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

Abstract

A patch assembly configured to facilitate needle insertion into a patient and delivery of medicament through the needle can include a body to contact a patient and a button movably attached to the body along a first axis. A carriage can be positioned within the body and configured to be rotated with respect to the body, and a needle can be fixed to and extend below a lower surface of the carriage. 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 a force to the button can be configured to move at least a portion of the needle beyond the body and initiate insertion of the needle into the patient.

Description

PATCH ASSEMBLY CONFIGURED TO FACILITATE NEEDLE INSERTION INTO A PATIENT AND DELIVERY OF MEDICAMENT THROUGH THE NEEDLE, AND METHOD OF MAKING AND USING SAMEFIELD

[0001] The presently disclosed technology relates generally to medicament delivery and / or needle insertion. More particularly, in one embodiment, the presently disclosed technology relates to a patch assembly configured to facilitate needle insertion into a patient and / or delivery of medicament through the needle.BACKGROUND

[0002] Parenteral pharmaceutical therapies employing needle or cannula into a patient through their skin may be delivered by several means to accommodate a range of dose volumes. Delivery method and dose volume depend on several factors, such as the target location, the volume and concentration of pharmaceutical product required.

[0003] The volume of fluid influences the method of delivery and time to deliver. At the lower end of the volume range, small doses of 5 mL and under may typically be delivered by injection over a period up to 60 seconds. At the upper end of the volume range, infusion therapies may deliver doses in excess of 30 mL over a period of hours. For some pharmaceutical therapies larger than 5 mL but lower than typically suited to infusion, the dose may be administered by manual injection using a larger volume container, for example a 20 mL container over a period up to 5 minutes, or even more.

[0004] The above-described injections can be delivered in any of a variety of ways, such as using a hypodermic or subcutaneous needle, or in an intramuscular injection.Alternatively, the above-described injections can be delivered subcutaneously using a subcutaneous cannula and infusion line connected to the container. Large volumes of medicament must be delivered at a controlled rate over a moderate period. Current best practice requires a health care provider to deliver these using a manual process, applying a steady pressure to slowly deliver the dose over a period of minutes, e.g., 3-5 minutes or ever longer.

[0005] Manual administrations of the above-described type can create several problems. For example, manual injections require manual dexterity and control to maintain a constant controlled rate of injection. Manual injections also require that the health care provider pay close attention and can be time-consuming, which can reduce the efficiency of the health careprovider and the clinic in which they work. The sustained pressure and manual manipulation can also cause discomfort to the health care provider, such as hand cramps.

[0006] Certain conventional delivery systems are bulky, and include or require a relatively large area that contacts or attaches to the patient’ s skin through adhesive. The adhesive contact can be problematic for patients with severe skin conditions. Sometimes patients mistakenly correlate the overall size of these conventional systems to the amount of pain the system will inflict.SUMMARY

[0007] There is a need for a delivery system that is compact and ergonomic, yet able to deliver viscous fluids or medicaments to a patient over a set time period and / or at a constant flowrate. Such a system would minimize or eliminate adhesive skin contact for patients with severe skin conditions, and / or reduce or eliminate a perception of some patients that correlate size of the delivery system to the amount of pain the system will inflict. There is also a need for a device that would be automated or more automated to replace the current manual process, and deliver a robust and reliable alternative.

[0008] The above and other needs are addressed by the presently disclosed technology.

[0009] In one aspect, the presently disclosed technology is directed to a patch assembly configured to facilitate needle insertion into a patient and / or delivery of medicament through the needle. The patch assembly can include a body configured to contact a patient at or near a desired needle insertion site on the patient, and a button movably attached to the body along a first axis. The button can be biased to a non-engaged position. The patch assembly can include a carriage positioned within the body and configured to be rotated with respect to the body, and a needle fixed to and extending below a lower surface of the carriage. The needle can be configured to fluidly connect to a cartridge containing medicament. A needle guard can be movably attached to the body and can be configured to surround the needle. A needle guard biasing member can be positioned within the body and the needle guard. The needle guard biasing member can extend along a second axis, which extends perpendicularly to the first axis. Application of a force to the button can be configured to move at least a portion of the needle beyond the body and initiate insertion of the needle into the patient.

[0010] In another aspect, the presently disclosed technology is directed to a patch assembly configured to facilitate needle insertion into a patient and / or delivery of medicament through the needle. The patch assembly can include a body configured to contact a patient at or near a desired needle insertion site on the patient. The body can include a lower body and a cartridge. The cartridge can be being movably attached to thelower body along an axis. A needle can be fixedly attached to a portion of the cartridge and can be configured to fluidly connect to a cartridge containing medicament. A needle guard can be movably attached to and configured to be surrounded by the lower body. A needle guard biasing member can be positioned within and surrounded by the lower body, the cartridge, and the needle guard. The needle guard biasing member can extend along the axis. Application of a force to the cartridge can be configured to initiate movement of the needle with respect to the lower body assembly and the needle guard.

