Continuous Analyte Monitor Insertion Device and Method

Abstract

This invention provides an inserter device (e.g., a continuous analyte monitoring inserter device) comprising: an external member; an internal member; a conveyor carrier configured to support a conveyor and a biosensor assembly during biosensor insertion, the conveyor carrier including a biasing member; and a pivoting member configured to pivot relative to the conveyor carrier and support the insertion device during biosensor insertion. The external member is configured to press the biasing member against the pivoting member during biosensor insertion. During a first stroke portion of the insertion device, pivoting of the pivoting member is prevented. In a second stroke portion, pivoting is permitted, and the biasing member causes pivoting of the pivoting member and retraction of the insertion device. Other system and method embodiments are provided.

Description

Technical Field

[0001] This application claims priority to U.S. Provisional Application No. 62 / 889,444, filed August 20, 2019, entitled “CONTINUOUSGLUCOSE MONITOR INSERTER APPARATUS AND METHODS”, and U.S. Patent Application No. 16 / 984,107, filed August 3, 2020, entitled “CONTINUOUS ANALYTE MONITOR INSERTER APPARATUS AND METHODS”, the entire contents of each of which are hereby incorporated herein by reference.

[0002] This disclosure relates to inserters used for continuous analyte monitoring (e.g., in continuous glucose monitoring (CGM)). Background Technology

[0003] CGM in in vivo samples has become a routine sensing procedure, especially in diabetes care. By providing real-time glucose concentrations, timely therapeutic actions (such as insulin administration) can be administered, leading to better control of blood glucose levels.

[0004] During CGM, biosensors are typically inserted subcutaneously and operate continuously in an environment surrounded by tissue and interstitial fluid (ISF). The biosensors, inserted under the skin, provide signals to the transmitter portion of the CGM system, indicating the patient's blood glucose levels. These measurements can be performed intermittently and automatically many times throughout the day (e.g., every few minutes or in some other interval) and are generally transmitted wirelessly to the receiving unit.

[0005] The transmitter portion of a CGM system is typically adhered to the outer surface of the user's skin (e.g., on the abdomen, the back of the upper arm, or another suitable location), while the biosensor is inserted through the skin to contact the ISF. This skin insertion process may be referred to herein as "insertion." The device used to perform the insertion may be referred to herein as an "inserter" or "inserter device."

[0006] Insertor design can be complex and costly to manufacture. Therefore, there is a need for improved insertor methods and devices. Summary of the Invention

[0007] In some embodiments, a continuous analyte monitoring inserter device is provided. The continuous analyte monitoring inserter device includes: an outer member; an inner member configured to be telescopic relative to the outer member; a delivery carrier configured to support a delivery device and a biosensor assembly, the delivery carrier including a biasing member; an insertion device; and a pivoting member configured to pivot relative to the delivery carrier and support the insertion device, wherein axial movement of the outer member is configured to press the biasing member against the pivoting member in a first portion of the travel, and wherein pivoting of the pivoting member is prevented in the first portion of the travel, thereby facilitating movement of the delivery carrier and the insertion device, and in a second portion of the travel, the biasing member is allowed to pivot the pivoting member and retract the insertion device. The biosensor and the insertion device are inserted during the first portion of the travel. The insertion device retracts in the second portion of the travel, leaving the implanted biosensor in place.

[0008] In some embodiments, an inserter for a biosensor configured to insert a transmitter and a biosensor assembly includes: an outer member having a first pivot window and a first alignment feature; an inner member having a second pivot window and a second alignment feature, wherein: the inner member is configured to be telescopically extendable within the outer member; and the first alignment feature of the outer member is configured to intersect with the second alignment feature of the inner member to vertically align the first pivot window with the second pivot window; a transmitter carrier configured to support the transmitter and the biosensor assembly during insertion of the biosensor, the transmitter carrier including a biasing member having an end feature; and a pivoting member configured to pivot relative to the transmitter carrier, the pivoting member including an insertion device support feature and a biasing member intersecting feature, the insertion device support feature being configured to support the insertion device during insertion, and the biasing member intersecting feature being configured to couple with the end feature of the biasing member. The outer member is configured to slide and translate relative to the inner member during insertion and press the biasing member against the pivoting member. Furthermore, during insertion, the pivoting member is prevented from pivoting by the internal components until the insertion device inserts the biosensor of the transmitter and biosensor assembly into the user's subcutaneous region and the first pivot window of the external component overlaps with the second pivot window of the internal component, and the pivoting member enters the first and second pivot windows of the internal and external components that overlap, thereby allowing the biasing member to pivot and the insertion device to retract from the user's subcutaneous region.

[0009] In some embodiments, a method of forming an inserter device includes: providing an outer member; providing an inner member configured to be retractable within the outer member; assembling an assembly of a transmitter carrier, a pivot member, and an inserter device by placing the inserter device into an inserter support feature of a pivot member and into a guide region of a transmitter carrier, the transmitter carrier having a biasing member; bending the biasing member such that an end feature of the biasing member contacts a biasing member junction feature of the pivot member; and inserting the assembly into the outer member and the inner member.

[0010] In another embodiment, a method for inserting a biosensor using an inserter device is provided. The method includes: providing an inserter device including: an outer member; an inner member; a delivery carrier; a biasing member coupled to the delivery carrier; a pivoting member configured to pivot relative to the delivery carrier; and an inserting device including an insert portion; providing a delivery unit and a biosensor assembly detachably coupled to the delivery carrier; an inserting site that contacts the user's skin with the inner member; pushing the outer member such that the biasing member presses against the pivoting member, thereby moving the delivery carrier and the pivoting member toward the inserting site, wherein pivoting of the pivoting member is prevented during a first portion of the travel of the inserter device; continuing to move the delivery carrier and the pivoting member toward the inserting site during the first portion of the travel by further pushing with the biasing member until the inserting portion of the inserting device contacts and enters the inserting site and contacts interstitial fluid, and the bottom surfaces of the delivery unit and the biosensor assembly contact the skin; and performing a second portion of the travel, wherein pivoting of the pivoting member is permitted, and the inserting portion of the inserting device retracts from the inserting site by pulling the pivoting member.

[0011] Other features, aspects, and advantages of embodiments according to this disclosure will be more fully understood in light of the following [Description], claims, and drawings, through the description of several exemplary embodiments and implementations. Various embodiments according to this disclosure may also have other and different applications, and several details of such embodiments may be modified in various ways without departing from the scope of the claims and their equivalents. Therefore, the drawings and descriptions are to be considered illustrative in nature and not restrictive. These drawings are not necessarily drawn to scale. Attached Figure Description

[0012] Figure 1A This is an exploded side perspective view of elements of an example inserter device (e.g., a continuous analyzer monitor (CAM) inserter device) according to one or more embodiments provided herein.

