Patent Description:
Analyte monitoring in an individual may take place periodically or continuously over a period of time. Periodic analyte monitoring may take place by withdrawing a sample of bodily fluid, such as blood, at various time intervals and analyzing ex vivo. Continuous analyte monitoring may be conducted using one or more sensors that remain at least partially implanted within a tissue of an individual, such as dermally, subcutaneously, or intravenously, so that analyses may be conducted in vivo. Implanted sensors may collect analyte data continuously or sporadically (usually at regular intervals), depending on an individual's particular health needs and/or previously measured analyte levels.

Periodic ex vivo analyte monitoring can be sufficient to determine the physiological condition of many individuals. However, ex vivo analyte monitoring may be inconvenient or painful for some individuals. Moreover, there is no way to recover lost data if a measurement is not obtained at an appropriate time.

Continuous analyte monitoring with an in vivo implanted sensor may be a more desirable approach for individuals having severe analyte dysregulation and/or rapidly fluctuating analyte levels, although it can also be beneficial for other individuals as well. While continuous analyte monitoring with an implanted sensor can be advantageous, there are challenges associated with these types of measurements. Intravenous analyte sensors have the advantage of providing analyte concentrations directly from blood, but they are invasive and can sometimes be painful for an individual to wear over an extended period. Subcutaneous and dermal analyte sensors can often be less painful for an individual to wear and can provide sufficient measurement accuracy in many cases.

The active portion of an analyte sensor may enter an individual's body through a skin penetration (e.g., transcutaneously) or other tissue penetration, with one or more additional sensor components remaining external to the individual's body. An introducer, particularly a needle or similar sharp, may be used to facilitate insertion of a subcutaneous or dermal analyte sensor into an individual's skin. The needle or similar sharp may make an initial penetration into the dermal layer of the skin, through which the analyte sensor may be subsequently inserted. For manufacturing reasons, discussed hereinafter, relatively large gauge needles or sharps may be used to facilitate insertion of an analyte sensor into a tissue. Needles having smaller diameters, such as acupuncture needles, may also be satisfactorily used, however. Smaller diameter needles may be particularly desirable for reducing tissue trauma at the site of sensor insertion, thereby increasing comfort for a wearer. Decreased tissue trauma may also limit the occurrence of erroneous or altered sensor readings in some instances.

Despite their desirability for promoting user comfort and potentially improving sensor performance, there is a significant manufacturing shortcoming associated with the use of acupuncture needles at present. Larger gauge needles or similar sharps may be manufactured with the needles or sharps held in highly oriented arrays and fixed in a defined configuration with respect to each other. The defined configuration of larger gauge needles may facilitate their incorporation into high-throughput manufacturing processes, particularly automated processes employing reel-to-reel production techniques. Acupuncture needles, in contrast, are commercially packaged in bulk in a randomized orientation. Although acupuncture needles may be incorporated into an inserter for an analyte sensor by manual 'pick and place' techniques, such approaches may considerably slow manufacturing throughput since they take place at the stage of assembling the finished sensor device. Accordingly, incorporating acupuncture needles in analyte sensor inserters currently presents economic and manufacturing challenges that may supersede the otherwise desirable benefits of employing acupuncture needles for insertion of an analyte sensor.

<CIT> describes an acupuncture needle pressing point type clamp and use method in the acupuncture needle film coating technology. <CIT> describes a suspended type plastic-handle acupuncture tube needle. <CIT> describes a disposable acupuncture tube needle.

The following figures are included to illustrate certain aspects of the present disclosure, and should not be viewed as exclusive embodiments. The subject matter disclosed is capable of considerable modifications, alterations, combinations, and equivalents in form and function, without departing from the scope of this disclosure.

In accordance with the present invention, there is provided a needle assembly and method of forming a needle construct according to the appended claims. The aspects and/or embodiments and/or examples disclosed in the following description but that are not covered by the appended claims are considered as not being part of the present invention and are disclosed by way of example only. The present disclosure generally describes analyte sensors suitable for in vivo use and, more specifically, oriented acupuncture needles and manufacturing methods associated therewith for use in conjunction with analyte sensors. Analyte sensor inserters incorporating an oriented acupuncture needle are also described herein.

As discussed above, utilization of an acupuncture needle for piercing tissue to facilitate insertion of an analyte sensor may be desirable. Use of an acupuncture needle may promote user comfort and decrease tissue trauma at the site of sensor insertion. Decreased tissue trauma may also advantageously improve sensor performance in certain cases. However, the randomized bulk packaging of acupuncture needles can complicate their utilization in certain high-throughput manufacturing processes. In particular, it can be difficult to orient as-obtained acupuncture needles in established high-throughput manufacturing processes for manufacturing an analyte sensor or analyte sensor inserter. As a result, substitution of acupuncture needles for larger gauge needles or similar sharps in certain high-throughput manufacturing processes may not be a straightforward matter. Nevertheless, the present disclosure demonstrates that pre-orientation of acupuncture needles in the manner disclosed herein may provide sufficient process compatibility to conduct high-throughput manufacturing. Namely, the present disclosure demonstrates that acupuncture needles may be preoriented in a batchwise manner prior to final assembly of a sensor device, and the oriented acupuncture needles may be satisfactorily incorporated in existing or modified of high-throughput manufacturing process for sensor assembly.

