WO2020183461A1 - Dispositif intra-utérin et outil de retrait pour le diu - Google Patents

Dispositif intra-utérin et outil de retrait pour le diu Download PDF

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Publication number
WO2020183461A1
WO2020183461A1 PCT/IL2020/050281 IL2020050281W WO2020183461A1 WO 2020183461 A1 WO2020183461 A1 WO 2020183461A1 IL 2020050281 W IL2020050281 W IL 2020050281W WO 2020183461 A1 WO2020183461 A1 WO 2020183461A1
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WO
WIPO (PCT)
Prior art keywords
shaft
bulb
balls
tube
iud
Prior art date
Application number
PCT/IL2020/050281
Other languages
English (en)
Inventor
Irina SHAHAR
Original Assignee
Igsolutions
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 Igsolutions filed Critical Igsolutions
Publication of WO2020183461A1 publication Critical patent/WO2020183461A1/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
    • A61F6/06—Contraceptive devices; Pessaries; Applicators therefor for use by females
    • A61F6/14—Contraceptive devices; Pessaries; Applicators therefor for use by females intra-uterine type
    • A61F6/142—Wirelike structures, e.g. loops, rings, spirals
    • A61F6/144—Wirelike structures, e.g. loops, rings, spirals with T-configuration
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F6/00—Contraceptive devices; Pessaries; Applicators therefor
    • A61F6/06—Contraceptive devices; Pessaries; Applicators therefor for use by females
    • A61F6/14—Contraceptive devices; Pessaries; Applicators therefor for use by females intra-uterine type
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F6/00—Contraceptive devices; Pessaries; Applicators therefor
    • A61F6/06—Contraceptive devices; Pessaries; Applicators therefor for use by females
    • A61F6/14—Contraceptive devices; Pessaries; Applicators therefor for use by females intra-uterine type
    • A61F6/18—Inserters or removers ; Apparatus for loading an intra-uterine device into an insertion tube

Definitions

  • the present invention generally pertains to an intrauterine device and a device and method for insertion and removal of an intrauterine device.
  • Intrauterine devices are a common and very effective form of long-term contraception.
  • an IUD is inserted into the uterus through the cervix and, at the end of use, is removed therefrom via the cervix.
  • a tool compresses the IUD and passes it through the cervix. The IUD is then disconnected from the tool and expands to an uncompressed shape, retaining it in the uterus.
  • a noticeable string a string that is too long or one that is noticeable during intercourse.
  • the IUD When the proximal end of the string is within the cervix, the IUD can be very difficult to remove. Very often, many attempts are needed before the device is removed, often requiring penetrating and painful action and the use of antibiotics. In some cases, the device must be removed in an operating room under full anesthesia. • Since the string comprises a foreign body in the cervical canal, it prevents formation of the mucus plug that normally prevents bacteria and vaginal fungi from entering the uterine cavity.
  • the string can entangle with a tampon or with a tampon removal string. This entanglement can cause the IUD to be removed from the body along with the tampon.
  • the IUD can perforate the uterine wall.
  • IUDs comprising copper can cause irregular menstruation including spotting between periods, irregular periods, heavier or longer periods and increased cramping during periods.
  • Insertion involves some pain and discomfort, often lasting for 3-6 days after insertion.
  • U.S Patent Application Publication No. US2017/0340476 discloses an enhanced intrauterine device comprising a body, at least one arm, at least one connector, a communication circuit, and a removal mechanism at a proximal end of the body.
  • the arm(s) can extend radially from the body and can be detached from the body.
  • the connector(s) link the arm(s) to the body so that the arm(s) remain linked to the body, independent of the arm(s) orientations with respect to the body.
  • the communication circuit can be coupled to the body or arm(s) and can respond to and transmit signals to external devices.
  • the system further comprises a removal tool which can separably couple to the removal mechanism.
  • the removal mechanism and the removal tool can comprise magnets to improve coupling.
  • the removal tool further comprises a mechanical grasping mechanism so that, after magnetic capture of the removal mechanism, the removal mechanism can be further held by the mechanical grasping mechanism during removal.
  • IUD intrauterine device
  • said ring being toroidal in said expanded configuration, said toroid having a toroid diameter and a toroid thickness, said toroid thickness being said ring thickness;
  • a total width of said IUD is said diameter of said toroid plus said ball diameter
  • each of said plurality of balls comprises material attractable to a magnet
  • said ring is configured, there being no external pressure on said ring, to automatically transform to said expanded configuration.
  • An insertion tool for an IUD comprising:
  • a pushing portion reversibly movable within said tube
  • said tube is configured to contain said IUD in a folded configuration; further wherein said pushing portion is configured, when moved distally within said tube, to induce said IUD to exit from a distal end of said tube.
