Abstract:
A uterine contractile device includes a series of perforated tubes, a sealing balloon, and an additional connecting tube to deliver a vacuum force inside the lumen of a postpartum uterus. The uterine contractile device may be used after child birth to facilitate contraction of a woman&#39;s uterus. By facilitating contraction of the uterus, a medical professional may achieve immediate and sustained hemostasis of the mother.

Description:
BACKGROUND 
       [0001]    Postpartum hemorrhage, defined as excessive blood loss after birth, is the leading cause of maternal death in the world, claiming the lives of over 125,000 mothers every year. Inability to control postpartum bleeding can require a woman to receive multiple blood transfusions, and in severe cases, a full hysterectomy. Accordingly, it is desirable to control such postpartum bleeding, if possible, at its onset. The cause of postpartum hemorrhage, in approximately 80% of cases, is uterine atony, which is the inability of the woman&#39;s uterus to contract after delivering the child. Risk factors for uterine atony include prolonged staged of labor, preeclampsia, and multiparity. 
         [0002]    The original technology for treating postpartum hemorrhage was oxytoxic agents, hormonal agents that induce muscle contraction. Unfortunately, studies have increasingly shown that oxytoxic agents do not significantly reduce either the incidence of postpartum hemorrhage or the amount of blood lost. Some studies have even indicated that oxytoxic agents are being over used to the point that this treatment increases the risk of uterine atony. 
         [0003]    Other approaches have been taken, such as medical devices. U.S. Pat. No. 4,552,557 discloses a inflatable intrauterine device that inflates intrauterinely, acting a tamponade to stop blood flow. Because this device expands when inflated, this device and method do not facilitate uterine contraction. U.S. Patent Publication No. 2011/0087337 discloses a generic organ contraction device for controlling the flow of fluid in a lumen formed by a tissue wall of a patient&#39;s organ, however this device does not use suction to contract the organ. Finally, U.S. Patent Publication No. 2011/0172569 discloses a surgical vacuum device that uses a suction cup to tamponade specific surfaces of an organ. However, the suction cup is not capable of contracting a uterus. 
         [0004]    Dr. Christopher B. Lynch has developed a technique for surgically removing the uterus, wrapping the uterus in sutures, and pulling on these sutures to contract the uterus. Although this approach has been effective at arresting postpartum hemorrhage this method is extremely invasive and potentially very harmful to the patient. What is needed is a device that can contract a postpartum uterus in a non-invasive manner. 
       SUMMARY OF THE INVENTION 
       [0005]    The present invention provides a transvaginally-delivered uterine contractile device that provides a vacuum to the uterus which stops hemorrhaging, removes blood from the uterus and causes the uterus to contract. In an embodiment, the uterine contractile device comprises a plurality of porous, flexible medical-grade tubes that allow for delivery of the vacuum to the uterine lumen. Additionally, the uterine contractile device seals the uterus off from atmospheric pressure using an occlusion balloon that engages the inner surface of the distal end of the vaginal canal. Once inserted into the uterus, the occlusion balloon can be inflated to create a seal with the vaginal canal. The device may then be connected to a medical-grade pump with a tissue and blood filter. The pump can apply a vacuum to the device which removes fluids from the uterus and causes the uterus to contact around the device. 
