Disposable medical device introduction system

A disposable medical introduction system including a medical device and a disposable inserter. The disposable inserter includes a carrier to receive the medical device. The carrier includes at least one annular projection. The disposable inserter includes a retractor received within the at least one annular projection and movable relative to the at least one annular projection. The retractor has at least one retaining arm. The disposable inserter includes a needle cartridge coupled to the retractor that includes an insertion needle. The at least one retaining arm cooperates with the needle cartridge to maintain the insertion needle in a first, extended state. A movement of the retractor relative to the at least one annular projection releases the at least one retaining arm to move the insertion needle from the first, extended state to a second, retracted state.

TECHNICAL FIELD

The present technology is generally related to medical devices, such as a disposable medical device introduction system for use with a medical device associated with a user, such as a physiological characteristic sensor or an infusion unit. More particularly, embodiments of the subject matter relate to a disposable medical device introduction system for a physiological characteristic sensor or an infusion unit, and a disposable inserter for coupling the physiological characteristic sensor or the infusion unit to a user.

BACKGROUND

Sensors may be employed in the treatment of or monitoring of various medical conditions. Thin film electrochemical sensors are used to test analyte levels in patients or users. More specifically, thin film sensors have been designed for use in obtaining an indication of blood glucose (BG) levels and monitoring BG levels in a diabetic user, with the distal segment portion of the sensor positioned subcutaneously in direct contact with extracellular fluid. Such readings can be especially useful in adjusting a treatment regimen which typically includes regular administration of insulin to the user. A glucose sensor of the type described above may be packaged and sold as a product, such as a continuous glucose monitor, which is adhered to the patient during use via an adhesive skin patch.

In addition, certain diseases or conditions may be treated, according to modern medical techniques, by delivering a medication or other substance to the body of a user, either in a continuous manner or at particular times or time intervals within an overall time period. For example, diabetes is commonly treated by delivering defined amounts of insulin to the user at appropriate times. Some common modes of providing insulin therapy to a user include delivery of insulin through manually operated syringes and insulin pens. Other modern systems employ programmable fluid infusion devices (e.g., insulin pumps) to deliver controlled amounts of insulin to a user. In certain instances, these fluid infusion devices require an insertion set, such as an infusion set that includes an infusion unit, to be coupled to the body of a user for the delivery of the insulin. Generally, the infusion set is coupled to the fluid infusion device via hollow tubing, which provides a fluid flow path from the fluid infusion device to the user via the infusion unit. Typically, the infusion unit requires a portion of a cannula, for example, to be inserted under the skin of the user to deliver the controlled amounts of insulin from the fluid infusion device to the user via the infusion unit.

In order to insert the glucose sensor into the user or to insert the cannula into the user, an inserter may be used, which includes a needle to puncture the skin of the user at the same time the glucose sensor or the cannula is introduced. As the inserter employs the use of a needle, the inserter is unable to be conveniently disposed of, and rather, must be disposed of in a biohazard and/or sharps container or shipped to a medical supplier for proper disposal.

Accordingly, it is desirable to provide a disposable medical device introduction system, which includes a disposable inserter for coupling a physiological characteristic sensor, such as a continuous glucose monitor, or an infusion unit, to an anatomy of a user. Furthermore, other desirable features and characteristics will become apparent from the subsequent detailed description and the appended claims, taken in conjunction with the accompanying drawings and the foregoing technical field and background.

BRIEF SUMMARY

The subject matter of this disclosure generally relates to a disposable medical device introduction system that includes a disposable inserter for coupling a medical device, such as a physiological characteristic sensor, for example, a continuous glucose sensor, or an infusion unit, to a user.

According to various embodiments, provided is a disposable inserter for a medical device. The disposable inserter includes a carrier to receive the medical device. The carrier includes at least one annular projection. The disposable inserter includes a retractor received within the at least one annular projection and movable relative to the at least one annular projection. The retractor has at least one retaining arm. The disposable inserter includes a needle cartridge coupled to the retractor that includes an insertion needle. The at least one retaining arm cooperates with the needle cartridge to maintain the insertion needle in a first, extended state. A movement of the retractor relative to the at least one annular projection releases the at least one retaining arm to move the insertion needle from the first, extended state to a second, retracted state.

Also provided according to various embodiments is a disposable medical device introduction system. The disposable medical device introduction system includes a medical device, and a disposable inserter. The disposable inserter includes a plunger defining an access opening enclosed by a removable access cover, and a carrier to receive the medical device. The carrier includes at least one annular projection, and the carrier is movable relative to the plunger. The disposable inserter includes a retractor received within the at least one annular projection and movable relative to the at least one annular projection. The retractor has at least one retaining arm. The disposable inserter includes a needle cartridge coupled to the retractor that includes an insertion needle. The at least one retaining arm cooperates with the needle cartridge to maintain the insertion needle in a first, extended state, and a movement of the retractor relative to the at least one annular projection releases the at least one retaining arm to move the insertion needle from the first, extended state to a second, retracted state. The needle cartridge is removable through the access opening.

DETAILED DESCRIPTION

As used herein, the term “axial” refers to a direction that is generally parallel to or coincident with an axis of rotation, axis of symmetry, or centerline of a component or components. For example, in a cylinder or disc with a centerline and generally circular ends or opposing faces, the “axial” direction may refer to the direction that generally extends in parallel to the centerline between the opposite ends or faces. In certain instances, the term “axial” may be utilized with respect to components that are not cylindrical (or otherwise radially symmetric). For example, the “axial” direction for a rectangular housing containing a rotating shaft may be viewed as a direction that is generally parallel to or coincident with the rotational axis of the shaft. Furthermore, the term “radially” as used herein may refer to a direction or a relationship of components with respect to a line extending outward from a shared centerline, axis, or similar reference, for example in a plane of a cylinder or disc that is perpendicular to the centerline or axis. In certain instances, components may be viewed as “radially” aligned even though one or both of the components may not be cylindrical (or otherwise radially symmetric). Furthermore, the terms “axial” and “radial” (and any derivatives) may encompass directional relationships that are other than precisely aligned with (e.g., oblique to) the true axial and radial dimensions, provided the relationship is predominantly in the respective nominal axial or radial direction. As used herein, the term “transverse” denotes an axis that crosses another axis at an angle such that the axis and the other axis are neither substantially perpendicular nor substantially parallel.

The following description relates to various embodiments of a disposable medical device introduction system, which includes a physiological characteristic sensor or an infusion unit, and a disposable inserter. The systems described herein enable the disposable inserter to be recycled or disposed of in the user's own home (or current location) without requiring a disposal in a biohazard and/or sharps container once the physiological characteristic sensor or infusion unit is coupled to the user. It should be noted that while the physiological characteristic sensor is described herein as being a continuous glucose monitor, it will be understood that the physiological characteristic sensor may comprise a variety of other sensors, such as cardiac monitors, body temperature sensors, EKG monitors etc., medical devices, and/or other components that are intended to be affixed to the body of a user. In addition, the fluid infusion device for use with the infusion unit of the infusion set may be used for infusing fluid into the body of a user. In certain embodiments, the infused medication fluid is insulin. In alternative embodiments, however, many other fluids may be administered through infusion such as, but not limited to, disease treatments, drugs to treat pulmonary hypertension, iron chelation drugs, pain medications, anti-cancer treatments, medications, vitamins, hormones, or the like. For the sake of brevity, conventional features and characteristics related to infusion system operation, insulin pump and/or infusion set operation, fluid reservoirs, and fluid syringes may not be described in detail here. Examples of infusion pumps and/or related pump drive systems used to administer insulin and other medications may be of the type described in, but not limited to: U.S. Patent Publication Nos. 2009/0299290 and 2008/0269687; U.S. Pat. Nos. 4,562,751; 4,678,408; 4,685,903; 5,080,653; 5,505,709; 5,097,122; 6,485,465; 6,554,798; 6,558,351; 6,659,980; 6,752,787; 6,817,990; 6,932,584; 7,621,893; 7,828,764; and 7,905,868; which are each incorporated by reference herein. Thus, while the non-limiting examples described below relate to a medical device used to treat diabetes (more specifically, a continuous glucose monitor or infusion unit associated with an infusion set), embodiments of the disclosed subject matter are not so limited.

