Biosensor inserters and methods with reduced medical waste

Abstract

A biosensor inserter is configured to insert a biosensor. The biosensor inserter includes a push member including a receiver, a contact member translatable relative to the push member, and a trocar holder having a sheath configured to receive a trocar assembly including a trocar therein. The trocar holder is configured to be insertable into, and removable from, the receiver. Thus, an amount of medical waste can be minimized by discarding only the removable trocar holder and trocar assembly after use. System and method embodiments are provided.

Description

[Technical Field]

[0001] This case claims priority to U.S. Provisional Patent Application No. 63 / 140,190, filed on January 21, 2021, the disclosure of which is incorporated herein by reference in its entirety.

[0002] This case relates to a biosensor inserter configured to insert a biosensor, which may be a partial continuous analyte monitor. [Previous Technology]

[0003] Continuous glucose monitoring, such as using a continuous glucose monitor (CGM), has become a routine sensing operation, especially for sensing in diabetes care. By providing real-time glucose monitoring that provides glucose concentration over time, therapeutic actions such as insulin administration can be applied promptly, and blood glucose status can be better controlled.

[0004] During a CGM procedure, a biosensor of a transmitter and sensor assembly is inserted subcutaneously and operated continuously in an environment surrounded by tissue and interstitial fluid (ISF). The biosensor is inserted subcutaneously and provides a signal to the transmitter of the transmitter and sensor assembly, and this signal can indicate, for example, the patient's blood glucose level. These sensor measurements can be performed automatically multiple times intermittently throughout the day (e.g., every few minutes or other suitable time intervals).

[0005] The transmitter of the transmitter and sensor assembly is attached to the outer surface of the user's skin, such as the abdomen, 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 can be referred to as "insertion". The device used to perform this biosensor insertion can be referred to as a "biosensor inserter".

[0006] Biosensor inserters can be complex to design and expensive to manufacture. In addition, some biosensor inserters are discarded as medical waste after use. [Summary of the Invention]

[0007] In some embodiments, a biosensor inserter configured to insert a biosensor is provided. The biosensor inserter includes a pusher member including a receiver, a contact member translatable relative to the pusher member, and a needle container configured to receive a needle assembly including a needle set, the needle container being configured to be inserted into and removed from the receiver.

[0008] In a further embodiment, a biosensor inserter is provided. The biosensor inserter includes: a push member having a push element and a receiver; a cannula container including a sheath portion wherein the cannula container is received in the receiver; a contact member configured to extend and retract relative to the push member; a transmitter carrier configured to support a transmitter and a sensor assembly during insertion of the biosensor; a pivoting member configured to pivot on the transmitter carrier; the cannula assembly is supported by the pivoting member during insertion and retraction, and the cannula assembly is received in the sheath portion upon retraction.

[0009] In a further embodiment, a method is provided for inserting a biosensor into a user's body using a biosensor inserter. The method includes the steps of: providing a biosensor inserter comprising: a push member including a receiver; a cannula container inserted into the receiver, the cannula container including a sheath portion; a contact member translatable relative to the push member; and a cannula assembly including a cannula having a biosensor disposed therein; contacting the contact member with the user's skin; pushing the push member to insert the cannula and biosensor into the skin; continuing to push the push member to retract the cannula assembly into the sheath portion while maintaining the biosensor implanted; and removing the cannula container and the cannula assembly from the receiver.

[0010] Other features, appearances, and advantages of embodiments according to this application will become more apparent from the following detailed description, the claims, and the accompanying drawings, by way of illustrating a number of exemplary embodiments. Various embodiments according to this application can also be used in other and different applications, and certain details may be modified in various respects without departing from the scope of the claims and their equivalents. Therefore, this specification is to be considered illustrative in nature, rather than restrictive.

Implementation Method

[0022] A biosensor inserter is configured to implant (insert) a biosensor, consisting of a transmitter and a sensor assembly, into the skin of a person. In conventional biosensor inserters, a cannula assembly is used as part of the biosensor inserter, where the cannula facilitates the insertion of the biosensor into the human body. Once the biosensor insertion procedure has been performed, the cannula assembly and the cannula are retracted and are typically retained within the biosensor inserter. Because blood can contaminate the cannula and the biosensor inserter, conventional biosensor inserters are considered biohazardous and disposed of as medical waste, much like sharp instruments.

