Biosensor inserter device and method

Abstract

To improve an inserter apparatus.SOLUTION: A biosensor inserter for inserting a biosensor of a continuous measurement transmitter / sensor assembly includes: a push member with a push element and a first alignment feature part; a contact member including a latch and a second alignment feature part and operating in a nested manner in the push member; a carrier supporting a transmitter / sensor assembly during insertion of the biosensor; a pivot member pivotally supported on the carrier and having a latch end; and an insertion device supported by the pivot member. The first alignment feature part is configured to cooperate with the second alignment feature part so as to make the latch align the latch end. The pivot member is configured to slide against an internal guide feature part. During insertion of the biosensor, a first portion of a stroke prevents pivoting. When the latch end moves past the latch, the pivot member is allowed to pivot in a second portion of the stroke, the device is retracted and the sensor is retained in the implanted state.SELECTED DRAWING: Figure 1D

Description

[Technical field]

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

[0002] The present disclosure relates to an inserter configured for inserting a biosensor that may be part of a continuous glucose monitor (CGM). [Background technology]

[0003] Continuous analyte sensing, such as with continuous glucose monitors (CGMs), has become a routine sensing procedure, especially in diabetes care. Real-time blood glucose measurements, which provide glucose concentrations over time, allow for timely therapeutic interventions, such as insulin administration, to be taken, thus allowing for better management of glycemic status.

[0004] During CGM operation, a biosensor of the transmitter / sensor assembly is inserted subcutaneously and continuously operated within an environment surrounded by tissue and interstitial fluid (ISF). The subcutaneously inserted biosensor transmits a signal to the transmitter of the transmitter / sensor assembly, which signal may be representative of the patient's blood glucose level. These measurements may be taken intermittently and automatically multiple times over a 24-hour period (e.g., every few minutes or at other suitable time intervals).

[0005] The transmitter of the transmitter / sensor assembly is affixed to an outer surface of the user's skin, such as on the abdomen, on the back of the upper arm, or other suitable location, while the biosensor is inserted through the skin to contact the ISF. This skin insertion process may be referred to as "insertion." A device for performing this insertion may be referred to as an "inserter." Summary of the Invention [Problem to be solved by the invention]

[0006] Inserter designs can be complex and expensive to manufacture. Therefore, improvements in the design of the inserter device and its method of operation are desirable. [Means for solving the problem]

[0007] In some embodiments, a biosensor inserter includes a push member with a push element, a contact member translatable relative to the push member, the contact member including a latch, a transmitter carrier translatable relative to the contact member and configured to support a transmitter / sensor assembly during insertion of a biosensor, a pivot member configured to be pivoted on the transmitter carrier, the pivot member including a latch end, and an insertion device actuable by the pivot member to insert the biosensor, wherein during insertion of the biosensor in a first portion of a stroke, the pivot member is prevented from pivoting, and when the latch end of the pivot member moves beyond the latch, the pivot member pivots in a second portion of a stroke to allow retraction of the insertion device.

[0008] In another embodiment, a biosensor inserter configured to insert a biosensor of a continuous measurement transmitter / sensor assembly is provided, the biosensor inserter comprising a push member having a rigid push element and a first alignment feature, a contact member having a latch and a second alignment feature configured for telescopic movement within the push member, a transmitter carrier configured to support the continuous measurement transmitter / sensor assembly during insertion of the biosensor, a pivot member configured to pivot relative to the transmitter carrier, the pivot member having a latch end, and an insertion device supported by the pivot member, the first alignment feature of the push member configured to cooperate with the second alignment feature of the contact member to align the latch end with the latch, the pivot member configured to slide against the internal guide feature of the contact member, and prevented from pivoting during a first portion of a stroke during insertion of the biosensor, and when the latch end of the pivot member moves beyond the latch, the pivot member can pivot during a second portion of a stroke to retract the insertion device to leave the biosensor implanted.

[0009] In another embodiment, a method of using an inserter device to insert a biosensor is presented. The method includes providing a biosensor inserter, the biosensor inserter comprising: a push member comprising a push element; a contact member translatable relative to the push member, the contact member comprising a latch; a transmitter carrier translatable relative to the contact member and configured to support a transmitter / sensor assembly during insertion of the biosensor; a pivot member configured to pivot relative to the transmitter carrier, the pivot member comprising a latch end; and an insertion device actuable by the pivot member; contacting the contact member against a user's skin; and pushing the push member during a first portion of a stroke to cause the push element to contact the pivot member and translate the transmitter carrier to penetrate and insert the insertion device and biosensor into the user's skin, the pivot member being prevented from pivoting during the first portion of the stroke; and continuing to push the push member until the latch end unlatches from the latch, the pivot member pivoting during a second portion of the stroke to allow the insertion device to be retracted while leaving the biosensor implanted.

[0010] Other features, aspects, and advantages of the embodiments according to the present disclosure will become more fully apparent from the following detailed description, claims, and accompanying drawings illustrating several exemplary embodiments. Also, the various embodiments according to the present disclosure may be capable of other and different applications, and some details may be modified in various respects without departing from the scope of the claims and their equivalents. Thus, the following detailed description should be regarded as illustrative in nature, and not restrictive.

[0011] The drawings should be regarded as illustrative in nature and not restrictive. The drawings are not necessarily to scale. Like reference numerals are used throughout the several drawings to denote like elements. [Brief description of the drawings]

