Needle hubs for drug delivery devices

Abstract

A needle hub for a drug delivery device includes a hub body, an activation button, a needle holder and a needle attached to the needle holder, a cannula holder and a cannula attached to the cannula holder, a needle actuation mechanism configured to move the needle holder and the cannula holder from a retracted position to an insertion position and configured to retract the needle holder to the retracted position, and a cannula spring that biases the cannula holder to the retracted position. Movement of the activation button is configured to cause the needle holder and the cannula holder to move from the retracted position to the insertion position, with the needle holder returning to the retracted position while the cannula holder remains in the insertion position.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Application No. 63 / 134,054, filed January 5, 2021, which is incorporated herein by reference in its entirety.

[0002] FIELD OF THE INVENTION The present disclosure relates to a needle hub for a drug delivery device. [Background technology]

[0003] 2. Description of Related Art Wearable medical devices, such as auto-injectors, have the advantage of being able to provide treatment to patients at locations away from a clinical facility and / or while worn separately under the patient's clothing. The wearable medical device may be configured to be applied to the patient's skin and to automatically deliver a dose of a pharmaceutical composition within a predetermined time after application of the wearable medical device to the patient's skin. After the device delivers the pharmaceutical composition to the patient, the patient may then remove and discard the device. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] US Patent Application Publication No. 2017 / 0354788 Summary of the Invention [Problem to be solved by the invention]

[0005] A needle hub for a drug delivery device is provided. [Means for solving the problem]

[0006] Summary of the Invention In one aspect or embodiment, a needle hub for a drug delivery device includes a hub body, an activation button, a needle holder and a needle attached to the needle holder, a cannula holder and a cannula attached to the cannula holder, a needle actuator configured to move the needle holder and the cannula holder from a retracted position to an insertion position and configured to retract the needle holder to the retracted position, and a cannula spring that biases the cannula holder to the retracted position. The needle actuation mechanism includes a cam track, a cam member received within the cam track, and a torsion spring that biases the cam member against the cam track. Movement of the activation button is configured to cause the needle holder and the cannula holder to move from the retracted position to the insertion position, and the needle holder is configured to return to the retracted position while the cannula holder remains in the insertion position.

[0007] The hub body may include a cannula lock configured to lock the cannula holder in an insertion position. The needle hub may include an adhesive pad configured to secure the hub body to a person's skin surface, the adhesive pad including a release tab. Movement of the release tab releases the cannula lock and Cannula Holder and allowing the cannula holder to return to the retracted position. The cannula lock may be biased away from the cannula holder via a lock spring, and the hub body includes a hinge portion configured to rotate with movement of the release tab to disengage the cannula lock.

[0008] The cannula holder may include a port configured to be in fluid communication with a fluid source, the cannula being in fluid communication with the port. The needle hub may further include a tube connected to the port of the cannula holder. The cannula holder may include a seal that engages the needle. At least a portion of the needle may be received within the cannula.

[0009] The needle hub may further include a skin tenting reduction mechanism including an adhesive surface configured to be adhered to a person's skin surface, the skin tenting reduction mechanism configured to stretch the skin surface at the location where the needle pierces the skin surface.

[0010] The above and other features and advantages of the present disclosure, as well as the manner in which they are achieved, will become more apparent, and the disclosure itself will be better understood, by reference to the following description of embodiments of the disclosure, taken in conjunction with the accompanying drawings. [Brief explanation of the drawings]

