Surgical drains and methods for use

Abstract

Described herein is a surgical drain including a distal porous drain 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 drain can be configured to conform to the shape of the body region being treated.

Description

[Technical Field]

[0001] The present disclosure relates to surgical drains and methods for use.

[0002] (Priority Claim)

[0001] This patent application claims priority to U.S. Provisional Patent Application No. 63 / 424,944, entitled "SURGICAL DRAIN AND METHODS FOR USE," filed November 13, 2022, the entire contents of which are incorporated herein by reference.

[0003] (Incorporated by reference)

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

[0004]

[0003] Surgical drains are implants that allow for the removal of fluids (blood, pus, etc.) and / or gas from a wound or body cavity. This broadly includes nasogastric tubes, urinary catheters, vascular access ports, ventriculoperitoneal shunts, and negative pressure surgical drains. Negative pressure surgical drains are newer active surgical drains that are believed to offer advantages not realized by other types of surgical drains.

[0005]

[0004] Generally, surgical drains can aid in the healing process by removing inflammatory mediators, bacteria, foreign bodies, and necrotic tissue. Drains can relieve pressure that could impede perfusion or cause pain, thereby reducing morbidity and inflammation. Drains also allow for easy sampling of fluids during healing, allowing for monitoring of potential complications, and drains can be used to address complications associated with dead space. Active drains use intermittent or continuous negative pressure to draw fluid or gas from the wound or body cavity. Typically, passive drains are open systems, while active drains are closed systems, relying on the negative pressure created by the drain.

[0006]

[0005] Unfortunately, it is often difficult for negative pressure drains to provide uniform negative pressure within tissue cavities (both natural and those formed due to trauma) because the soft tissue can fold and collapse around the location(s) where pressure is applied, sealing off other areas from the pressure source. In addition, it can be difficult to remove the drain from tissue, especially in the case of damaged and healing tissue, without causing further damage and disrupting the nascent healing.

[0007]

[0006] Negative pressure drains can be particularly useful in treating postpartum uterine bleeding. Postpartum uterine bleeding can occur when the uterine muscles are unable to contract sufficiently after delivery to block the flow of blood that had previously circulated within the uteroplacental space. This lack of contraction is called atony (lack of tone). The uterine muscles typically block blood flow through muscular contractions that effectively pinch the arterial blood vessels running through the tissue. In some cases, atony can result in the arterial blood vessels continuing to bleed into the uterus (i.e., postpartum uterine bleeding). Postpartum bleeding, or excessive uterine blood loss after childbirth, is a leading cause of maternal death worldwide. Uncontrolled postpartum bleeding can force women to receive multiple blood transfusions and, in severe cases, may require a total hysterectomy. Therefore, controlling such postpartum bleeding is desirable. Current medical devices and surgical procedures have proven insufficient to reduce postpartum bleeding or blood loss and / or are highly invasive. [Prior art documents] [Patent documents]

[0008] [Patent Document 1] U.S. Provisional Patent Application No. 63 / 424,944 Summary of the Invention [Problem to be solved by the invention]

[0009]

[0007] What is needed is an easy to use negative pressure drain that can create and sustain a uniform region of negative pressure within soft tissue without disrupting tissue apposition and associated healing within soft tissue, including but not limited to the uterus, wounds, and body cavities. [Means for solving the problem]

[0010] The surgical drains and methods described herein provide negative pressure drains capable of generating and sustaining a uniform region of negative pressure within soft tissue. These apparatus (devices, systems, drains, etc.) may include one or more elongate members (e.g., tubes, catheters, and / or rods) connected to a distal multi-lumen drain (e.g., mesh). The apparatus may be configured to apply suction through the elongate member(s) and the distal multi-lumen drain. The distal multi-lumen drain is compliant and capable of distributing negative pressure (suction) within the soft tissue region being treated. The distal multi-lumen drain may include two or more layers through which suction is applied, providing multiple flow paths along the length of the distal multi-lumen drain, e.g., into and between the two or more porous layers. The distal multi-lumen drain, when positioned within a soft tissue region (e.g., a body cavity) and negative pressure is applied, can conform to the shape of the tissue and be drawn with the tissue while still maintaining a shape that allows fluid to flow through the pores of the distal multi-lumen drain and along the length of the distal multi-lumen drain (e.g., between the layers) to drain the fluid from the soft tissue region. The device may include one or more integral or separate seals (e.g., plugs) that help seal the soft tissue region so that negative pressure is maintained.

[0011] These devices may be used on any suitable tissue, particularly for soft tissue injuries where drainage and proper alignment of tissue is desirable or where negative pressure is desirable. In particular, these devices and methods of using the devices may be useful for contracting the uterus to reduce postpartum bleeding.

[0012]

[0010] The distal multi-lumen drain can be a mesh or other distal multi-lumen drain including a network of fluidly connected pores. The network of pores communicates with a vacuum source via one or more fluid pathways, for example, via one or more lumens in one or more elongate bodies connected to the distal multi-lumen drain. The distal multi-lumen drain can be deployed within the body region to be treated (e.g., the uterus) and used to distribute negative pressure (suction) from a vacuum source within the body region to be treated. For example, negative pressure can be applied through the pores of the distal multi-lumen drain to cause fluid to flow into 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 can at least partially contract the soft tissue walls surrounding the body cavity, reducing bleeding.

[0013] The distal multi-lumen drain may be adapted to obtain suction from one or more openings in the distal end region of the elongate member and / or may be adapted to obtain suction from one or more openings in the distal end region of another elongate member (e.g., a second elongate member) of the device. Because the distal multi-lumen drain includes pores configured to readily allow liquids, substances, and / or gases to pass through, the distal multi-lumen drain may help distribute the force of negative pressure within a body region (e.g., a body cavity such as the uterus). The distal multi-lumen drain may prevent localized areas of higher negative pressure that could otherwise block off portions of the body region and prevent uniform drainage.

[0014] The distal multi-port drain may be in communication with an internal drain (e.g., a vacuum port connected to a vacuum channel) so that negative pressure can be applied outward from the distal multi-port drain. This would allow the distal multi-port drain to distribute negative pressure over a larger area and / or create a larger surface area for fluid control. The porosity of the distal multi-port drain (e.g., the interfilament spacing in variations in which the distal multi-port drain is formed from knitted, woven, or braided fibers) may be controllable.

[0015]

[0013] For example, the present specification describes a surgical drain device comprising: an elongate shaft having an aspiration lumen extending therethrough; a distal multi-port drain extending distally from a distal end region of the elongate shaft, the distal multi-port drain comprising two or more layers of porous material surrounding a central lumen in fluid communication with the aspiration lumen; and a compressible self-expanding plug assembly on the outer surface of the elongate shaft.

[0016] The layer of porous material may comprise a mesh, e.g., a knitted, woven, or braided material. The layer of porous material may comprise an inverted mesh tube having a first end connected to either end of the elongate shaft. In some embodiments, the layer of porous material comprises a nonwoven porous sheet of material.

[0017] The distal multi-lumen drain may be tubular or may have two or more concentric cylindrical mesh walls. In any of these embodiments, the central lumen may be closed at the distal end region of the distal multi-lumen drain. The distal multi-lumen drain may have a non-tubular structure. For example, the distal multi-lumen drain may be formed as a pocket (flattened) or tapered (e.g., trumpet-shaped) structure.

[0018] The plug may comprise an elastic body, a deployable mesh configured to radially compress the elastic body, and a fluid barrier membrane. In some embodiments, the plug comprises one or more locks configured to lock the plug in a radially deployed configuration, a radially compressed configuration, or both the radially deployed and radially compressed configurations.

[0019]

[0017] The distal porous drain can be configured to be compressed along its distal-proximal length without impairing the distal porous drain's ability to remove substances (e.g., fluids) by maintaining multiple flow paths through and along multiple (two or more) layers of porous material.

[0020] Any of these devices may include a suction port at a proximal end region of the device. In some embodiments, these devices include a suction connector having a suction port at a proximal end and a releasable connector portion at a distal end, the releasable connector portion configured to couple to an elongate shaft.

[0021] The compressible self-expanding plug assembly may include a viscoelastic foam. The plug assembly may be self-expanding or may be manually compressible. The plug may be configured to deploy relatively slowly (e.g., over tens of seconds or minutes), allowing time for the user (therapist, doctor, nurse, technician) to position or reposition the device.

[0022] Generally, these devices may be configured to drain a relatively large area. For example, a distal multi-lumen drain may have a relaxed diameter of greater than 2 cm (e.g., 2 cm or more, 3 cm or more, 4 cm or more, 5 cm or more, 6 cm or more, 7 cm or more, 8 cm or more, 9 cm or more, 10 cm or more, etc.).

[0023]

[0021] For example, the present specification describes a surgical drain device comprising: an elongate shaft having an aspiration lumen extending therethrough; a distal multi-lumen drain extending distally from a distal end region of the elongate shaft, the distal multi-lumen drain comprising two or more adjacent layers of mesh surrounding a central lumen in fluid communication with the aspiration lumen; and a compressible self-expanding plug assembly on the outer surface of the elongate shaft.

[0024]

[0022] In some embodiments, the surgical drain device includes an elongate shaft having an aspiration lumen extending therethrough, a distal multi-lumen drain extending distally from the distal end region of the elongate shaft, the distal multi-lumen drain comprising a mesh tube inverted upon itself to form an adjacent cylindrical layer surrounding a central lumen in fluid communication with the aspiration lumen, and a compressible self-expanding plug assembly on the outer surface of the elongate shaft.

[0025]

[0023] Also described herein are methods of using any of these devices as surgical drains. For example, a method of draining a body region may include the steps of: positioning a distal multi-lumen drain within the body region, the distal multi-lumen drain extending distally from an elongate member forming a suction lumen therethrough, the distal multi-lumen drain comprising two or more layers of porous material surrounding a central lumen in fluid communication with the suction lumen; creating a seal around the elongate member to maintain a vacuum within the body region; and applying negative pressure through the suction lumen such that multiple flow paths are created along the length of the distal multi-lumen drain and through and between the two or more layers of porous material.

[0026]

[0024] The two or more layers of porous material may comprise a mesh material. The two or more layers of porous material may be attached to the same elongate member.

[0027] Any of these methods may include maintaining suction as the distal multi-lumen drain is compressed by the body region. Any of these methods may include maintaining negative pressure within the body region after retracting the distal multi-lumen drain from the body region.

[0028] In any of these methods, creating a seal may include deploying a plug assembly coupled to an elongate member into a body passageway leading to the body region. The plug may be disposed about an outer surface of the first elongate member. Any of these methods may include locking the plug in a radially deployed configuration to maintain the seal. Any of these methods may include radially compressing the plug prior to positioning the plug in the body passageway. For example, radially compressing the plug may include pulling a compression layer covering the elastomeric body in a proximal direction, such that the compression layer is stretched and applies a radial compression force to the elastomeric body.

[0029] Any of these methods may include connecting the suction lumen of the device to a suction source prior to the step of applying negative pressure. A method that may include the step of connecting the suction lumen comprises releasably connecting the elongate member to a suction connector having a friction fit connector portion for the elongate member and a suction port configured to connect to the negative pressure source.

[0030] Also described herein is a surgical drain device including a plug assembly configured for ease of use and effective sealing. For example, the surgical drain device may include an elongate member having an aspiration lumen extending therethrough, a distal multi-lumen drain extending distally from a distal end region of the elongate shaft, the distal multi-lumen drain including two or more layers of porous material surrounding a central lumen in fluid communication with the aspiration lumen, and a compressible, self-expanding plug assembly on the outer surface of the elongate outer shaft, the plug assembly being disposed about the outer surface of the first elongate member and including an elastomer body covered by a cover, the cover being arranged to apply a radial compressive force to the elastomer body to radially compress it and release the compressive force to allow the elastomer body to regain its radially expanded state.

[0031] The cover may include a compression layer and a fluid barrier layer, the compression layer configured to apply a compression force. In some embodiments, the compression layer includes an expandable mesh. The cover may be coupled to a slidable proximal connector configured to stretch the cover when actuated distally, thereby generating a radial compression force. The slidable proximal connector may be configured to apply an axial compression force to the elastic bodies when actuated distally, thereby stiffening the elastic bodies in a radially expanded state. The plug assembly may include a plurality of elastic bodies configured to slide axially relative to the first elongate member, wherein the slidable proximal connector is configured to compress the plurality of elastic bodies together when actuated distally. The plug assembly may include an actuator configured to activate the slidable proximal connector. The slidable proximal connector may be configured to be manually activated.

[0032] In some embodiments, the elastic body has flat sides that are oriented at a predetermined angle relative to the outer surface of the first elongate member when the elastic body is in a radially deployed state. The predetermined angle may be approximately 90 degrees. The elastic body may be configured to fold radially inward when a radial compressive force is applied to the elastic body. The cover may be configured to twist relative to the first elongate member. The cover may be coupled to a slidable proximal connector configured to rotate relative to the first elongate member when driven proximally, thereby twisting the cover. The elastic body may be disposed at a distal end of the first elongate member, wherein the distal multi-lumen drain is configured to distally exit the first elongate member through the distal end of the first elongate member. In some embodiments, the elastic body comprises foam. The plug assembly may include one or more locks configured to lock the elastic body in a radially deployed state. The one or more locks may be further configured to lock the elastic body in a radially compressed state. The elastic body may have a round radial cross-section when in the radially deployed state. The elastic body may have an oval radial cross-section when in the radially deployed state. The elastic body may have a rectangular axial cross-section when in the radially deployed state. In some embodiments, the elastic body has a round axial cross-section when in the radially deployed state. The elastic body may have an oval axial cross-section when in the radially deployed state.

[0033] A method of draining a body region may include the steps of: positioning a distal multi-lumen drain within the body region, the distal multi-lumen drain extending distally from an elongate member defining a suction lumen therethrough, the distal multi-lumen drain further comprising two or more layers of porous material surrounding a central lumen in fluid communication with the suction lumen; and positioning a plug disposed about a first elongate member within a body flow path leading to the body region, the plug including an elastic body covered by a cover, and a pressure sensitive adhesive layer to position the plug. The method may include positioning the plug into the body flow passage, during which the plug is in a radially compressed state with the cover exerting a radial compressive force on the elastomeric body; creating a seal that maintains a vacuum within the body region by deploying the plug within the body flow passage, wherein deploying the plug comprises releasing the radial compressive force exerted by the cover on the elastomeric body; and applying negative pressure through the suction lumen such that multiple flow paths are created through and between two or more layers of porous material along the length of the distal porous drain.

[0034]

[0032] In some embodiments described herein, the surgical drain device comprises: a first elongate member having a lumen; a second elongate member slidably disposed within the lumen of the first elongate member; a distal multi-lumen drain having a proximal end connected to a distal end region of the second elongate member and a distal end extending freely from the second elongate member, the distal multi-lumen drain comprising a network of interconnected pores; and a vacuum channel extending proximally from the distal multi-lumen drain and in fluid communication with the network of interconnected pores.

[0035] The distal multi-port drain may be a tube having a porous wall. The porous wall may terminate at the distal end of the distal multi-port drain. The distal multi-port drain may have a non-tubular structure. The device may further include a plug disposed about the first elongate member, where the plug is configured to deploy radially outward to fluidically seal the distal multi-port drain within the soft tissue cavity against the soft tissue. The plug may include an elastic body, a deployable mesh configured to radially compress the elastic body, and a fluid barrier membrane. The plug may include one or more locks configured to lock the plug in a radially deployed configuration, a radially compressed configuration, or both the radially deployed and radially compressed configurations. The distal multi-port drain may be configured to allow fluid to flow out of the body cavity through the network of interconnected pores and via the vacuum channel. The vacuum channel may be within the lumen of the first elongate member, within the second lumen of the second elongate member, or within the lumen of the first elongate member and the second lumen of the second elongate member. The vacuum channel may be operably connected to a port at a proximal end region of the device. The device may further comprise one or more seals between the first elongate member and the second elongate member. The device may further comprise one or more locks configured to lock the relative positions of the first elongate member and the second elongate member.

[0036]

[0034] Also described herein is a method of draining a body region comprising the steps of: positioning a distal multi-lumen drain within the body region, the distal multi-lumen drain having a proximal end connected to a distal end region of a second elongate member and a distal end extending freely from the second elongate member, the distal multi-lumen drain comprising a network of interconnected pores, and positioning the distal multi-lumen drain comprising advancing the second elongate member distally within the lumen of the first elongate member; positioning the distal multi-lumen drain within the body region; creating a seal to maintain a vacuum within the body region; and applying negative pressure within the body region by applying suction proximally through the network of interconnected pores.

[0037] The distal multi-lumen drain may be a tube having a porous wall. The porous wall may terminate at a distal end of the distal multi-lumen drain. The distal multi-lumen drain may have a non-tubular structure. The method may further include retracting the second elongate member proximally to draw the distal multi-lumen drain into the lumen of the first elongate member. The method may further include maintaining negative pressure within the body region after retracting the distal multi-lumen drain from the body region. Positioning the distal multi-lumen drain within the body region may deploy the distal multi-lumen drain. Creating a seal may include deploying a plug within a body passageway 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 deployed configuration to maintain the seal. The method may further include radially compressing the plug prior to positioning the plug within the body passageway. The step of radially compressing the plug may include pulling a compressible layer covering the elastic body in a proximal direction such that the compressible layer is stretched and applies a radial compressive force to the elastic body. The method may further include locking the plug in the radially compressed state.

[0038] Any of the devices may include one elongate member or multiple elongate members (e.g., two, three, four, five, or more elongate members). In some cases, the elongate members may be nested (e.g., concentrically arranged) and translatable (e.g., slidable) relative to one another. For example, a distal multi-lumen drain and / or plug may be coupled to a first (e.g., inner) elongate member that is slidably disposed within a lumen of a second (e.g., outer) elongate member. To advance and / or deploy the distal multi-lumen drain and / or plug, 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). Similarly, to retract and / or collapse the distal multi-lumen drain and / or plug, 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.) Such pulling and pushing steps may be actuated by manually grasping the first and / or second elongate members and sliding them relative to one another, or may be actuated by one or more actuators on the handle of the device.

[0039] In some embodiments, the elongate member comprises a flexible and / or curved tube. For example, the elongate member may have a bendable or curved polymer shaft to navigate bends in the anatomy. In some embodiments, the elongate member is pre-curved or pre-bent in one or more regions along its length. In some embodiments, the elongate member is steerable over all or a portion of its length. For example, the elongate member may include one or more tendons to enable steering. The elongate member may be of any suitable length. For example, the elongate member may be about 10 to 100 cm (e.g., about 15 to 80 cm, about 20 to about 50 cm, etc.). The elongate member may be formed from a polymeric material and / or a metallic material.

[0040] Any of the distal multi-lumen drains described herein may include a mesh that is a knitted, woven, or braided material. In some embodiments, the distal multi-lumen drain is a nonwoven material (e.g., a sheet or layer of polymeric material) with pores large enough to allow the passage of fluid and biological debris (e.g., pus, clots, etc.) without significant resistance. In some embodiments, the distal multi-lumen drain is a fabric. The distal multi-lumen drain may be formed from multiple filaments (e.g., strands) of material, such as monofilament or multifilament. For example, the distal multi-lumen drain may include a braided polymer monofilament having 24 or more strands (e.g., 30 or more strands, 34 or more strands, 36 or more strands, 38 or more strands, 40 or more strands, 42 or more strands, etc.).

[0041] The distal multi-lumen drain may be adapted to deploy to the deployed configuration as described. In some embodiments, the distal multi-lumen drain is biased to deploy to the deployed configuration. For example, the distal multi-lumen drain may be formed from a shape-memory material (e.g., nitinol, etc.) that can be shape-set in the deployed configuration in which the distal multi-lumen drain is deployed away from the second elongate member and / or the first elongate member.

[0042] In some embodiments, the distal multi-lumen drain has a tubular shape, and the device is configured to invert the tubular distal multi-lumen drain. One end of the invertible tubular distal multi-lumen drain may be connected to a first elongate member (e.g., a tube), and the opposite end of the invertible tubular multi-lumen drain may be connected to a second elongate member (e.g., an inner tube or rod). The second elongate member may be sized and shaped to fit within the lumen of the first elongate member. The invertible tubular distal multi-lumen drain may be deployed within the body region by pushing the second elongate member. In some cases, the second elongate member may be positioned within the first elongate member when the tubular distal multi-lumen drain is extended into the body region, thereby causing the tubular distal multi-lumen drain to assume a double-walled tubular shape. The invertible tubular distal multi-lumen drain can be removed from the body region by pulling on the second elongate member to invert the tubular distal multi-lumen drain and pull it completely back into the first elongate member.

