WO2010112095A1 - Amélioration apportée à des dispositifs contraceptifs intra-utérins en cuivre - Google Patents

Amélioration apportée à des dispositifs contraceptifs intra-utérins en cuivre Download PDF

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Publication number
WO2010112095A1
WO2010112095A1 PCT/EP2009/067709 EP2009067709W WO2010112095A1 WO 2010112095 A1 WO2010112095 A1 WO 2010112095A1 EP 2009067709 W EP2009067709 W EP 2009067709W WO 2010112095 A1 WO2010112095 A1 WO 2010112095A1
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WO
WIPO (PCT)
Prior art keywords
copper
hollow
iud
previous
iud according
Prior art date
Application number
PCT/EP2009/067709
Other languages
English (en)
Inventor
Dirk Wildemeersch
Original Assignee
Bio Material Systems Nv/Sa
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 Bio Material Systems Nv/Sa filed Critical Bio Material Systems Nv/Sa
Publication of WO2010112095A1 publication Critical patent/WO2010112095A1/fr
Priority to CA2784602A priority Critical patent/CA2784602A1/fr
Priority to PCT/EP2010/070434 priority patent/WO2011080164A1/fr
Priority to RU2012130602/14A priority patent/RU2555389C2/ru
Priority to US13/518,078 priority patent/US20120318276A1/en
Priority to EP10805786.0A priority patent/EP2515806B1/fr
Priority to CN201080058690.6A priority patent/CN102781377B/zh
Priority to ZA2012/05024A priority patent/ZA201205024B/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F6/00—Contraceptive devices; Pessaries; Applicators therefor
    • A61F6/06—Contraceptive devices; Pessaries; Applicators therefor for use by females
    • A61F6/14—Contraceptive devices; Pessaries; Applicators therefor for use by females intra-uterine type
    • A61F6/142—Wirelike structures, e.g. loops, rings, spirals

