Patent Description:
The present disclosure relates to a biosensor inserter configured to insert a biosensor, which can be part of continuous analyte monitoring.

Continuous glucose monitoring, such as with a continuous glucose monitor (CGM) has become a routine sensing operation, particularly for sensing in diabetes care. By providing real-time glucose monitoring that provides glucose concentrations over time, therapeutic actions, such as insulin introduction, may be applied in a timely manner and the glycemic condition may be better controlled.

During a CGM operation, a biosensor of a transmitter and sensor assembly is inserted subcutaneously and is continuously operated in an environment surrounded by tissue and interstitial fluid (ISF). The biosensor is inserted under the skin and provides a signal to a transmitter of the transmitter and sensor assembly, and that signal can be indicative of a patient's blood glucose level, for example. These sensor measurements may be made intermittently and automatically many times throughout the day (e.g., every few minutes or other suitable interval).

The transmitter of the transmitter and sensor assembly is adhered to the outer surface of a user's skin, such as on the abdomen, on the back of the upper arm, or at another suitable location, while the biosensor is inserted through the skin so as to contact ISF. This skin insertion process may be referred to as "insertion. " Devices for carrying out this biosensor insertion may be referred to as "biosensor inserters.

Biosensor inserter designs may be complicated and costly to manufacture. Moreover, some biosensor inserters are discarded as medical waste following their use. Reference is made to the following prior art applications, Document <CIT> describes an inserter for a medical device that utilizes a cam gear assembly to drive a lancet plunger assembly. Document <CIT> describes a sensor insertion device that is spring-loaded to retract a needle from a patient, and Document <CIT> describes a device for automatic insertion of a sensor that is spring-loaded to retract a penetrating member from a patient.

In some embodiments, a biosensor inserter is provided. The biosensor inserter includes a push member having a push element and a receiver; a trocar holder including a sheath portion, wherein the trocar holder is received in the receiver; a contact member configured to telescope relative to the push member; a transmitter carrier configured to support a transmitter and sensor assembly during insertion of the biosensor; a pivot member configured to pivot on the transmitter carrier; and a trocar assembly including a trocar, the trocar assembly supported by the pivot member and receivable in the sheath portion upon retraction; and a mechanism configured to translate the transmitter carrier toward a user's skin so that the trocar and the biosensor are inserted therein during an insertion portion of a stroke of the biosensor inserter, wherein the mechanism is further configured to restrain the pivot member from pivoting during the insertion portion of the stroke and to pivot the pivot member, thereby retracting the trocar assembly in a retraction portion of the stroke while leaving the biosensor implanted.

In yet further embodiments, a method of using a biosensor inserter to insert a biosensor into a user is provided. The method includes providing the biosensor inserter comprising: a push member including a receiver, a trocar holder inserted in the receiver, the trocar holder including a sheath portion, a contact member translatable relative to the push member, a transmitter carrier configured to support a transmitter and sensor assembly during insertion of the biosensor, a pivot member configured to pivot on the transmitter carrier, and a trocar assembly including a trocar having the biosensor therein; contacting the contact member to skin of the user; pushing on the push member to cause insertion of the trocar and the biosensor into the skin in an insertion portion of a stroke, wherein the pivot member is restrained from pivoting in the insertion portion; continuing to push the push member to retract the trocar assembly into the sheath portion via pivoting of the pivot member in a retraction portion of the stroke, while leaving the biosensor implanted; and removing the trocar holder and the trocar assembly from the receiver.

Other features, aspects, and advantages of embodiments in accordance with the present disclosure will become more fully apparent from the following detailed description, the claims, and the accompanying drawings by illustrating a number of example embodiments. Various embodiments in accordance with the present disclosure may also be capable of other and different applications, and its several details may be modified in various respects, all without departing from the scope of the claims.

Thus, the description is to be regarded as illustrative in nature, and not as restrictive.

The drawings are to be regarded as illustrative in nature, and not as restrictive. The drawings are not necessarily drawn to scale. Like numerals are used throughout the drawings to denote like elements.

A biosensor inserter is configured to implant (insert) a biosensor of a transmitter and sensor assembly into the skin of a person. In conventional biosensor inserters, a trocar assembly is used as part of the biosensor inserter wherein the trocar thereof aids in the insertion of the biosensor into the person. Once the biosensor insertion process is performed, the trocar assembly and trocar is retracted and generally remains inside of the biosensor inserter. Because blood may contaminate the trocar and biosensor inserter, conventional biosensor inserters are treated as a biohazard and are disposed of as medical waste, much like sharps.