[0012] [Figure 1A] FIG. 2 is a side perspective view of a biosensor inserter according to one or more embodiments presented herein. [Figure 1B] FIG. 2 is a bottom perspective view of a biosensor inserter with a needle cover according to one or more embodiments presented herein. [Figure 1C] FIG. 13 is a bottom perspective view of a biosensor inserter with the needle cover removed, exposing the inserter portion of an insertion device according to one or more embodiments presented herein. [Figure 1D] FIG. 2 is a cross-sectional side perspective view of a biosensor inserter showing various components and their interconnections according to one or more embodiments presented herein. [Figure 1E] FIG. 1 is a partial cross-sectional side perspective view of a biosensor inserter showing various components, and a perspective view of a contact member and transmitter carrier assembly, according to one or more embodiments presented herein. [Figure 1F] FIG. 2 is a partially exploded, partially perspective view of a biosensor inserter, otherwise illustrating various components, according to one or more embodiments presented herein. [Figure 1G] 1 is a first side perspective view of a contact member of a biosensor inserter according to one or more embodiments presented herein. FIG. [Figure 1H] 1G according to one or more embodiments presented herein. FIG. 1C is a second side perspective view of the opposing side of the contact member of FIG. [Figure 1I] FIG. 2 is a bottom view of a transmitter carrier of a biosensor inserter according to one or more embodiments presented herein. [Figure 1J] 1J-1J, according to one or more embodiments presented herein, is a cross-sectional side view of the transmitter carrier of FIG. 1I along section line 1J-1J. [Figure 1K] FIG. 2 is a side perspective view of a transmitter carrier of a biosensor inserter according to one or more embodiments presented herein. [Figure 1L] FIG. 2 is a side perspective view of a contact member / carrier assembly of a biosensor inserter according to one or more embodiments presented herein. [Figure 1M] FIG. 2 is a side perspective view of a carrier assembly of a biosensor inserter according to one or more embodiments presented herein. [Figure 1N] 1 is a plan view of a pivot member of a biosensor inserter according to one or more embodiments presented herein. FIG. [Figure 1O] FIG. 1C is a side cross-sectional view of the pivot member of FIG. 1N along section line 1O-1O according to one or more embodiments presented herein. [Figure 1P] 1 is a perspective view of a pivot member according to one or more embodiments presented herein. [Figure 1Q] FIG. 13 is a side view of a transmitter insertion assembly comprising a transmitter / sensor assembly with an insertion device coupled thereto according to one or more embodiments presented herein. [Figure 1R] FIG. 2 is a perspective view of a transmitter insertion assembly according to one or more embodiments presented herein. [Figure 1S] FIG. 1 is a first side view of an insertion device according to one or more embodiments presented herein. [Figure 1T] FIG. 2 is a second side view of an insertion device according to one or more embodiments presented herein. [Figure 1U] FIG. 13 is a side perspective view of an insertion device showing the routing of a biosensor according to one or more embodiments presented herein. [Figure 1V] FIG. 13 is an enlarged partial side cross-sectional view of an insertion device showing the routing of a biosensor according to one or more embodiments presented herein. [Figure 2A] 1A-1C are side cross-sectional views of a biosensor inserter during a step of a biosensor insertion method according to embodiments presented herein. [Figure 2B] 1A-1C are side cross-sectional views of a biosensor inserter during a step of a biosensor insertion method according to embodiments presented herein. [Figure 2C] 1A-1C are side cross-sectional views of a biosensor inserter during a step of a biosensor insertion method according to embodiments presented herein. [Figure 2D] 1A-1C are side cross-sectional views of a biosensor inserter during a step of a biosensor insertion method according to embodiments presented herein. [Figure 2E] 1A-1C are side cross-sectional views of a biosensor inserter during a step of a biosensor insertion method according to embodiments presented herein. [Figure 2F] 1A-1C are side cross-sectional views of a biosensor inserter during a step of a biosensor insertion method according to embodiments presented herein. [Diagram 3] 1 is a flow diagram of a method of using a biosensor inserter to insert a biosensor according to embodiments presented herein. [Figure 4A] FIG. 13 is a top perspective view of an alternative embodiment of a biosensor inserter according to the present disclosure. [Figure 4B] FIG. 4B is a bottom perspective view of the biosensor inserter of FIG. 4A with the transmitter / biosensor assembly removed for illustration purposes, in accordance with the present disclosure. [Figure 5A] 13 is a bottom perspective view of an alternative embodiment of a push member and a push element according to one or more embodiments of the present disclosure. FIG. [Figure 5B] FIG. 13 is a partial plan view of an alternative embodiment of a push element having a T-shaped cross-section according to the present disclosure. [Figure 5C] FIG. 13 is a front perspective view of an alternative embodiment of a contact member with a flange and fin support according to the present disclosure. [Figure 6A] FIG. 13 is a front perspective view of a portion of an alternative embodiment of a transmitter carrier with fins and closure guides according to the present disclosure. [Figure 6B] FIG. 13 is a front perspective view of an alternative two-piece transmitter carrier according to the present disclosure. [Figure 6C] FIG. 1 is a front perspective view of one embodiment of an inserter device according to the present disclosure. [Figure 6D] FIG. 1 is a front perspective view of one embodiment of an insertion needle according to the present disclosure. [Figure 7] FIG. 13 is an exploded front perspective view of an alternative embodiment of a biosensor inserter according to the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0013] In one or more embodiments described herein, a biosensor inserter is presented that can be manufactured inexpensively. The biosensor inserter is configured to implant (insert) a biosensor into human skin. For example, in some embodiments, the biosensor inserter may include a transmitter carrier that holds a transmitter / sensor assembly during insertion of the biosensor, and a push element that translates the transmitter carrier toward the user's skin during a first portion of the biosensor inserter's stroke. In one or more embodiments, the push element may be formed from a rigid material piece that may be integral with or rigidly coupled to the push member. The push element may be offset from a central axis of the biosensor.

[0014] In some embodiments, a pivot member that contacts and operatively drives the insertion device of the biosensor inserter is prevented from pivoting when the transmitter carrier translates toward the user's skin during a first portion of the biosensor inserter's stroke (the insertion portion), but is unlatched to allow pivoting after the biosensor is implanted into the user's skin. When unlatched, the pivot member may pivot during a second portion of the biosensor inserter's stroke, thereby retracting the insertion device (the retraction portion) and leaving the biosensor inserted into the user's skin. Thus, the pivot member does not pivot during the first portion of the stroke.

[0015] These and other structural and functional features of embodiments of the inserter are described below with reference to Figures 1A-7.

[0016] 1A-1C show perspective views of a biosensor inserter 100 according to one or more embodiments presented herein. The biosensor inserter 100 comprises a push member 102, which in the illustrated embodiment is shown as comprising two joined pieces, namely an upper portion 102T and a lower portion 102B joined together. Additionally, the biosensor inserter 100 comprises a contact member 106 that is axially translatable (along an axial axis 105) relative to the push member 102 in the direction indicated by arrow 107. Thus, the contact member 106 can be axially received within the push member 102 and can be nested with the push member 102. The push member 102 is the portion that is contacted and pressed by a user during biosensor insertion. Optionally, the push member 102 can be configured as a single piece.

[0017] As best shown in Figures 1G and 1H, the contact member 106 includes an upper end 106U and a lower end 106L. The lower end 106L may contact the user's skin 113 during insertion and retraction of the insertion device 120 to implant the biosensor 150 (see Figures 2B and 2C) in the user's skin 113 (Figures 2A-2F). Additionally, the contact member 106 includes a latch 109 (Figure 1D), which is a latch surface (lower latch surface) through which the pivot member 116 (Figures 1N-1P) can rotate (Figures 2D-2F) via movement of the latch end 117 (Figures 1L-1M) of the pivot member 116 (Figures 1N-1P), as described further herein. The pivot member 116 is prevented from rotating until the latch end 117 passes the latch 109. The latch 109 (FIG. 1D) of the contact member 106 can be formed as part of the vertically extending cut-out 106C (FIGS. 1A-1C), and the latch 109 can include a circumferentially disposed surface that is wider than the latch end 117 of the pivot member 116. The vertically extending cut-out 106C can be open at the lower end 106L.