         [0006]    By contracting a woman&#39;s postpartum uterus with the inventive device, a medical professional can immediately stop hemorrhaging and blood loss from the uterus after child birth. This reduces a wide range of risks to mother while in the hospital, including the need for blood transfusions or hysterectomy. Furthermore, because the device is delivered transvaginally, the mother can remain conscious during the procedure. Medical professionals can also leave the device in the patient with minimal monitoring necessary. The use of a vacuum furthermore provides a uniform mechanical stimulus to the walls of the postpartum uterus, facilitating an even contractile movement of the tissue. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0007]      FIG. 1  is a perspective view of an embodiment of the uterine contractile device; 
           [0008]      FIG. 2  is a cross sectional view of and embodiment of the perforated tubing portion of the uterine contractile device; 
           [0009]      FIGS. 3 and 4  are cross sectional views of different embodiments of the perforated tubes to the connecting tube connection portion of the uterine contractile device; 
           [0010]      FIG. 5  is a side cross sectional view of an embodiment of the connecting tube and surrounding occlusion sealing balloon; 
           [0011]      FIG. 6  is a cross sectional view of an embodiment of the connecting tube of the uterine contractile device having a smaller lumen for the delivery of a fluid to the occlusion sealing balloon; 
           [0012]      FIG. 7  is a top view of an alternative embodiment of the uterine contractile device that includes a mechanism for delivering fluid to the occlusion sealing balloon; 
           [0013]      FIG. 8  is a perspective view of an embodiment of the uterine contractile device wherein the perforated tubing is configured as elongated members rather than a loop extending from the connecting tube; 
           [0014]      FIG. 9  is a perspective view of an embodiment of the uterine contractile device having perforated tubing in both elongated member and loop configurations; and 
           [0015]      FIGS. 10-12  are cross sectional side views of a uterus with the uterine contractile device. 
       
    
    
     DETAILED DESCRIPTION 
       [0016]    A first embodiment of the uterine contractile device is illustrated in  FIG. 1 . In this embodiment, the uterine contractile device has a plurality of curved tubes  10 ,  12  that attach to the base  14  of a larger connecting tube  16 . This connecting tube  16  passes through a sealing balloon  18 . In this embodiment of the device, the sealing balloon  18  is inflated via a channel  20  inside the connecting tube by some external fluid source via an attached fluid tube  22 . In an embodiment, a compressible gas such as nitrogen or air can be used to inflate the sealing balloon  18 . Alternatively, in other embodiments, any other fluid source or mechanism can be used to inflate the sealing balloon  18 . The uterine contractile device is intended to be partially placed within a woman&#39;s body with the curved tubes  10 ,  12  inside the woman&#39;s atonic uterus, while the connecting tube  16  and surrounding occlusion balloon are oriented inside the vagina. 
         [0017]    In the embodiment illustrated in  FIG. 1 , the uterine contractile device contains two tubes  10 ,  12  that are both arranged in loops that extend different distances. The outer tube  10  can have a larger length and extend in a wider loop away from the device and the inner tube  12  can have a shorter length and be configured in a loop that is within the wider loop of the outer tube  10 . The tubes  10 ,  12  may be of the same or differing cross section diameters. In a preferred embodiment, the outer diameters of the tubes  10 ,  12  may be as small as 25 mm and as large as 125 mm. The number of tubes may exceed two, but in a preferred embodiment, there should be no more than eight tubes extending from the uterine contractile device. The outer cross sectional shape of the tubes  10 ,  12  should be substantially rounded to prevent abrasion and allow for greater acceptance by the native tissue. 
         [0018]    The tubes  10 ,  12  can be composed of a flexible material that allows the tubes  10 ,  12  to be bent in any direction which also allows the tubes  10 ,  12  to conform as necessary to any woman&#39;s anatomy. However, the tube  10 ,  12  material and construction also preferably provide sufficient rigidity to maintain a fixed angle with the connecting tube  16 . The tubes  10 ,  12  are preferably composed of a material appropriate for medical applications, including but not limited to: rubber, plastic, silicone, silastic, polyethylene, polyurethane, other plastic(s) or metal(s) or any other suitable materials. These materials can be used alone or in combination with each other. In an embodiment, the curved perforated tubes  10 ,  12  may be made of an elastic material having a Shore A hardness of about 60-80 and the connecting tube  16  may have a Shore A hardness of about 70-90. 
         [0019]    A cross sectional view of a perforated portion of the tube  10  is illustrated in  FIG. 2 . Each tube  10  has in interior space that can be connected to a plurality of perforations. When a vacuum is applied to the interior of the tube, the vacuum can cause fluids including blood, water and other fluids to flow from the interior of the woman&#39;s uterus adjacent the exterior of the tube  10  through the perforations and into the interior volume of the tube  10 . The vacuum can also cause the uterus to contract around the tube  10 . 
