Insertion mechanisms for an infusion delivery device

Abstract

An insertion mechanism for a fluid delivery device includes a catheter hub having a catheter coupled thereto, a needle hub having a needle coupled thereto and positioned proximal of the catheter hub, and a drive arm having a first end attached to the needle hub and a second end including a pivot point such that the drive arm is configured to rotate in a first direction to cause the needle hub to push the catheter hub distally along a curved pathway to achieve insertion of the needle and the catheter into tissue at an angle relative to a surface of the tissue, and to rotate in a second direction opposite the first direction to cause the needle hub to move proximally along the curved pathway to achieve retraction of the needle from the catheter, where the curved pathway has a radius defined by a virtual pivot point.

Description

[0001] INSERTION MECHANISMS FOR AN INFUSION DELIVERY DEVICE

[0002] CROSS REFERENCE TO RELATED APPLICATION(S)

[0003] [1] This application claims priority to and the benefit of U.S. Provisional Application No. 63 / 670,021, filed July 11, 2024, the content of which is incorporated herein by reference in its entirety.

[0004] FIELD

[0005] [2] This disclosure relates to insertion mechanisms that are sufficiently designed to be a component of an infusion delivery device.

[0006] BACKGROUND

[0007] [3] An external ambulatory infusion pump is a medical device used to deliver medicament into a patient’s body in a controlled manner that is designed to be portable or wearable. There are many different types of infusion pumps, which are used for a variety of purposes and in a variety of environments. Some infusion pumps are capable of delivering medicament in small amounts and may be used to deliver nutrients or medications, such as insulin or other hormones, antibiotics, chemotherapy drugs, and pain relievers.

[0008] [4] Insulin pumps are a type of external ambulatory infusion pump that helps diabetic patients keep their blood glucose levels within target ranges based on individual need. Some insulin pumps include various hardware and firmware so that the diabetic patient can, for example, attach the pump to their bodies, carry an amount of insulin within a reservoir for multiple daily uses, and precisely deliver appropriate amounts of insulin to the patient continuously and / or on- demand.

[0009] [5] As the infusion pumps are worn on the body of the patient, their size and configuration can be important to make them easier to wear and more comfortable for the patient. There is still a need for compact infusion pumps.

[0010] SUMMARY

[0011] [6] The present disclosure relates to an insertion mechanism, including: a catheter hub having a catheter coupled thereto; a needle hub having a needle coupled thereto and positioned proximal of the catheter hub; and a drive arm having a first end attached to the needle hub and a second end including a pivot point such that the drive arm is configured to rotate in a first direction to cause the needle hub to push the catheter hub distally along a curved pathway to achieve insertion of the needle and the catheter into tissue at an angle relative to a surface of the tissue, and to rotate in a second direction opposite the first direction to cause the needle hub to move proximally along the curved pathway to achieve retraction of the needle from the catheter, wherein the curved pathway has a radius defined by a virtual pivot point.

[0012] [7] The present disclosure relates to an insertion mechanism, including: a catheter hub having a catheter coupled thereto; a needle hub having a needle coupled thereto and positioned proximal of the catheter hub; and a rotation subassembly including: a drive arm having a first end attached to the needle hub and a second end including a pivot point such that the drive arm is configured to move in a first direction to cause the needle hub to push the catheter hub distally to achieve insertion of the needle and the catheter into tissue at an angle relative to a surface of the tissue, and to move in a second direction opposite the first direction to cause the needle hub to move proximally to achieve retraction of the needle from the catheter; a gear assembly coupled to the drive arm and configured to move the drive arm in the first and second directions; and a spring configured to apply a force on the gear assembly to cause movement of the drive arm.

[0013] [8] The present disclosure relates to an infusion delivery device, including: a reservoir for holding medicament; a plunger assembly to expel the medicament from the reservoir; a motor to drive the plunger assembly; a power source for the motor; an outlet; and an insertion mechanism, including: a torsion spring; a needle hub configured to carry a needle, wherein the needle hub is constrained to moving along a linear direction: a catheter hub configured to carry a catheter, wherein the catheter hub is configured to be constrained by the needle hub; and a drive arm coupled to the torsion spring at a first end of the drive arm and coupled to the needle hub at a second end of the drive arm, wherein: actuation of the torsion spring is configured to rotate the first end of the drive arm in a first direction; and rotation of the drive arm in the first direction is configured to move the needle hub in the linear direction toward the outlet and to move the needle hub in the linear direction away from the outlet.

[0014] [9] The present disclosure relates to an insertion mechanism, including: a catheter hub having a catheter coupled thereto; a needle hub having a needle coupled thereto and positioned proximal of the catheter hub; a drive arm configured to actuate the needle hub and the catheter hub; and a drive mechanism configured to drive the drive arm to move in a first direction to cause the needle hub to push the catheter hub distally to achieve insertion of the needle and the catheter into tissue at an angle relative to a surface of the tissue, and to move the drive arm in a second direction opposite the first direction to cause the needle hub to move proximally to achieve retraction of the needle from the catheter.

[0015] BRIEF DESCRIPTION OF THE DRAWINGS

[0016]

[0010] The following presently disclosed embodiments will be further explained with reference to the attached drawings, wherein like structures are referred to by like numerals throughout the several views. The drawings shown are not necessarily to scale, with emphasis instead generally being placed upon illustrating the principles of the presently disclosed embodiments.

[0017]

[0011] FIG. 1 is a perspective view of an example infusion delivery system that includes an infusion delivery device (IDD) and a remote controller device, according to one or more embodiments herein;

[0018]

[0012] FIG. 2 is an exemplary embodiment of a bottom view of an infusion delivery device (IDD), such as the IDD of FIG. 1 , according to one or more embodiments herein;

[0019]

[0013] FIG. 3 is a block diagram of various components of an infusion delivery device (IDD), such as the IDD of FIG. 1 , according to one or more embodiments herein;

[0020]

[0014] FIG. 4 is a block diagram of various components of an insertion mechanism of the present disclosure, according to one or more embodiments herein;

[0021]

[0015] FIG. 5 is a perspective view of an embodiment of an insertion mechanism sufficiently designed to be a component of an infusion delivery device of the present disclosure, according to one or more embodiments herein;

[0022]

[0016] FIG. 6A is a perspective view of portions of a needle support assembly of an insertion mechanism of the present disclosure, according to one or more embodiments herein;

[0023]

[0017] FIG. 6B is a side view of portions of the needle support assembly of an insertion mechanism of the present disclosure showing an embodiment of a drive arm, according to one or more embodiments herein;

[0024]

[0018] FIG. 7 is a close-up perspective view of components of a needle support subassembly of an insertion mechanism of the present disclosure, according to one or more embodiments herein;

[0025]

[0019] FIG. 8 is an exploded view of an exemplary embodiment of a needle hub, a catheter hub, a catheter, and a needle of the needle support subassembly of FIG. 7, according to one or more embodiments herein;

[0026]

[0020] FIG. 9 A and 9B illustrate how the needle hub of FIG. 7 is positioned to move within the curved slot of the needle support subassembly, according to one or more embodiments herein;

[0027]

[0021] FIGS. 10A, 10B, IOC, 10D, and 10E illustrate an exemplary embodiment of the progression of the needle hub and the catheter hub of FIG. 7 moving along the curved slot to introduce the catheter and needle out of the outlet bushing, according to one or more embodiments herein;

[0028]

[0022] FIGS. 11 A, 1 IB, and 11C illustrate an exemplary embodiment of a latching feature capable of interacting with a boss on the catheter hub of any of the insertion mechanisms of the present disclosure, according to one or more embodiments herein;

[0029]

[0023] FIGS. 12A, 12B, and 12C illustrate how a drive arm sufficiently designed to engage a rotation subassembly of any of the insertion mechanisms of the present disclosure interacts with a needle hub, according to one or more embodiments herein;

[0030]

[0024] FIG. 13A illustrates an exemplary embodiment of a component for preventing movement of a needle hub / catheter hub of any of the insertion mechanisms of the present disclosure until the insertion mechanism is ready to fire, according to one or more embodiments herein;

[0031]

[0025] FIG. 13B illustrates another exemplary embodiment of a component for preventing movement of a needle hub / catheter hub of any of the insertion mechanisms of the present disclosure until the insertion mechanism is ready to fire, according to one or more embodiments herein;

[0032]

[0026] FIG. 13C illustrates another exemplary embodiment of a component for preventing movement of a needle hub / catheter hub of any of the insertion mechanisms of the present disclosure until the insertion mechanism is ready to fire, according to one or more embodiments herein;

[0033]

[0027] FIG. 14 is a side view of portions of an embodiment of a rotation subassembly for use with an insertion mechanism of the present disclosure, according to one or more embodiments herein;

[0034]

[0028] FIGS. 15 A, 15B, and 15C illustrate an exemplary embodiment of components of a rotation subassembly and a needle support subassembly of the insertion mechanism of the present disclosure, according to one or more embodiments herein;

[0035]

[0029] FIGS. 16A, 16B, 16C, and 16D illustrate an exemplary embodiment of the motion of the drive arm of an insertion mechanism of the present disclosure relative to the curved slot as the shaft and the gears rotate to move the drive arm which in turn move the needle and catheter hubs along the curved slot, according to one or more embodiments herein;

[0036]

[0030] FIG. 17 is a perspective view of an embodiment of portions of a rotation subassembly of an insertion mechanism of the present disclosure where a torsion spring’s rotation translates through spur gears to power the rotation of a shaft with two partial bevel gears that would then connect with a drive arm of any of the insertion mechanisms of the present disclosure, according to one or more embodiments herein;

[0037]

[0031] FIGS. 18A, 18B and 18C are perspective views of an embodiment of an insertion mechanism sufficiently designed for use in an infusion delivery device of the present disclosure, according to one or more embodiments herein;

[0038]

[0032] FIGS. 19 A, 19B, 19C and 19D illustrate various views of components of a rotation subassembly of the insertion mechanism illustrated in FIG. 18 A, according to one or more embodiments herein;

[0039]

[0033] FIGS. 20A, 20B, and 20C illustrate how, during activation, the gear stacks turn the drive arm of FIG. 19A which in turn connects with the needle hub to drive the needle and catheter, according to one or more embodiments herein;

[0040]

[0034] FIG. 21 A and FIG. 21 B show an embodiment of some of the inner components of an infusion delivery device of the present disclosure including an embodiment of an insertion mechanism, according to one or more embodiments herein;

[0041]

[0035] FIG. 22A and FIG. 22B show an embodiment of some of the inner components of an infusion delivery device of the present disclosure including an embodiment of an insertion mechanism, according to one or more embodiments herein;

[0042]

[0036] FIG. 23A and FIG. 23B show an embodiment of some of the inner components of an infusion delivery device of the present disclosure including an embodiment of an insertion mechanism, according to one or more embodiments herein;

[0043]

[0037] FIG. 24A depicts a perspective view of an insertion mechanism, according to one or more embodiments herein;

[0044]

[0038] FIG. 24B depicts a top perspective view of partial components of the needle support assembly and the rotation subassembly of the insertion mechanism of FIG. 24A, according to one or more embodiments herein;

[0045]

[0039] FIG. 25A depicts a top perspective view of the insertion mechanism of FIG. 24A in a pre- deployed configuration, according to one or more embodiments herein;

[0046]

[0040] FIG. 25B depicts a side perspective view of partial components of the insertion mechanism of FIG. 24A in a pre-deployed configuration, according to one or more embodiments herein;

[0047]

[0041] FIG. 26 depicts a top perspective view of the insertion mechanism of FIG. 24A at a first time during deployment, according to one or more embodiments herein;

[0048]

[0042] FIG. 27A depicts a top perspective view of the insertion mechanism of FIG. 24A at a second time during deployment, according to one or more embodiments herein;

[0049]

[0043] FIG. 27B depicts a side perspective view of partial components of the insertion mechanism of FIG. 24A at the second time during deployment, according to one or more embodiments herein;

[0050]

[0044] FIG. 27C depicts a perspective view of partial components of the insertion mechanism of FIG. 24A at the second time during deployment, according to one or more embodiments herein;

[0051]

[0045] FIG. 28 depicts a top perspective view of partial components of the insertion mechanism of FIG. 24 A at a third time during deployment, according to one or more embodiments herein;

[0052]

[0046] FIG. 29 depicts a top perspective view of partial components of the insertion mechanism of FIG. 24A post deployment, according to one or more embodiments herein;

[0053]

[0047] FIG. 30 depicts a top transparent view of an IDD having an insertion mechanism therein, according to one or more embodiments herein;

[0054]

[0048] FIG. 31 depicts a top view of an IDD having an insertion mechanism therein, according to one or more embodiments herein; and

[0055]

[0049] FIG. 32 depicts a top view of an IDD having an insertion mechanism therein, according to one or more embodiments herein.

[0056]

[0050] While the above-identified drawings set forth presently disclosed embodiments, other embodiments are also contemplated, as noted in the following disclosure. This disclosure presents illustrative embodiments by way of representation and not limitation. Numerous other modifications and embodiments can be devised by those skilled in the art which fall within the scope and spirit of the principles of the presently disclosed embodiments.

