Patch assemblies configured to facilitate needle insertion into a patient and delivery of a medicament through the needle, and methods of making and using the same

Abstract

A patch assembly configured to facilitate insertion of a needle into a patient and delivery of a medicament through the needle can include a body to contact the patient and a button movably attached to the body along a first axis. A sled can be positioned within the body and configured to rotate relative to the body, and a needle can be secured to and extend below a lower surface of the sled. A needle guard can be movably attached to the body and configured to surround the needle. A needle guard biasing member can be positioned within the body and the needle guard and can extend along a second axis that is perpendicular to the first axis. Application of force to the button can be configured to move at least a portion of the needle beyond the body and begin insertion of the needle into the patient.

Description

Technical Field

[0001] The technology disclosed herein relates generally to drug delivery and / or needle insertion. More specifically, in one embodiment, the technology disclosed herein relates to a patch assembly configured to facilitate the insertion of a needle into a patient and / or the delivery of drugs via a needle. Background Technology

[0002] Parenteral drug therapy, administered via needle or cannula through the patient's skin, can be delivered in several ways to accommodate a range of dose volumes. The delivery method and dose volume depend on several factors, such as the target location, the volume and concentration of the drug product required.

[0003] The volume of the fluid affects the delivery method and delivery time. At the lower end of the volume range, small doses of 5 mL or less can typically be delivered by injection over a period of no more than 60 seconds. At the upper end of the volume range, infusion therapies can deliver doses of more than 30 mL over a period of several hours. For some therapies that are greater than 5 mL but less than those typically suitable for infusion, the dose may be administered manually by injection over a period of no more than 5 minutes or even longer using a larger volume container (e.g., a 20 mL container).

[0004] The above injections can be delivered in any of a variety of ways, such as using a hypodermic or subcutaneous needle, or by intramuscular injection. Alternatively, the above injections can be delivered subcutaneously using an intradermal cannula and infusion line attached to a container. Large doses of medication must be delivered at a controlled rate over a moderate time period. Current best practices require healthcare providers to use a manual process to deliver these, applying steady pressure to slowly deliver the dose over time periods of several minutes (e.g., 3 to 5 minutes or longer).

[0005] The types of manual administration described above can present several problems. For example, manual injection requires dexterity and control to maintain a constant, controlled injection rate. Manual injection also demands close attention from the healthcare provider and can be time-consuming, potentially reducing the efficiency of both the healthcare provider and the clinic where they work. The constant stress and manual manipulation can also cause discomfort for the healthcare provider, such as hand cramps.

[0006] Some standard delivery systems are bulky and involve or require contact with or attachment to the patient's skin via adhesives. Adhesive contact can be problematic for patients with severe skin conditions. Sometimes, patients mistakenly correlate the overall size of these standard systems with the amount of pain the system will cause. Summary of the Invention

[0007] There is a need for a compact and ergonomic delivery system capable of delivering viscous fluids or medications to patients over a set time period and / or at a constant flow rate. Such a system would minimize or eliminate adhesive skin contact for patients with severe skin conditions, and / or reduce or eliminate some patients' perceptions of the size of the delivery system in relation to the amount of pain it will cause. There is also a need for a device that will be automated or more automated to replace the current manual process, and a robust and reliable alternative for delivery.

[0008] The technology disclosed herein addresses the above and other needs.

[0009] In one aspect, the present disclosure relates to a patch assembly configured to facilitate needle insertion into a patient and / or drug delivery via the needle. The patch assembly may include: a body configured to contact a patient at or near a desired needle insertion site; and a button movably attached to the body along a first axis. The button may be biased to a non-engaged position. The patch assembly may include: a carriage positioned within the body and configured to rotate relative to the body; and a needle attached to a lower surface of the carriage and extending below the lower surface of the carriage. The needle may be configured to be fluidly connected to a cartridge containing a drug. A needle protector may be movably attached to the body and may be configured to surround the needle. A needle protector biasing member may be positioned within the body and the needle protector. The needle protector biasing member may extend along a second axis perpendicular to the first axis. Applying force to the button may be configured to move at least a portion of the needle beyond the body and initiate needle insertion into the patient.

[0010] In another aspect, the technology disclosed herein relates to a patch assembly configured to facilitate needle insertion into a patient and / or drug delivery via the needle. The patch assembly may include a body configured to contact the patient at or near a desired needle insertion site. The body may include a lower body and a cartridge. The cartridge may be movably attached to the lower body along an axis. The needle may be fixedly attached to a portion of the cartridge and may be configured to be fluidly connected to the drug-containing cartridge. A needle guard may be movably attached to the lower body and configured to be surrounded by the lower body. A needle guard biasing member may be positioned within and surrounded by the lower body, cartridge, and needle guard. The needle guard biasing member may extend along an axis. Applying a force to the cartridge may be configured to initiate movement of the needle relative to the lower body assembly and the needle guard.

[0011] In another aspect, the present disclosure relates to a patch assembly that may include a body configured to contact a patient at or near a desired needle insertion site. The body may include a lower body and a cartridge. The cartridge may be movably attached to the lower body along an axis. A needle may be fixedly attached to a portion of the cartridge and may be configured to be fluidly connected to the drug-containing cartridge. A needle guard may be movably attached to the lower body and configured to be surrounded by the lower body. A needle guard biasing member may be positioned within and surrounded by the lower body, cartridge, and needle guard. The needle guard biasing member may extend along an axis. Attached Figure Description

