Patent Description:
Embodiments of the present disclosure are directed at an insulin (or other substance) dispensing pump (e.g., a miniature pump, or patch pump), as well as an assistance device for at least one of reservoir filling and cannula insertion (for example).

Diabetes mellitus patients require administration of varying amounts of insulin throughout the day to control their blood glucose levels. Ambulatory portable insulin infusion pumps can be used as superior alternatives to multiple daily syringe injections of insulin. However, although these devices represent an improvement over multiple daily injections, they nevertheless all suffer from several drawbacks. One drawback is the large size and weight of the devices, caused by the configuration and the relatively large size of the driving mechanism and syringe. These relatively bulky devices have to be regularly carried in a patient's pocket or attached to his/her belt. Inserting of cannulas for transcutaneous delivery of insulin (and/or other substance), as well as reservoir filling of pumps, has also not been adequately addressed in current systems and devices. <CIT> discloses an apparatus for pumping fluid. <CIT> relates to a liquid medicine administration device.

Embodiments of the present disclosure are directed to miniature insulin patch pump and an assistance device for reservoir filling and cannula insertion. Although discussions of several embodiments in the current disclosure refer to insulin as the drug being delivered by the patch pump disclosed herein, it is to be understood that the use of the disclosed patch pump to other fluids/drugs is deemed to be within the scope of the inventive embodiments described herein.

In some embodiments of the present disclosure, a drug delivery system is provided and includes at least two or more, and in some embodiments, all of a drug-delivery patch pump, an assistance device configured for at least one of reservoir filling and cannula insertion, and, optionally, a gateway device.

Such embodiments may include one or more of (and in some embodiments, a plurality of, and in some embodiments, all of) the following additional features, functions, structures, and/or clarifications (as the case may be), creating yet further embodiments:.

In some embodiments, a substance/drug-delivery patch pump is provided and includes a reusable part (RP) including a power source, a driving mechanism, and an electronic module, and a disposable part (DP), where the disposable part can include at least a plurality of an adhesive base, a reservoir, a dosing mechanism, and a cannula.

In some embodiments, an assistance device is provided, which is configured for use with a drug delivery pump (e.g., patch pump). Such embodiments may comprise a housing that includes at least one of a reservoir filling mechanism, a cannula insertion mechanism, and/or a disposable part (DP), reusable part (RP) alignment mechanism.

In some embodiments, a drug delivery system is provided and includes at least one of a cannula insertion mechanism, and a reservoir filling mechanism. Such embodiments may include one or more of (and in some embodiments, a plurality of, and in some embodiments, all of) the following additional features, functions, structures, and/or clarifications (as the case may be), creating yet further embodiments:.

In some embodiments, a reservoir filling method for filling the reservoir of a drug delivery system with a substance, is provided and includes, for example, placing a vial in a vial adaptor such that a tip of a venting needle and a first tip of a filling needle pierce a septum of the vial, such that air from an interior of a cylinder flows through the venting needle and into the interior of the vial, pushing a plunger of the vial adaptor in a direction of a closed end of the cylinder, such that air trapped in the interior of the cylinder is reduced and/or compressed and a substance from the vial flows to a filling well and a filling conduit. As a result of a pressure differential across a reservoir plunger, the reservoir plunger then moves to increase a volume of the reservoir of the drug delivery system thereby filling the reservoir with the substance. The method also includes optionally sending a level of the substance within the reservoir, which may be used to provide a user information on the amount of substance in the reservoir.

In some embodiments, a patch pump assisting system is provided and includes an assisting device including a soft cannula insertion mechanism configured to at least insert a soft cannula in tissue. The device can comprise a housing, a first exit port septum configured within a cup opening, an exit port well, and a second exit port septum. The system can also further include a soft cannula having a lumen, and a rigid cannula having a lumen. In some embodiments:.

In some embodiments, a drug delivery patch-pump system is provided and includes, for example, a drug-delivery patch pump including a reservoir, a doser device, an assisting device according to any of the disclosed assisting device embodiments (and/or corresponding systems; e.g., see above). In some embodiments, upon filing the reservoir, the pump is configured for priming via the doser, such that, fluid is pumped through an exit port conduit into a filling port well, through the lumen of the rigid cannula, and out the lateral openings of each cannula. In some embodiments, the pump can be configured for continued priming until at least one of: substantially any and all air exits the doser and/or reservoir, and the drug being delivered begins to flow from the lateral openings of the cannulas.

In some embodiments, a method for inserting a soft cannula for a drug delivery system into the tissue of a user is provided, for example, and includes triggering a trigger of a cannula insertion mechanism such that one or more safety catches release energy stored in an inserter spring of the inserter mechanism such that an inserter hammer of the inserter mechanism is driven in a first direction, a cup, a cup opening, a cup septum, a rigid cannula and a soft cannula of the inserter mechanism move towards a patient's skin, and a tip of a rigid cannula punctures the skin establishing a path for a soft cannula. In some embodiments, upon an end of the cup residing on an end of cup septum, the cup placed in the cup opening, and lateral openings of the rigid and the soft cannulas being in fluid communication with an exit port well, and corresponding ends of the rigid cannula and the soft cannula are under the patient's skin, the assisting device can be removed while removing the rigid cannula from the lumen of the soft cannula.

In some such method embodiments, the energy stored in a cannula bending spring can be released upon separation of the assistance device form a drug/substance delivery system. Additionally, in some embodiments, the method further includes providing one and/or another of assisting devices disclosed herein (e.g., see above), and/or corresponding systems.

In some embodiments, a closed loop insulin delivery system is provided and includes, for example, a pump, a controller, a charger, and an assistance device. Such embodiments may include one or more of (and in some embodiments, a plurality of, and in some embodiments, all of) the following additional features, functions, structures, and/or clarifications (as the case may be), creating yet further embodiments:.

In some embodiments, a continuous glucose sensor configured for use with a closed loop delivery system according to any one or more of the embodiments disclosed herein. Such embodiments include, for example, one or more of (and in some embodiments, a plurality of, and in some embodiments, all of) the following additional features, functions, structures, and/or clarifications (as the case may be), creating yet further embodiments:.

In some embodiments, an assistance device for reservoir filling and cannula insertion for use with a drug delivery device is provided and includes, for example, a filling mechanism, and an insertion mechanism configured to subcutaneously insert both a cannula and a continuous glucose sensor. In some such embodiments, the device can further include an inserter hammer configured to, in some embodiments, simultaneously deploy the cannula and the sensor, optionally through a drug delivery pump (and optionally via a channel), through a user's skin. Additionally, the hammer can comprise a plurality of hammers each configured to insert one of the cannula and the sensor.

In some embodiments, a method of operating a drug delivery system is provided and includes, for example, at least one of, in some embodiments, a plurality of, and in some embodiments, all of: inserting a motor unit of a drug delivery system into a slot of an assistance device, where a pump from the motor until can be assembled with a cannula unit of the system, filling the pump with insulin via an insulin filling mechanism, priming the pump, exposing an adhesive on a skin-facing side of the pump by peeling a liner therefrom, placing the pump on the user's skin at a desired location via an assistance device, and once the pump is adhered to the skin, triggering the cannula unit such that the cannula and the sensor are inserted into the user. Insertion can occur via elastic energy stored in a spring, force generated by the spring may be transmitted to the cannula and the sensor via at least one hammer.

Some embodiments of the present disclosure are directed to system(s) or device(s) according to any of the embodiments described and/or illustrated in any one or more of <FIG>.

Some embodiments of the present disclosure are directed to a method(s) according to any of the embodiments described herein, and/or illustrated in any one or more of <FIG>.

Support for further embodiments, as well as for one and/or another of certain features/functionality disclosed herein, and features/functionality which may be combined with features/functionality of the present disclosure (to yield yet further embodiments), can be found with reference to:.

<FIG> shows components of insulin delivery system <NUM>, according to some embodiments of the present disclosure. The system includes at least one of the following components (and in some embodiments, two or more of, and in some embodiments, all of): insulin patch pump <NUM> (also referred to as a pump, substance delivery pump, drug delivery pump, and the like), controller <NUM>, charger <NUM>, and assistance device <NUM>. In some embodiments, the controller <NUM> remotely commands the patch pump <NUM> and receives alerts and alarms from the patch pump <NUM>. The controller <NUM> can include a user interface(s) such as touch screen and operating buttons. The controller <NUM> may also communicate with other drug/diabetes management devices (e.g., glucose meters), BLE enabled devices (PC, smartphone, tablets, etc.) and the cloud. In addition, in some embodiments, the controller may comprise a smartphone and the like.

The patch pump <NUM>, in some embodiments, includes a reusable part (RP) <NUM> and a disposable part (DP) <NUM>. The RP <NUM> can include one or more of (and depending upon the embodiments, two or more of, or all of) the driving mechanism, electronics, and power source (e.g., battery). The DP <NUM> can include all or a plurality of an adhesive base, reservoir, pumping mechanism, filling port, exit port, and a cannula(s).

Insulin (and/or another drug or substance) can be configured for delivery from the reservoir to the exit port, and from the exit port through the cannula into the body (in some embodiments). The power source, within the RP <NUM> (but in some embodiments, may be included in the DP - and be a single time use battery) may be charged with a charger <NUM>. The assistance device <NUM> may be used for at least one of: to connect the RP <NUM> and DP <NUM>, filling the reservoir, adhering the patch pump <NUM> to the skin, and cannula insertion. After cannula insertion the assistance device <NUM> can be discarded.

<FIG> shows the disconnected components of the patch pump <NUM>: the RP <NUM> and the DP <NUM>, according to some embodiments. As shown, the DP <NUM> includes the adhesive base <NUM>, reservoir <NUM>, and doser <NUM>. Insulin can be delivered from the reservoir <NUM> to the doser <NUM>, and from the doser <NUM> through the cannula (not shown) into the user's body. According to some embodiments, before operation, the user connects the RP <NUM> and the DP <NUM> (forming the patch pump <NUM>), fills the reservoir <NUM>, adheres the patch pump <NUM> to the skin, and inserts the cannula (not shown). At the end of the operation cycle (from patch pump mounting to patch pump removal, i.e., about <NUM>-<NUM> days), the user removes the patch pump <NUM> from the skin, disconnects the RP <NUM> from the DP <NUM>, and disposes the DP <NUM>. In some embodiments, the patch pump may be provided in a kit, which includes at least two RPs <NUM> so that upon one RP <NUM> being operated (connected to the DP and adhered to the user body) the second RP <NUM> is charging. Accordingly, at the end of one operation cycle, a new DP <NUM> is connected to the charged RP <NUM> (second RP) and the used RP (first RP) is charged.

