Transcutaneous ultrafiltration

Abstract

1. A fluid extraction chamber suitable for implantation in a non-inflated peritoneal cavity, comprising: an elongated, expandable body having a major axis and a minor axis, the elongated, expandable body being configured to move from a collapsed state to an expanded state when deployed in the non-inflated peritoneal cavity, the elongated, expandable body including a fluid-permeable wall defining an interior volume of the elongated, expandable body, the collapsed state being shaped and sized to penetrate an opening in the abdominal wall to reach the non-inflated peritoneal cavity, and the expanded state being thin and having a surface area at least five times greater than the surface area of ​​the elongated, expandable body in the collapsed state; and an outlet coupled to the elongated, expandable body having at least one opening to the interior volume.

Description

[Technical Field]

[0001] Related Applications This application claims the benefit of priority under 35 U.S.C. §119(e) of U.S. Provisional Patent Application No. 63 / 436,129, filed December 30, 2022, the contents of which are incorporated herein by reference in their entirety.

[0002] The present invention, in some embodiments thereof, relates to ultrafiltration devices and methods, and more particularly, but not exclusively, to percutaneously implantable ultrafiltration devices and methods. Summary of the Invention

[0003] Some examples of some embodiments of the present invention are listed below (an embodiment may include features from more than one example and / or fewer than all features of an example). Example 1. A fluid extraction chamber suitable for implantation into a non-pneumoperitoneal peritoneal cavity, comprising: an elongate expandable body having a major axis and a minor axis and configured to move from a collapsed state to an expanded state when deployed within the non-pneumoperitoneal cavity, the elongate expandable body including a fluid permeable wall defining an interior volume of the elongate expandable body; an elongated, expandable body that, in a collapsed state, is shaped and sized to penetrate an opening in an abdominal wall to reach a non-pneumoperitoneal cavity, and that, in an expanded state, is thin and has a surface area that is at least five times greater than the surface area of ​​the elongated, expandable body in the collapsed state; an outlet coupled to the elongate, expandable body having at least one opening to the interior volume;

[0004] Example 2. The chamber of Example 1, wherein said chamber is suitable for implantation into said unfilled peritoneal cavity under local anesthesia.

[0005] Example 3. The chamber of any one of Examples 1 to 2, wherein the maximum width of the elongate expandable body in the expanded state is at least three times greater than the maximum width of the elongate expandable body in the collapsed state.

[0006] Example 4. The chamber of any one of the preceding examples, comprising an elastic porous skeleton in the interior volume in contact with the interior surface of the fluid permeable wall, the elastic porous skeleton configured to exert a force against the interior surface and to collapse when the elongate body is in a collapsed state and to expand when the elongate expandable body is in an expanded state when deployed in the non-inflated peritoneal cavity.

[0007] Example 5. The chamber of Example 4, wherein the elastic porous scaffold comprises at least one layer of elastic semi-rigid mesh.

[0008] Example 6. The chamber of example 4 or 5, wherein the elastic porous scaffold is shaped as a sponge.

[0009] Example 7. The chamber of any one of Examples 4-6, wherein the pores of the elastic porous scaffold have similar sizes and / or shapes.

[0010] Example 8. The chamber of any one of Examples 4-6, wherein the pores of the elastic porous scaffold have various sizes and / or shapes.

[0011] Example 9. The chamber of any one of Examples 4-8, wherein the elastic porous scaffold includes a supporting structure and / or supporting material configured to allow expansion of the elastic porous scaffold when the elastic porous scaffold is stretched.

[0012] Example 10. A chamber described in any one of Examples 4 to 9, wherein the elastic porous skeleton includes integrated channels that converge into the outlet, the integrated channels being shaped and sized to direct fluid entering the internal volume through different portions of the body toward the outlet.

[0013] Example 11. The chamber of any one of the preceding examples, wherein the thickness of the body in the expanded state is less than 2 mm.

[0014] Example 12. A chamber according to any one of the preceding examples, wherein the ratio between the width and length of the body in the expanded state is at least 1:1.5.

[0015] Example 13. The chamber of any one of the preceding examples, wherein the ratio between the length and width of the elongate expandable body in the collapsed state is at least 5:1.

[0016] Example 14. The chamber of any one of the preceding examples, wherein the maximum width of the elongate expandable body in the collapsed state is less than 10 mm.

[0017] Example 15. The chamber of any one of the preceding examples, wherein in the expanded state, the body includes a flexible stylet configured to push outward against the fluid-permeable wall.

[0018] Example 16. The chamber of Example 15, wherein the flexible stylet is integrated into the body.

[0019] Example 17. The chamber of Example 15, wherein the body includes a circumferential channel configured to receive the flexible stylet, and the flexible stylet is configured to be inserted through the outlet into the circumferential channel via the outlet when the elongate expandable body is within the abdominal cavity.

[0020] Example 18. The chamber of Example 15, wherein the flexible stylet is configured to be inserted into the internal volume through the outlet.

[0021] Example 19. A chamber described in any one of Examples 15 to 18, wherein the flexible stylet is a bi-state flexible stylet configured to move between a collapsed state and an expanded state.

[0022] Example 20. The chamber of any one of the preceding examples, comprising a jacket disposed around the elongate expandable body when the elongate expandable body is in the collapsed state.

[0023] Example 21. A chamber as described in Example 20, wherein the jacket is configured to increase the longitudinal stiffness of the elongate expandable body.

[0024] Example 22. A chamber described in Example 20 or 21, comprising one or more threads attached to the jacket and configured to allow removal of the jacket from the elongated expandable body from outside the abdominal cavity.

[0025] Example 23. A chamber described in any one of Examples 20 to 22, wherein the jacket is formed from a dissolvable material configured to dissolve upon interaction with fluid in the abdominal cavity.

[0026] Example 24. A chamber according to any one of the preceding examples, wherein an inner surface of the fluid-permeable wall facing the interior volume is coated with a degradable coating configured to seal the fluid-permeable wall from the passage of fluid therethrough.

[0027] Example 25 The chamber of Example 24, wherein the coating is a hydrophobic coating.

[0028] Example 26. The chamber of any one of the preceding examples, comprising a perforated tube coupled to the outlet and extending into the interior volume.

[0029] Example 27. The chamber of any one of the preceding examples, wherein the wall comprises at least one membrane layer having pores with sizes ranging from 0.1 μm to 100 μm.

[0030] Example 28. The chamber of any one of the preceding examples, wherein the fluid-permeable wall is at least partially formed from at least two types of membranes, and wherein pores of at least one membrane of the at least two membrane types are configured to open to allow passage of fluid under a pressure level that is a different form of pressure level required for opening pores of a second membrane of at least one of the at least two membrane types.

[0031] Example 29. A chamber according to any one of the preceding examples, wherein the outlet comprises at least one flow path and a filter valve within the flow path, the filter valve configured to allow fluid to pass therethrough when the valve is closed and to open when a tool is inserted through the outlet towards the internal volume.

[0032] Example 30. A chamber according to any one of the preceding examples, wherein the outlet comprises at least two separate flow paths into the internal volume, at least one flow path being used for extracting fluid from the internal volume and at least one second flow path being used for introducing toxin-binding beads into the internal volume.

[0033] Example 31. A fluid removal system, comprising: A chamber according to claim 1; an inflatable seal including at least one tube traversing the inflatable seal, the tube configured to be fluidly coupled to the outlet, the inflatable seal positioned in the abdominal wall opening and configured to seal a gap between the abdominal wall and the tube when inflated.

[0034] Example 32. A fluid removal system, comprising: A chamber according to claim 1; a tube configured to traverse the abdominal wall through the opening, at least one end of the tube coupled to the outlet and at least one second end of the tube configured to be positioned outside the patient's body, the tube including at least two separate channels passing therethrough, an end of a first channel of at least one of the at least two separate channels fluidly coupled to the outlet and an end of a second channel of at least one of the at least two separate channels fluidly coupled to the non-pneumoperitoneal peritoneal cavity.

[0035] Example 33. The system of Example 32, wherein the at least one second channel is a tool channel configured to allow insertion of a tool into the abdominal cavity from outside the body while the at least one first channel is fluidly coupled to the outlet.

[0036] Example 34. An expandable seal, an expandable body shaped and sized to be positioned within the opening in the abdominal wall and configured to move between a collapsed state and an expanded state; and at least one tube traversing the expandable body, the at least one tube including at least one opening configured to be positioned within the abdominal cavity and at least one opening configured to be positioned outside the abdominal cavity, wherein the expandable body is configured to seal a gap between the abdominal wall and the at least one tube when expanded.

[0037] Example 35. The seal of Example 34, wherein the expandable body includes a balloon and an inflation port for the balloon.

[0038] Example 36. The seal of example 34 or 35, wherein the tube comprises at least two separate flow paths.

[0039] Example 37. A fluid extraction chamber suitable for implantation into the abdominal cavity, comprising: 1. A fluid extraction chamber comprising: an expandable body configured to move from a collapsed state to an expanded state, the expandable body including a fluid-permeable wall including at least one layer of a porous membrane, the fluid-permeable wall defining an interior volume of the body, an inner layer of the fluid-permeable wall being coated with a degradable coating, and in the collapsed state, the expandable body is shaped and sized to penetrate an opening in an abdominal wall into an abdominal cavity and to expand within the abdominal cavity by infusing a fluid into the interior volume, the degradable coating being configured to temporarily seal pores in the membrane to prevent the infused fluid from leaving the interior volume and passing through the fluid-permeable wall.

[0040] Example 38. The chamber of Example 37, wherein the coating is a hydrophobic coating.

[0041] Example 39. A method for deploying an elongated fluid extraction chamber, comprising: locally anesthetizing an area within the abdominal wall of a selected target subject to form an opening through the abdominal wall into the non-pneumoperitoneal peritoneal cavity; forming the opening in the target area; introducing an elongated fluid extraction chamber in a collapsed state through the opening into the non-pneumoperitoneum abdominal cavity, the elongated fluid extraction chamber having a fluid-permeable wall defining an interior volume and an outlet for the interior volume; and expanding the elongated fluid extraction chamber within the non-pneumoperitoneal cavity to obtain a surface area at least five times greater than the surface area of ​​the elongated fluid extraction chamber in the collapsed state.

[0042] Example 40. The method of Example 39, wherein the expanding comprises expanding the elongated fluid extraction chamber to have an outer flat surface and a thickness of less than 2 mm.

[0043] Example 41. The method described in Example 39 or 40, wherein the expanding comprises expanding the elongated fluid extraction chamber by introducing a stylet into the internal volume or into a circumferential channel of the fluid-permeable wall.

[0044] Example 42. A method according to any one of Examples 39 to 41, wherein the fluid extraction chamber includes an integrated stylet configured to move between a collapsed state and an expanded state, and the expanding includes expanding the fluid extraction chamber by moving the stylet to the expanded state.

[0045] Example 43. A method according to any one of Examples 39 to 42, wherein the inner layer of the fluid-permeable wall comprises a degradable sealing layer configured to temporarily seal the fluid-permeable wall from the passage of fluid, and wherein the expanding comprises expanding the elongated fluid extraction chamber by injecting fluid into the internal volume.

[0046] Example 44. 44. The method of any one of Examples 39-43, comprising, following the expansion, intermittently applying a negative pressure to the internal volume through the outlet sufficient to draw fluid from the non-pneumoperitoneal peritoneal cavity through the fluid-permeable wall into the internal volume and out of the internal volume through the outlet.

[0047] Example 45. The method of any one of Examples 39 to 44, comprising diagnosing the subject with chronic heart failure or acute heart failure prior to the administration of local anesthesia.

[0048] Example 46. The method of any one of Examples 39 to 44, comprising detecting ascites in the subject prior to said local anesthesia.

[0049] Example 47. Detecting protein-bound uremic toxins (PBUTs) in the subject; 45. The method of any one of Examples 39-44, comprising: following the expanding, introducing beads into the interior volume, the beads configured to bind the PBUT.

[0050] Listed below are some additional examples of some embodiments of the present invention (an embodiment may include features from multiple examples and / or fewer than all features of an example). Example 1. A fluid extraction chamber suitable for implantation into a non-pneumoperitoneal peritoneal cavity, comprising: an elongate expandable body having a major axis and a minor axis and configured to move from a collapsed state to an expanded state when deployed within the non-pneumoperitoneal cavity, the elongate expandable body including a fluid permeable wall defining an interior volume of the elongate expandable body; an elongated, expandable body that, in a collapsed state, is shaped and sized to penetrate an opening in an abdominal wall to reach a non-pneumoperitoneal cavity, and that, in an expanded state, is thin and has a surface area that is at least five times greater than the surface area of ​​the elongated, expandable body in the collapsed state; an outlet coupled to the elongate, expandable body having at least one opening to the interior volume;

[0051] Example 2. The chamber of Example 1, wherein said chamber is suitable for implantation into said unfilled peritoneal cavity under local anesthesia.

[0052] Example 3. The chamber of any one of Examples 1 to 2, wherein the maximum width of the elongate expandable body in the expanded state is at least three times greater than the maximum width of the elongate expandable body in the collapsed state.

[0053] Example 4. The chamber of any one of the preceding examples, comprising an elastic porous skeleton in the interior volume in contact with the interior surface of the fluid permeable wall, the elastic porous skeleton configured to exert a force against the interior surface and to collapse when the elongate body is in a collapsed state and to expand when the elongate expandable body is in an expanded state when deployed in the non-inflated peritoneal cavity.

[0054] Example 5. The chamber of Example 4, wherein the elastic porous scaffold comprises at least one layer of elastic semi-rigid mesh.

[0055] Example 6. The chamber of example 4 or 5, wherein the elastic porous scaffold is shaped as a sponge.

[0056] Example 7. The chamber of any one of Examples 4-6, wherein the pores of the elastic porous scaffold have similar sizes and / or shapes.

[0057] Example 8. The chamber of any one of Examples 4-6, wherein the pores of the elastic porous scaffold have various sizes and / or shapes.

[0058] Example 9. The chamber of any one of Examples 4-8, wherein the elastic porous scaffold includes a supporting structure and / or supporting material configured to allow expansion of the elastic porous scaffold when the elastic porous scaffold is stretched.

[0059] Example 10. A chamber described in any one of Examples 4 to 9, wherein the elastic porous skeleton includes integrated channels that converge into the outlet, the integrated channels being shaped and sized to direct fluid entering the internal volume through different portions of the body toward the outlet.

[0060] Example 11. The chamber of any one of the preceding examples, wherein in the expanded state, the elongate expandable body is substantially flat and thin, having a maximum thickness of less than 2 mm along at least 90% of the width of the body.

[0061] Example 12. A chamber according to any one of the preceding examples, wherein the ratio between the width and length of said body in the expanded state is at least 1:1.4.

[0062] Example 13. The chamber of any one of the preceding examples, wherein the ratio between the length and width of the elongate expandable body in the collapsed state is at least 3:1.

[0063] Example 14. The chamber of any one of the preceding examples, wherein the maximum width of the elongate expandable body in the collapsed state is less than 10 mm.

[0064] Example 15. The chamber of any one of the preceding examples, wherein in the expanded state, the body includes a flexible stylet configured to push outward against the fluid-permeable wall.

[0065] Example 16. The chamber of Example 15, wherein the flexible stylet is integrated into the body.

[0066] Example 17. The chamber of Example 15, wherein the body includes a circumferential channel configured to receive the flexible stylet, and the flexible stylet is configured to be inserted through the outlet into the circumferential channel via the outlet when the elongate expandable body is within the abdominal cavity.

[0067] Example 18. The chamber of Example 15, wherein the flexible stylet is configured to be inserted into the internal volume through the outlet.

[0068] Example 19. A chamber described in any one of Examples 15 to 18, wherein the flexible stylet is a bi-state flexible stylet configured to move between a collapsed state and an expanded state.

[0069] Example 20. A chamber according to any one of the preceding examples, comprising a jacket disposed around the elongate expandable body when the elongate expandable body is in the collapsed state, the jacket configured to increase the longitudinal stiffness of the elongate expandable body.

[0070] Example 21. The chamber of Example 20, comprising one or more threads coupled to the jacket and configured to allow removal of the jacket from the elongate expandable body from outside the abdominal cavity.

[0071] Example 22. A chamber according to Example 20 or 21, wherein the jacket is formed from a dissolvable material configured to dissolve upon interaction with fluid in the abdominal cavity.

[0072] Example 23. A chamber according to any one of the preceding examples, wherein an inner surface of the fluid-permeable wall facing the interior volume is coated with a degradable coating configured to seal the fluid-permeable wall from the passage of fluid therethrough.

[0073] Example 24. The chamber of Example 23, wherein the coating is a hydrophobic coating.

[0074] Example 25. The chamber of any one of the preceding examples, comprising a perforated tube coupled to the outlet and extending into the interior volume.

[0075] Example 26. The chamber of any one of the preceding examples, wherein the wall comprises at least one membrane layer having pores with sizes ranging from 0.1 μm to 100 μm.

[0076] Example 27. The chamber of any one of the preceding examples, wherein the fluid-permeable wall is at least partially formed from at least two types of membranes, and wherein pores of at least one membrane of the at least two membrane types are configured to open to allow passage of fluid under a pressure level that is a different form of pressure level required for opening pores of a second membrane of at least one of the at least two membrane types.

[0077] Example 28. A chamber according to any one of the preceding examples, wherein the outlet comprises at least one flow path and a filter valve within the flow path, the filter valve configured to allow fluid to pass therethrough when the valve is closed and to open when a tool is inserted through the outlet towards the internal volume.

[0078] Example 29. A chamber according to any one of the preceding examples, wherein the outlet comprises at least two separate flow paths into the internal volume, at least one flow path being used for extracting fluid from the internal volume and at least one second flow path being used for introducing toxin-binding beads into the internal volume.

[0079] Example 30. A fluid removal system, comprising: A chamber according to claim 1; an inflatable seal including at least one tube traversing the inflatable seal; The fluid removal system, wherein the tube is configured to be fluidly coupled to the outlet, and the inflatable seal is positioned in the abdominal wall opening and configured to seal a gap between the abdominal wall and the tube when inflated.

[0080] Example 31. A fluid removal system, comprising: a chamber as described in Example 1; a tube configured to traverse the abdominal wall through the opening, at least one end of the tube coupled to the outlet and at least one second end of the tube configured to be positioned outside the patient's body, the tube including at least two separate channels passing therethrough, an end of a first channel of at least one of the at least two separate channels fluidly coupled to the outlet and an end of a second channel of at least one of the at least two separate channels fluidly coupled to the non-pneumoperitoneal peritoneal cavity.

[0081] Example 32. The system of Example 31, wherein the at least one second channel is a tool channel configured to allow insertion of a tool into the abdominal cavity from outside the body while the at least one first channel is fluidly coupled to the outlet.

[0082] Example 33. An expandable seal, an expandable body shaped and sized to be positioned within the opening in the abdominal wall and configured to move between a collapsed state and an expanded state; and at least one tube traversing the expandable body, the at least one tube including at least one opening configured to be positioned within the abdominal cavity and at least one opening configured to be positioned outside the abdominal cavity, wherein the expandable body is configured to seal a gap between the abdominal wall and the at least one tube when expanded.