[0057] DETAILED DESCRIPTION

[0051] The present disclosure provides various embodiments of insertion mechanisms that are sufficiently designed to be a component of an infusion delivery device (TDD) that is operated to insert a concentric needle and catheter to a specified depth in a user's tissue to establish a fluid path from a fluid reservoir contained within the IDD. An insertion mechanism as described has one more or advantages, such as, for example, (1) a straight needle is elastically bent into an arc path within the device to provide an angled insertion and retraction motion with minimal curvature into tissue, and (2) the insertion and retraction motions are powered by one actuator. In some embodiments, an insertion mechanism of the present disclosure can be used to reduce the size of an IDD for wearability and comfort of the user when the IDD is worn on the skin of the user.

[0058]

[0052] The example embodiments of the present disclosure are described with reference to an example infusion delivery device, such as an IDD 10, as shown in FIG. 1. The IDD 10 can be any type of medical device configured to deliver any type of medicament or other fluid to the patient. In some embodiments, the medicament can comprise insulin or other pharmaceutical or therapeutic drugs. In some embodiments, the IDD 10 is a wearable infusion pump. In some embodiments, the IDD 10 is an insulin patch pump. The IDD 10 can be programmable and / or can be optionally controlled by a remote controller (RC) 11, such as a mobile phone, dedicated wireless remote controller (WC), or other control device. In some embodiments, the IDD 10 can be capable of wirelessly communicating with the RC 11. In some embodiments, the IDD 10 can include a wired controller rather than communicating with a controller remotely.

[0059]

[0053] In some embodiments, the IDD 10 includes a housing comprising a top enclosure 12 and a bottom enclosure 14. As is described in more detail below, the IDD 10 houses within the housing a reservoir for holding a medicament and an insertion mechanism which, upon activation, is used to insert a catheter into the user’s skin to establish a fluid path from the reservoir in the IDD to the user. The IDD 10 can also include an adhesive patch 16 to attach the IDD 10 to the skin of the patient.

[0060]

[0054] FIG. 2 provides an exemplary embodiment of a bottom view of an IDD 10 of the present disclosure. In some embodiments, an adhesive patch having liner 16 includes an opening 17a to expose a fill port 4 on the bottom of the IDD 10 that provides access to an inlet port of an internal reservoir, as discussed below. In some embodiments, an indicia 29 may be included on the adhesive patch liner to help the user to locate the fill port 4. The adhesive patch and liner 16 include an opening 17b to expose an insertion opening 19 in the bottom enclosure 14 such that a catheter can extend from the bottom surface of the IDD 10 and be inserted into the skin of the patient to deliver medicament from the reservoir to the patient, as will be explained in more detail below. The adhesive patch and liner 16 can also include another hole 17c to provide access to a power button 6, which may be indicated to a user by a power button indicia 7. The button 6 can be depressed by the user when the user is ready to turn on the IDD 10 and / or pair the IDD 10 with an RC.

[0061]

[0055] FIG. 3 is a block diagram of various example components of an IDD 10 of the present disclosure. The IDD 10 includes inside the housing a reservoir 24 for holding medicament, a plunger assembly 25 to expel the medicament from the reservoir 24, a motor 23 to drive the plunger assembly 25, and a power source 21, such as a battery, to provide power to the motor 23. The insertion mechanism 22 is also positioned within the housing and is used to insert a needle concentrically disposed in a catheter to a specified depth in tissue, and then remove the needle, leaving the catheter behind. The catheter of the insertion mechanism 22 is fluidly connected to the reservoir 24 to deliver the medicament from the reservoir 24 to the patient. The insertion mechanism 22 can be sized and shaped to minimize the size of the IDD. In some embodiments, the insertion mechanism 22 is positioned entirely within the housing. In some embodiments, the insertion mechanism 22 is positioned parallel to the reservoir. As will be described below, the insertion mechanism 22 is designed to move a needle, which is initially positioned inside the insertion mechanism 22 with a curved or bent shape, in a curved path such that a distal end of the needle is inserted at an angle relative to the surface of the skin of the patient. In some embodiments, the needle is configured to be inserted into the surface of the skin at an angle of approximately 55 degrees. In some embodiments, the needle is configured to be inserted into the surface of the skin at an angle of approximately 45 degrees. In some embodiments, the needle is configured to be inserted into the surface of the skin at an angle in the range of 30 degrees to 60 degrees.

[0062]

[0056] In some embodiments, an activation mechanism may be provided to activate the insertion mechanism 22. In some embodiments, the activation mechanism is an automatic activation mechanism that is positioned inside the IDD. For example, an automatic activation mechanism that is positioned fully within the IDD can be triggered electronically though a wireless controller or some other wireless means. In some embodiments, the activation mechanism is a manual activation mechanism that is accessible via the outside of the IDD, such as a button on the outside of the IDD.

[0063]

[0057] FIG. 4 is a block diagram of various components of an insertion mechanism of the present disclosure. In an embodiment, an insertion mechanism of the present disclosure includes two subassemblies: a needle support subassembly that comprises a needle hub, a needle, a catheter hub, a catheter, and a support frame having a curved slot such that the needle and catheter hubs are received in the curve slot and slidable along a path of the curved slot; and a rotation subassembly coupled to the needle support subassembly to provide the components necessary to move the needle and catheter hubs through the path of the curved slot of the needle support subassembly so as to insert and retract the needle in a single, uninterrupted motion. In general, in some embodiments, the rotation subassembly includes a drive arm, a gear system coupled to the drive arm, and either a torsion or compression spring that drives the gear system. Various embodiments of needle support subassemblies are provided herein, as discussed and illustrated with respect to FIG. 6A, FIG. 7, FIG. 15 A, and FIG. 18A. Various embodiments of rotation subassemblies are provided herein, as discussed and illustrated with respect to FIG. 14, FIG. 15 A, FIG. 17 and FIG. 19A.

[0064]

[0058] FIG. 5 shows an exemplary embodiment of an insertion mechanism 22 that is sufficiently designed to be a component of an IDD. The insertion mechanism 22 includes two main subassemblies: a needle support subassembly 26 that holds the needle and catheter, and a rotation subassembly 27 coupled to the needle support subassembly 26 to move the needle and catheter through the needle support subassembly 26.

[0065]

[0059] As shown in FIG. 6A, needle support subassembly 26 comprises a needle hub 28 having a top 229 and a base 230, a needle 28a, a catheter hub 34, a catheter 34a, and a support frame 35 having a curved slot 30 such that the needle and catheter hubs are received in the curve slot 30 and slidable along a path of the curved slot 30. In some embodiments, the needle and catheter exit the insertion mechanism 22 at an outlet bushing 36. The outlet bushing 36 is configured to provide a seal on the insertion path and enforce the path of the needle. The needle 28a and the catheter 34a straighten out after exiting the outlet bushing 36 for an angled insertion in the tissue surface. In an embodiment, when an IDD is applied to the patient’s skin, the outlet bushing 36 is set away from the tissue such that even when retracted, the needle 28a still passes through the outlet bushing 36. The outlet bushing 36 creates a seal around the outer diameter of the catheter 34a by compressing it. The needle 28a needs to be within the catheter 34a at the point of compression so that the seal is properly formed, to prevent the catheter 34a from collapsing and not forming a proper seal. This can also prevent the risk of the needle 28a losing its arc and cutting through the catheter 34a material.

[0066]

[0060] FIG. 6B shows some of the components of FIG. 6 A, now with a rotating drive arm 40 visible that engages with the pin 46. As shown in FIG. 6B, the force to move the needle hub 28 and catheter hub 34 along the pathway of the curved slot (not visible) to insert the needle 28a in tissue is provided by the rotating drive arm 40. In some embodiments, the drive arm 40 connects to the needle hub base 230 via pin 46. The drive arm 40 is connected to the base 230 of the needle hub 28 at a first end 40a of the arm, and the drive arm 40 moves about a separate pivot point 42 located at a second end 40b of the drive arm. The drive arm 40 is configured to rotate in a first direction to achieve insertion of the needle and the catheter, and to rotate in a second direction opposite the first direction. This reversal of motion between the first direction and second direction retracts the needle hub 28. In some embodiments, the drive arm 40 is configured to rotate in a single direction, with the drive arm 40 moving in a first linear direction during a stroke of the first half of the rotation of the drive arm 40, and the drive arm 40 moving in a second linear direction opposite the first linear direction during a stroke of the second half of the rotation of the drive arm 40. In some embodiments, the needle hub 28 is connected to the drive arm 40 via a slot 44. The slot 44 is used to account for differences in the axis of rotation of the drive arm.

[0067]

[0061] FIG. 7 is a close-up perspective view of an embodiment of components of a needle support subassembly of an insertion mechanism of the present disclosure. The needle support subassembly includes, for example, a needle hub 28 having a back face 231, a top 229, and a base 230, a catheter hub 34, a needle 28a and a catheter 34a in a bent, undeployed position. The needle 28a is configured to be bent around the needle hub 28, and then pass through the catheter hub 34 before entering the catheter 34a. The bend of the needle 28a and the catheter 34a is enforced by the outlet bushing 36 on one end, and the needle and catheter hubs on the other end. In this embodiment, the catheter hub 34 is nested within a front portion of the needle hub 28. The needle hub 28 is shaped to constrain the catheter hub 34 such that the catheter hub 34 is pushed along the pathway of the curved slot 30 by the needle hub 28 during insertion of the catheter 34a and needle 28a into tissue. As the needle 28a is attached to the needle hub 28 and the catheter 34a is attached to the catheter hub 34, the catheter 34a can be left behind in the tissue when the needle hub 28 and the needle 28a are retracted back into the IDD.

[0068]

[0062] FIG. 8 shows an exploded unassembled view of an embodiment of a needle hub 28, a catheter hub 34, a needle 28a and a catheter 34a, as shown in FIG. 7. The needle hub 28 has a front side 232 and a back side 233. As shown, the needle 28a is attached to the needle hub 28, which is positioned proximal of the catheter hub 34. The needle 28a is positioned to pass through the catheter hub 34 such that a distal portion of the needle 28a is inserted into the catheter 34a. Both the catheter 34a and the needle 28a pass through the outlet bushing 36.

[0069]

[0063] FIG. 9A illustrates a back view of the needle hub 28 alone showing pins 8 and 9 that ride in the curved slot 30. FIG. 9B illustrates an opposite view of the needle hub 28 and curved slot 30. The position of the hidden pins side is shown as a dashed line in FIG. 9B. As the pins 8 and 9 slide along the curved slot 30, the needle hub 28 rotates around a virtual pivot point, described in more detail below with respect to FIGS. 12A-12C. The pins are connected with material in this embodiment for rigidity, though the brace material is narrower so that only the pins constrain movement. The needle hub 28 travels along the curved pathway formed by the curved slot 30 as the needle is inserted. The bend is enforced by the position of the hub and the outlet bushing. The needle 28a is the most deformed before and after firing. As the needle 28a travels, the portion of the needle 28a that is pushed beyond the outlet bushing is able to relax and straighten. The curved motion of the needle hub 28 and catheter hub 34 through the curved slot 30 thus moves the needle 28a and the catheter 34a through the same curvature. The needle 28a begins bent within the IDD, and the motion carries the needle 28a along the bend path toward the outlet bushing, where it straightens out for an angled insertion into tissue. A needle support subassembly of the present disclosure is configured to provide a curved pathway for the needle and catheter to travel for insertion into tissue. The path of insertion of the needle and the catheter is dictated by the needle hub 28 to which the needle is attached and the curved slot 30 formed in a support 35 of the needle support subassembly 26. In an embodiment, such as that shown in FIG. 6A, the support 35 is in the form of a substantially flat plate with an extension positioned at the top of the plate to support the needle hub 28 and the catheter hub 34 before insertion of the needle and catheter. In another embodiment, such as that nest shown in FIG. 21 A, the support is a different shape.

[0070]

[0064] FIGS. 10A, 10B, 10C, 10D, and 10E illustrate the progression of the needle hub 28 and the catheter hub 34 as the needle 28a and catheter 34a move along the curved slot 30 and are deployed, and then the needle 28a is retracted back into the insertion mechanism. As shown in FIG. 10A, the needle hub 28 is configured to sit proximal of the catheter hub 34. In some embodiments, the needle hub 28 is sized and shaped such that the catheter hub 34 is held by the needle hub 28. As shown, the catheter hub 34 is loosely constrained by the needle hub 28 such that if the needle hub 28 moves forward in a distal direction, as shown in FIG. 10B, the needle hub 28 pushes the catheter hub 34 forward as well. Note that as the needle 28a and catheter 34a are moved forward, the portion of the needle 28a and catheter 34a that extend beyond the outlet bushing 36 are no longer constrained into a bend, and therefore deploy straight at the specified insertion angle (for example, 55°). In an embodiment, upon extending the catheter 34a to full length, the catheter hub 34 snaps into a latching mechanism 37, which will be explained in more detail below, preventing the catheter hub from reversing its position, as shown in FIG. 10C. As explained above, the catheter hub 34 is only constrained by the needle hub 28 in order to be pushed in the forward direction. As there is no mechanical connection between the catheter hub 34 and the needle hub 28, the needle hub 28 can retract from the catheter hub 34 and back towards its original position, as shown in FIGS. 10D and 10E, leaving the catheter 34a and catheter hub 34 in the deployed position.

