Drug delivery detection system

Abstract

In one embodiment, a drug delivery system 100B is presented. The drug delivery system has a housing 150. The housing has a drug delivery device and an injection system 180. The injection system has a set of rails 104A, 104B and 104C. The drug delivery system has a first sliding member 116 that is operable to move on the set of rails and a second sliding member 124 that is operable to move on the set of rails. The drug delivery system has a positioning element 108 configured to move the first sliding member, which is guided by the set of rails, in a first direction and move the second sliding member, which is guided by the set of rails, in a second direction.

Description

Technical Field

[0001] Cross - Reference to Related Applications This application claims the priority and benefit of U.S. Provisional Application No. 63 / 501,908, filed May 12, 2023, which is hereby incorporated herein by reference in its entirety.

[0002] The presently disclosed subject matter generally relates to drug delivery devices. In particular, the presently disclosed subject matter relates to drug delivery and analyte sensing systems and insertion mechanisms therefor.

Background Art

[0003] Modern drug delivery devices typically have a reservoir containing a liquid drug, a pump mechanism, and an insertion mechanism for introducing a needle or cannula into the subcutaneous region of the user's skin to deliver the liquid drug to the user. The user can also use a separate sensing device, such as a glucose sensor, which measures changes in the user's blood chemistry through a sensing element across the user's subcutaneous region to detect various user physiological properties. These drug delivery devices and sensing devices are located separately due to both the potential for interference in the delivery of the liquid drug and the problems with the sensing element caused by puncture wounds to the user's skin from the delivery element, as well as interference by the liquid drug on the sensing element. It would be advantageous if the drug delivery device were in the same location as the sensing device.

Prior Art Documents

Patent Documents

[0004]

Patent Document 1

Patent Document 2

Patent Document 3

Patent Document 4

[0005] The present invention relates to a drug delivery system comprising a housing. The housing comprises a drug delivery device and an injection system. The injection system comprises a set of rails. The drug delivery system comprises a first sliding member operable to move along the set of rails and a second sliding member operable to move along the set of rails. The drug delivery system comprises a positioning element configured to move the first sliding member in a first direction guided by the set of rails and the second sliding member in a second direction guided by the set of rails.

[0006] The present invention also relates to a drug delivery device having a drug delivery device and a set of rails. There are gaps between the individual rails of the set of rails. The drug delivery device has an injector positioned adjacent to the gaps of the set of rails and positioned to mirror a sensing element. The drug delivery device has a biasing mechanism connected to a first sliding member. The first sliding member is operable to move a cannula in a first direction along the set of rails and to move a sensing element in a second direction opposite to the first direction along the set of rails. The drug delivery device has an insertion funnel positioned on the opposite side from the set of rails, and the insertion funnel has an insertion funnel inlet configured to allow the sensing element to pass into the insertion funnel.

[0007] In embodiments not claimed, a drug delivery system having a housing is envisioned. The housing has a drug delivery device. The drug delivery device has a pump. The drug delivery device has an injection system connected to the pump. The injection system has a first set of rails and a second set of rails. The drug delivery system has a first sliding member operable to move on the first set of rails, the first sliding member having a sensor. The drug delivery system has a second sliding member operable to move on a second set of rails, the second sliding member having a cannula connected to the pump. The drug delivery device has a positioning element configured to move the first sliding member in a first direction guided by the first set of rails and the second sliding member in a second direction guided by the second set of rails.

[0008] A preferred embodiment forms the subject matter of a dependent claim.

[0009] These and other aspects and features of the currently disclosed, non-limiting embodiments of the subject will become apparent to those skilled in the art upon closer examination of the following descriptions of specific, non-limiting embodiments of the subject disclosed in conjunction with the accompanying drawings. [Brief explanation of the drawing]

[0010] [Figure 1A] Figure 1A shows a block diagram of one embodiment of a wearable drug delivery and detection system. [Figure 1B] Figure 1B shows an exemplary embodiment of the insertion system. [Figure 1C] Figure 1C shows an exemplary embodiment of the insertion system. [Figure 1D] Figure 1D shows an exemplary embodiment of the insertion system. [Figure 2A] Figure 2A shows an insertion system of another exemplary embodiment. [Figure 2B] Figure 2B shows an insertion system of another exemplary embodiment. [Figure 2C]Figure 2C shows an insertion system of another exemplary embodiment. [Figure 2D] Figure 2D shows an insertion system of another exemplary embodiment. [Figure 2E] Figure 2E shows an insertion system of another exemplary embodiment. [Figure 2F] Figure 2F shows an insertion system of another exemplary embodiment. [Figure 2G] Figure 2G shows an insertion system of yet another exemplary embodiment. [Figure 2H] Figure 2H shows an insertion system of yet another exemplary embodiment. [Figure 2I] Figure 2I shows an insertion system of yet another exemplary embodiment. [Figure 3A] Figure 3A shows an insertion system of yet another exemplary embodiment. [Figure 3B] Figure 3B shows an insertion system of yet another exemplary embodiment. [Figure 3C] Figure 3C shows an insertion system of yet another exemplary embodiment. [Figure 4A] Figure 4A shows an insertion system of a further exemplary embodiment. [Figure 4B] Figure 4B shows an insertion system of a further exemplary embodiment. [Figure 4C] Figure 4C shows an insertion system of a further exemplary embodiment. [Figure 4D] Figure 4D shows an insertion system of a further exemplary embodiment. [Figure 4E] Figure 4E shows an insertion system of a further exemplary embodiment. [Figure 4F] Figure 4F shows an insertion system of a further exemplary embodiment. [Figure 4G] Figure 4G shows an insertion system of a further exemplary embodiment. [Figure 4H] Figure 4H shows an insertion system of a further exemplary embodiment. [Figure 4I] Figure 4I shows an insertion system of a further exemplary embodiment. [Figure 5] Figure 5 shows an exemplary embodiment of a wearable drug delivery and detection system. [Modes for carrying out the invention]

[0011] The following description includes numerous specific details for illustrative purposes to provide a complete understanding of the subject matter currently disclosed. However, it is clear that the subject matter currently disclosed can be implemented without these specific details. As used herein, the terms “exemplary” or “illustrative” mean “serving as an example, instance, or illustration.” Any implementation described herein as “exemplary” or “illustrative” should not necessarily be construed as being preferable or advantageous to other implementations. All embodiments described below are exemplary embodiments provided to enable a person skilled in the art to make or use embodiments of the disclosure and are not intended to limit the scope of the disclosure as defined by the claims.

[0012] At a high level, aspects of this disclosure relate to drug delivery and detection devices, as well as systems of drug delivery and detection devices. A drug delivery detection system may have a mechanism that allows for the insertion of a sensing element of a sensor into a first location within the user's epidermis and the insertion of a needle and / or cannula for liquid drug delivery into a second location within the user's epidermis, both of which may be triggered automatically or manually. There may be some risk in positioning if the cannula is placed too close to the sensor (e.g., less than 1 inch or less than 25.4 millimeters (mm)), such as interference with the sensor by delivery of liquid or further fluids produced by the body to repair wounds caused by puncturing the epidermis. Furthermore, damage to the epidermis from puncture wounds from the introducer (needle / trocar) may lead to an increased warm-up time for the sensor. Several embodiments described herein are factors in distance metrics and provide both introducer options and sensor insertion options without an introducer. Embodiments of this disclosure may be used to provide a detection device that is positioned in the same location as a drug delivery device in a wearable drug delivery and detection system.

[0013] Figure 1A shows a block diagram of one embodiment of a wearable drug delivery and detection system (100). The wearable drug delivery and detection system 100 may have a housing 150 that houses a drug delivery device 160, a sensor 170, and an insertion system 180. The housing 150 may have multiple parts and / or housings that fit together to provide an outwardly single device that can be attached to the user's skin. For example, the housing 150 may have a first housing portion that houses one or more of the components described herein and can be attached to the user's skin with adhesive, and a second housing portion that houses one or more of the components described herein and can be attached to the user's skin with adhesive. In addition to or instead of this, the first housing portion and the second housing portion may fit together into a tray or cradle that is adhesively attached to the user's skin. The housing 150 may have housing exits, such as reference numbers 158 and 159, which are configured and sized to allow the sensing device or element (described later) of the sensor 170 and the needle / cannula (described later) to exit the housing 150 and penetrate the user's skin. The drug delivery device 160 may have a controller 164, a pump mechanism 166, and a reservoir 168. The controller 164 may be operable to transmit and / or receive signals to the sensor 170, the insertion system 180, and / or the pump mechanism 166, or other elements, as described with reference to Figure 5. For example, the controller 164 may be operable to deliver a liquid drug from the reservoir 168 via the pump mechanism 166 and the fluid pathway generated by the insertion system 180, based on measurements provided by the sensor 170. Furthermore, the controller 164 may be operable to activate or operate the insertion system 180, as described with reference to the following examples.Reservoir 168 may be operable to contain any liquid drug in liquid form that can be administered by a drug delivery device via a subcutaneous cannula, or a liquid drug containing such drugs, for example, insulin, glucagon-like peptide-1 (GLP-1), glucose-dependent insulinotropic polypeptide (GIP), pramulintide, glucagon, co-formulations of two or more GLP-1s, GIPs, pramulintide, and insulin, as well as analgesics such as opioids or narcotics (e.g., morphine), methadone, antihypertensive drugs, chemotherapeutic drugs, and fertility drugs.

[0014] The housing 150 may also have an opening for a mechanical actuator 190 (e.g., a button, a sliding mechanism, a dial, etc.) connected to the insertion system 180. The mechanical actuator 190 may be configured to receive input from outside the housing 150 (e.g., from the user's fingertips or hands), and in response to this input, the insertion system 180 may be operated as described in relation to the following embodiments. Alternatively, the operation of the insertion system 180 may be automated or triggered by wireless communication from a separate controller, as described elsewhere in this specification.

[0015] Examples of drug delivery devices are disclosed, for example, in Patent Document 1 (U.S. Patent No. 7,128,727), Patent Document 2 (U.S. Patent No. 7,018,360), Patent Document 3 (U.S. Patent No. 7,144,384), Patent Document 4 (U.S. Patent No. 10,420,883), Patent Document 5 (U.S. Patent Application Publication No. 2007 / 0118405), Patent Document 6 (U.S. Patent Application Publication No. 2006 / 0282290), Patent Document 7 (U.S. Patent Application Publication No. 2005 / 0238507), and Patent Document 8 (U.S. Patent Application Publication No. 2004 / 0010207).

