WO2025054617A1

WO2025054617A1 - Medical drain with shaped insertion tip

Info

Publication number: WO2025054617A1
Application number: PCT/US2024/045867
Authority: WO
Inventors: E. Skott Greenhalgh; Robert Kiefer; Nathan GREENHALGH; Benjamin HAMAR
Original assignee: Koko Medical Inc
Current assignee: Koko Medical Inc
Priority date: 2023-09-07
Filing date: 2024-09-09
Publication date: 2025-03-13
Anticipated expiration: 2026-03-07

Abstract

Medical drains for removing fluid, gas and/or solid materials from a body region, such as a body cavity. The apparatuses are well suited for the treatment of postpartum hemorrhaging of a postpartum uterus. The apparatuses include an insertion tip sized and shaped for atraumatic insertion into a non-dilated or minimally dilated cervix, such as in the case of caesarean sections. The apparatuses include a mesh tube, which may be extended into the body region to facilitate removal of fluid and other bodily material from the body region when suction is applied. The mesh tube may also distribute the suction to reduce hemorrhaging.

Description

MEDICAL DRAIN WITH SHAPED INSERTION TIP

CLAIM OF PRIORITY

[0001] This patent application claims priority to U.S. provisional patent application no. 63/581,261, titled “MEDICAL DRAIN WITH SHAPED INSERTION TIP,” and filed on September 7, 2023, herein incorporated by reference in its entirety.

INCORPORATION BY REFERENCE

[0002] All publications and patent applications mentioned in this specification are herein incorporated by reference in their entirety to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference.

BACKGROUND

[0003] Postpartum hemorrhage, which is excessive uterine blood loss after birth, is the leading cause of maternal death in the world. The most common cause of postpartum hemorrhage is poor contraction of the uterus following childbirth. Normally after childbirth, the uterine muscles contract to cut off the blood flow to effectively pinch the arterial vessels that run through the tissue. Postpartum uterine bleeding can occur when the uterine muscles are unable to achieve adequate contraction after delivery to cut off the blood flow that formerly circulated in the utero-placental space, thereby leading to a steady loss of blood. The condition for this lack of contraction is referred to as uterine atony (lack of tone). The inability to control postpartum bleeding may require a woman to receive multiple blood transfusions, and in severe cases, a full hysterectomy.

[0004] Postpartum hemorrhage may occur regardless of whether the delivery is a vaginal delivery or a caesarean section. Excessive hemorrhage associated with caesarean section has been estimated to occur in more than 5% to 10% of caesarean sections. The excessive bleeding may be associated with injuries to pelvic arteries, uterine atony, or placental abnormality after caesarean section.

[0005] Current medical devices and surgical procedures for postpartum hemorrhage have proven inadequate in reducing the amount of blood lost, and/or are extremely invasive (e.g., laparotomy or hysterectomy). Accordingly, there is a need for effective and safe treatments for controlling postpartum bleeding. SUMMARY OF THE DISCLOSURE

[0006] Described herein are apparatuses (e.g., devices and systems) and methods that are effective in removing fluid, gas and/or solid materials from a body region, such as a body cavity. The apparatuses are well suited for the treatment of a postpartum uterus for prevention of postpartum hemorrhage, in particular after a caesarean section. The apparatuses may be sized and shaped for insertion into a non-dilated or minimally dilated cervix, such as in the case of caesarean sections. The apparatuses may include a shaped insertion tip for atraumatic inserting into a body orifice (e.g., external orifice of the cervix), particularly a cervix that is dilated 3 cm or less (as may be the case following a caesarean procedure), and a tubular mesh tube that is configured to be extended into the body region. Suction (negative pressure) may be applied to draw fluid (e.g., blood) and other bodily material into an elongate member (e.g., tube) via the mesh tube. The suction may also provide an inward pressure within the body cavity to cause walls of the body cavity to contract, thereby reducing hemorrhaging.

[0007] Described herein are apparatuses (e.g., devices, systems, etc., including in particular medical drain devices). For example, described herein are medical drain devices that may include: a first elongate member having a suction lumen; a second elongate member that is movably disposed in the suction lumen of the first elongate member; a tapered insertion tip at a distal end of the first elongate member, the tapered insertion tip having a distally tapered outer surface and a suction opening therethrough; and a mesh tube that is coupled to the second elongate member, wherein the mesh tube is configured to transition between an extended configuration, in which the mesh tube is extended distally past the suction opening of the tapered insertion tip, and a retracted configuration in which the mesh tube is retracted proximally into the suction lumen of the first elongate member by moving the second elongate member relative to the first elongate member, further wherein the mesh tube in the extended configuration is configured to provide a plurality of flow paths for fluid to flow to the suction opening when suction is applied from the suction opening.

[0008] The tubular mesh (e.g., mesh tube) may be formed of a knitted, braided or woven material. In general, the mesh tube may be formed of a plurality of lengths of filaments that are able to slide over each other, which may enhance conformation of the mesh tube to the patient anatomy and provide a multiple fluid paths to allow draining, while preventing clogging of the (suction opening). These apparatuses may generally have a single suction opening having a relatively large diameter (e.g., the inner diameter of the first elongate member). The suction opening may be at the distal end opening of the first elongate member. The mesh tube may therefore be safely used to prevent clogging and to provide micro- channels in fluid communication with the suction opening without the need for shielding. The length of filament may be part of a single strand of filament (e.g., when the mesh tube is formed by a knitted filament) or it may be formed by a plurality of strands (e.g., when the mesh tube is formed by a woven or braided filament). The filament may be formed of a synthetic (e.g. polymeric) material or a natural material that is biocompatible. The filament may be a monofiber (e.g., a single fiber) of a bundle of fibers.

[0009] The mesh tube may be fixed to just the second, e.g., inner, elongate member that is movable (e.g., slidable) within the first, outer elongate member. For example, the mesh tube may be coupled to the second elongate member at a proximal end region and a distal end region. Thus, the distal end portion of the second elongate member may extend distally out of the suction lumen with the distal end portion of the mesh tube. In some examples at least a portion of the mesh tube may remain within the suction lumen, providing the plurality of microchannels following the plurality of filament lengths into the suction lumen (e.g., in a continuous path), which may enhance the ability to remove fluid while preventing clogging. [0010] In any of these apparatuses the mesh tube may be held against the inner diameter of the suction opening when extended distally out of the suction opening. In some cases the mesh tube may be configured to have an outer diameter at rest (e.g., unconstrained within the suction lumen) that is equal to or larger than the diameter of the suction opening.

[0011] Alternatively the mesh tube may be fixed to both the second elongate member and the first elongate member, so that the mesh tube inverts over itself as it is driven distally out of the suction opening. For example, the mesh tube may be configured to transition between the extended configuration and the retracted configuration by rolling and inverting over itself. The mesh tube may be coupled to the second elongate member at a distal end region of the second elongate member and may be coupled to the first elongate member, e.g., at a distal end region. The mesh tube may be coupled to the first elongate member at a distal end region of the first elongate member and may be coupled within the suction lumen of the first elongate member.

[0012] In any of these apparatuses and methods, the suction opening may be at least partly covered by a deflectable distal region of the tapered insertion tip. The deflectable distal region may cover all or at least a part of the suction opening during insertion, to prevent harm to the tissue during insertion. This deflectable distal region may be moved away from the tip when extending the mesh tube out of the device. In some cases the deflectable distal region is a lid or cover that is tethered to the tapered insertion tip. In some cases the deflectable distal region is a plurality of flexible sections (e.g., petals) that can be pushed open to permit passage of the mesh tube. [0013] The suction opening may be distal-facing. The suction opening may be at the distal end of the device, or it may be on a side of the tapered insertion tip, e.g., as a lateral opening on the tapered outer surface of the tapered insertion tip. In some cases, e.g., where the suction opening is a lateral opening, the tapered insertion tip may be configured to deflect or guide the mesh tube out of the suction opening and into the cavity (e.g., uterus). For example, the tapered insertion tip may comprise a channel between the suction lumen and suction opening. The channel may not be parallel to a central axis through the insertion tip. In some cases the channel is configured to deflect the mesh tube as it exists the suction opening. [0014] In general, the tapered insertion tip may be configured to seal against the orifice of a cavity and/or through the orifice (e.g., the cervix and/or endocervical canal). For example, the tapered insertion tip may have a larger outer diameter than an outer diameter of the first elongate member. For example, the tapered insertion tip may be configured to seal to a cervix that is dilated less than 3 cm. The insertion tip may have a tapered outer surface that is configured for atraumatic entry into a cervix that is dilated less than 3 cm, in some cases by tapering to a diameter that is less than 3 cm. The device may be further configured so that the suction opening is configured to be distal to tapered region having a diameter of less than 3 cm.

[0015] In general, the tapered insertion tip may be radially tapered from a larger diameter at a proximal portion of the tapered insertion tip to a smaller diameter at a distal portion of the tapered insertion tip.

[0016] Also described herein are apparatuses in which the tubular mesh comprises a tubular core surrounded by a tubular sheath, wherein at least the tubular sheath comprises braided fibers. The tubular sheath and the tubular core may each comprise braided fibers, wherein the tubular sheath and the tubular core have one or more of the following differences: different fiber diameters, different braid densities, different pick counts, and different fiber shapes. In some cases the tubular sheath may have a smoother outer surface than the tubular core.

[0017] Also described herein are apparatuses in which the insertion tips is an adapter configured to be inserted over a potentially separate drain apparatus including the mesh tube. In some cases the tapered insertion tip may be coupled to a proximal cannula, wherein the insertion tip and the proximal cannula may be separable from first elongate member, wherein the proximal cannula is configured to fit over the first elongate member when the mesh tube is extended through the opening of the insertion tip. The proximal cannula may be configured to engage with the first elongate member. In some cases the proximal cannula may be configured to attach over first elongate member. [0018] In some cases the second elongate member may include a distal member, e.g., a cap, which may be configured as a sphere/hemi sphere, capsule, etc. (typically having a rounded, atraumatic surface or surfaces) that is coupled with the second elongate member distal to the tubular mesh. This distal cap may be configured to at least partially cover the suction opening when the tubular mesh is in the retracted configuration.

[0019] In any of these apparatuses the second elongate member is configured as a flexible member that has a relatively high column strength, to allow pushing of the mesh tube distally. In some cases the second elongate member is a rod. The rod may be solid or hollow. A hollow rod may be sealed closed at one or both ends.

