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FI3756657T3 - Nieltävä lääkkeenantolaite - Google Patents

Nieltävä lääkkeenantolaite Download PDF

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Publication number
FI3756657T3
FI3756657T3 FIEP20164025.7T FI20164025T FI3756657T3 FI 3756657 T3 FI3756657 T3 FI 3756657T3 FI 20164025 T FI20164025 T FI 20164025T FI 3756657 T3 FI3756657 T3 FI 3756657T3
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FI
Finland
Prior art keywords
therapeutically effective
therapeutic agent
optionally
effective dose
capsule
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FIEP20164025.7T
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English (en)
Inventor
Mir Imran
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Rani Therapeutics Llc
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=44196421&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=FI3756657(T3) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
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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
    • A61M31/00—Devices for introducing or retaining media, e.g. remedies, in cavities of the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/06—Devices, other than using radiation, for detecting or locating foreign bodies ; Determining position of diagnostic devices within or on the body of the patient
    • A61B5/065—Determining position of the probe employing exclusively positioning means located on or in the probe, e.g. using position sensors arranged on the probe
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/07—Endoradiosondes
    • A61B5/073—Intestinal transmitters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
    • A61B5/14539—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue for measuring pH
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J7/00—Devices for administering medicines orally, e.g. spoons; Pill counting devices; Arrangements for time indication or reminder for taking medicine
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • A61P19/10—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease for osteoporosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/14—Drugs for disorders of the endocrine system of the thyroid hormones, e.g. T3, T4
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/40—Detecting, measuring or recording for evaluating the nervous system
    • A61B5/4076—Diagnosing or monitoring particular conditions of the nervous system
    • A61B5/4094—Diagnosing or monitoring seizure diseases, e.g. epilepsy
    • 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
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
    • A61M5/14276—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body specially adapted for implantation
    • A61M2005/14284—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body specially adapted for implantation with needle insertion means
    • 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
    • A61M31/00—Devices for introducing or retaining media, e.g. remedies, in cavities of the body
    • A61M31/002—Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time
    • 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
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
    • A61M5/14276—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body specially adapted for implantation

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Biomedical Technology (AREA)
  • Physics & Mathematics (AREA)
  • Medical Informatics (AREA)
  • Pathology (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Surgery (AREA)
  • Hematology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Diabetes (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Anesthesiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Optics & Photonics (AREA)
  • Human Computer Interaction (AREA)
  • Dermatology (AREA)
  • Rheumatology (AREA)
  • Endocrinology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Emergency Medicine (AREA)
  • Obesity (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Claims (15)

