WO2014066547A1 - Blood loss monitoring and quantification devices, systems, and methods - Google Patents

Blood loss monitoring and quantification devices, systems, and methods

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Publication number
WO2014066547A1
WO2014066547A1 PCT/US2013/066451 US2013066451W WO2014066547A1 WO 2014066547 A1 WO2014066547 A1 WO 2014066547A1 US 2013066451 W US2013066451 W US 2013066451W WO 2014066547 A1 WO2014066547 A1 WO 2014066547A1
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WO
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Application
Patent type
Prior art keywords
drains
embodiments
angle
device
devices
Prior art date
Application number
PCT/US2013/066451
Other languages
French (fr)
Inventor
Andrew H. SCHEINFELD
Philip R. Carter
Original Assignee
Scheinfeld Andrew H
Carter Philip R
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Detecting, measuring or recording for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150015Source of blood
    • A61B5/150045Source of blood for blood from vagina, placenta, colon or mouth
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Detecting, measuring or recording for diagnostic purposes; Identification of persons
    • A61B5/02Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
    • A61B5/02042Determining blood loss or bleeding, e.g. during a surgical procedure
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Detecting, measuring or recording for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150053Details for enhanced collection of blood or interstitial fluid at the sample site, e.g. by applying compression, heat, vibration, ultrasound, suction or vacuum to tissue; for reduction of pain or discomfort; Skin piercing elements, e.g. blades, needles, lancets or canulas, with adjustable piercing speed
    • A61B5/150061Means for enhancing collection
    • A61B5/150099Means for enhancing collection by negative pressure, other than vacuum extraction into a syringe by pulling on the piston rod or into pre-evacuated tubes

Abstract

The present invention sets forth devices, methods, and systems for collecting and monitoring blood loss through the vagina during a surgical procedure, such as, but not limited to, a Cesarean section procedure. The present invention sets forth devices that quantify the amount of blood that is lost through the vagina and additionally alerts medical personnel when a critical amount of blood has been lost from a patient. The inventions set forth herein provide accurate methods and devices for monitoring blood loss through the vagina from a patient giving birth by way of a Cesarean section procedure. The devices described herein provide life-saving diagnostic capabilities which include, but are not limited to, the identification of a life-threating hemorrhage condition in a patient during a Cesarean section procedure.

Description

BLOOD LOSS MONITORING AND QUANTIFICATION

DEVICES, SYSTEMS, AND METHODS [0001] This application claims priority from U.S. Provisional Patent Application Serial Number 61/717,565, which was filed on 23 October 2012. The entire content of this provisional application is incorporated herein by reference in its entirety for all purposes.

BACKGROUND OF THE INVENTION

[0002] During certain medical procedures, such as a Cesarean section operation, a patient may die or suffer serious morbidity due to blood loss generally as well as blood loss specifically into the vaginal canal. In fact, hemorrhage is one of the leading causes of maternal mortality. In certain metropolitan cities in the United States, for example, the number of maternal deaths among is greater than 12.7 maternal deaths per 100,000 live births. Blood lost through the vagina is often unnoticed by the medical personnel attending to a patient because the operating equipment obstructs the view of the vaginal orifice and the patient's vagina itself conceals large volumes of pooled blood.

[0003] Hospitals and medical educational institutions now encourage doctors and hospital staff to quantify the blood loss during surgical procedures. However, the methods for quantifying blood loss are typically not accurate or practical to use. It is known in the field to which the present invention pertains that the accurate measurement of blood loss is critical for early identification and appropriate management of maternal hemorrhage during both vaginal and cesarean deliveries. However, due to a lack of technology, medical personnel are limited to weighing devices and clothes which contact a patient undergoing surgery, visualizing canisters and drapes which are used during surgery, and making qualitative estimations of blood loss. Research has shown that these aforementioned methods are not accurate and tend to underestimate postpartum blood loss by approximately 33-35%. Visual- based estimations of blood loss are further complicated by the presence of other non-blood entities that end up contacting the blood such as amniotic fluid, cleaning and preparation equipment, irrigants, urine, stool, and lap pads. Also, the materials and methods currently used for estimating blood loss are insufficient for certain procedures such as Cesarean section procedures. [0004] Therefore, there exists a need in the field to which the present invention pertains related to devices and methods for collecting and accurately monitoring blood loss during certain procedures such as, but not limited to, Cesarean section procedures. There is a need related to the collection and monitoring of blood loss into the vagina during Cesarean section procedures. There further exists a need related to a device which can diagnose that a life- threatening volume of blood has been lost from a patient during a Cesarean section procedure through the vagina and which can alert attendant medical personnel accordingly. The present invention provides devices, methods, and systems which address these as well as many other needs in the relevant field. BRIEF SUMMARY OF THE INVENTION

[0005] In one aspect, the present invention provides a biocompatible medical device including a flexible Y-shaped suction tube having three ends and including two rigid and porous drains attached to two of the three ends. The drains are sized and angled to contact the posterior vaginal fornix when vaginally inserted. Further, the angle between the drains increases when a compressive force is not applied to reduce the angle between the drains. Also included is a vacuum collection component. The vacuum collection component is in fluid communication with the end of the tube not directly attached to a drain. The component has means for signaling for the collection of a critical amount of blood. Also, the component is capable of collecting at least 500 mL of fluid. [0006] In a second aspect, the present invention provides a biocompatible medical device including a flexible v-shaped suction tube having three ends and including two rigid and porous drains attached to two of the three ends. One of the three ends includes the vertex of the v-shaped junction in this device. The drains are sized and angled to contact the posterior vaginal fornix when vaginally inserted. The angle between the drains increases when a compressive force is not applied to reduce the angle between the drains. Also included is a vacuum collection component. The component is in fluid communication with the end of the tube not directly attached to a drain. Also, the component has means for signaling for the collection of a critical amount of blood. The component is capable of collecting at least 500 mL of fluid. [0007] In a third aspect, the present invention provides a biocompatible medical device including a flexible suction tube having two ends and including at least one drain attached to one end. The drain is sized to contact the posterior vaginal fornix when vaginally inserted. Also included is a vacuum collection component. The component is in fluid communication with the end of the tube not directly attached to a drain. Also, the component has means for signaling for the collection of a critical amount of blood. The component is capable of collecting at least 500 mL of fluid.

[0008] In a fourth aspect, the present invention provides methods for collecting blood during a Cesarean section procedure using a device, described herein, including applying a compressive force to reduce the angle between the drains of the device; inserting the device intra-vaginally; allowing the angle between the drains to increase until the drains contact the lateral vaginal fornices; and activating a vacuum pump that is in fluid communication with the device.

[0009] In a fifth aspect, the present invention provides methods for collecting blood during a Cesarean section procedure using a device, described herein, including applying a compressive force to reduce the angle between the drains of the device; inserting the device inter-vaginally allowing the angle between the drains to increase until the drains contact the lateral vaginal fornices; and activating a vacuum pump that is in fluid communication with the device.

[0010] In a sixth aspect, the present invention provides a method for signaling that a critical amount of blood has been lost from a patient during a Cesarean section procedure. The method includes using a device described herein.

