NEEDLE CONE WITH PRESSURE LOCK FOR DRUG DELIVERY DEVICE

Abstract

A needle hub for a drug delivery device includes a needle holder and a needle attached to the needle holder, a needle drive assembly configured to move the needle holder from a retracted position to an insertion position and back to the retracted position, and a pressure interlock comprising an inlet configured to be in fluid communication with a fluid source, an outlet in fluid communication with the needle, and a locking element. The locking element has a first position in which it prevents actuation of the needle drive assembly and a second position in which it permits actuation of the needle drive assembly. The locking element moves from the first position to the second position depending on the pressure within the pressure interlock.

Description

NEEDLE CONE WITH PRESSURE LOCK FOR DRUG DELIVERY DEVICE CROSS REFERENCE TO RELATED APPLICATION This application claims priority over U.S. Provisional Application numbers 63 / 134.054, filed on January 5, 2021, which is incorporated herein by reference in its entirety. BACKGROUND OF THE INVENTION Field of invention This disclosure relates to a needle hub for a drug delivery device. Description of the related technique Portable medical devices, such as auto-injectors, offer the benefit of providing therapy to patients away from a clinical setting and / or while worn discreetly under the patient's clothing. The portable medical device can be applied to the patient's skin and configured to automatically deliver a dose of a pharmaceutical composition within a predetermined timeframe. After the device releases the pharmaceutical composition, the patient can remove and dispose of the device. BRIEF DESCRIPTION OF THE INVENTION In one aspect or embodiment, a needle hub for a drug delivery device includes a needle holder and a needle attached to the needle holder, a needle drive assembly configured to move the needle holder from a retracted position to an insertion position and back to the retracted position, and a pressure interlock including an inlet configured to be in fluid communication with a fluid source, an outlet in fluid communication with the needle, and a locking element. The locking element has a first position where it prevents actuation of the needle drive assembly and a second position where it permits actuation of the needle drive assembly. The locking element moves from the first position to the second position depending on the pressure within the pressure interlock. The pressure interlock may include a cylinder, and the locking element may include a piston, with the inlet and outlet of the pressure interlock in fluid communication with the cylinder. The locking element may isolate the inlet from the outlet when the locking element is in the first position, while allowing fluid communication between the inlet and outlet when the locking element is in the second position. The pressure interlock may further include a vent configured to dissipate air from the cylinder. The vent may include a hydrophobic membrane. The needle cone may further include a tube connected to the outlet and in fluid communication with the needle. The locking element may include an opening where a portion of the needle drive assembly extends through the locking element opening when the locking element is in the second position. The needle drive assembly may include a cam track, a cam element, and a drive spring that presses the cam element against the cam track. A cam block may define the cam track, where the cam block extends through the locking element opening when the locking element is in the second position. The needle hub may include a skin expansion reduction mechanism with an adhesive surface designed to adhere to the skin. This mechanism is configured to stretch the skin at the point of needle penetration. The needle drive assembly may include a cannula, where the needle is received when the needle holder is in the retracted position. BRIEF DESCRIPTION OF THE DRAWINGS The aforementioned characteristics and other features and advantages of this disclosure, and the manner of achieving them, will be more evident and the disclosure itself better understood by reference to the following descriptions of the realizations taken together with the accompanying drawings. Figure 1 is a schematic view of a drug delivery device according to an aspect or embodiment of the present application. Figure 2 is a schematic view of the drug delivery device in Figure 1. Figure 3 is a perspective view of a needle cone according to an aspect or embodiment of the present application. Figure 4A is a top view of the needle cone in Figure 3, showing an indicator before use of the needle cone. franonn / eznz / E / YiAi Figure 4B is a top view of the needle cone in Figure 3, showing an indicator after needle insertion. Figure 4C is a top view of the needle cone in Figure 3, showing an indicator after cannula removal. Figure 5 is a schematic view showing one method of using the needle cone of Figure 3. Figure 6A is a schematic view of the needle cone in Figure 3, showing the actuation of an activation button. Figure 6B is a schematic view of the needle cone in Figure 3, showing the movement of a needle and cannula from a retracted position to an insertion position. Figure 6C is a schematic view of the needle cone of Figure 