EP1140275A1 - Ensembles d'injection pourvus d'elements de micro-perforation, utilises avec des dispositifs medicaux, et leurs procedes d'utilisation - Google Patents

Ensembles d'injection pourvus d'elements de micro-perforation, utilises avec des dispositifs medicaux, et leurs procedes d'utilisation

Info

Publication number
EP1140275A1
EP1140275A1 EP99966326A EP99966326A EP1140275A1 EP 1140275 A1 EP1140275 A1 EP 1140275A1 EP 99966326 A EP99966326 A EP 99966326A EP 99966326 A EP99966326 A EP 99966326A EP 1140275 A1 EP1140275 A1 EP 1140275A1
Authority
EP
European Patent Office
Prior art keywords
insertion set
micro
tissue
substrate
analyte
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.)
Withdrawn
Application number
EP99966326A
Other languages
German (de)
English (en)
Inventor
Susan M. Mcconnell
Peter C. Lord
John H. Livingston
Paul H. Kovelman
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.)
Medtronic Minimed Inc
Original Assignee
Minimed Inc
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 Minimed Inc filed Critical Minimed Inc
Publication of EP1140275A1 publication Critical patent/EP1140275A1/fr
Withdrawn legal-status Critical Current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
    • 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
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/20—Surgical instruments, devices or methods, e.g. tourniquets 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
    • A61M2037/0023—Drug applicators 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
    • 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
    • A61M2037/003—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 lumen

