Uterine hemorrhage controlling system and method

Abstract

A method of reducing postpartum bleeding includes positioning a device comprising a vacuum element within the uterus; sealing the uterus; activating vacuum in the uterus with the vacuum element of the device while the uterus is sealed; and collapsing the uterus with the vacuum to reduce postpartum bleeding.

Description

TECHNICAL FIELD

[0001] This invention relates generally to the medical device field, and more specificallyto an improved uterine hemorrhage controlling system and method.BACKGROUND

[0002] Postpartum uterine bleeding can occur when the uterine muscles are unable toachieve adequate contraction after delivery to cut off the blood flow that formerlycirculated in the utero-placental space to nourish the unborn child(ren). The condition forthis lack of contraction is called atony (lack of tone). The mechanism by which thecontraction of the uterine muscles typically cuts off the blood flow is by a cross-hatchconfiguration of the myometrium whereby contraction of the muscles of the cross-hatchconfiguration effectively pinch the arterial vessels that run through the cross-hatchsections. In some cases, atony can result in arterial vessels that continue to bleed into theuterus (i.e., postpartum uterine bleeding). The rate of bleeding can vary from a trickle towhat is described as faucet flow, which can have a flow rate similar to the placental flowto the fetus at full term (approximately 750 ml / min).

[0003] Postpartum hemorrhage, or excessive uterine blood loss after birth, is the leadingcause of maternal death in the world, claiming the lives of over 125,000 mothers everyyear. Inability to control postpartum bleeding can require a woman to receive multipleblood transfusions, and in severe cases, a full hysterectomy. Accordingly, it is desirableto control such postpartum bleeding, if possible, at its onset. The cause of postpartumhemorrhage, in approximately 80% of cases, is uterine atony, which is the inability of thewoman's uterus to contract after delivering the child. Risk factors for uterine atonyinclude prolonged stage of labor, preeclamsia, and multiparity.

[0004] Postpartum hemorrhage has been traditionally treated using oxytoxic agents,hormonal agents that induce muscle contraction. Unfortunately, studies have increasinglyshown that oxytoxic agents do not significantly reduce either the incidence of postpartumhemorrhage or the amount of blood lost. Some studies have even indicated that oxytoxicagents are being overused to the point that this treatment increases the risk of uterineatony. Current medical devices and surgical procedures have also proven inadequate inreducing postpartum hemorrhage or the amount of blood lost, and / or are extremelyinvasive.

[0005] It has recently been discovered by the inventors that providing negative pressure(i.e., vacuum) within the uterus, in combination with sealing an opening to the uterus orvagina at the distal end, can rapidly induce uterine contraction to counteract uterineatony, thus reducing or entirely stopping uterine hemorrhaging. Providing negativepressure may furthermore be performed in a non-invasive (i.e., non-surgical) manner,effectively removing an inadequacy of other hemorrhage-controlling options. With theknowledge of this discovery, the inventors have created an improved uterine hemorrhagecontrolling system and method.SUMMARY OF THE DISCLOSURE

[0006] In general, in one embodiment, a method of reducing postpartum bleedingincludes positioning a device having a vacuum element at least partially within the uterus,sealing the uterus, activating vacuum in the uterus with the vacuum element of the devicewhile the uterus is sealed, and collapsing the uterus with the vacuum to reducepostpartum bleeding.

[0007] This and other embodiments can include one or more of the following features.Positioning the device can include transvaginally delivering the vacuum element to theuterus. The method can further include reversibly deforming the vacuum element prior topositioning the device within the uterus. The vacuum element can include a plurality ofopenings. Activating vacuum can include activating vacuum through the plurality ofopenings. Collapsing the uterus can include collapsing tissue onto a shield of the deviceso as to prevent obstruction of the plurality of openings. The vacuum element can becurved. The plurality of openings can be positioned along an inner circumference of thecurved vacuum element. Sealing the uterus can include placing the seal at the vulva,cervix, or vaginal canal. Sealing the uterus can include expanding a seal against tissueproximate to or within the uterus. Expanding the seal can include delivering fluid to aninterior of the seal. Activating vacuum can include activating vacuum with a vacuumpump connected to the vacuum element. Activating vacuum can include producing anegative pressure within the uterus of up to 3 psi. The method can further includeremoving fluid from the uterus after activating vacuum. Activating vacuum cancounteract uterine atony. Activating vacuum can facilitate closing of exposed uterinearterioles in a wall of the uterus. The method can further include maintaining vacuumuntil hemorrhaging has substantially stopped. The method can further includemaintaining vacuum for 1-24 hours. The method can further include monitoring a flow ofblood out of the uterus while vacuum is activated. Monitoring the flow of blood caninclude monitoring through a transparent portion of the device.

[0008] In general, in one embodiment, a method of reducing postpartum bleedingincludes positioning a device having a vacuum element at least partially within a uterus,sealing the uterus with a seal of the device, activating vacuum in the uterus with thevacuum element of the device while the uterus is sealed, and collapsing endometrialtrumpet-shaped arteries at an inner surface of the uterus with the vacuum to reducepostpartum bleeding.

[0009] This and other embodiments can include one or more of the following features.The method can further include collapsing the uterus with the vacuum to causecontraction of uterine muscles and reduce postpartum bleeding. Activating vacuum caninclude supplying vacuum from a pump at between 1 L / min and 20 L / min. Activatingvacuum can include supplying vacuum from a pump at between 10 L / min and 15 L / min.Activating vacuum can include producing a pressure of 40-160 mmHg. Activatingvacuum can include producing a pressure of 50-100 mmHg. Activating vacuum caninclude producing a pressure of 70-90 mmHg. Sealing the uterus can include placing theseal in the lower uterus, cervix, vaginal canal, or at the vulva. Sealing the uterus caninclude sealing so as to hinder a flow of air into the uterus while vacuum is applied inorder to achieve a therapeutic isobaric level of vacuum throughout the uterus. Themethod can further include maintaining an isobaric condition within the uterus afteractivating vacuum. Activating vacuum can include activating with a pump having avacuum reservoir therein so as to enable a consistent flow of vacuum to the uterus. Themethod can further include detecting air in a tube connected to the vacuum element todetermine if there is a leak in a seal. The method can further include visualizing a flow ofblood from the uterus through a translucent or transparent tube connected to the vacuumelement. The steps of positioning, sealing, activating, and collapsing can result instopping postpartum bleeding within 5 hours. The steps of positioning, sealing,activating, and collapsing can result in stopping postpartum bleeding within 2 hours. Themethod can further include confirming that a cervix is dilated to greater than 3 cm priorto the positioning step. A leak rate past the seal can be less than a pump rate of a pumpsupplying the vacuum.

[0010] In general, in one embodiment, a method of reducing postpartum bleedingincludes positioning a device comprising a vacuum element at least partially within auterus, sealing the uterus with a seal of the device, activating vacuum in the uterus withthe vacuum element of the device while the uterus is sealed, collapsing the uterus withthe vacuum, and maintaining an isobaric condition within the uterus after activatingvacuum to reduce postpartum bleeding.

[0011] In general, in one embodiment, a system configured to treat postpartumhemorrhaging includes a suction module and a pump system. The suction moduleincludes a vacuum element and a sealing portion. The vacuum element is configured tobe placed within a uterus and includes a plurality of holes therein. The sealing portion isconnected to the vacuum element and has a seal configured to seal the uterus. The pumpsystem is configured to connect to the suction module so as to activate vacuum in theuterus through the vacuum element. The pump system includes a pump, a vacuumreservoir, and a pressure regulator configured to regulate a pressure between the vacuumreservoir and the suction module so as to maintain a substantially constant vacuum withinthe uterus.

[0012] This and other embodiments can include one or more of the following features.The pump can be an intermittent pump. The pump can be a manual pump. The pump canbe configured to draw a vacuum that is higher than a vacuum through the suction module.The pump system can further include a pressure gauge connected to the vacuum reservoirand configured to indicate a pressure in the vacuum reservoir. The pump system canfurther include a separation canister configured to prevent fluids from reaching thepressure regulator.

[0013] In general, in one embodiment, a system configured to treat postpartumhemorrhaging includes a suction module and a connecting tube. The suction moduleincludes a vacuum element and a sealing portion. The vacuum element is configured tobe placed within a uterus and includes a plurality of holes therein. The sealing portion isconnected to the vacuum element and has a seal configured to seal the uterus. Theconnecting tube is connected to the suction module and is configured to connect to avacuum pump to as to activate vacuum in the uterus through the vacuum element. Theconnecting tube is transparent or translucent so as to enable viewing of a flow of bloodtherethrough.

[0014] In general, in one embodiment, a system configured to treat postpartumhemorrhaging includes a suction module and a connecting tube. The suction moduleincludes a vacuum element and a sealing portion. The vacuum element is configured tobe placed within a uterus and includes a plurality of holes therein. The sealing portion isconnected to the vacuum element and has a seal configured to seal the uterus. Theconnecting tube is connected to the suction module and is configured to connect to avacuum pump to as to activate vacuum in the uterus through the vacuum element. Thevacuum is configured to collapse endometrial trumpet-shaped arteries at an inner surfaceof the uterus to reduce postpartum bleeding.

[0015] Any of these embodiments can include one or more of the following. Thevacuum can be configured to collapse the uterus to cause contraction of uterine musclesand reduce postpartum bleeding. The seal can be configured to be positioned in the loweruterus, cervix, vaginal canal, or at the vulva. The vacuum element can be looped. Theplurality of holes can be positioned along an interior surface of the looped vacuumelement. The system can further include a shield coupled to and extending along thevacuum element. The vacuum element can be atraumatic.

