Biological sensor inserter and method 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, the 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

[0001] Cross-reference to related applications

[0002] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 140,190, filed January 21, 2021, the disclosure of which is incorporated herein by reference in its entirety for all purposes. Technical Field

[0003] This disclosure relates to a biosensor inserter configured to insert a biosensor, which may be part of continuous analyte monitoring. Background Technology

[0004] Continuous glucose monitoring (such as with a continuous glucose monitor (CGM)) has become a routine sensing procedure, especially for sensing in diabetes care. By providing real-time glucose monitoring that provides glucose concentration over time, therapeutic actions (such as insulin infusion) can be applied in a timely manner, and glycemic status can be better controlled.

[0005] During a CGM procedure, a biosensor from the transmitter and sensor assembly is inserted subcutaneously and operates continuously in an environment surrounded by tissue and interstitial fluid (ISF). The biosensor, inserted under the skin, provides a signal to the transmitter of the transmitter and sensor assembly, and this signal can, for example, indicate the patient's blood glucose level. These sensor measurements can be performed intermittently and automatically multiple times throughout the day (e.g., every few minutes or other suitable intervals).

[0006] The transmitter, consisting of a transmitter and a sensor assembly, is adhered to the outer surface of the user's skin, such as on the abdomen, the back of the upper arm, or another suitable location, while the biosensor is inserted through the skin to contact the ISF (intrinsic sensor tissue). 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."

[0007] Biosensor inserters can be complex to design and expensive to manufacture. Furthermore, some biosensor inserters are discarded as medical waste after use. Summary of the Invention

[0008] In some embodiments, a biosensor inserter configured to insert a biosensor is provided. The biosensor inserter includes: a push member including a receiver, a contact member translatable relative to the push member, and a cannula retainer configured to receive a cannula assembly including a cannula needle, the cannula retainer being insertable into and removable from the receiver.

[0009] In a further embodiment, a biosensor inserter is provided. The biosensor inserter includes: a push member having a push element and a receiver; a needle retainer including a sheath portion, wherein the needle retainer 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 pivot member configured to pivot on the transmitter carrier; and a needle assembly supported by the pivot member during insertion and retraction, the needle assembly being receptacleable in the sheath portion upon retraction.

[0010] In a further embodiment, a method is provided for inserting a biosensor into a user using a biosensor inserter. The method includes: providing the biosensor inserter, the biosensor inserter comprising: a push member including a receiver; a cannula retainer inserted into the receiver, the cannula retainer including a sheath portion; a contact member translatable relative to the push member; and a cannula assembly including a cannula having a biosensor therein; contacting the push member with the user's skin; pushing the push member to cause the cannula and the biosensor to be inserted into the skin; continuing to push the push member to retract the cannula assembly into the sheath portion while implanting the biosensor; and removing the cannula retainer and the cannula assembly from the receiver.

[0011] Other features, aspects, and advantages of embodiments according to this disclosure will become more apparent from the following detailed description, claims, and drawings, by illustrating several exemplary embodiments. Various embodiments according to this disclosure may also be applicable to other and different applications, and several details thereof 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 and not restrictive. Attached Figure Description

[0012] The accompanying drawings are intended to be illustrative rather than restrictive. The drawings are not necessarily drawn to scale. Throughout the drawings, the same reference numerals are used to denote the same elements.

[0013] Figure 1 This is a side perspective view of a biosensor inserter including a removable cannula retainer, according to one or more embodiments provided herein.

[0014] Figure 2 This is a partially exploded side view of a biosensor inserter including a removable cannula retainer assembly, according to one or more embodiments provided herein.

[0015] Figure 3AThis is a cross-sectional perspective side view of a biosensor inserter shown in an extended configuration, used in the insertion of a cannula and a biosensor according to one or more embodiments provided herein.

[0016] Figure 3B This is a perspective side view of a cannula assembly including a cannula and a biosensor according to one or more embodiments provided herein.

[0017] Figure 3C This is an enlarged cross-sectional partial side view of a cannula assembly according to one or more embodiments provided herein, showing a biosensor transitioning into a side groove of the cannula.