Embodiments of the present disclosure operate to reduce the amount of medical waste generated by these biosensor inserters upon being used. This is accomplished by isolating the trocar assembly and trocar from the remaining part of the biosensor inserter. In one or more embodiments described herein, a biosensor inserter is provided that has parts thereof that are designed to be recycled, while other components are removable and are treatable as medical waste. Thus, the amount of medical waste is dramatically reduced, and the amount of recyclable material is increased. In accordance with some embodiments of the disclosure, after performing the insertion process with the biosensor inserter, a trocar holder carrying the trocar assembly is separated from the recyclable components by having the trocar assembly and trocar enclosed in a sheath portion of the removable trocar holder. Thus, after removal, the trocar holder and trocar contained therein can be discarded as medical waste. The remaining portions of the biosensor inserter can be recycled.

The biosensor inserter includes 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 transmitter carrier that holds a transmitter and biosensor assembly during insertion of the biosensor. As the push member is pushed by the user, the transmitter carrier is translated toward a user's skin and the trocar and biosensor are inserted therein during a first portion of a stroke of the biosensor inserter. Continuing to push on the push member retracts the trocar, leaving the biosensor implanted in the user's skin.

In one or more embodiments, the push member includes a trocar holder that is registerable in a receiver of the push member and that is configured to contain the trocar assembly in a sheath portion after the insertion process is completed, wherein the trocar holder and trocar can be removed from the push member as a unit and discarded as medical waste. The push member, inner insertion/retraction mechanism, and contact member can be treated as recyclable material, since they would not be exposed to blood, nor would they contain any sharps. The largest volume of material is contained in the push member, inner insertion/retraction mechanism, and the contact member, thus only a small amount of material is considered medical waste, namely the trocar holder and trocar assembly. A trocar may also be referred to as an insertion portion.

In some embodiments, a skirt portion of the contact member, that is configured to be in contact with the person's skin, can be removable and can be removed and discarded as medical waste if it, has been contaminated by blood. Otherwise, it can be recycled.

<FIG> illustrate various views of an embodiment of the biosensor inserter <NUM> including a push member <NUM> configured to be pushed by the user to cause insertion of the biosensor <NUM> (shown in <FIG>) and a contact member <NUM> that is translatable (e.g., capable of telescoping) relative to the push member <NUM>. Contact member <NUM> is configured to be in contact with the user's skin during biosensor insertion process. In the depicted embodiment, the push member <NUM> includes a receiver <NUM>, which can be a pocket or other suitable opening. One type of mechanism <NUM> (<FIG>) of the biosensor inserter <NUM> is shown, which is operational to insert a trocar 212T of a trocar assembly <NUM> along with the biosensor <NUM> (<FIG>) and then retract the trocar assembly <NUM> and trocar 212T.

Further, biosensor inserter <NUM> includes a trocar holder <NUM> configured to hold the trocar assembly <NUM> after use so that it can be properly disposed of. The trocar holder <NUM> may provide a secondary function of providing a guide for the proper alignment of the trocar assembly <NUM> during insertion. For example, a body 312B (<FIG>) of the trocar assembly <NUM> may have a shape, such as rectangular cross-sectional shape shown, that is similar to, but slightly smaller than an internal shape of an internal channel (e.g., hollow interior 205I - <FIG>) formed in the sheath portion <NUM> of the trocar holder <NUM> such that the body 312B of the trocar assembly <NUM> can slide in the hollow interior 205I, but not rotate or tilt therein. The trocar holder <NUM> is configured to be insertable into, and removable from, the receiver <NUM>. Thus, the trocar holder <NUM> and trocar assembly <NUM> are removable (can be removed from) from the receiver <NUM> of the push member <NUM> and safely discarded as medical waste after use.

