Patent Publication Number: US-9839488-B2

Title: Sterility cover for medical device surface

Description:
RELATED APPLICATIONS 
     This application claims the benefit of priority to U.S. Provisional Patent Application Ser. No. 61/991,666 entitled Serially Deliverable Cover For Medical Device Surface, filed May 12, 2014, the disclosure of which is incorporated herein by reference in its entirety. 
    
    
     BACKGROUND 
     Medical devices, instruments, implements and the like are commonly used by doctors, nurses and health care providers generally on multiple patients. Devices such as stethoscopes, blood pressure measurement devices, electrodes and the like are used to make contact with some portion of the surface of multiple patients one after the other without thought for sterilization in advance of use or, if sterilization is immediately available for use, is ignored by the health care provider due to the seemingly low risk of contamination of the device being used. 
     SUMMARY OF INVENTION 
     Health care providers and physicians often see how hospitalization can be harmful to a subject&#39;s health. The number of hospital acquired infections are quite alarming. Health care providers are typically very careful to hand wash their hands between attending to successive patients. Health care providers often isolate patients with very resistant infections and sanitize the room when the infected patient is discharged. Notwithstanding such precautions, a major culprit in spreading infection between successive patients is the stethoscope. Health care providers put it around their necks in close proximity to their own exhaled breath. 
     Stethoscopes physically touch every patient that a health care provider normally sees and rarely is a stethoscope cleaned with alcohol. In a typical day in a hospital every patient is seen by at least 3-4 nurses (due to shift changes), 1-3 physicians (depending on whether a specialist are involved or not), 2-3 nurse&#39;s aids (taking vital signs), and possibly a few respiratory therapists. This number is much higher in teaching hospitals because of exposure to medical students and student nurses. The stethoscope touches one patient up to 10 times a day. This means just by random chance a single patient can actually have contact with a total stranger in another floor of the hospital more than once without ever knowing it. Covers for stethoscopes have been devised but have not been practicable in the mechanisms, if any, for accessibility or ease of use. 
     Although bags or covers have been used for covering stethoscopes such as disclosed in U.S. patent publication no. 20120010517, such prior bags or devices cannot dispose the examination detection head in any given position within the bag and cannot ensure that the detection mechanism or the cable extending from the detection mechanism will remain in the bag in a stable location or otherwise once inserted. 
     In accordance with the invention there is provided a disposable bag  10  for maintaining sterility of a medical instrument  283 , the instrument  283  comprising an elongated cable  280  having a cable length LL and a detection mechanism  39  for engagement with an examination surface of a subject to be examined for a signal generated by the subject through the examination surface, the elongated cable  280  being interconnected to the detection mechanism  39  at a proximal end of the cable for transmitting a signal generated by the detection mechanism  39  to a distal end  280   e  of the cable, 
     wherein the bag  10  comprises: 
     a pair of flexible sheets  50 ,  60  comprised of a polymeric material, the sheets having a thickness through which the detection mechanism  39  can sense the signal generated by the subject when the detection mechanism is held in engagement against the examination surface with one of the sheets  50 ,  60  disposed between the detection mechanism and the examination surface, 
     the pair of sheets being arranged in parallel to each other and sealed along opposing lateral sides  52 ,  62  that extend longitudinally LO from a top end  40  to a bottom end  57 ,  61 , the top end  40  being sealed and the bottom end  57 ,  61  being open such that the sheets form an enclosed interior chamber  55  with an open longitudinal bottom end for insertion of the detection mechanism into and longitudinally LO through the enclosed interior chamber  55  a selected insertion distance from the open bottom end  57 ,  61  toward the sealed top end  40 , 
     one  50  of the pair of sheets being longer longitudinally than the other  60  of the pair sheets forming a flap  59  that extends from the one longer sheet to a longer bottom edge  57  that extends longitudinally beyond a shorter bottom edge  61  of the other of the pair of sheets, 
     the bag  10  having a selected longitudinal length LL relative to the cable length such that upon insertion of the detection mechanism  39  through the enclosed interior chamber  55  along the selected insertion distance, the cable extends longitudinally LO from the detection mechanism  39  through the enclosed interior chamber  55  and further through the open bottom end to at least the longer bottom edge  57  of the one longer sheet  50 , 
     the flap  59  being adapted to be attached  47   h ,  47   p ,  300 ,  304  to at least a portion  280   es  of the cable that extends from the detection mechanism to at least the longer bottom edge  61  such that the detection mechanism is held within the enclosed interior chamber  55  by said attachment  47   h ,  47   p ,  300 ,  304 . 
     The flap  59  can have a layer of adhesive material  300 ,  304  disposed on an interior surface of the flap in a selected two dimensional pattern and the cable has an outside surface  280   es  that is adhesively attachable to the adhesive material, the layer of adhesive material being disposed on the interior surface  59   is  of the flap in an arrangement such that at least a portion of the outside surface  280   es  of the cable that extends to at least the longer bottom edge  61  of the one longer sheet of the bag is manually compressible against at least a portion of the adhesive layer and adhesively attachable thereto. 
     The flap typically has a lateral width W, the adhesive material being disposed on the interior surface  59 IS of the flap  59  in an arrangement such that the adhesive material extends laterally LAT along substantially the entire lateral width W of the flap. 
     A thin sheet or strip of non-adhesive material  302  that is complementary to the selected two dimensional pattern of the adhesive material is typically deposited over and adhered to the layer of adhesive material  300 ,  304 , the thin sheet or strip being adapted to be readily peeled off  302   e  of the adhesive material by hand. 
     The cable can have a hook  47   h  connected  47   m ,  47   c  to the cable  280 , the hook  47   h  including a puncture member  47   p  that is adapted to readily puncture through the flap  59  on application of manual force directing the puncture member  47   p  against the interior surface  59   is  of the flap, the hook  47   h  being connected  47   m ,  47   c  to the cable at a position downstream from the detection mechanism. 