Definitions

  • This invention relates to insertion sets for use with medical devices and, in particular embodiments, to insertion sets that use micro-piercing members for use with infusion pumps, test apparatuses, drug delivery systems and/or sensors.
  • medications have been delivered by injection with a single, fine gauge needle or through an intravenous infusion set with a catheter.
  • the administration of an injection with a needle or an intravenous infusion through a catheter is often accompanied by a small amount of pain or discomfort as the needle or catheter is inserted and withdrawn from the injection or infusion site. This often acts as a deterrent to compliance with a medical regimen as patients seek to avoid the pain or discomfort.
  • finer needles or catheters have been used. However, the finer needles and catheters still irritate the skin and associated nerve endings, causing some discomfort and pain, and deterring patient compliance.
  • drug delivery systems have been developed that deliver the medication by infusion into subcutaneous tissue using an infusion set with a soft cannula.
  • the soft cannula of the infusion set is still inserted into the skin with a needle to prevent kinking of the soft cannula.
  • This while less traumatic than some other injections, still causes some, although small, discomfort and irritation from the insertion and removal of the needle.
  • One attempt to greatly reduce discomfort and pain has involved the use of automatic insertion devices. But there is still the possibility of some minor irritation since the needle and soft cannula can contact nerves in the subcutaneous tissue.
  • silicon micro- needles have been proposed that would pierce the skin to a very minor depth at a distance that does not contact nerve cells and avoids any introduction of pain.
  • this experimental technique is promising there has been no practical application proposed to deliver the medication through these solid micro-needles.
  • One example of typical silicon micro-needles is shown in Fig. 1, and described in "Break Throughs - Technology - Microneedles", Discover magazine, October 1998 (pages 22 and 23), and "Microfabricated Microneedles: A Novel Approach to Transdermal Drug Delivery", Journal of Pharmaceutical Sciences, Volume 87, Number 8, August 1998 (Pages 922-925), which are attached hereto as part of this specification and incorporated by reference.
  • bodily characteristics are determined by obtaining a sample of bodily fluid. For example, diabetics often test for blood glucose levels. Traditional blood glucose determinations have utilized a painful finger prick using a lancet to withdraw a small blood sample. This results in discomfort from the lancet as it contacts nerves in the subcutaneous tissue. The pain of lancing and the cumulative discomfort from multiple needle pricks is a strong reason why patients fail to comply with a medical testing regimen. Although non-invasive systems have been proposed, or are in development, none to date have been commercialized, which are effective and provide accurate results.
  • an insertion set for essentially painless insertion through tissue of a patient includes a substrate, a plurality of micro-piercing members and a control structure.
  • the plurality of micro-piercing members are coupled to the substrate to form a patch.
  • the micro-piercing members have a predetermined length to pierce the tissue to a predetermined depth to interact with the tissue of the patient.
  • the control structure is within the insertion set for directing and controlling the flow of fluid relative to the substrate and the plurality of micro-piercing members of the insertion set.
  • the insertion set may include or utilize methods or structures for maintaining the insertion set on the tissue for a predetermined period of time.
  • the predetermined length of the at least one micro- piercing member is long enough to pierce the tissue, and yet short enough to avoid contacting the nerves in the tissue.
  • Still further embodiments of the present invention include a light controlling structure within the insertion set for controlling the entry of light relative to the substrate and the at least one micro- piercing member of the insertion set.
  • Some embodiments include a fluorescent analyte detection compound (or other detection compound) to detect the level of an analyte in the tissue, while other embodiments of the insertion set are an infusion set for infusing a liquid into the tissue.
  • Other embodiments of an insertion set are a combination of an infusion set and a sensor set to perform both functions.
  • an insertion set for essentially painless insertion through tissue of a patient includes a substrate, a plurality of micro-piercing members, and a light controlling structure.
  • the plurality of micro-piercing members are coupled to the substrate to form a patch.
  • the micro-piercing members have a predetermined length to pierce the tissue to a predetermined depth to interact with the tissue of the patient.
  • the light controlling structure is within the insertion set for controlling the entry of light relative to the substrate and the plurality of micro-piercing members of the insertion set.
  • the insertion set may include or utilize methods or structures for maintaining the insertion set on the tissue for a predetermined period of time.
  • the predetermined length of the at least one micro- piercing member is long enough to pierce the tissue, and yet short enough to avoid contacting the nerves in the tissue.
  • Still further embodiments of the present invention include a light controlling structure within the insertion set for controlling the entry of light relative to the substrate and the at least one micro- piercing member of the insertion set.
  • Some embodiments include a fluorescent analyte detection compound (or other detection compound) to detect the level of an analyte in the tissue, while other embodiments of the insertion set are an infusion set for infusing a liquid into the tissue.
  • Other embodiments of an insertion set are a combination of an infusion set and a sensor set to perform both functions.
  • an insertion set for insertion through a material includes a substrate and at least one micro-piercing member.
  • the at least one micro-piercing member is coupled to the substrate to form a patch.
  • the at least one micro-piercing member has a predetermined length to pierce the material to a predetermined depth to interact with the material.
  • the insertion set also includes a control structure within the insertion set for controlling the flow of fluid relative to the substrate and the at least one micro-piercing member of the insertion set.
  • the insertion set may include or utilize methods or structures for maintaining the insertion set on the material for a predetermined period of time.
  • the predetermined length of the at least one micro-piercing member is long enough to pierce the material, and yet short enough to avoid contacting contact sensitive elements in the material.
  • Still further embodiments of the present invention include a light controlling structure within the insertion set for controlling the entry of light relative to the substrate and the at least one micro- piercing member of the insertion set.
  • Some embodiments include a fluorescent analyte detection compound (or other detection compound) to detect the level of an analyte in the material, while other embodiments of the insertion set are an infusion set for infusing a liquid into the material.
  • Other embodiments of an insertion set are a combination of an infusion set and a sensor set to perform both functions.
  • a self-lancing test strip for essentially painless analysis of an analyte in the tissue of a patient includes a substrate, a plurality of micro-piercing members, a control structure, and an analyte strip.
  • the plurality of micro-piercing members are coupled to the substrate to form a patch.
  • the micro-piercing members have a predetermined length to pierce the tissue to a predetermined depth to interact with the tissue of the patient.
  • the control structure is within the insertion set for controlling the flow of fluid relative to the substrate and the plurality of micro- piercing members of the insertion set.
  • the analyte strip is coupled to the substrate to receive fluid from the control structure of the insertion set.
  • the insertion set may include or utilize methods or structures for maintaining the insertion set on the tissue for a predetermined period of time.
  • the predetermined length of the at least one micro-piercing member is long enough to pierce the tissue, and yet short enough to avoid contacting the nerves in the tissue.
  • Some embodiments include a fluorescent analyte detection compound (or other detection compound) to detect the level of an analyte in the tissue.
  • Other embodiments of an insertion set are a combination of an infusion set and a sensor set to perform both functions.
  • Fig. 1 is a perspective view of silicon micro-needles of the type that may be used in embodiments of the present invention.
  • Fig. 2 is a perspective view of an insertion set in accordance with a first embodiment of the present invention.
  • Fig. 3 is a perspective view of an insertion set in accordance with a second embodiment of the present invention.
  • Fig. 4 is a cross-sectional view of the insertion set as shown along the line
  • Fig. 5 is a cross-sectional view of the insertion set shown in Fig. 3 and an encapsulating covering to secure the insertion set to the skin.