Generally, the glucose sensor employed with the adhesive patch is a continuous glucose sensor of the type used by diabetic users. For the sake of brevity, conventional aspects and technology related to glucose sensors and glucose sensor fabrication may not be described in detail here. In this regard, examples of glucose sensors and their manufacturing may be of the type described in, but not limited to: U.S. Pat. Nos. 6,892,085, 7,468,033 and 9,295,786; and United States patent application number 2009/0299301 (which are each incorporated by reference herein). In addition, for the sake of brevity, conventional aspects and technology related to sensor inserters may not be described in detail here. In this regard, examples of sensor inserters may be of the type described in, but not limited to: U.S. Pat. No. 10,413,183 and U.S. application Ser. No. 16/892,854 filed on Jun. 4, 2020 (which are each incorporated by reference herein).

With reference toFIG.1,FIG.1is a perspective view of a disposable medical device introduction system100. In the example ofFIG.1, the disposable medical device introduction system100includes a physiological characteristic sensor assembly102and a disposable inserter104. Generally, with reference toFIG.2, the components of the physiological characteristic sensor assembly102are coupled together as a single unit. The physiological characteristic sensor assembly102and the disposable inserter104may be packaged together for use by a consumer or user. The disposable inserter104is in a first position inFIG.2.

The physiological characteristic sensor assembly102may comprise any suitable physiological characteristic sensor, such as a continuous glucose monitor, for use with the disposable inserter104, and thus, the physiological characteristic sensor assembly102will not be discussed in great detail herein. Briefly, the physiological characteristic sensor assembly102includes a physiological characteristic sensor106and an adhesive skin patch or adhesive patch108. The physiological characteristic sensor106includes a sensor electronics module (not shown), such as a wireless transmitter that communicates with a fluid infusion device (such as an infusion pump), a monitor device, or the like, which connects to the physiological characteristic sensor106after the insertion or deployment of a portion of the physiological characteristic sensor106in the body of the user. In certain embodiments, the physiological characteristic sensor106includes a glucose sensor110and a sensor housing112. It should be noted that the physiological characteristic sensor106is not limited to a glucose sensor, but rather, various other physiological characteristic sensors may be employed. The glucose sensor110may be provided as an integral part of the sensor housing112. The sensor housing112gives structural support to the glucose sensor110, and facilitates entry of the glucose sensor110into the body of the user. The glucose sensor110is an electrochemical sensor that includes the glucose oxidase enzyme, as is well understood by those familiar with glucose sensor technology. The glucose oxidase enzyme enables the glucose sensor110to monitor blood glucose levels in a diabetic patient or user by effecting a reaction of glucose and oxygen. Again, although certain embodiments pertain to glucose sensors, the technology described here can be adapted for use with any one of the wide variety of sensors known in the art. Generally, the glucose sensor110is positionable in subcutaneous tissue of the user by an insertion needle162of the disposable inserter104to measure the glucose oxidase enzyme.

The sensor housing112is coupled to the disposable inserter104and is coupled to the adhesive patch108. The sensor housing112may also feature electrical and physical interfaces and elements that accommodate the sensor electronics module, such as the wireless transmitter that communicates with the infusion pump, the monitor device, or the like. In certain embodiments, the sensor housing112is composed at least in part from a plastic material. For the embodiment described here, the bulk of the sensor housing112is formed as a molded plastic component. The sensor housing112may be formed from acrylonitrile butadiene styrene, nylon, an acrylonitrile butadiene styrene polycarbonate blend, polyvinyl chloride, polytetrafluoroethylene (PTFE), polypropylene, polyether ether ketone (PEEK), polycarbonate or the like.

The adhesive patch108is coupled to the sensor housing112and affixes the sensor housing112, and thus, the glucose sensor110, to an anatomy, such as the skin of the user. The adhesive patch108is contained within the disposable inserter104during packaging and shipping. The adhesive patch108may be composed of a flexible and breathable material with one or more adhesive layers, such as cloth, a bandage-like material, and the like. For example, suitable materials could include polyurethane, polyethylene, polyester, polypropylene, polytetrafluoroethylene (PTFE), or other polymers, to which one or more adhesive layers are applied.

With reference back toFIG.2, in various embodiments, the physiological characteristic sensor assembly102is coupled to the disposable inserter104for shipping and delivering the physiological characteristic sensor assembly102to the user. The disposable inserter104is manipulatable by a user to couple the glucose sensor110and the physiological characteristic sensor106to the user. With additional reference toFIG.3, the disposable inserter104includes a needle cartridge120, a plunger122, a first biasing member or insertion spring124, a frame126, a retractor128, a second biasing member or retraction spring130, a retainer132, a carrier134, a magnet136and a cap138. In this example, the cap138includes a membrane140, as will be discussed further herein.

The needle cartridge120is movable relative to the plunger122to insert the glucose sensor110into the anatomy. With reference toFIG.4, the needle cartridge120includes a needle inserter150, a third biasing member or third spring152and a cartridge housing154. The needle inserter150includes a needle carrier160and an insertion needle162. The needle carrier160is overmolded onto the insertion needle162. The needle carrier160is substantially cylindrical. The needle carrier160includes a first carrier end164opposite a second carrier end166and defines a cross-bore168. The first carrier end164includes at least one contact surface, and in this example, includes opposed contact surfaces defined as chamfered surfaces170. The chamfered surfaces170define a first contact surface for the cartridge housing154, as will be discussed. Generally, the chamfered surfaces170are defined on opposed sides of the needle carrier160, however, the chamfered surfaces170may comprise a single surface defined about a perimeter of the first carrier end164, if desired. The second carrier end166is coupled to the insertion needle162. The second carrier end166may include a collar172that extends outward from the second carrier end166and surrounds a portion of the insertion needle162. The collar172is a spring guide for the third spring152. The cross-bore168is defined through the needle carrier160from a first side to a second side to as to extend along an axis that is transverse or oblique to an axis defined by the insertion needle162. The cross-bore168provides for ease of manufacturing by enabling the needle carrier160to be molded onto the insertion needle162. The insertion needle162is generally a stainless steel needle, which extends for a distance beyond a distal end of the glucose sensor110to couple the glucose sensor110to the anatomy (FIG.2).

The third spring152may be a helical coil spring, which is composed of a suitable biocompatible material, such as a spring steel that is wound to form the third spring152. The third spring152is received between the needle carrier160and a second cartridge end174of the cartridge housing154(FIG.5). The third spring152is held in compression by the needle carrier160to maintain the insertion needle162in a first extended state (shown inFIG.5), and once released by the needle carrier160, expands to move the needle carrier160relative to the cartridge housing154and within the cartridge housing154, thereby moving the insertion needle162to a second retracted state (shown inFIG.6) for disposal, as will be discussed further herein.

