Patent Abstract:
A medical device pump with a housing with a compartment for removably receiving a cartridge containing a therapeutic agent, a conduit configured to operatively provide a fluid flow path for therapeutic agent to exit from the cartridge, a user activated delivery button, a trigger mechanism, and a mechanical pump mechanism. The trigger mechanism, user activated delivery button and mechanical pump mechanism of the medical device pump are configured such that the trigger mechanism is activated by a user fully activating the user activated delivery button. Moreover, such full activation generates mechanical power employed by, and sufficient for, the mechanical pump mechanism to pump a predetermined volume of therapeutic agent from the cartridge and through the fluid flow path.

Full Description:
FIELD OF THE INVENTION 
       [0001]    The present invention relates to medical devices, and, more particularly, to medical device mechanical pumps for delivering therapeutic agents. Embodiments of the present device are useful for medical drug delivery devices, including small, low cost insulin delivery devices worn on the skin for treating Type 1 and Type 2 diabetes. 
       BACKGROUND OF THE INVENTION 
       [0002]    Transcutaneous delivery of medicine is an alternative to orally delivered pharmaceuticals, which reach the blood stream by way of the intestines. Some medicines lose their effectiveness when ingested and must be delivered using other means. Parenteral delivery refers to delivery of medicine to the body by means other than via the intestines. Intradermal, subcutaneous, and intravenous injections are examples of parenteral delivery. 
         [0003]    Insulin is an example of a medication that must be administered using parenteral delivery. Insulin is injected by patients with Type 1 diabetes, and some patients with Type 2 diabetes. In Type 1, or juvenile onset diabetes, the pancreas no longer produces insulin, and insulin must be injected to regulate blood sugar. In Type 2 diabetes, the body loses its sensitivity to insulin, and more insulin is required to regulate blood sugar. In the later stages of the disease, the pancreas of a Type 2 diabetic stops producing insulin, and the patient becomes insulin dependent, similar to a Type 1 diabetic. 
         [0004]    Different patients adopt different insulin regimens, depending on many factors, including the type and stage of the disease, access to medical care, support by family members, lifestyle, motivation, and attitude toward the disease. A healthy pancreas secretes insulin at a low, steady basal or background rate, and produces larger boluses of insulin in response to food intake. Injections of long acting insulin (formulated to be taken up by the body slowly and steadily over a period of several hours) are used to mimic basal insulin, and injections of rapid acting insulin (formulated to be taken up quickly) are used for boluses. Type 1 diabetics and insulin dependent Type 2 diabetics typically adopt regimens that include both basal and bolus insulin. Type 2 diabetics new to insulin might start on a relatively low dosage of basal insulin only, with one shot a day of long acting insulin. Alternatively, new to insulin Type 2 diabetics might start on a relatively low dosage of bolus only insulin, taken one to two times a day with meals. With time, Type 2 diabetics will increase their insulin dosage and add bolus or basal insulin to complement their initial insulin regimen. 
         [0005]    Typically, the insulin is drawn up from a vial and injected with a syringe and needle. Insulin therapy with syringes and vials is low in cost but requires significant skill and dexterity to draw up the proper amount of insulin and purge bubbles. Insulin pens are popular in Europe and are beginning to displace syringes in the United States. Insulin pens are comprised of a prefilled insulin cartridge with a plunger, a needle, a mechanism that allows the user to dial in the specific amount of insulin to be delivered, and a button to inject the insulin. Such pens are, in essence, hand-held medical fluid delivery devices. Disposable insulin pens with an integrated insulin cartridge and reusable insulin pens with replaceable insulin cartridges are both available on the market today. Insulin pens are convenient and easy to use, eliminating the need to draw up the insulin into a syringe, allowing the patient to set the dose by turning a dial rather than trying to read a meniscus in a small, finely graduated syringe, and simplifying the elimination of bubbles, which affect delivery accuracy. 
