Patent Publication Number: US-7591269-B2

Title: Medical procedure drape

Description:
FIELD OF THE INVENTION 
   This invention relates generally to a method and apparatus for use during a medical procedure and more particularly to a medical procedure drape for use during a medical procedure including colonoscopy, sigmoidoscopy, proctoscopy, with or without biopsy, polypectomy, or endoscopic photography. 
   BACKGROUND AND SUMMARY 
   Colonoscopy is a medical procedure or test whereby a physician or other caregiver uses a fiberoptic device to visually examine a patient&#39;s colon and rectum. Typically, a colonoscopy may be performed to assess the anatomy of the lining of the colon and rectum. A colonoscopy may detect the presence of polyps or other cancerous or precancerous tissue. In addition, information related to other diagnoses such as terminal ileitis or colitis may be ascertained during a colonoscopy. 
   Flexible fiberoptic colonoscopy first appeared as a diagnostic and therapeutic procedure in the mid 1970s. It has become an effective tool for evaluating the colonic mucosa and diagnosing and treating diseases of the large intestine. Screening colonoscopy has become a mainstay of appropriate medical care and the removal of pre-malignant polyps has reduced the incidence of colon cancer. Patients scheduled for colonoscopy engage in a laxative preparation usually done on the day prior to the examination or procedure. The patient may be brought to an outpatient facility and examined by a physician and evaluated by the nursing staff. Pre-operative vital signs are taken and an intravenous site is secured. The patient is moved to the endoscope suite where he is or she is placed in the lateral position, lying on the left side, on a patient cart, bed, or stretcher. Cardiac and pulmonary systems are monitored closely. 
   Typically, the patient is positioned with the patient&#39;s back relatively straight and parallel to the longitudinal direction of the cart and close to the edge with the hips flexed approximately 45°. This places the lower legs in line with the longitudinal axis of the patient cart. The procedure may be completed either under conscious sedation or a general anesthetic. Once the patient is appropriately anesthetized or sedated, blankets are removed and the patient is prepared for the colonoscopy. Once the procedure is completed, the patient is cleansed and removed to another room for recovery. 
   In accordance with one aspect of the present invention, there is provided a medical procedure drape for use during a medical procedure performed on a patient supported by a patient support including a cover and barrier. The cover includes a first portion to superimpose at least a portion of a patient and a second portion to superimpose at least a portion of the patient support, and a barrier, disposed adjacent the cover. The barrier extends above the patient support surface. 
   In another aspect of the invention there is provided a method of reducing contamination of a physician during a medical procedure performed on a patient supported on a patient support. The method includes the steps of providing a cover having a first side and a second side, providing a barrier, coupling the barrier to the patient support, and covering the patient support and the barrier with the cover. 

   
     BRIEF DESCRIPTION OF THE DRAWINGS 
       FIG. 1  is a perspective view of a patient undergoing a colonoscopy performed by a physician using a colonoscope and a medical procedure drape. 
       FIG. 2  is a perspective view of the patient of  FIG. 1 , including the medical procedure drape having a barrier covered with a cover. 
       FIG. 3  is a perspective view of the patient of  FIG. 1 , including another embodiment of the medical procedure drape. 
       FIG. 4  is a plan view of a cover of the present invention. 
       FIG. 5  is a plan view of another embodiment of the cover of the present invention. 
       FIG. 6  is a perspective view of the barrier of the present invention. 
       FIG. 7  is a perspective view of a patient support including the barrier positioned at the patient support. 
       FIG. 8  is a perspective view of the drape of  FIG. 4  positioned on the patient support and the barrier of  FIG. 7 . 
       FIG. 9  is a perspective view of the drape of  FIG. 5  positioned on the patient support and the barrier of  FIG. 7 . 
       FIG. 10  is a perspective view of the barrier of  FIG. 6  in a folded condition. 
       FIG. 11  is a perspective view of the cover of  FIG. 4  in a folded condition located adjacent the barrier of  FIG. 10  and partially enclosed in a package. 
   

   DETAILED DESCRIPTION OF THE DRAWINGS 
   The embodiments of the present invention described below are not intended to be exhaustive or to limit the invention to the precise forms disclosed in the following detailed description. Rather, the embodiments are chosen and described so that others skilled in the art may appreciate and understand the principles and practices of the present invention. 
   Referring now to  FIG. 1 , there is shown a medical procedure drape  8 , including a cover  10  for assisting a physician  12 , endoscopist, or other caregiver, when performing a colonoscopy or other endoscopic procedure on a patient  14 . During the procedure, the patient  14  is anesthetized while lying on a patient supporting device  16 , which may include a bed, cart, or stretcher. The patient supporting device  16  may include a mattress  18  upon which the patient  14  lies. In  FIG. 1 , the patient  14  is shown lying at an angle for ease of illustration. As previously described, the patient would typically lie with the patient&#39;s back longitudinally aligned with the long axis of the patient support device  16 . The endoscopist has removed his right hand from the colonoscope so as to demonstrate the detail of the position of the procedure drape, the barrier, the colonoscope, and the patient. 
