Surgical drainage apparatus and use method thereof

Abstract

Surgical drainage devices are described herein that include a distal porous drainage region having two or more adjacent porous layers through which negative pressure can be applied to provide uniform negative pressure within the body region being treated. The distal porous drainage device may be configured to conform to the shape of a body region being treated.

Description

[0001] Priority Claim

[0002] This patent application claims priority to U.S. Provisional Patent Application No. 63 / 424,944, filed on November 13, 2022, and titled "SURGICAL DRAINS AND METHODS FOR USE", which is hereby incorporated by reference in its entirety.

[0003] Incorporation by Reference

[0004] All publications and patent applications mentioned in this specification are hereby 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.

[0005] Background

[0006] Surgical drains are implants that allow the removal of fluids (blood, pus, etc.) and / or gases from wounds or body cavities. This broadly includes nasogastric tubes, urinary catheters, vascular access ports, ventriculoperitoneal shunts, and negative pressure surgical drains. Negative pressure surgical drains are a newer type of active surgical drain that is thought to offer advantages not achieved by other types of surgical drains.

[0007] Generally, surgical drains can assist the healing process by removing inflammatory mediators, bacteria, foreign bodies, and necrotic tissue. Drains can relieve pressure that may impair perfusion or cause pain, thereby reducing morbidity and inflammation; they can monitor potential complications by allowing easy sampling of fluids during healing; and they can be used to address complications related to dead space. Active drains use intermittent or continuous negative pressure to draw fluids or gases from wounds or body cavities. Typically, passive drains are open systems, while active drains are closed systems because active drains rely on the negative pressure created by the drain.

[0008] Unfortunately, negative pressure drains often have difficulty providing uniform negative pressure within tissue cavities (both natural and those formed due to trauma), because soft tissue may self-collapse around the location where pressure is applied, isolating other areas from the pressure source. Additionally, it may be difficult to remove the drain from tissue, particularly damaged and healing tissue, without causing further injury and disrupting new healing.

[0009] A negative pressure drainage device may be particularly helpful in treating postpartum uterine hemorrhage. Postpartum uterine hemorrhage occurs when the uterine muscles fail to achieve sufficient contraction after childbirth to cut off the blood flow that previously circulated in the uteroplacental space. This lack of contraction is called atony (lack of tone). The uterine muscles normally cut off the blood flow through muscular contractions that effectively squeeze the arterial blood vessels passing through the tissue. In some cases, atony can lead to continued bleeding from the arterial blood vessels into the uterus (i.e., postpartum uterine hemorrhage). Postpartum hemorrhage, or excessive blood loss from the uterus after birth, is the leading cause of maternal death worldwide. Women who cannot control postpartum hemorrhage may require multiple blood transfusions and, in severe cases, a hysterectomy. Therefore, there is a desire to control this postpartum hemorrhage. Current medical devices and surgical procedures have proven insufficient to reduce postpartum hemorrhage or blood loss and / or are highly invasive.

[0010] What is needed is simply a negative pressure drainage device that can create and maintain a uniform negative pressure zone within soft tissue, including but not limited to the uterus, wounds, and body cavities, without disrupting tissue attachments and associated healing within the soft tissue.

[0011] Overview of the Present Disclosure

[0012] The surgical drainage devices and methods described herein provide negative pressure drainage that can create and maintain a uniform negative pressure zone within soft tissue. These devices (apparatuses, systems, drainers, etc.) can include one or more elongate members (e.g., tubes, catheters, and / or rods) coupled to a distal porous drainer (e.g., a mesh). The device can be configured to apply suction through the elongate member and the distal porous drainer. The distal porous drainer can be compliant and can distribute negative pressure (suction) within the soft tissue region being treated. The distal porous drainer can include two or more layers through which suction can be applied to provide multiple flow paths along the length of the distal porous drainer, e.g., into and between two or more porous layers. When positioned within a soft tissue region (e.g., a body cavity) under negative pressure, the distal porous drainer can conform to the tissue as it is pulled together while still maintaining a shape that allows fluid to flow through the pores of the distal porous drainer along its length (e.g., between the layers) and out of the soft tissue region. The device can include one or more integral or separate seals (e.g., plugs) that can help to enclose the soft tissue region such that negative pressure can be maintained.

[0013] These devices can be used for any suitable tissue, particularly soft tissue injuries where drainage and proper alignment of the tissue are needed or where negative pressure is required. In particular, these devices and methods of using them can be used to contract the uterus to reduce bleeding after childbirth.

[0014] The distal porous drain may be a mesh or other distal porous drain including a network of fluidly connected pores. The pore network is in communication with a vacuum source via one or more fluid paths, such as via one or more lumens of one or more elongate bodies coupled to the distal porous drain. The distal porous drain may be expanded within a body region to be treated (e.g., the uterus) and is configured to distribute negative pressure (suction) from the vacuum source within the body region to be treated. For example, negative pressure may be applied through the pores of the distal porous drain to cause fluid to flow within the pores and out of the body region. This may help remove inflammatory mediators, bacteria, foreign bodies, and / or necrotic tissue, thereby promoting soft tissue healing. Alternatively or additionally, the negative pressure may cause at least partial contraction of the soft tissue wall surrounding the body cavity, which may reduce bleeding.

[0015] The distal porous drain may receive suction from one or more openings at the distal end region of the elongate member and / or from one or more openings at the distal end region of another elongate member of the device (e.g., a second elongate member). Because the distal porous drain includes pores configured to allow easy passage of liquids, materials, and / or gases, the distal porous drain may help distribute the force of the negative pressure within a body region (e.g., a body cavity, such as the uterus). The distal porous drain may prevent local regions from having a higher negative pressure that could otherwise occlude portions of the body region, thereby impeding uniform drainage.

[0016] The distal porous drain may be in communication with an internal drain (e.g., a vacuum port coupled to a vacuum channel) such that negative pressure is applied to the exterior of the distal porous drain. This may allow the distal porous drain to distribute the negative pressure over a larger area and / or create a larger surface area for fluid control. The porosity of the distal porous drain (e.g., in a variant where the distal porous drain is formed of knitted, woven, or braided fibers, the space between the filaments) may be controllable.

[0017] For example, described herein is a surgical drainage device including: an elongate shaft having a suction lumen extending therethrough; a distal porous drain extending distally from the distal end region of the elongate shaft, wherein the distal porous drain includes two or more layers of porous material surrounding a central lumen that is in fluid communication with the suction lumen; and a compressible and self-expanding plug assembly on the outer surface of the elongate shaft.

[0018] The layer of porous material may include a mesh, such as a knitted, woven, or braided material. The layer of porous material may include an everted mesh tube having a first end connected to the elongate shaft at either end. In some instances, the layer of porous material includes a non-woven porous material sheet.

[0019] The distal porous drain may be tubular and may have two or more concentric cylindrical mesh walls. In any of these examples, the central lumen may be closed at the distal end region of the distal porous drain. The distal porous drain may have a non-tubular structure. For example, the distal porous drain may be formed as a pouch (flat) or a cone (e.g., flared) structure.

[0020] The plug may include an elastic body, an expandable mesh configured to radially compress the elastic body, and a fluid barrier membrane. In some examples, the plug includes one or more locks configured to lock the plug in a radially expanded configuration, a radially compressed configuration, or both a radially expanded configuration and a radially compressed configuration.

[0021] The distal porous drain may be configured to be compressed along its distal-to-proximal length without impeding the ability of the distal porous drain to remove material (e.g., fluid), which is achieved by maintaining multiple flow paths through and along multiple (two or more) porous material layers.

[0022] Any of these devices may include a suction port at the proximal end region of the device. In some examples, these devices include a suction connector having a suction port at the proximal end and a releasable connector at the distal end, where the releasable connector is configured to couple to a elongate shaft.

[0023] The compressible and self-expanding plug assembly may include viscoelastic foam. The plug assembly may be self-expanding and manually compressible. The plug may be configured to expand relatively slowly (e.g., over the course of tens of seconds or minutes), which may allow a user (physician, doctor, nurse, technician) to position or reposition the device.

[0024] Generally, these devices may be configured for draining a relatively large area. For example, the diameter of the distal porous drain in a relaxed state may be greater than 2 cm (e.g., 2 cm or greater, 3 cm or greater, 4 cm or greater, 5 cm or greater, 6 cm or greater, 7 cm or greater, 8 cm or greater, 9 cm or greater, 10 cm or greater, etc.).

[0025] For example, described herein is a surgical drainage device, comprising: an elongate shaft having a suction lumen extending therethrough; a distal porous drain extending distally from the distal end region of the elongate shaft, wherein the distal porous drain includes two or more adjacent mesh layers surrounding a central lumen, the central lumen being in fluid communication with the suction lumen; and a compressible and self-expanding plug assembly on the outer surface of the elongate shaft.

[0026] In some examples, a surgical drainage device includes: an elongate shaft having a suction lumen extending therethrough; a distal porous drain extending distally from a distal end region of the elongate shaft, wherein the distal porous drain includes a mesh tube that is flipped upon itself to form adjacent cylindrical layers around a central lumen that is in fluid communication with the suction lumen; and a compressible and self-expanding plug assembly on an outer surface of the elongate shaft.

[0027] Also described herein is a method of using any of these devices as a surgical drain. For example, a method of draining a body region can include: positioning a distal porous drain into the body region, wherein the distal porous drain extends distally from an elongate member formed with a suction lumen therethrough, and further wherein the distal porous drain includes two or more porous material layers around a central lumen that is in fluid communication with the suction lumen; forming a seal around the elongate member to maintain a vacuum within the body region; and applying a negative pressure through the suction lumen such that a plurality of flow paths are formed through and between the two or more porous material layers along the length of the distal porous drain.

[0028] The two or more porous material layers can include a mesh material. The two or more porous material layers can be attached to the (same) elongate member.

[0029] Any of these methods can include maintaining suction when the distal porous drain is compressed by the body region. Any of these methods can include maintaining a negative pressure within the body region after withdrawing the distal porous drain from the body region.

[0030] In any of these methods, forming the seal can include expanding a plug assembly coupled to the elongate member into a body passage leading to the body region. The plug can be disposed around an outer surface of a first elongate member. Any of these methods can include locking the plug in a radially expanded configuration to maintain the seal. Any of these methods can include radially compressing the plug before positioning the plug within the body passage. For example, radially compressing the plug can include pulling proximally on a compression layer covering an elastic body such that the compression layer elongates and applies a radially compressive force on the elastic body.

[0031] Any of these methods can include connecting the suction lumen of the device to a suction source before applying the negative pressure. The method can include, wherein connecting the suction lumen includes releasably coupling the elongate member to a suction connector having a friction fit connector for the elongate member and a suction port configured to couple to a negative pressure source.

[0032] The present disclosure also describes a surgical drainage device that includes a plug assembly configured to be easy to use and effectively seal. For example, the surgical drainage device can include: an elongate member having a suction lumen extending therethrough; a distal porous drain that extends distally from a distal end region of the elongate shaft, where the distal porous drain includes two or more porous material layers surrounding a central lumen that is in fluid communication with the suction lumen; and a compressible and self-expanding plug assembly on an outer surface of the elongate outer shaft; and a plug assembly positioned around an outer surface of the first elongate member, the plug assembly including an elastic body covered by a covering, where the covering is arranged to apply a radial compressive force on the elastic body to radially compress the elastic body and release the compressive force to allow the elastic body to resume a radially expanded state.

[0033] The covering can include a compression layer and a fluid barrier layer, the compression layer being configured to apply the compressive force. In some examples, the compression layer includes an expandable mesh. The covering can be coupled to a slidable proximal connector configured to elongate the covering when driven distally, thereby creating a radial compressive force. The slidable proximal connector can be configured to apply an axial compressive force on the elastic body when driven distally, thereby enhancing the elastic body in a radially expanded state. The plug assembly can include a plurality of elastic bodies configured to axially slide relative to the first elongate member, where the slidable proximal connector is configured to compress the plurality of elastic bodies together when driven distally. The plug assembly can include an actuator configured to activate the slidable proximal connector. The slidable proximal connector can be configured to be actuated by hand.

[0034] In some examples, the resilient body has flat sides that, when the resilient body is in a radially expanded state, are oriented at a predetermined angle relative to the outer surface of the first elongated member. The predetermined angle can be approximately 90 degrees. When a radially compressive force is applied to the resilient body, the resilient body can be configured to fold radially inward. The covering can be configured to twist relative to the first elongated member. The covering can be coupled to a slidable proximal connector that is configured to rotate relative to the first elongated member when driven proximally, thereby twisting the covering. The resilient body can be positioned at the distal end of the first elongated member, where the distal porous drain is configured to extend distally away from the first elongated member through the distal end of the first elongated member. In some examples, the resilient body includes foam. The plug assembly can include one or more locks that are configured to lock the resilient body in a radially expanded state. The one or more locks can be further configured to lock the resilient body in a radially compressed state. When in the radially expanded state, the resilient body can have a circular radial cross-section. When in the radially expanded state, the resilient body can have an elliptical radial cross-section. When in the radially expanded state, the resilient body can have a rectangular axial cross-section. In some examples, when in the radially expanded state, the resilient body has a circular axial cross-section. When in the radially expanded state, the resilient body can have an elliptical axial cross-section.

[0035] A method of draining a body region can include: positioning a distal porous drain into the body region, where the distal porous drain extends distally from an elongated member, the distal porous drain being formed with a suction lumen therethrough, and further, where the distal porous drain includes two or more porous material layers surrounding a central lumen that is in fluid communication with the suction lumen; positioning a plug disposed around a first elongated member into a body passage leading to the body region, where the plug includes a resilient body covered by a covering, where, during positioning of the plug, the plug is in a radially compressed state, where the covering applies a radially compressive force on the resilient body; forming a seal to maintain a vacuum within the body region by expanding the plug within the body passage, where expanding the plug includes releasing the radially compressive force applied by the covering on the resilient body; and applying a negative pressure through the suction lumen such that multiple flow paths are created through and between the two or more porous material layers along the length of the distal porous drain.

[0036] In some examples described herein, a surgical drainage device includes: a first elongated member having a lumen; a second elongated member slidably disposed within the lumen of the first elongated member; a distal porous drain having a proximal end coupled to the distal end region of the second elongated member and a distal end extending freely from the second elongated member, the distal porous drain including a network of interconnected pores; and a vacuum channel extending proximally from the distal porous drain and in fluid communication with the network of interconnected pores.

[0037] The distal porous drain can be a tube having a porous wall. The porous wall can terminate at the distal end of the distal porous drain. The distal porous drain can be a non-tubular structure. The device can also include a plug disposed about the first elongated member, wherein the plug is configured to expand radially outward to seal against soft tissue, thereby fluidly isolating the distal porous drain within a soft tissue cavity. The plug can include an elastic body, an expandable mesh configured to radially compress the elastic body, and a fluid barrier membrane. The plug can include one or more locks configured to lock the plug in a radially expanded configuration, a radially compressed configuration, or both a radially expanded configuration and a radially compressed configuration. The distal porous drain can be configured to allow fluid to flow through the network of interconnected pores and out of the body cavity via the vacuum channel. The vacuum channel can be within the lumen of the first elongated member, within a second lumen of the second elongated member, or within the lumen of the first elongated member and within a second lumen of the second elongated member. The vacuum channel can be operatively coupled to a port at the proximal end region of the device. The device can also include one or more seals between the first elongated member and the second elongated member. The device can also include one or more locks configured to lock the relative positions of the first elongated member and the second elongated member.

[0038] A method of draining a body region is also described herein, the method including: positioning a distal porous drain into the body region, wherein the distal porous drain has a proximal end coupled to the distal end region of a second elongated member and a distal end extending freely from the second elongated member, the distal porous drain including a network of interconnected pores, wherein positioning the distal porous drain includes advancing the second elongated member distally within the lumen of a first elongated member; forming a seal to maintain a vacuum within the body region; and applying a negative pressure within the body region by applying suction in a proximal direction via the network of interconnected pores.

[0039] The distal porous drain may be a tube having a porous wall. The porous wall may terminate at the distal end of the distal porous drain. The distal porous drain may be a non-tubular structure. The method may further include retracting the second elongate member proximally to draw the distal porous drain into the lumen of the first elongate member. The method may further include maintaining a negative pressure within the body region after withdrawing the distal porous drain from the body region. Positioning the distal porous drain into the body region may cause the distal porous drain to expand. Forming the seal may include expanding a plug into a body passage leading to the body region. The plug may be disposed about the first elongate member. The method may further include locking the plug in a radially expanded configuration to maintain the seal. The method may further include radially compressing the plug before positioning the plug within the body passage. Radially compressing the plug may include pulling proximally on a compression layer covering an elastic body such that the compression layer elongates and applies a radially compressive force on the elastic body. The method may further include locking the plug in a radially compressed state.

[0040] Any device may include one elongate member or multiple elongate members (e.g., 2, 3, 4, 5 or more elongate members). In some cases, the elongate members may be nested (e.g., concentrically arranged) and translatable relative to each other (e.g., slidable). For example, the distal porous drain and / or the plug may be coupled to a first (e.g., inner) elongate member that may be slidably disposed within the lumen of a second (e.g., outer) elongate member. The first elongate member may be pushed distally relative to the second elongate member (or the second elongate member may be pulled proximally relative to the first elongate member) to advance and / or expand the distal porous drain and / or the plug. Similarly, the first elongate member may be pulled proximally relative to the second elongate member (or the second elongate member may be pushed distally relative to the first elongate member) to retract and / or collapse the distal porous drain and / or the plug. Such pulling and pushing may be actuated by manually gripping the first elongate member and / or the second elongate member and sliding the first elongate member and / or the second elongate member relative to each other, or may be actuated by one or more actuators on a handle of the device.

[0041] In some examples, the elongate member includes a flexible and / or curved tube. For example, the elongate member can have a polymeric shaft that can be bent or curved to allow it to travel through a bend within an anatomical structure. In some examples, the elongate member is pre-bent or pre-kinked at one or more regions along its length. In some examples, the elongate member is steerable over all or part of its length. For example, the elongate member can include one or more tendons to allow steering. The elongate member can have any suitable length. For example, the elongate member can be between about 10 and 100 cm (e.g., between about 15 and 80 cm, between about 20 and about 50 cm, etc.). The elongate member can be formed from a polymeric material and / or a metallic material.

