Hub for a drug delivery device with a pressure interlock

Abstract

A hub for a drug delivery device comprising: a needle holder and a needle attached to the needle holder; a needle actuation assembly configured to move the needle holder from a retracted position to an inserted 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 lock member. The lock member has a first position in which the lock member prevents actuation of the needle actuation assembly and a second position in which the lock member allows actuation of the needle actuation assembly. The lock member moves from the first position to the second position based on a pressure within the pressure interlock.

Description

[0001] Cross-reference to related applications

[0002] This application claims priority to U.S. Provisional Application No. 63 / 134,054, filed January 5, 2021, the entire disclosure of which is incorporated herein by reference. Technical Field

[0003] This disclosure relates to a needle hub for a drug delivery device. Background Technology

[0004] Wearable medical devices, such as auto-injection devices, offer the advantage of providing treatment to patients in locations remote from clinical facilities and / or when worn intermittently under the patient's clothing. The wearable medical device can be applied to the patient's skin and is configured to automatically deliver a dose of a drug composition over a predetermined period of time after application. After the device has delivered the drug composition to the patient, the patient can subsequently remove and discard the device. Summary of the Invention

[0005] In one aspect or embodiment, a needle holder for a drug delivery device includes: a needle holder and a needle attached to the needle holder; a needle actuation assembly configured to move the needle holder from a retracted position to an inserted position and back to the retracted position; and a pressure interlocking device including an inlet configured to be in fluid communication with a fluid source, an outlet configured to be in fluid communication with the needle, and a locking member. The locking member has a first position in which the locking member prevents actuation of the needle actuation assembly and a second position in which the locking member allows actuation of the needle actuation assembly. The locking member moves from the first position to the second position based on pressure within the pressure interlocking device.

[0006] The pressure interlock device may include a cylinder, and the locking member may include a piston, wherein the inlet and outlet of the pressure interlock device are in fluid communication with the cylinder. When the locking member is in a first position, it isolates the inlet from the outlet; when the locking member is in a second position, it allows fluid communication between the inlet and the outlet. The pressure interlock device may further include a vent configured to discharge air from the cylinder. The vent may include a hydrophobic membrane. The needle holder may also include a conduit connected to the outlet and in fluid communication with the needle.

[0007] The locking member may include an opening through which a portion of the pin actuation assembly extends when the locking member is in a second position. The pin actuation assembly may include a cam track, a cam member, and an actuation spring that biases the cam member relative to the cam track. A cam block may define the cam track, wherein the cam block extends through the opening in the locking member when the locking member is in the second position.

[0008] The needle hub may include a skin bulge reduction mechanism including an adhesive surface configured to adhere to a human skin surface, wherein the skin bulge reduction mechanism is configured to stretch the skin surface at the site where the needle penetrates the skin surface. The needle actuation assembly may further include a cannula, wherein the needle is received within the cannula when the needle holder is in the retracted position. Attached Figure Description

[0009] The above and other features and advantages of this disclosure, as well as the ways in which they are implemented, will become more apparent and the disclosure itself will be better understood by referring to the following description of embodiments of this disclosure taken in conjunction with the accompanying drawings, wherein:

[0010] Figure 1 This is a schematic diagram of a drug delivery device according to one aspect or embodiment of this application.

[0011] Figure 2 yes Figure 1 A schematic diagram of a drug delivery device.

[0012] Figure 3 This is a perspective view of a pin holder according to one aspect or embodiment of this application.

[0013] Figure 4A yes Figure 3 A top view of the needle holder, showing the indicator before using the needle holder.

[0014] Figure 4B yes Figure 3 A top view of the needle holder, showing the indicator after the needle is inserted.

[0015] Figure 4C yes Figure 3 A top view of the needle hub, showing the indicator after the cannula has been withdrawn.

[0016] Figure 5 It shows the use Figure 3 A schematic diagram of the needle seat method.

[0017] Figure 6A yes Figure 3 The schematic diagram of the needle holder shows the actuation of the activation button.

[0018] Figure 6B yes Figure 3 A schematic diagram of the needle hub shows the movement of the needle and cannula from the retracted position to the inserted position.

[0019] Figure 6C yes Figure 3 A schematic diagram of the needle hub shows the needle in the retracted position and the cannula in the inserted position.

