EP4615535A2 - Drains chirurgicaux et procédés d'utilisation - Google Patents

Drains chirurgicaux et procédés d'utilisation

Info

Publication number
EP4615535A2
EP4615535A2 EP23889480.2A EP23889480A EP4615535A2 EP 4615535 A2 EP4615535 A2 EP 4615535A2 EP 23889480 A EP23889480 A EP 23889480A EP 4615535 A2 EP4615535 A2 EP 4615535A2
Authority
EP
European Patent Office
Prior art keywords
distal
drain
elongate shaft
elastic body
porous drain
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP23889480.2A
Other languages
German (de)
English (en)
Inventor
E. Skott Greenhalgh
Jason KEISER
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Koko Medical Inc
Original Assignee
Koko Medical Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Koko Medical Inc filed Critical Koko Medical Inc
Publication of EP4615535A2 publication Critical patent/EP4615535A2/fr
Pending legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/84—Drainage tubes; Aspiration tips
    • A61M1/87—Details of the aspiration tip, not otherwise provided for

Definitions

  • Surgical drains are implants that allow removal of fluid (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 drain, that are believed to provide advantages not realized with other types of surgical drains.
  • surgical drains can help the healing process by removing inflammatory mediators, bacteria, foreign material, and necrotic tissue. Drains can relieve pressure that can impair perfusion or cause pain, thereby decreasing morbidity and reducing inflammation; they enable monitoring for potential complications by allowing easy sampling of fluid during healing; and they can be used to address complications associated with dead space. Active drains use intermittent or continuous negative pressure to pull fluid or gas from a wound or body cavity.
  • passive drains are open systems and active drains are closed systems because they rely on negative pressure that is created by the drain.
  • Negative pressure drains may be particularly helpful in treating postpartum uterine bleeding.
  • Postpartum uterine bleeding can occur when the uterine muscles are unable to achieve adequate contraction after delivery to cut off the blood flow that formerly circulated in the utero- placental space. The condition for this lack of contraction is called atony (lack of tone).
  • the uterine muscles typically cuts off the blood flow by contraction of the muscles to effectively pinch the arterial vessels that run through the tissue. In some cases, atony can result in arterial vessels that continue to bleed into the uterus (i.e., postpartum uterine bleeding).
  • Postpartum hemorrhage, or excessive uterine blood loss after birth is the leading cause of maternal death in the world.
  • the distal porous drain may communicate with an inner drain (e.g., a vacuum port coupled to a vacuum channel), so that the negative pressure is applied out of the distal porous drain. This may allow the distal porous drain to distribute negative pressure to a greater area and/or to create a larger surface area for fluid control.
  • the porosity of the distal porous drain e.g., the space between filaments in variations in which the distal porous drain if formed of knitted, woven or braided fibers
  • the porosity of the distal porous drain may be controllable.
  • the compressible and self-expanding plug assembly may comprise a viscoelastic foam.
  • the plug assembly may be self-expanding and manually compressible.
  • the plug may be configured to expand relatively slowly (e.g., over the course of tens of seconds or minutes), which may allow the user (physician, doctor, nurse, technician) to position or reposition the apparatus.
  • a method of draining a body region may include: positioning a distal porous drain into the body region, wherein the distal porous drain extends distally from an elongate member forming a suction lumen therethrough, further wherein the distal porous drain comprises two or more layers of porous material surrounding a central lumen that is 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 so that a plurality of flow paths are created through and between the two or more layers of porous material along a length of the distal porous drain.
  • 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.
  • any of these methods may include maintaining the suction as the distal porous drain is compressed by the body region. Any of these methods may include maintaining the negative pressure within the body region after withdrawing the distal porous drain from the body region.
  • creating the seal may comprise expanding a plug assembly coupled to the elongate member into a body channel that leads to the body region. The plug may be disposed around an outer surface of the first elongate member. Any of these methods may include locking the plug in a radially expanded configuration to maintain the seal. Any of these methods may include radially compressing the plug before positioning the plug within the body channel. For example, radially compressing the plug may comprise proximally pulling a compression layer covering an elastic body such that the compression layer elongates and applies a radial compression force on the elastic body.
  • the covering may comprise a compression layer and a fluid barrier layer, the compression layer configured to apply the compression force.
  • the compression layer comprises an expandable mesh.
  • the covering may be coupled to a slidable proximal connector configured to elongate the covering when driven distally, thereby creating the radial compression force.
  • the slidable proximal connector may be configured to apply an axial compression force on the elastic body when driven distally, thereby reinforcing the elastic body in the radially expanded state.
  • the plug assembly may comprise multiple elastic bodies that are configured to slide axially with respect to the first elongate member, wherein the slidable proximal connector is configured to compress the multiple elastic bodies together when driven distally.
  • the plug assembly may include an actuator configured to activate the slidable proximal connector.
  • the slidable proximal connector may be configured to be activate by hand.
  • the elastic body may be positioned at a distal end of the first elongate member, wherein the distal porous drain is configured to distally exit the first elongate member through the distal end of the first elongate member.
  • the elastic body comprises a foam.
  • the plug assembly may include one or more locks configured to lock the elastic body in the radially expanded 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 expanded state.
  • the elastic body may have an oblong radial cross section when in the radially expanded state.
  • the elastic body may have a rectangular axial cross section when in the radially expanded state.
  • the elastic body has a round axial cross section when in the radially expanded state.
  • the elastic body may have an oblong axial cross section when in the radially expanded state.
  • a method of draining a body region may include: positioning a distal porous drain into the body region, wherein the distal porous drain extends distally from an elongate member forming a suction lumen therethrough, further wherein the distal porous drain comprises two or more layers of porous material surrounding a central lumen that is in fluid communication with the suction lumen; positioning a plug that is disposed around the first elongate member into a body channel that leads to the body region, wherein the plug includes an elastic body covered by a covering, wherein the plug is in a radially compressed state during positioning of the plug in which the covering places a radial compression force on the elastic body; creating a seal to maintain a vacuum within the body region by expanding the plug within the body channel, wherein expanding the plug comprises releasing the radial compression force placed on the elastic body by the covering; and applying negative pressure through the suction lumen so that a plurality of flow paths are created through and between the two or more layers of porous material along a length
  • the distal porous drain may be a tube having porous walls.
  • the porous walls may terminate at the distal end of the distal porous drain.
  • the distal porous drain may be a nontubular structure.
  • the apparatus may further comprise a plug disposed around the first elongate member, wherein the plug is configured to expand radially outward to seal against soft tissue to fluidically isolate the distal porous drain within a soft tissue cavity.
  • the plug may comprise an elastic body, an expandable mesh that is configured to radially compress the elastic body, and a fluid barrier membrane.
  • the plug may comprise one or more locks configured to lock the plug in a radially expanded configuration, a radially compressed configuration, or the radially expanded configuration and the radially compressed configuration.
  • the distal porous drain may be configured to allow fluid to flow through the network of interconnected pores and out of a body cavity via the vacuum channel.
  • the vacuum channel may be within the lumen of the first elongate member, within a second lumen of the second elongate member, or within the lumen of the first elongate member and within the second lumen of the second elongate member.
  • the vacuum channel may be operationally coupled to a port at a proximal end region of the apparatus.
  • the apparatus may further comprise one or more seals between the first elongate member and the second elongate member.
  • the apparatus may further comprise one or more locks configured to lock a relative position of the first elongate member and the second elongate member.
  • a method of draining a body region comprising: positioning a distal porous drain into the body region, wherein the distal porous drain has a proximal end coupled to a distal end region of a second elongate member and a distal end freely extending from the second elongate member, the distal porous drain comprising a network of interconnected pores, wherein positioning the distal porous drain comprises advancing the second elongate member distally within a lumen of a 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 in a proximal direction via the network of interconnected pores.
  • the distal porous drain may be a tube having porous walls.
  • the porous walls may terminate at the distal end of the distal porous drain.
  • the distal porous drain may be a nontubular structure.
  • the method may further comprise withdrawing the second elongate member proximally to pull the distal porous drain into the lumen of the first elongate member.
  • the method may further comprise maintaining the negative pressure within the body region after withdrawing the distal porous drain from the body region. Positioning the distal porous drain into the body region may cause the distal porous drain to expand. Creating the seal may comprise expanding a plug into a body channel that leads to body region.
  • the plug may be disposed around the first elongate member.
  • the method may further comprise locking the plug in a radially expanded configuration to maintain the seal.
  • the method may further comprise radially compressing the plug before positioning the plug within the body channel. Radially compressing the plug may comprise proximally pulling a compression layer covering an elastic body such that the compression layer elongates and applies a radial compression force on the elastic body.
  • the method may further comprise locking the plug in a radially compresses state.
  • any of the apparatuses may include one elongate members or multiple elongate members (e.g., 2, 3, 4, 5 or more elongate members).
  • the elongate members may be nested (e.g., concentrically arranged) and be translatable (e.g., slidable) with respect to each other.
  • the distal porous drain and/or the plug may be coupled to a first (e.g., inner) elongate member, which may be slidably arranged within a lumen of a second (e.g., outer) elongate member.
  • the first elongate member may be pushed distally relative to the second elongate member (or the second elongate member may be pulled proximally relative to the first elongate member) to advance and/or expand the distal porous drain and/or the plug.
  • the first elongate member may be pulled proximally relative to the second elongate member (or the second elongate member may be pushed distally relative to the first elongate member) to retract and/or collapse the distal porous drain and/or the plug.
  • Such pulling and pushing may be actuated by manually gripping the first and/or second elongate members and sliding them relative to each other, or may be actuated by one or more actuators on a handle of the apparatus.
  • the elongate member includes a flexible and/or curved tube.
  • the elongate member may have a polymeric shaft that can be bent or curved to allow it to navigate bends within the anatomy.
  • the elongate member is pre-curved or pre-bent at one or more regions along its length.
  • the elongate member is steerable over all or a portion of its length.
  • the elongate member may include one or more tendons to allow steering.
  • the elongate member may be any appropriate length.
  • the elongate member may be between about 10 and 100 cm (e.g., between about 15 and 80 cm, between about 20 and about 50 cm, etc.).
  • the elongate member may be formed of a polymeric material and/or a metallic material.
  • any of the distal porous drains described herein may include a mesh that is a knitted, woven, or braided material.
  • the distal porous drain is a non-woven material (e.g., such as a sheet or layer of polymeric material through which pores of sufficient size to allow passage of fluids and biological debris (e.g., pus, coagulate, etc.) to pass without significant resistance.
  • the distal porous drain is a fabric.
  • the distal porous drain may be formed of a number of filaments (e.g., strands) of material, such as monofilaments or multiple filaments.
  • the distal porous drain may include a braided polymeric monofilament having 24 or more strands (e.g., 30 or more strands, 34 or more strands, 36 or more strands, 38 or more strands, 40 or more strands, 42 or more strands, etc.).
  • 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.
  • the distal porous drain may be expanded into an expanded configuration, as mentioned.
  • the distal porous drain is biased to expand into the expanded configuration.
  • the distal porous drain may be formed of a shape memory material (e.g., nitinol, etc.) that can be shape set to an expanded configuration in which the distal porous drain is expanded away from the second elongate member and/or first elongate member.
  • the distal porous drain has a tubular shape, and the apparatus is configured to invert the tubular distal porous drain.
  • One end of the invertible tubular distal porous drain may be connected to a first elongate member (e.g., tube) and the opposing end of the invertible tubular porous may be connected to a second elongate member (e.g., inner tube or rod).
  • the second elongate member may be sized and shaped to fit within a lumen of the first elongate member.
  • the invertible tubular distal porous drain may be extended within the body region by pushing the second elongate member.
  • the second elongate member is positioned within the first elongate member when the tubular distal porous drain is extended into the body region, which may cause the tubular distal porous drain to take on a double-walled tubular shape.
  • the invertible tubular distal porous drain may be removed from the body region by pulling the second elongate member, causing the tubular distal porous drain to invert and be fully drawn back into the first elongate member.
  • a surgical drain apparatus comprising: a first elongate member having a lumen; a second elongate member that is slidably disposed in the lumen; an invertible tubular distal porous drain having a first end coupled at a first end to a distal end region of the first elongate member and a second end coupled to a distal end region of the second elongate member, the invertible tubular distal porous drain comprising a network of interconnected pores, wherein the invertible tubular distal porous drain has an expanded configuration in which the invertible tubular distal porous drain has a double-walled tubular configuration and the second elongate member is fully withdrawn distally within the lumen of the first elongate member, wherein invertible tubular distal porous drain has a retracted configuration in which the invertible tubular distal porous drain is inverted and withdrawn into the lumen of the first elongate member; and
  • An axial position of the first elongate member may be configured to lock with respect to the second elongate member to lock the invertible tubular distal porous drain in the doublewalled tubular shape with the second elongate member fully withdrawn distally within the lumen of the first elongate member.
  • An axial position of the first elongate member may be configured to lock with respect to the second elongate member to lock the invertible tubular distal porous drain in the retracted configuration.
  • the apparatus may further comprise a plug disposed around the first elongate member, wherein the plug is configured to expand radially outward to seal against soft tissue to fluidically isolate the distal porous drain within a soft tissue cavity.
  • the plug may comprise an elastic body, an expandable mesh that is configured to radially compress the elastic body, and a fluid barrier membrane.
  • the plug may comprise one or more locks configured to lock the plug in a radially expanded configuration, a radially compressed configuration, or the radially expanded configuration and the radially compressed configuration.
  • the expandable mesh and the fluid barrier membrane may be coupled to a slidable proximal connector configured to elongate the expandable mesh when driven proximally, thereby creating a radial compression force on the elastic body.
  • the slidable proximal connector may be configured to apply an axial compression force on the elastic body when driven distally, thereby reinforcing the elongate body in a radially expanded state.
  • the plug assembly may comprise multiple elastic bodies that are configured to slide axially with respect to the first elongate member, wherein the slidable proximal connector is configured to compress the multiple elastic bodies together when driven distally.
  • Also described herein is a method of draining a body region, the method comprising: positioning an invertible tubular distal porous drain comprising a network of interconnected pores into the body region, the invertible tubular distal porous drain having a first end coupled at a first end to a distal end region of a first elongate member and a second end coupled to a distal end region of a second elongate member, the wherein the invertible tubular distal porous drain is in a double-walled tubular configuration and the second elongate member is fully withdrawn distally within a lumen of the first elongate member when the invertible tubular distal porous drain is positioned 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 in a proximal direction via the network of interconnected pores.