[0011] In yet another aspect, the presently disclosed technology is directed to a patch assembly that can include a body configured to contact a patient at or near a desired needle insertion site on the patient. The body can include a lower body and a cartridge. The cartridge can be being movably attached to the lower body along an axis. A needle can be fixedly attached to a portion of the cartridge and can be configured to fluidly connect to a cartridge containing medicament. A needle guard can be movably attached to and configured to be surrounded by the lower body. A needle guard biasing member can be positioned within and surrounded by the lower body, the cartridge, and the needle guard. The needle guard biasing member can extend along the axis.BRIEF DESCRIPTION OF THE DRAWINGS

[0012] The following detailed description of the presently disclosed technology, will be better understood when read in conjunction with the appended drawings, wherein like numerals designate like elements throughout. For the purpose of illustrating the presently disclosed technology, there are shown in the drawings various illustrative embodiments. It should be understood, however, that the presently disclosed technology is not limited to the precise arrangements and instrumentalities shown. In the drawings:

[0013] Fig. 1 is a perspective view of a cartridge adapter according to an optional aspect of the presently disclosed technology;

[0014] Fig. 2 is a perspective view of a flexible tubing attached at one end to the cartridge adapter shown in Fig. 1 and at an opposing end to a portion of a patch assembly according to one optional aspect of the presently disclosed technology;

[0015] Fig. 3 is a partially exploded perspective view of the patch assembly partially shown in Fig. 2, wherein the assembly is shown before injection;

[0016] Fig. 4 is a further partially exploded perspective view of the patch assembly shown in Fig. 3;

[0017] Fig. 5 is another partially exploded perspective view of portions of the patch assembly shown in Fig. 3 ;

[0018] Fig. 6 is a cross-sectional perspective view of the patch assembly shown in Fig. 3, taken along line A-A of Fig. 3, wherein a push button is shown in a first or biased position;

[0019] Fig. 7 is a perspective view of certain portions of the patch assembly shown in Fig. 3, wherein the push button is shown in a second or engaged position;

[0020] Fig. 8 is a cross-sectional elevation view of portions of the patch assembly shown in Fig. 3, taken along line A-A of Fig. 3, wherein a needle extends from a bottom of the patch assembly and a needle guard is positioned within the patch assembly;

[0021] Fig. 9 is another cross-sectional elevation view of portions of the patch assembly shown in Fig. 3, taken along line A-A of Fig. 3, wherein the needle guard surrounds the needle and extends outside of the patch assembly;

[0022] Fig. 10 is a partially exploded perspective view of a patch assembly according to an optional aspect of the presently disclosed technology;

[0023] Fig. 11 is a perspective view of the patch assembly show in Fig. 10, wherein certain components have been omitted for clarity;

[0024] Fig. 12 is a cross-sectional elevation view of the patch assembly shown in Fig. 10, taken along line A-A of Fig. 10;

[0025] Fig. 13 is a top plan view of the patch assembly shown in Fig. 11, taken along line A-A of Fig. 10, wherein a push button is shown in a first or biased position;

[0026] Fig. 14 is a top plan view of the patch assembly shown in Fig. 11, wherein a push button is shown in a second or engaged position;

[0027] Fig. 15 is a bottom perspective view of a version of the patch assembly shown in Fig. 10 during injection;

[0028] Fig. 16 is a bottom perspective view of a version of the patch assembly shown in Fig. 10 after injection;

[0029] Fig. 17 is a partially exploded perspective view of a patch assembly according to an optional aspect of the presently disclosed technology;

[0030] Fig. 18 is a cross-sectional elevation view of the patch assembly shown in Fig. 17, taken along line A-A of Fig. 17, wherein a needle guard is shown in a retracted position; and

[0031] Fig. 19 is a partial cutaway view of certain internal components of the patch assembly shown in Fig. 17.DETAILED DESCRIPTION

[0032] While systems, devices and methods are described herein by way of examples and embodiments, those skilled in the art recognize that the presently disclosed technology is notlimited to the embodiments or drawings described. Rather, the presently disclosed technology covers all modifications, equivalents and alternatives falling within the spirit and scope of the appended claims. Features of any one embodiment disclosed herein can be omitted or incorporated into another embodiment.

[0033] Any headings used herein are for organizational purposes only and are not meant to limit the scope of the description or the claims. As used herein, the word “can” is used in a permissive sense (i.e., meaning having the potential to) rather than the mandatory sense (i.e., meaning must). Unless specifically set forth herein, the terms “a,” “an” and “the” are not limited to one element but instead should be read as meaning “at least one.” The terminology includes the words noted above, derivatives thereof and words of similar import.

[0034] As used herein, “and / or” means that either or both of the items separated by such terminology are involved. For example, the phrase “A and / or B” would mean A alone, B alone, or both A and B.

[0035] As used herein, “generally” means “in a general manner” relevant to the term being modified as would be understood by one of ordinary skill in the art.

[0036] Directional phrases used herein, such as, for example and without limitation, top, bottom, left, right, upper, lower, front, back, proximate, distal, and derivatives thereof, relate to the orientation of the elements shown in the drawings and are not limiting upon the claims unless expressly recited therein.

[0037] Referring now in detail to the various figures, wherein like reference numerals refer to like parts throughout, Figs. 1-9 show a patch assembly, generally designated 101, of an optional aspect of the presently disclosed technology that is configured to facilitate needle 103 insertion into a patient and / or delivery of medicament through the needle 103 in an ergonomic and simple-to-activate manner. As explained in detail below, the patch assembly 101 can facilitate needle 103 insertion in one step once the patch assembly 101 is placed on and / or attached to the patient. The injections can be delivered in any of a variety of ways, such as hypodermic, subcutaneous, or intramuscular.

[0038] The patch assembly 101 can optionally be removably and / or movable attachable to a drive system or actuation assembly 26, which can be included in an injection aid 10 (examples of which are shown schematically in Fig. 1 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) that is separate and distinct from the patch assembly 101. For example, the patch assembly 101 can be placed on and / or attached to the skin of the patent, and the injection aid 10 can be separated or at a remote location from the patient. In such anembodiment, the injection aid 10 and the patch assembly 101 can be fluidly and / or operatively connected by flexible tubing 74 through which medicament can flow.

