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WO1998031308A1 - Microspirale contraceptive transcervicale en platine - Google Patents

Microspirale contraceptive transcervicale en platine Download PDF

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Publication number
WO1998031308A1
WO1998031308A1 PCT/US1998/001146 US9801146W WO9831308A1 WO 1998031308 A1 WO1998031308 A1 WO 1998031308A1 US 9801146 W US9801146 W US 9801146W WO 9831308 A1 WO9831308 A1 WO 9831308A1
Authority
WO
WIPO (PCT)
Prior art keywords
microcoil
contraceptive
pigtail
proximal
distal
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/US1998/001146
Other languages
English (en)
Inventor
John Cardella
Jay Post
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Penn State Research Foundation
Original Assignee
Penn State Research Foundation
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 Penn State Research Foundation filed Critical Penn State Research Foundation
Priority to AU59267/98A priority Critical patent/AU5926798A/en
Publication of WO1998031308A1 publication Critical patent/WO1998031308A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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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
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/1214—Coils or wires
    • A61B17/12145—Coils or wires having a pre-set deployed three-dimensional shape
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/1214—Coils or wires
    • A61B17/1215—Coils or wires comprising additional materials, e.g. thrombogenic, having filaments, having fibers, being coated
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires

Definitions

  • Hysteroscopic sterilization techniques are performed with either general or paracervical local anesthesia.
  • the cervic and uterine cavity are sounded and, when necessary, endocervical dilatation is performed.
  • a hysteroscope is then introduced and the uterine cavity is distended with either high molecular weight dextran, dextrose in water, or carbon dioxide gas.
  • Tubal sterilization can then be accomplished via a microcatheter introduced coaxially through the hysteroscope.
  • Uterine perforation is a known complication.
  • Nonsurgical fallopian tube recanalization for treatment of infertility Radiology 1990; 174:571-574.
  • the transcatheter fluoroscopically guided interventional radiologic techniques can be used for fallopian tube occlusion (Maubon A., Selective tubal sterilization in rabbits: experience with a hydrogel combined with a sclerosing agent. Radiology 1994; 193:721-723; Berkey G. et al., Sterilization with Methyl Cyanoacrylate-induced Fallopian Tube Occlusion from a Nonsurgical Transvaginal Approach in Rabbits.
  • Occluding agents that have been tested include hydrogel combined with sclerosing agent (Maubon et al.), methyl cyanoacrylate (Berkey et al.), stainless steel microspindle (Schmitz-Rode, T., et al.), and stainless steel coil (Ross et al.).
  • Berkey et. al. used intratubal methyl cyanoacrylate in an attempt to achieve permanent sterilization in rabbits. They found a 100 % nonpregnancy rate in eleven rabbits that underwent six months of mating trials. Histologic examination revealed tubal wall fibrosis with varying degrees of occlusion.
  • Schmitz-Rode et. al. deployed a tubular metal mesh microspindle in rabbit fallopian tubes for permanent sterilization. Successful contraception was achieved in nine rabbits that had 25 gestations on the nonspindle side and no gestations on the spindle side.
  • One rabbit with a relatively short spindle (9 mm) had pregnancies on both the spindle and nonspindle sides. The spindles were found to be firmly embedded in the tubal wall without evidence of inflammation.
  • Ross et. al. used a 3.9 cm long, 0.021" diameter stainless steel spring coil placed in a uterotubal location in rabbits in an attempt to develop an efficacious and reversible method of sterilization.
  • the coil was placed with one 3 mm radius loop in the fallopian tube and two similar loops in the uterus. Dislodgement of the coils occurred in 11 of 32 rabbits (34%). When the coil remained in position, it failed to prevent pregnancy in 3 of 19 (16%) rabbits.
  • Ross et. al. speculated that a uterotubal coil might have the high degree of efficacy and the reversibility of the intrauterine device (IUD), but without its associated infectious complications. However, their study showed a contraception failure rate of 44% that was primarily related to coil dislodgement from the fallopian tube.
  • Contraceptive transcervical fallopian tube occlusion devices are described by international application PCT/US96/07483 ("the 7483 application") published on December 19, 1996 as WO 96/400023.
  • the disclosed devices are formed at least in part from copper or a copper alloy.
  • U.S. Patent No. 5,601,600 describes endoluminal coil delivery systems, endoluminal coils, and methods for positioning a coil within a body lumen such as the lumen of the fallopian tube.
  • the patent discloses an improved endoluminal coil comprising a fitting disposed on the coil.
  • Vaso- occlusion devices are surgical implements or implants that are placed within the vasculature of the human body, typically via a catheter, either to block the flow of blood through a vessel making up that portion of the vasculature through the formation of an embolus or to form such an embolus within an aneurysm stemming from the vessel.
  • One widely used vaso-occlusive device is a helical wire coil having windings which may be dimensioned to engage the walls of the vessels.
  • Other less stiff helically coiled devices have been described, as well as those involving woven braids. For instance, U.S. Pat. No.
  • Vaso-occlusive coils having attached fibrous elements in a variety of secondary shapes are shown in U.S. Pat. No. 5,304, 194, to Chee et al.
  • Chee et al. describes a helically wound device having a secondary shape in which the fibrous elements extend in a sinusoidal fashion down the length of the coil.
  • These coils as with Ritchart et al., are produced in such a way that they will pass through the lumen of a catheter in a generally straight configuration and, when released from the catheter, form a relaxed or folded shape in the lumen or cavity chosen within the human body.
  • the fibrous elements shown in Chee et al. enhance the ability of the coil to fill space within the vasculature and to facilitate formation of embolus and subsequent allied tissue.