  • Positioning the invertible tubular distal porous drain into the body region may comprise: advancing the second elongate member distally to extend the second end of the invertible tubular distal porous drain into the body region; and retracting the second elongate member such that the distal end region of the second elongate member is withdrawn into the lumen of the first elongate member, wherein the invertible tubular distal porous drain folds to create the double-walled tubular configuration.
  • Positioning the invertible tubular distal porous drain into the body region may cause the invertible tubular distal porous drain to bend laterally as it contacts tissue walls.
  • the double- walled tubular configuration may define a central lumen in the invertible tubular distal porous drain, wherein applying suction in the proximal direction causes fluid from the body region to flow into the central lumen of the invertible tubular distal porous drain.
  • a distal end of the second elongate member may be axially positioned near a distal end of the first elongate member to maximize a length of the invertible tubular distal porous drain extending distally from the first elongate member in the double-walled tubular configuration.
  • Applying the negative pressure may comprise applying suction from a distal end of the first elongate member, from one or more openings of the second elongate member, or from the distal end of the first elongate member and the one or more openings of the second elongate member.
  • Creating the seal may comprise expanding a plug that is disposed around the first elongate member within a body channel that leads to the body region.
  • the plug may include an elastic body covered by a covering, wherein the plug is in a radially compressed state in which the covering places a radial compression force on the elastic body during positioning of the plug within the body channel, wherein expanding the plug comprises releasing the radial compression force placed on the elastic body by the covering.
  • the method may further comprise withdrawing the second elongate member proximally to invert the invertible distal porous drain as the invertible tubular distal porous drain is pulled into the lumen of the first elongate member.
  • the method may further comprise maintaining the negative pressure within the body region for a period of time after pulling the invertible tubular distal porous drain into the lumen of the first elongate member
  • the second elongate member may be formed as a solid member (e.g., a bar, rod, wire, etc.) or it 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.
  • the second elongate member typically has a smaller outer diameter (OD) than the inner diameter (ID) of the first elongate member, as the second elongate member is slidably disposed within 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. a plurality) of “stop” positions that may releasably hold the relative position of the second elongate member and the first elongate member.
  • the stop may be configured to hold the position of the second elongate member such that the second elongate member remains fully withdrawn within the first elongate member and an invertible tubular distal porous drain has a doublewalled configuration.
  • any of the apparatuses may include one or more expandable/contractible plugs (also referred to as occluders) that is/are integrated with the other portions of the apparatus (e.g., the elongate member) or separate from the other portions and configured to engage with the other portions of the apparatus.
  • the plug may form a seal between apparatus and the walls of a body region (e.g., a canal, channel or incision) so that the distal porous drain may be sealed within a body cavity being treated and so that negative pressure may be applied to drain the body cavity and/or to collapse the body cavity.
  • the plug may be radially expandable and collapsible so that it may be inserted within the body region in a collapsed state and expanded within the body region to occlude and seal off the access to the body cavity.
  • the plug may include a compressible porous material covered by a membrane or sheath (e.g., compliant layer) that may assist in creating the seal against the body tissue.
  • the occlude may include one or more balloons.
  • the plug may have a channel or lumen that permits operation of the other components of the apparatus through the plug, without disrupting the seal.
  • the plug may surround an external portion of the elongate member such that suction can be applied through a lumen of the elongate member.
  • a surgical drain apparatus comprising: a first elongate member having a lumen; a second elongate member that is slidably disposed in the lumen of the first elongate member; a distal porous drain having a proximal end coupled to a distal end region of the second elongate member, the distal porous drain comprising a network of interconnected pores; a vacuum channel extending proximally from the distal porous drain and in fluid communication with the network of interconnected pores; and a plug assembly positioned around an outer surface of the first elongate member, the plug assembly comprising an elastic body covered by a covering, wherein the covering is arranged to apply a radial compression force on the elastic body to radially compress the elastic body and to release the compression force to allow the elastic body to reassume a radially expanded state.
  • the covering may comprise a compression layer and a fluid barrier layer, the compression layer configured to apply the compression force.
  • the compression layer may comprise an expandable mesh.
  • the covering may be coupled to a slidable proximal connector configured to elongate the covering when driven distally, thereby creating the radial compression force.
  • the slidable proximal connector may be configured to apply an axial compression force on the elastic body when driven distally, thereby reinforcing the elastic body in the radially expanded state.
  • the plug assembly may comprise multiple elastic bodies that are configured to slide axially with respect to the first elongate member, wherein the slidable proximal connector is configured to compress the multiple elastic bodies together when driven distally.
  • the plug assembly may include an actuator configured to activate the slidable proximal connector.
  • the slidable proximal connector may be configured to be activate by hand.
  • the elastic body may have flat sides that are oriented at a predetermined angle with respect to the outer surface of the first elongate member when the elastic body is in the radially expanded state. The predetermined angle may be about 90 degrees.
  • the elastic body may be configured to fold radially inward upon when the radial compression force is applied on the elastic body.
  • the covering may be configured to twist with respect to the first elongate member.
  • the covering may be coupled to a slidable proximal connector that is configured to rotate with respect to the first elongate member when driven proximally, thereby twisting the covering.
  • the elastic body may be positioned at a distal end of the first elongate member, wherein the distal porous drain is configured to distally exit the first elongate member through the distal end of the first elongate member.
  • the elastic body may comprise a foam or a sponge.
  • the plug assembly may include one or more locks configured to lock the elastic body in the radially expanded state.
  • the one or more locks may further be 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 expanded state.
  • the elastic body may have an oblong radial cross section when in the radially expanded state.
  • the elastic body may have a rectangular axial cross section when in the radially expanded state.
  • the elastic body may have a round axial cross section when in the radially expanded state.
  • the elastic body may have an oblong axial cross section when in the radially expanded state.
  • Also described herein is a method of draining a body region, the method comprising: positioning a distal porous drain into the body region by advancing a second elongate member that is coupled to the distal porous drain distally within a lumen of a first elongate member, the distal porous drain comprising a network of interconnected pores; positioning a plug that is disposed around the first elongate member into a body channel that leads to the body region, the plug including an elastic body covered by a covering, wherein the plug is in a radially compressed state during positioning of the plug in which the covering places a radial compression force on the elastic body; creating a seal to maintain a vacuum within the body region by expanding the plug within the body channel, wherein expanding the plug comprises releasing the radial compression force placed on the elastic body by the covering; and applying negative pressure within the body region by applying suction in a proximal direction via the network of interconnected pores.
  • the covering may comprise a compression layer and a fluid barrier layer, the compression layer configured to apply the compression force.
  • the compression layer may comprise an expandable mesh.
  • the method may further comprise placing the plug in the radially compressed state by driving a slidable proximal connector in a proximal direction to elongate the covering, thereby creating the radial compression force on the elastic body.
  • the radial compression force may cause the elastic body to fold radially inward.
  • Creating the seal may comprise reinforcing the elastic body in a radially expanded state by driving the slidable proximal connector distally to apply an axial compression force on the elastic body.
  • the plug assembly may comprise multiple elastic bodies that are configured to slide axially with respect to the first elongate member, wherein creating the seal comprises driving the slidable proximal connector distally to compress the multiple elastic bodies together.
  • Driving the slidable proximal connector in the proximal direction may comprise activating an actuator.
  • Driving the slidable proximal connector in the proximal direction may comprise pulling a handle by hand.
  • the elastic body may have flat sides that are oriented at a predetermined angle with respect to the outer surface of the first elongate member when the elastic body is in a radially expanded state. The predetermined angle may be about 90 degrees. Releasing the radial compression force placed on the elastic body may comprise untwisting the covering is configured.
  • the elastic body may be positioned at a distal end of the first elongate member, wherein advancing the second elongate member causes the distal porous drain to exit the first elongate member through the distal end of the first elongate member.
  • the elastic body may comprise a foam or a sponge. Creating the seal comprises locking the plug in a radially expanded state. The method may further comprise locking the plug in a radially compressed state.
  • the apparatus may be configured to operate passively.
  • the distal porous drain and/or the plug may be configured to passively expand when placed within a body region and passively collapse when being removed from a body region (e.g., without activation).
  • the distal porous drain and/or the plug may be expanded and/or collapsed by activation of one or more actuators.
  • the actuator(s) may be on a region of the apparatus that is outside of the body cavity, such as one or more handles of the apparatus.
  • the actuator(s) may be actuated by sliding, pulling, pushing and/or applying pressure (e.g., by a user’s hand).
  • the distal porous drain typically has pores that may be sufficiently large to allow fluids and some solid biological debris (e.g., clots, pus, coagulate) to pass easily.
  • the pores may have a pore diameter that is 0.1 mm or greater (0.2 mm or greater, 0.3 mm or greater, 0.4 mm or greater, 0.5 mm or greater, 0.6 mm or greater, 0.7 mm or greater, 0.8 mm or greater, 0.9 mm or greater 1mm or greater, 1.1 mm or greater, 1.2 mm or greater, 1.3 mm or greater, 1.4 m or greater, etc.).
  • the pores may be formed by the spaces between the strands, e.g., in woven, braided and/or knitted porous meshes.
  • Any of the distal porous drain may be selfexpanding (e.g., formed of a material such as Nitinol, nitinol mixed with polymers, etc.).
  • any of these apparatuses may be coated with one or more materials to enhance their biological efficacy.
  • these apparatuses may be coated with a clot-promoting material, such as aprotinin, tranexamic acid (TXA), epsilon-aminocaproic acid and aminomethylbenzoic acid.
  • a clot-promoting material such as aprotinin, tranexamic acid (TXA), epsilon-aminocaproic acid and aminomethylbenzoic acid.
  • TXA tranexamic acid
  • epsilon-aminocaproic acid aminomethylbenzoic acid
  • any of the distal porous drains described herein may include a clot-promoting material.
  • any of the apparatuses may include one or more seals between the first elongate member and the second elongate member.
  • the seals may be configured (e.g., shaped, positioned, formed of an appropriate material, etc.) to allow the second elongate member to slide within the lumen of the first elongate member, without requiring much force to slide.
  • the seals may be O-rings (or multiple O-rings), which may be lubricated or unlubricated.
  • the apparatuses may be configured to hold the relative position of the first elongated member, and the second elongate member. This may be done 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 allow the relative positions to be held until additional force is applied to overcome the holding force.
  • the lock may be a ratcheting element at the proximal end of the apparatus (e.g., on or part of a handle at the proximal end).
  • the body region may be a uterus, and the method may be a method of contracting a uterus to reduce hemorrhaging.
  • the body region may be a wound, and the method may be a method of enhancing healing by draining the wound and/or reducing hemorrhaging and/or enhancing healing.
  • these methods and apparatuses may be used following a breast surgery, treating (e.g., draining) a chest wound, a hernia, etc.
  • the distal porous drain expands within a body region.
  • the distal porous drain may be soft compliant, for example, when expanded. Any of the methods may include conforming the distal porous drain within the body region being treated; this may include flattening the distal porous drain.
  • creating the seal may comprise expanding a plug that is positioned on a proximal region of the elongate member.
  • Applying negative pressure may comprise applying suction from a distal end of an elongate member.
  • applying negative pressure comprises applying suction from one or more openings through a sidewall of the distal end region of a second elongate member.
  • these methods may include distributing a force of the vacuum to compress the body region by applying negative pressure from the distal porous drain.
  • the distal porous drain may help distribute the force of the negative pressure.
  • the distal porous drain may be withdrawn, while leaving the apparatus, including (in some examples) the plug maintaining the negative pressure in place.
  • the negative pressure within the body region may be maintained for any appropriate length of time for treatment.
  • the negative pressure may be maintained for 1 minute or longer (e.g., 2 minutes or longer, 5 minutes or longer, 10 minutes or longer, 15 minutes or longer, 20 minutes or longer, 25 minutes or longer, 30 minutes or longer, 45 minutes or longer, 1 hour or longer 1.5 hours or longer, 2 hours or longer, 3 hours or longer, 4 hours or longer, 5 hours or longer, 6 hours or longer, 7 hours or longer, 8 hours or longer, etc.).
  • the distal end of the distal porous drains may be positioned within the tissue to be treated, such as, e.g., within the uterus.
  • surgical drain apparatus comprising: a first elongate shaft; a second elongate shaft having a suction lumen extending therethrough, wherein the second elongate shaft is configured to move axially within the first elongate shaft; a distal porous drain extending distally from a distal end region of the first elongate shaft and the second elongate shaft, wherein the distal porous drain comprises two or more layers of porous material surrounding a central lumen that is in fluid communication with the suction lumen; and a compressible and self-expanding plug assembly on an outer surface of the first elongate shaft.
  • the two or more layers of porous material may comprise a mesh.
  • 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 non-woven porous sheet of material.
  • the two or more layers of porous material may comprise an inverted mesh tube having a first end coupled at to the first elongate shaft and a second end coupled to the second elongate shaft.
  • the distal porous drain may be tubular and may have two or more concentric cylindrical mesh walls.
  • the central lumen may be opened at distal end region of the distal porous drain.
  • the distal porous drain may be a non-tubular structure.
  • the plug assembly may comprise an elastic body, an expandable mesh that is configured to radially compress the elastic body, and a fluid barrier membrane.
  • the elastic body may be a foam material.
  • the compressible and self-expanding plug assembly may comprise a viscoelastic foam.
  • the elastic body may be compressed and may selfexpand back to its uncompressed configuration.
  • Any of these apparatuses may include one or more locks configured to lock the plug assembly in a radially expanded configuration, a radially compressed configuration, or the radially expanded configuration and the radially compressed configuration.
  • the distal porous drain may be configured to be compressed along a distal to proximal length.
  • Any of these apparatuses may include apparatus a suction port at a proximal end region of the apparatus.
  • Any of these apparatuses may include a suction connector having a suction port on a proximal end and a releasable connector on a distal end, wherein the releasable connector is configured to couple to the first elongate shaft.
  • the distal porous drain may have a diameter in a relaxed state of greater than 2 cm.
  • the distal porous drain may be configured to extend out of the first elongate shaft or retract into the first elongate shaft as the second elongate shaft is moved axially relative to the first elongate shaft.
  • Any of these apparatuses may include a stop (e.g., rim, ridge, catch, detent, etc.) limiting axial movement of the second elongate shaft relative to the first elongate shaft to prevent the second elongate shaft from extending distally out of the first elongate shaft.
  • a surgical drain apparatus may include: a first elongate shaft; a second elongate shaft having a suction lumen extending therethrough, wherein the second elongate shaft is configured to move coaxially relative first elongate shaft; a distal porous drain comprising an inverting tube having a first end coupled to a distal end region of the first elongate shaft and a second end coupled to a distal end region of the second elongate shaft so that the distal porous drain comprises two or more adjacent layers of mesh surrounding a central lumen that is in fluid communication with the suction lumen; and a compressible and self-expanding plug assembly on an outer surface of the first elongate shaft.
  • a surgical drain apparatus includes: a first elongate shaft; a second elongate shaft having a suction lumen extending therethrough; a distal porous drain extending distally from a distal end region of the first elongate shaft and the second elongate shaft, wherein the distal porous drain comprises a mesh tube inverted over itself to form adjacent cylindrical layers surrounding a central lumen that is in fluid communication with the suction lumen; and a compressible and self-expanding plug assembly on an outer surface of the first elongate shaft.