[0039] The drive system 26 of the injection aid 10 can removably receive a syringe or cartridge 16 having a barrel that includes a medicament chamber 18 therein and aligned with or including a plunger 68. This allows, in one optional embodiment, for a relatively small patch attachment to the patient, while maintaining a powerful drive system to deliver medicaments of relatively high viscosity. Alternatively, the drive system of the injection aid 10 can have an integral container that is prefilled or filled at the time of use.

[0040] As shown in Figs. 1 and 2, the patch assembly 101 and / or a fluid path thereof or attachable thereto can optionally include an adapter 94 configured to be attached to the injection aid 10 and / or a distal or exit end of the cartridge 16. The adapter 94 can be removably or fixedly attached to the injection aid 10. The adapter 94 can also be fixedly attached, such as by bonding, to one end of the flexible tubing 74. The flexible tubing 74 is configured to fluidly connect the needle 103, optionally formed of steel, to the cartridge 16 containing medicament.

[0041] The adapter 94 can optionally be in the form of or include a bow 95 that ensures that there is always at least a short straight section of tubing 74 for interaction with at least a portion of the injection aid 10. The bow 95 replaces the Luer attachment or fitting of a prior art adapter. One or more clips or arms 97 on a proximal end of the adapter 94 can flex to receive a portion of the cartridge 16 therein to fluidly connect the cartridge 16 to the tubing 74. Optionally, the arms 97 can be configured to removably receive a 13 mm vial or cartridge. A spike 93, which can be surrounded by and / or spaced inwardly from the arms 97, can be configured to pierce a septum of the cartridge 16.

[0042] Referring to Figs. 3, 4, and 6, the patch assembly 101 can include a body 111. A bottom or distal surface of the body 111 is configured to directly contact the patient’s skin P at or near a desired needle insertion site on the patient. The bottom or distal surface of the body 111 can optionally include a fastener, such as adhesive, to temporarily attach or adhere to the skin of the patient. Optionally, the body 111 can include an upper body I l la and a lower body 111b, which can clip or snap-fit together.

[0043] As shown in Figs. 5-9, the lower body 111b can include at least one or two spaced-apart and vertically extending channels 113 therein and / or on an interior surface thereof. Optionally, the channels 113 are diametrically opposed in the lower body 111b. A ledge 113a can extend within the lower body 111b adjacent each channel 113. Each ledge 113b can extend perpendicularly to the respective channel 113. Optionally, each ledge 113acan be a cut-out or level depression formed at, in, or near an upper rim of the lower body 111b.

[0044] The lower body 111b can also include at least one or three or more evenly spacedapart and vertically extending slots 113b therein. The slots 113b can extend parallel to the channels 113, and perpendicular to a flat bottom surface of the lower body 11 lb. The lower body 111b can also include at least one or three or more evenly spaced-apart holes 113c extending through a sidewall thereof. Each of the holes 113c can be spaced-apart from or above the bottom surface of the lower body 11 lb. Optionally, each of the channels 113, the slots 113b, and the holes 113c can be radially offset from one another.

[0045] In one optional embodiment, as shown in Figs. 3, 4, 6, 8, and 9, a cover 121 can be removably or fixedly attached to the upper body Il la. The cover 121 and the upper body I lla can define an upper body recess 123 therebetween. The upper body recess 123 can be configured to receive at least a portion of the flexible tubing 74 therein. Optionally, as shown in Fig. 3, the upper body recess 123 can be sized, shaped, and or configured to receive an excess amount or loop of the flexible tubing 74. This excess amount or loop can be used to account for and / or permit movement of portions of the patch assembly 101 with respect to the body 111. For simplicity, the loop has been omitted from Figs. 8 and 9.

[0046] The patch assembly 101 of the present embodiment can optionally be button activated. However, other forms of actuation, such as direct user engagement of another component of the patch assembly 101, are possible. More particularly, referring to the optional embodiment shown in Figs. 3-9, the patch assembly 101 can include a button 131 movably attached to the body 111 and / or the lower body 111b along a first axis A (see Fig. 4). The first axis A optionally extends parallel to the flat bottom surface of the lower body 111b, and parallel to the patient’s skin P. In addition, the first axis A optionally extends perpendicularly to the channels 113 of the lower body 111b.

[0047] The button 131 can be movable between a first or non-engaged position (see, e.g., Figs. 3 and 6) and a second or engaged position (see, e.g., Figs. 7-9). In the first or nonengaged position, at least a portion of the button 131 can extend radially outwardly beyond the body 111. In the second or engaged position, the entirety of the button 131 can be positioned inside an outer periphery of the body 111.

[0048] As shown in Figs. 4, 5, and 7, the button 131 can optionally include at least one or two spaced-apart arms 133 extending from a base 134. The arms 133 can be spaced-apart in a direction perpendicular to the first axis A. A first arm 133a of the two spaced-apart arms 133 can be at least slightly longer than a second arm 133b of the two spaced-apart arms 133.A distal end of the first arm 133a can be in the form of a pusher or blunt surface that is configured to fit within a slot or groove 115 (see Figs. 5 and 7) formed in the body 111 and / or the lower body 111b.

