Systems and methods for providing tamponade and suction based therapy to the uterus - Patents.com

Abstract

A system and method for treating a uterus. The system provides separate and / or simultaneous tamponade and suction based therapy. The device includes an intrauterine portion coupled to or integral with the cervical portion. An inner bag can be disposed within the outer body, and the inner bag can be configured to receive and expand fluid. The outer body defines a suction opening, and the patient's bodily fluids can be aspirated through a volume defined between the inner bag and the outer body. The device can include one or more spacer mechanisms or struts to maintain the volume. A distal cap can aid in distal expansion of the intrauterine portion to engage the fundus. The cervical portion can be deployed into an expanded configuration within the cervix. The system can include a conduit defining at least three fluid paths, a connector, and a control hub configured to be coupled to the conduit or to the device via the connector.

Description

[Technical field]

[0001] The present invention relates to a system and method for providing tamponade and suction based therapy to the uterus.

[0002] [Priority claim] This application claims priority to and the benefit of all of U.S. Provisional Patent Application No. 63 / 448,084, filed February 24, 2023, and U.S. Provisional Patent Application No. 63 / 323,677, filed March 25, 2022, the entire contents of each of which are incorporated by reference herein. [Background technology]

[0003] Excessive bleeding during or after childbirth is a major cause of maternal morbidity. Postpartum hemorrhage (PPH) is a particularly serious condition in which weak or absent contractions after birth are unable to exert sufficient pressure on blood vessels, a phenomenon known as uterine atony.

[0004] It is known to treat PPH by deploying a balloon within the uterus to provide tamponade. Pressure exerted by the deployed balloon against the uterine wall promotes hemostasis. Alternatively, it has been shown that application of suction within the uterus can induce uterine contractions, which in many cases promote hemostasis. Due to the fundamental differences in the aforementioned techniques, devices configured to provide tamponade may not provide optimal suction, and devices configured to provide suction are disadvantageous when designed to provide tamponade. Summary of the Invention [Problem to be solved by the invention]

[0005] Thus, there is a need in the art for a device that provides for the selective delivery of tamponade-based therapy and / or suction-based therapy. There is a further need in the art for such a device that can be easily positioned within the uterus through the cervix or through a cesarean section for intuitive deployment and operation. [Means for solving the problem]

[0006] A system for treating a uterus includes a device and an optional control hub coupled to the device by a conduit. The device may be removably coupled to the control hub by a connector. The device provides tamponade and suction based therapy within the uterus, separately or simultaneously, each at variable and / or adjustable levels. The device includes an intrauterine portion and a cervical portion coupled to the intrauterine portion. The cervical portion is optional.

[0007] The device includes a bladder coupled to a conduit. The conduit defines a suction pathway and an inflation pathway separate from the suction pathway. At least one suction port defined by the conduit is in fluid communication with the suction pathway. The bladder defines a first volume in fluid communication with the inflation pathway. The suction port is located exterior to the bladder. The suction port can be located proximal to where a base of the bladder is coupled to the conduit. Another suction port or ports can be defined by the conduit distal to the bladder.

[0008] The device may include an expandable outer body disposed to at least partially cover the inner bag. A portion or the entirety of the inner bag may be disposed within the outer body. A second volume is defined between the inner bag and the outer body. The second volume and the first volume may not be in fluid communication with each other. The second volume is in fluid communication with the suction port and the suction path of the conduit. The outer body defines a plurality of suction openings in fluid communication with the second volume. The outer body may define at least one recess, within which the plurality of suction openings are disposed. The plurality of suction openings may be of any suitable size or sizes and shape or shapes, and / or may be disposed at any suitable spacing, location, etc., and combinations thereof.

[0009] The second volume can be maintained by a number of protrusions or other spacing features on the outer surface of the inner bag and / or on the inner surface of the outer body. The spacer features can be integrally formed with the inner bag and / or the outer body, or can be separate components. In certain implementations, the separate components can be one or more struts. The struts can be located between the inner bag and the outer body. The struts can be elongated and can include a number of protrusions that define a channel that provides at least a portion of the second volume. The struts define a number of holes disposed within the channel. The strut holes are aligned with the suction openings of the outer body. There can be more than three struts, or less than three struts, and the struts can be oriented longitudinally, circumferentially, a combination thereof, or in other suitable configurations. A face of the strut is disposed opposite the protrusion and is fixedly coupled to the inner surface of the outer body. In other variations, the struts may be fixedly coupled to the outer surface of the inner pouch, may be free floating, may be fixedly coupled to another subcomponent of the device, or a combination thereof. The struts may include flared portions near their respective distal ends that flare inwardly toward the conduit. The struts may be used in combination with suction openings defined within recesses in the outer body.

[0010] The conduit defines an inflation port in fluid communication with the inflation pathway. The inner bag can expand in all directions, and the outer body can constrain the expansion of the inner bag to provide a desired expansion profile to the intrauterine portion. Alternatively, the inner bag can be formed from a flexible, inelastic material that is rolled or folded within the outer body. The outer body can stretch and otherwise conform to the shape of the inner bag. Multiple inner bags can be disposed within one or more outer bodies, each configured to be separately, adjustably deployed to provide a desired expansion profile to the intrauterine portion.

[0011] The intrauterine portion can expand radially outward as well as longitudinally outward, i.e., axially distally. The device can include a distal cap movably arranged to cover the distal end of the conduit. The distal end can include a base fixedly coupled to a proximal portion of the conduit. The base can seal the distal end of each of the conduit's multiple lumens or passages. The distal end can taper inwardly from the base. The distal cap defines a cavity sized to receive the distal end. The body of the distal cap can define the cavity and the cap head can include a blunt tip. The inner bag is coupled to the distal cap, and in particular a tip portion of the inner bag can be coupled to the cap head of the distal cap. The outer body need not be directly coupled to the distal cap. The base of the inner bag is fixedly coupled to the conduit and the tip portion of the inner bag is fixedly coupled to the distal cap. For example, in implementations in which the inner bag is formed from a flexible, inelastic material, the distal cap is optional.

[0012] In certain implementations, a collar can connect the intrauterine portion and the cervical portion. Alternatively, the intrauterine portion and the cervical portion can be formed as a unitary component. In another variation, the collar can be formed with the intrauterine portion and the cervical portion formed as a unitary component. The collar is coupled to the conduit and includes an inner hub, an outer hub, and a barrier connecting the inner hub and the outer hub. The barrier can extend radially outward from the inner hub to the outer hub. The inner hub can be located proximal to the barrier and the outer hub can define a cavity distal to the barrier. The cavity is in fluid communication with the second volume and the suction port can be axially located within the cavity. A base of the outer body is coupled to the collar. The outer hub can include an outer flange and a base of the outer body can be coupled to a portion of the outer hub distal to the outer flange. The base of the outer body can be coupled to the collar at a location proximal to where the inner bag is coupled to the conduit. The base of the outer body is spaced from the conduit.

[0013] The collar can define a plurality of suction openings. The suction openings can extend through the outer hub and be located in the outer flange. The suction openings are in fluid communication with the cavity and further in fluid communication with the second volume. Indicia can be disposed or coupled to the collar to provide visual guidance to a user during insertion of the device. The indicia can be a colored marker, such as a colored material on the outer flange.

[0014] The cervical portion may include a seal. The seal may include a head and a base. The head may be coupled to the collar and the base may be coupled to the conduit. The head may be coupled to the outer hub of the collar at a location proximal to the flange. The seal may be of variable thickness along its length defined between the head and the base. The axial location of the variable thickness may be designed based on a desired expansion profile. The seal may define a third volume in fluid communication with the second inflation path defined by the conduit. The conduit further defines a second inflation port providing fluid communication between the second inflation path and the third volume. A barrier in the collar may maintain fluid separation between the second volume and the third volume. The cervical portion may include another inner bag for expanding the seal into the expanded configuration.

[0015] The system may include a connector that facilitates releasable coupling of the multiple sections of the conduit. The connector is optional. The conduit defines an aspiration path, a first inflation path, and a second inflation path, such that each of the multiple sections of the conduit, when releasably coupled together via the connector, defines multiple portions of the multiple paths. The multiple lumens of the conduit may be of different sizes. The effective cross-sectional area of ​​the aspiration path may be greater than the effective cross-sectional area of ​​each of the first and second inflation paths. The conduit may have a constant outer diameter. The relative cross-sectional areas may be such that the effective cross-sectional area of ​​the aspiration path is within the range of 0.50 to 0.65 square inches.

[0016] The control hub includes a module housing coupled to the vacuum line, the first supply line, and the second supply line. The control hub selectively and individually controls the deployment of the intrauterine portion, the deployment of the cervical portion, and the vacuum drawn by the device. The control hub includes at least a first user input and optionally a second user input. The first user input receives an input for activating a vacuum valve to permit or prevent a vacuum from being drawn on the plurality of suction openings and the second volume. The second user input receives another input for activating a first expansion valve to permit or prevent fluid from passing through the first supply line into the pouch of the intrauterine portion. The vacuum valve is configured to be disposed in fluid communication with a suction path of the conduit, and the first expansion valve is configured to be disposed in fluid communication with a first expansion path of the conduit. The first and second user inputs may be switches, knobs, electronically actuated buttons, or the like. The control hub may include a second expansion valve disposed in fluid communication with a second expansion path of the conduit. The second expansion valve is operable to allow or prevent fluid from the second fluid source from being directed to or removed from the second volume. The first expansion valve and / or the second expansion valve may be a self-sealing fitting, such as a self-sealing Luer fitting, configured to be coupled to a saline syringe.

[0017] In certain implementations, the device may include at least one sensor arranged to communicate wired or wirelessly with the controller. The sensor may be arranged in the intrauterine portion or the cervical portion or both. The sensor is configured to generate and transmit a signal to the controller to identify a force being applied by the device to the uterine wall. The sensor may be a contact sensor, a force sensor, a displacement sensor, etc. The controller may be configured to operate a pump based on a signal from the sensor to correspond to the force applied by the uterine wall to the intrauterine portion. The pump may be an electronically actuated syringe or another suitable pressure generating device. The contact sensor may also be configured to transmit a contact signal to the controller or an output device, the signal indicating that the head is in contact with the uterine wall of the uterus. The sensor, controller, and pump are optional, and characteristics of the operation of the device may be obtained by other means, such as electronic sensing and feedback of a medical waste collection system.

[0018] Thus, according to certain aspects of the present disclosure, there is provided a device for treating a uterus. The device includes a conduit, the conduit defining a suction path and an inflation path. An inner bag is coupled to the conduit and defines a first volume, the first volume in fluid communication with the inflation path. The device includes an expandable outer body, the outer body disposed to at least partially cover the inner bag and defining a plurality of suction ports. A second volume defined between the inner bag and the outer body is in fluid communication with the plurality of suction ports of the outer body and the suction path of the conduit. The conduit defines a suction port exterior to the inner bag, the suction port in fluid communication with the suction path.

[0019] The inner bag can be disposed entirely within the outer body. The first volume and the second volume can be out of fluid communication. The inner bag can define a channel for maintaining separation between the inner bag and the outer body when the inner bag is in an inflated state and bodily fluid is drawn through the second volume into the suction path. The channel can be defined by a spacer mechanism coupled to or integrally formed with the outer body and / or the inner bag. The spacer mechanism can be struts coupled to the outer body and / or the inner bag. The struts or spacer mechanism define a channel and a plurality of holes aligned with the plurality of suction ports of the outer body. The plurality of holes can be disposed within the channel. The struts can be oriented longitudinally along an inner surface of the outer body.

[0020] The conduit can define a suction port located proximal to the inner bag and another suction port located distal to the inner bag. The conduit can define an inflation port located distal to the suction port and distal to a base of the inner bag. The inner bag can be formed from a resilient material configured to expand when inflation fluid is directed through the inflation path into the first volume, and the outer body is formed from a resilient material configured to conform to the expansion of the inner bag. Alternatively, the inner bag can be formed from a flexible, non-resilient material configured to expand when inflation fluid is directed through the inflation path into the first volume, and the outer body is formed from a resilient material configured to conform to the shape of the inner bag.

[0021] The inner bag may include a base coupled to the conduit, and the inner bag is not otherwise coupled to the conduit. Alternatively, the conduit may include a distal end, and the device further includes a distal cap movably disposed over the distal end, and the inner bag is coupled to the distal cap. The distal end may be tapered, and the distal cap includes a blunt tip. The distal cap may include a body and a cap head extending distally from the body. An outer diameter of the cap head may be smaller than an outer diameter of the body, and a distal tip portion of the inner bag is coupled to the cap head. The distal cap may define a cavity sized to receive the distal end of the conduit. The outer body may not be directly connected to the distal cap.

[0022] The conduit may define a second inflation path. The suction path and the first and second inflation paths may be compartmentalized channels within the conduit. The conduit may have a constant outer diameter, and an effective cross-sectional area of ​​the suction path is greater than the effective cross-sectional area of ​​each of the first and second inflation paths. The device may further include an expandable cervical seal coupled to the conduit, the cervical seal defining a third volume in fluid communication with the second inflation path. The cervical seal may be formed from a sidewall including an outer surface opposite an inner surface, the sidewall defining a thickness between the inner surface and the outer surface. The thickness of the sidewall may vary between opposite ends of the cervical seal.