[0011] In any of the embodiments described herein, an inflatable or Tillable balloon may be included with the medical device to secure the device once inserted into a vagina or vaginal opening. In some embodiments, the inflatable or Tillable balloon temporarily seals the device to the inner vaginal wall so that fluids cannot leak out of the vaginal opening. BRIEF DESCRIPTION OF THE DRAWINGS

[0012] Figure 1 shows a first embodiment of the present invention.

[0013] Figure 2 shows a first embodiment of the present invention when vaginally inserted.

[0014] Figure 3 shows a second embodiment of the present invention.

[0015] Figure 4 shows a second embodiment of the present invention when vaginally inserted. [0016] Figure 5 shows a third embodiment of the present invention.

[0017] Figure 6 shows a third embodiment of the present invention when vaginally inserted.

[0018] Figure 7 shows an embodiments of the present invention that includes a grill or cage around the drain so that the inner vaginal wall does not collapse and contact the surface of the drain during operation of the device.

[0019] Figure 8 shows an embodiments of the present invention that includes a grill or cage around the drains so that the inner vaginal wall does not collapse and contact the surface of the drains during operation of the device.

DETAILED DESCRIPTION OF THE INVENTION

I. General

[0020] The present invention sets forth various devices, methods, and systems for collecting and monitoring blood loss during a surgical procedure, such as, but not limited to, a Cesarean section procedure. Furthermore, the present invention includes methods and devices for alerting attendant medical personnel when a critical amount of blood has been lost from a patient, such as, but not limited to, a woman giving birth by way of a Cesarean section procedure.

II. Definitions [0021] As used herein, the term "biocompatible" means being compatible with living tissue or a living system. Biocompatible also means not being toxic or injurious and not causing an immunologic rejection.

[0022] As used herein, the term "flexible" means capable of yielding to a force or of being flexed. For example, the Y-shaped and V-shaped devices of the present invention can be flexed about the angle between the drains. This means the angle between the drains can be increased or decreased by forcing the angling between the drains to increase or decrease.

[0023] As used herein, the term "Y-shaped" refers to a structure that has a shape similar to the shape of the letter "Y." A Y-shape structure has three ends and three angles

therebetween, one angle of which is smaller than the other two angles. [0024] As used herein, the term "ml" refers to milliliter. Equivalently, "cc" can be used for "ml."

[0025] As used herein, the phrase "suction tube" refers to a tube, hose, cylinder, or related device that is capable of maintaining fluid communication with a suction or vacuum device. A suction tube may include, but is not limited to, biocompatible tubing.

[0026] As used herein, the term "rigid" refers to a structure that is not flexible, as defined herein.

[0027] As used herein, the term "porous" refers to a structure having pores. As used herein, the term "pores" refers to holes or apertures in a device set forth herein. The pores are large enough to allow blood to flow through them.

[0028] As used herein, the term "drain" refers to a device that is capable of collecting and carrying away of fluids, e.g. blood or amniotic fluids.

[0029] As used herein, the phrase "vaginally inserted" means to be inserted within the vagina or vaginal canal. [0030] As used herein, the phrase "angle between the drains" refers to the smallest angle that is defined by the two drains which are connected to either the Y-shaped or V-shaped suction tube.

[0031] As used herein, the term "increase" means to become greater in size. For example, when the angle between the drains increases, the angle between the drains may increase from 10° to 25 °C.

[0032] As used herein, the phrase "compressive force" refers to a force meant to compress or reduce. For example, a force may be applied so as to reduce the angle between the drains. Such a force is referred to herein as a compressive force.

[0033] As used herein, the phrase "fluid communication" refers to a mechanical or physical connection that provides for the transfer of gas or liquids. For example, when the drains are in fluid communication with the suction tube, any fluid which enters the drains will be transferred to the suction tube. Blood will flow from the drains and into the suction tube if the drains and the suction tube are in fluid communication. [0034] As used herein, the phrase "means for signaling for the collection of a critical amount of blood" refers to structures and devices which may be included with a system or device of the present invention and can alert to attendant medical personnel that a certain amount of blood has been lost from a patient. These means may include a sound or light. These means may include a wireless device worn by an attendant medical person which vibrates or makes a noise when a certain amount of blood has been collected in the device. The means may include a combination of sound and light that is useful for alerting other human beings that a certain amount of blood has been lost from a patient for whom the device is being used. [0035] As used herein, the term "v-shaped" refers to a connection where two sides join together to resemble the shape of the letter "v."

[0036] As used herein, the term "about" refers to a range of numbers that encompasses plus or minus 10 % of the number qualified by the word about. For example, about 45 ° refers to 40.5 °, 45 °, and 49.5 ° as well as all the angles in between these angles. For example, about 10 cm refers to 9 cm, 10 cm, and 1 1 cm as well as the numbers in between such as 9.5 cm and 10.5 cm. For example, about 10 mm refers to 9 mm, 10 mm, and 11 mm as well as the numbers in between such as 9.5 mm and 10.5 mm.

[0037] As used herein, the term "material" refers to the matter or substance from which a device is made of or of which it is composed. For example, the material that the drains may be made of or composed of includes, but is not limited to, a biocompatible material, high density polyethylene, low density polyethylene, poly-lactic acid, poly-carbonate, poly-vinyl chloride, poly-styrene, steel, surgical steel, stainless steel, or Teflon coated materials.

[0038] As used herein, the phrase "collapsing against the suction tube" refers to the condition wherein the tissue from the patient obstructs the flow of fluid through the device. For example, if the vaginal wall collapses against the drains, the vaginal wall may obstruct the flow of blood into the device at the position where the vaginal wall contacts the drain.

[0039] As used herein, the phrase "a critical amount of blood" refers to an amount of blood that when lost from a patient results in a negative or life-threatening medical condition or state in a patient. A critical amount of blood loss may refer to an amount of blood loss that could result in death in the patient from whom the blood was lost. A critical amount of blood, as set forth herein, may include 500 ml, 1000 ml, 1250 ml, 1500 ml, 1750ml, 2000 ml, 2125 ml, 2500 ml, 2725 ml, 3000 ml, 3500 ml, 4000 ml, 4500 ml, 5000 ml, 5500 ml, 6000 ml, 6500 ml, 7000 ml, 7500 ml, or 8000 ml.

[0040] As used herein, the term "applying" refers to, for example, applying a compressive force to reduce the angle between the drains. "Applying" also refers to an active means by which the angle between the drains is manipulated, modulated, altered, augmented, or compressed.

[0041] As used herein, the term "inserting" means to place inside or into or also to introduce inside. For example, a device described herein may be introduced inside the vagina of a woman undergoing a Cesarean section. [0042] As used herein, the term "intra-vaginally" means within or inside the vagina or vaginal canal. For example, a device described herein may be inserted within the vagina of a woman undergoing a Cesarean section.

[0043] As used herein, the term "inflated" refers to the state of being filled or expanded with air, gas, or liquid. For example, an inflated balloon is a balloon that is filled with air or that is expanded because it contains a liquid or a gas.

[0044] As used herein, the term "balloon" refers to any device capable of holding a gas or liquid. The present invention includes balloons and equivalent devices which assist in the formation of a seal with the vagina or the inner wall of the vagina. In some embodiments of the invention, a balloon device is used to keep the device in place. In other embodiments, the balloon device is used to secure the device inside the vagina.