[0049] Optionally, a button biasing member 135, which can be in the form of a coil spring, can be positioned between the base 134 of the button 131 and a portion of the body 111. The button biasing member 135 can be positioned between the first and second arms 133a, 133b, and can extend along the first axis A. The button biasing member 135 can be configured to bias the button 131 to the non-engaged position. A spring force of the button biasing member 135 can be relatively easily overcome by a user or healthcare professional pressing on the button 131 with his / her finger or thumb.

[0050] Referring to Figs. 2, 4, and 6-9, in one optional embodiment, the patch assembly 101 can include a carriage 141 positioned within the body 111. The carriage 141, which can be generally cylindrical in form, can be configured to be rotatable and translatable with respect to the body 111 along a second axis B (see Fig. 5). The second axis B can be perpendicular to the first axis A. An end of the flexible tubing 74 opposite the adapter 94 can be fixedly attached, such as through bonding, to the carriage 141 along the second axis B. Thus, the carriage 141 and be movable with respect to the body 111 and fixedly attached to an end of the flexible tubing 74.

[0051] As shown in Figs. 2, 6, 8, and 9, the needle 103 can be fixed to the carriage 141 and can extend outwardly therefrom along the second axis B. Optionally, the needle 103 extends perpendicularly to a planar bottom surface of the carriage 141. When the carriage 141 is placed within the body 111, at least a portion of the needle 103 extends below a lower or bottom surface of the carriage 141, and at least a portion of the needle 103 is surrounded by the carriage 141. As explained in detail below, rotation of the carriage 141 allows the needle 103 to be inserted into the patient.

[0052] A firing biasing member 145, such as a coil spring, can surround at least a portion of the flexible tubing 74 within the body 111 at or near the carriage 141. The firing biasing member 145 can extend along the second axis B and be positioned within the body 111. In one optional embodiment, one end of the firing biasing member 145 is attached to or contacts the carriage 141, and an opposing end of the firing biasing member 145 can contact an interior surface of the upper body I l la.

[0053] The carriage 141 can include at least one or two spaced-apart tabs 143 extending outwardly from a generally arcuate sidewall thereof. Optionally, the tabs 143 can be diametrically opposed, and located at or near a top surface of the carriage 141. Each tab 143can be configured to be engaged by the pusher of the first arm 133a of the button 131 through the slot 115, which can cause the carriage 141 to rotate within the body 111. Prior to engagement of the button 131, each tab 143 can also rest on and / or engage the ledge 113a of the lower body 111b. Each tab 143 can be sized, shaped, and / or configured such that following engagement of the button 131, each tab 143 fits within and / or moves within (e.g., be confined by) one of the channels 113 of the lower body 111b.

[0054] In one optional embodiment, as shown in Figs. 4-9, the patch assembly 101 can include a needle guard 151 movably attached to the body 111 and / or the lower body 11 lb. More particularly, the needle guard 151 can optionally be movable along the second axis B (see Fig. 5). The needle guard 151 is configured to automatically surround the needle 103, such as following delivery of the medicament into the patient, to protect the patient and others from the needle 103.

[0055] The needle guard 151 can include at least one or a plurality of spaced-apart tabs 153 (see Fig. 5). Three spaced-apart tabs 153 are shown in the figures, but more or fewer tabs 153 are possible. Each of the tabs 153 can extend outwardly from an exterior surface of a sidewall of the needle guard 151. Optionally, each tab 153 is fixed with respect to the sidewall of the needle guard 151 and integrally formed therewith.

[0056] Fig. 5 also shows at least one or a plurality of spaced-apart retention clips 157, which are optionally included with or are formed in a sidewall of the needle guard 151. Each clip 157 can be radially spaced-apart from each tab 153. In contrast to the tabs 153, each of the plurality of clips 157 is flexible with respect to a remainder of the needle guard 151.Each of the clips 157 includes a portion that is biased to extend radially outwardly beyond a sidewall of the needle guard 157 in an initial position, and each clip 157 is configured to flex at least slightly inwardly as the needle guard 151 is inserted into the lower body 11 lb. Each of the clips 157 can be configured to flex at least slightly outwardly once the needle guard 151 is inserted into the lower body 111b to retain the needle guard 151 within the lower body 111b.

[0057] To assemble the patch assembly 101, the needle guard 151 can be inserted into a bottom of the lower body 111b along the second axis B. As the needle guard 151 is inserted into the lower body 111b from below and moved into the interior of the lower body 111b, each of the tabs 153 can be received by one of a plurality of spaced-apart slots 113b of the lower body 11 lb. Optionally, once the tabs 153 are located at or in the respective slot 113b, the needle guard 151 cannot be easily removed from the lower body 11 lb. In addition, the clips 157 can be flexed inwardly (e.g., perpendicularly to the second axis B) simultaneously(e.g., with an assembly tool or other fixture) as the needle guard 151 is pushed axially along the second axis B until each clip 157 reaches and extends partially into one of the openings 113c. This combination of steps sets the needle guard 151 at a retracted position (e.g., see Figs. 6 and 8).

[0058] As shown in Figs. 4, 6, 8, and 9, the patch assembly 101 can include a needle guard biasing member 161, optionally in the form of a coil spring, positioned within the body 111, the upper body I l la, the lower body 111b, and / or the needle guard 151. The needle guard biasing member 161 can extend along the second axis B. Optionally, the needle guard biasing member 161 is larger, wider, and / or creates a stronger spring force than the firing biasing member 145, and the two biasing members 161, 145 are separated by the carriage 141 within the body 111, as shown in Figs. 8 and 9.