  • a three dimensional in-filling vaso-occlusive coil is described in U.S. Pat. No. 5,624,461 to Mariant.
  • the device is a complex, helically wound coil comprised of a primary helically wound coil which is then wound into a specific secondary shape.
  • the final shape upon deployment is in the approximate shape of an anatomical cavity.
  • the device Upon deployment, the device first fills the periphery of the cavity and then continues to in-fill the center. Fibers may be introduced onto the device and affixed to the pre-formed linear member.
  • the contraceptive microcoil comprises a resilient primary coil free from any fittings made of a biocompatible material; and a secondary shape including a distal pigtal having at least one turn, a proximal pigtail having at least one turn, and a substantially straight intervening segment delimited by the distal pigtail and the proximal pigtail.
  • Fig. 1 is a drawing of one embodiment of the contraceptive microcoil
  • Fig. 2 is a drawing of another embodiment of the contraceptive microcoil
  • Fig. 3 is a photograph of an embodiment of the contraceptive microcoil comprising polyester fibers and a 3 mm pigtail at each end;
  • Fig. 4 is a typical normal left hysterosalpingogram of a rabbit, showing vagina (large straight arrows), uterine horn (small straight arrows), fallopian tube (curved arrows), and free spillage of contrast into the peritoneal cavity (outline arrow);
  • Fig. 5 is a hysterogram obtained after placement of a contraceptive microcoil in a rabbit, showing the air filled vagina (large straight arrow), uterine horn (small straight arrow), and 7 cm microcoil (curved arrows) positioned in uterine horn and right fallopian tube;
  • Fig. 6 is a radiograph of the rabbit of Fig. 5, showing the empty uterine horn on the microcoil side (short arrow), the uterotubal junction (long arrow), and eight gestational sacs in the control uterine horn (curved arrows);
  • Fig. 7 is a photomicrograph of a fallopian tube after microcoil removal, showing dilation of the lumen (L) by the presence of the microcoil, loss of most of the mucosal epithelium (arrow), increased fibrous connective tissue (F) in the lamina intestinal and occasional inflammatory cells (hematoxylin and eosin stain, photographed at 5 OX magnification); and
  • Fig. 8 is a photomicrograph of a uterine horn after microcoil removal, showing circular defect (D) associated with the presence of the microcoil characterized by a focal loss of adjacent mucosal epithelium, and clusters of sloughed epithelial cells and inflammatory cells present between papillary proliferative structures (arrow) of the endometrial epithelial cells, (hematoxylin and eosin stain, photographed at 3 OX magnification).
  • D circular defect
  • arrow papillary proliferative structures
  • the preferred embodiments of the invention are contraceptive microcoils comprising a resilient primary coil having distal and proximal ends.
  • the resilient primary coil is formed into a secondary shape which is assumed when the contraceptive microcoils is in a relaxed state. Fibrous materials may be woven into, wrapped around, or tied to the primary coil or, alternatively, attached to the primary coil using a suitable adhesive.
  • the contraceptive microcoil is made of a radiopaque, biocompatible material.
  • the biocompatible material is chosen from the group consisting of platinum, gold, iridium, tungsten, stainless steel, nickel, titanium and alloys thereof.
  • Preferred alloys are nickel titanium shape memory alloys (nitinol).
  • the contraceptive microcoil is made of platinum.
  • Bioactive substances, such as copper and copper alloys, are not suitable for the practice of the present invention.
  • the resilient primary coil is formed by a wire wound in a helix or by several wires or fibers braided into a hollow tube.
  • the resilient primary coil is formed from wire ranging from about 0.010 inch (0.254 mm) to about 0.038 inch (0.965 mm) in diameter, more preferably ranging from about 0.010 inch (0.254 mm) to about 0.025 inch (0.635 mm) in diameter.
  • the resilient primary coil is formed from platinum wire 0.018 inch (0.457 mm) in diameter.
  • the primary coil is free from any fittings, such as endcaps or tips, attached to or disposed on the resilient primary coil.
  • the outer diameter of the primary coil, including any fibers, is chosen to be less than the inner diameter of the delivery catheter.
  • a preferred outer diameter for the primary coil, including fibers, is from about 0.018 inch (0.457 mm) to about 0.032 inch (0.813 mm).
  • the resilient primary coil is formed into a secondary shape comprising at least one distal pigtail and at least one proximal pigtail Pigtails are defined herein as loosely cylindrical stacks of secondary coils comprising multiple turns Such multiple turns of secondary coils are designed to provide solid and robust anchoring of the contraceptive microcoil within the fallopian tube. It should be understood, however, that, due to the interaction of the secondary shape of the contraceptive microcoil and the inner surface of the fallopian tube, the secondary shape in situ may differ from the secondary shape that the contraceptive microcoil would assume in its unrestrained relaxed state.
  • the proximal pigtail provides a convenient attachment site that can be snared and gently pulled when retrieving the contraceptive microcoil.
  • the tension applied when gently pulling the proximal pigtail of the contraceptive microcoil acts to straighten the contraceptive microcoil, reducing the volume of the secondary shape and thereby facilitating the removal of the contraceptive microcoil from the fallopian tube.
  • each of the distal and proximal pigtails comprise loosely cylindrical stacks of from one to ten turns. More preferably, the distal and proximal pigtails comprise stacks of from one to five turns. In one preferred embodiment, the distal and proximal pigtails have different numbers of turns.
  • the contraceptive microcoil can be temporarily constrained in a straightened configuration and placed into a suitable delivery catheter having distal and proximal openings.
