Uterine drains, uterine drain systems, and methods for using same

Abstract

Mammalian cervixes meet the vagina at an angle of approximately ninety degrees, making it difficult to navigate instruments and, in particular, uterine drains through the cervix into a vagina. Uterine drains configured to navigate this anatomy have may incorporate removable stylets with sufficient stiffness to successfully navigate the cervical / vaginal intersection without bending, twisting, or bunching while still being flexible enough to bend as needed to enter the vagina.

Description

UTERINE DRAINS, UTERINE DRAIN SYSTEMS, AND METHODS FOR USING SAMERELATED APPLICATIONS

[0001] This application is an INTERNATIONAL (PCT) application of, and claims priority to, United States Provisional Patent Application Number: 63 / 686,115, filed on 22 August 2024 and entitled “UTERINE DRAINS, UTERINE DRAIN SYSTEMS, AND METHODS FOR USING SAME” and United States Provisional Patent Application Number: 63 / 796,922, filed on 29 April 2025 and entitled “UTERINE DRAINS, UTERINE DRAIN SYSTEMS, AND METHODS FOR USING SAME,” both of which are incorporated herein by reference in their respective entireties.BACKGROUND

[0002] Blood vessels within and / or adjacent to hollow organs may hemorrhage in response to, for example, trauma or surgery. In particular, blood vessels within a uterus may remain open and / or bleeding following delivery of a fetus, and, in some cases, postpartum hemorrhage may occur when the uterus bleeds more than OOmL of blood within the first 24 hours following caesarean delivery of a child. Often, the condition is caused when the woman’s uterus fails to contract postpartum, which leaves blood vessels within the uterus open, so they continue to bleed. Postpartum hemorrhage may lead to a significant loss of blood from, and in extreme cases death of, the woman.

[0003] Traditionally, it is difficult to diagnose and / or determine the amount of postpartum hemorrhage because it is difficult to determine or measure the volume of postpartum blood-loss, as there are inadequate means to capture the blood and accurately measure it. This is further complicated by blood pooling in the uterine cavity over time. This pooled blood may be held in place via, for example, a blood clot that forms at the base of the uterus and covers the opening to the cervical canal so that the woman may be bleeding internally (occult blood loss) with no vaginal bleeding to alert medical staff that postpartum hemorrhage may be occurring.SUMMARY

[0004] The uterine drains disclosed herein may be used to apply suction to a uterus to, for example, apply suction tamponade to the uterus (which will close open bloodvessels and staunch bleeding) and / or evacuate fluid from a patient’s uterus to, for example, quality blood loss and / or diagnose postpartum hemorrhage.

[0005] The uterine drains disclosed herein may include a tube with a first end, a second end, and a central lumen therebetween along the length of the tube. The tube may be configured to reside within a patient’s cervix and extend through and out of the patient’s vagina during use. The uterine drains disclosed herein may further include a drain extension configured to reside within the patient’s uterus during use. The drain extension may include a first end, a second end, a plurality of drainage holes, and a drain extension lumen extending between approximately the first end and the second end. The first end of the drain extension may be in communication with the first end of the tube so that the drain extension lumen may be in communication with the central lumen so that fluid entering one of the plurality of drainage holes enters the drain extension lumen for communication to the central lumen. The drain extensions may be, for example, an extension of tube (i.e., made from the same material but with the plurality of holes positioned therein) and / or a separate component bonded to the tube.

[0006] The uterine drains disclosed herein may further include a tip configured to be removably attached to, and cover, the second end of the drain extension. The tip may be attached to a stylet resident within the drain extension lumen and a portion (e.g., 10%-100%) of the central lumen. The stylet may be configured to add stiffness to the uterine drain and / or a portion thereof so that, for example, it may be manipulated by a clinician when the clinician is inserting the uterine drain into the uterus, cervix, and / or vagina prior to use. The stylet may be configured to be removed from the drain extension and the portion of the central lumen via extraction of the tip from the second end of the drain extension. This extraction may be performed via a surgical opening in the patient’s uterus, wherein the clinician extracts the tip and stylet prior to closing the uterus at the conclusion of surgery. In some embodiments, the tip may include one or more features (e.g., ridges, bumps. Indentations, etc.) that enable secure manual grasping of the tip so that it may be extracted from the drain extension upon placement of the uterine drain within the patient’s uterus.

[0007] In some embodiments, the uterine drains disclosed herein may include a tube cap extending from and / or attached to the second end of the tube. The tube cap may be sized, positioned, and configured to allow for insertion into the patient’s vagina,through the patient’s cervix, and into the patient’s uterus. At times, the tube cap may be removable from the second end of the tube via, for example, pulling the tube cap off the second end of the tube. Alternatively, the tube cap may be removed from the second end of the tube via cutting the second end of the tube, thereby exposing an open second end of the tube.

[0008] The uterine drains disclosed herein may be used by placing them in a patient’s body during pelvic surgery or cesarian section so that the drain extension may be positioned within the patient’s uterus and a portion of the tube extends from the patient’s introitus. Once in position, the stylet may be removed from the drain extension via a surgical opening in the patient’s uterus. An open end of the portion of the tube that extends from the patient’s introitus may then be coupled a source of suction or a collection vessel so that fluid that enters one or more of the plurality of drainage holes may be evacuated from the patient’s uterus via communication between the drain extension lumen and the central lumen. Additionally, or alternatively, the source of suction may apply suction tamponade to the uterus, which may encourage the uterus to contract post childbirth and, thereby, facilitate closing of open, bleeding, blood vessels. An amount of suction applied to the uterine drains disclosed herein may be within a range of 50-150mmHg.

[0009] For uterine drains with a tube cap, the tube cap may be removed (e.g., pulled out of or cut off of) the second end of the tube so that a source of suction may be coupled to the tube and be in communication with central lumen.

[0010] In an alternative embodiment, the uterine drains disclosed herein may include a tube with a first end, a second end, and a central lumen. The tube may be configured to reside within a patient’s cervix and extend through and out of the patient’s vagina during use. The uterine drains may further include a drain extension in communication with the first end of the tube. The drain extension may include a drain extension lumen in communication with the central lumen and a plurality of drainage holes and may be configured to allow fluid to enter the drain extension lumen. The uterine drains may further include a tip configured to be removably attached to, and cover, the second end of the tube, and the tip may be attached to a stylet that is resident within the central lumen and a portion of the drain extension lumen. The stylet may be configured to be removed from the central lumen and the portion of the drain extension lumen via extraction of the tip from the second end of the tube. In some embodiments, the uterine drain may include an endcap extendingfrom an end of the drain extension. The endcap may be sized, positioned, and configured to allow for insertion into the patient’s vagina, through the patient’s cervix, and into the patient’s uterus. This uterine drain may be used to evacuate fluid from a patient’s uterus when placed in the in the patient’s body so that the drain extension is positioned within the patient’s uterus and a portion of the tube extends from the patient’s introitus. Then, the stylet may be extracted from the tube and drain extension via pulling on the tip, thereby creating an open second end of the tube and a source of suction may be coupled to the open end of the tube and an amount of suction sufficient to apply suction tamponade to the patient’s uterus may be applied to the central lumen by the source of suction.BRIEF DESCRIPTION OF THE DRAWINGS

[0011] The present invention is illustrated by way of example, and not limitation, in the figures of the accompanying drawings in which:

[0012] FIG. 1 is a schematic drawing of a top view of an exemplary uterine drain, in accordance with some embodiments of the present invention;

[0013] FIG. 2 is a schematic diagram of a cross-section view of a system including the uterine drain of FIG. 1 with a stylet positioned therein, in accordance with some embodiments of the present invention;

[0014] FIG. 3 is a schematic diagram of a cross-section view of a system including the uterine drain of FIG. 1 with an elongated stylet positioned therein, in accordance with some embodiments of the present invention;

[0015] FIG. 4 is a schematic diagram of a cross-section view of a system including the uterine drain of FIG. 1 with a metal stylet positioned therein, in accordance with some embodiments of the present invention;

[0016] FIG. 5 is schematic diagram of a cross-section view of the uterine drain of FIG. 1 with a sheath positioned therein, in accordance with some embodiments of the present invention;

[0017] FIG. 6 is a schematic diagram of a cross-section view of a system that includes the uterine drain of FIG. 1 with a stylet that includes extensions positioned therein, in accordance with some embodiments of the present invention;

[0018] FIG. 7A is a schematic diagram of a cross-section view of a uterine drain system with small drainage holes and flip valves positioned proximate to each of thesmall drainage holes when the flip valves are in a closed position, in accordance with some embodiments of the present invention;

[0019] FIG. 7B is a schematic diagram of a cross-section view of the uterine drain system of FIG. 7A when the flip valves are in an open position, in accordance with some embodiments of the present invention;