  • An extraction tool for an IUD comprising:
  • a shaft movable within the tube said shaft having a proximal end and a distal end, said shaft reversibly movable within said tube;
  • a holder at said distal end of said tube said holder selected from a group consisting of a finger holder, a hook and a semilunar holder, said holder comprising a central magnet; wherein said central magnet is configured to magnetically attract and magnetically capture at least one ball of said IUD;
  • said holder is configured to prevent detaching of said IUD from said holder during proximal movement of said shaft.
  • said finger holder comprises a plurality of fingers, each one of said plurality of fingers attached to said shaft at a proximal end, each of said plurality of fingers having an external side and an internal side, said external side facing away from said shaft, said fingers reversibly closable, said fingers arranged circumferentially around said shaft.
  • a holding bulb comprises a thread therewithin, said thread being extrudable from said holding bulb, said holding bulb being selected from a group consisting of said bulbous connector and said tip bulb.
  • a receiving bulb is configured to retain said thread; for said holding bulb being said bulbous connector, said receiving bulb is said tip bulb; and for said holding bulb being said tip bulb, said receiving bulb is said bulbous connector.
  • said thread is retainable to said receiving bulb by means of a member selected from a group consisting of: a loop at the end of the thread passable around the receiving bulb; the thread passable through the receiving bulb and retainable by a barb at a distal end of said thread; a barb at the end of the thread buryable inside the receiving bulb; and any combination thereof.
  • An extraction tool for an IUD comprising:
  • a shaft movable within the tube said shaft having a proximal end and a distal end, said shaft reversibly movable within said tube;
  • a holder at said distal end of said tube said holder selected from a group consisting of a finger holder, a hook and a semilunar holder;
  • said holder is configured to engage with a portion of said IUD and, upon proximal movement of said shaft, said extraction tool is configured to draw said IUD into said tube and thereby laterally compress said IUD.
  • said finger holder comprises a plurality of fingers, each one of said plurality of fingers attached to said shaft at a proximal end, each of said plurality of fingers having an external side and an internal side, said external side facing away from said shaft, said fingers reversibly closable, said fingers arranged circumferentially around said shaft.
  • a holding bulb comprises a thread therewithin, said thread being extrudable from said holding bulb, said holding bulb being selected from a group consisting of said bulbous connector and said tip bulb.
  • a method of inserting an IUD into a uterus comprising steps of:
  • an insertion tool comprising:
  • a pushing portion reversibly movable within said tube
  • an IUD comprising:
  • a ring having a ring thickness, said ring having at least two configurations, an expanded configuration and a folded configuration; said ring reversibly transformable from said folded configuration to said expanded configuration; said ring being configured, in an absence of external pressure, to automatically transform to said expanded configuration;
  • said ring being toroidal in said expanded configuration, said toroid having a toroid diameter and a toroid thickness, said toroid thickness being said ring thickness; said ring being in said expanded configuration, a total width of said IUD is said diameter of said toroid plus said ball diameter;
  • said ring being in said folded configuration, a total width of said IUD being less than an interior diameter of said tube;
  • PET polyethylene terephthalate
  • PEEK polyetheretherketone
  • PVC polyvinyl chloride
  • PEI polypropylene
  • polysulfone polyurethane
  • said finger holder comprises a plurality of fingers, each one of said plurality of fingers attached to said shaft at a proximal end, each of said plurality of fingers having an external side and an internal side, said external side facing away from said shaft, said fingers reversibly closable, said fingers arranged circumferentially around said shaft.
  • a holding bulb comprises a thread therewithin, said thread being extrudable from said holding bulb, said holding bulb being selected from a group consisting of said bulbous connector and said tip bulb.
