A microneedle patch applicator

Abstract

A microneedle patch applicator device (1) comprises a plunger (2) having a distal microneedle patch abutting surface (19) and a receiver (3) for the plunger. The plunger is configured for reciprocal linear movement relative to the receiver between an extended configuration in which the distal microneedle patch abutting surface is spaced from the receiver and a depressed configuration. The receiver comprises a force limiter associated with the plunger configured to prevent movement of the plunger from the extended configuration to the depressed configuration until a pre-determined threshold input force has been applied to the plunger by the user.

Description

[0001] TITLE

[0002] A microneedle patch applicator

[0003] Field of the Invention

[0004] The present invention relates to a microneedle patch applicator.

[0005] Background to the Invention

[0006] Microneedles (MNs) or Microneedle patches are micron-scaled medical devices used to administer vaccines, drugs, and other therapeutic agents. While microneedles were initially explored for transdermal drug delivery applications, their use has been extended for the intraocular, vaginal, transungual, cardiac, vascular, gastrointestinal, and intracochlear delivery of drugs. Microneedles are made from a variety of material ranging from silicon, titanium, stainless steel, and polymers. Some microneedles are made of a drug to be delivered to the body but are shaped into a needle so they will penetrate the skin. The microneedles range in size, shape, and function but are all used as an alternative to other delivery methods like the conventional hypodermic needle or other injection apparatus. Microneedles are usually applied through even single needle or small arrays. The arrays used are a collection of microneedles, ranging from only a few microneedles to several hundred, attached to an applicator, sometimes a patch or other solid stamping device (Figure 1). The arrays are applied to the skin of patients and are given time to allow for the effective administration of drugs. Microneedles are an easier method for physicians as they require less training to apply and because they are not as hazardous as other needles, making the administration of drugs to patients safer and less painful while also avoiding some of the drawbacks of using other forms of drug delivery, such as risk of infection, production of hazardous waste, or cost.

[0007] However, microneedle injection also has some disadvantages, the biggest problem being how to determine whether the microneedle has penetrated into the skin at an appropriate depth of the skin during microneedle injection. Hollow and coated microneedles both possess the risk that the drug will not properly enter the skin and will not be effective. Both of these types of microneedles can leak onto a person's skin as a result of by damage to the microneedle or incorrect application of the microneedle patch by the patients. More importantly, over-penetrating the microneedle into the skin’s nerve layer can lead to pain for the patient and adversely affects the acceptance of use of the technology. There is a limited amount of literature available on the subject of microneedle drug delivery, as current research is still exploring how to make effective needles. Most of the microneedles currently designed are injected by pressing with people’s fingers, which makes it difficult to regulate the maximum injection force, thus easily leading to needle damage and the inability to completely inject the drug into the skin (Figure 2).

[0008] Device for application of microneedle patches are described in US2015 / 258319 and US2016 / 271380. Both devices employ helical springs which function to limit the input force that a user can apply to a microneedle patch. They are crude devices which do not provide any feedback to a user as to when a maximum applied force has been reached, which can lead to patches being applied without the required level of force. In addition, the devices will perform differently when used by a strong person and a weak person.

[0009] It is an object of the invention to overcome at least one of the above-referenced problems.

[0010] Summary of the Invention The Applicant has addressed the problems of the prior art by providing a device, typically a user-operable device, suitable for applying controlled input force to an object, for example applying a microneedle patch to a surface, that incorporates a force limiting device (force limiter) to control the input force applied. Force limiters detect overload in input force and are configured to trip once a threshold input force is reached to uncouple the load applied to the object. When used to apply a microneedle patch, the device allows a sufficient level of force to be applied to ensure that the microneedles pierce the skin correctly and also indicates to the user once this level of force has been achieved to prevent higher force levels being applied which may damage the microneedles and / or cause unacceptable pain. The device is a plunger-type device comprising a plunger and a receiver for the plunger comprising a force limiter that is associated with the plunger and configured to prevent depression of the plunger until a pre-determined threshold input force has been applied to the plunger by a user. Once the pre-determined threshold input force has been applied to the plunger by the user, the force limiter allows depression of the plunger, thus indicating to the user that the threshold input force has been reached. In one aspect, the force limiter comprises a compliant body configured to deform in response to application by the plunger of the threshold input force (e.g. compliant force limiter) allowing the plunger to depress. The compliant body is typically coupled to the receiver and associated with the plunger (e.g. disposed in a path of movement of the plunger) such that it prevents depression of the plunger until the threshold input force is applied to the plunger whereupon a distal tip of the plunger resiliently deforms the compliant body and pushes past it to allow depression of the plunger. Thus, a user can use the device to press a microneedle patch in place and apply an increasing level of force until the plunger depresses, at which point the use will stop applying force as they will know that the correct pressure has been applied to the patch. The device is generally configured such that a proximal end of the plunger is placed into contact with the microneedle patch and the user holds and applies input force to the receiver (as per the embodiments described herein), but it will be appreciated that the device may also be configured for the user to hold and depress the plunger and place an end of the receiver into contact with the microneedle patch. Described herein is a device, in one embodiment a microneedle patch applicator device, (hereafter “device”) comprising a plunger and a receiver for the plunger comprising a force limiter that is associated with the plunger and configured to prevent depression of the plunger until a pre-determined threshold input force has been applied to the plunger.