[0013] Figure 1B Based on the embodiments provided herein Figure 1A An exploded side perspective view of an example inserter, relative to... Figure 1A Rotated 180 degrees, and for illustrative purposes, a portion of both the outer and inner components were removed.

[0014] Figure 1C Based on the embodiments provided herein Figure 1A and 1B The inserter is shown in a cross-sectional top view during assembly, with the covers of the external components and the conveyor carrier removed for illustrative purposes.

[0015] Figure 2A This is a side perspective view of an example embodiment of a transmitter carrier according to the embodiments provided herein, wherein the biasing member is shown as unbent.

[0016] Figure 2B This is a side perspective view of an example embodiment of the pivot member according to the embodiments provided herein.

[0017] Figure 2C This is a side perspective view of a transport vehicle assembled with pivoting components and mounting devices according to the embodiments provided herein.

[0018] Figure 2D This is a side perspective view of a biosensor insertion device based on the embodiments provided herein.

[0019] Figure 2E This is an enlarged exploded view of a portion of an insertion device including a biosensor, based on embodiments provided herein.

[0020] Figures 3A-3F The illustration shows side cross-sectional views of the inserter at various points of travel during a method of inserting a biosensor (e.g., a continuous analyte monitor (CAM) biosensor, such as a CGM biosensor) according to embodiments provided herein.

[0021] Figure 4 A flowchart illustrating a method for inserting a biosensor using an inserter according to the embodiments provided herein is shown.

[0022] Figure 5 This is a side perspective view of an alternative embodiment of an inserter that includes an ergonomic gripping portion.

[0023] Figure 6 This is a partial cross-sectional side view illustrating an alternative embodiment of the inserter, illustrating the detachment features that allow for the removal of the transmitter and biosensor assembly according to the embodiments provided herein.

[0024] Figure 7 This is a perspective side view of an alternative embodiment of an inserter with an oval outer cross section, based on the embodiments provided herein.

[0025] Figure 8A Based on the embodiments provided herein Figure 7 A perspective bottom view of the transmitter vehicle for the installation device.

[0026] Figure 8B This is a perspective bottom view of a transmitter vehicle according to the embodiments provided herein, in which a transmitter and a biosensor assembly are installed. Detailed Implementation

[0027] In one or more embodiments described herein, an inserter device (e.g., a continuous analyte (e.g., glucose) monitoring inserter device) is provided, which can be manufactured inexpensively and, in some embodiments, includes one or more biodegradable and / or recyclable components. For example, in some embodiments, the inserter device may include a transmitter carrier and a biasing member, the transmitter carrier holding the transmitter (e.g., the transmitter of the transmitter and biosensor assembly) during insertion of the biosensor assembly, and the biasing member biasing the transmitter carrier toward the user during insertion. In one or more embodiments, the transmitter carrier and biasing member may be formed from a single piece of material, which reduces manufacturing costs and complexity. Once applied to the user's skin, the transmitter and biosensor assembly can transmit signals to a receiving device (e.g., a receiver with a display, or a smartphone (not shown)), in which the analyte measurement (e.g., continuous glucose measurement) can be received (e.g., wirelessly received) and / or displayed.

[0028] In some embodiments, one or more portions of the inserter (e.g., portions used to facilitate movement of the transmitter vehicle toward the user during insertion) may be formed of biodegradable and / or recyclable materials (e.g., recyclable plastics, biodegradable paper products, etc.).

[0029] References are provided below in this article. Figure 1A-8B This describes these and other features of the implant, the manufacture of the implant, and the process of using the implant to insert a biosensor into a user's skin.

[0030] Figure 1A This is an exploded side perspective view of an example CGM inserter 100 according to one or more embodiments provided herein. Although the CGM inserter 100 is shown, it should be understood that the inserter device described herein can be used to insert other types of biosensors used in other types of continuous analyte monitoring systems (e.g., cholesterol, lactate, uric acid, alcohol, or other analyte monitoring systems).

[0031] Refer again Figure 1AThe CGM inserter 100 may include an outer member 102 and an inner member 106. The outer member may include a first pivot window 104, and the inner member has a second pivot window 108. As used herein, the term "window" refers to an opening in the sidewall. The opening may have a rectangular shape in a side plan (e.g., having four sides). However, in some embodiments, one or more of the first pivot window 104 and the second pivot window 108 may have only three sides. For example, one or more of the first pivot window 104 and the second pivot window 108 may be open at their lower ends, with the lower connecting portion or sill removed. Other window shapes (e.g., square, circular, elliptical, etc.) may be used. In some embodiments, the outer member 102 and / or the inner member 106 may be formed of biodegradable and / or recyclable materials (e.g., recyclable plastics, biodegradable paper products, bamboo, etc.). In other embodiments, the outer component 102 and / or the inner component 106 may be formed of one or more materials, such as, but not limited to, acrylonitrile butadiene styrene (ABS), polycarbonate, nylon, acetal, polyphthalamide (PPA), polysulfone, polyethersulfone, polyether ether ketone (PEEK), polypropylene, high-density polyethylene (HDPE), and low-density polyethylene (LDPE). Other materials may be used for the outer component 102 and / or the inner component 106.

[0032] like Figure 1A As shown, the inner member 106 can be configured concentric with the outer member 102 and can be configured to be telescopic within the outer member. As used herein, "telescopic" means that one member can move axially within another member. In some embodiments, the outer member 102 may include a first alignment feature 110, and the inner member 106 may include a second alignment feature 112 that intersects with the first alignment feature 110 of the outer member 102. Such first alignment features 110 and second alignment features 112 can maintain rotational alignment of the outer member 102 and the inner member 106 (e.g., during insertion, to prevent relative rotation of the inner member 106 within the outer member 102) and constrain the outer member 102 and the inner member 106 to telescopic movement. In one or more embodiments, the first alignment feature 110 of the outer member 102 can be configured to intersect with the second alignment feature 112 of the inner member 106 so as to vertically (and rotatably) align the first pivot window 104 of the outer member 102 with the second pivot window 108 of the inner member 106, as... Figure 1A and Figures 3A-3FAs shown in the figure. In some embodiments, the first alignment feature 110 and the second alignment feature 112 may respectively include vertically aligned ridges and grooves. The outer member 102 and the inner member 106 may include a cylindrical, elongated elliptical, oval, elliptical, or any other suitable outer surface shape in cross-section. In some embodiments, the outer member 102 and the inner member 106 may not be concentric.

