Biosensor Insertion Device and Method

Abstract

A biosensor inserter includes a pushing member having a pushing element, a contact member including a latch, a transporter carrier supporting a transporter and sensor assembly, and a pivot member having a latch end, the pivot member supporting the insertion device during insertion of the biosensor. In operation, the pushing member is axially collapsed by a user relative to the contact member, the contact member being provided to contact the user's skin. The pushing element is thus pushed against the pivot member and the transporter carrier is translated during insertion of the biosensor. During a first portion of the stroke of the insertion device, insertion of the biosensor is completed and the pivot member is prevented from pivoting. In a second portion of the stroke, after the latch end has moved beyond the latch, the pivot member is allowed to pivot and the insertion device is retracted. Other system and method embodiments are provided.

Description

Technical Field

[0001] This application claims the benefit of priority of U.S. Provisional Application No. 62 / 889,444, filed on Aug. 20, 2019, entitled "CONTINUOUS GLUCOSE MONITOR INSERTER APPARATUS AND METHODS", U.S. Provisional Application No. 63 / 027,346, filed on May 19, 2020, entitled "BIOSENSOR INSERTER APPARATUS AND METHODS", and U.S. Patent Application No. 16 / 984,125, filed on Aug. 3, 2020, entitled "BIOSENSOR INSERTER APPARATUS AND METHODS", each of which is hereby incorporated by reference in its entirety for all purposes.

[0002] The present disclosure relates to an inserter configured to insert a biosensor, which may be part of a continuous glucose monitor (CGM). Background Art

[0003] Continuous analyte sensing (such as with a continuous glucose monitor (CGM)) has become a routine sensing operation, especially in diabetes care. By providing glucose concentration over time to provide real-time glucose monitoring, treatment actions (such as injecting insulin) can be applied in a timely manner to better control blood glucose conditions.

[0004] During CGM operation, the biosensor of a transmitter and sensor assembly is inserted subcutaneously and continuously operates in an environment surrounded by tissue and interstitial fluid (ISF). The biosensor inserted under the skin provides a signal to the transmitter of the transmitter and sensor assembly, and the signal may indicate the patient's blood glucose level. These measurements can be made intermittently and automatically multiple times throughout the day (e.g., every few minutes or at other appropriate intervals).

[0005] The transmitter of the transmitter and sensor assembly is adhered to the outer surface of the user's skin, such as on the abdomen, on the back of the upper arm, or at another appropriate location, while the biosensor is inserted through the skin to contact the ISF. This skin insertion procedure may be referred to as an "insertion". The device used to perform this insertion may be referred to as an "inserter".

[0006] Inserter designs can be complex and expensive to manufacture. Therefore, there is a need for improved inserter device designs and methods of operating them. Summary of the Invention

[0007] In some embodiments, a biosensor inserter includes: a pushing member including a pushing element, a contact member translatable relative to the pushing member, the contact member including a latch, a transmitter carrier translatable relative to the contact member and configured to support a transmitter and sensor assembly during insertion of a biosensor, a pivot member configured to pivot on the transmitter carrier, the pivot member including a latch end, and an insertion device drivable by the pivot member to insert the biosensor, wherein the pivot member is prevented from pivoting during a first portion of a stroke, and wherein when the latch end of the pivot member moves past the latch, the pivot member is allowed to pivot and retract the insertion device during a second portion of the stroke.

[0008] In a further embodiment, there is provided a biosensor inserter configured to insert a biosensor of a continuously monitored transmitter and sensor assembly. The biosensor inserter includes: a pushing member having a rigid pushing element and a first alignment feature; a contact member having a latch and a second alignment feature, the contact member configured to telescope within the pushing member; a transmitter carrier configured to support the continuously monitored transmitter and sensor assembly during insertion of the biosensor; a pivot member configured to pivot relative to the transmitter carrier, the pivot member including a latch end, and an insertion device supported by the pivot member; and wherein the first alignment feature of the pushing member is configured to interface with the second alignment feature of the contact member to align the latch end with the latch, and wherein the pivot member is configured to slide relative to internal guiding features of the contact member and the pivot member is prevented from pivoting during a first portion of a stroke during insertion of the biosensor, and wherein when the latch end of the pivot member moves beyond the latch, the pivot member is allowed to pivot and retract the insertion device during a second portion of the stroke, leaving the implanted biosensor.

[0009] In a further embodiment, a method of inserting a biosensor using an inserter device is provided. The method includes providing a biosensor inserter comprising: a pushing member including a pushing element, a contact member translatable relative to the pushing member, the contact member including a latch, a transporter carrier translatable relative to the contact member and configured to support a transporter and sensor assembly during insertion of the biosensor, a pivot member configured to pivot relative to the transporter carrier, the pivot member including a latch end, and an insertion device drivable by the pivot member; contacting the contact member to a user's skin; pushing on the pushing member during a first portion of a stroke to cause the pushing element to contact the pivot member, translate the transporter carrier, and insert the insertion device and biosensor through and into the user's skin, wherein the pivot member is prevented from pivoting during the first portion of the stroke; and continuing to push the pushing member until the latch end is unlatched from the latch, wherein the pivot member is allowed to pivot during a second portion of the stroke, and retracting the insertion device while leaving the implanted biosensor behind.

[0010] Other features, aspects, and advantages of embodiments in accordance with the present disclosure will become more apparent from the following detailed description, claims, and drawings by way of example of several exemplary embodiments. Various embodiments in accordance with the present disclosure may also have other and different applications, and many details thereof may be modified in different aspects, all without departing from the scope of the claims of this case and their equivalents. Accordingly, this specification is to be regarded as illustrative in nature and not restrictive. BRIEF DESCRIPTION OF THE DRAWINGS

[0011] The drawings of this case are to be considered illustrative rather than restrictive in nature. The drawings are not necessarily drawn to scale. Like reference numerals are used throughout the drawings to designate like elements.

[0012] Figure 1A is a side perspective view of a biosensor inserter in accordance with one or more embodiments provided herein.

[0013] Figure 1B is a bottom perspective view of a biosensor inserter in accordance with one or more embodiments provided herein, the biosensor inserter including a needle cap.

[0014] Figure 1C is a bottom perspective view of a biosensor inserter in accordance with one or more embodiments provided herein, the needle cap of the biosensor inserter being removed to expose the inserter portion of the insertion device.

[0015] Figure 1DIs a cross-sectional side perspective view of a biosensor inserter according to one or more embodiments provided herein, depicting various different components and their interconnection manners.

[0016] Figure 1E Is a partial cross-sectional side perspective view of a biosensor inserter according to one or more embodiments provided herein, depicting a perspective view of various different components in combination with a contact member and a transmitter carrier.

[0017] Figure 1F Is a partial exploded, partial perspective view of a biosensor inserter according to one or more embodiments provided herein, depicting another view of various different components.

