A device operated within the uterus to provide suction for the treatment of uterine bleeding

Abstract

A device for treating uterine bleeding. The actuator is configured to receive an input to deploy an intrauterine portion of the device to assume a larger outer profile within the uterus. The actuator may be coupled to the device body and configured to receive a pulling input, a pushing input, or a twisting input. The intrauterine portion may include flexible opposing members, rotatable tines, segmented hooks, adjustable loops, or compressible foam. The intrauterine portion defines a lumen and a suction port configured to provide suction within the uterus. Markings may be provided on the actuator to indicate the extent to which the intrauterine portion has been deployed within the uterus. An orientation of the actuator may correspond to a direction of deployment of the intrauterine portion. The device may include a valve and an auxiliary suction source configured to provide suction with the device disconnected from the vacuum source.

Description

[Technical field]

[0001] Claiming priority This application claims priority to and all benefits of U.S. Provisional Patent Application No. 63 / 237,611, filed August 27, 2021, the entire contents of which are incorporated herein by reference. [Background technology]

[0002] Excessive bleeding during or after childbirth is a major cause of maternal morbidity. Postpartum hemorrhage is a particularly serious condition in which weak or absent contractions after birth are unable to exert sufficient pressure on bleeding vessels, a phenomenon known as uterine atony.

[0003] It is known to treat postpartum hemorrhage by deploying devices in the uterus. The use of these devices with the application of vacuum can relieve uterine atony by removing excess blood and inducing contractions. Due to the relative size of the uterus and the body opening required to insert the device, there is a need in the art for a vacuum-based device that can be more intuitively inserted and deployed in the uterus to achieve maximum effectiveness. Furthermore, at times it may be necessary to transport a patient with a device in vivo, which may undesirably require the attending medical personnel to disconnect the device from the vacuum source so that treatment is at least temporarily halted. It would be desirable to eliminate or limit such. Further shortcomings in the art that are overcome by the present invention are also disclosed. Summary of the Invention

[0004] The present disclosure is directed to devices, systems, and methods for treating uterine bleeding by application of a vacuum. An intrauterine device is coupled to an end of a suction line that is placed in fluid communication with a vacuum source. The device includes an intrauterine portion configured to be positioned within a uterus. The intrauterine portion can have a shape or outer profile in a deployed configuration that is at least partially complementary to the anatomical dimensions of the uterus. The intrauterine portion can be positioned within the uterus through a body orifice. The intrauterine device can be selectively actuated to change the shape and / or size of the intrauterine portion.

[0005] The intrauterine device includes an intrauterine portion and a device body to which the intrauterine portion is coupled. A vacuum connector is coupled to the device body and configured to be removably coupled with a suction line. The intrauterine portion defines at least one lumen. The intrauterine portion may include opposing members extending from the collar. The opposing members may be coupled to one another to form a loop in the deployed configuration. The opposing members may be resilient to return to an original or natural state in the absence of a force on the device. The loops formed by the opposing members define respective central regions between the distal end and the collar. The central regions may be biased to engage with one another or disposed adjacent to one another in the undeployed configuration. The loops may be initially "closed" in a default setting. An outer profile of the intrauterine portion in the undeployed configuration may be narrower than the collar and / or narrower than the device body.

[0006] The intrauterine portion defines a suction port. The suction port may be located on an inner or outer surface of the opposing member. The suction port is in fluid communication with a lumen defined by the opposing member. The device is configured to be moved from a non-deployed configuration to a deployed configuration to expand an outer profile of the intrauterine portion to capture additional volume within the uterus. Central sections of the opposing members are configured to be spaced apart from one another in the deployed configuration such that suction is provided through the suction port. An actuator is coupled to the intrauterine portion and to the device body. The actuator may be a handle slidably disposed within a hub extending from the device body. The hub may extend radially from the device body in a radial orientation corresponding to a direction of deployment of the intrauterine portion.

[0007] The actuator is configured to receive input from a user to move the intrauterine portion between the undeployed and deployed configurations. The actuator may be a manual actuator in which a handle is shaped to receive a pulling input to retract the distal end of the intrauterine portion proximally, flex the central section outward, and increase the outer profile of the intrauterine portion. The actuator may be movable between a first position and a second position, or at any position therebetween, corresponding to the undeployed and deployed configurations, respectively. The actuator may include a locking feature and indicators. The locking feature is configured to allow the actuator to be selectively locked and released in one of several positions between and including the first and second positions. The indicators may provide information to the user as the extent of deployment. Alternatively, the actuator may be a push actuator or a twist actuator. In another variation, an electronic actuator may be used in which an electronic switch may be activated to operate a motor to deploy the intrauterine portion.

[0008] A baffle may be coupled to the intra-uterine portion. The baffle may be positioned between the opposing members and may extend between the distal end and the collar. The baffle engages the opposing members in the undeployed configuration to occlude the suction port. The baffle is positioned between and spaced apart from central sections of the opposing members in the deployed configuration, thereby opening the suction port to provide suction to the uterus.

[0009] The device includes a cervical seal. The cervical seal may be a bladder configured to be inflated to expand. Alternatively, the cervical seal may include an envelope and a resiliently compressible body within the envelope, the body configured to be compressed to position within the cervical os and then return to a natural state to form a seal. In another variation, opposing axial ends of the cervical seal may be biased toward each other to spread the cervical seal outwardly to form a seal in a manner similar to the intrauterine portion. An actuator may be operably coupled to the cervical seal to simultaneously deploy the cervical seal and the intrauterine portion.

[0010] The device may include an auxiliary suction source coupled to the device body and in fluid communication with the lumen. In one example, the auxiliary suction source is a Jackson-Pratt bulb or drain. The first and second valves may be one-way valves, with the first valve positioned distal to the auxiliary suction source and the second valve disposed proximal to the auxiliary suction source. A vacuum connector may be disposed proximal to the second valve. The resilience of the Jackson-Pratt valve provides suction after release of the manual input, further providing a reservoir in which fluid may be collected. A relief port may be coupled to the device body and positioned distal to the first valve.

[0011] In certain implementations, a twist actuator may be coupled to the device body. The intrauterine portion may include at least two tines. The tines may be formed as loops, each of the tines defining a lumen and a suction port in fluid communication with the lumen. The actuator may include one or more collars, each of the collars coupled to a respective one of the tines. Input to the actuator imparts a corresponding rotation of one or more of the collars, and thus one or more of the tines. The tines may be positioned to lie in a single reference plane in the undeployed configuration, such that in the undeployed configuration, the tines assume a "flattened" profile. The tines may be splayed outwardly of the single reference plane in the deployed configuration.

