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WO2005006991A2 - Dispositif et procede pour l'occlusion des trompes de fallope - Google Patents

Dispositif et procede pour l'occlusion des trompes de fallope Download PDF

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Publication number
WO2005006991A2
WO2005006991A2 PCT/IE2004/000098 IE2004000098W WO2005006991A2 WO 2005006991 A2 WO2005006991 A2 WO 2005006991A2 IE 2004000098 W IE2004000098 W IE 2004000098W WO 2005006991 A2 WO2005006991 A2 WO 2005006991A2
Authority
WO
WIPO (PCT)
Prior art keywords
catheter
medical device
occluding compound
fallopian tube
occluding
Prior art date
Application number
PCT/IE2004/000098
Other languages
English (en)
Other versions
WO2005006991A3 (fr
WO2005006991B1 (fr
Inventor
Martin Gerard Caldwell
Donal Bermingham
Anne O'brien
Philip O'malley
Noeleen Swords
Kenneth Norman Broadley
James Coleman
Christopher Cummins
Original Assignee
Chiroxia Limited
Henkel Loctite (Ireland) Limited
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 Chiroxia Limited, Henkel Loctite (Ireland) Limited filed Critical Chiroxia Limited
Publication of WO2005006991A2 publication Critical patent/WO2005006991A2/fr
Publication of WO2005006991A3 publication Critical patent/WO2005006991A3/fr
Publication of WO2005006991B1 publication Critical patent/WO2005006991B1/fr

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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
    • A61F6/20—Vas deferens occluders; Fallopian occluders
    • A61F6/22—Vas deferens occluders; Fallopian occluders implantable in tubes
    • A61F6/225—Vas deferens occluders; Fallopian occluders implantable in tubes transcervical
    • 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
    • A61M31/007—Injectors for solid bodies, e.g. suppositories
    • 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
    • A61M2210/00—Anatomical parts of the body
    • A61M2210/14—Female reproductive, genital organs
    • A61M2210/1425—Uterine tubes

Definitions

  • the invention relates to a device and method for occluding the fallopian tubes of a female human or animal subject.
  • the present invention relates to a transcervical device for delivering an occluding compound in liquid form to the fallopian tubes.
  • transabdominal procedures are the procedure of choice.
  • laparoscopic sterilization is the most commonly performed surgical procedure for permanent sterilization. At present, over 9 million such procedures are carried out each year worldwide with 750,000 in the United States alone. While highly efficient these sterilization methods are associated with substantial trauma and generally involve attendance at a hospital facility, general anesthesia and a stay over with the associated costs. Complications are also a known issue, which may include bleeding, bowel perforation, infection and cosmetic trauma. More recently transcervical sterilization has been the subject of much interest. This approach uses the female reproductive route as the means of access so avoiding incisional surgery. A further attraction is the ability to perform the procedure on an outpatient or office basis. In doing so it is envisaged the cost savings will be substantial. Additionally the procedure will be done with local or no analgesics and at greater convenience for the physician and patient.
  • Examples of mechanical techniques include the OVABLOCTM and more recently the MIRENA COILTM and the CONCEPTUS ESSURETM device.
  • OVABLOCTM silicone is injected into each fallopian tube and forms a plug in situ.
  • the MIRENA COBLTM which is a combination product, is a pre-formed tensioned T shaped frame that is placed at the head of the uterine cavity adjacent to the openings to the fallopian tubes. It is impregnated with a hormonal substance, levonorgestrel, which it releases to inhibit monthly growth of the lining of the uterus and normal sperm function.
  • the MIRENA COILTM is reversible and requires replacement after five years.
  • the CONCEPTUS ESSURETM is a metal coil pre-tensioned prior to insertion, which on insertion into the fallopian tube uncoils.
  • the body reaction is an attempt to expel the obstruction which results in stenosis in the tube and leads over time to a permanent block achieved by a combination of the device and fibrotic growths.
  • the CONCEPTUS ESSURETM device being a preformed solid body inserted into the fallopian tubes gives rise to placement issues due to the need to insert a pre-tensioned metal coil at least 3-4 cm into each fallopian tube. Failure rates as high as 15% have been reported.
  • U.S. Patent No. 3,822,702 (Bolduc et al) and U.S. Patent No. Re. 29,207 discloses a fluid dispensing instrument for introducing a tissue adhesive into both canals of the fallopian tubes.
  • the instrument comprises a probe, an expandable balloon assembly to displace the lower portion of the uterine cavity and a dispenser to discharge the tissue adhesive into the uterine cavity above the balloon assembly.
  • the adhesive is forced from the uterine cavity into the canals by the expansion of the balloon and subsequently polymerizes when it reacts with the moisture in the tissue of the fallopian tubes and thereby occludes the canals.
  • U.S. Patent No. 3,875,939 (Bolduc et al) relating to a single stroke dispensing method for use with the above system.
  • U.S. Patent No. 6,096,052 discloses a sterilization device for occluding a reproductive tract or lumen to prevent the passage of reproductive cells through the tract, fallopian tubes, or body lumen.
  • the device comprises a tubular member and a mesh member which is permeable to allow for tissue ingrowth which produces a tissue impregnated mesh occluding the fallopian tubes.
  • U.S. Patent No. 6,432,116 A similar type device is disclosed in U.S. Patent No. 6,432,116 and which can be placed in the fallopian tubes by means of a catheter.
  • Other background information is available in U.S. Patent Nos. 3,887,112 (Bolduc et al); 3,948,259 (Bolduc et al.); 3,972,331 (Bolduc et al.); 4,124,134 (Bolduc et al); 4,109,654 (Bolduc et al.); 4,119,098 (Bolduc et al.); 4,160,446 (Barrington); 4,601,698 (Moulding); 4,509,504 (Brundin); 4,547,188 (Bolduc); 4,245,623 (Erb); 5,469,867 (Schmitt); 5,826,584 (Schmitt); 6,042,590 (Sporrir); 6,066,139 (Ryan); 4,126
  • U.S. Patent No. 5,530,037 discloses a curable cyanoacrylate adhesive composition for medical or veterinary uses which is sterilized in liquid form by gamma irradiation. After irradiation the cyanoacrylate monomer is left in a substantially ungelled state.
  • U.K. Patent Specification No. GB 2 201 685 discloses a composition for occlusion of ducts and cavities of the human body.
  • the composition disclosed incorporates an alpha- cyanoacrylate dimethylsulphoxide, dimethylketone and an iodine-containing radiopaque organic acid, or mixtures of such acids.
  • Examples of the ducts and cavities for occlusion are blood vessels, bronchi, cysts, abscesses and dental canals.
  • WO 92/09651 discloses a polycyanoacrylate foam made by mixing a cyanoacrylate monomer, a liquid foaming agent and a polymerization initiator. The mixture simultaneously polymerises and foams.