[0042] Any of the distal porous drainers described herein can include a mesh that is a knitted, woven, or braided material. In some examples, the distal porous drainer is a non-woven material (e.g., a sheet or layer such as a polymeric material) having apertures of sufficient size therethrough to allow fluid and biologic debris (e.g., pus, clots, etc.) to pass therethrough without significant resistance. In some examples, the distal porous drainer is a fabric. The distal porous drainer can be formed from multiple filaments of material (e.g., strands), such as monofilaments or multiple filaments. For example, the distal porous drainer can include a braided polymeric monofilament having 24 strands or more (e.g., 30 strands or more, 34 strands or more, 36 strands or more, 38 strands or more, 40 strands or more, 42 strands or more, etc.).

[0043] As described above, the distal porous drainer can expand into an expanded configuration. In some examples, the distal porous drainer is biased to expand into an expanded configuration. For example, the distal porous drainer can be formed from a shape memory material (e.g., nitinol, etc.) that can be shape-set to an expanded configuration in which the distal porous drainer expands away from the second elongate member and / or the first elongate member.

[0044] In some examples, the distal porous drain has a tubular shape and the device is configured to invert the tubular distal porous drain. One end of the invertible tubular distal porous drain can be connected to a first elongate member (e.g., a tube), and the opposite end of the invertible tubular porous drain can be connected to a second elongate member (e.g., an inner tube or rod). The second elongate member can be sized and shaped to fit within the lumen of the first elongate member. The invertible tubular distal porous drain can be extended within the body region by pushing the second elongate member. In some cases, when the tubular distal porous drain is extended into the body region, the second elongate member is positioned within the first elongate member, which can cause the tubular distal porous drain to assume a double-walled tubular shape. The invertible tubular distal porous drain can be removed from the body region by pulling the second elongate member such that the tubular distal porous drain is inverted and fully withdrawn back into the first elongate member.

[0045] For example, a surgical drainage device is described herein that includes: a first elongate member having a lumen; a second elongate member slidably disposed within the lumen; an invertible tubular distal porous drain having a first end coupled to the distal end region of the first elongate member at a first end and a second end coupled to the distal end region of the second elongate member, the invertible tubular distal porous drain including a network of interconnected pores, wherein the invertible tubular distal porous drain has an expanded configuration in which the invertible tubular distal porous drain has a double-walled tubular configuration and the second elongate member is fully withdrawn distally within the lumen of the first elongate member, and wherein the invertible tubular distal porous drain has a retracted configuration in which the invertible tubular distal porous drain is inverted and withdrawn into the lumen of the first elongate member; and a vacuum channel extending proximally from the invertible tubular distal porous drain and in fluid communication with the network of interconnected pores.

[0046] The axial position of the first elongate member can be configured to lock relative to the second elongate member to lock the reversible tubular distal porous drain in a double-wall tubular shape in the case where the second elongate member is fully withdrawn distally within the lumen of the first elongate member. The axial position of the first elongate member can be configured to lock relative to the second elongate member to lock the reversible tubular distal porous drain in a retracted configuration. The device can also include a plug disposed about the first elongate member, wherein the plug is configured to expand radially outward to seal against soft tissue, thereby fluidly isolating the distal porous drain within the soft tissue cavity. The plug can include an elastomeric body, an expandable mesh configured to radially compress the elastomeric body, and a fluid barrier membrane. The plug includes one or more locks configured to lock the plug in a radially expanded configuration, a radially compressed configuration, or both a radially expanded configuration and a radially compressed configuration. The expandable mesh and the fluid barrier membrane can be coupled to a slidable proximal connector configured to elongate the expandable mesh when driven proximally, thereby creating a radially compressive force on the elastomeric body. The slidable proximal connector can be configured to apply an axial compressive force on the elastomeric body when driven distally, thereby enhancing the elongate body in the radially expanded state. The plug assembly can include a plurality of elastomeric bodies configured to axially slide relative to the first elongate member, wherein the slidable proximal connector is configured to compress the plurality of elastomeric bodies together when driven distally.

[0047] Also described herein is a method of draining a body region, the method comprising: positioning a reversible tubular distal porous drain including a network of interconnected pores into the body region, the reversible tubular distal porous drain having a first end coupled to the distal end region of a first elongate member and a second end coupled to the distal end region of a second elongate member, wherein the reversible tubular distal porous drain is in a double-wall tubular configuration and the second elongate member is fully withdrawn distally within the lumen of the first elongate member when the reversible tubular distal porous drain is positioned within the body region; forming a seal to maintain a vacuum within the body region; and applying a negative pressure within the body region by applying suction in a proximal direction through the network of interconnected pores.

[0048] Positioning the flip - able tubular distal multi - porous drain into a body region can include: advancing distally a second elongate member to extend a second end of the flip - able tubular distal multi - porous drain into the body region; and retracting the second elongate member such that a distal end region of the second elongate member is retracted into the lumen of the first elongate member, wherein the flip - able tubular distal multi - porous drain folds to form a double - walled tubular configuration. Positioning the flip - able tubular distal multi - porous drain into the body region can cause the flip - able tubular distal multi - porous drain to bend laterally upon contact with a tissue wall. The double - walled tubular configuration can define a central lumen in the flip - able tubular distal multi - porous drain, wherein applying suction in the proximal direction causes fluid to flow from the body region into the central lumen of the flip - able tubular distal multi - porous drain. The distal end of the second elongate member can be axially positioned near the distal end of the first elongate member to maximize the length of the flip - able tubular distal multi - porous drain extending distally from the first elongate member in the double - walled tubular configuration. Applying negative pressure can include applying suction from the distal end of the first elongate member, from one or more openings of the second elongate member, or from the distal end of the first elongate member and one or more openings of the second elongate member. Forming a seal can include expanding a plug that is disposed around the first elongate member within a body passage leading to the body region. The plug can include an elastic body covered by a covering, wherein the plug is in a radially compressed state in which, during positioning of the plug within the body passage, the covering applies a radially compressive force on the elastic body, and wherein expanding the plug includes releasing the radially compressive force applied by the covering on the elastic body. The method can further include retracting proximally the second elongate member to flip the flip - able distal multi - porous drain when the flip - able tubular distal multi - porous drain is being pulled into the lumen of the first elongate member. The method can further include maintaining negative pressure in the body region for a period of time after pulling the flip - able tubular distal multi - porous drain into the lumen of the first elongate member

[0049] The second elongate member can be formed as a solid member (e.g., a rod, bar, wire, etc.) or the second elongate member can be hollow (e.g., a catheter, tube, etc.). The second elongate member can be a polymeric material and / or a metallic material, such as stainless steel, nitinol, etc. The second elongate member can be flexible and / or bent (e.g., pre-bent or pre-curved) along all or a portion of its length. Since the second elongate member is slidably disposed within the first elongate member, the second elongate member generally has an outer diameter (OD) that is smaller than the inner diameter (ID) of the first elongate member. Movement of the second elongate member within the first elongate member can be restricted and / or can include one or more (e.g., a plurality of) "stop" positions that can releasably hold the relative positions of the second elongate member and the first elongate member. For example, a stop can be configured to hold the position of the second elongate member such that the second elongate member remains fully withdrawn within the first elongate member, and the retractable tubular distal porous drain has a double-wall configuration.

[0050] Any device can include one or more expandable / contractable plugs (also referred to as occluders) that are integral with or separate from other parts of the device (e.g., an elongate member) and are configured to engage with other parts of the device. The plug can form a seal between the device and the wall of a body region (e.g., a duct, passage, or incision) such that the distal porous drain can be sealed within the treated body cavity and such that negative pressure can be applied to drain the body cavity and / or collapse the body cavity. The plug can be radially expandable and contractable such that it can be inserted into the body region in a contracted state and expanded within the body region to occlude and seal the entrance to the body cavity. In some examples, the plug can include a compressible porous material covered by a membrane or sheath (e.g., a deformable layer) that can help form a seal against body tissue. In some examples, the occluder can include one or more sacs. The plug can have a channel or lumen that allows other components of the device to operate through the plug without breaking the seal. In some examples, the plug can surround an outer portion of the elongate member such that suction can be applied through the lumen of the elongate member.

[0051] For example, this document describes a surgical drainage device, comprising: a first elongated member having a lumen; a second elongated member slidably disposed within the lumen of the first elongated member; a distal porous drain having a proximal end coupled to the distal end region of the second elongated member, the distal porous drain including a network of interconnected pores; a vacuum channel extending proximally from the distal porous drain and in fluid communication with the network of interconnected pores; and a plug assembly positioned around the outer surface of the first elongated member, the plug assembly including an elastomeric body covered by a covering, wherein the covering is arranged to apply a radial compressive force on the elastomeric body to radially compress the elastomeric body and release the compressive force to allow the elastomeric body to resume a radially expanded state.

[0052] The covering may include a compression layer and a fluid barrier layer, the compression layer being configured to apply the compressive force. The compression layer may include an expandable mesh. The covering may be coupled to a slidable proximal connector configured to elongate the covering when driven distally, thereby generating a radial compressive force. The slidable proximal connector may be configured to apply an axial compressive force on the elastomeric body when driven distally, thereby enhancing the elastomeric body in the radially expanded state. The plug assembly may include a plurality of elastomeric bodies configured to axially slide relative to the first elongated member, wherein the slidable proximal connector is configured to compress the plurality of elastomeric bodies together when driven distally. The plug assembly may include an actuator configured to activate the slidable proximal connector. The slidable proximal connector may be configured to be actuated by hand. When the elastomeric body is in the radially expanded state, the elastomeric body may have a flat side surface oriented at a predetermined angle relative to the outer surface of the first elongated member. The predetermined angle may be approximately 90 degrees. When a radial compressive force is applied on the elastomeric body, the elastomeric body may be configured to radially fold inwardly. The covering may be configured to twist relative to the first elongated member. The covering may be coupled to a slidable proximal connector configured to rotate relative to the first elongated member when driven proximally, thereby twisting the covering. The elastomeric body may be positioned at the distal end of the first elongated member, wherein the distal porous drain is configured to extend distally away from the first elongated member through the distal end of the first elongated member. The elastomeric body may include a foam or a sponge. The plug assembly may include one or more locks configured to lock the elastomeric body in the radially expanded state. The one or more locks may be further configured to lock the elastomeric body in the radially compressed state. When in the radially expanded state, the elastomeric body may have a circular radial cross-section. When in the radially expanded state, the elastomeric body may have an oval radial cross-section. When in the radially expanded state, the elastomeric body may have a rectangular axial cross-section. When in the radially expanded state, the elastomeric body may have a circular axial cross-section. When in the radially expanded state, the elastomeric body may have an oval axial cross-section.

[0053] The present disclosure also describes a method for draining a body region, the method comprising: positioning a distal porous drain into the body region by advancing a second elongate member coupled to the distal porous drain distally within the lumen of a first elongate member, the distal porous drain including a network of interconnected pores; positioning a plug disposed around the first elongate member into a body passage leading to the body region, the plug including an elastomeric body covered by a covering, wherein the plug is in a radially compressed state during positioning of the plug, and wherein the covering applies a radially compressive force on the elastomeric body; forming a seal by expanding the plug within the body passage to maintain a vacuum within the body region, wherein expanding the plug includes releasing the radially compressive force applied by the covering on the elastomeric body; and applying a negative pressure within the body region by applying suction in a proximal direction via the network of interconnected pores.

[0054] The covering may include a compression layer and a fluid barrier layer, the compression layer being configured to apply the compressive force. The compression layer may include an expandable mesh. The method further includes placing the plug in a radially compressed state by generating a radially compressive force on the elastomeric body by driving a slidable proximal connector in a proximal direction to elongate the covering. The radially compressive force may cause the elastomeric body to radially fold inwardly. Forming the seal may include enhancing the elastomeric body in a radially expanded state by driving the slidable proximal connector distally to apply an axial compressive force on the elastomeric body. The plug assembly may include a plurality of elastomeric bodies configured to axially slide relative to the first elongate member, wherein forming the seal includes driving the slidable proximal connector distally to compress the plurality of elastomeric bodies together. Driving the slidable proximal connector in a proximal direction may include activating an actuator. Driving the slidable proximal connector in a proximal direction may include pulling a handle by hand. When the elastomeric body is in a radially expanded state, the elastomeric body may have a flat side oriented at a predetermined angle relative to the outer surface of the first elongate member. The predetermined angle may be approximately 90 degrees. Releasing the radially compressive force applied on the elastomeric body may include untwisting the configured covering. The elastomeric body may be positioned at the distal end of the first elongate member, wherein advancing the second elongate member causes the distal porous drain to exit the first elongate member through the distal end of the first elongate member. The elastomeric body may include foam or sponge. Forming the seal includes locking the plug in a radially expanded state. The method may further include locking the plug in a radially compressed state.

[0055] In some examples, the device can be configured to operate passively. For example, the distal porous drainer and / or plug can be configured to expand passively when placed within a body region and collapse passively (e.g., without activation) when removed from the body region. In other examples, the distal porous drainer and / or plug can expand and / or collapse upon activation of one or more actuators. The actuators can be located on a region of the device that is external to the body cavity, such as on one or more handles of the device. The actuators can be actuated by sliding, pulling, pushing, and / or applying pressure (e.g., by a user's hand).

[0056] The distal porous drainer typically has pores that can be large enough to allow fluids and some solid biologic debris (e.g., clots, pus, coagulum) to pass through easily. For example, the pores can have a pore diameter of 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, 1 mm or greater, 1.1 mm or greater, 1.2 mm or greater, 1.3 mm or greater, 1.4 mm or greater, etc.). The pores can be formed by spaces between strands, such as in a knitted porous mesh that is woven, braided, and / or knitted. Any distal porous drainer can be self-expanding (e.g., formed from a material such as nitinol, nitinol mixed with a polymer, etc.).

[0057] Any of these devices can be coated with one or more materials to enhance their biologic efficacy. For example, the devices can be coated with clot-promoting materials such as aprotinin, tranexamic acid (TXA), ε-aminocaproic acid, and aminomethylbenzoic acid. For example, any distal porous drainer described herein can include a clot-promoting material.

[0058] Any device can include one or more seals located between the first elongate member and the second elongate member. The seals can be configured (e.g., shaped, positioned, formed from a suitable material, etc.) to allow the second elongate member to slide within the lumen of the first elongate member without requiring too much force to slide. For example, the seal can be an O-ring (or O-rings), which can be lubricated or non-lubricated.

[0059] As described above, the device (e.g., system) can be configured to maintain the relative positions of the first elongate member and the second elongate member. This can be achieved by a locking mechanism, such as a lock that is configured to fix (e.g., removably fix) the relative positions of the first elongate member and the second elongate member. The lock can allow the relative positions to be maintained until additional force is applied to overcome the holding force. For example, the lock can be a ratchet element at the proximal end of the device (e.g., on a handle or a portion of a handle at the proximal end).

[0060] The present disclosure also describes methods of removing substances (e.g., fluids) from a body region and / or contracting a body region using any of the devices described herein. These methods can be methods of evacuating a body region and / or contracting a body region. These methods can be methods of reducing bleeding. Any suitable body region can be treated as described. For example, the body region can be the uterus, and the method can be a method of contracting the uterus to reduce bleeding. The body region can be a wound, and the method can be a method of promoting healing by draining the wound and / or reducing bleeding and / or promoting healing. For example, these methods and devices can be used after breast surgery to treat (e.g., drain) chest wounds, hernias, etc.

[0061] In some instances, the distal porous drain expands within the body region. In any of the devices described herein, the distal porous drain can be soft and compliant when expanded, for example. Any of the methods can include conforming the distal porous drain within the body region being treated; this can include flattening the distal porous drain.

[0062] In any of the methods described herein, forming a seal can include expanding a plug located on the proximal region of the elongate member.

[0063] Applying negative pressure can include applying suction from the distal end of the elongate member. In some examples, applying negative pressure includes applying suction from one or more openings through the sidewall of the distal end region of the second elongate member.

[0064] Generally, these methods can include compressing the body region by distributing the force of the vacuum by applying negative pressure from the distal porous drain.

[0065] As described above, the flipable porous mesh can help distribute the force of the negative pressure. During the application of negative pressure (or in some cases, after a desired amount of negative pressure has been applied), the distal porous drain can be withdrawn, leaving a device that includes (in some examples) a plug that maintains the negative pressure.

[0066] The negative pressure within the body region can be maintained for any suitable length of time. For example, the negative pressure can be maintained for 1 minute or longer (e.g., 2 minutes or longer, 5 minutes or longer, 10 minutes or longer, 15 minutes or longer, 20 minutes or longer, 25 minutes or longer, 30 minutes or longer, 45 minutes or longer, 1 hour or longer, 1.5 hours or longer, 2 hours or longer, 3 hours or longer, 4 hours or longer, 5 hours or longer, 6 hours or longer, 7 hours or longer, 8 hours or longer, etc.).

[0067] In any of these methods, the distal end of the distal porous drain can be positioned within the tissue to be treated, such as within the uterus.

[0068] For example, this document describes a surgical drainage device, including: a first elongated shaft; a second elongated shaft having a suction lumen extending therethrough, wherein the second elongated shaft is configured to axially move within the first elongated shaft; a distal porous drainer extending distally from the distal end regions of the first and second elongated shafts, wherein the distal porous drainer includes two or more porous material layers surrounding a central lumen that is in fluid communication with the suction lumen; and a compressible and self-expanding plug assembly on the outer surface of the first elongated shaft.

[0069] The device according to claim 1, wherein the two or more porous material layers may include a mesh. In some instances, the two or more porous material layers may include knitted, woven, or braided materials. The two or more porous material layers may include a non-woven porous material sheet. The two or more porous material layers may include an everted mesh tube having a first end coupled to the first elongated shaft and a second end coupled to the second elongated shaft.

[0070] The distal porous drainer may be tubular and may have two or more concentric cylindrical mesh walls. The central lumen may be open at the distal end region of the distal porous drainer. The distal porous drainer may be a non-tubular structure.

[0071] The plug assembly may include an elastic body, an expandable mesh configured to radially compress the elastic body, and a fluid barrier membrane. The elastic body may be a foam material. For example, the compressible and self-expanding plug assembly may include a viscoelastic foam. Generally, the elastic body may be compressed and may self-expand back to its uncompressed configuration.

[0072] Any of these devices may include one or more locks configured to lock the plug assembly in a radially expanded configuration, a radially compressed configuration, or both a radially expanded configuration and a radially compressed configuration. The distal porous drainer may be configured to be compressed along its distal-to-proximal length. Any of these devices may include a suction port at the proximal end region of the device. Any of these devices may include a suction connector having a suction port at the proximal end and a releasable connector at the distal end, wherein the releasable connector is configured to couple to the first elongated shaft.