[0012] The following detailed description of the technology of this disclosure will be better understood when read in conjunction with the accompanying drawings, wherein the same numerals always represent the same elements. Various exemplary embodiments are shown in the drawings for the purpose of illustrating the technology of this disclosure. However, it should be understood that the technology of this disclosure is not limited to the precise arrangements and tools shown. In the drawings: Figure 1 This is a perspective view of a cartridge adapter according to an optional aspect of the technology disclosed herein; Figure 2 This is a perspective view of a flexible conduit according to an optional aspect of the present disclosure, the flexible conduit being attached at one end to Figure 1 The cartridge adapter shown is attached to a portion of the patch assembly at the opposite end; Figure 3 yes Figure 2 A partial exploded perspective view of the patch assembly shown in the middle section, showing the assembly before injection; Figure 4 yes Figure 3 Another partial exploded perspective view of the patch assembly shown; Figure 5 yes Figure 3 Another exploded perspective view of a portion of the patch assembly shown; Figure 6 It is along Figure 3 The line AA is intercepted Figure 3 The cross-sectional perspective view of the patch assembly shown, in which the button is shown in a first or biased position; Figure 7 yes Figure 3 A perspective view of certain portions of the patch assembly shown, in which the button is shown in a second or engaged position; Figure 8 It is along Figure 3 The line AA is intercepted Figure 3 The diagram shows a cross-sectional front view of a portion of the patch assembly, in which the needle extends from the bottom of the patch assembly and the needle guard is positioned within the patch assembly; Figure 9 It is along Figure 3 The line AA is intercepted Figure 3 Another cross-sectional front view of a portion of the patch assembly shown, in which the needle guard surrounds the needle and extends to the outside of the patch assembly; Figure 10 This is a partial exploded perspective view of a patch assembly according to an optional aspect of the present disclosure. Figure 11 yes Figure 10 The image shows a perspective view of the patch assembly, where some parts have been omitted for clarity; Figure 12 It is along Figure 10 The line AA is intercepted Figure 10 A front view of the cross-section of the patch assembly shown; Figure 13 It is along Figure 10 The line AA is intercepted Figure 11 The top view of the patch assembly is shown, in which the button is shown in a first or offset position; Figure 14 yes Figure 11 The top plan view of the patch assembly is shown, in which the button is shown in the second or engaged position; Figure 15 During the injection Figure 10 Bottom perspective view of the patch component type shown; Figure 16 After injection Figure 10 Bottom perspective view of the patch component type shown; Figure 17 This is a partial exploded perspective view of a patch assembly according to an optional aspect of the present disclosure. Figure 18 It is along Figure 17 The line AA is intercepted Figure 17 The cross-sectional front view of the patch assembly shown indicates that the needle guard is shown in the retracted position; and Figure 19 yes Figure 17 Partial cross-sectional view of some internal components of the patch assembly shown. Detailed Implementation

[0013] While systems, apparatus, and methods are described herein by way of examples and embodiments, those skilled in the art will recognize that the technology of this disclosure is not limited to the described embodiments or figures. Rather, the technology of this disclosure covers all modifications, equivalents, and alternatives falling within the spirit and scope of the appended claims. Features of any embodiment disclosed herein may be omitted or incorporated into another embodiment.

[0014] Any headings used herein are for organizational purposes only and are not intended to limit the scope of the specification or claims. As used herein, the word "may" is used in a permissive sense (i.e., meaning possible) rather than a mandatory sense (i.e., meaning must). Unless specifically stated herein, the terms "an" and "the" are not limited to a single element but should be understood to mean "at least one". Terms include the foregoing words, their derivatives, and words with similar meanings.

[0015] As used in this article, “and / or” means referring to either or both of the items separated by such terms. For example, the phrase “A and / or B” would mean A alone, B alone, or both A and B.

[0016] As used herein, “usually” means “in a general manner” in relation to the term being modified, as would be understood by one of ordinary skill in the art.

[0017] Directional phrases used herein, such as, for example but not limited to, top, bottom, left, right, upper, lower, front, back, near, far and their derivatives, relate to the orientation of the elements shown in the accompanying drawings and are not a limitation of the claims, unless expressly stated therein.

[0018] Now refer to the various accompanying drawings for details, in which the same reference numerals always denote the same parts. Figures 1 to 9 A patch assembly, generally designated 101, is shown as an optional aspect of the present disclosure. This assembly is configured to facilitate insertion of a needle 103 into a patient and / or delivery of medication via the needle 103 in an ergonomic and easily activated manner. As explained in detail below, once the patch assembly 101 is placed on and / or attached to the patient, it facilitates one-step insertion of the needle 103. The injection can be delivered in any of a variety of ways, such as subcutaneous, intradermal, or intramuscular injection.

[0019] The patch assembly 101 may optionally be removably and / or movably attached to a drive system or actuation assembly 26, which may be included in an injection aid 10 separate from and distinct from the patch assembly 101 (examples of which are shown in...). Figure 1 (Illustrated in and described in U.S. Provisional Patent Application No. 63 / 622,485, filed January 18, 2024, a copy of which is attached as Appendix A). For example, patch assembly 101 may be placed on and / or attached to a patient's skin, and injection aid 10 may be detached from or located away from the patient. In such embodiments, injection aid 10 and patch assembly 101 may be fluidly and / or operatively connected via flexible tubing 74 through which medication may flow.

[0020] The drive system 26 of the injection aid 10 can removably receive a syringe or cartridge 16 having a body containing a drug chamber 18 and aligned with or including a plunger 68. In an optional embodiment, this allows a relatively small patch to be attached to the patient while maintaining a powerful drive system to deliver relatively high-viscosity medications. Alternatively, the drive system of the injection aid 10 may have an integral container that is pre-filled or filled upon use.