[0045] As used herein, the term "allowing" refers to the act or state of permitting another thing to be. For example, allowing the angle between the drains to increase refers to the act of permitting the angle between the drains to increase according to the tendency of the device to expand when a compressive force is not applied to reduce the angle between the drains. For example allowing the angle between the drains to increase until the drains contact the lateral vaginal fornices.

[0046] As used herein, the phrase "activating a vacuum pump" refers to the steps required to turn a vacuum pump on or to cause a vacuum pump to operate as intended and so as to result in a reduced pressure in the lines of fluid communication with a device described herein. [0047] As used herein, the phrase "patient in need thereof refers to a mammal, person, human, patient, woman, pregnant woman, member of a group of women, or member of a group of pregnant women who benefit by the use of a device or method of the present invention. For example, a patient in need thereof may include, but is not limited to, a pregnant woman who is giving birth and undergoing a Cesarean section procedure.

III. Devices& Systems

[0048] Figure 1 shows one embodiment of a device encompassed by the present invention. Figure 1 shows a y-shaped device. The top of Figure 1 shows a device when a compressive force is applied to reduce the angle between the drain. In Figure 1, the suction tube is y- shaped. Two drains are each individually attached to the two ends of the y-shaped suction tube that form the smallest possible angle therebetween. The drains in Figure 1 are porous and cylindrical. The approximate diameter of the cylindrical drains is 1 cm. The approximate length of the porous portion of the drains is 9 cm. The approximate distance from the end of the drains to the vertex of the y-shaped suction tube is 11.5 cm. The bottom of figure 1 shows the device when the aforementioned compressive force is not applied to reduce the angle between the drains. In Figure 1, the drains actively expand to a 25 ° angle therebetween when the compressive force is not applied to reduce the angle between the drains. The drains in Figure 1 may be detachable. That is, the drains may be removed and replaced onto the y-shaped suction tube. [0049] In some embodiments of the present invention, the drains actively expand to a 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49 or 50 ° angle therebetween when the compressive force is not applied to reduce the angle between the drains.

[0050] Figure 2 shows one embodiment of a device encompassed by the present invention when vaginally inserted. In Figure 1, the angle between drains actively expands to contact the lateral vaginal fornices of the vagina when a compressive force is not applied to reduce the angle between the drains. In Figure 2, the vertex of the y-shaped suction tube is inserted inside the vestibule.

[0051] In some embodiments of the devices set forth herein, the drains may contact the cervix. In some other embodiments of the devices set forth herein, the pores in the drain may be of the same size. In other embodiments of the devices set forth herein, the pores in the drains may be of different sizes. In still other embodiments of the devices set forth herein, the pores in the drains may be positioned in a layered or overlapping design.

[0052] In some embodiments, the drains are the same size. In some other embodiments, the drains are of different sizes. [0053] Figure 3 shows another embodiment of a device encompassed by the present invention. The device in Figure 3 is a y-shaped device. In this device, two drains are attached to a y-shaped suction tube so as to form the smallest possible angle therebetween. In between the drains is an inflatable balloon. This inflatable balloon may be filled with saline, water, air, or any biocompatible gas or liquid. In some embodiments, the inflatable balloon may be filled with saline after it is vaginally inserted. Figure 3 shows that there is a channel or tube that runs up the middle of the y-shaped suction tube and makes contact with the inflatable balloon. In the device of Figure 3, this aforementioned channel or tube can fill the inflatable balloon with saline. When the inflatable balloon fills, the angle between the drains is expanded. In some embodiments of the devices set forth herein, the inflatable balloon is filled and the angle between the drains increases to 2, 3, 4, 5, 7, 8, 9, 10, 1 1, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, or 50 °. In Figure 3, the drains are porous. The drains in Figure 3 are cylindrical with an approximate diameter of 1 cm. The distance from the end of the drains to the vertex of the y-shaped suction tube is approximately 11.5 cm The tube inside the suction tube which transmits fluids to the inflatable balloon is approximately 12 cm long. In some other embodiments of the devices set forth herein, when the inflatable balloon fills with saline, the drains contact the lateral vaginal fornices of the vagina when the device is also vaginally inserted. In some embodiments of the devices set forth herein, the inflatable balloon is inflated when it is filled with the 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, or 5.5 ml of saline.

[0054] In some embodiments, the device includes a septum, a seal, and, or an expansion chamber which can be used to form a seal between the device and the patient on which the device is used. For example, the invention may include an expansion chamber around the suction tube which forms a seal with the patient's vaginal wall when the expansion chamber is expanded. [0055] In some embodiments, a balloon device such as, but not limited to, an inflatable balloon as described herein is used to keep the device inside the vagina and securely contacting the inner vaginal wall. In certain embodiments, the contacting is such that no blood or fluid can escape the vaginal opening by way of a gap between the vaginal wall and the device inserted in the vagina.

[0056] In some other embodiments, a balloon device is used to keep the device inside the vagina and securely contacting the inner vaginal wall. In certain embodiments, the contacting is such that no blood or fluid can escape the vaginal opening when the device is inserted. [0057] In other embodiments, the suction device maintains an adequate pressure that is not disruptive of the seal between the device and the inner vaginal wall.

[0058] In some embodiments, the balloon described herein is used to secure the device while it is inserted into the vagina.

[0059] In some other embodiments, the balloon described herein is used to seal the device to the inner wall of the vagina to prevent blood loss from the vaginal opening and redirect the blood or fluid into the device, as set forth herein.

[0060] The balloon device described herein may be used with any of the embodiments which are described herein.

[0061] Figure 4 shows another embodiment of a device encompassed by the present invention when it is vaginally inserted. In this device, an inflatable balloon is positioned between the drains. When the inflatable balloon is inflated, the angle between the drains is expanded and the drains contact the lateral vaginal fornices of the vagina.

[0062] Figure 5 shows yet another embodiment of a device encompassed by the present invention. The embodiment shown in Figure 5 has one drain attached to a suction tube. Also included is an inflatable balloon which forms a cylindrical donut shell around the suction tube. This inflatable balloon can be filled with saline or other liquids or gases to form a seal with the vaginal opening or vaginal wall. In some embodiments, the inflatable balloon is filled with 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 1 1, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, or 30 ml of fluid. The drain in Figure 5 is cylindrical and porous and approximately 7 cm long and 1.5 cm in diameter. A tube is positioned inside the suction tube to transmit fluids to the inflatable balloon.

[0063] Figure 6 shows yet another embodiment of a device encompassed by the present invention when vaginally inserted. In Figure 6, an inflatable balloon helps to form a seal between the inner vaginal wall and the suction tube which is connected to a single drain. The drain is porous. The inflatable balloon is inflated with approximately 30 ml of fluid. The drain is in contact with the cervix. In some embodiments of these devices, the end of the drain may contact a fornix of the vagina.

[0064] In any of the devices set forth herein, the drains may be reversibly detachable from the suction tube. In some of the embodiments, the drains and the suction tube form one continuous material which is not reversibly detachable. In some embodiments, the drain and the suction tube form a seamless connection therebetween.

