WO1997048441A1 - Device for enhancing transdermal sampling - Google Patents
Device for enhancing transdermal sampling Download PDFInfo
- Publication number
- WO1997048441A1 WO1997048441A1 PCT/US1997/010595 US9710595W WO9748441A1 WO 1997048441 A1 WO1997048441 A1 WO 1997048441A1 US 9710595 W US9710595 W US 9710595W WO 9748441 A1 WO9748441 A1 WO 9748441A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- agent
- sampling
- microblades
- skin
- body surface
- Prior art date
Links
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- 239000005977 Ethylene Substances 0.000 description 1
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Classifications
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- 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
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- 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
- A61B5/14507—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 specially adapted for measuring characteristics of body fluids other than blood
- A61B5/1451—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 specially adapted for measuring characteristics of body fluids other than blood for interstitial fluid
- A61B5/14514—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 specially adapted for measuring characteristics of body fluids other than blood for interstitial fluid using means for aiding extraction of interstitial fluid, e.g. microneedles or suction
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- A61B5/150007—Details
- A61B5/150053—Details for enhanced collection of blood or interstitial fluid at the sample site, e.g. by applying compression, heat, vibration, ultrasound, suction or vacuum to tissue; for reduction of pain or discomfort; Skin piercing elements, e.g. blades, needles, lancets or canulas, with adjustable piercing speed
- A61B5/150061—Means for enhancing collection
- A61B5/150099—Means for enhancing collection by negative pressure, other than vacuum extraction into a syringe by pulling on the piston rod or into pre-evacuated tubes
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- A61B5/150007—Details
- A61B5/150206—Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
- A61B5/150274—Manufacture or production processes or steps for blood sampling devices
- A61B5/150282—Manufacture or production processes or steps for blood sampling devices for piercing elements, e.g. blade, lancet, canula, needle
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- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
- A61B5/150381—Design of piercing elements
- A61B5/150412—Pointed piercing elements, e.g. needles, lancets for piercing the skin
- A61B5/150427—Specific tip design, e.g. for improved penetration characteristics
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- A61B5/150969—Low-profile devices which resemble patches or plasters, e.g. also allowing collection of blood samples for testing
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- A61B5/150977—Arrays of piercing elements for simultaneous piercing
- A61B5/150984—Microneedles or microblades
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- A61B5/15101—Details
- A61B5/15103—Piercing procedure
- A61B5/15105—Purely manual piercing, i.e. the user pierces the skin without the assistance of any driving means or driving devices
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- A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
- A61B5/15101—Details
- A61B5/15103—Piercing procedure
- A61B5/15107—Piercing being assisted by a triggering mechanism
- A61B5/15113—Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button
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- A—HUMAN NECESSITIES
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- A61B5/15142—Devices intended for single use, i.e. disposable
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- A—HUMAN NECESSITIES
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- A61N1/18—Applying electric currents by contact electrodes
- A61N1/20—Applying electric currents by contact electrodes continuous direct currents
- A61N1/30—Apparatus for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body, or cataphoresis
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- A61N1/18—Applying electric currents by contact electrodes
- A61N1/20—Applying electric currents by contact electrodes continuous direct currents
- A61N1/30—Apparatus for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body, or cataphoresis
- A61N1/303—Constructional details
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- 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
- A61B10/0045—Devices for taking samples of body liquids
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- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
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- A61B17/205—Vaccinating by means of needles or other puncturing devices
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- A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
- A61M2037/0007—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin having means for enhancing the permeation of substances through the epidermis, e.g. using suction or depression, electric or magnetic fields, sound waves or chemical agents
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- A—HUMAN NECESSITIES
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- 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
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- A—HUMAN NECESSITIES
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- 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
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- 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
- A61M2037/0046—Solid microneedles
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- 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
- A61M2037/0053—Methods for producing microneedles
Definitions
- the mechanism may involve an increase in the permeability ⁇ of the body surface or in the case of electrotransport sampling a reduction of 9 the electrical resistance of the body surface to the passage of the agent
- pad 106 4 and osmotic membrane 94 are combined in one layer of absorbent hydrogel 5 that stores the absorbed fluid as well as the agent.
- the pad 106 is 6 free to expand or is encapsulated in the semi-permeable or osmotic membrane 7 94 so that it retains the fluid therein.
- ⁇ Member 2 is used in conjunction with the percutaneous sampling of an 9 agent.
- sampling is used broadly herein to include withdrawal of or
- the opening 8 corresponds to the portion of the sheet 6 occupied by each of the microblades prior to the blades being transpositioned into the downward depending position.