[0012] In certain implementations, the actuator may be a slider movably coupled to the device body. The actuator may project the intrauterine portion from within the bore of the device. The intrauterine portion may include a plurality of segments formed by a plurality of notches that further define a spine. The spine may define a lumen and may further define a suction port in fluid communication with the lumen. Alternatively, the segments may be separate components pivotally coupled to one another. The intrauterine portion may be a biased or pre-stressed member configured to at least partially bend and / or curl when projected from the bore. When the slider is in a first position, the segments are constrained by the bore in a straight shape. The slider is moved to a second position to expose the intrauterine portion beyond the distal end, after which the segments pivot relative to one another into a hook or other suitable shape.

[0013] In certain implementations, the intrauterine portion is an adjustable loop. The loop defines a lumen and a suction port in fluid communication with the lumen. The loop may include a first opposing member fixedly coupled to the device body and a second opposing member slidably within the device body. The slider is configured to translate relative to the device body to further expose the loop beyond the distal end. In one variation, both the first and second opposing members are slidably within the device body with an actuator coupled to the first and second opposing members. Alternatively, two or more sliders may be coupled to each of the first and second opposing members.

[0014] In certain implementations, the device includes an applicator defining a hole sized to receive the head of the intrauterine portion. The head may be formed from a porous medium, such as a resiliently compressible biocompatible foam. The head may be coupled to an inner tube defining a lumen in fluid communication with the foam. The head is compressible to be fully received within the applicator in the undeployed configuration. An actuator may be operatively coupled to the inner tube. The actuator is configured to receive input from a user to move from a first position to a second position to move the inner tube accordingly and expose the head distally beyond the applicator. The resiliency of the foam increases the outer profile of the head, thereby moving the intrauterine portion to the deployed configuration. The foam is absorbent to draw blood into the head. Additionally, suction may be provided through the head and further suction may be provided through the applicator.

[0015] In certain implementations, the opposing members may each terminate at a respective distal end. The opposing members may define a conduit, with the suction port disposed within the conduit. The opposing members may each include a proximal end coupled to the collar, and a living hinge between the proximal and distal ends to allow the distal section of the opposing member to pivot relative to the proximal section. In a first variation, the opposing members are formed or biased to fully extend. The actuator is actuated to move the device to a non-deployed configuration in which the distal section pivots inwardly about the living hinge to create a narrower outer profile of the intrauterine portion. The input to the actuator may be removed, and the elasticity of the opposing members causes the distal section to pivot outwardly about the living hinge such that the opposing members return to their natural state, thereby moving the device to the deployed configuration. In a second variation, the opposing members are biased to cause the distal section to fold inwardly. The actuator is actuated to pivot the distal section outwardly about the living hinge, thereby moving the device to the deployed configuration. The first and second opposing members can be independently deployable.

[0016] In certain implementations, the actuator can be actuated to selectively permit or prevent suction through one or more suction ports to reduce clogging of the suction ports. The intrauterine portion can include a head defining the suction ports and an inner tube rotatably disposed within the head. The inner tube can define a lumen configured to be disposed in fluid communication with the suction path, and one or more openings in fluid communication with the lumen. The openings are configured to be disposed in selective fluid communication with some, but not all, of the suction ports. Discontinuance of suction through a clogged suction port can result in the clot becoming dislodged.

[0017] In certain implementations, the intra-uterine portion includes a shell defining a volume and an aperture in fluid communication with the volume. The head includes a front portion defining a suction port. The shell is coupled to the head to define the volume, with the suction port opening into the volume. The suction port may be further defined by a funnel extending inwardly from the front portion and a protrusion extending outwardly from the front portion. The shell is configured to provide a first barrier to capture larger thrombi. The funnel and / or the protrusion are configured to provide a second barrier to capture smaller thrombi. [Brief description of the drawings]

[0018] [Figure 1] 1 is a perspective view of a medical waste collection system, the manifold being configured to be removably inserted into the medical waste collection system, the suction line being configured to be removably coupled to the two manifolds, and the intrauterine device being configured to be removably coupled to the suction line. [Figure 2A] FIG. 13 is a perspective view of an implementation of the device, with the intrauterine portion in a non-deployed configuration. [Figure 2B] FIG. 2B is a perspective view of the device of FIG. 2A, with the intrauterine portion in a deployed configuration. [Figure 3A] FIG. 13 is a perspective view of another implementation of the device, with the intrauterine portion in a non-deployed configuration. [Figure 3B] FIG. 3B is a perspective view of the device of FIG. 3A, with the intrauterine portion in a deployed configuration. [Figure 4A] FIG. 13 is an elevational view of another implementation of the device, with the intrauterine portion in an undeployed configuration. [Figure 4B] FIG. 4B is an elevational view of the device of FIG. 4A, with the intrauterine portion in a deployed configuration. [Figure 5A] FIG. 13 is an elevational view of another implementation of the device, with the intrauterine portion in an undeployed configuration. [Figure 5B] FIG. 5B is an elevational view of the device of FIG. 5A, with the intrauterine portion in a deployed configuration. [Figure 6A]FIG. 13 is an elevational view of another device, with the intrauterine portion in a partially deployed configuration. [Figure 6B] FIG. 7B is an elevational view of the device of FIG. 7A, with the intrauterine portion in a deployed configuration. [Figure 7] FIG. 13 is a perspective view of another implementation of the device, with the intrauterine portion in a deployed configuration. [Figure 8A] FIG. 13 is a perspective view of an intrauterine portion of another implementation of the device. [Figure 8B] FIG. 8B is an elevational view of the internal uterine portion of FIG. 8A. [Figure 8C] FIG. 8C is a cross-sectional view of the intrauterine portion of FIGS. 8A-B, with the inner tube in a first rotational orientation relative to the head. [Figure 8D] FIG. 8C is a cross-sectional view of the intrauterine portion of FIGS. 8A-B, with the inner tube in a second rotational orientation relative to the head. [Figure 9] FIG. 13 is a perspective view of an intrauterine portion of another implementation of the device. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0019] The present disclosure is directed to devices, systems, and methods for treating uterine bleeding with a vacuum source. The vacuum source may be accomplished through any suitable means, such as a hospital integrated vacuum system. Another exemplary device is a medical waste collection system 100 sold under the trade name Neptune by Stryker Corporation (Kalamazoo, Michigan), in which a waste container 104 and a vacuum source 106 are supported in a housing 102. The medical waste collection system 100 collects and stores medical waste to be operatively coupled to a docking station through which the medical waste is emptied. At least one reservoir 108 is supported in the housing 102 and may be sized to removably receive a manifold 110 to which at least one suction line 112 is removably coupled. Suitable structures and operation of several subsystems of medical waste collection system 100 are disclosed in commonly owned U.S. Patent Publication No. 2005 / 0171495, published August 4, 2005, International Publication No. WO2007 / 070570, published June 21, 2007, International Publication No. WO2014 / 066337, published May 1, 2014, and International Publication No. WO2017 / 112684, published June 29, 2017, the contents of each of which are incorporated herein by reference in their entirety.

