Abstract:
Traditional and existing methods of cervical ripening employ a Foley Bulb designed for and typically used in bladder procedures. Consequently, the application to the cervix is sub-optimal. The described device resolves this and related limitations. The device includes a balloon that has been designed to accommodate the cervix geometry, and which can adapt to normal differences in the individual. Further improvements are attained by the use of a supporting device which couples the cervix ripening device to the individual.

Description:
BACKGROUND OF THE INVENTION 
       [0001]    1. Field of the Invention 
         [0002]    The invention generally relates to cervical ripening devices and methods. 
         [0003]    2. Description of the Relevant Art 
         [0004]    Cervical ripening refers to the effacement or thinning of the cervix followed by dilation in preparation for the birthing process. Critical factors in the initiation of the ripening process include release of enzymes, hormonal factors, and local pressure on the internal os of the cervix as a result of the fetus&#39; head following decent. When the progression of cervical ripening is slow or is not naturally initiated, stimulation by insertion and inflation of a balloon catheter to apply additional local has been shown to be effective. 
         [0005]    Current methodology utilizes a Foley urinary catheter that is inserted into the cervical os and inflated to 50 to 80 ml with saline solution. The resulting spherical balloon is 5 to 6 cm in diameter. The area in contact with the internal os is roughly 30 to 45 cm 2  with the locally applied pressure a function of the cosine of the angle between the axis of the cervical channel and the point of contact by the balloon. The addition of approximately 1 Kg to the distal end of the Foley catheter has improved the ripening process substantially. 
         [0006]    Several problems with the Foley catheter approach to cervical ripening are evident. Since the balloon is spherical, local pressure is not uniform over the internal os. This presents the potentiality that local release of hormonal and enzymatic factors are not uniformly induced in the cervix, thus, sub-optimally facilitating cervical ripening. Only the lower hemisphere of the balloon that is prescribed by the bisection of the catheter balloon by a plane perpendicular to the catheter axis is in contact with the internal os. The upper hemisphere protrudes in to the uterus potentially applying elevated pressure to the head of the fetus. The tip of the Foley catheter presents addition protrusion in to the uterus potentially injuring the fetus. The added kilogram of weight is generally a liter bag of saline solution which is allowed to hang over the side of the bed. Significant discomforts to the patient and the potential of injury from inadvertent snagging of the bag are added complications with this method. 
       SUMMARY OF THE INVENTION 
       [0007]    A cervical ripening device includes an elongated tube comprising a first end and a second end; a balloon coupled to the second end of the elongated tube; wherein the balloon has a shape and size that matches the shape of the internal os of the cervix of a subject having a fetus present in the subject&#39;s uterus; and a support device coupled to the elongated tube, wherein the support device is couplable to a portion of the subject. In one embodiment, the elongated tube comprises an outer tube and an inner tube, wherein fluid used to fill the balloon is passed through the inner tube into the balloon during use. 
         [0008]    In one embodiment, the balloon is substantially disk shaped. The portion of the balloon in contact with the cervix may have a curvature that substantially matches the curvature of the internal os of the cervix when a fetus is present in the uterus. In one embodiment, the balloon comprises a first disk and a second disk coupled to the first disk at the outer edge, wherein the first disk includes a reinforced material and the second disk comprises a membrane that is inflatable during use. 
         [0009]    The support device, in one embodiment, may include a band couplable to the subject&#39;s leg. The elongated tube may be variably positionable with respect to the support device to alter the pressure placed on the internal os of the subject&#39;s cervix. In one embodiment, the support device is in the form of a pubic saddle that includes a first support member and a second support member coupled to each other. The first support member and the second support member couple to the pubic bone region of the subject and provide an outward force against the balloon during use. In an embodiment, the outward force applied on the balloon is altered by adjusting the position of the elongated tube with respect to the support device. The outward force applied to the balloon may be altered by adjusting a threaded collar engaged to threading on the elongated tube to adjust the position of the elongated tube with respect to the cervix. 