[0059] In operation, application of force to the button 131 (e.g., in a directly parallel to the patient’s skin P) moves at least a portion of the needle 103 beyond the body 111 and initiates insertion of the needle 103 into the patient. More particularly, triggering of the needle 103 and / or the carriage 141 is achieved by rotary means about the second axis B. In the prior art, triggering is often achieved through deflection of clips. However, a disadvantage of deflecting clips is that generally they are under load during storage, so they are more prone to creep and accidental release.

[0060] In the initial state or non-triggered state, as shown in Fig. 6, the carriage 141 is under compressive spring force provided by the firing biasing member 145. At this point, the carriage 141 is restricted from moving or rotating by the tabs 143 that rest on the ledges 113a (e.g., see Fig. 7) of the lower body 11 lb. The carriage 141 is biased to rotate counterclockwise or away from the channels 113. The needle guard 151 is also under compressive spring force by the larger diameter needle guard biasing member 161. In this state, the clips 157 (see, e.g., Fig. 5) retain the needle guard 151 in position. Thus, the force to overcome the clips 157 is greater than the initial spring force of the needle guard biasing member 161.

[0061] As shown in Figs. 7 and 8, pushing the button 131 inwardly and / or along the first axis A applies a small rotation (e.g., 10-20 degrees) to the carriage 141 with respect to the body 111 by means of the pusher of the first arm 133a of the button 131. This has the effect of sliding or rotating each tab 141 clockwise from the ledge 133a toward and into one of the channels 113 cut-out in the lower body 111b.

[0062] As a compressive spring force is applied to the carriage 141 by the firing biasing member 145, the carriage 141 is forced downwardly along the second axis B to an end stop,which sets the needle 103 depth. The carriage 141 also compresses the needle guard biasing member 161 (e.g., compare Figs. 6 and 8), such that the compressive force being applied to the needle guard 151 by the needle guard biasing member 161 is now increased to a point where the spring force is greater than the force created by the clips 157 against the lower body 111b and / or within the openings 113c. However, at this stage, the needle guard 151 does not and cannot deploy or extend outwardly beyond the lower body 111b, since the needle guard 151 is held against the patient’s skin P.

[0063] When the patch assembly 101 is removed or separated from the injection site, the force exerted by the needle guard biasing member 161 overcomes the force of the clips 157 against the lower body 111b and / or within the openings 113c, and the needle guard 151 is forced by the needle guard biasing member 161 to move to its fully extended state (see Fig. 9), which is beyond the lower body 11 lb. In this state, the clips 157 have moved to underneath a locking ledge in an interior of the lower body 111b, which prevents the needle guard 151 from being pushed back into the lower body 111b.

[0064] Optionally, the fluid path can include or consist of the adapter 94, the flexible tubing 74, the firing biasing member 145, the carriage 141, and the needle 103. The fluid path can be a self-contained subassembly of the patch assembly 101. In such an optional embodiment, the fluid path can be installed into the remaining components of the patch assembly 101.

[0065] The patch assembly 101 can optionally have an adhesive area of 1,835 mm2, and a weight of 13.3 grams. In another optional embodiment, the adhesive area can be between 1,500-2,500 mm2, and the weight can be between 12-14 grams.

[0066] Figs. 10-16 show another optional aspect of the presently disclosed technology. The patch assembly 201 shown in Figs. 10-16 has numerous components that are similar or identical to the patch assembly 101 shown in Figs. 1-9 and discussed above. As such, similar or identical structure as between the patch assembly 101 of Figs. 1-9 and the patch assembly 201 of Figs. 10-16 may be distinguished in Figs. 10-16 by a reference number one hundred (100) greater than in Figs. 1-9. Description of certain similarities between the components of Figs. 1-9 and the components of Figs. 10-16 may be omitted herein for convenience and brevity only.

[0067] Similar to the above-described design, the patch assembly 201 can be button activated. However, a distinguishing feature of the patch assembly 201 shown in Figs. 10-16 is that each arm of the button 231 can include a button clip 237a (only one visible in Fig. 11) surrounded by a groove 237b formed in the respective arm 233a, 233b. Each button clip237a can be flexible and / or resilient. For example, at least a portion of each button clip 237a can be configured to engage an opening or groove 237b, which can optionally include an angled or ramp portion, on an interior surface of the lower body 211b, when the button 231 is properly attached to the lower body 211b with the button biasing member 235 therebetween. The interaction between each button clip 237a and corresponding groove 237b of the lower body 211b can provide a light detent when the button 231 is pushed, and / or prevents the button biasing member 235 from forcing the button 231 too far out of the lower body 211b.

[0068] The button biasing member 235 can surround at least a portion of the button 231, such as a projection extending inwardly from the base 234 between the two arms 233a, 233b. The present aspect is also unique because of a visual indicator located on or in the body 211. In particular, the visual indicator can optionally be a window or opening that extends through a portion of the upper body 21 la to visually indicate the lateral position of the button 231. For example, the button 231 can include two or more colors (e.g., yellow and green) or symbols thereon, which can be visible through the window or opening depending upon the lateral position of the button 231 with respect to the body 211. The visual indicator allows a user or healthcare professional to differentiate between a device that is ready to use (e.g., yellow and the button 231 is not depressed), and a device that is in use (e.g., green and the button 231 is depressed). Printed icons could be used instead of or in addition to the varying colors.