[0065] In some embodiments, the present invention provides a biocompatible medical device that includes a flexible Y-shaped suction tube having three ends and which includes two rigid and porous drains attached to two of the three ends. The drains are sized and angled to contact the posterior vaginal fornix when vaginally inserted. The drains may be rounded or shaped to provide a comfortable contact with certain areas within the vagina or vaginal canal. The drains may have dimension of 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or 12 cm long. The drains may be cylindrical and be 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 14, 15, 16, 17, 18, 19, 20, 30, 40, 50, 60, 70, 80, 90, or 100 mm wide. In other embodiments, the drains may be cylindrical and be 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 14, 15, 16, 17, 18, 19, 20, 30, 40, 50, 60, 70, 80, 90, or 100 mm in diameter. In some of these embodiments, the angle between the drains increases when a compressive force is not applied to reduce the angle between the drains. Furthermore, in other of these embodiments, a vacuum collection component is also included wherein the component is in fluid communication with the end of the tube not directly attached to a drain. In some of these embodiments, the component has means for signaling for the collection of a critical amount of blood. Also, in some of these embodiments, the component is capable of collecting at least 500 ml of fluid.

[0066] In some other embodiments, the present invention also provides a biocompatible medical device including a flexible v-shaped suction tube having three ends, and which include two rigid and porous drains attached to two of the three ends. In certain embodiments, the drains are sized and angled to contact the posterior vaginal fornix when vaginally inserted. In some of these devices, the angle between the drains increases when a compressive force is not applied to reduce the angle between the drains. In some

embodiments, the drains actively expand when a compressive force is not applied. In other embodiments, the drains actively expand to a particular angle when a compressive force is not applied. In some embodiments, this particular angle includes 10, 1 1, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, or 30 ° between two drains. In some embodiments, a vacuum collection component is also included. In some embodiments, the component is in fluid communication with the end of the tube not directly attached to a drain. In some of these embodiments, the component has means for signaling for the collection of a critical amount of blood. These means include any of the means for signaling set forth herein. In some embodiments, the component is capable of collecting at least 500 ml of fluid. In others, the component is capable of collecting at least 1000 ml of fluid. In still others, the component is capable of collecting at least 1500 ml of fluid. In others, the component is capable of collecting at least 2000 ml of fluid. In others, the component is capable of collecting at least 2500 ml of fluid.

[0067] In some embodiments, the present invention provides a biocompatible medical device including a flexible suction tube having two ends and which includes at least one drain attached to one end. In some embodiments, the drain is sized and angled to contact the posterior vaginal fornix when vaginally inserted. Also included is a vacuum collection component which is in fluid communication with the end of the tube not directly attached to a drain. In some embodiments, the component has means for signaling for the collection of a critical amount of blood. These means include any of the means for signaling set forth herein. In some embodiments, the component is capable of collecting at least 500 ml of fluid. In others, the component is capable of collecting at least 1000 ml of fluid. In still others, the component is capable of collecting at least 1500 ml of fluid. In others, the component is capable of collecting at least 2000 ml of fluid. In others, the component is capable of collecting at least 2500 ml of fluid.

[0068] As show in Figures 7 and 8, some embodiments of the present invention include a cage or grill that is attached to the outside of the suction device to protect the drains. The cage has pores which are larger than the pores in the drain. The cage or grill functions to prevent the inner vaginal wall from collapsing against the surface of the drain when in operation.

[0069] In certain embodiments, the holes of the cage or grill are the same size. In other embodiments, the holes of the cage or grill are different sizes. In some of these

embodiments, the holes of the cage are 0.1, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 mm in diameter. In some other of these embodiments, the holes of the cage or grill are 0.01, 0.05, 0.07, 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 cm in diameter. In some other of these embodiments, the holes are 0.1, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 cm in diameter. In some of these embodiments, the holes of the cage or grill are larger than the holes in the suction device.

[0070] In some embodiments, described herein, the suction device or drains, described herein, has a plurality of holes through which blood or fluid is transmitted when the device is operating. In certain embodiments, the holes are the same size. In other embodiments, the holes are different sizes. In some of these embodiments, the holes are 0.1, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 mm in diameter. In some other of these embodiments, the holes are 0.01, 0.05, 0.07, 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 cm in diameter. In some other of these embodiments, the holes are 0.1, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 cm in diameter. In some of these embodiments, the holes are 0.1, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 mm in diameter. [0071] In some embodiments of the devices set forth herein, the drain is porous. In certain embodiments of the devices set forth herein, the length of the drain is about 20, about 18, about 16, about 14, about 12, about 10, about 8, about 6, about 4, about 2, or about 1 cm. In other embodiments of the devices set forth herein, the length of the drain is about 20, about 18, about 16, about 14, about 12, about 10, about 8, about 6, about 4, about 2, or about 1 mm. In some embodiments of the devices set forth herein, the width of the drain is about 10, about 8, about 6, about 4, about 2, or about 1 cm. In other embodiments of the devices described herein, the width of the drain is about 10, about 8, about 6, about 4, about 2, or about 1 mm.

[0072] In some embodiments of the devices described herein, the devices include a means for securing a Foley catheter. Examples include but are not limited to a thigh band, adhesive tape, adhesive glue, other mechanical means, clips, hoses, ties artifices and devices for securing a Foley catheter and the suction tube to a patient in need thereof. [0073] In other embodiments of the devices described herein, the drain material is different than the suction tube material.