[0023] A collar may be coupled to the conduit, with the outer body fixedly coupled to the collar, the collar including a barrier disposed to maintain fluid separation between the second volume and the third volume. The collar and cervical seal may be integrally formed or may be separate components fixedly coupled to one another. The conduit may further define a second inflation port located proximal to the barrier. The collar may define a plurality of additional suction ports in fluid communication with the second volume and the suction pathway.

[0024] Advantages of the present invention will be readily understood when the written description is considered in conjunction with the following drawings, in which: [Brief description of the drawings]

[0025] [Figure 1] FIG. 1 is a diagram of a system according to an implementation of the present disclosure, with an intrauterine device of the system positioned within the female anatomy. [Diagram 2] FIG. 1 is a perspective view of the system. [Diagram 3] FIG. 2 is a perspective view of the device. [Figure 4A] FIG. 1 is an exploded view of a first variant of the device. [Figure 4B] FIG. 13 is an exploded view of a second variant of the device. [Figure 5A] FIG. 5 is a plan cross-sectional view of the device of FIG. 3 taken along line 5-5, showing a first variant. [Figure 5B] 5 is a plan cross-sectional view of the device of FIG. 3 taken along line 5-5, showing a second variant. [Figure 6A] FIG. 6 is an elevational cross-sectional view of the intrauterine device of FIG. 3, showing a first variation, taken along line 6-6, with each of the intrauterine and cervical portions of the device shown deployed in an expanded configuration. [Figure 6B] FIG. 6 is an elevational cross-sectional view of the intrauterine device of FIG. 3 depicting a second variation, taken along line 6-6, with each of the intrauterine and cervical portions of the device shown deployed in an expanded configuration. [Figure 7] FIG. 13 is a perspective view of a strut of the device. [Figure 8] FIG. 2 is a perspective view of a collar of the device. [Figure 9] FIG. 13 is an elevational view of another implementation of the device, with the intrauterine and cervical portions shown undeployed in a folded or insertion configuration. [Figure 10] FIG. 10 is an elevational view of the device of FIG. 9, with the intrauterine and cervical portions shown deployed in an expanded configuration. [Figure 11]FIG. 10 is an elevational view of the device of FIG. 9, with the intrauterine portion shown in an undeployed state and the cervical portion shown in a deployed state. [Figure 12] FIG. 10 is an elevational view of the device of FIG. 9, with the intrauterine portion shown in a deployed state and the cervical portion shown in an undeployed state. [Figure 13] FIG. 2 is a front or first perspective view of a connector for releasably joining two portions of a conduit of a system, with multiple lumens of the first portion of the conduit shown in cross-section. [Figure 14] 1 is a rear or second perspective view of the connector and conduit, with multiple lumens of a second portion of the conduit shown in cross-section; FIG. [Figure 15] FIG. 2 is a perspective view of a female component of the connector. [Figure 16] FIG. 2 is a perspective view of the male component of the connector. [Figure 17] 17 is an elevational cross-sectional view of the connector and conduit of FIG. 14 taken along line 17-17. [Figure 18] FIG. 2 is an exploded view of the control hub. [Figures 19A-19D] FIG. 13 is a diagram of an alternative implementation of the intrauterine portion of the device. [Figures 20A-20D] FIG. 13 is a diagram of an implementation of the cervical portion of the device. [Figure 21] FIG. 1 is an elevational view of another implementation of the system, in which at least one sensor of the device is configured to generate a signal indicative of the operating state of the intrauterine portion when deployed, and the controller is configured to operate the pump based on the signal received from the sensor. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0026] 1 and 2 show a system 30 for treating the uterus, most notably the occurrence of abnormal postpartum bleeding. The system 30 includes a device 32 configured to be positioned and deployed within the female anatomy (intracorporeally) and a control hub 34 coupled to the device 32 by a conduit 36. The device 32 can be removably coupled to the control hub 34 by a connector 38. The control hub 34 is configured to be placed in fluid communication with a vacuum source, a first fluid source, and / or a second fluid source. One suitable vacuum source is incorporated in a medical waste collection system commercially available under the trademark Neptune by Stryker Corporation (Kalamazoo, Michigan), which is disclosed in commonly owned U.S. Patent No. 7,621,898, issued November 24, 2009, and U.S. Patent No. 11,160,909, issued November 2, 2021, the entire contents of each of which are incorporated herein by reference. The first fluid source and / or the second fluid source may be a reservoir of saline or other suitable liquid. The reservoir may be a pre-loaded syringe. Alternatively, it is contemplated that the conduit 36 ​​may be coupled to a vacuum source and / or a fluid source directly or indirectly via another intermediate component. In other words, in certain implementations, the control hub 34 may be optional.

[0027] The device 32 provides tamponade and suction-based therapy separately or simultaneously within the uterus. With reference to FIG. 1, the device 32 includes an intrauterine portion 40 configured to be positioned within the uterus (U). The device 32 can include a cervical portion 42 coupled to the intrauterine portion 40, which is configured to be positioned within or adjacent to the cervix (C) (more specifically, the external cervical os). To maintain the position of the device 32 within the female anatomy and maximize the suction drawn from within the uterus by the vacuum source, the cervical portion 42 can be deployed to seal the cervix. With the device 32 supported in place, the intrauterine portion 40 can be deployed within the uterus to an expanded configuration. The deployment of the intrauterine portion 40, as well as the shape of the intrauterine portion 40 itself, facilitates tamponade-based therapy by engaging the uterine wall (UW), including the fundal wall. Vacuum-based therapy can be induced regardless of whether the intrauterine portion 40 is deployed to an expanded configuration. Thus, the device 32 of the present disclosure may be advantageously "dual mode" to treat abnormal postpartum bleeding by promoting homeostasis with tamponade-based therapy and draining excessive intrauterine bleeding with suction-based therapy. Additionally, the configuration and mechanism of deployment of the intrauterine portion 40 allows the device 32 to accommodate uteri of various shapes and sizes, as well as various stages of abnormal postpartum bleeding. It is further contemplated that the device 32 may also be used for drainage-based therapy without suction being drawn by the device 32, drainage or suction-based therapy without tamponade being provided, or only tamponade-based therapy without suction being drawn by the device 32.

[0028] 3, 4A, and 4B, the device 32 includes a conduit 36 ​​and an inner bag 44 coupled to the conduit 36. The conduit 36 ​​defines an aspiration path 46 and an inflation path 48 separate from the aspiration path. In the illustrated implementation, the conduit 36 ​​is a multi-lumen tube with an internal barrier separating the respective lumens to define the aspiration path 46 and the inflation path 48. Alternatively, the conduit 36 ​​may be a bundle of multiple tubes, each tube defining the aspiration path 46 and the inflation path 48. The conduit 36 ​​need not be a continuous length, but may be formed from multiple segments or sections that are fixedly or removably coupled. A suction port 54 defined by the conduit 36 ​​is in fluid communication with the aspiration path 46 (see also FIGS. 5A-6B). The suction passage 46 is configured to be placed in fluid communication with a suction source, and the inflation passage 48 is configured to be placed in fluid communication with a first fluid source.

[0029] The inner bag 44 defines a first volume 52 in fluid communication with the inflation pathway 48, and the suction port 54 is located outside the inner bag 44. The suction port 54 can be located proximal to where the base 56 of the inner bag 44 is coupled to the conduit 36. Additionally or alternatively, the conduit can define multiple additional suction ports proximal or distal to the inner bag 44. Thus, according to one implementation of the device 32, the inner bag 44 of the intrauterine portion 40 is configured to be deployed to an expanded configuration by directing or pumping fluid from a first fluid source through the inflation pathway 48 into the first volume 52. The extent to which the inner bag 44 can be expanded is settable or selectable by the user based on clinical indications and / or controlled by other means disclosed herein. As used herein, expanded configuration refers to widening or lengthening the shape of the inner bag 44 beyond its natural or initial state, and thus includes partial expansion as well as maximum expansion permitted by the properties of the inner bag 44. As a result of the expanded configuration, the intrauterine portion 40 may or may not engage the uterine wall. When the inner bag 44 is in the expanded configuration, the patient's bodily fluids (e.g., blood associated with PPH) may be drawn into the suction path through the suction port 54 and collected in a waste receptacle, such as the built-in container of the Neptune system. These bodily fluids may be collected and analyzed to determine the concentration of blood in the fluid. For example, a device (not shown) may be placed in line (in series) with the conduit 36, such a device may include multiple sensors configured to detect characteristics of the fluid passing therethrough. Such sensors may be optical light sensors, optical camera sensors, ultrasonic sensors, infrared sensors, volumetric flow sensors, weight sensors, and the like.

[0030] The device 32 can include an expandable outer body 58 disposed to at least partially cover the inner bag 44. As best shown in Figures 5A-6B, the inner bag 44 is disposed entirely within the outer body 58, defining a second volume 60 between the inner bag 44 and the outer body 58. In other words, the second volume 60 can be a void bounded by an outer surface 62 of the inner bag 44 and an inner surface 64 of the outer body 58. The second volume 60 is in fluid communication with the suction port 54 of the conduit 36, and thus with the suction pathway 46.

[0031] The outer body 58 defines a plurality of suction openings 66 in fluid communication with the second volume 60. The suction openings 66 are configured to be exposed to the anatomical environment within the uterus. Suction drawn from a vacuum source to the device 32 is configured to draw bodily fluids through the suction openings 66, the second volume 60, and through the suction port 54 into the suction pathway 46 of the conduit 36. The size, shape, quantity, location, spacing, etc. of the suction openings 66 can be designed to provide a desired suction profile within the uterus based on, among other considerations, the expected fluid hold-up area, as well as the desired fluid flow rate through the device 32 at a given suction level. In the illustrated implementation, the plurality of suction openings 66 are arranged in a plurality of longitudinally oriented rows along the outer body 58. The rows are radially arranged around the outer body 58, and more specifically, are equiangularly spaced radially around the outer body 58. Within each of the rows, the plurality of suction openings 66 are equally spaced axially. Even more specifically, the implementation shown includes three rows, each row having eleven suction openings 66, all of the same size. The rows advantageously provide suction along substantially the entire length of the intrauterine portion 40, and are also located near a distal end 68 of the device 32 that is located near the fundus.

[0032] Numerous alternatives are contemplated with respect to the size, shape, quantity, spacing, location, and combinations thereof of the suction openings 66. The multiple suction openings 66 may be of the same size or different sizes. For example, one or more suction openings 66 closer to the cervical canal portion 42 may be larger than the suction openings 66 closer to the distal end 68 of the device 32 (see Figs. 9-12). Alternatively, one or more suction openings 66 closer to the distal end 68 may be larger than the suction openings closer to the cervical canal portion 42. The diameter of the suction openings 66 may be between 1 and 10 millimeters, more particularly between 1 and 5 millimeters. The shape of the suction openings 66 need not be circular, and other suitable geometric shapes such as elongated or slit-like shapes, oval (elliptical), rectangular, etc. may be envisioned. The number of suction openings 66 may also be varied, for example, arranged in more than four rows or less than three rows, with each row including more than twelve or less than eleven openings. More or fewer suction openings 66 may be concentrated closer to the cervical portion 42 than the distal end 68, or closer to the distal end 68 than the cervical portion 42. Along that line, the spacing of the plurality of suction openings 66 may also vary within their rows or as a whole. The location of the plurality of suction openings 66 may be randomly arranged, partially uniformly arranged, or uniformly arranged. The uniform arrangement may include rows of these, or may be "rows" such as those circumferentially spaced in a ring-like arrangement, with the rings spaced axially from one another. The uniform arrangement may be zigzag, serpentine, or spiral. The system 30 may be packaged in a kit including multiple versions of the device 32, each version having different characteristics of the suction openings 66, the selection of which may be made based on clinical indications or other considerations.

[0033] The second volume 60 and the first volume 52 are not in fluid communication with each other. In other words, the inner bag 44 is formed from a fluid-impermeable material configured to prevent the ingress or egress of fluids within the inner bag 44, respectively. As a result, tamponade and suction-based therapy can be achieved separately or simultaneously, and the magnitude of expansion and vacuum level can be controlled separately or co-dependently. Such functionality advantageously addresses fluctuating clinical scenarios that require, for example, more tamponade-based therapy and less suction-based therapy, or more suction-based therapy and less tamponade-based therapy. The magnitude of expansion and vacuum level can be individually set via user input at the control hub 34 or another input device, as described below.

[0034] To facilitate a suction or flow path between the inner bag 44 and the outer body 58 (i.e., the second volume 60), the device 32 may include one or more struts 70 or spacer mechanism 71. The struts 70 or spacer mechanism 71 are configured to maintain a separation between the inner bag 44 and the outer body 58 (when the intra-uterine portion 40 is in the expanded configuration) such that bodily fluids are drawn through the second volume 60 and into the suction path 46. With reference to FIG. 7, the struts 70 may be elongated and may include a number of projections 72 that define a channel 74. The struts 70 define a number of holes 76 disposed within the channel 74. A face 78 of the struts 70 is disposed opposite the projections 72. The spacer mechanism 71 may be shaped similarly to the struts 70 shown in FIG. 7, but may otherwise be integrally formed with the formation of the outer body 58. In other words, the inner surface 64 of the outer body 58 can be formed by suitable manufacturing techniques to include a plurality of protrusions 72 that define channels 74, the protrusions 72 being spacer features 71. Figures 4A, 5A, and 5B show a first variation of the device 32, in which a spacer feature 71 is provided.