[0016] In some embodiments, aspects of the present disclosure are applicable to existing drug delivery device mechanisms to reduce manufacturing costs or the number of elements or mechanisms required for the insertion of drug delivery and detection elements. An insulin pump co-located with a glucose detection device has long been a goal of the diabetes industry. Combining and packaging these two technologies together via an insertion system is beneficial and advantageous from the standpoint of user experience, and allows for the integration of the sensor and drug delivery device within a single device or in a single location.

[0017] Figure 1B shows an insertion system (187) usable in an exemplary drug delivery and detection system 100 of an exemplary embodiment shown in Figure 1A. In Figure 1B, the drug delivery system is indicated by reference numeral 100B. The insertion system 187 in Figure 1B is shown in its initial or pre-deployment position. In this embodiment, the insertion system 187 in Figure 1B may have several rails, such as rails 104A, 104B, and 104C. As used in this disclosure, “rail” is one or more structural elements that guide one or more objects in one direction. The rails 104A, 104B, and 104C may have one or more materials, for example, plastic, metal, etc., but are not limited to the following. The rails 104A to 104C may be oriented horizontally, vertically, and / or in combination thereof, without limitation. Between rails 104A, 104B, and 104C, there may be gaps that allow one or more elements to pass between rails 104A-104C and / or along the rails. The first rail 104A may be adjacent to the first horizontal gap 105A on its first side, and the second rail 104B may be adjacent to the first horizontal gap 105A on its second side. The first rail 104A and the second rail 104B may form a first pair of rails. The second rail 104B may be adjacent to the second horizontal gap 105B located between the second rail 104B and the third rail 104C. The second rail 104B and the third rail 104C may form a second pair of rails.

[0018] The insertion system 187 may have a sensing device or element 112. The “sensing device” or “sensing element” used in this disclosure is a device capable of detecting a sample in blood or fluid within the interstitial tissue of the user. The sensing element 112 may have a blood glucose sensor such as a continuous glucose monitor (CGM), ketone sensor, or blood oxygen sensor. In one embodiment, the sensing element 112 may be configured to detect one or more blood glucose levels of the user and communicate data indicating one or more blood glucose levels or glucose levels to a computing device such as the controller 164 in Figure 1A.

[0019] The sensing element 112 may be guided by a rail 104 having an insertion end 114 of the sensing element 112 that extends beyond the biasing mechanism 142 on one side, and a driven end 115 that extends beyond rails 104B and 104C on the opposite side. Naturally, the orientation can be reversed. As used in this disclosure, “insertion end” is a part of an object that is inserted into the user. The insertion end 114 of the sensing element 112 may have a needle, cannula, trocar, and / or other piercing element. In some embodiments, the needle, cannula, or trocar of the sensing element 112 may be hollow, and the sensing element 112 may be inside the needle, cannula, or trocar. For example, but not limited to, the sensing element 112 may have an insertion end having a piercing element on the end of a hollow tube, and a head end having a sensor or other device connected to the hollow tube on the opposite side of the piercing element. The insertion end 114 can exit the housing 150 at the housing exit 119.

[0020] The insertion system 180 may have a needle / cannula 136. The needle / cannula 136 may be configured to provide a fluid path from the reservoir to the user for the delivery of a liquid drug from the reservoir of the drug delivery device. The needle / cannula 136 may have an insertion end 137 on the side of the rails 104B and 104C (e.g., the right side in Figure 1B). In some embodiments, the needle / cannula 136 may be configured to move linearly or curvilinearly relative to the rails 104, such as in the forward direction represented by arrow B, as well as in the backward or retraction movement shown in later embodiments. In some embodiments, the needle / cannula 136 may have a hollow tube portion connected to the fluid reservoir. The needle / cannula 136 may be connected to a fluid path 120 connected to the reservoir 168. The fluid path 120 may have a tube formed from one or more materials such as steel, plastic, or polyvinyl chloride (PVC), but is not limited to these. In some embodiments, the fluid path 120 is fluidically connected to the needle / cannula 136 at a sliding member 128. In an exemplary embodiment, the fluid path 120 has a needle, and the cannula has member 136. The fluid connection between the fluid path 120 and the cannula 136 is a leak-proof structure. In an exemplary embodiment, the fluid path 120 (e.g., needle) can be located inside the cannula 136 and can slide inside the cannula 136. The housing outlet 139 may be configured to guide the fluid path 120 and the cannula 136 into the skin at an appropriate angle and depth to ensure the normal delivery of the liquid drug to the user. Similarly, the housing outlet 137 may be configured to guide the sensor device 112 into the skin at an appropriate angle and depth to ensure the detection of the user's sample.

[0021] Referring further to Figure 1B, the insertion system 180 may have a linkage mechanism 108. As used in this disclosure, “linkage mechanism” is an object configured to directly or indirectly push and / or pull one or more other objects. The linkage mechanism 108 may have, but is not limited to, a spring, a lever, an arm, and / or other mechanism. In some embodiments, the linkage mechanism 108 has a biasing mechanism 142, such as a torsion spring. The biasing mechanism 142 may be configured to rotate clockwise or counterclockwise. Figure 1B shows the biasing mechanism 142 in the pre-deployment position, i.e., the initial position. The biasing mechanism 142 may be actuated by a trigger 140. The trigger 140 may have, but is not limited to, one or more wires, piezoelectric elements, and / or shape memory alloys, and a number of mechanical features such as latches, rods, stoppers, gears, etc., which may be configured to hold or release the biasing mechanism 142 in a “loaded” position or in a “loaded” position. The loading position may be a position where the biasing mechanism 142 has sufficient potential energy to drive the link mechanism 108 that deploys the insertion system. For example, but not limited to, the trigger 140 may have a shape memory alloy (SMA) wire that can activate or otherwise enable the release of the biasing mechanism 142. The SMA wire may be attached to an actuating element. Alternating acts or pulses of the SMA wire may drive the actuating element to rotate back and forth. The actuating element may turn a ratchet gear, which may drive a lead screw or reciprocating element to cause liquid drug to flow from the reservoir of the drug delivery and detection system 100. In some embodiments, a release bar may be connected to or in contact with a portion of the ratchet gear. In some embodiments, the release bar may be released after one or more acts of the actuating element, moving it from its initial or loaded position. The release bar may move away from the loaded position, releasing potential energy and enabling the spring or biasing mechanism of the insertion system to fire. In some embodiments, the SMA wire or other actuation element may be configured to trigger a release mechanism that allows the spring to fire.A spring may be connected to the link mechanism 108 and / or the biasing mechanism 142. In some embodiments, an SMA wire may directly trigger the biasing mechanism 142. The link mechanism 108 may have one or more arms. For example, but not limited to, the link mechanism 108 may have a first arm 108a and a second arm 108b. The first arm 108a of the link mechanism 108 may be connected at one end to the biasing element 142 via a connection point 107. The first arm 108a and the second arm 108b are movably connected by a rotatable joint 109. The connection between the first arm 108a and the second arm 108b of the link mechanism 108 at the joint 109 can be made by one or more rivets, screws, bolts, clips, etc., but is not limited to these. The second arm 108b of the link mechanism 108 may be configured to move linearly or curvilinearly forward and / or backward along the gap 105B (as indicated by arrow B) (as described later with reference to Figure 1C).

[0022] In some embodiments, the link mechanism 108 may be connected to a sliding member 124. The sliding member 124 may be positioned at the end of the second arm 108b of the link mechanism 108. The sliding member 124 may be connected to the second arm 108b via a rotatable joint 109'.

[0023] The sensing element 112 may be connected to a sliding member 116 which can be positioned on the opposite side of the insertion end 114 of the sensing element 112. The sliding member 116 may slide on the rails 104A and 104B and within the gap 105A, so as to enable the sliding member 116 to be firmly guided along the rails 104A and 104B. The sensing element 112 may be positioned adjacent to the gap 105A.

[0024] In operation, Figure 1B shows the initial or pre-deployment position of the insertion system 180.

[0025] Referring next to Figure 1C, the deployment operation of the insertion system 187 is shown. In Figure 1C, the drug delivery system is indicated by reference numeral 100C. The trigger 140 may be connected to the controller 164, the mechanical actuator 190, or both. To deploy the insertion system 180, the trigger 140 may receive a release signal or an input that releases the potential energy of the biasing mechanism 142 to the trigger. In response to the release signal or input, the biasing mechanism 142 may begin to rotate in direction A. In response to the rotational force from the biasing mechanism 142, for example, a rotational force in the direction indicated by the rotation arrow A, the first arm 108a of the link mechanism 108 (and joint 109) may be configured to rotate in the direction of arrow B, pushing the second arm 108b (and joint 109') in the same direction as arrow B. The second arm 108 pushes both sliding member 124 and sliding member 128, with a portion of it positioned within the gap 105B along rails 104B and 104C toward the housing exit 139. The cannula 136 can be positioned adjacent to the gap 105B.

[0026] More specifically, the rotation of the biasing mechanism 142 causes the link mechanism 108, fixed to the joint 107, to move in the direction of arrow B. The rotatable joint 109 connecting the first arm 108a to the second arm 108b moves forward, allowing the first arm 108a to move the second arm 108b along the gap 105B. In addition, the movement of the second arm 108b along the gap 105B also pushes the sliding members 124 and 128 along the gap 105B.

[0027] The sliding member 128 is connected to the fluid path 120 and the cannula 136. The fluid path 120 has sufficient elasticity, flexibility, slack, or a combination thereof to follow the cannula sliding member 128 when the second arm 108b moves the cannula sliding member 128 along the rails 104B and 104C. When the sliding member 128 is pushed by the sliding member 124 and the second arm 108b, the cannula 136 and the fluid path 120 are directed toward the housing exit 139, and the insertion end 137 exits the housing exit 159 with sufficient force to puncture the user's skin and travel an appropriate distance or depth within the skin for subcutaneous delivery of the fluid drug. The appropriate distance can be in the range of about 1 mm to about 8 mm, and preferably about 5 mm, although it is not limited. In other embodiments, the appropriate distance may be greater than or less than 5 mm, but is not limited thereto.