[0018] As shown in Figures 1A-1F, the push member 102 comprises an upper member 102T and a lower member 102B. The lower member 102B is coupled to the upper member 102T as shown. The lower member 102B comprises a sleeve-shaped portion, and the upper member 102T comprises an inverted cup that can be received over the sleeve. More specifically, the inverted cup comprises a top portion 121 (Figure 1D) that can comprise a circular flat surface, and an annular sleeve portion 102S. The push element 104 (Figures 1D-1E) extends downwardly from the push member 102 and comprises a contact end 104C. The push element 104 is a rigid member that extends downwardly (as viewed in the orientation of the figures) from a lower surface 121U of the top portion 121 and is provided in contact with the pivot member 116.

[0019] As best shown in FIGS. 1A-1C and 1E, the upper member 102T and the lower member 102B may be coupled together by any suitable means, such as by providing two or more spring tabs 108, each with an inward protrusion 108P that seats within a retention feature 108R, such as a slot or groove, formed in the lower member 102B. The inward protrusions 108P operatively snap-inserted and locked into the respective retention features 108R of the lower member 102B to hold the two parts together as a unitary piece. Optionally, however, the push member 102 may be molded as a unitary piece in some embodiments. Additionally, other means may be used to facilitate a snap-fit ​​connection of the upper member 102T to the lower member 102B or to otherwise couple the upper member 102T and the lower member 102B together. 1F, the push member 102 can include a ramp 128 near its lower end 102L, and the contact member 106 can include an inward protrusion 142, such as a snap-fit ​​hook, configured to engage the ramp 128 after assembly. If multiple inward protrusions 108P are used, there can be a corresponding ramp 128 for each.

[0020] In some embodiments, the push member 102 and / or the contact member 106 may be formed from biodegradable and / or recyclable materials (e.g., 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.

[0021] FIG. 1B illustrates a bottom perspective view of an example biosensor inserter 100 according to one or more embodiments presented herein. With reference to FIG. 1B, the biosensor inserter 100 may include a transmitter / sensor assembly 115 removably attached to a transmitter carrier 114 (see further FIGS. 1C and 1D), such as in a recess 118 (FIG. 1D). The transmitter carrier 114 is axially translatable relative to the contact member 106 and configured to support the transmitter / sensor assembly 115 during insertion of a biosensor 150U (FIGS. 1U, 1V, and 2A-2D). In particular, the transmitter / sensor assembly 115 may include transmitter electronics, a power source, and a sensor assembly including a biosensor 150. Thus, the transmitter / sensor assembly 115 is supported during insertion of the biosensor 150.

[0022] In some embodiments, the transmitter / sensor assembly 115 may comprise a base supporting 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). Examples of transmitter electronics include an analog front end for energizing the analyte sensor and sensing the current passing through the biosensor 150, and may include, for example, an operational amplifier, a current sensing circuit, and the like. Other transmitter circuitry may comprise a processing circuit, such as an analog-to-digital converter, for digitizing the current signal, a memory for storing the digitized current signal, a controller, such as a microprocessor or microcontroller, for optionally computing an analyte concentration value based on the measured current signal, and a transmitter circuit for transmitting the analyte concentration value to an external device (e.g., a smartphone or other suitable external device for storing and / or displaying the analyte concentration). In some embodiments, the transmitter electronics may form an independent transmitter unit, which may be reusable, and may be combined with a sensor unit in a base unit having a power source and a sensor assembly. This base unit may be disposable. In such an embodiment, the transmitter unit may be attached to the base unit before or after the biosensor 150 is inserted using the biosensor inserter 100 .

[0023] In some embodiments, the sensor (e.g., biosensor 150) used in the transmitter / sensor assembly 115 may include two electrodes and a bias voltage may be applied between the electrode pair. In such an example, a current may be measured by the sensor. In other embodiments, the sensor may include three electrodes, such as a working electrode, a counter electrode, and a reference electrode. For example, in such an example, a bias voltage may be applied between the working electrode and the reference electrode and a current may be measured through the working electrode. The sensor may include an active area that includes one or more chemicals that undergo an analyte-enzyme reaction with the product to be detected. The enzyme is immobilized on one or more electrodes to cause a reaction (e.g., a redox reaction) with the analyte and generate a current in the electrode or electrodes. For example, the reaction may affect the charge carrier concentration and the time-dependent impedance of the sensor. Examples of chemicals include glucose oxidase or glucose dehydrogenase, etc. In some embodiments, a mediator such as ferricyanide or ferrocene may be used in the active area. In one or more embodiments, the sensor may include a microneedle or a plurality of microneedles, such as a microneedle array. Generally, analytes that may be detected and / or measured using a suitable sensor include glucose, cholesterol, lactate, uric acid, alcohol, etc. An analyte is defined herein as a constituent, substance, chemical species, or chemical moiety that can be measured by an analytical procedure.

[0024] The example biosensor 150 (FIG. 1U) can be any suitable implantable sensor that can be implanted into the user's skin 113 (FIG. 2A), such as a strand-shaped sensor that can be received within the insertion portion 120I of the insertion device 120 and that can sense an analyte concentration reading in the interstitial fluid beneath the skin 113, such as a glucose sensor or a lactate sensor.

[0025] As shown in FIG. 1Q and FIG. 1R, in some embodiments, a transmitter insertion assembly 119 is provided which is an assembly of an insertion device 120 (shown in FIG. 1S-FIG. 1V) and a transmitter / sensor assembly 115. The transmitter insertion assembly 119 can include a needle cover 124, which can be removed by a user prior to performing the insertion method. The needle cover 124 is detachable from the insertion device 120 and protects the insertion portion 120I (e.g., the needle portion) of the insertion device 120. Thus, the needle cover 124 is detachable from a thread or other snap-fit ​​feature 120T formed on the body 120B of the insertion device 120. Other configurations of the needle cover 124 may be used.

[0026] As previously mentioned, biosensor inserter 100 further includes a pivot member 116 configured to pivot on and relative to transmitter carrier 114. Pivot member 116 may include a latch end 117 on a first end and an insertion device support feature 139 on an opposite end from the first end, as best shown in FIGS. 1N-1P. Insertion device support feature 139 is configured to contact, support, and drive (insert and retract) insertion device 120 during the insertion method.