  • Fig. 6 is a cross-sectional view of an insertion set in accordance with a third embodiment of the present invention.
  • Fig. 7a is a cross-sectional view of an insertion set in accordance with a fourth embodiment of the present invention.
  • Fig. 7b is an enlarged, partial cross-sectional view of the insertion set as shown in the circle 7b of Fig. 7a.
  • Fig. 8 is a cross-sectional view of an insertion set in accordance with a fifth embodiment of the present invention.
  • Fig. 9 is a cross-sectional view of an insertion set in accordance with a sixth embodiment of the present invention.
  • Fig. 10 is a cross-sectional view of an insertion set in accordance with a seventh embodiment of the present invention.
  • Fig. 11 is a perspective view of a test strip in accordance with an eighth embodiment of the present invention.
  • Fig. 12A is a cross-sectional view of the test strip as shown along line 12- 12 in Fig. 11.
  • Fig. 12B is a cross-sectional view of an alternative embodiment of the test strip shown in Fig. 12A.
  • Figs 13a and 13b are top plan views of an insertion sets in accordance with an embodiment of the present invention that are combinations infusion and sensor sets.
  • Fig. 14 is a cross-sectional view of an insertion set in accordance with another embodiment of the present invention.
  • Fig. 15 is a cross-sectional view of an insertion set in accordance with a further embodiment of the present invention.
  • Fig. 16 is a cross-sectional view of an insertion set in accordance with a still further embodiment of the present invention.
  • Fig. 17 is a partial bottom plan view of a capillary structure for a layer in the insertion set shown in Fig. 16.
  • Fig. 18(a) is a perspective view of an open encapsulating test strip in accordance with an additional embodiment of the present invention.
  • Fig. 18(b) is a perspective view of a closed encapsulating test strip in accordance with the embodiment of Fig. 18(a).
  • Fig. 19 is a cross-sectional view of an insertion set in accordance with yet another embodiment of the present invention.
  • Fig. 20 is a cross-sectional view of an insertion set in accordance with still yet another embodiment of the present invention.
  • Fig. 21 is a perspective view of a flexible insertion set in accordance with a further embodiment of the present invention.
  • the invention is embodied in an insertion set such as an infusion set, sensor set. medical device, combination devices, or the like, with micro-piercing members. Further embodiments of the insertion sets or medical devices may utilize biodegradable implants, capsules, impregnated threads (with medications or the like) with the micro-piercing members. In addition, the insertion sets may be coated with medications, or other agents, that inhibit infection and/or promote healing of the insertion site. Preferred embodiments of the insertion sets are for transcutaneous placement of the insertion set in subcutaneous tissue just below the stratum corneum, but above the level where nerves are present.
  • the insertion set may be inserted to deeper depths in the subcutaneous tissue or into other subdermal tissues where the use of micro- piercing members is advantageous.
  • still further embodiments may be used to place the insertion sets in other types of tissue, such as muscle, lymph, organ tissue or the like, and used in animal tissue.
  • the embodiments may also be used in other applications to sample other fluid flows, such as manufacturing, semiconductor fabrication, chemical synthesis, or the like.
  • Further embodiments of the invention are for infusion fluids other than medications, such as vitamins, hormones, drugs, proteins, peptides, suspensions, emulsions, gels, saline or the like.
  • the insertion sets include at least one micro- piercing member attached to a substrate to pierce the tissue during insertion.
  • the micro-piercing member is a micro-metal needle.
  • the micro-needle may be hollow, solid, grooved, or the like.
  • the micro-piercing member may be made out of other materials, such as ceramic, plastic, etched metals, crystals embedded on a surface, fibers (such as glass or carbon), ceramics, glass, composites, silicon, biodegradable, hydrophilic substances, substances that soften and/or change once in contact with the body and/or bodily fluids, or the like.
  • the insertion sets may include more than one micro-piercing member.
  • a single insertion set may include a micro- piercing member for an infusion portion and another micro-piercing member for a separate sensor portion, or the like.
  • the insertion sets may include a plurality of micro-piercing members on a small patch or substrate, such as a series of hollow (or grooved) micro-needles (such as from silicon, plastics, metal or the like) for infusion of a medication or a series of solid micro-needles for sensor applications (such as from silicon, plastics, metal or the like), which microneedles are used to penetrate the skin.
  • Preferred embodiments of the micro- piercing member have a length on the order of 100 ⁇ m. However, longer lengths such as 200 ⁇ m or shorter lengths such as 50 ⁇ m may be used. Other lengths may also be used, with the selection being dependent on the type of tissue to be penetrated, the depth of nerve tissue, condition of the patient, type of medication, the type of body characteristic to be determined, number of micro-piercing members, the size of the insertion set, or the like. The above features may be combined in various configurations to achieve a set with desired characteristics.
  • the micro-piercing members or needles have a circular cross-section.
  • the micro- piercing members may have other cross-sections, such as square, rectangular, triangular, polygonal, oval, ellipsoid or the like.
  • a substrate and micro-piercing members form a rectangular patch.
  • the substrate and micro-piercing members form different shape patches, such as square, triangular, polygonal, oval ellipsoid, or the like.
  • Advantages to the use of micro-piercing members and a substrate structure include a larger surface area for infusion, fluid collection and/or sensing a characteristic, painless insertion, and extremely low profile. The above features may be combined in various configurations to achieve a set with desired characteristics.
  • the substrate structure forming the patch is sized between 1/8" to 1/16" square.
  • the substrate structure forming the patch is sized smaller or can be considerably larger (upwards of several inches square) with the selection of size being dependent on the type of medication to be infused, the characteristic to be determined, the patient condition, the amount of time the insertion set is to remain in position, and/or the like.
  • an insertion set 140 or 142 includes a rigid or flexible substrate 144 that holds at least one sensor 146 to determine a characteristic and at least one infuser 148 to infuse a liquid.
  • the insertion set 140 and 142 are worn most effective on large surface areas, such as the abdomen, back or the like. If the substrate 144 is flexible, the insertion set could be worn around a wrist, arm, leg or the like. In particular embodiments, the sensor 146 and the infuser are separated by several inches if medication is being infused. However, if a calibration fluid is being infused to calibrate the sensor 146, the infuser 148 may be adjacent, combined with, or relatively close to the sensor 146. In another embodiment, as shown in Fig. 21, a plurality of micro-needle patches 147, that are generally rigid, are placed on a larger contoured and/or flexible patch 149 to provide large surface areas for detection and/or infusion of fluids.
  • the insertion set is maintained in position at the insertion site on the tissue with an adhesive overdressing.
  • an adhesive patch (or under-dressing) is placed on the tissue prior to insertion of the insertion set, or is used in addition to an overdressing.
  • the insertion set has wings (or a flange) surrounding the periphery of the insertion set, which have an adhesive that attaches the insertion set to the tissue. This can be augmented by an overdressing and/or an under- dressing.
  • the substrate surface between the micro- piercing members may have an adhesive that attaches the insertion set to the tissue.
  • the insertion set may also be attached by sutures, staples, clamps, glue, or the like.
  • the micro-piercing members are coated with an anti-microbial substance that tends to inhibit infection occurring around the perforation made in the skin.
  • a healing agent such as Vitamin E, anti- inflammatory agents, such as Dexamethasone, or the like, that promotes healing and/or minimizes scaring after removal of the insertion set with the microneedles.
  • micro-piercing members or needles
  • substrates silicon are used to form the micro-piercing members (or needles) and substrates.
  • the micro-piercing members and substrate structure can be formed in silicon through the use of silicon wafer technology such as photolithography, chemical etching, vapor deposition, DREI, laser drilling, and/or the like.
  • metals, ceramics, plastics, or the like are used to form the micro-piercing members and substrate structure.
  • Such materials include, but are not limited to, specially engineered polymer materials designed for deep photo etching using MEMS (Micro Electro Mechanical Systems) processing techniques, or the like.
  • Methods which can be used for creating the structure in ceramics, metal, or plastic include molding, thermoforming, laser drilling, chemical etching and/or the like.
