PRIORITY

[0001] The present application claims priority to U.S. provisional application no.

61/710,743 filed October 7, 2012, entitled "Medical Device Insertion Indicators", the disclosure of which is incorporated herein by reference for all purposes.

FIELD OF THE DISCLOSURE

[0002] Aspects of the present disclosure relate generally to medical device inserters, and indicators of medical device insertions, including analyte sensor and drug infusion set devices and the readiness for use of the same.

BACKGROUND

[0003] Diabetes Mellitus is an incurable chronic disease in which the body does not produce or properly utilize insulin. Insulin is a hormone produced by the pancreas that regulates blood sugar (glucose). In particular, when blood sugar levels rise, e.g., after a meal, insulin lowers the blood sugar levels by facilitating blood glucose to move from the blood into the body cells. Thus, when the pancreas does not produce sufficient insulin (a condition known as Type 1 Diabetes) or does not properly utilize insulin (a condition known as Type II Diabetes), the blood glucose remains in the blood resulting in hyperglycemia or abnormally high blood sugar levels.

[0004] The vast and uncontrolled fluctuations in blood glucose levels in people suffering from diabetes cause long-term, serious complications. Some of these complications include blindness, kidney failure, and nerve damage. Additionally, it is known that diabetes is a factor in accelerating cardiovascular diseases such as atherosclerosis (hardening of the arteries), leading to stroke, coronary heart disease, and other diseases. Accordingly, one important and universal strategy in managing diabetes is to control blood glucose levels.

[0005] One element of managing blood glucose levels is testing to monitor blood glucose levels. Conventional in vitro techniques, such as drawing blood samples, applying the blood to a test strip, and determining the blood glucose level using colorimetric, electrochemical, or photometric test meters may be employed. Another more recent technique for monitoring glucose levels is in vivo glucose monitoring which employs an in vivo glucose monitoring system that continuously or automatically tests glucose while the sensor is positioned in vivo. An in vivo analyte sensor such as an in vivo glucose sensor, is at least partially inserted into the skin for a period of time, during which time it automatically monitors for the presence and/or concentration of one or more analytes in bodily fluid such as blood, interstitial fluid, or the like.

[0006] In using an in vivo glucose monitoring system, at least a portion of a new analyte sensor is inserted under a skin surface. An inserter device may be employed to insert the analyte sensor in the body of the user. (Such an inserter device may be referred to as an "inserter" or alternatively as an "inserter assembly," an "insertion" device or assembly or an "applicator" device or assembly, etc.). Depending on the inserter configuration, it may not be possible (or it may be confusing) to determine whether a particular inserter device has been used/spent without opening the device to examine its interior and breaching the sterile barrier. However, compromising sterility would require the device to be discarded without using it. It is therefore advantageous to provide a clear and unambiguous indication of the device use status. Aspects of embodiments of the present disclosure meet this need.

SUMMARY

[0007] With an inserter device (e.g., one which may include a cap or cover to define sterile packaging together with a housing), a user may benefit from a visual and/or audible indication of device actuation, for example to prevent discarding an unused inserter or attempting to use a used inserter, or opening the sterile cover of an unused unit to check the same. Accordingly, one or more inserter status indicators are provided that clearly and unambiguously indicate whether or not an inserter device has been used, without resort to opening the device package and prematurely breaching its sterile barrier.

[0008] Such an indication/indicator feature is particularly advantageous for any type of medical device inserter, including analyte monitoring inserters such as ketone and glucose monitoring inserters for example. Contemplated herein are any medical device inserters that may suggest or require that the user carry a spare or second inserter device. If the spare device needs to be used while away from a disposal receptacle, the user may later have a difficult time determining which device was used (or be unable to distinguish between used and unused) and thus which device should be disposed of without opening the device and breaking the sterile barrier if need be. Use indicators described herein are configured to provide visual and/or audible and/or tactile and/or physical usage confirmation through external inspection only, to indicate whether or not an insertion device has been deployed to insert a respective medical device. When visual usage features are employed, such features may also (or alternatively) serve as a "Do Not Use if Visible" type indicator(s). When physical usage features are employed, such features may permanently inactivate an inserter device to prevent reuse.

[0009] The use indication approaches described herein can be implemented with any type of medical device insertion device (e.g., for in vivo analyte sensors, insulin pump infusion sets, etc.).

