Abstract:
The present invention is directed to glove inflation apparatuses and methods for donning sterile gloves. The apparatuses includes at least one vacuum chamber that has an opening sized and shaped for receiving a glove and for establishing a fluid-tight seal between the glove and the vacuum chamber. The apparatuses further includes a vacuum pump which is connected to the chamber and a source of compressed gas which is in fluid communication with the glove. The apparatuses further includes a switch that is connected to the pump and the source of compressed gas. The switch has two states. In the first state, the switch permits the pump to evacuate the chamber. In the second state, the switch permits the source of compressed gas to expel the glove from the opening of the chamber. The methods for donning a sterile glove include the steps of securing a cuff portion of a glove onto an opening of a vacuum chamber to establish a fluid-tight seal between the glove and the vacuum chamber, creating a vacuum in the vacuum chamber so as to inflate the glove, placing a hand in the inflated glove, and applying positive pressure to the cuff portion of the glove to release the glove from the opening of the vacuum chamber.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application claims priority to U.S. Provisional Patent Application No. 60/244,026, filed Oct. 27, 2000, the contents of which are herein incorporated by reference. 
    
    
     FIELD OF THE INVENTION 
     This invention relates in general to the field of vacuum technology and in particular to devices and methods that use vacuum principles to ensure the sterility of surgical gloves. 
     BACKGROUND OF THE INVENTION 
     Surgical gloves are worn in a variety of environments that demand a very high degree of sterility, for example, the medical, food-preparation and manufacturing “clean room” environments. In the medical environment, surgical gloves are worn to prevent the hands of a doctor or a surgeon from contacting a patient&#39;s body during a physical examination or a surgical operation. Wearing non-sterile surgical gloves in such an environment can lead to infection of the patient. In the “clean room” environment, surgical gloves are worn to prevent the hands of a technician from contacting wafers and other devices supporting highly sensitive electronic circuits. Wearing non-sterile gloves in such an environment can lead to contamination of the wafers and other devices, making them unsuitable for fabrication. 
     Typically, surgical gloves are manufactured to be sterile. This sterility can be adversely affected, however, by manufacturing defects, such as rips, tears, and holes in the glove fabric. Such manufacturing defects are not always visible to the naked eye. This sterility can also be adversely affected during the process in which the wearer puts on the surgical gloves. During this process, oils and other fluids on the hands can contact and contaminate the exterior surface of the gloves. Ordinarily, the risk of undesirable contamination in this process is reduced by having an assistant fit the surgical gloves over the hands of the wearer. 
     Conventional devices for determining whether manufacturing defects exist in a surgical glove are inaccurate and difficult to use. Moreover, conventional devices do not circumvent the need for an assistant to reduce the risk of contamination during the process in which the gloves are fitted to the hands of the wearer. 
     SUMMARY OF THE INVENTION 
     The present invention is directed to glove inflation apparatuses that can utilize both a vacuum source and a compressed gas source to accurately determine whether manufacturing defects exist in a pair of surgical gloves and to fit a surgical glove onto a hand in a manner ensuring a high degree of sterility without the need for outside assistance. 
     In accordance with one aspect of the present invention, a glove inflation apparatus includes at least one vacuum chamber that has an opening sized and shaped for receiving a glove and for establishing a fluid-tight seal between the glove and the vacuum chamber. The apparatus further includes a vacuum source which is connected to the chamber and a source of compressed gas which is in fluid communication with the glove. The apparatus further includes a switch that is connected to the vacuum source and the source of compressed gas. The switch has two states. In the first state, the switch permits the pump to evacuate the chamber. In the second state, the switch permits the source of compressed gas to expel the glove from the opening of the chamber. 
     In accordance with another aspect of the invention, the glove inflation apparatus can have both a first vacuum chamber and a second vacuum chamber. The first vacuum chamber can have an opening sized and shaped for receiving a first glove, and the second vacuum chamber can have an opening sized and shaped for receiving a second glove. 
     In accordance with a further aspect of the present invention, the glove inflation apparatus can include a controller connected to the switch. The controller can be a foot pedal or any other electrical or mechanical device which is suitable for controlling the switch. 
