WO2011041665A2 - Champ opératoire gonflable stérile - Google Patents

Champ opératoire gonflable stérile Download PDF

Info

Publication number
WO2011041665A2
WO2011041665A2 PCT/US2010/051105 US2010051105W WO2011041665A2 WO 2011041665 A2 WO2011041665 A2 WO 2011041665A2 US 2010051105 W US2010051105 W US 2010051105W WO 2011041665 A2 WO2011041665 A2 WO 2011041665A2
Authority
WO
WIPO (PCT)
Prior art keywords
drape
sterile
inflatable
base
hollow interior
Prior art date
Application number
PCT/US2010/051105
Other languages
English (en)
Other versions
WO2011041665A3 (fr
Inventor
Eric Ross Henderson
Original Assignee
University Of South Florida
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by University Of South Florida filed Critical University Of South Florida
Publication of WO2011041665A2 publication Critical patent/WO2011041665A2/fr
Publication of WO2011041665A3 publication Critical patent/WO2011041665A3/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/40—Apparatus fixed or close to patients specially adapted for providing an aseptic surgical environment
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B46/00—Surgical drapes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00535—Surgical instruments, devices or methods, e.g. tourniquets pneumatically or hydraulically operated
    • A61B2017/00557—Surgical instruments, devices or methods, e.g. tourniquets pneumatically or hydraulically operated inflatable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/40—Apparatus fixed or close to patients specially adapted for providing an aseptic surgical environment
    • A61B2090/401—Apparatus fixed or close to patients specially adapted for providing an aseptic surgical environment using air flow
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/15—Absorbent pads, e.g. sanitary towels, swabs or tampons for external or internal application to the body; Supporting or fastening means therefor; Tampon applicators
    • A61F2013/15008—Absorbent pads, e.g. sanitary towels, swabs or tampons for external or internal application to the body; Supporting or fastening means therefor; Tampon applicators characterized by the use
    • A61F2013/15073—Absorbent pads, e.g. sanitary towels, swabs or tampons for external or internal application to the body; Supporting or fastening means therefor; Tampon applicators characterized by the use as drapes