  • a method may include: positioning a distal porous drain into the body region, wherein the distal porous drain extends distally from a first elongate shaft and a second elongate shaft coaxial with the first elongate shaft, further wherein the distal porous drain comprises two or more concentric layers of flexible porous material surrounding a central lumen that is in fluid communication with a suction lumen extending through the first 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 so that a plurality of flow paths are created through and between the two or more concentric layers of porous material along a length of the distal porous drain.
  • the two or more concentric layers of porous material may include a mesh material.
  • the distal porous drain may be attached at a first end to the first elongate shaft and at a second end to the second elongate shaft.
  • Any of these methods may include maintaining suction as the distal porous drain is compressed by the body region.
  • positioning the distal porous drain in the body region may comprise advancing the second elongate shaft distally to extend the distal porous drain distally out of the first elongate shaft and distally of the second elongate shaft into the body region.
  • Any of these methods may include maintaining the negative pressure within the body region after withdrawing the distal porous drain from the body region.
  • Creating the seal may include expanding a plug assembly coupled to the first elongate shaft into a body channel that leads to the body region.
  • the plug assembly may be disposed around an outer surface of the first elongate shaft.
  • Any of these methods may include locking the plug assembly in a radially expanded configuration to maintain the seal.
  • Any of these methods may include radially compressing the plug assembly before positioning the plug assembly within the body channel.
  • Radially compressing the plug assembly may comprise proximally pulling a compression layer covering an elastic body such that the compression layer elongates and applies a radial compression force on the elastic body.
  • Any of these methods may include connecting the suction lumen to a source of suction prior to applying the negative pressure.
  • Coupling the suction lumen may comprise releasably coupling the first elongate shaft to a suction connector having a friction fit connector for the first elongate shaft and a suction port configured to couple to a source of negative pressure.
  • FIGS. 1A-1B schematically illustrate one example of a surgical drain apparatus as described herein including a two-layer distal porous drain.
  • FIG. IB shows a sectional view though the example of FIG. 1A.
  • FIGS. 1C-1F illustrate the example apparatus of FIGS. 1A-1B treating a tissue region.
  • FIG. 1C illustrates a section top view of a body region; and
  • FIG. ID illustrates the same body region from a section side view.
  • FIG. IE shows the apparatus of FIGS. 1A-1B inserted into the body region of FIGS. 1C and ID from the same view through the body region as FIG. 1C.
  • FIG. IF shows the apparatus of FIGS. 1A-1B shown in FIG. IE from the same view through the body region as FIG. ID, showing compression of the flexible distal porous drain without vacuum lock.
  • FIGS. 2A-2E illustrate side views of example apparatuses having different tubular distal porous drains.
  • FIGS. 3A1-3E2 illustrate distal end views and side views of example apparatuses having tubular distal porous drains.
  • FIGS. 4A1-4E2 illustrate distal end views and side views of example apparatuses having different distal porous drains.
  • FIGS. 5A1-5A4 illustrate an example of how an apparatus with a tubular distal porous drain may provide fluid paths for drawing fluid and/or gas.
  • FIGS. 6A-6C illustrate partially transparent side views an example apparatus that includes an invertible tubular distal porous drain.
  • FIGS. 10A-10B illustrate an example plug assembly where an outer surface of an elastic body is covered with a covering.
  • FIGS. 14A-14D illustrate an example plug assembly where an elastic body is positioned axially at a distal end of an elongate member.
  • FIG. 15 illustrates example elastic bodies having different axial cross section and radial cross section shapes.
  • FIGS. 16A-16B illustrate an example of an invertible tubular distal porous drain that is configured to take on a bent shape when extended from an elongate member.
  • FIGS. 17A-17F illustrate an example apparatus that includes an invertible distal porous drain and a plug.
  • FIGS. 18A-18B illustrate an example apparatus having an invertible distal porous drain and that is biased to take on a bent shape when expanded.
  • FIG. 19 is a flowchart for an example method of treating a body region using an apparatus described herein.
  • FIGS. 20A-20B illustrate an example of sealing connector (e.g., sealing cap)for coupling any of the apparatuses described herein to a source of suction.
  • FIG. 20A shows the sealing cap before attachment and
  • FIG. 20B shows the sealing cap after attachment.
  • FIGS. 21A-21B illustrate an example of a sealing connector (sealing cap) configured as a male sealing connector, for coupling any of the apparatuses described herein to a source of suction.
  • FIG. 21 A shows the sealing cap before attachment and
  • FIG. 2 IB shows the sealing cap after attachment.
  • FIGS. 22A-22B illustrate an example of a sealing connector (sealing cap) configured as a female sealing connector, for coupling any of the apparatuses described herein to a source of suction.
  • FIG. 22A shows the sealing cap before attachment and FIG. 22B shows the sealing cap after attachment.
  • FIGS. 23A-23B illustrate an example of a sealing connector (sealing cap) configured as a female sealing connector, for coupling any of the apparatuses described herein to a source of suction.
  • FIG. 23A shows the sealing cap before attachment and
  • FIG. 23B shows the sealing cap after attachment.
  • FIGS. 24A-24F illustrate one example of a sealing connector (sealing cap) similar to that shown in FIGS. 22A-22B and 23A-23B coupled to a surgical drain apparatus as described herein.
  • FIG. 24A shows a perspective view of the sealing cap;
  • FIG. 24B shows a side view of the sealing cap and proximal end of the drain apparatus.
  • FIG. 24C shows an end view of the sealing cap and proximal end of the drain apparatus.
  • FIG. 24D shows another perspective view of the sealing cap and proximal end of the drain apparatus.
  • FIG. 24E shows a transparent view and
  • FIGS. 24F shows a sectional view of the sealing cap and proximal end of the drain apparatus.
  • FIGS. 25A-25E illustrate an example of a sealing connector (sealing cap) similar to that shown in FIGS. 20A-20B and 21A-21B coupled to a surgical drain apparatus as described herein.
  • FIG. 25A shows a side view of the sealing cap and proximal end of the drain apparatus.
  • FIG. 25B show an end view.
  • FIG. 25C shows a partially transparent perspective view.
  • FIG. 25D shows a transparent view of the sealing cap and proximal end of the drain apparatus.
  • FIG. 25E shows a sectional view through the sealing cap and proximal end of the drain apparatus.
  • FIGS. 26A-26H show different examples of compressible/expandable plugs (e.g., foam plugs) or partial plugs that may be included as part of any of the apparatuses described herein.
  • the plugs shown in FIGS. 25A-26H may be part of a larger plug structure.
  • FIGS. 27A-27G illustrate examples of surgical drain apparatuses including compressible/expandable plug structures using multiple partial plugs such as those shown in FIGS. 26A-26H.
  • FIG. 28 schematically illustrates an example of a surgical drain apparatus including a plug structure formed of multiple different form plug components having different stiffness.
  • FIGS. 29A-29B schematically illustrate examples of surgical drain apparatuses having different compressible/expandable plugs attached by adhesive to the rest of the apparatus.
  • FIGS. 3OA-3OB schematically illustrate examples of surgical drain apparatuses having compressible/expandable plugs attached by different variations of adhesive to the rest of the apparatus.
  • FIGS. 31A-31D show schematics of end views of apparatuses having compressible/expandable plugs attached by different variations of adhesive to the rest of the apparatus.
  • FIGS. 32A-32C schematically illustrate examples of surgical drain apparatuses having different plug configurations and fixed, inverted tube drains.
  • FIGS. 33A-33B schematically illustrate examples of surgical drain apparatuses having different plug configurations and fixed, inverted tube drains.
  • FIGS. 34A-34B schematically illustrate examples of surgical drain apparatuses having different plug configurations and fixed, inverted tube drains.
  • FIG. 35 shows another example of a surgical drain apparatus having a fixed and inverted (e.g., 2 layer) drain tube at the distal end with a multi-layered plug.
  • FIGS. 36A-36B schematically illustrate examples of surgical drain apparatuses having compressible/expandable plugs that are attached to the shaft of the apparatus by an adhesive, similar to the examples shown in FIGS. 29A-29B, but with a fixed and inverted (e.g., 2 layer) drain tube at the distal end of the apparatus.
  • a fixed and inverted (e.g., 2 layer) drain tube at the distal end of the apparatus.
  • FIGS. 37A-37B schematically illustrate examples of surgical drain apparatuses having compressible/expandable plugs that are attached to the shaft of the apparatus by an adhesive, similar to the examples shown in FIGS. 3OA-3OB, but with a fixed and inverted (e.g., 2 layer) drain tube at the distal end of the apparatus.
  • a fixed and inverted (e.g., 2 layer) drain tube at the distal end of the apparatus.
  • FIGS. 38A-38C illustrate the operation of another example of a surgical drain having a passive seal with a non-rolling, expandable 2-layer porous drain that is coupled to a retractable sheath.
  • FIGS. 39A-39B illustrates the operation of another example of a surgical drain apparatus including an expandable/compressible plug assembly including a cover.
  • FIGS. 40A-40B illustrate the operation of an example of a surgical drain apparatus including an expandable/compressible plug assembly including a plurality of straps.
  • FIGS. 41A-41C schematically illustrate examples of surgical drain apparatuses having deconstructing plug assemblies that may be removed by pulling a tether to at least partially deconstruct the plug.
  • FIGS. 42A-42B illustrate the operation of another example of a surgical drain apparatus including a tether to transform the apparatus from an expanded plug configuration to a collapsed plug configuration.
  • Described herein are methods and apparatuses (systems and devices) for draining a region of a body to remove fluid or material from the region and/or contracting the region. This treatment may prevent or reduce bleeding and/or may otherwise enhance healing.
  • These apparatuses and methods, including methods of using them may be particularly useful for forming regions of uniform negative pressure within a cavity surrounded by soft tissue, and sustaining the negative pressure while atraumatically removing the apparatus from the cavity.
  • the apparatuses may be designed to be simple to use.
  • apparatuses including surgical drain systems, which may include an elongate tubular body, which may be flexible, forming an outer shaft and a distal porous drain structure extending from a 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.) may be drained by the application of negative pressure.
  • fluid e.g., blood, lymph, etc.
  • the distal porous drain may include a multi-layered tube of flexible material having a plurality of openings (e.g., pores) all along its length.
  • the multiple layers of the tube may be formed by inverting a tubular porous material over itself so that it doubles back over itself.
  • the distal porous drain may be formed of a tube of mesh (e.g., knitted, worn, and/or braided mesh) that is inverted back over itself and the ends of the inverted tube are attached more proximally.
  • the distal end, formed by the inverted region that doubles back over itself, may be open or may be closed, and may generally form a relatively soft, atraumatic distal end.
  • the distal porous drain therefore forms a central lumen having two tubular layers of porous material, with a central lumen. Suction may be applied though the central lumen.
  • the two (or in some cases, more) cylindrical layers forming the tubular porous drain may allow fluid to be drawn in though the pores and may distributes the suction across the porous drain, preventing suction locking even when the tissue compresses against all or a portion of the distal porous drain.
  • the length of the distal porous drain may be static and the ends of the inverted porous material (e.g., mesh) fixed relative to each other.
  • the distal porous drain may be extended or retracted in length, e.g., by attaching a first end of an inverting distal porous drain to a first shaft (e.g., an outer shaft) and a second end of the distal porous drain to a second shaft (e.g., an inner shaft) that is concentric with the first shaft.
  • the first end may be inverted relative to the second end. Moving the first shaft relative to the second shaft may therefore cause the distal porous drain to extend or retract distally /proximally.
  • Embodiments in which the distal porous drain may be extended or retracted by rolling and inverting over itself may be referred to herein as rolling drains.
  • Embodiments in which the distal porous drain is inverted over itself, but the ends are fixed relative to each other (e.g., both attached to a shaft such as an outer shaft) may be referred to as a non-rolling drain or equivalently as a static drain.
  • An apparatus including a non-rolling drain may be manually inserted into the body region to be treated (e.g., uterus).
  • An apparatus including a rolling drain may be inserted partially into the uterus (or to the opening into the uterus) and one or both shafts may be moved relative to each other to extend the flexible distal porous drain distally into the body region being treated (e.g., uterus).
  • a device having a rolling drain may be manually inserted in the same manner as a non-rolling drain, but may be removed by moving one of the concentrically- arranged shafts to withdraw the distal porous drain from the body.
  • a non-rolling drain may be withdrawn by pulling it proximally out of the body.
  • Both non-rolling and rolling drains may be operated in the same manner, and may distribute a negative pressure (e.g., suction) applied by the apparatus within the body region being treated.
  • a negative pressure e.g., suction
  • the negative pressure may be applied through pores of the porous structure to cause fluid to flow within the pores and out of the body region. This may help to remove inflammatory mediators, bacteria, foreign material, and/or necrotic tissue, thereby promoting healing of soft tissue.
  • the negative pressure may cause the soft tissue walls surrounding the body cavity to at least partially contract, which may reduce hemorrhaging.
  • the distal porous drain may be formed of two or more concentrically arranged layers having pores (e.g. openings) to allow fluid to pass through.
  • the pores may be non-overlapping or partially overlapping between adjacent layers.
  • the distal porous drain may be formed of concentrically arranged cylindrical layers.
  • the porous layers may be formed as a mesh material.
  • the distal porous drain may be flexible.
  • the distal porous drain may be laterally compressible, and may be compressed between the tissue walls or layers; because of the multiple porous layers, the distal porous drain may not form a vacuum lock within the tissue.
  • the porous structure is configured to distribute the negative pressure more effectively than existing surgical drains.
  • the porous structure may have numerous interconnected pores distributed throughout the porous structure, which act as a network of channels for drawing fluid and/or air from the body cavity (e.g., uterus).
  • the porous structure e.g., fabric, mesh, etc.,
  • the layers may be formed as a tube that is inverted back over itself. This may form a network of channels that provides a more uniform negative pressure over a large surface area, thereby providing efficient removal of fluid and/or air and reduces the change of clogging.
  • the porous structure is typically compliant and may at least partially conform to the region of the tissue into which it is positioned.
  • the porous structure may a mesh, which may be made of a woven, knitted, braided, and/or non-woven material. In some examples this porous structure is a fabric.
  • the distal porous drain may be formed of a tube of porous material (e.g., mesh, fabric, such as a knitted, woven or braided material) that is inverted over itself, typically at the distal end, to form a two or more (e.g., multi) layered tube.
  • the distal end opening of the multilayered tube may be opened or closed.
  • the distal porous drain may be configured as a rolling drain that inverts and rolls over itself to deploy and/or retract.
  • the distal porous drain may be static, so that it does not roll over itself, but is inserted into the body already deployed. In both rolling and non-rolling (static) drain examples, the distal porous drain may be compressed to conform to the width and/or height of the region of the body into which it is inserted (e.g., the uterus).
  • the distal porous drain may be coupled to one or more elongate members (e.g., tube, catheter and/or rod). At least one of the elongate members may include a lumen configured for supplying a negative pressure (e.g., vacuum) to the distal porous drain. This suction lumen may be coupled to a distal region of the elongate member and therefore the distal porous drain.
  • the apparatus may include one or more additional elongate members, which may help to deliver the distal porous drain within a body region and/or retract the distal porous drain from the body region. In some examples, the apparatus is configured to invert the distal porous drain during delivery and/or withdrawal of the distal porous drain from the body cavity.
  • any of these apparatuses may include a sealing connector, e.g., sealing cap or other sealing structure at a proximal end of the apparatus that is configured to releasably the proximal end of the elongate member (e.g., catheter, tube, etc.) to a source of negative pressure.
  • the sealing connector may include a negative pressure coupler for coupling to a tube or other source of negative pressure and distal sealing region for coupling to the distal end region of the elongate member.
  • the sealing connector may be removable from the elongate body and may be coupled and sealed to either or both the outside and inside of the elongate body. Alternatively, in some examples, the sealing cap may be integrated into the elongate body.
  • any of these apparatuses may also include a plug assembly (“plug”) or closure, typically on the elongate shaft, proximal to the distal porous drain, that may allow the treated region to retain the negative pressure within the body region.
