Abstract:
A medicine cap with a timing mechanism that automatically resets upon the removal of the cap from a medicine bottle. A timing device is housed within a medicine camp, with a diaphragm housed below the timing device. The diaphragm has a rod extending upward from a central location, and fastening the cap onto a bottle or container causes the rod to be pushed up into contact with, and activate, the timing device. Upon removal of the cap from the bottle or container, the rod loses contact with the timing device, and the timer is reset. The cap may comprise multiple pieces, so the cap may be used in child-proof mode by the engagement and disengagement of splines on the cap housing and a cap insert. Means are supplied for enabling the constant engaging of the splines.

Description:
This application is a divisional application of U.S. patent application Ser. No. 11/457,631, filed Jul. 14, 2006 now U.S. Pat. No. 7,408,843, by Dennis Brandon, and claims benefit of U.S. Pat. App. No. 60/699,547, filed Jul. 15, 2005, by Dennis Brandon, and U.S. patent application Ser. No. 11/457,631, filed Jul. 14, 2006, by Dennis Brandon, and is entitled to those filing dates for priority. The disclosures, specifications and drawings of the above applications are incorporated herein by specific reference. 

   FIELD OF INVENTION 
   This invention relates generally to timers, and more particularly to medication timer mechanisms. 
   BACKGROUND OF INVENTION 
   The majority of medicines and drugs require administration in a series of doses at specific times over a period of time for increased effectiveness. Outside the hospital or clinic setting, this usually requires the patient or an individual caring for the patient to be responsible for keeping track of the taking of the medication in question. A frequent problem, however, is that the patent or individual keeping track often errs in the administration of the medication. Patients may forget to take a dose of their medication, be tardy in taking a dose, or forget taking a dose and take a second dose too soon. 
   A number of approaches to solving this problem are found in the prior art. There are a number of devices, for example, that comprise a pill case or box with a timer or alarm to alert the patient that a certain time period has passed and that medication should be taken. These devices, however, are not suitable for many types of medication that should not be transferred from their initial container, and also may lead to problems associated with mixed medications and accumulated toxicity. In addition, these simple alarms provide no means to ensure or check compliance with administration of the medication. Furthermore, if the patient does take the medication at the proper time, the patient may fail to reset the timer or alarm. 
   In response to these problems, a number of devices have been developed that incorporate the timing mechanism and alarm in the cap or lid of the medication bottle or container itself. Examples of such mechanisms are found in Wirtschafter (U.S. Pat. No. 5,233,571), Albeck (U.S. Pat. No. 5,313,439), and Walters (U.S. Pat. No. 5,751,661). Several problems still are found with these devices, however, including false resetting of the timer or alarm without the medicine cap ever being removed or the medicine taken, interruption of power to the timer, breach of the medication-containing compartment, interference with child-resistant mechanisms, and delicacy of the mechanisms leading to high failure rates. An additional problem is the high cost and complex assembly of many such devices, which prohibits their wide adoption and use. 
   Accordingly, what is needed is an automatic timing mechanism for a medicine cap that is reliable, stable, easy to assemble and operate, low in cost, and compatible with both child-resistant and non-child-resistant medication containers. 
   SUMMARY OF THE INVENTION 
   The present invention provides for a medicine cap with a timing mechanism that automatically resets upon the removal of the cap from a medicine bottle. In general, the present invention comprises means for calculating or measuring time with means for providing an alert when a particular time interval has elapsed. 
   In one exemplary embodiment, the timing means is a conventional solid state timing device mounted on a circuit board with one or more power sources, such as batteries. The circuit board is in contract with display means, such as an LED, mounted on a cap top insert component. The circuit board and cap top insert component are snap fit inside a cap exterior housing. A threaded insert component with a flexible diaphragm is snap fit below the circuit board, and a central rod on the diaphragm makes contact with the timing circuitry when the cap assembly is fastened onto a medicine bottle. Upon removal of the cap from the bottle, the central rod loses contact with the timing circuitry, and the timer is reset. 