[0083] Example 34. A fluid extraction chamber suitable for implantation into the abdominal cavity, comprising: 1. A fluid extraction chamber comprising: an expandable body configured to move from a collapsed state to an expanded state, the expandable body including a fluid-permeable wall including at least one layer of a porous membrane, the fluid-permeable wall defining an interior volume of the body, an inner layer of the fluid-permeable wall being coated with a degradable coating, and in the collapsed state, the expandable body is shaped and sized to penetrate an opening in an abdominal wall into an abdominal cavity and to expand within the abdominal cavity by infusing a fluid into the interior volume, the degradable coating being configured to temporarily seal pores in the membrane to prevent the infused fluid from leaving the interior volume and passing through the fluid-permeable wall.

[0084] Example 35. The chamber of Example 34, wherein the coating is a hydrophobic coating.

[0085] Example 36. A fluid extraction chamber suitable for implantation into a body cavity, comprising: an elongate expandable body configured to transition from a collapsed state to an expanded state upon deployment within the body lumen, the elongate expandable body including a fluid permeable wall defining an interior volume of the elongate expandable body; an outlet coupled to the elongate expandable body, the outlet having at least one opening into the interior volume; and at least one flexible, elongated stylet positioned within the internal volume and at least partially coupled to the outlet or the body when the elongated, expandable body is introduced into the body cavity, the at least one flexible, elongated stylet configured to push outwardly against the fluid-permeable wall from within the internal volume to expand the elongated, expandable body within the body cavity during the deployment of the elongated, expandable body.

[0086] Example 37. The chamber of Example 36, wherein the elongate expandable body has a major axis and a minor axis.

[0087] Example 38. A chamber described in Example 36 or 37, wherein the at least one elongated flexible stylet has a distal end mechanically coupled to the outlet and a proximal end configured to be introduced into the internal volume during deployment of the elongated expandable body and mechanically coupled to the outlet.

[0088] Example 39. A chamber as described in Example 38, wherein the proximal end of the at least one elongated flexible stylet includes an extension shaped and sized to match the recess of the outlet.

[0089] Example 40. A chamber described in Example 36 or 37, wherein the at least one elongated flexible stylet is integrated with the elongated expandable body and positioned within the internal volume while the elongated expandable body is inserted into the body cavity, and the at least one elongated flexible stylet is configured to fold into two or more partially overlapping ring-shaped portions when the elongated expandable body is in a folded state and to expand into a single ring-shaped portion when the elongated expandable body is deployed within the body cavity.

[0090] Example 41. A chamber described in any one of Examples 36 to 40, wherein the at least one elongated flexible stylet includes at least one outer stylet and at least one inner stylet, and when the elongated expandable body is in an expanded state, the at least one outer stylet pushes the fluid-permeable wall outward, and the at least one inner stylet is positioned between the at least one outer stylet and the center point of the internal volume.

[0091] Example 42. A chamber described in any one of Examples 36 to 41, comprising an elongated deployment tool having a distal end reversibly coupled to the at least one flexible, elongated stylet and / or the elongated, expandable body and a proximal end positioned outside the body cavity, wherein movement of the proximal end applies a force to the at least one flexible, elongated stylet and / or the elongated, expandable body sufficient to expand the elongated, expandable body within the body cavity.

[0092] Example 43. The chamber described in Example 42, wherein the elongate deployment tool includes at least one elongate rod that enters the internal volume through the outlet, the at least one elongate rod having a distal end reversibly coupled to the at least one flexible elongate stylet and a proximal end located outside the body cavity, and axial advancement and / or rotation of the proximal end moves the at least one flexible elongate stylet from a collapsed state to an expanded state.

[0093] Example 44. The outlet comprises at least two outlet openings, and the elongate deployment tool comprises at least two elongate rods, each entering the interior volume through a different one of the at least two outlet openings; 43. The chamber of claim 42, wherein when the elongate expandable body is within the body cavity, movement of the proximal ends of the at least two elongate rods relative to each other applies a force to the fluid-permeable wall sufficient to expand the elongate expandable body within the body cavity.

[0094] Example 45. The elongate deployment tool includes at least two elongate rods reversibly operably coupled to the elongate expandable body on opposite sides of the elongate expandable body; 43. The chamber of claim 42, wherein when the elongate expandable body is within the body cavity, movement of the proximal ends of the at least two elongate rods relative to each other applies a force to the elongate expandable body sufficient to expand the elongate expandable body within the body cavity.

[0095] Example 46. The elongated deployment tool includes an expansion tray, the expansion tray including an elongated plate, at least two arms pivotally coupled to the tray on opposite sides of the tray, and at least one elongated actuation rod operably coupled to the at least two arms, the at least two arms being configured to be reversibly coupled to opposite sides of the elongated expandable body; A chamber as described in Example 42, wherein, when the chamber is positioned within the body cavity, movement of a portion of the at least one elongate actuation rod located outside the body cavity moves the arms from a first state in which the arms are substantially aligned with the longitudinal axis of the tray to a second state in which the arms extend laterally from the plate while being reversibly coupled to both sides of the elongate expandable body, thereby expanding the elongate expandable body within the body cavity.

[0096] Example 47. The chamber of any one of Examples 36-46, wherein the chamber is suitable for implantation into a non-pneumoperitoneum body cavity.

[0097] Example 48. The chamber of Example 47, wherein the non-inflated body cavity includes a non-inflated abdominal cavity, and wherein in the collapsed state, the elongated expandable body is shaped and sized to penetrate an opening in the abdominal wall and reach the non-inflated abdominal cavity, and in the expanded state, the elongated expandable body is thin and has a surface area at least 5 times greater than the surface area of ​​the elongated expandable body in the collapsed state.

[0098] Example 49. The chamber of any one of Examples 36 to 48, wherein the fluid-permeable wall comprises at least one membrane layer having pores with sizes ranging from 0.1 μm to 100 μm.

[0099] Example 50. A fluid extraction chamber suitable for implantation into a body cavity, comprising: an expandable body configured to move from a collapsed state to an expanded state when deployed within the body lumen, the expandable body comprising a fluid permeable wall defining an interior volume of the expandable body; an outlet coupled to the expandable body, the outlet having at least one opening into the interior volume; The expandable body is formed from two portions of at least one porous membrane layer fixedly adhered to at least one mesh layer positioned therebetween to form a seam line around the circumference of the expandable body surrounding the internal volume.

[0100] Unless otherwise defined, all technical and / or scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of embodiments of the present invention, exemplary methods and / or materials are described below. In case of conflict, the present patent specification, including definitions, will control. Additionally, the materials, methods, and examples are merely illustrative and are not intended to be necessarily limiting.

[0101] As will be appreciated by those skilled in the art, some embodiments of the present invention may be embodied as a system, method, or computer program product. Accordingly, some embodiments of the present invention may take the form of an entirely hardware embodiment, an entirely software embodiment (including firmware, resident software, microcode, etc.), or an embodiment combining software and hardware aspects, all of which may be referred to generally herein as a "circuit," "module," or "system." Furthermore, some embodiments of the present invention may take the form of a computer program product embodied in one or more computer-readable medium(s) having computer-readable program code embodied thereon. Implementation of the method and / or system of some embodiments of the present invention may involve performing and / or completing selected tasks manually, automatically, or a combination thereof. Furthermore, depending on the actual instrumentation and apparatus of some embodiments of the method and / or system of the present invention, some selected tasks may be implemented by hardware, software, firmware, and / or a combination thereof, e.g., using an operating system.

[0102] For example, hardware for performing selected tasks according to some embodiments of the present invention may be implemented as a chip or circuit. As software, selected tasks according to some embodiments of the present invention may be implemented as a plurality of software instructions being executed by a computer using any suitable operating system. In exemplary embodiments of the present invention, one or more tasks according to some exemplary embodiments of the methods and / or systems as described herein are performed by a data processor, such as a computing platform for executing a plurality of instructions. Optionally, the data processor includes volatile memory for storing instructions and / or data, and / or non-volatile storage, e.g., a magnetic hard disk and / or removable media, for storing instructions and / or data. Optionally, a network connection is also provided. A display and / or a user input device, such as a keyboard or mouse, are also optionally provided.

[0103] Any combination of one or more computer-readable media may be utilized in some embodiments of the present invention. The computer-readable medium may be a computer-readable signal medium or a computer-readable storage medium. The computer-readable storage medium may be, for example, but not limited to, an electronic, magnetic, optical, electromagnetic, infrared, or semiconductor system, apparatus, or device, or any suitable combination of the foregoing. More specific examples (non-exhaustive list) of computer-readable storage media would include: an electrical connection having one or more wires, a portable computer diskette, a hard disk, a random access memory (RAM), a read-only memory (ROM), an erasable programmable read-only memory (EPROM or flash memory), an optical fiber, a portable compact disc read-only memory (CD-ROM), an optical storage device, a magnetic storage device, or any suitable combination of the foregoing. In the context of this specification, a computer-readable storage medium may be any tangible medium that contains or can store a program for use by or in connection with an instruction execution system, apparatus, or device.

[0104] A computer-readable signal medium may include a propagated data signal having computer-readable program code embodied therein, for example, in baseband or as part of a carrier wave. Such a propagated signal may take any of a variety of forms, including, but not limited to, electromagnetic, optical, or any suitable combination thereof. A computer-readable signal medium is not a computer-readable storage medium but can be any computer-readable medium that can communicate, propagate, or transport a program for use by or in connection with an instruction execution system, apparatus, or device.

[0105] The program code embodied on the computer readable medium and / or data used thereby may be transmitted using any suitable medium, including but not limited to wireless, wired, fiber optic cable, RF, etc., or any suitable combination of the foregoing.

[0106] Computer program code for carrying out operations for some embodiments of the present invention may be written in any combination of one or more programming languages, including object-oriented programming languages ​​such as Java, Smalltalk, C++, etc., and conventional procedural programming languages ​​such as the "C" programming language or similar programming languages. The program code may execute entirely on the user's computer, partially on the user's computer, as a standalone software package, partially on the user's computer, partially on a remote computer, or entirely on a remote computer or server. In the latter scenario, the remote computer may be connected to the user's computer through any type of network, including a local area network (LAN) or a wide area network (WAN), or may be connected to an external computer (e.g., through the Internet using an Internet Service Provider).

[0107] Some embodiments of the present invention may be described below with reference to flowchart illustrations and / or block diagrams of methods, apparatus (systems), and computer program products according to embodiments of the invention. It will be understood that each block of the flowchart illustrations and / or block diagrams, and combinations of blocks in the flowchart illustrations and / or block diagrams, can be implemented by computer program instructions. These computer program instructions are provided to a processor of a general-purpose computer, special-purpose computer, or other programmable data processing apparatus to produce machine-readable means for implementing the functions / acts specified in the flowchart illustrations and / or block diagram blocks.

[0108] These computer program instructions may also be stored on a computer-readable medium that can direct a computer, other programmable data processing apparatus, or other device to function in a particular manner, such that the instructions stored on the computer-readable medium create an article of manufacture including instructions that implement the functions / acts specified in the flowchart and / or block diagram blocks.

[0109] Computer program instructions may also be loaded into a computer, other programmable data processing apparatus, or other device and cause a series of operational steps to be executed on the computer, other programmable apparatus, or other device to generate a computer-implemented process, such that the instructions executing on the computer or other programmable apparatus provide a process for implementing the functions / operations specified in the flowchart and / or block diagram blocks.

[0110] Some of the methods described herein are generally designed to be used solely by a computer and may not be feasible or practical for purely manual execution by a human expert. A human expert who wished to manually perform similar tasks, such as determining pressure and / or changes therein and modifying pump operation, may be expected to use an entirely different method, e.g., utilizing specialized knowledge and / or the pattern recognition capabilities of the human brain, that would be far more efficient than performing the steps of the methods described herein manually. [Brief explanation of the drawings]

[0111] Some embodiments of the present invention are described herein, by way of example only, with reference to the accompanying drawings. Referring now specifically to the drawings in detail, it is emphasized that the details shown are by way of example and for the purpose of illustrative description of embodiments of the invention. In this regard, the description given in the drawings will make apparent to those skilled in the art how embodiments of the present invention may be practiced.

[0112] [Figure 1] 10 is a flowchart of a process for expanding an elongated fluid extraction chamber within a body cavity, according to some exemplary embodiments of the present invention. [Figure 2A] 1 is a block diagram of a fluid extraction system having an elongated fluid extraction chamber in a collapsed state, e.g., a collapsed state, according to some exemplary embodiments of the present invention. [Figure 2B] 1 is a block diagram of a fluid extraction system having an elongated fluid extraction chamber in an expanded, e.g., unfolded, state, according to some exemplary embodiments of the invention. [Figure 2C] 1 is a schematic diagram of a fluid extraction chamber in a collapsed state, according to some exemplary embodiments of the present invention; [Figure 2D] 1 is a schematic diagram of a fluid extraction chamber in an expanded state, according to some exemplary embodiments of the invention. [Figure 2E] 2D is a schematic cross-sectional view of FIG. 2C, according to some exemplary embodiments of the present invention. [Figure 2F] 2D, according to some exemplary embodiments of the present invention. [Figure 2G] Schematic diagrams showing the walls of a fluid extraction chamber, e.g., the membrane of the fluid extraction chamber, folded in different folding patterns, e.g., to obtain a folded, compact state of the fluid extraction chamber, according to some exemplary embodiments of the present invention. [Figure 2H] Schematic diagrams showing the walls of a fluid extraction chamber, e.g., the membrane of the fluid extraction chamber, folded in different folding patterns, e.g., to obtain a folded, compact state of the fluid extraction chamber, according to some exemplary embodiments of the present invention. [Figure 2I] Schematic diagrams showing the walls of a fluid extraction chamber, e.g., the membrane of the fluid extraction chamber, folded in different folding patterns, e.g., to obtain a folded, compact state of the fluid extraction chamber, according to some exemplary embodiments of the present invention. [Figure 2J]1 is a schematic illustration of a cross-sectional view of a fluid extraction chamber in an expanded state, according to some exemplary embodiments of the invention. [Figure 2K] 1 is a schematic illustration of a cross-sectional view of a fluid extraction chamber in an expanded state, according to some exemplary embodiments of the invention. [Figure 3A] 1 is a schematic diagram of a fluid extraction chamber in a collapsed state, according to some exemplary embodiments of the present invention; [Figure 3B] 1 is a schematic illustration of a fluid extraction chamber in a deployed state, according to some exemplary embodiments of the invention. [Figure 3C] 1A-1C are schematic illustrations of a chamber deployment process through two body orifices, according to some exemplary embodiments of the present invention. [Figure 3D] 1A-1C are schematic illustrations of a chamber deployment process through a single body orifice, according to some exemplary embodiments of the present invention. [Figure 3E] 10 is a flowchart of a process for chamber deployment through two body orifices, according to some exemplary embodiments of the present invention. [Figure 3F] 10 is a flowchart of a process for chamber deployment via a single body orifice, according to some exemplary embodiments of the present invention. [Figure 3G] 1A-1C are schematic illustrations of a chamber deployed within the abdominal cavity, according to some exemplary embodiments of the present invention. [Figure 4A] 10A-10C are schematic diagrams illustrating the expansion of a fluid extraction device using a two-state stylet, according to some exemplary embodiments of the present invention. [Figure 4B] 10A-10C are schematic diagrams illustrating the expansion of a fluid extraction device using a two-state stylet, according to some exemplary embodiments of the present invention. [Figure 4C] 10A-10C are schematic diagrams illustrating the expansion of a fluid extraction device using a two-state stylet, according to some exemplary embodiments of the present invention. [Figure 4D] 1 is a schematic illustration of a wall of a fluid extraction device, according to some exemplary embodiments of the present invention; [Figure 4E]1 is a schematic illustration of a wall of a fluid extraction device, according to some exemplary embodiments of the present invention; [Figure 4F] 1A-1C are schematic illustrations of types of perforated layers in the walls of fluid extraction devices, according to some exemplary embodiments of the present invention. [Figure 4G] 1A-1C are schematic illustrations of types of perforated layers in the walls of fluid extraction devices, according to some exemplary embodiments of the present invention. [Figure 4H] 1A-1C are schematic illustrations of types of perforated layers in the walls of fluid extraction devices, according to some exemplary embodiments of the present invention. [Figure 5A] 1 is a schematic diagram illustrating a fluid extraction chamber having an inner hydrophobic portion in a folded state, according to some exemplary embodiments of the present invention. [Figure 5B] 1A-1C are schematic diagrams illustrating a fluid extraction chamber having an inner hydrophobic portion in an expanded state, according to some exemplary embodiments of the present invention. [Figure 5C] 1 is a schematic diagram of a perforated tube, according to some exemplary embodiments of the present invention. [Figure 5D] 3A-3C are schematic illustrations of wall layers of a fluid extraction chamber, according to some exemplary embodiments of the invention; [Figure 5E] 3A-3C are schematic illustrations of wall layers of a fluid extraction chamber, according to some exemplary embodiments of the invention; [Figure 6A] 1A-1C are schematic diagrams illustrating a fluid extraction chamber with an integrated stylet, according to some exemplary embodiments of the present invention. [Figure 6B] 1A-1C are schematic diagrams illustrating a fluid extraction chamber with an integrated stylet, according to some exemplary embodiments of the present invention. [Figure 7] 1A-1C are schematic diagrams of expandable body opening seals, according to some exemplary embodiments of the present invention. [Figure 8A] 1 is a schematic diagram of a fluid extraction chamber having walls with two or more filtration phases, according to some exemplary embodiments of the present invention. [Figure 8B]1 is a schematic diagram of a fluid extraction chamber having walls with two or more filtration phases, according to some exemplary embodiments of the present invention. [Figure 8C] 1 is a schematic diagram of a fluid extraction chamber having walls with two or more filtration phases, according to some exemplary embodiments of the present invention. [Figure 9A] 1A-1C are schematic diagrams of an access tube for an intraluminal device having at least one additional flow path into the lumen, according to some exemplary embodiments of the present invention. [Figure 9B] 1A-1C are schematic diagrams of an access tube for an intraluminal device having at least one additional flow path into the lumen, according to some exemplary embodiments of the present invention. [Figure 9C] 1A-1C are schematic diagrams of an access tube for an intraluminal device having at least one additional flow path into the lumen, according to some exemplary embodiments of the present invention. [Figure 10A] 10A-10C are schematic diagrams illustrating the release of material-absorbing beads into the internal lumen of a fluid extraction chamber, according to some exemplary embodiments of the present invention. [Figure 10B] 10A-10C are schematic diagrams illustrating the release of material-absorbing beads into the internal lumen of a fluid extraction chamber, according to some exemplary embodiments of the present invention. [Figure 10C] 1 is a schematic diagram of a cross section of a fluid extraction chamber, according to some exemplary embodiments of the invention; [Figure 10D] A schematic diagram of a cross section made in a fluid extraction chamber showing two portions of at least one membrane layer welded together through an intermediate porous layer along at least one seam line at the circumference of the chamber body surrounding the internal volume of the chamber, according to some exemplary embodiments of the present invention. [Figure 11A] 1A-1C are schematic diagrams illustrating fluid extraction chambers with insertable flexible scaffolds, according to some exemplary embodiments of the present invention. [Figure 11B] 1A-1C are schematic diagrams illustrating fluid extraction chambers with insertable flexible scaffolds, according to some exemplary embodiments of the present invention. [Figure 11C]1A-1C are schematic diagrams illustrating fluid extraction chambers with insertable flexible scaffolds, according to some exemplary embodiments of the present invention. [Figure 11D] 1A-1C are schematic diagrams illustrating fluid extraction chambers with insertable flexible scaffolds, according to some exemplary embodiments of the present invention. [Figure 12A] 1A-1C are schematic diagrams illustrating fluid extraction chambers with integrated flexible scaffolding, according to some exemplary embodiments of the present invention. [Figure 12B] 1A-1C are schematic diagrams illustrating fluid extraction chambers with integrated flexible scaffolding, according to some exemplary embodiments of the present invention. [Figure 13A] 1A-1C are schematic diagrams illustrating a fluid extraction chamber with an integrated flexible scaffold including at least two flexible stylets, optionally independent stylets, according to some exemplary embodiments of the present invention. [Figure 13B] 13B is a schematic diagram showing the fluid extraction chamber of FIG. 13A when the pressure exerted on the fluid extraction chamber by an organ or tissue is resisted by allowing the outer stylet to bend while the inner stylet keeps the internal volume of the chamber open, according to some exemplary embodiments of the present invention. [Figure 14A] 1A-1C are schematic diagrams illustrating the expansion of a fluid extraction chamber with an internal scaffold using external bars reversibly coupled to the internal scaffold, according to some exemplary embodiments of the present invention. [Figure 14B] 1A-1C are schematic diagrams illustrating the expansion of a fluid extraction chamber with an internal scaffold using external bars reversibly coupled to the internal scaffold, according to some exemplary embodiments of the present invention. [Figure 14C] 1A-1C are schematic diagrams illustrating the expansion of a fluid extraction chamber with an internal scaffold using external bars reversibly coupled to the internal scaffold, according to some exemplary embodiments of the present invention. [Figure 14D] 10A-10C are schematic diagrams illustrating the decoupling of the outer bars from the inner scaffolding of the fluid extraction chamber after expansion of the chamber, according to some exemplary embodiments of the invention. [Figure 14E]10A-10C are schematic diagrams illustrating the decoupling of the outer bars from the inner scaffolding of the fluid extraction chamber after expansion of the chamber, according to some exemplary embodiments of the invention. [Figure 14F] 10A-10C are schematic diagrams illustrating the decoupling of the outer bars from the inner scaffolding of the fluid extraction chamber after expansion of the chamber, according to some exemplary embodiments of the invention. [Figure 14G] 10A-10C are schematic diagrams illustrating the decoupling of the outer bars from the inner scaffolding of the fluid extraction chamber after expansion of the chamber, according to some exemplary embodiments of the invention. [Figure 15A] Schematic diagram showing the expansion of a fluid extraction chamber with an inner scaffold using at least two external bars having distal ends positioned within the internal lumen of the fluid extraction chamber and proximal ends outside the internal lumen, according to some exemplary embodiments of the present invention. [Figure 15B] Schematic diagram showing the expansion of a fluid extraction chamber with an inner scaffold using at least two external bars having distal ends positioned within the internal lumen of the fluid extraction chamber and proximal ends outside the internal lumen, according to some exemplary embodiments of the present invention. [Figure 15C] Schematic diagram showing the expansion of a fluid extraction chamber with an inner scaffold using at least two external bars having distal ends positioned within the internal lumen of the fluid extraction chamber and proximal ends outside the internal lumen, according to some exemplary embodiments of the present invention. [Figure 16A] 1A-1C are schematic diagrams illustrating the expansion of a fluid extraction chamber with an internal scaffold using at least two external bars operatively coupled to the outer surface of the fluid extraction chamber, according to some exemplary embodiments of the present invention. [Figure 16B] 1A-1C are schematic diagrams illustrating the expansion of a fluid extraction chamber with an internal scaffold using at least two external bars operatively coupled to the outer surface of the fluid extraction chamber, according to some exemplary embodiments of the present invention. [Figure 16C] 1A-1C are schematic diagrams illustrating the expansion of a fluid extraction chamber with an internal scaffold using at least two external bars operatively coupled to the outer surface of the fluid extraction chamber, according to some exemplary embodiments of the present invention. [Figure 17A] 10A-10C are schematic diagrams illustrating the expansion of a fluid extraction chamber having an internal scaffold using an expansion tool including an expansion tray, according to some exemplary embodiments of the present invention. [Figure 17B] 10A-10C are schematic diagrams illustrating the expansion of a fluid extraction chamber having an internal scaffold using an expansion tool including an expansion tray, according to some exemplary embodiments of the present invention. [Figure 17C] 10A-10C are schematic diagrams illustrating the expansion of a fluid extraction chamber having an internal scaffold using an expansion tool including an expansion tray, according to some exemplary embodiments of the present invention. [Figure 17D] 17A-17C, according to some exemplary embodiments of the present invention. FIG. 17B is a schematic diagram illustrating a mechanism for moving the arms of the expansion tray shown in FIGS. [Figure 17E] 17A-17C, according to some exemplary embodiments of the present invention. FIG. 17B is a schematic diagram illustrating a mechanism for moving the arms of the expansion tray shown in FIGS. [Figure 18] 10 is a flowchart of a process for deploying a fluid extraction chamber within a body cavity using an expansion tool, according to some exemplary embodiments of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0113] The present invention, in some embodiments thereof, relates to ultrafiltration devices and methods, and more particularly, but not exclusively, to percutaneously implantable ultrafiltration devices and methods.

