Medical drains with mesh support porous internal axial drain support
Medical drains with a mesh support and porous internal axial drain effectively address the inadequacies of current treatments for postpartum hemorrhage by increasing fluid removal surface area and preventing clogging, leading to reduced hemorrhaging and improved safety.
Patent Information
- Application Number
- PCT/US2024/060864
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2023-12-18
- Filing Date
- 2024-12-18
- Publication Date
- 2025-06-26
AI Technical Summary
Current medical devices and surgical procedures for postpartum hemorrhage are inadequate in reducing blood loss and are often invasive, leading to the need for effective and safe treatments.
The development of medical drains with a mesh support and a porous internal axial drain, which include a cylindrical mesh drain that expands radially to increase surface area for fluid removal and prevent clogging, while a porous internal axial drain support constrains the drain within the suction lumen.
The medical drains effectively increase the surface area for fluid removal, prevent clogging, and reduce hemorrhaging by applying suction and causing the body cavity to contract, providing a safer and more effective treatment for postpartum hemorrhage.
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Abstract
Description
MEDICAL DRAINS WITH MESH SUPPORT POROUS INTERNAL AXIAL DRAINSUPPORTCLAIM OF PRIORITY
[0001] This patent application claims priority to U.S. provisional patent application no. 63 / 611,752, titled “MEDICAL DRAINS WITH MESH SUPPORT POROUS INTERNAL AXIAL DRAIN SUPPORT,” and filed on December 18, 2023, herein incorporated by reference in its entirety.INCORPORATION BY REFERENCE
[0002] All publications and patent applications mentioned in this specification are herein incorporated by reference in their entirety to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference.BACKGROUND
[0003] Postpartum hemorrhage, which is excessive uterine blood loss after birth, is the leading cause of maternal death in the world. The most common cause of postpartum hemorrhage is poor contraction of the uterus following childbirth. Normally after childbirth, the uterine muscles contract to cut off the blood flow to effectively pinch the arterial vessels that run through the tissue. Postpartum uterine bleeding can occur when the uterine muscles are unable to achieve adequate contraction after delivery to cut off the blood flow that formerly circulated in the utero-placental space, thereby leading to a steady loss of blood. The condition for this lack of contraction is referred to as uterine atony (lack of tone). The inability to control postpartum bleeding may require a woman to receive multiple blood transfusions, and in severe cases, a full hysterectomy.
[0004] Current medical devices and surgical procedures for postpartum hemorrhage have proven inadequate in reducing the amount of blood lost, and / or are extremely invasive (e.g., laparotomy or hysterectomy). Accordingly, there is a need for effective and safe treatments for controlling postpartum bleeding.SUMMARY OF THE DISCLOSURE
[0005] Described herein are apparatuses (e.g., devices and systems) and methods that are effective in removing fluid, gas and / or solid materials from a body region, such as a bodycavity. The apparatuses are well suited for the treatment of a postpartum uterus for prevention of postpartum hemorrhage, including after a caesarean section. The apparatuses may include a fluid removal member (e.g., a mesh member, in some variations a cylindrical mesh drain) that is extendable from an elongate member (e.g., tube) having a suction lumen extending therethrough. Suction may be applied to draw fluid (e.g., blood) and other bodily material into the suction lumen via the mesh member. The suction may also provide an inward pressure within the body cavity to cause walls of the body cavity to contract each other, e.g., compress against each other, thereby reducing hemorrhaging.
[0006] Devices for preventing postpartum hemorrhage, including surgical drain devices, for use in the uterus have had significant issues with blood clot material clogging the fluid (e.g., blood) intake portions of the device. Once the intake portions are clogged, the device may not provide sufficient vacuum in the uterus. The methods and apparatuses (e.g., devices, systems, etc., including surgical drains and / or postpartum drains) described herein may effectively increase the surface area from which fluid (e.g., blood) may be removed and may prevent or reduce clogging, even while operating in a region with a high concentration of clot material. In any of these methods and apparatuses, the fluid-removal portion (e.g., drain material) may be a cylindrical layer (or multiple layers, including an inverted layer) of porous material that may be deployed distally out of the suction lumen. The fluid-removal portion may be formed of one or more braided, woven or knit filaments that are highly porous. The fluid-removal portion (e.g., drain material) may be configured to self-expand to have a larger pore size in the deployed configuration, when extended distally out of the suction lumen. Alternatively or additionally, the cylindrical mesh drain may expand radially outwards when driven distally, e.g., by stacking up the mesh of the cylindrical mesh drain. The fluid-removal portion (e.g., drain material) may self-expand radially outwards as it is deployed distally out of the suction lumen. In any of these apparatuses and methods, the surface area of the fluidremoval portion (e.g., drain material), e.g. braid surface area, may be increased by increasing the outer diameter of drain material once deployed into the body, including into the uterus. In particular,. The methods and apparatuses described herein may include a porous internal axial drain support, that remains within the vacuum lumen and constrains the drain material in constricted configuration that support the drain material and prevents the drain material from engaging the inner diameter of the vacuum lumen, which may otherwise prevent the drain material from being deployed out of the vacuum lumen, e.g., by pushing the drain material distally.
[0007] The medical drains described herein may include a mesh conduit that is configured to radially compress the cylindrical mesh drain when the cylindrical mesh drain iswithin the elongate member. The conduit may provide axial support for the cylindrical mesh drain as the cylindrical mesh drain is extended distally through the elongate member. The conduit may eliminate or reduce friction between the cylindrical mesh drain and the internal surfaces of the elongate member. These features may allow for the use of a cylindrical mesh drain capable of expanding to have a larger porous surface area, which may increase the draining efficiency of the medical drain.
[0008] In general, any of the drain apparatuses described herein may be generically referred to as simply “drains.” Alternatively, these apparatuses may be referred to for convenience as “medical drains” or “surgical drains.” One particular, non-limiting, example of these apparatuses a surgical drain for preventing or reducing post-partum hemorrhage. These apparatuses (devices, systems, etc., including drains) are not limited to surgical use. With respect to use within the body, these apparatuses may be particularly useful for draining blood, e.g., postpartum, following a surgery or injury, etc., but may be used in other regions of the body, or for other uses, including the bladder (e.g., for removing urine, etc.), or the like.
[0009] For example, a medical drain may include a first elongate member comprising a suction lumen having a distal opening; a second elongate member that is slidably disposed in the suction lumen; a cylindrical mesh drain coupled to the second elongate member and having a constricted first configuration and an expanded second configuration, wherein the cylindrical mesh drain is biased to expand radially outward from the constricted first configuration to the expanded second configuration; and a porous internal axial drain support extending within the suction lumen, the porous internal axial drain support configured to hold the cylindrical mesh drain in the constricted first configuration within the suction lumen, wherein distal movement of the second elongate member causes the cylindrical mesh drain to extend distally out of the suction lumen so that the cylindrical mesh drain may expand radially out into the expanded second configuration, and wherein proximal movement of the second elongate member causes the cylindrical mesh drain to retract at least partially into the suction lumen so that the internal axial drain support collapses the cylindrical mesh drain into the constricted first configuration within the suction lumen, further wherein the cylindrical mesh drain and the porous internal axial drain support provides a plurality of flow paths for fluid to flow through and into the suction lumen when the cylindrical mesh drain is extended from the distal opening of the first elongate member and suction is applied through the suction lumen. The first elongate member may be a tubular member forming the suction lumen.
[0010] In some examples, a medical drain includes: a first elongate member having a lumen and a distal opening; a second elongate member that is slidably disposed in the lumen of the first elongate member; a cylindrical mesh drain that is coupled to the second elongate member; and a porous internal axial drain support coupled to the first and second elongate members and disposed within the lumen of first elongate member, the porous internal axial drain support defining an inner volume that is configured to house the cylindrical mesh drain, wherein distal movement of the second elongate member causes the cylindrical mesh drain to extend distally out of the porous internal axial drain support and the distal opening of the first elongate member, and proximal movement of the second elongate member causes the cylindrical mesh drain to retract at least partially within the porous internal axial drain support and the first elongate member, wherein the cylindrical mesh drain is configured to provide a plurality of flow paths for fluid to flow through when the cylindrical mesh drain is extended past the distal opening of the first elongate member and suction is applied through the first elongate member and / or the second elongate member.
