Needle hub with pressure interlock for drug delivery devices

Abstract

A needle hub 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 insertion position and back to the retracted position, an inlet configured to be in fluid communication with a fluid source, an outlet in fluid communication with the needle, and a pressure interlock including 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 is moved from the first position to the second position based on pressure in the pressure interlock.

Description

Technical Field

[0001] The present disclosure relates to a needle hub for a drug delivery device.

Background Art

[0002] Cross-reference to Related Applications This application claims priority to U.S. Provisional Application No. 63 / 134,054, filed on January 5, 2021, which is hereby incorporated by reference in its entirety.

[0003] Wearable medical devices, such as autoinjectors, have the advantage of providing treatment to patients while they are located far from a clinical facility and / or while individually worn under a patient's clothing. A wearable medical device can be applied to a patient's skin and configured to automatically deliver a dose of a pharmaceutical composition within a predetermined period after the wearable medical device is applied to the patient's skin. After the device administers the pharmaceutical composition to the patient, the patient can subsequently remove and discard the device.

Prior Art Documents

Patent Documents

[0004]

Patent Document 1

Summary of the Invention

[0005] In one embodiment or aspect, a needle hub for a drug delivery device includes a needle holder and a needle mounted in 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 including an inlet configured to communicate fluidly with a fluid source, an outlet communicating fluidly with the needle, and a locking member. The locking member has a first position in which the locking member prevents the needle actuation assembly from acting, and a second position in which the locking member allows the needle actuation assembly to act. The locking member is moved from the first position to the second position based on the pressure in the pressure interlock.

[0006] The pressure interlock may include a cylinder, and the locking member may include a piston through which the inlet and outlet of the pressure interlock are in fluid communication with the cylinder. The locking member can isolate the inlet from the outlet when the locking member is in a first position, and the locking member can enable fluid communication between the inlet and outlet when the locking member is in a second position. The pressure interlock may further include an exhaust port configured to discharge air from the cylinder. The exhaust port may include a hydrophobic membrane. The needle hub may further include a tube connected to the outlet and in fluid communication with the needle.

[0007] The locking member may include an opening, and a portion of the needle actuation assembly extends through the opening in the locking member when the locking member is in a second position. The needle 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, and the cam block extends through the opening in the locking member when the locking member is in a second position.

[0008] The needle hub may include a skin tenting reduction mechanism, which includes an adhesive surface configured to adhere to the surface of human skin, and the skin tenting reduction mechanism is configured to stretch the skin surface at the point where the needle penetrates the skin surface. The needle acting assembly may further include a cannula into which the needle is received when the needle holder is in the retracted position. [Brief explanation of the drawing]