[0023] Embodiments of this invention are used to reduce the amount of medical waste generated during the use of these biosensor inserters. This is achieved by isolating the cannula assembly and the cannula from the rest of the biosensor inserter. In one or more embodiments described herein, a biosensor inserter is provided having components designed to be recyclable, while other components are removable and can be disposed of as medical waste. Therefore, a significant reduction in the amount of medical waste can increase the amount of recyclable material. According to some embodiments of this invention, after the insertion process is performed using the biosensor inserter, the cannula container carrying the cannula assembly is separated from the recyclable components by encapsulating the cannula assembly and the cannula in a sheath portion of a removable cannula container. Therefore, after removal, the cannula container and the cannula contained therein can be discarded as medical waste. The rest of the biosensor inserter can be recycled.

[0024] For example, in some embodiments, the biosensor inserter may include a pusher configured to be pushed by a user (the person receiving the biosensor or another person), a contact member configured to contact a person's skin, and a transmitter carrier that holds the transmitter and the biosensor assembly during the insertion process. When the user pushes the pusher, the transmitter carrier translates toward the user's skin, and during a first portion of the biosensor inserter's stroke, the cannula and biosensor are inserted therein. Continued pushing of the pusher and retraction of the cannula leaves the biosensor in the user's skin.

[0025] In one or more embodiments, the actuating component includes a receptacle-like cannula container in a receiver of the actuating component, configured to contain the cannula assembly in a sheath portion upon completion of the insertion process, wherein the cannula container and the cannula can be removed from the actuating component as a unit and disposed of as medical waste. The actuating component, the internal insertion / retraction mechanism, and the contact component can be considered recyclable material because they are not exposed to blood and do not contain any sharp parts. The largest volume of material is contained in the actuating component, the internal insertion / retraction mechanism, and the contact component, so only a small amount of material is considered medical waste, namely the cannula container and the cannula assembly. The cannula can also be referred to as an insertion portion.

[0026] In some embodiments, the skirt of the contact component configured to come into contact with human skin may be removable and, if it has been contaminated with blood, may be removed and disposed of as medical waste. Otherwise, it may be recycled.

[0027] Figures 1 through 3C illustrate various views of embodiments of the biosensor inserter 100, including configurations for a user to push to induce insertion of the biosensor 314 (as shown in Figures 3B-3C) and a translational (e.g., retractable) contact member 104 relative to the push member 102. The contact member 104 is configured to contact the user's skin during biosensor insertion. In the described embodiments, the push member 102 includes a receiver 107, which may be a pocket or other suitable opening. One type of mechanism 310 of the biosensor inserter 100 is illustrated (Figure 3A), operable to insert the cannula 212T of the cannula assembly 212 together with the biosensor 314 (Figures 3B-3C), and then retract the cannula assembly 212 and the cannula 212T.

[0028] Furthermore, the biosensor inserter 100 includes a cannula container 105 configured to retain the cannula assembly 212 after use, allowing for proper disposal. The cannula container 105 can provide a secondary function, namely, guiding proper alignment of the cannula assembly 212 during insertion. For example, the body 312B of the cannula assembly 212 (FIG. 3B) may have a shape similar to, but slightly smaller than, the internal shape of an internal channel formed in the sheath portion 205S of the cannula container 105 (e.g., a hollow interior 205I, see FIG. 2), such as the rectangular cross-sectional shape shown, allowing the body 312B of the cannula assembly 212 to slide within the hollow interior 205I, but not to rotate or tilt therein. The cannula container 105 is configured to be inserted into and removed from the receiver 107. Therefore, the cannula container 105 and the cannula assembly 212 can be removed from the receiver 107 of the pusher 102 and safely disposed of as medical waste after use.

