Abstract:
An automated fundal massager for massaging the uterus in a patient, the apparatus comprising at least one attachment mechanism securing the massager to the patient, a body housing the massager and at least one massager pressingly engaging the fundus having at least one power supply, at least one fundus engagement device, at least one fundus engagement device cover, and at least one system controller in communication with the fundus engagement device, whereby a massager is placed on the patient to engage the fundus of the uterus through massage postpartum to maintain uterine contractility thereby managing postpartum bleeding.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application claims priority of provisional Patent Application No. 62/346,346 filed Jun. 6, 2016. 
     
    
     FIELD OF THE INVENTION 
       [0002]    The invention generally relates to an apparatus that is placed on the lower part of a birth mother&#39;s abdomen following the birth to provide direct pressure to massage the fundus of the uterus (top portion of uterus). In particular, the invention relates to an apparatus for massaging the fundus of the uterus to maintain uterine contractility to prevent excessive postpartum bleeding and hemorrhage and allow a nurse that would normally perform this function to be free to attend to other critical tasks. 
       BACKGROUND 
       [0003]    According to the World Health Organization (2012), postpartum hemorrhage (PPH) is the leading cause of maternal mortality worldwide with a prevalence of approximately 6%. The most common cause of PPH is uterine atony or uterine flaccidity. Active management of the third stage of labor or the period immediately following the birth of the baby to delivery of placenta and the immediate postpartum period by a skilled attendant such as a nurse is vital to help decrease mortality and morbidity of the mother. The World Health Organization (2012) stated that health systems face enormous constraints that hinder the delivery of immediate and emergent obstetrical care, which is vital to saving the lives of women who develop PPH. 
         [0004]    A nurse or skilled attendant present at the birth is required to assess and actively manage maternal bleeding and fundal or uterine firmness using fundal massage in the immediate postpartum period following the birth of a fetus. Uterine contractility or firmness of the uterus is vital to help control and maintain uterine bleeding. Fundal massage is the initial, most effective, noninvasive action used to attain and maintain uterine contractility and firmness. The nurse or skilled attendant has a standard of practice that mandates they perform a manual fundal massage using the fingertips of one or both hands at the lower half of the abdomen on the fundus or top of the descending uterus using circular motions in order initiate and maintain uterine contractility. Fundal massage immediately after birth is often dependent upon bleeding and the firmness of the uterus. If the uterus maintains a soften state or readily softens, the nurse is required to continually perform fundal massage to keep the fundus firm. Frequently, the bedside nurse is pulled away to attend to other urgent or emergent needs such as assisting in resuscitation of the newborn leaving the mother at risk for developing a PPH. 
       SUMMARY OF THE INVENTION 
       [0005]    The present invention overcomes these shortcomings by providing an automated fundal massager that is placed and secured to the birth mother&#39;s body with the massager side down, engaging the abdomen at the fundal point, just below the umbilicus to apply direct pressure and massage the top of the uterus or fundus after birth thereby initiating and maintaining uterine contractility and fundal firmness thus preventing excessive postpartum bleeding and potential PPH. The apparatus may consist of a attachment method for securing the fundal massager to the body in the desired location, a massager to engage the fundus and system controls that determine the level of the massage. The automated fundal massager allows the birth mother to receive the treatment immediately after birth to prevent excessive postpartum bleeding and potential PPH while freeing medical personnel to perform other critical duties. 
         [0006]    There have thus been outlined, rather broadly, the more important features of the invention in order that the detailed description thereof that follows may be better understood, and in order that the present contribution to the art may be better appreciated. There are, of course, additional features of the invention that will be described hereinafter and which will form the subject matter of the claims appended hereto. 
         [0007]    In this respect, before explaining at least one embodiment of the invention in detail, it is to be understood that the invention is not limited in this application to the details of construction and to the arrangements of the components set forth in the following description or illustrated in the drawings. The invention is capable of other embodiments and of being practiced and carried out in various ways. Also, it is to be understood that the phraseology and terminology employed herein are for the purpose of description and should not be regarded as limiting. As such, those skilled in the art will appreciate that the conception, upon which this disclosure is based, may readily be utilized as a basis for the designing of other structures, methods and systems for carrying out the several purposes of the present invention. Additional benefits and advantages of the present invention will become apparent to those skilled in the art to which the present invention relates from the subsequent description of the preferred embodiment and the appended claims, taken in conjunction with the accompanying drawings. It is important, therefore, that the claims be regarded as including such equivalent constructions insofar as they do not depart from the spirit and scope of the present invention, 
         [0008]    Further, the purpose of the foregoing abstract is to enable the U.S. Patent and Trademark Office and the public generally, and especially the scientist, engineers and practitioners in the art who are not familiar with patent or legal terms or phraseology, to determine quickly from a cursory inspection the nature and essence of the technical disclosure of the application. The abstract is neither intended to define the invention of the application, which is measured by the claims, nor is it intended to be limiting as to the scope of the invention in any way. 
