Patent Publication Number: US-2021187265-A1

Title: Coupling device

Description:
CROSS-REFERENCE TO RELATED APPLICATION 
     This application claims the benefit of U.S. Provisional Patent Application No. 62/952,952, filed Dec. 23, 2019, which is incorporated by reference herein in its entirety. 
    
    
     FIELD 
     The present disclosure relates to coupling devices. More particularly, the present disclosure relates to coupling devices and related methods for coupling mixing jars to vaginal applicators, oral syringes, Luer-Lock syringes, and/or Slip-Tip syringes to facilitate compounding pharmacists and/or patients in the measurement and dosing of certain custom-mixed topical/vaginal creams, which treat a variety of needs such as hormone replacement for both men and women, vaginal dryness, vaginal yeast infections, and other indications. 
     BACKGROUND 
     The traditional role of compounding pharmacies is to make drugs prescribed by doctors for specific patients with needs that can&#39;t be met by commercially available drugs. Examples include the following: 1) a patient may need a small or highly accurate dose of a drug that is only available in one standard concentration or 2) a patient may be allergic to one of the ingredients in a commercial version of a drug which requires a custom compound to address the patient&#39;s needs. 
     Topical/vaginal creams are almost universally prepared by compounding pharmacists by using mixing equipment, Unguator EMP (Electronic Mortar &amp; Pestal), manufactured and sold by Gako International GmbH. This mixing equipment provides different size mixing jars (EMP Jars), which can be chosen by the pharmacist depending on the quantity of the compound desired. 
     Once the topical cream or vaginal cream is mixed, it must be provided to the patient(s) in such a way that it is easy to dose and administer and ideally requires the least amount of cost and time invested by the compounding pharmacist. A number of methods are currently used to accomplish this, none of which is entirely satisfactory. 
     Accordingly, a new method is needed that eliminates or greatly reduces the disadvantages created by the current methods. 
     SUMMARY 
     Disclosed herein are coupling devices and related methods for facilitating the delivery and dosing of certain compounded topical/vaginal creams for compounding pharmacists and/or their patient customers. As an example, a common application would be custom hormone replacement therapy regimes that are not available in commercial tablet form, where the patient may need a small, custom, liquid dose of a drug mixture, either topically applied to the skin or delivered via a vaginal applicator. 
     In some embodiments, the coupling device comprises: a female fitting adapted attach a mixing jar thereto; and a male fitting adapted to attach a vaginal applicator or an oral syringe thereto; or a male fitting adapted to attach a Luer-Lock syringe or a Slip-Tip syringe thereto. 
     In some embodiments, the method for coupling a mixing jar to a vaginal applicator or an oral syringe comprises: providing a coupling device comprising: a female fitting adapted to attach the mixing jar; and a male fitting adapted to attach the vaginal applicator or the oral syringe thereto; attaching the female fitting of the coupling device to the mixing jar; and attaching the male fitting of the coupling device to the vaginal applicator or the oral syringe. 
     In some embodiments, the method for coupling a mixing jar to a Luer-Lock syringe or a Slip-Tip syringe comprises: providing a coupling device comprising a female fitting adapted to attach the mixing jar; and a male fitting adapted to attach the Luer-Lock syringe or the Slip-Tip syringe thereto; attaching the female fitting of the coupling device to the mixing jar; and attaching the male fitting of the coupling device to the Luer-Lock syringe or the Slip-Tip syringe. 
     In some embodiments, the female fitting includes a top wall and a cylindrical wall depending from a peripheral edge of the top wall. 
     In some embodiments, the cylindrical wall includes an inner surface and a thread disposed on the inner surface. 
     In some embodiments, the male fitting includes a cylindrical member disposed on the top wall of the female fitting. 
     In some embodiments, the cylindrical member has an outer surface, an inner surface, a thread disposed on the outer surface and the inner surface defining a passageway. 
     In some embodiments, the thread is a screw-thread or a Luer-Lock thread. 
     In some embodiments, the thread is a screw-thread and the inner surface is tapered. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWING 
       The disclosure is best understood from the following detailed description when read in conjunction with the accompanying drawing. It is emphasized that, according to common practice, the various features of the drawing are not necessarily to scale. On the contrary, the dimensions of the various features may be arbitrarily expanded or reduced for clarity. Like numerals denote like features throughout the specification and the drawing. 
         FIG. 1A  is a perspective view of a first embodiment of a coupling device; 
         FIG. 1B  is a side view of the coupling device of  FIG. 1A ; 
         FIG. 1C  is a top view of the coupling device of  FIG. 1A ; 
         FIG. 1D  is a cross-sectional view of the coupling device of  FIG. 1A  through line  1 D- 1 D of  FIG. 1C ; 
         FIG. 2A  is a perspective view of a second embodiment of a coupling device; 
         FIG. 2B  is a side view of the coupling device of  FIG. 2A ; 
         FIG. 2C  is a top view of the coupling device of  FIG. 2A ; 
         FIG. 2D  is a cross-sectional view of the coupling device of  FIG. 2A  through line  2 D- 2 D of  FIG. 2C ; 
         FIG. 3  is perspective view of an embodiment of a mixing jar; 
         FIG. 4A  is a plan view that shows the coupling device of  FIGS. 1A-1D  coupling a vaginal applicator with the mixing jar of  FIG. 3 ; 
         FIG. 4B  is a plan view that shows the coupling device of  FIGS. 1A-1D  coupling an oral syringe with the mixing jar of  FIG. 3 ; 
         FIG. 5A  is a plan view that shows the coupling device of  FIGS. 2A-2D  coupling a Luer-Lock syringe with the mixing jar of  FIG. 3 ; and 
         FIG. 5B  is a plan view that shows the coupling device of  FIGS. 2A-2D  coupling a Slip-Tip syringe with the mixing jar of  FIG. 3 . 
     