3, showing a needle in a retracted position and a cannula in an insertion position. Figure 6D is a schematic view of the needle cone in Figure 3, showing the movement of a cannula to a retracted position. Figure 7 is a perspective view of a needle cone according to an aspect or embodiment of the present application. Figure 8 is a front view of the needle cone from Figure 7, showing one infusion mode. Figure 9 is a front view of the needle cone from Figure 7, showing the removal of a cannula. Figure 10 is a perspective view of a needle cone according to an aspect or embodiment of the present application. Figure 11 is a schematic view showing one method of using the needle cone of Figure 7. Figure 12A is a schematic view of the needle cone in Figure 7, showing a pre-use position of the needle cone. Figure 12B is a schematic view of the needle cone of Figure 7, showing the needle cone being driven. Figure 12C is a schematic view of the needle cone of Figure 7, showing a needle being retracted. Figure 12D is a schematic view of the needle cone of Figure 7, showing a needle in a retracted position. Figure 12E is a schematic view of the needle cone of Figure 7, showing an applicator separating from the needle cone. Figure 12F is a schematic view of the needle cone of Figure 7, showing a cannula in a retracted position. Figure 13 is a cross-sectional view of a needle cone according to another aspect or embodiment of the present application. Figure 14 is a cross-sectional view of the needle cone of Figure 13. Figure 15 is a perspective view of a needle cone according to an aspect or embodiment of the present application. Figure 16 is a perspective view of a needle cone according to an aspect or embodiment of the present application. Figure 17 is a perspective view of a drive assembly according to an aspect or embodiment of the present application. Figure 18A is a cross-sectional view of the needle cone of Figure 15, showing one cannula insertion position. Figure 18B is a cross-sectional view of the needle cone of Figure 15, showing a retracted position of the cannula. Figure 19 is a perspective view of a needle cone according to another aspect or embodiment of the present application. Figure 20 is a schematic view showing one method of using the needle cone of Figure 19. Figure 21 is a perspective view of a needle drive assembly according to another aspect or embodiment of the present application. Figure 22 is a perspective view of a drug delivery device and needle cone according to another aspect or embodiment of the present application. Figure 23 is an exploded perspective view of the drug delivery device and needle cone from Figure 22. Figure 24 is a perspective view of the drug delivery device and needle cone from Figure 22, showing the drug delivery device and needle cone connected while a drug is being administered. Figure 25 is a perspective view of the drug delivery device and needle cone from Figure 22, showing the needle cone separated from the drug delivery device while a drug is being administered. Figure 26A is a cross-sectional view of a needle cone according to banonn / rznz / E / YiAi or any other aspect or embodiment of the present application, showing an initial position of the needle cone. Figure 26B is a cross-sectional view of a needle cone according to another aspect or embodiment of the present application, showing the coupling to a skin surface. Figure 26C is a cross-sectional view of a needle cone according to another aspect or embodiment of the present application, showing the insertion of a needle. Figure 27A is a cross-sectional view of a needle cone according to another aspect or embodiment of the present application, showing an initial position of the needle cone. Figure 27B is a cross-sectional view of a needle cone according to another aspect or embodiment of the present application, showing the coupling to a skin surface. Figure 27C is a cross-sectional view of a needle cone according to another aspect or embodiment of the present application, showing the insertion of a needle. Figure 28A is a cross-sectional view of a needle cone according to another aspect or embodiment of the present application, showing an initial position of the needle cone. Figure 28B is a cross-sectional view of a needle cone according to another aspect or embodiment of the present application, showing the coupling to a skin surface. Figure 28C is a cross-sectional view of a needle cone according to another aspect or embodiment of the present application, showing the insertion of a needle. Figure 29 is a perspective view of a needle drive assembly according to another aspect or embodiment of the present application, showing an undriven position. franonn / eznz / E / YiAi Figure 30 is a perspective view of the needle drive assembly of Figure 29, showing an actuated position. Figure 31 is the needle of Figure 29, which Figure 32 is the needle of Figure 29, which Figure 33 is a cross-sectional view showing an undriven position. A cross-sectional view shows an actuated position. A cross-sectional view of the needle drive assembly of Figure 29, showing a retracted position. Figure 34 is a perspective view of a needle cone according to an aspect or embodiment of the present application. Figure 35 is a schematic view of the needle cone of Figure 34. Figure 36 is a perspective view of a drug delivery