[0114] One aspect of some embodiments relates to an elongated fluid extraction device, e.g., a chamber, that can be introduced into a non-pneumoperitoneal body cavity through a small body opening and expanded within the non-pneumoperitoneal body cavity. In some embodiments, the body of the elongated fluid extraction device, when inserted into the non-pneumoperitoneal body cavity through a body opening and / or expanded within the non-pneumoperitoneal body cavity, has a length-to-width ratio of at least 2:1, e.g., at least 2.5:1, 3:1, 4:1, 5:1, 10:1, or any intermediate, smaller, or larger ratio. In some embodiments, the outlet of the elongated fluid extraction device remains outside the body, optionally coupled to a vacuum generator, e.g., a pump, and / or to a reservoir located outside the body. In some embodiments, the fluid extraction chamber is introduced into the non-pneumoperitoneal body cavity under local anesthesia.

[0115] According to some embodiments, when expanded within a body cavity, for example a non-pneumoperitoneum body cavity, the elongated fluid extraction device is used to remove fluid found within the body cavity using filtration, for example ultrafiltration. In some embodiments, fluid within the body cavity enters the internal lumen of the fluid extraction device through the pores and is removed from the patient's body through the outlet. In some embodiments, fluid is removed from the body cavity when a vacuum is applied to the internal volume of the device, leading to the suction of body cavity fluid into the internal volume.

[0116] According to some embodiments, when expanded within a body cavity, the body of the elongate fluid extraction device bridges two spaced apart regions, e.g., the ends of the body cavity, that are located at a distance of at least 5 cm from each other. In some embodiments, in the expanded state, the body of the elongate fluid extraction device has a length of at least 5 cm, at least 10 cm, at least 15 cm, at least 20, at least 25 cm, or any intermediate, smaller, or larger value. In some embodiments, the body is configured to expand laterally within the body cavity. Optionally, the lateral expansion of the body increases the width of the body by at least 2-fold, at least 3-fold, at least 4-fold, or any intermediate, smaller, or larger value, relative to the width of the body in its collapsed state when introduced into the body cavity through the opening. Optionally, when the body expands laterally within the body cavity, the length of the body changes by less than 1.5, e.g., less than 1.4, less than 1.2, or any intermediate, smaller, or larger value, relative to the length of the body when the device is in its collapsed state.

[0117] According to some embodiments, the elongated fluid extraction chamber is expanded within a body cavity by insertion of a stylet, e.g., an expandable stylet, into the interior volume of the chamber from outside the body. Alternatively or additionally, the chamber is expanded by expanding a stylet integrated with the chamber. Alternatively or additionally, the chamber is expanded by injection of a fluid into the interior volume of the chamber. In some embodiments, the stylet is shaped as a wire having a thickness of less than 1.5 mm, e.g., less than 1.2 mm, less than 1 mm, or any intermediate, smaller, or larger value.

[0118] According to some embodiments, the fluid extraction chamber is introduced into a body cavity during a surgical procedure, e.g., laparoscopic surgery, performed under local or regional anesthesia. In some embodiments, the opening formed in the body has a maximum width in the range of 1.5 mm to 12 mm, e.g., 1.5 mm to 5 mm, 3 mm to 7 mm, 5 mm to 10 mm, or any intermediate, smaller, or larger range. In some embodiments, the elongated fluid extraction chamber in its collapsed state is shaped and sized to fit within the formed opening. In some embodiments, the maximum width of the chamber in its collapsed state is in the range of 1.5 mm to 14 mm, e.g., 1.5 mm to 5 mm, 3 mm to 7 mm, 5 mm to 10 mm, or any intermediate, smaller, or larger range.

[0119] A potential advantage of having an elongated, expandable fluid extraction chamber for removing fluid may be that it allows for a large surface area while maintaining a low profile of the chamber in the collapsed state when the device expands within the body cavity for fluid filtration and removal.

[0120] An additional possibility of having an elongated fluid extraction chamber for removing fluid may be to allow fluid removal from spaced regions of the body cavity.

[0121] An aspect of some embodiments relates to a fluid extraction chamber having two or more types of pores configured to open under different pressure thresholds, in some embodiments, at least one type of pore is configured to open when the pressure level within the internal volume of the fluid extraction chamber is higher than the pressure threshold required to open the different types of pores of the device.

[0122] According to some embodiments, the two or more types of pores are located in different regions of the chamber, for example, on opposite sides. Alternatively or additionally, the two or more types of pores are located on the same side of the chamber. In some embodiments, each type of pore is located in a different membrane or layer of the chamber wall.

[0123] A potential advantage of having two types of pores may be that it allows for continuous fluid filtration even if one type of pore becomes clogged.

[0124] One aspect of some embodiments relates to removing molecules, such as toxins, from fluids in a body cavity using particles, e.g., beads, introduced into the internal lumen of a fluid extraction chamber. In some embodiments, the beads are located within the internal lumen of the chamber upon deployment or are introduced into the internal lumen of an already deployed chamber after deployment. In some embodiments, the beads are introduced into the internal lumen of the chamber upon indication of an increased concentration of one or more toxins in the body cavity fluid.

[0125] According to some embodiments, the beads are removed from the interior volume of the chamber through an outlet of the chamber, for example using suction. Optionally, after removal of the beads, the beads are replaced with new beads. Alternatively, the beads remain in the interior volume of the chamber and are removed from the body cavity upon removal of the chamber.

[0126] One aspect of some embodiments relates to the expansion of a collapsed fluid extraction chamber having a fluid-permeable wall defining an interior volume within a body cavity by temporarily sealing the fluid-permeable wall and introducing, e.g., injecting, a fluid into the interior volume. In some embodiments, the fluid-permeable wall is sealed with a degradable, also referred to herein as resorbable, material, e.g., a biodegradable material. In some embodiments, the biodegradable material is applied to an outer surface of the fluid-permeable wall as a coating, e.g., a hydrophobic coating. Alternatively or additionally, the biodegradable material is applied to an inner surface of the fluid-permeable wall as a coating, e.g., a hydrophobic coating.

[0127] According to some embodiments, injection of a fluid into the interior volume degrades the coating, hi some embodiments, the sealing coating degrades by hydrolysis.

[0128] An aspect of some embodiments relates to treating a patient diagnosed with heart failure, e.g., chronic or acute heart failure, by introducing a fluid extraction chamber into a non-pneumoperitoneal peritoneal cavity. In some embodiments, the fluid extraction chamber is introduced into the non-pneumoperitoneal peritoneal cavity under local anesthesia. Optionally, fluid accumulation within the patient's peritoneal cavity is detected prior to introduction of the fluid extraction chamber. In some embodiments, the fluid extraction chamber comprises a fluid-permeable wall defining an interior volume. In some embodiments, application of negative pressure to the interior volume, optionally intermittently, draws fluid from the peritoneal cavity into the interior volume of the chamber. In some embodiments, fluid drawn into the interior volume of the chamber is removed from the patient's body via an outlet tube fluidly coupled to the interior volume.

[0129] An aspect of some embodiments relates to expanding a fluid extraction chamber within a body cavity, such as the abdominal cavity, using an elongated expansion tool, e.g., a expander, coupled to the chamber. In some embodiments, the tool is manipulated, e.g., axially moved and / or rotated, from outside the body cavity, e.g., from outside the subject. Optionally, the tool is configured to be reversibly coupled to and decoupled from the chamber and removed from the body cavity.

[0130] According to some embodiments, the elongate expansion tool is operably coupled to the outer surface of the chamber body. Alternatively or additionally, the elongate expansion tool is positioned within the interior volume, for example, the interior lumen of the chamber. In some embodiments, the elongate expansion tool is inserted into the interior volume via at least one outlet of the chamber. In some embodiments, the elongate expansion tool is optionally reversibly coupled to the inner scaffold within the interior volume. In some embodiments, the elongate expansion tool is configured to move the inner scaffold from the collapsed state to the expanded state by applying a force to the inner scaffold, for example, by axially translating and / or rotating the elongate expansion tool.

[0131] One aspect of some embodiments relates to forming the fluid extraction chamber body by adhering, e.g., by fixedly adhering, two portions of at least one membrane layer to at least one intermediate layer positioned therebetween, the two portions together. In some embodiments, adhering the two portions comprises welding and / or gluing the two portions to the intermediate layer, e.g., on either side of the intermediate layer.

[0132] According to some embodiments, the fixed bonding of the two membrane portions is formed along and / or along at least one seam line of the circumference of the chamber that surrounds the interior volume of the chamber. In some embodiments, the at least one intermediate layer is a porous layer, for example, to not impede fluid flow through the membrane into the chamber. Optionally, the at least one intermediate layer is a mesh layer. Optionally, the two portions of the at least one membrane layer are bonded to each other via the intermediate layer, for example, via pores in the intermediate layer. In some embodiments, bonding the two portions includes bonding two separate membrane layers to at least one intermediate layer positioned therebetween to form an enclosed body of the chamber having at least one outlet.

[0133] Before describing at least one embodiment of the present invention in detail, it is to be understood that the invention is not necessarily limited in its application to the details and arrangements of components and / or methods set forth in the following description and / or illustrated in the drawings and / or examples. The invention is capable of other embodiments or of being practiced or carried out in various ways.

[0134] A common process for extracting fluid from a body cavity According to some exemplary embodiments, a fluid extraction chamber is inserted into a body cavity of a subject, e.g., a patient, having excess fluid therein. In some embodiments, the excess fluid is the result of a clinical condition associated with a disease, e.g., heart failure, kidney disease, nephrotic syndrome, liver cirrhosis, or cancer. Alternatively or additionally, the excess fluid is the result, e.g., a side effect, of a treatment administered to the patient, e.g., excessive diuretics, which may lead to further kidney deterioration or certain discectomies. In some embodiments, the fluid insertion chamber is introduced into the body cavity through a small incision made in the body under local anesthesia. In some embodiments, the size of the incision made in the patient's body is between 3 mm and 15 mm, e.g., between 3 mm and 7 mm, between 5 mm and 10 mm, between 5 mm and 15 mm, or any intermediate, smaller, or larger range. Optionally, the body incision is further expanded to a width value within the range of 6 mm to 30 mm, such as 6 mm to 12 mm, 10 mm to 17 mm, 13 mm to 20 mm, 17 mm to 30 mm, or any intermediate, smaller, or larger range value.

[0135] According to some exemplary embodiments, the extraction chamber is part of a system for filtering fluids in or through a body cavity, e.g., ultrafiltration. As used herein, ultrafiltration means drawing a fluid through at least one body membrane and filtering it through at least one semipermeable membrane under a hydrostatic pressure or concentration (osmotic / tumor) gradient. In some embodiments, the outlet of the chamber extends outside the patient's body, e.g., through an incision used to introduce the chamber into the body cavity.

[0136] According to some exemplary embodiments, the fluid extraction chamber remains within the body cavity with the outlet outside the body for a period ranging from 1 hour to 2 months, e.g., 1 hour to 48 hours, 1 day to 1 week, 1 day to 5 days, 5 days to 2 weeks, 1 week to 3 weeks, or any intermediate, shorter, or longer period. In some embodiments, the fluid extraction chamber is removed from the body cavity and optionally replaced when the fluid level within the body cavity falls below a predetermined value. Alternatively or additionally, the fluid extraction chamber is removed from the body cavity and optionally replaced when the filtration efficiency falls below a predetermined value. Alternatively, the fluid extraction chamber is implanted within the patient's body with the chamber's outlet and optionally a pump configured to generate and apply a negative pressure to the interior volume of the fluid extraction chamber.

[0137] According to some exemplary embodiments, the fluid extraction chamber is part of a fluid extraction system that includes the chamber, pump, and control unit can be fully implantable, for example, in a chronic patient, such as a patient with chronic heart failure. Alternatively, the system can be partially implanted, for example, with the pump and control unit located outside the patient's body, for example, in a patient diagnosed with acute heart failure. In some embodiments, in a partially implantable configuration, the chamber is inside the body and the pump and / or the outlet of the chamber are located outside the patient's body. In some embodiments, only the chamber is implanted, and the pump, control unit, and outlet of the chamber are located outside the patient's body, such as in the case of cancer patients and / or patients with chronic kidney disease.

[0138] Reference is now made to FIG. 1, which illustrates filtering fluid from a body cavity, according to some exemplary embodiments of the present invention.

[0139] According to some exemplary embodiments, excess systemic fluid is identified systemically, optionally locally within the body or in a particular cavity, such as the pleural cavity of the subject, at block 102. In some embodiments, the fluid is identified using an imaging system, such as an x-ray or ultrasound imaging system. Alternatively, fluid overload is identified by physical and / or biochemical testing of the patient.

[0140] According to some exemplary embodiments, the patient is locally anesthetized at block 102. In some embodiments, local anesthesia is delivered to the patient near or at a selected location to create an opening in the abdominal wall suitable for insertion of a fluid extraction chamber into the patient's abdominal cavity.

[0141] According to some exemplary embodiments, an opening is formed in the abdominal cavity at block 106. In some embodiments, the opening is formed by forming an incision through the abdominal wall. In some embodiments, the length of the incision is in the range of 3 mm to 15 mm, e.g., in the range of 3 mm to 8 mm, in the range of 3 mm to 8 mm, in the range of 8 mm to 15 mm, or any intermediate, smaller, or larger range of values. Optionally, the opening is formed prior to laparoscopic surgery.