     In accordance with another aspect of the present invention, the vacuum chamber of the glove inflation apparatus can include a transparent portion to facilitate viewing of the glove while the glove is secured onto the opening of the vacuum chamber. 
     In accordance with another aspect of the present invention, the glove inflation apparatus can include a nozzle and a support ring sized and shaped to engage the opening of the vacuum chamber. The nozzle preferably directs the delivery of the compressed gas to the glove. 
     In accordance with a further aspect of the present invention, the glove inflation apparatus can include a glove assembly for supporting a cuff portion of a glove, a vacuum chamber that has an opening for receiving the glove assembly, a vacuum pump connected to the vacuum chamber, and a source of compressed gas connected to the glove assembly. 
     In accordance with another aspect of the present invention, the glove assembly of the glove inflation apparatus can include a glove, a support ring having an interior surface and an exterior surface, a nozzle, adjacent to the exterior surface of the support ring, wherein a first portion of the nozzle connects to the source of compressed gas, and wherein a second portion of the nozzle retains the glove. 
     In accordance with yet a further aspect of the present invention, the present invention is directed to a method for donning a sterile glove. The method comprises securing a cuff portion of a glove onto an opening of a vacuum chamber, generating a vacuum in the vacuum chamber to inflate the glove, placing a hand in the inflated glove and applying positive pressure to the cuff portion of the glove to release the glove from the opening of the vacuum chamber. 
     Further features and advantages of the present invention will become apparent from the following description of the preferred embodiment and from the claims. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS 
     FIG. 1 is a schematic view of a glove inflation apparatus constructed according to the present invention; 
     FIG. 2 is a flow-chart diagram illustrating a method for donning a glove according to the present invention; 
     FIG. 3 a  is a schematic view of a glove inflation apparatus constructed according to the present invention; 
     FIG. 3 b  is a more detailed illustration of the vacuum chambers for use in the apparatus shown in FIG. 3 a;    
     FIG. 4 a  is a schematic view in exploded cross-section of the apparatus shown in FIG. 3 a;    
     FIG. 4 b  is an assembled view of the apparatus shown in FIG. 4 a;    
     FIG. 5 is a schematic view of the apparatus shown in FIG. 3 a  illustrating the insertion of a glove assembly into the apparatus; 
     FIG. 6 is a side view of a support ring, nozzle and a vacuum chamber; and 
     FIGS. 7 a  and  7   b  are schematic views of the adjustable supports of the apparatus shown in FIG. 3 a.   
    
    
     DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS 
     An exemplary embodiment of a glove inflation apparatus  1  constructed according to the present disclosure is shown in FIG.  1 . The glove inflation apparatus  1  can be used to accurately determine whether a surgical glove contains any defects. The apparatus  1  can also be used to fit a surgical glove onto the hand of a wearer in a manner ensuring a high degree of sterility without the need for outside assistance. The apparatus  1  includes a vacuum chamber  12 , a vacuum source  4 , a positive pressure source  6 , a switch  7  and a controller  8 . As shown in FIG. 1, the vacuum source  4  is connected to (i.e., in fluid communication with) the vacuum chamber  12  via tubes  5  and  9  and the switch  7 . The vacuum source  4  can be a vacuum pump or a remotely-located vacuum reservoir. The source of compressed gas  6  is connected to the vacuum chamber  12  via tubes  3  and  5  and the switch  7 . The pressure within the vacuum chamber  12  is regulated by the switch  7  which is controlled, e.g., electrically or mechanically, by the controller  8 . The switch  7  of FIG. 1 can be an automatic or manually-controlled three-way control valve. 
     As shown in FIG. 1, vacuum chamber  12  has an opening  20  defined by a protruding collar  18  for receiving a glove assembly (described below). The opening  20  is sized and shaped for receiving a glove, and more specifically, the cuff portion of a glove. When the apparatus  1  is used to fit a surgical glove onto the hand of a wearer, the opening  20  must be sized and shaped to also allow the wearer&#39;s hand to fit through the opening  20 . Collar  18  is surrounded by a gasket  22 . The gasket  22 , which may be an O-ring, a flat gasket, a tapered gasket or any other suitable type of gasket device, may be seated within a channel, i.e., a groove (not shown) manufactured into the collar  18 . 
