Patent Document

CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application is the National Phase of International Application PCT/US2015/043834 filed Aug. 5, 2015 which designated the U.S. and that International Application was published in English under PCT Article 21(2) on Feb. 11, 2016 as International Publication Number WO2016/022704A1. PCT/US2015/043834 claims priority to U.S. Provisional Application No. 62/033,579, filed Aug. 5, 2014. Thus, the subject nonprovisional application claims priority to U.S. Provisional Application No. 62/033,579, filed Aug. 5, 2014. The disclosures of both applications are incorporated herein by reference. 
     
    
     BACKGROUND OF THE INVENTION 
       [0002]    This invention relates to a device for use by diabetics and other medical patients who must use hypodermic needles to inject medication at home or on-the-go with the use of medication delivery pen commonly referred to as an “EpiPen” or an insulin pen. These medication delivery pens contain a large amount of medication with a dial to select a small portion of that medication to be used in a single dosing. To use an insulin pen, a disposable pen needle is screwed in, used, then unscrewed and removed from the medication delivery pen. The disposable pen needle has a thin removable foil backing in order to keep the needle sterile until use. This backing is removed leaving the end of the cap-covered pen needle that is to be screwed into the medication delivery pen exposed. This end is screwed into the end of the medication delivery pen (or insulin pen) and the cap covering the needle inside is then removed to leave a needle exposed and attached to the medical delivery pen. The patient then dials the precise amount of insulin or other medication needed with a dial on the medical delivery pen and injects the medication. The needle is then recapped and unscrewed from the medication delivery pen, leaving the patient with both the foil covering for the back of the needle and the contaminated pen needle itself. The patient takes this medication when they are hyperglycemic (high blood glucose). 
         [0003]    As well, to know whether or not to give an insulin injection, do nothing, or consume glucose/carbohydrates, diabetics must monitor their blood glucose using a blood glucose monitor. This monitor tells them if they are hyperglycemic (high blood sugar requiring dieting, exercise or the injection of insulin) or hypoglycemic (low blood sugar requiring the diabetic to ingest glucose/carbohydrates). There are currently two primary forms of blood glucose monitor systems. One form, referred to as the “traditional” form has three common necessary devices associated with it. The traditional style glucose monitor system requires disposable blood testing strips in a holding container, a finger lancing device to draw blood, and a monitor to put the testing strip into and read the blood glucose. The second method is a constant glucose monitor that checks the blood glucose at regular intervals using a patch that has a probe. The probe sits subcutaneously and reads blood glucose, sending the results to a blood glucose monitor. The final necessary component that a diabetic must carry besides a glucose monitor and insulin is then some form of carbohydrate or glucose with them in order to raise their blood sugar if they are hypoglycemic (low blood glucose). This comes in the form of candy or blood glucose tablets most often. 
         [0004]    With both the glucose monitor and the insulin pen there comes considerable medical waste in the form of contaminated insulin pen needles, lancets, and test strips. These all constitute medical waste and pose a considerable risk to public safety due to risk of exposure to blood borne pathogens, especially considering the prevalence of diabetes and the millions of people using these medical devices. The problem becomes that while hospitals necessitate the proper disposal of any contaminated sharps, in personal use these pen needle caps and other contaminated medical wastes are often times left around in houses, cars, pockets, and bags since there lacks a way to easily dispose of these products on-the-go. In addition to this, when pen needles are not disposed of immediately following use patients will often times reuse the needles since they are readily available. This poses a risk to the patient and may cause accidental exposure to blood borne pathogens in the environment around the patient. 
         [0005]    It is also important to note the logistics of a diabetic or other medication delivery pen using patient&#39;s devices that they carry with them. Medication delivery pens, due to their smooth, straight, and rounded nature often times fall out of pockets, bags and purses. The same goes for the unused pen needles that are freely scattered throughout pockets and purses making them also easily fall out. If pen needles do stay in a bag or purse, they may also be hard to find since they are small and can easily hide among the numerous other products in the purse or bag. 
         [0006]    Diabetics and other patients using these pens are also burdened due to the need to carry a number of medical devices with them daily. As individuals, even non-diabetics often carry a wallet or purse, keys, and a cell phone in daily life. Diabetics must also then carry some form of glucose/carbohydrate, a glucose monitor, their insulin pen, and insulin pen needles. This is seven items needed daily, and this is without a way to properly dispose of the medical waste. Currently, many diabetics leave necessary devices at home because of the inconvenience of carrying all the devices necessary for proper blood glucose management. The addition of any extra medical device would be a further burden and likely cause them not to use such a device. The pairing of these devices together into one device that can be easily carried then lessons the chances that one device will be left, forgotten, lost, or otherwise not available for use when a diabetic needs it. As well, it is important to offer the diabetics options in the manner that they may carry the devices, since everyone has preferences and individual lifestyles that they mold to fit around the way they manage their disease. 
       SUMMARY OF THE INVENTION 
       [0007]    The base device of this invention looks to solve the problems relating to injecting with the insulin pen and the medical waste created by diabetes. In one embodiment, it is a disposable device that allows the patient to both store pen needles and properly dispose of all medical waste associated with diabetes or other diseases requiring a medication delivery pen. The base device of the invention would do so without the burden of carrying any extra medical device. It would do so by attaching directly to the medication delivery pen itself in replacement of the medication delivery pen&#39;s cap, with the sharps container and unused pen needle dispenser hanging on one side of the pen. This would be done in such a way as to add little to its noticeable carrying size of the medication delivery pen. This portion of the invention would be as long as the pen itself, add just slightly more to the width of the pen than a medication deliver pen needle laid horizontally, and would be just slightly larger in depth than the diameter of the original pen and needles. This would be the base of the entire invention with a glucose monitor and/or glucose tablets attaching to this device at the discretion of the diabetic. It would allow diabetics a disposable device that carries both the unused needles necessary to make an injection and a disposal area for contaminated pen needles, lancets, test strips, and any small materials associated with diabetes and diabetic devices. There is no prior devices or ideas filed that attach a sharps container, disposal container, or pen needle storage device to the pen in replacement of its pen cap. As well, there is no system that attaches to the pen that preferentially stores the needles horizontally. 