         [0006]    Continuous subcutaneous insulin infusion (CSII), or insulin pump therapy, is a preferred method for delivering insulin to diabetic patients, and is known to have certain advantages over injection of insulin with syringes or pens. Insulin pump therapy consists of a low, steady basal delivery, with larger bolus deliveries taken in conjunction with food intake, a pattern that closely resembles insulin secretion from a healthy pancreas. Instead of using long acting insulin for basal delivery, insulin pumps deliver small shots of rapid acting insulin at regular time intervals to approximate slow continuous delivery. Recently introduced “smart pumps” have features that keep track of insulin injection history, remember commonly used dosages, help calculate bolus size, and allow for fine-tuning of basal and bolus delivery. Insulin pumps also offer increased lifestyle flexibility through frequent, convenient insulin dosing, allowing the user to eat what they want when they want and still maintain control of their blood glucose levels. 
         [0007]    Insulin pumps are comprised of the pump engine, an insulin reservoir, and an infusion set which delivers insulin from the pump across the skin to the patient. The infusion set may be worn for multiple days, allowing infusion of insulin across the skin as required without the need to pierce the skin multiple times with needles for individual injections. The pump may be worn on a belt clip, or placed in a pants pocket, holster, or bra, for example. The pump is connected to the user via an infusion set, comprised of a transcutaneously inserted cannula affixed to the body with an adhesive patch, with a length of plastic tubing linking the cannula to the pump. The cannula is usually attached to the user&#39;s abdomen region, although other locations such as the lower back or thigh may be used. A new generation of pumps known as patch pumps is now beginning to appear on the market. These pumps are smaller in size and affix directly to the skin such that the tubing leading to the cannula is shortened or eliminated entirely. 
         [0008]    There are several problems associated with existing approaches to insulin delivery, and insulin therapy in general. Even though insulin therapy is known to be the best way to limit glycemic excursions, Type 2 patients resist starting insulin. Many patients associate insulin with the last stages of the disease leading to death, they are afraid of needles and giving themselves injections, and the therapy is complicated and confusing, involving carbohydrate counting, regulation of food intake, and the relationship between insulin, food, and exercise. Physicians delay putting their Type 2 patients on insulin because the patients are resistant, it is difficult and time-consuming to initiate and manage patients on insulin therapy, and they are afraid of dangerous and potentially fatal hypoglycemic events induced by delivering too much insulin. This delay in starting insulin therapy accelerates the course of the disease. 
         [0009]    As mentioned above, the needles used with syringe and pen injections are intimidating to patients. Some patients have needle-phobia and just the thought of injecting causes anxiety. For both syringes and pens, the patient must remember to carry the insulin and supplies with them if they are going to inject away from home. Syringes require the user to draw up the insulin from a vial and purge bubbles, a multi-step process requiring significant skill, dexterity, and visual acuity to perform accurately. In addition, syringes offer no means for creating a time record of delivery, other than relying on the patient to keep a logbook. 
         [0010]    Insulin pens solve many of the problems associated with syringes, greatly simplifying the injection process. However, they still require the use of needles, and can be inaccurate if the patient does not prime the pen before injecting or does not keep the needle in the skin and hold the button down for a sufficient length of time during the injection. Recently introduced smart pens keep a primitive record of the most recent injections, but cannot distinguish priming shots from regular injections, and do not allow for downloading and analysis of the insulin data in conjunction with blood glucose data. 
         [0011]    While insulin pumps offer many benefits relative to syringes and pens, they also have several problems. Insulin pumps are expensive, complex devices with many features, requiring multiple steps to set up and use. Thus they are difficult for health care providers to learn and teach, and for patients to learn and use. Conventional insulin pumps use indirect pumping in which a motor and gears drive a lead screw, which pushes on a plunger in a syringe-like cartridge to inject the insulin. The indirect pumping approach is susceptible to over-delivery of insulin due to siphoning and pressure differentials. 
         [0012]    Bubbles present a major challenge with conventional insulin pumps, which rely on the user to fill a syringe-like reservoir. It is difficult for the user to purge all of the air out of the system when setting up the pump, and additional bubbles can form when dissolved gas in the insulin comes out of solution due to changes in temperature or pressure. During delivery, bubbles displace insulin and reduce delivery accuracy. For example, a small 10 microliter bubble passing through the pump to the user is equivalent to 1 unit of missed insulin. Pre-filled insulin cartridges come to the user with approximately 20-40 microliters of air in the cartridge, and more gas can come out of solution during use. 