In various aspects, the present disclosure provides needle assemblies containing a plurality of acupuncture needles positioned in a pre-determined and highly oriented arrangement. Advantageously, acupuncture needles may be oriented with sufficient rapidity to support fabrication of the needle
assemblies in a high-throughput manner. Alternately, stockpiling of the oriented acupuncture needles may occur for feeding to a high-throughput manufacturing process. Moreover, individual needle constructs may be readily removed from the needle assemblies with the needle orientation being maintained, again in a high-throughput manner, such that acupuncture needles may be incorporated in analyte sensor inserters in a similar manner to that used for larger gauge needles and sharps and using minimally modified manufacturing lines. As such, the needle assemblies disclosed herein may facilitate high-throughput manufacturing of analyte sensor inserters incorporating an oriented acupuncture needle. Depending on various manufacturing considerations, the needle assemblies described herein may be fabricated in a separate production line from the analyte sensor inserters (potentially with stockpiling of the needle assemblies), or fabrication of the needle assemblies may be directly coupled as a separate operation of a process line for fabricating an analyte sensor inserter.

In some embodiments, the needle assemblies described herein may contain a plurality of acupuncture needles connected to a continuous support material via at least a first injection molded coupler. As used herein, the term "continuous support material" refers to a material whose length is much longer than its width, such as a material available in rolled form and having an aspect ratio of at least about <NUM>, at least about <NUM>, at least about <NUM>,<NUM>, or at least about <NUM>,<NUM>. Manufacturing processes employing a continuous support material may convey the continuous support material from a first reel to a second reel, with acupuncture needles becoming connected (coupled) to the continuous support material in between the first and second reels. A continuous support material may facilitate fabrication of the needle assemblies disclosed herein via high-throughput manufacturing methods. It is to be appreciated, however, that the needle assemblies and processes of the present disclosure may be alternately formed or conducted with support materials having finite dimensions, such that the needle assemblies are manufactured in shorter lengths (discrete units) as well.

More specifically, the needle assemblies and processes described herein feature acupuncture needles that are individually oriented within a plurality of apertures defined in a support material prior to an injection molding operation that connects the acupuncture needles to the support material. In some embodiments, orientation of the acupuncture needles within the needle assemblies may take place offline (prior to a manufacturing process incorporating an acupuncture needle in a sensor inserter) to provide a stockpile of oriented acupuncture needles. For example, robotic or manual 'pick and place' techniques may be used to provide an initial orientation of the acupuncture needles prior to forming the needle assemblies as described herein. Once the acupuncture needles have been connected to the support material with consistent orientation and spacing, further processing of the needle assemblies in a subsequent or contiguous production line may be readily conducted. As such, the present disclosure may facilitate high-throughput production of analyte sensors that are capable of insertion into a tissue of interest with minimal trauma, thereby allowing various user benefits to be realized.

Before describing the present needle assemblies and associated methods of production and use in further detail, a brief overview of suitable in vivo analyte sensors and analyte sensor applicators will be provided for further context of the disclosure herein. It is to be appreciated, however, that analyte sensors and analyte sensor applicator having different architectures and components other than those expressly described may be suitably used as well.

<FIG> shows a diagram of an illustrative analyte monitoring system that may incorporate an analyte sensor compatible with the disclosure herein. As shown, analyte monitoring system <NUM> includes sensor control device <NUM> and reader device <NUM> that are configured to communicate with one another over a local or remote communication path or link, which may be wired or wireless, uni- or bi-directional, and encrypted or non-encrypted. Reader device <NUM> may be a multipurpose smartphone or a dedicated electronic reader instrument. While only one reader device <NUM> is shown, more than one reader device <NUM> may be present in certain instances. Multiple reader devices <NUM> may be in communication with one another (e.g., to share and synchronize data). Reader device <NUM> may also be in communication with remote terminal <NUM> and/or trusted computer system <NUM> via communication path(s)/link(s) <NUM> and/or <NUM>, respectively, which also may be wired or wireless, uni- or bi-directional, and encrypted or non-encrypted. Reader device <NUM> may also be in communication with network <NUM> (e.g., a mobile telephone network, the internet, or a cloud server) via communication path/link <NUM>. Network <NUM> may be further communicatively coupled to remote terminal <NUM> via communication path/link <NUM> and/or trusted computer system <NUM> via communication path/link <NUM>. Remote terminal <NUM> and/or trusted computer system <NUM>, in turn, may communicate with network <NUM>, in some embodiments. Alternately, sensor control device <NUM> may communicate directly with remote terminal <NUM> and/or trusted computer system <NUM> without an intervening reader device <NUM> being present. For example, sensor control device <NUM> may communicate with remote terminal <NUM> and/or trusted computer system <NUM> through a direct communication link to network <NUM>, according to some embodiments, as described in <CIT>. Any suitable electronic communication protocol may be used for each of the local communication paths or links such as near field communication (NFC), radio frequency identification (RFID), BLUETOOTH® or BLUETOOTH® Low Energy protocols, WiFi, or the like. Remote terminal <NUM> and/or trusted computer system <NUM> may be accessible, according to some embodiments, by individuals other than a primary user. Reader device <NUM> may comprise display <NUM> and optional input component <NUM>. Display <NUM> may comprise a touch-screen interface, according to some embodiments.