<FIG> shows a spatial view of the assistance device <NUM> according to some embodiments. The assistance device <NUM> may include at least one of (and in some embodiments, two or more of, and in some embodiments, all of) a vial connector <NUM>, RP notch <NUM>, trigger <NUM>, safety catch(es) <NUM>. In one preferred embodiment, the DP (reservoir <NUM> and adhesive base <NUM> are shown) is preassembled to the bottom side of the assistance device <NUM>. The adhesive base <NUM> can includes two adhesive/sticky surfaces, a bottom surface for adhering the patch pump <NUM> to the skin, and an upper surface for securing the DP <NUM> to the RP <NUM> (e.g., after DP-RP connection). The assistance device <NUM> can include at least one of: a reservoir filling mechanism (<NUM> in <FIG>), a cannula insertion mechanism (<NUM> in <FIG>), and DR-RP alignment mechanism. The insertion mechanism may be activated by concomitant pressing on the trigger <NUM> and safety catches <NUM> (only one side is shown). The reservoir filling mechanism may be activated by connection of an insulin vial to the vial connector <NUM> and pressing the vial against the vial connector <NUM>. The RP notch <NUM> may be configured to provide alignment between the RP <NUM> and DP <NUM> during RP-DP connection. The RP <NUM> (not shown) may be configured to slide over the reservoir <NUM> and connect to the DP <NUM> within the assistance device <NUM>.

<FIG>show the patch pump (A) and cross section views of the DP <NUM> (B-D), according to some embodiments. <FIG> shows the patch pump <NUM> that includes, for example, the RP <NUM> (dashed dotted line) and DP <NUM>. The DP <NUM> can include at least a plurality of (and in some embodiments, all of): reservoir <NUM>, reservoir plunger <NUM>, doser <NUM>, doser plunger <NUM>, filling conduit <NUM>, filling port septum <NUM>, filling port well <NUM>, exit port conduit <NUM>, exit port well <NUM>, cannula <NUM>, cannula septum <NUM>, cannula opening <NUM>, and reservoir-doser conduit <NUM>.

Filling of reservoir <NUM> (in this case, insulin, but can be any substance for delivery into tissue of a user) may be done with a designated syringe (not shown), or with the assistance device <NUM> (<FIG> and <FIG>). With the syringe, the user draws insulin from a vial, pierces the filling port septum <NUM> with the syringe needle, and injects insulin into the filling port well <NUM> and through the filling conduit <NUM> into the reservoir <NUM> (i.e. the syringe is a "transporting tool" for insulin delivery from the vial to the patch pump reservoir <NUM>). With the assistance device <NUM>, insulin can be directly delivered from the vial into the patch pump reservoir <NUM> (no "transporting tool"), insulin is delivered through the filling port septum <NUM> into the filling port well <NUM>, and through the filling conduit <NUM> into the reservoir <NUM>.

The amount of insulin that is drawn from the vial and injected into the reservoir <NUM> can depend on the user's insulin daily consumption and the predicted days of use. For example, if the daily consumption is <NUM> units/day (50U/day) and the replacement cycle (time between replacements) is <NUM> days, the total required insulin amount is 150U (50U x 3days). Insulin is delivered from the well <NUM>, through the filling conduit <NUM> into the reservoir <NUM>. During reservoir <NUM> filling, the reservoir plunger <NUM> is displaced in the direction of the bold arrow to its final position (downward diagonal lines). The final position of the reservoir plunger <NUM> is configured to depend on the amount of insulin that the user injects into the reservoir <NUM>. In <FIG>, the reservoir may be marked with four graduations (50U, 100U, 150U, and 200U), the reservoir is filled with 150U and the final position of the reservoir plunger <NUM> (downward diagonal lines) is at the mark of 150U.

During patch pump <NUM> operation, the doser plunger <NUM> can be configured to be displaced backward and forward by the RP driving mechanism (not shown). When the doser plunger <NUM> is displaced backward, insulin can be delivered through the reservoir-doser conduit <NUM> into the doser <NUM>. When the doser plunger <NUM> is displaced forward, insulin can be delivered from the doser <NUM> through the exit port conduit <NUM>, exit port well <NUM>, cannula opening <NUM>, and cannula <NUM> into the user's body.

<FIG> show cross section views of the DP <NUM> through cross section planes (dotted lines) y-y (4B), z-z (4C), and x-x (4D), respectively. <FIG> shows a longitudinal cross section view of plane y-y of <FIG>. The DP <NUM> includes the reservoir <NUM>, reservoir plunger <NUM> (before filling - black, and after filling with 150U of insulin - downward diagonals), filling conduit <NUM>, filling port septum <NUM>, and filling port well <NUM>. <FIG> shows a longitudinal cross section view of plane z-z of <FIG> (after cannula <NUM> insertion). The DP <NUM> includes the doser <NUM>, doser plunger <NUM>, exit port conduit <NUM>, exit port well <NUM>, cannula <NUM>, cannula septum <NUM>, and cannula opening <NUM>. During insulin administration to the user, insulin can be delivered from the doser <NUM> through the exit port conduit <NUM>, exit port well <NUM>, cannula opening <NUM>, and cannula <NUM> into the user's body. Before insertion of cannula <NUM> (<FIG>), the cannula septum <NUM> and cannula opening <NUM> are situated externally to the DP <NUM> and the cannula <NUM> tip is situated within the DP <NUM>. In some embodiments, the DP <NUM> can be preassembled with the assistance device (<FIG>, <FIG>), and after reservoir <NUM> filling and DP-RP connection (within the assistance device), the patch pump <NUM> is adhered to the user's skin with the assistance device and the cannula <NUM> is inserted by activation of the cannula insertion mechanism (<FIG>).

In some embodiments, during cannula insertion, the cannula <NUM>, and cannula opening <NUM> are downwardly displaced to the position shown in <FIG> - cannula septum <NUM> is sealing the exit port well <NUM>, cannula opening <NUM> is situated within the exit port well <NUM>, and the tip of cannula <NUM> is situated below the bottom of the DP <NUM>. <FIG> shows a transverse cross section view of plane x-x of <FIG>. The DP <NUM> includes the filling port septum <NUM>, filling port well <NUM>, exit port well <NUM>, cannula <NUM>, cannula septum <NUM>, and cannula opening <NUM>.

<FIG> shows a scheme of the main components of the assistance device <NUM> and the preassembled DP <NUM>. In some embodiments, the assistance device <NUM> can include at least one of the reservoir filling mechanism <NUM>, and the cannula insertion mechanism <NUM>. In another embodiment (not shown), insulin filling and cannula insertion can be performed with two separated devices, a filling device and an insertion device (inserter), where each device can have (and in some embodiments has) a separate housing. The filling device can be configured with a reservoir filling mechanism <NUM>, and the insertion device has a cannula insertion mechanism <NUM>. Hereinafter, the reservoir filling mechanism <NUM>, with respect to at least one and/or another of embodiments of the disclosure, may interchangeably be part of the assistance device <NUM> (including the insertion mechanism <NUM>) or a standalone filling device having a separate housing and a separate reservoir filling mechanism <NUM>.

The assistance device <NUM> shown in <FIG> includes the preassembled DP <NUM>, the reservoir filling mechanism <NUM>, and the cannula insertion mechanism <NUM>. The reservoir filling mechanism <NUM> may include at least one of (and in some embodiments, two or more of, and in some embodiments, all of) the vial adaptor <NUM>, filling needle <NUM>, venting needle <NUM>, filling piston <NUM>, filling interspace <NUM>, transferring needle <NUM>, piston spring <NUM>, and venting aperture <NUM>. The cannula insertion mechanism <NUM> may include trigger <NUM>, inserter spring <NUM>, and inserter hammer <NUM>. The DP <NUM> may include the filling port septum <NUM>, filling port well <NUM>, exit port well <NUM>, cannula <NUM>, cannula septum <NUM>, and cannula opening <NUM>. Accordingly, after cannula insertion, the cannula septum <NUM> is configured to seal exit port well <NUM>, cannula opening <NUM> is situated within the exit port well <NUM>, and tip of cannula <NUM> is situated below the bottom of the DP <NUM> (<FIG>). <FIG> shows the reservoir filling mechanism <NUM> during the interspace <NUM> filling phase (phase <NUM>, <FIG> and <FIG>), the vial <NUM> is connected to the vial adaptor <NUM> and insulin is delivered from the vial <NUM> into the interspace <NUM>. The transferring needle <NUM> pierces the filling port septum <NUM> and the tip of the transferring needle <NUM> is position within the filling port well <NUM>.

<FIG><FIG>show spatial views of the assistance device <NUM> (<FIG>) and the operation phases of the reservoir filling mechanism (<FIG>), according to some embodiments. First, vial connection (7A) -- vial <NUM> is connected to the vial adaptor <NUM>, second, interspace filling (7B) - vial is pressed downward and insulin is delivered from the vial into the interspace <NUM>. Third, reservoir filling (8A) - pressure is removed from the vial <NUM>, vial <NUM> is retracted, and insulin is delivered from the interspace <NUM> to the reservoir <NUM>. Four, Vial disconnection (8B) - vial <NUM> is removed from the assistance device <NUM>.

<FIG> shows a spatial view of the assistance device <NUM> according to some of the embodiments. The assistance device <NUM> includes the trigger, <NUM>, safety catches <NUM>, and vial connector <NUM>. The vial connector <NUM> may comprise the vial adaptor <NUM> and the needles protector <NUM>.

<FIG> shows a spatial view of the assistance device <NUM> at phase <NUM> of the reservoir filling (vial connection), according to some embodiments. The assistance device includes the trigger, <NUM>, safety catches <NUM>, and vial connector <NUM> (vial adaptor <NUM> and the needles protector <NUM>). During phase <NUM> of reservoir filling, the vial <NUM> is connected to the vial adaptor <NUM> (operation scheme in <FIG>).