[0011] Distal movement of the second elongate member may cause the porous internal axial drain support to axially compress as the cylindrical mesh drain extends distally out of the porous internal axial drain support and the distal opening of the first elongate member, and wherein the proximal movement of the second elongate member causes the porous internal axial drain support to axially expand as the cylindrical mesh drain retract at least partially within the porous internal axial drain support and the first elongate member. A wall of the porous internal axial drain support may include multiple openings that allow fluid to pass through the porous internal axial drain support. The porous internal axial drain support may have a helical shape. The porous internal axial drain support may include a spring. The porous internal axial drain support may include a tube with multiple openings that are configured to allow fluid to flow through walls of the porous internal axial drain support. The tube may include an outer surface with multiple standoff that are configured to maintain a radial position of the porous internal axial drain support with respect to the first elongate member. The porous internal axial drain support may be in the form of internal features of the first elongate member that are configured to decrease frictional resistance against the cylindrical mesh drain when the cylindrical mesh drain moves axially within the first elongate member. The porous internal axial drain support may be in the form of rods within the lumen of the first elongate member, wherein the rods are configured to decrease frictional resistance against the cylindrical mesh drain when the cylindrical mesh drain moves axially within the first elongate member. The porous internal axial drain support may be configured to provide a resistive force in a proximal direction as the cylindrical mesh drain is extendedout of the distal opening of the first elongate member. The resistive force ranges from about 5 to 200 grams per 2.5cm. The cylindrical mesh drain may be configured to radially expand as the cylindrical mesh drain is extended distally out of the distal opening of the first elongate member. The porous internal axial drain support may be configured to radially constrain the cylindrical mesh drain within the inner volume of the porous internal axial drain support. The porous internal axial drain support may be made of a metal material. The porous internal axial drain support may be made of a polymer material. The first elongate member may be made of a polymer material. The first elongate member may be made of a visibly transparent material such that the porous internal axial drain support is viewable through the first elongate member. The cylindrical mesh drain may have a tubular shape when expanded. The medical drain may further include a handle that is operationally coupled to the second elongate member. Pushing a knob of the handle may cause the distal movement of the second elongate member, and pulling the knob of the handle causes the proximal movement of the second elongate member. The handle may include a lock that is configured to lock axial movement of the second elongate member. The medical drain may further include an insertion tip coupled to a distal end of the first elongate member, the insertion tip having a rounded outer surface configured for atraumatic contact with body tissue. The insertion tip may be sized and shaped to create a seal with a non-dilated or minimally dilated cervix. The second elongate member may be a rod. The second elongate member may be a tube. When the cylindrical mesh drain is extended distally out of the porous internal axial drain support, the porous internal axial drain support may have an axially varied porosity where a distal portion of the porous internal axial drain support is more porous than a proximal portion of the porous internal axial drain support. The porous internal axial drain support may have a helical shape with a varied pitch.
[0012] Also described herein are methods of using any of these apparatuses. For example, a method of draining a body cavity (e.g., in some cases, a method of preventing or reducing post-partum bleeding) may include: inserting first elongate member of a medical drain in an orifice or body channel that leads to the body cavity, wherein a cylindrical mesh drain is supported within a suction lumen of the first elongate member by a porous internal axial drain support that prevents the cylindrical mesh drain from contacting a wall of the suction lumen; moving a second elongate member distally within the suction lumen, thereby causing the cylindrical mesh drain to extend distally at least partially out of the inner volume of the porous internal axial drain support and to expand radially outwards into the body cavity; and applying suction through the cylindrical mesh drain so that fluid passes through a plurality offlow paths of the cylindrical mesh drain and through the porous internal axial drain support into the suction lumen.
[0013] In some examples, a method of draining a body cavity includes: inserting first elongate member of a medical drain in an orifice or body channel that leads to the body cavity, wherein a porous internal axial drain support is disposed within a lumen of the first elongate member, and a cylindrical mesh drain is disposed within an inner volume of the porous internal axial drain support, wherein the medical drain includes a second elongate member that is slidably disposed in the lumen of the first elongate member and that is coupled to the porous internal axial drain support and the cylindrical mesh drain; moving the second elongate member distally within the first elongate member, thereby causing the cylindrical mesh drain to extend distally at least partially out of the inner volume of the porous internal axial drain support, the first elongate member, and into the body cavity; and applying suction through the cylindrical mesh drain so that fluid passes through a plurality of flow paths of the cylindrical mesh drain and through the first elongate member and / or the second elongate member. Moving the second elongate member distally within the first elongate member may cause the porous internal axial drain support to axially compress. The method may further include moving the second elongate member proximally within the first elongate member, thereby causing the cylindrical mesh drain to retract at least partially within the inner volume of the porous internal axial drain support. Moving the second elongate member proximally within the first elongate member may cause the porous internal axial drain support to axially expand. The method may further include, prior to applying the suction, creating a seal between the first elongate member and the orifice or the body channel. The seal may be created between a distal portion of the first elongate member and the orifice or the body channel. Applying the suction may cause fluid to pass through openings within a wall of the porous internal axial drain support. The porous internal axial drain support may include a spring that provides a resistive force in a proximal direction as the cylindrical mesh drain is extended distally at least partially out of the inner volume of the porous internal axial drain support, the first elongate member, and into the body cavity.
[0014] It should be appreciated that all combinations of the foregoing concepts and additional concepts discussed in greater detail below are contemplated as being part of the inventive subject matter disclosed herein and may be used to achieve the benefits described herein.
[0015] The process parameters and sequence of steps described and / or illustrated herein are given by way of example only and can be varied as desired. For example, while the steps illustrated and / or described herein may be shown or discussed in a particular order, thesesteps do not necessarily need to be performed in the order illustrated or discussed. The various example methods described and / or illustrated herein may also omit one or more of the steps described or illustrated herein or include additional steps in addition to those disclosed.
[0016] All of the methods and apparatuses described herein, in any combination, are herein contemplated and can be used to achieve the benefits as described herein.BRIEF DESCRIPTION OF THE DRAWINGS
[0017] A better understanding of the features and advantages of the methods and apparatuses described herein will be obtained by reference to the following detailed description that sets forth illustrative embodiments.
[0018] FIGS. 1 A-1D illustrates an example use of a negative pressure medical drain in a soft tissue region of a body: FIG. 1 A shows a first cross sectional view of the soft tissue region; FIG. IB shows a second cross sectional view of the soft tissue region; FIG. 1C shows the medical drain after a cylindrical mesh drain is inserted within the body region and as a negative pressure is applied; and FIG. ID shows the cylindrical mesh drain in the body region after the body region is at least partially contracted.
[0019] FIGS. 2 A and 2B illustrate side section views of an example medical drain with an extendable shaped tip: FIG. 2 A shows the drain in a retracted configuration; and FIG. 2B shows the drain in an extended (e.g., deployed) configuration.
[0020] FIGS. 3A and 3B illustrate side section views of an example medical drain that has a cylindrical mesh drain with a larger diameter than that of the medical drain of FIGS. 2 A and 3B: FIG. 3 A shows the drain in a retracted configuration; and FIG. 3B shows a closeup view of a portion of the drain.
[0021] FIGS. 4A-4H illustrate side section views an example medical drain with a mesh porous internal axial drain support that is configured to support and guide the cylindrical mesh drain during deployment and / or retraction: FIG. 4A shows the drain in a retracted configuration; FIG. 4B shows a closeup view of the insertion tip with retracted cylindrical mesh drain; FIG. 4C shows another view of the drain in the deployed configuration; FIG. 4D shows a closeup view of the porous internal axial drain support when the drain is in the deployed configuration; FIG. 4E shows fluid flow paths through the drain; FIG. 4F shows fluid flow paths through the porous internal axial drain support of the drain; FIG. 4G shows a closeup view of the porous internal axial drain support when the drain is in the retracted / loaded configuration; and FIG. 4H shows a closeup view of the porous internal axial drain support when the drain is in the deployed / unloaded configuration.
[0022] FIGS. 5A-5D illustrate side section views of another example medical drain, which includes an axially varied porosity distribution: FIG. 5A shows the drain in a deployed configuration; FIG. 5B shows a closeup view of the porous internal axial drain support when the drain is in the deployed configuration; FIG. 5C shows the drain in a retracted configuration; and FIG. 5D shows a closeup view of the porous internal axial drain support when the drain is in the retracted configuration.
[0023] FIGS. 6A-6E illustrate views of an example medical drain having a tubular mesh porous internal axial drain support: FIG. 6A shows the drain in a retracted / loaded configuration; FIG. 6B shows a closeup view showing details of the porous internal axial drain support; FIG. 6C shows a side view of the porous internal axial drain support; FIG. 6D shows one perspective view of the porous internal axial drain support; and FIG. 6E shows another perspective view of the porous internal axial drain support.
[0024] FIGS. 7A-7D illustrate views of an example medical drain with a mesh porous internal axial drain support that is in the form of internal features of the first elongate member: FIG. 7A shows the drain in a retracted / loaded configuration; FIG. 7B shows a partially transparent front view of the drain; FIG. 7C show a partially transparent perspective view of a portion of the first elongate member; and FIG. 7D shows a front perspective view of the first elongate member.
[0025] FIGS. 8A-8C illustrate views of an example medical drain with a mesh porous internal axial drain support that is in the form of rods within the first elongate member: FIG. 8A shows the drain in a retracted / loaded configuration; FIG. 8B shows a partially transparent section view of the rods and first elongate member; and FIG. 8C shows a partially transparent closeup view of the rods.
[0026] FIGS. 9A-9E illustrate side views of an example medical drain with a helical spring-type porous internal axial drain support: FIG. 9A shows the drain in a retracted / loaded configuration; FIG. 9B shows the drain in a deployed configuration; FIG. 9C shows a closeup view of the cylindrical mesh drain in an expanded and deployed configuration; FIG. 9D shows a closeup view of the porous internal axial drain support when the cylindrical mesh drain in the expanded and deployed configuration; and FIG. 9E shows a closeup view of the porous internal axial drain support and cylindrical mesh drain when the cylindrical mesh drain is retracted within the porous internal axial drain support.
[0027] FIG. 10 is a flowchart illustrating an example method of treating a body region using a medical drain.DETAILED DESCRIPTION
[0028] The apparatuses (e.g., devices, systems, etc.) and methods described herein relate to drains (e.g., medical drains) for removing fluid (e.g., blood, lymph, pus, etc.) and / or other material from a wound or body cavity. The drains include negative pressure drains that can generate and sustain negative pressure within soft tissue or a body cavity. The drains include a compliant cylindrical mesh drain material that is extendable from an elongate member (e.g., tube or catheter). When extended from the elongate member, the cylindrical mesh drain provides flow paths for fluid to flow through when suction is applied. A porous internal axial drain support within the elongate member can support the cylindrical mesh drain in a compressed state when inside the elongate body and provide a means for releasing the cylindrical mesh drain from the elongate member.