[0043] For example, described herein is a surgical drain device comprising: a first elongate member having a lumen; a second elongate member slidably disposed within the lumen; and a reversible tubular distal multi-lumen drain having a first end connected at the first end to a distal end region of the first elongate member and a second end connected to a distal region of the second elongate member, the reversible tubular distal multi-lumen drain comprising a network of interconnected pores; A surgical drain device is described that includes an invertible tubular distal multi-lumen drain, wherein the invertible tubular distal multi-lumen drain has a double-walled tubular configuration and a second elongate member has a deployed configuration in which the second elongate member is fully retracted distally into the lumen of the first elongate member, and the invertible tubular distal multi-lumen drain has a retracted configuration in which the invertible tubular distal multi-lumen drain is inverted and retracted into the lumen of the first elongate member, and a vacuum channel extending proximally from the invertible tubular distal multi-lumen drain and in fluid communication with a network of interconnected pores.

[0044] The axial position of the first elongate member may be configured to be locked relative to the second elongate member to lock the invertible tubular distal multi-lumen drain in a double-walled tubular configuration with the second elongate member fully retracted distally into the lumen of the first elongate member. The axial position of the first elongate member may be configured to be locked relative to the second elongate member to lock the invertible tubular distal multi-lumen drain in a retracted configuration. The device may further include a plug disposed about the first elongate member, where the plug is configured to deploy radially outward to fluidically seal the distal multi-lumen drain against the soft tissue within the soft tissue cavity. The plug may include an elastic body, a deployable mesh configured to radially compress the elastic body, and a fluid barrier membrane. The plug may include one or more locks configured to lock the plug in a radially deployed configuration, a radially compressed configuration, or both the radially deployed and radially compressed configurations. The deployable mesh and fluid barrier membrane may be coupled to a slidable proximal connector configured to stretch the deployable mesh when actuated proximally, thereby generating a radial compressive force on the elastic bodies. The slidable proximal connector may be configured to apply an axial compressive force to the elastic bodies when actuated distally, thereby stiffening the elastic bodies in their radially deployed state. The plug assembly may include a plurality of elastic bodies configured to slide axially relative to the first elongate member, wherein the slidable proximal connector is configured to compress the plurality of elastic bodies together when actuated distally.

[0045]

[0043] Also described herein is a method of draining a body region comprising the steps of: positioning within the body region a reversible tubular distal multi-lumen drain comprising a network of interconnected pores, the reversible tubular distal multi-lumen drain having a first end connected at the first end to a distal end region of a first elongate member and a second end connected to a distal region of a second elongate member, wherein when the reversible tubular distal multi-lumen drain is positioned within the body region, the reversible tubular distal multi-lumen drain is in a double-walled configuration and the second elongate member is distally fully retracted within the lumen of the first elongate member; creating a seal to maintain a vacuum within the body region; and applying negative pressure within the body region by applying suction proximally through the network of interconnected pores.

[0046] Positioning the invertible tubular distal multi-lumen drain within the body region may include distally advancing the second elongate member to extend a second end of the invertible tubular distal multi-lumen 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 invertible tubular distal multi-lumen drain folds over to form a double-walled tubular configuration. Positioning the invertible tubular distal multi-lumen drain within the body region may cause the invertible tubular distal multi-lumen drain to bend laterally when it contacts a tissue wall. The double-walled tubular configuration can define a central lumen within the invertible tubular distal multi-lumen drain, and applying suction proximally causes fluid from the body region to flow into the central lumen of the invertible tubular distal multi-lumen drain. To maximize the length of the invertible tubular distal multi-lumen drain in the double-walled tubular configuration extending distally from the first elongate member, the distal end of the second elongate member can be positioned axially proximal to the distal end of the first elongate member. Applying negative pressure can include applying suction from the distal end of the first elongate member, or from one or more openings in the second elongate member, or from the distal end of the first elongate member and one or more openings in the second elongate member. Creating a seal can include deploying a plug disposed around the first elongate member within the body passageway leading to the body region. The plug may include an elastic body covered by a cover, wherein during the step of positioning the plug within the body flow passage, the plug is in a radially compressed state with the cover exerting a radial compressive force on the elastic body, and wherein deploying the plug comprises releasing the radial compressive force exerted by the cover on the elastic body. The method may further comprise the step of retracting the second elongate member proximally to draw the invertible tubular distal multi-lumen drain into the lumen of the first elongate member, thereby inverting the invertible distal multi-lumen drain.The method may further comprise maintaining negative pressure within the body region for a period of time after drawing the reversible tubular distal multi-lumen drain into the lumen of the first elongate member.

[0047] The second elongate member may be formed as a solid member (e.g., a bar, rod, wire, etc.) or may be hollow (e.g., a catheter, tube, etc.). The second elongate member may be a polymeric material and / or a metallic material such as stainless steel, nitinol, etc. The second elongate member may be flexible and / or bent (e.g., pre-bent or pre-curved) along all or a portion of its length. Because the second elongate member is slidably disposed within the first elongate member, the second elongate member typically has an outer diameter (OD) that is smaller than the inner diameter (ID) of the first elongate member. The movement of the second elongate member within the first elongate member may be limited and / or may include one or more (e.g., multiple) “stop” positions that releasably maintain the relative positions of the second elongate member and the first elongate member. For example, the stopper may be configured to maintain the position of the second elongate member such that the second elongate member remains fully retracted within the first elongate member and the reversible tubular distal multi-lumen drain has a double-wall configuration.

[0048] Any of the devices may include one or more deployable / contractable plugs (also called occluders), which may be integrated with other portion(s) of the device (e.g., elongate member) or separate from and configured to engage with other portions of the device. The plugs may form a seal between the device and the wall of a body region (e.g., a conduit, channel, or incision) so that the distal multi-lumen drain is sealed within the body cavity being treated and so that negative pressure can be applied to drain and / or collapse the body cavity. The plugs may be radially deployable and collapsible so that they can be inserted into the body region in a collapsed state and deployed within the body region to occlude the body cavity and block access to the body cavity. In some embodiments, the plugs may include a compressible porous material covered by a membrane or sheath (e.g., a compliant layer) that applies against body tissue and assists in creating a seal. In some embodiments, the occluders may include one or more balloons. The plug may have a channel or lumen that allows movement of other components of the device through the plug without disrupting the seal, hi some embodiments, the plug may surround an outer portion of the elongate member to allow suction to be applied through the lumen of the elongate member.

[0049]

[0047] For example, the present specification describes a surgical drain comprising: a first elongate member having a lumen; a second elongate member slidably disposed within the lumen of the first elongate member; a distal multi-lumen drain having a proximal end connected to a distal end region of the second elongate member, the distal multi-lumen drain comprising a network of interconnected pores; a vacuum channel extending proximally from the distal multi-lumen drain and in fluid communication with the network of interconnected pores; and a plug assembly disposed about an outer surface of the first elongate member, the plug assembly comprising an elastomer covered by a cover, the cover arranged to apply a radial compressive force to the elastomer to radially compress the elastomer and to release the compressive force to allow the elastomer to regain its radially expanded state.

[0050] The cover may include a compression layer and a fluid barrier layer, the compression layer configured to apply a compression force. The compression layer may comprise an expandable mesh. The cover may be coupled to a slidable proximal connector configured to stretch the cover when actuated distally, thereby generating a radial compression force. The slidable proximal connector may be configured to apply an axial compression force to the elastic bodies when actuated distally, thereby stiffening the elastic bodies in a radially deployed state. The plug assembly may include a plurality of elastic bodies configured to slide axially relative to the first elongate member, wherein the slidable proximal connector is configured to compress the plurality of elastic bodies together when actuated distally. The plug assembly may include an actuator configured to activate the slidable proximal connector. The slidable proximal connector may be configured to be manually activated. The elastic bodies may have flat sides oriented at a predetermined angle relative to the outer surface of the first elongate member when the elastic bodies are in a radially deployed state. The predetermined angle may be approximately 90 degrees. The elastic body may be configured to fold radially inward when a radial compressive force is applied to the elastic body. The cover may be configured to twist relative to the first elongate member. The cover may be coupled to a slidable proximal connector configured to rotate relative to the first elongate member when driven proximally, thereby twisting the cover. The elastic body may be disposed at a distal end of the first elongate member, where the distal multi-lumen drain is configured to distally exit the first elongate member through the distal end of the first elongate member. The elastic body may comprise foam or sponge. The plug assembly may include one or more locks configured to lock the elastic body in a radially deployed state. The one or more locks may be further configured to lock the elastic body in a radially compressed state. The elastic body may have a round radial cross-section when in the radially deployed state. The elastic body may have an oval radial cross-section when in the radially deployed state. The elastic body may have a rectangular axial cross-section when in the radially deployed state.The elastic body may have a round axial cross-section when in the radially deployed state. The elastic body may have an oval axial cross-section when in the radially deployed state.

[0051]

[0049] Described herein is a method of draining a body region comprising the steps of: positioning a distal multi-lumen drain into the body region by distally advancing a second elongate member connected to the distal multi-lumen drain within the lumen of the first elongate member, the distal multi-lumen drain comprising a network of interconnected pores; and positioning a plug disposed about the first elongate member into a body flow path leading to the body region, the plug being an elastic plug covered by a covering. The method includes the steps of: positioning a plug, the plug being in a radially compressed state with the cover exerting a radial compressive force on the elastomeric body during the step of positioning the plug; creating a seal that maintains a vacuum within the body region by deploying the plug within the body flow passage, the step of deploying the plug comprising releasing the radial compressive force exerted by the cover on the elastomeric body; and applying negative pressure within the body region by applying suction in a proximal direction through a network of interconnected pores.

[0052] The cover may comprise a compression layer and a fluid barrier layer, the compression layer configured to apply a compression force. The compression layer may comprise a deployable mesh. The method may further comprise placing the plug in a radially compressed state by proximally driving the slidable proximal connector to stretch the cover, thereby generating a radially compressive force on the elastomeric body. The radially compressive force may cause the elastomeric body to fold radially inward. Creating a seal may comprise reinforcing the elastomeric body in the radially deployed state by distally driving the slidable proximal connector to apply an axial compressive force to the elastomeric body. The plug assembly may comprise a plurality of elastomeric bodies configured to slide axially relative to the first elongate member, in which case creating a seal comprises distally driving the slidable proximal connector to compress the plurality of elastomeric bodies together. Driving the slidable proximal connector proximally may comprise activating an actuator. Driving the slidable proximal connector proximally may comprise manually pulling a handle. The elastic body may have flat sides oriented at a predetermined angle relative to the outer surface of the first elongate member when the elastic body is in the radially deployed state. The predetermined angle may be approximately 90 degrees. Releasing the radial compression force on the elastic body may include untwisting the configured cover. The elastic body may be disposed at a distal end of the first elongate member, in which case 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 elastic body may comprise foam or sponge. Creating a seal includes locking the plug in the radially deployed state. The method may further include locking the plug in the radially compressed state.

[0053] In some embodiments, the device may be configured to operate passively. For example, the distal multi-lumen drain and / or plug may be configured to passively deploy when placed within a body region and passively collapse when removed from the body region (e.g., without activation). In other embodiments, the distal multi-lumen drain and / or plug may be deployed and / or collapsed by activation of one or more actuators. The actuator(s) may be on a region of the device that is outside the body cavity, such as, for example, one or more handles of the device. The actuator(s) may be actuated by sliding, pulling, pushing, and / or applying pressure (e.g., by a user's hand).

[0054] Distal multi-lumen drains typically have pores that can be large enough to allow fluid and some solid biological debris (e.g., clots, pus, coagulation) to pass easily. For example, the pores may 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 may be formed by spaces between strands, for example, in woven, braided, and / or knitted porous meshes. Any of the distal multi-lumen drains may be self-expanding (e.g., formed from materials such as nitinol, polymer-blended nitinol, etc.).

[0055] Any of these devices may be coated with one or more materials to enhance their biological effectiveness. For example, these devices may be coated with procoagulant substances such as aprotinin, tranexamic acid (TXA), epsilon-aminocaproic acid, and aminomethylbenzoic acid. For example, any of the distal multi-port drains described herein may include a procoagulant material.

[0056] Any of the devices may include one or more seals between the first and second elongate members. The seals may be configured (e.g., molded, positioned, or made of a suitable material) to allow the second elongate member to slide within the lumen of the first elongate member without significant sliding force. For example, the seals may be O-rings (or O-rings), which may or may not be lubricated.

[0057] As stated, the device (e.g., system) may be configured to maintain the relative position of the first elongate member and the second elongate member. This may be accomplished by a locking mechanism, such as a lock configured to secure (e.g., removably secure) the relative position of the first elongate member and the second elongate member. The lock may cause the relative position to be maintained until additional force is applied to overcome the retaining force. For example, the lock may be a ratchet element on the proximal end of the device (e.g., on or part of a handle at the proximal end).

[0058]

[0056] Further described herein are methods of removing material (e.g., fluid) from a body region and / or contracting a body region using any of the devices described herein. These methods may be methods of draining a body region and / or contracting a body region. These methods may be methods of reducing bleeding. Any suitable body region may be treated as described. For example, the body region may be a uterus and the method may be a method of contracting the uterus to reduce bleeding. The body region may be a wound and the method may be a method of draining the wound and / or reducing bleeding and / or enhancing healing by enhancing healing. For example, these methods and devices may be used following breast surgery and for treating (e.g., draining) chest wounds, hernias, and the like.

[0059] In some cases, the distal multi-lumen drain is deployed within the body region. In any of the devices described herein, the distal multi-lumen drain may be flexible and malleable, for example, when deployed. Any of the methods may include aligning the distal multi-lumen drain within the body region to be treated, which may include flattening the distal multi-lumen drain.

[0060]

[0058] In any of the methods described herein, creating a seal may include deploying a plug positioned in a proximal region of the elongate member.

[0061] Applying negative pressure may comprise applying suction from the distal ends of the elongate members. In some embodiments, applying negative pressure comprises applying suction through one or more openings through a sidewall of the distal end region of the second elongate member.

[0062] Generally, these methods may include dissipating the force of the vacuum by applying negative pressure from a distal multi-lumen drain to compress the body region.

[0063] As mentioned, the distal multi-lumen drain can help distribute the force of the negative pressure. During application of negative pressure (or in some cases after the desired amount of negative pressure has been applied), the distal multi-lumen drain may be retracted while leaving the device in place, including (in some embodiments) a plug that maintains the negative pressure.

[0064] The negative pressure in the body region may be maintained for any suitable period of time for treatment. For example, the negative pressure may be maintained for 1 minute or more (e.g., 2 minutes or more, 5 minutes or more, 10 minutes or more, 15 minutes or more, 20 minutes or more, 25 minutes or more, 30 minutes or more, 45 minutes or more, 1 hour or more, 1.5 hours or more, 2 hours or more, 3 hours or more, 4 hours or more, 5 hours or more, 6 hours or more, 7 hours or more, 8 hours or more, etc.).

[0065]

[0063] In either of these methods, the distal end of the distal multi-lumen drain can be positioned within the tissue to be treated, for example, within the uterus.

[0066]

[0064] For example, the present specification describes a surgical drain device comprising: a first elongate shaft; a second elongate shaft having an aspiration lumen extending therethrough, the second elongate shaft being configured for axial movement within the first elongate shaft; a distal porous drain extending distally from distal end regions of the first and second elongate shafts, the distal porous drain comprising two or more layers of porous material surrounding a central lumen in fluid communication with the aspiration lumen; and a compressible self-expanding plug assembly on the outer surface of the first elongate shaft.

[0067] In the device of claim 1, the two or more layers of porous material may comprise a mesh. In some embodiments, the two or more layers of porous material may comprise a knitted, woven, or braided material. The two or more layers of porous material may comprise a nonwoven porous sheet of material. The two or more layers of porous material may comprise an everted mesh tube having a first end connected to the first elongate shaft and a second end connected to the second elongate shaft.

[0068] The distal multi-lumen drain may be tubular and may have two or more concentric cylindrical mesh walls. A central lumen may open to the distal end region of the distal multi-lumen drain. The distal multi-lumen drain may also be of non-tubular construction.

[0069] The plug assembly may include an elastomeric body, an expandable mesh configured to radially compress the elastomeric body, and a fluid barrier membrane. The elastomeric body may be a foam material. For example, a compressible self-expanding plug assembly may include a viscoelastic foam. Generally, the elastomeric body may be compressed and self-expand back to its uncompressed configuration.

[0070] Any of these devices may include one or more locks configured to lock the plug assembly in a radially deployed configuration, a radially compressed configuration, or both a radially deployed configuration and a radially compressed configuration. The distal multi-lumen drain may be configured to be compressed along its distal-proximal length. Any of these devices may include an aspiration port at a proximal end region of the device. Any of these devices may include an aspiration connector having an aspiration port at its proximal end and a releasable connector portion at its distal end, where the releasable connector portion is configured to couple to the first elongate shaft.

[0071] The distal multi-lumen drain may have a diameter greater than 2 cm in a relaxed state. In any of these devices, the distal multi-lumen drain may be configured to extend out from and retract into the first elongate shaft as the second elongate shaft is moved axially relative to the first elongate shaft. Any of these devices may include a stop (e.g., a rim, ridge, catch, detent, etc.) that limits axial movement of the second elongate shaft relative to the first elongate shaft to prevent the second elongate shaft from extending distally out from the first elongate shaft.

[0072]

[0070] For example, a surgical drain device may include: a first elongate shaft; a second elongate shaft having an aspiration lumen extending therethrough, the second elongate shaft configured for coaxial movement relative to the first elongate shaft; a distal multi-lumen drain comprising an evertable tube having a first end connected to a distal end region of the first elongate shaft and a second end connected to a distal end region of the second elongate shaft so as to have two or more adjacent layers of mesh surrounding a central lumen in fluid communication with the aspiration lumen; and a compressible self-expanding plug assembly on an outer surface of the first elongate shaft.

[0073]

[0071] In some embodiments, the surgical drain device includes: a first elongate shaft; a second elongate shaft having an aspiration lumen extending therethrough; a distal multi-lumen drain extending distally from the distal end regions of the first elongate shaft and the second elongate shaft, the distal multi-lumen drain comprising a mesh tube inverted upon itself to form an adjacent cylindrical layer surrounding a central lumen in fluid communication with the aspiration lumen; and a compressible self-expanding plug assembly on the outer surface of the first elongate shaft.

[0074] As noted above, methods of draining a body region are also described herein. For example, the method may include the steps of: positioning a distal multi-lumen drain within the body region, the distal multi-lumen drain extending distally from a first elongate shaft and a second elongate shaft coaxial with the first elongate shaft, the distal multi-lumen drain comprising two or more concentric layers of flexible porous material surrounding a central lumen in fluid communication with a suction lumen extending through the first elongate shaft; creating a seal around the first elongate shaft to maintain a vacuum within the body region; and applying negative pressure through the suction lumen such that multiple flow paths are created along the length of the distal multi-lumen drain and through and between the two or more concentric layers of porous material.

[0075] The two or more concentric layers of porous material may comprise a mesh material. The distal porous drain may have a first end attached to the first elongate shaft and a second end attached to the second elongate shaft.

[0076] Any of these methods may include the step of maintaining suction as the distal multi-lumen drain is compressed by the body region.

[0077]

[0075] In some cases, the step of positioning the distal multi-lumen drain within the body region may include the step of distally advancing the second elongate member to extend the distal multi-lumen drain distally out of the first elongate shaft and distally up the second elongate shaft into the body region.

[0078] Any of these methods may include maintaining negative pressure within the body region after retracting the distal multi-lumen drain from the body region. Creating a seal may include deploying a plug assembly coupled to the first elongate shaft into a body passageway leading to the body region. The plug assembly may be disposed about an outer surface of the first elongate shaft. Any of these methods may include locking the plug assembly in a radially deployed configuration to maintain the seal. Any of these methods may include radially compressing the plug assembly prior to positioning the plug assembly within the body passageway. Radially compressing the plug assembly may include pulling a compression layer covering the elastomeric body in a proximal direction, such that the compression layer is stretched and applies a radial compression force to the elastomeric body. Any of these methods may include connecting the suction lumen to a suction source prior to applying negative pressure.

[0079]

[0077] The step of connecting the suction lumen may include the step of releasably connecting the first elongated shaft to a suction connector having a friction fit connector portion for the first elongated shaft and an suction port configured to connect to a negative pressure source.