         [0008]    This invention then also features removable additions to allow for both a folding blood glucose monitor or constant glucose monitor and glucose tablets/candy so that the diabetic has the option of carrying all necessary devices and materials related to diabetes in one pocket sized device. These additions would attach to the unused needle holder and disposal container by clipping onto the replacement pen cap opposite the disposal container/unused needle dispenser or separately via their own pen cap replacement. The optional attachment options featured in the invention are a folding glucose monitor, constant glucose monitor, or glucose tablets/candy. Each of the attachments can be attached individually to the unused needle holder/disposal container. 
         [0009]    The glucose tablets/candy will also features a second identical clip as the one it attaches to on the outside of the glucose tablets/candy that allows for either the folding glucose monitor or constant glucose monitor to be attached to the outside. When all three devices are together the glucose tablets/candy attachment then sits in between the disposal container/unused needle holder and the glucose monitor of choice. As well, when all three devices are put together (the disposal container/unused needle holder, constant or foldable glucose monitor, and the glucose tablets/candy) then all devices needed to check blood sugar and properly take care of hyperglycemia or hypoglycemia are in one device. The glucose tablets/candy can also be attached to just the glucose monitor. There is currently no device that combines any and certainly not all of these devices in such a way. 
         [0010]    The disposal container and pen needle dispenser cap features a double-dispensing method of carrying unused needles that both allows for two differing methods of dispensing needles. This allows for an affordable method of production since the hinged door used allows the invention to be produced in only two mold cavities. Making the device as low cost as possible to manufacture is necessary for the device to be disposable. This is the minimum necessary cavities needed to manufacture this device since the cap of the invention can be produced with a different plastic than the body to allow the teeth to flex and allow used needles to fall through. This makes the invention inexpensive to produce. 
         [0011]    The first method of dispensing involves the medication delivery pen being removed as it would be to take a shot. In order to load the needles the pen is flipped upside down as it is removed, exposing a hole in the very posterior of the invention on the side that runs along the medication delivery pen. The needles are fed into this hole, pointed end first so they poke through the opening opposite of the hole, with the side with the plastic covering that keeps the needle sterile entering last. The needles are stacked inside similar to how shotgun shells are loaded, with the pointed end facing away from where the medication delivery pen would be and the needles lying horizontally. No prior device that attaches to the insulin pen to hold the pen needles stacks them horizontally. In order for this to be accomplished the end opposite of the opening in the posterior also has a triangular opening that runs along the hinged door that is smaller than the foil end of the unused pen needle so the pointed end of the needles may stick out, but not fall out since that opening is not as large as the diameter of the pen needle&#39;s largest side. The medication delivery pen is then replaced and this keeps the needles from falling out before use. 
         [0012]    When the pen is to be used the user removes the pen and angles the invention so an unused pen needle falls out the hole that is now exposed since the medication delivery pen is no longer present to stop it. A new needle then falls into the place of the needle that has just been dispensed due to gravity and is ready for use. The medication delivery pen and pen needle are then used. The pen is replaced and the hole is covered. The user then dispenses the pen needle and coverings into the sharps container into the top of the device under the angled lid and disposes of them. 
         [0013]    In the second method of dispensing unused needles involves the medication delivery pen staying in place. The user flips the device upside down, uses their thumb to open the living hinge door at the bottom of the device that is adjacent and opposite to the opening described in the previous dispensing method. Once the door is opened, the needles are placed inside again with the pointed end of the needles facing away from the medication delivery pen, horizontally. The door is then closed allowing the pointed ends to again stick through the opening on the door itself. 
         [0014]    This opening on the door starts smallest at the top of the unused needle containment area and generally gets wider towards the bottom, with plastic teeth along the opening. This is for two reasons. The first is that the door angles back towards the pen needle, requiring more of the triangular shaped pen needle to stick out of the door. The second and main purpose of this is to allow for the needle at the very bottom, where the opening is only slightly smaller than the needle due to the plastic teeth in the opening, to be pulled through these teeth as they flex slightly. 
         [0015]    This method is meant to have unused needle dispensing be similar to grabbing a number to wait in line at a restaurant or butcher shop, making it natural and easy to use. The needle is pulled through the teeth and in its place, gravity again causes a new needle to fall down and replace it. It is important to note that any loading or dispensing method may be used at any time to the user&#39;s preference. The order listed in here is to make the device&#39;s functions easy to understand and visualize. Also, the depth of the device is only slightly larger than the diameter of the pen needles, forcing the needles to lie horizontally in the unused needle containment area and horizontally or vertically in the sharps containment area. It is preferable that they not lie cross with the length of the device. 
         [0016]    Once the pen needle, lancets, tests strips, or other contaminated medical products have been used the user then will open the lid to the sharps container located at the top of the invention. This sharps container features an angled lid that serves a few purposes. The first purpose is the angle to the lid opens and fits naturally under the user&#39;s thumb as the needle is inserted. This is meant to be a good use of ergonomics and is important to the acceptance of the device. The needle is to be placed under the opened lid and on top of the plastic teeth with the pointed end closest to the hinge so it is on a downward angle. The second purpose of the lid is to increase the length of the hole through which the needle is pushed through since the width of the containment area (width being from the side that runs along the length of the medication delivery pen, to the side opposite that has the triangular opening in at the lower end) is only very slightly longer than the length of pen needle. The angle uses the concept of Pythagorean&#39;s Theorem (basic geometry) to increase the length of opening. The user then also puts any extra smaller pieces to the pen needle (such as the foil) or any contaminated waste medical products that can fit underneath the lid with the pen needle. 