[0021] like Figure 1 and Figure 2 As shown, the patch assembly 101 and / or its fluid pathway or an attachable fluid pathway may optionally include an adapter 94 configured to attach to a distal end or outlet end of the injection aid 10 and / or cartridge 16. The adapter 94 may be removably or permanently attached to the injection aid 10. The adapter 94 may also be permanently attached (e.g., by adhesive) to one end of a flexible tubing 74. The flexible tubing 74 is configured to fluidly connect a needle 103, optionally formed of steel, to a drug-containing cartridge 16.

[0022] The adapter 94 may optionally be in the form of or include an arcuate member 95, which ensures that at least one short, straight section of tubing 74 is always present for interaction with at least a portion of the injection aid 10. The arcuate member 95 replaces the Luer attachments or fittings of prior art adapters. One or more clips or arms 97 on the proximal end of the adapter 94 may be flexed to receive a portion of the cartridge 16 therein for fluidly connecting the cartridge 16 to the tubing 74. Optionally, the arm 97 may be configured to removably receive a 13 mm vial or cartridge. A needle 93, which may be surrounded by and / or spaced inwardly from the arm 97, may be configured to pierce the septum of the cartridge 16.

[0023] See Figure 3 , Figure 4 and Figure 6 The patch assembly 101 may include a body 111. The bottom or distal surface of the body 111 is configured to directly contact the patient's skin P at or near the desired needle insertion site. The bottom or distal surface of the body 111 may optionally include fasteners, such as adhesives, for temporary attachment or adhesion to the patient's skin. Optionally, the body 111 may include an upper body 111a and a lower body 111b, which may clip together or snap together.

[0024] like Figures 5 to 9As shown, the lower body 111b may include at least one or two spaced-apart and vertically extending channels 113 therein and / or on its inner surface. Optionally, the channels 113 are radially opposed in the lower body 111b. Flanges 113a may extend adjacent to each channel 113 within the lower body 111b. Each flange 113b may extend perpendicular to the corresponding channel 113. Optionally, each flange 113a may be a cut or horizontal recess formed at, in, or near the upper edge of the lower body 111b.

[0025] The lower body 111b may also include at least one or three or more evenly spaced and vertically extending slots 113b. The slots 113b may extend parallel to the channel 113 and perpendicular to the flat bottom surface of the lower body 111b. The lower body 111b may also include at least one or three or more evenly spaced holes 113c extending through its sidewalls. Each of the holes 113c may be spaced apart from or located above the bottom surface of the lower body 111b. Optionally, each of the channel 113, slots 113b, and holes 113c may be radially offset from each other.

[0026] In an optional implementation scheme, such as Figure 3 , Figure 4 , Figure 6 , Figure 8 and Figure 9 As shown, the cover 121 can be removably or fixedly attached to the upper body 111a. The cover 121 and the upper body 111a may define an upper body recess 123 therebetween. The upper body recess 123 may be configured to receive at least a portion therein of the flexible conduit 74. Optionally, as... Figure 3 As shown, the size, shape, and / or construction of the upper body recess 123 can be designed to receive excess flexible conduit 74 or annular slack of the flexible conduit. This excess or annular slack can be used to accommodate and / or allow movement of a portion of the patch assembly 101 relative to the body 111. For simplicity, Figure 8 and Figure 9 The annular residual tube is omitted in the text.

[0027] The patch assembly 101 in this embodiment may optionally be button-activated. However, other forms of actuation (such as direct user engagement of another part of the patch assembly 101) are possible. More specifically, see Figures 3 to 9 In the alternative embodiment shown, patch assembly 101 may include button 131, which is movably attached along the first axis A to body 111 and / or lower body 111b (see [reference]). Figure 4The first axis A optionally extends parallel to the flat bottom surface of the lower body 111b and parallel to the patient's skin P. Furthermore, the first axis A optionally extends perpendicular to the channel 113 of the lower body 111b.

[0028] Button 131 can be in a first or non-engaged position (e.g., see...) Figure 3 and Figure 6 ) and a second or engagement position (e.g., see Figures 7 to 9 The button 131 is movable between the two bodies. In the first or non-engaged position, at least a portion of the button 131 may extend radially outward beyond the body 111. In the second or engaged position, the entire button 131 may be positioned within the outer periphery of the body 111.

[0029] like Figure 4 , Figure 5 and Figure 7 As shown, button 131 may optionally include at least one or two spaced-apart arms 133 extending from base 134. The arms 133 may be spaced apart in a direction perpendicular to the first axis A. The first arm 133a of the two spaced-apart arms 133 may be at least slightly longer than the second arm 133b of the two spaced-apart arms 133. The distal end of the first arm 133a may be in the form of a pusher or a blunt surface, configured to engage in a slot or groove 115 formed in the body 111 and / or lower body 111b (see...). Figure 5 and Figure 7 )Inside.

[0030] Optionally, a button biasing member 135, which may be in the form of a helical spring, may be positioned between the base 134 of the button 131 and a portion of the body 111. The button biasing member 135 may be positioned between a first arm 133a and a second arm 133b and may extend along a first axis A. The button biasing member 135 may be configured to bias the button 131 to a non-engaged position. The spring force of the button biasing member 135 can be relatively easily overcome by a user or healthcare professional pressing the button 131 with his / her finger or thumb.

[0031] See Figure 2 , Figure 4 and Figures 6 to 9 In an optional embodiment, patch assembly 101 may include a carriage 141 positioned within body 111. The carriage 141, which may be generally cylindrical in form, may be configured to rotate and translate relative to body 111 along a second axis B (see [link to relevant documentation]). Figure 5 The second axis B can be perpendicular to the first axis A. The end of the flexible conduit 74 opposite to the adapter 94 can be fixedly attached (e.g., by bonding) to the carriage 141 along the second axis B. Thus, the carriage 141 can be movable relative to the body 111 and fixedly attached to the end of the flexible conduit 74.