[0028] To ensure that the cannula 136 is held at the appropriate depth in the skin, the sliding member 128 can be held in place and its retraction can be prevented by the catch block 132. The catch block 132 can be configured to resist the movement of the sliding member 128 in the direction opposite to the direction indicated by arrow B, and can be configured to slow the movement of the sliding member 128 in the direction indicated by arrow B during insertion of the cannula 136. The catch block 132 can be made from materials such as plastic, rubber, or damping material, but is not limited to these. The catch block 132 slows the movement of the cannula 136 and the fluid path (e.g., needle) 120 during insertion, so that the insertion speed through the user's skin at the end of the insertion stroke is slower than the insertion speed through the skin at the beginning of the insertion stroke. The catch block 132 can cause this deceleration by frictionally engaging with or damping the movement of the sliding member 128 as it passes over the catch block 132, thereby slowing down but not stopping the insertion process of the cannula 136 forward (e.g., in the direction of arrow "B"). Thus, the catch block 132, which in some exemplary embodiments or in part of its operation can be called a "slowing member" 132, can slow down the movement of the sliding member 128, but at the same time prevent the sliding member 128 from moving backward (e.g., in the direction opposite to arrow "B"). In this sense, the catch block 132 can serve a dual purpose: slowing down the movement of the sliding member 128 in a first direction and stopping the movement of the sliding member 128 in another direction opposite to the first direction. When the catch block 132 functions as a deceleration or damping member, it can delay the insertion of the cannula 136 at the end of its stroke (for example, in the last 1 / 2, 1 / 4, or 1 / 8 of its insertion stroke), delaying the insertion process of the cannula 136 by, for example, 2 ms, 5 ms, 10 ms, 20 ms, 50 ms, or 100 ms. In one embodiment, the catch block 132 may be fixed to one or more rails of the rail 104 by adhesive, welding, or screws.The catch block 132 can fix the sliding member 128 at a predetermined position along the rails 104B and 104C and the cannula 136 at a predetermined insertion distance (for example, beyond the bottom surface of the housing 150). For example, but not limited to, the catch block 132 can fix the cannula 136 so that its distal end extends about 3 to 10 millimeters (mm) from the bottom surface of the housing 150, or in some embodiments, about 3 to 30 mm from the bottom surface of the housing 150.

[0029] While the link mechanism 108 is deployed and the sliding members 124 and 128 are sliding, the sliding member 124 may be connected to the sliding member 116 via one or more arms, protrusions (generally shown as reference number 118), etc.

[0030] For example, the sliding member 116 has one or more projections, such as reference no. 118, which can interact with the sliding member 124 or one or more other elements, such as a notch or stopper formed in or on the end of the sliding member 124 or the damping block 133. For example, but not limited to these, the sliding member 116 may have projections extending toward the gap 105B and the rail 104C, which engage the sliding member 116 with the sliding member 124. During the deployment of the cannula 136 as shown in the embodiment of Figure 1C, the sliding members 124 and 128 may be configured to slide past the projection 118 of the sliding member 116 as the cannula 136 is deployed or inserted. The projection 118 of the sliding member 116 may be configured to engage with the sliding member 124 connected to the second arm 108 when the sliding member 124 and the fluid path (e.g., needle) 120 are retracted in the direction opposite to arrow "B". This may be considered the final stage of cannula 136 deployment.

[0031] After the final stage of cannula deployment is complete, the biasing mechanism 142 continues to rotate in direction A, which is thought to be the start of the retraction movement of the second arm 108b and the sliding member 124 and the deployment of the sensing element 112.

[0032] Figure 1D shows the retraction operation of the insertion system 180. In Figure 1D, the drug delivery system is indicated by reference numeral 100D. The link mechanism 108 may be configured to retract the first arm 108a and the second arm 108b from their extended positions in response to the rotational force provided by the biasing mechanism 142. The catch block 132 is configured to fix or capture the sliding member 128 so that the cannula 136 remains in the deployed position. As shown with reference to Figure 1C, the first arm 108a continues to rotate in direction "A" around the joint 107 that connects the first arm 108a to the biasing mechanism 142. The first arm 108a and the second arm 108b continue to rotate around the joint 109 that connects the first arm 108a to the second arm 108b, allowing the first arm 108a to pull the second arm 108b in direction C, opposite to the direction of arrow B. Direction C may be referred to as the retraction direction or the sensor deployment direction. As the first arm 108a and the second arm 108b retract from their extended positions, the sliding member 124 may be configured to pull a sliding member 116, which can be connected to the sensing element 112, toward the housing exit 114 for the sensing element 112. The sliding member 116 may be guided toward the housing exit 114 by rails 104A and 104B and the gap 105A. The biasing mechanism 142 applies sufficient force to the sensing element 112 in direction C to drive the sensing element 112 into the subcutaneous region of the user's skin to a depth sufficient to obtain accurate measurements of the specimen that the sensing element 112 is configured to measure. With the retraction of the link mechanism 108, the sensing element 112 may be deployed via the movement of the sliding member 124 connected to the sliding member 116. The linkage mechanism 108 may be configured to deploy the cannula 136 through an extension motion and to deploy the sensing element 112 through a retraction motion in a single seamless movement.

[0033] As described above with reference to catch block 132, further catch or damping members may be employed when inserting the sensing element 112. For example, to ensure that the sensing element 112 is held at the appropriate depth in the skin, the sliding member 116 may be held in place and its retraction prevented by catch block 133. The catch block 133 may be configured to resist the movement of the sliding member 116 in direction "B" and may also be configured to decelerate at least a portion of the movement of the sliding member 116 in the direction indicated by arrow "C" when inserting the sensing element 112. The catch block 133 may be made from materials such as plastic, rubber, or damping material, but is not limited to these. The catch block 133 can slow down the movement of the sensing element 112 during insertion so that the insertion speed through the user's skin at the end of the insertion stroke may be slower than the insertion speed through the skin at the beginning of the insertion stroke. The catch block 133 can cause this deceleration by frictionally engaging or damping the motion of the sliding member 116 as it passes over the catch block 133, thereby slowing down but not stopping the insertion process of the sensing element 112 in the forward direction (e.g., in the direction of arrow "C"). Thus, the catch block 133, which in some exemplary embodiments or in part of its operation may be referred to as the “deceleration member” or “damping member” 133, can decelerate the motion of the sliding member 116 while simultaneously preventing the sliding member 116 from moving backward (e.g., in the direction of arrow "B"). In this sense, the catch block 133 can serve a dual purpose: decelerating the motion of the sliding member 116 in a first direction and stopping the motion of the sliding member 116 in another direction opposite to the first direction. If the catch block 133 acts as a deceleration or damping member, it can decelerate the insertion of the sensing element 112 at the end of its stroke (for example, in the last 1 / 2, 1 / 4, or 1 / 8 of its insertion stroke), thereby slowing down the insertion process of the sensing element 112 by, for example, 2 milliseconds, 5 milliseconds, 10 milliseconds, 20 milliseconds, 50 milliseconds, or 100 milliseconds.In one embodiment, the catch block 133 may be fixed to one or more rails of the rail 104 by adhesive, welding, or screws. The catch block 133 may fix the sliding member 116 at a predetermined position along the rails 104B and 104C and the sensing element 112 at a predetermined insertion distance (for example, beyond the bottom surface of the housing 150). For example, but not limited to, the catch block 133 may fix the sensing element 112 such that its distal end extends about 3 to 10 millimeters (mm) from the bottom surface of the housing 150.

[0034] Next, referring to Figure 2A, another embodiment of the insertion system 200 is shown. The insertion system 200 may be used as the insertion system 180 within the drug delivery system 100 described above with reference to Figure 1A. For example, the insertion system 200 may have a trigger 240, a catch block 228, a catch block 229, a sliding member 220, a fluid path 214 (which may include a needle or other conduit), and / or a cannula 232, each of which may have a structure and function similar to the corresponding components described above with reference to Figures 1B to 1D. The insertion system 200 may have a sensing element 224 which may function in a similar manner to the sensing elements described above with reference to Figures 1A to 1D. Furthermore, the cannula 232 of the insertion system 200 may be connected (for example, via the fluid path 214 which may include a needle) to a reservoir configured to contain a liquid drug.

[0035] The insertion system 200 may have rails 204A and 204B. Rails 204A and 204B may be structurally similar to rail 104 described above with reference to Figures 1B to 1D, without limitation. In some embodiments, rails 204A and 204B may be connected together to form a single rail. Rails 204A and 204B may be separated by a gap 205 configured to allow sliding members 216 and 220 to move forward and / or backward along rails 204A and 204B. A sensing element 224 may be connected to the sliding member 216, and a cannula 232 may be connected to the sliding member 220. The connection between the cannula 232 and the sliding member 220 is operable to allow the cannula to move together with the sliding member 220. The fluid path 214 is a conduit connecting a reservoir (not shown in this example) to a cannula 232, and may comprise a needle or other tubular conduit. The cannula 232 may be fluidly connected to the fluid path 214 via a leak-proof coupling at or around the sliding member 220.

[0036] The link mechanism 212 may be the same as that of the link mechanism 108 described above. Similar to the configuration in the embodiments shown in Figures 1B to 1D, the link mechanism 212 may be connected to the biasing element 242 via a joint 207. The link mechanism 212 may have a first arm 212A and a second arm 212B connected together by a joint 209. The link mechanism may be connected to the biasing element 242.

[0037] The biasing element 242 can be a torsion spring or the like, and can store potential energy that can be released by the trigger 240. The trigger 240 can be configured and function similarly to the trigger 140 in Figure 1B.

[0038] In further embodiments, the insertion system 200 may also have an insertion funnel 208 which may be formed from a material such as plastic or metal. The insertion funnel 208 may have an insertion funnel inlet 254 which can lead to a structure that can guide the sensing element 224 toward the exit of the housing. For example, but not limited to, the insertion funnel inlet 254 may be an opening with an inclined wall(s) which can guide the sensing element 224 downward from the exit of the housing for insertion into the user's skin.

[0039] Figure 2A shows a top view of another exemplary insertion system. The insertion system 200 is shown in Figure 2A in its pre-deployment or initial position. The biasing mechanism 242 may be configured in the same manner as the biasing mechanism 142 described with reference to the embodiments of Figures 1B to 1D. The trigger 240 may be operable to release the biasing mechanism 242 in response to receiving an input (in the same manner as described above with reference to Figures 1B to 1D).