device according to another aspect or embodiment of the present application. Figure 37 is a front view of the drug delivery device in Figure 36. Figure 38 is a front view of the drug delivery device in Figure 36, showing a separate reservoir from the drug delivery device. Figure 39 is a front view of the drug delivery device in Figure 36, showing the drug delivery device attached to a patient. Figure 40 is a partial cross-sectional view of a prior art valve assembly. Figure 41 is a front view of a cam lock of a needle drive assembly according to an aspect or embodiment of the present application. Figure 42 is a perspective view of a cam element of a needle drive assembly according to an aspect or embodiment of the present application. Figure 43 is a perspective view of a cannula holder of a needle drive assembly according to an aspect or embodiment of the present application. Figure 44 is a perspective view from above of the cannula holder in Figure 43, showing a cannula in an insertion position. Figure 45 is a perspective view from below of the cannula holder in Figure 43, showing a cannula in an insertion position. Figure 46 is a perspective view of a pressure interlock seal according to an aspect or embodiment of the present application. Figure 47 is a front view of a locking element of a pressure interlock according to an aspect or embodiment of the present application. Figure 48 is a perspective view of a pressure interlock for a needle drive assembly according to an aspect or embodiment of the present application. The corresponding reference characters indicate corresponding parts across several views. The illustrations defined herein illustrate examples of realizations of the disclosure, and such illustrations should not be interpreted in any way as limiting the scope of the disclosure. DETAILED DESCRIPTION OF THE INVENTION Spatial or directional terms, such as ''left, right, inside, outside, above, below, and the like,'' should not be considered limiting since the invention can assume several alternative orientations. All numbers used in the specification and claims should be understood to be modified in all cases by the term "approximately." "Approximately" means a range of plus or minus ten percent of the stated value. As used in the specification and claims, the singular forms "a" and "the" include plural references unless the context clearly indicates otherwise. The terms "first," "second," and the like are not intended to refer to any particular order or chronology, but rather to different conditions, properties, or elements. "At least" means greater than or equal to. With reference to Figures 1-3, a drug delivery device 10 includes a reservoir 12, a feed 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 portable auto-injector. The drug delivery device 10 can be mounted on a patient's skin and activated 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 it can be filled with the pharmaceutical composition by the patient or a healthcare professional prior to use. The control electronics 18 can include a processor 22, such as a microcontroller, a motor controller 23, a sensing module 24, a visual controller 25, and / or an audio controller 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 motorized, spring-driven, hydraulically actuated, pneumatically actuated and / or another suitable drive mechanism. The drug delivery device 10 is configured to deliver a dose of a pharmaceutical composition, for example, any desired medication, into the patient's body via subcutaneous injection at a controlled, slow injection rate. Example administration times achieved by the drug delivery device 10 can range from approximately 5 minutes to approximately 60 minutes, but are not limited to this range. Example volumes of the pharmaceutical composition delivered by the drug delivery device 10 can range from approximately 10 milliliters to approximately 50 milliliters, but are not limited to this range. The volume of the 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. With reference to Figures 3-6D, according to one aspect or embodiment, the insertion mechanism 16 includes a needle hub 30 separate from the housing 20. The needle hub 30 includes an extraction tab 32, an activation button 34, a status indicator 36, a digital grip, side grips, and an integrated cannula extraction tab 38. The needle hub 30 includes a permanent cannula. The status indicator 36 can be white when not in use (Figure 4A), blue when the needle has been inserted and is ready to infuse (Figure 4B), and green when the cannula has been withdrawn (Figure 4C). As shown in Figure 5, the needle cone 30 is used by removing the packaging, peeling off an adhesive coating from the bottom of the needle cone 30, attaching the needle cone 30 to a skin surface, and pressing the activation button 34, which causes the needle to retract automatically, leaving a permanent cannula in the patient.The medication or fluid is then infused into the patient. Once the infusion is complete, the cannula's retraction tab 38 is pulled, retracting the cannula. The needle hub 30 can then be withdrawn from the patient's skin. With reference to Figures 6A-6D, in one aspect or embodiment, the needle cone 30 includes a cone 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 cone body 42 and has a first actuating surface 56. The needle holder 