[0027] In some embodiments, the insertion device support feature 139 comprises a fork 139F configured to receive a leg 120L (see FIGS. 1Q-1U) of the body 120B of the insertion device 120. The fork 139F can comprise a first extending slot that extends across the entire lateral width of the pivot member 116 and may have an open end on an end opposite the latch end 117 of the pivot member 116, thus forming the fork 139F. The upper prong 139FU and the lower prong 139FL of the fork 139F can be configured to receive a leg 120L of the body 120B therebetween. The stem 120S (FIGS. 1S-1U) of the body 120B from which the leg 120L extends laterally can be received in and through the vertical gap 139C (FIGS. 1N-1P). A second extending slot may extend vertically through at least the lower fork member 139FL to intersect with the laterally extending slot to form a vertical gap 139C. These slots may be sized to receive the legs 120L and stem 120S of the body portion 120B of the insertion device 120. As used herein, upper and lower refer to the orientation shown in FIG. 2B, although it should be understood that the pivot member 116 and other elements may be oriented in other orientations during use.

[0028] The pivot member 116 may include one or more pivot features that enable the pivot member 116 to pivot relative to the transmitter carrier 114. For example, the pivot member 116 may include a laterally extending feature 125 (e.g., a post) that cooperates with holes 127 (see FIG. 1K) in a first side support 135 and a second side support 136 of the transmitter carrier 114 to form a pivot axis 125A. Thus, the pivot member 116 is pivotable about the pivot axis 125A and is pivotally supported on the transmitter carrier 114.

[0029] The pivot location of the pivot member 116 may be formed between a first end and an opposite end of the pivot member 116. For example, the pivot axis 125A (FIG. 1N) may be formed by a laterally extending feature 125, such as a cylindrical post extension, protruding from each side of the body of the pivot member 116. The laterally extending feature 125 may be received within a hole 127 (FIGS. 1J-1M) formed in the side supports 135, 136 of the transmitter carrier 114. The pivot member 116 may include a push element interlocking feature 140, which may include a pocket or other interlocking feature formed between the pivot axis 125A and the latch end 117 configured to interlock and contact the contact end 104C of the push element 104. Other suitable laterally extending features may be used to form the pivot. Other pivot mechanisms, such as a removable axle, may also be used.

[0030] In some embodiments, the transmitter carrier 114 and / or the pivot member 116 may be formed from 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), etc. Other materials may be used for the transmitter carrier 114 and / or the pivot member 116.

[0031] In operation, the insertion device 120 can be actuated by contact with the pivot member 116 during an insertion stroke to insert the biosensor 150 into the user's skin 113, as shown in FIGS. 2B and 2C. The insertion device 120 can be actuated by receiving the legs 120L of the body 120B in the forks 139F of the pivot member 116. Additionally, each leg 120L can include a rectangular portion located at each of their outer ends that is received in guides 135G, 136G (FIG. 1M) of the transmitter carrier 114. These guides 135G, 136G can be vertically oriented slots and can be open at the top end. The fit between the rectangular portions and the guides 135G, 136G can be a slip fit, which can help prevent rotation of the insertion device 120 during insertion. Thus, guides 135G, 136G and the rectangular ends on leg 120L cooperate to form an anti-rotational support along an axis that passes laterally through leg 120L. Transmitter carrier 114 may further include a convex alignment member 138V (FIGS. 1I, 1K, and 1M), such as a vertically extending rib (e.g., the rounded rib shown), that is configured to cooperate with a concave alignment member 138C of contact member 106, such as the recess shown in FIG. 1L.

[0032] As best shown in FIGS. 1D and 1E, the contact member 106 may be configured to be concentric with and nest with the push member 102. In some embodiments, the push member 102 may include a first alignment feature 122 (see FIGS. 1E and 2A), such as a vertically extending groove or recess, and the contact member 106 may include a second alignment feature 123 (FIG. 2A), such as a vertically extending rib, that interfaces with the first alignment feature 122. Such alignment features 122, 123 may hold the push member 102 and the contact member 106 in rotational alignment, thereby preventing rotation of the contact member 106 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 may be cylindrical, elliptical, oblong, oval, or any other suitable shape in cross section. In some embodiments, the push member 102 and the contact member 106 may not be concentric.

[0033] More specifically, the transmitter carrier 114 shown in Figures 1I-1M is configured to support the transmitter / sensor assembly 115 during insertion of the biosensor 150 of the transmitter / sensor assembly 115. The transmitter carrier 114 may be sized to fit within the contact member 106 as shown in Figure 1L. Figure 1L shows an assembly 141 of the contact member 106, the transmitter carrier 114, the pivot member 116, and the insertion device 120.

[0034] 1A-1E, in some embodiments, the contact member 106 may include a first pre-insertion locking feature 142 configured to hold the contact member 106 against the push member 102 until a certain preset axial force is exceeded. After the preset force is exceeded, the contact member 106 may move axially further into the push member 102. As described below with reference to FIGS. 2A-2F, for example, the first pre-insertion locking feature 142 may be configured to prevent the push member 102 from sliding over the contact member 106 prior to insertion by extending into a second pre-insertion locking feature 144, such as, for example, a window as shown or a groove formed in the push member 102. However, after the preset force is overcome by application of an axial force F to the push member 102 by the user, the first pre-insertion locking feature 142 flexes and is permitted to move axially within and along the inner surface of the push member 102, thereby permitting relative axial sliding movement of the contact member 106 into the push member 102. The first pre-insertion locking feature 142 may be a spring tab with a hook or the like seated in a groove or slot as shown in FIG. 1E. Once the preset force is overcome, the axial force F may change slightly over the remainder of the stroke.

[0035] FIG. 1F is an exploded, partially cutaway, side perspective view of an exemplary biosensor inserter 100, with portions of the outer member 102 and the inner member 106 removed for illustration, according to an embodiment presented herein. FIGS. 1F and 1G show an internal guide feature 132 formed on an inner surface of the contact member 106 along which an end of the pivot member 116 (e.g., flat end 116E, FIG. 1O) may slide axially during at least a portion of a stroke of the insertion method, as described further herein. The guide feature 132 may be a groove having a flat bottom that is slightly wider than the width of the pivot member 116. The guide feature 132 may intersect with the latch 109 (FIG. 1G) at its lower end. The internal guide feature 132 may be axially disposed to receive the end 116E of the pivot member 116 and prevent rotation of the pivot member 116 during a first portion of the stroke. Rather than rotating, end 116E slides vertically along guide feature 132 and is prevented from rotating. It should be noted that other types of internal guide features 132 may be used. For example, inner member 106 may have a protruding alignment feature, such as a rib, received in a groove formed in the end of pivot member 116 to guide pivot member 116.