[0040] Next, referring to Figure 2B, the deployment operation of system 200 is shown with reference to a top view of system 200. The biasing mechanism 242 is activated and may begin to move counterclockwise or rotate in the L direction, as indicated by arrow L. Rotation in the L direction may extend the first arm 212A and / or the second arm 212B of the positioning element 212. The second arm 212B of the positioning element 212 may be attached to the sliding member 216 of the sensing element 224. Extending the second arm 212B may push the sliding member 216 against the sliding member 220 of the injection device 232. When the second arm 212B is extended, the sliding members 216 and 220 are guided in direction M (indicated by arrow M) by the gap 205 along rails 204A and 204B, which force the cannula 232 toward the housing exit 255. The fluid path 214 has sufficient elasticity, flexibility, and / or slack, allowing it to move with the sliding member 220 and remain fluidly connected to the cannula 232. The insertion end of the cannula 232 (not shown in this example) is movable to penetrate the user's skin to an appropriate depth to allow delivery of the liquid drug.

[0041] When the second arm 212B reaches its full extension, the catch block 228 may be able to operate to lock the second sliding block 220 in a predetermined position, preventing the sliding member 220 from retracting toward the biasing mechanism 242, and also assisting in maintaining the cannula 232 in a predetermined position within the user's skin. The catch block 228 may also function to slow down the insertion of the cannula 232 for at least part of its insertion stage, in the same manner as described above with reference to Figures 1B to 1D.

[0042] While the second arm 212B reaches its full extension, the biasing member 242 continues to rotate to retract the sliding member 216 and deploy the sensing element 224.

[0043] Furthermore, during the deployment of the cannula 232, the sensing element 224 is pulled across the insertion funnel 208 and past the insertion funnel inlet 254. This prepares the insertion system 200 to deploy the sensing element 224 during the retraction movement of the insertion system 200.

[0044] Next, referring to Figure 2C, the retraction movement of the insertion system 200 is illustrated. As the biasing member 242 continues to rotate the first arm 212A of the positioning element 212 counterclockwise (direction L), the first arm 212A pulls the second arm 212B in direction N, which is opposite to direction M in Figure 2B. As shown in Figure 2C, the first arm 212A and the second arm 212B rotate around the joint 209, and the sliding member 216 connected to the end of the second arm 212b is also pulled in direction N. As the sliding member 216 begins its movement in direction N, the end of the sensing element 224 can fall into the insertion funnel inlet 254 as the pre-insertion position relative to the insertion funnel 208. As the biasing mechanism 242 continues to cause rotation in the L direction, the sliding member 216 drives the detection element 224 into the insertion funnel 208, exits the housing outlet (not shown in this embodiment), and punctures the user's skin.

[0045] Figure 2D shows a side view of system 200 of an exemplary embodiment shown in Figure 2A. Figure 2D shows the operation of system 200 before deployment. System 200 may have a wire 236. The wire 236 may be made of copper, silver, or other wires, but is not limited to these. The wire 236 may be configured to provide an electrical connection between the sensing element 224 and the circuit 253. The circuit 253 may have one or more resistors, capacitors, transistors, inductors, etc. The circuit 253 may have a printed circuit board (PCB). The wire 236 may be connected to a sliding member 216 of the sensing element 224. The sensing element 244 may be positioned above the insertion funnel 208 in the pre-deployment stage. The insertion funnel 208 may have a rigid structure made of plastic and / or other materials. The insertion funnel 208 may have a first wall and a second wall. The first wall of the insertion funnel 208 may be in the shape of a right triangle. In some embodiments, the first wall of the insertion funnel 208 may be shaped as a square, rectangle, or other shape. The first wall of the insertion funnel 208 may be positioned close to the biasing mechanism 242. In some embodiments, the distal end of the sensing element 224 may abut against the upper surface of the insertion funnel 208. For example, the left distal end of the sensing element 224 may abut against the left wall of the insertion funnel 208. The left wall of the insertion funnel 208 may be positioned close to the insertion funnel inlet 254. The left wall of the insertion funnel 208 may be formed as a right triangle with a hypotenuse extending outward from the center of the insertion funnel inlet 254, for example toward the sensing element 224. The insertion funnel 208 may have a right wall that can be positioned opposite the left wall of the insertion funnel 208. The right wall of the insertion funnel 208 may be composed of a rigid structure such as plastic and / or other material, but is not limited to this. The right wall of the insertion funnel 208 may be molded as a right triangle, square, rectangle, or other shape. In one example, the right wall of the insertion funnel 208 is positioned close to the catch block 228. For example, the right side of the right wall of the insertion funnel 208 may contact the side of the biasing mechanism 242, such as the left side of the biasing mechanism 242. In some embodiments, the right wall of the insertion funnel 208 may be positioned on the opposite side from the left wall of the insertion funnel 208. The left and right walls of the insertion funnel 208 may be spaced apart by, for example, 1 mm to 10 mm, but are not limited to these.In some embodiments, where the left and right walls of the insertion funnel 208 are right triangles, the respective hypotenuses of each wall may extend toward the center of the first housing outlet 257. The left and right walls of the first insertion funnel 208 may form a gap 244. The gap 244 may be inclined or rotated with a radius of curvature, so that the sensing element 224 may be guided obliquely into the first housing outlet 257. For example, the sensing element 224 may be angled downward toward the first housing outlet 257 at an angle of about 10 to about 90 degrees. The gap 244 may have a length of about 2 mm, but is not limited to that. The gap 244 may have a width of about 1.5 mm, but is not limited to that.

[0046] In the pre-deployment position shown in Figure 2D, the sliding member 216 and the sliding member 220 may be positioned close to each other. For example, the sliding member 216 and the sliding member 220 may be in physical contact with each other, such as through one or more sides of the sliding member 216 and the sliding member 220. The sliding member 216 may have a distal end such as a sensing element 224 positioned on the opposite side from the distal end of the sliding member 220, such as a cannula 232. In the pre-deployment position, the cannula 232 may extend at a downward angle relative to the sliding member 220. For example, the cannula 232 may be angled downward by about 15 degrees from the sliding member 220 toward the second insertion funnel inlet 255. The housing outlet 255 may be the same as the first housing outlet 257. The housing outlet 255 may be positioned to the right of the sliding member 220. In some embodiments, in the pre-deployment position, the distal end of the cannula 232 may be positioned about 0.5 mm to about 5 mm or about 3 mm to 10 mm away from the housing outlet 255. In some embodiments, the distal end of the cannula 232 may be positioned about 2 mm away from the housing outlet 255.

[0047] Next, referring to Figure 2E, a side view of the system 200 in the extended position is presented. In response to a trigger of the biasing mechanism 242, the first arm 212A and / or the second arm 212B can push the sliding member 216 and / or the sliding member 220 in direction L. The first arm 212A can be moved in direction L by the biasing element 242 in the manner described above with reference to Figure 2C. The second arm 212B can apply force to the sliding member 216. In some embodiments, the sliding member 216 can apply the force received from the second arm 212B to the surface of the sliding member 220. During the movement in direction L, the cannula 232 of the second sliding element 220 can be pushed toward the housing exit 255. In this embodiment, the angled position of the cannula 232 allows the cannula 232 to enter the housing exit 255, while the sliding member 220 can move in the L direction.

[0048] While the sliding member 216 moves in direction L, the wire 236 may move along with the surface of the sliding member 216 by stretching, bending, flexing, and / or other means. For example, the first end or upper end of the wire 236 may be bent or flexed horizontally in direction L toward the second end or lower end of the wire 236. In some embodiments, the wire 236 may be bent or flexed in half. In other embodiments, the wire 236 may be bent or flexed to various lengths relative to the wire 236, for example, about 3 / 4 of the total length of the wire 236. The wire 236 may be attached to the sliding member 216 by adhesive or another mounting method and pulled in direction L by the sliding member 216.

[0049] Next, referring to Figure 2F, the retraction operation of the system 200 is shown. Referring to Figure 2C, the biasing element 242 described above may continue to rotate so as to move the first arm 212A and / or the second arm 212B in direction M. Direction M may be a linear direction, such as away from the biasing mechanism 242 and toward the biasing mechanism 242. The second arm 212B may retract the sliding member 216 from the sliding member 220. For example, the second arm 212B may move in direction M, and the sliding member 216 may also move in direction M. The sliding member 216 may continue in the path toward direction M until the biasing mechanism 242 stops retracting the sliding member 216. The sensing element 224 of the sliding member 216 may move into the first housing exit 257 through the insertion funnel 208. The insertion funnel 208 can guide the sensing element 224 into the first housing outlet 257 as the second arm 212B moves in direction M. In some embodiments, the sensing element 224 may contact the upper surface of the right wall of the insertion funnel 208. In some embodiments, the sensing element 224 may contact the bottom surface of the left wall of the insertion funnel 208. The sensing element 224 may be inserted only about 1 mm to about 30 mm, less than 1 mm, or more than 30 mm, but is not limited to these. For example, the sensing element 224 may be inserted only about 5.5 mm into the first housing outlet 257. The biasing mechanism 242 and / or the second arm 212B may fix the sensing element 224 into the first housing outlet 257 through the first sliding member 116 of the positioning arm. The wire 236 may return from a bent position and / or a curved position to a relaxed position as shown in Figure 2D. The wire 236 can maintain an electrical connection between the sliding member 216 and the circuit 253, thereby allowing the sensing element 224 to be positioned and communicate biological data with the circuit 253.

[0050] In Figure 2F, the sliding member 220 can be fixed in an extended position relative to the housing outlet 255. The cannula 232 can be positioned within the housing outlet 255. The sliding member 220 can fix the cannula 232 and the needle (shown in a retracted state, indicated by the dashed line) within the housing outlet 255. For example, the cannula 232 can be inserted and / or positioned to a depth of approximately 1 mm to approximately 30 mm, less than 1 mm, or more than 30 mm. For example, the cannula 232 can be inserted into the housing outlet 255 to a depth of approximately millimeters or so to deliver a liquid drug.

