Insertion tool, clamping tool and device for detecting production

Abstract

The invention relates to an insertion tool, a jaw tool and a device for delaying production. The insertion tool is used for inserting a device for delaying production. The device includes a device lumen for encircling a cervix. The invention relates to an insertion tool for a device for slowing production, said insertion tool comprising: a plurality of rods linked to at least two rings forming a longitudinal tool lumen, each rod comprising: a connector at a distal end of said rod for linking to said device for slowing production; and a mechanism at a proximal end of the rod for separating the device for delaying production at the distal end of the rod.

Description

[0001] This application is a divisional application of application No. 201980052404.6 (PCT application No. PCT / IL2019 / 050696), with a filing date of June 20, 2019 and an invention title of "Delaying Preterm Birth".

[0002] Cross - reference to related applications

[0003] 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 content of the above - mentioned applications is incorporated herein by reference as if fully set forth herein. Technical field

[0004] The present invention relates to devices and methods for delaying preterm birth or inducing early labor, and more particularly, but not exclusively, to devices inserted into the vagina and around the cervix and associated methods. Background art

[0005] Preterm birth (delivery between 24 and 37 weeks of gestation) is the leading cause of neonatal death and disease. Worldwide, 15 million babies are born preterm each year. One million will die and one million will suffer from major lifelong complications: respiratory disorders, feeding disorders or neurological disabilities: blindness, hearing loss, neurodevelopmental delay or cerebral palsy. Preterm infants impose a huge financial burden on society. In the United States, the costs associated with preterm birth exceed $26 billion per year.

[0006] The main risks for spontaneous preterm birth, which accounts for approximately 50% of preterm births, are previous preterm birth, twin or multiple pregnancies, cervical shortening, cervical insufficiency, uterine premature contractions (PMC), or a combination of the above.

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

[0008] The disclosure of all references throughout this specification, and the disclosure of all references mentioned in those references, are incorporated herein by reference. Summary of the invention

[0009] One aspect of some embodiments of the present invention relates to placing a device into a vagina for safely supporting the cervix, preventing the progression of cervical dilatation, effacement, or funneling, and preventing or delaying preterm delivery.

[0010] According to one aspect of some embodiments of the present invention, there is provided a device for delaying childbirth, 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 to the cervix.

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

[0012] According to some embodiments of the present invention, the anchoring mechanism includes a plurality of anchoring elements.

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

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

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

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

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

[0018] According to some embodiments of the present invention, the plurality of anchoring elements includes a protrusion towards the inside of the lumen, the protrusion being designed to resist the movement of the anchoring element along the tissue.

[0019] According to some embodiments of the present invention, the plurality of anchoring elements includes an adhesive material directed towards the inside of the lumen, designed to resist the movement of the anchoring element along the tissue.

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

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

[0022] According to some embodiments of the present invention, the strip includes an elastic ring around the anchoring mechanism.

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

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

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

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

[0027] According to some embodiments of the present invention, at least some of the plurality of anchoring elements include 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 present invention, the number of the plurality of anchoring elements is an even number in a range inclusively from two to twenty.

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

[0032] According to some embodiments of the present invention, it further includes an element for measuring data from a group consisting of: contractions, dilation of a cervix, and progress of childbirth.

[0033] According to some embodiments of the present invention, it further includes an element for collecting data from a group consisting of: contractions, dilation of a cervix, and progress of childbirth.

[0034] According to some embodiments of the present invention, it further includes an element for dialysis of a drug.

[0035] According to some embodiments of the present invention, it further includes an element for collecting data related to preterm birth.

[0036] According to some embodiments of the present invention, it further includes an element for collecting data related to full-term pregnancy.

[0037] According to some embodiments of the present invention, it further includes an element for collecting data related to the condition of a fetus.

[0038] According to some embodiments of the present invention, it further includes a vibration mechanism for soothing and relaxation.

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

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

[0041] According to some embodiments of the present invention, the insertion includes compressing the device to pass through a vaginal entrance. According to some embodiments of the present invention, the insertion includes compressing the device to pass through a vaginal entrance.

[0042] According to some embodiments of the present invention, the insertion includes twisting the device to pass through a vaginal entrance.

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

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

[0045] According to some embodiments of the present invention, positioning the device such 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 to push the upper ring up along the cervix.

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

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

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

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

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

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

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

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

[0054] According to some embodiments of the present invention, further includes connecting the device to a cervix using a biological adhesive.

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

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

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

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

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

[0061] In some embodiments, the placement tool is optionally widened after passing through the narrow lumen, optionally expanding and laterally pushing against the sides of the lumen after passing through as a tool with a narrower profile.

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

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

[0064] In some embodiments, the several jaws can optionally open to a width of 5 centimeters, and the clamping tool does not increase in width for most of its length, for example, more than 80% or 90% of its width.

[0065] In some embodiments, the several jaws are configured to expand to a width greater than 4 times the width of the extension tool.

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

[0067] In some embodiments, the clamping tool controls the expansion of the several jaws via a linear movement of several controllers along the extension clamping tool, unlike, for example, scissors where the handles move laterally to control the opening of the scissors. Such several exemplary embodiments are described with reference to Figures 14A to 14E and are described.

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

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

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

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

[0072] According to some embodiments of the present invention, the anchor includes a plurality of anchoring elements.

[0073] According to some embodiments of the present invention, the upper ring is configured to leave a plurality of free spaces or gaps on the inner side of the upper ring, such that the plurality of free 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 free spaces or gaps around the lumen of the cervix.

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

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

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

[0078] According to some embodiments of the present invention, the leg is more rigid than the upper ring.

[0079] According to some embodiments of the present invention, the leg is elastic.

[0080] According to some embodiments of the present invention, it further includes a band surrounding the anchoring mechanism.

[0081] According to some embodiments of the present invention, the band includes an elastic band to generate a radial pressure of the plurality of anchors applied to the cervix.

[0082] According to some embodiments of the present invention, the band includes a metal ring.

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

[0084] According to some embodiments of the present invention, the upper ring includes a spring. According to some embodiments of the present invention, the upper ring includes 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 an electric current passes through. In some embodiments, the vibration mechanism includes a motor and an off-center weight that creates vibration when the motor rotates. In some embodiments, the device includes a battery for driving the vibration mechanism.

[0086] In some embodiments, the vibration mechanism includes an eccentric rotating mass, such as an unbalanced mass on an (optionally DC) motor or a linear resonant actuator that includes a small internal mass connected 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 non-harmonic.

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

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

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

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

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

[0092] According to some embodiments of the present invention, it further includes a sensor for measuring data from the group consisting of: contractions, dilation of the cervix, and the progress of childbirth.

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

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

[0095] According to some embodiments of the present invention, placing the device such that the device clamps the cervix includes: placing the device to press against the cervix and assist in preventing the cervix from opening, dilating, and causing the cervix to become funnel-shaped.

[0096] According to some embodiments of the present invention, positioning the device such that the upper ring surrounds the cervix in a fornix at a level located at the internal os of the cervix includes positioning the device such that the upper ring surrounds the cervix in a fornix within 5 to 30 millimeters of a level from the internal os of the cervix.

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

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

[0099] According to some embodiments of the present invention, the inserting includes: changing a shape of the device to pass through a speculum.

[0100] According to some embodiments of the present invention, the inserting includes twisting the device to pass through a vaginal orifice.

[0101] According to some embodiments of the present invention, the inserting includes twisting the device to pass through a speculum.

[0102] According to some embodiments of the present invention, positioning the device such 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 present invention, positioning the device such 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 includes a strip surrounding the device, and further comprises: removing the strip from around the device.

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

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

[0107] According to one aspect of some embodiments of the present invention, there is provided a device for delaying childbirth, forming a lumen for surrounding a cervix, the device comprising: an upper ring for surrounding the cervix, an anchoring mechanism for anchoring the device to the cervix, and a pivot location configured such that when the upper ring is pushed outwards from an axis of the lumen, the upper ring rotates about the pivot and releases the anchoring of the device on the cervix.

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

[0109] According to some embodiments of the present invention, the pivot mechanism includes a strip 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 including 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 including: a connector at a distal end of the rod for connecting to the device for delaying childbirth, and an arrangement 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 rings are 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, and further comprising 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 present invention, moving the plurality of rods causes the plurality of rings to change an angle at which the plurality of rods are connected to the plurality of rings.

[0115] According to some embodiments of the present invention, the control lever 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 longitudinally moves one or more of the rods 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 includes a grip connected to at least one of the plurality of rods.

[0117] According to some embodiments of the present invention, the control lever is connected to a pivot included in the grip.

[0118] According to some embodiments of the present invention, in the implantation tool, there are a plurality of channels along the plurality of rods, and the plurality of channels allow a biological adhesive or an adhesive material or a polysiloxane to be distributed to the plurality of legs of the device before the release of the device for delaying production, so as 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, including: two jaws for clamping a cervix, a pivot connecting the two jaws to enable the plurality of jaws to separate and close from each other, an extension tool connected to the two jaws, and a plurality of controllers for opening and closing the two jaws, wherein the plurality of jaws are configured to expand to a width greater than 4 times the width of the extension tool.