[0020] Any of these apparatuses may include a proximal handle. The proximal handle may be coupled to the first elongate member. The proximal handle may have a suction port in fluid communication with the suction lumen. The proximal handle may be configured to allow manual operation of the apparatus by a user (e.g., medical professional, such as a surgeon, doctor, nurse, etc.). The proximal handle may include a second handle portion that is coupled to the second elongate member to allow movement of the second elongate member within he first elongate member to deploy/retract the mesh tube forming the drain. In any of these apparatuses the handle may include one or more seals (e.g., o-rings, etc.) that between the proximal handle and the outer surface of the second elongate member that are configured to maintain suction through the suction lumen as the second elongate member is moved laterally within the suction lumen.

[0021] In some examples a medical drain device may include: a first elongate member having a suction lumen; a second elongate member that is movably disposed in the suction lumen of the first elongate member; an insertion tip coupled to a distal end of the first elongate member, the insertion tip having a tapered outer surface configured for atraumatic entry into a cervix that is dilated less than 3 cm by tapering to a diameter that is less than 3 cm; a suction opening on the insertion tip that is in fluid communication with the suction lumen; and a mesh tube that is coupled to the second elongate member, wherein the mesh tube is configured to transition between an extended configuration, in which the mesh tube is extended distally past the opening of the insertion tip, and a retracted configuration in which the mesh tube is retracted proximally into the suction lumen of the first elongate member by moving the second elongate member relative to the first elongate member, further wherein the mesh tube in the extended configuration is configured to provide a plurality of flow paths for fluid to flow to the suction opening when suction is applied from the suction opening. [0022] A medical drain device may include: a first elongate member having a suction lumen; a second elongate member that is movably disposed in the suction lumen of the first elongate member; an insertion tip coupled to a distal end of the first elongate member, the insertion tip having a tapered outer surface configured for atraumatic entry into a cervix that is dilated less than 3 cm; a suction opening on the insertion tip that is in fluid communication with the suction lumen; and a mesh tube that is coupled to the second elongate member at a proximal end region and at a distal end region, wherein the mesh tube is configured to transition between an extended configuration, in which the mesh tube is extended distally past the opening of the insertion tip, and a retracted configuration in which the mesh tube is retracted proximally into the suction lumen of the first elongate member by moving the second elongate member relative to the first elongate member, further wherein the mesh tube in the extended configuration is configured to provide a plurality of flow paths for fluid to flow to the suction opening when suction is applied from the suction opening.

[0023] Also described herein are methods of using any of these apparatuses to drain a body cavity. Although the body cavity described herein is shown as a uterus (e.g., to prevent or limit hemorrhaging) these apparatuses may be used with any appropriate body cavity, including but not limited to natural body cavities (e.g., gastrointestinal cavities, lungs, etc.) or wound cavities.

[0024] For example, a method may include: inserting a tapered insertion tip at a distal end of a first elongate member of a medical drain device through an orifice of a cavity in a body, wherein the orifice has an open diameter that is less than a diameter of the tapered insertion tip; extending a mesh tube distally out of a suction opening on the tapered insertion tip and into the cavity by distally advancing a second elongate member to which the mesh tube is attached, wherein the second elongate member is movably disposed within a suction lumen of the first elongate member; and applying suction from the suction lumen through the suction opening so that fluid from the cavity passes through a plurality of flow paths formed by the mesh tube and into the suction lumen.

[0025] As described, extending the mesh tube distally out of the suction opening may comprise unrolling and inverting the mesh tube by advancing the second elongate member to which a first end of the mesh tube is coupled, while a second end of the mesh tube is coupled to the first elongate member. Alternatively or additionally, in some cases extending the mesh tube distally out of the suction opening comprises advancing the second elongate member distally out of the suction opening. For example, extending the mesh tube distally out of the suction opening may comprise advancing the second elongate member distally out of the suction opening, wherein a first end of the mesh tube is coupled to a distal region of the second elongate member and a second end of the mesh tube is coupled to a proximal region of the second elongate member. [0026] In any of these methods, inserting the tapered insertion tip comprises inserting the tapered insertion tip until the suction opening is within the cavity. In some cases extending the mesh tube distally out of the suction opening comprises deflecting a deflectable distal region of the tapered insertion tip so that the mesh tube can extend distally out of the suction opening. Deflecting the deflectable distal region may comprise deflecting a plurality of deflectable distal regions.

[0027] In some cases extending the mesh tube distally out of the suction opening comprises extending a distal cap proximal to the mesh tube distally out of the suction opening.

[0028] The tapered insertion tip may have a larger outer diameter than an outer diameter of the first elongate member. In some cases extending the mesh tube distally out of the suction opening comprises extending the mesh tube through a channel in the tapered insertion tip to guide the mesh tube along a path through the insertion tip that is not parallel to a long axis of the insertion tip. Any of these methods may include maintaining the application of suction to reduce hemorrhaging. Inserting the tapered insertion tip may comprise inserting the tapered insertion tip through a cervix that is dilated less than 3 cm and into a postpartum uterus.

[0029] Extending the mesh tube may comprise extending a tubular core surrounded by a tubular sheath, wherein at least the tubular sheath comprises braided fibers. The tubular sheath and the tubular core may each comprise braided fibers, wherein the tubular sheath and the tubular core have one or more of the following differences: different fiber diameters, different braid densities, different pick counts, and different fiber shapes. The tubular sheath may have a smoother outer surface than the tubular core.

[0030] Any of these methods may include removing a blood clot from the tubular mesh by pulling the tubular mesh at least partially proximally back into the suction lumen to remove the blood clot off of the tubular mesh, and extending the tubular mesh distally back into the body cavity.

[0031] For example, a method may include: inserting a tapered insertion tip at a distal end of a first elongate member of a medical drain device through an orifice of a cervix, wherein the cervix is dilated to less than 3 cm; extending a mesh tube distally out of a suction opening on the tapered insertion tip and into a postpartum uterus by distally advancing a second elongate member to which the mesh tube is attached, wherein the second elongate member is movably disposed within a suction lumen of the first elongate member; and applying suction from the suction lumen through the suction opening so that fluid from the uterus passes through a plurality of flow paths formed by the mesh tube and into the suction lumen.

[0032] In some examples, a medical drain includes: a first elongate member having a lumen; a second elongate member that is slidably disposed in the lumen of the first elongate member; an insertion tip coupled to a distal end of the first elongate member, the insertion tip having a rounded distal end and a tapered outer surface that are configured for atraumatic entry of a body orifice; and a mesh tube coupled to the first elongate member and the second elongate member, wherein the mesh tube is configured to transition between an extended configuration, in which most of the mesh tube is extended distally past an opening of the insertion tip, and a retracted configuration, in which most of the mesh tube is within the lumen of the first elongate member, wherein the mesh tube is configured to provide a plurality of flow paths for fluid to flow through when suction is applied through the first elongate member.

[0033] At least a portion of the insertion tip may have a larger outer diameter than an outer diameter of the first elongate member. The insertion tip may be sized and shaped to create a seal with a non-dilated or minimally dilated cervix. The insertion tip may taper from a larger diameter at a proximal portion of the insertion tip to a smaller diameter at a distal portion of the insertion tip. The mesh tube may include a tubular core surrounded by a tubular sheath, wherein at least the tubular sheath comprises braided fibers. The tubular sheath and the tubular core each comprise braided fibers, wherein the tubular sheath and the tubular core have one or more of the following differences: different fiber diameters, different braid densities, different pick counts, and different fiber shapes. The tubular sheath may have a smoother outer surface than the tubular core. The insertion tip may include a distal portion that is coupled to the second elongate member, and a proximal portion that is coupled to first elongate member, wherein the distal portion of the insertion tip is farther away from the proximal portion of the insertion tip when the mesh tube is in the extended configuration compared to when the mesh tube is in the retracted configuration. The insertion tip may include a distal portion that coupled to a proximal portion of the insertion tip at a hinge, wherein the distal portion is configured to deflect with respect to the proximal portion at the hinge when the mesh tube is extended out of the opening of the insertion tip. The opening may be located on a side of the insertion tip, wherein the insertion tip includes a channel that terminates at the opening, and wherein the channel defines a path that is non-parallel to a central axis of the insertion tip. The insertion tip may include multiple flexible sections that are capable of bending radially outward to accommodate the mesh tube through the opening. The insertion tip may be coupled to a proximal cannula, wherein the insertion tip and the proximal cannula are separable from first elongate member, wherein the proximal cannula is configured to fit over the first elongate member when the mesh tube is extended through the opening of the insertion tip. The insertion tip may include a distal portion that is coupled to the second elongate member by a tether, and a proximal portion that is coupled to first elongate member, wherein the distal portion of the insertion tip is farther away from the proximal portion of the insertion tip when the mesh tube is in the extended configuration compared to when the mesh tube is in the retracted configuration. The insertion tip may be made of a different material than the first elongate member. The insertion tip may be made of a different polymer material than the first elongate member. The mesh tube may be configured to invert at an inversion region of the mesh tube as the mesh tube is extended from or retracted into the lumen of the first elongate member. The mesh tube may have a tubular shape. The first end of the mesh tube may be coupled to the first elongate member, and a second end of the mesh tube may be coupled to the second elongate member. The first elongate member may have a tubular shape. The second elongate member may be a rod. The second elongate member may have a tubular shape.

[0034] In general, any of the drain apparatuses described herein may be generically referred to as simply “devices” or “drains.” Alternatively, these apparatuses may be referred to for convenience as “medical drains” or “surgical drains.” It should be understood that these apparatuses (devices, systems, etc., including drains) are not limited to surgical use. With respect to use within the body, these apparatuses may be particularly useful for draining blood, e.g., postpartum, following a surgery or injury, etc., but may be used in other regions of the body, or for other uses, including the bladder (e.g., for removing urine, etc.), or the like.

[0035] In some examples, a method of draining a body cavity accessible through a channel includes: penetrating a body orifice of the channel that leads to the body cavity with an insertion tip of a medical drain, wherein the insertion tip is coupled to a distal end of a first elongate member, the insertion tip having a rounded distal end and a tapered outer surface that are configured for atraumatic entry into the body orifice; positioning the insertion tip within the channel to create a seal between the insertion tip and walls of the channel; extending a mesh tube distally through the first elongate member and an opening of the insertion tip into the body cavity; and applying suction through the first elongate member so that fluid passes proximally through a plurality of flow paths of the mesh tube and proximally through the first elongate member.

