Percutaneous ultrafiltration

Abstract

A fluid extraction chamber adapted for implantation into a non-blown abdominal cavity, the fluid extraction chamber comprising: an elongate expandable body having a long axis and a short axis and configured to move from a collapsed state to an expanded state when deployed in the non-blown abdominal cavity, wherein the elongate expandable body comprises a fluid permeable wall, the fluid permeable wall defining an interior volume of the elongate expandable body; wherein in the collapsed state, the elongate expandable body is shaped and sized to pass through an opening in the abdominal wall into the non-blown abdominal cavity, and wherein in the expanded state, the elongate expandable body is shaped and sized to pass through the opening in the abdominal wall into the non-blown abdominal cavity. The elongate expandable body is thin and the surface area of the elongate expandable body is at least 5 times the surface area of the elongate expandable body in the collapsed state; and an outlet coupled to the elongate expandable body, the outlet having at least one opening to the interior volume.

Description

[0001] Related applications

[0002] This application claims the benefit of priority under 35 USC §119(e) to U.S. Provisional Patent Application No. 63 / 436,129, filed on December 30, 2022, the contents of which are incorporated herein by reference in their entirety.

[0003] Technical Field and Background

[0004] In some embodiments of the present invention, the present invention relates to ultrafiltration devices and methods, and more particularly, but not exclusively, to percutaneously implantable ultrafiltration devices and methods. Summary of the Invention

[0005] Some examples of some embodiments of the present invention are listed below (an embodiment may include features from more than one example and / or less than all features of an example):

[0006] Example 1. A fluid extraction chamber adapted for implantation into a non-insufflated abdominal cavity, the fluid extraction chamber comprising:

[0007] an elongated inflatable body having a major axis and a minor axis and configured to move from a collapsed state to an expanded state when deployed in the non-insufflated abdominal cavity, wherein the elongated inflatable body comprises a fluid-permeable wall defining an interior volume of the elongated inflatable body;

[0008] wherein in the collapsed state, the elongate expandable body is shaped and sized to pass through an opening in the abdominal wall into a non-insufflated abdominal cavity, and wherein in the expanded state, the elongate expandable body is thin and has a surface area that is at least 5 times the surface area of ​​the elongate expandable body in the collapsed state;

[0009] An outlet is coupled to the elongated expandable body, the outlet having at least one opening to the interior volume.

[0010] Example 2. The chamber of Example 1, wherein the chamber is adapted for implantation into the non-insufflated abdominal cavity under local anesthesia.

[0011] Example 3. The chamber of any of Examples 1 or 2, wherein the maximum width of the elongated expandable body in the expanded state is at least 3 times the maximum width of the elongated expandable body in the collapsed state.

[0012] Example 4. A chamber according to any of the preceding examples, comprising an elastic porous skeleton located in the interior volume, the elastic porous skeleton in contact with the inner surface of the fluid permeable wall, wherein the elastic porous skeleton is configured to apply a force to the inner surface to collapse when the slender body is in a collapsed state and to expand when the slender expandable body is in an expanded state when deployed in the non-insufflated abdominal cavity.

[0013] Example 5. The chamber of Example 4, wherein the elastic porous framework comprises at least one layer of an elastic semi-rigid mesh.

[0014] Example 6. The chamber of any one of Examples 4 or 5, wherein the elastic porous skeleton is shaped as a sponge.

[0015] Example 7. The chamber of any one of Examples 4 to 6, wherein the pores in the elastic porous framework have similar sizes and / or shapes.

[0016] Example 8. The chamber of any one of Examples 4 to 6, wherein the pores in the elastic porous framework have varying sizes and / or shapes.

[0017] Example 9. The chamber of any one of Examples 4 to 8, wherein the elastic porous framework comprises an auxetic structure and / or an auxetic material configured to allow the elastic porous framework to expand when the elastic porous framework is stretched.

[0018] Example 10. A chamber according to any one of Examples 4 to 9, wherein the elastic porous framework comprises integrated flow paths that converge in the outlet, and wherein the shape and size of the integrated flow paths are set to direct fluid entering the interior volume through different parts of the body toward the outlet.

[0019] Example 11. The chamber of any preceding example, wherein the body has a thickness of less than 2 mm in the expanded state.

[0020] Example 12. A chamber according to any of the preceding examples, wherein the ratio of the width to the length of the body in the expanded state is at least 1:1.5.

[0021] Example 13. The chamber of any of the preceding examples, wherein the ratio of the length to the width of the elongated expandable body in the collapsed state is at least 5:1.

[0022] Example 14. The chamber of any of the preceding examples, wherein the maximum width of the elongated expandable body in the collapsed state is less than 10 mm.

[0023] Example 15. The chamber of any preceding example, wherein in the expanded state, the body comprises a flexible stylet configured to push the fluid-permeable wall outward.

[0024] Example 16. A chamber according to Example 15, wherein the flexible tube needle is integrated into the body.

[0025] Example 17. A chamber according to Example 15, wherein the body includes a circumferential channel, the circumferential channel is configured to accommodate the flexible guide needle, and wherein the flexible guide needle is configured to be inserted into the circumferential channel through the outlet when the slender expandable body is located in the abdominal cavity.

[0026] Example 18. The chamber of Example 15, wherein the flexible stylet is configured to be inserted into the interior volume via the outlet.

[0027] Example 19. The chamber of any of Examples 15 to 18, wherein the flexible stylet is a dual-state flexible stylet configured to move between a collapsed state and an expanded state.

[0028] Example 20. The chamber of any preceding example, comprising a sheath positioned around the elongate expandable body when the elongate expandable body is in the collapsed state.

[0029] Example 21. The chamber of Example 20, wherein the sheath is configured to increase the stiffness of the elongated expandable body in the direction of the long axis.

[0030] Example 22. The chamber of any of Examples 20 or 21, comprising one or more wires coupled to the sheath, the one or more wires configured to allow removal of the sheath from the elongated expandable body from outside the abdominal cavity.

[0031] Example 23. The chamber of any of Examples 20 to 22, wherein the sheath is formed of a dissolvable material configured to dissolve upon interaction with fluid in the peritoneal cavity.

[0032] Example 24. A chamber according to any of the preceding examples, wherein an inner surface of the fluid-permeable wall facing the interior volume is coated with a degradable coating, the degradable coating being configured to seal the fluid-permeable wall to prevent fluid from passing through the fluid-permeable wall.

[0033] Example 25. The chamber of Example 24, wherein the coating is a hydrophobic coating.

[0034] Example 26. The chamber of any preceding example, comprising a perforated tube coupled to the outlet and extending into the interior volume.

[0035] Example 27. The chamber of any preceding example, wherein the wall comprises at least one membrane layer having pores with a size ranging between 0.1 μm and 100 μm.

[0036] Example 28. A chamber according to any of the preceding examples, wherein the fluid permeable wall is at least partially formed by at least two types of membranes, wherein the pores of at least one of the at least two membrane types are configured to open at a pressure level different from the pressure level required to open the pores of at least one second membrane of the at least two membrane types to allow fluid to pass through.

[0037] Example 29. A chamber according to any of the preceding examples, wherein the outlet comprises at least one flow path and a filter valve located in the flow path, wherein the filter valve is configured to allow fluid to pass when the valve is closed and to open when a tool is inserted through the outlet toward the internal volume.

[0038] Example 30. A chamber according to any of the preceding examples, wherein the outlet comprises at least two separate flow paths into the interior volume, wherein at least one flow path is used to extract fluid from the interior volume and wherein at least one second flow path is used to introduce toxin-bound beads into the interior volume.

[0039] Example 31. A fluid removal system comprising:

[0040] The chamber according to claim 1;

[0041] An inflatable seal comprising at least one tube passing through the inflatable seal, wherein the tube is configured to be fluidly coupled to the outlet, and wherein the inflatable seal is configured to be positioned in the abdominal wall opening and to seal a gap between the abdominal wall and the tube when inflated.

[0042] Example 32. A fluid removal system comprising:

[0043] The chamber according to claim 1;

[0044] a tube configured to pass through the abdominal wall through the opening, wherein at least one end of the tube is coupled to the outlet port, and wherein at least a second end of the tube is configured to be positioned outside the patient's body, wherein the tube comprises at least two separate channels passing therethrough, wherein an end of at least one first of the at least two separate channels is fluidly coupled to the outlet port, and wherein an end of at least one second of the at least two separate channels is fluidly coupled to the non-insufflated abdominal cavity.

[0045] 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.

[0046] Example 34. An expandable seal comprising:

[0047] 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;

[0048] At least one tube is passed through 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 when the expandable body is configured to seal a gap between the abdominal wall and the at least one tube when expanded.

[0049] Example 35. The seal of Example 34, wherein the expandable body comprises a bladder and an inflation port for the bladder.

[0050] Example 36. The seal of any of Examples 34 or 35, wherein the tube comprises at least two separate flow paths.

[0051] Example 37. A fluid extraction chamber adapted for implantation into the peritoneal cavity, the fluid extraction chamber comprising:

[0052] An expandable body configured to move from a collapsed state to an expanded state, wherein the expandable body comprises a fluid-permeable wall comprising at least one layer of a porous membrane, wherein the fluid-permeable wall defines an interior volume of the body, wherein an inner layer of the fluid-permeable wall is coated with a degradable coating; wherein in the collapsed state, the expandable body is shaped and sized to pass through an opening in the abdominal wall into the abdominal cavity and to expand within the abdominal cavity by injecting fluid into the interior volume, and wherein the degradable coating is configured to temporarily seal the pores of the membrane to prevent the injected fluid from flowing out of the interior volume through the fluid-permeable wall.

[0053] Example 38. A chamber according to Example 37, wherein the coating is a hydrophobic coating.

[0054] Example 39. A method for deploying an elongated fluid extraction chamber, the method comprising:

[0055] locally anesthetizing a subject's abdominal wall in an area selected as a target for forming an opening through the abdominal wall into a non-inflated abdominal cavity;

[0056] forming the opening in the target area;

[0057] introducing an elongated fluid extraction chamber in a collapsed state into the non-inflated abdominal cavity through the opening, the elongated fluid extraction chamber having a fluid permeable wall defining an interior volume and an outlet from the interior volume;

[0058] The elongate fluid extraction lumen is expanded within the non-inflated abdominal cavity to obtain a surface area that is at least 5 times the surface area of ​​the elongate fluid extraction lumen in the collapsed state.

[0059] Example 40. The method of Example 39, wherein the expanding comprises expanding the elongated fluid extraction chamber so that it has an outer flat surface and a thickness of less than 2 mm.

[0060] Example 41. The method of any of Examples 39 or 40, wherein the expanding comprises expanding the elongated fluid extraction chamber by introducing a stylet into the interior volume or a circumferential channel in the fluid-permeable wall.

[0061] 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 wherein the expansion includes expanding the fluid extraction chamber by moving the stylet to the expanded state.

[0062] 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, the degradable sealing layer being configured to temporarily seal the fluid-permeable wall to prevent fluid from passing therethrough, and wherein the expansion comprises expanding the elongated fluid extraction chamber by injecting fluid into the interior volume.

[0063] Example 44. The method of any one of examples 39 to 43, comprising:

[0064] Subsequent inflations of the negative pressure are intermittently applied to the interior volume through the outlet port, the negative pressure being sufficient to draw fluid from the non-inflated abdominal cavity into the interior volume through the fluid permeable wall and out of the interior volume through the outlet port.

[0065] Example 45. The method of any one of examples 39 to 44, comprising:

[0066] Prior to the local anesthesia, the subject is diagnosed with chronic heart failure or acute heart failure.

[0067] Example 46. The method of any one of examples 39 to 44, comprising:

[0068] Before the local anesthesia, ascites is detected in the subject.

[0069] Example 47. The method of any one of examples 39 to 44, comprising:

[0070] detecting protein-bound uremic toxins (PBUT) in the subject;

[0071] Beads configured to bind to the PBUT are introduced into the interior volume after the expansion.

[0072] Here are some additional examples of some embodiments of the invention (an embodiment may include features from more than one example and / or less than all of the features of an example):

[0073] Example 1. A fluid extraction chamber adapted for implantation into a non-insufflated abdominal cavity, the fluid extraction chamber comprising:

[0074] an elongated inflatable body having a major axis and a minor axis and configured to move from a collapsed state to an expanded state when deployed in the non-insufflated abdominal cavity, wherein the elongated inflatable body comprises a fluid-permeable wall defining an interior volume of the elongated inflatable body;

[0075] wherein in the collapsed state, the elongate expandable body is shaped and sized to pass through an opening in the abdominal wall into a non-insufflated abdominal cavity, and wherein in the expanded state, the elongate expandable body is thin and has a surface area that is at least 5 times the surface area of ​​the elongate expandable body in the collapsed state;

[0076] An outlet is coupled to the elongated expandable body, the outlet having at least one opening to the interior volume.

[0077] Example 2. The chamber of Example 1, wherein the chamber is adapted for implantation into the non-insufflated abdominal cavity under local anesthesia.

[0078] Example 3. The chamber of any of Examples 1 or 2, wherein the maximum width of the elongated expandable body in the expanded state is at least 3 times the maximum width of the elongated expandable body in the collapsed state.

[0079] Example 4. A chamber according to any of the preceding examples, comprising an elastic porous skeleton located in the interior volume, the elastic porous skeleton in contact with the inner surface of the fluid permeable wall, wherein the elastic porous skeleton is configured to apply a force to the inner surface to collapse when the slender body is in a collapsed state and to expand when the slender expandable body is in an expanded state when deployed in the non-insufflated abdominal cavity.

[0080] Example 5. The chamber of Example 4, wherein the elastic porous framework comprises at least one layer of an elastic semi-rigid mesh.

[0081] Example 6. The chamber of any one of Examples 4 or 5, wherein the elastic porous skeleton is shaped as a sponge.

[0082] Example 7. The chamber of any one of Examples 4 to 6, wherein the pores in the elastic porous framework have similar sizes and / or shapes.

[0083] Example 8. The chamber of any one of Examples 4 to 6, wherein the pores in the elastic porous framework have varying sizes and / or shapes.

[0084] Example 9. The chamber of any one of Examples 4 to 8, wherein the elastic porous framework comprises an auxetic structure and / or an auxetic material configured to allow the elastic porous framework to expand when the elastic porous framework is stretched.

[0085] Example 10. A chamber according to any one of Examples 4 to 9, wherein the elastic porous framework comprises integrated flow paths that converge in the outlet, and wherein the shape and size of the integrated flow paths are set to direct fluid entering the interior volume through different parts of the body toward the outlet.

[0086] Example 11. The chamber of any preceding example, wherein in the expanded state, the elongated expandable body is substantially flat and thin, the elongated expandable body having a maximum thickness of less than 2 mm along at least 90% of the width of the body.

[0087] Example 12. A chamber according to any of the preceding examples, wherein the ratio of the width to the length of the body in the expanded state is at least 1:1.4.

[0088] Example 13. The chamber of any of the preceding examples, wherein the ratio of the length to the width of the elongated expandable body in the collapsed state is at least 3:1.

[0089] Example 14. The chamber of any of the preceding examples, wherein the maximum width of the elongated expandable body in the collapsed state is less than 10 mm.

[0090] Example 15. The chamber of any preceding example, wherein in the expanded state, the body comprises a flexible stylet configured to push the fluid-permeable wall outward.