[0020] The intrauterine device 200, 300, 400, 500, 600, 700, 800, 900 is coupled to the end of the suction line 120 opposite the manifold 124 to be placed in fluid communication with the vacuum source 106. The device implementation includes an intrauterine portion configured to be positioned within the uterus, after which blood and other bodily fluids are drawn from within the uterus by the suction provided by the vacuum source 106. Furthermore, the intrauterine portion may have a shape or outer profile in a deployed configuration that is at least partially complementary to the anatomical dimensions of the uterus to maximize the effect of the suction and induce contractions. The intrauterine portion may be positioned within the uterus through a body orifice, particularly a cervical or Caesarean opening. As previously mentioned, it is difficult to use a device that is narrow enough for insertion through a body orifice, yet large enough to secure a significant volume within the uterus. The present disclosure solves the above-mentioned problems by using an intrauterine device implementation that can be selectively actuated to change the shape and / or size of the intrauterine portion. For example, the shape and size of the intrauterine portion may be deployed to engage or conform to the fundus to promote hemostasis.Additional advantages of various implementations of the intrauterine device are also realized.

[0021] 2A and 2B, the intrauterine device 200 includes an intrauterine portion 202 and a device body 203 to which the intrauterine portion 202 is coupled. The device body 203 provides a housing defining an interior through which tubing and other subcomponents of the device 200 may be disposed. A vacuum connector 236 may be coupled to the device body 203 and configured to be removably coupled to the suction line 120 to establish fluid communication between the device 200 and the vacuum source 106. The vacuum connector 236 may be fixedly secured to the device body 203 and define a proximal end of the device 200, or an intermediate tube (not shown) may extend from the device body 203 and include the vacuum connector 236. Other positions of the vacuum connector 236 are contemplated to facilitate line management. The device body 203 is elongated and may function as a handle for manipulating and deploying the device 200 as described below. For example, device body 203 may be cylindrical in shape and have a sufficient length to allow certain features of device 200 to be positioned outside of the vagina (and the patient) so as to be operable by a user. Device body 203 may include contours, geometries, and / or textures disposed along portions of device body 203 to facilitate handling and manipulation of device 200.

[0022] The intrauterine portion 202 may define at least one lumen (not specified). More specifically, the intrauterine portion 202 may include opposing members 210a, 210b extending from a collar 212, one or both of the opposing members 210a, 210b defining a lumen. The opposing members 210a, 210b may be coupled to one another at or near their respective distal ends to define the distal end 211 of the device 200. In such an arrangement, the opposing members 210a, 210b form a loop in the deployed configuration. Although FIGS. 2A and 2B show two opposing members 210a, 210b, three or more opposing members 210a, 210b are contemplated, in which case the opposing members 210a, 210b may be radially deployed in a triangular (three), cross (four), star (five), or other arrangement.

[0023] The opposing members 210a, 210b may be formed from a resilient biocompatible material. The material may be sufficiently flexible to allow bending when the distal end 211 engages tissue, but may be sufficiently resilient to return to an original or natural state in the absence of force on the device 200. The distal end 211 of the device 200 may include a blunt tip to avoid trauma to tissue during insertion and deployment of the device 200. The blunt tip may also be formed from a resilient biocompatible material. The distal end 211, or another portion of the intrauterine portion 202, may be radiopaque or include radiopaque markers to allow visualization under fluoroscopy. In such a case, the device 200 position within the uterus may be visually confirmed and adjusted accordingly, if necessary.

[0024] The intrauterine portion 202, and more particularly the opposing members 210a, 210b, have a length sufficient for the distal end 211 to be positioned adjacent to the fundus with the cervical seal 226 sealing against the cervix. Furthermore, the loops formed by the opposing members 210a, 210b define respective central sections 214a, 214b between the distal end 211 and the collar 212. The central sections 214a, 214b may be biased to engage with each other or disposed adjacent to each other in the undeployed configuration as shown in FIG. 2A. In other words, the central sections 214a, 214b are formed such that the loops are initially "closed" in a default configuration. As a result, the device 200 may be configured such that the intrauterine portion 202 is sufficiently narrow for insertion through a body orifice in the absence of force on the device 200. The outer profile of the intrauterine portion 202 in the undeployed configuration may be narrower than the collar 212 and / or narrower than the device body 203.

[0025] The intrauterine portion 202 defines a suction port 206. The suction port 206 may be disposed on an inner surface of the opposing members 210a, 210b. The suction port 206 may be a linear array of circular holes as shown, although other shapes and configurations may be provided. Other locations of the suction port 206 are additionally or alternatively contemplated (see FIG. 8). The suction port 206 is in fluid communication with the lumen defined by the opposing members 210a, 210b. As a result, the device 200 defines a suction path through the suction port 206, the lumen, and the vacuum connector 236 for drawing blood and other bodily fluids from the uterus to be collected in the medical waste collection system 100.

[0026] Due to the narrow profile of the intrauterine portion 202 in the undeployed configuration, the intrauterine portion 202 can be intuitively inserted through a body opening. In other words, the user does not need to manipulate (e.g., fold a loop) the intrauterine portion 202 to be insertable through a body opening. The device 200 can then be moved from the undeployed configuration to the deployed configuration in order to expand the outer profile of the intrauterine portion 202 to obtain additional volume within the uterus and preferably to contact the fundus to the extent possible. More specifically, the central regions 214a, 214b of the opposing members 210a, 210b are configured to be spaced apart from each other in the deployed configuration such that suction is provided through the suction port 206, as reflected in FIG. 2B. To this end, an actuator 208 is coupled to the intrauterine portion 202 and to the device body 203. The actuator 208 can be a handle 218 slidably disposed within a hub 228 extending from the device body 203. The hub 228 may extend radially from the device body 203 in a radial orientation that corresponds to the direction of deployment of the intrauterine portion 202. In other words, a user may visualize the radial position of the actuator 208 (positioned externally relative to the patient) and determine the direction in which the opposing members 210a, 210b should be deployed within the uterus. For example, Figure 2B generally illustrates the actuator 208 extending laterally from a side of the device body 203, with the intrauterine portion 202 being deployed laterally accordingly.