  • the foaming agent is usually an organic compound with a boiling point not higher than 100°C, miscible with the monomer but not a solvent for the polymer.
  • the monomer is said to be any 2- cyanoacrylate ester compatible with the composition.
  • WO 00/44287 discloses a composition comprising of a monomer component comprised of an alkyl cyanoacrylate and at least one inhibitor, and a second component comprised of a resultant aggregate structure formed from an alkyl cyanoacrylate monomer, an alkyl esterified fatty acid and an opacificant agent where said composition is useful for filing an existing space, e.g., the lumen of a blood vessel, a space created by a transiently placed external device, e.g., a catheter or like device, a space created by a procedure, e.g., an excision or implantation of an object, e.g., a stent.
  • the composition is also useful for adhering tissue to tissue, or adhering tissue to a device.
  • the composition has the property of polymerizing when it comes in contact with an anionic environment, or when it is deployed in situ in an existing space.
  • WO 00/72821 discloses therapeutic microfoams as a sclerosing agent in blood vessels.
  • the foam comprises polidocanol or sodium tetradecyl sulphate dispensed in a physiological accepted gas and is dispensed from an aerosol.
  • a method and device for producing the foam are also disclosed.
  • Fallopian tubes have a complex anatomy and physiology. They are paired, hollow, seromuscular organs that extend from the superior-lateral aspect of the uterine fundus to the ovaries. The mucosa is thrown into folds that project into the lumen. The height and complexity of the folds vary among the segments of the tube.
  • the mucosa is composed of an epithelial layer which is made up predominately of ciliated and secretory cells. Proportion of cell types vary within different regions of the oviduct. Ciliated cells predominate in the distal oviduct and decrease toward the uterus, whereas the inverse is true of secretory cells. Ciliary beat is toward the uterus. This shows the importance of the formulations ability to flow and fill when selecting the formulation for fallopian tube occlusion.
  • the length of the fallopian tube varies considerably among patients, though in the human female, a minimum length of 8cm and maximum length of 14cm are generally recognized as the upper and lower lengths, with 11 cm being average.
  • the fallopian tube is divided into four sections:
  • the Intramural Its length varies from 0.8cm to 2cm, and has a lumen cross-section which can vary from 0.2mm (hair like) to 2mm.
  • the Isthmus Lumen cross section can vary from 2mm to 3mm at Ampulla junction to 0.2 to 2mm at the Intramural junction. The length of the Isthmus can vary from 2cm to 3cm.
  • the Ampulla This is the longest portion of the fallopian tube, usually two thirds of the total length. The length can vary from 5cm to 8cm.
  • the lumen cross section in this region will vary from 1mm to 10mm.
  • the Infundibulum This section has a short trumpet shape with a maximum cross section of between 5mm to 20mm at its distal end. Its length can vary from 1cm to 1.5cm.
  • the fallopian tube is a well vascularized organ whose primary function is to transport Ovum and Spermatozoa in opposite directions and then transport the developing embryo into the uterus.
  • the Infundibulum and Ampulla with their thin wall, large lumen, and complex densely ciliated mucosal folds. Ciliary activity is of major importance in Ovum transport, with contractual activity a subordinate effector. In contrast, transport through the Isthmus with narrow lumen and sparsely ciliated endosalpinx appears to result primarily from contractile activity.
  • the Ostium is the entrance from the Uterine Cavity to the fallopian tubes Intramural portion and is funnel shaped which aids access.
  • Intramural portion is important to the present invention as its catheter is placed into this portion of the fallopian tube to allow delivery of the occluding compound.
  • the path through the Intramural portion can be (A) Straight, (B) Convex, (C) Tortuous, (D) Angulated.
  • the anatomy of the fallopian tube will significantly affect the performance of any sterilization device both during and after placement. Precise placement and plug formation can be significantly affected by tubal anatomy.
  • the present invention addresses anatomical variations in the selection of values for the volume of cyanoacrylate occluding compound to be delivered, the flow rate and its viscosity and the manner of placement of the delivery component of the present invention.
  • the present invention provides a medical device for delivering an occluding compound comprising a cyanoacrylate, the device comprising a catheter having a distal end, a proximal end and a lumen extending there between and a mixing device for mixing the occluding compound with an additive.
  • the present invention also provides a medical device for delivering an occluding compound, where the cyanoacrylate is selected from methyl cyanoacrylate, ethyl cyanoacrylate, butyl cyanoacrylates, such as n-butyl cyanoacrylate, iso-butyl cyanoacrylate, or sec-butyl cyanoacrylate, octyl cyanoacrylates, and combinations thereof.
  • the present invention also provides a medical device for delivering an occluding compound where the additive comprises a contrast agent to enhance visualization of the occluding compound during delivery, which may be in the form of a solid and is preferably silver.
  • the medical device of the present invention has the advantage that a cyanoacrylate component of the occluding compound is not mixed with a silver component of the occluding compound until just before the occluding compound is delivered to a fallopian tube. This improves the shelf life of the medical device. Therefore the cyanoacrylate component and the silver component of the occluding compound are packaged separately.
  • the present invention further provides an occluding compound for use with the medical device where the occluding compound comprises a cyanoacrylate which is polymerizable into a plug, where the plug causes inflammation of the fallopian tube and stenosis resulting in permanent occlusion of the fallopian tube.
  • the plug may also cause functional destruction of the fallopian tube.
  • the invention is also directed to an occluding compound for use with the medical device, the occluding compound comprising a cyanoacrylate which may be chosen from methyl cyanoacrylate, ethyl cyanoacrylate, butyl cyanoacrylates, such as, n-butyl cyanoacrylates, iso-butyl cyanoacrylates, or sec -butyl cyanoacrylates, octyl cyanoacrylates and other cyanoacrylates known in the art and described in particular in U.S. Patent Nos. 5,530,037 (McDonnell), 5,684,042 (Greff) and 5,665,817 (Greff), the disclosures of each of which being hereby incorporated herein by reference.
  • a cyanoacrylate which may be chosen from methyl cyanoacrylate, ethyl cyanoacrylate, butyl cyanoacrylates, such as, n-butyl cyanoacrylates, is
  • the occluding compound is chosen for its ability to cure into a solid plug and to occlude the fallopian tube.
  • Cyanoacrylates have been identified as a desirable occluding compound, which are used for dispensing into the fallopian tube in the liquid state.