44 is movable relative to the cone body 42 and has a second actuating surface 58. The first actuating surface 56 of the activation button 34 is configured to engage with the second actuating surface 58 of the needle holder 44. The needle spring 48 presses the needle holder 44 into a retracted position where the needle 46 is inserted. within the body of the cone 42. The cannula holder 50 can be moved in relation to the body of the cone 42 and the needle holder 44.The cannula 52 is configured to be in fluid communication with a fluid source, such as the fluid reservoir 12. The cannula spring 54 presses the cannula holder 50 into a retracted position where the cannula 52 is placed inside the cone body 42. The movement of the activation button 34 is configured to cause the first actuating surface 56 of the activation button 34 to engage with the second actuating surface 58 of the needle holder 44 to move the needle holder 44 and the cannula holder 50 from their respective retracted positions to the insertion positions where the distal ends of the needle 46 and the cannula 52 are placed outside the cone body 42, with the needle holder 44 configured to return to the retracted position while the cannula holder 50 remains in the insertion position.The movement of a part of the cone body 42 is configured to uncouple a connection between the cannula holder 50 and the cone body 42 to allow the cannula holder 50 to return to the retracted position. Referring again to Figures 6A-6D, the needle holder 44 includes a passage 60 configured to be in fluid communication with the fluid reservoir 12, with the needle 46 in fluid communication with passage 60 of the needle holder 44. At least a portion of the needle 46 is received into the cannula 52. The fluid is configured to flow from the fluid reservoir 12 through the tube 62 to passage 60 of the needle holder 44, through the needle 46, and into the cannula 52. The cannula holder 50 includes a seal 64 coupled to the needle 46. The needle cone 30 includes a first projection 66, and the cannula holder 50 includes a second projection 68, with the first projection 66 of the needle cone 66 engaging with the second projection 68 of the cannula holder 50 when the cannula 52 is in position. the insertion position to restrict the movement of the cannula holder 50 to the retracted position. With reference to Figures 3-6D, the needle cone 30 includes a retraction tab 70, where movement of the retraction tab 70 releases a coupling between the first projection 66 of the needle cone 30 and the second projection 68 of the cannula holder 50 to allow the cannula spring 54 to deflect the cannula 52 to the retracted position. At least a portion of the retraction tab 70 can be configured to engage with a person's skin surface after the needle cone 30 has been attached to a person. The trigger button 34 can be moved along a first axis 72, and the needle holder 44 and cannula holder 50 can be moved along a second axis 74 perpendicular to the first axis 72.The first drive surface 56 of the activation button 34 is set to disengage from the second drive surface 58 of the needle holder 44 after the movement of the activation button 34 is a predetermined distance along the first axis 72. With reference to Figures 7-14, a needle cone 80, according to another 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 cone body 92 having a cannula holder 94, a cannula 96 attached to the cannula holder 94, a cannula withdrawal button 98, and a cannula extraction spring 100. At least a portion of the cone body 92 is configured to be received within the applicator 82, and the applicator 82 is configured to be separated from the cone body 92.The movement of the activation button 90 is configured to move the needle holder 84 and cannula holder 94 from a retracted position, where the needle 86 and cannula 96 are placed inside the applicator 82 or cone body 92, to an insertion position, where the distal ends of the needle 86 and cannula 96 are placed outside the applicator 82 and cone body 92. The cannula withdrawal button 98 locks the cannula holder 94 in the insertion position against a pushing force from the cannula retraction spring 100 when the cannula holder 94 is moved from the retracted to the insertion position. As shown in Figure 10, in one aspect or embodiment, the cannula withdrawal button 98 may be omitted. With reference to Figures 12A-12F, the needle holder 84 is configured to move to the retracted position after the cannula holder 94 moves to the insertion position. The activation button 90 includes an extension 102 having an actuation projection 103, and the applicator 82 includes an actuation surface 104 configured to engage the actuation projection 103. Following movement of the activation button 90, the actuation projection 103 engages with the needle holder 84 to move the needle holder 84 and the cannula holder 94 to the insertion position, with the actuation projection 103 engaged with the actuation surface 104 of the applicator 82 to move the extension 102 radially outward, thereby releasing the needle holder 84 from the engagement projection 103 to allow the needle retraction spring 100 to return the needle holder 84 to the retracted position.The cannula withdrawal button 98 is configured to move the cannula holder 94 from the insertion position to the retracted position. The