[0027] The actuator 208 is configured to receive input from a user to move the intrauterine portion 202 between the undeployed and deployed configurations. Figures 2A and 2B show that the actuator 208 is a manual actuator, where the handle 218 is shaped to receive a pulling input to pull the handle 218 outward from within the hub 228. The handle 218 may be coupled to a pull wire (not shown) that extends through the device body 203 and through the collar 212 to be operably coupled to the distal end 211 of the intrauterine portion 202. Movement of the handle 218 retracts the distal end 211 of the intrauterine portion 202 proximally. The flexibility of the opposing members 210a, 210b, particularly the central portions 214a, 214b of the opposing members 210a, 210b, are bent outward to open the loop. The outer profile of the intrauterine portion 202 is larger in size in the deployed configuration than in the undeployed configuration. The outer profile of the intrauterine portion 202 in the deployed configuration may be larger in size than the outer dimensions of the collar 212 and the device body 203. The opposing members 210a, 210b may be formed such that central portions 214a, 214b flare outward to define a pear shape or other suitable shape for the intrauterine portion 202, which may better complement the shape of the uterus.

[0028] The actuator 208 may be movable between or at any position between a first position and a second position corresponding to a non-deployed configuration and a deployed configuration, respectively. In other words, the actuator 208 may be actuated to selectively deploy the intrauterine portion 202 to a desired extent. The desired extent of deployment may be based on the patient's condition or anatomical dimensions, etc. For example, immediately after birth, the size of the uterus may be relatively significant, and therefore it may be desirable to fully deploy the intrauterine portion 202 to contact the fundus and maximize the effect of suction. Once uterine atonics has been successfully treated, the uterus begins to contract, and therefore it is desirable to deploy the intrauterine portion 202 to a smaller extent. To this end, the actuator 208 may include a locking feature 220 and an indicator 222. The locking feature 220 is configured to allow the actuator 208 to be selectively locked and released in one of several positions between the first and second positions. The locking feature 220 may be a switch, a detent, or other suitable mechanism for selectively maintaining the intrauterine portion 202 in a desired extent of deployment. The markings 222 may provide information to the user as a range of deployment. Figure 2B shows the markings 222 and graduated markings on the handle 218 configured to be exposed when the handle 218 is pulled relative to the hub 228. The numbers provided thereon may correspond to the width of the range of deployment of the intrauterine portion 202.

[0029] As an alternative to a pull actuator, the actuator 208 may be a push actuator or a twist actuator. The twist actuator may include a wheel coupled to the device body 203, for example, arranged concentrically around the device body 203. Alternatively, the handle 218 may be rotatable within the hub 228. The pull wire may be operably coupled to the wheel or handle by a mandrel or other suitable mechanism. Twisting of the wheel or handle creates tension in the pull wire to retract the distal end 211 of the intrauterine portion 202 proximally as described. Alternatively, it is contemplated that an electronic actuator may be used in which an electronic switch may be actuated. The switch may be in communication with a motor for tensioning the pull wire to deploy the intrauterine portion 202. Release of the switch may electronically maintain the intrauterine portion 202 in a desired range of deployment. A digital readout may be disposed on the device body 203 to provide a numerical value of the range of deployment of the intrauterine portion 202.

[0030] The baffle 224 may be coupled to the intrauterine portion 202 and configured to regulate suction through the suction port 206 with the intrauterine portion 202 in the undeployed configuration. As best shown in FIG. 2B , the baffle 224 may be positioned between the opposing members 210a, 210b, and more particularly may extend between the distal end 211 and the collar 212. In the undeployed configuration, the baffle 224 engages the opposing members 210a, 210b to occlude the suction port 206. The inner surfaces of the opposing members 210a, 210b engage the opposing sides of the baffle 224 such that suction is not provided through the suction port 206 in the undeployed configuration. Such a feature advantageously provides for the intrauterine portion 202 to be insertable and removable through a body orifice with suction still on (reducing the risk of tissue suction), as opposed to requiring the user to turn off the vacuum source 106 to do so. Thereafter, the intrauterine portion 202 is moved from the undeployed configuration to the deployed configuration such that the baffle 224 is positioned between and spaced apart from the central sections 214a, 214b of the opposing members 210a, 210b, and the suction ports 206 are open to provide suction to the uterus. It is further contemplated that a pull wire of the actuator 208 may be coupled to a proximal end of the baffle 224, in which case the baffle 224 translates within the collar 212 to bend the central sections 214a, 214b of the opposing members 210a, 210b outward. It should be understood that the baffle 224 is optional.

[0031] To ensure maximum effectiveness of suction through the suction port 206 of the intrauterine portion 202 in the deployed configuration, the device 200 includes a cervical seal 226. The cervical seal 226 is a part of the cervical portion 204 that is coupled to the intrauterine portion 202. The cervical portion 204 may also be coupled to the device body 203 and positioned between the device body 203 and the intrauterine portion 202. The cervical portion 204 is configured to be deployed such that the cervical seal 226 seals the cervical os with the intrauterine portion 202 positioned within the uterus. The cervical seal 226 may be a bladder configured to be inflated for expansion. Alternatively, the cervical seal 226 may include an outer envelope and a resiliently compressible body within the outer envelope, the body configured to be compressed for positioning within the cervical os and then return to a natural state to form a seal. In another example, opposing axial ends of the cervical seal 226 may be urged toward one another to spread the cervical seal 226 outwardly to form a seal in a manner similar to that of the intrauterine portion 202. In such an example, the cervical portion 204 may include an additional subcomponent (e.g., a slidable collar adjacent a proximal end of the cervical seal 226) configured to deploy the cervical seal 226. It is contemplated that the actuator 208 may be operably coupled to the cervical seal 226 to simultaneously deploy the cervical seal 226 and the intrauterine portion 202.

