Title of Invention

A DEVICE FOR IMPACTING A PENETRATING MEMBER AGAINST THE STRATUM CORNEUM AND A METHOD FOR THE SAME

Abstract

A device (10) for impacting a penetrating member (92) against the stratum corneum (90) comprising: a body (12) having a first end (40) and a second end (42); said first end (40) adapted to receive the penetrating member (92); a piston (14) slidably disposed within said body (12) for impacting the penetrating member (92) against the stratum corneum(90); an impact spring (20) adapted to provide an impact force to the piston (14) and bias said piston (14) out of said first end (40) of said body (12); wherein said impact spring (20) is energized when said piston (14) is further disposed within said body (12); a latching mechanism (22, 26, 28) wherein said latching mechanism releasably engages said piston (14) with said body (12) after said piston (14) has been sufficiently disposed within said body (12); and a releasing mechanism (16, 46) for disengaging said latching mechanism (22, 26, 28) whereby said impact spring (20) impacts said piston (14) against the penetrating member (92) forcing the penetrating member (92) into said stratum corneum (90); wherein said penetrating member does not pierce said stratum corneum to a depth greater than 500 μm.

Full Text

TECHNICAL R6L0 [0001 ] The invention relates to an apparatus and methodJor?»pp»ytog a penetrating membw to the stratum comeum layer ofthe skin oy impact, arad more particularly, the invention relates to the use erf an impact device to reproducibly penetrate the stratum comeum with a penetrating member such as a nrweroprotrusion array for tnvtsdermal de**ery or tempting of an agent. BACKOAOUHO AftT §MGt§ Interest in the percutaneous or traneriemtat delivery of peptides and proteins to the human body oonfnues to grow with the inoeating number of medtoa% useful peptides and proteins becoming avatfatete in targe c»uantjt»$ and pure form. The transdermai delivery of peptkles and proteins still faces significant probtems. In many instances, the rate of delivery or t!ux of potypepttdes through the skin is insufficient to produce a tfesfeed therapeutic effect due to theif large site and molecular weight In addrt*on, peijfMViides and fitolems are eastiy degmtetf during and aMer penetration into the skin, prior to teacnm^tafgeloete yhewiee, the pewive fremoterme) nun of many low motecutar weight oompoun* is too N**Hled to ^ thetapeoticeJIr eWecttve. {0(MR^ One meWwd of mcfeasmg s^ie Mtnadeniiel defcvofy of slants reties on pre-treattng the ekm with, or os-deiwenng wi»i the oeneNwei agan*, a ston penneaiSen enhancer. A petviteasion enhenost miiwtaiipe, wnen aflpead to a bodyewrtewe thfougjh which the egent is detweree), ewhaweee tt*e ttfe^wdeww flux ol the agent such as by incfeasing tie pewnselecbwty ansVor permeability of the body surface, and/or reducing the degNriasfen of the agent. fMt4] Another tiethod of inoeasing the agent flux kwefcam *» application of an electric cvtrrent across the body surface referred to as "e "Electootransporr refers generally to the passage of a bwneftciaJ agent, e.g., a drug or drug precursor, through a body surface, such as skin, mucous membranes, naiis, and the .ike. The transport of Hie agent is induced or enhanced by the application of an electrical potential, which results in the app*c«ronofetectiTCCumHit,wh^ agent Eiectrotraflseort detwevy generally increases agent delivery and reduces potypefftMe degradation during transdermal detfvefy [0005] There atso have been many attempts to mechanicatty penetrate or disrupt the skin in order to enhance the tranedefma) flux. See tor exempts. U.S. Pater* Nee 5,879,326 ieeue to GodefceJi. et at., 3,814,087 issued to Gancterton, et A. 5.279,544 issued to Gross, at at., 5,250,023 issued to Lee, et al, 3,964,482 issued to Gm*m, et at., Reissue 26,637 ts&uad to Kiavifc, et al., and PCT PuWir.atior Nes. WO 96/371&5f WO 96/37256. WO 96/17648, WO 97/03716, WO 98/11937, WO 98/00193, WO 97/4*440, WO 97/48441, WO 97/48442, WO 98/00193. WO 99/84580, WO 8*98087, WO 98/29898, and WO 98/29385. These deviees use piercing aktments of various shapes and sees to pierce the outermost layer (i.e., the stratum comeum) of the skin. The penetrating elements disclosed in maee relevance* geiraaWy eartend perpendicularly from a thin, fiat member, such as a pad or shaet. The penetrating elements m some of these devices are extremely smaH, some having dimensions (i.e., a rmcrofeiade length and width) of only about 25 - 400 /imamiam»wob*ewknw«ofonJyaboal5-50^m. QtN* peneteoting eJsments are ttetam needles hawing diameter* of afeet* i0«#morlessand lengths of about SO-100 ^m Tliaae tiny stratum coirm** fii*tatqlciM*% eiemanta a#e meant to make caneepondtngV s«^ micioeliis/mciscuts in the ^atum ca-neum tor enhanced twnadafmat agent daiwaty iwaUwwigh in mwiy