[0080]

[0078] All of the methods and devices described herein, in any combination, are contemplated herein and can be used to achieve the benefits described herein. [Effects of the Invention]

[0081] A better understanding of the features and advantages of the methods and apparatus described herein will be obtained by reference to the following detailed description and accompanying drawings that set forth illustrative embodiments. [Brief explanation of the drawings]

[0082] [Figure 1A] 1A is a schematic depiction of one embodiment of a surgical drain device described herein, including a two-layer distal multi-lumen drain. [Figure 1B] 1B shows a cross-section through the device of FIG. 1A. [Figure 1C] 1C-1F illustrate the exemplary device of FIGS. 1A-1B treating a tissue region, depicting a cross-sectional top view of the body region. [Figure 1D] The same body region as in Figure 1C is depicted in cross-sectional side view. [Figure 1E] The device of FIGS. 1A-1B is shown inserted into the body region of FIGS. 1C and 1D, with a view through the same body region as FIG. 1C. [Figure 1F] FIG. 1E shows the device of FIGS. 1A-1B in a view through the same body region as FIG. 1D, illustrating compression of the flexible distal multi-lumen drain without vacuum lock. [Figure 2A] 10A-10C depict side views of an example device with a different tubular distal multi-lumen drain. [Figure 2B] 10A-10C depict side views of an example device with a different tubular distal multi-lumen drain. [Figure 2C] 10A-10C depict side views of an example device with a different tubular distal multi-lumen drain. [Figure 2D] 10A-10C depict side views of an example device with a different tubular distal multi-lumen drain. [Figure 2E] 10A-10C depict side views of an example device with a different tubular distal multi-lumen drain. [Figure 3A1] 1 depicts a distal end view of an exemplary device having a tubular distal multi-lumen drain. [Figure 3A2] 3A depicts a side view of the device of FIG. 3A1. [Figure 3B1] 1 depicts a distal end view of an exemplary device having a tubular distal multi-lumen drain. [Figure 3B2] 3B illustrates a side view of the device of FIG. 3B1. [Figure 3C1] 1 depicts a distal end view of an exemplary device having a tubular distal multi-lumen drain. [Figure 3C2] 3C1 depicts a side view of the device of FIG. 3C1. [Figure 3D1] 1 depicts a distal end view of an exemplary device having a tubular distal multi-lumen drain. [Figure 3D2] 3D1 depicts a side view of the device of FIG. 3D1. [Figure 3E1] 1 depicts a distal end view of an exemplary device having a tubular distal multi-lumen drain. [Figure 3E2] 3E2 depicts a side view of the device of FIG. 3E1. [Figure 4A1] 10A-10C depict distal end views of an example device having a different distal multi-port drain. [Figure 4A2] 4A depicts a side view of the device of FIG. 4A1. [Figure 4B1] 10A-10C depict distal end views of an example device having a different distal multi-port drain. [Figure 4B2] 4B1 depicts a side view of the device of FIG. 4B1. [Figure 4C1] 10A-10C depict distal end views of an example device having a different distal multi-port drain. [Figure 4C2] 4C1 depicts a side view of the device of FIG. 4C1. [Figure 4D1] 10A-10C depict distal end views of an example device having a different distal multi-port drain. [Figure 4D2] 4D1 depicts a side view of the device of FIG. 4D1. [Figure 4E1] 10A-10C depict distal end views of an example device having a different distal multi-port drain. [Figure 4E2] 4E1 depicts a side view of the device of FIG. 4E1. [Figure 5A1] 10 illustrates one example of how a device having a tubular distal multi-lumen drain can provide a fluid path for withdrawing fluids and / or gases. [Figure 5A2] 5A1 together illustrate an example of how a device having a tubular distal multi-lumen drain can provide a fluid path for withdrawing fluids and / or gases. [Figure 5A3]5A1-5A2, together depict an example of how a device having a tubular distal multi-lumen drain can provide a fluid path for withdrawing fluids and / or gases. [Figure 5A4] 5A1-5A3 together illustrate an example of how a device having a tubular distal multi-lumen drain can provide a fluid path for withdrawing fluids and / or gases. [Figure 6A] 1 depicts a partially see-through side view of an example device including a reversible tubular distal multi-lumen drain. [Figure 6B] 6A illustrates a partially transparent side view of a device including a reversible tubular distal multi-lumen drain. [Figure 6C] 6A-6B together depict a partially see-through side view of a device including a reversible tubular distal multi-lumen drain. [Figure 7A] 1 depicts an exemplary device having a plug and exemplary use of the device in a soft tissue region of the body. [Figure 7B] 7A illustrates the device with a plug and the use of the device. [Figure 7C] 7A-7B together depict the device with a plug and the use of the device. [Figure 8] 1 depicts an example device having a plug assembly controlled by axial movement of a handle and a reversible tubular distal multi-lumen drain. [Figure 9] 1 depicts one example plug assembly in which the elastic body has a compressible mesh cover. [Figure 10A] 1 depicts an exemplary plug assembly in which the outer surface of the elastomer is covered with a cover. [Figure 10B] Together with FIG. 10A, the plug assembly is depicted with the outer surface of the elastic body covered with a cover. [Figure 11A] 1 depicts an example plug assembly including multiple elastomers. [Figure 11B]11A illustrates a plug assembly including multiple elastomers. [Figure 11C] 11A-11B together depict a plug assembly including multiple elastomers. [Figure 12A] 1 depicts an example plug assembly configured to fold an elastic body to reduce its radial extent. [Figure 12B] 12A illustrates a plug assembly configured to fold an elastic body to reduce its radial extent. [Figure 13A] 1 depicts an example plug assembly configured to compress an elastic body by twisting. [Figure 13B] 13A illustrates a plug assembly configured to compress an elastic body by twisting. [Figure 14A] 1 depicts an example plug assembly in which a resilient body is axially disposed at the distal end of an elongate member. [Figure 14B] 14A illustrates a plug assembly having an elastic body axially disposed at the distal end of an elongate member. [Figure 14C] 14A-14B, taken together, depict a plug assembly having an elastic body axially disposed at the distal end of an elongate member. [Figure 14D] 14A-14C, taken together, depict a plug assembly having an elastic body axially disposed at the distal end of an elongate member. [Figure 15] 1 depicts an example elastic body having different axial cross-sectional shapes and different radial cross-sectional shapes. [Figure 16A] 10 depicts an embodiment of a reversible tubular distal multi-lumen drain configured to assume a curved shape when extended from an elongate member. [Figure 16B] 16A illustrates an embodiment of a reversible tubular distal multi-lumen drain configured to assume a curved shape when extended from an elongate member. [Figure 17A]1 depicts an example device including a reversible distal multi-lumen drain and plug. [Figure 17B] 17A depicts a device including a reversible distal multi-lumen drain and plug. [Figure 17C] 17A-17B together depict a device including a reversible distal multi-lumen drain and plug. [Figure 17D] 17A-17C together depict a device including a reversible distal multi-lumen drain and plug. [Figure 17E] 17A-17D together depict a device including a reversible distal multi-lumen drain and plug. [Figure 17F] 17A-17E together depict a device including a reversible distal multi-lumen drain and plug. [Figure 18A] 1 depicts an example device having a reversible distal multi-lumen drain that is biased to assume a curved shape when deployed. [Figure 18B] 18A illustrates a device having a reversible distal multi-lumen drain that is biased to assume a curved shape when deployed. [Figure 19] 1 is a flowchart of an example method of treating a body region using the devices described herein. [Figure 20A] 1 illustrates one embodiment of a sealing connector (e.g., a sealing cap) for connecting any of the devices described herein to a suction source. This figure shows the sealing cap prior to attachment. [Figure 20B] 20B shows the closure cap of FIG. 20A after installation. [Figure 21A] 1 illustrates one embodiment of a sealing connector (sealing cap) configured as a male sealing connector for connecting any of the devices described herein to a suction source. This figure shows the sealing cap prior to installation. [Figure 21B] 21B shows the closure cap of FIG. 21A after installation. [Figure 22A]1 illustrates one embodiment of a sealing connector (sealing cap) configured as a female sealing connector for connecting any of the devices described herein to a suction source. This figure shows the sealing cap prior to installation. [Figure 22B] 22B shows the closure cap of FIG. 22A after installation. [Figure 23A] 1 illustrates one embodiment of a sealing connector (sealing cap) configured as a female sealing connector for connecting any of the devices described herein to a suction source. This figure shows the sealing cap prior to installation. [Figure 23B] 23B shows the closure cap of FIG. 23A after installation. [Figure 24A] 22A-22B and 23A-23B coupled to a surgical drain device described herein. This figure shows a perspective view of the sealing cap. [Figure 24B] 24B shows a side view of the proximal end of the sealing cap and drain device of FIG. 24A. [Figure 24C] 24B shows an end view of the proximal end of the sealing cap and drain device of FIG. 24A. [Figure 24D] 24B shows another perspective view of the closure cap and drain device of FIG. 24A. [Figure 24E] 24B shows a perspective view of the proximal end of the sealing cap and drain device of FIG. 24A. [Figure 24F] 24B shows a cross-sectional view of the proximal end of the sealing cap and drain device of FIG. 24A. [Figure 25A] 21A-21B illustrates one embodiment of a sealing connector (sealing cap) similar to that shown in FIGS. 20A-20B and 21A-21B coupled to a surgical drain device described herein, showing a side view of the sealing cap and the proximal end of the drain device. [Figure 25B] 25B shows an end view of the proximal end of the sealing cap and drain device of FIG. 25A. [Figure 25C] 25B shows a partial transparent perspective view of the proximal end of the sealing cap and drain device of FIG. 25A. [Figure 25D]25B shows a perspective view of the proximal end of the sealing cap and drain device of FIG. 25A. [Figure 25E] 25B shows a cross-sectional view through the proximal end of the sealing cap and drain device of FIG. 25A. [Figure 26A] 10A-10C illustrate different embodiments of compressible / expandable plugs (e.g., foam plugs) or partial plugs that may be included as part of any of the devices described herein. The plugs shown may be part of a larger plug structure. [Figure 26B] 10A-10C illustrate different embodiments of compressible / expandable plugs (e.g., foam plugs) or partial plugs that may be included as part of any of the devices described herein. The plugs shown may be part of a larger plug structure. [Figure 26C] 10A-10C illustrate different embodiments of compressible / expandable plugs (e.g., foam plugs) or partial plugs that may be included as part of any of the devices described herein. The plugs shown may be part of a larger plug structure. [Figure 26D] 10A-10C illustrate different embodiments of compressible / expandable plugs (e.g., foam plugs) or partial plugs that may be included as part of any of the devices described herein. The plugs shown may be part of a larger plug structure. [Figure 26E] 10A-10C illustrate different embodiments of compressible / expandable plugs (e.g., foam plugs) or partial plugs that may be included as part of any of the devices described herein. The plugs shown may be part of a larger plug structure. [Figure 26F] 10A-10C illustrate different embodiments of compressible / expandable plugs (e.g., foam plugs) or partial plugs that may be included as part of any of the devices described herein. The plugs shown may be part of a larger plug structure. [Figure 26G] 10A-10C illustrate different embodiments of compressible / expandable plugs (e.g., foam plugs) or partial plugs that may be included as part of any of the devices described herein. The plugs shown may be part of a larger plug structure. [Figure 26H]10A-10C illustrate different embodiments of compressible / expandable plugs (e.g., foam plugs) or partial plugs that may be included as part of any of the devices described herein. The plugs shown may be part of a larger plug structure. [Figure 27A] 26A-26H depict an embodiment of a surgical drain device including a compressible / expandable plug structure using multiple partial plugs as shown in FIGS. 26A-26H. [Figure 27B] 26A-26H depict an embodiment of a surgical drain device including a compressible / expandable plug structure using multiple partial plugs as shown in FIGS. 26A-26H. [Figure 27C] 26A-26H depict an embodiment of a surgical drain device including a compressible / expandable plug structure using multiple partial plugs as shown in FIGS. 26A-26H. [Figure 27D] 26A-26H depict an embodiment of a surgical drain device including a compressible / expandable plug structure using multiple partial plugs as shown in FIGS. 26A-26H. [Figure 27E] 26A-26H depict an embodiment of a surgical drain device including a compressible / expandable plug structure using multiple partial plugs as shown in FIGS. 26A-26H. [Figure 27F] 26A-26H depict an embodiment of a surgical drain device including a compressible / expandable plug structure using multiple partial plugs as shown in FIGS. 26A-26H. [Figure 27G] 26A-26H depict an embodiment of a surgical drain device including a compressible / expandable plug structure using multiple partial plugs as shown in FIGS. 26A-26H. [Figure 28] 1A and 1B are schematic illustrations of an embodiment of a surgical drain device including a plug structure formed of a plurality of differently configured plug components having different bending stiffnesses; [Figure 29A] 10A-10C schematically depict an embodiment of a surgical drain device having a different compressible / expandable plug attached to the remainder of the device by adhesive. [Figure 29B]10A-10C schematically depict an embodiment of a surgical drain device having a different compressible / expandable plug attached to the remainder of the device by adhesive. [Figure 30A] 10A-10C schematically depict embodiments of a surgical drain device having a compressible / expandable plug attached to the remainder of the device by different types of adhesive. [Figure 30B] 10A-10C schematically depict embodiments of a surgical drain device having a compressible / expandable plug attached to the remainder of the device by different types of adhesive. [Figure 31A] 10A-10C show schematic diagrams of end views of devices with compressible / expandable plugs attached to the rest of the device by different types of adhesive. [Figure 31B] 10A-10C show schematic diagrams of end views of devices with compressible / expandable plugs attached to the rest of the device by different types of adhesive. [Figure 31C] 10A-10C show schematic diagrams of end views of devices with compressible / expandable plugs attached to the rest of the device by different types of adhesive. [Figure 31D] 10A-10C show schematic diagrams of end views of devices with compressible / expandable plugs attached to the rest of the device by different types of adhesive. [Figure 32A] 10A-10C schematically illustrate embodiments of a surgical drain device having different plug configurations and a fixed, inverted tube drain. [Figure 32B] 10A-10C schematically illustrate embodiments of a surgical drain device having different plug configurations and a fixed, inverted tube drain. [Figure 32C] 10A-10C schematically illustrate embodiments of a surgical drain device having different plug configurations and a fixed, inverted tube drain. [Figure 33A] 10A-10C schematically illustrate embodiments of a surgical drain device having different plug configurations and a fixed, inverted tube drain. [Figure 33B] 10A-10C schematically illustrate embodiments of a surgical drain device having different plug configurations and a fixed, inverted tube drain. [Figure 34A]10A-10C schematically illustrate embodiments of a surgical drain device having different plug configurations and a fixed, inverted tube drain. [Figure 34B] 10A-10C schematically illustrate embodiments of a surgical drain device having different plug configurations and a fixed, inverted tube drain. [Figure 35] 10 shows another embodiment of a surgical drain device having a fixed, everted (e.g., two-layer) drain tube with a multi-layer plug at its distal end. [Figure 36A] FIG. 29C schematically illustrates an embodiment of a surgical drain device having a compressible / expandable plug attached to the shaft of the device by adhesive, similar to the embodiment shown in FIG. 29A, but having an inverted (e.g., two-layered) drain tube secured to the distal end of the device. [Figure 36B] FIG. 29C schematically illustrates an embodiment of a surgical drain device having a compressible / expandable plug attached to the shaft of the device by adhesive, similar to the embodiment shown in FIG. 29B, but having an inverted (e.g., two-layered) drain tube secured to the distal end of the device. [Figure 37A] FIG. 30C schematically illustrates an embodiment of a surgical drain device having a compressible / expandable plug attached to the shaft of the device by adhesive, similar to the embodiment shown in FIG. 30A, but having an inverted (e.g., two-layered) drain tube secured to the distal end of the device. [Figure 37B] FIG. 30C schematically illustrates an embodiment of a surgical drain device having a compressible / expandable plug attached to the shaft of the device by adhesive, similar to the embodiment shown in FIG. 30B, but having an inverted (e.g., two-layered) drain tube secured to the distal end of the device. [Figure 38A] 10 illustrates the operation of another embodiment of a surgical drain having a passive seal with a non-rolling, deployable, dual-lumen drain connected to a retractable sheath. [Figure 38B] In conjunction with Figure 38A, the operation of the surgical drain is explained. [Figure 38C]38A-38B together illustrate the operation of the surgical drain. [Figure 39A] 10 illustrates the operation of another embodiment of a surgical drain device that includes a deployable / compressible plug assembly that includes a sheath. [Figure 39B] In conjunction with Figure 39A, the operation of the surgical drain is explained. [Figure 40A] 10 illustrates the operation of one embodiment of a surgical drain device that includes a deployable / compressible plug assembly that includes multiple straps. [Figure 40B] In conjunction with Figure 40A, the operation of the surgical drain is explained. [Figure 41A] 10A-10C schematically depict an embodiment of a surgical drain device having a breakaway plug assembly that can be removed by pulling a tether to at least partially break apart the plug. [Figure 41B] 10A-10C schematically depict an embodiment of a surgical drain device having a breakaway plug assembly that can be removed by pulling a tether to at least partially break apart the plug. [Figure 41C] 10A-10C schematically depict an embodiment of a surgical drain device having a breakaway plug assembly that can be removed by pulling a tether to at least partially break apart the plug. [Figure 42A] 10 illustrates the operation of another embodiment of a surgical drain device that includes a tether for converting the device from an expanded plug configuration to a collapsed plug configuration. [Figure 42B] In conjunction with Figure 42A, the operation of the surgical drain device is explained. DETAILED DESCRIPTION OF THE INVENTION

[0083]

[0123] Described herein are methods and apparatus (systems and devices) for draining an area of ​​the body to remove fluids or substances from the area and / or for contracting an area of ​​the body. This treatment can prevent or reduce bleeding and / or otherwise enhance healing. These apparatus and methods, including methods for using the apparatus, may be particularly useful for creating a uniform region of negative pressure within a cavity surrounded by soft tissue and for atraumatically removing the apparatus from the cavity while still maintaining the negative pressure. The apparatus may be designed to be easy to use.

[0084]

[0124] Described herein are devices including surgical drain systems that may include, for example, an elongated, optionally flexible, tubular body forming an outer shaft and a distal porous drain structure extending from the distal end region of the outer shaft. The distal porous drain structure may have one or more (preferably two or more) porous layers through which fluid (e.g., blood, lymph, etc.) can be passed and drained by application of negative pressure. The distal porous drain structure may also be referred to as a distal porous drain or porous structure. The distal porous drain may include a multi-layered tube of flexible material with multiple openings (e.g., pores), all along the length of the multi-layered tube. The multiple layers of the tube may be formed by everting the material over itself, causing the tubular porous material to double over. For example, a distal multi-lumen drain may be formed by everting a mesh (e.g., knitted, woven, and / or braided mesh) tube onto itself and attaching both ends of the everted tube to more proximal ends. The distal end formed by the double-folded everted region may be open or closed, generally forming a relatively flexible, atraumatic distal end. Thus, the distal multi-lumen drain has two tubular layers of porous material that together form a central lumen through which suction can be applied. The two (or possibly more) cylindrical layers forming the tubular multi-lumen drain allow fluid to be drawn through the pores, distributing suction across the multi-lumen drain and preventing suction locking, even when tissue compresses all or part of the distal multi-lumen drain.

[0085]

[0125] In some embodiments, the length of the distal multi-lumen drain may be static, with the ends of the everted porous material (e.g., mesh) fixed relative to one another. Alternatively, in some embodiments, the distal multi-lumen drain may be extendable or retractable in length, for example, by attaching a first end of the everted distal multi-lumen drain to a first shaft (e.g., an outer shaft) and attaching a second end of the distal multi-lumen drain to a second shaft (e.g., an inner shaft) concentric with the first shaft. The first end may be inverted relative to the second end. Thus, by moving the first shaft relative to the second shaft, the distal multi-lumen drain can be extended or retracted distally / proximally. Embodiments in which the distal multi-lumen drain is extendable or retractable by rolling and everting may be referred to herein as rolling drains. An embodiment in which the distal multi-lumen drain is everted onto itself but the ends are fixed relative to each other (e.g., both are attached to a shaft such as the outer shaft) is sometimes referred to as a non-rolling drain or equivalently a static drain.

[0086]

[0126] A device including a non-rolling drain may be manually inserted into the body region to be treated (e.g., the uterus). A device including a rolling drain may be partially inserted into the uterus (or up to an opening to the uterus), and one or both shafts may be moved relative to one another to extend the flexible distal multi-lumen drain distally into the body region to be treated (e.g., the uterus). Alternatively, a device with a rolling drain may be manually inserted in the same manner as a non-rolling drain, except that it is removed by moving one of the concentrically arranged shafts to retract the distal multi-lumen drain from the body. A non-rolling drain can be removed by withdrawing it proximally out of the body.

[0087]

[0127] Both non-rolling and rolling drains operate in the same manner to distribute negative pressure (e.g., suction) applied by the device within the body region being treated. For example, negative pressure can be applied through pores in a porous structure to force fluid into 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 at least partially contract the soft tissue walls surrounding the body cavity, reducing bleeding.

[0088]

[0128] As stated, the distal multi-lumen drain may be formed of two or more concentrically arranged layers having pores (e.g., openings) that allow fluid to pass through. The pores may be non-overlapping or partially overlapping between adjacent layers. The distal multi-lumen drain may be formed of concentrically arranged cylindrical layers. The porous layers may be formed as a mesh material. The distal multi-lumen drain may be flexible. In particular, the distal multi-lumen drain may be laterally compressible and may be compressed between the tissue wall or between layers, but due to the multiple porous layers, the distal multi-lumen drain does not create a vacuum lock within the tissue.

