# US 8,739,797 B2 · Surgical draping system

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- Number: US 8,739,797 B2
- Document ID: US8739797B2
- Status: Granted
- Kind: B2
- Application number: 11/538,099
- Filed: 2006-10-03
- Published: 2007-05-10
- Granted: 2014-06-03
- Earliest claimed: 2001-08-28
- Assignees: Bonutti Skeletal Innovations LLC
- Applicants: Peter M. Bonutti
- Inventors: Peter M. Bonutti
- Web page: https://patentgrep.com/patent/US8739797B2

## CPC

- A61B 17/025: {Joint distractors}
- A41D 19/0157: {with luminous or reflective means (protective garments with reflective or luminous safety means A41D13/01)}
- A61B 17/0401: {Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors (A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811)}
- A61B 17/155: {Cutting femur}
- A61B 17/157: {Cutting tibia}
- A61B 17/158: {Cutting patella}
- A61B 17/1666: {for the acetabulum}
- A61B 17/1668: {for the upper femur (A61B17/164 takes precedence)}
- A61B 17/1675: {for the knee}
- A61B 17/1703: {using imaging means, e.g. by X-rays}
- A61B 17/1717: {for applying intramedullary nails or pins}
- A61B 17/1721: {for applying pins along or parallel to the axis of the femoral neck}
- A61B 17/1746: {for the acetabulum}
- A61B 17/1764: {for the knee}
- A61B 17/809: {with bone-penetrating elements, e.g. blades or prongs (bone staples A61B17/0642; intramedullary nails with a plate at an end A61B17/7233)}
- A61B 34/20: Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
- A61B 42/00: Surgical gloves; Finger-stalls specially adapted for surgery; Devices for handling or treatment thereof
- A61B 46/00: Surgical drapes
- A61B 90/36: {Image-producing devices or illumination devices not otherwise provided for}
- A61B 90/40: Apparatus fixed or close to patients specially adapted for providing an aseptic surgical environment
- A61F 2/30767: {Special external or bone-contacting surface, e.g. coating for improving bone ingrowth}
- A61F 2/38: for elbows or knees
- A61F 2/3859: {Femoral components}
- A61F 2/3868: {with sliding tibial bearing}
- A61F 2/3877: {Patellae or trochleae}
- A61F 2/389: {Tibial components (A61F2/3868 takes precedence)}
- A61F 2/461: {of knees}
- A61G 13/0045: {specially adapted for hand or wrist surgeries}
- A61G 13/0054: {specially adapted for back or spinal surgeries}
- A61G 13/0063: {specially adapted for knee surgeries}
- A61G 13/0072: {specially adapted for shoulder surgeries}
- A61G 13/0081: {specially adapted for hip surgeries}
- A61B 17/0487: {Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks (suture anchors A61B17/0401; wound clamps or clips A61B17/08; ligaturing clamps or clips A61B17/122)}
- A61B 17/1604: {Chisels; Rongeurs; Punches; Stamps}
- A61B 34/30: Surgical robots
- A61B 90/30: Devices for illuminating a surgical field, the devices having an interrelation with other surgical devices or with a surgical procedure
- A61B 90/361: {Image-producing devices, e.g. surgical cameras}
- A61B 90/37: {Surgical systems with images on a monitor during operation}
- A61B 2017/00004: {(bio)absorbable, (bio)resorbable or resorptive}
- A61B 2017/00199: {with a console, e.g. a control panel with a display}
- A61B 2017/00477: {Coupling (A61B2017/0046 takes precedence)}
- A61B 2017/00557: {inflatable (A61B2017/22051 takes precedence)}
- A61B 2017/00734: {battery operated}
- A61B 2017/0268: {for the knee}
- A61B 2017/0409: {Instruments for applying suture anchors}
- A61B 2017/0414: {having a suture-receiving opening, e.g. lateral opening}
- A61B 2017/0496: {for tensioning sutures}
- A61B 2034/102: {Modelling of surgical devices, implants or prosthesis}
- A61B 2034/105: {Modelling of the patient, e.g. for ligaments or bones}
- 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 2090/064: {for measuring force, pressure or mechanical tension}
- A61B 2090/309: {using white LEDs}
- A61B 2090/401: {using air flow}
- A61B 2217/005: with suction drainage system
- A61B 2217/007: with irrigation system
- A61F 2/30721: {Accessories}