[0011] In any embodiment, the force limiter comprises a compliant body.

[0012] In any embodiment, the compliant body is coupled to the receiver and disposed in a path of movement of the plunger that prevents depression of the plunger until the threshold input force is applied to the plunger whereupon the plunger, typically a proximal tip of the plunger, resiliently deforms the compliant body and pushes past it to allow depression of the plunger.

[0013] In any embodiment, the receiver comprises a cylindrical housing.

[0014] In any embodiment, the plunger is mounted in the receiver for reciprocal linear movement between an extended position in which a distal end of the plunger is spaced apart from a distal end of the cylinder and a extended position.

[0015] In any embodiment, the compliant body comprises a sheet or disc of compliant material.

[0016] In any embodiment, the compliant body comprises an annular rim section and one or more leaflets extending inwardly from the annular rim section defining an aperture or apertures in the disc.

[0017] In any embodiment, the compliant body comprises three leaflets equally spaced around the annular rim section.

[0018] In any embodiment, each leaflet has a trapezoid shape. In any embodiment, the leaflets define a central aperture.

[0019] In any embodiment, the central aperture is substantially triangular

[0020] In any embodiment, the receiver (cylindrical housing) comprises a distal section and a proximal section, wherein the disc of compliant material is sandwiched between the distal and proximal sections.

[0021] In any embodiment, the plunger comprises a central rod and a guide head mounted to the central rod for movement therewith, wherein the receiver (e.g an inner wall of the receiver) comprises a slot arrangement configured to receive the guide head to guide movement of the plunger along the cylinder.

[0022] In any embodiment, the distal section of the cylinder comprises a distal part with a lumen configured to receive the central rod and a proximal part comprising the slot arrangement.

[0023] In any embodiment, the proximal section of the cylinder comprises the slot arrangement.

[0024] In any embodiment, the guide head comprises guide petals and the slot arrangement comprises a guide slot configured to receive a respective guide petal in a sliding arrangement.

[0025] In any embodiment, the guide petals of the guide head are aligned with the leaflets of the compliant disc.

[0026] In any embodiment, the plunger comprises a proximal rod section disposed proximally of the guide head, in which the proximal rod section has a preprogrammed (such as frustoconical or mushrooms-shaped) tip. In any embodiment, the distal end of the plunger comprises a patch-abutting base plate.

[0027] In any embodiment, the device is configured to have a pre-determined threshold force of about 1 to about 10 N, about 3 to about 7 N, or about 5 to about 6 N.

[0028] Also described is a device, suitable to apply a microneedle patch, comprising a plunger and a receiver for the plunger comprising a force limiter that is associated with the plunger and configured to prevent depression of the plunger until a predetermined threshold input force has been applied to the plunger, wherein the force limiter comprises a compliant body configured to deform in response to application of the pre-determined threshold input force to the compliant body by the plunger, wherein the deformed compliant body does not prevent depression of the plunger.

[0029] Also described is a device comprising a plunger having a distal microneedle patch abutting surface and a receiver for the plunger, wherein the plunger is configured for reciprocal linear movement relative to the receiver from an extended configuration in which the distal microneedle patch abutting surface is spaced from the receiver to a depressed configuration, and wherein the receiver comprises a force limiter associated with the plunger configured to prevent movement of the plunger from the extended configuration to the depressed configuration until a predetermined threshold input force has been applied to the plunger by the user, in which the force limiter is configured to trip once the pre-determined threshold input force is reached to uncouple input force applied by the user from a resultant load applied to the microneedle patch by the distal microneedle patch abutting surface.

