Drug delivery device with needle hub

Abstract

The drug delivery device includes a housing, a fluid reservoir received within the housing, a drive assembly configured to eject fluid from the fluid reservoir, a needle hub actuator attached to the housing, and a needle hub at least partially received by the housing. The needle hub includes a hub body, a needle holder having a needle attached to the needle holder, and a cannula holder having a cannula attached to the cannula holder. The needle hub actuator is configured to move the needle holder and the cannula holder from a retracted position where the needle and cannula are positioned within the hub body to an inserted position where the needle and cannula are positioned within the hub body. The needle hub is removable from the housing.

Description

Technical Field

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[0001] Cross - reference to related applications This application claims priority to U.S. Provisional Application No. 63 / 134,054, filed on January 5, 2021, the entire disclosure of which is incorporated herein by reference.

Background Art

[0002] Field of the Invention This disclosure relates to a drug delivery device having a needle hub.

[0003] Description of Related Art Wearable medical devices, such as auto - injectors, have the advantage of being able to provide treatment to a patient while being worn away from a clinical facility and / or unobtrusively under the patient's clothing. A wearable medical device can be applied to the patient's skin and, after the wearable medical device is applied to the patient's skin, is configured to automatically deliver a dose of a pharmaceutical composition within a predetermined time. After the device has delivered the pharmaceutical composition to the patient, the patient may then remove and discard the device.

[0004] Summary of the Invention In one aspect or embodiment, a drug delivery device includes a housing, a fluid reservoir received within the housing, a drive assembly configured to eject fluid from the fluid reservoir, a needle hub actuator attached to the housing, and a needle hub at least partially received by the housing. The needle hub includes a hub body having a patient contact surface, a housing connection portion that attaches the hub body to the housing, a needle holder to which a needle is attached, and a cannula holder to which a cannula is attached. The needle hub actuator is configured to move the needle holder and the cannula holder from a retracted position in which the needle and the cannula are positioned within the hub body to an inserted position in which the needle and the cannula are positioned within the hub body. The needle hub is removable from the housing.

[0005] The needle hub actuator may include a needle holder connector, the needle holder may include an actuator connector, and the needle holder connector is configured to connect to the actuator connector. The hub body may define a cam path, and the needle holder may include a cam member that is received within the cam path, and the axial displacement of the needle holder is configured to rotate the needle holder, connecting the needle holder connector of the needle hub actuator to the actuator connector of the needle holder. The needle holder connector of the needle hub actuator and the actuator connector of the needle holder may form a bayonet connector.

[0006] The hub body may include a cannula lock configured to fix the cannula holder in the insertion position. The cannula lock may include a projection configured to engage with the cannula holder when the cannula holder is in the insertion position. The hub body may include a needle projection configured to engage with the needle holder when the needle holder is in the retracted position, and the hub body may include a cannula projection configured to engage with the cannula holder when the cannula holder is in the retracted position.

[0007] The hub body may define the cannula orbit, and the cannula holder may define an orbital projection that is received within the cannula orbit, where the cannula orbit is linear.

[0008] The housing connection portion of the hub body may be received within an opening defined by the housing. The housing connection portion may include a retaining member configured to engage with the housing and secure the hub body to the housing. The housing connection portion may also include a release member configured to engage with a needle hub actuator and release the hub body from the housing. The retaining member and the release member may be positioned on an extension, and the extension may be configured to be biased radially outward.

[0009] The patient contact surface may include an adhesive pad configured to secure the hub body to the surface of human skin. The cannula holder may include a seal that engages with the needle. The cannula holder may include a port that fluidically communicates with the cannula, and the port of the cannula holder is in fluid communication with a fluid reservoir via a tube. The tube may be received in a slot defined by the hub body. The needle holder and cannula holder may be configured to be positioned within the housing when the needle hub actuator moves the needle holder and cannula holder from the retracted position to the inserted position.