  • the occluding compound comprises a polymerizable cyanoacrylate ester which is a polymerizable monomer or reactive oligomer of a cyanoacrylate ester which, in monomeric form, is represented by the structure of formula (I):
  • R is selected from: alkyl of 1 to 16 carbon atoms, alkenyl of 2 to 10 carbon atoms, cycloalkyl groups of from 5 to 8 carbon atoms, haloalkyl, aryl, aralkyl, allyl, alkoxyalkyl preferably 2-ethoxyethyl or 3-methoxybutyl, and a substituent of the formula:
  • each R' is independently selected from: hydrogen and methyl
  • R" is selected from: alkyl of from 1 to 6 carbon atoms, alkenyl of from 2 to 6 carbon atoms, alkynyl of from 2 to 6 carbon atoms, cycloalkyl of from 3 to 8 carbon atoms, aralkyl selected from benzyl, methylbenzyl, phenylethyl, phenyl, and phenyl substituted with 1 to 3 substituents selected from hydroxy, chloro, bromo, nitro, alkyl of 1 to 4 carbon atoms, and alkoxy of from 1 to 4 carbon atoms. More preferably, in the cyanoacrylate esters of formula I, R is alkyl of from 1 to 10 carbon atoms and still more preferably alkyl of from 4 to 8 carbon atoms.
  • R is an alkyl group of from 1 to 10 carbon atoms including methyl, ethyl, n-propyl, iso-propyl, n-butyl, iso-butyl, sec-butyl, n-pentyl, iso-pentyl, n-hexyl, iso- hexyl, 2-ethylhexyl, n-heptyl, octyl, nonyl, and decyl. More preferably, R is butyl, pentyl or octyl and most preferably, R is n-butyl. Mixtures of such compounds can also be employed.
  • a preferred cyanoacrylate ester for use in the invention is therefore n-butyl 2- cyanoacrylate.
  • the polymerizable cyanoacrylate esters described herein rapidly polymerize in the presence of water moisture or tissue protein.
  • composition of the occluding compound for use with the medical device of the invention comprises a specific polymerization inhibitor and the amount of this inhibitor effectively inhibits both premature and too rapid polymerization of the cyanoacrylate adhesive component of the composition.
  • the composition further comprises a suitable amount of a thickening agent to provide for a compositional viscosity of the occluding compound.
  • the cyanoacrylate of the occluding compound for use with the medical device of the invention is mixed or is mixable with plasticizers, dye or pigments and/or soluble or solid contrast agents and a free radical stabilizer.
  • composition of the occluding compound comprises (a) from about 85 to 90 weight percent of an alkyl cyanoacrylate of formula I above; (b) from about 50 to 500 parts per million of a polymerization inhibitor; (c) from about 10 percent to about 15 percent by weight of a biocompatible thickener; and (d) from about 5,000 to 20,000 parts per million of a free-radical stablizer
  • composition of the occluding compound comprises (a) from about 85 to 90 weight percent of n-butyl cyanoacrylate; (b) from about 50 to 500 parts per million of boron trifluoride (BF 3 ) as a polymerization inhibitor; (c) from about 10 percent to about 15 percent by weight of polymethylmethacrylate (PMMA); and (d) from about 5,000 to 20,000 parts per million of butylated hydroxyanisole (BHA) as a free radical stablizer.
  • boron trifluoride BF 3
  • PMMA polymethylmethacrylate
  • BHA butylated hydroxyanisole
  • n-butyl cyanoacrylate in monomeric form, is represented by the formula:
  • Use of from 50 to 500 ppm of BF 3 as the polymerization inhibitor provides for an alkyl cyanoacrylate composition having a curing time which is neither too fast (i.e. less than about 10 seconds) nor too slow (greater than 60 seconds) so as to interfere with effective application.
  • the occluding compound is preferably stored in a container.
  • the container is manufactured from glass, plastic, or a suitable metal or metal alloy, most preferably the container is manufactured from aluminium.
  • the alkyl cyanoacrylate occluding compound further comprises a sufficient amount of a thickening agent to provide for a viscosity of from about 10 to 5,000 mPas at 25°C.
  • the thickening agent employed is any biocompatible material which increases the viscosity of the alkyl cyanoacrylate composition and includes, by way of example, a partial polymer of the alkyl cyanoacrylate, PMMA or other preformed polymers soluble in the alkyl cyanoacrylate of formula I, a suspending agent such as fumed silica, and the like with PMMA being preferred.
  • the cyanoacrylate may be mixed with dye and/or pigments to enhance its visualization and permit monitoring of the injection while it is taking place to ensure that the sterilization procedure is being carried out properly.
  • a water insoluble contrast agent in the sterilization procedure has the added advantage of providing a facile means to locate the polymeric blockage in the fallopian tubes potentially years after the polymer has been placed there. Ideally this can be achieved by using a radiographic contrast agent by pelvic radiographic examination.
  • the contrast agent is a water insoluble contrast agent which, upon polymerization of the monomer in situ, will form part of the polymer.
  • the contrast agent retained in the polymeric composition can be employed to identify the location of the polymeric blockage in the fallopian tubes.
  • the occluding compound is polymerisable into a plug, where the plug causes inflammation of the fallopian tube and stenosis resulting in permanent occlusion of the fallopian tube.
  • the occluding compound having been subjected to a sterilizing condition selected from the group consisting of gamma irradiation, E-beam, heat and ultrafiltration
  • the kit may be sterilized by exposure to ethylene oxide, well known in the art.
  • the occluding compound has a viscosity range between lOmPas to 5,000mPas at 25°C.
  • the occluding compound is in the form of a liquid.
  • CA in Table 1 is cyanoacrylate of formula I above.
  • the medical device of the present invention includes a mixing device which is used to mix the above cyanoacrylate formulation with silver.
  • the present invention further provides an occluding compound for use with the medical device wherein the occluding compound includes a thickening agent capable of inducing a fibrotic or inflammatory response.
  • the present invention further provides an occluding compound for use with the medical device where the thickening agent is PMMA.
  • the catheter of the medical device may have, on its distal end, a plug for sealing the opening of the fallopian tube prior to delivery of the occluding compound.
  • the catheter may have at its distal end a tapered or beveled distal tip or optionally an oblique beveled distal tip and preferably the distal tip of the catheter has a lubricious coating which is suitable for sterilisation by sterilising means selected from the group comprising gamma radiation, E-beam, heat and ultrafiltration. Most preferably the distal tip of the catheter has a coating of polyethylene (PE), which is suitable for sterilisation using gamma radiation. Thus the choice of coating material is contingent on the sterilisation technique employed.
  • PE polyethylene
  • the catheter may be provided at its distal end with a series of holes about its circumference or a sealed distal tip with a series of holes about its circumference.
  • the catheter can have a detachable distal tip that may be chosen from a biodegradable material, if desired.
  • the catheter has a curved distal end preformed so as to aid location of the catheter in the fallopian tube and the internal lumen of the catheter tapers at various points along its length.
  • the catheter may have an internal mixing chamber connecting a plurality of lumens.
  • the catheter incorporates a screw, which in the preferred option is an Archiamedian screw.