    
    
     DETAILED DESCRIPTION 
     It should be understood that the phraseology and terminology used below for the purpose of description and should not be regarded as limiting. The use herein of the terms “comprising,” “including,” “having,” “containing,” and variations thereof are meant to encompass the structures and features recited thereafter and equivalents thereof as well as additional structures and features. Unless specified or limited otherwise, the terms “attached,” “mounted,” “affixed,” “connected,” “supported,” “coupled,” and variations thereof are used broadly and encompass both direct and indirect forms of the same. 
     Referring now to  FIGS. 1A-1D , there is shown a first embodiment of a coupling device  100  for coupling a mixing jar (e.g., an Electronic Mortar and Pestal (EMP) jar) to a vaginal applicator or an oral syringe. The coupling device  100  generally comprises a male fitting  110  and a female fitting  120 . 
     The female fitting  120  of the coupling device  100  comprises an upwardly tapered circular top wall  122  and a cylindrical side wall  124  depending from a rounded peripheral edge  126  of the top wall  124 . The cylindrical side wall  124  of the female fitting  120  has an outer surface  128  and an inner surface  130 . The outer surface  128  of the side wall  124  includes a plurality of longitudinal scallops or grooves  132 , which extend into the rounded peripheral edge  126  of the top wall  124  and aid in gripping the coupling device  100  when attaching a vaginal applicator or an oral syringe to the coupling device  100  and/or when connecting the coupling device  100  to a mixing jar  150 . A standard female or internal thread  134  is provided on the inner surface  130  of the cylindrical side wall  124 . 
     As shown  FIGS. 1D, 3, 4A and 4B , the female or internal thread  134  of the female fitting  120  is adapted to complement a male thread  158  provided on a male fitting  156  extending up from a top wall  154  of a lid  152  of the mixing jar  150 . The internally threaded female fitting  120  allows the coupling device  100  to be screw-threaded onto the lid  152  of the mixing jar  150 . An inner surface  136  of the top wall  122  of the female fitting  120  defines a shoulder  138  above the internal thread  134  which is operative as a stop to ensure exact screw-tightening height and to prevent overtightening of the female fitting  120  of the coupling device  100  to the male fitting  156  of the mixing jar lid  152 . More particularly, a free end  160  of the male fitting  156  of the mixing jar lid  152  will abut against the shoulder  138  of the top wall  122  of the female fitting  120  when the coupling device  100  is properly screw-tightened to the male fitting  156  of the mixing jar lid  152 . The stop  138  is also operative as a seal to prevent leakage during product transfer between the coupling device  100  and the mixing jar  150 . 
     Referring again to  FIGS. 1A-1D , the male fitting  110  of the coupling device  100  is formed by a cylindrical member  112  extending up from a central portion of the upwardly tapered top wall  122  of the female fitting  120 . A standard thread  116  is provided on an outer surface  114  of the cylindrical member  112 . 
       FIG. 4A  shows the coupling device  100  coupled with a vaginal applicator  170 . As shown, the thread  116  on the outer surface  114  of the male fitting  110  is adapted to threadedly engage a thread  176  provided on an inner surface  174  and at an outlet end  172  of a standard vaginal applicator  170 . The threads  116 ,  176  operate to seal the vaginal applicator  170  to the coupling device  100  to prevent leakage during product transfer between the coupling device  100  and the applicator  170 . In addition, the outlet end  172  of the vaginal applicator  170  engages the outer surface  114  of the male fitting when the applicator  170  is fully threaded and tightened to the coupling device  100 , thereby providing a further seal to prevent product leakage. 