     The pair of sheets can be sealed together between the opposing lateral sides  52 ,  62  and the top and bottom ends along one or more seam lines  34 ,  36 ,  34   a ,  34   b ,  36   b ,  36   c  that are arranged in a pattern that engage and hold the detection mechanism to define the selected insertion distance of the detection mechanism when the detection mechanism is inserted through the open bottom end longitudinally through the enclosed interior chamber  55  toward the top end  40  as far as the detection mechanism can be moved longitudinally. 
     The seam lines are typically arranged in a pattern that engage and hold the detection mechanism to define a maximum distance of longitudinal insertion against travel toward the top end when the detection mechanism is inserted through the enclosed interior and moved toward the top end within the interior as far toward the top end as the detection mechanism can be moved. 
     The one or more seam lines are preferably disposed between the sides of the bag in an arrangement that slidably engages the detection mechanism when the detection mechanism is inserted through the enclosed interior and moved toward the top end. 
     The detection mechanism typically has a longest dimension of certain distance, the seam lines being disposed between the sides of the bag a maximum distance apart from each other or from the sides of the bag, that is less than the distance of the longest dimension of the detection mechanism such that the detection mechanism engages against and is held by the seam lines on longitudinal insertion. 
     The seam lines preferably comprise a pair of separate lines formed as mirror images  34 ,  36  of each other around a longitudinal center C of the enclosure, the seam lines being arranged such that the detection mechanism is routed between the seam lines on longitudinal movement of the detection mechanism from the bottom end toward the top end. 
     The seam lines typically form a generally triangular or conical space between the seam lines within the interior of the enclosure. 
     The triangular or conical space is preferably truncated at its top end. 
     The sealed top end is typically attached along a line of perforations  30 ,  32  to a manifold  15 , the perforations enabling manual tearing away of the bag from the manifold. 
     In another aspect of the invention there is provided a In another aspect of the invention there is provided a method of examining a patient with a medical instrument having a cable and detection mechanism as described immediately above wherein the detection mechanism detects a selected signal generated by patient, the method comprising inserting the detection mechanism in a bag as described immediately above, attaching the cord to the layer of adhesive material and examining the patient with the detection mechanism inserted in the bag. 
     In another aspect of the invention there is provided a disposable bag for maintaining sterility of a medical instrument, the instrument comprising an elongated cable having a cable length and a detection mechanism for engagement with an examination surface of a subject to be examined for a signal generated by the subject through the examination surface, the elongated cable being interconnected to the detection mechanism at a proximal end of the cable for transmitting a signal generated by the detection mechanism to a distal end of the cable, 
     wherein the bag comprises: 
     a pair of flexible sheets comprised of a polymeric material, the sheets having a thickness through which the detection mechanism can sense the signal generated by the subject when the detection mechanism is held in engagement against the examination surface with one of the sheets disposed between the detection mechanism and the examination surface, 
     the pair of sheets being arranged in parallel to each other and sealed along opposing lateral sides that extend longitudinally from a top end to a bottom end, the top end being sealed and the bottom end being open such that the sheets form an enclosed interior chamber with an open longitudinal bottom end for insertion of the detection mechanism into and longitudinally through the enclosed interior chamber a selected insertion distance from the open bottom end toward the sealed top end, 
     the pair of sheets each having an interior surface facing each other, one or the other of the interior surfaces having a layer of adhesive material disposed thereon in a selected two dimensional pattern at a longitudinal position between the top and bottom ends such that the adhesive material on an interior surface of one sheet opposes and can make contact with the interior surface of an opposing sheet, 
     the bag having a selected longitudinal length relative to the cable length such that upon insertion of the detection mechanism through the enclosed interior chamber along the selected insertion distance, the cable extends longitudinally from the detection mechanism through the enclosed interior chamber and further through the open bottom end to at least the longer bottom edge of the one longer sheet, 
     the cable having an outside surface that is adhesively attachable to the adhesive material, the layer of adhesive material being disposed on the interior surface of the flap at a selected longitudinal position less than the selected insertion distance in an arrangement such that at least a portion of the outside surface of the cable that extends from the detection mechanism longitudinally to at least the selected longitudinal position of the adhesive material is manually compressible against and adhesively attachable to the adhesive material. 
     The adhesive material of such a bag can be disposed on both of the interior surfaces of the opposing sheets of the bag in the selected two dimensional pattern. 
     The pair of sheets of such a bag are typically sealed together between the opposing lateral sides and the top and bottom ends along one or more seam lines that are arranged in a pattern that engage and hold the detection mechanism to define the selected insertion distance of the detection mechanism when the detection mechanism is inserted through the open bottom end longitudinally through the enclosed interior chamber toward the top end as far as the detection mechanism can be moved longitudinally. 
     Such a bag typically has a lateral width, the adhesive material being disposed on or the or the other or both of the interior surfaces of the opposing sheets in an arrangement such that the adhesive material extends laterally along substantially the entire lateral width. 
     A thin sheet or strip of non-adhesive material that is complementary to the selected two dimensional pattern is preferably deposited over and adhered to the layer of adhesive material, the thin sheet or strip being adapted to be readily peeled off of the adhesive material by hand. 
     The seam lines of such a bag are preferably arranged in a pattern that engage and hold the detection mechanism to define a maximum distance of longitudinal insertion against travel toward the top end when the detection mechanism is inserted through the enclosed interior and moved toward the top end within the interior as far toward the top end as the detection mechanism can be moved. 
     The one or more seam lines of such a bag are preferably disposed between the sides of the bag in an arrangement that slidably engages the detection mechanism when the detection mechanism is inserted through the enclosed interior and moved toward the top end. 
     The detection mechanism of such a bag preferably has a longest dimension of certain distance, the seam lines being disposed between the sides of the bag a maximum distance apart from each other or from the sides of the bag, that is less than the distance of the longest dimension of the detection mechanism such that the detection mechanism engages against and is held by the seam lines on longitudinal insertion. 