[0018] Figure 4 This is a cross-sectional side view of a biosensor inserter shown in a first extended position according to one or more embodiments provided herein, in which the cannula and biosensor will be inserted into a person's skin.

[0019] Figure 5 This is a cross-sectional side view of a biosensor inserter shown in a retracted position according to one or more embodiments provided herein, wherein the cannula assembly is coupled to a removable cannula retainer.

[0020] Figure 6 This is a cross-sectional side view of a biosensor inserter according to one or more embodiments provided herein, showing the cannula and cannula retainer being removed from the remainder of the biosensor inserter.

[0021] Figure 7 This is an exploded cross-sectional side view of a biosensor inserter according to one or more embodiments provided herein, showing the cannula and cannula retainer being removed from the remainder of the biosensor inserter.

[0022] Figure 8 A flowchart illustrating a method for inserting a biosensor into a user using a biosensor inserter according to embodiments provided herein is shown. Detailed Implementation

[0023] A biosensor inserter is configured to implant (insert) a biosensor, consisting of a transmitter and a sensor assembly, into a person's skin. In conventional biosensor inserters, a cannula assembly is used as part of the inserter, with its cannula facilitating the insertion of the biosensor into the body. Once the biosensor insertion procedure has been performed, the cannula assembly and cannula are retracted and typically remain inside the biosensor inserter. Because blood can contaminate the cannula and biosensor inserter, conventional biosensor inserters are considered biohazardous and disposed of as medical waste, like sharps.

[0024] Embodiments of this disclosure aim 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 remaining portions of the biosensor inserter. In one or more embodiments described herein, a biosensor inserter is provided having parts designed to be recyclable, while other parts are removable and can be disposed of as medical waste. Therefore, the amount of medical waste is significantly reduced, and the amount of recyclable material is increased. According to some embodiments of this disclosure, after the insertion process is performed using the biosensor inserter, the cannula holder carrying the cannula assembly is separated from the recyclable parts by enclosing the cannula assembly and the cannula within a sheath of a removable cannula holder. Therefore, after removal, the cannula holder and the cannula contained therein can be discarded as medical waste. The remaining portions of the biosensor inserter are recyclable.

[0025] For example, in some embodiments, the biosensor inserter may include a push member configured to be pushed by a user (the person receiving the biosensor or another person), a contact member configured to contact the person's skin, and a transmitter carrier that holds the transmitter and biosensor assembly during insertion of the biosensor. As the user pushes the push member, the transmitter carrier translates toward the user's skin, inserting the cannula and biosensor therein during a first portion of the biosensor inserter's stroke. Continued pushing of the push member causes the cannula to retract, thereby implanting the biosensor into the user's skin.

[0026] In one or more embodiments, the actuating member includes a cannula retainer configurable within a receiver of the actuating member and configured to receive the cannula assembly in a sheath portion after insertion, wherein the cannula retainer and cannula can be removed from the actuating member as a unit and disposed of as medical waste. The actuating member, internal insertion / retraction mechanism, and contact member can be considered recyclable materials because they are not exposed to blood and do not contain any sharps. The largest volume of material is contained in the actuating member, internal insertion / retraction mechanism, and contact member; therefore, only a small amount of material is considered medical waste, namely the cannula retainer and cannula assembly. The cannula may also be referred to as the insertion portion.

[0027] In some embodiments, the skirt of a contact member configured to come into contact with human skin may be removable and, if it has become contaminated with blood, may be removed and disposed of as medical waste. Otherwise, it may be recycled.

[0028] Figures 1 to 3C Various views of an embodiment of a biosensor inserter 100 are shown, the biosensor inserter including: configured to be pushed by a user to cause a biosensor 314 ( Figure 3B-3C The biosensor inserter 100 (as shown in the illustration) includes an insertion push member 102 and a contact member 104 that is translatable (e.g., retractable) relative to the push member 102. The contact member 104 is configured to contact the user's skin during the biosensor insertion process. In the depicted embodiment, the push member 102 includes a receiver 107, which may be a recess or other suitable opening. One type of mechanism 310 of the biosensor inserter 100 is shown. Figure 3A It is operable to insert the cannula 212T of the cannula assembly 212 together with the biosensor 314. Figure 3B-3C Then retract the cannula assembly 212 and the cannula 212T.

