Abstract
A device that may be placed on a biological barrier can be used to perforate the biological barrier for a variety of purposes such as cosmetic, scar treatment or for the delivery of active agents. A flexible substrate has a first side and a second opposing side and a plurality of micro-penetrator arrangements each comprising a head and a first and second projection, for penetrating a biological barrier, extending from the head. The first and second projection at least partially extend through the flexible substrate towards the first side. The head comprises an elongate arm for spacing apart the first and second projections. A force is applied to the second side causing flexing of the flexible substrate and pushing the projections into communication with a biological barrier.
Claims
1. A device for penetration of a biological barrier, the device comprising: a flexible substrate having a first side and a second opposing side; and a plurality of micropenetrator arrangements each comprising a head and a first and second projection, for penetrating a biological barrier, extending from the head; wherein the first and second projection at least partially extend through the flexible substrate towards the first side; and wherein the head comprises an elongate arm spacing apart the first and second projections.
2. A device according to claim 1, wherein the flexible substrate comprises a different material to the micropenetrator arrangement.
3. A device according to claim 1, wherein the first and second projections project perpendicular to the head.
4. A device according to claim 3, wherein the first and second projections project from the first side.
5. A device according to claim 1 wherein the head is embedded and encapsulated in the substrate.
6. A device according to claim 1 wherein the arm and the first and second projections are formed of a single elongate bent element.
7. A device according to claim 1 wherein the head and first and second projections are formed of a metallic material.
8. A device according to claim 1 wherein the arm comprises a first arm and the head further comprises a second arm, wherein the first and second arm are positioned in the form of a cross.
9. A device according to claim 8, wherein the first and second projection project from the first arm, and a third and fourth projection project from the second arm.
10. A device according to claim 8, wherein the first and second arms comprise an overlap zone of overlapping first and second arms, and the first and second arms are joined at the overlap zone, and the first and second arms are mutually perpendicular.
11. (canceled)
12. A device according to claim 1, wherein a first and second adjacent micropenetrator arrangement are independent of each other.
13. A device according to claim 12, wherein the elongate arm is of the first micropenetrator arrangement is orientated between the parallel to and perpendicular to the elongate arm of the adjacent second micropenetrator arrangement.
14-17. (canceled)
18. A device according to claim 1, wherein the substrate comprises a leading edge and a trailing edge, and the leading edge is curved to generally confirm to the leading edge of a finger.
19. A device according to claim 1, wherein at least a portion of the first and/or second projection comprise a curved portion.
20. A device according to claim 19 wherein the curved portion comprises a plurality of repeating curved portions.
21. A device according to claim 1, further comprising a supplementary projection arranged such that at least one of the first and/or second projection are in communication with the supplementary projection for penetration of a biological barrier.
22. A device according to claim 21, wherein the supplementary projection is intertwined with at least one of the first and/or second projection.
23. (canceled)
24. A device according to claim 1, wherein the first side of the flexible substrate carries a drug and/or biologically active material therein.
25-64. (canceled)
Description
[0134] Aspects of the present invention will now be described by way of example only with reference to the accompanying drawings in which:
[0135] FIGS. 1a and 1b show an exemplary embodiment of a device according to aspects of the present invention prior to activation in FIG. 1a and during activation in FIG. 1b.
[0136] FIG. 2a is a schematic representation of a micropenetrator arrangement without the substrate shown for clarity purposes according to an exemplary embodiment of the present invention, FIG. 2b is a schematic upper perspective view of a device according to an exemplary embodiment of the present invention, and FIG. 2c is a schematic underside perspective view of the embodiment as presented in FIG. 2b.
[0137] FIGS. 3a and 3b are an alternative exemplary embodiments of the present invention in a configuration prior to activation as shown in FIG. 3a and in a configuration during activation as shown in FIG. 3b.
[0138] FIG. 4 is a schematic side view of an exemplary embodiment of the present invention with the micropenetrator arrangement during activation.
[0139] FIGS. 5a and 5b are further exemplary embodiments of the present invention in non-activated and activated configurations as shown in FIGS. 5a and 5b respectively.