     Operation of the glove inflation apparatus  1  will be described in connection with FIG. 2 which illustrates an exemplary method for donning a sterile glove in accordance with the present disclosure. The cuff portion of a glove  100  (see FIG. 5) is secured onto the opening  20  of a vacuum chamber  12  to establish a fluid-tight seal between the glove  100  and the vacuum chamber  12 , step  102 . A vacuum is then generated in the vacuum chamber  12  by operation of the vacuum source  4 , switch  7  and controller  8 , step  104 . The vacuum generated in the vacuum chamber  12  needs to be controlled, i.e., set at an appropriate level, such that the fluid-tight seal established between the glove  100  and the vacuum chamber  12  does not get compromised, and such that the glove  100  does not get over inflated. Over inflation of the glove  100  may detrimentally affect the integrity of the glove  100 &#39;s material. 
     If the glove  100  is free of defects, i.e., there are no holes or tears in the glove, and a fluid-tight seal between the glove  100  and the vacuum chamber  12  has been established, the negative pressure in the vacuum chamber  12  will cause the secured glove  100  to inflate. Once a vacuum has been established, the operator (who may or may not be the same person who shall ultimately wear the glove) then verifies the integrity of glove  100  by observing whether the glove  100  has fully inflated or not, step  106 . If there are perforations, tears or holes in the glove  100 , the glove  100  will not inflate, or will only partially inflate. If the glove  100  fails to fully inflate, the glove  100  is removed from the opening  20  of the vacuum chamber  12  and discarded, step  114 . If the glove  100  fully inflates, the hand (to be gloved) is placed within the inflated glove  100 , step  108 . Positive pressure is then applied to the cuff portion of the glove  100  to release the glove  100  from the opening  20  of the vacuum chamber  12 , step  110 . The amount of positive pressure necessary to cause the glove  100  to be released from the opening  20  will depend upon the type of glove used and the manner in which the glove  100  is secured onto the opening  20  of the vacuum chamber  12 . For most types of readily-available surgical gloves, a positive pressure of at least eight (8) p.s.i. can be sufficient to release the glove  100  from the opening  20 . Finally, the gloved hand is removed from the opening  20  of the vacuum chamber  12 , step  112 . 
     An alternate embodiment of a glove inflation apparatus  2  constructed according to the present disclosure is shown in FIG. 3 a.  The glove inflation apparatus  2  can be used to accurately determine whether a pair of surgical gloves contains any defects. The apparatus  2  can also be used to fit a pair of surgical gloves onto the hands of a wearer in a manner ensuring a high degree of sterility without the need for outside assistance. The apparatus  2  includes two vacuum chambers  12 . Each vacuum chamber  12  has a cutout  14  in its top surface. As shown in FIGS. 3 b  and  4   a,  each cutout  14  is suitably sized and shaped to receive a transparent cover  24  surrounded by a gasket  30 . The cover  24  and the gasket  30  are assembled to the vacuum chamber  12  so as to create a fluid-tight seal. Stud screws  34 , keepers  26 , and lugs  32  are used to secure the cover  24  and the gasket  30  to the vacuum chambers  12 . 
     As also shown in FIG. 3 a,  the apparatus  2  includes a pump chamber  10 . Located within the pump chamber  10  is a vacuum pump  66  having an outlet port  70 . Like the vacuum chambers  12 , the pump chamber also has a cutout  14  in its top surface for receiving a transparent cover  24  surrounded by a gasket  30 . Assembly of the cover  24  to the pump chamber  10  follows the technique described above for assembling the cover  24  to the vacuum chamber  12 . 
     As shown in FIGS. 3 b,    4   a,  and  4   b,  the vacuum chambers  12  and the pump chamber  10  are physically connected to each other. This connection is accomplished by first inserting bolts  82  through upper stiles  42  and lower stiles  44  having receiving bores  28  and later securing the bolts  82  with nuts  46 . Clevises  16  are also used to physically connect the chambers in the manner indicated in FIGS. 4 a  and  4   b.    
