Patent Publication Number: US-2021169371-A1

Title: Cervical Dilation/Dilatation Measurement System of the Uterine Cervix During the Labor of Pregnant Women and Methods of Use

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
     This application claims the benefit of priority to U.S. Provisional Application No. 62/581,152 and PCT Application US2018059162 entitled “Cervical Dilation/Dilatation Measurement System of the Uterine Cervix During the Labor of Pregnant Women and Methods of Use,” filed on Nov. 3, 2017 and Nov. 5, 2018 respectively, the contents of which are hereby incorporated by reference in their entirety. 
    
    
     BACKGROUND THE INVENTION 
     Pregnant women routinely undergo multiple pelvic examinations during labor to determine the dilatation of the cervix to monitor the progress of their labor. Current evaluations and measurements of the cervix are done manually by inserting one or both of the index and middle fingers into the vagina of the patient. However, this repeated manual vaginal examination of the cervix is painful/uncomfortable, invasive, subjective, and inaccurate depending on the different medical providers evaluating the cervix and the progress of labor. The dilation of the cervix cannot be measured continuously in a reliable manner if it is done manually. 
     Further, the traditional manual evaluation to determine the dilatation of the cervix may increase the risk of vaginal infection, post-partum infection, minor and major, including death of the patient. Therefore, a device and corresponding procedure that is less invasive and simultaneously eliminates inaccuracies, variations, human error, and subjectivity of measuring and reporting the dilatation of the cervix during labor is desirable. This device will substantially decrease the associated morbidity and mortality of repeated pelvic examinations. 
     SUMMARY OF THE INVENTION 
     The present disclosure relates to an improved cervical dilation/dilatation measurement system of a uterine cervix of pregnant women during labor and methods of use thereof that enables a medical provider to continuously monitor the dilation/dilatation of the uterine cervix to monitor the progress of their labor. 
     Thus, in a first aspect, the present invention provides an apparatus consisting of (a) a first clip configured to move between an open position and a closed position, (b) a second clip configured to move between an open position and a closed position, (c) an elongated connector that is semi-rigid and deformable and that has a first end and a second end, where the first end of the elongated connector is coupled to the first clip, and where the second end of the elongated connector is coupled to the second clip, and (d) a sensor coupled to the elongated connector between the first end and the second end. 
     In a second aspect, the present invention provides a method consisting of (a) attaching the first clip of the apparatus according to the first aspect to a first extent of a cervix of a patient, (b) attaching the second clip of the apparatus according to the first aspect to a second extent of the cervix, where the second extent of the cervix is opposite the first extent of the cervix, and (c) determining, based on a measurement from the sensor, a distance between the first clip and the second clip. 
     These as well as other aspects, advantages, and alternatives, will become apparent to those of ordinary skill in the art by reading the following detailed description, with reference where appropriate to the accompanying drawings. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  illustrates an apparatus in a deployment position, according to an example embodiment. 
         FIG. 2A  illustrates an example clip of the apparatus of  FIG. 1  in a closed position, according to an example embodiment. 
         FIG. 2B  illustrates an example clip of the apparatus of  FIG. 1  in an open position, according to an example embodiment. 
         FIG. 3  illustrates an example actuator of the apparatus of  FIG. 1 , according to an example embodiment. 
         FIG. 4  illustrates the apparatus of  FIG. 1  in a deployed position, according to an example embodiment. 
         FIG. 5  illustrates another example apparatus in a deployment position, according to an example embodiment. 
         FIG. 6  illustrates the apparatus of  FIG. 1  in a deployed position at a first time, in accordance with one embodiment of the invention. 
         FIG. 7  illustrates the apparatus of  FIG. 1  in the deployed position at a second time, in accordance with one embodiment of the invention. 
         FIG. 8  is a schematic drawing of a computer network infrastructure, according to an example embodiment. 
         FIG. 9  is a flow chart depicting functions carried out in accordance with example embodiments of the disclosed methods. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     Exemplary devices and methods are described herein. It should be understood that the word “exemplary” is used herein to mean “serving as an example, instance, or illustration.” Any embodiment or feature described herein as “exemplary” is not necessarily to be construed as preferred or advantageous over other embodiments or features. The exemplary embodiments described herein are not meant to be limiting. One of ordinary skill in the art will readily understand that certain aspects of the disclosed systems and methods can be arranged and combined in a wide variety of different configurations, all of which are contemplated herein. 