[0018] Figure 1G Is a first side perspective view of a contact member of a biosensor inserter according to one or more embodiments provided herein.

[0019] Figure 1H Is according to one or more embodiments provided herein Figure 1G A second side perspective view of the opposite side of the contact member.

[0020] Figure 1I Is a bottom plan view of a transmitter carrier of a biosensor inserter according to one or more embodiments provided herein.

[0021] Figure 1J Is along section line 1J-1J according to one or more embodiments provided herein Figure 1I A cross-sectional side view of the transmitter carrier.

[0022] Figure 1K Is a side perspective view of a transmitter carrier of a biosensor inserter according to one or more embodiments provided herein.

[0023] Figure 1L Is a side perspective view of an assembly of a contact member and a carrier assembly of a biosensor inserter according to one or more embodiments provided herein.

[0024] Figure 1M Is a side perspective view of a carrier assembly of a biosensor inserter according to one or more embodiments provided herein.

[0025] Figure 1N Is a top plan view of a pivot member of a biosensor inserter according to one or more embodiments provided herein.

[0026] Figure 1O Is along section line 1O-1O according to one or more embodiments provided herein Figure 1N A cross-sectional side view of the pivot member.

[0027] Figure 1P is a perspective view of a pivot member in accordance with one or more embodiments provided herein.

[0028] Figure 1Q is a side plan view of a transmitter insertion assembly in accordance with one or more embodiments provided herein, the transmitter insertion assembly including a transmitter and a sensor assembly having a coupled insertion device.

[0029] Figure 1R is a perspective view of a transmitter insertion assembly in accordance with one or more embodiments provided herein.

[0030] Figure 1S is a first side plan view of an insertion device in accordance with one or more embodiments provided herein.

[0031] Figure 1T is a second side plan view of an insertion device in accordance with one or more embodiments provided herein.

[0032] Figure 1U is a side perspective view of an insertion device in accordance with one or more embodiments provided herein, depicting the wiring of a biosensor.

[0033] Figure 1V is an enlarged partial cross-sectional side view of an insertion device in accordance with one or more embodiments provided herein, depicting the wiring of a biosensor.

[0034] Figures 2A to 2F depicts a plurality of side cross-sectional views of a biosensor inserter during various stages of a method of inserting a biosensor in accordance with an embodiment provided herein.

[0035] Figure 3 depicts a flowchart of a method of inserting a biosensor using a biosensor inserter in accordance with an embodiment provided herein.

[0036] Figure 4A is a top perspective view of an alternative embodiment of a biosensor inserter in accordance with the present disclosure.

[0037] Figure 4B is in accordance with the present disclosure Figure 4A a bottom perspective view of a biosensor inserter, with its transmitter and biosensor assembly removed for illustrative purposes.

[0038] Figure 5A is a bottom perspective view of an alternative embodiment of a push member and a push element in accordance with one or more embodiments of the present disclosure.

[0039] Figure 5BIs a partial plan view of an alternative embodiment of a pusher element according to the present disclosure document, the pusher element including a T-shaped cross-section.

[0040] Figure 5C Is a front perspective view of an alternative embodiment of a contact member according to the present disclosure document, the contact member including a flange and a fin support.

[0041] Figure 6A Is a front perspective view of a part of an alternative embodiment of a transporter carrier according to the present disclosure document, the transporter carrier including fins and an enclosed guide.

[0042] Figure 6B Is a front perspective view of an alternative two-piece transporter carrier according to the present disclosure document.

[0043] Figure 6C And Figure 6D Are respectively front perspective views of an inserter device and an insertion needle according to an embodiment of the present disclosure document.

[0044] Figure 7 Is an exploded front perspective view of an alternative embodiment of a biosensor inserter according to the present disclosure document. Detailed Description

[0045] In one or more embodiments described herein, a biosensor inserter that can be manufactured at low cost is provided. The biosensor inserter is configured to implant (insert) a biosensor into a person's skin. For example, in some embodiments, the biosensor inserter may include a transporter carrier and a pusher element, the transporter carrier maintaining a transporter and sensor assembly during insertion of the biosensor, the pusher element translating the transporter carrier toward the user's skin during a first part of the stroke of the biosensor inserter. In one or more embodiments, the pusher element may be formed from a piece of rigid material, which may be integral with or rigidly coupled to the pusher member. The pusher element may be offset from the central axis of the biosensor inserter.

[0046] In some embodiments, a pivot member that contacts and operates to drive an insertion device of the biosensor inserter is restricted from pivoting as the transporter carrier translates toward the user's skin during a first part (insertion part) of the stroke of the biosensor inserter, but is allowed to pivot once unlatched after the biosensor has been implanted into the user's skin. Once unlatched, the pivot member may pivot during a second part of the stroke of the biosensor inserter, which causes retraction (retraction part) of the insertion device and leaves the biosensor inserted into the user's skin. Thus, the pivot member does not pivot during the first part of the stroke.

[0047] These and other structural and functional features of the inserter embodiments will be described below with reference to Figures 1A to 7 Description.

[0048] Figures 1A to 1C FIG. 6 depicts a perspective view of a biosensor inserter 100 in accordance with one or more embodiments provided herein. The biosensor inserter 100 includes a push member 102, which in the depicted embodiment is shown as including two coupled objects, namely a top member 102T and a bottom member 102B that are coupled together. The biosensor inserter 100 further includes a contact member 106 that is axially translatable (along axial axis 105) relative to the push member 102 in the direction shown by arrow 107. Thus, the contact member 106 can be axially received within the push member 102 and collapsed by the push member 102. The push member 102 is the portion that is contacted and pushed by the user during biosensor insertion. Optionally, the push member 102 can be constructed as a single piece.

[0049] As best shown in Figure 1G and Figure 1H , the contact member 106 includes an upper end 106U and a lower end 106L. The lower end 106L can contact the user's skin 113 ( Figures 2A to 2F ) during insertion and retraction of an insertion device 120 to implant a biosensor 150 (see Figure 2B and Figure 2C ) in the skin. The contact member 106 further includes a latch 109 ( Figure 1D ), which is a latch surface (lower latch surface) that will allow a pivot member 116 ( Figures 1N to 1P ) to rotate ( Figures 1L to 1M ) once passed by the movement of the latch end 117 ( Figures 2D to 2F ) of the pivot member 116, which will be described further below. The pivot member 116 is restricted from rotating until the latch end 117 has passed over the latch 109. The latch 109 ( Figure 1D ) of the contact member 106 can be formed as part of a vertically extending notch 106C ( Figures 1A to 1C ), and the latch 109 can include circumferentially disposed surfaces that are wider than the latch end 117 of the pivot member 116. The vertically extending notch 106C can be open at the lower end 106L.