[0020] FIG. 8 is a schematic diagram of a cross-section view of a system that includes the uterine drain of FIG. 1 and a guide wire, in accordance with some embodiments of the present invention;

[0021] FIG. 9A is a schematic diagram of a top view of a telescoping uterine drain when in a contracted state, in accordance with some embodiments of the present invention;

[0022] FIG. 9B is a schematic diagram of a top view of the telescoping uterine drain of FIG. 9A when in an expanded state, in accordance with some embodiments of the present invention;

[0023] FIG. 10 is a schematic diagram of a side view of an exemplary articulating uterine drain tip, in accordance with some embodiments of the present invention;

[0024] FIG. 11 A is a schematic diagram of a cross-section view of a tube with two side-wall lumens present therein, in accordance with some embodiments of the present invention;

[0025] FIG. 11 B is a schematic diagram of a cross-section view of a tube with four side-wall lumens present therein, in accordance with some embodiments of the present invention;

[0026] FIG. 11C is a schematic diagram of a cross-section view of a tube with a single side-wall lumen present therein, in accordance with some embodiments of the present invention;

[0027] FIG. 11 D is a schematic diagram of a uterine drain incorporating a tube with a first lumen and a second lumen positioned in a sidewall thereof, a first fluid line extension coupled to first lumen and a second fluid line extension coupled the second lumen, in accordance with some embodiments of the present invention;

[0028] FIG. 12A is a schematic diagrams of a side view of a uterine drain in a straight, or neutral, configuration, in accordance with some embodiments of the present invention;

[0029] FIG. 12B is a schematic diagrams of a side view of the uterine drain of FIG. 12A when a distal end thereof is in a curved, or bent, configuration, in accordance with some embodiments of the present invention;

[0030] FIG. 13A is a schematic diagrams of a side view of an exemplary embodiment of a distal portion of a tube of a uterine drain in a straight, or neutral, configuration, in accordance with some embodiments of the present invention;

[0031] FIG. 13B is a schematic diagrams of a side view of an exemplary embodiment of a distal portion of a tube of a uterine drain in a curved, or bent, configuration, in accordance with some embodiments of the present invention;

[0032] FIG. 14A is a schematic diagram of a side view of another exemplary embodiment of a distal portion of a tube of a uterine drain in a straight, or neutral, configuration, in accordance with some embodiments of the present invention;

[0033] FIG. 14B is a schematic diagram of a side view of the distal portion of FIG. 14A with a distal portion in a curved, or bent, configuration, in accordance with some embodiments of the present invention;

[0034] FIG. 15 is a schematic diagram of a top view of an exemplary uterine drain that includes a tube with a pre-set curvature, in accordance with some embodiments of the present invention;

[0035] FIG. 16 is a schematic diagram of a top view of an exemplary stylet that includes a pre-set curvature, in accordance with some embodiments of the present invention;

[0036] FIG. 17 is a schematic diagram of a cross-section view of an exemplary stylet with an asymmetrical cross-sectional shape, in accordance with some embodiments of the present invention.

[0037] FIG. 18A is a schematic diagram of a cross-section view of a tube with two stiffening and / or malleable members present in a sidewall thereof, in accordance with some embodiments of the present invention;

[0038] FIG. 18B is a schematic diagram of a cross-section view of a tube with four stiffening and / or malleable members present in a sidewall thereof, in accordance with some embodiments of the present invention;

[0039] FIG. 18C is a schematic diagram of a cross-section view of a tube with a single stiffening and / or malleable member present in a sidewall thereof, in accordance with some embodiments of the present invention;

[0040] FIG. 18D is a schematic diagram of a side view of the uterine drain system including the tube of FIGs. 18A, 18B, or 18C, in accordance with some embodiments of the present invention;

[0041] FIG. 19 is a schematic diagram of a top view of a tube with a spiraling wire present in a sidewall thereof, in accordance with some embodiments of the present invention;

[0042] FIG. 20A provides a diagram of a top view of an exemplary uterine drain with an elongated tube that terminates in a closed end without a separate and / or removable endcap or tip , in accordance with some embodiments of the present invention;

[0043] FIG. 20B provides a diagram of a top view of the uterine drain of FIG. 20A with an elongated stylet positioned within a central lumen thereof, in accordance with some embodiments of the present invention;

[0044] FIG. 20C provides a diagram of a top view of the uterine drain of FIG. 20A with the tip cut off, in accordance with some embodiments of the present invention;

[0045] FIG. 21A provides a cross-section view of a uterine drain with a stylet that has a deformable endcap positioned within central lumen thereof, in accordance with some embodiments of the present invention;

[0046] Fig. 21 B provides a cross-section view of the uterine drain of FIG. 21 A with the stylet and deformable cap positioned within central lumen thereof as the stylet is extracted from the lumen, in accordance with some embodiments of the present invention;

[0047] FIG. 22A provides a side view of an exemplary uterine drain guide, in accordance with some embodiments of the present invention;

[0048] FIG. 22B illustrates cross-section view of the guide of FIG. 22A, wherein the guide has an ovoid cross section, in accordance with some embodiments of the present invention;

[0049] FIG. 22C illustrates cross-section view of the guide of FIG. 22A, wherein the guide has a semi-circular cross section with a channel therein, in accordance with some embodiments of the present invention;

[0050] FIG. 23 provides a flowchart of a method for positioning a uterine drain that may, or may not, include a stylet within a uterus of a patient via a surgicalopening in the uterus, in accordance with some embodiments of the present invention;

[0051] FIG. 24A provides a diagram of a top view of a stylet with differential stiffness in a straight and / or neutral arrangement, in accordance with some embodiments of the present invention;

[0052] FIG. 24B provides a diagram of a top view of the stylet of FIG. 24A with a portion thereof in a bent, or angled, arrangement, in accordance with some embodiments of the present invention;

[0053] FIG. 24C provides a diagram of a top view of the stylet of FIG. 24A in a straight and / or neutral arrangement and positioned within a sheath, in accordance with some embodiments of the present invention;

[0054] FIG. 24D provides a diagram of a top view of the stylet of FIG. 24C in a bent, or angled arrangement and positioned within the sheath, in accordance with some embodiments of the present invention;

[0055] FIG. 25 provides a flowchart of a method for positioning a uterine drain that includes a stylet with differential stiffness within a uterus of a patient via a surgical opening in the uterus as may happen during a cesarean section, in accordance with some embodiments of the present invention;

[0056] FIG. 26A provides a schematic diagram of a uterine drain with a plurality of tactile features thereon, in accordance with some embodiments of the present invention;

[0057] FIG. 26B provides a schematic diagram of a uterine drain with a tactile features thereon, in accordance with some embodiments of the present invention;

[0058] FIG. 27A provides an exploded of a uterine drain configured for insertion via a surgical opening in the uterus, in accordance with some embodiments of the present invention;

[0059] FIG. 27B provides an assembled top view of the uterine drain of FIG. 27A, in accordance with some embodiments of the present invention;

[0060] FIG. 28A provides an exploded of another uterine drain, in accordance with some embodiments of the present invention;

[0061] FIG. 28B provides an assembled top view of the uterine drain of FIG. 28A, in accordance with some embodiments of the present invention;

[0062] FIG. 29A provides an exploded of another uterine drain with a stylet that is removable from a drainage portion thereof, in accordance with some embodiments of the present invention;

[0063] FIG. 29B provides an assembled top view of the uterine drain of FIG. 29A, in accordance with some embodiments of the present invention;

[0064] FIG. 29C provides a cross-section view of a tube cap of the uterine drain of FIG. 29A, in accordance with some embodiments of the present invention;

[0065] FIG. 30A provides a midsagittal cross-section view of a portion of the patient’s anatomy with a surgically open uterus and the uterine drain of FIG. 29A being inserted into the surgical opening, in accordance with some embodiments of the present invention;

[0066] FIG. 30B provides a midsagittal cross-section view of the portion of the patient’s anatomy with the surgical drain of FIG. 29A advanced through the uterus and entering the internal cervical os, in accordance with some embodiments of the present invention;

[0067] FIG. 30C is a close-up midsagittal cross-section view of the portion of the patient’s anatomy with the surgical drain of FIG. 29A with a drainage extension thereof positioned with the patient’s uterus as occurs when the uterine drain is when ready to use, in accordance with some embodiments of the present invention;

[0068] FIG. 30D provides a midsagittal cross-section view of the portion of the patient’s anatomy with the surgical drain of FIG. 29A positioned therein and a stylet being removed therefrom, in accordance with some embodiments of the present invention;

[0069] FIG. 30E provides a midsagittal cross-section view of the portion of the patient’s anatomy with the surgical drain of FIG. 29A positioned therein and an end of the tube being cut off so a central lumen thereof may be open to a source of suction and / or collection vessel, in accordance with some embodiments of the present invention; and

[0070] FIG. 30D provides a midsagittal cross-section view of the portion of the patient’s anatomy with the surgical drain of FIG. 29A being removed therefrom, in accordance with some embodiments of the present invention.