[0140] FIGS. 6a and 6b are further exemplary embodiments of the present invention in the non-activated and activated configurations according to a further exemplary embodiment.
[0141] FIG. 7 is a schematic side view of an exemplary embodiment of an aspect of the present invention.
[0142] FIGS. 8a and 8b are further exemplary embodiments of an invention according to aspects of the present invention.
[0143] FIG. 9 is a further exemplary embodiment of the present invention.
[0144] FIG. 10 is a schematic plan view of a further exemplary embodiment of an aspect of the present invention.
[0145] FIG. 11 is a further schematic representation of a device according to an exemplary embodiment relative to a finger.
[0146] Referring to FIG. 1a a device according to an exemplary embodiment of the present invention is presented. The device 2 is presented prior to activation and contact with a biological barrier 5. The device 2 comprises a flexible substrate 3 having a biological barrier contact surface 4. In the embodiment presented a supplementary layer 6 is provided on the second opposing side 8 of the flexible substrate. Presented in this embodiment for clarity purposes are two micropenetrator arrangements 10 each comprising a head 12 and first and second projections 14, 16. The projections extend to a tip 18 and in the form presented are sharpened to a point through cutting the respective projections at an angle non-perpendicular to the longitudinal length of the respective projections. The head 12 comprises an abutment surface 20 which may abut the second side 8 of the flexible substrate 3. In the embodiment presented, due to the provision of the supplementary layer 6 the head 12 is encapsulated within the layer 6. Also in the embodiment presented, the projections 14, 16 project from the first side 4 ready for penetration into the biological layer 5. Such projections may be retained within the flexible substrate 3 adjacent to the first side 4 such that upon application of a force causes the tips 18 to penetrate through the first side 4 and into the biological barrier 5.
[0147] The layer 6 presented in FIG. 1 in combination with the projections 14, 16 extending towards the first side 4 of the flexible substrate 3 retain the micro-penetrator arrangements 10 in position.
[0148] As shown in FIG. 1b, as a force is applied as indicated by arrow 22 a micro-penetrator arrangement 10 is forced downwardly through the biological barrier 5. Due to the flexibility inherent in the flexible substrate 3 the depth of penetration by micropenetrator 10 is different to an adjacent micropenetrator arrangement. Accordingly, treatment can be tailored to the precise location required. As also shown in FIG. 1b, the force applied in the direction indicated by arrow 22 causes the micropenetrator arrangement 10 to enter straight into the biological barrier 5. Side-to-side deflection is minimised due to the provision of the head 12 and plurality of projections 14, 16 extending therefrom. Stability is further improved through the provision of additional projections extending from the head as described in more detail with respect to FIG. 2. The flexible substrate 3 is preferably elastomeric as is the supplementary layer 6 if present. The force identified in the direction indicated by arrow 22 can be supplied by a roller, a vibrator or any other form of power, and can be used to actuate either a small number of micropenetrator arrangements 10 or a single one. Alternatively, a large number may be activated in parallel or all the micro-penetrators in a single device. The micropenetrators may be driven by the force in sequence or at random, and over any time period.
[0149] The head 12 and the first and second projections 14, 16 are beneficially formed of a single piece of material. The material is preferably metallic and the first and second projections 14, 16 extend substantially perpendicular to the head 12. The micropenetrator arrangement as presented in FIG. 1 is in the form of a staple where the projections 14, 16 are of equal length however it will be appreciated that this is not essential. Referring to FIG. 2, an exemplary micropenetrator arrangement is presented. The micropenetrator arrangement 10 comprises a head 12 in the form of a cross comprising a first arm 26 and second arm 28. First and second projections 14, 16 extend from the distal ends of the first arm 26. From the distal ends of the second arm 28 third and fourth projections 30, 32 extend. The benefit associated with additional projections extending from the head 12 is the further stability provided. It will be appreciated that a configuration of three or more projections provides improved stability. In the embodiment presented, the arms 26, 28 overlap at an overlap zone 34 and are beneficially adhered at this point. First and second arms 26, 28 are mutually perpendicular.
