Abstract:
A catheter device for facilitating release of a structure lodged within a body cavity includes a flexible catheter and carrier configured to mount the catheter to a finger. The catheter includes a leading end having an opening configured to permit fluids within the catheter to exit the catheter, and a proximal end configured to connect to a fluid source. A method using the catheter device to release a fetal head from a maternal pelvis during cesarean delivery of the fetus is provided.

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application claims the benefit of U.S. Provisional Application No. 61/493,620, titled “Device for Assisting Cesarean Deliveries” filed Jun. 6, 2011. The contents of the above application are incorporated herein by reference. 
     
    
     BACKGROUND OF THE INVENTION 
       [0002]    The obstetrical challenge of the cesarean delivery after a long labor often includes difficulty in safely dislodging the impacted fetal head. While the occurrence of fetal cervical fracture during cesarean delivery is rare, fetal skull fracture and intracerebral hemorrhage, trauma to maternal tissues resulting in hemorrhage and bladder damage, and injury to the delivering obstetrician is not. As protracted labors and cesarean section rates rise, a simple but effective device to facilitate delivery is needed. 
       SUMMARY 
       [0003]    In some aspects, a device is provided for facilitating release of a structure lodged within a body cavity. The device includes a flexible catheter having a leading end, the leading end including an opening configured to permit fluids within the catheter to exit the catheter, and a carrier adjoining the leading end of the catheter and configured to mount the catheter to a finger. 
         [0004]    The device may include one or more of the following features: The flexible catheter further includes an internal fluid passage that extends from the leading end to an opposed end, and the opening communicates with the fluid passage. The flexible catheter further includes a body extending between the leading end and an opposed end, the body being tubular in shape including a tube width and a tube height that are the same in dimension, and the leading end having a width that is greater than the tube width and a height that is less than the tube height. The leading end includes a base that is wide relative to the width of the body, and a terminal end extending from the base, the width of the terminal end tapering from the base to an apex. The carrier is disposed on a side of the leading end. The leading end is generally flat on a side opposed to the carrier. The leading end flat side includes a raised pattern configured to enhance frictional engagement of the leading end flat side with a surface of the structure. The opening is disposed on a side of the leading end opposed to the carrier. The opening is triangular. The area defined by the periphery of the opening is greater than the cross-sectional area of the fluid passageway. The device is formed of silicon. The carrier is configured to surround at least the distal phalange of a finger. The carrier is configured to surround the distal phalange and middle phalange of a finger. The carrier is elastic. The opposed end of the catheter is configured to be connected to a fluid source. The opposed end of the catheter includes a connector having a thread configured to engage a corresponding thread on a fluid source. 
         [0005]    In some aspects, a device is provided for facilitating release of a structure lodged within a body cavity. The device includes a flexible body, the body having a fluid passageway, a first opening configured to receive a finger, a second opening configured to provide a fluid inlet to the passageway, and a third opening configured to permit fluids within the passageway to exit the body. 
         [0006]    The device may include one or more of the following features: The fluid passageway extends from the second opening to the third opening, and the first opening is isolated from the fluid passage. The body includes a tubular portion and has a tube width and a tube height that are the same dimension, the tubular portion extending between a proximal end that includes the second opening and an opposed leading end that includes the third opening, the leading end having a width that is greater than the tube width and a height that is less than the tube height. The leading end includes a base that is wide relative to the width of the body, and a terminal end extending from the base, the width of the terminal end tapering from the base to an apex. The first opening is disposed on a side of the leading end. The leading end is generally flat on a side opposed to the first opening. The flat side of the leading end includes a raised pattern configured to enhance frictional engagement of the flat side with a surface of the structure. The third opening is disposed on a side of the leading end opposed to the first opening. The third opening is triangular. The area defined by the periphery of the third opening is greater than a cross-sectional area of the fluid passageway. The body is formed of silicon. The first opening is configured to surround at least the distal phalange of a finger. The first opening is configured to surround the distal phalange and middle phalange of a finger. The portion of the body defining the first opening is elastic. The proximal end is configured to be connected to a fluid source. The proximal end includes a connector having a thread configured to engage a corresponding thread on a fluid source. 
         [0007]    In some aspects, a method of forming a device for facilitating release of a structure lodged within a body cavity is provided. The method includes providing a flexible catheter including a leading end, the leading end including an opening configured to permit fluids within the catheter to exit the catheter, and securing a carrier, configured to mount the catheter to a finger, to the catheter leading end. 
