GB2586738A - Microneedle platform for sensing and delivery - Google Patents

Microneedle platform for sensing and delivery Download PDF

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Publication number
GB2586738A
GB2586738A GB2015800.2A GB202015800A GB2586738A GB 2586738 A GB2586738 A GB 2586738A GB 202015800 A GB202015800 A GB 202015800A GB 2586738 A GB2586738 A GB 2586738A
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GB
United Kingdom
Prior art keywords
patch according
microneedles
microneedle
patch
sensing
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Granted
Application number
GB2015800.2A
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GB202015800D0 (en
GB2586738B (en
Inventor
Sharma Sanjiv
Guy Owen
E G CASS Anthony
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Swansea University
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Swansea University
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Publication of GB2586738A publication Critical patent/GB2586738A/en
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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
    • A61K9/0009—Galenical forms characterised by the drug release technique; Application systems commanded by energy involving or responsive to electricity, magnetism or acoustic waves; Galenical aspects of sonophoresis, iontophoresis, electroporation or electroosmosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/0035—Vaccination diagnosis other than by injuring the skin, e.g. allergy test patches
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14532—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring glucose, e.g. by tissue impedance measurement
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/1468—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using chemical or electrochemical methods, e.g. by polarographic means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A61B5/685—Microneedles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A61K9/0021—Intradermal administration, e.g. through microneedle arrays, needleless injectors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
    • A61K9/703—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14546—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring analytes not otherwise provided for, e.g. ions, cytochromes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/1468—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using chemical or electrochemical methods, e.g. by polarographic means
    • A61B5/1473—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using chemical or electrochemical methods, e.g. by polarographic means invasive, e.g. introduced into the body by a catheter
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6879—Means for maintaining contact with the body
    • A61B5/688—Means for maintaining contact with the body using adhesives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
    • A61M2037/0038—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles having a channel at the side surface
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
    • A61M2037/0061—Methods for using microneedles

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Physics & Mathematics (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Chemical & Material Sciences (AREA)
  • Pathology (AREA)
  • Dermatology (AREA)
  • Molecular Biology (AREA)
  • Surgery (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Biophysics (AREA)
  • Medicinal Chemistry (AREA)
  • Optics & Photonics (AREA)
  • Anesthesiology (AREA)
  • Hematology (AREA)
  • Emergency Medicine (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)

Abstract

The invention concerns a dual function patch for delivering an agent into an individual and sensing an analyte typically associated with the delivery of, or effect of, said agent; and a method of delivering an agent into the skin and sensing an analyte typically associated with the delivery of, or effect of, said agent using said patch.

Claims (30)

