WO2019186414A1 - Dilatateur cervical - Google Patents

Dilatateur cervical Download PDF

Info

Publication number
WO2019186414A1
WO2019186414A1 PCT/IB2019/052472 IB2019052472W WO2019186414A1 WO 2019186414 A1 WO2019186414 A1 WO 2019186414A1 IB 2019052472 W IB2019052472 W IB 2019052472W WO 2019186414 A1 WO2019186414 A1 WO 2019186414A1
Authority
WO
WIPO (PCT)
Prior art keywords
cervical
tube
dilator
catheter
cervical tube
Prior art date
Application number
PCT/IB2019/052472
Other languages
English (en)
Inventor
Meir POMERANZ
Original Assignee
Mor Research Applications Ltd.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Mor Research Applications Ltd. filed Critical Mor Research Applications Ltd.
Publication of WO2019186414A1 publication Critical patent/WO2019186414A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/42—Gynaecological or obstetrical instruments or methods
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M29/00—Dilators with or without means for introducing media, e.g. remedies
    • A61M29/02—Dilators made of swellable material
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/42—Gynaecological or obstetrical instruments or methods
    • A61B2017/4216—Operations on uterus, e.g. endometrium
    • A61B2017/4225—Cervix uteri
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/1002—Balloon catheters characterised by balloon shape