Sensor control device <NUM> includes sensor housing <NUM>, which may include circuitry and a power source for operating sensor <NUM>. Optionally, the power source and/or active circuitry may be omitted. Sensor <NUM> may comprise a sensor tail (active portion) having sufficient length for insertion at a desired depth into a tissue of interest, such as the dermal layer of the skin. The sensor tail may comprise a sensing region that is active for sensing, and may comprise an enzyme and/or a redox mediator, according to one or more embodiments. A polymeric membrane (mass transport limiting layer) may be disposed upon the sensor tail, or the whole sensor, to aid in regulating flux of an analyte of interest, according to some embodiments.

One or more analyte levels may be determined using sensor <NUM> and undergo communication to reader device <NUM>. The analyte may be monitored in any biological fluid such as dermal fluid, plasma, blood, lymph, or the like. Analytes that may be monitored are not considered to be particularly limited. In certain embodiments, the analyte may be glucose. Other analytes of interest with respect to human physiology may include, for example, lactate, oxygen, pH, A1c, ketones, drug levels, and the like. Both single analytes and combinations of analytes may be assayed.

Sensor <NUM> extends adjacent to needle <NUM> in the configuration shown in <FIG>. Needle <NUM> is present transiently just prior to insertion of sensor <NUM> into a tissue and is withdrawn thereafter. While present, needle <NUM> may facilitate insertion of sensor <NUM> into a tissue of interest by opening an access pathway for sensor <NUM> to follow. For example, needle <NUM> may facilitate penetration of the epidermis as an access pathway to the dermis to allow implantation of sensor <NUM> to take place, according to one or more embodiments. In illustrative embodiments, needle <NUM> may be solid or hollow, beveled or non-beveled, and/or circular or non-circular in cross-section. Once the sensor <NUM> has been inserted into a tissue, the needle <NUM> is withdrawn, removed, and no longer deployed or associated with sensor housing <NUM>. That is, the needle is pulled back or otherwise retracted into the analyte sensor inserter <NUM>.

In the configuration depicted in <FIG>, a tip of needle <NUM> is angled over the terminus of sensor <NUM>, such that needle <NUM> penetrates a tissue first and opens an access pathway for sensor <NUM>. In alternative embodiments, the body of needle <NUM> may be angled with respect to sensor <NUM>, such that needle <NUM> again penetrates a tissue of interest in advance of sensor <NUM>. Angled configurations for needle <NUM> are described in further detail in commonly owned <CIT>. In still other alternative embodiments, sensor <NUM> may reside within a lumen or groove of needle <NUM>, with needle <NUM> similarly opening an access pathway for sensor <NUM> to follow. Regardless of configuration, once sensor <NUM> has been inserted into a tissue of interest, needle <NUM> may be retracted from the tissue and into an analyte sensor inserter (not shown in <FIG>) so to that the risk of sharps exposure is minimized.

Sensors <NUM> compatible with analyte monitoring system <NUM> may comprise two-electrode or three-electrode detection motifs, according to various embodiments. Three-electrode detection motifs may comprise a working electrode, a counter electrode, and a reference electrode. Two-electrode detection motifs may comprise a working electrode and a second electrode, in which the second electrode functions as both a counter electrode and a reference electrode (i.e., a counter/reference electrode). In both two-electrode and three-electrode detection motifs, the active portion of analyte sensor <NUM> may be in contact with the working electrode. The various electrodes may be at least partially stacked upon one another or laterally spaced apart, with a dielectric separator being positioned in between. A mass transport or biocompatibilizing membrane may overcoat at least some of the electrodes, or the whole sensor, according to some embodiments of the present disclosure.

It is to be recognized that analyte monitoring system <NUM> may comprise additional features and functionality that are not necessarily described herein in the interest of brevity. Accordingly, the foregoing description of analyte monitoring system <NUM> should be considered illustrative and non-limiting in nature.

Sensor <NUM> may be inserted in a tissue of interest using an analyte sensor inserter that is further operable to position sensor housing <NUM> upon the tissue surface, such as upon a surface of the skin. Illustrative analyte sensor inserters operable for positioning a sensor housing upon a skin surface are described in further detail in commonly owned <CIT> and <CIT> and commonly owned <CIT>. <FIG> shows a diagram of a portion of illustrative analyte sensor inserter <NUM>, in which needle <NUM> extends normally from needle holder <NUM> and promotes insertion of a dermal sensor, as described in greater detail in <CIT>. As shown hereinafter, needle constructs similar in structure to needle holder <NUM> may be produced according to the disclosure herein.

Accordingly, needle assemblies and needle constructs of the present disclosure are described in further detail hereinafter and with further reference to the drawings. The needle assemblies and needle constructs described herein may be incorporated in an insertion device for an analyte sensor, also referred to herein as an analyte sensor inserter, according to various embodiments.

In various embodiments, needle assemblies of the present disclosure may comprise: a support material having a plurality of apertures defined therein, and a first injection molded coupler located within each aperture that surrounds a proximal portion of an acupuncture needle and connects the acupuncture needle to a first location upon the support material. The acupuncture needle is held in a pre-determined orientation with respect to a longitudinal axis of the first injection molded coupler. As used herein, the term "distal portion" refers to a location upon the shaft of an acupuncture needle that is nearer to the sharpened tip (i.e., the insertion tip), and the term "proximal portion" refers to a location upon the shaft of an acupuncture needle that is nearer to the end opposite the insertion tip. As used herein, the term "distal portion" includes a segment of the acupuncture needle that includes at least the insertion tip, and the term "proximal portion" includes a segment of the acupuncture needle that includes the end opposite the insertion tip.