[0091] Example 16. A chamber according to Example 15, wherein the flexible tube needle is integrated into the body.

[0092] Example 17. A chamber according to Example 15, wherein the body includes a circumferential channel, the circumferential channel is configured to accommodate the flexible guide needle, and wherein the flexible guide needle is configured to be inserted into the circumferential channel through the outlet when the slender expandable body is located in the abdominal cavity.

[0093] Example 18. The chamber of Example 15, wherein the flexible stylet is configured to be inserted into the interior volume via the outlet.

[0094] Example 19. The chamber of any of Examples 15 to 18, wherein the flexible stylet is a dual-state flexible stylet configured to move between a collapsed state and an expanded state.

[0095] Example 20. A chamber according to any of the preceding examples, comprising a sheath, which is placed around the slender expandable body when the slender expandable body is in the collapsed state, wherein the sheath is configured to increase the stiffness of the slender expandable body in the direction of the long axis.

[0096] Example 21. The chamber of Example 20, comprising one or more wires coupled to the sheath, the one or more wires configured to allow removal of the sheath from the elongated expandable body from outside the abdominal cavity.

[0097] Example 22. The chamber of any of Examples 20 or 21, wherein the sheath is formed of a dissolvable material configured to dissolve upon interaction with fluid in the peritoneal cavity.

[0098] Example 23. A chamber according to any of the preceding examples, wherein an inner surface of the fluid-permeable wall facing the interior volume is coated with a degradable coating, the degradable coating being configured to seal the fluid-permeable wall to prevent fluid from passing through the fluid-permeable wall.

[0099] Example 24. The chamber of Example 23, wherein the coating is a hydrophobic coating.

[0100] Example 25. The chamber of any preceding example, comprising a perforated tube coupled to the outlet and extending into the interior volume.

[0101] Example 26. The chamber of any preceding example, wherein the wall comprises at least one membrane layer having pores with a size ranging between 0.1 μm and 100 μm.

[0102] Example 27. A chamber according to any of the preceding examples, wherein the fluid permeable wall is at least partially formed by at least two types of membranes, wherein the pores of at least one of the at least two membrane types are configured to open at a pressure level different from the pressure level required to open the pores of at least one second membrane of the at least two membrane types to allow fluid to pass through.

[0103] Example 28. A chamber according to any of the preceding examples, wherein the outlet comprises at least one flow path and a filter valve located in the flow path, wherein the filter valve is configured to allow fluid to pass when the valve is closed and to open when a tool is inserted through the outlet toward the internal volume.

[0104] Example 29. A chamber according to any of the preceding examples, wherein the outlet comprises at least two separate flow paths into the interior volume, wherein at least one flow path is used to extract fluid from the interior volume and wherein at least one second flow path is used to introduce toxin-bound beads into the interior volume.

[0105] Example 30. A fluid removal system comprising:

[0106] The chamber according to claim 1;

[0107] an inflatable seal comprising at least one tube passing through the inflatable seal,

[0108] Wherein the tube is configured to be fluidly coupled to the outlet, and wherein the inflatable seal is configured to be positioned in the abdominal wall opening and to seal a gap between the abdominal wall and the tube when inflated.

[0109] Example 31. A fluid removal system comprising:

[0110] The chamber according to example 1;

[0111] a tube configured to pass through the abdominal wall through the opening, wherein at least one end of the tube is coupled to the outlet port, and wherein at least a second end of the tube is configured to be positioned outside the patient's body, wherein the tube comprises at least two separate channels passing therethrough, wherein an end of at least one first of the at least two separate channels is fluidly coupled to the outlet port, and wherein an end of at least one second of the at least two separate channels is fluidly coupled to the non-insufflated abdominal cavity.

[0112] 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 fluidically coupled to the outlet.

[0113] Example 33. An expandable seal comprising:

[0114] 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;

[0115] At least one tube is passed through 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 when the expandable body is configured to seal a gap between the abdominal wall and the at least one tube when expanded.

[0116] Example 34. A fluid extraction chamber adapted for implantation into the peritoneal cavity, the fluid extraction chamber comprising:

[0117] An expandable body configured to move from a collapsed state to an expanded state, wherein the expandable body comprises a fluid-permeable wall comprising at least one layer of a porous membrane, wherein the fluid-permeable wall defines an interior volume of the body, wherein an inner layer of the fluid-permeable wall is coated with a degradable coating; wherein in the collapsed state, the expandable body is shaped and sized to pass through an opening in the abdominal wall into the abdominal cavity and to expand within the abdominal cavity by injecting fluid into the interior volume, and wherein the degradable coating is configured to temporarily seal the pores of the membrane to prevent the injected fluid from flowing out of the interior volume through the fluid-permeable wall.

[0118] Example 35. A chamber according to Example 34, wherein the coating is a hydrophobic coating.

[0119] Example 36. A fluid extraction chamber adapted for implantation into a body cavity, the fluid extraction chamber comprising:

[0120] an elongated expandable body configured to move from a collapsed state to an expanded state when deployed in the body lumen, wherein the elongated expandable body comprises a fluid permeable wall defining an interior volume of the elongated expandable body;

[0121] an outlet coupled to the elongated expandable body, the outlet having at least one opening to the interior volume;

[0122] At least one flexible, elongated stylet is positioned within the interior volume and is at least partially coupled to the outlet or the body when the elongated expandable body is introduced into the body cavity, wherein the at least one flexible, elongated stylet is configured to push the fluid-permeable wall outward from within the interior volume during the deployment of the elongated expandable body so as to expand the elongated expandable body within the body cavity.

[0123] Example 37. The chamber of Example 36, wherein the elongated expandable body has a major axis and a minor axis.

[0124] Example 38. A chamber according to any of Examples 36 or 37, wherein the at least one slender flexible guide needle includes a distal end and a proximal end, the distal end being mechanically connected to the outlet, and the proximal end being configured to be introduced into the internal volume and mechanically connected to the outlet during expansion of the slender expandable body.

[0125] Example 39. The chamber of Example 38, wherein the proximal end of the at least one elongated flexible stylet includes an extension shaped and sized to mate with a recess in the outlet.

[0126] Example 40. A chamber according to any of Examples 36 or 37, wherein the at least one slender flexible guide pin is integrated with the elongated expandable body and is positioned within the internal volume during insertion of the elongated expandable body into the body cavity, wherein the at least one slender flexible guide pin is configured to fold into two or more partially overlapping annular portions when the elongated expandable body is in a collapsed state and to expand into a single annular portion when the elongated expandable body is unfolded in the body cavity.

[0127] Example 41. A chamber according to any one of Examples 36 to 40, wherein the at least one slender flexible tube needle comprises at least one outer tube needle and at least one inner tube needle, wherein when the slender expandable body is in an expanded state, the at least one outer tube needle pushes the fluid permeable wall outward, and the at least one inner tube needle is positioned between the at least one outer tube needle and the center point of the internal volume.

[0128] Example 42. A chamber according to any one of Examples 36 to 41, comprising a slender deployment tool having a distal end and a proximal end, the distal end being reversibly connected to the at least one flexible slender stylet and / or the elongated expandable body, and the proximal end being positioned outside the body cavity, wherein movement of the proximal end applies a force on the at least one flexible slender stylet and / or the elongated expandable body sufficient to cause the elongated expandable body to expand in the body cavity.

[0129] Example 43. A chamber according to Example 42, wherein the slender deployment tool comprises at least one slender rod, the at least one slender rod passing through the outlet and entering the internal volume, wherein the at least one slender rod has a distal end and a proximal end, the distal end is reversibly connected to the at least one flexible elongated tube needle, and the proximal end is located outside the body cavity, wherein axial advancement and / or rotation of the proximal end causes the at least one flexible elongated tube needle to move from a collapsed state to an expanded state.

[0130] Example 44. The chamber of example 42, wherein the outlet comprises at least two outlet openings, and wherein the elongated deployment tool comprises at least two elongated rods, each of the at least two elongated rods passing through a different one of the at least two outlet openings into the interior volume;

[0131] Wherein, when the elongated expandable body is located within the body cavity, movement of the proximal ends of the at least two elongated shafts relative to each other exerts a force on the fluid permeable wall sufficient to expand the elongated expandable body in the body cavity.

[0132] Example 45. The chamber of example 42, wherein the elongated deployment tool comprises at least two elongated rods reversibly functionally coupled to the elongated expandable body at opposite sides of the elongated expandable body;

[0133] Wherein, when the elongated expandable body is located within the body cavity, movement of the proximal ends of the at least two elongated rods relative to each other exerts a force on the elongated expandable body sufficient to expand the elongated expandable body in the body cavity.

[0134] Example 46. The chamber of example 42, wherein the elongated deployment tool comprises an expansion tray, wherein the expansion tray comprises an elongated plate, at least two arms pivotally coupled to the tray at opposite sides of the tray, and at least one elongated actuation rod functionally coupled to the at least two arms, wherein the at least two arms are configured to reversibly couple to opposite sides of the elongated expandable body;

[0135] wherein when the chamber is positioned within the body cavity, movement of a portion of the at least one elongated actuator rod located outside the body cavity causes the arm to move from a first state in which the arm is substantially aligned with the long axis of the tray to a second state in which the arm extends laterally from the plate while being reversibly coupled to the opposite side of the elongated expandable body, thereby causing the elongated expandable body to expand within the body cavity.

[0136] Example 47. The chamber of any of Examples 36 to 46, wherein the chamber is adapted for implantation into a non-insufflated body cavity.

[0137] Example 48. The chamber of Example 47, wherein the non-insufflated body cavity comprises a non-insufflated abdominal cavity, and wherein in the collapsed state, the elongated expandable body is shaped and sized to pass through an opening in the abdominal wall into the non-insufflated abdominal cavity, and wherein in the expanded state, the elongated expandable body is thin and has a surface area that is at least 5 times the surface area of ​​the elongated expandable body in the collapsed state.

[0138] Example 49. The chamber of any of Examples 36 to 48, wherein the fluid permeable wall comprises at least one membrane layer having pores with a size ranging between 0.1 μm and 100 μm.

[0139] Example 50. A fluid extraction chamber adapted for implantation into a body cavity, the fluid extraction chamber comprising:

[0140] an expandable body configured to move from a collapsed state to an expanded state when deployed in the body lumen, wherein the expandable body comprises a fluid-permeable wall defining an interior volume of the expandable body;

[0141] an outlet coupled to the expandable body, the outlet having at least one opening to the interior volume;

[0142] 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 in the circumference of the expandable body around the interior volume.

[0143] Unless otherwise defined, the meaning of all technical terms and / or scientific terms used herein is the same as that generally understood by those of ordinary skill in the art to which the present invention relates. Although materials and methods similar or equivalent to the methods and materials 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 the event of a conflict, the patent specification including the definitions shall prevail. In addition, materials, methods and examples are merely illustrative and are not intended to be necessarily restrictive.

[0144] 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. Thus, some embodiments of the present invention may take the form of a complete hardware embodiment, a complete software embodiment (including firmware, resident software, microcode, etc.) or a combination of software and hardware aspects that may be collectively referred to herein as a "circuit," "module," or "system." In addition, some embodiments of the present invention may take the form of a computer program product contained in one or more computer-readable media, wherein the computer-readable medium contains computer-readable program code. The implementation scheme of the method and / or system of some embodiments of the present invention may involve performing and / or completing selected tasks manually, automatically, or in combination thereof. In addition, the actual instruments and equipment of some embodiments of the method and / or system of the present invention may implement several selected tasks by hardware, by software, or by firmware and / or by a combination thereof, for example, using an operating system.

[0145] For example, the hardware for performing the selected tasks according to some embodiments of the present invention can be implemented as a chip or circuit. As software, the selected tasks according to some embodiments of the present invention can be implemented as multiple software instructions executed by a computer using any suitable operating system. In an exemplary embodiment of the present invention, one or more tasks according to some exemplary embodiments of the method and / or system as described herein are performed by a data processor (such as a computing platform for executing multiple instructions). Optionally, the data processor includes a volatile memory and / or non-volatile memory for storing instructions and / or data, such as a magnetic hard disk and / or removable media for storing instructions and / or data. Optionally, a network connection is also provided. Optionally, a display and / or user input device (such as a keyboard or mouse) is also provided.

[0146] Any combination of one or more computer-readable media may be used in some embodiments of the present invention. A computer-readable medium may be a computer-readable signal medium or a computer-readable storage medium. A computer-readable storage medium may be, for example, but not limited to, an electronic, magnetic, optical, electromagnetic, infrared, or semiconductor system, device, or apparatus, or any suitable combination of the foregoing. More specific examples (a non-exhaustive list) of computer-readable storage media would include the following: an electrical connection with one or more wires, a portable computer disk, 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 document, a computer-readable storage medium may be any tangible medium that can contain or store a program for use by or in conjunction with an instruction execution system, device, or apparatus.

[0147] A computer-readable signal medium may include a propagated data signal with 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 may be any computer-readable medium that is not a computer-readable storage medium and that can communicate, propagate, or transport a program for use by or in connection with an instruction execution system, apparatus, or device.

[0148] Program code embodied on a computer-readable medium and / or data used thereby may be transmitted using any appropriate medium, including but not limited to wireless, wireline, optical fiber cable, RF, etc., or any suitable combination of the foregoing.

[0149] Computer program code for performing the operations of some embodiments of the present invention can 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 can be executed entirely on the user's computer, partially on the user's computer; as a stand-alone software package, partially on the user's computer and partially on a remote computer, or entirely on a remote computer or server. In the latter scenario, the remote computer can 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 an external computer can be connected (for example, using an Internet service provider to connect via the Internet).

[0150] Some embodiments of the present invention may be described below with reference to the flowcharts and / or block diagrams of the methods, devices (systems) and computer program products according to embodiments of the present invention. It should be understood that each box in the flowcharts and / or block diagrams and the combination of boxes in the flowcharts and / or block diagrams can be implemented by computer program instructions. These computer program instructions can be provided to a processor of a general-purpose computer, a special-purpose computer or other programmable data processing device to produce a machine, so that the instructions executed by the processor of the computer or other programmable data processing device create a device for implementing the function / action specified in one or more boxes of the flowcharts and / or block diagrams.

[0151] These computer program instructions may also be stored in a computer-readable medium, which can direct a computer, other programmable data processing device or other apparatus to operate in a specific manner so that the instructions stored in the computer-readable medium produce an article of manufacture including instructions for implementing the functions / actions specified in one or more blocks of the flowchart and / or block diagram.

[0152] The computer program instructions may also be loaded onto a computer, other programmable data processing device, or other apparatus, so that a series of operating steps are executed on the computer, other programmable device, or other apparatus to produce a computer-implemented process, so that the instructions executed on the computer or other programmable device provide a process for implementing the functions / actions specified in one or more boxes of the flowchart and / or block diagram.

[0153] Some of the methods described herein are generally designed for computer use only and may not be feasible or practical for purely manual execution by a human expert. It is contemplated that a human expert wishing to manually perform similar tasks (such as determining pressure and / or changes thereto) and modifying the operation of a pump would use an entirely different approach, e.g., utilizing expert knowledge and / or the pattern recognition capabilities of the human brain, which would be much more efficient than manually going through the steps of the methods described herein. BRIEF DESCRIPTION OF THE DRAWINGS

[0154] Some embodiments of the present invention are described herein by way of example only with reference to the accompanying drawings. With specific reference now to the drawings in detail, it should be emphasized that the details are shown by way of example only and for purposes of illustrative discussion of the embodiments of the present invention. In this regard, the description provided in conjunction with the drawings will make it clear to those skilled in the art how to practice the embodiments of the present invention.