iwatancet. mm f^woslrWmicrocuts in the stratum oume^n hex a length of less Wm% ISO jum mnd a width \*«Ncn is suliatanfia% siwsiaf tNan their iangth (0888] Ston pentratoirj devioss are used to panawte the outermost layer of the skin. i.e.. etratuni comeum, w.th a p pathways through wtvch an agent such as a drug can be introduced, i.e., delivered, or an agent such as a body anatyte can be wttwkewn. i.e.. sampled. The aartorated skin provides improved flux for sustained agerrt delivery or sampling through the skin. [0897] When n.iaoprotiasion arrays are used to improve delivery or sampling of agents through the skm, consistent, complete, and rapeatebte penewanon is aesuea. ManUoiappRtiion (P#MHIPOTPIHMRS mtcroprotrusiont protruding from its skin contacting side often rwutts in significant variation in puncture depth across the length and width of mo patch, in addition, manual application mulls in large variations in puncture depth between applications due to the manner in wtucn the user applies the array. Accordtngly. it would te desirable to be afefe to apply a m»croprotrusk>n array to the stratum corneum with an automatic device, vxtwch provide* »n a consistent and wpeatatote manner, stratum comeum piefcing not ©my over the length and width of the rrecraprotrusion array but eiso from application of one microprotrustfn at ray to the next. fOStti Some krKwnspnngtoactedapfjtM^tor device for ctehvery of lancets for body fluid {e.g., blood) sampling am described in WO 99/26539 and WO 97/42816. However, these devices are difficult to use because they retire two har«teu cc(*mg of the app^ In particular, the Known spring loaded lancet applicators require either two sections of the device to be pulled apart for cocking or require one part of the device to be twisted with respect to another part of the device for cocking. In both of these mobons two handed cocking operation is required Many ot me paints ustng these devtces possess neither the strength nor the manual dexterity to cock these known applicator device* [POM] Accordingly, it wouttbe desiraoie to provide a spring loaded mmlitmtnr for * skin p«r»e*et«g member whieh is ; opeirttoo of the veer and MhioH requires a minime* hand s*awajti tor cocking. CI9CL(MMJPI6 OF 1148 ajajaajffioai itm%] The p»esef>t »nveot*on relates to an afipJicator for appiying » peaetratirHj memtef to the stratum comeum wilh impect. The pewetfatmg member may be a mic«^otrusk>n array v^ich is used to improve transport of an agent across, me ster. The apptealor tnc4udes a oocfcfftg mechanism which allows one handed cooking operation, tlie cocking mechanism rsquires minknal hand strength and dexterity since tfce cocking force can be applied by a user's arm. I»11] to aeco«ia impacting a penetrating member against the stratum comoum includes a device body for abdication of a penetrating member to the stratum corneum, a piston mounted within the device body tor impacting the penetrating member against the stratum corneum, an impact spring between tie piston and the device body for providing an impaet force to the piston, and a cocking mechanism for cocking and locking me pwtton in a cocked position by compressing the device body and piston together using a compressing force which can be easily performed with one hand. [0012] In accordance with an additional aspect of the present invention, a device for impacting a .nicrobtede array against the stratum comeum includes a device body, a piston mourned within the device body, the piston having a microbiacte array applying surface, an impact spring acting between the device body and the piston to impact the stratum corneum with the microbfacte array, fc cap mavably mounted on the device body, a hold down spring acting between the device body and the cap, a coefcing mechanism for cocking and looking the piston in a cocked position with one hand by compressing the device body and piston together, and a piston release lor releasing the piston from the cocked position to impact the stratum corneum with the rrwcroWade array when the hold down soring is compassed. (0019] In acoofctanoe with a further aspect of the invention, a method of cocking a device tor wnpacting» penetrating member agatast the stratum oomeum includes the steps of moving a piston to a cock** peeiSon w«h r«ep*rt to a dvik* tody by complies^ with onry one hand, and locking the piston in the cocfee* pottfteft w*h the one hand. f09*«| In a^xcfO^Mx* wrth an a&jitoria4 aspect tf of impacting a penetrating member against the stratum corneum includes providing an impacting device having a device body, a piston, and an impact spring; cocking the impacting device using ortry one hand by moving the piston to a cocked position with respect to the device body and hacking the piston in the cocked position, mounting a penetrating member on the piston; and releasing the