[0030] Also described is a method of applying an object such as a microneedle patch to a subject, comprising the steps of: placing the microneedle patch on a target locus of the subject; positioning the microneedle patch applicator device as described herein over (typically orthogonal to) the microneedle patch with a distal end of the plunger abutting the microneedle patch; and while holding the receiver of the microneedle patch applicator, manually urging the receiver towards the patch until the plunger is depressed relative to the receiver indicating that the threshold input force has been applied to the microneedle patch.

[0031] Also described is a method of applying a controlled input force to an object, comprising the steps of: positioning the device as described herein over (typically orthogonal to) the object with a distal end of the plunger abutting a surface of the object; and while holding the receiver of the device, manually urging the receiver towards the object until the plunger is depressed relative to the receiver indicating that the threshold input force has been applied to the object.

[0032] Other aspects and preferred embodiments of the invention are defined and described in the other claims set out below.

[0033] Brief Description of the Figures

[0034] Figure 1A: Polymeric microneedle patch (Dharadhar et al. "Microneedles for transdermal drug delivery: a systematic review". Drug Development and Industrial Pharmacy. 45 (2): 188-201. https: / / doi.Org / 10.1080 / 03639045.2018.1539497.

[0035] Figure 1B: Solid microneedles viewed under microscope (Dharadhar et al.).

[0036] Figure 1C: Comparison of a microneedle patch (200x200x350 pm) with a standard hollow-bore needle and Electron micrograph of the polystyrene microneedle patch (Panda et al. "Non-dermal applications of microneedle drug delivery systems". Drug Delivery and Translational Research. 12 (1): 67-78. htps: / / doi.Org / 10.1007 / S13346-021 -00922-9).

[0037] Figure 2A-C show the states of microneedles under different input forces as observed in experiments conducted by Park et al ("Spray-formed layered polymer microneedles for controlled biphasic drug delivery." Polymers 11.2 (2019): 369.

[0038] Figure 3 is a front elevational view of microneedle patch applicator of the disclosure with the piston extended.

[0039] Figure 4 is a perspective view of the microneedle patch applicator of Figure 3.

[0040] Figure 5A is an exploded view of the microneedle patch applicator of Figure 3.

[0041] Figure 5B is a perspective (partly transparent) view of a distal part of the cylindrical housing.

[0042] Figure 5C is a perspective view of a proximal part of the cylindrical housing.

[0043] Figure 5D is a perspective view of a central rod and guide head of the plunger.

[0044] Figure 5E is a perspective view of a distal base part of the plunger.

[0045] Figure 5F is a perspective view of a proximal rod part of the plunger.

[0046] Figure 5G is a perspective view of a compliant disc.

[0047] Figure 6 is a photograph of the compliant disc, made of PEEK, of Figure 5G in a palm of a hand illustrating the size of the disc.

[0048] Figure 7 is a photograph of a user holding the microneedle patch applicator of Figure 3 illustrating the size of the microneedle patch applicator.

[0049] Figure 8 illustrates the use of the microneedle patch applicator of Figure 3 to correctly apply a microneedle patch to subject, in which: a microneedle patch is correctly positioned on a target area of a subject (A); the microneedle patch applicator of Figure 3 is positioned over the patch with a patch-abutting base plate of the plunger abutting the microneedle patch (B); holding the cylindrical housing of the applicator with the thumb and forefinger, the use applies downward pressure on the applicator, slowly increasing the downward force applied (C), until the force applied by the user causes the compliant disc to deform allowing the plunger to depress (D), at which point the user stops applying downward pressure.

[0050] Figure 9A is side elevational view of the microneedle patch applicator in use with part of the cylindrical housing cut-away showing the proximal rod part of the plunger abutting the petals of the compliant disc. This illustration shows the position of the proximal rod part of the plunger prior to the threshold input force being reached, with the compliant body preventing plunger depression

[0051] Figure 9B is a sectional view taken along the line l-l of Figure 9A.

[0052] Figure 9C is the same view as Figure 9A but after the input threshold pressure has been reached, where the proximal rod part of the plunger has deformed the petals of the compliant disc allowing the plunger to depress.

[0053] Figure 9D is a sectional view taken along the line ll-ll of Figure 9C.