[0071] Throughout the drawings, the same reference numerals, and characters, unless otherwise stated, are used to denote like features, elements, components, or portions of the illustrated embodiments. Moreover, while the subject invention willnow be described in detail with reference to the drawings, the description is done in connection with the illustrative embodiments. It is intended that changes and modifications can be made to the described embodiments without departing from the true scope and spirit of the subject invention as defined by the appended claims.WRITTEN DESCRIPTION

[0072] The uterine drains, systems, devices, and methods disclosed herein are configured to apply negative pressure to internal surfaces of a uterus following surgery (e.g., childbirth by caesarean section, endoscopic surgery (e.g., tumor removal), and / or open surgery (e.g., a hysterotomy)) in order to, for example, contract the uterus so that, for example, it achieves a preferred size and / or blood vessels that may be open, or bleeding into the uterus, are constricted which may assist with, for example, staunching the bleeding and / or clot formation within the uterus so that hemorrhaging may be reduced and / or stopped.

[0073] The systems, devices, and methods disclosed herein may also be configured and / or used to evacuate, or drain, fluid (e.g., blood), solids (e.g., blood clots or tissue fragments) and / or gas from the uterus following surgery. At times, the fluid and / or material drained, or evacuated, from the uterus may be collected (e.g., using a metered collection bag and / or vessel with approximate volumetric markers) for quantification, which may be used by a clinician to determine whether the patient needs medical attention and / or an intervention (e.g., a blood transfusion or cauterization of a blood vessel within the uterus). Additionally, or alternatively, the fluid and / or material drained, or evacuated, from uterus may be examined to, for example, determine how many blood clots are present in the evacuated fluid / material and / or the size of the blood clots present in the evacuated fluid and / or material. In some embodiments, a flow rate of fluid or blood being evacuated from the uterus may be measured and / or evaluated to ascertain whether, for example, the patient is bleeding at a rate that may require medical attention and / or an intervention (e.g., a blood transfusion or cauterization of a blood vessel within the hollow organ and / or tissue).

[0074] In some instances, relative sizes and / or proportions of uterine drain components disclosed herein may be adjusted at the factory and / or prior to use (e.g., in the operating room) based upon the clinical need and application. For example, a component of a uterine drain may be bent, curved, elongated, configured for optionalelongation, and / or otherwise adjusted to fit clinical need and / or patient anatomy. In some embodiments, one or more components of uterine drains, stylets, and / or systems disclosed herein may be tagged and / or constructed using echogenic or other materials that may make them visible, or easily distinguishable, via an imaging technique such as ultrasound or X-ray. Additionally, or alternatively, the uterine drains disclosed herein may be configured to be cut to size prior to and / or during use so that they may be, for example, configured to fit within patient anatomy and / or be more comfortable for the patient.

[0075] The uterine drains and uterine drain systems disclosed herein may include a tube, a drain extension, and an alignment mechanism positioned approximately between them. The tube and drain extension may each include a lumen that are in communication with one another. The drain extension is configured to temporarily reside within the uterus and evacuate fluid, gas, and / or solids therefrom via one or more holes or openings present in the drain extension. The holes may be configured to have a smooth, or flat, profile to enable an atraumatic extraction of a uterine drain from the hollow organ and / or tissue. In some cases, drain extension holes may be of varying sizes to, for example, accommodate passage of clots that may be expected to form or collect at, or near, a lower portion of the uterus and / or tissue (e.g., proximate to the cervix) due to gravity. When fluids, gas, and / or solids enter one or more drainage holes of a drain extension, they may travel (via, e.g., suction and / or gravity) to the drain extension lumen and on to the tube lumen for eventual evacuation from the patient’s body.

[0076] In some embodiments, the drain extensions may include two linearly arranged sets of holes, or openings, that may be offset from one another by, for example, 180 degrees. Alternatively, the drain extensions may include three linearly arranged sets of holes, or openings, that may be offset from one another by, for example, 120 degrees. Alternatively, the drain extensions may include plurality of holes, or openings, that are arranged in a circumferential, spiral, and / or random pattern around the drain extension. In some embodiments, the holes within the drain extension may be arranged so that the structural integrity and / or columnal strength of the drain extension is maintained and / or meets minimum requirements. In some cases, the holes may be configured and / or arranged within a drain extension so that it aligns with a frontal plane of the hollow organ (e.g., uterus) and / or tissue so that, for example, when the hollow organ contracts in response to negative pressureapplied thereto via the uterine drain, interior tissue of the hollow organ may not enter and / or be pulled proximate to the holes, which may occlude the holes and / or prevent drainage therefrom. In some embodiments, an orientation of a drain extension may be adjustable so that, for example, it may be rotated by a clinician so that the drainage holes are pointed to a preferred portion of the hollow organ and / or tissue, such as an incision site.

[0077] A tube of the uterine drains disclosed herein may be configured to extend through the vagina so that it may be accessed by a clinician, coupled to a collection device (e.g., bag), and / or coupled to a source of suction or negative pressure (i.e., a vacuum pump and / or wall suction) that may suck gas, fluid, and / or solids into one or more holes of the drain extension for eventual evacuation from the uterus and body via the a tube lumen.

[0078] The alignment mechanisms disclosed herein may be configured to translate between an open and a closed, or collapsed, configuration. When in an open, or unfolded, configuration, the alignment mechanisms disclosed herein may be configured to hold a drain extension in a preferred position and / or orientation (e.g., fully inserted therein or positioned along a length of the hollow organ and / or tissue) within the hollow organ and / or tissue. For example, when a uterine drain (or drain extension thereof) is positioned within a uterus, the alignment mechanism may be positioned proximate to the internal cervical os, which may provide visual (e.g., extensions are spread out over and / or partially cover the internal cervical os) and / or tactile (e.g., pushback from the cervix) feedback to a clinician inserting the uterine drain, which may help guide insertion of the uterine drain and / or indicate that the uterine drain is in a proper position within the uterine cavity. At times, the alignment mechanism may also prevent the drain extension from undesirably sliding into the cervical and / or vaginal canal. Additionally, or alternatively, the alignment mechanisms disclosed herein may be configured to reduce movement of the uterine drain, or components thereof, when the drain extension is positioned within the hollow organ and / or tissue. This may reduce irritation and tissue damage that may be caused by movement of the uterine drain when positioned and / or used within the uterus of the patient. At times, the alignment mechanism may be weighted to, for example, use gravity to hold the alignment mechanism at a lowest point of the uterus (e.g., proximate to the internal cervical os).

[0079] When transitioning to a closed state, components (e.g., extensions) of an alignment mechanism may be configured to bend, fold, or collapse, to reduce the cross-sectional area of the extensions / alignment mechanism. For example, in some embodiments, one or more components of an alignment mechanism may fold, or translate, toward the drain extension so that a diameter of the alignment mechanism is reduced to achieve a streamlined profile for the uterine drain, which may reduce trauma caused to tissue when the uterine drain is extracted from the patient’s uterus when it is pulled through the cervix and vagina. In many embodiments, the alignment mechanism may translate to a collapsed state that has a relatively smooth or ridge-free exterior surface thereby assisting with extraction of the uterine drain and reducing trauma to surrounding tissue with the uterine drain is extracted.

[0080] In some cases, the uterine drains disclosed herein may be inserted into and / or placed within a uterus via a surgical incision therein and a portion of the uterine drain may be arranged to extend away from the uterus and exit the body via the vagina, thereby providing an exit channel for draining fluid away from the uterus following, for example, surgery or trauma. For example, a uterine drain may be placed within a uterine cavity via a uterine incision (hysterotomy) at the conclusion of pelvic surgery following, for example, childbirth via caesarian section. The uterine drain may be placed by threading it through the uterine cavity, cervical canal, vaginal canal, and out the introitus, thereby making a distal end accessible outside of the body so that, for example, it may be coupled to a suction source.

[0081] In some circumstances, a placed uterine drain may remain in the patient’s uterus for a period of time (e.g., 5-120 minutes) prior to be coupled to a source of suction and / or drainage device. Various mechanisms are disclosed herein to prevent and / or mitigate clot formation on a portion of the drain resident within a patient’s uterus during this period of time. Additionally, or alternatively, various uterine drain embodiments disclosed herein are configured to assist with navigation of portions a uterine drain through patient anatomy (i.e., through the uterus, cervix, and vagina) and, in particular to navigate the sharp approximately ninety-degree curve between the cervical canal and the entrance to the vagina proximate to the external cervical os.