[0016] The seal can be configured to expand from a collapsed configuration to anexpanded configuration.BRIEF DESCRIPTION OF THE FIGURESFIGURE 1 depicts an embodiment of a uterine hemorrhage controlling system;FIGURES 2A-2C depict variations of a suction tube and shield of an embodiment of auterine hemorrhage controlling system;

[0017] FIGURE 3A depicts a specific example of a uterine hemorrhage controllingsystem;

[0018] FIGURES 3B and 3C depict cross-sectional views of suction tube connectingjoints;

[0019] FIGURE 3D shows an example of a suction tube cross section and opening;

[0020] FIGURES 4A and 4B depict examples of suction tubes that also function asshields;

[0021] FIGURE 4C depicts an example of a system that combines variations of elements;

[0022] FIGURES 5A-5B depict examples of an inflatable sealing module element;

[0023] FIGURES 6 and 7 depict examples of sealing module variations;

[0024] FIGURES 8A and 8B depict examples of system elements with dual functionality;

[0025] FIGURE 9 depicts an embodiment of steps of a uterine hemorrhage controllingmethod;

[0026] FIGURES 10-11 depict embodiments of steps of a uterine hemorrhage controllingmethod; and

[0027] FIGURE 12 is a schematic showing an implementation of an embodiment of auterine hemorrhage controlling method;

[0028] FIGURE 13A is depicts an embodiment of a uterine hemorrhage controllingsystem;

[0029] FIGURE 13B depicts the uterine hemorrhage controlling system of Figure 13Aviewed from the side;

[0030] FIGURE 14 is a graph comparing the bleeding control success rate of the uterinehemorrhage controlling system described herein relative to a Bakri device;

[0031] FIGURE 15A is a diagram of the uterine wall during pregnancy;

[0032] FIGURE 15B is a diagram of the uterine wall post-partum; and

[0033] FIGURE 16 depicts an exemplary vacuum system with a reservoir.DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0034] The following description of preferred embodiments of the invention is notintended to limit the invention to these preferred embodiments, but rather to enable anyperson skilled in the art to make and use this invention.1. System

[0035] As shown in FIGURE 1, an embodiment of a uterine hemorrhage controllingsystem 100 comprises a suction module 110 including a suction end 120 coupleable to apump 130 by a connecting tube 126, and a sealing module 140 coupled to the suctionmodule 110. The system 100 may further comprise the pump 130 and a filter 150 coupledto the suction module 110. At least a portion of the system 100 is preferably deliveredtransvaginally, and facilitates contraction of the uterus to counteract uterine atony. Thus,the system 100 functions to reduce or entirely stop uterine hemorrhaging, in order tosubstantially reduce total blood lost from the uterus after childbirth. The system 100 mayfurther function to reduce other issues associated with childbirth, including a need for ablood transfusion or a hysterectomy.1.1 System - Suction Module

[0036] The suction module 110 comprises a suction end 120 coupleable to a pump 130by a connecting tube 126, and functions to provide negative pressure (i.e., vacuum)within the uterus to facilitate uterine contraction. Preferably, negative pressure providedby the suction module 110 results in a uniform mechanical stimulus to the uterine wall, inorder to facilitate substantially even contractile movement of tissue; however, the suctionmodule 110 may alternatively be configured to provide a non-uniform mechanicalstimulus to the uterine wall, or to decrease intra-uterine pressure and / or volume by anysuitable method (e.g., mechanically, chemically, creation of a vacuum, reduction inintrauterine temperature). The suction module 110 preferably comprises a distal end 112and a proximal end 113, as shown in FIGURE 1, wherein the distal end 112 comprisesthe suction end 120 and is configured to enter the uterus, and the proximal end 113comprises the pump 130 and is configured to remain external to the uterus. However,both the distal end 112 and the proximal end 113 may be configured to enter the uterus.Preferably, the distal end 112 and the proximal end 113 are coupled by the connectingtube 126 (e.g., by a conduit, tubing, chamber), and may be further configured to bereversibly coupled in variations wherein at least one of the distal end 112 and theproximal end 113 is configured to be disposable. In some variations, the suction module110 may further comprise a pressure sensor and / or a controller, which functions tofacilitate measurement of a pressure provided by the pump 130 and / or a pressure withinthe uterus, and also to controllably adjust a negative pressure provided within the uterus.

[0037] The suction end 120 is configured to be transvaginally delivered, and functions totransmit a negative pressure provided by the pump 130 to the interior of the uterus, whilepreventing tissue or any other substance within the uterus from obstructing the suctionend 120. The suction end 120 is preferably flexible, and may be further configured to bedeformed into one or more configurations. Flexibility in the suction end 120 may furtherfunction to facilitate conformation of the suction end 120 to the intra-uterine anatomy ofthe patient. Variations of a flexible suction end 120 may be configured to be reversibly orirreversibly deformable. Alternatively, the suction end 120 may be rigid and substantiallynon-deformable, or may be configured to be rigid in one environment, and transition to aflexible state in another environment. Preferably, the suction end 120 is composed orpartially composed of a medical-grade material (e.g., polyethylene, polypropylene,stainless steel, cobalt chrome, ceramic), such that the suction end 120 does not induce anadverse reaction after being inserted into a uterus of the patient. The suction end 120 mayfurther be configured to prevent or counteract an inflammatory or biorejection responseby processing the suction end material with anti-inflammatory and / or anti-biorejectionagents (e.g., steroidal or non-steroidal anti-inflammatory agents). However, the suctionend 120 may alternatively be composed of any suitable material that does not prevent thesuction end 120 from transmitting a negative pressure to the interior of the uterus.

[0038] Preferably, at least a portion of the suction end 120 is configured to be disposable,such that the suction module 110 is modular and comprises components that may beremovably attached together. In variations of a modular suction module 110, attachmentlocations between various components are preferably configured to provide hermeticseals, in order to prevent fluid and / or air leakage along the suction module 110. At least aportion of the suction end 120 may alternatively be configured to be reusable, and may ormay not comprise hermetic seals at locations of coupling. In variations wherein a portionof the suction end 120 is configured to be reusable, the suction end 120 preferablycomprises a material that may be sterilized without compromising the function of thesuction end 120. The material may be configured to be sterilized by dry heat sterilization,moist heat sterilization, ethylene oxide sterilization, radiation (e.g., ultraviolet, gamma,electron beam), liquid chemical sterilization, or any other suitable sterilization method. Ina specific example, the material is configured to be sterilized according to the U.S. Foodand Drug Administration 510(k) Sterility Review Guidance K90-1.

[0039] The suction end 120 of the preferred embodiments includes a suction tube 122and a shield 127 coupled to a distal portion of the suction tube 122 configured to enter theuterus. The suction end 120 may, however, omit the shield 127 in other embodiments.The suction tube 122 comprises an opening 123 fluidically coupled to a lumen of theconnecting tube 126, which functions to allow a negative pressure to be transmitted fromthe pump 130, through the connecting tube 126, to the uterus. Preferably, the suction tube122 is flexible, as described above; however, the suction tube 122 may alternatively benon-flexible or undergo a transition from a flexible state to a rigid state in differentenvironments. Additionally, the suction tube 122 may be one of a set of suction tubes 124coupled to the pump 130, such that the suction end 120 has an inherent redundancy ofsuction tubes configured to allow a negative pressure to be transmitted into the uterus.

[0040] Furthermore, the suction tube(s) may comprise a set or plurality of openings 125,the suction tube(s) may be configured to have a curved portion, and / or the suction tube(s)may be configured to have a non-curved portion. Having a plurality of openings 125may, in some embodiments, provide redundancy such that even if some openings 125become plugged with tissue or body fluids, vacuum will still permeate into andthroughout the uterus through the remaining or unplugged openings 125 during use of thesystem 100.

[0041] Additionally, the suction tube(s) 122 may have any suitable length, diameter, orcross-sectional shape (e.g., uniform, non-uniform) configured to facilitate provision of anegative pressure within the uterus.

[0042] In a first variation, the suction end 120 comprises a single suction tube 122 with asingle opening 123. In an example of the first variation, a lumen of the single suction tube122 terminates in the single opening 123 at a distal end of the suction tube 122, and inanother example of the first variation, the single opening 123 is located at any point alongthe length of the suction tube 122. In a second variation, the suction end 120 comprises asingle suction tube 122 with a set of openings 125. In a third variation, the suction end120 comprises a set of suction tubes 124 with a set of openings 125. In other variations,the suction end 120 may have any suitable combination of the above variations, or anysuitable configuration to facilitate provision of a negative pressure within the uterus.

[0043] The shield 127 functions to provide a barrier, in order to prevent obstruction ofthe opening(s) of the suction tube 122 or set of suction tubes 124 by uterine tissue or anyother substance within the uterus. The shield 127 is preferably coupled to a distal portionof the suction tube 122 or set of suction tubes 124 configured to enter the uterus, but maybe coupled to any suitable portion of the suction module 110 or suction tube 122 toprevent obstruction. The shield 127 is preferably composed of a medical-grade material,such as a medical-grade metal or polymer, but may be composed of any suitable materialto prevent obstruction of the opening(s). Additionally, the shield 127 may be rigid orflexible.