Definitions

  • the present invention relates to a system and method for labor induction.
  • Inducing labor is the artificial start of the birth process through medical interventions or other methods. There are various reasons to induce labor. For example, when a woman is two or more weeks overdue, and labor does not start on its own, it may be desirous to induce labor, due to fetal or maternal indications, such as placental dysfunction, pregnancy induced hypertension, preeclampsia, diabetes, intra-uterine growth restriction, and/or other conditions that may jeopardize fetal well-being, or adversely affect the woman's health.
  • fetal or maternal indications such as placental dysfunction, pregnancy induced hypertension, preeclampsia, diabetes, intra-uterine growth restriction, and/or other conditions that may jeopardize fetal well-being, or adversely affect the woman's health.
  • the ability to induce labor is dependent on the favorability of the cervix to dilate.
  • the cervix or cervix uteri is the lower part of the uterus in the human female reproductive system. In a non-pregnant woman, the cervix is usually 2 to 3 cm long and roughly cylindrical in shape. The narrow, central cervical canal runs along its entire length, connecting the uterine cavity and the lumen of the vagina. The opening into the uterus is called the internal orifice or os, and the opening into the vagina is called the external os.
  • the Foley catheter with a 30 ml balloon is a cheap and simple catheter that is traditionally used for emptying urine bladders, but is also frequently used to mechanically dilate a cervix.
  • This catheter is placed into the cervix and once the balloon is in the uterus and just past the cervix it is inflated with 50-60 ml of sterile water or normal saline. The catheter is then pulled tight and secured to the patient's thigh, and when it falls out the patient's cervix may be 4-5 cm dilated.
  • Another catheter example is the Cook" Cervical Ripening Balloon. It is a two balloon catheter that is placed such that one balloon is in the uterus, and the other balloon is in the vagina. Each balloon is separately connected to flexible tubing, permitting independent filling or emptying of each balloon.
  • This catheter is placed into the cervix and once both balloons have entered the cervical canal the uterine balloon is inflated with 40 ml of saline. After the uterine balloon is inflated, the device is pulled back until the balloon abuts the internal cervical os. Then the vaginal balloon is inflated with e.g., 20 mL of saline.
  • saline is added to a maximum of, e.g., 80 mL per balloon.
  • the embodiments of the medical device aim to provide an effective and safe method and device for dilating a cervix.
  • a cervical dilator catheter is provided.
  • Example 1 includes a cervical dilator catheter comprising a hollow cervical tube or catheter comprising a proximal catheter (also: cervical tube) end and a distal catheter (also: cervical tube) end; an expandable body extending from the distal catheter end; an applicator body mounted on the cervical tube; and a convex-shaped head connected to the stem.
  • the convexshaped head is operable to engage an external os.
  • distal refers to a location which is further away from a medical professional operating the system compared to a "proximal” location.
  • the applicator body may be bulb-shaped.
  • the applicator body may be rigid or semi-rigid.
  • at least some of the outer surface of applicator body may be smooth allow sliding of the outer surface into the patient's cervix in a manner that minimizes risk of damage, injury and/or trauma to cervical tissue.
  • the entire outer surface of applicator body may be smooth.
  • at least a portion of the outer surface of applicator body may be free of ridges, grooves, protrusions and/ or any other surface patterning to minimize risk of damage, injury and/or trauma to cervical tissue when forcing the applicator body to slide towards expandable body.
  • no twisting motion of the applicator body is required for the anchoring thereof relative to the cervix.
  • the applicator body may comprise a proximal stem and a convex-shaped head positioned distally to the proximal stem such that the convex-shaped head faces the distal catheter end.
  • the catheter may be configured to allow a user thereof to controllably perform: expanding the expandable body; maintaining the expandable body in an expanded state; contracting the expandable body, and moving the applicator body towards the distal catheter end by pushing the stem towards the distal catheter end.
  • Example 2 the subject matter of Example 1 optionally includes wherein the catheter is further configured to allow locking and unlocking the applicator body, the locking essentially preventing the applicator body (or the optionally convex-shaped head thereof) from moving towards the distal catheter end.
  • Example 3 the subject matter of Example 2 optionally includes wherein the catheter further comprises a manually operable lever; wherein the cervical tube comprises a plurality of teeth arranged essentially in a line in a direction of the longitudinal axis of the cervical tube; wherein the lever is disposed on the line, and wherein the locking comprises engaging the lever with a tooth from the plurality of teeth, and the unlocking comprises disengaging the lever from the tooth from the plurality of teeth.
  • Example 4 the subject matter of example 3 optionally includes wherein the teeth are blunt.
  • Example 5 the subject matter of example 3 or 4 optionally includes wherein the teeth are crenated.
  • Example 6 the subject matter of any one of example 3 to 5 optionally includes wherein the lever is operable by finger action; wherein the catheter further comprises a rail mounted on the cervical tube, the rail essentially parallel to a longitudinal axis of the cervical tube; wherein the applicator body has a slot extending therethrough, and wherein the slot and rail are aligned and conform to each other to allow the moving of the applicator body towards the distal catheter end, and restricting rotation of the applicator body around the cervical tube when the slot is engaged with the rail.
  • Example 7 the subject matter of any one of the examples 1 to 6 optionally includes wherein the catheter further comprises a stopper delimiting the moving of the applicator body towards the distal catheter end.
  • Example 8 the subject matter of any one of the Examples 1 to 7 optionally includes a hollow first inner tube, extending from outside the proximal end, within the cervical tube to the expandable body, wherein the expandable body is expandable with fluid by passing the fluid from outside the proximal end, through the first inner tube and into the expandable body.
  • Example 9 the subject matter of any one of the Examples 1 to 8 optionally includes a hollow second inner tube, extending from outside the proximal end, within the cervical tube to outside the distal end, and wherein the catheter is configured to allow receiving fluids from outside the distal end, via the second inner tube to outside the proximal end.
  • Example 10 the subject matter of any one of the Examples 1 to 9 optionally includes a soft nipple, sealing the distal end.
  • Example 11 the subject matter of any one of the Examples 1 to 10 optionally includes a hollow second inner tube, extending from outside the proximal end, throughout the cervical tube and the nipple, wherein the catheter is configured to allow receiving fluids from outside the distal end, via the second inner tube to outside the proximal end.