     
    
     
       DESCRIPTION OF THE DRAWINGS 
         [0009]      FIG. 1  is a pictorial drawing of the fundal massager attached to a birth mother. 
           [0010]      FIG. 2  is front view of the fundal massager. 
           [0011]      FIG. 3  is a rear view of a fundal massager. 
           [0012]      FIG. 4  is top view of a fundal massager, 
           [0013]      FIG. 5  is top view of a fundal massager with a pneumatic pressure applicator. 
           [0014]      FIG. 6  is a view of a charging station for multiple fundal massagers. 
           [0015]      FIG. 7  is a view of a storage/carrying case for the fundal massager. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0016]      FIG. 1  is a illustrative view  100  that shows the fundal massager  104  attached to a birth mother  102  using housing  106  to secure the fundal massager  104  in the desired location. The fundal massager  104  is placed on the abdomen above the fundus of the uterus and the straps  106  are tightened sufficiently to prevent the movement of the fundal massager  104  while not injuring the birth mother  102 . Nurses or other medical personnel may check the positioning and securing of the fundal massager  104  so that the fundal massager  104  will provide direct pressure to the fundus of the uterus thereby controlling excessive bleeding or postpartum hemorrhaging. The positioning of the fundal massager  104  may be based on each individual birth mother&#39;s  102  anatomy. 
         [0017]    A single strap  106  or multiple straps may be used to secure the fundal massager  104  to the birth mother  102 . In the preferred embodiment, a single strap  106  may be used with one end of the strap  106  entering one side of the fundal massager  104  through the strap attachment point  204  and folded back on to itself and secured by a fastener which may be selected from the following, including but not limited to, snaps, buckle, ratchets, quick-connects, friction, snaps, hooks, and hooks and loops. The remainder of the of the strap  106  may be placed behind the birth mother  102  around her back then the other end on the strap  106  may enter the other side of the fundal massager  104  through the strap attachment point  204  and secured in the same fashion as described above. Before securing the strap  106  in place, the strap  106  is tightened sufficiently securing the strap  106  in place thereby maintaining the placement of the fundal massager  104 . In the preferred embodiment, hooks and loops are the preferred method of securing and fastening the strap  106  to the birth mother  102 . Other embodiments, may include but are not limited, to these below described embodiments, one side of the strap  106  being permanently affixed to the fundal massager  104  at the strap attachment point  204 , the straps  106  ends coming through the strap attachment points  204  and fastening to each other on the top of the fundal massager  104 . Also, the strap  106  that is used for the fetal monitor may be used to secure the fundal massager  104 . 
         [0018]    The straps  106  may be flexible or non-flexible. A non-flexible strap  106  may be desired for birth mothers  102  that need a deep and firm massage of the fundus to prevent the bleeding or PPH and the birth mother  102  can tolerate the additional discomfort due to the inflexibility whereas a flexible strap  106  may be desired for birth mothers  102  that have a lower tolerance of discomfort and the need for a deep massage may be lessened. The straps  106  may be constructed from materials known to one skilled in the art that would be appropriate for use in medical facilities. Additionally, different widths of straps  106  may be used to accommodate different size of birth mothers  102 . A wider strap  106  for a larger mother may help in maintaining the desired position and prevent the fundal massager  104  from flipping while it is in operation due to the birth mother  102  size. The straps  106  attachment to the fundal massager  104  are further illustrated in  FIG. 4 . 
         [0019]      FIG. 2  is a front view  200  of the fundal massager  104 . This view  200  of the fundal massager  104  shows a housing cover  202 , strap attachment points  204 , a power control  206 , a speed control  208 , a mode control  210 , and a frequency control  212 . The housing cover  202  covers and protects the fundal massager&#39;s  104  internal components described later from the harsh environment of a delivery room and prevents contamination. The housing cover  202  may be constructed from materials suitable for a medical facility environment and should be cleanable and sanitizeable. Additionally, the housing cover  202  may contain a seal, such that when the housing cover  202  and housing body  302  are attached so that no material may enter the fundal massager  104 , more specifically, no liquid material such as blood may enter so to prevent person to person contamination. The strap attachment points  204  allow the strap or straps  106  to be attached to the fundal massager  104  and secured around the birth mother&#39;s  102  body and placed in the desired position as described above. 