   To perform a colonoscopy or other medical procedure using the present invention, the cover  10  is laid upon or superimposes the patient&#39;s legs whereby a portion of the medical cover  10  covers a barrier  20 . The physician  12  inserts a flexible tube  22  of a fiberoptic flexible colonoscope  24  into the patient&#39;s colon. The flexible tube includes fiberoptic cable including an air supply for inflating the colon and a light for examining the mucosa therein. A communication cable  26  is coupled to medical equipment  28  supported by an equipment cart  30 . The medical equipment  28  includes signal processing equipment and other control devices for supplying the camera signal to a video monitor  32 . 
     FIG. 2  is a perspective view of  FIG. 1  including the cover  10 , the barrier  20 , and the mattress  18 . Once the patient is under conscious sedation or general anesthetic, blankets on the patient are removed from the lower portion of the patient, and the cover  10  is applied to the patient. The cover  10  covers the lower portion of the patient and may cover a lower portion of the patient support device  16 . In addition, the barrier  20  seen also in  FIGS. 6 and 7 , is positioned at the patient support. A portion of the barrier  20  is located between the mattress  18  and a deck  34  coupled to a frame  36  of the patient support device  16 . A portion of the cover  10  covers the barrier  20 . The cover  10  may be glued, stitched, adhered, or held at the lines  37  to form a pocket  39  which fits over the barrier  20 . 
   Another portion of the cover is positioned beneath the patient&#39;s left hip  38 . In addition, the cover  10  may include a pocket or holder  40  coupled to the cover  10  which may hold medical procedure devices including tools, swabs, gauze squares, or surgical wipes. 
     FIG. 3  illustrates another embodiment of the medical procedure drape  10 . The portion covering the barrier  20  does not include a preformed pocket to cover the barrier, but instead hangs loosely over the barrier. 
   Referring now to  FIG. 4 , the cover  10  may be formed from a single sheet of material. The material used to form the cover  10  may include a flexible cloth-like material made of disposable or incinerable natural or synthetic fibers, woven fibers, as well as plastic or other synthetic sheeting materials. It is preferred that the material used to make the cover  10  is a substantially liquid impervious or liquid repellent material. 
   The cover  10  may be constructed from a single sheet of material having a generally square or rectangular configuration in which portions of the material are removed. The portions removed define a first portion  42 , also seen in  FIG. 2 , which covers the lower portion of the patient and a portion of the cart. A second portion  44  is formed by removal of material from the substantially rectangular sheet of material to thereby define the second portion  44 . The second portion  44  includes a corner  45  defined by an edge  46  and an edge  47  which intersect to form the corner. The edge  46  and edge  47  define a perimeter edge, which may include a triangular shape, a rectangular shape, or other shape to separate the first portion  42  from the second portion  44 . The first portion  42  may then be located above the patient while the second portion  44  may be located beneath the patient when in use. 
   The second portion  44  is tucked underneath the patient&#39;s left hip  38 , as illustrated in  FIG. 2 . Material removed at a location  48  thereby defines the first portion  42  and the second portion  44 . Once the second portion  44  is placed under the patient&#39;s left hip  38 , the first portion  42  may be positioned to superimpose or lay over the top of the patient&#39;s right thigh, leg and foot. The first portion may be fixed to the patient with an adhesive or adhesive tape which may be attached thereto at a location  49  on the reverse aspect of the drape. 
   The material used to form the cover includes a third portion  50  which may comprise a third, a half or more of the entire sheet of material, which includes a first segment  52 , a second segment  54 , and a third segment  56 . 
   The first segment  52  is formed by cutting a line  60 , or cutline, substantially perpendicular to an edge  62  of the material. The cutline  60  may be formed by cutting the material along the line  60  or it may be formed by providing perforations to the material which may be torn at a later time to create a cutline of a desired length. A second cutline  64  also formed substantially perpendicular to the edge  62  forms the second segment  54  and the third segment  56 . As can be seen in  FIG. 2 , the first segment  52  lies closest to the head end of the patient support device  16 , the second segment  54  lies above or superimposes the barrier  20  and the third segment  56  lies over the edge of the mattress closest to the foot end of the patient supporting device  16 . The second segment  54  is folded to form the pocket  39  and fixed at the lines  37 . 
     FIG. 5  illustrates another embodiment of the cover  10 . In this embodiment, the second segment  54  is not folded or fixed so that a pocket is not formed. 
     FIG. 6  is a perspective view of the barrier  20 . The barrier  20  includes a first member  66  and a second member  68 . Each of the first members  66  and  68  form a substantially flat surface which may be disposed in a substantially perpendicular direction with respect to one another. The first member  66  and the second member  68  are coupled and intersect at a common boundary  70 . In a preferred embodiment of the present invention, the barrier  20  is made of a material, such as a plastic material, which may be formed as illustrated to include the first member  66  being substantially perpendicular to the second member  68 . The boundary  70  may include a living hinge such that the members  66  and  68  may be folded in a stacked relationship upon one another to a collapsed position or folded position to achieve a substantially parallel orientation for storage as illustrated in  FIG. 10 . A fastener  72 , such as adhesive tape, may hold the members in the substantially parallel configuration until needed. 