  • one or more lumens may exit through the sidewall at the distal end of the catheter and one or more lumens may exit through the distal tip of the catheter.
  • the catheter may have on its distal end means for retaining an anesthetic material which is used to deliver localized anesthesia to the fallopian tube.
  • preset markers or radio opaque markers may be provided along the catheter to indicate or dictate depth of insertion.
  • the catheter has along at least a portion of its length, an integral stiffening member which may taper from its proximal end to its distal end and have a thickened catheter cross-section with a tapered or bumped extrusion.
  • the stiffening member may be a braid running along the length of the catheter or part thereof or may be a spiral braid along the length of the catheter or part thereof and may comprise a stiffening wire extruded along the length of the catheter or part thereof which can be manually loaded into the catheter prior to insertion into the fallopian tube.
  • the stiffening wire may optionally have on its distal end an anesthetic material for delivering localised anesthesia to the fallopian tube prior to insertion of the catheter.
  • temporary use of a manually loaded stiffening wire during insertion may decrease the preformed curved distal end of the catheter.
  • temporary use of a manually loaded stiffening wire during withdrawal may accentuate the preformed curved distal end of the catheter.
  • the catheter is transparent along all or a portion of its length has a radiopaque or fluoroscopic mark at its distal tip for accessing its positioning and location within the fallopian tube.
  • the catheter may have a hydrophilic coating along its length, or at its distal end to give it non-stick properties within the fallopian tube.
  • the catheter may have various sections of diminishing circumferences along its length from its proximal end towards its distal end and/or may have various sections of diminishing circumferences at its distal end only together with a tapered distal tip that acts as a locator allowing easier insertion of the catheter into the fallopian tube and a means of securing the distal tip of the catheter in the fallopian tube.
  • the catheter has at its proximal end a collapsible longitudinal section.
  • the catheter may comprise a primary catheter and a secondary catheter for concealing the primary catheter during insertion through the cervical canal and uterine cavity or the operating channel of a hysteroscopy sheath, whereby the second catheter protects the primary catheter.
  • the secondary catheter may act as a plug to seal the entrance of the fallopian tube prior to insertion of the primary catheter into the fallopian tube.
  • the secondary catheter may act as a guide to the primary catheter so it can be located at the entrance of the fallopian tube.
  • the secondary catheter may have at its distal end, a raised circumferential surface for sealing the entrance to the fallopian tube.
  • the raised circumferential surface may be in the form of a foam ring or molded stop.
  • the secondary catheter may have an oversized conical distal end tapering down to its distal tip; a plug in the form of an expandable balloon or membrane at its distal end; a suction cup at its distal end; or a convex plate at its distal end to seal the fallopian tube during delivery of the occluding compound the convex plate being adapted to halt and mould any backflow of occluding compound from the fallopian tube with the distal tip of the secondary catheter being used to aid accurate location and depth of insertion of the primary catheter into the fallopian tube prior to and during delivery of an occluding compound.
  • the secondary catheter may act as a means of removing surplus occluding compound from the primary catheter after delivery of the occluding compound into the fallopian tube.
  • the secondary and primary catheters may have corresponding indicators on their external surfaces allowing for controlled insertion and withdrawal through the alignment of the indicators by the operator.
  • the secondary catheter may have a sealed distal tip which is perforated by the primary catheter after the secondary catheter has been located in the fallopian tube.
  • the actuator is located at the proximal end of the catheter.
  • the inventive medical device is provided with an actuator having a handle to enable an operator to hold the actuator together with other instruments or devices.
  • the handle may be provided with a universal applicator so as to adhere to the other instruments or devices and the actuator are rotatable about the handle.
  • the universal applicator is a universal catheter adapter.
  • the actuator may be loaded with an occluding compound or loadable with a vessel containing an occluding compound and is operable to deliver a predetermined amount of occluding compound at a predetermined speed directly into the primary catheter.
  • the actuator is loaded or loadable with vessels containing an occluding compound and associated compounds such as an initiator for mixing with the occluding compound to initiate the polymerization of the occluding compound.
  • an initiator is selected from the group consisting of dimethyl-p-toluidine, dimethylamino- phenyl-ethanol, and combinations thereof.
  • the actuator may also be preloaded or loadable with vessels containing the occluding compound and contrast agents for mixing with the occluding compound to give the mixed occluding compound radiopaque properties.
  • the radiopaque or contrast agent is selected from tantalum, tantalum oxide, lipiodol, silver, gold, tungsten, platinum powders, metrizamide, iopamidol, iothalamate sodium, iodomide sodium, meglumine, or combinations thereof.
  • the actuator may be further preloaded or loadable with vessels containing the occluding compound and a biocompatible dye or pigment.
  • the actuator which may be composed of several separately functioning parts is provided with a chamber into which predetermined amounts of occluding compound and optional additives are separately deliverable for mixing prior to delivery through the actuator into the primary catheter or with a plurality of chambers into which predetermined amounts of occluding compound and associated compounds are separately deliverable from the vessels prior to mixing.
  • the actuator may include or may be provided with a mixing device into which the predetermined amounts of occluding compound and associated compounds are deliverable and mixed prior to their delivery through the actuator into the primary catheter.
  • the actuator includes a stop/start button to control its actions.
  • the actuator may also include a plunger that compresses upon entry of the compound thereby exposing a bleed hole through which air emboli is expelled into an overflow chamber which includes a porous plug at its exit port permitting passage of air but preventing passage of the occluding compound.
  • the actuator includes a leadscrew to advance the plunger in the barrel, where the leadscrew is threaded into the centre axis of a torque output drum which is in turn rotated by a motor spring.
  • the motor spring contains a storage drum and the torque output drum where the motor spring unwinds from the torque output drum to the storage drum upon activation of the stop/start button where the stop/start button engages with the torque output drum.
  • the cyanoacrylate is mixed with silver using a mixing device, which is not part of the actuator.
  • the actuator is connected either directly to the mixing device or alternatively, the actuator is connected to the mixing device by means of an adapter in the form of hollow tube.
  • the mixed compound is then transferred from the mixing device to a chamber in the actuator.
  • the mixing device of the present invention comprises a chamber preloaded with the additive where the additive is expelled from the chamber by the cyanoacrylate component of the occluding compound and the additive returns through the chamber in combination with the cyanoacrylate component of the occluding compound.
  • the mixing device further includes a mixing head including the chamber for storing the additive for mixing with the cyanoacrylate component of the occluding compound, the chamber preferably being in the form of a conduit.
  • the mixing device also includes means for locking the mixing head of the mixing device in a forward position.
  • the cyanoacrylate component of the occluding compound is stored in a container with a seal, the seal on the container is pierced as the mixing device is engaged with the container, prior to cyanoacrylate component being drawn into a mixing chamber in the mixing device and optionally where the mixing device is rotatably engaged with the container or where the container is pierced through with a thrusting motion.