  • Example 12 the subject matter of any one of the Examples 1 to 11 optionally includes wherein the applicator (e.g., bulb-shaped) body has a diameter ranging from about 3 to 6cm at widest part thereof.
  • the applicator e.g., bulb-shaped
  • Example 13 the subject matter of any one of the Examples 1 to 12 optionally includes wherein the applicator body has a diameter ranging from about 4 cm to about 5 cm at widest part thereof.
  • Example 14 the subject matter of any one of the Examples 1 to 13 optionally includes wherein the expandable body and/or the tube and/or the applicator body are essentially transparent.
  • Example 15 the subject matter of any one of the Examples 1 to 14 optionally includes wherein the external os applicator body and/or the expandable body comprises one or more material selected from a group consisting of: polypropylene, polyethylene, and polycarbonate.
  • Example 16 the subject matter of any one of the Examples 3 to 6 optionally includes wherein the stem comprises a plurality of ribs; the lever is disposed in between adjacent ribs of the plurality of ribs, and the adjacent ribs are spaced at least 2.5 cm apart.
  • Example 17 the subject matter of Example 16 optionally includes wherein the adjacent ribs are spaced 3 cm to 4 cm apart.
  • Example 18 the subject matter of any one of the Examples 1 to 17 optionally includes wherein the convex-shaped head is one of dome-shaped, frustro-conical-shaped or sphericalshaped.
  • the applicator body may have a biconvex-shaped head.
  • the convex-shaped head may have a convex-curved (e.g., spherical) geometry.
  • the applicator body may have a tapered (e.g., conical) geometry, tapering in distal direction.
  • the applicator body may have a double-cone shape or a double-frustro-cone shape, or any other suitable geometry.
  • the convex-shaped head is slidably coupled to the catheter.
  • an expandable body may be employed, which can be implemented as balloons as described herein.
  • Such expandable body can be controllably expanded and contracted.
  • the expandable body When in an expanded state, the expandable body may be shaped such that the expandable body conformably lies or abuts against both the inner os and/or the fetus' head, for example.
  • the expandable body when in the expanded state, may have a non- spherical shape.
  • the expandable body when in the expanded state, may have a generally ellipsoidal or otherwise comparatively flat shape.
  • patient may refer to any animal, particularly humans.
  • the term "medical device” means any object that is itself or that includes, for example, a component that engages with a patient.
  • the medical device can, for example, be intentionally inserted into the body of a patient as part of a medical treatment.
  • the medical device can include a structure adapted for introduction into a patient.
  • the medical device can be a tool, such as, without limitation, a catheter, a wire guide, forceps, or scissors used to affect a surgical procedure at and/or deliver a second medical device to a treatment site in a patient.
  • proximal and distal will be used to describe the opposing axial ends of the assembly, as well as the axial ends of various components thereof.
  • proximal /"anterior
  • distal /"posterior
  • proximal /"anterior
  • Figure 1 schematically illustrates in a side-view a cervical catheter that includes a hollow cervical tube, a balloon and an applicator body, wherein the cervical catheter is in a preemployment state, with the balloon deflated and the applicator body at a proximal position, according to some embodiments;
  • Figure 2 schematically illustrations a section of part of the cervical catheter, in particular a distal part thereof which includes the balloon and an applicator body comprising a convexshaped head facing the os when the applicator body is in operable position, according to some embodiments;
  • Figure 3 is another schematic side-view illustration of the cervical catheter illustrated in Figure 1, rotated essentially by 90 degrees along its longitudinal axis relative to the view of Figure l;
  • Figure 4A schematically shows an expanded front view illustration of a lever for locking the position of the applicator body along the cervical tube, according to some embodiments
  • Figure 4B shows an expanded side view illustration the engagement of the lever with teeth
  • Figure 4C is a view of a cross-section of the applicator body from a point of view perpendicular to the view in Figure 2;
  • Figure 5A illustrates the cervical catheter after insertion of the balloon in a uterus and before inflation of the balloon
  • Figure 5B illustrates the cervical catheter after inflation of the balloon in the uterus and before relative movement of the applicator body and the balloon towards each other;
  • Figure 5C illustrates the cervical catheter after relative movement of the applicator body and the balloon towards each other
  • Figure 6 schematically illustrates a side-view illustration of a cervical catheter having a conical-shaped head
  • Figure 7A shows as a flow chart a method of inserting a cervical dilator
  • Figure 7B shows a flow chart a method of removing a cervical dilator.
  • aspects of embodiments relate to devices capable of mechanically dilating cervices.
  • the mechanically dilating devices are catheters.
  • the catheters are improved balloon catheters configured to allow improved mechanical dilation of a cervix.
  • the catheters are improved balloon catheters configured to allow improved application of force on both the internal os and the external os of the cervix, e.g., to induce labor or to abort a pregnancy.
  • inducing labor as well as grammatical variations thereof may also encompass the term “augmenting labor” or "speeding labor”.
  • a cervical catheter 100 may include a hollow cervical tube 110, a balloon 120 and an applicator body 140 having a convex-shaped surface or head 142 operable to engage the external os when the cervical catheter is in operable position.
  • balloon 120 extends from a distal end of cervical tube 110.
  • Hollow cervical tube 110 comprises a proximal catheter end 113 and a distal catheter end 112.
  • a balloon 120 may extend from a distal end 112 of cervical tube 110.
  • An applicator body 140 may be mounted on cervical tube 110. As schematically shown in FIG. 2 applicator body 140 may have a convex-shaped head 142. Optionally, applicator body 140 may comprise a stem such that the applicator body may be, for example, bulb-shaped. Convex shaped head 142 may face distal catheter end 112. Convex-shaped head 142 may be coupled with the stem 143. Optionally, convex-shaped head 142 may be mechanically fastened to stem 143. Optionally, convex-shaped head 142 and stem 143 may be integrally formed as one piece.
  • Catheter 100 may be configured to allow controllably inflating the balloon 120; maintaining the balloon 120 in an inflated state; and controllably deflating the balloon 120.
  • Catheter 100 may further be configured to allow movement of convex-shaped head 142 relative to distal catheter end 112. For example, convex-shaped head 142 may be moved towards distal catheter end 112 by pushing stem 143 towards the distal catheter end 112.
  • balloon 120 is shown in a deflated state.
  • balloon 120 is shown in a deflated state.
  • Cervical catheter 100 may comprise a lock mechanism for selectively locking (also: securing) and unlocking (also: unsecuring) the position of the applicator body 140 along the cervical tube 110.
  • the lock mechanism may be configured to frictionally and/or form-lockingly lock the position of the applicator body 140 along the cervical tube 110.