Again referring to the trocar assemblies <NUM> shown in <FIG> and <FIG>, the body 312B of the trocar assembly <NUM> can include wings 212W extending laterally therefrom. The wings 212W ride in the slots <NUM> formed in sides of the sheath portion <NUM> of the trocar holder and can snap past one or more retention features 220R upon retraction of the trocar assembly <NUM>. Thus, the slots <NUM> formed in sides of the sheath portion <NUM> are configured to receive wings 212W of the trocar assembly <NUM>. The one or more retention features 220R can be configured to secure the trocar assembly <NUM> to the sheath portion <NUM>. Further, the one or more retention features 220R can comprise a narrowed portion of a slot <NUM> formed in one or more sides of the sheath portion <NUM> that are configured to receive wings 212W of the trocar assembly <NUM>. As shown in <FIG>, forks 316F of the pivot member <NUM> engage the wings 212W of the trocar assembly <NUM> to drive same and cause biosensor insertion and thereafter retraction. In particular, the pivot member <NUM> comprises a forked end including forks 316F with a first fork and a second fork that can straddle the sheath portion <NUM> of the trocar holder <NUM>, wherein each fork 316F can include an open-ended groove configured to receive the wings 212W therein.

Receiver <NUM> may be a pocket formed in a top portion of the push member <NUM> in some embodiments. For example, as shown in <FIG>, the receiver <NUM> can be formed in a top and/or side(s) of the push member <NUM>. As shown, the grasping portion <NUM> of the trocar holder <NUM> is configured to be grasped by a thumb and finger of the user. Any suitable surface feature 105F or features that enhance gripping of the trocar holder <NUM> can be added to the side surfaces of the grasping portion <NUM>, such as by adding a raised portion (e.g., raised rib) as shown. Optionally one or more indented portions or other grip feature may be provided to enhance gripping. Additionally, as shown in <FIG> and <FIG>, retention features may be added to the trocar holder <NUM>, such as to grasping portion <NUM>. Retention features in this embodiment can comprise holes <NUM> formed in tabs of the sides of the gripping portion <NUM> as shown. The holes <NUM> can register with pilots 305P (<FIG>) formed on the body portion of the push member <NUM>.

<FIG> further illustrates the sheath portion <NUM> of the trocar holder <NUM> in more detail. Trocar holder <NUM> includes the sheath portion <NUM> extending from the grasping portion <NUM>. Sheath portion <NUM> includes a hollow interior 205I that can receive a portion of the trocar assembly <NUM> therein. After the insertion of the biosensor <NUM>, the trocar assembly <NUM> is retractable by pivot member <NUM> into the hollow interior 205I of the sheath portion <NUM>, similar to what is shown in <FIG> and <FIG>.

As shown, the sharp end of the trocar 212T can be retracted so that it is located fully inside of the hollow interior 205I so that the sharp end is sheathed and this contact therewith is minimized. This is achieved by the pivoting of the pivot member <NUM> as shown in <FIG>, which moves the wings 212W of the trocar assembly <NUM> up in the slots <NUM> past the retention features 220R and effectively locks the wings 212W into the retention area 220A (See <FIG>) of the trocar assembly <NUM> where the wings 212W are held securely so that the trocar assembly <NUM> cannot fall out of the sheath portion <NUM>.

As the trocar assembly <NUM> is captured within the hollow interior 205I, the user can squeeze the opposing side tabs 105T of the grasping portion <NUM> sufficiently to move the holes <NUM> past the pilots 305P and thus remove the trocar holder <NUM> along with the trocar assembly <NUM>. Thus, the material considered medical waste can be isolated away from the remaining recyclable portion. The trocar holder <NUM> along with the trocar assembly <NUM> can then be disposed as medical waste. Similarly, in a separate step, the skirt <NUM> can also be removed and disposed of as medical waste, if contaminated. Skirt <NUM> may be part of the contact member <NUM> and may slip over, or otherwise be removably fastened to, the upper portion 104U of the contact member <NUM>.

<FIG> and <FIG> illustrate the mechanism <NUM> of the biosensor inserter <NUM>. In some embodiments, the pivot member <NUM>, which contacts and operatively drives the trocar assembly <NUM>, is restrained from pivoting as the transmitter carrier <NUM> translates toward a user's skin during a first portion (insertion portion) of the stroke of the biosensor inserter <NUM>, but is allowed to pivot once delatched after the biosensor <NUM> is implanted in a user's skin. Once delatched, the pivot member <NUM> may pivot in a second portion of the stroke of the biosensor inserter <NUM>, which causes the retraction (the retraction portion of the stroke) of the trocar assembly <NUM> and leaves the biosensor <NUM> inserted into the user's skin. Thus, the pivot member <NUM> does not pivot in the first portion of the stroke, and does pivot in a second (retraction) portion of the stroke. The transmitter carrier <NUM> is translatable relative to the contact member <NUM> and is configured to support a transmitter and sensor assembly <NUM> during insertion of a biosensor <NUM> (<FIG>). The transmitter carrier <NUM> may include an aperture <NUM> configured to receive the sheath portion <NUM> therein during insertion. Other suitable mechanisms for insertion and retraction may be used.