[0029] Referring again to the cannula assembly 212 shown in Figures 2, 3B, and 3C, the body 312B of the cannula assembly 212 may include a wing 212W extending laterally therefrom. The wing 212W spans a slot 220 formed in the side of the sheath portion 205S of the cannula container and can be snapped through one or more retaining features 220R when the cannula assembly 212 is retracted. Thus, the slot 220 formed in the side of the sheath portion 205S is configured to receive the wing 212W of the cannula assembly 212. The one or more retaining features 220R may be configured to secure the cannula assembly 212 to the sheath portion 205S. Furthermore, the one or more retaining features 220R may include a narrow portion of the slot 220 formed in one or more sides of the sheath portion 205S, which is configured to receive the wing 212W of the cannula assembly 212. As shown in Figure 3A, the fork 316F of the pivot member 316 engages the wing 212W of the cannula assembly 212 to drive it and cause the biosensor to be inserted and subsequently retracted. In particular, the pivot member 316 includes a forked end comprising a fork 316F having a first fork and a second fork that can cross the sheath portion 205S of the cannula container 105, wherein each fork 316F may include a recess with an end opening configured to receive the wing 212W therein.

[0030] In some embodiments, the receiver 107 may be a pocket formed in the top of the push member 102. For example, as shown in FIG2, the receiver 107 may be formed in the top and / or side of the push member 102. As shown, the gripping portion 105G of the cannula container 105 is configured for gripping by a user's thumb and fingers. Any suitable surface feature 105F or feature that enhances the gripping of the cannula container 105 may be added to the side surface of the gripping portion 105G, for example by adding a raised portion (e.g., a raised rib) as shown. Alternatively, one or more recessed portions or other gripping features may be provided to enhance gripping. Furthermore, as shown in FIG2 and 3A, a retaining feature may be added to the cannula container 105, for example, to the gripping portion 105G. As shown, the retaining feature in this embodiment may include a hole 205H formed in a tab on the side of the gripping portion 105G. The hole 205H can be aligned with the guide 305P (Fig. 3A) formed on the main body of the push member 102.

[0031] Figure 2 shows the sheath portion 205S of the cannula container 105 in further detail. The cannula container 105 includes the sheath portion 205S extending from the gripping portion 105G. The sheath portion 205S includes a hollow interior 205I in which a portion of the cannula assembly 212 can be received. After the biosensor 314 is inserted, the cannula assembly 212 can be retracted into the hollow interior 205I of the sheath portion 205S by means of the pivoting member 316, similar to that shown in Figures 2 and 5.

[0032] As shown in the figure, the tip of the cannula 212T can be retracted so that it is completely inside the hollow interior 205I, so that the tip is covered and such contact with it is minimized. As shown in Figure 5, this is achieved by pivoting the pivoting member 316 as shown in Figure 3, which moves the wing 212W of the cannula assembly 212 upward through the retaining feature 220R in the slot 220 and effectively locks the wing 212W in the retaining area 220A (see Figure 2) of the cannula assembly 212 where the wing 212W is held, so that the cannula assembly 212 will not fall out of the sheath portion 205S.

[0033] When the cannula assembly 212 is captured within the hollow interior 205I, the user can fully squeeze the opposing side tabs 105T of the gripping portion 105G to move the orifice 205H past the guide 305P, and thus remove the cannula container 105 together with the cannula assembly 212. Therefore, material considered medical waste can be separated from the remaining recyclable parts. The cannula container 105, together with the cannula assembly 212, can then be disposed of as medical waste. Similarly, in a separate step, if contaminated, the skirt 104S can also be removed and disposed of as medical waste. The skirt 104S may be part of the contact member 104 and may slide across the upper portion 104U of the contact member 104, or otherwise removably attached to the upper portion 104U of the contact member 104.

[0034] Figures 3A and 4-7 illustrate the mechanism 310 of the biosensor inserter 100. In some embodiments, during the first portion (insertion portion) of the travel of the biosensor inserter 100, the pivoting of the pivoting member 316 of the cannula assembly 212 is restricted from contact and operably driven as the transmitter carrier 318 translates toward the user's skin, but is unlocked to allow pivoting once the biosensor 314 is implanted in the user's skin. When unlocked, the pivoting member 316 can pivot in the second portion of the travel of the biosensor inserter 100, which results in the retraction of the cannula assembly 212 (retraction portion of the travel) and inserts the biosensor 314 into the user's skin. Therefore, the pivoting member 316 does not pivot in the first portion of the travel, but rather in the second (retraction) portion of the travel. The transmitter carrier 318 is translatable relative to the contact member 104 and is configured to support the transmitter and sensor assembly 330 during insertion of the biosensor 314 (FIG. 3B). The transmitter carrier 318 may include an aperture 319 configured to receive the sheath portion 205S during insertion. Other suitable insertion and retraction mechanisms may be used.