[0050] As Figures 1A to 1FAs shown, the pushing member 102 can include a top member 102T and a bottom member 102B, where the bottom member 102B is coupled to the top member 102T as shown. The bottom member 102B can have a sleeve shape, and the top member 102T can include an inverted cup that can be received on the sleeve. More specifically, the inverted cup includes a top portion 121( Figure 1D ) and an annular sleeve portion 102S, and the top portion can include a circular flat surface. A pushing element 104( Figures 1D to 1E ) extends downwardly from the pushing member 102 and includes a contact end 104C. The pushing element 104 is a rigid member and extends downwardly (in the arranged orientation) from the bottom side 121U of the top portion 121 and is provided to contact the pivot member 116.

[0051] As Figures 1A to 1C and Figure 1E best shown, the top member 102T and the bottom member 102B can be coupled together by any suitable member, such as by having more than two spring tabs 108, each spring tab including an inwardly projecting corner 108P( Figure 1E ) that sits in a fixed feature 108R (such as a slot or groove formed in the bottom member 102B). The inwardly projecting corner 108P functionally snaps into and locks in the corresponding fixed feature 108R of the bottom member 102B to hold the two together as one piece. Optionally, however, the pushing member 102 can be molded as one piece in some embodiments. Additionally, other members can be used to allow for a snap-fit connection of the top member 102T to the bottom member 102B, or otherwise couple the top member 102T and the bottom member 102B. In some embodiments, as Figure 1F shown, the pushing member 102 can include a ramp 128 near its lower end 102L, and the contact member 106 can include an inwardly projecting corner 142 (such as a snap hook) that is configured to engage the ramp 128 in combination. If multiple inwardly projecting corners 108P are used, there can be a corresponding ramp 128 for each inwardly projecting corner.

[0052] In some embodiments, the push member 102 and / or the contact member 106 may be formed from a biodegradable and / or recyclable material (such as recyclable plastics, biodegradable paper products, bamboo, etc.). In other embodiments, the push member 102 and / or the contact member 106 may be formed from one or more polymeric materials, 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 push member 102 and / or the contact member 106.

[0053] Figure 1B Perspective bottom view depicting an exemplary biosensor inserter 100 in accordance with one or more embodiments provided herein. Refer to Figure 1B , the biosensor inserter 100 may include a transmitter and sensor assembly 115 removably mounted to a transmitter carrier 114 (see also Figure 1C and Figure 1D ), such as in a recess 118 ( Figure 1D ). The transmitter carrier 114 may be axially translated relative to the contact member 106, and the transmitter carrier 114 is configured to support the transmitter and sensor assembly 115 during insertion of the biosensor 150 ( Figure 1U , Figure 1V , and Figures 2A to 2D ). In particular, the transmitter and sensor assembly 115 may include transmitter electronics, a power source, and a sensor assembly including the biosensor 150. Thus, the transmitter and sensor assembly 115 is supported during insertion of the biosensor 150.

[0054] In some embodiments, the transmitter and sensor assembly 115 may include a base that supports the transmitter electronics, a power source (e.g., one or more batteries), and a sensor assembly (e.g., a biosensor such as an analyte sensor for determining the concentration of one or more analytes). Exemplary transmitter electronics may include an analog front end for biasing an analyte sensor and for sensing the current passing through the biosensor 150, such as operational amplifiers, current sensing circuitry, and the like. Other transmitter circuitry may include processing circuitry (such as an analog-to-digital converter for digitizing the current signal), memory for storing the digitized current signal, a controller (such as a microprocessor, microcontroller, or the like) for possibly calculating an analyte concentration value based on the measured current signal, and transmitter circuitry for transmitting the analyte concentration value to an external device (such as a smart phone or other suitable external device for storing and / or displaying the analyte concentration). In some embodiments, the transmitter electronics may form a separate transmitter unit that may be reused and that is coupled to a sensor unit of a base unit that has a power source and a sensor assembly. The base unit may be disposable. In such embodiments, the transmitter electronics may be attached to the base unit before or after inserting the biosensor 150 using the biosensor inserter 100.

[0055] In some embodiments, the sensor (e.g., the biosensor 150) used within the transmitter and sensor assembly 115 may include two electrodes across which a bias voltage may be applied. In such cases, a current may be measured through the sensor. In other embodiments, the sensor may include three electrodes, such as a working electrode, a counter electrode, and a reference electrode. In such cases, a bias voltage may be applied between the working electrode and the reference electrode, and a current may be measured through the working electrode, for example. The sensor may include an active region that includes one or more chemical substances that undergo an analyte-enzyme reaction with the product they detect. The enzyme is immobilized on one or more electrodes to provide a reaction with the analyte (e.g., a redox reaction) and generate a current at the electrodes. For example, the reaction may affect the concentration of charge carriers and the time-dependent impedance of the sensor. Exemplary chemical substances include glucose oxidase, glucose dehydrogenase, or the like. In some embodiments, a mediator, such as ferricyanide or ferrocene, may be applied at the active region. In one or more embodiments, the sensor may include a microprobe or a plurality of microprobes (such as a microprobe array). Generally, analytes that may be detected and / or monitored by a suitable sensor include glucose, cholesterol, lactate, uric acid, alcohol, or the like. An analyte is herein defined as a component, substance, chemical species, or chemical constituent that may be measured in an analytical procedure.

[0056] An exemplary biosensor 150( Figure 1U) can be any suitable implantable sensor that can be implanted in the user's skin 113( Figure 2A ) and, like a stranded wire-shaped sensor, can be received inside the insertion portion 120I of the insertion device 120 and can sense the analyte concentration reading of the interstitial fluid under the skin 113, such as a glucose sensor, a lactate sensor, or the like.

[0057] Such as Figure 1Q and Figure 1R shown in, in some embodiments, a transmitter insertion assembly 119 is provided, which is an assembly of the insertion device 120 (shown in Figure 1S until Figure 1V ) and the transmitter and sensor assembly 115. The transmitter insertion assembly 119 can include a needle cap 124 that the user can remove before performing the insertion method. The needle cap 124 can be detached from the insertion device 120 and protects the insertion portion 120I (e.g., the probe portion) of the insertion device 120. Thus, the needle cap 124 can be detached from the threads or other fastening features 120T formed on the body 120B of the insertion device 120. Other configurations of the needle cap 124 can be used.

[0058] As described, the biosensor inserter 100 further includes a pivot member 116 that is configured to pivot on and relative to the transmitter carrier 114. The pivot member 116 (as best illustrated in Figures 1N to 1P ) includes a latching end 117 at a first end and may include an insertion device support feature 139 at an end opposite the first end. The insertion device support feature 139 is configured to contact, support, and drive (insert and retract) the insertion device 120 during the insertion method.