<FIG> shows a spatial view of the assistance device <NUM> at phase <NUM> of the reservoir filling (interspace filling), according to some embodiments. The assistance device may include trigger <NUM>, safety catche(s) <NUM>, and vial connector <NUM> (vial adaptor <NUM> and the needles protector <NUM>). During phase <NUM> of reservoir filling, the vial <NUM> may be forced downward in the direction of the bold arrow. Insulin may now be delivered from the vial <NUM> into the interspace <NUM> (operation scheme in <FIG>).

<FIG> shows a spatial view of the assistance device <NUM> at phase <NUM> of the filling process (reservoir filling), according to some embodiments. The assistance device <NUM> includes trigger <NUM>, safety catches <NUM>, and vial connector <NUM> (vial adaptor <NUM> and needles protector <NUM>). During phase <NUM> of filling process, the vial <NUM> can be retracted in the direction of the bold arrow. Insulin is delivered from the interspace <NUM> into the reservoir <NUM> (operation scheme in <FIG>).

<FIG> shows a spatial view of the assistance device <NUM> at phase <NUM> of the filling process (vial disconnection), according to some embodiments. The assistance device <NUM> includes trigger, <NUM>, safety catches <NUM>, and vial connector <NUM> (vial adaptor <NUM> and needles protector <NUM>). During phase <NUM> of the filling process, the vial <NUM> is removed from the assistance device <NUM> (operation scheme in <FIG>).

<FIG> show schemes of the reservoir filling mechanism <NUM> of the assistance device <NUM> (<FIG>) and the operation phases (phase <NUM> → phase <NUM>) of the reservoir filling (<FIG>), according to some embodiments. <FIG> shows a scheme of a cross section of the reservoir filling mechanism <NUM>. The reservoir filling mechanism <NUM> may include a plurality of, and preferably all of, the vial adaptor <NUM>, sliding rod <NUM>, sliding rod opening <NUM>, filling needle <NUM>, venting needle <NUM>, filling piston <NUM>, filling interspace <NUM>, piston conduit <NUM>, transferring needle <NUM>, piston gasket <NUM>, interspace gasket <NUM>, first unidirectional valve <NUM>, second unidirectional valve <NUM>, third unidirectional valve <NUM>, transferring needle <NUM>, graduation marks <NUM>, filling sleeve <NUM>, piston spring <NUM>, and venting aperture <NUM>. In some embodiments, the reservoir filling mechanism <NUM> can be preassembled with the DP <NUM> within the assistance device <NUM> (not shown).

The DP <NUM> may also include a plurality of and preferably all of the filling port septum <NUM>, filling port well <NUM>, filling conduit <NUM>, reservoir <NUM>, and reservoir plunger <NUM>. The transferring needle <NUM> is configured to pierce the filling port septum <NUM>, with the tip of the transferring needle <NUM> residing within the filling port well <NUM>. The vial adaptor <NUM> may be connected with the filling piston <NUM> via the cylindrically shaped sliding rod <NUM>. The filling sleeve <NUM> may comprise at least one of, and in some embodiments, a plurality of, and in some embodiments, all of, a cylinder that can include a plurality of and preferably all of the piston spring <NUM>, filling piston <NUM>, venting aperture <NUM>, and filling sleeve opening <NUM>. The interspace gasket <NUM> may be connected to the filling sleeve opening <NUM> providing sealing of the interspace <NUM> when the sliding rod <NUM> is linearly displaced (in the direction of the bold arrows X and Y) within the filling sleeve opening <NUM>. The filling piston <NUM> may include a gasket <NUM> that provides sealing of the interspace <NUM> when the filling piston <NUM> is linearly displaced within the filling sleeve <NUM>. Displacement of the filling piston <NUM> in the direction of the bold arrow X is configured to increase the volume of the interspace <NUM> and compresses the piston spring <NUM>, displacement of the filling piston <NUM> in the direction of the bold arrow Y decreases the volume of the interspace <NUM> and decompressed the piston spring <NUM>. The filling needle <NUM> preferably includes a sharp tip and traverses the sliding rod <NUM>. The filling needle <NUM> may include one-way hydraulic communication with the interspace <NUM> via the piston conduit <NUM> that traverses the filling piston <NUM>.

The first unidirectional valve <NUM> provides one way of insulin delivery from the tip of the filling needle <NUM> through the piston conduit <NUM> to the interspace <NUM>. The interspace <NUM> preferably includes a one-way hydraulic communication with the reservoir <NUM> via the transferring needle <NUM>, filling port well <NUM>, reservoir filling conduit <NUM>, and the reservoir <NUM>. The second unidirectional valve <NUM> preferably provides one way of insulin delivery from the interspace <NUM> to the reservoir <NUM> via the transferring needle <NUM>, filling port well <NUM>, and reservoir filling conduit <NUM>. The venting needle <NUM> preferably includes a sharp tip and transverses the sliding rod <NUM>. The venting needle <NUM> is configured to provide air communication between the filling sleeve <NUM> and the tip of the venting needle <NUM>. In some embodiments, a third unidirectional valve <NUM> can be provided, which may be arranged at the end of the venting needle <NUM> within the piston sleeve <NUM>. The third unidirectional valve <NUM> is configured to provide one-way air delivery from the atmosphere into the vial <NUM> and prevents inadvertent insulin delivery if the pressure within the vial <NUM> is above atmospheric pressure (this can happen if, for example, the vial was filled with air by using a syringe for reservoir filling).

The venting aperture <NUM> is configured to provide atmospheric pressure (P) equilibrium between the atmosphere and the filling sleeve <NUM>. When the vial is not connected to the vial adaptor <NUM>, the pressure at the tip of the venting needle <NUM> is atmospheric pressure (P) and there is no air movement along the venting needle <NUM>. The sliding rod <NUM> is preferably configured with graduation marks <NUM> that provide the user with an indication of the volume of insulin that is delivered from the vial <NUM> into the reservoir <NUM> (according to the required insulin consumption during the operation cycle (i.e. <NUM>-<NUM> days). <FIG> shows an example of marks - <NUM>, <NUM>, <NUM>, and <NUM> insulin units. During the filling process, the user presses the vial <NUM> and displaces the vial adaptor <NUM> and the sliding rod <NUM> in the direction of the bold arrow X. The extent of displacement (linear movement of the sliding rod <NUM> and the filling piston <NUM>) is configured to correlate with the amount of insulin delivered from the vial <NUM> into the reservoir <NUM>. For example - if the required amount is <NUM> units (150U), the user presses the vial <NUM> and the sliding rod <NUM> to the level of the <NUM> units mark. In another embodiment, the reservoir filling mechanism <NUM> can be provided with a volume setting knob (not shown) that is positioned on the sliding rod <NUM>. Rotation of the knob by the user in one direction or the opposite direction (e.g., clockwise or counterclockwise) increases or decreases the insulin amount to be delivered respectively. The graduations can be marked on the knob (i.e. 0U-200U). The user rotates the volume setting knob to the desired amount (i.e. <NUM> units) and presses the vial <NUM> (<FIG>). In another preferred embodiment, the amount of insulin delivered from the vial <NUM> into the reservoir <NUM> can be preset to a fixed quantity (i.e. <NUM> insulin units). The extent of downward displacement (bold arrow X) of the sliding rod <NUM> can be preset and accordingly the amount of insulin delivered from the vial <NUM> into the reservoir <NUM> in one press is preset. The total amount of delivered insulin = Quantum (in insulin units) x number of presses. For example, if the fixed quantum is <NUM> units (50U) and the user requirement for one replacement cycle (i.e. <NUM>-<NUM> days) is <NUM> units (150U), the user should press the vial <NUM> times (50U x <NUM> = 150U). In the example shown in <FIG>, if the maximal volume of the reservoir is 200U, then, accordingly, for achieving a full reservoir, the maximal number of presses is <NUM> (50U x <NUM> = 200U).

<FIG> shows a cross-section of the reservoir filling mechanism <NUM> at phase <NUM> of the filling process (vial connection), according to some embodiments. The reservoir filling mechanism <NUM> includes a plurality of, and preferably all of, the vial adaptor <NUM>, sliding rod <NUM>, sliding rod opening <NUM>, filling needle <NUM>, venting needle <NUM>, filling piston <NUM>, filling interspace <NUM>, piston conduit <NUM>, transferring needle <NUM>, piston gasket <NUM>, interspace gasket <NUM>, first unidirectional valve <NUM>, second unidirectional valve <NUM>, third unidirectional valve <NUM>, transferring needle <NUM>, graduation marks <NUM>, filling sleeve <NUM>, piston spring <NUM>, and venting aperture <NUM>. The reservoir filling mechanism <NUM> provides delivery of insulin from the vial <NUM> to the reservoir <NUM> (that resides within the DP <NUM>) through the transferring needle <NUM>. The DP <NUM> includes a plurality of, and preferably all of, the filling port septum <NUM>, filling port well <NUM>, filling conduit <NUM>, reservoir <NUM>, and reservoir plunger <NUM>. At phase <NUM> of the filling process, the vial <NUM> is connected to the vial adaptor <NUM>. The filling needle <NUM> and venting needle <NUM> pierce the rubber septum of the vial cover <NUM>.