         [0013]    Endocrinologists prescribe most insulin pumps, but many diabetics only see primary care physicians (PCPs). Many physicians, including endocrinologists and PCPs, are unwilling to put their patients on pumps because they don&#39;t think their patients can handle it, or because it will cause more work for the physicians that they are not reimbursed for. The pumps are relatively large, making them difficult to wear and operate discretely. Insulin pump therapy is expensive, with conventional pumps costing approximately $5,000 up front. A low cost pump could make insulin pump therapy more accessible, but it is important to provide the accuracy and critical safety benefits of conventional pumps such as occlusion detection and delivery confirmation. Furthermore, it would be beneficial to maintain a delivery record for retrospective analysis by the physician and/or patient. 
         [0014]    For these reasons, currently available insulin pumps are used predominantly by a small class of insulin-using diabetics—sophisticated Type 1 patients who meticulously monitor their blood glucose levels and are proficient at counting carbohydrates to determine insulin dosing. Many people who could benefit from insulin pump therapy, such as Type 2 diabetics, are unable to use them or choose not to use them because of the disadvantages discussed above. 
         [0015]    Thus, it is desirable to have an insulin pump that is low in cost, accurate, safe, and simple enough to teach and use that primary care physicians (PCPs) would put their insulin using Type 1 and Type 2 patients on the pump, allowing more diabetics to benefit from the advantages of insulin pump therapy. The device would have the simplicity and low cost of an insulin pen, combined with the convenience, lifestyle benefits, data logging, and safety features of a pump. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0016]      FIG. 1  is a simplified perspective view depiction of a medical device mechanical pump according to an embodiment of the present invention, an infusion set patch, and a pre-filled cartridge; 
           [0017]      FIG. 2  is a simplified perspective view depiction of the medical device mechanical pump of  FIG. 1  with the pre-filled cartridge inserted and attached to the infusion set patch; 
           [0018]      FIG. 3  is a simplified perspective view depiction the medical device mechanical pump of  FIG. 1  with the upper housing removed, revealing the inner components of the medical device mechanical pump; 
           [0019]      FIG. 4  is a simplified cross section of a mechanical pump engine (also referred to herein as a “micropump”) with integrated bubble trap that draws fluid from the pre-filled cartridge and can be employed in various embodiments of the present invention. 
           [0020]      FIG. 5  is a simplified exploded perspective view of a micropump actuation triggering mechanism as can be employed in various embodiments of the present invention; 
           [0021]      FIG. 6  is a simplified exploded perspective view of a micropump actuation triggering mechanism as can be employed in various embodiments of the present invention; 
           [0022]      FIG. 7  is a simplified exploded perspective view of the micropump actuation triggering mechanism of  FIG. 6  from another viewpoint; and 
           [0023]      FIG. 8  is a simplified depiction of a passive circuit to enable one-way communication from a medical device insulin pump according to an embodiment of the present invention and an associated blood glucose meter. 
           [0024]      FIGS. 9A-9B  are simplified cross sectional views of a mechanical pump engine with integrated delivery counter as can be employed in various embodiments of the present invention. 
           [0025]      FIG. 10  is a perspective view of a reset mechanism that can be used with the mechanical pump engine with integrated delivery counter illustrated in  FIGS. 9A-9B . 
       
    
    
     DETAILED DESCRIPTION 
       [0026]    The present invention relates to medical device mechanical pumps, and, more particularly, to medical device mechanical pumps (also referred to herein as a “mechanical pump” and/or a “medical device pump”) for delivering therapeutic agents. Although a simple mechanical patch pump for delivering insulin or other therapeutic agents is described for the purpose of example, one of skill in the art would understand that other embodiments of this device could be used for other devices that would benefit from a mechanical pump, such as hand-held insulin pens (a type of portable user-operated medical fluid delivery device), more complex insulin pumps with additional features, belt or pocket worn insulin pumps, and medical fluid delivery devices for delivering other therapeutic agents such as drugs or other fluids for other applications such as for treating pain. 
         [0027]    One aspect of the present invention is to provide an easy to teach, easy to learn, easy to use mechanical pump for delivering insulin. The simple mechanical pump does not require electronics or battery power for delivering insulin, instead relying on power provided by the user when pressing the delivery button. Another aspect of the present invention is to provide a pump that delivers discrete shots of a fixed size with each button press that can be used to deliver long acting basal insulin, regular or rapid acting insulin for boluses, or a mix of long acting and regular or rapid acting insulin for basal/bolus therapy. Another aspect of the present invention is to provide a low cost insulin patch pump comprised of a disposable patch pump that accepts pre-filled cartridges and attaches to a disposable infusion set. Another aspect of the present invention is to provide a low cost mechanical pump that provides beneficial safety features and accuracy. Another aspect of the present invention is to provide a simple, low cost means of communication from the disposable pump to a blood glucose meter to confirm and record insulin delivery events. Another aspect of the present invention is to provide a simple, low cost means of counting pump deliveries. 