[0032] Existing systems may require the attending medical personnel to disconnect the device from the vacuum source during patient transport within a medical facility. Such a fact undesirably stops the treatment. The device 200 of the present disclosure overcomes such shortcomings by providing an auxiliary suction source 230 configured to establish or maintain at least some suction within the uterus during patient transport. In other words, the auxiliary suction source 230 may receive another input from the user to maintain suction through the intrauterine portion 202 when the suction line 112 is disconnected from the vacuum connector 236. The auxiliary suction source 230 may be coupled to the device body 203 and in fluid communication with the lumen. In one example, the auxiliary suction source 230 is a Jackson-Pratt bulb or drain. The Jackson-Pratt valve is a small, lightweight, and low-cost accessory component, and its operation will be familiar to users. The first and second valves 232, 234 may be one-way valves, with the first valve 232 positioned distal to the auxiliary suction source 230 and the second valve 234 disposed proximal to the auxiliary suction source 230. The vacuum connector 236 may be disposed proximal to the second valve 234. Thus, when the suction tube is connected to the vacuum connector 236, suction provided by the vacuum source 106 opens the first and second valves 232, 234. When the suction tube is disconnected from the vacuum connector 236 and an input is provided to the auxiliary suction source 230 (e.g., the Jackson-Pratt valve is squeezed), suction provided by the auxiliary suction source 230 opens the first valve 232, but the second valve 234 remains closed. Blood and other bodily fluids are drawn through the intrauterine portion 202, through the first valve 232, and into the auxiliary suction source 230. More specifically, the elasticity of the Jackson-Pratt valve provides suction and further provides a reservoir in which fluid can be collected. Once the Jackson-Pratt valve has elastically returned to its natural state, presumably at least partially filled with collected fluid, the user may further provide another input to the Jackson-Pratt valve.Due to the one-way nature of the first and second valves 232, 234 and their respective locations relative to the auxiliary suction source 230, positive pressure from squeezing the Jackson-Pratt valve causes the first valve 232 to close and the second valve 234 to open. Fluid is urged proximally through the second valve 234 and the vacuum connector 236 to be collected in a disposable bag that may be removably coupled to the vacuum connector 236 during patient transport. Not only is the Jackson-Pratt valve emptied of fluid, but the input simultaneously primes the auxiliary suction source 230 for additional suction. Once the patient is transported to a desired location, close to the medical waste collection system 100, the disposable collection bag may be disconnected from the vacuum connector 236 and another suction tube coupled to the device 200. The vacuum source 106 may be operated or restarted with little disruption in treatment. A relief port (not identified) may be coupled to the device body 203 and positioned distal to the first valve 232. The relief port is configured to provide a reduction in suction when the suction level exceeds a predetermined threshold.

[0033] 3A and 3B, another implementation of the device 300 is shown in which the intrauterine portion 302 is configured to be actuated by rotation. A twisting actuator may be coupled to the device body (not shown), or alternatively, another type of actuator may be mechanically or electromechanically converted to rotational actuation of the intrauterine portion 302. The intrauterine portion 302 may include at least two tines 310. The illustrated implementation shows three tines 310a, 310b, 310c, although more or less are contemplated. The outer tine 310a is larger than the middle tine 310b, which is larger than the inner tine 310c. The tines 310 are formed as loops, each having a generally straight proximal section that flares outwardly to a generally semicircular distal section. At least the distal end of the outer tine 310a is rounded to provide a blunt end to avoid trauma to tissue during insertion and deployment of the device 300. Other shapes are contemplated to be complementary to the shape of the uterus. Similarly, the tines 310 may be formed with a similar contour as shown, or each of the tines 310 may have a different contour or geometry. The tines 310 may be formed from a resilient biocompatible material to allow for a limited amount of flexing when the device 300 engages tissue.

[0034] Each of the tines 310 defines a lumen and a suction port 306 in fluid communication with the lumen. The lumens of the tines 310 may merge within the device 300, e.g., within the device body, to form a single suction pathway. Alternatively, each of the lumens may remain fluidly separate and valves may be provided within the device 300 configured to independently control suction through each of the tines 310. For example, it may be desirable to provide a lower level of suction through the outer tine 310a because it is positioned closer to tissue within the uterus. In contrast, the inner tine 310c may be operated at a higher level of suction when additional amounts of blood and fluid may accumulate within the uterus. Additionally or alternatively, suction through individual tines 310 may be selectively activated or deactivated based on the patient's condition and other clinical considerations.

[0035] The actuator may include one or more collars 312, 313, 314. Each of the collars 312, 313, 314 is coupled to a respective one of the tines 310a, 310b, 310c. The collars 312, 313, 314 are rotatable relative to one another. To facilitate relative rotation, the device body may include one or more coaxially arranged housings, each coupled to a respective wheel. Rotation of a selected one or more of the wheels imparts corresponding rotation of one or more of the collars 312, 313, 314, and thus one or more of the tines 310a, 310b, 310c. The tines 310 may be rotatable in one direction with a ratchet-like mechanism that prevents rotation in the opposite direction, or the tines 310 may be rotatable in both directions. More specifically, the collars 312, 313, 314 are rotatable about an axis TX from a first orientation (see FIG. 3A) in which the intrauterine portion 302 is in a non-deployed configuration to a second orientation (see FIG. 3B) in which the intrauterine portion 302 is in a deployed configuration. In the non-deployed configuration, the tines 310 may be arranged to lie within a single reference plane 315 such that the tines 310 are arranged in a flat configuration. In the flat configuration, the intrauterine portion 302 may be more easily inserted into and manipulated within the uterus. In the deployed configuration, at least two tines 310 are arranged to be spread outwardly of the single reference plane 315. The spread of the tines 310 outwardly of the single reference plane 315 facilitates the intrauterine portion 302 to assume the uterine volume in three dimensions and / or to contact the uterus in three dimensions. The wheels or another actuator may include a respective locking mechanism to maintain the angular orientation of a corresponding one of the tines 310. The wheels or other actuators may also include markings that correspond to the angular orientation of the tines 310 within the anatomy. It is understood that the device 300 may include a neck portion (e.g., neck portions 204, 404, 504, 604) and additional features of other implementations of the device (e.g., auxiliary suction source 230, etc.).

[0036] 4A and 4B, another implementation of the device 400 is shown, where the intrauterine portion 402 is configured to be actuated by a pushing input. The actuator 408 may be a slider 418 movably coupled to the device body 403. The actuator 408 is configured to receive an input to cause the intrauterine portion 402 to protrude from within a hole 438 in the device 400, as described below. The slider 418 may be movable along a longitudinal axis of the device 400 from a first position (see FIG. 4A) where the intrauterine portion 402 is in a non-deployed configuration to a second position (see FIG. 4B) where the intrauterine portion 402 is in a deployed configuration.

[0037] The intrauterine portion 402 may include a plurality of segments 409. The segments 409 may be formed by a plurality of notches that further define a spine 413. Alternatively, the segments 409 may be separate components that are pivotally connected to one another through a hinge-like joint. The spine 413 may define a lumen 412 and may further define a suction port 406 in fluid communication with the lumen. The intrauterine portion 402 may be a biased or pre-stressed member configured to at least partially bend and / or curl when projected from the hole 438. The biasing may be facilitated by material properties forming the intrauterine portion 402 or with a subordinate component such as an internal stylet formed from a shape memory material. With the slider 418 in the first position, the segments 409 are positioned adjacent to one another and the intrauterine portion 402 is constrained by the straight-shaped hole 438. It is noted that the cervical portion 404 may further define a hole 438 to provide sufficient clearance to accommodate the intrauterine portion 402 in a non-deployed configuration. Additionally, the cervical seal 426 may be deployed sequentially or simultaneously with the deployment of the intrauterine portion 402. When a pushing force is provided to the slider 418 to move it from a first position to a second position, the intrauterine portion 402 is exposed beyond the distal end 411. The intrauterine portion 402 is biased to pivot the segments 409 relative to each other about the back 413 into a hook shape, with the suction port 406 positioned inside the hook shape. It is contemplated that the hook shape need not be generally circular as shown, but may take on another arcuate profile complementary to the shape of the uterus. For example, the biasing member may be formed of a compound that is curved to provide a more complex deployment configuration. In another example, the biasing member may be configured to provide the intrauterine portion 402 with the ability to "double-back" on itself to form a helix of any number of revolutions.