  • a method of removing an IUD from a uterus comprising steps of:
  • an extraction tool comprising:
  • a shaft movable within the tube said shaft having a proximal end and a distal end, said shaft reversibly movable within said tube;
  • a holder at said distal end of said tube said holder selected from a group consisting of a finger holder, a hook and a semilunar holder, said holder comprising a central magnet;
  • an IUD comprising:
  • a ring having a ring thickness, said ring having at least two configurations, an expanded configuration and a folded configuration; said ring reversibly transformable from said folded configuration to said expanded configuration; said ring being configured, in an absence of external pressure, to automatically transform to said expanded configuration; and
  • said ring being toroidal in said expanded configuration, said toroid having a toroid diameter and a toroid thickness, said toroid thickness being said ring thickness;
  • a total width of said IUD is said diameter of said toroid plus said ball diameter
  • PET polyethylene terephthalate
  • PEEK polyetheretherketone
  • PVC polyvinyl chloride
  • PEI polypropylene
  • polysulfone polyurethane
  • a method of removing an IUD from a uterus comprising steps of:
  • an extraction tool comprising:
  • a shaft movable within the tube said shaft having a proximal end and a distal end, said shaft reversibly movable within said tube;
  • a holder at said distal end of said tube said holder selected from a group consisting of a finger holder, a hook and a semilunar holder;
  • an IUD comprising:
  • a ring having a ring thickness, said ring having at least two configurations, an expanded configuration and a folded configuration; said ring reversibly transformable from said folded configuration to said expanded configuration; said ring being configured, in an absence of external pressure, to automatically transform to said expanded configuration; and
  • said ring being toroidal in said expanded configuration, said toroid having a toroid diameter and a toroid thickness, said toroid thickness being said ring thickness;
  • a total width of said IUD is said diameter of said toroid plus said ball diameter
  • PET polyethylene terephthalate
  • PEEK polyetheretherketone
  • PVC polyvinyl chloride
  • PEI polypropylene
  • polysulfone polyurethane
  • Fig. 1A-K, Fig. 2A-D, Fig. 3A-C and Fig. 4A-B show embodiments of the prior art
  • Fig. 5 illustrates a toroid
  • Fig. 6A-B schematically illustrates an embodiment of an IUD of the present invention
  • Fig. 7 schematically illustrates an embodiment of insertion tool before insertion, containing an IUD of the present invention
  • Fig. 8 schematically illustrates an embodiment of an extraction tool of the present invention
  • Fig. 9 schematically illustrates an embodiment of an extraction tool of the present invention with an embodiment of the IUD of the present invention, as retained by the extraction tool;
  • Fig. 10 schematically illustrates another embodiment of an extraction tool
  • Fig. 11 schematically illustrates retention of the IUD by a thread between two ends of a semilunar holder
  • Fig. 12A-B schematically illustrates distribution of balls around the ring
  • Figs. 13, 14A-B, 15 and 16A-B illustrate embodiments of an extraction tool
  • Fig. 17A-B illustrates an embodiment of an IUD of the present invention.
  • the term 'thickness' hereinafter refers to the thickness of the material of which the toroid is made.
  • the thickness is the diameter of the circular cross- section of the material.
  • the term 'diameter' hereinafter refers to the diameter of the toroid which includes the central hole, measured across the hole in the center of the toroid.
  • the thickness of a toroid can be determined by taking half of the difference between the outer diameter of the toroid (the size including the hole in the center and the two cross-sections) and the inner diameter of the toroid (the size of the hole in the center).
  • 'distal hereinafter refers to a location deeper in a body.
  • the uterus is distal to the cervix.
  • 'proximal hereinafter refers to a location closer to the exterior of a body.
  • the vagina is proximal to the cervix.
  • the present invention comprises a ring-shaped intrauterine device (IUD) with a plurality of magnetizable balls distributed around it, an insertion device to insert the IUD into a uterus and a removal device to remove the IUD from the uterus.
  • IUD intrauterine device
  • the magnetizable balls have a copper coating, copper being a known spermicide.
  • the removal device can also be used safely remove standard IUDs.
  • the balls have at least a partial coating of copper, a known spermicide.
  • Removal of the IUD uses an extraction tool which provides a simple mechanical process that eliminates the need for what has too often been, in the prior art, a complicated and painful process, often accompanied by negative side effects.
  • the string can be dislodged into the cervix by e.g. inserting a tampon, making removal difficult. o
  • the string can interfere with the formation of a cervical mucus plug, thereby increasing the chance of cervical and uterine infections
  • the string itself can be a route allowing bacteria to enter the uterus
  • the extraction tool comprises a shaft movable within a hollow tube.
  • a holder comprising a magnet.
  • the tube is inserted in the cervix with its distal end within the uterus.
  • the magnet at the distal end will engage with one of the magnetizable balls in the IUD.
  • the shaft is then retracted (moved proximally), causing the holder to attain a position which prevents the IUD from escaping from the holder. Further retraction of the shaft pulls the IUD into the tube, laterally compressing the IUD; the extraction device with attached compressed IUD can then be painlessly removed from the uterus and cervix.
  • the extraction tool can be used with both the IUD of the present invention and with prior-art IUDs.
  • IUDs intrauterine contraceptive devices
  • They typically comprise plastic, copper, silver and gold.
  • IUDs can prevent implantation of an egg by inflaming the walls of the uterus, or they can prevent fertilization of the egg, either by thickening cervical or uterine mucus so the sperm is prevented from reaching the egg, or by killing the sperm.
  • Mucal thickening is typically from one or more hormones released slowly from the IUD; spermicidal effects can be either from one or more hormones released slowly from the IUD or from copper or silver in or on the IUD, which dissolves slowly with time.
  • prior art IUDs are typically planar, having a length and width substantially greater than their depth.
  • prior art IUDs have at least one sharp terminus; most have more than one.
  • a sharp terminus can, at least under some conditions of use, contact tissue of the uterine interior and can, at least some of the time, damage this tissue and cause inflammation, and, in some cases, causing perforation of the uterus.
  • the termini are clearly intended to contact the uterine tissue.