         [0028]    The mechanical pump disclosed herein is useful for delivering insulin to diabetic patients, and also may be used for delivering other drugs, cells, genetic material such as DNA, and biopharmaceuticals including protein-based drugs, for applications such as treatment for diabetes, Parkinson&#39;s disease, epilepsy, pain, immune system diseases, inflammatory diseases, and obesity (referred to generally as therapeutic agents). 
         [0029]    The mechanical pump, generally denoted by  100  in  FIG. 1 , accepts pre-filled insulin cartridge  170  and docks onto adhesive patch platform  210 . Using a pre-filled insulin cartridge greatly simplifies the pump set up for the patient, eliminating the need to draw up insulin from a vial and purge bubbles. In a preferred embodiment of the present invention, mechanical pump  100  is affixed directly to the skin via adhesive patch platform  210 . Mechanical pump  100  is simple in nature and has minimal features evident from the outside. These include insulin cartridge compartment  150 , cartridge door  130 , lower housing  190  and upper housing  140 , safety release button  120  and delivery button  110 . Upon inserting insulin cartridge  170  into insulin cartridge compartment  150  and closing cartridge door  130 , conduit  160  penetrates septum  180 , providing access to insulin inside cartridge  170 . Attached to adhesive patch platform  210  is flexible cannula inserter  200  with inserter lever  220  and flexible cannula  230 . 
         [0030]    Referring now to  FIG. 2 , mechanical pump  100  is shown attached to adhesive patch platform  210  with insulin cartridge  170  inserted into insulin cartridge compartment  150  and cartridge door  130  closed. Flexible cannula inserter lever  220  is in the down position, with flexible cannula  230  protruding from the bottom side of adhesive patch platform  210 . 
         [0031]      FIG. 3  shows mechanical pump  100  with upper housing  140  removed to reveal internal components, which are shown in detail in  FIG. 4 ,  FIG. 5 , and  FIG. 6 . Pressing safety release button  120  slides safety release rod  300  forward, allowing delivery button  110  to be pressed in. Pressing delivery button  110  activates trigger mechanism  310 , which in turn generates a single stroke from micropump  320 . Stroke from micropump  320  first generates a pressure drop that sucks in insulin from insulin cartridge  170  via conduit  160 , and through bubble trap  330 , then delivers insulin via delivery conduit  340  to flexible conduit  230  and across the skin to the patient. 
         [0032]    Focusing now on  FIG. 4 , a cross section of micropump  320  and bubble trap  330  is provided. Pressing down on flexible diaphragm  430  pressurizes pump chamber  420 , closing inlet valve  440 , which seals pump inlet  500 , opening outlet valve  460 , and delivering fluid through channel  450  to pump outlet  470 . The volume of fluid delivered to pump outlet  470  is equivalent to the volume of pump chamber  420  displaced by flexible diaphragm  430 . Allowing flexible diaphragm  430  to return to the up position as pictured in  FIG. 4  causes the pressure in pump chamber  420  to drop. The drop in pressure closes outlet valve  460 , sealing channel  450 , and lifts inlet valve  440 , opening pump inlet  500  and causing fluid to fill pump chamber  420  via pump inlet channel  560 . 
         [0033]    Before entering the pump, fluid passes through bubble trap  330 , which is comprised of bubble trap housing  570 , bubble trap inlet  580 , bubble trap chamber  590 , and porous membrane  530 . In a preferred embodiment, porous membrane  530  is hydrophilic and has an average pore size between approximately 0.05 and 2 microns. Hydrophobic porous material also will work for the bubble trap. Bubble trap  330  prevents bubbles originating in the insulin reservoir from reaching micropump  320 , where they could increase compliance of the system and affect delivery accuracy. Bubble trap  330  also filters particles out of the system before reaching micropump  320 , where they could prevent inlet valve  440  or outlet valve  460  from sealing properly. During priming, micropump  320  pumps air out of the system and fills conduit  160 , bubble trap chamber  590 , pump inlet channel  560 , pump chamber  420 , delivery conduit  340 , and flexible conduit  320  with fluid from cartridge  170 . The process of filling wets porous membrane  530 , and subsequent bubbles released from cartridge  170  become trapped in bubble trap chamber  590 . Bubble trap  330  is designed such that the volume of bubble trap chamber  590  is greater than the volume of bubbles that might exist within cartridge  170 . 