[0035] 4B, 6A, and 6B show a second variation of the device 32, in which the plurality of struts 70 are separate components coupled to the outer body 58. In particular, the struts 70 are located between the inner bag 44 and the outer body 58. The illustrated implementation shows that the face 78 engages the inner surface 64 of the outer body 58 and the protrusions 72 engage the outer surface 62 of the inner bag 44. The plurality of holes 76 of the struts 70 are aligned with the plurality of suction openings 66 of the outer body 58. In such an arrangement, the channel 74 of the struts 70 can be considered to define most of the second volume 60 when the intra-uterine portion 40 is in the expanded configuration. In other words, the inner bag 44 can be formed from a resiliently flexible material such that it is generally conformal around the outer body 58 and the struts 70, but the channel 74 of the struts 70 is narrow enough so that the outer surface 62 of the inner bag 44 does not extend therein. During administration of suction-based therapy, bodily fluid is drawn through the suction openings 66 in the outer body 58 and the holes 76 in the struts 70. The bodily fluid travels proximally within the channel 74 and is drawn through the suction port 54 and into the suction pathway 46 of the conduit 36. The struts 70 (and / or spacer mechanism 71) facilitate suction along substantially the entire length of the intrauterine portion 40 while still allowing significant expansion of the intrauterine portion 40 within the uterus as described below. Known devices in which the suction openings are located at the distal end of the device fail to adequately address such considerations. In an implementation:

[0036] The struts 70 may be fixedly coupled to the inner surface 64 of the outer body 58, for example, by an adhesive or an overmolding operation. Additionally or alternatively, the struts 70 may be fixedly coupled to the outer surface 62 of the inner bladder 44. In yet another variation, the struts 70 may be free floating or fixedly coupled to another subcomponent of the device 32. The protrusions 72 may be ridges or rails as shown, or other suitable spacer features such as nodules, fingers, contours, etc. As shown in FIG. 4B, there are three struts 70, hereafter referred to as a plurality. The plurality of struts 70 or spacer features 71 may be longitudinally oriented and radially spaced about the conduit 36 ​​within the outer body 58. More specifically, the plurality of struts 70 or spacer features 71 may be equiangularly spaced radially about the conduit 36 ​​within the outer body 58.

[0037] The struts 70 may be formed from a flexible material to conform to the contours of the intrauterine portion 40 in the expanded configuration. In other words, the struts 70 may be elongated and flexible to allow the struts 70 to bend along their length. The struts 70 may include a flared portion 80 near their respective distal ends. Collectively, the flared portions 80 of the struts 70 flare inwardly toward the conduit 36. Because the inner bag 44 and outer body 58 are generally spherical when the intrauterine portion 40 is in the expanded configuration, the flared portion 80 helps the struts 70 to accommodate a larger radius of curvature near the distal end of the spherical shape. The flared portion 80 also helps improve insertion of the intrauterine portion 40 through the cervix and into the uterus, as described further below. In a first variation including spacer features 71 integrally formed with outer body 58, the flexible material from which outer body 58 is formed also imparts a similar flexibility to spacer features 71 (eg, protrusions 72).

[0038] Numerous alternatives are contemplated with respect to the size, shape, quantity, spacing, location, and combinations thereof of the struts 70, as well as the suction openings 66 in the outer body 58 with which the holes 76 of the struts 70 are aligned. For example, the struts 70 may be in a ring or cage-like arrangement, or may be zigzag, serpentine, or spiral. It is further contemplated that the struts 70 may be separate subcomponents, as shown, or may be integrally formed with at least one of the bladder 44 and the outer body 58. The latter may include a protrusion 72 formed with the outer body 58 by molding or other suitable manufacturing process. The protrusion 72 may be a nodule, finger, ridge, or contour, or other suitable geometric shape. It is contemplated that other means for providing separation between two expandable objects for a flow path between the objects are also contemplated within the present disclosure. Additionally or alternatively, particularly in implementations where the outer body 58 is not present, the aforementioned or additional protrusions may be disposed on the outer surface of the inner bag 44 to maintain separation between the inner bag 44 and the uterine wall.

[0039] The deployment of the intrauterine portion 40 will be described with reference to Figures 5A-6B. The conduit 36 ​​defines an inflation port 82 in fluid communication with the inflation pathway 48. The first volume 52 is configured to receive pressurized fluid to expand the inner bag 44. The inner bag 44 can be configured to expand in all directions, and the outer body 58 can constrain the expansion of the inner bag 44 to provide a desired expansion profile for the intrauterine portion 40. In other words, the inner bag 44 is formed from a resilient material configured to expand upon induction of inflation fluid through the inflation pathway 48 into the first volume 52, and the outer body 58 is formed from a resilient material configured to conform to the expansion of the inner bag 44 (to follow the expansion of the inner bag 44). In particular, the dimensions (e.g., wall thickness, initial shape, etc.) and material of the outer body 58 can be selected accordingly. One example includes the outer body 58 being formed from silicone. Additionally, struts 70 or spacer mechanisms 71 may be located in the outer body 58 to further impart a desired expansion profile by limiting the extent to which the outer body 58 may expand (e.g., stretch). Suitable materials for the intrauterine portion 40 and / or cervical portion 42 may include polymers such as elastomers, nylons, resins, thermoplastics, thermosets, etc., and exemplary manufacturing techniques include injection molding, blow molding, and three-dimensional printing, among others. The materials may have an elastic modulus in the range of 0.01 to 2.0 gigapascals (GPa), and more particularly in the range of 0.1 to 1.0 GPa.

[0040] In another implementation, the inner bag 44 can be designed to provide a contoured profile, and the outer body 58 conforms with the shape of the inner bag 44 with little resistance. In other words, the inner bag 44 can be formed from a flexible, non-elastic material. Because the inner bag 44 is not elastic and therefore stretches only minimally, the first volume 52 is predetermined or fixed and needs to be contained within the outer body 58. As such, the inner bag 44 can be rolled up or folded and configured to unfold or unfold when inflation fluid is directed through the inflation path 48 into the first volume 52. The outer body 58 can be formed from an elastic material configured to stretch and otherwise conform with (follow the shape of) the shape of the inner bag 44. Additionally or alternatively, it is further contemplated that multiple inner bags can be disposed within one or more outer bodies, each of the multiple inner bags configured to be separately adjustably deployed to provide a desired contoured profile to the intra-uterine portion 40.

[0041] 4A-6B show an inflation port 82 located distal to the suction port 54 and distal to the base 56 of the inner bag 44 (i.e., where the inner bag 44 is coupled to the conduit 36). As a result, if desired, insufflation fluid can be directed into the first volume 52 without compromising the bodily fluids drawn through the second volume 60 under suction. The intrauterine portion 40 is configured to expand radially outwardly, for example, to engage the uterine wall at the outer surface of the uterus. The device 32 also advantageously provides that the intrauterine portion 40 expands longitudinally outwardly, i.e., axially distally. In a first variation shown in FIGS. 5A and 5B, the device includes a distal end 86, and the inner bag 44 is not coupled to the distal end 86 or to any structure other than the base 56 of the inner bag 44 coupled to the conduit 36. When the first volume 52 receives pressurized inflation fluid, the inner bag 44 expands in all directions, i.e., radially and axially. It is contemplated that the thickness of the inner bag 44, particularly the thickness of the tip portion 98 of the inner bag 44, may be relatively large to provide the desired expansion profile. The desired expansion profile may be rounder or flatter, as opposed to a generally spherical shape of the inner bag 44.

[0042] In a second variation shown in Figures 6A and 6B, a distal cap 84 is movably positioned to cover a distal end 86 of the conduit 36. The distal end 86 of the conduit 36 ​​may include a base 88 fixedly coupled to seal the distal end of each of the multiple lumens or passages of the conduit 36. The distal end 86 tapers inwardly from the base 88. The distal cap 84 defines a cavity 90 sized to receive the distal end 86. More specifically, the distal cap 84 includes a body 92 and a cap head 94 extending distally from the body 92. The body 92 defines the cavity 90, and the cap head 94 may include a blunt (rounded) tip 96. The inner bag 44 is coupled to the distal cap 84, and in particular, a tip portion 98 of the inner bag 44 may be coupled to the cap head 94 of the distal cap 84. The outer diameter of the cap head 94 can be smaller than the outer diameter of the barrel 92 such that the tip portion 98 coupled to the cap head 94 provides a generally smooth profile. Note that the outer body 58 does not have to be directly coupled to the distal cap 84.

[0043] When the first volume 52 receives pressurized inflation fluid, the inner bag 44 can expand in all directions. The base 56 of the inner bag 44 is fixedly coupled to the conduit 36 ​​itself, while the tip portion 98 of the inner bag is fixedly coupled to the distal cap 84 rather than to the conduit 36. Distal forces from the axial expansion of the inner bag 44 cause the distal cap 84 to move distally along the distal end 86 of the conduit 36, thereby allowing the inner bag 44 to expand axially. In other words, the intrauterine portion 40 can spread and lengthen within the uterus. FIG. 6B shows the proximal end of the distal cap 84 spaced apart from the distal end 88 of the distal end 86. The extent to which the intrauterine portion 40 lengthens may be at least 10%, 15%, 20%, or 30%, or more. The maximum extent to which the inner bag 44 can be axially expanded is less than the initial distance that the distal end 86 is disposed within the cavity 90 so as not to separate the distal cap 84 from the conduit 36. The intrauterine portion 40 can be lengthened so that the distal end 68 of the device 32 contacts the fundus. In combination with the device expanding spherically, the shape of the device 32 may advantageously be contoured to substantially the entire uterus to promote homeostasis with tamponade-based therapy. In addition to the first variation, it should be noted that in implementations in which the inner bag 44 is formed from an inelastic, non-expandable material, the distal cap 84 may be optional since the extent of axial expansion is based on the predetermined shape of the inner bag 44.

[0044] With continued reference to FIGS. 4A-6B and further reference to FIG. 8, the device 32 includes a collar 100. The collar 100 provides several benefits, which will be described below. The collar 100 is coupled to the conduit 36. In particular, the collar includes an inner hub 102, an outer hub 104, and a barrier 106 coupling the inner hub 102 and the outer hub 104. The inner hub 102 may be directly connected to the conduit 36, for example, by an adhesive or other suitable bonding means. The barrier 106 may extend radially outward from the inner hub 102 to the outer hub 104. The inner hub 102 may be located proximally from the barrier 106, and the outer hub 104 may define a cavity 108 distal to the barrier 106. The cavity 108 is in fluid communication with the second volume 60, and the suction port 54 may be axially located within the cavity 108.

[0045] A base 110 of the outer body 58 is coupled to the collar 100 by an adhesive or other suitable joining means or manufacturing technique. In particular, the outer hub 104 may include a flange 112, and the base 110 of the outer body 58 may be coupled to a portion of the outer hub 104 distal to the flange 112. Additionally, the base 110 of the outer body 58 is coupled to the collar 100 at a location proximal to where the bladder 44 is coupled to the conduit 36, thereby establishing fluid communication between the second volume 60 and the cavity 108. In other words, the second volume 60 may be considered to include the cavity 108.

[0046] The relative dimensions (e.g., outer diameters) of the collar 100 and the conduit 36 ​​cause the base 110 of the outer body 58 to be spaced from the conduit 36. The radial spacing provides several advantages over known devices in which a balloon is directly coupled to the conduit. First, the relatively large initial width of the outer body 58 in the insertion configuration provides a smoother profile in the expanded configuration, thereby better conforming to the contours of the uterus just inside the cervix. Second, the collar 100 provides a rigid structure configured to be grasped by a user during insertion, positioning, and / or repositioning of the device 32. The collar 100 can be formed from a biocompatible material having suitable rigidity to allow a user to grasp the collar 100 to support and manipulate the device 32. The collar 100 can include gripping features (e.g., texturing).

[0047] Third, to improve manipulation of the device 32 with the collar 100, in combination with the distal cap 84 described above, the collar 100 is fixedly coupled to the conduit 36, facilitating stacking of the sub-components. More specifically, the conduit 36 ​​is fixedly coupled to the inner hub 102 of the collar 100, and the proximal portion 114 of the conduit 36 ​​(e.g., the portion defining the multiple lumens) can have some flexibility to allow some degree of lateral bending of the conduit 36. The degree of lateral bending may be 5 degrees, 10 degrees, or 15 degrees, or more, from the longitudinal axis of the device 32. However, the distal end 86 and distal cap 84 of the conduit 36 ​​may be relatively inflexible such that stacking of the sub-components prevents lateral "buckling" of the intrauterine portion 40 against resistance from the female anatomy with the intrauterine portion 40 in the insertion configuration and with the user gripping the device 32, perhaps only by the collar 100. In other words, the degree of lateral bending of the intrauterine portion 40 can be substantially limited to that provided by the flexibility of the proximal portion 114 of the conduit 36. Additionally, the struts 70 can also provide additional columnar strength or lateral stability to the device 32 during insertion, positioning, and repositioning. Taken together, the stacking of the subcomponents facilitates intuitive, ergonomic, and reliable in situ positioning of the device 32. At the same time, the stacking of the subcomponents provides a degree of slack or "flexibility" to prevent damage to the sensitive tissues of the female anatomy and to accommodate differently shaped uteruses.