[0074] In some embodiments of the devices described herein, the drains are in fluid communication with a vacuum pump. [0075] In other embodiments of the devices described herein, the distance between the ends of the two drains is about 56 mm when a compressive force is not applied to reduce the angle between the drains. In some other embodiments of the devices described herein, the distance between the ends of the two drains is about 56 mm when a compressive force is not applied to reduce the angle between the drains. In yet other embodiments of the devices described herein, the distance between the ends of the two drains is about 54mm when a compressive force is not applied to reduce the angle between the drains. In certain other embodiments of the devices described herein, the distance between the ends of the two drains is about 52mm when a compressive force is not applied to reduce the angle between the drains. In yet other embodiments of the devices described herein, the distance between the ends of the two drains is about 50mm when a compressive force is not applied to reduce the angle between the drains. In some other embodiments of the devices described herein, the distance between the ends of the two drains is about 48mm when a compressive force is not applied to reduce the angle between the drains. In still other embodiments of the devices described herein, the distance between the ends of the two drains is about 46 mm when a compressive force is not applied to reduce the angle between the drains. In some other embodiments of the devices described herein, the distance between the ends of the two drains is about 44mm when a compressive force is not applied to reduce the angle between the drains. In certain other embodiments of the devices described herein, the distance between the ends of the two drains is about 42mm when a compressive force is not applied to reduce the angle between the drains. In other embodiments of the devices described herein, the distance between the ends of the two drains is about 40mm when a compressive force is not applied to reduce the angle between the drains. In some other embodiments of the devices described herein, the distance between the ends of the two drains is about 38mm when a compressive force is not applied to reduce the angle between the drains. In other embodiments of the devices described herein, the distance between the ends of the two drains is about 36mm when a compressive force is not applied to reduce the angle between the drains. In some other embodiments of the devices described herein, the distance between the ends of the two drains is about 34mm when a compressive force is not applied to reduce the angle between the drains. In yet other embodiments of the devices described herein, the distance between the ends of the two drains is about 32mm when a compressive force is not applied to reduce the angle between the drains. In other embodiments of the devices described herein, the distance between the ends of the two drains is about 30mm when a compressive force is not applied to reduce the angle between the drains. In some other embodiments of the devices described herein, the distance between the ends of the two drains is about 28mm when a compressive force is not applied to reduce the angle between the drains. In yet other embodiments of the devices described herein, the distance between the ends of the two drains is about 26 mm when a compressive force is not applied to reduce the angle between the drains. In still other embodiments of the devices described herein, the distance between the ends of the two drains is about 24mm when a compressive force is not applied to reduce the angle between the drains. In certain other embodiments of the devices described herein, the distance between the ends of the two drains is about 22mm when a compressive force is not applied to reduce the angle between the drains. In other embodiments of the devices described herein, the distance between the ends of the two drains is about 20mm when a compressive force is not applied to reduce the angle between the drains. In some other embodiments of the devices described herein, the distance between the ends of the two drains is about 18 mm when a compressive force is not applied to reduce the angle between the drains. In yet other embodiments of the devices described herein, the distance between the ends of the two drains is about 16 mm when a compressive force is not applied to reduce the angle between the drains. In other embodiments, the distance between the ends of the two drains is about 14 mm when a compressive force is not applied to reduce the angle between the drains. In other embodiments of the devices described herein, the distance between the ends of the two drains is about 12 mm when a compressive force is not applied to reduce the angle between the drains. In some other embodiments of the devices described herein, the distance between the ends of the two drains is about 10 mm when a compressive force is not applied to reduce the angle between the drains. In some other embodiments of the devices described herein, the distance between the ends of the two drains is about 8 mm when a compressive force is not applied to reduce the angle between the drains. In some other embodiments of the devices described herein, the distance between the ends of the two drains is about 6 mm when a compressive force is not applied to reduce the angle between the drains. In some embodiments of the devices described herein, the distance between the ends of the two drains is about 4 mm when a compressive force is not applied to reduce the angle between the drains. In other embodiments of the devices described herein, the distance between the ends of the two drains is about 2 mm when a compressive force is not applied to reduce the angle between the drains. In some other embodiments of the devices described herein, the distance between the ends of the two drains is about 1 mm when a compressive force is not applied to reduce the angle between the drains.

[0076] In some embodiments of the devices described herein, the angle between the drains increases to about 180 ° when a compressive force is not applied to reduce the angle between the drains. In some embodiments of the devices described herein,the angle between the drains increases to about 150 ° when a compressive force is not applied to reduce the angle between the drains. In some embodiments of the devices described herein, the drains increases to about 120 ° when a compressive force is not applied to reduce the angle between the drains. In some embodiments of the devices described herein, the angle between the drains increases to about

90 ° when a compressive force is not applied to reduce the angle between the drains. In some other embodiments of the devices described herein, the angle between the drains increases to about 85 ° when a compressive force is not applied to reduce the angle between the drains. In some embodiments of the devices described herein, the drains increases to about 80 ° when a compressive force is not applied to reduce the angle between the drains. [0077] In some other embodiments of the devices described herein, the angle between the drains increases to about 75 ° when a compressive force is not applied to reduce the angle between the drains. In other embodiments of the devices described herein, the angle between the drains increases to about 70 ° when a compressive force is not applied to reduce the angle between the drains. In some embodiments of the devices described herein, the angle between the drains increases to about 65 ° when a compressive force is not applied to reduce the angle between the drains. In some other embodiments of the devices described herein, the angle between the drains increases to about 60 ° when a compressive force is not applied to reduce the angle between the drains. In other embodiments of the devices described herein, the angle between the drains increases to about 55 ° when a compressive force is not applied to reduce the angle between the drains. In some other embodiments of the devices described herein, the angle between the drains increases to about 50 ° when a compressive force is not applied to reduce the angle between the drains. In some embodiments of the devices described herein, the angle between the drains increases to about 45 ° when a compressive force is not applied to reduce the angle between the drains. In some embodiments of the devices described herein, the angle between the drains increases to about 40 ° when a compressive force is not applied to reduce the angle between the drains. In other

embodiments of the devices described herein, the angle between the drains increases to about 35 ° when a compressive force is not applied to reduce the angle between the drains. In some embodiments of the devices described herein, the angle between the drains increases to about 30 ° when a compressive force is not applied to reduce the angle between the drains. In other embodiments of the devices described herein, the angle between the drains increases to about 25 ° when a compressive force is not applied to reduce the angle between the drains. In some other embodiments of the devices described herein, the angle between the drains increases to about 20 ° when a compressive force is not applied to reduce the angle between the drains. In other embodiments of the devices described herein, the angle between the drains increases to about 15 ° when a compressive force is not applied to reduce the angle between the drains. In some other embodiments of the devices described herein, the angle between the drains increases to about 10 ° when a compressive force is not applied to reduce the angle between the drains. In some other embodiments of the devices described herein, the angle between the drains increases to about 5 ° when a compressive force is not applied to reduce the angle between the drains. In some other embodiments of the devices described herein, the angle between the drains increases so that the drains contact the lateral fornices of the vagina.

[0078] In some other embodiments of the devices described herein, also included is a means for preventing the inner vaginal wall from collapsing against the suction tube. In other embodiments of the devices described herein, also included is a means for preventing the inner vaginal wall from reducing the suction capacity of the suction tube. In some of these embodiments of the devices described herein, the means includes, but is not limited to, a cage, a porous framework which encapsulates the ends of the device of claim 1 which are in contact with the vaginal wall. In some other embodiments of the devices described herein, the means includes a cage, a porous framework which encapsulates the ends of the device of claim 1 which are in contact with the vaginal wall. [0079] In some other embodiments of the devices described herein, also included is a filter attached to a drain pore. [0080] In some other embodiments of the devices described herein, also included are a means for signaling for the collection of a critical amount of blood. In some of these embodiments, the means for signaling include an alarm, a bell, a generated sound, a signal, a light, a flash, a vibration, a digital displayed message, a auditory alarm, a visual alarm, a wireless alarm, an alarm controlled, in part, with Bluetooth wireless technology, or a signal controlled, in part, with Bluetooth wireless technology.

[0081] In some other embodiments of the devices described herein, the means for signaling for the collection of a critical amount of blood are activated when 250 ml of fluid is collected. In other embodiments of the devices described herein, the means for signaling for the collection of a critical amount of blood are activated when 500 ml of fluid is collected. In some embodiments of the devices described herein, the means for signaling for the collection of a critical amount of blood are activated when 1 L of fluid is collected. In some other embodiments of the devices described herein, the means for signaling for the collection of a critical amount of blood are activated when 1.5 L of fluid is collected. In other embodiments of the devices described herein, the critical amount of blood is 500 ml.

[0082] In some other embodiments of the devices described herein, the critical amount of blood is 1 L. In other embodiments of the devices described herein, the critical amount of blood is 1.5 L. In some embodiments of the devices described herein, the critical amount of blood is 2 L. In other embodiments of the devices described herein, the critical amount of blood is 2.5 L.

