e.g. for arms or legs (A61B46/13 takes precedence)
- A61B 46/40: {Drape material, e.g. laminates; Manufacture thereof}
- A61B 90/80: Implements for cleaning or washing the skin of surgeons or patients
- A61M 19/00: Local anaesthesia (syringes therefor A61M5/00); Hypothermia (A61M5/42 takes precedence; cooling blood in a bypass of the arterial system A61M1/36)
- A61B 90/40: Apparatus fixed or close to patients specially adapted for providing an aseptic surgical environment
- A61B 2046/201: {for extremities, e.g. having collection pouch}
- A61B 2046/205: {Adhesive drapes}
- A61B 2046/236: {with means for collecting drain fluid, e.g. drain tubes}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- 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)}

## Abstract

A multi-layer pre-drape apparatus is applied to a patient before the patient is moved into the operating room. The multi-layer pre-drape apparatus includes a lower layer with a center aperture and an upper layer that covers the aperture. The multi-layer pre-drape apparatus can be placed on a sterilized area of the patient to maintain the cleanliness of the incision area. Alternatively, the multi-layer pre-drape apparatus can be placed on the patient and sterilization fluid can be applied to the skin of the patient through the aperture. The patient can then be moved into the operating room and the upper layer of the multi-layer pre-drape can be removed to expose the sterilized area of the patient in the aperture. Additional drapes can be added to the pre-drape apparatus.

## Claims

### Claim 1

A multi-layered pre-drape comprising:
a lower layer with an aperture;
a middle layer having a flat section that surrounds the aperture and a folded drape section surrounds the flat section of the middle layer wherein the folded drape section is expandable from a folded configuration into an unfolded configuration that drapes outward;
an upper layer that is a sterile cover that covers the middle layer, the lower layer, and the aperture which are sterile, wherein the upper layer covers the folded drape section and holds the folded drape section in place;
a first adhesive that is configured to secure a lower surface of the lower layer to a patient with a surgical area within the aperture of the lower layer; and
a second adhesive that secures a lower surface of the upper layer to an upper surface of the lower layer and an upper surface of the flat section of the middle layer wherein an adhesive strength of the first adhesive is greater than the second adhesive.

### Claim 2 (depends on 1)

The multi-layered pre-drape of claim 1 wherein an upper surface of the upper layer is not sterile and the lower surface of the upper layer, the first adhesive, the lower layer and the second adhesive are sterile.

### Claim 3 (depends on 1)

The multi-layered pre-drape of claim 1 wherein the upper layer over the aperture is transparent.

### Claim 4 (depends on 1)

The multi-layered pre-drape of claim 1 wherein when the perimeter of the upper layer is opened, the folded sections of the middle layer is unfolded and expanded.

### Claim 5 (depends on 1)

The multi-layered pre-drape of claim 1 further comprising:
a hermetically sealed sterile package wherein the lower layer and the middle layer are hermetically sealed in the hermetically sealed sterile package.