Insertion tool

Abstract

To provide a needle assembly containing oriented acupuncture needles.SOLUTION: Acupuncture needles may be used for piercing tissue with less trauma than may occur when employing larger gauge needles. However, because acupuncture needles are fabricated and packaged differently than are larger gauge needles, acupuncture needles may be less compatible with certain manufacturing processes. Needle assemblies compatible with manufacturing processes may comprise a continuous support material having a plurality of apertures defined therein, and a first injection molded coupler that surrounds a proximal portion of an acupuncture needle and connects the acupuncture needle to a first location upon the continuous support material, such that the acupuncture needle is held in a pre-determined orientation with respect to a longitudinal axis of the first injection molded coupler. The acupuncture needles in adjacent apertures may also be spaced apart substantially uniformly.SELECTED DRAWING: Figure 3

Description

[Background technology]

[0001] Detecting various analytes in an individual's body can be essential for monitoring health conditions. Deviations from normal values ​​of analytes can often be indicative of many physiological conditions. For example, blood glucose levels are particularly important for detecting and monitoring diabetic patients. By monitoring blood glucose levels regularly enough, a diabetic patient may be able to take corrective action (e.g., by injecting insulin to lower blood glucose levels or by eating to raise blood glucose levels) before significant physiological harm occurs. Other analytes under the influence of physiological dysregulation that are also desirable to monitor include, but are not limited to, lactate, oxygen, pH, A1c, ketones, drug concentrations, etc.

[0002] Analyte monitoring of an individual may occur periodically or continuously over a period of time. Periodic analyte monitoring may be performed by taking samples of bodily fluids, such as blood, at various time intervals and analyzing them outside the body. Continuous analyte monitoring may be performed using one or more sensors that remain at least partially implanted within the individual's tissue, such as cutaneously, subcutaneously, or intravenously, such that analysis may be performed inside the body. The implanted sensors may collect analyte data continuously or sporadically (usually periodically), depending on the individual's particular health needs and / or previously measured analyte values.

[0003] Periodic in vitro analyte monitoring may be sufficient to measure the physiological state of many individuals. However, in vitro analyte monitoring may be inconvenient or painful for some individuals. Furthermore, if measurements are not taken at the appropriate time, there is no way to recover lost data.

[0004] Continuous analyte monitoring with an implanted sensor may be a more desirable approach for individuals with severe analyte dysregulation and / or rapidly fluctuating analyte values, but may also be beneficial for other individuals. Although continuous analyte monitoring with an implanted sensor may be advantageous, there are challenges associated with this type of measurement. Intravenous analyte sensors have the advantage of providing analyte concentrations directly from the blood, but are invasive and can be painful for an individual to wear for extended periods of time. Subcutaneous and cutaneous analyte sensors are often less painful for an individual to wear and can often provide sufficient measurement accuracy.

[0005] The active portion of the analyte sensor may enter the individual's body through skin penetration (e.g., transdermal) or other tissue penetration, with one or more additional sensor components remaining outside the individual's body. To facilitate the insertion of a subcutaneous or cutaneous analyte sensor into the individual's skin, an introducer, particularly a needle or similar sharp, may be used. The needle or similar sharp may first penetrate the dermis layer of the skin, through which the analyte sensor may subsequently be inserted. To facilitate the insertion of the analyte sensor into tissue, for manufacturing reasons described below, a relatively large gauge needle or sharp may be used. However, needles having a smaller diameter, such as acupuncture needles, may also be used satisfactorily. A smaller diameter needle may be particularly desirable to reduce tissue trauma at the sensor insertion site, thereby increasing wearer comfort. Reduced tissue trauma may, in some cases, limit the occurrence of erroneous or altered sensor readings.

[0006] Despite the desirability of promoting user comfort and potentially improving sensor performance, there are currently significant manufacturing drawbacks associated with the use of acupuncture needles. 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 relative to one another. The defined configuration of larger gauge needles may facilitate incorporation into high throughput manufacturing processes, especially automated processes employing reel-to-reel manufacturing techniques. In contrast, acupuncture needles are commercially packaged in large quantities with random orientations. Although acupuncture needles can be incorporated into analyte sensor inserters by manual "pick and place" techniques, such an approach is performed at the stage of assembling the completed sensor device, which can significantly reduce manufacturing throughput. Thus, incorporating acupuncture needles into analyte sensor inserters currently presents economic and manufacturing challenges that may supplant the desirable benefits of using acupuncture needles for analyte sensor insertion.

[0007] The following figures are for the purpose of illustrating certain aspects of the present disclosure, but should not be considered as exclusive embodiments. The disclosed subject matter is capable of considerable modification, permutations, combinations, and equivalents in form and function without departing from the scope of the present disclosure. [Brief description of the drawings]

[0008] [Figure 1] FIG. 1 shows a diagram of an exemplary analyte monitoring system that can incorporate analyte sensors compatible with the present disclosure. [Diagram 2] FIG. 2 shows a partial view of an exemplary analyte sensor inserter compatible with the present disclosure. [Diagram 3] FIG. 3 shows a view of a portion of a needle assembly of the present disclosure having multiple acupuncture needles attached in a predetermined orientation. [Figure 4A] FIG. 4A shows an enlarged cross-sectional view of the needle assembly of FIG. 3, in which a pinch point or bend is present at the proximal end of the acupuncture needle. [Figure 4B] FIG. 4B shows an enlarged cross-sectional view of the needle assembly of FIG. 3, in which a pinch point or bend is present at the proximal end of the acupuncture needle. [Figure 5A] FIG. 5A shows a diagram illustrating an exemplary process by which a first configuration of the needle assembly of the present disclosure may be manufactured. [Figure 5B] FIG. 5B shows a diagram illustrating an exemplary process by which the first configuration of the needle assembly of the present disclosure may be manufactured. [Figure 5C] FIG. 5C shows a diagram illustrating an exemplary process by which the first configuration of the needle assembly of the present disclosure may be manufactured. [Figure 5D] FIG. 5D shows a diagram illustrating an alternative injection molding process to that shown in FIG. 5B. [Figure 6A] FIG. 6A shows a diagram illustrating an exemplary process by which the second configuration of the needle assembly of the present disclosure may be manufactured. [Figure 6B] FIG. 6B shows a diagram illustrating an exemplary process by which the second configuration of the needle assembly of the present disclosure may be manufactured. [Figure 6C] FIG. 6C shows a diagram illustrating an exemplary process by which the second configuration of the needle assembly of the present disclosure may be manufactured. [Figure 7A] FIG. 7A shows an exemplary diagram of one hemisphere of a mold placed within an opening in a support material that may be used to form the needle assembly shown in FIG. 5C. [Figure 7B] FIG. 7B shows an exemplary diagram of one hemisphere of a mold placed within an opening in a support material that may be used to form the needle assembly shown in FIG. 5C. [Figure 7C] FIG. 7C shows an exemplary diagram of one hemisphere of a mold placed within an opening in a support material that may be used to form the needle assembly shown in FIG. 6C. [Figure 8A] FIG. 8A illustrates an exemplary process for removing a needle structure from a needle assembly. [Figure 8B]FIG. 8B shows an exemplary needle structure that does not include a support material. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0009] The present disclosure generally describes analyte sensors suitable for use within the body, and more specifically, oriented acupuncture needles for use in combination with the analyte sensors and related methods of manufacture. Also described herein are analyte sensor inserters incorporating the oriented acupuncture needles.