[0083] In some embodiments of the devices described herein, the tube, the drains, and the components are made from materials selected from the group consisting of

polytetrafluoroethylene (PTFE), polypropylene, high density polyethylene (HDPE), and low density polyethylene (LDPE). [0084] In some other embodiments of the devices described herein, at least one drain is detachable.

[0085] In some other embodiments of the devices described herein, the vacuum collection component comprises an aspirator. IV. Methods

[0086] The present invention provides methods for quantifying blood loss during a Cesarean section procedure.

[0087] In some embodiments, the present invention provides methods for collecting blood during a Cesarean section procedure using a device described herein and including the steps of 1) applying a compressive force to reduce the angle between the drains; 2) inserting the device intra-vaginally; 3) allowing the angle between the drains to increase until the drains contact the lateral vaginal fornices; and 4) activating a vacuum pump that is in fluid communication with the device. [0088] In some other embodiment, the present invention provides methods for collecting blood during a Cesarean section procedure using a device described herein and including the steps of 1) inserting the device inside the vagina; 2) inflating the balloon with saline to increase the angle between the drains; and 3) activating a vacuum pump that is in fluid communication with the device. [0089] The inflatable balloon set forth herein may be of a variety of shapes, including but not limited to, a disk, a sphere, or a cylinder. In some embodiments, the balloon is a disk. In some embodiments, the balloon is a sphere. In some embodiments, the balloon is a cylinder.

[0090] In some other embodiment, the present invention provides methods for collecting blood during a Cesarean section procedure using a device described herein and including the steps of 1) inserting the device inside the vagina; and 2) activating a vacuum pump that is in fluid communication with the device.

[0091] In some other embodiments, the present invention provides methods for signaling for the collection of a critical amount of blood are collected during a Cesarean section procedure. These methods include using a device described herein. V. Patients in need thereof

[0092] The present invention provides devices, methods, systems, and kits, for collecting and quantifying the blood loss during a Cesarean section. In some embodiments, devices, methods, systems, and kits are useful for treating a patient in need thereof. [0093] In some embodiments, the patient in need of the devices, methods, systems, and kits, set forth herein, is a pregnant woman. In other embodiments, the patient in need thereof is a pregnant woman who is giving birth. In yet other embodiments, the patient in need thereof is a pregnant woman who is giving birth and is undergoing a Cesarean section operation. In other embodiments, the patient is a pregnant woman who is giving birth and is also hemorrhaging. In still other embodiments, the patient in need thereof is a woman who has given birth within the past 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 1 1, 12, 13, 14, 15 16, 17, 18, 19, 20, 21, 22, 23, 24, 48, or 72 hours.

[0094] In other embodiments, the present invention is useful for treating pregnant women who have hemodynamic compensatory mechanisms that may blunt the initial and, or, typical responses to blood loss, such as tachycardia and hypotension, until severe decompensation has occurred. In other embodiments, the patient is symptomatic of hypotension, dizziness, pallor or oliguria. In some other embodiments, the patient in need thereof has lost 15% or more of their total blood volume. [0095] In some embodiments, the devices and methods described herein are suited for use with female blood. In yet other embodiments, the y-shaped and v-shaped designs are sized and angled to contact the posterior fornix.

[0096] In some embodiments, the patient in need thereof has an obstetric hemorrhage. In other embodiments, the patient in need thereof may be classified into 1 of 4 groups with accompanying signs and symptoms. In one group, the patient in need thereof has lost 900 ml of blood or 15% of their circulating blood volume. In a second group, the patient in need thereof has lost 1200-1500 ml of blood or 20-25 % of their circulating blood volume. In some embodiments, the patient in need thereof has tachycardia. In some other embodiments, the patient has tachypnea with narrowed pulse pressure. In other embodiments, the patient in need thereof has orthostatic hypotension. In yet other embodiments, the patient in need thereof has tachycardia, tachypnea with narrowed pulse pressure and orthostatic hypotension. In a third group, the patient in need thereof has lost 1800-2100 ml of blood or 30-35% of their circulating blood volume. In some embodiments, the patient in need thereof has worsening tachycardia. In other embodiments, the patient in need thereof has hypotension. In still other embodiments, the patient in need thereof has cool extremities. In some embodiments, the patient in need thereof has worsening tachycardiaand tachypnea, hypotension and cool extremities. In a fourth group, the patient in need thereof has lost 2100 ml of blood or 40% of their circulating blood volume. In some embodiments, the patient in need thereof exhibits shock. In other embodiments, the patient in need thereof exhibits oliguria. In yet other embodiments, the patient exhibits anuria.In some embodiments, the patient in need thereof exhibits shock, oliguria and anuria.

[0097] In another embodiment, the patient in need thereof is undergoing vaginal birth and has no previous uterine incisions. In some embodiments, the patient in need thereof has had four or fewer previous vaginal births. In other embodiments, the patient in need thereof has a singleton pregnancy. In other embodiments, the patient is undergoing a Cesarean birth and has had no previous uterine incisions. In some embodiments, the patient in need thereof is in the first trimester of pregnancy. In other embodiments, the patient in need thereof is in the second trimester of pregnancy.

[0098] In some embodiments, the patient in need thereof is undergoing trial of labor after a cesarean section. In some other embodiments, the patient in need thereof has had previous cesarean sections and/or prior pelvic surgeries with suspected or known adhesions. In some embodiments, the patient in need thereof has uterine over-distention such as fetal macrosomia, polyhydramnios, or multi-fetal pregnancies. In other embodiments, the patient in need thereof has uterine fibroids. In still other embodiments, the patient in need thereof is undergoing an induced vaginal birth. [0099] In some embodiments, the patient in need thereof has been exposed to intrapartum medications such as oxytocin or other inducing agents. In other embodiments, the patient in need thereof has been exposed to magnesium sulfate for tocolysis. In some embodiments, the patient in need thereof has chorioamnionitis. In other embodiments, the patient in need thereof is morbidly obese. In some embodiments, the patient in need thereof has a body mass index greater than 35. In some other embodiments, the patient in need thereof has preeclampsia. In some embodiments, the patient in need thereof has a blood pressure of greater than or equal to 140 mm Hg, systolic, or greater than or equal to 90 mm Hg, diastolic, after 20 weeks gestation and proteinuria of greater than or equal to 300mg over 24 hours.

[0100] In some embodiments, the patient in need thereof is experiencing Placenta Previa. In some other embodiments, the patient in need thereof is experiencing suspected Placenta Accreta. In other embodiments, the patient in need thereof is experiencing placental abruption. In some embodiments, the patient in need thereof has a history of postpartum hemorrhage. In some embodiments, the patient in need thereof is experiencing Severe Preeclampsia. In some embodiments, the patient in need thereof has a history of Severe Preeclampsia as defined by blood pressure a greater than or equal to 160 mm Hg systolic or greater than or equal to 1 10 mm Hg diastolic. In some embodiments, the patient in need thereof is experiencing signs or symptoms of organ damage. In some embodiments, the patient in need thereof is experiencing amniotic fluid embolism. In some embodiments, the patient in need thereof is experiencing coagulopathy. In some embodiments, the patient in need thereof has a hematocrit less than 26 in the antepartum period. In other embodiments, the patient in need thereof is experiencing vaginal bleeding on admission to a hospital or other caregiving center. In some embodiments, the patient in need thereof is experiencing immune thrombocytopenic purpura or thrombocytopenia from other conditions such as gestational hypertension, TTP, HUS, HIV or vonWillebrand disease. In some embodiments, the patient in need thereof is experiencing grand multiparity greater than 5 previous deliveries.

