Isolator for use in surgery or as a clean room and method of using the same

• US 4,950,222 A
• Filed: 09/28/1988
• Issued: 08/21/1990
• Est. Priority Date: 04/23/1985
• Status: Expired due to Term

• Current Assignee: Coopersurgical Incorporated (The Cooper Cos., Inc.)
• Original Assignee: Lone Star Medical Products, Inc. (The Cooper Cos., Inc.)
• Inventors: Fields, Charley J., Fowler, James M. Jr., Scott, Frank B.
• Primary Examiner(s): Kamm, William E.
• Application Number:
  US07/251,072
• Time in Patent Office: 692 Days
• Field of Search: 600/21, 128/205.26, 312/1, 312/3, 312/209
• US Class Current: 600/21
• CPC Class Codes: A61B 90/40 Apparatus fixed or close to patients specially adapted for providing an aseptic surgical environment
• CPC Class Codes: A61G 10/005 Isolators, i.e. enclosures generally comprising flexible walls for maintaining a germ-free environment
• CPC Class Codes: A61G 13/108 Means providing sterile air at a surgical operation table or area treatment rooms A61G10/00; instruments or implements for sterile operation A61B90/00; sterilisation of air A61L9/00; purification of air in air-conditioning systems F24F3/16, F24F8/00

Abstract

An isolator and method of using it for providing a contamination-free atmosphere in which a surgical procedure can be performed or equipment that is sensitive to environmental contamination can be assembled. The isolator includes an inflatable bag of flexible material through which filtered air is circulated. For use in surgery, a portion of the lower side is made of an elastic surgical drape material to allow a body member upon which a surgical procedure is to be performed to be pulled into the work space of the bag. A portion of the top side of the bag is made of a relatively stiff, optically transparent, material through which the surgeon or the assembly worker can view the work area. A plurality of open-ended sleeves are attached to the bag through which the hands and arms of the surgeon and his assistants or the worker can extend into the work space.

Claims

1. An isolator for providing a continuously changing contamination-free atmosphere in which a surgical procedure can be performed or equipment that is sensitive to environmental contamination can be assembled, said isolator comprising an inflatable bag having a bottom, side walls, and end walls of flexible, impervious, material, and an upper side of relatively stiff, optically transparent, material forming a window through which the inside of the isolator can be viewed, a plurality of open-ended sleeves attached to the bag through which hands for performing a surgical procedure or assembly can enter the bag, blower means for continuously supplying the bag from one end with a sufficient volume of air to maintain the pressure in the bag above atmospheric pressure and to change the air in the bag at least two times per minute, means for filtering the air before the air enters the bag and exhaust means in the opposite end of the bag to cause the air to flow through the bag from one end to the other end to restrict the flow of air out of the bag sufficiently to maintain the pressure in the bag above atmospheric pressure sufficiently to inflate the bag.

2. The isolator of claim 1 in which a portion of the bottom of the bag is made of surgical drape material for placing over the patient where the incision is to be made during a surgical procedure.

3. The isolator of claim 1 in which the end of the bag in which the exhaust means are located has an opening therein through which surgical instruments and other equipment can be moved into and out of the bag and a flap for restricting the flow of air through the opening when surgical instruments and other equipment are not being moved through the opening but which allows sufficient air to be exhausted to cause air to flow through the bag from end to end.

4. The isolator of claim 3 further provides with an open-ended chamber having an end attached to the end of the bag with the flap positioned to close the opening between the bag and the chamber and a second flap closing the other end of the chamber to form an air lock through which surgical instruments and other equipment can be moved into and out of the bag, said flaps being provided with openings through which air can be exhausted from the bag through the air lock when either or both of the flaps are closed.

5. The isolator of claim 4 in which the top of the air lock includes a section of relatively stiff, optically transparent plastic providing a window through which the instruments and equipment in the air lock can be viewed and in which the air lock is further provided with sleeve means through which the instruments and equipment in the air lock can be handled.