[0071]

[0065] Referring to FIGS. 11A, 1 IB, and 11C, in some embodiments, the catheter hub 34 can include a boss 39 that engages with a latching feature 37 to lock the catheter in position after insertion, so when the needle hub 28 is retracted, the catheter stays inserted in tissue. As shown in FIGS. 11A-11C, in some embodiments, the latching feature 37 is in the form of a tab 38 positioned near the bottom of the deployment arc of the curved slot. The tab 38 includes a cutout 239 that is configured to engage with the boss 39 on the catheter hub. When deploying, the catheter hub 34 deflects the tab 38 until the boss 39 seats within the cutout 239 of the tab 38, at which point the tab 38 rebounds up, locking the catheter hub 34 in place. It will be understood that any latching mechanism can be used to prevent any reverse movement of the catheter hub after full deployment have been achieved.

[0072]

[0066] FIGS. 12A, 12B, and 12C illustrate the pin side of needle hub 28, which in this embodiment is on the back side of the needle hub 28 (as opposed to being on the front side of the needle hub 28 in FIG. 6B), the virtual pivot track, and the drive arm 40. To keep a compact profile while maximizing needle bend radius, a virtual pivot 41 is used to enforce the insertion arc. The arc of rotation of the needle hub, catheter hub, needle, and catheter is defined not by a physical pivot point to which these components are attached, but rather a virtual pivot point 41, shown in FIGS. 12A-12C. This virtual pivot point is not physically attached to any of the components but is used to determine the radius of the curved slot 30 through which the needle hub and catheter hub move. This allows for a larger needle bend radius within the IDD, which leads to less deformation and resulting curvature of the needle as it penetrates the tissue. By using a curved slot to enforce the curved path that the needle and catheter travel through the insertion mechanism, rather than attaching the needle hub directly to a physical pivot point, the radius of curvature of the path of the needle hub and catheter hub can be much larger and still fit within the IDD. A large radius of curvature can be used to ensure that the needle does not experience significant plastic deformation, as this could lead to a substantial arc in the needle and catheter within the tissue. The pin 46, shown in FIGS. 12A-12C and 9A-9B, on the needle hub 28 is configured to be positioned in the slot 44 such that a mechanical linkage is formed between the needle hub 28 and the drive arm 40, so that the rotary motion of the drive arm 40 causes the movement of the needle hub along the curved path along the curved slot 30. The placement of the arm pivot is selected to minimize off-axis pushing of the needle hub when force during insertion is highest.

[0073]

[0067] Thus, the needle hub is constrained to the virtual pivot track, which constrains the hub to rotate about the virtual pivot point. In some embodiments, the needle hub has a drive pin, which is pushed by the arm. Therefore, the relative distance between the point of contact (for example, the drive pin) on the needle hub and the axis of the drive arm changes throughout deployment. The slot accounts for this change in relative distance, allowing the pin to be pushed through the full deployment arc.

[0074]

[0068] Various locking methods can be utilized to prevent movement of the components of the insertion mechanism before activation of the insertion mechanism, for example, as a safety feature. Otherwise, a spring used to activate the insertion mechanism would immediately apply a force and fire the insertion mechanism after assembly because the spring begins in a compressed state. Either automatically, or through manual pushing, the component can be moved out of the way to allow rotation and therefore firing. In some embodiments, as shown in FIG. 13 A, the insertion mechanism can include a trigger 31 configured to activate the insertion mechanism. The trigger is positioned such that it can block movement of the insertion mechanism, for example, by keeping the spring compressed. Moving the trigger out of the way allows the spring to move to cause movement of the drive arm 40. In some embodiments, the trigger can be automatically moved (i.e., pulled with a shape memory wire or a solenoid). In some embodiments, the trigger can be manually moved (i.e., with a membrane button on the top enclosure, similar to the power button on the bottom enclosure). Either way, when the trigger moves, the insertion mechanism is released and is able to go through its full movement.

[0075]

[0069] For instance, referring to FIG. 13B, an example embodiment of a shape memory wire to move a trigger is depicted. A trigger 31 is depicted with a first end 242, a second end 244, and a pivot point 246. A shape memory wire 250 can be coupled to the trigger 31 at the second end 244 of the trigger 31. The shape memory wire 250 can have a known, baseline shape. The known, or baseline, shape can be a first length. During assembly, the shape memory wire 250 can be strained into a deformed shape. In some embodiments, the shape memory wire 250 can be stretched into the deformed shape. In some embodiments, the deformed shape can be a second length greater than the first length. With the shape memory wire 250 in the deformed shape, the trigger 31 can be in an initial position Pl, shown in dashed line in FIG. 13B. In the initial position Pl , the first end 242 of the trigger 31 abuts the catheter hub 34. Therefore, the trigger 31 can block movement of the insertion mechanism, for example, by keeping the activation spring compressed. In some embodiments, the shape memory wire 250 can be heated to an inflection temperature, causing the shape memory wire 250 to transition from the deformed shape to the known, baseline shape. Such transition can include the shape memory wire 250 shortening in length. In some embodiments, the shape memory wire 250 is heated to its inflection temperature through joule heating. For instance, current can be run through the shape memory wire 250 to heat the shape memory wire 250 to its inflection temperature. As the shape memory wire 250 transitions to its known, baseline shape (e.g., reduces in length), it can apply a downward force on the second end 244 of the trigger 31. The downward force can cause the trigger 31 to pivot about the pivot point 246. Therefore, as the second end 244 of the trigger 31 lowers, the first end 242 of the trigger 31 can raise. The force applied by the shape memory wire 250 to the trigger 31 can cause the trigger 31 to assume the second position P2 shown in FIG. 13B. In the second position P2, the first end 242 of the trigger 31 is out of contact with the catheter hub 34. Moving the trigger 31 into the second position P2 allows the spring to move to cause movement of the drive arm 40. In some embodiments, the shape memory wire can be a nitinol wire, for instance, that could be used to activate the trigger 31.

[0070] In some embodiments, the shape memory wire 250 can be used for a one-time use activation of an insertion mechanism 22 for needle and / or catheter deployment. In some embodiments, the shape memory wire 250 can maintain its deformed shape under load (e.g., under force from the spring) until the shape memory wire 250 is heated to its inflection temperature. In some embodiments, the shape memory wire can be deformed (e.g., elongated) and remain in the deformed, or elongated, shape without a continuously applied load, meaning that the shape memory wire 250 can be initially deformed to hold a set shape and then electrically activated to return to the known shape. In some embodiments, when the shape memory wire 250 is heated to the inflection temperature, the force generated during the mechanical transition of the wire can be utilized to fuse and break the wire by design in such a way that the previously-held loaded mechanism (e.g., the spring loaded needle and catheter hubs) is allowed to travel freely.

[0076]

[0071] The electrical and mechanical fundamentals of shape-memory alloys require a specific balance to generate the shape-memory-return cycle with enough force given a short time window. Larger diameter wires can generate more force when returning to the known shape but require more power to generate enough heat to reach the inflection temperature. Conversely, smaller diameter wire generates less force during the shape-memory return cycle but can be heated and activated much faster. Power consumption of the mechanism can be minimized while force generation can be maximized. In some embodiments, the shape memory wire 250 can have a diameter of roughly 0.1 mm. In some embodiments, the shape memory wire 250 can enable rapid deployment of the needle and catheter. In some embodiments, the inflection temperature of the shape memory wire 250 is selected such that the mechanism will only deploy when desired, and avoids premature deployment through many factors, including the shape memory material’s elongation characteristics, ability to remain deformed with and without an applied load, and high- temperature activation, or inflection, requirements that are higher than any foreseen ambient temperatures.

[0077]

[0072] Referring to FIG. 13C, another embodiment of a shape memory wire to move a trigger is depicted. In some embodiments, the trigger 31 can include an arm 31a. In some embodiments, the shape memory wire 250 can be looped around the trigger 31. In some embodiments, the shape memory wire 250 can be looped around the arm 31a. FIG. 13C shows the shape memory wire 250 in the deformed shape, with the trigger 31 in an initial position, in which the first end 242 of the trigger 31 abuts the catheter hub 34. Therefore, the trigger 31 can block movement of the insertion mechanism, for example, by keeping the activation spring compressed. As discussed above, the shape memory wire 250 can be heated to the inflection temperature, causing the shape memory wire 250 to transition from the deformed shape to the known, baseline shape. Such transition can include the shape memory wire 250 shortening in length. As the shape memory wire 250 transitions to its known, baseline shape (e.g., reduces in length), it can apply a force on the trigger 31. The force can cause the trigger 31 to pivot about the pivot point 246, raising the first end 242 of the trigger 31 such that the first end 242 of the trigger 31 is out of contact with the catheter hub 34. Therefore, the spring is allowed to move to cause movement of the drive arm 40.

[0078]

[0073] FIG. 13B and FIG. 13C merely shows two examples of an embodiment including a shape memory wire to move a trigger. The shape memory wire can be attached to the trigger anywhere along the trigger, such that a change in shape of the wire (e.g., shortening or lengthening) applies a force (e.g., a pushing, pulling, or rotation) on the trigger to move the trigger out of contact with one or more components of the insertion mechanism to allow the catheter and needle to be deployed. Embodiments can include, but are not limited to, a lever that pulls a trigger feature away around a pivot point, a shape-memory wire that pulls a blocking feature of a trigger out of the way, a wire that exceeds its strain maximum and fuses / breaks to release the mechanism (i.e. fuse wire), a shape-memory alloy that unlocks / moves / rotates a locking feature of a trigger, etc. In any embodiments, an electrical circuit can be completed by the wire. Therefore, embodiments, can utilize a looped wire that wraps around the lever arm. In some embodiments, the need for a looped wire can be alleviated if additional conductive elements exist to complete the circuit.

[0079]

[0074] As explained above, for example, in reference to FIG. 5, to rotate the drive arm 40, the insertion mechanism 22 can utilize a rotation subassembly, which can include the drive arm 40, a gear system 51 coupled to the drive arm 40, and an actuator, such as a spring 50, that drives the gear system 51. To reduce the required stroke of the actuator and to allow for reversing the direction of needle movement, a single gear system is used to rotate the drive arm in both forward and reverse directions. The ability of the rotation subassembly to reverse its own direction results in only needing a single source of actuation. Additionally, the reduced stroke size means that the volume taken up by the mechanism is significantly reduced relative to other solutions, allowing for a reduction in overall wearable device size.

[0075] FIG. 14 illustrates portions of an embodiment of the rotation subassembly 27 including a rack support 54, which includes an upper rack 56 and a lower rack 58. The upper rack 56 and lower rack 58 are configured to engage with a pinion 60 positioned on a shaft 62. The pinion 60 is located on the rack support 54 between the upper rack 56 and the lower rack 58. The upper and lower racks are positioned on the rack support 54 in a sequential opposed configuration such that movement of the rack support 54 allows the pinion 60 to first engage with the upper rack 56 and then engage with the opposed lower rack 58. Thus, motion in the direction of arrow A of the rack support 54 allows the pinion 60 to engage each of the upper and lower racks separately and in sequence.

[0080]

[0076] The pinion 60 is configured to couple to a drive arm (for example drive arm 40 in FIG. 6B) via the shaft 62 such that the motion of the pinion 60 relative to the upper and lower racks causes the drive arm 40 to rotate. As shown, the pivot point 42 of the drive arm 40 is on a shaft 62 that passes through the pinion 60. As the upper and lower racks are opposed to one another, the motion of the pinion 60 relative to the upper rack 56 causes rotation of the drive arm 40 in the first direction to achieve insertion of the needle and the catheter insertion, and motion of the pinion 60 relative to the lower rack 58 causes rotation of the drive arm 40 in the second direction to achieve removal of the needle. In particular, when the pinion 60 is engaged with the upper rack 56, the movement of the rack support causes the pinion and the drive arm to move counterclockwise to advance the needle hub for insertion, while when the pinion 60 is engaged with the lower rack 58, the movement of the rack support causes the pinion and the drive arm to move clockwise to retract the needle hub.

[0081]

[0077] In operation, upon deployment of the compression spring 50, the upper rack 56 is configured to engage with the pinion 60 concentrically attached to the drive arm 40, rotating it to insertion. After insertion of the needle, the continued motion of the spring 50 can push the first upper rack 56 further along to cause the first upper rack 56 to disengage from the pinion. Continued motion of the spring 50 then allows the lower rack 58 on the opposite side of the gear to engage the pinion 60 to provide reversed rotation on the pinion 60 to remove the needle 28a. As the radius of the pinion 60 is smaller than where the drive arm 40 contacts the needle hub 28, a shorter amount of travel by the rack and pinion can be converted to a relatively larger travel in the needle hub 28, reducing the amount of space required to actuate the needle 28a from within the IDD to the specified tissue depth and back.

[0078] In reference to FIG. 14, in some embodiments of the rotation subassembly 27, both directions of motion of the drive arm are driven by a single spring through a gear system comprising a rack and pinion system. A compression spring 50 is positioned on a spring support 52 in the form of an elongate cylindrical component. Upon activation of the insertion mechanism 22 with an activation mechanism, such as a button or other mechanism, the compression spring 50 is deployed such that the compression spring applies a force on a rack support 54. The rack support 54 is coupled to the spring support 52 with the rack support being positioned substantially perpendicular to the spring support such that the force of the spring 50 when deployed moves the rack support in the direction of arrow A.