- A61F 2/30724: {Spacers for centering an implant in a bone cavity, e.g. in a cement-receiving cavity}
- A61F 2/30771: {applied in original prostheses, e.g. holes or grooves}
- A61F 2/34: Acetabular cups
- A61F 2/3872: {Meniscus for implantation between the natural bone surfaces}
- A61F 2/4609: {of acetabular cups}
- A61F 2/4684: {Trial or dummy prostheses}
- A61F 2002/2817: {Bone stimulation by chemical reactions or by osteogenic or biological products for enhancing ossification, e.g. by bone morphogenetic or morphogenic proteins [BMP] or by transforming growth factors [TGF]}
- A61F 2002/2835: {Bone graft implants for filling a bony defect or an endoprosthesis cavity, e.g. by synthetic material or biological material}
- A61F 2002/30079: {magnetic}
- A61F 2002/30326: {differing in height or in length}
- A61F 2002/30331: {made by longitudinally pushing a protrusion into a complementarily-shaped recess, e.g. held by friction fit}
- A61F 2002/30364: {Rotation about the common longitudinal axis}
- A61F 2002/30387: {Dovetail connection}
- A61F 2002/30398: {Sliding}
- A61F 2002/30433: {using additional screws, bolts, dowels, rivets or washers e.g. connecting screws}
- A61F 2002/30507: {using a threaded locking member, e.g. a locking screw or a set screw}
- A61F 2002/30761: {Support means for artificial cartilage, e.g. cartilage defect covering membranes}
- A61F 2002/30883: {dovetail-shaped}
- A61F 2002/30892: {parallel}
- A61F 2002/3092: {having an open-celled or open-pored structure}
- A61F 2002/30934: {Special articulating surfaces}
- A61F 2002/30975: {made of two halves}
- A61F 2002/3401: {with radial apertures, e.g. radial bores for receiving fixation screws}
- A61F 2002/3403: {Polar aperture}
- A61F 2002/3895: {unicompartimental}
- A61F 2002/4631: {the prosthesis being specially adapted for being cemented}
- A61F 2002/4635: {using minimally invasive surgery}
- A61F 2002/4677: {using a guide wire}
- A61F 2210/009: magnetic
- A61F 2220/0025: Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
- A61F 2220/0033: made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
- A61F 2220/0041: using additional screws, bolts, dowels or rivets, e.g. connecting screws
- A61F 2250/0037: differing in height or in length
- A61F 2310/00011: Metals or alloys
- A61F 2310/00017: Iron- or Fe-based alloys, e.g. stainless steel
- A61F 2310/00023: Titanium or titanium-based alloys, e.g. Ti-Ni alloys
- A61F 2310/00029: Cobalt-based alloys, e.g. Co-Cr alloys or Vitallium
- A61F 2310/00131: Tantalum or Ta-based alloys
- A61F 2310/00365: Proteins; Polypeptides; Degradation products thereof
- A61G 13/1245: {Knees, upper or lower legs}
- A61G 13/125: {Ankles or feet}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A41D: OUTERWEAR; PROTECTIVE GARMENTS; ACCESSORIES
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)
- A61G: TRANSPORT, PERSONAL CONVEYANCES OR ACCOMMODATION SPECIALLY ADAPTED FOR PATIENTS OR DISABLED PERSONS (appliances for aiding patients or disabled persons to walk A61H3/00); OPERATING TABLES OR CHAIRS; CHAIRS FOR DENTISTRY; FUNERAL DEVICES (embalming corpses A01N1/00)

## Abstract

A draping system provides a continuous sterile field between a patient incision area and one or more medical practitioners. The draping system has a quick release system incorporated into the drape that enables a medical practitioner to separate from the continuous sterile field without disrupting the sterile field around the practitioner or the patient. The draping system may include an abbreviated practitioner gown, a drain and an integral patient incision area or a flap for extending the continuous sterile field around to one or more additional operating room tables. A modular drape and gown system extends the sterile field beyond the operating table allowing practitioners to couple to the extended field. A tent provides an enclosed sterile field useful in mobile or other non operating room surgical environments. Integral lighting and information displays facilitate field surgical procedures.