[0011] [Figure 1] 1 is a schematic diagram of a drug delivery device according to one aspect or embodiment of the present application. [Figure 2] FIG. 2 is a schematic diagram of the drug delivery device of FIG. 1. [Figure 3] FIG. 1 is a perspective view of a needle hub according to one aspect or embodiment of the present application. [Figure 4A] FIG. 4 is a top view of the needle hub of FIG. 3 showing the pre-use indicator of the needle hub. [Figure 4B] FIG. 4 is a top view of the needle hub of FIG. 3 showing the indicator after needle insertion. [Figure 4C] FIG. 4 is a top view of the needle hub of FIG. 3 showing the indicator after cannula withdrawal. [Figure 5] 4 is a schematic diagram illustrating a method of using the needle hub of FIG. 3. FIG. [Figure 6A] FIG. 4 is a schematic diagram of the needle hub of FIG. 3 showing actuation of the activation button. [Figure 6B] 4 is a schematic diagram of the needle hub of FIG. 3 showing movement of the needle and cannula from a retracted position to an inserted position. [Figure 6C] FIG. 4 is a schematic diagram of the needle hub of FIG. 3 showing the needle in a retracted position and the cannula in an inserted position. [Figure 6D] FIG. 4 is a schematic view of the needle hub of FIG. 3 showing the movement of the cannula to a retracted position. [Figure 7] FIG. 10 is a perspective view of a needle hub according to a further aspect or embodiment of the present application. [Figure 8] FIG. 8 is a front view of the needle hub of FIG. 7, showing the injection mode. [Figure 9] FIG. 8 is a front view of the needle hub of FIG. 7 showing withdrawal of the cannula. [Figure 10] FIG. 10 is a perspective view of a needle hub according to a further aspect or embodiment of the present application. [Figure 11] 8 is a schematic diagram showing a method of using the needle hub of FIG. 7. FIG. [Figure 12A] FIG. 8 is a schematic diagram of the needle hub of FIG. 7, showing the needle hub in a pre-use position. [Figure 12B] FIG. 8 is a schematic diagram of the needle hub of FIG. 7 showing the needle hub actuated. [Figure 12C] FIG. 8 is a schematic diagram of the needle hub of FIG. 7 showing the needle being retracted. [Figure 12D] FIG. 8 is a schematic diagram of the needle hub of FIG. 7 showing the needle in a retracted position. [Figure 12E] FIG. 8 is a schematic view of the needle hub of FIG. 7 showing the applicator removed from the needle hub. [Figure 12F] FIG. 8 is a schematic view of the needle hub of FIG. 7 showing the cannula in a retracted position. [Figure 13] FIG. 10 is a cross-sectional view of a needle hub according to a further aspect or embodiment of the present application. [Figure 14] FIG. 14 is a cross-sectional view of the needle hub of FIG. [Figure 15] FIG. 10 is a perspective view of a needle hub according to a further aspect or embodiment of the present application. [Figure 16] FIG. 10 is a perspective view of a needle hub according to a further aspect or embodiment of the present application. [Figure 17] FIG. 1 is a perspective view of a needle actuation assembly according to one aspect or embodiment of the present application; [Figure 18A] FIG. 16 is a cross-sectional view of the needle hub of FIG. 15 showing the cannula insertion position. [Figure 18B] FIG. 16 is a cross-sectional view of the needle hub of FIG. 15, showing the cannula in a retracted position. [Figure 19] FIG. 10 is a perspective view of a needle hub according to a further aspect or embodiment of the present application. [Figure 20]20 is a schematic diagram showing how the needle hub of FIG. 19 is used. [Figure 21] FIG. 10 is a perspective view of a needle actuation assembly according to a further aspect or embodiment of the present application. [Figure 22] FIG. 10 is a perspective view of a drug delivery device and a needle hub according to a further aspect or embodiment of the present application. [Figure 23] FIG. 23 is an exploded perspective view of the drug delivery device and needle hub of FIG. 22. [Figure 24] FIG. 23 is a perspective view of the drug delivery device and needle hub of FIG. 22, showing the drug delivery device and needle hub coupled during delivery of a medicament. [Figure 25] FIG. 23 is a perspective view of the drug delivery device and needle hub of FIG. 22, showing the needle hub separated from the drug delivery device during drug delivery. [Figure 26A] FIG. 10 is a cross-sectional view of a needle hub according to a further aspect or embodiment of the present application, showing an initial position of the needle hub. [Figure 26B] FIG. 10 is a cross-sectional view of a needle hub according to a further aspect or embodiment of the present application showing engagement with a skin surface. [Figure 26C] FIG. 10 is a cross-sectional view of a needle hub according to a further aspect or embodiment of the present application showing needle insertion. [Figure 27A] FIG. 10 is a cross-sectional view of a needle hub according to a further aspect or embodiment of the present application, showing an initial position of the needle hub. [Figure 27B] FIG. 10 is a cross-sectional view of a needle hub according to a further aspect or embodiment of the present application showing engagement with a skin surface. [Figure 27C] FIG. 10 is a cross-sectional view of a needle hub according to a further aspect or embodiment of the present application showing needle insertion. [Figure 28A] FIG. 10 is a cross-sectional view of a needle hub according to a further aspect or embodiment of the present application, showing an initial position of the needle hub. [Figure 28B] FIG. 10 is a cross-sectional view of a needle hub according to a further aspect or embodiment of the present application showing engagement with a skin surface. [Figure 28C] FIG. 10 is a cross-sectional view of a needle hub according to a further aspect or embodiment of the present application showing needle insertion. [Figure 29] FIG. 10 is a perspective view of a needle actuation assembly according to a further aspect or embodiment of the present application, showing an unactuated position. [Figure 30] FIG. 30 is a perspective view of the needle actuation assembly of FIG. 29, showing the actuated position. [Figure 31] FIG. 30 is a cross-sectional view of the needle actuation assembly of FIG. 29, showing the unactuated position. [Figure 32] FIG. 30 is a cross-sectional view of the needle actuation assembly of FIG. 29, showing the actuated position. [Figure 33] FIG. 30 is a cross-sectional view of the needle actuation assembly of FIG. 29, showing the retracted position. [Figure 34] FIG. 10 is a perspective view of a needle hub according to a further aspect or embodiment of the present application. [Figure 35] FIG. 35 is a schematic diagram of the needle hub of FIG. [Figure 36] FIG. 10 is a perspective view of a drug delivery device according to a further aspect or embodiment of the present application. [Figure 37] FIG. 37 is a front view of the drug delivery device of FIG. 36. [Figure 38] FIG. 37 is a front view of the drug delivery device of FIG. 36 showing the reservoir separated from the drug delivery device. [Figure 39] FIG. 37 is a front view of the drug delivery device of FIG. 36, showing the drug delivery device attached to a patient. [Figure 40] 1 is a partial cross-sectional view of a prior art valve assembly. DETAILED DESCRIPTION OF THE INVENTION