[0082]

[0079] FIGS. 15 A, 15B, and 15C illustrate an exemplary embodiment of components of the rotation subassembly and needle support subassembly for use in an insertion mechanism of the present disclosure. The needle support subassembly can be used with the insertion mechanism of FIG. 7. The rotation subassembly includes a shaft 78 having thereon two bevel gears 74 and 76. A spring 50 may be disposed within the shaft 78. The spring 50 is coupled to the shaft such that the rotation of the spring is directly translated to the shaft to cause the shaft to rotate as well. The two bevel gears 74 and 76 interact with the drive arm gear 80, which in turn engages the drive arm 40. The drive arm 40 is rigidly connected to the drive arm gear 80 about its pivot and is meshed with the shaft having the partial bevel gears 74, 76, shown in FIG. 15 A. As shown in FIG. 15B, in some embodiments, the drive arm 40 is coupled to a drive arm gear 80 that is configured to selectively engage with the first partial bevel gear and the second partial bevel gear, which are located on the shaft, shown in more detail in FIG. 15C.

[0083]

[0080] As the shaft 78 rotates, the drive arm gear 80 engages with the first partial bevel gear 74 to pivot the drive arm 40 from the first end of the curved slot 30 to the second end of the curved slot 30. This deploys the needle and catheter into the skin to insert the catheter therein. As the shaft 78 continues to rotate, the drive arm gear 80 disengages from the first partial bevel gear 74 and engages with the second partial bevel gear 76. This reverses the motion of the drive arm 40 to move the drive arm 40 back to the first end of the curved slot 30 to retract the needle from the skin, leaving the catheter behind.

[0084]

[0081] FIGS. 16A, 16B, 16C, and 16D illustrate the motion of the drive arm relative to the curved slot as the shaft as the gears rotate to move the drive arm. As shown in FIG. 16A, the drive arm gear 80 engages with the first partial bevel gear 74 to move the drive arm 40 to the second end of the curved slot 30, shown in FIG. 16B. In this position, the needle is deployed into the skin. As shown in FIG. 16C, the drive arm gear 80 engages with the second partial bevel gear 76 to move the drive arm 40 from the second end of the curved slot 30 to the first end of the curved slot 30, shown in FIG. 16D, to retract the needle from the skin.

[0085]

[0082] FIG. 17 is a perspective view of an embodiment of portions of a rotation subassembly of an insertion mechanism where a torsion spring’s rotation translates through spur gears to power the rotation of a shaft with two partial bevel gears that would then connect with a drive arm of any of the insertion mechanisms of the present disclosure. Both directions of motion of a drive arm are driven by a single torsion spring 70 coupled to a series of gears. The rotation of the torsion spring 70 can be used to translate through a series of spur gears 72 to power the rotation of a shaft 78 with two partial bevel gears 74, 76. As the shaft 78 rotates, the first partial bevel gear 74 is configured to engage with the drive arm to rotate the needle for insertion into the skin surface. After the first partial bevel gear 74 clears and disengages from the drive arm, the second partial bevel gear 76 is configured to engage the drive arm to retract the needle. The shaft 78 rotates consistently throughout firing due to the torsion spring.

[0086]

[0083] FIGS. 18A, 18B and 18C illustrate an exemplary embodiment of components of the rotation subassembly and needle support subassembly for use in an insertion mechanism of the present disclosure. In the embodiment illustrated, the rotation subassembly 27 includes a drive arm 40, a gear stack coupled to the drive arm 40, and a torsion spring 100 that drives the gear system.

[0087]

[0084] In reference to FIGS. 19A-19D, in some embodiments, both directions of motion of the drive arm are provided by a torsion spring 100 coupled to a plurality of gear stacks. Each gear stack can include one or more individual gears. In some embodiments, four gear stacks 102, 104, 106, 108 can be used in combination to convert the tension in the torsion spring 100 to the forward and reverse motion of the drive arm 40 to move the needle hub and catheter hub.

[0088]

[0085] FIG. 19B illustrates a perspective view of the gear stacks, and FIG. 19C illustrates an exploded view of the gear stacks and torsion spring. A configuration of gears is placed on four axes of rotation for each of the four gear stacks. In some embodiments, a first gear stack 102 comprises a single gear 110 that is powered by the torsion spring. The single gear 110 of the first gear stack 102 includes teeth around the entire circumference of the gear to mesh with the second gear stack 104.

[0086] The second gear stack 104 comprises a large gear 112 configured to mesh with the single gear 110 of the first gear stack 102 and a small coaxial gear 114 configured to engage with both the third and fourth gear stacks 106, 108. The large gear 112 of the second gear stack includes teeth around the entire circumference. The large gear 112 of the second gear stack is configured to mesh with a smaller single gear 110 of the first gear stack, which effectively increases the torque. The small coaxial gear 114 of the second gear stack includes first and second sets of teeth 116, 118. The first set of teeth 116 on the small coaxial gear 114 extend along approximately half the length of the gear and are configured to engage with the third gear stack. The second set of teeth 118 on the small coaxial gear 114 extend along approximately the full length of the gear and are configured to engage with the four gear stack.

[0089]

[0087] The third gear stack 106 comprises a single gear 120 that includes a first set of teeth 122 around a portion of the circumference of the gear at a first end of the gear 120, and a second set of teeth 124 around the entire circumference of the gear at a second end of the gear 120. The first set of teeth 122 of the gear 120 of the third gear stack 106 are configured to cause movement of the drive arm from the second end of the curved slot to the first end of the curved slot to retract the needle hub. The second set of teeth 124 on the gear 120 of the third gear stack are configured to engage with the first set of teeth 116 on the small coaxial gear 114 of the second gear 104 stack to allow for continuous rotation of the third gear stack 106.

[0090]

[0088] The fourth gear stack 108 comprises a single gear 130 that includes teeth around the entire circumference of the gear. The fourth gear stack is also coupled to the drive arm of the insertion mechanism to move the needle hub and catheter hub along the curved slot.

[0091]

[0089] The interaction between the small coaxial gear of the fourth gear stack and the small partial-toothed gear portions of the second and third gear stacks cause forward and reverse movement of the needle hub and catheter hub. As explained above, the forward movement moves the needle hub and catheter hub to deploy the needle and the catheter into the skin when the partial-toothed portion of the gear of the second gear stack engages with the fourth gear stack. The reverse movement, caused by the partial-toothed portion of the gear of the third gear stack engaging with the fourth gear stack, moves the needle hub and needle back to their original position, leaving the catheter hub in the deployed positioned and the catheter in the skin.

[0092]

[0090] The single partial-toothed gear of the second gear stack is offset from the single partial-toothed gear of the third gear stack such that the teeth on the second gear stack and the third gear stack are extended into the plane of a gear on the fourth gear stack, causing partial rotation forward, then rotation backward of the drive arm as the gear of the fourth gear stack engages with the second gear stack and the third gear stack sequentially. As shown, the drive arm is coupled to the fourth gear stack.

[0093]

[0091] FIGS. 20A, 20B, and 20C show a partial cross-sectional view of the gear stacks to only show the portion of the gears that is in plane with the drive arm pinion on the fourth gear stack. As shown in FIG. 20 A, the small coaxial partial -toothed gear on the second gear stack 104 is configured to engage with the fourth gear stack 108. This causes rotation of the fourth gear stack 108 in a forward direction to cause the drive arm 40 to move along the curved slot from the first end to the second end. This causes deployment of the needle and catheter and insertion of the needle to the surface of the skin. Continued rotation of the gear causes the fourth gear stack 108 to disengage from the second gear stack 104, shown in FIG. 20B. After disengaging, the partial gear on the third gear stack 106 is configured to engage with the fourth gear stack 108, as shown in FIG. 20C. Engagement with the third gear stack 106 reverses the direction of the motion of the fourth gear stack 108, causing the drive arm 40 to move back to the first end of the curved slot, retracting the needle from the skin. As explained above, the second gear stack 104 and the third gear stack 106 are rotating continuously in opposite directions. The fourth gear stack 108 only rotates when meshed with either of the partial gears as shown in FIGS. 20A and 20C.

[0094]

[0092] Referring to FIGS. 24A-29, another embodiment of a rotation subassembly configured to rotate the drive arm 40 is depicted. The rotation subassembly of FIGS. 24A-29 need not include a gear system. The rotation subassembly of FIGS. 24A-29 can include a torsion spring and one or more rotatable linkages to rotate the drive arm 40. The rotation subassembly can reduce the required stroke of the actuator, such as the torsion spring, and allow for reversing the direction of needle movement. The ability of the rotation subassembly to reverse its own direction results in only needing a single source of actuation. Additionally, the reduced stroke size means that the volume taken up by the mechanism is significantly reduced relative to other solutions, allowing for a reduction in overall wearable device size.

[0095]

[0093] FIG. 24A depicts a perspective view of an insertion mechanism 22 including a rotation subassembly and a needle support subassembly. The rotation subassembly can include a preloaded torsion spring 70. In some embodiments, the rotation subassembly includes a linkage 302 coupled to the torsion spring 70. In some embodiments, the linkage 302 is driven to rotate about a pillar 304 by the torsion spring 70. In some embodiments, the rotation subassembly includes a drive arm 40. The drive arm 40 can be rotatably coupled to the linkage 302 at a first end of the drive arm 40. The drive arm 40 can be coupled to a carriage 310 of the needle hub 28 at a second end of the drive arm 40. The drive arm 40 can be rotatable coupled to the carriage 310.

[0096]

[0094] FIG. 24B depicts a top perspective view of partial components of the needle support assembly and the rotation subassembly. The needle support subassembly can include the needle hub 28 carrying the needle 28a and the catheter hub 34 carrying the catheter 34a, as described in above embodiments and discussed with respect to, at least, FIG. 6A. In some embodiments, the needle support subassembly includes a rail 320. The needle hub 28 can include the carriage 310. In some embodiments, the carriage includes one or more clips 312 configured to mate with and ride along the rail 320. In some embodiments, the needle hub 28 includes a support 314 that supports the needle, and fluid line coupled to the needle. In some embodiments, the needle support subassembly includes a track 330. The support 314 can be positioned within the track 330 for sliding along and within the track 330. In some embodiments, the catheter hub 34 can be positioned within the track 330 for sliding along and within the track 330.

[0097]

[0095] Referring to FIG. 25A and FIG. 25B, a pre-deployed configuration of the insertion mechanism 22 is depicted. FIG. 25A depicts a top perspective view of the insertion mechanism 22, and FIG. 25B a side perspective view of partial components of the insertion mechanism 22. In a pre-deployed configuration, the torsion spring 70 can be loaded and not yet actuated. In the pre-deployed configuration, the needle hub 28 can be positioned at a first end of the rail 320 and a first end of the track 330 (e.g., the carriage 320 can be positioned at the first end of the rail 320 and the support 314 can be positioned at the first end of the tracks 330). In some embodiments, the bushing 36 is positioned adjacent the torsion spring 70, or on the same side of the delivery device as the torsion spring 70, and opposite the first end of the rail 320 and the first end of the track 330. In some embodiments, in the pre-deployed configuration the linkage 302 can be positioned at 90 degrees about the pillar 304, as shown in FIG. 24A and FIG. 24B. In some embodiments, in the pre-deployed configuration, the linkage 302 can extend toward and substantially parallel to the rail 320 and the track 330. In some embodiments, in the pre-deployed configuration, the linkage 302 can be pointing 180 degrees from the bushing 36.

[0098]

[0096] Referring to FIG. 26, a top perspective view of the insertion mechanism 22 is 1 depicted, at a first time during deployment of the insertion mechanism 22. That is, FIG. 26 shows the insertion mechanism after the torsion spring 70 has been actuated, or the energy in the torsion spring has been released. Upon actuation of the torsion spring 70, the linkage 302 is driven to rotate about the pillar 304 in a first direction, such as the direction shown by arrow 340. As the linkage 302 rotates, the first end of the drive arm 40 coupled to the linkage 302 can also rotate about the pillar 304. As the linkage 302 rotates about the pillar 304, it applies a force on the drive arm 40 that is at least partially in the direction of the rail 320 and the track 330. The drive arm 40 therefore applies this force to the needle hub 28, and particularly to the carriage 310 of the needle hub 28. Because the needle hub 28 is coupled to the rail 320, the needle hub 28 is prevented from rotating. Instead, the force applied to the needle hub 28 from the linkage 302 and the drive arm 40 causes the needle hub 28 to move linearly in the direction of arrow 342 along the rail 320 and the track 330. That is, the rotational forces applied to the needle hub 28 and translated into linear forces by the rail 320 that constrains the needle hub 28.

[0099]

[0097] As the torsion spring 70 is actuated, the linkage 302 can rotate about the pillar 304. During a first stroke of the rotation, the linkage 302 can rotate toward the bushing 36, therefore moving the drive arm 40 and the needle hub 28 toward the bushing 36. In the example presently described, the linkage 302 and drive arm 40 can “pull” the needle hub 28 toward the bushing 36. Particularly, the needle hub 28 can travel linearly along the rail 320 and the tracks 330.