[0020] Figure 6D yes Figure 3 A schematic diagram of the needle hub shows the movement of the sleeve to the retracted position.

[0021] Figure 7 This is a perspective view of the needle holder according to another aspect or embodiment of this application.

[0022] Figure 8 yes Figure 7 The front view of the needle hub shows the infusion pattern.

[0023] Figure 9 yes Figure 7 The front view of the needle hub shows the cannula retraction.

[0024] Figure 10 This is a perspective view of the needle holder according to another aspect or embodiment of this application.

[0025] Figure 11 It shows the use Figure 7 A schematic diagram of the needle seat method.

[0026] Figure 12A yes Figure 7 The diagram shows the needle holder in its pre-use position.

[0027] Figure 12B yes Figure 7 A schematic diagram of the needle hub, showing the needle hub being actuated.

[0028] Figure 12C yes Figure 7 A schematic diagram of the needle hub, showing the needle retracting.

[0029] Figure 12D yes Figure 7 A schematic diagram of the needle holder, showing the needle in the retracted position.

[0030] Figure 12E yes Figure 7 A schematic diagram of the needle hub, showing the applicator removed from the needle hub.

[0031] Figure 12F yes Figure 7 A schematic diagram of the needle hub shows the cannula in the retracted position.

[0032] Figure 13 This is a cross-sectional view of the needle holder according to another aspect or embodiment of this application.

[0033] Figure 14 yes Figure 13 A cross-sectional view of the needle holder.

[0034] Figure 15 This is a perspective view of the needle holder according to another aspect or embodiment of this application.

[0035] Figure 16 This is a perspective view of the needle holder according to another aspect or embodiment of this application.

[0036] Figure 17 This is a perspective view of a needle actuation component according to one aspect or embodiment of this application.

[0037] Figure 18A yes Figure 15 The cross-sectional view of the needle hub shows the insertion position of the sleeve.

[0038] Figure 18B yes Figure 15 The cross-sectional view of the needle hub shows the retracted position of the sleeve.

[0039] Figure 19 This is a perspective view of the needle holder according to another aspect or embodiment of this application.

[0040] Figure 20 It shows the use Figure 19 A schematic diagram of the needle seat method.

[0041] Figure 21 This is a perspective view of a needle actuation assembly according to another aspect or embodiment of this application.

[0042] Figure 22 This is a perspective view of a drug delivery device and needle hub according to another aspect or embodiment of this application.

[0043] Figure 23 yes Figure 22 An exploded perspective view of the drug delivery device and needle hub.

[0044] Figure 24 yes Figure 22 A perspective view of a drug delivery device and needle hub, showing the drug delivery device and needle hub connected during drug delivery.

[0045] Figure 25 yes Figure 22 A perspective view of the drug delivery device and needle hub, showing the needle hub separating from the drug delivery device during drug delivery.

[0046] Figure 26A This is a cross-sectional view of the needle holder according to another aspect or embodiment of this application, showing the initial position of the needle holder.

[0047] Figure 26B This is a cross-sectional view of the needle hub according to another aspect or embodiment of this application, showing its engagement with the skin surface.

[0048] Figure 26C This is a cross-sectional view of the needle holder according to another aspect or embodiment of this application, showing the insertion of the needle.

[0049] Figure 27A This is a cross-sectional view of the needle holder according to another aspect or embodiment of this application, showing the initial position of the needle holder.

[0050] Figure 27B This is a cross-sectional view of the needle hub according to another aspect or embodiment of this application, showing its engagement with the skin surface.

[0051] Figure 27C This is a cross-sectional view of the needle holder according to another aspect or embodiment of this application, showing the insertion of the needle.

[0052] Figure 28A This is a cross-sectional view of the needle holder according to another aspect or embodiment of this application, showing the initial position of the needle holder.

[0053] Figure 28B This is a cross-sectional view of the needle hub according to another aspect or embodiment of this application, showing its engagement with the skin surface.

[0054] Figure 28C This is a cross-sectional view of the needle holder according to another aspect or embodiment of this application, showing the insertion of the needle.

[0055] Figure 29 This is a perspective view of the needle actuation assembly according to another aspect or embodiment of this application, showing the unactuated position.