   As illustrated in  FIG. 7 , the medical procedure drape  8  is initially prepared for use by coupling the barrier  20  to the patient supporting device  16 . The second member  68  is inserted in a gap  74  located between the bottom surface of the mattress  18  and the deck  34 . It is within the scope of the present invention to couple the barrier  20  to the patient support device  16  with other means or methods as would be understood by those skilled in the art. 
   The barrier  20  may also be made of other materials such as wood, fiberboard, or cardboard. In addition, the first member  66  and second member  68  need not be the same. Also, the first member  66  could be coupled to projections coupled substantially perpendicularly to the plane of first member  66 , where the projections are inserted into the gap  74 . In this embodiment, the second member would be absent. 
   Once the barrier  20  is connected to the patient support device  16 , the cover  10  is laid upon the mattress  18  and the barrier  20 . As illustrated in  FIG. 8 , the pocket  39  of the cover  10  of  FIG. 4  is placed over the first member  66  of the barrier  20 . Both the first portion  42  and the second portion  44  lay upon the surface of the mattress  18  while the first segment  52  and the third segment  56  hang downwardly from and generally perpendicular to the surface of the mattress  18 . The second segment  54  is supported and held in an elevated position above the surface of the mattress  18  and covers the barrier  20 . As illustrated in  FIG. 9 , the segment  54  of the cover  10  of  FIG. 5  hangs over the barrier  20 . As previously described when a patient is placed on the mattress  18 , the second portion  44  is disposed underneath the patient&#39;s left hip  38  and the first portion  42  is disposed on top of the patient. The second segment  54  of the material is located above the surface of the mattress  18  due to the extension of the first member  66  of the barrier  20  above the mattress  18 . 
   Returning now to  FIGS. 1 and 2 , the colonoscope may be held by the physician  12  in the physician&#39;s left hand with the camera, light source, air, and water source at right angles to the patient&#39;s cart or supporting surface  16  to the left of the physician. The right hand of the physician is used to control the flexible tube  22 , which may be approximately 160 centimeters long. The scope may lie on the cover  10  at an area  80  disposed between the barrier  20  and the patient&#39;s leg. The barrier  20  thus holds the scope in position at the area  80  whereby the space may accommodate the full length of the endoscope extending towards the foot of the supporting surface and then returning back towards the physician&#39;s right hand which controls the actuation of the device. 
   The colonoscope  24  is manipulated into and through the large intestine of the patient with the operator&#39;s right hand. The barrier  20 , having a portion thereof located above the surface of the mattress  18 , serves a purpose of containing the scope within the area  80  between the barrier  20  and the patient  14 . Consequently, the scope may be prevented from falling off of the patient cart as well as from contacting the physician  12 . The barrier  20  may also allow the patient to be positioned more closely to the edge of the supporting surface so that the physician&#39;s need to lean over or to reach a long distance to manipulate the instrument is reduced or eliminated. By enabling physician control of the instrument through the location of the barrier, the procedure may be completed in a safe and quick manner thereby reducing fatigue. 
   Upon withdrawal of the scope from the patient, the flexible tube  22  may be placed in the area  80 . Once placed in the area  80 , the remainder of the scope is withdrawn, and placed on the cover  10 , thereby reducing or eliminating contamination of the patient support surface. Once the examination is completed, the scope is completely withdrawn and then may be removed from the location of the procedure or procedure field onto a separate table. The patient may then be cleansed and the medical procedure drape removed in such a way that no contamination remains on the patient, the patient supporting device, the endoscopy staff, or the endoscopy suite. The patient is then transferred to a holding area for monitoring until fully recovered. The cover and the barrier may then be folded appropriately to include any waste in the interior of the cover. The cover and barrier  20  may then be disposed of either through incineration or other means. 
   The medical procedure drape may be provided to a hospital or physician as a kit  82 , illustrated in  FIG. 11 . The kit  82  includes the folded barrier  20  of  FIG. 10  and the cover  10 . The cover  10  may be folded and placed next to the barrier  20  or the cover  10  may be wrapped around the folded barrier  20 . The package  84  may also be formed around the barrier/cover combination. A first sheet  86  and a second sheet  88  are bonded or held together by an adhesive to form the package  82 . When required, the kit is opened by removing one sheet from another to allow the barrier/cover combination to be used. 
   While this invention has been described with specific embodiments thereof, alternatives, modifications and variations may be apparent to those skilled in the art. For instance it is within the scope of the present invention to make the cover from more than one piece or sheet of material. In addition, the barrier  20  may be adhered to or fixed to the segment  54  or to the pocket  39  such that when placed at the patient support, the combination cover and barrier cooperate as a single unit for placement. Accordingly, it is intended to embrace all such alternatives, modifications and variations that fall within the spirit and broad scope of this appended claims.