[0051] Figure 2G shows a dual insertion system in another embodiment. The dual insertion system 200G may have an electrical contact 248 instead of the wire 236 of the dual insertion system 200 shown in Figures 2A to 2F. In this embodiment, the electrical contact 248 may be positioned on the upper part of the surface of the circuit 253a. The electrical contact 248 may be positioned at the center of the circuit 253a. The electrical contact 248 may be in contact with the sensing element 224a and / or the sliding member 216a in the pre-deployment position. The sensing element 224a may be the same as the sensing element 224 in Figures 2A to 2F, except for the form of the electrical connection between the sensing element 224a and the electrical contact 248. Similarly, the sliding member 216a may be substantially the same as the sliding member 216, except for the form of the electrical connection between the sensing element 224a and / or the electrical contact 216a. The electrical contact 248 can establish electrical contact with the sensing element 224a and / or the sliding member 216a, enabling the sensing element 224a to provide. The electrical contact 248 can be raised via the bridge 262. The bridge 262 can be operable to extend the electrical contact 248 and / or retract the electrical contact 248 to a vertical position. For example, the bridge 262 can extend the electrical contact 248 by about 1 mm, thereby allowing the electrical contact 248 to contact the sensing element 224a and the sliding member 216a. The bridge 262 may, but is not limited to, an actuator, an electromechanical motor, a biasing element, an elastic structure, etc. The electrical contact 248 may, but is not limited to, a conductive material such as copper or silver. The bridge 262 may be conductive, thereby enabling an electrical connection between the electrical contact 248 and the circuit 253a.

[0052] Next, referring to Figure 2H, the deployment of system 200G is shown. The first arm 212A and / or the second arm 212B can push in the sliding members 216a and / or 220, as described above with reference to Figure 2E. In this embodiment, the first arm 212A and the second arm 212B move the sliding member 216a in the Y direction, thereby inserting the cannula 232 into the housing exit 255 and aligning the sensing element 224a above the gap 244 in the insertion tunnel 208. During the deployment of system 200G, the sliding member 220 may push the cannula 232 or otherwise move it toward the housing exit 255. The cannula 232 may have an angle, as described above with reference to Figure 2E. The electrical contact 248 may retract through the bridge 262 during the deployment of system 200G. In one embodiment, the electrical contact 248 can retract approximately 0.5 mm away from the first arm 212A and the second arm 212B towards the circuit 253.

[0053] Next, referring to Figure 2I, the retraction of system 200G is presented. The first arm 212A and the second arm 212B can retract in direction T. The second arm 212B can pull the sliding member 216a in direction T and / or move it in other ways. The retraction of the sliding member 216a in direction T may be as described above with reference to Figure 2H. The sliding member 116 can move in direction T so that the sliding member 216a can be aligned with the electrical contact 248. The electrical contact 248 may be in contact with the surface of the sliding member 216a, such as the bottom of the sliding member 216a, or in other ways. During the deployment movement, the sensing element 224 may enter the gap 244 and / or the housing exit 257 as described above with reference to Figure 2H. The sensing element 224a can collect and / or generate biological data and communicate the biological data to the circuit 253 via the electrical contact 248. The sliding member 220 can remain in the deployed position together with the cannula 232 inserted into the user's skin, as described above in relation to the embodiments in Figures 2A to 2F.

[0054] Referring next to Figure 3A, another embodiment of the insertion system 300 is presented. The system 300 may have a positioning element 346. The positioning element 346 may have a first arm 346A, a second arm 346B, and / or a third arm 346C. The first arm 346A may be positioned to the left of the third arm 346C, and the second arm 346B may be positioned to the right of the third arm 346C, but is not limited thereto. A biasing mechanism 342 may be a spring or other form of force application element connected to the positioning element 346 and operable to apply a rotational force to, for example, the third arm 346C of the positioning element 346. The biasing mechanism 342 may be operable to store potential energy. A trigger 340 may be connected to the biasing mechanism 342. The trigger 340 may be operable to release the potential energy stored by the biasing mechanism 342. Trigger 340 is configured and may function similarly to trigger 240 described above with reference to Figure 2A. Each arm 346A and 346B of the positioning element 346 may be operable to move substantially linearly, as will be further described later with reference to Figure 3B, while arm 346C may be operable to rotate. Furthermore, the first arm 346A is substantially alignable with the gap 305 of the first rail 304.

[0055] The first rail 304 may have one or more straight structures 304A and 304B. In some embodiments, the first rail 304 may have two straight structures 304A and 304B of the first pair, separated by a gap 305. The first sliding member 332 may be positioned on and / or housed within the gap 305 between the first pair of rails 304A and 304B. The sensing element 324 may extend distally from the left side of the first sliding member 332 toward the housing exit 354. The first capture element 328 may be positioned on and / or otherwise located on the rails of a pair of rails 304A and 304B. For example, the first capture element 328 may be positioned on the top rails of one or both of rails 304A or 304B. The first capture element 328 may, but is not limited to, rubber, plastic, etc. Furthermore, the capture element 328 can slow down the insertion of the cannula 362 during at least a portion of its insertion stage, in a manner similar to that described above, with reference to Figures 1B to 1D.

[0056] The detection element 320 may have a first drilling element 324. The first drilling element 324 may, but is not limited to, a steel trocar, a needle, and / or other device. The first drilling element 324 may be positioned inside the detection element 320. For example, the detection element 320 may have a tubular structure in which the first drilling element 324 may be located.

[0057] The second arm 346B can be positioned within the gap 309 of the second rail 308. The second rail 308 may be the same as the first rail 304. The second rail 308 may have a first rail 308A and a second rail 308B.

[0058] The second rail 308 can guide the second sliding member 334 through the gap 309 between rails 308A and 308B of the second rail 308. The second sliding member 334 can be connected to a cannula 362. The cannula 362 can be manufactured from a flexible and expandable material such as a plastic tube. The cannula 362 can be positioned toward the second housing outlet 358, and the sensing element 324 can be positioned toward the first housing outlet 354, but is not limited thereto. The cannula 362 may also be configured to have a second perforating element 316 which is fluidically connected to a fluid path to a reservoir (as shown in the previous embodiment) that holds a liquid drug. The second perforating element 316 may be the same as that of the first perforating element 324. In some embodiments, the second perforating element 316 may be a needle, a steel trocar, and the like, but is not limited thereto. The second rail 308 may have a second capture element 338, which may be made of rubber, plastic, or the like, but is not limited to these materials. The capture element 338 may also function to slow down the insertion of the detection element 324 for at least a portion of its insertion stage, in a manner similar to that described above with reference to Figures 1B to 1D.

[0059] Next, referring to Figure 3B, the deployment stage of system 300 is shown. Rotatable connecting parts 347A and 347B connect the arm 346C to the respective arms 346A and 346B. The third arm 346C can rotate in direction R, thereby allowing the first arm 346A to move in direction S and the second arm 346B to move in direction T. The first arm 346A can move in direction S, thereby allowing the sliding member 346D to push the first sliding member 332 in direction S. When pushed by the first sliding member 346C, the first sliding member 332 moves the sensing element 320 into the first housing exit 354. The second arm 346B can be moved in direction T through the rotation of the third arm 346C. The second sliding member 334 is pushed in the T direction by the sliding member 346E connected to the second arm 346B, allowing the cannula 362 to move toward the second housing exit 358. During the T-direction movement of the second arm 346B, the first perforating element 316 can be inserted into the second housing exit 358. Similarly, the first perforating element 324 can move toward the first housing exit 354 in direction S.

[0060] The first sliding member 332 can be held in a predetermined position by the first capturing element 328 (and the sensing element 320 is held in its deployed position), and the second sliding member 334 can be held in that position (and the cannula 362 is held in its deployed position). The "deployed position for the sensor" is, for example, when the sensor 320 is in the subcutaneous region of the patient's skin, and the "deployed position for the cannula 362" is, for example, when the cannula 362 is in the subcutaneous region of the patient's skin.

[0061] Next, referring to Figure 3C, the retraction phase of system 300 is shown. The third arm 346C can continue to dissipate energy and move in direction R, thereby moving the first sliding member 346D in direction U and the second sliding member 346E in direction V. During the retraction phase, the first arm 346A can move the first drilling element 324 out of the first housing exit 354 in direction U. The first capture element 328 of the first rail 304 can provide resistance to the movement of the first sliding member 332 in direction U. The second arm 346B can move the second sliding member 346E in direction V, thereby moving the second drilling element 316 in direction V. The second capture element 338 can provide resistance to the movement of the second sliding member 334 in direction V. The second capturing element 338 can fix the second sliding member 334 in a predetermined position, and can fix the cannula 362 in its deployed position.

[0062] Next, referring to Figure 4A, a double deployment system 400 having a single set of rails is presented. System 400 is shown in its pre-deployment position. System 400 may have a first arm 412A and / or a second arm 412B. The first arm 412A may be connected to a biasing element 460. The biasing element 460 may be the same as the biasing element 242 as described above with reference to Figure 2A. A trigger 440 may activate the biasing element 460. The trigger may be had or configured in the same way as the trigger 240 as described above with reference to Figure 2A. System 400 may have a set of rails 404. A set of rails 404 may have one or more rigid straight structures. A set of rails 404 may have a set of two straight structures with a gap between the two straight structures. A pair of rails 404 can guide both a first sliding member 420 and a second sliding member 424. The first sliding member 420 may be oriented opposite to or adjacent to the second sliding member 424. For example, the first sliding member 420 may be connected to a sensing element 432 that extends outward from the rail 404 toward an insertion guide structure 408, and the second sliding member may have a cannula 474 that extends outward from the rail 404 toward a second housing exit 470. The first rail of rail 404 may have a catch block 436. The catch block 436 may be positioned at the center, end, and / or other lengths of the first rail. In some embodiments, the catch block 436 may be the same as the catch block 228 described above with reference to Figure 2A. The insertion guide structure 408 may have an outer structure supporting an inner structure that can guide the sensing element 432 into the first housing exit 464. The sensor 428 may be configured to be attached to the first sliding member 420, for example, through one or more protrusions. The second sliding member 424 may be connected to and / or housed in the first drilling element 416. The first drilling element 416 may have the first drilling element 214, or similarly, as described above with reference to Figure 2A.

[0063] Next, referring to Figure 4B, the deployment stages of the dual deployment system 400 are presented. A biasing element 460 can be activated by a trigger 440. In some embodiments, the biasing element 460 can rotate in direction R. The biasing element 460 can rotate the first arm 412A in direction R. The second arm 412B can press the first sliding member 420 toward the second sliding member 424, for example, through direction Q. A sensor 432 can be attached to the first sliding member 420 while the second arm 412B is moving in direction Q. A cannula 474 can be inserted into the second housing exit 470 through the movement of the second arm 412B in direction Q. In some embodiments, a first piercing element 416 can be inserted into the second housing exit 470.