         [0017]    The user then presses down on the top of the lid in a natural motion to close the lid, with the lid protecting his or her thumb. The lid may feature a groove for the user&#39;s thumb so their thumb does not to slip out and this groove assists in pushing the pen needle, lancets, or test strips through the plastic teeth into the containment area. Once this motion is executed, the lid seals tightly and securely until it is opened again and all contaminated medical products are kept permanently in the containment area by the flexible plastic teeth. The angle to the lid then serves to assist in the needle preferentially falling horizontally into the containment area as the smaller end of the needle (the non-foil side) hits first and breaks the fall of the needle. The inventor in testing different methods found that this was the best way to get the needles to fall horizontally, since when dropped perfectly horizontally the larger back end of the pen needles had a tendency to bounce more causing them to land upright. 
         [0018]    While horizontal containment is preferable, it may be difficult to ensure this configuration. The containment area accounts for this due to the diameter of pen needles being a 1:2 ratio to their length. The containment area is only slightly larger in depth than the diameter of the needles and only slightly longer in width than the pen needle&#39;s length, meaning they will fall either upright or horizontally. If they fail to fall horizontally, the 1:2 ratio of diameter to length means that two needles stacked vertically occupy the same space in the containment area as two needles that fell horizontally, ensuring the most efficient use of space in the containment area. 
         [0019]    The first attachment to the disposal container/unused needle holder is then a folding glucose monitor that both holds test strips and has a lancing device at the bottom. The monitor can be attached or detached from the device via the top half of the folding device (the monitor itself). The second half of the device features a glucose testing strip holder at the top of the lower half and a lancing device at the bottom of the lower half. The device is designed to be detached and be either left in a straight line similar to that of the insulin pen or fold in half. Since the depth of the glucose monitor is the same throughout the device (see  FIG. 1C  for a reference indication of depth), when folded it is then a perfectly flat and compact all-in-one glucose monitor. If folded, it can easily attach as a key chain or slide into pockets that are not as deep. If kept straight it more easily slides into longer pockets or bags and it resembles the insulin pen itself. The design both minimizes the space needed to carry all three parts necessary to the glucose monitor and features two different ways to carry the device to maximize convenience to the user. 
         [0020]    This detachment of this portion of the invention allows the user to have the option of having one larger device or separate into two smaller devices (glucose monitor/test strips/lancing device and the needle holder/disposal): one to be carried in each pocket or as the patient wishes. If the user has an issue with losing devices, has a large pocket or bag to carry the device, or otherwise wants to easily keep track of all devices (the insulin pen, needles, disposal, and glucose tablets) they can choose to attach them all together. If they wish to separate the devices to fit one in each pocket, they have that option as well. This gives the user the most flexibility to fit this device into their daily life while pairing together devices that go together. 
         [0021]    The folding glucose monitor takes three separate devices and pairs them together into one device. Before, these three devices were often times kept in a purse-like bag that held the monitor, lancing device, and test strips: each one a separate piece. With this design, they are all in one device that uses design to make the most efficient use of space. 
         [0022]    As well, the pen needles (new and used) and the insulin pen used to be separated and scattered. With the base device to this invention, they are kept with the insulin pen itself. This way the insulin pen has everything needed to make an injection and dispose of used pen needles. Since this portion of the device (the sharps container and unused needle holder) is new, novel and not currently carried with diabetics, it is important to offer the other pieces to which the diabetic may already have strong preferences as attachments. This is because diabetics are often times loyal to the brands they have been using, and are not likely to give up a glucose monitor they have been using for years. This again leaves options open for individual preference. 
         [0023]    The design of the glucose monitor at the top of the device, the testing strip holder in the middle, and the lancet at the bottom is the ideal design for both the device folded and unfolded. When used, the test strip to the glucose monitor and the lancing device for one&#39;s finger face outward giving easy access. When the attachment is straight, this means that the user lances their finger at the bottom of the device and easily moves it to the top of the device to the inserted test strip. As well when the device is folded, the user needs to just move their finger slightly since the lancing opening and the test strip are right next to one another. Also when folded, the glucose testing strip holder is at the top of the device for the user to most easily remove the blood glucose test strips. The combination of all three devices into one attachment, the layout of the devices in the attachment, and the folding action of the entire device are all unique qualities not seen in any prior devices. 
         [0024]    The second attachment available to connect to the disposal container/unused needle holder is a second type of glucose monitor called a constant glucose monitor. A constant glucose monitor is the future of diabetic sugar monitoring since it tracks sugars at regular intervals giving the most information as to the rising or falling of sugar levels throughout the day. The constant glucose monitor would be single device that sends and receives signals to a probe in the form of a patch on the diabetic. It would attach at the same attachment point as the folding glucose monitor and would be a single body piece to receive signals from the probe, process them, and send them to the diabetic. The advantage over other constant glucose monitors is that it attaches to the insulin pen via the cap and the base invention. The fact that this glucose monitor attaches to the base device (disposal container and unused needle holder that attaches in replacement of the medication delivery pen&#39;s cap) means that it also attaches to the insulin pen via a replacement cap by proxy. 
         [0025]    The final attachment is glucose tablets or candy. The glucose tablets serve to raise a diabetic&#39;s blood glucose if they are suffering from hypoglycemia (low blood sugar). This candy attaches at the same attachment point as the glucose monitors and features an identical attachment point on the outside of the glucose tablets/candy so that the glucose monitor of choice by the diabetic can be attached as well, putting all necessary items to manage blood glucose in one device. As well, the glucose tablets/candy can be attached to just the glucose monitor of choice if the user wishes. 