         [0034]    Continuing with  FIG. 4 , Pump chamber o-ring  480  seals upper pump housing  510  to valve seat plate  550 , lower housing o-ring  490  seals lower housing  520  to valve seat plate  550 , and bubble trap o-ring  540  seals bubble trap housing  570  to back side of valve seat plate  550 . Upper pump housing  510 , valve seat plate  550 , lower housing  520 , and bubble trap housing  570  are attached to each other using screws, adhesive, pins on one side that interfere with holes on the other, heat staking, or ultrasonic welding. 
         [0035]    Trigger mechanism  310 , shown in  FIG. 5  and  FIG. 6 , serves to translate presses of delivery button  110  into pumping cycles of micropump  320 . A function of trigger mechanism  310  is to ensure that partial presses of delivery button  110  cannot produce a fraction of a full pump stroke. When delivery button  110  is pushed past a specific distance, trigger mechanism  310  activates a complete pump stroke. When delivery button  110  is pushed less than the specific distance, no pump stroke is produced. Similarly, the triggering mechanism ensures that the patient must fully release delivery button  110  before pressing again to deliver another pump stroke, a feature that likewise prevents activation of a partial pump stroke. 
         [0036]    In  FIG. 5 , trigger mechanism  310  is shown in relation to micropump  320 . Trigger mechanism housing  650  is shown removed to reveal trigger mechanism  310 . Piston  610  engages flexible diaphragm  430 . Activation rod  620  is attached to delivery button  110  and is biased in the out position by coil spring  640  which pushes against snap ring  630 .  FIG. 6  and  FIG. 7  show components of trigger mechanism  310  in more detail from two viewing angles. Piston  610  and leaf springs  720  are shown separated from the trigger mechanism assembly for clarity. In the rest position (delivery button  110  not pressed), trigger mechanism body flat  780  contacts piston flat  790 , maintaining piston  610  in the down position such that micropump diaphragm  430  is biased downwards, such that it presses down on and actively closes inlet valve  440 , providing an extra measure of safety against over-delivery of insulin. Pressing delivery button  110  pushes activation rod  620 , compressing coil spring  640  and pushing trigger mechanism body  730  forward. First pin  710  protrudes outwardly from trigger mechanism body  730  and rides along piston ledge  650 , preventing piston from rising. First pin  710  is biased inwards by one of leaf springs  720 . When first pin  710  is pushed beyond piston ledge  650 , piston  610  rises and first pin  710  slides into ramped piston slot  770 . When delivery button  110  is released, coil spring  640  pushes activation rod  620  back towards the rest position, and ramp  740  on trigger mechanism body  730  engages piston ramp  750 , pushing piston back down to the rest position, where it is held in place with trigger mechanism body flat  780  again contacting piston flat  790 . If the patient tries to re-press delivery button  110  before trigger mechanism has returned to the rest position, second pin  700 , biased inwards by one of leaf springs  720 , engages detent  760 , stopping motion of trigger mechanism body  730  and preventing delivery of a partial bolus. Under normal operating conditions when pressing delivery button  110 , second pin  700  slides over vertical piston ramp  660 , allowing forward motion of trigger mechanism body  730 . 
         [0037]    Mechanical pump  100  includes a simple, low cost, batteryless means for one-way communication to a blood glucose meter. Communication from the pump to the meter is useful for recording and time stamping insulin delivery events for later review by the patient and/or health care provider. This information can be useful to the patient, for example, to remember whether or not they have already delivered their insulin. One embodiment for communicating from mechanical pump  100  to a blood glucose meter is shown in  FIGS. 8  A and B. Radio frequency identification (RFID) tag  810  is connected to antenna  800  with switch  820  included in the circuit, and blood glucose meter  840  has an antenna and other electronics required to read RFID tag  810 . When mechanical pump  100  is in the rest state (delivery button  110  not pressed), and blood glucose meter  840  is within range of mechanical pump  110 , blood glucose meter  840  detects the presence of RFID tag  810  due to wireless signal  850 , as shown in  FIG. 8A . At this time, blood glucose meter  840  can read information stored on RFID tag  810 , such as the amount of insulin delivered per press of delivery button  110 , the type of insulin, and manufacturing date and identification information for mechanical pump  100 . 