[0036] At least a portion of the insertion tip may have a larger outer diameter than an outer diameter of the first elongate member. The insertion tip may taper from a larger diameter at a proximal portion of the insertion tip to a smaller diameter at a distal portion of the insertion tip. The insertion tip may include a distal portion that is coupled to a second elongate member, and a proximal portion that is coupled to first elongate member, wherein extending the mesh tube distally comprises pushing the distal portion away from the proximal portion of the insertion tip when the mesh tube is in an extended configuration compared to when the mesh tube is in a retracted configuration. The distal portion may be coupled to the second elongate member via a tether. The opening may be located on a side of the insertion tip, wherein the insertion tip includes a mesh tube channel that terminates at the opening, and wherein the mesh tube channel defines a path that is non-parallel to a central axis of the insertion tip. Extending the mesh tube distally may include causing multiple flexible sections of the insertion tip to bend radially outward to accommodate the mesh tube through the opening. The insertion tip may be coupled to a proximal cannula, wherein the insertion tip and the proximal cannula are separated from first elongate member when the insertion tip penetrates the body orifice and is advanced into the channel, wherein the first elongate member is positioned with the proximal cannula when the mesh tube is extended distally through the opening of the insertion tip. The mesh tube may have a tubular shape, wherein extending the mesh tube distally into the body cavity causes the mesh tube to invert. Extending the mesh tube distally into the body cavity may cause the mesh tube to expand within the body cavity. Extending the mesh tube distally from the first elongate member may include pushing a second elongate member that is coupled to the mesh tube through the first elongate member. The suction may cause the body cavity to contract, thereby reducing hemorrhaging. The body cavity may be a postpartum uterus, and the channel may be a nondilated or minimally dilated uterus. The mesh tube may include a tubular core surrounded by a tubular sheath, wherein at least the tubular sheath comprises braided fibers. The tubular sheath and the tubular core may each include braided fibers, wherein the tubular sheath and the tubular core have one or more of the following differences: different fiber diameters, different braid densities, different pick counts, and different fiber shapes. The tubular sheath may have a smoother outer surface than the tubular core. The method may further include removing a blood clot from the mesh tube by pulling the mesh tube proximally toward a portion of the insertion tip that forces the blood clot off the mesh tube, and extending the mesh tube distally back into the body cavity.

[0037] It should be appreciated that all combinations of the foregoing concepts and additional concepts discussed in greater detail below are contemplated as being part of the inventive subject matter disclosed herein and may be used to achieve the benefits described herein. [0038] The process parameters and sequence of steps described and/or illustrated herein are given by way of example only and can be varied as desired. For example, while the steps illustrated and/or described herein may be shown or discussed in a particular order, these steps do not necessarily need to be performed in the order illustrated or discussed. The various example methods described and/or illustrated herein may also omit one or more of the steps described or illustrated herein or include additional steps in addition to those disclosed.

[0039] All of the methods and apparatuses described herein, in any combination, are herein contemplated and can be used to achieve the benefits as described herein.

BRIEF DESCRIPTION OF THE DRAWINGS

[0040] A better understanding of the features and advantages of the methods and apparatuses described herein will be obtained by reference to the following detailed description that sets forth illustrative embodiments.

[0041] FIGS. 1 A-1D illustrates an example use of an apparatus (e.g., configured as a suction drain) in a soft tissue region of a body: FIG. 1 A shows a first cross sectional view of the soft tissue region; FIG. IB shows a second cross sectional view of the soft tissue region; FIG. 1C shows the medical drain after a mesh tube is inserted within the body region and as a negative pressure is applied; and FIG. ID shows the mesh tube in the body region after the body region is at least partially contracted.

[0042] FIGS. 2 A and 2B illustrate side views of an example medical drain with an extendable shaped tip: FIG. 2 A shows the drain in a retracted configuration; and FIG. 2B shows the drain in an extended (e.g., deployed) configuration.

[0043] FIGS. 3A-3C illustrate side views of an example medical drain with a deflectable shaped tip: FIG. 3A shows the drain in a retracted configuration; FIG. 3B shows the drain in an extended (e.g., deployed) configuration; and FIG. 3C shows a closeup view of the insertion tip.

[0044] FIGS. 4A-4C illustrate side views an example medical drain with a shaped tip with a mesh tube deployment channel: FIG. 4 A shows the drain in a retracted configuration; FIG. 4B shows the drain in an extended (e.g., deployed) configuration; and FIG. 4C shows a closeup view of the insertion tip.

[0045] FIGS. 5A-5D illustrate side views of an example medical drain with a shaped deformable tip: FIG. 5 A shows the drain in a retracted configuration; FIG. 5B shows a closeup view of the insertion tip with retracted mesh tube; FIG. 5C shows the drain in an extended (e.g., deployed) configuration; and FIG. 5D shows a closeup view of the insertion tip with a deployed mesh tube.

[0046] FIGS. 6 A and 6B illustrate side views of an example medical drain with a shaped tip that is coupled with an insertion cannula: FIG. 6A shows the insertion tip and cannula separated from a remaining portion of the drain in a retracted configuration; and FIG. 6B shows the insertion tip and cannula coupled to the remaining portion of the drain in an extended (e.g., deployed) configuration.

[0047] FIGS. 7 A and 7B illustrate side views of an example medical drain with a shaped tip with a tethered cap configuration: FIG. 7A shows the drain in a retracted configuration; and FIG. 7B shows the drain in an extended (e.g., deployed) configuration.

[0048] FIGS. 8A-8C illustrate section views of an example medical drain with rolling mesh tube configuration: FIG. 8A shows the mesh tube in a fully extended configuration; FIG. 8B shows the mesh tube in an extended double-walled configuration; and FIG. 8C shows the mesh tube in a retracted/withdrawn configuration.

[0049] FIG. 9 is a flowchart illustrating an example method of treating a body region using a medical drain.

[0050] FIGS. 10A-10B illustrate an example of how a medical drain may be used to clear blood clots from the mesh tube: FIG. 10A shows a side view of the drain in an extended configuration; and FIG. 10B shows a closeup side view of a region of the drain where blood clots may accumulate.

[0051] FIGS. 11 A-l 1C illustrate various views of an example mesh tube having a layered tubular configuration: FIG. 11 A shows a perspective front view; FIG. 1 IB shows another perspective front view; and FIG. 11C shows a perspective side view.

DETAILED DESCRIPTION

[0052] The apparatuses (e.g., devices, systems, etc.) and methods described herein relate to drains (e.g., medical drains) for removing fluid (e.g., blood, lymph, pus, etc.) and/or other material from a wound or body cavity. The medical drains may be configured as suction (e.g., negative pressure) drains that can generate and sustain negative pressure within soft tissue or a body cavity. These drains may include features well suited for use in treatment for postpartum hemorrhage. For example, the drains may include a shaped insertion tip for insertion into the cervix, for example, a non-dilated or minimally dilated cervix (e.g., after a caesarean section). The tip may have shape for atraumatic insertion into the cervix and for creating a seal with walls of the cervix. [0053] The medical drains may include a compliant mesh tube (e.g., “mesh tube”) material that is disposed within an elongate member (e.g., tube or catheter). The mesh tube may include a plurality and/or a network of pores (e.g., open cell structure) that is configured to draw fluid, air and/or solid materials from a body cavity. In some examples, the mesh tube includes a braided material. During use, the mesh tube may be extended from the elongate member and positioned within a wound or body cavity (e.g., postpartum uterus) where suction may be applied via the elongate member to drain fluid (e.g., blood, lymph, pus, etc.) from the wound or body cavity. In some cases, the mesh tube is tubular in shape and is configured to invert as it is extended out of and/or into the elongate member. In other cases, the mesh tube has a non-tubular shape (e.g., cylindrical shape, flat sheet, etc.). The negative pressure may also cause the body cavity (e.g., postpartum uterus) to contract, thereby reducing hemorrhaging. Examples of negative pressure medical drains with invertible mesh tube are described in U.S. Patent Application Publication No. 2023/0241303, which is incorporated by reference herein in its entirety.

[0054] FIGS. 1 A-1D show an example of a medical drain used in a soft tissue region of a body. FIG. 1 A shows a first cross sectional view of the soft tissue region, which includes a cavity 120 and a channel 122 that leads to the cavity 120. The cavity 120 may be a postpartum uterus, and the channel 122 may include a portion of the vaginal canal 123 and the cervix 124. The cervix 124 may be non-dilated or minimally dilated, for example, in the case of a caesarean section. In other cases, the soft tissue region may be a surgical site or a site of removal for tumor.

[0055] FIG. IB shows a second sectional view (e.g., taken at 90 degrees offset from the view shown in FIG. 1 A). As shown, in some cases, the cavity 120 may be open more in one direction than another.

[0056] FIG. 1C shows a medical drain after being inserted within channel 122 and into the body cavity 120. The medical drain includes a first elongate member 110 having an insertion tip 102 having a tapered shape to facilitate insertion into the channel 122. For example, in the case of a postpartum uterus, the insertion tip 102 can be positioned through the external orifice of the cervix and into the cervix. In the case of a non-dilated or minimally dilated cervix, which is smaller than a dilated cervix, the insertion tip 102 can be sized to fit within the cervix and form a seal with walls of the cervix.

[0057] A mesh tube 108 is extended distally out of the first elongate member 110, through an opening of the insertion tip 102, and into the body cavity 120. In some examples, this involves pushing a second elongate member 112, which is coupled with the mesh tube 108, through the first elongate member 110. In other examples, the second elongate member 112 is not used or present, and the mesh tube 108 may be pushed directly through the first elongate member 110.

[0058] Once the mesh tube 108 is deployed within the cavity 120, a negative pressure may be applied through the lumen of the first elongate member 110 and/or the second elongate member 112 to cause fluid, gas and/or other bodily material from the cavity 120 to flow proximally through the mesh tube 108, into the first elongate member 110, and eventually out of the cavity 120. For example, the proximal end of the first elongate member 110 and/or the second elongate member 112 may be operationally coupled to a vacuum source for applying a vacuum through the lumen of the first elongate member 110 and/or the second elongate member 112 and the mesh tube 108. The mesh tube 108 may have a porous structure (e.g., open pore structure) that creates multiple flow paths for the fluid, gas and/or solid material to pass through the mesh tube 108 and into the first elongate member 110. In some examples, the first elongate member 110 may include one or more openings at the distal end and/or side walls of the first elongate member 110 for the fluid, etc. to flow through.

[0059] The first elongate member 110 may be any appropriate length so that it may be manipulated and position the mesh tube 108 within the body region being treated. For example, the first elongate member 110 may be between 5 cm and 100 cm long (e.g., between 10 cm and 50 cm, between 10 cm and 35 cm, between 10 and 30 cm, etc.). The first elongate member 110 may be straight (as shown) or curved, including curved with a fixed curve (e.g., between 10-80 degrees). In some cases, the first elongate member 110 and/or second elongate member 112 may be laterally flexible.

[0060] In some cases, the second elongate member 112 (if present) may extend distally at least partially within the mesh tube 108. In other cases, the second elongate member 112 does not extend distally within the mesh tube 108. In some examples, the second elongate member 112 may be concentrically arranged within the first elongate member 110, and may be coupled to one end of the mesh tube 108. The mesh tube 108 may be radially compressible such that the outer diameter of the mesh tube 108 can be compressed for entry into the first elongate member 110. In some cases, the mesh tube 108 may have a sufficient column stiffness and bending stiffness to provide adequate flow through a cross section of the mesh tube 108.

