Patent Publication Number: US-9848911-B1

Title: Birth ease method and device

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS, IF ANY 
     This application is a division of application Ser. No. 13/476,675 filed on May 21, 2012. Application Ser. No. 13/476,675 now U.S. Pat. No. 9,265,527, is hereby incorporated by reference. 
    
    
     STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT 
     Not applicable. 
     REFERENCE TO A MICROFICHE APPENDIX, IF ANY 
     Not applicable. 
     BACKGROUND OF THE INVENTION 
     1. Field of the Invention 
     The present invention relates to a method for easing child birth and, more particularly, to a device for practicing the method for easing child birth and, most particularly, to a device for easing child birth, which is controlled by the individual giving birth to the child. 
     2. Background Information 
     Child birth is often a traumatic physical and emotional process that involves passage of the child through the birth canal of the mother. The process is nearly always painful and can put the well being of both the mother and child in jeopardy. Various medications can be used to ease the pain of the mother during the process, but such medications are not without risk to both the mother and child. Various mechanical devices have been developed to assist the child birth process. Several inventions concerned with devices that are applied to the exterior of the mother to assist in child birth have been granted patents. 
     Heidenwolf, in U.S. Pat. No. 2,597,637, describes an obstetrical apparatus that includes a belt with an inflatable bladder that is secured around the abdomen of a parturient woman. The belt is positioned such that inflation of the bladder applies pressure toward the belly between the hips and bottom of the uterus of the woman. The belt is held in place by a strap that is secured to the upper thigh of the woman. 
     In U.S. Pat. No. 4,576,154, Hyman et al. disclose an orthopedic belt that eases sacroiliac joint pain by compressing soft pelvic tissue against the sacrum and ilium, to support and immobilize the sacroiliac joints. The belt consists solely of flat, woven webbing forming a band about four to six inches wide, and a fastening device at the front. The belt encircles the patient at the level between the anterior superior iliac spines and the greater trochanters of the femurs. It is fastened with enough tension to compress the soft tissue, as desired. Ends of the band forming the belt are fastened together at an angle, which is selected to pass the belt horizontally across the back and to accommodate the shape of the patient&#39;s hips. The ends of the band are cut off in a taper so that no square corners are exposed. Various fastening means to place and maintain tension on the band may be used, including flexible straps extending from one end of the band through loops on the other and back to the first end, where they are connected together with cooperating press-holding pads such as Velcro™ hook and eye material. 
     Sebastian et al., in U.S. Pat. No. 4,836,194, describe a therapeutic appliance for application to the lumbar spine. The appliance follows the contours of the iliac crests and overlies the sacrum and sacroiliac joints, as well as anchors below the posterior superior iliac spines of the human body. The appliance includes an external shell having a length sufficient to extend around the abdominal region of the body with fasteners at opposite ends of the shell and an air bladder disposed on the shell. The air bladder has a plurality of air chambers, including elongated air chambers which extend transversely to the longitudinal direction of the shell with lower ends thereof shaped to lie above the iliac crests. The device includes a lower longitudinally extending air chamber and an anchoring air chamber between the longitudinally extending air chamber and the outer edge of the bladder. The anchoring air chamber extends arcuately from a central portion of the air bladder toward the opposite ends of the shell and is positioned to lie below the posterior superior iliac spines to prevent upward riding of the therapeutic appliance when in place on the human body and to provide support for the sacroiliac joints. The appliance may also include belts on the outside thereof for tightening the air chambers against the wearer&#39;s lumbar spine and sacroiliac joints. Pockets can be provided on the inside of the appliance for applying hot or cold packs to the back muscles of the wearer of the appliance. 