         [0020]    The perforations  40  in the tube  10  can be round holes with rounded exterior edges that may be formed in one or more sides of the tubing. However, it is preferable that these perforations  40  be on the medial sides of the tubing  10 , reducing their direct contact with tissue. The interior edge  42  of the perforation  40 , in addition the shape for the perforation  40 , can be substantially rounded, to allow for better interaction with tissue. These rounded edges provide a safety feature for the device. For example, if the edge of the perforation  40  was a sharp edge, the vacuum might suck the interior of the uterus against the sharp edge of the perforation  40  damaging the uterus. In an embodiment, the perforations may have a diameter between about 0.1-0.6 cm. The inner diameter of the tube  10  can be between about 0.25-1.00 cm and the outer diameter of the tube  10  can be between about 0.50 to 1.25 cm. 
         [0021]    A top view of an embodiment of an attachment structure for connecting the tubes to the end of the connecting tube  16  is illustrated in  FIG. 3 . Ideally, the attachment structure is a single piece structure. However in other embodiments, other devices and methods for tube attachment are possible. In  FIG. 3 , the tubing attachments are offset from each other, allowing the larger attachments  50  and  52  to fit next to the smaller attachments  54  and  56 .  FIG. 4  illustrates an alternate structure for attachment of the tubes to the end of the connecting tube  16 , wherein the outer, larger tube attachments  60  and  62  are directly in line with the inner, smaller tube attachments  64  and  66 , and the cross section of the entire attachment is more elliptical than circular. 
         [0022]      FIG. 5  illustrates a side cross sectional view of an embodiment of the sealing balloon  72  that surrounds the connecting tube  16 . A channel  70  can be used to deliver a sterile fluid such as saline to the lumen of the balloon  72  at opening  74 . In other embodiments, any other type of sterile fluid or compressible gas can be used to inflate the balloon  72 . The total inflated volume should be substantially large enough to fill the entire cross section of the entrance of the woman&#39;s postpartum uterus, which can be 300-400 milliliters or more. The length of the balloon  72  may be between 5.0 and 10.0 cm in length. The outer diameter of the connecting tube  16  can be between about 1.5-3.0 cm. The inner diameter of the connecting tube  16  which is the suction lumen can be between about 1.2-2.7 cm and the inner diameter of the channel  70  which is the balloon inflation lumen can be between about 0.2-0.4 cm and the outer diameter of the channel  70  can be between about 0.25-0.50. As discussed, the material of the connecting tube  16  may be composed of rubber, plastic, silicone, silastic, plastic, polyethylene, and polyurethane or any other suitable material. The preferred material is silicone. 
         [0023]      FIG. 6  illustrates a cross sectional view of an embodiment of the connecting tube  16 . The larger lumen  70  delivers the vacuum of the device. The smaller lumen  72  delivers the sterile fluid such as saline the sealing balloon.  FIG. 7  illustrates a top view of an alternate method of inflating the sealing balloon. The external tube  80  delivers the sterile fluid to the sealing balloon  82  through a sealed opening in the balloon  84 . 
         [0024]    The material of the connecting tube may be composed of rubber, plastic, silicone, silastic, plastic, polyethylene, polyurethane, and one or more metals or any other suitable material or combination of materials. The preferred material is silicone. 
         [0025]      FIG. 8  illustrates an alternate embodiment of the device (perspective view). In this embodiment, the array of tubes  90 ,  92 ,  94 , and  96  do not bend around to the point of attachment  98  of the connecting tube  100 . Preferably, there should be no more than sixteen tubes in the array. The tips of these tubes should be substantially rounded and the exterior surfaces of the tubes  90 ,  92 ,  94 , and  96  should not have any sharp edges to prevent injury to the patient and allow for better interaction with tissue. 
