Infusion set with pivotable metal cannula and strain relief

Abstract

An infusion set for use with a fluid infusion device having a fluid reservoir includes an infusion cannula providing a fluid flow path and a first housing. The first housing includes a gimbal member coupled to the infusion cannula. The gimbal member is pivotable relative to the first housing to move the infusion cannula relative to the first housing. The first housing is coupled to a fluid supply line to supply fluid to the infusion cannula, and the fluid supply line will be coupled to the fluid reservoir to receive fluid. The infusion set includes a second housing, which is separated from the first housing, and the second housing surrounds the first housing and receives a portion of the fluid supply line.

Description

[0001] This application is a divisional application of the patent application for invention with the application number 201980054710.3, the application date of August 27, 2019, and the invention title of "Infusion Set with Pivoting Metal Cannula and Strain Relief".

[0002] Cross - reference to related applications

[0003] This PCT application claims the benefit and priority of U.S. Patent Application Serial No. 16 / 121,446, filed on September 4, 2018. The disclosure of the above - referenced application is incorporated herein by reference. Technical field

[0004] Embodiments of the subject matter described herein generally relate to medical devices, such as infusion sets for use with fluid infusion devices. More specifically, embodiments of the subject matter relate to an infusion unit of an infusion set for use with a fluid infusion device, having a pivoting metal cannula and an integral strain relief. Background art

[0005] According to modern medical technology, certain diseases or conditions can be treated by delivering drugs or other substances to a user's body in a continuous manner or at specific times or time intervals over a period of time. For example, diabetes is typically treated by delivering a limited amount of insulin to the user at appropriate times. Some common modes of providing insulin treatment to a user include delivering insulin through a manually operated syringe and an insulin pen. Other modern systems employ programmable fluid infusion devices (e.g., insulin pumps) to deliver a controlled amount of insulin to the user. In some cases, these fluid infusion devices require an insertion set (such as an infusion set) to be coupled to the user's body to deliver insulin. Generally, the infusion set is coupled to the fluid infusion device via a hollow tube that provides a fluid flow path from the fluid infusion device to the user. Generally, the infusion set requires, for example, a portion of the cannula to be inserted under the user's skin to deliver a controlled amount of insulin from the fluid infusion device to the user via the infusion set.

[0006] In some cases, the cannula inserted under the user's skin can be made of a polymer - based material. However, polymer - based materials are generally not rigid enough to provide a comfortable feeling to the user, and the reduced rigidity can cause the cannula to bend during use by the user. Additionally, in some cases, the cannula inserted under the user's skin can be made of a rigid material. In these cases, during the process of the user wearing the infusion set, when the hollow tube gets caught on an object, strain is directly applied to the infusion set, which may cause the metal cannula to enter the user's skin. This can make the user uncomfortable.

[0007] Accordingly, there is a desire to provide an infusion set having a pivotable metal cannula and a strain relief for coupling to a user to deliver fluid from a fluid infusion device to the user. Further, in conjunction with the accompanying drawings and the foregoing technical field and background, other desired features and characteristics will become apparent from the following detailed description and the appended claims. SUMMARY OF THE INVENTION

[0008] According to various embodiments, there is provided an infusion set for use with a fluid infusion device having a fluid reservoir. The infusion set includes a cannula providing a fluid flow path and a first housing including a gimbal member coupled to the cannula. The gimbal member is pivotable relative to the first housing to move the cannula relative to the first housing. The first housing is coupled to a fluid supply line to provide fluid to the cannula, and the fluid supply line will be coupled to the fluid reservoir to receive fluid. The infusion set includes a second housing, separate from the first housing, that surrounds the first housing and receives a portion of the fluid supply line.

[0009] According to various embodiments, there is further provided an infusion set for use with a fluid infusion device having a fluid reservoir. The infusion set includes a cannula providing a fluid flow path and a first housing including a gimbal member coupled to the cannula. The gimbal member is pivotable relative to the first housing to move the cannula relative to the first housing. The first housing is coupled to a fluid supply line to provide fluid to the cannula, and the fluid supply line will be coupled to the fluid reservoir to receive fluid. The infusion set includes a second housing, separate from the first housing, that surrounds the first housing. The second housing has a plurality of retaining flanges that cooperate to receive a portion of the fluid supply line such that the portion of the fluid supply line is positioned about the circumference of the second housing.

[0010] According to various embodiments, there is still further provided an infusion set for use with a fluid infusion device having a fluid reservoir. The infusion set includes a metal cannula providing a fluid flow path and a first housing including a gimbal member coupled to the cannula. The gimbal member is pivotable relative to the first housing to move the cannula relative to the first housing. The first housing is coupled to a fluid supply line to provide fluid to the cannula, and the fluid supply line will be coupled to the fluid reservoir to receive fluid. The infusion set includes a second housing, separate from the first housing, that surrounds the first housing. The second housing has a plurality of retaining flanges that cooperate to receive a portion of the fluid supply line such that the portion of the fluid supply line is positioned about the circumference of the second housing. The infusion set includes coupling means for removably coupling the infusion set to an anatomical structure. The coupling means includes an adhesive layer having a plurality of pedal-like portions that extend radially outward from a central portion. Both the first housing and the second housing are coupled to the coupling means.

[0011] The present invention content is provided to introduce a selection of concepts in a simplified form, and these concepts will be further described in the following detailed implementation. The present invention content is not intended to identify the key features or essential features of the claimed subject matter, nor is it intended to assist in determining the scope of the claimed subject matter. Brief Description of the Drawings

[0012] A more complete understanding of the subject matter can be obtained by referring to the detailed implementation and the claims in conjunction with the following drawings, in which like reference numerals refer to like elements in all the drawings.

[0013] Figure 1 is a perspective view of an exemplary embodiment of a fluid infusion device including an infusion kit according to various teachings of the present disclosure, the infusion kit having an infusion unit with a pivotable metal cannula and a strain relief;

[0014] Figure 2 is associated with Figure 1 a perspective view of the environment of the infusion unit and the hollow tube associated with the infusion kit of, showing the infusion unit in the installed state;

[0015] Figure 2A is associated with Figure 1 a bottom perspective view of the infusion unit and the hollow tube associated with the infusion kit of, with the coupling device removed for clarity;

[0016] Figure 3 is for Figure 1 an exploded view of a kit for the infusion kit of;

[0017] Figure 3A is Figure 2 a top perspective view of the base of the infusion unit of;

[0018] Figure 4 is Figure 2 a cross-sectional view of the infusion kit of, taken along line 4-4 of Figure 2 with the outer housing of the infusion unit, the hollow tube, and the coupling device removed for clarity;

[0019] Figure 4A is Figure 2 a bottom view of the inner housing of the infusion unit of;

[0020] Figure 4B is Figure 2 a detailed cross-sectional view of the infusion kit of, taken along line 4-4 of Figure 2 which includes the outer housing of the infusion unit and the hollow tube, but with the coupling device removed for clarity;

[0021] Figure 4C isFigure 2 Schematic cross-sectional view of an infusion set, taken along line 4-4 of Figure 2 , in which, for clarity, the outer housing, the hollow tube, and the coupling device of the infusion unit are removed, and the cannula of the infusion unit is pivoted through a positive angle;

[0022] Figure 4D is Figure 2 Schematic cross-sectional view of an infusion set, taken along line 4-4 of Figure 2 , in which, for clarity, the outer housing, the hollow tube, and the coupling device of the infusion unit are removed, and the cannula of the infusion unit is pivoted through a negative angle;

[0023] Figure 4E is Figure 1 Top perspective view of the infusion unit of , in which, for clarity, the outer housing, the inner housing, the hollow tube, and the coupling device are removed;

[0024] Figure 5 is Figure 2 Partial exploded perspective view of the coupling device of the infusion unit of , in which the mounting layer of the coupling device is partially separated from the coupling layer and the backing layer of the coupling device;

[0025] Figure 6 is at Figure 3 Detail view of the second end of the metal cannula of the infusion unit taken at 6 of ;

[0026] Figure 7 is Figure 1 Perspective view of a needle hub used with the infusion set of , in which the needle hub is coupled to the infusion set;

[0027] Figure 8 is taken along line 8-8 of Figure 7 and is a cross-sectional view of Figure 7 the needle hub and the infusion set of ;

[0028] Figure 9 is Figure 2 Perspective view of the infusion unit of , in which, for clarity, the outer housing is removed;

[0029] Figure 10 is an environmental perspective view of an exemplary infusion unit having a pivotable metal cannula and a strain relief for use with Figure 1 the infusion set of , showing the installation of the infusion unit with a removable guide pin;

[0030] Figure 11 is taken along line 11-11 of Figure 10 and is a cross-sectional view of Figure 10 the infusion unit of , in which, for clarity, the guide pin is removed;

[0031] Figure 11A is the bottom perspective view of an external housing associated with an infusion unit of Figure 10 ;

[0032] Figure 11B is Figure 10 a schematic cross-sectional view of an infusion unit of Figure 10 taken at an angle of line 11-11 of

[0033] Figure 11C wherein, for clarity, the guide pins and coupling devices are removed, and the cannula of the infusion unit pivots about positive and negative angles; Figure 11 is a detailed cross-sectional view taken at 11C of Figure 10 showing the cannula coupled to an articulating member of an infusion unit of

[0034] Figure 12 is an exploded view of a kit for an infusion set, which includes Figure 10 an infusion unit of

[0035] Figure 12A is Figure 10 the bottom perspective view of an inner housing of an infusion unit of

[0036] Figure 12B is Figure 10 the top perspective view of a base of an infusion unit of

[0037] Figure 13 is Figure 10 a partial exploded perspective view of a coupling device of an infusion unit of

[0038] Figure 14 wherein the mounting layer of the coupling device is partially disassembled from the coupling layer and the backing layer of the coupling device; Figure 10 is a perspective view of an infusion unit of

[0039] Figure 15 a cross-sectional view of an exemplary infusion unit having a pivotable metal cannula and a strain relief, for use with an Figure 1 infusion set of

[0040] Figure 16 is a schematic diagram of an exemplary embodiment of a fluid infusion device including an infusion unit according to various teachings of the present disclosure, the infusion unit having a pivotable metal cannula; and

[0041] Figure 16A is a schematic diagram of another exemplary embodiment of a fluid infusion device including an infusion unit according to various teachings of the present disclosure, the infusion unit having a pivotable metal cannula. DETAILED DESCRIPTION

[0042] The following detailed description is merely illustrative in nature and is not intended to limit the embodiments of the subject matter or the application and use of such embodiments. As used herein, the word "exemplary" means "serving as an example, instance, or illustration." Any implementation described herein as exemplary is not necessarily to be construed as preferred or advantageous over other implementations. Furthermore, it is not intended to be bound by any explicit or implicit theory present in the foregoing technical field, background technology, summary of the invention, or the following detailed description.

[0043] Certain terms may be used in the following description for reference purposes only, and thus these terms are not intended to be limiting. For example, terms such as "top", "bottom", "upper", "lower", "above", and "below" may be used to refer to directions in the accompanying drawings with reference. Terms such as "front", "rear", "back", "side", "outside", and "inside" may be used to describe the orientation and / or position of the various parts of a component in a consistent but arbitrary reference frame, which is clear by reference to the text and related drawings describing the component in question. Such terms may include the words specifically mentioned above, their derivatives, and words of similar meaning. Similarly, unless clearly indicated by the context, the terms "first", "second", and other such numerical terms referring to structures do not imply an order or sequence.

[0044] As used herein, the term "axial" refers to a direction that is generally parallel to or coincides with the axis of rotation, axis of symmetry, or centerline of one or more components. For example, in a cylinder or disk having a centerline and generally circular ends or opposing faces, the "axial" direction may refer to a direction that is generally parallel to the centerline extending between the opposing ends or faces. In some cases, the term "axial" may be used with respect to components that are not cylindrical (or otherwise radially symmetrical). For example, the "axial" direction for a rectangular housing containing a rotating shaft may be considered to be a direction that is generally parallel to or coincides with the axis of rotation of the shaft. In addition, as used herein, the term "radial" may refer to the direction or relationship of a component relative to a line extending outward in a plane of a cylinder or disk perpendicular to the centerline or axis, such as from a common centerline, axis, or similar reference. In some cases, even if one or two of the components may not be cylindrical (or otherwise radially symmetrical), the components may be considered to be "radially" aligned. In addition, the terms "axial" and "radial" (and any derivatives) may encompass directional relationships that are not precisely aligned (e.g., oblique) to the true axial and radial dimensions, provided that the relationship is primarily in the corresponding nominal axial direction or radial direction. As used herein, the term "transverse" refers to an axis that intersects another axis at an angle such that the axis and the other axis are neither substantially perpendicular nor substantially parallel.