[0029] The cylindrical mesh drain may include a plurality and / or a network of pores (e.g., open cell structure) that is configured to draw fluid, air and / or solid materials from a body cavity. In some examples, the cylindrical mesh drain includes a braided material. During use, the cylindrical mesh drain may be extended from the elongate member and positioned within a wound or body cavity (e.g., postpartum uterus) where suction may be applied via the elongate member to drain fluid (e.g., blood, lymph, pus, etc.) from the wound or body cavity. In some cases, the cylindrical mesh drain is tubular in shape when expanded and extended out of the elongate member. In other cases, the cylindrical mesh drain has a non-tubular shape (e.g., cylindrical shape, flat sheet, etc.). The negative pressure may also cause the body cavity (e.g., postpartum uterus) to contract, thereby reducing hemorrhaging. Examples of negative pressure medical drains are described in U.S. Patent Application Publication No. 2023 / 0241303, which is incorporated by reference herein in its entirety.
[0030] The porous internal axial drain support can define an inner volume that is sized and shaped to house the cylindrical mesh drain. The porous internal axial drain support may radially compress the cylindrical mesh drain in a compressed state when within the elongate member. The cylindrical mesh drain may expand when released from the porous internal axial drain support and the elongate member, thereby providing more surface area (e.g., pores) for fluid removal.
[0031] In some cases, the porous internal axial drain support may be axially compressible and extendable within the elongate body. For example, a second elongate member (e.g., rod or tube) may be coupled with the porous internal axial drain support. Distal movement of the second elongate member can cause the porous internal axial drain support to axially compress and the cylindrical mesh drain to extend distally out of the distal opening of the first elongate member, and proximal movement of the second elongate member causes the porous internalaxial drain support to axially expand and the cylindrical mesh drain to retract at least partially within the first elongate member.
[0032] The apparatuses and methods described herein may be used to treat postpartum hemorrhage for situations of a vaginal delivery or a caesarean section. The size of the portions of the apparatus may vary depending on whether the delivery is a vaginal birth or caesarean section. For example, an apparatus that is designed for insertion into a post-vaginal birth cervix may be larger than that used in non-dilated or minimally dilated cervix. The larger size (e.g., diameter) used in the post-vaginal birth cervix may allow for proper sealing with the walls of the cervix. Alternatively or additionally, apparatuses used in vaginal delivery and a caesarean section may include different features. For example, an apparatus used in a post-vaginal birth cervix may include an expandable plug that allows for the proper sealing. In some cases, an apparatus used in a non-dilated or minimally dilated cervix may also include an expandable plug.
[0033] FIGS. 1 A-1D show an example of a medical drain used in a soft tissue region of a body. FIG. 1 A shows a first cross sectional view of the soft tissue region, which includes a cavity 120 and a channel 122 that leads to the cavity 120. In some cases, the soft tissue region may be a surgical site or a site of removal for tumor. In other cases, the cavity 120 may be a postpartum uterus, and the channel 122 may include a portion of the vaginal canal 123 and the cervix 124. The cervix 124 may be non-dilated or minimally dilated, for example, in the case of a caesarean section. In other cases, the cervix 124 may a dilated, for example, after a vagina birth.
[0034] FIG. IB shows a second sectional view (e.g., taken at 90 degrees offset from the view shown in FIG. 1 A). As shown, in some cases, the cavity 120 may be open more in one direction than another.
[0035] FIG. 1C shows a medical drain after being inserted within channel 122 and into the body cavity 120. The medical drain includes a first elongate member 110, a cylindrical mesh drain 108 and a second elongate member 112. In some examples, the medical drain optionally includes an insertion tip 125a / b, which may have a tapered shape to facilitate insertion into the channel 122. In this case, the insertion tip includes a proximal portion 125a that is separable from a distal portion 125b. In the case of a postpartum uterus, the insertion tip 125a / b can be positioned within the cervix and create a seal with the walls of the cervix. In the case of a non-dilated or minimally dilated cervix, which is smaller than a dilated cervix, the first elongate member 110 and / or the proximal portion of the insertion tip 125a can be sized to form a seal with walls of the non-dilated or minimally dilated cervix.
[0036] The cylindrical mesh drain 108 is extended distally out of the first elongate member 110, (e.g., through an opening of the proximal portion of the insertion tip 125a) and into the body cavity 120. In some examples, this involves pushing the second elongate member 112, which is coupled with the cylindrical mesh drain 108, through the first elongate member 110. In other examples, the second elongate member 112 is not used or present, and the cylindrical mesh drain 108 may be pushed directly through the first elongate member 110.
[0037] Once the cylindrical mesh drain 108 is deployed within the cavity 120, a negative pressure may be applied through the lumen of the first elongate member 110 and / or the second elongate member 112 to cause fluid, gas and / or other bodily material from the cavity 120 to flow proximally through the cylindrical mesh drain 108, into the first elongate member 110 and / or the second elongate member 112, and eventually out of the cavity 120. For example, the proximal end of the first elongate member 110 and / or the second elongate member 112 may be operationally coupled to a vacuum source for applying a vacuum through the lumen of the first elongate member 110 and / or the second elongate member 112 and the cylindrical mesh drain 108.
[0038] The cylindrical mesh drain 108 may have a porous structure (e.g., open pore structure) that creates multiple flow paths for the fluid, gas and / or solid material to pass through the cylindrical mesh drain 108 and into the first elongate member 110. In some examples, the first elongate member 110 may include one or more openings at the distal end and / or side walls of the first elongate member 110 for the fluid, etc. to flow through.
[0039] The first elongate member 110 may be any appropriate length so that it may be manipulated and position the cylindrical mesh drain 108 within the body region being treated. For example, the first elongate member 110 may be between 5 cm and 100 cm long (e.g., between 10 cm and 50 cm, between 10 cm and 35 cm, between 10 and 30 cm, etc.). The first elongate member 110 may be straight (as shown) or curved, including curved with a fixed curve (e.g., between 10-80 degrees). In some cases, the first elongate member 110 and / or second elongate member 112 may be laterally flexible.
[0040] In some cases, the second elongate member 112 (if present) may be coupled to the cylindrical mesh drain 108 and be configured to be axially movable within the lumen of the first elongate member 110. The cylindrical mesh drain 108 may be radially compressible such that the outer diameter of the cylindrical mesh drain 108 can be compressed for entry into the first elongate member 110. In some cases, the cylindrical mesh drain 108 may have a sufficient column stiffness and bending stiffness to provide adequate flow through a cross section of the cylindrical mesh drain 108.
[0041] In some examples the cylindrical mesh drain 108 may be compressed into a compressed state within the first elongate member 110. Once released from the first elongate member 110 and extended within the cavity 120, the cylindrical mesh drain 108 may expand into an expanded state. In some cases, the cylindrical mesh drain 108 may be configured to take on a pre-determined shape (e.g., bent shape), for example, to conform to a shape of a particular body cavity.
[0042] In some examples, the first elongate member 110 and / or the second elongate member 112 may include one or more stops that limit their relative axial movement. For example, the first elongate member 110 and the second elongate member 112 may be configured to lock with respect to each other when the cylindrical mesh drain 108 is extended distally. In some examples, the drain includes one or more locks configured to releasably lock the relative axial positions of the first elongate member 110 and the second elongate member 112.
[0043] The negative pressure can be maintained within the cavity 120 since a seal is formed between the first elongate body 110 and / or the proximal portion of the insertion tip 125a and the walls of the channel 122 (e.g., cervix 124). The negative pressure may create an inward force on the surrounding walls of the cavity 120 (indicated by inward facing arrows in FIG. 1C), thereby causing the body cavity 120 (e.g., uterus) to at least partially contract, as shown in FIG. ID. Such contraction may be beneficial, for example, in cases where contracting a postpartum uterus may reduce hemorrhaging. The cylindrical mesh drain 108 can maintain a shape that provides efficient flow of fluid, gas and / or other bodily material through the network of pores of the cylindrical mesh drain 108, even when compressed by the tissue, as shown in FIG. ID.
[0044] The negative pressure may be maintained for a period of time to provide a therapeutic benefit. For example, the negative pressure may be applied until the cavity 120 is sufficiently drained of fluid and / or the cavity 120 is sufficiently contracted. In some examples, the period of time may range from one minute to several hours or even days. For example, the period of time may range from one minute to 5 days or more (e.g., 10 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, or 10 hours, 12 hours, 18 hours, 24 hours, 48 hours, 3 days, 4 days, 5 days, etc.). For example, when treating postpartum bleeding, these apparatuses may maintain pressure for 0.5 to 10 hours (e.g., 0.5 to 9 hours, 0.5 to 8 hours, etc.); for treating breast reconstruction, bladder, chest tube, lung drainage, etc. these periods may be even longer.
[0045] After treatment is complete, the cylindrical mesh drain 108 may be removed from the cavity 120 by proximally moving the cylindrical mesh drain 108 out of the cavity 120.For example, the second elongate member 112 (if present) may be pulled proximally to retract the cylindrical mesh drain 108 within the first elongate member 110. The entire device can be pulled out of the cavity 120 and channel 122. In other examples (e.g., where the second elongate member 112 is not used), the first elongate member 110 may be pulled to directly pull the cylindrical mesh drain 108 and the entire device out of the cavity 120.