[0089]

[0129] The porous structure is configured to distribute negative pressure more effectively than existing surgical drains. The porous structure may have numerous interconnected pores distributed throughout the porous structure that act as a network of channels for drawing fluid and / or air from a body cavity (e.g., the uterus). Notably, in some of the embodiments described herein, the porous structure (e.g., fabric, mesh, etc.) may be formed of two or more adjacent layers. In some embodiments, a layer may be formed as an inverted tube folded back on itself. This can provide a more uniform negative pressure over a large surface area, thereby providing efficient removal of fluid and / or air and forming a network of channels that reduces clogging variations. The porous structure is typically conformable, allowing it to at least partially conform to the region of tissue into which it is positioned. In some embodiments, the porous structure may be a mesh made of woven, knitted, braided, and / or nonwoven materials. In some embodiments, the porous structure may be a fabric.

[0090]

[0130] The distal multi-lumen drain may be formed from a tube of porous material (e.g., mesh, fabric, such as a knitted, woven, or braided material) that is typically everted upon itself at its distal end to form two or more (e.g., multiple) layers of tubing. The distal end opening of the multi-layered tube may be open or closed. In some embodiments, the distal multi-lumen drain may be configured as a rolling drain that is everted and rolled upon itself for deployment and / or retraction. As mentioned, in some embodiments, the distal multi-lumen drain may be static, i.e., the distal multi-lumen drain is not rolled upon itself but is instead inserted into the body already deployed. In both rolling and non-rolling (static) drain embodiments, the distal multi-lumen 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.

[0091]

[0131] The distal multi-lumen drain may be coupled to one or more elongate members (e.g., a tube, a catheter, and / or a rod). At least one of the elongate members may include a lumen configured to provide negative pressure (e.g., a vacuum) to the distal multi-lumen drain. This suction lumen would be coupled to a distal region of the elongate member and thus to the distal multi-lumen drain. In some cases, the device may include one or more additional elongate members to assist in delivering and / or retracting the distal multi-lumen drain into and / or from the body region. In some embodiments, the device is configured to invert the distal multi-lumen drain during delivery and / or retraction of the distal multi-lumen drain from the body cavity.

[0092]

[0132] Any of these devices may include a sealing connector, e.g., a sealing cap or other sealing structure, at the proximal end of the device configured to releasably connect the proximal end of the elongate member (e.g., catheter, tubing, etc.) to a negative pressure source. The sealing connector may include a negative pressure coupler for connecting to the tubing or other negative pressure source and a distal sealing region for connecting to the distal end region of the elongate member. The sealing connector may be detachable from the elongate body and adapted to couple and seal to either or both the exterior and interior of the elongate body. Alternatively, in some embodiments, the sealing cap may be integral with the elongate body.

[0093]

[0133] Any of these devices may further include a plug assembly ("plug") or closure on the elongate shaft, typically proximal to the distal porous drain, that allows the area to be treated to maintain negative pressure within the body region. For example, the device may include one or more plugs or plug regions configured to contact surrounding soft tissue, such as a conduit or flow path leading to the body cavity to be treated, and configured (e.g., compressible and expandable) to deploy against the surrounding soft tissue and provide a seal with the surrounding soft tissue. The plug assembly may be a radially expandable and collapsible feature disposed along the elongate member proximal to the porous structure. The plug assembly may provide an embolic force (e.g., a sealing force) against the tissue of the flow path. Once negative pressure has been applied and maintained for a sufficient treatment time, the porous structure and plug may be collapsed and / or retracted for gentle removal from the body region. In some embodiments, the plug(s) or plug region(s) may be collapsed for collapse. In some embodiments, the plug or plug region may comprise a foam material (e.g., viscoelastic polyurethane foam or low-resilience polyurethane foam) that is compressible and self-expandable to fill and embolize a body passageway, conduit, etc. to maintain a vacuum distal to the plug. In some embodiments, the plug assembly is disassembled and removed.

[0094]

[0134] In some embodiments, the surgical drain devices described herein can include a delivery configuration with a relatively small OD that prevents or reduces trauma when the device is inserted into tissue. For example, the distal multi-lumen drain and / or plug assembly can be configured to be compressed to a sufficiently small OD for atraumatic entry into a body conduit, passageway, or cavity. In some cases, the distal multi-lumen drain and / or plug assembly can be configured for deployment out of and / or retraction into the elongate member of the device during deployment and / or retraction of the device from a body region. The distal multi-lumen drain and plug assembly can be configured to naturally (e.g., automatically) compress when placed within the confines of a body conduit or passageway and to naturally (e.g., automatically) deploy and apply a sealing force when placed within a larger body cavity or retracted outside the body.

[0095]

[0135] In any of the embodiments described herein, the distal multi-lumen drain structure is pushed or otherwise advanced and / or positioned into the body region to be drained, so that once positioned, the distal multi-lumen drain structure can remove fluid from the body region. Any tissue of the body may be treated using the surgical drains described herein. The tissue may include, among other things, formed or naturally occurring soft tissue regions, such as pockets, chambers, orifices, etc. The soft tissue to be treated may be a surgically or traumatically formed body region, such as a tunnel wound, dead space, a seroma-forming pocket (surgical wound), etc. For example, the soft tissue to be treated may be a cavity formed by the removal of a tumor or other tissue. In some embodiments, the soft tissue to be treated may be a natural orifice space (such as the bladder, intestine, stomach, uterus, chest cavity, lung, blood vessel, etc.). For example, the soft tissue to be treated may be a uterus.

[0096]

[0136] 1A-1F illustrate an embodiment of a surgical drain device 100 and an exemplary use of the surgical drain device 100 in a soft tissue region of the body. FIG. 1A shows a side view of the device 100 including an elongate member 102 (also referred to herein as an elongate shaft) and a distal multi-lumen drain 106 coupled to a distal region of the elongate member 102. In this embodiment, the elongate member 102 is a flexible tube (e.g., a polymeric tube) including a lumen 104. The lumen of the second elongate member 102 is in fluid communication with the distal multi-lumen drain. The distal multi-lumen drain 106, in this embodiment, is formed by a distal end region of the elongate member 102 that includes one or more openings that provide fluid access to the porous network of the distal multi-lumen drain 106, for example. The elongate member 102 (e.g., elongate shaft) can be of any suitable length to allow for steering and positioning of the distal multi-lumen drain 106 within the body region to be treated. For example, the elongate member 102 can be 5-100 cm long (e.g., 10-50 cm, 10-35 cm, etc.). The elongate member 102 can be straight (as shown) or curved, including a fixed curve (e.g., 10-80 degrees). In some cases, the elongate member 102 can be laterally flexible.

[0097]

[0137] In some cases, the elongate member 102 extends at least partially distally within the distal multi-lumen drain 106. In other cases, the elongate member 102 does not extend distally within the distal multi-lumen drain 106. In some embodiments, the distal multi-lumen drain 106 is configured as a rolling drain, where a second elongate member (elongate shaft, not shown) is concentrically disposed within the first elongate member 102 and connected to one end of the material (e.g., mesh) forming the distal multi-lumen drain. In general, the distal multi-lumen drain 106 may be radially compressible so that the outer diameter of the distal multi-lumen drain 106 is sufficiently small for entry into the soft tissue region. The distal multi-lumen 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 multi-lumen drain 106 may include a plurality of pores and / or a network of pores (e.g., mesh, open-cell structure) configured to draw fluid and / or air from a body cavity. In the cross-sectional view of FIG. 1B, the distal end of the distal multi-lumen drain 106 is shown as an open cylinder of mesh material that is folded back upon itself at the distal end of the multi-lumen drain region, which may form an atraumatic distal end region, i.e., both ends of the mesh material forming the distal multi-lumen drain are attached to the distal end region of the elongate shaft 102.

[0098]

[0138] FIG. 1C shows a first cross-sectional view of a soft tissue region of the body including a cavity 120 and a channel 122 leading to the cavity 120. The soft tissue region may be a surgical treatment site, such as a postpartum uterus or a tumor removal site. For example, the channel 122 may include a portion of the vaginal canal, and the cavity may include the postpartum uterus. FIG. 1D shows a second cross-sectional view (taken 90 degrees offset from the view shown in FIG. 1C). As shown, the tissue may be more open in one direction than another.

[0099]

[0139] 1E shows the device 100 after insertion into a body region and when negative pressure (suction) is applied. As shown, the distal multi-lumen drain 106 is positioned within the cavity 120, and the second elongate member 102 is positioned within the channel 122. In the illustrated embodiment, the distal multi-lumen drain 106 and the elongate member 102 are advanced through the lumen of the elongate introducer member 103. For example, the elongate introducer member 103 may be advanced within the channel 122 with the distal multi-lumen drain 106 disposed therein, and the elongate member 102 may then be forced relative to the elongate introducer member 103 to extend the distal multi-lumen drain 106 distally out of the elongate introducer member 103 and into the cavity 120. The elongate introducer member 103 may form a seal with the soft tissue wall of the channel 122 to allow sufficient negative pressure to be created within the cavity 120. The introducer member is optional. In some cases, an elongate introducer member 103 is included that has one or more sealing features (e.g., plugs) to facilitate sealing as described herein. In some embodiments, the device 100 includes a plug assembly extending from an outer surface of the elongate member 102.

[0100]

[0140] In some embodiments, one or more plug assemblies may be disposed between elongate introducer member 103 and elongate member 102. The one or more plug assemblies may be configured (e.g., shaped, positioned, or made of a suitable material) to allow elongate member 102 to slide within the lumen of elongate introducer member 103 without significant sliding force. For example, the seal may be an O-ring (or multiple O-rings), which may or may not be lubricated.

[0101]

[0141] In some embodiments, the distal multi-lumen drain 106 may be compressed to a compressed state before advancing through the channel 122. Once in the cavity 120, the distal multi-lumen drain 106 may be deployed to an expanded state. In some instances, the distal multi-lumen drain 106 may change shape (e.g., bend) at least partially upon insertion into the cavity 120, e.g., due to pressure from contact with surrounding tissue. In some instances, the distal multi-lumen drain 106 may be configured to assume a predetermined shape (e.g., a curved shape), e.g., to conform to the shape of a particular body cavity.

[0102]

[0142] In some embodiments, the elongate member 103 and / or the elongate introducer member 102 may include one or more stops that limit their relative axial movement. For example, the elongate member 103 and the elongate introducer member 102 may be configured to lock relative to one another when the distal multi-lumen drain 106 is distally extended and / or proximally retracted a predetermined amount. In some embodiments, the device includes one or more locks configured to releasably lock the relative axial position of the elongate member 103 and the elongate introducer member 102.

[0103]

[0143] Once the distal multi-port drain structure 106 is deployed, negative pressure may be applied through the lumen 104 of the elongate member 102 to force fluid and / or gas from the cavity 120 to flow proximally through the distal multi-port drain 106, into the elongate member 102, and ultimately out of the body tissue. For example, the elongate member 102 may include one or more openings at the distal end of the elongate member (and / or in the sidewall of the distal region of the elongate member 102). Typically, a suction lumen through the elongate member 102 will be in fluid communication with the lumen 111 of the distal multi-port drain. The distal multi-port drain 106 can maintain a shape that provides for efficient flow of fluid and / or gas through the network of pores in the distal multi-port drain 106, even when compressed by tissue, as shown in FIG. 1F . The negative pressure applied by the distal multi-lumen drain 106 can exert an inward force on the surrounding walls of the cavity 120 (indicated by the inward-pointing arrows in FIG. 1E), thereby at least partially contracting the cavity 120 (e.g., the uterus). Such contraction can be beneficial, for example, in cases where contracting the uterus after delivery can reduce bleeding.

[0104]

[0144] In some cases where the distal multi-lumen drain 106 has a tubular shape, the application of negative pressure may flatten the outer shape of the tube, creating a flattened tubular shape, although the pores of the distal multi-lumen drain may maintain their shape sufficiently to allow fluids, substances, and / or air to pass through.

[0105]

[0145] The distal multi-lumen drain 106 can be removed from the cavity 120 by moving the distal multi-lumen drain 106 proximally from the cavity 120. For example, the distal multi-lumen drain 106 may be retracted into the elongate introducer member 103. In some cases, retraction into the elongate introducer member 103 will radially contract the distal multi-lumen drain 106. In other embodiments where the elongate introducer member 103 is not used, the distal multi-lumen drain 106 may be pulled directly out of the cavity 120 by pulling on the elongate member 102. In embodiments where a plug assembly is included as part of the device, the plug assembly may optionally be adapted to collapse before or as the device is removed.

[0106]

[0146] The negative pressure may be maintained for a period of time to provide a therapeutic benefit. For example, the negative pressure may be applied until the cavity 120 has sufficiently drained fluid and / or until the cavity 120 has sufficiently contracted. In some embodiments, the period of time may range from 1 minute to several hours or even days. For example, the period of time may range from 1 minute to 5 days or more (e.g., 10 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, or 10 hours, 12 hours, 18 hours, 24 hours, 48 ​​hours, 3 days, 4 days, 5 days, etc.).

[0107]

[0147] In some embodiments, negative pressure is optionally maintained within the cavity 120 for a period of time after retraction of the distal multi-lumen drain 106 from the cavity 120. For example, in some cases, maintaining negative pressure after removal of the distal multi-lumen drain 106 may help to contract the uterus and reduce uterine bleeding. In some embodiments, negative pressure may be applied for a period ranging from 1 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 retraction of the distal multi-lumen drain 106 from the cavity 120. Negative pressure may be applied via the elongate member 102 (e.g., in versions using a rolling drain) and / or via the elongate introducer member 103 after retraction of the distal multi-lumen drain 106. Alternatively, the distal multi-lumen drain 106 and elongate member 102 may be completely withdrawn proximally out of the elongate introducer member 103 and negative pressure may be applied via the elongate introducer member 103. Once treatment is complete, the distal multi-lumen drain 106, elongate member 102, and elongate introducer member 103 may be proximally removed from the cavity 120 and flow channel 122.

[0108]

[0148] Any of the distal multi-lumen drain structures described herein may have an open pore structure, in which the pores / holes / spaces within the distal multi-lumen drain are interconnected to provide multiple channels throughout the distal multi-lumen drain. In some embodiments, the distal multi-lumen drain comprises a porous material (e.g., mesh, fabric, and / or textile) that may include woven, knitted, or braided elements (e.g., filaments). In some embodiments, the distal multi-lumen drain may be formed from a knitted fabric, woven fabric, braided fabric, nonwoven sheet (e.g., polymeric or metallic or composite), or more preferably, a flexible tube of material having pores. For example, in variations in which the distal multi-lumen drain is formed from a braided material, the braid may include any number of filaments, e.g., 24-144 strands / filaments (e.g., about 24-128 filaments, about 32-98 filaments, etc.). In some embodiments, the filaments are made of materials such as PET, nylon, PP, Nitinol, steel, Elgiloy, or any combination thereof. The filaments may be of any suitable diameter, such as filaments (e.g., monofilament or bicomponent filaments) between 0.003 and 0.025 inches (0.0762 and 0.635 mm) in diameter. In some embodiments, the distal multi-lumen drain is made of filaments (knitted, woven, braided, etc.) between 100 and 2000 denier (e.g., multifilament or monofilament). The mesh may have a monofilament or multifilament construction (or a mixture thereof).

[0109]

[0149] In some embodiments, the distal perforated drain structure ("distal perforated drain") is made of a nonwoven material such as a perforated material, a slit material, a felt, a meltblown material, and / or a foam material. For example, the distal perforated drain structure may be formed by extrusion, punching, stamping, blowing, laser cutting, and / or other manufacturing techniques. In some embodiments, the distal perforated drain structure may include an open-cell structure (e.g., open-cell or reticulated foam) containing interconnected pores / voids (e.g., cells). In some cases, the foam is similar to some types of wound dressing foams used with negative pressure. In some cases, the foam may be reinforced with an open textile structure (e.g., a netted tube, a sheet) to hold the foam together when placed under tension. For example, the foam may be a composite foam or a fabric-covered foam. In some embodiments, the distal multi-port drain includes a perforation pattern, e.g., having 1-4 mm holes (e.g., similar to a perforation having many holes per unit area). In some embodiments, the distal multi-port drain includes a slit pattern, e.g., having 1-3 mm wide by 1-15 mm long slits.

[0110]

[0150] The distal multi-lumen drain structures described herein can be made from any number of biocompatible materials. In some embodiments, the distal multi-lumen 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 thermoset material (e.g., a thermoplastic or thermoset foam). In some embodiments, the distal multi-lumen drain includes one or more metals (e.g., metal filaments), such as nickel-titanium alloys (e.g., Nitinol), steel, Elgiloy, and / or nickel-cobalt-chromium-molybdenum alloys (e.g., MP35N).

[0111]

[0151] The term "mesh" is not limited to structures formed of one or more strands; mesh may also be formed of a nonwoven material. The material forming the mesh may be a porous filter material such as Tyvek, filter paper, or the like, or the material may be (initially) nonporous with pores formed therein. The term "mesh" may refer to a material having an average porosity greater than 50% that can be formed into an evertable structure that is sufficiently malleable so that it can be folded back and everted upon itself. Mesh may be formed as a tubular or basket-like shape (e.g., open at both ends or with one end (e.g., the distal end) closed). In some cases, mesh may be formed into a generally tubular shape (open at one or both ends). In some cases, mesh may be formed into a non-tubular shape.

[0112]

[0152] The distal multi-lumen drain structures described herein may have any of a number of shapes. In some embodiments, the distal multi-lumen drain structure may have a tubular shape with an interior space (e.g., a lumen). In some cases, the distal multi-lumen drain may include multiple tubes of porous material (e.g., concentrically arranged). In some embodiments, the distal multi-lumen drain may have a non-tubular structure, for example, where the porous material runs the entire thickness of the distal multi-lumen drain (i.e., does not include an interior lumen).

[0113]

[0153] In any of the devices, one or more of the elongate members may be flexible, semi-ridged, or rigid. For example, the elongate member(s) may be formed from polyurethane or silicone. These devices can be configured to have reasonably high column strength while retaining bending flexibility.

[0114]

[0154] In any of the embodiments, the proximal direction may be the direction toward the hand of the user (e.g., therapist, surgeon, medical technician, nurse, etc.) operating the device, and the distal direction may be the direction away from the user's hand.

[0115]

[0155] 2A-2E show side views of example devices having different tubular distal multi-lumen drain structures in an extended and / or deployed state. Each of the tubular distal multi-lumen drain structures shown in FIGS. 2A-2E has a porous wall (e.g., a mesh wall) formed into a tubular shape, thereby defining an inner lumen. The porous wall has a number of pores configured to allow fluids, substances, and / or gases to pass therethrough when negative pressure is applied. Each of the tubular distal multi-lumen drains is coupled to the distal end region of a corresponding elongate member. In each figure, suction can be applied proximally (e.g., via the elongate member coupled thereto or another elongate member) to provide negative pressure to the tubular distal multi-lumen drain. Each of these embodiments may include multiple adjacent layers of porous material. The multiple layers may be formed by folding and inverting a tube of porous material over itself, or by placing one or more tubes, bags, or sheets of porous material concentrically within another tube or bag of porous material. Suction may be applied within the innermost channel (e.g., the innermost tube or bag of porous material, e.g., mesh) so that the suction passes through the multiple layers.

[0116]

[0156] Figure 2A shows a device having a tubular distal multi-lumen drain 206 connected to a distal region of an elongate member 202, such that when the tubular distal multi-lumen drain 206 is in a deployed state, the tubular distal multi-lumen drain 206 has an outer diameter approximately the same as the diameter of the elongate member 202. Figure 2B shows a device having a tubular distal multi-lumen drain 216 connected to a distal region of an elongate member 212, such that when the tubular distal multi-lumen drain 216 is in a deployed state, the tubular distal multi-lumen drain 216 has an outer diameter greater than the diameter of the elongate member 212. Figure 2C shows a device having a tubular distal multi-lumen drain 226 connected to a distal region of an elongate member 222, such that when the tubular distal multi-lumen drain 226 is in a deployed state, the tubular distal multi-lumen drain 226 has an outer diameter less than the diameter of the elongate member 222. Figure 2D illustrates a device having a tubular distal multi-lumen drain 236 coupled to a distal region of the elongate member 232, with the tubular distal multi-lumen drain 236 having a tapered outer diameter when the tubular distal multi-lumen drain 226 is in a deployed state. In the embodiment shown in Figure 2D, the tubular distal multi-lumen drain 226 tapers from a larger outer diameter at the proximal end of the tubular distal multi-lumen drain 226 to a smaller outer diameter at the distal end of the tubular distal multi-lumen drain 226. In other embodiments, the tubular distal multi-lumen drain may taper from a larger outer diameter at the distal end to a smaller outer diameter at the proximal end. Figure 2E illustrates a device having two tubular distal multi-lumen drains 246a and 246b (shown in a deployed state) coupled to a distal region of the elongate member 242. In the embodiment shown in Figure 2E, the tubular distal multi-lumen drains 246a and 246b are in a non-parallel arrangement relative to one another. In other embodiments, the tubular distal multi-lumen drains may be arranged in a parallel arrangement. An internal (second, third, fourth, etc.) layer of porous material may be present within each of the distal multi-lumen drains shown in Figures 2A-2E.