  • the mixing device or actuator includes a device for counting and visually indicating when the correct number of mixing cycles has been completed, the first mixing cycle being completed when the additive in the chamber has been urged out of the chamber by the cyanoacrylate component of the occluding compound passing therethrough.
  • the actuator may utilize a power source which may include springs, propellant gas, CO 2 , manual pressure or any combination thereof as allows for a controlled mixing and delivery at a predetermined speed of the occluding compound.
  • a power source which may include springs, propellant gas, CO 2 , manual pressure or any combination thereof as allows for a controlled mixing and delivery at a predetermined speed of the occluding compound.
  • the mixing device may be used to transfer the occluding compound directly to the catheter.
  • a further aspect of the invention is directed to a transcervical method for delivery of an occluding compound comprising inserting a catheter of the medical device through the operating channel of a hysteroscopic sheath through the vagina, cervical canal and uterine cavity under visualization to access the fallopian tube sealing the entrance to the fallopian tube, and delivering the occluding compound into the fallopian tube.
  • the step of insertion may be aided by a guidewire or by the stiffening member.
  • the step of delivering the occluding compound may involve the withdrawal of the catheter back along a longitudinal section of the fallopian tube to a predetermined point within the fallopian tube; and involves the actuation of the actuator to deliver along a longitudinal section of the fallopian tube a precise and predetermined amount of occluding compound at a calculated and determined speed.
  • occluding compound results in an occlusion along a longitudinal section of the fallopian tube as the occluding compound cures to form a plug resulting in stenosis, fibrosis and deposition of collagen within the fallopian tube.
  • the cured occluding compound results in the formulation of a permanent occlusion along a longitudinal section of the fallopian tube.
  • a still further aspect of the invention provides a method of manufacturing a medical device for delivering an occluding compound within a fallopian tube, the manufacturing method comprising the steps of forming a catheter with a distal end, a proximal end and a lumen extending therebetween and providing a plug on the distal end of the catheter and optionally including the step of providing on the distal end of the catheter means for retaining anesthetic material, providing a mixing device for combining the cyanoacrylate with a radiopaque material and subsequently transferring the mixed compound from the mixing device to the actuator; including the step of providing at the proximal end of the catheter an actuator to deliver an occluding compound through the catheter, and optionally including the step of forming the external shape of the distal end of the catheter to assist placement within the fallopian tube, optionally including the step of coating the distal tip of the catheter with a coating of polyethylene, and optionally incorporating a fluorescent marker on the distal end of the catheter.
  • the manufacturing method may also involve providing the medical device with any one or more of the features identified in this description.
  • the medical device of the invention may be used as a transcervical female sterilization device suitable for out patient clinic or consultancy room based use, requires limited training for the physician and maximizes comfort and convenience for the patient.
  • the medical device may have other medical procedure applications.
  • Occlusion is achieved by a mixed mode of action of the occluding compound which combines adhesion, mechanical blockage, tissue toxicity and fibrosis.
  • Placement, sterilization, and biocompatibility are important considerations for safety and efficacy of the medical device which is the subject of this invention.
  • Mixing, plug formation, adherence and stenosis are important for plug retention, leading to successful sterilization.
  • a general description of some of the embodiments of the device include a mixing device for combining the cyanoacrylate with the radiopaque agent, a primary catheter, which may, in one embodiment, carry on its distal end a plug, the catheter having at its proximal end an ergonomically designed actuator to control the speed of delivery and the amount of a mixed occluding compound delivered.
  • Figure 1 is a cross sectional front view of the uterine cavity and a fallopian tube showing the placement of a catheter into the fallopian tube;
  • Figure 2 is a perspective view of a adhesive capsule for housing and facilitating extraction of cyanoacrylate from a container thereof;
  • Figures 3(a), (b) and (c) are different perspective views of the mixing device
  • Figure 4 is a sectional view of the mixing device
  • Figure 5 is a perspective view of the adhesive capsule engaged with the mixing device
  • Figure 6 is a perspective view of the adhesive capsule engaged with the mixing device shown before the container of cyanoacrylate is punctured and with the adhesive capsule shown in section;
  • Figure 7 shows the same view as in Figure 6 except that Figure 7 shows the configuration after the container of cyanoacrylate has been punctured;
  • Figure 8 is a perspective view of the mixing device filled with cyanoacrylate and detached from the adhesive capsule;
  • Figures 9(a) and 9(b) are two perspective views of the mixing device shown ready to mix the cyanoacrylate with the silver powder which is stored in the mixing head within the barrel of the mixing device;
  • Figures 10(a) and 10(b) are respective perspective views corresponding to those shown in Figures 9(a) and 9(b) with the mixing device being used for mixing the cyanoacrylate and the silver powder;
  • Figures 11(a) and (b) are perspective views corresponding to those shown in Figures 9(a) and (b) and 10(a) and (b) but showing the configuration with the mixing process completed and the cyanoacrylate and silver powder having being homogenously mixed;
  • Figure 12 is a perspective view of the delivery device (actuator).
  • Figure 13 is a side sectional view of Figure 12;
  • Figure 14 shows a top perspective inside view of an actuator showing the detail of the porous plug, extending from the overflow chamber hole;
  • Figure 15 is a partial section through front end of the actuator showing a vent hole in the actuator barrel and the overflow chamber;
  • Figures 16(a) and (b) are two perspective views of the mixing device coupled to an actuator to deliver a predetermined amount of cyanoacrylate to the actuator for subsequent delivery to a fallopian tube;
  • Figure 17 is a perspective view of the actuator connected to an inner catheter
  • the occluding compound is a mixture of two parts: Part A (cyanoacrylate based compound of the occluding compound)
  • This formulation results in a post-irradiation viscosity of between 1500 and 2500mPas when measured at 25°C.
  • the amount of PMMA depends to some extent on the molecular weight of the PMMA, which in this case is between 300,000 and 500,000.
  • Part B silica component of the occluding compound
  • the silver component is silver particles of an average particle size of 4 - 8 microns, which are also sterilised by gamma radiation if desired.
  • the two components are mixed using the mixing device included in the medical device of the present invention, there is an increase in viscosity of the resulting occluding compound.
  • the extent of the increase is dependent upon the amount of silver added.
  • silver is included at between 15 and 17% wt/volume of silver. If 15% of silver is added there is approximately a 12% increase in viscosity. If 17% of silver is added the viscosity increase is in the order of 13.5%.
  • the desired final viscosity is between 1800 and 2800mPas.
  • the formulation given here in Example 1 results in a viscosity nearer the 1800 mPas end of the range as this will help prolong the shelf life of the formulation under normal storage conditions.
  • sterilization refers to a process for making a female human or an animal subject unable to produce offspring.