  • Plastics that can be used for the micro-piercing members and substrate structure include, but are not limited to, PEEK (polyetheretherketone) and LCP (Liquid Crystal Polymer), polycarbonates or the like.
  • PEEK and LCP are particularly strong when formed with thin cross-sections and lend themselves to conventional molding techniques.
  • Plastics may be molded (depending on their flow characteristics) or more viscous plastics could require a combination of molding and laser drilling/chemical etching or thermoforming with laser drilling/chemical etching.
  • LCP is a unique plastic that has both amorphous and crystalline segments that form the plastic.
  • the micro-piercing members and substrate could be formed in such a way that the crystalline segments line up in a particular direction.
  • the amorphous segment may be removed using chemical etching leaving the segments (rods, needles or micro-piercing members) of crystalline material exposed. This could also be done in glass filled plastics.
  • the micro- piercing members and the substrate are formed from the same material, either as an integral unit or separately and later connected. However, in alternative embodiments, the micro-piercing members and the substrate may be formed from different materials.
  • the substrate and micro-piercing members are coated with a material that helps maintain the structural integrity of the insertion set and minimizes breakage, fracture and/or loss of micro-piercing members once the insertion set is inserted or during withdrawal of the insertion set.
  • the insertion set and micro-piercing members could be coated with a thin layer (i.e., a few microns) of parylene, plastic or the like.
  • the micro-piercing members and substrate structure are generally optically opaque to light and electromagnetic radiation.
  • the micro-piercing members and substrate structure may have transmissions in ranges or bands for particular purposes, or may be optically transparent to light and electromagnetic radiation that enable the insertion sets to be used as described in more detail below.
  • the insertion set 150 may include "rods" or light pipes 152 that are included in the substrate 154 to direct light to the piercing members 156.
  • the light pipes 152 are formed as separate elements out of SiO 2 , A1 2 0 3 , glass, plastic, or the like, and are connected to the substrate 154 by the use of anodic bonding.
  • the piercing members 156 are formed as the light pipes 152.
  • the insertion set may be formed from a single piece of SiO 2 , A1 2 0 3 , glass, plastic, or the like, and are etched to form the substrate and micro-piercing members.
  • the holes may be formed in a part of the micro-piercing members (i.e., on one side of the member - rather than through the exact center) and a part of the substrate. This would simplify manufacturing and avoid very thin tips that might break off when a hole is formed through the exact center of the micro-piercing member.
  • the use of holes may be avoided by the use of porous materials such as porous sintered titanium, porous polyethylene or other such materials. This would permit medications or other fluids to permeate through the substrate to the tissue or from the tissue to the back of the insertion set. It could also simplify manufacturing issues associated with forming holes in either the micro-piercing members and/or the substrate. As illustrated in Fig.
  • an insertion set 10 is formed by a plurality of solid micro-piercing members 12 (or needles) attached to a substrate 14.
  • the micro-piercing members 12 are formed integral with the substrate 14 or formed separately and attached to the substrate 14.
  • the substrate 14 is formed with holes 16, or the holes 16 are drilled, adjacent the micro- piercing members 12.
  • the back of the substrate 14 is covered by a fluid delivery chamber 18, which is in turn coupled to an infusion supply tube 20. Medication is then pumped to the medication chamber 18 and dispersed out the holes 16 in the substrate 14 to permeate into the openings formed in the tissue by the penetration of the micro-piercing members 12 in the tissue.
  • the insertion set 10 may be utilized with a sensor and characteristic monitor, in which fluid is drawn off and supplied to the sensor.
  • Figs. 3 and 4 illustrate an insertion set 30 in accordance with a second embodiment of the present invention that includes an array of micro-piercing members 32 (or needles) formed on a substrate 34.
  • the micro-piercing members 32 are formed with holes 36 passing through the micro-piercing members and the substrate.
  • silicon could be used as the materials, and the micro- piercing members 32 and substrate 34 structure are perforated.
  • a fluid flow connector 38 is attached to the back 40 of the substrate 34 structure.
  • the fluid flow connector 38 is attached to infusion tubing 42 which is attachable to a pump (not shown) to provide fluid communication with the holes 36.
  • the holes 36 do not need to precisely exit the tip 44 (or ends) of the micro-piercing members 32.
  • the insertion set 30 may be utilized with a sensor and characteristic monitor, in which fluid is drawn off and supplied to the sensor.
  • the medication, or other fluid is loaded into the reservoir 54 after insertion of the insertion set to minimize issues of leakage during assembly, storage and transport.
  • the encapsulation material 50 may be a component of an infusion pump that pumps the medication, or other fluid, into the user, such as a wrist watch device, or the like mounted over the encapsulation material 50.
  • the encapsulation material 50 may form a negative pressure reservoir to draw off fluid from the tissue.
  • a suction device (not shown) may be attached to the encapsulation material 50 , where for example, a user uses a valve structure to vent air and then apply suction to the interior of the encapsulation material 50 forming the reservoir 54 to draw off the fluid.
  • the drawn off fluid could be used to determine bodily characteristics with a built in sensor or drawn off fluid could be supplied to a remote sensor.
  • the negative pressure is created in the reservoir 54 after insertion of the insertion set to minimize issues of leakage during assembly, storage and transport.
  • the encapsulation material 50 may contain hydrophilic or wicking material (instead of or in addition to the negative pressure) to draw off fluid from the tissue.
  • the encapsulation material 50 may be divided into sub-regions, in which one region provides fluid to the tissue and the other region withdraws fluid from the tissue.
  • the encapsulation material 50 may be used with ionphoretic medication devices or the like. For example, these types of devices would work more efficiently, since the outer layer of the tissue is already penetrated and fluid flow is easier to facilitate.
  • an insertion set 60 in accordance with third embodiment of the present invention utilizes hollow carbon or glass fibers that form the micro-piercing members 62 (or needles).
  • the micro-piercing members 62 are imbedded in another matrix material to form the substrate 64 to create the insertion set 60.
  • LCP plastic (described above) is a good candidate for forming an insertion set 60 having this structure.
  • ceramics or sintered metals are also suitable for forming the insertion set 60.
  • Figs. 7a and 7b illustrate an insertion set 70 in accordance with a fourth embodiment of the present invention.
  • the insertion set 70 includes micro- piercing members 72 (or needles) that have an outer surface 74 coated with a photo-reactive substance or compound 76 that optically changes, fluoresces, or the like, or other suitable compounds that detect changing properties in the presence of a bodily fluid analyte, such as glucose or the like.
  • the compounds can also be used to detect the level of an analyte that has been ingested, injected or placed inside the body, such as marker substances, or the like.
  • possible compounds, including but not limited to, produce a fluorescent change in the presence of a bodily fluid analyte are disclosed in U.S.
  • the micro-piercing members 72 are coated with the fluorescent material 76 and a substrate 78 is drilled with holes 79 that permit the passage of light L to illuminate the sides of the micro-piercing members 72 to induce a fluorescent reaction in the coated material 76 in the presence of the analyte.
  • the strength (or intensity) of the florescence from the coated material is used to determine the amount of analyte present in the bodily fluid (such as interstitial fluid, blood or the like). In alternative embodiments, lifetime measurements of the fluorescence may be used.
  • the use of exterior coated micro-piercing members 72 is preferred for near continuous monitoring applications, since it is easier for bodily fluids to flow around and be replenished around the outside of the micro-piercing members 72.
  • a second fluorescent compound (not shown) is used as a reference signal and may be placed at one or more locations around the substrate 78. Still further embodiments, may be utilized with an infusion set to determine the level of medication, or fluid being absorbed to determine proper flow rates.
  • preferred embodiments utilize fluorescent compounds to determine a bodily characteristic.
  • alternative embodiments may use other electro-chemical reactions, such as, for example, in diabetes testing, the compounds could be those currently used in conventional blood glucose meters or glucose sensors that use interstitial fluid with glucose oxidase sensors such as those disclosed in U.S. Patent No. 5,391,250 issued February 21, 1995 to Cheney, II et al. and entitled "Method of Fabricating Thin Film Sensors", which is herein incorporated by reference.