[0032] like Figure 2 , Figure 6 , Figure 8 and Figure 9 As shown, needle 103 can be secured to slide 141 and can extend outward from slide along a second axis B. Optionally, needle 103 extends perpendicular to the flat bottom surface of slide 141. When slide 141 is placed within body 111, at least a portion of needle 103 extends below the lower or bottom surface of slide 141, and at least a portion of needle 103 is surrounded by slide 141. As explained in detail below, rotation of slide 141 allows needle 103 to be inserted into the patient.

[0033] A firing biasing member 145 (such as a helical spring) may surround at least a portion of the flexible conduit 74 within the body 111 at or near the carriage 141. The firing biasing member 145 may extend along the second axis B and be positioned within the body 111. In an optional embodiment, one end of the firing biasing member 145 is attached to or contacts the carriage 141, and the opposite end of the firing biasing member 145 may contact the inner surface of the upper body 111a.

[0034] The carriage 141 may include at least one or two spaced tabs 143 extending outward from its generally arcuate sidewalls. Optionally, the tabs 143 may be radially opposed and located at or near the top surface of the carriage 141. Each tab 143 may be configured to engage by a pusher of the first arm 133a of the button 131 through a slot 115, which allows the carriage 141 to rotate within the body 111. Before engaging the button 131, each tab 143 may also rest on and / or engage a flange 113a of the lower body 111b. The size, shape, and / or configuration of each tab 143 may be designed such that after the button 131 is engaged, each tab 143 engages within and / or moves within (e.g., is confined by) one of the channels 113 of the lower body 111b.

[0035] In an optional implementation scheme, such as Figures 4 to 9 As shown, the patch assembly 101 may include a needle protector 151 movably attached to the body 111 and / or the lower body 111b. More specifically, the needle protector 151 may optionally be movable along a second axis B (see [reference]). Figure 5 The needle protector 151 is configured to automatically surround the needle 103, such as after medication has been delivered into the patient, to protect the patient and others from harm by the needle 103.

[0036] Needle protector 151 may include at least one or more spaced-apart tabs 153 (see Figure 5The figure shows three spaced-apart tabs 153, but more or fewer tabs 153 are possible. Each of the tabs 153 may extend outward from the outer surface of the sidewall of the needle protector 151. Optionally, each tab 153 is fixed relative to and integrally formed with the sidewall of the needle protector 151.

[0037] Figure 5 At least one or more spaced-apart retaining clips 157 are also shown, optionally included in or formed in the sidewall of the needle protector 151. Each clip 157 may be radially spaced from each tab 153. Each of the plurality of clips 157 is flexible relative to the remainder of the needle protector 151 compared to the tab 153. Each of the clips 157 includes a portion biased in an initial position to extend radially outward beyond the sidewall of the needle protector 157, and each clip 157 is configured to flex at least slightly inward when the needle protector 151 is inserted into the lower body 111b. Each of the clips 157 may be configured to flex at least slightly outward once the needle protector 151 is inserted into the lower body 111b to retain the needle protector 151 within the lower body 111b.

[0038] For assembling the patch assembly 101, the needle protector 151 can be inserted into the bottom of the lower body 111b along the second axis B. As the needle protector 151 is inserted into the lower body 111b from below and moves into the interior of the lower body 111b, each of the tabs 153 can be received by one of the plurality of spaced slots 113b of the lower body 111b. Optionally, once the tab 153 is located at or in the corresponding slot 113b, the needle protector 151 cannot be easily removed from the lower body 111b. Furthermore, as the needle protector 151 is axially pushed along the second axis B, the clips 157 can simultaneously flex inward (e.g., perpendicular to the second axis B) (e.g., using an assembly tool or other securing device) until each clip 157 reaches and partially extends into one of the openings 113c. This combination of steps positions the needle protector 151 in a retracted position (e.g., see...). Figure 6 and Figure 8 ).

[0039] like Figure 4 , Figure 6 , Figure 8 and Figure 9As shown, the patch assembly 101 may include a needle guard biasing member 161, optionally in the form of a helical spring, positioned within the body 111, upper body 111a, lower body 111b, and / or needle guard 151. The needle guard biasing member 161 may extend along a second axis B. Optionally, the needle guard biasing member 161 is larger, wider, and / or generates a stronger spring force than the firing biasing member 145, and the two biasing members 161, 145 are separated within the body 111 by a carriage 141, as... Figure 8 and Figure 9 As shown.

[0040] In operation, applying force to button 131 (e.g., directly parallel to the patient's skin P) moves at least a portion of needle 103 beyond body 111 and initiates insertion of needle 103 into the patient's body. More specifically, triggering of needle 103 and / or carriage 141 is achieved by a rotating mechanism about a second axis B. In the prior art, triggering is typically achieved by deflection of clips. However, a disadvantage of deflecting clips is that they are typically subjected to loads during storage, making them more prone to creep and accidental release.

[0041] In the initial state or non-triggered state, such as Figure 6 As shown, the carriage 141 is under the compression spring force provided by the firing bias member 145. At this time, through the flange 113a resting on the lower body 111b (for example, see...), Figure 7 The tab 143 on the slide 141 restricts its movement or rotation. The slide 141 is biased to rotate counterclockwise or away from the channel 113. The needle guard 151 is also under the compression spring force generated by the larger diameter needle guard biasing member 161. In this state, the clip 157 (see, for example, Figure 5 This holds the needle protector 151 in place. Therefore, the force overcoming the clip 157 is greater than the initial spring force of the needle protector biasing member 161.

[0042] like Figure 7 and Figure 8 As shown, pushing button 131 inward and / or along the first axis A applies a small rotation (e.g., 10 to 20 degrees) to carriage 141 relative to body 111 via the actuator of the first arm 133a of button 131. This has the effect of causing each tab 141 to slide or rotate clockwise into one of the channel 113 cutouts in the lower body 111b from flange 133a toward the lower body 111b.