[0142] According to some exemplary embodiments, the elongated extraction chamber is introduced into the body cavity in a collapsed state at block 108. In some embodiments, the elongated extraction chamber is introduced through the opening formed at block 106. In some embodiments, the flow path, e.g., channel, including the outlet of the extraction chamber remains outside the patient's body. In some embodiments, the elongated extraction chamber is rigid axially, e.g., in the direction of the long axis of the chamber, during insertion. In some embodiments, the rigidity can, for example, optionally assist the insertion process through a small incision without bending the chamber. In some embodiments, the chamber is rigid by placing a sleeve, e.g., a jacket, optionally a rigid sleeve, around the chamber body in the collapsed state.

[0143] According to some exemplary embodiments, at block 110, once the chamber is within the abdominal cavity, the chamber is expanded to attain an expanded state. In some embodiments, the chamber is expanded by introducing a stylet from outside the body into the interior volume of the chamber. Alternatively, the chamber is expanded by expanding a stylet, for example, a bi-state stylet having a collapsed state and an expanded state, within the interior lumen of the chamber. Optionally, the expandable stylet is integrated into the body of the chamber. Optionally, the chamber expands upon dissolution of a dissolvable sleeve, for example, a dissolvable jacket, within the body cavity. In some embodiments, dissolution of the jacket, which optionally applies force to the expandable stylet, results in expansion of the stylet.

[0144] According to some exemplary embodiments, the chamber is expanded by introducing a fluid from outside the body into the internal lumen of the chamber, hi some embodiments, a hydrophobic core, e.g., a hydrophobic inner layer of the chamber wall, causes the chamber to expand when fluid is introduced into the internal lumen.

[0145] According to some exemplary embodiments, the bodily fluid is filtered at block 112. In some embodiments, a vacuum is applied to the interior volume of the chamber to cause fluid to enter the interior volume of the chamber from the body cavity through pores in the wall of the chamber. In some embodiments, suction created by the applied vacuum force extracts the fluid from the interior volume of the chamber through at least one outlet of the chamber, optionally outside the patient's body.

[0146] According to some exemplary embodiments, filtering at block 112 is performed until the pores of the chamber become clogged, leading to an increase in the applied vacuum force and / or a decrease in fluid flow through the chamber outlet. Optionally, during filtering at block 112, when the applied vacuum force is higher than a threshold level, at least one additional set of pores is opened to increase fluid flow through the outlet and, optionally, decrease the applied vacuum force.

[0147] According to some exemplary embodiments, optionally, an elongated chamber filters fluid from two spaced apart regions within the body cavity at block 114. Optionally, the elongated chamber spans between the two spaced apart regions of the body cavity.

[0148] According to some exemplary embodiments, once filtration has stopped, the device is optionally removed from the body at block 118. In some embodiments, the device is removed by removing the internal reinforcing diffusion stylet and removing the loosened device from a given cavity, optionally using the exit tube as a service channel. Alternatively, a pre-inflated locking balloon is deflated to allow the entire device to be removed. Alternatively, the mechanical state of the diffusion stylet is altered by releasing it from its buckled position or by using cold air injection to reduce the stiffness of the device framework or diffusion stylet. In some embodiments, the device is removed when the amount of fluid in the body cavity is below a predetermined value and / or when the pores of the device become clogged and filtration is inefficient. Optionally, the device is replaced with a new device to continue filtration as needed.

[0149] According to some exemplary embodiments, a system including the device is implanted at block 116. In some embodiments, the system including the device and at least one pump is optionally implanted when there is a chronic need for fluid removal, e.g., for a period of more than one week, e.g., more than two weeks, more than three weeks, more than one month, or any intermediate, shorter, or longer period.

[0150] Exemplary Fluid Extraction Chambers and Systems According to some exemplary embodiments, the fluid extraction chamber is used to extract fluid from a body cavity, in some embodiments, the extracted fluid comprises one or more molecules that enter the interior lumen of the chamber through the pores of the fluid extraction chamber and exit the body.

[0151] Reference is now made to Figures 2A and 2B, which illustrate a fluid extraction chamber and a fluid extraction system, respectively, according to some exemplary embodiments of the present invention.

[0152] According to some exemplary embodiments, the fluid extraction chamber 202 comprises an elongate body 204 having an interior volume 206 defined by walls 208 of the elongate body 204. In some embodiments, the walls 208 include one or more layers of membranes having one or more types of pores. In some embodiments, the one or more pore types have sizes ranging from 0.1 μm (micron) to 0.5 μm, 0.5 μm to 10 μm, or 10 μm to 100 μm for small, medium, or large ranges, respectively. Optionally, the walls 208 include two or more types of membranes, each having pores of different sizes, for example, a first type of pores having sizes ranging from 0.1 μm to 0.5 μm and a second type of pores having sizes ranging from 0.5 μm to 10 μm or 10 μm to 100 μm. Alternatively, the membranes can be hydrogel-type or biologically based, for example, collagen. In some embodiments, the outer layer promotes tissue embedding and revascularization thereon, while the inner layer maintains tissue impermeability. Alternatively, each membrane can be positioned in a different portion of the wall to allow for different fluid filtration rates. Optionally, each membrane can be individually actuated to accommodate various physiological conditions. In some embodiments, each membrane is constructed with the same porosity range but features different structures or hydrophilicities.

[0153] According to some exemplary embodiments, one or more layers of the wall, e.g., a membrane layer on the outer surface of the body, allow cell and tissue growth on the outer surface of the chamber, hi some embodiments, one or more inner layers of the wall, e.g., a layer facing the interior volume, prevent tissue and cell growth and / or penetration into the interior volume.

[0154] According to some exemplary embodiments, chamber 202 includes at least one outlet 210, optionally a single outlet, from interior volume 206. In some embodiments, outlet 210 includes at least one flow path, e.g., at least one channel. In some embodiments, when the chamber is deployed within a body cavity, a vacuum is applied via outlet 210 on interior volume 206, creating a negative pressure within interior volume 206, causing fluid to be drawn from the body cavity through pores in wall 2087 into interior volume 206 and out of the body via outlet 210.

[0155] According to some exemplary embodiments, chamber 202 optionally comprises a stylet 212, optionally a resilient stylet, within interior volume 206 or at least partially attached to the inner surface of wall 208. In some embodiments, stylet 212 is configured to move between a collapsed state and an expanded state. In some embodiments, in the expanded state, stylet 212 presses against the inner surface of wall 208, causing expansion of body 204. In some embodiments, stylet 212 is integral to body 204. Alternatively, stylet 212 is insertable into interior volume 216 or wall 208, for example, within a circumferential channel in wall 208, from outside the patient's body, optionally through outlet 210.

[0156] According to some exemplary embodiments, when expanded, the stylet 212 is configured to expand the body 204 to assume any shape, e.g., a polygonal, diamond, or triangular shape, optionally according to the shape of the stylet 212 in its expanded state. In some embodiments, the stylet is preformed to assume a particular shape upon expansion, for example, if the stylet is a two-state stylet configured to move from a collapsed, compact, elongated shape to a preformed shape upon expansion. Optionally, the stylet 212, e.g., a one-piece stylet, is formed from a shape memory alloy, e.g., nitinol.

[0157] 2A , in the collapsed state, body 204 is disposed within a sheet, e.g., jacket 214. In some embodiments, jacket 214 is configured to maintain body 204 in the collapsed state, e.g., folded state, optionally by applying a mechanical force to an outer layer of wall 208 in a direction toward the center of interior volume 206. Optionally, the applied force is equal to or greater than the force applied by stylet 212 against the inner surface of wall 208.

[0158] 2A, the body 204 is elongated having a major axis 216 and a minor axis 218. In some embodiments, in the collapsed state, the length 220 of the body 204 is between 10 cm and 28 cm, e.g., between 10 cm and 20 cm, between 15 cm and 25 cm, between 17 cm and 28 cm, or any intermediate, smaller, or larger range of values. In some embodiments, in the collapsed state, the maximum width 222 of the body 204, optionally the minor axis of the body, is between 6 mm and 15 mm, e.g., between 6 mm and 10 mm, between 8 mm and 12 mm, between 10 mm and 15 mm, or any intermediate, smaller, or larger range of values.

[0159] According to some exemplary embodiments, in the expanded state, for example, as shown in FIG. 2B , body 204 optionally expands laterally. In some embodiments, the expansion of body 204 increases maximum width 222. In some embodiments, in the expanded state, maximum width 222 is in the range of 5 cm to 20 cm, e.g., 8 cm to 16 cm, 5 cm to 15 cm, 10 cm to 20 cm, or any intermediate, smaller, or larger range. In some embodiments, in the expanded state, maximum width 222 increases by at least 1.5 times, e.g., at least 2 times, at least 2.5 times, at least 3 times, at least 5 times, at least 10 times, or any intermediate, smaller, or larger increase ratio, compared to maximum width 222 when the body is collapsed. Optionally, in the expanded state, length 220 changes by a ratio of 1 to 1.5 compared to length 220 in the collapsed state.

[0160] According to some exemplary embodiments, after expansion, body 202 has an aspect ratio length-to-width value in the range of 1.2:1 to 10:1, e.g., 1.2:1 to 2:1, 1.5:1 to 3:1, 2:1 to 5:1, 4:1 to 10:1, or any intermediate, smaller, or larger value. In some embodiments, the ratio between the width and length of the body in the expanded state is at least 1:1.2, e.g., at least 1:1.4, at least 1:1.8, at least 1:2, or any intermediate, smaller, or larger value. In some embodiments, the thickness, optionally the minimum thickness of body 202 in the expanded state, e.g., thickness 261 shown in FIG. 2F , is less than 5 mm, e.g., less than 4 mm, less than 3 mm, less than 2 mm, less than 1 mm, or any intermediate, smaller, or larger value.

[0161] According to some exemplary embodiments, the body 204 expands, for example, when the stylet 212 moves to the expanded state, pressing against the inner surface of the wall 208. In some embodiments, the body 204 expands when the jacket 214 is dissolved, for example, by fluid within the body cavity.

[0162] According to some exemplary embodiments, body 204 expands when fluid is introduced into interior volume 206 via outlet 210, causing body 204 to expand. Optionally, at least one interior layer of wall 208 facing interior volume 206 is coated with or includes a hydrophobic material, optionally a biodegradable hydrophobic material, such as polylactic acid (PLA, PDLA, PLLA), polyglycolide (PLGA), polyglycerol sebacate (PGS), or a soluble glucose / glycogen-based coating. In some embodiments, when fluid is introduced into interior volume 206, two opposing hydrophobic portions of the wall repel the introduced fluid, causing body 204 to expand outward, away from the fluid in the interior volume. Alternatively, expansion of 204 is achieved by injecting fluid at a high flow rate through 210 that exceeds the flow rate of wall 208, causing body 204 to expand into its preformed or scaffold-supported configuration.

[0163] Alternatively or additionally, if the chamber 202 does not include an integrated stylet 212, the stylet is forced into the interior volume 206 via at least one flow passage in the outlet 210, leading to expansion of the body 204. In some embodiments, the body 204 expands by unfolding or opening a membrane that forms the body 204, e.g., the body wall 208. In some embodiments, the body 204 or the chamber 202 includes a stylet lock 205 configured to lock the stylet in a fixed state when the body 204 is in the expanded state.

[0164] According to some exemplary embodiments, chamber 202 comprises a resilient support structure 213, e.g., an elastic skeleton, which is optionally porous within the interior volume 208 of the chamber. In some embodiments, the support structure comprises a mesh or sponge and is configured to contact the interior surface of wall 208. In some embodiments, when body 206 is in the expanded state, support structure 213 is compressed, and when body 206 is in the expanded state, support structure 213 is expanded. In some embodiments, during actuation of the chamber and after deployment of chamber 202, support structure 213 is configured to maintain body 202 along at least 30% of the length 220 of body 204, e.g., along at least 50% of the body length, along at least 60% of the body length, along at least 80% of the body length, or any intermediate, lesser, or greater percentage value, e.g., by preventing wall 208 from collapsing onto interior volume 206.

[0165] According to some exemplary embodiments, the support structure fills at least 30% of the interior volume 216 of the body 204, e.g., at least 50% of the interior volume 216, at least 60% of the interior volume, at least 70% of the interior volume, at least 80% of the interior volume, at least 90% of the interior volume, or any intermediate, smaller, or greater percentage of the interior volume.

[0166] According to some exemplary embodiments, support structure 213 is at least partially rigid, for example, to provide mechanical support to wall 208. In some embodiments, the pores of support structure 213 have similar sizes or variable sizes. In some embodiments, the pores are evenly or randomly distributed within support structure 213. In some embodiments, support structure 213 includes one or more layers of material having a mesh, web, or sponge structure. Optionally, at least a portion of the support structure includes support structures and / or support materials configured to allow expansion of support structure 213 when the support structure is stretched.

[0167] According to some exemplary embodiments, in a collapsed state, e.g., a folded state, and in an expanded state, e.g., an unfolded or open state, the elongate body 204 has a tubular, e.g., cylindrical, elongate shape.

[0168] According to some exemplary embodiments, in the expanded state, the wall 208, including the membrane, is flat, optionally substantially flat, e.g., along at least 80%, at least 85%, at least 90%, or at least 95% of the length of the wall 208. In some embodiments, in the expanded state, the body 204 is thin, having a maximum thickness of less than 5 mm, e.g., less than 4 mm, less than 3 mm, less than 2 mm, less than 1 mm, or any intermediate, smaller, or larger value. In some embodiments, when the body 204 is expanded, the surface area of ​​the outer surface of the wall increases by at least 5 times, e.g., at least 10 times, at least 20 times, at least 50 times, or any intermediate, smaller, or larger value, compared to the surface area of ​​the outer surface of the wall when the body 204 is in the collapsed state. In some embodiments, in the expanded state, the surface area of ​​the wall facing the abdominal cavity is at least 200 cm, e.g., at least 300 cm, at least 400 cm, at least 500 cm, or any intermediate, smaller, or larger value.

[0169] 2B, a system for fluid extraction, e.g., system 223, comprises chamber 202 and a control unit 225. In some embodiments, control unit 225 comprises a vacuum generator, e.g., pump 224, coupled to outlet 210 and configured to apply a vacuum, e.g., negative pressure, to interior volume 206, e.g., via outlet 210, e.g., via at least one channel within outlet 210.

[0170] According to some exemplary embodiments, control unit 225 comprises a memory 226 that stores at least one operating protocol of the pump and / or one or more parameter values ​​of the applied vacuum, e.g., the timing of applying vacuum to interior volume 206 by pump 224 and the applied vacuum level. In some embodiments, control unit 225 optionally comprises control circuitry 228 configured to control operation of the pump based on the at least one operating protocol and / or parameter values ​​stored in memory 226.

[0171] According to some demonstrative embodiments, the control unit 225 comprises at least one sensor 230. In some embodiments, the at least one sensor 230 includes a pressure sensor configured to measure the pressure in the internal volume 206, for example, by measuring the pressure in the outlet 210. Alternatively or additionally, the at least one sensor 230 comprises a flow sensor configured to measure the flow of fluid from the internal volume 206 through the outlet 210.

[0172] According to some exemplary embodiments, an end 232, e.g., a proximal end, of outlet 232 is optionally coupled to an external chamber configured to store fluid extracted from the patient's body via outlet 110. Optionally, the control unit comprises a power source, e.g., a battery, configured to provide power for operation of pump 224. Optionally, the control unit is enclosed in a casing configured to be implanted within the patient's body. In some embodiments, the casing is thin and has a flat surface.

[0173] According to some exemplary embodiments, the control unit 225 is configured to be fully implanted, partially implanted, or external.

[0174] According to some exemplary embodiments, the control circuit 228 is configured to intermittently activate the pump 224 with an interval between two consecutive activation phases during which no pressure is applied to the chamber's internal volume. In some embodiments, the control circuit 228 is configured to activate the pump 224 for a period of less than 15 seconds, e.g., less than 12 seconds, less than 10 seconds, less than 8 seconds, or any intermediate, shorter, or longer period. In some embodiments, the interval duration between two consecutive activation periods is within a range of 20 seconds to 360 seconds, e.g., 20 seconds to 40 seconds, 60 seconds to 300 seconds, or any intermediate, smaller, or larger range of values. In such and other embodiments, the control unit 225 optimizes the interval timing based on the compression and recoil dynamics of the skeleton 213 to optimize net displacement. Optionally, the skeleton 213 is configured to elastically expand and apply force to the inner surface of the body to assist in recoiling the body to the expanded state when the application of negative pressure is stopped. In some embodiments, the skeleton 213 is configured to allow for controlled and / or regulated compression of the chamber body when a vacuum is applied and controlled, and controlled and / or regulated recoil of the chamber body back to the expanded state when the vacuum is stopped, e.g., for an interval period.

[0175] According to some exemplary embodiments, the pump, e.g., pump 224, comprises a gear pump, e.g., an internal gear pump or an external gear pump. A potential advantage of using a gear pump is that the movement of one or more of the gears, optionally teeth, breaks up proteins and / or other aggregates in the fluid, reducing the risk of clogging the tubing and / or pump.

[0176] Alternatively, the pump comprises at least one of a diaphragm pump, a piston pump, and / or a screw pump. In some embodiments, the pump comprises mechanically or electrically actuated valves at the inlet and outlet ends of the pump. Alternatively, the electrically controlled valves are implemented as tube pinch or clamp elements.

[0177] Exemplary Chamber with Collapsible Body Reference is now made to Figures 2E-2F, which illustrate a chamber having a body in a collapsed state and an unfolded, expanded state, according to some exemplary embodiments of the present invention.

[0178] According to some exemplary embodiments, chamber 250 is in a collapsed state, as shown in Figure 2C, for example. In some embodiments, body 252 is coupled to outlet 254 and is in a collapsed state, for example, collapsed within sleeve 256, which functions as a jacket.

[0179] According to some exemplary embodiments, for example, as shown in FIG. 2E , which is a cross-section along axis AA of chamber 250, body 252 is folded within sleeve 256 such that internal support structure 258 is compressed and optionally collapsed, forming tube 260, e.g., a fenestrated tube, also referred to herein as a perforated path within internal volume 262 of body 252.

[0180] According to some exemplary embodiments, in the expanded state, as shown, for example, in Figures 2D and 2F, body 252 is in an unfolded state and support structure 258 is expanded. Further, a flexible stylet 264 is disposed within interior volume 262, for example, to maintain body 252 in the expanded state. In some embodiments, the wall of the body is configured to move between a collapsed, folded state and an expanded, unfolded state. Optionally, the wall is formed from two or more layers, for example, layers 268 and 270. Optionally, each layer has a different fluid permeability and / or a different stiffness.