     As shown in FIGS. 3 a,    3   b,  and  4   a,  each vacuum chamber  12  has an opening  20  defined by a protruding collar  18 . Each collar  18  is surrounded by a gasket  22 . The gasket  22 , while shown to be a tapered gasket, can be an O-ring, a flat gasket, a tapered gasket or any other suitable type of gasket device. Also, gasket  22  can be seated within a channel (not shown) manufactured into the collar  18 . 
     As further shown in FIG. 3 a,  the vacuum pump  66  and the pump chamber  10  are connected to the vacuum chambers  12  via tubes  84  which pass through bulkhead fittings  78 . The vacuum pump  66  and the pump chamber  10  are also connected via a tube  84  to a switch  72  having a control valve  74 . The vacuum chambers  12  are connected to each other via tubes  84  which pass through the control valve  74  and enter grommets  88 . A source of compressed gas (not shown) is connected to the switch  72  via a tube  84  that enters through an inlet port  68 . The switch  72  is electrically connected to a junction box  86 , and the junction box  86  is electrically connected to a power supply  76  and a foot pedal  80  having two chambers. 
     As shown in FIGS. 4 a,    4   b,    5 ,  7   a,  and  7   b,  the apparatus  2  rests upon a pair of adjustable supports  90  located underneath the vacuum chambers  12 . The supports  90  comprise legs  38 , pivoting feet  40 , leg passages  36 , and locking nuts  50 . Alternatively, in other embodiments constructed in accordance with the present invention, additional adjustable supports can be used. 
     As illustrated in FIGS. 5 and 6, the support ring  60  and nozzle  62  are sized and shaped to engage the opening  20  of the chamber  12 . The support ring  60  has an interior surface and an exterior surface. The nozzle  62 , which is coupled to the exterior surface of the support ring  60 , has a first portion  62   a  which connects to the source of compressed gas, e.g., via grommet  88 , and a second portion  62   b  for retaining the glove  100 . The nozzle  62  can be bonded to the support ring  60  via traditional bonding, welding, and/or brazing techniques or any other suitable techniques which are well known to those skilled in the art. Alternatively, the nozzle  62  and the support ring  60  can be of an unitary construction. In other words, nozzle  62  and support ring  60  can be manufactured as a single component. The nozzle  62  and the support ring  60  can be made of plastic, metal or any other suitable material. 
     The glove  100  (not shown in FIG. 6 for sake of clarity) is placed within the interior surface of the support ring  60  and the opening of the glove  100  (i.e., the cuff portion of the glove) can be stretched over the retaining portion  62   b  of the nozzle  62  to secure the glove  100  to the nozzle  62 . The resiliency of the material used in the glove  100 , when stretched over the retaining portion  62   b  of the nozzle  62 , can aid in securing the glove  100  to the opening  20  of the vacuum chamber  12 . Also, surgical gloves often have a bead (or lip) of material along the opening of the glove  100 . The glove  100 &#39;s bead, when pulled over the retaining portion  62   b  of the nozzle  62 , can further aid in securing the glove  100  to the opening  20  of the vacuum chamber  12 . Nozzle  62  has a series of small holes  62   c,  i.e. orifices, located along the retaining portion  62   b  of the nozzle  62  which can direct the delivery of the compressed gas to the glove  100  once the first portion  62   a  of the nozzle  62  has been connected to the source of compressed gas. 
     Once the glove  100  is installed onto the support ring  60 -nozzle  62  assembly, the glove assembly  200 —consisting of the glove  100 , support ring  60  and the nozzle  62 —is then placed onto the collar  18  of the vacuum chamber  12  with the first portion  62   a  of the nozzle  62  connected to the source of compressed gas. For ease of operation, the glove assembly  200  can be manufactured as a pre-assembled package that is to be used with the glove inflation apparatuses disclosed herein. Alternatively, the support ring  60 -nozzle  62  assembly can be mated with the opening  20  of the vacuum chamber  12  prior to installing the glove  100  onto the support ring  60 -nozzle  62  assembly. 