[0082] The stylets disclosed herein may be configured to provide stiffness to, and enhance the maneuverability of, the uterine drains disclosed herein upon insertion into patient anatomy. In particular, the stylets disclosed herein may besized, configured, and / or arranged within the uterine drains disclosed herein to allow for navigation through the cervix and into the vagina (or through the vagina into the cervix), which is oriented at angle from the cervix proximate to the external cervical os. Stated differently, the stylets disclosed herein may be configured to allow the uterine drains disclosed herein to change the direction as they navigate the transition from the cervix to the vaginal (or the transition from the vagina to the cervix) without kinking, bunching, bending, twisting, or looping around.

[0083] Turning now to the figures, FIG. 1 is a schematic drawing of a top view of an exemplary uterine drain 100 that includes a drain extension 110, an alignment mechanism 120, a tube 130, and a tip, or cap, 140. Drain extension 110 includes a plurality of drainage holes and may be configured to reside within a patient’s uterus during use so that fluids and / or air may be pulled into the drainage holes and evacuated from the uterus via tube 130, which may be coupled to a source of suction (e.g., vacuum pump). Tube 130 may be configured so that it may enter the uterus via a hysterotomy and be guided and / or pushed through the patient’s cervix and vagina until tip 140 and a portion of tube 130 extends from the patient’s introitus.Once uterine drain is position, tip 140 may be removed and the corresponding end of tube 130 may be coupled to a source of suction. In some embodiments, tip 140 may be attached to tube 130 via a mechanical coupling device like threads for a screw, a ridge and / or other engagement mechanism locking tip 140 in place within tube 130 until sufficient force and / or mechanical disengagement (e.g., rotating tip 140 to disengage the threads) is applied by the clinician to remove it. Alignment mechanism 120 may be configured to reside within the uterus proximate to the patient’s internal cervical os and may be of a size, shape, and / or configuration that prevents accidental movement of uterine device 100 within the uterus and / or decent through the cervical canal into the vagina. In some embodiments, a size, circumference, and / or diameter of alignment mechanism 120 may be adjustable via, for example, pulling or pushing a component of alignment mechanism 120 to a desired length and / or size and / or turning a mechanism that adjusts the size, circumference, and / or diameter of alignment mechanism 120.

[0084] At times, the uterine drains disclosed herein may include a stylet or introducer sized, shaped, and / or configured to reside within a portion of tube 130 and assist with placement of a uterine drain within patient anatomy by, for example, providing stiffness to tube 130 and / or drain extension 110 which may assist withenabling the navigation of the uterine drain through patient anatomy, particularly as it exits the external cervical os and enters the vagina, which is oriented approximately orthogonal to the cervical canal. One example of a such a stylet is provided by FIG. 2, which is a schematic diagram of a cross-section view of a system 200 of uterine drain 100 with a stylet 250 positioned within a central lumen 135 of tube 130. In some embodiments, central lumen 135 may extend through drainage extension 130 as shown. Stylet 250 may be flexible enough to allow system 200 to bend as it is being fed through patient anatomy while still providing compressive stiffness so that it may be manipulated by a clinician (typically a surgeon) during placement without folding and / or kinking of tube 130. Stylet 250 may be attached to tip 140 so that when tip 140 is removed, stylet 250 is extracted from uterine device 100.

[0085] FIG. 3 provides a schematic diagram of a system 300 that includes uterine drain 100 and an elongated stylet 350 that extends the length of tube 130 and drain extension 110 and is coupled to an optional first cap 160A. Once system 300 is in position within a patient (e.g., with the end of tube 130 extending from the patient’s introitus), a clinician may pull elongated stylet 350 and / or optional first cap 160A out of drain extension 130 so that cap 160A and elongated stylet 350 may be pulled from uterine drain 100 and extracted from the patient via the hysterotomy. Optionally, system 300 may include a cover 165 that may be positioned on an end of system 300 opposite to first cap 160A. Cover 165 may be configured to cover an end of tube 130 and stylet 350 and may be configured for removal following placement of system 300 within a patient so that a lumen of tube 130 may be opened for coupling to a drainage container and / or a source of suction. Cover 165 may be permanently or removably affixed to tube 130. When it is permanently affixed to tube 130, it may be removed by cutting it off from tube 130.

[0086] FIG. 4 provides a schematic diagram of a cross-section view of a system 400 that uterine drain 100, and a metal stylet 450 comprising flexible metal. Metal stylet 450 extends the length of tube 130 and drain extension 110 and is coupled to a second cap 160B that may be configured as a handle for a clinician’s easy use and / or extraction of metal stylet 450 from uterine drain 100 once uterine drain 400 is in position. Once the clinician pulls second cap 160B out of drain extension 130, metal stylet 450 may be pulled from uterine drain 100 and extracted from the patient via the hysterotomy and tube, which may open a lumen of tube 130 and / or drainextension 110 so that fluid, gas, and other materials may be evacuated from the uterus via tube 130, which may be coupled to a source of suction.

[0087] FIG. 5 is a schematic diagram of a system 500 that includes uterine drain 100 with a sheath 510 resident therein. Internal sheath 510 may be configured to run through a portion of drain extension 110 and tube 130 and be coupled to tip 140 and obscure drainage holes of drain extension 110 so that, for example, any blood clots or other materials that may collect on an exterior surface of drain extension 110 while it is positioned with a patient’s uterus but not coupled to a drainage container and / or suction do not enter and / or obscure the central lumen of drain extension 110. When it is time for uterine drain to begin evacuating fluid and other materials from the patient’s uterus (e.g., upon leaving the operating room, when in a recovery room, when in a standard hospital room) tip 140 may be extracted from tube 110 and removal of tip 140 from tube 130 may also act to draw sheath 510 (which is coupled to tip 140) from drain extension 110 and tube 130 so that drainage holes may be opened and blood and other fluids may flow into the drainage holes for evacuation from the body.

[0088] In some embodiments, it may be necessary to clean a uterine drain while in position to, for example, remove clots and / or other obstructions that may clog drainage holes prior to, or during, use. One manner in which the uterine drain may be cleaned while in situ is to flush the drain with a flushing agent (e.g., saline) that may act to dissolve and / or dislodge occlusions that may form on and / or be collected near drainage holes of drain extension 110. Another exemplary manner of cleaning a uterine drain while in situ is provided by FIG. 6, which is a schematic diagram of a cross-section view of a system 600 of uterine drain 100 with a stylet 650 that includes one or more extensions 610 positioned thereon. Extensions 610 may be configured to, for example, engage and / or abut an interior side of drainage extension 110 and / or tube 130 so that, for example, fluids, clots, and other materials may be pulled from and / or cleaned out of uterine drain 100 when stylet 630 is moved within a lumen thereof and / or removed from uterine drain 100. Extension 610 may comprise, for example, a balloon, a soft material like silicon configured as a squeegee, and / or fibers that extend from stylet 650 in a manner similar to a pipe cleaner. In some embodiments a portion of an extension 610 may extend through drainage holes thereby preventing clots from forming in the drainage holes prior to coupling the uterine drain to suction. Once uterine drain 600 is in position within a patient andready to couple to suction and / or a drainage container, a clinician may pull stylet 650 through drain extension 110 and tube 130 to remove any debris from the drainage holes prior to coupling tube 130 end to suction, thereby opening the drainage holes.

[0089] FIGs. 7A and 7B are schematic diagrams of a cross-section of a uterine drain 700 in a closed and an open configuration, respectively. Uterine drain 700 includes a drain extension 710 with a plurality of small drainage holes 730 and a corresponding plurality of flip valves 720, alignment mechanism 120, tube 130, and tip 140. Flip valves 720 may be configured to cover corresponding small drainage holes 730 when in a neutral, closed configuration (FIG. 7A) and may flip open, or fall below, small drainage holes 730 when suction is applied to tube 130 and, by extension, drain extension 710 so that fluid may enter small drainage holes 730 for evacuation from the uterus.

[0090] Small drainage holes 730 may be configured to have an ovoid shape so that they are longer than they are wide as shown in FIG. 7B. This shape may allow flip valves 720 to be narrow enough to cover each respective small drainage hole 730 while still not touching an interior surface of drain extension 710 so that flip valves 710 do not adversely obscure a pathway for fluids entering small drainage holes 720 as they travel through drainage component and out tube 130 for evacuation from the patient’s uterus and body.

[0091] FIG. 8 is a schematic diagram of a cross-section of a system 800 of uterine drain 100 and a guide wire 810. Guide wire 810 may be configured to facilitate guiding system 800 through patient anatomy so that guide wire extends through the patient’s introitus and may be used to guide system 800 through the vagina so that tip 140 and a portion of tube 130 may extend through the introitus, tip 140 may be removed, and an exposed end of tube 130 may be coupled to suction.