1. A dual function patch for delivering at least one agent to an individual and for sensing an analyte under/in the vicinity of said patch, which analyte is typically associated with the delivery of, or effect of, said agent comprising: - a base; and - a plurality of microneedles attached to, or associated with, said base, wherein at least one of said microneedles is a delivery microneedle provided with an agent delivery feature and either said delivery microneedle and/or at least one alternative microneedle is a sensing microneedle provided with a sensing feature for measuring voltage/current flow or resistance/impedance in situ that is indicative of at least one analyte in situ.
2. The patch according to claim 1 wherein the patch is adapted to be attached to the skin.
3. The patch according to any preceding claim wherein the base and microneedles may be manufactured from the same or different materials .
4. The patch according to any preceding claim wherein said base and/or microneedles are formed of a polymeric substance selected from the group comprising: polymethylmethacrylate (PMMA), polycarbonate, Acrylonitrile- Butadiene-Styrene (ABS), Nylon PA, Polypropylene (PP) and Polystyrene (GPPS).
5. The patch according to any preceding claim wherein the microneedles are solid and are designed to be coated with a swellable or dissolvable or substantially dissolvable material .
6. The patch according to claim 5 wherein the dissolvable or substantially dissolvable material is selected from the group comprising: polyvinyl alcohol (PVA), polyacrylates, polymers of ethylene-vinyl acetates, and other acyl substituted cellulose acetates, polyurethanes, polystyrenes, polyvinyl chloride, polyvinyl fluoride, polyethylene oxide, chlorosulphonate polyolefins, poly(vinyl imidazole), poly(valeric acid), poly butyric acid, poly lactides, 1 polyglycolides, polyanhydrides, polyorthoesters, polysaccharides, gelatin, hydrogels and the like, mixtures, and copolymers thereof.
7. The patch according to any one of claim 5 or 6 wherein said material further comprises at least one agent to be delivered into the skin.
8. The patch according to any one of claims 1-4 wherein the microneedles are hollow and are designed to have at least one aperture so that an agent may be delivered through the aperture into the skin.
9. The patch according to claim 8 wherein hollow microneedles are fashioned to have a plurality of faces or sides such that a part thereof has at least one aperture therein, connected to an agent supply, and is used for agent delivery and another of said faces or sides is solid and used for sensing purposes.
10. The patch according to any preceding claim wherein said base may further comprise at least one channel connected to an agent supply, which supply is positioned adjacent to at least one microneedle, whereby once the microneedles have penetrated the skin, fluid agent flows through said channel(s) along the sides of the microneedles and so into the penetrated skin.
11. The patch according to claim 10 comprising a plurality of channels connected to a pump for actively pumping a supply of agent through the channels.
12. The patch according to any one of claims 10 or 1 1 wherein said channel(s) has an aperture diameter between about 0.20 to about 0.75 mm.
13. The patch according to any one of claims 9-12 wherein said microneedles are pyramidal or conical.
14. The patch according to any preceding claim wherein the microneedles have a length of from about 500 pm to about 900 pm. 2
15. The patch according to any preceding claim wherein said plurality of microneedles are provided or distributed in groups or arrays wherein different groups or arrays have different functions.
16. The patch according to claim 15 wherein at least one group or array is adapted to function as a drug delivery unit and at least one other group or array is adapted to function as a sensor unit.
17. The patch according to any one of claims 15 or 16 wherein at least one group or array comprises microneedles with dual functionality.
18. The patch according to any preceding claim, wherein said microneedle comprises an external conductive layer so that it can function as a sensing microneedle.
19. The patch according to claims 16-18 wherein a plurality of said microneedles are positioned together or adjacent each other to act as a single unit or electrode, wherein the outer conducting layer of the group of electrodes acts as the working electrode of an electrochemical (bio)sensor.
20. The patch according to any one of claims 1-19 wherein the sensing microneedle(s) or sensing unit, comprise an electrical connection by which the microneedle(s) or sensing unit receive(s) an electrical signal and, further, a processor is provided to process sensing signal(s) from said microneedle(s) or sensing unit and to generate a sensor output signal.
21. The patch according to any one of the preceding claims wherein at least one of the microneedles is adapted to be a reference electrode and/or at least one of the microneedles is adapted to be a counter electrode.
22. The patch according to any one of the preceding clams wherein at least one sensing microneedle or sensing unit is functionalized or adapted to detect the presence of a particular analyte and is adapted to produce a voltage signal indicative of the presence of said analyte. 3
23. The patch according to claim 22 wherein the microneedle(s) are functionalized to allow multi-analyte sensing.
24. The patch according to any one of claims 20-23 wherein said processor is arranged to generate a sensor output signal that is an average of the signals from at least two electrodes.
25. The patch according to any one of claims 22-24 wherein at least three microneedles or groups/arrays of microneedles are functionalized in the same way.
26. The patch according to claim 25 wherein said processor is adapted to identify a signal from at least two of the at least three electrodes.
27. The patch according to any preceding claim wherein at least one of the microneedles or microneedle groups/arrays is adapted to release a known quantity/concentration of analyte which is then used for the internal calibration of the sensor output.
28. The patch according to any preceding claim wherein the patch comprises several groups/arrays or subgroups/subarrays integrated on the same patch to enable the delivery of a number of agents and also the sensing of analytes in the vicinity of the patch in response to the delivery of the different agents.
29. A method for delivering at least one agent to an individual and for sensing an analyte associated with the delivery of, or effect of, said agent comprising: providing a dual function patch comprising a base to which there is attached, or associated with, at least one microneedle adapted for the delivery of an agent and either said delivery microneedle and/or at least one alternative microneedle is adapted for sensing voltage/current flow or resistance/impedance in situ which voltage/current flow or resistance/impedance is indicative of at least one analyte in sit , attaching said patch to the skin of an individual whereby said agent is delivered into said skin; 4 sensing, continuously or periodically, voltage/current flow or resistance/ impedance via said sensing microneedle(s); and processing said voltage/current flow or resistance/ impedance to determine the amount of said analyte whereby the amount of voltage/current or changes in resistance/ impedance, respectively, is indicative of the amount of a selected analyte.
30. The method according to claim 29 wherein the method further includes the step of providing said patch with at least one calibration microneedle adapted for the delivery of a known amount of a selected analyte whereby the delivery of said known amount of said selected analyte generates a voltage/current that can be used to calibrate the patch. 5
GB2015800.2A 2018-03-27 2019-03-26 Microneedle platform for sensing and delivery Active GB2586738B (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GBGB1804880.1A GB201804880D0 (en) 2018-03-27 2018-03-27 Microneedle platform for sensing and delivery
PCT/GB2019/050846 WO2019186129A1 (en) 2018-03-27 2019-03-26 Microneedle platform for sensing and delivery