     The seam lines of such a bag preferably comprise a pair of separate lines formed as mirror images of each other around a longitudinal center of the enclosure, the seam lines being arranged such that the detection mechanism is routed between the seam lines on longitudinal movement of the detection mechanism from the bottom end toward the top end. 
     The seam lines typically form a generally triangular or conical space between the seam lines within the interior of the enclosure. 
     The triangular or conical space is preferably truncated at its top end. 
     The sealed top end of such a bag can be attached along a line of perforations to a manifold, the perforations enabling manual tearing away of the bag from the manifold. 
     In another aspect of the invention there is provided a method of examining a patient with a medical instrument having a cable and detection mechanism as described immediately above wherein the detection mechanism detects a selected signal generated by patient, the method comprising inserting the detection mechanism in a bag as described immediately above, attaching the cord to the layer of adhesive material and examining the patient with the detection mechanism inserted in the bag. 
     In another aspect of the invention there is provided a disposable bag for maintaining sterility of a medical instrument, the instrument comprising an elongated cable having a cable length and a detection mechanism for engagement with an examination surface of a subject to be examined for a signal generated by the subject through the examination surface, the elongated cable being interconnected to the detection mechanism at a proximal end of the cable for transmitting a signal generated by the detection mechanism to a distal end of the cable, 
     wherein the bag comprises: 
     a pair of flexible sheets comprised of a polymeric material, the sheets having a thickness through which the detection mechanism can sense the signal generated by the subject when the detection mechanism is held in engagement against the examination surface with one of the sheets disposed between the detection mechanism and the examination surface, 
     the pair of sheets being arranged in parallel to each other and sealed along opposing lateral sides that extend longitudinally from a top end to a bottom end, the top end being sealed and the bottom end being open such that the sheets form an enclosed interior chamber with an open longitudinal bottom end for insertion of the detection mechanism into and longitudinally through the enclosed interior chamber a selected insertion distance from the open bottom end toward the sealed top end, 
     one of the pair of sheets being longer longitudinally than the other of the pair sheets forming a flap that extends from the one longer sheet to a longer bottom edge that extends longitudinally beyond a shorter bottom edge of the other of the pair of sheets, 
     the bag having a selected longitudinal length relative to the cable length such that upon insertion of the detection mechanism through the enclosed interior chamber along the selected insertion distance, the cable extends longitudinally from the detection mechanism through the enclosed interior chamber and further through the open bottom end to at least the longer bottom edge of the one longer sheet, 
     wherein the flap has a layer of adhesive material disposed on an interior surface of the flap in a selected two dimensional pattern and the cable has an outside surface that is adhesively attachable to the adhesive material, the layer of adhesive material being disposed on the interior surface of the flap in an arrangement such that at least a portion of the outside surface of the cable that extends to at least the longer bottom edge of the one longer sheet of the bag is manually compressible against at least a portion of the adhesive layer and adhesively attachable thereto. 
     The flap of such a bag typically has a lateral width, the adhesive material being disposed on the interior surface of the flap in an arrangement such that the adhesive material extends laterally along substantially the entire lateral width of the flap. 
     A thin sheet or strip of non-adhesive material that is complementary to the selected two dimensional pattern is preferably deposited over and adhered to the layer of adhesive material, the thin sheet or strip being adapted to be readily peeled off of the adhesive material by hand. 
     The pair of sheets of such a bag are typically sealed together between the opposing lateral sides and the top and bottom ends along one or more seam lines that are arranged in a pattern that engage and hold the detection mechanism to define the selected insertion distance of the detection mechanism when the detection mechanism is inserted through the open bottom end longitudinally through the enclosed interior chamber toward the top end as far as the detection mechanism can be moved longitudinally. 
     The seam lines of such a bag are preferably arranged in a pattern that engage and hold the detection mechanism to define a maximum distance of longitudinal insertion against travel toward the top end when the detection mechanism is inserted through the enclosed interior and moved toward the top end within the interior as far toward the top end as the detection mechanism can be moved. 
     The one or more seam lines of such a bag are preferably disposed between the sides of the bag in an arrangement that slidably engages the detection mechanism when the detection mechanism is inserted through the enclosed interior and moved toward the top end. 
     The detection mechanism preferably has a longest dimension of certain distance, the seam lines being disposed between the sides of the bag a maximum distance apart from each other or from the sides of the bag, that is less than the distance of the longest dimension of the detection mechanism such that the detection mechanism engages against and is held by the seam lines on longitudinal insertion. 
     The seam lines of such a bag preferably comprise a pair of separate lines formed as mirror images of each other around a longitudinal center of the enclosure, the seam lines being arranged such that the detection mechanism is routed between the seam lines on longitudinal movement of the detection mechanism from the bottom end toward the top end. 
     The seam lines preferably form a generally triangular or conical space between the seam lines within the interior of the enclosure. 
     The triangular or conical space is preferably truncated at its top end. 
     The sealed top end is typically attached along a line of perforations to a manifold, the perforations enabling manual tearing away of the bag from the manifold. 
     In another aspect of the invention there is provided a method of examining a patient with a medical instrument having a cable and detection mechanism as described immediately above wherein the detection mechanism detects a selected signal generated by patient, the method comprising inserting the detection mechanism in a bag as described immediately above, attaching the cord to the layer of adhesive material and examining the patient with the detection mechanism inserted in the bag. 
     The present invention also provides a collection of enclosed bags sequentially arranged in a stack, one-next-to-each-other commonly attached to a support that can be readily hung on a rail or other stationary support in an examination room. Each individual bag preferably comprises two opposing sheets attached along two opposing continuous edges of polymer material and attached at one closed end to successive manifold portions of plastic material which in turn are attached to the support. 
     The present invention provides an apparatus and method for preventing contact between the ambient environment and/or the surface of a living subject (e.g. human being or an animal) and the operative surface of a medical instrument or component thereof that is supposed to be placed in contact with or in close proximity to the surface of the subject. The apparatus of the invention comprises a cover into which the operative surface of the medical instrument such as a stethoscope can be inserted so as to prevent microorganisms, chemicals or other matter that might reside on the surface of the instrument from making contact with the subject. 