  • the catheter 100 (e.g., the lock mechanism thereof) may be configured to allow selectively locking and unlocking the applicator body 140, the locking essentially preventing the convex-shaped head 142 from retracting towards the proximal catheter end 113, for example, when a force is applied on the convex-shaped 142 in direction of the proximal catheter end 113.
  • the lock mechanism may comprise a ratchet and/or any other suitable lock mechanism, for example, as described herein.
  • the lock mechanism may comprise a lever 150 for selectively locking and unlocking the position of the applicator body 140 along the cervical tube 110.
  • Figure 4B shows in a side view and an expanded view the engagement of the lever 150 with teeth 116.
  • a lever-teeth engagement may be frictional and/or interlocking.
  • the catheter 100 may comprise a lock mechanism that is configured to lock and unlock the applicator body in a locked and unlocked state.
  • the applicator body or the optionally convex-shaped head thereof
  • the unlocked state the applicator body (or the optionally convex-shaped head thereof) can move towards the distal catheter end and, optionally, towards the proximal catheter end.
  • the cervical tube 110 may comprise a plurality of teeth 116 arranged essentially in a virtual line L in a direction of the longitudinal axis A of the cervical tube 110.
  • the lever 150 may be disposed on the virtual line L, and the locking may comprise engaging the lever 150 with a lever tooth 152 from the plurality of teeth 116, and the unlocking may comprise disengaging lever 150 from the plurality of teeth 116.
  • teeth 116 may be blunt. In some embodiments, teeth 116 may be crenated. In some embodiments both lever tooth 152 and plurality of teeth 116 may be crenated. [72] The series of blunt teeth 116 may extend along the cervical tube 110, essentially parallel to the longitudinal axis of the cervical tube 110.
  • lever 150 may be in-line with line of the teeth 116 such that lever tooth 152 is engageable with the teeth 116.
  • Lever 150 and teeth 116 may allow firm engagement of the applicator body 140 with the cervical tube 110, and limited travel of the applicator body 140 along the cervical tube 110, according to the state of the lever 150.
  • lever 150 may be operable by finger action.
  • the catheter may further comprise a rail 114 mounted on the cervical tube 110.
  • Rail 114 may be essentially parallel to a longitudinal axis A of the cervical tube 110.
  • applicator body 140 may have a slot 146 extending therethrough.
  • Slot 146 and rail 114 may be aligned and conform to each other to allow the moving of the convexshaped head 142 towards the distal catheter end 112 while restricting rotation of the applicator body 140 around the cervical tube 110 when the slot 146 is engaged with rail 114.
  • lever 150 Before insertion of the catheter 100, lever 150 may be engaged with the most proximal tooth 116, and balloon 120 is deflated.
  • a physician may insert catheter 100 with one hand into a pregnant woman's vagina (see arrow Cl in Figure 3) until balloon 120 passes the cervix into the uterus.
  • Figure 5a schematically shows catheter 100 fully inserted.
  • balloon 120 can be inflated, see arrows I in Figure 3, e.g., not to the final volume, e.g. 20 to 40 ml volume.
  • the catheter can then be gently pulled back, arrow C2, to engage balloon 120 with internal os, as further shown in Figure 5b.
  • the physician can with another hand manipulate the lever 150 and push the applicator body 140 along the cervical tube 110, arrow E in Figure 3, until the applicator body 140 rests against the external os.
  • a dilator force vector can be applied by the inflated balloon 120 on one side of the cervix and by applicator body 140 from the other side of the cervix, optionally obviating the need for traction.
  • traction on the balloon may be found to be helpful.
  • Catheter 100 may be placed to apply gentle traction, e.g., by fastening (e.g., taping) the proximal end of the cervical tube to the medial thigh.
  • repeatedly (e.g., periodically) pushing the applicator body 140 may serve to further dilate the cervix, as illustrated schematically in Figure 5C.
  • levers may be used and/or protuberances, such as a toothless lever and resilient bumps along the cervical tube that can engage the lever but give way when moderate force is used.
  • protuberances such as a toothless lever and resilient bumps along the cervical tube that can engage the lever but give way when moderate force is used.
  • Another embodiment may have the lever on the interior of the cervical catheter.
  • the lever may be connected to the applicator body via a slit along the cervical catheter. This lever may normally engage an interior wall of the cervical catheter, and the applicator body may be arranged such that finger pressure at an appropriate location on or in the applicator body (outside the cervical catheter) employs force on the lever to disengage the lever from the interior wall.
  • catheter 100 may comprise a stopper 115 delimiting the moving of the convex-shaped head 142 towards the distal catheter end 112.
  • stopper 115 may be positioned on the cervical tube 110, distal and in line with the teeth 116. Stopper 115 may be more prominent and/or more resilient than the teeth 116, such as to prevent any further movement of the applicator body 140 in the direction of distal end 112.
  • Teeth 116 and stopper 115 may be, for example, no wider than the width of the lever 150 (all widths measurable in a direction orthogonal to the longitudinal axis A of the cervical tube 110 and the radius of the same).
  • the catheter 100 further comprises: a hollow first inner tube 130a, extending from outside the proximal end 113, within the cervical tube 110 to the balloon 120.
  • the balloon 120 may be inflatable with fluid by passing the fluid from outside proximal end 113, through first inner tube 130a and into balloon 120.
  • Balloon 120 can be inflated by injecting a liquid such as saline solution via first inner tube 130a.
  • catheter 100 may comprise a hollow second inner tube 130b, extending from outside proximal end 113, within cervical tube 110 to outside distal end 112, wherein catheter 100 is configured to allow receiving fluids from outside distal end 112, via second inner tube 130b to outside proximal end 113, e.g., for collecting samples of fluid from the uterus via second inner tube 130b.
  • the catheter 100 further comprises a soft nipple 122, sealing distal end 112.
  • hollow second inner tube 130b extends from outside the proximal end 113, throughout the cervical tube 110 and nipple 122, wherein the catheter 100 is configured to allow receiving fluids from outside distal end 112, via the second inner tube 130b to outside the proximal end 113.
  • Outside diameter of the applicator body 140 at its widest part may for example range from 3 cm to 6 cm, or from 4 cm to 5 cm.
  • the shape and size of the convex-shaped head may essentially conform to the shape of the vagina proximal to the external os, so that the applicator body 140 creates at least some pressure from within the cervix with minimum discomfiture.
  • the convex-shaped head may essentially have the shape of a spherical cap.
  • the head may essentially have the shape of a dome.
  • the shape may be essentially frustoconical.
  • the head may have further alternative surface geometries.
  • the balloon, inflation tube and catheter shaft may be constructed of a variety of materials including, for example, biocompatible materials. These materials include, but are not limited to, silicone, rubber including nitrile rubber, styrene butadiene rubber, Viton, or butyl rubber, silicone elastomer, Dacron-reinforced silicon material, latex, polyethylene, Mylar, or Teflon.