[0155] In the attached figure:

[0156] Figure 1 is a flow chart of a process for inflating an elongated fluid extraction chamber within a body cavity according to some exemplary embodiments of the present invention;

[0157] Figure 2A and 2B is a block diagram of a fluid extraction system having an elongated fluid extraction chamber in a collapsed state (e.g., in a folded state ( Figure 2A )) and the expanded state (e.g., in the unfolded state ( Figure 2B ));

[0158] Figure 2C and 2D is in a collapsed state ( Figure 2C ) and in an expanded state ( Figure 2D ) is a schematic diagram of a fluid extraction chamber;

[0159] Figure 2E and 2F According to some exemplary embodiments of the present invention Figure 2C and 2D A schematic cross-sectional view of;

[0160] Figures 2G-2I is a schematic diagram showing folding of a wall of a fluid extraction chamber (e.g., a membrane of the fluid extraction chamber) in different folding patterns, for example, to obtain collapsed and compact states of the fluid extraction chamber, according to some exemplary embodiments of the present invention;

[0161] Figure 2J and 2K is a schematic diagram of a cross-sectional view of a fluid extraction chamber in an expanded state according to some exemplary embodiments of the present invention;

[0162] Figure 3A and 3B is in a folded state ( Figure 3A ) and in the expanded state ( Figure 3B ) is a schematic diagram of a fluid extraction chamber;

[0163] Figure 3C is a schematic diagram of a chamber deployment process through two body openings according to some exemplary embodiments of the present invention;

[0164] Figure 3D is a schematic diagram of a chamber deployment process through a single body opening according to some exemplary embodiments of the present invention;

[0165] Figure 3E is a flow chart of a process for chamber deployment through two body openings according to some exemplary embodiments of the present invention;

[0166] Figure 3Fis a flow chart of a process for chamber deployment through a single body opening according to some exemplary embodiments of the present invention;

[0167] Figure 3G is a schematic diagram of a chamber deployed inside the abdominal cavity according to some exemplary embodiments of the present invention;

[0168] Figures 4A-4C is a schematic diagram illustrating expansion of a fluid extraction device using a dual-state stylet according to some exemplary embodiments of the present invention;

[0169] Figures 4D-4E is a schematic diagram of a wall of a fluid extraction device according to some exemplary embodiments of the present invention;

[0170] Figures 4F-4H is a schematic diagram of types of perforated layers in a wall of a fluid extraction device according to some exemplary embodiments of the present invention;

[0171] Figure 5A and 5B is a diagram showing a collapsed state ( Figure 5A ) and in an expanded state ( Figure 5B ) is a schematic diagram of a fluid extraction chamber having an inner hydrophobic portion;

[0172] Figure 5C is a schematic diagram of a perforated pipe according to some exemplary embodiments of the present invention;

[0173] Figure 5D and 5E According to some exemplary embodiments of the present invention Figure 5D and 5E Schematic diagram of the layers of the wall of the fluid extraction chamber shown in;

[0174] Figure 6A and 6B is a schematic diagram illustrating a fluid extraction chamber with an integrated stylet according to some exemplary embodiments of the present invention;

[0175] Figure 7 is a schematic diagram of an expandable body opening seal according to some exemplary embodiments of the present invention;

[0176] Figures 8A-8C is a schematic diagram of a fluid extraction chamber having a wall with two or more filtration stages according to some exemplary embodiments of the present invention;

[0177] Figures 9A-9C is a schematic diagram of an inlet tube for an inner cavity device having at least one additional flow path into the cavity according to some exemplary embodiments of the present invention;

[0178] Figure 10A and 10B is a schematic diagram illustrating the release of material absorbing beads into the interior lumen of a fluid extraction chamber according to some exemplary embodiments of the present invention;

[0179] Figure 10C is a schematic diagram of a cross-section of a fluid extraction chamber according to some exemplary embodiments of the present invention;

[0180] Figure 10D is a schematic diagram of a cross section formed in a fluid extraction chamber showing two portions of at least one membrane layer welded together by an intermediate porous layer along at least one seam line in a circumference of the chamber body around an inner volume of the chamber, according to some exemplary embodiments of the present invention;

[0181] Figures 11A-11D is a schematic diagram illustrating a fluid extraction chamber having an insertable flexible stent according to some exemplary embodiments of the present invention;

[0182] Figure 12A and 12B is a schematic diagram illustrating a fluid extraction chamber with an integrated flexible support according to some exemplary embodiments of the present invention;

[0183] Figure 13A is a schematic diagram illustrating a fluid extraction chamber having an integrated flexible support according to some exemplary embodiments of the present invention, wherein the integrated flexible support comprises at least two flexible stylets, wherein the at least two flexible stylets are optionally independent stylets;

[0184] Figure 13B FIG. 1 is a diagram illustrating the process of resisting pressure exerted by an organ or tissue on a fluid extraction chamber by allowing an outer stylet to flex while an inner stylet maintains the chamber's interior volume open, according to some exemplary embodiments of the present invention. Figure 13A Schematic diagram of a fluid extraction chamber;

[0185] Figures 14A-14C is a schematic diagram illustrating expansion of a fluid extraction chamber having an inner stent using an outer rod reversibly coupled to the inner stent according to some exemplary embodiments of the present invention;

[0186] Figures 14D-14G is a schematic diagram illustrating decoupling of an outer rod from an inner support of a fluid extraction chamber after expansion of the chamber according to some exemplary embodiments of the present invention;

[0187] Figures 15A-15Cis a schematic diagram illustrating expansion of a fluid extraction chamber having an internal stent using at least two external rods having distal ends positioned within an internal lumen of the fluid extraction chamber and proximal ends located outside the internal lumen according to some exemplary embodiments of the present invention;

[0188] Figures 16A-16C is a schematic diagram illustrating expansion of a fluid extraction chamber having an internal stent using at least two external rods functionally coupled to an outer surface of the fluid extraction chamber according to some exemplary embodiments of the present invention;

[0189] Figures 17A-17C is a schematic diagram illustrating the expansion of a fluid extraction chamber having an internal stent using an expansion tool including an expansion tray according to some exemplary embodiments of the present invention;

[0190] Figure 17D and 17E FIG. 1 is a diagram showing a method for moving a mobile Figures 17A-17C A schematic diagram of the mechanism of the arm of the expansion tray shown in ; and

[0191] Figure 18 is a flow chart of a process for deploying a fluid extraction chamber in a body lumen using an inflation tool, according to some exemplary embodiments of the present invention. DETAILED DESCRIPTION

[0192] In some embodiments of the present invention, the present invention relates to ultrafiltration devices and methods, and more particularly, but not exclusively, to percutaneously implantable ultrafiltration devices and methods.

[0193] An aspect of some embodiments relates to an elongated fluid extraction device, such as a chamber, that can be introduced into a non-insufflated body cavity through a small opening in a body and expanded within the non-insufflated body cavity. In some embodiments, the body of the elongated fluid extraction device, when inserted through the body opening into the non-insufflated body cavity and / or when expanded within the non-insufflated body cavity, has an aspect 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, an outlet of the elongated fluid extraction device is external to the body, optionally coupled to a vacuum generator (e.g., a pump) and / or a reservoir located external to the body. In some embodiments, the fluid extraction chamber is introduced into the non-insufflated body cavity under local anesthesia.

[0194] According to some embodiments, when inflated within a body cavity (e.g., a non-insufflated body cavity), the elongated fluid extraction device is configured to remove fluid found within the body cavity using filtration (e.g., ultrafiltration). In some embodiments, fluid within the body cavity passes through the aperture into the internal lumen of the fluid extraction device and is expelled from the patient 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, thereby causing the body cavity fluid to be drawn into the internal volume.

[0195] According to some embodiments, when expanded within a body cavity, the body of the elongated fluid extraction device bridges between two spaced-apart regions (e.g., 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 length of the body of the elongated fluid extraction device is at least 5 cm, at least 10 cm, at least 15 cm, at least 20 cm, 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, when introduced into the body cavity through the opening, the lateral expansion of the body increases the width of the body by at least two times, at least three times, at least four times, or any intermediate, smaller, or larger value relative to the width of the body in the collapsed state. 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 the collapsed state.

[0196] According to some embodiments, the elongated fluid extraction chamber is expanded within a body cavity by inserting a stylet (e.g., an inflatable stylet) from outside the body into the interior volume of the chamber. Alternatively or additionally, the chamber is expanded by inflating a stylet that is integrated with the chamber. Alternatively or additionally, the chamber is expanded by injecting 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, such as less than 1.2 mm, less than 1 mm, or any intermediate, smaller, or larger value.

[0197] According to some embodiments, a 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 maximum width of the opening formed in the body is in the range of between 1.5 mm and 12 mm, for example, in the range of between 1.5 mm and 5 mm, in the range of between 3 mm and 7 mm, in the range of between 5 mm and 10 mm, or any intermediate, smaller, or larger width range. In some embodiments, the elongated fluid extraction chamber in the collapsed state is shaped and sized to fit within the formed opening. In some embodiments, the maximum width of the chamber in the collapsed state is in the range of between 1.5 mm and 14 mm, for example, in the range of between 1.5 mm and 5 mm, in the range of between 3 mm and 7 mm, in the range of between 5 mm and 10 mm, or any intermediate, smaller, or larger width range.

[0198] A potential advantage of having an elongated inflatable fluid extraction chamber for removing fluid may be allowing a large surface area when the device is inflated within a body lumen for fluid filtration and removal, while maintaining a low profile of the chamber in the collapsed state.

[0199] A further possibility of having an elongated fluid extraction chamber for removing fluid may be to allow removal of fluid from spaced-apart areas of the body cavity.

[0200] An aspect of some embodiments relates to a fluid extraction chamber having two or more types of pores configured to open at different pressure thresholds. In some embodiments, at least one type of pore is configured to open when a pressure level within an interior volume of the fluid extraction chamber is above a pressure threshold required for the different types of pores of the device to open.

[0201] According to some embodiments, the two or more types of pores are located at different areas of the chamber, for example, on opposite sides. Alternatively or additionally, the two or more types of pores are located at the same side of the chamber. In some embodiments, each type of pore is located at a different membrane or layer of the chamber wall.

[0202] A potential advantage of having two types of pores may be to allow continued fluid filtration even if one type of pore is blocked.

[0203] An aspect of some embodiments relates to removing molecules (e.g., toxins) from fluid within a body cavity using particles (e.g., beads) introduced into the interior lumen of a fluid extraction chamber. In some embodiments, the beads are located within the interior lumen of the chamber during deployment or are introduced into the interior lumen of an already deployed chamber after deployment. In some embodiments, the beads are introduced into the interior lumen of the chamber when an increase in the concentration of one or more toxins in the body cavity fluid is indicated.

[0204] According to some embodiments, the beads are removed from the interior volume of the chamber via the chamber outlet, for example using suction. Optionally, after the beads are removed, they are replaced with new beads. Alternatively, the beads remain in the interior volume of the chamber and are removed from the body cavity as the chamber is removed.

[0205] An aspect of some embodiments relates to expanding a collapsed fluid extraction chamber having a fluid-permeable wall defining an interior volume in 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, such as a biodegradable material. In some embodiments, the biodegradable material is applied as a coating (e.g., a hydrophobic coating) on ​​the outer surface of the fluid-permeable wall. Alternatively or additionally, the biodegradable material is applied as a coating (e.g., a hydrophobic coating) on ​​the inner surface of the fluid-permeable wall.

[0206] According to some embodiments, injecting a fluid into the interior volume degrades the coating. In some embodiments, the sealant coating degrades by hydrolysis.

[0207] An aspect of some embodiments relates to treating a patient diagnosed with heart failure (e.g., chronic heart failure or acute heart failure) by introducing a fluid extraction chamber into a non-insufflated abdominal cavity. In some embodiments, the fluid extraction chamber is introduced into the non-insufflated abdominal cavity under local anesthesia. Optionally, fluid accumulation in the patient's abdominal cavity is detected prior to introducing the fluid extraction chamber. In some embodiments, the fluid extraction chamber comprises a fluid-permeable wall defining an interior volume. In some embodiments, negative pressure is applied (optionally intermittently) to the interior volume to draw fluid from the abdominal cavity into the chamber's interior volume. In some embodiments, the fluid drawn into the chamber's interior volume is removed from the patient's body via an outlet tube fluidly coupled to the interior volume.

[0208] An aspect of some embodiments relates to using an elongated expansion tool (e.g., an expander) coupled to a fluid extraction chamber to expand the chamber within a body cavity (e.g., the abdominal cavity). In some embodiments, the tool is manipulated, such as axially moved and / or rotated, from outside the body cavity (e.g., from outside the subject's body). Optionally, the tool is reversibly coupled to the chamber and configured to be decoupled from the chamber and removed from the body cavity.

[0209] According to some embodiments, the elongated expansion tool is functionally coupled to an outer surface of the chamber body. Alternatively or additionally, the elongated expansion tool is positioned within an interior volume, e.g., within an inner lumen of the chamber. In some embodiments, the elongated expansion tool is inserted into the interior volume via at least one outlet of the chamber. In some embodiments, the elongated expansion tool is coupled, optionally reversibly coupled, to a stent within the interior volume. In some embodiments, the elongated expansion tool is configured to move the stent from a collapsed state to an expanded state, e.g., by axially moving and / or rotating the elongated expansion tool to exert a force on the stent.

[0210] An aspect of some embodiments relates to forming a fluid extraction chamber body by adhering two portions of at least one membrane layer together, wherein the adhering is achieved by adhering (e.g., fixedly adhering) the two portions to at least one intermediate layer positioned therebetween. In some embodiments, adhering the two portions comprises welding and / or gluing the two portions together to the intermediate layer, e.g., to opposite sides of the intermediate layer.

[0211] According to some embodiments, the fixed adhesion of the two membrane portions forms and / or at least one seam line in the circumference of the inner volume of the chamber around the chamber. In some embodiments, the at least one intermediate layer is a porous layer, for example, does not interfere with the flow of fluid into the chamber via the membrane. Optionally, the at least one intermediate layer is a mesh layer. Optionally, the two parts of the at least one membrane layer adhere to each other via the intermediate layer (for example, via holes in the intermediate layer). In some embodiments, the adhesion of the two parts comprises adhering two separated membrane layers to the at least one intermediate layer positioned therebetween to form a closed body of the chamber with at least one outlet.

[0212] Before explaining at least one embodiment of the present invention in detail, it should be understood that the present invention is not necessarily limited in its application to the details of construction and arrangement of components and / or methods set forth in the following description and / or illustrated in the drawings and / or examples. The present invention is capable of other embodiments or can be practiced or implemented in various ways.

[0213] General methods for extracting fluid from body cavities

[0214] 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 in the body cavity. In some embodiments, the excess fluid is the result of a clinical condition associated with a disease, such as heart failure, kidney disease, nephrotic syndrome, cirrhosis of the liver, or cancer. Alternatively or additionally, the excess fluid is the result of treatment of the patient, such as a side effect, such as an excessive diuretic that may cause further renal deterioration or certain discectomies. In some embodiments, the fluid insertion chamber is introduced into the body cavity via a small incision in the body formed under local anesthesia. In some embodiments, the size of the incision formed in the patient's body is in the range of 3mm-15mm, such as 3mm-7mm, 5mm-10mm, 5mm-15mm, or any intermediate, smaller, or larger value range. Optionally, the incision in the body is further dilated to a width value in the range of 6mm-30mm, for example, 6mm-12mm, 10mm-17mm, 13mm-20mm, 17mm-30mm or any intermediate, smaller or larger value range.