     In accordance with the invention there is provided an enclosure for a medical instrument having a detection mechanism for engagement with an examination surface of a subject to be examined for a signal generated by the subject, the enclosure comprising: 
     a pair of flexible sheets having a thickness that renders the sheets transmissive to the signal generated by the subject, 
     the pair of sheets being arranged in parallel to each other and sealed along opposing lateral sides extending longitudinally from a top end to a bottom end, 
     the top end being sealed and the bottom end being open such that the sheets form an enclosed bag having an enclosed interior and an open longitudinal bottom end for insertion of the medical instrument into the enclosed interior, one of the sheets being longer longitudinally than the other of the two sheets such that the open bottom end has a flap extending from the one longer sheet to a long bottom edge that extends beyond a short bottom edge of the other sheet, 
     the pair of sheets being sealed together between the opposing lateral sides and the top and bottom ends along one or more seam lines that are arranged in a pattern that engage and hold the detection mechanism to define a maximum distance of longitudinal insertion against travel toward the top end when the detection mechanism is inserted through the enclosed interior and moved toward the top end within the interior as far toward the top end as the detection mechanism can be moved. 
     The one or more seam lines are typically disposed between the sides of the bag in an arrangement that slidably engages the detection mechanism when the detection mechanism is inserted through the enclosed interior and moved toward the top end. 
     The detection mechanism typically has a longest dimension of certain distance, the seam lines being disposed between the sides of the bag a maximum distance apart from each other or from the sides of the bag, that is less than the distance of the longest dimension of the detection mechanism such that the detection mechanism engages against and is held by the seam lines. 
     The sealed top end is preferably attached along a line of perforations to a manifold, the perforations enabling manual tearing away of the bag from the manifold. The seam lines can comprise a pair of separate lines formed as mirror images of each other around a longitudinal center of the enclosure. The seam lines are preferably arranged such that the detection mechanism is routed between the seam lines on longitudinal movement of the detection mechanism from the bottom end toward the top end of the enclosure. 
     The seam lines can form a generally triangular or conical space between the seam lines within the interior of the enclosure. Such a triangular or conical space can be truncated at its top end. 
     The detection mechanism has a longest dimension of certain distance and the seam lines can be separated apart from each other around the center of the enclosure a minimum distance that is less than the certain distance of the longest dimension of the detection mechanism. 
     In another aspect of the invention there is provided, a disposable bag for maintaining sterility of a medical instrument, the instrument comprising a detection mechanism for engagement with an examination surface of a subject to be examined for a signal generated by the subject through the examination surface, the detection mechanism having a longest dimension of certain distance, the bag comprising: 
     A pair of flexible sheets comprised of a polymeric material, the sheets having a thickness through which the detection mechanism can sense the signal generated by the subject when the detection mechanism is held in engagement against the examination surface with a sheets disposed between the detection mechanism and the examination surface, 
     the pair of sheets being arranged in parallel to each other and sealed along opposing lateral sides extending longitudinally from a top end to a bottom end, 
     the top end being sealed and the bottom end being open such that the sheets form an enclosed an enclosed interior with an open longitudinal bottom end for insertion of the medical instrument through the bottom end into the enclosed interior, one of the sheets being longer longitudinally than the other of the two sheets such that the open bottom end has a flap extending from the one longer sheet to a long bottom edge that extends beyond a short bottom edge of the other sheet, 
     the pair of sheets being sealed together between the opposing lateral sides and the top and bottom ends along one or more seam lines that are arranged in a pattern that engage and hold the detection mechanism to define a maximum distance of longitudinal travel of the detection mechanism toward the top end when the detection mechanism is inserted through the enclosed interior and moved toward the top end within the interior as far toward the top end as the detection mechanism can be moved longitudinally. 
     In another aspect of the invention there is provided a method of examining a subject having a selected examination surface, the examination being conducted with a detection mechanism that senses a signal generated by the subject through the examination surface on engagement of the detection mechanism against the examination surface, the detection mechanism having a longest dimension of certain distance, the method comprising: 
     selecting a flexible polymeric sheet material that is transmissive to the signal generated by the subject through the examination surface 
     forming an enclosure comprised of a pair of generally parallel arranged sheets of the selected polymeric sheet material by sealing the sheets along opposing lateral sides of the sheets that extend longitudinally from a top end to a bottom end of the enclosure, 
     sealing the top end of the sheets to form a sealed top end of the enclosure and an interior enclosed between the sealed lateral sides and the sealed top end, 
     forming a longitudinal length of one of the sheets to be longer than a longitudinal length of the other of the sheets such that an open bottom end is formed having a flap that extends from the one longer sheet to a bottom edge that extends longitudinally beyond a bottom edge of the other sheet, 
     forming one or more seam lines between the sheets arranged between the lateral sides in a pattern that enables the seam lines to engage and hold the detection mechanism to define a maximum distance of longitudinal insertion against travel toward the top end when the detection mechanism is inserted through the enclosed interior and moved toward the top end within the interior as far toward the top end as the detection mechanism can be moved; 
     inserting the detection mechanism through the open bottom end and moving the detection mechanism longitudinally toward the top end; 
     manually engaging the detection mechanism inserted within the interior against the examination surface of the subject with a polymeric sheet being disposed between the examination surface and the detection mechanism. 
     In such a method the detection mechanism is typically inserted through the open bottom end and fully inserted longitudinally within the interior as far toward the top end as the detection mechanism can be moved. 
     In such a method, multiple enclosures can be formed as a collection of enclosures attached to a holding mechanism, each enclosure being attached at its top end to a manifold by a series of perforations, the perforations enabling manual tearing away of an enclosure from an associated manifold, the method preferably further comprising: 
     manually tearing away a first enclosure from an associated manifold along the perforations and performing an examination with a detection mechanism inserted with the interior of the first torn away enclosure; 
     disposing the first torn away enclosure subsequent to the examination; and, 
     manually tearing away a second enclosure from an associated manifold along the perforations and performing an examination with the detection mechanism inserted with the interior of the second torn away enclosure. 