[0100]

[0098] Referring now to FIG. 27A and FIG. 27B, a second time, after the first time discussed with respect to FIG. 26, during deployment of the insertion mechanism is depicted. FIG. 27A depicts a top perspective view of the insertion mechanism 22, and FIG. 27B depicts a side perspective view of partial components of the insertion mechanism 22. FIG. 27A and FIG. 27B depict a completion of a first stroke of movement of the linkage 302 (or the drive arm 40), in the direction of the bushing 36, as the linkage 302 (or the first end of the drive arm 40) rotates about the pillar 304. In some embodiments, at the completion of the first stroke of movement, the linkage 302 can be positioned at 270 degrees about the pillar 304, as shown in FIG. 27A and FIG. 27B. In some embodiments, at the completion of the first stroke, the linkage 302 can extend away from and substantially parallel to the rail 320 and the track 330. When the linkage 302 has completed its first stroke, in the direction of the bushing 36, the drive arm 40 has applied force to the needle hub 28 to cause the needle hub 28 to move linearly in the direction of arrow 342 along the rail 320 and the track 330, such that the needle hub 28 is positioned at the second end of the rail 320 and substantially at the second end of the track 330. In the position depicted in FIG. 27A and FIG. 27B, the catheter and the needle can be deployed from the IDD into the user’s tissue.

[0101]

[0099] As in the above-discussed embodiments, the catheter hub 34 is configured to sit nearer to the bushing 36 and adjacent to the needle hub 28. In some embodiments, the needle hub 28 is sized and shaped such that the catheter hub 34 is held by the needle hub 28. As shown, the catheter hub 34 is loosely constrained by the needle hub 28 such that if the needle hub 28 moves toward the bushing 36, as shown in FIG. 27A and FIG. 27B, the needle hub 28 pushes the catheter hub 34 toward the bushing 36 as well. Therefore, at the completion of the first stroke of movement of the linkage 302 (or the drive arm 40), the catheter hub 34 can be positioned at the second end of the tracks 330.

[0102]

[0100] The bend of the needle 28a and the catheter 34a is enforced by the outlet bushing

[0103] 36 on one end, and the needle and catheter hubs on the other end. In this embodiment, the catheter hub 34 is nested within a front portion of the needle hub 28. As the needle 28a is attached to the needle hub 28 and the catheter 34a is attached to the catheter hub 34, the catheter 34a can be left behind in the tissue when the needle hub 28 and the needle 28a are retracted back into the IDD. Note, that as the needle 28a and catheter 34a are moved forward, the portion of the needle 28a and catheter 34a that extend beyond the outlet bushing 36 are no longer constrained into a bend, and therefore deploy straight at the specified insertion angle (for example, 55°).

[0104]

[0101] Referring now to FIG. 27C, which shows a perspective view of partial components of the insertion mechanism 22, in some embodiments, upon extending the catheter 34a to full length, the catheter hub 34 snaps into a latching mechanism 37. The latching mechanism 37 can be a portion of the tracks 330. The latching mechanism 37 can be positioned at the second end of the tracks 330. In some embodiments, the latching mechanism 37 includes a bar substantially perpendicular to the tracks 330. In some embodiments, the catheter hub 34 can include a ramped surface 350. During deployment, the ramped surface 350 can ride under the latching mechanism

[0105] 37 to deflect the latching mechanism 37 upward. In some embodiments, the catheter hub 34 includes a detent 352. In some embodiments, the detent 352 can be one or more grooves, teeth, or flat surfaces that contact the latching mechanism 37, thereby preventing the catheter hub 34 from sliding along the tracks 330 away from the bushing 36. As explained above, the catheter hub 34 is only constrained by the needle hub 28 in order to be pushed in the forward direction toward the bushing 36. As there is no mechanical connection between the catheter hub 34 and the needle hub 28, the needle hub 28 can retract from the catheter hub 34 and back towards its original position in the pre-deployed configuration of the insertion mechanism 22, leaving the catheter 34a and catheter hub 34 in the deployed position.

[0106]

[0102] For instance, referring to FIG. 28, which shows a top perspective view of partial components of the insertion mechanism 22 at a third time, after the second time, during deployment, the linkage 302 (or the drive arm 40) can continue to be driven to rotate about the pillar 304 in the first direction. During the continued rotation of the linkage 302 (or the drive arm 40), the linkage 302 (or the drive arm 40) can begin a second stroke of movement away from the bushing 36, therefore “pushing” the needle hub 28 linearly away from the bushing 36 and back toward the first ends of the rail 320 and the tracks 330 (e.g., in the direction of arrow 343).

[0107]

[0103] Referring now to FIG. 29, a fourth time, after the third time discussed with respect to FIG. 28, during deployment of the insertion mechanism is depicted. FIG. 29 depicts a top perspective view of partial components of the insertion mechanism 22. FIG. 29 depicts a completion of the second stroke of movement of the linkage assembly 302 (or the drive arm 40), in the direction away from the bushing 36, as the linkage 302 (or the first end of the drive arm 40) rotates about the pillar 304. FIG. 29 can depict a completion of a full rotation of the linkage assembly 302 (or the first end of the drive arm 40) about the pillar 304. In some embodiments, at the completion of the second stroke of movement or the rotation, the linkage 302 can be positioned at 90 degrees about the pillar 304, as shown in FIG. 29. In some embodiments, at the completion of the second stroke or the rotation, the linkage 302 can extend toward and substantially parallel to the rail 320 and the track 330. When the linkage 302 has completed its second stroke or rotation, the drive arm 40 has applied force to the needle hub 28 to cause the needle hub 28 to move linearly along the rail 320 and the track 330, such that the needle hub 28 is positioned at the first end of the rail 320 and the first end of the track 330. The configuration of the insertion mechanism 22 in FIG. 29 can be described as the post-deployment configuration.

[0108]

[0104] By adjusting the pre-loading of the torsion spring 70 and the initial position of the linkage 302 about the pillar 304, the insertion mechanism 22 can be particularly suited for different delivery device structures. For instance, referring to FIG. 30, a top transparent view of an IDD 10 is depicted. In contrast to the embodiment shown in FIGS. 24A-29, the bushing 36 is positioned on a side of the IDD 10 opposite the torsion spring 70. In such embodiments, for a first stroke of movement of the linkage 302 (or the drive arm 40) to move the needle hub 28 and catheter hub 34 from the pre-deployed configuration to the deployed configuration, the linkage 302 can be positioned at 270 degrees about the pillar 304 in the pre-deployed configuration, as shown in FIG. 30. In some embodiments, in the pre-deployed configuration, the linkage 302 can extend away from and substantially parallel to the rail 320 and the track 330. In some embodiments, in the pre-deployed configuration, the linkage 302 can be pointing 180 degrees from the bushing 36. Therefore, during deployment and rotation in the direction of the arrow 400, the drive arm 40 can “push” the needle hub 28 and the catheter hub 34, in the direction of arrow 402, toward the bushing 36 during a first stroke of movement until the linkage 302 is positioned at 90 degrees about the pillar 304. Continued rotation of the linkage assembly 302 can “pull” the needle hub 28 in the direction of arrow 404 to the post-deployment position.

[0109]

[0105] Referring to FIG. 31, a variation of the embodiment shown in FIG. 30 is depicted. FIG. 31 depicts a top view of an IDD 10. The embodiment of FIG. 31 differs from that shown in FIG. 30 in that the catheter and needle are deployed from a location in the IDD 10 nearer to the center of the IDD 10. To enable this, for a first stroke of movement of the linkage 302 (or the drive arm 40) to move the needle hub 28 and catheter hub 34 from the pre-deployed configuration to the deployed configuration, the linkage 302 can be positioned about the pillar 304 in the predeployed configuration such that its first stroke of movement includes less than 180 degrees of rotation, as shown in FIG. 30. For instance, in some embodiments, in the pre-deployed configuration, the linkage 302 is positioned at roughly 180 degrees about the pillar. In some embodiments, in the pre-deployed configuration, the linkage 302 can extend away from and at a non- parallel angle to the rail 320 and the track 330. During deployment and rotation in the direction of the arrow 400, the drive arm 40 can “push” the needle hub 28 and the catheter hub 34 toward the bushing 36, in the direction of the arrow 402, during a first stroke of movement (shorter than the first stroke discussed with respect to FIG. 30) until the linkage 302 is positioned at 90 degrees about the pillar 304 and the catheter is deployed. Continued rotation of the linkage assembly 302 can “pull” the needle hub 28 in the direction of the arrow 404 to the postdeployment position.

[0110]

[0106] Referring to FIG. 32, another embodiment of an IDD 10 is depicted. In some embodiments, the IDD 10 can include multiple linkage assemblies. For instance, activation of the torsion spring 70 to deploy the catheter and needle can cause rotation of the link 302 in the direction of the arrow 400. As the link 302 moves in the direction of the arrow 400, it can move a first drive arm 410 in the direction of the arrow 402. In some embodiments, as the link 302 moves in the direction of the arrow 400, it can move the first drive arm 410 linearly in the direction of the arrow 402. The first drive arm 410 can be moved in a direction opposite the bushing 36, which can be on a near side of the IDD 10 compared to the torsion spring 70. The first drive arm 410 can be coupled at its second end to a rotary disc 412. Therefore, movement of the first drive arm 410 in the direction of the arrow 402 can cause the rotary disc 412 to rotate in the direction of the arrow 406. A second drive arm 414 can be coupled to the rotary disc 412 at a first end of the second drive arm 414. The second drive arm 414 can be coupled to the needle hub 28 at a second end of the second drive arm 414. As the rotary disc 412 rotates in the direction of the arrow 406, the second drive arm 414 moves in the direction of the arrow 408, which in turn pushes the needle hub 28 and the catheter hub 34 in the direction of the arrow 408. Specifically, the needle hub 28 and the catheter hub 34 can be pushed in the direction of the bushing 36 to deploy the catheter and needle from the IDD 10.

[0111]

[0107] FIG. 21 A and FIG. 21 B show an embodiment of some of the inner components of an infusion delivery device of the present disclosure including an insertion mechanism. The IDD 10 includes inside the housing a reservoir 24 for holding medicament, a plunger assembly 25 to expel the medicament from the reservoir 24, a motor 23 to drive the plunger assembly 25, and a power source 21, such as a battery, to provide power to the motor 23. The insertion mechanism 22 is also positioned within the housing and is used to insert a needle concentrically disposed in a catheter to a specified depth in tissue, and then remove the needle, leaving the catheter behind. The catheter of the insertion mechanism 22 is fluidly connected to the reservoir 24 to deliver the medicament from the reservoir 24 to the patient. The insertion mechanism 22 can be sized and shaped to minimize the size of the IDD. In some embodiments, the insertion mechanism 22 is positioned entirely within the housing. In some embodiments, the insertion mechanism 22 is positioned parallel to the reservoir. As is described above, the insertion mechanism 22 is designed to move a needle, which is initially positioned inside the insertion mechanism 22 with a curved or bent shape, in a curved path such that a distal end of the needle is inserted at an angle relative to the surface of the skin of the patient. In some embodiments, the needle is configured to be inserted into the surface of the skin at an angle of approximately 55 degrees.

[0112]

[0108] FIG. 22A and FIG. 22B show an embodiment of some of the inner components of an infusion delivery device of the present disclosure including an insertion mechanism. The IDD 10 includes inside the housing a reservoir 24 for holding medicament, a plunger assembly 25 to expel the medicament from the reservoir 24, a motor 23 to drive the plunger assembly 25, and a power source 21, such as a battery, to provide power to the motor 23. The insertion mechanism 22 is also positioned within the housing and is used to insert a needle concentrically disposed in a catheter to a specified depth in tissue, and then remove the needle, leaving the catheter behind. The catheter of the insertion mechanism 22 is fluidly connected to the reservoir 24 to deliver the medicament from the reservoir 24 to the patient. The insertion mechanism 22 can be sized and shaped to minimize the size of the IDD. In some embodiments, the insertion mechanism 22 is positioned entirely within the housing. In some embodiments, the insertion mechanism 22 is positioned parallel to the reservoir. As is described above, the insertion mechanism 22 is designed to move a needle, which is initially positioned inside the insertion mechanism 22 with a curved or bent shape, in a curved path such that a distal end of the needle is inserted at an angle relative to the surface of the skin of the patient. In some embodiments, the needle is configured to be inserted into the surface of the skin at an angle of approximately 55 degrees.

[0113]

[0109] FIG. 23A and FIG. 23B show an embodiment of some of the inner components of an infusion delivery device of the present disclosure including an insertion mechanism. The IDD 10 includes inside the housing a reservoir 24 for holding medicament, a plunger assembly 25 to expel the medicament from the reservoir 24, a motor 23 to drive the plunger assembly 25, and a power source 21, such as a battery, to provide power to the motor 23. The insertion mechanism 22 is also positioned within the housing and is used to insert a needle concentrically disposed in a catheter to a specified depth in tissue, and then remove the needle, leaving the catheter behind. The catheter of the insertion mechanism 22 is fluidly connected to the reservoir 24 to deliver the medicament from the reservoir 24 to the patient. The insertion mechanism 22 can be sized and shaped to minimize the size of the IDD. In some embodiments, the insertion mechanism 22 is positioned entirely within the housing. In some embodiments, the insertion mechanism 22 is positioned parallel to the reservoir. The insertion mechanism 22 is designed to move a needle, which is initially positioned inside the insertion mechanism 22 with a curved or bent shape, in a curved path such that a distal end of the needle is inserted at an angle relative to the surface of the skin of the patient. In some embodiments, the needle is configured to be inserted into the surface of the skin at an angle of approximately 55 degrees.