         [0026]    Putting the glucose tablets in the center of all three devices (glucose monitor, glucose tablets, and the disposal container/unused needle holder) is important because it allows the diabetic to access the two things they use most, the insulin needles/disposal and blood glucose testing. As well, it allows the diabetic to remove or attach the devices as they choose with the most freedom. It also allows the diabetic to always have glucose tablets with them no matter what other device they are carrying since hypoglycemia (low blood glucose) is the most dangerous immediate threat to a diabetic&#39;s life. An important note to be made is the fact that the glucose tablets/candy attaches to the base device (disposal container and unused needle holder that attaches in replacement of the medication delivery pen&#39;s cap) this means that it also attaches to the insulin pen via a replacement cap by proxy. 
         [0027]    Various aspects of this invention will become apparent to those skilled in the art from the following detailed description of the preferred embodiment, when read in light of the accompanying drawings. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0028]      FIG. 1A  is a front view of the base device shown with three unused needles and without a lid. 
           [0029]      FIG. 1B  is a side angle view of the base device with the lid and three unused needles. 
           [0030]      FIG. 1C  is a front view of the base device shown with three unused needles and the lid. 
           [0031]      FIG. 1D  is a top view of the base device shown without a lid. 
           [0032]      FIG. 1E  is a top view of the base device shown with the lid. 
           [0033]      FIG. 2  is a side view of the empty base device with a medication delivery pen inserted with the base device being rotated and the medication delivery pen being removed. 
           [0034]      FIG. 3  is a side view of the empty base device shown with an unused pen needle being loaded without the medication delivery pen inserted. 
           [0035]      FIG. 4  is a side view of the base device with three unused pen needles loaded and the medication delivery pen being reinserted into its cap. 
           [0036]      FIG. 5  is a side view of the base device with the three unused pen needles and the medication delivery pen shown being removed. 
           [0037]      FIG. 6  is a side view of the base device showing an unused pen needle being dispensed without the medication delivery pen and the remaining needles falling into place. 
           [0038]      FIG. 7  is a side view of the empty base device shown with the medication delivery pen inserted and the base device being rotated. 
           [0039]      FIG. 8  is a side view of the base device showing the base device inverted with the medication delivery pen inserted and a thumb opening the bottom hinged door to allow unused needles to be placed inside. 
           [0040]      FIG. 9  is a side view of the base device with the medication delivery pen inserted showing the thumb closing the hinged door to keep the unused pen needles contained in the dispensing area. 
           [0041]      FIG. 10  is a side view of the base device with the medication delivery pen inserted showing the user removing an unused insulin pen needle through the teethed opening at the bottom of the dispensing area. 
           [0042]      FIG. 11  is a side view of the base device with the medication delivery pen inserted showing the remaining pen needles falling into place after one has been removed. 
           [0043]      FIG. 12  is a side view of the base device with the medication delivery pen inserted showing a thumb opening the lid to the sharps containment area and a used need being placed in the pre-containment area. 
           [0044]      FIG. 13  is a side view of the base device with the medication delivery pen inserted showing the thumb pressing the used needle through the flexible plastic teeth and into the sharps containment area. 
           [0045]      FIG. 14  is a side view of the base device with the medication delivery pen inserted showing the thumb completing the containment action with the lid closed and the pen needle falling horizontally inside. 
           [0046]      FIG. 15  is a side view of the base device with the medication delivery pen inserted showing a full base device with both used and unused needles, along with illustrating that two horizontal pen needles taking up the same space as two vertical needles. 
           [0047]      FIG. 16  shows a side view of the base device with the folding glucose monitor attachment. 
           [0048]      FIG. 17  shows a rear view of the base device with the folding glucose monitor attachment. 
           [0049]      FIG. 18  shows a side view of the base device with the folding glucose monitor attached and the door to the glucose testing strip holder being opened. 
           [0050]      FIG. 19  shows a side view of the base device with the folding glucose monitor attached and the door to the glucose testing strip holder being opened, and test strip being pulled out. 
           [0051]      FIG. 20  shows a side view of the base device with the folding glucose monitor attached, the glucose testing strip being put into the glucose monitor, and the door to the glucose testing strip holder being closed. 
           [0052]      FIG. 21  shows a side view of the base device with the folding glucose monitor attached, a glucose test strip in the glucose monitor, and the lancing device pricking the user&#39;s finger to draw blood. 
           [0053]      FIG. 22  shows a side view of the base device with the folding glucose monitor attached as the user puts a sample of their blood to the test strip in the folding glucose monitor in order to obtain the blood glucose of the user. 
           [0054]      FIG. 23  shows a side view of the base device with the folding glucose monitor attachment being removed from the base device to be used separately. 
           [0055]      FIG. 24  shows a side view of the folding glucose monitor attachment as it is folded. 
           [0056]      FIG. 25A  shows a side view of the folded folding glucose monitor as the door to the glucose testing strip holder is being opened. 
           [0057]      FIG. 25B  shows a side view of the folded folding glucose monitor as the user pulls a glucose test strip from the glucose testing strip holder. 
           [0058]      FIG. 26A  shows a side view of the folded folding glucose monitor as the door to the glucose testing strip holder is closed and the glucose test strip is inserted into the monitor. 
           [0059]      FIG. 26B  shows a side view of the folded folding glucose monitor with a glucose test strip in the glucose monitor as the lancing device pricks the user&#39;s finger in order to draw blood. 
           [0060]      FIG. 27  shows a side view of the folded folding glucose monitor as the user puts a sample of blood up to the testing strip in order to obtain a blood glucose. 
           [0061]      FIG. 28  shows a side view of the base device with the constant glucose monitor attachment. 
           [0062]      FIG. 29  shows a side view of the base device with the constant glucose monitor attachment being detached from the device for separate use. 