[0061] In some examples the mesh tube 108 may be compressed into a compressed state within the first elongate member 110. Once released from the first elongate member 110 and extended within the cavity 120, the mesh tube 108 may expand into an expanded state. In some cases, the mesh tube 108 may be configured to take on a pre-determined shape (e.g., bent shape), for example, to conform to a shape of a particular body cavity. [0062] In some examples, the first elongate member 110 and/or the second elongate member 112 may include one or more stops that limit their relative axial movement. For example, the first elongate member 110 and the second elongate member 112 may be configured to lock with respect to each other when the mesh tube 108 extends distally and/or retracts proximally by a predetermined amount. In some examples, the drain includes one or more locks configured to releasably lock the relative axial positions of the first elongate member 110 and the second elongate member 112.

[0063] The negative pressure can be maintained within the cavity 120 since a seal is formed between the insertion tip 102 and the walls of the channel 122 (e.g., cervix 124). The negative pressure may create an inward force on the surrounding walls of the cavity 120 (indicated by inward facing arrows in FIG. 1C), thereby causing the body cavity 120 (e.g., uterus) to at least partially contract, as shown in FIG. ID. Such contraction may be beneficial, for example, in cases where contracting a postpartum uterus may reduce hemorrhaging. The mesh tube 108 can maintain a shape that provides efficient flow of fluid, gas and/or other bodily material through the network of pores of the mesh tube 108, even when compressed by the tissue, as shown in FIG. ID.

[0064] The negative pressure may be maintained for a period of time to provide a therapeutic benefit. For example, the negative pressure may be applied until the cavity 120 is sufficiently drained of fluid and/or the cavity 120 is sufficiently contracted. In some examples, the period of time may range from one minute to several hours or even days. For example, the period of time may range from one minute to 5 days or more (e.g., 10 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, or 10 hours, 12 hours, 18 hours, 24 hours, 48 hours, 3 days, 4 days, 5 days, etc.). For example, when treating postpartum bleeding, these apparatuses may maintain pressure for 0.5 to 10 hours (e.g., 0.5 to 9 hours, 0.5 to 8 hours, etc.); for treating breast reconstruction, bladder, chest tube, lung drainage, etc. these periods may be even longer.

[0065] After treatment is complete, the mesh tube 108 may be removed from the cavity 120 by proximally moving the mesh tube 108 out of the cavity 120. For example, the second elongate member 112 (if present) may be pulled proximally to retract the mesh tube 108 within the first elongate member 110. The entire device can be pulled out of the cavity 120 and channel 122. In other examples (e.g., where the second elongate member 112 is not used), the first elongate member 110 may be pulled to directly pull the mesh tube 108 and the entire device out of the cavity 120.

[0066] FIGS. 2A and 2B illustrate one example of a medical drain device. In this example, the device includes a first elongate member 210 having a suction lumen 211 extending along the length, in fluid communication with a suction port, (e.g., inlet 220 on the handle portion 218) and a distal suction opening 213. The device also includes a second elongate member 212 that is movably disposed in the suction lumen of the first elongate member, and is connected to a second handle portion 216. The device also includes a tapered insertion tip 202 at a distal end of the first elongate member. The tapered insertion tip having a distally tapered outer surface 206 and a suction opening therethrough. The device also includes a mesh tube 208 that is coupled to the second elongate member. The mesh tube is configured to transition between a retracted configuration (shown in FIG. 2A) in which the mesh tube is retracted proximally into the suction lumen of the first elongate member, and an extended configuration (shown in FIG. 2B), in which the mesh tube is extended distally past the suction opening of the tapered insertion tip, by moving the second elongate member relative to the first elongate member. In the extended configuration the mesh tube may be configured to provide a plurality of flow paths for fluid to flow to the suction opening when suction is applied from the suction opening. This may be facilitated by the plurality of lengths of filaments forming the mesh.

[0067] The medical drain devices described herein may include features, such as a shaped (e.g., tapered) insertion tip, that are well suited for treatment of postpartum hemorrhage in cases where the cervix is non-dilated or minimally dilated, such as in the case of caesarean sections. In FIGS. 2A and 2B the drain 200 includes a tapered insertion tip 202. The tip 202 may have a tapered shape that facilitates insertion through a non-dilated or minimally dilated cervix. The distal portion extending from the tip may be part of the tip or may be part of a second tip that is connected to a second elongate member 212 (as shown in FIGS. 2A-2B). For example, a distal portion 204 from the tip may have a smaller diameter than a proximal portion 221 of the tip 202. The distal portion 204 from the tip in this example has a rounded distal end that is configured for atraumatic contact with soft tissue (e.g., of the cervix). For example, the rounded distal end of the distal portion 204 from the tip may be sufficiently blunted (not too sharp) so as to reduce the risk of injury (e.g., puncture) to tissue, but tapered enough to allow penetration into a body orifice (e.g., external cervical orifice) in a manner that reduces injury to the tissue as the device is advanced through the body orifice. The tip 202 has a tapered shape where its diameter gets gradually smaller going from its proximal end toward its distal end. The tip 202 may have a smooth outer surface so as to reduce friction against tissue.

[0068] The diameters of the insertion tip 202 and the first elongate member 210 may be smaller in examples that are used in a non-dilated or minimally dilated cervix (e.g., after caesarean section) compared to examples that are used in dilated cervix (e.g., after vaginal birth). For example, the diameter of the narrower tapered portion of the insertion tip 202 and the first elongate member 210 may be small enough to fit within an orifice (e.g., non-dilated or minimally dilated cervix) having a 4 centimeter (cm) diameter or smaller (e.g., 3.5 cm or smaller, 3 cm or smaller, 2.5 cm or smaller, 2 cm or smaller, 1.5 cm or smaller, etc.). In some examples the diameter is tapered (and less than 1 mm, less than 2 mm, less than 3 mm, etc.) at the tip; the tip may be atraumatic (e.g., rounded) or protected. In some examples, the diameter of the first elongate member 210 may range from 3 French scale (Fr) to 10 Fr (e.g., between 3F and 9 F, between 3F and 8F, between 4F and 7F, between 3F and 6F, etc.). The tip 202 may have a larger diameter than the first elongate member 201 so that the tip 202 can create a seal with the walls of a non-dilated or minimally dilated cervix. In some examples, the outer diameter of the widest part 221 of the insertion tip 202 may range between 60 Fr and 110 Fr (e.g., between 70F- 115F, between 80F-110 F, between 85F and 100F, between 85F and 95F, etc.).

[0069] As mentioned, the medical drain 200 includes a first elongate member 210 and a second elongate member 212 that is configured to slide within a lumen of the first elongate member 210. The proximal portion 221 of the tip 202 is coupled to a distal end of the first elongate member 201. The distal portion 204 of the tip 202 is coupled to a distal end of the second elongate member 212. The second elongate member 212 is also coupled to a mesh tube 208. FIG. 2 A shows the medical drain 200 in a retracted configuration, where the second elongate member 212 and the mesh tube 208 is retracted within the first elongate member 210. In FIG. 2B, the second elongate member 212 and the mesh tube 208 are extended distally with respect to the first elongate member such that the mesh tube 208 is exposed (out of the first elongate member 210).

[0070] The medical drain 200 may be in the retracted configuration (FIG. 2A) during insertion into a body cavity. A user may hold a proximal portion 218 of a handle 214 of the medical drain 200 and push the tapered insertion tip 202 into a body orifice (e.g., external orifice of a non-dilated or minimally dilated cervix) of a body channel (e.g., cervix). Once the tip 202 is positioned within and creates a seal the body channel (e.g., cervix), a second portion 216 of the handle 214 may be advanced distally relative to the proximal portion 218 of the handle 214 to cause second elongate member 212 to slide distally within the first elongate member 210 and extend the mesh tube 208 out of the first elongate member 210 (FIG. 2B) into a body cavity (e.g., uterus). Suction may be applied through the first elongate member 210 via an inlet/outlet 220 (e.g., fitting) connected to a vacuum source.

[0071] The insertion tip 202 and the first elongate member 210 may be made of any of a number of materials. In some examples, the insertion tip 202 is made of a different material than the first elongate member 210. For example, the insertion tip 202 may be made of a polymer material and the first elongate member 210 is made of a silica-based material (e.g., glass). In some examples, the insertion tip 202 and the first elongate member 210 may both include polymer, but be made of different types of polymers (e.g., different polymer compositions). The insertion tip 202 may be a hard or soft polymer (e.g., having a durometer of between about 10 to 70 in the Shore A scale, e.g., between about 10-50 Shore A, between about 20-30 Shore A, etc. In some examples the elongate member is made from a clear polymer suck as thermoplastic urethane or PVC (having a Shore A durometer in the range of about 50 to 75, about 60-75, about 65-75, etc.). The first elongate member 210 can be made from a non-clear polymer (e.g., a translucent or opaque polymer), having durometer of between about 50 to 75, about 60-75, about 65-75, etc.

[0072] In some cases the device may include a mesh tube that is configured to extend distally out of the suction opening while the second elongate member driving it in/out of the first elongate member remains within the elongate member. For example, FIGS. 3A-3C show another example medical drain 300 with a shaped insertion tip 302. The medical drain 300 has similar features (e.g., first elongate member 310, second elongate member 312, mesh tube 308 and handle 314) as the medical drain 200 of FIGS. 2A-2B. In addition, like the medical drain 200, the medical drain 300 has an insertion tip 302 having a rounded distal end and a tapered shape for atraumatic entry into a body channel (e.g., into a non-dilated or minimally dilated cervix). However, in the example medical drain 300, the insertion tip 302 is deflectable. The insertion tip 302 includes a distal portion 304 that is configured to deflect (e.g., pivot) with respect to a proximal portion 306 of the insertion tip 302.