[0033] CGM implanter 100 may also include a transmitter carrier 114, which is configured to support the CGM implanter and biosensor assembly 310 during implantation of the biosensor 340 of the CGM implanter and biosensor assembly 310. Figures 3A-3F The dimensions of the transport carrier 114 can be adjusted to fit within the internal member 106, and it may include a biasing member 116, which in some embodiments may be integrally formed with the transport carrier. "Dimensioned to fit" means that the transport carrier 114 is configured to be telescopically retractable within the internal member 106, and for example, to be slidably fitted thereto. A slight interference fit may be provided between the transport carrier 114 and the internal member 106, such that the transport carrier 114 will not fall out of the internal member 106 due to gravity, and that relative movement is allowed by overcoming friction.

[0034] The CGM inserter 100 may further include a pivot member 118 configured, for example, to pivot relative to the conveyor carrier 114 and to support and operatively drive the inserting device 120 during the insertion method of the biosensor 340 of the CGM conveyor and biosensor assembly 310, as further described herein. More specifically, the pivot member 118 may be configured to pivot on the conveyor carrier 114.

[0035] In some embodiments, the conveyor carrier 114 and / or pivot member 118 may be formed of a plastic material, such as, but not limited to, acrylonitrile butadiene styrene (ABS), polycarbonate, nylon, acetal, polyphthalamide (PPA), polysulfone, polyethersulfone, polyetheretherketone (PEEK), polypropylene, high-density polyethylene (HDPE), and low-density polyethylene (LDPE). Other suitable materials may be used for the conveyor carrier 114 and / or pivot member 118.

[0036] In some embodiments, the inner member 106 may include a pre-installation locking feature 121 configured to hold the inner member 106 relative to the outer member 102 until a certain applied design force (see reference). Figure 3AThe design force F is exceeded. After the design force F is exceeded, the inner member 106 can be further axially moved and translated (e.g., telescopically) into the outer member 102. For example, the pre-installation locking feature 121 can be configured to extend into the pivot window 104 of the outer member 102, or into another internal feature (e.g., a lateral groove) of the outer member 102, to prevent the outer member 102 from sliding further on the inner member 106 before installation, as referred to herein below. Figures 3A-3F However, after the design force is overcome by the user applying an axial force F on the outer member 102, the pre-installed locking feature 121 can flex and move axially within and along the inner surface of the outer member 102, thereby allowing the inner member 106 to slide (e.g., telescop) relatively into the outer member 102.

[0037] Figure 1B Based on the embodiments provided herein Figure 1A An exploded side perspective view of an example CGM inserter 100, relative to... Figure 1A Rotated 180 degrees, wherein for illustrative purposes a portion of the outer member 102 and the inner member 106 are removed. Figure 1B An internal guide feature 122 is illustrated for internal member 106, along which pivot member 118 can slide axially for at least a portion of the travel during the insertion method, as further described herein. In some embodiments, internal guide feature 122 may be an axially configured and aligned slot or recess, which may have a width slightly larger than pivot member 118.

[0038] Figure 1C Based on the embodiments provided herein Figure 1A and 1B A top cross-sectional view of the CGM inserter 100 during assembly, with the cover 124 of the outer component 102 removed for illustrative purposes. Figure 1A ) and the transport vehicle 114. (e.g.) Figure 1C As shown, the outer member 102 and the inner member 106 can be arranged concentrically. The first alignment feature 110 of the outer member 102 can be aligned with the second alignment feature 112 of the inner member 106, maintaining the rotational and / or vertical alignment of the first pivot window 104 of the outer member 102 relative to the second pivot window 108 of the inner member 106. Figure 1A ). Figure 1CThe position of the pivot member 118, guided within the internal guide feature 122 of the internal member 106, is also illustrated. The internal guide feature 122 may include, for example, a recess. Note that other types and / or numbers of alignment features and / or guide features may be used. For example, the internal member 106 may have a raised alignment feature for alignment with a recess or groove formed in the external member 102. Furthermore, the internal guide feature 122 may be a raised guide feature (e.g., a ridge) received in a recess formed in the pivot member 118 to provide axial guidance for the pivot member 118.

[0039] Figure 2A This is a side perspective view of an example embodiment of the transmitter carrier 114 provided herein, wherein the coupled biasing member 116 is shown as unbent. After manufacturing and before assembly within the CGM inserter 100, the biasing member 116 can be as follows: Figure 2A The ground shown is straight (or unbent).

[0040] Further reference Figure 2A The transmitter carrier 114 can be formed from a cylindrical body region 202, which includes an upper region 204 and a lower region 206. A biasing member 116 is coupled to the upper region, and the lower region is used to support the CGM transmitter during insertion (as further described herein). The upper region 204 also houses a support structure 209, which is configured to support the pivot member 118 (…). Figure 1A The support structure 209 may include a first side 210 having a first guide region 212 and a second side 214 having a second guide region 216. The guide regions 212 and 216 may include axially oriented and extending open slots and can be used to axially guide the insertion device 120 during the insertion method. Figure 1A and 2D (as further described in this article).

[0041] The upper region 204 may have a compression feature 218 that can compensate for compression of the user's soft tissue during the insertion method. For example, during the insertion method, the compression feature 218 (which is a circumferentially extending slot in the depicted embodiment) may allow some movement of the biasing member 116 relative to the lower region 206 of the cylindrical body region 202 when the bottom of the lower region 206 contacts the user's skin and compresses the underlying soft tissue. This can facilitate maintaining skin contact between the CGM transmitter and the biosensor assembly 310 during the insertion method. Alternatively, the compression feature 218 may be located in the lower region 206 or may be provided by another flexible structural configuration.

[0042] For example, in some embodiments, the compression feature 218 may include one or more openings in the cylindrical body region 202. For example, as Figure 2A As shown, a portion of the cylindrical body region 202 can be removed. In some embodiments, the compression feature 218 may extend about halfway around the cylindrical body region 202 and may have a height of about 1 mm to 6 mm. Other types, numbers, locations, and / or sizes of compression features may be used. In some embodiments, compression features may not be used.

[0043] The biasing member 116 may include a contact feature 220, which may be configured to contact the cover 124 of the outer member 102 during the insertion method. Figure 1A The contact feature 220 may be a flat area formed along the length of the biasing member 116 on the underside of the cover 124 of the outer member 102. The contact feature 220 may be a flat surface and may be circular when viewed in a plan view. Other suitable shapes may be used. The contact feature 220 may be attached to the cover 124, or in other embodiments may only contact the cover 124. For example, in some embodiments, the contact feature 220 may be allowed to be formed as described above. Figure 3A Arrow 221 indicates that the cover 124 slides or otherwise moves laterally relative to its underside (e.g., contact feature 220 may form a sliding contact with cover 124). Contact feature 220 may, for example, facilitate substantially more uniform bending of bias member 116 during insertion.

