Shift head inserter device associated with automatic insertion and retraction

Abstract

To provide an inserter device having an automatic insertion mechanism.SOLUTION: In an inserter device 10 having an automatic insertion mechanism, the automatic insertion mechanism shifts an injection head 601 and a needle assembly 300 to an insertion constitution in which a cannula 602 of the injection head and an introduction needle 304 of the needle assembly 300 are automatically inserted into a patient's skin, from a storage constitution. The inserter device 10 also includes an automatic retraction mechanism. The automatic retraction mechanism shifts the needle assembly 300 to a retraction constitution in which the introduction needle 304 is removed from the patient's skin.SELECTED DRAWING: Figure 3

Description

[Technical field]

[0001] The present disclosure relates to drug infusion systems, and more particularly to an inserter device that can be used to insert a cannula into the subcutaneous space of a patient, and methods of use thereof. [Background technology]

[0002] Infusion sets are used to deliver medications to the subcutaneous space of a patient. The head assembly of the infusion set has a fluid pathway in the form of a stainless steel needle or soft cannula that must be inserted to the correct depth into the subcutaneous tissue. To insert the soft cannula, a stainless steel introducer needle is used. The introducer needle pierces the tissue to allow the cannula to enter and provides rigidity to the cannula during insertion. After insertion, the introducer needle is removed.

[0003] Insertion and removal of the introducer needle constitute a separate step that can be performed manually by the patient or automated by the inserter. Most commercially available inserters automate the insertion of the introducer needle. After insertion, the introducer needle is typically manually withdrawn.

[0004] Another important consideration is component movement during insertion. Most inserters are "shift head" devices 1000, where the fluid path 1602 is irreversibly coupled to the injection head 1601 and moves with the injection head 1601 during the insertion process as an integrated injection head assembly 1600 (FIG. 1). In contrast, other inserters are "shift fluid path" devices 2000, where the fluid path 2602 starts separate from the injection head 2601 and advances toward and joins the injection head 2601 during the insertion process (FIG. 2).

[0005] The "shift head" device 1000 (FIG. 1), in which the fluid path 1602 is an integral part of the injection head assembly 1600, is mechanically robust because the entire injection head assembly 1600 moves as a single piece and does not require snaps or latches. Shifting the entire injection head assembly 1600 also means that there are no gaps between components through which water can enter. Eliminating water ingress reduces the risk of infection. In contrast, with the "shift fluid path" device 2000 (FIG. 2), the injection head 2601 and adhesive patch are first applied to the skin when the patient places the device 2000 on their skin. When the patient or the patient's caregiver activates the device 2000, the fluid path 2602 shifts towards the skin and latches to the injection head 2601. Because the larger adhesive patch and injection head 2601 are initially attached to the skin, the "shift fluid path" device 2000 can be made smaller and more compact. However, the increased number of components and dynamic interfaces required increases mechanical complexity. The latching of the fluid path 2602 to the injection head 2601 must also be controlled to minimize undesirable tears near the insertion site. The clip that captures the fluid path 2602 must also have some tolerance so that the fluid path 2602, even if captured correctly, may wobble slightly within the clip, potentially causing discomfort. Overall, the "shift head" device 1000 offers several advantages over the "shift fluid path" device 2000.

[0006] It would be desirable to have an inserter device that provides both automatic insertion and automatic retraction of an introducer needle to minimize patient discomfort, reduce user error, and provide as painless an insertion experience as possible. Additionally, it would be desirable to have an inserter device that shifts the entire injection head assembly rather than the fluid path to ensure mechanical robustness. It is therefore an object of the present invention to provide an inserter device that provides both automatic insertion and automatic retraction of an introducer needle while shifting the entire injection head assembly. Summary of the Invention

[0007] The present disclosure relates to an inserter device having an automatic insertion mechanism that shifts an injection head and needle assembly from a stowed configuration to an insertion configuration in which an introducer needle of the injection head cannula and needle assembly is inserted into a patient's skin. The inserter device also includes an automatic retraction mechanism that automatically shifts the needle assembly to a retracted configuration in which the introducer needle is removed from the patient's skin.

[0008] In accordance with an exemplary embodiment of the present disclosure, an inserter device is disclosed that includes a housing, an actuator, an injection head including a cannula, a push plate removably coupled to the injection head, a needle assembly including an introducer needle, an insertion mechanism configured to automatically move the injection head, the push plate, and the needle assembly in response to movement of the actuator from a stored configuration in which the cannula and introducer needle are positioned within the housing to an insertion configuration in which the cannula and introducer needle extend from the housing, and a retraction mechanism configured to automatically move the needle assembly from the insertion configuration to a retracted configuration in which the introducer needle is positioned within the housing.

