Intrauterine system

Patent metadata

Field	Value
Publication number	US-9949869-B2
Application number	US-201013499701-A
Country	US
Kind code	B2
Filing date	Sep 30, 2010
Priority date	Oct 1, 2009
Publication date	Apr 24, 2018
Grant date	Apr 24, 2018

Abstract

The present invention relates to novel intrauterine systems and to methods for manufacturing these systems. An intrauterine system according to the invention comprises a reservoir and a continuous, closed and flexible frame. The frame comprises a thermoplastic polyurethane elastomer made of a polycarbonate diol, 1,6-hexamethylenediisocyanate, and a chain extender.

First claim

The invention claimed is:

1. An intra-uterine system for a long-term insertion into a uterine cavity comprising:
a rectangular reservoir; and
a continuous, closed and flexible frame of a polygonal shape,
wherein a first end of the reservoir is connected to an inner surface of the frame, the reservoir comprises at least one therapeutically active substance and the frame comprises a thermoplastic polyurethane elastomer comprising the reaction product of:
a) an isocyanate component comprising:
a1) from 80 to 100 mol. % of 1,6-hexamethylene diisocyanate

b) a polyol component comprising a polycarbonate diol that is prepared from 1,6-hexanediol and dimethyl carbonate,
c) a chain extender component comprising:
c1) from 35 to 95 mol. % of at least one difunctional chain extender selected from 1,2-ethanediol, 1,3 propanediol, 1,4-butanediol, 1,6-hexanediol, 1,8-octanediol, 1,10-decanediol, 1,12-dodecanediol or hydroquinone bis-2-hydroxyethyl ether (HQEE) and mixtures of a straight chain oligomer, prepared from 1,6-hexanediol and ϵ-caprolactone, and hydroquinone bis-2-hydroxyethyl ether (HQEE), and
c2) from 5 to 65 mol. % of a chain extender selected from 1,2-ethanediol, 1,3-propanediol, 1,4-butanediol, 1,6-hexanediol, 1,8-octanediol, 1,10-decanediol, 1,12-dodecanediol or hydroquinone bis-2-hydroxyethyl ether (HQEE) and mixtures of a straight chain oligomer, prepared from 1,6-hexanediol and ϵ-caprolactone, and hydroquinone bis-2-hydroxyethyl ether (HQEE) which is different from the difunctional chain extender of c1

in the presence of
d) one or more catalysts selected from, bismuth neodecanoate, bismuthoctoate, bismuth carboxylate (BiCat), stannous diacetate, stannous dioctoate, stannous dilaurate, or dibutyltin diacetate, dibutyltin dilaurate, dibutyltin dioctoate, titanic esters or ferric acetylacetonate,
with the addition of
e from 0.1 to 35 wt. %, based on the weight of the thermoplastic polyurethane made

of components a) to d), of inorganic fillers, and
f further additives or auxiliary substances in which the ratio of the isocyanate groups of a) to isocyanate-reactive groups of b), and c) is from 0.9:1 to 1.1:1;
wherein the thermoplastic polyurethane elastomer has at least one of a degree of stiffness that is greater than 8 N/mm2 at 100% elongation, a high hardness of Shore D>40 and <55, and a rebound of greater than 30%.

2. An intrauterine system according to claim 1 , characterized in that the chain extender component is a mixture of hydroquinone bis(2-hydroxyethyl)ether and a straight chain oligomer prepared from 1,6-hexanediol and -caprolactone.

3. An intrauterine system according to claim 1 , characterized in that the chain extender component is 1, 12-dodecane diol.

4. An intrauterine system according claim 1 , characterized in that the frame is essentially triangular or pentagonal.

5. An intra-uterine system according to claim 1 , characterized in that the cross section of the frame is circular, semi-circular, oval, flat, elliptical, rectangular, angular, polygonal or star-shaped.

6. An intra-uterine system according to claim 1 , characterized in that both the first end and a second end end-of the reservoir are connected to the inner surf ace of the frame.

7. An intra-uterine system according to claim 1 , characterized in that the cross section of the reservoir is circular, oval, flat, elliptical, rectangular, angular, polygonal or star-shaped.

8. An intra-uterine system according to claim 1 , characterized in that the reservoir comprises at least one core.

9. An intra-uterine system according to claim 8 , characterized in that at least one of the cores of the reservoir is encased by a polymer layer.

10. An intra-uterine system according to claim 9 , characterized in that the polymer layer includes a polymer composition and the polymer composition of said at least one core and the polymer layer encasing the core are the same or different.

11. An intra-uterine system according to claim 1 , characterized in that the frame comprises a supporting means consisting of a polymer composition or a biocompatible metal.

Assignees

• Tjaeder Taina
• Calvo Alonso Ulla
• Inki Pirjo
• Jukarainen Harri
• Jutila Ilkka
• Kortesuo Pirjo
• Lehtinen Juha
• Lukkari Lax Eeva
• Lyytikaeinen Heikki
• Moede Joachim
• Nikander Hannu
• Sallinen Pirjo
• Shafiq Faisal
• Kaufhold Wolfgang
• Wamprecht Christian
• Bayer Oy

Inventors

• Tjäder Taina
• Calvo Alonso Ulla
• Inki Pirjo
• Jukarainen Harri
• Jutila Ilkka
• Kortesuo Pirjo
• Lehtinen Juha
• Lukkari-Lax Eeva
• Lyytikäinen Heikki
• Moede Joachim
• Nikander Hannu
• Sallinen Pirjo
• Shafiq Faisal
• Kaufhold Wolfgang
• Wamprecht Christian

Classifications

• A61P15/18

  Feminine contraceptives · CPC title

• A61P15/08

  for gonadal disorders or for enhancing fertility, e.g. inducers of ovulation or of spermatogenesis · CPC title

• A61K9/00

  Medicinal preparations characterised by special physical form {(nuclear magnetic resonance contrast preparations or magnetic resonance imaging contrast preparations A61K49/18; preparations containing radioactive substances A61K51/12)} · CPC title

• A61F6/142 Primary

  Wirelike structures, e.g. loops, rings, spirals · CPC title

• A61K9/0039

  Devices retained in the uterus for a prolonged period, e.g. intrauterine devices for contraception · CPC title