With reference toFIG.4, the cartridge housing154is substantially cylindrical, and extends along a cartridge longitudinal axis CL. The cartridge longitudinal axis CL is parallel to a longitudinal axis L of the disposable inserter104(FIG.2). The cartridge housing154is composed of a suitable polymer based material, including, but not limited to acrylonitrile butadiene styrene, nylon, an acrylonitrile butadiene styrene polycarbonate blend, polyvinyl chloride, polytetrafluoroethylene (PTFE), polypropylene, polyether ether ketone (PEEK), polycarbonate or the like. The cartridge housing154includes a cap175, a first cartridge end176opposite the second cartridge end174, a cartridge body177that interconnects the first cartridge end176with the second cartridge end174, at least one lock arm178and at least one coupling tab180. The cartridge housing154also defines a cartridge bore182that extends through the cartridge body177from the first cartridge end176to the second cartridge end174.

The cap175is coupled to the cartridge body177at the first cartridge end176to enclose the cartridge bore182(FIG.6). The cap175is generally discretely formed from the cartridge body177, and is coupled to the first cartridge end176via ultrasonic welding, adhesives, etc. The cap175provides a stop for a travel of the needle carrier160within the cartridge bore182(FIG.6). In this regard, the cap175includes a first exterior surface184opposite a second interior surface186. The first exterior surface184is substantially planar or flat. The second interior surface186is defined along a cap projection175athat extends into the cartridge bore182to enclose the cartridge bore182(FIG.9). The second interior surface186provides a stop surface for further advancement of the needle carrier160within the cartridge bore182. The second cartridge end174includes a third interior surface188opposite a fourth exterior surface190, and defines a bore192that extends through the third interior surface188and the fourth exterior surface190. The third interior surface188provides a seat for the third spring152, and includes a guide collar189. The guide collar189serves to guide a movement of the third spring152. The fourth exterior surface190is substantially planar or flat. The bore192is defined through the third interior surface188and the fourth exterior surface190to enable the insertion needle162to pass through the bore192into the cartridge bore182when the insertion needle162is in the second, retracted state (shown inFIG.6).

The cartridge body177is substantially cylindrical, and interconnects the first cartridge end176with the second cartridge end174. The at least one lock arm178and the at least one coupling tab180are integrally formed with the cartridge housing154. In certain embodiments, each of the at least one lock arm178and the at least one coupling tab180are integrally formed with the cartridge body177. With reference toFIG.8, the at least one lock arm178includes two lock arms178a,178b. The lock arms178a,178bextend from the first cartridge end176toward the second cartridge end174. The lock arms178a,178bare opposed from each other about a perimeter or circumference of the cartridge body177. Each of the lock arms178a,178binclude a first lock arm end194and a second lock arm end196interconnected by an arm198. Each of the lock arms178a,178bare cantilevered relative to the cartridge body177, and thus, recesses179a,179bmay be defined about the second lock arm end196and the arm198to enable the second lock arm end196to move relative to the cartridge body177. As will be discussed, a movement of the lock arms178a,178brelative to the cartridge body177results in a movement of the insertion needle162from the first, extended state (FIG.5) to the second, retracted state (FIG.6).

The first lock arm end194is integrally formed with the cartridge body177, and extends along an axis parallel to the cartridge longitudinal axis CL. The second lock arm end196has a bulbous portion200, which defines a first contact surface202and a second contact surface204. The first contact surface202is defined so as to extend a distance beyond an exterior surface177aof the cartridge body177when the insertion needle162is in the first extended state (FIG.8) to contact a portion of the retractor128. In certain embodiments, the first contact surface202is a flat angled surface, which is defined along an exterior surface196aof the second lock arm end196. It should be noted that the first contact surface202may have other configurations, if desired. Generally, the first contact surface202is angled to correspond with an angle of the portion of the retractor128to provide surface to surface contact.

The second contact surface204is defined diagonally opposite from the first contact surface202. The second contact surface204is defined so as to be positioned within the cartridge bore182to contact the chamfered surfaces170of the needle carrier160when the insertion needle162is in the first extended state. In certain embodiments, the second contact surface204is a flat angled surface, which is defined along an interior surface196bof the second lock arm end196. It should be noted that the second contact surface204may have other configurations, if desired. Generally, the first contact surface202and the second contact surface204each extend along an axis, and the axes of the first contact surface202and the second contact surface204are parallel to each other and transverse or oblique to the cartridge longitudinal axis CL. The second contact surface204is angled to correspond with the angle of the chamfered surfaces170to provide surface to surface contact between the respective one of the lock arms178a,178band the respective one of the chamfered surfaces170. The arm198interconnects the first lock arm end194and the second lock arm end196. The arm198is surrounded by the respective recess179a,179bsuch that the arm198is a cantilevered beam.

With reference toFIG.9, the at least one coupling tab180includes two coupling tabs180a,180b. The coupling tabs180a,180bare defined proximate the second cartridge end174. The coupling tabs180a,180bare opposed from each other about a perimeter or circumference of the cartridge body177. Each of the coupling tabs180a,180binclude a first tab end206and a second tab end208interconnected by a coupling arm210. Each of the coupling tabs180a,180bare cantilevered relative to the cartridge body177, and thus, recesses211a,211bmay be defined about the second tab end208and the coupling arm210to enable the second tab end208to move relative to the cartridge body177. Generally, the recesses211a,211bare defined such that the second tab end208is spaced apart from the third interior surface188of the second cartridge end174. As will be discussed, a movement of the coupling tabs180a,180brelative to the cartridge body177enables a removal of the needle cartridge120from the plunger122.

The first tab end206is integrally formed with the cartridge body177, and extends along an axis parallel to the cartridge longitudinal axis CL. The second tab end208has an angled projection212, which engages with a portion of the retractor128. The projection212is substantially triangular in shape, and is defined so as to extend a distance beyond the exterior surface177aof the cartridge body177when the insertion needle162is in the first, extended state (FIG.8) to contact a portion of the retractor128. The coupling arm210interconnects the first tab end206and the second tab end208. The coupling arm210is surrounded by the respective recess211a,211bsuch that the coupling arm210is a cantilevered beam.

With reference back toFIG.3, the plunger122is composed of a biocompatible polymer, and may be molded, cast, printed, etc. The plunger122surrounds the frame126, and includes a plurality of threads220defined about a surface of the plunger122adjacent to a second, bottom end122b. The threads220removably couple the cap138to the plunger122, as will be discussed. The plunger122is shaped to correspond to the shape of the physiological characteristic sensor106(FIG.2) so that the user intuitively knows the position and orientation of the physiological characteristic sensor106when the disposable inserter104is used to couple the physiological characteristic sensor106to the anatomy. This enables the user to position the disposable inserter104at a location by feel, without having to see the insertion site, such as a back of an arm, for example. In certain embodiments, a first, top end122aof the plunger122defines an access opening224and a removable cover or access cover226, which enables a removal of the needle cartridge120from the disposable inserter104.