     Furthermore, the particular arrangements shown in the Figures should not be viewed as limiting. It should be understood that other embodiments may include more or less of each element shown in a given Figure. Further, some of the illustrated elements may be combined or omitted. Yet further, an exemplary embodiment may include elements that are not illustrated in the Figures. 
     As used herein, with respect to measurements, “about” means +/−5%. 
     As used herein, “semi-rigid” means a structure that is stiff and solid to maintain its shape in the absence of an external force, but not inflexible such that it can change shape in response to an external force. 
     As used herein, “deformable” means a structure that can change its shape while being acted upon by any kind of external force. 
     As used herein, a “catheter” is an apparatus that is connected to a deployment mechanism and houses a medical device. The catheter may be used for delivering the apparatus described herein to the cervix. A catheter can have braided metal strands within the catheter wall to maintain structural integrity. The structural elements of the tip of the catheter can be bonded or laser welded to the braided strands of the catheter to improve the performance characteristics of the catheter tip. 
     As used herein, “lumen” refers to a passage in a tubular housing or a catheter through which a medical device may be disposed. 
     As used herein, “dilation” and “dilatation” may be used interchangeably to describe the size of an opening of a uterine cervix of a pregnant woman in labor. 
     As used herein, “electrical connection” means a wired connection, wireless connection, optical connection, or any other connection between two components such that the two components can share data between each other. 
     As used herein, “adjacent to the cervix in the vagina” means in the vicinity of the cervix in the vagina, nearby the cervix in the vagina, or close to the cervix in the vagina. 
     As used herein, “extent of the cervix” refers to an edge of the external orifice of the cervix. A distance between opposing extents of the cervix define a degree of cervical dilatation/dilation. 
     As used herein, “medical provider” means a doctor of medicine (M.D.), a registered nurse (R.N.), a certified nurse-midwife (C.N.M.), a medical student, mid-wife or any other provider. 
     As used herein, “coupled” means associated directly as well as indirectly. For example, a member A may be directly associated with a member B, or may be indirectly associated therewith, e.g., via another member C. It will be understood that not all relationships among the various disclosed elements are necessarily represented. 
     Unless otherwise indicated, the terms “first,” “second,” etc. are used herein merely as labels, and are not intended to impose ordinal, positional, or hierarchical requirements on the items to which these terms refer. Moreover, reference to, e.g., a “second” item does not require or preclude the existence of, e.g., a “first” or lower-numbered item, and/or, e.g., a “third” or higher-numbered item. 
     Reference herein to “one embodiment” or “one example” means that one or more feature, structure, or characteristic described in connection with the example is included in at least one implementation. The phrases “one embodiment” or “one example” in various places in the specification may or may not be referring to the same example. 
     As used herein, a system, apparatus, device, structure, article, element, component, or hardware “configured to” perform a specified function is indeed capable of performing the specified function without any alteration, rather than merely having potential to perform the specified function after further modification. In other words, the system, apparatus, structure, article, element, component, or hardware “configured to” perform a specified function is specifically selected, created, implemented, utilized, programmed, and/or designed for the purpose of performing the specified function. As used herein, “configured to” denotes existing characteristics of a system, apparatus, structure, article, element, component, or hardware which enable the system, apparatus, structure, article, element, component, or hardware to perform the specified function without further modification. For purposes of this disclosure, a system, apparatus, structure, article, element, component, or hardware described as being “configured to” perform a particular function may additionally or alternatively be described as being “adapted to” and/or as being “operative to” perform that function. 
     With reference to the Figures,  FIG. 1  illustrates an example apparatus  100  including a first clip  102  configured to move between an open position and a closed position, and a second clip  104  configured to move between an open position and a closed position.  FIGS. 2A-2B  illustrates an example clip, according to an example embodiment. Both the first clip  102  and the second clip  104  may have a similar structure to the clip shown in  FIGS. 2A-2B . Each of the first clip  102  and the second clip  104  have a pair of gripping arms  108 ,  110  that have a gripping length  112  ranging from about 1 mm to about 3 cm or any other appropriate length, and a gripping width  114  ranging from about 1 mm to about 3 cm or any other appropriate width. 