  • the delivery catheter containing the constrained contraceptive microcoil can be situated with the distal opening of the catheter in the lumen or body cavity to be occluded.
  • the contraceptive microcoil is then pushed through the catheter, and, upon ejection from the catheter, assumes its secondary shape in its relaxed state when unconstrained by the delivery catheter.
  • a first embodiment of the present contraceptive microcoil 10 is formed from a resilient primary coil 12.
  • the resilient primary coil 12 The resilient primary coil
  • the contraceptive microcoil 10 has a distal end 14 and a proximal end 16.
  • "Proximal” and “distal” are defined herein with respect to the contraceptive microcoil's placement in the fallopian tube, and thus “distal” is defined as “nearer the ovary” and “proximal” is defined as “nearer, the uterus.”
  • the resilient primary coil lacks any fittings attached to or disposed on the resilient primary coil.
  • the distal end 14 and the proximal end 16 are free from additional fittings such as endcaps or tips.
  • the contraceptive microcoil is formed into a secondary shape that the contraceptive microcoil tends to assume in the relaxed state when freed from stress or constraint.
  • the contraceptive microcoil When deployed within the fallopian tube, the contraceptive microcoil assumes its secondary shape, but since the coil is limited by its contacts made with the internal surface of the fallopian tube, the contraceptive microcoil may not completely assume its relaxed state.
  • the structures of the secondary shape such as the distal and proximal pigtails contact, at least in part, the internal surface of the fallopian tube, thereby securing the contraceptive microcoil within the fallopian tube.
  • characteristics of the secondary shape e.g., the diameter of the turns of the distal and proximal pigtails or the number of turns of the when placed in the fallopian tube may vary from the relaxed state depending on the placement of the contraceptive microcoil and the dimensions of the particular fallopian tube.
  • the structures of the secondary shape of the contraceptive microcoil comprise a distal pigtail comprising at least one turn 18 and a proximal pigtail comprising at least one turn 20.
  • the proximal and distal pigtails each comprise stacks of about one to about ten turns. In one preferred embodiment, the distal and proximal pigtails comprise stacks of about one to about five turns. In another preferred embodiment, the distal and proximal pigtails comprise stacks of about two to about six turns. In one preferred embodiment, the distal and proximal pigtails have different numbers of turns.
  • the outer diameter 22 of the turn of the distal pigtail and the outer diameter 24 of the turn of the proximal pigtail in the unconstrained relaxed state range from about 1 mm to about 10 mm, preferably from about 1.5 mm to about 7.5 mm, more preferably from about 1.5 mm to about 5 mm. In one preferred embodiment, the outer diameter 22 of the turn of the distal pigtail and the outer diameter 24 of the turn of the proximal pigtail are both about 3 mm. In other embodiments, the outer diameter 22 of the turn of the distal pigtail may be different from that of the outer diameter 24 of the turn of the proximal pigtail. In one embodiment the outer diameter 22 of the turn of the distal pigtail is smaller than the outer diameter 24 of the turn of the proximal pigtail.
  • the outer diameters of the turns within a pigtail can be different.
  • the outer diameters of the turns may decrease progressively from turn to turn from the end of the primary coil to the nearer end of the intervening segment, approximating a funnel shape.
  • the outer diameters of the turns with each pigtail are within ⁇ 50% of the average outer diameter, preferrably within ⁇ 20% of the average diameter.
  • the distal end and proximal end may terminate within the boundary of the turn of the respective pigtail, as shown in Fig. 1 for the proximal end 16. Alternatively, either or both ends may extend beyond the boundary of the turn of the respective pigtail, as shown in Fig. 1 for the distal end 14.
  • the intervening segment 26 is delimited by the distal pigtail and the proximal pigtail.
  • the intervening segment 26 is substantially straight in the relaxed state of the contraceptive microcoil, that is, the radius of curvature of intervening segment 26 is greater than the length of intervening segment 26.
  • the intervening segment 26 is about one cm to about ten cm in length.
  • Preferably the intervening segment is about three to about seven cm in length.
  • Fibers 28 are optionally disposed on the resilient primary coil along the length of the resilient primary coil. For clarity only a few fibers are illustrated at one position in Fig. 1. However, it should be understood that the fibers 28 are present over a substantial portion of the length of the resilient primary coil. In different embodiments fibers 28 are restricted to the intervening segment or to the distal and proximal pigtails. In a preferred embodiment, the fibers 28 are distributed along the entire length of the resilient primary coil; see Fig. 3.
  • the fibers 28 may be arranged as individual fibers or as clumps of fibers.
  • the fibers 28 are disposed on the primary coil using any of a number of suitable means.
  • the fibers 28 may be wrapped around or intertwined with the wire that forms the primary ⁇ oil 12.
  • the fibers may be bonded to the primary coil 12 using an appropriate adhesive.
  • Suitable fibers are made from biocompatible polymeric materials, such as polyesters.
  • Preferred polyester fibers include polyethylene terephthalate, which is commercially available as DacronTM (Du Pont).
  • the distal end 14 and the at least one turn 18 of the distal pigtail extend below the plane of the intervening segment 26 while the proximal end 16 and the at least one turn 20 of the proximal pigtail extend above the plane of the intervening segment 26.
  • the distal end 14 and the at least one turn 18 of the distal pigtail extend on the same side of the plane of the intervening segment 26 as the proximal end 16 and the at least one turn 20 of the proximal pigtail.