<FIG> and <FIG> further illustrate cross-sectional side views of a biosensor inserter <NUM> shown in various portions of the stroke in accordance with one or more embodiments provided herein. The contact member <NUM> includes an upper portion 104U and a skirt <NUM> at the lower end. Lower end, which may be part of skirt <NUM>, may contact a user's skin during insertion and retraction of the trocar assembly <NUM> to implant a biosensor <NUM>. Contact member <NUM> further includes a latch <NUM>, which has a latch surface (lower latch surface) that once passed by via motion of a latch end <NUM> of the pivot member <NUM> will allow the pivot member <NUM> to rotate (<FIG>). The pivot member <NUM> can be configured to pivot on the transmitter carrier <NUM>, such as about pivot 318P.

For example, pivot 318P may include laterally extending features (e.g., posts) formed on the pivot member <NUM> that interface with holes or recesses formed in first and second side supports of transmitter carrier <NUM> (see <FIG>) to form a pivot axis. Thus, the pivot member <NUM> is pivotable about the pivot axis and pivots on the pivot of 318P formed by transmitter carrier <NUM> and pivot member <NUM>.

A pivot location of the pivot 318P can be formed between the latch end <NUM> and the opposite end of pivot member <NUM> containing the forks 316F. Other suitable laterally extending features may be used to form the pivot 318P, and other pivot mechanisms may be used, such as a removable axle, or the like.

Latch <NUM> may be formed as an opening in the sidewall of the contact member <NUM>. The latch <NUM> can comprise a circumferentially disposed surface of a width that can be wider than the latch end <NUM> of the pivot member <NUM>. Up until when the latch end <NUM> passes by the latch <NUM>, the pivot member <NUM> is restrained from rotation about pivot 318P. As shown, latch <NUM> is part of a vertically extending cutout that may be closed at its lower end by skirt <NUM>. Once past the latch <NUM>, the pivot member <NUM> may rotate.

As shown in <FIG>, push member <NUM> may include a push element 102P, which can be a rigid member that extends downwardly (as oriented in <FIG>) from the underside of push member <NUM> and includes a contact end that engages with pivot member <NUM>. Push element 102P engages with pivot member <NUM> and causes rotation (pivoting) thereof as well as translation of the transmitter carrier <NUM>. Transmitter carrier <NUM> can be received within the contact member <NUM> and can have a transmitter and sensor assembly <NUM> coupled thereto. Transmitter and sensor assembly <NUM> includes the transmitter electronics and radio that can be used to communicate measured analyte values and/or other data received from the implanted biosensor <NUM> to a reader, smartphone executing a suitable application, or other apparatus for processing and displaying analyte values, including trends. Transmitter and sensor assembly <NUM> further includes a biosensor <NUM> coupled thereto, which has a reading end that is received inside of the trocar 212T and is inserted with the aid of the trocar 212T and after which the trocar 212T is removed and the biosensor <NUM> remains implanted in the person.

In operation, the transmitter and sensor assembly <NUM> can be detachably coupled to the transmitter carrier <NUM>. Transmitter and sensor assembly <NUM> can include an adhesive layer to adhere the transmitter and sensor assembly <NUM> to the user's skin upon retraction of the trocar assembly <NUM>. Any suitable mechanism that allows detachment of the transmitter and sensor assembly <NUM> from the transmitter carrier <NUM> may be used, such as a pressure sensitive adhesive, a slight interference fit, a low-release force retention mechanism, or the like.

In some embodiments, the push member <NUM>, contact member <NUM>, pivot member <NUM>, and/or transmitter carrier <NUM> may be formed from a biodegradable and/or recyclable material (e.g., a recyclable plastic, a biodegradable paper product, bamboo, etc.). In particular, in some embodiments, recyclable plastics may be used for the above-listed components, including, but not limited to, polyethylene terephthalate (PET), high-density polyethylene (HDPE), low-density polyethylene (LDPE), polyvinyl chloride, polypropylene, polystyrene, and the like.