     U.S. Pat. No. 5,174,281 by Lee discloses a pneumatic cuff assembly fitting over and around the entire maternal abdomen. The cuff is intermittently inflated to a low and safe pressure in synchrony with the mother&#39;s voluntary straining efforts in order to augment the intra-abdominal pressure to assist the delivery of the fetus at the final stage of child birth. Near the end of obstetric labor, the cuff is applied on the abdomen, parts are connected, and the reservoir tank pressurized to a recommended pressure of twenty pounds per square inch. At the final stage of delivery and synchronous with the mother&#39;s voluntary straining, the cuff is inflated. When the voluntary straining stops, the cuff is manually deflated quickly. The setting of the pressure reducer/regulator is to be determined by the physician or midwife. Two to four pounds per square inch seems appropriate. The amount of additional expelling force can be roughly estimated at two pounds per square inch of cuff pressure, which is considered low and safe, and at ten square inches of cross-sectional area of a fetal head, the force is twenty pounds, which is more than is safely applied with a pair of outlet forceps. Generally speaking, a pushing force is safer on the mother and the child then a pulling force. 
     In U.S. Pat. No. 5,405,356, Hahn et al. describe a childbirth-assisting device that uses an automatically synchronized, expandable pneumatic girdle to externally augment the secondary force of labor. The pneumatic girdle is fitted around the abdomen of the woman and the girdle is inflated to create a downward pressure on the abdomen when a contraction occurs. The synchronization of the girdle&#39;s inflation and the contractions is provided by an electronic controller, which receives a signal from an intra-uterine monitor indicating a contraction and causes the girdle to inflate at a certain rate until a preset intra-uterine pressure is attained. Once the intra-uterine pressure reaches the preset pressure, the girdle pressure is maintained until the offset of the contraction is detected, at which time the girdle is deflated. 
     Hahn et al., in U.S. Pat. Nos. 5,645,563 and 5,871,499, disclose a childbirth-assisting device that uses an automatically synchronized, expandable pneumatic girdle to externally augment the secondary force of labor. The girdle, through which the pressure is applied, is fitted around the abdomen of the woman. An inflatable bladder within the girdle is inflated to create a downward pressure on the abdomen upon detection of a contraction. External pressure monitors which detect contractions may be attached directly to the girdle, and the girdle is configured to assure that the bladder is correctly positioned at all times. The external pressure monitors include a solid state force sensor, embedded within a pliable housing, which is conformable to the patient&#39;s abdomen to improve accuracy. A member may be provided to prevent multiple uses of a girdle to assure the integrity of the girdle during use. 
     U.S. Pat. No. 5,928,175 by Tanaka discloses a medical corset that includes a hip band portion composed of an elastic material for covering both the sacroiliac region and the hip joint region and a pair of femoral region holding portions, coupled below the buttock portion of this hip band portion to be fixed on the thighs. When this corset is put on a body, the sacroiliac region and the hip joint region are compressed and protected by the hip band portion and, thus, a lame hip due to a trouble of these joints is lightened. When putting the medical corset on the body, the hip band portion is first wound around the hip region. The hip band portion, which is capable of entirely covering both the sacroiliac region and the hip joint region and is composed of an elastic material, keeps the hip region in a somewhat compressed condition. When the pair of femoral region holding means, coupled to the hip band portion, is fixed on the right and left thighs, the attachment of the medical corset is completed. In this condition, in which the femoral region holding means are fixed on the thighs and are coupled on the buttock side, the entire corset is prevented from shifting upward even if bending and stretching are repeated, for example. The buttock side is the region extending from the buttocks to the back. 
     Ha, in U.S. Patent Application Publication No. 2005/0242639, describes a pelvis remedial seat device and a control method thereof for remedying into its original place a woman&#39;s widened pelvis after child birth. The pelvis remedial seat device comprises a seat ( 10 ), a seat cushion ( 11 ) on which an occupant is seated and left/right seat sides ( 12   a ,  12   b ), provided uprightly at each side end of the seat cushion ( 11 ). A pair of air bags ( 20   a ,  20   b ) nested on an inner side of each side are expanded or contracted by air supplied into or discharged from the inside of the air bag. An air injection means for providing air pressure to the air bags ( 20   a ,  20   b ) is also present. The expanding air pressure in the air bags presses the pelvis portion of an occupant. Accordingly, the air pressure can artificially press the pelvis portion of the woman, when seated or lying down, without constraining the human body so that rapid recovery of the pelvis can be attained. 
     Applicants have devised a method for easing child birth and, more particularly, to a device for practicing the method for easing child birth and, most particularly, to a device for easing child birth, which is controlled by the individual giving birth to the child. 
     SUMMARY OF THE INVENTION 