[0029] Furthermore, the biosensor inserter 100 includes a cannula retainer 105 configured to hold the cannula assembly 212 after use so that it can be properly disposed of. The cannula retainer 105 can provide assistance in guiding the proper alignment of the cannula assembly 212 during insertion. For example, the body 312B of the cannula assembly 212 ( Figure 3B It may have a shape such as the rectangular cross-sectional shape shown, which is similar to but slightly smaller than the internal channel (e.g., hollow interior 205I-) formed in the sheath portion 205S of the cannula retainer 105. Figure 2 The internal shape of the cannula assembly 212 allows the body 312B to slide within the hollow interior 205I, but not to rotate or tilt within it. The cannula retainer 105 is configured to be inserted into and removed from the receiver 107. Therefore, the cannula retainer 105 and the cannula assembly 212 can be removed from the receiver 107 of the push member 102 and safely disposed of as medical waste after use.

[0030] Refer again Figure 2 and Figure 3B and Figure 3C The cannula assembly 212 shown may include a body 312B of the body 212 that includes laterally extending wings 212W. The wings 212W ride in slots 220 formed in the side of the sheath portion 205S of the cannula retainer and can engage with one or more retaining features 220R when the cannula assembly 212 is retracted. Therefore, the slots 220 formed in the side of the sheath portion 205S are configured to receive the wings 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. Further, the one or more retaining features 220R may include a narrowed portion of the slots 220 formed in one or more side of the sheath portion 205S, the slots being configured to receive the wings 212W of the cannula assembly 212. Figure 3AAs shown, the fork 316F of the pivot member 316 engages the wing 212W of the cannula assembly 212 to drive it and induce biosensor insertion and subsequent retraction. Specifically, the pivot member 316 includes a forked end comprising a fork 316F having a first fork and a second fork that can span the sheath portion 205S of the cannula holder 105, wherein each fork 316F may include a groove configured to receive an end opening of the wing 212W therein.

[0031] In some embodiments, the receiver 107 may be a recess formed in the top of the push member 102. For example, such as Figure 2 As shown, the receiver 107 may be formed in the top and / or one or more sides of the push member 102. As shown, the grip portion 105G of the cannula holder 105 is configured for gripping by the user's thumb and fingers. Any suitable surface feature 105F or feature that enhances the grip of the cannula holder 105 may be added to the side surface of the grip portion 105G, such as by adding protrusions (e.g., raised ribs) as shown. Optionally, one or more recesses or other grip features may be provided to enhance the grip. Additionally, as... Figure 2 and Figure 3A As shown, retaining features can be added to the cannula holder 105, such as a gripping portion 105G. In this embodiment, the retaining feature may include a hole 205H formed in a protrusion on the side of the gripping portion 105G as shown. The hole 205H can connect with a guide portion 305P formed on the main body of the push member 102. Figure 3A Registration.

[0032] Figure 2 The sheath portion 205S of the cannula holder 105 is shown in further detail. The cannula holder 105 includes the sheath portion 205S extending from the gripper 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 insertion of the biosensor 314, the cannula assembly 212 can be retracted into the hollow interior 205I of the sheath portion 205S via the pivot member 316, similar to... Figure 2 and Figure 5 As shown in the image.

[0033] As shown in the figure, the tip of the cannula 212T can be retracted so that it is completely inside the hollow interior 205I, thereby securing the tip and minimizing contact with it. This is achieved through... Figure 5 This is achieved by the pivoting of the pivot member 316 shown, which moves the wing 212W of the cannula assembly 212 upward in the slot 220 past the retaining feature 220R and effectively locks the wing 212W into the retaining region 220A of the cannula assembly 212 (see...). Figure 2 In this part, the wing 212W is securely held so that the cannula assembly 212 does not fall out of the sheath 205S.