         [0008]    In some aspects, a method releasing a fetal head from the pelvis during cesarean delivery of the fetus is provided. The method includes insertion of a catheter into the pelvis via an abdominal incision so that a leading end of the catheter is disposed between the fetal head and the pelvis, injection of a fluid through the catheter into pelvis between the fetal head and the pelvis so as to facilitate release of the fetal head from the pelvis. In some embodiments, the catheter includes a finger carrier and the catheter is finger-mounted during insertion. 
         [0009]    A catheter is disclosed that advantageously facilitates release of a structure lodged within a body cavity by inserting a sterile irrigant between the structure and the body cavity so as to break a vacuum holding the structure within the body cavity. For example, in a cesarean delivery, the catheter is placed below the vertex at the time of delivery so as to provide a sterile irrigant between the fetal head and the maternal pelvis. Doing so breaks the vacuum holding the fetal head in the maternal pelvis and lavages the vertex upwards, permitting the practitioner to easily remove the fetal head from the pelvis, and complete the cesarean delivery. 
         [0010]    In certain embodiments, the catheter includes a finger carrier disposed adjacent the leading end of the catheter, permitting the catheter to be finger mounted. This configuration further advantageously permits finger-directed placement of the catheter in the body cavity, allowing proper placement despite tight space requirements. 
         [0011]    In certain embodiments, the catheter leading end is relatively wide and thin relative to the mid-section and proximal end of the catheter, facilitating insertion of the leading end into tight spaces between closely engaged structures. 
         [0012]    In certain embodiments, the leading end is generally flat on a side opposed to the finger carrier. The flat side is provided with surface features configured to enhance the ability of the practitioner to engage the structure to be dislodged from the body cavity. For example, the flat side may include raised ridges configured to enhance the user&#39;s ability to grip the fetal scalp while withdrawing the fetal skull from the maternal pelvis. In addition, by providing improved finger grip, less finger flexion force is required to achieve an adequate grip, further reducing trauma to the fetal skull. 
         [0013]    Modes for carrying out the present invention are explained below by reference to an embodiment of the present invention shown in the attached drawings. The above-mentioned object, other objects, characteristics and advantages of the present invention will become apparent from the detailed description of the embodiment of the invention presented below in conjunction with the attached drawings. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0014]      FIG. 1  is a schematic illustration of the catheter device being used to facilitate release of a fetal head impacted within a pelvic cavity during a cesarean delivery. 
           [0015]      FIG. 2  is a perspective view of the catheter device of  FIG. 1 . 
           [0016]      FIG. 3  is a perspective view of the tip portion of the catheter device of  FIG. 1 . 
           [0017]      FIG. 4  is a sectional view of the tubular portion as seen across line  4 - 4  of  FIG. 3 . 
           [0018]      FIGS. 5-7  are alternative embodiments of the tip portion as seen when viewed in the direction of arrow  7  of  FIG. 3 . 
           [0019]      FIG. 8  is a sectional view of the tip portion as seen across line  5 - 5  of  FIG. 3 . 
           [0020]      FIG. 9  is a sectional view of the tip portion as seen across line  6 - 6  of  FIG. 3 . 
       
    
    
     DETAILED DESCRIPTION 
       [0021]    Referring now to  FIGS. 1-3 , the catheter device  20  includes a tubular portion  22  including a proximal end  24  configured to be secured to a fluid supply  100 . The catheter device  20  includes a tip portion  40  that extends from a distal end  26  of the tubular portion, where the distal end  26  is opposed to the proximal end  24 . In addition, an internal fluid passageway  30  extends from the proximal end  24  to a terminus  54  of the tip portion  40 . As will be discussed in greater detail below, the tip portion  40  has a shape that is wide and flat relative to the tubular portion  22  to facilitate insertion of the catheter device  20  into tight spaces, and particularly between an object  8  and a body cavity surface  4  within which the object  8  is lodged. In addition, the tip portion  40  includes a carrier  80  so that the catheter device  20  can be mounted on, and directed by, a finger  2  during use, as also discussed further below. 
         [0022]    Referring to  FIG. 4 , the tubular portion  22  has a circular cross-sectional shape, whereby the height and width the section are of equal dimension. The passageway  30  extends coaxially with respect to a longitudinal centerline of the tubular portion  22 , and is also circular in cross-sectional shape. 