[0010] As mentioned above, the use of acupuncture needles to penetrate tissue to facilitate insertion of an analyte sensor may be desirable. The use of acupuncture needles may promote user comfort and reduce tissue trauma at the sensor insertion site. Also, reduced tissue trauma may advantageously improve sensor performance in certain cases. However, messy bulk acupuncture needle packaging may complicate utilization in certain high-throughput manufacturing processes. In particular, it may be difficult to orient as-obtained acupuncture needles in established high-throughput manufacturing processes for manufacturing analyte sensors or analyte sensor inserters. As a result, it is not straightforward to use acupuncture needles in place of larger gauge needles or similar sharps in certain high-throughput manufacturing processes. Nevertheless, the present disclosure demonstrates that pre-orientation of acupuncture needles in the manner disclosed herein may provide sufficient process compatibility to implement high-throughput manufacturing. That is, the present disclosure demonstrates that acupuncture needles may be pre-oriented in a batch manner prior to final assembly of the sensor device, and that the oriented acupuncture needles may be fully incorporated into existing or modified high-throughput manufacturing processes for sensor assembly.

[0011] In various aspects, the present disclosure provides a needle assembly including a plurality of acupuncture needles positioned in a predetermined highly oriented arrangement. Advantageously, the acupuncture needles can be oriented fast enough to support the manufacture of needle assemblies in a high-throughput manner. Alternatively, a stockpile of oriented acupuncture needles may be made to feed into a high-throughput manufacturing process. Furthermore, individual needle structures can be easily removed from the needle assembly with needle orientation maintained in a high-throughput manner, and the acupuncture needles can be assembled into analyte sensor inserters using minimally modified manufacturing lines in a manner similar to that used for larger gauge needles and sharps. Thus, the needle assemblies disclosed herein may facilitate high-throughput manufacturing of analyte sensor inserters incorporating oriented acupuncture needles. Depending on various manufacturing considerations, the needle assemblies described herein may be manufactured on a separate production line from the analyte sensor inserters (potentially with a stockpile of needle assemblies), or the manufacture of the needle assemblies may be combined as a separate operation of the processing line for manufacturing the analyte sensor inserters.

[0012] In some embodiments, the needle assemblies described herein may include a plurality of acupuncture needles connected to a continuous support material via at least a first injection molding coupler. As used herein, the term "continuous support material" refers to a material that is much longer in length than it is wide, e.g., available in rolled form and having an aspect ratio of at least about 10, at least about 100, at least about 1000, or at least about 10000. A manufacturing process using a continuous support material may carry the continuous support material from a first reel to a second reel, with the acupuncture needles connected (coupled) to the continuous support material between the first reel and the second reel. The continuous support material may facilitate the manufacture of the needle assemblies disclosed herein via high throughput manufacturing methods. However, it should be understood that the needle assemblies and processes disclosed herein may alternately be formed or performed with support materials having finite dimensions, and the needle assemblies may also be manufactured in shorter lengths (discrete units).

[0013] More specifically, the needle assemblies and processes described herein feature acupuncture needles that are individually oriented within a plurality of openings formed in the support material prior to an injection molding operation that connects the acupuncture needles to the support material. In some embodiments, the orientation of the acupuncture needles within the needle assemblies may be performed off-line (prior to the manufacturing process that incorporates the acupuncture needles into the 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 are connected to the support material with consistent orientation and spacing, further processing of the needle assemblies in a subsequent or adjacent production line may be facilitated. Thus, the present disclosure may facilitate high-throughput production of analyte sensors that can be inserted into tissues of interest with minimal trauma, thereby enabling a variety of user benefits to be realized.

[0014] Before describing the present needle assembly and associated methods of manufacture and use in further detail, a brief overview of suitable internal analyte sensors and analyte sensor applicators will be provided for further context of the present disclosure, however, it should be understood that analyte sensors and analyte sensor applicators having different architectures and components other than those explicitly described may also be suitably used.

[0015] FIG. 1 illustrates a diagram of an exemplary analyte monitoring system that may incorporate analyte sensors compatible with the disclosure herein. As shown, analyte monitoring system 100 includes a sensor control device 102 and a reader device 120 configured to communicate with each other via local or remote communication paths or links, wired or wireless, unidirectional or bidirectional, and encrypted or unencrypted. The reader device 120 may be a general-purpose smartphone or a dedicated electronic reader device. Although only one reader device 120 is shown, in certain cases, there may be two or more reader devices 120. The multiple reader devices 120 may be in communication with each other (e.g., to share and synchronize data). The reader device 120 may also communicate with a remote terminal 170 and / or a trusted computer system 180, respectively, via communication paths / links 141 and / or 142, wired or wireless, unidirectional or bidirectional, and encrypted or unencrypted. The reader device 120 may also communicate with a network 150 (e.g., a cellular network, the Internet, or a cloud server) via a communication path / link 151. The network 150 may be further communicatively connected to a remote terminal 170 via a communication path / link 152 and / or to a trusted computer system 180 via a communication path / link 153. In turn, in some embodiments, the remote terminal 170 and / or the trusted computer system 180 may communicate with the network 150. Alternatively, the sensor control device 102 may communicate directly with the remote terminal 170 and / or the trusted computer system 180 without the presence of an intervening reader device 120. According to some embodiments described in U.S. Patent Application Publication No. 2011 / 0213225 and incorporated herein by reference, for example, the sensor control device 102 may communicate with the remote terminal 170 and / or the trusted computer system 180 via a direct communication link to the network 150.Any suitable electronic communication protocol may be used for each local communication path or link, such as near field communication (NFC), radio frequency identification (RFID), BLUETOOTH or BLUETOOTH low energy protocols, WiFi, etc. The remote terminal 170 and / or the trusted computer system 180 may be accessible by individuals other than the primary user, according to some embodiments. The reader device 120 may include a display 122 and an optional input component 121. The display 122 may include a touch screen interface, according to some embodiments.