[0181] According to some exemplary embodiments, for example, as shown in Figures 2G-2I, the fluid-permeable wall of the chamber, including the porous membrane, is configured to fold in a different manner to achieve compact packing of the chamber when the chamber is in a collapsed state. In some embodiments, this membrane folding allows for a minimal profile while, for example, preventing mechanical trauma to the membrane.

[0182] Reference is now made to FIG. 2J, which illustrates a side view of the fluid extraction chamber body in an expanded state, according to some exemplary embodiments of the present invention.

[0183] According to some exemplary embodiments, the body 270 of the fluid extraction chamber in the expanded state comprises a wall 272 defining an interior volume 274, e.g., an interior lumen, and at least one inner tube 276 within the interior volume 274, optionally surrounded by the wall 272. In some embodiments, the at least one inner tube 276 is used to evacuate fluid from the interior volume 274 of the chamber body. Optionally, the at least one inner tube 276 comprises a plurality of pores along the length of the inner tube 276. In some embodiments, the body comprises a support structure, e.g., an expandable scaffold, within the interior volume 274 instead. In these embodiments, the inner tube 276 is optional.

[0184] According to some exemplary embodiments, the body 270 of the fluid extraction chamber is thin in an expanded state, optionally prior to applying pressure to the internal volume 274, and optionally has a foil-like cross-section along the overall width 278 or most of the surface area of ​​the chamber body 270.

[0185] In some embodiments, body 270 has a maximum thickness 279 of up to 3 mm, e.g., up to 2 mm, up to 1 mm, up to 0.7 mm, or any intermediate, smaller, or larger value, along at least 90% of the overall width 278 or surface area of ​​chamber body 270, along at least 95% of the width 278 or surface area of ​​chamber body 270, along at least 98% of the width 278 or surface area of ​​chamber body 270, or any intermediate, smaller, or larger value. In some embodiments, thickness 280 of body 270 at portion 282 of the body including tube 276 is in the range of 2 mm to 8 mm, e.g., in the range of 2 mm to 4 mm, 3 mm to 6 mm, or any intermediate, smaller, or larger value.

[0186] According to some exemplary embodiments, for example, as shown in FIG. 2K, during dynamic fluid extraction, fluid enters interior volume 274 through a membrane in wall 272 at a thinner portion of body 270, which has a maximum thickness of up to 3 mm.

[0187] 1. Exemplary Chamber Implantation According to some exemplary embodiments, the elongate chamber is introduced into a body cavity, for example the abdominal cavity, in a collapsed state, for example in a collapsed state, through one or two openings in the body cavity wall.

[0188] Reference is now made to Figures 3A and 3B, which show the fluid extraction chamber during implantation in a collapsed state in Figure 3A and an expanded state in Figure 3B, according to some exemplary embodiments of the present invention.

[0189] According to some exemplary embodiments, for example as shown in Figure 3A, the elongated fluid extraction chamber 302 is optionally folded within a sheet, for example within a jacket. In some embodiments, the sheet optionally increases the axial stiffness of the chamber 302, for example to aid insertion of the chamber 302 through an opening in the body and / or to prevent undesired expansion, for example, spreading of the chamber 302 outside the body.

[0190] According to some exemplary embodiments, an atraumatic needle such as a Veress needle, e.g., a spring-activated Veress needle, or an introducer dilator is first introduced through the abdominal wall, e.g., to create percutaneous access into the abdominal cavity. In some embodiments, a trocar, e.g., a tunneling trocar 304 over a guidewire 306, is used to enlarge the opening in the abdominal cavity. In some embodiments, a torca, e.g., a connector between the guidewire and a tube, is coupled to the outlet 310 of the chamber 302 and used to guide the chamber 302 into the abdominal cavity over the guidewire 306. In some embodiments, the guidewire 306, trocar 304, and torca are disconnected from the chamber 302 during or before deployment of the chamber 302, as shown, for example, in FIG. 3B . In some embodiments, one or more fixation threads 312 are coupled to the chamber 302. In some embodiments, the threads 312 are configured to be used to remove the chamber 302 from the abdominal cavity and / or to fix the chamber 302 within the abdominal cavity. In some embodiments, the guidewire, introducer, and dilator shaft set is introduced without the use of a tunneling trocar, and second percutaneous access is facilitated through a secondary incision, for example, as shown in FIG. 3C, and optionally through the use of a grasper to grasp the axial guidewire in a dual-access approach.

[0191] According to some exemplary embodiments, the elongated chamber is configured to be inserted into the abdominal cavity using two openings, for example, in a dual access process as shown in Figure 3C. Reference is now made to Figure 3E, which illustrates a process of inserting the chamber into the abdominal cavity using a dual access process, according to some exemplary embodiments of the present invention.

[0192] According to some exemplary embodiments, access to the cavity is provided at two locations at block 320. In some embodiments, access to the cavity is provided at locations (i) and (e) shown in FIG.

[0193] According to some exemplary embodiments, at block 322, a guidewire is passed from site (i) to the contralateral side (e).

[0194] According to some exemplary embodiments, at block 324, a device, for example a chamber, is connected to a wire.

[0195] According to some exemplary embodiments, at block 326, the wire is pulled from location (e) to direct the chamber into the cavity.

[0196] According to some exemplary embodiments, at block 328, a sleeve, eg, a jacket, surrounding the collapsed chamber is pulled outward from the access site (i).

[0197] According to some exemplary embodiments, at block 330, the chamber is optionally expanded by injecting a fluid into the device internal volume, and / or by inserting an expanding stylet, e.g., a stylet frame, and / or by repositioning an internally embedded frame or scaffold, or by different methods described herein.

[0198] According to some exemplary embodiments, at block 332, the stylet frame used to expand the body of the chamber, e.g., body 204 or 302, is locked, optionally to secure the body in a final configuration, e.g., an expanded configuration.

[0199] According to some exemplary embodiments, at block 334, procedural accessories, ie, wires, tunneling guidewires, or trocars and suture wires, are removed.

[0200] According to some exemplary embodiments, the elongated chamber is configured to be inserted into the abdominal cavity using a single opening in a single access process, as shown, for example, in Figure 3D. Reference is now made to Figure 3F, which illustrates a process of inserting the chamber into the abdominal cavity using a single access process, according to some exemplary embodiments of the present invention.

[0201] According to some exemplary embodiments, at block 340, a single access site is formed in the cavity.

[0202] According to some exemplary embodiments, at block 342, a sheath and / or guidewire is positioned inside the access site.

[0203] According to some exemplary embodiments, at block 344, the device is pushed through the sheath and / or guidewire into the cavity.

[0204] According to some exemplary embodiments, the jacket, e.g., a sleeve surrounding the chamber, is removed outwardly through the access site at block 346. Alternatively, the jacket is disassembled.

[0205] According to some exemplary embodiments, at block 348, the chamber is expanded, optionally by injecting a fluid into the interior volume of the chamber.

[0206] According to some exemplary embodiments, at block 350, the stylet and / or frame are locked, as described at block 332.

[0207] According to some exemplary embodiments, at block 352, wires and / or other elements used to insert the chamber are removed, as described at block 334.

[0208] According to some exemplary embodiments, the exit channel, eg, exit 210 or 310, is optionally tunneled subcutaneously, eg, to better anchor the device in place.

[0209] According to some exemplary embodiments, as shown in FIG. 3G, for example, the expanded chamber 302 is implanted within the abdominal cavity 360 inside the peritoneal cavity 362. In some embodiments, the implanted chamber is in contact with two or more regions within the abdominal cavity 360, for example, regions 364, 366, 368, 370, and 372 that are spaced apart within the peritoneum 362. A potential advantage of having an elongated chamber in an expanded state is that it may allow for the drawing of fluid that accumulates in separate, spaced apart regions within the peritoneum or peritoneal cavity, for example, regions 364, 366, 368, 370, and 372, as shown in FIG.

[0210] Exemplary Two-State Stylet According to some exemplary embodiments, the fluid extraction chamber is expanded within the body cavity using a two-state stylet, e.g., a bistable stylet, that can be moved between a collapsed state having a low profile suitable for insertion into the chamber in the collapsed state and an expanded state that allows deployment of the chamber within the body cavity. In some embodiments, a chamber including a bistable stylet is used to extract fluid from a patient suffering from heart failure, e.g., chronic heart failure.

[0211] Reference is now made to Figures 4A-4C, which illustrate the expansion, eg, deployment, of a fluid extraction chamber using a two-state stylet, according to some exemplary embodiments of the present invention.

[0212] According to some exemplary embodiments, as shown, for example, in FIG. 4A , a chamber 402, optionally in the form of a pouch, is in a collapsed state within a jacket 404. In some embodiments, the chamber includes at least one, e.g., a single, flow path into and out of the chamber, e.g., an outlet 401. In some embodiments, as shown, for example, in FIGS. 3A-3F , when the chamber 402 is introduced into a body cavity through an opening, a bistable stylet 403 is introduced into the chamber 402, e.g., into the interior volume of the chamber, through the outlet 401.

[0213] According to some exemplary embodiments, jacket 404, which optionally prevents expansion of the chamber, is removed, for example as shown in FIG. 4B . In some embodiments, jacket 404 is dissolved by fluid within the body cavity. Alternatively or additionally, jacket 404 is dissolved by fluid injected into the interior volume of the chamber or body cavity from outside the body. In some embodiments, jacket 404 is removed from the body through the same opening used to insert the chamber into the body cavity or through a different opening.

[0214] According to some exemplary embodiments, as shown, for example, in FIG. 4C , when jacket 404 is removed, bistable stylet 403 optionally expands laterally, e.g., sideways, within chamber 402 and presses against the inner surface of the chamber wall. In some embodiments, expansion of the stylet causes chamber 402 to expand to an expanded state. In some embodiments, as shown, for example, in FIG. 4C , in the expanded state, the chamber body is narrow and has at least two flat surfaces that are coated or include a porous membrane. Optionally, the at least two flat surfaces are planar. In some embodiments, the flat surfaces are surfaces with bulges extending from the surfaces having a length of less than 2 mm, e.g., less than 1 mm, less than 0.5 mm, or any intermediate, smaller, or larger value.

[0215] Reference is now made to Figures 4D and 4E, which illustrate the composition of the walls of the chamber, according to some exemplary embodiments of the present invention.

[0216] 4E, the walls of chamber 402 include inner and outer layers of permeable membrane 421 and an inner core layer 423 of perforated medium having a fixed or variable spacing. In some embodiments, at least one additional support layer 422 is located between inner membrane layer 421 and inner core layer 423, and between outer membrane layer 421 and inner core layer 423.

[0217] According to some exemplary embodiments, as shown, for example, in Figure 4F, core layer 423 is formed from mesh 430 having fixed spacing 432. Alternatively, as shown, for example, in Figures 4G and 4H, core layer 434 includes cuts 436 or openings at variable locations (4G), or core layer 436 includes openings 440 at different locations and with different sizes. In some embodiments, the core layer is a polymer layer.

[0218] Fluid extraction chamber having a hydrophobic core - Patent Application 20070122997 According to some exemplary embodiments, the fluid extraction chamber comprises a wall having a hydrophobic layer configured to assist expansion of the chamber within the body cavity.

[0219] According to some exemplary embodiments, the degradable hydrophobic-coated inner layer allows for inflation of the chamber by injecting fluid. In some embodiments, this prevents the permeable membrane itself from being distended and damaged by fluid pneumoperitoneum. In some embodiments, once the device is inflated, a diffusion stylet is inserted to maintain the shape of the device after the hydrophobic core is absorbed by fluid. Optionally, positioning of the device is via a dual pull-pull wire mechanism, which also optionally allows for the jacket to be pulled apart. In some embodiments, the hydrophobic layer in the wall allows for initial inflation of the chamber using fluid injected into the interior volume through the outlet without the risk of the injected fluid leaking out of the pores in the wall, for example, through pores in the membrane within the wall. In some embodiments, once the hydrophobic layer is degraded, a stylet is introduced into the chamber to maintain the chamber in a stable, expanded state.

[0220] A potential advantage of initially expanding the chamber using a fluid may be to allow for uniform expansion in all directions by the injected fluid, optionally allowing the shape of the expanded chamber to conform to the space within the body cavity, for example, between organs.

[0221] According to some exemplary embodiments, a chamber having a hydrophobic core is used to effectively expand the collapsed device to its final configuration with minimal use of a metal skeleton, e.g., a stylet.

[0222] Reference is now made to Figures 5A-5C, which illustrate a chamber having a hydrophobic core, according to some exemplary embodiments of the present invention.

[0223] According to some exemplary embodiments, chamber 502 comprises a body having a filtration capsule 504 coupled to a port 506. In some embodiments, for example, as shown in FIG. 5A , chamber 502 is in a collapsed state within a sleeve, e.g., jacket 508, optionally a dissolvable jacket. In some embodiments, thread 510 is coupled to jacket 508, for example, to assist or allow for removal of jacket 508 when chamber 502 is within a body cavity. Optionally, thread 512 is coupled to chamber 502, optionally near or at an outlet of the chamber, for example, to allow for securing chamber 502 after deployment.

[0224] According to some exemplary embodiments, as shown, for example, in FIG. 5B, which is a cross section of chamber 502, chamber 502 includes a tube, e.g., perforated tube 514, which passes through an outlet into the interior volume of the chamber, e.g., into the interior volume of filtration capsule 504. In some embodiments, during deployment, stylet 516 is forced into chamber 502 through outlet 506. In some embodiments, the stylet is optionally forced into the interior volume of filtration capsule 504, into a circumferential channel in the capsule's wall.

[0225] According to some exemplary embodiments, as shown in Figures 5D and 5E, the wall 520 of the filtration capsule consists of two layers: a permeable membrane outer layer 522 and an inner support layer 524 that includes a hydrophobic coating, e.g., a resorbable hydrophobic coating, to allow for initial expansion. Alternatively, only the inner layer, made of a stronger and stiffer material and structure than the outer layer, is coated with the resorbable hydrophobic coating. In some embodiments, the layers are connected at least at some points on the body or along its periphery, and thus move with fluid expansion.

[0226] According to some exemplary embodiments, to expand filtering capsule 504 within chamber 502, e.g., a body cavity, jacket 508 is removed and fluid is injected through tube 514 into the interior volume of the filtering capsule between inner layer 524 having a hydrophobic coating. In some embodiments, the injected fluid repels the hydrophobic layer, causing the filtering capsule to expand. In some embodiments, the support layer within the wall or interior volume of the chamber includes two compartments: at least one compartment shaped and sized to receive a stylet, or alternatively, includes an integrated stylet, and optionally, at least one additional compartment including perforated tube 514.

[0227] Exemplary Fluid Extraction Chamber with Integrated Channels According to some exemplary embodiments, the fluid extraction chamber comprises a body, e.g., a filtration capsule, having an integrated channel within the interior volume of the body. In some embodiments, the integrated channel, e.g., an integrated drainage channel, allows for optionally overcoming localized collapse while maintaining multiple drainage channels within the device without the need for internal collection tubes, e.g., tube 514 shown in Figures 5A and 5B.

[0228] According to some exemplary embodiments, a chamber with an integrated stylet and integrated channels can ensure efficient fluid passage from all areas of the chamber, even in the event of, for example, localized occlusion or collapse.

[0229] Reference is now made to Figures 6A and 6B, which illustrate a fluid extraction chamber with an integrated drainage path, according to some exemplary embodiments of the present invention.

[0230] 6A, chamber 602 comprises a filtration capsule 604 coupled to a body, e.g., an outlet 606. In some embodiments, chamber 602 comprises an integrated stylet 608 configured to expand when a jacket surrounding chamber 602 is removed or dissolved. In some embodiments, the walls of the chamber comprise a permeable medium having an integrated fluid delivery channel 610.

[0231] According to some exemplary embodiments, as shown in FIG. 6B , for example, a chamber 610 comprises a filtering capsule 612, optionally formed as a sac, coupled to an outlet 614. In some embodiments, a resilient support structure, e.g., a permeable skeletal mesh 616, found in the interior volume of the chamber surrounded by the chamber walls and providing mechanical support against an applied vacuum, comprises a plurality of integrated channels 618 that converge at the outlet 614. In some embodiments, the chamber includes an integrated stylet, e.g., an expandable stylet, disposed within the chamber walls. Alternatively, an expandable stylet, e.g., an elastic stylet, is introduced into the chamber walls, optionally into dedicated channels within the walls, to deploy and expand the chamber within the body cavity.

[0232] Exemplary Seals According to some exemplary embodiments, to extract fluid, a vacuum is applied from the exterior of the body to the interior volume of the fluid extraction chamber through an outlet that exits the body cavity through an opening in the wall of the body, e.g., an abdominal wall opening. In some embodiments, the vacuum creates a negative pressure within the interior volume that applies suction to fluid within the body cavity, causing the body cavity fluid to flow into the interior volume of the chamber. In some embodiments, a seal at the abdominal wall opening is used to prevent leakage of the vacuum and suction through the abdominal wall opening and / or any gaps between the outlet tube and the tissue at the abdominal wall opening.

[0233] According to some exemplary embodiments, the body opening seals described herein are part of a system or kit that includes a fluid extraction chamber.

[0234] Reference is now made to FIG. 7, which illustrates a body opening seal, according to some exemplary embodiments of the present invention.

[0235] According to some exemplary embodiments, a seal, e.g., expandable seal 702, is placed in an opening formed in abdominal wall 704. In some embodiments, the seal includes at least one tube, e.g., flexible tube 706, that traverses expandable seal 702. Optionally, tube 706 is made from silicone. In some embodiments, expandable seal 702 is configured to expand outward, e.g., within the opening in the abdominal wall, to seal any gaps between the abdominal wall tissue surrounding the opening and tube 706. In some embodiments, the expandable seal includes a balloon. In some embodiments, inflation of the balloon causes the seal to expand.

[0236] Exemplary fluid removal chamber with gradual opening of pores According to some exemplary embodiments, the fluid extraction chamber comprises a filtration capsule formed from two or more types of porous membranes. In some embodiments, the pores of a first membrane are configured to open and allow fluid to enter the interior volume of the filtration capsule at a pressure threshold different from the pressure threshold required to open the pores of a second membrane. In some embodiments, the gradual opening of the pores allows for maintaining fluid removal over time, for example, when some of the pores of the filtration capsule are clogged.

[0237] According to some exemplary embodiments, a chamber with pressure-dependent opening of pores is used to treat patients suffering from ascites with varying degrees of fluid characteristics, such as liver cirrhosis, cancer, nephrotic syndrome, or advanced heart failure. In some embodiments, the chamber facilitates chronic application of ultrafiltration treatments, for example, chronically and continuously removing extracellular fluid from adjacent tissue while allowing rapid drainage of ascites once rapidly accumulated without encountering the problems of small-pore membranes characterized by other types of membrane behavior, typically resulting from the infiltration of thicker ascites. In some embodiments, the chamber allows for treatment of basal levels of disease by removing ultrafiltrate while also responding to sudden fluid accumulations within a given cavity.

[0238] Reference is now made to Figures 8A-8B, which illustrate chamber walls including two or more types of membrane portions, according to some exemplary embodiments of the present invention.