[0069] To assemble the patch assembly 201, before or after the button biasing member 235 and the button 231 are properly attached to the lower body 211b, the carriage 241 and / or at least a portion of the fluid path can be placed into the needle guard 251 and the lower body 211b. The carriage 241 can be oriented so that each tab 243 rests on an interior ledges 213a of the lower body 211b, which is adjacent to one of the channels 213. A portion of the flexible tubing 74 can be fed through a slot in the upper body 211a and the firing biasing member 245 can be positioned along the second axis B beneath the upper body 211a and above the carriage 241. The upper body 21 la can be pressed toward and engage the lower body 211b to enclose the components therein. The flexible tubing 74 can extend out of the body 211 through an exit hole formed between the upper and lower bodies 21 la, 21 lb. The cover 221 can then be pressed toward and engage the upper body 211a, while ensuring that a loop or excess amount of the flexible tubing 74 is positioned within the upper body recess 223 (see Fig. 12).

[0070] As shown in Figs. 15 and 16, another distinguishing feature of the patch assembly 201 shown in Figs. 10-16 is that the needle guard 251 can optionally be pivotable withrespect to the body 211. The needle guard 251 can be pivotable between a first or recessed position (see Fig. 15) and a second or exposed position (see, e.g., Fig. 16). In the first or recessed position, a flat or planar bottom of the needle guard 251 can be co-planar with a flat or planar bottom of the lower body 211b, and at least a portion of the needle 203 can extend outwardly beyond the bottom of the needle guard 251. In the second or exposed position, the flat or planar bottom can extend at any of a variety of angles with respect to the flat or planar bottom of the lower body 211b.

[0071] A pivot point 250a, which can be or include as stainless steel dowel pin optionally having a diameter of 0.2 mm, on one side of the needle guard 251 can be used as the location about which the needle guard 251 rotates. One or a pair of clips extending form a body of the needle guard 251 can snap-fit or otherwise engage with a portion of the lower body 211b.

[0072] Optionally, a bottom surface of the needle guard 251 can include an adhesive patch. When the needle 203 insertion is complete, and the patch assembly 201 is removed from the injection site, the needle guard 251 can pivot outwardly away from the lower body 21 lb. The needle guard 251 can include at least one locking guard 251b (see Fig. 16), opposite the pivot point 251a to prevent pivoting of the needle guard 251 before the button 231 is depressed. One advantage of this pivoting design is that the needle guard 251 is unsprung (i.e., the needle guard biasing member 261 can be omitted), and hence does not apply any force to the injection site during infusion.

[0073] The patch assembly 201 can optionally have an adhesive area of 3,565 mm2, and a weight of 23.7 grams. In another optional embodiment, the adhesive area can be between 2,000-4,000 mm2, and the weight can be between 22-25 grams.

[0074] Figs. 17-19 show another optional aspect of the patch assembly 301 of the presently disclosed technology. The patch assembly 301 shown in Figs. 17 and 18 has numerous components that are similar or identical to the patch assembly 101 shown in Figs. 1-9 and discussed above. As such, similar or identical structure as between the patch assembly 101 of Figs. 1-9 and the patch assembly 201 of Figs. 10-16 may be distinguished in Figs. 10-16 by a reference number one hundred (200) greater than in Figs. 1-9. Description of certain similarities between the patch assembly 101 of Figs. 1-9 and the patch assembly 202 of Figs. 17 and 18 may be omitted herein for convenience and brevity only.

[0075] As shown in Figs. 17 and 18, the upper body 311a can include a body cap 314a and a body upper 314b. The upper body 31 la can also be referred to herein as a “carriage”. At least a portion of the body cap 314a can extend into an interior cavity defined by the body upper 314b and include a helical ramp 314c thereon (see Fig. 19). The body cap 314a can beattached to the body upper 314b in any of a variety of ways, such as one or more mechanical fasteners, snap-fits, bonded with adhesive, ultrasonic weld, etc. The lower body 311b can include a body lower 317a and a body inner 317b. At least a portion of the body inner 317b extends into an interior cavity defined by the body lower 317a. The lower body 311b can be attached to the body lower 317a in any of a variety of ways, such as one or more mechanical fasteners, snap-fits, bonded with adhesive, ultrasonic weld, etc.

[0076] In one optional variation, as shown in Figs. 17 and 18, the body upper 314b of the upper body 311a can include at least one or a plurality of evenly spaced-apart clips or projections 371 extending downwardly therefrom. The body lower 317a of the lower body 311b can include at least one or a plurality of evenly spaced-apart and corresponding detents 381 or openings extending through an upper sidewall of the body lower 317a. Each detent 381 can include an angled or sloped portion, and can be configured to receive at least a portion of one of the plurality of spaced-apart clips 371 therein, which attaches the body upper 314b to the body lower 317a. Of course, with certain modifications known by those skilled in the art, the location of the clips 371 and the detents 381 could be inversed or flipped between the body upper 314b and the body lower 317b.

[0077] The needle guard 351 can include a plurality of spaced-apart and outwardly extending tabs 353. Each of tab 353 can be received and / or supported by one of a plurality of ledges 383 on an interior surface of the body inner 317b. A needle guard biasing member 361 can sit within a center cylinder of the needle guard 351 and can extend along the second axis B. As shown in Fig. 19, an interior surface of the needle guard 351 can also include a helical ramp 314d, which complements the helical ramp 314c of the body cap 314a.

[0078] A distinguishing feature of an optional embodiment of the patch assembly 301 shown in Figs. 17 and 18 is that the upper body 31 la is movably attached to the lower body 311b, such as along the second axis B, during operation. This movement can result in needle insertion into the patient. Thus, the patch assembly 301 is optionally manually activated by directly engaging the upper body 311a toward or against the patient, instead of button activated in a direction parallel to the patient’s skin. The axial vertical movement downward on the upper body 311a directly drives the needle 303 into the injection site, it also imparts a rotation in the needle guard 351, which has the effect of releasing the needle guard 251 from the lower body 311b. However, other forms of activation are possible, such as button activation.