[0059] In some embodiments, the insertion device support feature 139 includes a fork 139F that is configured to receive a leg 120L of the body 120B of the insertion device 120 therein (see Figures 1Q to 1U ). The fork 139F can include a first extended slot that extends completely through the lateral width of the pivot member 116 and can have an open end at an end opposite the latching end 117 of the pivot member 116, thus forming the fork 139F. The upper fork tooth 139FU and the lower fork tooth 139FL of the fork 139F can be configured to receive the leg 120L of the body 120B between the upper fork tooth 139FU and the lower fork tooth 139FL. The leg 120L extends laterally from a rod 120S of the body 120B( Figures 1S to 1U ), and the rod 120S can be received in a vertical gap 139C( Figures 1N to 1P) and through this vertical gap. A second extension slot can extend vertically through at least the lower fork member 139FL to intersect with the laterally extending slot and form a vertical gap 139C. These slots can be resized to receive the legs 120L and the rod 120S of the body portion 120B of the insertion device 120. As used herein, the terms upper and lower refer to Figure 2B the orientation shown in, but it should be understood that the pivot member 116 and other elements can be arranged in other orientations during use.

[0060] The pivot member 116 can also include one or more pivot features that allow the pivot member 116 to pivot relative to the transporter carrier 114. For example, the pivot member 116 can include a laterally extending feature 125 (such as a post), and this laterally extending feature interfaces with holes 127 (see Figure 1K ) in the first and second side supports 135 and 136 of the transporter carrier 114 to form a pivot axis 125A. Thus, the pivot member 116 can pivot about the pivot axis 125A and pivot on the transporter carrier 114.

[0061] The pivot position of the pivot member 116 can be formed between the first end and the opposite end of the pivot member 116. For example, the pivot axis 125A ( Figure 1N ) can be formed by laterally extending features 125 (such as cylindrical post extensions) that project from the respective lateral sides of the body of the pivot member 116. The laterally extending features 125 can be received in holes 127 ( Figures 1J to 1M ) in the first and second side supports 135, 136 of the transporter carrier 114. The pivot member 116 can include a push element interface feature 140, which can include a pocket or other interface feature formed between the pivot axis 125A and the latch end 117, and this interface feature is configured to interface with and contact the contact end 104C ( Figure 1D ) of the push element 104. Other suitable laterally extending features can be used to form the pivot. Other pivot mechanisms can be used, such as removable axles, or the like.

[0062] In some embodiments, the transporter carrier 114 and / or the pivot member 116 can be formed from plastic materials 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 materials can be used for the transporter carrier 114 and / or the pivot member 116.

[0063] In operation, the insertion device 120 can be driven by being contacted by the pivot member 116 during the insertion stroke to as Figure 2B andFigure 2C The insertion of the biosensor 150 into the user's skin 113 as shown. The insertion device 120 can be driven by the legs 120L of the body 120B received in the fork 139F of the pivot member 116. Further, the legs 120L can each include a rectangular portion at their respective outer ends, and these rectangular portions are received in the guides 135G, 136G ( Figure 1M ) of the transmitter carrier 114. The guides 135G, 136G can be vertically arranged slots and can be open at the top. The mating of these rectangular portions with the guides 135G, 136G can be a sliding fit, which can assist in restricting the rotation of the insertion device 120 during insertion. Thus, the guides 135G, 136G and the rectangular ends on the legs 120L can interface to provide an anti-rotation support along an axis that laterally passes through the legs 120L. The transmitter carrier 114 can further include a convex alignment member 138V ( Figure 1I , Figure 1K , and Figure 1M ), such as a vertically extending rib (such as the illustrated rounded rib), and the convex alignment member is configured to interface with a concave alignment member 138C of the contact member 106, such as Figure 1L the recess shown.

[0064] As best illustrated in Figure 1D and Figure 1E , the contact member 106 can be configured to be concentric with the push member 102 and can be collapsible with the push member 102. In some embodiments, the push member 102 can include a first alignment feature 122 (see Figure 1E and Figure 2A ), such as a vertically extending groove or recess, and the contact member 106 can include a second alignment feature 123 ( Figure 2A ) that interfaces with the first alignment feature 122, such as a vertically extending rib. Such alignment features 122, 123 can keep the push member 102 and the contact member 106 rotationally aligned to prevent the contact member 106 from rotating within the push member 102, such as during the insertion and retraction portions of the stroke. The push member 102 and the contact member 106 can be cylindrical, oval, oblong, elliptical, or any other suitable shape in a transverse cross-section. In some embodiments, the push member 102 and the contact member 106 can not be concentric.

[0065] More specifically, Figures 1I to 1M the transmitter carrier 114 shown is configured to support the transmitter and sensor assembly 115 during the insertion of the biosensor 150 of the transmitter and sensor assembly 115. The transmitter carrier 114 can be resized as Figure 1Lis adapted to be within the contact member 106 as shown in the figure, which shows an assembly 141 of the contact member 106, the transmitter carrier 114, the pivot member 116, and the insertion device 120.

[0066] As best illustrated in Figures 1A to 1E In some embodiments, as shown in, the contact member 106 may include a first pre-insertion locking feature 142 that is configured to fix the contact member 106 relative to the pusher member 102 until a specific pre-designed axial force is exceeded. After exceeding the pre-designed force, the contact member 106 may further axially move into the pusher member 102. For example, the first pre-insertion locking feature 142 can be configured to extend into a second pre-insertion locking feature 144 (such as a window or groove formed in the pusher member 102 as shown) to prevent the pusher member 102 from sliding over the contact member 106 before insertion, as will be described with reference to Figures 2A to 2F However, after the user applies an axial force F to the pusher member 102 to overcome the pre-designed force, the first pre-insertion locking feature 142 can bend and axially move inwardly along the inner surface of the pusher member 102, allowing a relative axial sliding movement of the contact member 106 into the pusher member 102. The first pre-insertion locking feature 142 can be a spring tab including a hook or the like located in a groove or slot, as Figure 1E shown in. Once the pre-designed force is overcome, the axial force F may vary slightly for the remainder of the stroke.

[0067] Figure 1F is an exploded (partial cross-section) side perspective view of an exemplary biosensor inserter 100 according to an embodiment provided herein, with a portion of the pusher member 102 and the contact member 106 removed for illustrative purposes. Figure 1F and Figure 1G depict an internal guiding feature 132 formed on an inner surface of the contact member 106, along which one end (e.g., the flat end 116E– Figure 1O ) of the pivot member 116 can slide axially during at least a portion of the insertion method, as further described herein. The internal guiding feature 132 can be a flat-bottomed groove that is slightly wider than the width of the pivot member 116. The internal guiding feature 132 can be associated with the latch 109 ( Figure 1G) intersect at the lower end of the guide feature. The internal guide feature 132 can be axially arranged to receive the end 116E of the pivot member 116 and limit the rotation of the pivot member 116 during a first portion of its travel, during which the end 116E does not rotate but rather slides vertically along the internal guide feature 132 and is restricted from rotating. Note that other types of internal guide features 132 can be used. For example, the contact member 106 can have a protruding alignment feature (such as a rib) that is received in a groove formed in the end of the pivot member 116 to guide the pivot member 116.