         [0020]    The power control  206  turns the fundal massager  104  on and off. In the preferred embodiment, the power control  206  may be a push button switch to easily turn on the fundal massager  104  but also may be selected from other switches known to one skilled in the art, including but not limited to, slide switches and rotary switches. The speed control  208  may be used to select the speed at which massager roller  308  articulates to massage the fundus. In a preferred embodiment, the speed control  208  is a slide switch where the left most position provides no movement and as the slide is positioned further to the right from the left most starting point the speed increases proportionally. Other types of speed control devices known to one skilled in the art may be used to control and set the speed, including but not limited to a rotary switch. Additionally, the speed control  208  may also use discreet speed settings instead of the proportional setting of a slide switch where the medical personnel may select a specific setting based on the contractility of the fundus. In addition to the power control  206  and the speed control  208 , the system may also have a mode control  210  that allows the medical personnel to select differing modes based on the type of fundal massage required for a specific birth mother  102 . The different modes may include but are not limited to a continuous mode, a ramping mode, and a pulse mode. In the continuous mode, medical personnel may set the different controls to the desired settings and start the fundal massager  104  and the fundal massager  104  would continue massaging until the medical personnel stopped the fundal massager  104 . In the ramping mode, medical personnel may set the controls specifically the speed control  208  to the desired maximum level, and start the fundal massager  104 . The fundal massager  104  would start at the lowest speed and may increase the speed up to the maximum speed set over a specific desired time then stop and start again at the lowest speed and continue the process of ramping the speed until medical personal stop the fundal massager  104 . The pulse mode allows fundal massager  104  to periodically turn on and provide the massaging action to the fundus at the desired speed and interval then turn off. The frequency control  212  may be used to control how often the massager may turn on and turn off during a specific period of time. This mode may allow the birth mother  102  some period of rest between the massage events. 
         [0021]      FIG. 3  is a rear view  300  of a fundal massager  104 . This view  300  illustrates a fundal massager  104  that may consist of a body housing  302 , a roller cover  304 , a cover attachment  306  and strap attachment points  204 . Inside the body housing  302 , the fundal massager  104  may further consist of a motor  310 , a system controller  314 , a power supply  316 , a power connection  318 , and a battery  320 . In the preferred embodiment, the body housing  302  and the housing cover  202  are fashioned in a trapezoid design to better accommodate the birth mother&#39;s  102  abdominal area but other shapes may be used by one skilled in the art. 
         [0022]    In the preferred embodiment, the roller  308  may be affixed to the motor  310  wherein the motor  310  may move the roller  308  within the defined space of the roller area  312  to provide a massage to the fundus similar to that of a nurse or other medical personnel after the delivery. The roller cover  304  is attached to the body housing  302  via a cover attachment  306 . In the preferred embodiment, the roller cover  304  is semi-permanently affixed to the body housing  302  by physically stitching or other methods known to one skilled in the art for adhering the roller cover  304  to the body housing  302 . In another embodiment, the roller cover  304  may be removably attached to the body housing  302  by hooks and loops or other fastening methods for making the material removable known to one skilled in the art. The roller cover  304  may be selected from silicone, pleather or other material suitable for medical use. The roller  308  that is affixed to the motor  310  may be controlled by the system controller  314  to implement the type of massage selected by the medical personnel. 
         [0023]    The system controller  314  and the motor  310  maybe supplied power by a power supply  316 . The power supply  316  may consist of a power connection  318 , a battery  320 , a battery cover  322 , and power conversion. The power connection  318 , may supply either 120 volts AC, 220 volts AC or DC voltage direct current to the fundal massager  104 . In the preferred embodiment, the motor  310  and system controller  314  operate on DC. In addition to the external power supplied, an internal battery  320  may be used to power the motor  310  and system controller  314  through the power supply  316 . The battery  320  may be removable and replaced through a battery cover  322  or it may be rechargeable either through a charging station described in  FIG. 6  or through power connection  318  and the power supply  316 . The power supply  316  provides power to the system controller  314  and the motor  310  through a power control switch  206 . 
         [0024]    The system controller  314  may take inputs from the controls described in  FIG. 2  such as a power control  206 , a speed control  208 , a mode control  210  and a frequency control  212 . From these inputs, the system controller  314  may manipulate the motor  310  and roller  308  to perform the desired massage to the fundus. The preferred embodiment uses analogue controls to select the massaging technique desired by the medical personnel. In another embodiment, these analog controls may be replaced with digital controls to perform the same functions. Additionally, a microcontroller, programmable logic unit or other programmable unit may be used to perform the function of the system controller  314  and analog inputs. The system controller  314  may be controlled remotely by wired and wireless communication. 