[0092] FIGs. 9A and 9B are schematic diagrams of a top view of a telescoping uterine drain 900 that includes drain extension 110, alignment mechanism 120, tip 140, a first tube 930 that fits within a second tube 935 as shown in FIG. 9A. First tube 930 is configured to be pulled out of and / or extend away from second tube 935 thereby making a longer, extended tube configured to extend beyond the patient’s introits.

[0093] FIG. 10 is a schematic diagram of a side view of an articulating tip 1040 that may be used in place of, for example, tip 140 for any of the uterine drain embodiments disclosed herein. Articulating tip 1040 includes a plurality (in this case,five) of segments of decreasing size from top to bottom (as oriented in FIG. 10). The segments are held together by a central connecting member or strut. The strut may be configured to be flexible so that segments may articulate back and forth (e.g., left to right or front to back, as oriented in FIG. 10) and a shape of the segments may control a degree to which tip curves or articulates.

[0094] FIG. 11A provides a cross-section view of an exemplary tube 1130A of a uterine drain with a first and a second lumen 1110 in a sidewall thereof. Tube 1130A may be used in place of tube 130 in any of the embodiments disclosed herein. First and second lumens 1110 may be approximately 180 degrees in opposition to one another and may be configured for acceptance of a fluid (e.g., gas, air, saline, water, etc.) therein via, for example, a coupling 1130 as shown in FIG. 11 D, which provides a schematic diagram of a uterine drain incorporating tube 1130A with a first and a second fluid line extension 1120 coupled respectively to first and second lumens 1110 and configured for communication of a fluid from first or second coupling 1130 to and / or from respective first or second extension 1120 and respective first or second lumen 1110. A level and / or pressure of the fluid within first and / or second lumens 1110 may be proportional to a level of rigidity / flexibility for tube 1130 and may be tuned when navigate tube 1130A through a patient’s cervix and vagina to optimize insertion of tube 1130A and / or a uterine drain including tube 1130A. In some embodiments, a pressure of the fluid within first and second lumens 1110 may be the same and, in other embodiments, it may be different.

[0095] FIG. 11 B provides a cross-section view of an exemplary tube 1130B with first lumen 1110, second lumen 1110, a third lumen 1110, and a fourth lumen 1110 in a sidewall thereof. Third and fourth lumens 1110 may be positioned approximately 180 degrees in opposition to one another and approximately 90 degrees from first and second lumens 1110. Third and fourth lumens 1110 may be configured to operate in a manner similar to first and second lumens 1110. FIG. 11 C provides a cross-section view of an exemplary tube 1130C with only one lumen 1110.

[0096] In some embodiments, first, second, third, and / or fourth lumens 1110 may be configured to house a tensioning wire and / or pull string 1220 that is, for example, coupled to tip 140 and / or an end of tube 1130A and extends through first or second lumen and exits tube 1130A as shown in FIGs. 12A and 12B, which are schematic diagrams of a uterine drain system 1200 in a straight, or neutral, configuration and abent, or curved, configuration, respectively. To bend, or curve, a portion of tube 1130A proximate to tip 140, one or both pull strings 1220 may be pulled and / or pushed by an operator (typically a surgeon) via a handle 1230. Pulling pull string 1220 out of a lumen 1110 may act to pull a respective portion of tube 1130A away from the straight, or neutral, orientation, thereby bending it from its neutral state as shown in FIG. 12B.

[0097] FIGs. 13A and 13B are schematic diagrams of a portion of a uterine drain system 1300, and in particular a portion of uterine drain system showing a distal end of a tube 1330 (i.e., the end of tube 1330 not coupled to a drain extension (not shown) and configured to exit the introitus). A first flexible stylet, or guide wire, 1340A and a second flexible stylet, or guide wire, 1340B are coupled to an exterior surface of tube 1330 via a plurality (in this case, five) attachment mechanisms 1350 through which first and / or second stylets 1340A and / or 1340B may articulate up and down (as oriented in FIG. 13A) to bend, or curve, a distal end of tube 1330 as shown in FIG. 13B, which may assist with guiding the distal end of tube 1330 through the cervix and into the vagina. In particular, the curvature of the distal end of tube 1330 is caused by pulling first stylet 1340A downward (as oriented in the figure), or away from the distal end of tube 1330. In some embodiments, uterine drain 1330 may have more than two stylets 1340. For example, tube 1330 may be coupled to three, four, or six stylets to enable bending or curving of tube 1330 in different directions along multiple planes.

[0098] FIGs. 14A and 14B are schematic diagrams of a portion of a uterine drain system 1400, and in particular a portion of uterine drain system showing a distal end of a tube 1430 (i.e., the end of tube 1430 not coupled to a drain extension (not shown) and configured to exit the introitus). Tube 1430 includes a plurality of segments 1440 that enable articulation and / or curving of tube 1440 but are sized, arranged, and configured to prevent folding or kinking of tube 1430 because they prevent the folding over of tube 1430 as it travels through the cervical and vaginal canals of a patient.