VI. Examples

[0101] Example 1: Quantification of Blood Loss in a Cesarean Delivery Using the Present Invention

[0102] In some Examples, a y-shaped suction tube having two drains, and as described herein, is vaginally inserted in a woman prior to, or during, a Cesarean section procedure. An operating vacuum is connected to this device during the Cesarean section procedure.

[0103] During the procedure, approximately 1 L of blood is collected by the device and an alarm is sounded to alert the medical personnel that a critical amount of blood has been lost from the woman. [0104] Although the foregoing invention has been described in some detail by way of illustration and example for purposes of clarity of understanding, one of skill in the art will appreciate that certain changes and modifications may be practiced within the scope of the appended claims. In addition, each reference provided herein is incorporated by reference in its entirety to the same extent as if each reference was individually incorporated by reference. Where a conflict exists between the instant application and a reference provided herein, the instant application shall dominate. [0105] Example 2: Estimation of Blood Loss in a Cesarean Delivery Using Standard Practices

[0106] The dry weight of all surgical materials which may contact blood from a bleeding patient is quantified. After the Cesarean Delivery, the wet weight for all surgical materials having blood thereon is quantified. The amount of blood loss is estimated by subtracting the respect dry weight of each material from the wet weight of the same material. In addition, a visual inspection of the operating room, including a visual inspection of all drapes, clothes, and containers is performed to estimate the amount of blood loss from the patient. Materials for which the dry weight and wet weight are quantified include, but are not limited to, large and small cloths, disposable Chux, towels, lap pad (in the vaginal tray or in the operating room), sanitary pad, or an ice pack.

[0107] In one example, a patient undergoes a Cesarean section and a uterine incision. Thereafter, 200 ml of amniotic fluid is suctioned into a canister. Also, the dry weight of the lap pads used is 500 g. The wet weight of the lap pads used is 900 g. Thus, the amount of blood loss estimated from the difference in wet/dry weight is approximately 400 g.

[0108] Example 3 - Method of Using Devices Described Herein

[0109] In one example, after the vaginal birth of a baby and delivery of the placenta, a device, described herein, is vaginally inserted into the patient as set forth herein. Blood lost is collected by the device and quantified in the container in fluid communication therewith. [0110] The following examples are provided for illustrative purposes, and are not intended to limit the scope of the invention as claimed herein. Any variations in the exemplified compounds, compositions, and, or, methods which occur to the skilled artisan are intended to fall within the scope of the present invention. Although the foregoing invention has been described in some detail by way of illustration and example for purposes of clarity of understanding, one of skill in the art will appreciate that certain changes and modifications may be practiced within the scope of the appended claims. In addition, each reference provided herein is incorporated by reference in its entirety to the same extent as if each reference was individually incorporated by reference. Where a conflict exists between the instant application and a reference provided herein, the instant application shall dominate.

