Needle hub for drug delivery device

Abstract

We provide needle hubs for drug delivery devices. [Solution] The needle hub for a drug delivery device includes a hub body, an activation button, a needle holder movable relative to the hub body, a needle attached to the needle holder, a needle spring that biases the needle holder to a retracted position in which the needle is positioned within the hub body, a cannula holder movable relative to the hub body and the needle holder, a cannula attached to the cannula holder, the cannula being configured to communicate fluidly with a fluid source, and a cannula spring that biases the cannula holder to a retracted position. The movement of a portion of the hub body is configured to release the coupling between the cannula holder and the hub body, allowing the cannula holder to return to the retracted position.

Description

Technical Field

[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 content of which is incorporated herein by reference.

[0002] Field of the Invention The present disclosure relates to a needle hub for a drug delivery device.

Background Art

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

Prior Art Documents

Patent Documents

[0004]

Patent Document 1

Summary of the Invention

Problems to be Solved by the Invention

[0005] Provide a needle hub for a drug delivery device.

Means for Solving the Problems

[0006] Summary of the Invention In one embodiment or aspect, a needle hub for a drug delivery device includes a hub body, an activation button movable relative to the hub body, the activation button having a first operating surface, and a needle holder movable relative to the hub body, the needle holder having a second operating surface. The first operating surface of the activation button is configured to engage with the second operating surface of the needle holder. The needle hub further includes a needle attached to the needle holder, a needle spring that biases the needle holder to a retracted position in which the needle is positioned within the hub body, a cannula holder movable relative to the hub body and the needle holder, a cannula attached to the cannula holder, the cannula being configured to be in fluid communication with a fluid source, and a cannula spring that biases the cannula holder to a retracted position in which the cannula is positioned within the hub body. The movement of the activation button is configured such that the first operating surface of the activation button engages with the second operating surface of the needle holder, causing the needle holder and cannula holder to move from their respective retracted positions to an insertion position where the distal ends of the needle and cannula are positioned outside the hub body, with the needle holder returning to the retracted position and the cannula holder remaining in the insertion position. Furthermore, the movement of a portion of the hub body is configured to release the connection between the cannula holder and the hub body, allowing the cannula holder to return to the retracted position.

[0007] The needle holder may include a passage configured to communicate fluidly with a fluid source, and the needle communicates fluidly with the passage in the needle holder. At least a portion of the needle may be received in a cannula, and the cannula holder may include a seal that engages with the needle. The needle hub may include a first projection, and the cannula holder may include a second projection, and when the cannula is in the insertion position, the first projection of the needle hub engages with the second projection of the cannula holder to restrict the movement of the cannula holder to the retracted position. The needle hub may include a release tab, and the movement of the release tab disengages the engagement between the first projection of the needle hub and the second projection of the cannula holder, allowing a cannula spring to bias the cannula to the retracted position. At least a portion of the release tab may be configured to engage with the skin surface of a person after the needle hub has been attached to a person.

[0008] The activation button may be movable along a first axis, and the needle holder and cannula holder may be movable along a second axis perpendicular to the first axis. The first operating surface of the activation button may be configured to disengage from the second operating surface of the needle holder after the activation button has moved a predetermined distance along the first axis.

[0009] 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 punctures the skin surface.

[0010] In one embodiment or aspect, a needle hub for a drug delivery device includes a hub body, an activation button movable relative to the hub body, a needle holder movable relative to the hub body, a needle attached to the needle holder, a cannula holder movable relative to the hub body and the needle holder, a cannula attached to the cannula holder, the cannula being configured to communicate fluidly with a fluid source, a drive spring configured to bias 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 distal ends of the needle and cannula are positioned outside the hub body, and a retraction spring configured to retract the needle holder from the inserted position to the retracted position. Before activation of the activation button, the drive spring engages with the cannula holder, and the needle holder engages with the cannula holder to prevent movement of the cannula holder. After the activation button is pressed, the needle holder moves relative to the hub body, allowing the cannula holder to rotate relative to the needle holder, and as a result, the drive spring is configured to move the cannula holder and needle holder to the insertion position.