[0114] [HO] The present disclosure provides compact insertion mechanisms that may allow for a reduction in size of infusion delivery devices, such as pumps.

[0115]

[0111] In some embodiments, an insertion mechanism of the present disclosure comprises a catheter hub having a catheter coupled thereto; a needle hub having a needle coupled thereto and positioned proximal of the catheter hub; and a drive arm having a first end attached to the needle hub and a second end including a pivot point such that the drive arm is configured to rotate in a first direction to cause the needle hub to push the catheter hub distally along a curved pathway to achieve insertion of the needle and the catheter into tissue at an angle relative to a surface of the tissue, and to rotate in a second direction opposite the first direction to cause the needle hub to move proximally along the curved pathway to achieve retraction of the needle from the catheter, wherein the curved pathway has a radius defined by a virtual pivot point.

[0116]

[0112] In some embodiments, an insertion mechanism of the present disclosure comprises a catheter hub having a catheter coupled thereto; a needle hub having a needle coupled thereto and positioned proximal of the catheter hub; a rotation subassembly comprising a drive arm having a first end attached to the needle hub and a second end including a pivot point such that the drive arm is configured to rotate in a first direction to cause the needle hub to push the catheter hub distally along a curved pathway to achieve insertion of the needle and the catheter into tissue at an angle relative to a surface of the tissue, and to rotate in a second direction opposite the first direction to cause the needle hub to move proximally along the curved pathway to achieve retraction of the needle from the catheter; a gear assembly coupled to the drive arm and configured to move the drive arm in the first and second directions; and a spring configured to apply a force on the gear assembly to cause movement of the drive arm.

[0117]

[0113] In some embodiments, the gear assembly may comprise a rack support having an upper rack and an opposed lower rack; and a pinion coupled to the drive arm and positioned on the rack support between the upper rack and the opposed lower rack, wherein the spring is configured to apply a force to the rack support such that movement of the rack support allows the pinion to sequentially engage with the upper rack and the opposed lower rack, engagement between the upper rack and the pinion being configured to move the drive arm in the first direction and engagement between the opposed lower rack and the pinion being configured to move the drive arm in the second direction.

[0118]

[0114] In some embodiments, the gear assembly may comprise first and second partial bevel gears, the spring being configured to apply a force to rotate the first and second partial bevel gears such that the first and second partial bevel gears are configured to sequentially engage with the drive arm, engagement between the first partial bevel gear being configured to move the drive arm in the first direction and engagement with the second partial bevel gear being configured to move the drive arm in the second direction.

[0119]

[0115] In some embodiments, the gear assembly may comprise a plurality of gear stacks coupled to the spring and the drive arm, the plurality of gear stacks comprising a first stack coupled to the spring and comprising a single gear that includes teeth around an entire circumference of the gear, a second gear stack comprising a large gear configured to mesh with the single gear of the first gear stack and a small coaxial gear, a third gear stack comprising a single gear that includes a first set of teeth around a portion of the circumference of the gear at a first end of the gear, and a second set of teeth around the entire circumference of the gear at a second end of the gear, and a fourth gear stack coupled to the drive arm and comprising a single gear that includes teeth around the entire circumference of the gear, wherein engagement between small coaxial gear of the second gear stack and the single gear of the fourth gear stack is configured to move the drive arm in the first direction, and engagement between the first set of teeth of the single gear of the third gear stack and the single gear of the fourth gear stack is configured to move the drive arm in the second direction.

[0120]

[0116] In some embodiments, the present disclosure provides a drug delivery device comprising a reservoir for holding medicament, a plunger assembly to expel the medicament from the reservoir, a motor to drive the plunger assembly, a power source for the motor, and an insertion mechanism according to one or more embodiments described above, wherein a catheter of the insertion mechanism is fluidly connected to the reservoir to deliver the medicament from the reservoir to a patient

[0121]

[0117] Non-limiting embodiments of the present disclosure are set out in the following clauses:

[0122]

[0118] Clause 1. An insertion mechanism, comprising: a catheter hub having a catheter coupled thereto; a needle hub having a needle coupled thereto and positioned proximal of the catheter hub; and a drive arm having a first end attached to the needle hub and a second end including a pivot point such that the drive arm is configured to rotate in a first direction to cause the needle hub to push the catheter hub distally along a curved pathway to achieve insertion of the needle and the catheter into tissue at an angle relative to a surface of the tissue, and to rotate in a second direction opposite the first direction to cause the needle hub to move proximally along the curved pathway to achieve retraction of the needle from the catheter, wherein the curved pathway has a radius defined by a virtual pivot point.

[0123]

[0119] Clause 2. The insertion mechanism of clause 1, wherein: the drive arm comprises a slot; and the needle hub comprises a pin, wherein the pin is received in the slot to attach the drive arm to the needle hub.

[0124]

[0120] Clause 3. The insertion mechanism of clause 1 or clause 2, wherein the needle hub comprises one or more pins received within the curved pathway.

[0125]

[0121] Clause 4. The insertion mechanism of any one of clauses 1-3, further comprising a latch positioned at a distal end of the curved pathway, wherein: the latch comprises a tab having a cutout therein; the catheter hub comprises a boss; and during insertion of the needle and the catheter into the tissue, the catheter hub is configured to deflect the tab until the boss seats within the cutout of the tab, locking the catheter hub in place.

[0126]

[0122] Clause 5. An insertion mechanism, comprising: a catheter hub having a catheter coupled thereto; a needle hub having a needle coupled thereto and positioned proximal of the catheter hub; and a rotation subassembly comprising: a drive arm having a first end attached to the needle hub and a second end including a pivot point such that the drive arm is configured to move in a first direction to cause the needle hub to push the catheter hub distally to achieve insertion of the needle and the catheter into tissue at an angle relative to a surface of the tissue, and to move in a second direction opposite the first direction to cause the needle hub to move proximally to achieve retraction of the needle from the catheter; a gear assembly coupled to the drive arm and configured to move the drive arm in the first and second directions; and a spring configured to apply a force on the gear assembly to cause movement of the drive arm.

[0127]

[0123] Clause 6. The insertion mechanism of clause 5, wherein the gear assembly comprises: a rack support having an upper rack and an opposed lower rack; and a pinion coupled to the drive arm and positioned on the rack support between the upper rack and the opposed lower rack, wherein the spring is configured to apply a force to the rack support such that movement of the rack support allows the pinion to sequentially engage with the upper rack and the opposed lower rack, engagement between the upper rack and the pinion being configured to move the drive arm in the first direction and engagement between the opposed lower rack and the pinion being configured to move the drive arm in the second direction.

[0124] Clause 7. The insertion mechanism of clause 5 or clause 6, further comprising a spring support configured to support the spring, wherein the spring support is coupled to and substantially perpendicular to the rack support.

[0128]

[0125] Clause 8. The insertion mechanism of any one of clauses 5-7, wherein the gear assembly comprises first and second partial bevel gears, the spring being configured to apply a force to rotate the first and second partial bevel gears such that the first and second partial bevel gears are configured to sequentially engage with the drive arm, engagement between the first partial bevel gear being configured to move the drive arm in the first direction and engagement with the second partial bevel gear being configured to move the drive arm in the second direction.

[0129]

[0126] Clause 9. The insertion mechanism of any one of clauses 5-8, wherein the gear assembly further comprises: a shaft configured to rotate, having the first and second partial bevel gears positioned thereon; and a drive gear rigidly coupled to the drive arm about the pivot point of the drive arm, wherein the drive arm is meshed with the shaft.

[0130]

[0127] Clause 10. The insertion mechanism of any one of clauses 5-9, wherein the gear assembly further comprises one or more spur gears configured to rotate the shaft.

[0131]

[0128] Clause 11. The insertion mechanism of any one of clauses 5-10, wherein the gear assembly comprises a plurality of gear stacks coupled to the spring and the drive arm, the plurality of gear stacks comprising: a first gear stack coupled to the spring and comprising a single gear that includes teeth around an entire circumference of the single gear; a second gear stack comprising a large gear configured to mesh with the single gear of the first gear stack and a small coaxial gear; a third gear stack comprising a single gear that includes a first set of teeth around a portion of a circumference of the single gear of the third gear stack at a first end of the single gear of the third gear stack and a second set of teeth around an entire circumference of the single gear of the third gear stack at a second end of the single gear of the third gear stack; and a fourth gear stack coupled to the drive arm and comprising a single gear that includes teeth around an entire circumference of the single gear of the fourth gear stack, wherein: engagement between small coaxial gear of the second gear stack and the single gear of the fourth gear stack is configured to move the drive arm in the first direction; and engagement between the first set of teeth of the single gear of the third gear stack and the single gear of the fourth gear stack is configured to move the drive arm in the second direction.

[0132]

[0129] Clause 12. The insertion mechanism of any one of clauses 5-11, wherein the small coaxial gear of the second gear stack is configured to engage with both the third gear stack and the fourth gear stack.

[0133]

[0130] Clause 13. The insertion mechanism of any one of clauses 5-12, wherein the small coaxial gear of the second gear stack comprises: a first set of teeth extending along approximately half of a length of the small coaxial gear and configured to engage with the third gear stack; and a second set of teeth extending along approximately a full length of the small coaxial gear and configured to engage with the fourth gear stack.

[0134]

[0131] Clause 14. The insertion mechanism of any one of clauses 5-13, wherein the second set of teeth on the single gear of the third gear stack are configured to engage with the first set of teeth on the small coaxial gear of the second gear stack to allow for continuous rotation of the third gear stack.

[0135]

[0132] Clause 15. The insertion mechanism of any one of clauses 5-14, wherein the small coaxial gear of the second gear stack is offset from the single gear of the third gear stack such that the teeth on the second gear stack and the third gear stack are extended into a plane of the single gear of the fourth gear stack, wherein engagement of the fourth gear stack with the second gear stack and the third gear stack sequentially is configured to cause partial rotation forward, then rotation backward, of the drive arm.

[0136]

[0133] Clause 16. The insertion mechanism of any one of clauses 5-15, wherein: the second gear stack and the third gear stack are configured to rotate continuously in opposite directions; and the fourth gear stack is configured to only rotate when meshed with either of the second set of teeth of the small coaxial gear of the second gear stack or the first set of teeth of the single gear of the third gear stack.

[0137]

[0134] Clause 17. The insertion mechanism of any one of clauses 5-16, wherein the large gear of the second gear stack comprises teeth around the entire circumference.

[0138]

[0135] Clause 18. The insertion mechanism of any one of clauses 5-17, further comprising a trigger configured to compress the spring, wherein the trigger is configured to be moved to allow the spring to release, wherein when the spring releases it is configured to apply the force on the gear assembly to cause movement of the drive arm.

[0139]

[0136] Clause 19. The insertion mechanism of any one of clauses 5-18, wherein: the trigger comprises a first end and a pivot point; a shape memory wire is configured to be coupled to the trigger; in a first position of the trigger, the first end of the trigger is configured to contact the catheter hub to compress the spring; and the shape memory wire is configured to change shape to move the trigger into a second position about the pivot point, wherein in the second position, the first end of the trigger does not contact the catheter hub to allow the spring to release.

[0140]

[0137] Clause 20. The insertion mechanism of any one of clauses 5-19, wherein the shape memory wire is configured to be heated to change shape.

[0141]

[0138] Clause 21. A drug delivery device, comprising: a reservoir for holding medicament; a plunger assembly to expel the medicament from the reservoir; a motor to drive the plunger assembly; a power source for the motor; and the insertion mechanism according to any one of clauses 1-20, wherein a catheter of the insertion mechanism is fluidly connected to the reservoir to deliver the medicament from the reservoir to a patient.

[0142]

[0139] Clause 22. An infusion delivery device, comprising: a reservoir for holding medicament; a plunger assembly to expel the medicament from the reservoir; a motor to drive the plunger assembly; a power source for the motor; an outlet; and an insertion mechanism, comprising: a torsion spring; a needle hub configured to carry a needle, wherein the needle hub is constrained to moving along a linear direction: a catheter hub configured to carry a catheter, wherein the catheter hub is configured to be constrained by the needle hub; and a drive arm coupled to the torsion spring at a first end of the drive arm and coupled to the needle hub at a second end of the drive arm, wherein: actuation of the torsion spring is configured to rotate the first end of the drive arm in a first direction; and rotation of the drive arm in the first direction is configured to move the needle hub in the linear direction toward the outlet and to move the needle hub in the linear direction away from the outlet.

[0143]

[0140] Clause 23. The infusion delivery device of clause 22, wherein: a first stroke of the rotation of the drive arm in the first direction is configured to move the needle hub in the linear direction toward the outlet; and a second stroke of the rotation of the drive arm in the first direction is configured to move the needle hub in the linear direction away from the outlet.

[0144]

[0141] Clause 24. The infusion delivery device of clause 22 or clause 23, wherein movement of the needle hub in the linear direction toward the outlet is configured to move the catheter hub in the linear direction toward the outlet.