cone body 92 further includes an adhesive pad 105 configured to fix the cone body 92 to a person's skin surface. The adhesive pad 105 includes a retraction tab 106 extending radially outward from the cone body 92. The activation button 90 is received within an opening 107 defined by an applicator body 108 of the applicator 82. The cannula holder 94 includes a port 109 configured to be in fluid communication with the fluid reservoir 12, with the cannula 96 in fluid communication with the port 109. The tubing 110 is connected to the port of the cannula holder 94. With reference to Figure 11, in one aspect or embodiment, the needle cone 80 is used by removing the packaging, peeling off an adhesive coating, attaching the needle cone 80 to the patient's skin surface, removing a safety cap, and pressing the activation button 90 of the applicator 82, which automatically actuates and retracts the needle 86 to leave the permanent cannula 96. The applicator 82 can then be removed from the cone body 92, and the infusion can begin. Once the infusion is complete, the cannula removal button 98 can be pressed to remove the cannula 96 from the patient, and the cone body 92 is removed from the patient's skin using the extraction tab 106. With reference to Figures 13 and 14, in one aspect or embodiment, the cannula holder 94 includes a portion of the adhesive pad 105, which removes a portion of the adhesive pad 105 from the patient's skin when the cannula holder 94 is removed from the cone body 92 to facilitate the removal of the remainder of the adhesive pad 105 from the patient's skin. With reference to Figures 15-18B, a needle cone 112, according to another aspect or embodiment, includes a cone 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 drive mechanism 126, and a cannula spring 128. The needle drive mechanism 126 is configured to move the needle holder 118 and the cannula holder 122 from a retracted position to an insertion position and is configured to move the needle holder 118 back to the retracted position. The needle drive mechanism 126 includes a cam track 130, a cam element 132 received within the cam track 130, and a torsion spring 134. The torsion spring 134 presses the cam element 132 relative to the cam track 130. The cannula spring 128 presses the cannula holder 122 into a retracted position.The movement of the activation button 116 is configured to cause the needle holder 118 and the cannula holder 122 to move from the retracted position to the insertion position, with the needle holder 118 configured to return to the retracted position while the cannula holder 122 remains in the insertion position. As shown in Figure 16, in one aspect or embodiment, the needle cone 112 includes two side-activating push buttons 116. The needle cone 112 is used in the same manner as described above in relation to the needle cone 30 shown in Figure 5. With reference to Figures 17-18B, the cone body 114 includes a cannula lock 136 configured to lock the cannula holder 122 at the insertion point. The needle cone 112 includes an adhesive pad 138 configured to secure the cone body 114 to a person's skin surface, the adhesive pad 138 including a retraction tab 140. The movement of the retraction tab 140 is configured to disengage the cannula lock 136 and the cone body 114 to allow the cannula holder 122 to return to the retracted position. The cannula lock 136 is pressed from the cannula holder 122 via a locking spring 142, wherein the cone body 112 includes a hinged part 144, with the hinged part 144 configured to rotate with the movement of the extraction tab 140 and release from the cannula lock 136.The cannula holder 122 includes a port 146 configured to be in fluid communication with the fluid reservoir 12, with the cannula 124 in fluid communication with the port 146. The needle cone 112 includes a tube 148 connected to the port 146 of the cannula holder 122. The cannula holder 122 includes a seal 150 coupled to the needle 120, with at least a portion of the needle 120 received inside the cannula 124. With reference to Figures 19-21, a needle cone 152, according to another aspect or embodiment, includes a needle holder 154 and a needle 156 fixed to the needle holder 154, a needle drive assembly 158 configured to move the needle holder 154 from a retracted position to an insertion position and back to the retracted position, and a pressure-locking device 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 element 166. The locking element 166 has a first position in which the locking element 166 prevents the actuation of the needle drive assembly 158 and a second position in which the locking element 166 permits the actuation of the needle drive assembly 158.The locking element 166 moves from the first position to the second position depending on the pressure inside the pressure locking device 160. With reference to Figure 21, the locking element 166 isolates the inlet 162 from the outlet 164 when the locking element 166 is in the first position, and the locking element 166 allows free communication between the inlet 162 and the outlet 164 when the locking element 166 is in the second position. The needle cone 152 further includes a tube 168 connected to the outlet 164 and in free communication with the needle 156. The locking element 166 includes an opening 170, with a portion of the needle drive assembly 