[0045] The following description generally relates to infusion sets for treating a type of medical condition of a user. The infusion set infuses a fluid into the user's body. Non-limiting examples of the following description relate to infusion sets used in the treatment of diabetes, although embodiments of the disclosed subject matter are not limited thereto. Thus, in some embodiments, the medicament fluid being infused is insulin. However, in alternative embodiments, many other fluids may be administered by infusion, such as but not limited to disease treatment, pharmaceuticals for treating pulmonary arterial hypertension, iron chelation pharmaceuticals, pain medications, anti-cancer treatments, drugs, vitamins, hormones, etc. For the sake of brevity, conventional features and characteristics related to the operation of infusion systems, insulin pumps, and / or infusion set operation, fluid reservoirs, and fluid syringes may not be described in detail herein. Examples of infusion pumps and / or associated pump drive systems for administering insulin and other drugs may be but are not limited to the types described below: U.S. Patent Publication Nos. 2009 / 0299290 and 2008 / 0269687; U.S. Patent 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; each of which is incorporated herein by reference.

[0046] Figure 1 A perspective view of an exemplary embodiment of a fluid infusion system 100. The fluid infusion system 100 includes two main components: a fluid infusion device 102 (e.g., an insulin pump) and an infusion set 104 coupled to the fluid infusion device 102, as Figure 1Depicted in. In one example, infusion set 104 includes, but is not limited to: a hollow fluid supply line or tube 110, an infusion unit 112, and a connector assembly 114. Infusion unit 112 is coupled to a first end 116 of tube 110, and connector assembly 114 is coupled to a second end 118 of tube 110. Fluid infusion device 102 is carried or worn by a user, and infusion set 104 terminates at infusion unit 112 such that fluid infusion device 102 can deliver fluid to the user's body via tube 110. Thus, infusion unit 112 is coupled to the user's body, as described in more detail below. Fluid infusion device 102 can utilize many conventional features, components, elements, and characteristics of existing fluid infusion devices. By way of example, fluid infusion device 102 can incorporate some of the features, components, elements, and / or characteristics described in U.S. Patent Nos. 6,485,465 and 7,621,893, the relevant content of which is incorporated herein by reference. It should be noted that fluid infusion device 102 illustrated herein is merely exemplary, as any suitable fluid infusion device can be employed with infusion set 104.

[0047] Fluid infusion device 102 houses a fluid reservoir for the fluid to be delivered to the user (hidden in the Figure 1 view). Tube 110 represents the fluid flow path that couples the fluid reservoir to infusion unit 112. When installed as depicted in Figure 1 , tube 110 extends from fluid infusion device 102 to infusion unit 112, which in turn provides a fluid passage to the user's body. In some embodiments, in-line connector 110b is coupled between the ends of tube 110 to enable the user to quickly disconnect tube 110 from fluid infusion device 102. For example, in-line connector 110b can include a quick-release in-line connector, such as a connector associated with the Medtronic Paradigm TM Micro QR or Ultimate Infusion Set, which can be obtained commercially from Medtronic Minimed, Inc. of Northridge, California. For the illustrated embodiment, connector assembly 114 is implemented as a removable reservoir cap 120 (or fitting) sized and configured to accommodate replacement of the fluid reservoir (typically disposable) as needed. In this regard, reservoir cap 120 is designed to accommodate the fluid path from the fluid reservoir to tube 110.

[0048] Referring to Figure 2 , infusion unit 112 of infusion set 104 is shown installed on the skin S of the user. Infusion unit 112 receives the fluid passing through tube 110 from fluid infusion device 102 ( Figure 1)The associated fluid reservoir is delivered into the user's body. In one example, further reference is made to Figure 3 , the infusion unit 112 includes a first or outer housing 130, a second or inner housing 132, a biasing member 134 ( Figure 3 ), a gimbal member or movable needle hub 136, a base 138 ( Figure 3 ), a coupling device 140, and a needle or metal cannula 142 ( Figure 3 ). In this example, as will be discussed, the biasing member 134 ( Figure 3 ) and the movable needle hub 136 are received within a chamber defined between the inner housing 132 and the base 138. It should be noted that although the infusion unit 112 is described herein as including a biasing member 134 ( Figure 3 ), the biasing member 134 may be optional.

[0049] The outer housing 130 surrounds the inner housing 132 and the base 138. Generally, the outer housing 130 circumscribes the inner housing 132 and the base 138, but is not coupled to the inner housing 132 or the base 138. The outer housing 130 is uncoupled or separated from the inner housing 132 and the base 138 to provide strain relief to the first end 116 ( Figure 3 ) of the tube 110. In this regard, by being decoupled from the inner housing 132 and the base 138, any strain applied to the tube 110 will be dissipated by the outer housing 130, which reduces the likelihood of separation of the first end 116 of the tube 110 from the movable needle hub 136. In one example, the outer housing 130 is made of a polymer-based material, including but not limited to polypropylene, silicone, or thermoplastic elastomer. The outer housing 130 may be formed by molding, casting, printing, etc. The outer housing 130 is generally concave, however, the outer housing 130 may have any desired shape.

[0050] In this example, reference is made to Figure 3 , the outer housing 130 includes a central hole 144, an annular hub 146, and a plurality of retaining flanges 148. The central hole 144 is defined through the hub 146 of the outer housing 130 and thus extends along the axis A. The central hole 144 is sized to surround the inner housing 132 and the base 138. In one example, the central hole 144 includes a notch 150. The notch 150 is defined by the perimeter or circumference 144a of the central hole 144 and is defined to extend radially outward from the axis A. The notch 150 provides clearance for the tube when the tube 110 exits the movable needle hub 136.

[0051] The hub 146 can be coupled to the needle hub 152 to mount the infusion unit 112 on a user. In one example, the hub 146 surrounds the central bore 144 and is interconnected with each of a plurality of retaining flanges 148. The plurality of retaining flanges 148 are spaced apart around the perimeter or circumference of the hub 146. In one example, each of the plurality of retaining flanges 148 is separated by a respective one of a plurality of slots 154 defined from the outer periphery or perimeter 130a of the outer housing 130 to the hub 146. In one example, the outer housing 130 includes eight retaining flanges 148; however, the outer housing 130 can include any number of retaining flanges, such as from four to sixteen. Each retaining flange 148 includes a flange 156 and a tab 158. The flange 156 includes a pair of sidewalls 160 and a bottom 162. The pair of sidewalls 160 are coupled to the hub 146 and extend outwardly from the hub 146 at an angle toward the outer periphery 130a of the outer housing 130. The pair of sidewalls 160 interconnect the hub 146 and the bottom 162. The bottom 162 is substantially planar or flat and is coupled to the coupling device 140. Except for flange 156a, each flange 156 is substantially the same. The bottom 162a of flange 156a has an increased thickness, which enables a cutout 164 to be defined through the bottom 162a( Figure 2A ). The tab 158 extends axially from the hub 146. When the tube 110 is coupled to the movable needle seat 136, the tab 158 cooperates with the flange 156 to hold the tube 110. In this regard, due to the angle of the pair of sidewalls 160, a retaining notch 166 is defined between the bottom 162 and the tab 158. Referring to Figure 2A , the retaining notch 166 receives a portion of the tube 110 to secure the tube 110 to the outer housing 130. Generally, the plurality of retaining flanges 148 cooperate to enable the tube 110 to be positioned around the circumference of the outer housing 130 near the outer periphery 130a of the outer housing 130.

[0052] Returning to Figure 3 , the inner housing 132 holds the biasing member 134 and the movable needle seat 136 on the base 138. In one example, the inner housing 132 is formed of a polymer-based material, including but not limited to polypropylene, silicone, or thermoplastic elastomer. The inner housing 132 can be formed by molding, casting, printing, etc. The inner housing 132 is generally concave; however, the inner housing 132 can have any desired shape. The inner housing 132 includes an outer surface 170, an inner surface 172, a plurality of coupling slots 174, clearance holes 176, and a needle hole 178.

[0053] The outer surface 170 is substantially smooth and substantially conical. The inner surface 172 is opposite the outer surface 170. Referring to Figure 4, the inner surface 172 includes a biasing member clearance surface 180 and a first articulation surface 182. Refer to Figure 4A , the biasing member clearance surface 180 extends circumferentially around the inner circumference of the inner housing 132 on the inner surface 172. The biasing member clearance surface 180 provides room or clearance for the biasing member 134 to move between a compressed state and a relaxed state during use of the infusion unit 112. Generally, the biasing member clearance surface 180 has a shape corresponding to the shape of the biasing member 134 ( Figure 4 ); however, the biasing member 134 can have any desired shape.

[0054] The first articulation surface 182 is spherical and concave. The first articulation surface 182 is defined on the inner surface 172 so as to be offset from the central axis A2 of the inner housing 132. The central axis A2 is parallel to the vertical axis V ( Figure 3 ). In this example, the first articulation surface 182 is offset from the central axis A2 towards the second end 132b of the inner housing 132. Generally, the first articulation surface 182 extends from a first side 172a of the inner surface 172 to a second opposite side 172b of the inner surface 172 near or adjacent to the second end 132b of the inner housing 132. The first articulation surface 182 may include a central portion 182a having one or more ribs 182b that are spaced apart and extend radially outward from the central portion 182a. In this example, the one or more ribs 182b cooperate with the central portion 182a to define the first articulation surface 182; however, the first articulation surface 182 can be substantially uniform or continuous. Return to reference Figure 4 , the first articulation surface 182 mates with the movable needle hub 136 to enable the cannula 142 to move or pivot relative to an angle α defined between the central vertical axis V of the infusion unit 112 and an axis A3 passing through the centerline of the cannula 142. In one example, refer to Figure 4B , the angle α is from about 10 degrees to about 45 degrees. In one example, the movable needle hub 136 can move or pivot an angle β relative to the angle α. In this example, the angle β is from about ±5 degrees to about ±20 degrees relative to the angle α. Generally, the center of rotation CR of the angle β is approximately at the entry point where the cannula 142 enters the skin S ( Figure 2 ), within about ±2.5 millimeters (mm). It should be noted that the movement of the cannula 142 is conical, and the movement of the cannula 142 around the angle β is a conical movement both in and out of the plane shown in Figure 4C and 4D . As shown in Figure 4C , the deflection of the movable needle hub 136 has caused the cannula 142 to rotate a positive angle β relative to the vertical axis V. In Figure 4DIn it, the deflection of the movable needle hub 136 has caused the cannula 142 to rotate by a negative angle β relative to the vertical axis V.

[0055] Reference Figure 3 , a plurality of coupling slots 174 are spaced around the perimeter or outer periphery of the inner housing 132. In one example, the inner housing 132 includes approximately seven coupling slots 174 that cooperate with the base 138 to secure the inner housing 132 to the base 138. In this example, the size of each coupling slot 174 is determined to receive a portion of the base 138 to hold the inner housing 132 on the base 138. Return to reference Figure 4 , a clearance hole 176 is defined through the outer surface 170 and the inner surface 172 at the first end 132a of the inner housing 132. In one example, the clearance hole 176 extends from the perimeter or outer periphery of the inner housing 132 to a point P near the central axis A2 of the inner housing 132. The clearance hole 176 provides space or volume for the movable needle hub 136 and / or the tube 110 to move relative to the inner housing 132. A needle hole 178 is defined through the outer surface 170 and the inner surface 172. The needle hole 178 generally extends through the inner housing 132 and thus extends through a portion of the first articulation surface 182. Thus, in this example, the needle hole 178 is offset from the central axis A2 of the inner housing 132 and is near the second end 132b of the inner housing 132. In one example, the needle hole 178 extends along an axis that is transverse or inclined relative to the central axis A2 of the inner housing 132. The needle hole 178 receives a portion of the needle hub 152 ( Figure 3 ) to mount the infusion unit 112 on the user.