[0117]

[0157] The tubular distal multi-lumen drains described herein can have any number of shapes and are not limited to those shown in Figures 2A-2E. Additionally, the devices described herein can have any number of tubular distal multi-lumen drains (e.g., 1, 2, 3, 4, 5, 6, or more).

[0118]

[0158] 3A1-3E2 show distal end and side views of an additional exemplary device having a tubular distal multi-lumen drain configuration. FIG. 3A1 shows a distal end view of the device, and FIG. 3A2 shows a side view. Similar to the device of FIG. 2A, when the tubular distal multi-lumen drain 306 is in an extended / deployed state, the tubular distal multi-lumen drain 306 has an outer diameter approximately the same as the elongate member 302. As shown in the distal end view of FIG. 3A1, the tubular distal multi-lumen drain 306 has an outer porous wall 308 (e.g., a mesh wall) and an inner porous wall 311 that defines an interior space 309 (e.g., a lumen). The inner wall may be formed by everting a mesh into the outer wall (cylinder).

[0119]

[0159] FIG. 3B1 shows a distal end view and FIG. 3B2 shows a side view of a device having an elongate member 312 and a tubular distal multi-port drain structure 316. The tubular distal multi-port drain structure 316 defines an interior space 319 similar to the tubular distal multi-port drain 306, except that a sheath 317 covers the exterior surface of the tubular distal multi-port drain structure 316. The sheath 317 can control the amount of fluid and / or gas flowing through the tubular distal multi-port drain 316 when negative pressure is applied. For example, as shown in the distal end view of FIG. 3B1, the sheath 317 does not cover the distal end of the tubular distal multi-port drain 306. Fluid and / or gas can then access the tubular distal multi-port drain 316 through the open distal end. The sheath 317 may be a thin film made of a flexible / elastic polymer material (e.g., flexible polyurethane and / or silicone). In some cases, the sheath 317 may be made of a latex material. The sheath may have discrete openings along its length.

[0120]

[0160] For example, Figure 3C1 shows a distal end view and Figure 3C2 shows a side view of a device having an elongate member 322 and a tubular distal multi-lumen drain 326, the tubular distal multi-lumen drain 326 defining an interior space 329 and including a sheath 327 similar to sheath 317, except that sheath 327 includes openings 325 (e.g., holes) that allow fluids and / or gases to flow through sheath 327 and access tubular distal multi-lumen drain 326. Sheath 327 provides more efficient access for fluids and / or gases to reach tubular distal multi-lumen drain 326 compared to sheath 317, but less efficient access compared to an uncovered distal multi-lumen drain (e.g., Figures 3A1 and 3A2).

[0121]

[0161] Figure 3D1 shows a distal end view and Figure 3D2 shows a side view of the device having an elongate member 332 and a tubular distal multi-lumen drain 336, which defines an interior space 339 and has a sheath 337 similar to sheath 317, except that sheath 337 only partially covers tubular distal multi-lumen drain 336. In this embodiment, sheath 337 covers one side of tubular distal multi-lumen drain 336, leaving the opposite side of tubular distal multi-lumen drain 336 exposed.

[0122]

[0162] Figure 3E1 shows a distal end view and Figure 3E2 shows a side view of the device having an elongate member 342 and a tubular distal multi-lumen drain 346, which defines an interior space 349 and has a sheath 347 similar to sheath 337, except that sheath 347 covers two sides of tubular multi-lumen drain 346. In this embodiment, sheath 347 forms two slits 345a and 345b that are exposed along the length of tubular distal multi-lumen drain 346.

[0123]

[0163] 4A1-4E2 show distal end and side views of additional exemplary devices having different distal multi-lumen drains. FIG. 4A1 shows a distal end view and FIG. 4A2 shows a side view of a device having an elongate member 412 and a tubular distal multi-lumen drain 406 similar to tubular distal multi-lumen drain 306 (FIG. 3A) but closed at its distal end. The distal multi-lumen drain in this embodiment may include one or more interior layers (not visible in this embodiment) as described above, and the distal end may be closed by a single layer or multiple layers of porous (or non-porous) material.

[0124]

[0164] FIG. 4B1 shows a distal end view and FIG. 4B2 shows a side view of a device having an elongate member 412 and a tubular distal multi-lumen drain 416 similar to tubular distal multi-lumen drain 406, except that tubular distal multi-lumen drain 416 has a flattened outer shape (by pinching its distal end closed).

[0125]

[0165] Figure 4C1 shows a distal end view and Figure 4C2 shows a side view of a device having an elongate member 422 and a non-tubular distal multi-lumen drain 426. Compared to a tubular structure, the non-tubular distal multi-lumen drain 426 has porous material throughout the entire thickness of the distal multi-lumen drain 426 and does not include an inner lumen.

[0126]

[0166] FIG. 4D1 shows a distal end view and FIG. 4D2 shows a side view of the device having an elongate member 432 and a distal multi-lumen drain 436 that is similar to the non-tubular distal multi-lumen drain 426 except that it has a flat outer shape.

[0127]

[0167] FIG. 4E1 shows a distal end view and FIG. 4E2 shows a side view of a device having a first elongate member 442 and an invertible tubular distal multi-lumen drain 446. The invertible distal multi-lumen drain 446 is a rollable tube configured to be inverted by translating the second elongate member 441 relative to the first elongate member 442. A first end of the distal multi-lumen drain 446 is coupled to the first elongate member 442, and a second end of the distal multi-lumen drain 446 is coupled to the second elongate member 441. This configuration allows the tubular distal multi-lumen drain 446 to invert upon relative distal / proximal movement between the first elongate member 442 and the second elongate member 441. In the illustrated embodiment, the invertible distal multi-lumen drain 446 has a rounded outer shape. In other embodiments, the reversible distal multi-lumen drain has a different exterior shape, such as a flat exterior shape (e.g., similar to the flat exterior shape of the tubular distal multi-lumen drain 416). In some embodiments, the distal multi-lumen drain may have a free (e.g., distal) end (e.g., not connected to the second elongate member 441).

[0128]

[0168] 5A1-5A4 illustrate one example of how a device 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. FIGS. 5A1 and 5A2 show a distal end view and a side view of the device when negative pressure is applied within the elongate member 502 (e.g., as indicated by the arrows). The negative pressure creates a flow 550 of fluid and / or gas through a network of pores in the porous walls 516, 555 of the tubular distal porous drain 506 and into the interior space 509 (e.g., lumen) of the tubular distal porous drain 506. Once in the interior space 509, the flow 550 is directed proximally toward the elongate member 502 and ultimately out of the body cavity where it is drained and / or contracted. Additionally, a portion of the flow 550 will be directed axially along / between the porous walls 516 , 555 of the tubular distal porous drain 506 in a proximal direction towards the elongate member 502 .

[0129]

[0169] 5A3 and 5A4 show a distal end view and a side view of the device when at least a portion of the tubular distal porous drain 506 is radially compressed / flattened to reduce or eliminate the internal space 509. Even with the reduced or eliminated internal space 509, fluid and / or gas flow 550 can still flow axially along the porous walls 516, 555 of the tubular distal porous drain 506 proximally toward the elongate member 502. This aspect may allow the device to function in situations where at least a portion of the tubular distal porous drain 506 has been compressed by surrounding tissue while within the body cavity. Additionally, the network of pores within the porous walls 516, 555 can create a wicking effect that moves fluids more quickly throughout the length of the tubular distal porous drain 506.

[0130]

[0170] As noted, in some embodiments, the device is configured to evertate (also known as wrap) the tubular distal multi-lumen drain. In some cases, an evertable tubular distal multi-lumen drain may reduce shear forces on surrounding tissue during removal. Figures 6A-6C show a partially see-through side view of an example device 600 including an evertable tubular distal multi-lumen drain 606. In this embodiment, the device 600 includes a tubular distal multi-lumen drain 606 having a first end 607 coupled to a distal end region of a first (e.g., outer) elongate member 603 and a second end 609 coupled to a distal end region of a second (e.g., inner) elongate member 602. 6A shows the device 600 with the second elongate member 602 urged distally relative to the first elongate member 603 to extend the second end 609 of the distal multi-lumen drain 606 distally (e.g., into the body cavity). As shown, the distal multi-lumen drain 606 can have a generally single-walled, tubular shape with the second elongate member 602 extended into the first lumen 611 of the tubular distal multi-lumen drain 606.

[0131]

[0171] 6B shows the device 600 with the second elongate member 602 pulled proximally within the first elongate member 603, resulting in the distal multi-lumen drain 606 being partially everted. In this partially everted state, the wall of the distal multi-lumen drain 606 doubles over itself to form a double-walled tubular shape and define a second lumen 621 formed by the distal multi-lumen drain 606. Optionally, the device may be configured to apply suction to cause fluid to flow into the second lumen 621 and proximally out of the distal multi-lumen drain 606. In the illustrated embodiment, the second elongate member 602 may be fully retracted distally within the first elongate member 603, allowing the distal multi-lumen drain 606 extending out of the first elongate member 603 to have greater lateral flexibility (e.g., as compared to when the second elongate member 602 is extended distally within the distal multi-lumen drain 606, as in FIG. 6A ). This may allow the distal multi-lumen drain 606 to bend laterally during use, for example, upon contact with a tissue wall within the body cavity. In some embodiments, the distal end of the second elongate member 602 is positioned proximate to the distal end of the first elongate member 603 to maximize the length that the distal multi-lumen drain 606 in its double-walled tubular configuration extends distally from the first elongate member 603.

[0132]

[0172] In some cases, the first elongate member 603 and / or the 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, the distal multi-lumen drain 606 may be stopped and / or locked in a double-walled tubular configuration (e.g., with the second elongate member 602 fully retracted distally into the first elongate member 603) as shown in FIG. 6B. Additionally or alternatively, the distal multi-lumen drain 606 may be stopped and / or locked in a distally extended configuration in which the second elongate member 602 is distally extended relative to the first elongate member 603 as shown in FIG. 6A, and / or in a retracted configuration in which the distal multi-lumen drain 603 is everted and retracted into the lumen of the first elongate member 603 as shown in FIG. 6C.

[0133]

[0173] FIG. 6C illustrates the device 600 after the second elongate member 602 has been further pulled proximally, resulting in the distal multi-lumen drain 606 being almost completely everted, thereby assuming a generally inside-out (compared to FIG. 6A) single-walled tubular configuration and forming the third lumen 628. As shown, the distal multi-lumen drain 606 is also largely retracted within the first elongate member 603. Further proximal movement of the second elongate member 602 can cause the distal multi-lumen drain 606 to be fully retracted within the first elongate member 603 in its everted tubular configuration. The device 600 may be configured to apply negative pressure to the invertible tubular distal multi-lumen drain 606 in either inverted configuration. For example, it may be beneficial to apply suction when the distal multi-lumen drain 606 is fully extended distally (e.g., FIG. 6A) to access more distal regions of the body cavity. Alternatively or additionally, it may be beneficial to apply suction when the distal porous drain 606 is in a double-walled state (e.g., FIG. 6B), i.e., when the second elongate member 602 has been retracted, making the distal porous drain 606 more flexible and thereby allowing the distal porous drain 606 to more easily conform to the geometry of the body cavity.

[0134]

[0174] As mentioned, one difference between devices with an invertible tubular distal multi-lumen drain (e.g., FIGS. 6A-6C) and devices with a non-invertible distal multi-lumen drain (e.g., FIGS. 2A-4D2) is that the non-invertible distal multi-lumen drain may have a distal end that extends freely from the elongate member (e.g., the second elongate member). That is, the distal end of the non-invertible distal multi-lumen drain does not need to be connected to the elongate member. In some cases, this may allow the non-invertible distal multi-lumen drain to bend and conform around body tissue more easily.

[0135]

[0175] Any of the devices described herein may be axially flexible so that they can bend around structures or non-uniform volumes. In variations, the device may be introduced into a body orifice through a natural or flow path, such as when treating the uterus by passing through the vaginal canal.

[0136]

[0176] As discussed, the distal multi-port drain may be made of a textile (e.g., mesh) material. In one embodiment, the textile is a woven tube (e.g., 5-50 picks per inch (ppi)) having an outer diameter in the range of 8-20 mm using monofilament warp and weft (e.g., 0.005-0.1 inch (0.127-2.54 mm) diameter). In another embodiment, the textile comprises a braided material having an outer diameter in the range of 8-20 mm using 50-200 filaments at 5-50 ppi with a diameter in the range of 0.005-0.1 inch (0.127-2.54 mm). In an additional embodiment, the textile comprises PET monofilament having a diameter in the range of 0.005-0.1 inch (0.127-2.54 mm) knitted into a circular knit (e.g., 36-needle head).

[0137]

[0177] The devices described herein may be scaled to various suitable sizes to treat soft tissue regions of different sizes and shapes. For example, in some variations, the distal porous drain may be 10-100 cm long (e.g., proximal-distal length) in the delivery configuration. In embodiments in which the distal porous drain is formed from a sheet of material having pores formed therethrough, the sheet may be a film with slits, holes, slots, molded holes, etc., formed in a pattern through the sheet. The pore pattern of the distal porous drain may be uniform or non-uniform and may have an average pore density (porosity) as a percentage 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.).

[0138]

[0178] As discussed herein, any of the devices may include one or more sealing features that serve to seal the device against tissue, for example, within a flow channel, to create negative pressure for sufficient drainage and / or contraction of a body cavity. Figures 7A-7C illustrate an example device 700 having sealing features and its example use in a soft tissue region of the body. Figure 7A shows a side, partially perspective view of device 700 including a first (e.g., outer) elongate member 703, a second (e.g., inner) elongate member 702, and a distal multi-lumen drain 706 coupled to a distal region of second elongate member 702. Additionally, a plug 730 (also referred to as an occluder) is positioned around a portion of first elongate member 703 proximal to distal multi-lumen drain 706. The plug 730 may be made of an elastomer made of a resilient material (e.g., foam or sponge) that can be radially compressed (e.g., when positioned within and removed from the channel 722) and regain its expanded state to create a seal against the tissue wall. In some cases, the plug 730 may include one or more coverings configured to apply a radial compressive force to the elastomer to reduce the outer diameter of the plug 730. The plug 730 may be disposed such that the lumen of the first elongate member 703 passes through the plug 730, thereby allowing the second elongate member 702 to pass therethrough and apply suction to the distal multi-lumen drain 706 via either the first elongate member 703 or the second elongate member 702.

[0139]

[0179] 7B shows a cross-sectional view of a soft tissue region of the body including a cavity 720 and a channel 722 leading to the cavity 720. The soft tissue region may be a postpartum uterus or a surgical treatment site such as a tumor removal site. For example, the channel 722 may include a portion of the vaginal canal and the cavity may include the postpartum uterus.

[0140]

[0180] 7C illustrates the device 700 as negative pressure is being applied after insertion into a body region. As shown, the distal multi-port drain 706 is positioned within the cavity 720, and the first elongate member 702 has a plug 730 positioned within the channel 722. The diameter of the first elongate member 702 does not have to be large enough to seal the cavity 720. However, the plug 730 can be deployed within the channel 722 to form a seal with the soft tissue walls of the channel 722 so that sufficient negative pressure can be created within the cavity 702. Once the distal multi-port drain 706 is released within the cavity 720, negative pressure can be applied (e.g., through the lumens of the first elongate member 703 and / or second elongate member 702) to cause fluid and / or gas from the cavity 720 to flow proximally through the distal multi-port drain 706 and ultimately out of the body tissue. Alternatively or additionally, the negative pressure applied by the distal multi-port drain 706 may apply an inward force (indicated by the inward-pointing arrow) to the surrounding walls of the cavity 720, thereby causing the cavity 720 (e.g., the uterus) to at least partially contract.

[0141]

[0181] After a sufficient period of negative pressure, the distal multi-lumen drain 706 may be retracted from the cavity 720. For example, the second elongate member 702 may be pulled relative to the first elongate member 703 to pull the distal multi-lumen drain 702 into the lumen of the first elongate member 703. As described herein, in some embodiments, optionally, negative pressure is maintained within the cavity 720 for a period of time after the distal multi-lumen drain 706 is retracted from the cavity 720. Once treatment is complete, the distal multi-lumen drain 706, second elongate member 702, and first elongate member 703 may be proximally removed from the cavity 720 and the flow passage 722. Prior to removal of the first elongate member, the plug 730 may be radially compressed. In some examples, the plug 730 is compressed by a cover / sheath configured to reduce the radial geometry of the plug.

[0142]

[0182] FIG. 8 illustrates an example device having a plug assembly 830. In this case, deployment and contraction of plug 830 is controlled by axial movement of proximal connector 838. Plug 830 may include an elastic material (e.g., foam or sponge) that can be radially compressed and expanded. Plug 830 may include a cover 833 that covers the elastic material. Proximal connector 838 may slidably connect a proximal side of cover 833 to first elongate member 803, and distal connector 839 fixedly connects a distal side of cover 833 to first elongate member 803. Cover 833 may be made of any of a number of materials. In some cases, cover 833 may include one or more layers of material. In some embodiments, cover 833 may include a sheet of polymeric material (e.g., polyethylene (e.g., lightweight), nitrile) and / or mesh material. At least one layer (e.g., a compression layer) of the cover 833 may be adapted to be axially tightened or 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 elongate member 803. For example, the proximal connector 838 may be pulled proximally (e.g., manually or via an actuator) to axially stretch and tighten the cover 833, thereby applying radially inward pressure to the elastic body of the plug 830. The radially inward pressure may radially squeeze the elastic body, reducing the outer diameter of the plug 830. In some instances, the cover 833 includes an additional layer or membrane (e.g., a fluid barrier layer or membrane) configured to provide a fluid barrier and / or improve the seal of the plug 830 with surrounding tissue. In some embodiments, a single layer may serve to both compress the elastic body and provide a fluid barrier. For example, the outer diameter of plug 830 may be reduced during insertion or repositioning of plug 830 within the body passageway.Once in the desired position within the body passageway, the proximal connector 838 may be released to loosen the cover 833 and release the radially inward pressure on the elastic body of the plug 830, thereby allowing the plug 830 to deploy and create a seal against the tissue wall within the body passageway.

[0143]

[0183] 8, the plug assembly 830 includes an opening (e.g., a central opening) that accommodates a first elongate member 803 that provides suction to the distal multi-lumen drain 806. In this embodiment, the device includes an invertible tubular distal multi-lumen drain 806 configured to transition between a tubular state and an inverted tubular state as a second elongate member 802 coupled to the distal multi-lumen drain 806 is moved proximally and distally. Additionally, in the illustrated embodiment, a vacuum port 842 is configured to provide negative pressure to the distal multi-lumen drain 806 via the lumens of the first elongate member 803 and / or the second elongate member 802.

[0144]

[0184] 9 shows an example plug assembly 930 having a cover 933 in which the elastic body 934 is a deployable mesh. The outer diameter of the elastic body 934 may be reduced by pulling the proximal connector 932 to stretch the cover 933, thereby applying a radially inward force to the elastic body 934. The outer diameter of the elastic body 934 may return to its original size by releasing the proximal connector 932 to provide slack to the cover 933, thereby releasing the radially inward force on the elastic body 934. In some cases, the mesh cover 933 is covered with an additional layer that can also function as a fluid barrier.

[0145]

[0185] 10A-10B illustrate another example plug assembly 1030. The outer surface of an elastomeric body 1034 is covered with a cover including a compressible layer 1033 and a fluid barrier layer 1036. FIG. 10A illustrates the plug 1030 in a radially expanded state, and FIG. 10B illustrates the plug 1030 in a radially contracted state. The plug 1030 is disposed around an elongate member 1003 (e.g., a first elongate member). Distal ends of the compressible layer 1033 and the fluid barrier layer 1036 are fixedly connected to the elongate member 1003 via a first (e.g., distal) connector 1039. Proximal ends of the compressible layer 1033 and the fluid barrier layer 1036 are slidably connected to a second (e.g., proximal) connector 1038 relative to the elongate member 1003. In this embodiment, the second connector 1038 has an elongated proximal side 1032 that can also serve as a handle. The first connector 1039 and the second connector 1038 may also be referred to as cuffs or collars. In some embodiments, the first connector 1039 and the second connector 1038 include a band (e.g., an elastic band) and / or a washer. When the second connector 1038 is actuated proximally (e.g., by pulling the handle 1032 manually or with an actuator), as shown in FIG. 10B , the compressible layer 1033 stretches and applies a radial compressive force to the elastic body 1034, thereby reducing the outer diameter of the elastic body 1034 and plug 1030. When the proximal axial force applied to the second connector 1038 is released (e.g., by releasing the handle 1032), the compressible layer 1033 becomes slack and the radial compressive force is released, thereby reducing the outer diameter of the elastic body 1034 and plug 1030, as shown in FIG. 10B . In some embodiments, the radially deployed state of the elastic body 1034 (FIG. 10A) will be stiffened based on the extent to which the second connector 1038 is distally displaced along the axis and the amount of axial force applied distally to the elastic body 1034. For example, a distal axial force sufficient to axially compress the elastic body 1034 can be applied to the second connector 1038 to stiffen and stiffen the elastic body 1034 in the deployed state.