[0073] The diameter of the distal porous drainer in a relaxed state may be greater than 2 cm. In any of these devices, the distal porous drainer may be configured to extend out of or retract into the first elongated shaft when the second elongated shaft axially moves relative to the first elongated shaft. Any of these devices may include a stop (e.g., an edge, ridge, latch, pawl, etc.) that limits the axial movement of the second elongated shaft relative to the first elongated shaft to prevent the second elongated shaft from extending distally out of the first elongated shaft.

[0074] For example, a surgical drainage device may include: a first elongated shaft; a second elongated shaft having a suction lumen extending therethrough, wherein the second elongated shaft is configured to move coaxially relative to the first elongated shaft; a distal porous drainer including a flip tube having a first end coupled to a distal end region of the first elongated shaft and a second end coupled to a distal end region of the second elongated shaft such that the distal porous drainer includes two or more adjacent mesh layers surrounding a central lumen that is in fluid communication with the suction lumen; and a compressible and self-expanding plug assembly on an outer surface of the first elongated shaft.

[0075] In some examples, a surgical drainage device includes: a first elongated shaft; a second elongated shaft having a suction lumen extending therethrough; a distal porous drainer extending distally from distal end regions of the first and second elongated shafts, wherein the distal porous drainer includes a mesh tube that is flipped upon itself to form adjacent cylindrical layers surrounding a central lumen that is in fluid communication with the suction lumen; and a compressible and self-expanding plug assembly on an outer surface of the first elongated shaft.

[0076] As described above, methods of draining a body region are also described herein. For example, a method may include: positioning a distal porous drainer into a body region, wherein the distal porous drainer extends distally from a first elongated shaft and a second elongated shaft coaxial with the first elongated shaft, and further wherein the distal porous drainer includes two or more concentric layers of flexible porous material surrounding a central lumen that is in fluid communication with a suction lumen extending through the first elongated shaft; forming a seal around the first elongated shaft to maintain a vacuum within the body region; and applying a negative pressure through the suction lumen such that a plurality of flow paths are formed along the length of the distal porous drainer through and between the two or more concentric layers of porous material.

[0077] The two or more concentric layers of porous material may include a mesh material. The distal porous drainer may be attached to the first elongated shaft at a first end and to the second elongated shaft at a second end.

[0078] Any of these methods may include maintaining suction when the distal porous drainer is compressed by the body region.

[0079] In some instances, positioning the distal porous drainer in the body region may include advancing the second elongated shaft distally to extend the distal porous drainer distally out of the first elongated shaft and into the body region distally out of the second elongated shaft.

[0080] Any of these methods can include maintaining a negative pressure within the body region after withdrawing the distal porous drain from the body region. Forming the seal can include expanding a plug assembly coupled to a first elongate shaft into a body passage leading to the body region. The plug assembly can be disposed about an outer surface of the first elongate shaft. Any of these methods can include locking the plug assembly in a radially expanded configuration to maintain the seal. Any of these methods can include radially compressing the plug assembly prior to positioning the plug assembly within the body passage. Radially compressing the plug assembly can include pulling proximally on a compression layer covering an elastic body such that the compression layer elongates and applies a radially compressive force on the elastic body. Any of these methods can include connecting a suction lumen to a suction source prior to applying the negative pressure.

[0081] Connecting the suction lumen can include releasably coupling the first elongate shaft to a suction connector having a friction fit connector for the first elongate shaft and a suction port configured to couple to a negative pressure source.

[0082] All methods and apparatuses described herein (in any combination) are contemplated herein and can be used to achieve the benefits described herein. BRIEF DESCRIPTION OF THE DRAWINGS

[0083] 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, in conjunction with the accompanying drawings, in which:

[0084] Figures 1A to 1B An example of a surgical drainage device described herein is schematically illustrated, the surgical drainage device including a two-layer distal porous drain. Figure 1B A cross-sectional view taken through an example of Figure 1A is shown.

[0085] Figures 1C to 1F An exemplary device during treatment of a tissue region is shown. Figures 1A to 1B is shown. Figure 1C A cross-sectional top view of a body region is shown; and Figure 1D The body region is shown in a cross-sectional side view. Figure 1E From a view taken through the body region Figure 1C the same as Figures 1A to 1B the device of Figure 1C and Figure 1D is shown inserted into the body region of Figure 1F From a view taken through the body region Figure 1D the same as Figure 1E the device shown in Figures 1A to 1B is shown, showing compression of the flexible distal porous drain without vacuum locking.

[0086] Figures 2A to 2EA side view of an exemplary device with different tubular distal porous drainers is shown.

[0087] Figures 3A1 to 3E2 A distal end view and a side view of an exemplary device with a tubular distal porous drainer are shown.

[0088] Figures 4A1 to 4E2 A distal end view and a side view of an exemplary device with different distal porous drainers are shown.

[0089] Figures 5A1 to 5A4 An example of how a device with a tubular distal porous drainer can provide a fluid path for withdrawing fluid and / or gas is shown.

[0090] Figures 6A to 6C A partially transparent side view of an exemplary device including a flippable tubular distal porous drainer is shown.

[0091] Figures 7A to 7C An exemplary device with a plug and an exemplary use of the device in a soft tissue area of the body are shown.

[0092] Figure 8 An exemplary device with a plug assembly controlled by axial movement of a handle and a flippable tubular distal porous drainer is shown.

[0093] Figure 9 An exemplary plug assembly is shown, where the elastic body has a covering that is a compression mesh.

[0094] Figures 10A to 10B An exemplary plug assembly is shown where the outer surface of the elastic body is covered with a covering.

[0095] Figures 11A to 11C An exemplary plug assembly including a plurality of elastic bodies is shown.

[0096] Figures 12A to 12B An exemplary plug assembly configured to fold an elastic body to reduce its radial size is shown.

[0097] Figures 13A to 13B An exemplary plug assembly configured to compress an elastic body by twisting is shown.

[0098] Figures 14A to 14D An exemplary plug assembly is shown where the elastic body is axially positioned at the distal end of an elongate member.

[0099] Figure 15 Exemplary elastic bodies with different axial cross-sectional and radial cross-sectional shapes are shown.

[0100] Figures 16A to 16BShows an example of a flip - able tubular distal porous drain configured to assume a bent shape when extended from a elongate member.

[0101] Figures 17A to 17F Shows an exemplary device including a flip - able distal porous drain and a plug.

[0102] Figures 18A to 18B Shows an exemplary device having a flip - able distal porous drain and biased to assume a bent shape when expanded.

[0103] Figure 19 Is a flow chart of an exemplary method of treating a body region using the devices described herein.

[0104] Figures 20A to 20B Shows an example of a sealing connector (e.g., a sealing cap) for coupling any of the devices described herein to a suction source. Figure 20A Shows the sealing cap before attachment, and Figure 20B Shows the sealing cap after attachment.

[0105] Figures 21A to 21B Shows an example of a sealing connector (sealing cap) configured as a male sealing connector for coupling any of the devices described herein to a suction source. Figure 21A Shows the sealing cap before attachment, and Figure 21B Shows the sealing cap after attachment.

[0106] Figures 22A to 22B Shows an example of a sealing connector (sealing cap) configured as a female sealing connector for coupling any of the devices described herein to a suction source. Figure 22A Shows the sealing cap before attachment, and Figure 22B Shows the sealing cap after attachment.

[0107] Figures 23A to 23B Shows an example of a sealing connector (sealing cap) configured as a female sealing connector for coupling any of the devices described herein to a suction source. Figure 23A Shows the sealing cap before attachment, and Figure 23B Shows the sealing cap after attachment.

[0108] Figures 24A to 24F Shows a similar to Figures 22A to 22B and Figures 23A to 23B An example of the sealing connector (sealing cap) shown therein, which is coupled to a surgical drainage device described herein. Figure 24A Shows a perspective view of the sealing cap; Figure 24B Shows a side view of the sealing cap and the proximal end of the drainage device. Figure 24C Shows an end view of the sealing cap and the proximal end of the drainage device.Figure 24D Shows another perspective view of the sealing cap and the proximal end of the drainage device. Figure 24E Shows a transparent view, and Figure 24F Shows a cross-sectional view of the sealing cap and the proximal end of the drainage device.

[0109] Figures 25A to 25E Shows a similar to Figures 20A to 20B and Figures 21A to 21B An example of a sealing connector (sealing cap) as shown in, which is coupled to the surgical drainage device described herein. Figure 25A Shows a side view of the sealing cap and the proximal end of the drainage device. Figure 25B Shows an end view. Figure 25C Shows a partially transparent perspective view. Figure 25D Shows a perspective view of the sealing cap and the proximal end of the drainage device. Figure 25E Shows a cross-sectional view taken through the sealing cap and the proximal end of the drainage device.

[0110] Figures 26A to 26H Shows different examples of compressible / dilatable plugs (e.g., foam plugs) or partial plugs that can be included as part of any device described herein. Figures 25A to 26H The plug shown in can be part of a larger plug structure.

[0111] Figures 27A to 27G Shows an example of a surgical drainage device that includes a compressible / dilatable plug structure using multiple partial plugs such as those shown in Figures 26A to 26H

[0112] Figure 28 Schematically shows an example of a surgical drainage device that includes a plug structure formed by multiple different forms of plug components having different stiffnesses.

[0113] Figures 29A to 29B Schematically shows an example of a surgical drainage device that has a different compressible / dilatable plug attached to the rest of the device by an adhesive.

[0114] Figures 30A to 30B Schematically shows an example of a surgical drainage device that has a compressible / dilatable plug attached to the rest of the device by different variants of an adhesive.

[0115] Figures 31A to 31D Shows a schematic of an end view of a device having a compressible / dilatable plug that is attached to the rest of the device by different variants of an adhesive.

[0116] Figures 32A to 32CSchematically illustrates an example of a surgical drainage device having different plug configurations and a fixed everted tube drain.

[0117] Figures 33A to 33B Schematically illustrates an example of a surgical drainage device having different plug configurations and a fixed everted tube drain.

[0118] Figures 34A to 34B Schematically illustrates an example of a surgical drainage device having different plug configurations and a fixed everted tube drain.

[0119] Figure 35 Illustrates another example of a surgical drainage device having a fixed and everted (e.g., 2 - layer) drain tube at the distal end, the drain tube having a multi - layer plug.

[0120] Figures 36A to 36B Schematically illustrates an example of a surgical drainage device having a compressible / expandable plug attached to the shaft of the device by an adhesive, the surgical drainage device being similar to Figures 29A to 29B the example shown in

[0121] Figures 37A to 37B Schematically illustrates an example of a surgical drainage device having a compressible / expandable plug attached to the shaft of the device by an adhesive, the surgical drainage device being similar to Figures 30A to 30B the example shown in

[0122] Figures 38A to 38C Illustrates the operation of another example of a surgical drain having a passive seal with a non - everted, expandable 2 - layer porous drain attached to a retractable sheath.

[0123] Figures 39A to 39B Illustrates the operation of another example of a surgical drainage device including an expandable / compressible plug assembly that includes a covering.

[0124] Figures 40A to 40B Illustrates the operation of an example of a surgical drainage device including an expandable / compressible plug assembly that includes a plurality of strips.

[0125] Figures 41A to 41C Schematically illustrates an example of a surgical drainage device having a deconstructible plug assembly that can be removed by pulling a tether to at least partially deconstruct the plug.

[0126] Figures 42A to 42BShows the operation of another example of a surgical drainage device that includes a tether to transition the device from an expanded plug configuration to a contracted plug configuration.

[0127] Detailed description

[0128] Methods and devices (systems and apparatuses) are described herein for draining a body region to remove fluid or substances and / or contract the region from the region. Such treatment can prevent or reduce bleeding and / or can otherwise promote healing. These devices and methods, including methods of using them, can be particularly useful in regions that form a uniform negative pressure within a cavity surrounded by soft tissue and maintain the negative pressure while removing the device from the cavity without trauma. The device can be designed to be easy to use.

[0129] For example, devices including a surgical drainage system are described herein, the surgical drainage system can include an elongate tubular body, the elongate tubular body can be flexible to form an outer shaft and a distal porous drainage structure extending from a distal end region of the outer shaft. The distal porous drainage structure can have one or more (preferably two or more) porous layers through which fluid (e.g., blood, lymph, etc.) can be drawn by applying a negative pressure. The distal porous drainage structure can be referred to as a distal porous drainer or a porous structure. The distal porous drainer can include a multi-layer tube of flexible material that has a plurality of openings (e.g., holes) along its length. The multi-layers of the tube can be formed by turning a tubular porous material back on itself such that it folds back on itself. For example, the distal porous drainer can be formed from a tube of mesh (e.g., knitted, woven, and / or braided mesh) that is turned back on itself and the ends of the turned-back tube are attached more proximally. The distal end formed by the turned-back region on itself can be open or can be closed and generally can form a relatively soft, non-traumatic distal end. Thus, the distal porous drainer forms a central lumen having two tubular porous materials. Suction can be applied through the central lumen. The two (or in some cases, more) cylindrical layers forming the tubular porous drainer can allow fluid to be drawn in through the holes and can distribute the suction across the porous drainer to prevent suction lock, even when tissue compresses all or a portion of the distal porous drainer.

[0130] In some examples, the length of the distal porous drain may be static and the ends of the everted porous material (e.g., mesh) may be fixed relative to each other. Alternatively, in some examples, the distal porous drain may be extended or retracted in length, e.g., by attaching a first end of the everted distal porous drain to a first shaft (e.g., outer shaft) and attaching a second end of the distal porous drain to a second shaft (e.g., inner shaft) that is concentric with the first shaft. The first end may be everted relative to the second end. Thus, moving the first shaft relative to the second shaft may cause the distal porous drain to extend or retract distally / proximally. Embodiments in which the distal porous drain may extend or retract by winding and everting on itself may be referred to herein as a woundable drain. Embodiments in which the distal porous drain everts on itself but the ends are fixed relative to each other (e.g., both attached to a shaft such as an outer shaft) may be referred to as a non-woundable drain or equivalently as a static drain.

[0131] Devices including non-woundable drains may be manually inserted into a body region to be treated (e.g., the uterus). Devices including woundable drains may be partially inserted into the uterus (or into an opening leading to the uterus), and one or both shafts may be moved relative to each other to extend the flexible distal porous drain distally into the body region to be treated (e.g., the uterus). Alternatively, a device having a woundable drain may be manually inserted in the same manner as a non-woundable drain, but may be removed by moving one of the concentrically arranged shafts to withdraw the distal porous drain from the body. A non-woundable drain may be withdrawn from the body by pulling it proximally.

[0132] Both non-woundable drains and woundable drains may be operated in the same manner and may distribute the negative pressure (e.g., suction) applied by the device within the body region to be treated. For example, negative pressure may be applied through the pores of the porous structure to cause fluid to flow within the pores and out of the body region. This may help remove inflammatory mediators, bacteria, foreign bodies, and / or necrotic tissue, thus promoting soft tissue healing. Alternatively or additionally, negative pressure may cause at least partial contraction of the soft tissue wall surrounding the body cavity, which may reduce bleeding.

[0133] As mentioned, the distal porous drain may be formed of two or more concentrically arranged layers having pores (e.g., openings) to allow fluid passage. The pores may not overlap or may partially overlap between adjacent layers. The distal porous drain may be formed of concentrically arranged cylindrical layers. The porous layers may be formed as a mesh material. The distal porous drain may be flexible. In particular, the distal porous drain may be laterally compressible and may be compressed between tissue walls or layers; due to the multiple porous layers, the distal porous drain may not form a vacuum lock within the tissue.

[0134] The porous structure is configured to distribute negative pressure more effectively than existing surgical drains. The porous structure can have a plurality of interconnected pores distributed throughout the porous structure, which act as a network of channels for draining fluid and / or air from a body cavity (e.g., the uterus). In particular, in some examples described herein, the porous structure (e.g., a fabric, a mesh, etc.) can be formed by two or more adjacent layers. In some examples, the layers can be formed into tubes that are turned back on themselves. This can form a network of channels that provides a more uniform negative pressure over a large surface area, thereby providing effective removal of fluid and / or air and reducing variations in clogging. The porous structure is generally deformable and can at least partially conform to the tissue region in which it is positioned. In some examples, the porous structure can be a mesh, which can be made of woven, knitted, braided, and / or non-woven materials. In some instances, the porous structure is a fabric.

[0135] The distal porous drain can be formed from a tube of porous material (e.g., a mesh, a fabric, such as a knitted, woven, or braided material), the tube generally being turned back on itself at the distal end to form two or more (e.g., multiple) layered tubes. The distal end opening of the multi-layered tube can be open or closed. In some examples, the distal porous drain can be configured as a wrap-around drain that flips and wraps around itself for deployment and / or retraction. As described above, in some examples, the distal porous drain can be static such that it does not wrap around itself but is inserted into a body that has already been deployed. In both the wrap-around and non-wrap-around (static) drain examples, the distal porous drain can be compressed to conform to the width and / or height of the body region (e.g., the uterus) into which it is inserted.

[0136] The distal porous drain can be coupled to one or more elongate members (e.g., tubes, catheters, and / or rods). At least one of the elongate members can include a lumen configured to supply negative pressure (e.g., a vacuum) to the distal porous drain. The suction lumen can be coupled to the distal region of the elongate member and, thus, to the distal porous drain. In some cases, the device can include one or more additional elongate members that can assist in delivering the distal porous drain into the body region and / or retracting the distal porous drain from the body region. In some examples, the device is configured to flip the distal porous drain during delivery of the distal porous drain into the body cavity and / or evacuation from the body cavity.

[0137] Any of these devices may include a sealed connector, e.g., a seal cap or other sealing structure at the proximal end of the device, the sealed connector being configured to releasably connect the proximal end of an elongate member (e.g., a catheter, tube, etc.) to a negative pressure source. The sealed connector may include a negative pressure coupler for coupling to a tube or other negative pressure source and a distal sealing region for coupling to the distal end region of the elongate member. The sealed connector may be removable from the elongate body and may be coupled and sealed to either or both of the exterior and interior of the elongate body. Alternatively, in some examples, the seal cap may be integrated into the elongate body.

[0138] Any of these devices may also include a plug assembly ("plug") or occluder, generally on the elongate shaft, near the distal porous drainer, which may allow the treatment area to maintain negative pressure within the body area. For example, the device may include one or more plugs or plug regions configured to contact and may be configured to expand against (e.g., may be compressible and expandable) surrounding soft tissue and provide a seal with the surrounding soft tissue, such as in a duct or passage leading to the body cavity being treated. The plug assembly may be a radially expandable and contractible feature disposed proximally relative to the porous structure along the elongate member. The plug assembly may provide a blocking force (e.g., a sealing force) against the tissue of the passage. Once negative pressure is applied and a sufficient treatment time is maintained, the porous structure and plug may collapse and / or retract to gently remove from the body area. In some examples, the plug or plug region may be configured to collapse. In some examples, the plug or plug region may include a foam material (e.g., viscoelastic polyurethane foam or low resistance polyurethane foam) that may be compressed and may self-expand to fill and occlude body passages, ducts, etc. to maintain a vacuum distal to the plug. In some examples, the plug assembly may be disassembled and removed.