Definitions

  • the invention relates to a new and improved "frameless" copper-releasing intrauterine contraceptive device (IUD).
  • IUD intrauterine contraceptive device
  • Such a known device comprises copper cylinders and is very efficient as the inner surface of the copper cylinders is in contact with the uterine environment, thereby increasing the effective copper surface area.
  • IUDs An important drawback of IUDs is indeed their tendency to cause heavy, sometimes painful, menstrual bleeding. Heavy bleeding is the commonest cause for IUD discontinuation. Discontinuation rates for bleeding vary from 7.0 to 12.0 during the first year of use. In the USA, an estimate of 36% of IUD users terminate during the first year for reasons other than the desire for pregnancy, including heavy menstrual bleeding and pain. Heavy menstrual bleeding may have a deleterious effect on health among normally healthy women. This is especially the case in women living in deprived developing countries where increased menstrual blood loss may precipitate or aggravate iron deficiency anaemia. It has been reported that even minute increases in menstrual blood loss may adversely affect the health of women especially during long-term use of IUD contraception.
  • Anaemia is common according to a recent report of the WHO (World Health Organization) report on the worldwide incidence of anaemia. According to this report, the incidence of anaemia in Western Europe and the USA is about 8%, in the older Eastern European countries about 20-30%, South America about 20-30%.
  • MBL menstrual blood loss
  • the purpose of the present invention is also to provide a frameless IUD which lasts for approximately years 25 years instead of 10 years. Due to the fact that the IUD consists of copper cylinders, the total weight of the copper can be increased thereby increasing the lifespan of the IUD by many years and at the same time reducing the risk of fragmentation of the copper which could increase the risk of pregnancy.
  • the primary aim of the present invention is to provide a copper IUD which has a smaller total surface area but a large effective copper surface area, when compared to the effective copper surface area of the high-load conventional copper IUDs, and of which the total surface area of the foreign body is at least two or three times smaller than that of conventional copper releasing IUDs in order to minimize the impact on menstrual blood loss.
  • an IUD of extremely small dimensions wherein the active substance is preferably copper, and wherein the components are hollow and attached to each other one behind the other in a non-rigid assembly and wherein the such components, elements or members are sufficiently short allowing the inner surface of the cylinders to come into contact with the uterine environment.
  • the total surface area of the IUD does not exceed 275 mm2. According to one embodiment it will not exceed 250 mm2.
  • the effective copper surface area equals the nominal copper surface area which should be at least 200 mm2.
  • the components are copper cylinders and are not longer than 6 to 8 mm in order to allow easier direct contact between the inner surface of the cylinders and the uterine environment.
  • all copper cylinders are hollow and are kept in place by two small copper clips, one above and one below the copper cylinders, crimped or flattened onto the anchoring thread.
  • the clips may be cylinders identical to the copper cylinders but which have been crimped. The design of the device and the manufacturing process may therefore be simplified.
  • the total length of the closely approximated copper elements of the IUD is not longer than 2.6 cm.
  • the total length of the IUD is not longer than 3.0 cm when the copper elements are separated.
  • the hollow elements are separated from each other by a small space to enhance the contact between the inner part of the cylinders and the uterine environment.
  • the hollow elements are not larger than 3.0 mm in diameter in order to allow easy insertion in the uterine cavity.
  • the inner diameter of the hollow elements is at least 1.6 mm in diameter to allow a high total (inner and outer) effective copper surface area similar to high-load copper IUDs.
  • the wall of the hollow elements is partly cut out to allow enhanced exchange between the inner surface area of the copper elements and the uterine environment.
  • the elements are provided with side holes to increase the contact between the inner surface of the elements and the uterine environment.
  • the goals in connection with lifetime of the device are also reached, according to the present invention, by creating an IUD of extremely small dimensions, consisting of hollow copper cylinders of which the wall thickness is increased to increase the copper load and consequently the lifespan of the device.
  • the hollow, preferably but not necessarily copper, components are attached to each other one behind the other in a non-rigid assembly and of which the elements are sufficiently short allowing the inner surface of the cylinders to come into contact with the uterine environment.
  • the preferred mode of realization is a frameless IUD consisting of 4 copper tubes, with outer diameter of 2.4 mm and an inner diameter of 1.6 mm, which are threaded on a length of suture material and of which the upper and lower copper tubes are crimped onto the thread to prevent sliding off the suture thread.
  • the proximal end of the thread is provided with a knot which serves as retaining member to keep the device affixed to the uterine wall.
  • the thread should have at least a 0-gauge size to maintain retention of the heavier IUD attached to the uterine wall .
  • the outer diameter of the copper cylinders should not exceed 2.8 mm to allow easy insertion in the uterus.
  • the inner diameter of the copper cylinders should not be less than 1.6 mm to allow proper copper ion exchange with the uterine environment.
  • the number of elements may be between 2 and 10, preferably between 3 to 6. Particularly preferred is a structure comprising 4 cylindrical elements, each approximately 5 mm in length, in a row of which the first and last have been crimped onto the anchoring thread.
  • the hollow elements are preferably made of copper.
  • the fixation means is an anchor made advantageously by heat-deformation of the end of a loop made in an anchoring (thermoplastic) thread whereby the end is essentially spherical and wherein one string is cut short to form a hook or appendix, adding to the functionality of the anchor.