With reference toFIG.10, the access opening224is shown in greater detail. InFIG.10, the access cover226is removed from the plunger122and the needle cartridge120is shown removed from the disposable inserter104after a deployment of the physiological characteristic sensor106onto the anatomy. As shown, in this example, the access opening224includes a central circular portion227and a pair of opposed rectangular slots229. The central circular portion227has a diameter D2that is different than, and in this example, larger than, a diameter D1of the cartridge body177. The difference in the diameters D1, D2enables the cartridge body177to pass through the access opening224. The opposed rectangular slots229are in communication with the central circular portion227to enable the coupling tabs180a,180bto pass through the access opening224. Generally, the coupling tabs180a,180bextend beyond a perimeter or circumference of the cartridge body177for a distance D3, which is different and less than a distance D4defined by the opposed rectangular slots229. The distance D3is also different, and greater than, the diameter D1(FIG.9). Thus, generally, the access opening224enables the removal of the needle cartridge120from the disposable inserter104. It should be noted that the access opening224may be configured or shaped differently, if desired, based on a shape of the needle cartridge120.

The access opening224may be recessed relative to a surface122cof the plunger122at the first end122aso as to be disposed below a plane defined by the surface122c. In this example, a recess228is defined at the first end122ato surround the access opening224, and the access opening224is defined through the recess228. An inner rib230is defined about the access opening224to form a channel232between a sidewall of the recess228and the inner rib230. The inner rib230is defined so as to be rectangular in this example, but the inner rib230may have any desired shape. The inner rib230extends outwardly from the recess228and is substantially coplanar with the surface122c. The channel232is generally defined so as to be rectangular and to substantially surround the access opening224. The channel232receives an adhesive, for example, to couple the removable access cover226(FIG.1) to the plunger122. It should be noted that in this example, the recess228also defines a recessed notch234that is spaced apart from the inner rib230. The recessed notch234is spaced apart from the inner rib230to ensure that a minimal amount or no adhesive flows into the recessed notch234. This ensures that a portion of the removable access cover226is unadhered to the plunger122, which enables a user to insert a finger into the recessed notch234to grasp the access cover226and peel the access cover226from the plunger122.

With reference toFIG.1, the access cover226is shown attached to the plunger122. In this example, the access cover226is substantially rectangular and includes a pull-tab226a, however, the access cover226may have any desired shape that corresponds with the needle cartridge120and the access opening224. The access cover226may be composed of any suitable material, and in certain embodiments, the access cover226is composed of a gas permeable polymeric material, such as Tyvek® manufactured by DuPont™ of Midland, Mich., which is coupled to the plunger122along the surface122cof the recess228, via adhesives, ultrasonic welding, heat bond, etc., for example. The access opening224is covered by the access cover226. The access opening224cooperates with the access cover226to enable the sterilization of the physiological characteristic sensor106and the needle cartridge120contained within the disposable inserter104. Generally, a seal is formed by the access cover226about the access opening224and during a sterilization procedure, the sterilization gas may penetrate into and out of the disposable inserter104, via the access opening224, and sterilize the physiological characteristic sensor106and an interior of the disposable inserter104.

With reference back toFIG.2, the plunger122also defines a first inner guide surface238and a second inner guide surface240. Each of the first inner guide surface238and the second inner guide surface240extend inward from an inner surface of the plunger122. In this example, each of the first inner guide surface238and the second inner guide surface240extend from the first end122atoward the second end122b. In certain embodiments, the first inner guide surface238includes a slot that cooperates with a rail242defined within the retractor128(FIG.3). The engagement of the rail242with the slot guides the retractor128toward the first end122aof the plunger122to facilitate the removal of the needle cartridge120after deployment of the physiological characteristic sensor106. The second inner guide surface240cooperates with the carrier134to guide the carrier134during deployment of the physiological characteristic sensor106. The plunger122also includes a plurality of projections244that extend radially inward spaced apart about an interior periphery of the plunger122. The projections244cooperate with slots246defined in the frame126. Generally, the projections244and the slots246cooperate to a guide a movement of the plunger122relative to the frame126. The plunger122also includes frame projections247. The frame projections247extend radially inward and are defined about a perimeter of the plunger122. As will be discussed, the frame projections247cooperate with the frame126to release the physiological characteristic sensor106when the disposable inserter104is in a second position.

The insertion spring124is a helical coil spring, which is composed of a suitable biocompatible material, such as a spring steel that is wound to form the insertion spring124. The insertion spring124is received between the second inner guide surface240of the plunger122and a surface134aof the carrier134. Generally, the insertion spring124expands as the carrier134moves toward a second, bottom end126bof the frame126to couple the physiological characteristic sensor106to the user and exerts a spring force F1along the longitudinal axis L to move the carrier134toward the bottom end134bof the frame126for deployment of the physiological characteristic sensor106.

The frame126is received within the plunger122. Generally, the frame126extends a distance beyond the plunger122. The frame126is composed of a biocompatible polymer, and may be molded, cast, printed, etc. With reference toFIG.3, the frame126includes a first frame portion250and a second frame portion252. The slots246are defined in the first frame portion250and extend from a top surface126aof the frame126to the second frame portion252. The second frame portion252surrounds the carrier134such that the physiological characteristic sensor106(FIG.2) is positioned within the second frame portion252of the frame126. With reference toFIG.14, the second frame portion252includes at least one or a plurality of ribs254. The ribs254are spaced apart about the inner perimeter of the frame126, and extend for a distance to engage with the retainer132as shown. In a first position, as shown inFIG.2, the ribs254engage with the retainer132to retain the physiological characteristic sensor106. In a second position, the ribs254are released, via contact between the frame projections247of the plunger122and the ribs254, which causes the retainer132to release the physiological characteristic sensor106for deployment onto the anatomy.

The retractor128is coupled to a second annular projection256of the carrier134. The retractor128is composed of a biocompatible polymer, and may be molded, cast, printed, etc. With reference toFIG.11, the retractor128includes a first portion260, a second portion262and defines a bore263that extends through the first portion260and the second portion262. The needle cartridge120is received within the bore263. The first portion260has a greater diameter than the second portion262. The first portion260includes one or more guide projections264, which are spaced apart about a perimeter of the first portion260. The guide projections264contact a second annular projection256of the carrier134. The first portion260may also include a locating projection261, which assists with assembly of the retractor128to the carrier134. The first portion260also includes at least one retaining arm266. With reference toFIG.12, the retractor128is shown coupled to the needle cartridge120and the retraction spring130. In this example, the at least one retaining arm266includes two retaining arms266a,266b. The retaining arms266a,266bextend from a first end260atoward a second end260bof the first portion260. Generally, the retaining arms266a,266bare defined so as to be spaced apart from the second portion262by a distance D5so that the retaining arms266a,266bengage with the lock arms178a,178b. The retaining arms266a,266bare opposed from each other about a perimeter or circumference of the first portion260. Each of the retaining arms266a,266binclude a first retaining arm end268and a second retaining arm end270interconnected by an arm272. Each of the retaining arms266a,266bare cantilevered relative to the first portion260, and thus, recesses271a,271b(FIG.11) may be defined about the second retaining arm end270and the arm272to enable the second retaining arm end270to move relative to the first portion260of the retractor128. As will be discussed, a movement of the retaining arms266a,266brelative to the first portion260of the retractor128results in a movement of the insertion needle162from the first, extended state (FIG.5) to the second, retracted state (FIG.6).

The first retaining arm end268is integrally formed with the first portion260, and extends along an axis parallel to a retractor longitudinal axis RL. The second retaining arm end270has a triangular portion274, which defines a retaining contact surface276. The triangular portion274extends inward into the bore263to contact the first contact surface202of the respective lock arm178a,178bwhen the insertion needle162is in the first extended state (FIG.8). In certain embodiments, the retaining contact surface276is a flat angled surface, which is defined along one side of the triangular portion274. Generally, the retaining contact surface276is angled to correspond with the angle of the first contact surface202of the lock arms178a,178bto provide surface to surface contact. It should be noted that the retaining contact surface276may have other configurations, if desired. Generally, the retaining contact surface276extends along an axis, which is transverse or oblique to the retainer longitudinal axis RL. The arm272interconnects the first retaining arm end268and the second retaining arm end270. The arm272is surrounded by the respective recess271a,271bsuch that the arm272is a cantilevered beam.