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

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

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

[0123] According to one aspect of some embodiments of the present invention, there is provided a method for delaying childbirth, including the steps of: providing an implantation tool and a device for delaying childbirth connected to a distal end of the implantation tool, inserting the distal end of the implantation device into a vagina, manipulating the implantation tool to cause the device to surround a cervix, separating the device from the implantation tool, leaving the device to clamp the cervix, and withdrawing the implantation tool from the vagina.

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

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

[0126] According to some embodiments of the present invention, it further includes reducing a cross-section of the 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 insertion includes reducing a cross-section of the lumen of the insertion tool to pass through a speculum.

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

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

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

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

[0132] According to some embodiments of the present invention, it further includes: 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 includes: pulling the cervix with the clamping tool before the device separates from the insertion tool.

[0134] According to some embodiments of the present invention, it further includes: pushing the insertion tool before the device separates from 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 childbirth, forming a lumen for surrounding a cervix, the device including: an upper ring for surrounding the cervix, and an anchor for anchoring the device on the cervix.

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

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

[0138] According to some embodiments of the present invention, the anchor includes a needle tip.

[0139] According to some embodiments of the present invention, the anchor includes a plurality of anchoring elements.

[0140] According to some embodiments of the present invention, the upper ring includes a plurality of gaps around the 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 present invention, the upper ring is elastic.

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

[0144] According to some embodiments of the present invention, each of the plurality of anchoring elements includes a leg, and wherein the leg is configured to be anchored to the cervix.

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

[0146] According to some embodiments of the present invention, the leg is more rigid than the upper ring.

[0147] According to some embodiments of the present invention, the leg is elastic.

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

[0149] According to some embodiments of the present invention, the band includes an elastic band to generate a radial pressure of the plurality of anchors applied to the cervix.

[0150] According to some embodiments of the present invention, the band includes a spring.

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

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

[0153] According to some embodiments of the present invention, the upper ring includes a vibration mechanism.

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

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

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

[0157] According to some embodiments of the present 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, a sensor is further included for measuring data from a group consisting of: contractions, dilation of a cervix, and progress of childbirth.

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

[0163] According to some embodiments of the present invention, an element for dialysis of a drug is further included.

[0164] According to one aspect of some embodiments of the present invention, a method for delaying childbirth is provided, the method including the steps of: providing a device for delaying childbirth, the device forming a lumen for surrounding a cervix, placing the device into a vagina such that the lumen surrounds the cervix, positioning the device such that the upper ring surrounds the cervix in a fornix at a level at the internal os of the cervix, and placing the device such that the device clamps the cervix.

[0165] According to some embodiments of the present invention, placing the device such that the device clamps the cervix includes: placing the device to press against the cervix and assist in preventing the cervix from opening, dilating, and becoming funnel-shaped.

[0166] According to some embodiments of the present invention, positioning the device such that the upper ring surrounds the cervix in a fornix at a level located at the internal os of the cervix includes: positioning the device such that the upper ring surrounds the cervix in a fornix within 5 millimeters of a level of the internal os of the cervix.

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

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

[0169] According to some embodiments of the present invention, the insertion includes: changing the shape of the device to pass through a speculum.

[0170] According to some embodiments of the present invention, the insertion includes twisting the device to pass through a vaginal opening.

[0171] According to some embodiments of the present invention, the insertion includes twisting the device to pass through a speculum.

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

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

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

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

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

[0177] According to some embodiments of the present invention, the insertion includes: changing the shape of the device to pass through a speculum.

[0178] According to some embodiments of the present invention, the insertion includes twisting the device to pass through a vaginal opening.

[0179] According to some embodiments of the present invention, the insertion includes rotating the device to pass through a vaginal opening.

[0180] According to some embodiments of the present invention, the insertion includes twisting the device to pass through a speculum.

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

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

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

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

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

[0186] According to one aspect of some embodiments of the present invention, there is provided a device for delaying childbirth, forming a lumen for surrounding a cervix, the device including: an upper ring for surrounding the cervix, an anchoring mechanism for anchoring the device to the cervix, and a pivot location configured such that when the upper ring is pushed outward from an axis of the lumen, 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 includes a plurality of anchoring elements, each of the plurality of anchoring elements including a leg, and the leg being configured to be anchored to the cervix.

[0188] According to some embodiments of the present invention, the pivot mechanism includes a strip surrounding the anchoring mechanism.

[0189] In accordance with one aspect of some embodiments of the present invention, there is provided an insertion tool for inserting a device for delaying childbirth, the device including a device lumen for surrounding a cervix, the tool including: a plurality of rods connected to at least two rings to form a longitudinal tool lumen, each rod including: 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.

[0190] In accordance with some embodiments of the present invention, the plurality of rods are elastically connected to the plurality of rings, allowing a cross-section of the longitudinal tool lumen to expand and contract.

[0191] In accordance with 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] In accordance with some embodiments of the present invention, based on the ability of the longitudinal tool lumen to expand and contract in cross-section, it is configured to connect devices for delaying childbirth of different sizes.

[0193] In accordance with some embodiments of the present invention, it further includes a control rod for moving the plurality of rods closer to each other, thereby reducing a cross-section of the tool lumen.

[0194] In accordance with some embodiments of the present invention, moving the plurality of rods causes the plurality of rings to change an angle at which the plurality of rods are connected to the plurality of rings.

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

[0196] In accordance with some embodiments of the present invention, the plurality of rods are configured to move apart from each other, thereby expanding a cross-section of the tool lumen and expanding a connected device for delaying childbirth.

[0197] In accordance with some embodiments of the present invention, the plurality of rods include a plurality of channels along the plurality of rods for applying an adhesive material to a device for delaying childbirth.

[0198] In accordance with some embodiments of the present invention, it further includes a grip connected to at least one of the plurality of rods.

[0199] In accordance with some embodiments of the present invention, the control rod is connected to a pivot included in the grip.

[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 pivot connecting the two jaws to enable the jaws to separate and close from each other, an extension tool connected to the two jaws, and a plurality of controllers for opening and closing the two jaws, wherein the jaws are configured to expand to a width greater than four times the width of the extension tool.

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

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

[0203] According to some embodiments of the present invention, it further includes a scale for indicating a distance between the two jaws.

[0204] According to some embodiments of the present invention, it further includes a scale for indicating an angle between the two jaws.

[0205] According to one aspect of some embodiments of the present invention, there is provided a method for delaying childbirth, comprising the steps of: providing an insertion tool and a device for delaying childbirth connected to a distal end of the insertion tool, inserting the distal end of the insertion device into a vagina, manipulating the insertion tool to cause the device to surround a cervix, separating the device from the insertion tool, leaving the device to clamp 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 childbirth is a device for delaying childbirth as described herein.

[0208] According to some embodiments of the present invention, it further includes: 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 insertion includes contracting a cross-section of the lumen of the insertion tool to pass through a speculum.

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

[0211] According to some embodiments of the present invention, it further includes: operating the device to clamp the cervix at the highest possible position on the cervix.

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

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

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

[0216] According to some embodiments of the present invention, it further includes: before separating the device from the insertion tool, pushing the insertion tool so as to push the device upward along the cervix.

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

[0218] Brief description of several views of the drawings

[0219] Some embodiments of the present invention are described herein only by way of example and with reference to the accompanying drawings. Now referring in detail to the drawings, 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 the several embodiments of the present invention can be implemented.

[0220] In the drawings:

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

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

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

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

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

[0226] Figure 6A and 6B is a simplified diagram of a device for delaying childbirth according to an exemplary embodiment of the present invention;

[0227] Figure 7A and 7B are images of several exemplary embodiments of a device for delaying childbirth according to an exemplary embodiment of the present invention;

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

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

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

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

[0232] Figure 12 is a simplified flowchart illustration of a method for delaying childbirth according to another exemplary embodiment of the present invention;

[0233] Figure 13A and 13B is a simplified diagram of a device for delaying childbirth according to an exemplary embodiment of the present invention;

[0234] Figure 13C and 13D is a simplified view of an apparatus for delaying childbirth, according to an exemplary embodiment of the present invention;

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

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

[0237] Figure 14A and 14B is a simplified view of a cervix clamping tool, according to an exemplary embodiment of the present invention;

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

[0239] Figures 15A to 15D is a simplified view of an insertion tool for inserting an apparatus for delaying childbirth, according to an exemplary embodiment of the present invention;

[0240] Figure 16A and 16B is according to an exemplary embodiment of the present invention, preparing to insert an apparatus for delaying childbirth Figure 15A and 15B a simplified view of the insertion tool and a clamping tool for clamping a cervix;

[0241] Figure 16C is according to an exemplary embodiment of the present invention, inserting an apparatus for delaying childbirth Figure 15A and 15B the insertion tool and clamping Figure 16A a simplified view of the clamping tool of a cervix;

[0242] Figure 16D is according to an exemplary embodiment of the present invention, with a clamping tool pulling a cervix into an apparatus for delaying childbirth Figure 16A and 16B a simplified view of the insertion tool;

[0243] Figure 16E is according to an exemplary embodiment of the present invention, separated from an apparatus for delaying childbirth Figure 16A and 16B a simplified view of the insertion tool;

[0244] Figure 16Fis a simplified flowchart of a method for placing a device for delaying childbirth on a cervix according to an exemplary embodiment of the present invention;

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

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

[0247] Figure 18D and 18E is a simplified view of a device for delaying childbirth after being inverted on a cervix according to an exemplary embodiment of the present invention;

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

[0249] Figure 20 is a simplified method for delaying childbirth according to an exemplary embodiment of the present invention. Detailed Description

[0250] The present invention, in some of its embodiments, relates to devices and methods for delaying preterm or early childbirth, and more particularly, but not exclusively, to devices inserted 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 surrounding a cervix, the device having an anchoring mechanism that increases the pressure on the cervix in response to a force applied to an upper ring surrounding the cervix.