[0016] The sensor control device 102 includes a sensor housing 103, which may include circuitry and a power source for operating the sensor 104. Optionally, the power source and / or active circuitry may be omitted. The sensor 104 may include a sensor tail (active portion) having a length sufficient to insert at a desired depth into a tissue of interest, such as the dermis layer of the skin. The sensor tail, according to one or more embodiments, may include a sensing region that is active for sensing and may include an enzyme and / or a redox mediator. According to some embodiments, a polymeric membrane (mass transport limiting layer) may be disposed over the sensor tail or sensor to help regulate the flux of the analyte of interest.

[0017] One or more analyte values ​​can be determined using the sensor 104 and communicated to the reader device 120. The analyte may be monitored in any biological fluid, such as dermal fluid, plasma, blood, lymph, etc. The analytes that can be monitored are not considered to be particularly limiting. In certain embodiments, the analyte can be glucose. Other analytes of interest with respect to human physiology can include, for example, lactate, oxygen, pH, A1c, ketones, drug concentrations, etc. Both single analytes and combinations of analytes can be chemically analyzed.

[0018] The sensor 104 extends adjacent to the needle 109 in the configuration shown in FIG. 1. The needle 109 is momentarily present immediately prior to inserting the sensor 104 into tissue and is then withdrawn. While present, the needle 109 may facilitate the insertion of the sensor 104 into the tissue of interest by opening an access path for the sensor 104 to follow. For example, according to one or more embodiments, the needle 109 may facilitate the penetration of the epidermis as an access path to the dermis to allow the implantation of the sensor 104 to occur. In an exemplary embodiment, the needle 109 may be solid or hollow, beveled or non-beveled, and / or circular or non-circular in cross-section. Once the sensor 104 is inserted into tissue, the needle 109 is withdrawn, removed, and no longer deployed or associated with the sensor housing 103. That is, the needle is retracted or otherwise withdrawn into the analyte sensor inserter 200.

[0019] In the configuration shown in FIG. 1, the tip of the needle 109 is angled above the end of the sensor 104 so that the needle 109 penetrates the tissue first, opening an access path to the sensor 104. In an alternative embodiment, the body of the needle 109 may be angled relative to the sensor 104 so that the needle 109 penetrates the tissue of interest again before the sensor 104. The angled configuration of the needle 109 is described in further detail in commonly owned U.S. Patent Application Publication No. 2017 / 0196487, which is incorporated herein by reference in its entirety. In yet another alternative embodiment, the sensor 104 may reside within a lumen or groove of the needle 109, which similarly opens an access path for the sensor 104 to follow. Regardless of the configuration, once the sensor 104 is inserted into the tissue of interest, the needle 109 may be retracted from the tissue into an analyte sensor inserter (not shown in FIG. 1) to minimize the risk of sharps exposure.

[0020] Sensors 104 compatible with the analyte monitoring system 100 may include a two-electrode or three-electrode detection motif, according to various embodiments. A three-electrode detection motif may include a working electrode, a counter electrode, and a reference electrode. A two-electrode detection motif may include a working electrode and a second electrode, with the second electrode functioning 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 the analyte sensor 104 may be in contact with the working electrode. The various electrodes may be at least partially stacked or laterally spaced apart from one another with an insulating separator disposed therebetween. According to some embodiments of the present disclosure, a mass transfer membrane or biocompatible membrane may protect at least some of the electrodes, or the entire sensor.

[0021] It should be appreciated that analyte monitoring system 100 may include additional features and functionality not necessarily described herein for the sake of brevity, and therefore the foregoing description of analyte monitoring system 100 should be considered exemplary and non-limiting in nature.

[0022] The sensor 104 may be inserted into the tissue of a subject using an analyte sensor inserter further operable to position the sensor housing 103 on a tissue surface, such as the surface of the skin. Exemplary analyte sensor inserters operable to position the sensor housing on a skin surface are described in further detail in commonly owned U.S. Pat. Nos. 9,186,098 and 9,402,570, and commonly owned U.S. Patent Application Publication No. 2016 / 0331284, all of which are incorporated herein by reference in their entireties. FIG. 2 shows a view of a portion of an exemplary analyte sensor inserter 200 with needle 202 normally extending from needle holder 204, facilitating insertion of the dermal sensor, as described in more detail in U.S. Pat. No. 9,402,570. Needle structures similar in structure to needle holder 204 can be manufactured in accordance with the disclosure herein, as described below.

[0023] Accordingly, the needle assemblies and needle structures of the present disclosure will be described in further detail below with further reference to the drawings. The needle assemblies and needle structures described herein, according to various embodiments, can be incorporated into an insertion device for an analyte sensor, also referred to herein as an analyte sensor inserter.

[0024] In various embodiments, the needle assembly of the present disclosure includes a support material having a plurality of openings formed therein, and a first injection molded coupler disposed within each opening, the first injection molded coupler surrounding the proximal end of the acupuncture needle and connecting the acupuncture needle to a first location on the support material. The acupuncture needle is held in a predetermined orientation relative to the longitudinal axis of the first injection molded coupler. As used herein, the term "distal end" refers to a location on the shaft of the acupuncture needle proximal to the sharp point (i.e., the insertion end), and the term "proximal end" refers to a location on the shaft of the acupuncture needle proximal to the end opposite the insertion end. As used herein, the term "distal end" includes a portion of the acupuncture needle that includes at least the insertion end, and the term "proximal end" includes a portion of the acupuncture needle that includes the end opposite the insertion end.

[0025] Acupuncture needles suitable for use in the present disclosure are not to be considered as particularly limited in size or length unless otherwise indicated herein. In more specific embodiments, acupuncture needles suitable for use in the present disclosure may range between about 0.1 mm and about 0.6 mm in diameter, or between about 0.15 and about 0.4 mm in diameter, or between about 0.25 mm and about 0.35 mm in diameter, including any value or any subrange therein.

