WO2007002521A2 - Microneedle array applicator device - Google Patents

Microneedle array applicator device Download PDF

Info

Publication number
WO2007002521A2
WO2007002521A2 PCT/US2006/024671 US2006024671W WO2007002521A2 WO 2007002521 A2 WO2007002521 A2 WO 2007002521A2 US 2006024671 W US2006024671 W US 2006024671W WO 2007002521 A2 WO2007002521 A2 WO 2007002521A2
Authority
WO
WIPO (PCT)
Prior art keywords
microneedle array
application device
impactor
housing
patch
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/US2006/024671
Other languages
English (en)
French (fr)
Other versions
WO2007002521A3 (en
Inventor
Franklyn L. Frederickson
Michael D. Johnson
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
3M Innovative Properties Co
Original Assignee
3M Innovative Properties Co
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 3M Innovative Properties Co filed Critical 3M Innovative Properties Co
Priority to CN2006800233630A priority Critical patent/CN101208130B/zh
Priority to JP2008519435A priority patent/JP5144510B2/ja
Priority to AU2006261898A priority patent/AU2006261898B2/en
Priority to CA2613111A priority patent/CA2613111C/en
Priority to EP06773934A priority patent/EP1901799B1/en
Priority to US11/993,137 priority patent/US8784363B2/en
Publication of WO2007002521A2 publication Critical patent/WO2007002521A2/en
Publication of WO2007002521A3 publication Critical patent/WO2007002521A3/en
Anticipated expiration legal-status Critical
Priority to US14/333,676 priority patent/US9789249B2/en
Ceased legal-status Critical Current

Links

Classifications

    • 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/158—Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/20—Surgical instruments, devices or methods for vaccinating or cleaning the skin previous to the vaccination
    • A61B17/205—Vaccinating by means of needles or other puncturing devices
    • 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
    • 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/158—Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
    • A61M2005/1585—Needle inserters
    • 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
    • A61M2037/0023—Drug applicators using microneedles