[0009] In accordance with another exemplary embodiment of the present disclosure, an inserter device is disclosed that includes a housing, an actuator, an injection head including a cannula, a push plate removably coupled to the injection head, a needle assembly including an introducer needle, an automatic insertion mechanism, and a shift plate having a storage configuration, where the automatic insertion mechanism loads against the shift plate with the injection head and the needle assembly positioned within the housing, an insertion configuration, where the automatic insertion mechanism moves the shift plate, the injection head, the push plate, and the needle assembly relative to the housing, and the cannula and introducer needle extend from the housing, and an intermediate configuration, where the automatic insertion mechanism moves the shift plate relative to the injection head, the push plate, and the needle assembly. [Brief description of the drawings]

[0010] The above and other features and advantages of the present disclosure, and the manner in which they are accomplished, will become more apparent and be better understood by reference to the following description of embodiments of the invention taken in conjunction with the accompanying drawings.

[0011] [Figure 1] FIG. 1 is a schematic diagram of a prior art inserter device for shifting an infusion set head. [Diagram 2] FIG. 1 is a schematic diagram of a prior art inserter device for shifting a cannula. [Diagram 3] FIG. 2 is an exploded view of one embodiment of the present inserter. [Figure 4] FIG. 4 is a perspective view of a lower housing of the inserter device of FIG. 3. [Diagram 5] FIG. 4 is a perspective view of an upper housing of the inserter device of FIG. 3. [Figure 6] FIG. 4 is a perspective view of a carriage of the inserter device of FIG. 3. [Figure 7] FIG. 4 is a perspective view of a needle assembly of the inserter device of FIG. 3. [Figure 8] FIG. 4 is a perspective view of a shift plate of the inserter device of FIG. 3. [Figure 9] FIG. 4 is a perspective view of a push plate of the inserter device of FIG. 3. [Figure 10] FIG. 4 is a perspective view of an injection head assembly of the inserter device of FIG. 3. [Figure 11] FIG. 4 is a perspective view of a safety assembly of the inserter device of FIG. 3. [Figure 12] 4 is a cross-sectional view of the inserter device of FIG. 3 in a stored configuration with the safety assembly in a locked configuration, the cross-section being taken along direction L. [Figure 13] FIG. 4 is a partial perspective view of the inserter device of FIG. 3 in a stored configuration with the safety assembly in a locked configuration. [Figure 14] FIG. 4 is a partial perspective view of the inserter device of FIG. 3 in a trigger configuration with the safety assembly in an unlocked configuration. [Figure 15] 4 is a cross-sectional view of the inserter device of FIG. 3 in a trigger configuration just prior to needle insertion, the cross-section being parallel to direction L. [Figure 16] FIG. 16 is a cross-sectional view of the inserter device of FIG. 3 in the same trigger configuration as seen in FIG. 15, the cross-section being taken along direction W. [Figure 17] 4 is a cross-sectional view of the inserter device of FIG. 3 in an insertion configuration after needle insertion but before retraction, the cross-section being parallel to direction L. FIG. [Figure 18] 18 is a cross-sectional view of the inserter device of FIG. 3 in the same insertion configuration as seen in FIG. 17, the cross-section being taken along direction W. [Figure 19] FIG. 4 is a partial cross-sectional perspective view of the inserter device of FIG. 3 in an insertion configuration, showing the head lock in a locked position. [Figure 20] 4 is a partial cross-sectional perspective view of the inserter device of FIG. 3 in an intermediate configuration, showing the head lock in an unlocked position. FIG. [Figure 21] 4 is a cross-sectional view of the inserter device of FIG. 3 in an intermediate configuration immediately prior to retraction, the cross-section being parallel to direction L. FIG. [Figure 22] 22 is a cross-sectional view of the inserter device of FIG. 3 in the same intermediate configuration as seen in FIG. 21, the cross-section being taken along direction W. [Diagram 23] 4 is a cross-sectional view of the inserter device of FIG. 3 in a retracted configuration, the cross-section being parallel to direction L. [Figure 24] FIG. 24 is a cross-sectional view of the inserter device of FIG. 3 in the same retracted configuration as seen in FIG. 23, the cross-section being taken along direction W. [Diagram 25] FIG. 4 is a top perspective view of the inserter device of FIG. 3 with the upper housing removed. [Figure 26] 4 is a cross-sectional view of the inserter device of FIG. 3 showing the housing guide, the cross-section being taken along direction L. [Figure 27] 4 is a cross-sectional view of the inserter device of FIG. 3 showing the housing guide, the cross-section being parallel to direction W. FIG. [Figure 28] FIG. 13 is an exploded view of an embodiment of the present inserter device including a holder. [Figure 29] FIG. 29 is a cross-sectional view of the inserter device of FIG. 28, the cross-section being taken along direction L. [Diagram 30] FIG. 30 is a partial cross-sectional view of the inserter device of FIG. 28 showing the carriage, clip holder, and holder in a locked configuration. [Diagram 31] FIG. 30 is a partial cross-sectional view of the inserter device of FIG. 28 showing the carriage, clip holder, and holder in an unlocked state.