  • sterilization is carried out by delivering an occluding compound into the fallopian tube of the female human or animal subject.
  • the occluding compound then fills, plugs or causes closure of the fallopian tube so that eggs cease to pass therethrough.
  • polymerizable cyanoacrylate esters refers to polymerizable formulations comprising of cyanoacrylate monomers or polymerizable oligomers which, in their monomeric form, are preferably compounds represented by formula I as described hereinbelow.
  • contrast agent refers to a biocompatible (non-toxic) radiopaque material capable of being monitored during injection into a mammalian subject by, for example, radiography or after delivery by x-ray.
  • cyanoacrylate or CA in the following description of the medical device refer to the cyanoacrylate based component of the occluding compound of the formulation referred to above in Table 1.
  • the female reproductive organs which includes a uterus 2 joined to a pair of fallopian tubes 3.
  • the lower section of the uterus 2 includes the vaginal canal 4, cervix 5 and cervical canal 6.
  • the uterus 2 is hollow and thick walled creating the uterine cavity 7. It varies in size, shape and wall thickness.
  • the fallopian tubes 3 have openings into the upper end of the uterus 2 known as the ostium 8.
  • the fallopian tubes 3 vary in size from female to female, varying between 8cm and 14cm long and extending from the upper end of the uterus 2 to the ovaries 9.
  • the fallopian tube 3 is divided into four sections, namely the intramural 10, isthmus 11, ampulla 12 and infundibulum 19 sections.
  • the medical device of the present invention includes an inner catheter 16 which is shown passing through an outer catheter 17 and a hysteroscopic sheath 18.
  • the inner catheter 16 is sufficiently long to pass through the vaginal cavity 4 and cervical canal 6 through the uterine cavity 7 and into the fallopian tubes 3.
  • the medical device of the invention includes the following components: an adhesive capsule indicated generally by reference number 100; a mixing device indicated generally by reference numeral 200; a first actuator indicated generally by reference numeral 300 and a second actuator (300) which is constructionally and operationally the same as the first actuator (300).
  • the medical device of the present invention includes two actuators, a first of which is shown in the drawings and indicated generally by reference numeral 300 and a second identical actuator.
  • the first actuator is used for delivering the occluding compound to the first fallopian tube and the second actuator is used for delivering occluding compound to the second fallopian tube.
  • the adhesive capsule 100 includes gripping fingers 101 for holding an aluminium container 105 of cyanoacrylate.
  • the adhesive capsule 100 also includes a mating port 110 adapted for detachably receiving the mixing device 200.
  • the mating port 110 is adapted so as to engage the connector port 202 on the mixing device 200.
  • the mixing device 200 includes a plunger 201 and a mixing device head 210.
  • the mixing device 200 also includes a connector port 202 distal from the plunger 201.
  • the connector port 202 engages with the adhesive capsule 100 mating port 110.
  • the connector port 202 has a tapered spout for puncturing a seal 111 on the container (tube) 105 of cyanoacrylate .
  • the mixing device 200 also includes a mixing device barrel 205.
  • the mixing device 200 includes handle 206 against which a user may press his fingers to assist gripping the mixing device 200.
  • a locking tab 207 is also included in the mixing device 200 to prevent unintentional movement of the plunger 201.
  • the mixing device 200 also includes a sealing cap 220, which may be secured on the connector port 202 of the mixing device 200.
  • the mixing device head 210 includes a powder chamber 211 for containing silver.
  • a compression spring 215 in the mixing device 200 causes the mixing device head 210 to return to its start position after it has being pushed forward.
  • the actuator 300 includes an On/Off button 301, an actuator barrel 302, and a actuator connector port 305.
  • the adapter 600 is used for coupling the actuator 300 to the mixer device 200.
  • the motor spring 315 is stored on the torque output drum 308 within the actuator 300.
  • the pre-tensioned spring 315 unwinds from the torque output drum 308 onto the storage drum 309.
  • a leadscrew 312 having a plunger seal 313 attached to a first end is engaged with the threaded center of the torque output drum 308 at the mid-section of the leadscrew. Where the mid-section is defined as being intermediate a first and second end of the leadscrew and where the first and second end of the leadscrew are positioned remote from each other.
  • the plunger seal 313 pushes the occluding compound out of the actuator barrel 302.
  • the stop tab 307 controlled by the On/Off switch 301 engages with the vanes 306 on the torque output drum 308 and prevents the motor spring 315 from running.
  • the actuator 300 also includes an overflow chamber 310 and a porous plug 314.
  • the medical device of the present invention may also include a catheter connection 400 for selectively coupling to a catheter 16 to the actuator 300.
  • the medical device of the present invention includes a container 105 of cyanoacrylate occluding compound of the formulation described above.
  • the container 105 is held rigidly within the adhesive capsule 100.
  • the first step in the procedure is to transfer the cyanoacrylate occluding compound from the adhesive capsule 100 to the mixing device 200.
  • the connector port 202 of the mixing device 200 is inserted into the mating port 110.
  • the mixing device 200 is rotated clockwise to mechanically engage both devices.
  • a transfer port 203 engages with a piercing collar (not shown) and is advanced against the container seal 111 until it punctures through the container seal 111 thereby opening a fluid path between the container 105 and the barrel 205 of the mixing device 200.
  • the locking tab 207 is removed from the mixing device 200 and the plunger 201 is pulled back to draw 6ml of cyanoacrylate occluding compound into the mixing device barrel 205.
  • 4ml of cyanoacrylate occluding compound is dispensed back into the adhesive capsule 100 and as the assembly is held vertical during this process, air bubbles will advance into the container 105.
  • the adhesive capsule 100 is then disconnected and discarded.
  • a sealing cap 220 is placed on the connector port 202 of the mixing device 200.
  • the mixing device 200 is used to combine and mix the cyanoacrylate occluding compound with the silver powder.
  • the silver powder is stored in the mixing device head 210 within the barrel 205 of the mixing device. Once the cyanoacrylate occluding compound is within the barrel 205 and sealing cap 220 is attached the process of mixing can begin.
  • the mixing device head 210 is engaged by rotating the plunger 201 into the mixing position. Once the plunger 201 is aligned with the slot 208, the plunger is then pushed forward to the end of the slot 208. Pushing on the plunger 201 advances the mixer head to the distal end of the mixing device barrel 205.
  • the mixing head 210 When advanced, the mixing head 210 is pushed into the cyanoacrylate occluding compound causing the cyanoacrylate occluding compound to push the silver powder out of its powder chamber 211 in the mixing head 210 thus forming a conduit so that the cyanoacrylate occluding compound can pass from one side of the mixing head 210 to the other side thereof.