[0011] The hub body may include a first cam surface, and the cannula holder may include a second cam surface, and the engagement of the second cam surface with the first cam surface is configured to rotate the cannula holder. The needle holder may include a first projection, and the cannula holder may include a second projection, and before the activation button is activated, the first projection of the needle holder engages with the second projection of the cannula holder to prevent rotation of the cannula holder. The activation button may be configured to be pressed down, and pressing the activation button moves the first projection of the needle holder out of engagement with the second projection of the cannula holder, allowing the cannula holder to rotate, the first cam surface of the hub body to disengage from the second cam surface of the cannula holder, and the cannula holder and needle holder to move to the insertion position. After activation of the activation button and rotation of the cannula holder, the first drive surface of the cannula holder may engage with the second drive surface of the needle holder, and as a result, the movement of the cannula holder toward the insertion position will also move the needle holder toward the insertion position. After the cannula holder has moved toward the insertion position, the needle holder engages with the inclined portion of the hub body and rotates the needle holder, and as a result, the first drive surface of the cannula holder disengages from the second drive surface of the needle holder, allowing the retraction spring to bias the needle holder toward the retracted position. The activation button may be movable from a first position to a second position, and when the activation button is in the first position, the activation button is restricted from being pressed down.

[0012] The needle hub may further include a needle shield covering at least a portion of the needle and cannula, and a needle shield removal device engaging with the hub body, the needle shield removal device preventing movement of the activation button. With the needle holder in the retracted position and the cannula holder in the insertion position, the needle may be positioned entirely outside the cannula. The cannula holder may include an inlet configured to communicate with a fluid source, and the cannula holder includes a seal engaging with the needle. The drive springs may be first and second compression springs.

[0013] The above and other features and advantages of the present disclosure, and the manner in which they are achieved, will become more apparent by reference to the following description of embodiments of the present disclosure, taken in conjunction with the accompanying drawings, and the present disclosure itself will be better understood.