<FIG> shows a scheme of a cross section of the reservoir filling mechanism <NUM> at phase <NUM> of the filling process (interspace filling), according to some embodiments. The reservoir filling mechanism <NUM> includes a plurality of, and preferably all of, the vial adaptor <NUM>, sliding rod <NUM>, sliding rod opening <NUM>, filling needle <NUM>, venting needle <NUM>, filling piston <NUM>, filling interspace <NUM>, piston conduit <NUM>, transferring needle <NUM>, piston gasket <NUM>, interspace gasket <NUM>, first unidirectional valve <NUM>, second unidirectional valve <NUM>, third unidirectional valve <NUM>, transferring needle <NUM>, graduation marks <NUM>, filling sleeve <NUM>, piston spring <NUM>, and venting aperture <NUM>. The DP <NUM> includes a plurality of, and preferably all of, the filling port septum <NUM>, filling port well <NUM>, filling conduit <NUM>, reservoir <NUM>, and reservoir plunger <NUM>. At phase <NUM> of the filling process, the vial <NUM> is pressed in the direction of the bold arrow, and, concomitantly, the sliding rod <NUM> and the filling piston <NUM> are displaced in the same direction (bold arrow). The displacement of the filling piston <NUM> creates a negative pressure within the interspace <NUM> that is hermetically sealed by the piston gasket <NUM> and interspace gasket <NUM>. Insulin (wavy lines) in the vial <NUM> follows the pressure gradient and is delivered in the direction of the dashed line arrow X through the filling needle <NUM>, piston conduit <NUM>, and first unidirectional valve <NUM> into the interspace <NUM>.

In the example of <FIG>, the sliding rod <NUM> can be displaced to the <NUM> units mark, and accordingly, the interspace <NUM> is filled with <NUM> units of insulin. During displacement of the filling piston <NUM>, the piston spring <NUM> is compressed. The second unidirectional valve <NUM> can be configured to prevent air from getting into the interspace and creating air bubbles. During insulin delivery from the vial <NUM> into the interspace <NUM>, the pressure within the vial <NUM> drops below the atmospheric pressure (P-). Following the pressure drop (P-) within the vial, air follows the pressure gradient and is delivered in the direction of the dashed line arrow Y from the filling sleeve <NUM> through the venting needle <NUM> and into the vial <NUM> through optional third valve <NUM>. At the end of filling phase <NUM>, the pressure within the vial <NUM> is the atmospheric pressure.

<FIG> shows a scheme of a cross section of the reservoir filling mechanism <NUM> at phase <NUM> of the filling process (reservoir filling), according to some embodiments. The reservoir filling mechanism <NUM> includes a plurality of, and preferably all of, the vial adaptor <NUM>, sliding rod <NUM>, sliding rod opening <NUM>, filling needle <NUM>, venting needle <NUM>, filling piston <NUM>, interspace <NUM>, piston conduit <NUM>, transferring needle <NUM>, piston gasket <NUM>, interspace gasket <NUM>, first unidirectional valve <NUM>, second unidirectional valve <NUM>, transferring needle <NUM>, graduation marks <NUM>, filling sleeve <NUM>, piston spring <NUM>, and venting aperture <NUM>. The DP <NUM> includes a plurality of, and preferably all of. The filling port septum <NUM>, filling port well <NUM>, filling conduit <NUM>, reservoir <NUM>, and reservoir plunger <NUM>. At phase <NUM> of the filling process, the pressure applied by the user on the vial <NUM> is removed, releasing stored energy within the compressed piston spring <NUM>. The filling piston <NUM>, sliding rod <NUM>, and vial adaptor <NUM> are displaced in the direction of the bold arrows. The movement of the filling piston <NUM> decreases the volume of the interspace <NUM> and insulin that was momentarily stored in the interspace <NUM> is displaced from the interspace <NUM> and delivered in the direction of the dashed line arrow X through the second unidirectional valve <NUM>, transferring needle <NUM>, filling port well <NUM>, filling conduit <NUM> and into the reservoir <NUM>. During the reservoir <NUM> filling, the reservoir plunger <NUM> is displaced in the direction of the thin arrow towards the rear side of the reservoir <NUM>. The first unidirectional valve <NUM> can be configured to prevent reverse insulin delivery from the interspace <NUM> into the insulin vial. The pressure (P) within the vial <NUM> remains equal to the atmospheric pressure within the filling sleeve <NUM>.

<FIG> shows a scheme of a cross section of the reservoir filling mechanism <NUM> at phase <NUM> of the filling process (vial disconnection), according to some embodiments. The reservoir filling mechanism <NUM> includes a plurality of, and preferably all of, the vial adaptor <NUM>, sliding rod <NUM>, filling needle <NUM>, venting needle <NUM>, filling piston <NUM>, interspace <NUM>, piston conduit <NUM>, transferring needle <NUM>, piston gasket <NUM>, interspace gasket <NUM>, first unidirectional valve <NUM>, second unidirectional valve <NUM>, third unidirectional valve <NUM>, transferring needle <NUM>, graduation marks <NUM>, filling sleeve <NUM>, piston spring <NUM>, and venting aperture <NUM>. The DP <NUM> includes a plurality of, and preferably all of, the filling port septum <NUM>, filling port well <NUM>, filling conduit <NUM>, reservoir <NUM>, and reservoir plunger <NUM>. At phase <NUM> of the filling process the vial <NUM> is removed (curved bold arrow). The pressure within the removed vial <NUM> is equal to the atmospheric pressure and the vial <NUM> is ready for another filling cycle.

<FIG> shows a scheme of a cross section of the DP <NUM> after completion of the filling process and after cannula insertion and removal of the assistance device <NUM> from the user skin <NUM> (cannula insertion mechanism, cannula insertion, and the cannula are not shown), according to some embodiments. The DP <NUM> can include a plurality of, and preferably all of, the adhesive base <NUM>, filling port septum <NUM>, filling port well <NUM>, filling conduit <NUM>, reservoir <NUM>, and reservoir plunger <NUM>. The reservoir <NUM> is filled (waves) and the reservoir plunger <NUM> is at the rear position. The reservoir is filled with <NUM> units of insulin (150U) (as shown in the examples mentioned in <FIG>).

<FIG> show cross-section views of the reservoir filling mechanism <NUM> and the DP <NUM> (<FIG>) and the standalone reservoir filling mechanism <NUM> (<FIG>), according to some embodiments. <FIG> shows a cross-section view of the reservoir filling mechanism <NUM> and the DP <NUM>. The reservoir filling mechanism <NUM> can include a plurality of, and preferably all of, the vial adaptor <NUM>, needles protector <NUM>, sliding rod <NUM>, filling needle <NUM>, venting needle <NUM>, filling piston <NUM>, interspace <NUM>, piston conduit <NUM>, transferring needle <NUM>, piston gasket <NUM>, interspace gasket <NUM>, first unidirectional valve <NUM>, second unidirectional valve <NUM>, transferring needle <NUM>, filling sleeve <NUM>, piston spring <NUM>, and venting aperture <NUM>. The DP <NUM> includes a plurality of, and preferably all of, the filling port septum <NUM>, filling port well <NUM>, filling conduit <NUM>, reservoir <NUM>, and reservoir plunger <NUM>. The needles protector <NUM> may comprise a petal-like shaped spring with banding "leaves" (e.g., one or more leaves). In some embodiments, four leaves are interposed within the vial adaptor <NUM>, each comprising a "leaf" (e.g., four leaves), preferably a rigid leaf (spatial views in <FIG>). The vial adaptor <NUM> may be displaced linearly down and up (bold arrows X and Y) relative to the needle protector <NUM>. Before connection of the vial <NUM> to the vial adaptor <NUM>, the leaves of the needle protector are parallel to the filling needle <NUM> and the venting needle <NUM>. After vial <NUM> removal, the leaves of the needles protector <NUM> and reconfigured to bend over both needles <NUM> and <NUM>, thereby protecting the user from inadvertent self-pricking (<FIG>).

<FIG> shows a magnified cross section view of the reservoir filling mechanism <NUM> before vial connection, according to some embodiments. The reservoir filling mechanism <NUM> includes a plurality of, and preferably all of, the vial adaptor <NUM>, needles protector <NUM>, sliding rod <NUM>, filling needle <NUM>, venting needle <NUM>, filling piston <NUM>, interspace <NUM>, piston conduit <NUM>, transferring needle <NUM>, piston gasket <NUM>, interspace gasket <NUM>, first unidirectional valve <NUM>, second unidirectional valve <NUM>, transferring needle <NUM>, filling sleeve <NUM>, piston spring <NUM>, and venting aperture <NUM>. Leaves of the needles protector <NUM> are shown before vial <NUM> connection (continuous lines <NUM>) and after vial <NUM> disconnection (dashed lines <NUM>).

<FIG>show cross section views of the reservoir filling mechanism <NUM> at first three phases of the filling process, according to some embodiments: phase <NUM> - vial connection (17A), phase <NUM> - interspace filling (17B), and phase <NUM> - reservoir filling (17C). <FIG> (cross section views) correspond to <FIG> (schemes) respectively: <FIG>, <FIG>, and <FIG>. The reservoir filling mechanism <NUM> includes a plurality of, and preferably all of, the vial adaptor <NUM>, needles protector <NUM>, sliding rod <NUM>, filling needle <NUM>, venting needle <NUM>, filling piston <NUM>, interspace <NUM>, piston conduit <NUM>, transferring needle <NUM>, piston gasket <NUM>, interspace gasket <NUM>, first unidirectional valve <NUM>, second unidirectional valve <NUM>, optional third unidirectional valve <NUM> (not shown), transferring needle <NUM>, filling sleeve <NUM>, piston spring <NUM>, and venting aperture <NUM>. <FIG> shows phase <NUM> of the filling process - vial <NUM> connection. The vial <NUM> is connected to the vial adaptor <NUM>, the filling needle <NUM> and the venting needle <NUM> pierce the vial rubber seal (shown in <FIG> and <FIG>), and the tips of the filling needle <NUM> and the venting needle are in contact with the vial content (i.e. insulin).

<FIG> shows phase <NUM> of the filling process - interspace <NUM> filling, according to some embodiments. The vial <NUM> is pressed by the user in the direction of the bold arrow (downward) to the amount that corresponds to the desired amount of insulin to be filled in the reservoir (i.e. if the required amount is 150U, the vial should be pressed until the 150U mark is approached (<FIG>)). The sliding rod <NUM> and filling piston <NUM> are displaced in the direction of the bold arrow and the piston spring <NUM> is compressed. Insulin is delivered from the vial <NUM> via the filling needle <NUM>, the piston conduit <NUM> and the first unidirectional valve <NUM> into the interspace <NUM>. Air follows the pressure gradient and is delivered through the venting needle <NUM> from the filling sleeve <NUM> (atmospheric pressure) to the vial <NUM> (sub-atmospheric pressure). At the end of the interspace filling phase, the interspace <NUM> is filled with the desire amount of insulin and the pressure within the vial <NUM> is atmospheric pressure. <FIG> shows phase <NUM> of the filling process, which also includes reservoir filling. Accordingly, the pressure from the vial <NUM> is removed and the filling piston <NUM>, sliding rod <NUM>, and vial adaptor <NUM> are displaced in the direction of the bold arrow (release of energy that was stored in the piston spring <NUM> during phase <NUM>). The volume of interspace <NUM> is decreased and insulin is displaced from the interspace <NUM> into the reservoir (<FIG>) via the second unidirectional valve <NUM> and the transferring needle <NUM>.