           [0063]      FIG. 30  shows a side view of the base device with the glucose tablet/candy attachment attached to the device. 
           [0064]      FIG. 31  shows a side view of the base device with the glucose tablet/candy attachment being detached, and a glucose tablet/candy being broken off for ingestion by the user. 
       
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
       [0065]      FIGS. 1A through 1E  show the various parts of the invention. A replacement pen cap disposal container and unused pen needle storage  32  comprises a replacement medication delivery pen cap section  9  that is attached to a sharps containment section  34  (with an angled lid assembly  33  and sharps disposal area  15 ), and an unused needle containment section  35  (with a hinged door  4  and unused needle storage area  3 ). Unused pen needles  1  shown with a foil covering on the larger posterior end  36  are held within the unused needle containment area  35  with the foil side  36  of unused pen needles  1  flush against the wall  21  that runs along the medication delivery pen  18 , with the bottom needle&#39;s foil side  36  flush against the medication delivery pen itself  18  due to the opening  2 . The unused needle containment section  35  is made of a solid piece of plastic above  17  and to the sides parallel  22  and a wall behind  21  the foil end of unused pen needles  36 , with the curved hinged opening door  4  that has a triangular opening in the center  7  containing teeth  23  and a bottom forming the final two walls (front and back). 
         [0066]    The unused needle storage area  3  is shown in  FIGS. 1A through 1C  as being only slightly larger in depth than the foil side diameters  36  of the unused insulin pen needles  1 . The hinged door  4  has a living hinge  10  at the top of the unused pen needle storage area  3 , with an opening that is a rounded triangular shape  7 . The unused pen needles&#39;  1  non-foil  38  end that comes to a point sticks through this opening  7  with the foil side  36  flush against either the wall  21  running along the medication delivery pen  18  or flush against the medication delivery pen  18  itself at the opening  2 . The largest part of the triangle  24  is the same size as the foil side  36  diameters of the unused pen needles  1  and circular in shape, with stiff flexible teeth  23  to hold the pen needle  1  inside until the user wishes to remove a pen needle as shown in  FIG. 10 . The door has tabs  5  in order to assist in pulling the door free from the latch  25 , as shown in  FIG. 8 . There is also two tabs  6  on the bottom of the hinged door  4  that can also be used for leverage to open the door, or as a stand to hold the device and pen upright when the pen is in place, forming a tripod with the bottom of the medication delivery pen  26  (see  FIG. 12 ). 
         [0067]    There is an opening  2  on the medication delivery pen  18  side of the unused pen needle storage section  35  where wall  21  ends, shown to the bottom left in  FIG. 1   b.  This opening is a square with sides just slightly larger than an unused pen needle&#39;s foil side  36  diameter, allowing a needle to be dispersed when the medication delivery pen  18  is removed, as shown in  FIGS. 5 and 6 . The medication delivery pen  18  slides into the pen cap  9  that the invention is attached to, and clips-in at the opening  8 . This pen cap is much like the medication delivery pen&#39;s own cap, being circular in nature but attaches to the slightly wider sharps containment section  34  and unused pen needle storage section  35  as the sides flair out  31 . 
         [0068]    As shown in  FIGS. 12 through 14 , the disposal method into the sharps containment section  34  involves a thumb opening the lid using the tabs  12 , placing a needle in the pre-containment area  27  on top of the plastic flexible teeth  13 , and using the hinged lid  11  to press the used pen needle  20  into the sharps disposal area  15 . The living hinge  14  to the lid is located at the bottom of the lid and attached to the lower portion of the sharps containment section  34 . The sharps disposal area  15  has four walls  28  and a bottom  17 . The four walls  28  and bottom  17  are watertight. The sharps container section comprises the sharps disposal area  15 , and the lid assembly  33 . The lid assembly  33  comprises the flexible plastic teeth  13 , the living hinge  14 , the lid itself  11 , and the very top part of the pen cap section  9 . The lid also features a groove for the user&#39;s thumb  29  (see  FIG. 13 ) that prevents the user&#39;s thumb from slipping off and helps more completely push medical waste out of the pre-containment area  27 , through the flexible plastic teeth  13 , and into the sharps disposal area  15 . The lid  11  snaps into place due to a groove in the pre-containment area  16  accompanied with a bump on the lid  30 . This lid assembly  33  is produced in one mold cavity in production so that the flexible plastic teeth  13  are made from a softer plastic then the rest of the device, which is to be made in a second cavity of the mold from harder plastic for the safety of the user. 
         [0069]    The first method for dispensing the unused pen needles is shown in  FIG. 2 through 6 .  FIG. 2  shows the medication delivery pen  18  labeled “insulin pen” being removed from the replacement pen cap  9 , and being pulled out the opening  8  as the device is rotated so it is inverted.  FIG. 3  then shows the unused insulin pen needle  1  being inserted into the unused pen needle storage section  35  of the inverted device through the opening  2  in the lower back portion of the device. The needles fall down to the bottom of the unused pen needle storage section  35  due to gravity, as their backs fall against the rear wall  21 . The thumb holds the device steady, resting on the bottom tabs  6 .  FIG. 4  shows the unused pen needles  1  completely filling the unused pen needle storage area  3 , with the smaller non-foil end  38  sticking out through the opening  7  in the hinged door  4 . The medication delivery pen system  18  is then shown being replaced into the opening  8  of the device&#39;s replacement cap section  9 . The entire device is then rotated back upright as the medication delivery pen  18  blocks the unused needle from falling out through the opening in the back  2 , while the teeth  23  in the opening  7  in the hinged door  4  keep the needle from falling out the opposite opening  24 .  FIG. 5  shows the medication delivery pen  18  being removed again from the pen cap  9 .  FIG. 6  shows that the invention is then rotated so that an unused pen needle  1  falls out the opening  2  now exposed by the missing medication delivery pen  18 , and into the user&#39;s hand. The remaining unused needles  1  then fall into space left by the dispensed needle, sliding along the opening  7  in the hinged door  4  and once again held in place by the teeth  23  once it reaches the bottom of the hinged door  4 . 