[0009] The features and other advantages of this disclosure, as well as the methods for achieving them, will become clearer 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. [Figure 1] Figure 1 is a schematic diagram of a drug delivery device according to one aspect or embodiment of this application. [Figure 2] Figure 2 is a schematic diagram of the drug delivery device shown in Figure 1. [Figure 3] Figure 3 is a perspective view of a needle hub according to one aspect or embodiment of the present application. [Figure 4A] Figure 4A is a top view of the needle hub in Figure 3, showing the indicator before use of the needle hub. [Figure 4B] Figure 4B is a top view of the needle hub in Figure 3, showing the indicator after needle insertion. [Figure 4C] Figure 4C is a top view of the needle hub in Figure 3, showing the indicator after cannula withdrawal. [Figure 5] Figure 5 is a schematic diagram showing how to use the needle hub shown in Figure 3. [Figure 6A] Figure 6A is a schematic diagram of the needle hub shown in Figure 3, illustrating the operation of the power button. [Figure 6B] Figure 6B is a schematic diagram of the needle hub in Figure 3, showing the movement of the needle and cannula from the storage position to the insertion position. [Figure 6C] Figure 6C is a schematic diagram of the needle hub in Figure 3, showing the needle in the stowed position and the cannula in the insertion position. [Figure 6D] Figure 6D is a schematic diagram of the needle hub in Figure 3, showing the movement of the cannula to its storage position. [Figure 7] Figure 7 is a perspective view of a needle hub according to a further aspect or embodiment of the present application. [Figure 8] Figure 8 is a front view of the needle hub in Figure 7, showing the injection mode. [Figure 9]Figure 9 is a front view of the needle hub of FIG. 7 showing the withdrawal of the cannula. [Figure 10] Figure 10 is a perspective view of a needle hub according to a further aspect or embodiment of the present application. [Figure 11] Figure 11 is a schematic view showing a method of using the needle hub of FIG. 7. [Figure 12A] Figure 12A is a schematic view of the needle hub of FIG. 7 showing the pre-use position of the needle hub. [Figure 12B] Figure 12B is a schematic view of the needle hub of FIG. 7 showing the actuated needle hub. [Figure 12C] Figure 12C is a schematic view of the needle hub of FIG. 7 showing the stored needle. [Figure 12D] Figure 12D is a schematic view of the needle hub of FIG. 7 showing the needle in the storage position. [Figure 12E] Figure 12E is a schematic view of the needle hub of FIG. 7 showing the applicator removed from the needle hub. [Figure 12F] Figure 12F is a schematic view of the needle hub of FIG. 7 showing the cannula in the storage position. [Figure 13] Figure 13 is a cross-sectional view of a needle hub according to a further aspect or embodiment of the present application. [Figure 14] Figure 14 is a cross-sectional view of the needle hub of FIG. 13. [Figure 15] Figure  15 is a perspective view of a needle hub according to a further aspect or embodiment of the present application. [Figure 16] Figure 16 is a perspective view of a needle hub according to a further aspect or embodiment of the present application. [Figure 17] Figure 17 is a perspective view of a needle actuation assembly according to an aspect or embodiment of the present application. [Figure 18A] Figure 18A is a cross-sectional view of the needle hub of FIG. 15 showing the cannula insertion position. [Figure 18B] Figure 18B is a cross-sectional view of the needle hub of FIG. 15 showing the cannula storage position. [Figure 19] Figure 19 is a perspective view of a needle hub according to a further aspect or embodiment of the present application. [Figure 20] Figure 20 is a schematic diagram showing how to use the needle hub shown in Figure 19. [Figure 21] Figure 21 is a perspective view of a needle actuation assembly according to a further aspect or embodiment of the present application. [Figure 22] Figure 22 is a perspective view of a drug delivery device and needle hub according to a further aspect or embodiment of the present application. [Figure 23] Figure 23 is an exploded perspective view of the drug delivery device and needle hub shown in Figure 22. [Figure 24] Figure 24 is a perspective view of the drug delivery device and needle hub from Figure 22, showing the drug delivery device and needle hub connected while the drug is being delivered. [Figure 25] Figure 25 is a perspective view of the drug delivery device and needle hub from Figure 22, showing the needle hub separated from the drug delivery device during drug delivery. [Figure 26A] Figure 26A is a cross-sectional view of a needle hub according to a further aspect or embodiment of this application, showing the initial position of the needle hub. [Figure 26B] Figure 26B is a cross-sectional view of a needle hub according to a further aspect or embodiment of this application, showing engagement with a skin surface. [Figure 26C] Figure 26C is a cross-sectional view of a needle hub according to a further aspect or embodiment of this application, showing needle insertion. [Figure 27A] Figure 27A is a cross-sectional view of a needle hub according to a further aspect or embodiment of this application, showing the initial position of the needle hub. [Figure 27B] Figure 27B is a cross-sectional view of a needle hub according to a further aspect or embodiment of this application, showing engagement with a skin surface. [Figure 27C] Figure 27C is a cross-sectional view of a needle hub according to a further aspect or embodiment of this application, showing needle insertion. [Figure 28A] Figure 28A is a cross-sectional view of a needle hub according to a further aspect or embodiment of this application, showing the initial position of the needle hub. [Figure 28B]Figure 28B is a cross-sectional view of a needle hub according to a further aspect or embodiment of this application, showing engagement with a skin surface. [Figure 28C] Figure 28C is a cross-sectional view of a needle hub according to a further aspect or embodiment of this application, showing needle insertion. [Figure 29] Figure 29 is a perspective view of a needle actuation assembly according to a further aspect or embodiment of this application, showing the non-actuated position. [Figure 30] Figure 30 is a perspective view of the needle operating assembly shown in Figure 29, indicating the operating position. [Figure 31] Figure 31 is a cross-sectional view of the needle actuation assembly shown in Figure 29, indicating the non-acting position. [Figure 32] Figure 32 is a cross-sectional view of the needle actuation assembly shown in Figure 29, indicating the operating position. [Figure 33] Figure 33 is a cross-sectional view of the needle actuation assembly shown in Figure 29, indicating its storage position. [Figure 34] Figure 34 is a perspective view of a needle hub according to a further aspect or embodiment of the present application. [Figure 35] Figure 35 is a schematic diagram of the needle hub shown in Figure 34. [Figure 36] Figure 36 is a perspective view of a drug delivery device according to a further aspect or embodiment of the present application. [Figure 37] Figure 37 is a front view of the drug delivery device shown in Figure 36. [Figure 38] Figure 38 is a front view of the drug delivery device shown in Figure 36, showing the reservoir separated from the drug delivery device. [Figure 39] Figure 39 is a front view of the drug delivery device shown in Figure 36, illustrating the drug delivery device attached to the patient. [Figure 40] Figure 40 is a partial cross-sectional view of a conventional valve assembly. [Figure 41] Figure 41 is a front view of a cam block of a needle actuation assembly according to one aspect or embodiment of the present application. [Figure 42] Figure 42 is a perspective view of a cam member of a needle actuation assembly according to one aspect or embodiment of the present application. [Figure 43] Figure 43 is a perspective view of a cannula holder of a needle-operated assembly according to one aspect or embodiment of the present application. [Figure 44] Figure 44 is a top perspective view of the cannula holder shown in Figure 43, indicating the cannula in the insertion position. [Figure 45] Figure 45 is a bottom perspective view of the cannula holder shown in Figure 43, showing the cannula in the insertion position. [Figure 46] Figure 46 is a perspective view of a pressure interlock seal according to one aspect or embodiment of the present application. [Figure 47] Figure 47 is a front view of a locking member of a pressure interlock according to one aspect or embodiment of the present application. [Figure 48] Figure 48 is a perspective view of a pressure interlock for a needle actuation assembly according to one aspect or embodiment of the present application.