- the sheet 6 is formed with an opening 8 between the microblades 4.
- the opening 8 corresponds to the portion of the sheet 6 occupied by each of the microblades 4 prior to the microblades being bent into a position which is substantially perpendicular to the plane of sheet 6.
- the number of openings 8 per device and the number of microblades 4 per device are independent.
- the device may have only one large opening 8 with a plurality of microblades 4 around the opening.
- metals and metal alloys include but are not limited to stainless steel, iron, steel, tin, zinc, copper, platinum, aluminum, germanium, nickel, zirconium, titanium and titanium alloys consisting of nickel, molybdenum and chromium, metals plated with nickel, gold, rhodium, iridium, titanium, platinum, and the like.
- An example of glasses include a devitrified glass such as "PHOTOCERAM” available from Corning in Corning, NY.
- the present invention has a blade density of at least about 10 blades/cm 2 and less than about 1000 blades/cm 2 , preferably at least about 600 blades/cm 2 , more preferably at least about 800 blades/cm 2 .
- the number of openings per unit area through which the agent passes is at least about 10 openings/cm 2 and less than about 1000 openings/cm 2 .
- the present invention produces a percolation area of about 0.005 to .05 cm 2 /cm 2 of body surface, preferably about 0.01 cm 2 /cm 2 of body surface.
- passive transdermal sampling devices are used with member 2. Two examples of passive transdermal sampling devices are illustrated in Figures 4 and 5.
- passive transdermal sampling device 88 comprises a reservoir 90 sandwiched between a backing layer 92, which is preferably impermeable to the agent, and a wicking membrane 94.
- the reservoir 90 is formed of a material, such as a rubbery polymer, that is sufficiently viscous to maintain its shape.
Abstract
Description
Claims
Priority Applications (7)
Application Number | Priority Date | Filing Date | Title |
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DE69730973T DE69730973T2 (en) | 1996-06-18 | 1997-06-18 | DEVICE FOR IMPROVING THE TRANSDERMAL ACCEPTANCE OF BODY FLUIDS |
EP97932206A EP0917484B1 (en) | 1996-06-18 | 1997-06-18 | Device for enhancing transdermal sampling |
DK97932206T DK0917484T3 (en) | 1996-06-18 | 1997-06-18 | Device for enhancing transdermal sampling |
AT97932206T ATE277671T1 (en) | 1996-06-18 | 1997-06-18 | DEVICE FOR IMPROVING TRANSDERMAL DELIVERY OF BODY FLUID |
CA002253471A CA2253471C (en) | 1996-06-18 | 1997-06-18 | Device for enhancing transdermal sampling |
JP50331298A JP3847790B2 (en) | 1996-06-18 | 1997-06-18 | Device for enhancing transdermal sampling |
AU35725/97A AU3572597A (en) | 1996-06-18 | 1997-06-18 | Device for enhancing transdermal sampling |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
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US1999096P | 1996-06-18 | 1996-06-18 | |
US60/019,990 | 1996-06-18 |
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WO1997048441A1 true WO1997048441A1 (en) | 1997-12-24 |
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Application Number | Title | Priority Date | Filing Date |
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PCT/US1997/010516 WO1997048440A1 (en) | 1996-06-18 | 1997-06-17 | Device for enhancing transdermal agent delivery or sampling |
PCT/US1997/010595 WO1997048441A1 (en) | 1996-06-18 | 1997-06-18 | Device for enhancing transdermal sampling |
PCT/US1997/010596 WO1997048442A1 (en) | 1996-06-18 | 1997-06-18 | Device for enhancing transdermal agent delivery or sampling |
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PCT/US1997/010516 WO1997048440A1 (en) | 1996-06-18 | 1997-06-17 | Device for enhancing transdermal agent delivery or sampling |
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PCT/US1997/010596 WO1997048442A1 (en) | 1996-06-18 | 1997-06-18 | Device for enhancing transdermal agent delivery or sampling |
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US (5) | US6230051B1 (en) |
EP (3) | EP0914178B1 (en) |
JP (4) | JP4012252B2 (en) |
AR (2) | AR008242A1 (en) |
AT (3) | ATE234129T1 (en) |
AU (3) | AU3399197A (en) |
CA (3) | CA2253549C (en) |
DE (3) | DE69719761T2 (en) |
DK (3) | DK0914178T3 (en) |
ES (3) | ES2195151T3 (en) |
PT (2) | PT917483E (en) |
TW (1) | TW349872B (en) |
WO (3) | WO1997048440A1 (en) |
ZA (1) | ZA975326B (en) |
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