Delaying premature birth

Abstract

A device for delaying labor, forming a lumen for surrounding a cervix, the device comprising an upper ring for surrounding the cervix, and an anchoring mechanism for anchoring the device on the cervix. A tool for inserting a device for delaying labor, the device comprising a device lumen for surrounding a cervix, the tool comprising a plurality of rods connected to two rings to form a longitudinal tool lumen, each rod comprising a connector at a distal end of the rod for connecting to the device for delaying labor, and a mechanism at a proximal end of the rod for detaching the device for delaying labor located at the distal end of the rod. Associated apparatus and methods are also described.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application is related to and claims priority from U.S. Provisional Patent Application No. 62 / 687,841, filed on June 21, 2018, and U.S. Provisional Patent Application No. 62 / 846,831, filed on May 13, 2019, the contents of which are incorporated herein by reference as if fully set forth herein.

[0003] Technical Field and Background Technology

[0004] The present invention, in some embodiments thereof, relates to devices and methods for delaying premature labor or advancing early delivery, and more particularly, but not exclusively, to devices for insertion into the vagina and around the cervix and associated methods.

[0005] Preterm birth (birth between 24 and 37 weeks of gestation) is the leading cause of neonatal death and morbidity. Worldwide, 15 million babies are born prematurely each year. One million will die and another million will suffer from major lifelong complications: breathing problems, eating problems, or neurological disabilities: blindness, hearing loss, neurodevelopmental delays, or cerebral palsy. Babies born prematurely impose a huge financial burden on society. In the United States, costs associated with premature birth exceed $26 billion per year.

[0006] The main risks for spontaneous preterm delivery, which accounts for approximately 50% of preterm births, are previous preterm birth, twin or multiple pregnancy, short cervix, cervical insufficiency, uterine premature contractions (PMC), or a combination of these.

[0007] Treatments such as drugs and hormones, suturing the cervix (cerclage), and pessaries are often unsatisfactory in reducing the rate of spontaneous preterm birth.

[0008] The disclosures of all references throughout this specification, as well as the disclosures of all references mentioned within those references, are incorporated herein by reference. Summary of the invention

[0009] One aspect of some embodiments of the present invention involves inserting a device into a vagina for securely supporting the cervix, preventing progression of cervical dilatation, effacement, or funneling, and preventing or delaying premature delivery.

[0010] According to one aspect of some embodiments of the present invention, there is provided a device for delaying production, forming a tubular cavity for surrounding a cervix, the device comprising: an upper ring for surrounding the cervix, and an anchoring mechanism for anchoring the device on the cervix.

[0011] According to some embodiments of the present invention, further comprising a strap surrounding the anchoring mechanism.

[0012] According to some embodiments of the present invention, the anchoring mechanism comprises several anchoring elements.

[0013] According to some embodiments of the present invention, the anchoring mechanism comprises a needle. According to some embodiments of the present invention, the anchoring mechanism comprises a suture needle. According to some embodiments of the present invention, a shape of the needle can be selected from: 1 / 4 circle; 3 / 8 circle; 1 / 2 circle; 5 / 8 circle; compound curve; half curve (also known as ski); and half curves at both ends of a straight segment (also known as canoe).

[0014] According to some embodiments of the present invention, the method further comprises a mechanism for extending the needle from a surface of the anchoring mechanism.

[0015] According to some embodiments of the present invention, the method further comprises a spring for extending the needle from a surface of the anchoring mechanism.

[0016] According to some embodiments of the invention, the upper ring is elastic.

[0017] According to some embodiments of the invention, the upper ring comprises a spring.

[0018] According to some embodiments of the present invention, the plurality of anchoring elements include a protrusion toward an interior of the lumen, the protrusion being designed to resist movement of the anchoring elements along the tissue.

[0019] According to some embodiments of the present invention, the plurality of anchoring elements include an adhesive material directed into an interior of the lumen, designed to resist movement of the anchoring elements along the tissue.

[0020] According to some embodiments of the present invention, the plurality of anchoring elements comprises a sharp needle.

[0021] According to some embodiments of the present invention, the plurality of anchoring elements comprises a plurality of sharp pins.

[0022] According to some embodiments of the invention, the strap comprises an elastic ring surrounding the anchoring mechanism.

[0023] According to some embodiments of the present invention, the anchoring element includes a foot having a protrusion toward a cervical side, the protrusion having a shape selected from a group consisting of: a single rectangular protrusion toward a cervical side, a spherical protrusion toward the cervical side, two rectangular protrusions toward the cervical side, and a hemispherical protrusion, the rounded side of the hemisphere facing the cervical side or other shapes acting to anchor on the cervix.

[0024] The term "foot" is used herein to refer to a radial extension from the device for delaying labor radially inwardly toward a central axis of the device.

[0025] In some embodiments, the foot is a lower portion connected to a leg of the device, the term leg being used herein as defined elsewhere.

[0026] According to some embodiments of the present invention, the anchoring element comprises at least one pin facing a cervical side.

[0027] According to some embodiments of the present invention, at least some of the plurality of anchoring elements comprise a hole for suturing the device to the cervix.

[0028] According to some embodiments of the present invention, the plurality of anchoring elements are equidistantly distributed around the lumen.

[0029] According to some embodiments of the present invention, the plurality of anchoring elements are non-equidistantly distributed around the lumen.

[0030] According to some embodiments of the invention, the number of the plurality of anchoring elements is an even number in the range from two to twenty inclusive.

[0031] According to some embodiments of the invention, the number of the plurality of anchoring elements is an odd number in a range from three to twenty-one inclusive.

[0032] According to some embodiments of the present invention, there is further included a component for measuring data from the group consisting of: contraction, dilation of a cervix, and progress of labor.

[0033] According to some embodiments of the present invention, there is further included a component for collecting data from the group consisting of: contraction, dilation of a cervix and progress of labor.

[0034] According to some embodiments of the present invention, the method further comprises a component for fluidizing a drug.

[0035] According to some embodiments of the present invention, the device further comprises a component for collecting data related to premature birth.

[0036] According to some embodiments of the present invention, there is further included a component for collecting data related to full-term pregnancy.

[0037] According to some embodiments of the present invention, a component is further included for collecting data related to a condition of a fetus.

[0038] According to some embodiments of the present invention, a vibration mechanism is further included for soothing and relaxing.

[0039] According to one aspect of some embodiments of the present invention, a method for delaying labor is provided, the method comprising the steps of providing a device for delaying labor, the device forming a lumen for surrounding a cervix, inserting the device into a vagina so that the lumen surrounds the cervix, positioning the device so that the upper ring is in a vault and surrounds the cervix at a level adjacent to the internal os of the cervix, and placing the device so that the device clamps the cervix.

[0040] According to some embodiments of the invention, the device comprises an upper ring for surrounding the cervix and an anchoring mechanism for anchoring the device on the cervix.

[0041] According to some embodiments of the invention, the inserting comprises compressing the device to pass through a vaginal entrance. According to some embodiments of the invention, the inserting comprises compressing the device to pass through a vaginal entrance.

[0042] According to some embodiments of the invention, the inserting comprises twisting the device to pass through a vaginal entrance.

[0043] According to some embodiments of the invention, the inserting comprises twisting the device to pass through a speculum located within the vagina.

[0044] According to some embodiments of the invention, positioning the device so that the upper ring surrounds the cervix includes releasing compression of the device to assist the device in surrounding the cervix.

[0045] According to some embodiments of the present invention, positioning the device so that the upper ring surrounds the cervix includes expanding the device to assist the device in surrounding the cervix. In some embodiments, the upper ring is expanded so as to push the upper ring up along the cervix.

[0046] According to some embodiments of the invention, placing the device so that the upper ring surrounds the cervix comprises releasing the dilation of the device.

[0047] According to some embodiments of the invention, the device further comprises a band surrounding the device, and further comprises removing the band from around the device.

[0048] According to some embodiments of the present invention, the method further comprises withdrawing the strip from a patient's body.

[0049] According to some embodiments of the invention, the device clamps the cervix by compressing the cervix.

[0050] According to some embodiments of the invention, the device is anchored to the cervix by inserting at least one pin into the cervix.

[0051] According to some embodiments of the invention, the device further comprises passing a needle through cervical tissue.

[0052] According to some embodiments of the invention, the device comprises a plurality of anchoring elements, and further comprises suturing at least one of the plurality of anchoring elements to the cervix.

[0053] According to some embodiments of the present invention, further comprising attaching the device to a cervix using adhesive silicone.

[0054] According to some embodiments of the present invention, the method further comprises attaching the device to a cervix using a bioadhesive.

[0055] According to one aspect of some embodiments of the present invention, an insertion tool is provided for inserting a device for delaying childbirth through a vagina.

[0056] According to one aspect of some embodiments of the present invention, there is provided an insertion tool for inserting a device for delaying childbirth through an opening in the vagina.

[0057] In some embodiments, the insertion tool comprises a connector and / or a plurality of connector rods for connecting to a device for delaying production according to embodiments described herein.

[0058] In some embodiments, the insertion tool is configured to deliver other devices through a lumen, such as a vagina.

[0059] In some embodiments, the other device is optionally approximately annular, or at least has a generally annular base suitable for attachment to the insertion device.

[0060] In some embodiments, the insertion tool is configured to contract its width across at least one cross-sectional dimension, potentially enabling it to pass through a narrow lumen.

[0061] In some embodiments, the insertion tool may optionally be widened after having passed through the narrow lumen, optionally expanding and laterally pushing the sides of the lumen after having passed as a tool having a narrower shape.

[0062] According to one aspect of some embodiments of the present invention, there is provided an extension tool for clamping a cervix via a vagina.

[0063] In some embodiments, the clamping tool includes a plurality of jaws for clamping, adapted to extend through a narrow lumen and open at a distal end.

[0064] In some embodiments, the jaws may optionally open to a width of up to 5 cm, with the jaws not increasing in width over a majority of its length, for example more than 80% or 90% of its width.

[0065] In some embodiments, the plurality of jaws are configured to expand to a width that is greater than four times a width of the extension tool.

[0066] In some embodiments, a width of the extension tool along more than 80% or 90% of its length is less than 1 cm, for example 0.8 cm, and the jaws can open up to 5 cm.

[0067] In some embodiments, the jaws are expanded by controllers along a linear movement of the elongated jaws, unlike, for example, scissors, where handles are moved laterally to control the opening of the scissors. Such exemplary embodiments refer to Figures 14A to 14E and is described.

[0068] According to one aspect of some embodiments of the present invention, there is provided a device for delaying production, forming a lumen for surrounding a cervix, the device comprising: an upper ring for surrounding the cervix, and an anchor for anchoring the device on the cervix.

[0069] According to some embodiments of the invention, an inner diameter of the upper ring is larger than an inner diameter of the anchor, such that when an axial force is applied to the upper ring, toward the anchor, the force generates a rotational force for rotating the anchor toward the cervix.

[0070] According to some embodiments of the invention, an inner diameter of the upper ring is larger than an inner diameter of the anchor, such that when an axial force is applied to the upper ring, toward the anchor, the force generates a rotational force that rotates the anchor toward the cervix.

[0071] According to some embodiments of the invention, the anchor is configured to non-invasively anchor the device to the cervix. According to some embodiments of the invention, the anchor comprises a needle.

[0072] According to some embodiments of the invention, the anchor comprises several anchoring elements.

[0073] According to some embodiments of the present invention, the upper ring is constructed to leave a plurality of empty spaces or gaps inside the upper ring, so that the plurality of empty spaces or gaps do not compress the cervix.

[0074] According to some embodiments of the present invention, the plurality of anchoring elements leave a plurality of empty spaces or gaps around the lumen surrounding the cervix.

[0075] According to some embodiments of the present invention, each of the plurality of anchoring elements comprises a leg, and wherein the leg is configured to anchor to the cervix. The term "leg" herein is used for an extension extending from an upper portion of the device for delaying childbirth to a lower portion of the device, when the device is positioned to clamp a cervix, the direction is the opening of the vagina, or a direction of the vaginal opening.

[0076] According to some embodiments of the present invention, the plurality of anchoring elements comprises 3 to 7 anchoring elements.

[0077] According to some embodiments of the invention, the upper ring is more rigid than the legs.

[0078] According to some embodiments of the invention, the legs are more rigid than the upper ring.

[0079] According to some embodiments of the invention, the legs are elastic.

[0080] According to some embodiments of the present invention, further comprising a strap surrounding the anchoring mechanism.

[0081] According to some embodiments of the present invention, the strip comprises an elastic strip to generate radial pressure applied by the plurality of anchors to the cervix.

[0082] According to some embodiments of the invention, the strip comprises a metal ring.

[0083] According to some embodiments of the invention, the upper ring is elastic.

[0084] According to some embodiments of the invention, the upper ring comprises a spring. According to some embodiments of the invention, the upper ring comprises a metal ring.

[0085] According to some embodiments of the present invention, the upper ring includes a vibration mechanism. In some embodiments, the vibration mechanism includes a plurality of magnetic coils that vibrate when current passes through them. In some embodiments, the vibration mechanism includes a motor and an off-center load that creates vibrations when the motor rotates. In some embodiments, the device includes a battery for driving the vibration mechanism.

[0086] In some embodiments, the vibration mechanism comprises an eccentric rotating mass, as an unbalanced mass on a (optionally DC) motor or a linear resonant actuator comprising a small internal mass coupled to a spring, which creates a force when driven. The vibration can be a periodic, steady-state, transient or random vibration. The vibration can be harmonic or anharmonic.