[0034] When the cannula assembly 212 is captured within the hollow interior 205I, the user can fully squeeze the opposing side protrusions 105T of the gripping portion 105G to move the orifice 205H past the guide portion 305P, and thus remove the cannula holder 105 together with the cannula assembly 212. Therefore, material considered medical waste can be separated from the remaining recyclable portion. The cannula holder 105, together with the cannula assembly 212, can then be disposed of as medical waste. Similarly, in a separate step, the skirt 104S (if contaminated) can also be removed and disposed of as medical waste. The skirt 104S may be part of the contact member 104 and may slide over or otherwise detachably fasten to the upper portion 104U of the contact member 104.

[0035] Figure 3A and Figure 4-7 The mechanism 310 of the biosensor inserter 100 is shown. In some embodiments, during a first portion (insertion portion) of the travel of the biosensor inserter 100, the pivot member 316 of the cannula assembly 212 is restricted from contact and operably driven to pivot as the transmitter carrier 318 translates toward the user's skin, but pivoting is permitted once the biosensor 314 is implanted into the user's skin and unlocked. Once unlocked, the pivot member 316 can pivot in a second portion of the travel of the biosensor inserter 100, which causes the cannula assembly 212 to retract (retraction portion of the travel) and allows the biosensor 314 to be inserted into the user's skin. Therefore, the pivot member 316 does not pivot in the first portion of the travel, but in the second (retraction) portion of the travel. The transmitter carrier 318 is translatable relative to the contact member 104 and configured to support the transmitter and sensor assembly 330 during insertion of the biosensor 314. Figure 3B The transmitter carrier 318 may include an aperture 319 configured to receive the sheath portion 205S during insertion. Other suitable mechanisms for insertion and retraction may be used.

[0036] Figure 3A and Figure 4-7A cross-sectional side view of the biosensor inserter 100, shown at various portions of the travel according to one or more embodiments provided herein, is further illustrated. The contact member 104 includes an upper portion 104U and a skirt 104S at a lower end. The lower end of the portion that may be 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 further includes a latch 104L having a latching surface (lower latching surface) that, once passed via movement via the latching end 316L of the pivot member 316, will allow the pivot member 116 to rotate (…). Figure 5 The pivot member 316 may be configured to pivot on the transmitter carrier 318 (such as about pivot 318P).

[0037] For example, pivot 318P may include a laterally extending feature (e.g., a column) formed on pivot member 316, which, together with a first side support and a second side support formed on transmitter carrier 318 (see... Figure 3A The holes or recesses in the ) fit together to form a pivot axis. Therefore, 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.

[0038] The pivot position of pivot 318P can be formed between the latch end 316L and the opposite end of pivot member 316 containing fork 316F. Other suitable lateral extension features can be used to form pivot 318P, and other pivot mechanisms, such as detachable axles, can be used.

[0039] 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. Rotation of the pivot member 316 about the pivot 318P is restricted until the latch end 316L passes through the latch 104L. As shown, the latch 104L is a portion with a vertically extending cut that may be closed at its lower end by a skirt 104S. Once past the latch 104L, the pivot member 316 can rotate.

[0040] like Figure 3A-7 As shown, the pushing member 102 may include a pushing element 102P, which may extend downward from the lower side of the pushing member 102 (e.g., Figure 3AThe transmitter carrier 318 is a rigid member (oriented in the middle) and includes a contact end that engages with the pivot member 316. The push element 102P engages with the pivot member 316 and causes its rotation (pivot) and translation of the transmitter carrier 318. The transmitter carrier 318 can be received within the contact member 104 and can have a transmitter and sensor assembly 330 coupled thereto. The transmitter and sensor assembly 330 includes transmitter electronics and radio, a smartphone executing a suitable application, or other devices for processing and displaying the analyte values ​​(including trends) received from the implanted biosensor 314 to a reader. The transmitter and sensor assembly 330 further includes a biosensor 314 coupled thereto, which has a reading end received within a cannula 212T and is inserted by means of the cannula 212T, after which the cannula 212T is removed and the biosensor 314 remains implanted in the human body.

[0041] 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.

[0042] In some embodiments, the actuating member 102, the contact member 104, the pivot member 316, and / or the transmitter 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 components listed above, including but not limited to polyethylene terephthalate (PET), high-density polyethylene (HDPE), low-density polyethylene (LDPE), polyvinyl chloride, polypropylene, polystyrene, etc.

