Abstract:
A device for automatically dispensing lubricating gel for medical procedures that reduces the chance of cross-contamination between patients by use of a shape that prevent accidental contact with the dispenser, anti-microbial materials, and a dispensing valve protection device.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    The present application claims the priority of U.S. provisional patent application Ser. No. 61/353,301 filed on Jun. 10, 2010, which is incorporated herein be reference. 
     
    
     FIELD OF THE INVENTION 
       [0002]    The invention relates generally to the fields of fluid handling and medicine. More particularly, the invention relates to methods and devices for dispensing lubricating gel in a clinical setting. 
       BACKGROUND 
       [0003]    Lubricating jellies and other lubricants are used in a large variety of medical procedures such as ultrasound imaging and examination of orifices. In pelvic and rectal exams, lubricants increase patient comfort by reducing friction that can irritate delicate tissues. Lubricating jelly is typically supplied in large squeeze tubes or bottles, or in single-use packets. For the former, a health care provider will squeeze a suitable amount of the lubricant onto gloved fingers and then apply the lubricant to the patient. In cases where a health care provider performs multiple examinations in a day (e.g., an obstetrician/gynecologist), use of squeeze tubes or bottles can create a significant risk of cross-contamination—i.e., bodily fluids or tissues from one patient are inadvertently transferred to another patient. Although the health care provider will change gloves between each patient, if the provider handles the tube or bottle with gloves used to examine a patient, there is a good chance that the tube or bottle will become contaminated with that patient&#39;s bodily fluids or tissue. Because few health care providers clean the lubricant tube or bottle between patients, the next use of the tube or bottle can transfer a previous patient&#39;s bodily fluids or tissue first onto the gloves of the health care provider and then onto the next patient. 
         [0004]    Many practitioners are concerned about this issue and try to avoid contamination by using only one hand to contact the patient and the other hand to obtain lubricant from the squeeze tube or bottle. This of course can be quite awkward or even impossible to perform—especially in the case where two hands are required for the patient examination. As a result, lubricant containers are often contaminated—sometimes visibly so. 
         [0005]    To overcome this problem, medical lubricants are also sold in single-use foil packets that are torn open for each use. Unfortunately, opening an individual packet of gel can be a messy and cumbersome process. And occasionally, a packet will cut the health care provider&#39;s protective glove—a dangerous and unsanitary situation for both the practitioner and the patient. 
       SUMMARY 
       [0006]    The invention is based on the development of a device for dispensing of lubricating jelly that is specifically designed to reduce the potential of patient to patient cross contamination and to be easy to use by a health care provider. The device dispenses a predetermined volume of lubricant automatically when a health care provider&#39;s hand is placed near a sensor on the device, and importantly is shaped and sized to prevent a user&#39;s hand or glove from accidentally touching any component of the dispensing device. The device can be coated with suitable anti-microbial agents—particularly at those areas likely to be accidently touched by a user. A removable and cleanable guard can also be used to prevent accidental touching of the dispensing valve. 
         [0007]    Accordingly, the invention features an automatic lubricant dispenser that includes a top component having at its front end a dispensing component, the dispensing component including a dispensing valve for dispensing the lubricant, a base for supporting the dispenser on a flat surface, and a middle component connecting the top component to the base, wherein the front portion the top component extends away from the middle of the front portion of the middle component at least 5 cm (e.g., at least 10 or 15 cm). The dispenser might also include a sensor for detecting the proximity of a user&#39;s hand to the dispensing valve and thereby activating a signal which causes the dispenser to deliver lubricant through the dispensing valve. The dispenser might also feature a contamination guard located in the front portion of the top component partially surrounding the dispensing valve. The contamination guard can be removable from the dispenser and/or be composed of (e.g., be made of, be coated with, or be impregnated with) an anti-microbial material. In one variation, the front portion of the middle component can include an anti-microbial material. 
         [0008]    Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention, suitable methods and materials are described below. All publications mentioned herein are incorporated by reference in their entirety. In the case of conflict, the present specification, including definitions will control. In addition, the particular embodiments discussed below are illustrative only and not intended to be limiting. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0009]      FIG. 1  is a schematic illustration of a lubricant dispensing device of the invention shown with a lubricating gel cartridge installed. 