[0010] Embodiments can be incorporated in any insertion device that contains a housing and an internal moveable member that moves inside the housing when the inserter device is activated for insertion. The moveable member provides a usage indicator upon movement. For example, certain inserter devices may include a retracting member— as in a sharp carrier or "shuttle"— for retracting an introducer sharp (which may alternatively be referred to as a "needle") or other means. Movement of the retraction member may activate a visual cue visible from the exterior of the housing without opening the housing.

[0011] In one embodiment, the insertion device incorporates a lens on a surface of its housing. The lens may snap or press fit in place, may be integrally molded, or otherwise retained in place. The lens displays a use visual in response to the use of the inserter. For example, prior to actuating the inserter device to insert a medical device coupled thereto into the body of a recipient of the medical device, an un-used or ready-to-use indicator may be evident through the lens from the exterior of the inserter housing. In certain embodiments, a colored sharp and/or sharp carrier (e.g., red) is set within the inserter mechanism so that the lens on a user- visible surface of the housing creates a focal point that does not allow the sharp carrier to be seen (or be clearly seen) from the outside of the housing prior to actuation of the inserter. As such, the lens may have a pre-actuation, e.g., a pre- firing, visual state. This pre-actuation visual state may have a color or may have no color (e.g., may be void of color), but in any event is a visual state that differs from a post- actuation visual state. Upon actuating the inserter to advance the sharp and sharp-coupled medical device to a distal position so that at least a portion of the sharp projects forward and out of the distal end of the inserter, and subsequent sharp retraction, the sharp and/or sharp carrier is moved into focus of the lens to provide a post-actuation indicator that differs from the pre-actuation indicator. The sharp carrier may press against the lens in certain embodiments to directly contact the lens, or may be spaced apart a distance. In any event, at least a part of it will be easily visible by the user from outside the housing. In other words, the lens of the inserter housing will reveal a visual usage indicator that is produced by the actuation of the inserter. For example, in some embodiments, the user will view the sharp carrier as a large red (or other color, or lack of color) or other element on the top of the housing. Any interior- inserter housing element(s) may be moved into focus of the lens to provide a visual usage indicator, where a sharp and/or needle sharp are described as non-limiting examples of movable inserter members that may be used.

[0012] In another embodiment, the inserter housing incorporates a "light pipe" rather than a lens. A clear acrylic rod can be used for such purposes. The light pipe may have a first end at a first location of the inserter housing (e.g., a side) that is positioned to interface with light from the exterior of the housing, and a second end at a second location of the inserter housing (e.g., at the top of the housing). The sharp carrier of the inserter, or other inserter interior member(s), may have a color or visual image or a surface that reflects light, e.g., in a particular color. The light pipe may funnel light from the first location of the housing to the second location of the housing for viewing. In the pre-actuation state, the light pipe is configured to funnel light to a viewing area exterior of the housing to indicate non usage. Upon actuation of the inserter device, the sharp and/or sharp carrier or any other element that moves within the inserter moves to block the light pipe so as to be indicative of use activity by obstructing from the light transmitting element. Alternatively, the light pipe can be un-blocked during actuation from a blocked pre-actuation state. In any event, the "blocking member" therefore blocks light from the light transmitting element to indicate device usage, and may itself have a color or image that, when in its blocking position, is revealed at the second location of the housing to indicate device usage. The same holds true for other embodiments of the disclosure: although the viewing activity is described in connection with movement of the sharp and/or sharp carrier, another element may serve such function. For example, in a pre-actuation mode, the sharp carrier is separated from the light pipe such that no color or image indication is apparent at the viewing location of the housing. After actuation of the inserter and upon retraction of the sharp back into the housing, the sharp carrier is positioned between the first end of the light pipe and a side of the housing. In this configuration, the light pipe directs reflected light from the sharp carrier, e.g., a colored sharp carrier (or portion thereof), to the top of the housing, creating a post-actuation indicator such as a colored dot or image, visible from the exterior of the housing.

[0013] Yet another embodiment incorporates a ring of clear plastic at a surface of the inserter housing, e.g., the top of the inserter housing. Either the housing or another internal feature is opaque and obscures the user from being able to see the colored sharp carrier (or other internal housing component) prior to firing the inserter. Upon firing of the inserter causing retraction of the sharp and/or sharp carrier or movement of an internal housing component, the colored sharp or sharp carrier registers with the clear plastic ring in the housing— thus giving the appearance of turning the clear plastic ring into a colored ring, which is clearly visible to the user from the exterior of the housing.