     In one example, the first clip  102  and the second clip  104  may each include a pair of gripping arms  108 ,  110  that are biased to the closed position via a spring  116 . 
     The first and second clips  102 ,  104  may have two ends, a gripping end  118  and a pinching end  120 . Such a spring  116  may be a torsion spring positioned between the gripping end  118  and the pinching end  120  of the first and second clips  102 ,  104 . The pinching end  120  of the first and second clips  102 ,  104  may be spaced apart when the first and second clips  102 ,  104  are in the closed position. The first and second clips  102 ,  104  may be transitioned from the closed position (shown in Figured  2 A) to the open position (shown in  FIG. 2B ) by squeezing the pair of gripping arms  108 ,  110  together at the pinching end  120 . In such an example, the first and second clips  102 ,  104  may be sized such that the first and second clips  102 ,  104  extend from the cervix in the vagina to outside of the vagina, such that a medical provider could open and close the first and second clips  102 ,  104  manually from outside of the vagina. 
     In one example, an inner surface  122  of each of the first clip  102  and the second clip  104  is substantially smooth. In another example, an inner surface  122  of each of the first clip  102  and the second clip  104  may include ridges or teeth  124  to grip an extent of the cervix that is positioned between the gripping arms  108 ,  110  of the first and second clips  102 ,  104 . 
     The ridges or teeth  124  may comprise a different material than the gripping arms  108 ,  110  of the first and second clips  102 ,  104 . For example, the ridges or teeth  124  may comprise a biocompatible material. In another example, the ridges or teeth  124  may be the same material as the gripping arms  108 ,  110  of the first and second clips  102 ,  104 . Other configurations are possible as well. 
     The apparatus  100  may further include an elongated connector  126  that is semi-rigid and deformable and that has a first end  128  and a second end  130 , as more clearly shown in  FIGS. 6 and 7 . The deformable property of the elongated connector  126  enables the elongated connector  126  to expand and change shape after it is connected to the cervix. 
     As shown in  FIG. 1 , the first end  128  of the elongated connector  126  is coupled to the first clip  102 , and the second end  130  of the elongated connector  126  is coupled to the second clip  104 . The apparatus  100  may further include a sensor  132  coupled to the elongated connector  126  between the first end  128  and the second end  130 . The sensor  132  may be positioned on an exterior surface of the elongated connector, or may be embedded in the elongated connector  126 . The semi-rigid property of the elongated connector  126  enables the elongated connector  126  to have an unstressed length and shape that is known, and this known length and shape of the unstressed elongated connector  126  enables a “zeroing” of the sensor  132  prior to or just after attachment of the apparatus to the cervix. In one example, the sensor  132  may be a linear displacement sensor. In another example, the sensor  132  may be an angular displacement sensor. As other examples, the sensor  132  may include magnetoresistive (MR) sensors, fluxgate magnetometers, or Hall effect sensors. Other examples are possible as well. 
     As shown in  FIG. 1 , the apparatus  100  may further include an applicator or actuator  134  coupled to the first clip  102  and the second clip  104 . The actuator  134  may be configured to move the first clip  102  and the second clip  104  between the open position and the closed position. The actuator  134  need not be directly attached to the first and second clips  102 ,  104 , but may be connected in an indirect manner with other elements in between them. The actuator  134  may be any mechanism capable of moving the first and second clips  102 ,  104  between the open and closed positions. 
     In one example, shown in  FIG. 3 , the actuator  134  may include a handle  136  for grasping by a medical provider, including a stationary arm  138  and a lever arm  140 . The lever arm  140  may be coupled to a rod  142 , which extends from the handle  136  to the first and second clips  102 ,  104  and is coupled to the first and second clips  102 ,  104  at the distal end of the rod  142 . Squeezing the handle  136  of the actuator  134  closed causes the rod  142  to slide in the proximal direction and causes the first and second clips  102 ,  104  to close. Opening the handle  136  causes the first and second clips  102 ,  104  to open. The handle  136  may also be a ratcheting handle, as shown in  FIG. 3 , to lock the handle  136 , and the first and second clips  102 ,  104  in place. 