[0087] According to some embodiments of the present invention, the anchoring element includes a foot having a protrusion toward a cervical side, the protrusion having a shape selected from a group consisting of: a single rectangular protrusion toward a cervical side, a spherical protrusion toward the cervical side, two rectangular protrusions toward the cervical side, and a hemispherical protrusion, the round side of the hemisphere facing the cervical side.

[0088] According to some embodiments of the invention, the protrusion is rigid.

[0089] According to some embodiments of the invention, the protrusion is elastic.

[0090] According to some embodiments of the present invention, the plurality of anchoring elements are equidistantly distributed around the lumen.

[0091] According to some embodiments of the present invention, the plurality of anchoring elements are non-equidistantly distributed around the lumen.

[0092] According to some embodiments of the present invention, there is further included a sensor for measuring data from the group consisting of: contraction, dilation of a cervix, and progress of labor.

[0093] According to some embodiments of the present invention, the method further comprises a transmitter for transmitting the data.

[0094] According to one aspect of some embodiments of the present invention, a method for delaying labor is provided, comprising the steps of: providing a device for delaying labor, the device forming a lumen for surrounding a cervix, inserting the device into a vagina so that the lumen surrounds the cervix, positioning the device so that the upper ring surrounds the cervix in a dome located at a level of the internal os of the cervix, and placing the device so that the device clamps the cervix.

[0095] According to some embodiments of the invention, placing the device so that the device clamps the cervix includes placing the device to compress the cervix and help prevent the cervix from opening, dilating, and funneling.

[0096] According to some embodiments of the invention, positioning the device so that the upper ring surrounds the cervix in a vault located at a level of the internal cervical os includes positioning the device so that the upper ring surrounds the cervix in a vault within 5 to 30 mm from a level of the internal cervical os.

[0097] According to some embodiments of the present invention, the device comprises: an upper ring for surrounding the cervix and an anchoring mechanism for anchoring the device on the cervix.

[0098] According to some embodiments of the invention, the inserting comprises: changing a shape of the device to pass through a vaginal opening or through a vagina.

[0099] According to some embodiments of the invention, the inserting comprises: changing a shape of the device to pass through an opener.

[0100] According to some embodiments of the invention, the inserting comprises twisting the device to pass through a vaginal opening.

[0101] According to some embodiments of the invention, the placing comprises twisting the device to pass through an opener.

[0102] According to some embodiments of the invention, positioning the device so that the upper ring surrounds the cervix includes releasing compression of the device to assist the device in surrounding the cervix.

[0103] According to some embodiments of the invention, positioning the device so that the upper ring surrounds the cervix includes expanding the device to assist the device in surrounding the cervix.

[0104] According to some embodiments of the present invention, the device further comprises a band surrounding the device, and further comprising: removing the band from around the device.

[0105] According to some embodiments of the invention, removing the strip from around the device comprises cutting the strip.

[0106] According to some embodiments of the invention, the device clamps the cervix by compressing the cervix.

[0107] According to one aspect of some embodiments of the present invention, there is provided a device for delaying production, forming a tubular cavity for surrounding a cervix, the device comprising: an upper ring for surrounding the cervix, an anchoring mechanism for anchoring the device on the cervix, and a pivot position, configured so that when the upper ring is pushed outward from an axis of the tubular cavity, the upper ring rotates around the pivot and releases the anchoring of the device on the cervix.

[0108] According to some embodiments of the present invention, the anchoring mechanism comprises a plurality of anchoring elements, each of the plurality of anchoring elements comprises a leg, and the leg is configured to anchor to the cervix.

[0109] According to some embodiments of the invention, the pivot mechanism comprises a strap surrounding the anchoring mechanism.

[0110] According to one aspect of some embodiments of the present invention, there is provided a tool for inserting a device for delaying childbirth, the device comprising a device lumen for surrounding a cervix, the tool comprising: a plurality of rods supported by a plurality of rings, forming a longitudinal, optionally circular tool lumen, each rod comprising: a connector at a distal end of the rod for connecting to the device for delaying childbirth, and a mechanism at a proximal end of the rod for detaching the device for delaying childbirth located at the distal end of the rod.

[0111] According to some embodiments of the present invention, the ring is elastic, allowing a cross-section of the longitudinal tool lumen to expand and contract.

[0112] According to some embodiments of the present invention, the tool is configured to connect rings of different sizes based on the ability of the cross-section of the longitudinal tool lumen to expand and contract.

[0113] According to some embodiments of the present invention, the tool further comprises a control rod for moving the plurality of rods closer to each other, thereby reducing a cross-section of the tool lumen.

[0114] According to some embodiments of the invention, moving the plurality of rods causes the plurality of rings to change an angle at which the plurality of rods are attached to the plurality of rings.

[0115] According to some embodiments of the present invention, the control rod for moving the plurality of rods closer to each other and / or causing the plurality of rods to tilt relative to the plurality of rings moves one or more rods longitudinally relative to one or more other rods, thereby forming an elliptical cross-section of the tool lumen.

[0116] According to some embodiments of the present invention, further comprising a handle coupled to at least one of the plurality of rods.

[0117] According to some embodiments of the invention, the control lever is connected to a hub included in the handle.

[0118] According to some embodiments of the present invention, in the insertion tool, there are several channels along the several rods, and the several channels allow bioadhesive or adhesive material or polysiloxane to be distributed to the several legs of the device before the release of the device for delaying labor to glue the device to the cervix.

[0119] According to one aspect of some embodiments of the present invention, there is provided a tool for clamping a cervix, comprising: two jaws for clamping a cervix, a hinge connecting the two jaws so that the jaws can be separated and closed from each other, an extension tool connected to the two jaws, and several controllers for opening and closing the two jaws, wherein the jaws are configured to expand to a width that is greater than 4 times a width of the extension tool.

[0120] According to some embodiments of the invention, each of the two jaws comprises a shape configured to clamp the cervix.

[0121] According to some embodiments of the present invention, the device further comprises a ruler for indicating a distance between the two jaws.

[0122] According to some embodiments of the present invention, the device further comprises a ruler for indicating an angle between the two jaws.

[0123] According to one aspect of some embodiments of the present invention, a method for delaying labor is provided, comprising the steps of: providing an insertion tool and a device for delaying labor connected to a distal end of the insertion tool, inserting the distal end of the insertion device into a vagina, manipulating the insertion tool so that the device surrounds a cervix, separating the device from the insertion tool to leave the device clamping the cervix and withdrawing the insertion tool from the vagina.

[0124] According to some embodiments of the present invention, the insertion tool is an insertion tool as described herein.

[0125] According to some embodiments of the present invention, the device for delaying production is a device for delaying production as described herein.

[0126] According to some embodiments of the present invention, the method further comprises reducing a cross-section of a lumen of the insertion tool before inserting the distal end of the insertion tool into the vagina.

[0127] According to some embodiments of the present invention, the inserting includes reducing a cross-section of a lumen of the insertion tool to allow passage of an opener.

[0128] According to some embodiments of the present invention, the method further comprises: before manipulating the insertion tool to allow the device to surround a cervix, expanding the cross-section of the insertion tool lumen.

[0129] According to some embodiments of the present invention, further comprising: manipulating the device to clamp the cervix as high as possible on the cervix.

[0130] According to some embodiments of the present invention, providing the insertion tool as described herein with the device connected to a distal end of the insertion tool further includes: providing a clamping tool as described herein for insertion through a lumen of the insertion tool.

[0131] According to some embodiments of the present invention, the method further comprises: after inserting the distal end of the insertion tool into the vagina, clamping the cervix with the clamping tool.

[0132] According to some embodiments of the present invention, the method further comprises: clamping the cervix with the clamping tool before inserting the distal end of the insertion tool into the vagina.

[0133] According to some embodiments of the present invention, it further comprises: before the separation of the device from the insertion tool, pulling the cervix with the clamp tool.

[0134] According to some embodiments of the present invention, the method further comprises: before the separation of the device from the insertion tool, pushing the insertion tool so as to push the device up along the cervix.

[0135] According to one aspect of some embodiments of the present invention, there is provided a device for delaying production, forming a lumen for surrounding a cervix, the device comprising: an upper ring for surrounding the cervix, and an anchor for anchoring the device on the cervix.

[0136] According to some embodiments of the invention, an inner diameter of the upper ring is larger than an inner diameter of the anchor, such that when an axial force is applied to the upper ring, toward the anchor, the force generates a force that pushes the anchor toward the cervix.

[0137] According to some embodiments of the invention, the anchor is configured to non-invasively anchor the device to the cervix.

[0138] According to some embodiments of the invention, the anchor comprises a needle.

[0139] According to some embodiments of the invention, the anchor comprises several anchoring elements.

[0140] According to some embodiments of the present invention, the upper ring includes a plurality of gaps around an inner side of the upper ring such that the plurality of gaps do not compress the cervix.

[0141] According to some embodiments of the present invention, the plurality of anchoring elements leave a plurality of gaps along the lumen for surrounding the cervix.

[0142] According to some embodiments of the invention, the upper ring is elastic.

[0143] According to some embodiments of the invention, the upper ring comprises a spring.

[0144] According to some embodiments of the invention, each of the plurality of anchoring elements comprises a leg, and wherein the leg is configured to anchor to the cervix.

[0145] According to some embodiments of the present invention, the plurality of anchoring elements comprises 3 to 7 anchoring elements.

[0146] According to some embodiments of the invention, the legs are more rigid than the upper ring.

[0147] According to some embodiments of the invention, the legs are elastic.

[0148] According to some embodiments of the present invention, further comprising a strap surrounding the anchoring mechanism.

[0149] According to some embodiments of the present invention, the strip comprises an elastic strip to generate radial pressure applied by the plurality of anchors to the cervix.

[0150] According to some embodiments of the invention, the strap comprises a spring.

[0151] According to some embodiments of the invention, the upper ring is elastic.

[0152] According to some embodiments of the invention, the upper ring comprises a spring.

[0153] According to some embodiments of the invention, the upper ring comprises a vibrating mechanism.

[0154] According to some embodiments of the invention, the upper ring comprises a metal ring.

[0155] According to some embodiments of the present invention, the anchoring element includes a foot having a protrusion toward a cervical side, the protrusion having a shape selected from a group consisting of: a single rectangular protrusion toward a cervical side, a spherical protrusion toward the cervical side, two rectangular protrusions toward the cervical side, and a hemispherical protrusion, the round side of the hemisphere facing the cervical side.

[0156] According to some embodiments of the invention, the protrusion is rigid.

[0157] According to some embodiments of the invention, the protrusion is elastic.

[0158] According to some embodiments of the present invention, the plurality of anchoring elements are equidistantly distributed around the lumen.

[0159] According to some embodiments of the present invention, the plurality of anchoring elements are non-equidistantly distributed around the lumen.

[0160] According to some embodiments of the present invention, an adhesive material is further included on an inner side of the anchoring element.

[0161] According to some embodiments of the present invention, there is further included a sensor for measuring data from the group consisting of: contraction, dilation of a cervix, and progress of labor.

[0162] According to some embodiments of the present invention, the method further comprises a transmitter for transmitting the data.

[0163] According to some embodiments of the present invention, the method further comprises a component for fluidizing a drug.

[0164] According to one aspect of some embodiments of the present invention, a method for delaying labor is provided, the method comprising the steps of providing a device for delaying labor, the device forming a lumen for surrounding a cervix, inserting the device into a vagina so that the lumen surrounds the cervix, positioning the device so that the upper ring surrounds the cervix in a dome located at a level of the internal os of the cervix, and placing the device so that the device clamps the cervix.

[0165] According to some embodiments of the invention, placing the device so that the device clamps the cervix includes placing the device to compress the cervix and help prevent the cervix from opening, dilating, and causing the cervix to funnel.

[0166] According to some embodiments of the invention, positioning the device so that the upper ring surrounds the cervix in a vault located at a level of the internal cervical os includes positioning the device so that the upper ring surrounds the cervix in a vault within 5 mm of a level of the internal cervical os.

[0167] According to some embodiments of the present invention, the device comprises: an upper ring for surrounding the cervix and an anchoring mechanism for anchoring the device on the cervix.

[0168] According to some embodiments of the invention, the inserting comprises: changing a shape of the device to pass through a vaginal opening.

[0169] According to some embodiments of the invention, the inserting comprises: changing a shape of the device to pass through an opener.

[0170] According to some embodiments of the invention, the inserting comprises twisting the device to pass through a vaginal opening.

[0171] According to some embodiments of the invention, the placing comprises twisting the device to pass through an opener.

[0172] According to some embodiments of the invention, positioning the device so that the upper ring surrounds the cervix includes releasing compression of the device to assist the device in surrounding the cervix.

[0173] According to some embodiments of the present invention, positioning the device so that the upper ring surrounds the cervix includes expanding the device for delaying labor to assist the device in moving more easily upward along the cervix.

[0174] According to some embodiments of the present invention, the device further comprises a band surrounding the device, and further comprises: removing the band from around the device.

[0175] According to some embodiments of the present invention, the device comprises: an upper ring for surrounding the cervix and an anchoring mechanism for anchoring the device on the cervix.

[0176] According to some embodiments of the invention, the inserting comprises: changing a shape of the device to pass through a vaginal opening.

[0177] According to some embodiments of the invention, the inserting comprises: changing a shape of the device to pass through an opener.

[0178] According to some embodiments of the invention, the inserting comprises twisting the device to pass through a vaginal opening.

[0179] According to some embodiments of the invention, the inserting comprises rotating the device to pass through a vaginal opening.

[0180] According to some embodiments of the invention, the placing comprises twisting the device to pass through an opener.