[0054] Detailed Description of the Invention

[0055] All publications, patents, patent applications and other references mentioned herein are hereby incorporated by reference in their entireties for all purposes as if each individual publication, patent or patent application were specifically and individually indicated to be incorporated by reference and the content thereof recited in full.

[0056] Definitions and general preferences Where used herein and unless specifically indicated otherwise, the following terms are intended to have the following meanings in addition to any broader (or narrower) meanings the terms might enjoy in the art:

[0057] Unless otherwise required by context, the use herein of the singular is to be read to include the plural and vice versa. The term "a" or "an" used in relation to an entity is to be read to refer to one or more of that entity. As such, the terms "a" (or "an"), "one or more," and "at least one" are used interchangeably herein.

[0058] As used herein, the term "comprise," or variations thereof such as "comprises" or "comprising," are to be read to indicate the inclusion of any recited integer (e.g. a feature, element, characteristic, property, method / process step or limitation) or group of integers (e.g. features, element, characteristics, properties, method / process steps or limitations) but not the exclusion of any other integer or group of integers. Thus, as used herein the term "comprising" is inclusive or open- ended and does not exclude additional, unrecited integers or method / process steps.

[0059] Exemplification

[0060] The invention will now be described with reference to specific Examples. These are merely exemplary and for illustrative purposes only: they are not intended to be limiting in any way to the scope of the monopoly claimed or to the invention described. These examples constitute the best mode currently contemplated for practicing the invention.

[0061] Referring to the drawings, and initially to Figures 3 to 6, there is illustrated a microneedle patch applicator (hereafter “applicator”) according to the disclosure and indicated generally by the reference numeral 1. The applicator comprises a plunger 2 and a receiver 3 for the plunger comprising a force limiting mechanism associated with the plunger 3 and configured to prevent depression of the plunger until a pre-determined threshold input force has been applied to the plunger by a user (in this case 5-6 N). Referring to Figure 8, the plunger 2 is configured for reciprocal movement in the receiver 3 from an extended position shown in Figure 8B to a depressed position shown in Figure 8C. The applicator is dimensioned to be held between the thumb and forefinger of a user’s hand (as illustrated in Figure 7).

[0062] In more detail, and referring specifically to Figure 5, one embodiment of the applicator 1 is shown in an exploded view to illustrate its component parts. The receiver comprises a cylindrical housing 5 having a distal cylindrical part 6 and a proximal cylindrical part 7 configured to interconnect upon assembly forming the cylindrical housing 5 (Figures 5B and 5C). Referring to Figure 5A and 5G, a force limiting mechanism, in this case a compliant disc 8 having the same diameter as the cylindrical housing 5, is sandwiched between the distal cylindrical part 6 and proximal cylindrical part 7 upon assembly . The compliant disc 8 is formed from PEEK material and comprises an annular rim 10 and three leaflets 11 attached to the rim 10 that extend radially inwardly from the rim 10. The leaflets 11 have a trapezoidal shape and taper inwardly towards the centre of the disc to define a generally triangular aperture 12 in a centre of the disc 8.

[0063] The PEEK material of the compliant disc has the following mechanical properties:

[0064] Tensile strength at yield 95 MPa

[0065] Elongation at break 25%

[0066] Shore D hardness 90

[0067] Flexural strength 170 MPa

[0068] Modulus of elasticity 3000 MPa

[0069] Referring to Figures 5D, E and F, the plunger 2 has a central shaft 14 with a guide head 15 disposed at a proximal end of the shaft 14, distal base part 16 and a proximal part, referred to herein as a contact beam, 17, that in use is associated with the compliant disc 8. The distal base part 16 comprises a cylindrical section 18 configured to receive a distal end of the central shaft 14 and a microneedle-abutting plate 19 disposed at a distal end of the cylindrical section. The guide head 15 comprises three petals 20 that extend radially outwardly from a proximal tip of the central shaft 14 forming a trefoil shape.

[0070] Referring to Figure 5B, the distal cylindrical part 6 has a distal section 23 with an cylindrical lumen 24 and a proximal section 25 with a trefoil-shaped lumen 26 dimensioned to receive the trefoil-foil shaped guide head 15 in a snug but sliding relationship. A base 27 of the trefoil-shaped lumen acts as a stop to limit the retraction of the plunger 2 relative to the receiver 3.