pston to impact the penetrating member against the stratum corneurn BRIEF DESCRIPTION OF THE DRAWINGS The invention wiii row be described in greater detail with reference to the preferred embodiments illustrated in the accompanying drawings, in which like elements bear like reference numerals, and wherein: FIG. 1 is side cross sectional view of an applicator device in an initial configuration prior to cocking; FIG. 2 is a side cross sectional view of the applicator device of FIG. 1 in a cocked position with a patch retainer attached to the applicator; FIG. 3 is a side cross sectional view of the applicator device ot FIG. 1 with the patch retainer of FIG. 2 after the piston has been released to apply the patch; FIG. 4 is an exploded perspective view of the applicator device of FIG. 1, FIG 5 is a perspective view of an alternative embodiment of an applicator device, FIG. 6 is a side view, partially in section, of the applicator device of FIG. 5; and FIG. 7 is a perspective view of a portion of one example of a microprotrusion array. MOOES FOR CARRYING OUT THE INVENTION [0015] The applicator device of the present invention is used for repeatabte impact application of an array of microprotrusions to the stratum corneum in conjunction with transdermal therapeutic agent (e.g., drug) delivery or transdermal body analyte (e.g.. glucose) sampling. Although the applicator device 10 is described for use with a certain type of microprotrusion array, it should be understood that the applicator device may also be used with other types of stratum corneum micropenetrating members. The applicator device can be used by patients having neither the hand strength nor the manual dexterity to cock other types of spring-loaded applicator devices. Further, the applicator device can be cocked and released with one- handed operation v.'hicli provides certain advantages, for example, allowing a patient to apply a drug delivering mjcroprotrusion array tor local therapy on a site on the patient's own arm [0016] Turning now to the figures, FIG. 1 illustrates applicator device 10 including a device body 12 and a piston 14 movable within the device body. A cap 16 is provided on the device body 12 for activating the applicator to impact the stratum corneum with a microprotrusion array (not shown in FIG 1). An impact spring 20 is positioned around a post 22 of the piston 14 and biases the piston downward with respect to the device body 12. The piston 14 has a tower surface 18 which is substantially planar, slightly convex, or configured to a body surface (i.e , a specific skin site). The lower surface 18 of the piston 14 causes a microprotrusion array or a transdermal patch containing a microprotrusion array to impact and pierce the stratum corneum. (0017] FIG. 1 shows the piston 14 in an uncocked position, while FIG. 2 shows the piston in the cocked position. When the applicator device 10 is cocked, the piston 14 is pressed up inside the device body 12 and locked in place by a locking mechanism. The locking mechanism includes a catch 26 on the post 22 and a flexible finger 28 on the device body 12 having a corresponding latch 30. (0018] As the piston M is moved toward the device body 12 compressing the impact spring 20. the catch 26 flexes the finger 28 and snaps over the corresponding lajch so of the flexible finger 28. The cocking step is performed by a single compression motion which both cocks and locks the piston 14 in the cocked position. This cocking step is easily performed with only one hand by compressing the applicator device 10 between a user's hand and another surface (e.g. a table top) (0019] FIG. 2 illustrates the applicator device 10 with the piston 14 in a cocked configuration. As shown in FIG. 2. in the cocked position, the catch 26 and latch 30 on the piston 14 and device body 12 are releasably engaged preventing downward motion of the piston in the device body. [0020] FIG. 2 also illustrates a patch retainer 34 mounted on the device body 12. The retainer 34 has an annular shape with a first end 40 which is configured to engage the device body 12. A second end 42 of the retainer 34 provides a stratum comeum contacting surface. A patch 44 is mounted between the first and seconci ends 40, 42 of the retainer 34 The patch 44 is suspended in the retainer 34 Although the manner in which the patch 44 is mounted in the retainer 34 and the location ol the mounted patch 44 within the retainer 34 may vary (tor example, the patch 44 may be positioned adjacent the second end 42 of the retainer 34) it is preferred to mount patch 44 recessed some distance from both ends 40 and 42 (as shown in FIG. 1) in order to avoid inadvertent contact of the patch microprotrusions with other objects (e.g., the fingers of the user). [0021] According to one example, the patch 44 is connected by frangible sections of