  • the apparatus may include one or more plugs or plug regions that are configured to contact and may be configured to expand against (e.g., may be compressible and expandable), and provide a seal with, surrounding soft tissue, for example, in a canal or channel that leads to a body cavity being treated.
  • the plug assembly may be a radially expandable and collapsible feature that is arranged along the elongate member proximally relative to the porous structure.
  • the plug assembly may provide a plugging force (e.g., sealing force) against the tissue of the channel.
  • a plugging force e.g., sealing force
  • the porous structure and the plugs may be collapsed and/or retracted for gentle removal from the body region.
  • the plug or plug region(s) may be deconstructed to collapse.
  • the plug or plug region may include a foam material (e.g., a viscoelastic polyurethane foam, or low- resistance polyurethane foam) that may be compressed and may self-expand to fill and plug the body channel, canal, etc. to maintain the vacuum distal to the plug.
  • the plug assembly may be disassembled and removed.
  • the surgical drain apparatuses described herein may include a delivery configuration having a relatively small OD that prevents or reduces trauma when the apparatus is inserted into the tissue.
  • the distal porous drain and/or plug assembly may be configured to compress to a sufficiently small OD for atraumatic entry into a body canal, channel or cavity.
  • the distal porous drain and/or plug assembly may be configured for expansion out of and/or retraction into an elongate member of the apparatus during deployment and/or withdrawal of the apparatus from the body region.
  • the distal porous drain and plug assembly may be configured to naturally (e.g., automatically) compress when placed within the confines of a body canal or channel and naturally (e.g., automatically) expand to apply a sealing force when placed within a larger body cavity or when withdrawn outside of the body.
  • the distal porous drain structure may be pushed, or otherwise advanced and/or positioned, into the region of the body to be drained, so that once positioned it may remove fluid from the body region.
  • Any tissue of the body may be treated with the surgical drains described herein.
  • soft tissue regions such as a pocket, chamber, opening, etc. formed or naturally present in tissue.
  • the soft tissue to be treated may be a surgically formed or traumatically formed region of the body, such as a tunneling wound, dead space, seroma forming pocket (surgical wound), etc.
  • the soft tissue to be treated may be a cavity formed by removal of a tumor or other tissue.
  • the soft tissue to be treated may be a natural orifice space (bladder, intestine, stomach, uterus, chest cavity, lungs, blood vessel, etc.) or the like.
  • the soft tissue to be treated may be a uterus.
  • FIGS. 1A-1F show an example of a surgical drain apparatus 100 and an example use of the apparatus in a soft tissue region of a body.
  • FIG. 1A shows a side view of the apparatus 100, which includes an elongate member 102 (also referred to herein as an elongate shaft) and a distal porous drain 106 coupled to a distal region of the elongate member 102.
  • the elongate member 102 is a flexible tube (e.g., a polymeric tube) that includes a lumen 104.
  • the lumen of the second elongate member 102 is in fluid communication with the distal porous drain 106.
  • the distal porous drain in this example is formed by a
  • a distal end region of the elongate member 102 may include one or more openings that provide fluidic access to the porous network of the distal porous drain 106.
  • the elongate member 102 (e.g., elongate shaft) may be any appropriate length so that it may be manipulated and position the distal porous drain 106 within the body region being treated.
  • the elongate member 102 may be between 5 cm and 100 cm long (e.g., between 10 cm and 50 cm, between 10 cm and 35 cm, etc.).
  • the elongate member 102 may be straight (as shown) or curved, including curved with a fixed curve (e.g., between 10-80 degrees). In some cases, the elongate member 102 may be laterally flexible.
  • the elongate member 102 extends distally at least partially within the distal porous drain 106. In other cases, the elongate member 102 does not extend distally within the distal porous drain 106.
  • the distal porous drain 106 is configured as a rolling drain, and a second elongate member (elongate shaft, not shown) may be concentrically arranged within the first elongate member 102, and may be coupled to one end of the material (e.g., mesh) forming the distal porous drain.
  • the distal porous drain 106 may be radially compressible such that the outer diameter of the distal porous drain 106 is sufficiently reduced for entry into a soft tissue region.
  • the distal porous drain 106 may be flexible and laterally deflectable (i.e., bendable) to conform to the anatomy of the body tissue.
  • the distal porous drain 106 may include a plurality and/or network of pores (e.g., mesh, open cell structure) that is configured to draw fluid and/or air from a body cavity.
  • the distal end of the distal porous drain 106 is shown as an open cylinder of mesh material that is inverted back over itself at the distal end of the porous drain region, which may form an atraumatic distal end region; both ends of the mesh material forming the distal porous drain may be attached to the distal end region of the elongate shaft 102.
  • FIG. 1C shows a first cross sectional view of a soft tissue region of a body that includes a cavity 120 and a channel 122 that leads to the cavity 120.
  • the soft tissue region may be a surgical site, such as a postpartum uterus or a site of removal for tumor.
  • the channel 122 may include a portion of a vaginal canal and the cavity may include a postpartum uterus.
  • FIG. ID shows a second sectional view (taken at 90 degrees offset from the view shown in FIG. 1C). As shown, tissue may be open more in one direction than another.
  • FIG. IE shows the apparatus 100 after being inserted within the body region and as a negative pressure (suction) is applied.
  • the distal porous drain 106 is positioned within the cavity 120 and the second elongate member 102 is positioned within the channel 122.
  • the distal porous drain 106 and the elongate member 102 are advanced through a lumen of an elongate introducer member 103.
  • the elongate introducer member 103 may be advanced within the channel 122, then the distal porous drain 106 may be distally extended out of the elongate introducer member 103 and into the cavity 120 by pushing the elongate member 102 relative to the elongate introducer member 103.
  • the elongate introducer member 103 may form a seal with the walls of the soft tissue walls of the channel 122 so that sufficient negative pressure can form within the cavity 120.
  • the introducer member is optional.
  • an elongate introducer member 103 is included and has one or more sealing features (e.g., plugs) to facilitate the sealing, as described herein.
  • the apparatus 100 includes a plug assembly extending from the outer surface of the elongate member 102.
  • the distal porous drain 106 may be compressed into a compressed state prior to advancing through the channel 122. Once within the cavity 120, the distal porous drain 106 may expand into an expanded state. In some cases, the distal porous drain 106 may at least partially change shape (e.g., bend) when inserted within the cavity 120, for example, by pressure from contact with surrounding tissue. In some cases, the distal porous drain 106 may be configured to take on a pre-determined shape (e.g., bent shape), for example, to conform to a shape of a particular body cavity.
  • a pre-determined shape e.g., bent shape
  • the elongate member 103 and/or the elongate introducer member 102 may include one or more stops that limit their relative axial movement.
  • the elongate member 103 and the elongate introducer member 102 may be configured to lock with respect to each other when the distal porous drain 106 extends distally and/or retracts proximally by a predetermined amount.
  • the apparatus includes one or more locks configured to releasably lock the relative axial positions of the elongate member 103 and the elongate introducer member 102.
  • a negative pressure may be applied through the lumen 104 of the elongate member 102 to cause fluid and/or gas from the cavity 120 to flow proximally through the distal porous drain 106, into the elongate member 102, and eventually out of the body tissue.
  • the elongate member 102 may include one or more openings at a distal end of the elongate member (and/or within a side wall in a distal region of the elongate member 102).
  • the suction lumen through the elongate member 102 may be in fluid communication with the lumen of the distal porous drain 111.
  • the distal porous drain 106 can maintain a shape that provides efficient flow of fluid and/or gas through the network of pores of the distal porous drain 106, even when compressed by the tissue, as shown in FIG. IF.
  • the negative pressured applied by the distal porous drain 106 may apply in inward force on the surrounding walls of the cavity 120 (indicated by inward facing arrows in FIG. IE), thereby causing the cavity 120 (e.g., uterus) to at least partially contract.
  • Such contraction may be beneficial, for example, in cases where contracting a postpartum uterus may reduce hemorrhaging.
  • distal porous drain 106 has tubular shape
  • application of the negative pressure may flatten the outer shape of the tube, creating a flattened tube shape.
  • the pores of the distal porous drain may sufficiently maintain their shape to allow fluid, material and/or air to pass therethrough.
  • the distal porous drain structure 106 may be removed from the cavity 120 by proximally moving the distal porous drain 106 out of the cavity 120.
  • the distal porous drain 106 may be retracted within the elongate introducer member 103.
  • retraction into the elongate introducer member 103 may cause the distal porous drain 106 to radially contract.
  • the elongate member 102 may be pulled to directly pull the distal porous drain 106 out of the cavity 120.
  • the plug assembly may optionally be collapsed before or as the apparatus is removed.
  • the negative pressure may be maintained for a period of time to provide a therapeutic benefit.
  • the negative pressure may be applied until the cavity 120 is sufficiently drained of fluid and/or the cavity 120 is sufficiently contracted.
  • the period of time may range from one minute to several hours or even days.
  • the period of time may range from one minute to 5 days or more (e.g., 10 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, or 10 hours, 12 hours, 18 hours, 24 hours, 48 hours, 3 days, 4 days, 5 days, etc.).
  • the negative pressure is optionally maintained within the cavity 120 for a period of time after withdrawing the distal porous drain 106 from the cavity 120.
  • maintaining the negative pressure after removal of the distal porous drain 106 may help to contract a uterus and mitigate uterine hemorrhaging.
  • the negative pressure may be applied period of time may range from one minute to 10 hours (e.g., 10 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, or 10 hours) after withdrawal of the distal porous drain 106 from the cavity 120.
  • the negative pressure be applied via the elongate member 102 (e.g., in versions using a rolling drain) and/or the elongate introducer member 103 after withdrawing the distal porous drain 106.
  • the distal porous drain 106 and the elongate member 102 may be fully withdrawn proximally out of the elongate introducer member 103, and the negative pressure may be applied via the elongate introducer member 103.
  • the distal porous drain 106, elongate member 102 and the elongate introducer member 103 may be removed proximally from the cavity 120 and the channel 122.
  • any of the distal porous drain structures described herein may have an open pore structure in which pores/holes/spaces within the distal porous drain are interconnected to provide multiple channels throughout the distal porous drain.
  • the distal porous drain includes a porous material (e.g., mesh, fabric and/or textile), which may include woven, knitted or braided elements (e.g., filaments).
  • the distal porous drains may be formed of a knit, a weave, a braid, a non-woven sheet (e.g., polymer or metallic or mixes), or more preferably a flexible tube, of material having pores.
  • the braid may include any number of filaments, e.g., between 24-144 ends/filaments (e.g., between about 24-128 filaments, between about 32-98 filaments, etc.).
  • the filaments are formed of a material such as PET, Nylon, PP, Nitinol, Steel, Elgiloy, or some combination of these.
  • the filament may be any appropriate diameters, such as between 0.003” to 0.025” diameter filaments (e.g., monofilaments or compound filaments).
  • the distal porous drain is formed of filaments (knit, woven, braided, etc.) of between 100-2000 denier (e.g. multifilament or monofilament).
  • the mesh may have a mono or multi filament structure (or a mixture thereof).
  • the distal porous drain structure (“distal porous drain”) is made of a non-woven material, such as a punched material, slitted material, felt, melt blown material and/or foam material.
  • the distal porous drain structure may be formed by extrusion, punching, stamping, blowing, laser cutting and/or other manufacturing techniques.
  • the distal porous drain structure may include an open cell structure (e.g., open cell or reticulated foam) that includes interconnected holes/spaces (e.g., cells).
  • the foam is similar to some types wound dressing foams used with negative pressure.
  • the foam may be reinforced with open textile structure (e.g., net-like tubes, sheets) to hold the foam together when placed under tension.
  • the foam may be a composite foam, or a fabric covered foam.
  • the distal porous drain includes a pore pattern, for example, with 1 mm to 4 mm holes (e.g., like as perforated structures with many holes per unit area).
  • the distal porous drain includes a pattern of slits, for example, with slits with 1 mm width to 3 mm width by 1 mm length to 15 mm length.
  • the distal porous drain structures described herein may be made of any of a number of biocompatible materials.
  • the distal porous drain includes one or more polymers, such as polyethylene terephthalate (PET), polytetrafluoroethylene (PTFE), silicone and/or polyurethane.
  • PET polyethylene terephthalate
  • PTFE polytetrafluoroethylene
  • silicone silicone
  • polyurethane e.g., polyurethane.
  • the PTFE is an expanded polytetrafluoroethylene (ePTFE).
  • the polymer includes a thermoplastic or thermoset material (e.g., thermoplastic or thermoset foam).
  • the distal porous drain includes one or more metals (e.g., metal filaments), such as nickel titanium alloy (e.g., nitinol), steel, Elgiloy and/or nickel-cobalt- chromium-molybdenum alloy (e.g., MP35N).
  • metals e.g., metal filaments
  • nickel titanium alloy e.g., nitinol
  • steel Elgiloy and/or nickel-cobalt- chromium-molybdenum alloy (e.g., MP35N).
  • MP35N nickel-cobalt- chromium-molybdenum alloy
  • the term “mesh” is not limited to structures formed by one or more strands, but may be formed of a non-woven material.
  • the material forming the mesh may be a porous filtering material such as Tyvek, filter paper, etc. or it may be (initially) non-porous and pores may be formed therein.
  • the term “mesh” may refer to a material having an average porosity of greater than 50% that may be formed into an inverting structure that is sufficiently compliant so that it may invert back over itself.
  • the mesh may be formed as a tubular or basket shape (e.g., open at both ends or closed at one end (e.g., the distal end). In some cases, the mesh may be shaped into a generally tubular shape (open at one or both ends). In some cases, the mesh may be shaped into a non-tubular shape.
  • the distal porous drain structures described herein may have any of a number of shapes.
  • the distal porous drain structure may have a tubular shape with an inner space (e.g., lumen).
  • the distal porous drain may include multiple tubes of porous material (e.g., concentrically arranged).
  • the distal porous drain may have a non-tubular structure, for example, where the porous material is throughout the thickness of the distal porous drain (i.e., does not include an inner lumen).
  • one or more of the elongate members may be flexible, semi-ridged or rigid.
  • the elongate member(s) may be formed of polyurethane or silicone. These apparatuses may be configured to have reasonably high column force while retaining bending flexibility.
  • the proximal direction may be the direction towards the hand of the user (e.g., physician, surgeon, medical technician, nurse, etc.) operating the device, and distal may be the direction away from the hand of the user.
  • FIGS. 2A-2E show side views of example apparatuses having different tubular distal porous drain structures when in extended and/or expanded states.
  • Each of the tubular distal porous drain structures shown in FIGS. 2A-2E has a porous wall (e.g., mesh wall) that is shaped in a tube such that porous wall defines an inner lumen.
  • the porous wall has many pores that are configured to allow fluid, materials and/or gas to pass therethrough when a negative pressure is applied.
  • Each of the tubular distal porous drains is coupled to a distal end region of a corresponding elongate member.
  • a suction can be applied in a proximal direction (e.g., via the elongate member coupled thereto, or another elongate member) to provide a negative pressure on the tubular distal porous drain.
  • a proximal direction e.g., via the elongate member coupled thereto, or another elongate member
  • Each of these examples may include multiple adjacent layers of porous material. The multiple layers may be formed by inverting a tube of the porous material back over itself or it may be formed by concentrically placing one or more tubes, bags or sheets of porous material into another tube or bag of porous material. Suction may be applied within the innermost channel (e.g., innermost tube or bag of porous material, e.g., mesh), so that suction passes through the multiple layers.
  • FIG. 2A shows an apparatus having a tubular distal porous drain 206 coupled to a distal region of an elongate member 202, where the tubular distal porous drain 206 has an outer diameter that is about the same diameter of the elongate member 202 when the tubular distal porous drain 206 is in an expanded state.
  • FIG. 2B shows an apparatus having a tubular distal porous drain 216 coupled to a distal region of an elongate member 212, where the tubular distal porous drain 216 has an outer diameter that is larger than a diameter of the elongate member 212 when the tubular distal porous drain 216 is in an expanded state.
  • FIG. 2A shows an apparatus having a tubular distal porous drain 206 coupled to a distal region of an elongate member 202, where the tubular distal porous drain 206 has an outer diameter that is about the same diameter of the elongate member 202 when the tubular distal porous drain 206 is in an expanded state.
  • FIG. 2C shows an apparatus having a tubular distal porous drain 226 coupled to a distal region of an elongate member 222, where the tubular distal porous drain 226 has an outer diameter that is smaller than a diameter of the elongate member 222 when the tubular distal porous drain 226 is in an expanded state.