[0139] In some examples, the surgical drainage devices described herein may include a delivery configuration having a relatively small OD that prevents or reduces trauma when the device is inserted into tissue. For example, the distal porous drainer and / or the plug assembly may be configured to compress to a small enough OD to enter body ducts, passages, or cavities without trauma. In some cases, the distal porous drainer and / or the plug assembly may be configured to expand out of and / or retract into the elongate member of the device during deployment of the device into and / or withdrawal from the body area. The distal porous drainer and the plug assembly may be configured to compress naturally (e.g., automatically) when placed within the scope of a body duct or passage and to expand naturally (e.g., automatically) when placed within a larger body cavity or when withdrawn outside the body to apply a sealing force.

[0140] In any of the examples described herein, the distal porous drainage structure can be pushed or otherwise advanced and / or positioned into the area of the body to be drained such that, once positioned, it can remove fluid from the body area. Any tissue of the body can be treated with the surgical drain described herein. In particular, soft tissue areas such as cavities, chambers, openings, etc. formed or naturally present in tissue. The soft tissue to be treated can be a surgically or traumatically formed area of the body, such as a tunneling wound, dead space, hematoma formation pocket (surgical wound), etc. For example, the soft tissue to be treated can be a cavity formed by removing a tumor or other tissue. In some examples, the soft tissue to be treated can be a natural pore space (bladder, intestine, stomach, uterus, thoracic cavity, lung, blood vessel, etc.). For example, the soft tissue to be treated can be the uterus.

[0141] Figures 1A to 1F An example of a surgical drainage device 100 and an exemplary use of the device in a soft tissue area of the body are shown. Figure 1A A side view of the device 100 is shown, which includes an elongate member 102 (also referred to herein as an elongate shaft) and a distal porous drain 106 coupled to the distal region of the elongate member 102. In this example, the elongate member 102 is a flexible tube (e.g., a polymer tube) that includes a lumen 104. The lumen of the second elongate member 102 is in fluid communication with the distal porous drain 106. The distal porous drain in this example is formed by, for example, the distal end region of the elongate member 102, which can include one or more openings that provide a fluid path to the porous network of the distal porous drain 106. The elongate member 102 (e.g., the elongate shaft) can be any suitable length such that it can be maneuvered and position the distal porous drain 106 within the body area being treated. For example, the length of the elongate member 102 can be between 5 cm and 100 cm (e.g., between 10 cm and 50 cm, between 10 cm and 35 cm, etc.). The elongate member 102 can be straight (as shown) or curved, including curved at a fixed curvature (e.g., between 10 and 80 degrees). In some cases, the elongate member 102 can be laterally flexible.

[0142] In some cases, the elongate member 102 extends distally at least partially within the distal porous drain 106. In other cases, the elongate member 102 does not extend distally within the distal porous drain 106. In some examples, the distal porous drain 106 is configured as a wrap-around drain, and a second elongate member (elongate shaft, not shown) may be concentrically disposed within the first elongate member 102 and may be coupled to one end of the material (e.g., mesh) forming the distal porous drain. Generally, the distal porous drain 106 may be radially compressible such that the outer diameter of the distal porous drain 106 is sufficiently reduced to enter the soft tissue region. The distal porous drain 106 may be flexible and laterally deflectable (i.e., bendable) to conform to the anatomy of the body tissue. As described herein, the distal porous drain 106 may include a plurality of holes and / or a network of holes (e.g., mesh, open-cell structure) configured to draw fluid and / or air from the body cavity. In Figure 1B a cross-sectional view, the distal end of the distal porous drain 106 is shown as an open cylinder of mesh material that folds back onto itself at the distal end of the porous drain region, which may form an atraumatic distal end region; the two ends of the mesh material forming the distal porous drain may be attached to the distal end region of the elongate shaft 102.

[0143] Figure 1C A first cross-sectional view of a soft tissue region of the body is shown, the soft tissue region including a cavity 120 and a channel 122 leading to the cavity 120. The soft tissue region may be a surgical site, such as a postpartum uterus or a tumor resection site. For example, the channel 122 may include a portion of the vagina, and the cavity may include a postpartum uterus. Figure 1D A second cross-sectional view is shown (taken at Figure 1C a 90-degree offset from the view shown in

[0144] Figure 1EIllustrated is the device 100 after insertion into a body region and when negative pressure (suction) is applied. As shown, the distal porous drain 106 is positioned within the cavity 120 and the second elongated member 102 is positioned within the channel 122. In the example shown, the distal porous drain 106 and the elongated member 102 are advanced through the lumen of the elongated guide member 103. For example, the elongated guide member 103 having the distal porous drain 106 positioned therein can be advanced within the channel 122 and then, by pushing the elongated member 102 relative to the elongated guide member 103, the distal porous drain 106 can extend distally out of the elongated guide member 103 and into the cavity 120. The elongated guide member 103 can form a seal with the wall of the soft tissue wall of the channel 122 such that sufficient negative pressure can be formed within the cavity 120. The guide member is optional. In some cases, as described herein, the elongated guide member 103 is included and the elongated guide member 103 has one or more sealing features (e.g., plugs) to facilitate the seal. In some examples, the device 100 includes a plug assembly extending from the outer surface of the elongated member 102.

[0145] In some examples, one or more plug assemblies can be positioned between the elongated guide member 103 and the elongated member 102. One or more plug assemblies can be configured (e.g., shaped, positioned, formed of a suitable material, etc.) to allow the elongated member 102 to slide within the lumen of the elongated guide member 103 without requiring too much sliding force. For example, the seal can be an O-ring (or O-rings), which can be lubricated or non-lubricated.

[0146] In some examples, the distal porous drain 106 can be compressed into a compressed state prior to being advanced through the channel 122. Once within the cavity 120, the distal porous drain 106 can expand into an expanded state. In some cases, the distal porous drain 106 can at least partially change shape (e.g., bend) when inserted into the cavity 120, e.g., by pressure from contact with the surrounding tissue. In some cases, the distal porous drain 106 can be configured to assume a predetermined shape (e.g., a bent shape), e.g., to conform to the shape of a particular body cavity.

[0147] In some examples, the elongated member 103 and / or the elongated guide member 102 can include one or more stops that limit their relative axial movement. For example, the elongated member 103 and the elongated guide member 102 can be configured to lock relative to each other when the distal porous drain 106 extends distally and / or retracts proximally by a predetermined amount. In some examples, the device includes one or more locks that are configured to releasably lock the relative axial positions of the elongated member 103 and the elongated guide member 102.

[0148] Once the distal porous drainage structure 106 is deployed, negative pressure can be applied through the lumen 104 of the elongate member 102 to cause fluid and / or gas from the cavity 120 to flow proximally through the distal porous drain 106, into the elongate member 102, and ultimately out of the body tissue. For example, the elongate member 102 can include one or more openings at the distal end of the elongate member (and / or within the sidewall in the distal region of the elongate member 102). Generally, the suction lumen passing through the elongate member 102 can be in fluid communication with the lumen of the distal porous drain 111. As Figure 1F shown, even when compressed by tissue, the distal porous drain 106 can maintain a shape that provides effective flow of fluid and / or gas through the pore network of the distal porous drain 106. The negative pressure applied by the distal porous drain 106 can apply an inward force on the surrounding wall of the cavity 120 (indicated by the Figure 1E inward-facing arrow in), thereby causing the cavity 120 (e.g., the uterus) to contract at least partially. For example, such a contraction may be beneficial in cases where contracting the postpartum uterus can reduce bleeding.

[0149] In some cases where the distal porous drain 106 has a tubular shape, the application of negative pressure can flatten the outer shape of the tube, resulting in a flattened tube shape. However, the pores of the distal porous drain can sufficiently maintain their shape to allow fluid, substances, and / or air to pass therethrough.

[0150] The distal porous drainage structure 106 can be removed from the cavity 120 by moving the distal porous drain 106 proximally out of the cavity 120. For example, the distal porous drain 106 can be retracted within the elongate guide member 103. In some cases, retracting into the elongate guide member 103 can cause the distal porous drain 106 to radially contract. In other examples where the elongate guide member 103 is not used, the elongate member 102 can be pulled to directly pull the distal porous drain 106 out of the cavity 120. In examples where a plug assembly is included as part of the device, the plug assembly can optionally collapse before or when the device is removed.

[0151] The negative pressure can be maintained for a period of time to provide a therapeutic effect. For example, the negative pressure can be applied continuously until the cavity 120 is sufficiently drained of fluid and / or the cavity 120 is sufficiently contracted. In some examples, the period of time can range from one minute to several hours or even days. For example, the period of time can range from 1 minute to 5 days or longer (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.).

[0152] In some examples, after withdrawing the distal porous drain 106 from the cavity 120, negative pressure is optionally maintained within the cavity 120 for a period of time. For example, in some cases, maintaining negative pressure after removing the distal porous drain 106 can help contract the uterus and reduce uterine bleeding. In some examples, negative pressure can be applied for a period of time after withdrawing the distal porous drain 106 from the cavity 120, the duration being in the range of one minute to 10 hours (e.g., 10 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, or 10 hours). After withdrawing the distal porous drain 106, negative pressure is applied via the elongate member 102 (e.g., in a variant using a coiled drain) and / or the elongate guide member 103. Alternatively, the distal porous drain 106 and the elongate member 102 can be withdrawn proximally completely from the elongate guide member 103, and negative pressure can be applied via the elongate guide member 103. Once the treatment is complete, the distal porous drain 106, the elongate member 102, and the elongate guide member 103 can be removed proximally from the cavity 120 and the channel 122.

[0153] Any distal porous drain structure described herein can have an open pore structure, where the pores / holes / spaces within the distal porous drain are interconnected to provide multiple channels through the distal porous drain. In some examples, the distal porous drain includes a porous material (e.g., a mesh, fabric, and / or textile), and the porous material can include woven, knitted, or braided elements (e.g., filaments). In some examples, the distal porous drain can be formed from a knitted, woven, braided, non-woven sheet (e.g., a polymer or metal or mixture) of a material having pores or, more preferably, a flexible tube. For example, in a variant where the distal porous drain is formed from a braided material, the braid can include any number of filaments, such as between 24 and 144 yarns / filaments (e.g., between about 24 and 128 filaments, between about 32 and 98 filaments, etc.). In some examples, the filaments are formed from materials such as PET, nylon, PP, nitinol, steel, Elgiloy, or some combination of these materials. The filaments can have any suitable diameter, such as filaments having a diameter between 0.003 inches and 0.025 inches (e.g., monofilaments or composite filaments). In some examples, the distal porous drain is formed from 100 - 2000 denier (e.g., multifilament or monofilament) filaments (knitted, woven, braided, etc.). The mesh can have a monofilament or multifilament structure (or a mixture thereof).

[0154] In some examples, the distal porous drainage structure (“distal porous drain”) is made of a nonwoven material, such as punched material, slit material, felt, meltblown material, and / or foam material. For example, the distal porous drainage structure can be formed by extrusion, punching, stamping, blowing, laser cutting, and / or other manufacturing techniques. In some examples, the distal porous drainage structure can include an open-cell structure (e.g., open-cell or reticulated foam), the open-cell structure including interconnected pores / spaces (e.g., cell lattice). In some cases, the foam is similar to some types of wound dressing foams used with negative pressure. In some cases, the foam can be reinforced with an open textile structure (e.g., mesh tube, sheet) to hold the foam together when placed under tension. For example, the foam can be a composite foam or a fabric-covered foam. In some examples, the distal porous drain includes, for example, a pore pattern having pores of 1 mm to 4 mm (e.g., similar to a perforated structure having many pores per unit area). In some examples, the distal porous drain includes a slit pattern, for example, the slits having a width of 1 mm to 3 mm and a length of 1 mm to 15 mm.

[0155] The distal porous drainage structures described herein can be made of any of a variety of biocompatible materials. In some examples, the distal porous drain includes one or more polymers, such as polyethylene terephthalate (PET), polytetrafluoroethylene (PTFE), silicone, and / or polyurethane. In some cases, the PTFE is expanded polytetrafluoroethylene (ePTFE). In some cases, the polymer includes a thermoplastic or thermosetting material (e.g., thermoplastic or thermosetting foam). In some examples, the distal porous drain includes one or more metals (e.g., wire), such as nitinol (e.g., Nitinol), steel, Elgiloy, and / or nickel-cobalt-chromium-molybdenum alloy (e.g., MP35N).

[0156] The term “mesh” is not limited to a structure formed by one or more strands, but can be formed of a nonwoven material. The material forming the mesh can be a porous filter material, such as Tyvek, filter paper, etc., or it can be (initially) nonporous and pores can be formed therein. The term “mesh” can refer to a material having an average porosity greater than 50%, which can be formed into a flip structure compliant enough such that it can be flipped back onto itself. The mesh can be formed into a tubular or basket shape (e.g., open at both ends or closed at one end (e.g., the distal end)). In some cases, the mesh can be formed into a generally tubular shape (open at one or both ends). In some cases, the mesh can be formed into a non-tubular shape.

[0157] The distal porous drainage structures described herein can have any of a variety of shapes. In some examples, the distal porous drainage structure can have a tubular shape with an internal space (e.g., a lumen). In some cases, the distal porous drain can include a plurality of tubes (e.g., concentrically arranged) formed of a porous material. In some examples, the distal porous drain can have a non-tubular structure, e.g., where the porous material extends throughout the entire thickness of the distal porous drain (i.e., excluding an internal lumen).

[0158] In any device, one or more of the elongate members can be flexible, semi-rigid, or rigid. For example, the elongate member can be formed of polyurethane or silicone. These devices can be configured to have a reasonably high column force while maintaining bending flexibility.

[0159] In any of these examples, the proximal direction can be the direction toward the hand of the user of the operating device (e.g., a physician, surgeon, medical technician, nurse, etc.), and the distal can be the direction away from the user's hand.

[0160] Figures 2A to 2E A side view of an exemplary device having different tubular distal porous drainage structures when in an extended and / or expanded state is shown. Figures 2A to 2E Each of the tubular distal porous drainage structures shown has a porous wall (e.g., a mesh wall) that is formed within the tube such that the porous wall defines an internal lumen. The porous wall has a plurality of pores that are configured to allow fluid, material, and / or gas to pass therethrough when a negative pressure is applied. Each of the tubular distal porous drains is coupled to the distal end region of a corresponding elongate member. In each figure, suction can be applied in the proximal direction (e.g., via the elongate member to which it is coupled or another elongate member) to provide a negative pressure on the tubular distal porous drain. Each of these examples can include a plurality of adjacent layers of porous material. The multi-layers can be formed by turning a tube of porous material back onto itself, or can be formed by concentrically placing one or more tubes, bags, or sheets of porous material into another tube or bag of porous material. Suction can be applied within the innermost channel (e.g., the innermost tube or bag of porous material (e.g., mesh)) such that the suction passes through the plurality of layers.

[0161] Figure 2A A device having a tubular distal porous drain 206 coupled to the distal region of an elongate member 202 is shown, where the tubular distal porous drain 206 has an outer diameter that is substantially the same as the diameter of the elongate member 202 when the tubular distal porous drain 206 is in an expanded state. Figure 2BA device is shown having a tubular distal porous drain 216 coupled to a distal region of an elongate member 212, wherein when the tubular distal porous drain 216 is in an expanded state, the tubular distal porous drain 216 has an outer diameter greater than the diameter of the elongate member 212. Figure 2C A device is shown having a tubular distal porous drain 226 coupled to a distal region of an elongate member 222, wherein when the tubular distal porous drain 226 is in an expanded state, the tubular distal porous drain 226 has an outer diameter less than the diameter of the elongate member 222. Figure 2D A device is shown having a tubular distal porous drain 236 coupled to a distal region of an elongate member 232, wherein when the tubular distal porous drain 226 is in an expanded state, the tubular distal porous drain 236 has an outer diameter that is conical in shape. In Figure 2D In the example shown, the tubular distal porous drain 226 tapers from a larger outer diameter at the proximal end of the tubular distal porous drain 226 to a smaller outer diameter at the distal end of the tubular distal porous drain 226. In other examples, the tubular distal porous drain may taper from a larger outer diameter at the distal end to a smaller outer diameter at the proximal end. Figure 2E A device is shown having two tubular distal porous drains 246a and 246b (shown in an expanded state) coupled to a distal region of an elongate member 242. In Figure 2E In the example shown, the tubular distal porous drains 246a and 246b are in a non - parallel arrangement relative to each other. In other examples, the tubular distal porous drains may be in a parallel arrangement. An inner (second, third, fourth, etc.) layer of porous material may be within Figures 2A to 2E each of the distal porous drains shown.

[0162] The tubular distal porous drains described herein may have any one of a variety of shapes and sizes and are not limited to Figures 2A to 2E the shapes and sizes shown therein. Additionally, the devices described herein may include any number of tubular distal porous drains (e.g., 1, 2, 3, 4, 5, 6, or more).

[0163] Figures 3A1 to 3E2 A distal end view and a side view of an additional exemplary device having a tubular distal porous drain structure are shown. Figure 3A1 A distal end view of the device is shown, and Figure 3A2 a side view of the device is shown, wherein, similar to Figure 2A the device of, when the tubular distal porous drain 306 is in an extended / expanded state, the tubular distal porous drain 306 has an outer diameter that is substantially the same as the diameter of the elongate member 302. As Figure 3A1As shown in the distal end view, the tubular distal porous drain 306 has an outer porous wall 308 (e.g., a mesh wall) and an inner porous wall 311 that defines an internal space 309 (e.g., a lumen). The inner wall can be formed by flipping the mesh back to the outer wall (cylinder).

[0164] Figure 3B1 The distal end view of the device is shown, and Figure 3B2 The side view of the device having the elongated member 312 and the tubular distal end porous drainage structure 316 is shown. Similar to the tubular distal porous drain 306, the tubular distal end porous drainage structure 316 defines an internal space 319, except that the sheath 317 covers the outer surface of the tubular distal porous drain 316. When negative pressure is applied, the sheath 317 can control the amount of fluid and / or gas flowing through the tubular distal porous drain 316. For example, as Figure 3B1 shown in the distal end view, the sheath 317 does not cover the distal end of the tubular distal porous drain 306. Thus, fluid and / or gas can enter the tubular distal porous drain 316 via the open distal end. The sheath 317 can be a film made of a flexible / elastic polymer material (e.g., flexible polyurethane and / or silicone). In some cases, the sheath 317 can be made of a latex material. The sheath can have discrete openings along its length.