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

[0255] In some embodiments, during contractions, the upper ring of the device is pushed. This generates a force on the plurality of 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 creates a force that is 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 (several) anchoring elements, and the tip presses against the external tissue of the cervix. As the pressure of the (several) anchoring elements increases, the pressure between the (several) anchoring elements and the cervix tissue increases, and the reaction force that holds the upper ring in its position increases.

[0258] In some embodiments, the anchoring mechanism optionally pierces the cervix tissue with a needle and sutures the device to the cervix.

[0259] In some embodiments, the anchoring mechanism optionally pierces the cervix tissue with several pins.

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

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

[0262] In some embodiments, the adhesive assists in anchoring the device.

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

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

[0265] In some embodiments, the biological glue assists in anchoring the device.

[0266] In some embodiments, the pivot is around several legs that are designed to surround the cervix, and the feet of the several legs are designed to anchor to the cervix. Pressing outwardly and / or downwardly on the upper ring potentially causes the several legs to pivot inwardly and press against the cervix.

[0267] In some embodiments, the pivot is around a band that surrounds several legs that are designed to surround the cervix, and the feet of the several legs are designed to anchor to the cervix. Pressing outwardly and / or downwardly on the upper ring potentially causes the several legs to pivot inwardly and press against the cervix.

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

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

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

[0271] In some embodiments, there are a plurality of spacings between the plurality of legs such that some regions of a surface of the cervix are not pressed upon by the pressing elements, potentially relaxing the blood flow in the cervix, potentially relaxing the 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 segments of a circumference of the cervix, leaving other segments of the circumference of the cervix without pressing elements, potentially relaxing the blood flow in the cervix, potentially relaxing the venous blood flow that is close to a surface of the cervix.

[0273] In some embodiments, the device is marked to indicate one or more specific faces of the device, intended to indicate to a physician inserting the device the direction in which the device should be inserted and / or the direction in which 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 marked positions are described in terms of 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 an 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 devices may be provided, for example, by way of some non-limiting examples:

[0277] Having different radii of the upper ring, optionally a radius in the range from a sharp edge to 3 millimeters, 5 millimeters, 7 millimeters, 10 millimeters;

[0278] Having different upper ring thicknesses, optionally in the range from 3 to 15 millimeters;

[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 spaced evenly or unevenly around the upper ring;

[0280] Having different elasticity of the upper ring, optionally in the range of 20 to 90 Shore hardness (Shore A);

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

[0282] Having different radii of a lumen defined by the anchoring element;

[0283] Having different radii of a lumen defined between several anchoring legs;

[0284] Having different lengths of the anchoring legs, for example 5 to 40 millimeters below the upper ring;

[0285] Having different widths of the several anchoring legs;

[0286] Having different tolerances of the several legs, by way of non-limiting example, from 20 Shore hardness to fully rigid;

[0287] Having different elasticity of the several legs; and

[0288] Having different elasticity of an elastic strip for pressing the several legs against a cervix.

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

[0290] In some embodiments, the elastic strip has a Shore hardness in a range of 20 to 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 strip is connected to the several legs of the device.

[0293] In some embodiments, the elastic strip is included in a sleeve around the several 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 for clamping the cervix on a top and an anchoring element descending along the cervix.

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

[0296] In some embodiments, the device includes the upper element and several legs for anchoring to the cervix that descend along the cervix.

[0297] In some embodiments, the device includes the upper element, several legs for anchoring to the cervix that descend along the cervix, and a band for pressing the several legs onto the cervix.

[0298] In some embodiments, the upper element expands under lateral or downward pressure, the several legs are anchored to the cervix, and the upper ring flips, pivots, or rotates, flipping the device and the several legs over the cervix to weaken or release 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 the shape of a ring.

[0300] In some embodiments, the upper element includes an inner lumen for clamping and pressing against a specific section of the cervix and leaving other sections free from pressure, potentially at least relaxing the blood flow through the free sections.

[0301] In some embodiments, the upper element includes several protrusions for pressing on 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 present invention relates to a device for surrounding a cervix, having an upper ring designed to surround a cervix, several legs designed to point downward along the cervix, and a strap for pressing the several legs onto the cervix.

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

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

[0306] In some embodiments, the upper ring is used to press the cervix at or below a level of the internal os of the cervix and assist in preventing the cervix from opening, dilating, and funneling.

[0307] In some embodiments, the strap is used to press the several legs against the cervix and assist in preventing the cervix from opening.

[0308] In some embodiments, the upper ring is used to press the cervix and assist in preventing the cervix from opening, and the strap is used to press the several legs against the cervix and assist in preventing the cervix from opening.

[0309] In some embodiments, the strap is optionally elastic.

[0310] In some embodiments, the device is placed around the cervix, pressed onto the cervix, and closes the cervix. When the time comes to release the device, for example, when the physician deems it necessary to release the device at term or before term due to other medical indications, a physician may optionally cut the strap, releasing some or all of the pressure of the several legs on the cervix.

[0311] In some embodiments, when the time comes to release the device, for example, when the physician deems it necessary to release the device at term or before term due to other medical indications, a physician may optionally cut the ring, releasing some or all of the pressure of the several legs on the cervix and enabling removal.

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

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

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

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

[0316] In some embodiments, the scale provides data used in selecting a device for delaying preterm labor or inducing labor prematurely. The data can be provided as an angle at which the clamp tool is opened; as a distance by which the jaws of the clamp tool are opened; as a number representing a size of an upper ring of the device for delaying preterm 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 clamp tool optionally include a plurality of wheels that can be used to pull the cervix into the plurality of jaws.

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

[0320] In some embodiments, the device is connected to the insertion tool, and the insertion tool is for inserting the device onto a cervix via a vagina.

[0321] In some embodiments, the device is connected to the insertion tool, and the insertion tool is for inserting the device onto a cervix via a speculum in the vagina.

[0322] In some embodiments, the insertion tool compresses the device to present a smaller cross-section when inserted via the vagina.

[0323] In some embodiments, the placement tool is configured to stop compressing the device and allow the device to expand beside the cervix.

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

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

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

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

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

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

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

[0331] In some embodiments, the placement tool is configured to separate from the device when the device has been placed on the cervix.

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

[0333] In some embodiments, the placement tool is configured to separate from the device at more than one location, one location at a time or more than one location at a time.

[0334] In some embodiments, the placement tool is configured to separate from the device at all of the connection locations at once.

[0335] In some embodiments, the insertion tool compresses the device so as to present a smaller cross-section when inserted by a speculum in the vagina.

[0336] According to some embodiments of the present invention, the insertion tool includes a plurality of channels along the plurality of rods, the plurality of channels allowing a biological adhesive or an adhesive material or a silicone to be dispensed onto the plurality of legs of the device before release of the device for delaying childbirth to allow adhesion to the cervix.

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

[0338] In some embodiments, the clamping tool is for pulling the cervix towards an operator holding the clamping tool.

[0339] In some embodiments, the clamping tool is for pulling the cervix towards the device.

[0340] In some embodiments, the cervix is held in position and the insertion tool is for pushing the device onto the cervix.

[0341] In some embodiments, the cervix is pulled towards an operator and the insertion tool is for pushing the device onto the cervix. In some embodiments, the cervix is pulled towards the operator and the insertion tool is simultaneously used to push the device onto the cervix.

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

[0343] Words such as "up", "top", and "upper" in all their grammatical forms are used throughout the specification and claims to describe a direction towards the uterus.

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

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

[0346] In some embodiments, the device is placed in a vagina such that the upper ring surrounds the cervix, optionally at a level in the vaginal fornix, adjacent to the internal os of the cervix.

[0347] In some embodiments, the device is placed in a vagina such that the upper ring surrounds the cervix and is pushed up into the upper part of the fornix.