[0150] Referring to FIG. 2b, the head 12 can be seen abutting the second side 8 of the flexible substrate 3. In bottom perspective view as shown in FIG. 2c, the projections 14, 16, 30, 32 project through the flexible substrate 3 for penetration into a biological barrier 5.
[0151] Referring now to FIGS. 3a and 3b an embodiment of the present invention is presented wherein the micropenetrator arrangement comprises two projections 14, 16 and head 12. It will be appreciated, however, that such a micro-penetrator arrangement 10 has been presented as an example only and a single projection may be utilised with a head 12. The single projection may be at least partially curved. Provided is a formation 36 positioned above the head 12. The formation 36 may be adhered to the head 12 and also to the second side 8 of the flexible substrate 3. The provision of this formation reduces the lateral freedom of movement of the micropenetrator 10. Referring to FIG. 3b the activation sequence is shown pushing the micropenetrator 10 into the biological barrier 5 and shown is the minimal side-to-side deflection of the first and second projections 14, 16. It will be appreciated that the formation 36 protrudes from the second side 8 and in the embodiment shown is in the form of a dome. It will also be appreciated, however, that other shape formations are possible. It will further be appreciated that it is beneficial that the formation 36 comprises a material of higher rigidity than the flexible substrate 3.
[0152] Referring to FIG. 4, a further exemplary embodiment of the present invention is presented. Again, a micro-penetrator arrangement 10 has been shown comprising a configuration of a head 12 and first and second projections 14, 16. It will be appreciated that the head may take a variety of forms and any number of projections may be utilised.
[0153] In the embodiment of FIG. 4 the head 12 is provided within a layer 40 which is flexible. In the embodiment shown the head 12 is provided within the layer 40 however it will be appreciated that the head 12 may be provided abutting the layer 40 such that the projection(s) extends therethrough. Provided intermediate the layer 40 and the flexible substrate 3 is a cavity 42 that may be filled with a liquid. Channels 44 may extend through the flexible substrate 3 through which the projections extend providing a flowpath through the flexible substrate 3 to the first side 4. Upon actuation as shown in FIG. 4, fluid may travel from the cavity 42 through the channels 44 and into the biological barrier 5. The increase in pressure caused by the force applied as indicated by arrow 22 further pushes the liquid down the channels 44 and into the biological barrier.
[0154] Referring now to FIG. 5 a further embodiment of the invention is presented. In this embodiment, the projections 14, 16 have cavities therein and are provided such that the cavities are in fluid communication with each other via the head 12. A formation 36 may be provided as described with respect to FIG. 3 to focus pressure and to reduce lateral motion of the micropenetrator within the flexible substrate 3. Within the cavities 46 are injectates 48. These injectates may be solid or liquid or any other formulation. FIG. 5b shows the device in actuation on a biological barrier such that under the effect of force 22 the projections 14, 16 are driven into the biological barrier. Once there, the injectates dissolve and leave the cavities 46 becoming semi-dissolved particles 50. FIG. 6 presents a similar embodiment however provided is an additional opening 52 providing access to the cavities. The cavity is beneficially open at more than one point to allow a flow of material therethrough. In FIG. 6a hollow tubes for the projections and head are presented and disposed therein are injectates 48. Presented in this embodiment, whilst also applicable to any other embodiment, are formations 36 arranged to be deformable. These may be the same or similar configuration to formations 36 as presented with respect to FIG. 3 however in this embodiment the key difference is that they are deformable. Within them there may be a cavity. Accordingly, injectates 48 may be forced from the cavity 46 to enter the biological barrier 5. The formation 36 as shown in FIG. 6b can be seen to have collapsed thus imparting additional force to the micro-penetrator arrangement 10.
[0155] Referring to FIG. 7 and with particular but not exclusive reference to the third aspect of the present invention, a flexible substrate 3 is presented having a first side for contacting the biological barrier and a second side 8. A micro-penetrator arrangement 10 comprises a head 12 and projecting from the head towards the first side 4 is a projection 14. The projection extends from the head to a tip 18 wherein at least a portion of the projection 14 is curved intermediate the head 12 and the tip 18. As shown in the exemplary embodiment the projection is a repeating curved pattern. The curved pattern may be a linear projection twisted to form the final curved configuration. The cross-section of the projection 14 may be non-circular. The provision of a curved portion of the projection aids in transfer of a drug or biological material to the biological barrier 5.