     Referring again to  FIG. 1D , the cylindrical member  112  has an inner surface  118  that defines a tapered passageway  119 , which extends through the cylindrical member  112  of the male fitting  110  and the top wall  122  of the female fitting  120  to allow the male fitting  110  to fluidly communicate with an interior  140  of the female fitting  120 . The tapered passageway  119  tapers down in diameter moving from an outlet end  111  of the male fitting  110  towards the female fitting  120  to sealingly engage a tapered outlet end of an oral syringe thereby providing a leak resistant seal and retention of the syringe. The tapered passageway  119  has a taper of which can range from 1.00 degree to 20.30 degrees. In one preferred embodiment, the tapered passageway  119  has a taper of 5.03 degrees. 
       FIG. 4B  shows the coupling device  100  coupled with an oral syringe  180 . As shown, the tapered passageway  119  of the cylindrical member  112  of the male fitting  110  sealingly engages a tapered outlet end  182  of the oral syringe  280  to prevent leakage during product transfer between the coupling device  100  and the oral syringe  180 . 
     The coupling device  100  of  FIGS. 1A-1D  can be made of plastic and formed as a unitary one-piece member. 
     The coupling device  100  of  FIGS. 1A-1D  ensures consistent filling volume and prevents over-tightening and provides the following advantages over current methods for both filling and dispensing/dosing from vaginal applicators:
         Allows the compounding pharmacist to simply deliver the mixing jar, the newly invented coupling (which the pharmacist will screw onto the mixing jar with the appropriate standard industry cap included to seal it) and the vaginal applicators to the patient, eliminating the wasted product created by transferring to pumps, click dispensers or collapsible tubes.   By enabling the patient to fill easily and accurately their vaginal applicators, the pharmacist no longer has to fill collapsible tubes, or specialized pumps or click dispensers, saving the pharmacist tremendous amounts of time.   Eliminates the residual, wasted cream that cannot be recovered by the patient from pumps, click dispensers and collapsible tubes.   Provides a positive, consistent, and accurate connection point for the patient to dose and fill their applicators.   Reduces total cost by eliminating the need for pumps, click dispensers or collapsible tubes.   Unlike pumps/click dispensers, allows the prescribing doctor flexibility in changing dosages on the fly, using product already in the patient&#39;s possession.       

     In addition, the coupling device  100  of  FIGS. 1A-1D  provides connection of the mixing jar  150  to an outlet end of the oral syringe, which provides the following advantages over current methods for both filling and dispensing/dosing from oral syringes:
         Allows the compounding pharmacist to simply deliver the mixing jar, the newly invented coupling (which the pharmacist will screw onto the mixing jar with the appropriate standard industry cap included to seal it) and the oral syringes to the patient, eliminating wasted product created by transferring to pumps/click dispensers.   Provides a snug, sealed fit so that the pharmacist or patient can easily fill oral syringes with no leaks, waste or mess.   By enabling the patient to accurately and effectively fill his/her own oral syringes, saves a significant amount of pharmacist preparation and packaging time.   Eliminates the residual, wasted cream that cannot be recovered by the patient from pumps/click dispensers.   Provides a positive, consistent, and accurate connection point for the patient to dose and fill their syringes.   Reduces total cost by eliminating the need for pumps/click dispensers.   Unlike pumps/click dispensers, allows the prescribing doctor flexibility in changing dosages on the fly, using product already in the patient&#39;s possession.   Eliminates the need for a separate adapter to connect the mixing jar tapered nozzle to oral syringes. The tapered nozzle-to-adapter-to syringe connections are a cumbersome assembly for the pharmacist or patient with the following problems associated with this method of filling oral syringes: non-positive, inaccurate fit which can result in wasted material and/or introduction of air making dosing inaccurate, significant difficulty for the patient to “manipulate” the syringe to achieve an accurate dose, and an increase in the time required to fill a syringe for either the pharmacist or the patient.   Serves two purposes with one coupling: connecting the mixing jar to both vaginal applicators and to oral syringes.       