[0035] Figures 3A and 4-7 further illustrate cross-sectional side views of a biosensor inserter 100 shown at various portions of the travel according to one or more embodiments provided in this application. The contact member 104 includes an upper portion 104U and a lower portion 104S. A lower end, which may be part of the skirt 104S, may contact the user's skin during insertion and retraction of the cannula assembly 212 to implant the biosensor 314. The contact member 104 also includes a latch 104L having a latching surface (lower latching surface) that allows the pivot member 116 to rotate (Figure 5) as movement via the latching end 316L of the pivot member 316 passes through this latching surface. The pivot member 316 may be configured to pivot on a transmitter carrier 318, for example, around a pivot 318P.

[0036] For example, the pivot 318P may include a laterally extending feature (e.g., a post) formed on the pivot member 316, which engages with holes or recesses formed in the first and second side supports of the transmitter carrier 318 (see FIG. 3A) to form a pivot axis. Thus, the pivot member 316 can pivot about the pivot axis and pivot on the pivot 318P formed by the transmitter carrier 318 and the pivot member 316.

[0037] The pivot position of the pivot 318P can be formed between the latch end 316L and the opposite end of the pivot member 316 containing the fork 316F. Other suitable lateral extension features can be used to form the pivot 318P, and other pivot mechanisms, such as detachable shafts, can be used.

[0038] The latch 104L may be formed as an opening in the sidewall of the contact member 104. The latch 104L may include a circumferentially arranged surface, the width of which may be wider than the latch end 316L of the pivot member 316. The pivot member 316 is restricted to rotate about the pivot 318P until the latch end 316L passes the latch 104L. As shown, the latch 104L is part of a vertically extending cutout, which may be closed at its lower end by a skirt 104S. Once past the latch 104L, the pivot member 316 can rotate.

[0039] As shown in Figures 3A-7, the actuating member 102 may include an actuating element 102P, which may be a rigid member extending downward from the lower side of the actuating member 102 (in the direction shown in Figure 3A) and includes a contact end that engages with the pivoting member 316. The actuating element 102P engages with the pivoting member 316 and rotates (pivots) and translates the transmitter carrier 318. The transmitter carrier 318 may be received within the contact member 104 and may have a transmitter and sensor assembly 330 coupled thereto. The transmitter and sensor assembly 330 includes transmitter electronics and radio, which can be used to transmit measured analyte values ​​and / or other data received from the implanted biosensor 314 to a reader, a smartphone running a suitable application, or other devices for processing and displaying analyte values ​​(including trends). The transmitter and sensor assembly 330 also includes a biosensor 314 coupled thereto, which has a read end that receives inside and is inserted with the aid of the cannula 212T, and after insertion, the cannula 212T is removed, and the biosensor 314 remains implanted in the human body.

[0040] In operation, the transmitter and sensor assembly 330 can be detachably coupled to the transmitter carrier 318. The transmitter and sensor assembly 330 may include an adhesive layer to adhere the transmitter and sensor assembly 330 to the user's skin when the cannula assembly 212 is retracted. Any suitable mechanism that allows the transmitter and sensor assembly 330 to be separated from the transmitter carrier 318 can be used, such as pressure-sensitive adhesive, slight interference fit, low release force retention mechanism, etc.

[0041] In some embodiments, the pushing component 102, the contact component 104, the pivoting component 316, and / or the conveyor carrier 318 may be formed of biodegradable and / or recyclable materials (e.g., recyclable plastics, biodegradable paper products, bamboo, etc.). In particular, in some embodiments, recyclable plastics may be used for the above-mentioned components, including but not limited to polyethylene terephthalate (PET), high-density polyethylene (HDPE), low-density polyethylene (LDPE), polyvinyl chloride, polypropylene, polystyrene, etc.