         [0023]    The tubular portion  22  is long relative to its cross-sectional diameter, which may be in a range of 0.1 inches to 0.4 inches. In particular, the tubular portion has sufficient length to permit the user to insert the tip portion  40  within a body cavity while the fluid supply  100  remains outside the body. In some embodiments, the tubular portion has a length of about 20 inches to allow the device  20  to extend from a finger tip to at least an elbow of the user. 
         [0024]    Referring again to  FIGS. 1-3 , in the illustrated embodiment, the fluid supply  100  is a manual syringe having a luer lock syringe tip  102 . The connector  32  provided on the tubular portion proximal end  24  includes the corresponding structure, including external threads  34 , for engaging the luer lock tip  102 . The locking engagement between the connector  32  and the fluid supply  100  is advantageous since it ensures a firm connection between the catheter device  20  and the fluid supply  100  even when fluid pressures generated by the fluid supply are relatively high, as may be required to expel fluid from the catheter tip portion  40  when the device  20  is used in a tight space. 
         [0025]    The tip portion  40  extends integrally from the distal end  26  of the tubular portion  22 . The tip portion  40  is wide and flat relative to the tubular portion  22 , so that it has a width that is greater than the tube width and a height that is less than the tube height. The tip portion  40  includes a dorsal surface  42  which supports the carrier  80 , and a ventral surface  44  opposed to the dorsal surface  42 . As viewed in the direction of the arrow  7  of  FIG. 3 , the tip portion  40  has a peripheral shape in the general form of a spade. That is, the tip portion  40  includes a wide base  52  that adjoins the tubular portion distal end  26 , and gradually reduces in width along an axial direction, so that the tip portion  40  terminates at the pointed apex  54 . Providing the tip portion  40  with a small, pointed leading end is advantageous for initiating insertion of the tip portion  40  into tight, confined spaces. 
         [0026]    Referring to  FIG. 5 , the ventral surface  44  is a generally planar surface and includes an opening  48  that extends through the surface  44  and communicates with the fluid passageway  30 . The opening  48  provides an outlet for the fluids supplied by the fluid supply  100  and has an area that is relatively large compared to the cross sectional area of the fluid passageway  30 . In the illustrated embodiment, the opening  48  is triangular in shape and an apex of the opening  48  is located at the tip portion apex  54 . In addition, the portions of the ventral surface  44  surrounding the opening  48  are smooth to facilitate insertion of the tip portion  40  into tight, confined spaces. 
         [0027]    The region of the ventral surface  44  between the opening  48  and that base  52  further includes surface features that enhance frictional engagement of the ventral surface  44  with a surface of the structure to be dislodged. In the illustrated embodiment, the surface features include an array of generally parallel, spaced-apart, protruding ridges  50  that extend generally in the width direction of the tip portion  40 . In the case of a cesarean delivery, where the fetal scalp  8  may be coated with vernix caseosa and bodily fluids, the ridges  50  improve the user&#39;s ability to grip the fetal skull  8 . By improving the user&#39;s ability to grip the skull  8 , less finger flexion force is required to hold the fetal skull  8  and/or move the fetal skull  8  relative to the maternal pelvis  4 . 
         [0028]    Referring to  FIGS. 6 and 7 , alternative surface features can be used to enhance frictional engagement by the ventral surface  44  of the catheter tip portion  40 . For example, the array of parallel spaced ridges  50  can be replaced by an array of spaced ridges in the form of concentric rings  50 ′ ( FIG. 6 ). In another example, the surface features may include providing a set of small, randomly raised dots  50 ″ ( FIG. 7 ). 
         [0029]    Referring to  FIGS. 3 and 8 , the carrier  80  is disposed on the dorsal surface  42  of the tip portion  40 , and is a hollow, elastic, resilient, generally tubular structure. The carrier  80  has an open end  82  adjacent the base  52 , and a closed end  84  adjacent to the apex  54 . The carrier closed end  84  is formed so as to taper toward the dorsal surface  42 , to facilitate insertion of the tip portion into tight spaces. The hollow interior space  88  is dimensioned to receive a portion of a finger, and the carrier length, defined as the distance between the open end  82  and the closed end  84 , is sufficient to surround at least the distal phalange of an adult finger  2 . In some embodiments, the carrier length is sufficient to surround at least the distal phalange and middle phalange of an adult finger  2 . The cross-sectional dimension of the carrier  80  is slightly less than an adult finger  2  so that in use, the carrier  80  is radially stretched when finger-mounted so that friction force and carrier elasticity securely retain the carrier  80  on the finger  2 . 