     In further examples, the handle  136  of the actuator  134  may be spring biased, such that the first and second clips  102 ,  104  are biased in a closed position. Other configurations and examples of the actuator  134  are contemplated. The actuator  134  may be removably coupled to the apparatus  100  via a connector mechanism  135 , such that once the apparatus  100  is deployed, the actuator  134  can be decoupled from the apparatus  100 . Using the example described above, the handle  136  may be removably coupled from the rod  142  of the actuator  134 . For example, the handle  136  may include a threaded connection with the rod  142 , such that the two components can be unscrewed to detach them from one another. In another example, the handle  136  may be removably press fit into the rod  142  of the actuator  134 . Other connector mechanisms  135  are possible as well. The arrangement of a removable actuator  134  provides additional comfort and maneuverability of the patient after coupling the first and second clips  102 ,  104  to the cervix of the patient. 
     In one example, as shown in  FIG. 1 , a single trigger mechanism  148  is configured to move both the first clip  102  and the second clip  104  between the open position and the closed position, either simultaneously or in succession. In such an example, the single trigger mechanism  148  may comprise a single handle, a single lever, or a single button. In another example, as shown in  FIG. 4 , the actuator  134  comprises a first trigger mechanism  144  configured to move the first clip  102  between the open position and the closed position, and the actuator  134  further comprises a second trigger mechanism  146  configured to move the second clip  104  between the open position and the closed position. In one example, the first and second trigger mechanisms  144 ,  146  may include two separate handles. In another example, the first and second trigger mechanisms  144 ,  146  may include two levers (as shown in  FIG. 4 ) or two separate buttons. 
     In yet another example, as shown in  FIG. 5 , the apparatus  100  includes a first actuator  134 A coupled to the first clip  102  and a second actuator  134 B coupled to the second clip  104 . In such an example, the first actuator  134 A is configured to move the first clip  102  between the open position and the closed position, and the second actuator  134 B is configured to move the second clip between the open position and the closed position, either simultaneously or in succession. In such an example, both the first actuator  134 A and the second actuator  134 B may be removably coupled to the apparatus  100 , as discussed above. In one example, each of the first actuator  134 A and the second actuator  134 B may be similarly arranged to the handle  136  described above in relation to  FIG. 3 . 
     As shown in  FIG. 1 , the apparatus  100  may further include an introducer catheter  150  having a lumen  152 . In such an example, each of the first clip  102 , the second clip  104 , the elongated connector  126 , and the sensor  132  are positioned at least partially within the lumen  152  of the introducer catheter  150  in a deployment position. The introducer catheter  150  may have a diameter ranging from about 1 mm to about 2 cm, and preferably between about 4 mm and about 10 mm, for example only and not by way of limitation. 
     The introducer catheter  150  may be straight, curved, or angled, as examples. As shown in  FIG. 4 , in use the apparatus  100  may transition from the deployment position to a deployed position such that each of the first clip  102 , the second clip  104 , the elongated connector  126 , and the sensor  132  are positioned outside of the lumen  152  of the introducer catheter  150  in the deployed position. Such a position may be achieved by retracting the introducer catheter  150  with respect to the first clip  102  and the second clip  104 , or by advancing the first clip  102  and the second clip  104  with respect to the introducer catheter  150 . 
     The elongated connector  126  may take various forms, including a cable, wire, band, or ribbon as examples. In one example, the elongated connector  126  comprises a shape memory material, for example, nitinol (nickel-titanium), titanium, titanium alloys, copper-aluminum-nickel alloys, various plastics, or any other suitable material capable of retaining shape memory. The shape memory material of the semi-rigid deformable elongated connector  126  may be biased to have a U-shape. 
     As shown in  FIG. 6 , the semi-rigid deformable elongated connector  126  at time (t) has a natural, unstressed U-shape such that there is a distance  156  between the first clip and the second clip. Time (t) is either before attaching the apparatus  100  to a cervix of a patient or immediately after attaching the apparatus to the cervix of the patient. The sensor  132  may be “zeroed” at time (t) as the semi-rigid deformable elongated connector  126  may have a known distance  156  at time (t) prior to attaching the apparatus to a cervix of a patient. 
     In one example, the distance  156  is approximately 2 cm. Such a distance  156  may correspond to a cervix that is not dilated, or is just beginning to dilate during labor.  FIG. 7  illustrates elongated connector  126  at a second point in time (t&gt;0). At time t&gt;0, the cervix has dilated such that the distance  158  between the first clip  102  and the second clip  104  is greater than the initial distance  156 . 