[0071] Referring to Figure 5C, the proximal cylindrical part 7 has a trefoil-shaped lumen 28 dimensioned to align with the trefoil-shaped lumen 26 when the distal cylindrical part 6 and proximal cylindrical part 7 are connected together to form an elongated trefoil shaped lumen that functions to guide the movement of the guide head 15 and plunger 2 along the receiver 3.

[0072] The applicator 1 is assembled by attaching the contact beam 17 to a centre of the guide head 15, and threading the central shaft 14 through the lumen of the distal cylindrical part 6 so that the guide head 15 is received in the (first) trefoil shaped lumen 26 and a distal end of the central shaft 14 projects out of a distal end of the distal cylindrical part 6. The distal base part 16 is then attached to the distal end of the central shaft 14. The compliant disc 8 is then placed on top of the distal cylindrical part 6 and correctly aligned such that the leaflets 11 overlie the first trefoil-shaped lumen 26. The proximal cylindrical part 7 is then placed on top of the compliant disc 8 and correctly aligned such that the leaflets 11 are aligned with the second trefoil-shaped lumen 28, and the distal and proximal cylindrical parts 6, 7 and connected together sandwiching the compliant disc 8. When the plunger is fully extended the distal base part of the plunger is spaced from a distal end of the cylindrical housing 5 (see Figure 9A), the guide head 15 is positioned within the first trefoil-shaped lumen 26 abutting the base 27, and a distal end of the contact beam 17 is disposed just distally of the compliant disc (see Figure 9A). In use, and referring to Figure 8, the applicator is used to apply a microneedle (MN) patch 30 to the skin 31 of a user. The MN patch 30 is usually applied by hand to a target location gently and without any pressure applied (Figure 8A). The applicator 1 is then set with the plunger 2 in a extended configuration, grasped between the thumb 33 and forefinger 34 of the user’s hand 35 and positioned above the patch 30 with the patch abutting plate 19 disposed directly above the patch 30 (Figure 8B). The user then applied downward force to the applicator to press the patchabutting plate 19 into contact with the patch 30 and continues applying increasing downward force to the applicator (Figure 8C) until the plunger depresses as shown in Figure 8D. During this process, the increasing input force applied by the user has forced the contact beam 17 against the leaflets 11 of the compliant disc until a threshold input pressure is reached whereupon the contact beam deforms the leaflets to push proximally through and beyond the compliant disc 8 resulting in the plunger being depressed into the receiver. Once this occurs, the user stops allying force as the correct level of input force has been applied to the MN patch. To re-use the applicator, the user simply retracts the plunger manually to the extended configuration.

[0073] Reference Numerals

[0074] Applicator 1

[0075] Plunger 2

[0076] Receiver 3

[0077] Cylindrical housing 5

[0078] Distal cylindrical part 6

[0079] Proximal cylindrical part 7

[0080] Compliant disc 8

[0081] Annular rim 10

[0082] Leaflets 11

[0083] Triangular aperture 12 Central shaft 14

[0084] Guide head 15

[0085] Distal base part 16

[0086] Proximal rod (Contact beam) 17

[0087] Cylindrical section 18

[0088] Patch-abutting plate 19

[0089] Three petals 20

[0090] Distal section 23

[0091] Cylindrical lumen 24

[0092] Proximal section 25

[0093] (1st) trefoil-shaped lumen 26

[0094] Base 27

[0095] (2nd) trefoil-shaped lumen 28

[0096] Microneedle patch 30

[0097] Skin 31

[0098] Thumb 33

[0099] Forefinger 34

[0100] Hand 35

[0101] Equivalents

[0102] The foregoing description details presently preferred embodiments of the present invention. Numerous modifications and variations in practice thereof are expected to occur to those skilled in the art upon consideration of these descriptions. Those modifications and variations are intended to be encompassed within the claims appended hereto.

Claims

CLAIMS:1 . A microneedle patch applicator device (1 ) comprising a plunger (2) having a distal microneedle patch abutting surface (19) and a receiver (3) for the plunger, wherein the plunger is configured for reciprocal linear movement relative to the receiver between an extended configuration in which the distal microneedle patch abutting surface is spaced from the receiver and a depressed configuration, and wherein the receiver comprises a force limiter comprising a compliant body (8) coupled to the receiver (3) and disposed in a path of movement of the plunger (2) that prevents depression of the plunger until a threshold input force is applied to the plunger by a user whereupon a proximal end of the plunger resiliently deforms the compliant body and pushes past it to allow depression of the plunger.