  • the mixing head 210 reaches the distal end of the barrel 205, the plunger 201 is released and the compression spring 215 acts to return the plunger 201 and mixing device head 210 to its start position. As the mixing device head 210 is pushed forward it rotates through 90 degrees.
  • the mixing device head 210 returns through the cyanoacrylate occluding compound and silver, the mixture must pass through the powder chamber 211 in the mixing head 210 causing it to mix further.
  • the forward and back movement of the plunger 201 and head 210 occurs 20 times.
  • the reciprocating motion, in combination with the rotary motion causes the occluding compound to be mixed effectively.
  • An index counter 221 within the mixing device body signals the 20 th cycle by releasing a green indicator. This is the signal to the user to stop mixing.
  • the next step in the process involves the transfer of the cyanoacrylate occluding compound from the mixing device 200 to each of the actuators 300.
  • Two identical actuators 300 are included in the medical device of the present invention, i.e. one actuator 300 for delivery of occluding compound to each fallopian tube.
  • the sealing cap 220 is removed from the connector port 202 of the mixing device 200 and the transfer adapter 600 is connected to the transfer port 203.
  • the actuator connector port 305 on the actuator 300 is connected to the other end of the adapter 600.
  • the connector port 202 of the mixing device 200 may be connected directly to the actuator connector port 305 of the actuator 300.
  • the mixing device plunger 201 is rotated to the dispense position and half of the contents (1ml) within the mixing device barrel 205 are injected through the transfer adapter 600 and into the barrel 302 of the actuator 300.
  • the plunger seal 313 will compress to expose a vent hole 311 in the barrel 302 ( Figure 15) through which the air and some adhesive will exit into an overflow chamber 310.
  • the porous plug will allow air to pass through it but will not allow the occluding compound to pass.
  • the fluid will stop entering the actuator barrel 302 once it and the overflow chamber 310 is full of occluding compound.
  • the actuator 300 is disconnected from the mixing device 200 and the actuator is attached to the catheter connection 400.
  • the first step in the procedure involves placement of the hysteroscopy sheath 18 and hysteroscope transvaginally. Once in position, a camera is attached to the hysteroscope and the clinician has a clear view of the uterine cavity. Once the fallopian tubes ostia are visualized by the clinician, the outer catheter 17 is placed into the operating channel of the hysteroscopy sheath with the aid of a stiffening wire (not shown). The stiffening wire is then removed from the outer catheter 18. The inner catheter 16 with an actuator 300 connected and with a guidewire (not shown) pre-loaded is positioned within the outer catheter 17. The distal inner catheter tip is then guided into the fallopian tube to a depth of between 5 and 10mm.
  • the clinician will confirm visually that the distal tip of the catheter is in position in the fallopian tube before pushing down and forward on the actuator On/Off button 301 causing the motor spring to actuate and advance the plunger 201 into the barrel 302.
  • the occluding compound will advance through the catheter 16 and into the fallopian tube.
  • the actuator button 301 is pushed back to the "Off' position where it engages with the vanes 306 of the torque output drum and stops the motor spring.
  • the inner catheter 16 is withdrawn back through the outer catheter and discarded along with the first actuator 300.
  • a second inner catheter 16 with pre-loaded guidewire is connected to a second actuator 300 and is advanced into position through the outer catheter 17 for delivery of occluding compound to the second fallopian tube.
  • the sheath 18 is removed from the patient and any excess occluding compound is removed from the distal tip of both catheters before they are withdrawn through the operating channel of the sheath 18. This is to ensure that no adhesive residues are left within the channel.
  • Precise delivery and plug formation and adherence are dependent on a number of variables which the present invention addresses including the anatomy and physiology of fallopian tubes, the occluding compound and the plug shape.
  • Additives for the occluding compound can include the following:
  • biocompatible plasticizer refers to any material which is soluble or dispersible in the cyanoacrylate ester of formula I and which increases the flexibility of the resulting polymer plug and which is compatible with the human and animal body.
  • Suitable plasticizers are well known in the art and include those disclosed in U.S. Patent Nos. 2,784,127 and 4,444,933, the disclosures of both of which are incorporated herein by reference.
  • Specific plasticizers include, by way of example only, acetyl tri-n-butyl citrate, n-butylryl tri-n-hexyl citrate, benzoate esters of di-and polyhydroxy branched aliphatic compounds, tri(p-cresyl) phosphate, and the like.
  • the particular plasticizer employed is not critical provided that it does not result in irritation of the human or animal body. Thickening Agent
  • composition of the occluding compound of the present invention can optionally contain a sufficient amount of a thickening agent to provide for a viscosity of from about 10 to 5,000 cps at 25°C.
  • the thickening agent employed is any biocompatible material which increases the viscosity of the alkyl cyanoacrylate composition and includes, by way of example, a partial polymer of the alkyl cyanoacrylate, PMMA or other preformed polymers soluble in the alkyl cyanoacrylate, a suspending agent such as formed silica and the like with PMMA being preferred.
  • Thickening agents are deemed to be suitable if they are both soluble in the alkyl cyanoacrylate composition and are biocompatible.
  • the particular thickening agent employed to enhance the viscosity of the composition may be chosen by a person skilled in the art.
  • Preferred thickening agents include PMMA, partially polymerized cyanoacrylate adhesives as disclosed in U.S. Patent Nos. 3,654,239 and 4,038,345, each of which are incorporated herein by reference.
  • the thickening agent may also have an additional function as a fibrotic agent.
  • the contrast agent used in conjunction with the composition of the occluding compound can be either water soluble or water insoluble.
  • water soluble contrast agents include metrizamide, iopamidol, iothalamate sodium, iodomide sodium, and meglumine.
  • solid water insoluble contrast agents include tantalum, lipiodol, tantalum oxide, and barium sulfate, each of which is commercially available in the proper form for in vivo use including a particle size of about 10 ⁇ m or less.
  • Other water insoluble contrast agents include silver, gold, tungsten, and platinum powders.
  • the contrast agent is water insoluble (i.e., has a water solubility of less than 0.01 mg/ml at 20°C) and most preferably the contrast agent is silver.
  • the occluding compound is liquid (as in the case of a cyanoacrylate)
  • the use of a biocompatible dye or pigment to enhance visualization of the occluding compound during delivery is advantageous.
  • the contrast agent used for example, silver, may impart colour to the occluding compound.
  • Cyanoacrylate adhesives are stabilised against anionic and free-radical polymerisation in order to ensure shelf life stability.
  • U.S. Patent No. 5,530,037 discloses a method of making a sterilized cyanoacrylate composition.
  • the composition comprises a combination of an anionic stabilizer and a free-radical stabilizer in amounts effective to stabilize the composition during irradiation and to stabilize the sterilized composition during irradiation and storage prior to cure, where the free-radical stabilizer is a phenolic antioxidant.