Acupuncture needles suitable for use in the present disclosure are not considered to be particularly limited in size or length, unless otherwise indicated herein. In more specific embodiments, acupuncture needles suitable for use in the disclosure herein may range between about <NUM> and about <NUM> in diameter, or between about <NUM> and about <NUM> in diameter, or between about <NUM> and about <NUM> in diameter, including any value or sub-range therebetween.

According to more specific embodiments, each acupuncture needle within the needle assemblies may be held in substantially the same orientation, within manufacturing tolerances. In some or other more specific embodiments, the acupuncture needles in adjacent apertures may be spaced apart from one another substantially uniformly, within manufacturing tolerances. Angular deviation (variance) between the plurality of acupuncture needles in the needle assemblies may be about <NUM> degree or less, or about <NUM> degrees of less, or about <NUM> degrees or less. According to various embodiments, the pitch (spacing between adjacent acupuncture needles) may be about <NUM> or less, or about <NUM> or less, or about <NUM> or less, or about <NUM> or less, or about <NUM> or less, with a pitch variance of about <NUM> or less. In more specific embodiments, the pitch may constitute a spacing between about <NUM> and about <NUM>, with a pitch variance of about <NUM> or less. In some or other embodiments, the length of the acupuncture needles may be about <NUM> or less, or about <NUM> or less, or about <NUM> or less, or about <NUM> or less, or about <NUM> or less, with a length variance of about <NUM> or less. In more specific embodiments, the length of the acupuncture needles may range between about <NUM> and about <NUM>, or between about <NUM> and about <NUM>, with a length variance of about <NUM> or less.

According to some embodiments, the acupuncture needle within each aperture may be held non-parallel with respect to the longitudinal axis of the first injection molded coupler. In more specific embodiments, the acupuncture needle within each aperture may be held at an angle ranging between about <NUM>° and about <NUM>°, or between about <NUM>° and about <NUM>° or between about <NUM>° and about <NUM>° with respect to the longitudinal axis, including any value or sub-range therebetween. By angling the acupuncture needle, the skin may stretch to one side when making a skin penetration, which creates a gap for promoting easier sensor insertion. In still more specific embodiments, the acupuncture needle within each aperture may be held at an angle ranging between about <NUM>° and about <NUM>° with respect to the longitudinal axis, including any value or sub-range therebetween.

In certain embodiments, the needle assemblies described herein may further comprise a second injection molded coupler located within each aperture that surrounds a distal portion of the acupuncture needle and connects the acupuncture needle to a second location upon the support material. The second injection molded coupler may aid in protecting the insertion tip of the acupuncture needle during fabrication of the needle assemblies described herein, thereby potentially lowering the fraction of units rejected for quality control defects during subsequent analyte sensor inserter fabrication. Moreover, the second injection molded coupler may further stabilize the acupuncture needle within each aperture by limiting flexural motion during fabrication of the needle assemblies. Alternately, a second injection molded piece may surround a distal portion of the acupuncture needle but remain unattached (no coupling) to the support material. Such configurations may similarly aid in protecting the insertion tip of the acupuncture needle.

<FIG> shows a diagram of a portion of a needle assembly of the present disclosure having a plurality of acupuncture needles affixed in a pre-determined orientation. As shown in <FIG>, needle assembly <NUM> is formed upon continuous support material <NUM>. Continuous support material <NUM> may be a continuous metal tape, strip or film, although alternative materials and forms capable of being processed in a reel-to-reel manner may also be used in some cases. In some embodiments, stainless steel may be a suitable metal upon which needle assembly <NUM> may be fabricated. Other suitable tapes may include alternative metals or other materials that are able to withstand the injection molding temperatures needed to fabricate needle assembly <NUM>. In alternative embodiments, needle assembly <NUM> may be formed upon a support material having finite length, such that assembly fabrication takes place in discrete units rather than by reel-to-reel continuous processing.

Apertures <NUM> are defined in the plane of continuous support material <NUM>, such as through a die-cutting or stamping process, for example. Formation of apertures <NUM> may take place in conjunction with or prior to the process for fabricating needle assembly <NUM>, or apertures <NUM> may be present in as-obtained continuous support material <NUM>.

Acupuncture needles <NUM> are affixed to continuous support material <NUM> in at least one location and may be arranged in-plane in each aperture <NUM>. At least proximal portion 306a of each acupuncture needle <NUM> is surrounded by first injection molded coupler <NUM>, which adjoins proximal portion 306a to continuous support material <NUM> via neck <NUM>. Each neck <NUM> may extend from continuous support material <NUM> into each aperture <NUM>, such that first injection molded coupler <NUM> surrounds neck <NUM>. According to more specific embodiments, neck <NUM> may be coincident with longitudinal axis A of first injection molded coupler <NUM>. As depicted in <FIG>, neck <NUM> terminates within the interior of first injection molded coupler <NUM>. The size and shape of first injection molded coupler <NUM> may be selected to facilitate its incorporation into an analyte sensor inserter (see <FIG>), as discussed in further detail herein. It is to be appreciated that the particular size and/or shape of first injection molded coupler <NUM> is not especially limited.