[0012] Corresponding reference characters indicate corresponding parts throughout the several views. The illustrations set forth herein illustrate exemplary embodiments of the present invention, and such illustrations should not be construed as limiting the scope of the present invention in any manner. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0013] To promote an understanding of the principles of the invention, reference will now be made to the embodiments illustrated in the drawings and specific language will be used to describe the same. It will be understood, however, that no limitation of the scope of the invention is intended thereby. Any alterations and further modifications in the described embodiments, and further applications of the principles of the invention disclosed herein, as would normally occur to one skilled in the art to which the invention pertains, are contemplated. Although one embodiment of the invention has been shown in great detail, it will be apparent to one skilled in the art that for purposes of clarity, certain features not relevant to the invention have not been shown.

[0014] An exemplary inserter device 10 of the present disclosure is shown in FIG. 3. The inserter device 10 has a length measured along axis L and a width measured along axis W. The inserter device 10 of FIG. 3 includes a housing 100 including an upper housing 120 and a lower housing 130, a carriage 200 that doubles as an actuator in the form of a button 201, a needle assembly 300, a shift plate 400, a push plate 500, an injection head assembly 600, and a safety assembly 700. During use, the inserter device 10 provides both automatic insertion and automatic retraction of the needle assembly 300. The inserter device 10 automatically inserts and retracts the needle assembly 300 by shifting the injection head assembly 600 to insert a cannula 602 into the skin of a patient. The cannula 602 is then used to deliver a medication (not shown) to the skin of a patient. Each element of the inserter device 10 is further described below.

[0015] The lower housing 130 is shown in Figure 4 and the upper housing 120 is shown in Figure 5. The lower housing 130 and the upper housing 120 are joined along a housing interface 108 to retain the other elements of the inserter device 10. In the illustrated embodiment, the lower housing 130 includes a snap 110 and the upper housing 120 includes a corresponding latch 111, although this configuration may vary.

[0016] 4 illustrates a lower housing 130 including an operating channel 117 and a number of guide slots, illustratively guide slots 102A, 102B, 102C, 102D. The guide slots 102A, 102B, 102C, 102D are defined by grooves or notches in the walls surrounding the operating channel 117. The guide slots 102A, 102B, 102C, 102D are spaced around the circumference of the operating channel 117 such that the guide slots 102A and 102B are located toward the rear of the inserter device 10 and the guide slots 102C and 102D are located toward the front of the inserter device 10.

[0017] As shown in FIG. 4, the lower housing 130 also includes a shift plate catch 118. The shift plate catch 118 is located near the top end of the operating channel 117. The shift plate catch 118 extends horizontally inwardly from a wall surrounding the operating channel 117 toward the center of the operating channel 117. In use, the shift plate catch 118 is configured to catch a portion of the shift plate 400 and prevent it from backing out after actuation of the inserter device 10 (FIG. 21). Operation of the inserter device 10 is discussed further below.

[0018] 4, the lower housing 130 further includes a safety seat 127 configured to receive the safety assembly 700 (FIG. 3). The safety seat 127 includes an elongated opening at the bottom of the lower housing 130 and widens as it extends upwardly into the lower housing 130.

[0019] 5 shows upper housing 120 including central core 103 and guide slots 104A, 104B. Central core 103 extends vertically downward and is configured to guide and facilitate only vertical movement of needle assembly 300 (FIG. 3). Guide slots 104A, 104B extend vertically downward and are configured to slidably receive push plate 500 (FIG. 3).

[0020] As shown in Figure 5, the top housing 120 is configured to accommodate the carriage 200 (Figure 3). The top housing 120 includes a button opening 129 that is sized and configured to allow a button 201 of the carriage 200 to extend partially out of the top housing 120 and be pressed further into the button opening 129. The top housing 120 also includes a rear carriage return wall 101.

[0021] 5, the top housing 120 also includes a carriage slot 125. The carriage slot 125 is disposed along an inner wall of the top housing 120. The carriage slot 125 extends horizontally into the top housing 120 and is configured to suspend and slidably retain the carriage 200 through the pushing and resilient movements involved in actuation of the inserter device 10. The carriage slot 125 extends horizontally into the top housing 120 far enough to provide a substantially straight horizontal sliding path for the carriage 200 along the length L of the inserter device 10 (FIG. 3).

[0022] 5, the upper housing 120 includes a safety post 126 configured to support a safety assembly 700 (FIG. 3). The safety post 126 flares as it extends vertically downward from the upper housing 120 and cooperates with the above-mentioned safety seat 127 in the lower housing 130 (FIG. 4). The operation of the safety assembly 700 is discussed further below.