[0010] Brief explanation of the drawing The above and other features and advantages of this disclosure, as well as the methods for achieving them, will become more apparent and the disclosure itself will be better understood by referring to the following description of embodiments of this disclosure, which will be provided together with the accompanying drawings. [Brief explanation of the drawing]

[0011] [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 the needle has been inserted. [Figure 4C] Figure 4C is a top view of the needle hub in Figure 3, showing the indicator after the cannula has been withdrawn. [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 in Figure 3, illustrating the operation of the activation button. [Figure 6B]Figure 6B is a schematic view of the needle hub of FIG. 3, showing the movement of the needle and cannula from the retracted position to the inserted position. [Figure 6C] Figure 6C is a schematic view of the needle hub of FIG. 3, showing the needle in the retracted position and the cannula in the inserted position. [Figure 6D] Figure 6D is a schematic view of the needle hub of FIG. 3, showing the movement of the cannula to the retracted 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 of FIG. 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 position before use of the needle hub. [Figure 12B] Figure 12B is a schematic view of the needle hub of FIG. 7, showing the state in which the needle hub is actuated. [Figure 12C] Figure 12C is a schematic view of the needle hub of FIG. 7, showing the state in which the needle is retracted. [Figure 12D] Figure 12D is a schematic view of the needle hub of FIG. 7, showing the needle in the retracted position. [Figure 12E] Figure 12E is a schematic view of the needle hub of FIG. 7, showing the state in which the applicator is 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 retracted 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 Figure 15, showing the cannula insertion position. [Figure 18B] Figure 18B is a cross-sectional view of the needle hub of Figure 15, showing the cannula retraction 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 view showing a method of using the needle hub of 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 a 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 the needle hub of Figure 22. [Figure 24] Figure 24 is a perspective view of the drug delivery device and the needle hub of Figure 22, showing the state in which the drug delivery device and the needle hub are connected while delivering a drug. [Figure 25] Figure 25 is a perspective view of the drug delivery device and the needle hub of Figure​​​​​​​​​​ [Figure 27A] Figure 27A is a cross-sectional view of a needle hub according to a further aspect or embodiment of the present 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 the present application, showing engagement with the skin surface. [Figure 27C] Figure 27C is a cross-sectional view of a needle hub according to a further aspect or embodiment of the present application, showing the insertion of a needle. [Figure 28A] Figure 28A is a cross-sectional view of a needle hub according to a further aspect or embodiment of the present 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 the present application, showing engagement with the skin surface. [Figure 28C] Figure 28C is a cross-sectional view of a needle hub according to a further aspect or embodiment of the present application, showing the insertion of a needle. [Figure 29] Figure 29 is a perspective view of a needle operating assembly according to a further aspect or embodiment of the present application, showing the non-operating 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 operating assembly shown in Figure 29, indicating the non-operating position. [Figure 32] Figure 32 is a cross-sectional view of the needle operating assembly shown in Figure 29, indicating the operating position. [Figure 33] Figure 33 is a cross-sectional view of the needle operating assembly shown in Figure 29, indicating the retracted 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, and shows 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 device attached to the patient. [Figure 40] Figure 40 is a partial cross-sectional view of a prior art valve assembly. [Figure 41] Figure 41 is a perspective view of a drug delivery device and needle hub according to a further aspect or embodiment of the present application, showing the needle hub positioned within the drug delivery device. [Figure 42] Figure 42 is a perspective view of the drug delivery device and needle hub shown in Figure 41, with the needle hub separated from the drug delivery device. [Figure 43] Figure 43 is a perspective view of the needle hub shown in Figure 41, indicating the retraction positions of the needle holder and cannula holder. [Figure 44] Figure 44 is a perspective view of the needle hub in Figure 41, showing the retraction position of the needle holder and cannula holder, with a portion of the needle hub made transparent for clarity. [Figure 45] Figure 45 is a cross-sectional view of the needle hub shown in Figure 41, illustrating the state in which the needle hub is fixed to the drug delivery device. [Figure 46] Figure 46 is a cross-sectional view of the needle hub shown in Figure 41, illustrating the state in which the needle hub is fixed to the drug delivery device. [Figure 47] Figure 47 is a partial perspective view of the needle hub in Figure 41, showing the actuator interacting with the needle hub. [Figure 48] Figure 48 is a cross-sectional view of the needle hub in Figure 41, showing the needle holder engaged with the actuator. [Figure 49] Figure 49 is a partial perspective view of the needle hub in Figure 41, with a portion of the needle hub made transparent for clarity to show the needle holder engaged with the actuator. [Figure 50] Figure 50 is a partial perspective view of the needle hub in Figure 41, with a portion of the needle hub made transparent for clarity, showing the state in which the needle holder is displaced by the actuator. [Figure 51]Figure 51 is a partial perspective view of the needle holder and actuator of the needle hub and drug delivery device shown in Figure 41. [Figure 52] Figure 52 is a cross-sectional view of the needle hub shown in Figure 41, and shows the needle holder and cannula holder at the insertion position. [Figure 53] Figure 53 is a cross-sectional view of the needle hub shown in Figure 41, and shows the needle holder in the retraction position and the cannula holder in the insertion position. [Figure 54] Figure 54 is a partial front view of the needle hub in Figure 41, showing the actuator released from the needle hub. [Figure 55] Figure 55 is a partial perspective view of the needle hub in Figure 41, showing the actuator released from the needle holder.