Definitions

  • This invention relates to surgical drapes. More particularly, it relates to a surgical drape that includes a sterile membrane that is inflated over a surgical site.
  • the novel surgical drape includes a sterile membrane that is adhered in surrounding relation to a surgical site on a patient's body.
  • An expandable housing is attached to or formed integrally with the sterile membrane and purified air is introduced under pressure into a space defined by the sterile membrane and the expandable housing to cause the expandable housing to inflate over the surgical site.
  • At least one viewing portal is formed in the expandable housing to enable a surgeon external to the interior of the expanded housing to see thereinto.
  • Hand and arm portals having interlocks that prevent exterior air from entering into the interior of the expanded housing are also provided so that surgical procedures may be performed.
  • the device is light-in-weight and portable. Accordingly, it has utility in conventional operating rooms, emergency units, as well as in the field where no operating room is available.
  • the novel sterile inflatable drape includes a base having a size and shape adapted to cover a surgical site.
  • the surgical site is defined as the area of the patent that will include an incision and an area contiguous to said incision.
  • a peripheral border surrounds the base.
  • the base and the peripheral border have a first side covered with a releasable adhesive adapted to releasably engage a patient's skin when the base and peripheral border are placed over the surgical site prior to an incision.
  • An expandable housing is mounted to a second side of the border in surrounding relation to the base.
  • a hollow interior is defined by a space between the base and the expandable housing.
  • An air purifier has an outlet connected in fluid communication with the hollow interior and an air pump is in fluid communication with an inlet of the air purifier.
  • the expandable housing expands to a predetermined shape that at least partially encloses the patient when purified air is introduced into the hollow interior.
  • the members of the surgical team are external to the housing when said housing is fully expanded.
  • the housing is made of a transparent material, the members of the surgical team can see inside the housing and no viewing portals are required. However, if the housing is made of a translucent or opaque material, at least one viewing portal formed of a clear material is required.
  • the number, size, shape, and positioning of the viewing portal or portals is not critical to the invention and may be determined by the type of surgery to be performed, the number of members of the surgical team, and the like.
  • a plurality of hand portals are also formed in the sterile inflatable drape.
  • Each hand portal of the plurality of hand portals has an interlock that substantially inhibits unpurified, ambient air from entering into the hollow interior when the hollow interior is expanded by purified air flow thereinto.
  • a sterile instrumentation chamber is formed in the sterile inflatable drape to facilitate introduction of surgical tools into the hollow interior.
  • the sterile instrumentation chamber includes a passage having an interlock for substantially preventing ambient air from entering into the hollow interior when a tool is introduced into the hollow interior.
  • a primary object of the invention is to decrease infection rates for all surgical procedures without incurring the expense of a conventional laminar flow operating room.
  • Another important object is to accomplish the foregoing object with a device that is inexpensive to manufacture, easy to use, and that does not require closure of an operating room.
  • FIG. 1 is a perspective view of the novel drape in its deflated configuration
  • FIG. 2 is a perspective view depicting placement of the novel device prior to its inflation with the inflatable part of the device removed to simplify the drawing;
  • FIG. 3 is a perspective view of the device when positioned as in Fig. 2, said depiction obscuring the part depicted in Fig. 2;
  • FIG. 4 is a schematic of the novel drape in its inflated configuration
  • FIG. 5 is a rendering of the inflatable drape after inflation
  • FIG. 6 is a perspective view of an alternative embodiment of the inflatable surgical drape.
  • Fig. 1 in its deflated configuration. It has a rectangular, boxlike shape in this particular embodiment but other shapes are within the scope of this invention.
  • Peripheral border 12 of drape 10 is covered with a suitable adhesive. As best understood in connection with Fig. 2, this adhesive releasably connects drape 1 0 to a body part of a patient. In the example of Fig. 2, drape 10 is adhered to the area that surrounds a patient's knee, in preparation for a surgical procedure known as a knee arthroplasty. Bed 1 1 supports the patient.
  • a suitable releasable adhesive may also be applied to area 14 that is surrounded by peripheral border 12 to cover the patient's skin that surrounds an incision.
  • the adhesive used in areas 12 and 14 may be covered prior to use by peel and seal strip of the type commonly used on mailing envelopes.
  • Drape 10 is provided in expandable form, having an accordion-like form denoted by the reference numeral 16 in Fig. 1.
  • Flexible, sterile intake hose 18 provides fluid communication between the interior of drape
  • drape 10 allows it to expand as purified air is pumped into it.
  • the knee will be surrounded by such purified air as drape 10 expands.
  • Skin near the incision will be covered by the part of area 14 that is adhered to the skin and is not uncovered by the surgeon's scalpel. Accordingly, the incision and the area contiguous thereto are exposed to purified air only and the areas surrounding those incision- contiguous areas are covered by the part of area 14 that is not opened.
  • FIG. 2 depicts only adhesive-covered border area 12 and area 14 enclosed thereby to simplify the drawing to enabling simple depiction of incision location 20.
  • Fig. 3 depicts deflated drape 10 in perspective view when installed in protecting relation to a patient's knee. Such placement follows appropriate skin preparation.
  • Fig. 4 depicts drape 10 in its inflated configuration. Both the patient and the patient- supporting surface of bed 1 1 are now enclosed within the inflated structure.
  • Intake hose 18 provides fluid communication between source 22 of purified air and interior 24 of inflated drape 10. The pressure of the purified air inflates the structure and maintains its inflated configuration for as long as is needed.
  • the power to air purifier 22 is turned off and structure 10 is folded so that border part 12 and section 14 may be removed from the skin around the incision. Drape 10 is then discarded.
  • Portals 28 may be provided in conventional form, with each portal having a sealed interlock to substantially prevent external air from entering into hollow interior 24 when hands and arms are inserted through said portals.
  • the interlocks could simply be provided in the form of a door formed of two confronting plastic strips. They could also include sleeves with rubber bands that close under their inherent bias when an arm or hand is removed from a sleeve.
  • instrument exchange zone 30 One or more similar interlocks, not depicted, are also provided at box-like instrument exchange zone 30.