[0042] More specifically, the transmitter carrier 318 is axially translatable relative to the contact member 104 and is configured to support the transmitter and sensor assembly 330 during insertion of the biosensor 314. In particular, the transmitter and sensor assembly 330 may include transmitter electronics 336, a power supply (not shown), and a biosensor assembly including the biosensor 314.

[0043] The transmitter and sensor assembly 330 may include transmitter electronics 336 (FIG. 3B), which may include an analog front end for biasing the biosensor 314 and for sensing the current through the biosensor 314, such as one or more operational amplifiers, current sensing circuitry, processing circuitry, such as an analog-to-digital converter for digitizing the current signal, memory for storing the digitized current signal, a controller for possibly calculating the analyte concentration value based on the measured current signal, such as a microprocessor, microcontroller, etc., and transmitter circuitry for transmitting the analyte concentration value to an external device (e.g., a smartphone, or other suitable external readout device configured to store and / or display the analyte concentration).

[0044] In some embodiments, a biosensor 314 used within the transmitter and sensor assembly 330 may include two electrodes, and a bias voltage may be applied to this pair of electrodes. In this case, current can be measured by the biosensor 314. In other embodiments, the biosensor 314 may include three electrodes, such as a working electrode, a reverse electrode, and a reference electrode. In this case, for example, a bias voltage may be applied between the working electrode and the reference electrode, and current through the working electrode can be measured. The biosensor 314 may include an active region comprising one or more chemical substances that undergo an analyte-enzyme reaction with the products they detect. The enzyme may be immobilized on one or more electrodes to provide a reaction with the analyte (e.g., a redox reaction) and generate a current at the electrode. Example chemicals include glucose oxidase, glucose dehydrogenase, etc., for measuring glucose as an analyte. In some embodiments, a mediator, such as ferricyanide or ferrocene, may be used in the active region. Generally, any analyte, such as glucose, cholesterol, lactic acid, uric acid, alcohol, etc., can be detected and / or monitored by a suitable biosensor. In this case, an analyte is defined as a component, substance, chemical substance, or chemical composition that is measurable during the analysis.

[0045] An example of the biosensor 314 may be any suitable implantable sensor that can be implanted in the user’s skin, such as the linear sensor shown in Figures 3B-3C, which is capable of receiving inside the side groove 332 formed longitudinally in the cannula 212T of the cannula assembly 212 and is capable of sensing the concentration of the analyte in the tissue fluid under the skin.

[0046] The cannula 212T of the cannula assembly 212 can be made of, for example, a metal such as stainless steel or a non-metal such as plastic. Other suitable materials may also be used. In some embodiments, the cannula 212T may have a longitudinally formed side groove 332, which is formed by, but is not limited to, a circular C-shaped channel tube, a circular U-shaped channel tube, a stamped sheet metal part folded into a U-shaped profile cross section, a molded / cast metal part having a U-shaped channel profile cross section, or a solid metal cylinder having an etched or grounded channel forming a U-shaped cross section. Other cannula shapes that allow for insertion and retraction can be used while keeping the biosensor 314 implanted.

[0047] The body 312B of the cannula assembly 212 may be formed of a suitable plastic, such as, but not limited to, acrylonitrile butadiene styrene (ABS), polycarbonate, nylon, acetal, polyphthalamide (PPA), polyurethane, polyether ether ether, poly(PEEK), polypropylene, high-density polyethylene (HDPE), and low-density polyethylene (LDPE). Other suitable rigid materials may also be used.

[0048] As shown in Figures 3B and 3C, the biosensor 314 is received in the side groove 332 of the cannula 212T, extends along the length of the cannula 212T, transitions into a channel 334 formed in the threaded portion 331, and then laterally passes through the channel 334 to connect to the transmitter electronics 336, such as a circuit board, or other similar electronic components, including, coupled to, or configured to couple to other electronic components of the transmitter and sensor assembly 330. Therefore, when the cannula 212T is inserted and withdrawn from the user's skin, the biosensor 314 can remain in place by being removed from the channel 334 and the side groove 332.

[0049] In operation, the cannula assembly 212 can be driven by contacting the fork 316F of the pivot member 316 during the insertion stroke to insert the biosensor 314 into the user's skin. Specifically, the cannula assembly 212 can be driven by the wing 212W of the body 312B, which is received in a groove at the open end formed in the fork 316F of the pivot member 316. Furthermore, the body 312B may include a rectangular portion received within a similar rectangular portion of the hollow interior 205I. As described above, the rectangular portion can engage and provide anti-rotational support.