[0068] Further reading Figure 1D , the transmitter carrier 114 can be formed from a cylindrical body including a base 134 that is used to support the transmitter and sensor assembly 115 during insertion (as further described herein). The base 134 is also coupled to a support structure that is configured to support the pivot member 116. As best shown in Figures 1J to 1K In the embodiment, the support structure may include a first side support 135 having a first guide 135G and a second side support 136 having a second guide 136G. The guides 135G and 136G may include slots that are axially aligned and extendable and may be employed to guide the insertion device 120 ( Figures 1S to 1U The insertion device 120 slides into the insertion device support feature 139 of the pivot member 116 (e.g., into the fork 139F) and also into the guides 135G and 136G of the first and second side supports 135 and 136, which straddle the pivot member 116.

[0069] like Figure 1D As best shown in FIG, the biasing element 104 can extend downwardly from the bottom side 121U of the top portion 121 and can include a contact end 104C. The biasing element 104 can be substantially rigid and can extend generally perpendicularly from the bottom side 121U and can be offset from the axial axis 105 as shown. The biasing element 104 can include a contact end 104C that contacts and pushes on the pivot member 116 during the insertion method. In some embodiments, the contact end 104C can include contact with the biasing element interface feature 140 (e.g., Figure 1L During insertion, the push element 104 does not bend or deform in any substantial manner, and thus, during the insertion portion of the stroke, pushes on the push member 102 to collapse the contact member 106 within the push member 102 and linearly translate both the pivot member 116 and the transmitter carrier 114 toward the user's skin 113.

[0070] Exemplary dimensions of the pusher element 104 are in the range of approximately 25 mm to 35 mm in length, 5 mm to 15 mm in width, and 3 mm to 10 mm in thickness. Other dimensions may be used. Exemplary materials for the pusher element 104 and the pivot member 116 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.

[0071] Reference will now be made to Figures 2A to 2F illustrate the combination and operation (insertion method) of the biosensor inserter 100, the figures depicting side cross-sectional views of the biosensor inserter 100 during the method of inserting a biosensor 150 in accordance with embodiments provided herein.

[0072] To assemble the biosensor inserter 100, a transmitter insertion assembly 119, which consists of a transmitter and sensor assembly 115 ( Figures 1Q to 1R ) and an insertion device 120 ( Figures 1S to 1V ), is inserted from the bottom such that the body 120B of the insertion device 120 passes through the hole 145 ( Figure 1J ) along the path indicated by the dashed arrow 147 in Figure 1I ), up through the slot end 146, and into the guides 135G, 136G in the transmitter carrier 114. Thus, the ends of the legs 120L are received in the slot end 146 and the ends turn upward and to the right in Figure 1J and into the guides 135G, 136G. Once the transmitter and sensor assembly 115 and the transmitter insertion assembly 119 of the insertion device 120 are properly positioned in the guides 135G, 136G, they can be maintained in position in the transmitter carrier 114 by any suitable quick-release feature, such as a slight interference fit within the recess 118 (see Figure 1D ), or perhaps a small amount of double-sided tape or a suitable low-strength adhesive.

[0073] Next, the fork 139F ( Figure 1M ) of the insertion device support feature 139 of the pivot member 116 is received over the legs 120L and the laterally extending feature 125 of the pivot member 116 is pressed into the holes 127 in the first and second side supports 135, 136 to form a pivot aligned with the pivot axis 125A.

[0074] Next, a carrier assembly 137 ( Figure 1M ), which consists of the transmitter carrier 114 and the pivot member 116, the insertion device 120, and the transmitter and sensor assembly 115 as Figure 1L106 to form a subassembly 141. The carrier assembly 137 can be inserted into the bottom of the contact member 106 until the first stop feature 148 ( Figures 1I to 1J ) contacts one or more second stop features 151 (see FIG. Figure 1G and Figure 1H Other suitable stop features may be utilized to limit the extent to which the carrier assembly 137 can be inserted into the contact member 106. A slight interference fit may be provided between the outer surface of the carrier assembly 137 and the inner surface of the contact member 106 to maintain the assembly 137 inside the contact member 106.

[0075] Then, you can Figure 1D As shown in FIG, the pushing member 102 is partially or completely mounted on the subassembly 141 ( Figure 1L ). The push member 102 can be installed by first installing the bottom member 102B onto the subassembly 141 until the first pre-insertion locking feature 142 snaps into the second pre-insertion locking feature 144. The first pre-insertion locking feature 142 can be a snap-fit hook and the second pre-insertion locking feature 144 can be a slot or groove, for example.

[0076] Next, the top portion 102T can be installed onto the bottom member 102B. Once properly aligned, the two or more spring tabs 108, each including an inwardly facing cam 108P, can be seated within respective securing features 108R. After installation, the biasing member 104 is aligned with and in close proximity to (or just touching) the biasing member interface feature 140 of the pivot member 116. As shown, the contact member 106 is resized to fit within the biasing member 102 and can have a close sliding fit or even a slight interference fit (for example).

[0077] See now Figure 1D 、 Figure 1I 、 Figure 1J ,and Figure 1U The insertion device 120 has a main body portion 120B and an insertion portion 120I. The main body portion 120B is located within the insertion device support feature 139 (e.g., fork 139F) of the pivot member 116. The insertion portion 120I can be inserted from the conveyor carrier 114 through a hole 145 ( Figure 1I ) extends. The insertion portion 120I of the insertion device 120 can have a sharpened tip ( Figure 1U ), which pierces the user's skin 113 ( Figures 2A to 2F)to introduce a biosensor 150 into a subcutaneous region 113S of a user, as further described herein. The insertion portion 120I may also be referred to as an insertion rod, needle, trocar, sharp object, or the like. When the insertion portion 120I is retracted, the biosensor 150 received in an opening 150O (slot, elongate cavity, or groove as shown, e.g., Figure 1U and Figure 1V therein) in the subcutaneous region 113S of the user is maintained.

[0078] In some embodiments, the hole 145 in the base 134 of the transmitter carrier 114 is positioned and / or centered below the guides 135G, 136G of the first and second side supports 135 and 136 such that during insertion the insertion portion 120I is maintained substantially perpendicular (and / or substantially perpendicular to the region into which the insertion portion 120I is to be inserted), as Figure 2A shown therein. The body portion 120B of the insertion device 120 may include a flange 120F ( Figures 1S to 1V ), which may interface with the top surface of the transmitter and sensor assembly 115 as an alignment guide to assist in providing a substantially perpendicular orientation of the insertion portion 120I to the transmitter.