   In another exemplary embodiment, the cap comprises a cap housing and a cap insert, each with matching splines that can be engaged and disengaged with the application of pressure so the cap may function in child-proof mode. Means are provided for causing the splines to be constantly engaged where child-proof mode is not desired. 

   
     DESCRIPTION OF THE DRAWINGS 
       FIG. 1  shows an exploded perspective view of the major components of a cap timing mechanism in accordance with an embodiment of the present invention. 
       FIG. 2  shows a perspective view of a circuit board and timer in accordance with an embodiment of the present invention. 
       FIG. 2   a  shows a perspective view of an alternative configuration of a circuit board and timer in accordance with another embodiment of the present invention. 
       FIG. 2   b  shows a side view of the circuit board and timer of  FIG. 2   a.    
       FIG. 3  shows a top view of the circuit board and timer of  FIG. 2 . 
       FIG. 3   a  shows a top view of the circuit board and timer of  FIG. 2   a.    
       FIG. 4  shows a perspective view of a cap top insert section in accordance with an embodiment of the present invention. 
       FIG. 5  shows a side view of the cap top insert of  FIG. 4 . 
       FIG. 6  shows a perspective view of the bottom of the cap top insert of  FIG. 4 . 
       FIG. 7  shows a close-up sectional view of one form of childproofing mechanism in accordance with an embodiment of the present invention, in childproof mode. 
       FIG. 8  shows a close-up sectional view of the childproofing mechanism of  FIG. 7 , in childproof mode with the splines of cap top insert and the cap exterior housing engaged. 
       FIG. 9  shows a close up section view of the childproofing mechanism of  FIG. 7 , in non-childproof mode. 
       FIG. 10  shows a perspective view of the cap exterior housing in accordance with an embodiment of the present invention. 
       FIG. 11  shows a top view of the cap exterior housing of  FIG. 10 . 
       FIG. 12  shows a perspective view of the bottom and interior of the cap exterior housing of  FIG. 10 . 
       FIG. 13  shows a perspective view of the threaded insert section in accordance with an embodiment of the present invention. 
       FIG. 14  shows a side view of the threaded insert section of  FIG. 13 . 
       FIG. 15  shows a top view of the threaded insert section of  FIG. 13 . 
       FIG. 16  shows a cross-section of an assembled unit in accordance with an embodiment of the present invention. 
       FIG. 17  shows a cross-section of an assembled unit in accordance with another embodiment of the present invention. 
       FIG. 18  shows a perspective view of an alternative configuration of the cap exterior housing and cap top insert in accordance with another embodiment of the present invention. 
   

   DETAILED DESCRIPTION OF THE INVENTION 
   Various forms of the standard medication container comprising a container and a cap is well known in the art. The container may contain medication in various forms. The top portion of the container typically contains threads or other means capable of engaging and securing the cap to the container. The container may vary in size, structure and configuration as necessary for differing medications, and the cap similarly will vary in size, structure and configuration to accommodate the different styles of containers. 
     FIG. 1  illustrates an exploded view of an exemplary embodiment of a medication timing apparatus in a cap in accordance with the present invention. The cap comprises a timing device  6 , preferably on a circuit board  12 , placed on a threaded insert section  40  and covered at least in part with a cap top insert section  20 , all of which is enclosed in a cap exterior housing  30 . 
   As seen in  FIGS. 2 ,  2   a ,  2   b ,  3  and  3   a , the cap contains means for measuring time, said means preferably comprising a timer  6  or similar device that measures time by means of an oscillating crystal or similar device. The timer  6  may comprise various components, including digital or analog components, and may be integrated in a circuit. In a preferred exemplary embodiment, the timer  6  comprises a microprocessor chip or a chip-on-board. The invention includes means for supplying power, such as one or more batteries  9  electrically connected to the timer  6 . In one embodiment of the present invention, removable tabs may be used in conjunction with the batteries to prevent power from being supplied to the timer  6 . The tabs are removed by the pharmacist, patient or other end-user when the timing cap is first activated. In another embodiment of the invention, a minimal level of power is always being supplied, allowing the actual time and other data (such as the number of times the cap has been removed) to be set and stored in memory. 