  • prior art IUDs typically comprised one or more strings (10) (referred to hereinafter as“a string” or“the string”) that remain outside the cervix after installation and allow easy removal of the device.
  • a noticeable string a string that is too long or one that is noticeable during intercourse.
  • the IUD When the proximal end of the string is within the cervix, the IUD can be very difficult to remove. Very often, many attempts are needed before the device is removed, often requiring penetrating and painful action and the use of antibiotics. In some cases, the device must be removed in an operating room under full anesthesia.
  • the string comprises a foreign body in the cervical canal, it prevents formation of the mucus plug that normally prevents bacteria and vaginal fungi from entering the uterine cavity.
  • the string can entangle with a tampon or with a tampon removal string. This entanglement can cause the IUD to be removed from the body along with the tampon. • A monthly check needs to be performed to ensure that the device is still in position. Pulling on the string during the monthly check can result in inadvertent removal of the device.
  • the IUD can perforate the uterine wall.
  • IUDs comprising copper can cause irregular menstruation including spotting between periods, irregular periods, heavier or longer periods and increased cramping during periods.
  • Insertion involves some pain and discomfort, often lasting for 3-6 days after insertion.
  • Fig. 3A-C shows an embodiment of the prior-art IUB SCu300A (100), which comprises a NitinolTM wire (110) threaded with copper balls (120).
  • a removal string (130) is attached to a proximal end of the Nitinol wire (110).
  • Fig. 3A schematically illustrates the prior-art IUB SCu300A (100) in position in a uterus (90).
  • the released Nitinol wire (110) reshapes itself into a ball shape comprising two approximate circles (102, approximately plan, and 104, approximately edge-on) at approximately right angles to each other.
  • Fig. 3B shows an early stage of insertion of the prior-art IUB SCu300A (100) into a uterus (90).
  • the prior-art IUB SCu300A (100) is exiting the insertion tool (200); a distal end (112) is clearly seen.
  • Fig. 3C shows an early stage of removal of the prior-art IUB SCu300A (100) from a uterus (90).
  • the proximal end of the removal string (130) is being pulled (not shown) from the cervix (not shown). This causes the proximal portion (114) of the prior-art IUB SCu300A (100) unwind and to pass down the uterus (90) towards the cervix.
  • the prior-art IUB SCu300A (100) will unwind completely until it has passed entirely out of the body.
  • the prior-art IUB SCu300A (100) comprises two terminal ends, a proximal terminal end and a distal terminal end, with a ball covering the terminus of each terminal end.
  • the Nitinol wire is curved so that, if there is no pressure on the sides of the circles (102, 104), there is only a small gap at most between the terminal balls.
  • pressure on the circles can cause the terminal ends to move away from each other and for one or the other to press on the uterine tissue, which can cause discomfort or pain, and, if continued, can cause damage or inflammation to the uterine tissue.
  • the terminal balls can press on the uterine tissue during insertion and removal of the device, increasing the discomfort or pain felt by the user during the process.
  • Fig. 4A-B shows an embodiment of an extraction tool (1200) for removing a T-shaped IUD from a uterus.
  • the device comprises a manipulating portion (1230) at its proximal end connected via a shaft (1220) to fingers (1210) at the distal end.
  • the distal end also comprises a magnet (not shown), preferably located between the fingers at the distal end of the manipulating portion (1230). Pushing on the proximal end of the manipulating portion (1230) extends the fingers (1210) at the distal end from the shaft (1220) and exposes the magnet.
  • the magnet is close enough to a magnetic portion at the proximal end of the IUD, the magnetic portion of the IUD is attracted to and drawn into contact with the distal magnet.
  • the IUD of the present invention comprises at least one ball fixed onto a toroid.
  • a toroid (500) is characterized by a diameter (510) and a cross-section (520) having a thickness (525).
  • the IUD of the present invention has a cross-section of circular shape, although, in some embodiments, the cross-section can be oval or elliptical.
  • the cross-section can be polygonal; in some less- preferred embodiments, the cross-section shape can be selected from a group consisting of circular, elliptical, oval, polygonal, lenticular and any combination thereof.
  • Fig. 6A-B shows an embodiment of an IUD of the present invention, with a plan view shown in Fig. 6A and side view in Fig. 6B, the side view rotated for clarity.
  • the IUD (1000) comprises a toroidal ring (1100) with 10 balls (1200) distributed around the ring in five pairs of two balls (1200).
  • the balls (1200) are fixed in position. In other embodiments, there can be more or fewer balls (1200), with the number of balls (1200) in a range from 1 to 50.
  • the diameter of the balls (1200) is 3 mm; ball (1200) diameter can be in a range from 2.5 mm to 3.5 mm.
  • the distance between balls (1200) is typically in the range of 4 mm to 7 mm. In the embodiment shown, the closer together balls (1200) are 4 mm apart, the further apart balls (1200), 7 mm apart.
  • the balls (1200) comprise both copper and a magnetic material, typically iron.