[0010] Corresponding reference numerals indicate corresponding parts through some of the figures. The examples presented herein illustrate exemplary embodiments of the disclosure, and such examples should not be construed as limiting the scope of the disclosure in any way. [Modes for carrying out the invention]

[0011] Spatial or directional terms such as "left," "right," "inner," "outer," "above," and "below" should not be considered limiting, as the present invention may envision a variety of alternative orientations.

[0012] All figures used herein and in the claims should be understood to be modified in all examples by the term “about.” “About” means a range of plus or minus 10 percent of the stated value. Where used herein and in the claims, the singular forms “a,” “an,” and “the” refer to multiple subjects unless the context clearly indicates otherwise. The terms “first,” “second,” etc., are not intended to refer to any particular order or chronology, but rather to different conditions, characteristics, or elements. “At least” means “greater than or equal to.”

[0013] Referring to Figures 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 may be attached to the patient's skin and may operate to inject a pharmaceutical composition into the patient from the reservoir 12. The drug delivery device 10 may be pre-filled with a pharmaceutical composition, or the drug delivery device 10 may be filled with a pharmaceutical composition by the patient or healthcare professional before use. The control electronics 18 may 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 distribute fluid from the reservoir 12. The drive mechanism 27 may be motor-driven, spring-driven, hydraulic-driven, pneumatic-driven, and / or other suitable drive mechanisms.

[0014] The drug delivery device 10 is configured to administer a dose of a pharmaceutical composition, such as any desired drug, into the patient's body by subcutaneous injection at a slow and controlled injection rate. The exemplary duration of administration achieved by the drug delivery device 10 may range from about 5 minutes to about 60 minutes, but is not limited to this exemplary range. The exemplary volume of the pharmaceutical composition administered by the drug delivery device 10 may range from about 0.1 milliliters to about 10 milliliters, but is not limited to this exemplary range. The amount of pharmaceutical composition administered to the patient may be adjusted. The device 10 may communicate with another device, such as a mobile device or a computer.