In some embodiments, first injected molded coupler <NUM> may comprise leg <NUM> that is radially offset from longitudinal axis A. Proximal portion 306a of acupuncture needle <NUM> may be surrounded by leg <NUM>, and distal portion 306b of acupuncture needle <NUM> may protrude into aperture <NUM> and beyond. Specifically, distal portion 306b may extend from leg <NUM> at a non-zero angle with respect to longitudinal axis A, according to certain embodiments. In addition to serving as an attachment point for acupuncture needle <NUM>, leg <NUM> may serve as a 'keying feature' to facilitate proper orientation in an analyte sensor inserter. Although <FIG> has shown first injection molded coupler <NUM> as containing one leg <NUM>, it is to be appreciated that multiple legs <NUM> may be present in alternative embodiments. Multiple legs <NUM> may provide additional keying features to facilitate assembly of an analyte sensor inserter. When multiple legs <NUM> are present, distal portion 306b of acupuncture needle <NUM> may extend from one leg <NUM>, whereas the remainder of legs <NUM> do not contact acupuncture needle <NUM> or an additional acupuncture needle.

First injection molded coupler <NUM> and acupuncture needle <NUM> may be adapted to remain connected together with one another once individual acupuncture needles <NUM> are separated as needle constructs from needle assembly <NUM>, as discussed in further detail below. To facilitate keeping acupuncture needle <NUM> connected together with first injection molded coupler <NUM>, proximal portion 306a of acupuncture needle <NUM> may be modified, according to some embodiments, to promote retention within first injection molded coupler <NUM>. Specifically, according to some embodiments, proximal portion 306a of acupuncture needle <NUM> may be bent, contain a pinch point, or any combination thereof to promote retention of acupuncture needle <NUM> within first injection molded coupler <NUM>. The bend or pinch point creates a physical barrier to needle pullout from first injection molded coupler <NUM>. <FIG> show expanded cross-sectional views of individual acupuncture needles <NUM> within needle assembly <NUM> (<FIG>), in which first injection molded coupler <NUM> includes acupuncture needle <NUM> with a proximal modification. Specifically, acupuncture needle <NUM> includes pinch point <NUM> within leg <NUM> in <FIG>, and in <FIG>, acupuncture needle <NUM> includes bend <NUM> within leg <NUM>.

A second connection location between acupuncture needle <NUM> and continuous support material <NUM> may be present in needle assembly <NUM>, according to some embodiments. Specifically, referring again to <FIG>, optional second injection molded coupler <NUM> may surround distal portion 306b of acupuncture needle <NUM> and connect acupuncture needle <NUM> to a second location <NUM> upon continuous support material <NUM>. Alternately, second injection molded coupler <NUM> may surround distal portion 306b without making a connection to continuous support material <NUM>, in which case second injection molded coupler <NUM> may instead be considered an injection molded piece. In the two-connection configuration depicted in <FIG>, second injection molded coupler <NUM> is disposed generally opposite neck <NUM> in aperture <NUM>. The position of second injection molded coupler <NUM> may be chosen such that the insertion tip of acupuncture needle <NUM> is surrounded following injection molding, thereby protecting the insertion tip from damage during manipulation of acupuncture needle <NUM>. Even when second injection molded coupler <NUM> is not connected to continuous support material <NUM>, the insertion tip of acupuncture needle <NUM> may still be protected. The shape of second injection molded coupler <NUM> is not considered to be particularly limited, and the depicted generally trapezoidal configuration should not be considered as limiting the scope of the present disclosure. According to more specific embodiments, second injection molded coupler <NUM> may be bisected by the plane of continuous support material <NUM> such that a first portion of second injection molded coupler <NUM> is formed on a first side of the plane and a second portion of second injection molded coupler <NUM> is formed on a second side of the plane.

Unlike first injection molded coupler <NUM>, second injection molded coupler <NUM> may be configured to establish a temporary connection between acupuncture needle <NUM> and continuous support material <NUM>. More specifically, acupuncture needle <NUM> is configured such that it can be easily removed from second injection molded coupler <NUM> at a desired time, thereby freeing the insertion tip to facilitate tissue penetration, such as for insertion of an analyte sensor, for example. According to various embodiments, acupuncture needle <NUM> may be tapered at distal portion 306b (e.g., adjacent to the insertion tip), such that release of acupuncture needle <NUM> from second injection molded coupler <NUM> may be affected by a light pulling action. In some embodiments, either separately or in combination with tapering of distal potion 306b, a non-stick material such as a silicone or polytetrafluoroethylene coating, for example, may be applied to acupuncture needle <NUM> to facilitate removal from second injection molded coupler <NUM>.

Various methods for fabricating and using the needle assemblies of the present disclosure are also contemplated herein. Methods for using the needle assemblies may include separating individual acupuncture needles arranged in a defined orientation within a needle construct and incorporating the oriented acupuncture needles into an analyte sensor inserter, as described in further detail below.

Methods for fabricating the needle assemblies of the present disclosure may comprise: providing a support material having a plurality of apertures defined therein, a neck extending from the support material into each aperture; arranging an acupuncture needle within each aperture; and injection molding polymeric material to form a first injection molded coupler that surrounds both the neck and a proximal portion of the acupuncture needle within each aperture, thereby connecting the acupuncture needle to a first location upon the support material via the neck. The needle assemblies may be fabricated such that the neck is coincident with a longitudinal axis of the first injection molded coupler, and such that the acupuncture needle is held in a pre-determined orientation with respect to the longitudinal axis, such as shown above in <FIG>.

In more specific embodiments, the support material may comprise a continuous support material, such as a continuous metal tape.