[0156] In order to improve transfer of a drug or biological material through the biological barrier a further supplementary projection may be utilised. A supplementary projection may be wrapped around the projection 14 and/or may be intertwined with the projection. A supplementary projection may extend from the head.
[0157] Referring to FIGS. 8a and 8b, a further embodiment is presented whereby the at least one projection 14 is at least partially curved. In this embodiment, a first and second micro-penetrator 10 may be provided whereby the respective projections are each intertwined.
[0158] Referring now to FIG. 9, another alternative embodiment according to aspects of the present invention is presented. Again an exemplary embodiment has been shown utilising supplementary layer 6 with the head 12 embedded therein. It is reiterated that supplementary layer 6 is not essential neither is the precise configuration of the micro-penetrator arrangement 10. In this embodiment, however, there are undulations 60 provided in the first side of the flexible substrate 3. The biological barrier contact surface is therefore sculpted and is beneficial in delivering liquids or solids applied to the contact surface of the device. This is particularly beneficial, for the purpose of getting an immune response, like an allergy diagnosis patch, or vaccine patch. The undulations and thus recesses formed are beneficially provided in the flexible substrate 3 and the one or more projections 14, 16 extend through the recess 60.
[0159] Referring to FIG. 10, there is a plan view of an exemplary embodiment of the present invention. In this plan view flexible substrate 3 is shown and layered in parallel with the flexible substrate 3 which effectively forms a first layer is a second layer 70. The second layer 70 is layered on top of the first layer. The layer 70 carries a plurality of projections projecting into the page as presented in FIG. 10. A variety of configurations of projection may be utilised including one or more projections having the form as described in any of the embodiments described herein. The projections may be integrally formed with the first layer 70 or as shown in FIG. 10 the head 12 is visible. As such the projections extending from the head 12 project through the first layer and through the second layer and subsequently into the biological barrier. A plurality of first zones 72 are provided from which a projection extends separated by a plurality of second zones 74. The second zones 74 also beneficially comprise a plurality of apertures 74a therein. It is beneficial that the first zones have a greater stiffness than the second zones as this ensures the projections do not deflect laterally upon insertion into a biological barrier and that as force is applied onto the first layer 70 the second zones can bend and flex such that treatment can be applied to the specific areas of the biological barrier as appropriate dependent upon the position of the applied force.
[0160] In another embodiment, the second zones may be provided configured to break or fracture upon applied force to enable accurate treatment of specific areas of the biological barrier without significantly impacting upon adjacent areas.
[0161] Referring to FIG. 11 in which presented a further embodiment of the present invention. In this embodiment the device is configured particularly for accommodating the anatomical profile of a fingertip. Accordingly, the second side 8 of the substrate 3 is beneficially concave. It is beneficial that the substrate material 3 is silicone rubber as such a material is readily conformable to the geometry of a fingertip. The opposing first side 4 is beneficially convex and in use a finger can be rolled across the skin to contact the projections 14, 16 with the skin to cause penetration. It is beneficial that the leading edge 8 is curved reflecting the leading edge of a fingertip whereas the trailing edge can be generally linear or curved depending upon particular requirements.
[0162] In any embodiment, the one or more projections of a micropenetrator arrangement may have notches, pockets, holes, serrations or undulations therein. Furthermore, they may be coated with other substances, such as another metal. In another embodiment, a projection may have a coating that terminates before reaching the distal end of the projection, such that the projection extends from the coating material. A coating may be provided for example to increase lubricity.
[0163] In any embodiment it will be appreciated that projections may be positioned sufficiently close to one another so that a material to be administered into the biological barrier may be carried and supported in the separation between the projections. The material may be a variety of materials as described elsewhere in the specification including for example a drug.
[0164] Aspects of the present invention have been described by example only and it will be appreciated to the skilled addressee that modifications and variations may be made without departing from the scope of protection afforded by the appended claims.