[0056] Reference Figure 3 , a biasing member 134 returns the movable needle hub 136 to a first initial or intermediate position ( Figure 4 ). In the intermediate position, the movable needle hub 136 is angled α relative to the vertical axis V. The movement or pivoting of the movable needle hub 136 compresses the biasing member 134 to provide elastic force to return the movable needle hub 136 to the intermediate position. In this example, reference Figure 3 , the biasing member 134 is a generally annular disc spring. The biasing member 134 is made of an elastomeric material, including but not limited to silicone or thermoplastic elastomer (TPE). The biasing member 134 is molded; however, the biasing member 134 can be formed by any suitable technique. The biasing member 134 includes a central member hole 186, a member clearance hole 188, and a plurality of member slots 190. In one example, the biasing member 134 includes a member hub 192 integrally formed with a member flange 194. In this example, when the inner housing 132 is coupled to the base 138, a portion of the perimeter or outer periphery of the inner housing 132 contacts the member flange 194, and the movable needle hub 136 contacts a portion of the member hub 192, as Figure 4EAs shown. The component hub 192 is generally convex, and in one example, the component hub 192 includes a relief 192a that extends around the inner perimeter of the component hub 192. In this example, a portion of the movable needle hub 136 is received within the relief 192a. Return reference Figure 3 , a central component bore 186 is defined through the component hub 192 and extends along an axis A4 that is generally parallel to the vertical axis V. The central component bore 186 is sized to receive and mate with the movable needle hub 136.

[0057] A component clearance bore 188 is defined through the component hub 192 and the component flange 194. The component clearance bore 188 provides room or space for receiving the tube 110 within the movable needle hub 136 and for moving or pivoting the movable needle hub 136 and / or the tube 110. The component clearance bore 188 is defined to align with the clearance bore of the inner housing 132. A plurality of component slots 190 are defined through the component flange 194 generally around the perimeter or outer circumference of the biasing member 134. Typically, the biasing member 134 includes approximately seven component slots 190 that are each aligned with a corresponding one of the coupling slots 174 to enable the inner housing 132 to be coupled to the base 138 ( Figure 4E ). In this example, each component slot 190 is sized such that a portion of the base 138 can pass therethrough ( Figure 4E ).

[0058] The movable needle hub 136 enables the cannula 142 to move or pivot relative to the inner housing 132 and thus the infusion unit 112. In one example, the movable needle hub 136 enables the cannula 142 to move or pivot when the user's skin S ( Figure 2 ) moves or when an external force or load is applied to the infusion unit 112. In one example, the movable needle hub 136 is constructed of a polymer-based material including, but not limited to, polypropylene, silicone, or thermoplastic elastomer. The movable needle hub 136 can be formed by molding, casting, printing, etc. Reference Figure 4 , the movable needle hub 136 includes a tube receiving portion 200, a needle guide 202, a septum 204, a septum hole 206, and a second articulation surface 208. In one example, the movable needle hub 136 is generally conical, but the movable needle hub 136 can have any desired shape.

[0059] The tube receiving portion 200 is generally cylindrical and sized to receive the first end 116 of the tube 110 and cooperate with the tube 110 to define a fluid flow path to the user. The tube receiving portion 200 is defined at the first end 136a of the movable needle hub 136. The tube receiving portion 200 includes a first end 210 and an opposite second end 212. The first end 210 receives a portion of the tube 110 adjacent to the first end 116. The second end 212 is fixedly coupled to the first end 116 of the tube 110 and includes an outlet 214. Generally, the first end 116 of the tube 110 is fixedly coupled to the second end 212 by any suitable technique, including but not limited to adhesives, ultrasonic welding, etc. The outlet 214 defines a fluid flow path from the first end 116 of the tube 110 to the cannula 142. The outlet 214 is in fluid communication with the needle guide 202 to direct fluid from the fluid reservoir of the fluid infusion device 102 into the user's body.

[0060] The needle guide 202 includes an inlet 216, a needle coupling hole 218, and an annular guide 220. The inlet 216 is in fluid communication with the outlet 214 to receive fluid. In one example, the inlet 216 is funnel-shaped to direct fluid from the outlet 214 into the cannula 142. The needle coupling hole 218 is defined between the inlet 216 and the annular guide 220. The cannula 142 is fixedly coupled to the needle coupling hole 218. In one example, the cannula 142 is fixedly coupled to the needle coupling hole 218 by adhesives, ultrasonic welding, molding, etc. The annular guide 220 extends outwardly around the needle coupling hole 218 toward the base 138. The annular guide 220 surrounds the cannula 142 and provides a stop for movement or rotation of the cannula 142. In this regard, the annular guide 220 includes a flat surface 223 extending around the periphery of the annular guide 220. A portion of the flat surface 223 contacts a portion of the base 138 to limit the range of movement of the cannula 142.

[0061] The septum 204 is coupled to the septum aperture 206. In one example, the septum 204 is fixedly attached to the septum aperture 206 by adhesives, ultrasonic welding, press fitting, etc. The septum 204 is generally circular; however, the septum 204 may have any desired shape. The septum 204 serves as a barrier to prevent fluid from entering or exiting the fluid flow path defined by the tube 110 and the cannula 142 within the infusion unit 112. The septum 204 can be pierced by the guide pin 292 of the needle hub 152 to enable the user to install the infusion unit 112. The septum aperture 206 is defined by the second articulation surface 208 and is in communication with the inlet 216. The septum aperture 206 is sized and shaped to accommodate the septum 204, and thus, in this example, the septum aperture is generally cylindrical.

[0062] The second joint surface 208 is spherical and convex. The second joint movement surface 208 is defined on the outer surface 222 of the movable needle hub 136 and is thus offset from the central axis A2 of the inner housing 132 and the vertical axis V extending through the infusion unit 112. In this example, the movable needle hub 136 is offset from the vertical axis V towards the second end 136b of the movable needle hub 136. Generally, referring to Figure 3 , the second joint movement surface 208 extends from a first side 136c of the outer surface 222 of the movable needle hub 136 to a second opposite side 136d of the outer surface 222 of the movable needle hub 136 near or adjacent to the second end 136b of the movable needle hub 136. Generally, the second joint movement surface 208 cooperates with the first joint movement surface 182 to enable the cannula 142 to move or pivot relative to the angle α at a positive or negative angle β. Generally, referring to Figure 4D , the first joint movement surface 182 and the second joint movement surface 208 are defined on the infusion unit 112 such that the center of rotation CR of the cannula 142 is located near the entry point where the cannula 142 enters the user's skin S ( Figure 2 ). The rotation of the cannula 142 about the vertical axis V of the infusion unit 112 is symmetric and conical. However, it should be understood that the rotation angle of the cannula 142 can be asymmetric if desired.

[0063] In this example, referring to Figure 4 , the movable needle hub 136 further includes a ledge 224. The ledge 224 is defined around the perimeter of the movable needle hub 136 and is sized to be received within the relief portion 192a of the member hub 192. In this example, the ledge 224 contacts and rests on the relief portion 192a of the member hub 192 such that the biasing member 134 can apply a spring force to the movable needle hub 136 to return the movable needle hub 136 to the intermediate position.

[0064] Referring to Figure 3 , the base 138 is coupled to the coupling device 140 and is coupled to the inner housing 132. The base 138 is generally circular; however, the base 138 can have any desired shape. In one example, the base 138 is made of a polymer-based material including, but not limited to, polypropylene, silicone, or thermoplastic elastomer. The base 138 can be formed by molding, casting, printing, etc. The base 138 includes a first base surface 230, a second base surface 232 opposite the first base surface 230, and a central base hole 234. The first base surface 230 includes a plurality of protrusions 240, a plurality of snap fingers 242, and a needle hub interface 244.

[0065] A plurality of protrusions 240 extend axially upward from the periphery or outer perimeter of the first base surface 230 of the base 138. In one example, the base 138 includes seven protrusions 240; however, the base 138 can have any number of protrusions 240. Each of the plurality of protrusions 240 is spaced around the perimeter of the base 138 from a first protrusion 240a to a last protrusion 240g. A gap 246 is defined between the first protrusion 240a and the last protrusion 240g to enable the tube 110 to be received within the infusion unit 112. In other words, the protrusions 240 are spaced around the perimeter of the base 138 between the first protrusion 240a and the last protrusion 240g to define the gap 246. Refer to Figure 4 , each protrusion 240 includes a first end 248 and an opposite second end 250. The first end 248 is integrally formed with the base 138, and the second end 250 is a free end. The second end 250 can include a curvature or taper 250a corresponding to the outer surface 170 of the inner housing 132 to provide an aesthetically pleasing appearance. The inner surface 241 of each protrusion 240 contacts the biasing member 134 and the inner housing 132 to assist in retaining the biasing member 134 and the inner housing 132 on the base 138.

[0066] Refer to Figure 3A , a plurality of latching fingers 242 are defined as cantilevered relative to the base 138 to enable the latching fingers 242 to move or flex to couple the inner housing 132 to the base 138. In one example, slots 252 are defined in corresponding sides of each latching finger 242 to enable the respective latching finger 242 to move relative to the base 138. Each latching finger 242 extends axially upward from the periphery or outer perimeter of the first base surface 230 of the base 138. Each latching finger 242 includes a first end 254 and an opposite second end 256. The first end 254 is integrally formed with the base 138, and the second end 256 includes a hook 258. Refer to Figure 4 , the hook 258 mates with the outer surface 170 of the inner housing 132 to connect the inner housing 132, the biasing member 134, and the movable needle hub 136 to the base 138. Thus, generally, the inner housing 132, the biasing member 134, and the movable needle hub 136 are snap-fitted to the base 138. In this example, the base 138 includes approximately six latching fingers 242; however, the base 138 can include any number of latching fingers. Additionally, in some embodiments, the base 138 does not need to include latching fingers 242 because the base 138 can be coupled to the inner housing 132 via an adhesive, ultrasonic welding, etc.

[0067] The needle hub interface 244 cooperates with the movable needle hub 136 to limit the amount of movement or rotation of the movable needle hub 136. In one example, refer to Figure 4, the needle seat interface 244 includes a first inclined surface 260 and a contoured surface 262. The first inclined surface 260 provides a stop or contact surface for the tube receiving portion 200 of the movable needle seat 136, which limits the movement or rotation of the movable needle seat 136. In one example, the first inclined surface 260 has an inclination, and its shape is designed to cooperate with the outer surface of the tube receiving portion 200. However, it should be noted that the first inclined surface 260 can have any desired shape to provide a stop for the movement of the tube receiving portion 200. The contoured surface 262 has a shape configured to match the outer surface of the inlet 216 and the annular guide 220 of the movable needle seat 136. In one example, the contoured surface 262 includes an inclined surface 262a, a flat surface 262b, and a rib 262c. Each of the inclined surface 262a, the flat surface 262b, and the rib 262c cooperate to limit the further advancement or movement of the cannula 142, for example, when the inner housing 132 is compressed by an external force. In the example of compressing the inner housing 132 by an external force, the outer surface of the annular guide 220 contacts the inclined surface 262a, and the outer surface of the inlet 216 contacts the flat surface 262b and the rib 262c.

[0068] The first base surface 230 may further include a concave relief portion 230a. During the movement or pivoting of the movable needle seat 136, the concave relief portion 230a may receive a portion of the tube 110. The second base surface 232 is substantially flat or planar. The second base surface 232 is coupled to the coupling device 140. Refer Figure 4 , a central base hole 234 is defined through the first base surface 230 and the second base surface 232. In one example, the central base hole 234 is defined through the needle seat interface 244 of the first base surface 230. A portion of the cannula 142 and the annular guide 220 extends through the central base hole 234.

[0069] Refer Figure 3, the coupling device 140 removably couples or attaches the base 138 of the infusion unit 112 to the user's body. In one example, the coupling device 140 includes an attachment layer 270, an adhesive layer 272, and a backing 274. It should be noted that the attachment layer 270 and the adhesive layer 272 are described herein as having a nominal thickness, but the attachment layer 270 and the adhesive layer 272 can have any suitable thickness required to fabricate the coupling device 140. The attachment layer 270 and the adhesive layer 272 can be formed separately or integrally. The attachment layer 270 couples or fixedly attaches the adhesive layer 272 to the second base surface 232 of the base 138. The attachment layer 270 can be coupled or attached to the second base surface 232 of the base 138 by any suitable technique including but not limited to ultrasonic welding. Generally, the attachment layer 270 couples to substantially the entire surface of the second base surface 232 of the base 138, and the surfaces 162b associated with each bottom 162 of the retention flange 148 of the outer housing 130. Thus, in one example, the attachment layer 270 is fixedly coupled to the base 138 and the outer housing 130. However, it should be noted that although the attachment layer 270 is shown herein as defining substantially the entire surface of the coupling device 140, the attachment layer 270 can be coupled to only a portion of the surface of the adhesive layer 272. For example, the attachment layer 270 can be coupled to the adhesive layer 272 so as to extend over a portion of the adhesive layer 272 corresponding to the portion of the coupling device 140 that is coupled to the base 138 and / or the outer housing 130. In other words, the size of the attachment layer 270 can be sized to correspond to the size of the base 138 and / or the outer housing 130, and can have a shape that can be different from the shape of the adhesive layer 272.