158 extending through the opening 170 of the locking element 166 when the locking element 166 is in the second position. The needle drive assembly 158 includes a cam track 172, a cam element 174, and a drive spring 176 that presses the cam element 174 against the cam track 172.A cam block 178 defines the cam track 172, the cam block 178 extending through the opening 170 of the locking element 166 when the locking element 166 is in the second position. The needle drive assembly 158 further includes a cannula 180, wherein the needle 156 is received within the cannula 180 when the needle holder 156 is in the retracted position. Referring again to Figures 19-21, the needle hub 152 includes a housing 182 and a withdrawal tab 184. The upper surface 186 of the housing 182 is smooth and has no activation buttons. As shown in Figure 20, the needle hub 152 is used by removing the packaging, peeling off an adhesive backing, attaching the needle hub 152 to a patient's skin surface, and activating the drive mechanism 27 to insert the needle 156. The needle 156 retracts automatically, leaving the permanent cannula 180. After the infusion is complete, the needle hub 152 is removed by grasping the withdrawal tab 184 and lifting it upward. The cannula 180 retracts automatically. In one aspect or embodiment, pulling the extraction tab 184 causes a drop in the pressure of the pressure lock 160 to cause the cannula holder and / or cannula 180 to retract automatically. With reference to Figures 22-25, a drug delivery device 190 and a needle cone 192 are shown, according to another aspect or embodiment. The drug delivery device 190 may be similar to the drug delivery device 10 shown in Figures 1 and 2. The drug delivery device 190 and needle cone 192 of Figures 22-25, however, are modular, with the needle cone 192 optionally integrated within the drug delivery device 190 (Figure 24) or with the needle cone 192 separate from the drug delivery device 190 and attached separately to a patient's skin surface (Figure 25). In one aspect or embodiment, the drug delivery device 190 and needle cone 192 may remain connected or integrated for lower drug volumes and separated with a fluid connection between them for larger drug volumes. With reference to Figures 26A-26C, a needle cone 200 with a skin expansion reduction function is shown, according to one aspect or embodiment. The needle cone 200 includes a rotating coupling mechanism 202, with a portion of the rotating coupling mechanism 202 initially contacting a patient's skin surface and adhering to it, rotating further as the needle cone 200 is fully pressed against the skin surface. The initial adhesion and subsequent rotation of the rotating coupling mechanism stretches the skin to reduce skin expansion. With reference to Figures 27A-27C, a needle cone 204 with a skin expansion reduction function is shown, according to one embodiment. The needle cone 204 includes an adhesive ring 206 that is pressed onto the skin prior to needle insertion when an activation button is pressed or actuated. The adhesive ring 206 stretches the skin to reduce skin expansion. With reference to Figures 28A-28C, a needle cone 208 with a skin expansion reduction function is shown, according to one embodiment. The needle cone 208 includes a skin stretching element 210 that moves radially outward after initially adhering to the skin surface of a patient. An activation button 212 engages with the skin stretching element 210 to move the skin stretching element 210 radially outward, which stretches the skin locally to reduce skin expansion. The skin expansion reduction features and associated mechanisms of Figures 26A-28C may be incorporated into any of the aspects or embodiments of the needle cone or needle insertion arrangements disclosed herein. With reference to Figures 29-33, a needle drive assembly 220, according to one aspect or embodiment, includes a clip 222 that holds a needle drive body 224 and a cannula body 226 in the retracted position, which are deflected by a spring 228. Pushing the clip 222 inward releases the needle drive body 224 and the cannula body 226 to cause the insertion of a needle 230 and a cannula 232. When the cannula body 226 reaches the bottom of a housing 233, the cannula body 226 comes into contact with angled features that cause the cannula body 226 to rotate and / or twist. The cannula body 226 is held by clips 236 to the walls of the housing 233. After the cannula body 226 is rotated and / or twisted, the needle actuator body 224 is released and a return spring 238 retracts the needle 230. With reference to Figures 34 and 35, a needle cone 240 according to another aspect or embodiment is configured to be decoupled from the remaining components of a drug delivery device. The needle cone 240 includes a protective cap 242, a needle insertion mechanism 244, a connection arrangement 246 configured to place the needle cone 240 in fluid communication with the reservoir 12 and the drive mechanism 27, a fluid path 248, and an adhesive pad and / or layer 250. The connection arrangement 246 can provide an aseptic connection between the needle cone 240 and the reservoir 12. Needle retraction can be triggered manually or automatically via an activation mechanism connected to an end-of-dose event and / or a wireless connection between the drive unit and the needle cone 240.The