  • Other compounds for the detection of viral loads such as in HIV, hepatitis or the like
  • cholesterol levels or other analytes
  • optical analyte materials that measure a change in optical properties of the materials that are sensitive to IR, visible or other forms of radiation may be used.
  • Fig. 8 illustrates an insertion set 80 in accordance with a fifth embodiment of the present invention.
  • the insertion set 80 contains a plurality of coated micro-piercing members 82 (or needles) on a substrate 84 similar to that shown in Figs. 7a and 7b.
  • the holes 86 in the substrate 84 are more conical to allow better illumination of the sides of the coated micro- piercing members 82.
  • a preferred method for forming conical holes 86 is the use of back side etching of the substrate 84, which would be easier than laser drilling. This allows the light L to more directly impinge on the fluorescent compound 88 (or other suitable detection compound), and minimizes reliance on reflection off the tissue.
  • the holes may be cylindrical, like in the earlier embodiments, but formed at an angle to illuminate one side of the micro- piercing members 82. This simplifies manufacturing of the substrate 84, since more conventional manufacturing methods, such as laser drilling may be used.
  • the substrate 84 and/or micro-piercing members 82 are formed from optically transparent materials that permit the light to pass through the substrate 84 and the micro-piercing members 82 to illuminate the fluorescent compound (or other suitable detection compound). This would be advantageous, since it would obviate the need to drill light transmitting holes.
  • Fig. 9 illustrates an insertion set 90 in accordance with a sixth embodiment of the present invention, in which the micro-piercing members 92 (or needles) are formed with the holes 94 passing through the micro-piercing members 92 and a substrate 96.
  • the interior surface 98 of the hollow micro-piercing members 92 is coated with a fluorescent compound 100 (or other suitable detection compound).
  • This embodiment permits easier exposure of the fluorescent compound 100 to light L and minimizes the effects of insufficient illumination or distortion through the substrate 96.
  • This embodiment tends to be more ideally suited for discrete measurements, since it would require ancillary structure to make the fluid flow from the tissue continuously over long periods of time.
  • This embodiment (as well as the embodiments as shown in Figs. 7a-8), could also be used with a fluid delivery system and used to detect back flow of bodily fluids (such as interstitial fluids, blood, or the like), which would indicate a blockage in the infusion supply tubing, or a compound could be used to determine the presence of bacteria and infection developing under the insertion set 90.
  • the coating compound could also be used to detect other contaminates in the fluid flow stream from the infusion supply.
  • Fig. 10 illustrates an insertion set 110 in accordance with a seventh embodiment of the present invention.
  • This embodiment utilizes micro-piercing members 1 12 and a substrate 114 similar to that shown in Fig. 2 (although this embodiment could easily utilize the hollow micro-piercing member structure shown in Fig. 3).
  • the micro-piercing members 1 12 penetrate the tissue, and then the holes 116 in the substrate 114 draw off the interstitial fluid (or other liquid or fluid) by capillary action to a layer of material 1 18 that contains a fluorescent compound, or the like (as discussed above) that responds to the presence of an analyte in the interstitial fluid (or other liquid or fluid).
  • the layer of material 118 may use capillary action to distribute the interstitial fluid (or other liquid or fluid) throughout the layer of material 118.
  • the interstitial fluid or other liquid of fluid
  • the interstitial fluid is pulled from the site by capillary action and wets the fluorescent compound which is then analyzed by a sensor to determine the concentration of the analyte.
  • Figs. 11 and 12A illustrate a self-lancing test strip 120 in accordance with an eighth embodiment of the present invention.
  • the self-lancing test strip 120 uses solid (or hollow) micro-piercing members 122 (or needles) and holes 123 on a substrate 124 coupled via an adhesive or wicking material 126 to an analyte strip 128 that contains a compound that reacts to the presence of an analyte in bodily fluid (such as interstitial fluid, blood or the like) withdrawn from the fluid.
  • the wicking material or adhesive layer 126 may be omitted and the substrate 124 would be directly coupled to the analyte strip 128.
  • a fluorescent compound and detection method is used as described above.
  • the self-lancing test strip harvests interstitial fluid painlessly from the skin for an intermittent reading of the analyte level conventional finger sticks used to determine glucose levels, cholesterol levels or the like.
  • the user taps the self-lancing test strip 120 with the micro-piercing members 122 against the skin to pierce the upper layer and then the interstitial fluid is released from the skin and pulled by capillary action through the holes 123 in the substrate 124.
  • a flexible dome 300 and vent hole 302 are positioned over the skin penetrating portion of the self-lancing test strip 120 to create a negative pressure on the side opposite the micro-piercing members 122 to assist in drawing fluids through the holes 123 in the substrate 124, as shown in Fig. 12B.
  • the self-lancing test strip remains on the skin for a period of time sufficient to withdraw the interstitial fluid, with the time being determined based upon the condition of the user's skin, the temperature, the environmental conditions surrounding the tissue, the type of fluid being withdrawn, the number of micro-piercing membersl22, the number of holes 123, the size of the substrate 124, or the like.
  • the interstitial fluid is drawn into the wicking and/or adhesive layer 126 to evenly wet the compound in the analyte strip 128 above it.
  • the self- lancing test strip 120 is then inserted into a meter (not shown) for analyzing the interstitial fluid using conventional tests, or the fluorescent tests described above.
  • the self-lancing test strip 120 can be left in place on the skin (or tissue), and a test meter can be used to periodically measure the analyte, without the need to remove the self-lancing test strip from the skin.
  • the analyte layer 128 is placed down on any optical device to minimize scratching or abrasion of the optical device by the micro-piercing members 122.
  • the micro-piercing members are hollow and draw the interstitial fluid to the regent through the interior of the micro-piercing members.
  • the micro-piercing members and substrate are formed out of a porous materials to facilitate transfer of the bodily fluid. This may obviate the need for holes in the substrate and/or micro- piercing members.
  • Figs. 16 and 17 illustrate a variation of the embodiments shown in Figs. 10-12, in which an insertion set 170 contains a layer of micro channels 172 between the substrate 174 and the analyte material 176.
  • the micro-channels are "v" shaped and formed from etching of the material forming the layer of micro-channels.
  • the holes 178 in the substrate 174 line up with the intersections 180 of the channels 182 in a first direction and the channels 184 in a second direction.
  • the channels may be at right angles, oblique, acute, or the like to each other.
  • the channels are etched to a few microns depth to promote capillary action to draw the fluid to a collection reservoir 186 that concentrates the collected fluid to provide stronger readings.
  • the micro-channels may be formed on the opposite side of the substrate to improve the diffusion of the collected fluid in the analyte material.
  • the micro-channels may be formed on both sides of the substrate.
  • Figs. 18(a) and 18(b) illustrate a self-lancing test strip 190 similar to the embodiment shown in Figs. 11, 12A and 12B.
  • the embodiment includes a fold- over encapsulating tip 192 to cover the micro-piercing members 194 after use of the test strip 190.
  • the fold- over encapsulating tip includes an adhesive 196 and is folded over to cover the exposed micro-piercing members 194 after the test.
  • the fold-over tip may be stiff enough to be bent away from the micro-piercing members 194 when the test strip 190 is used to avoid premature or accidental contact with the micro-piercing members 194. Then after use, the stiff fold-over tip springs back to cover the micro-piercing members 194.
  • the interior surface of the fold-over tip that contacts the micro- piercing members 194 includes a reflective agent to improve the optical characteristics of the test strip 190, if a reading is taken from the opposite side.
  • Fig. 19 is a cross-sectional view of another insertion set 200 in accordance with an embodiment of the present invention.
  • the holes 202 (or channels) in the substrate 204 and/or micro-piercing members 206 are filled with a hydrophilic material 208 that draws out the fluid from beneath the skin.
  • the hydrophilic material 208 facilitates getting the fluid more quickly and easily to an analyte detection compound 210.
  • the hydrophilic material 208 tends to minimize the ability of the analyte detection compound to contact or migrate into the tissues of the user.