[0044] In a first variation, the shield 127' is configured to couple to a portion of a suctiontube 122 and diverge outward from the suction tube 122 at least at a location of anopening 123 to form a perimeter, such that uterine tissue or other tissue is prevented fromimpinging upon the opening 123. In an example of the first variation, the shield 127'comprises a conical or pyramidal surface 128' that flanks a suction tube 122 and that hasan open mouth 129' that extends beyond a distal end of the suction tube 122, as shown inFIGURE 2A. In a second variation, the shield 127" may partially encapsulate an opening123 (e.g., by a cage or a frame) to prevent obstruction of the opening 123. In an exampleof the second variation, as shown in FIGURE 2B, the shield 127" may form a bulbouscage 199" about an opening 123. The dimensions of the bulbous cage are preferablysmaller than the atonic uterus, such that sufficient contraction may be enabled, andsmaller than the vagina opening, such that correct position may be reached. In anotherexample of the second variation, as shown in FIGURE 2C, the shield 127" may form acapsule 198" about an opening, wherein the body of the capsule 198" preventsobstruction of an opening 123 of the suction tube 122, and wherein the capsule has anhole 197" configured to allow the suction tube 122 to facilitate creating of a negativepressure within the uterus. The shield 127 may, however, comprise any suitable geometryand / or configuration to prevent obstruction of the opening(s) of the suction tube 122 orset of suction tubes 124.

[0045] In alternative variations, the suction tube 122 or the set of suction tubes 124 maybe configured to also function as a shield 127 (or to be physically coextensive with theshield). In these alternative variations, the suction tube 122 or the set of suction tubes 124thus functions to simultaneously allow a negative pressure to be applied within the uterus,while preventing obstruction of suction tube opening(s). This dual-functionality may beenabled by strategic placement of the opening(s) 123, 125 of the suction tube(s) 122, 124,and / or by geometrically configuring the suction tube(s) to prevent obstruction of anopening or openings.

[0046] In a first variation of an embodiment wherein the suction tube(s) function as ashield, the suction end 120' may comprise a set of curved suction tubes 124' connected toa connecting tube 126 coupleable to the pump 130, as shown in FIGURE 3A. In anexample of the first variation, the set of curved suction tubes 124' may comprise a firstsuction tube 161 and a second suction tube 162 that are arranged in loops that extenddifferent distances. As shown in the cross sections of FIGURES 3B and 3C, the firstsuction tube 161 and the second suction tube 162 may be coupled to the connecting tube126 by a joint 164. In the example, the first suction tube 161 may have a longer lengthand extend in a wider loop from the distal end 112 of the suction module, and the secondsuction tube 162 may have a shorter length and be configured in a loop that is within theloop created by the first suction tube 161. The first suction tube 161 and the secondsuction tube 162 in the example may have identical or non-identical cross sections (e.g.,dimensions, geometry, lumen configurations), a maximum cross sectional dimensionbetween 25mm and 125mm, and substantially smooth surfaces to prevent abrasion withinthe vagina / uterus. The set of curved suction tubes 124' in the first example is composedof a medical-grade material that is flexible enough to conform to intra-uterine anatomy,but rigid enough to maintain fixed angles at the point of connection between the set ofcurved suction tubes 124' and the connecting tube 126. The medical-grade material in theexample has a Shore A hardness value between 50 and 90. In the example of the firstvariation, the set of curved suction tubes 124' comprises up to eight suction tubes 122'.

[0047] In the example of the first variation, each suction tube 122' in the set of curvedsuction tubes 124' comprises a lumen that is coupled, by the connecting tube 126', to thepump 130, and also connected to a set of openings 125'. A negative pressure provided bythe pump 130 therefore facilitates uterine contraction and allows intra-uterine fluids toflow through a set of openings 125' into the lumen of a suction tube 122'. The set ofopenings 125' in the example are oriented to open along a medial surface of a suctiontube 161,162 to prevent uterine tissue or other tissue from obstructing the set of openings125'. The set of openings 125' in the example comprises openings 123' that are between 1and 6mm in diameter, and are also substantially smooth and rounded, as shown in thecross-section of FIGURE 3D, to prevent damage to the uterus or other tissues.

[0048] In a second variation of an embodiment wherein the suction tube(s) function as ashield 127, the set of suction tubes 124" branch from the connecting tube 126", and atleast one of the set of suction tubes 124" comprises a set of openings 125" along a medialsurface of a suction tube of the set of suction tubes 124". The branched configurationfunctions to prevent tissue from obstructing the medially oriented openings. In anexample of the second variation, as shown in FIGURE 4A, the set of suction tubes 124"comprises openings 123" that are between 1 and 6mm in diameter, and up to 16 suctiontubes with smooth and / or rounded edges to prevent damage to the uterus or other tissues.

[0049] In a third variation of an embodiment wherein the suction tube(s) function as ashield 127, a suction tube 122"' or a set of suction tubes 124"' may comprise a turnaboutportion 163 configured to prevent an opening from being obstructed. In an example of thethird variation, a turnabout portion 163 of a suction tube 122"' may be configured to wraparound itself along a portion of the length of the suction tube 122'", as shown in FIGURE4B. In another example, a set of suction tubes 124'" may comprise a suction tube 122"'with a turnabout portion 163 configured to partially wrap around a length of the set ofsuction tubes 124"'. Alternatively, the turnabout portion 163 may not be configured topartially wrap about a suction tube 122"', but may still provide a shield 127 by providinga barrier to prevent obstruction of an opening.

[0050] Other variations of the suction tube(s) 122, 124, shield 127, and / or dualfunctioningsuction tube(s) may comprise any suitable combination of the abovevariations, an example of which is shown in FIGURE 4C.1.2 System - Sealing Module

[0051] The sealing module 140, which is preferably proximal to the suction end 120 andcomprises a deformable seal 142, functions to provide a seal such that negative pressuremay be maintained within the uterus to facilitate contraction of the uterus. The sealingmodule 140 may be configured to provide a seal at any point from the vulva, the cervix,or any point within the uterus, but preferably provides a seal at a point along the vaginadistal to the uterus. The sealing module 140 may also be configured to be deformable,such that the sealing module 140 has more than one configuration; however, the sealingmodule 140 may be configured to be substantially non-deformable, such that the sealingmodule 140 only has a single configuration.

[0052] Preferably, a complete seal (e.g., airtight / hermetic) is provided by the sealingmodule 140, such that a negative pressure is maintained within the uterus even after thepump 130 is deactivated. In some embodiments, however, a non-complete seal may beprovided by the sealing module 140, such that an adequate negative pressure istransmitted to the uterus while the pump 130 is activated, but the negative pressure is notmaintained after the pump 130 is deactivated. In some embodiments where a completeseal is not maintained, the system 100 may function to provide adequate vacuum to theuterus provided that the leak rate past the sealing module 140 is less than the pump rate ofthe pump 130. Thus, for example, in some embodiments, the pump 130 can provide apump rate that is between 1 L / min - 20 L / min, such as between 10-15 L / min. The pumprate can be on the lower end of the range, for example, when the seal is complete and onthe higher end of the range, for example, when the seal is not complete.

[0053] Alternatively, referring to FIGURE 16, in some embodiments, a pump system1600 can include a manual or intermittent pump 130 with a vacuum reservoir 1661attached thereto. The vacuum reservoir 1661 can, in turn, be connected to a pressureregulator 1663. A separation canister 1664 can be connected both to the pressureregulator 1663 and to tubing 1665 that leads to the suction module (which can be anysuction module described herein). The pump system 1600 in this configuration can beconfigured to maintain a steady vacuum even if pumping with pump 130 is stopped (e.g.,between vacuum pulses). Thus, the pump 130 may be configured to draw a very highvacuum (e.g., substantially higher than the therapeutic 80 mmHg) into the reservoir 1661while the pressure regulator 1663 can be configured to maintain a relatively constantvacuum (e.g., of 80 mmHg) at the suction module. The gauge 1666 connected to thereservoir 1661 can be configured to indicate when the reservoir 1661 needs to be refilled(i.e., by activation of the pump 130). Further, the separation canister 1664 can beconfigured to keep blood from reaching the pressure regulator 1663. In someembodiments, the regulator 1663 can include a display configured to indicate the pressuresupplied to the suction module. In other embodiments, the canister 1664 can include agauge 1667 thereon (e.g., if a fixed (non-display) regulator 1663 is used) to indicate thepressure supplied to the suction module. Advantageously, the system 1660 enables theuse of intermittent (e.g,. manual) pumping, such as in low resource settings withoutaccess to electricity or battery power, while still providing a relatively constant vacuumlevel to the suction module.

[0054] At least a portion of the sealing module 140 may be configured to be disposable,and at least a portion of the sealing module 140 may be configured to be reusable.

[0055] In a first variation, the sealing module 140 is configured to provide a seal withinthe vaginal canal and / or at the cervix. In the first variation, the sealing module 140 maycomprise a seal 141 that is configured to deform, reversibly or irreversibly, into at leasttwo configurations. A first configuration 148 preferably activates the seal, and a secondconfiguration 149 preferably deactivates the seal. Producing the first configuration mayinvolve an expansion (e.g., radial, axial, uniform, non-uniform, isotropic, non-isotropic)of the seal 141, and producing the second configuration 149 may involve a contraction(e.g., radial, axial, uniform, non-uniform, isotropic, non-isotropic) of the seal 141.Producing the first configuration 148 may alternatively involve releasing a constrainedseal 141, and producing the second configuration may involve constraining a releasedseal 141. However, the seal 141 in the first variation may be a non-deformable seal thathas a single configuration.