         [0010]    In an embodiment, a method of inducing dilation of the cervix of a subject includes placing at least a portion of a cervical ripening device into the cervix of the subject, coupling the support device to the subject; inflating the balloon, wherein the balloon is positioned against the internal os of the cervix when inflated; and applying pressure to the cervix by moving the elongated tube away from the cervix. 
         [0011]    In an embodiment, the cervical ripening device may be positioned by placing an insertion device into the cervix of the subject, and inserting at least a portion of the cervical ripening device through the insertion device into the cervix of the subject. 
         [0012]    In an embodiment, applying pressure to the cervix includes adjusting a threaded collar engaged to threading on the elongated tube to adjust the position of the elongated tube with respect to the cervix. 
         [0013]    A kit for of inducing dilation of the cervix of a subject may includes a cervical ripening device, an inserter for use in placing the cervical ripening device into the cervix of the subject; and one or more syringes for injecting a fluid into the balloon during use. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0014]    Advantages of the present invention will become apparent to those skilled in the art with the benefit of the following detailed description of embodiments and upon reference to the accompanying drawings in which: 
           [0015]      FIG. 1  depicts a projection view of an embodiment of an elongated tube of a cervical ripening device; 
           [0016]      FIG. 2  depicts a projection view of an embodiment of a cervical ripening device having a support device; 
           [0017]      FIG. 3  depicts a projection view of an alternate embodiment of a cervical ripening device having a support device; 
           [0018]      FIG. 4  depicts a projection view of an insertion device; and 
           [0019]      FIG. 5  depicts a cervical ripening kit. 
       
    
    
       [0020]    While the invention may be susceptible to various modifications and alternative forms, specific embodiments thereof are shown by way of example in the drawings and will herein be described in detail. The drawings may not be to scale. It should be understood, however, that the drawings and detailed description thereto are not intended to limit the invention to the particular form disclosed, but to the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the present invention as defined by the appended claims. 
       DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
       [0021]    It is to be understood the present invention is not limited to particular devices or methods, which may, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting. As used in this specification and the appended claims, the singular forms “a”, “an”, and “the” include singular and plural referents unless the content clearly dictates otherwise. Furthermore, the word “may” is used throughout this application in a permissive sense (i.e., having the potential to, being able to), not in a mandatory sense (i.e., must). The term “include,” and derivations thereof, mean “including, but not limited to.” The term “coupled” means directly or indirectly connected. 
         [0022]    To remedy at least some of the problems associated with using a traditional Foley catheter to induce cervical dilation, the following parameters were identified. A cervical ripening device should:
       1. have an inflatable balloon having a conformation similar to that of the cervix internal os;   2. apply a uniform distribution of force over the contact area of the cervix internal os;   3. incorporate an internal channel for infusion of sterile saline;   4. be capable of deployment of the catheter through an insertion device; and   5. utilize the elasticity of the catheter in combination with a support device to apply and fix traction onto the cervix internal os in a measurable and consistent fashion.       
 
         [0028]    The curvature of the cervix internal os surface, however, is not uniform but varies to approximate the curvature of the fetal head. In the frontal or coronal plane the radius of curvature is approximately 4.5 cm, with the lateral or sagittal plane curvature average of 5.6 cm (5.0 cm radius posterior to the ear and 5.8 anterior to the ear). The average radius of curvature of the cervix internal os is roughly 5 cm. 
         [0029]    In the current usage of the Foley catheter for initiation of cervical ripening, a balloon is inflated with 60 to 80 ml of sterile saline. The infused volume produces a spherical balloon having a diameter between 5 and 6 cm. As noted above, however, the balloon is spherical and local pressure is not uniform over the cervix internal os due to the differences in curvature. 
         [0030]    To remedy the non-uniform shape of the cervix internal os, a balloon was designed to better match the known curvature of the internal os when a fetus is present. In one embodiment, a balloon is formed from two silicone disks as shown in  FIG. 1 . A cervical ripening device  100  includes an elongated tube  110  and a balloon  120  that is formed from two silicone disks  122  and  124 . The balloon  120  includes, in one embodiment, two 5.5 cm diameter concave silicone disks  122  and  124  having a radius of curvature of 5 cm. The disks may generally have a diameter ranging from about 1 cm to about 10 cm and a radius of curvature of between about 1 cm to about 10 cm. 