Abstract

L'invention concerne un ensemble d'injection pouvant être utilisé essentiellement pour effectuer une injection sans douleur à travers un tissu, qui comprend un substrat et au moins un élément de micro-perforation, cet élément étant couplé à un substrat afin de former un timbre. L'élément de micro-perforation présente, entre outre, une longueur prédéterminée permettant de percer le matériau à une profondeur prédéterminée afin d'interagir avec le tissu. Selon des modes de réalisation particuliers, l'ensemble d'injection renferme également une structure de commande, qui permet de commander l'écoulement fluidique par rapport au substrat et à l'élément de micro-perforation. De plus, l'ensemble d'injection comprend ou utilise des procédés et des structures qui permettent de maintenir ledit ensemble sur le tissu pendant une durée prédéterminée. La longueur prédéterminée de l'ensemble de micro-perforation est, de préférence, suffisamment longue pour perforer le tissu, et suffisamment courte pour éviter le contact avec des nerfs dans le tissu. L'ensemble d'injection peut également renfermer une structure de commande lumineuse, afin de commander l'entrée de la lumière par rapport au substrat et à l'élément de micro-perforation. Certains types d'ensembles de perforation comprennent un composé de détection d'analyte fluorescent (ou un autre composé de détection) permettant de détecter le niveau d'un analyte dans le tissu, d'autres ensembles d'injection étant des ensembles d'infusion destinés à infuser un liquide dans ledit tissu.
EP99966326A 1998-12-18 1999-12-15 Ensembles d'injection pourvus d'elements de micro-perforation, utilises avec des dispositifs medicaux, et leurs procedes d'utilisation Withdrawn EP1140275A1 (fr)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US11269198P 1998-12-18 1998-12-18
US112691P 1998-12-18
US46012199A 1999-12-13 1999-12-13
US460121 1999-12-13
PCT/US1999/029925 WO2000035530A1 (fr) 1998-12-18 1999-12-15 Ensembles d'injection pourvus d'elements de micro-perforation, utilises avec des dispositifs medicaux, et leurs procedes d'utilisation