     In such a method, the detection mechanism can have a longest dimension having a certain distance and the seam lines can be disposed between the sides of the bag a maximum distance apart from each other or from the sides of the bag, that is less than the certain distance of the longest dimension of the detection mechanism such that the detection mechanism engages against and is held by the seam lines. 
     In such a method, the seam lines can be formed as a pair of separate lines formed as mirror images of each other around a longitudinal center of the enclosure. 
    
    
     
       BRIEF DESCRIPTION OF FIGURES 
         FIG. 1  is a top plan view of an individual bag according to the invention; 
         FIG. 2  is a top perspective view of an individual bag according to the invention showing a stethoscope received fully within the bag in an operational position for use on a patient; 
         FIG. 3  is a side isometric view of a stack of successively mounted bags according to the invention mounted or attached to a holder that are readily detachable from a manifold or holder strip that is attached/connected to the holder; 
         FIG. 4  is a top schematic view showing a variety of alternative seam lines that could be used in forming a bag according to the invention. 
         FIG. 5  is a front plan view of an embodiment of the invention showing a hook attached to the top flap of the bag. 
         FIG. 6  is a side view of  FIG. 5 . 
         FIG. 7  is a perspective view of the hook containing collar component shown in  FIG. 5 . 
         FIG. 8  is an enlarged perspective view of the flap portion of the  FIG. 5  device. 
         FIG. 9  is an enlarged perspective view of the flap portion of another embodiment of a bag according to the invention where a flap contains an adhesive. 
         FIG. 10  is a view similar to  FIG. 9  showing a stethoscope inserted into the  FIG. 9  bag with the cable portion of the stethoscope adhered to the adhesive on the flap. 
         FIG. 11  is a perspective view of another embodiment of a bag according to the invention having an adhesive disposed on an inner wall surface of the bag. 
         FIG. 12  is a view similar to  FIG. 11  showing a stethoscope inserted into the  FIG. 11  bag with the cable portion of the stethoscope adhered to the adhesive. 
         FIG. 13  is a perspective view of another embodiment of a bag according to the invention having an adhesive disposed on an upper corner portion of the inner wall surface of the bag. 
         FIG. 14  is a view similar to  FIG. 13  showing a stethoscope inserted into the  FIG. 13  bag with the cable portion of the stethoscope adhered to the adhesive. 
         FIG. 15  is a perspective view of another embodiment of a bag according to the invention having a pair of flaps disposed on an inner wall surface of the bag. 
         FIG. 16  is a view similar to  FIG. 15  showing a stethoscope inserted into the  FIG. 15  bag with the head of the stethoscope engaged by a flap. 
         FIG. 17  is a side view of the  FIG. 15  bag. 
         FIG. 18  is a side view of the  FIG. 16  bag with the stethoscope inserted into the bag and engaged with the flap. 
     
    
    
     DETAILED DESCRIPTION OF INVENTION 
       FIGS. 1, 2  show an individual bag according to the invention comprised of a first upper sheet  60  that is connected along side edges  52 ,  62  and along a top seal strip  202  to an opposing parallel arranged bottom sheet  50 . Each bag is interconnected to a mounting or manifold strip  15  of plastic along a relatively thin line  32  of polymeric material that has a series of perforations  30  extending from one side edge  52  of the connected sheets across the lateral width B of the bags  300  to the other opposing side edge  62 . The line  32  has a sufficient number of perforations  30  such that an individual bag  10  can be readily detached along the line  32  of perforations  30  from the manifold or mounting strip  15  by steadily pulling a bag downwardly DF away from the strip  15  by hand under relatively light manual force. 
     As shown in  FIG. 1 , each bag has a width B, a height E and seams  34 ,  36  formed between the top and bottom sheets  50 ,  60  in an arrangement as shown for example to form a truncated triangle or V or cone at the top end of the interior volume  55 ,  FIG. 1 a   , of the bags  10 . The seams  34 ,  36  that form the triangle or cone at the top enclosed end  40  of the bag  10  (or other stethoscope head receiving configuration such as a curve), serve to slidably engage the circumferential edge  37  of the head  39  of the medical instrument (such as a stethoscope) when the stethoscope head is manually inserted into the interior  55  and pushed longitudinally LO upward within the interior  55  toward the closed end  40 . On further pushing, urging of the head  39  toward the closed end  40 , the circular  37  head is slid along one or the other or both of the seams into a position where the center C 2  of the circle  37  is slid into approximate alignment with the lateral center C of the bag  10 . The head  39  is thus stabilized in position within the interior  55  of the bag  10  on and around the circumference of the head  39 . The head  39  is a device that is capable of detecting select signals, sounds, vibrations and the like generated by a patient&#39;s body such as in a stethoscope instrument  283  that has a cable or signal communication tube  280  interconnected between the sensing head or detector and the hear jacks  280   e  of the instrument  280 . 
     The width B and height E and arrangement of the seams  34 ,  36  are selected relative to the diameter D 1  of the head  37  so that the circumference  37  of the head  39  fits easily within the open end  70  of the distal-most end of a bag  10 , and also fits readily within the interior enclosed space  55  within the bags. The seams  34 ,  36  are also arranged in a configuration, such as the equilateral triangular configuration shown in  FIG. 1 , such that the diameter D 1  head  39  of the inserted device is readily receivable between and by and engageable with the seams  34 ,  36  and is also readily receivable within the space at the top end of the bags that is formed by and between the seams  34 ,  36 . As shown in  FIG. 1 , in a typical embodiment, the width B is between about 3 and 5 inches (e.g. 4 inches), the height E is between about 10 and 14 inches (e.g. 12 inches), the distance A (height of the truncated triangle formed by seams  34 ,  36  is between about 3 and about 5 inches (e.g. about 4 inches). The seams  34 ,  36  are formed at the closed end of the bags  10 . The height E is selected such that when the circumference  37  of the head  39  is fully disposed within the space defined, bordered or enclosed by the seams  34 ,  36 , a substantial length L of the communicating tube  280  component of the stethoscope is also enclosed within the interior  55  of the bag, typically from about 8 to about 15 inches in length of communication tubing. 