  • FIG. 2D shows an apparatus having a tubular distal porous drain 236 coupled to a distal region of an elongate member 232, where the tubular distal porous drain 236 has an outer diameter that has a tapered shape when the tubular distal porous drain 226 is in an expanded state.
  • FIG. 2C shows an apparatus having a tubular distal porous drain 226 coupled to a distal region of an elongate member 222, where the tubular distal porous drain 226 has an outer diameter that is smaller than a diameter of the elongate member 222 when the tubular distal porous drain 226 is in an expanded state.
  • FIG. 2D shows
  • the tubular distal porous drain 226 tapers from a larger outer diameter at a proximal end of the tubular distal porous drain 226 to a smaller outer diameter at a distal end of the tubular distal porous drain 226.
  • a tubular distal porous drain may taper from a larger outer diameter at a distal end to a smaller outer diameter at a proximal end.
  • FIG. 2E shows an apparatus having two tubular distal porous drains 246a and 246b (shown in an expanded state) coupled to a distal region of an elongate member 242. In the example shown in FIG.
  • tubular distal porous drains 246a and 246b are in a non-parallel arrangement with respect to each other.
  • the tubular distal porous drains may be arranged in parallel.
  • An internal (second, third, fourth, etc.) layer of porous material may be within each of the distal porous drains shown in FIGS. 2A-2E.
  • tubular distal porous drains described herein may have any of a number of shapes and sizes and are not limited to those shown in FIGS. 2A-2E.
  • the apparatus described herein may include have any number of tubular distal porous drains (e.g., 1, 2, 3, 4, 5, 6 or more).
  • FIGS. 3A1-3E2 show distal end views and side views of additional example apparatuses having tubular distal porous drain structures.
  • FIG. 3 Al shows a distal end view and 3A2 shows a side view of an apparatus where, like the apparatus of FIG.
  • a tubular distal porous drain 306 has an outer diameter that is about the same diameter of an elongate member 302 when the tubular distal porous drain 306 is in an extended/expanded state.
  • the tubular distal porous drain 306 has an outer porous wall 308 (e.g., mesh wall) and an inner porous wall 311 that defines an inner space 309 (e.g., lumen).
  • the inner wall may be formed by inverting the mesh back into the outer wall (cylinder).
  • FIG. 3B 1 shows a distal end view and 3B2 shows a side view of an apparatus having an elongate member 312 and a tubular distal porous drain structure 316 that defines an inner space 319 similar to the tubular distal porous drain 306, except that a sheath 317 covers an outer surface of the tubular distal porous drain 316.
  • the sheath 317 may control the amount of fluid and/or gas flowing through the tubular distal porous drain 316 when negative pressure is applied. For example, as shown in the distal end view of FIG. 3B 1, the sheath 317 does not cover the distal end of the tubular distal porous drain 306.
  • 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.
  • FIG. 3D1 shows an end view and 3D2 shows a side view of an apparatus having an elongate member 332 and a tubular distal porous drain structure 336 that defines an inner space 339 and with a sheath 337 similar to the sheath 317, except that the sheath 337 only partially covers the tubular distal porous drain 336.
  • the sheath 337 covers one side of the tubular distal porous drain 336, leaving the opposite side of the tubular distal porous drain 336 exposed.
  • FIG. 3E1 shows an end view and 3E2 shows a side view of an apparatus having an elongate member 342 and a tubular distal porous drain 346 that defines an inner space 349 and with a sheath 347 similar to the sheath 337, except that the sheath 347 covers two sides of the tubular distal porous drain 346.
  • the sheath 347 forms two slits 345a and 345b of exposure along the tubular distal porous drain 346.
  • FIGS. 4A1-4E2 show distal end views and side views of additional example apparatuses having different distal porous drains.
  • FIG. 4A1 shows a distal end view
  • 4A2 shows a side view of an apparatus having an elongate member 412 and a tubular distal porous drain 406 similar to the tubular distal porous drain 306 (FIG. 3A), but where the distal end is closed.
  • the distal porous drain in this example may include one or more internal layers (not visible in this example), as described above; the distal end may be closed by a single layer or multiple layers of porous material (or by a non-porous material).
  • FIG. 4B 1 shows a distal end view and 4B2 shows a side view of an apparatus having an elongate member 412 and a tubular distal porous drain 416 similar to the tubular distal porous drain 406 except that the tubular distal porous drain 416 has a flat outer shape (e.g., by pinching the distal end closed).
  • FIG. 4C1 shows a distal end view and 4C2 shows a side view of an apparatus having an elongate member 422 and a distal porous drain 426 that is non-tubular.
  • the non-tubular distal porous drain 426 has a porous material throughout the thickness of the distal porous drain 426 and does not include an inner lumen.
  • FIG. 4D1 shows a distal end view and 4D2 shows a side view of an apparatus having an elongate member 432 and a distal porous drain 436 similar to the non-tubular distal porous drain 426 except that the distal porous drain 436 has a flat outer shape.
  • FIG. 4E1 shows a distal end view and 4E2 shows a side view of an apparatus having a first elongate member 442 and an invertible tube distal porous drain 446.
  • the invertible distal porous drain 446 is a rollable tube that is configured to invert by translating a second elongate member 441 with respect to the first elongate member 442.
  • a first end of the distal porous drain 446 is coupled to the first elongate member 442 and a second end of the distal porous drain 446 is coupled to the second elongate member 441.
  • the tubular distal porous drain 446 allows the tubular distal porous drain 446 to invert upon distal/proximal relative movement between the first elongate member 442 and the second elongate member 441.
  • the invertible distal porous drain 446 has a round outer shape.
  • the invertible distal porous drain has a different outer shape, such as a flat outer shape (e.g., like the flat outer shape of the tubular distal porous drain 416).
  • the distal porous drain may have a free (e.g., distal) end (e.g., uncoupled to second elongate member 441).
  • FIGS. 5A1-5A4 show an example of how an apparatus with a tubular distal porous drain 506 can provide fluid paths for drawing 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 apparatus when a negative pressure is applied within the elongate member 502 (e.g., as indicated by arrows).
  • the negative pressure creates a flow 550 of fluid and/or gas though the network of pores of the porous walls 516, 555 of tubular distal porous drain 506 and into an inner space 509 (e.g., lumen) of the tubular distal porous drain 506.
  • the flow 550 is directed proximally toward the elongate member 502 and eventually out of the body cavity being drained and/or contracted.
  • some of the flow 550 may be directed axially along/between the porous walls 516, 555 of tubular distal porous drain 506 in the proximal direction toward the elongate member 502.
  • FIGS. 5 A3 and 5A4 show a distal end view and a side view of the apparatus when at least a portion of the tubular distal porous drain 506 is radially compressed/flattened such that the inner space 509 is reduced or eliminated.
  • the flow 550 of fluid and/or gas can flow axially along the porous wall 516, 555 of tubular distal porous drain 506 in the proximal direction toward the elongate member 502 even though the inner space 509 is reduced or eliminated.
  • This aspect may allow the apparatus to function in situations where at least a portion of the tubular distal porous drain 506 becomes compressed by surrounding tissue while in the body cavity.
  • the network of pores in the porous walls 516, 555 provides many nooks and crannies down the length of the tubular distal porous drain 506 that can create a wicking effect, which may cause the fluid to travel faster.
  • FIGS. 6A-6C show partially transparent side views an example apparatus 600 that includes an invertible tubular distal porous drain 606.
  • the apparatus 600 includes a tubular distal porous drain 606 having a first end 607 coupled to a distal end region of a first (e.g., outer) elongate member 603, and having a second end 609 coupled to a distal end region of a second (e.g., inner) elongate member 602.
  • FIG. 6A shows the apparatus 600 in a state where the second elongate member 602 has been pushed distally relative to the first elongate member 603 to extend the second end 609 of the distal porous drain 606 distally (e.g., into a body cavity).
  • the distal porous drain 606 may take on a mostly single-walled tubular shape with the second elongate member 602 extended into a first lumen 611 of the tubular distal porous drain 606.
  • a distal end of the second elongate member 602 is positioned near a distal end of the first elongate member 603 to maximize a length of the distal porous drain 606 extending distally from the first elongate member 603 in the double-walled tubular configuration.
  • 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.
  • the distal porous drain 606 may be stopped and/or locked in the double-walled tubular configuration (e.g., and with the second elongate member 602 fully withdrawn distally within the first elongate member 603), such as shown in FIG. 6B.
  • the distal porous drain 606 may be stopped and/or locked in a distally extend configuration where the second elongate member 602 is distally extended with respect to the first elongate member 603, such as shown in FIG. 6A, and/or in a withdrawn configuration where the distal porous drain 603 is inverted and withdrawn into the lumen of the first elongate member 603, such as shown in FIG. 6C.
  • FIG. 6C shows the apparatus 600 where the second elongate member 602 has been pulled further proximally such that the distal porous drain 606 is almost fully inverted, thereby mostly taking on a single-walled tubular shape that is inverted (compared to FIG. 6A) that forms a third lumen 628.
  • the distal porous drain 606 is also mostly withdrawn within the first elongate member 603. Further proximal movement of the second elongate member 602 can fully withdraw the distal porous drain 606 within the first elongate member 603 in the inverted tubular state.
  • the apparatus 600 may be configured to apply a negative pressure on the invertible tubular distal porous drain 606 at any state of inversion.
  • the distal porous drain 606 may be beneficial to apply suction when the distal porous drain 606 is fully extended distally (e.g., FIG. 6A) to access more distal regions of a body cavity.
  • the non-invertible distal porous drain may have a distal end that freely extends from the elongate member (e.g., second elongate member). That is, the distal end of the non-invertible distal porous drain may be uncoupled to an elongate member. In some cases, this may allow the non-invertible distal porous drain to bend and conform more easily around body tissues.
  • the distal porous drain may be made of a textile (e.g., mesh) material.
  • the textile is a woven tube (e.g., 5 to 50 picks per inch (ppi)) with monofilaments warp and weft yarns (e.g., 0.005 inch to 0.1 inch diameter) with an outer diameter ranging from 8 mm to 20 mm.
  • the textile includes a braided material with monofilaments having diameters ranging from 0.005 inch to 0.1 inch, with 50 to 200 ends, 5 to 50 ppi, and an outer diameter ranging from 8 mm to 20 mm.
  • the textile includes PET monofilaments having diameters ranging from 0.005 inch to 0.1 inch knitted in a circular knit (e.g., 36 needle head).
  • the apparatuses described herein may be scaled to a variety of appropriate sizes in order to treat soft tissue regions of different sizes and shapes.
  • the distal porous drain may be between 10 cm and 100 cm long in the delivery configuration (e.g., proximal to distal length).
  • the distal porous drain is formed of a sheet of material having pores formed through it, the sheet may be a film with slits, holes, slots, shaped holes, etc. formed through the sheet in a pattern.
  • the pattern pores in 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.).
  • any of the apparatuses may include one or more sealing features that help to seal the apparatus against tissue, for example within a channel, so that a negative pressure may be formed for sufficient drainage and/or contraction of the body cavity.
  • FIGS. 7A- 7C show an example apparatus 700 having a sealing feature, and an example use of the apparatus in a soft tissue region of a body.
  • FIG. 7A shows a side and partially transparent view of the apparatus 700, which includes a first (e.g., outer) elongate member 703 and a second (e.g., inner) elongate member 702 and a distal porous drain 706 coupled to a distal region of the second elongate member 702.
  • a plug 730 (also referred to as an occluder) is positioned around a portion of the first elongate member 703 proximal to the distal porous drain 706.
  • the plug 730 may be made of an elastic body made of an elastic material (e.g., foam or sponge) that can be radially compressed (e.g., when positioned within and removed from the channel 722) and resume an expanded state to create a seal against tissue walls.
  • the plug 730 may include one or more covers that is/are configured to apply a radial compressive force on the elastic body to reduce the outer diameter of the plug 730.
  • the plug 730 may be arranged such that the lumen of the first elongate member 703 passes through the plug 730, thereby allowing the second elongate member 702 to pass through and for suction to be applied to the distal porous drain 706 via the first elongate member 703 or the second elongate member 702.
  • FIG. 7B shows a cross section view of a soft tissue region of a body that includes a cavity 720 and a channel 722 that leads to the cavity 720.
  • the soft tissue region may be a surgical site, such as a postpartum uterus or a site of removal for tumor.
  • the channel 722 may include a portion of a vaginal canal and the cavity may include a postpartum uterus.
  • FIG. 7C shows the apparatus 700 after being inserted within the body region and as a negative pressure is applied.
  • the distal porous drain 706 is positioned within the cavity 720 and with the first elongate member 702 having the plug 730 positioned within the channel 722.
  • the diameter of the first elongate member 702 may not be large enough to seal off the cavity 720.
  • the plug 730 can be expanded within the channel to form a seal with the walls of the soft tissue walls of the channel 722 so that sufficient negative pressure can form within the cavity 702.
  • a negative pressure may be applied (e.g., through a lumen of the first elongate member 703 and/or the second elongate member 702) to cause fluid and/or gas from the cavity 720 to flow proximally through the distal porous drain 706 and eventually out of the body tissue.
  • the negative pressure applied by the distal porous drain 706 may apply in inward force on the surrounding walls of the cavity 720 (indicated by inward facing arrows), thereby causing the cavity 720 (e.g., uterus) to at least partially contract.
  • the distal porous drain 706 may be retracted from the cavity 720.
  • the second elongate member 702 may be pulled relative to the first elongate member 703 to pull the distal porous drain 706 within the lumen of the first elongate member 703.
  • the negative pressure is optionally maintained within the cavity 720 for a period of time after withdrawing the distal porous drain 706 from the cavity 720.
  • the distal porous drain 706, the second elongate member 702 and the first elongate member 703 may be removed proximally from the cavity 720 and the channel 722.
  • the plug 730 may be radially compressed prior to removal of the first elongate member.
  • the plug 730 is compressed by a covering/sheath that is configured to reduce the radial geometry of the plug.
  • FIG. 8 shows an example apparatus having a plug assembly 830.
  • expansion and contraction of the plug 830 is controlled by axial movement of a proximal connector 838.
  • the plug 830 may include an elastic body (e.g., foam or sponge) that can be radially compressed and expanded.
  • the plug 830 may include a covering 833 that covers the elastic body.
  • the proximal connector 838 may slidably connect a proximal side of the covering 833 to a first elongate member 803, and a distal connector 839 that fixedly connects a distal side of the covering 833 to the first elongate member 803.
  • the covering 833 may be made of any of a number of materials.
  • the covering 833 may include one or more layers of material.
  • the covering 833 may include a sheet of a polymer material (e.g., polyethylene (e.g., light weight), nitrile) and/or a mesh material.
  • At least one layer (e.g., compression layer) of the covering 833 may be axially tightened and loosened to control the size of the outer diameter of the plug 830.
  • the proximal connector 838 may be activated to control the size of the outer diameter of the plug 830 by sliding relative to the first elongate member 803.
  • the proximal connector 838 may be pulled proximally (e.g., by hand or via an actuator) to axially elongate and tighten the covering 833, thereby applying a radial inward pressure on the elastic body of the plug 830.
  • the radially inward pressure can radially squeeze the elastic body and reduce the outer diameter of the plug 830.
  • the covering 833 includes an additional layer or membrane (e.g., fluid barrier layer or membrane) that is configured to provide a fluid barrier and/or improve a seal of the plug 830 with surrounding tissue.
  • a single layer may serve to compress the elastic body and provide a fluid barrier.
  • the outer diameter of the plug 830 may be reduce, for example, during insertion or repositioning of the plug 830 within a body channel.
  • the proximal connector 838 may be released to loosen the covering 833 and release the radial inward pressure on the elastic body of the plug 830, thereby causing the plug 830 to expand and creating a seal against tissue walls within the body channel.
  • the plug assembly 830 includes an opening (e.g., central opening) that accommodates a first elongate member 803, which provides suction to the distal porous drain 806.
  • the apparatus includes an invertible tubular distal porous drain 806 that is configured to transition between a tubular and an inverted tubular state upon proximal and distal movement of a second elongate member 802, which is coupled to the distal porous drain 806.
  • a vacuum port 842 is configured to supply the negative pressure to the distal porous drain 806 via the lumen of the first elongate member 803 and/or the second elongate member 802.
  • FIGS. 10A-10B show another example plug assembly 1030 where an elastic body 934 has a covering 933 that is an expandable mesh.
  • the outer diameter of the elastic body 934 may be reduced by pulling a proximal connector 932 to elongate the covering 933, thereby applying a radially inward force on 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 in the covering 933, thereby releasing the radial inward force on the elastic body 934.
  • the mesh covering 933 is covered with an additional layer that may function as a fluid barrier.
  • FIGS. 10A-10B show another example plug assembly 1030.