[0056] In a first specific example of the first variation, as shown in FIGURES 3A and5A, the seal 141' is an inflatable balloon configured to deform into an expandedconfiguration 148' and a contracted configuration 149'. Upon delivering the suction end120 transvaginally, the seal 141' in the first specific example is configured to be situated,in the contracted configuration 149', within the vaginal canal. The seal 141' may then beexpanded to produce an expanded configuration 148' that seals the vagina in order tofacilitate maintenance of a negative pressure within the uterus. In the first specificexample, the seal may be expanded isotropically by delivering a fluid (e.g., saline orwater) or a gas (e.g., air, nitrogen) to the interior of the inflatable balloon from a sourceexternal to the seal through an opening into the inflatable balloon. As shown, the balloonseal 141' in the expanded configuration 148' can have an elongated shape, such as anelongated sphere or spheroid. Alternatively or additionally, the balloon seal 141' mayhave a disk or semi-spherical shape (as shown in Figures 7 and 8A). The expandedconfiguration 148' of the seal in the first specific example substantially fills the entirecross section of the entrance of a woman's postpartum uterus (e.g., the balloon inflates tohave a volumetric capacity up to 300 milliliters, the balloon inflates to have a volumetriccapacity greater than 300 milliliters), and has a diameter between 5 and 14 cm (with amean diameter of approximately 10cm). The inflatable balloon in the first specificexample can also withstand an internal pressure of at least 5 psi, and can be reversed to acontracted configuration 148' upon delivery of the fluid or gas from the interior of theinflatable balloon.

[0057] In the first specific example, the inflatable balloon can be compliant or noncompliant.When compliant, the balloon may conform to the anatomy and provideenhanced comfort for the patient. When noncompliant, the balloon may impose onsurrounding anatomy to create a stronger seal and / or to help the device stay in place.

[0058] In the first specific example, as shown in FIGURES 5A and 5B, the inflatableballoon surrounds the connecting tube 126 coupled to the suction end 120, such that theconnecting tube 126 is isolated from and passes entirely through the inflatable balloon. Aseparate delivery conduit 143, coupleable to a fluid or gas source 144, then transfers a gasor fluid through an opening into the inflatable balloon. The delivery conduit in the firstspecific example is composed of silicon, but may alternatively be composed of any othersuitable material (e.g., rubber, plastic, silicone, silastic, plastic, polyethylene,polyurethane).

[0059] In the first specific example, the seal 141 may alternatively be expanded byproducing a chemical reaction (e.g., mixture of an acid with a base, or any reaction thatproduces a volumetric expansion) within the interior of the sealing balloon. For instance,an acidic solution may be isolated from a chemical base within the sealing balloon, andupon mixture of the acidic solution with the chemical base, a resulting chemical reactionmay produce a controlled, volumetric expansion of the sealing balloon by the productionof a gas within the sealing balloon.

[0060] In a second specific example of the first variation, the seal 141" comprises amembrane 145 and at least one deformable member 146, and is configured to expandradially outward into a first configuration 148" and to contract radially inward into asecond configuration 149" upon manipulation of the deformable member 146. Upondelivering the suction end 120 transvaginally, the seal 141" in the second specificexample is configured to be situated in the second configuration 149", within the vaginalcanal. As shown in FIGURE 6, the deformable member 146 may be configured toproduce an expansion in one, two, or three dimensions (e.g., upon release of acompressed elastically deformable member), and to produce a contraction in one, two, orthree dimensions (e.g., upon compression of an elastically deformable member).Alternatively, the deformable member 146 may be a brace attached to the membrane 145that can outwardly push the membrane 145 into the first configuration 148" and caninwardly pull the membrane 145 into the second configuration 148". In anotheralternative version of the second example, the deformable member 146 may be a shapememorymaterial, such as nitinol, that outwardly pushes the membrane 145 into a firstconfiguration 148" in one environment (e.g., within the body), and inwardly pulls themembrane 145 into a second configuration 148" in another environment (e.g., outside ofthe body).

[0061] In a third specific example of the first variation, the seal 141"' is configured totake on a first geometric configuration 148"' upon an axial deformation of the seal 141'"and to take on a second geometric configuration 149"' in response to a reversedeformation of the seal 141". Upon delivering the suction end 120 transvaginally, the seal141"' in the third specific example is configured to be situated, in the first geometricconfiguration 149'", within the vaginal canal. In the third specific example, the seal 141"'may be structurally configured with a wall that produces a sealing configuration 148"'upon axial deformation and to produce a non-sealing configuration 149"' upon removal ofthe axial deformation, as shown in FIGURE 7. The wall may further comprise ridges orother structures that control deformation into the sealing configuration 148".Alternatively, the seal 141'" may be composed of an incompressible, deformable material,such that axial deformation produces an outward expansion to form the seal, and removalof the axial deformation results in an inward contraction that reverses the seal. In anotheralternative version of the third example, the seal 141"' may comprise a shape-memorymaterial, such as nitinol, that forms a sealing configuration 148"' in one environment(e.g., within the body), and forms a non-sealing configuration 149"' in anotherenvironment (e.g., outside of the body).

[0062] In a fourth specific example of the first variation, the seal 141"" comprises aporous material (e.g., sponge, polymer hydrogel) that is configured to deform into anexpanded configuration 148"" upon absorption of a fluid, and to be in a non-expandedconfiguration 149"" in the absence of a fluid. The porous material may be inserted intothe body in a non-expanded configuration 149"" and may form the expandedconfiguration 148"" of the seal upon absorption of blood, uterine fluids, or any otherfluids. The seal 141"" of the fourth example may thus further function to control bloodloss / hemorrhaging by absorbing blood.

[0063] In a second variation, the sealing module 140 is configured to provide a seal at thevulva in an extracorporeal manner. In an example of the second variation, the sealingmodule 140 comprises a membrane 145 configured to seal the entrance to the vaginaexternal to the body. The membrane 145 has an area larger than the entrance to thevagina, such that an adequate seal may be formed. The sealing module 140 may furthercomprise a sealant (e.g., gel or lubricant) placed between the membrane 145 and thebody, such that a hermetic and airtight seal is formed at the vulva. In this manner, theentrance to the vagina is substantially sealed to allow a negative pressure to be providedwithin the uterus.

[0064] In other variations, the sealing module 140 may only have a single configuration148 configured to produce a seal upon insertion into the body. Prior to insertion, thevagina or vaginal canal may be manually expanded (e.g., with a speculum operated by ahealth care provider), the sealing module 140 may be inserted (with the suction end 120already inserted), and the vagina or vaginal canal may then be released to form a sealabout the sealing module 140. In an example, the sealing module 140 is a substantiallyrigid structure that has a cross section larger than the cross section of the vaginal canal,such that the vaginal canal seals around the rigid structure.

[0065] Additional variations of the sealing module 140 may comprise any suitablecombination of the above variations, or combination of any of the above variations withany other suitable sealing element. Furthermore, in other variations, as shown in FIGURE8A, the connecting tube 126 of the suction module 110 may be coupled to the sealingmodule 140, such that a negative pressure provided by the suction module 110 contractsthe uterus and produces a sealing configuration by the sealing module 140. Additionally,other variations may comprise a sealing module 140 that functions as a shield 127 (or isphysically coextensive with a shield), an example of which is shown in FIGURE 8B.Again, the sealing module may comprise any suitable combination or configuration ofelements as described.

[0066] The sealing modules described herein can be placed in the lower uterus, cervix,vaginal canal or at the outer surface of the body at the vulva to maintain vacuum withinthe uterus. In some embodiments, the device can be configured such that the naturalcollapse of the postpartum tissue in the cervix and vagina creates an adequate seal (i.e.,without the sealing module). Sealing the lower uterus, cervix, vaginal canal, or outersurface of the body can hinder the flow of air into the uterus while vacuum is beingapplied in order to achieve a therapeutic isobaric level of vacuum throughout most if notall of the uterus.1.3 System - Other Elements

[0067] As shown in FIGURE 1, the system 100 may further comprise a pump 130, whichfunctions to generate the negative pressure in order to contract the uterus. The pump maycomprise a clinical (e.g., hospital) suction line, vacuum device, or any appropriate pump(e.g., syringe pump, peristaltic pump) that can produce an adequate negative pressure tocontract the uterus. In a specific example, the pump generates a negative pressure withinthe uterus of up to 3 psi. In one variation, the connecting tube 126 of the suction module110 is configured to couple to the pump 130 in a reversible manner. However, theconnecting tube 126 may also terminate in a pump element in a non-reversible manner,such that the pump 130 is integrated with the system 100. In an example, the pumpelement is a hollow chamber with a naturally expanded configuration. The pump elementin the example may be constrained in a depressed state prior to delivering the suction end120 into the uterus, after which the pump element is released to expand freely. Expansionof the pump element thus generates the negative pressure required to facilitate contractionof the atonic uterus.

[0068] Also shown in FIGURE 1, the system 100 may further comprise a filter 150,which functions to filter fluids and other substances that have entered the connecting tube126. The filter is preferably distal to the pump 130 and proximal to the suction end 120,such that any substance that enters the suction end 120 is filtered prior to reaching thepump 130. Alternatively or additionally, the opening(s) of the suction end 120 maycomprise filters that function to prefilter substances that enter the suction end 120. Thefilter 150 preferably comprises a membrane with pores that prevent passage of unwantedsubstances into the pump.

[0069] As a person skilled in the art will recognize from the previous detailed descriptionand from the figures and claims, modifications and changes can be made to the preferredembodiments of the system without departing from the scope of this invention.2. Method

[0070] As shown in FIGURE 9, a uterine hemorrhage controlling method 200 comprises:shielding a suction module that has been delivered into a uterus S210, sealing an entranceinto the uterus while the suction module is situated within the uterus S220; coupling thesuction module to a pump S230; applying a negative pressure within the uterus uponactivation of the pump S240; and maintaining the negative pressure within the uterus toinduce uterine contraction S250. The method 200 may further comprise delivering thesuction module into the uterus S260; transmitting bodily fluids out of the uterus throughthe suction module S270, and / or filtering the bodily fluids S280.