[0014] A further embodiment incorporates a deformable member that assumes a pre- actuation form and assumes a deformed post-actuation form in response to use of the inserter, such as a low durometer (e.g., 20-70 Shore A), brightly colored silicone rubber (or other malleable material) to a surface of the sharp carrier or other interior-inserter housing component. Upon actuation of the inserter causing retraction of the sharp and/or sharp carrier, the silicone rubber of the carrier is pressed against a viewing window of the housing— thus flattening the silicone rubber and creating an enlarged and obvious area of colored material for the user to see through an opposing window.

[0015] In still another embodiment, an existing or additional component of an inserter is held inside the inserter device in a fixed position prior to use, but which becomes loosely constrained or altogether unconstrained inside the device in response to use of the inserter. This component can rattle when the device is shaken, thus providing a tactile and/or audible usage indication without the need to open the housing to determine usage. In a related embodiment, a component or system within the device may be designed to intentionally break upon use. The resulting "loose" part provides an audible cue when the device is shaken. Cue(s) aside, either such approach may prevent the device from functioning for any type of re-use.

[0016] Still further, upon review of the subject disclosure, those with skill in the art may appreciate other variations within the spirit or scope of the subject disclosure. The appended claims are intended to cover such variations directly or by way of equivalents. Unless expressly excluded by virtue of the subject claim language, all such equivalents are meant to be captured irrespective of any specific recital herein. Aspects of the present disclosure include the subject devices, kits they define and in which they are included, and their methods of use and manufacture.

BRIEF DESCRIPTION OF THE DRAWINGS

[0017] A detailed description of various aspects, features, and embodiments of the subject matter described herein is provided with reference to the accompanying drawings, which are briefly described below. The drawings are illustrative and may or may not be drawn to scale, with the possibility of some components and features being exaggerated for clarity.

Similar components may be numbered identically or not. The drawings illustrate various aspects and features of the present subject matter and may illustrate one or more embodiment(s) or example(s) of the present subject matter in whole or in part.

[0018] Figs. 1A-1C are perspective views illustrating features and the operation of an inserter and applied medical device;

[0019] Figs. 2A and 2B are section views of an embodiment employing a sidelight or a ring-window for indication of use before and after actuation;

[0020] Figs. 3A and 3B are section views of an embodiment employing a lens for indication of use before and after actuation;

[0021] Figs. 4A and 4B are section views of an embodiment employing a light pipe for indication of use before and after actuation; and

[0022] Figs. 5A and 5B are section views of an embodiment employing a compressible button for indication of use.

DETAILED DESCRIPTION

[0023] Exemplary embodiments of the present disclosure are described below. Reference is made to these examples in a non-limiting sense. They are provided to illustrate more broadly applicable aspects of the present disclosure. Various changes may be made to the disclosure described and equivalents may be substituted without departing from the true spirit and scope of the disclosure. In addition, many modifications may be made to adapt a particular situation, material, composition of matter, process, process act(s) or step(s) to the objective(s), spirit or scope of the present disclosure. All such modifications are intended to be within the scope of the claims made herein.

[0024] The present disclosure is directed to medical device inserters. Inserters include a housing having an interior with internal insertion components therein, and a use indicator. The inserters can include a factory-loaded medical device for insertion, or can be loaded with a medical device by a user prior to insertion. Inserters can be configured for manual medical device insertion or automatic or semi-automatic medical device insertion. An inserter housing includes an audio and/or visual and/or tactile and/or physical use indicator that is indicated in response to use of the inserter. By indicating a user feature, it can be determined if the inserter has been used or "fired", thereby obviating the need to open the inserter to determine use, which can breach sterility of the inserter. [0025] Turning to Figs. 1A and IB, inserter assembly 204 having housing 210 is placed at an application site 62 and actuated, e.g., pushed down firmly, to effect on body medical device 230 application. On body medical device 230 can be any medical device requiring application to the body of a user. In certain embodiments, the medical device includes an in vivo analyte (e.g., glucose and/or ketone) sensor configured for at least partial insertion into the body of a user. For example, an in vivo sensor may be transcutaneously positioned using an inserter so that a distal end resides in the body and a proximal end resides above, e.g., for attachment to electrical componentry. An in vivo sensor may be coupled or coupleable to an electronics unit (e.g., integrated with) that is temporarily attached to a skin surface. As such, an inserter may insert a sensor or a sensor and a communications unit. After use of inserter 204, it is removed from the application site. In certain embodiments, as illustrated in Fig. 1C, information from the inserted medical device, e.g., analyte levels detected by the inserted sensor, is transmitted over a communication link such as a wireless communication link "WL" to a user interface device 232 (referred to alternatively as a "reader" or "receiver unit" or "receiver device", or in some contexts, depending on the usage, as a "display unit," "handheld unit," or "meter"). Relevant information is presented on the unit display 234.