   In one exemplary embodiment, the invention includes means for providing a visual alert, such as an LED display or light  8 . In another exemplary embodiment, an alert can be provided by audible alert means. And in yet another exemplary embodiment, additional display means, such as an LCD display, can provide an alert message or other information, such as time elapsed or time remaining. 
   The timing components, including the batteries  9 , preferably are mounted on a circuit board  12 . The circuit board  12  is located underneath the cap top insert component  20 , and is in electrical contact with the visual alert means, such as the LED display or light  8 , or additional display means, which may alternatively be located in the cap top insert  20 . In an exemplary embodiment, as shown in  FIGS. 2 and 3 , the LED display or light  8  may be mounted on the circuit board  12  and extend to or upward through a matching hole  25  in the cap top insert  20 . Similarly, means for resetting the timer, such as a reset button or switch  14 , may be mounted on the circuit board  12 , with a matching hole  23  in the cap top insert providing access to the reset means  14 , or to which the reset means  14  may extend to or upward through. In yet another exemplary embodiment, a reset button or switch may be located on the cap top insert  20 , and be connected to the means for resetting the timer  14  located on the circuit board  12 . In another exemplary embodiment, as seen in  FIG. 2 , the circuit board  12  has all primary circuit components located on one side (which may be called the “top side”) of the board, although in other embodiments some components may be located on both sides. A hole  16  is located in or near the center of the circuit board  12  for purposes described below. 
   In a preferred embodiment, as seen in  FIGS. 4 and 18 , the cap top insert  20  comprises a flat circular outer disk section  22  with a raised central disk section  24 . The raised central disk section  24  contains the holes for the LED display or light  25  and reset button or means  23 . In an alternative embodiment, the central disk section  24  may contain the LED display or light itself, the reset button or means itself, or some combination of the above and holes. 
   A plurality of splines or tabs  26  are located around the circumference of the raised central disk section  24 . These splines or tabs  26  may selectively engage matching splines or tabs  32  on the interior of the cap exterior housing  30  when the cap is operated. The number, size and configuration of the splines  26  may vary, and may only be located at certain sections around the circumference of the raised central disk section  24 . The height of the splines  26  also may vary, and may extend to the height of the raised central disk section  24 , or only partway up, as shown in  FIG. 4 . Other engaging means also may be used. 
   In one exemplary embodiment, as shown in  FIGS. 4 ,  5  and  6 , the height of the splines  26  is lower than the height of the raised central disk section  24 . A circumferential groove  27  may be located in the side of the raised central disk section above the top of the splines  26 . A snap ring  28  or similar retaining ring or device may be placed around the raised central disk section to engage the circumferential groove  27  and hold the cap exterior housing  30  down so the splines  26  of the cap top insert  20  engage the matching splines  32  of the cap exterior housing  30 . The snap ring  28  may be flat or round, and may come in several colors to draw attention to its presence. If the snap ring  28  is left on, the cap functions in non-childproof mode. 
   If the snap ring  28  is removed, the cap functions in childproof mode as the cap exterior housing  30  must be pressed down for the splines  26 ,  32  to engage. One or more spring tabs  29  are located on the top of the flat circular outer disk section  22  between the outer edge of the disk and the splines  26 . The spring tabs  29  act to press the cap exterior housing  30  up and away from the cap top insert  20  a sufficient distance to disengage the splines  26 ,  32  and with sufficient force so that a child should not be able to cause the splines to engage. The spring tabs  29  may be molded as integral parts of the cap top insert  20 , or may be mounted thereon. 