[0015] Referring to Figures 3-6D, according to one aspect or embodiment, the insertion mechanism 16 includes a needle hub 30 separated from the housing 20. The needle hub 30 includes a removal tab 32, an actuation button 34, a status indicator 36, a finger grip, a side grip, and an integrated cannula withdrawal tab 38. The needle hub 30 contains the indwelling cannula. The status indicator 36 may be white when unused (Figure 4A), blue when the needle is inserted and ready for injection (Figure 4B), and green when the cannula has been withdrawn (Figure 4C). As shown in Figure 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 pressing the actuation button 34, which causes the needle to automatically retract, leaving the indwelling cannula in the patient. The drug or fluid is then injected into the patient. Once the injection is complete, the cannula withdrawal tab 38 is pulled, and the cannula is retracted. Next, the needle hub 30 can be removed from the patient's skin.

[0016] Referring to Figures 6A-6D, in one embodiment, the needle hub 30 includes a hub body 42, an actuation 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 actuation 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 actuation button 34 is configured to engage with 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. The cannula 52 is configured to communicate fluidly with a fluid source, such as a fluid reservoir 12. The cannula spring 54 biases the cannula holder 50 to the storage position where the cannula 52 is positioned inside the hub body 42. The movement of the actuation button 34 is configured to engage the second actuation surface 58 of the needle holder 44 with the first actuation surface 56 of the actuation button 34, moving the needle holder 44 and the cannula holder 50 from their respective storage positions to the insertion position where the distal ends of the needle 46 and cannula 52 are positioned outside the hub body 42. The needle holder 44 is configured to return to the storage position while the cannula holder 50 remains in the insertion position. The movement of a portion of the hub body 42 is configured to disengage the connection between the cannula holder 50 and the hub body 42, allowing the cannula holder 50 to return to the storage position.

[0017] Referring again to Figures 6A to 6D, the needle holder 44 includes a passage 60 configured to allow the needle 46 to fluidly communicate with the passage 60 of the needle holder 44. At least a portion of the needle 46 is received into the cannula 52. Fluid is configured to flow from the fluid reservoir 12 through the tube 62 to the passage 60 of the needle holder 44, through the needle 46, and into the cannula 52. The cannula holder 50 includes a seal 64 that engages with the needle 46. The needle hub 30 includes a first projection 66, and the cannula holder 50 includes a second projection 68. When the cannula 52 is in the insertion position, the first projection 66 of the needle hub 66 engages with the second projection 68 of the cannula holder 50 to restrict the movement of the cannula holder 50 to the stowed position.

[0018] Referring to Figures 3-6D, the needle hub 30 includes a release tab 70, the movement of which releases the engagement between a first projection 66 of the needle hub 30 and a second projection 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 release tab 70 is configured to engage with the skin surface of a person after the needle hub 30 has been attached to a person. The actuation 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 perpendicular to the first axis 72. The first actuation surface 56 of the actuation button 34 is configured to disengage from the second actuation surface 58 of the needle holder 44 after the actuation button 34 has moved a predetermined distance along the first axis 72.

[0019] Referring to Figures 7-14, according to further aspects or embodiments, the needle hub 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 actuation 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. The movement of the actuation button 90 is configured to move the needle holder 84 and the cannula holder 94 from a retraction position where the needle 86 and cannula 96 are located within the applicator 82 or the hub body 92, to an insertion position where the distal ends of the needle 86 and cannula 96 are located outside the applicator 82 and the hub body 92. The cannula withdrawal button 98 locks the cannula holder 94 in the insertion position against the biasing force of the cannula withdrawal spring 100 when the cannula holder 94 moves from the storage position to the insertion position. As shown in Figure 10, in one embodiment, the cannula withdrawal button 98 may be omitted.

[0020] Referring to Figures 12A-12F, the needle holder 84 is configured to move to the retracted position after the cannula holder 94 has moved to the insertion position. The actuation button 90 includes an extension 102 having a drive projection 103, and the applicator 82 includes a drive surface 104 configured to engage with the drive projection 103. When the actuation button 90 is moved, the drive projection 103 engages with the needle holder 84, moving the needle holder 84 and the cannula holder 94 to the insertion position, and the drive projection 103 engages with the drive surface 104 of the applicator 82, moving the extension 102 radially outward, thereby releasing the needle holder 84 from the drive projection 103, allowing the needle retraction spring 100 to return the needle holder 84 to the retracted position. The actuation of the cannula withdrawal button 98 is configured to move the cannula holder 94 from the insertion position to the retracted position. The hub body 92 further includes an adhesive pad 105 configured to fix the hub body 92 to a human skin surface. The adhesive pad 105 includes a release tab 106 extending radially outward from the hub body 92. The actuation button 90 is received in an opening 107 defined by the 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 tube 110 is connected to the port of the cannula holder 94.