     The apparatus  100  may further include a processor  160  in communication with the sensor  132 , as shown in  FIGS. 1 and 4 . The processor  160  may be configured to determine the distance between the first clip  102  and the second clip  104  based on a reading from the sensor  132 . In particular, the processor  160  may receive a change in resistance or other change in property of the sensor  132  based on the change in distance between the first clip  102  and the second clip  104  that causes the elongated connector  126  to change its shape, and may be configured to determine the distance between the first clip  102  and the second clip  104  based on that change in resistance. In operation, as the first and second clips  102 ,  104  are attached to opposite sides of the cervix when in use, the measured distance between the first clip  102  and the second clip  104  is an indication of a dilation of a uterine cervix of a pregnant woman in labor. 
     The apparatus  100  may be configured to monitor this process continuously, or may measure the distance between the first clip  102  and the second clip  104  periodically, such as every minute, every five minutes, or every ten minutes as examples. In one example, the processor  160  is in communication with the sensor  132  of the apparatus  100  via an electrical connection  106 . Such an electrical connection  106  may be a wired connection (as shown in  FIGS. 1 and 4 ), a wireless connection, an optical connection, or any other connection between the sensor  132  and the processor  160  such that the sensor  132  and processor  160  can share data between each other. In the case where the electrical connection  106  is a wired connection, the wire may be secured to the leg of the patient with a holder to prevent dislodgement or displacement of the apparatus  100  during labor. 
       FIG. 8  illustrates an example schematic drawing of a computer network infrastructure that may be in communication with one or more components of the apparatus  100  described above. In one system  200 , a computing device  205  communicates with the sensor  132  of the apparatus  100  using a communication link  204 , such as a wired or wireless connection. The computing device  202  may be any type of device that can receive data and display information corresponding to or associated with the data. For example, the computing device  202  may be a mobile phone, a tablet, or a personal computer as examples. 
     Thus, the computing device  202  may include a display system  206  comprising a processor  208  and a display  210 . The display  210  may be, for example, an optical see-through display, an optical see-around display, or a video see-through display. The processor  208  may receive data from the sensor  132 , and configure the data for display on the display  210 . For example, the display  210  may provide a graph illustrating the dilation of the cervix of the patient on the y-axis, with time on the x-axis. Such a graph may be printed in paper for review by the medical provider. Depending on the desired configuration, processor  208  can be any type of processor including, but not limited to, a microprocessor, a microcontroller, a digital signal processor, or any combination thereof. 
     The computing device  202  may further include on-board data storage, such as memory  212  coupled to the processor  208 . The memory  212  may store software that can be accessed and executed by the processor  208 , for example. The memory  212  can include any type of memory now known or later developed including but not limited to volatile memory (such as RAM), non-volatile memory (such as ROM, flash memory, etc.) or any combination thereof. 
     According to an example embodiment, the computing device  202  may include program instructions that are stored in the memory  212  (and/or possibly in another data-storage medium) and executable by the processor  208  to facilitate the various functions described herein. Although various components of the system  200  are shown as distributed components, it should be understood that any of such components may be physically integrated and/or distributed according to the desired configuration of the computing system. 
     The sensor  132  and the computing device  202  may contain hardware to enable the communication link  204 , such as processors, transmitters, receivers, antennas, etc. 
     In  FIG. 8 , the communication link  204  is illustrated as a wired connection; however, a wireless connection may also be used. For example, the communication link  204  may be a wired link via a serial bus such as a universal serial bus or a parallel bus. A wired connection may be a proprietary connection as well. The communication link  204  may also be a wireless connection using, e.g., Bluetooth® radio technology, communication protocols described in IEEE 802.11 (including any IEEE 802.11 revisions), Cellular technology (such as GSM, CDMA, UMTS, EV-DO, WiMAX, or LTE), or Zigbee® technology, among other possibilities. 
       FIG. 9  is a block diagram of an example method for measuring cervical dilation/dilatation of the uterine cervix during the labor of pregnant women. Method  300  shown in  FIG. 9  presents an embodiment of a method that could be used by the apparatus  100  of  FIGS. 1-6 , as described above for example only and not by limitation. Method  300  may include one or more operations, functions, or actions as illustrated by one or more of blocks  302 - 306 . Although the blocks are illustrated in a sequential order, these blocks may also be performed in parallel, and/or in a different order than those described herein. Also, the various blocks may be combined into fewer blocks, divided into additional blocks, and/or removed based upon the desired implementation. 