     Referring now to  FIGS. 2A-2D , there is shown a second embodiment of a coupling device  200  for coupling a mixing jar (e.g., EMP jar) to a Luer-Lock syringe or a Slip-Tip syringe. The coupling device  200  generally comprises a male fitting  210  and a female fitting  220 . 
     The female fitting  220  of the coupling device  200  comprises a planar circular top wall  222  and a cylindrical side wall  224  depending from a rounded peripheral edge  226  of the top wall  222 . The cylindrical side wall  224  of the female fitting  220  has an outer surface  228  and an inner surface  230 . The outer surface  228  of the side wall  224  includes a plurality of longitudinal scallops or grooves  232  which extend into the rounded peripheral edge  226  of the top wall  222  and aid in gripping the coupling device  200  when attaching a Luer-Lock or Slip-Tip syringe to the coupling device  200  and/or when connecting the coupling device  200  to the mixing jar  150  ( FIG. 3 ). 
     As shown  FIGS. 2D, 3, 5A and 5B , the standard female or internal thread  234  is provided on the inner surface  230  of the cylindrical side wall  224 . The female or internal thread  234  of the female fitting  220  is adapted to complement the male thread  158  provided on the male fitting  156  on the lid  152  of the mixing jar  150  ( FIG. 3 ). The internally threaded female fitting  220  allows the coupling device  200  to be screw-threaded onto the lid  152  of the mixing jar  150 . An inner surface  236  of the top wall  222  of the female fitting  220  defines a shoulder  238  above the internal thread  234  which is operative as a stop to ensure exact screw-tightening height and to prevent overtightening of the female fitting  220  of the coupling device  200  to the male fitting  156  of the mixing jar lid  152  ( FIG. 3 ). More particularly, the free end  160  of the male fitting  156  of the mixing jar lid  152  will abut against the shoulder  238  of the female fitting  220  when the coupling device  200  is properly screw-tighten to the male fitting  156  of the mixing jar lid  152 . The stop  238  is also operative as a seal to prevent leakage during product transfer between the coupling device  200  and the mixing jar  150 . 
     Referring again to  FIGS. 2A-2D , the male fitting  210  of the coupling device  200  is formed by a cylindrical member  212  extending up from the top wall  222  of the female fitting  220  and a standard Luer-Lock thread  216  provided on an outer surface  214  of the cylindrical member  212 . The cylindrical member  212  has an inner surface  218  that defines a tapered passageway  219 , which extends through the cylindrical member  212  and the top wall  222  of the female fitting  220  to allow the male fitting  210  to fluidly communicate with an interior  240  of the female fitting  220 . The tapered passageway  219  tapers down in diameter moving from an outlet end of the male fitting  210  towards the female fitting  220  to sealingly engage a tapered outlet end of a Luer-Lock or Slip-Tip syringe, thereby providing a leak resistant seal and retention of the syringe. The taper of the tapered passageway  219  ranges from 1.00 degree to 10.72 degrees. In one preferred embodiment, the tapered passageway  219  has a taper of 2.86 degrees. 
     As in the previous embodiment, the coupling device  200  can be made of plastic and formed as a unitary one-piece member. 
     As shown in  FIG. 5A , the Luer-Lock thread  216  of the male fitting  210  of the coupling device  200  allows a standard a Luer-Lock syringe  270  to be attached to the coupling device  200  by threadedly engaging the thread  216  of the male fitting  210  with an internal thread  276  of a female Luer-Lock fitting  274 , which surrounds a tapered dispensing tip  272  of the Luer-Lock syringe  270 . As the syringe  270  is threadedly engaged with the male fitting  210  of the coupling device  200 , the tapered dispensing tip  272  of the syringe  270  enters and sealingly engages the tapered passageway  219  of the male fitting  210  to prevent leakage during product transfer between the coupling device  200  and the Luer-Lock syringe  270 . Once fully threaded, the free end of the syringe&#39;s female Luer-lock fitting  274  engages the planar top wall  222  of the female fitting  220  of the device  200  to further insure against product leakage during product transfer between the coupling device  200  and the Luer-Lock syringe  270 . 
       FIG. 5B  shows the coupling device  200  coupled with a Slip-Tip syringe  280 . As shown, the tapered passageway  219  of the cylindrical member  212  of the male fitting  210  sealingly engages a tapered outlet end  282  of the Slip-Tip syringe  280  to prevent leakage during product transfer between the coupling device  200  and the Slip-Tip syringe  280 . 
     The coupling device  200  of  FIGS. 2A-2D  provides the following advantages over current methods for both filling and dispensing/dosing from Luer-Lock syringes:
         Provides pharmacists/patients with a more efficient and accurate way to fill Luer-Lock syringes directly from a mixing jar using a positive connection.   Provides a snug, sealed fit so that the pharmacist or patient can easily fill Luer-Lock syringes with no leaks, waste or mess.   Eliminates the need for a separate adapter to connect the mixing jar tapered nozzle to Luer-Lock syringes. The tapered nozzle-to-adapter-to syringe connections are a cumbersome assembly for the pharmacist or patient with the following problems associated with this method of filling Luer-Lock syringes: non-positive, inaccurate fit which can result in wasted material and/or introduction of air making dosing inaccurate, significant difficulty for the patient to “manipulate” the syringe to achieve an accurate dose, and an increase in the time required to fill a syringe for either the pharmacist or the patient.       