[0064] Next, referring to Figure 4C, the retraction phase of the dual deployment system 400 is shown. The biasing element 460 rotates in direction R, thereby rotating the first arm 412A in direction R and moving the second arm 412B in direction P. The second arm 412B can move the first sliding member 420 in direction P. The sensing element 432 can be inserted into the insertion guide structure 408. The insertion guide structure 408 may have one or more guide structures that can guide the sensing element 432 into the first housing exit 464. The first drilling element 416 can move in direction P through the second arm 412B, thereby retracting the first drilling element 416 from the second housing exit 470. The capture element 436 can oppose the movement in direction P and fix the second sliding member 424 in the deployed position.

[0065] Next, referring to Figure 4D, a side view of a double deployment system 400 according to one embodiment is shown. The system 400 is shown in the pre-deployment position. The first arm 412A and the second arm 412B may be in the pre-deployment configuration. In some embodiments, the first sliding member 420 and the second sliding member 424 may be positioned adjacent to each other. The first sliding member 420 and the second sliding member 424 may be positioned on and / or between a pair of rails 404. In some embodiments, a wire 448 may be connected to an interconnector 428. The interconnector 428 may have one or more projections, extending members, etc., which may be located on one side of the rails of the two rails 404, opposite to the first sliding member 420 and the second sliding member 424. For example, the first sliding member 420 and the second sliding member 424 may be positioned on the upper surface of the rail 404, and the interconnector 428 may be positioned on the bottom surface of the rail 404.

[0066] The interconnector 428 may have one or more projections (not shown) that can extend from the bottom surface of the rails to the side surface / around the side surface of one of the two rails 404, or into the gap between a pair of rails 404 to reach the top surface of the rails 404. For example, without limitation, the interconnector 428 may have an arm that can extend from the interconnector 428 to the top of the rails 404. In some embodiments, a wire 448 may connect to the interconnector 428 and / or the circuit 444. The wire 448 may have a conductive element such as copper, aluminum, or silver, without limitation. The wire 448 may be similar to the wire 236 and function as described above with reference to Figure 2D. In some embodiments, the wire 448 may have a first end and a second end. The first end of the wire 448 may be folded back horizontally toward the second end of the wire 448. The wire 448 may be bent in the positive direction across the x-axis. Wire 448 can be positioned to the right and / or center of circuit 444. The electrical connection between circuit 444 and interconnector 428 can be maintained via wire 448. Circuit 444 may be a processor or sensor circuit that can operate to generate measurement data from physiological attribute information detected by sensor device 432.

[0067] Next, referring to Figure 4E, a side view of the dual deployment system 400 in the deployment stage is shown. In this embodiment, the first arm 412A may move by rotation or by other means, which may move the second arm 412B. The second arm 412B may move the first sliding member 420 and / or the second sliding member 424 in direction T. A pair of rails 404 may provide structural support and / or guidance for the movement of the first sliding member 420 and the second sliding member 424 in direction T. The cannula 474 of the second sliding member 424 may be inserted into the second housing exit 470 during the movement of the second sliding member 424 in direction Q. The cannula 474 may be angled downward, such as 15 degrees relative to the rails 404, but is not limited to this angle. The interconnector 428 may be physically attached to the first sliding member 420. For example, the arms or other components of the interconnector 428 may connect the interconnector 428 to the first sliding member 420 by clipping, snapping, hooking, or other means, covering the side of the rail 404. The wire 448 may remain in the bent position as described above.

[0068] Next, referring to Figure 4F, a side view of the retracted dual deployment system is shown. The second arm 412B can retract in direction S through the first arm 412A which moves in direction S, or it can move in another way. The second arm 412B can move the first sliding member 420 in direction S, thereby moving the sensing element 432 toward / into the first housing exit 464. The sensing element 432 can be angled downward with respect to a pair of rails 404, without limitation, at angles such as about 10 to 90 degrees, less than 10 degrees, or greater than 90 degrees. The second sliding member 424 can be fixed in the deployed position, thereby allowing the cannula 474 to remain inside the second housing exit 470. The perforating element 416 can move in direction P, thereby retracting the perforating element 416 from the second housing exit 470. Fluids, such as fluid-based drugs, may be delivered to the second insertion funnel inlet 470 through the cannula 474 after the retraction of the perforating element 416, although this is not restricted.

[0069] Wire 448 may extend in direction P by pulling interconnector 428 in direction P. Wire 448 may maintain an electrical connection between circuit 444 and interconnector 428. Interconnector 428 may be connected to and / or communicate with sensing element 432. Sensing element 432 may be positioned within the first housing exit 464 and may collect and / or generate biological data that can be communicated to circuit 444 through wire 448.

[0070] Next, referring to Figure 4G, a side view of the dual deployment system 400G in the pre-deployment stage is shown. System 400G may be the same as system 400D described above with reference to Figure 4D. System 400G may have electrical contacts 452. Electrical contacts 452 may be the same as electrical contacts 248 described above with reference to Figure 2G. Electrical contacts 452 may be manufactured from silver, copper, aluminum, etc., but are not limited to these materials. In some embodiments, electrical contacts 452 may be connected to and / or positioned in a bridge 453. The bridge 453 may have an actuator, an electromechanical motor, or other device that can extend and / or retract vertically. The bridge 453 may be conductive, thereby providing an electrical connection between the electrical contacts 453 and the circuit 444. Electrical contacts 452 may be positioned in the center, left side, or right side of the circuit 444.

[0071] Next, referring to Figure 4H, a side view of the deployed stage of the dual deployment system 400G, which includes an electrical contact 452, is shown. A biasing element 436 can be activated via a trigger 440, as shown in Figure 4G. The biasing element can move the first sliding member 420 in direction S. The first sliding member 420 can push or otherwise apply force to the second sliding member 424, thereby moving the second sliding member 424 in direction S. The cannula 470 can move in direction S and enter the second housing exit 474. The interconnector 428 can be connected to the first sliding member 420 as described above with reference to Figure 4G.

[0072] Next, referring to Figure 4I, a side view of the retracted stage of the dual deployment system 400G is shown. A biasing element 436 rotates, thereby allowing the first arm 412A and / or the second arm 412B to move in direction P. The second arm 412B allows the sliding member 420 to move in direction P. The interconnector 428 may move with the first sliding member 420 via physical attachments such as hooks, loops, or straps. The interconnector 428 may provide a connection between an electrical contact 452 and a sensing element 432. The sensing element 432 may be pushed into or otherwise inserted into the first housing exit 464. The sensing element 464 may collect biological data that can be communicated to a circuit 444 through an electrical contact 452 that can contact the interconnector 428. The second sliding member 424 may remain in the deployed position together with a cannula 470 held within the second housing exit 474. The piercing element 416 can be retracted through movement in direction P by the first sliding member 420 and / or the second arm 412B. The cannula 470 can be operated to deliver one or more fluids into the second housing outlet 474 after the piercing element 416 has retracted.

[0073] Next, referring to Figure 5, a block diagram of the drug delivery system 500 is illustrated. In some embodiments, the drug delivery system 500 is suitable for delivering drugs such as insulin to a user according to the disclosed embodiments. The drug delivery system 500 may have a wearable drug delivery device 502, a controller 504, and a sample sensor 506. Furthermore, the drug delivery system may interact with a computing device 532 via a network 508 and may also acquire or provide cloud-based services 510.

[0074] Referring still to Figure 5, the wearable drug delivery device 502 can be a wearable device attached to the user's body. The wearable drug delivery device 502 can be similarly obtained as the wearable drug delivery and detection system 100. The wearable drug delivery device 502 can be directly connected to the user (for example, attached directly to the user's skin at various locations on the user's body, such as the thigh, abdomen, or upper arm, via an adhesive). In one embodiment, the surface of the wearable drug delivery device 502 may have an adhesive to facilitate attachment to the user's skin.

[0075] Referring still to Figure 5, the wearable drug delivery device 502 may have a processor 514. The processor 514 can be implemented in hardware, software, or any combination thereof. The processor 514 may be, for example, a microprocessor, logic circuit, field-programmable gate array (FPGA), application-specific integrated circuit (ASIC), or a microprocessor coupled to memory. The processor 514 may be capable of holding data and performing other functions (e.g., calculations). The processor 514 may be capable of executing an automated insulin delivery (AID) application 526 stored in memory 512, which enables the processor 514 to direct the operation of the wearable drug delivery device 502. The AID application 526 may control insulin delivery to the user for each AID algorithm. Memory 512 may store the user's AID application settings, such as specific factor settings, subjective insulin needs parameter settings, and AID algorithm settings such as maximum insulin delivery, insulin sensitivity settings, and total daily insulin (TDI) settings. Furthermore, the memory can store data such as drug delivery dose, blood glucose measurements, and ketone levels.

[0076] Referring still to Figure 5, the sample sensor 506 may be configured to collect physiological status data that can be shared with the wearable drug delivery device 502, the controller 504, or both, such as blood glucose measurements and timestamps, ketone levels, heart rate, and blood oxygen levels. For example, the communication circuit 542 of the wearable drug delivery device 502 may be configured to communicate with the sample sensor 506 and the controller 504, as well as with devices 530, 533, and 534. The communication circuit 542 may be configured to communicate via Bluetooth®, Wi-Fi®, short-range wireless communication standards, cellular standards, or any other wireless protocol. In one embodiment, the wearable drug delivery and detection system 100 may be a combination of the wearable drug delivery device 502 and the sample sensor 506.

[0077] Still referring to Figure 5, the input / output device 545 may be one or more of the following: a microphone, speaker, vibrator, display, push button, touchscreen display, tactile input surface, etc. The input / output device 545 may be connected to the processor 514 and may have circuits that can operate to generate a signal based on the received input and supply the generated signal to the processor 514. Furthermore, the input / output device 545 may be operated to receive a signal from the processor 514 and generate an output through its respective output device based on the received signal.

[0078] Referring still to Figure 5, the wearable drug delivery device 502 may have a reservoir 511. The reservoir 511 may be operable to store drugs or therapeutic agents suitable for automatic delivery of drugs, such as insulin, morphine, methadone, hormones, glucagon, glucagon-like peptides, GIP, antihypertensive drugs, chemotherapeutic drugs, combinations of drugs such as insulin and glucagon-like peptides, or similar. A fluid pathway to the user may be provided via a tube and a needle / cannula (not shown). The fluid pathway may have a tube connecting the wearable drug delivery device 502 to the user (for example, via a tube connecting a needle or cannula to the reservoir 511). Based on control signals from the processor 514, the wearable drug delivery device 502 may be operable to discharge drugs, drugs, or therapeutic agents such as insulin from the reservoir 511 and deliver a dose of drugs, drugs, or therapeutic agents such as insulin to the user via the fluid pathway. For example, the processor 514 may be configured to operate in such a way as to drain insulin from the reservoir 511 by sending a control signal to the pump 518.