According to some further embodiments, methods for fabricating needle assemblies of the present disclosure may further comprise injection molding polymeric material to form a second injection molded coupler that surrounds a distal portion of the acupuncture needle within each aperture and connects the acupuncture needle to a second location upon the support material. Alternately, a second injection molded coupler (injection molded piece) surrounding a distal portion of the acupuncture needle within each aperture may be fabricated similarly, but without making a connection to the support material.

Injection molding processes suitable for forming the first and second injection molded couplers will be familiar to one having ordinary skill in the art. Such processes may comprise placing one or more molds within each aperture, and injecting polymeric material into the mold(s) to form the first injection molded coupler and optionally the second injection molded coupler, wherein each injection molded coupler is positioned as described above. The first and second injection molded couplers may be formed in the same injection molding process or in separate injection molding processes. Moreover, the polymeric material used for forming the first injection molded coupler and the second injection molded coupler may be the same or different. Any suitable thermoplastic or thermosetting polymeric material may be used to form the first and second injection molded couplers. For example, in some embodiments, the first injection molded coupler may be formed from a rigid polymeric material that may facilitate use of a needle construct in an analyte sensor inserter, and the second injection molded coupler may be formed from a compliant polymeric material that may facilitate needle withdrawal at a desired time. The injection molding processes may further comprise placing an acupuncture needle within each mold prior to injecting polymeric material thereto. In some embodiments, manual or automated pick and place techniques may be used for positioning the acupuncture needle within the mold(s).

Methods for fabricating the needle assemblies of the present disclosure may further comprise, in some embodiments, die-cutting or stamping the support material to define the plurality of apertures. The apertures may be of a desired size and shape to contain the acupuncture needle and at least the first injection molded coupler. Suitable die-cutting or stamping processes will be familiar to one having ordinary skill in the art. The die-cutting or stamping process may be conducted integrally with the injection molding process(es) or in a separate production line before the injection molding process(es). In other embodiments, the support material may be obtained, sourced, or purchased with a plurality of apertures already being defined therein.

<FIG> show diagrams illustrating an exemplary process whereby a first configuration of needle assemblies of the present disclosure may be fabricated. In the interest of clarity, <FIG> show needle assembly fabrication taking place in two apertures, but it is to be appreciated that the depicted concepts may be extended to fabrication taking place in more than two apertures of a support material, either simultaneously or non-simultaneously (consecutively).

In <FIG>, continuous metal tape <NUM> having a plurality of apertures <NUM> of defined shape is obtained/provided (e.g., as a pre-punched tape from a commercial source) or formed (e.g., by stamping or die-cutting) prior to fabricating a needle assembly. Neck <NUM> extends as an elongate member into each aperture <NUM>.

Next, as shown in <FIG>, mold <NUM>, having acupuncture needle <NUM> positioned internally therein, is arranged within each aperture <NUM> in preparation for injection molding. Further details concerning mold <NUM> and positioning of acupuncture needle <NUM> therein are provided below in reference to <FIG>. Neck <NUM> extends into mold <NUM> so that a connection between continuous metal tape <NUM> and acupuncture needle <NUM> occurs upon injection molding. A second connection between continuous metal tape <NUM> and acupuncture needle <NUM> may also be present distally upon acupuncture needle <NUM> as well.

<FIG> shows the next stage in the process for fabricating needle assembly <NUM>, in which the injection molding operation(s) have been completed and mold <NUM> has been removed from each aperture <NUM>. Following the injection molding operation(s), acupuncture needle <NUM> is connected to continuous metal tape <NUM> at neck <NUM> via first injection molded coupler <NUM> and optionally via second injection molded coupler <NUM> at the bottom of aperture <NUM>. Second injection molded coupler <NUM> is removably connected to acupuncture needle <NUM>, as described above, to aid in protecting the insertion tip during assembly fabrication and needle manipulation.

Although <FIG> has shown acupuncture needle <NUM> being contained in a single mold <NUM> for forming first and second injection molded couplers <NUM> and <NUM>, an alternative approach may utilize second mold <NUM> for forming second injection molded coupler <NUM> around distal portion <NUM>, without departing from the scope of the present disclosure, such as that shown in <FIG>.

Alternately, distal portion <NUM> of acupuncture needle <NUM> may reside outside mold <NUM> and remain unsupported throughout the injection molding process. <FIG> show diagrams illustrating an exemplary process whereby a second configuration of needle assemblies of the present disclosure may be fabricated. Namely, needle assembly <NUM>, depicted in <FIG>, lacks a second injection molded coupler <NUM>, such that acupuncture needle <NUM> is only supported within first injection molded coupler <NUM> and thereby connected to continuous metal tape <NUM>. Other than the disposition of acupuncture needle <NUM> within mold <NUM>, the operations shown in <FIG> are similar to those shown in <FIG> and will accordingly not be described in detail again.

Each mold <NUM> has shape complementarity with each aperture <NUM>, such that mold <NUM> fits therein and overlays one or more desired portions of continuous metal tape <NUM>. When second mold <NUM> is used for forming second injection molded coupler <NUM>, it may similarly overlay a bottom portion of continuous metal tape <NUM>. According to some embodiments, mold <NUM> may be a two-piece mold to facilitate loading of acupuncture needle <NUM> therein. In such embodiments, a first piece of mold <NUM> is positioned adjacent to a first side of continuous metal tape <NUM>, and a second piece of mold <NUM> is positioned adjacent to a second side of continuous metal tape <NUM>. One or more cavities may be defined between the two pieces, as explained below in reference to <FIG>. The one or more cavities may be bisected by the plane of continuous metal tape <NUM>. Neck <NUM> may extend into at least one of the cavities such that injection molding forms a connection between acupuncture needle <NUM> and neck <NUM>. Although mold <NUM> may be a two-piece mold to facilitate loading of acupuncture needle <NUM>, it is to be appreciated that mold <NUM> may be a one-piece mold in some alternative embodiments.