[0046] FIGS. 2A and 2B illustrate an example of a medical drain 200. The medical drain 200 includes a first elongate member 210 and a second elongate member 212 that is configured to slide within a lumen of the first elongate member 210. The medical drain 200 may be in the retracted configuration (FIG. 2A) during insertion into a body orifice, channel, or canal. A user may hold a second (e.g., distal) portion 218 of a handle 214 and push the first elongate member 210 with a tubular shaped cylindrical mesh drain 208 positioned within the lumen of the first elongate member 210. In this example, the medical drain 200 includes a tapered insertion tip 225 that facilitates entry of the first elongate member 210 into the body orifice, channel, or canal. For example, the tapered shape of the insertion tip 225 may make it easier to insert the device into a smaller body orifice, such as an external orifice of a nondilated or minimally dilated cervix. Once the tip 225 is positioned within the body orifice, channel, or canal (e.g., cervix), a first (e.g., proximal) portion 216 of the handle 214 may be advanced distally toward the second (e.g., distal) portion 218 of the handle 214, which causes the second elongate member 212 to slide distally within the first elongate member 210 and to extend the cylindrical mesh drain 208 out of the first elongate member 210 (FIG. 2B) and into a body cavity (e.g., uterus).
[0047] In the example device 200 of FIGS. 2A and 2B, the insertion tip 225 has a first (e.g., proximal) portion 225a and a second (e.g., distal) portion 225b. The first (e.g., proximal) portion 225a is coupled with the first elongate member 210, and the second (e.g., distal) portion 225b is coupled with the cylindrical mesh drain 208. When the cylindrical mesh drain 208 is extended out of a distal opening of the first elongate member 210 (e.g., distal opening of the first (e.g., proximal) portion 225a), the second (e.g., distal) portion 225b of the insertion tip 225 extends distally along with the cylindrical mesh drain 225b away from the first (e.g., proximal) portion 225a.
[0048] The first elongate member 210 and / or the first (e.g., proximal) portion 225a of the insertion tip 225 may form a seal with the body orifice, channel, or canal (e.g., cervix). Suction may be applied through the first elongate member 210 via an inlet / outlet 232 (e.g., fitting) connected to a vacuum source. In some examples, the second elongate member 212 may be a tube through with suction may be applied (e.g., in additional to or instead of the first elongate member 210).
[0049] In the example device 200 of FIGS. 2A and 2B, the cylindrical mesh drain 208 has a relatively small diameter. For example, the cylindrical mesh drain 208 may have a diameter that is not greater than the inner diameter of the distal portion of the first (e.g., proximal) portion 225a of the insertion tip 225. However, the relatively small diameter cylindrical mesh drain 208 may limit the available porous surface area of the cylindrical mesh drain 208 for removing fluid from the body cavity. The smaller porous surface area may mean that the cylindrical mesh drain 208 is more likely to become clogged by solid or semisolid materials (e.g., blood clots) compared to a mesh having a larger porous surface area.
[0050] FIGS. 3A and 3B shows an example device 300 that has cylindrical mesh drain 308 with a larger outer diameter than that of the cylindrical mesh drain 208 in FIGS. 2A and 2B. The larger diameter cylindrical mesh drain 308 provides a greater porous surface area when the cylindrical mesh drain 308 is extended out of the first elongate member 310, thereby reducing the occurrence of clogging and providing more efficient fluid removal. However, the cylindrical mesh drain 308 may not have a sufficiently high column strength to resist buckling when an axial force is applied (e.g., when a pushing force is applied to the second elongate member 312). Such buckling can cause the cylindrical mesh drain 308 to cleat on the inner surface of the first elongate member 301, thereby making it difficult to extend the cylindrical mesh drain 308 from the first elongate member 310.
[0051] The devices described herein include features to address the problems described above. The devices include a cylindrical mesh drain that has a relatively large porous surface area for efficient fluid draining. The devices include a porous internal axial drain support that is configured to allow for axial movement of the cylindrical mesh drain within the first elongate member (e.g., tube), thereby allowing the cylindrical mesh drain to be extended out of the first elongate member upon user activation. The porous internal axial drain support may provide axial support for the cylindrical mesh drain within the first elongate member so that the cylindrical mesh drain can be extended out of the first elongate member, for example, when the user pushes a second elongate member.
[0052] FIGS. 4A-4H show an example medical drain 400 according to some examples. FIG. 4A shows the device 400 in a loaded configuration where a cylindrical mesh drain 408 is disposed within a lumen of a first elongate member 410. The cylindrical mesh drain 408 is disposed within an inner volume defined by a porous internal axial drain support 430, which is disposed within the lumen the first elongate member 410. In this example, the cylindrical mesh drain 408 has tubular shape. The porous internal axial drain support 430 maintains the cylindrical mesh drain 408 in a radially compressed state while the cylindrical mesh drain 408 is in the first elongate member 410. A proximal portion of the porous internal axial drainsupport 430 is coupled with a second elongate member 412, and a distal portion of the porous internal axial drain support 430 is coupled with the first elongate member 410. In this example, the proximal portion of the porous internal axial drain support 430 and the cylindrical mesh drain 408 are coupled with the second elongate member 412 via a coupler (e.g., fastener, tape, crimp or another type of coupler) 409. In this example, the distal portion of the porous internal axial drain support 430 is coupled with the first elongate member 410 via a proximal portion 425a of an insertion tip 425.
[0053] FIG. 4B shows the device 400 in a deployed configuration where the cylindrical mesh drain 408 is at least partially extended distally out of a distal opening of the first elongate member 410 (e.g., a distal opening of the proximal portion 425a of the insertion tip 425). When deployed, the cylindrical mesh drain 408 radially expands to a diameter that is larger than the distal opening of the first elongate member 410 (e.g., distal opening of the proximal portion 425a of the insertion tip 425). Being able to expand to a larger diameter provides a greater porous surface area to the cylindrical mesh drain 408, thus reducing the occurrence of clogging and improving the fluid draining efficiency of the device 400 (e.g., compared to the device of 200).
[0054] In the example of drain 400, the proximal portion 425a of the insertion tip 425 may have a shape and size for sealing with the inner walls of the cervix. The proximal portion 425a of the insertion tip 425 may have a rounded outer surface for atraumatic tissue contact. The outer diameter of the proximal portion 425a of the insertion tip 425 may vary depending on whether the cervix is dilated, non-dilated or minimally dilated. In some examples, the drain 400 may include a larger proximal portion 425a for a dilated cervix (e.g., after vaginal birth) and / or may include a cervical plug that is made of a compressible and expandable material (e.g., foam or sponge-like material), such as described in U.S. Patent Application Publication No. 2023 / 0241303, which is incorporated by reference herein in its entirety.
[0055] The diameters of the proximal portion 425a of the insertion tip 425 and / or the first elongate member 410 may be smaller in examples that are used in a non-dilated or minimally dilated cervix (e.g., after caesarean section) compared to examples that are used in dilated cervix (e.g., after vaginal birth). For example, the diameter of the proximal portion 425a of the insertion tip 425 and the first elongate member 210 may be small enough to fit within an orifice (e.g., non-dilated or minimally dilated cervix) having a 2 centimeter (cm) diameter or less. In some examples, the diameter of the first elongate member 410 may range from 3 French scale (Fr) to 10 Fr (e.g., between 3F and 9 F, between 3F and 8F, between 4F and 7F, between 3F and 6F, etc.). In some examples some or all of the insertion tip 425 is tapered and / or rounded to provide atraumatic entry into the cervix. The proximal portion 425a of theinsertion tip 425 may have a larger diameter than the first elongate member 410 so that the proximal portion 425a can create a seal with the walls of a non-dilated or minimally dilated cervix. In some examples, the outer diameter of the widest part of the proximal portion 425a may range between 60 Fr and 110 Fr (e.g., between 70F- 115F, between 80F-110 F, between 85F and 100F, between 85F and 95F, etc.).
[0056] To deploy the cylindrical mesh drain 408, a user advances (e.g., pushes) a first (e.g., proximal) portion 416 (e.g., knob) of a handle distally toward a second (e.g., distal) portion 418 of the handle, which causes the second elongate member 412 to slide distally within the first elongate member 410 and to extend the cylindrical mesh drain 408 out of the first elongate member 410. The porous internal axial drain support 430 axially compresses as the second elongate member 412 and the cylindrical mesh drain 408 are advanced distally. The porous internal axial drain support 430 supports and provides axial rigidity to the cylindrical mesh drain 408 while the cylindrical mesh drain 408 is within the porous internal axial drain support 430 so that the cylindrical mesh drain 408 can be pushed through the porous internal axial drain support 430 without the cylindrical mesh drain 408 axially collapsing. In addition, the walls of the porous internal axial drain support 430 may eliminate or reduce friction between the cylindrical mesh drain 408 and the inner walls of the first elongate member 410. For example, without the porous internal axial drain support 430, the cylindrical mesh drain 408 may rub against the inner surface of the first elongate member 410, and the radially outward force of the cylindrical mesh drain 408 may cause the cylindrical mesh drain 408 to cleat against the inner surface of the first elongate member 410 such that the cylindrical mesh drain 408 would not move distally when force is applied to proximal knob 416.
[0057] To retract the cylindrical mesh drain 408 back into the first elongate member 410 (e.g., after draining fluid from a body cavity), the user pulls back the first (e.g., proximal) portion 416 of the handle proximally away from the second (e.g., distal) portion 418 of the handle, which causes the second elongate member 412 to slide proximally within the first elongate member 410 and pull the cylindrical mesh drain 408 into the porous internal axial drain support 430. The porous internal axial drain support 430 axially expands as the cylindrical mesh drain 408 is pulled within the inner volume of the porous internal axial drain support 430.