[0099] In some embodiments, a uterine drain and / or stylet positioned within a uterine drain may have include a pre-set (e.g., at the factory) curved portion configured to, for example, match patient anatomy and / or ease feeding the uterine drain through patient anatomy, particularly through the transition from the external cervical os to the vagina, which roughly orthogonal to the cervical canal. FIG. 15provides a top view of an exemplary uterine drain 1500 that includes a tube 1530 with a pre-set curvature configured and shaped to assist with insertion of uterine drain 1500 and / or navigating the transition between the cervical canal and vagina as uterine drain 1500 is fed through the hysterotomy to be properly positioned within patient anatomy. Additionally, or alternatively, curvature of a uterine drain may be achieved via placement of a curved stylet like curved stylet 1600 therein as shown in FIG. 16. A curvature of curved tube 1530 and / or curved stylet 1600 may be within a range of 10-120 degrees and, at times, may approximate 75-105 degrees or 90 degrees.[000100] In some embodiments, curved tube 1530 and / or curved stylet 1600 may achieve and / or maintain their curvature via a shape memory material (e.g., shapememory metal and / or shape memory plastic) that, on some occasions, may be thermally responsive. For example, in some embodiments, a curvature of curved tube 1530 and / or curved stylet 1600 may be pre-set at the factory and / or may be set and / or adjusted by a clinician and / or technician prior to insertion into a patient and may be configured to return to a straight tube and / or stylet upon exposure to body heat. For example, when curved tube 1530 and / or curved stylet 1600 is initially inserted into the uterus, the curvature may be at its greatest angle (e.g., 90 or 75 degrees) and upon warming caused by exposure to patient tissue and absorption of heat from the patient, the curvature may relax and / or straighten (e.g., 40-0 degrees) as curved tube 1530 and / or a tube with curved stylet 1600 inserted therein progresses through the vaginal canal. The thermally responsive curved tube 1530 and / or curved stylet 1600 may be configured so that it is most curved as the distal end (i.e., the end that will exit the introitus when the uterine drain is in position) navigates the anatomical curvature present where the cervix meets the vagina proximate to the external cervical os and then begins to straighten via absorption of body heat as curved tube 1530 and / or a tube with curved stylet 1600 positioned therein is navigated through the vagina, which may reduce a risk of trauma to vaginal tissues that may have otherwise been caused if curved tube 1530 and / or a tube with curved stylet 1600 maintained its initial degree of curvature (which was helpful when exiting the cervix and entering the vagina).[000101] Additionally, or alternatively, a uterine drain and / or stylet positioned within a uterine drain may be moldable (e.g., on-site) into non-linear (i.e., curved) shape. Moldability of a uterine drain and / or stylet may be achieved by, for example, use of atube 130 and / or stylet configured to bend in one or more directions and hold its shape via, for example, a shape-memory plastic and / or a shape-memory metal that may be resident within the stylet and / or a sidewall of tube 130.[000102] In another embodiment, a stylet may be configured so that it allows for movement in in one or more directions but not in others. For example, a stylet may be shaped so that it allows movement forward and back but not side to side. Stylet 1700, a cross-section view of which is shown in FIG. 17, has an ovoid cross- sectional shape that allows movement in two dimensions corresponding to the thinner (in this case, top and bottom as oriented in FIG. 17) sides of stylet 1700 but not side to side.[000103] In some embodiments, one or more components of a uterine drain like the uterine drains disclosed herein and / or a portion thereof (e.g., a tube) may be configured to bend and / or be malleable and, on some occasions, may be configured to maintain a shape into which they are bent during insertion and / or placement of the uterine drain. In some embodiments, the tube may be bent by a clinician responsively to an examination (e.g., digital or ultrasound) of the patient so that navigation of the tube through the patient’s cervix and / or vagina may be easier than if the tube was not bent. On some occasions, flexibility of a tube may be achieved by a bendable wire and / or stiffening member within a sidewall of the tube.[000104] FIG. 18A, which is a schematic diagram of a cross-section view of a tube 1830 with two stiffening and / or malleable members 1810 present in a sidewall thereof. Stiffening and / or malleable members 1810 may be configured to, for example, increase a stiffness of tube 1830A and / or prevent the kinking, twisting, or undesired bending of tube 1830A. Additionally, or alternatively, stiffening and / or malleable members 1810 may be configured to, for example, bend and maintain a bent shape as shown in, for example, FIG. 18D. FIG. 18B is a schematic diagram of a cross-section view of a tube 1830B with four stiffening and / or malleable members 1810 present in a sidewall thereof and FIG. 18C is a schematic diagram of a crosssection view of a tube 1830C with a single stiffening and / or malleable member 1810 present in a sidewall thereof. FIG. 18D is a schematic diagram of a side view of the uterine drain system 1801 including the tube 1830A, 1830B, or 1830C with a bent curvature 1845 facilitated by the stiffening and / or malleable member(s) 1810 present in a sidewall thereof.[000105] FIG. 19 is a schematic diagram of a top view of a portion of a tube 1930 with a spiraling wire 1935 present in a sidewall thereof. Spiraling wire 1935 may be configured to add flexibility to tube 1930 while preventing kinking, bending, or compression of tube 1930. Wire 1935 may spiral around tube with a consistent placement between adjacent segments and / or with varying (e.g., more or less dense) adjacent segments. For example, a spiral for wire 1935 may be denser proximate to tip 140 and less dense proximate to drain extension 110. In some embodiments, wire 1935 may have characteristics similar to stiffening and / or malleable member 1810 and / or may be used like stiffening and / or malleable member 1810.[000106] In some embodiments, a uterine drain like the uterine drains disclosed herein may be inserted using a curved inserter. In these embodiments, the surgeon or doctor may insert a curved inserter into a hysterotomy, into a patient’s internal cervical os, through the cervical canal, and into the vagina. When arranged in this fashion, the inserter may create a path and / or provide a guide for a tip and tube of a uterine drain (e.g., tip 140 and tube 130) to be pushed through the cervix, through and out of the vagina.[000107] Additionally, or alternatively, some embodiments of the uterine drains disclosed herein may include a stiffening member (e.g., wire or plastic) within a sidewall thereof. For example, any of the tubes and / or drain extensions disclosed herein may have a wire embedded in a sidewall thereof. The wire may be configured as concentric rings that encircle a diameter of the sidewall and / or as a spiral that loops around the sidewall of the tube and / or drainage extension along its length or a portion of its length. In some embodiments, a density and / or diameter of the wire may vary along a length of the tube and / or drain extension. The stiffening member may be configured to, for example, prevent kinking or folding of tube and / or drain extension while not inhibiting the respective tube’s and / or drain extension’s ability to bend or curve as needed in situ and / or while being placed in situ.[000108] In some embodiments, a doctor or surgeon may rotate or twist one of the uterine drains disclosed herein in a clockwise and / or counter-clockwise direction while advancing it through patient anatomy to facilitate navigation of the device through patient anatomy and assist with correct placement of the device.[000109] Additionally, or alternatively, some embodiments of the uterine drains disclosed herein may include an external helical, or spiral, threads extending alongall and / or a portion of the tube and / or tip. These threads may assist with twisting the tip and / or tube through patient anatomy during placement of the device.[000110] FIG. 20A provides a diagram of a top view of an exemplary uterine drain 2000 with an elongated tube 2030 that terminates in a closed end without a separate and / or removable endcap or tip 2015. FIG. 20B provides a diagram of a top view of exemplary uterine drain 2000 with an elongated stylet 2010 positioned within a central lumen 2035 thereof.[000111] During use, tube 2030 may extend through a patient’s cervix and vagina and exit the introitus and be cut to a preferred length (as shown in FIG. 20C) that may, for example, enable easy and / or comfortable coupling to a source of suction that, in some instances, may be responsive to patient anatomy and / or positioning of a source of negative pressure (e.g., wall suction). When elongated stylet 2010 is used, it may be removed from the central lumen of uterine drain 2000 following proper placement of uterine drain 2000 in patient anatomy, before cutting tube 2030 to a preferred length, and / or prior to closing a surgical opening to the uterus. Elongated stylet 2010 may be removed from the central lumen of uterine drain 2000 via manipulation thereof via a surgical opening to the uterus and extracting it from the uterus via the surgical opening.[000112] In some embodiments, a tip and / or endcap of uterine drain may be deformable and / or flexible so that it may be pulled through a central lumen of a tube (e.g., tube 130) and exit an opening positioned at a terminating end of a drainage extension (e.g., drainage extension 130). For example, FIG. 21 A provides a crosssection view of uterine drain 110 with a stylet 2150 positioned within central lumen 135. Stylet 2150 is coupled to a deformable endcap 2140 that is configured to provide a sealed end to tube 130 as it is pushed through the cervix and vagina of a patient and is further configured to deform so that it me be pulled into central lumen 135 (see FIG. 21 B) when stylet 2150 is extracted from central lumen 135 via an opening in the uterus.[000113] FIG. 22A provides a side view of an exemplary uterine drain guide 2200 that includes an approximately straight portion 2210 and a curved portion 2220. Guide 2200 may be configured to assist with the placement of a uterine drain like the uterine drains disclosed herein as discussed with regard to process 2300 of FIG. 23. [000114] FIG. 22A also provides a vertical cross-sectioning line 22B or 22C-22B or 22C and the cross-sections taken along this line are provided by FIGs. 22B and 22C,wherein the cross-section of FIG. 22B illustrates an embodiment wherein guide 2200 has an ovoid cross section and the cross-section of FIG. 22C illustrates an embodiment wherein guide 2200 has a semi-circular cross section with a channel 2230 therein. Channel 2230 may be sized and / or configured to accept positioning of a portion of a uterine drain like the uterine drains disclosed herein therein. Once in position within channel 2230, the uterine drain and / or a portion thereof may be advanced along channel 2230 through the patient’s cervix and into the vagina. [000115] FIG. 23 provides a flowchart of a method for positioning a uterine drain that may, or may not, include a stylet within a uterus of a patient via a surgical opening in the uterus as may happen during a cesarean section. Once in position, the uterine drain may, for example, drain fluid (e.g., blood, urine, etc.) and / or blood clots from the uterus and / or contract a size, or volume, of the uterus by, for example, application of suction tamponade thereto.[000116] Initially, in step 2305, a guide like guide 2200 and / or a bougie may be inserted into a surgical opening in the uterus and advanced through the cervix and into the vaginal canal of a patient. Execution of step 2305 may include advancing a curved portion (curved portion 2220) into the internal cervical os, through the cervical canal, out the external cervical os, and into the vagina. The shape of curved portion may be configured and / or designed to make it easier to navigate an intersection between the cervix and vagina. In particular, the shape of the curved portion of the guide may be configured to navigate the retrograde angle of the cervix so that an angle of approach to the vagina may change to better align with the orientation of the vagina. This will make it easier for the tube of the uterine drain to navigate this intersection and proceed through the vagina and out the introitus.[000117] Once the guide is position, a flexible tube (e.g., tube 130) of a uterine drain may be advanced along the guide so that it navigates the cervix, enters the vagina, and optionally exits the introitus (step 2310). The guide may then be removed from the uterus, cervix, and / or vagina via the surgical opening in the uterus (step 2315) and the uterine drain may be fully seated within the patient’s anatomy (step 2320). At times, execution of step 2320 may include ensuring the drain extension (e.g., drain extension 110) extends into the uterus, ensuring an alignment mechanism (e.g., alignment mechanism 120) is seated proximate to the internal cervical os, pulling a portion of the tube (e.g., tube 130) out of the introitus, and / ortaping a portion of the tube extending from the introitus to the patient’s leg. In some embodiments (e.g., when uterine drain 300, 400, 2001 , 2100), a stylet and / or tip of the uterine drain may be extracted from the uterine drain via the surgical opening (step 2325) prior to surgically closing the uterus (step 2330). Alternatively, in other embodiments (e.g., when uterine drain 200, 500, 600, 1900), the uterus may be surgically closed (step 2330) and a stylet and / or tip of the uterine drain may be extracted from the uterine drain via the introitus (step 2325).