[0079] The fluid path can include or consist of the flexible tubing 74, the body cap 314a, and the needle 303. As shown in Fig. 18, the fluid path can include a fixed or rigid bend,such as an exactly or approximately 90° degree bend, that is integrated into the upper body 311a and / or the body cap 314a. No firing biasing member is used, and no loop of the flexible tubing 74 is needed to accommodate movement of a portion of the flexible tubing 74.

[0080] In operation, application of force on or to the upper body 311a (e.g., downward or toward the patient’s skin) moves at least a portion of the needle 303 beyond the body 311 and initiates insertion of the needle 303 into the patient. In particular, the needle guard 351 is configured to rotate with respect to the lower body 311b. This rotation allows the needle guard 351 to translate or move along the second axis B with respect to the lower body 311b. As a result, manually pushing on the upper body 311a moves the needle 303 into the patient at the injection side. This manually pushing also imparts rotation in the needle guard 351, which has the effect of releasing the needle guard 351 from the body 311.

[0081] Application of a sufficient downward force on the upper body 311a overcomes the force created by retention clips extending outwardly from the needle guard 351. This action releases the needle guard 351 from within the lower body 311b. An inner core of the upper body 311a and / or a portion of the body cap 314a can include the helical ramp 314c, which can interact with the corresponding helical ramp 314d on an interior surface of the needle guard 351. The axial movement of the upper body 311a imparts a rotation in the needle guard 351. This has the effect of sliding tabs of the needle guard 351 from a corresponding ledge of the inner body 317b, and into a corresponding vertical channel in the inner body 317b.

[0082] At the full depth of needle 303 travel, the upper body 311a locks out with the lower body 31 lb by the same or similar means as explained in the prior version, such as retention clips. As a result, the patch assembly 301 cannot be easily reset after use. At the same time, the needle guard biasing member 361 applies a force that would extend the needle guard 351. However, however at this stage, the needle guard 351 does not deploy since it is held against the patient’s skin. When the patch assembly 301 is removed from the injection site; the needle guard 351 is forced by the needle guard biasing member 361 to move to its fully extended state at least partially below or beyond the lower body 311b. The needle guard 351 can be locked out in the same or a similar was as in the previous versions, such as with flexible clips on the needle guard 351 locking underneath a ledge on the lower body 311b, optionally in three distinct places.

[0083] The patch assembly 301 can optionally have an adhesive area of 3,660 mm2, and a weight of 16.1 grams. In another optional embodiment, the adhesive area can be between 2,000-4,000 mm2, and the weight can be between 15-18 grams.

[0084] The following exemplary embodiments further describe optional aspects of the presently disclosed technology and are part of this Detailed Description. These exemplary embodiments are set forth in a format substantially akin to claims (each with numerical designations followed by a capital letter), although they are not technically claims of the present application. The following exemplary embodiments refer to each other in dependent relationships as “embodiments” instead of “claims.”

[0085] 1A. A patch assembly configured to facilitate needle insertion into a patient and delivery of medicament through the needle, the patch assembly comprising: a body; a button movably attached to or positioned in the body; a carriage positioned within the body and configured to be rotated with respect to the body; a needle fixed to the carriage; a needle guard movably attached to the body; and a needle guard biasing member positioned within the body and the needle guard, wherein application of a force to the button is configured to move at least a portion of the needle beyond the body and initiate insertion of the needle into the patient.

[0086] 2 A. The patch assembly of embodiment 1A, wherein the body is configured to contact a patient at or near a desired needle insertion site on the patient.

[0087] 3 A. The patch assembly of embodiment 1A or 2 A, wherein the button is movably with respect to the body along a first axis, the button being biased to a non-engaged position.

[0088] 4A. The patch assembly of any one of embodiment 1A-3A, wherein the needle extends below a lower surface of the carriage, the needle being configured to fluidly connect to a cartridge containing medicament.

[0089] 5A. The patch assembly of any one of embodiment 1A-4A, wherein the needle guard is configured to surround the needle.

[0090] 6A. The patch assembly of any one of embodiment 1A-5A, wherein the needle guard being configured to surround the needle.

[0091] 7A. The patch assembly of any one of embodiment 1A-6A, wherein the needle guard biasing member extends along a second axis, the second axis extending perpendicularly to the first axis.

[0092] IB. A patch assembly configured to facilitate needle insertion into a patient and delivery of medicament through the needle, the patch assembly comprising:a body; a needle fixedly attached to the body; a needle guard movably attached to and configured to be surrounded by at least a portion of the body; and a needle guard biasing member positioned within and surrounded by the body, wherein application of a force to the upper body is configured to initiate movement of the needle with respect to the lower body assembly and the needle guard.

[0093] 2B. The patch assembly according to embodiment IB, wherein the body is configured to contact a patient at or near a desired needle insertion site on the patient, the body including a lower body and an upper body, the upper body being movably attached to the lower body along an axis.

[0094] 3B. The patch assembly according to embodiment 2B, wherein the needle is fixedly attached to a portion of the upper body, the needle being configured to fluidly connect to a cartridge containing medicament.

[0095] 4B. The patch assembly according to any one of embodiment 1B-3B, wherein the needle is fixedly attached to a portion of the upper body, the needle being configured to fluidly connect to a cartridge containing medicament.