[0071] Applying vacuum (e.g., a pressure of 40-160 mmHg, such as 50-100 mmHg, suchas 70-90 mmHg, such as approximately 80 mmHg) to a postpartum uterus as describedherein can have the initial effect of removing liquid blood and other fluids, as well aspotentially removing clotted blood, from the uterus while collapsing the uterine wallsonto themselves. The stimulation of the uterine walls with the vacuum and the tissuecontraction that comes from collapsing the uterine walls may facilitate the eventual returnof tone and full contraction of the myometrium, enabling the natural mechanism ofpinching the arterial vessels to physiologically stop bleeding. The method 200 can thusfunction to reduce or entirely stop uterine hemorrhaging, in order to substantially reducetotal blood lost from the uterus after childbirth. The method 200 may further function toreduce other issues associated with childbirth, including a need for a blood transfusion ora hysterectomy. Furthermore, because the method 200 is performed transvaginally, apatient may remain conscious while the method 200 is performed. The method 200 ispreferably performed by the system 100 described above or using the system l00described above; however, the method 200 may be performed by or using any othersuitable system.

[0072] Step S210 recites shielding a suction module that has been delivered into a uterus,and functions to prevent obstruction of a suction module opening, such that a negativepressure may be applied to the interior of the uterus. Preferably, Step S210 is performedusing any suitable variation of the shield and / or dual-functioning suction end describedabove. For example, Step S210 may be implemented using a shield to shield the suctiontube, or may be implemented using a suction tube with medially oriented openings, suchthat the suction tube dually functions as a shield. However, Step S210 may be formedusing any suitable element or method to prevent uterine tissue or any other tissue fromblocking an opening of the suction module.

[0073] Step S220 recites sealing an entrance into the uterus while the suction module issituated within the uterus, and functions to enable maintenance of a negative pressurewithin the uterus. Preferably, Step S220 is performed using any suitable variation of thesealing module described above, an example of which is shown in FIGURE 10; however,Step S220 may be formed using any suitable element or method configured to seal anentrance into the uterus. In a first example, Step S220 comprises expanding an inflatableballoon seal (e.g., by delivering fluid or gas into the balloon) at the entrance to the uterus.In the first example, the inflatable balloon may be inflated near the distal end of thevagina to a pressure of up to 5 psi. In a second example, S220 comprises producing aradial expansion of a membrane seal. In a third example, S220 comprises axiallydeforming a seal to transform the seal into a sealing configuration. In a fourth example,S220 comprises applying a sealant external to the vaginal canal and placing a sealingmembrane at the entrance to the vaginal canal to create a seal. In a fifth example, S220comprises manually expanding the vaginal canal, placing a sealing element into thevaginal canal, and then allowing the vaginal canal to contract about the sealing element tocreate the seal. Other variations of S220 may comprise other manipulations of systemvariations described above, or any other suitable method of sealing an entrance to theuterus.

[0074] Step S230 recites coupling the suction module to a pump, and functions to preparethe suction module to transmit a negative pressure to the interior of the uterus. Step S230may be performed before or after the suction module has been delivered to the interior ofthe uterus. In one variation, Step S230 may comprise coupling a connecting tube of thesuction module to a clinical suction line, as shown in FIGURE 12, but in other variations,Step S230 may alternatively comprise coupling any suitable portion of a suction moduleto any suitable pump element. In some embodiments, for example, the suction model canbe connected directly to the pump without connecting to an intermediate connecting tubeor suction line.

[0075] Step S240 recites applying a negative pressure within the uterus uponactivation of the pump, and functions to generate a stimulus that enables an atonic uterusto contract, thus counteracting uterine atony. The negative pressure may result in auniform mechanical stimulus or a non-uniform mechanical stimulus that results incontraction of the uterus to control hemorrhaging. For instance, the negative pressuremay be a hydrostatic pressure. In an example, the pump is activated to produce a flowrate of less than 30 liters per minute (e.g., between 1 L / min - 20 L / min, such as between10-15 L / min), and a negative pressure of up to 3 psi within the uterus, while monitoringpressure levels using a pressure sensor.

[0076] Step S250 recites maintaining the negative pressure within the uterus toinduce uterine contraction, and functions to facilitate closing of exposed uterine arteriolesin the uterine wall. That is, applying vacuum to the atonic uterus can achieve initialcessation of bleeding by cutting off the blood flow from arteries normally feeding theutero-placental interface. Application of such vacuum to the uterine cavity by use of aseal in the canal leading to the uterus or by relying on the tissues of the canal toeffectively seal around the device can create an essentially isobaric condition within theuterus, affecting all bleeding arteries on the surface of the uterus. Maintenance of thisessentially isobaric condition can help control bleeding until full contraction of theuterine wall occurs naturally. In some embodiments, the vacuum level can be 40-160mmHg. Application of too high of a vacuum level (e.g., above 160mmHg) can interferewith achieving isobaric conditions due to the propensity for tissue to stick to the vacuumports in an occlusive manner thus preventing further distribution of vacuum in the uterus.In some embodiments, a vacuum level within 40-160mmHg can be preset in the system.Step S250 may further function to decrease the possibility of the uterus returning to anatonic state.

[0077] Referring to FIGURES 15A-15B, advantageously, the systems and methodsdescribed herein can control and stop the flow of blood from the utero-placental arteriesby applying vacuum to uniquely remodeled spiral arteries 1551 in the endometrium 1553of the uterine wall 1550, causing them to collapse and thus occlude blood flow bypinching off the arteries 1551. This collapse and occlusion can occur as a result of thevacuum penetrating superficially into the walls of the endometrium 1553, such as by wayof the multitude of arteries 1551 that are causing the bleeding condition. As the conduitsthrough which the vacuum is applied become unable to supply blood and fluids to thesurface 1557 of the uterus, the natural reaction of the superficial tissue and / or uterinemuscle 1559 is to collapse or contract, leading to compression of the walls of the arteries1551 and hence cessation of bleeding. An additional facilitator for creating thiscompressive superficial layer may be the actual apposition of the uterine walls 1550 thathave come together due to the vacuum.

[0078] Macroscopically, the unique remodeling through gestation that enables thismechanism may be the normally spiral arteries 1551 in the endometrium 1553 elongateand remodel to a trumpet shape as the pregnancy progresses. The trumpet shape is uniquein that the diameter of the artery 1551 increases in the direction of flow toward theplacenta 1555, whereas normally, arterial vessels get smaller in diameter in the directionof flow. The trumpet shape of the arteries 1551 has the effect of slowing the bloodvelocity while also dramatically decreasing the pressure relative to the flow upstream ofthe trumpet structure consistent with conventional fluid dynamics. The trumpet shape ofthe arteries 1551 has the key characteristic of providing an increased surface area on theinside of the arteries 1551 in a low flow condition. The vacuum applied to this increasedsurface area at the utero-placental interface 1557 can create a collapsing force on thearteries 1551 due to the induced low pressure applied to the inside of the arteries 1551.Furthermore, the relatively slower blood velocity can make it less likely that bloodflowing from the feeding arteries is able to replenish the blood that is flowing toward thevacuum in the arteries 1551 before collapse of the arteries 1551 causes a circuitous paththrough which the blood can no longer flow leading to occlusion. Maintaining theapplication of isobaric vacuum in the uterus can thus create an omnidirectional cessationof blood flow at every utero-placental interface 1557 until the uterus can eventually attainenough tone to pinch the arteries 1551 as is supposed to naturally occur. This cessationof blood flow can advantageously be used in patients suffering atony and, in someembodiments, in patients suffering disseminated intravascular coagulation (DIC) becausethe control of bleeding at the collapsed trumpet arteries 1551 is not dependent oncoagulation to stop the bleeding.

[0079] The application of vacuum described herein can be slow and intermittent (e.g., viahand pump), fast intermittent (e.g., via diaphragm, piston, peristaltic), or steady-state(e.g., via impeller, multiple pistons). The vacuum acting on the tissue can be such that:(1) the period of any cyclic pulses are faster than the time required for the collapsedvessel to recover to patency (e.g., less than 250mSec); and / or (2) the vacuum within theuterus is maintained at a level that is within 10%, such as within 5%, of a preset vacuumlevel. Maintaining the vacuum in such a way can advantageously prevent oozing orpulsatile release of blood from the arteries and / or uterus.

[0080] Preferably, the negative pressure is maintained until hemorrhaging has beenreduced to safe levels or has substantially stopped. The negative pressure may also bemaintained as long as deemed necessary to maintain the uterine contraction, and in aspecific example, is maintained for between 1 and 24 hours. In an example, maintenanceof a negative pressure of 3 psi within the uterus causes the uterus to fully contract within15 seconds. Additionally, Step S250 may comprise monitoring a patient's blood pressureand heart rate while the negative pressure is maintained, and eliminating the negativepressure after levels have returned to a normal level. In an example, the negative pressuremay be eliminated once the patient's systolic blood pressure is between 90 and 140 mmHg, and the patient's heart rate is between 40 and 100 beats per minute. The negativepressure is preferably eliminated once hemorrhaging has been reduced to safe levels orhas substantially stopped. For example, the negative pressure can be removed after thepostpartum hemorrhaging and / or abnormal postpartum uterine bleeding is controlled forat least 1 hour, until the uterus is firm, and / or until the patient is stable. The negativepressure may be eliminated by removal of a seal to the entrance to the uterus, which maybe performed in any suitable manner (e.g., deflation of an inflatable balloon seal, radialcontraction of a membrane, etc.). In some embodiments, the device can be left in placeeven after hemorrhaging has been reduced (e.g., for up to 24 hours) so as to enable use ofthe device again should atony return. Advantageously, because the suction module has alow profile (e.g., is relatively flat), the suction module can be both less prone to beingejected from the patient with contraction and more comfortable, thereby enablingprolonged residence within the body.