[0070] The adhesive layer 272 enables the infusion unit 112 to be removably coupled to the user's body. It should be noted that the use of the adhesive layer 272 is merely exemplary, as any suitable technique can be used to removably couple the infusion unit 112 to the user. In one example, reference Figure 5 , the adhesive layer 272 is shown in more detail. In this example, the adhesive layer 272 defines a plurality of protrusions or pedal-like portions 276 that extend radially outward from a central portion 278 of the adhesive layer 272. Generally, the adhesive layer 272 includes pedal-like portions 276 for each retention flange 148 of the outer housing 130. Thus, in this example, the adhesive layer 272 includes 8 pedal-like portions 276; however, the adhesive layer 272 can include any number of pedal-like portions.

[0071] In an example where the attachment layer 270 is shaped to correspond to the adhesive layer 272, looking back Figure 3, the mounting layer 270 further includes a plurality of pedal-shaped portions 270a. Each pedal-shaped portion 270a of the mounting layer 270 is coupled to the surface 162b of a corresponding one of the bottoms 162, while the central portion 270b of the mounting layer 270 is coupled to the base 138. Similarly, each pedal-shaped portion 276 of the adhesive layer 272 may be coupled to the user's skin S( Figure 2 ), and the central portion 278 of the adhesive layer 272 may be coupled to the user's skin S. By providing the pedal-shaped portions 270a, 276 for the mounting layer 270 and the adhesive layer 272, less strain is applied to the user's skin S( Figure 2 ). The central portion 270b of the mounting layer 270 includes a hole 270c sized such that a portion of the cannula 142 can pass therethrough. Return reference Figure 5 , the central portion 278 of the adhesive layer 272 also includes a hole 278a sized such that a portion of the cannula 142 can pass therethrough. The backing 274 is coupled to at least a portion of the adhesive layer 272 and is removable to facilitate coupling the coupling device 140 to the user, as is commonly known. It should be noted that although the mounting layer 270 and the adhesive layer 272 are separately illustrated and described herein as including the pedal-shaped portions 270a, 276, the mounting layer 270 and / or the adhesive layer 272 do not need to include the pedal-shaped portions 270a, 276. Instead, one or both of the mounting layer 270 and the adhesive layer 272 may be circular, for example Figure 13 as shown.

[0072] Return reference Figure 3, the cannula 142 delivers fluid from the tube 110 into the user's body. In this example, the cannula 142 is made of a biocompatible metal or metal alloy, including but not limited to titanium, nitinol, titanium alloy, stainless steel, etc. It should be noted that the use of the cannula 142 made of titanium, nickel-titanium alloy or titanium alloy results in a cannula 142 with increased flexibility compared to the cannula 142 made of stainless steel. Therefore, the use of titanium, nitinol or titanium alloy for the cannula 142 can provide improved comfort for the user. In one example, the cannula 142 has an outer diameter of approximately or less than 30 gauge, and in one example, the cannula 142 includes but is not limited to a 29-gauge cannula, a 29-gauge thin wall (29TW) cannula, a 29-gauge extra thin wall (29XTW), a 30-gauge, a 30-gauge thin wall (30TW) or a 30-gauge extra thin wall (30XTW). By using a thin wall or extra thin wall cannula 142 to reduce the thickness of the wall of the cannula 142, the outer diameter of the guide pin 292 can be increased relative to the outer diameter of the cannula 142, which reduces the insertion strain when the cannula 142 follows the guide pin 292 into the user's skin. The use of the thin wall or extra thin wall cannula 142 provides a larger inner diameter for the cannula 142, which can reduce blockage. The cannula 142 includes a first cannula end 280 and an opposite second cannula end 282. The cannula 142 includes a central needle bore 283 that extends from the first cannula end 280 to the second cannula end 282. The central needle bore 283 allows a portion of the needle hub 152 and fluid from the tube 110 to pass therethrough.

[0073] Reference Figure 4 , in one example, the first cannula end 280 includes a flared portion 280a. The shape of the flared portion 280a corresponds to the funnel shape of the inlet 216. The flared portion 280a of the cannula 142 and the funnel shape of the inlet 216 cooperate to guide the guide pin 292 into the cannula 142. It should be noted that the flared portion 280a of the cannula 142 can be optional, and if desired, the cannula 142 can include a cylindrical or non-flared end.

[0074] Reference Figure 6 , the second cannula end 282 is shown in more detail. In one example, the second cannula end 282 has a blunt tip 282a and includes a slot 284. By providing the blunt tip 282a on the second cannula end 282, the cannula 142 will not pierce the internal tissue under the skin when pressing the infusion unit 112 against the skin S after insertion ( Figure 2) and will not pierce the internal tissue under the skin S when the cannula 142 rotates. Thus, compared to a cannula with a sharp tip, the use of the blunt tip 282a can reduce site inflammation and discomfort. In one example, the blunt tip 282a has a bevel to minimize discomfort as the cannula 142 follows the guide pin 292 into the user's skin during insertion of the cannula 142. The slot 284 extends from the blunt tip 282a for a slot length S of the cannula 142 L . In one example, the slot length S L is from about 0.25 millimeters (mm) to about 2.0 millimeters (mm). The slot 284 has a slot width S W , which is from about 0.05 millimeters (mm) to about 0.24 millimeters (mm). The slot 284 can reduce the likelihood of blockage at the second cannula end 282 due to the compressive force applied to the blunt tip 282a. The slot 284 can be formed in the cannula 142 by laser cutting, but other machining techniques can be employed. It should be noted that although the second cannula end 282 is shown and described herein as including the slot 284, the cannula 142 does not need to include the slot 284 if desired.

[0075] Return reference Figure 3 , the user uses the needle hub 152 to install the cannula 142 into the user's body. In one example, the needle hub 152 includes a hub body 290 and a removable guide pin 292. The hub body 290 is made of a polymer-based material, including but not limited to polypropylene, polycarbonate, polyester, acrylonitrile butadiene styrene (ABS), acetal, and mixtures of these polymer-based materials. In this example, reference Figure 7 , the hub body 290 includes a hub base 294 and a grippable portion or handle 296. It should be noted that although not shown here, the handle 296 can be modified to be integrated with an insertion assist device, including but not limited to MiniMed, which are all commercially available from Medtronic Minimed of Northridge, California MiniMed etc., to assist the user in inserting the cannula 142 into the skin at an angle. The hub base 294 has a first hub side 298 and a second hub side 300. The first hub side 298 includes a recessed intermediate portion 302 and a protruding flange 304. However, it should be noted that the first hub side 298 can have any desired shape. When the needle hub 152 is coupled to the infusion unit 112, the recessed intermediate portion 302 mates with the second hub side 300 to contact a portion of the infusion unit 112. The protruding flange 304 extends around the perimeter of the recessed intermediate portion 302 and intersects the handle 296. The protruding flange 304 surrounds the perimeter of the outer housing 130 when coupled to the infusion unit 112 and helps distribute the force applied by the user to ensure that the entire adhesive layer 272 is coupled to the user's skin S.

[0076] Reference Figure 8 , shows the second hub side 300 of the hub base 294. The second hub side 300 includes a first recessed portion 306 and a second recessed portion 308. The first recessed portion 306 is opposite the protruding flange 304. When the needle hub 152 is coupled to the infusion unit 112, the first recessed portion 306 is coupled to and contacts the outer housing 130. The second recessed portion 308 is opposite the recessed intermediate portion 302. When the needle hub 152 is coupled to the infusion unit 112, the second recessed portion 308 is connected to and contacts the inner housing 132.

[0077] The handle 296 is integrally formed with the hub body 290. The handle 296 enables the user to manipulate the needle hub 152 to couple the infusion unit 112 to the user's skin S( Figure 2)。The handle 296 extends outwardly from the first base side 298. In one example, the handle 296 includes a notch 310, legs 312, and a guide hole 314. The notch 310 transitions the handle 296 from a recessed middle portion 302 to the legs 312 and defines a ledge 310a. When the needle hub 152 is coupled to the infusion unit 112, the ledge 310a is coupled to and contacts the hub 146 of the outer housing 130. The legs 312 include a surface 312a that contacts one of the bottoms 162 of one of the retaining flanges 148 to assist in coupling the infusion unit 112 to the user. The guide hole 314 extends through the handle 296 from a first handle end 296a to a second handle end 296b. The guide hole 314 removably receives the guide pin 292 within the handle 296. When the hub base 294 is coupled to the infusion unit 112, the guide hole 314 is coaxially aligned with the needle hole 178 such that the guide pin 292 passes through the needle hole 178 and the cannula 142 to insert the cannula 142 into the anatomical structure. The guide hole 314 may have different diameters corresponding to the diameter of the guide pin 292 along the guide hole 314 from the first handle end 296a to the second handle end 296b. However, it should be noted that the guide hole 314 may have any desired shape that enables the guide pin 292 to pass therethrough.

[0078] The user uses the guide pin 292 to couple the cannula 142 to the user's body. The guide pin 292 may be constructed of a biocompatible metal or metal alloy and is substantially solid or cannula-free. In one example, the guide pin 292 includes a tip 316 and an optional grippable portion 318. The tip 316 is pointed or sharp to pierce the user's skin. In one example, the tip 316 of the guide pin 292 includes, but is not limited to, a conical tip, an angled tip, or a cannula needle tip. The grippable portion 318 provides a gripping surface for the user. Although the grippable portion 318 is shown as an annular thickened portion of the guide pin 292, the grippable portion 318 may have any desired shape. In this example, the grippable portion 318 mates with a reduced diameter 314a of the guide hole 314 to prevent the tip 316 from advancing further into the user's body. In other words, the grippable portion 318 mates with the guide hole 314 to limit the advancement of the guide pin 292 into the user. It should be noted that other techniques may be employed to limit the amount of the tip 316 of the guide pin 292 that enters the user. Additionally, it should be noted that the guide pin 292 may be formed integrally with the needle hub 152, for example, by molding, and in this embodiment, the guide pin 292 may not include a grippable portion 318. In certain embodiments, reference Figure 3 , the needle hub 152, the guide pin 292, the infusion unit 112, the connector assembly 114, and the tube 110 are a kit 330 for fluidly coupling the fluid infusion device 102 ( Figure 1 ) to the user.

[0079] To assemble the infusion unit 112 and couple the tube 110 to the infusion unit 112, in one example, with the base 138 and the biasing member 134 formed, the biasing member 134 is positioned within the base 138 and retained by projections 240 generally about the perimeter of the biasing member 134. By forming the movable needle hub 136, the first end 116 of the tube 110 is fixedly coupled to the tube receiving portion 200 of the movable needle hub 136( Figure 8 ). Typically, the connector assembly 114 is coupled to the second end 118 of the tube 110 before the tube 110 is firmly coupled to the movable needle hub 136. The movable needle hub 136 with the tube 110 attached is positioned on the biasing member 134 such that the ledge 224 contacts the relief portion 192a of the biasing member 134. With the inner housing 132 formed, the inner housing 132 is snapped into the base 138 such that the movable needle hub 136 and the biasing member 134 are sandwiched between the base 138 and the inner housing 132, and a portion of the tube 110 extends through the clearance hole 176. In this regard, referring to Figure 9 , typically, each projection 240 is received within a respective one of the coupling slots 174 of the inner housing 132, and the hook 258 of each latching finger 242 engages the outer surface 170 of the inner housing 132. Returning to Figure 3 , with the outer housing 130 formed, the outer housing 130 is positioned about the inner housing 132, and a portion of the tube 110 is received within the retaining notch 166 such that this portion of the tube 110 extends generally about the circumference of the outer housing 130, adjacent to the perimeter of the outer housing 130. By forming the coupling means 140, the mounting layer 270 is fixedly coupled to the second base surface 232 and the surface 162b of each bottom 162 of the retaining flange 148. The tube 110 can be connected to the infusion unit 112 where the line connector 110b and the connector assembly 114 are connected to the tube 110 such that once the tube 110 is coupled to the assembled infusion unit 112, the infusion kit 104 is formed.