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

[0349] In some embodiments, by restricting cervical dilation, the biological cascade of a common pathway of childbirth 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, the amniotic sac in which the fetus is located is pushed in the direction of the cervix, causing funneling, and the ring redirects the generated force to apply a closing force to 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 of a common pathway of childbirth characterized by cervical remodeling, cervical ripening, uterine contractility, and fetal membrane activation is slowed or even prevented.

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

[0353] One 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 several protrusions for increasing the friction between the anchoring mechanism and a surface of a cervix where the device is placed.

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

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

[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 present invention relates to anchoring a device to a lower portion of a cervix, and a top portion of the device narrowing the cervical opening.

[0359] In some embodiments, the device includes 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, the length of the lumen of the device is less than the 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 exerts force, the force is dispersed and does not exert a concentrated force on any particular location on the cervix, potentially preventing tearing.

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

[0363] In some embodiments, sutures are not required, and the device is easily and simply deployed, potentially deployed without anesthesia, and potentially deployed in an outpatient or clinical procedure.

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

[0365] In some embodiments, automated suturing may optionally be used, potentially resulting in a simpler procedure, potentially eliminating the need for general anesthesia, potentially causing less damage to the organ being sutured, and potentially resulting in better device retention.

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

[0367] In some embodiments, the device is positioned by a physician in an outpatient 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 during a procedure that lasts several minutes.

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

[0371] In some embodiments, the device is removed before, during childbirth, or when a physician deems it necessary.

[0372] In some embodiments, the device is removed by a physician during a procedure that lasts several minutes.

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

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

[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) may 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 measurement values.

[0379] In some embodiments, the device optionally includes a contraction sensing element, e.g., by way of a 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 optionally drug eluting, optionally eluting a drug for delaying or progressing labor.

[0381] In some embodiments, the device optionally collects information related to preterm labor.

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

[0383] In some embodiments, one or more of the above-mentioned benefits can potentially be achieved.

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

[0385] Now refer to Figures 1A to 1B , Figures 1A to 1B which is a simplified illustration of a production process.

[0386] A main function of a cervix 102 is its role in childbirth. When a fetus 104 is ready to be born and descends, a presenting part is typically the head 106, which rests against and is supported by the cervix 102. The fetus 104 is surrounded by amniotic fluid 105 within an amniotic sac. This stage is depicted in Figure 1A .

[0387] When the cervix 102 begins to dilate, this support begins to give way. This stage is depicted by Figure 1B .

[0388] During childbirth, when the fetal head 106 or fetal buttocks are pushed from the uterus 103 into the vagina 101, the cervix 102 must dilate to a diameter greater than that of the fetal head 106 or fetal buttocks: the exact dimensions depend on the gestational age.

[0389] Near the time of childbirth, the cervix 102 also becomes shorter, a process known as effacement.

[0390] Now refer to Figure 2 ,Figure 2 is a simplified diagram of an apparatus for delaying childbirth according to an exemplary embodiment of the present invention.

[0391] Figure 2 An apparatus 200 is shown, which includes an apparatus 200 for surrounding a cervix and an anchoring mechanism 203 for anchoring the apparatus to the cervix.

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

[0393] Figure 2 A strip 202 surrounding the apparatus 200 is also shown. In some embodiments, the strip 202 is elastic. In some embodiments, the strip 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 into an inward rotational force on the anchoring mechanism 203, and an inner tip of the anchoring mechanism (the inner tip contacting an outer surface of a cervix) acts as a pivot at one or more points or along a line.

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

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

[0398] In some embodiments, the apparatus 200 is elastic and configured to be extended longitudinally, i.e., in a top-bottom direction.

[0399] In some embodiments, the apparatus 200 can be extended longitudinally, i.e., in a top-bottom direction.

[0400] In some embodiments, the apparatus 200 is elastic and configured to be compressed laterally, i.e., in a direction of decreasing diameter.

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

[0402] Now refer to Figure 3 ,Figure 3 is a simplified cross-sectional view of a pregnancy around a cervix with a device for delaying childbirth, 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 at an upper opening 306 of the cervix 304, called the internal os. A device 305 for delaying childbirth surrounds the cervix, optionally over a lower opening 307 (called the external os) of the cervix 304.

[0404] In some embodiments, the device 305 acts as an elastic protection mechanism to help keep the cervix closed until the onset of labor and to help prevent or delay premature birth.

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

[0406] Now referring to Figure 4A and 4B , Figure 4A and 4B are simplified cross-sectional views of a device for delaying childbirth placed around a cervix, according to an exemplary embodiment of the present invention.

[0407] Figure 4A and 4B show the device 400, 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 a 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 several arms.

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

[0411] Figure 4A and 4B Also shown is the approximate location of an internal os 406 of the cervix 404 and an external os 407 of the cervix 404.

[0412] In some embodiments, when the fetal head or 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 downward 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 pivot, causing the anchoring mechanism 403 to radially push inward and apply a 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 pivot, causing the anchoring element 403 to radially push inward and apply a 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 pivot, causing the anchoring element 403 to radially push inward and apply a force on the cervix 404.

[0416] In some embodiments, the upper ring 401 includes a spring that, in response to an opening force on the upper ring 401, applies a force to expand the upper ring 401, causing the anchoring element 403 to radially push inward and apply a force on the cervix 404.

[0417] Now referring Figures 5A to 5C , Figures 5A to 5C is a simplified diagram of a device for delaying childbirth, according to an exemplary embodiment of the present invention.

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

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

[0420] Figures 5A to 5C Shows that the device 500 includes an upper ring 501, and a plurality of anchoring elements 503 for anchoring the device 500 on the cervix,

[0421] Figures 5A to 5C Also shows an optional strip 502 for optionally preventing the plurality of anchoring elements 503 of the device 500 from radially expanding outward.

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

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

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

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

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

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

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

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

[0430] The device 500 is optionally 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), in a range from small, for example 10 mm or 20 mm, to larger, for example 40 mm, 50 mm, 60 mm, and greater.

[0432] Now refer to Figure 6A and 6B , Figure 6A and 6B which are simplified diagrams of a device for delaying childbirth according to an exemplary embodiment of the present invention.

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

[0434] Refer to Figure 6A and 6B , the term top view means a view in a direction from the uterus to the exit of the vagina, and the term bottom view means the opposite direction.

[0435] Figure 6A and 6B shows that the device 600 includes an upper ring 601 and a plurality of anchoring elements 603 for anchoring the device 600 to the cervix.

[0436] Figure 6A and 6B also shows an optional strip 602 for optionally preventing radial outward expansion of several elements of the anchoring mechanism 603 of the device 600.

[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] Now refer to Figure 7A and 7B , Figure 7A and 7B are images of several exemplary embodiments of several devices for delaying childbirth according to an exemplary embodiment of the present invention.

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

[0440] Refer to Figure 7A and 7B , the term top view means a view in a direction from the uterus to the vagina.

[0441] Figure 7A and 7B shows that the device 700 includes an upper ring 701 and a plurality of anchoring elements 703 for anchoring the device 700 to the cervix.

[0442] Figure 7A and 7B is intended to show that the spacing between the plurality of anchoring elements 703 for anchoring the device 700 to the cervix can be different in different embodiments.

[0443] Now refer to Figure 8A and 8B , Figure 8A and 8B are images of a device for delaying childbirth placed around a model of a cervix according to an exemplary embodiment of the present invention.

[0444] Figure 8A and 8B shows a device 800 surrounding or embracing a laboratory model 804 of a cervix.

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

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

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

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

[0449] Figures 9A to 9D shows several different embodiments of different anchoring elements 900, 910, 920, 930.

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

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

[0452] Figure 9A shows the anchoring element foot 903, having a single rectangular protrusion toward the cervix side.

[0453] Figure 9B shows the anchoring element foot 913, having a circular protrusion toward the cervix side.

[0454] Figure 9C shows the anchoring element foot 903, having two rectangular protrusions toward the cervix side.

[0455] Figure 9D shows the anchoring element foot 903, having a single hemispherical protrusion toward the cervix side, with the circular side of the hemisphere toward the cervix side.

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

[0457] In some embodiments, the protrusions of the several anchoring elements are designed to anchor on an inner lumen of the device against an outer surface of the cervix.

[0458] In some embodiments, the shape of the anchoring element designed to abut against an inner lumen of the device against the outer surface of the cervix is optionally designed to adhere with a biological adhesive and / or an adhesive, such as polysiloxane or other polymeric adhesives or glue.

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

[0460] In some embodiments, the shape of the anchoring element designed to abut against a surface of the vagina is optionally, by way of a non-limiting example, designed for friction by having multiple protrusions, by including several pins, by being adapted for adhesion, by using an adhesive, such as polysiloxane or other polymeric adhesives or glue, by having a rough surface and others.

[0461] Now refer to Figures 10A to 10E , Figures 10A to 10E which is a simplified diagram of a device for delaying childbirth according to an exemplary embodiment of the present invention.