         [0070]    The second method for dispensing needles is shown in  FIGS. 7 through 11 .  FIG. 7  shows the medication delivery pen device  18  staying attached to the pen cap  9 . The entire assembly of the replacement cap pen needle dispenser and disposal  32  with the medication delivery pen  18  is then inverted.  FIG. 8  shows the user&#39;s thumb opening the hinged lid  4  from point where the lid snaps on  25  to the walls  22  of the containment area  3 . This is facilitated due to the living hinge  10  and the tabs  5 ,  6 . The unused needles  1  are loaded into the unused needle storage area  3  so that their foil covered side  36  is flush with the rear wall  21  to the containment area  3  and the non-foil side  38  sticks through the opening  7  in the hinged door  4  as the door is closed by the thumb in  FIG. 9 . The door snaps shut at  25 , and the needles are contained within the unused needle containment section  35 . The entire replacement cap pen needle dispenser and disposal  32  with the inserted medication delivery pen  18  is then flipped right side up once again.  FIG. 10  then displays the user grabbing an unused pen needle  1  by its non-foil end  38 , pulling it through the circular bottom  24  to the triangular opening  7 , and pulling the foil end  36  through the teeth  23  as they flex slightly.  FIG. 11  then displays the remaining unused needles  1  falling into place in the unused needle containment area  3  after one unused pen needle  1  has been removed. The remaining unused pen needles  1  slide along the opening  7 , with the bottom unused needle resting in the circular opening  24  with teeth  23 , waiting to be pulled out dispensed again when needed. 
         [0071]      FIGS. 12 through 14  display the disposal method for used medication delivery pen needle sharps  20 .  FIG. 12  shows a hand holding the sharps containment section  34  with the thumb using the tabs  12  located on either side of the lid  11  to open the hinged lid, allowing the used pen needle  20  to be placed inside ( FIG. 13 ) the pre-containment area  27  with the non-foil side  38  placed into the angled lid assembly  33  closest to the hinge of the angled lid  14  so that the used needle  20  is at a downward angle with the uncovered foil side  39  closest to the pen cap section  9 . The angled lid assembly  33  allows for the flexible plastic teeth  13  to be longer than the used pen needle  20 , even though the sharps disposal area  15  is only just slightly wider than the length of the used pen needle  20 , and only slightly larger in depth than the diameter of the foil side of the used pen needle  39 . It also allows for the thumb of the user to be protected from sharps due to both the lid  11  and the hinge  14  blocking any needle from protruding.  FIG. 13  then shows the used pen needle on top of the flexible plastic teeth  13 , below the lid  11 , in the pre-containment area  27 , ready for the groove on the lid  29  in which the user&#39;s thumb sits in to push the used pen needle  20  through the flexible plastic teeth  13 , and into the sharps disposal area  15  non-foil end first  38 .  FIG. 13  shows the thumb executing this closing motion to the lid  11 , pushing the used pen needle  20  into the sharps disposal area  15 , and in  FIG. 14  the used pen needle  20  falls preferentially horizontally into the sharps disposal area  15 , much as it once sat in the unused needle containment section  35 . 
         [0072]      FIG. 15  displays the full disposal container and unused pen needle storage  32  with the user&#39;s fingers ergonomically wrapping around the pen cap section  9 , and the thumb resting in the groove  29  on the lid  11  of angled lid assembly  33 . The sharps containment section is shown full at  34  with used needles  20  stacked both two horizontally  40  and two vertically  41 . This is meant to display that due to the length of used pen needles  20  being twice their diameter, the amount of space it takes to stack two horizontally  40  is the same space it takes to stack two vertically  41  within the containment area.  FIG. 15  also shows the unused needle containment section  35  full of unused needles  1  and the tabs  6  on the hinged door  4  forming a tripod with the bottom of the medication delivery pen  18 . Note that the base device (disposal container and unused pen needle storage replacement cap)  32  adds surface area to the device as it sits in the user&#39;s pocket, decreasing the chance that the whole base device  32  would slip out of one&#39;s pocket, but minimizing the amount of space the medication delivery pen  18  sticks out of the pocket when carried due to the device having relatively the same depth as the pen is in diameter. 
         [0073]      FIGS. 16 and 17  show the folding glucose monitor  58  that attaches to the disposal container and unused pen needle storage replacement cap&#39;s attachment point  45  with the glucose monitor&#39;s attachment point  62 . The glucose monitor  46  that makes up the upper half of the folding glucose monitor features a key chain hole  43 , the glucose monitor&#39;s attachment point  62 , buttons to scroll on the glucose monitor  42 , an insertion point for glucose testing strips  44 , and a screen to view blood sugar testing results  41 . The folding glucose monitor  58  folds on its hinge  47  that can be locked straight or folded. The lower half  57  of the folding glucose monitor  58  features a glucose testing strip holding container  49  with a door  48  that opens and covers the top of the container when the attachment is folded. The lancing device  56  that is the lower portion of the lower half  57  is made up of tabs  51  to pull back in order load the lancet so it can be fired through a hole  55  at the user&#39;s finger when the button  52  is pressed. It also features legs  54  to stand the device on, and a telescoping end  53  to adjust the depth that the lancet pierces the skin. 