  • the copper provides an effective spermicidal effect by slow dissolution.
  • the balls (1200) are plated with a material selected from a group consisting of gold, platinum, copper and any combination thereof.
  • the magnetic material is not magnetized. In some embodiments, the magnetic material is magnetized so that the balls comprise a magnet.
  • the ring (1100) is made of a flexible biocompatible material, preferably a flexible polymer.
  • the flexible polymer can comprise polyethylene terephthalate (PET), polyetheretherketone (PEEK), polyvinyl chloride (PVC), polyethylene, polycarbonate, polyetherimide (PEI), polypropylene, polysulfone, polyurethane and any combination thereof.
  • the diameter of the ring (1100) is in a range of 12 mm to 20 mm.
  • the thickness of the ring (1100) is in a range from 0.1 mm to 1 mm.
  • the IUD (1000) is contained entirely within the uterus. There is no removal string or other entity extending outside the uterus during use.
  • the IUD (1000) of the present invention is inserted into the uterus by means of an insertion tool (2000), as schematically illustrated in Fig. 7.
  • the insertion tool (2000) comprises a tube (2100) and a pushing portion (2200) having a distal end (2210) configured, when the pushing portion (2200) is moved distally, to induce the IUD (1000) to move distally.
  • the IUD (1000) is placed within the tube (2100). To emplace the IUD (1000) in a uterus, the tube (2100) is passed through the cervix until the distal end of the tube (2100) has entered the uterus.
  • the pushing portion (2200) is then moved distally (black arrow), while the tube (2100) remains substantially stationary, until the IUD (1000) has passed out of the tube (2100) into the uterus. Once the IUD (1000) is outside of the tube (2100), the stiffness of the IUD (1000) material will cause it to unfold and regain its toroidal shape.
  • the insertion tool (2000) can then be removed from the cervix, leaving the IUD (1000) in position in the uterus.
  • the diameter of the tube (2100) is typically 3.5 mm to 4 mm.
  • the diameter of the tube (2100) can be in a range from the diameter of the balls (1200) plus the thickness of the ring (1100) to the diameter of the balls (1200) plus 10 mm.
  • the insertion tool (2000) is preferably single-use and disposable.
  • a biocompatible polymer comprising at least one member of a group consisting of polyethylene terephthalate (PET), polyetheretherketone (PEEK), polyvinyl chloride (PVC), polyethylene, polycarbonate, polyetherimide (PEI), polypropylene, polysulfone and polyurethane.
  • the IUD (1000) of the present invention is removed from the uterus by means of an embodiment of an extraction tool (3000), as schematically illustrated in Figs. 8 and 9.
  • the extraction tool (3000) comprises a tube (3100) and a movable portion (3200).
  • the movable portion (3200) comprises a shaft (3220) with a finger holder (3210) at its distal end and, preferably, a handle (3230) at its proximal end.
  • the finger holder (3210) comprises a plurality of fingers (3212) and a central magnet (3214).
  • the extraction tool (3000) preferably further comprises a signal which can indicate to a person removing the IUD that the ball has come into contact with the central magnet (3214).
  • the signal can be, for non-limiting example, a light, a sound and any combination thereof (not shown) at the proximal end of the extraction tool (3000).
  • the signal and the central magnet (3214) are in electrical connection with each other and with a power source (not shown), with the electric circuit being open in the region of the magnet (3214) unless a ball (1200) is in contact with the central magnet (3214).
  • the light is an LED.
  • the signal is connected to the movable portion (3200). In some embodiments, the signal is connected to the shaft (3220).
  • the fingers (3212) preferably automatically expand to a propeller-like configuration, as shown in Fig. 8, when there is no pressure on their external edges and can be automatically transformed to a holding configuration, as shown in Fig. 9, below, when pressure is applied to their external sides.
  • Such automatic expansion reversible expansion can be provided, for non-limiting example, by having the fingers (3212) flexible at their proximal ends or by having spring-loaded hinges connecting the fingers (3212) to the shaft (3220).
  • the tube (3100) In order to remove an IUD (1000) from a uterus, the tube (3100) is inserted through the cervix (not shown). When the distal end of the tube (3100) has entered the uterus, the proximal end of the shaft (3220) is pushed, for non-limiting example by the handle (3230), until the finger holder (3210) has exited the distal end of the tube (3100) and the fingers (3212) automatically reconfigure to the propeller-like configuration, exposing the magnet (3214).
  • the IUD (1000) is substantially circular and the balls (1200) spaced around the circle, at least one of the balls (1200) will be within range of the magnetic force of the magnet (3214), will be attracted towards the magnet (3214) and will move towards it until the ball (1200) contacts the magnet (3214).
  • an electrical circuit is completed, activating a signal to inform the person removing the IUD (1000) that the ball (1200) is in contact with the magnet (3214).