         [0031]    Upper disk  122  may be fiber reinforced silicone. The fiber may limit expansion of the upper disk, helping to define the shape and size of the balloon. Lower disk  124  is composed of a silicone membrane that may be expand when a fluid is introduced into the balloon. During use lower disk  124  contacts the cervix internal os of the patient. The fluid in the balloon helps the lower disk to conform with the shape of the subjects cervix. The disks may be bonded at the outer edge to form an inflatable cavity having a volume of approximately 2-4 ml. Openings  125  on the central axis of the disks couple the balloon to the elongated tube  110 . The disks are bonded to elongated tube  110  such that the upper disk  122  is coplanar with the tip of the elongated tube and the lower (membrane) disk  124  is bonded 1 to 2 mm below the upper disk. 
         [0032]    The area of the cervix internal os in contact with the inflated disk balloon  120  varies from about 15 cm 2  to about 40 cm 2  depending on the size and radius of curvature of the disks. In an embodiment, when the disks have a diameter of 5.5 cm and a radius of curvature of 5 cm, the area of internal os contact is about 23.5 cm 2 . An advantage of the above described balloon, is that the balloon can adapt and/or form to match both the specific shape of the internal os and/or the infant&#39;s head. 
         [0033]    Elongated tube  110  may be formed from a flexible material that has a stiffness suitable for easy insertion, a low resistance internal channel for saline injection, and sufficient wall thickness for incorporation of a balloon inflation channel. In one embodiment, a 0.25 in outside diameter silicone tube with 0.063 in wall thickness was selected as the elongated tube  110  for the cervical ripening device. Elongated tube  110  may have a length of about 20 cm to about 50 cm long. The tube should have a length sufficient to allow the tube to extend from the subjects cervix to a position proximate to the legs of the patient. 
         [0034]    In one embodiment, elongated tube  110  is composed of an outer tube  112  and an inner tube  114 . Inner tube  114  is used for inflation of balloon  120 . Inner tube  114  is used to inject a fluid into the balloon, is of low resistance and allows easy infusion of aqueous fluids. In one embodiment, saline is injected into the balloon to inflate the balloon during use. Outer tube may be used for injection of an amniotic saline infusion. 
         [0035]    A support device may be coupled to the elongated tube. The support device is couplable to a portion of the subject to secure the catheter to the subject. The support device also is configured to allow the forces applied to the balloon to be varied by adjusting the position of the elongated tube with respect to the support device. 
         [0036]    An embodiment of a cervical ripening device having a support device is depicted in  FIG. 2 . Cervical ripening device  200  includes an elongated tube  210  and a balloon  220  coupled to the elongated tube  210 . A support device  230  is coupled to elongated tube  210 . Support device  230  is, in one embodiment, includes a band  234  couplable to the subject&#39;s leg. A coupling  232  couples band  234  to elongated tube  210 . 
         [0037]    Support device  230  inhibits dislodgment of the cervical ripening device from the subject. Support device also provides a stable anchor from which tension can be applied to the balloon. In the embodiment depicted in  FIG. 2 , a threaded collar  250  is coupled to external threading (not shown, depicted in  FIG. 1  as elements  150  and  152 ) of elongated member  210 . Turning threaded collar  250  in a predetermined direction causes elongated tube  210  to move in a direction away from coupling  232 . Movement of elongated tube  210  away from the coupling  232  creates tension on balloon  210  during use. In one example, it was determined that the application of 9.8N (1 Kg×9.8 m/sec 2 ) of tension to the cervical ripening device tube results in a calculated uniform pressure distribution of around 0.41 N/cm 2  to the cervix internal os. In one embodiment, calibration marks may be formed on the elongated tube to allow the user to estimate the pressure applied to the cervix by the device. 