     In addition, because the coupling device  200  of  FIGS. 2A-2D  is constructed to provide for the connection of a mixing jar to the top of a Slip-Tip syringe, the following advantages are realized over current methods for both filling and dispensing/dosing from Slip-Tip syringes:
         Allows the compounding pharmacist to simply deliver the mixing jar, the coupling (which the pharmacist will screw onto the mixing jar with the appropriate standard industry cap included to seal it) and the appropriate Slip-Tip syringes to the patient, eliminating the wasted product created when transferring to pumps/click dispensers.   Provides a snug, sealed fit so that the pharmacist or patient can easily fill Slip-Tip syringes with no leaks, waste or mess.   By enabling the patient to accurately and effectively fill his/her own slip-tip syringes, saves a significant amount of pharmacist preparation and packaging time.   Eliminates the residual, wasted cream that cannot be recovered by the patient from pumps/click dispensers.   Provides a positive, consistent, and accurate connection point for the patient to dose and fill their Slip-Tip syringes.   Reduces total cost by eliminating the need for pumps/click dispensers.   Unlike pumps click dispensers, allows the prescribing doctor flexibility in changing dosages on the fly, using product already in the patient&#39;s possession.   Eliminates the need for a separate adapter to connect the mixing jar tapered nozzle to Slip-Tip syringes. The tapered nozzle-to-adapter-to syringe connections are a cumbersome assembly for the pharmacist or patient with the following problems associated with this method of filling slip-tip syringes: non-positive, inaccurate fit which can result in wasted material and/or introduction of air making dosing inaccurate, significant difficulty for the patient to “manipulate” the syringe to achieve an accurate dose, and an increase in the time required to fill a syringe for either the pharmacist or the patient.   Serves two purposes with one coupling: connecting the mixing jar to both Luer-Lock and Slip-Tip type syringes.       

     It should be understood that the invention is not limited to the embodiments illustrated and described herein. Rather, the appended claims should be construed broadly to include other variants and embodiments of the invention, which may be made by those skilled in the art without departing from the scope and range of equivalents of the invention. It is indeed intended that the scope of the invention should be determined by proper interpretation and construction of the appended claims and their legal equivalents, as understood by those of skill in the art relying upon the disclosure in this specification and the attached drawings.