[0026] According to more specific embodiments, each acupuncture needle in the needle assembly may be held in substantially the same orientation within manufacturing tolerances. In some or other more specific embodiments, the acupuncture needles of adjacent openings may be substantially uniformly spaced apart from one another within manufacturing tolerances. The angular variation (variance) between multiple acupuncture needles in the needle assembly may be about 1 degree or less, or about 0.5 degrees or less, or about 0.25 degrees or less. According to various embodiments, the pitch (spacing between adjacent acupuncture needles) may be about 15 mm or less, or about 12 mm or less, or about 10 mm or less, or about 7 mm or less, or about 5 mm or less, with the pitch variation being about 0.02 mm or less. In more specific embodiments, the pitch may constitute a spacing between about 8 mm and about 10 mm, with the pitch variation being about 0.02 mm or less. In some or other embodiments, the length of the acupuncture needle may be about 20 mm or less, or about 15 mm or less, or about 12 mm or less, or about 10 mm or less, or about 8 mm or less, with a length variation of about 0.05 mm or less. In more specific embodiments, the length of the acupuncture needle may range between about 9 mm and about 12 mm, or between about 10 mm and about 11 mm, with a length variation of about 0.05 mm or less.

[0027] According to some embodiments, the acupuncture needle in each opening may be held non-parallel to the longitudinal axis of the first injection molded coupler. In more specific embodiments, the acupuncture needle in each opening may be held at an angle ranging between about 5° and about 15°, or between about 7° and about 12°, or between about 8° and about 11°, including any value or any subrange. Tilting the acupuncture needle stretches the skin to one side as it penetrates the skin, providing a gap to facilitate insertion of the sensor. In even more specific embodiments, the acupuncture needle in each opening may be held at an angle ranging between about 9° and about 10°, or between about 10°, including any value or subrange.

[0028] In certain embodiments, the needle assemblies described herein may further comprise a second injection molded coupler disposed within each aperture that surrounds the tip of the acupuncture needle and connects the acupuncture needle to a second location on the support material. The second injection molded coupler helps protect the insertion end of the acupuncture needle during manufacturing of the needle assemblies described herein, thereby potentially reducing the percentage of units that are rejected due to quality control defects during subsequent manufacturing of the analyte sensor inserter. Additionally, the second injection molded coupler can further stabilize the acupuncture needle within each aperture by limiting bending motion during manufacturing of the needle assembly. Alternatively, the second injection molded piece may surround the tip of the acupuncture needle but remain unattached (unconnected) to the support material. Such a configuration can similarly help protect the insertion end of the acupuncture needle.

[0029] FIG. 3 shows a diagram of a portion of a needle assembly of the present disclosure having multiple acupuncture needles attached in a predetermined orientation. As shown in FIG. 3, the needle assembly 300 is formed on a continuous support material 302. The continuous support material 302 can be a continuous metal tape, strip, or film, although alternative materials and forms that can be processed in a reel-to-reel manner can also be used in some cases. In some embodiments, stainless steel can be a suitable metal from which the needle assembly 300 can be manufactured. Other suitable tapes can include alternative metals or other materials that can withstand the injection molding temperatures required to manufacture the needle assembly 300. In alternative embodiments, the needle assembly 300 can be formed on a support material having a finite length, such that manufacture of the assembly is done in a separate unit rather than a continuous reel-to-reel process.

[0030] The aperture 304 is defined in the plane of the continuous support material 302, such as through a die cutting or stamping process. The formation of the aperture 304 may occur in conjunction with or prior to the process for manufacturing the needle assembly 300, or the aperture 304 may be present in the continuous support material 302 as obtained.

[0031] The acupuncture needles 306 may be attached to the continuous support material 302 at at least one location and positioned in-plane in each opening 304. At least the proximal end 306a of each acupuncture needle 306 is surrounded by a first injection molded coupler 308 adjacent the continuous support material 302 at the proximal end 306a via a neck 310. Each neck 310 may extend from the continuous support material 302 to each opening 304 such that the first injection molded coupler 308 surrounds the neck 310. According to a more specific embodiment, the neck 310 may coincide with a longitudinal axis A of the first injection molded coupler 308. As shown in FIG. 3, the neck 310 terminates inside the first injection molded coupler 308. As discussed in more detail herein, the size and shape of the first injection molded coupler 308 may be selected to facilitate its incorporation into an analyte sensor inserter (see FIG. 2). It should be understood that the particular size and / or shape of the first injection molded coupler 308 is not particularly limited.

[0032] In some embodiments, the first injected molded coupler 308 may include legs 312 radially offset from the longitudinal axis A. The proximal end 306a of the acupuncture needle 306 may be surrounded by the legs 312, and the distal end 306b of the acupuncture needle 306 may protrude into the opening 304 and beyond. Specifically, according to certain embodiments, the distal portion 306b may extend from the legs 312 at a non-zero angle relative to the longitudinal axis A. In addition to serving as an attachment point for the acupuncture needle 306, the legs 312 may function as a "keying feature" to facilitate proper orientation in the analyte sensor inserter. While FIG. 3 illustrates the first injection molded coupler 308 as including one leg 312, it should be understood that in alternative embodiments, multiple legs 312 may be present. Multiple legs 312 may provide additional keying features to facilitate assembly of the analyte sensor inserter. When multiple legs 312 are present, the tip 306b of the acupuncture needle 306 may extend from one leg 312 while the remainder of the leg 312 does not contact the acupuncture needle 306 or additional needles.

[0033] As discussed in more detail below, when the individual acupuncture needles 306 are separated from the needle assembly 300 as a needle configuration, the first injection molded coupler 308 and the acupuncture needles 306 may be adapted to remain connected to one another. To facilitate keeping the acupuncture needles 306 connected together with the first injection molded coupler 308, the proximal end 306a of the acupuncture needles 306 may be modified to promote retention within the first injection molded coupler 308, according to some embodiments. Specifically, according to some embodiments, the proximal end 306a of the acupuncture needles 306 may include a bend, a pinch point, or any combination thereof to promote retention of the acupuncture needles 306 within the first injection molded coupler 308. The bend or pinch point creates a physical barrier to withdrawal of the needle from the first injection molded coupler 308. 4A and 4B show enlarged cross-sectional views of an individual acupuncture needle 306 in the needle assembly 300 (FIG. 3), where the first injection molded coupler 308 includes an acupuncture needle 306 with a modification at the proximal end. Specifically, the acupuncture needle 306 includes a pinch point 422 in the leg 312 in FIG. 4A, and in FIG. 4B, the acupuncture needle 306 includes a bend 423 in the leg 312.