In more detail, the transmitter carrier <NUM> is axially translatable relative to the contact member <NUM> and is configured to support the transmitter and sensor assembly <NUM> during insertion of the biosensor <NUM>. In particular, the transmitter and sensor assembly <NUM> may include transmitter electronics <NUM>, a power source (not shown), and a biosensor assembly that includes the biosensor <NUM>.

The transmitter and sensor assembly <NUM> may include transmitter electronics <NUM> (<FIG>) that may include an analog front end for biasing the biosensor <NUM> and for sensing current that passes through the biosensor <NUM>, such as an operational amplifier or amplifiers, current sensing circuitry, processing circuitry such as an analog-to-digital converter for digitizing current signals, memory for storing digitized current signals, a controller such as a microprocessor, microcontroller or the like for possibly computing analyte concentration values based on measured current signals, and transmitter circuitry for transmitting analyte concentration values to the external device (e.g., a smart phone or another suitable external reader device configured to store and/or displaying analyte concentrations).

In some embodiments, the biosensor <NUM> used within the transmitter and sensor assembly <NUM> may include two electrodes and the bias voltage may be applied across the pair of electrodes. In such cases, current may be measured through the biosensor <NUM>. In other embodiments, the biosensor <NUM> may include three electrodes such as a working electrode, a counter electrode, and a reference electrode. In such cases, the bias voltage may be applied between the working electrode and the reference electrode, and current may be measured through the working electrode, for example. The biosensor <NUM> may include an active region including one or more chemicals that undergo an analyte-enzyme reaction with the products they detect. The enzyme can be immobilized on one or more electrodes to provide a reaction (e.g., redox reaction) with the analyte and generate a current at the electrodes. Example chemicals include glucose oxidase, glucose dehydrogenase, or the like for measuring glucose as an analyte. In some embodiments, a mediator such as ferricyanide or ferrocene may be employed at the active region. In general, any analyte that may be detected and/or monitored with a suitable biosensor and for which suitable chemistry exists may be measured, such as glucose, cholesterol, lactate, uric acid, alcohol, or the like. An analyte is defined herein as a component, substance, chemical species, or chemical constituent that is measurable in an analytical procedure.

An example of the biosensor <NUM> can be any suitable implantable sensor that can be implanted in the skin of a user, such as a strand-shaped sensor shown in <FIG> that is able to be received inside of a side groove <NUM> formed lengthwise in the trocar 212T of the trocar assembly <NUM> and that is able to sense an analyte concentration of an interstitial fluid under the skin.

Trocar 212T of trocar assembly <NUM> may be made, for example, from a metal such as stainless steel, or a non-metal such as plastic. Other suitable materials may be used. In some embodiments, trocar 212T may be have a lengthwise formed side groove <NUM> formed from, but not limited to, a round C-channel tube, a round U-channel tube, a stamped sheet metal part folded into a U-profile in cross-section, a molded/cast metal part with a U-channel profile in cross-section, or a solid metal cylinder with an etched or ground channel causing a U-shapes cross-section. Other trocar shapes may be used that allow insertion and retraction, while leaving behind the implanted biosensor <NUM>.

Body 312B of trocar assembly <NUM> may be formed from a suitable plastic, for example, such as, but not limited to, acrylonitrile butadiene styrene (ABS), polycarbonate, nylon, acetal, polyphthalamide (PPA), polysulfone, polyethersulfone, polyetheretherketone (peek), polypropylene, high-density polyethylene (HDPE), and low-density polyethylene (LDPE). Other suitably rigid materials may be used.

As best shown in <FIG>, the biosensor <NUM> is received in the side groove <NUM> of the trocar 212T, that extends along the length of the trocar 212T, and transitions into a passage <NUM> formed in the threaded portion <NUM>, and then passes laterally out of passage <NUM> to connect to the transmitter electronics <NUM> such as an electrical circuit board, or other like electronic component including, coupled to, or configured to couple to other electronics of the transmitter and sensor assembly <NUM>. Thus, upon insertion and then retraction of the trocar 212T in and from the user's skin, the biosensor <NUM> can remain in place by being removed from passage <NUM> and the side groove <NUM>.

In operation, the trocar assembly <NUM> can be drivable by being contacted by the forks 316F of the pivot member <NUM> in an insertion stroke to insert the biosensor <NUM> into the user's skin. In particular, trocar assembly <NUM> is drivable by the wings 212W of the body 312B being received in the open-ended grooves formed in the forks 316F of the pivot member <NUM>. Further, the body 312B may include a rectangular portion that is received in a like rectangular portion of the hollow interior 205I. As discussed above, the rectangular portions may interface and provide an anti-rotation support.