[0012] Corresponding reference characters indicate corresponding parts throughout the several views. The exemplifications set forth herein illustrate exemplary embodiments of the present disclosure, and such exemplifications should not be construed as limiting the scope of the present disclosure in any way.

[0013] Detailed Description of the Invention Spatial or directional terms such as "left," "right," "inside," "outside," "upper," and "lower" should not be considered limiting as the present invention may assume various alternative orientations.

[0014] All numbers used in this specification and claims should be understood to be modified in all instances by the term "about." By "about" is meant a range of plus or minus ten percent of the stated value. As used in this specification and claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. The terms "first," "second," and similar terms are not intended to refer to a particular order or sequence in time, but instead refer to different conditions, characteristics, or elements. By "at least" is meant "greater than or equal to."

[0015] 1-3 , the drug delivery device 10 includes a reservoir 12, a power module 14, an insertion mechanism 16, control electronics 18, and a housing 20. In one aspect or embodiment, the drug delivery device 10 is a wearable auto-injector. The drug delivery device 10 can be attached to a patient's skin and triggered to inject a pharmaceutical composition from the reservoir 12 into the patient. The drug delivery device 10 can be pre-filled with the pharmaceutical composition or can be filled with the pharmaceutical composition by the patient or a medical professional prior to use. The control electronics 18 can include a processor 22, such as a microcontroller, a motor driver 23, a sensing module 24, a visual driver 25, and / or an audio driver 26. The drug delivery device 10 includes a drive mechanism 27 configured to dispense fluid from the reservoir 12. The drive mechanism 27 can be motor-driven, spring-driven, hydraulically driven, pneumatically driven, and / or other suitable drive mechanisms.