[0079] The insertion portion 120I of the insertion device 120 may be made (e.g.) from metal (such as stainless steel) or non-metal (such as plastic). Other suitable materials may be used. In some embodiments, the insertion portion 120I of the insertion device 120 may be (but is not limited to) a round C-shaped channel tube, a round U-shaped channel tube, a stamped sheet metal part folded to have a U-shaped profile in cross-section, a molded / cast metal part having a U-shaped channel profile in cross-section, or a solid metal cylinder having a channel etched or milled therein resulting in a U-shaped cross-section. Other insertion portion shapes that allow insertion and retraction while leaving the implanted biosensor 150 may be used.

[0080] The body portion 120B of the insertion device 120 may be formed from plastic (by way of example), 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 materials may be used.

[0081] As best shown in Figure 1U and Figure 1VAs shown, the biosensor 150 is received within the opening 150O of the insertion portion 120I, which extends along the length of the insertion portion 120I, turns into a channel 152 formed within the threaded portion 120T, and then exits the channel 152 laterally to connect to a connector, electronic panel, or other similar electronic component 154, which includes or is coupled or configured to couple to a transmitter electronics of the transmitter and sensor assembly 115. Thus, when the insertion portion 120I is inserted into the user's skin 113 and when the insertion portion 120I is retracted from the user's skin 113, the biosensor 150 can maintain its position by moving out of the channel 152 and the opening 150O.

[0082] Reference will now be made to Figures 2A to 2F and Figure 3 to illustrate the operation of the biosensor inserter 100, Figure 3 which depicts a flowchart of a method 300 for inserting a biosensor 150 using the biosensor inserter 100 in accordance with an embodiment provided herein.

[0083] Operationally, in some embodiments, the transmitter and sensor assembly 115 (shown in dashed lines in Figures 2A to 2F ) can be removably coupled to the transmitter carrier 114 and positioned within a recess 118 in a lower region of the transmitter carrier 114. The transmitter and sensor assembly 115 includes an adhesive layer to adhere the transmitter and sensor assembly 115 to the user's skin 113 when the insertion device 120 is retracted. However, as should be apparent, the recess is optional and the transmitter and sensor assembly 115 can be removably mounted to the lower region of the transmitter carrier by any suitable means.

[0084] To begin Figure 3 the insertion method 300, the needle cap 124 is removed from the insertion portion 120I of the insertion device 120 and the contact member 106 of the biosensor inserter 100 is placed in contact with the skin 113 surrounding the user's insertion site 110, which can be on the upper arm, abdominal region, or another suitable location to avoid inserting into muscle. This is shown in Figure 2A .

[0085] To begin the insertion, a force F is applied by the user to the push member 102 to cause the push member 102 to slide above the contact member 106 and move towards the insertion site 110. The movement of the push member 102 above the contact member 106 causes the push element 104 to contact the push element interface feature 140 of the pivot member 116 [see also Figures 1N to 1P , which causes the transmitter carrier 114 and the pivot member 116 to translate and move towards the insertion site 110 (as shown in Figure 2Bas shown in FIG. , the latch end 117 moves linearly relative to the latch 109 of the contact member 106 and toward the latch 109 of the contact member 106 while the end 116E slides along the internal guiding feature 132.

[0086] According to the insertion method 300, after the applied force F is sufficient to bend the first pre-insertion locking feature 142 (such as the hook shown in FIG. ) inward and away from the pre-insertion locking feature 144 (such as a slot or groove) of the pusher member 102, such axial movement is allowed. During this first part of the stroke of the insertion method 300, as the transporter carrier 114 and the pivot member 116 translate toward the insertion site 110, the pivot member 116 is prevented from pivoting by the contact of the end 116E with the wall surface (such as the internal guiding groove) of the contact member 106. Figure 1A As shown in FIG. , the transporter carrier 114 and the pivot member 116 continue to move toward the insertion site 110 until the insertion portion 120I contacts and enters the insertion site 110, and the bottom surface of the transporter and sensor assembly 115 contacts the skin 113 around the insertion site 110. In some embodiments, the bottom surface of the transporter and sensor assembly 115 may adhere (e.g., via an adhesive material) to the skin 113 of the user around the insertion site 110. The insertion portion 120I and the biosensor 150 enter the insertion site 110 where the biosensor 150 can contact the interstitial fluid in the subcutaneous region 113S. The biosensor 150 can be placed, for example, 4 mm to 6 mm into the skin 113, although other depths may be used.

[0087] As Figure 2C shown in FIG. , during the first part of the stroke, the end 116E of the pivot member 116 maintains contact with the inner surface (such as the internal guiding surface of the latch 109) of the contact member 106 and is prevented from pivoting. Thus, during the insertion of the biosensor 150, the pivot member 116 is prevented from pivoting. This causes the insertion portion 120I to remain in a fixed position relative to the pivot member 116 and the transporter carrier 114, with the flange 120F against the top surface of the transporter and sensor assembly 115.

[0088] As Figure 2C shown in FIG.

[0089] As Figure 2DAs shown, after inserting the biosensor 150 (and / or adhering the transmitter and sensor assembly 115 to the skin 113 around the insertion site 110), during the second part of the stroke, the push member 102 continues to move toward the insertion site 110 over the contact member 106. When the latch end 117 of the pivot member 116 moves past the latch 109 at the start of the second part of the stroke, the pivot member 116 is allowed to pivot by the push of the push element 104, rotate under the latch 109 and into the cutout portion 106C. This pivoting causes the insertion device 120 to retract during the second part of the stroke.

[0090] During retraction, due to the force exerted by the push element 104 on the pivot member 116, the pivot member 116 pivots on the transmitter carrier 114 (as Figure 2D shown). At this time, the insertion portion 120I of the insertion device 120 retracts from the insertion site 110 and the flange 120F moves away from the transmitter and sensor assembly 115. As the push member 102 continues to move toward the insertion site 110 over the contact member 106, the push element 104 continues to press against the pivot member 116. Eventually, as Figure 2F shown, the pivot member 116 pivots to a position sufficient for the insertion device 120 to completely move away from the user's skin 113 and leave the implanted biosensor 150 in the user's skin. As the push member 102 is further pushed in, the insertion device 120 fully retracts above the aperture 145. Thus, the insertion portion 120I of the insertion device 120 cannot be inadvertently reinserted into the insertion site 110. Additionally, as the push member 102 continues to move toward the insertion site 110, after insertion, an axial stop feature 155 ( Figure 1J and Figure 2F ) of the transmitter carrier 114 can contact the pivot member 116 and prevent further retraction of the insertion device 120.

[0091] The biosensor inserter 100 can then be removed, leaving the transmitter and sensor assembly 115 in place, the bottom surface of the transmitter and sensor assembly 115 adhered to the user's skin 113 at the insertion site 110 and the biosensor 150 in contact with interstitial fluid (as Figure 2F shown). In some embodiments where the push member 102 and / or the contact member 106 are formed of recyclable or biodegradable materials, these components can be recycled or composted.