[0050] As shown in FIG. 3A, the contact member 104 may be configured to be concentric with the push member 102 and may extend and retract therewith. In some embodiments, the contact member 104 may include a first alignment feature, such as a vertically extending groove or notch, and the transmitter carrier 318 may include a second alignment feature, such as a vertically extending finger-like tab intersecting the first alignment feature. These alignment features may keep the contact member 104 and the transmitter carrier 318 rotationally aligned to prevent rotation between them, for example, during the insertion and retraction portions of the stroke. The push member 102 and the contact member 104 may be elliptical or rectangular in cross-section as shown, or optionally circular, elliptical, or any other suitable shape. In some embodiments, the push member 102 and the contact member 104 may not be concentric.

[0051] The operation of the biosensor inserter 100 will now be described with reference to Figures 4-7, which show a cross-sectional side view of the sensor inserter 100 according to an embodiment provided in this invention, which operatively inserts the biosensor 314 during various portions of the insertion method's stroke. Furthermore, Figure 8 illustrates a flowchart of a method 800 that uses the biosensor inserter 100 according to an embodiment provided in this invention to insert the biosensor 314.

[0052] As the insertion method 300 of FIG8 begins, a needle cap (not shown) may be removed from the threaded portion 331 of the cannula assembly 212 of the biosensor inserter 100. The biosensor inserter 100 is positioned to contact the skin around the user’s desired insertion site, such as on the upper arm, abdomen, or other suitable location.

[0053] To initiate insertion, the user applies a force 108 to the push member 102, causing the push member 102 to translate relative to the contact member 104 and move toward the insertion site. The movement of the push member 102 on the contact member 104 causes the push element 102P to contact the pivot member 316, which causes the transmitter carrier 318 and the pivot member 316 to translate and move toward the insertion site, wherein the latch end 316L moves linearly along the wall relative to the latch 104L.

[0054] During the first portion of the stroke of method 800, pivoting of the pivoting member 316 is prevented by contact between the latch end 316L and the wall of the contact member 104. As a result, the transmitter carrier 318 and the coupled transmitter and sensor assembly 330 translate toward the insertion site.

[0055] As shown in FIG. 4, the transmitter carrier 114 and the transmitter and sensor assembly 330 continue to move toward the insertion site, and the cannula 212T contacts and enters the insertion site into the skin, with the bottom surface of the transmitter and sensor assembly 330 contacting the skin surrounding the insertion site. In some embodiments, the bottom surface of the transmitter and sensor assembly 330 may adhere (e.g., by means of an adhesive material) to the user's skin surrounding the insertion site. The cannula 212T and biosensor 314 enter the insertion site, where the biosensor 314 may contact the interstitial fluid in the subcutaneous region. For example, the biosensor 314 may be placed 4 mm to 6 mm into the skin, although other depths may be used.

[0056] As shown in FIG5, after the insertion of the biosensor 314 (including the attachment of the transmitter and sensor assembly 330 to the skin around the insertion site), the actuating member 102 continues to move relative to the contact member 104 during the second portion of the stroke. As the latching end 316L of the pivoting member 316 moves past the latch 104L at the beginning of the second portion of the stroke, the pivoting member 316 is allowed to pivot via the actuating element 102P, rotating about the pivot 318P below the latch 104L and entering the incision portion 338. This pivoting causes the cannula assembly 212 to retract during the second portion of the stroke.

[0057] During retraction, the pivoting member 316 pivots on the transmitter carrier 318 due to the force 108 applied to it by the actuating element 102P. As this occurs, the cannula assembly 212 retracts from the insertion site and moves away from the transmitter and sensor assembly 330 adhered to the user. As the actuating element 102 continues to move relative to the contact member 104 toward the insertion site, the actuating element 102P continues to press against the pivoting member 316. Finally, as shown in FIG. 5, the pivoting member 316 fully pivots to completely remove the cannula assembly 212 from the user's skin, leaving the implanted biosensor 314 therein. With further actuation of the actuating element 102, the cannula assembly 212 retracts along the slot 220 and passes through the retaining feature 220R. Furthermore, the cannula assembly 212 retracts into the sheath portion 205S of the cannula container 105 and is thus securely retained.