[0058] FIGS. 4C and 4D show cross sections views of the device 400 in a deployed configuration. As shown in the closeup view of FIG. 4D, the porous internal axial drain support 430 has a helical shape with the pitch of the helix defining multiple openings 435 between the turns of the helix. A first (e.g., proximal) end of the porous internal axial drainsupport 430 is coupled with a second elongate member 412, and a second (e.g., distal) end of the porous internal axial drain support 430 is coupled with the first elongate member 410 via the proximal portion 425a of the insertion tip. In other examples, the porous internal axial drain support 430 may be in a different form, such as a slatted tube, a series of washers, a telescoping tube, or other shape.
[0059] In some examples, the porous internal axial drain support 430 is a spring that is configured to provide a spring force. For example, the porous internal axial drain support 430 may be configured to store energy when in the compressed state (e.g., when the cylindrical mesh drain 408 is extended from the first elongate member 410) and release the stored energy when transitioning to an expanded state (e.g., when the cylindrical mesh drain 408 is retracted into the porous internal axial drain support 430). The spring force may provide some resistance against the user pushing the knob 416 of the handle. In some examples, such resistive force may be beneficial in that it can provide a more controlled extension of the cylindrical mesh drain 408 and a better “feel” for the user when deploying the cylindrical mesh drain 408. The spring force may also provide an axial force in proximal direction when the cylindrical mesh drain 408 is retracted, thereby making it easier for the user to pull the cylindrical mesh drain 408 back into the first elongate member 410 (e.g., distal opening of the proximal portion 425a of the insertion tip 425). However, the porous internal axial drain support 430 may be configured to provide a spring force within a predetermined upper limit. For example, too high of a spring force may allow for uncontrolled axial movement of the porous internal axial drain support 430 and cylindrical mesh drain 408. In some examples, the porous internal axial drain support 430 is configured to provide a spring force ranging between about 5 to about 200 grams / 2.5cm In some example, the porous internal axial drain support is configured a coli or spring having a wire size of between about 0.01” to 0.03”, e.g., about 0.015”. In some examples the porous internal axial drain support is formed of a stainless steel or nickel titanium (e.g., Nitinol) material. The diameter / conduit ID of the porous internal axial drain support may be, e.g., between about 0.15” to3A", e.g., about 0.375”, and in some cases may have a pitch range of between about 2-15 turns per inch (e.g., about 5 turns per inch).
[0060] The device 400 may include a lock to lock the axial position of the second elongate member 412 with respect to the first elongate member 410. The lock may include a first portion 450 at the first (e.g., proximal) portion 416 (e.g., knob) of the handle, and a second portion 451 at the second (e.g., distal) portion 418 of the handle. The first and second portions 450 / 451 of the lock are configured to engage and lock the axial position of the second elongate member 412 with respect to the first elongate member 410. For example, thesecond portion 451 of the lock may include a protrusion or indentation (e.g., ring-shaped protrusion or indentation) that is configured to engage with a corresponding protrusion or indentation (e.g., ring-shaped protrusion or indentation) of the first portion 450 of the lock. In some examples, one or both of the first and second portions 450 / 451 includes a grommet or washer. In cases where the porous internal axial drain support applies a spring force, the lock 450 / 451 may prevent the spring force from expanding the porous internal axial drain support 430 when in the axially compressed state, thereby maintaining the cylindrical mesh drain 408 in the extended and expanded state.
[0061] The porous internal axial drain support 430 may also be configured to provide flow paths for fluid to flow through, as illustrated in FIGS. 4E and 4F. When the cylindrical mesh drain 408 is expanded within the body cavity and a seal a created, suction may be applied to the lumen of the first elongate member 410 via inlet / outlet 432. The suction causes fluid and other bodily material to flow within the pores and into the inner portion of the tubular cylindrical mesh drain 408, into the lumen of the first elongate member 410 and out of the device 400 via the inlet / outlet 432. As shown in the closeup section view of FIG. 4F, the fluid path includes the multiple openings 435 of the porous internal axial drain support 430. This porous characteristic of the porous internal axial drain support 430 reduces the occurrence of clogging and provided more efficient fluid flow compared to a non-porous internal axial drain support 430.
[0062] FIGS. 4G and 4H show closeup views of the porous internal axial drain support 430 and cylindrical mesh drain 408. FIG. 4G shows a closeup of a portion of the porous internal axial drain support 430 and cylindrical mesh drain 408 when the cylindrical mesh drain 408 is radially collapsed and retracted within the porous internal axial drain support 430, and the porous internal axial drain support 430 is in an axially expanded configuration. FIG. 4H shows the cylindrical mesh drain 408 deployed out of the first elongate member 410 and the proximal portion proximal portion 425a of the insertion tip. When deployed the cylindrical mesh drain 408 is a radially expanded state, and the porous internal axial drain support 430 in an axially collapsed configuration.
[0063] When the device is in the undeployed / loaded state (e.g., FIG. 4G), the cylindrical mesh drain 408 is maintained in the collapsed state by force from the inner surfaces of the porous internal axial drain support 430. The diameter of the cylindrical mesh drain 408 is reduced compared to the diameter of the cylindrical mesh drain 408 when not confined within the porous internal axial drain support 430. Radially compressing the cylindrical mesh drain 408 increases its column strength, making it less likely to buckle when pushed distally out of the first elongate member 410. In addition, the walls of the porous internal axial drain support430 may be between at least part of the cylindrical mesh drain 408 and the inner walls 437 of the first elongate member 410, thereby reducing or eliminating friction between the cylindrical mesh drain 408 and the inner walls 437 of the first elongate member 410 as the cylindrical mesh drain 408 moves axially through the first elongate member 410. The fibers (e.g., yarns) 436 of the cylindrical mesh drain 408 may slide against the inner surfaces of porous internal axial drain support 430 as the cylindrical mesh drain 408 moves out of the porous internal axial drain support 430. In some cases, the fibers 436 of the cylindrical mesh drain 408 may be oriented in a direction in accordance with the applied load, making the cylindrical mesh drain 408 better at transferring the load. For example, when the braid mesh is inside the spring, it may become elongated, and the individual filaments may be arranged on the long axis. When braids are compressed inside a small tube (e.g., within an internal axial drain support (e.g., a spring), the braid may become long, and the filaments may run almost parallel to the long axis. Once outside the internal axial drain support, the braid may expand, shorten, and the filaments may behave like a trellis. The constrained braid inside the spring may have sufficient column force so that it can be pushed out of the device. The internal axial drain support may keep the braid column so it can be pushed.
[0064] FIGS. 5A-5D show another example of a medical drain 500 that is similar to the drain 400 of FIGS. 4A-4H, except that the drain 500 includes a porous internal axial drain support 530 with an axially varied porosity distribution. In the example of device 500, the porous internal axial drain support 530 has a helical shape that is configured to have a varied pitch, thereby providing axially varied permeability for fluid to flow through the porous internal axial drain support 530.
[0065] FIGS. 5A and 5B show the device 500 in a deployed configuration, where the cylindrical mesh drain 508 is extended and expanded out of the first elongate member 510. The porous internal axial drain support 530 is configured to axially contract as the cylindrical mesh drain 508 is deployed until a first (e.g., proximal) portion 516 (e.g., knob) of a handle reaches a stop of a second (e.g., distal) portion 518 of the handle. In some examples, the handle includes a lock 550 / 551 that locks the axial movement of the second elongate member 512 in the deployed configuration, as described above. When the second portion 518 of the handle reaches the first portion 516 of the handle, the cylindrical mesh drain 508 may be considered fully deployed from the first elongate member 510. In the cylindrical mesh drain is deployed, the porous internal axial drain support 530 takes on an axially compressed configuration where spaces between turns of a distal portion 530a of the porous internal axial drain support 530 are larger than spaces between turns of a proximal portion 530b of the porous internal axial drain support 530. Thus, the distal portion 530a of the porous internalaxial drain support 530 has a greater porosity than the proximal portion 530b of the porous internal axial drain support 530. The greater porosity of the distal portion 530a allows fluid to flow through the distal portion 530a, thereby increasing the fluid removal efficiency of the device 500.
[0066] FIGS. 5C and 5D show the device 500 in a retracted / loaded configuration where the cylindrical mesh drain 508 is retracted within the first elongate member 530. The porous internal axial drain support 530 axially expands and the cylindrical mesh drain 508 slides within the porous internal axial drain support 530 as the cylindrical mesh drain 508 retracts into the first elongate member 310.
[0067] FIGS. 6A-6E show another example of a medical drain 600 that is similar to the drains 400 and 500, except that the medical drain 600 includes a different type of porous internal axial drain support 630. In the example of device 600, the porous internal axial drain support 630 has a cylindrical (e.g., tubular) shape with openings 660 distributed axially and radially around the porous internal axial drain support 630. The openings 660 may allow fluid to flow through the walls of the porous internal axial drain support 630 to provide efficient fluid removal. In addition, the porous internal axial drain support 630 includes standoffs 662 that are distributed axially and radially along an outer surface of the porous internal axial drain support 630. The standoffs 662 may be configured to engage with the inner surface 637 of the first elongate member 610 to maintain the radial position of the porous internal axial drain support 630 with respect to the lumen of the first elongate member 610. For example, the standoffs 662 may be configured to hold the porous internal axial drain support 630 in a concentrically aligned position with respect to the first elongate member 610. The standoffs 662 may center the support structure in the center of the tube 610. Centering may improve deployment and reduce chance to effect fluid flow when suction is on.
[0068] As in the devices 400 and 500, the porous internal axial drain support 630 is configured to support and restrain the cylindrical mesh drain 608 in a radially collapsed state when the device 600 is in an undeployed / loaded configuration. However, unlike in devices 400 and 500, the porous internal axial drain support 630 is not axially collapsible.