         [0038]    By reading identification information for mechanical pump  100  from RFID tag  810 , blood glucose meter  840  can keep track of how long the patient has used a particular pump, and alert or warn the user when it is time to change pumps to prevent mechanical pump  100  from being used beyond its intended lifetime. Now referring to  FIG. 8B , pressing delivery button  110  pushes activation rod  620  in the direction of the arrow, causing switch pin  830  to open switch  820 , and interrupting wireless signal  850 . Blood glucose meter  840  recognizes interruption in wireless signal  850  as an insulin delivery event, and records the event in its memory, along with a time stamp of the event. Blood glucose meter  840  also can display the insulin delivery event to the patient to confirm delivery and to guide the patient regarding how much insulin remains be delivered. The stored insulin delivery data also can be used to display to the patient how much insulin remains in cartridge  170 . The insulin delivery data can be displayed along with blood glucose and food intake data also stored on blood glucose meter  840  to help the patient manage their blood glucose levels. 
         [0039]    Alternatively, RFID  810 , antenna  800 , and switch  820  can be configured such that switch  820  is open when mechanical pump  100  is in the rest state. In this configuration, pressing delivery button  110  closes switch  820 , signaling to blood glucose meter  840  that an insulin delivery event has occurred. If it is desired to increase the range with which information can be sent from mechanical pump  100  to meter  840 , or increase the certainty by which the signal from mechanical pump  100  is received by meter  840 , a battery can be included in the circuit with antenna  800 , RFID tag  810 , and switch  820 , rather than relying entirely on power being supplied by meter  840  to read information from mechanical pump  100 . Alternatively, a piezoelectric or other energy-generating device can be incorporated in mechanical pump  100  such that pressing delivery button  110  generates power that is used to transmit signal  850  to blood glucose meter  840 . Instead of opening or closing a switch, the device could be configured such that pressing activation button  110  shields or unshields RFID tag  810 , making its signal alternately detectable or undetectable by blood glucose meter  840 . 
         [0040]    It may be desirable to improve the reliability of the one-way communication between mechanical pump  100  and blood glucose meter  840 . This can be accomplished by incorporating two or more RFID tags and associated antennas. For example, one RFID tag can be configured such that it can be read (i.e., detected) by meter  840  when delivery button  110  is not pressed, while a second RFID tag can be configured such that it cannot be read (i.e., detected) by meter  840  when delivery button  110  is not pressed. In such an embodiment, pressing delivery button  110  would make the first RFID tag undetectable and would make the second RFID detectable. Meter  840  would be configured to detect transitions in detectability from both tags in order to determine that a delivery event has occurred. By including additional RFID tags, a digital logic communication scheme can be easily implemented in which various tags are activated and deactivated to signal different use events. 
         [0041]    It may be desirable to transmit more detailed information about the delivery event from mechanical pump  100  to meter  840 , for example the sequential number associated with each delivery, or the delivery volume for the case where the bolus delivery volume is variable rather than fixed, for example for an insulin pen. In these cases, a more complex circuit can be included in mechanical pump  100 , and two-way communication between mechanical pump  100  and meter  840  can be implemented. 
         [0042]    In the present example, mechanical pump  100  communicates with blood glucose meter  840 . However, devices other than a blood glucose meter can be used to communicate with mechanical pump  100 , for example a telephone, continuous glucose monitor, remote controller, personal digital assistant, computer, or a network appliance. 