The second portion262is coupled to the cartridge housing154of the needle cartridge120. The diameter of the second portion262is sized such that the retraction spring130is positioned between the first portion260and the carrier134so as to surround the second portion262, as shown inFIG.2. With reference toFIG.13, the second portion262defines at least one internal slot or opposed internal slots280. The internal slots280slidably receive the second tab end208of the respective coupling tabs180a,180b. The internal slots280include a stop surface280a, which limits an advancement of the needle cartridge120within the retractor128. Generally, the internal slots280guide the needle cartridge120during the deployment of the physiological characteristic sensor106(FIG.2) into the anatomy. Once the physiological characteristic sensor106(FIG.2) is deployed, the internal slots280enable the needle cartridge120to be removed or uncoupled from the retractor128as the internal slots280end at the first portion260. As the first portion260has a greater diameter than the second portion262, the second tab end208of the coupling tabs180a,180bpass freely through the first portion260to enable the removal of the needle cartridge120.

With reference toFIG.2, the retraction spring130may be a helical coil spring, which is composed of a suitable biocompatible material, such as a spring steel that is wound to form the retraction spring130. The retraction spring130is received between the second portion262of the retractor128and a surface134aof the carrier134. After deployment, the retraction spring130expands and exerts a spring force F2along the longitudinal axis L to move the retractor128toward the first inner guide surface238of the plunger122to enable the removal of the needle cartridge120.

With reference toFIG.2, the retainer132is coupled to and received about a perimeter of the carrier134. The retainer132assists in coupling or retaining the physiological characteristic sensor106on the carrier134. The retainer132may be composed of a biocompatible polymer, and may be molded, cast, printed, etc. The retainer132is the same as the sensor retainer described in U.S. application Ser. No. 16/892,854 filed on Jun. 4, 2020, previously incorporated herein by reference, and thus, the retainer132will be discussed briefly herein. Generally, the retainer132includes at least one or plurality of retainer arms282, which are spaced apart about a perimeter of the retainer132. Each of the retainer arms282is cantilevered from the retainer132, and includes a contact surface that retains the physiological characteristic sensor106in a second state. In a first state, the contact surface of the retainer arms282does not contact the physiological characteristic sensor106such that the physiological characteristic sensor106is released or uncoupled from the retainer132when the retainer arms282are in the first state. In the first state, a gap is defined between a terminal end of each of the retainer arms282and a surface of the retainer132. In the second state, each of the ribs254of the frame126contact a respective one of the retainer arms282to bias or compress the retainer arms282. In the second state, the gap is substantially eliminated and the terminal end of each of the retainer arms282contacts a surface of the retainer132. In the second state, the contact surface is held against the physiological characteristic sensor106to retain the physiological characteristic sensor106on the retainer132. Generally, the frame projections247of the plunger122contact the ribs254of the frame126, which pushes the ribs254outward, thereby releasing the retainer arms282. The release of the retainer arms282moves the retainer arms282from the second state to the first state, which releases the contact surface from the physiological characteristic sensor106.

The carrier134moves relative to the frame126to deploy the physiological characteristic sensor106onto the user. The carrier134may be composed of a biocompatible polymer, and may be molded, cast, printed, etc. The carrier134includes a support body290and a retaining flange292. The support body290is annular, and includes at least one annular projection, and in this example, includes a first annular projection294and the second annular projection256that are concentric. The first annular projection294couples the carrier134to the frame126, and the second annular projection256couples the retractor128to the carrier134. The second annular projection256may also include opposed slots296(FIG.3), which cooperate with the retractor128to couple the retractor128to the carrier134. In this example the second annular projection256extends for a distance D6from the retaining flange292. By extending the distance D6, the second annular projection256applies a force to the retaining arms266a,266bof the first portion260of the retractor128. Stated another way, the distance D6ensures that a sidewall256aof the second annular projection256applies a force to the retaining arms266a,266b, which in turn, applies a force to the needle carrier160via the lock arms178a,178bto maintain the insertion needle162in the first, extended state.

With reference toFIG.3, the carrier134also includes insertion snaps298. The insertion snaps298extend outwardly from the first annular projection294, and are received within the slots246of the frame126. Generally, the insertion snaps298are spaced apart from a surface of the slots246to inhibit a relative movement between the carrier134and the frame126. The cap138applies a force F3to the physiological characteristic sensor106in the first position, which causes the insertion snaps298of the carrier134to be spaced apart from the surface of the frame126and free floating. This ensures that if the disposable inserter104is accidentally mishandled in the first position, the carrier134is not inadvertently released.

With reference toFIG.2, a ramp surface300defined interiorly within the plunger122contacts the insertion snaps298(FIG.3) as the plunger122moves relative to the frame126. The contact between the ramp surface300and the insertion snaps298causes the insertion snaps298(FIG.3) to deflect, thereby releasing the insertion snaps298(FIG.3) from the slots246and from the frame126. The release of the carrier134from the frame126enables the insertion spring124to apply the force F1to couple the physiological characteristic sensor106to the anatomy.

With reference toFIG.3, the retaining flange292is substantially rectangular in shape, and is coupled to the retainer132. The retaining flange292includes a plurality of retaining tabs302and defines a contact surface304(FIG.2). The retaining tabs302couple the retainer132to the carrier134. With reference toFIG.2, the contact surface304is continuous and is defined about a perimeter of the retaining flange292. The contact surface304presses the adhesive patch108against the anatomy of the user upon deployment of the physiological characteristic sensor106to ensure that the adhesive patch108is coupled to the user over an entirety of the adhesive patch108.

In this example, the magnet136is coupled to the cap138. The magnet136comprises any suitable permanent magnet composed of a ferromagnetic material that is axially magnetized. As the magnet136and the cap138are the same as the magnet 214 and the cap 216 discussed in U.S. application Ser. No. 16/892,854 filed on Jun. 4, 2020, previously incorporated herein, the magnet136and the cap138will be discussed briefly herein. Generally, the magnet136is annular and cooperates with the physiological characteristic sensor106to activate the physiological characteristic sensor106based on a removal of the cap138. For example, the physiological characteristic sensor106may include a magnetic field sensor that is responsive to the magnetic field generated by the magnet136to activate the physiological characteristic sensor106based on a change in the magnetic field. The cap138may be composed of a biocompatible polymer, and may be molded, cast, printed, etc. The cap138includes a projection310, a cap base312and a sidewall314. The projection310extends axially upward from the cap base312and defines an annular channel310athat is coupled to the magnet136. The projection310terminates in a tip316. The tip316applies the force F3against the physiological characteristic sensor106, which causes the insertion snaps298(FIG.3) to float within the slots246.