[0239] According to some exemplary embodiments, chamber 802 includes a wall 804. In some embodiments, wall 804 includes a first type of membrane 806 and a second type of membrane 808 positioned alongside wall 804. In some embodiments, the wall defines an interior volume 810 of the chamber.

[0240] Figure 8C shows a graph illustrating the pressure-dependent opening of pores in each type of membrane, according to some exemplary embodiments of the present invention. Figure 8C includes a graph showing the change in characteristic flow rate (feed rate in ml / min divided by surface area) through the chamber versus pressure within the interior volume of the chamber when the pores in the first and second membranes are opened.

[0241] According to some exemplary embodiments, in the first stage of the filtration process, as shown, for example, in FIG. 8C , only the pores of a first type of membrane, e.g., type A, are open, while the pores of the type B membrane are closed. In some embodiments, as the pressure increases, the filtration rate or volume reaches a plateau, optionally due to clogging of the pores of the type A membrane. In some embodiments, as the pressure in the interior volume of the chamber increases, the pores of the type B membrane open when a certain value, e.g., Pcritical 811, is reached, increasing the characteristic filtration rate per surface area. In some embodiments, when the pressure is higher than Pcritical 811, the pores of both membrane types are open.

[0242] Exemplary Multi-Lumen Port Tube According to some exemplary embodiments, the port of the fluid extraction chamber is coupled to a tube, e.g., a flexible tube, having a first lumen toward the port and the internal volume of the fluid extraction chamber and at least one second lumen toward the body cavity. In some embodiments, having a second lumen allows for the introduction of at least one tool, e.g., a catheter, into the abdominal cavity through a single tube that passes through a single abdominal cavity opening to the implanted fluid extraction chamber.

[0243] Reference is now made to Figures 9A-9C, which illustrate an access tube to a port of a fluid extraction chamber that includes at least one additional external channel, according to some exemplary embodiments of the present invention.

[0244] According to some exemplary embodiments, the fluid extraction chamber 902 comprises a body, e.g., a filtration capsule 904, coupled to an outlet 906. In some embodiments, the outlet 906 is connected to an outlet tube 908. In some embodiments, e.g., as shown in FIG. 9C, the outlet tube 908 extends from the patient's body through a single opening in the abdominal wall.

[0245] According to some exemplary embodiments, the outlet tube comprises at least one additional lumen 912 that terminates outside of the outlet 906. In some embodiments, the at least one additional lumen allows the same opening in the abdominal wall to be used for access to the outlet of the fluid extraction chamber and for introducing at least one tool, for example a catheter, into the abdominal cavity 916.

[0246] According to some exemplary embodiments, the multi-lumen outlet tube is used during dialysis and / or ultrafiltration, for removal of ascites fluid, and for maintenance of a body cavity or fluid extraction device, or any other device implanted in the peritoneal cavity. In some embodiments, the multi-lumen tube is used to introduce a catheter, e.g., a drainage catheter, to drain fluid that accumulates in a body cavity, e.g., the peritoneal cavity, for example, in clinical situations where the fluid accumulates too quickly to allow for efficient removal via chamber 902.

[0247] Exemplary Toxin Removal According to some exemplary embodiments, the level of toxins in the body cavity fluid increases during filtration and / or due to the patient's clinical condition. In some embodiments, beads configured to bind toxins are inserted into the internal volume of the fluid extraction chamber. In some embodiments, after a predetermined period of time, the beads are removed from the fluid extraction chamber and optionally replaced with new beads. In some embodiments, the beads are used to remove protein-bound uremic toxins (PBUTs) such as kynurenine, kynurenic acid, indoxyl sulfate, and hippuric acid, other pro-inflammatory hormones such as TNF-α, interleukin-6 (IL6), and fibrotic mediators such as recombinant MMP-2 protein TIMP metallopeptidase inhibitor 1 (TIMP1) from the body cavity fluid.

[0248] According to some exemplary embodiments, the beads are attached to a string that is introduced into the interior lumen of the chamber through an outlet. In some embodiments, the string is withdrawn from the fluid extraction chamber to remove the beads. Alternatively, suction is applied to remove the beads.

[0249] According to some exemplary embodiments, as shown in FIG. 10A , for example, a fluid extraction chamber 1002 includes an outlet 1004 having at least two separate flow paths into an interior volume 1006 of the chamber 1002. In some embodiments, the outlet is coupled to a multi-lumen tubing. In some embodiments, at least one flow path 1010 is used to insert a tube, such as a perforated tube 1008, into the interior volume 1006, for example, to allow expansion of the chamber 1002 and / or to apply a vacuum. In some embodiments, the flow path 1010 terminates in a tube. In some embodiments, at least one second flow path 1012 is used to deliver beads 1014 to the interior volume 1006. In some embodiments, the beads are coupled to a string. Alternatively, the beads are free-flowing within the interior volume 1006.

[0250] According to some exemplary embodiments, as shown in FIG. 10B , for example, the chamber 1020 includes a single lumen outlet 1022, optionally coupled to a single lumen tube 1024. In some embodiments, the chamber 1020 includes a valve 1026, e.g., a leaflet valve, within the outlet 1022, e.g., between the outlet 1022 and the interior volume 1006. Alternatively, the valve is within the tube 1024 coupled to the outlet 1022. In some embodiments, the valve is used to control the flow of beads 1028 through the single lumen of the outlet 1022, which is also used for fluid removal. In some embodiments, the valve 1026 includes a filter that allows aspiration of fluid from the interior volume 1006 without allowing the beads 1028 to pass to the outlet 1022. In some embodiments, to remove the beads 1028, the filter-containing valve 1026 is dynamically opened, e.g., by inserting a tube from outside the body through the outlet 1022 into the interior volume, leading to the opening of the valve.

[0251] Exemplary Structures of Fluid Extraction Chambers According to some exemplary embodiments, the fluid extraction chamber comprises an expanded body configured to enter a body cavity of a subject, e.g., the abdominal cavity, in a collapsed state, e.g., folded state, and configured to expand, e.g., deploy, within the body cavity. In some embodiments, the body comprises an internal support structure configured to expand the body within the body cavity and / or maintain the body in the expanded state during fluid extraction.

[0252] According to some exemplary embodiments, the inner support structure includes a scaffold, optionally formed from one or more flexible stylets. In some embodiments, the one or more stylets are at least partially coupled to the body or a port in the body through which fluids are expelled from the body lumen during insertion of the chamber into a subject's body cavity. In some embodiments, during deployment of the body within the body cavity, the one or more flexible stylets are pushed into the body lumen from outside the chamber, optionally through a port, to push against the inner surface of the body, thereby stretching the body.

[0253] Alternatively, the one or more stylets are already fully inserted into the internal lumen when the chamber is introduced into the body cavity, and optionally folded with the chamber body in a folded state. In some embodiments, during deployment within the body cavity, the one or more stylets self-expand and press against the inner surface of the body. In some embodiments, expansion of the one or more stylets includes lateral expansion of the stylet. Alternatively or additionally, an elongated deployment tool, e.g., an expansion tool, coupled to the chamber body or the inner scaffold is used to expand the chamber body and / or the scaffold by applying force to the deployment tool from outside the subject's body. In some embodiments, for example, when using a deployment tool, the scaffold, e.g., the one or more stylets, is optional.

[0254] Reference is now made to Figures 10C and 10D, which illustrate the structure of the fluid extraction chamber body, according to some exemplary embodiments of the present invention.

[0255] According to some exemplary embodiments, the fluid extraction chamber 1042 comprises a body 1042 having a wall defining an internal lumen 1044. In some embodiments, the body 1042 is an expandable body configured to move between a collapsed state, e.g., a collapsed and optionally rolled state, during insertion of the chamber 1040 into a body cavity of a subject, and an expanded state, e.g., an optionally unrolled and unfolded state, upon deployment of the fluid extraction chamber within the body cavity of a subject.

[0256] According to some exemplary embodiments, the chamber 1040 further comprises an internal support structure, e.g., a scaffold 1052, within the internal lumen 1044. In some embodiments, the body 1042 comprises an outlet 1046, e.g., a port, through which fluid within the internal lumen can exit the chamber to the reservoir and / or outside the subject via a drain tube. In some embodiments, the scaffold 1052 is configured to expand the body 1042 by applying a force from the internal lumen 1044 outwardly to the inner surface of the wall 1048. In some embodiments, the scaffold is mechanically coupled to the port 1046 and / or the body wall after deployment of the chamber 1040 within the body cavity and / or during dynamic fluid extraction.

[0257] According to some exemplary embodiments, the wall of the body 1042 is formed from at least one outer membrane layer 1048 having pores that allow fluid from the body cavity to pass through to the inner lumen 1044 of the chamber 1040, and at least one porous inner layer 1050, such as a mesh layer or any other porous layer.

[0258] 10D , at least one inner layer 1050 is used to bond two portions of at least one outer membrane layer 1048 together, for example, around the periphery of the body 1042. In some embodiments, the at least one outer membrane layer 1048 or two portions of at least two separate outer membrane layers are welded to at least one inner layer 1050 positioned therebetween, for example, along a double weld seam line. In some embodiments, a seam line is formed between two membrane layers or two portions of a single layer and is located along the circumference of the body 1042. Optionally, the at least one inner layer 1050 is formed from at least one of polyester (PET), polypropylene (PP), ultra-high molecular weight polyethylene (UHMWPE, UHMW), or any derivative thereof, or any other similar material. In some embodiments, the at least one outer membrane layer 1048 is formed from at least one of polyethersulfone (PES), polyvinylidene difluoride (PVDF), polytetrafluoroethylene (PTFE), nylon, cellulose, collagen, or any derivative thereof, or any other similar material.

[0259] According to some exemplary embodiments, at least one guidewire is inserted into the internal lumen 1044 as, or in addition to, the scaffold 1052, for example, to mechanically support the body against external forces and / or to maintain the body in an expanded state.

[0260] Exemplary Fluid Extraction Chamber with Introducible Scaffold According to some exemplary embodiments, the fluid extraction chamber comprises an inner scaffold, optionally an expandable or non-collapsible scaffold. In some embodiments, the inner scaffold is pre-formed to acquire a particular shape when expanded within the body of the fluid extraction chamber. Optionally, the inner scaffold is formed from a shape memory alloy, such as a nickel-titanium alloy (nitinol), a copper-based alloy, an iron-manganese-silicon alloy, an iron-platinum alloy, and / or a gold-cadmium alloy.

[0261] A potential advantage of having a preformed inner scaffold may be that it allows for control of the force applied to the inner surface of the fluid extraction chamber body after expansion, and / or the shape of the fluid extraction chamber body after deployment, and / or the intensity of external forces applied to the fluid extraction chamber, optionally by organs within the body cavity, during movement of the subject.

[0262] Reference is now made to Figures 11A-11D, which illustrate a fluid extraction chamber having an internally introduceable support structure, eg, a scaffold, according to some exemplary embodiments of the present invention.

[0263] According to some exemplary embodiments, the fluid extraction chamber 1102 comprises a body 1104 having an internal lumen 1106. In some embodiments, the body 1104 is configured to be in a collapsed state when inserted into the body cavity and to expand within the body cavity using an internal scaffold, e.g., a support structure. In some embodiments, the wall of the body optionally comprises a porous membrane having pores sized to allow fluid to enter the internal lumen 1106 from the body cavity, as described in FIGS. 1 and 2A . In some embodiments, the body 1104 includes at least one opening, e.g., an outlet opening 1108, configured to allow fluid to exit the internal lumen 1106 via a drainage tube external to the subject, or alternatively, to allow fluid exiting the internal lumen 1106 via a drainage tube and entering an organ of the subject. In some embodiments, the term outlet opening of the fluid extraction chamber should be understood to mean a port or connector in the opening of the chamber body through which fluids and / or other elements can enter or exit the chamber internal lumen.

[0264] According to some exemplary embodiments, the body 1104 is introduced into the subject's body cavity in a collapsed state, as shown, for example, in FIG. 11A , and the inner scaffold 1110 is optionally partially placed into the internal lumen 1106 through at least one exit opening 1108 or through a passage or channel within the exit opening 1106. In some embodiments, the scaffold 1110 is advanced into the body cavity 1106 when the body 1106 of a chamber within the subject's body cavity expands the body 1104 to an expanded state, as shown, for example, in FIG. 11B . In some embodiments, the distal end 1109 of the stylet 1110 is coupled to the port 1108, while the proximal end of the scaffold is configured to move into the internal lumen 1106, for example, to expand the body 1104.

[0265] According to some exemplary embodiments, the scaffold 1110 includes at least one elongated stylet, optionally formed from a shape memory alloy. In some embodiments, when the stylet is advanced into the inner lumen 1106, the stylet pushes outward against the inner surface of the body 1104, causing the body 1104 to expand. In some embodiments, the stylet is pre-shaped, for example, to acquire a particular target shape when advanced into the inner lumen 1106. In some embodiments, the stylet is formed from at least one, or two or more wires of nitinol, metal, and / or polymer material.

[0266] According to some exemplary embodiments, as shown, for example, in Figure 11C, which is a close-up view of the outlet area, the outlet 1108 optionally comprises a recess 1112 on an inner surface of the outlet 1108, or alternatively, on an inner surface of a connector 1114 positioned within the outlet 1108. Optionally, the connector 1114 is shaped and sized to allow a drainage tube to be connected to the body 1104 of the extraction chamber 1102. In some embodiments, the inner surface faces a stylet introduced into the inner lumen 1106.

[0267] According to some exemplary embodiments, the recess 1112 is shaped and sized to conform to the proximal portion 1114 of the stylet to prevent the stylet 1110 from advancing forward into the internal lumen 1106. In some embodiments, the proximal portion 1114 is formed as an angled extension that extends toward the distal end of the stylet toward the internal lumen 1106. In some embodiments, the recess is shaped as an elongated recess that optionally extends at an angle toward the internal lumen 1106. In some embodiments, the elongated proximal portion 1114 is forced into the elongated recess as the proximal portion of the stylet 1110 passes through the outlet 1108. In some embodiments, the interaction between the elongated, extending proximal portion 1114 of the stylet 1110 and the recess 1112 mechanically prevents the stylet from advancing forward into the internal lumen 1106.

[0268] According to some exemplary embodiments, movement of the scaffold 1110, e.g., rotation of the scaffold, releases the proximal portion from the exit opening, e.g., from the connector, optionally allowing the scaffold 1110 to be withdrawn from the internal lumen 1106, e.g., allowing the chamber 1102 to be removed from the body cavity of the subject.

[0269] Exemplary Fluid Extraction Chamber with Integrated Scaffolding Reference is now made to Figures 12A and 12B, which illustrate a fluid extraction chamber with an integrated scaffold, according to some exemplary embodiments of the present invention.

[0270] According to some exemplary embodiments, the fluid extraction chamber 1202 comprises a body 1204 having an internal lumen 1206 and at least one outlet opening 1208. In some embodiments, the chamber 1202 includes at least one inner scaffold 1210 integrated with the body 1204. In some embodiments, the scaffold 1210 is coupled to the body 1204 when the chamber 1202 is in a compressed state, as shown in FIG. 12A, during introduction of the chamber 1202 into a body cavity of a subject, and when the chamber 1202 is deployed within the body cavity to attain an expanded state, as shown in FIG. 12B, for example. In some embodiments, in a collapsed state, as shown in FIG. 15A, the chamber 1202, including the outer membrane, is configured to collapse and unfold to an expanded state, as shown in FIG. 12B. In some embodiments, the scaffold 1210 is at least partially mechanically coupled to the inner surface of the body 1204. Alternatively or additionally, the scaffold is mechanically coupled to, for example, a connector positioned at or forming, the port opening 1208 .

[0271] According to some exemplary embodiments, for example, as described with respect to scaffold 1110, scaffold 1210 is optionally formed from a shape memory alloy and includes at least one elongated stylet. Optionally, scaffold 1210 is thin, having a thickness value of 0.2 mm to 1.7 mm, e.g., 0.2 mm to 0.7 mm, 0.5 mm to 1.2 mm, 0.8 mm to 1.7 mm, or any intermediate, smaller, or larger thickness value. Optionally, the cross-section of the stylet is circular, round, oval, elliptical, polygonal, or rectangular in shape. In some embodiments, the stylet is formed from at least one, or two or more wires of nitinol, metal, and / or polymer material.

[0272] According to some exemplary embodiments, scaffold 1210 is flexible and optionally resilient. In some embodiments, scaffold 1210 is configured to fold into two partially elliptical portions that partially overlap each other when the chamber is in a compressed state, for example, as shown in FIG. 12A . Optionally, scaffold 1210 is configured to fold to form a spiral shape having at least two partially overlapping portions when the chamber is in a collapsed state, for example, as shown in FIG. 12A , optionally during introduction of chamber 1202 into a body cavity. In some embodiments, the scaffold is unfolded to acquire a round shape, pressing against the inner surface of body 1204 and expanding body 1204 and chamber 1202, for example, as shown in FIG. 12B . Optionally, scaffold 1210 is configured to fold within a body cavity, optionally to allow removal of chamber 1202 from the body cavity of a subject.

[0273] Reference is now made to Figures 13A and 13B, which illustrate an inner scaffold formed from at least two elongated stylets, at least one outer stylet, and at least one inner stylet, according to some exemplary embodiments of the present invention.

[0274] According to some exemplary embodiments, the fluid extraction chamber 1302 comprises a body 1304 having an internal lumen 1306 and an exit opening 1308 to the internal lumen 1306. Optionally, for example, as shown in FIG. 13A , the body 1304 comprises an internal pouch within the internal lumen 1306. In some embodiments, the chamber 1302 comprises at least one internal scaffold formed from at least one outer stylet 1310 and at least one internal stylet 1312. In some embodiments, each stylet has a different level of elasticity to resist different external forces applied to the body 1304, for example, from the outside. In some embodiments, the at least one internal scaffold including the outer stylet 1310 and the internal stylet 1312 is disposed within the internal lumen 1306 of the body 1304, and optionally within the pouch.

[0275] Optionally, the at least one inner scaffold including the outer stylet 1310 and the inner stylet 1312 is integral with the body 1304 and is mechanically coupled, for example, to the inner surface of the pouch, the body 1304, or the outlet 1308, e.g., a port. Alternatively or additionally, the at least one inner scaffold including the outer stylet 1310 and the inner stylet 1312 is mechanically coupled to the outlet 1308, optionally to at least one connector disposed within the outlet. Optionally or additionally, the outer stylet 1310 and the inner stylet 1312 are mechanically coupled to one another, for example, to enable simultaneous deployment. In some embodiments, in the expanded state, the diameter of the at least one inner scaffold 1312 is smaller than the diameter of the at least one outer scaffold 1310. In some embodiments, the outer stylet 1310 and inner stylet 1312 are arranged and / or function in a tandem configuration, for example, against an external force applied to the body 1304. In some embodiments, the inner and / or outer stylets are formed from at least one, or two or more wires of nitinol, metal and / or polymer material.