[0048] Markings (not shown) can be placed on or associated with the collar 100 to provide visual guidance to the user during insertion of the device 32. The markings can be colored markers or markers visible under ultrasound or fluoroscopic guidance. Additionally or alternatively, the collar 100 itself can be formed from a colored material. The colored material can be located on the flange 112. During insertion, once the user can no longer see any side of the colored material, it can be assumed that the collar 100 is just inside the cervix and the device 32 is in the proper position for deployment. If it is desired to understand the rotational orientation of the device 32 within the uterus, additional markings can be provided to correspond to the forward, upward facing side of the device 32 that is visible to the physician when the device 32 is positioned within the uterus.

[0049] The illustrated implementation shows the collar 100 defining a plurality of suction openings 116. The suction openings 116 may extend through the outer hub 104 and, more particularly, may be located within the flange 112 such that the edges of the flange 112 provide a positioning mechanism for positioning the base 110 of the outer body 58 and the head 118 of the cervical portion 42, as described below. The suction openings 116 are in fluid communication with the cavity 108 and further in fluid communication with the second volume 60. It can also be seen from FIGS. 5 and 6 that the axial location of the suction openings 116 of the collar 100 is proximate to the suction port 54 of the conduit 36. The location and size of the plurality of suction openings 116 allows the suction drawn through the collar 100 into the uterus to be relatively greater than the suction drawn through the suction openings 66 of the outer body 58. As can be generally seen from FIG. 1, the collar 100 is configured to be positioned within the uterus just inside the cervix, a location within the uterus that has been shown to be frequently prone to excessive pooling of blood during abnormal postpartum bleeding. Thus, the device 32 advantageously addresses such a problem by providing less restrictive suction in the most appropriate location. The perspective view of FIG. 8 shows the collar 100 including four suction openings 116 spaced equiangularly radially about the flange 112. It will be appreciated that more than four or less than four suction openings may be provided, and that the multiple suction openings 116 may be positioned about the collar 100 in any regular or irregular fashion.

[0050] Turning to the cervical portion 42, the cervical portion 42 is configured to be deployed into an expanded configuration to engage and preferably seal against the cervix. Engaging the cervical portion 42 facilitates accurate positioning and fixation of the intrauterine portion 40 within the uterus without the need for much observation and adjustment by the attending physician compared to known devices that require manual intervention. Additionally, sealing against the cervix maintains an optimal vacuum for vacuum-based therapy. Referring again to FIGS. 5A-6B, the cervical portion 42 can include a seal 120. The seal 120 can include a head 118 and a base 122. The seal 120 can be integrally formed of a suitable resiliently flexible biocompatible material. In such implementations, the head 118 and base 122 can define the portion of the seal 120 that is coupled to other structures of the device 32.

[0051] 5A and 5B depict the cervical seal 42 and collar 100 as integrally formed subcomponents, with the collar 100 being considered to be the distal collar portion of the cervical seal 42. This can be facilitated by suitable manufacturing techniques that provide the desired stiffness to the distal collar portion and the desired resilience to the seal 120. In a second variation shown in FIGS. 6A and 6B, the head 118 of the seal 120 can be coupled to the collar 100 and the base 122 can be coupled to the conduit 36. In particular, the head 118 is coupled to the outer hub 104 of the collar 100 at a location proximal to the flange 112. The head 118 is fixedly coupled to the outer hub 104 by adhesive or other suitable joining process or manufacturing technique. Similarly, the base 122 can be fixedly coupled to the proximal portion 114 of the conduit 36 ​​by adhesive or other suitable joining process or manufacturing technique.

[0052] In optional implementations, the cervical portion 42 can be configured to expand non-uniformly in the axial direction. As best shown in FIG. 6, the seal 120 can include a point of maximum radial expansion 124, which conveniently defines the boundary between the proximal portion 126 and the distal portion 128 of the seal 120. As used herein, non-uniform in the axial direction means that the contour or profile of the seal 120 differs between the proximal portion 126 and the distal portion 128. The elevational cross-sections of FIGS. 5B and 6B show the proximal portion 126 flaring (flaring out) proximally, while the radial contour of the distal portion 128 is relatively unnoticeable. The non-uniform axial profile is provided by the thickness of the seal 120, defined between the head 118 and the base 122, being variable along its length. In particular, the proximal portion 126 of the sealer 120 has a first thickness (t1) and the distal portion 128 has a second thickness (t2) that is less than the first thickness. The axial location of the first thickness can be designed based on the desired axially non-uniform profile and / or the material (e.g., elastic modulus) forming the sealer 120. The thinner sides of the sealer 120 are more likely to stretch than the thicker sides of the sealer 120, which may in turn flex to provide the axially non-uniform profile. Among other benefits, the axially non-uniform profile provides improved engagement and sealing of the cervix, particularly the post-partum cervix where the cervix has expanded and thinned.

[0053] The cervical portion 42 is configured to receive fluid and be deployed to the expanded configuration. The seal 120 can define a third volume 130 in fluid communication with the second inflation path 50 defined by the conduit 36 ​​(see also FIGS. 4A and 4B). The conduit 36 ​​further defines a second inflation port 132 providing fluid communication between the second inflation path 50 and the third volume 130. The barrier 106 of the collar 100 can maintain fluid separation between the second volume 60 and the third volume 130. In other words, it will also be understood that the second inflation port 132 can be located proximal to the suction port 54, and the second inflation port 132 is located proximal to the first inflation port 82. Thus, according to one implementation of the device 32, the cervical portion 42 is configured to be deployed to an expanded configuration by directing or pumping fluid from the second fluid source through the second inflation pathway 50 into the third volume 130. The degree to which the sealant 120 can be expanded can be set or selected by the user based on clinical indications and / or controlled by other means disclosed herein. As used herein, expanded configuration refers to widening or lengthening the shape of the sealant 120 beyond its natural state, and thus includes partial expansion as well as maximum expansion permitted by the properties of the sealant 120.

[0054] The cervical portion 42 may be wider than the intrauterine portion 40 in the insertion configuration, although alternative arrangements are contemplated. In one example, the ratio of the maximum outer diameter of the intrauterine portion 40 to the maximum outer diameter of the cervical portion 42 is within a range of 0.7:1 to 1:0.9 in the insertion configuration. A smaller intrauterine portion 40 may be particularly well suited in cases of insufficient cervical dilation. The intrauterine portion 40 may be configured to have a maximum expansion that is greater than the maximum expansion of the cervical portion 42. For example, the ratio of the maximum outer diameter of the intrauterine portion 40 to the maximum outer diameter of the cervical portion 42 is within a range of 1.2:1 to 3.0:1 in the expanded configuration. This ratio may be based on the respective sizes and / or materials from which the intrauterine portion 40 and cervical portion 42 are formed. For example, the intrauterine portion 40 may be formed from a first elastomer having a first elastic modulus, and the cervical portion 42 may be formed from a second elastomer having a different second elastic modulus. Again, based on the partial or complete separate deployability of the intrauterine portion 40 and cervical portion 42, the device 32 of the present disclosure accommodates uteri of various shapes and sizes, as well as various stages of abnormal postpartum bleeding.

[0055] 9-12, another implementation of the device 32 is shown, with like numerals indicating like components. In the illustrated implementation, the outer body 58 of the intrauterine portion 40 and the seal 120 of the cervical portion 42 are single piece components of the device 32. In other words, the single piece components of the device 32 can be manufactured to be structurally monolithic or unitary, and the device 32 is shaped to a contour profile complementary to the female anatomy. In such an arrangement, a central taper (similar to the collar 100) can define the boundary between the intrauterine portion 40 and the cervical portion 42. The intrauterine portion 40 and / or the cervical portion 42 can be formed from multiple materials based on the desired expansion and other properties of the device 32. For example, the intrauterine portion 40 can be formed from a first elastomer having a first elastic modulus, and the cervical portion 42 can be formed from a second elastomer having a different second elastic modulus.

[0056] The intrauterine portion 40 and cervical portion 42 are at least partially formed from a flexible material, even an elastically flexible material. The elastic material and / or shape of the device 32 can be specially designed to provide sufficient columnar strength to facilitate (facilitate) insertion and placement of the device 32, if desired. The device 32 can be sufficiently rigid to self-support its weight when grasped proximally, for example, when manipulated by or near the proximal end of the cervical portion 42, or at the central taper. The device 32 is also sufficiently flexible so that it can be folded for insertion and then expanded once inside the female anatomy. In other words, this implementation of the device 32 may not be as "floppy" as conventional balloon-type devices. The material properties and contour profile of the device 32 are configured to allow better manipulation of the device 32 to apply a distally directed axial force to pass the intrauterine portion 40 through the cervix against (against) resistance from the cervical os. The resulting columnar strength advantageously provides improved insertion through a C-section or through a cervix that may be sized smaller than the outer diameter of the device 32. However, it is contemplated that the device 32 may include reinforcing members (similar to struts 70 or spacer mechanisms 71) overmolded into or coupled to the outer body 58 of the intrauterine portion 40 to provide additional columnar strength, if desired.

[0057] Suitable materials for the intrauterine portion 40 and / or cervical portion 42 may include polymers such as elastomers, nylons, resins, thermoplastics, thermosets, etc., and exemplary manufacturing techniques include injection molding, blow molding, and three-dimensional printing, among other techniques. The materials may have an elastic modulus in the range of 0.01 to 2.0 gigapascals (GPa), more particularly in the range of 0.1 to 1.0 GPa. Suitable wall thicknesses may be in the range of 0.1 to 1.0 centimeters (cm), more particularly in the range of 0.4 to 0.7 cm. The wall thickness may be based on material properties to achieve a desired columnar strength and / or contour profile in the expanded configuration. For example, thicker portions of the device 32 may have a lower elastic modulus to allow for greater radial expansion during deployment without compromising columnar strength. The greater radial expansion of the intrauterine portion 40 is particularly important because it contours to the wider upper surface of the uterus, yet is flexible enough to conform to the uterus from resistance by the uterine wall.

[0058] The expanded profile of the device 32 will be described with continued reference to Figures 9-12. The intrauterine portion 40 includes a head 134, a neck 136, and a crown 138. The neck 136 and the crown 138 extend in opposite directions (bidirectional) from the head 134. More specifically, the neck 136 extends proximally from the head 134 and the crown 138 extends distally from the head 134. As shown, the neck 136 can taper radially inward from the head 134 and the crown 138 can also taper radially inward to define the distal end 68 of the device 32. The distal end 68 is blunt (rounded) to provide a contour that distributes forces around the crown 138 during insertion while avoiding puncturing and otherwise injuring the anatomy. In such an arrangement, the intrauterine portion 40 can be considered to be generally spherical in shape. When the intra-uterine portion 40 is in the insertion or original configuration, the outer diameter of the head 134 can be at least slightly larger than each of the neck 136 and crown 138. The relative expansion of the head 134, neck 136, and crown 138 can vary, e.g., the head 134 expands to a greater extent than the neck 136 and / or crown 138. It is further contemplated that a kit can be provided (e.g., in a blister pack) in which several versions of the device 32 each have their own shape and / or expansion characteristics. The user can then select the version that best suits their likelihood of contouring to the shape of the uterus in the initial state and / or expanded configuration.

[0059] The outer body 58 of the intrauterine portion 40 defines a plurality of suction openings 66. The plurality of suction openings 66 may be arranged in a plurality of rows (columns) spaced apart from one another and oriented radially around the intrauterine portion 40. One or more of the head 134, neck 136, and crown 138 may not include a suction opening 66. The suction openings 66 are in fluid communication with a second volume 60 defined between an inner surface 64 of the outer body 58 and an outer surface 62 of the inner bag 44. The suction openings 66 are further in fluid communication with a conduit 36 ​​that extends at least partially through the intrauterine portion 40, the conduit 36 ​​defining at least one suction port 54 in fluid communication with the suction openings 66. FIGS. 9 and 11 show the conduit 36 ​​defining a proximal suction port and a distal suction port. This arrangement allows bodily fluids to pass through the suction opening 66, the second volume 60, and the suction port 54 and exit or be drawn through the conduit 36. In other words, the intrauterine portion 40 can be positioned within the uterus without a vacuum to allow for the entry of bodily fluids through the device 32 (e.g., following uterine contractions), or can be positioned within the uterus with a vacuum applied to draw bodily fluids through the device 32. In such implementations, a drainage bag (not shown) can be coupled to the conduit 36 ​​or the control hub 34 to capture patient fluids. The device 32 can be operated with or without suction, regardless of whether the intrauterine portion 40 is deployed to an expanded configuration. In other words, the intrauterine portion 40 can be operated with or without suction in the original state shown in Figures 9 and 11, and can be operated with or without suction in the expanded configuration shown in Figures 10 and 12.

[0060] The outer body 58 may further define at least one recess 140, with the plurality of suction openings 66 disposed in and in fluid communication with the recess 140. Locating the suction openings 66 in the recess 140 prevents or limits vacuum-based blockage of the suction openings 66, thereby maintaining a desired vacuum strength and profile within the uterus. There may be one or more suction openings 66 within each of the one or more recesses 140. The following disclosure describes the location of the plurality of suction openings 66 in each of the plurality of recesses 140. In the illustrated implementation, the recesses 140 are oriented longitudinally or substantially parallel to the longitudinal axis of the device 32. The distal end of the recess 140 may terminate proximal to the crown 138 or proximal to the distal end 68 of the device 32. Additionally, optionally, the plurality of recesses 140 may be radially disposed around the intrauterine portion 40, and the plurality of recesses 140 may be equiangularly disposed around the intrauterine portion 40. Further, optionally, multiple suction openings 66 may be equally spaced within recess 140. The foregoing arrangement may be particularly well suited when shown to provide a uniform vacuum profile about intrauterine portion 40.