The cap base312has a first base surface320opposite a second base surface322and defines a plurality of openings324. The first base surface320is coupled to or integrally formed with the projection310. The second base surface322defines a circular recess322a, which receives the membrane140. The membrane140is a gas permeable polymeric material, such as Tyvek® manufactured by DuPont™ of Midland, Mich., which is coupled to the cap138along a surface of the circular recess322a, via adhesives, heat bond, etc., for example. The openings324are covered by the membrane140. The openings324cooperate with the membrane140to enable the sterilization of the physiological characteristic sensor106contained within the disposable inserter104. Generally, the plunger122and the cap138cooperate to form a seal, such that during a sterilization procedure, the sterilization gas may penetrate into and out of the disposable inserter104, via the openings324, and sterilize the physiological characteristic sensor106and an interior of the disposable inserter104. The second end122bof the plunger122is coupled to the cap138in an interference fit, which inhibits fluids, such as air and liquids, to flow into the disposable inserter104. In this example, the sidewall314of the cap138includes a lip326, which circumscribes the cap138and receives the second end122bof the plunger122with the interference fit. The cap base312may also include a frame receiving channel328, which receives the second end126bof the frame126.

The sidewall314includes the lip326, a plurality of threads330and a frame projection332. The plurality of threads330are defined so as to be spaced apart from the lip326. The plurality of threads330engage with the threads220of the plunger122to removably couple the cap138to the plunger122. The frame projection332cooperates with a thread126cdefined on the frame126. The frame projection332acts as a thread such that the cap138is screwed onto both the frame126and the plunger122. By screwing the cap138onto both the frame126and the plunger122, the frame126is locked in position relative to the plunger122, which inhibits the frame126from moving relative to the plunger122in an instance where the disposable inserter104is mishandled or dropped.

In certain embodiments, the cap138also includes a tamper evident band or tamper band340. The tamper band340may be composed of a biocompatible polymer, and may be molded, cast, additive manufactured, etc. The tamper band340may be coupled to the cap138via a plurality of bridges, which are breakable upon unscrewing or uncoupling the cap138from the plunger122. In this example, the plunger122also defines a tamper bead retaining catch342about an outer perimeter of the plunger122. The tamper bead retaining catch342extends outward such that as the user is removing the cap138, the tamper band340contacts the tamper bead retaining catch342. The contact between the tamper band340and the tamper bead retaining catch342, along with the continued applied force by the user, separates the cap138from the tamper band340at the bridges, leaving the tamper band340about the plunger122to visually indicate the cap138has been removed.

In certain embodiments, with reference toFIG.4, in order to assemble the disposable inserter104, the needle carrier160is coupled to the insertion needle162. With the cartridge housing154formed, the third spring152is inserted into the cartridge housing154. The needle carrier160is inserted through the cartridge housing154such that the insertion needle162is in the first, extended state (FIG.7). In certain embodiments, the lock arms178a,178bmay be held during assembly by an external force to maintain the insertion needle162in the first, extended state. The cap175is coupled to the cartridge housing154. With reference toFIG.13, the needle cartridge120is inserted into the retractor128. The retaining arms266a,226bmay be held by an external force during assembly so that the retaining arms266a,266bto apply a force F4against the respective lock arms178a,178b. The application of the force F4by the retaining arms266a,266bcauses the lock arms178a,178bapply a force F5to the needle carrier160, which maintains the insertion needle162in the first, extended state.

With reference toFIG.3, with the retainer132coupled to the carrier134, the carrier134is coupled to the frame126. The retraction spring130is positioned within the second annular projection256of the carrier134. The retractor128, including the needle cartridge120, is coupled to the second annular projection256of the carrier134so that the insertion needle162remains in the first, extended state. The insertion spring124is positioned within the first annular projection294of the carrier134. With the access cover226coupled to the access opening224, the plunger122is coupled to the frame126. With reference toFIG.2, the physiological characteristic sensor106is coupled to the carrier134so as to be retained by the retainer132. The cap138, with the membrane140and the tamper band340coupled to the cap138, is threaded onto the plunger122and the frame126. The cap138is coupled to the plunger122such that the projection310applies the force F3to the physiological characteristic sensor106. The disposable inserter104is in a first position inFIG.2. The disposable inserter104, including the physiological characteristic sensor106, may be sterilized and shipped to an end user.

Once received, the user may remove the cap138. As the user unscrews the cap138, the tamper band340breaks along the bridges and remains coupled to the plunger122. With the cap138removed, the physiological characteristic sensor106is exposed for insertion. In addition, the removal of the cap138removes the magnetic field generated by the magnet136, which activates the physiological characteristic sensor106to monitor the glucose sensor114. The user may position the disposable inserter104at the desired insertion site, which may or may not be visible to the user. The user may depress the plunger122, which with reference toFIG.14, releases the carrier134and the retainer arms282of the retainer132(FIG.14). The release of the carrier134and the retainer arms282separates the physiological characteristic sensor106from the disposable inserter104. Once the carrier134is released from the frame126, the insertion spring124applies the force F1to couple the physiological characteristic sensor106to the user. As the sidewall256aof the second annular projection256of the carrier134remains adjacent to the retractor128, the retaining arms266a,266bcontinue to apply the force F4to the lock arms178a,178bof the cartridge housing154. The lock arms178a,178b, in turn, continue to apply the force F5to the needle carrier160. Stated another way, as the sidewall256aof the second annular projection256of the carrier134inhibits the outward deflection of the retaining arms266a,266b, the second retaining arm end270of the retaining arms266a,266bapplies the force F4to the second lock arm end196of the lock arms178a,178b, which in turn, applies the force F5to the chamfered surfaces170of the needle carrier160. The application of the forces F4, F5by the retractor128and the cartridge housing154of the needle cartridge120, respectively, maintain the insertion needle162in the first, extended state during the deployment of the physiological characteristic sensor106onto the anatomy. The disposable inserter104is in a second position inFIG.14.

Generally, once the insertion spring124deploys the carrier134and the physiological characteristic sensor106is coupled to the anatomy, the retraction spring130applies the force F2and retracts the retractor128upward toward the access opening224. The movement of the retractor128toward the access opening224directs or urges the needle cartridge120toward the access opening224. Once the retraction spring130has moved the retractor128past the sidewall256aof the carrier134, a force F7of the third spring152is greater than a force applied by the retaining arms266a,266band the lock arms178a,178b, as the retaining arms266a,266band the lock arms178a,178bare able to expand outwardly or deflect unrestrained by the carrier134. The force F7applied as the third spring152expands moves the needle carrier160, along with the insertion needle162, toward the cap175of the cartridge housing154, thereby moving the insertion needle162to the second, retracted state as shown inFIG.15. Stated another way, once the retractor128has moved past the sidewall256a, the retaining arms266a,266bare released, which in turn releases the lock arms178a,178b, which in turn, releases the needle carrier160such that the force F7of the third spring152may move the insertion needle162to the second, retracted state. In the second, retracted state, the insertion needle162is wholly contained within the cartridge housing154. In the second, retracted state, the second lock arm end196of the lock arms178a,178balong with the third spring152inhibit the needle carrier160from moving rearward or back into the first, extended state to thereby inhibit a potential inadvertent exposure of the insertion needle162from the cartridge housing154.

The continued application of the force F2of the retraction spring130moves the retractor128, and thus, the needle cartridge120toward the first end122aof the plunger122. When the access cover226is attached to the plunger122as shown inFIG.15, the needle cartridge120is biased by the retractor128, via the retraction spring130, toward the first end122a. Generally, as the needle cartridge120extends a distance D10(FIG.14) beyond the retractor128when assembled, the retraction spring130is not able to fully expand to position the retractor128against a surface123of the plunger122at the first end122adue to contact between the access cover226and the cap175of the cartridge156. When the access cover226is removed, by placing a finger in the recessed notch234and pulling the access cover226(FIG.15) away from the access opening224, for example, the retraction spring130is able to fully expand, and the force F2of the retraction spring130moves the retractor128toward the first end122aof the plunger122to seat the retractor128against the surface123(as shown inFIG.17). As shown inFIG.16, with the retraction spring130fully expanded, the cap175and the first cartridge end176extend beyond the surface122cof the plunger122at the first end122a, which enables the user to easily grasp and remove the needle cartridge120from the disposable inserter104(FIG.10).