[0012] Corresponding reference letters indicate the corresponding parts through multiple figures. The examples set forth herein illustrate exemplary embodiments of the disclosure and shall not be construed as limiting the scope of the disclosure in any way. [Modes for carrying out the invention]

[0013] Detailed description of the invention Spatial or directional terms such as "left," "right," "inside," "outside," "up," and "down" are not considered limiting because the present invention can envision various alternative directions.

[0014] All numerical values ​​used herein and in the claims should be understood to be modified in all cases by the term “approximately,” meaning a range of plus or minus 10% of the stated value. Where used herein and in the claims, the singular forms “a,” “an,” and “the” include multiple references unless the context clearly indicates otherwise. Terms such as “first,” “second,” etc., do not imply a specific order or chronological sequence, but rather mean different conditions, characteristics, or elements. “At least” means “equal to or greater than.”

[0015] 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 embodiment, the drug delivery device 10 is a wearable auto-injector. The drug delivery device 10 may be placed on the patient's skin and triggered to inject a pharmaceutical composition from the reservoir 12 into the patient. The drug delivery device 10 may be pre-filled with a pharmaceutical composition or 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 sensor module 24, a vision driver 25, and / or a voice driver 26. The drug delivery device 10 includes a drive mechanism 27 configured to discharge 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.

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

[0017] Referring 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 a removal tab 32, an activation button 34, a status indicator 36, a finger grip, a side grip, and an integrated cannula pull-out tab 38. The needle hub 30 includes an indwelling cannula. The status indicator 36 may be white when not in use (Figure 4A), blue when the needle is inserted and ready for injection (Figure 4B), and green when the cannula is pulled out (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 activation 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 pull-out tab 38 is pulled, which retracts the cannula. The needle hub 30 can then be removed from the patient's skin.

[0018] Referring to Figures 6A to 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 retracted position where the cannula 52 is positioned inside the hub body 42. The movement of the actuation button 34 is configured to engage the first actuation surface 56 of the actuation button 34 with the second actuation surface 58 of the needle holder 44, causing the needle holder 44 and the cannula holder 50 to move from their respective retracted positions to the insertion position where the terminal ends of the needle 46 and cannula 52 are positioned outside the hub body 42, so that the needle holder 44 returns to the retracted position and the cannula holder 50 remains in the insertion position. The movement of a portion of the hub body 42 is configured to release the connection between the cannula holder 50 and the hub body 42, allowing the cannula holder 50 to return to the retracted position.

[0019] Referring again to Figures 6A-6D, the needle holder 44 includes a passage 60 configured to communicate fluidly with the fluid reservoir 12, and the needle 46 is in fluid communication with the passage 60 of the needle holder 44. At least a portion of the needle 46 is received in the cannula 52. The fluid is configured to flow from the fluid reservoir 12 through the tube 62 into 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 engaged 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, restricting the movement of the cannula holder 50 to the retraction position.