[0181] According to some embodiments of the invention, positioning the device so that the upper ring surrounds the cervix comprises releasing compression of the device to assist the device in surrounding the cervix.

[0182] According to some embodiments of the present invention, positioning the device so that the upper ring surrounds the cervix includes expanding the device for delaying labor to assist the device in moving upward along the cervix more easily.

[0183] According to some embodiments of the present invention, the device further comprises a band surrounding the device, and further comprises: removing the band from around the device.

[0184] According to some embodiments of the invention, removing the strip from around the device comprises cutting the strip.

[0185] According to some embodiments of the invention, the device clamps the cervix by compressing the cervix.

[0186] According to one aspect of some embodiments of the present invention, there is provided a device for delaying production, forming a tubular cavity for surrounding a cervix, the device comprising: an upper ring for surrounding the cervix, an anchoring mechanism for anchoring the device on the cervix, and a pivot position, configured so that when the upper ring is pushed outward from an axis of the tubular cavity, the upper ring rotates around the pivot and releases the anchoring of the device on the cervix.

[0187] According to some embodiments of the present invention, the anchoring mechanism comprises a plurality of anchoring elements, each of the plurality of anchoring elements comprises a leg, and the leg is configured to anchor to the cervix.

[0188] According to some embodiments of the invention, the pivot mechanism comprises a strap encircling the anchoring mechanism.

[0189] According to one aspect of some embodiments of the present invention, there is provided an insertion tool for inserting a device for delaying childbirth, the device comprising a device lumen for surrounding a cervix, the tool comprising: a plurality of rods connected to at least two rings to form a longitudinal tool lumen, each rod comprising: a connector at a distal end of the rod for connecting to the device for delaying childbirth, and a mechanism at a proximal end of the rod for separating the device for delaying childbirth located at the distal end of the rod.

[0190] According to some embodiments of the present invention, the plurality of rods are elastically coupled to the plurality of rings, allowing for expansion and contraction of a cross-section of the longitudinal tool lumen.

[0191] According to some embodiments of the present invention, the plurality of rings are elastic, allowing a cross-section of the longitudinal tool lumen to expand and contract.

[0192] According to some embodiments of the present invention, based on the ability of the longitudinal tool lumen to expand and contract its cross-section, it is configured to connect devices for delaying production of different sizes.

[0193] According to some embodiments of the present invention, the method further comprises a control rod for moving the plurality of rods closer to each other, thereby reducing a cross-section of the tool lumen.

[0194] According to some embodiments of the invention, moving the plurality of rods causes the plurality of rings to change an angle at which the plurality of rods are attached to the plurality of rings.

[0195] According to some embodiments of the present invention, the control rod for moving the plurality of rods closer to each other moves one or more rods longitudinally relative to one or more other rods to form an elliptical cross-section of the tool lumen.

[0196] According to some embodiments of the present invention, the plurality of rods are configured to move apart from one another, thereby expanding a cross-section of the tool lumen and expanding an attached device for delaying production.

[0197] According to some embodiments of the invention, the plurality of rods include a plurality of channels along the plurality of rods for applying adhesive material to a device for delaying production.

[0198] According to some embodiments of the present invention, further comprising a handle connected to at least one of the plurality of rods.

[0199] According to some embodiments of the invention, the control lever is connected to a hub included in the handle.

[0200] According to one aspect of some embodiments of the present invention, there is provided a clamping tool for clamping a cervix, comprising: two jaws for clamping a cervix, a hinge connecting the two jaws so that the jaws can be separated and closed from each other, an extension tool connected to the two jaws, and several controllers for opening and closing the two jaws, wherein the jaws are configured to expand to a width that is greater than 4 times a width of the extension tool.

[0201] According to some embodiments of the invention, the plurality of controllers are configured to move linearly in a direction along an axis of the elongation tool when opening and closing the plurality of jaws.

[0202] According to some embodiments of the invention, each of the two jaws comprises a shape configured to clamp the cervix.

[0203] According to some embodiments of the present invention, the device further comprises a ruler for indicating a distance between the two jaws.

[0204] According to some embodiments of the present invention, the device further comprises a ruler for indicating an angle between the two jaws.

[0205] According to one aspect of some embodiments of the present invention, a method for delaying labor is provided, comprising the steps of: providing an insertion tool and a device for delaying labor connected to a distal end of the insertion tool, inserting the distal end of the insertion device into a vagina, manipulating the insertion tool so that the device surrounds a cervix, separating the device from the insertion tool to leave the device clamping the cervix and withdrawing the insertion tool from the vagina.

[0206] According to some embodiments of the present invention, the insertion tool is an insertion tool as described herein.

[0207] According to some embodiments of the present invention, the device for delaying production is a device for delaying production as described herein.

[0208] According to some embodiments of the present invention, the method further comprises: before inserting the distal end of the insertion tool into the vagina, reducing a cross-section of a lumen of the insertion tool.

[0209] According to some embodiments of the present invention, the inserting includes shrinking a cross-section of the lumen of the insertion tool to pass through an opener.

[0210] According to some embodiments of the present invention, the method further comprises: before manipulating the insertion tool to make the device surround a cervix, expanding the cross-section of the lumen of the insertion tool.

[0211] According to some embodiments of the present invention, further comprising: manipulating the device to clamp the cervix as high as possible on the cervix.

[0212] According to some embodiments of the present invention, providing the insertion tool as described herein when the device described herein is connected to a distal end of the insertion tool further includes: providing a clamping tool as described herein that is inserted through a lumen of the insertion tool.

[0213] According to some embodiments of the present invention, the method further comprises: after inserting the distal end of the insertion tool into the vagina, clamping the cervix with the clamping tool.

[0214] According to some embodiments of the present invention, the method further comprises: clamping the cervix with the clamping tool before inserting the distal end of the insertion tool into the vagina.

[0215] According to some embodiments of the present invention, it further comprises: before the separation of the device from the insertion tool, pulling the cervix with the clamp tool.

[0216] According to some embodiments of the present invention, the method further comprises: before the separation of the device from the insertion tool, pushing the insertion tool so as to push the device up along the cervix.

[0217] Unless otherwise defined, all technical and / or scientific terms used herein have the same meaning as those commonly understood by those of ordinary skill in the art to which the invention belongs. Although methods and materials similar or equivalent to those described herein can be used for the implementation or testing of embodiments of the present invention, exemplary methods and / or materials are described below. In the event of a conflict, this patent specification, including definitions, will dominate. In addition, the materials, methods, and examples are illustrative only and are not intended to be necessarily limiting.

[0218] BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

[0219] Some embodiments of the present invention are described herein by way of example only, with reference to the accompanying drawings. With reference now to the drawings in detail, it should be emphasized that the specific details shown are by way of example and for the purpose of illustrative discussion of embodiments of the present invention. In this regard, the description together with the drawings makes it apparent to those of ordinary skill in the art how several embodiments of the present invention may be implemented.

[0220] In the attached picture:

[0221] Figure 1A and 1B It is a simplified diagram of a production process;

[0222] Figure 2 is a simplified diagram of an apparatus for delaying production according to an exemplary embodiment of the present invention;

[0223] Figure 3 is a simplified cross-sectional illustration of a pregnancy with a device for delaying labor positioned around a cervix according to an exemplary embodiment of the present invention;

[0224] Figure 4A and 4B is a simplified cross-sectional illustration of a device for delaying labor placed around a cervix according to an exemplary embodiment of the present invention;

[0225] Figures 5A to 5C is a simplified diagram of an apparatus for delaying production according to an exemplary embodiment of the present invention;

[0226] Fig. 6A and 6B is a simplified diagram of an apparatus for delaying production according to an exemplary embodiment of the present invention;

[0227] Fig. 7A and 7B are images of several exemplary embodiments of several devices for delaying production according to an exemplary embodiment of the present invention;

[0228] Fig. 8A and 8B is an image of a device for delaying labor placed around a model of a cervix according to an exemplary embodiment of the present invention;

[0229] Figures 9A to 9D is a simplified illustration of several anchoring elements of a device for delaying production according to several exemplary embodiments of the present invention;

[0230] Figures 10A to 10E is a simplified diagram of an apparatus for delaying production according to an exemplary embodiment of the present invention;

[0231] Figures 11A to 11C is a simplified diagram of an apparatus for delaying production according to an exemplary embodiment of the present invention;

[0232] Fig.12 is a simplified flow chart illustration of a method for delaying production according to another exemplary embodiment of the present invention;

[0233] Fig.13A and 13B is a simplified diagram of an apparatus for delaying production according to an exemplary embodiment of the present invention;

[0234] Fig. 13C and 13D is a simplified diagram of an apparatus for delaying production according to an exemplary embodiment of the present invention;

[0235] Figures 13E to 13I is a simplified diagram of an apparatus for delaying production according to an exemplary embodiment of the present invention;

[0236] Figures 13J to 13M is a simplified diagram of an apparatus for delaying production according to an exemplary embodiment of the present invention;

[0237] Fig.14A and 14B is a simplified illustration of a cervical clamping tool according to an exemplary embodiment of the present invention;

[0238] Figures 14C to 14E is a simplified illustration of a cervical clamping tool according to an exemplary embodiment of the present invention;

[0239] Figures 15A to 15D is a simplified illustration of an insertion tool for inserting a device for delaying production according to an exemplary embodiment of the present invention;

[0240] Fig.16A and 16B According to an exemplary embodiment of the present invention, a device for delaying production is prepared. Fig.15A and 15B A simplified illustration of the insertion tool and a clamping tool for clamping a cervix;

[0241] Fig. 16C According to an exemplary embodiment of the present invention, a device for delaying production is placed Fig.15A and 15B The insertion tool and the clamping device for clamping the cervix Fig.16A A simplified illustration of the clamping tool;

[0242] Fig.16D According to an exemplary embodiment of the present invention, a clamping tool pulls a cervix into a device for delaying childbirth. Fig.16A and 16B A simplified illustration of the insertion tool;

[0243] Fig.16E According to an exemplary embodiment of the present invention, a device for delaying production is separated from Fig.16A and 16B A simplified illustration of the insertion tool;

[0244] Fig.16Fis a simplified flow chart of a method for placing a device for delaying labor on a cervix according to an exemplary embodiment of the present invention;

[0245] Figures 17A to 17C is a simplified illustration of a device for delaying labor placed around a cervix according to an exemplary embodiment of the present invention;

[0246] Figures 18A to 18C are several simplified illustrations of a device for delaying labor placed around a cervix when the cervix is ​​under pressure according to an exemplary embodiment of the present invention;

[0247] Fig.18D and 18E is a simplified illustration of a device for delaying labor after inversion on a cervix according to an exemplary embodiment of the present invention;

[0248] Fig.19 is a simplified method for delaying production according to an exemplary embodiment of the present invention; and

[0249] Fig. 20 is a simplified method for delaying production according to an exemplary embodiment of the present invention. DETAILED DESCRIPTION

[0250] The present invention, in some embodiments thereof, relates to devices and methods for delaying premature labor or advancing early delivery, and more particularly, but not exclusively, to devices for insertion into the vagina and around the cervix and associated methods.

[0251] In some embodiments, the device optionally includes a pessary.

[0252] Overview

[0253] One aspect of some embodiments of the present invention relates to a device for encircling a cervix having an anchoring mechanism that increases pressure on the cervix in response to force applied to an upper ring encircling the cervix.

[0254] In some embodiments, a rotational force is generated on anchor elements about a pivot point or line or a pivot element.

[0255] In some embodiments, upon contraction, the upper ring of the device is pushed. This creates a force on the anchoring elements that is redirected as a rotational force about the pivot point / line.

[0256] In some embodiments, upon contraction, the upper ring of the device is pushed. This generates a force directed to the anchoring element, optionally causing the anchoring element to bend inwardly, closing a lumen and clamping the cervix.

[0257] In some embodiments the pivot is a tip of the anchoring element(s) which presses against the external tissue of the cervix. When the pressure of the anchoring element(s) increases, the pressure between the anchoring element(s) and the cervical tissue increases, and a reaction force that holds the upper ring in place increases.

[0258] In some embodiments, the anchoring mechanism optionally comprises a needle that pierces cervical tissue and suturing the device to the cervix.

[0259] In some embodiments, the anchoring mechanism optionally comprises a plurality of pins that pierce the cervical tissue.

[0260] In some embodiments, the device is optionally attached to a cervix using an adhesive, such as silicone or other polymer adhesive or glue or bioadhesive.

[0261] In some embodiments, the adhesive is used to anchor the device.

[0262] In some embodiments, the adhesive helps anchor the device.

[0263] In some embodiments, the device is optionally glued to a cervix using bioadhesive.

[0264] In some embodiments, the bioadhesive is used to anchor the device.

[0265] In some embodiments, the bioadhesive helps anchor the device.

[0266] In some embodiments, the pivoting is around legs designed to surround the cervix, and the feet of the legs designed to anchor to the cervix. Pressing outward and / or downward on the upper ring potentially causes the legs to pivot inward and press against the cervix.

[0267] In some embodiments, the pivoting is around a band around legs designed to surround the cervix, and the feet of the legs designed to anchor to the cervix. Pressing outward and / or downward on the upper ring potentially causes the legs to pivot inward and press against the cervix.

[0268] In some embodiments, the number of legs is three, four, five, six or more.

[0269] In some embodiments, there is equal spacing between all of the plurality of legs.

[0270] In some embodiments, some of the intervals between the legs are of different sizes. By way of non-limiting example, in some embodiments there are six legs, and the intervals at "3 o'clock" and at "9 o'clock" are larger than the other intervals.