  • FIG. 10A shows the plug 1030 in a radially expanded state
  • FIG. 10B shows the plug 1030 in a radially compacted state.
  • the plug 1030 is positioned around an elongate member 1003 (e.g., first elongate member). Distal ends of the compression layer 1033 and the fluid barrier layer 1036 are fixedly coupled to the elongate member 1003 via a first (e.g., distal) connecter 1039.
  • Proximal ends of the compression layer 1033 and the fluid barrier layer 1036 are slidably coupled to the elongate member 1003 to a second (e.g., proximal) connector 1038.
  • the second connector 1038 has an elongated proximal side 1032 that may serve as a handle.
  • the first connecter 1039 and the second connector 1038 may be referred to as cuffs or collars.
  • the first connecter 1039 and the second a connecter 1038 include bands (e.g., elastic bands) and/or washers.
  • Driving the second connector 1038 in a proximal direction e.g., by pulling the handle 1032 by hand or by an actuator), as shown in FIG.
  • the compression layer 1033 causes the compression layer 1033 to elongate and apply a radial compression force on the elastic body 1034, thereby reducing the outer diameter of the elastic body 1034 and the plug 1030.
  • Releasing the proximal axial force placed on the second connector 1038 e.g., by releasing the handle 1032
  • the radially expanded state of the elastic body 1034 may be reinforced based on an extent to which the second connector 1038 is axially displaced distally and an amount of axial force placed on the elastic body 1034 distally.
  • the plug assembly 1030 may include one or more stops and/or locks that limit and/or lock the axial position of the second a connecter 1038 (and the handle 1032) relative to the first connecter 1039.
  • the second connecter 1038 may include a lock that releasably locks an axial position of the second connecter 1038 relative to the elongate body 1003.
  • the elastic body 1034 may be locked in an a radially expanded state (e.g., FIG. 10A) or a radially compressed state (e.g., FIG. 10B).
  • the fluid barrier layer 1036 may be a thin layer of fluid resistant material.
  • the fluid barrier layer 1036 may be made of polyethylene (e.g., light weight polyethylene), nitrile, or nitrile-like low stretch material.
  • the thickness of the fluid barrier layer 1036 may vary depending on the material. In some examples, the fluid barrier layer 1036 has a thickness ranging between about 0.0001 inches to 0.01 inches).
  • the compression layer 1033 may have a relatively high tensile strength so that it can apply a radially inward pressure on the elastic body 1034. In some cases, the compression layer 1033 is a tubular mesh.
  • the compression layer 1033 is a tubular fabric braid having a diameter ranging between about 3 inches and 5 inches and with about 100-200 monofilaments having diameters ranging between about 0.005 inches and 0.1 inches.
  • the elastic body 1034 may be made of any of a number of elastic materials, such as a polymer foam or sponge material.
  • the elastic body 1034 has flat sides (in the axial direction) to create predetermined angle 1031 between the elastic body 1034 and the elongate member 1003. In some cases, the predetermined angle is about 90 degrees (perpendicular), which may allow for the most diameter change of the elastic body 1034 per pull length.
  • FIGS. 11A-11C show an example plug assembly 1130 that is similar to the plug assembly 1030 except that the plug assembly 1130 includes three elastic bodies 1134a, 1134b, 1134c that are configured to provide a reinforced expansion force when expanded.
  • FIG. 11A shows the plug assembly 1130 in an expanded state
  • FIG. 11B shows the plug assembly 1130 in a reinforced expanded shape
  • FIG. 11C shows the plug assembly 1130 in a compacted state.
  • the elastic bodies 1134a, 1134b, 1134c may be configured to slide axially with respect to the elongate member 1103 such that driving the second connector 1132 distally (e.g., by pushing the handle 1132 distally) can drive the first connecter 1138 toward the second a connecter 1139, thereby compressing the elastic bodies 1134a, 1134b, 1134c on each other and reinforcing the expanded state of the plug 1030.
  • washers 1140 and 1141 are positioned on proximal and distal sides, respectively, of the elastic bodies 1134a, 1134b, 1134c to enhance the pushing force.
  • the first a connecter 1138 and the second a connecter 1139 and/or the washers 1140 ad 1141 may be configured to lock the elastic bodies 1134a, 1134b, 1134c in the radially expanded state (FIG. 11 A), reinforced radially expanded state (FIG. 11B) and/or the radially reduced state (FIG. 11C).
  • the plug assembly 1130 includes a covering, which includes a compression layer 1133 and a fluid barrier layer 1136.
  • FIGS. 12A-12B show an example plug assembly 1230 that is similar to the plug assembly 1030 except that the plug assembly 1230 is configured to fold an 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.
  • the first connector 1239 prevents axial movement of the elastic body 1234 in the distal direction and the elastic body 1234 folds radially inward in (e.g., in a proximal direction) to reduce the diameter of the plug 1230, as shown in FIG. 12B.
  • a stop 1240 (e.g., band or washer fixedly coupled to the elongate member 1203) may prevents the elastic body 1234 from moving axially in the proximal direction when the handle 1232 is pulled proximally.
  • the elastic body 1234 may be fixed to the elongate member 1203, for example, by an adhesive (e.g., glued). Once the handle 1232 is released, the compressive force is released so that the elastic body 1234 can retain its expanded state (FIG. 12A).
  • the plug assembly 1230 includes a covering, which includes a compression layer 1233 and a fluid barrier layer 1236.
  • FIGS. 13A-13B show an example plug assembly 1330 that is similar to the plug assembly 1030 except that the plug assembly 1330 is configured to compress an elastic body 1334 by rotating a second connector 1338 (e.g., by rotating a handle 1332) with respect to an elongate member 1303.
  • Rotating the second connector 1338 with respect to an elongate member 1303 causes a compression layer 1333 to twist and create an inward compression force on the elastic body 1334, as shown in FIG. 13B.
  • the plug assembly 1330 may include one or more locks configured to lock the elastic body 1334 in a radially expanded and/or a radially compressed state.
  • the radial position of the handle 1332 with respect to the elongate member 1303 may be locked (e.g., by a lock on the second connector 1338 and/or a separate lock) to keep the compression layer 1333 in a twisted and/or untwisted state.
  • the second connector 1338 is allowed to unwind, the compression force is released and the elastic body 1334 returns to an expanded state (e.g., FIG. 13A).
  • the plug assembly 1330 includes a covering, which includes the compression layer 1333 and a fluid barrier layer 1336.
  • FIGS. 14A-14D show an example plug assembly 1430 that is similar to the plug assembly 1030 except that an elastic body 1434 is positioned axially near or at the distal end of the elongate member 1403.
  • the elastic body 1434 may be positioned axially nearer to the distal porous drain (not shown in FIGS. 14A and 14B), as described herein.
  • a distal portion of the elastic body 1434 is positioned distally past a distal end of the elongate member 1403 when in an expanded state (FIG. 14A).
  • the more distal position of the elastic body 1434 may be well suited for situations where the body channel is short, such as a relatively short cervical canal.
  • the elastic body 1434 may be configured to axially shift in the proximal direction relative to the distal end of the elongate member 1403, as shown in the example of FIG. 14B.
  • the plug assembly 1430 includes a covering, which includes the compression layer 1433 and a fluid barrier layer 1436.
  • FIGS. 14C and 14D the plug assembly 1430 coupled to a distal porous drain 1406.
  • the distal porous drain 1406 is a tubular structure that is configured to invert, as described herein.
  • FIG. 14C shows the distal porous drain 1406 extended distally past the plug 1430, for example, when suction is applied to drain and/or contract the body cavity (e.g., uterus).
  • a second (e.g., inner) elongate member 1402 which is coupled to the distal end of the tubular distal porous drain 1406, may be pulled proximally relative to the elongate member 1403 (e.g., outer elongate member), thereby causing the tubular distal porous drain 1406 to invert and retract proximally within the elongate member 1403.
  • FIG. 15 show example shapes (axial and radial cross sections) of elastic bodies when in expanded states.
  • the example elastic body of Al and A2 has a rectangular axial cross section (axially with respect a central opening 1501 for the elongate body) as shown in Al, and a round radial cross section (radially with respect to the central opening 1501) as shown in A2.
  • the example elastic body of Bl and B2 has a rectangular axial cross section as shown in Al, and an oblong (e.g., oval) radial cross section as shown in B2.
  • the example elastic body of Cl and C2 has a rectangular axial cross section as shown in Cl, and a round radial cross section as shown in C2, with radially extending slits or openings 1555.
  • the example elastic body of DI and D2 has a round axial cross section as shown in DI, and a round radial cross section as shown in D2.
  • the example elastic body of El and E2 has an oblong (e.g., oval) axial cross section as shown in El, and a round radial cross section as shown in E2.
  • any of the apparatuses described herein may include one or more locks that is/are configured to hold a relative axial position of the distal porous drain relative to the first elongate member, and/or hold the plug in a radially expanded and/or radially compressed state.
  • the lock(s) may allow the relative positions to be held until additional force is applied to overcome the holding force.
  • the lock may include a ratcheting element at a proximal end of the apparatus (e.g., on or part of a handle at the proximal end).
  • FIGS. 16A-16B shows an example invertible tubular distal porous drain 1606 that is configured to take on a bent shape when extended from a first elongate member 1603.
  • FIG. 16A shows the tubular distal porous drain 1606 in a mostly inverted state retracted within the first elongate member 1603.
  • FIG. 16B shows the tubular distal porous drain 1606 after being advanced distally with respect to the first elongate member 1603 (e.g., by pushing a second elongate member 1602).
  • the tubular distal porous drain 1606 is biased to take on a bent configuration (e.g., “c” shape) when expanded.
  • a bent configuration e.g., “c” shape
  • tubular distal porous drain 1606 may be flexible to comply with body tissue, thereby preventing damage to the tissue.
  • the distal porous drains described herein may be configured to take on any of a number of bent shapes (e.g., banana shape, “s” shape, “j” shape, etc.) and are not limited to the “c” shape of the example of FIGS. 16A and 16B.
  • the distal porous drain may have a multiple layers (e.g., may be formed of an inverted mesh), and a first end (e.g., proximal end) that is coupled to a distal region of an elongate member and a second end (e.g., distal end) that freely extends from the elongate member.
  • the distal porous drain may have a tubular shape with porous walls, where the porous walls terminate at the distal end of the distal porous drain.
  • the distal porous drain is a non-tubular structure.
  • the distal porous drain has porous walls that double back at a distal end of the distal porous drain (e.g., invertible distal porous drain).
  • the elastic body may be configured to radially compress and/or fold to reduce the diameter of the plug (e.g., for insertion within the channel).
  • the elastic body may be made of an elastic material, such as a foam (e.g., porous polymer material).
  • the plug may optionally include a fluid barrier (e.g., layer) to prevent fluid from contacting the elastic body and/or compression layer.
  • the plug may optionally include a lock that is configured to lock the plug in a radially expanded and/or compressed state.
  • the apparatus may be configured to activate the plug by a handle that is configured to elongate, shorten and/or twist the compression layer.
  • the distal porous drain is retracted into the elongate member, for example, by pulling an a second (e.g., inner) elongate member that is coupled to the distal porous drain.
  • the distal porous drain may be inverted upon withdrawal into the elongate member.
  • the negative pressure is optionally maintained within the body region for a period of time 1909 after withdrawing the distal porous drain from the body region. In certain situations this may help to contract the body region and mitigate hemorrhaging, such as uterine hemorrhaging in some postpartum situations.
  • any of the surgical drain apparatuses described herein may include a connector for quickly and securely (but releasably) coupling the distal porous drain structure to a source of negative pressure.
  • any of these apparatuses may include a sealing connector (also referred to in some examples as a sealing cap).
  • FIGS. 20A- 20B illustrate another example of a portion of a surgical drain apparatus including a removable sealing cap.
  • the surgical drain apparatus may include plug assembly, which is not shown in FIGS. 20A-20B for simplicity.
  • the sealing connector 2000 in this example is shown connected to (or may be integral with) a proximal end of the surgical drain apparatus.
  • FIGS. 20A-20B shows the rolling drain 2005’ in a fully deployed state, so that, as described above the tubular mesh is fully extended from the apparatus and negative pressure (e.g., vacuum) can be applied through the apparatus and distributed within the body lumen by the two-layered cylindrical mesh structure of the rolling drain.
  • negative pressure e.g., vacuum
  • FIGS. 20A-20B a negative pressure tube 2013 is coupled to the pressure connector and therefore pressure is applied through the lumen of the inner shaft 2007 and out of the rolling drain.
  • the sealing connector may include on or more gaskets (e.g., ring gaskets 2001) to help form and/or maintain the seal.
  • the sealing connector e.g., sealing cap
  • the sealing connector may also be coupled to an inner rigid shaft or member 2123 (e.g., an inner rigid rolling drain deployment shaft).
  • Advancing 2122 the sealing connector distally relative to the outer shaft 2003 may result in both extending/deploying the distal porous drain structure (e.g., rolling drain) 2105 and may seal the negative pressure port 2113 in communication with the lumen of the tubular outer shaft so that suction may be applied through the flexible distal porous drain structure, a shown in FIG. 2 IB.
  • sealing connector (sealing cap 2200) is shown.
  • the sealing connector in this example is configured to connect and seal over the outer shaft of the elongate member 2203 and also connect proximally at a negative pressure port 2213 to a source of negative pressure.
  • the sealing connector 2200 includes a tapered inner surface 2219 into which the proximal end of the outer shaft can fit to form a seal.
  • the tapered inner surface may also include one or more gaskets (e.g., ring gaskets 2301) as shown in FIGS. 23A-23B.
  • gaskets e.g., ring gaskets 2301
  • the sealing connector also couples to an elongate inner member 2223 that is proximally connected to one end of the distal porous drain structure (e.g., rolling drain) 2205, 2205’.
  • the inner member 2223 distally deploys the flexible distal porous drain structure (rolling drain) as shown in FIG. 23B.
  • connecting 2222 the sealing connector to the outside of the elongate outer shaft 2203 may both deploy the rolling drain and couple the rolling drain at the distal end of the apparatus to the source of suction (negative pressure) at the proximal end of the apparatus.
  • FIGS. 23A-23 are similar to the example shown in FIGS. 21A-21B.
  • the sealing connector 2300 also includes a negative pressure port 2313 to couple to the source of negative pressure (e.g., via tubing) and an inner sealing surface 2319.
  • the inner sealing surface is not tapered but instead includes a pair of ring gaskets 2301 (one or more ring gaskets may be used).
  • the outer elongate shaft 2303 of the apparatus may be inserted into and form a seal with the sealing connector within the opening into the sealing connector.
  • the sealing connector may optionally connect to an inner shaft 2223 in examples 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 may seal the inner lumen of the outer shaft in communication with the negative pressure port and thereby a source of negative pressure.
  • Any of the example apparatuses shown in FIGS. 20A-20B, 21A-21B, 22A-22B, and 23A-23B may also include a plug assembly (not shown).
  • FIGS. 24A-24F illustrate an example of a sealing connector that may be used with any of the surgical drain apparatuses described herein.
  • the sealing connector 2421 is shown coupled over the distal end of an outer shaft 2403 of an apparatus, forming a seal between the sealing connector (and therefore a source of negative pressure coupled to the negative pressure port 2413 of the sealing connector and the inner lumen of the outer shaft 2403.
  • the exemplary apparatus shown in FIGS. 24A-24F includes an infer shaft that is coupled to one end of the flexible distal porous drain member (not shown) so that it may be retracted or deployed.
  • any of these sealing connectors may also include a grip region 2414 (e.g., finger grip region) to make it easier to handle the connector when taking it off or putting it onto the outer shaft.
  • FIG. 24C shows an end view from the distal end of the apparatus, including the suction lumen 2416 (also shown in FIGS. 24E and 24F).
  • the proximal end in this example forms the negative pressure port 2413 and may be tapered to fit into tubing connected to the source of negative pressure (e.g., suction).
  • the sectional view in FIG. 24F also shows the tapered inner surface of the distal opening, for engaging with the outer surface of the outer shaft 2403, and a deployment shaft engagement region 2418 for engaging an inner shaft as described above.
  • the deployment shaft engagement region is optional, as in some examples the sealing connector is for use with an apparatus that includes a static (non-rolling) distal porous drain member (as described above, and shown in the examples of FIGS. 32A-32C, 33A-33B, 34A-34B, 35, 36A- 36B, 37A-37B, 41A-41C and 42A-42B.
  • a static (non-rolling) distal porous drain member as described above, and shown in the examples of FIGS. 32A-32C, 33A-33B, 34A-34B, 35, 36A- 36B, 37A-37B, 41A-41C and 42A-42B.
  • FIGS. 25A-25E illustrate another example of a sealing connector (sealing cap) as described herein.
  • the sealing connector 2500 (sealing cap) includes a negative pressure port 2513 at the proximal end for coupling to a source of negative pressure, a finger grip region 2514, and a distal engagement surface for sealing to the inner and/or outer elongate shafts of the apparatus in order to couple the source of negative pressure to the distal porous drain member.
  • the sealing connector 2500 is shown connected to the outer shaft 2503 of the surgical drain apparatus 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 may have a non-smooth profile in order to form a seal between the inner diameter of the outer shaft 2503 and the outer sealing surface 2524 of the distal engagement surface.