[0079] Referring still to Figure 5, there may be one or more communication links 598 to one or more devices physically separated from the wearable drug delivery device 502, for example, having a controller 504 and / or sensor 506 for the user and / or the user's caregiver. The sample sensor 506 may communicate with the wearable drug delivery device 502 via a wireless communication link 531 and / or with the controller 504 via a wireless communication link 537. The communication links 531, 537 and 598 may have wired or wireless communication paths operating according to any known communication protocol or standard, such as Bluetooth®, Wi-Fi®, short-range wireless communication standards, cellular standards, or other wireless protocols.

[0080] Still referring to Figure 5, the wearable drug delivery device 502 may also have a user interface 516, such as an integrated display device, for displaying information to the user and, in some embodiments, for receiving information from the user. For example, the user interface 516 may have a touchscreen and / or one or more input devices, such as buttons, knobs, or a keyboard, which allow the user to provide input.

[0081] Referring still to Figure 5, the processor 514 may also be operable to receive data or information from other devices such as the specimen sensor 506 and smart accessory device 530, fitness device 533, or another wearable device 534 (e.g., a blood oxygen sensor), which may be operable to communicate with the wearable drug delivery device 502. For example, the fitness device 533 may have a heart rate sensor and be operable to provide heart rate information, etc.

[0082] Referring still to Figure 5, the wearable drug delivery device 502 can interface with (communicate with) the network 508. The network 508 can be a local area network (LAN), a wide area network (WAN), or a combination thereof, and can operate to wirelessly connect to the wearable drug delivery device 502, the controller, and devices 530, 533, and 534. The computing device 532 can interface with the network 508, and the computing device can communicate with the insulin delivery device 502. The computing device 532 is a healthcare provider device, a parental computer, etc., and the user's controller 504 interacts with these devices to obtain information, store settings, etc. The AID application 520 can execute the AID algorithm and can operate to present a graphical user interface to the computing device 532 that enables input and presentation of information related to the AID algorithm. The computing device 532 can be used by a healthcare provider, a parent of the user of the wearable drug delivery device 502, or another user.

[0083] Referring still to Figure 5, the drug delivery system 500 may include a sample sensor 506 for detecting the level of one or more samples of the user, such as blood glucose levels, ketone levels, or other samples related to the diabetes treatment plan. The detected sample level values ​​may be used as physiological state data and transmitted to the controller 504 and / or the wearable drug delivery device 502. The sensor 506 may be attached to the user, for example by adhesive, and may provide information or data regarding one or more of the user's medical conditions and / or physical characteristics. The sensor 506 may be a continuous glucose monitor (CGM), a ketone sensor, or another type of device or sensor that provides blood glucose measurements, capable of providing blood glucose concentration measurements. The sensor 506 may be physically separate from the wearable drug delivery device 502, or may be an integrated component thereof. The sample sensor 506 may provide the processor 514 and / or processor 519 with physiological state data indicating the user's measured or detected blood glucose levels. The information or data provided by the sensor 506 can be used to modify the insulin delivery schedule, thereby causing adjustments to the drug delivery operation of the wearable drug delivery device 502.

[0084] Still referring to Figure 5, in the illustrated example, the controller 504 may have a processor 519 and a memory 528. The controller 504 may be a special-purpose device, such as a dedicated personal diabetes management (PDM) device. The controller 504 may be any portable electronic device, such as a smartphone, smartwatch, fitness device, or tablet, and may be a programmed general-purpose device having a dedicated processor, such as a processor or microprocessor. The controller 504 may be used to program or regulate the operation of a wearable drug delivery device 502 and / or sensor 506. The processor 519 may perform processing to manage the user's blood glucose level and control the delivery of drugs or therapeutic agents (e.g., the liquid drugs mentioned above) to the user. The processor 519 may also be operable to execute programming code stored in the memory 528. For example, the memory 528 may be operable to store an AID application 520 for execution by the processor 519. The AID application 520 may be responsible for controlling a wearable drug delivery device 502, including automatically delivering insulin based on instructions from the AID algorithm, such as the recommendations and instructions described in this specification.

[0085] Referring still to Figure 5, memory 528 can store one or more applications, such as AID application 520, and data 539 that may be the same as or substantially the same as those described above with reference to the insulin delivery device 502. Furthermore, setting values ​​521 may store information such as drug delivery history, long-term blood glucose measurements, and total daily insulin values. Memory 528 may be further operable to store data and / or computer programs 539, etc. The memory can also store AID setting values ​​and parameters, insulin treatment plan history (insulin delivery history, blood glucose measurement history, etc.). Other parameters such as insulin load (IOB) and insulin-to-carbohydrate ratio (ICR) can be retrieved from the presets and insulin history stored in memory. For example, AID application 520 may be operable to store AID algorithm settings such as blood glucose target setting values, insulin delivery constraints, basal delivery rate, insulin delivery history, and the status of the wearable drug delivery device. Furthermore, memory 528 may be capable of storing data such as a food database containing carbohydrate (or macronutrient) information for food ingredients (e.g., grilled cheese sandwiches, coffee, hamburgers, branded grains, etc.). Memory 528 is accessible from the AID application 520.

[0086] Still referring to Figure 5, the input / output device 543 of the controller 504 may be one or more of the following: a microphone, speaker, vibrator, display, push button, tactile input surface, touchscreen, etc. The input / output device 543 may be connected to the processor 519 and may have a circuit that can operate to generate a signal based on the received input and supply the generated signal to the processor 519. Furthermore, the input / output device 543 may be operated to receive a signal from the processor 519 and generate an output based on the received signal through one or more respective output devices such as a speaker, vibrator, or display.

[0087] Still referring to Figure 5, the controller 504 may have a user interface 523 for visual communication with the user. The user interface 523 may have a display device, such as a touchscreen, for displaying information provided by the AID application 520. The touchscreen may also be used to receive input if it is a touchscreen. The user interface 523 may have input elements such as a keyboard, buttons, knobs, etc. In an operational embodiment, the user interface 523 may have a touchscreen display that is controllable by the processor 519 and operable to present a graphical user interface, the touchscreen display operable to present a graphical user interface related to the received input (sound or tactile) in response to the received input.

[0088] Still referring to Figure 5, the controller 504 may interface with a network such as a LAN or WAN, or a combination of the above networks providing one or more servers or cloud-based services 510 via the wireless communication link 598. The communication circuit 522, which may have transceivers 527 and 525, may be connected to the processor 519. The communication circuit 522 may be operated to transmit communication signals (e.g., command signals and control signals) to the wearable drug delivery device 502 and sample sensor 506, and to receive communication signals from the wearable drug delivery device 502 and sample sensor 506 (e.g., via transceiver 527 or 525). In one embodiment, the communication circuit 522 may have a first transceiver, such as reference number 525, which may be a Bluetooth® transceiver, and which is operable to communicate with the communication circuit 522 of the wearable drug delivery device 502, and a second transceiver, such as reference number 527, which may be a cellular transceiver, Bluetooth® transceiver, short-range wireless communication transceiver, or Wi-Fi® transceiver, and which is operable to communicate with the computing device 532 or the cloud-based service 510 via the network 508. Although two transceivers, 525 and 527, are shown, it is envisioned that the controller 504 may be equipped with transceivers such as cellular transceivers, Bluetooth® transceivers, short-range wireless communication transceivers, or Wi-Fi® transceivers.

[0089] Referring still to Figure 5, the cloud-based service 510 may be capable of storing user history information such as blood glucose measurements over a set period (e.g., days, months, years), drug delivery history including insulin delivery amounts (both basal and bolus doses) and insulin delivery times, the type of insulin delivered, indicated meal times, trends or deviations in blood glucose measurements or other user-related glucose treatment information, and specific factor settings including initial settings, current settings and past settings.

[0090] Referring still to Figure 5, other devices such as a smart accessory device 530 (e.g., a smartwatch), a fitness device 533, and other wearable devices 534 may be part of the drug delivery system 500. These devices may communicate with the wearable drug delivery device 502 to receive information and / or issue commands to the wearable drug delivery device 502. These devices 530, 533, and 534 may execute computer program instructions to perform some of the control functions otherwise performed by the processor 514 or processor 519. These devices 530, 533, and 534 may have a user interface such as a touchscreen display for displaying information such as current blood glucose levels, insulin load, delivery history, or other parameters or treatment-related information and / or received inputs. The display device may be operable to present a graphical user interface for providing inputs such as changes in basal insulin levels or requests for insulin bolus delivery. Devices 530, 533, and 534 also have wireless communication connection parts with sensor 506 and can directly receive not only blood glucose data but also other data such as user history data held by controller 504 and / or wearable drug delivery device 502.

[0091] Still referring to Figure 5, the user interface 523 can be a touchscreen display controlled by the processor 519, and the user interface 523 can be operated to present a graphical user interface that provides input of subjective insulin needs parameters available by the AID application 520. The processor 519 can present the graphical user interface on the user interface 523. Regarding other embodiments, graphical user interfaces of various embodiments can be shown. The AID application 520 can generate instructions for the pump 518 to deliver basal insulin to the user or the like.

[0092] Still referring to Figure 5, the processor 519 can also be operated to collect user-related physiological state data from sensors such as the sample sensor 506, or heart rate data from, for example, the fitness device 533 or the smart accessory device 530. In one embodiment, the processor 519, which executes the AID algorithm, can determine the amount of insulin to be delivered based on the user's collected physiological state and specific factors determined based on subjective insulin needs parameters. The processor 519 can output a control signal to the wearable drug delivery device 502 via one of the transceivers 525 or 527. The output signal can cause the processor 514 to send a command signal to the pump 518 to deliver an amount of insulin in the reservoir 511 to the user based on the output of the AID algorithm, corresponding to the determined dose. The processor 519 can also be operated to perform calculations regarding the settings of the AID algorithm, as described herein. Modifications to the AID algorithm settings provided via input, such as in the examples described herein, can be stored in memory 528.