         [0038]    In an alternate embodiment, a support device  320  may include a pubic saddle that is used as a support device  330 , as depicted in  FIG. 3 . Pubic saddle includes a first support member  332  and a second support member  334  coupled to each other through coupling support  336 . First support member  332  and second support member  334  have a shape which is complementary with the general shape and size of the pubic bone region. During use, first support member  332  and second support member  334  are coupled to the pubic bone region of the subject and balloon  320  is inserted into the cervix. Elongated tube  310  is fixedly coupled to coupling support  336 . During use, pressure may be increased on the cervix by moving the elongated tube away from the coupling support. Coupling support may engage elongated tube using a threaded collar  350  coupled to threads on the elongated tube. Calibrations on the collar specify may be used to estimate the tension on the cervix. The pubic saddle design for the support device allows easy access to the vaginal canal. 
         [0039]      FIG. 4  depicts an insertion device  400  used to properly position the cervical ripening device in the proper position. In one embodiment, insert is formed from a polymeric tube with end designs that will provide easy insertion while minimizing potential injury. In one embodiment, insertion device  400  is composed of a polypropylene material, similar to the material that is used to facilitate tampon insertion. Insertion device  400  may include an insertion tube  410  and receiving tube  420 . During use, insertion device  400  is placed in the cervix of the subject such that end  412  of insertion tube  410  enters the uterus of the subject. A cervical dilator device, such as the devices described herein, may be positioned in the receiving tube  420  of the inserter and passed through insertion tube  410 , such that the balloon of the cervical dilator device is positioned in the uterus. The use of an inserter allows easy insertion and positioning of the cervical dilator device. In some embodiments, marking on the insertion device may correspond to markings on the cervical dilator device to allow the user to determine how far the device has been inserted into the subject. 
         [0040]    In an embodiment, dilation of the cervix of a subject may be accomplished by placing the devices described herein through the cervix of the subject such that the balloon is in the uterus of the subject. An insertion device may be used to assist positioning of the cervical ripening device in the subject. Once positioned, a support device of the cervix dilator device may be coupled to the subject. The balloon is then inflated by passing fluid through the elongated tube. The inflated balloon is thus positioned against the internal os of the cervix. To improve dilation of the cervix, the elongated tube is moved in a direction away from the cervix. This “pulls” the balloon against the cervix, creating an environment that encourages dilation of the cervix. In one embodiment, the cervical ripening device includes a threaded collar which is coupled to threading on the elongated tube. Adjustment of the threaded collar alters the position of the elongated tube with respect to the support and therefore with respect to the cervix. In this manner, the amount of pressure placed against the cervix by the balloon may be altered. 
         [0041]    In one embodiment, the device may be placed into the cervix with speculum or by digital exam. The catheter may be placed with the speculum or by digital guidance into the cervical os and advancing the catheter until it is in the cervix about 2 cms. After the catheter is in place, the guide is removed and the catheter is held in position. Using a syringe with sterile water, water is placed into the appropriate tube while the catheter is held in place. Once the balloon is inflated and determined to be at the internal os, the catheter is then attached to the supporting device and the desired traction is created. 
         [0042]      FIG. 5  depicts a kit that includes components that are used to induce dilation of the cervix of a subject. Kit  500  includes a cervical ripening device  510 , a support device  520 , and one or more syringes  530  used to inject fluids into the balloon. An inserter (not shown) may also be included with the kit. 
         [0043]    While the primary use of the device is for cervical ripening, the device may also be used for other in utero procedures. For example, the device may be used to withdraw body fluids from within the womb, through the same aperture that is used to inject the amniotic saline infusion. Furthermore, along with amniotic saline infusion, medications may also be injected into the uterus through the same tube. In some embodiments, the device may include tow or more inlet/outlet ports that extend into the uterus when the device is positioned in the subject. 
         [0044]    Further modifications and alternative embodiments of various aspects of the invention will be apparent to those skilled in the art in view of this description. Accordingly, this description is to be construed as illustrative only and is for the purpose of teaching those skilled in the art the general manner of carrying out the invention. It is to be understood that the forms of the invention shown and described herein are to be taken as examples of embodiments. Elements and materials may be substituted for those illustrated and described herein, parts and processes may be reversed, and certain features of the invention may be utilized independently, all as would be apparent to one skilled in the art after having the benefit of this description of the invention. Changes may be made in the elements described herein without departing from the spirit and scope of the invention as described in the following claims.