Brief Description of the Drawings

[0014] [Figure 1] It is a schematic diagram of a drug delivery device according to one aspect or embodiment of the present application. [Figure 2] It is a schematic diagram of the drug delivery device of FIG. 1. [Figure 3] It is a perspective view of a needle hub according to one aspect or embodiment of the present application. [Figure 4A] It is a top view of the needle hub of FIG. 3 showing the indicator before use of the needle hub. [Figure 4B] It is a top view of the needle hub of FIG. 3 showing the indicator after insertion of the needle. [Figure 4C] It is a top view of the needle hub of FIG. 3 showing the indicator after withdrawal of the cannula. [Figure 5] It is a schematic diagram showing the method of using the needle hub of FIG. 3. [Figure 6A] It is a schematic diagram of the needle hub of FIG. 3 showing the operation of the activation button. [Figure 6B] It is a schematic diagram 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] It is a schematic diagram of the needle hub of FIG. 3 showing the needle in the retracted position and the cannula in the inserted position. [Figure 6D] It is a schematic diagram of the needle hub of FIG. 3 showing the movement of the cannula to the retracted position. <00​​​​​​​​​​A perspective view of a needle hub according to a further aspect or embodiment of the present application. [Figure 11] A schematic diagram showing a method of using the needle hub of FIG. 7. [Figure 12A] A schematic diagram of the needle hub of FIG. 7 showing the position before use of the needle hub. [Figure 12B] A schematic diagram of the needle hub of FIG. 7 showing the actuated needle hub. [Figure 12C] A schematic diagram of the needle hub of FIG. 7 showing the retracted needle. [Figure 12D] A schematic diagram of the needle hub of FIG. 7 showing the needle in the retracted position. [Figure 12E] A schematic diagram of the needle hub of FIG. 7 showing the applicator removed from the needle hub. [Figure 12F] A schematic diagram of the needle hub of FIG. 7 showing the cannula in the retracted position. [Figure 13] A cross-sectional view of a needle hub according to a further aspect or embodiment of the present application. [Figure 14] A cross-sectional view of the needle hub of FIG. 13. [Figure 15] A perspective view of a needle hub according to a further aspect or embodiment of the present application. [Figure 16] A perspective view of a needle hub according to a further aspect or embodiment of the present application. [Figure 17] A perspective view of a needle actuation assembly according to an aspect or embodiment of the present application. [Figure 18A] A cross-sectional view of the needle hub of FIG. 15 showing the insertion position of the cannula. [Figure 18B] A cross-sectional view of the needle hub of FIG. 15 showing the retracted position of the cannula. [Figure 19] A perspective view of a needle hub according to a further aspect or embodiment of the present application. [Figure 20] A schematic diagram showing a method of using the needle hub of FIG. 19. [Figure 21] A perspective view of a needle actuation assembly according to a further aspect or embodiment of the present application. [Figure 22]This 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 22 is an exploded perspective view of the drug delivery device and needle hub. [Figure 24] Figure 22 is a perspective view of the drug delivery device and needle hub, showing the connected drug delivery device and needle hub during drug delivery. [Figure 25] Figure 22 is a perspective view of the drug delivery device and needle hub, showing the needle hub separated from the drug delivery device during drug delivery. [Figure 26A] This 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 26B] This is a cross-sectional view of a needle hub according to a further aspect or embodiment of the present application, showing engagement with a skin surface. [Figure 26C] This 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 27A] This 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] This is a cross-sectional view of a needle hub according to a further aspect or embodiment of the present application, showing engagement with a skin surface. [Figure 27C] This 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] This 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] This is a cross-sectional view of a needle hub according to a further aspect or embodiment of the present application, showing engagement with a skin surface. [Figure 28C] This 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] This is a perspective view of a needle actuation assembly according to a further aspect or embodiment of the present application, showing a non-actuated position. [Figure 30] Figure 29 is a perspective view of the needle operating assembly, showing the operating position. [Figure 31] Figure 29 is a cross-sectional view of the needle operating assembly showing the non-operating position. [Figure 32] Figure 29 is a cross-sectional view of the needle operating assembly, showing the operating position. [Figure 33] Figure 29 is a cross-sectional view of the needle actuation assembly showing the retracted position. [Figure 34] This is a perspective view of a needle hub according to a further aspect or embodiment of the present application. [Figure 35] Figure 34 is a schematic diagram of the needle hub. [Figure 36] This is a perspective view of a drug delivery device according to further aspects or embodiments of this application. [Figure 37] Figure 36 is a front view of the drug delivery device. [Figure 38] Figure 36 is a front view of the drug delivery device, showing the reservoir separated from the drug delivery device. [Figure 39] Figure 36 is a front view of the drug delivery device attached to the patient. [Figure 40] This is a partial cross-sectional view of a conventional valve assembly. [Figure 41] This is a front cross-sectional view of a needle hub for a drug delivery device according to a further aspect or embodiment of the present application. [Figure 42] Figure 41 is a cutaway perspective view of the needle hub. [Figure 43] Figure 41 is a cutaway perspective view of the needle hub, showing the needle shield removal device. [Figure 44] Figure 41 is a side cross-sectional view of the needle hub, showing its position before use. [Figure 45] Figure 41 is a side cross-sectional view of the needle hub, showing the needle shield removal device removed from the needle hub. [Figure 46] Figure 41 is a side cross-sectional view of the needle hub, showing the initial operation of the power button. [Figure 47] This is a partial perspective view of the needle hub of Figure 41, showing a start button according to one aspect or embodiment of the present application. [Figure 48]Figure 41 is a partial perspective view of the needle hub, showing the retracted position of the needle holder and cannula holder. [Figure 49] Figure 41 is a side cross-sectional view of the needle hub, showing that the power button has been pressed. [Figure 50] Figure 41 is a partial perspective view of the needle hub, showing that the power button has been pressed. [Figure 51] Figure 41 is a side cross-sectional view of the needle hub, showing the needle holder and cannula holder in the insertion position. [Figure 52] Figure 41 is a partial perspective view of the needle hub, showing the first rotation of the needle holder. [Figure 53] Figure 41 is a partial perspective view of the needle hub, showing the final rotation of the needle holder. [Figure 54] Figure 41 is a side cross-sectional view of the needle hub, showing the needle holder in the retracted position and the cannula holder in the insertion position. [Figure 55] Figure 54 is an enlarged perspective view of the region shown. [Modes for carrying out the invention]

[0015] Corresponding reference letters indicate the corresponding parts through several figures. The examples described herein illustrate exemplary embodiments of the disclosure, and such examples should not be construed as limiting the scope of the disclosure.

[0016] Detailed description of the invention Spatial or directional terms such as "left," "right," "inside," "outside," "up," and "down" should not be interpreted as limiting, as the present invention may envision various alternative orientations.

[0017] All figures used herein and in the claims should be understood, in all examples, to be modified 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” include plural references unless the context clearly specifies otherwise. “First,” “second,” and similar terms are not intended to refer to a particular order or time sequence, but rather to different conditions, characteristics, or elements. “At least” means “more than or equal to.”