[0043] More specifically, the transmitter carrier 318 is axially translatable relative to the contact member 104 and 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.

[0044] The transmitter and sensor assembly 330 may include transmitter electronics 336. Figure 3BThe transmitter electronics may include an analog front end for biasing the biosensor 314 and for sensing the current through the biosensor 314, such as an operational amplifier or amplifier; a current sensing circuit system; a processing circuit system (such as an analog-to-digital converter for digitizing the current signal, a memory for storing the digitized current signal, a controller for calculating the analyte concentration value based on the measured current signal, such as a microprocessor, microcontroller, etc.); and a transmitter circuit system for transmitting the analyte concentration value to an external device (e.g., a smartphone or another suitable external reader device configured to store and / or display the analyte concentration).

[0045] 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 the pair of electrodes. In such cases, current can be measured by the biosensor 314. In other embodiments, the biosensor 314 may include three electrodes, such as a working electrode, a pair of electrodes, and a reference electrode. In such cases, for example, a bias voltage may be applied between the working electrode and the reference electrode, and current can be measured by the working electrode. The biosensor 314 may include an active region comprising one or more chemical substances that react with the analyte-enzyme reaction of the product it detects. Enzymes may be immobilized on one or more electrodes to react with the analyte and generate current at the electrode. Exemplary chemical substances include glucose oxidase, glucose dehydrogenase, etc., for measuring glucose as an analyte. In some embodiments, mediators such as ferricyanide or ferrocene may be employed in the active region. Generally, any analyte that can be detected and / or monitored by a suitable biosensor and that presents a suitable chemical reaction can be measured, such as glucose, cholesterol, lactic acid, uric acid, alcohol, etc. An analyte is defined herein as a component, substance, chemical species, or chemical composition that can be measured by an analytical procedure.

[0046] Examples of biosensors 314 can be any suitable implantable sensor that can be implanted in the user's skin, such as Figure 3B-3C The linear sensor shown can be received inside the side groove 332 formed longitudinally in the cannula 212T of the cannula assembly 212 and can sense the concentration of analytes in the interstitial fluid under the skin.

[0047] For example, the cannula 212T of the cannula assembly 212 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 cannula 212T may have longitudinally formed side grooves 332, which are formed from (but not limited to) a circular C-shaped channel tube, a circular U-shaped channel tube, a stamped metal sheet part folded into a U-shaped cross-section, a molded / cast metal part with a U-shaped channel cross-section, or a solid metal cylinder having etched or ground channels that result in a U-shaped cross-section. Other cannula shapes that allow for insertion and retraction may be used while implanting the biosensor 314.

[0048] The body 312B of the cannula assembly 212 can be formed of a suitable plastic, such as, but not limited to, acrylonitrile butadiene styrene (ABS), polycarbonate, nylon, acetal, polyphthalamide (PPA), polysulfone, polyethersulfone, polyether ether ketone (PEEK), polypropylene, high-density polyethylene (HDPE), and low-density polyethylene (LDPE). Other suitable rigid materials may also be used.

[0049] like Figure 3B and Figure 3C As shown, the biosensor 314 is received in a side groove 332 extending along the length of the cannula 212T, transitions into a passage 334 formed in the threaded portion 331, and then extends laterally through the passage 334 to connect to transmitter electronics 336 (such as a circuit board) or other similar electronic components (including other electronics coupled to or configured to be coupled to the transmitter and sensor assembly 330). Therefore, when the cannula 212T is inserted into the user's skin and then withdrawn from the user's skin, the biosensor 314 can be held in place by removing it from the passage 334 and the side groove 332.

[0050] During operation, the cannula assembly 212 can be actuated by contacting the fork 316F of the pivot member 316 during insertion stroke to insert the biosensor 314 into the user's skin. Specifically, the cannula assembly 212 can be actuated by a wing 212W of the body 312B, which is received in a recess in an end opening formed in the fork 316F of the pivot member 316. Further, 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 engages and provides anti-rotation support.