[0034] According to some embodiments, a second connection location between the acupuncture needle 306 and the continuous support material 302 may be present in the needle assembly 300. Specifically, referring again to FIG. 3, an optional second injection molded coupler 324 may surround the tip 306b of the acupuncture needle 306 and connect the acupuncture needle 306 to a second location 325 on the continuous support material 302. Alternatively, the second injection molded coupler 324 may surround the tip 306b without connecting to the continuous support material 302, in which case the second injection molded coupler 324 may instead be considered an injection molded piece. In the two-connection configuration shown in FIG. 3, the second injection molded coupler 324 is positioned approximately opposite the neck 310 of the opening 304. The location of the second injection molded coupler 324 may be selected such that the insertion end of the acupuncture needle 306 is surrounded following injection molding, thereby protecting the insertion end from damage during manipulation of the acupuncture needle 306. Even when the second injection molded coupler 324 is not connected to the continuous support material 302, the insertion end of the acupuncture needle 306 may still be protected. The shape of the second injection molded coupler 324 is not considered to be particularly limiting, and the generally trapezoidal configuration shown should not be considered to limit the scope of the present disclosure. According to a more specific embodiment, the second injection molded coupler 324 may be bisected by a plane of the continuous support material 302 such that a first portion of the second injection molded coupler 324 is formed on a first side of the plane of the continuous support material 302 and a second portion of the second injection molded coupler 324 is formed on a second side of the plane.

[0035] Unlike the first injection molded coupler 308, the second injection molded coupler 324 may be configured to establish a temporary connection between the acupuncture needle 306 and the continuous support material 302. More specifically, the acupuncture needle 306 may be configured to be easily removed from the second injection molded coupler 324 at a desired time, thereby freeing the insertion end to facilitate tissue penetration, such as for insertion of an analyte sensor. According to various embodiments, the acupuncture needle 306 may be tapered at the tip 306b (e.g., adjacent the insertion end), such that release of the acupuncture needle 306 from the second injection molded coupler 324 may be affected by a light pulling action. In some embodiments, either separately or in combination with the tapering of the tip 306b, a non-stick material, such as, for example, a silicone or polytetrafluoroethylene coating, may be applied to the acupuncture needle 306 to facilitate removal from the second injection molded coupler 324.

[0036] Also contemplated herein are various methods for manufacturing and using the needle assemblies of the present disclosure. A method for using the needle assembly may include separating individual acupuncture needles arranged in a defined direction within the needle structure and incorporating the oriented acupuncture needles into an analyte sensor inserter, as described in further detail below.

[0037] A method for manufacturing a needle assembly of the present disclosure may include providing a support material having a plurality of openings formed therein and a neck extending from the support material into each opening, positioning an acupuncture needle in each opening, and connecting the acupuncture needle to a first location on the support material through the neck by injection molding a polymeric material to form a first injection molded coupler that encircles both the neck and the proximal end of the acupuncture needle in each opening. The needle assembly may be manufactured such that the neck is aligned with a longitudinal axis of the first injection molded coupler and the acupuncture needle is held in a predetermined orientation relative to the longitudinal axis, for example as shown in FIG.

[0038] In more specific embodiments, the support material may include a continuous support material, such as a continuous metal tape. According to some further embodiments, the method for manufacturing the needle assembly of the present disclosure may further include injection molding a polymeric material to form a second injection molded coupler that surrounds the tip of the acupuncture needle in each opening and connects the acupuncture needle to a second location on the support material. Alternatively, the second injection molded coupler (injection molded piece) that surrounds the tip of the acupuncture needle in each opening can be similarly manufactured without connecting it to the support material.

[0039] Suitable injection molding processes for forming the first and second injection molded couplers are well known to those skilled in the art. Such processes include disposing one or more molds in each opening and injecting a polymeric material into the molds to form the first injection molded coupler and optionally the second injection molded coupler, each injection molded coupler being disposed as described above. The first and second injection molded couplers can be formed in the same injection molding process or in separate injection molding processes. Furthermore, the polymeric materials used to form the first injection molded coupler and the second injection molded coupler can be the same or different. Any suitable thermoplastic or thermosetting polymeric material can be used to form the first and second injection molded couplers. For example, in some embodiments, the first injection molded coupler can be formed from a rigid polymeric material that can facilitate the use of a needle structure in the analyte sensor inserter, and the second injection molded coupler can be formed from a compliant polymeric material that can facilitate the removal of the needle at a desired time. The injection molding process may further include placing an acupuncture needle into each mold prior to injecting the polymeric material. In some embodiments, the acupuncture needles may be placed into the molds using manual or automated pick-and-place techniques.

[0040] The method for manufacturing the needle assembly of the present disclosure may further include, in some embodiments, stamping or die-cutting the support material to define a plurality of openings. The openings 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 are well known to those skilled in the art. The die-cutting or stamping process may be performed integrally with the injection molding process or in a separate production line prior to the injection molding process. In other embodiments, the support material may be obtained, supplied, or purchased with a plurality of openings already formed therein.

[0041] 5A-5C show diagrams illustrating an exemplary process by which a first configuration of the needle assembly of the present disclosure may be manufactured. For clarity, FIGs. 5A-5C show the manufacturing of the needle assembly occurring at two openings, however, it should be understood that the illustrated concepts may be extended to manufacturing occurring at two or more openings in a support material, either simultaneously or non-simultaneously (sequentially).

[0042] 5A, a continuous metal tape 502 having a plurality of apertures 504 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 manufacture of the needle assembly. A neck 506 extends into each aperture 504 as an elongated member.

[0043] Next, as shown in Figure 5B, a mold 508 with an acupuncture needle 510 disposed therein is placed into each opening 504 in preparation for injection molding. Further details regarding the mold 508 and the positioning of the acupuncture needle 510 therein are provided below with reference to Figures 7A and 7B. Because the neck 506 extends into the mold 508, a connection between the continuous metal tape 502 and the acupuncture needle 510 occurs during injection molding. A second connection between the continuous metal tape 502 and the acupuncture needle 510 may also be present on the distal side of the acupuncture needle 510.

[0044] 5C illustrates the next stage in the process for manufacturing the needle assembly 500, where the injection molding process has been completed and the mold 508 has been removed from each opening 504. Following the injection molding process, the acupuncture needle 510 is connected to the continuous metal tape 502 at the neck 506 via a first injection mold coupler 512 and optionally via a second injection mold coupler 514 at the bottom of the opening 504. The second injection mold coupler 514 is removably connected to the acupuncture needle 510, as described above, to help protect the insertion end during assembly manufacturing and needle manipulation.

[0045] Although FIG. 5B illustrates an acupuncture needle 510 housed in a single mold 510 for forming first and second injection molded couplers 512, 514, alternatively, a second mold 511 can be utilized to form a second injection molded coupler 514 about the tip 513, as shown, for example, in FIG. 5D, without departing from the scope of the present disclosure.