[0043] When the compression spring force is applied to the carriage 141 by the firing bias member 145, the carriage 141 is pushed downward along the second axis B to the end stop, which sets the depth of the needle 103. The carriage 141 also compresses the needle guard bias member 161 (e.g., compared to...). Figure 6 and Figure 8 This causes the compressive force applied to the needle protector 151 by the needle protector biasing member 161 to now increase to the extent that the spring force is greater than the force generated by the clip 157 abutting against the lower body 111b and / or within the opening 113c. However, at this stage, the needle protector 151 does not unfold and cannot unfold or extend outward beyond the lower body 111b, because the needle protector 151 remains against the patient's skin P.

[0044] When the patch assembly 101 is removed or detached from the injection site, the force applied by the needle guard biasing member 161 overcomes the force of the clip 157 against the lower body 111b and / or within the opening 113c, and the needle guard 151 is pushed by the needle guard biasing member 161 to move to its fully extended state (see...). Figure 9 The fully extended state extends beyond the lower body 111b. In this state, the clip 157 has moved below the locking flange inside the lower body 111b, which prevents the needle protector 151 from being pushed back into the lower body 111b.

[0045] Optionally, the fluid path may include or consist of an adapter 94, a flexible conduit 74, a firing bias member 145, a carriage 141, and a pin 103. The fluid path may be a separate, self-contained sub-assembly of the patch assembly 101. In such optional embodiments, the fluid path may be integrated into the remaining components of the patch assembly 101.

[0046] The patch assembly 101 may optionally have a diameter of 1,835 mm. 2 The adhesive area is 13.3 grams. In another optional embodiment, the adhesive area can be between 1500 mm². 2 -2500mm 2 The weight can be between 12 grams and 14 grams.

[0047] Figures 10 to 16 Another optional aspect of the technology disclosed herein is shown. Figures 10 to 16 The patch assembly 201 shown has a similar design to Figures 1 to 9 Many components shown are similar to or the same as the patch assembly 101 discussed above. Therefore, Figures 1 to 9 The patch assembly 101 and Figures 10 to 16 Similar or identical structures between patch assemblies 201 can be Figures 10 to 16 China through comparison Figures 1 to 9 The figure references in the accompanying drawings are distinguished by the reference numerals larger than 100 (100). For convenience and brevity only, these references may be omitted in this document. Figures 1 to 9 Components and Figures 10 to 16 A description of certain similarities between the components.

[0048] Similar to the design described above, the patch component 201 can be button-activated. However, Figures 10 to 16 The distinguishing feature of the patch assembly 201 shown is that each arm of the button 231 may include a button clip 237a surrounded by a groove 237b formed in the respective arm 233a, 233b. Figure 11 (Only one is visible in the image). Each button clip 237a may be flexible and / or resilient. For example, at least a portion of each button clip 237a may be configured to engage an opening or groove 237b on the inner surface of the lower body 211b when the button 231 is properly attached to the lower body 211b using the button biasing member 235 therebetween. This opening or groove may optionally include an angled or ramped portion. The interaction between each button clip 237a and the corresponding groove 237b of the lower body 211b may provide slight stop when the button 231 is actuated, and / or prevent the button biasing member 235 from pushing the button 231 too far out of the lower body 211b.

[0049] A button biasing member 235 may surround at least a portion of the button 231, such as a protrusion extending inward from the base 234 between the two arms 233a, 233b. This aspect is also unique due to the visual indicator located on or within the body 211. Specifically, the visual indicator may optionally be a window or opening extending through a portion of the upper body 211a to visually indicate the lateral position of the button 231. For example, the button 231 may include two or more colors (e.g., yellow and green) or include symbols thereon, which may be visible through the window or opening depending on the lateral position of the button 231 relative to the body 211. The visual indicator allows a user or healthcare professional to distinguish between a device ready for use (e.g., yellow and button 231 not pressed) and a device in use (e.g., green and button 231 pressed). Printed icons may be used in place of different colors or in addition to different colors.

[0050] For assembly of the patch assembly 201, before or after the button biasing member 235 and button 231 are properly attached to the lower body 211b, at least a portion of the carriage 241 and / or fluid path may be placed in the needle protector 251 and the lower body 211b. The carriage 241 may be oriented such that each tab 243 rests on an inner flange 213a of the lower body 211b adjacent to one of the channels 213. A portion of the flexible conduit 74 may be fed through a slot in the upper body 211a, and the firing biasing member 245 may be positioned below the upper body 211a and above the carriage 241 along a second axis B. The upper body 211a may be pressed against and engaged with the lower body 211b to enclose the component therein. The flexible conduit 74 may extend out of the body 211 through an outlet hole formed between the upper body 211a and the lower body 211b. Then, the cover 221 can be pressed against and engaged with the upper body 211a, while ensuring that the annular excess or excess flexible tubing of the flexible conduit 74 is positioned within the recess 223 of the upper body (see [link]). Figure 12 ).

[0051] like Figure 15 and Figure 16 As shown, Figures 10 to 16 Another distinguishing feature of the patch assembly 201 shown is that the needle guard 251 can optionally pivot relative to the body 211. The needle guard 251 can be in a first or recessed position (see...). Figure 15 ) and a second or exposed location (see, for example, Figure 16 The needle 203 can pivot between the two. In the first or recessed position, the flat or planar bottom of the needle protector 251 may be coplanar with the flat or planar bottom of the lower body 211b, and at least a portion of the needle 203 may extend outward beyond the bottom of the needle protector 251. In the second or exposed position, the flat or planar bottom may extend relative to the flat or planar bottom of the lower body 211b at any of a variety of angles.