[0051] like Figure 3AAs shown, the contact member 104 may be configured to be concentric with and extend and retract with the push member 102. In some embodiments, the contact member 104 may include a first alignment feature, such as a vertically extending groove or recess, and the transmitter carrier 318 may include a second alignment feature, such as a vertically extending finger-like projection, which mates with the first alignment feature. Such alignment features can keep the contact member 104 and the transmitter carrier 318 rotationally aligned to prevent rotation between them, such as during the insertion and retraction portions of the stroke. The cross-sections of the push member 102 and the contact member 104 may be oval or rectangular 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.

[0052] Now for reference Figure 4-7 Describe the operation of the biosensor inserter 100. Figure 4-7 A cross-sectional side view of the biosensor inserter 100 is shown during various portions of the journey of an insertion method operable to insert the biosensor 314, according to an embodiment provided herein. Additionally, Figure 8 A flowchart is shown of a method 800 for inserting a biosensor 314 using a biosensor inserter 100 according to an embodiment provided herein.

[0053] To begin Figure 8 The insertion method 300 involves removing the needle cap (not shown) from the threaded portion 331 of the cannula assembly 212 of the biosensor inserter 100. The biosensor inserter 100 is then positioned to contact the skin around the user's desired insertion site (such as the upper arm, abdominal area, or other suitable location).

[0054] 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, while the latch end 316L moves linearly along the wall relative to the latch 104L.

[0055] During the first portion of the stroke in method 800, pivoting of the pivot member 316 is prevented by contact between the latch end 316L and the wall of the contact member 104. Consequently, the transmitter carrier 318 and the coupled transmitter and sensor assembly 330 translate toward the insertion site.

[0056] like Figure 4As shown, 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 through 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., via an adhesive material) to the user's skin around the insertion site. The cannula 212T and biosensor 314 enter the insertion site, where the biosensor 314 can contact the interstitial fluid in the subcutaneous region. For example, the biosensor 314 may be placed 4 mm to 6 mm into the skin, but other depths are also possible.

[0057] like Figure 5 As shown, after the biosensor 314 is inserted (including the adhesion 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 pivot member 316 moves past the latch 104L at the beginning of the second portion of the stroke, the pivot member 316 is allowed to pivot via the actuating element 102P, rotating about the pivot 318P below the latch 104L and into the incision portion 338. This pivoting causes the cannula assembly 212 to retract during the second portion of the stroke.

[0058] During retraction, the pivot member 316 pivots on the transmitter carrier 318 due to the force 108 applied by the actuating element 102P on the pivot member 316. When 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 pivot member 316. Finally, as... Figure 5 As shown, the pivot member 316 fully pivots to completely remove the cannula assembly 212 from the user's skin, leaving the implanted biosensor 314 therein. As the push member 102 continues to be pushed further, the cannula assembly 212 retracts along the slot 220 and passes through the retaining feature 220R. Additionally, the cannula assembly 212 retracts into the sheath portion 205S of the cannula retainer 105 and is thus securely held.

[0059] The biosensor inserter 100 can then be removed, leaving the transmitter and sensor assembly 330 in place, wherein the bottom surface of the transmitter and sensor assembly 330 adheres to the user's skin at the insertion site, and the biosensor 314 is in contact with the user's interstitial fluid.

[0060] Before or after removing the biosensor inserter 100, the cannula retainer 105, which houses and holds the cannula assembly 212, can be removed, such as Figure 6 As shown. The cannula assembly 212 is secured in the cannula holder 105 and can be disposed of together with it as medical waste.

[0061] In some embodiments, the actuating member 102, the contact member 104, the pivot member 316, and the transmitter carrier 318 are formed of recyclable or biodegradable materials, and these components are recyclable or compostable. Therefore, it should be recognized that the biosensor inserter 100 of this disclosure significantly reduces the amount of medical waste and increases the amount of recyclable or biodegradable materials.

[0062] Figure 7 An exploded view of the various components of the biosensor inserter 100 is shown.

[0063] Now for reference Figure 8 This describes an embodiment of a method 800 for inserting a biosensor (e.g., biosensor 314) into a user using a biosensor inserter (e.g., biosensor inserter 100). 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 holder (e.g., cannula holder 105) inserted into the receiver, the cannula holder including a sheath portion (e.g., sheath portion 205S), 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 cannula (e.g., cannula 212T).

