Patent Publication Number: US-2022211993-A1

Title: Medical disinfectant caps

Description:
DESCRIPTION OF RELATED ART 
     The disclosed technology relates generally to medical devices, and more particularly, some embodiments relate to systems and methods for such devices. 
     SUMMARY 
     In general, one aspect disclosed features a cap for disinfecting a medical device, the cap comprising: a cylindrical receiving portion having an opening configured to receive a medical device, the cylindrical receiving portion comprising internal threads configured to mate with external threads of the medical device; disinfectant disposed within the cylindrical receiving portion; a cylindrical stem disposed longitudinally within the cylindrical receiving portion; and an annular sponge disposed about the cylindrical stem and contacting the disinfectant. 
     Embodiments of the cap may include one or more of the following features. In some embodiments, the annular sponge is made of polyurethane. In some embodiments, the annular sponge is approximately ¼ inch thick. Some embodiments comprise one or more longitudinal grooves formed in the cylindrical stem. Some embodiments comprise a removable seal configured to retain the disinfectant within the cylindrical receiving portion. In some embodiments, the medical device comprises one of: a female luer lock; or a needleless valve. 
     In general, one aspect disclosed features a cap for disinfecting a medical device, the cap comprising: a cylindrical receiving portion having an opening configured to receive a medical device; a cylindrical stem disposed longitudinally within the cylindrical receiving portion; and disinfectant disposed within the cylindrical receiving portion. 
     Embodiments of the cap may include one or more of the following features. In some embodiments, the cylindrical receiving portion comprises: internal threads configured to mate with external threads of the medical device. Some embodiments comprise an annular sponge disposed about the cylindrical stem and contacting the disinfectant. In some embodiments, the annular sponge is made of polyurethane. In some embodiments, the annular sponge is approximately ¼ inch thick. Some embodiments comprise one or more longitudinal grooves formed in the cylindrical stem. Some embodiments comprise a removable seal configured to retain the disinfectant within the cylindrical receiving portion. In some embodiments, the disinfectant is 70/30 isopropyl alcohol. In some embodiments, the medical device comprises one of: a female luer lock; or a needleless valve. 
     In general, one aspect disclosed features a method of disinfecting a medical device, the method comprising: providing a medical device; providing a cap, the cap comprising: a cylindrical receiving portion having an opening configured to receive a medical device, a cylindrical stem disposed longitudinally within the cylindrical receiving portion, and disinfectant disposed within the cylindrical receiving portion; and inserting the medical device into the cylindrical receiving portion of the cap such that the disinfectant contacts the medical device. Embodiments of the method may include one or more of the following features. In some embodiments, the cylindrical receiving portion comprises internal threads configured to mate with external threads of the medical device, the method further comprising: turning the cap with respect to the medical device such that the internal threads of the cap engage external threads of the medical device. In some embodiments, the cap comprises an annular sponge disposed about the cylindrical stem and contacting the disinfectant, the method further comprising: turning the cap with respect to the medical device such that the internal threads of the cap engage external threads of the medical device and the annular sponge is compressed to release the disinfectant. Some embodiments comprise removing the medical device from the cylindrical receiving portion of the cap; and allowing the disinfectant to dissipate from the medical device. In some embodiments, the medical device comprises one of: a female luer lock; or a needleless valve. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The present disclosure, in accordance with one or more various embodiments, is described in detail with reference to the following figures. The figures are provided for purposes of illustration only and merely depict typical or example embodiments. 
         FIG. 1  is an illustration of a medical disinfectant cap according to some embodiments of the disclosed technology. 
         FIG. 2  is an illustration of an annular sponge according to some embodiments of the disclosed technology. 
         FIG. 3  is an illustration of medical disinfecting cap having a grooved stem according to some embodiments of the disclosed technology. 
         FIG. 4  illustrates a removable seal according to some embodiments of the disclosed technology. 
         FIG. 5  illustrates a sealed cap according to some embodiments of the disclosed technology. 
         FIG. 6  illustrates a medical disinfectant cap and a 3-way stopcock having a female luer lock prior to connecting the cap to the stopcock. 