[0052] A pivot point 251a on one side of the needle protector 250 can be used as a position for the needle protector 251 to rotate around it. This pivot point can be or includes a stainless steel locating pin optionally having a diameter of 0.2 mm. One or a pair of clips extending from the body of the needle protector 251 can engage with a portion of the lower body 211b via a snap-fit ​​or otherwise engage.

[0053] Optionally, the bottom surface of the needle protector 251 may include an adhesive patch. When the needle 203 is inserted and the patch assembly 201 is removed from the injection site, the needle protector 251 can pivot outwardly away from the lower body 211b. The needle protector 251 may include at least one locking guard 251b opposite the pivot point 251a (see [link to relevant documentation]). Figure 16This prevents the needle protector 251 from pivoting before the button 231 is pressed. One advantage of this pivoting design is that the needle protector 251 is springless (i.e., the needle protector bias member 261 can be omitted), and therefore no force is applied to the injection site during infusion.

[0054] The patch assembly 201 may optionally have a 3,565mm diameter. 2 The adhesive area is 23.7 grams. In another optional embodiment, the adhesive area can be between 2,000 mm². 2 -4,000mm 2 The weight can be between 22 grams and 25 grams.

[0055] Figures 17 to 19 Another optional aspect of the patch assembly 301 of the present disclosure is shown. Figure 17 and Figure 18 The patch assembly 301 shown has a similar design to Figures 1 to 9 Many components shown are similar to or the same as the patch assembly 101 discussed above. Therefore, Figures 1 to 9 The patch assembly 101 and Figures 10 to 16 Similar or identical structures between patch assemblies 201 can be Figures 10 to 16 China through comparison Figures 1 to 9 The figure references in the accompanying drawings are distinguished by the reference numerals larger than 100 (200). For convenience and brevity only, these references may be omitted in this document. Figures 1 to 9 The patch assembly 101 and Figure 17 and Figure 18 Description of certain similarities between patch components 202.

[0056] like Figure 17 and Figure 18 As shown, the upper body 311a may include a body cover 314a and a body upper portion 314b. The upper body 311a may also be referred to herein as a "slide". At least a portion of the body cover 314a may extend into an internal cavity defined by the body upper portion 314b, and includes a helical ramp 314c thereon (see...). Figure 19 The main body cover 314a can be attached to the upper body 314b in any of a variety of ways, such as one or more mechanical fasteners, snap-fit, adhesive bonding, ultrasonic welding, etc. The lower body 311b may include a lower body portion 317a and a body interior 317b. At least a portion of the body interior 317b extends into the internal cavity defined by the lower body portion 317a. The lower body 311b can be attached to the lower body portion 317a in any of a variety of ways, such as one or more mechanical fasteners, snap-fit, adhesive bonding, ultrasonic welding, etc.

[0057] In an optional variant, such as Figure 17 and Figure 18 As shown, the upper body portion 311b of the upper body 314a may include at least one or more evenly spaced clips or protrusions 371 extending downward therefrom. The lower body portion 317a of the lower body 311b may include at least one or more evenly spaced corresponding pawls 381 or openings extending through the upper sidewall of the lower body portion 317a. Each pawl 381 may include an angled or inclined portion and may be configured to receive at least a portion of one of a plurality of spaced clips 371 that attach the upper body portion 314b to the lower body portion 317a. Of course, with certain modifications known to those skilled in the art, the positions of the clips 371 and pawls 381 may be reversed or flipped between the upper body portion 314b and the lower body portion 317b.

[0058] The needle protector 351 may include a plurality of spaced-apart and outwardly extending tabs 353. Each of the tabs 353 may be received and / or supported by one of a plurality of flanges 383 on the inner surface of the body interior 317b. A needle protector biasing member 361 may be located within the central cylinder of the needle protector 351 and may extend along a second axis B. Figure 19 As shown, the inner surface of the needle protector 351 may also include a spiral ramp 314d, which is complementary to the spiral ramp 314c of the main cover 314a.

[0059] Figure 17 and Figure 18 A distinguishing feature of the alternative embodiment of the patch assembly 301 shown is that, during operation, the upper body 311a is movably attached to the lower body 311b, such as along a second axis B. This movement can result in needle insertion into the patient. Therefore, optionally, the patch assembly 301 is manually activated by engaging the upper body 311a directly toward or against the patient, rather than by a button in a direction parallel to the patient's skin. Axial vertical downward movement on the upper body 311a directly drives the needle 303 into the injection site, which also applies rotation in the needle protector 351, effectively releasing the needle protector 251 from the lower body 311b. However, other forms of activation are possible, such as button activation.

[0060] The fluid path may include, or be composed of, flexible conduit 74, body cap 314a, and needle 303. Figure 18 As shown, the fluid path may include fixed or rigid bends, such as bends of exactly or approximately 90 degrees, which are integrated into the upper body 311a and / or body cover 314a. No firing bias member is used, and annular stubs of the flexible conduit 74 are not required to accommodate movement of a portion of the flexible conduit 74.

[0061] In operation, a force is applied to or onto the upper body 311a (e.g., downward or toward the patient's skin) to move at least a portion of the needle 303 beyond the body 311 and to initiate insertion of the needle 303 into the patient's body. Specifically, the needle protector 351 is configured to rotate relative to the lower body 311b. This rotation allows the needle protector 351 to translate or move relative to the lower body 311b along a second axis B. Thus, a manual push on the upper body 311a moves the needle 303 into the patient's body on the injection side. This manual push also applies rotation to the needle protector 351, which has the effect of releasing the needle protector 351 from the body 311.