Patenttivaatimukset
1. Nieltävä laite (10), joka soveltuu nieltäväksi potilaan suoliston luumeniin, jossa luumenissa on luumenin seinämä, ja jolloin laite käsittää kapselin (20), joka on mitoitettu kulkemaan suoliston läpi; kapselin sisään sijoitettua terapeuttisen aineen valmistetta (100), jolloin valmiste käsittää ainakin yhtä terapeuttista ainetta (101), jolloin terapeuttisen aineen valmiste hajoaisi kemiallisesti tai aiheuttaisi haitallisen vaikutuksen potilaalle, jos se vapautuisi suoliston luumenin sisällä, jolloin terapeuttisen aineen valmiste käsittää lisäksi kudosta läpäisevän osan (40), joka sisältää onton — neulan, joka voidaan viedä luumenin seinämän sisään, jolloin ontto neula on muodostettu biohajoavasta materiaalista, jotta se hajoaa suoliston seinämän sisällä; ja toimilaitteen (70a), joka on kytketty terapeuttisen aineen valmisteeseen ja jolla on ensimmäinen ja toinen kokoonpano, jolloin valmiste pysyy kapselin sisällä, kun toimilaite on ensimmäisessä kokoonpanossa, jolloin valmiste viedään kapselista ontelon seinämän sisään liikuttamalla — toimilaite ensimmäisestä kokoonpanosta toiseen kokoonpanoon siten, että terapeuttisen aineen haitallinen vaikutus tai kemiallinen hajoaminen luumenin sisällä estyy, jolloin terapeuttisen aineen terapeuttinen annos sisältyy kapseliin ja jolloin toimilaite on konfiguroitu viemään olennaisesti koko terapeuttisen aineen terapeuttinen annos luumenin seinämän sisään onton neulan avulla, jotta voidaan minimoida kyseinen haitallinen vaikutus.
2. Patenttivaatimuksen 1 mukainen laite, jossa i) valmiste pysyy kokonaan kapselin sisällä, kun toimilaite on ensimmäisessä kokoonpanossa; ja/tai 11) toimilaite sisältää vapautuselementin (70), joka käsittää materiaalia, joka on konfiguroitu — hajoamaan altistuessaan valitulle pH-arvolle suolistossa siten, että hajoamisen yhteydessä valmiste etenee luumenin seinämän sisään.
3. Patenttivaatimuksen 2 mukainen laite, jossa valittu pH on ohutsuolen pH.
4. Patenttivaatimuksen 2 mukainen laite, jossa toimilaite käsittää jousen (80), jolloin vapautuselementti on kytketty jouseen jousen pitämiseksi kokoonpuristetussa tilassa (85) ja se vapauttaa jousen vapautuselementin hajotessa.
5 Patenttivaatimuksen 1 mukainen laite, jossa terapeuttisen aineen valmiste sisältää ainakin ensimmäistä terapeuttista ainetta ja toista terapeuttista ainetta.
6. Patenttivaatimuksen 1 mukainen laite, jossa terapeuttisen aineen valmiste sisältää yhden seuraavista: — a) terapeuttisesti tehokas annos insuliinia diabeteksen tai glukoosinsäätelyhäiriön hoitoon tai b) terapeuttisesti tehokas annos inkretiiniä diabeteksen tai glukoosinsäätelyhäiriön hoitoon, jolloin valinnaisesti inkretiini käsittää glukagonin kaltaisen peptidi-1:n (GLP-1), GLP-1-analogin, eksenatidin, liraglutidin, albiglutidin, taspoglutidin tai mahan inhibitorisen polypeptidin (GIP), tai c) terapeuttisten aineiden yhdistelmä diabeteksen tai glukoosinsäätelyhäiriön hoitoon, jolloin — valinnaisesti yhdistelmä käsittää terapeuttisesti tehokkaan annoksen inkretiiniä ja terapeuttisesti tehokkaan annoksen biguanidia, jolloin valinnaisesti 1) inkretiini käsittää eksenatidin ja biguanidi metformiinin tai 11) inkretiinin ja biguanidin annokset täsmäytetään niin, että saadaan parempi verensokerin hallinta pitkäksi aikaa, tai — d) terapeuttisesti tehokas annos kasvuhormonia tai e) terapeuttisesti tehokas annos lisäkilpirauhashormonia osteoporoosin tai kilpirauhasen häiriön hoitoon tai f) terapeuttisesti tehokas annos solunsalpaajaa syövän hoitoon tai g) terapeuttisesti tehokas annos antibioottia tai b) terapeuttisesti tehokas annos viruslääkeyhdistettä, jolloin valinnaisesti viruslääkeyhdiste käsittää proteaasinestäjää, tai i) terapeuttisesti — tehokas — annos — kohtauksenestoyhdistettä, — jolloin — valinnaisesti kohtauksenestoyhdiste käsittää furosemidin.