  • the material for the balloon can be elastomeric in nature to allow for expansion and contraction of the balloon as it is inflated or deflated.
  • biocompatible may refer to a material that is substantially non-toxic in the in vivo environment of its intended use, and that is not substantially rejected by the patient's physiological system (i.e., is non-antigenic). This can be gauged by the ability of a material to pass, for example, the biocompatibility tests set forth in International Standards Organization (ISO) Standard No. 10993 and/or the U.S. Pharmacopeia (USP) 23 and/or the U.S. Food and Drug Administration (FDA) blue book memorandum No.
  • ISO International Standards Organization
  • USP U.S. Pharmacopeia
  • FDA U.S. Food and Drug Administration
  • G95-1 entitled "Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part-1: Evaluation and Testing.” Typically, these tests measure a material's toxicity, infectivity, pyrogenicity, irritation potential, reactivity, hemolytic activity, carcinogenicity and/or immunogenicity.
  • a biocompatible structure or material when introduced into a majority of patients, will not cause a significantly adverse, long-lived or escalating biological reaction or response, and is distinguished from a mild, transient inflammation which typically accompanies surgery or implantation of foreign objects into a living organism.
  • the distal part may be as smooth and as continuous as possible, to reduce to the minimum possible within manufacture constraints any cracks or blimps that might cause discomfiture.
  • the applicator body 140 can be made by 3D printing or extrusion for example.
  • the applicator body 140 may for example be made of a transparent material that is not deformable by action of finger against the stem or distal convex-shaped head 142, or pressure against the external os.
  • a transparent material that is not deformable by action of finger against the stem or distal convex-shaped head 142, or pressure against the external os.
  • polypropylene, polyethylene, and/or polycarbonate or combinations thereof are transparent.
  • Such transparent applicator body 140 and, optionally, transparent expandable body 120 such as a balloon may allow a medical professional (e.g., a physician) to visually examine the extent of dilatation of the cervix while applying a force on both the internal os and the external os through operable employment of the cervical catheter 100.
  • the visual examination can be performed with the naked or unaided eye, i.e., without requiring magnifying or light-collecting optical instruments. It is noted that the employment of corrective lenses to correct vision to normal acuity is still be considered to be "naked".
  • the applicator body 140 may apply a sealing pressure against the inner os, thus reducing or preventing flow of fluid from the uterus via the cervix into the vaginal lumen, ensuring comparatively unobstructed vision of the external os through the vaginal lumen during dilatation of the cervix with the cervical catheter 100.
  • the sealing of the external os facilitates monitoring of the cervix' dilatation, for example, with the naked eye and/or with one or image sensors (also: imagers).
  • cervical catheter 100 may comprise one or more image sensors (not shown) which may for example be arranged on applicator body 140 to allow imaging of the external and/or internal os or the cervix during dilatation thereof with the assistance of the cervical catheter 100.
  • cervical catheter 100 may comprise one or more sensor 162 (e.g., 162A and 162B) that are operable to measure the force and/or pressure applied onto the inner os, the external os and/or the cervix (e.g., onto the tissue defining the cavity of the cervix).
  • cervical catheter 100 may comprise sensors 162 (e.g., 162C-D) that are operable to measure a traction force applied along the longitudinal axis of the cervical tube.
  • the sensors may be part of a control module 160.
  • sensors 162 may be coupled with and/or comprise circuitry of the control module.
  • Control module 160 may be operable to analyze sensed physical parameter values and/or operable to provide an output relating to the measured physical parameters.
  • control module 160 is operable to provide an output indicative of the measured physical parameters.
  • control module 160 is operable to provide an alert if an exerted force and/or pressure exceeds a force/pressure threshold value.
  • Control module 160 may be implemented, for example, by a processor and/or a memory. The memory can store instructions that are executable by the processor.
  • control module 160 is operable to provide the user, based on the sensed physical parameters, with instructions concerning the operation of the cervical catheter (e.g., moving applicator body in direction of or away from expandable body, and/or the like) to reduce or increase pressure onto the external os, the internal os, and/or the tissue defining the cervix cavity.
  • instructions concerning the operation of the cervical catheter e.g., moving applicator body in direction of or away from expandable body, and/or the like
  • the applicator body 140 may further comprise ribs 144 extending along stem 143. Ribs 144 may extend in a direction of the longitudinal axis of cervical tube 110. Lever 150 may be disposed in between adjacent ribs of the plurality of ribs 144. The adjacent ribs may be distanced to serve as a guide for the physician's finger to engage lever 150.
  • the present device allows the freedom to move applicator body 140 relative to balloon 120.
  • the space between the two balloons in the double-balloon catheter may be too large, whereby pressure may not be applied against both cervical openings, at the beginning of the application of the catheter or later, when the cervix shortens as it widens.
  • Applicator body 140 may be further pushed in as required to maintain pressure and further widen the cervix.
  • Thickness of cervical tube 110 can be designed and manufactured to provide a most suitable flexibility/rigidity for comfortable and efficient manipulation.
  • the cervical tube can be made of a softer, optionally transparent, material, and cervical tube 110 may be led by a removable wire (not shown) inside cervical tube 110, or a relatively rigid wrapper (not shown) on cervical tube 110 that is grasped to lead the cervical tube 110, being peeled along the way.
  • first inner tube 130a and second inner tube 130b may have an adaptor at their ends extending out from the proximal end 113 of the cervical tube 110.
  • first inner tube 130a and second inner tube 130b may comprise or have operationally connected thereto a check-valve (not shown) that allows inflating the balloon 120 and a release valve (not shown) for deflating the balloon 120.
  • Second inner tube 130b may comprise or have operationally connected thereto a check valve that allows passage of fluid from the nipple 122 to proximal end 113 of cervical tube 110.
  • Catheter 100 may thus allow monitoring by collecting fluids from the uterus, and preventing hazardous confusion between the inner tubes 130a, 130b.
  • the cervical tube 110 may be designed to be insertable through a cervix.
  • the cervical tube may have an outside diameter of, for example, l-3cm or of, for example, 1.5 to 2.5 cm.
  • the balloon has a capacity of inflation to at least 60ml.
  • a kit may be provided including a handle releasingly connectable to catheter 100 to facilitate insertion and other manipulations.