[0069] FIG. 6E shows how the cylindrically shaped porous internal axial drain support 630 forms a lumen 669. The lumen 669 is shaped and sized to hold the cylindrical mesh drain 608 when the cylindrical mesh drain 608 is the retracted configuration. When the cylindrical mesh drain 608 is extended at least partially out of the lumen 669, the lumen 669 can act as a fluid channel from fluid flow from the openings 660.
[0070] FIGS. 7A-7D show another example of a medical drain 700. In device 700, the porous internal axial drain support for the cylindrical mesh drain 708 is in the form of internalfeatures of the first elongate member 710 that form a particular internal profile 730. The internal profile 730 is shaped to provide axial support for and less frictional resistance against the cylindrical mesh drain 708 as the cylindrical mesh drain 708 is pushed distally out of the distal end of the elongate member 710. In this example, the internal profile 730 defines multiple internal projections 745 that project into the lumen of first elongate member 710. The internal projections 745 define a central space 749, which runs axially parallel to the longitudinal axis of the first elongate member 710. The cylindrical mesh drain 708 may reside within the central space 749 when retracted within the first elongate member 710. When a pushing force is applied to the second elongate member 712, the cylindrical mesh drain 708 slides against the internal projections 745 and distally out of the first elongate member 710. The internal projections 745 may allow for less contact area between the cylindrical mesh drain 708 and the first elongate member 710 compared to an elongate member having a circular profile. Thus, there may be less frictional resistance placed on the cylindrical mesh drain 708 during deployment compared to an elongate member having a circular profile. In this example, the first elongate member 710 includes four internal projections 745. However, the first elongate may include any number of internal projections (e.g., 1, 2, 3, 4, 5, 6, 7, 8, etc.).
[0071] In the example shown in FIGS. 7A-7D, the profile of the tube’s inner surface may maintain fluid flow when suction is being applied. Small projections may support sliding braid and not block flow of fluid (e.g., blood, for instance). Thus, the internal axial drain support may provide a low contact surface between the suction lumen and the cylindrical mesh drain, such less than 20% (e.g., 20% or less, 19% or less, 18% or less, 17% or less, 16% or less, 15% or less, 14% or less, 13% or less, 12% or less, 11% or less, 10% or less, 9% or less, 8% or less, 7% or less, 6% or less, 5% or less, etc.) contact between the mesh drain ad the wall(s) of the suction lumen. In general, the internal axial drain support may prevent the cylindrical mesh drain from expanding to contact the inner diameter (e.g., maximum inner diameter) of the suction lumen.
[0072] FIGS. 8A-8C show another example of a medical drain 800 that is similar to the drain 700, except that the porous internal axial drain support is in the form of rods 840 within the inner lumen of the first elongate member 810. The rods 840 may be coupled to the interior surface of the first elongate member 810 or may be integrally formed with the first elongate member 810. The rods 840 are arranged to define a central space 849, which runs axially parallel to the longitudinal axis of the first elongate member 810, for the cylindrical mesh drain 808 to reside. The rods 840 may allow for less contact area against the cylindrical mesh drain 808 compared to an elongate member having a circular profile, thereby providingless frictional resistance against the cylindrical mesh drain 808 the cylindrical mesh drain 808 is pushed out of the first elongate member 810. In this example, there are four rods 840. However, the first elongate may include any number of rods (e.g., 1, 2, 3, 4, 5, 6, 7, 8, etc.).EXAMPLE
[0073] FIGS. 9A-9E show an example medical drain 900 having a cylindrical mesh drain porous internal axial drain support 930 in the form of a helical spring. FIG. 9 A shows the drain 900 in a retracted / undeployed / loaded configuration where the cylindrical mesh drain 908 is positioned within the porous internal axial drain support 930 and the first elongate member 910. The porous internal axial drain support 903 is in an axially expanded state when the drain 900 is in the retracted / undeployed / loaded configuration.
[0074] FIGS. 9B-9D show the drain in an expanded / deployed / unloaded configuration where the cylindrical mesh drain 908 is extended at least partially out of the distal end of the first elongate member 910. The cylindrical mesh drain 908 may be distally extended from the first elongate member 910 by advancing a proximal portion 916 of the handle toward a distal portion 918 of the handle. The cylindrical mesh drain 908 may slide against the inner surfaces of the porous internal axial drain support 930 as the cylindrical mesh drain 908 moves distally. The porous internal axial drain support 930 may provide a resistive spring force that allows for controlled axial distal movement of the cylindrical mesh drain 908 out of the first elongate member 910. The porous internal axial drain support 930 may also provide an additive spring force that facilitates axial proximal movement of the cylindrical mesh drain 908 into of the first elongate member 910.
[0075] The cylindrical mesh drain 908 radially expands once it is deployed from the first elongate member 910, thereby increasing the porous surface area and the draining efficiency of the cylindrical mesh drain 908. The porous internal axial drain support 930 is in an axially contracted state when the drain 900 is in the expanded / deployed / unloaded configuration. The spaces between the turns of the helically shaped porous internal axial drain support 930 correspond to openings where fluid can flow through when suction is applied through the first elongate member 910.
[0076] FIG. 9E shows a closeup view of the cylindrical mesh drain 908 within the porous internal axial drain support 903 in a loaded configuration within the first elongate member 910.
[0077] The mesh porous internal axial drain supports described herein may be made of any of a number of materials. In some examples, the porous internal axial drain support is made of a different material than the first elongate member (e.g., tube). For example, the first elongate member may be made of a polymer and / or glass material and the porous internalaxial drain support may be made of a metal material. In other examples, the porous internal axial drain support is made of the same material as the first elongate member. In some examples, the porous internal axial drain support is made of a metal material (e.g., steel, titanium and / or nitinol). For example, a helically shaped porous internal axial drain support (e.g., in FIGS. 4A-4H, 5A-5D or 9A-9E) may include a coiled metal wire. In some examples, the coiled metal wire is a spring. In some examples, the porous internal axial drain support is made of one or more polymer materials. The porous internal axial drain support may be made using any of a number of manufacturing processes, such as one or more of: injection molding, extruding, printing, metal working, heating, annealing, winding, etc.
[0078] In any of the devices described herein, the first elongate member may be made of any of a number of materials. In some examples, the first elongate member is made of visibly transparent or translucent material such that the porous internal axial drain support is visible through the walls of the first elongate member. For example, the first elongate member is made of a transparent or translucent silica-based material (e.g., glass) and / or transparent or translucent polymer material (e.g., thermoplastic urethane or PVC).
[0079] Any of the cylindrical mesh drains described herein may have an open pore structure in which pores / holes / spaces within a cylindrical mesh drain are interconnected to provide multiple channels throughout the cylindrical mesh drain. In some examples, the cylindrical mesh drain includes a porous material (e.g., fabric and / or textile), which may include woven, knitted or braided elements (e.g., filaments). In some examples, the cylindrical mesh drain may be formed of a knit, a weave, a braid, a non-woven sheet (e.g., polymer or metallic or mixes), or a flexible tube of material having pores. The cylindrical mesh drain may include any number of filaments, e.g., between 24-144 ends / filaments (e.g., between about 24-128 filaments, between about 32-98 filaments, etc.). In some examples, the filaments are formed of a material such as PET, Nylon, PP, Nitinol, Steel, Elgiloy, or some combination of these. The filament may be any appropriate diameters, such as between 0.003” to 0.025” diameter filaments (e.g., monofilaments or compound filaments). In some examples, the cylindrical mesh drain is formed of filaments (knit, woven, braided, etc.) of between 100-2000 denier (e.g. multifilament or monofilament). The cylindrical mesh drain may have a mono or multi filament structure (or a mixture thereof).
[0080] In some examples, the cylindrical mesh drain is made of a non-woven material, such as a punched material, slitted material, felt, melt blown material and / or foam material. For example, the cylindrical mesh drain may be formed by extrusion, punching, stamping, blowing, laser cutting and / or other manufacturing techniques. In some examples, the cylindrical mesh drain may include an open cell structure (e.g., open cell or reticulated foam)that includes interconnected holes / spaces (e.g., cells). In some cases, the foam is similar to some types wound dressing foams used with negative pressure. In some cases, the foam may be reinforced with an open textile structure (e.g., net-like tubes, sheets) to hold the foam together when placed under tension. For example, the foam may be a composite foam, or a fabric covered foam. In some examples, the cylindrical mesh drain includes a pore pattern, for example, with 1 mm to 4 mm holes (e.g., like perforated structures with many holes per unit area). In some examples, the cylindrical mesh 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.
[0081] The cylindrical mesh drains described herein may be made of any of a number of biocompatible materials. In some examples, the cylindrical mesh drain includes one or more polymers, such as polyethylene terephthalate (PET), polytetrafluoroethylene (PTFE), silicone and / or polyurethane. In some cases, the PTFE is an expanded polytetrafluoroethylene (ePTFE). In some cases, the polymer includes a thermoplastic or thermoset material (e.g., thermoplastic or thermoset foam). In some examples, the cylindrical mesh 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).
[0082] The term “mesh” (e.g., in cylindrical mesh drain) is not limited to structures formed by one or more strands, but may be formed of a non-woven material. The material forming the cylindrical mesh drain may be a porous filtering material such as Tyvek, filter paper, etc. or it may be (initially) non-porous and pores may be formed therein. The term “mesh” may refer to a material having an average porosity of greater than, e.g., 50%.
[0083] In any of the apparatuses described herein, the cylindrical mesh drain may be made of a flexible porous material. In some examples, the cylindrical mesh drain may be a fabric. The cylindrical mesh drain may be formed of filaments (e.g., strands) of material, such as monofilaments or multiple filaments. For example, the cylindrical mesh drain may comprise a braided polymeric monofilament having 24 or more strands (e.g., 30 or more strands, 34 or more strands, 36 or more strands, 38 or more strands, 40 or more strands, 42 or more strands, etc.).