[0215] According to some exemplary embodiments, the extraction chamber is part of a system for filtration (e.g., for ultrafiltration of fluid in or through a body cavity). As used herein, ultrafiltration refers to the extraction of fluid through at least one body membrane under a hydrostatic pressure or concentration (osmotic / colloid osmotic) gradient and filtration through at least one semipermeable membrane. In some embodiments, the outlet of the chamber extends out of the patient's body, for example, through an incision for introducing the chamber into the body cavity.

[0216] According to some exemplary embodiments, when the outlet is located outside the body, the fluid extraction chamber remains within the body cavity for a period of time ranging from 1 hour to 2 months, for example, 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 of time. In some embodiments, when the fluid level inside the body cavity drops below a predetermined value, the fluid extraction chamber is removed from the body cavity and optionally replaced. Alternatively or additionally, when the filtration efficiency drops below a predetermined value, the fluid extraction chamber is removed from the body cavity and optionally replaced. Alternatively, the fluid extraction chamber is implanted into the patient's body together with the outlet of the chamber and, optionally, a pump, the pump being configured to generate a negative pressure and apply a negative pressure to the internal volume of the fluid extraction chamber.

[0217] According to some exemplary embodiments, the fluid extraction chamber is part of a fluid extraction system comprising a chamber, a pump and a control unit, and the fluid extraction system can be fully implantable, for example in a chronic patient, for example in a patient with chronic heart failure. Alternatively, the system can be partially implantable, for example, the pump and the control unit are located outside the body of the patient (for example, a patient diagnosed with acute heart failure). In some embodiments, in a partially implantable configuration, the chamber is located inside the body and the outlet of the pump and / or chamber is located outside the patient's body. In some embodiments, for example, such as in cancer patients and / or in patients with chronic kidney disease, only the chamber is implanted, while the pump, control unit and outlet of the chamber are located outside the patient's body.

[0218] Now refer to Figure 1 , which depicts filtering fluid from a body cavity according to some exemplary embodiments of the present invention.

[0219] According to some exemplary embodiments, excess systemic fluid is identified at block 102, optionally systemically in the body or locally in a cavity (e.g., the pleural cavity of a subject). In some embodiments, fluid is identified using an imaging system (e.g., an x-ray or ultrasound imaging system). Alternatively, fluid overload is identified by performing a physical and / or biochemical examination of the patient.

[0220] According to some exemplary embodiments, a patient is locally anesthetized at block 102. In some embodiments, local anesthesia is delivered to the patient near or at a selected location to form an opening in the abdominal wall suitable for inserting a fluid extraction chamber into the patient's abdominal cavity.

[0221] According to some exemplary embodiments, at block 106, an opening is formed in the abdominal cavity. 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 between 3 mm and 15 mm, for example, in the range of between 3 mm and 8 mm, in the range of between 3 mm and 8 mm, in the range of between 8 mm-15 mm, or any intermediate, smaller, or larger range of values. Optionally, the opening is formed prior to the laparoscopic procedure.

[0222] According to some exemplary embodiments, at frame 108, the elongated extraction chamber in a collapsed state is introduced into the body cavity. In some embodiments, the elongated extraction chamber is introduced through an opening formed at frame 106. In some embodiments, a flow path (e.g., a channel) including an outlet of the extraction chamber is left outside the patient's body. In some embodiments, during insertion, the elongated extraction chamber is rigid in an axial direction (e.g., in the direction of the long axis of the chamber). In some embodiments, the rigidity allows, for example, to assist in the insertion process through a small incision, optionally without bending the chamber. In some embodiments, the chamber is rigid by placing a sleeve (e.g., a sheath, optionally a rigid sleeve) around the body of the chamber in the collapsed state.

[0223] According to some exemplary embodiments, at frame 110, once the chamber is located within the abdominal cavity, the chamber is expanded to obtain an expanded state. In some embodiments, the chamber is expanded by introducing a stylet into the internal volume of the chamber from outside the body. Alternatively, the chamber is expanded by expanding a stylet (e.g., a dual-state stylet having a collapsed state and an expanded state within the internal lumen of the chamber). Optionally, an expandable stylet is integrated into the body of the chamber. Optionally, the chamber expands when a dissolvable sleeve (e.g., a dissolvable sheath) dissolves within the body cavity. In some embodiments, the dissolution of the sheath, which optionally applies force against the expandable stylet, causes the stylet to expand.

[0224] According to some exemplary embodiments, the chamber is expanded by introducing fluid from outside the body into the interior lumen of the chamber. In some embodiments, when fluid is introduced into the interior lumen, the hydrophobic core (e.g., the hydrophobic inner layer of the chamber wall) causes the chamber to expand.

[0225] According to some exemplary embodiments, at block 112, the fluid is filtered. In some embodiments, a vacuum is applied to the interior volume of the chamber, causing the fluid to pass from the body cavity through the pores in the chamber wall into the interior volume of the chamber. In some embodiments, the suction force generated 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).

[0226] According to some exemplary embodiments, the filtering at block 112 is performed until the pores of the chamber are blocked, thereby causing an increase in the applied vacuum force and / or a decrease in the flow of fluid through the chamber outlet. Optionally, during the filtering at block 112, when the applied vacuum force is above a threshold level, at least one additional set of pores is opened, thereby causing an increase in the flow of fluid through the outlet and optionally causing a decrease in the applied vacuum force.

[0227] According to some exemplary embodiments, optionally, at block 114, the elongated chamber filters fluid from two spaced-apart regions in the body cavity. Optionally, the elongated chamber bridges between the two spaced-apart regions of the body cavity.

[0228] According to some exemplary embodiments, once filtration stops, at frame 118, device is optionally removed from main body. In some embodiments, device is removed by removing the internal hardening extension stylet and retrieving the loosened device from a given cavity, optionally using an outlet conduit as a service channel. Alternatively, a pre-inflated locking balloon is deflated to allow the entire device to be retrieved. Alternatively, the mechanical state of the extension stylet is changed by releasing the extension stylet from its flexed position or by using cold infusion to reduce the hardness of the device skeleton or the extension stylet. In some embodiments, device is removed when the amount of fluid in the body cavity is lower than a predetermined value, and / or when the hole of the device is blocked and filtration is not efficient. Optionally, if necessary, the device is replaced with a new device to continue filtration.

[0229] According to some exemplary embodiments, a system comprising the device may optionally be implanted at block 116. In some embodiments, if long-term fluid removal is desired, a system comprising the device and at least one pump is optionally implanted, e.g., for a period of time greater than one week, e.g., for a period of time greater than 2 weeks, 3 weeks, 1 month, or any intermediate, shorter, or longer period.

[0230] Exemplary Fluid Extraction Chambers and Systems

[0231] 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 permeate the interior lumen of the fluid extraction chamber through the pores of the chamber and are expelled from the body.

[0232] Now refer to Figure 2A and 2B , which depict a fluid extraction chamber and a fluid extraction system, respectively, according to some exemplary embodiments of the present invention.

[0233] According to some exemplary embodiments, the fluid extraction chamber 202 comprises an elongated body 204 having an interior volume 206 defined by a wall 208 of the elongated body 204. In some embodiments, the wall 208 comprises one or more layers of membrane having one or more types of pores. In some embodiments, the one or more pore types have a size in the range of 0.1 μm (micrometer) to 0.5 μm, 0.5 μm to 10 μm, or 10 μm-100 μm for small, medium, or large, respectively. Optionally, the wall 208 comprises two or more types of membrane, each having pores of different sizes, such as a first type of pores in the range of 0.1 μm-0.5 μm and a second type of pores in the range of 0.5 μm-10 μm or 10 μm-100 μm. Alternatively, the membrane can be hydrogel-type or bio-based, such as collagen. In some embodiments, the outer layer promotes tissue embedding and revascularization on the outer layer, wherein the inner layer remains impermeable to the tissue. Alternatively, each membrane can be positioned in different parts of the wall, thereby achieving different fluid filtration rates. Optionally, each membrane can be actuated individually to adapt to various physiological conditions. In certain embodiments, each membrane in the membrane is characterized by different structures or hydrophilicity while being constructed with the same porosity range.

[0234] 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 cells and tissue to grow on the outer surface of the chamber. In some embodiments, one or more inner layers of the wall (e.g., a layer facing the interior volume) prevent tissue and cells from growing and / or infiltrating into the interior volume.

[0235] 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 in a body cavity, a vacuum is applied to interior volume 206 via outlet 210, thereby generating a negative pressure in interior volume 206 and drawing fluid from the body cavity into interior volume 206 through the pores in wall 2087 and out of the body via outlet 210.

[0236] According to some exemplary embodiments, chamber 202 optionally includes a stylet 212, optionally a resilient stylet, located 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 pushes against the inner surface of wall 208, causing body 204 to expand. In some embodiments, stylet 212 is integrated into body 204. Alternatively, stylet 212 can be inserted into interior volume 216 or wall 208 from outside the patient's body, optionally through outlet 210, for example, into a circumferential channel in wall 208.

[0237] According to some exemplary embodiments, when expanded, the stylet 212 is configured to expand the body 204 to acquire any shape, e.g., a polygonal shape, a diamond shape, a triangular shape, optionally depending on the shape of the stylet 212 in the expanded state. In some embodiments, the stylet is pre-formed to acquire a specific shape when expanded, e.g., when the stylet is a dual-state stylet configured to move from a collapsed, compact, elongated shape to a pre-formed shape when expanded. Optionally, the stylet 212 (e.g., an integrated stylet) is formed from a shape memory alloy (e.g., Nitinol).

[0238] According to some exemplary embodiments, for example Figure 2A , in the collapsed state, the body 204 is placed within a sheet of material (e.g., a sheath 214). In some embodiments, the sheath 214 is configured to maintain the body 204 in the collapsed state (e.g., a folded state), optionally by exerting a mechanical force on the outer layer of the wall 208 in a direction toward the center of the interior volume 206. Optionally, the force exerted is equal to or greater than the force exerted by the stylet 212 on the inner surface of the wall 208.

[0239] According to some exemplary embodiments, for example Figure 2A As shown in FIG, 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 in the range of 10 cm to 28 cm, for example, 10 cm-20 cm, 15 cm-25 cm, 17 cm to 28 cm, or any intermediate, smaller, or larger value range. In some embodiments, in the collapsed state, the maximum width 222 of the body 204 (optionally the minor axis of the body) is in the range of 6 mm-15 mm, for example, 6 mm-10 mm, 8 mm-12 mm, 10 mm-15 mm, or any intermediate, smaller, or larger value range.

[0240] According to some exemplary embodiments, for example Figure 2BAs shown in , in the expanded state, the body 204 optionally expands laterally. In some embodiments, the expansion of the body 204 increases the maximum width 222. In some embodiments, in the expanded state, the maximum width 222 is in the range of 5 cm-20 cm, for example, 8 cm-16 cm, 5 cm-15 cm, 10 cm-20 cm, or any intermediate, smaller, or larger range of values. In some embodiments, in the expanded state, the maximum width 222 increases by at least 1.5 times, for example, 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 ratio of increase, compared to the maximum width 222 when the body is collapsed. Optionally, in the expanded state, the length 220 changes at a ratio between 1-1.5 compared to the length 220 in the collapsed state.

[0241] According to some exemplary embodiments, after expansion, the 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 range. In some embodiments, the body in the expanded state has an aspect ratio of width to length of at least 1:1.2, e.g., a ratio of at least 1:1.4, a ratio of at least 1:1.8, a ratio of at least 1:2, or any intermediate, smaller, or larger value. In some embodiments, the thickness, optionally the minimum thickness of the body 202 in the expanded state (e.g., Figure 2F The thickness 261) shown in is less than 5 mm, for example, less than 4 mm, less than 3 mm, less than 2 mm, less than 1 mm, or any intermediate, smaller or larger value.

[0242] According to some exemplary embodiments, body 204 expands, eg, when stylet 212 is moved to the expanded state, pushing against the inner surface of wall 208. In some embodiments, body 204 expands when sheath 214 is dissolved, eg, by fluid in a body cavity.

[0243] According to some exemplary embodiments, when a fluid is introduced into the interior volume 206 via the outlet 210, the body 204 expands, thereby inflating the body 204. Optionally, at least one inner layer of the wall 208 facing the interior volume 206 is coated with or comprises a hydrophobic material, optionally a biodegradable hydrophobic material, for example, polylactic acid (PLA, PDLA, PLLA), poly (lactic acid)-poly (glycolide) (PLGA), polyglycerol-sebacate (PGS) or a coating based on soluble glucose / glycogen. In some embodiments, when a fluid is introduced into the interior volume 206, two opposing hydrophobic portions of the wall repel the introduced fluid, causing the body 204 to expand outwardly away from the fluid in the interior volume. Alternatively, the expansion of 204 is achieved by injecting the fluid at a high speed through 210 at a flow rate higher than that of the wall 208, causing the body 204 to expand to its preformed or skeletal support form.

[0244] Alternatively or additionally, when the chamber 202 does not include an integrated stylet 212, the stylet is pushed into the interior volume 206 via at least one flow path in the outlet 210, thereby causing the body 204 to expand. In some embodiments, the body 204 expands by expanding or spreading the body 204 (e.g., a membrane forming the wall 208 of the body). 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.

[0245] According to some exemplary embodiments, chamber 202 comprises a resilient support structure 213, e.g., an elastomeric skeleton, which is optionally porous within the chamber's interior volume 208. In some embodiments, the support structure comprises a mesh or sponge and is configured to contact the inner surface of wall 208. In some embodiments, support structure 213 is compressed when body 206 is in the expanded state, and expands when body 206 is in the expanded state. In some embodiments, during activation of the chamber and after deployment of chamber 202, support structure 213 is configured to maintain body 202 at least partially expanded along at least 30% of the length 220 of body 204 (e.g., at least 50% along the length of the body, at least 60% along the length of the body, at least 80% along the length of the body, or any intermediate, smaller, or larger percentages), e.g., by preventing wall 208 from collapsing onto interior volume 206.

[0246] According to some exemplary embodiments, the support structure fills at least 30% of the interior volume 216 of the body 204, for example, 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 larger percentage of the interior volume.

[0247] 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 are of similar size or of variable size. In some embodiments, the pores are uniformly or randomly distributed throughout support structure 213. In some embodiments, support structure 213 comprises one or more layers of a material having a mesh, net, or sponge structure. Optionally, at least a portion of the support structure comprises an auxetic structure and / or auxetic material configured to allow support structure 213 to expand when the support structure is stretched.

[0248] According to some exemplary embodiments, the elongated body 204 has a tubular shape (eg, a cylindrical elongated shape) in both the collapsed state (eg, a folded state) and the expanded state (eg, an unfolded or spread out state).

[0249] According to some exemplary embodiments, in the expanded state, the membrane-containing wall 208 is flat, optionally substantially flat along, for example, at least 80%, along at least 85%, along at least 90%, along 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, for example, 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, for example, 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 2 , for example, at least 300cm 2 , at least 400cm 2 , at least 500cm 2 or any intermediate, smaller, or larger value.