[0044] The biasing member 116 may be formed of a flexible material (e.g., flexible plastic) that allows the biasing member 116 to bend or flex, such as... Figure 1A , 1B As shown in 2C and 3A-3F. Example dimensions of bias member 116 range from approximately 75 mm to 150 mm in length, 3 mm to 8 mm in width, and 1.0 mm to 2.5 mm in thickness. Other dimensions may be used. Example bias member materials include acrylonitrile butadiene styrene (ABS), polycarbonate, nylon, acetal, polyphthalamide (PPA), polysulfone, polyethersulfone, polyetheretherketone (PEEK), polypropylene, high-density polyethylene (HDPE), and low-density polyethylene (LDPE). Other materials may be used.

[0045] like Figure 2AAs shown, in some embodiments, the biasing member 116 may include a locking feature 222 that can engage with the second pivot window 108 of the inner member 106 after insertion to restrict movement of the biasing member 116, the pivot member 118, and / or the insertion device 120 after insertion (as further described herein). The biasing member 116 may also include an end feature 224 for contacting the pivot member 118. In some embodiments, the end feature 224 may include a cylindrical portion adapted to mate with a similar portion of the pivot member 118. However, other suitable end features that allow engagement with features of the pivot member 118 may be used.

[0046] Figure 2B This is a side perspective view of an example embodiment of the pivot member 118 provided herein. The pivot member 118 may include a mounting device support feature 226 (e.g., a slot or other opening) on ​​a first end 118A, the mounting device support feature being configured to support the mounting device 120 during the mounting method. Specifically, the feet 120L of the body 120M of the mounting device 120... Figure 2D The implantation device 120 is supported during the first and second parts of the process, wherein the first part includes the insertion of the insertion portion 120I of the implantation device 120, and the second part includes the retraction of the insertion portion 120I of the implantation device 120, thereby allowing the biosensor 240 to be implanted. Implantation device support feature 226 ( Figure 2B The device may include a first extending slot 227 that extends fully through the lateral width of the pivot member 118 and may have an open end at the first end 118A, thus forming a fork with an upper fork member 226U and a lower fork member 226L. The fork is configured and sized to slidably receive the main body portion 120M of the insertion device 120. A second extending slot 229 may extend vertically through the lower fork member 226L to intersect the first extending slot 227 and may be configured and sized to receive the insertion portion 120I of the insertion device 120 (see reference). Figure 2D For illustrative purposes, the upper and lower parts are used in this text to refer to... Figure 2B The orientation shown is for reference only; however, it should be recognized that the pivot member 118 may be oriented in other ways during its use.

[0047] Furthermore, the pivot member 118 may include a biasing member junction feature 228 configured to junction with an end feature 224 of the biasing member 116. The pivot member 118 may also include one or more pivot features 230 that allow the pivot member 118 to pivot on or relative to the transport carrier 114. For example, the pivot member 118 may include a pivot feature 230 comprising a pivot post (…). Figure 2BOnly one pivot column is shown in the diagram, the pivot column and the pivot opening 232 formed in the first side 210 and the second side 214 of the support structure 209 of the transporter carrier 114. Figure 2C ) handover (refer to) Figure 2C The opening 231 may be a relative slot that allows the pivot member 118 to make some defined axial movement during assembly via a pivot post, such pivot post sliding in the opening 231 and stopping at the pivot opening 232 formed in the respective first side 210 and second side 214. Figure 2C (In this context, other suitable pivoting mechanisms can be used.)

[0048] Figure 2C A side perspective view is shown of a transport vehicle 114 assembled with a pivot member 118 and a mounting device 120 according to an embodiment provided herein. Figure 2C As shown, the biasing member 116 is bent or flexed such that the end feature 224 of the biasing member 116 contacts the biasing member junction feature 228 and is aligned in this biasing member junction feature (see reference). Figure 3A Pivoting feature 230 of pivot member 118 (e.g.) Figure 2B The column can intersect and snap into the pivot opening 232 of the first side 210 of the support structure 209. A similar pivot feature on the opposite side of the pivot member 118 can intersect and snap into a similar pivot opening formed in the second side 214 of the support structure 209 (not shown).

[0049] The main body 120M of the insertion device 120 slides into the insertion device support feature 226 of the pivot member 118 (e.g., into a fork), and also into the guide regions 212 and 216 (e.g., open slots) of the first side 210 and the second side 214 of the support structure 209. The insertion device 120 can be further supported during insertion by the opening 306 formed in the conveyor carrier 114. For example, the insertion portion 120I can slide in the opening 306 during insertion when it is driven by the insertion device support feature 226 of the pivot member 118.

[0050] Now refer to Figures 3A-3F The accompanying drawings illustrate the assembly and operation (insertion method) of the CGM inserter 100 according to the embodiments provided herein, showing side cross-sectional views of the CGM inserter 100 during different portions of the process of inserting a biosensor (e.g., CGM biosensor 240).

[0051] Reference Figure 3ATo assemble the CGM inserter 100, the insert device 120 is placed in the insert device support feature 226 of the pivot member 118, and also in the guide regions 212 and 216 of the first side 210 and the second side 214 of the support structure 209. The biasing member 116 is bent or flexed such that the end feature 224 of the biasing member 116 contacts and aligns with the biasing member junction feature 228 of the pivot member 118. Pivoting feature 230 ( Figure 2B ) and the pivot opening 232 on the first side 210 of the support structure 209 Figure 2C A similar pivoting feature on the opposite side of the pivoting member 118 may intersect with a pivoting opening (not shown) in the second side 214 of the support structure 209. Other suitable configurations that allow the pivoting member 118 to pivot on the transport carrier 114 may be used.

[0052] like Figure 3A As shown, the insertion device 120 has a main body portion 120M and an insertion portion 120I. The main body portion is located within an insertion device support feature 226 (e.g., a fork) of the pivot member 118. The insertion portion extends into and beyond the lower region 206 of the conveyor carrier 114 via a support opening 306 in the base plate region 308 of the conveyor carrier 114 (for use during the insertion method). The insertion portion 120I of the insertion device 120 may have a sharp end 120S. Figure 2D ), its puncture of the user's skin 313 ( Figures 3A-3F The biosensor 240 (e.g., a CGM biosensor) is introduced into the user's subcutaneous region at the insertion site 314, as further described herein. The insertion portion 120I may also be referred to as an insertion shaft, needle, ferrule, sharp instrument, etc. After the insertion portion 120I retracts, the biosensor 340 received in the insertion portion 120I remains in the user's subcutaneous region (i.e., implanted therein).