[0081] As shown in FIGURE 11, Step S250 may further comprise Step S255, whichrecites obstructing a connection between the suction module and the pump. Step S255functions to maintain a negative pressure within the uterus, even upon deactivation of thepump. Step S255 also functions to prevent premature elimination of a negative pressurewithin the uterus (e.g., upon deactivation of the pump). Step S255 may further function toallow intrauterine tissue to re-energize, and may further function to facilitate removal ofthe suction module from the uterus. In one variation, Step S255 may comprise clamping aconnecting tube between the suction module and the pump, as shown in FIGURE 11. Inanother variation, the connection may be a valved connection, such that Step S255comprises shutting a valve to obstruct a connection between the suction module and thepump. Step S255 may, however, comprise any suitable variation of obstructing aconnection between the suction module and the pump.

[0082] As shown in FIGURES 9 and 10, the method 200 may further comprise StepS260, which recites delivering the suction module into the uterus. Step S260 functions toinitiate treatment of an atonic uterus. Preferably, Step S260 comprises delivering thesuction end of the suction module described above into the uterus; however, Step S260may comprise delivering any suitable suction module into the uterus. The reverse of StepS260, as shown in FIGURE 11, may comprise removing the suction module from theuterus, and in an example, may comprise clamping a connecting tube to the suctionmodule, deactivating the pump, and then withdrawing the suction module from theuterus. Other variations of Step S260 and the reverse of Step S260 may comprise anyother suitable methods of delivering the suction module into the uterus and removing thesuction module from the uterus.

[0083] As shown in FIGURES 9 and 12, the method 200 may further comprise StepS270, which recites transmitting bodily fluids out of the uterus through the suctionmodule. Step S270 functions to remove fluids from within the uterus in the process ofinducing contraction of an atonic uterus. The bodily fluids preferably pass into at leastone opening of the suction module and into the connecting tube of the suction module;however, Step S270 may alternatively comprise any other means for transmitting bodilyfluids out of the uterus. In some embodiments, the connecting tube and / or portions of thesuction module can be translucent or transparent. Having a translucent or transparentportion can advantageously help visualize the flow as the bodily fluids are removed fromthe uterus. The visualization can enable detection, for example, of fluid flow (e.g., todetermine when hemorrhaging has stopped) and / or of air in the tube (which can indicate aleak of the sealing module). In some embodiments, the visualization of blood flow can beused in conjunction with other physical indicators that bleeding is being controlled (suchas hardening of the uterus due to contraction or palpating the drop of the fundus belowthe umbilicus) to determine the efficacy of the treatment and / or to determine whentreatment is complete.

[0084] Also shown in FIGURES 9 and 12, the method 200 may further comprise StepS270, which recites filtering the bodily fluids. In some embodiments, Step S280 canfunction to remove particles of a particular size and / or to separate liquids and solids fromgas so as to prevent unwanted substances from entering the pump, which allows the pumpto maintain proper function and to continually apply a negative pressure. Step S280 mayfurther function to enable monitoring of blood loss. For example, filtering the bodilyfluids S280 into a transparent container may include collecting the fluid so as to allow acaretaker to monitor a quantity of blood lost during implementation of the method 100.As another example, collecting or filtering the bodily fluids S280 can enable monitoringof blood flow out of the body (e.g., to determine when hemorrhaging has ceased). Asanother example, collecting or filtering the bodily fluids S280 into a container mayenable further use of the bodily fluids (e.g., for reintroduction into the patient'sbloodstream).

[0085] Step S280 may occur at any point along the suction module, distal to the pump;however, Step S280 preferably occurs along a connecting tube coupled to the pump.

[0086] The FIGURES illustrate the architecture, functionality and operation of possibleimplementations of systems and methods according to preferred embodiments, exampleconfigurations, and variations thereof. In this regard, each block in the flowchart or blockdiagrams may represent a module, segment, or step, which comprises one or moreexecutable instructions for implementing the specified logical function(s). It should alsobe noted that, in some alternative implementations, the functions noted in the block canoccur out of the order noted in the FIGURES. For example, two blocks shown insuccession may, in fact, be executed substantially concurrently, or the blocks maysometimes be executed in the reverse order, depending upon the functionality involved.

[0087] The system and method of the embodiments can be embodied and / or implementedat least in part as a machine configured to receive a computer-readable medium storingcomputer-readable instructions. The instructions can be executed by computer-executablecomponents integrated with an application, applet, host, server, network, website,communication service, communication interface, hardware / firmware / software elementsof a user computer or mobile device, or any suitable combination thereof. Other systemsand methods of the embodiments can be embodied and / or implemented at least in part asa machine configured to receive a computer-readable medium storing computer-readableinstructions. The instructions can be executed by computer-executable componentsintegrated by computer-executable components integrated with apparatuses and networksof the type described above. The computer-readable medium can be stored on anysuitable computer readable media such as RAMs, ROMs, flash memory, EEPROMs,optical devices (CD or DVD), hard drives, floppy drives, or any suitable device. Thecomputer-executable component can be a processor but any suitable dedicated hardwaredevice can (alternatively or additionally) execute the instructions.

[0088] A specific example of a uterine hemorrhage controlling system having featuressimilar to those described herein is included below.

[0089] Referring to FIGURES 13A-13B, a uterine hemorrhage controlling system forcontrol and treatment of abnormal postpartum uterine bleeding or hemorrhage caninclude a suction module 1310. The suction module 1310 can be 41 cm long and made ofsilicone. Further, the suction module 1310 can include a curved intrauterine suction loop1324 at the distal end of the suction module 1310. The flat curved suction loop 1324 canadvantageously help ensure that the device is not expelled from the uterus during use.Further, the suction loop 1324 can include a plurality of openings 1325 (e.g., 20 openings1325) oriented towards the inside diameter of the suction loop 1324. The outer surface ofthe suction loop 1324 can be covered by a shield 1327 that overhangs the openings 1325to protect tissue from vacuum and the openings 1325 from plugging with tissue and bloodclots. The suction loop 1324 and shield 1327 can advantageously be atraumatic andconfigured to collapse and / or deform before exerting any forces at the distal tip of theloop 1324. Further, the proximal end of the suction module 1310 can include aconnecting tube 1326 between the loop 1324 and a vacuum connector 1313 forconnection to sterile vacuum tubing. The sealing module 1340 can be filled and emptiedwith a syringe (e.g., a tapered and / or luer syringe) through the seal valve 1331.

[0090] The suction module 1310 (and corresponding system) can be used in patientsexperiencing atony or postpartum hemorrhaging. In some embodiments, the suctionmodule 1310 can be used to treat patients who deliver at over 24 weeks or have a uterusgreater than 24 weeks in size, who do not have an ongoing intrauterine pregnancy, whodo not have an untreated uterine rupture, who do not have an unresolved uterineinversion, and / or who do not have cervical cancer.

[0091] An exemplary method of using the uterine hemorrhage controlling system withsuction module 1310 is described below:1. Evaluate for lacerations, retained products of conception, or other causes ofbleeding prior to using the device.2. Ensure that the bladder is empty in order to facilitate palpation and contractionof the uterus.3. Connect a vacuum canister and sterile standard vacuum tubing to a regulatedvacuum source.4. Use a syringe (e.g., a tapered and / or luer syringe) to remove any air that is inthe sealing module 1340. Ensuring that the sealing module 1340 is depletedof air prior to inserting the suction module 1310 can minimize the risk of airembolism should the sealing module leak and / or burst.5. Fill the sterile syringe with 60 mL of sterile fluid.6. Secure visualization of the cervix to confirm it is dilated ≥ 3 cm to allow forplacement of the suction module 1310.7. Grasp and compress the suction loop 1324 near the distal tip for support andinsert the suction module 1310 transvaginally, leading with the suction loop1324. Use gentle traction on the anterior cervical lip to stabilize the cervicalopening, if needed.8. Place the suction module 1310 such that the suction loop 1324 is located inthe uterus and is oriented in the frontal or coronal plane of the body. In someembodiments, the fixed position of the valve seal 1331 relative to the suctionloop 1324 can be used by the practitioner to determine the orientation of thesuction loop 1324 (e.g., for the design shown in FIGURES 13A-13B, byassuring the seal valve 1331 is oriented at either 6 or 12 o'clock, i.e.,perpendicular to the frontal plane).9. After insertion, confirm that the suction loop 1324 is within the uterus whilethe sealing module 1340 is within the vagina at the external cervical os.Advantageously, this position enables vacuum distal to the sealing module1340 and within the lower uterine segment (LUS) (in contrast to othermechanical means of treating PPH, such as the Bakri balloon device, whichcannot treat the LUS). Ultrasound may be used to confirm proper placementof the suction loop 1324 within the uterus. Because the suction loop 1324 isflat along one plane and curved along the opposite plane, the ultrasound canadvantageously ensure that the loop 1324 is in the desired position.10. In some cases, a B-Lynch compression suture may be used in conjunctionwith the sealing module 1340.11. While securely holding the seal valve 1331 and avoiding unintentionalproximal or distal movement of the sealing module 1340 away from theexternal cervical os, use the sterile syringe to fill the sealing module 1340 with60 mL of sterile fluid. If needed, add up to another 60 mL of sterile fluid toachieve coverage of the external cervical os and create a seal for vacuum.12. Set the vacuum source to 80 mm Hg + / - 10 mm Hg while occluding the end ofthe tubing (80 mm Hg = 1.5 psi = 10.7 kPa = 3.2 in Hg = 106.7 mbar).13. After the vacuum pressure has been set and confirmed, connect the suctionmodule 1310 to the sterile vacuum tubing. Blood flow into the vacuum tubingand / or improvement in uterine tone should be noted after initiation of vacuum.14. The position of the sealing module 1340 at the external cervical os can beconfirmed after the suction module 1310 is in place. If necessary, the suctionmodule 1310 can be repositioned to facilitate a seal. The presence ofintermittent or continuous air flow through suction module 1310 and / or theconnecting tube may indicate an issue with the location or inflation of thesealing module 1340 and can be used to adjust the location or inflation of themodule 1340.15. After initial evacuation of any pooled blood, presentation may vary duringtreatment: there may be no further blood evacuation, or additional bloodmoving into the tubing, or accumulation of blood in the canister. If blood flowdoes not stop or slow sufficiently, consider increasing the vacuum pressure.16. Tape suction module 1310 to the patient's inner thigh without tension to avoidunintentional dislodgement.17. Leave suction module 1310 in place with the vacuum applied until: (1)PPH / abnormal postpartum uterine bleeding is controlled for at least 1 hour,(2) the uterus is firm, and / or (3) the patient is stable.18. Advantageously, repair of vaginal and external genital lacerations can beperformed with the suction module 1310 in place because the sealing module1340 blocks the flow of blood from the uterus. The provider can thereforedetermine if blood originates outside of the sealed volume and, if so, canrepair the vaginal and external genital lacerations without obstruction of theview from blood stemming from the uterus. The sealing module 1340 canallow for confirmation that any repair that is done in the vagina with thesealing module 1340 in place has been a success. Conversely, the lack ofbleeding from the vagina when the sealing module 1340 is in place canconfirm that there are no lacerations in the vagina in need of repair.19. Before disconnecting vacuum, assess the patient to confirm that treatment isno longer needed.20. Disconnect vacuum tubing from the suction module 1310 while vacuum is onto collect any blood from the tubing into the canister. Secure tubing in case reapplicationof vacuum is needed.21. Using a syringe (e.g., tapered and / or luer syringe), remove the fluid from thesealing module 1340 and keep the suction module 1310 in place for at least 30minutes while monitoring for any recurrent uterine bleeding.22. If PPH / abnormal postpartum uterine bleeding remains controlled and theuterus remains firm for at least 30 minutes after vacuum is disconnected,remove the suction module 1310 from the patient. To do so, place one handon the abdomen to secure the uterine fundus while the other hand slowlywithdraws the device.