[0146]

[0186] In some cases, the plug assembly 1030 may include one or more stops and / or locks 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 elongate body 1003. Thus, in the case of a lock(s), the resilient body 1034 can be locked in a radially deployed state (e.g., FIG. 10A ) or in a radially compressed state (e.g., FIG. 10B ).

[0147]

[0187] Fluid barrier layer 1036 may be a thin layer of fluid resistant material. In some embodiments, fluid barrier layer 1036 may be made of polyethylene (e.g., lightweight polyethylene), nitrile, or a nitrile-like low-stretch material. The thickness of fluid barrier layer 1036 may vary depending on the material. In some embodiments, fluid barrier layer 1036 has a thickness in the range of approximately 0.0001 to 0.01 inches (0.00254 to 0.254 mm). Compressible layer 1033 may have a relatively high tensile strength so that it can apply a radially inward pressure to elastic body 1034. In some cases, compressible layer 1033 is a tubular mesh. In one embodiment, the compressible layer 1033 is a tubular woven braid having a diameter ranging from approximately 3 to 5 inches (76.2 to 127 mm) and comprising approximately 100 to 200 monofilaments having a diameter ranging from approximately 0.005 to 0.1 inches (0.127 to 2.54 mm). The elastic body 1034 may be made of any of a number of elastic materials, such as a polymer foam or sponge material. In some embodiments, the elastic body 1034 has flat sides (axially) to create a predetermined angle 1031 between the elastic body 1034 and the elongate member 1003. In some cases, the predetermined angle is approximately 90 degrees (a right angle), which will allow for the greatest diameter change of the elastic body 1034 per stretched length.

[0148]

[0188] 11A-11C illustrate an example plug assembly 1130, which is similar to plug assembly 1030 except that it includes three elastic bodies 1134a, 1134b, and 1134c configured to provide an enhanced deployment force upon deployment. FIG. 11A illustrates plug assembly 1130 in a deployed state, FIG. 11B illustrates plug assembly 1130 in a reinforced deployed configuration, and FIG. 11C illustrates plug assembly 1130 in a contracted state. Elastic bodies 1134a, 1134b, and 1134c can be configured to slide axially relative to elongate member 1103 such that actuating second connector 1132 distally (e.g., by pushing handle 1132 distally) drives first connector 1138 toward second connector 1139, thereby compressing elastic bodies 1134a, 1134b, and 1134c relative to one another and enhancing the deployed state of plug 1030. Optionally, washers 1140 and 1141 may be disposed proximally and distally of the bodies 1134a, 1134b, and 1134c, respectively, to enhance pushing force. Optionally, the first connector 1138 and the second connector 1139 and / or the washers 1140 and 1141 may be configured to lock the bodies 1134a, 1134b, and 1134c in a radially deployed state (FIG. 11A), a reinforced radially deployed state (FIG. 11B), and / or a radially contracted state (FIG. 11C). Like plug assembly 1030, plug assembly 1130 includes a cover including a compressible layer 1133 and a fluid barrier layer 1136.

[0149]

[0189] 12A-12B illustrate an example plug assembly 1230, similar to plug assembly 1030, except that the plug assembly 1230 is configured to fold the elastic body 1234 to reduce its radial size. The position of the elastic body 1234 may be configured to remain axially fixed relative to the elongate member 1203. When the second connector 1238 is actuated proximally (e.g., by pulling the handle 1232), the first connector 1239 prevents distal axial movement of the elastic body 1234, and the elastic body 1234 folds radially inward (e.g., proximally) as shown in FIG. 12B, reducing the diameter of the plug 1230. Optionally, a stopper 1240 (e.g., a band or washer fixedly coupled to the elongate member 1203) may prevent proximal axial movement of the elastic body 1234 when the handle 1232 is pulled proximally. Additionally or alternatively, the elastic body 1234 may be secured (e.g., glued) to the elongate member 1203, for example, by an adhesive. Once the handle 1232 is released, the compression force is released, allowing the elastic body 1234 to retain its deployed state (FIG. 12A). The plug assembly 1230, like the plug assembly 1030, includes a cover including a compressible layer 1233 and a fluid barrier layer 1236.

[0150]

[1090] 13A-13B illustrate an example plug assembly 1330 that is similar to plug assembly 1030, except that plug assembly 1330 is configured to compress body 1334 by rotating second connector 1338 relative to elongate member 1303 (e.g., by rotating handle 1332). Rotating second connector 1338 relative to elongate member 1303 twists compression layer 1333, generating an inward compressive force on body 1334, as shown in FIG. 13B. As described above, plug assembly 1330 may include one or more locks configured to lock body 1334 in a radially deployed state and / or a radially compressed state. For example, the radial position of the handle 1332 relative to the elongate member 1303 may be locked (e.g., by a lock on the side of the second connector 1338 and / or a separate lock) to maintain the compressible layer 1333 in a twisted and / or untwisted state. When the second connector 1338 is unwound, the compressive force is released and the elastic body 1334 returns to the deployed state (e.g., FIG. 13A ). The plug assembly 1330, like the plug assembly 1030, includes a cover including the compressible layer 1333 and the fluid barrier layer 1336.

[0151]

[0191] 14A-14D illustrate an example plug assembly 1430, similar to plug assembly 1030, except that the elastic body 1434 is axially disposed near or at the distal end of the elongate member 1403. For example, the elastic body 1434 may be axially disposed closer to a distal multi-lumen drain (not shown in FIGS. 14A and 14B) described herein. In this embodiment, the distal portion of the elastic body 1434 is located distally beyond the distal end of the elongate member 1403 when in the deployed state (FIG. 14A). A more distal location of the elastic body 1434 may be ideal for situations where the body passageway is short, such as a relatively short cervical canal. As shown in the embodiment of FIG. 14B, the elastic body 1434 may be configured to axially shift proximally relative to the distal end of the elongate member 1403 when the handle 1432 is pulled proximally. Plug assembly 1430 , like plug assembly 1130 , includes a cover that includes a compressible layer 1433 and a fluid barrier layer 1436 .

[0152]

[0192] 14C and 14D show a plug assembly 1430 coupled to a distal multi-lumen drain 1406. In this example, the distal multi-lumen drain 1406 is a tubular structure configured to evert, as described herein. FIG. 14C shows the distal multi-lumen drain 1406 extended 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 multi-lumen drain 1406, a second (e.g., inner) elongate member 1402 coupled to the distal end of the tubular distal multi-lumen drain 1406 can be pulled proximally relative to the elongate member 1403 (e.g., outer elongate member), thereby everting and retracting the tubular distal multi-lumen drain 1406 proximally into the elongate member 1403.

[0153]

[0193] FIG. 15 shows exemplary shapes (axial and radial cross sections) of elastic bodies in a stretched state. Exemplary elastic bodies A1 and A2 have a rectangular axial cross section (axial relative to the central opening 1501 of the elongate body) as shown in A1 and a round radial cross section (radial relative to the central opening 1501) as shown in A2. Exemplary elastic bodies B1 and B2 have a rectangular axial cross section as shown in A1 and an oval (e.g., elliptical) radial cross section as shown in B2. Exemplary elastic bodies C1 and C2 have a rectangular axial cross section as shown in C1 and a round radial cross section as shown in C2, and also have radially extending slits or openings 1555. Exemplary elastic bodies D1 and D2 have a round axial cross section as shown in D1 and a round radial cross section as shown in D2. Exemplary elastic bodies E1 and E2 have an oval (e.g., elliptical) axial cross section as shown in E1 and a round radial cross section as shown in E2.

[0154]

[0194] As mentioned, any of the devices described herein may include one or more locks configured to maintain the axial position of the distal multi-lumen drain relative to the first elongate member and / or maintain the plug in a radially deployed and / or radially compressed state. In some cases, the lock may be configured to maintain the relative position until additional force is applied to overcome the retaining force. For example, the lock may include a ratchet element on the proximal end of the device (e.g., on or part of a handle at the proximal end).

[0155]

[0195] 16A-16B illustrate an example invertible tubular distal multi-lumen drain 1606 configured to assume a curved shape when extended from a first elongate member 1603. FIG. 16A illustrates the tubular distal multi-lumen drain 1606 in a generally inverted state, retracted within the first elongate member 1603. FIG. 16B illustrates the tubular distal multi-lumen drain 1606 after it has been advanced distally relative to the first elongate member 1603 (e.g., by pushing the second elongate member 1602). As illustrated, the tubular distal multi-lumen drain 1606 is biased to assume a curved configuration (e.g., a "C" shape) when deployed. This configuration may be useful in situations where the body cavity has a curved or curved shape and / or where certain body cavity regions are difficult to reach. Additionally, the tubular distal multi-lumen drain 1606 may be flexible to conform to body tissue, thereby preventing damage to the tissue. The distal multi-lumen drains described herein may be configured to assume any number of curved shapes (e.g., banana-shaped, "S"-shaped, "J"-shaped, etc.) and are not limited to the "C" shape of the embodiment of Figures 16A and 16B. Furthermore, any of the distal multi-lumen drains described herein (tubular, non-tubular, reversible, non-reversible) may be configured to assume a curved shape and are not limited to the reversible tubular distal multi-lumen drain embodiment of Figures 16A and 16B.

[0156]

[0196] 17A-17F illustrate an example device 1700 including an invertible distal multi-lumen drain structure ("distal multi-lumen drain") 1706 and a plug 1730. These figures show the invertible distal multi-lumen drain 1706 in a partially inverted state, in which the wall of the distal multi-lumen drain 1706 is doubled over to form a double-walled tubular configuration (e.g., similar to FIG. 6B). In this configuration, the second elongate member 1703 (coupled to the (e.g., distal) end of the tubular distal multi-lumen drain 1706) is retracted within the first elongate member 1702. This configuration can provide the distal multi-lumen drain 1706 with greater lateral flexibility, for example, when traversing a body cavity, compared to when the second elongate member 1702 is extended distally into the distal multi-lumen drain 1706. The plug 1730 includes an inner elastomeric body (e.g., a porous polymer material) and a cover coupled to the first elongate member via a first connector 1739 and to the plug handle 1732 via a second connector 1738. In this embodiment, the cover includes a compressible layer (e.g., a mesh) and an outer fluid barrier layer.

[0157]

[0197] 18A-18B show an example surgical drain device 1800 that is similar to surgical drain device 1700, except that the reversible distal multi-lumen drain structure 1706 is configured to assume a curved ("C" shape) when deployed into a double-walled tubular configuration, as shown in FIG. 18B.

[0158]

[0198] FIG. 19 is a flowchart illustrating an exemplary method of treating a body region using a device described herein. The body region may be a wound, a body cavity, a duct, a passageway, or a postpartum uterus. The method includes step 1901 of positioning at least a portion (e.g., a distal end) of a distal multi-lumen drain into the body region. The distal multi-lumen drain may have pores large enough to allow the passage of fluids (liquids and gases) and possibly biological debris (e.g., pus, clots, etc.) without significant resistance. The distal multi-lumen drain may be configured to assume a shape that distributes negative pressure within the body region. The distal multi-lumen drain may have multiple layers (e.g., formed of an everted mesh) and may have a first end (e.g., a proximal end) connected to the distal region of the elongate member and a second end (e.g., a distal end) extending freely from the elongate member. For example, the distal multi-lumen drain may have a tubular shape with a porous wall that terminates at the distal end of the distal multi-lumen drain. In some cases, the distal multi-lumen drain is a non-tubular structure. In some cases, the distal multi-lumen drain has a porous wall that doubles over at the distal end of the distal multi-lumen drain (e.g., a reversible distal multi-lumen drain).

[0159]

[0199] Before, during, or after releasing the distal porous drain structure within the body region, the method may include step 1903 of creating a seal to maintain a vacuum within the body region. In some cases, an outer surface of an elongate member coupled to the distal porous drain is configured to create a seal with surrounding tissue near the body region (e.g., within the fluid passage). In some embodiments, the elongate member includes a plug positioned proximally relative to the distal porous drain, the plug having an expandable outer diameter to assist in creating the seal. The plug may include an inner resilient body, e.g., a viscoelastic foam body, and a compressible layer surrounding the resilient body and configured to apply a compressive force to reduce the diameter of the resilient body. The resilient body may be configured to be radially compressed and / or folded to reduce the diameter of the plug (e.g., for insertion into the fluid passage). The resilient body may be made of a resilient material such as a foam (e.g., a porous polymeric material). The plug may optionally include a fluid barrier (e.g., a layer) to prevent fluid from contacting the resilient body and / or the compressible layer. The plug may optionally include a lock configured to lock the plug in the radially deployed state and / or the radially compressed state. The device may be configured to activate the plug by a handle configured to stretch, shorten, and / or twist the compressible layer.

[0160]

[0200] Negative pressure may then be applied through the distal multi-lumen drain (e.g., by applying negative pressure through the lumen of the elongate member) 1905. In some cases, negative pressure may be maintained for approximately 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 region has been drained and / or contracted and sufficient negative pressure has been applied, the distal multi-lumen drain may be removed (retracted) 1907 from the body region. For example, the elongate body may be pulled proximally, retracting the distal multi-lumen drain with it. In some embodiments, the distal multi-lumen drain is retracted into the elongate member, for example, by pulling on a second (e.g., inner) elongate member coupled to the distal multi-lumen drain. In the case where the distal multi-lumen drain is a reversible distal multi-lumen drain, the distal multi-lumen drain will be inverted as it is retracted into the elongate member.

[0161]

[0201] In some embodiments, after retracting the distal multi-lumen drain from the body region, negative pressure is optionally maintained within the body region for a period of time 1909. In certain circumstances, this may help to contract the body region and reduce bleeding, such as uterine bleeding in some postpartum situations.

[0162]

[0202] As mentioned, any of the surgical drain devices described herein may include a connector for quickly and securely (but releasably) connecting the distal multi-lumen drain structure to a negative pressure source. For example, any of these devices may include a sealing connector (also referred to as a sealing cap in some embodiments). For example, FIGS. 20A-20B depict another embodiment of a portion of a surgical drain device including a removable sealing cap. In this embodiment, the surgical drain device may include a plug assembly, which is not shown in FIGS. 20A-20B for simplicity. The sealing connector 2000 in this embodiment is shown as connected to (or may be integral with) the proximal end of the surgical drain device. The surgical drain device includes an elongate member formed as a flexible polymeric outer tube shaft 2003 and an inner hollow shaft polymeric inner shaft tube 2007. The distal end regions of each of the inner tube 2007 and outer tube 2003 are attached to the end of a distal multi-lumen drain, which in this embodiment is configured as a rolling drain 2005. The sealing connector on the proximal end of the device can fit onto (e.g., over, or in some embodiments, into) the proximal end of the inner shaft tube 2007, such that the lumen of the inner shaft tube is aligned with the aspiration lumen connected to the connector's port. An inner cap seal 2011 can create a sealed connection over and / or into the inner shaft tube. The sealing connector shown in FIGS. 20A-20B further includes an outer sealing region configured as a ring gasket 2001 configured to seal onto the outer shaft tube 2003, as shown in FIG. 20B. By distally advancing the proximal end of the inner tubular shaft (to which the sealing connector is attached), the sealing connector is inserted into the outer catheter, and the cap is sealed to the outer catheter, as shown in FIG. 20B. In FIG. 20A, the distal multi-lumen drain is configured as a rolling drain 2005 and is shown in an undeployed (e.g., retracted) configuration.Figure 20B shows the rolling drain 2005' in a fully deployed state, so that, as described above, the tubular mesh is fully extended from the device and negative pressure (e.g., vacuum) is applied through the device and distributed into the body lumen by the two-layer cylindrical mesh structure of the rolling drain. In Figures 20A-20B, the negative pressure tubing 2013 is connected to a pressure connector so that pressure is applied out of the rolling drain through the lumen of the inner shaft 2007.

[0163]

[0203] 21A-21B show another embodiment of a sealing connector 2100, similar to that shown in FIGS. 20A-20B, that couples to the proximal end of the device. In FIG. 21A, the sealing connector (e.g., sealing cap) 2100 is coupled to a vacuum source; in this embodiment, a vacuum port 2113 on the sealing connector couples to vacuum tubing 2113. As the inner member is advanced distally, a rolling drain 2105 extends from an indwelling configuration (shown in FIG. 21A) to a deployed configuration (shown in FIG. 21B). In this embodiment, the sealing connector 2100 includes an inner sealing surface 2111 configured to match the inner diameter of the tubular outer shaft 2103 to form a seal. As in FIGS. 20A-20B, the sealing connector may include one or more gaskets (e.g., ring gasket 2001) to help form and / or maintain the seal. The sealing connector (e.g., sealing cap) may further be adapted to couple to an inner rigid shaft or member 2123 (e.g., an inner rigid rolling drain deployment shaft). As shown in FIG. 21B, distally advancing 2122 the sealing connector relative to the outer shaft 2003 results in both extension / deployment of the distal multi-lumen drain structure (e.g., rolling drain) 2105 and sealing the negative pressure port 2113 in communication with the lumen of the tubular outer shaft, allowing suction to be applied through the flexible distal multi-lumen drain structure.

[0164]

[0204] FIGS. 22A-22B depict another embodiment of a surgical drain device showing a sealing connector (sealing cap 2200). The sealing connector in this embodiment is configured to connect and seal over the outer shaft of an elongate member 2203 and further proximally connect to a source of negative pressure at a vacuum port 2213. Accordingly, the sealing connector 2200 includes a tapered inner surface 2219 against which the proximal end of the outer shaft can mate to form a seal. The tapered inner surface may also include one or more gaskets (e.g., ring gasket 2301), as shown in FIGS. 23A-23B. In FIGS. 22A-22B, the sealing connector also couples to an inner elongate member 2223, which is proximally connected to one end of a distal multi-lumen drain structure (e.g., rolling type) 2205, 2205′. Thus, in this case, advancing the inner member 2223 as shown in Figure 23B will distally deploy a flexible distal multi-lumen drain structure (rolling drain). When a sealing connector is coupled to the inner member 2223, connecting 2222 the sealing connector to the exterior of the elongate outer shaft 2203 will deploy the rolling drain and connect the rolling drain at the distal end of the device to a suction source (negative pressure) at the proximal end of the device.

[0165]

[0205] FIGS. 23A-23B are similar to the embodiment shown in FIGS. 21A-21B. In this embodiment, the sealing connector 2300 also includes a negative pressure port 2313 for connection to a negative pressure source (e.g., via tubing) and an inner sealing surface 2319. In this embodiment, the inner sealing surface is not tapered but instead includes a pair of ring gaskets 2301 (although one or more ring gaskets may be used). The outer elongate shaft 2303 of the device may be inserted into an opening in the sealing connector to form a seal with the sealing connector within the opening. The sealing connector may optionally connect to the inner shaft 2223 in embodiments including a rolling drain 2205′ as described above. For example, advancing 2322 the sealing connector over the outer shaft 2303 as shown in FIG. 23B seals the inner lumen of the outer shaft in communication with the negative pressure port and, therefore, the negative pressure source. Any of the example devices shown in Figures 20A-20B, 21A-21B, 22A-22B, and 23A-23B may further include a plug assembly (not shown).

[0166]

[0206] Figures 24A-24F depict one embodiment of a sealing connector that can be used with any of the surgical drain devices described herein. In this embodiment, a sealing connector 2421 is shown coupled over the distal end of the device's outer shaft 2403, forming a seal between the sealing connector (and thus a negative pressure source coupled to the sealing connector's negative pressure port 2413) and the inner lumen of the outer shaft 2403. The exemplary device shown in Figures 24A-24F includes an inner shaft coupled to one end of a flexible distal multi-lumen drain member (not shown) so that the flexible distal multi-lumen drain member can be retracted and deployed.

[0167]

[0207] Any of these sealing connectors may further include a gripping region 2414 (e.g., a finger grip region) to facilitate handling of the connector when removing or mating it to the outer shaft. FIG. 24C shows an end view from the distal end of the device, including a suction lumen 2416 (also shown in FIGS. 24E and 24F). In this embodiment, the proximal end forms a negative pressure port 2413 and may be tapered to fit into tubing connected to a negative pressure source (e.g., a suction source). The cross-sectional view in FIG. 24F further shows the tapered inner surface of the distal opening for engaging the outer surface of the outer shaft 2403, and the deployment shaft engagement region 2418 for engaging the inner shaft as described above. In some embodiments, the deployment shaft engagement region is optional because the sealing connector is intended for use with devices that include a static (non-rolling) distal porous drainage member (described above and shown in the embodiments of Figures 32A-32C, 33A-33B, 34A-34B, 35, 36A-36B, 37A-37B, 41A-41C, and 42A-42B).

[0168]

[0208] 25A-25E depict another embodiment of a sealing connector (sealing cap) described herein. In this embodiment, the sealing connector 2500 (sealing cap) includes a negative pressure port 2513 at the proximal end for connection to a negative pressure source, a finger grip region 2514, and a distal engagement surface for sealing against the inner and / or outer elongate shaft of the device to connect the negative pressure source to the distal multi-lumen drain member. In FIG. 25A, the sealing connector 2500 is shown connected to the outer shaft 2503 of a surgical drain device by inserting the outer shaft inner 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 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 embodiment of the surgical drain device shown in Figures 25A-25E, the device includes an inner deployment shaft for deploying and retracting the distal multi-lumen drain member. The sealing connector may also include an optional inner deployment shaft engagement region 2518, as shown in Figure 25E. In general, the sealing connectors described herein may also be configured for use with static (non-rolling) distal multi-lumen drain members.