[0056] Figure 30 yes Figure 29 A perspective view of the needle actuation component, showing the actuation position.

[0057] Figure 31 yes Figure 29 A cross-sectional view of the needle actuator assembly, showing the unactuated position.

[0058] Figure 32 yes Figure 29 A cross-sectional view of the needle actuation assembly, showing the actuation position.

[0059] Figure 33 yes Figure 29 A cross-sectional view of the needle actuator assembly, showing the retracted position.

[0060] Figure 34 This is a perspective view of the needle holder according to another aspect or embodiment of this application.

[0061] Figure 35 yes Figure 34 A schematic diagram of the needle hub.

[0062] Figure 36 This is a perspective view of a drug delivery device according to another aspect or embodiment of this application.

[0063] Figure 37 yes Figure 36 Front view of a drug delivery device.

[0064] Figure 38 yes Figure 36 A front view of the drug delivery device, showing the reservoir separate from the drug delivery device.

[0065] Figure 39 yes Figure 36 A front view of the drug delivery device, showing the drug delivery device attached to the patient.

[0066] Figure 40 This is a partial cross-sectional view of a valve assembly in the prior art.

[0067] Figure 41 This is a front view of the cam block of a needle actuation assembly according to one aspect or embodiment of this application.

[0068] Figure 42 This is a perspective view of the cam member of a needle actuation assembly according to one aspect or embodiment of this application.

[0069] Figure 43 This is a perspective view of a sleeve retainer for a needle actuator assembly according to one aspect or embodiment of this application.

[0070] Figure 44 yes Figure 43 The top perspective view of the cannula retainer shows the cannula in the insertion position.

[0071] Figure 45 yes Figure 43 The bottom perspective view of the cannula retainer shows the cannula in the inserted position.

[0072] Figure 46 This is a perspective view of the seal of a pressure interlocking device according to one aspect or embodiment of this application.

[0073] Figure 47 This is a front view of the locking member of a pressure interlocking device according to one aspect or embodiment of this application.

[0074] Figure 48 This is a perspective view of a pressure interlock device for a needle actuator assembly according to one aspect or embodiment of this application.

[0075] Throughout multiple views, corresponding reference characters indicate the corresponding parts. The examples set forth herein illustrate exemplary embodiments of this disclosure, and such examples should not be construed as limiting the scope of this disclosure in any way. Detailed Implementation

[0076] Spatial or directional terms, such as “left,” “right,” “inner,” “outer,” “up,” “down,” etc., should not be considered limiting, as the invention can employ various alternative directions.

[0077] All figures used in the specification and claims should be understood to be modified by the term "about" in all cases. "About" means a range of ±10% of the stated value. As used in the specification and claims, the singular forms of "a" and "the" include plural referents unless the context clearly specifies otherwise. The terms "first," "second," etc., do not refer to any particular order or sequence, but rather to different conditions, properties, or elements. "At least" means "greater than or equal to."

[0078] Reference Figure 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 automated injection device. The drug delivery device 10 can be attached to a patient's skin and triggered to inject a drug composition from the reservoir 12 into the patient. The drug delivery device 10 can be pre-filled with a drug composition, or it can be filled by a patient or medical professional prior to use. The control electronics 18 may include a processor 22 (e.g., a microcontroller), a motor driver 23, a sensing module 24, a video 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 may be motor-driven, spring-driven, hydraulically driven, pneumatically driven, and / or other suitable drive mechanisms.

[0079] Drug delivery device 10 is configured to deliver a dose of a drug composition (e.g., any desired drug) to a patient via subcutaneous injection at a slow, controlled injection rate. Exemplary duration of delivery achieved by drug delivery device 10 may range from about 5 minutes to about 60 minutes, but is not limited to this exemplary range. Exemplary volume of the drug composition delivered by drug delivery device 10 may range from about 10 ml to about 50 ml, but is not limited to this exemplary range. The volume of the drug composition delivered to the patient can be adjusted. Drug delivery device 10 can communicate with another device such as a mobile device or a computer.