Publications (3)

Publication Number Publication Date
GB202015800D0 GB202015800D0 (en) 2020-11-18
GB2586738A true GB2586738A (en) 2021-03-03
GB2586738B GB2586738B (en) 2022-10-05

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GBGB1804880.1A Ceased GB201804880D0 (en) 2018-03-27 2018-03-27 Microneedle platform for sensing and delivery
GB2015800.2A Active GB2586738B (en) 2018-03-27 2019-03-26 Microneedle platform for sensing and delivery

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GBGB1804880.1A Ceased GB201804880D0 (en) 2018-03-27 2018-03-27 Microneedle platform for sensing and delivery

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WO (1) WO2019186129A1 (en)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA3114763A1 (en) * 2018-10-02 2020-04-09 WearOptimo Pty Ltd System for performing measurements on a biological subject
US20230023786A1 (en) 2019-12-11 2023-01-26 Gaston Adrian Crespo Paravano Methods of modifying microneedles and needles for transdermal electrochemical detection of ions and (bio)molecules
CN111349551B (en) * 2020-03-06 2023-05-09 华中科技大学同济医学院附属协和医院 Microneedle patch capable of extracting microorganisms in skin tissue fluid and preparation method thereof
GB202017333D0 (en) * 2020-10-02 2020-12-16 Continuous Diagnostics Ltd Continuous sensor
CN116531610B (en) * 2023-06-27 2023-12-29 北京大学 Closed loop system of diabetes sensor and manufacturing method thereof

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1996014026A1 (en) * 1994-11-04 1996-05-17 Elan Medical Technologies Limited Analyte-controlled liquid delivery device and analyte monitor
EP1187653B1 (en) * 1999-06-04 2010-03-31 Georgia Tech Research Corporation Devices for enhanced microneedle penetration of biological barriers
WO2013058879A2 (en) * 2011-09-02 2013-04-25 The Regents Of The University Of California Microneedle arrays for biosensing and drug delivery
EP1590034B1 (en) * 2002-10-07 2014-05-14 Biovalve Technologies, Inc. Microneedle array patch

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1996014026A1 (en) * 1994-11-04 1996-05-17 Elan Medical Technologies Limited Analyte-controlled liquid delivery device and analyte monitor
EP1187653B1 (en) * 1999-06-04 2010-03-31 Georgia Tech Research Corporation Devices for enhanced microneedle penetration of biological barriers
EP1590034B1 (en) * 2002-10-07 2014-05-14 Biovalve Technologies, Inc. Microneedle array patch
WO2013058879A2 (en) * 2011-09-02 2013-04-25 The Regents Of The University Of California Microneedle arrays for biosensing and drug delivery

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GB202015800D0 (en) 2020-11-18
GB201804880D0 (en) 2018-05-09
WO2019186129A1 (en) 2019-10-03
GB2586738B (en) 2022-10-05

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