     The invention is directed to a device to assist in the birth of a child. The birth ease device is designed to mechanically replace a “manual” contact, which can be applied to the pelvis of a woman in labor (delivering of a baby), for the purpose of aiding the expulsion of the baby, and also significantly reduce the pain and discomfort associated with this process. The birth ease device compresses the ilium portion of the pelvis medially and posteriorly, simultaneously. The pressure applied by the birth ease device is under full control of the patient, or a qualified technician, so that the pressure is applied slowly and progressively to a point of maximum comfort, but the pressure can be decreased immediately upon demand by the patient. Preferably, the duration of the application of compression corresponds with the length of the contraction period for the woman. 
     The birth ease device includes a pair of contact members that are contoured to fit the “ala” of the ilium and are adjustable to fit a range of sizes. The pair of opposed contact members each has an opposed concave surface therein forming a contact volume there between. Each opposed contact member includes a motive mechanism selectively actuated to vary the contact volume between the opposed contact members. A control mechanism is operatively connected to each opposed motive mechanism to selectively increase and decrease the contact volume between the opposed contact members. The motive mechanism is selectively controlled by the woman to increase and decrease the contact volume occupied by the woman&#39;s pelvis, thereby selectively applying and releasing pressure to the woman&#39;s pelvis, and assisting delivery of a child. 
     The birth ease device adds compressive pressure to the “ala” of the ilium. The medial pressure exerted by the birth ease device leverages the pelvis at the sacroiliac joints. This pressure is superior to a line drawn through the sacroiliac joints and causes reduced pressure inferior to this line, mainly affecting the symphysis pubis and the obturator foramen. The pressure applied by the concave, contact members eases the pressure exerted by the emerging head of the baby at the “obturator foramen.” The applied pressure significantly decreases the pain associated with the birth process and aids the efficiency of the baby&#39;s head in forcing the obturator to enlarge. 
     For safety purposes, the pressure applied by the birth ease device is applied slowly, while reduction of the pressure can be immediate and absolute. However, a slow reduction of pressure comparable to the rate of application is sufficient and preferable. The pressure applied has a maximum set point to assure that the patient cannot apply excessive pressure during a time of distress. 
     In a preferred embodiment of the invention, the birth ease device includes a pair of opposed contact members each having an opposed concave surface therein forming a contact volume there between. Each opposed contact member includes a rigid concave back plate member joined at an end to a rigid connector plate member, with each back plate member having an opposed concave surface. Each opposed contact member includes a motive mechanism selectively actuated to vary the contact volume between the opposed contact members. The motive mechanism includes a plurality of inflatable bladder members secured to the opposed concave surface of each back plate member by a flexible padding member secured thereto, with each inflatable bladder member operatively connected to a pressurized fluid source. A control mechanism is operatively connected to each opposed motive mechanism to selectively increase and decrease the contact volume between the opposed contact members. The control mechanism provides selective inflation and deflation of the inflatable bladder members by the pressurized fluid source. The concave surfaces of the flexible padding members of the contact members of the birth ease device are adapted for contact with a woman&#39;s pelvis during child birth. The inflatable bladder members of the motive mechanism are selectively controlled by the woman to increase and decrease the contact volume occupied by the woman&#39;s pelvis, thereby selectively applying and releasing pressure to the woman&#39;s pelvis, and assisting delivery of a child. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a perspective top view of the pelvis bone of a human, to which the device of the present invention is applied. 
         FIG. 2  is a perspective front view of one embodiment of the birth ease device of the present invention. 
         FIG. 3  is a perspective rear view of the birth ease device of  FIG. 2  of the present invention. 
         FIG. 4  is an exploded perspective front view of the embodiment of the birth ease device of  FIG. 1  of the present invention. 
         FIG. 5  is a perspective front view of the embodiment of the birth ease device of  FIG. 1  of the present invention as applied to a human pelvis bone. 
         FIG. 6  is a perspective view of the birth ease device of  FIG. 1  of the present invention positioned around the pelvis of a woman for assisting in child birth. 
         FIG. 7  is a schematic view of the motive mechanism and operatively connected control mechanism of the present invention. 
     