[0053] In some embodiments, the opening 306 in the base plate region 308 of the transmitter carrier 114 is positioned and / or centered below the guide regions 212 and 216 of the first side 210 and the second side 214 of the support structure 209, such that the insertion portion 120I is supported during insertion to maintain a substantially vertical orientation (as shown) (and / or substantially perpendicular to the area to which the insertion portion 120I is to be inserted), as Figure 3A As shown in the diagram, opening 306 may include a tight fit with the insertion portion 120I to act, for example, as an alignment guide to provide approximately vertical orientation of this insertion portion.

[0054] The insertion portion 120I of the insertion device 120 can be made of, for example, metal (e.g., stainless steel) or non-metal (e.g., plastic). Other suitable materials may be used. In some embodiments, the insertion portion 120I of the insertion device 120 may include a side-open channel 120C extending along the length of the insertion portion 120I. The side-open channel may be, but is not limited to, a circular C-shaped channel tube, a circular U-shaped channel tube, a stamped metal sheet component folded into a square U-shaped profile, a molded / cast metal component with a square U-shaped channel profile, or a solid metal cylinder with an etched or ground square U-shaped channel. Other insertion portion shapes may be used that allow insertion and retraction while leaving the implanted biosensor 340 (e.g., a CGM biosensor). After the insertion portion 120I retracts, the biosensor 240 may slide along the interior of the side-open channel 120C and remain implanted, while the exit portion 240E of the biosensor may slide along the opening of the side-open channel 120C.

[0055] The main body 120M of the mounting device 120 may include a cylindrical or other shaped body and may extend laterally to the corresponding sides 210, 214 of the support structure 209 as shown, and may be formed of a plastic material, for example, but not limited to, acrylonitrile butadiene styrene (ABS), polycarbonate, nylon, acetal, polyphthalamide (PPA), polysulfone, polyethersulfone, polyetheretherketone (PEEK), polypropylene, high-density polyethylene (HDPE), and low-density polyethylene (LDPE). Other materials may be used.

[0056] After assembling the transmitter carrier 114 with the pivot member 118 and the insertion device 120, the transmitter carrier 114 is inserted into the outer member 102 and the inner member 106. For example, the contact feature 220 of the transmitter carrier 114 can be coupled to the cover 124 of the outer member 102 (e.g., by adhesive, suitable snap-fit ​​fastening mechanism, etc.). The cylindrical body region 202 can contact the inner surface of the inner member 106, as can a portion of the biasing member 116, as shown. The biasing member 116 can also contact the outer member 102 as described herein (through contact feature 220).

[0057] Therefore, the method of forming the inserter device 100 involves: providing an outer member 102; providing an inner member 106 configured to be retractable within the outer member 102; and assembling an assembly of the transmitter carrier 114 having the biasing member 116, the pivot member 118, and the inserter device 120 by placing the inserter device 120 into the inserter device support feature 226 of the pivot member 116 and into the guide region of the transmitter carrier 114. Figure 2C); bending the biasing member 116 such that the end feature 224 of the biasing member 116 contacts the biasing member junction feature 228 of the pivot member 116; and assembling ( Figure 2C It is inserted into the external component 102 and the internal component 106.

[0058] like Figures 3A-3F As shown, the inner member 106 is sized to fit within the outer member 102 (i.e., configured to be telescopic within the outer member 102) and may, for example, have a tight sliding fit with the outer member. In some embodiments, the inner member 106 may include a pre-insertion locking feature 121 configured to extend into a first pivot window 104 of the outer member 102 to prevent the outer member 102 from sliding too far on the inner member 106 before insertion.

[0059] After sufficient axial force F is applied to the outer member 102 (e.g., applied by the user), the surface 218S of the pivot member 118 can then move (e.g., vertically as shown), thus sliding relative to the inner member 106 along the guide feature 122 (e.g., the groove). Figure 3A In the position shown, while the pivot member 118 is located within the guide feature 122, the internal member 106 prevents the pivot member 118 from pivoting. Specifically, the pivot member 118 is prevented from pivoting within the first portion of the travel of the CGM inserter 100.

[0060] During operation, the transmitter and biosensor assembly 310 (e.g., the CGM transmitter and biosensor assembly shown in dashed lines) can be detachably coupled to the transmitter carrier 114. In some embodiments, the transmitter and biosensor assembly 310 may be positioned within a recess 330 in the lower region 206 of the transmitter carrier 114. During insertion, the insertion portion 120I extends through the transmitter and biosensor assembly 310. The transmitter and biosensor assembly 310 may include an adhesive layer (not shown) to adhere the transmitter and biosensor assembly 310 to the user's skin 313. However, it should be understood that the recess is optional, and the transmitter and biosensor assembly 310 can be detachably mounted to the lower region 206 of the transmitter carrier 114 simply by any suitable releasable mechanism.

[0061] To begin the insertion method, the inserter device 100 is positioned in contact with the skin 313 at the user's insertion site 314 (e.g., on the upper arm, abdominal region, or another appropriately approved location to avoid insertion into the muscle). This is shown in... Figure 3A middle.

[0062] To initiate insertion, an axial force F is applied to the outer member 102 by the user (or another person) to cause the outer member 102 to slide on the inner member 106 and translate toward the insertion point 314. In some embodiments, the outer member 502 ( Figure 5 The device may include a top profile 503, which includes an uneven top surface portion configured to be gripped by the hand of a user (or another person), wherein the top profile 503 includes a composite curved surface comprising a plurality of consecutive radii extending across the top profile 503.

[0063] The top profile 503 and its curvature can be ergonomically shaped to allow for easier gripping and pushing to apply axial force F and to remove the inserter device 100. The top profile 503 may include at least a convex curvature 503CV, but in some embodiments may also include a concave curvature 503CC. Movement of the outer member 102 (or outer member 502) on the inner member 106 causes the conveyor carrier 114 and the pivot member 118 to move (e.g., translate) toward the insertion point 314, such as... Figure 3B As shown in the diagram. A force sufficient to cause the pre-insertion locking feature 121 to flex inward and outward from the pivot window 104 of the outer member 102 is applied to initiate the first portion of the axial travel of the insertion method. During this phase of the insertion method (the first portion of the travel), the pivot member 118 is prevented from pivoting by contacting the inner member 106 as the conveyor carrier 114 and the pivot member 118 move (translate) along the inner guide feature 122 of the inner member 106 toward the insertion point 314.

[0064] like Figure 3C As shown, the transmitter carrier 114 and pivot member 118 move toward the insertion site 314 until the insertion portion 120I contacts and enters the insertion site 314 and the bottom surface 316 of the transmitter and biosensor assembly 310 contacts the skin 313 at the insertion site 314. In some embodiments, the bottom surface 316 of the transmitter and biosensor assembly 310 may include an adhesive material (e.g., a pressure-sensitive adhesive) that adheres to the user's skin 313 at the insertion site 314 during this stage. CGM biosensor 340 ( Figure 3D It enters the insertion site 314 together with the insertion portion 120I of the insertion device 120 (where it will come into contact with the interstitial fluid).