[0018] Referring to Figures 1-3, the drug delivery device 10 includes a reservoir 12, a power module 14, an insertion mechanism 16, a control electronics unit 18, and a housing 20. In one aspect or embodiment, the drug delivery device 10 is a wearable automatic syringe. The drug delivery device 10 is attached to the patient's skin and can be triggered 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 it may be filled with a pharmaceutical composition by the patient or a medical professional before use. The control electronics unit 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 mechanism.

[0019] The drug delivery device 10 is configured to deliver a certain dose of a pharmaceutical composition, such as any desired drug, into the patient's body by subcutaneous injection at a slow, controlled injection rate. The exemplary time for 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 amount of pharmaceutical composition delivered to the patient can be adjusted. The drug delivery device 10 may communicate with another device, such as a mobile device or a computer.

[0020] 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 withdrawal tab 38. The needle hub 30 includes the indwelling cannula. The status indicator 36 may be white (Figure 4A) when not in use, blue (Figure 4B) when the needle is inserted and ready for injection, and green (Figure 4C) when the cannula has been withdrawn. As shown in Figure 5, the needle hub 30 is used by removing the package, 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 inside the patient. The drug or fluid is then injected into the patient. Once the injection is complete, the cannula withdrawal tab 38 is pulled, which retracts the cannula. The needle hub 30 can then be removed from the patient's skin.

[0021] Referring to Figures 6A-6D, in one embodiment, the needle hub 30 includes a hub body 42, an activation button 34, a needle holder 44, a needle 46 attached to the needle holder 44, a needle spring 48, a cannula holder 50, a cannula 52 attached to the cannula holder 50, and a cannula spring 54. The activation button 34 is movable relative to the hub body 42 and has a first operating surface 56. The needle holder 44 is movable relative to the hub body 42 and has a second operating surface 58. The first operating surface 56 of the activation button 34 is configured to engage with the second operating 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. A cannula spring 54 biases the cannula holder 50 to a retracted position where the cannula 52 is positioned within the hub body 42. Movement of the activation button 34 is configured such that the first operating surface 56 of the activation button 34 engages with the second operating 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 an insertion position where the distal ends of the needle 46 and cannula 52 are positioned outside the hub body 42, with the needle holder 44 returning to the retracted position while the cannula holder 50 remains in the insertion position. Movement of a portion of the hub body 42 is configured to disengage the cannula holder 50 from the hub body 42, allowing the cannula holder 50 to return to the retracted position.

[0022] 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 communicates fluidly 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 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 30 engages with the second projection 68 of the cannula holder 50, restricting the movement of the cannula holder 50 to the retracted position.

[0023] Referring to Figures 3-6D, the needle hub 30 includes a release tab 70, and the movement of the release tab 70 disengages the first projection 66 of the needle hub 30 from 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 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 activation 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 operating surface 56 of the activation button 34 is configured to disengage from the second operating surface 58 of the needle holder 44 after the activation button 34 has moved a predetermined distance along the first axis 72.

[0024] Referring to Figures 7-14, in a further embodiment or designation, 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 activation button 90, while the hub body 92 has 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 activation button 90 is configured to move the needle holder 84 and the cannula holder 94 from a retracted position, in which the needle 86 and cannula 96 are positioned within the applicator 82 or the hub body 92, to an insertion position, in which the distal ends of the needle 86 and cannula 96 are positioned 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 retraction spring 100 when the cannula holder 94 is moved from the retracted position to the insertion position. As shown in Figure 10, in one embodiment, the cannula withdrawal button 98 may be omitted.

[0025] Referring to Figures 12A-12F, the needle holder 84 is configured to move to a retracted position after moving to the insertion position of the cannula holder 94. The activation 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. Movement of the activation button 90 causes the drive projection 103 to engage with the needle holder 84, moving the needle holder 84 and the cannula holder 94 to the insertion position, and the drive projection 103 to engage 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 88 to return the needle holder 84 to the retracted position. The operation 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 secure 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 activation button 90 is received within 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.

[0026] Referring to Figure 11, in one aspect or embodiment, the needle hub 80 is used by removing the package, removing the adhesive liner, attaching the needle hub 80 to the patient's skin surface, removing the safety cap, and pressing the activation button 90 on the applicator 82, which automatically activates and retracts the needle 86 so that it leaves the indwelling cannula 96. The applicator 82 can then be removed from the hub body 92 and injection can be started. Once injection is complete, the cannula withdrawal button 98 is 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.