[0020] Referring to Figures 3 to 6D, the needle hub 30 includes a removal tab 70, the movement of which releases the engagement between the first projection 66 of the needle hub 30 and the 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 removal 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 the 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.

[0021] Referring to Figures 7-14, a needle hub 80 according to a further embodiment or model 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 positioned within the applicator 82 or the hub body 92, to an insertion position where the terminal ends of the needle 86 and cannula 96 are positioned outside the applicator 82 and the hub body 92. The cannula pull-out button 98 locks the cannula holder 94 in the insertion position against the biasing force of the cannula retraction spring 100 when the cannula holder 94 is moved from the retraction position to the insertion position. As shown in Figure 10, in one embodiment, the cannula pull-out button 98 may be omitted.

[0022] Referring to Figures 12A to 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 cannula pull-out 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 removal 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 communicate fluidly with the fluid reservoir 12, and the cannula 96 communicates fluidly with the port 109. The tube 110 is connected to the port of the cannula holder 94.

[0023] 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 actsuates and retracts the needle 86, leaving 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 pull-out button 98 may be pressed to remove the cannula 96 from the patient, and the hub body 92 is removed from the patient's skin using the removal tab 106.

[0024] Referring to Figures 13 and 14, in one aspect or embodiment, the cannula holder 94 includes a portion of the adhesive pad 105, which, when the cannula holder 94 is removed from the hub body 92, allows for the removal of the 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.

[0025] Referring to Figures 15 to 18B, a needle hub 112 according to further embodiments or models 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 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 to the retracted position. The movement of the activation button 116 is configured to move the needle holder 118 and the cannula holder 122 from the retracted position to the insertion position, with the needle holder 118 returning to the retracted position and the cannula holder 122 remaining in the insertion position. As shown in Figure 16, in one embodiment, the needle hub 112 includes two lateral activation 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.

[0026] 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 fix the hub body 114 to the surface of human skin, and the adhesive pad 138 includes a removal tab 140. The movement of the removal tab 140 is configured to disengage the cannula lock 136 from the hub body 114, allowing the cannula holder 122 to return to the retracted position. The cannula lock 136 is biased to move away from the cannula holder 122 via a locking spring 142, and the hub body 112 includes a hinged portion 144, which is configured to rotate as the removal tab 140 moves to disengage from the cannula lock 136. The cannula holder 122 includes a port 146 configured to communicate fluidly with the fluid reservoir 12, and the cannula 124 is in fluid communication with the port 146. The needle hub 112 includes a tube 148 connected to the port 146 of the cannula holder 122. The cannula holder 122 includes a seal 150 engaged with the needle 120, and at least a portion of the needle 120 is received within the cannula 124.

[0027] Referring to Figures 19-21, a needle hub 152 in a further embodiment or configuration includes a needle holder 154, a needle 156 attached to the needle holder 154, a needle actuation assembly 158 configured to move the needle holder 154 from a retracted position to an inserted position and back to the retracted position, and a pressure interlock 160 including an inlet 162 configured to fluidly communicate with a fluid reservoir 12, an outlet 164 fluidly communicating with the needle 156, and a locking member 166. The locking member 166 has a first position in which the locking member 166 prevents the operation of the needle actuation assembly 158, and a second position in which the locking member 166 allows the operation 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.

[0028] Referring to Figure 21, when the locking member 166 is in the first position, the locking member 166 isolates the inlet 162 from the outlet 164, and when the locking member 166 is in the second position, the locking member 166 allows fluid communication between the inlet 162 and the outlet 164. 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 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, and the cam block 178 extends through the opening 170 of the locking member 166 when the locking member 166 is in the second position. The needle acting assembly 158 further includes a cannula 180, and when the needle holder 156 is in the retracted position, the needle 156 is received within the cannula 180.

[0029] 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 activating the drive mechanism 27 to insert the needle 156, which then automatically retracts, 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, and the cannula 180 automatically retracts. In one aspect or embodiment, pulling the removal tab 184 causes a decrease in pressure in the pressure interlock 160, causing the cannula holder and / or cannula 180 to automatically retract.