[0021] Referring to Figure 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 the patient's skin surface, removing the safety cap, and pressing the actuation button 90 on the applicator 82, which automatically actsuation 86 and retracts the indwelling cannula 96. The applicator 82 can then be removed from the hub body 92, and injection can begin. Once injection is complete, the cannula 96 can be removed from the patient by pressing the cannula withdrawal button 98, and the hub body 92 is removed from the patient's skin using the release tab 106.

[0022] Referring to Figures 13 and 14, in one aspect or embodiment, the cannula holder 94 includes a portion of the adhesive pad 105 that, when the cannula holder 94 is removed from the hub body 92, removes a portion of the adhesive pad 105 from the patient's skin and facilitates the removal of the remaining portion of the adhesive pad 105 from the patient's skin.

[0023] Referring to Figures 15-18B, the needle hub 112, according to further aspects or embodiments, includes a hub body 114, an actuation 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 return 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 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 to the retracted position. The movement of the actuation button 116 is configured to move the needle holder 118 and the cannula holder 122 from the storage position to the insertion position, and the needle holder 118 is configured to return to the storage position while the cannula holder 122 remains in the insertion position. As shown in Figure 16, in one embodiment, the needle hub 112 includes two lateral actuation push buttons 116. The needle hub 112 is used in the same manner as described above in relation to the needle hub 30 shown in Figure 5.

[0024] Referring to Figures 17-18B, the hub body 114 includes a cannula lock 136 configured to lock the cannula holder 122 into the insertion portion. The needle hub 112 includes an adhesive pad 138 configured to secure the hub body 114 to the surface of human skin, and the adhesive pad 138 includes a release tab 140. The movement of the release tab 140 is configured to disengage the cannula lock 136 and the hub body 114, allowing the cannula holder 122 to return to its retracted position. The cannula lock 136 is biased away from the cannula holder 122 via a locking spring 142, and the hub body 112 includes a hinge portion 144, which is configured to rotate when the release tab 140 moves and disengage 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 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, with at least a portion of the needle 120 being received within the cannula 124.

[0025] Referring to Figures 19-21, according to further aspects or embodiments, the needle hub 152 includes a needle holder 154 and 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 inserted position and back to the retracted position, an inlet 162 configured to fluidly communicate with a fluid reservoir 12, an outlet 164 to fluidly communicate with the needle 156, and a pressure interlock 160 including a locking member 166. The locking member 166 has a first position in which the locking member 166 prevents the actuation of the needle actuation assembly 158, and a second position in which the locking member 166 allows the actuation of the needle actuation assembly 158. The locking member 166 is moved from the first position to the second position based on the pressure in the pressure interlock 160.

[0026] Referring to Figure 21, the locking member 166 isolates the inlet 162 from the outlet 164 when the locking member 166 is in a first position, and the locking member 166 allows fluid communication between the inlet 162 and the outlet 164 when the locking member 166 is in a second position. The needle hub 152 further includes a tube 168 connected to the outlet 164 and in fluid communication with the needle 156. The locking member 166 includes an opening 170, and a portion of the needle actuation assembly 158 extends through the opening 170 of the locking member 166 when the locking member 166 is in a second position. 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. The cam block 178 defines the cam track 172 and extends through the opening 170 of the locking member 166 when the locking member 166 is in a second position. The needle actuation assembly 158 further includes a cannula 180, the needle 156 which is received within the cannula 180 when the needle holder 156 is in a retracted position.

[0027] Referring again to Figures 19-21, the needle hub 152 includes a housing 182 and a removal tab 184. The top surface 186 of the housing 182 is smooth and has no operating button. As shown in Figure 20, 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 operating the drive mechanism 27 to insert the needle 156, which is automatically retracted leaving the indwelling cannula 180. After the injection is complete, the needle hub 152 is removed by grasping the removal tab 184 and lifting it upward, while the cannula 180 is automatically retracted. In one aspect or embodiment, pulling the removal tab 184 reduces the pressure of the pressure interlock 160, causing the cannula holder and / or cannula 180 to automatically retract.