[0276] According to some exemplary embodiments, for example, as shown in FIG. 13B , having an inner scaffold formed from at least one outer stylet 1310 and at least one inner stylet 1312 optionally allows for gradual collapse of the body 1304 due to pressure applied to the body 1304 by tissue within an organ 1320 or body cavity. In some embodiments, the organ 1320 pushes the outer membrane of the body 1304 inward, bending the outer stylet 1310 inward toward the inner stylet 1312. In some embodiments, the inner stylet 1312 is less flexible and / or more flex-resistant compared to the outer stylet 1310 to resist pressure applied by the organ 1320. In some embodiments, the inner stylet 1312 allows for maintaining a functional volume of the inner lumen 1306 sufficient for expansion and compression of the body when pressure is applied by a pump to the inner volume 1306 for removal of fluid from the body cavity.

[0277] Optionally, outer stylet 1310 and inner stylet 1312 are similar to stylet 1210 described in Figures 12A and 12B.

[0278] Exemplary Extensions of Fluid Extraction Chambers According to some exemplary embodiments, the fluid extraction chamber comprises at least one support structure, e.g., an inner scaffold, disposed within the internal lumen of the fluid extraction chamber body. In some embodiments, the at least one inner scaffold is an expandable scaffold configured to move from a collapsed state to an expanded state within the subject's body cavity. Optionally, the at least one scaffold is a reversibly expandable scaffold configured to move from an expanded state to a collapsed state within the subject's body cavity, e.g., to enable removal of the fluid extraction chamber from the subject's body cavity. In some embodiments, expansion of the scaffold expands the fluid extraction chamber.

[0279] According to some exemplary embodiments, the scaffold is a self-expandable scaffold. Alternatively, the scaffold expands in response to a force applied to the scaffold and / or the fluid extraction chamber body from outside the subject's body. Optionally, the applied force changes the configuration and / or shape of the scaffold. Alternatively or additionally, the applied force changes the configuration and / or shape of the fluid extraction chamber body. In some embodiments, applying a force from outside the subject's body makes it possible, for example, to control the expansion timing and / or shape of the expanded fluid extraction chamber. In some embodiments, the external force applied to the fluid extraction chamber body is optionally used to push against an organ within the subject's body cavity to clear a sufficient volume from the body cavity for the fluid extraction chamber to expand.

[0280] Reference is now made to Figures 14A-14C, which illustrate the expansion of a fluid extraction chamber using at least one external rod, according to some exemplary embodiments of the present invention.

[0281] According to some exemplary embodiments, the fluid extraction chamber 1402 comprises a body 1404 having an internal lumen 1406 and at least one outlet opening 1408 for fluidly connecting the internal lumen 1406 with at least one tube 1407. In some embodiments, the chamber 1402 comprises at least one inner scaffold 1410 configured to move between a collapsed state, e.g., folded into two loops, to an expanded state, optionally upon insertion of the chamber into a body cavity of a subject, as shown in FIG. 14A , where the inner scaffold 1410 expands laterally to form a single loop, e.g., upon deployment of the chamber 1402 within the body cavity of a subject.

[0282] Optionally, when introducing the fluid extraction chamber 1402 into the subject's body cavity, the body 1404 is disposed within an outer jacket, for example, as shown in FIG. 14A . In some embodiments, the jacket is a dissolvable jacket configured to dissolve when exposed to fluid in the subject's body cavity. Alternatively, the jacket is a removable jacket configured to be retracted from the subject's body cavity after inserting the chamber 1402 into the subject's body cavity. In some embodiments, the jacket, optionally formed from at least one sheet of material, is configured to reduce friction between the outer surface of the chamber body 1404 and the subject's tissue during insertion of the chamber 1402 into the subject's body cavity. Optionally, the jacket is configured to be retracted from the subject's body. Optionally, the jacket is a tearable jacket.

[0283] According to some exemplary embodiments, after positioning the chamber 1402 within a body cavity of a subject, at least one elongated deployment tool, e.g., a rod 1414, is introduced into the internal lumen 1406 of the body 1404 through the exit opening 1408 and contacts the scaffold 1410. In some embodiments, the proximal end of the rod 1414 is positioned outside the subject's body, e.g., to allow manipulation of the rod and its distal end from outside the subject's body. Optionally, the rod 1414 is introduced into the lumen 1406 after removal of the outer jacket. In some embodiments, e.g., as shown in FIG. 14B , the rod 1414, e.g., the distal end 1416, applies a force to the scaffold 1410, optionally pushing against the scaffold 1410, which is sufficient to move the scaffold from a collapsed state to an expanded state and expand the body 1404.

[0284] Alternatively, the chamber 1402 is introduced into the body cavity of the subject while the rod 1414, e.g., the distal end 1416 of the rod 1414, is already mechanically coupled to the scaffold 1410 and the proximal end of the rod 1414 is positioned outside the subject's body. In some embodiments, after expansion of the scaffold 1410, the rod 1414 is retracted from the expanded body 1404 via the outlet 1408.

[0285] According to some exemplary embodiments, the rod 1414 is rigid axially along the long axis of the rod 1414, and optionally flexible laterally at an angle relative to the long axis, for example to allow the rod 1414 to be advanced and / or retracted forward within the tube connected to the outlet 1408, while optionally allowing the rod 1414 to bend within the tube.

[0286] Reference is now made to Figures 14D-14G, which illustrate decoupling of the deployment rod from the scaffold, according to some exemplary embodiments of the present invention.

[0287] According to some exemplary embodiments, for example, as shown in Figures 14D and 14E, rod 1420 is a hollow rod having at least one wire 1422 passing through a lumen 1424 of rod 1420 between a proximal end of the rod located outside the subject and a distal end 1426 of rod 1420 mechanically coupled to scaffold 1410. In some embodiments, pulling at least one wire 1422 severs distal end 1426 from scaffold 1410, and optionally tears distal end 1426 from scaffold 1410, for example, as shown in Figure 14E.

[0288] 14F and 14G, rod 1430 includes a gripping portion 1432, e.g., a proximal end of rod 1430 located outside the body cavity of the subject, e.g., a distal gripping portion configured to grip and release scaffold 1410 in response to manipulation of the rod's proximal portion. Optionally, rod 1430 is a gripping instrument or a rod of a gripping instrument.

[0289] According to some exemplary embodiments, the fluid extraction chamber is expanded using at least one external expansion tool, e.g., a spreader, which is controlled from outside the body cavity and is used to apply a force on the chamber body sufficient to at least partially expand the chamber. In some embodiments, the spreader expands the chamber body to an extent that allows expansion of the inner scaffold, e.g., to stabilize the chamber body in its expanded state within the body cavity.

[0290] Reference is now made to Figures 15A-15C, which illustrate the expansion of a fluid extraction chamber using an expansion tool, for example, a spreader, according to some exemplary embodiments of the present invention.

[0291] According to some exemplary embodiments, the fluid extraction chamber 1502 comprises a body 1504, e.g., an expandable body 1504, having an internal lumen 1506 and at least two exit openings 1508 and 1512 into the internal lumen 1506. In some embodiments, the chamber 1502 includes at least one inner scaffold 1510 disposed within the internal lumen 1506. In some embodiments, the at least one inner scaffold 1510 is mechanically coupled to an expansion tool, e.g., a spreader including at least two elongated rods 1508 and 1512, each penetrating into the internal lumen 1506 via a different exit opening of openings 1508 and 1512, as shown, for example, in FIG. 15A . Optionally, the chamber 1502 is disposed within a jacket 1503 when introduced into the body cavity of a subject.

[0292] According to some exemplary embodiments, when the chamber 1502 is introduced into a body cavity, organs and / or tissues within the body cavity apply a force to the outer surface of the body 1504, preventing expansion of the inner scaffold and / or body 1504. In some embodiments, for example, as shown in FIG. 15B , to enable expansion of the scaffold 1510 and / or body 1504, each of the at least two rods 1514 and 1516 pushes against the inner surface of the body 1504 or scaffold 1510 in opposite directions, causing the body 1504 to expand. In some embodiments, the distal ends of each of the rods optionally move in opposite directions relative to each other, for example, to expand the body 1504. In some embodiments, the force applied by each of the rods 1514 and 1516 to the wall of the body 1504 pushes against the tissue and / or organs being pushed from outside on the body 1504 to an extent that enables expansion of the inner scaffold 1510 to stabilize the body 1504 in the expanded state.

[0293] According to some exemplary embodiments, the body 1504 in the expanded state has a trapezoidal shape.

[0294] According to some exemplary embodiments, following expansion of the body 1504 and / or inner scaffold 1510, the spreader including at least two rods is retracted, and the outlets 1508 and 1512 are connected to at least one pump 1520 via tubes 1522 and 1524. Optionally, the tubes 1522 and 1524 are coupled to the pump via a connector, for example, a Y-connector 1526, as shown in FIG.

[0295] Reference is now made to Figures 16A-16C, which illustrate that expansion of a fluid extraction chamber using an expansion tool includes at least two external rods, according to some exemplary embodiments of the present invention.

[0296] 16A and 16B , the chamber 1602 comprises a body 1604 having an internal lumen 1606 and at least one exit opening 1608. In some embodiments, the chamber 1602 includes at least one internal scaffold 1610, optionally a stylet. In some embodiments, the exterior surface of the body 1604 is mechanically coupled to the spreader, e.g., to at least two rods of the spreader, e.g., rods 1614 and 1616. In some embodiments, each of the rods 1614 and 1616 is coupled to the exterior surface of the body 1604 by at least one fastener, e.g., loops 1618 and 1620. According to some exemplary embodiments, the rods 1614 and 1616 are optionally substantially parallel to one another during insertion of the chamber 1602 into the body cavity of the subject. In some embodiments, after chamber 1602 is positioned within a body cavity of a subject, the rods, optionally located outside the subject's body, e.g., proximal portions of each of portions 1629 and 1629, are moved toward the proximal portions of different rods, optionally moving distal ends 1630 and 1632 of the rods further apart from each other, e.g., as shown in FIG. 16B. Optionally, proximal portions 1627 and 1629 are moved until they intersect each other, e.g., as shown in FIG. 16B. In some embodiments, the movement of the proximal portions of rods 1514 and 1516 shown in FIGS. 15A and 15B is similar to the movement of proximal portions 1627 and 1629.

[0297] According to some exemplary embodiments, when the distal ends of rods 1614 and 1616 are moved away from one another, body 1604 expands, allowing scaffold 1610 to expand and stabilize body 1604 in the expanded state. In some embodiments, following expansion of chamber body 1604 and scaffold 1610, rods 1614 and 1616 are retracted and pulsed out of the body cavity, optionally using wires 1613 and 1615, each extending from the proximal end of a different rod.

[0298] In some embodiments, the rods described herein are straight rods or angled rods. In some embodiments, the rods described herein are flexible or rigid.

[0299] Reference is now made to Figures 17A-17C, which illustrate the expansion of the fluid extraction chamber using an external expansion tray, according to some exemplary embodiments of the present invention.

[0300] According to some exemplary embodiments, the fluid extraction chamber 1702, shown in dashed lines, comprises a body 1704, e.g., an expandable body, having an internal lumen 1706, and at least one inner scaffold 1710 within the internal lumen 1706. Additionally, the body 1704 optionally comprises at least one exit opening 1708 to the internal lumen 1706 configured to allow extraction of fluid from the chamber 1702 and the internal lumen 1706 via at least one tube coupled to the exit opening 1708.

[0301] According to some exemplary embodiments, during insertion of the chamber 1702 into a body cavity of a subject, the chamber 1702 is coupled to an external extension tray 1730, represented by a continuous line and circle in FIGS. 17A-17C.

[0302] According to some exemplary embodiments, the expansion tray 1730 includes at least one elongated plate 1732 and at least two movable arms 1734 and 1736, each optionally coupled to the plate 1732 by at least one hinge, e.g., hinges 1738 and 1740. In some embodiments, the at least two movable arms 1734 and 1736 are configured to move between a first state in which the arms 1734 and 1738 are substantially aligned with the longitudinal axis of the plate 1732 and / or optionally fully overlap the plate 1732, and a second state in which the arms 1734 and 1736 extend laterally relative to the plate 1732.

[0303] According to some exemplary embodiments, expansion tray 1702 comprises at least one elongated actuation bar 1742 operatively coupled to arms 1734 and 1736 and / or hinges 1738 and 1740. In some embodiments, movement, e.g., axial movement, of bar 1742 moves the arms between a first state and a second state.

[0304] According to some exemplary embodiments, chamber 1702 is coupled, optionally reversibly coupled, to arms 1734 and 1736. Optionally, arms 1734 and 1736 are connected to opposite ends of body 1704.

[0305] 17A, during insertion of chamber 1702 into a subject, chamber 1702 is coupled to tray 1730 and held in a collapsed state by tray 1730. In some embodiments, arms 1734 and 1736 are substantially aligned with plate 1732 in the first state to hold chamber 1702 in the collapsed state.

[0306] According to some exemplary embodiments, actuation bar 1742 is moved, for example, axially and / or rotated, to expand chamber 1702, as shown, for example, in FIG. 17B. Optionally, bar 1742 is retracted to expand chamber 1702, as shown, for example, in FIG. 17B. In some embodiments, movement of bar 1742, e.g., retraction of the bar, moves arms 1734 and 1736 to a second state, where arms 1734 and 1736 extend laterally away from plate 1732. In some embodiments, extension of arms 1724, which are mechanically coupled to body 1704, expands body 1704. In some embodiments, expansion of body 1704 allows inner scaffold 1710 to expand and stabilize body 1704 and chamber 1702 in a functionally expanded state, optionally ready for functional extraction of fluid from the body cavity when negative pressure is applied to internal lumen 1706 by a pump via an outlet. In some embodiments, the expansion tray is removed from the subject when arms 1734 and 1736 return to the first state, where they are substantially aligned with plate 1732.

[0307] Optionally, further manipulation, such as axial and / or rotational manipulation of the bar 1742, as shown in FIG. 17C, can decouple the extension tray 1730 from the chamber 1702, allowing, for example, the extension tray 1730 to be withdrawn from the subject.

[0308] Reference is now made to Figures 17D and 17E, which illustrate the movement of the arms of an extension tray, according to some exemplary embodiments of the present invention.

[0309] According to some exemplary embodiments, each of the arms of the extension tray, e.g., arm 1750, is operatively coupled to the body 1750 of the fluid extraction chamber via at least one loop, e.g., loop 1754, of the body 1750. Optionally, the arm 1750 is reversibly coupled to the loop by a wire 1756. In some embodiments, the wire 1756 is tied to the loop by a knot that can be opened, for example, to optionally decouple the arm 1750 from the loop 1754 and the chamber body 1752, when the wire is pulled.

[0310] According to some exemplary embodiments, arm 1750 includes a gear 1760 at the proximal end of arm 1750. In some embodiments, the teeth of gear 1760 match with recesses 1762 between the teeth at the distal end of an elongated actuation bar 1764 and are operatively coupled to elongated actuation bar 1764 such that axial movement of bar 1764 translates into rotational movement of gear 1760 and movement of arm 1750. In some embodiments, as shown in FIG. 17E, for example, retraction of bar 1764 causes arm 1750 to extend laterally, expanding body 1754.

[0311] Exemplary Chamber Deployment According to some exemplary embodiments, the fluid extraction device is inserted into a body cavity, for example, the abdominal cavity. In some embodiments, the body cavity is not insufflated. Optionally, the fluid extraction chamber is introduced into the body cavity under local anesthesia.

[0312] According to some exemplary embodiments, the fluid extraction chamber is introduced into the body cavity in a collapsed state, for example in a collapsed state, optionally while the inner scaffold is at least partially coupled to the chamber body. In some embodiments, when introducing the chamber into the body cavity, one or more organs or tissues within the body cavity need to be displaced to have space for proper deployment of the chamber.

[0313] In some embodiments, an expansion tool is used to assist in the expansion of the chamber, e.g., widening of the chamber within the body cavity. In some embodiments, the expansion tool is coupled to the chamber and / or inner scaffold and extends from the body cavity. In some embodiments, manipulation of the tool from outside the body cavity, e.g., from outside the subject's body, applies sufficient force to the chamber body and / or inner scaffold to expand the chamber within the body cavity. In some examples, the use of a combination of manipulation from outside and within the body is utilized, e.g., insertion of one or more additional expansion guidewires into the internal lumen of the chamber body.

[0314] Reference is now made to FIG. 18, which illustrates a process for deploying a fluid extraction chamber within a body cavity using an expansion tool, according to some exemplary embodiments of the present invention.

[0315] According to some exemplary embodiments, an opening to a body cavity is formed at block 1802. In some embodiments, the opening is formed, for example, as described in block 106 of Figure 1. In some embodiments, the opening is formed under local anesthesia.

[0316] According to some exemplary embodiments, at block 1804, the fluid extraction chamber is introduced into the body cavity through the shaped opening. In some embodiments, the chamber, optionally an elongated chamber, is introduced into the body cavity in a collapsed state, e.g., where the chamber body is folded or rolled, within an outer sleeve (e.g., jacket) that encases the chamber and optionally maintains the chamber in the collapsed state. In some embodiments, the chamber comprises an internal expandable scaffold at least partially coupled to the chamber body or an outlet, e.g., a port, of the chamber body during insertion into the body cavity. In some embodiments, the fluid extraction chamber is coupled to at least one expansion tool, e.g., a dilator. In some embodiments, the dilator is an elongated dilator having a distal end coupled to the chamber and a proximal end located outside the body cavity, optionally outside the subject.

[0317] According to some exemplary embodiments, the outer sleeve is removed from the chamber at block 1806. In some embodiments, the outer sleeve is removed from the body cavity through the formed opening. In some embodiments, the outer sleeve is removed by, for example, pulling a wire coupled to the outer sleeve from outside the subject.

[0318] According to some exemplary embodiments, optionally at block 1808, the proximal end of the inner scaffold is moved into the chamber. In some embodiments, the inner scaffold is moved into the chamber to expand the chamber body within the body cavity. In some embodiments, the inner scaffold is moved into the chamber, for example, as described in FIGS. 11A-11D .

[0319] Alternatively, optionally, if the entire scaffold is already within the chamber, for example, during insertion of the chamber into the body cavity, the scaffold self-expands, and optionally expands or spreads laterally, at block 1804. In some embodiments, the scaffold self-expands or self-deploys after the outer sleeve is removed at block 1806.

[0320] According to some exemplary embodiments, an expansion tool is moved at block 1810. In some embodiments, an expansion tool including at least one rod, e.g., as shown in Figures 14A-14G, or at least two rods, e.g., as shown in the figures, e.g., at least two rods, e.g., as shown in Figures 15A-15C and 16A-16C, or an expansion tray, e.g., as shown in Figures 17A-17E, is moved from outside the body cavity, e.g., from outside the subject's body.

[0321] According to some exemplary embodiments, movement of the expansion tool includes axial movement and / or rotation. In some embodiments, movement of the expansion tool expands, e.g., widens, the chamber body. Optionally, expansion of the chamber body allows the inner scaffold to expand and maintain the chamber in an expanded state.