With reference toFIG.17, a cross-sectional view of the needle cartridge120removed from the disposable inserter104is shown. InFIG.17, the disposable inserter104is in a third position. In the third position, the retraction spring130is fully extended such that the retractor128is coupled to the first inner guide surface238and is positioned at the surface123at the first end122a. As the needle cartridge120is removed from the disposable inserter104, the disposable inserter104may be disposed of at the user's home or other location via recycling for example. Thus, the disposable inserter104does not require the user to dispose of the disposable inserter104in a biohazard and/or sharps container as the needle cartridge120, which contains the insertion needle162, has been removed from the disposable inserter104. This provides convenience to the user, and enables the user to install the physiological characteristic sensor106and dispose of the disposable inserter104conveniently in any recycling or garbage bin. The user may also easily dispose of the needle cartridge120upon removal of the needle cartridge120from the disposable inserter104.

It should be noted that while the disposable medical device introduction system100is described herein as being used to deploy the physiological characteristic sensor assembly102, including the physiological characteristic sensor106, on the anatomy, a disposable medical device introduction system may be configured differently. In this regard, with reference toFIG.18, a disposable medical device introduction system400is shown. As the disposable medical device introduction system400includes the same or similar components as the disposable medical device introduction system100discussed with regard toFIGS.1-17, the same reference numerals will be used. In this example, the disposable medical device introduction system400includes an infusion unit assembly402and a disposable inserter404. InFIG.18, the disposable inserter404is shown in the second position, in which the disposable inserter404is coupling a portion of the infusion unit assembly402to the anatomy.

The infusion unit assembly402may comprise any suitable infusion unit associated with an infusion set for dispensing a fluid to a user for use with the disposable inserter404, and thus, the infusion unit assembly402will not be discussed in great detail herein. In this example, with reference toFIG.19, the infusion unit assembly402includes an infusion hub405, a tubing connector406and the adhesive patch108. Generally, the infusion hub405and the disposable inserter404may be packaged together for use by a consumer or user. The infusion hub405and the tubing connector406cooperate to define a fluid flow path from a fluid reservoir of a fluid infusion device, such as an insulin pump, to a body of a user.

Briefly, the infusion hub405includes an inlet410, a conduit412and a cannula414(FIG.18). The infusion hub405may also define a bore416, which enables the insertion needle162to pass through to insert the cannula414into the anatomy. The bore416may be covered by a septum. The inlet410fluidly couples the infusion hub405to the tubing connector406to define a fluid flow path between the infusion hub405and the tubing connector406. Generally, the infusion hub405is composed of a biocompatible polymer, and may be cast, printed, molded, etc. The inlet410, the conduit412and the bore416may each be integrally formed with the infusion hub405, and the cannula414may comprise a portion of flexible tubing, which is formed discretely and coupled to the infusion hub405via ultrasonic welding, for example. The infusion hub405has a hub distance D12, which is different and less than a distance D13of the tubing connector406. The inlet410is defined through a perimeter of the infusion hub405and is in fluid communication with the conduit412. The conduit412extends radially from the inlet410to the bore416. The conduit412defines a fluid flow path from the inlet410to the bore416. The bore416is defined axially though the infusion hub405. The bore416enables the insertion needle162to pass through the infusion hub405to couple the cannula414to the anatomy, and also defines a fluid flow path between the conduit412and the cannula414. The cannula414extends axially along a central axis defined by the bore416(FIG.18). The cannula defines a fluid flow path from the infusion hub405to the anatomy (FIG.18). The adhesive patch108is coupled to the infusion hub405along a bottom surface405a(FIG.18) of the infusion hub405.

With reference back toFIG.18, in various embodiments, the infusion hub405is coupled to the disposable inserter404for shipping and delivering the infusion hub405to the user. The disposable inserter404is manipulatable by a user to couple the cannula414and the infusion hub405to the user. The disposable inserter404includes the needle cartridge120, the plunger122, the insertion spring124, the frame126, the retractor128, the retraction spring130, the retainer132, the carrier134and the cap138(FIG.2). The cap138includes the membrane140(FIG.2). In this example, the disposable inserter404is the same as the disposable inserter104, however, the cap138of disposable inserter404does not include the magnet136. Thus, the disposable inserter404will not be discussed in great detail herein.

The infusion hub405is coupled to the carrier134and retained by the retainer132. The disposable inserter404, including the infusion hub405, may be sterilized and shipped to an end user. Once received, the user may remove the cap138(FIG.2). As the user unscrews the cap138, the tamper band340breaks along the bridges and remains coupled to the plunger122. With the cap138removed, the infusion hub405is exposed for insertion. The user may position the disposable inserter404at the desired insertion site, which may or may not be visible to the user. The user may depress the plunger122, which releases the carrier134and the retainer arms282of the retainer132. The release of the carrier134and the retainer arms282separates the infusion hub405from the disposable inserter404. Once the carrier134is released from the frame126, the insertion spring124applies the force F1to couple the infusion hub405to the user. The insertion needle162is maintained in the first, extended state during the deployment of the infusion hub405onto the anatomy due to the forces F4, F5applied to the needle carrier160by the lock arms178a,178band the retaining arms266a,266b, respectively.

Generally, once the insertion spring124deploys the carrier134and the infusion hub405is coupled to the anatomy, the retraction spring130applies the force F2and retracts the retractor128upward toward the access opening224. Once the retraction spring130has moved the retractor128past the sidewall256aof the carrier134, the force F7of the third spring152is greater than a force applied by the retaining arms266a,266band the lock arms178a,178b, as the retaining arms266a,266band the lock arms178a,178bare able to expand outwardly or deflect unrestrained by the carrier134. The force F7applied as the third spring152expands moves the needle carrier160, along with the insertion needle162, toward the cap175of the cartridge housing154, thereby moving the insertion needle162to the second, retracted state (FIG.15). In the second, retracted state, the insertion needle162is fully contained within the cartridge housing154.

The continued application of the force F2of the retraction spring130moves the retractor128, and thus, the needle cartridge120toward the first end122aof the plunger122. The access cover226is removed, and the retraction spring130is able to fully expand, to move the retractor128toward the first end122aof the plunger122to seat the retractor128against the surface123(as shown inFIG.17). With the retraction spring130fully expanded, the cap175and the first cartridge end176extend beyond the surface122cof the plunger122at the first end122a, which enables the user to easily grasp and remove the needle cartridge120from the disposable inserter404. With reference toFIG.20, with the infusion hub405coupled to the anatomy by the disposable inserter404, the tubing connector406may be coupled to the infusion hub405to define a fluid flow path through the tubing428to the anatomy of the user via the cannula414. Generally, the fluid flow path through the tubing428is coupled to the cannula414of the infusion hub405via the conduit412. The tubing428may be fluidly coupled to the fluid reservoir of the fluid infusion device, such as an insulin reservoir of an insulin pump.