         [0074]      FIGS. 18-22  show the folding glucose monitor  58  being used while attached to the disposal container and unused needle storage replacement cap  32 . The glucose monitor&#39;s attachment point  62  attaches to the disposal container and unused needle storage replacement cap&#39;s attachment point  45 . The door  48  to the glucose testing strip holder  49  is shown being opened in  FIG. 18 .  FIG. 19  shows a glucose test strip  60  being pulled from the bay  59  of the glucose testing strip holder  49 .  FIG. 20  shows the glucose test strip  60  being inserted into the glucose monitor  46  through the test strip insertion point  44  at the top of the glucose monitor  46 . The door  48  to the glucose testing strip holder  49  is also shown being shut in  FIG. 20 .  FIG. 21  shows the lancing device  56  being loaded and readied via tabs  51 . The button  52  on the lancing device  56  is then shown being pressed thus firing the lancet at the user&#39;s finger through a hole  55 . In order to adjust depth, the user can use the telescoping end  53  to the lancing device  56 . The legs  54  on the folding glucose monitor  58  also serve to hold the user&#39;s finger in place as the lancing device  56  pricks their finger.  FIG. 22  shows the user bringing the sample of blood  61  on their finger to the glucose test strip  60 . The blood is drawn into the glucose test strip  60  and the glucose monitor  46  then reads the results through electrical connections to the glucose test strip  60  in the test strip insertion point  44  that the glucose test strip  60  is inserted into. The glucose monitor  46  then displays the results on the screen  41 . The user can then scroll through the results using the buttons  42  on the device. It is important to note that the folding glucose monitor device  58  can be used in this same way when it left locked and straight and is detached from the disposal container and unused needle storage device  32 . 
         [0075]      FIGS. 23-27  show the folding glucose monitor  58  being removed as an attachment, folded, and used separately.  FIG. 23  shows the glucose monitor&#39;s attachment point  62  being detached from the disposal container and unused needle storage device&#39;s attachment point  45  as the folding glucose monitor device  58  is pulled off the disposal container and unused needle storage device  32 .  FIG. 24  shows the folding glucose monitor  58  being folded at the hinge  49  so that the top half (the glucose monitor)  46  folds to match up with the bottom half  57 . The folding glucose monitor  58  will fold so bottom half attachment point  50  would match up with the glucose monitor attachment point  62  and snap in.  FIGS. 25A and 25B  then show getting a test strip  60  out of the folded folding glucose monitor  58 .  FIG. 25A  shows the door  48  to the glucose testing strip holder  49  being opened. The door  48  covers the roof to the glucose testing strip holder  49 , so when it is opened the testing strips  60  are left completely exposed. This is shown in  FIG. 25B  as a user pulls a testing strip  60  out of the bay  59  of the glucose testing strip holding area  49 . In  FIG. 26A  the glucose test strip  60  is inserted into the glucose monitor  46  via the test strip insertion point  44  as the door  48  to the glucose testing strip holder  49  is shut.  FIG. 26B  shows the user loading the lancing device  56  by pulling back the tabs  51  and pricking his finger by pressing the button  52  to release the lancet. The glucose monitor  46  and the legs  54  hold the users finger in place. The user can adjust the depth of the prick with the telescoping end  53 .  FIG. 27  shows the user bringing his blood sample  61  to the glucose test strip  60  that is in the glucose monitor  46 . The glucose monitor  46  reads the sample and displays the results on the screen  41  which the user can scroll through with the buttons  42 . 
         [0076]    This folding and locking mechanism is a unique characteristic of the folding glucose monitor  58  and the invention as a whole, since currently no other glucose monitors fold in such a way. As well, the device, once folded, would be flat and so much easier to carry and hold than existing glucose monitor testing systems. Another unique characteristic is that it has a key chain hole and so it can be used as a key fob, increasing the chances that it will be carried, and pairing the device with the user&#39;s keys to reduce the number of devices the user needs to carry. This means keys can also be attached to the overall invention when the glucose monitor is attached. 
         [0077]      FIGS. 28 and 29  show a constant glucose monitor  65  being detached from the disposal container and unused needle holder replacement cap  32 .  FIG. 28  shows the constant glucose monitor  65  being taken off by its attachment point  68  off of the disposal container/unused needle holder&#39;s attachment point  45 . The constant glucose monitor  65  features a screen  66  to display the information it receives wirelessly from a probe and buttons  67  to navigate the results.  FIG. 29  shows the constant glucose monitor  65  taken off the disposal container/unused needle storage replacement cap  32  for use on its own or to be paired with the glucose tablets/candy attachment  73 . This offers the user the most flexibility in its use and with that have the greatest convenience to the user. 
         [0078]      FIGS. 30 and 31  shows the glucose tablets/candy attachment  73  being taken off and a glucose tablet/candy  71  being broken off to be ingested.  FIG. 30  shows the glucose tablet/candy attachment  73  attached via its primary attachment point  70  to the replacement cap disposal container and unused test strip holder&#39;s attachment point  45 . It is imperative to note that glucose tablet/candy attachment  73  also features a secondary attachment point  72  so the folding glucose monitor  58  or the constant glucose monitor  65  can be attached to the glucose tablets/candy attachment  73  by each of their own attachment points ( 62  and  68 , respectively). This means that the glucose tablets can be carried alone, with one of the glucose monitors ( 58  or  65 ), with just the disposal container/unused needle holder disposable cap  32 , or with all three devices at once. This gives the diabetic the most options and control over all three essential pieces to diabetic life.  FIG. 31  shows the glucose tablets/candy attachment  73  being taken off the disposal container/unused needle holder&#39;s attachment point  45 . A glucose tablet/candy  71  is broken off to raise a diabetic&#39;s blood sugar. Glucose/carbohydrates are the most critical part of diabetic&#39;s life since they pose the greatest immediate risk to their survival. Without something to raise blood glucose, a diabetic can go into shock or seizures within minutes. This is why the glucose tablets/candy attachment  73  serves to be the piece that has the most diverse carry options: so there is never a reason to leave it behind. This is why it features both the primary attachment point  70  and the secondary attachment point  72 . The glucose/candy  71  will also be flat and compact so that it can easily fit between the two devices and take up as little room as possible, increasing the chances it will be carried. 