[0073] The handle 314 may be used to transition the medical drain 300 between the retracted configuration (FIG. 3 A) to an extended configuration (FIG. 3B). FIG. 3 A shows the medical drain 300 in a retracted configuration where the mesh tube 308 is retracted within the first elongate member 310. When in the retracted configuration, the distal portion 304 of the insertion tip 302 is axially aligned with the proximal portion 306 of the insertion tip 302. FIG. 3B shows the medical drain 300 in an extended configuration after the second elongate member 312 pushed the mesh tube 308 through and out the distal end of the first elongate member 310. FIG. 3C shows a closeup view of the insertion tip 302 in a deflected state, where the distal portion 304 of the insertion tip 302 is deflected with respect to the proximal portion 306 of the insertion tip 302. In this example, the distal portion 304 is connected to the proximal portion 306 via a hinge portion 305. In general, the first elongate member 310 may have a smaller diameter than the first elongate member 210 in relative to the distal tips 302/310 or it may be the same diameter. [0074] FIGS. 4A-4C show another example medical drain 400 with a shaped insertion tip 402. The medical drain 400 has similar features (e.g., first elongate member 410, second elongate member 412, mesh tube 408, handle 414 and tapered insertion tip 402) to the medical drains 200 and 300. However, the insertion tip 402 includes a mesh tube deployment channel 405 that defines an opening on the outer surface of the insertion tip 402. In this example, the opening of the channel 405 is a side-facing opening and leads to a channel within the insertion tip 402 that defines a path that is non-parallel to a central axis of the insertion tip 402. This arrangement will allow the distal end of the insertion tip 402 to have a rounded shape for atraumatic contact with body tissue. Pushing the second elongate member 412 pushes the mesh tube 408 through the channel 405 and out of the side-facing opening. The channel 405 can be angled (e.g., towards the central axis of the insertion tip 402) such that the mesh tube 408, when deployed, can extend mostly in a direction parallel to (or near parallel to) the central axis of the insertion tip 402 and the first elongate member 410.

[0075] FIGS. 5A-5D show another example medical drain 500 with a shaped insertion tip 502. The medical drain 500 has similar features (e.g., first elongate member 510, second elongate member 512, mesh tube 508, handle 514 and tapered insertion tip 502) to the medical drains 200, 300, and 400. However, the insertion tip 502 is deformable. The insertion tip 502 includes a distal portion 506 and a proximal portion 507. The distal portion 506 includes multiple flexible sections 509 that are capable of bending radially outward to accommodate the mesh tube 508 through the opening 505. In this example, the distal portion 506 includes four expandable sections 509, but may include any number expandable sections (e.g., 1, 2, 3, 4, 5, 6, 7, 8 or more expandable sections). The distal portion 506 can maintain a tapered shape (e.g., a default configuration), as shown in FIGS. 5A and 5B, when the medical drain 500 is in a retracted configuration and the mesh tube 508 is retracted within the first elongate member 510. When the mesh tube 508 is extended through the insertion tip 502, as shown in FIGS. 5C and 5D, the sections 509 expand radially to accommodate the diameter of the mesh tube 508.

[0076] Any of these apparatuses may be configured so that the insertion tip is separate from the drain, so that it may be used to adapt a drain without a tapered insertion tip for use in a smaller diameter orifice (e.g., an un-dilated or partially dilated cervix). For example, FIGS. 6A-6B shows an example of an apparatus including an insertion tip that is removably attachable to a separate drain apparatus and is configured to be inserted over the separate drain apparatus.

[0077] In FIGS. 6 A and 6B the apparatus 600 includes an adapter 609 including the tapered insertion tip 602 and a cannula body 611. The apparatus 600 include a separate drain with similar features (e.g., first elongate member 610, second elongate member 612, mesh tube 608, handle 614, etc.) to the medical drains 200, 300, 400 and 500. However, the insertion tip 602 is coupled to an insertion cannula 609. and the insertion cannula 609 and tip 602 are separable from drain device and can be coupled to the first elongate member 610. The insertion cannula 609 includes an elongated portion 611 that defines an inner lumen and that is configured to fit around the first elongate member 610. In the example shown, the cannula 609 also includes a proximal flange 613.

[0078] The insertion tip 602 and cannula 609 assembly may be configured to be inserted without being attached to the remaining part of the medical drain 600 (e.g., first elongate member 610, second elongate member 612, mesh tube 608, and handle 614). For example, a practitioner may hold the cannula 609 by hand and insert the insertion tip 602 into the body channel (e.g., cervix). Once the insertion tip 602 is positioned within the body channel (e.g., cervix), the first elongate member 610 (with the mesh tube 608 housed therein) may be inserted into the cannula 609. Then, the mesh tube 608 may be deployed, as shown in FIG. 6B.

[0079] The example medical drain 600 includes a deformable insertion tip 602 similar to the deformable insertion tip 500 of FIGS. 5A-5D. That is, the insertion tip 602 includes a deformable distal portion 605 and a proximal portion 607. However, any of the insertion tip configurations described herein may be coupled to an insert cannula (e.g., cannula 609). For example, the cannula 609 may be coupled to an extendable tip (e.g., extendable tip 200), a deflectable tip (e.g., deflectable tip 300), or a tip having a mesh tube deployment channel (e.g., tip 400).

[0080] In some examples even when the mesh tube is configured to invert and roll out of the suction lumen (as shown in FIGS. 3A-3B, 4A-4B, 5A-5D, and 6A-6B), the second elongate member may include a distal member, e.g., a cap, that may be configured to provide an atraumatic surface at the distal end, e.g., to cover the suction lumen opening when not deployed. The cap may be a sphere/hemi sphere, capsule, etc. that may extend from the second elongate member and through the inverted mesh tube. For example, FIGS. 7 A and 7B show an example medical drain 700 with a shaped insertion tip 702. The medical drain 700 has similar features (e.g., first elongate member 710, second elongate member 712, mesh tube 708, handle 714, and tapered insertion tip 702) to the medical drains 200, 300, 400, 500 described above. However, the insertion tip 702 includes a tethered cap 705. The distal tethered cap 705 may be separable from the insertion tip 702 or coupled with and/or integral with the insertion tip. The insertion tip 702 may have a tapered side surface 707. When the medical drain 700 is in a retracted configuration (FIG. 7A), the distal cap 705 contacts the distal portion of the tapered insertion tip to form an atraumatic insertion surface that can be inserted into the body channel (e.g., cervix). When the mesh tube 708 is deployed from the insertion tip 702 (FIG. 7B), the distal cap 705 remains tethered to the medical drain 700 via tether 709. The tether 709 may be coupled to the second elongate member 712 or the mesh tube 708. After the body cavity (e.g., uterus) is sufficiently drained, the handle 714 can be used to pull the second elongate member 712 and the mesh tube 708 back into the first elongate member 710, bringing the distal cap 705 back into contact with the proximal portion of the insertion tip 702.

[0081] As mentioned, any of the medical drains described herein may include mesh tube that is in a rolling invertible tubular configuration. FIGS. 8A-8C show an example of a medical drain 800 with a rolling invertible tubular mesh tube 806. A first end of the mesh tube 806 is coupled to a distal end region of a first elongate member 802, and a second end of the mesh tube 806 is coupled to a distal end region of a second elongate member 804. The lumen of the first elongate member 802 forms the vacuum channel extending from, e.g., a proximal vacuum port to one or more distal openings at the distal end of the first elongate member 806. As described herein, vacuum port may be configured to connect to a source of negative pressure (e.g., vacuum). In some examples the vacuum port may be a mating connection (a sealing mating connection) to couple to tubing for connecting to the source of negative pressure. In some cases the vacuum port may include a lock (e.g., luer-type lock) for opening/closing (to allow on/off of the negative pressure, and/or to maintain or hold the pressure already applied).

[0082] FIG. 8A shows the medical drain 800 in an extended configuration where the second elongate member 804 has been pushed distally relative to the first elongate member 802 to almost fully extend the mesh tube 806 distally except for at an inversion region 803 at a distal end of the mesh tube 806. This configuration may be over extended; in any of these apparatuses described herein, the apparatus may be configured (e.g., by controlling the length of the second elongate member, for example) to prevent the second elongate member from extending distally out of the first elongate member. For example, the maximum extended configuration may instead be similar to that shown in FIG. 8B. In this extended configuration, the mesh tube 806 may take on a tubular shape. Optionally, in some configurations the mesh tube 806 may radially expand when released from the first elongate member 802. The inversion region 803 may define an inversion plane 814 along which the tubular mesh tube inverts. In this case, the inversion plane 814 is at a perpendicular angle with respect to the longitudinal axis of the first elongate member 802. In other examples, the inversion plane 814 may be configured to be at a non-perpendicular angle with respect to the longitudinal axis of the first elongate member 802.

[0083] From the extended state in FIG. 8A or 8B, the second elongate member 804 may be pulled proximally to cause the mesh tube 806 to fold onto itself along the inversion region 803 as it is retracted within a distal opening 801 of the first elongate member 802. The walls of the mesh tube 806 may be doubled back, forming a double-walled tubular shape that defines a second lumen 820 formed by mesh tube 806. In some cases, the medical drain 800 may be configured to apply suction such that fluid and/or body material flows into the second lumen 820 and out of the mesh tube 806 in the proximal direction. In the example shown in FIG. 8B, the second elongate member 804 is withdrawn proximally past the distal end 809 of the first elongate member 802, which may allow the portion 815 of the mesh tube 806 that extends outside of the first elongate member 802 to have more lateral flexibility (e.g., compared to when the second elongate member 804 is distally extended past the distal end 809 of the first elongate member 802). This may allow the mesh tube 806 to bend laterally more easily during use, for example, as it contacts tissue walls within the body cavity. In some examples, a distal end of the second elongate member 804 is positioned near the distal end 809 of the first elongate member 802 to maximize a length of the mesh tube 806 in the double-walled tubular configuration. As mentioned, the distal end of the mesh tube 806 coupled to the outer elongate member 802 may be coupled to an inner surface of the lumen rather than an outer surface.

[0084] FIG. 8C shows the medical drain 800 as the second elongate member 804 is pulled further proximally such that the mesh tube 806 is almost fully inverted and withdrawn within the first elongate member 804, thereby mostly taking on a tubular shape that is inverted (compared to the non-inverted mostly tubular state in FIG. 8A). In FIG. 8C the mesh tube is shown coupled to the outside of the first elongate member; in some cases the mesh tube may instead be coupled to the inside (e.g., within the suction lumen) of the first elongate member.

[0085] The medical drain 800 may be configured to apply a negative pressure on the medical drain 800 at any state of mesh tube 806 extension/inversion. For example, it may be beneficial to apply suction when the mesh tube 806 is almost fully extended distally (e.g., FIG. 8A or FIG. 8B) to access more distal regions of a body cavity. Alternatively or additionally, it may be beneficial to apply suction when the mesh tube 806 is in a doublewalled state (e.g., FIG. 8B) where the mesh tube 806 may be more flexible due to the second elongate member 802 being withdrawn, thereby allowing the mesh tube 806 to conform easier to the geometry of a body cavity. [0086] In some cases, the first elongate member 802 and/or the second elongate member 804 may include one or more stops and/or locks to limit their relative axial movement and/or lock their relative axial positions. For example, the mesh tube 806 may be stopped and/or locked in the double-walled tubular configuration, such as shown in FIG. 8B and/or prevented from extending further, as mentioned. Additionally or alternatively, the mesh tube 806 may be stopped and/or locked in a distally extended configuration where the second elongate member 804 is distally extended with respect to the first elongate member 802, such as shown in FIG. 8A, and/or in a withdrawn configuration where the mesh tube 806 is inverted and withdrawn into the lumen of the first elongate member 802, such as shown in FIG. 8C.