[0165] For example, Figure 3C1 The end view of the device is shown, and Figure 3C2 The side view of the device having the elongated member 322 and the tubular distal porous drain 326 that defines an internal space 329 is shown, and having a sheath 327 similar to the sheath 317, except that the sheath 327 includes an opening 325 (e.g., a hole) that allows fluid and / or gas to pass through the sheath 327 to enter the tubular distal porous drain 326. Compared with the sheath 317, the sheath 327 can provide a more effective passage for fluid and / or gas to reach the tubular distal porous drain 326, but is less efficient than an uncovered distal porous drain (e.g., Figure 3A1 and Figure 3A2 ).

[0166] Figure 3D1 The end view of the device is shown, and Figure 3D2 The side view of the device having the elongated member 332 and the tubular distal porous drainage structure 336 that defines an internal space 339 is shown, and having a sheath 337 similar to the sheath 317, except that the sheath 337 only partially covers the tubular distal porous drain 336. In this example, the sheath 337 covers one side of the tubular distal porous drain 336, leaving the opposite side of the tubular distal porous drain 336 exposed.

[0167] Figure 3E1 shows an end view of the device, and Figure 3E2 shows a side view of the device, which has an elongated member 342 and a tubular distal porous drain 346 that defines an internal space 349, and has a sheath 347 similar to the sheath 337, except that the sheath 347 covers both sides of the tubular distal porous drain 346. In this example, the sheath 347 forms two exposed slits 345a and 345b along the tubular distal porous drain 346.

[0168] Figures 4A1 to 4E2 shows a distal end view and a side view of another exemplary device having a different distal porous drain. Figure 4A1 shows a distal end view of the device, and Figure 4A2 shows a side view of the device, which has an elongated member 412 and a tubular distal porous drain 406 similar to the tubular distal porous drain 306 (FIG. 3A), but where the distal end of the tubular distal porous drain 406 is closed. As described above, the distal porous drain in this example may include one or more inner layers (not visible in this example); the distal end may be closed by a single layer or multiple layers of porous material (or by non-porous material).

[0169] Figure 4B1 shows a distal end view of the device, and Figure 4B2 shows a side view of the device, which has an elongated member 412 and a tubular distal porous drain 416 similar to the tubular distal porous drain 406, except that the tubular distal porous drain 416 has a flattened external shape (e.g., by squeezing the distal end closed).

[0170] Figure 4C1 shows a distal end view of the device, and Figure 4C2 shows a side view of the device, which has an elongated member 422 and a non-tubular distal porous drain 426. Compared to the tubular structure, the non-tubular distal porous drain 426 has porous material throughout the thickness of the distal porous drain 426 and does not include an internal lumen.

[0171] Figure 4D1 shows a distal end view of the device, and Figure 4D2 shows a side view of the device, which has an elongated member 432 and a distal porous drain 436 similar to the non-tubular distal porous drain 426, except that the distal porous drain 436 has a flattened outer profile.

[0172] Figure 4E1 shows a distal end view of the device, and Figure 4E2A side view of an apparatus is shown that has a first elongate member 442 and a flippable tube distal porous drain 446. The flippable distal porous drain 446 is a tube that is configured to be flipped by translating a second elongate member 441 relative to the first elongate member 442. A first end of the distal porous drain 446 is coupled to the first elongate member 442, and a second end of the distal porous drain 446 is coupled to the second elongate member 441. This configuration allows the tubular distal porous drain 446 to flip when there is a distal / proximal relative movement between the first elongate member 442 and the second elongate member 441. In the example shown, the flippable distal porous drain 446 has a circular outer shape. In other examples, the flippable distal porous drain has a different outer shape, such as a flat outer shape (e.g., similar to the flat outer shape of the tubular distal porous drain 416). In some examples, the distal porous drain may have a free (e.g., distal) end (e.g., not coupled to the second elongate member 441).

[0173] Figures 5A1 to 5A4 An example is shown of how an apparatus having a tubular distal porous drain 506 can provide a fluid path for withdrawing fluid and / or gas. The tubular distal porous drain 506 is in fluid communication with one or more elongate members 502. Figure 5A1 and Figure 5A2 A distal end view and a side view of the apparatus are shown when a negative pressure is applied within the elongate member 502 (e.g., as indicated by the arrow). The negative pressure causes a flow 550 of fluid and / or gas to pass through the pore network of the porous walls 516, 555 of the tubular distal porous drain 506 and into the internal space 509 (e.g., lumen) of the tubular distal porous drain 506. Once in the internal space 509, the flow 550 is directed proximally toward the elongate member 502 and ultimately exits the body cavity to be drained and / or aspirated. Additionally, some of the flow 550 can be axially directed proximally along and / or between the porous walls 516, 555 of the tubular distal porous drain 506 toward the elongate member 502.

[0174] Figure 5A3 and Figure 5A4The distal end view and side view of the device are shown when at least a portion of the tubular distal porous flow diverter 506 is radially compressed / flattened so that the internal space 509 is reduced or eliminated. Even if the internal space 509 is reduced or eliminated, the flow 550 of fluid and / or gas can also flow axially toward the elongated member 502 along the porous walls 516, 555 of the tubular distal porous flow diverter 506 in the proximal direction. This aspect can allow the device to work when at least a portion of the tubular distal porous flow diverter 506 is compressed by surrounding tissue in the body cavity. In addition, the pore network in the porous walls 516, 555 provides many corners and gaps along the length of the tubular distal porous flow diverter 506, which can produce a wicking effect, which can cause the fluid to travel faster.

[0175] As mentioned, in some examples, the device is configured to evert the tubular distal porous flow drain (also referred to as "wrap-around"). In some cases, an evertable tubular distal porous flow drain can reduce removal shear forces on surrounding tissue. Figures 6A to 6C A partially transparent side view of an exemplary device 600 including an invertible tubular distal porous flow guider 606 is shown. In this example, the device 600 includes a tubular distal porous flow guider 606 having a first end 607 coupled to a distal end region of a first (e.g., outer) elongated member 603, and having a second end 609 coupled to a distal end region of a second (e.g., inner) elongated member 602. Figure 6A The device 600 is shown in a state where the second elongated member 602 has been pushed distally relative to the first elongated member 603 to extend the second end 609 of the distal porous flow guider 606 distally (e.g., into a body cavity). As shown, the distal porous flow guider 606 can have a mostly single-walled tubular shape, wherein the second elongated member 602 extends into the first lumen 611 of the tubular distal porous flow guider 606.

[0176] Figure 6BIllustrated is device 600 where second elongate member 602 has been pulled proximally within first elongate member 603 such that distal porous drain 606 is partially flipped. In this partially flipped state, the wall of distal porous drain 606 is folded and folded back onto itself, forming a double-walled tubular shape defining second lumen 621 formed by distal porous drain 606. In some instances, the device may be configured to apply suction such that fluid flows in a proximal direction into second lumen 621 and out of distal porous drain 606. In the illustrated example, second elongate member 602 may be fully withdrawn distally within first elongate member 603, which may allow distal porous drain 606 extending outside of first elongate member 603 to have greater lateral flexibility (e.g., as compared to when second elongate member 602 extends distally within distal porous drain 606, such as in Figure 6A ). This may allow distal porous drain 606 to bend laterally during use, such as when it contacts a tissue wall within a body cavity. In some examples, the distal end of second elongate member 602 is positioned near the distal end of first elongate member 603 to maximize the length of distal porous drain 606 extending distally from first elongate member 603 in the double-walled tubular configuration.

[0177] In some cases, first elongate member 603 and / or second elongate member 602 may include one or more stops and / or locks to limit their relative axial movement and / or lock their relative axial positions. For example, distal porous drain 606 may be stopped and / or locked in the double-walled tubular configuration (e.g., and where second elongate member 602 is fully withdrawn distally within first elongate member 603), such as Figure 6B shown. Additionally or alternatively, distal porous drain 606 may be stopped and / or locked in the distally extended configuration and / or locked in the distally extended configuration where second elongate member 602 extends distally relative to first elongate member 603, such as Figure 6A shown, and / or may be stopped and / or locked in the withdrawn configuration where distal porous drain 603 is flipped and withdrawn into the lumen of first elongate member 603, such as Figure 6C shown.

[0178] Figure 6C Illustrated is where second elongate member 602 has been pulled further proximally such that distal porous drain 606 is almost fully flipped, thus predominantly presenting a flipped single-walled tubular shape (as compared to Figure 6AIn comparison, a third lumen 628 is formed. As shown, the distal porous drain 606 is also mostly retracted within the first elongated member 603. Further proximal movement of the second elongated member 602 can cause the distal porous drain 606 to be fully retracted within the first elongated member 603 in a flipped tubular state. The device 600 can be configured to apply negative pressure on the flip - able tubular distal porous drain 606 in any flipped state. For example, it may be beneficial to apply suction when the distal porous drain 606 is fully extended distally (e.g., Figure 6A ) to approach a more distal region of the body cavity. Alternatively or additionally, it may be beneficial to apply suction when the distal porous drain 606 is in a double - wall state (e.g., Figure 6B ), where the distal porous drain 606 may be more flexible due to the retraction of the second elongated member 602, thereby allowing the distal porous drain 606 to more easily conform to the geometry of the body cavity.

[0179] As mentioned, one of the differences between a device having a flip - able tubular distal porous drain (e.g., Figures 6A to 6C ) and a non - flip - able distal porous drain (e.g., Figures 2A to 4D2 ) is that the non - flip - able distal porous drain can have a distal end that extends freely from the elongated member (e.g., the second elongated member). That is, the distal end of the non - flip - able distal porous drain may not be connected to the elongated member. In some cases, this can allow the non - flip - able distal porous drain to bend more easily and conform to the surroundings of the body tissue.

[0180] Any device described herein can have axial flexibility such that they can bend around a structure or an uneven volume. In various variations, the device can be introduced into body orifices through natural or native channels, such as treating the uterus by passing through the vaginal cavity.

[0181] As discussed, the distal porous drain can be made of textile (e.g., mesh) material. In one example, the textile is a braided tube (e.g., 5 to 50 picks per inch (ppi)) with monofilament warp and weft (e.g., diameter from 0.005 inches to 0.1 inches) having an outer diameter in the range of 8 mm to 20 mm. In another example, the textile includes braided material having monofilaments with a diameter range of 0.005 inches to 0.1 inches, having 50 to 200 warp threads, 5 to 50 ppi, and an outer diameter range of 8 mm to 20 mm. In additional instances, the textile includes PET monofilaments with a diameter range of 0.005 inches to 0.1 inches knitted on a circular knitting machine (e.g., 36 needles).

[0182] The devices described herein can be scaled to various suitable sizes for treating soft tissue regions of different sizes and shapes. For example, in some variations, in the delivery configuration, the reversible porous drain can have a length between 10 cm and 100 cm (e.g., the length from proximal to distal). In an example where the distal porous drain is formed from a sheet of material having holes formed therethrough, the sheet can be a membrane having patterned slits, perforations, slots, shaped perforations, etc. formed through the sheet. The patterned holes in the distal porous drain can be uniform or non-uniform and can have an average pore density (porosity) of 50% or greater (e.g., 60% or greater, 65% or greater, 70% or greater, 75% or greater, 80% or greater, 85% or greater, 90% or greater, 95% or greater, etc.).

[0183] As discussed herein, any device can include one or more sealing features that assist in sealing the device relative to tissue, such as within a passageway, such that a negative pressure can be formed for adequate drainage and / or contraction of a body cavity. Figures 7A to 7C An exemplary device 700 having a sealing feature is shown, as well as an exemplary use of the device in a soft tissue region of the body. Figure 7A A side view and a partially transparent view of the device 700 are shown. The device 700 includes a first (e.g., outer) elongate member 703 and a second (e.g., inner) elongate member 702, and a distal porous drain 706 coupled to a distal region of the second elongate member 702. Additionally, a plug 730 (also referred to as a stopper) is positioned around a portion of the first elongate member 703 near the distal porous drain 706. The plug 730 can be made of an elastic body formed from an elastic material (e.g., foam or sponge) that can be radially compressed (e.g., when positioned within the passageway 722 and removed from the passageway 722) and return to an expanded state to create a seal against the tissue wall. In some cases, the plug 730 can include one or more covers configured to apply a radially compressive force on the elastic body to reduce the outer diameter of the plug 730. The plug 730 can be arranged such that the lumen of the first elongate member 703 passes through the plug 730, thereby allowing the second elongate member 702 to pass through and for applying suction to the distal porous drain 706 via the first elongate member 703 or the second elongate member 702.

[0184] Figure 7B A cross-sectional view of a soft tissue region of the body is shown, which includes a cavity 720 and a passageway 722 leading to the cavity 720. The soft tissue region can be a surgical site, such as a postpartum uterus or a tumor resection site. For example, the passageway 722 can include a portion of the vagina, and the cavity can include a postpartum uterus.

[0185] Figure 7C Illustrated is device 700 after insertion into a body region and when negative pressure is applied. As shown, distal porous drain 706 is positioned within cavity 720, and first elongate member 702 has a plug 730 positioned within channel 722. The diameter of the first elongate member 702 may not be sufficient to seal cavity 720. However, the plug 730 can expand within the channel to form a seal with the wall in the soft tissue wall of channel 722 such that sufficient negative pressure can be formed within cavity 702. Once the distal porous drain 706 is released within cavity 720, negative pressure can be applied (e.g., through the lumen of first elongate member 703 and / or second elongate member 702) to cause fluid and / or gas from cavity 720 to flow proximally through the distal porous drain 706 and ultimately out of the body tissue. Alternatively or additionally, the negative pressure applied by the distal porous drain 706 can apply an inward force on the wall surrounding cavity 720 (indicated by the inward-facing arrows), thereby causing cavity 720 (e.g., the uterus) to contract at least partially.

[0186] After sufficient time of negative pressure, the distal porous drain 706 can be retracted from cavity 720. For example, the second elongate member 702 can be pulled relative to the first elongate member 703 to pull the distal porous drain 706 into the lumen of the first elongate member 703. As described herein, in some examples, after withdrawing the distal porous drain 706 from cavity 720, the negative pressure is optionally maintained within cavity 720 for a period of time. Once the treatment is complete, the distal porous drain 706, second elongate member 702, and first elongate member 703 can be removed proximally from cavity 720 and channel 722. The plug 730 can be radially compressed prior to removal of the first elongate member. In some examples, the plug 730 is configured to be compressed by a cover / sheath configured to reduce the radial geometry of the plug.

[0187] Figure 8An exemplary device with a plug assembly 830 is shown. In this case, the expansion and contraction of the plug 830 are controlled by the axial movement of the proximal connector 838. The plug 830 may include an elastomeric body (e.g., foam or sponge) that can be radially compressed and expanded. The plug 830 may include a covering 833 that covers the elastomeric body. The proximal connector 838 may slidably connect the proximal side of the covering 833 to the first elongated member 803, and the distal connector 839 fixedly connects the distal side of the covering 833 to the first elongated member 803. The covering 833 may be made of any of a variety of materials. In some cases, the covering 833 may include one or more layers of material. In some examples, the covering 833 may include a sheet of polymeric material (e.g., polyethylene (e.g., lightweight), nitrile) and / or a mesh material. At least one layer of the covering 833 (e.g., a compression layer) may be axially tightened and loosened to control the size of the outer diameter of the plug 830. The proximal connector 838 may be activated to control the size of the outer diameter of the plug 830 by sliding relative to the first elongated member 803. For example, the proximal connector 838 may be pulled proximally (e.g., by hand or via an actuator) to axially elongate and tighten the covering 833, thereby applying a radially inward pressure on the elastomeric body of the plug 830. The radially inward pressure may radially squeeze the elastomeric body and reduce the outer diameter of the plug 830. In some cases, the covering 833 includes additional layers or membranes (e.g., a fluid barrier layer or membrane) configured to provide a fluid barrier and / or improve the seal of the plug 830 with the surrounding tissue. In some examples, a single layer may be used to compress the elastomeric body and provide a fluid barrier. For example, during insertion or repositioning of the plug 830 within a body passage, the outer diameter of the plug 830 may be reduced. Once in the desired position within the body passage, the proximal connector 838 may be released to loosen the covering 833 and release the radially inward pressure on the elastomeric body of the plug 830, thereby causing the plug 830 to expand and create a seal against the tissue wall within the body passage.

[0188] As Figure 8 shown, the plug assembly 830 includes an opening (e.g., a central opening) that receives the first elongated member 803, and the first elongated member 803 provides suction to the distal porous drainer 806. In this example, the device includes a flippable tubular distal porous drainer 806 that is configured to transition between a tubular state and a flipped tubular state as the second elongated member 802 moves proximally and distally, and the second elongated member 802 is coupled to the distal porous drainer 806. Also in the example shown, the vacuum port 842 is configured to supply negative pressure to the distal porous drainer 806 via the lumen of the first elongated member 803 and / or the second elongated member 802.

[0189] Figure 9An exemplary plug assembly 930 is shown, where the elastic body 934 has a covering 933, and the covering 933 is an expandable mesh. The outer diameter of the elastic body 934 can be reduced by pulling the proximal connector 932 to elongate the covering 933, thereby applying a radially inward force on the elastic body 934. By releasing the proximal connector 932 to provide slack in the covering 933, the outer diameter of the elastic body 934 can return to its original size, thereby releasing the radially inward force on the elastic body 934. In some cases, the mesh covering 933 is covered by an additional layer that can serve as a fluid barrier.