[0093] Software implementations of the technologies described herein may include, but are not limited to, firmware, application-specific software, or any other type of computer-readable instruction that can be executed by one or more processors. Hardware implementations of the technologies described herein may include, but are not limited to, integrated circuits (ICs), application-specific integrated circuits (ASICs), field-programmable arrays (FPGAs), and / or programmable logic devices (PLDs). In some embodiments, the technologies described herein, and / or any systems or components described herein, may be implemented by a processor that executes computer-readable instructions stored on one or more memory components.

[0094] In addition or alternatively, while embodiments have been described with reference to closed-loop algorithm implementations, modified embodiments of the disclosed embodiments may be implemented to enable open-loop use. Open-loop implementations enable the use of various modes of insulin delivery, such as smart pens and syringes. For example, the disclosed AID applications and algorithms may be operable to perform various functions related to open-loop operation, such as generating prompts requesting input of information such as weight or age. Similarly, the AID application or algorithm may receive insulin doses from the user via a user interface. Other open-loop operations may also be performed by adjusting user settings, etc., in the AID application or algorithm.

[0095] Some embodiments of the disclosed apparatus may be implemented using a storage medium, computer-readable medium, or manufactured article, which, when performed by the apparatus (i.e., a processor or microcontroller), can store instructions or a set of instructions that can cause the apparatus to perform methods and / or operations in accordance with the embodiments of the Disclosure. Such a machine may have, for example, any suitable processing platform, computing platform, computing device, processing unit, computing system, processing system, computer, processor, etc., and may be implemented using any suitable combination of hardware and / or software. Computer-readable media or products include, for example, any suitable type of memory unit, memory article, memory product, memory medium, storage device, storage product, storage medium and / or storage unit, such as memory (including non-temporary memory), removable or non-removable media, erasable or non-writable media, writable or rewritable media, digital or analog media, hard disks, floppy disks, compact disc read-only memory (CD-ROM), compact disc recordable (CD-R), compact disc rewritable (CD-RW), optical discs, magnetic media, magneto-optical media, removable memory cards or discs, various types of digital multipurpose discs (DVDs), tapes, cassettes, etc. Instructions include any suitable type of code, such as source code, compiled code, interpreted code, executable code, static code, dynamic code, encrypted code, programming code, etc., and may be implemented using any suitable high-level, low-level, object-oriented, visual, compiled and / or interpreted programming language. Non-temporary computer-readable media manifesting programming code may generate processor activity when executing the programming code to perform functions such as those described herein.

[0096] Specific embodiments of this disclosure have been described above. However, this disclosure is not limited to those embodiments, and it is explicitly stated that additions and modifications of those expressly described herein are also intended to fall within the technical scope of the disclosed embodiments. Furthermore, it should be understood that the features of the various examples described herein are not mutually exclusive and may exist in various combinations and substitutions, even if such combinations or substitutions are not expressly described herein, without departing from the spirit and scope of the invention as defined in the appended claims. In fact, variations, modifications, and other implementations of the contents described herein will be made to those skilled in the art without departing from the scope of the invention as defined in the appended claims. Thus, the disclosed examples should not be defined solely by the preceding illustrative descriptions.

[0097] This summary of the disclosure is provided to allow readers to quickly grasp the nature of the technical disclosure. It should be understood that the summary is not used to interpret or limit the claims. In addition, in the preceding detailed description, various features are grouped into a single example to streamline the disclosure. This method of disclosure should not be interpreted as reflecting an intention that the claimed example requires more features than those specified in each claim. Rather, as reflected in the following claims, the subject matter of the invention is less than all the features of the disclosed single example. Therefore, the following claims are incorporated into the detailed description, and each claim stands on its own as a separate example. In the attached claims, the terms “including” and “in which” are used as English equivalents of “comprising” and “wherein,” respectively. Furthermore, terms such as “first,” “second,” and “third” are used merely as labels and are not intended to impose numerical requirements on their subjects.

[0098] The examples described above are presented for illustrative and explanatory purposes only. This disclosure is not intended to be limited to the exact form disclosed. Many modifications and variations are possible in light of this disclosure. The technical scope of this disclosure is not limited by this detailed description, but rather by the claims appended to this specification.

[0099] While the present invention is defined in the attached claims, it should be understood that the present invention may also be (alternatively) defined according to the following embodiments. 1. In a drug delivery device, the drug delivery device is: Drug delivery device and There are gaps between the individual rails of a set of rails, A detection element positioned adjacent to the gap between a pair of rails, An injection device is positioned adjacent to the gap between a set of rails and positioned to mirror the detection element, A biasing mechanism connected to a first sliding member, wherein the first sliding member is a biasing mechanism that is operable to move a cannula in a first direction along a set of rails and to move a sensing element in a second direction opposite to the first direction along the set of rails, A drug delivery device comprising an insertion funnel positioned on the opposite side of the set of rails, the insertion funnel having an insertion funnel inlet configured to allow the detection element to pass into the insertion funnel. 2. The drug delivery device in Embodiment 1, wherein the biasing mechanism is configured to rotate in a clockwise or counterclockwise direction. 3. The drug delivery device according to Embodiment 1, wherein the detection element is positioned within the insertion funnel inlet through the insertion funnel while the first sliding member is retracting. 4. The drug delivery device according to Embodiment 1, wherein the injection device has a fluid path that is fluidly connected to a liquid reservoir. 5. A drug delivery device according to Embodiment 4, wherein the liquid reservoir contains insulin. 6. The drug delivery device according to Embodiment 1, further comprising a catch block positioned on the rails of the set of rails, wherein the catch block is configured to fix the cannula sliding member in a predetermined position. 7. The drug delivery device according to Embodiment 1, wherein the detection element has a continuous glucose monitoring sensor. 8. The drug delivery device in Embodiment 2, wherein the perforating element of the injection device is inserted into the housing outlet when the needle / cannula is extended. 9. The drug delivery device according to Embodiment 1, wherein the insertion funnel has two angled surfaces that are opposite to each other. 10. The drug delivery device according to Embodiment 1, further comprising a trigger communicating with the biasing mechanism, wherein the trigger is configured to activate the biasing mechanism. 11. The drug delivery device according to Embodiment 1, wherein the first sliding member has a projection extending toward the gap between the pair of rails and is configured to be connected to the sensor sliding member. 12. The biasing mechanism, A drug delivery device according to Embodiment 1, further configured to extend the cannula from the housing and position the detection element (224) inside the insertion funnel inlet when the biasing mechanism is fully rotated. 13. In a drug delivery system, the drug delivery system is A housing, wherein the housing is The drug delivery device has a pump, An injection system connected to a pump, wherein the injection system is The first set of rails, The second set of rails, A first sliding member that is operable to move on a first set of rails, the first sliding member having a sensor, A second sliding member that is operable to move along the second set of rails, the second sliding member having a cannula connected to the pump, A drug delivery system comprising a housing, an injection system, the positioning element comprising a positioning element configured to move the first sliding member in a first direction guided by the first set of rails, and the second sliding member in a second direction guided by the second set of rails.

Claims

1. In the drug delivery system (100), The drug delivery system (100) is A housing (150) equipped with a drug delivery device (160), Equipped with an injection system (180), The injection system (180) is One set of rails (104A, 104B, 104C) A first sliding member (116) that is operable to move along the aforementioned set of rails, A second sliding member (124) that is operable to move along the aforementioned set of rails, It has positioning elements (108a, 108b, 109, 142), The drug delivery system (100) is characterized in that the positioning element is configured to move the first sliding member in a first direction (C) while being guided by the set of rails, and to move the second sliding member in a second direction (B) while being guided by the set of rails.

2. The drug delivery system according to claim 1, wherein the positioning element comprises a biasing mechanism (142), a first arm (108a), and a second arm (108b).

3. The drug delivery system according to claim 1, wherein the first sliding member (116) is a sensor sliding member connected to the detection element (112).

4. The drug delivery system according to claim 3, wherein the detection element has a continuous glucose monitoring sensor.

5. The drug delivery system according to claim 1, wherein the second sliding member is a cannula sliding member (124) fluidly connected to a fluid reservoir (168).

6. The drug delivery system according to claim 5, wherein the fluid reservoir (168) is located within the housing (150) and contains a liquid drug.

7. The drug delivery system according to claim 1, wherein the positioning element comprises a biasing mechanism, a first arm, and a second arm, and the biasing mechanism is operable to the first arm and the second arm to deploy a needle / cannula (136) connected to the first sliding member and a detection element connected to the second sliding member when triggered.

8. The drug delivery system according to claim 7, wherein the biasing mechanism is further operable to retract the needle from the needle / cannula (136) after the first sliding member is deployed and to retract the needle of the sensor device when the second sliding member is deployed.

9. In the drug delivery device (200), The drug delivery device (200) is Drug delivery device, There is a gap (205) between each individual rail in a pair of rails (204A, 204B), A detection element (224) positioned adjacent to the gap between the aforementioned set of rails, An injection device (220, 232) is positioned adjacent to the gap between the set of rails and positioned to mirror the detection element, A biasing mechanism (242) connected to a first sliding member (216), wherein the first sliding member (216) is operable to move the cannula (232) along the pair of rails in a first direction (M) and the sensing element along the pair of rails in a second direction (N) opposite to the first direction, and the biasing mechanism (242) A drug delivery device (200) comprising an insertion funnel (208) positioned on the opposite side from the set of rails, wherein the insertion funnel (208) has an insertion funnel inlet (254) configured to allow a detection element to pass into the insertion funnel (208).

10. The drug delivery device according to claim 9, wherein the biasing mechanism is configured to rotate in a clockwise or counterclockwise direction.

11. The drug delivery device according to claim 9, wherein the detection element (242) is positioned within the insertion funnel inlet (254) through the insertion funnel (208) while the first sliding member (216) is retracting.

12. The drug delivery device according to claim 9, wherein the injection device has a fluid path (214) that is fluidly connected to a liquid reservoir.

13. The drug delivery device according to claim 12, wherein the liquid reservoir contains insulin.

14. The drug delivery device according to claim 9, further comprising a catch block (132) positioned on the rail (104C) of the set of rails, wherein the catch block is configured to fix the first sliding member (216), which functions as a cannula sliding member, at a predetermined position.

15. The drug delivery device according to claim 9, wherein the detection element (224) has a continuous glucose monitoring sensor.

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