         [0043]    In another embodiment of the present invention, mechanical pump  100  can be configured as an external device, rather than attaching it to the body via an adhesive patch. Similar to an insulin pen, the delivery mechanism can be configured to allow the user to dial in the desired dose before injecting, rather than delivering a fixed shot size with each press of the delivery button, and the mechanism can push on the plunger of the insulin cartridge, rather than using micropump  320  to suck fluid out of the reservoir. For an external device, it is important to prime the system before each use. Priming complicates the storage of bolus data, since the device must distinguish between bolus delivery and priming events. One option to address this issue is to have the blood glucose meter instruct the patient when to prime, and to record the next delivery event as a priming event. Another approach is to include a sensor on the delivery device to sense contact with the skin during a delivery event. This can be accomplished with a switch that closes when the device is brought into contact with the skin. The switch would remain open during a priming event. The status of the switch (and thus the type of event, delivery to the body or prime) would be communicated from the pump to the blood glucose meter to store with the associated delivery event in the data log. 
         [0044]      FIGS. 9A-9B  are simplified cross sectional views of a mechanical pump engine with integrated delivery counter  900 , as can be employed in various embodiments of the present invention.  FIG. 10  is a perspective view of a reset mechanism that can be used with mechanical pump engine with integrated delivery counter  900 , as illustrated in  FIGS. 9A-9B . Mechanical pump engine with integrated delivery counter  900  includes delivery counter  902 . Delivery counter  902  includes teeth  904 , window  906 , first character  908 , and second character  910 . In  FIG. 9A , piston  610  engages flexible diaphragm  430 . Activation rod  620  is biased in the rest position by coil spring  640 . In the rest position, trigger mechanism body  730  maintains piston  610  in the down position such that micropump diaphragm  430  is biased downwards, such that it presses down on and actively closes inlet valve  440 , providing an extra measure of safety against over-delivery of insulin. As illustrated in  FIG. 9B , pressing activation rod  620  (as illustrated by arrow A 1 ), compresses coil spring  640 , pushing trigger mechanism body  730  forward. Pin  732  protrudes outwardly from trigger mechanism body  730 , and makes contact with tooth  904 , advancing the position of first character  908  and second character  910  in respect to window  906 . As trigger mechanism body  730  moves forward, piston  610  rises into ramp  740 , allowing flexible diaphragm  430  to move upward, inlet valve  440  to open, and fluid to flow into the pump chamber by way of pump inlet  500 . When activation rod  620  is released, coil spring  640  pushes trigger mechanism body  730  back towards the rest position, forcing piston  610  and flexible diaphragm  430  down, and closing inlet valve  440 . Each time trigger mechanism body  730  moves back and forth, pin  732  advances delivery counter  902  in the direction indicated by arrow A 2 , and displays a new character in window  906 . In this way, one can keep track of the number of pump cycles.  FIG. 10  illustrates a mechanism for resetting delivery counter  902 . Using a torsion spring  912  and detent  914 , delivery counter  902  is reset by first pressing in the direction indicated by arrow A 3 , then rotating delivery counter  902  in the direction indicated by arrow A 4  until first character  908  is displayed in window  906 . In this way, users can easily reset the delivery counter before delivering a dose of fluid. 
         [0045]    An advantage of the present invention is the ease with which the patient can use it. To set up the pump, the patient loads a pre-filled insulin cartridge  170  into insulin cartridge compartment  150  and closes cartridge door  130 . Next, the patient attaches mechanical pump  100  to adhesive patch platform  210 , establishing a fluid connection between mechanical pump  100  and flexible cannula  230 , and primes the device by holding down safety release button  120  and pressing delivery button  110  until a drop of insulin forms at the tip of flexible cannula  230 . The patient then removes the backing from adhesive patch platform  210 , secures the device to their skin, and pushes down on inserter lever  220  until it clicks in the down position. At this point the patient can deliver a fixed bolus of insulin on demand by holding down safety release button  120  and pressing delivery button  110 . If desired, delivery button  110  can be configured such that upon pressing delivery button  110 , the patient receives tactile and/or audible feedback to confirm that the button was pressed. Other than the simple priming step, the user does not have to perform any special steps to eliminate bubbles during setup or use of mechanical pump  100 , unlike the process for a conventional insulin pump. The design of the device allows for discrete operation through clothing without the need to see the device to deliver a bolus. After depleting insulin cartridge  170 , mechanical pump  100 , cartridge  170 , and adhesive patch platform  210  are removed and disposed of, and a new device is set up and attached to the skin. Alternatively, to reduce system cost, mechanical pump  100  can be re-used several times, reloading it with a new cartridge and attaching it to a new adhesive patch platform as necessary with each use. The device could be configured such that the patient can remove mechanical pump  100  while leaving adhesive patch platform  210  still attached to their body. This feature is useful if the patient wants to remove the pump temporarily for activities such as bathing or exercise, to change out insulin cartridges, or to check the pump if a problem is suspected. The pump can be reattached to adhesive patch platform  210  when desired by the patient. 