  • the longitudinal axis of the distal pigtail (defined as a line passing through the center of the at least one turn 18 of the distal pigtail and perpendicular to the plane of the turn) and the corresponding longitudinal axis of the proximal pigtail are approximately perpendicular to the plane of the intervening segment 26.
  • the longitudinal axes of both the proximal pigtail and the distal pigtail are roughly parallel to the plane of the intervening segment in the relaxed state.
  • a second embodiment of the present contraceptive microcoil 30 is formed from a resilient primary coil 32.
  • the resilient primary coil 32 The resilient primary coil
  • the contraceptive microcoil 30 has a distal end 34 and a proximal end 36.
  • the distal end 34 and the proximal end 36 are free from additional fittings such as endcaps or tips.
  • the structures of the secondary shape of the contraceptive microcoil comprise a distal pigtail comprising at least one turn 38 and an opposing proximal pigtail comprising at least one turn 40.
  • the proximal and distal pigtails each comprise stacks of about one to about ten turns. In one preferred embodiment, the distal and proximal pigtails comprise stacks of about one to about five turns. In another preferred embodiment, the distal and proximal pigtails comprise stacks of about two to about six turns. In one preferred embodiment, the distal and proximal pigtails have different numbers of turns.
  • the outer diameter 42 of the turn of the distal pigtail and the outer diameter 44 of the turn of the proximal pigtail in the unconstrained relaxed state ranges from about 1 mm to about 10 mm, preferably from about 1.5 mm to about 7.5 mm, more preferably from about 1.5 mm to about 5 mm. In one preferred embodiment, the outer diameter 42 of the turn of the distal pigtail and the outer diameter 44 of the turn of the proximal pigtail are both about 3 mm. In other embodiments, the outer diameter 42 of the turn of the distal pigtail may be different from that of the outer diameter 44 of the turn of the proximal pigtail. In one embodiment the outer diameter 42 of the turn of the distal pigtail is smaller than the outer diameter 44 of the turn of the proximal pigtail.
  • the distal end and proximal end may terminate within the boundary of the turn of the respective pigtail, as shown in Fig. 2 for both the distal end 34 and the proximal end 36. Alternatively, the either or both ends may extend beyond the boundary of the turn of the respective pigtail.
  • the intervening segment 46 is delimited by the distal pigtail and the proximal pigtail.
  • the intervening segment 46 is substantially straight in the relaxed state of the contraceptive microcoil, that is, the radius of curvature of intervening segment 46 is greater than the length of intervening segment 46.
  • the intervening segment 46 is about one cm to about ten cm in length. Preferably the intervening segment is about three to about seven cm in length.
  • the distal end 34 and the at least one turn 38 of the distal pigtail extend below the plane of the intervening segment 46 while the proximal end 36 and the at least one turn 40 of the proximal pigtail extend above the plane of the intervening segment 46.
  • the distal pigtail and the proximal pigtail are on opposite sides of the intervening segment 46, thereby increasing the volume occupied by the secondary shape of the contraceptive microcoil in its relaxed state.
  • the distal end 34 and the at least one turn 38 of the distal pigtail extend on the same side of the plane of the intervening segment 46 as the proximal end 36 and the at least one turn 40 of the proximal pigtail.
  • fibers are disposed along the primary coil 32.
  • the fibers may be arranged as individual fibers or as clumps of fibers.
  • the fibers may be intertwined with the wire that forms the primary coil 32.
  • the fibers may be bonded to the primary coil 32 using an appropriate adhesive.
  • Suitable fibers are made from biocompatible polymeric materials, such as polyesters.
  • Preferred polyester fibers include polyethylene terephthalate, which is commercially available as DacronTM (Du Pont).
  • Example 1 The contraceptive microcoil was constructed from 0.018 inch (0.46 mm) diameter platinum wire that was formed into a primary coil and having a secondary configuration of a distal pigtail about 0.12 inch (3 mm) in diameter comprising about two turns, a proximal pigtail about 0.12 inch (3 mm) in diameter comprising about four turns, and an intervening segment separating the distal pigtail from the proximal pigtail (Fig. 1, Fig. 3). The length of the intervening segment was either about two inches (5 cm), about 2.4 inches (6 cm), or about 2.75 inches (7 cm). Polyester fibers (polyethylene terephthalate, DacronTM, Du Pont) were deposed along the length of the microcoil. Rabbits were housed and maintained in compliance with the "Principles of
  • a contraceptive microcoil was placed in the fallopian tube and uterus of one side in each animal.
  • the contralateral tube and uterus served as an internal control.
  • Ten virgin female New Zealand White rabbits were fitted with contraceptive microcoils; two male New Zealand White rabbits were used for breeding purposes.
  • the body weight of the animals was 4.0 - 5.0 kg.
  • the animals were anesthetized by intramuscular (IM) injection with a combination of ketamine (30 g/kg IM), xylazine (5 mg/kg IM), and acepromazine (1 mg/kg IM). Additional doses of these drugs were administered intravenously as needed during the surgical procedure to maintain anesthesia at a level necessary for surgery.
  • the animals were placed supine on the fluoroscopy table and the vaginal region was prepped with povidone iodine solution. Fallopian tube catheterization was then performed using a technique similar to that of Thurmond et. al. (Thurmond, A., et al., Transvaginal fallopian tube catheterization in an animal model. Invest Radiol 1988; 23:818-821).
  • a double-port 18 French (F) Foley catheter with a 30 cc balloon (Bard, Covington, Ga), stiffened by an 8 F Lumax guiding catheter (Cook, Inc., Bloomington, IN) was used to catheterize the vagina (base catheter).