As best shown in <FIG>, contact member <NUM> may be configured to be concentric with push member <NUM> and may be telescopic therewith. In some embodiments, contact member <NUM> may include a first alignment feature such as a vertically extending groove or recess, and transmitter carrier <NUM> may include a second alignment feature, such as a vertically extending finger tab, that interfaces with the first alignment feature. Such alignment features may hold contact member <NUM> and transmitter carrier <NUM> in rotational alignment to prevent rotation there between, such as during the insertion and retraction portions of the stroke. Push member <NUM> and contact member <NUM> may be oval or oblong as shown, or optionally circular, elliptical, or any other suitable shape in transverse cross-section. In some embodiments, push member <NUM> and contact member <NUM> may not be concentric.

Operation of the biosensor inserter <NUM> is now described with reference to <FIG>, which illustrate cross-sectional side views of the biosensor inserter <NUM> during various portions of the stroke of the insertion method operative to insert a biosensor <NUM> in accordance with embodiments provided herein. In addition, <FIG> illustrates a flowchart of a method <NUM> of using a biosensor inserter <NUM> to insert a biosensor <NUM> in accordance with embodiments provided herein.

To begin the insertion method <NUM> of <FIG>, a needle cover (not shown) can be removed from threaded portion <NUM> of trocar assembly <NUM> of the biosensor inserter <NUM>. The biosensor inserter <NUM> is placed in contact with the skin surrounding a desired insertion site of a user, such as on an upper arm, an abdomen region, or another suitable location.

To begin insertion, a force <NUM> is applied to the push member <NUM> by a user so as to cause the push member <NUM> to translate relative to the contact member <NUM> and move toward the insertion site. Movement of push member <NUM> over the contact member <NUM> causes push element 102P to contact the pivot member <NUM>, which causes transmitter carrier <NUM> and pivot member <NUM> to translate and move toward the insertion site with the latch end <NUM> moving linearly relative toward the latch <NUM> along the wall.

During this first portion of the stroke of the method <NUM>, pivot member <NUM> is prevented from pivoting via the contact of the latch end <NUM> with the wall of the contact member <NUM>. Thus, transmitter carrier <NUM> and coupled transmitter and sensor assembly <NUM> translate toward the insertion site.

As shown in <FIG>, transmitter carrier <NUM> and transmitter and sensor assembly <NUM> continue to move toward the insertion site and trocar 212T makes contact and enters insertion site of the skin, and a bottom surface of transmitter and sensor assembly <NUM> contacts the skin around the insertion site. In some embodiments, bottom surface of transmitter and sensor assembly <NUM> may adhere (e.g., via an adhesive material) to the user's skin surrounding the insertion site. The trocar 212T and biosensor <NUM> enters the insertion site where biosensor <NUM> can make contact with interstitial fluid in the subcutaneous region. The biosensor <NUM> can be placed <NUM> to <NUM> into the skin, for example, although other depths may be used.

As shown in <FIG>, following insertion of the biosensor <NUM> (including adhesion of the transmitter and sensor assembly <NUM> to the skin around the insertion site), the push member <NUM> continues to move relative to the contact member <NUM> in a second portion of the stroke. When the latch end <NUM> of the pivot member <NUM> moves past the latch <NUM> at the start of the second portion of the stroke, the pivot member <NUM> is allowed to pivot via the pushing by push element 102P, rotate under latch <NUM> about pivot 318P and into cutout portion <NUM>. The pivoting causes the retraction of the trocar assembly <NUM> in the second portion of the stroke.

During the retraction, pivot member <NUM> pivots on the transmitter carrier <NUM> due to the force <NUM> applied by push element 102P on pivot member <NUM>. As this occurs, trocar assembly <NUM> retracts from the insertion site and moves away from transmitter and sensor assembly <NUM>, which is adhered to the user. As the push member <NUM> continues to move relative to the contact member <NUM> toward the insertion site, push element 102P continues to press against pivot member <NUM>. Eventually, as shown in <FIG>, pivot member <NUM> pivots sufficiently for trocar assembly <NUM> to be completely removed from the user's skin and leaves the implanted biosensor <NUM> therein. As the push member <NUM> is continued to be pushed further, the trocar assembly <NUM> is retracted along slots <NUM> and past retention feature 220R. Additionally, the trocar assembly <NUM> is retracted into the sheath portion <NUM> of the trocar holder <NUM> and securely held thereby.