[0080] In one example, with the infusion device 104 assembled, the hub body 290 of the needle hub 152 is coupled to the infusion unit 112, and the guide pin 292 is coupled to the needle hub 152 for packaging and distribution to the user. Once received by the user, the user can remove the pre-assembled infusion kit 104 from the packaging. The user connects the infusion kit 104 to the fluid reservoir of the fluid infusion device 102, and the user activates the fluid infusion device 102 to prime the infusion kit 104. In some cases, the user can prime a portion of the tube 110 connected to the fluid infusion device 102 into the inline connector 110b, couple a portion of the tube 110 coupled to the infusion unit 112 to the remainder of the tube 110 at the inline connector 110b, and once connected, activate the fluid infusion device 102 to fill / prime the remainder of the tube 110 and the infusion unit 112.

[0081] The user can clean the insertion site on the user's skin S with alcohol. With the insertion site prepared, the user can remove the backing 274. With the backing 274 removed, the user can manipulate the hub body 290 via the handle 296 to position the infusion unit 112 on the user's skin S( Figure 2 )). In other embodiments, the user can manipulate a rapid insertion device to position the infusion unit 112 on the user's skin S. With the infusion unit 112 positioned on the user's skin S, the guide pin 292 is inserted into the guide hole 314 such that the tip 316 of the guide pin 292 extends through the cannula 142 and pierces the user's skin S to insert the second cannula end 282 of the cannula 142 into the user's body. With the cannula 142 inserted into the user's body, the infusion unit 112 is in the installed state. With the infusion unit 112 installed, the needle hub 152 is detached from the infusion unit 112, which removes the guide pin 292 from the user and leaves the infusion unit 112 coupled or installed on the user. In the installed state, the infusion unit 112 provides a fluid flow path from the fluid reservoir associated with the fluid infusion device 102( Figure 1 ) into the user's body. Once the infusion unit 112 is in the installed state, the user can smooth the adhesive layer 272 as needed.

[0082] It will be understood that the infusion unit 112 of the infusion kit 104 described Figures 1-9 can be configured differently to provide a fluid flow path from the fluid infusion device 102 to the user's body. In one example, referring to Figure 10 , an infusion unit 500 for the infusion kit 104 is shown. Since the infusion unit 500 includes the same as that described with respect to Figures 1-9The infusion units 112 being discussed have substantially similar or identical components, so the same reference numerals will be used to refer to the same or similar features.

[0083] Reference Figure 11 , shows an infusion unit 500 of an infusion set 104 mounted on the skin S of a user. The infusion unit 500 delivers fluid received via a tube 110 from a fluid reservoir associated with a fluid infusion device 102 ( Figure 1 ) into the user's body. In one example, the infusion unit 500 includes a first or outer housing 502, a second or inner housing 506, a base 508, a coupling device 510, and a needle or cannula 512.

[0084] The outer housing 502 surrounds the inner housing 506 and the base 508. Generally, the outer housing 502 circumscribes the inner housing 506 and the base 508, but is not coupled to the inner housing 506 or the base 508. The outer housing 502 is uncoupled or separated from the inner housing 506 and the base 508 to provide strain relief to the first end 116 of the tube 110. In this regard, by being decoupled from the inner housing 506 and the base 508, any strain applied to the tube 110 will be dissipated by the outer housing 502, which reduces the likelihood of separation of the first end 116 of the tube 110 from the inner housing 506. In one example, the outer housing 502 is made of a polymer-based material, including but not limited to polypropylene, silicone, or thermoplastic elastomer. The outer housing 502 can be formed by molding, casting, printing, etc. The outer housing 502 is generally concave, however, the outer housing 502 can have any desired shape.

[0085] In this example, the outer housing 502 includes a slot 518, a central hole 520, an annular hub 522, and a plurality of retaining flanges 524. The slot 518 is in communication with the central hole 520 and is elongated to enable the installation of the infusion unit 500. In one example, the slot 518 is configured to mate with a needle hub similar to the needle hub 152 to assist the user in installing the infusion unit 500. The slot 518 is defined through a first hub surface 522a of the hub 522. The central hole 520 is defined through a second hub surface 522b of the hub 522 of the outer housing 502. The size of the central hole 520 is determined to surround the inner housing 506 and the base 508. In one example, the central hole 520 includes a tapered wall 526. The tapered wall 526 is defined to be adjacent to a tapered wall 528 of the inner housing 506. The inclination or taper of the tapered wall 526 of the outer housing 502 is complementary to the inclination or taper of the tapered wall 528 of the inner housing 506 to enable the transfer of forces between the outer housing 502 and the inner housing 506, such as a compressive force applied to the outer housing 502. In one example, a gap is defined between the inner housing 506 and the outer housing 502 such that the inner housing 506 does not contact the outer housing 502 during normal use.

[0086] The hub 522 can be coupled to the needle hub to mount the infusion unit 500 on the user's body. In one example, the hub 522 surrounds the central bore 520 and interconnects each of a plurality of retaining flanges 524. The plurality of retaining flanges 524 are spaced apart around the perimeter or circumference of the hub 522. In one example, referring Figure 10 to, each of the plurality of retaining flanges 524 is separated from a corresponding one of a plurality of slots 530 defined from the outer perimeter or periphery 502a of the outer housing 502 to the hub 522. In one example, the outer housing 502 includes 8 retaining flanges 524, however, the outer housing 502 can include any number of retaining flanges, such as 4 to 16. Referring Figure 11 and 11A , each retaining flange 524 includes a retaining notch 536. The retaining notch 536 is generally U-shaped and is defined through each retaining flange 524 from a first flange surface 538 toward a second flange surface 540 ( Figure 11 ). The size and shape of each retaining notch 536 are configured to receive a portion of the tube 110 to secure the tube 110 to the outer housing 130. Generally, the retaining notches 536 of the retaining flanges 524 cooperate to enable the tube 110 to be positioned around the circumference of the outer housing 502 near the outer perimeter 502a of the outer housing 130 ( Figure 10 ). Except for the retaining flange 524a, each retaining flange 524 is substantially the same. The retaining flange 524a includes a cutout 542 defined through the first flange surface 538 that is in communication with the retaining notch 536. The cutout 542 enables a portion of the tube 110 to pass through the retaining flange 524a.

[0087] As will be discussed, referring Figure 11 to, the articulating member enables the cannula 512 to move or pivot relative to the inner housing 506 and thus relative to the outer housing 502 and the infusion unit 500. In one example, when the user's skin S moves or when an external force or load is applied to the infusion unit 500, the articulating member is received within the inner housing 506 enabling the cannula 512 to move or pivot. In one example, the inner housing 506 is composed of a polymer-based material including but not limited to polypropylene, silicone, or thermoplastic elastomer. The inner housing 506 can be formed by molding, casting, printing, etc. Referring Figure 12 , the inner housing 506 is generally annular, however, the inner housing 506 can have any desired shape. In one example, returning to refer Figure 11, the inner housing 506 includes a tube receiving portion 550, a needle guide 552, a septum 554, a septum aperture 556, a seal 558, and a gimbal member 560. In one example, the inner housing 506 is generally circular, but the inner housing 506 can have any desired shape.

[0088] The tube receiving portion 550 is generally cylindrical and sized to receive the first end 116 of the tube 110 and cooperate with the tube 110 to define a fluid flow path to the user. The tube receiving portion 550 is defined at the first needle seat end 506a of the inner housing 506. The tube receiving portion 550 includes a first end 562 and an opposite second end 564. The first end 562 receives a portion of the tube 110 adjacent to the first end 116. The diameter of the first end 562 can be greater than the diameter of the second end 564. In this example, the first end 562 flares outwardly toward the first needle seat end 506a of the inner housing 506. The outward flaring of the first end 562 defines a socket that can receive an adhesive or other coupling mechanism for securing the tube 110 to the tube receiving portion 550. The second end 564 is fixedly coupled to the first end 116 of the tube 110 and includes an outlet 566. Generally, the first end 116 of the tube 110 is fixedly coupled to the second end 564 by any suitable technique, including but not limited to adhesives, ultrasonic welding, etc. The outlet 566 defines a fluid flow path from the first end 116 of the tube 110 to the cannula 512. The outlet 566 is in fluid communication with the needle guide 552 to direct fluid from the fluid reservoir of the fluid infusion device 102 ( Figure 1 ) to the user's body.

[0089] The needle guide 552 includes an inlet 570, a gimbal member aperture 572, and a seal aperture 574. The inlet 570 is in fluid communication with the outlet 566 to receive fluid. In one example, the inlet 570 is generally funnel-shaped to direct fluid from the outlet 566 into the cannula 512. The gimbal member aperture 572 is adjacent to or proximate the inlet 570 and is in communication with the inlet 570 and the seal aperture 574. The gimbal member aperture 572 is generally spherical and sized to receive the gimbal member 560. For example, based on the movement of the cannula 512, the gimbal member aperture 572 enables the gimbal member 560 to move within the gimbal member aperture 572. The seal aperture 574 surrounds a portion of the gimbal member aperture 572. The seal aperture 574 is generally cylindrical and sized to receive the seal 558. Generally, the seal 558 is fixedly attached to the seal aperture 574 by an adhesive, ultrasonic welding, etc.

[0090] The septum 554 is coupled to the septum aperture 556. In one example, the septum 554 is fixedly coupled to the septum aperture 556 by an adhesive, ultrasonic welding, press fit, etc. Refer to Figure 12, the septum 554 is generally spherical; however, the septum 554 can have any desired shape. The septum 554 serves as a barrier to prevent fluid from flowing in and out of the fluid flow path defined by the tube 110 and the cannula 512 within the infusion unit 500. The septum 554 can be pierced by the guide pin 292 to enable the user to install the infusion unit 500. Return reference Figure 11 , the septum hole 556 is defined through the first needle seat surface 506b and communicates with the inlet 570. The size and shape of the septum hole 556 are designed to accommodate the septum 554. In one example, the septum hole 556 is generally cylindrical, and the diameter of the septum 554 is greater than the diameter of the septum hole 556 to form a seal between the septum 554 and the septum hole 556.

[0091] The seal 558 prevents fluid from flowing out of the inlet 570. In one example, reference Figure 12 , the seal 558 is substantially annular. The outer periphery 558a of the seal 558 is fixedly coupled to the seal hole 574 via an adhesive, ultrasonic welding, etc. The seal 558 is generally made of a material based on a biocompatible polymer, including but not limited to elastomers, silicones, etc. In one example, the seal 558 includes a central seal hole 580. The central seal hole 580 is cylindrical and sized to surround a portion of the articulating member 560, as Figure 11 shown. The central seal hole 580 enables the articulating member 560 to move while prohibiting fluid from flowing out of the inner housing 506.

[0092] The articulating member 560 is received between the inner housing 506 and the base 508. The articulating member 560 is movable relative to the inner housing 506 and the base 508 to enable the cannula 512 to move relative to the infusion unit 500. The articulating member 560 is offset from the central vertical axis V defined by the infusion unit 500. In this example, the cannula 512 is fixedly coupled to the articulating member 560. In one example, the cannula 512 is fixedly coupled to the articulating member 560 by an adhesive, ultrasonic welding, overmolding, press fit, etc. Generally, reference Figure 11C , the first cannula end 514 is coupled to the articulating member 560 so as to coincide with the outer surface 560a of the articulating member 560. Alternatively, the first cannula end 514 can be recessed within the articulating member 560. As a further alternative, the first cannula end 514 can be flared, similar to Figures 1-9The first cannula end 280 of the cannula 142. The articulating member 560 is spherical and made of a polymer-based material, including but not limited to polypropylene, polycarbonate, polyester, acrylonitrile butadiene styrene (ABS), acetal, polyetheretherketone (PEEK). The articulating member 560 can be formed by molding, printing, casting, etc. Additionally, the articulating member 560 can be formed by overmolding the articulating member 560 onto the cannula 512.