  • compositions of the occluding compound can be prepared by adding sufficient amounts of the silver contrast agent to the cyanoacrylate to achieve an effective concentration.
  • the cyanoacrylate occluding compound should comprise from about 10 to about 40 weight percent of the silver contrast agent and most preferably about 15 weight percent. .
  • agitation may be employed to effect homogeneity of the resulting suspension.
  • the silver particles can be up to 50 microns in particle size.
  • the particle size of the silver contrast agent is preferably maintained at about 10 ⁇ m or less and more preferably at from about 4 to about 8 ⁇ m which provides an average particle size of approximately 6 ⁇ m.
  • the methods of this invention facilitate female sterilization because the presence of the contrast agent and dyes in the composition permits monitoring of the delivery of the biocompatible polymer while it is taking place and after it is delivered. In this way, one can ensure that the biocompatible polymer is being delivered to the fallopian tubes as well as determine whether the size of the polymer precipitate thus-formed will be sufficient to block the passage of eggs.
  • the delivered occluding compound occludes the fallopian tube lumen and remains in place.
  • the fallopian tube lumen is stretched by the occluding plug to anchor the plug and to seal off the fallopian tube.
  • the plug delivered by the present invention is flexible; thus the present invention takes into account that tubal diameter changes with hormonal phases, and thus the plug distends outwards towards the epithelial lining for complete occlusion.

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Abstract

L'invention concerne un dispositif transcervical et un procédé associé, lesquels permettent d'administrer un composé occlusif destiné à sceller les trompes de Fallope en vision directe, ce dispositif comprenant un cathéter primaire porté éventuellement dans un second cathéter. Le cathéter primaire porte à son extrémité distale un bouchon destiné à sceller l'entrée de la trompe de Fallope en préparation à l'administration d'un composé occlusif, ce cathéter primaire possédant à son extrémité proximale un dispositif d'actionnement destiné à mélanger et à commander la vitesse d'administration d'une quantité requise d'un composé occlusif mélangé.
PCT/IE2004/000098 2003-07-18 2004-07-19 Dispositif et procede pour l'occlusion des trompes de fallope WO2005006991A2 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
EP03394065.1 2003-07-18
EP03394065 2003-07-18
US50614903P 2003-09-29 2003-09-29
US60/506,149 2003-09-29

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Cited By (9)

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WO2007133222A1 (fr) 2006-05-11 2007-11-22 Ams Research Corporation Systèmes pour boucher l'appareil génital faisant office de contraception
WO2009140686A3 (fr) * 2008-05-16 2010-07-01 Conceptus, Inc. Dispositif et système d'occlusion pour obturer un passage corporel de la reproduction
US8100129B2 (en) 2007-08-28 2012-01-24 Conceptus, Inc. Methods and devices for occluding an ovarian pathway
KR20150008139A (ko) * 2012-04-24 2015-01-21 유로진 비.브이. 나팔관에 폐색 화합물을 투여하기 위한 애플리케이터
CN109200446A (zh) * 2018-09-14 2019-01-15 温州市中心医院 一种新型腔镜用药物注射装置
US10202585B2 (en) 2009-12-22 2019-02-12 Lifebond Ltd Modification of enzymatic crosslinkers for controlling properties of crosslinked matrices
CN116173383A (zh) * 2023-02-10 2023-05-30 浙江桐轩医疗科技有限公司 一种生物相容性强的输卵管用球囊导管
US11998654B2 (en) 2018-07-12 2024-06-04 Bard Shannon Limited Securing implants and medical devices
US12194189B2 (en) * 2018-09-17 2025-01-14 Chemence Medical, Inc. Stable compositions composed of a radiopaque agent and cyanoacrylate monomer and applications thereof

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US4245623A (en) * 1978-06-06 1981-01-20 Erb Robert A Method and apparatus for the hysteroscopic non-surgical sterilization of females
WO1981000701A1 (fr) * 1979-09-12 1981-03-19 Population Res Inc Sterilisation de la femme
US4574097A (en) * 1984-08-10 1986-03-04 Isopedix Corporation Reinforced thixotropic gel composition
TW359683B (en) * 1993-12-23 1999-06-01 Loctite Ireland Ltd Sterilized cyanoacrylate adhesive composition, and a method of making such composition
US6476069B2 (en) * 1997-09-11 2002-11-05 Provasis Therapeutics Inc. Compositions for creating embolic agents and uses thereof
US6001345A (en) * 1997-11-03 1999-12-14 Medlogic Global Corporation Application of cyanoacrylate/anti-microbial compositions to the peri-wound or peri-mucosal area

Cited By (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8550085B2 (en) 2006-05-11 2013-10-08 Conceptus, Inc. Methods and apparatus for occluding reproductive tracts to effect contraception
WO2007133222A1 (fr) 2006-05-11 2007-11-22 Ams Research Corporation Systèmes pour boucher l'appareil génital faisant office de contraception
US7975697B2 (en) 2006-05-11 2011-07-12 Conceptus, Inc. Methods and apparatus for occluding reproductive tracts to effect contraception
US8726905B2 (en) 2007-08-28 2014-05-20 Bayer Essure Inc. Methods and devices for occluding an ovarian pathway
US8100129B2 (en) 2007-08-28 2012-01-24 Conceptus, Inc. Methods and devices for occluding an ovarian pathway
US8689792B2 (en) 2008-05-16 2014-04-08 Bayer Essure Inc. Occlusion device and system for occluding a reproductive body lumen
WO2009140686A3 (fr) * 2008-05-16 2010-07-01 Conceptus, Inc. Dispositif et système d'occlusion pour obturer un passage corporel de la reproduction
US10202585B2 (en) 2009-12-22 2019-02-12 Lifebond Ltd Modification of enzymatic crosslinkers for controlling properties of crosslinked matrices
KR20150008139A (ko) * 2012-04-24 2015-01-21 유로진 비.브이. 나팔관에 폐색 화합물을 투여하기 위한 애플리케이터
KR102086991B1 (ko) * 2012-04-24 2020-05-28 유로진 비.브이. 나팔관에 폐색 화합물을 투여하기 위한 애플리케이터
US11998654B2 (en) 2018-07-12 2024-06-04 Bard Shannon Limited Securing implants and medical devices
CN109200446A (zh) * 2018-09-14 2019-01-15 温州市中心医院 一种新型腔镜用药物注射装置
CN109200446B (zh) * 2018-09-14 2024-05-14 温州市中心医院 一种腔镜用药物注射装置
US12194189B2 (en) * 2018-09-17 2025-01-14 Chemence Medical, Inc. Stable compositions composed of a radiopaque agent and cyanoacrylate monomer and applications thereof
CN116173383A (zh) * 2023-02-10 2023-05-30 浙江桐轩医疗科技有限公司 一种生物相容性强的输卵管用球囊导管

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