[0028] Referring to Figures 22-25, further embodiments or aspects of drug delivery devices 190 and needle hubs 192 are shown. 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 hub 192 of Figures 22-25 are modular, however, in which the needle hub 192 is optionally integrated into the drug delivery device 190 (Figure 24), or the needle hub 192 is separated from the drug delivery device 190 and separately mounted on the patient's skin surface (Figure 25). In one embodiment or aspect, the drug delivery device 190 and needle hub 192 may remain connected or integrated for lower drug doses and separated by a fluid connection between them for larger drug doses.

[0029] Referring to Figures 26A-26C, a needle hub 200 having a skin tent reduction feature according to one aspect or embodiment is shown. The needle hub 200 includes a rotational engagement mechanism 202, a portion of which first contacts and adheres to the patient's skin surface, and then rotates further once the needle hub 200 is fully pressed against the skin surface. The initial adhesion and further rotation of the rotational engagement mechanism stretch the skin and reduce the skin tent.

[0030] Referring to Figures 27A-27C, a needle hub 204 having a skin tent reduction feature according to one aspect or embodiment is shown. The needle hub 204 includes an adhesive ring 206 that is pressed onto the skin before needle insertion when an activation button is pressed or activated. The adhesive ring 206 stretches the skin and reduces skin tent.

[0031] Referring to Figures 28A-28C, a needle hub 208 having a skin tent reduction feature according to one aspect or embodiment is shown. The needle hub 208 includes a skin stretching member 210 that is initially adhered to the patient's skin surface and then moved radially outward. An activation button 212 engages with the skin stretching member 210, causing it to move radially outward, which locally stretches the skin and reduces skin tent.

[0032] The skin tent reduction features and associated mechanisms shown in Figures 26A to 28C may be incorporated into any of the needle hub or needle insertion configurations or embodiments disclosed herein.

[0033] Referring to Figures 29-33, according to one aspect or embodiment, the needle actuation assembly 220 includes a clip 222 that holds the needle actuator body 224 and the cannula body 226 in a retracted position, which are biased by a spring 228. When the clip 222 is pushed inward, the needle actuator body 224 and the cannula body 226 are released, causing the 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 an inclined feature that rotates and / or twists the cannula body 226. The cannula body 226 is held in place by the clip 236 within the wall of the housing 233. After the cannula body 226 has rotated and / or twisted, the needle actuator body 224 is released, and the return spring 238 retracts the needle 230.

[0034] Referring to Figures 34 and 35, in further embodiments or configurations, the needle hub 240 is configured to be isolated from the rest of the drug delivery device. The needle hub 240 includes a protective cap 242, a needle insertion mechanism 244, a connection configuration 246 configured to position the needle hub 240 in fluid communication with the reservoir 12 and drive mechanism 27, a fluid path 248, and an adhesive pad and / or layer 250. The connection configuration 246 may provide a sterile connection between the needle hub 240 and the reservoir 12. Needle retraction may be manually or automatically actuated at the end of a dosing event and / or via a trigger mechanism connected to 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 (fully or partially at the end of translation). The fluid path 248 and the connection configuration 246, along with the sterilization of the subsystem and reservoir, remain sterile until the connection is established.

[0035] Referring to Figures 36-39, according to further embodiments or designs, the drug delivery device 252 includes a flexible reservoir 254, where at least a portion of the flexible reservoir 254 is positioned externally from the rest 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 mL to 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 separated from the drug delivery device 252 and fluidly connected to the drug delivery device 252 via a fluid pathway 256 such as a tube. The flexible reservoir 254 may be attached separately to the patient via a belt clip, harness, strap, or other suitable configuration.

[0036] Referring to Figure 40, the drug delivery device in 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 the fluid path to the needle and / or cannula. The valve assembly 260 is similar to and may operate in the same manner as the valve assembly shown and described in Patent Document 1.