[000118] Optionally, in step 2335, an end of the tube (e.g., tube 130) of the uterine drain extending from the patient’s the introitus may be coupled to a source of suction, such as a vacuum pump and / or a suction reservoir device. When uterine drain 2000 is being used to execute process 2300, execution of step 2335 may include removing tip 2015 as shown in FIG. 20C prior to coupling the tube to the source of suction. The amount of suction applied to the uterine drain may be within a range of 50-150mmHg. Additionally, or alternatively, in step 2340, the end of the uterine drain exposed by removal of the tip may be coupled to a collection device (e.g., gauze, absorbent pad, bag, and / or graduated cylinder) so that, for example, a quantity of fluid extracted from the hollow organ and / or tissue may be measured and / or observed to, for example, determine a volume of fluid extracted from the hollow organ and / or tissue and / or whether or not blood clots are present in the fluid / material evacuated from the hollow organ and / or tissue, and, if so, a volume and / or size of the blood clots collected in the fluid collection device. This information may be used by a clinician to determine, for example, whether a hemorrhage has developed and / or is present, a severity of potential blood loss for the patient, and / or whether or not bleeding has slowed to a degree that enables safe extraction of the uterine drain from the hollow organ and / or tissue.[000119] In step 2345, the uterine drain may be extracted from the hollow organ and / or tissue by, for example, pulling on a portion of the uterine drain positioned outside the uterus until the entire uterine drain is removed from the patient’s body. [000120] FIGs. 24A-24D provide various views of a stylet with differential stiffness 2400 (also referred to as a “differential stiffness stylet 2400” herein) along its length. In particular, FIG. 24A provides a side view of stylet 2400, which includes a relatively stiff, or rigid, portion 2410 and a flexible portion 2420 positioned between rigid portion 2410 and an optional tip 2430. Flexible portion 2420 may be configured to bend, or flex, in one or more directions while rigid portion 2410 remains relativelystraight as shown in the side view of FIG. 24B, wherein flexible portion 2420 has bent to a 90degree angle. In some embodiments, flexible portion 2420 may be configured to bend with 360, 180, or 90degrees of freedom over an angle ranging between, for example, 20-90degrees.[000121] Differential stiffness stylet 2400 may be positioned within, and extend partially, or wholly, along a length of a uterine drain like the uterine drains disclosed herein. For example, FIG. 24C provides a top view of an assembly 2401 of differential stiffness stylet 2400 positioned within a lumen of uterine drain 100. In this example, differential stiffness stylet 2400 extends along the length of uterine drain 100 from tip 2430 to a terminating end of drainage extension 110. FIG. 24D provides a detailed view of FIG. 24C when flexible portion 2420 is bent at an angle, wherein the flexibility of flexible portion 2420 guides the bending of an overlying portion of tube 130 without allowing tube 130 to kink or otherwise bend in an undesirable manner.[000122] FIG. 25 provides a flowchart of a method for positioning a uterine drain that includes a stylet with differential stiffness (e.g., stylet 2400) within a uterus of a patient via a surgical opening in the uterus as may happen during a cesarean section. Once in position, the uterine drain may, for example, drain fluid (e.g., blood, urine, etc.) and / or blood clots from the uterus and / or contract a size, or volume, of the uterus by, for example, application of suction tamponade thereto.[000123] Initially, in step 2505, a tube of a uterine drain with a stylet of differential stiffness positioned therein (e.g., assembly 2401) may be inserted into a uterus of a patient via a surgical opening in the uterus. A flexible portion of the tube (e.g., a portion of the tube housing flexible portion 2420) may be advanced (e.g., pushed) through the patient’s cervix and around an intersection between the patient’s uterus and vagina (step 2510). Then, a less flexible portion of the tube (e.g., a portion of the tube housing more rigid portion 2410) may be advanced partially through the cervix and used to adjust an orientation of the cervix relative to the vagina, thereby allowing the remainder of the tube to navigate the intersection of the cervix and vagina (step 2515). In some cases, execution of step 2515 may include using the less flexible portion of the tube as a lever to tilt, or manipulate, the cervix so that the remainder of the tube may be pushed through the external cervical os and into the vagina so that it may proceed toward the introitus. Following step 2515, steps 2320- 2345 may be performed.[000124] During use, in some instances, tube 130 may fold over itself during the insertion process while traveling through the vagina. When this happens, a clinician may manually enter the vagina to pull a distal end of the tube out so that it may be coupled to suction. However, it is often difficult for the clinician to identify the distal end of the tube and, as such, they may pull the wrong end of the tube out of the vagina and unintentionally dislodge the uterine drain from the uterus. To avoid this outcome, tactile features may be added to the distal end of the tube. These tactile features may be pf any shape (e.g., circle, triangle, ridge, bump, ring, etc.) raised from (e.g., sit proud) of the tube and / or be indented into the tube and may be configured to mark or orient the clinician to the distal end of the tube by touch so that he / she pulls the correct (i.e., distal) end of the tube out of the vagina without dislodging the uterine drain from the uterus. The tactile features may be provided on, for example, one or two sides (e.g., top and bottom) of a uterine drain’s tube and / or may be arranged circumferentially around the tube. Any of the uterine drains herein may include one or more tactile features thereon.[000125] FIGs. 26A and 26B provide a few examples of uterine drains that may include tactile features, wherein FIG. 26A provides a schematic diagram of a uterine drain 2601 with an array 2615 including a plurality (in this case, five) tactile features 2610 on and / or in a tube 2620. Tactile features 2610 may be configured as arrows that point toward a distal end of uterine drain 2601 and increase in size from a proximal side of array 2615 to a distal side of array 2615 to further tactilely indicate to the clinician which end of tube 2601 is the distal end. The example of FIG. 26B provides a single tactile feature 2650 that tapers to increase in width along the length of a tube 2630 so that it is widest at a distal end of tube 2650 and narrowest toward a proximal side of tube 2630.[000126] Additionally, or alternatively, one or more of the uterine drains disclosed herein may include one or more drain extension length markers that a clinician may use a markers to trim a drain extension (e.g., drain extension 110) to a preferred length. In some cases, the length markers may be positioned every 0.1 -2cm along the length of the drain extension. The drain extension length markers may be visual (e.g., printed on) and / or tactile (e.g., raised rings or ridges). The uterine drains of FIGs. 26A and 26B provide a set of exemplary drain extension length markers 2625 that extend the length of drain extension 110.[000127] FIGs. 27A and 27B provide an exploded and a top view, respectively, of a uterine drain 2700 configured for insertion via a surgical opening in the uterus (e.g., hysterotomy). Uterine drain 2700 includes drain extension 110, tube 130, a stylet 2744, and a tip 2740 that includes a recessed portion 2742. Stylet 2744 may be sized and configured to fit within central lumen 135 of tube 130 and extend along its length from tip 2740 to a point within tube 130 and, in some embodiments, drain extension 110. In some embodiments, stylet 2744 may be configured to extend through an entire length of uterine drain 2700 (e.g., through tube 130 and drain extension 110). When stylet 2744 is configured to extend into drain extension 110, it may also be configured to remove clots that may have accumulated on drain extension 110 and / or one or more holes thereof when it is extracted from central lumen 135 prior to, for example, coupling open end of tube 130 to suction and / or a fluid collection vessel. Removal of the clots from the hole(s) of drain extension 110 may be achieved via, for example, movement (e.g., extraction, insertion and / or rotation) of stylet 2744 within drain extension 110 in a manner that dislodges clots from the holes and / or breaks them into smaller pieces that may be pulled into one or more of the holes for extraction from the uterus via central lumen 135.[000128] FIGs. 28A and 28B provide an exploded and a top view, respectively, of a uterine drain 2800 configured for vaginal and / or hysterotomy insertion. Uterine drain 2800 includes all the features of uterine drain 2700 along with an endcap 2810 positioned on an end of drain extension 110 not coupled to tube 130. Endcap 2810 may be configured to provide shape and / or form factor that facilitate insertion into the vagina, through the cervix, and into the uterus so that drain extension 110 may be positioned within the uterus while tube 130 extends through the vaginal of a patient so that, for example, stylet 2744 may be removed from tube via pulling, or otherwise extracting tip 2740, recessed portion 2742, and stylet 2744 from central lumen 130 of tube 130.[000129] FIGs. 29A and 29B provide an exploded and a top view, respectively, of a uterine drain 2900 configured for insertion via a surgical opening in the uterus (e.g., hysterotomy). Uterine drain 2900 includes drain extension 110, tube 130, a tube cap 2910, a stylet 2744, and a tip 2940 that includes a recessed portion 2942. Unlike with uterine drains 2700 and 2800, recessed portion 2942 may be sized and / or configured to fit within a lumen of drain extension 110 (as opposed to central lumen 135) so that stylet 2944 may be held in place within the lumen of drain extension 110and central lumen 135 until tip 2940 is pulled away from drain extension 110, thereby removing stylet 2944, recessed portion 2942, and tip 2940 from uterine drain 2900. In some embodiments, an end of stylet 2744 (i.e., the end not attached to recessed portion 2942 and tip 2940) may be configured to removably engage with tube cap 2910 to, for example, facilitate pushing tube cap 2910 and a portion of tube 130 through the cervix and vagina during placement via a hysterotomy. In these embodiments, tube cap 2910 and / or stylet 2744 may include one or more engagement features (e.g., ribs, bumps) configured to cooperate with one another to removably hold stylet 2744 within tube cap 2910. For example, FIG. 29C provides a cross-section view of tube cap 2910 that shows the sidewall of tube cap 2910 with an opening 2915 that has removably accepted of a portion of stylet 2744 therein. [000130] FIGs. 30A-30F provide diagrams showing a process for inserting, using, and removing uterine drain 2900 from a patient’s uterus via a midsagittal crosssection view of a portion of the patient’s anatomy. In particular, FIG. 30A shows the patient’s vagina 2040, cervix 2020, and uterus 3010 with a pool of blood collecting in a lower uterine segment thereof. Uterus 3010 is open via a surgical opening 3030 as may occur during uterine and / or pelvic surgery (e.g., .a cesarian section). To insert uterine drain 2900 into uterus 3010, tube cap 2910 is inserted into surgical opening 3030 and advanced into the uterus as shown in FIG. 30B until a junction between tube 130 and drain extension 110 is proximate to the internal cervical os as shown in FIG. 30C. Then, stylet 2944 is extracted from uterine drain 2900, or more particularly, from central lumen 135 and a lumen of drain extension 110, via pulling on tip 2740 so that recessed portion 2742 is extracted from the lumen of drain extension 110 as shown in FIG. 30D. Navigation of uterine drain 2900 through uterus 3010, cervix 3020, and / or vagina 3040 may be facilitated by stylet 2944 and / or tube cap 2910. FIG. 30D also shows that when drain extension 110 is seated within uterus 3010, tube 130 extends through cervix 3020 and vagina 3040 so that tube cap 2910, and a portion of tube 130 extends from the patient’s introitus and exits the body. Next, in FIG. 30E, tube cap 2910 and tube 130 may be cut, thereby opening tube 130 so that it may be coupled to a source of suction and / or a collection vessel fluid and material from uterus 3010 (e.g., the pool of blood therein) may be evacuated from uterus 3010 via holes in drain extension 110, the lumen of drain extension 110, and central lumen 135. When use of uterine drain 2900 is complete, itmay be pulled from uterus 3010, cervix 3020, and vagina 3040 via the portion of tube 130 extending from the introitus as shown in FIG. 30F.