[0023] FIG. 6 shows the carriage 200 of the inserter device 10. The button 201 of the carriage 200 extends into the button opening 129 of the upper housing 120 (FIG. 5). The button 201 is functionally shaped to ergonomically fit the patient's finger or thumb. The carriage 200 may be molded so that the button 201 is configured to shift the entire carriage 200 when pressed into the housing 100 (FIG. 3). As shown in FIG. 6, the carriage also includes a tab 204. The tab 204 is configured to engage with the button catch 109 of the upper housing 120 (FIG. 5) when the button 201 is pressed and shifted into the upper housing 120. In this way, the tab 204 limits the movement of the button 201 and prevents the button 201 from being pressed into the upper housing 120 until it interferes with other features of the inserter device 10. FIG. 6 also shows a carriage return spring 202 of the carriage 200. The carriage return spring 202 can be a cantilever arm or any other biasing system known in the art. The carriage return spring 202 is located on the opposite side of the carriage 200 from the button 201 and is configured to engage the rear carriage return wall 101 of the upper housing 120 (FIG. 5).

[0024] As shown in Figure 6, the carriage 200 also includes one or more safety catches 203 and one or more shift plate catches 205 (one of which is hidden from view). Figure 6 shows that the safety catch 203 is a stepped flange that extends inwardly from the carriage 200. Figure 6 also shows that the shift plate catch 205 includes a flat portion 205A that extends forwardly inwardly from the carriage 200 towards the button 201, and a vertical portion 205B that also extends vertically upwardly inwardly from the carriage 200.

[0025] 6, the carriage 200 also includes rails 207A and 207B. The rails 207A and 207B are slidably received within the carriage slot 125 of the upper housing 120 (FIG. 5). The rails 207A and 207B and the carriage slot 125 are configured to suspend the carriage 200 within the housing 100 such that the carriage 200 does not interfere with any other features of the inserter device 10 while allowing the carriage 200 to shift horizontally along the length L of the housing 100 (FIG. 3) to actuate the inserter device 10.

[0026] FIG. 7 shows the needle assembly 300 of the inserter device 10. The needle assembly 300 is comprised of three main components: a needle head 301, an introducer needle 304 that extends through the needle head 301, and a needle hub 305 that supports the needle head 301. In FIG. 7, the needle hub 305 is shown to have a circular slot 302 that is substantially uniform in diameter and extends downwardly along the length of the needle hub 305. The circular slot 302 is sized and configured to receive the central core 103 of the upper housing 120 (FIG. 5). At the top of the circular slot 302, the needle hub 305 also has a shoulder 314 that extends radially outward. Extending vertically downwardly from the shoulder 314 are snap arms 306. Each snap arm 306 includes an inner push plate lip 307 and an outer shift plate lip 308. The snap arms 306 are configured to be semi-flexible and resilient. As shown in FIG. 7, the needle hub 305 includes a spring catch 309 located under a shoulder 314 around the circular slot 302. The spring catch 309 extends radially outward from the needle hub 305 and can span the circumference of the needle hub 305 or can be separate extensions spaced apart around the circumference of the needle hub 305. Finally, the needle hub 305 also includes a needle head gripper 311. The needle head gripper 311 includes an arm 312 that extends further downwardly and is semi-flexible and resilient to aid in assembly. At the end of the arm 312 is a catch 313 configured to engage the needle head 301 to retain the needle head 301 during insertion and retraction.

[0027] 7, the needle head 301 and introducer needle 304 are held horizontally in place by needle head gripper 311. Needle head gripper 311 engages needle head 301 through gripping slot 303. Gripping slot 303 is sized and configured to receive catch 313. The top surface of needle head 301 is sloped so that during assembly, needle head 301 is forced up into the space between arms 312. As needle head 301 is forced into arms 312, arms 312 bend outward and then snap catch 313 snaps into place in gripping slot 303.

[0028] FIG. 8 shows the shift plate 400 of the inserter device 10. As FIG. 8 shows, the shift plate 400 is a substantially circular component and includes tabs 401 protruding from either side of the shift plate 400. The shift plate 400 also includes a needle hub catch 402. The needle hub catch 402 extends radially inward from the shift plate 400 to form a platform. The bottom of the shift plate 400 forms a bottom platform 403 (see also FIG. 15). The bottom platform 403 extends all the way around the shift plate 400. Immediately above the bottom platform 403 is a spring receiving slot 404, which is a U-shaped cavity, the bottom of which is opposite the bottom platform 403.

[0029] 8, the shift plate 400 also includes a headlock engagement arm 405. The headlock engagement arm 405 extends radially inward from the shift plate 400 and includes an angled wedge 406 at its innermost end. Beneath the headlock engagement arm 405 is an angled receiver 407 (see also FIG. 19) that extends radially inward from the shift plate 400 below the headlock engagement arm 405, and a headlock receiving slot 408. FIG. 8 also shows a retaining clip 409 on the shift plate 400. The retaining clip 409 is semi-flexible and configured to be biased inward until the shift plate 400 has moved fully down, at which point the retaining clip 409 is released to snap under the shift plate catch 118 on the lower housing 130 (FIG. 4) to lock the position of the shift plate 400. To facilitate only vertical movement and prevent lateral or horizontal movement due to operation of the inserter device 10, the shift plate 400 also includes guide rails 411A, 411B, 411C, 411D.