  • the apparatus includes an inner deployment shaft for deploying or retracting the distal porous drain member.
  • the sealing connector may also include an optional internal deployment shaft engagement region 2518, as shown in FIG. 25E.
  • the sealing connectors described herein may also be configured for use with a static (non-rolling) distal porous drain member.
  • the surgical drain apparatuses described herein may be configured to include a compressible and expanding, e.g., self-expanding, plug assembly.
  • the plug assembly may include an annular foam member that may extend at least partially around the outer surface of the elongate outer member of the apparatus, in order to seal or otherwise prevent air and/or fluid from passing out of the region being drained.
  • FIGS. 26A-26H illustrate side-views of various examples of annular foam member.
  • the plug or a portion of a plug assembly may include a ring-shaped foam material (shown in side-views in FIGS.
  • the plug assembly may include any appropriate material, including foam material.
  • the foam materials may be open cell foam 2651 material (FIG. 26A) or closed cell foam 2652 materials (FIG. 26B).
  • FIGS. 26C-26H the generic foam 2658 material may be either open or closed cell foam.
  • FIG. 26C shows a portion of a plug assembly including a fluid-impermeable material covering one side e.g., the distal side, of the foam plug. This configuration may be helpful to maintain the seal of the body channel or passage even when using an open cell foam.
  • FIG. 26C shows a portion of a plug assembly including a fluid-impermeable material covering one side e.g., the distal side, of the foam plug. This configuration may be helpful to maintain the seal of the body channel or passage even when using an open cell foam.
  • the plug assembly includes a fluid-impermeable covering on the opposite side (e.g., proximal side) of the foam plug.
  • the covering may be biocompatible polymer (e.g., silicone, latex, etc.)
  • the covering material may have a relatively high durometer (e.g., on the Shore 00 scale of between about 30 - 45, between about 40-60, etc.).
  • the foam may be a viscoelastic polyurethane foam, or low-resistance polyurethane foam.
  • the foam includes a barrier on one side, but is open on other sides (which may help with compression/expansion in open-celled foams).
  • the plug assembly including in some examples a foam ring, may be mounted onto the tubular body of the apparatus, as described in detail above.
  • the plug assembly is mounted to the tube; in some examples the plug assembly may be slideably over the tube, to allow adjustments to the patient anatomy while still forming a plug.
  • the barrier material may be applied by spraying, dipping, painting, etc.
  • the barrier 2653, 2653’, 2655 may be referred to as a skin.
  • the barrier or cover 2565 over or around the foam 2658 subassembly of the plug may be a cover.
  • the cover 2656 may be loosely applied, as shown in FIG. 26F, or may be intimately applied (e.g., attached) to the foam as shown in FIG. 26H.
  • one or both lateral sides of the foam plug sub-assembly may be covered, as shown in FIG. 26G, showing a partial cover 2662.
  • the skin or cover material described herein, an in particular those that are intimately attached to the surface of the foam material may also help distribute the plugging force across the surface of the plug once it is inserted into the body region and expanded or allowed to expand.
  • FIGS. 27A-27G illustrate examples of apparatuses showing different plug assemblies formed of one or more plug sub-assemblies similar to those shown in FIGS. 26A-26H.
  • plug sub-assemblies of different sizes (heights, widths and/or thicknesses) and materials (including different foam materials) may be used, and these different plug sub-assemblies may be differently spaced along the length of the outer shaft of the apparatus (or may be adjustably spaced).
  • the apparatuses shown each include an outer shaft 2703 and a distal porous drain structure, configured as a rolling drain (though non-rolling distal porous drain structures may be used instead), that is connected to an inner member (e.g., a hollow soft polymeric tube inner shaft 2707).
  • the plug assembly 2732 includes a plurality (e.g., 5 are shown) of foam 2758 rings or discs that are positioned on the outer shaft with a gap or space between each.
  • a cover or skin may be applied over all or some of these foam sub-assemblies.
  • FIG. 27B shows an example of an apparatus similar to that shown in FIG. 27A, but without any spacing between the foam plug sub-assemblies of the plug assembly 2732.
  • the foam plug sub-assemblies are wider than those shown in FIGS. 27A-27B, but are arranged as shown in FIG. 27B.
  • the foam 2758 sub-assemblies of the plug 2732 assembly are similar in width but have different heights.
  • FIG. 27D shows an example that is similar to that shown in FIG. 27D but with both different height and widths, with the foam 2758 sub-assemblies of the plug assembly 2732 arranged in increasing height and increasing width in the distal-to-proximal direction.
  • FIGS. 27E and 27F show an arrangement of foam 2758 subassemblies in which the height of the foam sub-assemblies increases to a maximum and then decreases along the proximal-to-distal length; in FIG. 27E the arrangement is symmetrical, while in FIG. 27G the foam 2758 sub-assemblies have a larger width in the proximal direction of the plug assembly 2732.
  • FIG. 28 illustrates an example in which the foam sub-assemblies of the plug assembly 2832 have different mechanical properties.
  • the plug 2832 include a proximal-most foam sub-assembly that is formed of a soft foam material 2859, while each adjacent foam sub-assembly has a decreasing softness.
  • the middle foam subassembly 2859’ is a medium hard foam material
  • the distal-most foam sub-assembly 5859” is a hard foam material.
  • the plug 2832 is positioned on the outer shaft 2803 of the apparatus.
  • this example also includes a distal porous drain structure 2805’ configured as a rolling drain and including an inner member 2807, non-rolling distal porous drain structures may be used instead.
  • FIGS. 29A-29B, 3OA-3OB and 31A-31D illustrate different examples of apparatuses using adhesives used to secure the foam sub-assemblies forming the plug assembly to the outer shaft of the apparatus.
  • a distal porous drain structure 2905’, 3005’ configured as a rolling drain and including an inner member 2907, 3007, non-rolling distal porous drain structures may be used instead.
  • the adhesive material may be applied as a tape adhesive, a liquid (e.g. polymerizing) adhesive, etc.
  • an adhesive 2964, 2964’ extends from the shaft of the outer elongate shaft 2903 up and along a portion of both the proximal and distal faces of the foam sub-assembly 2959.
  • the plug assembly 2932 includes a plurality (e.g., two, or in some examples more) of foam sub-assemblies 2959 that are adhesively secured to the shaft of the elongate outer shaft 2903, the proximal face of the proximal-most foam subassembly and the distal face of the distal-most foam sub-assembly, and each foam sub-assembly is adhesively secured to its neighbor (e.g. between the foam sub-assemblies).
  • a plurality e.g., two, or in some examples more
  • the extent of the adhesive may be different between the proximal and distal faces of the foam sub-assembly/sub-assemblies 3064 forming the plug assembly 3032.
  • the adhesive on the proximal face 3064 is more extensive (e.g., extending over all or most of the proximal face) than the adhesive on the distal face 3064’.
  • FIG. 30B this arrangement is reversed. In both cases, the adhesive 3064, 3064’ secures the foam subassemblies 3059 of the plug assembly 3032 to the outer shaft 3003.
  • FIGS. 31A-31D illustrate end-face views (e.g., looking from the distal end face towards the proximal direction) of different examples of adhesive attached to a end face of a foam sub-assembly.
  • the adhesive 3164 is attached around and to the shaft 3171 (e.g., outer shaft) and to the face of the foam sub-assembly 3159.
  • the adhesive 3164 is arranged in a single bar-shaped configuration.
  • FIG. 3 IB the adhesive 3164 is arranged in a plus (+) shaped configuration.
  • FIG. 31C the adhesive 3164 is arranged in a circular configuration having a radius that is less than the radius of the foam sub-assembly 3159, while in FIG. 3 ID the adhesive 3146 has the same radius as the foam sub-assembly 3159.
  • FIGS. 32A-32C schematically illustrate one example of a surgical drain apparatus as described herein, in which the distal porous drain structure 3282 is formed of an inverted tube of flexible porous material (e.g., a mesh or other fabric material, including knitted, woven, and/or braided materials) that inverts over itself (e.g., inside out).
  • a mesh or other fabric material including knitted, woven, and/or braided materials
  • An inverted, two-layer tube of material may be configured as shown in FIG. 32A, so that the first and second ends of the tubular material 3282 are both attached to the outer shaft 3203.
  • the dimensions of the apparatuses shown herein, including in FIGS. 32A-32C are not intended to be exact, but may vary.
  • the distal porous drain structure may extend between 1- 15 inches or more (e.g., between 1-14 inches, between 1-13 inches, between 1-12 inches, between 1-11 inches, between 1-10 inches, between 1-9 inches, etc.).
  • the distal porous drain structure may be generally flexible and compressible (e.g., when inserted into the tissue region, it may be compressed down), but typically has sufficient column strength so that it may be inserted into the body region manually without bending or collapsing. In some cases, the user may manually guide (using a gloved hand) insert the non-rolling distal porous drain structure into the body.
  • An apparatus including a non-rolling distal porous drain structure may include any of the plug assemblies described herein, and/or may include a sealing connector as described above.
  • FIGS. 32A-32C illustrate examples of apparatuses having non-rolling distal porous drain structures 3282 and plug assemblies 3232 similar to those shown and described above in FIGS. 27A-27C, formed of a plurality of foam sub-assemblies 3259 arranged along the outer shaft 3203.
  • FIGS. 33A-33B and 34A-34B show apparatuses having non-rolling distal porous drain structures 3382, 3482 with plug assemblies 3332, 3432 attached to the outer shaft 3303, 3403 in which each plug assembly is formed of a plurality of form subassemblies 3359, 3459 arranged similar to those shown in FIGS. 27D-27G.
  • FIGS. 35, 36A-36B and 37A-37B show examples of surgical drain apparatuses corresponding to those of FIGS. 28, 29A-29B and 3OA-3OB, respectively, but with a non-rolling distal porous drain structure instead of a rolling distal porous drain structure (and therefore without an inner member).
  • a non-rolling distal porous drain structure 3582, 3682, 3782 may be formed by inverting a porous mesh tubular material over itself at a distal face, with the ends of the mesh tube connected to the outer shaft 3503, 3603, 3703 of the apparatus, forming a two-layer tube.
  • the mesh material may be knitted, woven and/or braided.
  • any of these apparatuses may also include a plug assembly 3532, 3632, 3732 that may include one or more foam sub-assemblies 3559, 3659, 3759 that may be adhesively secured to the outer shaft by an adhesive material 3664, 3664’, 3764, 3764’.
  • the distal porous drain structure may include a distal porous drain structure that is a rolling drain structure in which the inner member of the distal porous drain structure may extend beyond the distal end of the outer elongate shaft. This may provide additional column strength when deploying the apparatus into a body region.
  • a distal porous drain structure that is a rolling drain structure in which the inner member of the distal porous drain structure may extend beyond the distal end of the outer elongate shaft. This may provide additional column strength when deploying the apparatus into a body region.
  • 38A-38C illustrate one example of a surgical drain apparatus in which the distal porous drain structure is formed of a tubular mesh material that is attached at one end to an outer shaft 3888, configured as a retractable sheath, and the opposite end region of the distal porous drain structure is attached to a hollow tubular inner shaft member 3807 that is initially in an extended configuration so that the distal end region of the inner shaft member extends distally beyond the outer (e.g., sheath) member, as shown in FIG. 38A.
  • the distal porous drain structure may have a relatively high column strength and may be inserted in this configuration into the body.
  • the outer (e.g., sheath) member 3888 may be move distally to allow the distal porous drain structure to expand and/or conform to the body region and to form suction passageways through the distal porous drain structure.
  • the inner shaft member 3807 may be retracted proximally to form the two-layered tube of the distal porous drain structure so that suction can be applied through the distal porous drain structure.
  • FIG. 38B shows the distal advancement of the outer member 3888
  • FIG. 38C shows the proximal retraction of the inner member.
  • the cover 3982 may completely or partially cover the compressible/self-expanding sub-assembly.
  • the cover may be one or more straps, as shown in FIGS. 40A- 40B.
  • the surgical drain apparatus includes an outer shaft 4003, a distal porous drain structure (shown as a rolling drain, though non-rolling drains may be used) 3905, an inner shaft 4007 and a plug assembly 4032.
  • the plug assembly includes a compressible/self-expanding foam sub-assembly 4059.
  • each strap is attached at a distal end 4058 to the outer shaft and is slidably coupled at a proximal end region to the outer shaft.
  • the straps may be pulled by sliding the proximal end 4057 proximally (to the left in FIGS. 40A-40B) to place them under tension to collapse the plug sub-assembly 4059, as shown in FIG. 40B. releasing the proximal end 4057 of the straps allows the plug sub-assembly to self-expand, as shown in FIG. 40A.
  • proximal end regions of the cover may be coupled to a ring or other slider that may be on the outer shaft to allow it/them to slide and/or be gripped, e.g., by a user’s hand.
  • the plug assembly may be configured to be removed from the body (e.g., at the end of a procedure) by collapsing with a cover and/or one or more straps.
  • the plug assembly may be removed by controllably deconstructing the plug assembly so that it collapses down and/or can be withdrawn from the channel.
  • FIGS. 41A-41C illustrate examples of plug assemblies that are configured to be removed from a body by pulling on a tether (e.g., string, line, etc.).
  • a tether e.g., string, line, etc.
  • FIG. 41A shows an examples of an apparatus including an outer shaft 4103, a distal porous drain structure 4182 (shown as a non-rolling drain, but which may be alternatively be a rolling drain), and a plug assembly 4032 that is formed of a compressible/self-expanding foam plug sub-assembly 4191.
  • a pull tether 4195 is attached to a proximal portion of the plug assembly. Pulling the pull tether 4195 will remove, and therefore collapse, the plug assembly.
  • the plug assembly is formed by a plurality of plug sub-assemblies that are connected at single discrete points to an adjacent compressible/self-expanding foam plug sub-assembly, as shown in FIG. 41B. In FIG.
  • the plug assembly may be formed of a spiral-shaped sub-assembly 4191 that, when the proximal end is pulled proximally by the pull tether 4195, may unravel the plug assembly as shown in FIG. 41C.
  • the plug assembly may be collapsed by changing the conformation of the plug assembly from a proud configuration, in which the one or more plug sub-assemblies extend proud of the outer shaft, to a collapsed configuration, in which the arrangement of the one or more plug sub-assemblies are arranged in a lower profile.
  • the plug assembly may be collapsed or reduced in radial diameter without compression of the material forming the plug assembly, although it may be compressed as well.
  • the apparatus includes an outer shaft 4203, a distal porous drain structure 4282 (optionally configured as a static or non-rolling drain) and a plug assembly 4232.
  • the plug assembly also includes a tether 4203 extending proximally.
  • a tether 4203 extending proximally.
  • FIG. 42A the plug assembly is shown in a radially expanded, proud configuration.
  • the plug assembly in this example is formed of a foam material that is attached along a first region to the outer shaft, and the foam material is tucked under itself (e.g., is doubled up on itself).
  • the tether is connected to the region that is tucked under, so that pulling the teether proximally untucks the foam material, allowing it to lay more flat against the outside of the outer shaft, as shown in FIG. 42B.
  • the plug sub-assembly may be inverted over itself to form the proud configuration and pulling a tether proximally may un-invert it into the flatter configuration.
  • Any of the methods (including user interfaces) described herein may be implemented as software, hardware or firmware, and may be described as a non-transitory computer-readable storage medium storing a set of instructions capable of being executed by a processor (e.g., computer, tablet, smartphone, etc.), that when executed by the processor causes the processor to control perform any of the steps, including but not limited to: displaying, communicating with the user, analyzing, modifying parameters (including timing, frequency, intensity, etc.), determining, alerting, or the like.
  • a processor e.g., computer, tablet, smartphone, etc.
  • the device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly.
  • the terms “upwardly”, “downwardly”, “vertical”, “horizontal” and the like are used herein for the purpose of explanation only unless specifically indicated otherwise.
  • first and second may be used herein to describe various features/elements (including steps), these features/elements should not be limited by these terms, unless the context indicates otherwise. These terms may be used to distinguish one feature/element from another feature/element.
  • a first feature/element discussed below could be termed a second feature/element
  • a second feature/element discussed below could be termed a first feature/element without departing from the teachings of the present invention.
  • any of the apparatuses and methods described herein should be understood to be inclusive, but all or a sub-set of the components and/or steps may alternatively be exclusive, and may be expressed as “consisting of’ or alternatively “consisting essentially of’ the various components, steps, sub-components or sub-steps.
  • a numeric value may have a value that is +/- 0.1% of the stated value (or range of values), +/- 1% of the stated value (or range of values), +/- 2% of the stated value (or range of values), +/- 5% of the stated value (or range of values), +/- 10% of the stated value (or range of values), etc.
  • Any numerical values given herein should also be understood to include about or approximately that value, unless the context indicates otherwise. For example, if the value “10” is disclosed, then “about 10” is also disclosed. Any numerical range recited herein is intended to include all sub-ranges subsumed therein.