[0061] Variations in the location and geometry of the plurality of suction openings 66 and / or recess 140 are contemplated, i.e., variations disclosed in connection with the above-described implementations of device 32. Further examples include a proximal opening of the plurality of suction openings 66 being oval and larger than the other suction openings 66. One or more of the suction openings 66 may be circular, oval, rectangular, and may span any length within recess 140. The size, shape, and / or location of the plurality of suction openings 66 within recess 140 may be modified to provide a desired vacuum profile around device 32. A higher or lower density of suction openings 66 may also be located in head 134, neck 136, or crown 138. A higher density of suction openings 66 within head 134 may be provided to accommodate the anatomical junction between the uterine artery and the uterus. With respect to the geometry of recess 140, recess 140 may be elongated or generally linear, as shown. Variations include that in addition to longitudinal recesses, the recesses extend circumferentially around the head 134, for example to provide a grid. Further variations include that the recesses 140 are zigzag, spiral, etc.

[0062] The recesses 140 may be equiangularly spaced around the intrauterine portion 40. Alternative implementations include asymmetric placement of the recesses 140 based on anatomical regions where more bleeding is expected. For example, with a patient lying supine, blood and other bodily fluids are more likely to collect posteriorly in the uterus due to the effects of gravity. Thus, it is contemplated that a higher density of suction openings 66 may be provided in a posterior portion (not shown) of the intrauterine portion 40 when oriented in a given insertion direction. Markings may be provided on the proximal components of the device to correspond to the forward, upward facing surface of the device 32 that is visible to the physician when the device 32 is positioned in the uterus. Orienting the markings upward positions the higher density of suction openings 66 posteriorly. Other arrangements of the recesses 140 to promote a desired vacuum profile are within the scope of this disclosure.

[0063] In this implementation, the inner bag 44 can expand uniformly, with the outer body 58 restraining the expansion to provide a contoured profile. Alternatively, the inner bag 44 can be designed to provide a contoured profile, with the outer body 58 conforming to the shape of the inner bag 44 with little resistance. In one variation, the inner bag 44 can include multiple inner bags, each configured to be deployed separately to provide a contoured profile to the outer body 58. For example, a separate inner bag can be disposed within each of the head 134, neck 136, and crown 138 to provide a more pronounced or varying contour to the outer body 58. The intrauterine portion 40 can be configured to expand axially and radially. In other words, the materials and dimensions of the intrauterine portion 40 can be designed such that when the inner bag 44 is filled with fluid, the device 32 will be longer and wider within the uterus. The extent to which the device 32 lengthens may be at least 5%, 10%, 15%, or 20%, or more. The intrauterine portion 40 may be lengthened so that the distal end 68 contacts the fundus.

[0064] One or both of the inner bag 44 and the outer body 58 may include a spacer mechanism 71 to maintain a small gap between the inner bag 44 and the outer body 58 despite the inner bag 44 expanding the outer body 58. The spacer mechanism 71 may be a nodule, protrusion, ridge, or contour defined in the inner bag 44 and / or the outer body 58. The suction path is further defined by the suction ports 54, specifically the proximal suction port 54. The proximal suction port 54 is located within the outer body 58 proximal to the proximal end of the inner bag 44. Thus, the proximal suction port 54 remains open with the expansion of the inner bag 44 within the outer body 58. The vacuum source draws blood from within the uterus through the suction opening 66, along the second volume 60 between the inner bag 44 and the outer body 58, and through the proximal suction port 54. It is further noted that the proximal suction port is optimally located within the lower uterine segment to better drain blood that may have accumulated within the anatomical region.

[0065] In this implementation, the cervical portion 42 can be unfolded by filling a separate inner bag 142 with a fluid, such as saline, to expand the sealant 120 into an expanded configuration, and thus the intrauterine portion 40 and the cervical portion 42 can be separately unfolded. FIG. 9 shows the unfolded intrauterine portion 40 and the unfolded cervical portion 42, for example during initial placement of the device 32. FIG. 10 shows the unfolded intrauterine portion 40 and the unfolded cervical portion 42 in an expanded configuration, for example during tamponade-based (and optionally suction-based) treatment. FIG. 11 shows the unfolded intrauterine portion 40 and the unfolded cervical portion 42. FIG. 12 shows the unfolded intrauterine portion 40 and the unfolded cervical portion 42. The intrauterine portion 40 can be smaller or larger than the cervical portion 42, and can further expand to a lesser or greater extent than the cervical portion 42. In one example, the ratio of the maximum outer diameter of the intrauterine portion 40 to the maximum outer diameter of the cervical portion 42 is within a range of 0.8:1 to 1:1.2 in the original state. In other words, when unfolded, the intrauterine portion 40 may be slightly narrower or slightly wider than the cervical portion 42. In another example, the ratio of the maximum outer diameter of the intrauterine portion to the maximum outer diameter of the cervical portion may be within a range of 1:2.0 to 1:4.0 in the original state. The intrauterine portion 40 may demonstrate sufficient collapsibility to be inserted through an opening, despite its relatively large outer diameter. Conversely, the intrauterine portion 40 may be narrowed by removing the initial air in the inner bag 44, after which the elastic material forming the intrauterine portion 40 returns to its original state. Similarly, the cervical portion 42 may also be narrowed by removing the initial air from the inner bag 142.

[0066] As previously described, the suction path 46 is configured to be placed in fluid communication with a vacuum source, the first inflation path 48 is configured to be placed in fluid communication with a first fluid source, and the second inflation path 50 is configured to be placed in fluid communication with a second fluid source. This can be accomplished by the connector 38 and the control hub 34, each as described below. With reference to FIGS. 13 and 14, the connector 38 facilitates releasable coupling of the first section 36a and the second section 36b of the conduit 36. The first section 36a extends to and can include the proximal portion 114 of the conduit 36 ​​already discussed (see FIGS. 5 and 6). The connector 38 includes a female component 144 fixedly or releasably coupled to the second section 36b and a male component 146 fixedly or releasably coupled to the first section 36a.

[0067] 15 and 17 show a female component 144 including an end wall 148 and at least one fitting 150 extending from the end wall 148 to define a first end of the female component 144. An outer wall 152 extends from the end wall 148 to define a second end of the female component 144. The outer wall 152 defines a first cavity 154. A first inner wall 156 is coaxially disposed within the outer wall 152. The outer wall 152 extends from the end wall 148 a distance less than the distance the outer wall 152 extends from the end wall. The first inner wall 156 has a first inner diameter and defines a second cavity 158 within the first cavity. The female component 144 includes a second inner wall 160 coaxially disposed within the first inner wall 156 and extending from the end wall 148. The second inner wall 160 extends from the end wall 148 a distance less than the distance that the first inner wall 156 extends from the end wall 148. The second inner wall has a second inner diameter and defines a third cavity 162 within the second cavity 158.

[0068] The male component 146 includes a first section 164 having a first outer diameter sized to be received within the first cavity of the female component. The first section 164 includes at least one fitting 166 and defines a first offset bore 168 configured to be disposed in fluid communication with the first cavity 154 of the female component 144. A second section 170 is coaxially disposed relative to the first section 164 and has a second outer diameter sized to be received within the second cavity 158 of the female component 144. The second section 170 defines a second offset bore 172 configured to be disposed in fluid communication with the second cavity 158 of the female component 144. A third section 174 is coaxially disposed relative to the second section 170 and has a third outer diameter sized to be received within the third cavity 162 of the female component 144. The second section 170 defines a central bore 176 disposed in fluid communication with the third cavity 162 of the female component 144. A first seal 178a is coupled to the first section 164, a second seal 178b is coupled to the second section 170, and a third seal 178 is coupled to the third section 174.

[0069] The fitting 166 of the male component 146 may be a first fitting 166a in fluid communication with the first offset bore 168 and a second fitting 166b in fluid communication with the second offset bore 172. A face 180 of the male component 146 defines a non-circular opening 182 between the first fitting 166a and the second fitting 166b, the non-circular opening 182 in fluid communication with the central bore 176. On the female component 144, the fitting 150 may be a first lateral fitting 150a in fluid communication with the first cavity 154, a second lateral fitting 150b in fluid communication with the second cavity 158, and a third central fitting 150c in fluid communication with the third cavity 162. The third central mount 150c may be larger than the first lateral mount 150a and the second lateral mount 150b.

[0070] The conduit 36 ​​defines a suction passage 46, a first inflation passage 48, and a second inflation passage 50, and thus defines portions of the passages 46, 48, 50 when each of the first section 36a and the second section 36b are removably coupled together via the connector 38. As best shown in FIGS. 4A, 4B, 13, and 14, the lumens of the conduit 36 ​​are of different sizes. In particular, the effective cross-sectional area of ​​the suction passage 46 is greater than the effective cross-sectional area of ​​each of the first inflation passage 48 and the second inflation passage 50. In other words, the conduit 36 ​​can have a constant outer diameter, and a relatively large cross-sectional area of ​​the conduit 36 ​​is dedicated to the suction passage 46. Such an arrangement advantageously accommodates the often high demands for suction. To minimize the outer diameter of the conduit 36 ​​while facilitating this arrangement, the suction passage 46 may be non-circular, with the implementation shown being one non-limiting example. The relative cross-sectional areas can be such that the effective cross-sectional area of ​​the suction passage 46 is within the range of 0.50 to 0.65 square inches. Minimizing the outer diameter can be less of an issue when the second section 36b of the conduit 36 ​​extends between the connector 38 and the control hub 34, and is thereby located further away from the patient. In the implementation shown, the second section 36b can be wide and thinned to have a ribbon-like shape, with the first and second inflation passages 48, 50 located on either side of the larger diameter suction passage 46.

[0071] The second section 36b of the conduit 36 ​​is removably coupled to the female component 144 of the connector 38. More specifically, the first inflation passage 48 is coupled to the first fitting 150a, the second inflation passage 50 is coupled to the second lateral fitting 150b, and the suction passage 46 is coupled to the third central fitting 150c. Similarly, the first section 36a of the conduit 36 ​​is removably coupled to the male component 146 of the connector 38. The first inflation passage 48 is coupled to the first fitting 166a, and the second inflation passage 50 is coupled to the second fitting 166b. A corresponding fitting (not shown) of the first section 36a is disposed in fluid communication with the non-circular opening 182.

[0072] In alternative implementations, the cavities defined by the connector 38 may not be coaxial, but may be laterally offset from one another. Correspondingly, the first and second sections 36a, 36b of the conduit 36 ​​are modified to match the lateral offset of each of the suction path 46, the first inflation path 48, and the second inflation path 50.

[0073] When desired or otherwise indicated, the female component 144 and the male component 146 are coupled together as described above and as shown in FIG. 17. This arrangement establishes fluid communication for the suction path 46 through the central bore 176 and the third cavity 162, for the first inflation path 48 through the first offset bore 168 and the first cavity 154, and for the second inflation path 50 through the second offset bore 172 and the second cavity 158. The connector 38 facilitates a quick, intuitive, compact, and removable coupling between the sections 36a and 36b of the conduit 36 ​​having at least three paths. Such an advantage may be particularly useful for certain procedures and workflows. For example, the device 32 may also be configured for use in a Caesarean section, where the device 32 is guided through the Caesarean section rather than through the cervix. The outer diameter of the female component 144 of the connector 38 is small enough to pass through the cervix even with minimal expansion. The connector 38 can be removably coupled to the male component 146 of the connector 38 after being passed further through and out of the vagina. This coupling step can occur before or after the device 32 is positioned within the female anatomy as desired. In another example involving a vaginal birth and Cesarean section, the connector 38 allows a primary user to perform the initial placement of the device 32 within the female anatomy and a secondary user to position the conduit 36, connector 38, and control hub 34, thereby improving the efficiency of the surgical workflow.

[0074] 18, the control hub 34 includes a module housing 184 coupled to a vacuum line 186, a first supply line 188, and a second supply line 190. In the broadest sense, the control hub 34 is a subcomponent of the system 30 configured to control the various functions of the device 32 described throughout this disclosure. More specifically, the control hub 34 serves as an intuitive hub for selectively and individually controlling the deployment of the intrauterine portion 40, the deployment of the cervical portion 42, and the drawing of a vacuum through the device 32. The control hub also provides improved line management over known devices that have untidy and ungainly tubes extending from the device. The control hub 34 includes a first user input 192 and can further include an optional second user input 194. The first user input 192 is configured to receive an input for actuating the vacuum valve 196 between an open position that allows a vacuum from the vacuum source to be applied to the suction opening 66 and a closed position that prevents a vacuum from being applied to the suction opening 66 from the vacuum source. In other words, the first user input 192 can be actuated to turn the vacuum in the device 32 on and off and can also be actuated to maintain a vacuum in the device 32 during transport of the patient. The second user input 194 can be configured to receive another input for actuating the first inflation valve 198 to allow or prevent fluid from passing through the first supply line 188 into the inner bag 44 of the intra-uterine portion 40.