[0092] Now refer to Figure 3, an embodiment of method 300 for inserting a biosensor (biosensor 150) using a biosensor inserter (such as biosensor inserter 100) is described. Method 300 includes (at block 302) providing a biosensor inserter 100 that includes: a pushing member (such as pushing member 102) that includes a pushing element (such as pushing element 104), a contact member (such as contact member 106) that is translatable relative to the pushing member, the contact member including a latch (such as latch 109), a transmitter carrier (such as transmitter carrier 114) that is translatable relative to the contact member and is configured to support a transmitter and sensor assembly (such as transmitter and sensor assembly 115) during insertion of the biosensor (such as biosensor 150), a pivot member (such as pivot member 116) that is configured to pivot relative to the transmitter carrier, the pivot member including a latch end (such as latch end 117), and an insertion device 120 (insertion device 120) that is drivable by the pivot member.

[0093] Method 300 further includes (at block 304) contacting the contact member (such as contact member 106) to the skin of a user (such as Figure 2A skin 113 shown therein). This contacting step is followed (at block 306) by pushing on the pushing member 102 (such as pushing member 102) to cause the pushing element 104 to contact the pivot member 116 (such as at the pushing element interface feature 140, like a pocket), translating the transmitter carrier (such as axially translating transmitter carrier 114 within contact member 106), and inserting the insertion device (such as insertion portion 120I of insertion device 120) and biosensor 150 through the skin 113 of the user, wherein the pivot member (such as pivot member 116) is prevented from pivoting. In particular, the pivot member (such as pivot member 116) is prevented from pivoting over a first portion of the stroke.

[0094] Method 300 further includes (at block 308) continuing to push the pushing member (such as pushing member 102) until unlatching of the latch end (such as latch end 117) from the latch (such as latch 109 of contact member 106) occurs, wherein the pivot member 116 is allowed to pivot and retract the insertion device 120 while leaving the biosensor 150 implanted in the skin 113 of the user. Unlatching occurs after the first portion of the stroke when the latch end 117 moves beyond the latch 109 (as a result of the pushing element 104 pushing on the pivot member 116) and is able to rotate under the latch 109. Pivoting of the pivot member 116 during the second portion of the stroke of the pushing member 102 operatively retracts the insertion portion 120I of the insertion device 120 from the skin 113 of the user and leaves the implanted biosensor 150 thereafter.

[0095] Figure 4A and Figure 4B An alternative embodiment of the illustrated biosensor inserter 400 is shown. This embodiment has several features that are ergonomically and / or functionally advantageous compared to the embodiments previously described herein. In particular, the overall shape, including the shape of the push member 402 and the contact member 406, is elongated in a transverse cross-section compared to the circular shape of the biosensor inserter 100 embodiment shown in Figures 1A to 1C . This elongated shape allows for a more ergonomic grip on the push member 402. Additionally, since the transmitter and sensor assembly 115 (not shown in Figure 4B ) tends to be composed of rectangular circuit system components, the elongated shape can provide a more compact overall configuration. To further improve the ergonomic grip of the push member 404, the insertion device 400 can include a plurality of ridges 454 that extend circumferentially around the upper perimeter of the push member 402. As shown, the ridges 454 can extend around the top portion of the push member 402 for more than 150 degrees. Similar ridges 454 are provided on opposite sides of the push member 402. As shown, three ridges are formed by molding on each side and extend circumferentially around the perimeter of the push member 402 and connect to the end ridges 455A, 455B. The end ridges 455A, 455B can be aligned in the vertical direction as shown. The height of the ridges 454 can vary to provide an arcuate vertical grip profile, as best shown at the end ridges 455A, 455B. The height range of the ridges 454 can be from 1 mm to 3 mm for each ridge 454, for example. The width range of the ridges 454 can be from 1 mm to 5 mm for each ridge 454, for example.

[0096] Referring now to Figures 4A to 4B and Figure 5C , another embodiment of the contact member 406 is provided, which can include a peripheral flange 458. The peripheral flange 458 can extend outwardly from a portion or all of a body portion 406B of the contact member 406. As best shown in Figure 4B , the peripheral flange 458 can extend outwardly a width W, which is measured along the plane of the flange 458 from an inner edge 458i to an outer edge 458o. The width W can be greater than or equal to 5 mm for at least midway around the perimeter, where W is the width of the peripheral flange 458. In some embodiments, the peripheral flange 458 can extend completely around the perimeter and can have a width W greater than or equal to 5 mm at all locations. The inner edge 458i can include some recesses and protrusions for engaging with the transmitter carrier 414. In some embodiments, the contact member 406 having the peripheral flange 458 can have Ac≥500 mm 2, where Ac is the contact area of the surrounding flange 458, and this contact area is configured to contact the user's skin during the insertion of the biosensor.

[0097] Referring now Figure 5A and Figure 5B , the pushing element 504 extending from the bottom side 521U of the pushing member 402 can include a T-shaped cross-section along at least a part of its length (as best shown in Figure 5B ) to provide enhanced rigidity while having a thinner profile to have fewer molding problems. The pushing element 504 can include a main portion 504M, and this main portion includes a contact end 504C, and this contact end can include a cylindrical end configured to contact a pushing element interface feature (such as Figure 6B the pocket 640 of the pivot member 616 shown in, for example). The pushing member 402 can also include a support portion 504S, which is coupled to the main portion 504M, such as being at a right angle thereto to form the T-shaped cross-section. The support portion 504S can be slightly shorter than the main portion 504M, such that the contact end 504C does not impede the rotation in the pocket 640 when the pivot member 616 rotates. The pushing member 402 can include a forging angle on all surfaces to allow for improved removal from the mold.

[0098] Referring now Figures 6A to 6B , an alternative embodiment of the transmitter carrier 614 is illustrated, and this transmitter carrier includes a plurality of fins 660, and these plurality of fins are configured to be received within and slide within the vertical slots 562 formed in the contact member 406. As shown, there are four fins 660. Each pair of the fins 660 can lie in the same vertical plane. Each fin 660 is composed of a vertical connector 662 extending from a base 664. Each vertical connector 662 is connected to a paddle 665, and this paddle extends upward and laterally outward from the connector 662, wherein the outermost portion of the paddle �65 is received within and aligned within the vertical slot 562.

[0099] Further, in the embodiment depicted in Figures 6A to 6B , the transmitter carrier 614 includes enclosed guide grooves 635, 636, which are configured to receive the legs 620L of the insertion device 620, as Figure 6C and Figure 6D shown in. The enclosed guide grooves 635, 636 include open portions facing each other and grooves extending vertically as shown, and have a shape that guides the insertion device 620 during both insertion and retraction. Each of the enclosed guide grooves 635, 636 has a closed portion relative to the open portion, and this closed portion is positioned adjacent to the end of the leg 620L of the insertion device 620.