<FIG> shows a magnified cross-section view of the reservoir filling mechanism <NUM> after the filling process is completed and the vial is disconnected, according to some embodiments. The reservoir filling mechanism <NUM> includes a plurality of, and preferably all of, the vial adaptor <NUM>, needles protector <NUM>, sliding rod <NUM>, filling needle <NUM>, venting needle <NUM>, filling piston <NUM>, interspace <NUM>, piston conduit <NUM>, transferring needle <NUM>, piston gasket <NUM>, interspace gasket <NUM>, first unidirectional valve <NUM>, second unidirectional valve <NUM>, transferring needle <NUM>, filling sleeve <NUM>, piston spring <NUM>, and venting aperture <NUM>. Leaves of the petal-like shaped spring (needles protector <NUM>) bend over the filling needle <NUM> and the venting needle <NUM> protecting the user from inadvertent self-pricking. The spring leaves of the needles protector <NUM> are preloaded in the straight position (parallel to the filling needle <NUM>, venting needle <NUM> and vial adaptor <NUM>) and resume their preset bent shape (spring unloaded) after vial displacement.

<FIG> shows a transverse cross-section view of the assistance device <NUM> including a few components of the reservoir filling mechanism <NUM>, cannula insertion mechanism <NUM>, and the DP <NUM>. The reservoir filling mechanism <NUM> (dashed line) includes a plurality of, and preferably all of, the vial adaptor <NUM>, needles protector <NUM>, sliding rod <NUM>, filling needle <NUM>, venting needle <NUM>, filling piston <NUM>, interspace <NUM>, piston conduit <NUM>, transferring needle <NUM>, piston gasket <NUM>, interspace gasket <NUM>, transferring needle <NUM>, filling sleeve <NUM>, piston spring <NUM>, and venting aperture <NUM>. The cannula insertion mechanism <NUM> (dashed line) includes a plurality of, and preferably all of, trigger <NUM> and inserter spring <NUM> (other parts are not shown). The DP <NUM> includes a plurality of, and preferably all of, the filling port septum <NUM>, filling port well <NUM>, reservoir <NUM>, and reservoir plunger <NUM>. The vial adaptor <NUM>, the tip of the filling needle <NUM>, and the tip of the venting needle <NUM> are preferably arranged below the trigger <NUM> proving free access to the trigger <NUM>.

<FIG> shows a cross section of an assistance device <NUM> along the plane XX depicted in <FIG>. Assistance device <NUM> includes cannula insertion mechanism <NUM> and reservoir filling mechanism <NUM>. Reservoir filling mechanism <NUM>, according to some embodiments, includes vial adaptor <NUM>, plunger <NUM>, venting needle <NUM>, filling needle <NUM>, filling needle cap <NUM>, and cylinder <NUM>.

Filling needle <NUM> and venting needle <NUM> may run through the body of plunger <NUM>, with their ends protruding from the extremities of the plunger. The first end <NUM> of plunger <NUM> may be connected with vial adaptor <NUM>. The first end of venting needle <NUM> and the first end of filling needle <NUM> may both protrude from the first end <NUM> of plunger <NUM> into the interior of vial adaptor <NUM>. Various other features, according to various embodiments, may include the following functionality/ structure/clarification:.

Reference is made to <FIG>, which show a cross section of reservoir filling mechanism <NUM>, taken along the plane YY of <FIG>, in action, according to some embodiments. Reservoir filling mechanism <NUM> can be configured within assistance device <NUM> such that septum <NUM> of cylinder <NUM> is adjacent to or in contact with filling port septum <NUM> (<FIG>). The first step in filling reservoir <NUM> of pump disposable part <NUM> using reservoir filling mechanism <NUM>, according to some embodiments, is placing vial <NUM> in vial adaptor <NUM> such that the first tip of venting needle <NUM> and the first tip of filling needle <NUM> pierce the septum of vial <NUM> (<FIG>). Thus, following the placement of vial <NUM> in vial adaptor <NUM>, air from the interior of cylinder <NUM> may flow through venting needle <NUM> into the interior of vial <NUM>. Initially, the pressure within cylinder <NUM> may be the atmospheric pressure P. The pressures within the interior of filling port well <NUM>, filling conduit <NUM>, and the pressure exterior to reservoir plunger <NUM> may also be the atmospheric pressure P. The pressure in vial <NUM> may be greater than or equal to P. Vial <NUM> may initially include a volume of air (not shown) as well as insulin. End <NUM> of plunger <NUM> may initially be placed near the open end of cylinder <NUM>.

In the second step (<FIG>), the user pushes vial <NUM> downwards in the direction of the closed end of cylinder <NUM>, thereby pushing end <NUM> of plunger <NUM> towards the closed end of cylinder <NUM>. As a result, the volume of air trapped in the interior of cylinder <NUM> is reduced and the air within it is compressed. Air pressure within the interior of cylinder <NUM> increases to P+ > P. Because the interior of cylinder <NUM> is in fluid communication with the interior of vial <NUM>, the insulin in vial <NUM> becomes pressurized to P+ as well. Plunger <NUM> may advance in cylinder <NUM> to a position in which filling needle cap <NUM> comes into contact with cylinder septum <NUM>.

In the third step (<FIG>), the user continues to push vial <NUM> in the direction of the closed end of cylinder <NUM>. Filling needle <NUM> pierces through filling needle cap <NUM>, cylinder septum <NUM> and filling port septum <NUM>. As the second tip of filling needle <NUM> exits filling port septum <NUM> into filling well <NUM>, fluid communication is established between the interior of vial <NUM> and filling well <NUM>. Because the pressure P+ in vial <NUM> is greater than the atmospheric pressure P in filling well <NUM>, insulin begins to flow from vial <NUM> into well <NUM> and air begins to flow from the interior of cylinder <NUM> through venting needle <NUM> into vial <NUM> (<FIG>). Unidirectional valve <NUM> may prevent backflow of insulin or air from vial <NUM> to cylinder <NUM>. Pressure P+ is established in filling well <NUM> and filling conduit <NUM>. As a result, reservoir plunger <NUM> moves backwards and insulin enters reservoir <NUM> (<FIG>). Insulin continues to fill the reservoir until the pressure in vial <NUM> and well <NUM> equals the atmospheric pressure (<FIG>). The vial <NUM> is then removed from vial adaptor <NUM> and the filling process is complete.

<FIG> shows a cross section of an assistance device <NUM> along the plane XX depicted in <FIG>. Assistance device <NUM> includes cannula insertion mechanism <NUM> and reservoir filling mechanism <NUM>. Reservoir filling mechanism <NUM> includes vial adaptor <NUM>, plunger <NUM>, venting needle <NUM>, filling needle <NUM>, cylinder <NUM>, and conduit <NUM> which may optionally be equipped with unidirectional valve <NUM>. Filling needle <NUM> and venting needle <NUM> may protrude from the bottom end <NUM> of vial adaptor <NUM> and configured to puncture the septum of vial <NUM> and communicate with the interior of vial <NUM>. Venting needle <NUM> may be in fluid communication with conduit <NUM>, and conduit <NUM> may be in fluid communication with the interior of cylinder <NUM>. Valve <NUM> may enable the flow of air through conduit <NUM> from the interior of cylinder <NUM> to venting needle <NUM>, yet prevent the flow of air or insulin in the reverse direction. Filling needle <NUM> may initially be positioned across filling port septum <NUM>, thereby enabling fluid communication between the interior of vial <NUM> and filling well <NUM>. Plunger <NUM> may be configured to slidably fit within cylinder <NUM>. An airtight seal between plunger <NUM> and cylinder <NUM> may be established by means of a gasket <NUM>. Other functionality/features/clarifications may include:.

Reference is made to <FIG>, which show a cross section of reservoir filling mechanism <NUM>, taken along the plane YY of <FIG>, in action, according to some embodiments. Initially, plunger <NUM> is placed in cylinder <NUM> such that gasket <NUM> is near the opening <NUM> of the cylinder (<FIG>). The first step in filling reservoir <NUM> of pump disposable part <NUM> using reservoir filling mechanism <NUM> is, according to some embodiments, placing vial <NUM> in vial adaptor <NUM> such that the tip <NUM> of venting needle <NUM> and the first tip <NUM> of filling needle <NUM> pierce the septum of vial <NUM> (<FIG>). Thus, following the placement of vial <NUM> in vial adaptor <NUM>, air from the interior of cylinder <NUM> may flow through venting needle <NUM> into the interior of vial <NUM>. Initially, the pressure within cylinder <NUM> may be the atmospheric pressure P. The pressures within the interior of filling port well <NUM>, filling conduit <NUM>, and the pressure exterior to reservoir plunger <NUM> may also be the atmospheric pressure P. The pressure in vial <NUM> may be greater than or equal to P. Vial <NUM> may initially include a volume of air (not shown) as well as insulin.