[0036] 1D, the transmitter carrier 114 may be formed from a cylindrical body including a base 134 that is used to support the transmitter / sensor assembly 115 during insertion (as described further herein). The base 134 is also coupled to a support structure that is configured to support the pivot member 116. As best shown in FIGS. 1J-1K, the support structure may include a first support 135 having a first guide 135G and a second support 136 having a second guide 136G. The guides 135G and 136G may include slots that may be axially oriented and extend therethrough and may be used to guide the insertion device 120 (FIGS. 1S-1U) during an insertion method as described further herein. The insertion device 120 slides into the insertion device support feature 139 of the pivot member 116 (e.g., into the fork 139F) and further into the guides 135G and 136G of the first and second side supports 135 and 136 that straddle the pivot member 116.

[0037] As best shown in FIG. 1D, the push element 104 may extend downward from the lower surface 121U of the top portion 121 and may include a contact end 104C. The push element 104 may be substantially rigid and may extend generally perpendicularly from the lower surface 121U and may be offset from the axial axis 105 as shown. The push element 104 may include a contact end 104C that contacts and presses against the pivot member 116 during the insertion method. In some embodiments, the contact end 104C may include a cylindrical end portion that contacts the push element interlocking feature 140 (e.g., a pocket as shown in FIG. 1L). During insertion, the push element 104 does not substantially bend or deform, such that by pressing against the push member 102, the contact member 106 telescopes within the push member 102 and translates in a linear direction relative to both the pivot member 116 and the transmitter carrier 114 toward the user's skin 113 during the insertion portion of the stroke.

[0038] Exemplary dimensions of the push element 104 range from 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 push element 104 and pivot member 116 may 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.

[0039] 2A-2F, the assembly and operation of the biosensor inserter 100 (insertion method) will now be described. These figures show side cross-sectional views of the biosensor inserter 100 during an insertion method of a biosensor 150 according to embodiments presented herein.

[0040] To assemble the biosensor inserter 100, a transmitter insertion assembly 119, comprised of a transmitter / sensor assembly 115 (FIGS. 1Q-1R) with an insertion device 120 (FIGS. 1S-1V), is inserted from the bottom, such that the body 120B of the insertion device 120 advances along the path indicated by dashed arrow 147 in FIG. 1J through aperture 145 (FIG. 1I) and past slot end 146 into guides 135G, 136G of the transmitter carrier 114. Thus, the end of leg 120L is received in slot end 146 and advances upward and to the right in FIG. 1J into guides 135G, 136G. Once the transmitter insertion assembly 119, consisting of the transmitter / sensor assembly 115 and the insertion device 120, is properly positioned within the guides 135G, 136G, the transmitter insertion assembly 119 may be held in place within the transmitter carrier 114 using any suitable quick release feature, such as, for example, a light interference fit within the recess 118 (see FIG. 1D ) or possibly a small amount of double-sided adhesive tape or a suitable low-strength adhesive.

[0041] Next, the fork 139F (FIG. 1M) of the insertion device support feature 139 of the pivot member 116 is received over the leg 120L and the laterally extending feature 125 of the pivot member 116 snaps into the holes 127 in the side supports 135, 136 to form a pivot aligned with the pivot axis 125A.

[0042] Next, a carrier assembly 137 (FIG. 1M) comprised of a pivot member 116, an insert member 120, and a transmitter carrier 114 having a transmitter / sensor assembly 115 is inserted into the contact member 106 to form an assembly 141 as shown in FIG. 1L. The carrier assembly 137 may be inserted into the bottom of the contact member 106 until a first stop feature 148 (FIGS. 1I-1J) of the transmitter carrier 114 contacts one or more second stop features 151 (see FIGS. 1G and 1H) formed at the end of the cutout portion 106C of the contact member 106. Other suitable stop features may be used to limit the degree to which the carrier assembly 137 may be inserted into the contact member 106. A slight interference fit may be provided between the exterior surface of the carrier assembly 137 and the interior surface of the contact member 106 to retain the assembly 137 within the contact member 106.

[0043] Some or all of the push member 102 may then be placed over the assembly 141 (FIG. 1L) as shown in FIG. 1D. This push member 102 may be placed by first placing the lower portion 102B over the assembly 141 until the first pre-insertion locking feature 142 snaps into the second pre-insertion feature 144. For example, the first pre-insertion locking feature 142 can be a snap-fit ​​hook and the second pre-insertion feature 144 can be a slot or groove.

[0044] The top portion 102T may then be placed over the bottom member 102B. After proper alignment, two or more spring tabs 108, each with an inward protrusion 108P, may be seated within a respective retention feature 108R. After placement, the push element 104 is aligned with, and is adjacent to or just in contact with, the push element interlocking feature 140 of the pivot member 116. As shown, the contact member 106 is sized to fit within the push member 102, and may have, for example, a strong slip fit or even a light interference fit.

[0045] 1D, 1I, 1J, and 1U, the insertion device 120 has a main body portion 120B that sits within an insertion device support feature 139 (e.g., fork 139F) of the pivot member 116, and an insertion portion 120I that can extend from the transmitter carrier 114 through an aperture 145 (FIG. 1I) in the base 134 of the transmitter carrier 114. The insertion portion 120I of the insertion device 120 can have a sharp end (FIG. 1U) that pierces the user's skin 113 (FIGS. 2A-2F) to introduce the biosensor 150 into the user's subcutaneous region 113S as described further herein. The insertion portion 120I may also be referred to as an insertion shaft, needle, trocar, sharp, or the like. After the insertion portion 120I is pulled back, the biosensor 150 received in an opening 150O (e.g., a slot, elongated cavity, or groove as shown in Figures 1U and 1V) formed along the length of the insertion portion 120I is placed within the user's subcutaneous region 113S.

[0046] 2A, the aperture 145 in the base 134 of the transmitter carrier 114 is positioned and / or aligned below the guides 135G, 136G of the first and second supports 135, 136 so that the insertion portion 120I remains in a generally vertical orientation (and / or generally perpendicular to the area into which the insertion portion 120I will be inserted) during insertion. The body portion 120B of the insertion device 120 may include a flange 120F (FIGS. 1S-1V) that may cooperate with a top surface of the transmitter / sensor assembly 115 to act as an alignment guide to help achieve a generally vertical orientation of the insertion portion 120I relative to the transmitter.