firing mechanism may include a rigid-flexible connection to the movement of the plunger rod (fully or partially at the end of the stroke). The fluid path 248 and the connection arrangement 246 are kept sterile until the connection is established, at which point the subsystem and reservoir are sterilized. With reference to Figures 36-39, a drug delivery device 252, according to another aspect or embodiment, includes a flexible reservoir 254, with at least a portion of the flexible reservoir 254 positioned externally from a remaining portion of the drug delivery device 252. The drug delivery device 252 may be similar to the drug delivery device 10 shown in Figures 1 and 2. As shown in Figure 39, for smaller volumes, such as 10-30 ml, the flexible reservoir 254 may be directly attached to the drug delivery device 252 and worn on the patient's skin surface. As shown in Figure 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 can be attached separately to the patient via a clip, harness, strap, or other suitable arrangement. With reference to Figure 40, drug delivery devices in any of the aspects or embodiments discussed above may utilize a valve assembly 260 that attaches to a reservoir and / or container to facilitate fluid connection between the reservoir and / or container and the fluid path to the needle and / or cannula. The valve assembly 260 may be similar to and function in the same manner as the valve assembly shown and described in U.S. Patent Application Publication No. 2017 / 0354788. With reference to Figures 41-48, a pressure interlock 270, according to another aspect or embodiment of the present application, is shown. The pressure interlock 270 is similar to and functions similarly to the pressure interlock 160 discussed above in relation to Figures 19-21. Similar part numbers are used for similar items. As shown in Figure 48, the pressure interlock 270 banonn / rznz / E / YiAi includes a cylinder 272 and the locking element 166 includes a piston 274, with the inlet 162 and outlet 164 of the pressure interlock 270 in fluid communication with the cylinder 272. The pressure interlock 270 includes a vent 276 configured to dissipate air from the cylinder 272. The vent 276 includes a hydrophobic membrane 278. In one aspect or embodiment, the hydrophobic membrane 278 has a burst pressure of 282 kPa (41 psi).In one aspect or embodiment, the vent 276 includes a one-way valve. The pressure interlock 270 includes a tube 280 connected to the outlet 164 and in fluid communication with the needle 156. As shown in Figure 41, in one aspect or embodiment, the cam track 172 of the cam block 178 is V-shaped to correspond to the downward movement of the needle 156 and its subsequent retraction. With reference to Figures 42 and 43, in one aspect or embodiment, the cam element 174 includes a base 282 having a pair of extensions 284 and a cylindrical projection 286 that is received within the cam track 172. In one aspect or embodiment, the cannula 180 is fixed to a cannula holder 288. With reference to Figures 44 and 45, in one aspect or embodiment, after the actuation of the needle 156 and the cannula 180, the cannula holder 288 is locked in an insertion position through one or more clips 290 provided on a base plate or housing 292 of a drug delivery device. With reference to Figures 46 and 47, in one aspect or embodiment, the locking element 166 includes a seal 294 that engages and forms a seal with the cylinder 272. The seal 294 may be a rubber plug or a butt gasket, although other suitable sealing arrangements may be used. The seal 294 is received by a mating portion of the seal 296 of the locking element 166. With reference to Figure 48, the pressure interlock 270 operates in the same way as the pressure interlock 160 in Figure 21. Before actuation, the locking element 166 is positioned next to the inlet 162 so that the inlet 162 is isolated from the outlet 164. The needle drive assembly 158 is prevented from actuating because the locking element 166 blocks or engages the cam block 178.When fluid is administered to inlet 162 through a drug delivery device, such as the drug delivery device 10 shown in Figures 1 and 2, the increased pressure within cylinder 272 causes the locking element 166 and seal 294 to move to the position shown in Figure 48 so that the opening 170 of the locking element 166 is aligned with the cam block 178 to allow the needle 156 and cannula 180 to be driven and also to place inlet 162 in fluid communication with outlet 164. As fluid is introduced into cylinder 272, air is expelled through vent 276. Although a cylindrical cylinder 272 is shown, other cylinders, such as a rounded rectangular cylinder or barrel 5, may be used appropriately. Although the invention has been described in detail for illustrative purposes based on what are currently considered the most practical and preferred embodiments, it is understood that such detail is for those purposes only and that the invention is not limited to the disclosed embodiments, but rather is intended to cover modifications and equivalent arrangements that are within the spirit and scope of the appended claims. For example, it is understood that the present invention contemplates the possibility of combining, to the extent possible, one or more features of any embodiment with one or more features of any other embodiment.