  • Box 30 enables members of the surgical team to introduce various sterilized surgical tools, also not depicted, into hollow interior 24 as needed and to retrieve them or move them out of the way as they are no longer needed.
  • Instrument exchange zone 30 is depicted as being in open communication with interior 24 at the foot of bed 1 1 but other positions of said zone 30 are within the scope of this invention.
  • Portal 32 is a drain and is positioned at a lowermost point of the inflated drape. It is connected to a vacuum source through a valve to collect liquid fluids that may flow to the bottom floor of drape 10. Collected blood is delivered to a device such as a Cell Saver® blood salvage device, so that said blood may be transfused to the patient during or after conclusion of the surgery.
  • a device such as a Cell Saver® blood salvage device, so that said blood may be transfused to the patient during or after conclusion of the surgery.
  • Fig. 5 is a perspective view much like that of Fig. 4 but depicting drape 10 having rounded surfaces to provide a more life-like view thereof.
  • the reference numerals in Fig. 5 identify the parts already disclosed in connection with Fig. 4.
  • Fig. 6 discloses a simpler embodiment, perhaps more suitable for field use, that encloses less than the entire body of a patient.
  • This embodiment is inflated by air purifier 22 by means of hose 18 as in the first embodiment but no viewing ports 26 are needed because the drape material is transparent.
  • Hand and arm portals 28 equipped with suitable interlocks are provided in this embodiment, but instrument exchange zone 30 is not.
  • the feet as well as the head and shoulders of the patient may be external to hollow interior 24 in this embodiment. Some leakage will occur around such body parts but the flow of purified air into hollow interior 24 ensures that external air cannot enter into interior 24 through such unsealed points.
  • drape 10 may include a stretcher-like surface pad for the patient to rest upon, immobilized if necessary, thereby providing additional protection from the environment.
  • the resting pad is formed integrally with the drape, with a preselected edge of the pad formed integrally with the drape and the remaining three (3) edges being releasably attachable by well- known fastening means such as hook and loop fasteners, clips, ties, and the like.
  • Drape 10 may be manufactured by modifying the IOBAN® drape made by 3M Corporation. It is applied over a surgical site after skin cleansing has been performed with any acceptable surgical skin preparation such as Betadyne, isopropyl rubbing alcohol, chlorhexadine, and the like. The areas of the patient's body that will not be operated upon are covered with conventional cloth or sterile paper drapes.
  • Drape 10 expands and contours itself to the general shape of the patient and operating surface. It confines the surgical team to a relatively small zone of movement during the surgery. Individual drapes to accommodate different surgical procedures are preferred.
  • the spatial requirements for a total knee replacement procedure may be slightly different from the spatial requirements of a total hip replacement procedure.
  • Embedded plastic tabs of the type used to open mailing envelopes could be incorporated into drape 10 to provide a quick release function. Such tabs would be positioned in the base of the drape that circumscribes the inflatable part thereof so that pulling the tabs would separate the inflatable part of the drape from its non-inflatable base. In the alternative, the base and the inflatable part could be separated from one another by use of a scalpel.
  • Figs. 4 and 5 depict an embodiment including regions where drape material has been perforated so that a user can form an emergency access opening in drape 10 along such perforations so that no tool would be needed to gain access into the area enclosed by the drape if needed on an emergency basis.
  • the dimensions of the drape will vary depending upon the surgical environment and type of surgery performed. In most applications, the drape would extend above the level of the operating table by about four feet (4'). The vertical clearance could be lower in the field, perhaps being positioned only one or two feet above the patient.
  • the shape of the drape also varies depending upon the surgical environment and type of surgery performed. As depicted in Figs. 4 and 5, a cubical shape is preferred for a conventional operating room. Round shapes, pyramidal shapes, and other geometrical shapes are within the scope of this invention.
  • the surface upon which the patient lies is distinct from, but releasably connected to, the adhesive/inflatable surface.
  • the patient is in effect wrapped inside the drape, and the inflatable part covers more of the patient providing some protection from the environment.
  • the novel drape could also be releasably attached at its peripheral edges to helmets or other head gear worn by members of the surgical team.
  • the means of attachment could include several embodiments.
  • a VELCRO® hook and loop fastening member or a magnetic attachment would likely provide the easiest attachment.
  • Each helmet would include a clear face shield.
  • a suitable helmet is manufactured by Stryker Orthopaedics and sold under the name T4® personal protection system).
  • the rectangles above and below surgeon viewing portals 26 could provide adhesive, hook and loop, magnetic, or the like, releasable attachment means to releasably interconnect the helmet and drape 10.
  • Air purification is introduced into the novel drape housing by a device that includes several embodiments. Air purification may be accomplished by multiple means such as air filtration, irradiation, and heating. These purification systems may be portable and may include self-contained power systems such as a battery or gas powered compressor. It may be beneficial to introduce heated air into the enclosure to maintain core body temperature for the patient in cold operating room environments.
  • Drape 10 may be equipped with incandescent, fluorescent or LED lighting where conventional power is available. Chemiluminescent lighting, such as a light stick, will have utility in the field.
  • the drape could also be manufactured with clear regions in the ceiling of the drape with handles to grasp overhead lights, or members of the surgical team could wear headlamps.
  • Drape 10 can be used anywhere a power source to operate an air purifier is available.
  • a self-contained power source could be integrated into the purifier. This would make it ideal for use in developing nations where air quality in an operating room may be poor.
  • a self- contained power source would also have utility in portable military or first responder medical units, or in any open field where conventional power sources are not available.
  • Drape 10 has utility in connection with any open surgical procedures where direct visualization of the skin surrounding an incision is not required. Cosmetic or 'plastic' surgical procedures requiring reorientation of portions of skin in order to change the surround skin's appearance would be one of those procedures.
  • This device is particularly beneficial in connection with orthopedic joint replacement and orthopedic trauma surgery.
  • the novel device provides a less expensive and more effective alternative to laminar flow technology.