[0080] Reference Figure 3-6D According to one aspect or embodiment, the insertion mechanism 16 includes a needle holder 30 separate from the housing 20. The needle holder 30 includes a removal tab 32, an activation button 34, a status indicator 36, a finger grip, a side grip, and an integrated cannula retraction tab 38. The needle holder 30 includes an indwelling cannula. The status indicator 36 may be white when not in use. Figure 4A It can be blue when the needle is inserted and ready for infusion. Figure 4B ), while it can be green when the casing has been withdrawn. Figure 4C ).like Figure 5 As shown, 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 squeezing the activation button 34, which causes the needle to retract automatically, leaving an indwelling cannula in the patient's body. The medication or fluid is then infused into the patient. Once the infusion is complete, pulling the cannula retraction tab 38 retracts the cannula. The needle hub 30 can then be removed from the patient's skin.

[0081] Reference Figures 6A-6D In one aspect or embodiment, the needle holder 30 includes a holder body 42, an activation button 34, a needle holder 44, a needle 46 attached to the needle holder 44, a needle spring 48, a sleeve holder 50, a sleeve 52 attached to the sleeve holder 50, and a sleeve spring 54. The activation button 34 is movable relative to the holder body 42 and has a first actuation surface 56. The needle holder 44 is movable relative to the holder 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 toward a retracted position in which the needle 46 is located within the holder body 42. The sleeve holder 50 is movable relative to the holder body 42 and the needle holder 44. The sleeve 52 is configured to be in fluid communication with a fluid source (e.g., a fluid reservoir 12). A sleeve spring 54 biases the sleeve retainer 50 toward a retracted position, in which the sleeve 52 is located within the seat body 42. Movement of the activation button 34 is configured to cause a first actuating surface 56 of the activation button 34 to engage a second actuating surface 58 of the needle retainer 44, thereby moving the needle retainer 44 and the sleeve retainer 50 from their respective retracted positions to an insertion position, in which the distal ends of the needle 46 and the sleeve 52 are located outside the seat body 42, wherein the needle retainer 44 is configured to return to the retracted position while the sleeve retainer 50 remains in the insertion position. Movement of a portion of the seat body 42 is configured to disconnect the connection between the sleeve retainer 50 and the seat body 42, allowing the sleeve retainer 50 to return to the retracted position.

[0082] Refer again Figures 6A-6DThe needle retainer 44 includes a channel 60 configured to be in fluid communication with a fluid reservoir 12, wherein a needle 46 is in fluid communication with the channel 60 of the needle retainer 44. At least a portion of the needle 46 is received within a cannula 52. Fluid is configured to flow from the fluid reservoir 12 via the channel 62 to the channel 60 of the needle retainer 44, through the needle 46, and into the cannula 52. The cannula retainer 50 includes a seal 64 that engages with the needle 46. The needle seat 30 includes a first protrusion 66, and the cannula retainer 50 includes a second protrusion 68, wherein, when the cannula 52 is in the inserted position, the first protrusion 66 of the needle seat 66 engages the second protrusion 68 of the cannula retainer 50 to restrict movement of the cannula retainer 50 to a retracted position.

[0083] Reference Figure 3-6D The needle holder 30 includes a removal tab 70, wherein movement of the removal tab 70 releases engagement between a first protrusion 66 of the needle holder 30 and a second protrusion 68 of the cannula retainer 50, allowing the cannula spring 54 to bias the cannula 52 toward a retracted position. At least a portion of the removal tab 70 is configured to engage with the skin surface of a person after the needle holder 30 has been attached to the human body. An activation button 34 is movable along a first axis 72, and the needle retainer 44 and the cannula retainer 50 are movable along a second axis 74 perpendicular to the first axis 72. A first actuating surface 56 of the activation button 34 is configured to disengage from the second actuating surface 58 of the needle retainer 44 after the activation button 34 has been moved a predetermined distance along the first axis 72.

[0084] Reference Figure 7-14 According to another aspect or embodiment, the needle holder 80 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 seat body 92 having a cannula holder 94, a cannula 96 attached to the cannula holder 94, a cannula retraction button 98, and a cannula retraction spring 100. At least a portion of the seat body 92 is configured to be received within the applicator 82, and the applicator 82 is configured to be separable from the seat body 92. Movement of the activation button 90 is configured to move the needle holder 84 and the cannula holder 94 from a retracted position to an inserted position, in which the needle 86 and the cannula 96 are located within the applicator 82 or the seat body 92, and in the inserted position, the distal ends of the needle 86 and the cannula 96 are located outside the applicator 82 and the seat body 92. As the cannula retainer 94 moves from the retracted position to the inserted position, the cannula retraction button 98 overcomes the biasing force of the cannula retraction spring 100 and locks the cannula retainer 94 in the inserted position. Figure 10 As shown, in one aspect or embodiment, the sleeve retraction button 98 may be omitted.