  • the proximal end of the movable portion (3200) can then be pulled in a proximal direction while the tube (3100) remains substantially stationary, pulling the finger holder (3210), and therefore the ball (1200) attached to the IUD (1000), into the tube (3100), as shown in Fig. 9.
  • the finger holder (3210) enters the tube (3100)
  • the fingers (3214) are pressed inward into the holding configuration, securely retaining the ball (1200).
  • the ball (1200) will then be drawn entirely into the tube (3100) as shown in Fig. 9, transferring to a narrow, folded configuration, by further proximal motion of the movable portion (3200).
  • the extraction tool (3000) and IUD (1000) can be easily removed from the cervix with the minimum of discomfort to the woman.
  • the extraction tool (3000) and IUD (1000) can be removed from the cervix once the finger holder’s fingers (3214) are fully in the holding configuration, although, since the IUD (1000) will not be fully in the folded configuration, its effective cross-sectional area will be greater than the width of the extraction tool (3000), this will be more painful for the woman.
  • a single tool is used both for insertion (2000) and removal (3000) of the IUD.
  • Fig. 10 shows another exemplary embodiment of an extraction tool (3000).
  • the extraction tool (3000) comprises a tube (3100) and a movable portion (3200).
  • the movable portion (3200) comprises a shaft (3220) with a semilunar holder (3240) at its distal end and, preferably, a handle (3230) at its proximal end.
  • the semilunar holder (3240) comprises a central magnet (3244).
  • the proximal end of the semilunar holder (3240) is connected to the shaft (3220) via a bulbous connector (3246); a tip bulb (3248) is at the tip of the distal end of the semilunar holder (3240).
  • the tip bulb (3248) ensures that the distal end of the semilunar holder (3240) is blunt and can not cause trauma to the uterine tissue.
  • the tube (3100) In order to remove an IUD (1000) from a uterus, the tube (3100) is inserted through the cervix (not shown). When the distal end of the tube (3100) has entered the uterus, the proximal end of the shaft (3220) is pushed, for non-limiting example by the handle (3230), until the semilunar holder (3240) has exited the distal end of the tube (3100). Since the IUD (1000) is substantially circular and the balls (1200) are spaced around the circle, at least one of the balls (1200) will be within range of the magnetic force of the central magnet (3244), will be attracted towards the central magnet (3244) and will move towards it until the ball (1200) contacts the central magnet (3244). In some embodiments, when the ball (1200) has contacted the central magnet (3244), an electrical circuit is completed, activating a signal to inform the person removing the IUD (1000) that the ball (1200) is in contact with the central magnet (3244).
  • the proximal end of the movable portion (3200) can then be pulled in a proximal direction while the tube (3100) remains substantially stationary, pulling the semilunar holder (3240), and therefore the ball (1200) attached to the IUD (1000), into the tube (3100).
  • the tip bulb (3248) has a diameter large enough that the gap between the tip bulb (3248) and the tube (3100) is smaller than the diameter of the balls (1200) so that, when the tip bulb (3248) of the semilunar holder (3240) has entered the tube (3100), at least one ball (1200) is securely retained therein and the IUD (1000) can not slip out of the semilunar holder during removal of the extraction tool (3000) from the cervix.
  • the IUD (1000) will then be drawn entirely into the tube (3100) as shown in Fig. 9, transferring to a narrow, folded configuration, by further proximal motion of the movable portion (3200).
  • the extraction tool (3000) and IUD (1000) can be easily removed from the cervix with the minimum of discomfort to the woman.
  • the IUD is prevented from detaching from the extraction tool (3000) during proximal movement of the shaft (3220) by the tip bulb (3248).
  • At least one of the bulbous connector (3246) and the tip bulb (3248) is a holding bulb which comprises a thread (not shown) stored inside.
  • the thread (not shown) can be extruded from the holding bulb and can be connected to the other, receiving, bulb.
  • the connection can be by means of passing a loop at the end of the thread around the receiving bulb and tightening the thread; passing the thread through the receiving bulb, the thread having a barb at the end to prevent retraction through the receiving bulb; a barb at the end of the thread being buried inside the receiving bulb; and any other conventional means of keeping a thread in contact with an object.
  • the extraction tool (3000) is inserted into the cervix until the distal end of the tube (3100) has entered the uterus.
  • the movable portion (3200) is then moved distally until the semilunar holder (3240) is free of the tube (3100).
  • the central magnet (3244) At this point, at one of the balls (1200) in the IUD (1000) will be close enough to the central magnet (3244) that it will be attracted to the central magnet (3244) and come into contact with it.
  • the thread (3242) is extruded from the holding bulb. As schematically illustrated in Fig. 11, the extruded thread (3242) can be passed through the central open space of the toroidal ring (1100) of the IUD (1000) and connect to the other bulb, thereby preventing the IUD (1000) from separating from the extraction tool (3000).