[0030] FIG. 9 illustrates the push plate 500 of the inserter device 10. The push plate 500 includes a needle hub catch 501 that engages with a snap arm 306 of the needle hub 305 (FIG. 7) to pinch the snap arm 306 between the needle hub catch 501 and the needle hub catch 402 (FIG. 8). As shown in FIG. 9, the push plate 500 also includes one or more biasing arms 502. The biasing arms 502 are disposed along the bottom surface of the push plate 500 and are configured to be biased upwards but pushed downwards. The biasing arms 502 in this embodiment are cantilever arms, but may alternatively be springs or any other biasing means known in the art. With momentary reference to FIG. 16, the push plate 500 also includes an injection head cavity 508 and a needle head opening 507. Injection head cavity 508 is a rounded cavity on the underside of push plate 500 configured to receive injection head assembly 600. Needle head opening 507 is an opening at the top of injection head cavity 508 that allows needle 304 to extend beyond push plate 500 while needle head 301 is placed on top of push plate 500.

[0031] Returning to FIG. 9, to facilitate only vertical movement and prevent horizontal movement or wobble, the push plate 500 also includes outwardly directed guide rails 504A, 504B, 504C, 504D that are sized and configured to be received in corresponding guide slots 102A, 102B, 102C, 102D of the lower housing (FIG. 4). The guide rails 504A, 504B, 504C, 504D also include inwardly directed guide slots 505A, 505B, 505C, 505D that are sized and configured to receive corresponding guide rails 411A, 411B, 411C, 411D of the shift plate 400 (FIG. 8). The push plate 500 further includes guide posts 506A, 506B that extend vertically upward and are slidably received in corresponding guide slots 104A, 104B of the upper housing 120 (FIG. 5).

[0032] 12 shows the retraction mechanism in the form of a retraction spring 112 of the inserter device 10, and the automatic insertion mechanism in the form of an insertion spring 113. The retraction spring 112 is disposed around the needle hub 305 and engages at its lower end with the top surface of the injection head cavity 508 of the push plate 500 and at its upper end with the spring catch 309 (FIG. 16). The insertion spring 113 is disposed at its lower end around and within the spring receiving slot 404 of the shift plate 400 and engages at its upper end with the top surface of the upper housing 120.

[0033] FIG. 10 shows the injection head assembly 600 of the inserter device 10. The injection head assembly 600 is comprised of an injection head 601, a cannula 602, and a needle cavity 605. The injection head 601 is the main body of the injection head assembly 600 and is shaped and configured to be received in the injection head cavity 508 of the push plate 500 (FIG. 12). The needle cavity 605 is a hole in the injection head 601 that is shaped and configured to receive the introducer needle 304 (FIG. 12), allowing the introducer needle 304 to extend through the injection head 601 and into the cannula 602. The cannula 602 is a flexible thin tube that receives the introducer needle 304 during insertion and extends into the patient's skin to administer the drug. The injection head 601 also includes a channel 603 that is sized and configured to slidably receive the head lock 612. The channel 603 is defined by a lip 604 on at least the upper boundary of the channel 603, which is configured to suspend and attach the injection head assembly 600 to the push plate 500 until the insertion operation of the inserter device 10 is completed, as described further below.

[0034] 10, the head lock 612 includes a forward facing injection head locking arm 613, a rearward facing push plate engagement arm 615, and a bracket 614 connecting the injection head locking arm 613 and the push plate engagement arm 615. The injection head locking arm 613 extends into the channel 603 and engages the lip 604. As will be further described below, the push plate engagement arm 615 extends into and locks into the push plate 500 (FIG. 9) to lock the injection head assembly. The push plate engagement arm 615 includes an angled surface 616 to facilitate engagement of the shift plate 400 (FIG. 8) and unlocking of the head lock 612.

[0035] 11 illustrates a safety assembly 700 of the inserter device 10 configured to prevent accidental actuation of the inserter device 10. The safety assembly 700 includes a spring 701 disposed within the safety post 126 of the upper housing 120 (FIG. 5) and a safety device 702 (see also FIGS. 13 and 14). The safety device 702 is comprised of a long vertical rod 703 disposed partially within the safety post 126 of the upper housing 120 (FIG. 5) and extending through the safety seat 127 of the lower housing 130 (FIG. 4). The rod 703 includes a tab 704 near its upper end and a side wall 705 that engages the safety catch 203, as described further below, to prevent accidental depression of the button 201 by preventing horizontal movement of the carriage 200 (FIG. 6). The rod 703 also includes a longitudinal rib 706 that rests suspended on the safety seat 127 of the housing 100 to retain the safety assembly 700 within the housing 100 (FIG. 12).

[0036] The operation of the inserter device 10 will now be described with reference to FIGS.