[0047] The insertion portion 120I of the insertion device 120 may be made of a metal, such as stainless steel, or a 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 pressed metal sheet part folded into a U-shaped profile cross-section, a molded / cast metal part with a U-shaped profile cross-section, or a solid metal cylinder with a channel etched or ground to give a U-shaped cross-section. Other insertion portion shapes may be used that allow insertion and retraction while still retaining the implanted biosensor 150.

[0048] The main body portion 120B of the insertion device 120 may be formed from plastic, 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), etc. Other suitable materials may be used.

[0049] 1U and 1V, biosensor 150 is received within opening 150O of insertion portion 120I, extends along the length of insertion portion 120I, passes into a passageway 152 formed in threaded portion 102T, and then exits laterally from passageway 152 for coupling to a connector, electronic panel board, or similar electronic component 154 that comprises or is coupled or configured to couple to the transmitter electronics of transmitter / sensor assembly 115. Thus, following insertion of insertion portion 120I into and then withdrawal of insertion portion 120I from the user's skin 113, biosensor 150 may be removed from passageway 152 and opening 150O to remain in place.

[0050] The operation of the biosensor inserter 100 will now be described with reference to Figures 2A-2F and 3. These figures show a flow diagram of a method 300 of using the biosensor inserter 100 to insert a biosensor 150 according to embodiments presented herein.

[0051] In operation, the transmitter / sensor assembly 115 (shown in dashed lines in FIGS. 2A-2F ) can be removably coupled to the transmitter carrier 114 and in some embodiments can be positioned within a recess 118 in a lower region of the transmitter carrier 114. The transmitter / sensor assembly 115 includes an adhesive layer for adhering the transmitter / sensor assembly 115 to the user's skin 113 after retraction of the insertion device 120. However, it should be apparent that the recess is optional and the transmitter / sensor assembly 115 may simply be removably attached to the lower region of the transmitter carrier 114 by any suitable means.

[0052] 3, the needle cover 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, such as on the upper arm, abdominal area, or other location suitable to avoid insertion into muscle. This is shown in FIG. 2A.

[0053] To initiate insertion, a force F is applied by the user to the push member 102, causing it to slide over the contact member 106 and move towards the insertion site 110. Movement of the push member 102 over the contact member 106 causes the push element 104 to contact the push element interlocking feature 140 (see further FIGS. 1N-1P) of the pivot member 116, thereby translating and moving the transmitter carrier 114 and pivot member 116 towards the insertion site 110 as shown in FIG. 2B. At this time, the latch end 117 moves linearly relative to and towards the latch 109 of the contact member 106, while the end 116E slides along the guide feature 132.

[0054] According to insertion method 300, such axial movement is possible after the applied force F is sufficient to deflect the first pre-insertion locking feature 142 (e.g., a hook as shown in FIG. 1A ) inwardly and out of the pre-insertion locking feature 144 (e.g., a slot or groove) of the push member 102. During this first portion of the stroke of insertion method 300, the pivot member 116 is prevented from pivoting by end 116E contacting a wall surface (e.g., inner guide groove 132) of the contact member 106 as the transmitter carrier 114 and pivot member 116 translate toward the insertion site 110.

[0055] As shown in FIG. 2C, the transmitter carrier 114 and pivot member 116 continue to move toward the insertion site 110 until the insertion portion 120I contacts and advances into the insertion site 110 and until a bottom surface of the transmitter / sensor assembly 115 contacts the skin 113 surrounding the insertion site 110. In some embodiments, the bottom surface of the transmitter / sensor assembly 115 may be adhered (e.g., by an adhesive material) to the user's skin 113 surrounding the insertion site 110. The insertion portion 120I and biosensor 150 advance into the insertion site 110 where the biosensor 150 may contact interstitial fluid in the subcutaneous region 113S. The biosensor 150 may be positioned, for example, 4-6 mm into the skin 113, although other depths may be used.

[0056] 2C, end 116E of pivot member 116 remains in contact with an inner surface of inner member 106 (e.g., guide surface 132 of latch 109) and is prevented from pivoting during the first portion of its stroke. Thus, pivot member 116 is prevented from pivoting during insertion of biosensor 150. This causes insertion portion 120I to remain in a fixed position relative to pivot member 116 and transmitter carrier 114, with flange 120F resting against the top surface of transmitter / sensor assembly 115.

[0057] 2D, after insertion of the biosensor 150 (and / or adhesion of the transmitter / sensor assembly 115 to the skin 113 surrounding the insertion site 110), the outer member 102 continues to move over the inner member 106 toward the insertion site 110 on the second portion of its stroke. When the latch end 117 of the pivot member 116 moves past the latch 109 at the beginning of the second portion of its stroke, the push by the push element 104 allows the pivot member 116 to pivot and rotate under the latch 109 and into the cutout portion 106C. This pivoting causes the insertion device 120 to be retracted on the second portion of its stroke.

[0058] During retraction, the pivot member 116 pivots on the transmitter carrier 114 due to the force applied by the push element 104 against the pivot member 116 (as shown in FIG. 2D). As this occurs, the insertion portion 120I of the insertion device 120 is retracted from the insertion site 110 and the flange 120F moves away from the transmitter / sensor assembly 115. As the outer member 102 continues to move over the inner member 106 towards the insertion site 110, the push element 104 continues to press against the pivot member 116. Eventually, as shown in FIG. 2F, the pivot member 116 pivots sufficiently that the insertion device 120 is completely removed from the user's skin 113 and the implanted biosensor 150 is placed in the skin 113. As the push member 102 is further pushed, the insertion device 120 is retracted completely above the aperture 145. As such, the insertion portion 120I of the insertion device 120 cannot be accidentally reinserted into the insertion site 110. Furthermore, as the push member 102 continues to move toward the insertion site 110, after insertion, the axial stop feature 155 (FIGS. 1J and 2F) of the transmitter carrier 114 can contact the pivot member 116 and prevent the insertion device 120 from being further retracted.

[0059] The biosensor inserter 100 may then be removed, leaving the transmitter / sensor assembly 115 in place with the bottom surface of the transmitter / 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 shown in FIG. 2F). In some embodiments in which the push member 102 and contact member 106 are formed from renewable or biodegradable materials, these components may be recycled or composted.