[0462] Figure 10A A device 1000 is shown, including an upper ring 1001 and several anchoring elements 1003.

[0463] Figure 10A is an isometric top view, and with reference to Figure 10A , the term top view means a view in a direction from the uterus towards the vagina.

[0464] Figure 10A An optional strip 1002 is also shown, surrounding the device 1000 and optionally preventing the several elements of the anchoring mechanism 1003 of the device 1000 from expanding radially outwards.

[0465] Figure 10Ais an exemplary embodiment intended to show the (several) anchoring elements 1003, which include several slots 1004 for optionally allowing a needle and / or a suture (not shown in Figure 10A to pass through.

[0466] Figure 10B is an isometric bottom view opposite to Figure 10A direction.

[0467] Figure 10B shows the device 1000 with additional details on the several anchoring elements 1003.

[0468] Figure 10B shows a view of several internal elements of the several anchoring elements 1003 and a suture needle 1005 stored therein.

[0469] In some embodiments, the suture needle 1005 is optionally squeezed through one of the several slots 1004 to penetrate the 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, penetrates 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, squeezing the suture needle 1005 through a slot 1004 is optionally performed by a tool, optionally by a caregiver operating the tool.

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

[0473] Figure 10C shows the device 1000, including the upper ring 1001 and the several anchoring elements 1003.

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

[0475] Figure 10C Also shows the optional strip 1002.

[0476] Figure 10Cis intended to show the exemplary embodiment(s) of the anchoring element(s) 1003, and to show the suture needle 1005 passing through a first slot 1004 and the tip of the suture needle 1005 returning through a second slot 1004.

[0477] Figure 10D Shows the device 1000 with additional details of the anchoring element(s) 1003.

[0478] Figure 10D Is an isometric bottom view, in Figure 10C the opposite direction of.

[0479] Figure 10D Shows internal elements of the anchoring element(s) 1003, and a view of the suture needle 1005.

[0480] Figure 10D Shows an exemplary embodiment where the tip of the suture needle 1005 passes through the first slot 1004 and returns through the second slot 1004.

[0481] Figure 10E Shows internal elements of the anchoring element(s) 1003, and a view of the suture needle 1005 stored therein.

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

[0483] In some embodiments, the suture needle 1005 is optionally actuated by releasing a stopper 1009 that optionally blocks the movement of the suture needle 1005 until actuation. In some embodiments, the stopper 1009 is actuated by pressing a spring 1008 to release the suture needle 1005.

[0484] Figure 10E Shows and exemplary embodiment where a spring 1006 is included in the upper loop 1001.

[0485] Now referring to 11A to 11C, Figures 11A to 11C Is a simplified illustration of a device for delaying childbirth, according to an exemplary embodiment of the present invention.

[0486] Figures 11A to 11C Is a bottom view of a device 1100 for delaying childbirth.

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

[0488] Figures 11A to 11C Show that the device 1100 includes an upper ring 1101, a plurality of anchoring elements 1103, and an optional strip 1102.

[0489] Figure 11A Show that the device 1100 has a first diameter R1.

[0490] Figure 11B Show that the device 1100 has the same first diameter R1. Figure 11B Is a more simplified view showing the plurality of anchoring elements 1103 and a circular ring 1105 (present in the drawing but not necessarily present in the device 1100), the circular ring 1105 emphasizing the first diameter R1.

[0491] Figure 11C Show the device 1100 compressed to a second diameter R2. Figure 11C Show the plurality of anchoring elements 1103 and a smaller circular ring 1105B (present in the drawing but not necessarily present in the device 1100), the circular ring 1105B emphasizing the second diameter R2. Figure 11C Show an exemplary second diameter R2 that is smaller than the first diameter R1.

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

[0493] Now refer to Figure 12 , Figure 12 Is a simplified flowchart illustration of a method for delaying production according to another exemplary embodiment of the present invention.

[0494] Figure 12 The method of includes the steps of:

[0495] Provide a device for delaying production, the device forming a lumen (1202) for surrounding the cervix;

[0496] Insert the device into the vagina so that the lumen surrounds the cervix (1204);

[0497] Position the device so that the upper ring surrounds the cervix at a level in the fornix and adjacent to the internal os of the cervix (1206); and

[0498] Place the device so that the anchoring elements clamp the cervix (1208).

[0499] In some embodiments, the device includes:

[0500] An upper ring for surrounding the cervix; and

[0501] An anchoring mechanism for anchoring the device to the cervix.

[0502] In some embodiments, the device includes an optional strap that optionally prevents several elements of the anchoring mechanism from expanding radially outward.

[0503] In some embodiments, the method includes compressing the device to pass through a vaginal opening.

[0504] In some embodiments, the method includes releasing the compression of the device to assist the device in surrounding the cervix.

[0505] In some embodiments, positioning the device includes driving or pushing the device upward such that the upper ring surrounds the cervix at a level in the fornix and adjacent to the internal os of the cervix.

[0506] In some embodiments, the method includes expanding the device to assist the device in surrounding the cervix.

[0507] In some embodiments, the method includes releasing the expansion of the device.

[0508] In some embodiments, the method includes the anchoring mechanism clamping the cervix by pressing against the cervix.

[0509] In some embodiments, the anchoring method includes an adhesive such as silicone, some other polymeric adhesive, glue.

[0510] In some embodiments, the method includes the anchoring mechanism anchoring to the cervix by inserting at least one pin into the cervix.

[0511] In some embodiments, the method includes the anchoring mechanism passing a needle through the cervix tissue.

[0512] In some embodiments, the method includes suturing at least one of the anchoring elements to the cervix.

[0513] Now referring to Figure 13A and 13B , Figure 13A and 13B are simplified diagrams of a device for delaying childbirth according to an exemplary embodiment of the present invention

[0514] Figure 13A and 13BDisclosed is a device for delaying childbirth, the device comprising an upper ring 1301 for surrounding a cervix, a plurality of connectors 1304 for connecting the upper ring to a plurality of anchoring pads 1303, a spring 1305, a strap 1306 and a plurality of protrusions 1302.

[0515] In some embodiments, the spring 1305 is for pushing the upper ring 1301 and the plurality of anchoring pads 1303 and / or the strap 1306 apart.

[0516] 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 when the plurality of anchoring pads 1303, optionally as high as possible along the cervix, clamp the cervix.

[0517] In some embodiments, as the spring 1305 is released, the upper ring 1301 is pushed towards the top of the cervix against the anchoring of the plurality of anchoring pads 1303.

[0518] Now refer to Figure 13C and 13D , Figure 13C and 13D are simplified diagrams of a device for delaying childbirth according to an exemplary embodiment of the present invention.

[0519] Figure 13C and 13D Disclosed is a device for delaying childbirth, 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.

[0520] In some embodiments, the spring 1316 is for pushing the upper ring 1311 and the plurality of anchoring rings 1313, 1314 apart.

[0521] In some embodiments, the spring 1316 is held compressed when the device is inserted into a vagina and positioned to surround a cervix, and optionally released when the plurality of anchoring rings 1313, optionally as high as possible along the cervix, clamp the cervix.

[0522] In some embodiments, as the spring 1316 is released, the upper ring 1311 is pushed towards the top of the cervix against the anchoring of the plurality of anchoring rings 1313, 1314.

[0523] Now refer to Figures 13E to 13I , Figures 13E to 13Iis a simplified illustration of an apparatus for delaying childbirth, according to an exemplary embodiment of the present invention.

[0524] Figures 13E to 13I Shows an apparatus that includes an upper ring 1321 for surrounding an upper part of a cervix, and an anchoring mechanism for anchoring the apparatus to the cervix. The anchoring mechanism includes a plurality of legs 1323 for pressing against and clamping the cervix, a plurality of feet 1325, and a strap 1324 for pressing the plurality of feet against the cervix.

[0525] Figure 13E is an isometric top view, Figure 13F is an isometric bottom view, Figure 13G is a bottom view, Figure 13H is a top view and Figure 13I is a side view.

[0526] In some embodiments, one or more of the plurality of feet 1325 include an optional plate 1326 for hardening the plurality of feet 1325.

[0527] In some embodiments, one or more of the plurality of feet 1325 include an optional hole 1327 for connection to an insertion tool, and in some embodiments, for connection to a connection tool as described herein.

[0528] In some embodiments, the spacing of the plurality of feet 1325 includes some of the spacing between the plurality of feet 1325 that is greater than other spacing between the plurality of feet 1325.

[0529] In some embodiments, the larger spacing, by way of non-limiting example, is located at positions such as indicated by a plurality of arrows 1322.

[0530] In some embodiments, the plurality of larger spacings, by way of non-limiting example, are at "3 o'clock" and "9 o'clock".

[0531] In some embodiments, the apparatus includes a plurality of markers to potentially guide a physician to a desired orientation for placing the apparatus on the cervix.