[0037] Referring to Figures 41-48, a pressure interlock 270 according to further aspects or embodiments of this application is shown. The pressure interlock 270 is similar to and functions similarly to the pressure interlock 160 described above in relation to Figures 19-21. Similar reference numerals are used for similar elements. As shown in Figure 48, the pressure interlock 270 includes a cylinder 272, the locking member 166 includes a piston 274, and the inlet 162 and outlet 164 of the pressure interlock 270 are in fluid communication with the cylinder 272. The pressure interlock 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 breakthrough pressure of 41 psi. In one aspect or embodiment, the exhaust port 276 includes a one-way valve. The pressure interlock 270 includes a tube 280 connected to the outlet 164 and in fluid communication with a 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 accommodate the downward movement of the needle 156 and the subsequent retraction of the needle 156.

[0038] Referring to Figures 42 and 43, in one aspect or embodiment, the cam member 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 attached to a cannula holder 288.

[0039] Referring to Figures 44 and 45, in one aspect or embodiment, after the needle 156 and cannula 180 have been activated, the cannula holder 288 is locked in the insertion position via one or more clips 290 provided on the base plate or housing 292 of the drug delivery device.

[0040] Referring to Figures 46 and 47, in one aspect or embodiment, the locking member 166 includes a seal 294 that engages with the cylinder 272 and forms a seal. The seal 294 may be a rubber stopper or an O-ring, but other suitable sealing arrangements may be used. The seal 294 is received by the sealing engagement portion 296 of the locking member 166.

[0041] Referring to Figure 48, the pressure interlock 270 operates in the same manner as the pressure interlock 160 in Figure 21. Before activation, the locking member 166 is positioned adjacent to the inlet 162 so that the inlet 162 is isolated from the outlet 164. The needle actuation assembly 158 prevents the locking member 166 from acting to shut off or engage the cam block 178. When fluid is delivered to the inlet 162 via a drug delivery device such as the drug delivery device 10 shown in Figures 1 and 2, the increase in pressure in the cylinder 272 moves the locking member 166 and seal 294 to the position shown in Figure 48, so that the opening 170 of the locking member 166 aligns with the cam block 178, enabling the operation of the needle 156 and cannula 180, and also creating fluid communication between the inlet 162 and the outlet 164. Once the fluid is introduced into the cylinder 272, air is expelled through the exhaust port 276. Although a cylindrical cylinder 272 is shown, other suitable shapes of cylinders, such as a rounded rectangular cylinder or a barrel, may be used.

[0042] The present invention has been described in detail for illustrative purposes based on what is currently considered to be the most practical and preferred embodiments or aspects, but such details are for that purpose only, and the present invention is not limited to the disclosed embodiments or aspects, but rather intended to encompass modifications and equivalent arrangements that fall within the spirit and scope of the appended claims. For example, the present invention is intended to be, wherever possible, so that one or more features of any embodiment can be combined with one or more features of any other embodiment.

Claims

1. A needle hub for a drug delivery device, A needle holder, a needle attached to the needle holder, A needle operating assembly configured to move the needle holder from the storage position to the insertion position and return it to the storage position, 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 member having a first position for preventing the operation of the needle actuation assembly and a second position for enabling the operation of the needle actuation assembly, the locking member being moved from the first position to the second position based on the pressure in the pressure interlock, the locking member isolating the inlet from the outlet when the locking member is in the first position, the locking member including an opening, the portion of the needle actuation assembly extending through the opening of the locking member when the locking member is in the second position; and a needle hub comprising a pressure interlock.

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

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

4. The needle hub according to claim 2, wherein the pressure interlock further comprises an exhaust port configured to discharge air from the cylinder.

5. The needle hub according to claim 4, wherein the exhaust port is provided with a hydrophobic film.

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

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

8. The needle hub according to claim 7, wherein the needle operating assembly comprises a cam track, a cam member, and an operating spring for biasing the cam member relative to the cam track.

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

10. The needle hub according to claim 1, further comprising a skin tent reduction mechanism having an adhesive surface configured to adhere to the surface of human skin, wherein the skin tent reduction mechanism is configured to stretch the skin surface at a position where the needle penetrates the skin surface.

11. The needle hub according to claim 1, further comprising a cannula, wherein the needle is received within the cannula when the needle holder is in the retracted position.

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