[0085] Reference Figure 12A-12FThe needle holder 84 is configured to move to a retracted position after the cannula holder 94 has been moved to the insertion position. The activation button 90 includes an extension 102 having an actuation protrusion 103, and the applicator 82 includes a drive surface 104 configured to engage the drive protrusion 103. When the activation button 90 is activated, the drive protrusion 103 engages the needle holder 84 to move the needle holder 84 and the cannula holder 94 to the insertion position, wherein the drive protrusion 103 engages the drive surface 104 of the applicator 82 to move the extension 102 radially outward, thereby releasing the needle holder 84 from the drive protrusion 103 to allow the needle retraction spring 100 to return the needle holder 84 to the retracted position. Actuation of the cannula retraction button 98 is configured to move the cannula holder 94 from the insertion position to the retracted position. The seat body 92 also includes an adhesive pad 105 configured to secure the seat body 92 to the surface of a person's skin. The adhesive pad 105 includes a removal tab 106 extending radially outward from the seat body 92. An activation button 90 is received within an opening 107 defined by the body 108 of the applicator 82. The sleeve retainer 94 includes a port 109 configured to be in fluid communication with the fluid reservoir 12, wherein the sleeve 96 is in fluid communication with the port 109. A conduit 110 is connected to the port of the sleeve retainer 94.

[0086] Reference Figure 11 In one aspect or embodiment, the use of the needle hub 80 is performed by: removing the packaging, removing the adhesive liner, attaching the needle hub 80 to the patient's skin surface and removing the safety cap, and pressing the activation button 90 of the applicator 82, which automatically actuates and retracts the needle 86 to leave the indwelling cannula 96. The applicator 82 can then be removed from the hub body 92, and infusion can begin. Once infusion is complete, the cannula retraction button 98 can be pressed to remove the cannula 96 from the patient, wherein the hub body 92 is removed from the patient's skin using the removal tab 106.

[0087] Reference Figure 13 and Figure 14 In one aspect or embodiment, the cannula retainer 94 includes a portion of an adhesive pad 105 that is removed from the patient's skin when the cannula retainer 94 is removed from the seat body 92, so as to facilitate easier removal of the remaining portion of the adhesive pad 105 from the patient's skin.

[0088] Reference Figure 15-18BAccording to another aspect or embodiment, the needle holder 112 includes a holder 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 a retracted position to an inserted position, and is configured to move the needle holder 118 back 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 134. The torsion spring 134 biases the cam member 132 relative to the cam track 130. The cannula spring 128 biases the cannula holder 122 toward the retracted position. The activation button 116 is configured to move the needle retainer 118 and the cannula retainer 122 from the retracted position to the inserted position, wherein the needle retainer 118 is configured to return to the retracted position while the cannula retainer 122 remains in the inserted position. Figure 16 As shown, in one aspect or embodiment, the needle holder 112 includes two lateral squeeze-activated buttons 116. The needle holder 112 is used in conjunction with the above. Figure 5 The needle holder 30 shown is used in the same manner as described.

[0089] Reference Figure 17-18B The seat body 114 includes a cannula lock 136 configured to lock the cannula retainer 122 in the insertion portion. The needle holder 112 includes an adhesive pad 138 configured to secure the seat body 114 to the surface of human skin, wherein the adhesive pad 138 includes a removal tab 140. Movement of the removal tab 140 is configured to disengage the cannula lock 136 from the seat body 114 to allow the cannula retainer 122 to return to a retracted position. The cannula lock 136 is biased away from the cannula retainer 122 via a locking spring 142, wherein the seat body 112 includes a hinge portion 144 configured to rotate and disengage from the cannula lock 136 during movement of the removal tab 140. The cannula retainer 122 includes a port 146 configured to fluidly communicate with a fluid reservoir 12, wherein the cannula 124 is in fluid communication with the port 146. The needle holder 112 includes a conduit 148 connected to a port 146 of the sleeve retainer 122. The sleeve retainer 122 includes a seal 150 that engages with the needle 120, wherein at least a portion of the needle 120 is received within the sleeve 124.