[0087] As mentioned above and shown in FIGS. 2A-2B, the medical drain may include a mesh tube that is not configured to invert and roll. For example, the mesh tube may have tubular shape that is not configured to invert. In other examples, the mesh tube may have a non-tubular shape.

[0088] Any of the mesh tubes described herein may have an open pore structure in which pores/holes/spaces within a mesh tube are interconnected to provide multiple channels throughout the mesh tube. In some examples, the mesh tube includes a porous material (e.g., fabric and/or textile), which may include woven, knitted or braided elements (e.g., filaments). In some examples, the mesh tube may be formed of a knit, a weave, a braid, a non-woven sheet (e.g., polymer or metallic or mixes), or a flexible tube of material having pores. For example, in variations in which the mesh tube is formed of a braided material, the braid may include any number of filaments, e.g., between 24-144 ends/filaments (e.g., between about 24-128 filaments, between about 32-98 filaments, etc.). In some examples, the filaments are formed of a material such as PET, Nylon, PP, Nitinol, Steel, Elgiloy, or some combination of these. The filament may be any appropriate diameters, such as between 0.003” to 0.025” diameter filaments (e.g., monofilaments or compound filaments). In some examples, the mesh tube is formed of filaments (knit, woven, braided, etc.) of between 100-2000 denier (e.g. multifilament or monofilament). The mesh tube may have a mono or multi filament structure (or a mixture thereof).

[0089] In some examples, the mesh tube is made of a non-woven material, such as a punched material, slitted material, felt, melt blown material and/or foam material. For example, the mesh tube may be formed by extrusion, punching, stamping, blowing, laser cutting and/or other manufacturing techniques. In some examples, the mesh tube may include an open cell structure (e.g., open cell or reticulated foam) that includes interconnected holes/spaces (e.g., cells). In some cases, the foam is similar to some types wound dressing foams used with negative pressure. In some cases, the foam may be reinforced with an open textile structure (e.g., net-like tubes, sheets) to hold the foam together when placed under tension. For example, the foam may be a composite foam, or a fabric covered foam. In some examples, the mesh tube includes a pore pattern, for example, with 1 mm to 4 mm holes (e.g., like perforated structures with many holes per unit area). In some examples, the mesh tube includes a pattern of slits, for example, with slits with 1 mm width to 3 mm width by 1 mm length to 15 mm length.

[0090] The mesh tubes described herein may be made of any of a number of biocompatible materials. In some examples, the mesh tube includes one or more polymers, such as polyethylene terephthalate (PET), polytetrafluoroethylene (PTFE), silicone and/or polyurethane. In some cases, the PTFE is an expanded polytetrafluoroethylene (ePTFE). In some cases, the polymer includes a thermoplastic or thermoset material (e.g., thermoplastic or thermoset foam). In some examples, the mesh tube includes one or more metals (e.g., metal filaments), such as nickel titanium alloy (e.g., nitinol), steel, Elgiloy and/or nickel -cobaltchromium -molybdenum alloy (e.g., MP35N).

[0091] The term “mesh” (e.g., in mesh tube) is not limited to structures formed by one or more strands, but may be formed of a non-woven material. The material forming the mesh tube may be a porous filtering material such as Tyvek, filter paper, etc. or it may be (initially) non-porous and pores may be formed therein. The term “mesh” may refer to a material having an average porosity of greater than, e.g., 50%.

[0092] In any of the apparatuses described herein, the mesh tube may be made of a flexible porous material. In some examples, the mesh tube may be a fabric. The mesh tube may be formed of filaments (e.g., strands) of material, such as monofilaments or multiple filaments. For example, the mesh tube may comprise a braided polymeric monofilament having 24 or more strands (e.g., 30 or more strands, 34 or more strands, 36 or more strands, 38 or more strands, 40 or more strands, 42 or more strands, etc.).

[0093] In some examples, the mesh tube is made of material that has particular physical characteristics. For example, the mesh tube may be made of material that is sufficiently flexible to bend laterally (e.g., when contacting soft tissue) but sufficiently rigid such that the mesh tube has a sufficiently high column stiffness to maintain a tubular shape once extended out of the elongate member. In some examples, the mesh tube material creates a smooth, slippery surface for the tissue to contact, thereby reducing damage to the tissue.

[0094] The mesh tube typically has a plurality of openings or pores where the pores are sufficiently large to allow fluids and some solid biological debris (e.g., clots, pus, coagulate) to pass easily. For example, the pores may have a pore diameter that is 0.1 mm or greater (0.2 mm or greater, 0.3 mm or greater, 0.4 mm or greater, 0.5 mm or greater, 0.6 mm or greater, 0.7 mm or greater, 0.8 mm or greater, 0.9 mm or greater 1mm or greater, 1.1 mm or greater, 1.2 mm or greater, 1.3 mm or greater, 1.4 m or greater, etc.). The pores may be formed by the spaces between the strands, e.g., in woven, braided and/or knitted mesh tube.

[0095] The mesh tube described herein may have any of a number of shapes. In some examples, the mesh tube may have a tubular shape with an inner space (e.g., lumen). The tubular shape may be open at both ends or closed at one end (e.g., the distal end, e.g., forming a bag). In some cases, the mesh tube may include multiple tubes of porous material (e.g., concentrically arranged). In some cases, the mesh tube may be shaped into a non-tubular shape.

[0096] In any of the apparatuses, the first elongate member (e.g., tube or catheter) and/or the second elongate member (e.g., rod or inner tube or catheter), may be flexible, semi-ridged or rigid. For example, the elongate member(s) may be formed of polyurethane or silicone. The medical drains may be configured to have reasonably high column force while retaining bending flexibility. For example, they may have sufficient axial flexibility so that they can be bent around structures or non-uniform volumes within soft tissue.

[0097] In any of the examples, the proximal direction may generally be in the direction towards the hand of the user (e.g., physician, surgeon, medical technician, nurse, etc.) operating the device, and distal may generally be in the direction away from the hand of the user.

[0098] FIG. 9 is a flowchart indicating an example method of draining fluid from a body cavity. In some examples, the body cavity is post-partum uterus. The method includes penetrating a body orifice (e.g., exterior orifice of the cervix) with an insertion tip of a medical drain (step 901). The insertion tip can have a rounded distal end and a tapered outer surface that are configured for atraumatic entry into the body orifice and a body channel (e.g., cervix). In some examples, the insertion tip is coupled to a distal end of a first elongate member of the medical drain when the insertion tip penetrates the body orifice and is advanced into the body channel. In other examples, the insertion tip is coupled to a cannula, where the insertion tip and the cannula are separate from the first elongate member when the insertion tip is penetrated through the body orifice and advanced into the body channel.

[0099] The method may also include creating a seal between the tip and the body channel (e.g., cervix) (step 903). The diameter of the tip may be small enough to enter the body channel, yet large enough to create a seal with the surrounding tissue of the body channel. The outer surface of the tip may be smooth so as to create a good seal. [0100] A mesh tube can be extended distally from the first elongate member through an opening of the tip and into the body cavity (step 905). In some examples, extending the mesh tube includes pushing a second elongate member that is coupled to the mesh tube through the first elongate member. In some examples, the mesh tube has a tubular shape, and extending the mesh tube distally into the body cavity causes the mesh tube to invert. In some examples, the mesh tube may be configured to expand when released from the first elongate member and take on a shape that can distribute suction throughout the body cavity. In some cases, the mesh tube is adjusted to take on a double-walled tubular configuration where the porous wall of the tubular mesh tube doubles back on itself to form a second lumen, as described herein.

[0101] Suction may be applied to through the mesh tube and the first elongate member to drain fluid proximally from the body cavity (e.g., postpartum uterus) (907). The mesh tube may be configured to provide multiple flow paths for fluid/material to flow through when the suction is applied through the first elongate member to drain the fluid/material proximally through the mesh tube and the first elongate member. The mesh tube may have pores of sufficient size to allow passage of fluids (e.g., blood, lymph, pus), gasses and/or other materials (e.g., coagulate, etc.) to pass without significant resistance. The suction may apply sufficient negative pressure to walls of the body cavity to cause the body cavity to contract, which can reduce hemorrhaging.

[0102] In some cases, the suction may optionally be maintained for a period of time (step 909). For example, it may take time for the negative pressure to cause the walls of the body cavity (e.g., uterus) to contract and mitigate hemorrhaging. However, it may not be desirable to keep the mesh tube within the body cavity for too long in order to prevent tissue adhesion to the mesh tube. In some examples, the suction may be maintained for between about 1 minute and 96 hours (e.g., between 24-78 hours, up to 96 hours, up to 80 hours, up to 72 hours, etc.).

[0103] Once the body cavity is sufficiently drained and the hemorrhaging sufficiently reduced, the suction may be removed and the medical drain withdrawn from the body region (e.g., body cavity, channel and body orifice) (step 911). In some cases, withdrawing the medical drain includes withdrawing the mesh tube back into the first elongate member. In cases where a second elongate member is coupled to the mesh tube, this may be accomplished by pulling the second elongate member proximally (e.g., at a handle of the medical drain). If the mesh tube is an invertible tubular mesh tube, this may cause the mesh tube to invert as it is withdrawn back into the first elongate member.

[0104] The medical drains described herein may include features for clearing blood clots and other debris from clogging the mesh tube. The FIGS. 10A and 10B illustrate an example of how a medical drain 1000 can be used to remove clots and debris. These figures show the drain 1000 in an extended configuration where the mesh tube 1008 is exposed (out of the first elongate member 1010) and a distal portion 1004 of the insertion tip 1002 is extended distally away from a proximal portion 1006 of the insertion tip 1002. If the efficiency of suction through the mesh tube 1008 is reduced due to debris (e.g., blood clots) forming within the mesh tube 1008, the user can use the handle 1014 to retract the second elongate member 1012 and the mesh tube 1008 proximally. This can force debris to clear off the mesh tube 1008 at the distal end 1050 of the proximal portion 1004 of the insertion tip 1002 as the mesh tube 1008 is retracted into the first elongate member 1010. The position of the proximal portion 1004 of the insertion tip 1002 may be maintained to keep the seal with the surrounding tissue of the cervix. Thus, the suction within the body cavity may be maintained as the mesh tube 1008 is retracted. Once the debris is sufficiently cleared, the mesh tube 1008 can be extended distally again into the body cavity to continue distributing suction throughout the body cavity. [0105] FIGS. 11 A-l 1C show various views of an example textile (e.g., mesh) member 1100 having a layered tubular configuration. The textile member 1100 may be part of any of the medical drains described herein. The textile member 1100 includes multiple layers of braided fibers (e.g., filaments, yarns, etc.). For example, the textile member 1100 includes braided fibers that make up a core 1102 and another layer of braided fibers that make up a sheath 1104. Each of the core 1102 and the sheath 1104 are tubular shaped, with the sheath 1004 surrounding the core 1102. In other examples, a textile member may include only one layer, or more than two layers.