  • the anchor may comprise a tubular metal element at the appendix fixedly attached to this appendix allowing better visibility of the anchor at examination by ultrasound.
  • the anchor may also comprise a thin tube which is threaded onto the anchoring thread up to the body of the anchor to allow the anchor to be inserted with a forceps into the musculature of the uterine fundus.
  • the hollow elements are preferably made of copper or of biocompatible stainless steel.
  • gold is added in addition to the spermicidal action of copper. It has indeed been shown that copper and gold (or silver) enter into a electrochemical reaction.
  • the alloy of copper and noble metal (silver, gold) creates a multitude of local tiny galvanic (alkaline) batteries when in contact with the uterine environment (which serves as an electrolyte) . Copper act as an anode, while the noble metals (Ag, Au) serve as cathode.
  • the resulting weak electrical activity has a negative effect on sperm cell motility, capacitation and survival, while the foreign body reaction, also stimulated electrically, increases leucocyte infiltration in the endometrium and further increases the number of macrophages in the uterine cavity (enhanced spermicidal effect) .
  • Silver and gold ions dissolved in trace quantities, exhibit in situ bactericidal and fungicidal effects (oligodynamic effects), which are expected to lessen the risk of pelvic inflammatory disease (infection) .
  • gold tubes with length varying between 1.6 and 2.0 mm are added between the copper tubes of the small IUD (GyneFix type) at three possible locations : first, below the first "crimped” copper tube; second, between the “loose” copper tubes; and thirdly above the lower “crimped” copper tube.
  • Another mode of realization is to crimp onto the suture thread one short 2.5-3.0 mm gold tube above and one below the 4 copper tubes DESCRIPTION OF THE DRAWINGS
  • FIG. 1 is a schematic cross sectional view of the uterus with a preferred embodiment of an IUD according to the invention
  • FIG. 2 represents a view of a preferred embodiment of an IUD according to the invention, compared with a conventional copper-T IUD, showing the significant difference in size between the two IUDs,
  • FIG. 3 is a transversal sectional view of an element of the invention
  • FIG. 4 is another view of an embodiment according to the invention of which the elements are separated from each other to enhance the contact between the inner surface of the hollow cylinders and the uterine fluid,
  • FIG. 5 represents another view of embodiments according to the invention of which the elements are cut out longitudinally or laterally to enhance the contact with the uterine environment.
  • FIG. 6 represents another view of an embodiment according to the invention of which the elements are perforated to enhance the contact with the uterine environment .
  • FIG. 7 represents another view of an embodiment wherein the elements are perforated and comprise a cut out .
  • FIG.8 is an enlarged view of the thread anchor provided with a thin tube which is threaded just below the anchoring knot.
  • FIG. 9 represents the anchor as in Fig. 8 provided with an additional tube which is threaded onto the appendix of the anchor.
  • an IUD is made of a material which is physiologically active in the uterine cavity, consisting of 4 hollow longitudinal members, 2 open at both ends, and arranged in a sequence in order to form a longitudinal flexiblebody .
  • the elements are threaded on a length of thread, for example a polypropylene suture material.
  • the sleeve members or elements (2) are prevented from sliding off the material by the upper and lower sleeves which are at least partially crimped onto the thread.
  • the proximal end of the thread is provided with a fixing means 5 to secure the IUD in the fundal part of the uterine cavity 1 and prevent expulsion.
  • This device has no rigid plastic body, making it a completely flexible unit.
  • the IUD is made of hollow elements of which the total surface area is at least two times smaller when compared with a well-known conventional IUD (TCu380A ) as shown in FIG . 2 .
  • FIG. 3 is a transversal sectional view of an element of the invention, showing the possibility of exchange of contact between the inner surface of the hollow cylinders and the uterine fluid.
  • FIG. 4 is a cross sectional view according to one embodiment with a retaining member 5 at the upper end of the thread
  • the hollow elements, open at both ends, are separated from each other by a spacer 4 being provided crimped or not onto the thread, in order to enhance the contact with the uterine environment.
  • FIG. 5A and 5B are sectional views illustrating a particular embodiment of the hollow elements 52 being provided with cut outs 56, 57 (longitudinal or transversal) to enhance the contact with the uterine environment
  • FIG. 6 and FIG. 7 show other embodiments of a hollow element 62 which is perforated and another element which is provided with holes and is also partly cut out 72,78 to enhance the contact with the uterine environment 11.
  • FIG. 8 show an embodiment of the anchoring means different from the one illustrated in Fig. 4. The enlarged detail shows a knot 80, a loop 81, an appendix 82 and a tube 83 narrowly threaded on the thread 3 of the device.
  • FIG. 9 is a similar view with an additional tube 94 threaded and fixed to the appendix to facilitate detection by ultrasound techniques.
  • the new advantageous embodiments illustrated in Figs. 8 and 9 are applicable separately and are applicable also to any intra-uterine device requiring anchoring means to the fundus or device similar to but having not the dimensional features of the present claim 1. Therefore, the invention concerns also an intrauterine contraceptive device (IUD) comprising: a plurality of hollow, metabolically active elements, open at both ends and arranged longitudinally onto a thread 3, one end of which comprises an anchoring means, with a knot in said thread, to retain to the fundal part of the uterine cavity, such device forming a non-rigid structure of limited dimensions, wherein there is provided a further crimped hollow member or thin tube which is threaded just below the anchoring knot and/or there is provided a further crimped hollow member at the appendix of the anchoring means.
  • IUD intrauterine contraceptive device