[0065] like Figure 3C As shown, the pivot member 118 remains in contact with the inner surface of the inner member 106 and is still prevented from pivoting at this stage. This keeps the insertion portion 120I in a fixed position relative to the pivot member 118 and the conveyor carrier 114.

[0066] like Figure 3DAs shown, after the CGM biosensor 340 is inserted (and / or the transmitter and biosensor assembly 310 is attached to the insertion site 314), the outer member 102 continues to move axially and retractably toward the insertion site 314 on the inner member 106. As the end of the pivot member 118 enters the second pivot window 108 of the inner member 106, the pivot member 118 is now free to begin pivoting in the second portion of its travel. Following a further pushing motion, the end of the pivot member 118 can enter the overlapping first pivot window 104 and second pivot window 108 of the outer member 102 and the inner member 106. The first pivot window 104 of the outer member 102 then overlaps with the second pivot window 108 of the inner member 106, such that the pivot member 118, through entering the overlapping first pivot window 104 and second pivot window 108 of the outer member 102 and the inner member 106, is now free to fully pivot. Due to the force applied to the pivot member 118 by the biasing member 116, the pivot member 118 pivots (as shown in the image). Figure 3D (As shown in the diagram). When this occurs, the insertion portion 120I of the insertion device 120 retracts from the insertion point 314 during the second portion of the travel. In at least one embodiment, the height of the second pivot window 108 of the inner member 106 and / or the height of the first pivot window 104 of the outer member 102 can be selected to specify and / or indicate when the pivot member 118 begins to pivot and / or when it is fully pivoted during the insertion method.

[0067] As the outer member 102 continues to move toward the insertion point 314 on the inner member 106, the cover 124 of the outer member 102 continues to push the biasing member 116 against the pivoting member 118. Finally, as Figure 3E As shown, the pivot member 118 pivots sufficiently to allow the insertion device 120 to be fully withdrawn and exit the opening 306, and to exit the guide region 212 of the support structure 209 of the conveyor carrier 114. This prevents accidental reinsertion of the insertion portion 120I of the insertion device 120 into the insertion point 314. Furthermore, after insertion, as the bias member 116 continues to move toward the insertion point 314, the locking feature 222 of the bias member 116 can enter the second pivot window 108 of the inner member 106. This prevents the bias member 116 from retracting (and prevents the pivot member 118 from pivoting in a direction that could cause the insertion device 120 to re-enter the insertion point 314).

[0068] The CGM implant 100 can then be removed, leaving the transmitter and biosensor assembly 310 in place, wherein the bottom surface 316 of the transmitter and biosensor assembly 310 adheres to the user's skin 313 at the implantation site 314 and the biosensor 340 (e.g., CGM or other biosensor type) is implanted in contact with interstitial fluid (e.g., Figure 3F (as shown in the diagram) and coupled to a transmitter. In some embodiments where the outer component 102 and the inner component 106 are formed of recyclable or biodegradable materials, these components can be recycled or composted.

[0069] As described above, and according to one or more embodiments provided herein, the outer member 102 is configured to move axially relative to the inner member 106. This allows the biasing member 116 to press against the pivoting member 118 during insertion of the biosensor 340. According to one aspect, during insertion of the biosensor 340, the pivoting member 118 is prevented from pivoting in the first portion of its axial travel until insertion has occurred after the end of the pivoting member 118 has passed above the second pivoting window 108 of the inner member 106. Following further axial movement between the inner member 106 and the outer member 102, the first pivoting window 104 of the outer member 102 can fully overlap with the second pivoting window 108 of the inner member 106. This overlap in the second portion of the axial travel allows the biasing member 116 to fully pivot the pivoting member 118 and retract the insertion device 120, thereby allowing the biosensor 340 to be implanted.

[0070] For example, during insertion of the biosensor 340, pivoting of the pivot member 118 can be prevented by contacting the end of the pivot member 118 with the inner member 106 (e.g., via the guide surface 122 of the inner member). Furthermore, the biasing member 116 may include a locking feature 222 that engages the second pivot window 108 of the inner member 106 after insertion and restricts movement of both the biasing member 116 and the pivot member 118. In some embodiments, during insertion of the biosensor 340, pivoting of the pivot member 118 is prevented until the insertion device 120 has inserted the biosensor 340 into the user's subcutaneous region. Thereafter, pivoting causes the insertion device 120 to retract, thereby leaving the implanted biosensor 340 in place.

[0071] The biasing member 116 can be bent within the CGM inserter 100 and contacts the inner member 106, the outer member 102, and the pivot member 118 during insertion. In some embodiments, the transmitter carrier 114 and the biasing member 116 can be formed from a single piece of material (e.g., using injection molding or a similar process). Similarly, in other embodiments, the transmitter carrier 114, the biasing member 116, and the pivot member 118 can be formed from a single piece of material (e.g., using injection molding or a similar process). The transmitter carrier 114 may include a housing (e.g., a cylindrical body region 202) having a top region (e.g., upper region 204), a bottom region (e.g., lower region 206), and a recess (e.g., recess 330) or lower surface configured to support the transmitter and biosensor assembly 310 during insertion. If recess 330 is used, this recess can be configured to include a snap-fit ​​feature adapted to hold the transmitter and biosensor assembly 310 in place during insertion, but to release the transmitter and biosensor assembly from the transmitter carrier 114 after insertion and retraction. In some embodiments, the housing (e.g., cylindrical body region 202) may include a decompression feature 218 positioned between a top region 204 and a bottom region 206 of the housing (e.g., cylindrical body region 202).

[0072] Now refer to Figure 4 This describes an embodiment of a method 400 for inserting a biosensor (e.g., CGM biosensor 340 or another biosensor type) using an inserter device (e.g., CGM inserter 100). Method 400, in block 402, includes: providing an inserter device comprising: an outer member (e.g., outer member 102) which may have a first pivot window (e.g., first pivot window 104); an inner member (e.g., inner member 106) which may have a second pivot window (e.g., second pivot window 108); a transport carrier (e.g., transport carrier 114); a biasing member (e.g., biasing member 116); a pivoting member (e.g., pivoting member 118) configured to pivot relative to the transport carrier; and an insertion device (e.g., insertion device 120) including an insertion portion (e.g., insertion portion 120I).