[0075] 18, the vacuum line 186, the first supply line 188, and the second supply line 190 are configured to be coupled to the conduit 36. The coupling can be integral such that the lines 186, 188, 190 are continuous with the conduit 36, or the module housing 184 can include a plug or port configured to be removably coupled to the conduit 36. The vacuum valve 196 is configured to be placed in fluid communication with the suction path 46 of the conduit 36, and the first expansion valve 198 is configured to be placed in fluid communication with the first expansion path 48 of the conduit 36. The first user input 192 can be a first switch operably coupled to the vacuum valve 196, the first switch configured to receive a first input to actuate the vacuum valve 196 to allow or prevent suction from the vacuum source from being drawn into the second volume 60. Second user input 194 may be a second switch operably coupled to first expansion valve 198, the second switch configured to receive a second input for actuating first expansion valve 198 to a closed position to maintain inflation of bladder 44 with fluid in first volume 52, as described further below. Additionally or alternatively, user input may be a knob as shown, or may be an electronically actuated button or switch.

[0076] The control hub 34 may include a second expansion valve 202 configured to be disposed in fluid communication with the second inflation path 50 of the conduit 36. The second expansion valve 202 is operable to permit or prevent fluid from a second fluid source from being directed to or removed from the second volume 60, thereby respectively deploying and de-deploying the cervical portion 42. The second expansion valve 202 may be a self-sealing fitting configured to be coupled to a second inflation source. For example, the second expansion valve 202 may be a self-sealing luer fitting configured to be coupled to a fluid source, such as a saline syringe. In a variation in which the second user input 194 is not provided, the second expansion valve 198 may also be a self-sealing luer fitting configured to be coupled to another saline syringe. In yet another variation, a toggle switch (not shown) may be provided in fluid communication with each of the first supply line 188 and the second supply line 190. A single fluid source (e.g., a saline syringe) can be coupled to the control hub 34, and a toggle switch can be actuated to selectively provide fluid to either the intrauterine portion 40 or the cervical portion 42. The control hub 34 can include an optional suction relief valve 200 configured to break the vacuum if the vacuum level exceeds a predetermined threshold.

[0077] The module housing 184 may include indicia on a user-facing side to provide information regarding which of the first user input 192 and the second user input 194 correspond to which of the device 32 actions. Exemplary indicia may be a schematic representation of the female anatomy and / or a schematic representation of the device 32. Additionally or alternatively, indicia may be provided on the first supply line 188 and / or the second supply line 190 to indicate which portion of the device 32 the fluid is directed to. For example, the first supply line 188 may be etched or printed with a "U" to indicate the uterus and the second supply line 190 may be etched or printed with a "C" to indicate the cervix. The module housing 184 may be smaller in form factor so that it can be attached to a patient support apparatus or the patient's leg. A clip (not shown) configured to be coupled to a bed sheet may be coupled to the conduit 36, and / or a hook assembly (not shown) configured to be coupled to a rail or other structure of a patient support apparatus may be coupled to the conduit 36. The module housing 184 may be disposable and therefore sterilization is not indicated, and the module housing 184 may be placed in a sterile field as needed.

[0078] An exemplary method of treating the uterus, and particularly uterine bleeding, during abnormal postpartum bleeding includes providing a system 30 as described herein. The system 30 may be provided in a sterile blister pack. The device 32 and control hub 34 are removed from the blister pack. The connector 38 may or may not already be coupled to a first section 36a of a conduit 36 ​​that extends to the device 32.

[0079] The intrauterine portion 40 is in an insertion configuration and the cervical portion 42 is in an insertion configuration. For a workflow involving transvaginal insertion, the primary user can grasp the device 32 by the collar 100 and guide the distal end 68 of the intrauterine portion 40 through the vagina and then through the cervix. The stacking of the subcomponents facilitates an intuitive and ergonomic insertion. The primary user can observe the markings on the collar 100 to properly position the device 32 against the cervix. For a workflow involving a Cesarean section, the primary user can guide the conduit 36 ​​through the Cesarean section and outward through the cervix and vagina. The cervical portion 42 is properly positioned from the inside against the cervix.

[0080] Either before, during, or after the step of the primary user placing the device 32 in the female anatomy, the secondary user can couple the first section 36a of the conduit 36 ​​as needed. The second section 36b of the conduit 36 ​​can be coupled to the control hub 34 as needed. The female and male components 144 and 146 of the connector 38 are coupled. Either before, during, or after the step of coupling the female and male components 144 and 146 of the connector 38, the vacuum line 186 of the control hub 34 is coupled to a vacuum source. A fitting located at the end of the vacuum line 186 can receive a suction tube from the vacuum source via a friction or interference fit. The vacuum valve 196 can be in a closed position. The first supply line 188 of the control hub 34 is coupled to a first fluid source. The first fluid source can be a saline syringe. A luer fitting located at the end of the first supply line 188 can facilitate (facilitate) this coupling. When the first expansion valve 198 is in the closed position, the syringe remains filled with saline. The second supply line 190 of the control hub 34 is coupled to a second fluid source. The second expansion valve 202 may be a self-sealing Luer fitting configured to be coupled to the second fluid source, i.e., a second saline syringe.

[0081] After confirming proper placement of the cervical portion 42, the second saline syringe is actuated to induce fluid through the second supply line 190, the second inflation passage 50 of the conduit 36, and into the third volume 130 defined by the closure 120. Graduations on the second syringe can provide an indication of the volume of saline induced, and the corresponding amount of expansion can be understood based on known conversions. Additionally or alternatively, the user can feel resistance in the second syringe indicating that the cervix has been engaged by the closure 120. The cervical portion 42 is deployed against the cervix in an expanded configuration. The second syringe is disconnected from the self-sealing luer fitting, after which the cervical portion 42 is maintained in the expanded configuration.

[0082] When it is desired to provide a tamponade-based therapy, the intrauterine portion 40 is deployed. The user actuates the second user input 194 to move the first expansion valve 198 to an open position and further actuates the first saline syringe to induce fluid through the first supply line 188, the first expansion passage 48 of the conduit 36, and into the first volume 52 defined by the inner bag 44. The intrauterine portion 40 is deployed to an expanded configuration. Graduations on the first syringe can provide an indication of the volume of saline induced, and the corresponding amount of expansion can be understood based on known conversions. Additionally or alternatively, the user can feel resistance in the first syringe indicating that the uterine wall has been engaged by the outer body 58. If desired, when the first expansion valve 198 is in the open position, the user can retract the first syringe to withdraw saline from the first volume 52. After being satisfied with the degree of expansion, the user actuates the second user input 194 to move the first expansion valve 198 to a closed position, thereby maintaining the volume of fluid within the inner bag 44 and maintaining the intra-uterine portion 40 in the expanded configuration.

[0083] Whether or not the intrauterine portion 40 is deployed, if it is desired to provide a vacuum-based therapy, the user can perform the step of operating the vacuum source. The vacuum source can be activated, at least initially, with the vacuum valve 196 in a closed position. The user can actuate the first user input 192 to move the vacuum valve 196 at least partially toward an open position. A vacuum is drawn through the suction opening 66, the second volume 60, the suction path 46 of the conduit 36, and the vacuum line 186. If an unexpected spike in the vacuum level occurs, the suction relief valve 200 can open. If not, the vacuum level can be adjusted by the first user input 192 and / or further inputs to the system controlling the vacuum source.

[0084] Tamponade-based and vacuum-based therapies desirably allow the uterus to begin to contract and shrink. The method can include contracting the inner bag 44 to reduce the degree of expansion of the intrauterine portion 40 in response to the shrinkage of the uterus. The user can provide another input to the second user input 194 to move the first inflation valve 198 to an open position and also retract the first saline syringe to withdraw fluid from the inner bag 44. Additionally, the user can adjust the vacuum level in response to the inner bag 44 as this occurs. For example, when the intrauterine portion 40 is fully expanded, a higher or lower vacuum level can be indicated based on the induced contractions. In response to the contraction of the inner bag 44, the vacuum level can be increased or decreased by a predetermined or selected amount. In another example, the vacuum level can be maintained while the inner bag 44 is contracted by a fixed or variable amount at fixed or variable intervals.

[0085] The device 32 can be manufactured by an exemplary method. A collar 100 is slidably disposed over the conduit 36 ​​and secured in place along the conduit 36. The inner bag 44 is secured to a distal cap 84. The distal cap 84 is slidable over the distal end 86 of the conduit 36 ​​with the inner bag 44 attached. The base 56 of the inner bag 44 is secured to the conduit 36 ​​to define the first volume 52. The outer body 58 is disposed over the inner bag 44 and secured to the collar 100 to define the second volume 60 between the inner bag 44 and the outer body 58.

[0086] In a particular method, a plurality of struts 70 are coupled to the inner surface 64 of the outer body 58. For example, the plurality of struts 70 can be placed in a fixture and the outer body 58 can be overmolded over the struts 70. The seal 120 of the cervical portion 42 can be secured to the collar 100 of the conduit 36 ​​to define a third volume 130. The conduit 36 ​​can be extruded to define a plurality of lumens of differing cross-sectional areas, for example, the largest of the plurality of lumens has a cross-sectional area within the range of 0.50 to 0.65 square inches.

[0087] 19A-19D show contemplated alternative implementations of the intrauterine portion 40. FIG. 19A shows a dimensional alternative to FIG. 9 with a wider head 134. FIG. 19B shows another dimensional alternative to FIG. 9 with a wider head 134 and neck 136, with the neck 136 being wider than that of FIG. 19A. The wider neck 136 can promote improved engagement with the lower uterine wall, which is typically less elastic than the fundus. FIG. 19C shows an alternative in which the inner bag 44 is disposed between the cap 204 and the base 206. A plurality of suction openings 66 can be disposed in the base 88. FIG. 19D shows an alternative in which the inner bag 44 expands radially and distally outward from the base 206. The inner bag 44 can be initially located within the cavity 208 and exposed above the base 206 upon deployment.

[0088] 20A-20C show contemplated alternative implementations of the cervical portion 42. FIG. 20A shows an inner bag 142 configured to be inflated by a fluid. FIG. 20B is configured to be self-expanding by including a compression body 210 within a casing 212. The compression body 210 can be formed from foam or another suitable material. The compression body 210 is configured to be squeezed and allow expansion due to the ingress of air upon release of the input. A valve, such as a stopcock, can be provided to prevent further expansion of the compression body 210 in a desired dimension. FIG. 20C shows a squeeze bulb formed from a resiliently flexible material. The squeeze bulb is configured to be squeezed and expand to its original shape upon release of the input. The valve can prevent further expansion of the squeeze bulb in a desired dimension. FIG. 20D shows a seal 120 coupled to a housing 216. An actuator 218 can be coupled to the housing 216 and can be configured to receive input to move the intrauterine portion 40 relative to the seal 120 by sliding the conduit 36 ​​(to which the intrauterine portion 40 is coupled) relative to the housing 216.

[0089] 21, the device 32 may include at least one sensor 220 arranged for wired or wireless communication with a processor or controller 222. The sensor 220 may be located in the intrauterine portion 40 or the cervical portion 42, or both. The sensor 220 is configured to generate and transmit a signal to the controller 222 for determining the force exerted by the device 32 on the uterine wall. This avoids the need to rely on vacuum level readings for a potentially less accurate determination of the degree of engagement between the device 32 and the uterus.

[0090] The sensor 220 may be a number of sensors disposed around the outer body 58 of the intrauterine portion 40. The sensor 220 may be a contact sensor, a force sensor, a displacement sensor, or the like. The contact sensor may be configured to transmit a contact signal to the controller 222 or an output device, the signal indicating that the head 134 is in contact with the uterine wall. In the case of manual deployment of the intrauterine portion 40, the contact signal may be displayed on the output device to inform the user that the outer surface is engaging the uterine wall. In an alternative arrangement, the system 30 may include a pump 214 in communication with the controller 222, the controller 222 configured to operate the pump 214 to deploy the intrauterine portion 40 until a contact signal is received. Additionally or alternatively, the force sensor may be configured to transmit a force signal to the controller 222 indicative of the magnitude of the force exerted by the device 32 on the uterine wall, and thus the force exerted by the device 32 on the uterine wall. Exemplary force sensors include strain gauges, load cells, among others. Additionally or alternatively, the displacement sensor may be configured to transmit a displacement signal to the controller 222 indicative of the extent of expansion of the intrauterine portion 40. If desired, as the uterus contracts, the extent of expansion of the intrauterine portion 40 may be output to an output device to indicate an improvement in the patient's condition. The sensor 220 and controller 222 may facilitate operation of the tamponade and suction based therapy in the independent or co-dependent manner described above. It is further contemplated that the sensor 220 is optional and characteristics of the operation of the device 32 may also be obtained by other means, such as electronic sensing and feedback of the medical waste collection system.

[0091] Additionally or alternatively, the user can selectively set one of the magnitude of expansion and the vacuum level, while the other is automatically controlled by a control protocol stored in memory in communication with the controller. Furthermore, the user can select a pre-programmed control protocol stored in memory in communication with the controller, and the controller can control the magnitude of expansion and the vacuum level accordingly. An exemplary method includes adjusting the vacuum level as the inner bag 44 contracts (i.e., the magnitude of expansion of the intrauterine portion 40 is reduced). For example, when the intrauterine portion 40 is fully expanded, a higher or lower vacuum level can be indicated based on the induced contractions. As the inner bag 44 contracts with the contracting uterus and the intrauterine portion 40 "shrinks," the vacuum level can be increased or decreased by a predetermined or selected amount. In another example, the vacuum level can be maintained while the inner bag 44 is contracted by fixed or variable amounts at fixed or variable intervals.