[0016] The drug delivery device 10 is configured to deliver a dose of a pharmaceutical composition, such as any desired drug, into a patient's body via subcutaneous injection at a slow, controlled infusion rate. An exemplary delivery time achieved by the drug delivery device 10 can range from about 5 minutes to about 60 minutes, but is not limited to this exemplary range. An exemplary volume of the pharmaceutical composition delivered by the drug delivery device 10 can range from about 10 milliliters to about 50 milliliters, but is not limited to this exemplary range. The amount of pharmaceutical composition delivered to the patient can be adjusted. The device 10 can communicate with another device, such as a mobile device or a computer.

[0017] 3-6D, according to one aspect or embodiment, the insertion mechanism 16 includes a needle hub 30 that is separate from the housing 20. The needle hub 30 includes a removal tab 32, an activation button 34, a status indicator 36, finger grips, side grips, and an integrated cannula withdrawal tab 38. The needle hub 30 includes an indwelling cannula. The status indicator 36 can be white when unused (FIG. 4A), blue when the needle is inserted and ready for injection (FIG. 4B), or green when the cannula is withdrawn (FIG. 4C). As shown in FIG. 5, the needle hub 30 is used by removing the packaging, removing the adhesive liner from the bottom of the needle hub 30, attaching the needle hub 30 to the skin surface, and depressing the activation button 34, which automatically retracts the needle, leaving the indwelling cannula in the patient. Medication or fluid is then injected into the patient. Once the injection is complete, the cannula withdrawal tab 38 is pulled, which retracts the cannula, after which the needle hub 30 can be removed from the patient's skin.

[0018] 6A-6D , in one aspect or embodiment, the needle hub 30 includes a hub body 42, an activation button 34, a needle holder 44, a needle 46 attached to the needle holder 44, a needle spring 48, a cannula holder 50, a cannula 52 attached to the cannula holder 50, and a cannula spring 54. The activation button 34 is movable relative to the hub body 42 and has a first actuation surface 56. The needle holder 44 is movable relative to the hub body 42 and has a second actuation surface 58. The first actuation surface 56 of the activation button 34 is configured to engage the second actuation surface 58 of the needle holder 44. The needle spring 48 biases the needle holder 44 to a retracted position in which the needle 46 is positioned within the hub body 42. The cannula holder 50 is movable relative to the hub body 42 and the needle holder 44. Cannula 52 is configured to be in fluid communication with a fluid source, such as fluid reservoir 12. Cannula spring 54 biases cannula holder 50 to a retracted position in which cannula 52 is positioned within hub body 42. Movement of activation button 34 is configured to cause first actuation surface 56 of activation button 34 to engage second actuation surface 58 of needle holder 44, moving needle holder 44 and cannula holder 50 from their respective retracted positions to an inserted position in which the distal ends of needle 46 and cannula 52 are positioned outside hub body 42; needle holder 44 is configured to return to the retracted position while cannula holder 50 remains in the inserted position. Movement of a portion of hub body 42 is configured to release the coupling between cannula holder 50 and hub body 42, allowing cannula holder 50 to return to the retracted position.

[0019] 6A-6D , needle holder 44 includes a passageway 60 configured to be in fluid communication with fluid reservoir 12, and needle 46 is in fluid communication with passageway 60 of needle holder 44. At least a portion of needle 46 is received within cannula 52. Fluid is configured to flow from fluid reservoir 12, through tubing 62, into passageway 60 of needle holder 44, through needle 46, and into cannula 52. Cannula holder 50 includes a seal 64 that engages with needle 46. Needle hub 30 includes a first protrusion 66, and cannula holder 50 includes a second protrusion 68, such that when cannula 52 is in the insertion position, first protrusion 66 of needle hub 30 engages second protrusion 68 of cannula holder 50 to limit movement of cannula holder 50 to the retracted position.