     As shown in schematic in  FIG. 4 , the seam line or lines of a bag  10   a  can comprise a single seam line  34   a  disposed at an angle A relative to the longitude of the bag  10   a , the seam line  34   a  acting to capture and hold the head  39  of the instrument between the line  34   a  and the side  62   a . Alternatively the seam lines can comprise a pair of opposing seam lines  34   b ,  36   b  that are curved in part or curvilinear, the lines  34   a ,  36   a  shown as being mirror images of each other around center line C. Also alternatively, the seam lines can comprise a line  36   c  that is curved or curvilinear which can capture the head  39  between the line  36   c  and the side or edge  52   a . In each embodiment, the head  39  of the instrument has a longest dimension having a length D 1  that is larger than the distance G between the longitudinally top-most point of the seam line or lines and the next closest seam or seal or the seal side  52   a  or  62   a  of the bag  10   a . In each embodiment, the seam line or lines have at least a portion of their contour that is disposed at an angle of between 1 and 89 degrees relative to the longitude of the bag such that when the head  39  is moved manually in the longitudinal direction from the bottom  57  toward the top end  40   a  the circumference  37  of the instrument will slidably engage the angled portion of the seam lines and be guided between the seam lines  34   b ,  36   b  or between a seam line  34   a  or  34   c  and a side  62   a ,  52   a.    
     As can be readily imagined, one of the sealed sides or edges,  52 ,  62  of a bag  10  is typically formed in the fabrication process by application of between between an upper  50  and lower  60  sheet, the other sealed side or edge being formed by simply folding a single sheet of flexible polymeric material over onto itself. 
     As shown in  FIG. 2 , the perforated seam or separation line  32  is spaced slightly upstream beyond the top sealed edge  40  of the bag  10  by a top end seam  32   f  such that when bag  10  is separated from bag  10   a ,  FIG. 2 , the top edge  40  of bag  10  is fully sealed or closed along its top edge  40  by a seam  202 . 
     Because the two opposing sheets  50 ,  60  are typically adhered to each other by electrostatic, moisture or other forces, sheet  50  is formed to have a longer length than sheet  60 , the two sheets  50 ,  60  being attached to each other in an arrangement where the end  57  of sheet  50  extends longitudinally beyond the end  61  of sheet  60  leaving a short-in-length end flap  59  to sheet  50  extending beyond the terminal edge  61  of sheet  60 . The flap  59  enables ready separation of the two sheets  50 ,  60  along the width B of the flap  59  by hand thus enabling the user to readily grab/engage the flap  59  with two fingers and separate the bottom sheet  50  from the top sheet  60  to create an aperture between the terminal edge  61  and the terminal flap  57  readily enabling the medical instrument to be quickly and easily inserted into the interior space  55  of the otherwise sealed bag. 
       FIG. 3  illustrates a collection of individual bags  300 , each separately comprising a connector strip  15 , closed end strip  202  and pair of opposing sheets  50 ,  60 , the multiplicity of bags being arranged in a stacked format, one bag next to the other in parallel stacked sequential arrangement. The stack of the plurality of bags  300  are all attached by conventional means to a holder  250  that is connected to the top connector strips  15  of the bags  300 . The connector or support  250  is provided with a hanger mechanism  260  such that the can be mounted on a hook, nail or other supporting structure. Also as shown in  FIGS. 1, 2 , a small aperture  17  is provided at about the center of the width of the manifold  15  and seam  202  for alternatively mounting the collection of bags  300  on a nail or rod. 
     The apparatus is preferably provided to a user in the format of a plurality of bags that are attached to a common support, rail, hanger, bar or the like (hereinafter individually and collectively referred to as a “support”) and are separable from the support by pulling an individual bag attached to the support with relatively minor manual pulling force away from the support. The system typically comprises a support  250  to which is attached a series of flattened plastic bags arranged in a sequentially stacked one-next-to-each-other arrangement. The last bag on the outside of the stack is arranged such that a closed or sealed end of the bag is tearably attached to a manifold or mount  15  that is typically attached to a support  250  that holds the entire stack together as and in an arrangement as a stack. The sealed end  202  of an individual bag  10  is readily detachably attached to the mount or manifold portion of plastic material  15  via a series of perforations  30  extending from one side  52  of a bag to another side  62  of the bag at the terminal edge  32  of the closed  202  end of a bag  10 . When the last outside-most bag in the series of bags in the stack is torn away from and detached from a manifold strip  15  of plastic, the next bag in the stack is immediately visually and manually accessible to be detached from the next manifold portion of plastic in the stack in the same manner that the previous outside-most bag had been detached. 
     Each bag  10  is held in a stationary position by virtue of the mount/manifold portion  15  of the apparatus being attached or secured to the support or holder  250  which itself is typically mounted via a handle  260  or other equivalent mechanism to a stationary hook, nail, rod or the like which is attached to a stationary structure such as a structural wall or item of furniture or hospital equipment that is stationarily positioned within a room where the bags  10  of the invention would be normally used by a health provider using the medical equipment to be inserted in a bag  10 . With the entire stack of bags being stationarily secured to a wall or other mount, the user can manually engage and exert a downward pulling force DF by hand on the sheets  50 ,  60  of an individual bag  10  and effect a tearing away of a bag  10  along the perforations line/curve  32  to separate the sealed seam  202  and thus an entire bag from the mount/manifold  15 . 
     Most preferably the series of bags in the stack  300  that are attached to the support  250  are all constructed and arranged such that an aperture is disposed in about the lateral center or middle of the mount/manifold  15 . 