In the second step (<FIG>), the user pushes plunger <NUM> downwards in the direction of the closed end of cylinder <NUM>. As a result, the volume of air trapped in the interior of cylinder <NUM> is reduced and the air within it is compressed. Air pressure within the interior of cylinder <NUM> increases to P+ > P. Because the interior of cylinder <NUM> is in fluid communication with the interior of vial <NUM>, the insulin in vial <NUM> becomes pressurized to P+ as well. Insulin flows from vial <NUM> to filling well <NUM> and filling conduit <NUM>, which thus become pressurized to P+. As a result of the pressure differential across reservoir plunger <NUM>, the reservoir plunger moves backwards in reservoir <NUM>, which thereby fills with insulin. Flow of insulin from vial <NUM> towards cylinder <NUM> is prevented by optional unidirectional valve <NUM>, which may be especially necessary if vial <NUM> is initially pressurized. The process continues until either the reservoir is completely filled with insulin (reservoir <NUM> may be equipped with stoppers preventing the exit of plunger <NUM> from the interior of the reservoir), until the end <NUM> of plunger <NUM> reaches the closed end <NUM> of cylinder <NUM> (<FIG>), or until the pressure in vial <NUM> equalizes the atmospheric pressure P. A sensor measuring the level of insulin in reservoir <NUM> may provide the user with an indication once the desired level of insulin in the reservoir is reached. The vial <NUM> is then removed from vial adaptor <NUM> and the filling process is complete (Fig. <NUM>).

<FIG> shows a cross section of an assistance device <NUM> along the plane XX depicted in <FIG>. Assistance device <NUM> is similar to assistance device <NUM>, except that it includes an automatic mechanism for depressing the plunger in the cylinder in lieu of manual depression as in device <NUM>.

Device <NUM> includes cannula insertion mechanism <NUM> and reservoir filling mechanism <NUM>. Reservoir filling mechanism <NUM> includes vial adaptor <NUM>, plunger <NUM>, venting needle <NUM>, filling needle <NUM>, cylinder <NUM>, and conduit <NUM> which may optionally be equipped with unidirectional valve <NUM>. Filling needle <NUM> and venting needle <NUM> may protrude from the bottom end <NUM> of vial adaptor <NUM> and be configured to puncture the septum of vial <NUM> and communicate with the interior of the vial. Venting needle <NUM> may be in fluid communication with conduit <NUM>, and conduit <NUM> may be in fluid communication with the interior of cylinder <NUM>. Valve <NUM> may enable the flow of air through conduit <NUM> from the interior of cylinder <NUM> to venting needle <NUM>, yet prevent the flow of air or insulin in the reverse direction. Filling needle <NUM> may initially be positioned across filling port septum <NUM>, thereby enabling fluid communication between the interior of vial <NUM> and filling well <NUM>. Plunger <NUM> may be configured to slidably fit within cylinder <NUM>. An airtight seal between plunger <NUM> and cylinder <NUM> may be established by means of a gasket <NUM>.

The filling and the venting needles may be made from a metal, such as stainless, or a plastic. The filling and the venting needles may be configured with sharp tips on both ends.

Vial adaptor <NUM> may be configured to reversibly receive vial <NUM>. Whenever vial <NUM> is placed in vial adaptor <NUM> the septum of the vial adaptor is pierced by the first end of venting needle <NUM> and the first end of needle <NUM>.

Filling mechanism <NUM> may include a driving mechanism <NUM>. The driving mechanism may comprise a power source <NUM>, a controller <NUM>, a motor <NUM>, and a gear <NUM>. The power source may be, for example, a single use battery or a rechargeable battery. The control unit may be a microcomputer, including a microprocessor and memory. The motor may be a direct current motor, such as a brush motor, a brushless motor, or a stepper motor. The power source may be the battery of the insulin pump residing in assistance device <NUM>, and the controller may be the pump's controller. The gear may be coupled to the plunger by means, for example, of a lead screw or a rack. Driving mechanism <NUM> may also include an input device such as an operating button.

In operation, filling mechanism <NUM> works mechanically in similar fashion to filling mechanism <NUM>. Therefore, a detailed description of the mechanics is omitted. However, in mechanism <NUM> the depression of plunger <NUM> in cylinder <NUM> is brought about by the action of driving mechanism <NUM>. Upon connection of vial <NUM> to vial adaptor <NUM>, the user may instruct driving mechanism <NUM> to depress plunger <NUM> in cylinder <NUM> through the input/output device. Alternatively, a sensor, such as an optical sensor, may detect the connection of the vial to the adaptor and then automatically instruct driving mechanism <NUM> to depress the plunger <NUM>. The instruction from the user or the sensor may be delivered to controller <NUM>, which may in turn provide voltage from power source <NUM> to motor <NUM>. Motor <NUM> may in turn cause plunger <NUM> to depress in cylinder <NUM> by means of gear <NUM>, thereby causing insulin to be delivered from vial <NUM> to filling well <NUM> and the pump reservoir as previously described for mechanism <NUM>.

<FIG> shows a cross section of an assistance device <NUM> along the plane XX depicted in <FIG>. Device <NUM> includes cannula insertion mechanism <NUM> and reservoir filling mechanism <NUM>. <FIG> shows a cross section of filling mechanism <NUM> along the plane ZZ depicted in <FIG>.

Reference is made to <FIG>. In some embodiments, reservoir filling mechanism <NUM> includes vial adaptor <NUM>, venting needle <NUM>, filling needle <NUM>, and conduit <NUM> which may optionally be equipped with unidirectional valve <NUM>. Filling needle <NUM> and venting needle <NUM> may protrude from the bottom end <NUM> of vial adaptor <NUM>, and be configured to puncture the septum of vial <NUM> and communicate with the interior of the vial. Venting needle <NUM> may be in fluid communication with conduit <NUM>, and conduit <NUM> may be in fluid communication with the atmosphere. Optional valve <NUM> may enable the flow of air through conduit <NUM> from the atmosphere to venting needle <NUM>, yet prevent the flow of air or insulin in the reverse direction. Filling needle <NUM> may initially be positioned across filling port septum <NUM>, thereby enabling fluid communication between the interior of vial <NUM> and filling well <NUM>.

Reference is made to <FIG>. In some embodiments, reservoir filling mechanism <NUM> may further include a driving mechanism <NUM>, and a coupling string. The driving mechanism may comprise a power source <NUM>, a controller <NUM>, a motor <NUM>, and a reel <NUM>. The power source may be, for example, a single use battery or a rechargeable battery. The control unit may be a microcomputer, including a microprocessor and memory. The motor may be a direct current motor, such as a brush motor, a brushless motor, or a stepper motor. The power source may be the battery of the insulin pump residing in assistance device <NUM>, and the controller may be the pump's controller. Driving mechanism <NUM> may also include an input device such as an operating button. The coupling string <NUM> may have a first end <NUM> connected to reel <NUM>, and a second end <NUM> connected to reservoir plunger <NUM>. String <NUM> may be configured with a nick <NUM> near its distal end <NUM>. Reservoir <NUM> may be configured with a stopper <NUM> disposed near its open end <NUM>. String <NUM> may be configured to transmit pulling force exerted by driving mechanism <NUM> sufficient to retract reservoir plunger <NUM>, yet break at nick <NUM> upon the reservoir plunger being pulled by the string against the stopper.

Reference is made to <FIG>, which depict a cross section of assistance device <NUM> taken along the ZZ plane of <FIG> in operation, according to some embodiments. In the first step of operation (<FIG>), vial adaptor <NUM> is empty and reservoir plunger <NUM> is at the reservoir end proximate filling conduit <NUM>. In the second step (<FIG>), the user inserts vial <NUM> into vial adaptor <NUM>. The first end of filling needle <NUM> pierces the septum of vial <NUM>, thereby enabling fluid communication between the interior of the vial and the atmosphere. The first end of filling needle <NUM> also pierces the septum of vial <NUM>. The second end of filling needle <NUM> traverses filling port septum <NUM>, thereby enabling fluid communication between the interior of vial <NUM>, filling port well <NUM> and filling port conduit <NUM>. In the third step (<FIG>), the user instructs the driving mechanism to fill the reservoir with insulin. The instruction may be given through the input device. Alternatively, a sensor in the vial adaptor, such as an optical or a mechanical sensor, may detect the presence of the vial <NUM> in the vial adaptor <NUM> and instruct the driving mechanism automatically to begin insulin filling. The instruction from the user or sensor may be delivered to controller <NUM>, which may subsequently supply voltage from power source <NUM> to motor <NUM>. The motor may cause reel <NUM> to rotate in the direction of the curved arrow (counterclockwise) thereby pulling coupling string <NUM> in the direction of the straight arrow (right). The string may therefore cause reservoir plunger <NUM> to move towards stopper <NUM>, thereby causing a negative pressure to form in the interior of vial <NUM>. Insulin will thus flow from the vial to reservoir. Air from the atmosphere may flow into vial <NUM> through venting needle <NUM> and, optionally through valve <NUM>, thereby replacing in the vial the insulin supplied to the reservoir. This process may continue until reservoir plunger <NUM> reaches stopper <NUM>, which marks the end of reservoir filling (<FIG>). Driving mechanism will continue to pull string <NUM> against stopper <NUM> until string <NUM> breaks at nick <NUM> (<FIG>). At this point, driving mechanism <NUM> will cease to rotate reel <NUM>, by, for example, means of an instruction from a motor current sensor, or by means of a motor revolution counter. Vial <NUM> may be removed (<FIG>) from vial adaptor <NUM>, which completes the filling process.

<FIG> shows a cross section of an assistance device <NUM> along the plane XX depicted in <FIG>, according to some embodiments. Assistance device <NUM> includes cannula insertion mechanism <NUM> and reservoir filling mechanism <NUM>. Reservoir filling mechanism <NUM> is similar to reservoir filling mechanism <NUM> of device <NUM>, except that the cylinder <NUM> and the plunger <NUM> of mechanism <NUM> are replaced with a bellow <NUM> in filling mechanism <NUM>.

Reservoir filling mechanism <NUM> includes vial adaptor <NUM>, shaft <NUM>, venting needle <NUM>, filling needle <NUM>, filling needle cap <NUM>, and collapsible bellow <NUM>. Filling needle <NUM> and venting needle <NUM> may run through the body of shaft <NUM>, with their ends protruding from the extremities of the shaft. The first end <NUM> of shaft <NUM> may be connected with vial adaptor <NUM>. The first of venting needle <NUM> and the first end of filling needle <NUM> may both protrude from the first end <NUM> of plunger <NUM> into the interior of vial adaptor <NUM>.

The second end of shaft <NUM> may be connected to the first end <NUM> of bellow <NUM>. The second end <NUM> of bellow <NUM> may be configured with a bellow septum <NUM>. The connection of the bellow to the shaft may be airtight.