[0073] Method 400 further includes, in block 404, providing a transmitter and biosensor assembly (e.g., CGM transmitter and biosensor assembly 310) detachably coupled to a transmitter carrier 114. "Detachably coupled" means that there is a suitable mechanism configured for coupling the transmitter and biosensor assembly 310 to the transmitter carrier 114, wherein the transmitter and biosensor assembly 310 can be easily detached after insertion of a biosensor (e.g., CGM biosensor 340 or another biosensor). The transmitter and biosensor assembly 310 can be mounted to the transmitter carrier 114 via any suitable mechanism that facilitates detachment of the transmitter and biosensor assembly after insertion and retraction of the insertion device 120, for example, using two or more detachment members released after insertion and retraction. In some embodiments, the adhesive force caused by an adhesive backing that adheres the transmitter and biosensor assembly 310 to the user's skin can help detach the transmitter and biosensor assembly 310 from the insertion device 100. Other suitable dismantling components can be used.

[0074] According to method 400, in block 406, the insertion site (e.g., insertion site 314) of the user's skin (e.g., skin 313) comes into contact with the internal component (e.g., internal component 106). The insertion site (e.g., insertion site 314) is broadly defined on the user's body as the location where the transmitter and biosensor assembly 310 and biosensor 340 are to be placed.

[0075] According to method 400, in block 408, a user or other person pushes an external component (e.g., external component 102) so that a biasing component (e.g., biasing component 116) pushes against a pivoting component (e.g., pivoting component 118), thereby causing the transmitter carrier (e.g., transmitter carrier 114) and the pivoting component (e.g., pivoting component 118) to move (translate) toward the insertion point (e.g., insertion point 314), wherein pivoting is prevented during a first portion of the travel of the inserter 100. During the first portion of the travel, the pivoting component (e.g., pivoting component 118) translates but does not rotate or pivot.

[0076] According to method 400, in block 410, the user or another person continues to push, thus continuing to move the transmitter carrier (e.g., transmitter carrier 114) and pivoting member (e.g., pivoting member 118) toward the insertion site within the first part of the stroke by further pushing with a biasing member (e.g., biasing member 116) until the insertion portion (e.g., insertion portion 120I) of the insertion device (e.g., insertion device 120) contacts and enters the insertion site and thereby contacts the interstitial fluid (located below the skin), and the bottom surface (e.g., bottom surface 316) of the transmitter and biosensor assembly 310 contacts the skin 313.

[0077] According to method 400, in block 412, in the second part of the stroke, the pivot member (e.g., pivot member 118) is allowed to pivot, and by the pivot member (e.g., pivot member 118) pulling the insertion portion (e.g., insertion portion 120I) pivot, the insertion portion (e.g., insertion portion 120I) of the insertion device (e.g., insertion device 120) retracts from the insertion point (e.g., insertion point 314).

[0078] According to some embodiments, the internal component includes a pivot window (e.g., a second pivot window 108), and wherein during the insertion of a biosensor (e.g., biosensor 340), the pivot component (e.g., pivot component 118) is prevented from pivoting until the pivot component enters the pivot window (e.g., the second pivot window 108) of the internal component (e.g., internal component 106).

[0079] In the illustrated embodiment, when the first pivot window (e.g., first pivot window 104) overlaps with the second pivot window (e.g., second pivot window 108) in the second portion of the travel, the pivot member (e.g., pivot member 118) is allowed to fully pivot (rotate) and enter the overlapping first and second pivot windows. Retraction of the insertion portion 120I leaves the biosensor 340 in contact with the user's interstitial fluid. It should be understood that in some embodiments, a pivot window may not be required in the outer member 102, provided that sufficient pivoting is allowed after entering the pivot window of the inner member 106 to complete the retraction of the insertion portion 102I.

[0080] Therefore, the transmitter and biosensor assembly 310 is now positioned at the user to transmit continuous analyte measurements (e.g., continuous glucose measurements) to an external receiver (not shown).

[0081] Figure 6The diagram illustrates an example detachment mechanism implemented in a portion of an inserter device 600 according to embodiments provided herein, wherein the transmitter and biosensor assembly 610 (shown in dashed lines) are detachably coupled to the underside of a transmitter carrier 114. As shown, the inner member 106 may include one or more retainer feet 550 (two or three in some embodiments) that extend partially inward. Normally, one or more outwardly extending partial contact features 552 on the outer surface of the inner member 106 contact the inner surface of the outer member 102, which thus partially bends a portion of the inner member 106 and moves the retainer feet 550 inward to retain and hold the transmitter and biosensor assembly 610. After the outer member 102 is pushed toward the user's skin far enough (as shown), one or more partial release openings 554 align with one or more partial contact features 552, allowing the partial contact features 552 to snap back into one or more partial release openings 554. This causes the retainer foot 550 to move away from the transmitter and biosensor assembly 610 and release the transmitter and biosensor assembly, allowing the transmitter and biosensor assembly to be detached from the inserter device 600.

[0082] Figure 7 An alternative embodiment of the inserter device 700 is illustrated. In this embodiment, according to the embodiments provided herein, the cross-sections of the outer member 702 and the inner member 706 each include an oval outer shape. Similarly, the outer member 702 includes a top profile 703 that includes an uneven surface profile comprising a convex curved surface portion 702CV and possibly some concave curved surface portions 702CC. The inner member 706 may include a lower flange 706F extending at least partially or completely around a lower circumference to aid in stabilizing the inserter device 700.

[0083] Figure 8A and 8B This drawing illustrates a perspective bottom view of the internal component 806 and the transporter carrier 814 according to embodiments provided herein, which can be used in conjunction with... Figure 7The inserter device shown is similar to that in other inserter devices. The transmitter carrier 814 includes a pivot member 118 and an inserting device, which includes an inserting portion 120I that can be configured as previously described herein. The inserting portion 120I is configured to extend through the transmitter and biosensor assembly 810. When the inner member 806 is received in the outer member (not shown), a plurality of retainer feet 850 (similar to retainer feet 550) normally move inward to retain and hold the transmitter and biosensor assembly 810 in the recess 830. When the transmitter carrier 814 is pushed far enough within the internal member 806 to the position shown, the partial contact feature 852 is allowed to snap back into one or more partial release openings (such as partial release opening 554), and thus the retainer shank 850 can move away from the transmitter and biosensor assembly 810 and release the transmitter and biosensor assembly, allowing the transmitter and biosensor assembly to be disengaged from the inserter device 800. As shown, the notch 830 may include one or more alignment pins 855 (several are marked) that engage with holes (not shown) in the top surface of the transmitter and biosensor assembly 810 to align the transmitter and biosensor assembly 810 with the transmitter carrier 814.