[0046] Alternatively, the tip 513 of the acupuncture needle 510 may be outside the mold 508 and remain unsupported throughout the injection molding process. Figures 6A-6C show diagrams illustrating an exemplary process by which the second configuration of the needle assembly of the present disclosure may be manufactured. That is, the needle assembly 501 shown in Figure 6C omits the second injection molding coupler 514, so that the acupuncture needle 510 is connected to the continuous metal tape 502 by being supported only in the first injection molding coupler 512. Except for the placement of the acupuncture needle 510 in the mold 508, the operation shown in Figures 6A-6C is similar to that shown in Figures 5A-5C, and therefore will not be described in detail again.

[0047] Each mold 508 has a shape complementarity with each opening 504 such that the mold 508 fits therein and covers one or more desired portions of the continuous metal tape 502. If a second mold 511 is used to form a second injection molded coupler 514, it can cover the bottom of the continuous metal tape 502 as well. According to some embodiments, the mold 508 can be a two-plate mold to facilitate loading of the acupuncture needle 510 therein. In such an embodiment, the first mold 508 is positioned adjacent to a first side of the continuous metal tape 502 and the second mold 508 is positioned adjacent to a second side of the continuous metal tape 502. One or more cavities can be defined between the two molds, as described below with reference to FIGS. 7A-7C. The one or more cavities can be bisected by a plane of the continuous metal tape 502. The neck 506 can extend into at least one of the cavities such that the injection molding forms a connection between the acupuncture needle 510 and the neck 506. Mold 508 may be a two-plate mold to facilitate loading of acupuncture needles 510, although it should be understood that mold 508 may be a single piece mold in some alternative embodiments.

[0048] 7A and 7B show an exemplary view of the mold 508 positioned within the opening 504, with a single piece (hemisphere) of the mold 508 shown to show the internal details of the mold 508 and the location of the acupuncture needle 510 therein. As shown in FIG. 5B, the two parts (hemispheres) of the mold 508 can be assembled together within the opening 504 in preparation for injection molding.

[0049] Referring to FIG. 7A, the mold 508 includes cavities 606, 608 therein. The cavities 606, 608 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 form a first injection molded coupler 512 (FIG. 5C) and a second injection molded coupler 514 (FIG. 5C), respectively. The neck 506 extends into the cavity 606 such that the first injection molded coupler 512 (FIG. 5C) is formed within the cavity 606 and surrounds the neck 506. The second injection molded coupler 514 (FIG. 5C) is formed within the cavity 608. The cavity 608 covers a corresponding notch in the continuous metal tape 502 at the bottom of the opening 504, with a first portion of the second injection molded coupler 514 (FIG. 5C) covering the notch and a second portion formed on the continuous metal tape 502. Alternatively, a second injection molded coupler 514 (injection molded piece) can surround the tip 510 b of the acupuncture needle 510 but does not form a connection to the continuous metal tape 502 .

[0050] The needle channel 610 extends between the cavity 606 and the cavity 608. The needle channel 610 is sized to receive the acupuncture needle 510, as shown in FIG. 7B, with the proximal end 510a of the acupuncture needle 510 extending into the cavity 606 and the distal end 510b of the acupuncture needle 510 extending into the cavity 608. When injection molding is performed to form the first injection molded coupler 512 (FIG. 5C) and the second injection molded coupler 514 (FIG. 5C), the acupuncture needle 510 is connected to the continuous metal tape 502 at both the distal and proximal ends and held in a predetermined orientation for further manipulation. The needle channel 610 is generally not filled with a thermoplastic or thermosetting material during the injection molding operation.

[0051] As mentioned above, the tip 510b of the acupuncture needle 510 may also be unsupported, as shown for the needle assembly 501 in Fig. 6C. A mold omitting the needle groove 610 and cavity 608 may be used when forming the needle assembly 501 with the acupuncture needle 510 having the unsupported tip 510b. Fig. 7C shows an exemplary configuration of a mold 509 suitable for forming the needle assembly 501 with the tip 510b of the acupuncture needle 510 in an unsupported state.

[0052] Once the injection molding is completed and each mold 508 is removed, the needle assembly 500 (FIG. 5C) or 501 (FIG. 6C) may be stored for further use or directly fed into a process for manufacturing an analyte sensor inserter, for example as shown in FIG. 2. In either case, the position of each acupuncture needle 510 remains fixed relative to the first injection mold coupler 514 until further needle manipulation is performed, as described below. Furthermore, the separation and orientation of each acupuncture needle 510 remains fixed relative to each other, facilitating further needle manipulation. In a more specific embodiment, each acupuncture needle 510 may be substantially uniformly spaced apart. Because the needle assembly 500 or 501 provides a highly ordered and regular arrangement of multiple acupuncture needles 510, they may be manipulated in a manner similar to a conventional array of larger gauge needles or similar sharps. Thus, the needle assembly of the present disclosure may facilitate a variety of manufacturing processes with minor modifications to existing production lines, as described below. That is, the needle assemblies of the present disclosure can directly replace larger gauge needles or similar sharps arrays used in current manufacturing processes.

[0053] Prior to incorporation into an analyte sensor inserter or other type of device, the individual acupuncture needles 510 are removed from the needle assembly 500 in the form of a needle structure. The needle structure includes the acupuncture needle 510 and a first injection molded coupler 512, with the acupuncture needle 510 being maintained in a predetermined orientation relative to the longitudinal axis of the first injection molded coupler 512, in particular in a non-parallel orientation relative to the longitudinal axis. Operations affecting the removal of the individual needle structures are described below with reference to Figures 8A and 8B. The removal of the individual needle structures may be performed as a further operation to form the needle assembly 500 or as a completely separate process, according to various embodiments.

[0054] Thus, in further embodiments, the method of the present disclosure may include separating the needle structure from a support material, such as a continuous metal tape, separating the second injection molded coupler, if present, and incorporating the needle structure into an analyte sensor inserter or another type of device. The needle structure includes an acupuncture needle and a first injection molded coupler, the first injection molded coupler surrounding a proximal end of the acupuncture needle. In some embodiments, the proximal end of the acupuncture needle may include a pinch point, a bend, or any combination thereof to facilitate retention in the first injection molded coupler.

[0055] In further embodiments, separating the needle structure may include cutting the neck adjacent the first injection molded coupler and pulling the tip of the acupuncture needle from the second injection molded coupler. In embodiments where there is no second injection molded coupler, the needle structure is released directly from the needle assembly by cutting the neck adjacent the first injection molded coupler. Cutting the neck to release the needle structure leaves a metal core within the first injection molded coupler, which may be aligned with the longitudinal axis of the first injection molded coupler. Once separated from the needle assembly, the individual needle structures may be further manipulated and placed into a production line.