Definitions

  • a microneedle array application device in a first aspect of the present invention, includes a housing and an impactor.
  • the housing has a skin-contacting face that defines an opening that can be positioned at a target site.
  • the impactor is capable of impacting a microneedle array and accelerating the microneedle array toward the target site.
  • the impactor is further capable of moving along an arcuate path to move the microneedle array toward the target site.
  • a microneedle array application device in another aspect of the present invention, includes a housing and an impactor.
  • the housing has a skin-contacting face that defines an opening that can be positioned at a target site.
  • the impactor is capable of impacting a microneedle array and accelerating the microneedle array toward the target site.
  • the impactor comprises a magnet suitable for releasably retaining a magnetic microneedle patch.
  • a method of microneedle array application includes providing a microneedle application device capable of accelerating a microneedle array toward a target site, mounting the microneedle array on the microneedle array application device, and moving the microneedle array toward the target site along a substantially arcuate path.
  • FIG. 6F is a cross-sectional view of the applicator of FIGS. 6 A, B being removed from a microneedle array that has been deployed onto a target surface.
  • FIG. 7A is perspective top view of still another applicator device.
  • FIG. 7D is a cross-sectional view of the applicator of FIGS. 7A 5 B in a position where a microneedle array can contact a target surface.
  • a non-stick or release surface can be achieved, for example, by a non-stick or release coating applied to the upper surfaces 42.
  • the non-stick or release coating can be selected according to the desired use of the applicator device 20.
  • a release coating such as a low surface energy silicone, fluoropolymer, or fluoro-silicone release coating, can be selected based upon the adhesives used with patches applied using the patch application device 20.
  • a blade or other cutting means can be provided as part of the mounting structure, for separating portions of items from patches mounted on the applicator.
  • the upper cover structure 26 is connected to the base 24 at or near a perimeter of the base 24.
  • Energy stored in the torsion spring 68 can be used to accelerate the impactor 62 toward a patch and also to accelerate a patch that has contacted the impactor 62.
  • the amount of energy stored in the torsion spring 68 will vary depending on the amount of displacement of the impactor 62 away from the opening 32 and along the arcuate path.
  • the appropriate torsion spring constant will depend upon a number of parameters, including the mass of the patch acceleration assembly, the mass of the patch, the arc length through which the patch acceleration assembly travels, and the desired speed of the patch on impact with a surface.
  • the torsion spring constant will often be more than about 0.5 Newton*rnm/degree and sometimes more than about 2.0 Newton*mm/degree.
  • the design of the mounting structure is generally independent of the design of other components of the applicator device 20.
  • one or more patches can be stored inside the housing 22 prior to application, and then dispensed for application to a target site.
  • the microneedle array 74 of the patch 72 can be deployed as follows. An operator "loads” or “energizes” the patch accelerating assembly 38 using the handle 64, to store potential energy in the torsion spring 68, by moving the impactor 62 and frame 60 along the arcuate path. The operator can "load” the patch accelerating assembly 38 either before or after the patch 72 is mounted to the device 20.
  • the applicator device 20 is also positioned against an application surface, and the opening 32 is positioned relative to a target site for patch delivery. Suitable sites for microneedle patch application on a patient's skin will vary, and the operator must select a suitable position and orientation of the applicator device 20.
  • the patch accelerating assembly 38 When the patch accelerating assembly 38 is energized, the patch 72 is fully mounted to the applicator device 20, and the device 20 is positioned relative to the target location, the operator then actuates the impactor 62 by releasing the energy stored in the torsion spring 68, which moves the impactor 62 toward the patch 72 along an arcuate path, which can correspond to the arcuate path defined by the slot 48 in the housing 22.
  • the patch may be directly affixed or otherwise releasably held by the patch acceleration assembly.
  • the patch may be releasably held to the impactor through magnetic attraction.
  • the impactor may comprise a magnet and the patch may comprise a metal capable of magnetic attraction.
  • the impactor for example, may be a permanent magnet or an electromagnet and the patch backing may comprise a metal that can be magnetically attracted.
  • a thin layer of ferrous foil may be incorporated into the patch backing. Such a magnetic attraction can allow the patch to be held to the impactor until the patch contacts the skin.
  • FIG. 120 having a housing 122 that includes a base 124 and an upper cover structure 126.
  • the device is elongate in shape and has a first, tapered end 127 and a second end 129.
  • the second end 129 has a top and bottom sealed by a top peelable seal 131 having a tab 133 and a bottom peelable seal 132 having a tab 135 (only tab 135 is visible in FIG. 6A).
  • FIG. 6B shows the applicator device after the peelable seals 131, 132 have been removed.
  • a trigger 137 is integrally formed in the top surface of the housing 122.
  • the trigger is connected to the top surface of the housing at a single attachment point 139, thus allowing the trigger to be deflected downward by thumb or finger pressure as shown in FIG. 6D.
  • FIG. 7A is a perspective top view of another embodiment of an applicator device 220 having a housing 222 that includes a base 224 and an upper cover structure 226. A trigger 237 extends from the upper cover structure 226.
  • FIG. 7A is a perspective top view of another embodiment of an applicator device 220 having a housing 222 that includes a base 224 and an upper cover structure 226. A trigger 237 extends from the upper cover structure 226.
  • FIG. 7D shows a lowered position, such as shown in FIG. 7D.
  • the trigger 237 may be pushed sideways, as shown in FIG. 7D, thus releasing the movable end 269 of the drive member 266 and allowing the drive member 266 to bias the impactor 270 towards the patch 272 and the skin-contacting face 224.
  • the impactor 270 drives the patch 272 from the retainers 240 and past the skin-contacting face 224 so that the patch is pressed against the skin surface (not shown).
  • FIG. 7E shows the device 220 being removed from the skin surface 281, leaving a patch 272 with a microneedle array 274 in place on the skin surface 281.
  • the microneedles will penetrate to a depth of more than 40 ⁇ m, sometimes more than 80 ⁇ m, and occasionally more than 100 ⁇ m. In one embodiment, the microneedles will penetrate to a depth of less than 300 ⁇ m, sometimes less than 200 ⁇ m, and occasionally less than 150 ⁇ m. In another embodiment, the microneedles will penetrate to a depth that is more than 20% of the full height of the microneedle, sometimes more than 40%, and occasionally more than 50%. In another embodiment, the microneedles will penetrate to a depth that is less than about 80% of the full height of the microneedle, sometimes less than 60%, and occasionally less than 50%.
  • the application device be designed such that the microneedle array travels at a velocity at or above the desired minimum velocities over a distance that is sufficient to accommodate the variations in skin location and appendage size relative to the application device.
  • the microneedle array in the application device may move at or above the minimum velocity over a distance of one millimeter or more. In some embodiments, the microneedle array may move at or above the minimum velocity over a distance of 5 millimeters or more.
  • microneedle arrays useful in the various embodiments of the invention may comprise any of a variety of configurations, such as those described in the following patents and patent applications, the disclosures of which are herein incorporated by reference.
  • One embodiment for the microneedle arrays comprises the structures disclosed in United States Patent Application Publication No. 2003/0045837.
  • the disclosed microstructures in the aforementioned patent application are in the form of microneedles having tapered structures that include at least one channel formed in the outside surface of each microneedle.
  • the microneedles may have bases that are elongated in one direction.
  • the channels in microneedles with elongated bases may extend from one of the ends of the elongated bases towards the tips of the microneedles.
  • Microneedle arrays and microneedle patches of the present invention may be used to deliver drugs (including any pharmacological agent or agents) through the skin in a variation on transdermal delivery, or to the skin for intradermal or topical treatment, such as vaccination.
  • drugs including any pharmacological agent or agents
  • drugs that are of a large molecular weight may be delivered transdermally .
  • Increasing molecular weight of a drug typically causes a decrease in unassisted transdermal delivery.
  • Microneedle arrays of the present invention have utility for the delivery of large molecules that are ordinarily difficult to deliver by passive transdermal delivery. Examples of such large molecules include proteins, peptides, nucleotide sequences, monoclonal antibodies, DNA vaccines, polysaccharides, such as heparin, and antibiotics, such as ceftriaxone.