[0030] Referring to Figures 22-25, further embodiments or designs of drug delivery devices 190 and needle hubs 192 are shown. The drug delivery device 190 may be the same as the drug delivery device 10 shown in Figures 1 and 2. The drug delivery devices 190 and needle hubs 192 of Figures 22-25, however, are modular, and the needle hub 192 may be optionally integrated into the drug delivery device 190 (Figure 24), or the needle hub 192 may be separated from the drug delivery device 190 and attached separately to the patient's skin surface (Figure 25). In one embodiment or design, the drug delivery device 190 and needle hub 192 may remain connected or integrated for smaller drug volumes, and remain separated with a fluid connection between them for larger drug volumes.

[0031] Referring to Figures 26A-26C, a needle hub 200 with a skin tenting reduction feature is shown according to one aspect or embodiment. The needle hub 200 includes a rotational engagement mechanism 202, the 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 skin tenting.

[0032] Referring to Figures 27A to 27C, a needle hub 204 with a skin tenting reduction feature according to one aspect or embodiment is shown. The needle hub 204 includes an adhesive ring 206 which is pressed against the skin before needle insertion when the activation button is pressed or activated. The adhesive ring 206 stretches the skin and reduces skin tenting.

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

[0034] The skin tenting reduction features and related mechanisms shown in Figures 26A to 28C may be incorporated into any of the needle hub or needle insertion arrangements or embodiments disclosed herein.

[0035] Referring to Figures 29-33, a needle actuator assembly 220 according to one aspect or embodiment includes a clip 222 that holds the needle actuator body 224 and the cannula body 226 in the retracted position, both of which are biased by a spring 228. Pushing the clip 222 inward releases the needle actuator body 224 and the cannula body 226, causing the insertion of the needle 230 and the cannula 232. When the cannula body 226 reaches the bottom of the housing 233, it contacts an angled feature, causing the cannula body 226 to rotate and / or twist. The cannula body 226 is held in place by a clip 236 on 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.

[0036] 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 arrangement 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 arrangement 246 may provide a sterile connection between the needle hub 240 and the reservoir 12. Needle retraction may be manually actuated or automatically actuated via a trigger mechanism and / or a wireless connection between the needle hub 240 and a drive unit connected to the end of an administration event. The trigger mechanism may include a flexible rigid connection for movement of the plunger rod (whole or partial movement at the end of translation). The fluid path 248 and the connection arrangement 246 are kept sterile until the connection is established by sterilization of the subsystem and reservoir.

[0037] Referring to Figures 36-39, a further embodiment or designation of the drug delivery device 252 includes a flexible reservoir 254, at least a portion of which 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 fitted to 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 separately attached to the patient via a belt clip, harness, strap, or other suitable arrangement.

[0038] Referring to Figure 40, a drug delivery device according to 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 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.

[0039] Referring to Figures 41-55, further embodiments or designs of drug delivery devices 270 and needle hubs 272 are shown. The drug delivery device 270 may be similar to the drug delivery device 10 shown in Figures 1 and 2. In one embodiment or design, the drug delivery device 270 includes a housing 20, a fluid reservoir 12 received within the housing 20, and a drive mechanism 27 configured to discharge fluid from the fluid reservoir 12. The drug delivery device 270 further includes a needle hub actuator 274 attached to the housing 20. The needle hub 272 is at least partially received in the housing 20. The needle hub 272 includes a hub body 276 having a patient contact surface 278, a housing connection portion 280 for attaching the hub body 276 to the housing 20, a needle holder 282 having a needle 284 attached to the needle holder 282, and a cannula holder 286 having a cannula 288 attached to the cannula holder 286. The needle hub actuator 274 is configured to move the needle holder 282 and the cannula holder 286 from a retracted position where the needle 284 and cannula 288 are positioned within the hub body 276, to an inserted position where the needle 284 and cannula 288 are positioned within the hub body 276. The needle hub 272 is removable from the housing 20.