[0271] In some embodiments, there are several spaces between the several legs so that some areas of a surface of the cervix are free of compression elements, potentially relaxing blood flow in the cervix, potentially relaxing venous blood flow that is close to a surface of the cervix.

[0272] In some embodiments, the upper ring is constructed to grip the cervix at several sections of a circumference of the cervix, leaving other sections of the circumference of the cervix free of compression elements, potentially relaxing blood flow in the cervix, potentially relaxing venous blood flow that is close to a surface of the cervix.

[0273] In some embodiments, the device is labeled to indicate one or more specific sides of the device, intended to indicate to a physician inserting the device which orientation the device should be inserted and / or which orientation the device should be positioned to clamp the cervix.

[0274] In some embodiments, the device is marked at "12 o'clock" and / or at "6 o'clock." The several marking positions are described in relation to how the physician should view the marking(s) when the device is correctly positioned on the cervix.

[0275] In some embodiments, the device is marked with echogenic, radiopaque or other contrast material to allow detection of the position of the device on the cervix using ultrasound, X-ray, CT, MRI or other medical imaging methods.

[0276] In various embodiments, various different means may be provided, such as, by way of some non-limiting examples:

[0277] Having different radii of said upper ring, optionally a radius ranging from a sharp edge to 3 mm, 5 mm, 7 mm, 10 mm;

[0278] having a different upper ring thickness optionally ranging from 3 to 15 mm;

[0279] Having different shapes of the outer portion of the upper ring, which may be annular or non-annular but other shapes, such as rectangular, oblong, triangular, oval or having several protrusions, which may be evenly or unevenly spaced around the upper ring;

[0280] having different elasticities of said upper ring, optionally ranging from 20 to 90 Shore A;

[0281] Having different hardnesses of the material of the upper ring. In some embodiments the upper ring may be comprised of an inner ring having a higher hardness, by way of non-limiting example, 70 Shore A, and an outer layer of a softer elastomer, by way of non-limiting example, 20 Shore A. In some embodiments the upper ring may also include an inner metal spring covered by a softer material;

[0282] having different radii of a lumen defined by said anchoring element;

[0283] having different radii of a lumen defined between the plurality of anchoring legs;

[0284] With different anchor leg lengths, for example 5 to 40 mm below the upper ring;

[0285] having different widths of the plurality of anchor legs;

[0286] Having different tolerances of said plurality of legs, by way of non-limiting example, 20 Shore A to fully rigid;

[0287] having different elasticities of the plurality of legs; and

[0288] There are different elasticities of an elastic band for pressing the legs toward a cervix.

[0289] In some embodiments, the legs may be rigid and rotatably coupled to the upper ring.

[0290] In some embodiments, the elastic strip has a Shore durometer in a range of 20-90.

[0291] In some embodiments, the element referred to as the elastic strip comprises a metal spring or a metal strip.

[0292] In some embodiments, the elastic strap is attached to the legs of the device.

[0293] In some embodiments, the elastic strap is contained in a sleeve surrounding the legs of the device.

[0294] One aspect of some embodiments of the present invention relates to a device for clamping a cervix, the device having an upper element on a top portion for clamping the cervix and an anchoring element lowered along the cervix.

[0295] One aspect of some embodiments of the present invention relates to a device for clamping a cervix having an anchoring mechanism in which an upper element clamping the cervix is ​​designed to expand under pressure and optionally pivot about a pivot axis or ring or element to release the cervix. Such pivoting can occur in various embodiments shown in the several figures, and in Fig.18A and its description are shown in more detail.

[0296] In some embodiments, the device comprises the upper element and a plurality of legs that descend along the cervix for anchoring to the cervix.

[0297] In some embodiments the device comprises the upper element, legs descending along the cervix for anchoring to the cervix, and a band for pressing the legs against the cervix.

[0298] In some embodiments, the upper element expands under lateral or downward pressure, the legs are anchored to the cervix, and the upper ring flips, pivots or rotates, flipping the device and the legs over the cervix, thereby weakening or releasing the anchoring, allowing the device to slide out of the cervix under the pressure mentioned above.

[0299] In some embodiments, the upper element is in a ring shape.

[0300] In some embodiments, the upper member includes an inner lumen for clamping and applying pressure to specific sections of the cervix and leaving other sections free and pressure-free, potentially at least relaxing blood flow through the free sections.

[0301] In some embodiments, the upper element comprises a plurality of protrusions for pressing against the cervix.

[0302] In some embodiments, the upper element is shaped as an ellipse, a triangle, a rectangle, a pentagon, a hexagon, some other shape with N straight sides, a three-pointed star or an N-pointed star.

[0303] One aspect of some embodiments of the invention relates to a device for encircling a cervix having an upper ring designed to encircle a cervix, legs designed to point downwardly along the cervix, and a band for pressing the legs against the cervix.

[0304] In some embodiments, the strip presses the legs onto the cervix, thereby anchoring the device to the cervix.

[0305] In some embodiments, the device may not have a strap around the legs, and the device is anchored to the cervix without the strap.

[0306] In some embodiments, the upper ring is used to compress the cervix at or below the level of the internal os of the cervix and help prevent the cervix from opening, dilating, and funneling.

[0307] In some embodiments, the strip is used to press the legs against the cervix and help prevent the cervix from opening.

[0308] In some embodiments, the upper ring is used to compress the cervix and help prevent the cervix from opening, and the strap is used to compress the legs against the cervix and help prevent the cervix from opening.

[0309] In some embodiments, the straps are optionally elastic.

[0310] In some embodiments, the device is placed around the cervix, compresses against the cervix and closes the cervix. When a time comes to release the device, for example, when the physician feels it is necessary to release the device prior to term or due to other medical indications, a physician optionally cuts the band, releasing some or all of the pressure of the legs on the cervix.

[0311] In some embodiments, when a time comes to release the device, for example, when the physician feels it is necessary to release the device prior to term or due to other medical indications, a physician optionally shears the ring, releasing some or all of the pressure of the legs on the cervix and enabling removal.

[0312] One aspect of some embodiments of the present invention involves using a tool for insertion through the vagina to clamp a cervix.

[0313] In some embodiments, the cervical clamping tool is optionally inserted through a speculum in the vagina to grasp and clamp a cervix.

[0314] In some embodiments, the cervical clamping tool is optionally used to clamp a cervix and pull the cervix to allow insertion of a device for delaying premature labor and to position the device for delaying premature labor at a higher position on the cervix.

[0315] In some embodiments, the cervical clamping tool optionally includes a scale on which a physician can measure a distance or angle or similar measurement while clamping the cervix, the measurement measuring the degree to which the clamping tool is opened. In some embodiments, the measurement is optionally used to measure a diameter and / or size of the cervix.

[0316] In some embodiments, the scale provides information used when selecting a device for delaying premature labor or early delivery. The information can be provided as an angle at which the jaws are opened; as a distance at which the jaws of the jaws are opened; as a number representing a size of the upper ring of the device for delaying premature labor; or as an arbitrary number.

[0317] In some embodiments, the data is used to select a size of the device for delaying preterm labor or a size of an upper ring of the device for delaying preterm labor.

[0318] In some embodiments, one or both jaws of the jaw tool optionally include wheels that can be used to retract the cervix into the jaws.

[0319] One aspect of some embodiments of the present invention relates to an insertion tool for inserting a device for delaying premature labor or accelerating delivery.

[0320] In some embodiments, the device is coupled to the insertion tool, and the insertion tool is used to insert the device onto a cervix via a vagina.

[0321] In some embodiments, the device is coupled to the insertion tool, and the insertion tool is used to insert the device onto a cervix via a speculum in the vagina.

[0322] In some embodiments, the insertion tool compresses the device so that it presents a smaller cross-section when inserted through the vagina.

[0323] In some embodiments, the insertion tool is configured to cease compression of the device, allowing the device to expand alongside the cervix.

[0324] In some embodiments, the insertion tool comprises two or more parallel rods, and the plurality of parallel rods are configured to be manipulated to slide longitudinally relative to each other. In some embodiments, the insertion tool comprises two, three, four, five, six, seven, eight or more parallel rods.

[0325] In some embodiments, the insertion tool is configured such that a distance between the plurality of parallel rods is changed, compressed or expanded when the plurality of parallel rods are manipulated to slide longitudinally relative to each other.

[0326] In some embodiments, the insertion tool is configured such that when the plurality of parallel rods are manipulated to slide longitudinally relative to each other, the plurality of rods converge more at one end of the lumen than at the other end.

[0327] In some embodiments, the plurality of rods are connected to each other by a plurality of rings. In some embodiments, the plurality of rings are elastic. In some embodiments, the plurality of rings are rigid.

[0328] In some embodiments, the plurality of loops are connected to each other by a plurality of straps or a plurality of links. In some embodiments, the plurality of straps or the plurality of links are elastic. In some embodiments, the plurality of straps or the plurality of links are rigid.

[0329] In some embodiments, an elasticity of the rings / bands / links around the rods allows for variability in the distance or circumference of the distal portions of the rods, and thus potentially allows different rings of different sizes to be attached to the same device.

[0330] In some embodiments, the insertion tool is configured to allow the device to be pushed onto the cervix.

[0331] In some embodiments, the insertion tool is configured to detach from the device once the device has been placed on the cervix.

[0332] In some embodiments, the insertion tool is attached to the device at more than one location.

[0333] In some embodiments, the insertion tool is configured to be detached from the device from more than one location, one or more locations at a time.

[0334] In some embodiments, the insertion tool is configured to detach from the device from all of the attachment locations at once.

[0335] In some embodiments, the insertion tool compresses the device so that it presents a smaller cross-section when inserted through an opening in the vagina.

[0336] According to some embodiments of the present invention, the insertion tool comprises channels along the rods, the channels allowing bioadhesive or adhesive material or silicone to be dispensed into the legs of the device prior to release of the device for delaying labor to allow adhesion to the cervix.

[0337] One aspect of some embodiments of the present invention involves using both a clamping tool and an insertion tool to clamp a cervix and slide a device for delaying or accelerating premature labor onto the cervix.

[0338] In some embodiments, the jaws are used to draw the cervix toward an operator holding the jaws.

[0339] In some embodiments, the clamping tool is used to pull the cervix toward the device.

[0340] In some embodiments, the cervix is ​​held in place and the insertion tool is used to push the device onto the cervix.

[0341] In some embodiments, the cervix is ​​pulled toward an operator, and the insertion tool is used to push the device onto the cervix. In some embodiments, the cervix is ​​pulled toward the operator and the insertion tool is used to push the device onto the cervix at the same time.

[0342] In some embodiments, the cervix is ​​pulled toward the device and the insertion tool is used simultaneously, either simultaneously or in a continuous motion, to push the device, optionally to well position the device in the fornix, around the cervix and on the cervix.

[0343] The words "up", "top" and "upper" in all their grammatical forms are used throughout the specification and claims to describe a direction toward the uterus.

[0344] The words "down", "bottom" and "lower" in all their grammatical forms are used throughout this specification and claims to describe a direction away from the uterus towards the vagina and the outlet of the vagina.

[0345] When the above directions are applied to a device outside the body, the directions "up" and "down" apply to the device as if the device were placed in a body.

[0346] In some embodiments, the device is inserted into a vagina with the upper ring surrounding the cervix, optionally at a level of the vaginal vault, adjacent to the internal cervical os.

[0347] In some embodiments, the device is inserted into a vagina with the upper ring surrounding the cervix and pushed high into the fornix.

[0348] In some embodiments, a method of inserting the device optionally includes surrounding the cervix with the upper ring and then pushing upward on the anchoring mechanism.

[0349] In some embodiments, by limiting cervical dilation, the biological cascade leading to a common pathway of labor characterized by cervical remodeling, cervical ripening, uterine contractility, and fetal membrane activation is slowed or even prevented.

[0350] In some embodiments, when the uterus contracts, pushing the amniotic sac in which the fetus is located toward the cervix and causing funneling, the ring redirects a force generated to apply a closing force on the internal os of the cervix and potentially reduce funneling.

[0351] In some embodiments, by applying the closing force to the cervix in response to the contraction, the biological cascade leading to a common pathway of labor characterized by cervical remodeling, cervical ripening, uterine contractions, and activation of fetal membranes is slowed or even prevented.

[0352] In some embodiments, the ring is designed to provide a gradual; linear; a decreasing or a fixed force to close the internal os of the cervix when the uterus contracts.

[0353] An aspect of some embodiments of the present invention includes providing an anchoring mechanism for the device, wherein the anchoring mechanism is configured to increase the grip of the anchoring extension on a surface of the patient's body.

[0354] In some embodiments, the anchoring mechanism may include a plurality of protrusions for increasing the friction between the anchoring mechanism and a surface of a cervix on which the device is placed.

[0355] In some embodiments, the anchoring mechanism may include an adhesive element, such as silicone or other polymer adhesive or glue, for increasing the friction between the anchoring mechanism and a surface of a cervix on which the device is placed.

[0356] In some embodiments, the anchoring mechanism may include a bioadhesive.

[0357] In some embodiments, the anchoring mechanism may be anchored or partially anchored by friction against the vaginal wall.

[0358] One aspect of some embodiments of the invention involves anchoring a device to a lower portion of a cervix, with a top portion of the device narrowing the cervical opening.

[0359] In some embodiments, the device comprises a lumen that surrounds the cervix.

[0360] In some embodiments, a length of the lumen of the device is approximately equal to a length of the cervix. In some embodiments, a length of the lumen of the device is less than a length of the cervix.

[0361] In some embodiments, an upper ring in the device is designed to be smooth so that when the baby's head applies force, the force is distributed and does not apply concentrated force to any specific location on the cervix, potentially preventing tearing.