[0532] In some embodiments, the plurality of markers, by way of non-limiting example, are located at "12 o'clock" and "6 o'clock", at positions indicated by a plurality of arrows 1328.

[0533] In Figures 13E to 13I the embodiment shown optionally in reference to Figure 2 and 5AThe several embodiments shown and described herein with reference to 5C share features.

[0534] Reference is now made Figures 13J to 13M , Figures 13J to 13M which is a simplified illustration of an apparatus for delaying labor, according to an exemplary embodiment of the present invention.

[0535] Figures 13J to 13M shows an apparatus that includes an upper ring 1331 for surrounding an upper portion of a cervix and an anchoring mechanism for anchoring the apparatus to the cervix. The anchoring mechanism includes several legs 1333, several feet 1335 for pressing against and clamping the cervix, and a strap 1334 for pressing the several feet against the cervix.

[0536] Figure 13J is an isometric view, Figure 13K is a bottom view, Figure 13L is a top view, and Figure 13M is a side view.

[0537] In some embodiments, one or more of the several feet 1335 include an optional plate 1336 to harden the several feet 1335.

[0538] In some embodiments, one or more of the several 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.

[0539] In some embodiments, the upper ring 1331 is constructed to grip a cervix (not shown) at several segments of a circumference of the cervix, leaving other segments of the circumference of the cervix without a pressing element, potentially relaxing blood flow in the cervix and potentially relaxing venous blood flow that is close to a surface of the cervix.

[0540] Figures 13J to 13M shows a non-limiting exemplary embodiment where several protrusions 1332 optionally project into a lumen or space in the upper ring 1331. In some embodiments, the number of the several protrusions can be 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or even greater.

[0541] In some embodiments, the upper ring 1331 is not necessarily a ring and can be referred to as an upper element 1331. The upper element 1331 defines an internal lumen for clamping and pressing against a specific segment of the cervix and leaving other segments free from pressure, potentially relaxing blood flow through at least the free segments.

[0542] In some embodiments, the upper element 1331 includes several protrusions, such as several projections 1332 for pressing on the cervix.

[0543] 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-point star (not shown).

[0544] In Figures 13J to 13M the embodiments shown are optionally shared with several features of the embodiments shown and described with reference to Figures 13E to 13I , Figure 2 and Figures 5A to 5C and several features are shared among several embodiments shown and described.

[0545] Now refer to Figure 14A and 14B , Figure 14A and 14B which are simplified diagrams of a cervix clamping tool according to an exemplary embodiment of the present invention.

[0546] Figure 14A and 14B show a tool 1400 for clamping a cervix, the tool including two jaws 1411, 1412 and a pivot 1410 connecting the two jaws 1411, 1412.

[0547] Figure 14A shows the tool 1400 in a jaw closed position, and Figure 14B shows the tool 1400 in a jaw open position.

[0548] In some embodiments, the clamping tool 1400 optionally includes additional pivots 1409a, 1409b connected by a pivot 1402 and connected to several extended handles 1406, 1407. The optional extended handles 1406, 1407 potentially allow the tool 1400 to be used from a location further away from the cervix to be clamped. The several optional extended handles 1406, 1407 optionally allow the tool 1400 to be used from a location further away from the vagina where the tool is inserted to clamp the cervix.

[0549] In some embodiments, the tool 1400 optionally includes a scale 1408. The scale optionally indicates a degree to which the plurality of jaws 1411, 1412 are opened. In various embodiments, the scale indicates the degree to which the plurality of jaws 1411, 1412 are opened by one or more of the following: indicating a distance, indicating an angle, indicating a corresponding dimension of a suitable device for a device for delaying production, indicating a corresponding dimension of one or more elements of 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.

[0550] In some embodiments, the tool 1400 optionally includes a spring for pushing apart the plurality of extended handles 1406, 1407, and a release control lever 1404. In some embodiments, the release control lever 1404 optionally acts on a tooth rack 1408 (where the pin 1405 is an optional end of a travel stopper), releasing the plurality of extended handles 1406, 1407 to separate, and the plurality of jaws 1411, 1412 to open.

[0551] In some embodiments, the control lever 1404 is optionally slid forward or backward to operate the plurality of jaws 1411, 1412.

[0552] Now refer Figures 14C to 14E , Figures 14C to 14E is a simplified illustration of a cervical clamp tool, according to an exemplary embodiment of the present invention.

[0553] Figure 14C and 14D show a tool 1420 for clamping the cervix, the tool including two jaws 1428, 1429, a pivot 1427 connecting the two jaws 1428, 1429, an extension tube 1424, and one or more controllers 1422, 1423, 1425.

[0554] Figure 14E shows the tool 1420 without the extension tube 1424 to expose several internal parts of the tool 1420.

[0555] Figure 14C and 14E shows the tool 1420 in a jaw closed position, and Figure 14D shows the tool 1420 in a jaw open position.

[0556] A first controller, and optionally a button 1425, is optionally used to open and close the jaws 1428, 1429 by pushing a rod 1430 into the tube 1424 (open) or pulling the rod out of the tube 1424 (closed).

[0557] 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 resists the spring to open the jaws 1428, 1429, and the rod 1430 is released to close the jaws 1428, 1429.

[0558] In some embodiments, the tool 1420 optionally includes a grip 1423 for use when the button 1425 is pressed.

[0559] In some embodiments, the tool 1420 optionally includes a latch 1422 that is optionally used against a ratchet 1421 to lock and / or release the movement of the rod 1430 along the tube 1424 and to open and / or close the jaws 1428, 1429.

[0560] Figure 14C A non-limiting example of a rod 1430 is shown, where several segments are connected by several hubs 1432. In some embodiments, the tool can be bent to enter a body via the vagina and clamp a cervix. In some embodiments, the tube 1424 can be elastic.

[0561] Now referring Figures 15A to 15D , Figures 15A to 15D is a simplified diagram of an insertion tool for inserting a device for delaying childbirth, according to an exemplary embodiment of the present invention.

[0562] Figures 15A to 15D An insertion tool 1500 for inserting a device 1502 for delaying childbirth is shown.

[0563] Figure 15A And 15B shows the device 1502 for delaying childbirth mounted to a distal end of the insertion tool 1500.

[0564] The insertion tool 1500 includes several rods 1504 and several rings 1503 to which the several rods 1504 are connected, forming the shape of a lumen surrounded by the several rods 1504.

[0565] The device 1502 can optionally be connected to a distal end of the several rods 1504.

[0566] 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).

[0567] 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 Figure 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.

[0568] In some embodiments, the shape of the lumen surrounded by the plurality of rods 1504 is optionally transformed from a circle to an ellipse.

[0569] 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.

[0570] In some embodiments, the insertion tool includes one or more of the following:

[0571] 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;

[0572] 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 . Figure 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.

[0573] In some embodiments, an optional button 1509 allows for fine adjustment of the device at a position within the vault. For example, by pressing each of the several buttons 1509 separately, the several rods each push the device at a different position, potentially allowing placement within the vault completely around the cervix.

[0574] An optional clamp 1507 for the insertion tool 1500, and

[0575] An optional control lever 1506 having a pivot 1513 that, when squeezed, longitudinally moves the several rods 1504 and changes a cross-sectional shape of the lumen formed by the several rods 1504.

[0576] Figure 15C Shows that when the button 1508 is optionally pulled backward, the cup 1514 or pin is optionally pulled backward along the several rods 1504, releasing a distal end of the several rods for connecting the device 1502 (not shown in Figure 15C )

[0577] Figure 15D Shows that when the handle 1508 is optionally slid backward along the several rods 1504, the cup 1514 or pin optionally pushes the device 1502 (not shown in Figure 15D ) away from a distal end of the several rods 1504.

[0578] Now refer to Figure 16A and 16B , Figure 16A and 16B which are simplified diagrams of the insertion tool for preparing to insert a device for delaying childbirth and a clamping tool for clamping a cervix, according to an exemplary embodiment of the present invention. Figure 15A and 15B

[0579] Figure 16A is a cross-sectional side view, and Figure 16B is an isometric view.

[0580] Additional reference is made to Figure 16C , Figure 16C which is a simplified diagram of the insertion tool for inserting a device for delaying childbirth and the clamping tool for clamping a cervix, according to an exemplary embodiment of the present invention. Figure 15A and 15B Figure 16A

[0581] Figures 16A to 16CShown is an insertion tool 1604, a device 1602 for delaying delivery is coupled to the insertion tool 1604, and a clamping tool 1606, for example, in a non-limiting example, Figure 14A and 14B the clamping tool 1400 of Figure 14C and 14D the clamping tool 1420 of

[0582] Figure 16A and 16B Shown, in a non-limiting example, as they would be assembled, the insertion tool 1604, the device 1602, and the clamping tool 1606 are assembled before being inserted into a vagina.

[0583] 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.

[0584] In some embodiments, the assembly of the insertion tool 1604, the device 1602, and the clamping tool 1606 is optionally inserted via a speculum.