[0250] According to some exemplary embodiments, for example Figure 2B As shown in FIG, a system for fluid extraction (e.g., system 223) includes a chamber 202 and a control unit 225. In some embodiments, the control unit 225 includes a vacuum generator (e.g., pump 224) coupled to the outlet 210 and configured to apply a vacuum (e.g., negative pressure) to the interior volume 206 via the outlet 210 (e.g., via at least one channel in the outlet 210).

[0251] According to some exemplary embodiments, control unit 225 includes a memory 226 that stores at least one activation protocol for the pump and / or one or more parameter values ​​for the applied vacuum, for example, the timing of the application of the vacuum and the vacuum level applied by pump 224 to interior volume 206. In some embodiments, control unit 225 includes control circuitry 228 that is configured to control the activation of the pump, optionally based on the at least one activation protocol and / or parameter values ​​stored in memory 226.

[0252] According to some exemplary embodiments, the control unit 225 includes at least one sensor 230. In some embodiments, the at least one sensor 230 includes a pressure sensor configured to measure the pressure inside the interior volume 206, for example, by measuring the pressure inside the outlet 210. Alternatively or additionally, the at least one sensor 230 includes a flow sensor configured to measure the flow rate of the fluid flowing out of the interior volume 206 via the outlet 210.

[0253] According to some exemplary embodiments, the end 232 (e.g., the proximal end) of the outlet 232 is optionally coupled to an external chamber configured to store fluid extracted from the patient's body via the outlet 110. Optionally, the control unit includes a power source (e.g., a battery) configured to provide power for activation of the pump 224. Optionally, the control unit is enclosed in a housing configured to be implanted in the patient's body. In some embodiments, the housing is thin and has a flat surface.

[0254] According to some exemplary embodiments, the control unit 225 is configured to be fully implanted, partially implanted, or external.

[0255] According to some exemplary embodiments, the control circuit system 228 is configured to intermittently activate the pump 224 in the interval between two consecutive activation stages, wherein no pressure is applied to the internal volume of the chamber. In some embodiments, the control circuit system 228 is configured to activate the pump 224 for a short period of time shorter than 15 seconds, for example, shorter than 12 seconds, shorter than 10 seconds, shorter than 8 seconds or any intermediate, shorter or longer time period. In some embodiments, the interval duration between two consecutive activation periods is in the range of 20 seconds and 360 seconds, for example, in the range between 20 seconds and 40 seconds, in the range between 60 seconds and 300 seconds or any intermediate, smaller or larger value range. In such and other embodiments, the control unit 225 optimizes the interval timing based on the compression and recoil dynamics of the skeleton 213, thereby optimizing the net drained volume. Optionally, the skeleton 213 is configured to, when stopping applying negative pressure, help the body recoil into an expanded state by elastically expanding the inner surface of the body and applying force to the inner surface. In some embodiments, the skeleton 213 is configured to allow controlled and / or regulated compression of the chamber body when a vacuum is applied, and to allow controlled and / or regulated recoil of the chamber body back to an expanded state when the application of the vacuum is stopped, for example during an interval period.

[0256] 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 the gears (optionally one or more cogs of the gears) can remove proteins and / or other aggregates from the fluid, thereby reducing the risk of clogging the tubing and / or pump.

[0257] Alternatively, the pump comprises at least one of a membrane pump, a piston pump, and / or a screw pump. In some embodiments, the pump comprises mechanically or electrically activated valves at the inlet and outlet ends of the pump. Alternatively, the electrically controlled valves are implemented as pipe clamps or clamping elements.

[0258] Example chamber with a foldable body

[0259] Now refer to Figures 2E-2F , which depicts a chamber having a body in a folded state and an unfolded expanded state according to some exemplary embodiments of the present invention.

[0260] According to some exemplary embodiments, for example Figure 2C , chamber 250 is in a collapsed state. In some embodiments, body 252 is coupled to outlet 254 and is in a collapsed state, eg, a folded state, within sleeve 256 that acts as a sheath.

[0261] According to some exemplary embodiments, for example Figure 2EAs shown in , which is a cross-section along axis AA of chamber 250, the body 252 is folded within the sleeve 256 so that the internal support structure 258 is compressed and optionally folded, and a tube 260 (e.g., a window-like tube, also referred to herein as a perforated tube) passes through the internal volume 262 of the body 252.

[0262] According to some exemplary embodiments, for example Figure 2D and 2F , in the expanded state, the body 252 is in the expanded state, and the support structure 258 expands. Additionally, a flexible stylet 264 is positioned within the interior volume 262, for example to keep the 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, expanded state. Optionally, the wall is formed by two or more layers (e.g., layers 268 and 270). Optionally, each layer in the layers has different fluid permeabilities and / or different rigidities.

[0263] According to some exemplary embodiments, for example Figures 2G-2I As shown in , when the chamber is in a collapsed state, the fluid permeable wall of the chamber comprising a porous membrane is configured to be folded in different ways to achieve compact packaging of the chamber. In some embodiments, the membrane folding allows, for example, to allow a minimum profile while preventing mechanical damage to the membrane.

[0264] Now refer to Figure 2J , which depicts a side view of a fluid extraction chamber body in an expanded state according to some exemplary embodiments of the present invention.

[0265] According to some exemplary embodiments, a body 270 of a fluid extraction chamber in an expanded state comprises a wall 272 defining an interior volume 274 (e.g., an inner lumen), and at least one inner tube 276 positioned within the interior volume 274, optionally surrounded by the wall 272. In some embodiments, the at least one inner tube 276 is used to drain fluid from the interior volume 274 of the chamber body. Optionally, the at least one inner tube 276 comprises a plurality of apertures along the length of the inner tube 276. In some embodiments, the body comprises a support structure, e.g., an expandable stent, instead within the interior volume 274. In these embodiments, the inner tube 276 is optional.

[0266] According to some exemplary embodiments, the body 270 of the fluid extraction chamber is thin in an expanded state and optionally has a foil-like cross-section along a majority of the total width 278 or surface area of ​​the chamber body 270 , optionally before pressure is applied in the interior volume 274 .

[0267] In some embodiments, the maximum thickness 279 of the body 270 is at most 3 mm, e.g., at most 2 mm, at most 1 mm, at most 0.7 mm, or any intermediate, smaller, or larger value, along at least 90% of the total width 278 or surface area of ​​the chamber body 270, along at least 95% of the width 278 or surface area of ​​the chamber body 270, along at least 98% of the width 278 or surface area of ​​the chamber body 270, or any intermediate, smaller, or larger percentage value. In some embodiments, the thickness 280 of the body 270 in the portion 282 of the body containing the tube 276 is in a range between 2 mm and 8 mm, e.g., between 2 mm and 4 mm, between 3 mm and 6 mm, or any intermediate, smaller, or larger value.

[0268] According to some exemplary embodiments, for example Figure 2K As shown in FIG, during active fluid extraction, fluid enters the interior volume 274 via the membrane in the wall 272 at a thinner portion of the body 270 where the maximum thickness is at most 3 mm.

[0269] Exemplary Chamber Implantation

[0270] According to some exemplary embodiments, the elongated chamber is introduced into a body cavity, such as the abdominal cavity, in a collapsed state (eg, folded state) via one or two openings in the wall of the body cavity.

[0271] Now refer to Figure 3A and 3B , which depicts a device in a state during implantation according to some exemplary embodiments of the present invention Figure 3A The collapsed state and Figure 3B The fluid extraction chamber is in an expanded state.

[0272] According to some exemplary embodiments, for example Figure 3A , the elongated fluid extraction chamber 302 is shown in a folded state, optionally within a sheet (e.g., a sheath). In some embodiments, the sheet optionally increases the stiffness of the chamber 302 in the axial direction, e.g., to facilitate insertion of the chamber 302 through an opening in the body, and / or to prevent unwanted expansion, e.g., expansion of the chamber 302 outside the body.

[0273] According to some exemplary embodiments, a non-traumatic needle (e.g., a Veress needle, e.g., a spring-activated Veress needle) or a dilator is first introduced through the abdominal wall, e.g., to create a percutaneous path into the abdominal cavity. In some embodiments, a trocar (e.g., a tunneling trocar 304) is used that slides over a guide wire 306 to enlarge the opening in the abdominal cavity. In some embodiments, a torque (e.g., a connector between a guide wire and a tube) is coupled to the outlet 310 of the chamber 302, which is used to guide the chamber 302 into the abdominal cavity via the guide wire 306. In some embodiments, e.g., Figure 3B , the guidewire 306, trocar 304, and torquer are detached from the chamber 302 during or prior to deploying the chamber 302. In some embodiments, one or more fixation wires 312 are coupled to the chamber 302. In some embodiments, the wires 312 are configured to remove the chamber 302 from the abdominal cavity and / or to secure the chamber 302 within the abdominal cavity. In some embodiments, a set of guidewires, introducers, and dilator shafts are introduced without the use of a tunneling trocar, wherein a second percutaneous entry is facilitated by a secondary incision and, optionally, by grasping the axial guidewire during a dual entry procedure, such as in FIG. Figure 3C As shown in .

[0274] According to some exemplary embodiments, the elongated chamber is configured to be inserted into the abdominal cavity using two openings in a double entry procedure, e.g. Figure 3C Now refer to Figure 3E , which depicts a procedure for inserting a chamber into the abdominal cavity using a double entry procedure according to some exemplary embodiments of the present invention.

[0275] According to some exemplary embodiments, at block 320, a passageway is formed to the cavity in two locations. In some embodiments, Figure 3C The positions (i) and (e) shown in FIG form a passage to the cavity.

[0276] According to some exemplary embodiments, at block 322 , a guidewire is passed from site (i) to the contralateral side (e).

[0277] According to some exemplary embodiments, at block 324 , a device (eg, a chamber) is connected to the wire.

[0278] According to some exemplary embodiments, at block 326 , a wire is pulled from position (e) to guide the chamber into the cavity.

[0279] According to some exemplary embodiments, at block 328, a sleeve, such as a sheath, surrounding the chamber in the collapsed state is pulled outward from the entry site (i).

[0280] According to some exemplary embodiments, at box 330, the chamber is optionally expanded by injecting fluid into the internal volume of the device and / or by inserting an expansion tube needle (e.g., a tube needle frame) and / or by changing the positioning of an internally embedded frame or skeleton or by various methods described in this application.

[0281] According to some exemplary embodiments, at block 332 , a stylet frame used to expand the body of the chamber (eg, body 204 or 302 ) is locked, optionally to attach the body in a final form, such as an expanded form.

[0282] According to some exemplary embodiments, at block 334, the procedural accessories are removed: wires, tunneling guidewires or trocars, and sutures.

[0283] According to some exemplary embodiments, the elongated chamber is configured to be inserted into the abdominal cavity using a single opening in a single entry procedure, e.g. Figure 3D Now refer to Figure 3F , which depicts a procedure for inserting a chamber into the abdominal cavity using a single entry procedure according to some exemplary embodiments of the present invention.

[0284] According to some exemplary embodiments, at block 340 , a single access site to the cavity is formed.

[0285] According to some exemplary embodiments, at block 342 , a sheath and / or guidewire is positioned within the access site.

[0286] According to some exemplary embodiments, at block 344, the device is pushed through the sheath and / or guidewire into the lumen.

[0287] According to some exemplary embodiments, at block 346, a sheath, such as a sleeve surrounding the chamber, is removed outwardly through the access site. Alternatively, the sheath is resolved.

[0288] According to some exemplary embodiments, at block 348 , the chamber is expanded, optionally by injecting a fluid into the interior volume of the chamber.

[0289] According to some exemplary embodiments, at block 350 , the stylet and / or frame is locked, as described at block 332 .

[0290] According to some exemplary embodiments, at block 352 , wires and / or other components used to insert into the chamber are removed, as described at block 334 .

[0291] According to some exemplary embodiments, an exit channel (eg, exit 210 or 310 ) is optionally tunneled subcutaneously, for example, to better secure the device in place.

[0292] According to some exemplary embodiments, for example Figure 3G , the chamber 302 is implanted in an expanded state within the abdominal cavity 360 inside the peritoneal cavity 362. In some embodiments, the implanted chamber contacts two or more regions within the abdominal cavity 360 (e.g., regions 364, 366, 368, 370, and 372 spaced apart within the peritoneum 362). A potential advantage of having an elongated chamber in an expanded state is that it can allow for aspiration of fluid accumulated in different and spaced apart regions of the peritoneum or peritoneal cavity (e.g., Figure 3G 364, 366, 368, 370, and 372) shown in FIG.

[0293] Exemplary Dual-State Stylet

[0294] According to some exemplary embodiments, a fluid extraction chamber is expanded within a body lumen using a dual-state stylet (e.g., a bistable stylet) that is a stylet that can move between a collapsed state having a low profile suitable for insertion into a chamber in the collapsed state and an expanded state that allows the chamber to be expanded within the body lumen. 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).

[0295] Now refer to Figures 4A-4C , which depicts the expansion, eg, deployment, of a fluid extraction chamber using a dual-state stylet according to some exemplary embodiments of the present invention.

[0296] According to some exemplary embodiments, for example Figure 4A , chamber 402 (optionally in the form of a balloon) is in a collapsed state within sheath 404. In some embodiments, the chamber comprises at least one (e.g., a single) flow path into and out of the chamber, such as outlet 401. In some embodiments, when chamber 402 is introduced into a body cavity through an opening, such as Figures 3A-3F As shown in FIG. 4 , the bistable stylet 403 is introduced into the chamber 402 through the outlet 401 , for example into the interior volume of the chamber.

[0297] According to some exemplary embodiments, for example Figure 4B As shown in FIG, a sheath 404, which optionally prevents the chamber from expanding, is removed. In some embodiments, the sheath 404 is dissolved by the fluid in the body cavity. Alternatively or additionally, the sheath 404 is dissolved by fluid injected into the interior volume of the chamber or the body cavity from outside the body. In some embodiments, the sheath 404 is removed from the body through the same opening used to insert the chamber into the body cavity or through a different opening.

[0298] According to some exemplary embodiments, for example Figure 4CAs shown in FIG, when the sheath 404 is removed, the bistable stylet 403 optionally expands laterally (e.g., sideways) within the chamber 402 and pushes against the inner surface of the chamber wall. In some embodiments, the expansion of the stylet causes the chamber 402 to expand to an expanded state. In some embodiments, for example, Figure 4C As shown in , in the expanded state, the chamber body is narrow and has at least two flat surfaces, and the at least two flat surfaces are coated with or include a porous membrane. Optionally, the at least two flat surfaces are planar. In some embodiments, the flat surface is a surface having a protrusion extending from the surface, and the length of the protrusion is less than 2 mm, for example, less than 1 mm, less than 0.5 mm, or any intermediate, smaller or larger value.

[0299] Now refer to Figure 4D and 4E , which depicts the composition of the walls of a chamber according to some exemplary embodiments of the present invention.

[0300] According to some exemplary embodiments, for example Figure 4E As shown in FIG, the wall of chamber 402 comprises inner and outer layers of permeable membrane 421, and an inner core layer 423 of perforated medium having fixed or variable spacing. In some embodiments, at least one additional support layer 422 is located between the inner membrane layer 421 and the inner core layer 423 and between the outer membrane layer 421 and the inner core layer 423.