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  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Surgery (AREA)
  • Vascular Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • External Artificial Organs (AREA)
  • Materials For Medical Uses (AREA)

Abstract

L'invention concerne des drains chirurgicaux comprenant une région de drain poreuse distale ayant au moins deux couches poreuses adjacentes à travers lesquelles une pression négative peut être appliquée pour fournir une pression négative uniforme à l'intérieur de la région de corps traitée. Le drain poreux distal peut être conçu pour épouser la forme de la région de corps en cours de traitement.
EP23889480.2A 2022-11-13 2023-11-13 Drains chirurgicaux et procédés d'utilisation Pending EP4615535A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202263424944P 2022-11-13 2022-11-13
PCT/US2023/037222 WO2024102498A2 (fr) 2022-11-13 2023-11-13 Drains chirurgicaux et procédés d'utilisation

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EP4615535A2 true EP4615535A2 (fr) 2025-09-17

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EP23889480.2A Pending EP4615535A2 (fr) 2022-11-13 2023-11-13 Drains chirurgicaux et procédés d'utilisation

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EP (1) EP4615535A2 (fr)
JP (1) JP2025538213A (fr)
CN (1) CN120379706A (fr)
WO (1) WO2024102498A2 (fr)

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN120900025B (zh) * 2025-09-11 2026-03-27 上海交通大学医学院附属瑞金医院 手术烟雾汇流收集装置及其使用方法

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3272386B1 (fr) * 2009-09-30 2024-10-23 Lohmann & Rauscher GmbH & Co. KG Drainage par éponge sous vide
CA2885594A1 (fr) * 2012-09-20 2014-03-27 Gunnar Loske Dispositif de traitement par pression negative et feuille pour la realisation d'un dispositif de traitement par pression negative
US9883877B2 (en) * 2014-05-19 2018-02-06 Walk Vascular, Llc Systems and methods for removal of blood and thrombotic material
AU2021227924B2 (en) * 2020-02-27 2026-02-12 Boston Scientific Scimed, Inc. Medical treatment systems and related methods thereof
CN115443156A (zh) * 2020-02-28 2022-12-06 波士顿科学国际有限公司 多孔医疗设备及使用方法
WO2022140784A1 (fr) * 2020-12-22 2022-06-30 Nxt Biomedical, Llc Procédés et articles de drain chirurgical

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JP2025538213A (ja) 2025-11-26
WO2024102498A2 (fr) 2024-05-16
CN120379706A (zh) 2025-07-25
WO2024102498A3 (fr) 2024-07-18

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