[0020] 3-6D , the needle hub 30 includes a detachment tab 70, and movement of the detachment tab 70 disengages the first protrusion 66 of the needle hub 30 from the second protrusion 68 of the cannula holder 50, allowing the cannula spring 54 to bias the cannula 52 to the retracted position. At least a portion of the detachment tab 70 is configured to engage a person's skin surface after the needle hub 30 is attached to the person. The activation button 34 is movable along a first axis 72, and the needle holder 44 and cannula holder 50 are movable along a second axis 74 that is perpendicular to the first axis 72. The first actuation surface 56 of the activation button 34 is configured to disengage from the second actuation surface 58 of the needle holder 44 after movement of the activation button 34 a predetermined distance along the first axis 72.

[0021] 7-14 , a needle hub 80 according to a further aspect or embodiment includes an applicator 82 having a needle holder 84, a needle 86 attached to the needle holder 84, a needle retraction spring 88, and an activation button 90, and a hub body 92 having a cannula holder 94, a cannula 96 attached to the cannula holder 94, a cannula withdrawal button 98, and a cannula retraction spring 100. At least a portion of the hub body 92 is configured to be received within the applicator 82, and the applicator 82 is configured to be separated from the hub body 92. Movement of activation button 90 is configured to move needle holder 84 and cannula holder 94 from a retracted position, in which needle 86 and cannula 96 are positioned within applicator 82 or hub body 92, to an inserted position, in which the distal ends of needle 86 and cannula 96 are positioned outside of applicator 82 and hub body 92. Cannula withdrawal button 98 locks cannula holder 94 in the inserted position against the biasing force of cannula retraction spring 100 when cannula holder 94 is moved from the retracted position to the inserted position. As shown in FIG. 10 , in one aspect or embodiment, cannula withdrawal button 98 may be omitted.

[0022] 12A-12F, needle holder 84 is configured to move to a retracted position after movement of cannula holder 94 to the insertion position. Activation button 90 includes an extension 102 having a drive lug 103, and the applicator includes a drive surface 104 configured to engage with drive lug 103. Upon movement of activation button 90, drive lug 103 engages needle holder 84, moving needle holder 84 and cannula holder 94 to the insertion position, and drive lug 103 engages drive surface 104 of applicator 82, moving extension 102 radially outward, thereby releasing needle holder 84 from drive lug 103 and allowing needle retraction spring 88 to return needle holder 84 to the retracted position. Actuation of cannula withdrawal button 98 is configured to move cannula holder 94 from the insertion position to the retracted position. Hub body 92 further includes an adhesive pad 105 configured to secure hub body 92 to a person's skin surface. Adhesive pad 105 includes a detachment tab 106 extending radially outward from hub body 92. Activation button 90 is received within an opening 107 defined by a body 108 of applicator 82. Cannula holder 94 includes a port 109 configured to be in fluid communication with fluid reservoir 12, and cannula 96 is in fluid communication with port 109. Tube 110 is connected to the port of cannula holder 94.

[0023] 11 , in one aspect or embodiment, the needle hub 80 is used by removing the packaging, removing the adhesive liner, attaching the needle hub 80 to a patient's skin surface, removing the safety cap, and pressing the activation button 90 on the applicator 82, which automatically activates and retracts the needle 86, leaving behind an indwelling cannula 96. The applicator 82 can then be detached from the hub body 92 and an injection can begin. Once the injection is complete, the cannula withdrawal button 98 can be pressed to remove the cannula 96 from the patient, and the hub body 92 is removed from the patient's skin using the removal tab 106.