[0585] In some embodiments, a control lever 1608 of the insertion tool 1604 is optionally squeezed, optionally by operating a control lever 1608, and the cross-sectional area of the insertion tool is optionally reduced before inserting the assembly of the insertion tool 1604, the device 1602, and the clamping tool 1606 into a vagina.

[0586] Figure 16C Shown as they would be in a vagina, the insertion tool 1604, the device 1602, and the clamping tool 1606, wherein the insertion tool 1604 is in an uncompressed state, and the clamping tool clamps a cervix 1610.

[0587] Now referring to Figure 16D , Figure 16D is of an exemplary embodiment of the present invention, having a clamping tool pulling a cervix into a device for delaying delivery, Figures 16A to 16C a simplified diagram of the insertion device of

[0588] Figure 16D Shown is the clamping tool 1606 clamping the cervix 1610, and optionally pulling the cervix 1610, optionally positioning the device 1602 for delaying delivery above the cervix 1610. Figure 16D Shown is the clamping tool 1606 being pulled back relative to the insertion tool 1604.

[0589] After positioning the device 1602 for delaying delivery on the cervix 1610, a mechanism for separating a device 1602 for delaying delivery from the insertion tool 1604 is optionally operated to separate the device 1602.

[0590] In some embodiments, operating the mechanism for separating the device 1602 optionally includes pressing one or more of the buttons 1612.

[0591] In some embodiments, operating the mechanism for separating the device 1602 optionally includes operating a handle 1614.

[0592] 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 connected to the optional grip 1507 and are not designed to be pushed forward. The other four rods can be pushed forward. Such a configuration potentially allows the device 1502 to be accurately and highly positioned around the cervix in a manner that potentially positions an upper loop of the device 1502 in the fornix and potentially contacts the tissue around the fornix.

[0593] Now referring Figure 16E , Figure 16E is a simplified illustration of the insertion tool separated from a device for delaying delivery, according to an exemplary embodiment of the present invention. Figures 16A to 16C of the insertion tool.

[0594] Figure 16E Shows the distal ends 1616 of the insertion tool 1604 separated from the device 1602.

[0595] Figure 16E The cervix clamping tool 1606 is not shown. In some embodiments, the cervix 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 cervix clamping tool 1606 is optionally withdrawn from the insertion tool 1604 after the device 1602 is separated from the insertion tool 1604.

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

[0597] In some embodiments, the cervical clamp tool 1606 is withdrawn from the vagina before the insertion tool 1604 is withdrawn from the vagina and after the insertion tool 1604 is detached from the device 1602.

[0598] In some embodiments, the cervical clamp tool 1606 and the insertion tool 1604 are withdrawn from the vagina together.

[0599] Now refer to Figure 16F , Figure 16F is a simplified flowchart of a method for placing a device for delaying childbirth on a cervix according to an exemplary embodiment of the present invention.

[0600] The cervix can sometimes be at a forward, a backward, a left-tilted or a right-tilted angle.

[0601] In some embodiments, a clamp tool is optionally used to clamp the cervix and position the cervix centrally to allow for good placement of the device.

[0602] In some embodiments, an insertion tool can optionally include a scope that allows the insertion process to be visualized on a screen, at a proximal end of the insertion tool and / or on an external screen. The use of a screen potentially allows for good visualization of the cervix and the insertion process.

[0603] In some embodiments, a method for placing a device for delaying childbirth on a cervix optionally includes:

[0604] Connecting a device for delaying childbirth to an insertion tool (1632);

[0605] Using a cervical clamp tool to clamp the cervix (1634);

[0606] Inserting the insertion tool surrounding the cervical clamp tool into the vagina (1636).

[0607] Positioning the device on the cervix (1638);

[0608] Releasing the insertion tool from the device (1640);

[0609] Withdrawing the clamp tool from the vagina (1642); and

[0610] Withdrawing the insertion tool from the vagina (1644).

[0611] In some embodiments, before connecting the device to the insertion tool, the cervical clamp tool is optionally inserted into the vagina and the diameter of the cervix is optionally measured.

[0612] In some embodiments, optionally based on the measurement, a correct size of a device for delaying production is optionally selected.

[0613] In some embodiments, the device is optionally connected to the placement tool having optional markings at 12 o'clock and at 6 o'clock.

[0614] In some embodiments, on both sides of the cervix, optionally at 3 o'clock and 9 o'clock, the clamping of the cervix by the cervix clamping tool is performed.

[0615] In some embodiments, the clamping of the cervix is optionally performed after the placement tool surrounding the cervix clamping tool is placed into the vagina.

[0616] In some embodiments, the placement of the placement tool and / or the clamping tool is accomplished via a speculum.

[0617] In some embodiments, after the device is positioned on the cervix, the position of the device is optionally adjusted by pressing the ends of the several rods. The device is optionally positioned in the fornix.

[0618] In some embodiments, the withdrawal of the clamping tool from the vagina is performed together with the withdrawal of the placement tool from the vagina.

[0619] In some embodiments, the withdrawal of the clamping tool from the vagina is performed before the withdrawal of the placement tool from the vagina.

[0620] In some embodiments, the withdrawal of the placement tool from the vagina is performed before the withdrawal of the clamping tool from the vagina.

[0621] In some embodiments, such as in the example shown in Figures 16A to 16E In the placement tool 1500, there are six rods 1504. In some embodiments, the several rods at 12 o'clock and 6 o'clock are optionally connected 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 accurately and highly positioning the device 1502 around the cervix in a manner that potentially positions an upper loop of the device 1502 in the fornix and potentially contacts the tissue around the fornix.

[0622] Now referring to Figures 17A to 17C , Figures 17A to 17C is a simplified diagram of a device for delaying production placed around a cervix according to an exemplary embodiment of the present invention.

[0623] Figures 17A to 17C Displays a device for delaying childbirth placed around a cervix 1710, and also displays the vaginal wall 1712. The cervix 1710 is optionally in a state corresponding to pregnancy and not yet in labor or childbirth.

[0624] Figure 17A is a lateral cross-sectional view, Figure 17B is an isometric bottom view and Figure 17C is a bottom view.

[0625] Figures 17A to 17C Displays a device for delaying childbirth, including an upper ring 1702 placed around the cervix 1710, several legs 1704 and several feet 1706 surrounded by a strap 1708. The strap 1708 presses on the several legs 1704, pressing the several feet 1706 against the cervix 1710.

[0626] The device for delaying childbirth presses on the cervix 1710 and potentially helps to keep the cervix support a fetus and potentially delays the funneling and / or dilation of the cervix, and / or premature labor and / or early childbirth.

[0627] However, labor or childbirth may start, and in some embodiments, the device for delaying childbirth is optionally configured to support the cervix until a specific time point, then yield, release the cervix and allow the childbirth to occur. In some embodiments, the "yielding" is by the device flipping, the upper ring releasing the cervix and / or the several anchors releasing the cervix.

[0628] Now refer to Figures 18A to 18C , Figures 18A to 18C is according to an exemplary embodiment of the present invention, several simplified diagrams of a device for delaying childbirth placed around the cervix when the cervix is under pressure.

[0629] Figures 18A to 18C Displays a device for delaying childbirth placed around a cervix 1810 when the cervix 1810 is under pressure, and also displays the vaginal wall 1812. The cervix 1810 is optionally in a state under pressure from above, and the device has not been released from the cervix 1810.

[0630] Figure 18A is a cross-sectional side view, Figure 18B is an isometric bottom view and Figure 18C is a bottom view.

[0631] Figures 18A to 18CDisclosed is a device for delaying childbirth, including an upper ring 1802 placed around the cervix 1810, several legs 1804 surrounded by a strap 1808, and several feet 1806. The strap 1808 presses on the several legs 1804, pressing the several feet 1806 against the cervix 1810.

[0632] However, the cervix 1810 is in a more dilated state than the cervix 1710 shown in Figures 17A to 17C . The upper ring 1802 is more dilated, the top of the several legs 1804 is laterally extended, and the several legs are more inward, toward the center of a lumen defined by the shape of the device.

[0633] In some embodiments, under additional pressure from the cervix 1810, the device flips, and optionally, the upper ring 1802 flips the strap 1808 and the several feet of the several legs 1806 in a direction indicated by arrow 1814.

[0634] It should be noted that the pressure can come from the uterus. This pressure can cause the dilation of the internal orifice of the cervix and such pressure potentially affects the upper ring of the device.

[0635] Now refer to Figure 18D and 18E , Figure 18D and 18E are simplified diagrams of a device for delaying childbirth after inversion on a cervix according to an exemplary embodiment of the present invention.

[0636] Figure 18D is a cross-sectional side view and Figure 18E is a bottom view.

[0637] Figure 18D and 18E show a device for delaying childbirth, including an upper ring 1802 placed around the cervix 1810, several legs 1804, several feet 1806, and a strap 1808.

[0638] The device has been flipped, and for example, in Figure 18A , the several feet 1806 press against one side of the cervix 1810 and now point outward, not against the cervix.