  • the cervical tube contains more inner tubes for additional purposes, such as flushing the cervix and/or the uterus, insertion and removal of a wire etc.
  • the inner tubes may be marked to help guide the physician as to the role of each inner tube.
  • kits embodiments comprise catheter 100 and a birth inducer composition such as otocin. As a rule, the catheter is kept in place for no longer than 12 hours, and if the birthing is not completed by then the birth inducer composition may be administered as is known in the art.
  • the fetal membranes may well rupture while catheter 100 is inserted.
  • Second inner tube 130b serves to provide samples that can indicate the rupture.
  • the catheter 100 can be immediately removed by deflating balloon 120 and subsequently gently pulling cervical tube 110.
  • Catheter 100 may comprise, or a kit embodiment including catheter 100 may comprise, fasteners (not shown) for fixating position thereof relative to the uterus, e.g., by attaching catheter 100 to the patient, for example to a thigh of the patient.
  • catheter 100 may in some embodiments be coated with prostaglandins and/or other labor-inducing drug.
  • catheter 100 may comprise a mechanism (not shown) allowing, e.g., the controlled intravaginal delivery of labor- inducing drugs.
  • inducing labor and “inducting birth”, as well as grammatical variations thereof, may herein be used interchangeably.
  • a method of operating a cervical dilator may include:
  • A) Providing a hollow cervical tube 110 which may comprise a proximal catheter end 113 and a distal catheter end 112; a balloon 120 which may extend from a distal end 112 of the cervical tube 110, wherein an applicator body 140 may be mounted on cervical tube 110.
  • Applicator body 140 comprises a stem 143, and a convex-shaped head.
  • Convex-shaped head 142 may face distal catheter end 112.
  • Convex-shaped head 142 may be coupled with stem 143.
  • B) Maintaining balloon 120 in a controllably deflated state, and concomitantly pushing proximal end 113 such that balloon 120 travels through a cervix and into a uterus.
  • the method may include providing a cervical dilator that comprises a hollow cervical tube which includes a proximal catheter end and a distal catheter end; a balloon, and an applicator body which is mounted on the cervical tube.
  • the applicator body which may be bulb-shaped, may comprise a stem and a convex-shaped head coupled to the stem.
  • the convex-shaped head may face the distal catheter end, and the stem may face the proximal catheter end.
  • the method may further include maintaining the balloon in a controllably deflated state, and concomitantly pushing the proximal end.
  • the method may include checking if the balloon is in the uterus. If not, the method may include repeating step 220. If yes, the method may include proceeding to step 240 which may include maintaining the balloon in an inflated state and, concomitantly, pulling the proximal end catheter end until the balloon abuts an internal orifice.
  • the method may further include pushing the stem towards the distal catheter end.
  • the insertion method may comprise pushing the stem until the convex-shaped head of the applicator body abuts the external orifice.
  • the insertion method may comprise intermittently pushing the stem thereby maintaining abutment of the applicator body with the external orifice.
  • Fig. 7B illustrating a flow chart of method 300 for removing the dilator.
  • the method may include deflating the balloon.
  • the method may then include pulling the dilator out of the vagina.
  • Example 1 includes cervical dilator catheter comprising a cervical tube having a proximal cervical tube end and a distal cervical tube end; an expandable body that is in fluid communication with the cervical tube; an applicator body mounted on the cervical tube; a stem; a convex-shaped head connected to the stem, the convex-shaped head facing the distal cervical tube end; wherein the catheter is configured to controllably each of: expanding the expandable body; maintaining the expandable body in an expanded state; contracting the expandable body, and moving the convex-shaped head towards the distal catheter end by pushing the stem towards the distal cervical tube end.
  • Example 2 includes the subject matter of Example 1 and, optionally, wherein the catheter is further configured to allow locking and unlocking the convex-shaped head, the locking essentially preventing the convex-shaped head from moving towards the distal catheter end ⁇
  • Example 3 includes the subject matter of Example 2 and, optionally, wherein the catheter further comprises a manually operable lever; the cervical tube comprises a plurality of teeth arranged essentially in a line in a direction of the longitudinal axis of the cervical tube; the lever is disposed on the line, and wherein the locking comprises engaging the lever with a tooth from the plurality of teeth, and the unlocking comprises disengaging the lever from the tooth from the plurality of teeth.
  • Example 4 includes the subject matter of example 3 and, optionally, wherein the teeth are blunt.
  • Example 5 includes the subject matter of examples 3 or 4 and, optionally, wherein the teeth are crenated.
  • Example 6 includes the subject matter of any of the examples 3 to 5, wherein the lever is operable by finger action; the cervical tube further comprises a rail mounted on the cervical tube, the rail essentially parallel to a longitudinal axis of the cervical tube; the applicator body has a slot extending therethrough, and the slot and rail are aligned and conform to each other to allow: the moving of the convex-shaped head towards the distal cervical tube end, and restricting rotation of the applicator body around the cervical tube when the slot is engaged with the rail.
  • Example 7 includes the subject matter of any of the examples 1 to 6 and, optionally, wherein the cervical tube further comprises a stopper delimiting the moving of the convex shaped head moving towards the distal cervical tube end ⁇
  • Example 8 includes the subject matter of any one of the examples 1 to 7 and, optionally, a hollow first inner tube, extending from outside the proximal end, within the cervical tube to the expandable body, wherein the expandable body is expandable with fluid by passing the fluid from outside the proximal end, through the first inner tube and into the expandable body.
  • Example 9 includes the subject matter of any one of the examples 1 to 8 and, optionally, a hollow second inner tube, extending from outside the proximal end, within the cervical tube to outside the distal end, and wherein the cervical tube is configured to allow receiving fluids from outside the distal end, via the second inner tube to outside the proximal end.
  • Example 10 includes the subject matter of any one of the Examples 1 to 9 and, optionally, a soft nipple, sealing the distal end.
  • Example 11 includes the subject matter of any one of the Examples 1 to 10 and, optionally, a hollow second inner tube, extending from outside the proximal end, throughout the cervical tube and the nipple, wherein the cervical tube is configured to allow receiving fluids from outside the distal end, via the second inner tube to outside the proximal end.
  • Example 12 includes the subject matter of any of the Examples 1 to 11 and, optionally, wherein the applicator body has a diameter ranging from about 3 to 6cm at widest part thereof.