[0056] As shown in FIG. 8A, the neck 506 may be cut to sever the first connection with the continuous metal tape 502. Cutting the neck 506 may be done using any suitable method, such as guillotine cutting, die cutting, scissor cutting, etc. Once the neck 506 is cut, the first injection molded coupler 514 and the acupuncture needle 510 are free to move together along the longitudinal axis A. Application of a gentle axial pulling force F (indicated by a block arrow) along the longitudinal axis A may be sufficient to disengage the acupuncture needle 510 from the second injection molded coupler 514, thereby releasing the needle structure 700 (FIG. 8B). A similar operation may be used to separate the needle structure 700 in embodiments that do not have a second injection molded coupler 514 or that have a second injection molded coupler 514 that is not connected to the metal tape 502, such as the needle assembly 501. The needle structure 700 includes an acupuncture needle 510 held in a defined configuration with respect to a first injection molded coupler 512, as discussed herein.

[0057] Embodiments disclosed herein include the following. A. The needle assembly includes a support material having a plurality of openings formed therein, and a first injection molded coupler disposed within each opening, the first injection molded coupler surrounding a proximal end of an acupuncture needle and connecting the acupuncture needle to a first location on the support material, the acupuncture needle being held in a predetermined orientation relative to a longitudinal axis of the first injection molded coupler.

[0058] B. The needle structure comprises an acupuncture needle having a proximal end surrounded by an injection molded piece, the acupuncture needle being oriented non-parallel to the longitudinal axis of the injection molded piece. C. Methods for Forming and Operating a Needle Assembly The method may include providing a support material having a plurality of openings formed therein and a neck extending from the support material into each opening, disposing an acupuncture needle in each opening, and connecting the acupuncture needle to a first location on the support material by injection molding a polymeric material to form a first injection molded coupler that encircles both the neck and the proximal end of the acupuncture needle in each opening. The neck is co-located with a longitudinal axis of the first injection molded coupler. The acupuncture needle is held in a predetermined orientation relative to the longitudinal axis.

[0059] Each of embodiments A, B, and C may have one or more of the following additional elements in any combination. Element 1: The support material comprises a continuous metal tape.

[0060] Element 2: A neck extends from the support material into each opening, and a first injection molded coupler surrounds the neck such that the neck is aligned with the longitudinal axis. Element 3: The needle assembly may further comprise a second injection molded coupler disposed within each opening that surrounds the tip of the acupuncture needle and connects the acupuncture needle to a second location on the support material.

[0061] Element 4: The acupuncture needle is held non-parallel to its longitudinal axis. Element 5: The acupuncture needle is held at an angle ranging from about 5° to about 15° relative to the longitudinal axis. Element 6: The proximal end of the acupuncture needle is bent, contains a pinch point, or any combination thereof.

[0062] Element 7: The first injection molded coupler includes a leg radially offset from the longitudinal axis, the base end of the acupuncture needle is surrounded by the leg, and the tip of the acupuncture needle extends from the leg at a non-zero angle relative to the longitudinal axis.

[0063] Element 8: The support material includes a continuous metal tape, a neck extends from the continuous metal tape into each opening, and a first injection molded coupler surrounds the neck such that the neck is coincident with the longitudinal axis. Element 9: Acupuncture needles range in diameter from about 0.1 mm to about 0.6 mm.

[0064] Element 10: Acupuncture needles in adjacent openings are substantially uniformly spaced apart. Element 11: The needle structure further includes a metal core within the injection molded piece that is aligned with the longitudinal axis. Element 12: The method may further include injection molding a polymeric material to form a second injection molded coupler that surrounds the tip of the acupuncture needle and connects the acupuncture needle to a second location on the support material.

[0065] Element 13: The method includes separating the needle structure from the support material and the second injection molded coupler, and incorporating the needle structure into an insertion device for an analyte sensor. The needle structure includes an acupuncture needle and the first injection molded coupler.

[0066] Element 14: Separating the needle structure includes cutting the neck adjacent to the first injection molded coupler and pulling the tip of the acupuncture needle from the second injection molded coupler. Element 15: The method includes separating a needle structure from a support material and incorporating the needle structure into an insertion device of an analyte sensor. The needle structure includes an acupuncture needle and a first injection molded coupler.

[0067] Element 16: Separating the needle structure includes cutting the neck adjacent to the first injection molded coupler. Element 17: The needle assembly further includes an injection molded piece disposed within each opening surrounding the tip of the acupuncture needle.

[0068] Element 18: The method includes separating the needle structure from the support material and incorporating the needle structure into an insertion device of an analyte sensor. The needle structure includes an acupuncture needle and a first injection molded coupler.

[0069] As a non-limiting example, exemplary combinations applicable to A, B, and C include: element 1 and element 2, element 1 and element 3, element 1 and element 4, element 1 and element 5, element 1 and element 6, element 1 and element 7, element 1 and element 9, element 1 and element 10, element 1 and element 17, element 2 and element 3, element 2 and element 4, elements 2 through 4, element 2 and element 5, element 2, element 3 and element 5, element 2 and element 6, element 2 and element 7, element 2 and element 9, element 2 and element 10, element 2 and element 17, element 3 and element 4, element 3 and element 5, element 3 and element 6, element 3 and element 7, element 3 and element 8, element 3 and element 9, element 3 and element 10, element 3 and element 17, element 4 and Needle assembly of A in combination with element 6, element 4 and element 7, element 4 and element 8, element 4 and element 9, element 4 and element 10, element 4 and element 17, element 5 and element 6, element 5 and element 7, element 5 and element 8, element 5 and element 9, element 5 and element 10, element 5 and element 17, element 6 and element 7, element 6 and element 8, element 6 and element 9, element 6 and element 10, element 6 and element 17, element 7 and element 8, element 7 and element 9, element 7 and element 10, element 7 and element 17, element 8 and element 9, element 8 and element 10, element 8 and element 17, element 9 and element 17, element 9 and element 10. Needle structure B combined with element 5 and element 6, element 5 and element 7, element 5 and element 9, element 5 and element 11, element 6 and element 7, element 6 and element 9, element 6 and element 11, element 7 and element 9, element 7 and element 11, element 9 and element 11.element 1 and element 4, element 1 and element 5, element 1 and element 6, element 1 and element 7, element 1 and element 9, element 1 and element 10, element 1 and element 12, element 1 and element 12 and element 13, element 1 and element 12 to element 14, element 1 and element 15, element 1 and element 18, element 1 and element 15 and element 16, element 4 and element 6, element 4 and element 7, element 4 and element 9, element 4 and element 10, element 4 and element 12, element 4 and element 12 and element 13, element 4 and element 12 to element 14, element 4 and 15, element 4 and element 18, element 4 and element 15 and element 16, element 5 and element 6, element 5 and element 7, element 5 and element 9, element 5 and element 10, element 5 and element 12, element 5 and element 12 and element 13, element 5 and element 12 to element 14, element 5 and element 15, element 5 and element 18, element 5 and Element 15 and element 16, element 6 and element 7, element 6 and element 9, element 6 and element 10, element 6 and element 12, element 6, element 12 and element 13, element 6 and element 15, element 6 and element 18, element 6, element 15 and element 16, element 7 and element 9, element 7 and element 10, element 7 and element 12, element 7, element 12 and element 13, element 7 and element 15, element 7 and element 18, element 7, element 15 and element 16 , element 9 and element 10, element 9 and element 12, element 9, element 12 and element 13, element 9 and element 15, element 9 and element 18, element 9, element 15 and element 16, element 10 and element 12, element 10, element 12 and element 13, element 10 and element 15, element 10 and element 18, element 10, element 15 and element 16, element 12 and element 13, elements 12 to 14, element 15 and element 16.

