EP-4740857-A1 - NEEDLE ASSEMBLIES CONTAINING ORIENTED ACUPUNCTURE NEEDLES AND METHODS FOR PRODUCTION THEREOF

Abstract

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.

Inventors

• CHO, HYUN
• WANG, YI

Assignees

• Abbott Diabetes Care, Inc.

Dates

Publication Date

20260513

Application Date

20190822

Claims (15)

1. An inserter for an analyte monitoring system, comprising: a needle construct comprising an injection molded piece surrounding an acupuncture needle, wherein a portion of the acupuncture needle extends from the injection molded piece and wherein the acupuncture needle is oriented non-parallel with respect to a longitudinal axis of the injection molded piece, and wherein the injection-molded piece comprises a metal core that is coincident with the longitudinal axis; and an analyte sensor located adjacent to the portion of the acupuncture needle, wherein a tip or a body of the acupuncture needle is angled with respect to the analyte sensor, wherein the portion of the acupuncture needle is configured to facilitate insertion of the analyte sensor into a tissue under the skin of a subject.
2. The inserter of claim 1, wherein a proximal portion of the acupuncture needle is bent, contains a pinch point, or any combination thereof.
3. The inserter of claim 1, wherein the acupuncture needle has a diameter of between about 0.15 and about 0.4 mm.
4. The inserter of claim 1, wherein the acupuncture needle has a diameter of between about 0.25 and about 0.35 mm.
5. The inserter of claim 1, wherein the acupuncture needle is held at an angle ranging between about 5° and about 15° to a longitudinal axis of the injection molded piece.
6. The inserter of claim 1, wherein the acupuncture needle is held at an angle ranging between about 7° and about 12° to a longitudinal axis of the injection molded piece.
7. The inserter of claim 1, wherein the acupuncture needle is held at an angle ranging between about 8° and about 11° to a longitudinal axis of the injection molded piece.
8. The inserter of claim 1, wherein the acupuncture needle is held at an angle ranging between about 9° and about 10° to a 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 comprising an enzyme, and or wherein the sensor tail comprises a sensing region comprising a redox mediator.
11. The inserter of claim 9 or 10, wherein the analyte sensor further comprises a polymeric membrane disposed about the senor tail, optionally wherein the polymeric membrane is a mass transport limiting layer.
12. The inserter of claim 1, wherein the analyte sensor is configured to determine one or more analyte levels.
13. The inserter of claim 12, wherein the analyte sensor is configured to determine one or more glucose levels.
14. The inserter of claim 12, wherein the analyte sensor is configured to determine one or more lactate levels.
15. The inserter of claim 12, wherein the analyte sensor is configured to determine one or more levels of ketones.

Description

BACKGROUND The detection of various analytes within an individual can sometimes be vital for monitoring the condition of their health. Deviation from normal analyte levels can often be indicative of a number of physiological conditions. Glucose levels, for example, can be particularly important to detect and monitor in diabetic individuals. By monitoring glucose levels with sufficient regularity, a diabetic individual may be able to take corrective action (e.g., by injecting insulin to lower glucose levels or by eating to raise glucose levels) before significant physiological harm occurs. Other analytes commonly subject to physiological dysregulation that may similarly be desirable to monitor include, but are not limited to, lactate, oxygen, pH, A1c, ketones, drug levels, and the like. 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. BRIEF DESCRIPTION OF THE DRAWINGS The following figures are included to illustrate certain aspects of the present disc