[0038] It should be noted that the slider 418 may be disposed on the same side to which the intrauterine portion 402 is biased. As a result, the user may observe the orientation of the slider 418 and easily understand the direction in which the intrauterine portion 402 should be deployed. Furthermore, the device 400 may include indicia 422 that may include numerical information regarding the angle achieved by the intrauterine portion 402 in the deployed configuration. For example, the indicia 422 in the illustrated implementation may inform the user that the intrauterine portion 402 is deployed approximately 330 degrees. Together with the orientation of the slider 418, the user may determine the shape and position of the intrauterine portion 402 within the uterus.

[0039] 5A and 5B show another implementation of a device 500 in which an intrauterine portion 502 is configured to be actuated by a pushing input. The intrauterine portion 502 includes an adjustable loop 505. The loop 505 may be formed from a resilient biocompatible material, and the distal end of the loop 505 is rounded. Other shapes are contemplated to be complementary to the shape of the uterus. The loop 505 defines a lumen (not specified) and suction ports 506 in fluid communication with the lumen. The suction ports 506 are shown as being evenly spaced apart inside the loop 505, but other positions and arrangements are contemplated as stated.

[0040] The loop 505 may include a first opposing member 510a fixedly coupled to the device body 503, and a second opposing member 510b slidably within the device body 503 (and neck portion 504). The actuator 508 may be a slider 518 operably coupled to the second opposing member 510b. The slider 518 is configured to be translated relative to the device body 503 to expose the loop 505 further beyond the distal end 511. The extent to which the slider 518 is actuated accordingly provides an extent to which the outer profile of the intrauterine portion 502 increases in the deployed configuration. Although FIG. 5B shows the loop 505 remaining generally symmetrical about the longitudinal axis of the device 500 in the deployed configuration, the structure of the loop 505 may be designed to provide off-axis deployment. For example, the loop 505 may be formed from materials or sections of various stiffnesses to assume a desired shape when exposed beyond the distal end. As an alternative to loop 505 as shown, loop 505 may be formed from segments that are pivotally connected by a back portion (see Figures 4A and 4B).

[0041] The device 500 may include a marker 522 disposed on a portion of the loop 505 and positioned so as to be externally observable to the patient as the intrauterine portion 502 is deployed to a deployed configuration. Based on the marker 522, a user may determine the size of the external profile of the intrauterine portion 502 within the uterus. The device 500 further includes a cervical portion 504 and a cervical seal 526 that are deployed as described above. It is contemplated that two or more loops may be provided. In such an arrangement, the actuator 508 may be operably coupled to the loops to deploy them simultaneously and to the same extent, or two or more actuators may be operably coupled to each of the loops to selectively deploy the loops to different extents.

[0042] In one variation, both the first and second opposing members 510a, 510b are slidably within the device body 503 with an actuator 508 coupled to the first and second opposing members 510a, 510b. Alternatively, two or more sliders 518 may be coupled to each of the first and second opposing members 510a, 510b. In such a variation, each of the sliders 518 may be selectively adjusted by the same or different amounts to selectively adjust the resulting shape of the loop 505. For example, a user may push one slider 518 and pull the other slider 518 to provide asymmetric deployment of the intrauterine portion 502 within the uterus. Such functionality may be particularly advantageous in clinical scenarios where localized bleeding is identified on one side of the uterus.

[0043] 6A and 6B, another implementation of a device 600 configured for actuation of the intra-uterine portion 402 by a pushing input is shown. The device 600 includes an applicator 637 that defines a hole 638 sized to receive the head 601 of the intra-uterine portion 602. The head 601 may be formed from a porous medium, such as a resiliently compressible biocompatible foam. The head 601 may be coupled to an inner tube 646 that defines a lumen in fluid communication with the foam. The head 601 is compressible to be fully received within the applicator 637 in a non-deployed configuration. The applicator 637 has an outer diameter that is sufficiently narrow to aid in insertion of the device 600 through a body orifice. An actuator (not shown), such as the slider described above, may be operably coupled to the inner tube 646. The actuator is configured to receive input from a user to move from a first position to a second position, and accordingly move the inner tube 646 and the head 601 distally relative to the applicator 637. When the head 601 is exposed beyond the distal end 611 of the applicator 637, the resilience of the foam increases the outer profile of the head 601, thereby moving the intrauterine portion 602 to the deployed configuration. Although FIG. 6B shows the head 601 as assuming a pear shape complementary to the shape of the uterus, the head 601 may be designed to assume other suitable shapes. In particular, due to the compressibility and manufacturability of the foam, highly eccentric and irregular shapes may be achieved. For example, the distal section of the head 601 may be more than twice as wide in the deployed configuration as the proximal section. In another example, the proximal section may be wider than the distal section in the deployed configuration in clinical cases that may be shown to absorb blood pools near the cervix. It is also contemplated that reinforcing elements and other structures may be bonded to or embedded in the foam to cause the deployment of a desired shape.

[0044] In the deployed configuration, the foam is absorbent to draw blood into the head 601. Additionally, the foam may be formed with a density that allows suction through the head 601. Additional suction may be configured to be provided through the applicator 637, which may be particularly advantageous since the distal end 611 of the applicator 637 is positioned just distal to the neck where blood tends to accumulate. It should be understood that this implementation of the device 600 may include a neck portion, an auxiliary suction source, and other features of other implementations described herein.

[0045] 7 shows another implementation of a device 700 in which the intrauterine portion 702 is configured to be actuated by a pulling or pushing input. The intrauterine portion 702 may include first and second opposing members 710a, 710b, each terminating at a respective distal end, unlike loops. The first and second opposing members 710a, 710b may be considered tines. It should be understood that there may be more than two tines arranged in any suitable radial orientation. For example, the tines may be equiangularly spaced radially relative to the collar 712, or may be irregularly spaced to provide a localized concentration of tines located in areas of the uterus that are likely to experience excessive bleeding.

[0046] The first and second opposing members 710a, 710b each include a proximal end coupled to a collar 712 and a living hinge 740a, 740b between the proximal and distal ends. The living hinges 740a, 740b are configured to allow the distal section of the opposing member 710 to pivot relative to the proximal section. In other words, the opposing member 710 may be "foldable." The distal section may be arcuate and flared outward to form an outer profile of the intrauterine portion 702 that is at least partially complementary to the uterus.