[0106] The fibers of the core 1102 and sheath 1104 may be constructed of any of a number of materials. In some examples, the fibers of the core 1102 and/or the sheath 1104 are made of a polymer. In some examples, the polymer material is a thermoplastic polymer. In some examples, the polymer is a polyester (e.g., polyethylene terephthalate (PET)). In some examples, the fibers of the core 1102 and/or the sheath 1104 include a metal material. In some examples, the metal material is a shape-memory material (e.g., nitinol). In some examples, the fibers of the core 1102 and/or the sheath 1104 include a combination of polymer and metal materials.

[0107] The number, size, braid density and shape of the fibers in the core 1102 and the sheath 1104 may provide desired characteristics to the textile member 1100. The textile member 1100 may have sufficient column stiffness and bending stiffness to provide adequate flow through the cross section of the textile member 1100. For example, too high of a bending stiffness may reduce the flow through the cross section of the textile member 1100. A column stiffness that is too low may cause the textile member 1100 to collapse too easily when it is extended from the elongate member. The outer surface of the textile member 1100 may be sufficiently smooth to reduce abrasive contact with body tissue.

[0108] In general, the textile can be one layer or more than one layer. Although the examples shown in FIGS. 11 A-l 1C are shown as tubular, any of these apparatuses may instead use flat sheets with the same textile proprieties described above. The thickness may include one or more layer of fabric (e.g., per tube wall or sheet layer). In general, these sheet may be referred to generically as textiles (e.g., knits, braids, weave, non-woven material, including foams), or may be referred to as a mesh. In some examples, the material comprises a double-walled braid as shown in the FIGS. 11 A-l 1C with a skeleton like structure, i.e., some structure covered by a material having relatively large, open pores (e.g., pores of between about 0.5-3 mm diameter).

[0109] In the example of textile member 1100, the fibers of the sheath 1104 have a smaller diameter than the fibers of the core 1102. The smaller sheath 1104 fibers may provide a smoother outer surface to the textile member 1100 (e.g., compared to an outer surface of the core 1102) to reduce friction against tissue, thereby reducing the risk of tissue injury. The larger diameter fibers of the core 1102 may provide column stiffness and bending stiffness, and may also create larger flow paths for fluid and tissue debris to flow through. In some examples, the fibers of the core 1102 are constructed of a monofilament having a diameter ranging from about 0.01 inches to about 0.1 inches, and the fibers of the sheath are constructed of a monofilament having a diameter ranging from about 0.005 inches to about 0.05 inches.

[0110] In the example of textile member 1100, the pick count of the sheath 1104 is greater than that of the core 1102. This may help to provide a smoother outer surface to the textile member 1100 while maintaining a sufficiently high column and bending stiffness for the textile member 1100. In some examples, the core 1102 has a braid density ranging from about 1 to about 15 programmable picks per inch (PPI), and the sheath 1104 has a braid density ranging from about 5 to about 20 PPI.

[OHl] In the example textile member 1100, the end count of fibers of the sheath 1104 is greater than that of the core 1102. This may help to provide a smoother outer surface to the textile member 1100 while maintaining a sufficiently high column and bending stiffness for the textile member 1100. In some examples, the core 1102 has a fiber end count ranging from about 16 to about 48, and the sheath 1104 has a fiber end count ranging from about 32 to about 48.

[0112] In some examples, the shape of the fibers of the sheath 1104 may differ than the shape of the fibers of the core 1102. For example, in some cases, the fibers of the sheath 1104 may have a flat cross-sectional shape whereas the fibers of the core 1102 may have a round cross-sectional shape. The flatter fibers of the sheath 1104 may provide a smoother outer surface to the textile member 1100 while the rounder fibers of the core 1100 may help to maintain a sufficiently high column and bending stiffness for the textile (e.g., mesh) member 1100.

[0113] The number, size, braid density and shape of the fibers of the core 1102 and the sheath 1104 may be different than the example mesh tube 1100 presented in FIGS. 11 A-l 1C, while still providing desired characteristics (e.g., outer smoothness, column stiffness and bending stiffness). For instance, in other examples, the sheath 1104 may have the same fiber diameter, pick count, fiber end count, and/or fiber shape as the core 1102. Alternatively, the sheath 1104 may have a larger fiber diameter, smaller pick size, lesser fiber end count, and/or rounder fiber shape than the core 1102. For example, the fibers of the sheath 1104 may be made of a different (e.g., smoother) material than the fibers of the core 1102, which may allow the sheath 1104 may have a larger fiber diameter, smaller pick size, lesser fiber end count, and/or rounder fiber shape than the core 1102 while maintaining a desired smoothness, column stiffness, and bending stiffness.

[0114] In some examples, the fibers of the core 1102 and/or sheath 1104 are heat treated. Heat treatment may cause uneven shrinkage, which can create more flow channels through braid. In some examples, the braid is heat treated under axial tension before the core 1102 is inserted into sheath 1104. In some examples, the heat shrink rate of fibers of the core 1102 varies from that of the fibers of the sheath 1104.

[0115] In some examples, the braiding of the core 1102 and/or sheath 1104 is in an unbalanced arrangement for creating larger flow paths through cross section. An unbalanced arrangement is one in which the pick count and/or fiber density varies unevenly throughout the braid. For example, an un-balanced braiding may be one in which only half of ends are used in one machine direction. In some examples the core or sheath can have a different density. The core may be configured to prop open the sheath (1104) like ribs. The core may give the textile some structure, minimize bending stiffness, and provide sufficient column force to allow the device to be deployed from the elongated member.

[0116] In some examples, the fibers of the core 1102 are characterized as having a large surface roughness. This may create more flow channels within the core 1102, thereby increasing the flow capacity through the core 1102.

[0117] In some examples, the fibers of the core 1102 and/or sheath 1104 are monofilaments, such as in the example mesh tube 1100. In other examples, each of the fibers of the core 1102 and/or sheath 1104 may include multifilament fibers. For example, fibers of the sheath 1104 may include multifilament fibers to make the outer surface smooth. If braid density of the sheath 1104 is dense enough, it may also act as a microscopic filter that filters out large particles and only removes the fluid components from the cavity.

[0118] In some examples, the core 1102 and/or sheath 1104 each include multiple sublayers (e.g., two-ply, three-ply, four-ply, or more). For example, the core 1102 may include multiple sublayers to provide more column and bending stiffness.

[0119] In some examples, the core 1102 may be constructed of a non-braided material. For example, in some cases, the core 1102 may be constructed of a non-porous (solid) material. The material type and thickness of the material may be such that the mesh tube 1100 can retain some flexibility yet provide a desired column stiffness and bending stiffness to provide adequate flow. In some examples, the core 1102 is constructed of a non-porous (solid) nitinol and/or polymer (e.g., polyester) material having a thickness ranging from about 0.01 inches to about 0.04 inches.

[0120] When a feature or element is herein referred to as being “on” another feature or element, it can be directly on the other feature or element or intervening features and/or elements may also be present. In contrast, when a feature or element is referred to as being “directly on” another feature or element, there are no intervening features or elements present. It will also be understood that, when a feature or element is referred to as being “connected”, “attached” or “coupled” to another feature or element, it can be directly connected, attached or coupled to the other feature or element or intervening features or elements may be present. In contrast, when a feature or element is referred to as being “directly connected”, “directly attached” or “directly coupled” to another feature or element, there are no intervening features or elements present. Although described or shown with respect to one embodiment, the features and elements so described or shown can apply to other embodiments. It will also be appreciated by those of skill in the art that references to a structure or feature that is disposed “adjacent” another feature may have portions that overlap or underlie the adjacent feature.

[0121] Terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. For example, as used herein, the singular forms “a”, “an” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms “comprises” and/or “comprising,” when used in this specification, specify the presence of stated features, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and/or groups thereof. As used herein, the term “and/or” includes any and all combinations of one or more of the associated listed items and may be abbreviated as “/”.

[0122] Spatially relative terms, such as “under”, “below”, “lower”, “over”, “upper” and the like, may be used herein for ease of description to describe one element or feature's relationship to another element(s) or feature(s) as illustrated in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if a device in the figures is inverted, elements described as “under” or “beneath” other elements or features would then be oriented “over” the other elements or features. Thus, the exemplary term “under” can encompass both an orientation of over and under. The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly. Similarly, the terms “upwardly”, “downwardly”, “vertical”, “horizontal” and the like are used herein for the purpose of explanation only unless specifically indicated otherwise.

[0123] Although the terms “first” and “second” may be used herein to describe various features/elements (including steps), these features/elements should not be limited by these terms, unless the context indicates otherwise. These terms may be used to distinguish one feature/element from another feature/element. Thus, a first feature/element discussed below could be termed a second feature/element, and similarly, a second feature/element discussed below could be termed a first feature/element without departing from the teachings of the present invention.

[0124] Throughout this specification and the claims which follow, unless the context requires otherwise, the word “comprise”, and variations such as “comprises” and “comprising” means various components can be co-jointly employed in the methods and articles (e.g., compositions and apparatuses including device and methods). For example, the term “comprising” will be understood to imply the inclusion of any stated elements or steps but not the exclusion of any other elements or steps.

[0125] In general, any of the apparatuses and methods described herein should be understood to be inclusive, but all or a sub-set of the components and/or steps may alternatively be exclusive, and may be expressed as “consisting of’ or alternatively “consisting essentially of’ the various components, steps, sub-components or sub-steps. [0126] As used herein in the specification and claims, including as used in the examples and unless otherwise expressly specified, all numbers may be read as if prefaced by the word “about” or “approximately,” even if the term does not expressly appear. The phrase “about” or “approximately” may be used when describing magnitude and/or position to indicate that the value and/or position described is within a reasonable expected range of values and/or positions. For example, a numeric value may have a value that is +/- 0.1% of the stated value (or range of values), +/- 1% of the stated value (or range of values), +/- 2% of the stated value (or range of values), +/- 5% of the stated value (or range of values), +/- 10% of the stated value (or range of values), etc. Any numerical values given herein should also be understood to include about or approximately that value, unless the context indicates otherwise. For example, if the value “10” is disclosed, then “about 10” is also disclosed. Any numerical range recited herein is intended to include all sub-ranges subsumed therein. It is also understood that when a value is disclosed that “less than or equal to” the value, “greater than or equal to the value” and possible ranges between values are also disclosed, as appropriately understood by the skilled artisan. For example, if the value “X” is disclosed the “less than or equal to X” as well as “greater than or equal to X” (e.g., where X is a numerical value) is also disclosed. It is also understood that the throughout the application, data is provided in a number of different formats, and that this data, represents endpoints and starting points, and ranges for any combination of the data points. For example, if a particular data point “10” and a particular data point “15” are disclosed, it is understood that greater than, greater than or equal to, less than, less than or equal to, and equal to 10 and 15 are considered disclosed as well as between 10 and 15. It is also understood that each unit between two particular units are also disclosed. For example, if 10 and 15 are disclosed, then 11, 12, 13, and 14 are also disclosed.