         FIG. 7  illustrates the medical disinfectant cap as connected to the 3 way stopcock. 
         FIGS. 8-10  are cross-sections of the medical disinfectant cap and the female luer lock of  FIGS. 6 and 7 . 
       In  FIG. 8 , the cap and the female luer lock have been brought into contact, but their threads have not engaged. 
       In  FIG. 9 , the cap has been threaded partially onto the female luer lock, and the female luer lock has made contact with the sponge. 
       In  FIG. 10 , the cap has been threaded fully onto the female luer lock, which has compressed the sponge, thereby releasing disinfectant to bathe and disinfect the exterior surfaces of the female luer lock. 
         FIG. 11  illustrates a medical disinfectant cap and a 3-way stopcock having a needleless valve prior to connecting the cap to the stopcock. 
         FIG. 12  illustrates the medical disinfectant cap as connected to the 3 way stopcock  1104 . 
         FIGS. 13-15  are cross-sections of the medical disinfectant cap and the needleless valve of  FIGS. 11 and 12 . 
       In  FIG. 13 , the cap and the needleless valve have been brought into contact, but their threads have not engaged. 
       In  FIG. 14 , the cap has been threaded partially onto the needleless valve  1106 , and the needleless valve has made contact with the sponge  1302 . 
       In  FIG. 15 , the cap has been threaded fully onto the needleless valve, which has compressed the sponge, thereby releasing disinfectant to bathe and disinfect the exterior surfaces of the needleless valve, including the surface of the silicone insert of the needleless valve. 
         FIG. 16  is a flowchart illustrating a process for disinfecting a medical device according to some embodiments of the disclosed technologies. 
     
    
    
     The figures are not exhaustive and do not limit the present disclosure to the precise form disclosed. 
     DETAILED DESCRIPTION 
     It is often desirable to administer fluids to patients intravenously. Intravenous fluid delivery systems often include connectors that allows the patient to leave the fluid delivery system temporarily, for example when the patient would like to visit the bathroom. But while disconnected, the connectors are exposed to the environment, and may become contaminated. To reduce the risk of contamination, the connectors are usually disinfected before reconnection. For example, the connectors may be disinfected using a swab containing a disinfectant fluid. 
     Embodiments of the disclosed technology provide medical disinfectant caps for disinfecting medical devices, and methods for using the medical disinfectant caps to disinfect medical devices. The disclosed medical disinfectant caps may include internal threads for mating with the external threads of a medical device. The caps may include disinfectant. A medical device may be disinfected by simply threading the cap onto the medical device, thereby allowing the disinfectant to contact and disinfect the medical device. The disinfectant may be 70/30 isopropyl alcohol. In the disclosed embodiments, the kill levels achieved may match or exceed competition kill levels. 
     In some embodiments, the caps include a sponge soaked with the disinfectant. In these embodiments, threading the cap onto the medical devices compresses the sponge, thereby releasing the disinfectant to contact and disinfect the medical device. 
     The caps may include a cylindrical stem disposed longitudinally within the cap. The stem may be configured to prevent the disinfectant from entering an interior space of the medical device, while allowing the disinfectant to bathe exterior surfaces of the medical device. These embodiments are especially useful for disinfecting female luer locks, and similar medical devices. 
     In some embodiments having a stem, one or more longitudinal grooves may be formed in the stem to allow the disinfectant to flow past the stem. These embodiments are especially useful for disinfecting needleless valves, and similar medical devices. 
     In embodiments having a stem, the sponge soaked with disinfectant may be annular and disposed about the cylindrical stem. In some embodiments, the caps may be sealed with a removable seal to retain the disinfectant until use. 
       FIG. 1  is an illustration of a medical disinfectant cap  100  according to some embodiments of the disclosed technology. Referring to  FIG. 1 , the cap  100  may include a cylindrical receiving portion  102  having an opening  104  configured to receive a medical device. The cylindrical receiving portion  102  may include internal threads  106 . The internal threads  106  may be configured to mate with external threads of a medical device. 
     The cap  100  may include a cylindrical stem  108  disposed longitudinally within the cylindrical receiving portion  102 . The cylindrical stem  108  may prevent the disinfectant from entering the interior of a medical device such as a female luer lock. 