     Initially, at block  302 , the method  300  includes attaching the first clip  102  of the apparatus  100  as described above in relation to  FIGS. 1-6  to a first extent of a cervix. The method  300  continues with attaching the second clip  104  of the apparatus  100  as described above in relation to  FIGS. 1-6  to a second extent of the cervix, where the second extent of the cervix is opposite the first extent of the cervix. As the cervix is approximately circular in shape, positioning the first clip  102  and the second clip  104  on opposite extents of the cervix means that the first clip  102  and the second clip  104  are positioned approximately one hundred-eighty degrees apart. Such an arrangement helps measure the maximum dilation of the cervix. The method  300  continues with determining, based on a measurement from the sensor  132 , a distance between the first clip  102  and the second clip  104 . 
     In one example, attaching the first clip  102  to the first extent of the cervix includes (i) transitioning the first clip  102  from the closed position to the open position, (ii) positioning a portion of the first extent of the cervix between two gripping arms  108 ,  110  of the first clip  102 , and (iii) transitioning the first clip  102  to the closed position to thereby attach the first clip  102  to the first extent of the cervix, and attaching the second clip  104  to the second extent of the cervix includes (i) transitioning the second clip  104  from the closed position to the open position, (ii) positioning a portion of the second extent of the cervix between two gripping arms  108 ,  110  of the second clip, and (iii) transitioning the second clip  104  to the closed position to thereby attach the second clip  104  to the second extent of the cervix. 
     In one example, as described above, the apparatus  100  further includes an actuator  134  coupled to the first clip  102  and the second clip  104 . In such an example, transitioning the first clip  102  from the closed position to the open position includes actuating the actuator  134  in response to a first signal, and transitioning the second clip  104  from the closed position to the open position includes actuating the actuator  134  in response to the first signal or a second signal. In one example, the first signal includes a first gripping of the handle  136  of the actuator  134  by a user as described above in relation to  FIG. 3 . In such an example, the second signal includes a second gripping of the handle  136  by the user. In another example, the first signal includes a wireless signal/electrical signal generated by a processor  160  that wirelessly actuates the first clip  102 , and the second signal includes a wireless signal/electrical signal generated by the processor  160  that wirelessly actuates the second clip  104 . The actuator  134  may be removably coupled to the apparatus  100 , such that once the first clip  102  is attached to the first extent of the cervix and the second clip  104  is attached to the second extent of the cervix, the actuator  134  can be decoupled from the apparatus  100 . As discussed above, such an arrangement provides additional comfort and maneuverability of the patient. 
     In yet another example, the apparatus  100  includes a first actuator  134 A coupled to the first clip  102  and a second actuator  134 B coupled to the second clip  104 . In such an example, transitioning the first clip  102  from the closed position to the open position includes actuating the first actuator  134 A in response to a first signal, and transitioning the second clip  104  from the closed position to the open position includes actuating the second actuator  134 B in response to a second signal. In such an example, both the first actuator  134 A and the second actuator  134 B may be removably coupled to the apparatus, such that once the first clip  102  is attached to the first extent of the cervix and the second clip  104  is attached to the second extent of the cervix, the first actuator  134 A and the second actuator  134 B can be decoupled from the apparatus  100 . 
     In one example, the method  300  further includes (i) transitioning the first clip  102  to the open position to thereby detach the first clip  102  from the first extent of the cervix, and (ii) transitioning the second clip  104  to the open position to thereby detach the second clip  104  from the second extent of the cervix. Once the apparatus  100  is detached from the cervix, the apparatus can be removed from the vagina of the patient. 
     In another example, the method  300  further includes, prior to attaching the first clip  102  and the second clip  104  to the cervix, introducing an introducer catheter  150  adjacent to the cervix in the vagina. The introducer catheter  150  includes a lumen  152 , and each of the first clip  102 , the second clip  104 , the elongated connector  126 , and the sensor  132  are positioned at least partially within a lumen  152  of the introducer catheter  150  in a deployment position and arranged in a U-shape. 