[0092] A single-arm, literature-controlled, multi-center treatment study was performedwhere each enrolled subject was treated with a uterine hemorrhage controlling systemincluding suction module 1310. The primary endpoint of the study was control ofpostpartum hemorrhage, defined as the avoidance of non-surgical, second line or surgicalintervention to control uterine hemorrhage after the use of the suction module 1310 asdescribed herein. During the study, the following features were evaluated: (1) time tohemorrhage control; (2) rate of non-surgical intervention required to control PPH afteruse; (3) rate of surgical intervention required to control PPH after use; (4) assessment ofdevice usability; and (5) rate of blood product transfusion required after device use, andnumber of transfusion units when administered.

[0093] The comparator to the system with suction module 1310 was a literature metaanalysisof the Bakri Postpartum Balloon. Based on a random effects model used in themeta-analysis, the estimated pooled proportion of subjects who reached control of uterinehemorrhage following Bakri Postpartum Balloon treatments was 82.0% (95% CI:73.4% to 89.2%). By this definition, the study was considered a success if the lowerbound of the two-sided Exact Clopper-Pearson mid-p 95% Confidence Interval for theStudy Treatment Success was greater than or equal to 73.4%.

[0094] A total of 107 subjects were enrolled in the study at 12 investigational centers inthe United States, as shown below in Table 1.Table 1: Subjects in Study

[0095] In Table 1, * indicates all subjects in whom device insertion was attempted, **indicates all subjects in whom treatment was attempted with device (device inserted andvacuum turned on), *** indicates all subjects in whom treatment was attempted withsuction module 1310 (device inserted and vacuum turned on) and whose treatment wasnot aborted early for non-device reasons, and **** indicates all subjects who completedtreatment according to the methods described herein, and who completed their 6-weekvisit without any major protocol or method deviations.

[0096] Referring to Table 2 and Figure 14, the analysis of effectiveness was based on the104 subjects in the mITT Cohort. The 97 subjects in the PP Cohort are also presented.The treatment success rate in the ITT Cohort was 94.3% (100 / 106, p<0.001), with alower bound 95% confidence limit of 88.1%. The treatment success rate of thecomparator, Bakri Postpartum Balloon, was 82.0% (95% CI: 73.4% to 89.2%). Thetreatment success rate in the mITT Cohort is 96.2 (95% CI: 90.4%, 98.9%). The resultsdemonstrate that in the mITT cohort the confidence intervals do not overlap with theBakri Postpartum Balloon comparator.Table 2: Primary Effectiveness

[0097] Control of hemorrhage was defined in the study as the time from connecting thevacuum source to the suction module 1310 to the time the first of any of the followingoccurs: there is no blood being collected in the tubing or canister, or the blood loss isobserved as leveled off in the canister, or blood loss is at a rate of < 500 mL in 24 hours.The median time to control of PPH in both the mITT and PP population was 3 minutes.

[0098] Referring to Table 3, timing of the procedure and duration of treatment wastracked from diagnosis through treatment and patient discharge for subjects enrolled inthe study. The suction module 1310 was used most often within one hour after delivery.Bleeding was controlled quickly from the time of connection of vacuum, with a mediancontrol in three minutes. The duration of treatment with active vacuum connected was amedian of 2 hours and 24 minutes with total in-dwelling time median of 3 hours and 11minutes.Table 3: Duration of Treatment*Timing of steps was available in 100 subjects in whom bleeding was successfullycontrolled with device alone.

[0099] The median hospital length of stay from delivery time was 2.2 days.

[00100] As shown in Table 4, the need for non-surgical intervention after use of thesuction module 1310 was rare, with only 2 subjects receiving non-surgical intervention inthe mITT Cohort. Surgical intervention after treatment with the suction module 1310was reported in three subjects: one subject received a B-Lynch compression suture inconjunction with the device, one subject received B-Lynch compression suture followedby hysterectomy, and one subject underwent hysterectomy.Table 4: Rate of Non-Surgical and Surgical Intervention after Use

[00101] Referring to Table 5, the device usability was notably positive by investigatorson all measurements.Table 5: Investigator Feedback

[00102] In the study, 40 subjects (37.7%) in the ITT Cohort, 38 subjects (36.5%) in themITT Cohort, and 33 subjects (34.0%) in the PP Cohort received any blood productreplacement. Transfusion of four or more units of packed red blood cells (PRBC)occurred in five subjects (4.7%) in the ITT Cohort, five subjects (4.8%) in the mITTCohort, and four subjects (4.1%) in the PP Cohort. No subject developed disseminatedintravascular coagulation (DIC) on the study.

[00103] As shown in Table 6, sub-group analysis of effectiveness rate was evaluatedby mode of delivery, vaginal or c-section. For the ITT population of 106 subjects, therewere 91 vaginal deliveries with three failures, and 15 c-sections with three failures. Thesuccess rates in the ITT Cohort were 96.7% and 80.0% after vaginal and c-section birth,respectively. In the mITT Cohort, success rates were 98.9% and 80.0%, respectively. Inthe PP Cohort, the success rates were 100.0% and 91.7%, respectively.

[00104] Table 6: Effectiveness by Delivery Type / Cohort

[00105] The results of the study demonstrated that the system described herein (e.g.,with module 1310) is safe with an effectiveness rate of 94.3% for its intended use. Theeffectiveness rates in the mITT and PP Cohorts were 96.2% and 99.0%, respectively.There were no adverse events judged definitely related to the device or the procedure, andthere was a low rate of possibly related adverse events, all of which were anticipated inthis patient population and with introduction of an intrauterine device.

[00106] The secondary endpoints were also overwhelmingly positive. Bleeding wascontrolled in 3 minutes in both the mITT and PP populations. The rate of further surgicalor non-surgical intervention after use was very low. The rate of blood transfusion wasexpected in this patient population, treated at U.S. hospitals with ready access to theseresources. The median reported total time for treatment with vacuum in the study was 2hours and 24 minutes, and total in-dwelling time was 3 hours and 11 minutes.

[00107] It should be understood that any feature described herein with respect to oneembodiment can be used in addition to or in place of any feature described with respect toanother embodiment.

[00108] When a feature or element is herein referred to as being "on" another featureor element, it can be directly on the other feature or element or intervening featuresand / or elements may also be present. In contrast, when a feature or element is referred toas being "directly on" another feature or element, there are no intervening features orelements present. It will also be understood that, when a feature or element is referred toas being "connected", "attached" or "coupled" to another feature or element, it can bedirectly connected, attached or coupled to the other feature or element or interveningfeatures or elements may be present. In contrast, when a feature or element is referred toas being "directly connected", "directly attached" or "directly coupled" to another featureor element, there are no intervening features or elements present. Although described orshown with respect to one embodiment, the features and elements so described or showncan apply to other embodiments. It will also be appreciated by those of skill in the art thatreferences to a structure or feature that is disposed "adjacent" another feature may haveportions that overlap or underlie the adjacent feature.