         [0026]      FIG. 9  illustrates another alternate embodiment of the device (perspective view). In this embodiment, the array of tubes  102 ,  104 , and  106  are a combination of previously described embodiments. The device may include one or more tubes in a loop configuration that have tubes that are coupled to two points and one or more tubes that extend from the connection tube  110  from a single connection point. All make an attachment  108  at the connecting tube  110 . In an embodiment, the distance from a distal end of the tube  106  to the connecting tube  110  can be about 8.0-15.0 cm and the width of the connecting tube  110  in an uncompressed position can be about 4.0-9.0 cm. The length of the connecting tube  110  can be about 8.0-15.0 cm. 
       Operation of the Device 
       [0027]      FIGS. 10-11  illustrate a sequence of cross sectional side views illustrating the implementation of the device  100  in a patient (side views). In  FIG. 10 , the device  100  is delivered transvaginally to the lumen  114  of the woman&#39;s atonic uterus  116 , and the sealing balloon  118  is inflated near the distal end of the woman&#39;s vagina  120  to create a vacuum seal. In an embodiment, the sealing balloon  118  can be inflated to a pressure that can be about 0.1 to 5 psi. With reference to  FIG. 11 , the connecting tube is coupled to a vacuum mechanism and the vacuum is activated, causing the device  100  to remove fluid from the lumen  114  and causing the woman&#39;s uterus  116  to contract toward the device  100 . Once the device  100  has fully sealed the uterus and suction has been initiated, the uterus may contract in a time from about 1.2 to 15 seconds. However, in other embodiments, a time frame of about 3 to 5 seconds may be more appropriate. A doctor can also monitor the contraction progress through a visual exterior assessment and/or with an ultrasound monitoring device which may be optional. 
         [0028]    The process of contracting the uterine muscle will close exposed uterine arterioles in the uterine wall. In  FIG. 11 , the postpartum uterus  126  has been successfully contracted around the perforated tubing  128 . The sealing balloon  130  may remain inflated as long as deemed necessary to maintain the uterine contraction. The device may be removed once a medical professional has determined that the mother&#39;s uterine muscles have recovered from their original fatigue. The process for removing the device  100  can comprise: clamping the suction tube  140  with a clamp mechanism  152  to seal the pathway and prevent gas or fluids from flowing back into the device  100  and uterus  126 . The doctor(s) can then discontinue the suction being applied to the device  100 . By maintaining the airtight seal in the uterus, the pressure differential is maintained, dramatically decreasing the possibility of the uterus returning to its atonic state. The device  100  should remain in the uterus for a period of at least 60 minutes and should be removed from the patient after no more than 24 hours. In an embodiment, the doctor may want to only remote the device  100  after the patient&#39;s blood pressure and heart rate return to normal levels. For example, the systolic blood pressure may need to be above about 90 mm Hg and below about 140 mm Hg and the heart rate may need to be above about 40 beats per minute and less than about 100 beats per minute. 
         [0029]      FIG. 12  illustrates a schematic of an embodiment of the device connected to external equipment. Air and other matter in the lumen of the postpartum uterus  130  passes through the perforated tubing  134  and  136  into the connecting tube  138 . The vacuumed air then passes through a standard hospital suction line  140  into a standard fluid filter  142 , allowing any collected blood or tissue to be removed from flow. The air finally passes into a standard hospital suction pump  144 . This pump  144  can be operated over a range of flow rates, but preferably will be less than 30 liters per minute. The pressure inside the uterus will gradually drop to about 2 PSI below atmospheric pressure. At this point, the uterus will begin to contact slowly, depending on the flow rate of the pump  144 . 
         [0030]    The present disclosure, in various embodiments, includes components, methods, processes, systems and/or apparatus substantially as depicted and described herein, including various embodiments, subcombinations, and subsets thereof. Those of skill in the art will understand how to make and use the present disclosure after understanding the present disclosure. The present disclosure, in various embodiments, includes providing devices and processes in the absence of items not depicted and/or described herein or in various embodiments hereof, including in the absence of such items as may have been used in previous devices or processes, e.g., for improving performance, achieving ease and/or reducing cost of implementation. Rather, as the flowing claims reflect, inventive aspects lie in less than all features of any single foregoing disclosed embodiment.