    
    
     DESCRIPTION OF THE EMBODIMENTS 
     Nomenclature 
     
         
         
           
               10  Birth Ease Device 
               20  Opposed Contact Members 
               22  Opposed Concave Surface of Contact Member 
               30  Rigid Concave Back Plate Members 
               32  Concave Surface of Back Plate Members 
               36  Rigid Ribbing of Back Plate Members 
               38  Aligned Apertures of Rigid Ribbing 
               40  Connector Plate Member 
               42  Hollow Cylinders 
               44  Fasteners for Connector Plate Members 
               50  Motive Mechanism 
               55  Inflatable Bladder Members 
               60  Flexible Padding Members 
               65  Fluid Conduit System 
               70  Control Valves for Bladder Members 
               75  Pressurized Fluid Reservoir 
               80  Control Mechanism 
               85  Master Control Valve 
               87  Pressure Regulators 
               90  Micro Controller Logic Circuit Member 
               95  Hand-Held Remote Control Member 
               98  Conductor Cord for Control Member 
             P Pelvis Bone 
             V Contact Volume Between Contact Members
 
Construction
 
           
         
       
    
     The invention is a device for easing child birth, which is controlled by the individual giving birth to the child. The birth ease device is designed to mechanically replace a “manual” contact, which can be applied to the pelvis of a woman in labor (delivering of a baby), for the purpose of aiding the expulsion of the baby, and also significantly reducing the pain and discomfort associated with this process. The birth ease device mechanically compresses the ilium portion of the pelvis medially and posteriorly, simultaneously. The pressure applied by the birth ease device is under full control of the patient, or a qualified technician, so that the pressure is applied slowly and progressively to a point of maximum comfort, but the pressure can be decreased immediately upon demand by the patient. The duration of the application of compression corresponds with the length of the contraction period for the woman. 
     The birth ease device includes a pair of contact members that are contoured to fit the “ala” of the ilium and are adjustable to fit a range of sizes. The pair of opposed contact members each has an opposed concave surface therein forming a contact volume there between. Each opposed contact member includes a motive mechanism selectively actuated to vary the contact volume between the opposed contact members. A control mechanism is operatively connected to each opposed motive mechanism to selectively increase and decrease the contact volume between the opposed contact members. The motive mechanism is selectively controlled by the woman to increase and decrease the contact volume occupied by the woman&#39;s pelvis, thereby selectively applying and releasing pressure to the woman&#39;s pelvis, and assisting delivery of a child. 
     The birth ease device adds compressive pressure to the “ala” of the ilium. The medial pressure exerted by the birth ease device leverages the pelvis at the sacroiliac joints. This pressure is superior to a line drawn through the sacroiliac joints and causes reduced pressure inferior to this line, mainly affecting the symphysis pubis and the obturator foramen. The pressure applied by the concave, contact members eases the pressure exerted by the emerging head of the baby at the “obturator foramen.” The applied pressure significantly decreases the pain associated with the birth process and aids the efficiency of the baby&#39;s head in forcing the obturator to enlarge. 
     For safety purposes, the pressure applied by the birth ease device is applied slowly, while reduction of the pressure must be immediate and absolute. However, a slow reduction of pressure comparable to the rate of application is sufficient and preferable. The pressure applied has a maximum set point to assure that the patient cannot apply excessive pressure during a time of distress. 
     In a preferred embodiment of the invention, the birth ease device includes a pair of opposed contact members each having an opposed concave surface therein forming a contact volume there between. Each opposed contact member includes a rigid concave back plate member joined at an end to a rigid connector plate member, with each back plate member having an opposed concave surface. Each opposed contact member includes a motive mechanism selectively actuated to vary the contact volume between the opposed contact members. The motive mechanism includes a plurality of inflatable bladder members secured to the opposed concave surface of each back plate member by a flexible padding member secured thereto, with each inflatable bladder member operatively connected to a pressurized fluid source. A control mechanism is operatively connected to each opposed motive mechanism to selectively increase and decrease the contact volume between the opposed contact members. The control mechanism provides selective inflation and deflation of the inflatable bladder members by the pressurized fluid source. The concave surfaces of the flexible padding members of the contact members of the birth ease device are adapted for contact with a woman&#39;s pelvis during child birth. The inflatable bladder members of the motive mechanism are selectively controlled by the woman to increase and decrease the contact volume occupied by the woman&#39;s pelvis, thereby selectively applying and releasing pressure to the woman&#39;s pelvis, and assisting delivery of a child. 
     Referring now to  FIG. 1 , a top view representation of the pelvis of a human is shown. The pelvis is a well-known anatomical structure and will not be discussed in detail. It should be noted that the approximately circular opening in the center of the pelvis is the route through which the head and body of a child passes during natural child birth. 