Biosensor inserter <NUM> then may be removed, leaving transmitter and sensor assembly <NUM> in place, with the bottom surface of transmitter and sensor assembly <NUM> adhered to the user's skin at the insertion site and biosensor <NUM> in contact with interstitial fluid of the user.

Before or after removal of the biosensor inserter <NUM>, the trocar holder <NUM> with the trocar assembly <NUM> contained and held therein can be removed, such as shown in <FIG>. The trocar assembly <NUM> is secured in the trocar holder <NUM> and can be discarded therewith as medical waste.

In some embodiments, the push member <NUM>, contact member <NUM>, pivot member <NUM>, and transmitter carrier <NUM> are formed of recyclable or biodegradable material, and these components may be recycled or composted. Thus, it should be recognized that biosensor inserters <NUM> of the present disclosure dramatically reduce the amount of medical waste and increase the amount of recyclable or biodegradable material.

<FIG> illustrates an exploded view of various components of the biosensor inserter <NUM>.

Referring now to <FIG>, an embodiment of a method <NUM> of using a biosensor inserter (e.g., biosensor inserter <NUM>) to insert a biosensor (e.g., biosensor <NUM>) into a user is described. The method <NUM> comprises, in block <NUM>, providing the biosensor inserter (e.g., biosensor inserter <NUM>) comprising: a push member (e.g., push member <NUM>) including a receiver (e.g., receiver <NUM>), a trocar holder (e.g., trocar holder <NUM>) inserted in the receiver, the trocar holder including a sheath portion (e.g., sheath portion <NUM>), and a contact member (e.g., contact member <NUM>) translatable relative to the push member, and a trocar assembly (e.g., trocar assembly <NUM>) including a trocar (e.g., trocar 212T).

The method <NUM> further comprises, in block <NUM>, contacting the contact member (e.g., contact member <NUM>) to skin of the user, and in block <NUM>, pushing on the push member (e.g., push member <NUM>) to cause insertion of the trocar (e.g., trocar 212T) and biosensor (e.g., biosensor <NUM>) into the skin. The pushing (force <NUM>) causes the transmitter carrier (e.g., transmitter carrier <NUM>) to translate relative to the contact member.

Further, the method <NUM> comprises, in block <NUM>, continuing to push the push member (e.g., push member <NUM>) to retract the trocar assembly (e.g., trocar assembly <NUM>) into the sheath portion (e.g., sheath portion <NUM>), while leaving the biosensor (e.g., biosensor <NUM>) implanted. Finally, the method <NUM> comprises, in block <NUM>, removing the trocar holder (e.g., trocar holder <NUM>) and trocar assembly (e.g., trocar assembly <NUM>) from the receiver (e.g., receiver <NUM>). Following removal, the trocar holder <NUM>, and trocar assembly <NUM> may be discarded as medical waste, along with the skirt <NUM>, if contaminated with blood. The remainder of the biosensor inserter <NUM> can be recycled.

Claim 1:
A biosensor inserter (<NUM>), comprising:
a push member (<NUM>) having a push element (102P) and a receiver (<NUM>);
a trocar holder (<NUM>) including a sheath portion (<NUM>), wherein the trocar holder (<NUM>) is received in the receiver (<NUM>);
a contact member (<NUM>) configured to telescope relative to the push member (<NUM>);
a transmitter carrier (<NUM>) configured to support a transmitter and sensor assembly (<NUM>) during insertion of a biosensor (<NUM>);
a pivot member (<NUM>) configured to pivot on the transmitter carrier (<NUM>);
a trocar assembly (<NUM>) including a trocar (212T), the trocar assembly (<NUM>) supported by the pivot member (<NUM>) and receivable in the sheath portion (<NUM>) upon retraction; and characterised by
a mechanism (<NUM>) configured to translate the transmitter carrier (<NUM>) toward a user's skin so that the trocar (212T) and the biosensor (<NUM>) are inserted therein during an insertion portion of a stroke of the biosensor inserter,
wherein the mechanism (<NUM>) is further configured to restrain the pivot member (<NUM>) from pivoting during the insertion portion of the stroke and to pivot the pivot member (<NUM>), thereby retracting the trocar assembly (<NUM>) in a retraction portion of the stroke while leaving the biosensor (<NUM>) implanted.