Publications (1)

Publication Number Publication Date
EP1140275A1 true EP1140275A1 (fr) 2001-10-10

Family

ID=26810241

Family Applications (1)

Application Number Title Priority Date Filing Date
EP99966326A Withdrawn EP1140275A1 (fr) 1998-12-18 1999-12-15 Ensembles d'injection pourvus d'elements de micro-perforation, utilises avec des dispositifs medicaux, et leurs procedes d'utilisation

Country Status (5)

Country Link
EP (1) EP1140275A1 (fr)
JP (1) JP2002532165A (fr)
AU (1) AU2189400A (fr)
CA (1) CA2352974A1 (fr)
WO (1) WO2000035530A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1086718B1 (fr) * 1999-09-22 2006-11-29 Becton Dickinson and Company Dispositif pour administration transdermique de substance

Families Citing this family (96)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6558351B1 (en) 1999-06-03 2003-05-06 Medtronic Minimed, Inc. Closed loop system for controlling insulin infusion
US6379324B1 (en) 1999-06-09 2002-04-30 The Procter & Gamble Company Intracutaneous microneedle array apparatus
US6629949B1 (en) 2000-05-08 2003-10-07 Sterling Medivations, Inc. Micro infusion drug delivery device
US6659982B2 (en) 2000-05-08 2003-12-09 Sterling Medivations, Inc. Micro infusion drug delivery device
US6565532B1 (en) 2000-07-12 2003-05-20 The Procter & Gamble Company Microneedle apparatus used for marking skin and for dispensing semi-permanent subcutaneous makeup
US6603987B2 (en) * 2000-07-11 2003-08-05 Bayer Corporation Hollow microneedle patch
GB0017999D0 (en) * 2000-07-21 2000-09-13 Smithkline Beecham Biolog Novel device
US6749575B2 (en) 2001-08-20 2004-06-15 Alza Corporation Method for transdermal nucleic acid sampling
EP1315459A1 (fr) * 2000-08-24 2003-06-04 Alza Corporation Methode d'echantillonnage d'acide nucleique transdermique
GB0025147D0 (en) * 2000-10-13 2000-11-29 Torsana Diabetes Diagnostics A Optical sensor for in situ measurement of analytes
US7108681B2 (en) * 2000-10-16 2006-09-19 Corium International, Inc. Microstructures for delivering a composition cutaneously to skin
US7828827B2 (en) 2002-05-24 2010-11-09 Corium International, Inc. Method of exfoliation of skin using closely-packed microstructures
ATE428466T1 (de) 2000-10-26 2009-05-15 Alza Corp Transdermales arzneistoffverabreichungssytem mit beschichteten mikrovorsprüngen
US9302903B2 (en) 2000-12-14 2016-04-05 Georgia Tech Research Corporation Microneedle devices and production thereof
US6663820B2 (en) 2001-03-14 2003-12-16 The Procter & Gamble Company Method of manufacturing microneedle structures using soft lithography and photolithography
MXPA03009603A (es) 2001-04-20 2004-12-06 Johnson & Johnson Arreglo de microproyeccion que tiene un agente benefico que contiene un recubrimiento.
EP1752189A3 (fr) 2001-04-20 2007-02-21 Alza Corporation Réseau de micro-projections avec revêtement contenant un principe bénéfique
US6591124B2 (en) 2001-05-11 2003-07-08 The Procter & Gamble Company Portable interstitial fluid monitoring system
US6840910B2 (en) 2001-08-01 2005-01-11 Johnson & Johnson Consumer Companies, Inc. Method of distributing skin care products
US6790179B2 (en) 2001-08-01 2004-09-14 Johnson & Johnson Consumer Companies, Inc. Method of examining and diagnosing skin health
US6855117B2 (en) 2001-08-01 2005-02-15 Johnson & Johnson Consumer Companies, Inc. Method of treating the skin of a subject
US6501976B1 (en) 2001-06-12 2002-12-31 Lifescan, Inc. Percutaneous biological fluid sampling and analyte measurement devices and methods
US6875613B2 (en) * 2001-06-12 2005-04-05 Lifescan, Inc. Biological fluid constituent sampling and measurement devices and methods
US6837988B2 (en) 2001-06-12 2005-01-04 Lifescan, Inc. Biological fluid sampling and analyte measurement devices and methods
US6721586B2 (en) 2001-06-12 2004-04-13 Lifescan, Inc. Percutaneous biological fluid sampling and analyte measurement devices and methods
US6793632B2 (en) 2001-06-12 2004-09-21 Lifescan, Inc. Percutaneous biological fluid constituent sampling and measurement devices and methods
US6767341B2 (en) * 2001-06-13 2004-07-27 Abbott Laboratories Microneedles for minimally invasive drug delivery
US20030028125A1 (en) * 2001-08-06 2003-02-06 Yuzhakov Vadim V. Physiological sample collection devices and methods of using the same
US6881203B2 (en) * 2001-09-05 2005-04-19 3M Innovative Properties Company Microneedle arrays and methods of manufacturing the same
JP2005503210A (ja) * 2001-09-14 2005-02-03 ザ プロクター アンド ギャンブル カンパニー 回転可能構造を用いて皮膚を介して組成物を皮膚に送達するための微細構造
US6689100B2 (en) * 2001-10-05 2004-02-10 Becton, Dickinson And Company Microdevice and method of delivering or withdrawing a substance through the skin of an animal
US6908453B2 (en) * 2002-01-15 2005-06-21 3M Innovative Properties Company Microneedle devices and methods of manufacture
CA2419200C (fr) * 2002-03-05 2015-06-30 Bayer Healthcare Llc Appareil de prelevement de fluide muni d'une lancette integree et d'une zone de reaction
US7060192B2 (en) * 2002-05-09 2006-06-13 Lifescan, Inc. Methods of fabricating physiological sample collection devices
JP2006500974A (ja) * 2002-06-28 2006-01-12 アルザ・コーポレーシヨン 被覆され微細突起物を有する経皮的薬物送達装置
IL152912A0 (en) * 2002-11-18 2003-06-24 Nanopass Ltd Micro needle systems
US7920906B2 (en) 2005-03-10 2011-04-05 Dexcom, Inc. System and methods for processing analyte sensor data for sensor calibration
US8961477B2 (en) 2003-08-25 2015-02-24 3M Innovative Properties Company Delivery of immune response modifier compounds
US20050107742A1 (en) * 2003-09-15 2005-05-19 The Regents Of The University Of Michigan Shatter-resistant microprobes
US20050080410A1 (en) * 2003-10-14 2005-04-14 Scimed Life Systems, Inc. Liquid infusion apparatus for radiofrequency tissue ablation
US9247900B2 (en) 2004-07-13 2016-02-02 Dexcom, Inc. Analyte sensor
US7282051B2 (en) 2004-02-04 2007-10-16 Boston Scientific Scimed, Inc. Ablation probe for delivering fluid through porous structure
WO2006127694A2 (fr) 2004-07-13 2006-11-30 Dexcom, Inc. Detecteur d'analyte
US7654956B2 (en) 2004-07-13 2010-02-02 Dexcom, Inc. Transcutaneous analyte sensor
SE0402100D0 (sv) 2004-08-30 2004-08-30 Bonsens Ab Molded micro-needles
US7588705B2 (en) * 2004-12-28 2009-09-15 Nabtesco Corporation Skin needle manufacturing apparatus and skin needle manufacturing method
JP2006341089A (ja) * 2005-05-13 2006-12-21 Fujikura Ltd 医薬物運搬用器具およびその製造方法
AU2006336187A1 (en) 2005-12-28 2007-07-26 Alza Corporation Stable therapeutic formulations
US20070156134A1 (en) 2005-12-29 2007-07-05 Boston Scientific Scimed, Inc. Liquid delivery apparatus for tissue ablation
US8657788B2 (en) 2006-02-07 2014-02-25 Tecpharma Licensing Ag Infusion set
EP1820441A1 (fr) * 2006-02-16 2007-08-22 Roche Diagnostics GmbH Réseaux de micro-aiguilles avec capteur de la réflexion totale atténuée (ATR)
US8911749B2 (en) 2007-04-16 2014-12-16 Corium International, Inc. Vaccine delivery via microneedle arrays
WO2008130587A2 (fr) 2007-04-16 2008-10-30 Corium International, Inc. Réseaux de micro-aiguilles coulées dans un solvant contenant un actif
US20120277629A1 (en) 2011-04-29 2012-11-01 Seventh Sense Biosystems, Inc. Systems and methods for collection and/or manipulation of blood spots or other bodily fluids
US9295417B2 (en) 2011-04-29 2016-03-29 Seventh Sense Biosystems, Inc. Systems and methods for collecting fluid from a subject
US20110105951A1 (en) * 2009-10-30 2011-05-05 Seventh Sense Biosystems, Inc. Systems and methods for treating, sanitizing, and/or shielding the skin or devices applied to the skin
WO2012018486A2 (fr) 2010-07-26 2012-02-09 Seventh Sense Biosystems, Inc. Distribution et/ou réception rapide de fluides
US9041541B2 (en) 2010-01-28 2015-05-26 Seventh Sense Biosystems, Inc. Monitoring or feedback systems and methods
EP2408372B1 (fr) * 2009-03-02 2019-01-09 Seventh Sense Biosystems, Inc. Dispositifs associés au prélèvement de sang
US9033898B2 (en) 2010-06-23 2015-05-19 Seventh Sense Biosystems, Inc. Sampling devices and methods involving relatively little pain
EP2482724A2 (fr) 2009-09-30 2012-08-08 Dexcom, Inc. Capteur d'analyte transcutané
AU2011248108B2 (en) 2010-05-04 2016-05-26 Corium Pharma Solutions, Inc. Method and device for transdermal delivery of parathyroid hormone using a microprojection array
US20120016308A1 (en) 2010-07-16 2012-01-19 Seventh Sense Biosystems, Inc. Low-pressure packaging for fluid devices
US20120039809A1 (en) 2010-08-13 2012-02-16 Seventh Sense Biosystems, Inc. Systems and techniques for monitoring subjects
JP5718622B2 (ja) * 2010-08-31 2015-05-13 Ａｓｔｉ株式会社 マイクロニードルアレイ装置
WO2012064802A1 (fr) * 2010-11-09 2012-05-18 Seventh Sense Biosystems, Inc. Systèmes et interfaces pour prélèvement sanguin
EP2646218B1 (fr) * 2010-12-02 2016-04-06 3M Innovative Properties Company Micro-aiguilles de polymère cristallin liquide
ES2597081T3 (es) 2011-04-29 2017-01-13 Seventh Sense Biosystems, Inc. Entrega y/o recepción de fluidos
US20130158468A1 (en) 2011-12-19 2013-06-20 Seventh Sense Biosystems, Inc. Delivering and/or receiving material with respect to a subject surface
JP6145249B2 (ja) * 2012-05-25 2017-06-07 学校法人 関西大学 中空微細針及びその作製方法
GB201213073D0 (en) * 2012-07-23 2012-09-05 Renephra Ltd Microneelde-based devices and methods for the removal of fluid from a body
US10130767B2 (en) 2012-08-30 2018-11-20 Medtronic Minimed, Inc. Sensor model supervisor for a closed-loop insulin infusion system
CN105073178B (zh) 2012-12-21 2019-07-30 考里安国际公司 用于治疗剂递送的微阵列及其使用方法
WO2014105458A1 (fr) 2012-12-27 2014-07-03 3M Innovative Properties Company Article avec micro-aiguilles creuses et procédé de fabrication
WO2014164314A1 (fr) 2013-03-12 2014-10-09 Corium International, Inc. Applicateurs de microprojection
WO2014150285A2 (fr) 2013-03-15 2014-09-25 Corium International, Inc. Applicateurs de microprojection d'impacts multiples et procédés d'utilisation
JP2016512754A (ja) 2013-03-15 2016-05-09 コリウム インターナショナル， インコーポレイテッド 治療剤の送達のためのマイクロアレイ、使用方法および製造方法
EP2968118B1 (fr) 2013-03-15 2022-02-09 Corium, Inc. Microréseau pour l'administration d'un agent thérapeutique et ses procédés d'utilisation
EP2968116A1 (fr) 2013-03-15 2016-01-20 Corium International, Inc. Micro-réseau ayant des microstructures sans polymère, procédés de fabrication et procédés d'utilisation
CA3124578A1 (fr) * 2013-09-30 2015-04-02 Georgia Tech Research Corporation Timbres a micro-aiguilles, systemes et procedes
JP5550775B1 (ja) * 2013-10-01 2014-07-16 合同会社Ｓｙｎｄｅｏ 封入剤送出装置
US9393019B2 (en) * 2013-10-31 2016-07-19 Ethicon, Inc. Therapy delivery device for anastomotic joining of tissue
JP2015100401A (ja) * 2013-11-21 2015-06-04 凸版印刷株式会社 薄膜付針状体パッド、針状体パッドの製造方法
US11083515B2 (en) 2013-12-18 2021-08-10 Novoxel Ltd. Methods and devices for thermal tissue vaporization and compression
JP2017507732A (ja) * 2014-03-10 2017-03-23 スリーエム イノベイティブ プロパティズ カンパニー マイクロニードルデバイス
US10624843B2 (en) 2014-09-04 2020-04-21 Corium, Inc. Microstructure array, methods of making, and methods of use
US10383558B2 (en) 2015-03-06 2019-08-20 Samsung Electronics Co., Ltd. Device for measuring bio information and method for manufacturing the same
US10231736B2 (en) 2015-06-11 2019-03-19 The Regents Of The University Of California System and method for soft tissue gripping
WO2017004067A1 (fr) 2015-06-29 2017-01-05 Corium International, Inc. Micro-réseau pour l'administration d'un agent thérapeutique, procédés d'utilisation, et procédés de fabrication
US20170290535A1 (en) 2016-04-08 2017-10-12 Medtronic Minimed, Inc. Analyte sensor with indicators
FR3054137B1 (fr) * 2016-07-21 2021-08-27 Univ Angers Dispositif medical implantable d’injection locoregionale
JP6977258B2 (ja) * 2016-12-20 2021-12-08 株式会社リコー 中空構造体
WO2019058329A1 (fr) * 2017-09-22 2019-03-28 Sabic Global Technologies B.V. Procédés et systèmes de production de réseaux de micro-aiguilles
FR3097768B1 (fr) * 2019-06-28 2022-11-04 Commissariat Energie Atomique Dispositif de type patch à appliquer sur la peau d'un être vivant
KR102414580B1 (ko) * 2020-07-17 2022-07-01 한국과학기술연구원 수술 전 감염 방지를 위한 마이크로니들 패치 및 마이크로니들 패치를 이용한 수술 전처리 방법
JP7141625B1 (ja) 2021-09-17 2022-09-26 リンテック株式会社 マイクロニードルパッチ及びマイクロニードル構造体