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  • Health & Medical Sciences (AREA)
  • Reproductive Health (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Orthopedics, Nursing, And Contraception (AREA)

Abstract

L'invention concerne un dispositif contraceptif intra-utérin (IUD) comprenant une pluralité de trous, et un élément métaboliquement actif (2) ouvert aux deux extrémités et agencé de manière longitudinale sur un fil (3) afin de former une structure non rigide de dimensions limitées. La structure présente une zone de surface totale qui n'excède pas 275 mm2. La longueur de la structure est inférieure à 2,6 cm lorsque les éléments de cuivre sont approximativement rapprochés et inférieure ou égale à 3,0 cm lorsqu'ils sont séparés, son diamètre étant inférieur ou égal à 3,30 mm, et de préférence inférieur ou égal à 3.00 mm. Les éléments creux présentent un diamètre intérieur d'au moins 1,6 mm et une longueur égale ou inférieure à 8 mm. Les éléments creux sont éventuellement partiellement découpés et/ou perforés.
PCT/EP2009/067709 2009-04-03 2009-12-21 Amélioration apportée à des dispositifs contraceptifs intra-utérins en cuivre WO2010112095A1 (fr)

Priority Applications (7)

Application Number Priority Date Filing Date Title
CA2784602A CA2784602A1 (fr) 2009-12-21 2010-12-21 Ameliorations apportees aux dispositifs et systemes intra-uterins sans armature
PCT/EP2010/070434 WO2011080164A1 (fr) 2009-12-21 2010-12-21 Améliorations apportées aux dispositifs et systèmes intra-utérins sans armature
RU2012130602/14A RU2555389C2 (ru) 2009-12-21 2010-12-21 Усовершенствование в бескаркасных внутриматочных устройствах и системах
US13/518,078 US20120318276A1 (en) 2009-12-21 2010-12-21 Frameless intrauterine devices and systems
EP10805786.0A EP2515806B1 (fr) 2009-12-21 2010-12-21 Améliorations apportées aux dispositifs et systèmes intra-utérins sans cadre
CN201080058690.6A CN102781377B (zh) 2009-12-21 2010-12-21 无框宫内装置和系统的改进
ZA2012/05024A ZA201205024B (en) 2009-12-21 2012-07-05 Improvements to frameless intrauterine devices and systems

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP09100222.0 2009-04-03
EP09100222 2009-04-03

Publications (1)

Publication Number Publication Date
WO2010112095A1 true WO2010112095A1 (fr) 2010-10-07

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Application Number Title Priority Date Filing Date
PCT/EP2009/067709 WO2010112095A1 (fr) 2009-04-03 2009-12-21 Amélioration apportée à des dispositifs contraceptifs intra-utérins en cuivre

Country Status (1)

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WO (1) WO2010112095A1 (fr)

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20140283844A1 (en) * 2011-10-28 2014-09-25 Sujoy Kumar Guha Intra-Uterine Contraceptive Device
US9668912B2 (en) 2008-09-17 2017-06-06 Bayer Oy Inserter
US10561524B2 (en) 2008-09-17 2020-02-18 Bayer Oy Inserter
US11432958B2 (en) 2008-09-17 2022-09-06 Bayer Oy Inserter
US11992431B2 (en) 2008-09-17 2024-05-28 Bayer Oy Inserter

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0147274A1 (fr) * 1983-12-01 1985-07-03 BIOMASYS Société dite: Perfectionnements apportés aux dispositifs intra-utérins
EP0191747A1 (fr) 1985-02-05 1986-08-20 Dirk Wildemeersch Dispositif anticonceptionnel intra-utérin nouveau et perfectionné et son dispositif d'insertion et de fixation de la matrice
US4949732A (en) * 1989-08-24 1990-08-21 Gyno Pharma Inc. Apparatus for insertion and fixation of an intra uterine contraceptive device to the uterine fundus
WO1990009158A1 (fr) * 1989-02-07 1990-08-23 Radelkis Elektrokémiai Mu^'szergyártó Ipari Szövetkezet Dispositif contraceptif intra-uterin
EP0673629A1 (fr) * 1994-03-16 1995-09-27 Willem Arthur Adriaan Van Os M.D. Ph. D. Dispositif contraceptif intra-utérin
US6742520B1 (en) * 1999-05-07 2004-06-01 Dirk Wildemeersch Intrauterine contraceptive device

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0147274A1 (fr) * 1983-12-01 1985-07-03 BIOMASYS Société dite: Perfectionnements apportés aux dispositifs intra-utérins
EP0191747A1 (fr) 1985-02-05 1986-08-20 Dirk Wildemeersch Dispositif anticonceptionnel intra-utérin nouveau et perfectionné et son dispositif d'insertion et de fixation de la matrice
US4708134A (en) 1985-02-05 1987-11-24 Wildemeersch Dirk A A Intrauterine contraceptive device and device for its insertion and fixation to the uterus
WO1990009158A1 (fr) * 1989-02-07 1990-08-23 Radelkis Elektrokémiai Mu^'szergyártó Ipari Szövetkezet Dispositif contraceptif intra-uterin
US4949732A (en) * 1989-08-24 1990-08-21 Gyno Pharma Inc. Apparatus for insertion and fixation of an intra uterine contraceptive device to the uterine fundus
EP0673629A1 (fr) * 1994-03-16 1995-09-27 Willem Arthur Adriaan Van Os M.D. Ph. D. Dispositif contraceptif intra-utérin
US6742520B1 (en) * 1999-05-07 2004-06-01 Dirk Wildemeersch Intrauterine contraceptive device

Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9668912B2 (en) 2008-09-17 2017-06-06 Bayer Oy Inserter
US10561524B2 (en) 2008-09-17 2020-02-18 Bayer Oy Inserter
US10987244B2 (en) 2008-09-17 2021-04-27 Bayer Oy Inserter
US11432958B2 (en) 2008-09-17 2022-09-06 Bayer Oy Inserter
US11850182B2 (en) 2008-09-17 2023-12-26 Bayer Oy Inserter
US11872155B2 (en) 2008-09-17 2024-01-16 Bayer Oy Inserter
US11911312B2 (en) 2008-09-17 2024-02-27 Bayer Oy Inserter
US11992431B2 (en) 2008-09-17 2024-05-28 Bayer Oy Inserter
US20140283844A1 (en) * 2011-10-28 2014-09-25 Sujoy Kumar Guha Intra-Uterine Contraceptive Device

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