[0190] Figures 10A to 10B Another exemplary plug assembly 1030 is shown. The outer surface of the elastic body 1034 is covered by a covering that includes a compression layer 1033 and a fluid barrier layer 1036. Figure 10A The plug 1030 is shown in a radially expanded state, Figure 10B The plug 1030 is shown in a radially compressed state. The plug 1030 is positioned around a long member 1003 (e.g., a first long member). The distal ends of the compression layer 1033 and the fluid barrier layer 1036 are fixedly coupled to the long member 1003 via a first (e.g., distal) connector 1039. The proximal ends of the compression layer 1033 and the fluid barrier layer 1036 are slidably coupled to the long member 1003 to a second (e.g., proximal) connector 1038. In this example, the second connector 1038 has a long proximal 1032 that can serve as a handle. The first connector 1039 and the second connector 1038 can be referred to as hoops or collars. In some examples, the first connector 1039 and the second connector 1038 include straps (e.g., elastic straps) and / or washers. As Figure 10B shown, driving the second connector 1038 in the proximal direction (e.g., by pulling the handle 1032 by hand or by an actuator) causes the compression layer 1033 to elongate and apply a radially compressive force on the elastic body 1034, thereby reducing the outer diameter of the elastic body 1034 and the plug 1030. Releasing the proximal axial force applied on the second connector 1038 (e.g., by releasing the handle 1032) causes the compression layer 1033 to slacken and release the radially compressive force, thereby reducing the outer diameter of the elastic body 1034 and the plug 1030, as Figure 10B shown. In some examples, the radially expanded state of the elastic body 1034 can be enhanced based on the degree of distal axial displacement of the second connector 1038 and the amount of axial force applied distally on the elastic body 1034 ( Figure 10A ). For example, a sufficient distal axial force can be applied on the second connector 1038 to axially compress the elastic body 1034, which can make the elastic body 1034 in the expanded state become firm and enhanced.

[0191] In some cases, the plug assembly 1030 may include one or more stoppers and / or locking members that limit and / or lock the axial position of the second connector 1038 (and handle 1032) relative to the first connector 1039. For example, the second connector 1038 may include a lock that releasably locks the axial position of the second connector 1038 relative to the elongated body 1003. Thus, in the case of the lock, the resilient body 1034 can be locked in a radially expanded state (e.g., Figure 10A ) or a radially compressed state (e.g., Figure 10B ).

[0192] The fluid barrier layer 1036 can be a thin layer of fluid-resistant material. In some examples, the fluid barrier layer 1036 can be made of polyethylene (e.g., lightweight polyethylene), nitrile, or a nitrile-like low-stretch material. The thickness of the fluid barrier layer 1036 can vary depending on the material. In some examples, the fluid barrier layer 1036 has a thickness in the range of about 0.0001 inches to 0.01 inches. The compression layer 1033 can have a relatively high tensile strength such that it can apply a radially inward pressure on the resilient body 1034. In some cases, the compression layer 1033 is a tubular net. In one example, the compression layer 1033 is a tubular fabric braid having a diameter between about 3 inches and 5 inches and having about 100 - 200 monofilaments with diameters between about 0.005 inches and 0.1 inches. The resilient body 1034 can be made of any of a variety of resilient materials, such as polymer foam or sponge material. In some examples, the resilient body 1034 has flat sides (in the axial direction) to form a predetermined angle 1031 between the resilient body 1034 and the elongated member 1003. In some cases, the predetermined angle is about 90 degrees (perpendicular), which can allow the resilient body 1034 to undergo the maximum diameter change within a unit pull length.

[0193] Figures 11A to 11C An exemplary plug assembly 1130 similar to the plug assembly 1030 is shown, except that the plug assembly 1130 includes three resilient bodies 1134a, 1134b, 1134c that are configured to provide an enhanced expansion force upon expansion. Figure 11A The plug assembly 1130 is shown in an expanded state, Figure 11B the plug assembly 1130 is shown in an enhanced expanded shape, and Figure 11CShows the plug assembly 1130 in a compressed state. The resilient bodies 1134a, 1134b, 1134c can be configured to slide axially relative to the elongated member 1103 such that driving the second connector 1132 distally (e.g., by pushing the handle 1132 distally) can drive the first connector 1138 toward the second connector 1139, thereby pressing the resilient bodies 1134a, 1134b, 1134c against each other and enhancing the expanded state of the plug 1030. In some cases, washers 1140 and 1141 are positioned proximal and distal to the resilient bodies 1134a, 1134b, 1134c respectively to enhance the thrust. In some cases, the first connector 1138 and the second connector 1139 and / or the washers 1140 and 1141 can be configured to lock the resilient bodies 1134a, 1134b, 1134c in a radially expanded state ( Figure 11A ), an enhanced radially expanded state ( Figure 11B ) and / or a radially reduced state ( Figure 11C ). Similar to the plug assembly 1030, the plug assembly 1130 includes a covering that includes a compression layer 1133 and a fluid barrier layer 1136.

[0194] Figures 12A to 12B An exemplary plug assembly 1230 similar to the plug assembly 1030 is shown, except that the plug assembly 1230 is configured to fold the resilient body 1234 to reduce its radial dimension. The position of the resilient body 1234 can be configured to remain axially fixed relative to the elongated member 1203. When the second connector 1238 is driven proximally (e.g., by pulling the handle 1232), the first connector 1239 prevents axial movement of the resilient body 1234 in the distal direction, and the resilient body 1234 folds radially inward (e.g., in the proximal direction) to reduce the diameter of the plug 1230, as Figure 12B shown. In some cases, a stop 1240 (e.g., a band or washer fixedly coupled to the elongated member 1203) can prevent axial movement of the resilient body 1234 in the proximal direction when the handle 1232 is pulled proximally. Additionally or alternatively, the resilient body 1234 can be fixed to the elongated member 1203, for example, by an adhesive (e.g., glued). Once the handle 1232 is released, the compression force is released such that the resilient body 1234 can maintain its expanded state ( Figure 12A ). Similar to the plug assembly 1030, the plug assembly 1230 includes a covering that includes a compression layer 1233 and a fluid barrier layer 1236.

[0195] Figures 13A to 13BAn exemplary plug assembly 1330 is shown that is similar to plug assembly 1030, except that plug assembly 1330 is configured to compress the resilient body 1334 by rotating the second connector 1338 relative to the elongated member 1303 (e.g., by rotating the handle 1332). Rotating the second connector 1338 relative to the elongated member 1303 causes the compression layer 1333 to twist and generate an inward compressive force on the resilient body 1334, as Figure 13B shown. As described above, plug assembly 1330 may include one or more locks that are configured to lock the resilient body 1334 in a radially expanded and / or radially compressed state. For example, the radial position of the handle 1332 relative to the elongated member 1303 may be locked (e.g., by a lock on the second connector 1338 and / or a separate lock) to hold the compression layer 1333 in a twisted and / or untwisted state. When the second connector 1338 is allowed to unwind, the compressive force is released and the resilient body 1334 returns to the expanded state (e.g., Figure 13A ). Similar to plug assembly 1030, plug assembly 1330 includes a covering that includes a compression layer 1333 and a fluid barrier layer 1336.

[0196] Figures 14A to 14D An exemplary plug assembly 1430 is shown that is similar to plug assembly 1030, except that the resilient body 1434 is axially positioned near or at the distal end of the elongated member 1403. For example, as described herein, the resilient body 1434 may be axially closer to the distal porous drainer ( Figure 14A and Figure 14B not shown). In this example, when in the expanded state, the distal portion of the resilient body 1434 is positioned distally beyond the distal end of the elongated member 1403 ( Figure 14A ). The more distal position of the resilient body 1434 may be well suited for situations where the body passage is shorter, such as a relatively short cervical canal. When the handle 1432 is pulled proximally, the resilient body 1434 may be configured to axially displace in the proximal direction relative to the distal end of the elongated member 1403, as Figure 14B shown in the example of. Similar to plug assembly 1130, plug assembly 1430 includes a covering that includes a compression layer 1433 and a fluid barrier layer 1436.

[0197] In Figure 14C and Figure 14D , plug assembly 1430 is coupled to the distal porous drainer 1406. In this example, the distal porous drainer 1406 is a tubular structure configured to be flipped, as described herein. Figure 14CShown is a distal porous drain 1406 that extends distally beyond the plug 1430, for example, when suction is applied to drain and / or contract a body cavity (e.g., the uterus). To retract the distal porous drain 1406, a second (e.g., inner) elongated member 1402 (which is coupled to the distal end of the tubular distal porous drain 1406) can be pulled proximally relative to the elongated member 1403 (e.g., an outer elongated member), thereby causing the tubular distal porous drain 1406 to flip within the elongated member 1403 and retract proximally.

[0198] Figure 15 Shown are exemplary shapes (axial and radial cross-sections) of the elastic body in the expanded state. The exemplary elastic bodies of A1 and A2 have a rectangular axial cross-section as shown in A1 (axially with respect to the central opening 1501 of the elongated body) and a circular radial cross-section as shown in A2 (radially with respect to the central opening 1501). The exemplary elastic bodies of B1 and B2 have a rectangular axial cross-section as shown in A1 and an elliptical (e.g., oval) radial cross-section as shown in B2. The exemplary elastic bodies of C1 and C2 have a rectangular axial cross-section as shown in C1 and a circular radial cross-section as shown in C2, where the circular radial cross-section has a radially extending slit or opening 1555. The exemplary elastic bodies of D1 and D2 have a circular axial cross-section as shown in D1 and a circular radial cross-section as shown in D2. The exemplary elastic bodies of E1 and E2 have an elliptical (e.g., oval) axial cross-section as shown in E1 and a circular radial cross-section as shown in E2.

[0199] As mentioned, any of the devices described herein can include one or more locks that are configured to maintain the relative axial position of the distal porous drain relative to the first elongated member, and / or to hold the plug in a radially expanded and / or radially compressed state. In some cases, the lock can allow the relative position to be maintained until an additional force is applied to overcome the holding force. For example, the lock can be a ratchet element at the proximal end of the device (e.g., on the handle or a portion of the handle at the proximal end).

[0200] Figures 16A to 16B Shown is an exemplary flippable tubular distal porous drain 1606 that is configured to assume a kinked shape when extended from the first elongated member 1603. Figure 16A Shown is the tubular distal porous drain 1606 in a mostly flipped state retracted within the first elongated member 1603. Figure 16BThe tubular distal porous drain 1606 is shown after being advanced distally relative to the first elongated member 1603 (e.g., by pushing the second elongated member 1602). As shown, the tubular distal porous drain 1606 is biased to assume a bent configuration (e.g., a "C" shape) upon expansion. Such a configuration may be useful where the body cavity has a bent or curved shape and / or where certain regions of the body cavity are difficult to access. Additionally, the tubular distal porous drain 1606 can be flexible to conform to body tissue, thereby preventing damage to the tissue. The distal porous drains described herein can be configured to assume any of a variety of bent shapes (e.g., banana shape, "S" shape, "J" shape, etc.) and are not limited to Figure 16A and 16B the exemplary "C" shape. Additionally, any distal porous drain (tubular, non-tubular, reversible, non-reversible) described herein can be configured to assume a curved shape and is not limited to Figure 16A and Figure 16B the exemplary reversible inverse tubular distal porous drain.

[0201] Figures 17A to 17F An exemplary device 1700 is shown that includes a reversible distal porous drainage structure ("distal porous drain") 1706 and a plug 1730. These figures show the reversible distal porous drain 1706 in a partially inverted state, where the wall of the distal porous drain 1706 is folded back on itself to form a double-walled tubular configuration (e.g., similar to Figure 6B ). In this configuration, the second elongated member 1703 (which is coupled to the second (e.g., distal) end of the tubular distal porous drain 1706) is retracted into the first elongated member 1702. This can provide the distal porous drain 1706 with greater lateral flexibility, e.g., when traversing through a body cavity, compared to when the second elongated member 1702 is extended distally into the distal porous drain 1706. The plug 1730 includes an internal elastic body (e.g., a porous polymeric material) and a covering that is coupled to the first elongated member via a first connector 1739 and to a plug handle 1732 via a second connector 1738. In this example, the covering includes a compression layer (e.g., a mesh) and an outer fluid barrier layer.

[0202] Figures 18A to 18B An exemplary surgical drainage device 1800 is shown that is similar to the surgical drainage device 1700, except that the reversible distal porous drainage structure 1706 is configured to assume a bent shape ("C" shape) when expanded to the double-walled tubular configuration as shown in Figure 18B .

[0203] Figure 19A flowchart depicting an exemplary method of treating a body region using the apparatus described herein. The body region can be a wound, body cavity, duct, passage, or postpartum uterus. The method includes positioning at least a portion (e.g., the distal end) of a distal porous drain into the body region 1901. The distal porous drain can have apertures of a sufficient size to permit the passage of fluids (liquids and gases) and, in some cases, biological debris (e.g., pus, clots, etc.) without significant resistance. The distal porous drain can be configured to assume a shape that distributes negative pressure within the body region. The distal porous drain can have multiple layers (e.g., can be formed from a turned - inside - out mesh), and have a first end (e.g., proximal end) of a distal region coupled to an elongate member and a second end (e.g., distal end) that extends freely from the elongate member. For example, the distal porous drain can have a tubular shape with a porous wall, where the porous wall terminates at the distal end of the distal porous drain. In some cases, the distal porous drain is a non - tubular structure. In some cases, the distal porous drain has a porous wall that folds back upon itself at the distal end of the distal porous drain (e.g., a reversible distal porous drain).

[0204] Before, during, or after releasing the distal porous drain structure within the body region, the method can include creating a seal to maintain a vacuum within the body region 1903. In some cases, the outer surface of the elongate member coupled to the distal porous drain is configured to form a seal with the surrounding tissue near the body region (e.g., within a passage). In some examples, the elongate member includes a plug positioned proximal to the distal porous drain, the plug having an expandable outer diameter to assist in forming the seal. The plug can include an internal elastic (e.g., viscoelastic foam) body and a compression layer surrounding the elastic body and configured to apply a compressive force to reduce the diameter of the elastic body. The elastic body can be configured to radially compress and / or fold to reduce the diameter of the plug (e.g., for insertion into a passage). The elastic body can be made of an elastic material such as foam (e.g., a porous polymeric material). The plug can optionally include a fluid barrier (e.g., a layer) to prevent fluids from contacting the elastic body and / or the compression layer. The plug can optionally include a lock configured to lock the plug in a radially expanded and / or compressed state. The device can be configured to activate the plug via a handle, the handle being configured to elongate, shorten, and / or twist the compression layer.

[0205] Negative pressure 1905 can then be applied via the distal porous drainer (e.g., by applying negative pressure through the lumen of the elongate member). In some cases, the negative pressure can be maintained for about 1 minute to 5 days or longer (e.g., 1 minute, 5 minutes, 10 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 12 hours, 24 hours, 2 days, 3 days, 4 days, etc.). Once the body area has been drained and / or contracted and sufficient negative pressure has been applied, the distal porous drainer 1907 can be removed (withdrawn) from the body area. For example, the elongate body can be pulled proximally, thereby withdrawing the distal porous drainer by means of the elongate body. In some examples, e.g., by pulling a second (e.g., inner) elongate member coupled to the distal porous drainer, the distal porous drainer is retracted into the elongate member. In the case where the distal porous drainer is a flip - over distal porous drainer, the distal porous drainer can be flipped when retracted into the elongate member.

[0206] In some examples, after withdrawing the distal porous drainer from the body area, the negative pressure can optionally be maintained within the body area for a period of time 1909. In certain cases, this may help to contract the body area and reduce bleeding, such as uterine bleeding in some postpartum cases.

[0207] As described above, any of the surgical drainage devices described herein can include a connector for quickly and securely (but releasably) coupling the distal porous drainage structure to a negative pressure source. For example, any of these devices can include a sealed connector (also referred to as a sealed cap in some examples). For example, Figures 20A to 20B Another example shows a portion of a surgical drainage device including a removable sealed cap. In this example, the surgical drainage device can include a plug assembly, which is not shown for simplicity in Figures 20A to 20B In this example, the sealed connector 2000 is shown connected to the proximal end of the surgical drainage device (or can be integral with the proximal end of the surgical drainage device). The surgical drainage device includes an elongate member formed as a soft polymer outer tube shaft 2003 and an inner hollow shaft polymer inner tube 2007. The distal end regions of each of the inner tube 2007 and the outer tube 2003 are attached to the ends of a distal porous drainer, which is configured as a wrap - around drainer 2005 in this example. The sealed connector on the proximal end of the device can be fitted onto the proximal end of the inner shaft tube 2007 (e.g., on it or in some examples, in it), such that the lumen of the inner shaft tube is aligned with the suction lumen of the port connected to the connector. An inner cap seal 2011 can form a sealed connection on and / or within the inner shaft tube. Figures 20A to 20B The sealed connector shown in Figure 20BAs shown. By advancing the proximal end of the inner tubular shaft (to which the seal connector is attached) distally, the seal connector can be inserted into the outer catheter, and the cap can be sealed to the outer catheter, as Figure 20B shown. In Figure 20A , the distal porous drainer is configured as a wrap-around drainer 2005 and is shown in an undeployed (e.g., retracted) configuration. Figure 20B A wrap-around drainer 2005’ in a fully deployed state is shown, such that, as described above, the tubular mesh extends fully from the device, and negative pressure (e.g., vacuum) can be applied through the device and distributed within the body cavity through the two-layer cylindrical mesh structure of the wrap-around drainer. In Figures 20A to 20B , the negative pressure tube 2013 is coupled to the pressure connector, and thus negative pressure is applied through the lumen of the inner shaft 2007 and exits from the wrap-around drainer.

[0208] Figures 21A to 21B Another example of a seal connector 2100 similar to that shown in Figures 20A to 20B is shown, which is coupled to the proximal end of the device. In Figure 21A , the seal connector (e.g., seal cap) 2100 is coupled to a negative pressure source. In this example, the negative pressure port 2113 on the seal connector is coupled to the negative pressure tube 2113. The inner member is advanced distally to extend the wrap-around drainer 2105 from the internal configuration ( Figure 21A shown in) to the deployed configuration ( Figure 21B shown in). In this example, the seal connector 2100 includes an internal sealing surface 2111 that is configured to conform to the inner diameter of the tubular outer shaft 2103 to form a seal. As in Figures 20A to 20B , the seal connector may include one or more gaskets (e.g., annular gasket 2001) to assist in forming and / or maintaining the seal. The seal connector (e.g., seal cap) may also be coupled to an inner rigid shaft or member 2123 (e.g., an inner rigid wrap-around drainer deployment shaft). Advancing the seal connector 2122 distally relative to the outer shaft 2003 can cause the distal porous drain structure (e.g., wrap-around drainer) 2105 to extend / deploy and can seal the negative pressure port 2113 that communicates with the lumen of the tubular outer shaft, such that suction can be applied through the flexible distal porous drain structure, as Figure 21B shown.