         [0046]    In the case where mechanical pump  100  is removed from adhesive patch platform  210 , with adhesive patch platform  210  still attached to the patient&#39;s body, it is desirable for fluid outlet from mechanical pump  100  and fluid inlet to flexible cannula  230  to be sealed when mechanical pump  100  is disconnected in order to prevent external fluid, debris, other contamination, or air from entering fluid outlet from mechanical pump  100  or fluid inlet to flexible cannula  230 . In conventional infusion pumps with disconnectable infusion sets, only the infusion set portion is sealed with a septum while the needle that is connected to the pump for piercing the septum remains open and vulnerable to air and contamination. A seal can be provided on both sides by incorporating a septum on both fluid outlet from mechanical pump  100  and fluid inlet to flexible cannula  230 , with a needle on one side that pierces both septums to establish a flow path when mechanical pump  100  is attached to adhesive patch platform  210 . 
         [0047]    Another advantage of the present invention is that it greatly simplifies insulin pump therapy to make it more broadly accessible while still providing beneficial safety features. Using direct micropump  320  to suck fluid from the insulin reservoir eliminates the mechanism that drives a plunger in a conventional indirect insulin pump. This greatly reduces the possibility of inadvertently driving the mechanism and over-delivering insulin. Conventional insulin pumps do not have any metering or flow-regulating device between the reservoir and the patient, making them vulnerable to failure modes such as siphoning and pressure differentials. In the present invention, micropump  320  is positioned between the insulin reservoir and the patient. Two normally closed valves  440  and  460  prevent unintentional insulin delivery. In addition, flexible diaphragm  430  is biased downwards by piston  610  in the rest position such that it presses down on and actively closes inlet valve  440 , providing an extra measure of safety against over-delivery of insulin. If the drive mechanism fails or is inadvertently activated in the present invention, at most one additional bolus will be delivered. In addition, micropump  320  and fluid lines between the pump and the patient have very low compliance; thus, if an occlusion occurs, pressure in the system rises very rapidly, and it will not be possible to press delivery button  110 , signaling the occlusion to the user. Safety release button  120  is an additional safety feature that prevents unintentional delivery. 
         [0048]    Another advantage of mechanical pump  100  is that it is very small compared to existing pumps. For patients undergoing basal/bolus insulin therapy, approximately half of the insulin they inject is basal and half is bolus. If mechanical pump  100  is used to deliver only bolus insulin, or only basal insulin, the insulin reservoir can be approximately half the size of the reservoir from a conventional insulin pump used for basal/bolus therapy. If the pump is used to deliver only basal or only bolus insulin, there will be less pooling of insulin at the infusion site compared to conventional pumps which deliver both basal and bolus insulin to the same site. This may allow for the cannula to be worn longer than the typical 2-3 days before replacement. In addition, mechanical pump  100  does not have electronics, on-board power, an actuator, or a display, allowing for further size reduction. Because mechanical pump  100  is very small, it can be worn comfortably and discretely beneath clothing. 
         [0049]    Another advantage of the present invention is that it is very low in cost compared to conventional insulin pumps, making the therapy accessible to more patients. The present invention is so low in cost that it can be disposable after each use. Thus, the user gets a new pump approximately every three days, improving reliability compared to conventional pumps which typically are expected to last for four years before replacement. 
         [0050]    Embodiments of the present invention also employ only mechanical energy input by a user (via a user activated delivery button) to deliver a therapeutic agent (e.g., insulin) to a user. These embodiments, therefore, do not require expensive electronics or cumbersome batteries. 
         [0051]    These and other objects and advantages of this invention will become obvious to a person of ordinary skill in this art upon reading of the detailed description of this invention including the associated drawings. 
         [0052]    Various other modifications, adaptations, and alternative designs are of course possible in light of the above teachings. Therefore, it should be understood at this time that within the scope of the appended claims the invention might be practiced otherwise than as specifically described herein.

Technology Classification (CPC): 0