[0027] Referring to Figures 13 and 14, in one aspect or embodiment, the cannula holder 94 includes a portion of the adhesive pad 105, which removes the portion of the adhesive pad 105 from the patient's skin when the cannula holder 94 is removed from the hub body 92, facilitating the easy removal of the remaining portion of the adhesive pad 105 from the patient's skin.

[0028] Referring to Figures 15-18B, in further aspects or embodiments, the needle hub 112 includes a hub body 114, an activation button 116, a needle holder 118 and a needle 120 attached to the needle holder 118, a cannula holder 122 and a cannula 124 attached to the cannula holder 122, a needle actuation mechanism 126, and a cannula spring 128. The needle actuation mechanism 126 is configured to move the needle holder 118 and the cannula holder 122 from a retracted position to an insertion position, and is configured to retract the needle holder 118 to the retracted position. The needle actuation mechanism 126 includes a cam track 130, a cam member 132 housed 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-actuated 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.

[0029] Referring to Figures 17-18B, the hub body 114 includes a cannula lock 136 configured to lock the cannula holder 122 in the insertion position. 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 release tab 140. The movement of the release 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 away from the cannula holder 122 via a locking spring 142, and the hub body 114 includes a hinge portion 144, which is configured to rotate with the movement of the release tab 140 and move away from the cannula lock 135. The cannula holder 122 includes a port 146 configured to communicate fluidly with the fluid reservoir 12, and the cannula 124 communicates fluidly 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.

[0030] Referring to Figures 19-21, in a further aspect or embodiment, 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 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.

[0031] 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 has 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. The cam block 178 defines the cam track 172, and when the locking member 166 is in the second position, the cam block 178 extends through the opening 170 of the locking member 166. The needle actuation assembly 158 further includes a cannula 180, and when the needle holder 154 is in the retracted position, the needle 156 is received within the cannula 180.

[0032] 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 activation button. As shown in Figure 20, the needle hub 152 is used by removing the package, removing the adhesive liner, attaching the needle hub 152 to the patient's skin surface, and activating the drive mechanism 27 to insert the needle 156, which automatically retracts, leaving the indwelling cannula 180. After 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 results in a decrease in pressure of the pressure interlock 160, resulting in the cannula holder and / or the cannula 180 automatically retracting.

[0033] Next, 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. However, the drug delivery devices 190 and needle hubs 192 of Figures 22–25 are modular, and the needle hub 192 may be optionally integrated within 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 aspect, the drug delivery device 190 and needle hub 192 may remain connected or integrated for smaller drug volumes, and may be separated with a fluid connection between them for larger drug volumes.

[0034] Referring to Figures 26A-26C, a needle hub 200 with a skin tenting reduction structure is shown according to one aspect or embodiment. The needle hub 200 includes a rotational engagement mechanism 202, a portion of which initially 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 stretches the skin and reduces skin tenting.

[0035] Referring to Figures 27A-27C, a needle hub 204 with a skin tenting reduction structure is shown according to one aspect or embodiment. The needle hub 204 includes an adhesive ring 206 which is pressed against the skin prior to needle insertion when the activation button is pressed down or activated. The adhesive ring 206 stretches the skin to reduce skin tenting.

[0036] Referring to Figures 28A-28C, a needle hub 208 with a skin tenting reduction structure is shown according to one aspect or embodiment. 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 activation button 212 engages with the skin stretching member 210, causing it to move radially outward, which locally stretches the skin and reduces skin tenting.

[0037] The skin tenting reduction structures and related mechanisms shown in Figures 26A–28C may be incorporated into any of the embodiments or configurations of the needle hub or needle insertion configuration disclosed herein.

[0038] Referring to Figures 29-33, in one aspect or embodiment, the needle actuator assembly 220 includes a clip 222 that holds the needle actuator body 224 and the cannula body 226 in a retracted position, and the needle actuator body 224 and the cannula body 226 are biased by a spring 228. Pushing the clip 222 inward releases the needle actuator body 224 and the cannula body 226, resulting in 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 the inclined structure, resulting in the cannula body 226 rotating and / or retracting. The cannula body 226 is held in place by the clip 236 on the wall of the housing 233. After the cannula body 226 has rotated and / or retracted, the needle actuator body 224 is released and the return spring 238 retracts the needle 230.