[0090] Reference Figure 19-21According to another aspect or embodiment, the needle holder 152 includes: a needle retainer 154 and a needle 156 attached to the needle retainer 154; a needle actuation assembly 158 configured to move the needle retainer 154 from a retracted position to an inserted position and return it to the retracted position; and a pressure interlocking device 160 including an inlet 162 configured to be in fluid communication with a fluid reservoir 12, an outlet 164 configured to be in fluid communication with the needle 156, and a locking member 166. The locking member 166 has a first position and a second position, in which the locking member 166 prevents the needle actuation assembly 158 from being actuated, and in the second position, the locking member 166 allows the needle actuation assembly 158 to be actuated. The locking member 166 moves from the first position to the second position based on pressure within the pressure interlocking device 160.

[0091] Reference Figure 21 When the locking member 166 is in a first position, it isolates the inlet 162 from the outlet 164. When the locking member 166 is in a second position, it allows fluid communication between the inlet 162 and the outlet 164. The needle holder 152 also includes a conduit 168 connected to the outlet 164 and in fluid communication with the needle 156. The locking member 166 includes an opening 170, wherein, when the locking member 166 is in the second position, a portion of the needle actuation assembly 158 extends through the opening 170 of the locking member 166. The needle actuation assembly 158 includes a cam track 172, a cam member 174, and an actuation spring 176 that biases the cam member 174 relative to the cam track 172. A cam block 178 defines the cam track 172, wherein, when the locking member 166 is in the second position, the cam block 178 extends through the opening 170 of the locking member 166. The needle actuation assembly 158 also includes a sleeve 180, wherein the needle 156 is received within the sleeve 180 when the needle holder 156 is in the retracted position.

[0092] Refer again Figure 19-21 The pin holder 152 includes a housing 182 and a removal tab 184. The top surface 186 of the housing 182 is smooth and has no activation button. Figure 20 As shown, the needle hub 152 is used by removing the packaging, removing the adhesive liner, attaching the needle hub 152 to the patient's skin surface, and activating the drive mechanism 27 to insert the needle 156, which automatically retracts, leaving the indwelling cannula 180. After infusion, the needle hub 152 is removed by grasping and lifting the removal tab 184, with the cannula 180 automatically retracting. In one aspect or embodiment, pulling the removal tab 184 causes a pressure drop in the pressure interlock device 160, thereby causing the cannula retainer and / or the cannula 180 to automatically retract.

[0093] Reference Figure 22-25The image shows a drug delivery device 190 and a needle hub 192 according to another aspect or embodiment. The drug delivery device 190 may be similar to... Figure 1 and Figure 2 The drug delivery device 10 shown. However, Figure 22-25 The drug delivery device 190 and needle hub 192 are modular, wherein the needle hub 192 is optionally integrated within the drug delivery device 190. Figure 24 Alternatively, the needle hub 192 may be detached from the drug delivery device 190 and attached separately to the patient's skin surface. Figure 25 In one aspect or embodiment, the drug delivery device 190 and the needle hub 192 may remain connected or integrated for use with lower drug volumes, and may be separated from the fluid connection between them for use with larger drug volumes.

[0094] Reference Figures 26A-26C The image illustrates a needle hub 200 with skin bulge reduction features according to one aspect or embodiment. The needle hub 200 includes a rotary engagement mechanism 202, a portion of which initially contacts and adheres to the patient's skin surface, and further rotates as the needle hub 200 is fully pressed against the skin surface. The initial adhesion and further rotation of the rotary engagement mechanism stretch the skin to reduce skin bulge.

[0095] Reference Figures 27A-27C The image illustrates a needle holder 204 with skin bulge reduction features according to one aspect or embodiment. The needle holder 204 includes an adhesive ring 206 that is pressed against the skin before needle insertion when an activation button is pressed or actuated. The adhesive ring 206 stretches the skin to reduce skin bulge.