Claims

WHAT IS CLAIMED IS: 1. A biocompatible medical device comprising:
- a flexible Y-shaped suction tube having three ends and comprising two rigid and porous drains attached to two of the three ends;
- wherein the drains are sized and angled to contact the posterior vaginal fornix when vaginally inserted; and
- wherein the angle between the drains increases when a
compressive force is not applied to reduce the angle between the drains; and
- a vacuum collection component,
- wherein the component is in fluid communication with the end of the tube not directly attached to a drain;
- wherein the component has means for signaling for the collection of a critical amount of blood; and
- wherein the component is capable of collecting at least 500 ml of fluid.
2. A biocompatible medical device comprising:
- a flexible v-shaped suction tube having three ends,
- comprising two rigid and porous drains attached to two of the three ends;
- wherein the drains are sized and angled to contact the posterior vaginal fornix when vaginally inserted; and
- wherein the angle between the drains increases when a
compressive force is not applied to reduce the angle between the drains; and
- a vacuum collection component,
- wherein the component is in fluid communication with the end of the tube not directly attached to a drain;
- wherein the component has means for signaling for the collection of a critical amount of blood; and - wherein the component is capable of collecting at least 500 ml of fluid.
3. A biocompatible medical device comprising:
- a flexible suction tube having two ends,
- comprising at least one drain attached to one end; and
- wherein the drain is sized and angled to contact the posterior fornix when vaginally inserted; and
- a vacuum collection component,
- wherein the component is in fluid communication with the end of the tube not directly attached to a drain;
- wherein the component has means for signaling for the collection of a critical amount of blood; and
- wherein the component is capable of collecting at least 500 ml of fluid.
4. A biocompatible medical device having a drain attached to a suction tube wherein the drain is sized to contact the cervix when vaginally inserted.
5. A biocompatible medical device having a drain attached to a suction tube wherein the drain is sized and angled to contact a fornix when vaginally inserted.
6. The device of claims 1, 2, 3, 4, or 5 comprising an inflatable balloon that forms a seal with the inner vaginal wall when the device is vaginally inserted and the balloon is inflated.
7. The device of claims 1, 2, 3, 4, or 5 comprising an inflatable balloon that secures the device when vaginally inserted and the balloon is inflated.
8. The device of claims 1, 2, 3, 4, or 5 comprising an inflatable balloon that secures the device when vaginally inserted.
9. The device of claims 1 or 2 comprising an inflatable balloon between the drains which increases the angle between the drains when inflated and decreases the angle between the drains when deflated.
10. The device of claim 3, wherein the drain is porous.
1 1. The device of claims 1, 2, or 3, wherein the length of the drain is about 20, about 18, about 16, about 14, about 12, about 10, about 8, about 6, about 4, about 2, or about 1 cm.
12. The device of claims 1, 2, or 3, wherein the length of the drain is about 20, about 18, about 16, about 14, about 12, about 10, about 8, about 6, about 4, about 2, or about 1 mm.
13. The device of claims 1, 2, or 3, wherein the width of the drain is about 4, about 2, or about 1 cm.
14. The device of claims 1, 2, or 3, wherein the width of the drain is about 10, about 8, about 6, about 4, about 2, or about 1 mm.
15. The device of claims 1, 2, or 3, further comprising a means for securing a Foley catheter and the suction tube to a patient in need thereof.
16. The device of claims 1, 2, or 3, wherein the drain material is different than the suction tube material.
17. The device of claims 1, 2, or 3, wherein the drain material is the same as the suction tube material.
18. The device of claims 1, 2, or 3, in fluid communication with a vacuum pump.
19. The device of claims 1 or 2, wherein the distance between the ends of the two drains is about 20 mm when a compressive force is not applied to reduce the angle between the drains.
20. The device of claims 1 or 2, wherein the distance between the ends of the two drains is about 56 mm when a compressive force is not applied to reduce the angle between the drains.
21. The device of claims 1 or 2, wherein the distance between the ends of the two drains is about 50 mm when a compressive force is not applied to reduce the angle between the drains.
22. The device of claims 1 or 2, wherein the distance between the ends of the two drains is about 45 mm when a compressive force is not applied to reduce the angle between the drains.
23. The device of claims 1 or 2, wherein the distance between the ends of the two drains is about 40 mm when a compressive force is not applied to reduce the angle between the drains.
24. The device of claims 1 or 2, wherein the distance between the ends of the two drains is about 30 mm when a compressive force is not applied to reduce the angle between the drains.
25. The device of claims 1 or 2, wherein the distance between the ends of the two drains is about 20 mm when a compressive force is not applied to reduce the angle between the drains.
26. The device of claims 1 or 2, wherein the distance between the ends of the two drains is about 10 mm when a compressive force is not applied to reduce the angle between the drains.
27. The device of claims 1 or 2, wherein the distance between the ends of the two drains is about 8 mm when a compressive force is not applied to reduce the angle between the drains.
28. The device of claims 1 or 2, wherein the distance between the ends of the two drains is about 6 mm when a compressive force is not applied to reduce the angle between the drains.
29. The device of claims 1 or 2, wherein the distance between the ends of the two drains is about 4 mm when a compressive force is not applied to reduce the angle between the drains.
30. The device of claims 1 or 2, wherein the distance between the ends of the two drains is about 1 mm when a compressive force is not applied to reduce the angle between the drains.
31. The device of claims 1 or 2, wherein the angle between the drains increases to about 180 ° when a compressive force is not applied to reduce the angle between the drains.
32. The device of claims 1 or 2, wherein the angle between the drains increases to about 150 ° when a compressive force is not applied to reduce the angle between the drains.
33. The device of claims 1 or 2, wherein the angle between the drains increases to about 120 ° when a compressive force is not applied to reduce the angle between the drains.
34. The device of claims 1 or 2, wherein the angle between the drains increases to about 90 ° when a compressive force is not applied to reduce the angle between the drains.
35. The device of claims 1 or 2, wherein the angle between the drains increases to about 85 ° when a compressive force is not applied to reduce the angle between the drains.
36. The device of claims 1 or 2, wherein the angle between the drains increases to about 80 ° when a compressive force is not applied to reduce the angle between the drains.
37. The device of claims 1 or 2, wherein the angle between the drains increases to about 75 ° when a compressive force is not applied to reduce the angle between the drains.
38. The device of claims 1 or 2, wherein the angle between the drains increases to about 70 ° when a compressive force is not applied to reduce the angle between the drains.
39. The device of claims 1 or 2, wherein the angle between the drains increases to about 65 ° when a compressive force is not applied to reduce the angle between the drains.
40. The device of claims 1 or 2, wherein the angle between the drains increases to about 60 ° when a compressive force is not applied to reduce the angle between the drains.
41. The device of claims 1 or 2, wherein the angle between the drains increases to about 55 ° when a compressive force is not applied to reduce the angle between the drains.
42. The device of claims 1 or 2, wherein the angle between the drains increases to about 50 ° when a compressive force is not applied to reduce the angle between the drains.
43. The device of claims 1 or 2, wherein the angle between the drains increases to about 45 ° when a compressive force is not applied to reduce the angle between the drains.
44. The device of claims 1 or 2, wherein the angle between the drains increases to about 40 ° when a compressive force is not applied to reduce the angle between the drains.
45. The device of claims 1 or 2, wherein the angle between the drains increases to about 35 ° when a compressive force is not applied to reduce the angle between the drains.
46. The device of claims 1 or 2, wherein the angle between the drains increases to about 30 ° when a compressive force is not applied to reduce the angle between the drains.
47. The device of claims 1 or 2 wherein the angle between the drains increases to about 25 ° when a compressive force is not applied to reduce the angle between the drains.
48. The device of claims 1 or 2, wherein the angle between the drains increases to about 20 ° when a compressive force is not applied to reduce the angle between the drains.
49. The device of claims 1 or 2, wherein the angle between the drains increases to about 15 ° when a compressive force is not applied to reduce the angle between the drains.
50. The device of claims 1 or 2, wherein the angle between the drains increases to about 10 ° when a compressive force is not applied to reduce the angle between the drains.
51. The device of claims 1 or 2, wherein the angle between the drains increases to about 5 ° when a compressive force is not applied to reduce the angle between the drains.
52. The device of claims 1 or 2, further comprising a means for preventing the inner vaginal wall from collapsing against the suction tube.
53. The device of claims 1 or 2, further comprising a means for preventing the inner vaginal wall from reducing the suction capacity of the suction tube.
54. The device of claims 52, wherein the means comprise a cage, a porous framework which encapsulates the ends of the device of claim 1 which are in contact with the vaginal wall.
55. The device of claims 53, wherein the means comprise a cage, a porous framework which encapsulates the ends of the device of claim 1 which are in contact with the vaginal wall.
56. The device of claim 52, optionally comprising a filter attached to a drain pore.
57. The device of claims 1, 2, or 3 wherein the means for signaling for the collection of a critical amount of blood are selected from the group consisting of an alarm, a bell, a generated sound, a signal, a light, a flash, a vibration, a digital displayed message, a auditory alarm, a visual alarm, a wireless alarm, an alarm controlled, in part, with Bluetooth wireless technology, or a signal controlled, in part, with Bluetooth wireless technology.
58. The device of claim 57, wherein the means for signaling for the collection of a critical amount of blood are activated when 250 ml of fluid is collected.
59. The device of claim 57, wherein the means for signaling for the collection of a critical amount of blood are activated when 500 ml of fluid is collected.
60. The device of claim 57, wherein the means for signaling for the collection of a critical amount of blood are activated when 1 L of fluid is collected.
61. The device of claim 57, wherein the means for signaling for the collection of a critical amount of blood are activated when 1.5 L of fluid is collected.
62. The device of claims 1, 2, or 3, wherein the critical amount of blood is 500 ml.
63. The device of claims 1, 2, or 3 wherein the critical amount of blood is 1 L.
64. The device of claims 1, 2, or 3, wherein the critical amount of blood is 1.5 L.
65. The device of claims 1, 2, or 3, wherein the critical amount of blood is 2 L.
66. The device of claims 1, 2, or 3, wherein the critical amount of blood is 2.5 L.
67. The device of claims 1, 2, or 3, wherein the tube, the drains, and the components are made from materials selected from the group consisting of polytetrafluoroethylene (PTFE), polypropylene, high density polyethylene (HDPE), and low density polyethylene (LDPE).
68. The device of claims 1, 2, or 3, wherein at least one drain is detachable.
69. The device of claims 1, 2, or 3, wherein the vacuum collection component comprises an aspirator.
70. A method of collecting blood during a Cesarean section procedure using the device of claim 1, comprising the following steps:
- applying a compressive force to reduce the angle between the drains;
- inserting the device intra-vaginally;
- allowing the angle between the drains to increase until the drains contact the lateral vaginal fornices; and
- activating a vacuum pump that is in fluid communication with the device.
71. A method for signaling for the collection of a critical amount of blood are collected during a Cesarean section procedure, comprising using a device of claims 1, 2, or 3.
PCT/US2013/066451 2012-10-23 2013-10-23 Blood loss monitoring and quantification devices, systems, and methods WO2014066547A1 (en)

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