     The frictional forces present between the collar  18 , gasket  22  and the support ring  60  can be sufficient to hold the support ring  60 -nozzle  62  assembly to the collar  18  when the glove inflation apparatus of the present disclosure is in use. Alternatively, however, mechanical locking devices or fasteners such as spring loaded bearing mechanisms or mechanical latches can utilized to secure the support ring  60 -nozzle  62  assembly to the collar  18 . Gasket  22 , located between the collar  18  and the interior surface of the support ring  60 , ensures that a fluid-tight seal is exists between the support ring  60  and the collar  18 . At this point, the vacuum chamber  12  is a fluid-tight compartment, provided that the glove  100  is free from any defects (manufacturing or otherwise) such as rips, tears, or holes. 
     As discussed above, the apparatus  2  has two stages of operation—a vacuum pumping stage, and a positive pressure stage. The directions of fluid flow through the tubes  84  during these two stages of operation are indicated by arrows in FIG. 3 a.    
     Referring to FIG. 3 a  again, once a pair of gloves  100  has been placed into the vacuum chambers  12 , the operator depresses the first chamber, i.e., the first button, of the foot pedal  80  to commence the vacuum pumping stage. In response, the foot pedal  80  directs the junction box  86  to send a signal to the switch  72  to close the control valve  74 . High-pressure gas then flows from the source of compressed gas (not shown) via tubes  84  through the switch  72  and into the vacuum pump  66 . Subsequently, the vacuum pump  66  begins to evacuate both of the vacuum chambers  12  simultaneously, discharging gas through the outlet port  70 . Provided that the gloves  100  do not have any manufacturing defects, evacuation of the vacuum chambers  12  will be accompanied by inflation of the gloves  100 . This inflation can be observed through the transparent covers  24  on top of the vacuum chambers  12 . If the gloves  100  do have manufacturing defects, however, the vacuum chambers  12  will not be fluid-tight. As a consequence, the vacuum pump  66  will not be able to evacuate the vacuum chambers  12 , and the gloves  100  will not inflate. Observation of the inflation of the gloves  100 , therefore, assures the operator that the gloves  100  are free of manufacturing defects that adversely affect sterility. 
     After observing the inflation of the gloves  100 , the operator places his hands into the gloves  100  and waits until the fit of the gloves  100  feels comfortable. At that time, the operator depresses the second chamber of the foot pedal  80  to commence the positive pressure stage. In response, the foot pedal  80  directs the junction box  86  to send a signal to the switch  72  to open the control valve  74 . High-pressure gas, preferably a sterile and clean high-pressure gas, then flows from the source of compressed gas (not shown) via tubes  84  through the control valve  74  into the grommets  88  and the nozzles  62  surrounding the support rings  60  of the gloves  100 . As the high-pressure gas circulates through the support rings  60 , it escapes through the small holes  62   c  in the nozzles  62 . This burst of positive pressure blows the gloves  100  off of the support rings  60  and onto the operator&#39;s hands. The apparatus  2  thus facilitates a fitting of surgical gloves that ensures a high degree of sterility without the need for outside assistance. 
     The glove inflation apparatus  2  thus achieves the objects of the present invention. The apparatus  2  can be used to inflate gloves of all sizes and of both latex and non-latex composition. 
     The present invention has been disclosed in connection with the glove inflation apparatuses  1  and  2  shown and described in detail. Various modifications and improvements thereon will, however, become readily apparent to those skilled in the art. For example, many variations are possible on the construction of the pump chamber  10  and the vacuum chambers  12 . Alternative embodiments of the present invention may be constructed without a pump chamber  10  or with a single vacuum chamber  12 . The vacuum chamber  12  preferably is constructed with an observation window by which to observe the inflation of the glove  100 . Many variations are also possible for the assembly of the glove  100  onto the opening  20  of the vacuum chamber  12  in a manner to create a fluid-tight seal between the glove  100  and the vacuum chamber  12 . Further, many variations are possible for the mechanism by which the glove  100  is fit onto the operator&#39;s hand. The description of the glove inflation apparatuses  1  and  2  should therefore be considered only as illustrative, and not as limiting, of the present invention. The spirit and scope of the present invention is to be limited only by the following claims.