[0037] 12 and 13, the inserter device 10 is provided in a stored configuration with the safety assembly 700 in a locked configuration with the safety 702 preventing translational movement of the carriage 200. The lower end of the rod 703 projects below the housing 100 and a tab 704 on the upper end of the rod 703 engages with a safety catch 203 on the carriage 200 to prevent horizontal movement of the carriage 200. Similarly, the tab 401 on the shift plate 400 engages with a shift plate catch 205 on the carriage 200 to hold the shift plate 400, push plate 500, needle assembly 300, and injection head assembly 600 in place and compress the insertion spring 113. In this stored configuration, the needle assembly 300 is elevated and hidden within the housing 100 to prevent contact with the patient or the patient's caregiver. Additionally, the carriage return spring 202 engages with the carriage return wall 101 of the upper housing 120 to prevent sagging of the button 201 due to tolerances and provide a higher quality feel to the user.

[0038] 14, the safety assembly 700 is shown in an unlocked configuration with the safety 702 pushed up in direction A1 (FIG. 13), such as by contact with a patient's skin. This pushing action disengages the wall 705 of the tab 704 from the safety catch 203, allowing the carriage 200 to translate rearward in direction A2 (FIG. 13). FIG. 14 also shows the inserter device 10 in a triggered configuration with the carriage 200 translated in direction A2 in response to depression of the button 201. This triggering action disengages the tab 401 of the shift plate 400 from interference with the shift plate catch 205 of the carriage 200, allowing the shift plate 400, push plate 500, needle assembly 300, and injection head assembly 600 to translate vertically downward under the influence of the insertion spring 113 (FIGS. 15-18). When the button 201 on the carriage 200 is pressed, the carriage return spring 202 is compressed against the carriage return wall 101 of the upper housing 120, and the deflection provides a return force to return the carriage 200 to its initial position after the button 201 (not shown) is released.

[0039] 15 and 16, the inserter device 10 is shown in the trigger configuration immediately after the carriage 200 has translated, but before insertion begins. The needle hub 305, shift plate 400, and push plate 500 are held together via snap arms 306 on the needle hub 305, which is sandwiched between the shift plate 400 and the push plate 500, as shown in FIG. 16. The inwardly facing push plate lip 307 engages the needle hub catch 501 on the push plate 500. The outwardly facing shift plate lip 308 engages the needle hub catch 402 on the shift plate 400. This sandwiching of the needle hub 305 between the shift plate 400 and the push plate 500 locks these components together onto the carriage 200. This lock also prevents the needle hub 305 from retracting before insertion is complete.

[0040] 17 and 18, the inserter device 10 is shown in an insertion configuration. The insertion spring 113 pushes the push plate 500, the shift plate 400, the needle assembly 300, and the injection head assembly 600 downward together through the carriage 200. This downward movement continues until the push plate 500 reaches the surface to which the injection head 601 is being applied (typically the insertion site on the patient's body). In this insertion configuration, the introducer needle 304 and the cannula 602 protrude from the housing 100 into the patient's skin, and the injection head 601 contacts and adheres to the patient's skin. The biasing arm 502 continues to momentarily hold the shift plate 400 by a distance D, so that the snap arm 306 of the needle hub 305 remains pinched between the shift plate 400 and the push plate 500, thereby preventing the snap arm 306 from springing outward to release the needle assembly 300. The push plate 500 can interact with the housing 100 to remain locked in the insertion configuration.

[0041] 21 and 22, the inserter device 10 is shown in an intermediate configuration. As the shift plate 400 continues to translate downward relative to the push plate 500 over a distance D (FIG. 17), the insertion spring 113 overcomes the force of the biasing arm 502 of the push plate 500 and presses the shift plate 400 against the push plate 500. During this relative movement, the shift plate 400 continues to pass the needle assembly 300, which unlocks the snap arms 306 of the needle hub 305, which become free to flex upward and outward in direction A4, thereby releasing the needle assembly 300 from the other components. The retraction spring 112 is then free to drive the needle assembly 300 upward in direction A5, as will be further described below. The shift plate 400 and push plate 500 may be held in this intermediate configuration based on the continuing force from the insertion spring 113 and / or the interaction between the retaining clip 409 of the shift plate 400 and the shift plate catch 118 of the lower housing 130.

[0042] Advantageously, the shift plate 400 may cause the retraction of the introducer needle 304 regardless of the final position of the push plate 500 based solely on the relative movement between the shift plate 400 and the push plate 500. For example, even if the push plate 500 rests on a skin ridge in the insertion configuration without reaching the bottom surface of the housing 100, the shift plate 400 will continue to move downwards and release the introducer needle 304 once it reaches the intermediate configuration. The biasing arm 502 may also help to dampen the impact of the shift plate 400 against the push plate 500. The stiffness of the biasing arm 502 may be adjusted (e.g., by making the cantilever beam thicker or thinner) to control this relative movement between the shift plate 400 and the push plate 500. Despite these advantages of the shift plate 400, for example, it is within the scope of this disclosure to eliminate the shift plate 400 in certain embodiments and release the needle assembly 300 based on the position of the push plate 500.