[0209] Figures 22A to 22BAnother example of a surgical drainage device is shown, in which a sealed connector (sealed cap 2200) is shown. The sealed connector in this example is configured to connect and seal the outer shaft of the elongate member 2203 and is also connected proximally to a negative pressure source at the negative pressure port 2213. Thus, the sealed connector 2200 includes a tapered inner surface 2219 into which the proximal end of the outer shaft can fit to form a seal. The tapered inner surface may also include one or more gaskets (e.g., annular gasket 2301), as Figures 23A to 23B shown. In Figures 22A to 22B , the sealed connector is also coupled to an elongate inner member 2223 that is connected proximally to one end of a distal porous drainage structure (e.g., a coiled drain) 2205, 2205'. Thus, in this case, advancing the inner member 2223 distally deploys the flexible distal porous drainage structure (coiled drain), as Figure 23B shown. When the sealed connector is coupled to the inner member 2223, connecting the sealed connector 2222 to the outside of the elongate outer shaft 2203 both deploys the coiled drain and couples the coiled drain at the distal end of the device to a suction source (negative pressure) at the proximal end of the device.

[0210] Figure 23A Figures 23 are similar to the example shown in Figures 21A to 21B . In this example, the sealed connector 2300 also includes a negative pressure port 2313 for connection to a negative pressure source (e.g., via a tube) and an inner sealing surface 2319. In this example, the inner sealing surface is not tapered but includes a pair of annular gaskets 2301 (one or more annular gaskets may be used). The outer elongate shaft 2303 of the device can be inserted into the sealed connector and form a seal with the sealed connector within the opening leading to the sealed connector. In an example including a coiled drain 2205' as described above, the sealed connector may optionally be connected to the inner shaft 2223. For example, as Figure 23B shown, advancing 2322 the sealed connector over the outer shaft 2303 can seal the lumen of the outer shaft to communicate with the negative pressure port and the negative pressure source. Figures 20A to 20B , Figures 21A to 21B , Figures 22A to 22B and Figures 23A to 23B Any of the exemplary devices shown may also include a plug assembly (not shown).

[0211] Figures 24A to 24F An example of a sealed connector that can be used with any of the surgical drainage devices described herein is shown. In this example, the sealed connector 2421 is shown coupled to the distal end of the outer shaft 2403, thereby forming a seal between the sealed connector (and thus the negative pressure source connected to the negative pressure port 2413 of the sealed connector) and the lumen of the outer shaft 2403. Figures 24A to 24FThe exemplary device shown includes an inner shaft coupled to one end of a flexible distal porous drainage member (not shown) such that it can be retracted or deployed.

[0212] Any of these seal connectors may also include a gripping area 2414 (e.g., a finger gripping area) to make it easier to manipulate the connector when removing the connector or placing it on the outer shaft. Figure 24C An end view of the distal end of the device is shown, including a suction tube lumen 2416 (also shown in Figure 24E and Figure 24F ). The proximal end in this example forms a negative pressure port 2413 and may be tapered to fit into a tube connected to a negative pressure source (e.g., suction). Figure 24F The cross-sectional view in Figures 32A to 32C also shows a tapered inner surface of the distal opening for engaging the outer surface of the outer shaft 2403, and a deployment shaft engagement area 2418 for engaging the inner shaft as described above. The deployment shaft engagement area is optional because in some examples, the seal connector is used with a device including a static (non-winding) distal porous drainage member (as described above, and shown in Figures 33A to 33B 、 Figures 34A to 34B 、 Figure 35 、 Figures 36A to 36B 、 Figures 37A to 37B 、 Figures 41A to 41C and Figures 42A to 42B ).

[0213] Figures 25A to 25E Another example of a seal connector (seal cap) as described herein is shown. In this example, the seal connector 2500 (seal cap) includes a negative pressure port 2513, a finger gripping area 2514, and a distal engagement surface. The negative pressure port 2513 is at the proximal end for connection to a negative pressure source, and the distal engagement surface is for sealing to the inner elongated shaft and / or outer elongated shaft of the device to connect the negative pressure source to the distal porous drainage member. In Figure 25A , the seal connector 2500 is shown connected to the outer shaft 2503 of a surgical drainage device by inserting the outer shaft lumen over the outer sealing surface 2524 of the distal engagement surface. The outer sealing surface 2524 of the distal engagement surface may be tapered and / or may have a non-smooth profile to form a seal between the inner diameter of the outer shaft 2503 and the outer sealing surface 2524 of the distal engagement surface. In the example of the surgical drainage device shown in Figures 25A to 25E , the device includes an internal deployment shaft for deploying or retracting the distal porous drainage member. The seal connector may also include an optional internal deployment shaft engagement area 2518, as shown in Figure 25E . Generally, the seal connectors described herein may also be configured for use with static (non-winding) distal porous drainage members.

[0214] As discussed in detail above, the surgical drainage devices described herein can be configured to include a compressible and expandable (e.g., self-expanding) plug assembly. In some examples, the plug assembly can include an annular foam member that can at least partially extend around the outer surface of the elongated outer member of the device to seal or otherwise prevent air and / or fluid from flowing out of the area being drained. For example, Figures 26A to 26H Side views of various examples of the annular foam member are shown. In Figure 26A , a portion of the plug or plug assembly can include an annular foam material (shown in the side view in Figures 26A to 26H ) that can be compressible and can expand outwardly by itself to provide a sealing force against the body area into which it is inserted. The plug assembly can include any suitable material, including foam materials. The foam material can be open-cell foam 2651 material ( Figure 26A ) or closed-cell foam 2652 material ( Figure 26B ). Thus, generally, in Figures 26C to 26H , the general foam 2658 material can be open-cell or closed-cell foam. For example, Figure 26C shows a portion of a plug assembly that includes a fluid-impermeable material covering one side (e.g., the distal side) of the foam plug. Even when using open-cell foam, this configuration can help maintain the seal of the body passage or pathway. In Figure 26D , the plug assembly includes a fluid-impermeable covering on the opposite side (e.g., the proximal side) of the foam plug. In some cases, both sides (or all sides) of the foam plug can be covered. The covering can be a biocompatible polymer (e.g., silicone, latex, etc.). The covering material can have a relatively high hardness (e.g., between about 30 - 45, between about 40 - 60, etc. on a Shore 00 durometer). As described above, the foam can be viscoelastic polyurethane foam or low-resistance polyurethane foam. In some examples, the foam includes a barrier on one side but is open on the other side (which can help with compression / expansion in open-cell foam). The plug assembly (including a foam ring in some examples) can be mounted to the tubular body of the device, as described in detail above. In some examples, the plug assembly is mounted to the tube; in some examples, the plug assembly can be slidable on the tube to allow adjustment to the patient's anatomy while still forming a plug. In some examples, the barrier material can be applied by spraying, dipping, painting, etc. The barriers 2653, 2653', 2655 can be referred to as epidermis.

[0215] In some examples, the barrier or covering 2565 on or around the foam 2658 subassembly of the plug can be a covering. As Figure 26F shown, the covering 2656 can be applied loosely, or as Figure 26HAs shown, the foam can be applied tightly (e.g., attached to). In some examples, one or both lateral sides of the foam plug assembly can be covered, as Figure 26G shown, showing a partial covering 2662. The skin or covering materials described herein, particularly those that are tightly attached to the surface of the foam material, can also help distribute the occlusive force over the surface of the plug when the plug is inserted into a body region and expands or is allowed to expand.

[0216] Figures 27A to 27G showing an example of a device showing different plug assemblies formed by one or more plug components similar to those shown in Figures 26A to 26H . Generally, plug components of different sizes (height, width, and / or thickness) and materials (including different foam materials) can be used, and these different plug components can be spaced differently (or adjustably spaced) along the length of the outer axis of the device. For example, in Figures 27A to 27G , the devices shown each include an outer axis 2703 and a distal porous drainage structure configured as a wrap-around drainer (although a non-wrap-around distal porous drainage structure can alternatively be used), and the distal porous drainage structure is connected to an internal member (e.g., a hollow soft polymer tube inner axis 2707). In Figure 27A , the plug assembly 2732 includes a plurality (e.g., 5 are shown) of foam 2758 rings or disks positioned on the outer axis, with a gap or space between each ring or disk. In some examples, a covering or skin can be applied to all or some of these foam sub-components.

[0217] Figure 27B showing an example similar to that shown in Figure 27A , but without any spacing between the foam plug components of the plug assembly 2732. In Figure 27C , the foam plug components are wider than those shown in Figures 27A - 27B , but are arranged as shown in Figure 27B . In Figure 27D , the foam 2758 sub-components of the plug 2732 assembly are similar in width but different in height. Figure 27D showing an example similar to that shown in Figure 27D but with different heights and widths, where the foam 2758 sub-components of the plug assembly 2732 are arranged with increasing height and increasing width in the distal-to-proximal direction. Figure 27E and Figure 27F show the arrangement of the foam 2758 sub-components, where the height of the foam sub-components first increases to a maximum and then decreases along the proximal-to-distal length; in Figure 27E , the arrangement is symmetric, while in Figure 27G , the foam 2758 sub-components have a greater width in the proximal direction of the plug assembly 2732.

[0218] Figure 28 An example is shown where the foam sub - assemblies of the plug assembly 2832 have different mechanical properties. For example, in Figure 28 , the plug 2832 includes the innermost foam sub - assembly formed of a soft foam material 2859, while each adjacent foam sub - assembly has a reduced softness. For example, the intermediate foam sub - assembly 2859' is a medium - hard foam material, and the outermost foam sub - assembly 5859'' is a hard foam material. The plug 2832 is positioned on the outer shaft 2803 of the device. Although this example also includes a distal porous drainage structure 2805' configured as a wrap - around drainer and including an internal member 2807, a non - wrap - around distal porous drainage structure may alternatively be used.

[0219] In some examples, it may be beneficial to fix the plug assembly (or a part of the plug assembly, such as a foam sub - assembly) to the shaft of an external member and / or to each other. In some cases, an adhesive material may be used. For example, Figures 29A to 29B , Figures 30A to 30B and Figures 31A to 31D show different examples of devices using adhesives to fix the foam sub - assemblies forming the plug assembly to the outer shaft of the device. Although these examples also include distal porous drainage structures 2905', 3005' configured as wrap - around drainers and including internal members 2907, 3007, a non - wrap - around distal porous drainage structure may alternatively be used.

[0220] The adhesive material can be applied as a tape adhesive, a liquid (e.g., polymeric) adhesive, etc. In Figure 29A , the adhesives 2964, 2964' extend axially from the external elongated shaft 2903 and along a portion of the proximal and distal sides of the foam sub - assembly 2959. Figure 29B A similar example is shown where the plug assembly 2932 includes a plurality (e.g., two, or more in some examples) of foam sub - assemblies 2959 that are adhesively fixed to the shaft of the elongated outer shaft 2903, the proximal face of the innermost foam sub - assembly and the distal face of the outermost foam sub - assembly, and each foam sub - assembly is adhesively fixed to its adjacent foam sub - assembly (e.g., between the foam sub - assemblies).

[0221] In some examples, the extent of the adhesive may vary between the proximal and distal faces of the foam sub - assembly 3064 forming the plug assembly 3032. In Figure 30A , the adhesive 3064 on the proximal face extends over a greater extent (e.g., over all or most of the proximal face) than the adhesive 3064' on the distal face. In Figure 30BIn this case, the arrangement is reversed. In both cases, the adhesives 3064, 3064' fix the foam sub-assembly 3059 of the plug assembly 3032 to the outer shaft 3003.

[0222] Figures 31A to 31D End views showing different examples of adhesives attached to the end face of the foam sub-assembly (e.g., looking from the distal end face towards the proximal direction). In each example, the adhesive 3164 is attached around the shaft 3171 (e.g., the outer shaft) and to the face of the shaft 3171 (e.g., the outer shaft) and the foam sub-assembly 3159. In Figure 31A the adhesive 3164 is arranged in a single strip configuration. In Figure 31B the adhesive 3164 is arranged in a plus (+) shaped configuration. In Figure 31C the adhesive 3164 is arranged in a circular configuration with a radius smaller than that of the foam sub-assembly 3159, while in Figure 31D the adhesive 3146 has the same radius as the foam sub-assembly 3159.

[0223] As described above, any device described herein can be configured such that the distal porous drainage structure is configured to be static or non-expanding, but can additionally have the same or similar structure without the need for an internal member to extend or retract the distal porous drainage structure. Figures 32A to 32C An example of a surgical drainage device as described herein is schematically shown, where the distal porous drainage structure 3282 is formed by a turned inside-out tube of a flexible porous material (e.g., a mesh or other fabric material, including knitted, woven, and / or braided materials), the turned inside-out tube being turned on itself (e.g., from the inside to the outside). In any of these examples, it may be particularly helpful to use two or more layers of porous material (e.g., mesh) to distribute the suction within the body cavity to prevent suction locking. The turned double-layer material tube can be configured as Figure 32A shown such that both the first and second ends of the tubular material 3282 are attached to the outer shaft 3203. The devices shown herein (including Figures 32A to 32CThe size of the device (in the device) is not intended to be precise and can vary. For example, the distal porous drainage structure can extend between 1 and 15 inches or more (e.g., between 1 and 14 inches, between 1 and 13 inches, between 1 and 12 inches, between 1 and 11 inches, between 1 and 10 inches, between 1 and 9 inches, etc.). The distal porous drainage structure can generally be flexible and compressible (e.g., when inserted into the tissue area, it can be compressed downward), but generally has sufficient column strength such that it can be manually inserted into the body area without bending or collapsing. In some cases, the user can manually guide (using a gloved hand) the non-wrapping distal porous drainage structure into the body. A device including the non-wrapping distal porous drainage structure can include any of the plug assemblies described herein, and / or can include a sealing connector as described above.

[0224] For example, Figures 32A to 32C illustrates an example of a device having a non-wrapping distal porous drainage structure 3282 and a plug assembly 3232 similar to those shown and described above in Figures 27A to 27C wherein the plug assembly 3232 is formed by a plurality of foam sub-assemblies 3259 arranged along an outer shaft 3203. Similarly, Figures 33A to 33B and 34A to Figure 34B illustrates devices having non-wrapping distal porous drainage structures 3382, 3482, wherein plug assemblies 3332, 3432 are attached to outer shafts 3303, 3403, and wherein each plug assembly is formed by a plurality of shaped sub-assemblies 3359, 3459 arranged similar to those shown in Figures 27D to 27G .

[0225] Similarly, Figure 35 , Figures 36A to 36B and Figures 37A to 37B illustrate corresponding to Figure 28 , Figures 29A to 29B and Figures 30A to 30BExamples of surgical drainage devices, but with a non-wound-around distal porous drainage structure instead of a wound-around distal porous drainage structure (and thus no inner member). For example, the non-wound-around distal porous drainage structures 3582, 3682, 3782 can be formed by flipping the porous mesh tubular material onto itself at the distal face, where the ends of the mesh tube are connected to the outer shafts 3503, 3603, 3703 of the device, forming a double-layer tube. In some cases, the mesh material can be knitted, woven, and / or braided. Any of these devices can also include a plug assembly 3532, 3632, 3732, which can include one or more foam sub-assemblies 3559, 3659, 3759, and the one or more foam sub-assemblies 3559, 3659, 3759 can be adhesively fixed to the outer shaft by adhesive materials 3664, 3664', 3764, 3764'.

[0226] In some of the surgical drainage devices described herein, the distal porous drainage structure can include a distal porous drainage structure that is a wound-around drainage structure, where the inner member of the distal porous drainage structure can extend beyond the distal end of the outer elongate shaft. This can provide additional column strength when the device is deployed into a body region. For example, Figures 38A to 38C An example of a surgical drainage device is shown, where the distal porous drainage structure is formed from a tubular mesh material that is attached at one end to an outer shaft 3888, which is configured as a retractable sheath, and the opposite end region of the distal porous drainage structure is attached to a hollow tubular inner shaft member 3807, which is initially in an extended configuration such that the distal end region of the inner shaft member extends distally beyond the outer (e.g., sheath) member, as Figure 38A shown. In this example, the distal porous drainage structure can have a relatively high column strength and can be inserted into the body in this configuration. Once inserted, the outer (e.g., sheath) member 3888 can be moved distally to allow the distal porous drainage structure to expand and / or conform to the body region and form a suction passage through the distal porous drainage structure. Alternatively or additionally, the inner shaft member 3807 can be retracted proximally to form a double-layer tube of the distal porous drainage structure such that suction can be applied through the distal porous drainage structure. Figure 38B Shows the outer member 3888 being advanced distally, while Figure 38C shows the inner member being retracted proximally.

[0227] Any of the devices described herein can include a plug configured to be actively controlled (e.g., contracted and / or expanded). For example, any of the devices described herein can include a covering, such as a fluid-impermeable (fluid barrier) covering over the plug assembly. As Figures 39A to 39BAs shown, in some examples, a covering may be used to controllably compress and / or release (e.g., allow expansion of) a plug assembly. Figure 39A An apparatus is shown that includes an outer shaft 3903, a distal porous drainage structure (configured as a coiled drainer in this example, although a non - coiled drainer may be used) 3905, a hollow inner shaft 3907, and a plug assembly 4032. The plug assembly includes a foam sub - assembly, e.g., a compressible and self - expanding cylindrical / disc of foam 3959 shown as having a channel through which the outer shaft passes. The plug assembly also includes a covering 3982 that is attached distally 3958 to the outer shaft and is slidably coupled proximally 3957 to the outer shaft. As Figure 39B shown, pulling the proximal end 3957 of the covering proximally will cause the plug assembly to compress / collapse. Releasing the covering and allowing the covering to slide distally allows the plug assembly to re - expand (as Figure 39A shown).

[0228] The covering 3982 may completely or partially cover the compressible / self - expanding sub - assembly. In some examples, the covering may be one or more strips, as Figures 40A to 40B shown. In Figure 40A a surgical drainage device includes an outer shaft 4003, a distal porous drainage structure (shown as a coiled drainer, although a non - coiled drainer may be used) 3905, an inner shaft 4007, and a plug assembly 4032. As Figures 39A to 39B shown, the plug assembly includes a compressible / self - expanding foam sub - assembly 4059. In this example, multiple strips 4083, 4083’, 4083” are included as part of the plug assembly; each strip is attached distally 4058 to the outer shaft and is slidably coupled to the outer shaft at the proximal end region. As Figure 40B shown, the strip may be pulled by sliding the proximal end 4057 proximally (to the left in Figures 40A to 40B ) to place the strip under tension to collapse the plug assembly 4059. Releasing the proximal end 4057 of the strip allows the plug assembly to self - expand, as Figure 40A shown. The proximal end region of the covering (the entire covering or one or more strips) may be coupled to a ring or other slider that may be on the outer shaft to allow it to slide and / or be grasped, e.g., by a user's hand.