6. The isolator of claim 1 in which the blower means includes a housing having an interior wall that divides the housing into first and second chambers, said first chamber having an opening through which air can enter the first chamber, an air filter located in the opening to filter larger airborne contaminants including larger bacteria, dust particles, and the like from the air entering the first chamber, a blower located in the first chamber to pump air from the first chamber into the second chamber, a plenum in the second chamber into which the air from the blower is discharged, a second filter attached to the plenum to filter the remaining contaminants from the air, said plenum and second filter being spaced from the outside walls of the second chamber so that the pressure in the second chamber will be higher than the pressure in the first chamber to insure any leakage between the chambers will be filtered air flowing from the second to the first chamber, and means connecting the second chamber to the bag.

7. The isolator of claim 1 in which the window is convex in cross-section.

8. The isolator of claim 1 in which the window is V-shaped in cross-section.

9. The isolator of claim 1 further provided with a plurality of sleeve through which the arms and hands of the workers can and move into the work place, each sleeve comprising four triangular panels attached at their base to the bag and attached to each other along the sides to form a sleeve that is rectangular in cross-section.

10. The isolator of claim 1 in which a portion of the bottom of the bag is made of surgical drape material through which an incision is made during a surgical procedure, said surgical drape material being elastic to allow a body member, upon which a surgical procedure is to be performed, to be pulled into the work space through the incision in the drape that is smaller than the member to cause the stretched elastic material to tightly surround the member and reduce the chances of disease organisms entering the work space from the outside.

11. The isolator of claim 1 in which the means supplying the air include a blower, a sterile air duct through which air from the blower is supplied to the interior of the bag at a pressure at least slightly higher than atmospheric pressure, and a sterile filter located in the air duct downstream from the end of the duct to be connected to the blower so that the connection between the sterile air duct and the blower is made upstream from the sterile filter to allow any non-sterile particles or disease organisms that are introduced into the air duct when the connection is made or in the air supplied by the blower to be trapped by the filter before they enter the bag.

12. The isolator of claim 1 in which a plurality of open-ended sleeves are attached to the bag, through which the hands and arms of the workers can extend into the work space, each sleeve having elastic material encircling the sleeve adjacent its outer end to hold the sleeve tightly around an arm extending through the sleeve to reduce the flow of air from the bag between the air and the sleeve and to cause the sleeve to intussuscept as required to allow the arm to move freely into and out of the bag.

13. An isolator for reducing the chances of disease organisms entering the surgical wound of a patient during a surgical procedure, said isolator comprising an inflatable bag having side and end walls of flexible material, a lower side of flexible material, a portion of which is of an elastic surgical drape material in which an incision can be made to allow a body member upon which a surgical procedure is to be performed to be pulled into the work space and substantially isolated from the ambient conditions outside the isolator by pulling the member through the incision in the drape that is smaller than the member to cause the stretched elastic material to tightly surround the member, and an upper side portion of which is of flexible material and a portion of which is of relatively stiff, optically transparent, material through which the surgeon can view the area of the surgery, a plurality of open-ended sleeves attached to the bag through which the surgeon can extend his hands into the bag, and means for supplying the bag continuously with filtered air to inflate the bag to maintain a work space between the drape and the rigid, optically transparent, material in the upper side and exhaust means through which the filtered air can flow out of the bag continuously so that the air is changed continuously.

14. An isolator for reducing the chances of disease organisms entering the surgical wound of a patient during a surgical procedure, said isolator comprising an inflatable bag for positioning over the area of the patient when the surgery is to be performed, said bag having an upper side, a portion of which is of relatively stiff, optically transparent, material through which the surgeon can view the area of the surgery, a plurality of open-ended sleeves attached to the bag through which the surgeon can extend his hands into the bag, a blower, a sterile air duct through which air is supplied to the interior of the bag by the blower, air exhaust means through which air can flow from the bag, and a sterile filter located in the air duct downstream from the end of the duct to be connected to the blower so that the connection between the sterile air duct and the blower is made upstream from the sterile filter to allow any non-sterile particles or disease organisms that are introduced into the air duct when the connection is made or in the air supplied by the blower to be trapped by the filter before they enter the bag.