[0093] Reference Figure 11 , the articulating member 560 moves or pivots along the cooperating spherical surface of the articulating member bore 572. Generally, the articulating member 560 cooperates with the inner housing 506 to enable the cannula 512 to move or pivot relative to an angle α defined between the vertical axis V of the infusion unit 500 and an axis A3 passing through the centerline of the cannula 512. In one example, the angle α is from about 10 degrees to about 45 degrees. In one example, the articulating member 560 can move or pivot an angle β relative to the angle α. In this example, the angle β is from about ±5 degrees to about ±20 degrees relative to the angle α. Generally, the articulating member 560 is coupled to the infusion unit 500 such that the center of rotation CR1 of the cannula 512 is located near the entry point where the cannula 512 enters the user's skin S, within about ±2.5 millimeters (mm). Generally, in one example, the center of rotation CR1 is above the user's skin S but within about ±2.5 millimeters (mm). It should be noted that the movement of the cannula 512 is conical, and thus the movement of the cannula 512 about the angle β is a conical movement both in and out of the Figure 11B plane shown. In this example, the rotation of the cannula 512 about the vertical axis V of the infusion unit 500 is symmetric and conical. However, it should be understood that if desired, the rotation angle of the cannula 512 can be asymmetric. As Figure 11B shown, movement of the inner housing 506 in the direction DR can cause the cannula 512 to rotate a negative angle β relative to the vertical axis V of the infusion unit 500. Similarly, movement of the inner housing 506 in the direction opposite to the direction DR can cause the cannula 512 to rotate a positive angle β relative to the vertical axis V of the infusion unit 500.

[0094] In one example, the bore 590 of the base 508 can define the range of movement of the cannula 512. In this example, the sidewall 590a of the bore 590 can contact the cannula 512 to stop further movement of the cannula 512 and thus stop further movement of the articulating member 560 relative to the inner housing 506 and the base 508. In one example, the sidewall 590a can include an inclined portion on one side. However, it should be noted that the sidewall 590a can include an inclined portion around the entire sidewall 590a, or the sidewall 590a can be substantially straight.

[0095] The inner housing 506 is fixedly coupled to the base 508. In one example, the inner housing 506 includes a plurality of mounting coupling features or grooves 592 that extend around a portion of the circumference of the inner housing 506. In this example, referring Figure 12A to, the inner housing 506 includes two grooves 592 that are spaced apart to define a dispensing channel for dispensing an adhesive to couple the inner housing 506 to the base 508. However, it should be noted that in other embodiments, the grooves 592 can be used to define ultrasonic welding. Generally, referring Figure 12 to, each groove 592 is defined from a second pin seat surface 506c toward a first pin seat surface 506b. The first pin seat surface 506b is opposite the second pin seat surface 506c, and the first pin seat end 506a is opposite the second pin seat end 506d. The first pin seat surface 506b may also include a plurality of substantially triangular reliefs 594 spaced around the circumference of the inner housing 506. The reliefs 594 assist in forming the inner housing 506.

[0096] The base 508 is coupled to the coupling device 510 and is coupled to the inner housing 506. The base 508 is generally circular; however, the base 508 can have any desired shape. In one example, the base 508 is made of a polymer-based material, including but not limited to polypropylene, silicone, or thermoplastic elastomer. The base 508 can be formed by molding, casting, printing, etc. The base 508 includes a first base surface 600, a second base surface 602 opposite the first base surface 600, and a hole 590.

[0097] Referring Figure 12B to, the first base surface 600 includes a plurality of ribs 604, a seal interface 606, and a tube receiving interface 608. The plurality of ribs 604 axially extend upward from the first base surface 600 near the perimeter or outer circumference 600a of the first base surface 600. In one example, the base 508 includes two circular ribs 604 that extend around a portion of the first base surface 600 and each is intersected by a tube receiving interface 608. Each circular rib 604 is received in a corresponding one of the grooves 592 of the inner housing 506 to couple the inner housing 506 to the base 508. In one example, the ribs 604 are coupled to the grooves 592 by an adhesive; however, the ribs 604 can be coupled to the grooves 592 by ultrasonic welding, snap fit, etc.

[0098] The seal interface 606 cooperates with the inner housing 506 to hold the seal 558. In one example, the seal interface 606 is a surface defined radially inward from the rib 604. The seal interface 606 also generally circumscribes the aperture 590. In one example, a recessed groove 590b is defined around the aperture 590 proximate the seal interface 606 to provide an articulation surface for the articulation member 560. The tube receiving interface 608 has a shape corresponding to the outer surface of the tube receiving portion 550 of the base 508. In one example, the tube receiving interface 608 is substantially curved and includes a concave relief 608a. The concave relief 608a receives a portion of the outer surface of the tube receiving portion 550 of the inner housing 506 to assist in coupling the inner housing 506 to the base 508.

[0099] The second base surface 602 is substantially flat or planar. Referring Figure 11 , the second base surface 602 is coupled to the coupling device 510. The aperture 590 is defined through the first base surface 600 and the second base surface 602. The aperture 590 is defined through the base 508 such that it extends generally along an axis A3 that is transverse or inclined to the vertical axis V. The cannula 512 extends through the aperture 590.

[0100] Referring Figure 11 , the coupling device 510 removably couples or secures the base 508 of the infusion unit 500 to the user's body. In one example, referring Figure 13, in one example, the coupling device 510 includes a mounting layer 610, an adhesive layer 612, and a backing 274. It should be noted that the mounting layer 610 and the adhesive layer 612 are described herein as having a nominal thickness, but the mounting layer 610 and the adhesive layer 612 can have any suitable thickness required to fabricate the coupling device 510. The mounting layer 610 and the adhesive layer 612 can be formed separately or integrally. The mounting layer 610 couples or fixedly attaches the adhesive layer 612 to the second base surface 602 of the base 508 and the surface 524b of each retaining flange 524. The mounting layer 610 can be coupled or fixed to the second base surface 602 of the base 508 and the surface 524b of the retaining flange 524 by any suitable technique including but not limited to ultrasonic welding. Generally, the mounting layer 610 couples to substantially the entire surface of the second base surface 602 of the base 508 and the surface 524b associated with the retaining flange 524 of the outer housing 502. Thus, in one example, the mounting layer 610 is fixedly coupled to the base 508 and the outer housing 502. However, it should be noted that although the mounting layer 610 is shown herein as defining substantially the entire surface of the coupling device 510, the mounting layer 610 can be coupled to only a portion of the surface of the adhesive layer 612. For example, the mounting layer 610 can be coupled to the adhesive layer 612 so as to extend over a portion of the adhesive layer 612 corresponding to the portion of the coupling device 510 that is coupled to the base 508 and / or the outer housing 502. In other words, the size of the mounting layer 610 can be sized to correspond to the size of the base 508 and / or the outer housing 502 and can have a shape that can be different from the shape of the adhesive layer 612.

[0101] The adhesive layer 612 enables the infusion unit 500 to be removably coupled to the user's body. It should be noted that the use of the adhesive layer 612 is merely exemplary, as any suitable technique can be used to removably couple the infusion unit 500 to the user. In one example, the adhesive layer 612 is shown in more detail. In this example, the adhesive layer 612 is annular; however, the adhesive layer 612 can include a plurality of pedal-like portions, such as the plurality of pedal-like portions 276. Since the mounting layer 610 is shaped to correspond to the adhesive layer 612, in this example, the mounting layer 610 is also annular. The mounting layer 610 includes a hole 610a sized such that a portion of the cannula 512 can pass therethrough. The adhesive layer 612 also includes a hole 612a sized such that a portion of the cannula 512 can pass therethrough. The backing 274 is coupled to at least a portion of the adhesive layer 612 and is removable to facilitate coupling the coupling device 140 to the user, as is commonly known.

[0102] Reference Figure 11C, the cannula 512 delivers fluid from the tube 110 into the user's body. In this example, the cannula 512 is constructed of a biocompatible metal or metal alloy, including but not limited to titanium, nitinol, titanium alloy, stainless steel, etc. It should be noted that the use of the cannula 512 made of titanium, nickel-titanium alloy or titanium alloy results in a cannula 512 with increased flexibility compared to the cannula 512 made of stainless steel. Therefore, the use of titanium, nitinol or titanium alloy for the cannula 512 can provide improved comfort for the user. In one example, the cannula 512 has an outer diameter of approximately or less than 30 gauge, and in one example, the cannula 512 includes but is not limited to a 29-gauge cannula, a 29-gauge thin-wall (29TW) cannula, a 29-gauge extra-thin-wall (29XTW), 30-gauge, 30-gauge thin-wall (30TW) or 30-gauge extra-thin-wall (30XTW). By using a thin-wall or extra-thin-wall cannula 512 to reduce the thickness of the wall of the cannula 512, the outer diameter of the guide pin 292 can be increased relative to the outer diameter of the cannula 512, which makes the insertion less invasive when the cannula 512 follows the guide pin 292 into the user's skin. The use of the thin-wall or extra-thin-wall cannula 512 allows for a larger inner diameter to be provided for the cannula 512, which can reduce blockages. The cannula 512 includes a first cannula end 514 and an opposite second cannula end 282. The cannula 512 includes a central needle bore 283 that extends from the first cannula end 514 to the second cannula end 282. In one example, the first cannula end 514 is substantially cylindrical.

[0103] The guide pin 292 is used to insert the cannula 512 into the user's body. In one example, the tip 316 of the guide pin 292 pierces the user's skin S( Figure 11 ) to insert the cannula 512 into the user's body. The grippable portion 318 can provide a gripping surface for the user to manipulate the guide pin 292. It should be noted that although not shown here, the grippable portion 318 can be modified to be integrated with an insertion assist device, which includes but is not limited to MiniMed MiniMed etc., which are all commercially available from Medtronic Minimed, Northridge, California, to assist the user in inserting the cannula 142 at an angle into the skin. In certain embodiments, referring to Figure 12 , the guide pin 292, the infusion unit 500, the connector assembly 114 and the tube 110 are a kit 650 for fluidly coupling the fluid infusion device 102( Figure 1 ) to the user.

[0104] To assemble the infusion unit 500, in one instance, with the base 508 and the seal 558 formed, the seal 558 is positioned within the base 508 on the seal interface 606. With the inner housing 506 formed, the first end 116 of the tube 110 is fixedly coupled to the tube receiving portion 550 of the inner housing 506( Figure 11 ). Typically, the connector assembly 114 is coupled to the second end 118 of the tube 110 before the tube 110 is rigidly coupled to the inner housing 506. With the articulation member 560 and the cannula 512 formed, the cannula 512 is fixedly coupled to the articulation member 560 such that it extends through the articulation member 560. The articulation member 560 is coupled to the central seal bore 580 of the seal 558 such that the cannula 512 extends through the bore 590 of the base 508. The septum 554 is inserted into the septum bore 556 of the inner housing 506 and the inner housing 506, with the tube 110 attached, is coupled to the base 508 such that the ribs 604 snap fit into a corresponding one of the grooves 592( Figure 11 ).

[0105] Reference Figure 14 , the tube 110 can be positioned around the outer perimeters of the inner housing 506 and the base 508. With the outer housing 502 formed, the outer housing 502 is positioned around the inner housing 506 and a portion of the tube 110 is received within the retention notch 536 such that this portion of the tube 110 extends substantially circumferentially around the outer housing 502, adjacent to the perimeter 502a of the outer housing 502, as Figure 11 shown. By forming the coupling means 510, the mounting layer 610 is fixedly coupled to each of the second base surface 602 and the surface 524b of the retention flange 524. The tube 110 can be connected to the infusion unit 500 where the line connectors 110b and the connector assembly 114 are connected to the tube 110 such that once the tube 110 is coupled to the assembled infusion unit 112, an infusion kit 104 is formed.

[0106] In one example, with the infusion device 104 assembled, the needle hub is coupled to the infusion unit 500, and the guide pin 292 is coupled to the needle hub for packaging and distribution to the user. Once received by the user, the user may remove the pre-assembled infusion kit 104 from the packaging. The user connects the infusion kit 104 to the fluid reservoir of the fluid infusion device 102, and the user activates the fluid infusion device 102 to prime the infusion kit 104. In some cases, the user may prime a portion of the tube 110 that is connected to the fluid infusion device 102 into the in-line connector 110b, couple a portion of the tube 110 that is coupled to the infusion unit 500 to the remainder of the tube 110 at the in-line connector 110b, and once connected, activate the fluid infusion device 102 to fill / prime the remainder of the tube 110 and the infusion unit 500.