[0024] 13 and 14, in one aspect or embodiment, cannula holder 94 includes a portion of adhesive pad 105, which detaches the portion of adhesive pad 105 from the patient's skin when cannula holder 94 is removed from hub body 92, facilitating easy removal of the remainder of adhesive pad 105 from the patient's skin.

[0025] 15-18B , according to a further aspect or embodiment, a needle hub 112 includes a hub body 114, an activation button 116, a needle holder 118 and a needle 120 attached to the needle holder 118, a cannula holder 122 and a cannula 124 attached to the cannula holder 122, a needle actuation mechanism 126, and a cannula spring 128. The needle actuation mechanism 126 is configured to move the needle holder 118 and the cannula holder 122 from the retracted position to the insertion position and to retract the needle holder 118 to the retracted position. The needle actuation mechanism 126 includes a cam track 130, a cam member 132 received within the cam track 130, and a torsion spring. The torsion spring 134 biases the cam member 132 against the cam track 130. The cannula spring 128 biases the cannula holder 122 to the retracted position. Movement of activation button 116 is configured to cause needle holder 118 and cannula holder 122 to move from the retracted position to the insertion position, with needle holder 118 returning to the retracted position while cannula holder 122 remains in the insertion position. As shown in FIG. 16 , in one aspect or embodiment, needle hub 112 includes two lateral actuation push buttons 116. Needle hub 112 is used in the same manner as described above in connection with needle hub 30 shown in FIG. 5 .

[0026] 17-18B, hub body 114 includes a cannula lock 136 configured to lock cannula holder 122 in an insertion position. Needle hub 112 includes an adhesive pad 138 configured to secure hub body 114 to a person's skin surface, and adhesive pad 138 includes a release tab 140. Movement of release tab 140 releases cannula lock 136 and Cannula holder 122The cannula holder 122 is configured to disengage from the cannula lock 136 and allow the cannula holder 122 to return to the retracted position. The cannula lock 136 is biased away from the cannula holder 122 via a lock spring 142, and the hub body 114 includes a hinged portion 144 that is configured to rotate with movement of the removal tab 140 to release the cannula lock 136. The cannula holder 122 includes a port 146 configured to be in fluid communication with the fluid reservoir 12, and the cannula 124 is in fluid communication with the port 146. The needle hub 112 includes a tube 148 connected to the port 146 of the cannula holder 122. The cannula holder 122 includes a seal 150 that engages with the needle 120, at least a portion of which is received within the cannula 124.

[0027] 19-21 , according to a further aspect or embodiment, a needle hub 152 includes a needle holder 154, a needle 156 attached to the needle holder 154, a needle actuation assembly 158 configured to move the needle holder 154 from a retracted position to an insertion position and then retract the needle holder 154 to the retracted position, and a pressure interlock 160 including an inlet 162 configured to be in fluid communication with the fluid reservoir 12, an outlet 164 in fluid communication with the needle 156, and a locking member 166. The locking member 166 has a first position in which the locking member 166 prevents actuation of the needle actuation assembly 158 and a second position in which the locking member 166 allows actuation of the needle actuation assembly 158. The locking member 166 is moved from the first position to the second position based on pressure in the pressure interlock 160.

[0028] 21 , when locking member 166 is in the first position, locking member 166 isolates inlet 162 from outlet 164, and when locking member 166 is in the second position, locking member 166 allows fluid communication between inlet 162 and outlet 164. Needle hub 152 further includes a tube 168 connected to outlet 164 and in fluid communication with needle 156. Locking member 166 includes an opening 170, and when locking member 166 is in the second position, a portion of needle actuation assembly 158 extends through opening 170 in locking member 166. Needle actuation assembly 158 includes a cam track 172, a cam member 174, and an actuation spring 176 that biases cam member 174 against cam track 172. Cam block 178 defines cam track 172, and when locking member 166 is in the second position, cam block 178 extends through opening 170 in locking member 166. Needle actuation assembly 158 further includes a cannula 180, and when needle holder 156 is in the retracted position, needle 156 is received within cannula 180.