<FIG> show illustrative diagrams of mold <NUM> arranged within aperture <NUM>, in which a single piece (hemisphere) of mold <NUM> has been shown in order to display the internal details of mold <NUM> and the positioning of acupuncture needle <NUM> therein. As previously shown in <FIG>, the two pieces (hemispheres) of mold <NUM> may be assembled together in aperture <NUM> in preparation for injection molding.

Referring to <FIG>, mold <NUM> contains cavities <NUM> and <NUM> therein. Cavities <NUM> and <NUM> may be filled with a thermoplastic or thermosetting material during a single injection molding process or separately during two or more injection molding processes to define first injection molded coupler <NUM> (<FIG>) and second injection molded coupler <NUM> (<FIG>), respectively. Neck <NUM> extends into cavity <NUM>, such that first injection molded coupler <NUM> (<FIG>) is formed in cavity <NUM> and surrounds neck <NUM>. Second injection molded coupler <NUM> (<FIG>) is formed in cavity <NUM>. Cavity <NUM> overlays a corresponding notch in continuous metal tape <NUM> at the bottom of aperture <NUM>, such that a first portion of second injection molded coupler <NUM> (<FIG>) overlays the notch and a second portion is formed upon continuous metal tape <NUM>. Alternately, second injection molded coupler <NUM> (injection molded piece) may surround distal portion 510b of acupuncture needle <NUM> but not form a connection to continuous metal tape <NUM>.

Needle channel <NUM> extends between cavity <NUM> and cavity <NUM>. Needle channel <NUM> is sized to receive acupuncture needle <NUM>, as shown in <FIG>, such that proximal portion 510a of acupuncture needle <NUM> extends into cavity <NUM> and distal portion 510b of acupuncture needle <NUM> extends into cavity <NUM>. Once injection molding has taken place to form first injection molded coupler <NUM> (<FIG>) and second injection molded coupler <NUM> (<FIG>), acupuncture needle <NUM> is connected to continuous metal tape <NUM> both distally and proximally and held in a pre-determined orientation for further manipulation. Needle channel <NUM> is generally not filled with thermoplastic or thermosetting material during the injection molding operation(s).

As discussed above, distal portion 510b of acupuncture needle <NUM> may also be unsupported, as shown for needle assembly <NUM> in <FIG>. A mold omitting needle channel <NUM> and cavity <NUM> may be used when forming needle assembly <NUM> with acupuncture needle <NUM> having an unsupported distal portion 510b. <FIG> shows an illustrative configuration for mold <NUM> that is suitable for forming needle assembly <NUM> having distal portion 510b of acupuncture needle <NUM> in an unsupported state.

Once injection molding is complete and each mold <NUM> has been removed, needle assembly <NUM> (<FIG>) or <NUM> (<FIG>) may be stored for further use or fed directly into a process for fabricating an analyte sensor inserter, such as that shown in <FIG>. In either case, the position of each acupuncture needle <NUM> remains fixed with respect to first injection molded coupler <NUM> until further needle manipulation takes place, as described hereinbelow. In addition, the separation and orientation of each acupuncture needle <NUM> remains fixed with respect to one another, also facilitating further needle manipulations. In more specific embodiments, each acupuncture needle <NUM> may be spaced apart substantially uniformly. Since needle assembly <NUM> or <NUM> provides a highly ordered and regular arrangement of multiple acupuncture needles <NUM>, they may be manipulated in a manner similar to that of conventional arrays of larger gauge needles or similar sharps. As such, the needle assemblies of the present disclosure may facilitate various manufacturing processes using only minor modifications of existing production lines, as described hereinafter. Namely, the needle assemblies of the present disclosure may directly replace an array of larger gauge needles or similar sharps used in present manufacturing processes.

Prior to incorporation in an analyte sensor inserter or other type of device, individual acupuncture needles <NUM> are removed from needle assembly <NUM> in the form of a needle construct. The needle construct comprises acupuncture needle <NUM> and first injection molded coupler <NUM>, wherein acupuncture needle <NUM> remains held in a pre-determined orientation with respect to the longitudinal axis of first injection molded coupler <NUM>, particularly non-parallel orientations with respect to the longitudinal axis. Operations to affect removal of individual needle constructs are described below in reference to <FIG>. Removal of individual needle constructs may take place as a further operation of forming needle assembly <NUM> or as an entirely separate process, according to various embodiments.

Accordingly, in further embodiments, methods of the present disclosure may comprise separating a needle construct from the support material, such as a continuous metal tape, and the second injection molded coupler, if present, and incorporating the needle construct into an insertion device for an analyte sensor or another type of device. The needle construct comprises an acupuncture needle and the first injection molded coupler, wherein the first injection molded coupler surrounds a proximal portion of the acupuncture needle. In some embodiments, the proximal portion of the acupuncture needle may comprise a pinch point, bend, or any combination thereof to promote retention in the first injection molded coupler.