  • a 9 F Teflon transjugular catheter (Cook, Inc., Bloomington, IN) was used as an alternative to the Foley/Lumax combination.
  • the distal tip of the Foley catheter was cut off, and the catheter was inserted into the vagina with the aid of a water soluble lubricant (K-Y Jelly, Johnson and Johnson, Skillman, NJ).
  • the balloon was then inflated with 20-30 cc of air. Air was then injected through the Foley side port to distend the vaginal vault, thus allowing visualization of the two cervices.
  • a 5 F MPA Torcon catheter (Cook, Inc., Bloomington, IN) was introduced through the base catheter into one of the two cervices with the aid of a .035" Glidewire (Terumo, Piscataway, NJ, distributed by Medi-tech/Boston Scientific, Watertown, MA).
  • the uterine horn was opacified with iodinated contrast material (Hypaque 60, Nycomed, Inc., New York, NY) and air.
  • the 5 F catheter was advanced to the cornual region over a .035" Bentson guide wire (Cook, Inc, Bloomington, IN). In some cases, the 5 F catheter was successfully advanced into the interstitial segment of the fallopian tube in this manner.
  • a 3 F nylon catheter (Cook, Inc, Bloomington, IN) or a Tracker- 18 catheter (Target Therapeutics, Inc., Fremont, CA) was introduced coaxially to gain access to the fallopian tube with the aid of a .018" Torq-Flex (Cook, Inc., Bloomington, IN) guidewire or a .018" Glidewire.
  • a small amount of contrast was then injected, and fallopian tube patency was confirmed fluoroscopically in all cases.
  • the coil was always deployed through a 3 F nylon catheter because it was too large to pass through the lumen of a Tracker- 18 catheter.
  • the coil was pushed through the 3 F nylon catheter with the .018" Torq-Flex guidewire and deposited in a position spanning tubal isthmus, interstitial segment, cornual region, and part of uterine horn.
  • the choice of coil length was based on how far the 3 F catheter could be advanced into the fallopian tube.
  • the intent was to deposit the coil, such that two- thirds of its length would be in the fallopian tube and one third would be in the uterus. Positioning the coil in this manner would allow testing its contraceptive effectiveness, and, at the same time, leave the door open to snare retrieval of the coil and reversal of the contraceptive effect.
  • Final coil position was documented with a post-procedure hysterosalpingogram.
  • Rabbits were bred after a rest period of 13-15 days. Pregnancy was detected by palpation 10-14 days following the breeding session. The rabbits were then sacrificed before the expected delivery date. Abdomen and pelvis of all animals were grossly inspected for location of embryos, and presence or absence of abscesses, adhesions, ectopic pregnancies, or other abnormalities. The uteri and attached fallopian tubes and ovaries were removed, and a specimen radiograph obtained to re-evaluate coil position. The specimen was placed in formalin. In order to obtain tissue sections, it was necessary to remove the coil. This was accomplished after fixation by manually pulling on its uterine end.
  • Full thickness transverse sections were made of fallopian tube and uterine tissue surrounding the: (1) microcoil pigtail within the fallopian tube, (2) microcoil straight segment within the fallopian tube, (3) microcoil straight segment at the uterotubal junction, (4) microcoil pigtail within the uterine horn, (5) uterus below coil, (6) fallopian tube above coil, (7) contralateral fallopian tube, (8) and contralateral uterine horn.
  • the specimens w ⁇ re processed for histologic evaluation in accordance with standard procedures, stained with hematoxylin and eosin, and evaluated microscopically by a veterinary pathologist .
  • a contraceptive microcoil was inserted into one fallopian tube and uterine horn in each often rabbits.
  • the coil was advanced 1.5 cm - 6 cm (mean 3.25 cm) into the fallopian tube. There was a coil length of 1.5 - 5.5 cm (mean 3.05 cm) extending into the uterine horn.
  • the coil was inadvertently placed entirely into the fallopian tube (coil length 6 cm).
  • the coil was uterotubal in location. All fallopian tubes were demonstrated to be patent by selective salpingography prior to coil placement.
  • the fallopian tubes exposed to the coils contained focal circular compressed areas of the mucosa, lamina intestinal, and occasionally the muscular wall that correlated with the size and shape of the pigtail of the coil. There was atrophy and loss of jnucosal epithelial cells associated with the defects. There were occcasional heterophils, mild fibrovascular tissue proliferation within the adjacent lamina propria, and occasional mild proliferative changes within regenerating mucosal epithelium, including foci of squamous metaplasia. There were also occasional foci of coil associated refractile particles of polyester fibers that were partially surrounded by macrophages and multinucleated giant cells.
  • the uteri exposed to the contraceptive microcoils also contained focal circular compressed disrupted areas of the mucosa and lamina intestinal surrounding the pigtail of the coil, as well as epithelial cell degeneration and necrosis with mild numbers of heterophils in the adjacent lamina propria.
  • Some of the affected areas contained increased fibrous connective tissue and increased numbers of small caliber blood vessels within the lamina propria.
  • Mild focal proliferative or regenerative changes were seen within mucosal epithelium that contained enlarged nuclei with prominent nucleoli and occasional mitotic figures. There were also occasional mitotic figures within mesenchymal cells of the lamina limbal.
  • Sections from the nine gravid uteri, one non-gravid uterus, and the ten fallopian tubes not exposed to the contraceptive microcoils were normal. Sections from uteri caudal to the level of the coil were normal in seven rabbits and showed mild mucosal epithelial proliferative changes in three rabbits. Sections from fallopian tubes cephalad to the level of the microcoil were normal in all cases.