[0084] The above description discloses only exemplary embodiments. Those skilled in the art will readily understand variations of the apparatus and methods disclosed above that fall within the scope of this disclosure. For example, the CGM inserter 100 is shown as cylindrical. However, other external and internal component shapes (e.g., oval, elongated elliptical, or other shaped cross-sections) may be used.

Claims

1. A continuous analyte monitoring inserter device, comprising: External component, having a first pivot window; An internal component, having a second pivot window, is configured to be retractable relative to the external component; A transmitter carrier configured to support a transmitter and a biosensor assembly, the transmitter carrier including a biasing member formed of a flexible material that allows the biasing member to bend; Install equipment; and A pivoting member is configured to pivot relative to the conveyor carrier and support the mounting device. The axial movement of the external member is configured to bend and press the biasing member against the pivot member within a first portion of the stroke, wherein pivoting of the pivot member is prevented within the first portion of the stroke, thereby facilitating movement of the conveyor carrier and the mounting device. During the second portion of the stroke, the biasing member is allowed to pivot the pivoting member and retract the mounting device. The biasing member includes a locking feature that engages the second pivot window of the internal member after the biosensor is inserted and restricts movement of both the biasing member and the pivoting member. The pivoting member is configured to pivot when the first pivoting window of the outer member overlaps with the second pivoting window of the inner member.

2. The continuous analyte monitoring inserter device of claim 1, wherein the outer member includes a first alignment feature and the inner member includes a second alignment feature, wherein the first alignment feature is configured to intersect with the second alignment feature to vertically align the first pivot window of the outer member with the second pivot window of the inner member.

3. The continuous analyte monitoring inserter device of claim 1, wherein pivoting is prevented from facilitating the insertion of the biosensor during the first portion of the travel, while the pivoting of the pivoting member is allowed to facilitate the retraction of the inserter during the second portion of the travel.

4. The continuous analyte monitoring inserter device of claim 3, wherein during insertion of the biosensor, the pivoting member is prevented from pivoting until the pivoting member enters the pivoting window of the internal member.

5. The continuous analyte monitoring inserter device of claim 1, wherein the transmitter carrier is configured to support the transmitter and biosensor assembly during insertion of the biosensor of the transmitter and biosensor assembly.

6. The continuous analyte monitoring inserter device of claim 1, wherein the pivot member includes an inserter support feature configured to support the inserter during insertion.

7. The continuous analyte monitoring inserter device of claim 1, wherein the pivot member includes a bias member junction feature configured to junction with the bias member.

8. The continuous analyte monitoring inserter device as claimed in claim 1, wherein the biasing member is bent within the continuous analyte monitoring inserter device.

9. The continuous analyte monitoring inserter device of claim 8, wherein the biasing member contacts the inner member, the outer member, and the pivoting member during insertion.

10. The continuous analyte monitoring inserter device as claimed in claim 1, wherein at least the conveyor carrier and the biasing member are formed from a single piece of material.

11. The continuous analyte monitoring inserter device of claim 1, wherein the transmitter carrier includes a housing having a top region and a bottom region, the bottom region being configured to support the transmitter and biosensor assembly during insertion.

12. The continuous analyte monitoring inserter device of claim 11, wherein the housing includes a decompression feature positioned between the top region and the bottom region of the housing.

13. The continuous analyte monitoring inserter device of claim 1, wherein at least one of the internal component and the external component is formed of a biodegradable or recyclable material.

14. The continuous analyte monitoring inserter device of claim 1, wherein the internal member includes a pre-insertion locking feature configured to extend into a first pivot window of the external member to prevent the external member from sliding on the internal member prior to insertion.

15. The continuous analyte monitoring inserter device of claim 1, wherein the cross-sections of the outer member and the inner member each comprise an oval external shape.

16. The continuous analyte monitoring inserter device of claim 1, wherein the external member includes a top profile, the top profile including an uneven top surface portion configured to be held by a user, wherein the top profile includes a composite curved surface comprising a plurality of consecutive radii across the top profile.

17. The continuous analyte monitoring inserter device of claim 1, wherein the internal component includes one or more retainer feet that extend inwardly to retain and hold the transmitter and biosensor assembly.

18. The continuous analyte monitoring inserter device of claim 17, wherein the external member includes one or more partial release openings, and the internal member includes one or more partial contact features, and the one or more partial contact features are allowed to snap into the one or more partial release openings, thereby allowing the one or more retainer handle feet to move away from the transmitter and biosensor assembly and release the transmitter and biosensor assembly.

19. An inserter device configured to insert a biosensor of a continuous analyte monitoring transmitter and a biosensor assembly, the inserter device comprising: The external component has a first pivot window and a first alignment feature; Internal components, having a second pivot window and a second alignment feature, wherein: The internal component is configured to be retractable within the external component; The first alignment feature of the outer component is configured to intersect with the second alignment feature of the inner component in order to vertically align the first pivot window of the outer component with the second pivot window of the inner component. A transmitter carrier, configured to support the transmitter and biosensor assembly during insertion of the biosensor, the transmitter carrier including a biasing member having end features and formed of a flexible material that allows the biasing member to bend; and A pivoting member, configured to pivot relative to the conveyor carrier, includes a mounting device support feature and a biasing member junction feature, the mounting device support feature being configured to support the mounting device during mounting, and the biasing member junction feature being configured to couple with the end feature of the biasing member; The outer member is configured to slide relative to the inner member during insertion and to bend the biasing member and press against the pivot member; and During insertion, the internal component prevents the pivoting member from pivoting until the insertion device inserts the biosensor into the user's subcutaneous region and the first pivoting window of the external component overlaps with the second pivoting window of the internal component, and the pivoting member enters the overlapping pivoting window of the internal and external components. This allows the biasing component to pivot the pivoting member and retract the insertion device from the user's subcutaneous region. The biasing member includes a locking feature that engages the second pivot window of the internal member after the biosensor is inserted and restricts movement of the biasing member and the pivot member.

20. A method of forming an inserter device, the method comprising: Provide an external component with a first pivot window; An internal component is provided, configured to be retractable within the external component, the internal component having a second pivot window; The assembly of the conveyor carrier, the pivot member, and the installation device is formed by placing the installation device in the installation device support feature of the pivot member and in the guide area of ​​the conveyor carrier. The conveyor carrier has a biasing member formed of a flexible material that allows the biasing member to bend. Bending the biasing member such that the end feature of the biasing member contacts the biasing member junction feature of the pivoting member; and The components are inserted into the external and internal components. The biasing member includes a locking feature that engages the second pivot window of the internal member after the biosensor is inserted and restricts movement of both the biasing member and the pivoting member. The pivoting member is configured to pivot when the first pivoting window of the outer member overlaps with the second pivoting window of the inner member.

Images