           [0010]      FIG. 2  is a schematic illustration of the lubricating gel cartridge and the lubricant dispensing device of  FIG. 1  shown with the lubricating gel cartridge removed. 
       
    
    
     DETAILED DESCRIPTION 
       [0011]    The invention encompasses methods, devices, and kits for hygienically dispensing lubricants in a clinical setting. The below described preferred embodiments illustrate adaptation of these methods, devices, and kits. Nonetheless, from the description of these embodiments, other aspects of the invention can be made and/or practiced based on the description provided below. 
       Dispensing Devices 
       [0012]    Referring now to  FIG. 1 , in an exemplary embodiment of the invention, an automatic lubricating gel dispenser  5  includes a base  10 , a top component  20 , and a middle component  30  connecting the base  10  to the top component  20 . The front portion of the top component  20  (and optionally of the base  10  as shown in  FIG. 1 ) extends away from the middle of the front portion  31  of the middle component  30  at least about 5 cm (e.g., at least 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19 or 20 cm) to reduce the chance that a user&#39;s hand or glove will accidentally touch and possibly contaminate the middle component  30 . The front portion of the middle component  30  is shown in  FIG. 1  as arcuate, although other arrangements are possible, e.g., straight. 
         [0013]    The height of the dispenser  5  should be sufficient so that a user can comfortably place his hand under the front portion  21  of the top component  20 , e.g., at least 10 cm, but preferably at least 15 or 20 cm. The height of the middle component  30  should also be sufficient for a user to comfortably place his hand under the front portion  21  of the top component  20  without contacting any part of the dispenser  5 , e.g., at least 8 cm, but preferably at least 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 or more cm. 
         [0014]    In the embodiment shown in  FIG. 1 , although other configurations are possible, the base  10  is shaped and sized to securely sit on a flat surface such as a table top. For example, the bottom of base  10  can be substantially planar and made of a high friction material such as synthetic rubber. The base  10  is preferably sufficiently dimensioned to prevent tipping of the dispenser  5 , e.g., at least 8, 9, 10, 11, 12, 13, or 14 cm wide by at least 8, 9, 10, 11, 12, 13, or 14 cm long. Optionally, the base  10  can include a device for fastening the dispenser  5  to a flat surface, e.g., a suction cup  14 , an adhesive film, a magnet, or a hook and loop type fastener. A drip pan  12  can be included in the front portion of the base  10  to catch any excess lubricant that might drip after being dispensed. Preferably, the drip pan  12  is removable from the base  10  for easy cleaning. 
         [0015]    The dispenser  5  can be powered by any suitable means. Generally, the dispenser will be powered by electricity from batteries and/or an external current source. In the latter case, the dispenser  5  would include an electrical power cord  16  which could be located on the base  10  as shown in  FIG. 1 , or less preferably on the top component  20  or the middle component  30 . 
         [0016]    The top component  20  can have a spout-like shape and a length of at least 10 cm, but preferably at least 15 or 20 cm so that a user can place his or her hand under the middle component  20  with little chance of accidently contacting the front portion of the middle component  20 . The top component  20  can include a dispensing component  22  on the bottom side of its front end as shown in  FIG. 1 . The dispensing component  22  includes a dispensing valve  23  from which lubricant is dispensed, and optionally, a contamination guard  24  which partially surrounds the dispensing valve  23  (without blocking the delivery of lubricant) and protects it from being accidentally touched and contaminated by a user. The guard preferably extends downward farther (e.g., at least 0.3, 0.5, 0.75, 1, 1.5., or 2 cm) than the outlet on valve  23  to protect the outlet from accidentally being touched by a user. The contamination guard  24  is preferably removable from the dispenser  5  for easy cleaning. It can be made of any suitable material such as a plastic or metal, and can also be composed of an anti-microbial material (e.g., such as silver, an anti-microbial polymer, or an anti-microbial nanocomposite material). In an alternative configuration, rather than using a guard  24  to protect the valve  23 , the valve can be recessed (e.g., at least 0.3, 0.5, 0.75, 1, 1.5., or 2 cm) in an opening or bore on the underside of the front portion  21  of the top component  20 . In this arrangement, the portions of the top component  20  near the opening or bore could be composed of an anti-microbial material. 