[0229] In some examples as described herein, the plug assembly may be configured to be removed from the body (e.g., at the end of a surgery) by collapsing with the covering and / or one or more strips. Alternatively, in some examples, the plug assembly may be removed by controllably deconstructing the plug assembly such that the plug assembly collapses downward and / or may be withdrawn from the channel. For example, Figures 41A to 41C an example of a plug assembly configured to be removed from the body by pulling a tether (e.g., a cord, thread, etc.) is shown.Figure 41A An example of a device is shown that includes an outer shaft 4103, a distal porous drainage structure 4182 (shown as a non-wrapped drain, but alternatively could be a wrapped drain), and a plug assembly 4032 formed by a compressible / self-expanding foam plug assembly 4191. A pull tether 4195 is attached to the proximal portion of the plug assembly. Pulling on the pull tether 4195 will cause the plug assembly to be removed and thus collapse. In some examples, the plug assembly is formed by a plurality of plug sub-assemblies that are connected to adjacent compressible / self-expanding foam plug assemblies at a single discrete point, as Figure 41B shown. In Figure 41B , pulling the pull tether 4195 proximally pulls the plug assembly apart such that the individual plug sub-assemblies are pulled apart, as shown. Alternatively, in some examples, the plug assembly can be formed by a helical sub-assembly 4191 that can disassemble the plug assembly as Figure 41C shown when the proximal end is pulled proximally by the pull tether 4195.

[0230] In some examples, collapse can occur by changing the configuration of the plug assembly from a protruding configuration (where one or more plug sub-assemblies protrude beyond the outer shaft) to a collapsed configuration (where the arrangement of one or more plug sub-assemblies is arranged in a lower profile). As in the variant shown in Figures 41A to 41C , the plug assembly can shrink or decrease in radial diameter without compressing the material forming the plug assembly (although the material can also be compressed).

[0231] For example, in Figures 42A to 42B , the device includes an outer shaft 4203, a distal porous drainage structure 4282 (optionally configured as a static or non-wrapped drain), and a plug assembly 4232. The plug assembly also includes a tether 4203 extending proximally. In Figure 42A , the plug assembly is shown in a radially expanded protruding configuration. The plug assembly in this example is formed of a foam material attached to the outer shaft along a first region, and the foam material is folded under itself (e.g., folded in half over itself). The tether is connected to the region that is folded under such that pulling the tether proximally causes the foam material to unfold, allowing the foam material to lie more flat against the outer side of the outer shaft, as Figure 42B shown. In some examples, the plug sub-assembly can be flipped over itself to form a protruding configuration, and pulling the tether proximally can reverse-flip the plug sub-assembly into a more flat configuration.

[0232] Any method (including user interfaces) described herein may be implemented as software, hardware, or firmware, and may be described as a non-transitory computer-readable storage medium storing a set of instructions executable by a processor (e.g., a computer, tablet, smartphone, etc.), which, when executed by the processor, causes the processor to control the execution of any steps, including but not limited to: display, communicate with the user, analyze, modify parameters (including timing, frequency, intensity, etc.), determine, alert, etc.

[0233] It should be understood that all combinations of the foregoing concepts and additional concepts discussed in more detail below (provided that these concepts are not mutually inconsistent) are considered to be part of the subject matter of the invention disclosed herein and can be used to achieve the benefits described herein.

[0234] When a feature or element is referred to herein as being "on" another feature or element, it can be directly on the other feature or element, or intervening features 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 be applied to other embodiments. Those skilled in the art will also recognize that a structure or feature referred to as being "adjacent" to another feature may have portions that overlap or are below the adjacent feature.

[0235] The terms used herein are for the purpose of describing particular embodiments only and are not intended to limit 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 should be further understood that the terms "comprises" and / or "comprising", when used in this specification, specify the presence of the 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 " / ".

[0236] For ease of description, spatially relative terms, such as "under", "below", "lower", "over", "upper", and the like, may be used herein to describe the relationship of one element or feature to another element or feature, as shown 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 the device in the figures is turned upside down, an element described as "under" or "beneath" another element or feature will then be oriented "over" the other element or feature. 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 are to be interpreted accordingly. Similarly, unless specifically stated otherwise, the terms "upwardly", "downwardly", "vertical", "horizontal", etc. are used herein for illustrative purposes.

[0237] 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 otherwise indicates. These terms may be used to distinguish one feature / element from another. Thus, without departing from the teachings of the present invention, the first feature / element discussed below may be referred to as the second feature / element, and similarly, the second feature / element discussed below may be referred to as the first feature / element.

[0238] Throughout this specification and the appended claims, unless the context requires otherwise, the term "comprise" and variations such as "comprises" and "comprising" mean that various components may be used together in methods and articles (e.g., compositions and apparatuses, including devices and methods). For example, the term "comprising" will be understood to imply the inclusion of any recited element or step, but not the exclusion of any other element or step.

[0239] Generally, any devices and methods described herein should be understood to be inclusive, but all or subsets of the components and / or steps may alternatively be exclusive and may be expressed as "consisting of various components, steps, sub-components or sub-steps" or alternatively "consisting essentially of various components, steps, sub-components or sub-steps".

[0240] As used herein in the specification and claims, including 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 "approximate" may be used when describing magnitudes and / or positions to indicate that the described value and / or position are within a reasonable expectation range of the value and / or position. For example, a numerical value can have a value of + / −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 value given herein should also be understood to include about or approximate that value, unless the context otherwise indicates. 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 should also be understood that, as would be understood by a person skilled in the art, when a value is disclosed, the possible ranges "less than or equal to" that value, "greater than or equal to" that value, and between the values are also disclosed. For example, if the value "X" is disclosed, then "less than or equal to X" and "greater than or equal to X" are also disclosed (e.g., where X is a numerical value). It should also be understood that throughout the application, data are provided in a variety of different formats, and that this data represents any combination of endpoints and starting points of data points and ranges. For example, if a particular data point "10" and a particular data point "15" are disclosed, then it should be understood that greater than, greater than or equal to, less than, less than or equal to, and equal to 10 and 15, and between 10 and 15 are considered to be disclosed. It should also be understood that each unit between two particular units is also disclosed. For example, if 10 and 15 are disclosed, then 11, 12, 13, and 14 are also disclosed.

[0241] Although various illustrative embodiments have been described above, any of several changes may be made to the various embodiments without departing from the scope of the invention described in the claims. For example, in alternative embodiments, the order in which the various described method steps are performed can generally be changed, and in other alternative embodiments, one or more method steps can be skipped altogether. Optional features of the various apparatus and system embodiments may be included in some embodiments and not included in other embodiments. Accordingly, the foregoing description has been provided primarily for exemplary purposes and should not be construed as limiting the scope of the invention as set forth in the claims.

[0242] The examples and illustrations included in this document show, by way of illustration and not limitation, specific embodiments in which the subject matter may be practiced. As mentioned, other embodiments may be utilized and derived therefrom, such that structural and logical substitutions and changes may be made without departing from the scope of the present disclosure. For convenience only, such embodiments of the inventive subject matter may be referred to herein individually or collectively by the term "invention", and are not intended to actively limit the scope of the present application to any single invention or inventive concept if more than one is actually disclosed. Thus, while specific embodiments have been illustrated and described herein, any arrangement that is recognized to achieve the same purpose may replace the specific embodiments shown. The present disclosure is intended to cover any and all modifications or variations of various embodiments. After reading the above description, those skilled in the art will appreciate the combinations of the above embodiments and other embodiments not specifically described herein.

Claims

1. A surgical drainage device, comprising: A first elongated shaft; A second elongated shaft having a suction lumen extending therethrough, wherein the second elongated shaft is configured to axially move within the first elongated shaft; A distal porous drainer extending distally from the distal end regions of the first and second elongated shafts, wherein the distal porous drainer includes two or more porous material layers surrounding a central lumen that is in fluid communication with the suction lumen; and A compressible and self-expanding plug assembly on an outer surface of the first elongated shaft.

2. The device according to claim 1, wherein, The two or more porous material layers include a mesh.

3. The device according to claim 1, wherein, The two or more porous material layers include knitted, woven, or braided materials.

4. The apparatus according to claim 1, wherein, The two or more porous material layers include a non-woven porous material sheet.

5. The apparatus according to claim 1, wherein The two or more porous material layers include an inverted mesh tube having a first end coupled to the first elongated shaft and a second end coupled to the second elongated shaft.

6. The device according to claim 1, wherein, The distal porous drainer is tubular and has two or more concentric cylindrical mesh walls.

7. The device according to claim 1, wherein, The central lumen is open at the distal end region of the distal porous drainer.

8. The apparatus according to claim 1, wherein, The distal porous drainer is a non-tubular structure.

9. The apparatus according to claim 1, wherein, The plug assembly includes an elastic body, an expandable mesh, and a fluid barrier membrane, the expandable mesh configured to radially compress the elastic body.

10. The device according to claim 1, further comprising one or more locks configured to lock the plug assembly in a radially expanded configuration, a radially compressed configuration, or both the radially expanded and radially compressed configurations.

11. The apparatus according to claim 1, wherein, The distal porous drainer is configured to be compressed along its distal-to-proximal length.

12. The device according to claim 1, further comprising a suction port at a proximal end region of the device.

13. The device according to claim 1, further comprising a suction connector having a suction port at a proximal end and a releasable connector at a distal end, wherein the releasable connector is configured to couple to the first elongated shaft.

14. The device according to claim 1, wherein, The compressible and self-expanding plug assembly includes a viscoelastic foam.

15. The device according to claim 1, wherein The distal porous drainer has a diameter greater than 2 cm in a relaxed state.

16. The device according to claim 1, wherein, The distal porous drainer is configured to extend out of or retract into the first elongated shaft when the second elongated shaft axially moves relative to the first elongated shaft.

17. The device according to claim 1, further comprising a stop that limits axial movement of the second elongated shaft relative to the first elongated shaft to prevent the second elongated shaft from extending distally out of the first elongated shaft.

18. A surgical drainage device, comprising: A first elongated shaft; A second elongated shaft having a suction lumen extending therethrough, wherein the second elongated shaft is configured to move coaxially relative to the first elongated shaft; Distal porous drain, the distal porous drain including a flip tube having a first end coupled to the distal end region of the first elongated shaft and a second end coupled to the distal end region of the second elongated shaft such that the distal porous drain includes two or more adjacent mesh layers surrounding a central lumen that is in fluid communication with the suction lumen; and A compressible and self-expanding plug assembly on the outer surface of the first elongated shaft.

19. A surgical drainage device comprising: A first elongated shaft; A second elongated shaft having a suction lumen extending therethrough; A distal porous drain extending distally from the distal end regions of the first and second elongated shafts, wherein the distal porous drain includes a mesh tube that is flipped upon itself to form adjacent cylindrical layers surrounding a central lumen that is in fluid communication with the suction lumen; and A compressible and self-expanding plug assembly on the outer surface of the first elongated shaft.

20. A method of draining a body region, the method comprising: Positioning a distal porous drain into the body region, wherein the distal porous drain extends distally from a first elongated shaft and a second elongated shaft coaxial with the first elongated shaft, and further wherein the distal porous drain includes two or more concentric flexible porous material layers surrounding a central lumen that is in fluid communication with a suction lumen extending through the first elongated shaft; Forming a seal around the first elongated shaft to maintain a vacuum within the body region; And Applying a negative pressure through the suction lumen such that a plurality of flow paths are formed through and between the two or more concentric porous material layers along the length of the distal porous drain.

21. The method according to claim 20, wherein The two or more concentric porous material layers include a mesh material.

22. The method according to claim 20, wherein, The distal porous drain is attached to the first elongated shaft at a first end and to the second elongated shaft at a second end.

23. The method of claim 20, further comprising maintaining suction when the distal porous drain is compressed by the body region.

24. The method according to claim 20, wherein, Positioning the distal porous drain in the body region includes advancing the second elongated shaft distally to extend the distal porous drain distally out of the first elongated shaft and into the body region distally of the second elongated shaft.

25. The method of claim 20, further comprising maintaining the negative pressure within the body region after withdrawing the distal porous drain from the body region.

26. The method according to claim 20, wherein, Forming the seal includes expanding a plug assembly coupled to the first elongated shaft into a body passage leading to the body region.

27. The method according to claim 26, wherein, The plug assembly is disposed around the outer surface of the first elongated shaft.

28. The method of claim 26, further comprising locking the plug assembly in a radially expanded configuration to maintain the seal.

29. The method according to claim 26, further comprising radially compressing the plug assembly before positioning the plug assembly within the body passage.

30. The method according to claim 29, wherein, Radially compressing the plug assembly includes pulling proximally on a compression layer that covers the resilient body such that the compression layer elongates and applies a radially compressive force on the resilient body.

31. The method according to claim 20, further comprising connecting the suction lumen to a suction source before applying the negative pressure.

32. The method according to claim 31, wherein, Connecting the suction lumen includes releasably coupling the first elongated shaft to a suction connector having a friction fit connector for the first elongated shaft and a suction port configured to couple to a negative pressure source.

33. A surgical drainage device, comprising: An elongated shaft having a suction lumen extending therethrough; A distal porous drain extending distally from a distal end region of the elongated shaft, wherein the distal porous drain includes two or more porous material layers surrounding a central lumen that is in fluid communication with the suction lumen; and A compressible and self-expanding plug assembly on an outer surface of the elongated shaft, wherein the plug assembly is positioned around the outer surface of the elongated shaft and includes a resilient body covered by a covering, wherein the covering is arranged to apply a radially compressive force on the resilient body to radially compress the resilient body and release the compressive force to allow the resilient body to resume a radially expanded state.

34. The apparatus according to claim 33, wherein, The covering includes a compression layer and a fluid barrier layer, the compression layer being configured to apply the compressive force.

35. The apparatus according to claim 34, wherein, The compression layer includes an expandable mesh.

36. The apparatus according to claim 33, wherein, The covering is coupled to a slidable proximal connector configured to elongate the covering when driven distally, thereby generating the radially compressive force.

37. The apparatus according to claim 36, wherein, The slidable proximal connector is configured to apply an axial compressive force on the resilient body when driven distally, thereby enhancing the resilient body in the radially expanded state.

38. The apparatus according to claim 36, wherein, The plug assembly includes a plurality of resilient bodies configured to slide axially relative to the elongated shaft, wherein the slidable proximal connector is configured to compress the plurality of resilient bodies together when driven distally.

39. The apparatus according to claim 36, wherein, The plug assembly includes an actuator configured to activate the slidable proximal connector.

40. The apparatus according to claim 36, wherein, The slidable proximal connector is configured to be activated by hand.

41. The apparatus according to claim 33, wherein, The resilient body has a flat side that is oriented at a predetermined angle relative to the outer surface of the elongated shaft when the resilient body is in the radially expanded state.

42. The device according to claim 41, wherein, The predetermined angle is approximately 90 degrees.

43. The apparatus according to claim 33, wherein, The resilient body is configured to fold radially inwardly when the radially compressive force is applied to the resilient body.

44. The device according to claim 33, wherein The covering is configured to twist relative to the elongated shaft.

45. The apparatus according to claim 44, wherein, The covering is coupled to a slidable proximal connector configured to rotate relative to the elongated shaft when driven proximally, thereby twisting the covering.

46. The apparatus according to claim 33, wherein, The elastic body is positioned at the distal end of the elongated shaft, wherein the distal porous drain is configured to extend distally away from the elongated shaft through the distal end of the elongated shaft.

47. The apparatus according to claim 33, wherein, The elastic body includes foam.

48. The apparatus according to claim 33, wherein, The plug assembly includes one or more locks configured to lock the elastic body in the radially expanded state.

49. The apparatus according to claim 48, wherein, The one or more locks are further configured to lock the elastic body in a radially compressed state.

50. The apparatus according to claim 33, wherein, When in the radially expanded state, the elastic body has a circular radial cross-section.

51. The apparatus according to claim 33, wherein, When in the radially expanded state, the elastic body has an elliptical radial cross-section.

52. The apparatus according to claim 33, wherein, When in the radially expanded state, the elastic body has a rectangular axial cross-section.

53. The apparatus according to claim 33, wherein, When in the radially expanded state, the elastic body has a circular axial cross-section.

54. The apparatus according to claim 33, wherein, When in the radially expanded state, the elastic body has an elliptical axial cross-section.

55. A method for draining a body region, the method comprising: Positioning a distal porous drain into a body region, wherein the distal porous drain extends distally from an elongated shaft, the elongated shaft having a suction lumen therethrough, and further wherein the distal porous drain includes two or more porous material layers surrounding a central lumen, the central lumen being in fluid communication with the suction lumen; Positioning a plug disposed around the elongated shaft into a body passage leading to the body region, wherein the plug includes an elastic body covered by a covering, wherein the plug is in a radially compressed state during positioning of the plug, and wherein the covering applies a radially compressive force on the elastic body; Forming a seal by expanding the plug within the body passage to maintain a vacuum within the body region, wherein expanding the plug includes releasing the radially compressive force applied by the covering on the elastic body; and Applying a negative pressure through the suction lumen such that a plurality of flow paths are formed through and between the two or more porous material layers along the length of the distal porous drain.

56. The method according to claim 55, wherein, The covering includes a fluid barrier layer forming an epidermis on a portion of the plug.

57. The method according to claim 55, further comprising placing the plug in the radially compressed state by generating the radially compressive force on the elastic body by driving a slidable proximal connector in a proximal direction to elongate the covering.

58. The method according to claim 57, wherein, The radially compressive force causes the elastic body to fold radially inward.

59. The method according to claim 57, wherein, Forming the seal includes enhancing the elastic body in the radially expanded state by driving the slidable proximal connector distally to apply an axial compressive force on the elastic body.

60. The method according to claim 59, wherein, The plug includes a plurality of elastic bodies configured to slide axially relative to the elongated shaft, wherein forming the seal includes driving the slidable proximal connector distally to compress the plurality of elastic bodies together.

61. The method according to claim 57, wherein, Driving the slidable proximal connector in the proximal direction includes activating an actuator.

62. The method according to claim 57, wherein, Driving the slidable proximal connector in the proximal direction includes pulling a handle by hand.

63. The method according to claim 55, wherein, The elastic body has a flat side surface, and when the elastic body is in a radially expanded state, the flat side surface is oriented at a predetermined angle with respect to the outer surface of the elongated axis.

64. The method according to claim 63, wherein, The predetermined angle is approximately 90 degrees.

65. The method according to claim 55, wherein, Releasing the radially compressive force applied to the elastic body includes untwisting the covering in the configured state.

66. The method according to claim 55, wherein The elastic body includes foam or sponge.

67. The method according to claim 55, wherein forming the seal includes locking the plug in a radially expanded state.

68. The method according to claim 55, further comprising locking the plug in a radially compressed state.

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