patch base material to an annular ring of patch material which is adhered to the retainer ring 34. The patch 44 is separated from the retainer ring 34 by the downward force of the piston 14 Alternatively, the patch may be releasably attached to the piston 14 or positioned on the skin beneath the piston. [0022] The applicator device 10 can be used with a patch 44 which generally includes a nwcrop.'Otrusion array, an agent reservoir, and a backing However, the applicator device 10 may also be used with a microprotrusion array without an agent reservoir. In thts case, the microprotrusion array is used as a pretreatment which is followed by the application of an agent with a separate transderrnai agent delivery or sampling device. Alternatively, the microprotrusion array may incorporate the agent as a coating on the microprotrusions, e.g. tor delivering a vaccine intradermally. The application device 10 may also be used for impacting other micropiercing elements against the stratum comeum, for example those disclosed in Godshall et ai, U.S. Patent 5,879,326 and Zuck WO 99/29364, the disclosures of which are incorporated by reference herein. [0023] In addition to being able to cock the device 10 with only one hand, device 10 is also designed to be operated (i.e., to cause release of the spring- loaded piston 14 and thus causing the patch 44 to impact the skin) using only one hand. The activation ot the applicator device 10 by releasing the locking mechanism is performed by downward force applied to the applicator cap 16 while the second end 42 of the applicator device is held against the skin. The cap 16 is biased upwards by a hold down spring 24 which is positioned between the device body 12 and the cap. The cap 16 includes a pm 46 extending downward from the cap. When the cap 16 is pressed downward against the bias of the hold down spring 24, the pin 46 contacts a ramp 48 on the flexible finger 28 moving the flexible finger outward and disengaging the latch 30 of the flexible finger 28 from the catch 26. This releases the piston 14 and the piston moves downward impacting the stratum corneum with the patch 44. [0024] FIG. 3 illustrates the applicator device 10 after ths device has been released and a patch has been applied to the stratum corneum The hold down spring 24 is selected such that a predetermined hold down force must be achieved before the device is released The hold down force causes the stratum corneum to be stretched by the second end 42 of the retainer 34 so that the skin is under optimal tension at the time the patch 44 impacts the skin. The hold down force applied by the hold down spring 24 is preferably selected to cause the second end 42 to apply a tension to the skin in the range of about 0.01 to 10 megapascais (MPa), more preferably about 0.05 to 2MPa. [0025] A balance between the hold down spring 24 and the impact spring 20 allows the cocking of the piston 14 by pressing on the cap 16 without causing the finger 46 to release the locking mechanism. The impact spring 20 is selected to achieve a predetermined impact which is appropriate for a particular patch to provide the desired penetration. The selection of the impact and hold down springs is described further in U.S. Provisional Patent Application Serial No. 60/240,307 filed on even date herewith, which is incorporated herein by reference in its entirety. (0026] The retainer 34 is attached to the device body 12 after cocking of the piston 14. The retainer 34 is attached by a snap in connection requiring less force to snap m than the force required to release the piston. The retainer 34 may also be attached to the device body by a bayonett fitting or a slide-on fitting which allows the retainer 34 to slide into the device body 12 in a direction normal to the axis of the applicator. [0027] FIG. 4 illustrates the cap 16, device body 12, and piston 14 in an exploded perspective view. As shown «n FIG. 4. the piston 14 includes piston retainer tabs 52 which engage a lower rim 54 (FIG. 3) of the device body 12 and prevent the piston from being expelled from the device body. In addition, the cap 16 includes retainer tabs (not shown) which similarly engage an upper rim 58 (FIG 3) of the device body 12 and prevent the cap from coming off of the body. [0028] FIG. 4 also illustrates an optional rotational locking arrangement which allows the cap 16 to be rotated io a locked position at which activation of the applicator is not possible because the pin 46 is not aligned with the flexible finger 28. An indication of the locked or unlocked position of the cap 16 is provided through a window 60 in the cap. When the cap 16 is at positions other than the unlocked position, the pin 46 is not aligned with the ramp 48 on the flexible finger 28 and thus, the applicator cannot be released. While this optional locking feature