[0107] The user may clean the insertion site on the user's skin S with alcohol. With the insertion site prepared, the user may remove the backing 274. With the backing 274 removed, the user may operate the outer housing 502 via the needle hub that is coupled to the outer housing 502, such as to position the infusion unit 500 on the user's skin S( Figure 2 )). In other embodiments, the user may manipulate a rapid insertion device to position the infusion unit 500 on the user's skin S. With the infusion unit 500 positioned on the user's skin S, the guide pin 292 is inserted into the septum aperture 556 such that the tip 316 of the guide pin 292 extends through the cannula 512 and pierces the user's skin S to insert the second cannula end 282 of the cannula 512 into the user's body. With the cannula 512 inserted into the user's body, the infusion unit 500 is in the installed state. With the infusion unit 500 installed, the needle hub is disengaged from the infusion unit 500, which disengages the guide pin 292 from the infusion unit 500 while maintaining the infusion unit 500 in connection with the user. In the installed state, the infusion unit 500 provides a fluid flow path from the fluid reservoir associated with the fluid infusion device 102( Figure 1 ) into the user's body.

[0108] Accordingly, the infusion units 112, 500 provide improved comfort to the user by providing a pivotable metal cannula with an integral strain relief. In this regard, the use of metal cannulas 142, 512 with a blunt second cannula end 282 can reduce tissue inflammation because the metal cannulas 142, 512 do not pierce tissue when the infusion units 112, 500 are subject to an external force or load and do not pierce tissue when the metal cannulas 142, 512 are moved or pivoted. Additionally, the use of titanium, nitinol, or a titanium alloy for the metal cannulas 142, 512 imparts flexibility to the metal cannulas 142, 512 while maintaining the metal cannulas 142, 512' resistance to bending and kinking, which reduces tissue damage and inflammation and can result in a longer service life. The outer housings 130, 502 also distribute the external force and load over a larger area, such as a compressive load and a shear shock, which reduces the discomfort of the user. Further, by decoupling from the movable needle hub 136 or the inner housing 506, the respective outer housings 130, 502 reduce the likelihood of the tube 110 separating from the movable needle hub 136 or the inner housing 506, and improve the comfort of the user because any pulling on the tube 110 results in a pull on the respective outer housing 130, 502 rather than on the respective movable needle hub 136 or inner housing 506. Additionally, since any strain applied to the tube 110 is distributed by the respective outer housing 130, 502, the decoupled outer housing 130, 502 reduces the need for another adhesive layer for securing the respective inner housing 132 or inner housing 506. The use of the coupling device 140 with the adhesive layer 272 having the pedal-like portions 276 also improves user comfort by reducing the circumferential strain on the curved portion of the user's body. Additionally, the pedal-like portions 276 reduce the likelihood of the adhesive layer 272 peeling away from the user's body because the peeling of one of the pedal-like portions 276 may not result in the peeling of the central portion 278 of the adhesive layer 272 because the peeling of one of the pedal-like portions 276 may not propagate through the central portion 278. Accordingly, the adhesive layer 272 of the coupling device 140 reduces the likelihood of the infusion unit 112 accidentally disengaging from the user.

[0109] In addition, it should be noted that although the outer housings 130, 502 are described and shown herein as generally conical structures surrounding the inner housings 132 and 506, respectively, it should be understood that the outer housings 130, 502 can be configured in a variety of different ways to provide strain relief to the infusion units 112, 500. In one example, the outer housing can include a plurality of individual, separate, or segmented "pie-shaped" pieces that are positioned around the respective one of the inner housings 132 and 506. Each segmented pie-shaped piece will be separated from the other segmented pie-shaped pieces and the respective one of the inner housings 132 and 506, thereby enhancing the overall site flexibility and comfort. In other examples, instead of the outer housing, a thin adhesive patch spoke-like structure can be formed and used to adhere the tube 110 at a plurality of locations around the perimeters of the inner housings 132 and 506, which will be used to protect the inner housings 132 and 506 from strain or impact.

[0110] It will be understood that the infusion unit 112 of the infusion set 104 described Figures 1-9 can be configured differently to provide a fluid flow path from the fluid infusion device 102 to the user's body. In one example, referring Figure 15 to, a cross-section of another exemplary infusion unit 700 for the infusion set 104 is shown. Since the infusion unit 700 includes components that are substantially similar or identical to those of the infusion unit 112 discussed Figures 1-9 , the same reference numerals will be used to refer to the same or similar features. The infusion unit 700 delivers the fluid received through the tube 110 from a fluid reservoir associated with the fluid infusion device 102 ( Figure 1 ) to the user's body. In one example, the infusion unit 700 includes a first or outer housing 130, a second or inner housing 702, a biasing member 134, a gimbal member or movable needle hub 704, a base 706, a coupling device 140, and a needle or metal cannula 142 ( Figure 3 ). In this example, the biasing member 134 and the movable needle hub 704 are housed within a chamber defined between the inner housing 702 and the base 706. It should be noted that although the infusion unit 700 is described herein as including a biasing member 134, the biasing member 134 can be optional.

[0111] The outer housing 130 surrounds the inner housing 702 and the base 706, but is not coupled to the inner housing 702 or the base 706. The inner housing 702 holds the biasing member 134 and the movable needle hub 704 on the base 706. In one example, the inner housing 702 is made of a polymer-based material, including but not limited to polypropylene, silicone, or thermoplastic elastomer. The inner housing 702 can be formed by molding, casting, printing, etc. The inner housing 702 is generally concave, however, the inner housing 702 can have any desired shape. The inner housing 702 includes an outer surface 710, an inner surface 712, a plurality of coupling grooves 174, a tube receiving portion 716, and a needle aperture 178.

[0112] The outer surface 710 is substantially smooth and substantially conical. The inner surface 712 is opposite the outer surface 710. The inner surface 712 includes a biasing member clearance surface 180 and a first articulation surface 182. The first articulation surface 182 is spherical and concave. The first articulation surface 182 is defined on the inner surface 712 so as to be offset from the central axis of the inner housing 702. In this example, the first articulation surface 182 is offset from the central axis towards the second end 702b of the inner housing 702. Generally, the first articulation surface 182 extends from a first side of the inner surface 712 to a second opposite side of the inner surface 712 near or adjacent to the second end 702b of the inner housing 702. The first articulation surface 182 cooperates with the movable needle hub 704 to enable the cannula 142 to move or pivot relative to an angle α defined between the central vertical axis V of the infusion unit 700 and an axis A3 passing through the centerline of the cannula 142. In one example, the movable needle hub 704 can move or pivot at an angle β relative to the angle α.

[0113] The tube receiving portion 716 is generally cylindrical and sized to receive the first end 116 of the tube 110 and cooperate with the tube 110 to define a fluid flow path to the user. The tube receiving portion 716 is defined at the first end 702a of the inner housing 702. The tube receiving portion 716 includes a first end 720 and an opposite second end 722. The first end 720 receives a portion of the tube 110 adjacent to the first end 116. The second end 722 is fixedly coupled to the first end 116 of the tube 110 and includes an outlet 724. Generally, the first end 116 of the tube 110 is fixedly coupled to the second end 722 by any suitable technique, including but not limited to adhesives, ultrasonic welding, etc. The outlet 724 defines a fluid flow path from the first end 116 of the tube 110 to the movable needle hub 704. The outlet 724 is in fluid communication with the movable needle hub 704 to direct fluid from the fluid reservoir of the fluid infusion device 102 into the user's body.

[0114] The movable needle hub 704 enables the cannula 142 to move or pivot relative to the inner housing 702 and thus the infusion unit 700. In one example, the movable needle hub 704 enables the cannula 142 to move or pivot when the skin S of the user ( Figure 2 ) moves or when an external force or load is applied to the infusion unit 700. In one example, the movable needle hub 704 is made of a polymer-based material, including but not limited to polypropylene, silicone, or thermoplastic elastomer. The movable needle hub 704 can be formed by molding, casting, printing, etc. In one example, the movable needle hub 704 includes a needle guide 202, a septum 204, a septum aperture 206, a second articulation surface 208, a ledge 224, a fluid conduit 730, and at least one seal member 732. In one example, the movable needle hub 704 is generally conical, but the movable needle hub 704 can have any desired shape.

[0115] The fluid conduit 730 fluidly couples the movable needle hub 704 to the inner housing 702. In one example, the fluid conduit 730 is defined as extending from a first end 704a of the movable needle hub 704 through the movable needle hub 704 to an inlet 216 of the needle guide 202. The fluid conduit 730 is cylindrical; however, the fluid conduit 730 can have any desired shape. The fluid conduit 730 includes a conduit inlet 730a at the first end 704a and a conduit outlet 730b. The conduit inlet 730a is fluidly coupled to an outlet 724 of the inner housing 702, and the conduit outlet 730b is fluidly coupled to the inlet 216 of the needle guide 202 such that fluid can flow from a first end 116 of the tube 110 through the inner housing 702, the movable needle hub 704, and into the cannula 142.

[0116] At least one sealing member 732 substantially surrounds the catheter inlet 730a. In one embodiment, the at least one seal 732 is a single seal; however, multiple sealing members may be used. In this example, the sealing member 732 ensures that fluid from the tube 110 enters the fluid conduit 730. The sealing member 732 is generally annular. The sealing member 732 is held between the inner housing 702 and the movable needle hub 704. In one example, the sealing member 732 may be fixedly coupled to the inner surface 712 of the inner housing 702 via an adhesive, ultrasonic welding, etc. In this example, the inner surface 712 may define an annular notch 712a that may at least partially receive the sealing member 732, and the sealing member 732 may be fixedly coupled to the annular notch 712a. The sealing member 732 is typically composed of a biocompatible polymer-based material, including but not limited to elastomers, silicones, etc. In one example, the sealing member 732 includes a central member hole 734. The central member hole 734 is circular and sized to surround the catheter inlet 730a. The sealing member 732 enables the movable needle hub 704 to move while inhibiting fluid outflow.

[0117] The base 706 is coupled to the coupling device 140 and coupled to the inner housing 702. The base 706 is generally circular; however, the base 706 may have any desired shape. In one example, the base 706 is composed of a polymer-based material, including but not limited to polypropylene, silicone, or thermoplastic elastomer. The base 706 may be formed by molding, casting, printing, etc. The base 706 includes a first base surface 740, a second base surface 232 opposite the first base surface 230, and a central base hole 234. The first base surface 740 includes a plurality of protrusions 240, a plurality of snap fingers 242, and a needle hub interface 742. It should be noted that in alternative embodiments, the first base surface 740 may include other features that enable the base 706 to be coupled to the inner housing 702 via, for example, ultrasonic welding or an adhesive rather than via the snap fit of the plurality of snap fingers 242.

[0118] The needle seat interface 742 cooperates with the movable needle seat 704 to limit the amount of movement or rotation of the movable needle seat 704. In one example, the needle seat interface 742 includes a first concave surface 744 and a second concave surface 746. The first concave surface 744 provides a stop or contact surface for the movable needle seat 704, which limits the movement or rotation of the movable needle seat 704. In one example, the first concave surface 744 has a curvature shaped to mate with the outer surface of the movable needle seat 704. However, it should be noted that the first concave surface 744 can have any desired shape to provide a stop for the movement of the movable needle seat 704. The second concave surface 746 has a shape configured to match the outer surface of the annular guide 220 of the movable needle seat 704. The second concave surface 746 limits the further advancement or movement of the cannula 142, for example, when the inner housing 702 is compressed by an external force. In an example where the inner housing 702 is compressed by an external force, the outer surface of the annular guide 220 contacts the second concave surface 746.

[0119] Since the components of the infusion unit 700 are substantially the same as those of the infusion unit 112 discussed with respect to Figures 1-9 the differences between the components of the infusion unit 112 and the infusion unit 700 will only be discussed in detail here. Generally, in order to assemble the infusion unit 700 and couple the tube 110 to the infusion unit 700, in one example, with the movable needle seat 704 formed, the movable needle seat 704 is positioned on the biasing member 134. With the inner housing 132 formed, the first end 116 of the tube 110 is fixedly coupled to the tube receiving portion 716 of the inner housing 702. Generally, before firmly coupling the tube 110 to the inner housing 702, the connector assembly 114 is coupled to the second end 118 of the tube 110. With the tube 110 attached, the inner housing 702 is snapped into the base 706 such that the movable needle seat 704 and the biasing member 134 are sandwiched between the base 706 and the inner housing 702, and a portion of the tube 110 extends through the clearance hole 176. With the outer housing 130 formed, the outer housing 130 is positioned around the inner housing 132, and a portion of the tube 110 is received within the retaining notch 166 such that this portion of the tube 110 extends substantially around the circumference of the outer housing 130, adjacent to the periphery of the outer housing 130. By forming the coupling device 140, the mounting layer 270 is fixedly coupled to each of the second base surface 232 and the surface 162b of the bottom 162 of the retaining flange 148. The tube 110 can be connected to the infusion unit 700, where the connector 110b and the connector assembly 114 in the pipeline are connected to the tube 110 such that once the tube 110 is coupled to the assembled infusion unit 700, the infusion kit 104 is formed.