         [0079]    In summary, the invention contemplates a disposable cap that replaces a cap to a medication delivery pen with either or both a sharps container attached to the side, and a gravity fed pen needle dispenser below the sharps container. This allows the patient to easily carry a medication delivery pen, its needles, and have a method to store contaminated sharps. Attached to this base device are supplementary devices that can be added or removed at the discretion of the user. These supplementary devices could also be attached to their own replacement pen cap for the medication delivery pen to be used individually with the medication delivery pen. They can also be stacked together or removed at the user&#39;s discretion. These attachments are a folding glucose monitor complete with a lancing device and a glucose testing strip holder, a constant glucose monitor, and glucose tablets/candy. All devices needed to check a diabetic&#39;s glucose, correct the blood glucose (with either ingestion of carbohydrates/glucose or an injection of insulin via the medication delivery pen), and dispose of all materials in the process is in one device. It also gives the user the most options and flexibility to fit any one or all of the devices into their lives as they please. 
         [0080]    The sharps containment section includes an angled lid assembly that serves a number of purposes. First, the lid assembly&#39;s angled nature is ergonomic and natural in the way it fits in the user&#39;s hand. The angle of the lid assembly also causes the used pen needles to be pushed through non-foil side first so that they preferentially stack horizontally within the containment area, which leads to more efficient storage as a result. The angle of the lid assembly serves to increase the length of the area of flexible teeth so that used medication delivery pen needles pass through more easily. 
         [0081]    The sharps container has a groove in the lid that both more completely pushes material out of the pre-containment area and into the containment area, but also prevents the user&#39;s thumb from slipping off the lid assembly. Finally, the lid and hinge run along the length of the user&#39;s thumb as to provide the most amount of protection to the user&#39;s thumb. 
         [0082]    The sharps containment area, which is slightly wider as a medication delivery pen needle is long and in depth is slightly larger than the diameter of a medication delivery pen needle. This design allows for pen needles to stack in the most efficient way, forcing the first two (or all) medication delivery pen needles to fall horizontally or vertically, both taking up the same amount of space within the containment area so as to maximize storage potential. Horizontal stacking is preferable because it minimizes the chances of other needles being caught on each other and the lid assembly helps in ensuring this occurs, but is not perfect in its function at doing so. 
         [0083]    The gravity fed pen needle dispenser is attached to the medication delivery pen via a replacement cap that has a loading and dispensing method that comprises a square opening slightly larger than the diameter of unused medication delivery pen needles that the medication delivery pen needles are fed into when the medication delivery pen is removed. When the medication delivery pen is replaced by being inserted into the cap the pen needles cannot fall out. Once the medication delivery pen is removed once again, the unused pen needle falls out of the opening for use by the patient. The remaining needles fall into place ready to be dispensed due to gravity. 
         [0084]    Another method of dispensing uses a loading method wherein the assembly is inverted, a hinged door is opened on the side opposite the square opening, the pen needles are placed horizontally within it, and the hinged door is closed with the pen needles sticking through that opening. The hinged door has a rounded triangular opening with teeth and the very lowest part being just bigger than the largest diameter of the unused pen needle due to the teeth protruding from the opening. This holds in the medication delivery pen needles until the user wishes, and when the user wishes the unused medication delivery pen needle could be pulled through this opening thanks to the flexing of the teeth in the opening. Remaining unused needles fall into this bottom part of the triangular opening due to gravity and are ready to be dispensed and used. 
         [0085]    The folding glucose monitor attachment is designed with features to make it as compact and user friendly as possible. The glucose testing strip holder is in the center so it can be easily accessed when straight or folded and there is free access for the user&#39;s finger to the lancing device and glucose test strip when it is inserted into the monitor. A second feature is that the monitor is the same depth width and length as the lower half that comprises the lancing device and test strip holder. This makes the device able to be folded in half so that it is the same depth and flat, as the two halves match together. The folding mechanism is then also an important feature of this device since it lets the user choose between a long, pen style glucose monitor or a flat wider glucose monitor when detached. The folding mechanism also makes use of the same attachment point that it uses to attach to the disposal container and unused needle storage device to attach to itself. The placement of the monitor, glucose test strips, and lancing device is then ideal for both when the device is straight and when it is folded, so their placement is an important feature. 
         [0086]    A glucose monitor, whether the constant glucose monitor or folding glucose monitor, attached to the medication delivery pen via a replacement cap allows for less devices to be carried by the diabetic in a more efficient manner. This is an important distinction to be made between this invention and existing devices or ideas, and this is true for the glucose monitor, the glucose tablets, the unused pen needle storage, and the disposal container. The idea of attaching devices the diabetic needs to the medication delivery pen via a replacement pen cap is a new idea and the focus of this invention. 
         [0087]    Finally, the ability of the glucose tablets/candy attachment to have a second identical attachment point onto which the glucose monitor of the user&#39;s choice can attach to is another important feature. This allows all devices to fit together in the most space friendly and easy to use fashion. It also allows the user to carry the glucose tablets/candy with either the glucose monitor or the disposal container and unused needle storage cap at the discretion of the user. This is important because above all a diabetic needs to always have some form of glucose/carbohydrate with them since hypoglycemia (low blood sugar) poses the greatest immediate threat to a diabetic&#39;s life. 
         [0088]    The principle and mode of operation of this invention have been explained and illustrated in its preferred embodiment. However, it must be understood that this invention may be practiced otherwise than as specifically explained and illustrated without departing from its spirit or scope.

Technology Category: 1