## Claims

### Claim 1

An operating room draping system for an operating table having a patient positionable thereon, comprising:
a drape having a first portion sized to cover at least a portion of the patient, a second portion integrally formed as a unitary one piece with said first portion, extendable in a direction away from the patient, and a third portion integrally formed as a unitary one piece with said second portion and configured to be worn by a practitioner, a detaching system located between the second portion and the first portion or the third portion, the detaching system enabling separation of the second portion from the first portion or the third portion, the practitioner thereby being separable from said drape without a requirement to remove said third portion from the practitioner, and without disturbing a sterile field associated with the operating table.

### Claim 2 (depends on 1)

The draping system according to claim 1, wherein the drape includes an integral incision region for at least partially coupling said drape to a patient surgical area wherein a patient incision is made by simultaneously cutting through said integral incision region and at least a portion of the patient.

### Claim 3 (depends on 2)

The draping system according to claim 2, wherein at least a portion of said integral incision region contains an antibiotic or antimicrobial agent.

### Claim 4 (depends on 2)

The draping system according to claim 2, wherein said integral incision region comprises:
a transparent panel for placement of said integral incision region upon the patient surgical area; and
an adhesive attached to said transparent panel for adhesively attaching said transparent panel to the patient surgical area wherein the patient incision is made by simultaneously cutting through said transparent panel and at least a portion of the patient.

### Claim 5 (depends on 2)

The draping system according to claim 2, wherein said integral incision region is disposed inferiorly when the draping system is packed in a folded condition.

### Claim 6 (depends on 1)

The draping system according to claim 1, further comprising a drain for collecting fluids in the second portion.

### Claim 7 (depends on 6)

The draping system according to claim 6, wherein said drain is gravity fed or has active suction.

### Claim 8 (depends on 6)

The draping system according to claim 6, wherein said drain includes a filter for draining fluids while retaining tissue within the drape.

### Claim 9 (depends on 1)

The drape according to claim 1, further including a light integral to said drape for providing illumination during surgery.

### Claim 10 (depends on 9)

The surgical drape according to claim 9 further comprising a fenestration through which surgery is performed and wherein said light illuminates said fenestration.

### Claim 11 (depends on 9)

The surgical drape according to claim 9 wherein said light is comprised within a flexible illuminating panel disposed upon said surgical drape.

### Claim 12 (depends on 11)

The surgical drape according to claim 11 wherein said flexible illuminating panel includes an organic light emitting device and has a sterile surface.

### Claim 13 (depends on 1)

The draping system according to claim 1, wherein the drape further comprises a second integral extension portion extending to a second table, the second integral extension portion configured for extending the continuous sterile field between the practitioner and the operating table to the second table.

### Claim 14 (depends on 13)

The draping system according to claim 13, wherein the drape further comprises a third integral extension portion extending to a second practitioner, the third integral extension portion configured for extending the continuous sterile field between the practitioner and the operating table to the second practitioner.

### Claim 15 (depends on 1)

The draping system according to claim 1, wherein said first portion and said third portion are separable from said second portion by a detaching system.

### Claim 16 (depends on 15)

The draping system of claim 15, wherein the first portion and the second portion integrally formed as a unitary one piece.

### Claim 17 (depends on 1)

The draping system according to claim 1, wherein said second portion provides a substantial portion of the sterile field between the patient and the practitioner's torso.