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  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pathology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Surgical Instruments (AREA)

Abstract

L'invention porte sur un champ opératoire gonflable stérile qui comprend une base ayant une dimension et une forme adaptées pour recouvrir un site chirurgical. Une bordure périphérique entoure la base. La base et la bordure périphérique ont un premier côté recouvert d'un adhésif décollable apte à venir en prise de manière décollable avec la peau d'un patient lorsque la base et la bordure périphérique sont placées sur le site chirurgical avant une incision. Un boîtier extensible est monté sur un second côté de la bordure de façon à entourer la base et un intérieur creux est défini par un espace entre la base et le boîtier extensible. Un purificateur d'air ayant une sortie est relié en communication fluidique avec l'intérieur creux et une pompe à air est en communication fluidique avec une entrée du purificateur d'air. Le boîtier extensible s'étend sous une forme prédéterminée qui enferme au moins partiellement un patient lorsque de l'air purifié est introduit dans l'espace creux.
PCT/US2010/051105 2009-10-01 2010-10-01 Champ opératoire gonflable stérile WO2011041665A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US24779009P 2009-10-01 2009-10-01
US61/247,790 2009-10-01

Publications (2)

Publication Number Publication Date
WO2011041665A2 true WO2011041665A2 (fr) 2011-04-07
WO2011041665A3 WO2011041665A3 (fr) 2011-07-28

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PCT/US2010/051105 WO2011041665A2 (fr) 2009-10-01 2010-10-01 Champ opératoire gonflable stérile

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102014111354A1 (de) * 2014-08-08 2016-02-25 Karl Storz Gmbh & Co. Kg Sterilhülle für ein medizinisches Beobachtungsinstrument sowie Verfahren zum Betreiben eines medizinischen Beobachtungsinstruments
WO2018014003A1 (fr) * 2016-07-15 2018-01-18 Surgibox Inc. Système ultraportable pour l'isolation peropératoire et la régulation d'environnements de sites chirurgicaux

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5809788A (en) * 1996-03-05 1998-09-22 O.R. Solutions, Inc. Surgical drape for use in forming and collecting surgical slush
US20040170836A1 (en) * 2003-01-07 2004-09-02 The Procter & Gamble Company Hollow fiber fabrics
US20080041399A1 (en) * 2004-03-24 2008-02-21 Hans Rudolf Kriek Sterile Enclosures
US20080047567A1 (en) * 2001-08-28 2008-02-28 Bonutti Peter M Surgical draping system
US20080216844A1 (en) * 2006-11-24 2008-09-11 Cheryl Olfert Sterile draping for the bore of a medical imaging system

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5809788A (en) * 1996-03-05 1998-09-22 O.R. Solutions, Inc. Surgical drape for use in forming and collecting surgical slush
US20080047567A1 (en) * 2001-08-28 2008-02-28 Bonutti Peter M Surgical draping system
US20040170836A1 (en) * 2003-01-07 2004-09-02 The Procter & Gamble Company Hollow fiber fabrics
US20080041399A1 (en) * 2004-03-24 2008-02-21 Hans Rudolf Kriek Sterile Enclosures
US20080216844A1 (en) * 2006-11-24 2008-09-11 Cheryl Olfert Sterile draping for the bore of a medical imaging system

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102014111354A1 (de) * 2014-08-08 2016-02-25 Karl Storz Gmbh & Co. Kg Sterilhülle für ein medizinisches Beobachtungsinstrument sowie Verfahren zum Betreiben eines medizinischen Beobachtungsinstruments
US10383507B2 (en) 2014-08-08 2019-08-20 Karl Storz Se & Co. Kg Sterile sleeve for a medical viewing instrument, and method for operating a medical viewing instrument
WO2018014003A1 (fr) * 2016-07-15 2018-01-18 Surgibox Inc. Système ultraportable pour l'isolation peropératoire et la régulation d'environnements de sites chirurgicaux
EP4029469A1 (fr) 2016-07-15 2022-07-20 Surgibox Inc. Système ultraportable pour l'isolation peropératoire et la régulation d'environnements de sites chirurgicaux

Also Published As

Publication number Publication date
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