         [0025]      FIG. 4  is a top view  400  of a fundal massager  104 . This view of the fundal massager  104  shows a roller cushion  402  that covers the roller  308 , straps  106 , the body housing  302 , the roller cover  304 . This view further illustrates the roller  308  protruding from the body housing  302  and connected to the motor  310 . This view also shows that the roller  308  resides under the roller cover  304 , wherein the roller  308 , through the motor  310 , moves around inside the covering, providing the massage. The roller cushion  402  may provide some cushioning between the roller  308  and the birthing mother to prevent bruising during operation. The cushion may be affixed to the roller  308  or the roller cover  304 . 
         [0026]      FIG. 5  is a top view of a fundal massager  104  with a pneumatic pressure applicator  500 . The pneumatic pressure applicator  500  may consist of a pneumatic housing  502 , a pneumatic bladder  504 , a pump control  508  and a pump release  510 . The fundal massager  104  is designed to provide a deep massage of the fundus of the uterine to help control and prevent bleeding and possibly aver PPH. The straps  106  may be tightened, which secures the fundal massager  104  to the birthmother&#39;s body to hold the fundal massager  104  in the desired position and to provide pressure to be fundus of the uterus. Additionally, some birth mothers  102  may need additional pressure applied to the fundus of the uterus to prevent bleeding and PPH. To increase the pressure, a pneumatic pressure applicator  500  may be placed on the back of the fundal massager  104  or may be an integral part of the fundal massager  104 . When air is pumped into the pneumatic bladder  504  via the pump control  508 , the expanded pneumatic bladder  506  may provide additional pressure to the fundus of the uterus. Once the massaging has been completed, then medical personnel may press the pump release  510  to release the pressure to allow the fundal massager  104  to be more easily removed from the birthing mother. The amount of pumping by pump control  508  may determine the additional of pressure applied to fundus. 
         [0027]      FIG. 6  is a view of a charging station  600  for multiple fundal massagers  104 . The charging station  600  may consist of a battery charger  602 , a massager power connection  604  and a charging power connection  606 . This view illustrates three fundal massagers  104  charging in a five-slot charging station  600 . The charging station  600  in the current embodiment allows for up to five fundal massagers  104  to be charged simultaneously. The number of fundal massagers  104  being charged could be increased or decreased based on the requirements of the medical facility. For example, hospitals that only do a few deliveries may want a smaller charging station but other hospitals that have much larger birthing centers may want multiple charging stations  600  or a single charging station  600  with multiple positions for multiple fundal massagers  104 . In the preferred embodiment, the power connection  606  is connected to a standard wall socket that provides 120 volts AC. This power is then supplied to the battery charger  602  within the charging station  600 . This charging power is then supplied to the fundal massagers  104  by the massager power connection  604  thus charging the internal battery  320 . This power is then supplied to the fundal massager  104  to charge the battery  320 . Upon completing the charging of the fundal massager  104  the charging station  600  may provide some type of indication to the medical personnel when a fundal massager  104  is fully charged. Additionally, the charging station  600  may provide indication that a specific fundal massager  104  is charging. 
         [0028]      FIG. 7  is a view of a storage/carrying case  700  for the fundal massager  104 . This view illustrates a container  702  with a fundal massager  104  inside with the lid  704  in the closed position. The case  700  may consist of a container  702 , a lid  704 , a hinge  706 , positioners  708 , a lock  710 , and handle  712 . The container  702  may have positioners  708  in each corner to suspend the fundal massager  104 . The fundal massager  104  is placed massager side down where such the positioner  708  engages the corners and suspends the fundal massager  104  such that the roller  308  and the roller cover  304  do not touch the bottom of the storage case  702 . A pad may be placed inside the lid  704  to provide pressure to the fundal massager  104  to maintain the fundal massager  104 &#39;s position while it is being stored or transported. Additional padding may be added to prevent the fundal massager  104  from being damaged while in storage and during transport. Another embodiment allows a strap inside the container  702  to secure the fundal massager  104  in place. The strap may use hooks and loops or other known securing methods known to one skilled in the art to secure the fundal massager  104 . 
         [0029]    In the preferred embodiment, the lid  704  is hingedly attached by a hinge  706  to the container  702  allowing all the parts of the fundal massager case  700  to remain together. Other embodiments may allow the lid  704  to separate from the container  702  or the lid  704  may be attached to the container  702  by straps. Additionally, the lid  704  may be secured in place by a lock  710  or by other means known by one skilled in the art including but not limited to straps with hooks and loops. 
         [0030]    In this preferred embodiment, the ease  700  may only carry a single fundal massager  104 . Other embodiments may be designed to transport multiple fundal massagers  104  in a single case  700 . Additionally, the case  700  may be designed such that the fundal massager  104  may be charged while it is inside the case  700 .