     Each bag in the stack typically comprises two generally square or rectangular sheets  50 ,  60  of thin flexible polymeric material that are arranged in parallel one on top of the other and sealably attached to each other along their side edges  52 ,  62  and further attached to each other along their top sealed edges via a widened seam  202 . The bottom edges  57 ,  61  of the two sheets  50 ,  60  that comprise an individual bag  10  are typically not sealed to each other thus forming an opening  70  along the bottom edge  61  of the square or rectangular assembly of the two parallel sheets that are attached to each other along their top and side edges. 
     One of the two parallel one-on-top-of-the-other sheets  50  is preferably longer in length than the other of the two sheets  60  so that when the top and side edges are sealed, the bottom end or edge  57  of one sheet  50  extends beyond the bottom end or edge  61  of the other sheet  60  thus enabling a user of the bag to readily visually and manually locate and separate the two sheets from each other at the bottom edge of the two sheets thus enabling the bag to be readily opened  70  such that the medical device  39  to be inserted through the opening  70  is facilitated. 
     Each individual bag  10  typically has a generally triangular or conical configuration formed into the structure of the bag by a pair of mirror image seam lines  34 ,  36  arranged to form a truncated at-the-top triangle or cone within the interior  55  of the bag at the top closed end of the bag extending along longitudinal length A of the bag  10  such that when a circular head  37  of a stethoscope  39  is forcibly inserted completely within the interior  55  of a bag toward the top edge  40  of the bag  10 , the circumference  37  of the stethoscope head having a diameter D 1  is lodged between the two seam lines  34 ,  36  that form the truncated triangular or conical interior top or closed end of the bag. As shown in  FIG. 1 , the apex of the triangle or V formed by the seams  34 ,  36  is typically not complete leaving a gap G between the top or terminal apex end of the angled seam lines  34 ,  36 . 
     As shown, the distance G at the top longitudinal end of the truncated V shaped seam lines  34 ,  36  is the minimum spaced apart distance between the seam lines around the center C of the bag. The distance G is less than the distance or length D 1  of the diameter of the instrument head  39  which is the longest dimension of the instrument along any straight line such that the instrument head  39  cannot pass between the seam lines  34 ,  36 . 
     Once the stethoscope head is inserted within the interior  55  of a bag, the head  39  is moved from the open end  70  toward the closed end  40 . In the course of inserting and moving the head  39  longitudinally LO toward the closed end, the circumferential edges  37  engage on or the other or both of the seams  34 ,  36 . On further movement longitudinally LO toward the top end  40 , the head  39  eventually is positioned in the position shown in  FIG. 1  such that the circumference  37  of the head  39  engages the seam lines  34 ,  36  and guides and moves the center C 2  of the head toward the lateral center C of the bag. The angled orientation of the V shaped seam lines relative to the longitude LO of the bag serves to slidably engage the circumferential edges  37  of the catheter head  39  and slidably guide the center of the circular or cylindrical head  39  into a stable position along the latitude LAT of the bag that is in alignment/intersection with the lateral LAT center C of the bag  10 . The seam lines  34 ,  36  are seals or permanently fused portions of and between the two sheets  60 . Such seams  34 ,  36  are formed in a conventional manner via application of heat to the outer surfaces of the sheets  60  while engaged against each other, the heat being applied in local concentration along the length of the desired contour of the line or lines  34 ,  36 . Seam formation is typically carried out using a heat press or other conventional process and apparatus for forming such seam lines. 
     Once the head  39  has been fully inserted longitudinally toward the closed top end  40  of the bag  10  and positioned such that the center C 2  is in approximate alignment with the center C, the health provider or user manually positions the head  39  such that a detection surface DS is placed with pressure by manual force against a complementary surface of a patient or subject to be examined, one of the sheets  50 ,  60  being disposed between the surface of the subject being examined and the detection surface DS of the head  39 . The sensitivity of the detection surface DS is high enough and sensitive enough and the thickness of the sheets  50 ,  60  are selected to be of such a degree or thickness to enable the instrument head and detection surface DS to readily receive and detect the desired information such as electrical signals, sound waves, heat or the like from the surface of the subject that the detection surface DS is capable of detecting and transmitting to through the communication tube  280  of the instrument. 
     Once the user has performed the measurement using the head  39  contained within the bag  10 , the bag  10  that was just used to contain and cover the operative surface DS of the instrument  39  is then removed, discarded and another new bag  10  from the stack  300  is torn off from the support  250  for use with another new patient for another cycle of measurement by the user. Each successive individual patient is thus ensured of not being contacted with the operative surface DS of the device but rather by the outside surface of one or the other of the sheets  50 ,  60  of a new individual bag  10  during each successively performed procedure. 
     In one embodiment the polymeric material comprising the bags comprises a sheet of flexible material having a thickness of typically less than about 500 microns and more typically less than about 100 microns. The sheet material itself typically comprises a woven or punch formed fabric, a paper material or a solid polymeric material comprised of one or more polymers such as polyethylene, polypropylene, polyester or the like. 
     The perforations provided along the attachment seams between a manifold and the closed end of a bag are preferably configured to be of such a size and spaced apart from each other from side to side such that an individual bag can be readily detached from a manifold strip of plastic material by use of a normal pulling force using the hand and arm of a human being. 
     The geometrical area or shape of a sheet  50 ,  60  according to the invention can have any one of an unlimited number of forms such as square, rectangular, triangular, oval or egg-shaped. 
       FIGS. 5-8  show an embodiment of the invention where a hook device  47  comprises a tubular mount  47   m  having a hollow bore  47   c  that is complementary in diameter to the diameter of the cable or signal communication tube  280  of the stethoscope  283  such that the mount  47  fits snugly around the exterior surface  280   es  of the cable  280 . A hook  47   h  is attached to the outer surface of the mount  47   m , the hook having a pointed end or puncture member  47   p  for puncturing through the wall of the flap  59  of the bag  10  and thus attaching the cable  280  of the instrument to the bag  10 . As shown when the hook end  47   p  is manually forced through the flap  59  the bag  10  is longitudinally held in a relatively stationary position relative to the detection or sensing member  39  and the cable  280  such that the flexible bag  10  does not freely move or collapse to the point where the sensing head  39  might fall outside of the interior chamber  55  of the bag. 