[00109] Terminology used herein is for the purpose of describing particularembodiments only and is not intended to be limiting of the invention. For example, asused herein, the singular forms "a", "an" and "the" are intended to include the pluralforms as well, unless the context clearly indicates otherwise. It will be further understoodthat the terms "comprises" and / or "comprising," when used in this specification, specifythe presence of stated features, steps, operations, elements, and / or components, but do notpreclude the presence or addition of one or more other features, steps, operations,elements, components, and / or groups thereof. As used herein, the term "and / or" includesany and all combinations of one or more of the associated listed items and may beabbreviated as " / ".

[00110] Spatially relative terms, such as "under", "below", "lower", "over", "upper"and the like, may be used herein for ease of description to describe one element orfeature's relationship to another element(s) or feature(s) as illustrated in the figures. Itwill be understood that the spatially relative terms are intended to encompass differentorientations of the device in use or operation in addition to the orientation depicted in thefigures. For example, if a device in the figures is inverted, elements described as "under"or "beneath" other elements or features would then be oriented "over" the other elementsor features. Thus, the exemplary term "under" can encompass both an orientation of overand under. The device may be otherwise oriented (rotated 90 degrees or at otherorientations) and the spatially relative descriptors used herein interpreted accordingly.Similarly, the terms "upwardly", "downwardly", "vertical", "horizontal" and the like areused herein for the purpose of explanation only unless specifically indicated otherwise.

[00111] Although the terms "first" and "second" may be used herein to describevarious features / elements (including steps), these features / elements should not be limitedby these terms, unless the context indicates otherwise. These terms may be used todistinguish one feature / element from another feature / element. Thus, a firstfeature / element discussed below could be termed a second feature / element, and similarly,a second feature / element discussed below could be termed a first feature / element withoutdeparting from the teachings of the present invention.

[00112] Throughout this specification and the claims which follow, unless the contextrequires otherwise, the word "comprise", and variations such as "comprises" and"comprising" means various components can be co-jointly employed in the methods andarticles (e.g., compositions and apparatuses including device and methods). For example,the term "comprising" will be understood to imply the inclusion of any stated elements orsteps but not the exclusion of any other elements or steps.

[00113] As used herein in the specification and claims, including as used in theexamples and unless otherwise expressly specified, all numbers may be read as ifprefaced by the word "about" or "approximately," even if the term does not expresslyappear. The phrase "about" or "approximately" may be used when describing magnitudeand / or position to indicate that the value and / or position described is within a reasonableexpected range of values and / or positions. For example, a numeric value may have avalue that is + / - 0.1% of the stated value (or range of values), + / - 1% of the stated value(or range of values), + / - 2% of the stated value (or range of values), + / - 5% of the statedvalue (or range of values), + / - 10% of the stated value (or range of values), etc. Anynumerical range recited herein is intended to include all sub-ranges subsumed therein.

[00114] Although various illustrative embodiments are described above, any of anumber of changes may be made to various embodiments without departing from thescope of the invention as described by the claims. For example, the order in whichvarious described method steps are performed may often be changed in alternativeembodiments, and in other alternative embodiments one or more method steps may beskipped altogether. Optional features of various device and system embodiments may beincluded in some embodiments and not in others. Therefore, the foregoing description isprovided primarily for exemplary purposes and should not be interpreted to limit thescope of the invention as it is set forth in the claims.

[00115] The examples and illustrations included herein show, by way of illustrationand not of limitation, specific embodiments in which the subject matter may be practiced.As mentioned, other embodiments may be utilized and derived there from, such thatstructural and logical substitutions and changes may be made without departing from thescope of this disclosure. Such embodiments of the inventive subject matter may bereferred to herein individually or collectively by the term "invention" merely forconvenience and without intending to voluntarily limit the scope of this application to anysingle invention or inventive concept, if more than one is, in fact, disclosed. Thus,although specific embodiments have been illustrated and described herein, anyarrangement calculated to achieve the same purpose may be substituted for the specificembodiments shown. This disclosure is intended to cover any and all adaptations orvariations of various embodiments. Combinations of the above embodiments, and otherembodiments not specifically described herein, will be apparent to those of skill in the artupon reviewing the above description.

[00116] As a person skilled in the art will recognize from the previous detaileddescription and from the figures and claims, modifications and changes can be made tothe preferred embodiments of the invention without departing from the scope of thisinvention defined in the following claims.

Claims

1. A method of reducing postpartum bleeding comprising: positioning a device comprising a vacuum element at least partially within a uterus; sealing the uterus with a seal of the device; activating vacuum in the uterus with the vacuum element of the device while the uterus is sealed; and collapsing endometrial trumpet-shaped arteries at an inner surface of the uterus with the vacuum to reduce postpartum bleeding.

2. The method of claim 1, further comprising collapsing the uterus with the vacuum to cause contraction of uterine muscles and reduce postpartum bleeding.

3. The method of claim 1, wherein activating vacuum comprises supplying vacuum from a pump at between 1 L / min and 20 L / min.

4. The method of claim 1, wherein activating vacuum comprises supplying vacuum from a pump at between 10 L / min and 15 L / min.

5. The method of claim 1, wherein activating vacuum comprises producing a pressure of 40-160 mmHg.

6. The method of claim 1, wherein activating vacuum comprises producing a pressure of 50-100 mmHg.

7. The method of claim 1, wherein activating vacuum comprises producing a pressure of 70-90 mmHg.

8. The method of claim 1, wherein sealing the uterus comprises placing the seal in the lower uterus, cervix, vaginal canal, or at the vulva.

9. The method of claim 1, wherein sealing the uterus comprises sealing so as to hinder a flow of air into the uterus while vacuum is applied in order to achieve a therapeutic isobaric level of vacuum throughout the uterus.

10. The method of claim 1, further comprising maintaining an isobaric condition within the uterus after activating vacuum.

11. The method of claim 1, wherein activating vacuum comprises activating with a pump having a vacuum reservoir therein so as to enable a consistent flow of vacuum to the uterus.

12. The method of claim 1, further comprising detecting air in a tube connected to the vacuum element to determine if there is a leak in a seal.

13. The method of claim 1, further comprising visualizing a flow of blood from the uterus through a translucent or transparent tube connected to the vacuum element.

14. The method of claim 1, wherein the steps of positioning, sealing, activating, and collapsing result in stopping postpartum bleeding within 5 hours.

15. The method of claim 1, wherein the steps of positioning, sealing, activating, and collapsing result in stopping postpartum bleeding within 2 hours.

16. The method of claim 1, further comprising confirming that a cervix is dilated to greater than 3 cm prior to the positioning step.

17. The method of claim 1, wherein a leak rate past the seal is less than a pump rate of a pump supplying the vacuum.

18. A method of reducing postpartum bleeding comprising: positioning a device comprising a vacuum element at least partially within a uterus; sealing the uterus with a seal of the device; activating vacuum in the uterus with the vacuum element of the device while the uterus is sealed; collapsing the uterus with the vacuum; and maintaining an isobaric condition within the uterus after activating vacuum to reduce postpartum bleeding.

19. A system configured to treat postpartum hemorrhaging, comprising: a suction module comprising: a vacuum element configured to be placed within a uterus, the vacuum element comprising a plurality of holes therein; and a sealing portion connected to the vacuum element, the sealing portion having a seal configured to seal the uterus; and a pump system configured to connect to the suction module so as to activate vacuum in the uterus through the vacuum element, wherein the pump system comprises: a pump; a vacuum reservoir; and a pressure regulator configured to regulate a pressure between the vacuum reservoir and the suction module so as to maintain a substantially constant vacuum within the uterus.

20. The system of claim 19, wherein the pump is an intermittent pump.

21. The system of claim 19, wherein the pump is a manual pump.

22. The system of claim 19, wherein the pump is configured to draw a vacuum that is higher than a vacuum through the suction module.

23. The system of claim 19, wherein the pump system further comprises a pressure gauge connected to the vacuum reservoir configured to indicate a pressure in the vacuum reservoir.

24. The system of claim 19, wherein the pump system further comprises a separation canister configured to prevent fluids from reaching the pressure regulator.

25. A system configured to treat postpartum hemorrhaging, comprising: a suction module comprising: a vacuum element configured to be placed within a uterus, the vacuum element comprising a plurality of holes therein; and a sealing portion connected to the vacuum element, the sealing portion having a seal configured to seal the uterus; and a connecting tube connected to the suction module, wherein the connecting tube is configured to connect to a vacuum pump so as to activate vacuum in the uterus through the vacuum element, further wherein the connecting tube is transparent or translucent so as to enable viewing of a flow of blood therethrough.

26. A system configured to treat postpartum hemorrhaging, comprising: a suction module comprising: a vacuum element configured to be placed within a uterus, the vacuum element comprising a plurality of holes therein; and a sealing portion connected to the vacuum element, the sealing portion having a seal configured to seal the uterus; and a connecting tube connected to the suction module, wherein the connecting tube is configured to connect to a vacuum pump so as to activate vacuum in the uterus through the vacuum element; wherein the vacuum is configured to collapse endometrial trumpet-shaped arteries at an inner surface of the uterus to reduce postpartum bleeding.

27. The system of claim 19, 25 or 26, wherein the vacuum is configured to collapse the uterus to cause contraction of uterine muscles and reduce postpartum bleeding.

28. The system of claim 19, 25 or 26, wherein the seal is configured to be positioned in the lower uterus, cervix, vaginal canal, or at the vulva.

29. The system of claim 19, 25 or 26, wherein the vacuum element is looped.

30. The system of claim 29, wherein the plurality of holes are positioned along an interior surface of the looped vacuum element.

31. The system of claim 19, 25 or 26, further comprising a shield coupled to and extending along the vacuum element.

32. The system of claim 19, 25 or 26, wherein the vacuum element is atraumatic.

33. The system of claim 19, 25 or 26, wherein the seal is configured to expand from a collapsed configuration to an expanded configuration.