[0127] Although various illustrative embodiments are described above, any of a number of changes may be made to various embodiments without departing from the scope of the invention as described by the claims. For example, the order in which various described method steps are performed may often be changed in alternative embodiments, and in other alternative embodiments one or more method steps may be skipped altogether. Optional features of various device and system embodiments may be included in some embodiments and not in others. Therefore, the foregoing description is provided primarily for exemplary purposes and should not be interpreted to limit the scope of the invention as it is set forth in the claims.

[0128] The examples and illustrations included herein show, by way of illustration and not of limitation, specific embodiments in which the subject matter may be practiced. As mentioned, other embodiments may be utilized and derived there from, such that structural and logical substitutions and changes may be made without departing from the scope of this disclosure. Such embodiments of the inventive subject matter may be referred to herein individually or collectively by the term “invention” merely for convenience and without intending to voluntarily limit the scope of this application to any single invention or inventive concept, if more than one is, in fact, disclosed. Thus, although specific embodiments have been illustrated and described herein, any arrangement calculated to achieve the same purpose may be substituted for the specific embodiments shown. This disclosure is intended to cover any and all adaptations or variations of various embodiments. Combinations of the above embodiments, and other embodiments not specifically described herein, will be apparent to those of skill in the art upon reviewing the above description.

Claims

CLAIMS What is claimed is:

1. A medical drain device, the device comprising: a first elongate member having a suction lumen; a second elongate member that is movably disposed in the suction lumen of the first elongate member; a tapered insertion tip at a distal end of the first elongate member, the tapered insertion tip having a distally tapered outer surface and a suction opening therethrough; and a mesh tube that is coupled to the second elongate member, wherein the mesh tube is configured to transition between an extended configuration, in which the mesh tube is extended distally past the suction opening of the tapered insertion tip, and a retracted configuration in which the mesh tube is retracted proximally into the suction lumen of the first elongate member by moving the second elongate member relative to the first elongate member, further wherein the mesh tube in the extended configuration is configured to provide a plurality of flow paths for fluid to flow to the suction opening when suction is applied from the suction opening.

2. The device of claim 1, wherein the mesh tube is coupled to the second elongate member at a proximal end region and a distal end region.

3. The device of claim 1, wherein the mesh tube is configured to transition between the extended configuration and the retracted configuration by rolling and inverting over itself.

4. The device of claim 1, wherein the mesh tube is coupled to the second elongate member at a distal end region of the second elongate member and is coupled to the first elongate member.

5. The device of claim 4, wherein the mesh tube is coupled to the first elongate member at a distal end region of the first elongate member and within the suction lumen of the first elongate member.

6. The device of claim 1, wherein the suction opening is at least partly covered by a deflectable distal region of the tapered insertion tip.

7. The device of claim 1, wherein the suction opening is a lateral opening on the tapered outer surface.

8. The device of claim 7, wherein the tapered insertion tip comprises a channel between the suction lumen and suction opening, and wherein the channel is not parallel to a central axis through the insertion tip.

9. The device of claim 1, wherein the tapered insertion tip has a larger outer diameter than an outer diameter of the first elongate member.

10. The device of claim 1, wherein the tapered insertion tip configured to seal to a cervix that is dilated less than 3 cm.

11. The device of claim 1, wherein the tapered insertion tip is radially tapered from a larger diameter at a proximal portion of the tapered insertion tip to a smaller diameter at a distal portion of the tapered insertion tip.

12. The device of claim 1, wherein the mesh tube comprises a tubular core surrounded by a tubular sheath, wherein at least the tubular sheath comprises braided fibers.

13. The device of claim 12, wherein the tubular sheath and the tubular core each comprise braided fibers, wherein the tubular sheath and the tubular core have one or more of the following differences: different fiber diameters, different braid densities, different pick counts, and different fiber shapes.

14. The device of claim 12, wherein the tubular sheath has a smoother outer surface than the tubular core.

15. The device of claim 1, wherein the tapered insertion tip is coupled to a proximal cannula, wherein the insertion tip and the proximal cannula are separable from first elongate member, wherein the proximal cannula is configured to fit over the first elongate member when the mesh tube is extended through the opening of the insertion tip.

16. The device of claim 1, wherein the second elongate member comprises a distal cap that is distal to the mesh tube, wherein the distal cap is configured to at least partially cover the suction opening when the mesh tube is in the retracted configuration.

17. The device of claim 1, wherein the second elongate member is a rod.

18. The device of claim 1, further comprising a proximal handle coupled to the first elongate member having a suction port in fluid communication with the suction lumen.

19. The device of claim 18, further comprising a second handle portion coupled to the second elongate member and a seal between the proximal handle and the second elongate member configured to maintain suction through the suction lumen as the second elongate member is moved laterally within the suction lumen.

20. A medical drain device, the device comprising: a first elongate member having a suction lumen; a second elongate member that is movably disposed in the suction lumen of the first elongate member; an insertion tip coupled to a distal end of the first elongate member, the insertion tip having a tapered outer surface configured for atraumatic entry into a cervix that is dilated less than 3 cm by tapering to a diameter that is less than 3 cm; a suction opening on the insertion tip that is in fluid communication with the suction lumen; and a mesh tube that is coupled to the second elongate member, wherein the mesh tube is configured to transition between an extended configuration, in which the mesh tube is extended distally past the opening of the insertion tip, and a retracted configuration in which the mesh tube is retracted proximally into the suction lumen of the first elongate member by moving the second elongate member relative to the first elongate member, further wherein the mesh tube in the extended configuration is configured to provide a plurality of flow paths for fluid to flow to the suction opening when suction is applied from the suction opening.

21. A medical drain device, the device comprising: a first elongate member having a suction lumen; a second elongate member that is movably disposed in the suction lumen of the first elongate member; an insertion tip coupled to a distal end of the first elongate member, the insertion tip having a tapered outer surface configured for atraumatic entry into a cervix that is dilated less than 3 cm; a suction opening on the insertion tip that is in fluid communication with the suction lumen; and a mesh tube that is coupled to the second elongate member at a proximal end region and at a distal end region, wherein the mesh tube is configured to transition between an extended configuration, in which the mesh tube is extended distally past the opening of the insertion tip, and a retracted configuration in which the mesh tube is retracted proximally into the suction lumen of the first elongate member by moving the second elongate member relative to the first elongate member, further wherein the mesh tube in the extended configuration is configured to provide a plurality of flow paths for fluid to flow to the suction opening when suction is applied from the suction opening.

22. A method, the method comprising: inserting a tapered insertion tip at a distal end of a first elongate member of a medical drain device through an orifice of a cavity in a body, wherein the orifice has an open diameter that is less than a diameter of the tapered insertion tip; extending a mesh tube distally out of a suction opening on the tapered insertion tip and into the cavity by distally advancing a second elongate member to which the mesh tube is attached, wherein the second elongate member is movably disposed within a suction lumen of the first elongate member; and applying suction from the suction lumen through the suction opening so that fluid from the cavity passes through a plurality of flow paths formed by the mesh tube and into the suction lumen.

23. The method of claim 22, wherein extending the mesh tube distally out of the suction opening comprises unrolling and inverting the mesh tube by advancing the second elongate member to which a first end of the mesh tube is coupled, while a second end of the mesh tube is coupled to the first elongate member.

24. The method of claim 22, wherein extending the mesh tube distally out of the suction opening comprises advancing the second elongate member distally out of the suction opening.

25. The method of claim 22, wherein extending the mesh tube distally out of the suction opening comprises advancing the second elongate member distally out of the suction opening, wherein a first end of the mesh tube is coupled to a distal region of the second elongate member and a second end of the mesh tube is coupled to a proximal region of the second elongate member.

26. The method of claim 22, wherein inserting the tapered insertion tip comprises inserting the tapered insertion tip until the suction opening is within the cavity.

27. The method of claim 22, wherein extending the mesh tube distally out of the suction opening comprises deflecting a deflectable distal region of the tapered insertion tip so that the mesh tube can extend distally out of the suction opening.

28. The method of claim 27, wherein deflecting the deflectable distal region comprises deflecting a plurality of deflectable distal regions.

29. The method of claim 22, wherein extending the mesh tube distally out of the suction opening comprises extending a distal cap proximal to the mesh tube distally out of the suction opening.

30. The method of claim 22, wherein the tapered insertion tip has a larger outer diameter than an outer diameter of the first elongate member.

31. The method of claim 22, wherein extending the mesh tube distally out of the suction opening comprises extending the mesh tube through a channel in the tapered insertion tip to guide the mesh tube along a path through the insertion tip that is not parallel to a long axis of the insertion tip.

32. The method of claim 22, further comprising maintaining the application of suction to reduce hemorrhaging.

33. The method of claim 22, wherein inserting the tapered insertion tip comprises inserting the tapered insertion tip through a cervix that is dilated less than 3 cm and into a postpartum uterus.

34. The method of claim 22, wherein extending the mesh tube comprises extending a tubular core surrounded by a tubular sheath, wherein at least the tubular sheath comprises braided fibers.

35. The method of claim 34, wherein the tubular sheath and the tubular core each comprise braided fibers, wherein the tubular sheath and the tubular core have one or more of the following differences: different fiber diameters, different braid densities, different pick counts, and different fiber shapes.

36. The method of claim 34, wherein the tubular sheath has a smoother outer surface than the tubular core.

37. The method of claim 22, further comprising removing a blood clot from the mesh tube by pulling the mesh tube at least partially proximally back into the suction lumen to remove the blood clot off of the mesh tube, and extending the mesh tube distally back into the body cavity.

38. A method, the method comprising: inserting a tapered insertion tip at a distal end of a first elongate member of a medical drain device through an orifice of a cervix, wherein the cervix is dilated to less than 3 cm; extending a mesh tube distally out of a suction opening on the tapered insertion tip and into a postpartum uterus by distally advancing a second elongate member to which the mesh tube is attached, wherein the second elongate member is movably disposed within a suction lumen of the first elongate member; and applying suction from the suction lumen through the suction opening so that fluid from the uterus passes through a plurality of flow paths formed by the mesh tube and into the suction lumen.