[0092] Certain aspects of the present disclosure will be described with reference to the following exemplary clauses.

[0093] Clause 1 - A device for treating a uterus, comprising: a conduit defining a suction path and an inflation path; and an inner bag coupled to the conduit, the inner bag defining a first volume in fluid communication with the inflation path, the conduit defining a suction port exterior to the inner bag, the suction port in fluid communication with the suction path.

[0094] Clause 2 - The device described in Clause 1, wherein the outer surface of the inner bag further comprises a spacer mechanism configured to maintain separation between the inner bag and the uterus.

[0095] Clause 3 - A device described in clause 1 or 2, wherein the suction port is located proximal to the base of the inner bag or distal to the tip portion of the inner bag.

[0096] Clause 4 - The device of clause 3, wherein the conduit further defines an inflation port located distal to the suction port and distal to the base of the inner bag.

[0097] Clause 5 - A device for treating a uterus, comprising: a conduit defining a suction pathway; and an outer body defining a volume in fluid communication with the suction pathway, the outer body having an outer surface defining a plurality of suction openings in fluid communication with the volume, the conduit defining a suction port exterior to the inner bag, the suction port in fluid communication with the suction pathway.

[0098] Clause 6 - A device for treating a uterus, comprising: a conduit defining a suction pathway and an inflation pathway, an inner bag defining a first volume in fluid communication with the inflation pathway, and an expandable outer body defining a plurality of suction ports in fluid communication with the suction pathway, wherein a channel is defined between an inner surface of the outer body and an outer surface of the inner bag, the channel providing fluid communication between the plurality of suction ports and the suction pathway.

[0099] Clause 7 - The device described in Clause 6, further comprising a strut coupled to at least one of the inner surface of the outer body or a spacer mechanism integrally formed with the inner surface of the outer body, the strut or spacer mechanism defining a channel.

[0100] Clause 8 - A device as described in Clause 7, wherein the strut or spacer mechanism comprises a plurality of protrusions defining channels between the protrusions and opposing protrusions configured to maintain separation between the inner bag and the outer body such that bodily fluids are drawn through the multiple suction ports and into the suction path.

[0101] Clause 9 - A device described in clause 7 or 8, wherein the struts define a plurality of holes aligned with a plurality of suction ports in the outer body.

[0102] Clause 10 - The device of clause 9, wherein the plurality of holes are located within the channel.

[0103] Clause 11 - A device described in any one of clauses 7 to 9, wherein the struts are oriented longitudinally along the inner surface of the outer body.

[0104] Clause 12 - A device described in any one of clauses 7 to 10, wherein a distal portion of each of the plurality of struts is pre-formed with a bend so as to flare (spread) radially inward.

[0105] Clause 13 - A device described in any one of clauses 7 to 12, wherein the outer body is overmolded onto the struts, and optionally, the struts are not otherwise directly connected to another subcomponent of the device.

[0106] Clause 14 - A device described in any one of clauses 7 to 13, wherein the struts further comprise at least three struts radially and equiangularly spaced around the conduit.

[0107] Clause 15 - A device for treating a uterus, comprising: a conduit defining an inflation pathway; a distal cap movably disposed to cover a distal portion of the conduit; and an inner bag including a base portion coupled to the conduit and a tip portion coupled to the distal cap, the inner bag defining a volume in fluid communication with the inflation pathway, the distal cap configured to move distally along the distal portion of the conduit in response to fluid being directed from the inflation pathway into the volume causing the inner bag to expand.

[0108] Clause 16 - The device described in Clause 15, wherein the conduit defines a suction path separate from the inflation path, the device further comprising an outer body coupled to the conduit and positioned to at least partially cover the inner bag, the outer body defining a plurality of suction ports, and a second volume defined between the inner bag and the outer body being fluidly connected to the suction path of the conduit and the plurality of suction ports.

[0109] Clause 17 - A device described in Clause 15 or 16, wherein the distal cap comprises a body portion and a cap head extending distally from the body portion, the outer diameter of the cap head being smaller than the outer diameter of the body portion, and the distal portion of the inner bag being connected to the cap head.

[0110] Clause 18 - The device described in clause 17, wherein the body of the distal cap defines a cavity sized to receive a distal portion of the conduit.

[0111] Clause 19 - A device as described in clause 17 or 18, wherein the cap head has a blunt distal end.

[0112] Clause 20 - A device for treating a uterus, comprising: a conduit defining a suction pathway and an inflation pathway; an inner bag coupled to the conduit, the inner bag defining a volume in fluid communication with the inflation pathway; an outer body defining a suction port in fluid communication with the suction pathway; and a collar coupled to the conduit, wherein a base of the outer body is coupled to the collar at a location proximal to where the inner bag is coupled to the conduit.

[0113] Clause 21 - A device as described in clause 20, wherein a base of the inner bag is spaced apart from the conduit.

[0114] Clause 22 - A device as described in clause 20 or 21, wherein the conduit has a non-flexible distal end and the conduit is fixedly attached to the collar to provide stacking of the sub-components, thereby preventing buckling of the intrauterine portion while the device is inserted while being grasped by the collar.

[0115] Clause 23 - A device described in any one of clauses 20 to 22, further comprising an expandable cervical seal coupled to the collar and the conduit.

[0116] Clause 24 - A device described in any one of clauses 20 to 23, wherein the collar defines an additional plurality of suction ports in fluid communication with the suction pathway.

[0117] Clause 25 - A device as described in clause 23 or 24, wherein the collar comprises a flange defining an additional plurality of suction ports, and the inner bag and cervical seal are joined on either side of the flange.

[0118] Clause 26 - The device of clause 25, wherein the ridge comprises a visual indicia configured to facilitate (facilitate) insertion of the collar into a position within the cervix.

[0119] Clause 27 - The device described in Clause 26, wherein the visual indicia is a first color and the cervical portion comprises a sealant, the sealant comprising the visual indicia and / or formed from a material of a second color.

[0120] Clause 28 - A device described in any one of clauses 23 to 27, wherein the collar includes a barrier between the outer body and the cervical seal.

[0121] Clause 29 - The device described in Clause 28, wherein the conduit further defines a first inflation port located distal to the barrier and a second inflation port located proximal to the barrier.

[0122] Clause 30 - A device for treating a uterus, comprising: a conduit defining an inflation path and a second inflation path; an inner bag coupled to the conduit, the inner bag defining a first volume in fluid communication with the inflation path; an outer body defining the second volume; and a cervical seal coupled to the conduit, the cervical seal having a sidewall defining a third volume in fluid communication with the second inflation path, wherein the sidewall is of variable (varying) thickness.

[0123] Clause 31 - A device as described in Clause 30, wherein the proximal portion of the side wall is thicker than the distal portion of the side wall, and the proximal and distal portions are separated by a point of maximum radial expansion of the cervical seal in the inflated state.

[0124] Clause 32 - A device as described in clause 30 or 31, wherein the proximal portion is coupled to the conduit and configured to extend (spread) radially in the proximal direction around the conduit.

[0125] Clause 33 - A device described in any one of clauses 30 to 32, wherein the inner bag has a tip portion formed with a variable (varying) thickness.

[0126] Clause 34 - A device for treating a uterus, comprising an intrauterine portion defining a second volume and defining a plurality of suction openings in communication with the second volume, the intrauterine portion being formed from a resilient material having material properties configured to provide columnar strength for handling the device at or near a proximal end of the device for collapsible insertion of the intrauterine portion into the uterus through a cesarean section or through the cervix, and further configured to return to an original shape.

[0127] Clause 35 - The device described in clause 34, wherein the material properties are further configured to provide an intrauterine portion that deforms to conform to the contour of the uterus from resistance from the uterine wall.

[0128] Clause 36 - A device described in any one of Clauses 34 or 35, wherein a plurality of suction openings are arranged in fluid communication with a vacuum source and configured to draw a vacuum within the uterus to induce uterine contractions.

[0129] Clause 37 - A device described in any one of clauses 34 to 36, wherein the intrauterine portion is configured to be deployed to an expanded configuration within the uterus.

[0130] Clause 38 - The device described in Clause 37, wherein the intrauterine portion further comprises an outer body and an inner bag disposed within the outer body, the inner bag being disposed in fluid communication with a fluid source and configured to receive fluid to cause the intrauterine portion to be in an expanded configuration.

[0131] Clause 39 - A device as described in Clause 38, wherein the second volume is defined between the outer body and the inner bag.

[0132] Clause 40 - A device as described in Clause 39, wherein the inner bag has a proximal end opposite the distal end, and the device further comprises a conduit extending at least partially through the intrauterine portion, the conduit defining a suction port located axially within the outer body proximal to the proximal end of the inner bag to further define a suction path.

[0133] Clause 42 - The device described in Clause 41, wherein the conduit further defines a distal suction port located axially within the outer body distal to the distal end of the inner bag to further define a suction path.

[0134] Clause 43 - A device described in any one of clauses 34 to 42, wherein the intrauterine portion, in the expanded configuration, has an expanded width that is greater than the original width of the intrauterine portion, and optionally the intrauterine portion, in the expanded configuration, has an extended length that is greater than the original length of the intrauterine portion.

[0135] Clause 44 - A device for treating uterine bleeding, comprising an intrauterine portion configured to provide for collapsible insertion of the intrauterine portion into the uterus through a cesarean section or through the cervix and further configured to return to an original shape, the intrauterine portion including: an outer body defining a plurality of suction openings; an inner bag disposed within the outer body and having a proximal end opposite a distal end; and a conduit extending at least partially through the intrauterine portion, the conduit defining a proximal suction port located within the outer body proximal to the proximal end of the inner bag.

[0136] Clause 45 - The device described in Clause 44, wherein the conduit further defines a distal suction port located within the outer body axially distal to the distal end of the inner bag.

[0137] Clause 46 - A device for treating uterine bleeding, comprising an intrauterine portion configured to be inserted into a uterus, the intrauterine portion comprising an outer body and an inner bag disposed within the outer body, the inner bag being disposed in fluid communication with a fluid source and configured to receive fluid to place the intrauterine portion in an enlarged configuration, in which the intrauterine portion expands axially to an extended length and further expands radially to an enlarged width.

[0138] Clause 47 - The device described in Clause 46, wherein the inner bag further comprises a plurality of inner bags, each inner bag being configured to be separately inflatable to impart a desired profile to the outer body of the internal uterine portion.

[0139] Clause 48 - A device as described in Clause 46 or 47, wherein the intrauterine portion defines a plurality of suction openings communicating with a suction path defined between the inner surface of the outer body and the inner bag, the plurality of suction openings being arranged in fluid communication with a vacuum source and configured to draw a vacuum within the uterus to induce uterine contractions.

[0140] Clause 49 - A device described in any one of clauses 46 to 48, wherein the intrauterine portion is spherical and further comprises a head, a neck extending proximally from the head and tapering radially inward, and a crown extending distally from the head and tapering radially inward to define a blunt end of the device.

[0141] Clause 50 - A device described in any one of clauses 46 to 49, wherein the outer surface of the intrauterine portion defines a recess and the multiple suction openings are disposed within the recess.

[0142] Clause 51 - The device according to clause 50, wherein the plurality of suction openings are equally spaced within the recess.

[0143] Clause 52 - A device described in Clause 50 or 51, wherein the recess is oriented longitudinally along the intrauterine portion.

[0144] Clause 53 - A device described in any one of clauses 46 to 52, wherein the recess comprises a plurality of recesses, optionally the plurality of recesses being radially and equiangularly spaced around the intrauterine portion.

[0145] Clause 54 - A device for treating uterine bleeding, comprising: an intrauterine portion configured to be deployed within a uterus, the intrauterine portion having an outer surface oriented radially outwardly, the outer surface configured to directly contact uterine tissue to provide tamponade, the outer surface defining a plurality of suction openings, the plurality of suction openings disposed in fluid communication with a vacuum source and configured to draw a vacuum within the uterus to induce uterine contractions.

[0146] Clause 55 - A device as described in Clause 54, wherein the intrauterine portion defines a recess and the multiple suction openings are disposed within the recess.

[0147] Clause 56 - The device according to clause 55, wherein the plurality of suction openings are equally spaced within the recess.

[0148] Clause 57 - A device described in Clause 55 or 56, wherein the recess is elongated and oriented longitudinally along the intrauterine portion.

[0149] Clause 58 - A device described in any one of clauses 55 to 57, wherein the multiple recesses are radially (diametrically) equiangularly spaced around the intrauterine portion.

[0150] Clause 59 - A device described in any one of clauses 55 to 58, wherein the multiple recesses are arranged radially (diametrically) asymmetrically around the intrauterine portion.

[0151] Clause 60 - A device described in any one of clauses 55 to 59, wherein the intrauterine portion is spherical and further comprises a head and a neck extending proximally from the head and tapering radially inward, and wherein a recess is disposed in each of the head and the neck.

[0152] Clause 61 - A device described in any one of clauses 55 to 60, wherein the distal end of each of the multiple recesses terminates before the distal end of the intrauterine portion.