   In an alternative exemplary embodiment, as shown in  FIGS. 7 and 8 , a rounded protrusion  97  is located on the outside of the raised central disk section  24  above the top of the splines  26 , in the approximate place of the circumferential groove  27 . A matching protrusion  98  and groove  99  is located on the inside rim of the cap top insert  20  above the cap top splines  32 . The protrusions  97 ,  98  are of sufficient size so that they come into contact and cannot pass each other (i.e., the cap exterior housing protrusion  98  remains above the central disk protrusion  97 ) unless sufficient downward pressure is applied to the cap exterior housing  30 . The protrusions  97 ,  98  also are located a sufficient distance apart and placed so that the splines  32  of the cap exterior housing  30  can engage the matching cap top insert splines  26  while the central disk protrusion  97  remains below the cap exterior housing protrusion  98 . When used with the spring tabs  29  as described above, the cap used in this way functions in childproof mode, as seen in  FIG. 8 , as downward pressure is required to cause the splines  26 ,  32  to engage and enable the cap to be turned and removed. With additional downward pressure, the cap exterior housing protrusion  98  may be forced over and below the central disk protrusion  97 , which becomes engaged with the groove  99 . This causes the splines  26 ,  32  to remain engaged and the cap thus to function in non-childproof mode, as seen in  FIG. 9 . The cap may be returned to childproof mode by forcing the cap exterior housing protrusion  98  up and over the central disk protrusion  97 . 
   In yet another alternative exemplary embodiment, one or more small tabs or protrusions may be located in the spaces between two or more of the splines  26  of the cap top insert  20 . The protrusions are located at a sufficient distance below the top of the cap top insert splines  26  so that the matching splines  32  of the cap exterior housing  30  can engage the cap top insert splines  26  without passing over the protrusions. When used with the spring tabs  29  as described above, the cap used in this way functions in childproof mode. However, with sufficient downward pressure on the cap exterior housing  30 , the splines  32  of the cap exterior housing  30  may be forced down and over the protrusions, causing the splines  26 ,  32  to remain engaged and the cap thus to function in non-childproof mode. The cap may be returned to childproof mode by forcing the splines  32  of the cap exterior housing  30  up and over the protrusions. 
   A plurality of flanges  21  extend downward from the outer circumference of the flat circular disk section  22  of the cap top insert  20 . In one exemplary embodiment, as shown in  FIG. 2 , there are four flanges  21 , with two pairs of flanges  21  on opposite sides. An inwardly-extending ridge  31  is located along the inside bottom edge of each flange  21 . The ridges  31  engage a matching groove  43  around the top of the threaded insert section  40  of the cap to secure the cap top insert  20  to the threaded insert section  40 . The flanges  21  exert sufficient force to cause the cap top insert  20  and the threaded insert section  40  to rotate together during normal operation of the cap. In another exemplary embodiment, the matching grooves  43  extend only partway around the threaded insert section  40  to match the width and possibly the number of the flanges  21 . This arrangement helps ensure that the cap top insert  20  and threaded insert section  40  rotate together during normal operation of the cap. 
   As seen in  FIGS. 13-15  and  17 , the threaded insert section  40  is cylindrical with a diameter substantially equal to the diameter of the cap top insert  20 . The bottom end of the threaded insert  40  is open. The interior of the bottom end of the threaded insert  40  contains engaging means such as threads  41  that engage matching threads around the top of the medicine bottle. A flat sealing disk  42  is located inside of the threaded insert  40  above the top of the threads  41 . The diameter of the sealing disk  42  is fractionally smaller than the interior diameter of the threaded insert  40 , and provides a sealing contact with the top of the medicine bottle when the cap and bottle are closed. 
   The top end of the threaded insert  40  comprises a flexible diaphragm  44  extending down and into the threaded insert  40 . The bottom center of the diaphragm  44  contacts the center of the sealing disk  42 , helping to hold the sealing disk  42  in contact with the top of the medicine bottle when the cap and bottle are closed. 