Claims

CLAIMS1 . A uterine drain comprising: a tube comprising a first end, a second end, and a central lumen the tube being configured to reside within a patient’s cervix and extend through and out of the patient’s vagina during use; a drain extension configured to reside within the patient’s uterus during use, the drain extension comprising a first end, a second end, a plurality of drainage holes, and a drain extension lumen, the first end of the drain extension being in communication with the first end of the tube so that the drain extension lumen is in communication with the central lumen so that fluid entering one of the plurality of drainage holes enters the drain extension lumen for communication to the central lumen; a tip configured to be removably attached to, and cover, the second end of the drain extension, the tip being attached to a stylet; and the stylet resident within the drain extension and a portion of the central lumen, the stylet being configured to be removed from the drain extension and the portion of the central lumen via extraction of the tip from the second end of the drain extension.

2. The uterine drain of claim 1 , wherein the tip is removable from the second end of the drain extension via a surgical opening in the patient’s uterus.

3. The uterine drain of claim 1 or 2, wherein the tip comprises one or more features that enable secure manual grasping of the tip so that it may be extracted from the drain extension upon placement of the uterine drain within the patient’s uterus.

4. The uterine drain of any of claims 1-3, wherein the stylet extends through an entirety of the central lumen.

5. The uterine drain of any of claims 1-4, wherein drain extension is an extension of the tube.

6. The uterine drain of any of claims 1-4, wherein drain extension is separate component permanently attached to the first end of the tube.

7. The uterine drain of any of claims 1-6, further comprising: a tube cap extending attached to the second end of the tube, the tube cap being sized, positioned, and configured to allow for insertion into the patient’s vagina, through the patient’s cervix, and into the patient’s uterus.

8. The uterine drain of claim 7, wherein the tube cap is removable from the second end of the tube.

9. The uterine drain of claim 7, wherein the tube cap is removed from the second end of the tube via cutting the second end of the tube.

10. A method of using the uterine drain of any of claim 1-9 to evacuate fluid from a patient’s uterus.11 . A method of evacuating fluid from a patient’s uterus comprising: placing the uterine drain of any of claims 1-9 in the patient’s body so that the drain extension is positioned within the patient’s uterus and a portion of the tube extends from the patient’s introitus; and removing the stylet from the drain extension via a surgical opening in the patient’s uterus.

12. The method of claim 11, further comprising: coupling a source of suction or a collection vessel to an open end of the portion of the tube that extends from the patient’s introitus so that fluid that enters one or more of the plurality of drainage holes may be evacuated from the patient’s uterus via communication between the drain extension lumen and the central lumen.

13. The method of claim 11, further comprising: coupling a source of suction to an open end of the portion of the tube that extends from the patient’s introitus so that fluid that enters one or more of the plurality of drainage holes may be evacuated from the patient’s uterus via communication between the drain extension lumen and the central lumen; and applying an amount of suction sufficient to the central lumen sufficient to apply suction tamponade to the patient’s uterus.

14. A method of evacuating fluid from a patient’s uterus comprising: placing the uterine drain of claim 7 or 9 in the patient’s body so that the drain extension is positioned within the patient’s uterus and a portion of the tube extends from the patient’s introitus; removing the stylet from the drain extension via a surgical opening in the patient’s uterus; removing the tube cap from the second end of the tube, thereby creating an open second end of the tube; andcoupling a source of suction or a collection vessel to the open second end of the tube so that fluid that enters one or more of the plurality of drainage holes may be evacuated from the patient’s uterus via communication between the drain extension lumen and the central lumen.

15. A method of preventing post-partum hemorrhage following child delivery via caesarian section for a patient, the method comprising: placing the uterine drain of any of claims 1-9 in the patient’s body so that the drain extension is positioned within the patient’s uterus and a portion of the tube extends from the patient’s introitus; removing the stylet from the drain extension via a surgical opening in the patient’s uterus; coupling a source of suction to an open end of the portion of the tube that extends from the patient’s introitus; and applying an amount of suction to the central lumen sufficient to apply suction tamponade to the patient’s uterus.

16. A uterine drain comprising: a tube with a first end, a second end, and a central lumen the tube being configured to reside within a patient’s cervix and extend through and out of the patient’s vagina during use; a drain extension in communication with the first end of the tube, the drain extension comprising a drain extension lumen in communication with the central lumen and a plurality of drainage holes configured to allow fluid to enter the drain extension lumen, the drain extension being configured to reside within the patient’s uterus during use; a tip configured to be removably attached to, and cover, the second end of the tube, the tip being attached to a stylet; and the stylet resident within the central lumen and a portion of the drain extension lumen, the stylet configured to be removed from the central lumen and the portion of the drain extension lumen via extraction of the tip from the second end of the tube.

17. The uterine drain of claim 16, further comprising: an endcap extending from an end of the drain extension, the endcap being sized, positioned, and configured to allow for insertion into the patient’s vagina, through the patient’s cervix, and into the patient’s uterus.

18. The uterine drain of claim 16 or 17, wherein the stylet extends through an entirety of the drain extension.

19. The uterine drain of any of claims 16-18, further comprising: a tube cap extending from and / or attached to the second end of the tube, the tube cap may be sized, positioned, and configured to allow for insertion into the patient’s vagina, through the patient’s cervix, and into the patient’s uterus.

20. A method of using the uterine drain of any of claim 16-18 to evacuate fluid from the patient’s uterus.

21. A method of evacuating fluid from a patient’s uterus comprising: placing the uterine drain of any of claims 16-18 in the patient’s body so that the drain extension is positioned within the patient’s uterus and a portion of the tube extends from the patient’s introitus; and removing the stylet from the drain extension via pulling on the tip, thereby creating an open second end of the tube; and coupling a source of suction to the open second end; and applying an amount of suction to the central lumen sufficient to apply suction tamponade to the patient’s uterus.

22. A method of preventing post-partum hemorrhage following child delivery via caesarian section for a patient, the method comprising: placing the uterine drain of any of claims 16-18 in the patient’s body so that the drain extension is positioned within the patient’s uterus and a portion of the tube extends from the patient’s introitus; and removing the stylet from the drain extension via pulling on the tip, thereby creating an open second end of the tube; and coupling a source of suction to an open end of the portion of the tube that extends from the patient’s introitus; and applying an amount of suction to the central lumen sufficient to apply suction tamponade to the patient’s uterus.

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