[0026] Figs. 2A and 2B are partial section views of an embodiment employing a viewing port for indication of use before and after inserter actuation. In the figures, the housing portion 210 of an inserter 204 is shown, along with a sharp carrier or shuttle 300 operatively associated with an introducer sharp 302. The viewing port 206 may include a clear ring of plastic between opaque sections adjacent thereto. The ring may be about 1 to 3 mm in height. Alternatively, viewing port(s) may include one or more bands subtending a small (e.g., 10-30 degree arc) or one or more dots (e.g., 1-3 mm diameter disk-shaped or square windows). In any case, as used herein the term "viewing port" refers to a window or window-like feature in a side of an inserter housing. However, the position of the window and the construction and shape of the housing may vary without departing from the spirit and scope of inventive aspects described herein.

[0027] Regardless of the terminology used, when inserter assembly 204 is viewed from the side (note the "eye's" perspective) before use, no usage feature is visible at or through the viewing port(s) to indicate that the inserter has been used. Rather, only the neutral or color of the opposite-side housing wall will be visible looking through the viewing port feature(s). However, after use as shown in Fig. 2B (as indicated by sharp 302 retraction with/by sharp carrier or shuttle 300) the sharp carrier (or another associated/related feature) is visible through the viewing port as it is moved into registration with the viewing port. It may simply be visible as colored band, image, text, or otherwise.

[0028] As specifically noted above, the carrier may be colored (e.g., red) to give the impression that the clear viewing port is red when the device is not suitable for use.

Instead of being clear, the viewing port may instead be colored green indicating ready for use until the sharp carrier moves to a proximal position as shown in Fig. 3B. Of course, other pre- and post-use colors may be used.

[0029] The ring-window or viewing port may be created by molding the inserter housing using transparent or translucent resin and selectively applying paint such that the ring- window is void of paint, while the remainder of the inserter housing is painted.

Alternatively, the ring-window may be a separate, transparent or translucent component that is either co-molded or insert-molded during manufacture of the housing. This would allow the inserter housing to be molded using any number of non-transparent or non- translucent materials. In both alternatives, the ring-window remains an integral component of the inserter housing and does not interfere with the sterile barrier created by the housing and cap assembly.

[0030] In certain embodiments, the housing may be molded with a transparent or a translucent material and then selectively painted or in-mold decorated to leave a ring of clear transparent or translucent material at the desired location. In certain embodiments, the ring-window may be a separate component that is snapped, glued, or ultras onically welded into place at the desired location.

[0031] Open windows (unsealed) may be created by adding features to the cavities of an injection-molding tooling. Closed windows (sealed) may be created by performing a double-shot injection- molding process to an open window design, or bonding a separate translucent part to an open window, or

molding the entire housing out of a translucent material, and texturing the surfaces except for the windows.

[0032] Figs. 3A and 3B are partial section views of an inserter 204 in which a window 208 in the form of a lens for indication of use before and after inserter actuation is included in housing 210. As referenced above, the lens element may be integrally formed in the housing (e.g., during injection molding). In any case, the lens is shaped to provide a focal point "F" nearby its distal surface (i.e., relative to the travel "T" of sharp carrier 300). Positioned past the focal point, the carrier structure— and even its color— is badly blurred or otherwise not apparent upon visual inspection. However, upon use of the device and retraction of the sharp carrier up to or adjacent to the focal point as shown in Fig. 3B, the carrier becomes clearly visible in color and/or even as to its feature. For instance, it may bear an image or text such as "Used" that comes into focus for a user when in such a state.

[0033] Figs. 4A and 4B are section views of an embodiment employing an internal housing light pipe 214 for indication of use before and after actuation. A proximal portion of the light pipe operates as a window 208 for viewing, wherein a distal portion 216 may be positioned, e.g., angled or beveled, to direct reflected light at an indicator feature 218. When adjacent to the light pipe as in Fig. 4B, the feature (or just its image or color) becomes visible indicating that the inserter 204 has been used.