2. A microneedle patch applicator device (1) according to Claim 1 , in which the receiver (3) is dimensioned to be held between a thumb (33) and one or more fingers (34) of a user’s hand.

3. A microneedle patch applicator device (1) according to any preceding Claim, in which the receiver (3) comprises a cylinder.

4. A microneedle patch applicator device (1) according to any preceding Claim, in which the compliant body (8) comprises a disc of compliant material having an annular rim section (10) and one or more leaflets (11) extending inwardly from the annular rim section defining a central aperture (12).

5. A microneedle patch applicator device (1) according to Claim 4, in which the compliant body (8) comprises three leaflets (11) equally spaced around the annular rim section (10).

6. A microneedle patch applicator device (1) according to Claim 4 or 5, in which each leaflet (11) has a trapezoid shape.

7. A microneedle patch applicator device (1) according to Claim 4, in which the receiver (3) comprises a distal part (6) and a proximal part (7), wherein the disc of compliant material is sandwiched between the distal and proximal parts upon assembly of the receiver.

8. A microneedle patch applicator device (1) according to any preceding Claim, in which the plunger (2) comprises a central shaft (14) and a guide head (15) mounted to the central shaft for movement therewith, wherein the receiver (3) comprises a first guide head shaped lumen (26) configured to receive the guide head in a tight but sliding relationship.

9. A microneedle patch applicator device (1) according to Claim 8, in which the plunger (2) comprises a proximal rod section (contact beam) (17) disposed proximally of the guide head (15).

10. A microneedle patch applicator device (1) according to Claim 7 and 8, in which the distal part (6) of the receiver (3) comprises a distal section (23) with a lumen (24) configured to receive the central shaft (14) and a proximal section (25) comprising the first guide head shaped lumen (26).11 . A microneedle patch applicator device (1 ) according to Claim 7 and 8, in which the proximal part (7) of the receiver (3) comprises a second guide head shaped lumen (28).

12. A microneedle patch applicator device (1 ) according to any of Claims 8 to 11 , in which the guide head (15) is trefoil shaped.

13. A microneedle patch applicator device (1) according to any preceding Claim, for use in applying a microneedle patch to a user with controlled maximum input force.

14. A method of applying a microneedle patch to a subject, comprising the steps of:17 placing the microneedle patch on a target locus of the subject; positioning a microneedle patch applicator device of any of Claims 1 to 13 over the microneedle patch with the microneedle patch abutting surface abutting the microneedle patch; and while holding the receiver of the microneedle patch applicator, manually urging the receiver towards the patch until the plunger is depressed relative to the receiver indicating that the threshold input force has been applied to the microneedle patch.

15. A microneedle patch applicator device comprising a plunger and a receiver for the plunger comprising a force limiter that is associated with the plunger and configured to prevent depression of the plunger until a pre-determined threshold input force has been applied to the plunger, wherein the force limiter comprises a compliant body configured to deform in response to application of the predetermined threshold input force to the compliant body by the plunger, wherein the deformed compliant body does not prevent depression of the plunger.

16. A microneedle patch applicator device comprising a plunger having a distal microneedle patch abutting surface and a receiver for the plunger, wherein the plunger is configured for reciprocal linear movement relative to the receiver between an extended configuration in which the distal microneedle patch abutting surface is spaced from the receiver and a depressed configuration, and wherein the receiver comprises a force limiter associated with the plunger configured to prevent movement of the plunger from the extended configuration to the depressed configuration until a pre-determined threshold input force has been applied to the plunger by the user, in which the receiver (3) is dimensioned to be held between a thumb (33) and one or more fingers (34) of a user’s hand.

16. A microneedle patch applicator device comprising a plunger having a distal microneedle patch abutting surface and a receiver for the plunger, wherein the18 plunger is configured for reciprocal linear movement relative to the receiver from an extended configuration in which the distal microneedle patch abutting surface is spaced from the receiver to a depressed configuration, and wherein the receiver comprises a force limiter associated with the plunger configured to prevent movement of the plunger from the extended configuration to the depressed configuration until a pre-determined threshold input force has been applied to the plunger by the user, in which the force limiter is configured to trip once the predetermined threshold input force is reached to uncouple input force applied by the user from a resultant load applied to the object.

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