       FIGS. 9, 10  show an embodiment of the invention where the inside surface  59   is  of the flap  59  has a layer of adhesive  300  attached to the surface  59   is  in a predetermined two-dimensional pattern such as a rectangle as shown in  FIG. 9  that is large enough to readily engage and attach to a portion of the exterior surface  280   es  of the cable  280 . As shown the adhesive can be applied to the surface  59   is  in any desired pattern including a pattern shown in dashed lines  304  that extends substantially the entire lateral width W of the bag  10  that is transverse to the longitude LO. 
     Preferably a thin sheet or film or strip  302  of flexible non-adhesive material is applied over the exposed surface of the adhesive layer  300 ,  304  to protect the adhesive from attaching to or attracting extraneous materials. The film or strip  302  is provided with a readily manually accessible end or tab  302   e  that a user can readily manually engage and pull on to remove the cover  302  when it is ready to be adhered to the surface  280   es  of the cable or tube component  280  of the instrument  283 . As shown when the adhesive is attached to the surface  280   es  of the cable  280 , the bag  10  is longitudinally held in a relatively stationary position relative to the detection or sensing member  39  and the cable  280  such that the flexible bag  10  does not freely move or collapse to the point where the sensing head  39  might fall outside of the interior chamber  55  of the bag. 
       FIGS. 11, 12  show an embodiment where a layer of adhesive  300   a ,  300   b  is applied to either or both of two opposing inside surfaces  50   is ,  60   is  of the two opposing sheets  50 ,  60  that form the bag  10 . The adhesive  300   a ,  300   b  is applied and disposed in a position and geometrical pattern such as a line or a rectangle as shown in  FIGS. 9, 10  that is positioned such that the inside surfaces  50   is ,  60   is  can be readily manually separated along the areas where the adhesive  300   a ,  300   b  is applied and the head  39  inserted into the chamber or enclosure  55  longitudinally past the position of the adhesive  300   a ,  300   b  into engagement with the seams  34 ,  36  as shown in  FIG. 12 . Once the head  39  is inserted, the exterior surface  280   es  of the cable  280  can be manually engaged with one or the other or both of the adhesive layer  300   a ,  300   b  thus attaching the cable  280  to the inside surfaces  50   is ,  60   is  of one or both of the walls or sheets  50 ,  60  of the bag  10 . Once the cable  280  is so attached to the adhesive  300   a  or  300   b , the, the bag  10  is longitudinally held in a relatively stationary position relative to the detection or sensing member  39  and the cable  280  such that the flexible bag  10  does not freely move or collapse to the point where the sensing head  39  might fall outside of the interior chamber  55  of the bag. 
       FIGS. 13, 14  show an embodiment where a layer of adhesive  300   c  is applied in another geometrical patter in another position on one or the other or both of the inside surfaces  50   is ,  60   is  of the two opposing sheets  50 ,  60  that form the bag  10 . As shown the adhesive layer  300   c  is disposed in a small rectangle at an upper corner of the open bottom end of the bag  10  such that the inside surfaces  50   is ,  60   is  can be readily manually separated along the areas where the adhesive  300   c  is applied and the head  39  inserted into the chamber or enclosure  55  longitudinally past the position of the adhesive  300   c  into engagement with the seams  34 ,  36  as shown in  FIG. 12 . Once the head  39  is inserted, the exterior surface  280   es  of the cable  280  can be manually engaged with the adhesive layer  300   c  thus attaching the cable  280  to one or the other of the inside surfaces  50   is ,  60   is  of one or both of the walls or sheets  50 ,  60  of the bag  10 . Once the cable  280  is so attached to the adhesive  300   c , the bag  10  is longitudinally held in a relatively stationary position relative to the detection or sensing member  39  and the cable  280  such that the flexible bag  10  does not freely move or collapse to the point where the sensing head  39  might fall outside of the interior chamber  55  of the bag. 
       FIGS. 15-18  show another embodiment where a pair of sheets or flaps  400 ,  402  are attached via heat seals  400   s ,  402  at their upper edges to the interior surfaces  50   is ,  60   is  of the two opposing sheets  50 ,  60  of the bag  10 . The flaps  400 ,  402  extend across the width W of the bag  10  and are unattached at their upstream edges  400   e ,  402   e  forming a one way notch  400   n ,  402   n  that receives the lip  391  of the head  39  thus preventing the head  39  from exiting the chamber  55 . In this embodiment there is provided a disposable bag  10  for maintaining sterility of a medical instrument, the instrument comprising an elongated cable  280  and a detection mechanism  39  for engagement with an examination surface of a subject to be examined for a signal generated by the subject through the examination surface, the elongated cable being interconnected to the detection mechanism at a proximal end of the cable for transmitting a signal generated by the detection mechanism to a distal end of the cable wherein the bag comprises: 
     a pair of flexible sheets comprised of a polymeric material, the sheets having a thickness through which the detection mechanism can sense the signal generated by the subject when the detection mechanism is held in engagement against the examination surface with one of the sheets disposed between the detection mechanism and the examination surface, 
     the pair of sheets  50 ,  60  being arranged in parallel to each other and sealed along opposing lateral sides  52 ,  62  that extend longitudinally LO from a top end to a bottom end, the top end being sealed and the bottom end being open such that the sheets form an enclosed interior chamber with an open longitudinal bottom end for insertion of the detection mechanism into and longitudinally through the enclosed interior chamber a selected insertion distance from the open bottom end toward the sealed top end, 
     one or the other of the pair of sheets having a flap sheet sealed at an upper edge of the flap sheet across the width of one or the other or both of the interior surfaces of the pair of sheets, the sealed flap sheets forming a notch that receives a circumferential edge of the detection mechanism to prevent the detection mechanism from travelling longitudinally downstream through the open bottom end of the bag. 
     It is to be understood that the foregoing description is intended to illustrate and not limit the scope of the invention.