         [0017]    To detect the hand of a user and thereby cause the dispenser  5  to dispense lubricant, the dispenser can include a sensor  25  such as an infrared sensor which detects the proximity of the users hand and responds by sending signals to other components (e.g., an electrical pump, conduits, and valves interposed between the lubricant storage component and the valve  23 ) of the dispenser  5  which cause the lubricant to be dispensed through the valve  23 . The sensor  25  can be located on the top component  20  as shown in  FIG. 1 , but might also be located on the middle component  30  or the base  10 . A number of suitable sensors, pumps, and other components of this system are well known in the art. 
         [0018]    A refill warning device  26  such as a light or sound generator can also be included on the dispenser  5  to signal to a user that lubricant needs to be added. The dispenser  5  can also include a lubricant volume controller  28  which controls how much lubricant is dispensed per activation. This controller might be a rheostat or could be a switch with set volume levels (e.g., levels 1, 2, and 3). The amount of lubricant dispensed per activation could be between 2-10 ml (e.g., 2, 3, 4, 5, 6, 7, 8, 9, or 10 ml +/−10%). 
         [0019]    The middle component  30  can include a reservoir into which lubricant is poured and stored, or preferably as shown in  FIGS. 1 and 2 , an acceptor  32  for a pre-filled lubricant cartridge  34 . The acceptor  32  can be specifically designed to securely hold the cartridge  34  and align it with tubes that communicate with the valve  23  and other components such as a pump. The acceptor  32  might also be designed to puncture a sealing mechanism of the cartridge  34  so that lubricant would only be allowed to flow out of the cartridge  34  once the sealing mechanism was punctured. In the embodiment shown in  FIG. 1 , a window  36  for showing the level of lubricant runs vertically through the outer wall of the cartridge  34 . The middle component  30 , and particularly the front portion of this component  30 , can include an anti-microbial material (see above) that could help kill any viruses and/or bacteria that might accidentally get on this component. 
         [0020]    For patient comfort, the dispenser  5  might also include a heating unit  38  (shown on the bottom portion of the middle component  30  in the embodiment shown in  FIG. 1 ) for warming the lubricant. The heating unit  38  could be an electrical heating unit that can warm the lubricant to greater than 30° C. (e.g., 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40 or more ° C.). 
         [0021]    As mentioned above, the outer surface of various parts of the dispenser  5  that are most likely to be accidentally contacted by a user&#39;s hand can include an anti-microbial material. In addition to this, the surface of the components making up the dispenser can be composed of materials that are resistant to being degraded by commonly used medical disinfectants such as alcohol. These materials might include metals (e.g., stainless steel, copper, and silver) or solvent-resistant plastics. 
         [0022]    In operation, a health care provider preparing to apply lubricant to a patient would place a gloved hand under the dispensing component  22  without touching any part of the dispenser. The sensor  25  would detect the gloved hand and send a signal to a pump or like device that would signal the dispenser  5  to move lubricant from the cartridge  34  out through the valve  23 . Because the dispenser  5  is never touched by the health care provider, he or she can obtain lubricant without contaminating the dispenser  5  even with a glove that might have a patient&#39;s bodily fluid or tissues on it. The elongation of top component  20  greatly reduces the chance that a health care provider will accidently touch the dispenser  5 , and the contamination guard  24  prevents a user from accidently touching the dispensing valve  23 . 
       Other Embodiments 
       [0023]    It is to be understood that while the invention has been described in conjunction with the detailed description thereof, the foregoing description is intended to illustrate and not limit the scope of the invention, which is defined by the scope of the appended claims. For example, the dispenser might be configured for wall mounting by having a means for securing the dispenser to a wall. Other aspects, advantages, and modifications are within the scope of the following claims.