[0096] Reference Figures 28A-28C The image illustrates a needle holder 208 with skin bulge reduction features according to one aspect or embodiment. The needle holder 208 includes a skin stretching member 210 that moves radially outward after initial adhesion to the patient's skin surface. Activating a button 212 engages the skin stretching member 210 to move it radially outward, which locally stretches the skin to reduce skin bulge.

[0097] Figure 26A-28C The skin bulge reduction features and associated mechanisms can be incorporated into any aspect or embodiment of the needle hub or needle insertion device disclosed herein.

[0098] Reference Figures 29-33According to one aspect or embodiment, the needle actuation assembly 220 includes a clamp 222 that holds a needle actuation body 224 and a cannula body 226 in a retracted position, the needle actuation body and the cannula body being biased by a spring 228. Pushing the clamp 222 inward releases the needle actuation body 224 and the cannula body 226 to induce insertion of the needle 230 and the cannula 232. When the cannula body 226 reaches the bottom of the housing 233, the cannula body 226 contacts at an angle, causing the cannula body 226 to rotate and / or twist. The cannula body 226 is held downward by a clamp 236 in the wall of the housing 233. After the cannula body 226 has rotated and / or twisted, the needle actuation body 224 is released, and the return spring 238 retracts the needle 230.

[0099] Reference Figure 34 and Figure 35 According to another aspect or embodiment, the needle hub 240 is configured to be disconnected from the rest of the drug delivery device. The needle hub 240 includes a protective cap 242, a needle insertion mechanism 244, a connection device 246, a fluid path 248, and an adhesive pad and / or layer 250. The connection device is configured to provide fluid communication between the needle hub 240 and the reservoir 12. The connection device 246 provides a sterile connection between the needle hub 240 and the reservoir 12. Needle retraction can be manually activated or automatically activated via a trigger mechanism associated with 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 movement of the plunger rod (completely or partially at the end of translation). The fluid path 248 and the connection device 246 are kept sterile until connection is established by sterilizing the subsystem and the reservoir.

[0100] Reference Figures 36-39 According to another aspect or embodiment, the drug delivery device 252 includes a flexible reservoir 254, wherein at least a portion of the flexible reservoir 254 is located outside the remainder of the drug delivery device 252. The drug delivery device 252 may be similar to... Figure 1 and Figure 2 The drug delivery device 10 shown is illustrated. Figure 39 As shown, for smaller volumes, such as 10 mL to 30 mL, the flexible reservoir 254 can be directly attached to the drug delivery device 252 and worn on the patient's skin. Figure 38 As shown, for larger volumes, such as 50 mL, the flexible reservoir 254 can be detached from the drug delivery device 252 and fluidly connected to the drug delivery device 252 via a fluid path 256 (e.g., a tube). The flexible reservoir 254 can be individually attached to the patient via a clip, strap, band, or other suitable device.

[0101] Reference Figure 40The drug delivery device in any of the foregoing aspects or embodiments may utilize valve assembly 260, which engages a reservoir and / or container to facilitate fluid connection between the reservoir and / or container and a fluid path to the needle and / or cannula. Valve assembly 260 may be similar to and operate in the same manner as the valve assembly shown and described in U.S. Patent Application Publication No. 2017 / 0354788.

[0102] Reference Figures 41-48 This illustrates a pressure interlock device 270 according to another aspect or embodiment of the present application. This pressure interlock device 270 is similar to the one described above. Figure 19-21 The pressure interlock device 160 discussed here has a similar function. Similar reference numerals are used for similar elements. Figure 48 As shown, the pressure interlock device 270 includes a cylinder 272 and a locking member 166 including a piston 274, wherein both the inlet 162 and the outlet 164 of the pressure interlock device 270 are in fluid communication with the cylinder 272. The pressure interlock device 270 includes an exhaust port 276 configured to discharge air from the cylinder 272. The exhaust port 276 includes a hydrophobic membrane 278. In one aspect or embodiment, the hydrophobic membrane 278 has a penetration pressure of 41 psi. In one aspect or embodiment, the exhaust port 276 includes a one-way valve. The pressure interlock device 270 includes a conduit 280 connected to the outlet 164 and in fluid communication with a needle 156. Figure 41 As shown, 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 the subsequent retraction of the needle 156.