[0039] Referring to Figures 34 and 35, in further aspects or embodiments, 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 drive mechanism 27 and a connecting arrangement 246 configured to place the needle hub 240 in fluid communication with the reservoir 12, a flow path 248, and an adhesive pad and / or adhesive layer 250. The connecting arrangement 246 may provide a sterile connection between the needle hub 240 and the reservoir 12. Needle retraction may be activated manually, via a trigger mechanism connected to the end of a drug delivery event, and / or via a wireless connection between the drive unit and the needle hub 240. The trigger mechanism may include a flexible-rigid connection to the movement of the plunger rod (fully or partially, at the end of the movement). The flow path 248 and the connecting arrangement 246 are kept sterile until a connection with the sterile subsystem and the reservoir 12 is established.

[0040] Referring to Figures 36-39, in further aspects or embodiments, the drug delivery device 252 includes a flexible reservoir 254, where at least a portion of the flexible reservoir 254 is positioned outside 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-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 flow path 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.

[0041] Referring to Figure 40, any of the above-described embodiments or drug delivery devices 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 flow path to the needle and / or cannula. The valve assembly 260 may be similar to and may operate similarly to the valve assembly shown and described in Patent Document 1.

[0042] Referring to Figures 41-54, in further embodiments or models, the needle hub 270 for a drug delivery device includes a hub body 272, a movable activation button 274 relative to the hub body 272, a movable needle holder 276 relative to the hub body 272, a needle 278 attached to the needle holder 276, a movable cannula holder 280 relative to the hub body 272 and the needle holder 276, and a cannula 282 attached to the cannula holder 280. Re 282 is configured to communicate fluidly with a supply source such as a reservoir 12, and the drive spring 284 is configured to bias the needle holder 276 and cannula holder 280 from a retracted position where the needle 278 and cannula 282 are located inside the hub body to an insertion position where the distal ends of the needle 278 and cannula 282 are located outside the hub body 272, and the retraction spring 286 is configured to retract the needle holder 276 from the insertion position to the retracted position. Before the activation button 274 is activated, the drive spring 284 engages with the cannula holder 280, and the needle holder 276 engages with the cannula holder 280 to prevent the cannula holder 280 from moving. After activation of the activation button 274, the needle holder 276 is configured to move relative to the hub body 272, allowing the cannula holder 280 to rotate relative to the needle holder 276, and as a result, the drive spring 284 moves the cannula holder 280 and the needle holder 276 to the insertion position. The hub body 272 includes a first cam surface 288, and the cannula holder 280 includes a second cam surface 290, and the engagement of the second cam surface 290 with the first cam surface 288 is configured to rotate the cannula holder 280. The cannula holder 280 includes an inlet 292 configured to communicate with a fluid source such as a fluid reservoir 12, and the cannula holder 280 includes a seal 294 engaged with the needle 278. The drive spring 284 includes first and second compression springs, but one or more drive springs 284 may be used.

[0043] Referring to Figure 48, the needle holder 276 includes a first projection 296, and the cannula holder 280 includes a second projection 298. Before the activation button 274 is activated, the first projection 296 of the needle holder 276 engages with the second projection 298 of the cannula to prevent rotation of the cannula holder 280.

[0044] Referring to Figures 49 and 50, the activation button 274 is configured to be pressed down. Pressing down the activation button 274 is configured to move the first projection 296 of the needle holder 276 out of engagement with the second projection 298 of the cannula holder 280, allowing the cannula holder 280 to rotate, and the first cam surface 288 of the hub body 272 is disengaged from the second cam surface 290 of the cannula holder 280, causing the cannula holder 280 and the needle holder 276 to move to the insertion position. After activation of the activation button 274 and rotation of the cannula holder 280, the first drive surface 302 of the cannula holder 280 engages with the second drive surface 304 of the needle holder 276, and as a result, the movement of the cannula holder 280 toward the insertion position will also move the needle holder 276 toward the insertion position.

[0045] Referring to Figures 51-53, after the cannula holder 280 moves to the insertion position, the needle holder 276 engages with the inclined portion 306 of the hub body 272, causing the needle holder 276 to rotate. As a result, the first drive surface 302 of the cannula holder 280 disengages from the second drive surface 304 of the needle holder 276, allowing the retraction spring 286 to bias the needle holder 276 back to its retracted position.