[0070] Unless otherwise indicated, all numbers expressing quantities and the like in this specification and the related claims should be understood in all instances to be modified by the term "about." Accordingly, unless expressly indicated otherwise, the numerical parameters set forth in the following specification and appended claims are approximations that may vary depending on the desired properties sought to be obtained by the embodiments of the present disclosure. At the very least, and without limiting the application of the doctrine of equivalents to the scope of the claims, each numerical parameter should at least be construed in light of the number of reported significant digits and by applying ordinary rounding techniques.

[0071] One or more exemplary embodiments incorporating various features are presented herein. For the sake of clarity, not all features of a physical implementation are described or shown in this application. It is understood that in developing a physical embodiment incorporating an embodiment of the present disclosure, numerous implementation-specific decisions must be made to achieve the developer's goals, including system-related, business-related, government-related and other constraints that vary from implementation to implementation. While the developer's efforts may be time-consuming, such efforts are nevertheless routine for those of ordinary skill in the art and would have the benefit of this disclosure.

[0072] Although various systems, tools, and methods are described herein in terms of "including" various components or steps, the systems, tools, and methods may also be "consisting essentially of" or "consisting of" various components and steps.

[0073] As used herein, the phrase "at least one" preceding a list of items, with the term "and" or "or" separating any of the items, modifies the entire list and not each item in the list. The phrase "at least one" allows for the meaning of including 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. By way of example, the phrases "at least one of A, B, and C" or "at least one of A, B, or C" all refer to A alone, B alone, or C alone, or any combination of A, B, and C, and / or at least one of each of A, B, and C.

[0074] Thus, the disclosed systems, tools, and methods are well adapted to achieve the objects and advantages mentioned, as well as those inherent therein. The specific embodiments disclosed above are illustrative only, as the teachings of the disclosure may be modified and implemented in different equivalent manners apparent to those skilled in the art having the benefit of the teachings herein. Moreover, no limitations are intended to be imposed on the details of construction or design shown herein, except as set forth in the following claims. Thus, it is apparent that the specific exemplary embodiments disclosed above may be altered, combined, or modified, and all such modifications are deemed to be within the scope of the present disclosure. The systems, tools, and methods illustratively disclosed herein may be suitably practiced in the absence of elements not specifically disclosed herein and / or in the omission of optional elements disclosed herein. Although the systems, tools, and methods are described in terms of "comprising," "including," or "including" various components or steps, the systems, tools, and methods may also be "consisting essentially of" or "consisting of" the various components and steps. All numerical values ​​and ranges disclosed above may vary somewhat. Whenever a numerical range with a lower limit and an upper limit is disclosed, any number within that range and any included range is specifically disclosed. In particular, all range values ​​disclosed herein (such as "about a to about b," or equivalently "about a to b," or equivalently "about a to b") should be understood to be all numbers and ranges within the broader range value. Moreover, terms in the claims have their plain and ordinary meaning unless expressly and unambiguously defined by the patent owner. Moreover, "a" or "1," as used in the claims, is defined herein to mean one or more elements that it introduces. In the event of a discrepancy between the usage of a word or term in this specification and one or more patent documents or other documents incorporated herein by reference, the definition consistent with this specification should be adopted.

Claims

1. 1. An inserter for a analyte monitoring system, comprising: a needle structure comprising an injection molded piece surrounding an acupuncture needle, a portion of the acupuncture needle extending from the injection molded piece being oriented non-parallel to a longitudinal axis of the injection molded piece, the injection molded piece comprising a metal core aligned with the longitudinal axis; a test substance sensor disposed adjacent to the portion of the acupuncture needle; wherein a tip or body of the acupuncture needle is angled relative to the test substance sensor, and a portion of the test substance sensor and the portion of the acupuncture needle are configured to be inserted into subcutaneous tissue of a subject.

2. The inserter of claim 1 , wherein the proximal end of the acupuncture needle is bent, includes a pinch point, or any combination thereof.

3. The inserter of claim 1 , wherein the acupuncture needle has a diameter of about 0.15 mm to about 0.4 mm.

4. The inserter of claim 1 , wherein the acupuncture needle has a diameter of about 0.25 mm to about 0.35 mm.

5. The inserter of claim 1 , wherein the acupuncture needle is held at an angle ranging from about 5° to about 15° relative to the longitudinal axis of the injection molded piece.

6. The inserter of claim 1 , wherein the acupuncture needle is held at an angle ranging from about 7° to about 12° relative to the longitudinal axis of the injection molded piece.

7. The inserter of claim 1 , wherein the acupuncture needle is held at an angle ranging from about 8° to about 11° relative to the longitudinal axis of the injection molded piece.

8. The inserter of claim 1 , wherein the acupuncture needle is held at an angle ranging from about 9° to about 10° relative to the longitudinal axis of the injection molded piece.

9. The inserter of claim 1 , wherein the analyte sensor comprises a sensor tail.

10. The inserter of claim 9 , wherein the sensor tail comprises a sensing region that includes an enzyme.

11. The inserter of claim 9 , wherein the sensor tail comprises a sensing region that includes a redox mediator.

12. The inserter of claim 9 , wherein the analyte sensor further comprises a polymer membrane disposed around the sensor tail.

13. The inserter of claim 12 , wherein the polymer membrane is a mass transport limiting layer.

14. The analyte sensor is configured to determine one or more analyte values. The inserter of claim 1 .

15. The inserter of claim 14 , wherein the analyte sensor is configured to determine one or more blood glucose levels.

16. The inserter of claim 14 , wherein the analyte sensor is configured to determine one or more lactate values.

17. The inserter of claim 14 , wherein the analyte sensor is configured to determine one or more values ​​of ketones.

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