[0096] 5B. The patch assembly according to any one of embodiment 1B-4B, wherein the needle guard biasing member is positioned within and surrounded by the lower body, the upper body, and the needle guard, the needle guard biasing member extending along the axis.

[0097] 6B. The patch assembly according to any one of embodiment 1B-5B, wherein application of the force to the upper body is configured to initiate movement of the needle with respect to the lower body assembly and the needle guard.

[0098] 1C. A patch assembly comprising a carriage fixedly attached to a needle is rotated by depressing a button, which in turn causes the needle to translate toward and into a patient.

[0099] ID. A patch assembly comprising a body, a needle fixedly attached to the body, and a needle guard rotatably contained within the body, wherein pressing on the body when the patch assembly is placed on a patient’s skin causes the needle guard to rotate and translate with respect to the body, thereby allowing the needle to translate toward and into the patient.

[0100] While the presently disclosed technology has been described in detail and with reference to specific examples thereof, it will be apparent to one skilled in the art that variouschanges and modifications can be made therein without departing from the spirit and scope thereof. It is understood, therefore, that the presently disclosed technology is not limited to the particular embodiments disclosed, but it is intended to cover modifications within the spirit and scope of the presently disclosed technology.

Claims

CLAIMSWhat is claimed is:

1. A patch assembly configured to facilitate needle insertion into a patient and delivery of medicament through the needle, the patch assembly comprising: a body configured to contact a patient at or near a desired needle insertion site on the patient; a button movably attached to the body along a first axis, the button being biased to a non-engaged position; a carriage positioned within the body and configured to be rotated with respect to the body; a needle fixed to and extending below a lower surface of the carriage, the needle being configured to fluidly connect to a cartridge containing medicament; a needle guard movably attached to the body, the needle guard being configured to surround the needle; and a needle guard biasing member positioned within the body and the needle guard, the needle guard biasing member extending along a second axis, the second axis extending perpendicularly to the first axis, wherein application of a force to the button is configured to move at least a portion of the needle beyond the body and initiate insertion of the needle into the patient.

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

3. The patch assembly of any previous claim, wherein the needle guard includes a plurality of clips, each of the plurality of clips being flexible with respect to a remainder of the needle guard, each of the plurality of clips being configured to flex at least slightly inwardly as the needle guard is inserted into the lower body, each of the plurality of clips being configured to flex at least slightly outwardly once the needle guard is inserted into the lower body to retain the needle guard within the lower body.

4. The patch assembly of any previous claim, further comprising:a button biasing member 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 of any previous claim, wherein the carriage includes at least two spaced-apart tabs extending outwardly therefrom.

6. The patch assembly of any previous claim, further comprising a cover attached to the upper body, the cover and the upper body defining an upper body recess configured to receive at least a portion of a flexible tubing, the flexible tubing being configured to fluidly connect the needle to the cartridge containing medicament.

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

8. The patch assembly of any one of claims 1-5, further comprising: a cartridge adapter configured to removably attach to an injection aid, the injection aid housing the cartridge containing medicament; and a flexible tubing extending from the cartridge adapter, through a firing biasing member, and into the carriage, the flexible tubing being configured to fluidly connect the needle to the cartridge.

9. The patch assembly of claim 8, wherein the injection aid being configured to removably receive a cartridge containing medicament therein.10 The patch assembly of claim 8, wherein the injection aid includes a prefilled medicament container integrally formed therein.

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

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

13. The patch assembly of any preceding claim, wherein the button includes twospaced-apart arms extending from a base, each arm including a button clip surrounded by a groove formed in the arm.

14. The patch assembly of claim 13, wherein an end of one of the two spacedapart arms of the button opposite the base includes a pusher, the pusher being configured to fit within a slot formed in the body and configured to engage one of the tabs of the carriage.

15. The patch assembly of any previous claim, wherein the needle guard is pivotable with respect to the body.

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

17. The patch assembly of claim 16, wherein application of a force to the cartridge is configured to initiate movement of the needle with respect to the lower body assembly and the needle guard.

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

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

20. The patch assembly of claim 19, wherein the body upper includes a plurality of spaced-apart clips extending therefrom, the body lower including a plurality of spacedapart detents, each detent being configured to receive at least a portion of one of the plurality of spaced-apart clips therein21. The patch assembly of any one of claims 17-20, wherein the needle guard is configured to rotate with respect to the lower body and move along the axis with respect to the lower body.

22. The patch assembly of any one of claims 17-21, wherein the needle guard includes a plurality of spaced-apart tabs, the body inner including a plurality of spaced-apart ledges on an interior thereof, each of the plurality of spaced-apart leges being configured to receive one of the plurality of spaced-apart tabs thereon.

23. The patch assembly of any one of claims 17-22, further comprising: a cartridge adapter configured to removably attach to an injection aid, the injection aid housing the cartridge containing medicament; and a flexible tubing extending from the cartridge adapter into cartridge, the flexible tubing 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, the button being biased to a non-engaged position, wherein application of a force to the button is configured to move at least a portion of the needle beyond the body and initiate insertion of the needle into the patient.

25. The patch assembly of claim 24, further comprising: a button biasing member 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 of claim 24 or 25, further comprising: a cartridge adapter configured to removably attach to an injection aid, the injection aid housing the cartridge containing medicament; and a flexible tubing extending from the cartridge adapter, through a firing biasing member, and into the carriage, the flexible tubing being configured to fluidly connect theneedle to the cartridge.

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