[0322] In some embodiments, when an expansion tool, e.g., a dilator, is used, the inner scaffold is optional and the device does not include an inner scaffold. In these embodiments, after expansion, the chamber is rigid enough to remain expanded and / or to resist external forces without the inner scaffold.

[0323] According to some exemplary embodiments, the expansion tool is removed from the body cavity at block 1812. In some embodiments, the expansion tool is decoupled from the chamber and removed by pulling one or more wires from outside the body cavity. In some embodiments, the expansion tool is decoupled from the chamber by applying force to a tear region between the tool and the chamber and / or by releasing at least one gripping head of the tool from the chamber, as shown, for example, in Figures 14D-14G.

[0324] According to some exemplary embodiments, the chamber is coupled to a tube and / or a pump at block 1814. In some embodiments, the chamber is coupled to a tube and / or a pump after expansion of the chamber within the body cavity. In some embodiments, at least one outlet or at least one port of the chamber is coupled to at least one tube, for example, a drain tube.

[0325] When used herein in reference to an amount or value, the term "about" means "within ±10% of."

[0326] The words "comprises," "comprising," "includes," "including," "has," "having," and their conjugations mean "including, but not limited to."

[0327] The term "consisting of" means "including and limited to."

[0328] The term "consisting essentially of" means that a composition, method, or structure may include additional components, steps, and / or moieties, but only if the additional components, steps, and / or moieties do not materially alter the basic and novel characteristics of the claimed composition, method, or structure.

[0329] As used herein, the singular forms "a," "an," and "the" include plural references unless the context clearly dictates otherwise. For example, the term "a compound" or "at least one compound" may include a plurality of compounds, including mixtures thereof.

[0330] Throughout this application, embodiments of the invention may be presented with reference to a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the invention. Accordingly, the description of a range should be considered to have specifically disclosed all possible subranges as well as individual numerical values ​​within that range. For example, a description of a range such as "1 to 6" should be considered to have specifically disclosed subranges such as "1 to 3," "1 to 4," "1 to 5," "2 to 4," "2 to 6," "3 to 6," and the individual numerical values ​​within that range, e.g., 1, 2, 3, 4, 5, and 6. This applies regardless of the breadth of the range.

[0331] Whenever a numerical range (e.g., "10-15," "10 to 15," or any pair of numbers linked by these or another such range designators) is given herein, it is meant to include any number (decimal or integral) within the stated range limits, inclusive of the range limits, unless the context clearly dictates otherwise. A "range / ranging / ranges between" a first and a second designated number and a "range / ranging / ranges from" a first designated number to a second designated number (or another such range designator) are used interchangeably herein and are meant to include the first and second designated numbers and all decimals and integers therebetween.

[0332] Unless otherwise indicated, the numerical values ​​used herein and any numerical ranges based thereon are approximations within the accuracy of reasonable measurement and rounding errors, as will be understood by one of ordinary skill in the art.

[0333] As used herein, the term "treating" includes arresting, substantially inhibiting, slowing, or reversing the progression of a condition, substantially ameliorating the clinical or cosmetic symptoms of a condition, or substantially preventing the appearance of clinical or cosmetic symptoms of a condition.

[0334] It will be understood that certain features of the invention that are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention that are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable subcombination, or as suitable in any other described embodiment of the invention. Certain features described in the context of various embodiments are not considered essential features of those embodiments, unless the embodiment is inoperable without those elements.

[0335] While the present invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications, and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications, and variations that fall within the spirit and broad scope of the appended claims.

[0336] It is the intention of the applicants that all publications, patents, and patent applications mentioned herein be incorporated by reference in their entirety as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference herein. In addition, citation or identification of any reference in this application shall not be construed as an admission that such reference is available as prior art to the present invention. To the extent section headings are used, they should not be construed as necessarily limiting. In addition, any priority document of this application is incorporated herein by reference in its entirety.

Claims

1. 1. A fluid extraction chamber suitable for implantation into a non-pneumoperitoneum peritoneal cavity, comprising: an elongate expandable body having a major axis and a minor axis and configured to move from a collapsed state to an expanded state when deployed within the non-pneumoperitoneal cavity, the elongate expandable body including a fluid permeable wall defining an interior volume of the elongate expandable body; an elongated expandable body that, in a collapsed state, is shaped and sized to penetrate an opening in an abdominal wall to reach a non-pneumoperitoneal cavity, and in an expanded state, the elongated expandable body is thin and has a surface area that is at least five times greater than the surface area of ​​the elongated expandable body in the collapsed state; an outlet coupled to the elongate, expandable body having at least one opening to the interior volume.

2. The chamber of claim 1 , wherein the chamber is suitable for implantation into the non-pneumoperitoneal peritoneal cavity under local anesthesia.

3. 3. The chamber of claim 1 or 2, wherein the maximum width of the elongate expandable body in the expanded state is at least three times greater than the maximum width of the elongate expandable body in the collapsed state.

4. 4. The chamber of claim 1, further comprising a resilient porous skeleton within the interior volume in contact with an inner surface of the fluid-permeable wall, the resilient porous skeleton configured to exert a force against the inner surface and to collapse when the elongate body is in a collapsed state and to expand when the elongate expandable body is in an expanded state when deployed in the non-inflated peritoneal cavity.

5. The chamber of claim 4 , wherein the resilient porous scaffold comprises at least one layer of resilient semi-rigid mesh.

6. 6. The chamber of claim 4 or 5, wherein the elastic porous scaffold is shaped as a sponge.

7. A chamber according to any one of claims 4 to 6, wherein the pores of the elastic porous skeleton have similar sizes and / or shapes.

8. A chamber according to any one of claims 4 to 6, wherein the pores of the elastic porous skeleton have different sizes and / or shapes.

9. 9. The chamber of claim 4, wherein the elastic porous skeleton comprises supporting structures and / or materials configured to allow expansion of the elastic porous skeleton when the elastic porous skeleton is stretched.

10. 10. The chamber of any one of claims 4 to 9, wherein the elastic porous skeleton includes integrated channels that converge into the outlet, the integrated channels shaped and sized to direct fluid entering the interior volume through different portions of the body towards the outlet.

11. 11. The chamber of any one of claims 1 to 10, wherein in the expanded state, the elongate expandable body is substantially flat and thin, having a maximum thickness of less than 2 mm along at least 90% of the width of the body.

12. A chamber according to any one of the preceding claims, wherein the ratio between the width and length of the body in an expanded state is at least 1:1.

4.

13. The chamber of any one of claims 1 to 12, wherein the ratio between the length and width of the elongate expandable body in the collapsed state is at least 3:

1.

14. The chamber of any one of claims 1 to 13, wherein the maximum width of the elongate expandable body in the collapsed state is less than 10 mm.

15. The chamber of any one of claims 1 to 14, wherein in the expanded state, the body includes a flexible stylet configured to push outwardly against the fluid-permeable wall.

16. The chamber of claim 15 , wherein the flexible stylet is integrated into the body.

17. 16. The chamber of claim 15, wherein the body includes a circumferential channel configured to receive the flexible stylet, the flexible stylet configured to be inserted through the outlet into the circumferential channel via the outlet when the elongate expandable body is within the abdominal cavity.

18. The chamber of claim 15, wherein the flexible stylet is configured to be inserted into the interior volume through the outlet.

19. The chamber of any one of claims 15 to 18, wherein the flexible stylet is a bi-state flexible stylet configured to move between a collapsed state and an expanded state.

20. 20. The chamber of any one of claims 1 to 19, comprising a jacket disposed around the elongate, expandable body when the elongate, expandable body is in the collapsed state, the jacket configured to increase the longitudinal stiffness of the elongate, expandable body.

21. 21. The chamber of claim 20, comprising one or more threads coupled to the jacket and configured to allow removal of the jacket from the elongate expandable body from outside the abdominal cavity.

22. 22. The chamber of claim 20 or 21, wherein the jacket is formed from a dissolvable material configured to dissolve upon interaction with fluid in the abdominal cavity.

23. 23. The chamber of any one of claims 1 to 22, wherein an inner surface of the fluid-permeable wall facing the interior volume is coated with a degradable coating configured to seal the fluid-permeable wall from passage of fluid therethrough.

24. 24. The chamber of claim 23, wherein the coating is a hydrophobic coating.

25. The chamber of any preceding claim, comprising a perforated tube coupled to the outlet and extending into the internal volume.

26. A chamber according to any preceding claim, wherein the wall comprises at least one membrane layer having pores with a size in the range of 0.1 μm to 100 μm.

27. 27. The chamber of any one of claims 1 to 26, wherein the fluid-permeable wall is at least partially formed from at least two types of membranes, and wherein pores of at least one membrane of the at least two membrane types are configured to open to allow the passage of fluid under a pressure level that is a different form of pressure level required to open pores of a second membrane of the at least two membrane types.

28. 28. The chamber of any one of claims 1 to 27, wherein the outlet comprises at least one flow path and a filter valve within the flow path, the filter valve configured to allow fluid to pass therethrough when the valve is closed and to open when a tool is inserted through the outlet towards the internal volume.

29. 29. A chamber according to any one of claims 1 to 28, wherein the outlet comprises at least two separate flow paths into the internal volume, at least one flow path being used for extracting fluid from the internal volume and at least one second flow path being used for introducing toxin-binding beads into the internal volume.

30. 1. A fluid removal system comprising: A chamber according to claim 1; an inflatable seal including at least one tube traversing the inflatable seal; The fluid removal system, wherein the tube is configured to be fluidly coupled to the outlet, and the inflatable seal is configured to be positioned in the opening in the abdominal wall and to seal a gap between the abdominal wall and the tube when inflated.

31. 1. A fluid removal system comprising: A chamber according to claim 1; a tube configured to traverse the abdominal wall through the opening, at least one end of the tube coupled to the outlet and at least one second end of the tube configured to be positioned outside the patient's body, the tube including at least two separate channels passing therethrough, an end of a first channel of at least one of the at least two separate channels fluidly coupled to the outlet and an end of a second channel of at least one of the at least two separate channels fluidly coupled to the non-pneumoperitoneal peritoneal cavity.

32. 32. The system of claim 31 , wherein the at least one second channel is a tool channel configured to allow insertion of a tool into the abdominal cavity from outside the body while the at least one first channel is fluidly coupled to the outlet.

33. 1. An expandable seal comprising: an expandable body shaped and sized to be positioned within the opening in the abdominal wall and configured to move between a collapsed state and an expanded state; and at least one tube traversing the expandable body, the at least one tube including at least one opening configured to be positioned within the abdominal cavity and at least one opening configured to be positioned outside the abdominal cavity, wherein the expandable body is configured to seal a gap between the abdominal wall and the at least one tube when expanded.

34. 1. A fluid extraction chamber suitable for implantation into the abdominal cavity, comprising:

1. A fluid extraction chamber comprising: an expandable body configured to move from a collapsed state to an expanded state, the expandable body including a fluid-permeable wall including at least one layer of a porous membrane, the fluid-permeable wall defining an interior volume of the body, an inner layer of the fluid-permeable wall being coated with a degradable coating, the expandable body being shaped and sized to penetrate an opening in an abdominal wall into an abdominal cavity in the collapsed state and to expand within the abdominal cavity by injecting a fluid into the interior volume, the degradable coating being configured to temporarily seal the pores of the membrane to prevent the injected fluid from leaving the interior volume and passing through the fluid-permeable wall.

35. 35. The chamber of claim 34, wherein the coating is a hydrophobic coating.

36. 1. A fluid extraction chamber suitable for implantation into a body cavity, comprising: an elongate expandable body configured to transition from a collapsed state to an expanded state upon deployment within the body lumen, the elongate expandable body including a fluid permeable wall defining an interior volume of the elongate expandable body; an outlet coupled to the elongate expandable body, the outlet having at least one opening to the interior volume; and at least one flexible, elongated stylet positioned within the internal volume and at least partially coupled to the outlet or the body when the elongated, expandable body is introduced into the body cavity, the at least one flexible, elongated stylet configured to push the fluid-permeable wall outward from within the internal volume to expand the elongated, expandable body within the body cavity during the deployment of the elongated, expandable body.

37. 37. The chamber of claim 36, wherein the elongate expandable body has a major axis and a minor axis.

38. 38. The chamber of claim 36 or 37, wherein the at least one elongate flexible stylet includes a distal end mechanically coupled to the outlet and a proximal end configured to be introduced into the internal volume and mechanically coupled to the outlet during deployment of the elongate expandable body.

39. 39. The chamber of claim 38, wherein the proximal end of the at least one elongated flexible stylet includes an extension shaped and sized to match a recess in the outlet.

40. 38. The chamber of claim 36 or 37, wherein the at least one elongated, flexible stylet is integrated with the elongated, expandable body and positioned within the internal volume while the elongated, expandable body is inserted into the body cavity, and the at least one elongated, flexible stylet is configured to fold into two or more overlapping ring-shaped portions when the elongated, expandable body is in a folded state and to expand into a single ring-shaped portion when the elongated, expandable body is deployed within the body cavity.

41. 41. The chamber of any one of claims 36 to 40, wherein the at least one elongate, flexible stylet includes at least one outer stylet and at least one inner stylet, and when the elongate, expandable body is in an expanded state, the at least one outer stylet pushes outward against the fluid-permeable wall, and the at least one inner stylet is positioned between the at least one outer stylet and a center point of the internal volume.

42. 42. The chamber of any one of claims 36 to 41, comprising an elongate deployment tool having a distal end reversibly coupled to the at least one flexible, elongate stylet and / or the elongate, expandable body and a proximal end positioned outside the body cavity, wherein movement of the proximal end applies a force to the at least one flexible, elongate stylet and / or the elongate, expandable body sufficient to expand the elongate, expandable body within the body cavity.

43. 43. The chamber of claim 42, wherein the elongate deployment tool includes at least one elongate rod that enters the interior volume through the outlet, the at least one elongate rod having a distal end reversibly coupled to the at least one flexible elongate stylet and a proximal end located outside the body cavity, and wherein axial advancement and / or rotation of the proximal end moves the at least one flexible elongate stylet from a collapsed state to an expanded state.

44. the outlet comprises at least two outlet openings, and the elongate deployment tool comprises at least two elongate rods, each of which enters the interior volume through a different one of the at least two outlet openings; 43. The chamber of claim 42, wherein when the elongate expandable body is within the body cavity, movement of the proximal ends of the at least two elongate rods relative to one another applies a force to the fluid-permeable wall sufficient to expand the elongate expandable body within the body cavity.

45. the elongate deployment tool includes at least two elongate rods reversibly operably coupled to the elongate expandable body on opposite sides of the elongate expandable body; 43. The chamber of claim 42, wherein when the elongate expandable body is within the body cavity, movement of the proximal ends of the at least two elongate rods relative to one another applies a force to the elongate expandable body sufficient to expand the elongate expandable body within the body cavity.

46. the elongated deployment tool includes an expansion tray, the expansion tray including an elongated plate, at least two arms pivotally coupled to the tray on opposite sides thereof, and at least one elongated actuation rod operably coupled to the at least two arms, the at least two arms being configured to be reversibly coupled to opposite sides of the elongated expandable body; 43. The chamber of claim 42, wherein when the chamber is positioned within the body cavity, movement of a portion of the at least one elongate actuation rod located outside the body cavity moves the arms from a first state in which the arms are substantially aligned with a longitudinal axis of the tray to a second state in which the arms extend laterally from the plate while being reversibly coupled to the opposite sides of the elongate expandable body, thereby expanding the elongate expandable body within the body cavity.

47. A chamber according to any one of claims 36 to 46, wherein the chamber is suitable for implantation into a non-pneumoperitoneum body cavity.

48. 48. The chamber of claim 47, wherein the non-inflated body cavity includes a non-inflated abdominal cavity, and wherein in the collapsed state, the elongated expandable body is shaped and sized to penetrate an opening in an abdominal wall to reach the non-inflated abdominal cavity, and wherein in the expanded state, the elongated expandable body is thin and has a surface area at least five times greater than the surface area of ​​the elongated expandable body in the collapsed state.

49. A chamber according to any one of claims 36 to 48, wherein the fluid-permeable wall comprises at least one membrane layer having pores with a size in the range of 0.1 μm to 100 μm.

50. 1. A fluid extraction chamber suitable for implantation into a body cavity, comprising: an expandable body configured to move from a collapsed state to an expanded state when deployed within the body lumen, the expandable body including a fluid-permeable wall defining an interior volume of the expandable body; an outlet coupled to the expandable body having at least one opening to the interior volume; A fluid extraction chamber, wherein the expandable body is formed from two portions of at least one porous membrane layer fixedly adhered to at least one mesh layer positioned therebetween to form a seam line around the circumference of the expandable body surrounding the internal volume.

51. 1. A method for deploying an elongated fluid extraction chamber, comprising: locally anesthetizing an area within the abdominal wall of a selected target subject to form an opening through the abdominal wall into the non-pneumoperitoneal peritoneal cavity; forming the opening in the area of ​​the target; introducing an elongated fluid extraction chamber in a collapsed state through the opening into the non-pneumoperitoneal cavity, the elongated fluid extraction chamber having a fluid-permeable wall defining an interior volume and an outlet for the interior volume; and expanding the elongated fluid extraction chamber within the non-pneumoperitoneal cavity to obtain a surface area at least five times greater than the surface area of ​​the elongated fluid extraction chamber in the collapsed state.

52. 52. The method of claim 51, wherein the expanding comprises expanding the elongated fluid extraction chamber to have an outer flat surface and a thickness of less than 2 mm.

53. 53. The method of claim 51 or 52, wherein the expanding comprises expanding the elongated fluid extraction chamber by introducing a stylet into the interior volume or into a circumferential channel in the fluid-permeable wall.

54. 54. The method of any one of claims 51 to 53, wherein the fluid extraction chamber includes an integral stylet configured to move between a collapsed state and an expanded state, and the expanding includes expanding the fluid extraction chamber by moving the stylet to an expanded state.

55. 55. A method according to any one of claims 51 to 54, wherein the inner layer of the fluid-permeable wall comprises a degradable sealing layer configured to temporarily seal the fluid-permeable wall from the passage of fluid, and wherein the expanding comprises expanding the elongated fluid extraction chamber by injecting fluid into the internal volume.

56. 56. The method of any one of claims 51 to 55, comprising, following said expansion, intermittently applying a negative pressure to said internal volume through said outlet sufficient to draw fluid from said non-pneumoperitoneal peritoneal cavity, through said fluid permeable wall, into said internal volume, and out of said internal volume through said outlet.

57. 57. The method of any one of claims 51 to 56, comprising diagnosing the subject with chronic heart failure or acute heart failure prior to the administration of local anesthesia.

58. 57. The method of any one of claims 51 to 56, comprising detecting ascites in the subject prior to the local anesthesia.

59. detecting protein-bound uremic toxins (PBUTs) in the subject; 57. The method of any one of claims 51 to 56, comprising: following said expanding, introducing into said internal volume beads configured to bind said PBUT.

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