     In one example, the medical provider may position the introducer catheter  150  between their index and middle fingers. Then the medical provider may guide or position the introducer catheter  150  adjacent to the cervix in the vagina. Next the medical provider may retract the introducer catheter  150  with respect to the first clip  102  and the second clip  104  such that each of the first clip  102 , the second clip  104 , the elongated connector  126 , and the sensor  132  are positioned outside of the lumen  152  of the introducer catheter  150  in a deployed position. The medical provide may then guide the first clip  102  to one edge of the cervix to attach the first clip  102  thereto and guide the second clip  104  to an opposing edge of the cervix to attach the second clip  104  thereto. 
     In another example, the method  300  further includes, prior to attaching the first clip  102  and the second clip  104  to the cervix, inserting a vaginal speculum into the vagina of the patient. In such an example, the medical provider may visualize the cervix, and then under direct vision attach the first clip  102  to the first extent of the cervix and attach the second clip  104  to the second extent of the cervix. The vaginal speculum can then be removed from the patient&#39;s vagina. Such an example may be used without the introducer catheter  150  at all. In one such example, as discussed above, the first clip  102  and the second clip  104  may each include a pair of gripping arms  108 ,  110  that are biased to the closed position via a spring  116 . Such a spring  116  may be a torsion spring positioned between a gripping end  118  and a pinching end  120  of the first and second clips  102 ,  104 . The first and second clips may be transitioned from the closed position to the open position by squeezing the pair of gripping arms  108 ,  110  together at the pinching end  120 . 
     In one such example, the first and second clips  102 ,  104  may be sized such that the first and second clips  102 ,  104  extend from the cervix in the vagina to outside of the vagina, such that a medical provider could open and close the first and second clips  102 ,  104  manually from outside of the vagina. As such, with the cervix visible to the medical provider via the vaginal speculum, the medical provider may simply squeeze the pinching end  120  of the first clip  102  to open the gripping arms  108 ,  110  of the first clip  102 , position the first clip  102  adjacent to the first extent of the cervix, release the pinching end  120  of the first clip  102  to close the gripping arms  108 ,  110  around the first extent of the cervix, and then repeat the process for the second clip  104  to attach the second clip  104  to the second extent of the cervix. 
     In another example, the medical provider may use both the vaginal speculum and the introducer catheter  150 . In such an example, the medical professional may insert the vaginal speculum into the vagina of the patient and open the speculum to visualize the cervix. Then the medical professional may insert the introducer catheter  150  adjacent to the cervix in the vagina, as discussed above. 
     In the embodiments including the introducer catheter  150 , the method  300  may further include (i) retracting the introducer catheter  150  with respect to the first clip  102  and the second clip  104  such that each of the first clip  102 , the second clip  104 , the elongated connector  126 , and the sensor  132  are positioned outside of the lumen  152  of the introducer catheter  150  in a deployed position in a vagina of a patient, (ii) transitioning the first clip  102  to the open position to thereby detach the first clip  102  from the first extent of the cervix, (iii) transitioning the second clip  104  to the open position to thereby detach the second clip  104  from the second extent of the cervix, (iv) advancing the introducer catheter  150  with respect to the first clip  102  and the second clip  104  such that each of the first clip  102 , the second clip  104 , the elongated connector  126 , and the sensor  132  are positioned at least partially inside of the lumen  152  of the introducer catheter  150 , and (v) removing the introducer catheter  150  from the vagina of the patient. 
     The method  300  may further include (i) providing a display of a graph of the distance between the first clip  102  and the second clip  104  over time, and (ii) in response to the graph of the distance between the first clip  102  and the second clip  104 , determining and measuring a degree of cervical dilatation/dilation in relation to an amount of time elapsed. Such a display may provide valuable information of continuous monitoring of the degree of cervical dilatation/dilation on one axis of a graph with elapsed time on another axis of the graph, to thereby indicate the progress of the patient&#39;s labor. 
     Certainly, other medical devices such ultrasound technology may be used in association with the present invention in order effectuate the purposes of the invention described herein. 
     It will be appreciated that other arrangements are possible as well, including some arrangements that involve more or fewer steps than those described above, or steps in a different order than those described above. 
     While various aspects and embodiments have been disclosed herein, other aspects and embodiments will be apparent to those skilled in the art. All embodiments within and between different aspects of the invention can be combined unless the context clearly dictates otherwise. The various aspects and embodiments disclosed herein are for purposes of illustration and are not intended to be limiting, with the true scope and spirit being indicated by the following claims.