prevents inadvertent activation of the applicator device 10, the re'ative rotational motion of the body 12 and the cap 16 generally requires the use of both hands, which in some cases is less desirable. [0029] FIGS. 5 and 6 illustrate an alternative embodiment of an applicator 80 having a different shape and somewhat different cocking arrangement which also achieves the desired result of simple one handed cocking operation. According to this embodiment, the user grasps an outer cylinder 81 which acts as a handle for the device. A piston 82 is slidabty engaged within the cylinder 81 An impact spring 83, shown in compression in FIG. 6 biases thejaisten 82 away from the top or skin distal end of cyclinder 81. A releasabie catch mechanism 84 (not shown in detail in FIG 6) is provided whereby depression of button 85 causes latchj&to retract thereby enabling compressed spring 83 to move piston 82 downwardly (i.e. , in a direction towards the skin). Slidably engaging the skin proximal end of cyclinder 81 is a middle housing 87 having an indicator notch 96. Threaded to housing 87 is lower housing 88 which has a generally annular shape. A retainer 93, whose function is described in detail in U.S. Provisional Patent Application Serial No. 60/240,379 filed on even date herewith and incorporated herein by reference is screwed onto the skin proximal end ot cyclinder 81. Within retainer 93 is an impact head 34 which is attached to piston 82. [W,Q^J}SSSLS^ is adapted to hold, on its skin proximal suface, a patch having a plurality ot microprotrusions (the patch is not shown m FIG 6). A hold down spring 95, shown in compression in FIG. 6, is provided between cyclinder 81 and middle housing 87r Hold down spring 95 compresses when the user grabs cylinder 81, places edge 89 against the skin site to be pierced, and presses the device 80 against the skin site As spring 95 is compressed, notch 96 becomes aligned with the lower edge of band 97. In this alignment, the hold down spring 95 is in a predetermined compression which provides the necessary hold down force and skin stretching at edge 89. Once the notch 96 is aligned with the lower edge of band 97, the operator simply presses button 85, which releases latch 86_which in turn releases piston 82 and head 94, causing head 94 to impact the microprotrusion member against the patient's skin. [0030] The applicator devices 10 and 80, according to the present invention have been described with respect to an upright orientation in which the patch 44 is applied Irorn a piston side of the device which is illustrated at the bottom/skin proximal end of the devices in the figures It should be understood that the applicator devices may be used in other orientations (i.e , sideways and upside down) as long as the device is properly oriented against the skin site to be pierced. [0031] FIG. 7 illustrates one embodiment of a stratum corneum penetrating member for use with the present invention. FIG. 7 shows a plurality of microprotrusior.s in the form of microblades 90. The microblades 90 extend at a substantially 90° angle from a metal sheet 92 having openings 94. The sheet 92 may be incorporated in an agent delivery patch or an agent sampling patch which includes an agent reservoir and an adhesive for adhering the patch to the stratum corneum. Examples of agent delivery and sampling patches which incorporate a microprotrusion array are found in WO 97/48440, WO 97/48441. WO 97/48442. The microprotrusion array of FIG 7 without a reservoir may also be applied alone as a skin pretreatment. [0032] The teifn microprotrusion" as used herein refers to very tiny stratum corneum piercing elements typically having a length of less than 500 nm, and preferably less than 250 Mm, which pierce through the stratum corneum into the underlying epidermis layer or epidermis and derrnis layers. However, the microprotrusions should not penetrate so deep into the dermis layer as to cause bleeding. In order to penetrate the stratum corneum, the microprotrusions preferably have a length of at least 10 urn, more preferably at least 50 urn In general, microprotrusions penetrate the skin to a depth of no more than about 500 urn and preferably less than about 400 urn. The microprotrusions may be formed in different shapes, such as needles, hollow needles, blades, pins, punches, and combinations thereof [0033] The tern "microprotrusion array' as used herein refers to a plurality of microprotrusions arranged in an array for pierce 3 the stratum corneum. The microprotrusion array may be formed by cutting a plurality of blades from a thin metal sheet and folding each of the blades out of the plane of the sheet to form the configuration shown in FIG. 7. The microprotrusion array may also be formed in other known manners, such as by connecting multiple strips having microprotrusions along an