[0301] According to some exemplary embodiments, for example Figure 4F As shown in FIG, the core layer 423 is formed by a mesh 430 having fixed spacings 432. Alternatively, for example, Figure 4G and 4H As shown in FIG, core layer 434 includes cutouts 436 or openings in variable locations (4G), or core layer 436 includes openings 440 at different locations and of different sizes. In some embodiments, the core layer is a polymer layer.

[0302] Fluid extraction chamber with hydrophobic core

[0303] According to some exemplary embodiments, the fluid extraction chamber comprises a wall having a hydrophobic layer configured to facilitate expansion of the chamber within a body cavity.

[0304] According to some exemplary embodiments, the inner layer of degradable hydrophobic coating allows to inflate the chamber by injecting fluid. In certain embodiments, this allows to prevent that permeable membrane itself expands and damages due to the blowing-in of fluid. In certain embodiments, once device is inflated, after hydrophobic core is absorbed by fluid, extension stylet is inserted to keep the shape of device. Optionally, device positioning is completed via double pull-pull wire mechanism, and described double pull-pull wire mechanism also allows to optionally pull open sheath. In certain embodiments, the hydrophobic layer of wall allows to use the fluid injected into the internal volume by outlet to initially expand the chamber, without the risk that injected fluid will flow out by the hole in wall (for example, by the hole of the film in wall). In certain embodiments, once hydrophobic layer degrades, stylet is introduced into the chamber, so that chamber is maintained at a stable expanded state.

[0305] A potential advantage of using a fluid to initially inflate the chamber may be allowing the insufflation fluid to expand uniformly in all directions, which allows the shape of the inflated chamber to be optionally tailored to a space within a body cavity, such as a space between organs.

[0306] According to some exemplary embodiments, a chamber having a hydrophobic core is used to enable efficient expansion of the folded device to its final form with minimal use of metallic skeleton parts (eg, stylets).

[0307] Now refer to Figures 5A-5C , which depicts a chamber with a hydrophobic core according to some exemplary embodiments of the present invention.

[0308] According to some exemplary embodiments, chamber 502 comprises a body having a filter capsule 504 coupled to port 506. In some embodiments, for example Figure 5A , chamber 502 is shown in a collapsed state within a sleeve (e.g., sheath 508, optionally a dissolvable sheath). In some embodiments, wire 510 is coupled to sheath 508, e.g., to facilitate or allow removal of sheath 508 when chamber 502 is within a body cavity. Optionally, wire 512 is coupled to chamber 502, optionally near or to an exit of the chamber, e.g., to allow for securing chamber 502 after deployment.

[0309] According to some exemplary embodiments, for example Figure 5B , which is a cross-section of chamber 502, chamber 502 includes a tube (e.g., perforated tube 514) that passes through an outlet into the interior volume of the chamber (e.g., the interior volume of filtration capsule 504). In some embodiments, during deployment, a stylet 516 is pushed through outlet 506 into chamber 502. In some embodiments, the stylet is pushed into the interior volume of filtration capsule 504, optionally into a circumferential channel in the wall of the capsule.

[0310] According to some exemplary embodiments, for example Figure 5D and 5E As shown in FIG, the wall 520 of the filtration capsule is composed of two layers: an outer layer 522 of a permeable membrane and an inner support layer 524 containing a hydrophobic coating (e.g., a resorbable hydrophobic coating), for example to allow initial expansion. Alternatively, only the inner layer, which is made of a stronger and harder material and structure than the outer layer, is coated with the resorbable hydrophobic coating. In some embodiments, these layers are connected at at least some points of the body or along its periphery and thus move together with the inflation of the fluid.

[0311] According to some exemplary embodiments, to inflate a chamber 502 (e.g., a filter capsule 504 within a body cavity), the sheath 508 is removed and a fluid is injected into the interior volume of the filter capsule between the inner layer 524 having the hydrophobic coating via the tube 514. In some embodiments, the injected fluid repels the hydrophobic layer and inflates the filter capsule. In some embodiments, the support layer within the wall of the chamber or within the interior volume comprises two compartments: at least one compartment shaped and sized to receive a stylet, or alternatively, comprising an integrated stylet; and optionally at least one additional compartment comprising the perforated tube 514.

[0312] Exemplary fluid extraction chamber with integrated channels

[0313] According to some exemplary embodiments, the fluid extraction chamber comprises a body, such as a filtration capsule, having integrated channels within the interior volume of the body. In some embodiments, the integrated channels (e.g., integrated drain channels) allow, for example, a large aspect ratio while maintaining multiple drain channels within the device to optionally overcome local collapse without having an internal collection tube, such as Figure 5A and 5B Tube 514 shown in .

[0314] According to some exemplary embodiments, a chamber with an integrated stylet and integrated channels allows, for example, ensuring effective fluid passage from all areas of the chamber, even in the event of localized blockage or collapse.

[0315] Now refer to Figure 6A and 6B , which depicts a fluid extraction chamber with an integrated exhaust path according to some exemplary embodiments of the present invention.

[0316] According to some exemplary embodiments, for example Figure 6A, chamber 602 comprises a body, such as a filtration capsule 604, coupled to an outlet 606. In some embodiments, chamber 602 comprises an integrated stylet 608 that is configured to expand when a sheath surrounding chamber 602 is removed or dissolved. In some embodiments, the wall of the chamber comprises a permeable medium with an integrated fluid delivery channel 610.

[0317] According to some exemplary embodiments, for example Figure 6B , chamber 610 includes a filter capsule 612 coupled to an outlet 614, the filter capsule being optionally shaped as a capsule. In some embodiments, an elastic support structure (e.g., a permeable skeleton mesh 616) present in the inner volume of the chamber enclosed by the wall of the chamber and providing mechanical support against the applied vacuum is included in a plurality of integrated channels 618 that converge at the outlet 614. In some embodiments, the chamber includes an integrated stylet, such as an expandable stylet, located within the wall of the chamber. Alternatively, in order to deploy and expand the chamber within the body cavity, an expandable stylet (e.g., an elastic stylet) is introduced into the wall of the chamber, optionally into a dedicated channel in the wall.

[0318] Exemplary seals

[0319] According to some exemplary embodiments, to extract fluid, a vacuum is applied from outside the body to the interior volume of a fluid extraction chamber via an outlet that exits the body cavity through an opening in a wall of the body (e.g., an opening in the abdominal wall). In some embodiments, the vacuum creates a negative pressure within the interior volume that applies suction to the fluid within the body cavity, thereby causing the body cavity fluid to flow into the interior volume of the chamber. In some embodiments, a seal in the abdominal wall opening is used to prevent the vacuum and suction from leaking through the abdominal wall opening and / or through gaps between the outlet tube and the tissue of the abdominal wall opening.

[0320] According to some exemplary embodiments, the body opening seals described herein are part of a system or part of a kit that includes a fluid extraction chamber.

[0321] Now refer to Figure 7 , which depicts a body opening seal according to some exemplary embodiments of the present invention.

[0322] According to some exemplary embodiments, a seal (e.g., an inflatable seal 702) is positioned in an opening formed in an abdominal wall 704. In some embodiments, the seal comprises at least one tube, such as a flexible tube 706 that passes through the inflatable seal 702. Optionally, the tube 706 is made of silicon. In some embodiments, the inflatable seal 702 is configured to expand (e.g., expand outward) within the opening in the abdominal wall and seal any gaps between the tissue of the abdominal wall surrounding the opening and the tube 706. In some embodiments, the inflatable seal comprises an airbag. In some embodiments, inflation of the airbag causes the seal to expand.

[0323] Exemplary fluid removal chamber with gradually opening apertures

[0324] According to some exemplary embodiments, a 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 flow into the interior volume of the filtration capsule at a pressure threshold that is different from the pressure threshold required to open the pores of a second membrane. In some embodiments, the gradually opening pores allows for sustained fluid removal over time, for example, when some pores of the filtration capsule become clogged.

[0325] According to some exemplary embodiments, a chamber with a pressure-dependent pore opening is used to treat patients with ascites (such as cirrhosis, cancer, nephrotic syndrome, or advanced heart failure) having varying degrees of fluid properties. In some embodiments, the chamber allows, for example, to facilitate chronic applications of ultrafiltration therapy, removing extracellular fluid from adjacent tissues over a long period of time and continuously, while also being characterized by other types of membrane behavior, thereby allowing rapid drainage of ascites fluid once acute accumulation occurs, without challenging the small-pore membrane by typically permeating thicker ascites fluid. In some embodiments, the chamber allows for treatment of a basal level of disease by removing ultrafiltrate while also responding to acute fluid accumulation in a given cavity.

[0326] Now refer to Figures 8A-8B , which depicts a wall of a chamber comprising two or more types of membrane portions according to some exemplary embodiments of the present invention.

[0327] According to some exemplary embodiments, chamber 802 includes wall 804. In some embodiments, wall 804 includes a first type of membrane 806 and a second type of membrane 808 positioned side by side in wall 804. In some embodiments, the wall defines an interior volume 810 of the chamber.

[0328] Figure 8C Depicted are graphs showing the pressure-dependent opening of pores in each type of membrane according to some exemplary embodiments of the present invention. Figure 8CIncluded is a graph showing the change in characteristic flow rate (supply rate in milliliters per minute divided by surface area) through the chamber relative to the pressure in the interior volume of the chamber when the pores of the first and second membranes are open.

[0329] According to some exemplary embodiments, for example Figure 8C As shown in , in the first stage of the filtration process, only the pores of the first type of membrane (e.g., type A membrane) are open, while the pores of type B membrane are closed. In some embodiments, as the pressure increases, the filtration rate or volume reaches a plateau, optionally due to pore clogging of the type A membrane. In some embodiments, as the pressure inside the internal volume of the chamber increases, reaching a certain value (e.g., P-critical 811), the pores of the type B membrane open, thereby increasing the characteristic filtration rate per unit surface area. In some embodiments, when the pressure is above P-critical 811, the pores of both membrane types are open.

[0330] Exemplary Multi-Lumen Port Tube

[0331] 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 facing the port and the interior volume of the fluid extraction chamber and at least one second lumen leading to the body cavity. In some embodiments, having the second lumen allows for the introduction of at least one tool (e.g., a catheter) into the abdominal cavity, for example, through a single tube passing through a single abdominal opening leading to the implanted fluid extraction chamber.

[0332] Now refer to Figures 9A-9C , which depicts an access tube leading to a port of a fluid extraction chamber comprising at least one additional external channel, according to some exemplary embodiments of the present invention.

[0333] According to some exemplary embodiments, the fluid extraction chamber 902 comprises a body, such as a filter capsule 904, coupled to an outlet 906. In some embodiments, the outlet 906 is connected to an outlet tube 908. In some embodiments, such as Figure 9C As shown in , outlet tube 908 extends from the patient's body through a single opening in the abdominal wall.

[0334] According to some exemplary embodiments, the outlet tube includes at least one additional lumen 912 that terminates beyond the outlet 906. In some embodiments, the at least one additional lumen allows the use of the same opening in the abdominal wall for both the outlet to the fluid extraction chamber and the introduction of at least one tool (e.g., a catheter) into the abdominal cavity 916.

[0335] According to some exemplary embodiments, the multi-lumen outlet tube is used to remove ascites during dialysis and / or ultrafiltration and for maintenance of body cavities or fluid extraction devices or for any other devices implanted in the abdominal cavity. In some embodiments, the multi-lumen tube is used to introduce a catheter (e.g., a drainage catheter), for example, to drain fluid that accumulates in a body cavity (e.g., the abdominal cavity), such as in clinical situations where fluid accumulates too quickly to allow for effective removal via chamber 902.

[0336] Exemplary Toxin Removal

[0337] According to some exemplary embodiments, during filtration and / or due to the patient's clinical state, the level of toxins in the body cavity fluid increases. 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, beads are used to remove protein-bound uremic toxins (PBUTs), such as kynurenine, kynurenic acid, indoxyl sulfate, and hippuric acid; other proinflammatory hormones, such as TNF-α, interleukin-6 (IL6); and fibrosis mediators, such as recombinant MMP-2 protein TIMP metallopeptidase inhibitor 1 (TIMP1) from body cavity fluid.

[0338] According to some exemplary embodiments, the beads are coupled to a wire that is introduced into the interior lumen of the chamber through the outlet. In some embodiments, to remove the beads, the wire is pulled out of the fluid extraction chamber. Alternatively, suction is applied to remove the beads.

[0339] According to some exemplary embodiments, for example Figure 10A As shown in , fluid extraction chamber 1002 includes outlet 1004, which has at least two separate flow paths entering the internal volume 1006 of chamber 1002. In certain embodiments, the outlet is connected to a multi-lumen tube. In certain embodiments, at least one flow path 1010 is used to insert a tube (e.g., a perforated tube 1008) into the internal volume 1006, for example to allow chamber 1002 to expand and / or for applying a vacuum. In certain embodiments, flow path 1010 terminates at a tube. In certain embodiments, at least one second flow path 1012 is used to deliver beads 1014 into the internal volume 1006. In certain embodiments, beads are attached to a line. Alternatively, beads are free to flow inside the internal volume 1006.

[0340] According to some exemplary embodiments, for example Figure 10BAs shown in FIG, chamber 1020 includes a single lumen outlet 1022 that is optionally coupled to a single lumen tube 1024. In some embodiments, chamber 1020 includes a valve 1026 (e.g., a leaflet valve) in outlet 1022 (e.g., between outlet 1022 and interior volume 1006). Alternatively, the valve is located within tube 1024 coupled to outlet 1022. In some embodiments, the valve is used to control the flow of beads 1028 through the single lumen of outlet 1022 and is also used for fluid removal. In some embodiments, valve 1026 includes a filter that allows fluid to be aspirated from interior volume 1006 without passing beads 1028 into outlet 1022. In some embodiments, to remove beads 1028, valve 1026 including a filter is actively opened, for example, by inserting a tube from outside the body through outlet 1022 into the interior volume, thereby causing the valve to open.

[0341] Exemplary Structures of Fluid Extraction Chambers

[0342] According to some exemplary embodiments, the fluid extraction chamber comprises an expandable body configured to enter a body cavity of a subject (e.g., into the abdominal cavity) in a collapsed state (e.g., folded state) and to expand (e.g., unfold) 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.

[0343] According to some exemplary embodiments, the inner support structure comprises a stent, which is optionally formed by one or more flexible stylets, optionally flexible stylets. In some embodiments, during insertion of the chamber into a body cavity of a subject, the one or more stylets are at least partially coupled to the body or a port of the body through which fluid is discharged from the lumen within the body. In some embodiments, during deployment of the body within the body cavity, the one or more flexible stylets are pushed into the lumen within the body from outside the chamber and, optionally, via the port, thereby stretching the body by pressing on the inner surface of the body.

[0344] Alternatively, when the chamber is introduced into the body cavity, the one or more stylets are already fully inserted into the inner lumen and are optionally folded in a collapsed state together with the chamber body. In some embodiments, during deployment in the body cavity, the one or more stylets self-expand and press the inner surface of the body. In some embodiments, the expansion of the one or more stylets comprises lateral expansion of the stylet. Alternatively or in addition, an elongated deployment tool (e.g., an expansion tool) coupled to the chamber body or inner support is used to expand the chamber body and / or support by applying force to the deployment tool from outside the subject's body. In some embodiments, for example, when using a deployment tool, the support (e.g., the one or more stylets) is optional.