[0060] 3, one embodiment of a method 300 of using a biosensor inserter (e.g., biosensor inserter 100) to insert a biosensor (e.g., biosensor 150) is described. The method 300 includes, at block 302, providing a biosensor inserter 100. The biosensor inserter 100 includes a push member (e.g., push member 102) having a push element (e.g., push element 104), a contact member (e.g., contact member 106) translatable relative to the push member, the contact member having a latch (e.g., latch 109), a transmitter carrier (e.g., transmitter carrier 114) translatable relative to the contact member and configured to support a transmitter / sensor assembly (e.g., transmitter / sensor assembly 115) during insertion of a biosensor (e.g., biosensor 150), a pivot member (e.g., pivot member 116) configured to pivot relative to the transmitter carrier, the pivot member having a latch end (e.g., latch end 117), and an insertion device (insertion device 120) actuable by the pivot member.

[0061] The method 300 further includes contacting a contact member (e.g., contact member 106) against the user's skin (e.g., skin 113 as illustrated in FIG. 2A) at block 304. After this contact, at block 306, pushing a push member (e.g., push member 102) to contact the push element 104 against the pivot member 116 (e.g., at a push element interfacing feature 140 such as a pocket) and translating the transmitter carrier (e.g., axially translating the transmitter carrier 114 within the contact member 106) to insert the insertion device (e.g., insertion portion 120I of the insertion device 120) and the biosensor 150 through the user's skin 113. The pivot member (e.g., pivot member 116) is prevented from pivoting. In particular, the pivot member (e.g., pivot member 116) is prevented from pivoting over a first portion of the stroke.

[0062] Additionally, the method 300 further includes continuing to push the push member (e.g., push member 102) until unlatching of the latch end (e.g., latch end 117) from the latch (e.g., latch 109 of the contact member 106) occurs at block 308. The pivot member 116 pivots, allowing the insertion device 120 to be pulled back while leaving the biosensor 150 implanted in the user's skin 113. This unlatching occurs after a first portion of the stroke when the push element 104 pushes against the pivot member 116, resulting in the latch end 117 moving past the latch 109 and allowing it to rotate downwardly therefrom. Pivoting of the pivot member 116 during a second portion of the stroke of the push member 102 operatively retracts the insertion portion 120I of the insertion device 120 from the user's skin 113, leaving the implanted sensor 150 in place.

[0063] 4A and 4B show an alternative embodiment of the biosensor inserter 400. This embodiment has several advantageous ergonomic and / or functional features compared to the embodiments previously described herein. Specifically, the overall shape, including the shape of the push member 402 and the contact member 406, is elongated in cross section compared to the round shape of the embodiment of the biosensor inserter 100 shown in FIGS. 1A-1C. This elongated shape allows for a more ergonomic grip of the push member 402. Furthermore, the elongated shape allows for a more compact overall configuration, given that the transmitter / sensor assembly 115 (not shown in FIG. 4B) tends to be constructed from rectangular circuit components. To further improve the ergonomic grip of the push member 402, the insertion device 400 may include a number of ribs 454 extending circumferentially around the upper periphery of the push member 402. As shown, the ribs 454 may extend more than 150 degrees around the top portion of the push member 402. Similar ribs 454 are provided on opposite sides of the push member 402. As shown, three ribs are formed on each side by molding and extend circumferentially around the periphery of the push member 402 and connect to end ribs 455A, 455B. End ribs 455A, 455B may be vertically aligned as shown. The height of the ribs 454 may vary to achieve an arcuate vertical gripping profile, best illustrated as configured on end ribs 455A, 455B. The height of the ribs 454 may range, for example, from 1 mm to 3 mm for each rib 454. The width of the ribs 454 may range, for example, from 1 mm to 5 mm.

[0064] 4A-4B and 5C, an alternative embodiment of the contact member 406 is presented that may include a peripheral flange 458. The peripheral flange 458 may extend outwardly from part or all of the body portion 406B of the contact member 406. As best shown in FIG. 4B, the peripheral flange 458 may extend outwardly from an inner edge 458i to an outer edge 458o by a width W measured along the plane of the flange 458. The width W may be 5 mm or greater along at least a portion of this periphery, where W is the width of the peripheral flange 458. In some embodiments, the peripheral flange 458 may extend along the entire circumferential outer edge and may have a width of 5 mm or greater at all locations. The inner edge 458i may include several recesses and protrusions for engaging the transmitter carrier 414. In some embodiments, the contact member 406 with the peripheral flange 458 may have a width of Ac≧500 mm. 2 where Ac is the contact area of ​​the peripheral flange 458 configured to contact the user's skin during biosensor insertion.

[0065] 5A and 5B, the push element 504 extending from the lower surface 521U of the push member 402 can have a T-shaped cross-section along at least a portion of its length, as best shown in FIG. 5B, which can allow for a reduced profile while improving stiffness, thereby further reducing molding challenges. The push element 504 can have a main portion 504M with a contact end 504C, which can have a cylindrical end configuration that contacts a push element interlocking feature (e.g., pocket 640 of the pivot member 616 as shown in FIG. 6B). The push member 402 can also have a support portion 504S, which is coupled to the main portion 504M, such as at a right angle, to form a T-shaped cross-section. The support portion 504S can be somewhat shorter than the main portion 504M, so that the contact end 504C does not impede rotation within the pocket 640 as the pivot member 616 rotates. The push member 402 may have draft on all surfaces to improve removal from the mold.

[0066] 6A-6B, an alternative embodiment of a transmitter carrier 614 is shown that includes a plurality of fins 660 configured to be received and slid within vertical slots 562 formed in the contact member 406. As shown, there are four fins 660. Each pair of the fins 660 may be located in the same vertical plane. Each fin 660 is comprised of a vertical connector 662 extending from a base 664. Each vertical connector 662 is coupled to a paddle 665 that extends upwardly and laterally outwardly from the connector 662, with an outermost portion of the paddle 665 being received and aligned within the vertical slots 562.

[0067] 6A-6B, the transmitter carrier 614 further includes closed guide grooves 635, 636 configured to receive the legs 620L of the insertion device 620 as shown in FIGS. 6C and 6D. The closed guide grooves 635, 636 include open portions facing each other, extend vertically as shown, and are shaped to guide the insertion device 620 during both insertion and retraction. Each closed guide groove 635, 636 includes a closed portion on opposite sides of the open portion and is positioned adjacent to an end of the leg 620L of the insertion device 620.

[0068] As shown in Figures 6C and 6D, the insertion device 620 comprises a main 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 can be used. The main body 620B comprises legs 620L extending from the sides, which are received in closed guide grooves 635, 636 (e.g., Figures 6A-6B). The main body 620B comprises a recess 620R sized to receive the lateral portion 620T of the insertion needle 660I, and a hole (not shown) through the alignment portion 661 through which the sensor-carrying portion 620S is received. After insertion, an adhesive or potting compound may be used to secure the lateral portion 620T of the insertion needle 620I within the recess 620R, and thus secure the insertion needle 620I relative to the main body 620B.