[0362] Some potential benefits of using an anchoring mechanism include:

[0363] In some embodiments, no sutures are required, and the device is easily and simply deployed, potentially without anesthesia, and potentially in an outpatient or clinical procedure.

[0364] In some embodiments, sutures are optionally used, but fewer sutures may be required, potentially resulting in a simpler surgery, potentially not requiring a general anesthesia, potentially resulting in less trauma to the sutured organ, and potentially resulting in better device retention.

[0365] In some embodiments, automated suturing is optionally used, potentially resulting in a simpler procedure, potentially without the need for general anesthesia, potentially resulting in less trauma to the sutured organ, and potentially resulting in better device retention.

[0366] In some embodiments, the device is a disposable device that is placed in the vagina, around the cervix.

[0367] In some embodiments, the device is positioned by a physician in an office setting.

[0368] In some embodiments, the device is positioned by a physician in a hospital.

[0369] In some embodiments, the device is positioned by a physician in a procedure lasting several minutes.

[0370] In some embodiments, the device is removed by a physician during delivery.

[0371] In some embodiments, the device is removed prior to delivery, during delivery, or when deemed necessary by a physician.

[0372] In some embodiments, the device is removed by a physician in a procedure lasting several minutes.

[0373] In some embodiments, the device optionally measures and collects data related to the contractions and dilation of the cervix and the progress of labor.

[0374] In some embodiments, the device may optionally transmit the data to an external receiver via wireless communication, such as Bluetooth technology or other wireless technology.

[0375] In some embodiments, the device optionally includes a contraction sensing element, such as, by way of non-limiting example, a strain gauge. In some embodiments, the device optionally includes a signal amplifier for amplifying the signal from the contraction sensing element.

[0376] In some embodiments, the device optionally transmits a contraction signal to an external receiver via radio frequency (RF).

[0377] In some embodiments, the RF communication device includes a Bluetooth transmitter and optionally transmits a contraction signal to an external Bluetooth receiver (not shown). In some embodiments, the external Bluetooth receiver (not shown) can be included in a device, such as a smartphone, for real-time contraction monitoring by the physician and / or the patient.

[0378] In some embodiments, the device optionally includes a memory for storing the measurements.

[0379] In some embodiments, the device optionally includes a contraction sensing element, such as, by way of non-limiting example, a strain gauge. In some embodiments, the device optionally includes a signal amplifier for amplifying the signal from the contraction sensing element.

[0380] In some embodiments, the device is drug eluting, optionally eluting a drug for delaying or advancing labor.

[0381] In some embodiments, the device optionally collects data related to preterm birth.

[0382] In some embodiments, the device optionally collects data related to the condition of the fetus.

[0383] In some embodiments, one or more of the several benefits described above may potentially be achieved.

[0384] Before explaining at least one embodiment of the invention in detail, it should be understood that the invention is not necessarily limited in its application to the details of construction and arrangement of the elements and / or methods set forth in the following description and / or illustrated in the drawings and / or examples. The invention is capable of other embodiments or being practiced or implemented in various ways.

[0385] Reference now Figures 1A to 1B , Figures 1A to 1B This is a simplified diagram of a production process.

[0386] A major function of a cervix 102 is its role in childbirth. As a fetus 104 descends in preparation for birth, a presenting part, usually the head 106, rests on and is supported by the cervix 102. The fetus 104 is surrounded by amniotic fluid 105 in an amniotic sac. This stage is depicted in FIG. Figure 1A middle.

[0387] When the cervix 102 begins to dilate, the support begins to give way. Figure 1B Drawing.

[0388] During childbirth, when the fetal head 106 or fetal buttocks are pushed from the uterus 103 to the vagina 101, the cervix 102 must dilate to a diameter larger than the fetal head 106 or fetal buttocks: the exact size depends on gestational age.

[0389] As delivery approaches, the cervix 102 also becomes shorter, a process called attenuation.

[0390] Reference now Figure 2 , Figure 2 is a simplified diagram of an apparatus for delaying production according to an exemplary embodiment of the present invention.

[0391] Figure 2 A device 200 is shown, comprising a device 200 for surrounding a cervix, an anchoring mechanism 203 for anchoring the device on the cervix.

[0392] In some embodiments, the upper ring 201 is made of polysiloxane. In some embodiments, the upper ring 201 comprises a polysiloxane tube.

[0393] Figure 2 Also shown is a strap 202 surrounding the device 200. In some embodiments, the strap 202 is elastic. In some embodiments, the strap 202 is rigid.

[0394] In some embodiments, the anchoring mechanism 203 converts the force on the upper ring into an inward radial force on the anchoring mechanism 203 .

[0395] In some embodiments, a downward force on the upper ring 201 is redirected as an inward rotational force on the anchoring mechanism 203, with an inner tip of the anchoring mechanism (the inner tip contacts an outer surface of a cervix) acting as a hinge at one or more points or along a line.

[0396] In some embodiments, the device 200 is a single-use device that is placed in a vagina around the cervix and is removed after a single use.

[0397] In some embodiments, the device 200 is elastic and configured to be compressed longitudinally, ie, in a top-bottom direction.

[0398] In some embodiments, the device 200 is flexible and configured to be elongated longitudinally, ie, in a top to bottom direction.

[0399] In some embodiments, the device 200 may be elongated longitudinally, ie, in a top to bottom direction.

[0400] In some embodiments, the device 200 is elastic and configured to be compressed laterally, ie, in a direction that reduces diameter.

[0401] In some embodiments, the device 200 is elastic and configured to be expanded laterally, ie, in a direction of increasing diameter.

[0402] Reference now Figure 3 , Figure 3 is a simplified cross-sectional illustration of a pregnancy with a device for delaying labor positioned about a cervix according to an exemplary embodiment of the present invention.

[0403] Figure 3 A fetus 301 is shown in a uterus 302. The head 303 of the fetus 301 is located on an upper opening 306 of the cervix 304, called the internal os. A device 305 for delaying labor surrounds the cervix, optionally on a lower opening 307 of the cervix 304, called the external os.

[0404] In some embodiments, the device 305 acts as an elastic protection mechanism to help keep the cervix closed before delivery, helping to prevent or delay premature delivery.

[0405] In some embodiments, the device 305 is configured to allow temporary shortening of the cervix during contraction.

[0406] Reference now Figure 4A and 4B , Figure 4A and 4B is a simplified cross-sectional illustration of a device for delaying labor placed about a cervix according to an exemplary embodiment of the present invention.

[0407] Figure 4A and 4B The device 400 is shown having an upper ring 401 for surrounding a cervix 404 , and an anchoring mechanism 403 for anchoring the device 400 to the cervix 404 .

[0408] In some embodiments, the anchoring mechanism 403 redirects or converts the force on the upper ring 401 into an inward radial force 409 on the anchoring mechanism 403 .

[0409] In some embodiments, the anchoring mechanism 403 includes a plurality of arms.

[0410] Figure 4A and 4B Also shown is an optional band 402 surrounding the device 400, optionally preventing elements of the anchoring mechanism 403 of the device 400 from expanding radially outward.

[0411] Figure 4A and 4B The approximate locations of an internal os 406 of the cervix 404 and an external os 407 of the cervix 404 are also shown.

[0412] In some embodiments, when the fetal head or the amniotic sac presses down on the upper ring 401 , an anchoring effect of the anchoring mechanism 403 on the cervix 404 prevents the device 400 from sliding down along the cervix 404 .

[0413] In some embodiments, in response to a downward force on the upper ring 401 , a tip or tips 408 of the anchoring mechanism 403 optionally act as a hinge, causing the anchoring mechanism 403 to push radially inward, exerting force on the cervix 404 .

[0414] In some embodiments, in response to a downward force on the upper ring 401 , the strip 402 optionally acts as a hinge, causing the anchoring elements 403 to push radially inward, exerting force on the cervix 404 .

[0415] In some embodiments, in response to an outward force on the upper ring 401 , the strip 402 optionally acts as a hinge, causing the anchoring elements 403 to push radially inward, exerting force on the cervix 404 .

[0416] In some embodiments, the upper ring 401 includes a spring that responds to the opening force on the upper ring 401 and applies a force to expand the upper ring 401, causing the anchoring elements 403 to be pushed radially inward, exerting force on the cervix 404.

[0417] Reference now Figures 5A to 5C , Figures 5A to 5C is a simplified diagram of an apparatus for delaying production according to an exemplary embodiment of the present invention.

[0418] Figure 5A is a top view of a device 500 for delaying production, Figure 5B is a side view of the device 500 and Figure 5C is a bottom view of the device 500 .

[0419] refer to Figures 5A to 5C , the term top view means a view in a direction from a uterus to a vagina, and the term bottom view means the opposite direction.

[0420] Figures 5A to 5C The device 500 is shown to include an upper ring 501 and a plurality of anchoring elements 503 for anchoring the device 500 on the cervix.

[0421] Figures 5A to 5C An optional strip 502 is also shown for optionally preventing the plurality of anchoring elements 503 of the device 500 from expanding radially outward.

[0422] The number of anchoring elements 503 included in an anchoring mechanism of the device 500 may range from a small number, even one or two, to a large number, for example 20 and more.

[0423] In some embodiments, the number of anchoring elements is an even number, within the inclusive range of two to twenty.

[0424] In some embodiments, the number of anchoring elements is an odd number, within the range of three to twenty-one inclusive.

[0425] In some embodiments, the plurality of anchoring elements are evenly spaced about a lumen defined by the upper ring.

[0426] In some embodiments, the plurality of anchoring elements are unevenly spaced about a lumen defined by the upper ring.

[0427] In some embodiments, the strap 502 is elastic.

[0428] In some embodiments, the strap 502 is rigid. In some embodiments, the strap 502 is semi-rigid.

[0429] In some embodiments, the strap 502 includes a spring.

[0430] The device 500 may optionally be constructed in different sizes, diameters, and heights.

[0431] Depending on the size of a patient, the intended patient (human or animal), and the medical condition, a typical diameter of the device is optionally 32 millimeters (mm), ranging from small, such as 10 mm or 20 mm, to larger, such as 40 mm, 50 mm, 60 mm and larger.

[0432] Reference now Fig. 6A and 6B , Fig. 6A and 6B is a simplified diagram of an apparatus for delaying production according to an exemplary embodiment of the present invention.

[0433] Fig. 6A is an isometric top view of an apparatus 600 for delaying production, and Figure 6B is a top view of the device 600 .

[0434] refer to Fig. 6A and 6B , the term top view means a view in the direction from a uterus to an outlet of a vagina, and the term bottom view means the opposite direction.

[0435] Fig. 6A and 6B The device 600 is shown to include an upper ring 601 and a plurality of anchoring elements 603 for anchoring the device 600 to the cervix.

[0436] Fig. 6A and 6B Also shown is an optional strap 602 for optionally preventing elements of the anchoring mechanism 603 of the device 600 from expanding radially outward.

[0437] In some embodiments, the upper ring 601 includes a spring 609. In some embodiments, the upper ring 601 includes an elastic tube surrounding the spring 609.

[0438] Reference now Fig. 7A and 7B , Fig. 7A and 7B are images of several exemplary embodiments of devices for delaying production according to an exemplary embodiment of the present invention.

[0439] Fig. 7A and 7B is a top view of a device 700 for delaying production.

[0440] refer to Fig. 7A and 7B , the term top view means a view from a direction of a uterus toward a vagina.

[0441] Fig. 7A and 7B The device 700 is shown to include an upper ring 701 and a plurality of anchoring elements 703 for anchoring the device 700 to the cervix.

[0442] Fig. 7A and 7B This is intended to illustrate that the spacing between the plurality of anchoring elements 703 used to anchor the device 700 on the cervix may be different in different embodiments.

[0443] Reference now Fig. 8A and 8B , Fig. 8A and 8B is an image of a device for delaying labor placed around a model of a cervix according to an exemplary embodiment of the present invention.

[0444] Fig. 8A and 8B A laboratory model 804 is shown with a device 800 surrounding or hugging a cervix.

[0445] Fig. 8A and 8B is an isometric view of the apparatus 800 and the laboratory model 804 of the cervix.

[0446] Fig. 8A and 8B is shown upside down relative to the previous several figures, with "top" pointing downward and "bottom" pointing upward.

[0447] Fig. 8A and 8B The device 800 is shown including an upper ring 801, anchoring elements 803, and an optional strip 802 for optionally preventing elements of an anchoring mechanism of the device 800 from expanding radially outward.

[0448] Reference now Figures 9A to 9D , Figures 9A to 9D is a simplified illustration of several anchoring elements of a device for delaying production according to several exemplary embodiments of the present invention.

[0449] Figures 9A to 9D Several different embodiments of different anchoring elements 900 , 910 , 920 , 930 are shown.

[0450] The anchoring elements 900, 910, 920, 930 include a top side configured to fit over an upper ring (not shown). Figures 9A to 9D A shape (in the figure but shown in previous figures).

[0451] Shown in Figures 9A to 9D Each of the plurality of anchoring elements 900, 910, 920, 930 in the drawings exhibits a different anchoring element foot 903, 913, 923, 933 designed to provide anchoring to a surface of a cervix (not shown).

[0452] Fig. 9A The anchoring element foot 903 is shown having a single rectangular protrusion facing one side of the cervix.

[0453] Fig. 9B The anchoring element foot 913 is shown having a rounded protrusion toward a cervical side.

[0454] Fig. 9C The anchoring element foot 903 is shown having two rectangular protrusions facing one side of the cervix.