   A rod or post  45  is located in the center of the diaphragm  44 , and extends up to the circuit board  12 . The rod  45  may be integrated with the diaphragm  44 , and be molded as a part thereof. If non-conductive material, the rod  45  pushes a contact switch in the circuit board  12 . The rod  45  may be capped in whole or in part with metal, in which case the rod  45  comes into contact with two contact points in the circuit board  12 . The rod  45  may also be a separate piece attached to the center of the diaphragm  44  by attachment means. In one exemplary embodiment, the rod  45  itself is made of metal or a conductive material, and may be attached to the diaphragm  44  by any suitable means, such as hole or socket molded in the diaphragm  44  to receive an end of the rod  45 . 
   When the cap is fastened on the top of the bottle, such as when being stored, for example, the diaphragm  44  is pushed up, thereby pushing up the rod or post  45  through the central hole  16  in the circuit board  12 , as seen in  FIG. 16 , to push a contact switch or come into contact with two contact points, as described above. While in this mode, the batteries are supplying power to the circuit and the timer is counting down to the appropriate time for the next dosage of medicine. In one alternative embodiment, as seen in  FIGS. 2   a ,  2   b , and  3   a , the rod or post  45  pushes up a rectangular or plate-like switch  15  on one side so that it is no longer touches a contact switch or contact points on the circuit board  12 . In another embodiment, as described above, the rod or post  45  is made of, or is capped or coated with, metal or a conductive material, and comes into contact with two contact points on the circuit board  12 . When the appropriate time has elapsed, an alert signal(s) is given. As disclosed above, alerts can be visible, audible, or both. The patient or user then removes the cap, which releases the pressure on the diaphragm  44  from the bottle, which in turn causes the rod  45  to move down and away from contact with the timing circuit  6 . This resets the timer. In the one alternative embodiment described above, this may be accomplished when the switch  15  moves down and touches the contact on the circuit board  12  in response to the rod  45  movement. The end of the switch  15  away from the hole  16  may be affixed to the circuit board  12  in a variety of ways, leaving the end above the hole  16 , in whole or in part, free to move up and down in response to movement of the rod or post  45 . In the other alternative embodiment, this is accomplished when the rod  45  moves out of contact with the contact points. 
   In one exemplary embodiment, the top end of the threaded insert  40  comprises one or more inset sections  49  of smaller diameter than the threaded insert  40 . The outer part of these sections  49  contain a groove  43  used to secure the cap top insert  20  by means of the flanges  21 . In one exemplary embodiment, as seen in  FIG. 13 , the grooves  43  extend only partway around the circumference of the threaded insert section  40  to match the width and possibly the number of the flanges  21 .  FIG. 13  shows an arrangement where two grooves  43  are located on opposite sides of the threaded insert section  40 , each groove  43  sized to engage two adjacent flanges  21 . This arrangement helps ensure that the cap top insert  20  and threaded insert section  40  rotate together during normal operation of the cap. 
   As seen in  FIGS. 10-12  and  18  the cap exterior housing  30  is cylindrical. In one exemplary embodiment, the outside of the housing  30  may be ridged or grooved  31  to facilitate a better grip by the user. The interior diameter of the cap exterior housing  30  is slightly larger than the exterior diameter of the top insert  20  and the threaded insert  40 , so that the top insert  20  and threaded insert  40  fit snugly within the cap exterior housing  30 , but can move freely therein. In one exemplary embodiment, the interior of the bottom end of the cap exterior extends slightly inward to provide a shallow lip  60  to hold the threaded insert  40  inside the cap exterior housing  30  once inserted. 
   The top end of the cap exterior housing  30  has a section  62  extending substantially inward, which assists in retaining the cap top insert. The interior diameter of the rim-like section of the top end  62  is slightly larger than the diameter of the raised central disk section  24 , so the raised central disk section  24  can extend up and through the open center or aperture  68  of the top end. The cap exterior housing splines  32  that engage the matching splines  26  around the raised central disk section  24  are located on the underside of the rim-like section of the top end, along the inside edge. In an exemplary embodiment, the outermost edge  66  of the top end is raised for more convenient operation by the user. 