Family Cites Families (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3964482A (en) * 1971-05-17 1976-06-22 Alza Corporation Drug delivery device
US4966159A (en) * 1981-12-14 1990-10-30 Maganias Nicholas H Allergy test strip
EP0081975B1 (fr) * 1981-12-14 1986-11-26 Nicholas H. Maganias Dispositif et procédé pour examiner la réaction allergique
US5512246A (en) 1989-09-21 1996-04-30 Anthony P. Russell Method and means for detecting polyhydroxyl compounds
US5342789A (en) 1989-12-14 1994-08-30 Sensor Technologies, Inc. Method and device for detecting and quantifying glucose in body fluids
US5246867A (en) 1992-01-17 1993-09-21 University Of Maryland At Baltimore Determination and quantification of saccharides by luminescence lifetimes and energy transfer
GB2284809B (en) 1993-11-07 1998-04-29 Japan Res Dev Corp A fluorescent phenylboronic acid suitable for use in the detection of saccharides
US5391250A (en) 1994-03-15 1995-02-21 Minimed Inc. Method of fabricating thin film sensors
DE59505328D1 (de) * 1994-12-09 1999-04-15 Novartis Ag Transdermales system
US5628310A (en) 1995-05-19 1997-05-13 Joseph R. Lakowicz Method and apparatus to perform trans-cutaneous analyte monitoring
WO1996037256A1 (fr) * 1995-05-22 1996-11-28 Silicon Microdevices, Inc. Timbre micromecanique pour ameliorer l'administration de composes a travers la peau
US5665065A (en) * 1995-05-26 1997-09-09 Minimed Inc. Medication infusion device with blood glucose data input
DE19525607A1 (de) * 1995-07-14 1997-01-16 Boehringer Ingelheim Kg Transcorneales Arzneimittelfreigabesystem

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See references of WO0035530A1 *

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1086718B1 (fr) * 1999-09-22 2006-11-29 Becton Dickinson and Company Dispositif pour administration transdermique de substance

Also Published As

Publication number Publication date
CA2352974A1 (fr) 2000-06-22
AU2189400A (en) 2000-07-03
JP2002532165A (ja) 2002-10-02
WO2000035530A1 (fr) 2000-06-22

Similar Documents

Publication Publication Date Title
WO2000035530A1 (fr) Ensembles d'injection pourvus d'elements de micro-perforation, utilises avec des dispositifs medicaux, et leurs procedes d'utilisation
US20220249818A1 (en) Clinical and/or consumer techniques and devices
US20060253085A1 (en) Dual insertion set
EP1471953B1 (fr) Amenagements de micro-aiguilles activees par pression de gaz, systemes et procedes correspondants
US6459917B1 (en) Apparatus for access to interstitial fluid, blood, or blood plasma components
JP4668535B2 (ja) 動物の皮膚を通して物質を供給または引き抜くデバイス
US7258673B2 (en) Devices, systems and methods for extracting bodily fluid and monitoring an analyte therein
CA2787010C (fr) Ensembles de capteur et dispositif de perfusion combines
US8361037B2 (en) Microneedles, microneedle arrays, and systems and methods relating to same
EP1590034B1 (fr) Emplatre a serie de micro-aiguilles
US20090043250A1 (en) Microneedle with membrane
US20090312622A1 (en) Device And Method For Determining A Value Of A Physiological Parameter Of A Body Fluid
US20070004989A1 (en) Device for transdermal sampling
WO2009049823A1 (fr) Cathéter et procédés pour l'utiliser et le fabriquer

Legal Events

Date Code Title Description
PUAI Public reference made under article 153(3) epc to a published international application that has entered the european phase

Free format text: ORIGINAL CODE: 0009012

17P Request for examination filed

Effective date: 20010716

AK Designated contracting states

Kind code of ref document: A1

Designated state(s): AT BE CH CY DE DK ES FI FR GB GR IE IT LI LU MC NL PT SE

AX Request for extension of the european patent

Free format text: AL;LT;LV;MK;RO;SI

RAP1 Party data changed (applicant data changed or rights of an application transferred)

Owner name: MEDTRONIC MINIMED, INC.

RAP1 Party data changed (applicant data changed or rights of an application transferred)

Owner name: MEDTRONIC MINIMED, INC.

17Q First examination report despatched

Effective date: 20030806

GRAP Despatch of communication of intention to grant a patent

Free format text: ORIGINAL CODE: EPIDOSNIGR1

RTI1 Title (correction)

Free format text: INSERTION SETS WITH MICRO-PIERCING MEMBERS FOR USE WITH MEDICAL DEVICES

STAA Information on the status of an ep patent application or granted ep patent

Free format text: STATUS: THE APPLICATION IS DEEMED TO BE WITHDRAWN

18D Application deemed to be withdrawn

Effective date: 20041130