[0455] Fig.9D The anchoring element foot 903 is shown having a single hemispherical protrusion facing toward a cervical side, with the rounded side of the hemisphere facing toward a cervical side.

[0456] In some embodiments (not shown), the anchoring element comprises one or more pins for penetrating a distance into the cervix. A length of the pin(s) is optionally in a range between 0.5 mm and 5 mm.

[0457] In some embodiments, the projections of the anchoring elements are designed to anchor to an interior lumen of the device against an outer surface of the cervix.

[0458] In some embodiments, a shape of the anchoring element designed to rest against an internal lumen of the device against the outer surface of the cervix is ​​optionally designed to adhere with a bioadhesive and / or an adhesive, such as silicone or other polymer adhesive or glue.

[0459] In some embodiments, a shape of the anchoring element designed to rest against an internal lumen of the device, against the outer surface of the cervix is ​​optionally designed for friction, by way of non-limiting example, by having multiple protrusions, by having a rough surface, and so forth.

[0460] In some embodiments, a shape of the anchoring element designed to rest against a surface of the vagina is optionally designed for friction, by way of non-limiting example, by having multiple protrusions, by including a plurality of pins, by being suitable for gluing, by using an adhesive, such as silicone or other polymer adhesive or glue, by having a rough surface, and the like.

[0461] Reference now Figures 10A to 10E , Figures 10A to 10E is a simplified diagram of an apparatus for delaying production according to an exemplary embodiment of the present invention.

[0462] Fig. 10A A device 1000 is shown, comprising an upper ring 1001 and a plurality of anchoring elements 1003 .

[0463] Fig. 10A It is an isometric top view and reference Fig. 10A , the term top view means a view in a direction from a uterus toward a vagina.

[0464] Fig. 10A Also shown is an optional strip 1002 that surrounds the device 1000 and optionally prevents several elements of the anchoring mechanism 1003 of the device 1000 from expanding radially outward.

[0465] Fig. 10AThe present invention is intended to illustrate an exemplary embodiment of an anchoring element (several) 1003, wherein the anchoring element 1003 includes a plurality of slots 1004 for optionally allowing a needle and / or suture (not shown in FIG. Fig. 10A ) through.

[0466] Fig. 10B is with Fig. 10A Isometric bottom view from the opposite direction.

[0467] Fig. 10B The device 1000 is shown with additional detail on the number of anchoring elements 1003 .

[0468] Fig. 10B A view of the internal components of the anchoring components 1003 and a suture needle 1005 stored therein is shown.

[0469] In some embodiments, the suture needle 1005 is optionally pushed through one of the plurality of slots 1004 to penetrate cervical tissue, potentially assisting in anchoring the device 1000 .

[0470] In some embodiments, the suture needle 1005 is optionally squeezed through one of the several slots 1004, penetrating the cervical tissue, and a tip of the suture needle 1005 returns into another one of the several slots 1004, potentially assisting in anchoring the device 1000 and / or covering the sharp tip of the suture needle 1005.

[0471] In some embodiments, the pushing of the suture needle 1005 through a slot 1004 is optionally performed by a tool, optionally performed by a caregiver operating the tool.

[0472] In some embodiments, the suturing needle 1005 is optionally packaged with a mechanism in the anchoring element 1003 that, when activated and / or released and / or triggered, activates the suturing needle 1005 through the cervical tissue.

[0473] Fig. 10C The device 1000 is shown, including the upper ring 1001 and the plurality of anchoring elements 1003 .

[0474] Fig. 10C Similar to Fig. 10A , which is an isometric top view.

[0475] Fig. 10C The optional strip 1002 is also shown.

[0476] Fig. 10CIt is intended to illustrate the exemplary embodiment of the anchoring element(s) 1003 , and to illustrate the passage of the suture needle 1005 through a first slot 1004 and the return of a tip of the suture needle 1005 through a second slot 1004 .

[0477] Fig. 10D The device 1000 is shown with additional detail of the number of anchoring elements 1003 .

[0478] Fig. 10D is an isometric bottom view. Fig. 10C in the opposite direction.

[0479] Fig. 10D Several internal components of the several anchoring elements 1003 and a view of the suture needle 1005 are shown.

[0480] Fig. 10D An exemplary embodiment is shown in which a tip of the suture needle 1005 passes through the first slot 1004 and returns through the second slot 1004 .

[0481] Fig. 10E A view showing the internal components of the anchoring components 1003 and the suture needles 1005 stored therein.

[0482] In some embodiments, the suturing needle 1005 is optionally activated by a mechanism 1007 that rotates the suturing needle 1005 to suturing cervical tissue.

[0483] In some embodiments, the suturing needle 1005 is optionally activated by releasing a stopper 1009, which optionally blocks the movement of the suturing needle 1005 until activation. In some embodiments, the stopper 1009 is activated to release the suturing needle 1005 by pressing a spring 1008.

[0484] Fig. 10E An exemplary embodiment is shown in which a spring 1006 is included in the upper ring 1001 .

[0485] Now refer to 11A to 11C, Figures 11A to 11C is a simplified diagram of an apparatus for delaying production according to an exemplary embodiment of the present invention.

[0486] Figures 11A to 11C It is a bottom view of a device 1100 for delaying production.

[0487] refer to Figures 11A to 11C , the term bottom view means a view in a direction from a vagina toward a uterus.

[0488] Figures 11A to 11C The device 1100 is shown to include an upper ring 1101 , a plurality of anchoring elements 1103 , and an optional strap 1102 .

[0489] Fig.11A The device 1100 is shown having a first diameter R1.

[0490] Fig. 11B The devices 1100 are shown to have the same first diameter R1. Fig. 11B It is a more simplified view showing the anchoring elements 1103 and a ring 1105 (present in the figure, not necessarily in the device 1100) which emphasizes the first diameter R1.

[0491] Fig. 11C The device 1100 is shown after being compressed to a second diameter R2. Fig. 11C The anchoring elements 1103 are shown along with a smaller annular ring 1105B (present in the figure, not necessarily in the device 1100) that emphasizes the second diameter R2. Fig. 11C An exemplary second diameter R2 is shown that is smaller than the first diameter R1.

[0492] It should be noted that the device 1100 may optionally be expanded to have a diameter (not shown) that is greater than the first diameter R1.

[0493] Reference now Fig.12 , Fig.12 is a simplified flow chart illustration of a method for delaying production according to another exemplary embodiment of the present invention.

[0494] Fig.12 The method comprises the steps of:

[0495] A device for delaying childbirth is provided, wherein the device forms a lumen (1202) for surrounding the cervix; the device is placed in the vagina so that the lumen surrounds the cervix (1204);

[0496] Positioning the device so that the upper ring surrounds the cervix in the fornix and at a level adjacent to the internal os of the cervix (1206); and

[0497] The device is positioned so that the anchoring element clamps the cervix (1208).

[0498] In some embodiments, the apparatus comprises:

[0499] an upper ring for surrounding the cervix; and

[0500] An anchoring mechanism is used to anchor the device to the cervix.

[0501] In some embodiments, the device includes an optional strap that optionally prevents the plurality of elements of the anchoring mechanism from expanding radially outward.

[0502] In some embodiments, the method includes compressing the device to pass through a vaginal opening.

[0503] In some embodiments, the method includes releasing compression of the device to assist in surrounding the cervix with the device.

[0504] In some embodiments, positioning the device includes actuating or pushing the device upwardly so that the upper ring surrounds the cervix in the fornix and at a level adjacent to the internal os of the cervix.

[0505] In some embodiments, the method includes expanding the device to assist in surrounding the cervix.

[0506] In some embodiments, the method includes releasing the expansion of the device.

[0507] In some embodiments, the method includes clamping the cervix by pressing the anchoring mechanism against the cervix.

[0508] In some embodiments, the anchoring means comprises an adhesive, such as silicone, some other polymer adhesive, glue.

[0509] In some embodiments, the method includes anchoring the anchoring mechanism to the cervix by inserting at least one pin into the cervix.

[0510] In some embodiments, the method includes positioning a needle through the cervical tissue using the anchoring mechanism.

[0511] In some embodiments, the method comprises suturing at least one of the anchoring elements to the cervix.

[0512] Reference now Fig.13A and 13B , Fig.13A and 13B is a simplified diagram of an apparatus for delaying production according to an exemplary embodiment of the present invention.

[0513] Fig.13A and 13BA device for delaying labor is shown, the device comprising an upper ring 1301 for surrounding a cervix, connectors 1304 for connecting the upper ring to anchor pads 1303, a spring 1305, a strap 1306 and protrusions 1302.

[0514] In some embodiments, the spring 1305 is used to push open the upper ring 1301 and the plurality of anchor pads 1303 and / or the strip 1306 .

[0515] In some embodiments, when the device is inserted into a vagina and positioned to surround a cervix, the spring 1305 is held compressed, and optionally released as the plurality of anchor pads 1303 clamp the cervix, optionally as high as possible along the cervix.

[0516] In some embodiments, as the spring 1305 is released, the upper ring 1301 is pushed toward a top of the cervix against the anchoring of the plurality of anchor pads 1303 .

[0517] Reference now Fig. 13C and 13D , Fig. 13C and 13D is a simplified diagram of an apparatus for delaying production according to an exemplary embodiment of the present invention.

[0518] Fig. 13C and 13D A device for delaying labor is shown, the device comprising an upper ring 1311 for surrounding a cervix, a plurality of anchoring rings 1313, 1314, a plurality of anchoring prongs 1317 and a spring 1316.

[0519] In some embodiments, the spring 1316 is used to push the upper ring 1311 and the plurality of anchor rings 1313 , 1314 apart.

[0520] In some embodiments, the spring 1316 is held compressed when the device is inserted into a vagina and positioned to encircle a cervix, and is optionally released when the plurality of anchoring rings 1313 clamp the cervix, optionally as high as possible along the cervix.

[0521] In some embodiments, as the spring 1316 is released, the upper ring 1311 is pushed toward a top of the cervix against the anchoring of the plurality of anchoring rings 1313, 1314.

[0522] Reference now Figures 13E to 13I , Figures 13E to 13Iis a simplified diagram of an apparatus for delaying production according to an exemplary embodiment of the present invention.

[0523] Figures 13E to 13I A device is shown, the device comprising an upper ring 1321 for surrounding a cervix, and an anchoring mechanism for anchoring the device on the cervix. The anchoring mechanism comprises a plurality of legs 1323 for pressing against a cervix and clamping the cervix, a plurality of feet 1325, and a band 1324 for pressing the plurality of feet against the cervix.

[0524] Fig.13E It is an isometric top view. Fig.13F This is an isometric bottom view. Figure 13G It is a top view. Fig.13H It is a top view and Fig.13I It is a side view.

[0525] In some embodiments, one or more of the plurality of feet 1325 include an optional plate 1326 for stiffening the plurality of feet 1325 .

[0526] In some embodiments, one or more of the plurality of feet 1325 include an optional hole 1327 for connection to an insertion tool, in some embodiments, for connection to a connection tool as described herein.

[0527] In some embodiments, the spacing between the plurality of feet 1325 includes some spacing between the plurality of feet 1325 that are greater than other spacing between the plurality of feet 1325 .

[0528] In some embodiments, the larger spacing is located, by way of non-limiting example, such as indicated by number of arrows 1322 .

[0529] In some embodiments, the larger intervals are, by way of non-limiting example, at "3 o'clock" and "9 o'clock".

[0530] In some embodiments, the device includes markings to potentially guide a physician to a desired orientation for placement of the device on the cervix.

[0531] In some embodiments, the marks are, by way of non-limiting example, located at “12 o’clock” and “6 o’clock,” at positions indicated by arrows 1328 .

[0532] exist Figures 13E to 13I The embodiments shown in the embodiment can be optionally combined with reference Figure 2 and 5ASeveral embodiments shown and described in connection with FIG. 5C share features.

[0533] Reference now Figures 13J to 13M , Figures 13J to 13M is a simplified diagram of an apparatus for delaying production according to an exemplary embodiment of the present invention.

[0534] Figures 13J to 13M A device is shown, the device comprising an upper ring 1331 for surrounding a cervix, and an anchoring mechanism for anchoring the device to the cervix. The anchoring mechanism comprises a plurality of legs 1333, a plurality of feet 1335 for pressing against a cervix and clamping the cervix, and a band 1334 for pressing the plurality of feet against the cervix.

[0535] Fig.13J is an isometric view. Figure 13K It is a top view. Figure 13L It is a top view and Figure 13M It is a side view.

[0536] In some embodiments, one or more of the plurality of feet 1335 include an optional plate 1336 to stiffen the plurality of feet 1335 .

[0537] In some embodiments, one or more of the plurality of feet 1335 include an optional hole 1337 for connection to an insertion tool, and in some embodiments, for connection to a connection tool as described elsewhere herein.

[0538] In some embodiments, the upper ring 1331 is constructed to grasp a cervix (not shown) at several sections of a circumference of the cervix, leaving other sections of the circumference of the cervix free of compression elements, potentially relaxing blood flow in the cervix, potentially relaxing venous blood flow that is close to a surface of the cervix.

[0539] Figures 13J to 13M A non-limiting example embodiment is shown in which a plurality of protrusions 1332 optionally protrude into a lumen or space in the upper ring 1331. In some embodiments, the number of protrusions may be 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 or even greater.

[0540] In some embodiments, the upper ring 1331 is not necessarily a ring, but can be referred to as an upper element 1331. The upper element 1331 defines an internal lumen for clamping and pressing against specific sections of the cervix, and leaving other sections free, without pressure, potentially relaxing blood flow through at least the free sections.