         [0030]    The tubular portion  22  and the tip portion  40  of the catheter device  20  are formed of a polymer such as silicone or urethane. In the illustrated embodiment, the carrier  80  is integrally formed as a single unit with the tip portion  40  and tubular portion  20 . It is understood, however, that the carrier  80  and/or tip portion  40  may be formed individually and assembled to the tubular portion  22 . Coatings may be applied to the device outer surface at at least some locations to improve surface friction properties. For example, at some locations, a lubricant may be applied to reduce device surface friction and enhance the insertability of the device  20  into tight spaces. At other locations, an adhesive may be applied to improve localized gripability. 
         [0031]    In use, the catheter device  20  facilitates release of a structure lodged within a body cavity by inserting a sterile irrigant between the structure and the body cavity so as to break a vacuum holding the structure within the body cavity. For example, in a cesarean delivery where the fetal head  8  is lodged within a maternal pelvis, the catheter device is mounted on a finger  2 , for example the middle finger, of a user so that the tip portion  40  resides on a palmar side of the finger  2 . Specifically, the catheter device  20  is oriented relative to the finger  2  so that palmar surface of the finger  2  overlies the tip portion dorsal surface  42 , and the tip portion ventral surface  42  faces away from the palmar surface of the finger  2 . In this configuration, the ventral surface  42  can confront the fetal skull  8 . The catheter device  20 , including the tip portion  40  mounted on the user&#39;s finger  2 , is inserted into the maternal pelvis via an abdominal incision so that the tip portion  40  is disposed between the fetal head  8  and the pelvis  4 , and at least the proximal end  24  of the tubular portion  22  and the fluid supply  100  resides externally relative to the abdominal incision. In some embodiments, the tip portion  40  is advanced to the fetal skull vertex  10 . Once the tip portion  40  is in position, sterile fluid is injected through the catheter fluid passageway  30  and exits from the catheter device  20  via the opening  48  into pelvis between the fetal head  8  and the pelvis  4  so as to facilitate release of the fetal head from the pelvis, for example by relieving a region of low pressure between the maternal pelvis  4  and fetal head  8 . If necessary, the fluid may be pressurized to facilitate sufficient flow quantities and/or rates. The injected fluid breaks the vacuum holding the fetal head in the pelvis and lavages the vertex upwards. Once the vacuum is released, the user&#39;s finger tips, including the finger  2  carrying the catheter device  20 , are flexed to withdraw the fetal head  8  from the pelvis  4 . 
         [0032]    In the illustrated embodiment, the catheter device  20  is described for use in cesarean deliveries to facilitate the release of an impacted fetal head. It is understood, however, that the device may be used to facilitate release of other structures lodged within body cavities. For example, the catheter device may be used to facilitate release of a pessary. 
         [0033]    Although in the illustrated embodiment, the tubular portion  22  and fluid passageway  30  each have a circular cross-sectional shape, it is understood that the tubular portion  22  of the catheter device  20  is not limited to this shape. For example, the tubular portion  22  and/or fluid passageway  30  may have polygonal or oval cross-sectional shapes. 
         [0034]    In the illustrated embodiment, the fluid supply  100  is a manual syringe having a luer lock syringe tip. However, the fluid supply  100  is not limited to this type of syringe, and may be replaced with, for example, a syringe having different syringe tips. Moreover, the fluid supply  100  is not limited to a syringe, and may be replaced with system including a pump connected to a fluid reservoir. 
         [0035]    In the illustrated embodiment the carrier  80  is shaped and dimensioned for mounting on a user&#39;s finger. The carrier is not limited to this configuration. For example, the carrier may be in the form of a glove worn on a user&#39;s hand, with the catheter leading end  40  secured to a palmar side of a glove finger. 
         [0036]    Although in the illustrated embodiment, the opening  48  in the tip portion  40  is a single opening that is triangular in shape, it is understood that the opening  48  is not limited to this configuration. For example, an alternative configuration may include an array of small circular openings  48 ′ arranged in the vicinity of the apex  54  (see  FIG. 6 ). In another example, another alternative configuration may include plural elongated, mutually-diverging openings  48 ″ arranged in the vicinity of the apex  54  (see  FIG. 7 ). 
         [0037]    A selected illustrative embodiment of the invention is described above in some detail. It should be understood that only structures considered necessary for clarifying the present invention have been described herein. Other conventional structures, and those of ancillary and auxiliary components of the system, are assumed to be known and understood by those skilled in the art. Moreover, while a working example of the present invention has been described above, the present invention is not limited to the working example described above, but various design alterations may be carried out without departing from the present invention as set forth in the claims.