### Claim 18 (depends on 1)

The draping system according to claim 1, wherein said second portion provides a substantial portion of the sterile field between the patient and the practitioner's head.

### Claim 19 (depends on 1)

The draping system according to claim 1, wherein said second portion provides a substantial portion of the sterile field between the patient and the practitioner's arm.

### Claim 20 (depends on 1)

The draping system according to claim 1, wherein said second portion provides a substantial portion of the sterile field between the patient and the practitioner's hand.

### Claim 21 (depends on 1)

The draping system according to claim 1, wherein said second portion provides a substantial portion of the sterile field between the patient and the practitioner's face.

### Claim 22 (depends on 1)

The draping system according to claim 1, wherein said detaching system comprises a perforation or serration within said drape allowing the practitioner to separate said first portion from said second portion, or said third portion from said second portion, along said perforation.

### Claim 23 (depends on 1)

The draping system according to claim 1, further comprising:
a suspension device for suspending the drape substantially beyond an edge of the operating table independently of the patient and the practitioner when the draping system is unfurled.

### Claim 24 (depends on 1)

The draping system according to claim 1, wherein said at least a portion of the gown is unfurled onto the practitioner without lifting said drape from the patient.

### Claim 25 (depends on 1)

The draping system according to claim 1, wherein the draping system is configured in a folded condition for packaging in one piece.

### Claim 26 (depends on 1)

The draping system according to claim 1, wherein said portion of a gown includes a portion configured for wearing upon at least the practitioner's torso, head, arm, face, or hand.

### Claim 27 (depends on 1)

A method for establishing a continuous sterile field between independent sterile fields in an operating room, the method comprising:
placing the draping system of claim 1 in a first sterile field in a folded condition;
unfurling the draping system to cover at least a portion of a patient in the first sterile field with said first portion;
extending the second portion of the draping system to a second sterile field; and
covering at least portion of a practitioner in a second sterile field with said third portion, whereby the first sterile field is connected to the second sterile field establishing a continuous sterile field.

### Claim 28 (depends on 27)

The method according to claim 27, wherein the first sterile field is an operating table with the patient positioned thereon and the second sterile field is the practitioner and an area occupied by the practitioner.

### Claim 29

A surgical drape system for use by a surgical practitioner in a surgical theatre, the drape comprising:
a first drape configured and dimensioned for covering at least a portion of an operating table having a patient positionable thereon, the first drape establishing a sterile field at and above a height of the operating table; and
a second drape removably attachable to the first drape for extending the sterile field beyond an edge of the operating table, the second drape having a first position in which the extended sterile field includes a descending surface extendable below the height of the operating table substantially down to the floor during surgery and an ascending surface extendable from the bottom portion of the descending surface to about the height of the operating table, the second drape having a second position in which the extended sterile field includes a surface extending above the height of the operating table, the second drape connectable to an object in the surgical theatre to be thereby configured to be moveable from the first position to the second position the ascending surface suspendable at a position substantially beyond an edge of the operating table.

### Claim 30 (depends on 29)

The surgical drape system of claim 29 further comprising a fastening element for removably attaching the second drape to the first drape.

### Claim 31 (depends on 30)

The surgical drape system of claim 30 wherein the fastening element includes at least one of a clamp, a hook and loop fastener, a tie, a button, a hook, a snap, and adhesive.

### Claim 32 (depends on 31)

The surgical drape system of claim 31 wherein the fastening element includes an adhesive.

### Claim 33 (depends on 30)

The surgical drape system of claim 30 wherein the second drape includes a pouch.

### Claim 34 (depends on 33)

The surgical drape system of claim 33 wherein the pouch is present with the second drape in the second position.

### Claim 35 (depends on 30)

The surgical drape system of claim 30 wherein the second drape maintains the sterile field as a surgical implement is moved above and below the operating table.

### Claim 36 (depends on 29)

The draping system of claim 29, wherein the object in the surgical theatre is moveable from a first position to a second position, to thereby move the second drape from the first position into the second position.