[0058] The biosensor inserter 100 can then be removed, leaving the transmitter and sensor assembly 330 in place, with the bottom surface of the transmitter and sensor assembly 330 adhering to the user's skin at the insertion site, and the biosensor 314 in contact with the user's interstitial fluid.

[0059] Before or after removing the biosensor inserter 100, the cannula container 105, which contains and holds the cannula assembly 212, may be removed, as shown in FIG. 6. The cannula assembly 212 is secured in the cannula container 105 and may be disposed of as medical waste.

[0060] In some embodiments, the actuating component 102, the contact component 104, the pivoting component 316, and the transmitter carrier 318 are formed of recyclable or biodegradable materials, and these components can be recycled or composted. Therefore, it should be recognized that the biosensor inserter 100 of this invention significantly reduces the amount of medical waste and increases the amount of recyclable or biodegradable materials.

[0061] Figure 7 shows an exploded view of the various components of the biosensor inserter 100.

[0062] Referring now to FIG8, an embodiment of a method 800 for inserting a biosensor (e.g., biosensor 314) into a user's body using a biosensor inserter (e.g., biosensor inserter 100) is described. Method 800 includes, in block 802, providing a biosensor inserter (e.g., biosensor inserter 100) comprising: a push member (e.g., push member 102) including a receiver (e.g., receiver 107), a cannula container (e.g., cannula container 105) inserted into the receiver, the cannula container including a sheath portion (e.g., sheath portion 205S), and a contact member (e.g., contact member 104) translatable relative to the push member; and a cannula assembly (e.g., cannula assembly 212) including a set of needles (e.g., cannula 212T).

[0063] Method 800 further includes, in block 804, bringing a contact member (e.g., contact member 104) into contact with the user's skin, and in block 806, pushing a pushing member (e.g., pushing member 102) to insert a cannula (e.g., cannula 212T) and to bring a biosensor (e.g., biosensor 314) into the skin. The pushing (force 108) causes a transmitter carrier (e.g., transmitter carrier 318) to translate relative to the contact member.

[0064] Furthermore, method 800 includes, in block 808, continuing to push a pushing member (e.g., pushing member 102) to retract the cannula assembly (e.g., cannula assembly 212) into the sheath portion (e.g., sheath portion 205S) while maintaining the biosensor (e.g., biosensor 314) implanted. Finally, method 800 includes, in block 810, removing the cannula container (e.g., cannula container 105) and the cannula assembly (e.g., cannula assembly 212) from the receiver (e.g., receiver 107). After removal, if contaminated with blood, the cannula container 105 and the cannula assembly 212 can be disposed of as medical waste along with the skirt 104S. The remaining parts of the biosensor inserter 100 can be recycled.

[0065] The foregoing description discloses only exemplary embodiments. Modifications to the above-described apparatus and methods that fall within the scope of this case will be readily apparent to those skilled in the art. [Simplified Explanation of the Diagram]

[0011] The accompanying drawings should be considered illustrative, not restrictive. The drawings are not necessarily drawn to scale. The same numbers are used throughout the drawings to represent the same elements.

[0012] FIG1 is a perspective view of a biosensor inserter including a removable cannula container according to one or more embodiments provided in this case.

[0013] FIG2 is a partially exploded side view of a biosensor inserter according to one or more embodiments provided in this case, the biosensor inserter including a removable cannula container for retaining a cannula assembly.

[0014] FIG3A is a cross-sectional perspective side view of a biosensor inserter shown in an extended configuration used when inserting a cannula and a biosensor according to one or more embodiments provided in this case.

[0015] FIG3B is a perspective side view of a cannula assembly including a cannula and a biosensor according to one or more embodiments provided in this case.

[0016] FIG3C is an enlarged cross-sectional partial side view of a cannula assembly according to one or more embodiments provided in this case, showing the biosensor moving into the side groove of the cannula.

[0017] Figure 4 is a cross-sectional side view of a biosensor inserter according to one or more embodiments provided in this case, showing it in a first extended position, wherein the cannula and the biosensor will be inserted into a person's skin.