[0120] Since the installation of the infusion unit 700 on the user is with respect to Figures 1-9The installation of the infusion unit 112 discussed on the user is basically the same, and the installation of the infusion unit 700 will not be discussed in detail here.

[0121] It will be understood that the fluid infusion system 100 described with reference to Figures 1-15 can be configured differently to provide a fluid flow path from the fluid reservoir to the user's body. In one example, referring to Figure 16 , the fluid infusion system 800 is shown. The fluid infusion system 800 includes two main components: a fluid infusion device 802 (e.g., an insulin patch pump) and an infusion unit 804 disposed within and fluidly coupled to the fluid infusion device 802. Thus, in this example, the fluid infusion device 802 and the infusion unit 804 are coupled to the user's body. In this example, the fluid infusion device 802 houses an internal fluid reservoir 806 for the fluid to be delivered to the user. The tube 808 represents the fluid flow path that couples the fluid reservoir 806 to the infusion unit 804. When installed as depicted in Figure 16 , the tube 808 extends from within the fluid reservoir 806 to the internal infusion unit 804, which in turn provides a fluid passage to the user's body through the cannula 142.

[0122] The infusion unit 804 delivers the fluid received through the tube 808 from the fluid reservoir 806 associated with the fluid infusion device 802 into the user's body. Since the infusion unit 804 includes components that are substantially similar or identical to the infusion unit 112 discussed with respect to Figures 1-9 , the same reference numerals will be used to refer to the same or similar features. In this example, the infusion unit 804 includes a second or internal housing 132, a biasing member 134, a gimbal member or movable needle hub 136, a base 138, and a needle or metal cannula 142. It should be noted that although the biasing member 134 is described herein as being included in the infusion unit 112, the biasing member 134 may be optional. The infusion unit 804 provides a fluid flow path from the fluid reservoir 806 to the user's body through the cannula 142, which is movable relative to the fluid infusion device 802.

[0123] Thus, the infusion unit 804 associated with the fluid infusion device 802 provides a pivotable metal cannula 142 having a blunt second cannula end 282 that can reduce tissue inflammation because the metal cannula 142 does not pierce tissue when the infusion unit 804 and / or the fluid injection device 802 is subjected to an external force or load, and does not pierce tissue when the metal cannula 142 moves or pivots. Additionally, the use of titanium, nitinol, or a titanium alloy for the metal cannula 142 imparts flexibility to the metal cannula 142 of the infusion unit 804 while maintaining the metal cannula 142's resistance to bending and kinking, which reduces tissue damage and inflammation and can result in a longer service life.

[0124] It will be understood that Figures 1-15 the fluid infusion system 100 described with reference to Figure 16A , a fluid infusion system 900 is shown. The fluid infusion system 900 includes two main components: a fluid infusion device 902 (e.g., an insulin patch pump) and an infusion unit 904 disposed within and fluidly coupled to the fluid infusion device 902. Thus, in this example, the fluid infusion device 902 and the infusion unit 904 are coupled to the user's body. In this example, the fluid infusion device 902 houses an internal fluid reservoir 906 for the fluid to be delivered to the user. The tube 908 represents the fluid flow path that couples the fluid reservoir 906 to the infusion unit 904. When installed as Figure 16A depicted, the tube 908 extends from within the fluid reservoir 906 to the internal infusion unit 904, which in turn provides a fluid passage to the user's body through the cannula 512.

[0125] The infusion unit 904 delivers the fluid received through the tube 908 from the fluid reservoir 906 associated with the fluid infusion device 902 into the user's body. Since the infusion unit 904 includes components that are substantially similar or identical to those of the infusion unit 500 discussed with respect to Figures 10-14 , the same reference numerals will be used to refer to the same or similar features. In this example, the infusion unit 904 includes a second or internal housing 506, a base 508, and a needle or metal cannula 512. The infusion unit 904 provides a fluid flow path from the fluid reservoir 906 to the user's body through the cannula 512, which is movable relative to the fluid infusion device 902.

[0126] Thus, the infusion unit 904 associated with the fluid infusion device 902 provides a pivotable metal cannula 512 having a blunt second cannula end 282 that can reduce tissue inflammation because the metal cannula 512 does not pierce tissue when the infusion unit 904 and / or the fluid injection device 902 is subjected to an external force or load, and does not pierce tissue when the metal cannula 512 is moved or pivoted. Additionally, the use of titanium, nitinol, or a titanium alloy for the metal cannula 512 imparts flexibility to the metal cannula 512 of the infusion unit 904 while maintaining the metal cannula 512's resistance to bending and kinking, which reduces tissue damage and inflammation and can result in a longer service life.

[0127] In addition, the following examples are provided and numbered for ease of reference:

[0128] 1. An infusion set for use with a fluid infusion device having a fluid reservoir, the infusion set comprising: a cannula providing a fluid flow path; a first housing including a gimbal member coupled to the cannula, the gimbal member being pivotable relative to the first housing to move the cannula relative to the first housing, and the first housing being coupled to a fluid supply line to supply fluid to the cannula, the fluid supply line being connected to the fluid reservoir to receive fluid; and a second housing separated from the first housing, the second housing surrounding the first housing and accommodating a portion of the fluid supply line.

[0129] 2. The infusion set of Example 1, wherein the cannula is coupled to the gimbal member so as to extend along an axis substantially transverse to a vertical axis extending through the infusion set, and the gimbal member moves the cannula about the axis.

[0130] 3. The infusion set of Example 1 or 2, wherein the first housing includes a first gimbal surface, and the gimbal member is a movable needle hub received within the first housing and having a second gimbal surface that mates with the first gimbal surface to move the cannula.

[0131] 4. The infusion set of Example 1, 2, or 3, further comprising a biasing member that contacts at least a portion of the movable needle hub and applies a force to the movable needle hub to return the movable needle hub to an intermediate position.

[0132] 5. The infusion set of Example 1 or 2, further comprising a base coupled to the first housing, and the gimbal member is coupled between the first housing and the base.

[0133] 6. The infusion set of Example 1, 2, or 5, wherein the gimbal member is a spherical ball.

[0134] 7. The infusion set of Example 1, 2, 3, 4, 5, or 6, further comprising a coupling device for removably coupling the infusion set to an anatomical structure, the coupling device including an adhesive layer having a plurality of pedal-like portions extending radially outward from a central portion.

[0135] 8. The infusion set of Example 7, wherein the first housing and the second housing are each coupled to the coupling device.

[0136] 9. The infusion set of Example 1, 2, 3, 4, 5, 6, 7, or 8, wherein the cannula is constructed of metal or a metal alloy and includes a blunt tip.

[0137] 10. The infusion set of Example 9, wherein the blunt tip of the cannula includes a slot.

[0138] 11. An infusion set of Examples 1, 2, 3, 4, 5, 6, 7, 8, 9 or 10, wherein the fluid infusion device is an insulin infusion device, and the cannula of the infusion set is in fluid communication with the fluid reservoir associated with the insulin infusion device through the fluid supply line.

[0139] 12. An infusion set of Examples 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 or 11, wherein the second housing includes a plurality of retaining flanges that cooperate to receive a portion of the fluid supply line such that the portion of the fluid supply line is positioned around at least a portion of the circumference of the second housing.

[0140] 13. An infusion set for use with a fluid infusion device having a fluid reservoir, the infusion set comprising: a cannula providing a fluid flow path; a first housing including an articulating member coupled to the cannula, the articulating member being pivotable relative to the first housing to move the cannula relative to the first housing, and the first housing being coupled to a fluid supply line to supply fluid to the cannula, the fluid supply line being connected to the fluid reservoir to receive fluid; and a second housing separated from and surrounding the first housing, the second housing having a plurality of retaining flanges that cooperate to receive a portion of the fluid supply line such that the portion of the fluid supply line is positioned around the circumference of the second housing.

[0141] 14. The infusion set of Example 13, wherein the first housing includes a first articulating surface and the articulating member is a movable needle hub that is received within the first housing and has a second articulating surface that mates with the first articulating surface to move the cannula.

[0142] 15. The infusion set of Example 13 or 14, further comprising a biasing member that contacts at least a portion of the movable needle hub and applies a force to the movable needle hub to return the movable needle hub to an intermediate position.

[0143] 16. The infusion set of Example 13, 14 or 15, further comprising a base coupled to the first housing, and the articulating member is coupled between the first housing and the base.

[0144] 17. The infusion set of Example 13, wherein the articulating member is a spherical ball.

[0145] 18. The infusion set of Example 13, 14, 15, 16 or 17, further comprising a coupling device for removably coupling the infusion set to an anatomical structure, the coupling device including an adhesive layer having a plurality of pedal-like portions extending radially outward from a central portion.

[0146] 19. The infusion set of Example 18, wherein the first housing and the second housing are each coupled to the coupling device.

[0147] 20. An infusion set for use with a fluid infusion device having a fluid reservoir, the infusion set comprising: a metal cannula that provides a fluid flow path; a first housing that includes a gimbal member coupled to the cannula, the gimbal member being pivotable relative to the first housing to move the cannula relative to the first housing, and the first housing being coupled to a fluid supply line to supply fluid to the cannula, the fluid supply line being connected to the fluid reservoir to receive fluid; a second housing that is separate from and surrounds the first housing, the second housing having a plurality of retaining flanges that cooperate to receive a portion of the fluid supply line such that the portion of the fluid supply line is positioned around the circumference of the second housing; and a coupling device for removably coupling the infusion set to an anatomical structure, the coupling device including an adhesive layer having a plurality of pedal-shaped portions extending radially outward from a central portion, wherein the first housing and the second housing are each coupled to the coupling device.

[0148] Although at least one exemplary embodiment has been presented in the foregoing detailed description, it should be understood that a vast number of variations exist. It should also be understood that one or more of the exemplary embodiments described herein are not intended to limit in any way the scope, applicability, or configuration of the claimed subject matter. Rather, the foregoing detailed description will provide those skilled in the art with a convenient guide for implementing one or more of the described embodiments. It should be understood that various changes may be made to the function and arrangement of the elements without departing from the scope defined by the claims, including equivalents and foreseeable equivalents known at the time of filing this patent application.

Claims

1. An infusion set for use with a fluid infusion device having a fluid reservoir, the infusion set comprising: an insertion tube that provides a fluid flow path; a joint movement member that couples the insertion tube; a biasing member; a base; a first housing that is coupled to the base to define a chamber that houses the joint movement member and the biasing member, wherein the joint movement member is coupled between the first housing and the base and is pivotable relative to the first housing to move the insertion tube relative to the first housing, and the first housing is coupled to a fluid supply line to supply fluid to the insertion tube, the fluid supply line being connected to the fluid reservoir to receive fluid; and a second housing that is separated from and surrounds the first housing, the second housing having a plurality of retaining flanges that cooperate to receive a portion of the fluid supply line such that the portion of the fluid supply line is positioned around the circumference of the second housing; wherein an inner surface of the first housing includes a biasing member clearance surface and a first joint movement surface, the biasing member clearance surface extending around the circumference of the first housing on the inner surface, the first joint movement surface being offset relative to a central axis of the first housing; and, the joint movement member is a movable needle hub that is received within the first housing and has a second joint movement surface that mates with the first joint movement surface to move the insertion tube; the biasing member contacts at least a portion of the movable needle hub and applies a force to the movable needle hub to return the movable needle hub to an intermediate position.

2. The infusion set of claim 1, wherein the joint movement member is a spherical ball.

3. The infusion set of claim 1, further comprising a coupling device for removably coupling the infusion set to an anatomical structure, the coupling device including an adhesive layer having a plurality of pedal-like portions that extend radially outward from a central portion.

4. The infusion set of claim 3, wherein the first housing and the second housing are each coupled to the coupling device.

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