     In some embodiments, the cap  100  may include an annular sponge.  FIG. 2  is an illustration of an annular sponge  200  according to some embodiments of the disclosed technology. The annular sponge  200  may be made of polyurethane, or similar materials. In some embodiments, the annular sponge is approximately ¼ inch thick. The annular sponge  200  may be disposed about the cylindrical stem  108 , and may be soaked with disinfectant. 
     In some embodiments, the stem of the cap may include one or more longitudinal grooves.  FIG. 3  is an illustration of medical disinfecting cap  300  having a grooved stem according to some embodiments of the disclosed technology. Referring to  FIG. 3 , the cap  300  may include a cylindrical receiving portion  302  having an opening  304  configured to receive a medical device. The cylindrical receiving portion  302  may include internal threads  306 . The internal threads  306  may be configured to mate with external threads of a medical device. The cap  300  may include a cylindrical stem  308  disposed longitudinally within the cylindrical receiving portion  302 . The cap  300  may include an annular sponge such as the annular sponge  200  of  FIG. 2 . The annular sponge may be something disinfectant. The cap  300 , sponge, and disinfectant, may be sealed using a removable seal such as the removable seal  400  of  FIG. 4 . 
     The cylindrical stem  308  may include one or more longitudinal grooves  310 . The grooves  310  may allow the disinfectant to flow past the stem  308  to bathe an interior surface of a medical device such as a needless valve, and similar medical devices. 
     In some embodiments, the cap  100  may be sealed with a removable seal prior to use.  FIG. 4  illustrates a removable seal  400  according to some embodiments of the disclosed technology. Referring to  FIG. 4 , the removable seal  400  may include a cylindrical body portion  402  for sealing the opening  104  of the cap  100 , as well as a tab portion  404  that may be grasped to facilitate removal of the removable seal  400 . The removable seal  400  may be made of aluminum, or similar materials. 
       FIG. 5  illustrates a sealed cap according to some embodiments of the disclosed technology. Referring to  FIG. 5 , a cap  502  is sealed with a removable seal  504 . The cap  502  may be implemented as the cap  100  of  FIG. 1 , the cap  300  of  FIG. 3 , or other embodiments of the disclosed caps. The removable seal  504  may be implemented as the removable seal  400  of  FIG. 4 , or other embodiments of the disclosed removable seals. 
       FIG. 6  illustrates a medical disinfectant cap  602  and a 3-way stopcock  604  having a female luer lock  606  prior to connecting the cap  602  to the stopcock  604 . The cap  602  may be implemented for example as the cap  100  of  FIG. 1 . The stem of the cap  602  may have no grooves, and therefore when connected prevents the disinfectant in the cap  602  from entering the interior of the stopcock  604 .  FIG. 7  illustrates the medical disinfectant cap  602  as connected to the 3 way stopcock  604 . 
       FIGS. 8-10  are cross-sections of the medical disinfectant cap  602  and the female luer lock  606  of  FIGS. 6 and 7 . In each of  FIGS. 8-10 , an annular sponge  802  is disposed within the cap  602 . In  FIG. 8 , the cap  602  and the female luer lock  606  have been brought into contact, but their threads have not engaged. 
     In  FIG. 9 , the cap  602  has been threaded partially onto the female luer lock  606 , and the female luer lock  606  has made contact with the sponge  802 . 
     In  FIG. 10 , the cap  602  has been threaded fully onto the female luer lock  606 , which has compressed the sponge  802 , thereby releasing disinfectant to bathe and disinfect the exterior surfaces of the female luer lock  606 . 
       FIG. 11  illustrates a medical disinfectant cap  1102  and a 3-way stopcock  1104  having a needleless valve  1106  prior to connecting the cap  1102  to the stopcock  1104 . The cap  1102  may be implemented for example as the cap  300  of  FIG. 3 . The stem of the cap  1102  may have one or more longitudinal grooves that allow the disinfectant in the cap  1102  to pass the stem to contact the exterior surfaces of the needleless valve  1106 .  FIG. 12  illustrates the medical disinfectant cap  1102  as connected to the 3-way stopcock  1104 . 