[0064] 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 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.

[0065] Further, method 800 includes, in block 808, continuing to push the 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 implanting the biosensor (e.g., biosensor 314). Finally, method 800 includes, in block 810, removing the cannula retainer (e.g., cannula retainer 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 retainer 105 and the cannula assembly 212 can be disposed of as medical waste along with the skirt 104S. The remainder of the biosensor inserter 100 can be recycled.

[0066] The above description discloses only exemplary embodiments. Modifications to the apparatus and methods disclosed above that fall within the scope of this disclosure will be readily apparent to those skilled in the art.

Claims

1. A biosensor inserter configured to insert a biosensor, the biosensor inserter comprising: A pushing member, the pushing member including a receiver; A contact member, the contact member being capable of translation relative to the pushing member; A cannula retainer configured to receive a cannula assembly including a cannula, the cannula retainer being configured to be inserted into and removed from the receiver. A transmitter carrier, which is translatable relative to the contact member, is configured to support the transmitter and sensor assembly during insertion of the biosensor; and A pivot member configured to pivot on the transmitter carrier, the pivot member including a latching end and a forked end, the forked end including a first fork and a second fork spanning the sheath portion of the cannula retainer. The first fork and the second fork are detachably connected to the cannula assembly.

2. The biosensor inserter of claim 1, wherein the receiver includes a recess formed in the top of the push member.

3. The biosensor inserter of claim 1, wherein the cannula retainer further includes a gripping portion, wherein after insertion of the biosensor, the cannula assembly is retractable into the sheath portion.

4. The biosensor inserter of claim 1, wherein the cannula retainer comprising the cannula assembly is removable from the receiver of the push member.

5. The biosensor inserter of claim 1, wherein the transmitter carrier includes an aperture configured to receive the sheath portion during the insertion of the biosensor.

6. The biosensor inserter of claim 1, wherein the first fork and the second fork each include an open groove formed therein and configured to receive a wing of the cannula assembly therein.

7. The biosensor inserter of claim 1, wherein the actuating member further comprises an actuating element configured to engage with the pivot member.

8. The biosensor inserter of claim 1, wherein the sheath portion includes a slot formed in a side of the sheath portion, the slot being configured to receive a wing of the cannula assembly.

9. A biosensor inserter, the biosensor inserter comprising: A pushing member having a pushing element and a receiving device; A cannula retainer, the cannula retainer including a sheath portion, wherein the cannula retainer is received in the receiver; A contact member configured to extend or retract relative to the actuating member; A transmitter carrier configured to support the transmitter and sensor assembly during insertion of the biosensor; A pivot member configured to pivot on the transmitter carrier; A cannula assembly, the cannula assembly including a cannula, the cannula assembly being supported by the pivot member during insertion and retraction and being receptive to the sheath portion upon retraction; and The mechanism is configured to translate the transmitter carrier toward the user's skin, such that the cannula and the biosensor are inserted during the insertion portion of the biosensor inserter's stroke. in, The mechanism is further configured to restrict the pivoting of the pivot member during the insertion portion of the stroke and to pivot the pivot member during the retraction portion of the stroke to retract the cannula assembly for implantation of the biosensor.

10. The biosensor inserter of claim 9, wherein the contact member and the transmitter carrier are rotate-aligned using one or more alignment features.

11. The biosensor inserter of claim 9, wherein the cannula retainer is configured to be inserted into and removed from the receiver, and is configured to be removed from the receiver together with the cannula assembly after the cannula assembly is retracted into the sheath portion.

12. The biosensor inserter of claim 11, wherein the pivot member includes a bifurcated end, the bifurcated end including a first fork and a second fork across the sheath portion of the cannula retainer.

13. The biosensor inserter of claim 12, wherein the first fork and the second fork each include an open groove configured to receive a corresponding wing of the cannula assembly therein.

14. The biosensor inserter of claim 11, wherein the transmitter carrier is translatable relative to the contact member.

15. The biosensor inserter of claim 11, further comprising a skirt removably fastened to the upper portion of the contact member.

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