7. Patenttivaatimuksen 6 mukainen terapeuttisen aineen valmiste, jossa insuliinin, eksenatidin, liraglutidin, kasvuhormonin ja lisäkilpirauhashormonin terapeuttisesti tehokkaat annokset ovat seuraavilla vaihteluväleillä: a) insuliinin osalta noin 1-10 yksikköä, valinnaisesti 2-4, 3-9, 4-9, 5-8 tai 6-7 yksikköä, jolloin — yksi yksikkö on biologinen vastine noin 45,5 ug:lle puhdasta kiteistä insuliinia b) eksenatidin osalta noin 1-10 pg, valinnaisesti 2-4, 4-6, 4-8 ja 8-10 ug c) liraglutidin osalta noin 1-2 mg, valinnaisesti 1,0-1,4 mg, 1,2-1,6 mg ja 1,2-1,8 mg e) kasvuhormonin osalta noin 0,1—4 mg, valinnaisesti 0,1-1, 1-4, 1-2 ja 2-4 mg; ja f) lisäkilpirauhashormonin osalta noin 1-40 ug, valinnaisesti 10-20, 20-30, 30—40 ja 10-40 pg.
8. Patenttivaatimuksen 6 tai 7 mukainen terapeuttisesti tehokas insuliiniannos, jossa insuliini on ihmisperäistä tai synteettisesti johdettua.
9. Patenttivaatimuksen 6 osan i) mukaisten terapeuttisten aineiden yhdistelmä, jossa eksenatidin — terapeuttisesti tehokas annos on noin 1-10 ug ja metformiinin terapeuttisesti tehokas annos on noin 1-3 g.
10. Patenttivaatimuksen 1 mukainen laite, jossa kapseli on muodostettu biohajoavasta materiaalista, jotta se hajoaa kokonaan tai osittain suolistossa.
11. Patenttivaatimuksen 1 tai 10 mukainen laite, jossa kapseli sisältää enteropäällysteen tai muun pinnoitteen kapselin suojaamiseksi mahahapoilta ja samalla sen ohutsuolessa tapahtuvan biohajoamisen sallimiseksi.
12. Patenttivaatimuksen 1 mukainen laite, jossa toimilaite käsittää lisäksi laajenevan osan.
13. Patenttivaatimuksen 12 mukainen laite, jossa laajeneva osa käsittää ballongin, jolloin ballonki sisältää ensimmäisen osion ja toisen osion, jotka on erotettu toisistaan erotusventtiilillä, jolloin ensimmäiseen osioon on sijoitettu nestettä ja toiseen osioon on sijoitettu ainakin yhtä reagoivaa — ainetta.
14. Patenttivaatimuksen 13 mukainen laite, jossa erotusventtiili on konfiguroitu hajoamaan ohutsuolen pH:n mukaan siten, että venttiili avautuu hajoamisen yhteydessä.
15. Patenttivaatimuksen 13 tai 14 mukainen laite, jossa venttiilin avautuessa kyseinen ainakin yksi reagoiva aine sekoittuu nesteeseen muodostaen kaasua, joka laajentaa ballonkia ja vie kudosta läpäisevän osan luumenin seinämän sisään.
FIEP20164025.7T 2009-12-24 2010-12-23 Nieltävä lääkkeenantolaite FI3756657T3 (fi)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US28476609P 2009-12-24 2009-12-24
US34033110P 2010-03-15 2010-03-15
US39530410P 2010-05-10 2010-05-10

Publications (1)

Publication Number Publication Date
FI3756657T3 true FI3756657T3 (fi) 2025-05-30

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ID=44196421

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Application Number Title Priority Date Filing Date
FIEP20164025.7T FI3756657T3 (fi) 2009-12-24 2010-12-23 Nieltävä lääkkeenantolaite

Country Status (11)

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EP (4) EP4056173B1 (fi)
JP (7) JP2013515576A (fi)
CN (2) CN102905753B (fi)
AU (5) AU2010336330B2 (fi)
CA (1) CA2785168C (fi)
DK (3) DK3756657T3 (fi)
ES (2) ES2804716T3 (fi)
FI (1) FI3756657T3 (fi)
PL (2) PL3756657T3 (fi)
PT (1) PT3756657T (fi)
WO (1) WO2011079302A2 (fi)

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