[0639] In some embodiments, the several feet 1806 no longer anchor the device to the cervix.

[0640] In some embodiments, the pressure exerted by the cervix on the device is sufficient to flip the device and sufficient to cause the device to slide down the cervix.

[0641] Now refer to Figure 19 , Figure 19 which is a simplified method for delaying childbirth according to an exemplary embodiment of the present invention.

[0642] Figure 19 The method of

[0643] provides a device for delaying childbirth, the device forming a lumen (1902) for surrounding the cervix;

[0644] places the device in a vagina such that the lumen surrounds the cervix (1904);

[0645] positions the device such that the upper ring surrounds the cervix in a fornix at a level at the internal os of the cervix (1906); and

[0646] places the device such that the device clamps the cervix (1908).

[0647] Now refer to Figure 20 , Figure 20 which is a simplified method for delaying childbirth according to an exemplary embodiment of the present invention.

[0648] Figure 20 The method of

[0649] provides an insertion tool and a device (2002) for delaying childbirth coupled to a distal end of the insertion tool;

[0650] inserts the distal end of the insertion tool into the vagina (2004);

[0651] manipulates the insertion tool such that the device surrounds the cervix (2006);

[0652] detaches the device from the insertion tool, leaving the device clamping the cervix (2008); and

[0653] withdraws the insertion tool from the vagina (2010).

[0654] In some embodiments, positioning the device such that the upper ring surrounds the cervix in a fornix at a level at the internal os of the cervix means positioning the device such that the upper ring surrounds the cervix in a fornix within about 0 to 10, 15, 20, 25, 30, 40, and 50 millimeters, for example 5 millimeters, of the level at the internal os of the cervix.

[0655] As used herein, the term "about" means ±10%.

[0656] The terms "comprising", "including", "having", and the like, and variations thereof, mean "including but not limited to".

[0657] "Consisting of" is intended to mean "including and limited to".

[0658] "Consisting essentially of" means that a composition, method, or structure may include additional ingredients, steps, and / or parts only if the additional ingredients, steps, and / or parts do not materially alter the basic and novel characteristics of the claimed composition, method, or structure.

[0659] As used herein, the singular forms "a", "an", and "the" include plural referents unless the context clearly dictates otherwise. For example, "a component" or "at least one component" may include several components, including combinations thereof.

[0660] The terms "example" and "exemplary" are used herein to mean "serving as an example, illustration, or instance". Any embodiment described as an "example" or "exemplary" is not necessarily to be construed as preferred or superior to other embodiments and / or does not preclude the incorporation of features from other embodiments.

[0661] The term "optional" is used herein to mean "provided in some embodiments and not provided in other embodiments". Any particular embodiment of the invention may include several "optional" features, unless such features are mutually conflicting.

[0662] Throughout this application, various embodiments of the invention may be presented in a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the invention. Accordingly, a description of a range should be considered to have specifically disclosed all the possible sub-ranges as well as individual numerical values within that range. For example, a description of a range such as from 1 to 6 should be considered to have specifically disclosed 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., as well as individual numbers within that range, for example 1, 2, 3, 4, 5, and 6. This applies regardless of the width of the range.

[0663] Whenever a numerical range is indicated herein, the numerical range is intended to include any recited number (fractional or integral) within the indicated range. The terms “between” a first recited number and a second recited number, and “from” a first recited number “to” a second recited number are used interchangeably herein and are intended to include the first and second recited numbers and all fractional and integral numbers therebetween.

[0664] As used herein, the term “method” means a method, means, technique and procedure for accomplishing a given task, including but not limited to methods, means, techniques and procedures known to practitioners of the arts of engineering, chemistry, pharmacy, biology, biochemistry and medicine and methods, means, techniques and procedures readily developed therefrom.

[0665] As used herein, the term “treatment” 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 appearance of the clinical or sensory symptoms of a disorder.

[0666] It should be understood that specific features of the invention that are described in the context of separate embodiments for 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 brevity may also be provided separately or in any suitable subcombination in any other described embodiment of the invention. Specific embodiments described in the context of various embodiments are not to be considered essential features of those embodiments unless the embodiment cannot operate without those features.

[0667] Although the invention has been described in connection with its specific embodiments, it is apparent that many alternatives, modifications and variations will be apparent to those of ordinary skill in the art. Accordingly, the invention is intended to embrace all such alternatives, modifications and variations that fall within the spirit and scope of the appended claims.

[0668] All publications, patents and patent applications mentioned in this specification are incorporated herein by reference in their entirety to the same extent as if each individual publication, patent and patent application were specifically and individually indicated to be incorporated herein by reference. In addition, the citation or identification of any reference in this application should not be construed as an admission that such reference may be prior art to the present invention. Where paragraph headings are used, they should not be considered necessarily limiting.

[0669] In addition, any (multiple) priority documents of this application are incorporated herein by reference in their entirety.

Claims

1. An insertion tool for inserting a device for delaying childbirth, Characterized in that: The device includes a device lumen for surrounding a cervix, and the insertion tool includes: Several rods, connected to at least two rings, forming a longitudinal tool lumen, and each rod includes: 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.

2. The insertion tool according to claim 1, Characterized in that: The several rods are elastically connected to the several rings, allowing the cross-section of the longitudinal tool lumen to expand and contract.

3. The insertion tool according to claim 1, Characterized in that: The several rings are elastic, allowing the cross-section of the longitudinal tool lumen to expand and contract.

4. The insertion tool according to claim 1, Characterized in that: Further includes a control rod for moving the several rods closer to each other, thereby reducing the cross-section of the tool lumen.

5. The insertion tool according to claim 4, Characterized in that: Moving the several rods changes the angle at which the several rods are connected to the device for delaying childbirth.

6. The insertion tool according to claim 2, Characterized in that: The control rod for moving the several rods closer to each other causes one or more rods to move longitudinally relative to one or more other rods, thereby forming an elliptical cross-section of the tool lumen.

7. The insertion tool according to claim 4, Characterized in that: The several rods are configured to move away from each other, thereby expanding the cross-section of the tool lumen and expanding the connected device for delaying childbirth.

8. The insertion tool according to claim 1, Characterized in that: The several rods include several channels along the several rods for applying an adhesive material to a device for delaying childbirth.

9. The insertion tool according to claim 1, Characterized in that: The insertion tool is configured to separate from all connection positions with the device for delaying childbirth.

10. The device according to claim 1, Characterized in that: When the device for delaying childbirth is separated from the several rods, the device still clamps the cervix.

11. The device according to claim 1, Characterized in that: The device includes: An upper ring for surrounding the cervix; and An anchor for anchoring the device to the cervix, Wherein The anchor includes several legs, the several legs are connected to the upper ring at one end, and the several legs are configured to be anchored to the cervix at the lower other end.

12. The device according to claim 11, Characterized in that: The inner diameter of the upper ring is greater than the inner diameter of the anchor, and the device further includes a pivot position, so that when an axial force is applied to the upper ring, towards the anchor, the force will push the anchor towards the cervix.

13. The device according to claim 11, Characterized in that: Further includes a band surrounding the anchoring mechanism.

14. The device according to claim 11, Characterized in that: The anchoring element includes a foot having a protrusion facing the cervix side, and the protrusion has a shape selected from the group consisting of: A single rectangular protrusion facing the cervix side; A spherical protrusion facing the cervix side; Two rectangular protrusions facing the cervix side; and A hemispherical protrusion with the circular side facing the cervix side.

15. The device according to claim 11, wherein: The upper ring includes several gaps on the inner side of the upper ring, such that the several gaps do not compress the cervix.

16. The device according to claim 1, wherein: The device includes: An upper ring for surrounding the cervix; An anchoring mechanism for anchoring the device to the cervix; and A pivot position configured such that when an axial force is applied to the upper ring towards the anchor, the force pushes the anchor towards the cervix.

17. The device according to claim 16, wherein: The pivot mechanism includes a band surrounding the anchoring mechanism.

18. A clamping tool for clamping a cervix, wherein: The clamping tool includes: Several jaws for clamping a cervix; A pivot connecting the several jaws, enabling the several jaws to separate and close from each other; An extension tool connected to the several jaws; and Several controllers for opening and closing the several jaws, wherein the several jaws are configured to expand to a width greater than 4 times the width of the extension tool.

19. The clamping tool according to claim 18, wherein: The several controllers are configured to linearly move along the direction of the axis of the extension tool when opening and closing the several jaws.

20. The clamping tool according to claim 18, wherein: The clamping tool includes several wheels for pulling the cervix into the several jaws of the clamping tool.

21. A device for delaying childbirth, wherein: Forming a lumen for surrounding a cervix, the device includes: An upper ring for surrounding the cervix; and An anchor for anchoring the device to the cervix, wherein The anchor includes several legs, the several legs are connected to the upper ring at one end, and the several legs are configured to be anchored to the cervix at the lower other end.

Images