[0069] 7 shows an exploded view of the various components of the biosensor inserter 400. Shown are a push member 402 configured to be firmly gripped by a user, a pivot member 416 that pivots to effectuate retraction of the insertion device 620 after insertion of the biosensor, first and second parts of the transmitter carriers 414A, 414B, the insertion device 620, and a contact member 406 having a laterally extending peripheral flange 458.

[0070] The foregoing description discloses merely exemplary embodiments. Modifications of the above disclosed apparatus and methods which fall within the scope of the present disclosure will be readily apparent to those of ordinary skill in the art. [Explanation of symbols]

[0071] 100 Biosensor Inserter 102 Push member, outer member 102B Lower part, lower member 102L lower end 102S Annular sleeve part 102T Upper part, upper member, threaded part 104 Push Elements 104C Contact end 105 Axial axis 106 Contact member, inner member 106C Vertical extension notch, cutout part 106L lower end 106U upper end 107 Arrow 108 tabs 108P Inward protrusion 108R Retention Features 109 Latch 110 Insertion Site 113 Skin 113S Subcutaneous area 114 Transmitter Carrier 115 Transmitter / Sensor Assembly 116 Pivot member 116E flat end, end 117 Latch end 118 Recess 119 Transmitter Insertion Assembly 120 Insertion device, insertion member 120B main body, main body part, main main body part 120F flange 120I Insertion part 120L Leg 120S stem 120T Snap-Fit Features 121 Top part 121U bottom 122 first alignment feature 123 Second alignment feature 124 Needle cover 125 Lateral Extending Feature 125A pivot axis 127 holes 128 Slope 132 guide feature, inner guide groove, guide surface, internal guide feature 134 Base 135 First Side Support 135G First Guide 136 Second Side Support 136G Second Guide 137 Carrier Assembly 138C Concave alignment member 138V Convex alignment member 139 Insertion Device Support Features 139C Vertical Gap 139F Fork 139FL Lower prong, lower fork member 139FU Upper prong 140 Push element linking feature 141 Assembly 142 first pre-insertion locking feature, inward protrusion 144 second pre-insertion lock feature, second pre-insertion feature 144 Pre-insertion locking feature 145 Aperture 146 Dashed Arrow 146 Slot End 148 First Stop Feature 150 Biosensors 150O aperture 150U Biosensor 151 Second Stop Feature 152 Passage 154 Electronic Components 155 Axial Stop Feature 400 Biosensor Inserter, Insertion Device 402 Push member 406 Contact member 406B Main body part 414 Transmitter Carrier 414A Transmitter Carrier 414B Transmitter Carrier 416 Pivot member 454 Rib 455A End Rib 455B End Rib 458 Peripheral flange 458i Inner Edge 458o outer edge 504 Push element 504C contact end 504M Main parts 504S support part 521U bottom side 562 Vertical Slot 614 Transmitter Carrier 616 Pivot member 620 Insertion Device 620B main body 620I Insertion Needle 620L Leg 620R Recess 620S Sensor carrying part 620T Lateral section 635 Closed guide groove 640 Pocket 660 Fin 661 Alignment part 660I Insertion Needle 662 Vertical Connector 664 Base 665 Paddle

Claims

1. a biosensor inserter configured to insert a biosensor of the continuous measurement transmitter and sensor assembly, a push member having a rigid push element and a first alignment feature; a contact member having a latch and a second alignment feature, the contact member configured to telescopically move within the push member; a transmitter carrier configured to support the continuous measurement transmitter and the sensor assembly during insertion of the biosensor; a pivot member configured to be pivotally supported on the transmitter carrier, the pivot member having a latch end; an insertion device supported by the pivot member; Equipped with the first alignment feature of the push member is configured to cooperate with the second alignment feature of the contact member to align a latch end with the latch; the pivot member is configured to slide relative to an internal guide feature of the contact member and is prevented from pivoting during a first portion of a stroke during insertion of the biosensor; the pivot member is configured to pivot on a second portion of its stroke when the latch end of the pivot member moves beyond the latch, allowing the insertion device to be retracted to leave the biosensor in an implanted state.

2. The biosensor inserter of claim 1 , wherein the contact member includes an internal guide feature configured to cooperate with the latch end of the pivot member.

3. The biosensor inserter of claim 2 , wherein the internal guide feature comprises an internal groove.

4. The biosensor inserter of claim 1 , wherein the transmitter carrier comprises a limit stop feature configured to stop pivoting of the pivot member.

5. 2. The biosensor inserter of claim 1, wherein the transmitter carrier comprises a base and a side support disposed on the base, the side support comprising a first guide and a second guide configured to guide the insertion device.

6. The biosensor inserter of claim 1 , wherein the pivot member comprises an insertion device support feature configured to support the insertion device during the insertion.

7. The biosensor inserter of claim 6 , wherein the insertion device support feature comprises a fork configured to receive a leg of a body of the insertion device therein.

8. The biosensor inserter of claim 1 , wherein the pivot member comprises a push element coupling feature comprising a pocket configured to couple with a contact end of the rigid push element.

9. The biosensor inserter of claim 1 , wherein the insertion device comprises a body portion and an insertion portion, the body portion comprising a leg configured to cooperate with a fork of an insertion device support feature of the pivot member.

10. The biosensor inserter of claim 1 , wherein the insertion device comprises a removable needle cover.

11. The biosensor inserter of claim 1 , wherein the insertion device comprises a rib extending circumferentially along the push member.

12. 2. The biosensor inserter of claim 1, wherein the contact member comprises a peripheral flange having a width W≧5 mm extending outward from an inner edge to an outer edge, the peripheral flange extending along at least a portion of the periphery, and W is the width of the peripheral flange.

13. The contact member has a structure in which Ac≧500 mm 2 13. The biosensor inserter of claim 1, further comprising a peripheral flange having a contact area A c configured to contact a user's skin during insertion.

14. 10. The biosensor inserter of claim 1, wherein the transmitter carrier comprises a plurality of fins, each fin configured to be received within a vertical slot formed in the contact member.

15. 15. The biosensor inserter of claim 14, comprising four of the fins, pairs of the fins being coplanar.

16. 15. The biosensor inserter of claim 14, wherein each of the plurality of fins is comprised of a vertical connector that connects to a paddle that extends upwardly and laterally outwardly from the vertical connector, an outermost portion of the paddle being received and aligned within the vertical slot.

17. The biosensor inserter of claim 1 , wherein the transmitter carrier comprises a closed guide groove configured to receive a leg of the insertion device.

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