[0018] FIG5 is a cross-sectional side view of a biosensor inserter according to one or more embodiments provided in this case, showing it in a retracted position, wherein the cannula assembly is coupled to a removable cannula container.

[0019] FIG6 is a cross-sectional side view of a biosensor inserter according to one or more embodiments provided in this case, wherein the cannula and cannula container are removed from the remainder of the biosensor inserter.

[0020] FIG7 is an exploded cross-sectional side view of a biosensor inserter according to one or more embodiments provided in this case, wherein the cannula and cannula container are removed from the remainder of the biosensor inserter.

[0021] Figure 8 illustrates a flowchart of a method for inserting a biosensor into a user's body using a biosensor inserter according to an embodiment provided in this case. [Biomaterial Storage]

[0067] Domestic Storage Information (Please note in order of storage institution, date, and number) None

[0068] Overseas Deposit Information (Please note in the order of deposit country, institution, date, and number) None

Claims

1. A biosensor inserter configured to insert a biosensor, comprising: A pushing component includes a receiver; a contact component is translatable relative to the pushing component; And a needle container configured to receive a needle assembly including a set of needles, the needle container being configured to be inserted into and removed from the receiver.

2. The biosensor inserter as claimed in claim 1, wherein the receiver includes a pouch formed within a top of the push member.

3. The biosensor inserter as claimed in claim 1, wherein the cannula container includes a gripping portion and a sheath portion, wherein, After the biosensor is inserted, the cannula assembly can retract into the sheath portion.

4. The biosensor inserter as claimed in claim 3, wherein the sheath portion includes one or more retaining features configured to secure the cannula assembly to the sheath portion.

5. The biosensor inserter as claimed in claim 4, wherein the one or more retaining features include a narrow portion of a slot formed on one side of the sheath portion, the sheath portion being configured to receive a wing of the cannula assembly.

6. The biosensor inserter as claimed in claim 1, wherein the cannula container, which includes the cannula assembly, is removable from the receiver of the actuating member.

7. The biosensor inserter as claimed in claim 1, comprising a transmitter carrier that is translatable relative to the contact member and configured to support a transmitter and a sensor assembly during insertion of the biosensor.

8. The biosensor inserter as claimed in claim 7, wherein the transmitter carrier includes an opening configured to receive a sheath portion during insertion of the biosensor.

9. The biosensor inserter as claimed in claim 7, comprising a pivoting member configured to pivot on the transmitter carrier, the pivoting member including a latching end.

10. The biosensor inserter as claimed in claim 9, wherein the pivoting member includes a forked end comprising a first fork and a second fork extending across a sheath portion of the cannula container.

11. The biosensor inserter as claimed in claim 10, wherein each of the first fork and the second fork includes a groove formed therein at an open end and is configured to receive a wing of the cannula assembly therein.

12. The biosensor inserter as claimed in claim 1, wherein the actuating member further includes an actuating element configured to engage a pivoting member.

13. The biosensor inserter as claimed in claim 1, wherein the cannula container includes a sheath portion including slots formed in the side of the sheath portion, the slots being configured to receive a wing of the cannula assembly.

14. A biosensor inserter, comprising: A pusher having a push element and a receiver; a cannula container including a sheath portion wherein the cannula container is received in the receiver; a contact member configured to extend and retract relative to the pusher; a transmitter carrier configured to support a transmitter and sensor assembly during insertion of a biosensor; a pivot member configured to pivot on the transmitter carrier; and a cannula assembly supported by the pivot member during insertion and retraction, the cannula assembly being received in the sheath portion upon retraction.

15. A method of inserting a biosensor into a user's body using a biosensor inserter, comprising the following steps: providing the biosensor inserter, including: A pusher includes a receiver; a cannula container inserted into the receiver, the cannula container including a sheath portion; a contact member translatable relative to the pusher; and a cannula assembly including a cannula having the biosensor therein; bringing the contact member into contact with the user's skin; pushing the pusher to insert the cannula and the biosensor into the skin; continuing to push the pusher to retract the cannula assembly into the sheath portion while keeping the biosensor implanted; and removing the cannula container and cannula assembly from the receiver.

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