[0345] Now refer to Figure 10C and 10D , which shows the structure of a fluid extraction chamber body according to some exemplary embodiments of the present invention.

[0346] According to some exemplary embodiments, fluid extraction chamber 1042 comprises a body 1042 having walls defining an inner lumen 1044. In some embodiments, body 1042 is an expandable body configured to move between a collapsed state (e.g., a folded state, optionally a rolled state) during insertion of chamber 1040 into a body cavity of a subject and an expanded state (e.g., a deployed state, optionally an unrolled state) when the fluid extraction chamber is deployed in the body cavity of the subject.

[0347] According to some exemplary embodiments, the chamber 1040 further comprises an internal support structure, such as a stent 1052, within the inner lumen 1044. In some embodiments, the body 1042 comprises an outlet 1046 (e.g., a port) through which the fluid in the inner lumen can exit the chamber via a drainage tube to a reservoir and / or outside the subject's body. In some embodiments, the stent 1052 is configured to expand the body 1042 by applying a force outward from the inner lumen 1044 on the inner surface of the wall 1048. In some embodiments, after the chamber 1040 is deployed within the body cavity and / or during active fluid extraction, the stent is mechanically coupled to the port 1046 and / or the body wall.

[0348] According to some exemplary embodiments, the wall of the body 1042 is formed by at least one outer membrane layer 1048 and at least one porous inner layer 1050 (e.g., a mesh layer or any other porous layer), wherein the at least one outer membrane layer has pores that allow fluid to penetrate from the body cavity into the inner tubular cavity 1044 of the chamber 1040.

[0349] According to some exemplary embodiments, for example Figure 10DAs shown in FIG, the at least one inner layer 1050 is used to adhere two portions of the at least one outer film layer 1048 together, for example, within the periphery of the body 1042. In some embodiments, the two portions of the at least one outer film layer 1048, or at least two separate outer film layers, are welded, for example, along a double weld seam, to the at least one inner layer 1050 positioned therebetween. In some embodiments, the seam between the two film layers or between the two portions of a single layer is formed and positioned 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 film layer 1048 is formed from at least one of polyethersulfone (PES), polyvinylidene fluoride (PVDF), polytetrafluoroethylene (PTFE), nylon, cellulose, collagen, or any derivative thereof, or any other similar material.

[0350] According to some exemplary embodiments, at least one guide wire is inserted into the inner lumen 1044 as or in addition to the stent 1052 , for example to mechanically support the body against external forces and / or to maintain the body in an expanded state.

[0351] Exemplary fluid extraction chamber with introducible scaffold

[0352] According to some exemplary embodiments, the fluid extraction chamber comprises an inner stent, optionally an expandable stent or a non-collapsible stent. In some embodiments, the inner stent is preformed to assume a specific form when expanded within the body of the fluid extraction chamber. Optionally, the inner stent is formed from a shape memory alloy, such as nickel titanium alloy (Nitinol), a copper-based alloy, an iron-manganese-silicon alloy, an iron-platinum alloy, and / or a gold-cadmium alloy.

[0353] A potential advantage of having a pre-shaped inner stent may be that it allows control of the forces exerted on the inner surface of the fluid extraction chamber body after inflation and / or the shape of the fluid extraction chamber body after deployment and / or the strength of the body to resist external forces exerted on the fluid extraction chamber by organs within the body cavity, optionally during movement of the subject.

[0354] Now refer to Figures 11A-11D , which depicts a fluid extraction chamber with an introducible support structure (eg, a stent) therein, according to some exemplary embodiments of the present invention.

[0355] According to some exemplary embodiments, the fluid extraction chamber 1102 comprises a body 1104 having an inner lumen 1106. In some embodiments, the body 1104 is configured to be in a collapsed state when inserted into a body lumen and to expand within the body lumen using an internal stent (e.g., a support structure). In some embodiments, the wall of the body comprises a porous membrane having pores sized to allow, for example, fluid to enter the inner lumen 1106 from the body lumen, optionally as Figure 1 and 2A In some embodiments, body 1104 includes at least one opening, such as outlet opening 1108, configured to allow fluid to be discharged from inner lumen 1106 via a drainage tube outside the subject's body, or alternatively, to allow fluid to be discharged from inner lumen 1106 via a drainage tube into an organ in the subject's body. It should be understood that in some embodiments, the term outlet opening of the fluid extraction chamber refers to a port or connector in the opening of the chamber body through which fluid and / or other elements can enter and exit the chamber lumen.

[0356] According to some exemplary embodiments, body 1104 is introduced into a body cavity of a subject in a collapsed state, e.g., as Figure 11A , and the inner stent 1110 is partially introduced into the inner lumen 1106, optionally through the at least one outlet 1108 or through a tube or channel in the outlet 1106. In some embodiments, when the body 1106 of the chamber is within the body cavity of a subject, the stent 1110 is advanced into the body cavity 1106 to expand the body 1104 to an expanded state, for example, as Figure 11B In some embodiments, the distal end 1109 of the stylet 1110 is coupled to the port 1108 , while the proximal end of the stent is configured to move into the inner lumen 1106 , for example, to expand the body 1104 .

[0357] According to some exemplary embodiments, stent 1110 includes at least one elongated stylet, optionally formed from a shape memory alloy. In some embodiments, when the stylet is advanced into inner lumen 1106, the stylet pushes outwardly against the inner surface of body 1104, thereby expanding body 1104. In some embodiments, the stylet is preformed, e.g., pretreated, to achieve a specific target shape when advanced into inner lumen 1106. In some embodiments, the stylet is formed from at least one, or two or more, wires of nitinol, metal, and / or polymeric material.

[0358] According to some exemplary embodiments, for example Figure 11C, which is an enlarged view of the outlet area, the outlet 1108 optionally includes a recess 1112 located in the inner surface of the outlet 1108, or alternatively, located in the inner surface of a connector 1114 positioned within the outlet 1108. Optionally, the connector 1114 is shaped and sized to allow the 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.

[0359] According to some exemplary embodiments, the recess 1112 is shaped and sized to match the proximal portion 1114 of the stylet to prevent the stylet 1110 from advancing forward into the inner lumen 1106. In some embodiments, the proximal portion 1114 is shaped as an angled extension that extends toward the distal end of the stylet toward the inner lumen 1106. In some embodiments, the recess is shaped as an elongated recess that optionally extends at an angle toward the inner lumen 1106. In some embodiments, when the proximal portion of the stylet 1110 passes within the outlet 1108, the elongated proximal portion 1114 is pushed into the elongated recess. In some embodiments, the interaction between the elongated extended proximal portion 1114 of the stylet 1110 and the recess 1112 mechanically interferes with the advancement of the stylet into the inner lumen 1106.

[0360] According to some exemplary embodiments, movement of the stent 1110 (e.g., rotation of the stent) releases the proximal portion from the exit opening (e.g., from the connector) to optionally allow the stent 1110 to be retracted from the inner lumen 1106, for example to allow removal of the chamber 1102 from the body cavity of the subject.

[0361] Exemplary fluid extraction chamber with integrated support

[0362] Now refer to Figure 12A and 12B , which depicts a fluid extraction chamber with an integrated support according to some exemplary embodiments of the present invention.

[0363] 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 comprises at least one internal support 1210 integral with the body 1204. In some embodiments, during introduction of the chamber 1202 into a body cavity of a subject, when the chamber 1202 is in a position such as Figure 12A and when chamber 1202 is expanded within the body cavity to obtain, for example, Figure 12B In the expanded state shown in FIG, the stent 1210 is coupled to the body 1204. In some embodiments, Figure 15AIn the collapsed state shown in FIG, the chamber 1202 including the outer membrane is folded and is configured to unfold into an expanded state, as shown in FIG. Figure 12B In some embodiments, the bracket 1210 is at least partially mechanically connected to the inner surface of the body 1204. Alternatively or additionally, the bracket is mechanically coupled to the port opening 1208, such as a connector that locates or forms the port opening 1208.

[0364] According to some exemplary embodiments, for example as described with respect to stent 1110, stent 1210 is optionally formed of a shape memory alloy and comprises at least one elongated stylet. Optionally, stent 1210 is thin, having a thickness value between 0.2 mm and 1.7 mm, for example, between 0.2 mm and 0.7 mm, between 0.5 mm and 1.2 mm, between 0.8 mm and 1.7 mm, or any intermediate, smaller or larger thickness value. Optionally, the cross-section of the stylet is annular, circular, oval, elliptical, polygonal, or shaped as a rectangle. In some embodiments, the stylet is formed of at least one, or two or more wires of nitinol, metal, and / or polymer material.

[0365] According to some exemplary embodiments, the support 1210 is flexible and optionally elastic. In some embodiments, the support 1210 is configured to be flexible when the chamber is in a compressed state (e.g., Figure 12A Optionally, the stent 1210 is configured to collapse when the chamber is in the collapsed state, optionally during the introduction of the chamber 1202 into a body cavity (e.g., as shown in FIG. Figure 12A In some embodiments, the stent is unfolded to obtain a circular shape, pushing the inner surface of the body 1204 and expanding the body 1204 and the chamber 1202, for example, as shown in FIG. Figure 12B Optionally, stent 1210 is configured to be collapsed within a body cavity, optionally to allow for removal of chamber 1202 from the body cavity of a subject.

[0366] Now refer to Figure 13A and 13B , which depicts an inner stent formed of 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.

[0367] According to some exemplary embodiments, the fluid extraction chamber 1302 comprises a body 1304 having an inner lumen 1306 and an outlet opening 1308 leading to the inner lumen 1306. Optionally, for example, Figure 13A, the body 1304 includes an inner balloon within an inner lumen 1306. In some embodiments, the chamber 1302 includes at least one inner stent formed by at least one outer stylet 1310 and at least one inner stylet 1312. In some embodiments, each stylet has a different level of elasticity, for example, to resist different external forces applied to the body 1304. In some embodiments, the at least one inner stent including the outer stylet 1310 and the inner stylet 1312 is positioned within the inner lumen 1306 of the body 1304 and optionally within the balloon.

[0368] Optionally, the at least one inner support comprising the outer stylet 1310 and the inner stylet 1312 is integrated with the body 1304, for example, mechanically coupled to the inner surface of the sac, the body 1304, or the outlet 1308, for example, coupled to a port. Alternatively or additionally, the at least one inner support comprising the outer stylet 1310 and the inner stylet 1312 is mechanically coupled to the outlet 1308, optionally to at least one connector positioned within the outlet. Optionally or additionally, the outer stylet 1310 and the inner stylet 1312 are mechanically coupled to each other, for example to allow simultaneous deployment. In some embodiments, in the expanded state, the diameter of the at least one inner support 1312 is smaller than the diameter of the at least one outer support 1310. In some embodiments, the outer stylet 1310 and the inner stylet 1312 are arranged and / or function in a series configuration, for example to resist external forces applied to the body 1304. In some embodiments, the inner stylet and / or outer stylet are formed from at least one, or two or more wires of nitinol, metal, and / or polymer material.

[0369] According to some exemplary embodiments, for example Figure 13B , having an inner stent formed of at least one outer stylet 1310 and at least one inner stylet 1312 optionally allows the body 1304 to gradually collapse by pressure applied to the body 1304 by an organ 1320 or tissue within a body cavity. In some embodiments, the organ 1320 pushes the adventitia of the body 304 inwardly, while simultaneously bending the outer stylet 1310 inwardly into the inner stylet 1312. In some embodiments, the inner stylet 1312 is less flexible and / or more resistant to bending than the outer stylet 1310 and resists the pressure applied by the organ 1320. In some embodiments, the inner stylet 1312 allows for the maintenance of a functional volume of the inner lumen 1306 that is sufficient to expand and compress the body when pressure is applied by a pump of the inner volume 1306 for removing fluid from the body cavity.

[0370] Optionally, the outer stylet 1310 and the inner stylet 1312 are similar to Figure 12A and 12B The stylet 1210 described in .

[0371] Exemplary Expansion of the Fluid Extraction Chamber

[0372] According to some exemplary embodiments, the fluid extraction chamber includes at least one support structure, such as an internal stent, positioned within the inner lumen of the fluid extraction chamber body. In some embodiments, the at least one internal stent is an expandable stent configured to move between a collapsed state and an expanded state within a body cavity of a subject. Optionally, the at least one stent is a reversibly expandable stent configured to move between an expanded state and a collapsed state within the body cavity of a subject, for example to allow removal of the fluid extraction chamber from the body cavity of the subject. In some embodiments, expansion of the stent causes the fluid extraction chamber to expand.

[0373] According to some exemplary embodiments, the stent is a self-expanding stent. Alternatively, the stent expands in response to a force applied to the stent 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 stent. Alternatively or additionally, the applied force changes the configuration and / or shape of the fluid extraction chamber body. In some embodiments, applying the force from outside the subject's body allows, for example, to control the expansion time 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 an organ in the subject's body cavity to clear a volume in the body cavity sufficient to expand the fluid extraction chamber.

[0374] Now refer to Figures 14A-14C , which depicts the expansion of a fluid extraction chamber using at least one external rod according to some exemplary embodiments of the present invention.

[0375] According to some exemplary embodiments, the fluid extraction chamber 1402 comprises a body 1404 having an inner lumen 1406 and at least one outlet opening 1408 for fluidically connecting the inner lumen 1406 to at least one tube 1407. In some embodiments, the chamber 1402 comprises at least one inner stent 1410 configured to, optionally, collapse in a collapsed state (folded into, for example, two rings, such as two rings) upon insertion of the chamber into a body cavity of a subject. Figure 14A ) and an expanded state (eg, when chamber 1402 is deployed within a body lumen of a subject, inner stent 1410 expands laterally to form a single ring).

[0376] Optionally, for example Figure 14AAs shown in , when the fluid extraction chamber 1402 is introduced into the subject's body cavity, the body 1404 is placed within the outer sheath. In some embodiments, the sheath is a dissolvable sheath configured to dissolve when exposed to the fluid in the subject's body cavity. Alternatively, the sheath is a removable sheath configured to be retracted from the subject's body cavity after the chamber 1402 is inserted into the subject's body cavity. In some embodiments, the sheath, optionally formed of at least one piece of material, is configured to reduce friction between the outer surface of the chamber body 1404 and the tissue of the subject's body during the insertion of the chamber 1402 into the subject's body cavity. Optionally, the sheath is configured to be retracted from the subject's body. Optionally, the sheath is a tearable sheath.

[0377] According to some exemplary embodiments, after chamber 1402 is positioned within a body cavity of a subject, at least one elongated deployment tool (e.g., rod 1414) is introduced into inner lumen 1406 of body 1404 through exit opening 1408 and into contact with stent 1410. In some embodiments, the proximal end of rod 1414 is located outside the subject's body, e.g., to allow manipulation of the rod and distal end of the rod from outside the subject's body. Optionally, rod 1414 is introduced into lumen 1406 after removing the outer sheath. In some embodiments, e.g., as Figure 14B As shown in FIG, rod 1414 (eg, distal end 1416) exerts a force on stent 1410, optionally pushing stent 1410, sufficient to move the stent from a collapsed state to an expanded state, thereby expanding body 1404.

[0378] Alternatively, chamber 1402 is introduced into a body cavity of a subject when rod 1414 (e.g., distal end 1416 of rod 1414) is mechanically coupled to stent 1410 and the proximal end of rod 1414 is located outside the subject's body. In some embodiments, after stent 1410 is expanded, rod 1414 is retracted from expansion body 1404 via outlet 1408.