  • Example 13 includes the subject matter of any of the Examples 1 to 12 and, optionally, wherein the applicator body has a diameter ranging from about 4 cm to about 5 cm at widest part thereof.
  • Example 14 includes the subject matter of any of the Examples 1 to 13 and, optionally, wherein the applicator body and, optionally, the cervical tube and/or the expandable body are essentially transparent.
  • Example 15 includes the subject matter of any of the Examples 1 to 14 and, optionally, wherein the applicator body comprises one or more material selected from a group consisting of: polypropylene, polyethylene, and polycarbonate.
  • Example 16 includes the subject matter of any of the Examples 3 to 15 and, optionally, wherein the stem comprises a plurality of ribs; wherein the lever is disposed in between adjacent ribs of the plurality of ribs, and where the adjacent ribs are spaced at least 2.5 cm apart.
  • Example 17 includes the subject matter of Example 16 and, optionally, wherein the adjacent ribs are spaced 3-4 cm apart.
  • Example 18 includes the subject matter of any one of the Examples 1 to 17 and, optionally, wherein the convex-shaped head is one of dome-shaped, conical-shaped, frustro-conical-shaped or spherical-shaped.
  • Any digital computer system, module and/or engine exemplified herein can be configured or otherwise programmed to implement a method disclosed herein, and to the extent that the system, module and/or engine is configured to implement such a method, it is within the scope and spirit of the disclosure.
  • the system, module and/or engine are programmed to perform particular functions pursuant to computer readable and executable instructions from program software that implements a method disclosed herein, it in effect becomes a special purpose computer particular to embodiments of the method disclosed herein.
  • the methods and/or processes disclosed herein may be implemented as a computer program product that may be tangibly embodied in an information carrier including, for example, in a non-transitory tangible computer-readable and/or non-transitory tangible machine-readable storage device.
  • the computer program product may directly loadable into an internal memory of a digital computer, comprising software code portions for performing the methods and/or processes as disclosed herein.
  • a computer readable signal medium may include a propagated data signal with computer readable program code embodied therein, for example, in baseband or as part of a carrier wave. Such a propagated signal may take any of a variety of forms, including, but not limited to, electro-magnetic, optical, or any suitable combination thereof.
  • a computer readable signal medium may be any computer readable medium that is not a non-transitory computer or machine-readable storage device and that can communicate, propagate, or transport a program for use by or in connection with apparatuses, systems, platforms, methods, operations and/or processes discussed herein.
  • non-transitory computer-readable storage device and “non-transitory machine-readable storage device” encompasses distribution media, intermediate storage media, execution memory of a computer, and any other medium or device capable of storing for later reading by a computer program implementing embodiments of a method disclosed herein.
  • a computer program product can be deployed to be executed on one computer or on multiple computers at one site or distributed across multiple sites and interconnected by one or more communication networks.
  • These computer readable and executable instructions may be provided to a processor of a general purpose computer, special purpose computer, or other programmable data processing apparatus to produce a machine, such that the instructions, which execute via the processor of the computer or other programmable data processing apparatus, create means for implementing the functions/acts specified in the flowchart and/or block diagram block or blocks.
  • These computer readable and executable program instructions may also be stored in a computer readable storage medium that can direct a computer, a programmable data processing apparatus, and/or other devices to function in a particular manner, such that the computer readable storage medium having instructions stored therein comprises an article of manufacture including instructions which implement aspects of the function/act specified in the flowchart and/or block diagram block or blocks.
  • the computer readable and executable instructions may also be loaded onto a computer, other programmable data processing apparatus, or other device to cause a series of operational steps to be performed on the computer, other programmable apparatus or other device to produce a computer implemented process, such that the instructions which execute on the computer, other programmable apparatus, or other device implement the functions/acts specified in the flowchart and/or block diagram block or blocks.
  • engine and module may comprise one or more computer modules, wherein a module may be a self-contained hardware and/or software component that interfaces with a larger system.
  • a module may comprise a machine or machines executable instructions.
  • a module may be embodied by a circuit or a controller programmed to cause the system to implement the method, process and/or operation as disclosed herein.
  • a module may be implemented as a hardware circuit comprising, e.g., custom VLSI circuits or gate arrays, an Application-specific integrated circuit (ASIC), off-the-shelf semiconductors such as logic chips, transistors, and/or other discrete components.
  • a module may also be implemented in programmable hardware devices such as field programmable gate arrays, programmable array logic, programmable logic devices and/or the like.
  • Coupled with can mean indirectly or directly “coupled with”.
  • the method may include is not limited to those diagrams or to the corresponding descriptions.
  • the method may include additional or even fewer processes or operations in comparison to what is described in the figures.
  • embodiments of the method are not necessarily limited to the chronological order as illustrated and described herein.
  • each of the verbs, "comprise” “include” and “have”, and conjugates thereof, are used to indicate that the object or objects of the verb are not necessarily a complete listing of components, elements or parts of the subject or subjects of the verb.
  • the phrase "A,B,C, or any combination of the aforesaid” should be interpreted as meaning all of the following: (i) A or B or C or any combination of A, B, and C, (ii) at least one of A, B, and C; (iii) A, and/or B and/or C, and (iv) A, B and/or C.
  • the phrase A, B and/or C can be interpreted as meaning A, B or C.
  • the phrase A, B or C should be interpreted as meaning "selected from the group consisting of A, B and C". This concept is illustrated for three elements (i.e., A,B,C), but extends to fewer and greater numbers of elements (e.g., A, B, C, D, etc.).
  • operable to can encompass the meaning of the term “adapted or configured to”.
  • a machine “operable to” perform a task can in some embodiments, embrace a mere capability (e.g., "adapted”) to perform the function and, in some other embodiments, a machine that is actually made (e.g., "configured”) to perform the function.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Anesthesiology (AREA)
  • Gynecology & Obstetrics (AREA)
  • Pregnancy & Childbirth (AREA)
  • Reproductive Health (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Hematology (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Surgical Instruments (AREA)