[0084] In some examples, the cylindrical mesh drain is made of material that has particular physical characteristics. For example, the cylindrical mesh drain may be made of material that is sufficiently flexible to bend laterally (e.g., when contacting soft tissue) but sufficiently rigid such that the cylindrical mesh drain has a sufficiently high s stiffness to maintain a tubular shape once extended out of the elongate member. In some examples, the cylindrical mesh drain material creates a smooth, slippery surface for the tissue to contact, thereby reducing damage to the tissue.
[0085] The cylindrical mesh drain typically has a plurality of openings or pores where the pores are sufficiently large to allow fluids and some solid biological debris (e.g., clots, pus, coagulate) to pass easily. For example, the pores may have a pore diameter that is 0.1 mm or greater (0.2 mm or greater, 0.3 mm or greater, 0.4 mm or greater, 0.5 mm or greater, 0.6 mm or greater, 0.7 mm or greater, 0.8 mm or greater, 0.9 mm or greater 1mm or greater, 1.1 mm or greater, 1.2 mm or greater, 1.3 mm or greater, 1.4 m or greater, etc.). The pores may be formed by the spaces between the strands, e.g., in woven, braided and / or knitted cylindrical mesh drain.
[0086] The cylindrical mesh drain described herein may have any of a number of shapes. In some examples, the cylindrical mesh drain may have a tubular shape with an inner space (e.g., lumen). The tubular shape may be open at both ends or closed at one end (e.g., the distal end, e.g., forming a bag). In some cases, the cylindrical mesh drain may include multiple tubes of porous material (e.g., concentrically arranged). In some cases, the cylindrical mesh drain may be shaped into a non-tubular shape.
[0087] In any of the apparatuses, the first elongate member (e.g., tube or catheter) and / or the second elongate member (e.g., rod or inner tube or catheter), may be flexible, semi-ridged or rigid. For example, the elongate member(s) may be formed of polyurethane or silicone. The medical drains may be configured to have reasonably high column force while retaining bending flexibility. For example, they may have sufficient axial flexibility so that they can be bent around structures or non-uniform volumes within soft tissue.
[0088] In any of the examples, the proximal direction may generally be in the direction towards the hand of the user (e.g., physician, surgeon, medical technician, nurse, etc.) operating the device, and distal may generally be in the direction away from the hand of the user.
[0089] FIG. 10 is a flowchart indicating an example method of draining fluid from a body cavity. In some examples, the body cavity is post-partum uterus. The medical drain includes a cylindrical mesh drain and a first elongate member with a mesh porous internal axial drain support positioned within a lumen of the porous internal axial drain support. When the medical drain is in a loaded configuration, the cylindrical mesh drain is disposed within an inner volume of the porous internal axial drain support. The porous internal axial drain support keeps the cylindrical mesh drain in a radially compressed state. The method includes inserting the medical drain into a body channel (e.g., cervix) (step 1001). This may include penetrating a body orifice (e.g., exterior orifice of the cervix) with an insertion tip of the medical drain. The insertion tip can have a rounded distal end and a tapered outer surface that are configured for atraumatic entry into the body orifice and a body channel (e.g., cervix). Insome examples, the insertion tip is coupled to a distal end of a first elongate member of the medical drain when the insertion tip penetrates the body orifice and is advanced into the body channel. In other examples, the insertion tip is coupled to a cannula, where the insertion tip and the cannula are separate from the first elongate member when the insertion tip is penetrated through the body orifice and advanced into the body channel.
[0090] The method also includes creating a seal between an outer surface of the medical drain and the body channel (e.g., cervix) (step 1003). The medical drain may include a sealing surface that is configured to create the seal with the body channel. For example, a portion of the first elongate member (or insertion tip portion coupled to the first elongate member) may have diameter that is small enough to enter the body channel, yet large enough to create a seal with the surrounding tissue of the body channel. In some examples, the first elongate member includes a compressible and expandable plug that surrounds at least a portion of the first elongate member.
[0091] The cylindrical mesh drain can be extended distally through a distal opening of the porous internal axial drain support, the first elongate member, and into the body cavity (step 1005). The cylindrical mesh drain may slide against the inner walls of porous internal axial drain support when moving distally through the porous internal axial drain support. In some examples, the porous internal axial drain support compresses axially as the cylindrical mesh drain moves through the porous internal axial drain support. The porous internal axial drain support may have a helical shape, tubular shape, or other shape conducive for supporting the cylindrical mesh drain. In some examples, porous internal axial drain support includes a spring that provides a spring force. The spring may be arranged to provide a resistive spring force against the second elongate member, thereby providing controlled release of the cylindrical mesh drain from the porous internal axial drain support and first elongate member.
[0092] In some examples, extending the cylindrical mesh drain includes pushing a second elongate member that is coupled to the cylindrical mesh drain through the first elongate member. A handle may be configured to lock an axial position of the second elongate member with respect to the first elongate member. The cylindrical mesh drain may be configured to radially expand when released from the first elongate member and take on a shape that can distribute suction throughout the body cavity. In some examples, the cylindrical mesh drain has a tubular shape when extended from the first elongate member.
[0093] Suction may be applied to through the cylindrical mesh drain and the first elongate member to drain fluid proximally from the body cavity (e.g., postpartum uterus) (1007). The cylindrical mesh drain may be configured to provide multiple flow paths forfluid / material to flow through when the suction is applied through the first elongate member to drain the fluid / material proximally through the cylindrical mesh drain and the first elongate member. The cylindrical mesh drain may have pores of sufficient size to allow passage of fluids (e.g., blood, lymph, pus), gasses and / or other materials (e.g., coagulate, etc.) to pass without significant resistance. The pores may also be of sufficient size to avoid clogging (e.g., with tissue (e.g. blood clots)). In some cases, the suction may apply sufficient negative pressure to walls of the body cavity to cause the body cavity to contract, which can reduce hemorrhaging. The porous internal axial drain support may include openings or pores that allow fluid to pass through the walls of the porous internal axial drain support and into the internal volume of the porous internal axial drain support, thereby increasing the fluid removal efficiency.
[0094] In some cases, the suction may optionally be maintained for a period of time (step 1009). For example, it may take time for the negative pressure to cause the walls of the body cavity (e.g., uterus) to contract and mitigate hemorrhaging. However, it may not be desirable to keep the cylindrical mesh drain within the body cavity for too long in order to prevent tissue adhesion to the cylindrical mesh drain. In some examples, the suction may be maintained for between about 1 minute and 96 hours (e.g., between 24-78 hours, up to 96 hours, up to 80 hours, up to 72 hours, etc.).
[0095] Once the body cavity is sufficiently drained, and in some cases when hemorrhaging sufficiently reduced, the suction may be removed and the medical drain withdrawn from the body region (e.g., body cavity, channel and body orifice) (step 1011). In some cases, withdrawing the medical drain includes withdrawing the cylindrical mesh drain back into the porous internal axial drain support and the first elongate member. In cases where a second elongate member is coupled to the cylindrical mesh drain, this may be accomplished by pulling the second elongate member proximally (e.g., at a handle of the medical drain). In some cases where the porous internal axial drain support includes a spring, the spring may be arranged to provide a spring force that facilitates the retraction of the cylindrical mesh drain into the porous internal axial drain support.
[0096] When a feature or element is herein referred to as being “on” another feature or element, it can be directly on the other feature or element or intervening features and / or elements may also be present. In contrast, when a feature or element is referred to as being “directly on” another feature or element, there are no intervening features or elements present. It will also be understood that, when a feature or element is referred to as being “connected”, “attached” or “coupled” to another feature or element, it can be directly connected, attached or coupled to the other feature or element or intervening features orelements may be present. In contrast, when a feature or element is referred to as being “directly connected”, “directly attached” or “directly coupled” to another feature or element, there are no intervening features or elements present. Although described or shown with respect to one embodiment, the features and elements so described or shown can apply to other embodiments. It will also be appreciated by those of skill in the art that references to a structure or feature that is disposed “adjacent” another feature may have portions that overlap or underlie the adjacent feature.
[0097] Terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. For example, as used herein, the singular forms “a”, “an” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms “comprises” and / or “comprising,” when used in this specification, specify the presence of stated features, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and / or groups thereof. As used herein, the term “and / or” includes any and all combinations of one or more of the associated listed items and may be abbreviated as “ / ”.
[0098] Spatially relative terms, such as “under”, “below”, “lower”, “over”, “upper” and the like, may be used herein for ease of description to describe one element or feature's relationship to another element(s) or feature(s) as illustrated in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if a device in the figures is inverted, elements described as “under” or “beneath” other elements or features would then be oriented “over” the other elements or features. Thus, the exemplary term “under” can encompass both an orientation of over and under. The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly. Similarly, the terms “upwardly”, “downwardly”, “vertical”, “horizontal” and the like are used herein for the purpose of explanation only unless specifically indicated otherwise.
[0099] Although the terms “first” and “second” may be used herein to describe various features / elements (including steps), these features / elements should not be limited by these terms, unless the context indicates otherwise. These terms may be used to distinguish one feature / element from another feature / element. Thus, a first feature / element discussed below could be termed a second feature / element, and similarly, a second feature / element discussed below could be termed a first feature / element without departing from the teachings of the present invention.
[0100] Throughout this specification and the claims which follow, unless the context requires otherwise, the word “comprise”, and variations such as “comprises” and “comprising” means various components can be co-jointly employed in the methods and articles (e.g., compositions and apparatuses including device and methods). For example, the term “comprising” will be understood to imply the inclusion of any stated elements or steps but not the exclusion of any other elements or steps.