  • the extraction tool (3000) preferably further comprises a signal which can indicate to a person removing the IUD that the ball has come into contact with the central magnet (3244).
  • the signal can be, for non-limiting example, a light, a sound and any combination thereof (not shown) at the proximal end of the extraction tool (3000).
  • the signal and the central magnet (3244) are in electrical connection with each other and with a power source (not shown), with the electric circuit being open in the region of the magnet (3244) unless a ball (1200) is in contact with the central magnet (3244).
  • the light is an LED.
  • the signal is connected to the movable portion (3200). In some embodiments, the signal is connected to the shaft (3220).
  • the extraction tool (2000, 3000) can also be used for removal of prior-art IUDs, for non-limiting example, the standard T-shaped IUD.
  • an extraction tool (2000, 3000) for removal of a prior-art IUD has no magnet although it is otherwise identical to an extraction tool (2000, 3000) for removal of an IUD of the present invention.
  • the extraction tool (2000, 3000) is inserted into the uterus, as disclosed above. The shaft is then advanced until the holder (3210, 3240) can engage with a portion of the prior-art IUD.
  • the shaft is then retracted (moved proximally), until at least a portion of the prior-art IUD, and preferably, a sufficient amount of the prior-art IUD to laterally compress the prior-art IUD, has entered the tube.
  • the extraction tool (2000, 3000), with captured prior-art IUD can then be removed from the body.
  • the IUD of the present invention can be folded in half for insertion into the uterus and for removal from the uterus; in a folded configuration, the effective diameter of the IUD of the present invention is substantially the diameter of the balls (1200) plus the thickness of the ring
  • the balls (1200) are arranged around the ring (1100) so that, when the ring (1100) is folded with a ball (1200) being located in the center of one of the two folds, the remainder of the balls (1200) are staggered (Fig. 12A, desired), thus minimizing the effective total width of the folded IUD (1000), with the effective total width (1290) being the ball diameter plus the ring thickness. If, on the other hand, the balls are not staggered, at least two balls (1200) being opposite each other (Fig. 12B, undesired), the effective total width (1290) of the folded IUD (1000) is twice the ball diameter.
  • Figs. 13 and 14A-B illustrate another embodiment of an extraction tool (3000), with Fig. 13 showing the extraction tool (3000), Fig. 14A showing the proximal end of the extraction tool (3000), and Fig. 14B showing the distal end of the extraction tool (3000),
  • the extraction tool (3000) comprises a tube (3100) and a movable portion (3200), the movable portion (3200) comprising a shaft (3220) with a finger holder (3210) at its distal end and a handle (3230) at its proximal end.
  • the finger holder (3210) comprises a plurality of fingers (3212) and can also comprise a central magnet (not shown).
  • the tube (3100) is shown semitransparent, so that the shaft can be more clearly seen.
  • the shaft (3220) comprises a detent (Fig. 14A, 3225) to limit travel of the movable portion (3200) relative to the tube (3100).
  • the movable portion (3200) can be moved distally or proximally relative to the tube (3110).
  • the fingers (3212) can rotate inward toward and outward (Fig. 14B, grey arrow) from the axis of the device, being hinged at their junction with the shaft (3220).
  • the fingers (3212) are in their outwardmost position; as the handle (3220) is moved proximalward relative to the tube (3100), the distalmost portion of the tube (3100) contacts the fingers (3212) and, by pressure on the fingers’ (3212) outward edges, presses the fingers (3212) inward, thus retaining an IUD (1000) located between the fingers (3212) during removal of the IUD (1000) from the uterus.
  • the fingers (3212) are fully rotated inward with the tips of the fingers touching.
  • the movable portion (3200) is in its most distalward position, for example, for capture of an IUD (1000), the fingers (3212) are fully rotated outward with the tips of the fingers splayed.
  • the detent (3225) limits proximalward motion and also enables a user to be certain that the fingers (3212) are fully rotated inward.
  • Figs. 15 and 16A-B illustrate another embodiment of an extraction tool (3000), with Fig. 15 showing the extraction tool (3000), Fig. 16A showing the proximal end of the extraction tool (3000), and Fig. 16B showing the distal end of the extraction tool (3000),
  • the extraction tool (3000) comprises a tube (3100) and a movable portion (3200), the movable portion (3200) comprising a shaft (3220) with a hook (3250) at its distal end and a handle (3230) at its proximal end.
  • the hook (3250) can also comprise a magnet (not shown).
  • the tube (3100) is shown semitransparent, so that the shaft can be more clearly seen.
  • the movable portion (3200) can be moved distally or proximally relative to the tube (3110).
  • the movable portion (3200) When the movable portion (3200) is in its distalmost position relative to the tube (3110), there is a gap between the tube (3110) and the hook (3250), allowing capture of an IUD (1000).