[0029] 19-21 , needle hub 152 includes housing 182 and removal tab 184. Top surface 186 of housing 182 is smooth and lacks an activation button. As shown in FIG. 20 , needle hub 152 is used by removing the packaging, removing the adhesive liner, attaching needle hub 152 to the patient's skin surface, and activating drive mechanism 27 to insert needle 156, which automatically retracts, leaving indwelling cannula 180. After the injection is complete, needle hub 152 is removed by grasping and lifting removal tab 184 upward, and cannula 180 automatically retracts. In one aspect or embodiment, pulling removal tab 184 causes a reduction in pressure in pressure interlock 160, resulting in the cannula holder and / or cannula 180 automatically retracting.

[0030] 22-25, a drug delivery device 190 and a needle hub 192 are shown according to a further aspect or embodiment. The drug delivery device 190 may be similar to the drug delivery device 10 shown in FIGS. 1 and 2. However, the drug delivery device 190 and the needle hub 192 of FIGS. 22-25 are modular, with the needle hub 192 optionally integrated within the drug delivery device 190 (FIG. 24) or the needle hub 192 being separate from the drug delivery device 190 and separately attached to the patient's skin surface (FIG. 25). In one aspect or embodiment, the drug delivery device 190 and the needle hub 192 can remain coupled or integrated for smaller drug amounts and be separated, with a fluid connection between them, for larger drug amounts.

[0031] 26A-26C, a needle hub 200 with a skin tenting reduction mechanism is shown, according to one aspect or embodiment. The needle hub 200 includes a rotating engagement mechanism 202, a portion of which initially contacts and adheres to the patient's skin surface, and then further rotates when the needle hub 200 is fully pressed against the skin surface. The initial adhesion and further rotation of the rotating engagement mechanism stretches the skin and reduces skin tenting.

[0032] 27A-27C, a needle hub 204 with a skin tenting reduction mechanism is shown according to one aspect or embodiment. The needle hub 204 includes an adhesive ring 206 that presses against the skin prior to needle insertion when an activation button is pressed or actuated. The adhesive ring 206 stretches the skin, reducing skin tenting.

[0033] 28A-28C, a needle hub 208 with a skin tenting reduction mechanism is shown, according to one aspect or embodiment. The needle hub 208 includes a skin tensioning member 210 that is initially adhered to a patient's skin surface and then moved radially outward. An activation button 212 engages the skin tensioning member 210, causing it to move radially outward, which locally stretches the skin and reduces skin tenting.

[0034] The skin tenting reduction features and related features of Figures 26A-28C may be incorporated into any of the aspects or embodiments of the needle hub or needle insertion configurations disclosed herein.

[0035] 29-33 , according to one aspect or embodiment, needle actuation assembly 220 includes a clip 222 biased by a spring 228 that holds needle actuator body 224 and cannula body 226 in a retracted position. Pressing clip 222 inward releases needle actuator body 224 and cannula body 226, allowing insertion of needle 230 and cannula 232. When cannula body 226 reaches the bottom of housing 233, it contacts a ramp structure, causing cannula body 226 to rotate and / or twist. Cannula body 226 is held down by clip 236 on the wall of housing 233. After cannula body 226 has rotated and / or twisted, needle actuator body 224 is released and return spring 238 retracts needle 230.

[0036] 34 and 35 , according to a further aspect or embodiment, a needle hub 240 is configured to be disconnected from the remaining components of the drug delivery device. The needle hub 240 includes a protective cap 242, a needle insertion mechanism 244, a connection arrangement 246 and drive mechanism 27 configured to fluidly connect the needle hub 240 to the reservoir 12, a flow path 248, and an adhesive pad and / or layer 250. The connection arrangement 246 may provide a sterile connection between the needle hub 240 and the reservoir 12. Needle retraction may be activated manually or automatically via a trigger mechanism connected to the end of a dose event and / or via a wireless connection between the drive unit and the needle hub 240. The trigger mechanism may include a flexible-rigid connection to the plunger rod's movement (in whole or in part, at the end of movement). The flow path 248 and connection arrangement 246 are maintained sterile until a connection is established, including sterilization of the subsystem and the reservoir.