[0047] In one variation, the opposing member 710 is formed or biased to be fully extended as shown in FIG. 7. The opposing member 710 may be formed from a resilient biocompatible material. A distal section of the opposing member 710 (i.e., distal to the living hinge 740) is operably coupled to an actuator (not specified), for example, via a pull wire. The actuator is actuated to move the device 700 to a non-deployed configuration in which the distal section pivots inwardly about the living hinge 740 resulting in a narrower outer profile of the intrauterine portion 702. An input force may be maintained on the actuator as the intrauterine portion 702 is inserted into the uterus through a body opening. Once positioned as desired, the input force to the actuator may be removed and the resiliency of the opposing member 710 causes the distal section to pivot outwardly about the living hinge 740 such that the opposing members 710 return to their natural state, thereby moving the device 700 to the deployed configuration.

[0048] In another variation, the opposing members 710 are biased such that the distal section folds inward. The device 700 is in an undeployed configuration and is insertable through a body orifice. The actuator is actuated to pivot the distal section outward about the living hinge 740, thereby moving the device 700 to the deployed configuration. For example, a reinforcing element may be slidably positioned within a hole extending through each of the opposing members 710. A pushing force on the actuator urges the reinforcing element distally within the hole to straighten the opposing members 710. In any variation, it is contemplated that the first and second opposing members 710a, 710b may be independently deployable. Two or more actuators may be provided, each coupled to a respective one of the first and second opposing members 710a, 710b.

[0049] The opposing member 710 defines a suction port 706. In this implementation, the opposing member 710 defines a conduit 742, and the suction port 706 is disposed within the conduit. Positioning of the suction port 706 within the conduit 742 is desirable when the suction port 706 is on the outer surface of the device 700, such as that shown in FIG. 7. In other words, the outer surface of the opposing member 710 is more likely to contact uterine tissue and thus be susceptible to tissue suction by the suction port 706 on the outer surface that would otherwise be susceptible. Thus, the conduit 742 provides a gap or clearance that may limit instances of tissue suction. Additionally or alternatively, the suction port 706 may be disposed on an inner surface of the opposing member 710. The suction ports 706 may be equally spaced apart, or more or fewer suction ports may be disposed in the distal or proximal sections. The opposing member 710 further defines a lumen in fluid communication with the suction port 706. The lumens may be joined within device 700 to form a single suction pathway, or each of the lumens may remain fluidly separate, with device 700 configured to independently control suction through each of the opposing members 710. It should be further understood that this implementation of device 600 may include a neck portion, an auxiliary suction source, and other features of other implementations described herein.

[0050] The sequelae of postpartum hemorrhage may include the formation of blood clots within the uterus. The blood clots may be of sufficient size to occlude or clog one or more of the suction ports, thereby compromising the effectiveness of suction. The actuation-based functionality of the presently disclosed devices may be realized for active clog management. One embodiment of a device 800 is shown in Figures 8A-8D in which an actuator (not identified) is actuated to selectively permit or prevent aspiration through one or more suction ports 806. The intrauterine portion 802 includes a head 844 that defines the suction port 806, and an inner tube 846 that is rotatably disposed within the head 844. The head 844 includes a flange 845 that defines a conduit, and the suction port 806 is disposed within the conduit for reasons already described. Although the illustrated implementation shows the intrauterine portion 802 as elongated having a generally constant cross-section, the head 844, such as a body or flange 845, may flare outwardly or be of any suitable contour to provide a variety of cross-sectional profiles to the intrauterine portion 802. Similarly, the suction ports 806 may be positioned on any of the surfaces of the head 844 and in any suitable arrangement.

[0051] The inner tube 846 may define a lumen configured to be placed in fluid communication with the suction pathway. The inner tube 846 may define one or more openings 848 in fluid communication with the lumen. With the inner tube 846 rotatable within the head 844, the openings 848 are configured to be selectively placed in fluid communication with the suction ports 806. For example, FIG. 8C shows that with one of the openings 848 aligned with the upper one (row) of the suction ports 806, the suction port 806 is radially blocked on the opposite side of the head 844. Suction within the uterus may be established through this alignment, and suction through the other two suction ports 806 may be prevented. A blood clot (C) may clog the suction port 806, and a measured drop in suction, as measured on the medical waste collection system 100, may be interpreted as a clogging of the suction port 806.

[0052] As a result, a user can provide an input to an actuator (not identified) to rotate the inner tube 846 within the head 844. As shown in FIG. 8D, the relative rotation moves the opening 848 into alignment with another of the suction ports 806. This alignment re-establishes suction through the unblocked one of the suction ports 806 and prevents suction through the blocked one of the suction ports 806. In addition to maintaining a desired level and effect of suction within the uterus, interruption of suction through the blocked suction port can result in the clot being dislodged. The previously blocked suction port 806 can be reopened for subsequent use if desired.

[0053] It should be understood that the inner tube 846 may include more than one opening 848. For example, the inner tube 846 may include two openings on opposing sides configured to align with the suction ports 806 on opposing sides of the head 844. In another example, the inner tube 846 may include an equal number of openings and may be configured to align with all of the suction ports 806 on the head 844. In such an example, rotation of the inner tube 846 within the head 844 is configured to selectively activate or deactivate suction through the head 844 through input to an actuator. It is further contemplated that the active clog management of this implementation may be realized in any other of the implementations described herein. For example, the inner tube defining the openings may be disposed within various opposing members (e.g., loops, tines, etc.) described herein and operably coupled to additional actuators. Input to those actuators may rotate the inner tube within the opposing members to selectively prevent suction through one or more of the suction ports that may be clogged.

[0054] Another implementation and its effect on reducing clogging is shown in FIG. 9. The intrauterine portion 902 may include a shell 956 that defines a volume, and an aperture 958 in fluid communication with the volume. The head 905 includes a front portion 907 that defines a suction port 906. The shell 956 is coupled to the head 905 to define a volume, with the suction port 906 opening into the volume. The suction port 906 may be further defined by a funnel 952 extending inwardly from the front portion, and a protrusion 954 extending outwardly from the front portion 907.

[0055] The shell 956 is configured to provide a first barrier to capture thrombus above a first size. As shown in FIG. 9, the thrombus is captured by one of the holes 958 of the shell 956, while suction through the remaining holes 958 remains unimpeded. In other words, suction remains unimpeded through other holes 958 radially disposed around the shell 956. It is also noted that the holes 958 are elongated in size and therefore less likely to be occluded by the thrombus, which may be generally spherical in shape. If the thrombus is small enough to pass into the volume through one of the holes 958, the funnel 952 and / or the protrusion 954 are configured to provide a second barrier to limit the reduction in the effectiveness of the suction. For example, the funnel 952 may cause the thrombus to at least partially collect within the funnel 952, thereby preventing the thrombus from clogging the multiple suction ports. Similarly, the protrusion 954 may guide thrombus toward the funnel 952. Additionally, suction ports 906 defined through the protrusion 954, for example, at the distal end of the frustum, may reduce the likelihood that thrombus will be located at the distal end of the frustum. Figure 8 may be considered a form of active clog management, while Figure 9 may be a form of passive clog management.