[0062] Sufficient downward force is applied to the upper body 311a to overcome the force generated by the retaining clip extending outward from the needle protector 351. This action releases the needle protector 351 from within the lower body 311b. The inner core of the upper body 311a and / or a portion of the body cover 314a may include a helical ramp 314c that interacts with a corresponding helical ramp 314d on the inner surface of the needle protector 351. Axial movement of the upper body 311a induces rotation within the needle protector 351. This has the effect of causing the tabs of the needle protector 351 to slide from the corresponding flange of the inner body 317b and into the corresponding vertical channel within the inner body 317b.

[0063] Throughout the entire depth of needle 303 travel, the upper body 311a is locked to the lower body 311b by means of the same or similar means (such as a retaining clip) as explained in previous versions. Therefore, the patch assembly 301 cannot be easily reset after use. Simultaneously, the needle protector biasing member 361 applies a force that will extend the needle protector 351. However, at this stage, the needle protector 351 does not unfold because it remains against the patient's skin. When the patch assembly 301 is removed from the injection site; the needle protector 351 is pushed by the needle protector biasing member 361 to move to its fully extended state, which is at least partially below or beyond the lower body 311b. The needle protector 351 can be locked in the same or similar manner as in previous types, such as by using flexible clips on the needle protector 351 to optionally lock it in three different positions below the flange on the lower body 311b.

[0064] The patch assembly 301 may optionally have a diameter of 3,660 mm. 2 The adhesive area is 16.1 grams. In another optional embodiment, the adhesive area can be between 2,000 mm². 2 -4,000mm 2 The weight can be between 15 grams and 18 grams.

[0065] The following exemplary embodiments further describe optional aspects of the technology of this disclosure and are part of the detailed description. These exemplary embodiments are set forth in a format substantially similar to the claims (each embodiment has a numerical designation followed by a capital letter), although they are not technically claims of this patent application. The following exemplary embodiments are referred to in the dependent relation as “implementation” rather than “claims”.

[0066] 1A. A patch assembly configured to facilitate the insertion of a needle into a patient and the delivery of medication through the needle, the patch assembly comprising: main body; A button, which is movably attached to or located within the body; A carriage, the carriage being positioned within the body and configured to rotate relative to the body; The needle is fixed to the carriage; A needle protector, which is movably attached to the body; and A needle guard biasing component, wherein the needle guard biasing component is positioned within the main body and the needle guard. Applying force to the button is configured to move at least a portion of the needle beyond the body and begin inserting the needle into the patient.

[0067] 2A. The patch assembly according to embodiment 1A, wherein the body is configured to contact the patient at or near a desired needle insertion site on the patient.

[0068] 3A. The patch assembly according to embodiment 1A or 2A, wherein the button is movable relative to the body along a first axis and the button is biased to a non-engaged position.

[0069] 4A. The patch assembly according to any one of embodiments 1A to 3A, wherein the needle extends below the lower surface of the carriage and is configured to be fluidly connected to a cartridge containing a drug.

[0070] 5A. The patch assembly according to any one of embodiments 1A to 4A, wherein the needle protector is configured to surround the needle.

[0071] 6A. The patch assembly according to any one of embodiments 1A to 5A, wherein the needle protector is configured to surround the needle.

[0072] 7A. The patch assembly according to any one of embodiments 1A to 6A, wherein the needle guard biasing member extends along a second axis, the second axis extending perpendicular to the first axis.

[0073] 1B. A patch assembly configured to facilitate the insertion of a needle into a patient and the delivery of medication through the needle, the patch assembly comprising: main body; A needle, which is fixedly attached to the body; A needle protector, said needle protector being movably attached to at least a portion of the body and configured to be surrounded by at least a portion of the body; and A needle guard biasing member, wherein the needle guard biasing member is positioned within and surrounded by the body. The application of force to the upper body is configured to initiate movement of the needle relative to the lower body assembly and the needle guard.

[0074] 2B. The patch assembly according to embodiment 1B, wherein the body is configured to contact the patient at or near a desired needle insertion site on the patient, the body comprising a lower body and an upper body, the upper body being movably attached to the lower body along an axis.

[0075] 3B. The patch assembly according to embodiment 2B, wherein the needle is fixedly attached to a portion of the upper body, and the needle is configured to be fluidly connected to a cartridge containing a drug.

[0076] 4B. The patch assembly according to any one of embodiments 1B to 3B, wherein the needle is fixedly attached to a portion of the upper body, and the needle is configured to be fluidly connected to a cartridge containing a drug.

[0077] 5B. The patch assembly according to any one of embodiments 1B to 4B, wherein the needle guard biasing member is positioned within and surrounded by the lower body, the upper body and the needle guard, and the needle guard biasing member extends along the axis.

[0078] 6B. The patch assembly according to any one of embodiments 1B to 5B, wherein applying the force to the upper body is configured to initiate movement of the needle relative to the lower body assembly and the needle protector.

[0079] 1C. A patch assembly including a carriage fixedly attached to a needle, the carriage being rotated by pressing a button, which in turn causes the needle to translate toward the patient and enter the patient's body.

[0080] 1D. A patch assembly comprising a body, a needle fixedly attached to the body, and a needle protector rotatably housed within the body, wherein when the patch assembly is placed on a patient's skin, pressing the body causes the needle protector to rotate and translate relative to the body, thereby allowing the needle to translate toward and into the patient's body.

[0081] Although the technology disclosed in this invention has been described in detail with reference to specific examples, it will be apparent to those skilled in the art that various changes and modifications can be made without departing from its spirit and scope. Therefore, it should be understood that the technology of this disclosure is not limited to the specific embodiments disclosed, but is intended to cover modifications within the spirit and scope of the technology of this disclosure.