  • the coil used in this study prevented pregnancy and remained in position in all animals.
  • the relatively increased effectiveness may due to greater length of coil in the fallopian tube, different coil configuration, polyester fibers, or a combination of these factors.
  • the contraceptive action of the coil may also be due, at least in part, to a local IUD-like effect upon the uterine endometrium.
  • a contraceptive microcoil preferably placed in an uterotubal position, can be a safe, effective, and minimally invasive means of female sterilization.
  • Example 2 A contraceptive microcoil is retrievably placed in each of the fallopian tubes of a human female using a modification of the basic technique outlined in detail in Example 1. The sterilization provided by the contraceptive microcoil is reversed by removal of each contraceptive microcoil by snaring the proximal pigtail of the microcoil and pulling the contraceptive microcoil gently from the fallopian tube.
  • the contraceptive microcoil of the present invention is deployed in the human female with tubal catheterization techniques that are already in use for fallopian tube recanalization.
  • the procedure is less invasive and less costly than laparoscopic and hysteroscopic techniques because of simpler, less costly instrumentation, transvaginal rather than transperitoneal approach, and lack of need for anesthesiology support.
  • the design of the contraceptive microcoil also would minimize the incidence of associated uterine and tubal infection compared to the intrauterine device (IUD), since the contraceptive microcoil does not have a string extending into the vagina.
  • the contraceptive microcoil of the present invention can also be retrieved with a snare from a transcervical approach.
  • the patient is consented for the tubal sterilization procedure and is then placed in the dorsal lithotomy position on a fluoroscopic table.
  • the skin of the perineum is sterily prepared and draped using iodine-povidone solution (or HibiclensTM if iodine allergic).
  • a sterile speculum is inserted and the internal vaginal vault sterily prepared.
  • the patient is sedated to a level of light conscious sedation using midazolam and fentanyl administered intravenously.
  • the external cervical os is cannulated with a cervical canulation device designed for this purpose.
  • the inner lumen of the cervical cannulation device is large enough to accommodate coaxial introduction of a 5F to 7F 60 degree angled cather made of TeflonTM or other low friction material into the uterine cavity.
  • This angled catheter has an inner lumen of about .038 inch (0.965 mm).
  • the 60 degree angled design of angled catheter permits insertion of the tip of this catheter into the fallopian tube ostium at the uterotubal junction. Some of the time this can be done using the angled catheter only and some of the time this maneuver requires the use of guidewires.
  • a small amount of x-ray dye is injected into the tube to outline its contour and measure its length (this study is called a direct salpingogram). Based on the direct salpingogram, a contraceptive microcoil having the most appropriate length and pigtail configuration are chosen from among several available. Next, a small flexible catheter about 2.5F to 3.
  • OF in size e.g 3F polyethylene catheter by Cook, Inc., Bloomington, IN or Tracker- 18, Target Therapeutics, Tustin, CA
  • OF in size e.g 3F polyethylene catheter by Cook, Inc., Bloomington, IN or Tracker- 18, Target Therapeutics, Tustin, CA
  • angled catheter over a 0.10 inch (.254 mm) to .018 inch (.457 mm) highly torqueable and hydrophilic guidewire until the tip of the small flexible catheter lies in the distal isthmic or proximal ampullary portion of the fallopian tube.
  • the sterilization coil is then loaded into the hub of the small flexible catheter, and advanced using a coil pusher device, and deployed under fluoroscopic control into the fallopian tube so that the distal pigtail of the sterilization coil lies in the mid-ampullary portion of the fallopian tube.
  • the intervening segment of the contraceptive microcoil then occupies the isthmic and interstitial portions of the fallopian tube, and the proximal pigtail reforms into its coiled configuration of the relaxed state in the uterine horn near the uterotubal junction.
  • a similar procedure is performed to the contralateral fallopian tube.
  • hysterosalpingography is performed to assess the adequacy of coil deployment.
  • Microcoil retrieval is performed to reverse sterilization when appropriate.
  • the procedure involves consent of the patient and placement on a fluoroscopy table in the dorsal lithotomy position. Cannulation of the cervix occurs as outlined above using the same instrumentation.
  • the uterine end of the retrievably placed contraceptive microcoil is captured using a retrieval snare device (Amplatz Gooseneck Snare, Microvena, Vadnais Heights, MN), which is inserted coaxially through the cervical cannulation device device in place of angled catheter described above.
  • the inner component of the Amplatz Gooseneck Snare is a double nitinol wire, with a snare loop at the end. When deployed beyond its guiding catheter component, the Gooseneck Snare opens into a circular "lasso" configuration.
  • the snare loop is then placed around the uterine end of the microcoil and the double wire component withdrawn into the guiding catheter to close the snare tightly around the uterine end of the microcoil.
  • the microcoil is withdrawn from the fallopian tube with gentle traction.
  • the Amplatz Gooseneck Snare and the microcoil are removed from the uterus, cervix, and vagina, leaving the cervical cannulation device still in place.
  • the procedure is repeated to remove the microcoil in the contralateral fallopian tube.
  • a completion hysterosalpingogram is then performed to test for fallopian tubal patency and to confirm that the entire microcoil has been removed.

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  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
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  • Orthopedics, Nursing, And Contraception (AREA)

Abstract

L'invention concerne une microspirale contraceptive (10) constituant un dispositif de contraception approprié en vue d'une stérilisation féminine. La microspirale contraceptive (10) peut être placée de façon récupérable, et constitue ainsi un procédé de stérilisation réversible. Le dispositif de contraception est une microspirale contraceptive (10) comportant une spirale primaire (12) constituée d'un matériau biocompatible, et d'une forme secondaire dotée d'une partie distale en tire-bouchon, d'une partie proximale en tire-bouchon et d'un segment intermédiaire (26) délimité par les parties distale et proximale en tire-bouchon.