[0046] Referring to Figures 41-49, the activation button 274 is movable from a first position to a second position, and when the activation button 274 is in the first position, it is restricted from being pressed down. As shown in Figure 47, the activation button 274 or another part of the drug delivery device may include a biasing member 308 that provides resistance to the activation button 274 when it is moved from the first position to the second position.

[0047] Referring to Figures 41-44, the needle hub 270 includes a needle shield 310 that covers at least a portion of the needle 278 and cannula 282, and a needle shield removal device 312 that engages with the hub body 272. The needle shield removal device 312 prevents the activation button 274 from moving when the needle shield removal device 312 is engaged with the hub body 272.

[0048] Referring to Figure 54, with the needle holder 276 in the retracted position and the cannula holder 280 in the insertion position, the needle 278 is positioned completely outside the cannula 282. When the needle 278 is positioned completely outside the cannula 282, the fluid flow through the cannula 282 is maximized.

[0049] The present invention has been described in detail for illustrative purposes based on what is considered to be the most practical and preferred embodiment at present; however, such details are solely for that purpose, and the present invention is not limited to the disclosed embodiments, but rather intended to extend to modifications and equivalent configurations that fall within the spirit and scope of the appended claims. For example, it should be understood that, to the extent possible, the present invention intends that one or more features of any embodiment may be combined with one or more features of any other embodiment.

Claims

1. A needle hub for a drug delivery device, wherein the needle hub is The hub body and A movable start button on the hub body, A needle holder that is movable relative to the hub body, The needle attached to the aforementioned needle holder, A cannula holder that is movable relative to the hub body and the needle holder, A cannula attached to the cannula holder, wherein the cannula is configured to communicate with a fluid source, A drive spring is configured to bias the needle holder and the cannula holder from a retracted position where the needle and the cannula are positioned within the hub body to an insertion position where the distal ends of the needle and the cannula are positioned outside the hub body. The needle holder includes a retraction spring configured to retract it from the insertion position to the retracted position, Prior to the activation of the activation button, the drive spring engages with the cannula holder, and the needle holder engages with the cannula holder to restrict the movement of the cannula holder. A needle hub characterized in that, after activation of the activation button, the needle holder is configured to move relative to the hub body, and the cannula holder is configured to rotate relative to the needle holder, and as a result, the drive spring moves the cannula holder and the needle holder to the insertion position.

2. A needle hub according to claim 1, wherein the hub body comprises a first cam surface, and the cannula holder comprises a second cam surface, and the engagement of the second cam surface with the first cam surface is configured to rotate the cannula holder.

3. A needle hub according to claim 2, wherein the needle holder comprises a first projection, and the cannula holder comprises a second projection, and before the activation button is activated, the first projection of the needle holder engages with the second projection of the cannula holder to prevent the cannula holder from rotating.

4. A needle hub according to claim 3, wherein the activation button is configured to be pressed down, and pressing down the activation button moves the first projection of the needle holder out of engagement with the second projection of the cannula holder, thereby enabling the cannula holder to rotate, and the first cam surface of the hub body is disengaged from the second cam surface of the cannula holder, thereby moving the cannula holder and the needle holder to the insertion position.

5. A needle hub according to claim 4, wherein, after the activation of the activation button and the rotation of the cannula holder, the first drive surface of the cannula holder engages with the second drive surface of the needle holder, and as a result, the movement of the cannula holder toward the insertion position also moves the needle holder toward the insertion position.

6. A needle hub according to claim 5, characterized in that, after the cannula holder moves to the insertion position, the needle holder engages with the inclined portion of the hub body to rotate the needle holder, as a result the first drive surface of the cannula holder disengages from the second drive surface of the needle holder, and the retraction spring biases the needle holder to return to the retracted position.

7. A needle hub according to claim 4, wherein the activation button is movable from a first position to a second position, and when the activation button is in the first position, the activation button is restricted from being pressed down.

8. A needle hub according to claim 1, further comprising a needle shield covering at least a portion of the needle and the cannula, and a needle shield removal device engaged with the hub body, wherein the needle shield removal device prevents the movement of the activation button.

9. A needle hub according to claim 1, wherein, with the needle holder in the retracted position and the cannula holder in the insertion position, the needle is positioned completely outside the cannula.

10. A needle hub according to claim 9, wherein the cannula holder is provided with an inlet configured to communicate with a fluid source, and the cannula holder is provided with a seal that engages with the needle.

11. A needle hub according to claim 1, wherein the drive spring comprises a first and a second compression spring.

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