[0145]

[0142] Clause 25. The infusion delivery device of any one of clauses 22-24, wherein: movement of the needle hub in the linear direction toward the outlet is configured to deploy the needle from the outlet; and movement of the catheter hub in the linear direction toward the outlet is configured to deploy the catheter from the outlet.

[0146]

[0143] Clause 26. The infusion delivery device of any one of clauses 22-25, wherein the catheter hub is configured to engage a latch such that the second stroke of rotation of the drive arm in the first direction does not result in movement of the catheter hub in the linear direction away from the outlet.

[0147]

[0144] Clause 27. The infusion delivery device of any one of clauses 22-26, wherein the catheter hub comprises: a ramped surface configured to ride under the latch; and a detent configured to engage the latch such that the second stroke of rotation of the drive arm in the first direction does not result in movement of the catheter hub in the linear direction away from the outlet.

[0148]

[0145] Clause 28. The infusion delivery device of any one of clauses 22-27, wherein: the insertion mechanism further comprises a linkage coupled to the torsion spring; and the first end of the drive arm is coupled to the linkage.

[0149]

[0146] Clause 29. The infusion delivery device of any one of clauses 22-28, further comprising a rail, wherein the needle hub comprises a carriage configured to slide along the rail in the linear direction.

[0150]

[0147] Clause 30. The infusion delivery device of any one of clauses 22-29, wherein the rail is configured to constrain the needle hub to motion in the linear direction.

[0151]

[0148] Clause 31. The infusion delivery device of any one of clauses 22-30, wherein the second end of the drive arm is coupled to the carriage.

[0152]

[0149] Clause 32. The infusion delivery device of any one of clauses 22-31, further comprising a track, wherein: the needle hub comprises a support configured to carry the needle; and the support is positioned within the track and is configured to slide along the track in the linear direction.

[0153]

[0150] Clause 33. The infusion delivery device of any one of clauses 22-32, wherein the catheter hub is positioned within the track and is configured to slide along the track in the linear direction.

[0154]

[0151] Clause 34. An insertion mechanism, comprising: a catheter hub having a catheter coupled thereto; a needle hub having a needle coupled thereto and positioned proximal of the catheter hub; a drive arm configured to actuate the needle hub and the catheter hub; and a drive mechanism configured to drive the drive arm to move in a first direction to cause the needle hub to push the catheter hub distally to achieve insertion of the needle and the catheter into tissue at an angle relative to a surface of the tissue, and to move the drive arm in a second direction opposite the first direction to cause the needle hub to move proximally to achieve retraction of the needle from the catheter.

[0155]

[0152] Clause 35. The insertion mechanism of clause 34, wherein: the drive arm comprises a slot; and the needle hub comprises a pin, wherein the pin is received in the slot to attach the drive arm to the needle hub.

[0156]

[0153] Clause 36. The insertion mechanism of clause 34 or clause 35, further comprising a latch, wherein: the latch comprises a tab having a cutout therein; the catheter hub comprises a boss; and during insertion of the needle and the catheter into the tissue, the catheter hub is configured to deflect the tab until the boss seats within the cutout of the tab, locking the catheter hub in place.

[0157]

[0154] Clause 37. The insertion mechanism of any one of clauses 34-36, wherein the drive mechanism further comprises: a gear assembly coupled to the drive arm and configured to move the drive arm in the first and second directions; and a spring configured to apply a force on the gear assembly to cause movement of the drive arm.

[0158]

[0155] Clause 38. The insertion mechanism of any one of clauses 34-37, wherein the gear assembly comprises: a rack support having an upper rack and an opposed lower rack; and a pinion coupled to the drive arm and positioned on the rack support between the upper rack and the opposed lower rack, wherein the spring is configured to apply a force to the rack support such that movement of the rack support allows the pinion to sequentially engage with the upper rack and the opposed lower rack, engagement between the upper rack and the pinion being configured to move the drive arm in the first direction and engagement between the opposed lower rack and the pinion being configured to move the drive arm in the second direction.

[0159]

[0156] Clause 39. The insertion mechanism of any one of clauses 34-38, further comprising a spring support configured to support the spring, wherein the spring support is coupled to and substantially perpendicular to the rack support.

[0160]

[0157] Clause 40. The insertion mechanism of any one of clauses 34-39, wherein the gear assembly comprises first and second partial bevel gears, the spring being configured to apply a force to rotate the first and second partial bevel gears such that the first and second partial bevel gears are configured to sequentially engage with the drive arm, engagement between the first partial bevel gear being configured to move the drive arm in the first direction and engagement with the second partial bevel gear being configured to move the drive arm in the second direction.

[0161]

[0158] Clause 41. The insertion mechanism of any one of clauses 34-40, wherein the gear assembly further comprises: a shaft configured to rotate, having the first and second partial bevel gears positioned thereon; and a drive gear rigidly coupled to the drive arm, wherein the drive arm is meshed with the shaft.

[0162]

[0159] Clause 42. The insertion mechanism of any one of clauses 34-41, wherein the gear assembly further comprises one or more spur gears configured to rotate the shaft.

[0163]

[0160] Clause 43. The insertion mechanism of any one of clauses 34-42, wherein the gear assembly comprises a plurality of gear stacks coupled to the spring and the drive arm, the plurality of gear stacks comprising: a first gear stack coupled to the spring and comprising a single gear that includes teeth around an entire circumference of the single gear; a second gear stack comprising a large gear configured to mesh with the single gear of the first gear stack and a small coaxial gear; a third gear stack comprising a single gear that includes a first set of teeth around a portion of a circumference of the single gear of the third gear stack at a first end of the single gear of the third gear stack and a second set of teeth around an entire circumference of the single gear of the third gear stack at a second end of the single gear of the third gear stack; and a fourth gear stack coupled to the drive arm and comprising a single gear that includes teeth around an entire circumference of the single gear of the fourth gear stack, wherein: engagement between small coaxial gear of the second gear stack and the single gear of the fourth gear stack is configured to move the drive arm in the first direction; and engagement between the first set of teeth of the single gear of the third gear stack and the single gear of the fourth gear stack is configured to move the drive arm in the second direction.

[0164]

[0161] Clause 44. The insertion mechanism of any one of clauses 34-43, wherein the small coaxial gear of the second gear stack is configured to engage with both the third gear stack and the fourth gear stack.

[0165]

[0162] Clause 45. The insertion mechanism of any one of clauses 34-44, wherein the small coaxial gear of the second gear stack comprises: a first set of teeth extending along approximately half of a length of the small coaxial gear and configured to engage with the third gear stack; and a second set of teeth extending along approximately a full length of the small coaxial gear and configured to engage with the fourth gear stack.

[0166] 31

[0163] Clause 46. The insertion mechanism of any one of clauses 34-45, wherein the second set of teeth on the single gear of the third gear stack are configured to engage with the first set of teeth on the small coaxial gear of the second gear stack to allow for continuous rotation of the third gear stack.

[0167]

[0164] Clause 47. The insertion mechanism of any one of clauses 34-46, wherein the small coaxial gear of the second gear stack is offset from the single gear of the third gear stack such that the teeth on the second gear stack and the third gear stack are extended into a plane of the single gear of the fourth gear stack, wherein engagement of the fourth gear stack with the second gear stack and the third gear stack sequentially is configured to cause partial rotation forward, then rotation backward, of the drive arm.

[0168]

[0165] Clause 48. The insertion mechanism of any one of clauses 34-47, wherein: the second gear stack and the third gear stack are configured to rotate continuously in opposite directions; and the fourth gear stack is configured to only rotate when meshed with either of the second set of teeth of the small coaxial gear of the second gear stack or the first set of teeth of the single gear of the third gear stack.

[0169]

[0166] Clause 49. The insertion mechanism of any one of clauses 34-48, wherein the large gear of the second gear stack comprises teeth around the entire circumference.

[0170]

[0167] Clause 50. The insertion mechanism of any one of clauses 34-49, further comprising a trigger configured to compress the spring, wherein the trigger is configured to be moved to allow the spring to release, wherein when the spring releases it is configured to apply the force on the gear assembly to cause movement of the drive arm.

[0171]

[0168] Clause 51. The insertion mechanism of any one of clauses 34-50, wherein: the trigger comprises a first end and a pivot point; a shape memory wire is configured to be coupled to the trigger; in a first position of the trigger, the first end of the trigger is configured to contact the catheter hub to compress the spring; and the shape memory wire is configured to change shape to move the trigger into a second position about the pivot point, wherein in the second position, the first end of the trigger does not contact the catheter hub to allow the spring to release.

[0172]

[0169] Clause 52. The insertion mechanism of any one of clauses 34-51, wherein the shape memory wire is configured to be heated to change shape.

[0173]

[0170] All patents and publications mentioned in this specification are herein incorporated by reference to the same extent as if each independent patent and publication was specifically and individually indicated to be incorporated by reference.

[0174]

[0171] As utilized herein, the terms “comprise” and “comprising” are intended to be construed as being inclusive, not exclusive. As utilized herein, the terms “exemplary”, “example”, and “illustrative”, are intended to mean “serving as an example, instance, or illustration” and should not be construed as indicating, or not indicating, a preferred or advantageous configuration relative to other configurations. As utilized herein, the terms “about”, “generally”, and “approximately” are intended to cover variations that may existing in the upper and lower limits of the ranges of subjective or objective values, such as variations in properties, parameters, sizes, and dimensions. In one non-limiting example, the terms “about”, “generally”, and “approximately” mean at, or plus 10 percent or less, or minus 10 percent or less. In one nonlimiting example, the terms “about”, “generally”, and “approximately” mean sufficiently close to be deemed by one of skill in the art in the relevant field to be included. As utilized herein, the term “substantially” refers to the complete or nearly complete extend or degree of an action, characteristic, property, state, structure, item, or result, as would be appreciated by one of skill in the art. For example, an object that is “substantially” circular would mean that the object is either completely a circle to mathematically determinable limits, or nearly a circle as would be recognized or understood by one of skill in the art. The exact allowable degree of deviation from absolute completeness may in some instances depend on the specific context. However, in general, the nearness of completion will be so as to have the same overall result as if absolute and total completion were achieved or obtained. The use of “substantially” is equally applicable when utilized in a negative connotation to refer to the complete or near complete lack of an action, characteristic, property, state, structure, item, or result, as would be appreciated by one of skill in the art. The use of the terminology X “or” Y herein should be interpreted as meaning either “X” or “Y” individually, or both “X and Y” together.

[0175]

[0172] Many modifications and alternative embodiments of the present disclosure will be apparent to those skilled in the art in view of the foregoing description. Accordingly, this description is to be construed as illustrative only and is for the purpose of teaching those skilled in the art the best mode for carrying out the present disclosure. Details of the structure may vary substantially without departing from the spirit of the present disclosure, and exclusive use of all modifications that come within the scope of any appended claims is reserved. Within this specification, embodiments have been described in a way which enables a clear and concise specification to be written, but it is intended and will be appreciated that embodiments may be variously combined or separated without parting from the scope of the present disclosure. It is intended that the present disclosure be limited only to the extent required by any appended claims and the applicable rules of law.

Claims

CLAIMSWhat is claimed is:

1. An insertion mechanism, comprising: a catheter hub having a catheter coupled thereto; a needle hub having a needle coupled thereto and positioned proximal of the catheter hub; and a drive arm having a first end attached to the needle hub and a second end including a pivot point such that the drive arm is configured to rotate in a first direction to cause the needle hub to push the catheter hub distally along a curved pathway to achieve insertion of the needle and the catheter into tissue at an angle relative to a surface of the tissue, and to rotate in a second direction opposite the first direction to cause the needle hub to move proximally along the curved pathway to achieve retraction of the needle from the catheter, wherein the curved pathway has a radius defined by a virtual pivot point.

2. The insertion mechanism of claim 1 , wherein: the drive arm comprises a slot; and the needle hub comprises a pin, wherein the pin is received in the slot to attach the drive arm to the needle hub.

3. The insertion mechanism of claim 1, wherein the needle hub comprises one or more pins received within the curved pathway.

4. The insertion mechanism of claim 1 , further comprising a latch positioned at a distal end of the curved pathway, wherein: the latch comprises a tab having a cutout therein; the catheter hub comprises a boss; and during insertion of the needle and the catheter into the tissue, the catheter hub is configured to deflect the tab until the boss seats within the cutout of the tab, locking the catheter hub in place.

5. An insertion mechanism, comprising:a catheter hub having a catheter coupled thereto; a needle hub having a needle coupled thereto and positioned proximal of the catheter hub; and a rotation subassembly comprising: a drive arm having a first end attached to the needle hub and a second end including a pivot point such that the drive arm is configured to move in a first direction to cause the needle hub to push the catheter hub distally to achieve insertion of the needle and the catheter into tissue at an angle relative to a surface of the tissue, and to move in a second direction opposite the first direction to cause the needle hub to move proximally to achieve retraction of the needle from the catheter; a gear assembly coupled to the drive arm and configured to move the drive arm in the first and second directions; and a spring configured to apply a force on the gear assembly to cause movement of the drive arm.