PCT/US1998/001146 1997-01-21 1998-01-21 Microspirale contraceptive transcervicale en platine Ceased WO1998031308A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU59267/98A AU5926798A (en) 1997-01-21 1998-01-21 Transcervical contraceptive platinum microcoil

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US3588497P 1997-01-21 1997-01-21
US60/035,884 1997-01-21

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WO1998031308A1 true WO1998031308A1 (fr) 1998-07-23

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Cited By (24)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1018991A4 (fr) * 1997-09-24 2001-10-04 Conceptus Inc Dispositifs et procedes transcervicaux de contraception, par occlusion des trompes de fallope
WO2007133222A1 (fr) * 2006-05-11 2007-11-22 Ams Research Corporation Systèmes pour boucher l'appareil génital faisant office de contraception
US7428904B2 (en) 1995-06-07 2008-09-30 Alien Technology Corporation Contraceptive transcervical fallopian tube occlusion devices and their delivery
US7934504B2 (en) 1999-08-23 2011-05-03 Conceptus, Inc. Deployment actuation system for intrafallopian contraception
US8100129B2 (en) 2007-08-28 2012-01-24 Conceptus, Inc. Methods and devices for occluding an ovarian pathway
US8984733B2 (en) 2013-02-05 2015-03-24 Artventive Medical Group, Inc. Bodily lumen occlusion
US9017351B2 (en) 2010-06-29 2015-04-28 Artventive Medical Group, Inc. Reducing flow through a tubular structure
US9034053B2 (en) 2004-02-25 2015-05-19 Femasys Inc. Methods and devices for conduit occlusion
US9095344B2 (en) 2013-02-05 2015-08-04 Artventive Medical Group, Inc. Methods and apparatuses for blood vessel occlusion
US9149277B2 (en) 2010-10-18 2015-10-06 Artventive Medical Group, Inc. Expandable device delivery
US9220880B2 (en) 2004-02-25 2015-12-29 Femasys Inc. Methods and devices for delivery of compositions to conduits
US9238127B2 (en) 2004-02-25 2016-01-19 Femasys Inc. Methods and devices for delivering to conduit
US9247942B2 (en) 2010-06-29 2016-02-02 Artventive Medical Group, Inc. Reversible tubal contraceptive device
US9402762B2 (en) 2004-02-25 2016-08-02 Femasys Inc. Methods and devices for conduit occlusion
US9554826B2 (en) 2008-10-03 2017-01-31 Femasys, Inc. Contrast agent injection system for sonographic imaging
US9636116B2 (en) 2013-06-14 2017-05-02 Artventive Medical Group, Inc. Implantable luminal devices
US9737308B2 (en) 2013-06-14 2017-08-22 Artventive Medical Group, Inc. Catheter-assisted tumor treatment
US9737306B2 (en) 2013-06-14 2017-08-22 Artventive Medical Group, Inc. Implantable luminal devices
US10070888B2 (en) 2008-10-03 2018-09-11 Femasys, Inc. Methods and devices for sonographic imaging
US10149968B2 (en) 2013-06-14 2018-12-11 Artventive Medical Group, Inc. Catheter-assisted tumor treatment
US10363043B2 (en) 2014-05-01 2019-07-30 Artventive Medical Group, Inc. Treatment of incompetent vessels
US10813644B2 (en) 2016-04-01 2020-10-27 Artventive Medical Group, Inc. Occlusive implant and delivery system
CN117122372A (zh) * 2023-09-28 2023-11-28 齐育医疗科技(泰州)有限公司 栓塞器械及栓塞系统
US12171463B2 (en) 2008-10-03 2024-12-24 Femasys Inc. Contrast agent generation and injection system for sonographic imaging

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3490456A (en) * 1967-04-14 1970-01-20 William M Kortum Intrauterine catheter anchor
US3858571A (en) * 1973-07-02 1975-01-07 Arthur I Rudolph Cornual plug
US4595000A (en) * 1982-03-15 1986-06-17 Jacques Hamou Tubular pessary as a contraceptive means

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3490456A (en) * 1967-04-14 1970-01-20 William M Kortum Intrauterine catheter anchor
US3858571A (en) * 1973-07-02 1975-01-07 Arthur I Rudolph Cornual plug
US4595000A (en) * 1982-03-15 1986-06-17 Jacques Hamou Tubular pessary as a contraceptive means

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* Cited by examiner, † Cited by third party
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US8327852B2 (en) 1995-06-07 2012-12-11 Conceptus, Inc. Occlusion devices and methods
US7428904B2 (en) 1995-06-07 2008-09-30 Alien Technology Corporation Contraceptive transcervical fallopian tube occlusion devices and their delivery
US7686020B2 (en) 1995-06-07 2010-03-30 Conceptus, Inc. Contraceptive transcervical fallopian tube occlusion devices and methods
US8066007B2 (en) 1995-06-07 2011-11-29 Conceptus, Inc. Contraceptive transcervical fallopian tube occlusion devices and their delivery
US8356599B2 (en) 1995-06-07 2013-01-22 Conceptus, Inc. Occlusion devices and methods
US8733361B2 (en) 1995-06-07 2014-05-27 Bayer Essure Inc. Occlusion devices and methods