15. An isolator for reducing the chances of disease organisms entering the surgical wound of a patient during surgical procedure, said isolator comprising an inflatable bag of flexible material, a blower for supplying an air to the bag to inflate the bag, exhaust means through which air can escape from the bag to allow the air supplied by the blower to flow through the bag, means for filtering the air entering the bag, and a plurality of open-ended sleeves attached to the bag, through which the hands and arms of the surgeon and his assistants can extend into the work space, each sleeve having elastic material encircling the sleeve adjacent its outer ends to hold the sleeve tight around an arm extending through the sleeve to reduce the flow of air from the bag between the air and the sleeve and to intussuscept as required to allow the arm to which it is attached to move freely into and out of the bag.

16. An isolator for reducing the chances of disease organisms entering the surgical wound in a body member of a patient during a surgical procedure said isolator comprising an inflatable bag having side and end walls of flexible material, a lower side of flexible material, a portion of which is of a surgical drape material in which an incision can be made to allow a body member upon which a surgical procedure is to be performed to be pulled into the work space through the incision in the drape that is smaller than the member to cause the stretched elastic material to tightly surround the member and protect the body member from the environment outside the work space, and said bag having an upper side, a portion of which is of relatively stiff, optically transparent, material through which the surgeon can view the area of the surgery, a plurality of open-ended sleeves attached to the bag, through which the hands and arms of the surgeon and his assistants can extend into the work space, each sleeve having elastic material encircling the sleeve adjacent its outer ends to hold the sleeve tight around an arm extending through the sleeve to reduce the flow of air from the bag between the arm and the sleeve and to cause the sleeve to intussuscept as required to allow the arm to which it is attached to move freely into and out of the bag, exhaust means through which air can escape from the bag, and means for supplying the bag continuously with a sufficient volume of filtered air to inflate the bag to maintain a work space between the drape and the rigid, optically transparent, material in the upper side, said air supply means including a sterile air duct through which air is supplied to the interior of the bag by a blower and a sterile filter located in the air duct downstream from the end of the duct to be connected to a blower so that the connection between the sterile air duct and a blower is made upstream from the sterile filter to allow any non-sterile particles or disease organisms that are introduced into the air duct when the connection is made or in the air supplied by the blower to be trapped by the filter before they enter the bag.

17. An isolator for reducing the chances of airborne contaminants entering the surgical wound of a patient during a surgical procedure comprising an inflatable bag of flexible, impervious, material with a window in the upper side of relatively stiff, optically transparent, material through which the surgeon can view the area of the surgery, said bag being elongated having end and side walls and an inlet in one end wall, an inlet blower means for supplying the bag continuously through the inlet, means for filtering the air from the blower before the air enters the bag, and exhaust means in the opposite end wall to cause the air to flow through the bag from one end to the other with a pressure drop sufficient to inflate the bag.

18. A method of providing a continuously changing contamination-free atmosphere in which a surgical procedure can be performed by a surgeon comprising the steps of placing on the patient an inflatable bag having a bottom, side walls, and end walls of flexible, impervious, material and an upper side of relatively stiff, optically transparent material forming a window through which the inside of the bag can be viewed by the surgeon, extending the arms of the surgeon into the bag through open-ended sleeve attached to the bag and performing the surgery, continuously supplying the bag from one end with a sufficient volume of air to maintain the pressure in the bag above atmospheric and to change the air in the bag at least two times per minute, filtering the air before the air enters the bag, exhausting the air from the bag through the opposite end from where the air enters the bag, and restricting the flow of air out of the bag sufficiently to maintain sufficient pressure in the bag to keep it inflated.