[0043] As shown in Figures 19 and 20, the shift plate 400 interacts with the head lock 612 to release the injection head 601 from the inserter device 10. The angled wedge 406 of the shift plate 400 engages the head lock 612 as the shift plate 400 is shifted downward from the insertion configuration of Figure 19 to the intermediate configuration of Figure 20. This engagement pulls the head lock 612 rearward toward the shift plate 400 in the direction A3. Finally, when the shift plate 400 bottoms out in the intermediate configuration of Figure 20, the head lock 612 is received within the head lock receiving slot 408, which is sized to fit the head lock 612. The final downward position of the angled wedge 406 holds the head lock 612 in a rearward position and prevents free movement of the head lock 612.

[0044] 23 and 24 show the inserter device 10 in a retracted configuration after the needle hub 305 and introducer needle 304 have been retracted into the housing 100 by the action of the retraction spring 112. In this retracted configuration, the inserter device 10 may be comfortably lifted off the patient's skin. As described above, with the injection head 601 attached to the patient's skin and the head lock 612 separated from the injection head 601, the injection head 601 and cannula 602 are separated from the inserter device 10 and remain attached to the patient's skin.

[0045] The inserter device 10 can be designed to ensure that the introducer needle 304 enters the tissue perpendicular and perpendicular to the surface of the patient's skin with minimal rotational, horizontal, or wobble motion to ensure patient comfort. Various alignment features are shown in FIG. 25, including guide slots 102A, 102B, 102C, 102D (see also FIG. 4) on the lower housing 130 that interact with corresponding guide rails 504A, 504B, 504C, 504D on the push plate 500 (see also FIG. 9) and guide slots 505A, 505B, 505C, 505D that interact with corresponding guide rails 411A, 411B, 411C, 411D on the shift plate 400 (see also FIG. 8). These alignment features engage with each other throughout the vertical translation of the injection head assembly 600. Additional alignment features are shown in Figures 26 and 27, including a central core 103 of the upper housing 120 in which the needle hub 305 is concentrically seated, and guide slots 104A, 104B of the upper housing 120 which interact with guide posts 506A, 506B of the push plate 500.

[0046] Another exemplary inserter device 10' is shown in Figures 28-31. The inserter device 10' is similar to the inserter device 10 described above, with like reference numbers identifying like elements, except as described below.

[0047] The inserter device 10' is configured to insert the introducer needle 304' and / or the cannula 602' of the injection head 601' into the subcutaneous space of the patient and also allows for the application of an optional holder 607'. The holder 607' can be applied together with the injection head 601' or in a subsequent step by aligning a previously inserted injection head 601' with the push plate 500' to control the position of the holder 607'. The inserter device 10' is part of a system that allows drug delivery devices such as pumps or bolus syringes (not shown) to be interchangeably mounted either in a patch modality coupled to the holder 607' or in a tethered modality without the holder 607', as described in International Application PCT / US2020 / 023825, filed March 20, 2020, the disclosure of which is expressly incorporated herein by reference in its entirety.

[0048] A cross section of the assembled inserter device 10' is shown in Figure 29. The housing 100' includes a holder receptacle 606' shaped and sized to nest with a holder 607'. The holder 607' includes an adhesive backing 609' configured to adhere to the patient's skin.

[0049] As shown in Figures 30 and 31, the housing 100' also includes a holder snap 107'. The holder snap 107' is located toward the rear of the housing 100'. The holder snap 107' is a semi-flexible extension of the housing 100' that reversibly engages with a snap receiver 611' of the holder 607' in a snap-fit ​​lock. In the stored configuration of Figure 30, the snap blocker 206' is positioned directly adjacent to the holder snap 107', thus forcing the holder snap 107' into contact with the snap receiver 611' and preventing movement of the holder 607'. The holder snap 107' is configured to be released from its snap-fit ​​engagement with the snap receiver 611' upon depression of the button 201'. When the button 201' is pressed and the carriage 200' is translated to the trigger configuration of Fig. 31, the snap blocker 206' also translates out of interference with the holder snap 107', thus allowing the holder snap 107' to be released from the snap receiver 611'. In a preferred embodiment, the holder snap 107' has only a light retention force, so that the force of the adhesive backing 609' (Fig. 29) of the holder 607' on the skin is sufficient to pull the holder 607' out of the inserter device 10'.

[0050] Further embodiments and variations of the above disclosure are possible. For example, the inserter device 10 shown uses two compression springs 112, 113 to drive the insertion and retraction of the introducer needle 304. However, other motive forces may be envisioned. For example, in some embodiments, the compression springs 112, 113 may be combined into a double-wound spring. In other embodiments, the compression springs 112, 113 may be eliminated and a scotch yoke, slider crank, torsion spring, or cam-based mechanism may be used to store energy for the insertion and retraction of the introducer needle 304.

[0051] Similarly, the embodiments described thus far use a safety assembly 700 that is released by applying the inserter device 10 to the patient's body. This action pushes up a safety 702, allowing forward movement of the carriage 200. However, the safety assembly 700 may take other forms. This may be accomplished by a button or sliding mechanism, or any of a variety of other mechanical mechanisms known in the art. In one embodiment, no safety is used.