[0034] Figs. 5A and 5B are section views of an embodiment employing a compressible button or plug 220 for indication of use. As shown in Fig. 5A, the button is uncompressed in the pre-actuation state. It may be small and cylindrical in shape in certain embodiments. Upon retraction and compression by sharp carrier 300 as shown in Fig. 5B, the (optimally) elastomeric body is compressed. For example, it may take on a "pancake" form 220', or other usage form. The shape change may be viewed through an adjacent window 208.

[0035] In addition, or in the alternative, other features indicating use may be incorporated in inserter 204 as illustrated in Figs. 5A and 5B. In Fig. 5A, a rail 222 within housing 210 to guide sharp carrier 300 may terminate or be undercut so that the carrier is not fully supported at the proximal extent of its travel. So-configured, the carrier can shake or "rattle" within the housing when perturbed to give an audible indication of use. In Fig. 5B, a break-off tab may be incorporated at 224 or elsewhere that rattles within the inserter housing after device use.

[0036] As used herein and in the appended claims, the singular forms "a", "an", and "the" include plural referents unless the context clearly dictates otherwise. Reference to a singular item includes the possibility that there is a plurality of the same items present. In other words, use of the articles allow for "at least one" of the subject item in the description above as well as the claims below. When two or more items (for example, elements or processes) are referenced by an alternative "or", this indicates that either could be present separately or any combination of them could be present together except where the presence of one necessarily excludes the other or others.

[0037] As will be apparent to those of skill in the art upon reading this disclosure, each of the individual embodiments or variations described and illustrated herein has discrete components and features which may be readily separated from or combined with the features of any of the other several embodiments without departing from the scope or spirit of the present disclosed subject matter. Any recited method can be carried out in the order of events recited, or in any other order which is logically possible. Likewise, it is contemplated that any particular feature of the inventive variations described may be set forth and claimed independently, or in combination with any one or more of the features described herein. As such, the claims may be drafted to exclude any optional element. Accordingly, this statement is intended to serve as antecedent basis for use of such exclusive terminology as "solely," "only" and the like in connection with the recitation of claim elements, or use of another type of "negative" limitation.

[0038] Without the use of such exclusive terminology, the term "comprising" in the claims shall allow for the inclusion of any additional element irrespective of whether a given number of elements are enumerated in the claim, or the addition of a feature could be regarded as transforming the nature of an element set forth in the claims. Except as specifically defined herein, all technical and scientific terms used herein are to be given as broad a commonly understood meaning as possible while maintaining claim validity.

[0039] Where a range of values is provided, it is understood that each intervening value between the upper and lower limit of that range and any other stated or intervening value in that stated range, is encompassed within the disclosed subject matter. Every range stated is also intended to specifically disclose each and every "subrange" of the stated range. That is, each and every range smaller than the outside range specified by the outside upper and outside lower limits given for a range, whose upper and lower limits are within the range from said outside lower limit to said outside upper limit (unless the context clearly dictates otherwise), is also to be understood as encompassed within the disclosed subject matter, subject to any specifically excluded range or limit within the stated range. Where a range is stated by specifying one or both of an upper and lower limit, ranges excluding either or both of those stated limits, or including one or both of them, are also

encompassed within the disclosed subject matter, regardless of whether or not words such as "from", "to", "through", or "including" are or are not used in describing the range.

[0040] Although any methods and materials similar or equivalent to those described herein can also be used in the practice or testing of the present disclosed subject matter, this disclosure may specifically mention certain exemplary methods and materials. All publications mentioned in this disclosure are, unless otherwise specified, incorporated herein by reference for all purposes, including without limitation to disclose and describe the methods and/or materials in connection with which the publications are cited. [0041] The publications discussed herein are provided solely for their disclosure prior to the filing date of the present application. Nothing herein is to be construed as an admission that the present disclosed subject matter is not entitled to antedate such publication by virtue of prior disclosure. Further, the dates of publication provided may be different from the actual publication dates, which may need to be independently confirmed.

[0042] Nothing contained in the Abstract or the Summary should be understood as limiting the scope of the disclosure, however, they may be cited for the purpose of claim support. The Background, Abstract and the Summary are provided for bibliographic and convenience purposes and due to their formats and purposes should not be considered comprehensive.

[0043] The breadth of the present disclosure is not to be limited to the examples provided and/or the subject specification, but rather only by the scope of the claim language.

Although the foregoing disclosure has been described in detail for purposes of clarity of understanding, it is contemplated that certain modifications may be practiced within the scope of the appended claims.