  • the movable portion (3200) When the movable portion (3200) is in its proximalmost position relative to the tube (3110), either there is contact between the hook (3240) and the tube (3100) or the hook (3250) has been withdrawn into the tube (3100), preventing escape of the IUD (1000) from the extraction tool
  • the IUD (1000) is captured by the extraction tool (3000) for removal from the uterus, but the IUD (1000) is not drawn within the extraction tool (3000) for removal, the toroidal ring (1100) being flexible enough to be folded by the tissue without causing discomfort to the user.
  • the IUD (1000), once captured by the extraction tool (3000), is drawn within the extraction tool (3000) for removal from the uterus, so that the width of the IUD (1000) is minimized before removal.
  • Fig. 17A-B shows another embodiment of an IUD (1000), with Fig. 17A showing a front view and Fig. 17B showing a side view, rotated slightly for clarity.
  • the IUD (1000) comprises a toroidal ring (1100) and five pairs of balls (1200).
  • the balls (1100) are large enough that the toroidal ring (1100) can not be completely folded, as the balls (1200) will contact each other before they can contact the opposite half of the toroidal ring (1100).
  • the extraction tool (3000) can be entirely single-use and disposable.
  • it comprises a biocompatible polymer comprising at least one member of a group consisting of polyethylene terephthalate (PET), polyetheretherketone (PEEK), polyvinyl chloride (PVC), polyethylene, polycarbonate, polyetherimide (PEI), polypropylene, polysulfone and polyurethane.
  • PET polyethylene terephthalate
  • PEEK polyetheretherketone
  • PVC polyvinyl chloride
  • PEI polypropylene
  • polysulfone polyurethane
  • the extraction tool (3000) can comprise a single -use, disposable portion and a reusable, autoclavable portion.
  • the autoclavable portion comprises the semilunar holder (3240) with its attached connecting bulb (3246), tip bulb (3248) and magnet (3244), the remainder of the extraction tool (3000) being single-use and disposable.
  • the semilunar holder (3240) with its attached connecting bulb (3246) and tip bulb (3248) are of metal, preferably stainless steel.

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  • Health & Medical Sciences (AREA)
  • Reproductive Health (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Surgical Instruments (AREA)

Abstract

L'Invention concerne un dispositif intra-utérin (DIU), un outil d'insertion et un outil d'extraction. Le DIU se présente sous la forme d'un anneau comprenant de nombreuses billes attachées de manière fixe à ce dernier et réparties autour de ce dernier. L'anneau peut passer de manière réversible d'une configuration déployée à une configuration pliée, la configuration pliée n'étant pas plus large que le double du diamètre des billes. Lors de la libération de la pression sur l'anneau, il passe automatiquement en configuration déployée. L'outil d'insertion comprend un tube pour maintenir l'anneau entier en configuration pliée, et une partie mobile pour pousser l'anneau hors du tube. L'outil d'extraction comprend un tube, possédant une partie mobile passant à travers ce dernier. L'extrémité distale de la partie mobile comprend un dispositif pour saisir et retenir le DIU afin que le DIU capturé ne puisse s'échapper du dispositif de retrait pendant le retrait du DIU hors de l'utérus.
PCT/IL2020/050281 2019-03-10 2020-03-10 Dispositif intra-utérin et outil de retrait pour le diu WO2020183461A1 (fr)

Applications Claiming Priority (2)

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US201962816129P 2019-03-10 2019-03-10
US62/816,129 2019-03-10

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Publication Number Publication Date
WO2020183461A1 true WO2020183461A1 (fr) 2020-09-17

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3805777A (en) * 1972-07-20 1974-04-23 A Ansari Intrauterine device and means for inserting and removing the same
US4026281A (en) * 1973-10-12 1977-05-31 Ortho Pharmaceutical Corporation Method and apparatus for inserting an intrauterine contraceptive device
CN101234052A (zh) * 2007-02-01 2008-08-06 柳葆光 磁性节育环和取环器
US20170340476A1 (en) * 2016-05-25 2017-11-30 Martin Kuster Enhanced intrauterine device
CN109394413A (zh) * 2018-12-08 2019-03-01 滨州职业学院 一种圆形iud取环钩

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3805777A (en) * 1972-07-20 1974-04-23 A Ansari Intrauterine device and means for inserting and removing the same
US4026281A (en) * 1973-10-12 1977-05-31 Ortho Pharmaceutical Corporation Method and apparatus for inserting an intrauterine contraceptive device
CN101234052A (zh) * 2007-02-01 2008-08-06 柳葆光 磁性节育环和取环器
US20170340476A1 (en) * 2016-05-25 2017-11-30 Martin Kuster Enhanced intrauterine device
CN109394413A (zh) * 2018-12-08 2019-03-01 滨州职业学院 一种圆形iud取环钩

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
BARAM, ILAN ET AL.: "The IUB, a newly invented IUD: a brief report", CONTRACEPTION, vol. 89.2, 2014, pages 139 - 141, XP055740231 *

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