[0169]

[0209] As discussed in detail above, the surgical drain devices described herein may be configured to include a compressible and expandable, e.g., self-expanding, plug assembly. In some embodiments, the plug assembly may include an annular foam member extending at least partially around the outer surface of the elongate outer member of the device to seal or otherwise prevent air and / or fluid from passing out of the area being drained. For example, FIGS. 26A-26H depict side views of various embodiments of annular foam members. In FIG. 26A, the plug or a portion of the plug assembly may include a ring-shaped foam material (shown in side views in FIGS. 26A-26H) that is compressible and capable of self-expanding outward to provide an embolic force against the body area into which the plug is inserted. The plug assembly may include any suitable material, including a foam material. The foam material may be an open-cell foam 2651 material (FIG. 26A) or a closed-cell foam 2652 material (FIG. 26B). Thus, generally, in Figures 26C-26H, the typical foam 2658 material may be either an open-cell foam or a closed-cell foam. For example, Figure 26C shows a portion of a plug assembly including a fluid-impermeable material covering one side of the foam plug, e.g., the distal side. This configuration may help maintain a seal with the body passageway or passageway even when open-cell foam is used. In Figure 26D, the plug assembly includes a fluid-impermeable cover covering the opposite side (e.g., the proximal side) of the foam plug. In some cases, both sides (or all sides) of the foam plug may be covered. The cover may be a biocompatible polymer (e.g., silicone, latex, etc.). The cover material may have a relatively high durometer (e.g., about 30-45, about 40-60, etc., on the Shore 00 scale). As noted above, the foam may be a viscoelastic polyurethane foam or a low-resilience polyurethane foam. In some embodiments, the foam includes a barrier on one side while the other side is open (which can aid in compression / expansion in open cell foam).A plug assembly, which in some embodiments may include a foam ring, can be mounted onto the tubular body of the device, as described in detail above. In some embodiments, the plug assembly is mounted to the tube, and in some embodiments, the plug assembly may be slidable over the tube to allow for conformance to the patient's anatomy while still forming a plug. In some embodiments, the barrier material may be applied by spraying, dipping, painting, etc. The barriers 2653, 2653', 2655 may also be referred to as skins.

[0170]

[0210] In some embodiments, a barrier or covering 2565 on or around the foam 2658 subassembly of the plug may be a covering. The covering 2656 may be loosely applied, as shown in FIG. 26F, or may be tightly applied (e.g., attached) to the foam, as shown in FIG. 26H. In some embodiments, one or both lateral sides of the foam plug subassembly may be covered, as shown in FIG. 26G, which shows a partial covering 2662. The skin or covering materials described herein, particularly materials tightly attached to the surface of the foam material, may also help distribute embolic forces across the surface of the plug when the plug is inserted into a body region and deployed or available for deployment.

[0171]

[0211] 27A-27G depict device embodiments showing different plug assemblies formed with one or more plug subassemblies similar to those shown in FIGS. 26A-26H. Generally, plug subassemblies of different sizes (height, width, and / or thickness) and materials (including different foam materials) may be used, and these different plug subassemblies may be spaced at different intervals (or adjustably spaced) along the length of the device's outer shaft. For example, in FIGS. 27A-27G, each of the devices shown includes an outer shaft 2703 and a distal perforated drain structure configured as a rolling drain (a non-rolling distal perforated drain structure may alternatively be used) connected to an inner member (e.g., a hollow flexible polymer tubing inner shaft 2707). In FIG. 27A, the plug assembly 2732 includes multiple (e.g., five shown) rings or disks of foam 2758 arranged on the outer shaft with gaps or spaces between each ring or disk. In some embodiments, a covering or skin may be applied over all or part of these foam subassemblies.

[0172]

[0212] Figure 27B shows an embodiment of a device similar to that shown in Figure 27A, but without spaces between the foam plug subassemblies of the plug assembly 2732. In Figure 27C, the foam plug subassemblies are wider than those shown in Figures 27A-B, but are arranged as shown in Figure 27B. In Figure 27D, the foam 2758 subassemblies of the plug 2732 assembly have similar widths but different heights. Figure 27D shows an embodiment similar to that shown in Figure 27D, but with both different heights and different widths, where the foam 2758 subassemblies of the plug assembly 2732 are arranged with increasing height and width from distal to proximal. Figures 27E and 27F show an arrangement of foam 2758 subassemblies in which the height of the foam subassemblies increases to a maximum and then decreases along their length in the proximal-distal direction, with the arrangement being symmetrical in Figure 27E, while in Figure 27G, the foam 2758 subassemblies have a wider width proximal to the plug assembly 2732.

[0173]

[0213] FIG. 28 illustrates an embodiment in which the foam subassemblies of the plug assembly 2832 have different mechanical properties. For example, in FIG. 28, the plug 2832 includes a proximal-most foam subassembly 2859 formed from a soft foam material, while each adjacent foam subassembly has a decreasing softness. For example, the middle foam subassembly 2859' is a medium-firm foam material, and the distal-most foam subassembly 2859'' is a firm foam material. The plug 2832 is disposed on the outer shaft 2803 of the device. This embodiment further includes a distal porous drain structure 2805' configured as a rolling drain and including an inner member 2807, although a non-rolling distal porous drain structure may alternatively be used.

[0174]

[0214] In some embodiments, it may be beneficial to secure the plug assembly (or portions of the plug assembly, such as the foam subassembly) to the shaft of the outer member and / or to each other. In some cases, adhesive materials may be used. For example, FIGS. 29A-29B, 30A-30B, and 31A-31D depict different embodiments of the device using adhesive to secure the foam subassembly forming the plug assembly to the outer shaft of the device. These embodiments also include a distal porous drain structure 2905′, 3005′ configured as a rolling drain and including an inner member 2907, 3007, although non-rolling distal porous drain structures may alternatively be used.

[0175]

[0215] The adhesive material may be applied as a tape adhesive, a liquid (e.g., polymeric) adhesive, etc. In Figure 29A, adhesive 2964, 2964' extends from the shaft of the outer elongate shaft 2903 over and along a portion of both the proximal and distal surfaces of the foam subassembly 2959. Figure 29B shows a similar embodiment in which plug assembly 2932 includes multiple (e.g., two, or in some embodiments more) foam subassemblies 2959 adhesively secured to the shaft of elongate outer shaft 2903, with the proximal surface of the proximal-most foam subassembly adhesively secured to the distal surface of the distal-most foam subassembly, and with each foam subassembly adhesively secured to (e.g., between) adjacent foam subassemblies.

[0176]

[0216] In some embodiments, the extent of the adhesive may differ between the proximal and distal surfaces of the foam subassembly or subassemblies 3064 forming the plug assembly 3032. In FIG. 30A, the adhesive 3064 on the proximal surface is more extensive (e.g., extends over all or most of the proximal surface) than the adhesive 3064' on the distal surface. In FIG. 30B, this arrangement is reversed. In both cases, the adhesive 3064, 3064' secures the foam subassembly 3059 of the plug assembly 3032 to the outer shaft 3003.

[0177]

[0217] 31A-31D show end views (e.g., looking proximally from the distal end) of different embodiments of adhesive applied to the end face of the foam subassembly. In each embodiment, adhesive 3164 is applied around and to the shaft 3171 (e.g., outer shaft) and to the face of the foam subassembly 3159. In FIG. 31A, the adhesive 3164 is arranged in a single bar-like configuration. In FIG. 31B, the adhesive 3164 is arranged in a plus (+) shaped configuration. In FIG. 31C, the adhesive 3164 is arranged in a circular configuration having a radius smaller than the radius of the foam subassembly 3159, while in FIG. 31D, the adhesive 3164 has the same radius as the foam subassembly 3159.

[0178]

[0218] As mentioned above, any of the devices described herein may be configured such that the distal multi-lumen drain structure is static or non-deployable, but may otherwise have the same or similar structure, except that the inner member need not extend or retract the distal multi-lumen drain structure. FIGS. 32A-32C schematically depict one embodiment of a surgical drain device described herein, in which the distal multi-lumen drain structure 3282 is formed from an inverted tube of flexible porous material (e.g., mesh or other woven material, including knitted, woven, and / or braided materials) that is inverted (inside out) upon itself. In any of these embodiments, the use of two or more layers of porous material, such as mesh, can be particularly helpful in distributing suction within the body lumen to prevent suction locking. An inverted two-layer tube of material may be configured as shown in FIG. 32A, whereby both the first and second ends of the tubular material 3282 are attached to the outer shaft 3203. The dimensions of the devices shown herein, including in Figures 32A-32C, are not intended to be exact and may vary. For example, the distal multi-lumen drain structure may extend over 1 to 15 inches (2.54 to 38.1 cm) or more (e.g., 1 to 14 inches (2.54 to 35.6 cm), 1 to 13 inches (2.54 to 33.0 cm), 1 to 12 inches (2.54 to 30.5 cm), 1 to 11 inches (2.54 to 27.9 cm), 1 to 10 inches (2.54 to 25.4 cm), 1 to 9 inches (2.54 to 22.9 cm), etc.). The distal multi-lumen drain structure may generally be flexible and compressible (e.g., capable of being compressed when inserted into a tissue region), but typically has sufficient column strength to allow it to be manually inserted into a body region without bending or collapsing. In some cases, a user may insert the non-rolling distal multi-lumen drainage structure into the body manually (using gloved hands). A device including a non-rolling distal multi-lumen drainage structure may include any of the plug assemblies described herein and / or may include the sealing connectors described above.

[0179]

[0219] For example, Figures 32A-32C depict an embodiment of a device having a non-rolling distal perforated drainage structure 3282 and a plug assembly 3232 similar to that shown and described above in Figures 27A-27C, where the plug assembly 3232 is formed from a plurality of foam subassemblies 3259 arranged along the outer shaft 3203. Similarly, Figures 33A-33B and 34A-34B show a device having a non-rolling distal perforated drainage structure 3382, 3482 with plug assemblies 3332, 3432 attached to the outer shaft 3303, 3403, each plug assembly being formed from a plurality of foam subassemblies 3359, 3459 arranged similarly to that shown in Figures 27D-27G.

[0180]

[0220] Similarly, Figures 35, 36A-36B, and 37A-37B show embodiments of surgical drain devices corresponding to Figures 28, 29A-29B, and 30A-30B, respectively, but having a non-rolling distal multi-lumen drain structure instead of a rolling distal multi-lumen drain structure (and thus no inner member). For example, the non-rolling distal multi-lumen drain structures 3582, 3682, 3782 may be formed by everting a porous mesh tubular material over itself at the distal surface and connecting both ends of the mesh tube to the outer shaft 3503, 3603, 3703 of the device to form a two-layered tube. In some cases, the mesh material may be knitted, woven, and / or braided. Any of these devices may further include a plug assembly 3532, 3632, 3732 including one or more foam subassemblies 3559, 3659, 3759 which may be adhesively secured to the outer shaft by an adhesive material 3664, 3664', 3764, 3764'.

[0181]

[0221] In some of the surgical drain devices described herein, the distal multi-lumen drain structure can include a distal multi-lumen drain structure configured as a rolling drain structure, where the inner member of the distal multi-lumen drain 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, FIGS. 38A-38C depict one embodiment of a surgical drain device in which the distal multi-lumen drain structure is formed of a tubular mesh material attached at one end to an outer shaft 3888 configured as a retractable sheath, and the opposite end region of the distal multi-lumen drain structure is attached to a hollow tubular inner shaft member 3807, 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 shown in FIG. 38A. In this embodiment, the distal multi-lumen drain structure has 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 deploy and / or align the distal multi-lumen drainage structure with the body region and create a suction flow path therethrough. Alternatively or additionally, the inner shaft member 3807 can be retracted proximally to create a two-layered tube of the distal multi-lumen drainage structure so that suction can be applied through the distal multi-lumen drainage structure. Figure 38B shows distal advancement of the outer member 3888, while Figure 38C shows proximal retraction of the inner member.

[0182]

[0222] Any of the devices described herein can include a plug configured to be actively controlled (e.g., collapsed and / or deployed). For example, any of the devices described herein can include a cover, such as a fluid-impermeable (fluid-barrier) cover, over the plug assembly. As depicted in FIGS. 39A-39B, in some embodiments, the cover can be used to controllably compress and / or release (e.g., allow deployment) the plug assembly. FIG. 39A shows a device including an outer shaft 3903, a distal perforated drain structure (configured as a rolling drain in this example, although a non-rolling drain may be used) 3905, a hollow inner shaft 3907, and a plug assembly 4032. The plug assembly includes a foam subassembly, shown, for example, as a compressible, self-expanding cylinder / disc of foam 3959 with a channel through which the outer shaft can pass. The plug assembly further includes a shroud 3982 attached to the outer shaft distally 3958 and slidably coupled over the outer shaft proximally 3957. Pulling the proximal end 3957 of the shroud compresses / collapses the plug assembly proximally, as shown in FIG. 39B. Releasing the shroud and allowing it to slide distally redeploys the plug assembly (as shown in FIG. 39A).

[0183]

[0223] The covering 3982 may completely or partially cover the compressible / self-expanding subassembly. In some embodiments, the covering may be one or more straps, as shown in FIGS. 40A-40B. In FIG. 40A, the surgical drain device includes an outer shaft 4003, a distal perforated drain structure (shown as a rolling drain, although a non-rolling drain may be used) 3905, an inner shaft 4007, and a plug assembly 4032. As in FIGS. 39A-39B, the plug assembly includes a compressible / self-expanding foam subassembly 4059. In this embodiment, multiple straps 4083, 4083′, 4083″ are included as part of the plug assembly, each strap having a distal end 4058 attached to the outer shaft and a proximal end region slidably coupled to the outer shaft. Sliding the proximal end 4057 proximally (to the left in FIGS. 40A-40B) pulls the straps and places them under tension, collapsing the plug assembly 4059 as shown in FIG. 40B, and releasing the proximal end 4057 of the strap allows the plug subassembly to self-deploy as shown in FIG. 40A. The proximal end region of the shroud (either the full shroud or one or more straps) may be connected to a ring or other slider that slides on the outer shaft and / or is adapted to be grasped by the user's hand.

[0184]

[0224] In some embodiments described herein, the plug assembly may be configured to be removed from the body by folding the covering and / or one or more straps (e.g., at the end of a procedure). Alternatively, in some embodiments, the plug assembly may be removed by controllably disassembling the plug assembly so that it collapses and / or is retracted from the flow passage. For example, FIGS. 41A-41C depict embodiments of a plug assembly configured to be removed from the body by pulling a tether (e.g., a string, line, etc.). FIG. 41A shows an embodiment of a device including an outer shaft 4103, a distal porous drain structure 4182 (shown as a non-rolling drain, but which may alternatively be a rolling drain), and a plug assembly 4032 formed of a compressible / self-expanding foam plug subassembly 4191. A pull tether 4195 is attached to a proximal portion of the plug assembly. Pulling the pull tether 4195 peels and collapses the plug assembly. In some embodiments, the plug assembly is formed from multiple plug subassemblies connected to adjacent compressible / self-expanding foam plug subassemblies at a single, discrete point, as shown in FIG. 41B. In FIG. 41B, pulling the pull tether 4195 in a proximal direction as shown pulls the plug assemblies apart, resulting in the individual plug assemblies breaking apart. Alternatively, in some embodiments, the plug assembly may be formed from a helical-shaped subassembly 4191 that can unravel the plug assembly when its proximal end is pulled proximally by the pull tether 4195, as shown in FIG. 41C.

[0185]

[0225] In some embodiments, the plug assembly is folded by changing the configuration of the plug assembly from a raised configuration, in which one or more plug subassemblies extend out from the outer shaft, to a folded configuration, in which an arrangement of one or more plug subassemblies is arranged in a lower profile. In the variation shown in Figures 41A-41C, the plug assembly can be folded or reduced in radial diameter without compressing the material forming the plug assembly, although it may also be compressed.

[0186]

[0226] For example, in FIGS. 42A-42B , the device includes an outer shaft 4203, a distal perforated drain structure 4282 (optionally configured as a static or non-rolling drain), and a plug assembly 4232. The plug assembly further includes a proximally extending tether 4203. In FIG. 42A , the plug assembly is shown in a radially expanded, raised configuration. The plug assembly in this embodiment is formed of a foam material attached to the outer shaft along a first region, where the foam material is tucked under itself (e.g., double-overlapped). A tether is connected to the tucked region such that pulling the tether proximally unwinds the foam material, allowing it to lie flatter against the exterior of the outer shaft, as shown in FIG. 42B . In some embodiments, the plug subassembly is everted upon itself to form a raised configuration, and can be uneverted to a flatter configuration by pulling the tether proximally.

[0187]

[0227] Any of the methods (including the user interface) described in the specification may be implemented as software, hardware, or firmware, and may be described as a non-transitory computer-readable storage medium having stored thereon a set of instructions executable by a processor (e.g., a computer, a tablet, a smartphone, etc.) that, when executed by the processor, cause the processor to control the performance of any of the steps, including, but not limited to, displaying, communicating with a user, analyzing, modifying parameters (including timing, frequency, intensity, etc.), determining, alerting, etc.

[0188]

[0228] It is understood that all combinations of the foregoing concepts, and additional concepts discussed in more detail below, provided that such concepts are not mutually inconsistent, are considered to be part of the inventive subject matter disclosed herein and may be used to realize the benefits described herein.

[0189]

[0229] When a feature or element is referred to herein as being "on" another feature or element, it may be directly on the other feature or element, or there may be intervening features and / or elements 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 should also be understood that when a feature or element is referred to as being "connected," "attached," or "coupled" to another feature or element, it may be directly connected, attached, or coupled to the other feature or element, or there may be intervening features or elements 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 features and elements may be described or illustrated with respect to one embodiment, the features or elements so described or illustrated may be applicable to other embodiments. As will be understood by those skilled in the art, when a structure or feature is referred to as being located "adjacent" to another feature, the structure or feature may have an overlapping or underlying portion with the adjacent feature.

[0190]

[0230] The terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit the invention. For example, as used herein, the singular articles "a," "an," and "the" (e.g., "a certain," "an," and "the") are intended to include the plural, unless the context clearly dictates otherwise. It should be further understood that the terms "comprises" and / or "comprising," when used herein, indicate the presence of stated features, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and / or groups thereof. As used herein, the term "and / or" includes any and all combinations of one or more of the associated listed items and may be abbreviated as " / ."

[0191]

[0231] Spatial relationship terms such as "below," "below," "lower," "above," "upper," and the like may be used herein for ease of description when describing the relationship of one element or feature illustrated in the figures to another element(s) or feature(s). It is understood that spatial relationship terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if a device in the figures were inverted, an element described as "below" or "behind" the other element or feature would be oriented "above" the other element or feature. Thus, the illustrative term "below" may encompass both an up and down orientation. The device may be otherwise oriented (e.g., rotated 90 degrees or at another orientation), and the spatial relationship descriptors used herein may be interpreted accordingly. Similarly, terms such as "upward," "downward," "vertical," "horizontal," and the like are used herein for descriptive purposes only, unless expressly indicated otherwise.

[0192]

[0232] The terms "first" and "second" may be used herein to describe various features / elements (including steps), and these features / elements are not limited by these terms unless the context dictates otherwise. These terms may be used to distinguish one feature / element from another. Thus, a first feature / element discussed below could be referred to as a second feature / element, and similarly, a second feature / element discussed below could be referred to as a first feature / element, without departing from the teachings of the present invention.

[0193]

[0233] Throughout this specification and the appended claims, unless the context requires otherwise, the word "comprises" and variations such as "comprises" and "comprising" mean that various components may be jointly employed in methods and articles (e.g., apparatuses, including compositions and devices, and methods). For example, it should be understood that the term "comprising" implies the inclusion of any stated element or step, but not the exclusion of any other element or step.

[0194]

[0234] Generally, the apparatus and methods described herein should be understood to be inclusive, although all or a subset of the components and / or steps may alternatively be exclusive, and may be expressed as "consisting of" or alternatively "consisting essentially of" various components, steps, subcomponents, or substeps.