Claims

1. A patch assembly configured to facilitate the insertion of a needle into a patient and the delivery of medication through the needle, the patch assembly comprising: The body is configured to contact the patient at or near the desired needle insertion site; A button, which is movably attached to the body along a first axis, is biased to a non-engaged position; A carriage, the carriage being positioned within the body and configured to rotate relative to the body; A needle, which is fixed to the lower surface of the carriage and extends below the lower surface of the carriage, is configured to be fluidly connected to a cartridge containing a drug. A needle protector, which is movably attached to the body and configured to surround the needle; and A needle guard biasing member is positioned within the main body and the needle guard, the needle guard biasing member extending along a second axis perpendicular to the first axis. Applying force to the button is configured to move at least a portion of the needle beyond the body and begin inserting the needle into the patient.

2. The patch assembly of claim 1, wherein the body comprises an upper body and a lower body, and each of the plurality of spaced-apart channels in the lower body is configured to receive one of a plurality of spaced-apart tabs extending outwardly from the needle protector.

3. The patch assembly according to any of the preceding claims, wherein the needle protector includes a plurality of clips, each of the plurality of clips being flexible relative to the remainder of the needle protector, each of the plurality of clips being configured to flex at least slightly inward when the needle protector is inserted into the lower body, and each of the plurality of clips being configured to flex at least slightly outward once the needle protector is inserted into the lower body to retain the needle protector within the lower body.

4. The patch assembly according to any of the preceding claims, wherein the patch assembly further comprises: A button biasing member is positioned between the button and a portion of the body, the button biasing member biasing the button to the non-engaged position.

5. The patch assembly according to any of the preceding claims, wherein the carriage includes at least two spaced tabs extending outwardly therefrom.

6. The patch assembly according to any of the preceding claims, the patch assembly further comprising a cap attached to the upper body, the cap and the upper body defining an upper body recess, the upper body recess being configured to receive at least a portion of a flexible conduit configured to fluidly connect the needle to the cartridge containing the drug.

7. The patch assembly according to any of the preceding claims, wherein the needle protector is movably attached to the body along the second axis.

8. The patch assembly according to any one of claims 1 to 5, wherein the patch assembly further comprises: A cartridge adapter configured to be removably attached to an injection aid that contains the cartridge containing the drug; and A flexible conduit extending from the cartridge adapter through the firing bias member and into the carriage, the flexible conduit being configured to fluidly connect the needle to the cartridge.

9. The patch assembly of claim 8, wherein the injection aid is configured to removably receive a cartridge containing a drug therein.

10. The patch assembly of claim 8, wherein the injection aid includes a pre-filled drug container integrally formed therein.

11. The patch assembly of claim 8, wherein the firing bias member extends along the second axis.

12. The patch assembly of claim 11, wherein the needle guard bias member is larger than the firing bias member.

13. The patch assembly according to any of the preceding claims, wherein the button comprises two spaced-apart arms extending from a base, each arm comprising a button clip surrounded by a groove formed in the arm.

14. The patch assembly of claim 13, wherein the end of one of the two spaced-apart arms of the button opposite the base includes an actuator configured to engage in a slot formed in the body and configured to engage one of the tabs of the carriage.

15. The patch assembly according to any of the preceding claims, wherein the needle protector is pivotable relative to the body.

16. A patch assembly, the patch assembly comprising: A body configured to contact the patient at or near a desired needle insertion site, the body comprising a lower body and a cartridge movably attached to the lower body along an axis; A needle fixedly attached to a portion of the cartridge, the needle being configured to be fluidly connected to the cartridge containing the drug; A needle protector, which is movably attached to the lower body and configured to be surrounded by the lower body; and A needle guard biasing member is positioned within and surrounded by the lower body, the cartridge, and the needle guard, and extends along the axis.

17. The patch assembly of claim 16, wherein applying force to the cartridge is configured to initiate movement of the needle relative to the lower body assembly and the needle protector.

18. The patch assembly of claim 17, wherein the cartridge includes a body cap and a body upper portion, at least a portion of the body cap extending into an internal cavity defined by the body upper portion.

19. The patch assembly of claim 17 or 18, wherein the lower body includes a lower body portion and a body interior, at least a portion of the body interior extending into an internal cavity defined by the lower body portion.

20. The patch assembly of claim 19, wherein the upper body portion includes a plurality of spaced-apart clips extending therefrom, and the lower body portion includes a plurality of spaced-apart pawls, each pawl being configured to receive at least a portion therein of one of the plurality of spaced-apart clips.

21. The patch assembly according to any one of claims 17 to 20, wherein the needle protector is configured to rotate relative to the lower body and move relative to the lower body along the axis.

22. The patch assembly according to any one of claims 17 to 21, wherein the needle protector includes a plurality of spaced tabs, and the body interior includes a plurality of spaced flanges therein, each of the plurality of spaced flanges being configured to receive one of the plurality of spaced tabs thereon.

23. The patch assembly according to any one of claims 17 to 22, wherein the patch assembly further comprises: A cartridge adapter configured to be removably attached to an injection aid that contains the cartridge containing the drug; and A flexible conduit extending from the cartridge adapter into the cartridge, the flexible conduit being configured to fluidly connect the needle to the cartridge.

24. The patch assembly of claim 16, further comprising: A button, movably attached to the body, is biased to a non-engaged position. Applying force to the button is configured to move at least a portion of the needle beyond the body and begin inserting the needle into the patient.

25. The patch assembly of claim 24, further comprising: A button biasing member is positioned between the button and a portion of the body, the button biasing member biasing the button to the non-engaged position.

26. The patch assembly according to claim 24 or 25, further comprising: A cartridge adapter configured to be removably attached to an injection aid that contains the cartridge containing the drug; and A flexible conduit extending from the cartridge adapter through the firing bias member and into the carriage, the flexible conduit being configured to fluidly connect the needle to the cartridge.

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