6. The insertion mechanism of claim 5, wherein the gear assembly comprises: a rack support having an upper rack and an opposed lower rack; and a pinion coupled to the drive arm and positioned on the rack support between the upper rack and the opposed lower rack, wherein the spring is configured to apply a force to the rack support such that movement of the rack support allows the pinion to sequentially engage with the upper rack and the opposed lower rack, engagement between the upper rack and the pinion being configured to move the drive arm in the first direction and engagement between the opposed lower rack and the pinion being configured to move the drive arm in the second direction.

7. The insertion mechanism of claim 6, further comprising a spring support configured to support the spring, wherein the spring support is coupled to and substantially perpendicular to the rack support.

8. The insertion mechanism of claim 5, wherein the gear assembly comprises first and second partial bevel gears, the spring being configured to apply a force to rotate the first and second partial bevel gears such that the first and second partial bevel gears are configured to sequentially engagewith the drive arm, engagement between the first partial bevel gear being configured to move the drive arm in the first direction and engagement with the second partial bevel gear being configured to move the drive arm in the second direction.

9. The insertion mechanism of claim 8, wherein the gear assembly further comprises: a shaft configured to rotate, having the first and second partial bevel gears positioned thereon; and a drive gear rigidly coupled to the drive arm about the pivot point of the drive arm, wherein the drive arm is meshed with the shaft.

10. The insertion mechanism of claim 9, wherein the gear assembly further comprises one or more spur gears configured to rotate the shaft.

11. The insertion mechanism of claim 5, wherein the gear assembly comprises a plurality of gear stacks coupled to the spring and the drive arm, the plurality of gear stacks comprising: a first gear stack coupled to the spring and comprising a single gear that includes teeth around an entire circumference of the single gear; a second gear stack comprising a large gear configured to mesh with the single gear of the first gear stack and a small coaxial gear; a third gear stack comprising a single gear that includes a first set of teeth around a portion of a circumference of the single gear of the third gear stack at a first end of the single gear of the third gear stack and a second set of teeth around an entire circumference of the single gear of the third gear stack at a second end of the single gear of the third gear stack; and a fourth gear stack coupled to the drive arm and comprising a single gear that includes teeth around an entire circumference of the single gear of the fourth gear stack, wherein: engagement between small coaxial gear of the second gear stack and the single gear of the fourth gear stack is configured to move the drive arm in the first direction; and engagement between the first set of teeth of the single gear of the third gear stack and the single gear of the fourth gear stack is configured to move the drive arm in the second direction.

12. The insertion mechanism of claim 11, wherein the small coaxial gear of the second gear stack is configured to engage with both the third gear stack and the fourth gear stack.

13. The insertion mechanism of claim 11, wherein the small coaxial gear of the second gear stack comprises: a first set of teeth extending along approximately half of a length of the small coaxial gear and configured to engage with the third gear stack; and a second set of teeth extending along approximately a full length of the small coaxial gear and configured to engage with the fourth gear stack.

14. The insertion mechanism of claim 13, wherein the second set of teeth on the single gear of the third gear stack are configured to engage with the first set of teeth on the small coaxial gear of the second gear stack to allow for continuous rotation of the third gear stack.

15. The insertion mechanism of claim 13, wherein the small coaxial gear of the second gear stack is offset from the single gear of the third gear stack such that the teeth on the second gear stack and the third gear stack are extended into a plane of the single gear of the fourth gear stack, wherein engagement of the fourth gear stack with the second gear stack and the third gear stack sequentially is configured to cause partial rotation forward, then rotation backward, of the drive arm.

16. The insertion mechanism of claim 13, wherein: the second gear stack and the third gear stack are configured to rotate continuously in opposite directions; and the fourth gear stack is configured to only rotate when meshed with either of the second set of teeth of the small coaxial gear of the second gear stack or the first set of teeth of the single gear of the third gear stack.

17. The insertion mechanism of claim 11 , wherein the large gear of the second gear stack comprises teeth around the entire circumference.

18. The insertion mechanism of claim 5, further comprising a trigger configured to compress the spring, wherein the trigger is configured to be moved to allow the spring to release, wherein when the spring releases it is configured to apply the force on the gear assembly to cause movement of the drive arm.

19. The insertion mechanism of claim 18, wherein: the trigger comprises a first end and a pivot point; a shape memory wire is configured to be coupled to the trigger; in a first position of the trigger, the first end of the trigger is configured to contact the catheter hub to compress the spring; and the shape memory wire is configured to change shape to move the trigger into a second position about the pivot point, wherein in the second position, the first end of the trigger does not contact the catheter hub to allow the spring to release.

20. The insertion mechanism of claim 19, wherein the shape memory wire is configured to be heated to change shape.

21. A drug delivery device, comprising: a reservoir for holding medicament; a plunger assembly to expel the medicament from the reservoir; a motor to drive the plunger assembly; a power source for the motor; and the insertion mechanism according to any one of claims 1-20, wherein a catheter of the insertion mechanism is fluidly connected to the reservoir to deliver the medicament from the reservoir to a patient.

22. An infusion delivery device, comprising: a reservoir for holding medicament; a plunger assembly to expel the medicament from the reservoir; a motor to drive the plunger assembly; a power source for the motor;an outlet; and an insertion mechanism, comprising: a torsion spring; a needle hub configured to carry a needle, wherein the needle hub is constrained to moving along a linear direction: a catheter hub configured to carry a catheter, wherein the catheter hub is configured to be constrained by the needle hub; and a drive arm coupled to the torsion spring at a first end of the drive arm and coupled to the needle hub at a second end of the drive arm, wherein: actuation of the torsion spring is configured to rotate the first end of the drive arm in a first direction; and rotation of the drive arm in the first direction is configured to move the needle hub in the linear direction toward the outlet and to move the needle hub in the linear direction away from the outlet.

23. The infusion delivery device of claim 22, wherein: a first stroke of the rotation of the drive arm in the first direction is configured to move the needle hub in the linear direction toward the outlet; and a second stroke of the rotation of the drive arm in the first direction is configured to move the needle hub in the linear direction away from the outlet.

24. The infusion delivery device of claim 23, wherein movement of the needle hub in the linear direction toward the outlet is configured to move the catheter hub in the linear direction toward the outlet.

25. The infusion delivery device of claim 24, wherein: movement of the needle hub in the linear direction toward the outlet is configured to deploy the needle from the outlet; and movement of the catheter hub in the linear direction toward the outlet is configured to deploy the catheter from the outlet.

26. The infusion delivery device of claim 24, wherein the catheter hub is configured to engage a latch such that the second stroke of rotation of the drive arm in the first direction does not result in movement of the catheter hub in the linear direction away from the outlet.

27. The infusion delivery device of claim 26, wherein the catheter hub comprises: a ramped surface configured to ride under the latch; and a detent configured to engage the latch such that the second stroke of rotation of the drive arm in the first direction does not result in movement of the catheter hub in the linear direction away from the outlet.

28. The infusion delivery device of claim 22, wherein: the insertion mechanism further comprises a linkage coupled to the torsion spring; and the first end of the drive arm is coupled to the linkage.

29. The infusion delivery device of claim 22, further comprising a rail, wherein the needle hub comprises a carriage configured to slide along the rail in the linear direction.

30. The infusion delivery device of claim 29, wherein the rail is configured to constrain the needle hub to motion in the linear direction.

31. The infusion delivery device of claim 29, wherein the second end of the drive arm is coupled to the carriage.

32. The infusion delivery device of claim 22, further comprising a track, wherein: the needle hub comprises a support configured to carry the needle; and the support is positioned within the track and is configured to slide along the track in the linear direction.

33. The infusion delivery device of claim 32, wherein the catheter hub is positioned within the track and is configured to slide along the track in the linear direction.

34. An insertion mechanism, comprising: a catheter hub having a catheter coupled thereto; a needle hub having a needle coupled thereto and positioned proximal of the catheter hub; a drive arm configured to actuate the needle hub and the catheter hub; and a drive mechanism configured to drive the drive arm to move in a first direction to cause the needle hub to push the catheter hub distally to achieve insertion of the needle and the catheter into tissue at an angle relative to a surface of the tissue, and to move the drive arm in a second direction opposite the first direction to cause the needle hub to move proximally to achieve retraction of the needle from the catheter.

35. The insertion mechanism of claim 34, wherein: the drive arm comprises a slot; and the needle hub comprises a pin, wherein the pin is received in the slot to attach the drive arm to the needle hub.

36. The insertion mechanism of claim 34, further comprising a latch, wherein: the latch comprises a tab having a cutout therein; the catheter hub comprises a boss; and during insertion of the needle and the catheter into the tissue, the catheter hub is configured to deflect the tab until the boss seats within the cutout of the tab, locking the catheter hub in place.

37. The insertion mechanism of claim 34, wherein the drive mechanism comprises: a gear assembly coupled to the drive arm and configured to move the drive arm in the first and second directions; and a spring configured to apply a force on the gear assembly to cause movement of the drive arm.

38. The insertion mechanism of claim 37, wherein the gear assembly comprises: a rack support having an upper rack and an opposed lower rack; and a pinion coupled to the drive arm and positioned on the rack support between the upper rack and the opposed lower rack, wherein the spring is configured to apply a force to the racksupport such that movement of the rack support allows the pinion to sequentially engage with the upper rack and the opposed lower rack, engagement between the upper rack and the pinion being configured to move the drive arm in the first direction and engagement between the opposed lower rack and the pinion being configured to move the drive arm in the second direction.

39. The insertion mechanism of claim 38, further comprising a spring support configured to support the spring, wherein the spring support is coupled to and substantially perpendicular to the rack support.

40. The insertion mechanism of claim 37, wherein the gear assembly comprises first and second partial bevel gears, the spring being configured to apply a force to rotate the first and second partial bevel gears such that the first and second partial bevel gears are configured to sequentially engage with the drive arm, engagement between the first partial bevel gear being configured to move the drive arm in the first direction and engagement with the second partial bevel gear being configured to move the drive arm in the second direction.

41. The insertion mechanism of claim 40, wherein the gear assembly further comprises: a shaft configured to rotate, having the first and second partial bevel gears positioned thereon; and a drive gear rigidly coupled to the drive arm, wherein the drive arm is meshed with the shaft.

42. The insertion mechanism of claim 41, wherein the gear assembly further comprises one or more spur gears configured to rotate the shaft.

43. The insertion mechanism of claim 37, wherein the gear assembly comprises a plurality of gear stacks coupled to the spring and the drive arm, the plurality of gear stacks comprising: a first gear stack coupled to the spring and comprising a single gear that includes teeth around an entire circumference of the single gear; a second gear stack comprising a large gear configured to mesh with the single gear of the first gear stack and a small coaxial gear;a third gear stack comprising a single gear that includes a first set of teeth around a portion of a circumference of the single gear of the third gear stack at a first end of the single gear of the third gear stack and a second set of teeth around an entire circumference of the single gear of the third gear stack at a second end of the single gear of the third gear stack; and a fourth gear stack coupled to the drive arm and comprising a single gear that includes teeth around an entire circumference of the single gear of the fourth gear stack, wherein: engagement between small coaxial gear of the second gear stack and the single gear of the fourth gear stack is configured to move the drive arm in the first direction; and engagement between the first set of teeth of the single gear of the third gear stack and the single gear of the fourth gear stack is configured to move the drive arm in the second direction.

44. The insertion mechanism of claim 43, wherein the small coaxial gear of the second gear stack is configured to engage with both the third gear stack and the fourth gear stack.

45. The insertion mechanism of claim 43, wherein the small coaxial gear of the second gear stack comprises: a first set of teeth extending along approximately half of a length of the small coaxial gear and configured to engage with the third gear stack; and a second set of teeth extending along approximately a full length of the small coaxial gear and configured to engage with the fourth gear stack.

46. The insertion mechanism of claim 45, wherein the second set of teeth on the single gear of the third gear stack are configured to engage with the first set of teeth on the small coaxial gear of the second gear stack to allow for continuous rotation of the third gear stack.

47. The insertion mechanism of claim 45, wherein the small coaxial gear of the second gear stack is offset from the single gear of the third gear stack such that the teeth on the second gear stack and the third gear stack are extended into a plane of the single gear of the fourth gear stack, wherein engagement of the fourth gear stack with the second gear stack and the third gear stack sequentially is configured to cause partial rotation forward, then rotation backward, of the drive arm.

48. The insertion mechanism of claim 45, wherein: the second gear stack and the third gear stack are configured to rotate continuously in opposite directions; and the fourth gear stack is configured to only rotate when meshed with either of the second set of teeth of the small coaxial gear of the second gear stack or the first set of teeth of the single gear of the third gear stack.

49. The insertion mechanism of claim 43, wherein the large gear of the second gear stack comprises teeth around the entire circumference.

50. The insertion mechanism of claim 37, further comprising a trigger configured to compress the spring, wherein the trigger is configured to be moved to allow the spring to release, wherein when the spring releases it is configured to apply the force on the gear assembly to cause movement of the drive arm.

51. The insertion mechanism of claim 50, wherein: the trigger comprises a first end and a pivot point; a shape memory wire is configured to be coupled to the trigger; in a first position of the trigger, the first end of the trigger is configured to contact the catheter hub to compress the spring; and the shape memory wire is configured to change shape to move the trigger into a second position about the pivot point, wherein in the second position, the first end of the trigger does not contact the catheter hub to allow the spring to release.

52. The insertion mechanism of claim 51, wherein the shape memory wire is configured to be heated to change shape.

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