[0103] Reference Figure 42 and Figure 43 In one aspect or embodiment, the cam member 174 includes a base 282 having a pair of extensions 284 and a cylindrical protrusion 286 received within the cam track 172. In one aspect or embodiment, the sleeve 180 is attached to a sleeve retainer 288.

[0104] Reference Figure 44 and Figure 45 In one aspect or embodiment, after the actuation needle 156 and the cannula 180, the cannula retainer 288 is locked in the insertion position by one or more clips 290 disposed on the base plate or housing 292 of the drug delivery device.

[0105] Reference Figure 46 and Figure 47In one aspect or embodiment, the locking member 166 includes a seal 294 that engages with the cylinder body 272 to form a seal. The seal 294 may be a rubber plug or an O-ring, but other suitable sealing devices may also be used. The seal 294 is received by a sealing engagement portion 296 of the locking member 166.

[0106] Reference Figure 48 Pressure interlock device 270 with Figure 21 The pressure interlock device 160 operates in the same manner. Before actuation, the locking member 166 is positioned adjacent to the inlet 162, isolating the inlet 162 from the outlet 164. The needle actuation assembly 158 is prevented from actuating because the locking member 166 blocks or engages the cam block 178. When fluid passes through a drug delivery device (e.g., such as...), Figure 1 and Figure 2 When the drug delivery device 10 shown is delivered to the inlet 162, the increased pressure inside the cylinder 272 causes the locking member 166 and the seal 294 to... Figure 48 The positional shift shown aligns the opening 170 of the locking member 166 with the cam block 178 to allow actuation of the needle 156 and the sleeve 180, and to establish fluid communication between the inlet 162 and the outlet 164. As fluid is introduced into the cylinder 272, air is dissipated through the exhaust port 276. Although a cylindrical cylinder 272 is shown, other suitable cylinder shapes may be used, such as rounded rectangular cylinders or barrels.

[0107] Although the invention has been described in detail based on embodiments currently considered to be most practical and preferred for illustrative purposes, it should be understood that such details are for illustrative purposes only, and the invention is not limited to the disclosed embodiments, but is instead intended to cover modifications and equivalent arrangements falling within the spirit and scope of the appended claims. For example, it should be understood that the invention contemplates that, to the extent possible, one or more features of any embodiment may be combined with one or more features of any other embodiment.

Claims

1. A needle hub for a drug delivery device, comprising: Needle holder and needle attached to the needle holder; A needle actuation assembly configured to move the needle holder from a retracted position to an inserted position and back to the retracted position; and A pressure interlock device includes an inlet configured to be in fluid communication with a fluid source, an outlet configured to be in fluid communication with a needle, and a locking member having a first position and a second position, wherein in the first position the locking member prevents the needle actuation assembly from being actuated, and in the second position the locking member allows the needle actuation assembly to be actuated, wherein the locking member moves from the first position to the second position based on pressure within the pressure interlock device.

2. The needle holder according to claim 1, wherein, The pressure interlock device includes a cylinder, and the locking member includes a piston. The inlet and outlet of the pressure interlock device are in fluid communication with the cylinder.

3. The needle holder according to claim 1, wherein, When the locking member is in the first position, the locking member isolates the inlet from the outlet, and wherein, when the locking member is in the second position, the locking member allows fluid communication between the inlet and the outlet.

4. The needle holder according to claim 2, wherein, The pressure interlock device also includes an exhaust port configured to discharge air from the cylinder.

5. The needle hub according to claim 4, wherein the vent includes a hydrophobic membrane.

6. The needle holder according to claim 2, further comprising a conduit connected to the outlet and in fluid communication with the needle.

7. The needle holder according to claim 1, wherein, The locking member includes an opening, and wherein, when the locking member is in the second position, a portion of the needle actuation assembly extends through the opening of the locking member.

8. The needle holder according to claim 7, wherein, The needle actuation assembly includes a cam track, a cam member, and an actuation spring, wherein the actuation spring biases the cam member relative to the cam track.

9. The needle holder according to claim 8, wherein, The cam block defines the cam track, and wherein, when the locking member is in the second position, the cam block extends through the opening of the locking member.

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

11. The needle holder according to claim 1, wherein, The needle actuation assembly further includes a sleeve, wherein the needle is received within the sleeve when the needle holder is in the retracted position.

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