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medical Informatics (AREA)
  • Surgery (AREA)
  • Anesthesiology (AREA)
  • Hematology (AREA)
  • Dermatology (AREA)
  • Molecular Biology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Vascular Medicine (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
PCT/US2006/024671 2005-06-27 2006-06-23 Microneedle array applicator device Ceased WO2007002521A2 (en)

Priority Applications (7)

Application Number Priority Date Filing Date Title
CN2006800233630A CN101208130B (zh) 2005-06-27 2006-06-23 微针阵列施放器装置
JP2008519435A JP5144510B2 (ja) 2005-06-27 2006-06-23 マイクロニードルアレイ適用装置
AU2006261898A AU2006261898B2 (en) 2005-06-27 2006-06-23 Microneedle array applicator device
CA2613111A CA2613111C (en) 2005-06-27 2006-06-23 Microneedle array applicator device and method of array application
EP06773934A EP1901799B1 (en) 2005-06-27 2006-06-23 Microneedle array applicator device
US11/993,137 US8784363B2 (en) 2005-06-27 2006-06-23 Microneedle array applicator device and method of array application
US14/333,676 US9789249B2 (en) 2005-06-27 2014-07-17 Microneedle array applicator device and method of array application

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US69444705P 2005-06-27 2005-06-27
US60/694,447 2005-06-27
US74629806P 2006-05-03 2006-05-03
US60/746,298 2006-05-03

Related Child Applications (2)

Application Number Title Priority Date Filing Date
US11/993,137 A-371-Of-International US8784363B2 (en) 2005-06-27 2006-06-23 Microneedle array applicator device and method of array application
US14/333,676 Division US9789249B2 (en) 2005-06-27 2014-07-17 Microneedle array applicator device and method of array application

Publications (2)

Publication Number Publication Date
WO2007002521A2 true WO2007002521A2 (en) 2007-01-04
WO2007002521A3 WO2007002521A3 (en) 2007-06-21

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2006/024671 Ceased WO2007002521A2 (en) 2005-06-27 2006-06-23 Microneedle array applicator device

Country Status (7)

Country Link
US (2) US8784363B2 (enExample)
EP (2) EP1901799B1 (enExample)
JP (1) JP5144510B2 (enExample)
CN (1) CN101208130B (enExample)
AU (1) AU2006261898B2 (enExample)
CA (1) CA2613111C (enExample)
WO (1) WO2007002521A2 (enExample)

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WO2012075375A1 (en) * 2010-12-02 2012-06-07 Lanco Biosciences, Inc. Delivery of parathyroid hormones by microinjection systems
WO2012075339A1 (en) * 2010-12-02 2012-06-07 Lanco Biosciences, Inc. Delivery of heparins by microinjection systems
WO2012075209A1 (en) * 2010-12-02 2012-06-07 Lanco Biosciences, Inc. Delivery of triptans by microinjection systems
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JP5144510B2 (ja) 2013-02-13
EP2474338B1 (en) 2013-07-24
CN101208130B (zh) 2012-05-16
WO2007002521A3 (en) 2007-06-21
EP1901799A2 (en) 2008-03-26
CA2613111A1 (en) 2007-01-04
JP2008543527A (ja) 2008-12-04
US20100222743A1 (en) 2010-09-02
EP1901799B1 (en) 2012-06-13
EP2474338A1 (en) 2012-07-11
AU2006261898A1 (en) 2007-01-04
CA2613111C (en) 2015-05-26
US20140330209A1 (en) 2014-11-06
US8784363B2 (en) 2014-07-22
AU2006261898B2 (en) 2011-11-03
US9789249B2 (en) 2017-10-17
CN101208130A (zh) 2008-06-25

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