[0541] In some embodiments, the upper element 1331 includes a plurality of protrusions, such as a plurality of projections 1332 for pressing against the cervix.

[0542] In some embodiments, the upper element 1331 is shaped as an oval (not shown), a triangle (not shown), a rectangle (not shown), a pentagon (not shown), a hexagon (not shown), some other shape with N straight sides (not shown), a triangular star (not shown) or an N-pointed star (not shown).

[0543] exist Figures 13J to 13M The embodiments shown in the reference Figures 13E to 13I , Figure 2 and Figures 5A to 5C The several embodiments shown and described share several features.

[0544] Reference now Fig.14A and 14B , Fig.14A and 14B is a simplified illustration of a cervical clamping tool according to an exemplary embodiment of the present invention.

[0545] Fig.14A and 14B A tool 1400 for clamping a cervix is ​​shown, the tool comprising two jaws 1411 , 1412 and a hub 1410 connecting the two jaws 1411 , 1412 .

[0546] Fig.14A showing the tool 1400 in a jaw closed position, and Fig. 14B The tool 1400 is shown in a jaw open position.

[0547] In some embodiments, the clamping tool 1400 optionally includes a plurality of additional hubs 1409a, 1409b connected by a hub 1402 to a plurality of extension handles 1406, 1407. The optional extension handles 1406, 1407 potentially allow the tool 1400 to be used further away from the cervix to be clamped. The optional extension handles 1406, 1407 optionally allow the tool 1400 to be used further away from a vagina where the tool is inserted to clamp the cervix.

[0548] In some embodiments, the tool 1400 optionally includes a ruler 1408. The ruler optionally indicates a degree of opening of the plurality of jaws 1411, 1412. In various embodiments, the ruler indicates the degree of opening of the plurality of jaws 1411, 1412 by one or more of the following: indicating a distance, indicating an angle, indicating a corresponding size for a suitable device for a device for delaying production, indicating a corresponding size of one or more elements for a suitable device for a device for delaying production, and indicating an arbitrary number, optionally for selecting a suitable device for a device for delaying production.

[0549] In some embodiments, the tool 1400 optionally includes a spring for pushing the plurality of extension handles 1406, 1407 apart, and a release lever 1404. In some embodiments, the release lever 1404 optionally acts on a tooth rack 1408 (where the pin 1405 is an optional end of a travel stop), releasing the plurality of extension handles 1406, 1407 to separate, and the plurality of jaws 1411, 1412 to open.

[0550] In some embodiments, the control rod 1404 is selectively slid forward or backward to operate the plurality of jaws 1411 , 1412 .

[0551] Reference now Figures 14C to 14E , Figures 14C to 14E is a simplified illustration of a cervical clamping tool according to an exemplary embodiment of the present invention.

[0552] Fig. 14C and 14D A tool 1420 for clamping the cervix is ​​shown, the tool comprising two jaws 1428 , 1429 , a hub 1427 connecting the two jaws 1428 , 1429 , an extension tube 1424 , and one or more controllers 1422 , 1423 , 1425 .

[0553] Fig.14E The tool 1420 is shown without the extension tube 1424 so as to expose several internal parts of the tool 1420.

[0554] Fig. 14C and 14E showing the tool 1420 in a jaw closed position, and Fig.14D The tool 1420 is shown in a jaw open position.

[0555] A first control, optionally a button 1425 is optionally used to open and close the plurality of jaws 1428, 1429 by pushing a rod 1430 into the tube 1424 (open) or pulling the rod out of the tube 1424 (close).

[0556] In some embodiments, the tool 1420 optionally includes a spring (not shown) that pushes the rod 1430 out of the tube 1424, the rod 1430 optionally pushes against the spring to open the plurality of jaws 1428, 1429, and the rod 1430 is released to close the plurality of jaws 1428, 1429.

[0557] In some embodiments, the tool 1420 optionally includes a handle 1423 for use when the button 1425 is pressed.

[0558] In some embodiments, the tool 1420 optionally includes a latch 1422, optionally used against a ratchet 1421, for locking and / or releasing the rod 1430 to move along the tube 1424, and opening and / or closing the plurality of jaws 1428, 1429.

[0559] Fig. 14C A non-limiting example of a rod 1430 is shown, wherein several segments are connected by several hinges 1432. In some embodiments, the tool can be bent to enter a body through the vagina and clamp a cervix. In some embodiments, the tube 1424 can be flexible.

[0560] Reference now Figures 15A to 15D , Figures 15A to 15D is a simplified illustration of an insertion tool for inserting a device for delaying production according to an exemplary embodiment of the present invention.

[0561] Figures 15A to 15D An insertion tool 1500 is shown for inserting a device 1502 for delaying production.

[0562] Fig.15A and 15B The device 1502 for delaying production is shown mounted to a distal end of the insertion tool 1500.

[0563] The insertion tool 1500 includes a plurality of rods 1504 and a plurality of rings 1503 to which the plurality of rods 1504 are connected, forming a shape of a lumen surrounded by the plurality of rods 1504 .

[0564] The device 1502 may optionally be coupled to a distal end of the plurality of rods 1504 .

[0565] In some embodiments, the device 1502 can optionally be inserted into a vagina (not shown) while coupled to the distal end of the insertion tool 1500, and optionally manipulated to surround and clamp a cervix (not shown).

[0566] The shape of the lumen surrounded by the plurality of rods 1504 can optionally be changed by longitudinally moving some of the plurality of rods 1504 relative to the other plurality of rods 1504, for example, as shown in Fig. 15B In such a case, the distance between the plurality of rods 1504 is optionally reduced, at least across a dimension of a cross section of the lumen, to form a narrower lumen. In such a case, the insertion tool, with or without the device 1502 attached, can potentially more easily pass through a vagina and / or a speculum (not shown), and / or potentially reduce the dilation of the vagina required to insert the device 1502 using the insertion tool 1500.

[0567] In some embodiments, the shape of the lumen surrounded by the plurality of rods 1504 is optionally transformed from a circle to an ellipse.

[0568] In some embodiments, the shape of the lumen surrounded by the plurality of rods 1504 is optionally transformed from an ellipse to another ellipse having a different length of a minor axis of the ellipse or a different length of a major axis of the ellipse.

[0569] In some embodiments, the insertion tool includes one or more of the following:

[0570] a plurality of cups 1514 or a plurality of pins for pushing the device 1502 from the distal ends of the plurality of rods 1504;

[0571] A mechanism located at a proximal end of the plurality of rods 1504 is used to optionally detach the device 1502 from the plurality of distal ends of the plurality of rods 1504 . Fig.15A and 15B The mechanism for detaching the device 1502 is shown to include a handle 1508 and / or a button 1509. In some embodiments, the device 1502 is optionally detached from the distal end of a rod 1504 by pulling the handle 1508 at the proximal end of the rod 1504.

[0572] In some embodiments, an optional button 1509 allows fine adjustment of a position of the device in the fornix. For example, by pressing each of the several buttons 1509 separately, the several rods each push the device in a different position, potentially allowing placement in the fornix completely around the cervix,

[0573] an optional clamp 1507 for the insertion tool 1500, and

[0574] An optional control rod 1506 having a hinge 1513 which, when squeezed, longitudinally moves the rods 1504 and changes a cross-sectional shape of the lumen formed by the rods 1504 .

[0575] Fig. 15C When the button 1508 is optionally pulled back, the cup 1514 or pin is optionally pulled back along the plurality of rods 1504, releasing the means for attaching the device 1502 (not shown). Fig. 15C A distal end of the several rods described in (in).

[0576] Fig.15D As the handle 1508 is optionally slid back along the plurality of rods 1504, the cup 1514 or pin optionally pushes the device 1502 (not shown). Fig.15D ) detach from a distal end of the plurality of rods 1504.

[0577] Reference now Fig.16A and 16B , Fig.16A and 16B According to an exemplary embodiment of the present invention, a device for delaying production is prepared. Fig.15A and 15B A simplified illustration of the insertion tool and a clamping tool for clamping a cervix.

[0578] Fig.16A is a cross-sectional side view, and Fig. 16B This is an isometric view.

[0579] Additional References Fig. 16C , Fig. 16C According to an exemplary embodiment of the present invention, a device for inserting a device for delaying production is provided. Fig.15A and 15B The insertion tool and the clamping device for clamping the cervix Fig.16A A simplified illustration of the clamping tool.

[0580] Figures 16A to 16CAn insertion tool 1604 is shown, a device for delaying production 1602 is connected to the insertion tool 1604, and a clamping tool 1606, such as, by way of non-limiting example, Fig.14A and 14B The clamping tool 1400 or Fig. 14C and 14D The clamping tool 1420 passes through the insertion tool 1604.

[0581] Fig.16A and 16B The insertion tool 1604, the device 1602, and the clamping tool 1606 are shown assembled as they would be assembled, by way of a non-limiting example, prior to insertion into a vagina.

[0582] In some embodiments, the assembly of the insertion tool 1604, the device 1602, and the clamping tool 1606 is optionally inserted into a vagina as is.

[0583] In some embodiments, the assembly of the insertion tool 1604, the device 1602, and the jaw tool 1606 is optionally inserted via a spreader.

[0584] In some embodiments, a control rod 1608 of the insertion tool 1604 is optionally squeezed, optionally squeezed by operating a control rod 1608, and a cross-sectional area of ​​the insertion tool is optionally reduced before the assembly of the insertion tool 1604, the device 1602 and the clamping tool 1606 is inserted into a vagina.

[0585] Fig. 16C The insertion tool 1604, the device 1602, and the clamping tool 1606 are shown as they would be in a vagina, with the insertion tool 1604 in an uncompressed state and the clamping tool clamping a cervix 1610.

[0586] Reference now Fig.16D , Fig.16D According to an exemplary embodiment of the present invention, a clamping tool pulls a cervix into a device for delaying childbirth, Figures 16A to 16C A simplified illustration of the insertion device.

[0587] Fig.16D The clamping tool 1606 is shown clamping the cervix 1610 , and optionally pulling the cervix 1610 , and optionally positioning the device 1602 for delaying production high above the cervix 1610 . Fig.16D The clamping tool 1606 is shown being pulled back relative to the insertion tool 1604 .

[0588] After positioning the device 1602 for delaying labor on the cervix 1610 , a mechanism for detaching the device 1602 for delaying labor from the insertion tool 1604 is optionally operated to detach the device 1602 .

[0589] In some embodiments, operating the mechanism for detaching the device 1602 optionally includes pressing one or more of the button(s) 1612 .

[0590] In some embodiments, operating the mechanism for detaching the device 1602 optionally includes operating a handle 1614 .

[0591] In some embodiments, there are six rods 1504 in the insertion tool 1500. In some embodiments, the rods at 12 o'clock and 6 o'clock are optionally attached to the optional grip 1507 and are not designed to be pushed forward. The other 4 rods can be pushed forward. Such a configuration potentially allows for positioning the device 1502 accurately and high around the cervix in a manner that potentially positions an upper ring of the device 1502 in the fornix, potentially contacting tissue surrounding the fornix.

[0592] Reference now Fig.16E , Fig.16E According to an exemplary embodiment of the present invention, a device for delaying production is separated from Figures 16A to 16C A simplified illustration of the insertion tool.

[0593] Fig.16E The distal ends 1616 of the insertion tool 1604 are shown detached from the device 1602 .

[0594] Fig.16E The cervical clamping tool 1606 is not shown. In some embodiments, the cervical clamping tool 1606 is optionally withdrawn from the insertion tool 1604 before the device 1602 is separated from the insertion tool 1604. In some embodiments, the cervical clamping tool 1606 is optionally withdrawn from the insertion tool 1604 after the device 1602 is separated from the insertion tool 1604.

[0595] In some embodiments, the cervical clamping tool 1606 is withdrawn from the vagina before the insertion tool 1604 is separated from the device 1602.

[0596] In some embodiments, the cervical clamping tool 1606 is withdrawn from the vagina before the insertion tool 1604 is withdrawn from the vagina and after the insertion tool 1604 is separated from the device 1602 .

[0597] In some embodiments, the cervical clamping tool 1606 and the insertion tool 1604 are withdrawn from the vagina together.

[0598] Reference now Fig.16F , Fig.16F is a simplified flow chart of a method for placing a device for delaying labor on a cervix according to an exemplary embodiment of the present invention.

[0599] The cervix may be at times in an anterior, a posterior, a left-handed, or a right-handed angle.

[0600] In some embodiments, a clamping tool is optionally used to clamp and center the cervix to allow for good placement of the device.

[0601] In some embodiments, an insertion tool may optionally include a scope that allows the insertion process to be visualized on a screen, on a proximal end of the insertion tool and / or an external screen. The use of a screen potentially allows for good visualization of the cervix and the insertion process.

[0602] In some embodiments, a method for placing a device for delaying labor on a cervix optionally includes:

[0603] Connecting a device for delaying production to an insertion tool (1632);

[0604] Clamping the cervix using a cervical clamping tool (1634);

[0605] An insertion tool encircling the cervical clamping tool is inserted into the vagina (1636).

[0606] positioning the device on the cervix (1638);

[0607] Releasing the insertion tool (1640) from the device;

[0608] withdrawing the clamping tool (1642) from the vagina; and

[0609] The insertion tool (1644) is withdrawn from the vagina.

[0610] In some embodiments, prior to connecting the device to the insertion tool, the cervical clamping tool is optionally inserted into the vagina, and a diameter of the cervix is ​​optionally measured.

[0611] In some embodiments, optionally based on the measurements, a correct size of a device for delaying production is optionally selected.