US8171936B2 (en) 1995-06-07 2012-05-08 Conceptus, Inc. Contraceptive transcervical fallopian tube occlusion devices and methods
US8613282B2 (en) 1997-09-24 2013-12-24 Conceptus, Inc. Occlusion devices and methods
US8733360B2 (en) 1997-09-24 2014-05-27 Bayer Essure Inc. Occlusion devices and methods
EP1018991A4 (fr) * 1997-09-24 2001-10-04 Conceptus Inc Dispositifs et procedes transcervicaux de contraception, par occlusion des trompes de fallope
US7934504B2 (en) 1999-08-23 2011-05-03 Conceptus, Inc. Deployment actuation system for intrafallopian contraception
US8079364B2 (en) 1999-08-23 2011-12-20 Conceptus, Inc. Deployment actuation system for intrafallopian contraception
US8381733B2 (en) 1999-08-23 2013-02-26 Conceptus, Inc. Deployment actuation system
US8695604B2 (en) 1999-08-23 2014-04-15 Bayer Essure Inc. Deployment actuation system
US8584679B2 (en) 1999-08-23 2013-11-19 Conceptus, Inc. Deployment actuation system
US9597224B2 (en) 1999-08-23 2017-03-21 Bayer Healthcare Llc Deployment actuation system
US9308023B2 (en) 2004-02-25 2016-04-12 Femasys Inc. Methods and devices for conduit occlusion
US10292732B2 (en) 2004-02-25 2019-05-21 Femasys, Inc. Methods and devices for conduit occlusion
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US10111687B2 (en) 2004-02-25 2018-10-30 Femasys, Inc. Methods and devices for conduit occlusion
US9839444B2 (en) 2004-02-25 2017-12-12 Femasys Inc. Methods and devices for conduit occlusion
US9402762B2 (en) 2004-02-25 2016-08-02 Femasys Inc. Methods and devices for conduit occlusion
US9034053B2 (en) 2004-02-25 2015-05-19 Femasys Inc. Methods and devices for conduit occlusion
US9238127B2 (en) 2004-02-25 2016-01-19 Femasys Inc. Methods and devices for delivering to conduit
US9220880B2 (en) 2004-02-25 2015-12-29 Femasys Inc. Methods and devices for delivery of compositions to conduits
WO2007133222A1 (fr) * 2006-05-11 2007-11-22 Ams Research Corporation Systèmes pour boucher l'appareil génital faisant office de contraception
US8550085B2 (en) 2006-05-11 2013-10-08 Conceptus, Inc. Methods and apparatus for occluding reproductive tracts to effect 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
US10070888B2 (en) 2008-10-03 2018-09-11 Femasys, Inc. Methods and devices for sonographic imaging
US10172643B2 (en) 2008-10-03 2019-01-08 Femasys, Inc. Contrast agent generation and injection system for sonographic imaging
US9554826B2 (en) 2008-10-03 2017-01-31 Femasys, Inc. Contrast agent injection system for sonographic imaging
US12426923B2 (en) 2008-10-03 2025-09-30 Femasys Inc. Methods and devices for sonographic imaging
US11648033B2 (en) 2008-10-03 2023-05-16 Femasys Inc. Methods and devices for sonographic imaging
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US10258375B2 (en) 2008-10-03 2019-04-16 Femasys, Inc. Methods and devices for sonographic imaging
US11154326B2 (en) 2008-10-03 2021-10-26 Femasys Inc. Methods and devices for sonographic imaging
US11980395B2 (en) 2008-10-03 2024-05-14 Femasys Inc. Methods and devices for sonographic imaging
US9017351B2 (en) 2010-06-29 2015-04-28 Artventive Medical Group, Inc. Reducing flow through a tubular structure
US9451965B2 (en) 2010-06-29 2016-09-27 Artventive Medical Group, Inc. Reducing flow through a tubular structure
US9247942B2 (en) 2010-06-29 2016-02-02 Artventive Medical Group, Inc. Reversible tubal contraceptive device
US9149277B2 (en) 2010-10-18 2015-10-06 Artventive Medical Group, Inc. Expandable device delivery
US8984733B2 (en) 2013-02-05 2015-03-24 Artventive Medical Group, Inc. Bodily lumen occlusion
US9095344B2 (en) 2013-02-05 2015-08-04 Artventive Medical Group, Inc. Methods and apparatuses for blood vessel occlusion
US9107669B2 (en) 2013-02-05 2015-08-18 Artventive Medical Group, Inc. Blood vessel occlusion
US9737307B2 (en) 2013-02-05 2017-08-22 Artventive Medical Group, Inc. Blood vessel occlusion
US9737306B2 (en) 2013-06-14 2017-08-22 Artventive Medical Group, Inc. Implantable luminal devices
US10441290B2 (en) 2013-06-14 2019-10-15 Artventive Medical Group, Inc. Implantable luminal devices
US10149968B2 (en) 2013-06-14 2018-12-11 Artventive Medical Group, Inc. Catheter-assisted tumor treatment
US9737308B2 (en) 2013-06-14 2017-08-22 Artventive Medical Group, Inc. Catheter-assisted tumor treatment
US9636116B2 (en) 2013-06-14 2017-05-02 Artventive Medical Group, Inc. Implantable luminal devices
US11224438B2 (en) 2014-05-01 2022-01-18 Artventive Medical Group, Inc. Treatment of incompetent vessels
US10363043B2 (en) 2014-05-01 2019-07-30 Artventive Medical Group, Inc. Treatment of incompetent vessels
US10813644B2 (en) 2016-04-01 2020-10-27 Artventive Medical Group, Inc. Occlusive implant and delivery system
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