       FIGS. 13-15  are cross-sections of the medical disinfectant cap  1102  and the needleless valve  1106  of  FIGS. 11 and 12 . In each of  FIGS. 13-15 , an annular sponge  1302  is disposed within the cap  1102 . In  FIG. 13 , the cap  1102  and the needleless valve  1106  have been brought into contact, but their threads have not engaged. 
     In  FIG. 14 , the cap  1102  has been threaded partially onto the needleless valve  1106 , and the needleless valve  1106  has made contact with the sponge  1302 . 
     In  FIG. 15 , the cap  1102  has been threaded fully onto the needleless valve  1106 , which has compressed the sponge  1302 , thereby releasing disinfectant to bathe and disinfect the exterior surfaces of the needleless valve  1106 , including the surface of the silicone insert  1304  of the needleless valve. 
       FIG. 16  is a flowchart illustrating a process  1600  for disinfecting a medical device according to some embodiments of the disclosed technologies. For example, the process  1600  may be employed to disinfect the female luer lock  606  of  FIG. 6  using the cap  100  of  FIG. 1 . As another example, the process  1600  may be employed to disinfect the needleless valve  1106  of  FIG. 11  using the cap  300  of  FIG. 3 . 
     The elements of the process  1600  are presented in one arrangement. However, it should be understood that one or more elements of the process may be performed in a different order, in parallel, omitted entirely, and the like. Furthermore, the process  1600  may include other elements in addition to those presented. 
     Referring to  FIG. 16 , the process  1600  may include providing a medical device, at  1602 . For example, the medical device may be a female luer lock, a needleless valve, or a similar medical device. 
     The process  1600  may include providing a medical disinfectant cap, the cap comprising a cylindrical receiving portion having an opening configured to receive a medical device, a cylindrical stem disposed longitudinally within the cylindrical receiving portion, and disinfectant disposed within the cylindrical receiving portion, at  1604 . 
     With continued reference to  FIG. 16 , the process  1600  may include inserting the medical device into the cylindrical receiving portion of the cap such that the disinfectant contacts the medical device, at  1606 . In some embodiments, the cylindrical receiving portion comprises internal threads configured to mate with external threads of the medical device. In these embodiments, inserting the medical device into the cylindrical receiving portion of the cap may include turning the cap with respect to the medical device such that the internal threads of the cap engage external threads of the medical device. In some of these embodiments, the cap includes an annular sponge disposed about the cylindrical stem and contacting the disinfectant. In such embodiments, the process may include turning the cap with respect to the medical device such that the internal threads of the cap engage external threads of the medical device and the annular sponge is compressed to release the disinfectant. 
     The process  1600  may include removing the medical device from the cylindrical receiving portion of the cap, at  1608 , and allowing the disinfectant to dissipate from the medical device, at  1610 . For example, the disinfectant may dissipate in approximately one minute. At this point, the medical device is disinfected, and may be connected to the IV system again. 
     As used herein, the term “or” may be construed in either an inclusive or exclusive sense. Moreover, the description of resources, operations, or structures in the singular shall not be read to exclude the plural. Conditional language, such as, among others, “can,” “could,” “might,” or “may,” unless specifically stated otherwise, or otherwise understood within the context as used, is generally intended to convey that certain embodiments include, while other embodiments do not include, certain features, elements and/or steps. 
     Terms and phrases used in this document, and variations thereof, unless otherwise expressly stated, should be construed as open ended as opposed to limiting. Adjectives such as “conventional,” “traditional,” “normal,” “standard,” “known,” and terms of similar meaning should not be construed as limiting the item described to a given time period or to an item available as of a given time, but instead should be read to encompass conventional, traditional, normal, or standard technologies that may be available or known now or at any time in the future. The presence of broadening words and phrases such as “one or more,” “at least,” “but not limited to” or other like phrases in some instances shall not be read to mean that the narrower case is intended or required in instances where such broadening phrases may be absent. 
     A person of ordinary skill in the art will recognize that they may make many changes to the details of the above-described memory device without departing from the underlying principles. Only the following claims, however, define the scope of the memory device.