Abstract

Certains aspects de modes de réalisation concernent un tube cervical de dilatateur cervical qui peut comprendre un tube cervical creux comprenant une extrémité proximale de tube cervical et une extrémité distale de tube cervical ; un corps expansible ; et un corps d'applicateur monté sur le tube cervical. Le tube cervical peut en outre comprendre une tige et une tête de forme convexe accouplée à la tige. La tête de forme convexe fait face à l'extrémité distale du tube cervical creux. Le tube cervical peut être conçu pour permettre de réaliser de manière commandée chacune des étapes suivantes : expansion du corps expansible ; maintien du corps expansible dans un état déployé ; contraction du corps expansible et déplacement de la tête de forme convexe vers l'extrémité distale du tube cervical creux, par exemple, par la poussée de la tige vers l'extrémité distale du tube cervical creux.
PCT/IB2019/052472 2018-03-29 2019-03-27 Dilatateur cervical WO2019186414A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US201862649792P 2018-03-29 2018-03-29
US62/649,792 2018-03-29
US201862688584P 2018-06-22 2018-06-22
US62/688,584 2018-06-22

Publications (1)

Publication Number Publication Date
WO2019186414A1 true WO2019186414A1 (fr) 2019-10-03

Family

ID=68059346

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2019/052472 WO2019186414A1 (fr) 2018-03-29 2019-03-27 Dilatateur cervical

Country Status (1)

Country Link
WO (1) WO2019186414A1 (fr)

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20080109010A1 (en) * 2006-11-07 2008-05-08 Femsuite, Llc Apparatus for cervical manipulation and methods of use
US20080319472A1 (en) * 2007-06-19 2008-12-25 Marion Stevens Shelley Cervical dilator catheter
CN204932561U (zh) * 2015-07-22 2016-01-06 江苏中林医疗科技发展有限公司 宫颈扩张器

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20080109010A1 (en) * 2006-11-07 2008-05-08 Femsuite, Llc Apparatus for cervical manipulation and methods of use
US20080319472A1 (en) * 2007-06-19 2008-12-25 Marion Stevens Shelley Cervical dilator catheter
CN204932561U (zh) * 2015-07-22 2016-01-06 江苏中林医疗科技发展有限公司 宫颈扩张器

Similar Documents

Publication Publication Date Title
US5248304A (en) Single use intrauterine injector
US3848602A (en) Abortion facilitating device and process
US6758831B2 (en) Device and method for aligning with the tubal ostium
US6080129A (en) Method and apparatus for performing hysterosalpingography
JP2972520B2 (ja) 女性の子宮およびファロピオ管にアクセスする方法および装置
US20100145224A1 (en) Canal dilation device
US20050277948A1 (en) Apparatus and methods for the administration of a cerclage
US20070288051A1 (en) Fluid-filled cervical dilator
US20080319472A1 (en) Cervical dilator catheter
US20080077054A1 (en) Cervical dilator and methods of use
US20060235461A1 (en) Single balloon ripening device with novel inserter and inflator
WO2005118048A2 (fr) Systeme de dilatation de canal corporel
US20100082057A1 (en) Variable rigidity vaginal dilator and use thereof
US10238424B2 (en) Obstetric apparatus and method
US20130245664A1 (en) Cervical dilator
JP2016536101A (ja) 子宮頸部安定化デバイス
EP3038692A1 (fr) Dilatateur cervical
US11207101B2 (en) System and methods for facilitating child birth
CN210612678U (zh) 一种带可移动式护套的子宫球囊支架
WO2019186414A1 (fr) Dilatateur cervical
WO2001068181A1 (fr) Dispositif gonflable servant a dilater le col de l'uterus
US4270541A (en) Instrument for induction of labor
AU2019100697A4 (en) A Device and Method for Inducing Cervical Dilation
RU2363503C2 (ru) Устройство для проведения гистеросальпингографии
AU2021211118A1 (en) An intrauterine system with a locking part

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 19775985

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 19775985

Country of ref document: EP

Kind code of ref document: A1