[0040] Referring to Figures 43-55, the needle hub actuator 274 includes a needle holder connector 290, and the needle holder 282 includes an actuator connector 292, which is configured to connect to the actuator connector 292. The hub body 276 defines a cam track 294, and the needle holder 282 includes a cam member 296 received within the cam track 294. The axial displacement of the needle holder 282 is configured to rotate the needle holder 282, connecting the needle holder connector 290 of the needle hub actuator 274 to the actuator connector 292 of the needle holder 282. As is clearly shown in Figures 49-51, the needle holder connector 290 of the needle hub actuator 274 and the actuator connector 292 of the needle holder 282 form a bayonet connector, although other suitable connection arrangements may be used. As shown in Figures 52 and 53, the hub body 276 includes a cannula lock 298 configured to fix the cannula holder 286 in the insertion position. In one embodiment, the cannula lock 298 is received by a corresponding recess in the cannula holder 286, but other suitable arrangements may be utilized. As shown in Figures 48, 52, and 53, the hub body 276 includes a needle projection 300 configured to engage with the needle holder 282 when the needle holder 282 is in the retracted position, and the hub body 276 includes a cannula projection 302 configured to engage with the cannula holder 286 when the cannula holder 286 is in the retracted position.

[0041] Referring again to Figures 41-55, the hub body 276 defines a cannula track 304, and the cannula holder 286 includes a track projection 306 received within the cannula track 304. The cannula track 304 is linear, which corresponds to the linear, non-rotational movement of the cannula holder 286 between the retraction position and the insertion position. As clearly shown in Figure 47, the housing connection portion 280 of the hub body 276 is received within an opening 308 defined by the housing 20. The housing connection portion 280 includes a retaining member 310 configured to engage with the housing 20 and fix the hub body 276 to the housing 20. The housing connection portion 280 also includes a release member 312 configured to engage with the needle hub actuator 274 and release the hub body 276 from the housing 20. The retaining member 310 and the release member 312 are positioned on an extension 314, which is configured to be biased radially outward. The patient contact surface 278 includes an adhesive pad 316 configured to secure the hub body 276 to the surface of human skin. The cannula holder 286 includes a seal 318 that engages with the needle 284. The cannula holder 286 includes a port 320 that is in fluid communication with the cannula 288. The port 320 of the cannula holder 286 is in fluid communication with a fluid reservoir via a tube 322. The tube 322 is received in a slot 324 defined by the hub body 276.

[0042] Referring again to Figures 43-55, during or after assembly, the needle hub 272 is connected to the housing 20 of the drug delivery device 270 by inserting the retaining member 310 into the opening 308. The needle hub 272 is attached to the skin surface of a person by placing the needle hub 272 on the skin surface with the needle hub 272 attached to the drug delivery device 270 and operating the needle hub actuator 274. The needle hub actuator 274 is movable linearly or axially relative to the drug delivery device 270. The needle hub actuator 274 may be driven by an electric motor, hydraulics, pneumatics, or other appropriate arrangement. During the initial movement of the needle hub actuator 274, the needle hub actuator 274 engages with the needle holder 282 and moves axially, causing the needle holder 282 to rotate so that the cam member 296 moves through the curved portion of the cam track 294. The rotation of the needle holder 282 connects the needle hub actuator 274 to the needle holder 282 via the needle holder connector 290 and the actuator connector 292.

[0043] The needle hub actuator 274 continues to move axially to move the needle holder 282 and the cannula holder 286 to the insertion position (Figure 52). The needle hub actuator 274 retracts the needle holder 282 while keeping it fixed to the needle hub actuator 274, thereby moving the needle holder 282 back to the retracted position. The cannula holder 286 remains in the insertion position because the cannula lock 298 is engaged with the cannula holder 286. Once the needle hub actuator 274 and the needle holder 282 have reached their initial positions, the needle holder 282 rotates back to its initial position, which releases the needle hub actuator 274 from the needle holder 282. When the needle hub actuator 274 is fully retracted, it engages with the release member 312 of the housing connector 280, deflecting the housing connector 280 radially outward, thereby releasing the needle hub 272 from the drug delivery device 270, allowing the drug delivery device 270 to be separated from the needle hub 272. The drug delivery device 270 can then deliver the drug to the patient through the fluid reservoir 12, the tube 322, and the cannula 288.