[0195]

[0235] As used in this specification and claims, including in the examples, unless clearly indicated otherwise, all numbers may be read as if preceded by "about" or "approximately," even if such words do not explicitly appear. The terms "about" or "approximately," when describing a size and / or location, may be used to indicate that the stated value and / or location is within a reasonably expected range of value and / or location. For example, a numerical value may have a value that is + / - 0.1% of the stated value (or range of values), + / - 1% of the stated value (or range of values), + / - 2% of the stated value (or range of values), + / - 5% of the stated value (or range of values), + / - 10% of the stated value (or range of values), etc. Any numerical value given herein should also be understood to include about or approximately that value, unless the context dictates otherwise. For example, if the value "10" is disclosed, then "about 10" is also disclosed. Any numerical range recited herein is intended to include all subranges subsumed therein. Similarly, when a value is disclosed, it is understood that "less than or equal to" the value, "greater than or equal to" the value, and possible ranges between values, as would be appropriately understood by one of ordinary skill in the art, are also disclosed. For example, if a value of "X" is disclosed, "less than or equal to X" as well as "greater than or equal to X" (e.g., where X is a numeric value) are also disclosed. It should be further understood that throughout the application, data is provided in a number of different formats, and this data expresses endpoints and starting points and ranges for any combination of the data points. For example, if a specific data point of "10" and a specific data point of "15" are disclosed, it is understood that greater than 10 and 15, greater than or equal to 10 and 15, less than 10 and 15, less than 10 and 15, and equal to 10 and 15 are also considered disclosed, as are values ​​between 10 and 15. It is also understood that each unit between two specified units is disclosed. For example, if 10 and 15 are disclosed, then 11, 12, 13, and 14 are also disclosed.

[0196]

[0236] While various illustrative embodiments have been described above, any of numerous modifications may be made to the various embodiments without departing from the scope of the invention as set forth in the claims. For example, the order in which various described method steps are performed may often be changed in alternative embodiments, and one or more method steps may be omitted entirely in other alternative embodiments. Optional features of the various device and system embodiments may be included in some embodiments and not in others. Accordingly, the foregoing description has been provided primarily for illustrative purposes and should not be construed as limiting the scope of the invention as set forth in the claims.

[0197]

[0237] The examples and illustrations contained herein are intended to illustrate, by way of example, and not limitation, specific embodiments in which the subject matter may be practiced. As stated, other embodiments may be utilized and derived therefrom, resulting in structural and logical substitutions and changes being possible without departing from the scope of this disclosure. Such embodiments of the inventive subject matter may be referred to herein individually or collectively by the term "invention," merely for convenience and without any intention of intentionally limiting the scope of this application to any single invention or inventive concept when in fact more than one invention or inventive concept is disclosed. Thus, while specific embodiments have been illustrated and described herein, any arrangement calculated to achieve the same purpose may be substituted for the specific embodiment shown. This disclosure is intended to cover any and all adaptations or variations of the various embodiments. Combinations of the above embodiments and other embodiments not specifically described herein will be apparent to those of skill in the art upon reviewing the above description. [Explanation of symbols]

[0198] 100 Surgical drainage device 102 Slender members 103 Elongated introducer member 104 lumens 106 Distal multi-hole drain 111 Lumen of distal multi-hole drain 120 Cavity 122 Channel 202 Slender Members 206 Tubular Distal Multi-Located Drain 212 Slender Members 216 Tubular Distal Multi-Lubricated Drain 222 Slender Members 226 Tubular Distal Multi-Lubricated Drain 232 Slender Members 236 Tubular Distal Multi-Lubricated Drain 242 Slender Members 246a, 246b Tubular distal multi-hole drain 302 Slender members 306 Tubular Distal Multi-Hole Drain 308 Outer porous wall 309 Inner Space 311 Inner porous wall 312 Slender Members 316 Tubular Distal Multi-Hole Drain Structure 317 Sheath 322 Slender Members 325 Opening 326 Tubular Distal Multi-Lubricated Drain 326 327 Sheath 329 Inner Space 332 Slender Members 336 Tubular Distal Multi-Lubricated Drain 337 Sheath 339 Inner Space 342 Slender Members 345a, 345b slit 346 Tubular Distal Multi-Lubricated Drain 347 Sheath 349 Inner Space 406 Tubular Distal Multi-Located Drain 412 Slender members 416 Tubular Distal Multi-Hole Drain 422 Slender members 426 Non-tubular distal multi-hole drain 432 Slender Members 436 Distal multi-hole drain 441 Second slender member 442 first elongated member 446 Reversible Distal Multi-Located Drain 502 Slender members 506 Tubular Distal Multi-Hole Drain 509 Inner Space 516, 555 Porous wall 550 Fluid and / or Gas Flow 600 equipment 602 second elongated member 603 First elongated member 606 Reversible tubular distal multi-hole drain 607 1st end 609 2nd end 611 First Lumen 621 Second Lumen 628 Third Lumen 700 equipment 702 second elongated member 703 First elongated member 706 Distal multi-hole drain 720 Cavity 722 Channel 730 plug 802 second elongated member 803 First elongated member 806 Distal multi-hole drain 830 Plug Assembly 833 Cover 838 Proximal Connector 839 Distal Connector 842 vacuum port 930 Plug Assembly 932 Proximal Connector 933 Cover 934 Elastic Body 1003 Slender members 1030 Plug Assembly 1031 - predetermined angle between elastic body 1034 and elongated member 1003 1032 Proximal lateral surface 1033 Compressed Layer 1034 Elastic body 1036 Fluid Barrier Layer 1038 Second Connector 1039 First Connector 1130 Plug Assembly 1132 Second connector, handle 1133 Compressed Layer 1134a, 1134b, 1134c Elastic body 1136 Fluid Barrier Layer 1138 First Connector 1140, 1141 Washers 1203 Slender members 1230 Plug Assembly 1232 Handle 1233 Compressed Layer 1234 Elastic body 1236 Fluid Barrier Layer 1238 Second Connector 1239 First Connector 1240 Stopper 1303 Slender members 1330 Plug Assembly 1332 Handle 1333 Compressed Layer 1334 Elastic body 1336 Fluid Barrier Layer 1338 Second Connector 1402 second elongated member 1403 Slender members 1406 Distal multi-hole drain 1430 Plug Assembly 1432 Handle 1433 Compression Layer 1434 Elastic body 1436 Fluid Barrier Layer 1501 Central opening 1555 Slits or openings 1602 Second elongated member 1603 First elongated member 1606 Tubular Distal Multi-Lubricated Drain 1700 Surgical Drainage Device 1702 first elongated member 1703 Second slender member 1706 Reversible distal multi-hole drain structure, distal multi-hole drain 1730 Plug 1732 Plug Handle 1738 Second Connector 1739 First Connector 1800 Surgical Drain Device 2000 Sealed Connector 2001 Ring Gasket 2003 Outer tube shaft 2005 Rolling Drain 2005' Fully deployed rolling drain 2007 Inner Shaft Tube 2011 Inner Cap Seal 2013 Negative Pressure Tube 2100 Sealed Connector 2103 Tubular outer shaft 2105 Rolling Drain 2111 Inner sealing surface 2113 Negative pressure port, negative pressure tubing 2122 advancing the sealing connector distally. 2123 Inner rigid shaft or member 2200 Sealing connector (sealing cap) 2203 Slender members 2205, 2205' Distal multi-hole drain structure 2213 Negative pressure port 2219 Tapered inner surface 2222 Connecting a sealing connector to the outside of the elongated outer shaft 2223 Long, slender inner member 2300 Sealed Connector 2301 Ring gasket 2303 Outer slender shaft 2313 Negative pressure port 2319 Inner sealing surface 2322 The process of advancing the sealing connector over the outer shaft. 2403 Outer shaft 2413 Negative Pressure Port 2414 Grasping area 2416 Suction lumen 2418 Deployment shaft engagement region 2421 Sealed Connector 2500 Sealed Connector 2503 Outer Shaft 2513 Negative Pressure Port 2514 Finger grip area 2516 suction lumen 2518 Internally deployed shaft engagement region 2524 Outer sealing surface 2651 Open-cell foam 2652 Closed-cell foam 2653, 2653', 2655 barrier 2656 Cover 2658 Foam 2662 Partial Cover 2703 Outer shaft 2707 Inner member, hollow soft polymer tube inner shaft 2732 Plug Assembly 2758 Foam 2803 Outer shaft 2805' Distal multi-hole drain structure 2807 Inner member 2832 Plug Assembly 2859 Proximal-most Foam Subassembly 2859' Intermediate Foam Subassembly 2859'' Distal-most Foam Subassembly 2903 Outer elongated shaft 2905' Distal multi-hole drain structure 2907 Inner member 2932 Plug Assembly 2959 Foam Subassembly 2964, 2964' adhesive 3003 Outer Shaft 3005' Distal multi-hole drain structure 3007 Inner member 3032 Plug Assembly 3059 Foam Subassembly 3064 Proximal adhesive 3064' Distal adhesive 3159 Foam Subassembly 3164 Adhesive 3171 Shaft 3203, 3303, 3403, 3503, 3603, 3703 Outer shaft 3232, 3332, 3432, 3532, 3632, 3732 Plug Assembly 3282, 3382, 3482, 3582, 3682, 3782 Non-rolling distal multi-hole drain structure 3259, 3359, 3459, 3559, 3659, 3759 Foam Subassemblies 3664, 3664', 3764, 3764' adhesive materials 3807 Inner shaft member 3888 Outer (e.g., sheath) member 3903 Outer Shaft 3905 Distal multi-hole drain structure 3907 Inner Shaft 3957 proximal 3958 distal 3959 Foam 3982 Cover 4003 Outer Shaft 4007 Inner Shaft 4032 Plug Assembly 4057 Proximal end of strap 4059 Compressible / Self-Expanding Foam Subassembly 4083, 4083', 4083'' straps 4103 Outer shaft 4182 Distal multi-hole drain structure 4191 Compressible / Self-Expanding Foam Plug Subassembly 4195 Pull Tether 4203 Outer shaft 4232 Plug Assembly 4282 Distal multi-hole drain structure

Claims

1. 1. A surgical drain device comprising: a first elongated shaft; a second elongated shaft having an aspiration lumen extending therethrough, the second elongated shaft configured for axial movement within the first elongated shaft; a distal multi-lumen drain extending distally from the distal end regions of the first elongate shaft and the second elongate shaft, the distal multi-lumen drain comprising two or more layers of porous material surrounding a central lumen in fluid communication with the aspiration lumen; a compressible self-expanding plug assembly on an outer surface of the first elongate shaft; A surgical drainage device comprising:

2. 10. The apparatus of claim 1, The two or more layers of porous material comprise a mesh.

3. 10. The apparatus of claim 1, The device, wherein the two or more layers of porous material comprise knitted, woven, or braided material.

4. 10. The apparatus of claim 1, The two or more layers of porous material comprise a nonwoven porous sheet of material.

5. 10. The apparatus of claim 1, The two or more layers of porous material comprise an everted mesh tube having a first end connected to the first elongate shaft and a second end connected to the second elongate shaft.

6. 10. The apparatus of claim 1, A device wherein the distal multi-lumen drain is tubular and has two or more concentric cylindrical mesh walls.

7. 10. The apparatus of claim 1, The device, wherein the central lumen opens into a distal end region of the distal multi-lumen drain.

8. 10. The apparatus of claim 1, The device, wherein the distal multi-lumen drain is a non-tubular structure.

9. 10. The apparatus of claim 1, The device, wherein the plug assembly comprises an elastic body, a deployable mesh configured to radially compress the elastic body, and a fluid barrier membrane.

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

11. 10. The apparatus of claim 1, The device, wherein the distal multi-lumen drain is configured to be compressed along its distal-proximal length.

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

13. 10. The apparatus of claim 1, The device further comprises a suction connector having a suction port at a proximal end and a releasable connector portion at a distal end, the releasable connector portion configured to couple to the first elongate shaft.

14. 10. The apparatus of claim 1, The compressible self-expanding plug assembly comprises a viscoelastic foam.

15. 10. The apparatus of claim 1, The device wherein the distal multi-lumen drain has a diameter greater than 2 cm in a relaxed state.

16. 10. The apparatus of claim 1, the distal multi-lumen drain is configured to extend out from and retract into the first elongate shaft as the second elongate shaft is moved axially relative to the first elongate shaft.

17. 10. The apparatus of claim 1, The device further comprises a stopper that limits axial movement of the second elongate shaft relative to the first elongate shaft to prevent the second elongate shaft from extending distally out from the first elongate shaft.

18. 1. A surgical drain device comprising: a first elongated shaft; a second elongated shaft having an aspiration lumen extending therethrough, the second elongated shaft configured for coaxial movement relative to the first elongated shaft; a distal multi-lumen drain comprising an evertable tube having a first end connected to the distal end region of the first elongate shaft and a second end connected to the distal end region of the second elongate shaft so as to comprise two or more adjacent layers of mesh surrounding a central lumen in fluid communication with the aspiration lumen; a compressible self-expanding plug assembly on an outer surface of the first elongate shaft; A surgical drainage device comprising:

19. 1. A surgical drain device comprising: a first elongated shaft; a second elongate shaft having an aspiration lumen extending therethrough; a distal multi-lumen drain extending distally from the distal end regions of the first elongate shaft and the second elongate shaft, the distal multi-lumen drain comprising a mesh tube inverted upon itself to form an adjacent cylindrical layer surrounding a central lumen in fluid communication with the aspiration lumen; a compressible self-expanding plug assembly on an outer surface of the first elongate shaft; A surgical drainage device comprising:

20. 1. A method of draining a body area, comprising the steps of: positioning a distal multi-lumen drain within the body region, the distal multi-lumen drain extending distally from a first elongate shaft and a second elongate shaft coaxial with the first elongate shaft, the distal multi-lumen drain comprising two or more concentric layers of flexible porous material surrounding a central lumen in fluid communication with an aspiration lumen extending through the first elongate shaft; creating a seal around the first elongated shaft to maintain a vacuum within the body region; applying negative pressure through the aspiration lumen such that multiple flow paths are created through and between two or more concentric layers of the porous material along the length of the distal porous drain; A method for providing the above.

21. 21. The method of claim 20, The method wherein the two or more concentric layers of porous material comprise a mesh material.

22. 21. The method of claim 20, The method wherein the distal multi-lumen drain is attached at a first end to the first elongate shaft and at a second end to the second elongate shaft.

23. 21. The method of claim 20, The method further comprises maintaining suction as the distal multi-lumen drain is compressed by the body region.

24. 21. The method of claim 20, wherein positioning the distal multi-lumen drain within the body region comprises distally advancing the second elongate member to extend the distal multi-lumen drain distally out of the first elongate shaft and distally of the second elongate member into the body region.

25. 21. The method of claim 20, The method further comprises maintaining the negative pressure within the body region after retracting the distal multi-lumen drain from the body region.

26. 21. The method of claim 20, The method, wherein creating the seal comprises deploying a plug assembly coupled to the first elongate shaft into a body passageway leading to the body region.

27. 27. The method of claim 26, The plug assembly is disposed about an outer surface of the first elongated shaft.

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

29. 27. The method of claim 26, The method further comprising the step of radially compressing the plug assembly prior to the step of positioning the plug assembly within the body passageway.

30. 30. The method of claim 29, The method wherein radially compressing the plug assembly comprises pulling a compression layer covering an elastic body in a proximal direction, such that the compression layer is stretched and applies a radial compression force to the elastic body.

31. 21. The method of claim 20, further comprising the step of connecting the suction lumen to a suction source prior to the step of applying negative pressure.

32. 32. The method of claim 31 , The method, wherein connecting the suction lumen comprises releasably connecting the first elongate shaft to a suction connector having a friction fit connector portion for the first elongate shaft and a suction port configured to connect to a negative pressure source.

33. 1. A surgical drain device comprising: an elongate shaft having an aspiration lumen extending therethrough; a distal multi-lumen drain extending distally from the distal end region of the elongate shaft, the distal multi-lumen drain comprising two or more layers of porous material surrounding a central lumen in fluid communication with the aspiration lumen; a compressible, self-expanding plug assembly on the outer surface of the elongate shaft, the plug assembly being disposed about the outer surface of the elongate shaft and including an elastic body covered by a cover, the cover being arranged to apply a radial compressive force to the elastic body to radially compress the elastic body and to release the compressive force to allow the elastic body to resume its radially expanded state; and A surgical drainage device comprising:

34. 34. The apparatus of claim 33, The device, wherein the cover comprises a compressible layer and a fluid barrier layer, the compressible layer configured to apply the compressive force.

35. 35. The apparatus of claim 34, The device, wherein the compressible layer comprises an expandable mesh.

36. 34. The apparatus of claim 33, The cover is coupled to a slidable proximal connector configured to stretch the cover when driven distally, thereby generating a radial compressive force.

37. 37. The apparatus of claim 36, The device, wherein the slidable proximal connector is configured to apply an axial compressive force to the elastic body when driven distally, thereby stiffening the elastic body in the radially deployed state.

38. 37. The apparatus of claim 36, The plug assembly comprises a plurality of elastic bodies configured to slide axially relative to the elongate shaft, and the slidable proximal connector is configured to compress the plurality of elastic bodies together when driven distally.

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

40. 37. The apparatus of claim 36, The device, wherein the slidable proximal connector is configured to be manually activated.

41. 34. The apparatus of claim 33, The device, wherein the elastic body has flat sides that are oriented at a predetermined angle relative to the outer surface of the elongate shaft when the elastic body is in the radially deployed state.

42. 42. The apparatus of claim 41, The apparatus, wherein the predetermined angle is approximately 90 degrees.

43. 34. The apparatus of claim 33, The apparatus, wherein the elastic body is configured to flex radially inward when the radial compressive force is applied to the elastic body.

44. 34. The apparatus of claim 33, The device, wherein the cover is configured to twist relative to the elongate shaft.

45. 45. The apparatus of claim 44, The device, wherein the cover is coupled to a slidable proximal connector configured to rotate relative to the elongate shaft when driven proximally, thereby twisting the cover.

46. 34. The apparatus of claim 33, The device, wherein the elastic body is disposed at a distal end of the elongate shaft, and the distal multi-lumen drain is configured to exit the elongate shaft distally through the distal end of the elongate shaft.

47. 34. The apparatus of claim 33, The apparatus, wherein the elastic body comprises foam.

48. 34. The apparatus of claim 33, The device, wherein the plug assembly includes one or more locks configured to lock the resilient body in the radially deployed state.

49. 49. The apparatus of claim 48, The one or more locks are further configured to lock the elastic body in radial compression.

50. 34. The apparatus of claim 33, The device wherein the elastic body has a round radial cross section when in the radially deployed state.

51. 34. The apparatus of claim 33, The device wherein the elastic body has an oval radial cross-section when in the radially deployed state.

52. 34. The apparatus of claim 33, The device, wherein the elastic body has a rectangular axial cross-section when in the radially deployed state.

53. 34. The apparatus of claim 33, The device wherein the elastic body has a round axial cross section when in the radially deployed state.

54. 34. The apparatus of claim 33, The device wherein the elastic body has an oval axial cross-section when in the radially deployed state.

55. 1. A method of draining a body area, comprising the steps of: positioning a multi-lumen distal drain within a body region, the distal multi-lumen drain extending distally from an elongate shaft defining an aspiration lumen therethrough, the distal multi-lumen drain further comprising two or more layers of porous material surrounding a central lumen in fluid communication with the aspiration lumen; positioning a plug disposed about the elongate shaft into a body passageway leading to the body region, the plug including an elastic body covered by a cover, the plug being in a radially compressed state with the cover exerting a radial compressive force on the elastic body during the positioning step; creating a seal to maintain a vacuum within the body region by deploying the plug within the body passageway, wherein deploying the plug comprises releasing the radial compressive force exerted by the cover on the elastomer; applying negative pressure through the aspiration lumen such that multiple flow paths are created through and between two or more layers of porous material along the length of the distal porous drain; A method for providing the above.

56. 56. The method of claim 55, The method wherein the cover comprises a fluid barrier layer forming an outer skin over a portion of the plug.

57. 56. The method of claim 55, The method further comprises placing the plug in the radial compression state by proximally driving a slidable proximal connector to stretch the cover, thereby generating the radial compression force on the elastomer.

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

59. 58. The method of claim 57, The method, wherein creating the seal comprises stiffening the elastic body in a radially deployed state by distally driving the slidable proximal connector to apply an axial compressive force to the elastic body.

60. 60. The method of claim 59, The method, wherein the plug comprises a plurality of elastic bodies configured to slide axially relative to the elongate shaft, and the step of creating the seal comprises driving the slidable proximal connector distally to compress the plurality of elastic bodies together.

61. 58. The method of claim 57, The method, wherein driving the slidable proximal connector in the proximal direction comprises activating an actuator.

62. 58. The method of claim 57, The method, wherein driving the slidable proximal connector in the proximal direction comprises manually pulling a handle.

63. 56. The method of claim 55, The method, wherein the elastic body has flat sides that are oriented at a predetermined angle relative to the outer surface of the elongate shaft when the elastic body is in a radially deployed state.

64. 64. The method of claim 63, The method wherein the predetermined angle is about 90 degrees.

65. 56. The method of claim 55, The method wherein releasing the radial compressive force applied to the elastic body comprises untwisting the configured cover.

66. 56. The method of claim 55, The method wherein the elastic body comprises a foam or a sponge.

67. 56. The method of claim 55, The method, wherein creating the seal comprises locking the plug in a radially deployed state.

68. 56. The method of claim 55, The method further comprising locking the plug in radial compression.

Images