edge of each of the strips. The microprotrusion array may include holiow needles which inject a liquid formulation. [0034] Examples of microprotrusion arrays are described in US. Patent Nos. 5,879,326 issue to Godshall, et al., 3.814,097 issued to Ganderton. et al., 5,279,544 issued to Gross, et a!., 5,250.023 issued to Lee, et al., 3,964,482 issued to Gerstel, etal.. Reissue 25.637 issued to Kravitz, et al., and PCT Publication Nos. WO 96/37155, WO 96/37256, WO 96/17648. WO 97/03718, WO 98/11937, WO 98/00193. WO 97/48440, WO 97/48441, WO 97/48442, WO 98/00193, WO 99/64580, WO 98/28037, WO 98/29298, and WO 98/29365. all of wh»ch are incorporated herein by reference in their entirety. [0035} The device of the present invention can be used in connection with agent delivery, agent sampling, or both. In particular, the device of the present invention is used in connection with transdermal drug delivery, transdermal analyte (e.g , glucose) sampling, or both. Trar.sdermal delivery devices tor use with the present invention include, but are not limited to passive devices, osmotic devicos, pressure-driven devices, and electrotransport devices Transderma! sampling devices for use with the present invention include, but are not limited to. passive devices, negative pressure driven devices, osmotic devices, and reverse etectrotransport devices. The transdermal devices of the present invention may be used in combination with other methods of increasing agent flux, such as skin permeation enhancers. [0036] The device of the present invention may be used with a microprotrusion array included in a transdermal delivery or sampling patch having adhesive for attaching the patch to the skin. Alternatively, the microprotrusion array and delivery or sampling patch may be two separate elements with the microprotrusion array used for pretreatment prior to application of the delivery or sampling patch. [0037) While the invention has been described in detail with reference to the preferred embodin.ents thereof, it will be apparent to one skilled in the art that various changes and modifications can be made and equivalents employed, without departing from the present invention. We Claim: 1. A device (10) for impacting a penetrating member (92) against the stratum corneum (90) comprising: a body (12) having a first end (40) and a second end (42)j' said first end (40) adapted to receive the penetrating member (92); a piston (14) slidably disposed within said body (12) for impacting the penetrating member (92) against the stratum corneum(90); an impact spring (20) adapted to provide an impact force to the piston (14) and bias said piston (14) out of said first end (40) of said body (12); wherein said impact spring (20) is energized when said piston (14) is further disposed within said body (12); a latching mechanism (22, 26, 28) wherein said latching mechanism releasably engages said piston (14) with said body (12) after said piston (14) has been sufficiently disposed within said body (12); and a releasing mechanism (16, 46) for disengaging said latching mechanism (22, 26, 28) whereby said impact spring (20) impacts said piston (14) against the penetrating member (92) forcing the penetrating member (92) into said stratum corneum (90); wherein said penetrating member does not pierce said stratum corneum to a depth greater than 500 (am. 2. The device as claimed in claim 1, wherein said body (12), and piston (14) are adapted to be releasably engaged by 4JV single hand. 3. The device as claimed in claim 1, wherein the latching mechanism comprises interengaging latch member (26, 28) on the body (12) and piston (14). 4. The device as claimed in claim 3 optionally including a flexible finger (28) on said body (12) and a stop (30) on said piston (14) wherein said flexible finger (28) and said stop (30) comprise said interengaging latch members (26, 28). 5. The device as claimed in claim 1, wherein said releasing mechanism (16, 46) is adapted to release said piston (14) after a force is exerted upon said releasing mechanism (16, 46). 6. The device as claimed in claim 5, wherein said latching mechanism (22, 26, 28) and said piston (14) releasing mechanism (30) are adapted to allow one handed operation of each mechanism. 7. The device as claimed in claim 5, optionally comprising a cap_IW>} movably mounted on said body (12) for activating the|^j5asing mechanism (26, 28) when said cap (16) moved onto said body (12). 8. The device as claimed in claim 7 optionally comprising a hold down spring (24) disposed between the body (12) and the cap (16) for resisting the activation of the release mechanism (26, 28) until said hold down spring (24) has been sufficiently energized such that said hold down spring (24) exerts a predetermined hold down force. 