The filling and the venting needles may be made from a metal, such as steel, or a plastic. The filling and the venting needles may be configured with sharp tips on both ends.

Vial adaptor <NUM> may be configured to reversibly receive vial <NUM>. Whenever vial <NUM> is placed in vial adaptor <NUM> the septum of the vial adaptor can be pierced by the first end of venting needle <NUM> and the first end of needle <NUM>.

Venting needle <NUM> may optionally be configured with a unidirectional valve <NUM> allowing air to flow from the interior of cylinder <NUM> to the interior of vial <NUM>, yet preventing air or fluid flow from the interior of the vial to the interior of the bellow.

The second end of filling needle <NUM> may be provided with a filling needle cap <NUM>. Filling needle cap <NUM> may be made from plastic. Filling needle cap <NUM> may be configured to seal the second tip of filling needle <NUM>.

The operation of filling mechanism <NUM> is similar to that of filling mechanism <NUM>. Therefore, its detailed description is omitted. Briefly, the first step is to connect vial <NUM> to vial adaptor <NUM>. Fluid communication is established between the interior of bellow <NUM> and the interior of vial <NUM>. Next, the user pushes the vial down, thereby compressing the air trapped in the bellow. The increased pressure is transmitted to the interior of the vial. This continues until filling needle cap <NUM> touches bellow septum <NUM>. The user then continues to push the bottle down, thereby causing filling needle <NUM> to pierce the cap, the bellow septum and the filling port septum <NUM>. Fluid communication is established between the interior of the vial and filling port well <NUM>. The increased pressure in the vial causes insulin to flow from the vial to the filling port well. The increased pressure in the filling port causes the reservoir plunger to retract, thereby filling the reservoir with insulin. Once the reservoir is filled, the vial is disconnected from the vial adaptor and the filling process is complete.

Reference is made to <FIG>, which shows various schematic drawings of an insulin pump <NUM> in accordance with an embodiment of the invention. <FIG> A shows a schematic top view of pump <NUM>. <FIG> shows a schematic cross section taken along the plane YY. <FIG> C shows a schematic cross section taken along the plane ZZ, and <FIG> D shows a schematic cross section taken along the plane XX.

Pump <NUM> is very similar to pump <NUM> described above, except that disposable part <NUM> is replaced with disposable part <NUM>. Disposable part <NUM> is very similar to disposable part <NUM>, except that (<NUM>) exit port septum <NUM> is replaced with top exit port septum <NUM> configured within a cup hole <NUM>, which is integral with disposable part <NUM>, (<NUM>) exit port well <NUM> is replaced with exit port well <NUM> and (<NUM>) bottom exit port septum <NUM> is added (<FIG> C and D).

Reference is made to <FIG>, which shows a schematic drawing of an assistance device <NUM> including pump <NUM> assembled therein, according to an embodiment of the invention. Assistance device <NUM> includes the reservoir filling mechanism <NUM> described above, as well as a soft cannula insertion mechanism <NUM>. Soft cannula insertion mechanism <NUM> includes trigger <NUM>, inserter spring <NUM>, inserter hammer <NUM>, steel cannula <NUM> (which may also be referred to as a rigid cannula), soft cannula <NUM>, cup <NUM>, and cup septum <NUM>. Cup <NUM> is configured to ultimately fit snugly (i.e., securely) within cup hole <NUM>.

Steel cannula <NUM> may be made from metal, such as steel or, for example, from a hard plastic. Soft cannula <NUM> may be made from a soft plastic, such as, for example, Teflon. Steel cannula <NUM> may be configured with a steel cannula side hole <NUM> and soft cannula <NUM> may be configured with a soft cannula side hole <NUM>. Initially, steel cannula <NUM> may be arranged in the lumen of soft cannula <NUM> such that side holes <NUM> and <NUM> coincide.

The top end of steel cannula <NUM> may be rigidly connected to inserter hammer <NUM>. The top end of soft cannula <NUM> may include a stopper <NUM>, configured to prevent soft cannula <NUM> from sliding out of the bottom end of cup <NUM>. The stopper may be integral with the cannula. Cup septum <NUM> may seal the interior of cup <NUM>. Steel needle <NUM> may initially traverse cup septum <NUM>. Initially, the sharp bottom end of steel cannula <NUM> may protrude beyond the bottom end of soft cannula <NUM>. Both ends may initially reside in exit port well <NUM>. Initially, both steel cannula <NUM> and soft cannula <NUM> may traverse top exit port septum <NUM>. Initially, inserter spring <NUM> may be cocked, that is, placed in a condition under which the inserter spring includes potential energy. Cannula bending spring <NUM> may also be cocked (i.e., placed in a condition under which the bending spring includes potential energy), prevented from bending towards the cannulas by the side of pump <NUM>.

Reference is made to <FIG>. According to some embodiments, in operation, assistance device <NUM> may be used as previously described to assemble pump <NUM> from the reusable and disposable parts. Reservoir filling mechanism <NUM> may be used to fill the reservoir with insulin. Once the reservoir is full, doser <NUM> may be operated to prime the pump by pumping fluid through exit port conduit <NUM> into filling port well <NUM>, and from there through the lumen of steel cannula <NUM> and out of side holes <NUM> and <NUM> (<FIG>). The priming process may continue until air exits the doser and reservoir and insulin drips out of side hole/opening <NUM>. Note that the top end of steel cannula <NUM> may be sealed and that the top end of soft cannula <NUM> may create a seal with steel cannula <NUM>, and therefore the only way for insulin to flow out of exit port well <NUM> during priming is through the side holes <NUM> and <NUM>.

Once priming is complete, the user may peel the liner from the adhesive base (not shown) and reversibly place pump <NUM> on the body using assistance device <NUM>. The user may then use soft cannula insertion mechanism <NUM> to place the bottom tip of soft cannula <NUM> under the skin. This may be done in the following way (<FIG>): First, the user may press trigger <NUM> and the safety catches (no shown) to release the energy stored in cocked inserter spring <NUM> and drive inserter hammer <NUM> in the bottom direction. Thus, cup <NUM>, cup septum <NUM>, steel cannula <NUM> and soft cannula <NUM> may move towards the patient's skin. The sharp tip of steel cannula <NUM> may puncture the skin and subcutaneous tissue, making a path to follow for soft cannula <NUM>. The insertion process may end (<FIG>) when the bottom of cup <NUM> resides on the top of top septum <NUM>, with cup <NUM> placed in cup hole <NUM>, and side holes <NUM> and <NUM> are in fluid communication with exit port well <NUM>. The bottom ends of steel cannula <NUM> and soft cannula <NUM> are under the patient's skin.

Next, the user may remove assistance device <NUM> (<FIG>), thereby also removing steel cannula <NUM> from the lumen of soft cannula <NUM>. The elastic energy stored in cannula bending spring <NUM> may be released upon separation of the assistance device and the pump. The spring may bend in the direction of steel cannula <NUM>, thereby bending the steel cannula into the interior of the assistance device. Sharp injury by the steel cannula is thus prevented. Pump <NUM> remains adhered to the patient's body, with soft cannula <NUM> inserted transcutaneously with its bottom end under the patient's skin, and with side hole <NUM> in fluid communication with exit port well <NUM>. The user and doser <NUM> are in fluid communication via exit port conduit <NUM> (<FIG>), exit port well <NUM>, soft cannula side hole <NUM> and the patient's subcutaneous tissue. As cup septum <NUM> is sealed once steel cannula <NUM> is removed, the only place insulin can flow from doser <NUM> is to the user. The pump is ready to deliver insulin to the user.

Note that any combination of a reservoir filling mechanism <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, or <NUM> may be used in combination with either cannula insertion mechanism <NUM> or soft cannula insertion mechanism <NUM> to produce an assistance device.

Reference is made to <FIG>, which shows a closed loop insulin delivery system, (or artificial pancreas) <NUM>, according to some embodiments. Closed loop system <NUM> can include a pump <NUM>, a controller <NUM>, a charger <NUM>, and an assistance device <NUM>. Pump <NUM> includes a reusable motor unit <NUM> and a disposable cannula unit <NUM> that are reversibly attachable.

Motor unit <NUM>, according to some embodiments, is substantially similar to motor unit <NUM> described previously. Accordingly, it may include an electronics module, a driving mechanism and a battery (all not shown). The electronics module may comprise a microprocessor, memory, and communications, such as low energy blue tooth radio (BLE). The memory may include software comprising a closed loop algorithm that calculates the instantaneous insulin infusion rate as a function of inputs including, for example, past and present glucose levels sensed by a continuous glucose sensor. Motor unit <NUM> (<FIG>) may include electrical contacts <NUM> electrically connected to the electronics module. Electrical contacts <NUM> may include one or more contacts. Electrical contacts <NUM> may include four contacts, with two contacts <NUM> configured to supply power from the motor unit and two contacts <NUM> configured to transmit data. Data may be transmitted in analog or digital form.

Cannula unit <NUM> (<FIG>), according to some embodiments, is substantially similar to cannula unit <NUM> described previously. Cannula unit <NUM> may include a reservoir <NUM>, a doser <NUM>, and an adhesive base <NUM>, similar to the corresponding parts of cannula unit <NUM>. The main difference is that cannula unit <NUM> may include a channel <NUM> traversing it from top to bottom. Channel <NUM> is configured to receive a continuous glucose sensor and to assist in establishing electrical contact between contacts <NUM> on motor unit <NUM> and the continuous glucose sensor.

Controller <NUM>, according to some embodiments, is substantially similar to controller <NUM> of system <NUM>, except that it may include in addition software to support the closed loop algorithm of system <NUM>. The charger of system <NUM> is similar to the charger <NUM> of system <NUM>.

Assistance device <NUM>, according to some embodiments, is similar to assistance device <NUM>, except that it includes a modified inserter module capable of storing a continuous glucose sensor and inserting it under the patient's skin.