In further embodiments, separating the needle construct may comprise severing the neck adjacent to the first injection molded coupler, and pulling the distal end of the acupuncture needle from the second injection molded coupler. In embodiments wherein the second injection molded coupler is not present, severing the neck adjacent to the first injection molded coupler directly releases the needle construct from the needle assembly. Severing the neck to release the needle construct leaves a metal core within the first injection molded coupler, wherein the metal core may be coincident with the longitudinal axis of the first injection molded coupler. Once separated from the needle assembly, the individual needle constructs may be further manipulated into a production line.

As shown in <FIG>, neck <NUM> may be severed to break the first connection to continuous metal tape <NUM>. Severing of neck <NUM> may take place using any suitable method, such as guillotine cutting, die cutting, scissor cutting, or the like. Once neck <NUM> has been severed, first injection molded coupler <NUM> and acupuncture needle <NUM> are free to move together along longitudinal axis A. Application of a gentle axial pulling force F (shown with block arrow) along longitudinal axis A may be sufficient to dislodge acupuncture needle <NUM> from second injection molded coupler <NUM>, thereby freeing needle construct <NUM> (<FIG>). Similar operations may be used to separate needle construct <NUM> in embodiments either lacking second injection molded coupler <NUM> or having second injection molded coupler <NUM> that is unconnected to metal tape <NUM>, such as in needle assembly <NUM>. Needle construct <NUM> includes acupuncture needle <NUM> held in a defined configuration with respect to first injection molded coupler <NUM>, as discussed herein.

Embodiments disclosed herein, which may fall within the scope of the invention, which is as defined in the appended claims, include:.

Each of embodiments A and B may have one or more of the following additional elements in any combination.

Element <NUM>: wherein the support material comprises a continuous metal tape.

Element <NUM>: wherein a neck extends from the support material into each aperture; wherein the first injection molded coupler surrounds the neck, such that the neck is coincident with the longitudinal axis.

Element <NUM>: wherein the needle assembly further comprises: a second injection molded coupler located within each aperture that surrounds a distal portion of the acupuncture needle and connects the acupuncture needle to a second location upon the support material.

Element <NUM>: wherein the proximal portion of the acupuncture needle is bent, contains a pinch point, or any combination thereof.

Element <NUM>: wherein the first injection molded coupler comprises a leg that is radially offset from the longitudinal axis; wherein the proximal portion of the acupuncture needle is surrounded by the leg and a distal portion of the acupuncture needle extends from the leg at a non-zero angle with respect to the longitudinal axis.

Element <NUM>: wherein the support material comprises a continuous metal tape, a neck extends from the continuous metal tape into each aperture, and the first injection molded coupler surrounds the neck, such that the neck is coincident with the longitudinal axis.

Element <NUM>: wherein the acupuncture needle ranges between about <NUM> and about <NUM> in diameter.

Element <NUM>: wherein acupuncture needles in adjacent apertures are spaced apart substantially uniformly.

Element <NUM>: wherein separating the needle construct comprises severing the neck adjacent to the first injection molded coupler.

Element <NUM>: wherein the needle assembly further comprises: an injection molded piece located within each aperture that surrounds a distal portion of the acupuncture needle.

By way of non-limiting example, exemplary combinations applicable to A, B, and C, which fall within the scope of the invention as defined by the appended claims, include: The needle assembly of A in combination with elements <NUM>; <NUM>; <NUM> and <NUM>; <NUM>; <NUM>; <NUM>; <NUM>; <NUM>; <NUM>; and <NUM>. The method of B in combination with element <NUM>.

Unless otherwise indicated, all numbers expressing quantities and the like in the present specification and associated claims are to be understood as being modified in all instances by the term "about. " Accordingly, unless indicated to the contrary, the numerical parameters set forth in the following specification and attached claims are approximations that may vary depending upon the desired properties sought to be obtained by the embodiments of the present disclosure. At the very least, and not as an attempt to limit the application of the doctrine of equivalents to the scope of the claim, each numerical parameter should at least be construed in light of the number of reported significant digits and by applying ordinary rounding techniques.

One or more illustrative embodiments incorporating various features are presented herein. Not all features of a physical implementation are described or shown in this application for the sake of clarity. It is understood that in the development of a physical embodiment incorporating the embodiments of the present disclosure, numerous implementation-specific decisions must be made to achieve the developer's goals, such as compliance with system-related, business-related, government-related and other constraints, which vary by implementation and from time to time. While a developer's efforts might be time-consuming, such efforts would be, nevertheless, a routine undertaking for those of ordinary skill in the art and having benefit of this disclosure.

While various systems, tools and methods are described herein in terms of "comprising" various components or steps, the systems, tools and methods can also "consist essentially of" or "consist of" the various components and steps.

As used herein, the phrase "at least one of" preceding a series of items, with the terms "and" or "or" to separate any of the items, modifies the list as a whole, rather than each member of the list (i.e., each item). The phrase "at least one of" allows a meaning that includes at least one of any one of the items, and/or at least one of any combination of the items, and/or at least one of each of the items.

Claim 1:
A needle assembly (<NUM>) comprising:
a support material (<NUM>) having a plurality of apertures (<NUM>) defined therein; and
a first injection molded coupler (<NUM>), located within each aperture, that surrounds a proximal portion of an acupuncture needle and connects the acupuncture needle to a first location upon the support material;
wherein the acupuncture needle (<NUM>) is held in a pre-determined orientation with respect to a longitudinal axis of the first injection molded coupler,
wherein a portion of the acupuncture needle extending from the first injection molded coupler is held non-parallel with respect to the longitudinal axis of the first injection molded coupler.