[0056] Several configurations have been discussed in the foregoing description. However, the configurations discussed herein are not intended to be exhaustive or to limit the invention to any particular form. The terminology used is intended to be in the nature of words of description rather than of limitation. Many modifications and variations are possible in light of the above teachings, and the invention may be practiced otherwise than as specifically described.

Claims

1. 1. A device for treating intrauterine bleeding, comprising: a device body including a vacuum connector configured to be removably coupled to a suction tube; an intrauterine portion coupled to the device body and defining an internal lumen and a suction port in fluid communication with the internal lumen, the intrauterine portion having an outer profile in an undeployed configuration sized and shaped to be guided through a body orifice and positioned within the uterus; an actuator coupled to the device body and configured to receive an input such that the outer profile of the intrauterine portion expands to a deployed configuration that increases in size within the uterus; A device comprising:

2. 2. The device of claim 1, wherein the intrauterine portion comprises opposing members coupled to the actuator and defining the suction port, the opposing members being biased adjacent to one another in the undeployed configuration and configured to move away from one another in the deployed configuration based on the input to the actuator.

3. The device of claim 2 , wherein the opposing members are coupled to one another to form a loop in the deployed configuration.

4. 3. The device of claim 2, wherein the intrauterine portion further comprises a collar to which the opposing members are coupled, and a baffle coupled to the collar, the baffle being positioned between the opposing members and configured to occlude the suction port in the undeployed configuration.

5. 2. The device of claim 1, wherein the intrauterine portion comprises at least two tines, each coupled to the actuator and defining the suction port, the tines being configured to be rotated relative to one another such that the tines spread outwardly of a single reference plane in the deployed configuration based on the input to the actuator.

6. 10. The device of claim 1, wherein the intrauterine portion comprises a prestressed member coupled to the actuator and defining the suction port, the prestressed member configured to protrude from the device body and assume a hook shape in the deployed configuration based on the input to the actuator.

7. The device of claim 6 , wherein the prestressed member comprises segments joined together by a spine, the spine defining the suction port.

8. 2. The device of claim 1, wherein the intrauterine portion comprises an adjustable loop having a first end fixedly coupled to the device body and a second end coupled to the actuator such that the adjustable loop extends from the device body in the deployed configuration based on the input to the actuator.

9. 10. The device of claim 1, wherein the intrauterine portion comprises an applicator, a head formed from compressible foam, and an inner tube coupled to the head and the actuator, the head configured to resiliently expand when extended from the applicator based on the input to the actuator.

10. 2. The device of claim 1, wherein the intrauterine portion comprises opposing members coupled to the actuator and defining the suction port, each of the opposing members comprising a living hinge, the distal section of each of the opposing members being configured to pivot about the living hinge relative to the proximal section based on the input to the actuator.

11. The device of claim 1 , wherein the actuator comprises a slider or handle movably coupled to the device body, or a wheel rotatably coupled to the device body.

12. The device of claim 1 , wherein the intrauterine portion further defines a conduit, and the suction port is disposed within the conduit.

13. an auxiliary suction source coupled to the device body; a first valve positioned distal to the auxiliary suction source; a second valve positioned proximal to the auxiliary suction source; and The device of claim 1 , further comprising:

14. The device of claim 13 , wherein the vacuum connector is positioned proximal to the second valve.

15. 14. The device of claim 13, wherein the auxiliary suction source is a valve configured to receive an input, the resilience of the valve creating a vacuum and defining a reservoir for collecting bodily fluid.

16. The device described in claim 13, further comprising a relief port coupled to the device body and positioned distal to the first valve.

17. the actuator is configured to be moved between a first position in which the intrauterine portion is in the undeployed configuration and a second position in which the intrauterine portion is in the deployed configuration, and to be positionable between the first and second positions to selectively establish an extent of deployment of the intrauterine portion; The device of claim 1 , wherein the actuator comprises markings configured to be exposed to provide information regarding the extent of deployment of the intrauterine portion.

18. 10. The device of claim 1, wherein the intrauterine portion further comprises an inner tube disposed within the lumen and defining an opening, the inner tube configured to be rotated within the lumen to selectively align the opening with some but not all of the suction ports to provide active clog management.

19. 1. A device for treating intrauterine bleeding, comprising: a device body including a vacuum connector configured to be removably coupled to a suction tube; an intrauterine portion defining an internal lumen configured to be placed in fluid communication with a vacuum source and a suction port in fluid communication with the internal lumen, the intrauterine portion comprising a baffle configured to form a loop in a deployed configuration and configured to engage and occlude the suction port in an undeployed configuration; an actuator coupled to the device body and configured to receive input from a user to move the intrauterine portion from the undeployed configuration to the deployed configuration in which an outer profile of the intrauterine portion is increased; A device comprising:

20. 20. The device of claim 19, further comprising a collar to which the loop is coupled, the baffle being coupled to the collar and to a distal end of the loop.

21. 21. The device of claim 20, wherein the actuator is coupled to the baffle, the baffle configured to translate within the device body to retract the distal end of the loop proximally.

22. 1. A device for treating intrauterine bleeding, comprising: a device body including a vacuum connector configured to be removably coupled to a suction tube; an intrauterine portion defining an internal lumen configured to be placed in fluid communication with a vacuum source and a suction port in fluid communication with the internal lumen; a neck portion configured to seal the neck; an actuator coupled to the device body and configured to receive input from a user to move the intrauterine portion from an undeployed configuration to a deployed configuration in which an outer profile of the intrauterine portion is increased; an auxiliary suction source disposed proximal to the neck portion and configured to receive manual input from a user to establish or maintain a vacuum in the absence of a vacuum connector coupled to the vacuum source; A device comprising:

23. a first valve positioned distal to the auxiliary suction source; a second valve positioned proximal to the auxiliary suction source; and Furthermore, 23. The device of claim 22, wherein the vacuum connector is coupled proximally to the second valve.

24. 23. The device of claim 22, wherein the auxiliary suction source is a valve configured to receive an input, the resilience of the valve creating a vacuum and defining a reservoir for collecting bodily fluid.

25. 25. The device of any one of claims 22 to 24, further comprising a relief port coupled to the device body and positioned distal to the first valve.

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