[0612] In some embodiments, the device is optionally connected to the insertion tool with optional markings at 12 o'clock and at 6 o'clock.

[0613] In some embodiments, clamping of the cervix by the cervical clamping tool is performed on both sides of the cervix, optionally at 3 o'clock and 9 o'clock.

[0614] In some embodiments, clamping of the cervix is ​​optionally performed after inserting the insertion tool around the cervical clamping tool into the vagina.

[0615] In some embodiments, the placement of the insertion tool and / or the clamping tool is accomplished via an opener.

[0616] In some embodiments, after positioning the device on the cervix, the position of the device is optionally adjusted by pressing the ends of the plurality of rods. The device is optionally positioned at the fornix.

[0617] In some embodiments, said withdrawing the clamping tool from the vagina is performed together with said withdrawing the insertion tool from the vagina.

[0618] In some embodiments, said withdrawing the clamping tool from the vagina is performed before said withdrawing the insertion tool from the vagina.

[0619] In some embodiments, said withdrawing said insertion tool from said vagina is performed before said withdrawing said clamping tool from said vagina.

[0620] In some embodiments, such as shown in Figures 16A to 16E In the example in FIG. 1 , there are six rods 1504 in the insertion tool 1500. In some embodiments, the rods at 12 o'clock and 6 o'clock are optionally connected to the optional handle 1507 and are not designed to be pushed forward. The other four rods can be pushed forward. Such a configuration potentially allows for accurately and high positioning of the device 1502 around the cervix in a manner that potentially positions an upper ring of the device 1502 in the fornix, potentially contacting tissue around the fornix.

[0621] Reference now Figures 17A to 17C , Figures 17A to 17C is a simplified illustration of a device for delaying labor placed about a cervix according to an exemplary embodiment of the present invention.

[0622] Figures 17A to 17C A device for delaying labor is shown placed around a cervix 1710, and vaginal wall 1712 is also shown. The cervix 1710 is optionally in a state corresponding to pregnancy, and not yet labor or delivery.

[0623] Fig.17A This is a side cross-sectional view. Fig. 17B is an isometric bottom view and Fig. 17C It is an upward view.

[0624] Figures 17A to 17C A device for delaying childbirth is shown, comprising an upper ring 1702 placed around the cervix 1710, legs 1704 and feet 1706 surrounded by a band 1708. The band 1708 presses on the legs 1704, pressing the feet 1706 against the cervix 1710.

[0625] The device for delaying labor presses against the cervix 1710 and potentially helps maintain the cervix supporting a fetus and potentially delays funneling and / or dilation of the cervix and / or premature labor and / or early delivery.

[0626] However, labor or delivery may begin, and in some embodiments, the device for delaying delivery is optionally configured to support the cervix to a specific point in time, then yield, releasing the cervix and allowing the delivery to occur. In some embodiments, the "yielding" is by the device flipping over, the upper ring releasing the cervix and / or the plurality of anchors releasing the cervix.

[0627] Reference now Figures 18A to 18C , Figures 18A to 18C are several simplified illustrations of a device for delaying labor placed around a cervix while the cervix is ​​under pressure according to an exemplary embodiment of the present invention.

[0628] Figures 18A to 18C A device for delaying labor is shown placed around a cervix 1810 while the cervix 1810 is under pressure, and the vaginal wall 1812 is also shown. The cervix 1810 is optionally in a state under pressure from above, and the device has not yet been released from the cervix 1810.

[0629] Fig.18A is a cross-sectional side view, Fig.18B is an isometric bottom view and Fig.18C It is an upward view.

[0630] Figures 18A to 18CA device for delaying childbirth is shown, comprising an upper ring 1802 placed around the cervix 1810, legs 1804 and feet 1806 surrounded by a band 1808. The band 1808 presses on the legs 1804, pressing the feet 1806 against the cervix 1810.

[0631] However, the cervix 1810 is in a position greater than that shown in Figures 17A to 17C A state in which the cervix 1710 is more dilated. The upper ring 1802 is more dilated, a top of the legs 1804 is extended laterally, and the legs are more inward, toward a center of a lumen defined by the shape of the device.

[0632] In some embodiments, under additional pressure from the cervix 1810 , the device flips and the upper ring 1802 optionally flips the strap 1808 and the feet of the legs 1806 in a direction indicated by arrow 1814 .

[0633] It should be noted that pressure may come from the uterus. This pressure may cause dilation of the internal os of the cervix and such pressure may potentially affect the upper ring of the device.

[0634] Reference now Fig.18D and 18E , Fig.18D and 18E is a simplified illustration of a device for delaying labor after inversion on a cervix according to an exemplary embodiment of the present invention.

[0635] Fig.18D is a cross-sectional side view and Fig.18E It is an upward view.

[0636] Fig.18D and 18E A device for delaying labor is shown, comprising an upper ring 1802 placed around the cervix 1810, several legs 1804 and several feet 1806 and a belt 1808.

[0637] The device has been turned over and, for example, Fig.18A , the feet 1806 are pressed against one side of the cervix 1810 and are now pointing outwards, not against the cervix.

[0638] In some embodiments, the plurality of feet 1806 no longer anchor the device to the cervix.

[0639] In some embodiments, the pressure exerted by the cervix on the device, sufficient to invert the device, is sufficient to slide the device off the cervix.

[0640] Reference now Fig.19 , Fig.19 is a simplified method for delaying production according to an exemplary embodiment of the present invention.

[0641] Fig.19 The method comprises the steps of:

[0642] A device for delaying childbirth is provided, wherein the device forms a lumen (1902) for surrounding the cervix; the device is placed into a vagina so that the lumen surrounds the cervix (1904);

[0643] Positioning the device so that the upper ring surrounds the cervix in a vault at a level of the internal cervical os (1906); and

[0644] The device is positioned so that it clamps the cervix (1908).

[0645] Reference now Fig. 20 , Fig. 20 is a simplified method for delaying production according to an exemplary embodiment of the present invention.

[0646] Fig. 20 The method comprises the steps of:

[0647] Providing an insertion tool and a device (2002) for delaying production connected to a distal end of the insertion tool;

[0648] Insert the distal end of the insertion tool into the vagina (2004);

[0649] Manipulating the insertion tool so that the device surrounds the cervix (2006);

[0650] detaching the device from the insertion tool, leaving the device to clamp the cervix (2008); and

[0651] Withdrawal of the insertion tool from the vagina (2010).

[0652] In some embodiments, positioning the device so that the upper ring surrounds the cervix in a vault located at a level of the internal cervical os means positioning the device so that the upper ring surrounds the cervix in a vault within about 0 to 10, 15, 20, 25, 30, 40 and 50 mm, for example within 5 mm, from the level of the internal cervical os.

[0653] As used herein, the term "about" means ± 10%.

[0654] The words "comprising", "including", "having" and their variations mean "including but not limited to".

[0655] "Consisting of" is intended to mean "including and limited to."

[0656] "Consisting essentially of" means that the composition, method or structure may include additional ingredients, steps and / or parts only when the additional ingredients, steps and / or parts do not materially change the basic and novel characteristics of the claimed composition, method or structure.

[0657] As used herein, the singular forms "a", "an", and "the" include plural referents unless the context clearly indicates otherwise. For example, "a component" or "at least one component" may include a plurality of components, including combinations thereof.

[0658] The words "example" and "exemplary" are used herein to mean "serving as an example, instance, or illustration." Any embodiment described as an "example" or "exemplary" is not necessarily to be construed as preferred or advantageous over other embodiments and / or to exclude the incorporation of features from other embodiments.

[0659] The word “optional” is used herein to mean “provided in some embodiments and not provided in other embodiments.” Any particular embodiment of the present invention may include several “optional” features, unless such features are in conflict.

[0660] Throughout this application, various embodiments of the present invention may be presented in a range format. It should be understood that the description in range format is only for convenience and brevity, and should not be regarded as an inelastic limitation of the scope of the present invention. Therefore, the description of a range should be regarded as having specifically disclosed all possible sub-ranges and individual numerical values ​​in the range. For example, a range, such as from 1 to 6, should be regarded as having specifically disclosed several sub-ranges, such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6, etc., and individual numbers in the range, for example 1, 2, 3, 4, 5 and 6. This applies regardless of the width of the range.

[0661] Whenever a numerical range is indicated herein, the numerical range is intended to include any cited numeral (fractional or integer) within the indicated range. "Between" a first indicated numeral and a second indicated numeral and "from" a first indicated numeral "to" a second indicated numeral are used interchangeably herein and are intended to include the first and second indicated numerals and all fractions and integers therebetween.

[0662] As used herein, the term "method" means methods, means, techniques and procedures for accomplishing a given task, including but not limited to methods, means, techniques and procedures known to practitioners of engineering, chemistry, pharmacy, biology, biochemistry and medical arts and methods, means, techniques and procedures that are readily developed therefrom.

[0663] As used herein, the term "treating" includes eliminating, substantially inhibiting, slowing or reversing the progression of a disorder, substantially ameliorating the clinical or sensory symptoms of a disorder or substantially preventing the onset of clinical or sensory symptoms of a disorder.

[0664] It should be understood that certain features of the invention that are described in the context of separate embodiments for the sake of clarity may also be provided in a single embodiment. Conversely, various features of the invention that are described in the context of a single embodiment for the sake of brevity may also be provided in any other described embodiment of the invention, separated or in any suitable subcombination. Certain embodiments described in the context of various embodiments are not to be considered essential features of those embodiments unless the embodiments are inoperative without those features.

[0665] Although the present invention has been described in conjunction with its specific embodiments, it is obvious that many alternatives, modifications and variations will be apparent to those skilled in the art. Therefore, the present invention is intended to embrace all such alternatives, modifications and variations that fall within the spirit and scope of the appended claims.

[0666] All publications, patents and patent applications mentioned in this specification are incorporated by reference in their entirety into this specification to the same extent as if each individual publication, patent and patent application was specifically and individually indicated to be incorporated by reference herein. In addition, the citation or identification of any reference in this application should not be construed as an admission that such reference may serve as prior art to the present invention. Where section headings are used, they should not be construed as necessarily limiting.

[0667] Furthermore, any priority document(s) to this application are incorporated herein by reference in their entirety.

Claims

1. A device for delaying production, characterized in that: A lumen is formed to surround a cervix, the device comprising: an upper ring for surrounding the cervix; and an anchor for anchoring the device to the cervix, in The anchor comprises a plurality of anchoring elements, each of the plurality of anchoring elements comprising a leg connected at one end to the upper ring and extending downwardly along the cervix, the leg comprising another lower end configured to anchor to the cervix.

2. The device according to claim 1, characterized in that: The upper ring has an inner diameter that is greater than an inner diameter of the anchor and includes a hinge location such that when an axial force is applied to the upper ring toward the anchor, the force pushes the anchor toward the cervix.

3. The device according to claim 1, characterized in that: Further included is a strap surrounding the anchor.

4. The device according to claim 3, characterized in that: The strap comprises an elastic strap to generate radial pressure of the anchor on the cervix.

5. The device according to claim 1, characterized in that: At least one anchoring element comprises a foot having a protrusion toward a cervical side, the protrusion having a shape selected from the group consisting of: A single rectangular protrusion toward one side of the cervix; A spherical protrusion facing the cervix; Two rectangular protrusions facing the cervix; and A hemispherical protrusion, wherein the rounded side of the hemispherical protrusion faces the cervix.

6. The device according to claim 1, characterized in that: The upper ring includes a plurality of gaps on the inner side of the upper ring so that the plurality of gaps do not compress the cervix.

7. The device according to claim 1, characterized in that: At least one leg is more rigid than the upper ring.

8. The device according to claim 1, characterized in that: At least one of the legs is elastic.

9. The device according to claim 1, characterized in that: The anchor is configured to non-invasively anchor the device to the cervix.

10. The device according to claim 1, characterized in that: The anchor comprises a needle.

11. The device according to claim 1, characterized in that: The upper ring is elastic.

12. The device according to claim 1, characterized in that: The upper ring contains a spring.

13. The device according to claim 3, characterized in that: The strip includes a spring.

14. The device according to claim 1, characterized in that: The upper ring includes a vibrating mechanism.

15. The device according to claim 1, characterized in that: The upper ring comprises a metal ring.

16. The device according to claim 1, characterized in that: The plurality of anchoring elements are equidistantly distributed around the lumen.

17. The device according to claim 1, characterized in that: The plurality of anchoring elements are distributed non-equidistantly around the lumen.

18. The device according to claim 1, characterized in that: An adhesive material is further included on an inner side of at least one anchoring element.

19. The device according to claim 1, characterized in that: Further comprising a sensor for measuring data regarding a patient condition, the patient condition selected from the group consisting of: shrink; - dilation of the cervix; the progress of labor; Premature birth Full-term pregnancy; and A condition of a fetus.

20. The device according to claim 19, characterized in that: Further included is a transmitter for transmitting the data.

21. The device according to claim 1, characterized in that: Further included is an element for fluidizing a drug.

22. The device according to claim 1, characterized in that: The device is marked with contrast material to allow detection of a position of the device on the cervix using a medical imaging method.

23. A device for delaying production, characterized in that: A lumen is formed to surround a cervix, the device comprising: an upper ring for encircling the cervix; an anchoring mechanism for anchoring the device to the cervix; and a pivot mechanism configured so that when an axial force is applied to the upper ring toward the anchoring mechanism, the force pushes the anchoring mechanism toward the cervix; The diameter of the device ranges from 10 mm to 60 mm.

24. The device according to claim 23, characterized in that: The pivot mechanism includes a strap encircling the anchoring mechanism.

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