Claims

1. A needle hub for a drug delivery device comprising: a needle holder and a needle attached to the needle holder; a needle drive assembly configured to move the needle holder from a retracted position to an insertion position and back to the retracted position; and a pressure interlock comprising an inlet configured to be in fluid communication with a fluid source, an outlet in fluid communication with the needle, and a locking element, the locking element having a first position where the locking element prevents actuation of the needle drive assembly and a second position where the locking element permits actuation of the needle drive assembly, wherein the locking element moves from the first position to the second position depending on the pressure within the pressure interlock.

2. The needle cone of claim 1, wherein the pressure interlock comprises a cylinder and the locking element comprises a piston, the inlet and outlet of the pressure interlock being in fluid communication with the cylinder.

3. The needle cone of claim 1, wherein the locking element isolates the inlet from the outlet when the locking element is in the first position and wherein the locking element allows smooth communication between the inlet and the outlet when the locking element is in the second position.

4. The needle cone of claim 2, wherein the pressure lock further comprises a vent configured to dissipate air from the cylinder.

5. The needle cone of claim 4, wherein the ventilation comprises a hydrophobic membrane.

6. The needle cone of claim 2 further comprises a tube connected to and in fluid communication with the needle.

7. The needle cone of claim 1, wherein the locking element comprises an opening and wherein a portion of the needle drive assembly extends through the opening of the locking element when the locking element is in the second position.

8. The needle cone of claim 7, wherein the needle drive assembly comprises a cam track, a cam element, and a drive spring that presses the cam element against the cam track.

9. The needle cone of claim 8, wherein a cam block defines the cam track and wherein the cam block extends through the opening of the locking element when the locking element is in the second position.

10. The needle cone of claim 1, further comprising a skin expansion reduction mechanism 5 comprising an adhesive surface configured to adhere to the skin surface of a person, the skin expansion reduction mechanism configured to stretch the skin surface at a location where the needle penetrates the skin surface.

11. The needle cone of claim 1, wherein the needle drive assembly 10 further comprises a cannula and wherein the needle is received within the cannula when the needle holder is in the retracted position.

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