   In one exemplary embodiment, the present invention may be quickly and easily assembled at the factory or other workplace with minimal effort and a low failure rate. A typical assembly may consist of the following steps: the circuit board (including batteries with tabs, if any) is fastened to the cap top insert; the threaded insert is fastened to the cap top insert below the circuit board; the sealing disk is inserted into the threaded insert; and the resulting unit is inserted into the cap top housing. These steps may be in a different order in whole or in part; for example, the sealing disk may be inserted into the threaded insert after the unit comprising the circuit board, cap top insert, and threaded insert is inserted into the cap top housing. In an embodiment where a snap ring is used, the snap ring is then placed on the circumferential groove on the cap top insert. The assembled unit may then be shipped. In configurations where power is constantly supplied, the microprocessor chip can be placed in sleep mode in order to conserve power. This also allows the assembled unit to be tested at the factory or during shipping. A standby or low power mode also may be available. 
   In another exemplary embodiment, the first operation of the assembled unit, which typically is stored separately from the medicine bottle, proceeds as follows: the medicine bottle is filled with the appropriate amount of medicine; the battery tabs, if any, on the assembled unit are removed; the assembled unit is fastened onto the bottle, causing the rod on the diaphragm to be pushed up and into contact with the timing circuit; and the timing apparatus is in operational mode and ready for the time or time period to be set. 
   In one exemplary embodiment, setting the time period may be accomplished by holding down the reset button or switch for a certain period of time (e.g., 3 seconds), pressing the reset button or switch a certain number of times in succession, or a combination of the above. A sound or visual signal can be provided to indicate when the setting operation has been successful. 
   Typical time periods include, but are not limited to, once per day, twice per day, three times per day, and four times per day. The exact number of hours in each period may vary in accordance with accepted medical practice to encompass sleep periods and the like. In configurations where power is constantly supplied to the microprocessor or timing circuitry  6 , and actual time can be stored in memory, these time periods can all be established for particular times, and not calculated relative to the last reset or cap removal. Thus, in one embodiment, a variation in the time when one dose of medicine is taken, or even the missing of a dose, will not vary the time when the next dose of medicine should be taken. 
   In another embodiment, the microprocessor or timing circuitry  6  may apply simple logic to determine whether the act of opening the bottle was intentional. For example, if the cap was removed before less than half of the set time period has expired since the last valid removal, the device assumes that the removal was a mistake, and does not reset (i.e., it will still give an alert at the end of the time period). If the cap is removed when at least half of the set time period has expired, however, the device assumes that the removal was intentional and that the dose of medicine scheduled to be taken at that end of that time period has been taken. The device then resets. Thus, for example, if the time period is 24 hours, removal of the cap within the first 12 hours of the time period will not cause a reset, but removal of the cap between 12 and 24 hours will cause a reset. In another exemplary embodiment, a sound or visual signal can acknowledge the removal and replacement of the cap on the bottle, and indicate that the timer has been reset for the next time period. This configuration is especially useful in conjunction with the above method of determining whether the removal of the cap was intended for the purpose of taking a dose of medicine. 
   The use of the microprocessor allows great flexibility with regard to customizing various aspects of the present invention. Customization may be done by the supplier, drug store, pharmacist, physician, or patent. 
   In yet another embodiment, the device may presume that enough medicine is being supplied for only a certain time period, and give a warning or alert when that time period is about to expire to remind the patient to get the prescription refilled. The device would then stop operating a few days or so after the expiration of that time period. For example, if the prescription is refilled on a monthly basis, the device can beep or flash continuously or on an intermittent basis after 27 days to remind the patient to get the prescription refilled. And the device would stop operating after 33 days. 
   Thus, it should be understood that the embodiments and examples have been chosen and described in order to best illustrate the principles of the invention and its practical applications to thereby enable one of ordinary skill in the art to best utilize the invention in various embodiments and with various modifications as are suited for particular uses contemplated. Even though specific embodiments of this invention have been described, they are not to be taken as exhaustive. There are several variations that will be apparent to those skilled in the art. Accordingly, it is intended that the scope of the invention be defined by the claims appended hereto.