[0153] Clause 62 - A connector for connecting two conduits each including at least three fluid paths, the connector comprising: a female component comprising: an end wall; at least one fitting extending from the end wall to define a first end of the female component; an outer wall extending from the end wall to define a second end of the female component; a first inner wall coaxially disposed within the outer wall and extending from the end wall a distance less than a distance the outer wall extends from the end wall; and a second inner wall coaxially disposed within the first inner wall and extending from the end wall a distance less than a distance the first inner wall extends from the end wall, the outer wall defining a first cavity, the first inner wall having a first inner diameter defining a second cavity within the first cavity, and the second inner wall having a second inner diameter defining a third cavity within the second cavity.

[0154] Clause 63 - The connector of clause 62, further comprising a male component configured to be removably coupled to the female component, the male component comprising a first section having a first outer diameter sized to be received within a first cavity of the female component, a second section arranged coaxially with respect to the first section, the second section having a second outer diameter sized to be received within a second cavity of the female component, and a third section arranged coaxially with respect to the second section, the third section having a third outer diameter sized to be received within a third cavity of the female component, wherein the first section comprises at least one fitting and defines a first offset hole configured to be disposed in fluid communication with the first cavity of the female component, the second section defines a second offset hole configured to be disposed in fluid communication with the second cavity of the female component, and the second section defines a central hole disposed in fluid communication with the first cavity of the female component.

[0155] Clause 64 - A coupler as described in Clause 63, wherein at least one fitting of the male component further comprises a first fitting in fluid communication with the first offset hole and a second fitting in fluid communication with the second offset hole.

[0156] Clause 65 - A coupler as described in clause 64, wherein a face of the male component defines a non-circular opening between the first fitting and the second fitting, the non-circular opening being in fluid communication with the central bore.

[0157] Clause 66 - The coupler of any one of Clauses 63 to 65, further comprising a first seal coupled to the first section, a second seal coupled to the second section, and a third seal coupled to the third section.

[0158] Clause 67 - A coupler described in any one of Clauses 61 to 64, wherein at least one fitting of the female component further comprises a first lateral fitting in fluid communication with the first cavity, a second lateral fitting in fluid communication with the second cavity, and a third central fitting in fluid communication with the third cavity.

[0159] Clause 68 - A coupler as described in clause 67, wherein the third central mounting is larger than the first and second lateral mountings.

[0160] Clause 69 - A system for treating a uterus, comprising: a device and a control hub, wherein the device comprises a conduit defining a suction path, a first inflation path, and a second inflation path; an inner bag defining a first volume in fluid communication with the inflation paths; an expandable outer body arranged to at least partially cover the inner bag such that a second volume defined between the inner bag and the outer body is in fluid communication with the suction path of the conduit; and a cervical seal defining a third volume in fluid communication with the second inflation path, wherein the control hub comprises a vacuum valve configured to be positioned in fluid communication with the suction path of the conduit; a first inflation valve configured to be positioned in fluid communication with the first inflation path of the conduit; and a second inflation valve configured to be positioned in fluid communication with the second inflation path of the conduit.

[0161] Clause 70 - The system described in Clause 69, further comprising: a first switch operably coupled to the vacuum valve, the first switch configured to receive a first input for actuating the vacuum valve to allow or prevent suction from the vacuum source from being drawn into the second volume; and a second switch operably coupled to the expansion valve, the second switch configured to receive a second input for actuating the expansion valve to a closed position to maintain expansion of the inner bag with fluid in the first volume.

[0162] Clause 71 - The system described in clause 69 or 70, wherein the expansion valve comprises a self-sealing fitting configured to be coupled to a source of expansion fluid.

[0163] Clause 72 - A system for treating uterine bleeding, comprising: an intrauterine portion having a head configured to be deployed in an expanded configuration within the uterus; a cervical portion coupled to the intrauterine portion and comprising a seal; and a controller configured to receive data or signals indicative of a status of the intrauterine portion deployed within the uterus, wherein in the expanded configuration the head expands to contour to the shape of the uterus to provide tamponade.

[0164] Clause 73 - The system described in Clause 72, further comprising a sensor in communication with the controller and configured to generate data or a signal to be transmitted to the controller, the sensor being at least one of a contact sensor, a force sensor, a pressure sensor, a flow sensor, an optical sensor, a temperature sensor, and a displacement sensor configured to transmit a signal to the controller.

[0165] Clause 74 - The system described in clause 73, wherein the sensor is placed in the intrauterine portion.

[0166] Clause 75 - A system described in any one of clauses 72 to 74, wherein the intrauterine portion further comprises a radio (X-ray) opaque marker configured to facilitate visualization under fluoroscopy.

[0167] Clause 76 - A method of treating a uterus with a device including an intrauterine portion defining a plurality of suction openings, a cervical portion coupled to the intrauterine portion, and a conduit, the method comprising the steps of guiding the intrauterine portion through the cervix or cesarean section, positioning the cervical portion within the cervix, guiding a second inflation fluid from a second fluid source through a second inflation path of the conduit into a third volume to deploy the cervical portion into an expanded configuration against the cervix, and operating a vacuum source in fluid communication with the second volume defined between the inner bag of the intrauterine portion and the outer body through the suction path of the conduit.

[0168] Clause 77 - The method of clause 76, further comprising directing a second inflation fluid from a first fluid source through a first inflation path of the conduit and into a first volume defined by the inner bag to deploy the intrauterine portion into an expanded configuration within the uterus.

[0169] Clause 78 - A method of treating a uterus with a device including an intrauterine portion defining a plurality of suction openings, a cervical portion coupled to the intrauterine portion, and a conduit, the method comprising the steps of guiding the intrauterine portion through the cervix or cesarean section, positioning the cervical portion within the cervix, guiding a first inflation fluid from a first fluid source through a first inflation path of the conduit and into a first volume defined by an inner bag to expand the intrauterine portion into an expanded configuration within the uterus, and guiding a second inflation fluid from a second fluid source through a second inflation path of the conduit and into a third volume to expand the cervical portion into an expanded configuration relative to the cervix.

[0170] Clause 79 - The method described in Clause 78, further comprising the step of operating a vacuum source in fluid communication with a second volume defined between the inner bag of the intrauterine portion and the outer body through a suction path of the conduit.

[0171] Clause 80 - The method of any one of clauses 76 to 79, further comprising the step of connecting the device to a control hub via a connector to establish fluid communication between the suction path and the vacuum line, between the first inflation path and the first supply line, and between the second inflation path and the second supply line.

[0172] Clause 81 - The method of clause 80, further comprising the steps of coupling a first saline syringe to a second supply line, activating the first saline syringe to induce a second inflation fluid into the second supply line to expand the cervical portion, and disconnecting the first saline syringe, wherein the second supply line includes a self-sealing fitting.

[0173] Clause 82 - The method of clause 81, further comprising the step of coupling a second saline syringe to the first supply line with the first expansion valve in a closed position.

[0174] Clause 83 - The method of clause 82, further comprising the steps of actuating the second expansion valve to at least a partially open position, actuating the second syringe to direct a first expansion fluid through the first supply line to expand the intrauterine portion, and further actuating the second expansion valve to a closed position, thereby maintaining a volume of fluid within the inner bag and the intrauterine portion in an expanded configuration.

[0175] Clause 84 - A method of treating a uterus with a device including an intrauterine portion defining a plurality of suction openings and an internal bag disposed within the intrauterine portion, the method comprising the steps of inflating the internal bag with a fluid to expand the intrauterine portion within the uterus, providing a vacuum within the intrauterine portion to draw blood from within the uterus through the plurality of suction openings, and contracting the internal bag while maintaining the vacuum.

[0176] Clause 85 - The method of clause 84, further comprising adjusting the vacuum level of the vacuum based on the magnitude of expansion of the intrauterine portion within the uterus.

[0177] Clause 86 - The method of clause 85, wherein the vacuum level and / or magnitude of expansion are selectively set according to user input or a control protocol stored on the memory of the controller.

[0178] Clause 87 - A method as described in any one of clauses 84 to 86, further comprising the step of at least partially opening the first expansion valve to selectively adjust the drainage rate or contraction rate of fluid from within the inner bag based on pressure from uterine contractions.

[0179] Clause 88 - A method of manufacturing a device for treating a uterus, the device including a conduit, a collar, a distal cap, an inner bag, and an expandable outer body, the method including the steps of: positioning the collar slidably over the conduit; fixing the collar in place on the conduit; positioning the distal cap slidably over a distal portion of the conduit; fixing the inner bag to the distal cap; positioning the inner bag and the distal cap slidably over the distal portion of the conduit; fixing the inner bag to the conduit to define a first volume; positioning the outer body over (covering) the inner bag; and fixing the outer body to the collar to define a second volume between the inner bag and the outer body.

[0180] Clause 89 - The method of clause 88, wherein the device further comprises a plurality of struts, and the method further comprises the step of fixing an inner surface of the outer body to the plurality of struts.

[0181] Clause 90 - The method of clause 89, further comprising the steps of placing a plurality of struts in a jig and overmolding an outer body onto the plurality of struts.

[0182] Clause 91 - A method according to any one of clauses 88 to 90, wherein the device includes an expandable cervical seal and the method further includes a step of fixing the cervical seal to the collar and the conduit to define a third volume.

[0183] Clause 92 - The method of any one of clauses 88-91, further comprising extruding the conduit to define a plurality of lumens of differing cross-sectional areas.

[0184] Clause 93 - The method of clause 92, wherein the cross-sectional area of ​​the largest lumen among the plurality of lumens is within the range of 0.50 to 0.65 square inches.

[0185] The above disclosure is not intended to be exhaustive or to limit the invention to any particular form. The terminology used is intended to be words of description rather than of limitation in nature. Many modifications and variations are possible in light of the above teaching, and the invention may be practiced otherwise than as specifically described.

Claims

1. A device for treating the uterus, Conduits that define the suction path and the expansion path, An inner bag connected to the conduit, the inner bag defining a first volume portion that is in fluid communication with the expansion path, An expandable outer body positioned to cover at least partially the inner bag and defining a suction port, Equipped with, A second volumetric section defined between the inner bag and the outer body is in fluid communication with the suction port of the outer body and the suction path of the conduit. The conduit defines a suction port located proximal to the inner bag and in fluid communication with the suction path, and an expansion port located distal to the suction port and distal to the base of the inner bag, and in communication with the expansion path. The conduit has a distal end that is placed inside the inner bag. device.

2. The device according to claim 1, wherein the distal end is located distal to the expansion port.

3. The device according to claim 2, wherein the inner bag is not connected to the distal end.

4. The device according to claim 3, wherein the conduit is a multi-lumen tube, and an internal barrier separates each lumen, defining the suction path and the expansion path, and the size of the lumens can be optionally selected to be different.

5. The device according to claim 1, wherein the distal end comprises a base fixedly connected to seal the ends of each of the lumens.

6. The device according to claim 1, wherein the outer body comprises a spacer mechanism configured to maintain separation between the inner bag and the outer body, and when the inner bag is inflated, bodily fluids are drawn into the suction path through the second volume portion, and optionally the spacer mechanism is a protrusion integrally formed with the outer body.

7. The device according to claim 1, further comprising a strut coupled to the outer body, the strut defining a channel configured to maintain separation between the inner bag and the outer body, and in the inflated state of the inner bag, body fluid is drawn through the second volume portion into the suction path.

8. The device according to claim 7, wherein the strut defines a hole aligned with the suction port of the outer body, the hole is located within the channel, and optionally the strut is oriented longitudinally along the inner surface of the outer body.

9. The device according to claim 1, wherein the conduit defines another suction port located distal to the inner bag.

10. The device according to any one of claims 1 to 9, wherein the inner bag is formed of an elastic material configured to expand when an expanding fluid is guided through the expansion path into the first volume, and the outer body is formed of an elastic material configured to follow the expansion of the inner bag.

11. The device according to any one of claims 1 to 9, wherein the inner bag is formed of a flexible, non-elastic material configured to expand when an expanding fluid is guided through the expansion path into the first volumetric portion, and the outer body is formed of an elastic material configured to conform to the shape of the inner bag.

12. The device according to claim 1, further comprising a distal cap that is movable to cover the distal end, wherein the inner bag is coupled to the distal cap.

13. The device according to claim 12, wherein the distal end is tapered and the distal cap has a blunt tip.

14. The device according to claim 12 or 13, wherein the distal cap comprises a body and a cap head extending distally from the body, the outer diameter of the cap head being smaller than the outer diameter of the body, the distal tip portion of the inner bag being coupled to the cap head, and optionally the body of the distal cap defining a cavity sized to receive the distal end of the conduit.

15. The device according to claim 1, wherein the conduit defines a second expansion path, and the device further comprises an expandable cervical seal, the cervical seal being coupled to the conduit and defining a third volume, the third volume being in fluid communication with the second expansion path.

16. The device according to claim 15, further comprising a collar coupled to the conduit, wherein the outer body is fixedly coupled to the collar, and the collar comprises a barrier arranged to maintain fluid separation between the second volume and the third volume.

17. The device according to claim 16, wherein the collar and the cervical seal are integrally formed.

18. The device according to claim 15, wherein the conduit further defines a second expansion port located proximal to the barrier.

19. The device according to claim 16, wherein the collar defines an additional suction port that is in fluid communication with the second volumetric section and the suction path.

20. The device according to claim 15, wherein the cervical seal is formed from a side wall including an outer surface opposite to the inner surface, the side wall defines the thickness between the inner surface and the outer surface, and the thickness of the side wall differs between the two ends of the cervical seal.

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