[0044] While the present invention is described in detail for the purpose of illustrating what is currently considered the most practical and preferred embodiment, such details are for that purpose only, and it should be understood that the present invention is not limited to the disclosed embodiments, but rather intended to cover modifications and equivalent arrangements within the spirit and scope of the appended claims. For example, it should be understood that, to the extent possible, the present invention is intended to allow one or more features of any embodiment to be combined with one or more features of any other embodiment.

Claims

1. A drug delivery device, housing, A fluid reservoir received within the housing, A drive assembly configured to discharge fluid from the fluid reservoir, The needle hub actuator attached to the housing, and A needle hub, which is at least partially received by the housing, wherein the needle hub is A hub body having a patient contact surface and a housing connection part for attaching the hub body to the housing, The needle holder having a needle attached to the needle holder, and A cannula holder having a cannula attached to the cannula holder, comprising a needle hub, Equipped with, The needle hub actuator is movable relative to the housing from a first position to a second position spaced apart from the first position, the second position of the needle hub actuator being closer to the patient contact surface of the hub body than the first position of the needle hub actuator, and the needle hub actuator is configured to move the needle holder and the cannula holder from a retraction position where the needle and cannula are positioned inside the hub body to an insertion position where the terminal ends of the needle and cannula are positioned outside the hub body, and the needle hub is removable from the housing. A drug delivery device wherein the housing connection portion of the hub body is received in an opening defined by the housing, the housing connection portion includes a retaining member configured to engage with the housing to fix the hub body to the housing, the housing connection portion includes a release member, and the release member of the housing connection portion is configured to engage with the needle hub actuator to release the hub body from the housing when the needle hub actuator moves from the second position to the first position, and the needle hub actuator is released from the needle holder.

2. The drug delivery device according to claim 1, wherein the needle hub actuator is provided with a needle holder connector, the needle holder is provided with an actuator connector, and the needle holder connector is connected to the actuator connector.

3. The drug delivery device according to claim 2, wherein the hub body defines a cam trajectory, the needle holder comprises a cam member received within the cam trajectory, and the axial displacement of the needle holder rotates the needle holder, connecting the needle holder connector of the needle hub actuator to the actuator connector of the needle holder.

4. The drug delivery device according to claim 3, wherein the needle holder connector of the needle hub actuator and the actuator connector of the needle holder form a bayonet connector.

5. The drug delivery device according to claim 4, wherein the hub body comprises a cannula lock configured to fix the cannula holder in the insertion position.

6. The drug delivery device according to claim 5, wherein the cannula lock is configured to protrude and be received by a corresponding recess of the cannula holder when the cannula holder is in the insertion position.

7. The drug delivery device according to claim 3, wherein the hub body comprises a needle projection configured to engage with the needle holder when the needle holder is in the retracted position, and the hub body comprises a cannula projection configured to engage with the cannula holder when the cannula holder is in the retracted position.

8. The drug delivery device according to claim 3, wherein the hub body defines a cannula trajectory, the cannula holder has a trajectory projection received within the cannula trajectory, and the cannula trajectory is linear.

9. The drug delivery device according to claim 1, wherein the retaining member and the release member are positioned on the extension and the extension is configured to be biased radially outward.

10. The drug delivery device according to claim 1, wherein the patient contact surface comprises an adhesive pad configured to fix the hub body to the surface of human skin.

11. The drug delivery device according to claim 1, wherein the cannula holder comprises a seal that engages with the needle.

12. The drug delivery device according to claim 11, wherein the cannula holder has a port that is in fluid communication with the cannula, and the port of the cannula holder is in fluid communication with the fluid reservoir via a tube.

13. The drug delivery device according to claim 12, wherein the tube is received in a slot defined by the hub body.

14. The drug delivery device according to claim 1, wherein the needle holder and the cannula holder are configured to be positioned within the housing when the needle hub actuator moves the needle holder and the cannula holder from the retraction position to the insertion position.

Images