9. The device as claimed in claim 7 optionally comprising a lock mechanism (58) for preventing movement of said cap (16) relative to said body (12) whereby activation of the release mechanism (16, 46) is prevented. 10. The device as claimed in claim 9 optionally comprising an indicator (60) for indicating when said cap (16) is in said locked position. 11. The device as claimed in claim 1, wherein said latciusg. mechanism (22) automatically locks said piston (14) in a cocked position with respect to said body (12) when said pistion (24) has been sufficiently disposed within said body (12). 12. The device as claimed in claim 1 wherein said piston (14) comprises an application surface having a shape and size which provides for an effective application of a specific patch (44) to be impacted. 13. The device as claimed in claim 12 wherein said application surface has a shape selected from the group consisting of a convex shape, a substantially planar shape and a shape configured to mate with a predetermined body surface site. 14. A device (80) for impacting a microblade array against the stratum corneum the device comprising: a device body (81); a pistion (82) mounted within the device body (12), the piston (14) having a microblade array applying surface (90); an impact spring (83) acting between the device body (81) and the piston to impact the stratum corneum (90) with the microblade; a cap (16) movably mounted on the device body (81); a hold down spring (95) acting between the device (81) and the cap (16); a latching mechanism (86) for locking the piston (82) in a cooked position with one hand by compressing the device body (81) and piston (82) together; and a piston release (83) for releasing the piston (82) from the cocked position to impact the stratum corneum (90, 92) with the microblade array (90) when the hold down spring (95) is compressed. 15. The device as claimed in claim 14, wherein the piston release (82) comprises a release finger (93). 16. The device as claimed in claim 15, wherein the latching mechanism (86) comprises a flexible finger (85) and a stop (84). 17. The device as claimed in claim 14, wherein the hold down spring (85) resists the activation of the piston (82) release until a predetermined hold down force is reached. 18. A method of cocking a device for impacting a penetrating member against the stratum corneum, the method comprising: moving a piston to a cocked position with respect to a device body by compressing the piston and device body; and locking the piston in the cocked position with said compressing, whereby the device can be cocked and locked using only one hand. 19. The method as claimed in claim 18, wherein the piston is cocked by moving the piston along a device axis and the piston is deployed by depressing an activating cap along the device axis. 20. The method as claimed in claim 18, wherein the piston is locked in the cocked position automatically. 21. The method as claimed in claim 18, wherein the piston is locked in the cocked position manually. A device (10) for impacting a penetrating member (92) against the stratum corneum (90) comprising: a body (12) having a first end (40) and a second end (42); said first end (40) adapted to receive the penetrating member (92); a piston (14) slidably disposed within said body (12) for impacting the penetrating member (92) against the stratum corneum(90); an impact spring (20) adapted to provide an impact force to the piston (14) and bias said piston (14) out of said first end (40) of said body (12); wherein said impact spring (20) is energized when said piston (14) is further disposed within said body (12); a latching mechanism (22, 26, 28) wherein said latching mechanism releasably engages said piston (14) with said body (12) after said piston (14) has been sufficiently disposed within said body (12); and a releasing mechanism (16, 46) for disengaging said latching mechanism (22, 26, 28) whereby said impact spring (20) impacts said piston (14) against the penetrating member (92) forcing the penetrating member (92) into said stratum corneum (90); wherein said penetrating member does not pierce said stratum corneum to a depth greater than 500 μm.

Documents:

452-KOLNP-2003-CORRESPONDENCE 1.1.pdf

452-KOLNP-2003-FORM 15.pdf

452-kolnp-2003-granted-abstract.pdf

452-kolnp-2003-granted-assignment.pdf

452-kolnp-2003-granted-claims.pdf

452-kolnp-2003-granted-correspondence.pdf

452-kolnp-2003-granted-description (complete).pdf

452-kolnp-2003-granted-drawings.pdf

452-kolnp-2003-granted-examination report.pdf

452-kolnp-2003-granted-form 1.pdf

452-kolnp-2003-granted-form 18.pdf

452-kolnp-2003-granted-form 2.pdf

452-kolnp-2003-granted-form 26.pdf

452-kolnp-2003-granted-form 3.pdf

452-kolnp-2003-granted-reply to examination report.pdf

452-kolnp-2003-granted-specification.pdf

452-kolnp-2003-granted-translated copy of priority document.pdf

452-KOLNP-2003-PA.pdf