[0100] As Figure 6C and Figure 6DAs shown in, the insertion device 620 includes a body 620B made of a polymeric 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), and an insertion needle 660I, which may be stainless steel or the like. Other suitable materials may be used. The body 620B includes legs 620L extending from the lateral sides, where the legs 620L are received in the enclosed guiding grooves 635, 636 ( Figures 6A to 6B ). The body 620B includes a recess 620R and a hole (not shown) through an alignment portion 661, the recess being sized to receive a lateral portion 620T of the insertion needle 660I, and the hole receiving a portion 620S with a sensor therethrough. Once inserted, an adhesive or encapsulating compound can be used to secure the lateral portion 620T of the insertion needle 620I into the recess 620R, and thereby secure the insertion needle 620I to the body 620B.

[0101] Figure 7 An exploded view depicting the various components of the biosensor inserter 400. As shown, a push member 402 configured to be firmly grasped by a user, a pivot member 416 (which pivots after insertion of the biosensor to effect retraction of the insertion device 620), first and second portions 414A, 414B of a transmitter carrier, the insertion device 620, and a contact member 406 having a laterally extending peripheral flange 458.

[0102] The foregoing description discloses only exemplary embodiments. Modifications to the devices and methods disclosed above will be apparent to those of ordinary skill in the art, and such modifications fall within the scope of this disclosure document.

Claims

1. A biosensor inserter, comprising: A pushing member, the pushing member including a pushing element; A contact member, the contact member being translatable relative to the pushing member, the contact member including a latch and an internal guiding feature; A transmitter carrier, the transmitter carrier being translatable relative to the contact member, and the transmitter carrier being configured to support a transmitter and sensor assembly during insertion of the biosensor; And A pivot member, the pivot member being configured to pivot on the transmitter carrier, the pivot member including a latch end; And An insertion device, the insertion device being drivable by the pivot member to insert the biosensor, Wherein the internal guiding feature is configured to interface with the latch end of the pivot member, Wherein during insertion of the biosensor in a first part of the stroke, the pivot member is configured to prevent pivoting by sliding the latch end relative to the internal guiding feature of the contact member, and Wherein when the latch end of the pivot member moves past the latch, the pivot member is allowed to pivot and retract the insertion device in a second part of the stroke.

2. The biosensor inserter according to claim 1, wherein the pushing member includes a top member and a bottom member, wherein the bottom member is coupled to the top member, and the bottom member includes a sleeve while the top member includes an inverted cup that can be received over the sleeve.

3. The biosensor inserter according to claim 1, wherein the pushing member includes a first alignment feature and the contact member includes a second alignment feature, and wherein the first alignment feature is configured to interface with the second alignment feature to vertically align the latch end with the latch.

4. The biosensor inserter according to claim 1, wherein the pushing element is configured as a rigid post.

5. The biosensor inserter according to claim 1, wherein the pushing element is configured as a rigid post that extends vertically from a lower side surface of a top portion of the top member.

6. The biosensor inserter according to claim 1, wherein the pushing member includes an inverted cup, and the inverted cup includes a top portion and an annular sleeve portion.

7. The biosensor inserter according to claim 1, wherein the pushing member includes an inclined plate near a lower end of the pushing member, and the contact member includes a first pre-insertion locking feature configured to engage with the inclined plate when combined.

8. The biosensor inserter according to claim 1, wherein the pushing member includes a first pre-insertion locking feature, and the contact member includes a second pre-insertion locking feature configured to engage with the first pre-insertion locking feature.

9. The biosensor inserter according to claim 1, wherein the contact member includes a vertically extending notch.

10. The biosensor inserter according to claim 1, wherein the internal guiding feature includes an inner groove.

11. The biosensor inserter according to claim 1, wherein the transporter carrier includes a limiting stop feature configured to stop the pivoting of the pivot member.

12. The biosensor inserter according to claim 1, wherein the transporter carrier includes a base and side supports disposed on the base, and the side supports include a first guide and a second guide configured to guide the insertion device.

13. The biosensor inserter according to claim 1, wherein the pivot member includes an insertion device support feature configured to support the insertion device during insertion.

14. The biosensor inserter according to claim 13, wherein the insertion device support feature includes a fork configured to receive legs of the body of the insertion device therein.

15. The biosensor inserter according to claim 1, wherein the pivot member includes a push element interface feature, and the push element interface feature includes a pocket configured to interface with a contact end of the push element.

16. The biosensor inserter according to claim 1, wherein the insertion device includes a body portion and an insertion portion, and the body portion includes legs configured to interface with a fork of the insertion device support feature of the pivot member.

17. The biosensor inserter according to claim 1, wherein the insertion device includes a detachable needle cap.

18. The biosensor inserter according to claim 1, wherein the insertion device includes a rib extending circumferentially around the push member.

19. The biosensor inserter according to claim 1, wherein the contact member includes a peripheral flange extending from an inner edge outwardly to an outer edge, the peripheral flange having a W≥5 mm, the peripheral flange extending around at least midway of the perimeter, where W is the width of the peripheral flange.

20. The biosensor inserter according to claim 1, wherein the contact member includes a peripheral flange having an Ac≥500 mm2, where Ac is the contact area of the peripheral flange, and the contact area is configured to contact the skin of a user during insertion.

21. The biosensor inserter according to claim 1, wherein the transporter carrier includes a plurality of fins, and each fin is configured to be received in a vertical slot formed in the contact member.

22. The biosensor inserter according to claim 21, including four fins, and pairs of fins are in the same plane.

23. The biosensor inserter according to claim 21, wherein each of the plurality of fins is constituted by a vertical connector connected to a paddle board, the paddle board facing upward and extending laterally outwardly from the vertical connector, and an outermost portion of the paddle board is received in and aligned within the vertical slot.

24. The biosensor inserter according to claim 1, wherein the transporter carrier includes a closed guide groove configured to receive legs of the insertion device.

25. A biosensor inserter configured to insert a biosensor of a continuously monitored transmitter and sensor assembly, the biosensor inserter comprising: A pushing member having a rigid pushing element and a first alignment feature; A contact member having a latch, a second alignment feature, and an internal guiding feature, the contact member configured to collapse within the pushing member; A transmitter carrier configured to support the continuously monitored transmitter and sensor assembly during insertion of the biosensor; A pivot member configured to pivot on the transmitter carrier, the pivot member including a latch end, and An insertion device supported by the pivot member; And Wherein the internal guiding feature is configured to interface with the latch end of the pivot member, Wherein the first alignment feature of the pushing member is configured to interface with the second alignment feature of the contact member to align the latch end with the latch, and Wherein the pivot member is configured to slide the latch end relative to the internal guiding feature of the contact member and the pivot member is prevented from pivoting during a first portion of the insertion stroke of the biosensor, and Wherein when the latch end of the pivot member moves beyond the latch, the pivot member is allowed to pivot and retract the insertion device during a second portion of the stroke, leaving the implanted biosensor.

Images