[0101] In general, any of the apparatuses and methods described herein should be understood to be inclusive, but all or a sub-set of the components and / or steps may alternatively be exclusive, and may be expressed as “consisting of’ or alternatively “consisting essentially of’ the various components, steps, sub-components or sub-steps.
[0102] As used herein in the specification and claims, including as used in the examples and unless otherwise expressly specified, all numbers may be read as if prefaced by the word “about” or “approximately,” even if the term does not expressly appear. The phrase “about” or “approximately” may be used when describing magnitude and / or position to indicate that the value and / or position described is within a reasonable expected range of values and / or positions. For example, a numeric value may have a value that is + / - 0.1% of the stated value (or range of values), + / - 1% of the stated value (or range of values), + / - 2% of the stated value (or range of values), + / - 5% of the stated value (or range of values), + / - 10% of the stated value (or range of values), etc. Any numerical values given herein should also be understood to include about or approximately that value, unless the context indicates otherwise. For example, if the value “10” is disclosed, then “about 10” is also disclosed. Any numerical range recited herein is intended to include all sub-ranges subsumed therein. It is also understood that when a value is disclosed that “less than or equal to” the value, “greater than or equal to the value” and possible ranges between values are also disclosed, as appropriately understood by the skilled artisan. For example, if the value “X” is disclosed the “less than or equal to X” as well as “greater than or equal to X” (e.g., where X is a numerical value) is also disclosed. It is also understood that the throughout the application, data is provided in a number of different formats, and that this data, represents endpoints and starting points, and ranges for any combination of the data points. For example, if a particular data point “10” and a particular data point “15” are disclosed, it is understood that greater than, greater than or equal to, less than, less than or equal to, and equal to 10 and 15 are considered disclosed as well as between 10 and 15. It is also understood that each unit between two particular units are also disclosed. For example, if 10 and 15 are disclosed, then 11, 12, 13, and 14 are also disclosed.
[0103] Although various illustrative embodiments are described above, any of a number of changes may be made to various embodiments without departing from the scope of the invention as described by the claims. For example, the order in which various described method steps are performed may often be changed in alternative embodiments, and in other alternative embodiments one or more method steps may be skipped altogether. Optional features of various device and system embodiments may be included in some embodiments and not in others. Therefore, the foregoing description is provided primarily for exemplary purposes and should not be interpreted to limit the scope of the invention as it is set forth in the claims.
[0104] The examples and illustrations included herein show, by way of illustration and not of limitation, specific embodiments in which the subject matter may be practiced. As mentioned, other embodiments may be utilized and derived there from, such that structural and logical substitutions and changes may be made without departing from the scope of this disclosure. Such embodiments of the inventive subject matter may be referred to herein individually or collectively by the term “invention” merely for convenience and without intending to voluntarily limit the scope of this application to any single invention or inventive concept, if more than one is, in fact, disclosed. Thus, although specific embodiments have been illustrated and described herein, any arrangement calculated to achieve the same purpose may be substituted for the specific embodiments shown. This disclosure is intended to cover any and all adaptations or variations of various embodiments. Combinations of the above embodiments, and other embodiments not specifically described herein, will be apparent to those of skill in the art upon reviewing the above description.
Claims
CLAIMSWhat is claimed is:
1. A medical drain, comprising: a first elongate member comprising a suction lumen having a distal opening; a second elongate member that is slidably disposed in the suction lumen; a cylindrical mesh drain coupled to the second elongate member and having a constricted first configuration and an expanded second configuration; and a porous internal axial drain support extending within the suction lumen, the porous internal axial drain support configured to hold the cylindrical mesh drain in the constricted first configuration within the suction lumen, wherein distal movement of the second elongate member causes the cylindrical mesh drain to extend distally out of the suction lumen into the expanded second configuration, further wherein the cylindrical mesh drain and the porous internal axial drain support provides a plurality of flow paths for fluid to flow through and into the suction lumen when the cylindrical mesh drain is extended from the distal opening of the first elongate member and suction is applied through the suction lumen.
2. The medical drain of claim 1, wherein the cylindrical mesh drain is biased to expand radially outward from the constricted first configuration to the expanded second configuration.
3. The medical drain of claim 1, wherein proximal movement of the second elongate member causes the cylindrical mesh drain to retract at least partially into the suction lumen so that the internal axial drain support collapses the cylindrical mesh drain into the constricted first configuration within the suction lumen.
4. The medical drain of claim 1, wherein the porous internal axial drain support comprises a plurality of openings that allow fluid to pass through the porous internal axial drain support.
5. The medical drain of claim 1, wherein the porous internal axial drain support has a helical shape.
6. The medical drain of claim 1, wherein the porous internal axial drain support comprises a spring.
7. The medical drain of claim 1, wherein the porous internal axial drain support comprises a plurality of openings that are configured to allow fluid to flow through walls of the porous internal axial drain support.
8. The medical drain of claim 1, wherein the porous internal axial drain support includes an outer surface with multiple standoffs that are configured to maintain a radial position of the porous internal axial drain support with respect to the suction lumen.
9. The medical drain of claim 1, wherein the porous internal axial drain support is configured to prevent the cylindrical mesh drain from contacting a wall of the suction lumen.
10. The medical drain of claim 1, wherein the porous internal axial drain support comprises one or more rods within the suction lumen, wherein the rods are configured to decrease frictional resistance against the cylindrical mesh drain when the cylindrical mesh drain moves axially within the first elongate member.
11. The medical drain of claim 1, wherein the porous internal axial drain support is configured to provide a resistive force in a proximal direction as the cylindrical mesh drain is extended out of the distal opening of the first elongate member.
12. The medical drain of claim 11, wherein the resistive force ranges from about 5 to 200 grams per 2.5cm.
13. The medical drain of claim 1, wherein the cylindrical mesh drain is configured to radially expand as the cylindrical mesh drain is extended distally out of the distal opening of the first elongate member.
14. The medical drain of claim 1, wherein the porous internal axial drain support is configured to radially constrain the cylindrical mesh drain within the suction lumen.
15. The medical drain of claim 1, wherein the porous internal axial drain support is made of a metal material.
16. The medical drain of claim 1, wherein the porous internal axial drain support is made of a polymer material.
17. The medical drain of claim 1, wherein the first elongate member is made of a visibly transparent material such that the porous internal axial drain support is viewable through the first elongate member.
18. The medical drain of claim 1, wherein the cylindrical mesh drain has a tubular shape when expanded.
19. The medical drain of claim 1, further comprising a handle that is operationally coupled to the second elongate member.
20. The medical drain of claim 19, wherein pushing a knob of the handle causes the second elongate member to move distally within the suction lumen, and pulling the knob causes the second elongate member to move proximally within the suction lumen.
21. The medical drain of claim 19, wherein the handle includes a lock that is configured to lock axial movement of the second elongate member.
22. The medical drain of claim 1, further comprising an insertion tip coupled to a distal end of the first elongate member, the insertion tip having a rounded outer surface configured for atraumatic contact with body tissue.
23. The medical drain of claim 22, wherein the insertion tip is sized and shaped to create a seal with a non-dilated or minimally dilated cervix.
24. The medical drain of claim 1, wherein the second elongate member is a rod or tube.
25. The medical drain of claim 1, wherein the cylindrical mesh drain has a larger pore size in the expanded second configuration.
26. The medical drain of claim 1, wherein when the cylindrical mesh drain is extended distally out of the porous internal axial drain support, the porous internal axial drain support has an axially varied porosity where a distal portion of the porous internal axial drain support is more porous than a proximal portion of the porous internal axial drain support.
27. The medical drain of claim 26, wherein the porous internal axial drain support has a helical shape with a varied pitch.
28. A method of draining a body cavity, the method comprising:inserting first elongate member of a medical drain in an orifice or body channel that leads to the body cavity, wherein a cylindrical mesh drain is supported within a suction lumen of the first elongate member by a porous internal axial drain support that prevents the cylindrical mesh drain from contacting a wall of the suction lumen; moving a second elongate member distally within the suction lumen, thereby causing the cylindrical mesh drain to extend distally at least partially out of the inner volume of the porous internal axial drain support and to expand radially outwards into the body cavity; and applying suction through the cylindrical mesh drain so that fluid passes through a plurality of flow paths of the cylindrical mesh drain and through the porous internal axial drain support into the suction lumen.
29. The method of claim 28, wherein moving the second elongate member distally relative to the first elongate member causes the porous internal axial drain support to expand radially outwards, thereby increasing a pore size of the cylindrical mesh drain.
30. The method of claim 28, further comprising moving the second elongate member proximally within the first elongate member causes the cylindrical mesh drain to retract at least partially within the suction lumen of the porous internal axial drain support.
31. The method of claim 28, further comprising, prior to applying the suction, creating a seal between the first elongate member and the orifice or the body channel.
32. The method of claim 31, wherein the seal is created between a distal portion of the first elongate member and the orifice or the body channel.
33. The method of claim 28, wherein applying the suction causes fluid to pass through openings within a wall of the porous internal axial drain support.
34. The method of claim 28, wherein the porous internal axial drain support comprises a spring that provides a resistive force in a proximal direction as the cylindrical mesh drain is extended distally at least partially out of the inner volume of the porous internal axial drain support, the first elongate member, and into the body cavity.
Citation Information
Patent Citations
Filtration and entrapment apparatus and method of use
US20160296315A1
Medical drain device
US20180235743A1
Small tube tissue biopsy
US20200323520A1
Rolling surgical drains and methods for use
US20230241303A1
Surgical drain methods and articles
WO2022140784A1