It should be noted that while the disposable medical device introduction system100is described herein as being used to deploy the physiological characteristic sensor assembly102, including the physiological characteristic sensor106, on the anatomy, a disposable medical device introduction system may be configured differently. In this regard, with reference toFIG.21, a disposable medical device introduction system600is shown. As the disposable medical device introduction system600includes the same or similar components as the disposable medical device introduction system100discussed with regard toFIGS.1-17, the same reference numerals will be used. In this example, the disposable medical device introduction system600includes an infusion unit602and a disposable inserter604. InFIG.21, the disposable inserter604is shown in the second position, in which the disposable inserter604is coupling the infusion unit602to the anatomy.

The infusion unit602may comprise any suitable infusion unit associated with an infusion set for dispensing a fluid to a user for use with the disposable inserter604, and thus, the infusion unit602will not be discussed in great detail herein. Generally, the infusion unit602and the disposable inserter604may be packaged together for use by a consumer or user. The infusion unit602defines a fluid flow path from a fluid infusion device, such as an insulin pump, to a body of a user. In this example, with reference toFIG.22, the infusion unit602includes a hub605and the adhesive patch108.

Briefly, the hub605includes an inlet610, a conduit612and a cannula614(FIG.21). The hub605may also define a bore616, which enables the insertion needle162to pass through to insert the cannula614into the anatomy. The bore616may be covered by a septum. The inlet610fluidly couples the hub605to a tubing628to define a fluid flow path between the infusion unit602and the fluid infusion device. Generally, the hub605is composed of a biocompatible polymer, and may be cast, printed, molded, etc. The inlet610, the conduit612and the bore616may each be integrally formed with the hub605, and the cannula614may comprise a portion of flexible tubing, which is formed discretely and coupled to the hub605via ultrasonic welding, for example. In certain embodiments, the tubing628may extend through the inlet610and the conduit612and exit through the bore616to define the cannula614.

The inlet610is defined through a perimeter or circumference of the hub605and is in fluid communication with the conduit612. The inlet610is fluidly coupled to the tubing628, which is a source of fluid for the infusion unit602. Generally, the tubing628is fluidly coupled to the fluid reservoir of the fluid infusion device, such as an infusion pump, to receive a fluid, such as insulin. The conduit612extends radially from the inlet610to the bore616. The conduit612defines a fluid flow path from the inlet610to the bore616. The bore616is defined axially though the hub605. The bore616enables the insertion needle162to pass through the hub605to couple the cannula614to the anatomy, and also defines a fluid flow path between the conduit612and the cannula614. The cannula614extends axially along a central axis defined by the bore616(FIG.21). The cannula614defines a fluid flow path from the infusion unit602to the anatomy (FIG.21). The adhesive patch108is coupled to the hub605along a bottom surface605a(FIG.21) of the hub605.

With reference back toFIG.21, in various embodiments, the infusion unit602is coupled to the disposable inserter604for shipping and delivering the infusion unit602to the user. The disposable inserter604is manipulatable by a user to couple the cannula614and the infusion unit602to the user. The disposable inserter604includes the needle cartridge120, the plunger122, the insertion spring124, the frame126, the retractor128, the retraction spring130, the retainer132and the carrier134. In this example, the disposable inserter604is substantially the same as the disposable inserter104, however, the disposable inserter604does not include the magnet136or the cap138, and a portion of the plunger122, the frame126, the carrier134and the retainer132are removed to accommodate the tubing628that extends from the hub605. It should be noted that the plunger122, the frame126, the carrier134and the retainer133may be modified differently to accommodate the tubing628coupled to the infusion unit602. Generally, the plunger122, the frame126, the carrier134and the retainer133need material removed to accommodate the tubing628with a predetermined amount of clearance about the tubing628. As the components of the disposable inserter604are substantially the same as the components of the disposable inserter104except for the removal of the portion of the plunger122, the frame126, the carrier134and the retainer132to accommodate the tubing628, the disposable inserter604will not be discussed in great detail herein.

It should be noted that in certain examples, a pedestal or over covering may surround the cannula614and the insertion needle162during shipping to inhibit accidental contact with the insertion needle162and/or cannula614. Also, it should be noted that while the disposable inserter604is described herein as not including the cap138, in certain embodiments, the disposable inserter604may include a cap, similar to cap138, that presses onto the plunger122. In this example, the cap may include a projection, similar to the projection310, to support the infusion unit602during shipping to the user. The press-on cap also includes clearance for the tubing628, and may include a notch or other clearance formed about a perimeter of the cap to accommodate the tubing628.

Generally, the hub605is coupled to the carrier134and retained by the retainer132. The disposable inserter604, including the hub605, may be sterilized in suitable packaging and shipped to an end user. Once received, the user may remove the disposable inserter604from the packaging to expose the hub608for insertion. The user may position the disposable inserter604at the desired insertion site, which may or may not be visible to the user. The user may depress the plunger122, which releases the carrier134and the retainer arms282of the retainer132. The release of the carrier134and the retainer arms282separates the hub605from the disposable inserter604. Once the carrier134is released from the frame126, the insertion spring124applies the force F1to couple the hub605to the user. The insertion needle162is maintained in the first, extended state during the deployment of the hub605onto the anatomy due to the forces F4, F5applied to the needle carrier160by the lock arms178a,178band the retaining arms266a,266b, respectively.

Generally, once the insertion spring124deploys the carrier134and the hub605is coupled to the anatomy, the retraction spring130applies the force F2and retracts the retractor128upward toward the access opening224. Once the retraction spring130has moved the retractor128past the sidewall256aof the carrier134, the force F7of the third spring152is greater than a force applied by the retaining arms266a,266band the lock arms178a,178b, as the retaining arms266a,266band the lock arms178a,178bare able to expand outwardly or deflect unrestrained by the carrier134. The force F7applied as the third spring152expands moves the needle carrier160, along with the insertion needle162, toward the cap175of the cartridge housing154, thereby moving the insertion needle162to the second, retracted state (FIG.15). In the second, retracted state, the insertion needle162is fully contained within the cartridge housing154.

The continued application of the force F2of the retraction spring130moves the retractor128, and thus, the needle cartridge120toward the first end122aof the plunger122. The access cover226is removed, and the retraction spring130is able to fully expand, to move the retractor128toward the first end122aof the plunger122to seat the retractor128against the surface123(as shown inFIG.17). With the retraction spring130fully expanded, the cap175and the first cartridge end176extend beyond the surface122cof the plunger122at the first end122a, which enables the user to easily grasp and remove the needle cartridge120from the disposable inserter604. With reference toFIG.23, with the infusion unit602coupled to the anatomy by the disposable inserter604, the tubing628defines a fluid flow path to the anatomy of the user via the cannula614. The fluid flow path through the tubing628is fluidly coupled to the cannula614of the hub605via the conduit612. The tubing628may be fluidly coupled to the fluid reservoir of the fluid infusion device, such as an insulin reservoir of an insulin pump.

Thus, the disposable inserter104,404,604, which includes the needle cartridge120, enables the disposable inserter104,404,604to be recycled or otherwise disposed of easily by the user, without requiring disposal in a biohazard and/or sharps container. In this regard, the use of the needle cartridge120to contain the insertion needle162after insertion of the glucose sensor114or cannula414,614, respectively, enables the biohazard (the insertion needle162) to be removed from the disposable inserter104,404,604for separate disposal, thereby enabling recycling of the disposable inserter104,404,604. The recycling of the disposable inserter104,404,604is environmentally friendly. Moreover, the easy disposal of the disposable inserter104,404,604improves convenience for the user. In addition, the user may easily dispose of the needle cartridge120once removed from the disposable inserter104,404,604.