[0037] 36-39 , according to a further aspect or embodiment, a drug delivery device 252 includes a flexible reservoir 254, at least a portion of which is disposed externally from the remainder of the drug delivery device 252. The drug delivery device 252 may be similar to the drug delivery device 10 shown in FIGS. 1 and 2. As shown in FIG. 39 , for smaller volumes, such as 10 mL-30 mL, the flexible reservoir 254 may be attached directly to the drug delivery device 252 and worn on the patient's skin surface. As shown in FIG. 38 , for larger volumes, such as 50 mL, the flexible reservoir 254 may be separate from the drug delivery device 252 and fluidly connected to the drug delivery device 252 via a fluid path 256, such as a tube. The flexible reservoir 254 may be separately attached to the patient via a belt clip, harness, strap, or other suitable configuration.

[0038] 40, the drug delivery device of any of the above-described aspects or embodiments may utilize a valve assembly 260 that engages with the reservoir and / or container to facilitate fluid connection between the reservoir and / or container and a fluid path to the needle and / or cannula. The valve assembly 260 may be similar to and operate similarly to the valve assembly shown and described in U.S. Patent Application Publication No. 2009 / 0129990.

[0039] While the present invention has been described in detail for purposes of illustration, based on what are presently considered to be the most practical and preferred embodiments, it should be understood that such detail is for that purpose only, and the invention is not limited to the disclosed embodiments, but on the contrary is intended to cover modifications and equivalent arrangements within the spirit and scope of the appended claims. For example, it should be understood that the present invention contemplates that, to the extent possible, one or more features of any embodiment can be combined with one or more features of any other embodiment.

Claims

1. 1. A needle hub for a drug delivery device, the needle hub comprising: The hub body, Start button and a needle holder and a needle attached to the needle holder; a cannula holder and a cannula attached to the cannula holder; a needle actuation mechanism configured to move the needle holder and the cannula holder from a retracted position to an insertion position and configured to retract the needle holder to the retracted position, the needle actuation mechanism including a cam track, a cam member received in the cam track, and a torsion spring biasing the cam member against the cam track; a cannula spring that biases the cannula holder to the retracted position; an adhesive pad configured to secure the hub body to a human skin surface, the adhesive pad including a release tab; a hub body including a cannula lock configured to lock the cannula holder in the insertion position; movement of the activation button is configured to cause the needle holder and the cannula holder to move from the retracted position to the insertion position, the needle holder returning to the retracted position while the cannula holder remains in the insertion position; the hub body includes a cannula lock configured to lock the cannula holder in the insertion position; movement of the release tab is configured to disengage the cannula lock from the cannula holder to allow the cannula holder to return to the retracted position; the cannula lock is biased away from the cannula holder via a lock spring; and the hub body includes a hinge portion configured to rotate with movement of the release tab to disengage the cannula lock.

2. 10. The needle hub of claim 1, wherein the cannula holder includes a port configured to be in fluid communication with a fluid source, the cannula being in fluid communication with the port.

3. 3. The needle hub of claim 2, further comprising a tube connected to said port of said cannula holder.

4. 4. The needle hub of claim 3, wherein the cannula holder includes a seal that engages the needle.

5. 5. The needle hub of claim 4, wherein at least a portion of the needle is received within the cannula.

6. 10. The needle hub of claim 1, further comprising a skin tenting reduction mechanism including an adhesive surface configured to adhere to a human skin surface, the skin tenting reduction mechanism configured to stretch the skin surface at a location where the needle pierces the skin.

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