Reference is made to <FIG> shows a schematic top view of pump <NUM> when deployed in a user, according to some embodiments. The plane where motor unit <NUM> interfaces with cannula unit <NUM> is denoted WW, and the plane parallel to WW and intersecting filling port septum <NUM> and exit port septum <NUM> is denoted XX as before. A continuous glucose sensor <NUM> is placed in channel <NUM>. <FIG> shows a cross section of Pump <NUM> along plane WW, with continuous glucose sensor <NUM> placed in channel <NUM>, with the pointed end of sensor <NUM> protruding beyond the skin-facing plane of the pump <NUM>. <FIG> shows a cross section a cross section of pump <NUM> along plane XX, with the sharp end of cannula <NUM> protruding from the skin-facing plane of pump <NUM>.

Reference is made to <FIG> which shows a front view of continuous glucose sensor <NUM> according to some embodiments. Sensor <NUM> comprises a head <NUM> a prong <NUM>, both of which may include a basis made from an insulator such as a biocompatible plastic or a ceramic. Electrical contacts <NUM> may be placed on the head by, for example, printing. Electrical contacts <NUM> may include one or more contacts configured to interface with contacts <NUM> on motor unit <NUM>. Electrical contacts <NUM> may include four contacts, including a pair of contacts for transmitting power from the motor unit, and a pair of contacts <NUM> for transmitting analog or digital data. Sensor <NUM> may include a front-end chip <NUM>, possibly including an analog-to-digital converter, working electrode <NUM>, and a counter-electrode <NUM> on its back side (<FIG>). Sensor <NUM> may optionally include a reference electrode (not shown). Whenever a reference electrode is used, additional contacts <NUM> and <NUM> may include five or more contacts.

Working electrode <NUM> (<FIG>) may include a conductor <NUM> made from a metal such as platinum, an enzyme <NUM>, such as glucose oxidase, configured to generate an electrical current proportional to the ambient glucose concentration, and a selective membrane <NUM>, such as PTFE, configured to prevent interference from non-glucose electrochemically active agents. The various layers of the working electrode may be printed. Counter electrode <NUM> may be made, for example, from silver or silver chloride. Working electrode <NUM> may be electrically connected to front end chip <NUM> by a conductor <NUM>. Counter-electrode <NUM> may be connected to front-end chip <NUM> by a conductor <NUM>, configured to traverse prong <NUM> from the front to the back through a hole in the prong.

Working electrode <NUM> may comprise a metal catalyst in lieu of the enzyme. Selective membrane <NUM> may be optional.

Electrical contacts <NUM> may be covered by a tape <NUM>, which may be adhesive on both sides. Tape <NUM> may have high electrical conductivity in the Z directions and very low electrical conductivity in the X and Y directions. For example, tape <NUM> may be a Z-Axis Conductive Tape made by <NUM>. Optionally, tape <NUM> may be surrounded by a ring or frame of double sided adhesive, which may create a water proof seal around contacts <NUM> and <NUM> when pressed between the two plane surfaces sandwiching them (not shown). Contacts <NUM> may be electrically connected to front-end chip <NUM> by power-supplying conductors <NUM>, and data may be transmitted to and from chip <NUM> by data conductors <NUM>.

The head of sensor <NUM> may be covered by a liner <NUM> (<FIG>), according to some embodiments. Liner <NUM> may be made out of, for example, a thin layer of plastic, a thin layer of paper, or paper coated by a plastic layer. Liner <NUM> may include a motor unit facing part (MU facing part) <NUM> and a cannula-unit facing part (CU facing part) <NUM>. The CU facing part <NUM> may be folded over itself and connected to the back side of head <NUM> using an adhesive layer. The MU facing part <NUM> may also be folded over itself and connected to the front of the head using tape <NUM>. Proximal end <NUM> may be connected to hammer <NUM> of assistance device <NUM>'s insertion mechanism <NUM> (<FIG>).

Reference is made to <FIG> and <FIG>, which schematically show an assistance device <NUM> according to some embodiments. Assistance device <NUM>, according to some embodiments, is similar to, for example, assistance device <NUM>. It includes a filling mechanism <NUM>, and an insertion mechanism <NUM> configured to insert subcutaneously both cannula <NUM> and continuous glucose sensor <NUM>. <FIG> shows a schematic cross section of assistance device <NUM> taken along the XX plane depicted in <FIG>, and <FIG> shows a schematic cross section of assistance device <NUM> taken along the WW plane depicted in <FIG>. The main differences between assistance device <NUM> and assistance device <NUM> are that device <NUM> initially includes pump <NUM> instead of pump <NUM>, insertion mechanism <NUM> includes sensor <NUM>, and inserter hammer <NUM> is replaced with inserter hammer <NUM>. Inserter hammer <NUM> is configured to simultaneously deploy both cannula <NUM> and sensor <NUM> through the pump (the latter via channel <NUM>) and traverse the user's skin. Alternatively, two separate hammers may be used in insertion mechanism <NUM> to insert the cannula and the sensor.

The operation of system <NUM>, according to some embodiments, is similar to the operation of system <NUM> described above. Motor unit <NUM> may be inserted into a slot in assistance device <NUM>, thereby assembling pump <NUM> from motor unit <NUM> and cannula unit <NUM>. Pump <NUM> may be filled with insulin using insulin filling mechanism <NUM> as described above. The pump may then be primed using a command from controller <NUM>. The adhesive on the skin-facing side of pump <NUM> may be exposed by peeling a liner (not shown). Assistance device <NUM> may then be used to place pump <NUM> on the user's skin at a desired location. Once the pump is adhered to the skin, trigger <NUM> may be pressed to shoot the cannula and the sensor by means of releasing the elastic energy stored in spring <NUM>. The force generated by the spring may be transmitted to the cannula <NUM> and the sensor <NUM> by hammer <NUM>.

The sharp tip of prong <NUM> may penetrate the user's skin. Alternatively, a guiding needle (not shown) may be used to penetrate the skin and lead the way for prong <NUM>.

<FIG> shows sensor <NUM> immediately after it has been driven through channel <NUM> by hammer <NUM>, according to some embodiments. The CU facing fold <NUM> of liner <NUM> is positioned between cannula unit <NUM> and the back side of sensor head <NUM>. MU facing fold <NUM> of liner <NUM> is positioned between the front side of sensor head <NUM> and motor unit <NUM>. Contacts <NUM> on the motor unit are aligned with the corresponding contacts <NUM> on the sensor head.

To finalize the connection of artificial pancreas <NUM> to the user, in some embodiments, assistance device <NUM> may be pulled away from the patient's skin (<FIG>). This causes MU facing fold <NUM> of liner <NUM> to peel from tape <NUM>, thereby exposing the tape. This also causes CU-facing fold <NUM> to push sensor head <NUM> towards motor unit <NUM>, thereby electrically connecting sensor <NUM> and motor unit <NUM> by means the tape's high conductance in the Z direction. The low conductance in the X and Y directions ensures that the cross-talk between non-corresponding contacts is sufficiently low. Moreover, the system is made less sensitive to cross talk because the signal transferred through contacts <NUM> and <NUM> is digitized by front end chip <NUM>, and not transmitted in the more error prone analog form. Tape <NUM> may cover contacts <NUM> on its one side and contacts <NUM> on its other side to seal them in waterproof fashion.

<FIG> shows the sensor in its subcutaneously inserted configuration, electrically connected to pump <NUM> via the motor unit, according to some embodiments. Artificial pancreas <NUM> is thus prepared for operation.

While various inventive embodiments have been described and illustrated herein, those of ordinary skill in the art will readily envision a variety of other means and/or structures for performing the functionality disclosed herein and/or obtaining the results and/or one or more of the advantages described - each of such variations and/or modifications is deemed to be within the scope of the inventive embodiments described herein. More generally, those skilled in the art will readily appreciate that all parameters, dimensions, materials, and configurations described herein are meant to be an example and that the actual parameters, dimensions, materials, and/or configurations will depend upon the specific application or applications for which the inventive teachings is/are used. Those skilled in the art will recognize, or be able to ascertain using no more than routine experimentation, many equivalents to the specific inventive embodiments described herein. It is, therefore, to be understood that the foregoing embodiments are presented by way of example only and that, within the scope of the appended claims and equivalents thereto; inventive embodiments may be practiced otherwise than as specifically described and claimed. Inventive embodiments of the present disclosure are directed to each individual feature, function, system, article, material, kit, and/or method/step described herein. In addition, any combination of two or more such features, functions, systems, articles, materials, kits, and/or methods/steps, if such features, functions, systems, articles, materials, kits, and/or methods/steps are not mutually inconsistent, is included within the inventive scope of the present disclosure. Some embodiments may be distinguishable from the prior art for specifically lacking one or more features/elements/functionality (i.e., claims directed to such embodiments may include one or more negative limitations).

In addition, and as noted, with respect to the various inventive concepts embodied as one or more methods, the acts performed as part of the method may be ordered in any suitable way. Accordingly, embodiments may be constructed in which acts are performed in an order different than illustrated, which may include performing some acts simultaneously, even though shown as sequential acts in illustrative embodiments.

All definitions, as defined and used herein, should be understood to control over dictionary definitions, definitions in referenced documents, and/or ordinary meanings of the defined terms.

Claim 1:
A patch pump assisting system comprising:
a disposable device (<NUM>); and
an assisting device (<NUM>) including a soft cannula insertion mechanism (<NUM>) configured to at least insert a soft cannula (<NUM>) in tissue,
wherein the disposable device (<NUM>) includes:
a housing;
an first exit port septum (<NUM>) configured within a cup opening (<NUM>);
an exit port well (<NUM>); and
an second exit port septum (<NUM>);
and
a soft cannula (<NUM>) having a lumen, and a rigid cannula (<NUM>) having a lumen, and wherein:
the soft cannula (<NUM>) and rigid cannula (<NUM>) each include at least one lateral opening (<NUM>, <NUM>) along a length thereof and a tip;
the housing is configured for placement on the skin of a user for cannula insertion and remains after insertion;
prior to insertion, the rigid cannula (<NUM>) is positioned within the soft cannula (<NUM>) with a portion of both cannulas (<NUM>, <NUM>) initially traversing the first exit port septum (<NUM>) and the tip of the rigid cannula (<NUM>) is positioned within the exit port well (<NUM>);
after insertion, the lateral openings (<NUM>) of the soft cannula (<NUM>) are positioned within the well (<NUM>) and the tip of the soft cannula (<NUM>) is positioned within the body.