[0052] While the invention has been described as having an exemplary design, the invention can be further modified within the spirit and scope of the disclosure. This application is therefore intended to cover any variations, uses, or adaptations of the invention using its general principles. Further, this application is intended to cover such departures from the disclosure as come within known or customary practice in the art to which this invention pertains and which fall within the limits of the appended claims.

Claims

1. 1. An inserter device comprising: Housing and An actuator; an injection head including a cannula; a push plate removably coupled to the injection head; a needle assembly including an introducer needle; an insertion mechanism configured to automatically move the injection head, the push plate, and the needle assembly in response to movement of the actuator from a stored configuration, in which the cannula and the introducer needle are positioned within the housing, to an insertion configuration, in which the cannula and the introducer needle extend from the housing; and a retraction mechanism configured to automatically move the needle assembly from the insertion configuration to a retracted configuration in which the introducer needle is positioned within the housing.

2. The inserter device of claim 1 , wherein the insertion mechanism is an insertion spring and the retraction mechanism is a retraction spring.

3. The inserter device of claim 2 , wherein the insertion spring surrounds the retraction spring.

4. In the stored configuration, both the insertion spring and the retraction spring are loaded; in the insertion configuration, the insertion spring is unloaded and the retraction spring is loaded; The inserter device of claim 2 , wherein in the retracted configuration, both the insertion spring and the retraction spring are unloaded.

5. The inserter device of claim 1 , wherein the retraction mechanism moves the needle assembly to the retracted configuration regardless of the location of the push plate relative to the housing.

6. Further comprising a shift plate, In the stored configuration, the needle assembly is captured between the shift plate and the push plate; In the insertion configuration, the needle assembly is captured between the shift plate and the push plate; The inserter device of claim 1 , wherein in an intermediate configuration between the insertion configuration and the retracted configuration, the shift plate releases the needle assembly from the push plate.

7. 7. The inserter device of claim 6, wherein the push plate includes at least one flexible member that is biased upwardly in the insertion configuration and that is forced downwardly under the shift plate in the intermediate configuration.

8. 7. The inserter device of claim 6, further comprising a headlock, the headlock coupling the injection head to the push plate in the stored configuration and the insertion configuration, and releasing the injection head from the push plate in the intermediate configuration.

9. The inserter device of claim 1 , further comprising a headlock, the headlock coupling the injection head to the push plate in the stowed configuration and releasing the injection head from the push plate prior to the retracted configuration.

10. 10. The inserter device of claim 1, further comprising a holder configured for use with the injection head in a patch modality, the holder configured to be released from the housing in response to movement of the actuator.

11. 1. An inserter device comprising: Housing and An actuator; an injection head including a cannula; a push plate removably coupled to the injection head; a needle assembly including an introducer needle; An automatic insertion mechanism; A shift plate, a stored configuration, wherein the automatic insertion mechanism is loaded against the shift plate with the injection head and the needle assembly positioned within the housing; and an insertion configuration, wherein the automated insertion mechanism moves the shift plate, the injection head, the push plate, and the needle assembly relative to the housing such that the cannula and the introducer needle extend from the housing; and an inserter device comprising: a shift plate having an intermediate configuration, wherein the automatic insertion mechanism moves the shift plate relative to the injection head, the push plate, and the needle assembly.

12. The inserter device of claim 11 , further comprising a carriage supporting the actuator, the carriage restraining the shift plate in the stored configuration and releasing the shift plate in the insertion configuration.

13. 13. The inserter device of claim 12, wherein between the storage configuration and the insertion configuration, the carriage moves horizontally relative to the housing and the shift plate, the injection head, the push plate, and the needle assembly move vertically relative to the housing.

14. The inserter device of claim 12, further comprising a safety assembly having a locking arrangement to prevent movement of the carriage and an unlocking arrangement to allow movement of the carriage.

15. The inserter device of claim 14 , wherein the carriage includes a return spring and the housing includes a return wall that engages the return spring to bias the carriage toward the shift plate.

16. In the locked configuration, the safety assembly extends below the housing; The inserter device of claim 15 , wherein in the unlocked configuration, the safety assembly is pressed into the housing and over the carriage.

17. The inserter device of claim 11 , further comprising a retraction mechanism that automatically moves the needle assembly from the intermediate configuration to a retracted configuration in which the introducer needle is retracted into the housing.

18. The inserter device of claim 17 , wherein the automatic insertion mechanism continues to press the shift plate against the push plate in the retracted configuration.

19. The inserter device of claim 17 , wherein the shift plate is coupled to the housing in the intermediate configuration and remains coupled to the housing in the retracted configuration.

20. 18. The inserter device of claim 17, wherein the needle assembly includes at least one snap arm, and wherein the shift plate holds the at least one snap arm in engagement with the push plate in the insertion configuration and releases the at least one snap arm from the push plate in the intermediate configuration.

21. The inserter device of claim 11 , wherein the push plate is constrained from vertical movement relative to the housing and the shift plate is constrained from vertical movement relative to the push plate.

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