     Referring now to  FIGS. 2 and 3 , front and rear perspective view of one embodiment of the birth ease device  10  of the present invention are illustrated. The birth ease device  10  includes a pair of padded, concave, opposed contact members  20  that are contoured to fit the “ala” of the ilium of the expectant mother. The pair of opposed contact members  20  each has an opposed concave surface  22  therein. Each opposed contact member  20  includes a rigid concave back plate member  30  joined at an end to the other back plate member  30  via a connector plate member  40 . Each concave back plate member  30  includes a pair of horizontal, rigid ribbing  36  opposite the concave surface  32  of each back plate member  30  for added strength and rigidity. The pair of rigid ribbing  36  also provides a means of securing each back plate member  30  to the connector plate member  40 . For example, the connector plate member  40  is sized to fit between the pair of rigid ribbing  36  of each back plate member  30 . The rigid ribbing  36  includes pairs of vertically aligned apertures  38  adjacent one end of each connector plate member  40 . Each end of the connector plate member  40  includes pairs of hollow cylinders  42  spaced to align with adjacent pairs of aligned apertures  38  in the rigid ribbing  36 . Fasteners  44 , such as rods, pins or bolts, inserted through adjacent pairs of aligned apertures  38  and the pair of hollow cylinders  42  provide rigid connection between each back plate member  30  and the connector plate member  40 . The plurality of pairs of aligned apertures  38  of the rigid ribbing  36  provide for size adjustment between the opposed contact members  20  to accommodate a wide range of individually sized expectant mothers. 
     Referring now to  FIG. 4 , a partially exploded, front perspective view of the birth ease device  10  is shown. A motive mechanism  50  is attached to the concave surface  32  of each opposed back plate member  30 . The motive mechanism  50  is selectively actuated to cause at least one opposed contact member  20  to vary the contact volume V between the two contact members  20 . The motive mechanism  50  includes a plurality of inflatable bladder members  55  secured to the opposed concave surface  32  of each back plate member  30  by a flexible padding member  60  covering the bladder members  55  and secured to each back plate member  30 . Preferably, the plurality of inflatable bladder members  55  of each opposed contact member  20  are vertically aligned on each rigid concave back plate member  30 , as shown in  FIG. 4 . Each inflatable bladder member  55  is operatively connected to a pressurized fluid source, such as a reservoir or compressor  75 , via a fluid conduit system  65  with a control mechanism  80  providing selective inflation and deflation of the inflatable bladder members  55 . 
     Details of the motive mechanism  50 , pressurized fluid source  75  and control mechanism  80  are shown in  FIG. 7 . In this embodiment of the invention, the pressurized fluid source  75  comprises a compressor. The compressed fluid, in this embodiment air, is delivered to the bladder members  55  via the fluid conduit system  65  fitted with pressure regulators  87  and a master control valve  85 . Preferably, the fluid conduit system  65  is individually connected to each bladder member  55  via a separate control valve member  70 . Each control valve member  70  is individually operated by a logic circuit  90  in communication with each control valve member  70 . The logic circuit  90  is operated through communications from a remote control member  95 . The operation of the birth ease device  10  is achieved through a hand-held control member  95  connected to the motive mechanism  50  by a conductor cord  98 . Alternatively, the hand-held control member  95  is a wireless transmitter that communicates with the control motive mechanism  50  by radio or infra-red frequencies. 
     The birth ease device  10  is applied to the pelvis P of a woman in labor for the purpose of aiding the movement of the baby through the birth canal. As illustrated in  FIGS. 5 and 6 , the opposed, concave contact members  20  are positioned about the pelvis of an individual so as to contact and add compressive pressure to the “ala” of the ilium of the woman. The medial pressure exerted by the birth ease device  10  leverages the pelvis P at the sacroiliac joints. This pressure is superior to a line drawn through the sacroiliac joints and causes reduced pressure inferior to this line, mainly affecting the symphysis pubis and the obturator foramen. The pressure applied by the inflatable bladder members  55 , via the flexible padding members  60 , eases the pressure exerted by the emerging head of the baby at the “obturator foramen.” The applied pressure significantly decreases the pain associated with the birth process and aids the efficiency of the baby&#39;s head in forcing the obturator to enlarge. 
     As mentioned above, the operation of the birth ease device  10  positioned about the pelvis P of an individual so as to contact and add compressive pressure to the “ala” of the ilium of the expectant mother, is controlled by that individual. Upon activated by that individual, the logic circuit  90  inflates the bladder members  55  sequentially from the open end of each opposed contact member  20  to the anchored end thereof. This sequence of inflation provides the desired compressive pressure described above. Because the operation of the birth ease device  10  is under the control of the expectant mother, direct and immediate feed back from that individual to the birth ease device  10  occurs. In addition, a safety button is provided on the remote control member  95  that immediately deflates the bladder members  55 , should the expectant mother so choose. 
     While the invention has been particularly shown and described with reference to preferred embodiments thereof, it will be understood by those skilled in the art that various changes in form and details may be made therein without departing from the spirit and scope of the invention.