[0379] According to some exemplary embodiments, rod 1414 is rigid in an axial direction along the long axis of rod 1414 and optionally flexible in a transverse direction at an angle to the long axis, for example to allow rod 1414 to be advanced and / or retracted within a tube connected to outlet 1408 while optionally allowing rod 1414 to bend within the tube.

[0380] Now refer to Figures 14D-14G , which depicts the deployment rod being decoupled from the stent according to some exemplary embodiments of the present invention.

[0381] According to some exemplary embodiments, for example Figure 14D and 14E, rod 1420 is a hollow rod having at least one wire 1422 passing within a lumen 1424 of rod 1420 between a proximal end of the rod located outside the subject's body and a distal end 1426 of rod 1420 that is mechanically coupled to stent 1410. In some embodiments, pulling the at least one wire 1422 decouples distal end 1426 from stent 1410, optionally tearing distal end 1426 from stent 1410, e.g., as Figure 14E As shown in .

[0382] Alternatively, for example Figure 14F and 14G , rod 1430 includes a gripping portion 1432, such as a distal gripping portion configured to grasp and release stent 1410 in response to a proximal end of the rod 1430 (e.g., the proximal portion of the rod) positioned outside of the body cavity of the subject. Optionally, rod 1430 is a grasper tool or a rod of a grasper tool.

[0383] According to some exemplary embodiments, the fluid extraction chamber is expanded using at least one external expansion tool (e.g., an expander) that is controlled from outside the body lumen and is used to apply a force to the chamber body sufficient to at least partially expand the chamber. In some embodiments, the expander expands the chamber body to a degree that allows expansion of the stent, for example, to stabilize the chamber body in an expanded state within the body lumen.

[0384] Now refer to Figures 15A-15C , which depicts the expansion of a fluid extraction chamber using an expansion tool (eg, an expander) according to some exemplary embodiments of the present invention.

[0385] According to some exemplary embodiments, fluid extraction chamber 1502 comprises a body 1504, e.g., an expandable body 1504, having an inner lumen 1506 and at least two outlet openings 1508 and 1512 leading to inner lumen 1506. In some embodiments, chamber 1502 comprises at least one inner stent 1510 positioned within inner lumen 1506. In some embodiments, the at least one inner stent 1510 is mechanically coupled to an expansion tool, e.g., an expander comprising at least two elongated rods 1508 and 1512, each of which penetrates into inner lumen 1506 via a different outlet opening in openings 1508 and 1512, e.g., Figure 15A Optionally, chamber 1502 is placed within sheath 1503 when introduced into a body cavity of a subject.

[0386] According to some exemplary embodiments, when the chamber 1502 is introduced into a body cavity, organs and / or tissues within the body cavity exert forces on the outer surface of the body 1504, thereby preventing the stent and / or the body 1504 from expanding. In some embodiments, for example, Figure 15B , to allow stent 1510 and / or body 1504 to expand, each of the at least two rods 1514 and 1516 pushes against the inner surface of body 1504 or stent 1510 in opposite directions, thereby expanding body 1504. In some embodiments, the distal ends of each of the rods are optionally moved in opposite directions relative to each other, for example, to expand body 1504. In some embodiments, the force exerted by each of rods 1514 and 1516 on the wall of body 1504 pushes tissue and / or organs against body 1504 from the outside to a degree that allows expansion of inner stent 1510, so as to stabilize body 1504 in the expanded state.

[0387] According to some exemplary embodiments, body 1504 in the expanded state has a trapezoidal shape.

[0388] According to some exemplary embodiments, for example Figure 15C As shown in FIG, after the body 1504 and / or the inner support 1510 are expanded, the expander comprising the at least two rods is retracted and the outlets 1508 and 1512 are connected to at least one pump 1520 via conduits 1522 and 1524. Optionally, the tubes 1522 and 1524 are coupled to the pump via a connector (e.g., a Y-connector 1526).

[0389] Now refer to Figures 16A-16C , which depicts the expansion of a fluid extraction chamber using an expansion tool comprising at least two external rods according to some exemplary embodiments of the present invention.

[0390] According to some exemplary embodiments, for example Figure 16A and 16BAs shown in , chamber 1602 includes a body 1604 having an inner lumen 1606 and at least one outlet opening 1608. In some embodiments, chamber 1602 includes at least one inner support 1610, optionally a stylet. In some embodiments, the outer surface of body 1604 is mechanically coupled to an expander, such as at least two rods (e.g., rods 1614 and 1616) coupled to the expander. In some embodiments, each of rods 1614 and 1616 is coupled to the outer surface of body 1604 by at least one fastener (e.g., rings 1618 and 1620). According to some exemplary embodiments, during insertion of chamber 1602 into a body cavity of a subject, rods 1614 and 1616 are optionally substantially parallel to each other. In some embodiments, after chamber 1602 is positioned within the body cavity of the subject, the proximal portion of each of the rods (e.g., portions 1629 and 1629) that is optionally located outside the subject's body moves toward the proximal portion of a different rod, such as Figure 16B Optionally, the distal ends 1630 and 1632 of the rods are moved further away from each other as shown in FIG. Optionally, the proximal portions 1627 and 1629 are moved until they cross over each other, as for example Figure 16B In some embodiments, Figure 15A and 15B The movement of the proximal portions of rods 1514 and 1516 shown in FIG. 1 is similar to the movement of proximal portions 1627 and 1629 .

[0391] According to some exemplary embodiments, when the distal ends of rods 1614 and 1616 move away from each other, body 1604 expands, thereby allowing stent 1610 to expand and stabilizing body 1604 in the expanded state. In some embodiments, after chamber body 1604 and stent 1610 are expanded, rods 1614 and 1616 are retracted and, optionally, pulsed out of the body cavity using wires 1613 and 1615, each extending from the proximal end of a different rod.

[0392] In some embodiments, the rod as described herein is a straight rod or an angled rod. In some embodiments, the rod as described herein is flexible or rigid.

[0393] Now refer to Figures 17A-17C , which depicts the expansion of a fluid extraction chamber using an external expansion tray according to some exemplary embodiments of the present invention.

[0394] According to some exemplary embodiments, a fluid extraction chamber 1702, indicated by dashed lines in the figures, includes a body 1704 (e.g., an expandable body) having an inner lumen 1706 and at least one inner stent 1710 within the inner lumen 1706. Additionally, the body 1704 includes at least one outlet opening 1708 leading to the inner lumen 1706, the at least one outlet opening being configured to allow fluid to be extracted from the inner lumen 1706 out of the chamber 1702, optionally via at least one tube coupled to the outlet opening 1708.

[0395] According to some exemplary embodiments, during insertion of chamber 1702 into a body cavity within a subject's body, chamber 1702 is coupled to external expansion tray 1730. Figures 17A-17C Represented by continuous lines and circles.

[0396] 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 and / or overlap, optionally completely overlap, the long axis of the plate 1732, and a second state in which the arms 1734 and 1736 extend laterally relative to the plate 1732.

[0397] According to some exemplary embodiments, expansion tray 1702 includes at least one elongated actuation rod 1742 functionally coupled to arms 1734 and 1736 and / or hinges 1738 and 1740. In some embodiments, movement (eg, axial movement) of rod 1742 moves the arms between a first state and a second state.

[0398] According to some exemplary embodiments, chamber 1702 is coupled, optionally reversibly coupled, to arms 1734 and 1736. Optionally, arms 1734 and 1736 are coupled to opposing edges of body 1704.

[0399] According to some exemplary embodiments, for example Figure 17A , during insertion of chamber 1702 into a subject's body, chamber 1702 is coupled to and held in a collapsed state by tray 1730. In some embodiments, in a first state, arms 1734 and 1736 are substantially aligned with plate 1732, thereby holding chamber 1702 in a collapsed state.

[0400] According to some exemplary embodiments, for example Figure 17BAs shown in , to expand chamber 1702, actuator rod 1742 is moved and / or rotated, for example, axially. Optionally, for example, as Figure 17B , rod 1742 is retracted to expand chamber 1702. In some embodiments, movement of rod 1742, such as retraction of the rod, moves arms 1734 and 1736 to a second state, in which arms 1734 and 1736 extend laterally away from plate 1732. In some embodiments, extension of arm 1724, which is mechanically coupled to body 1704, expands body 1704. In some embodiments, expansion of body 1704 allows inner stent 1710 to expand and stabilizes body 1704 and chamber 1702 in a functionally expanded state, optionally ready for functional extraction of fluid from a body cavity upon application of negative pressure by a pump on inner lumen 1706 via an outlet. In some embodiments, the expansion tray is removed from the subject's body when arms 1734 and 1736 return to the first state, in which the arms are substantially aligned with plate 1732.

[0401] Optionally, for example Figure 17C As shown in , further manipulation (eg, axial and / or rotational movement of rod 1742 ) decouples expansion tray 1730 from chamber 1702 , thereby allowing, for example, expansion tray 1730 to be retracted from the subject's body.

[0402] Now refer to Figure 17D and 17E , which depicts the movement of an arm of an expansion tray according to some exemplary embodiments of the present invention.

[0403] According to some exemplary embodiments, each of the arms of the expansion tray (e.g., arm 1750) is functionally 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 tethered to the loop by a knot that can be untied, e.g., when the wire is pulled, optionally decoupling the arm 1750 from the loop 1754 and the chamber body 1752.

[0404] According to some exemplary embodiments, arm 1750 includes a cog 1760 at the proximal end of arm 1750. In some embodiments, the teeth of cog 1760 mate with recesses 1762 between the teeth at the distal end of an elongated actuator rod, to which the cog is functionally coupled, such that axial movement of rod 1764 is converted into rotational movement of cog 1760 and movement of arm 1750. In some embodiments, for example, Figure 17E As shown in , retraction of rod 1764 causes arms 1750 to extend laterally, thereby expanding body 1754.

[0405] Exemplary Chamber Deployment

[0406] According to some exemplary embodiments, the fluid extraction device is inserted into a body cavity, such as 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.

[0407] According to some exemplary embodiments, the fluid extraction chamber is introduced into a body lumen in a collapsed state (e.g., in a folded state), optionally with the stent at least partially coupled to the chamber body. In some embodiments, when the chamber is introduced into the body lumen, one or more organs or tissues in the body lumen need to be moved to allow space for proper expansion of the chamber.

[0408] In some embodiments, an expansion tool is used to help expand the chamber within the body cavity, such as to unfold the chamber. In some embodiments, the expansion tool is coupled to the chamber and / or the inner support and extends out of the body cavity. In some embodiments, the tool is manipulated from outside the body cavity (e.g., from outside the subject's body) to apply a force sufficient to expand the chamber within the body cavity on the chamber body and / or the inner support. In some cases, a combination of manipulation from outside the body and from inside the body is utilized, for example, by inserting one or more additional expansion guidewires into the inner lumen of the chamber body.

[0409] Now refer to Figure 18 , which depicts a process of deploying a fluid extraction chamber within a body cavity using an inflation tool according to some exemplary embodiments of the present invention.

[0410] According to some exemplary embodiments, at block 1802, an opening to a body cavity is formed. In some embodiments, the opening is formed, for example, Figure 1 As described at block 106 in the embodiment of the present invention. In some embodiments, the opening is formed under local anesthesia.

[0411] According to some exemplary embodiments, at frame 1804, the fluid extraction chamber is introduced into the body cavity via the formed opening. In some embodiments, the chamber (optionally an elongated chamber) is introduced into the body cavity in a collapsed state (e.g., a collapsed state in which the chamber body is folded or rolled up) within an outer sleeve (e.g., a sheath), which wraps around the chamber and optionally holds the chamber in the collapsed state. In some embodiments, the chamber includes an expandable inner support that is at least partially coupled to the chamber body or 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, such as an expander. In some embodiments, the expander is an elongated expander having a distal end coupled to the chamber and a proximal end located outside the body cavity, optionally outside the subject's body.

[0412] 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 via the formed opening. In some embodiments, the outer sleeve is removed, for example, by pulling a wire coupled to the outer sleeve from outside the subject's body.

[0413] According to some exemplary embodiments, optionally, at block 1808, the proximal end of the stent is moved into the chamber. In some embodiments, the stent is moved into the chamber to expand the chamber body within the body lumen. In some embodiments, the stent is moved into the chamber, e.g., Figures 11A-11D As described in.

[0414] Alternatively and optionally, for example, when the entire stent is already within the lumen during insertion of the lumen into the body lumen, the stent self-expands (optionally laterally) or deploys at block 1804. In some embodiments, the stent self-expands or deploys after the outer sleeve is removed at block 1806.

[0415] According to some exemplary embodiments, at block 1810, the expansion tool is moved. In some embodiments, the expansion tool comprises at least one rod (e.g., Figures 14A-14G ) or at least two rods (e.g. as shown in FIG) or at least two rods (e.g. as shown in FIG) Figures 15A-15C and Figures 16A-16C shown in ) or Figures 17A-17E The expansion tool of the expansion tray shown in FIG is moved from outside the body cavity (eg, from outside the subject's body).

[0416] According to some exemplary embodiments, the movement of the expansion tool comprises axial movement and / or rotation. In some embodiments, the movement of the expansion tool causes the chamber body to expand, for example, to deploy the chamber body. Optionally, the expansion of the chamber body allows the stent to expand and maintain the chamber in an expanded state.

[0417] In some embodiments, when an expansion tool (e.g., expander) is used, the stent is optional and the device does not include a stent. In these embodiments, after expansion, the chamber is sufficiently rigid to maintain the expanded state and / or resist external forces without the stent.

[0418] According to some exemplary embodiments, at block 1812, the expansion tool is removed from the body cavity. In some embodiments, the expansion tool is decoupled from the cavity and removed by pulling one or more wires from outside the body cavity. In some embodiments, the expansion tool is decoupled from the cavity by applying a force on a tear region between the tool and the cavity and / or by releasing at least one gripping head of the tool from the cavity, e.g., Figures 14D-14G As shown in .

[0419] According to some exemplary embodiments, the chamber is coupled to a tube and / or pump at block 1814. In some embodiments, the chamber is coupled to the tube and / or pump after the chamber is expanded 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, such as a drainage tube.

[0420] As used herein with reference to an amount or value, the term "about" means "within ±10% of."

[0421] The terms "comprises," "comprising," "includes," "including," "has," "having" and conjugations thereof mean "including but not limited to."

[0422] The term "consisting of" means "including and limited to."

[0423] The term "consisting essentially of" means that the composition, method or structure may include additional ingredients, steps and / or parts, but only if the additional ingredients, steps and / or parts do not materially change the basic and novel characteristics of the claimed composition, method or structure.

[0424] As used herein, the singular forms "a / an" and "the" include plural referents unless the context clearly indicates otherwise. For example, the term "a compound" or "at least one compound" may include a plurality of compounds, including mixtures thereof.

[0425] Throughout this application, embodiments of the present invention may be presented with reference to a range format. It should be understood that descriptions in range format are merely for convenience and brevity and should not be construed as rigid limitations on the scope of the invention. Therefore, descriptions of ranges should be considered to have specifically disclosed all possible subranges and individual numerical values ​​within the range. For example, descriptions of ranges 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," etc.; and individual numbers within the range, e.g., 1, 2, 3, 4, 5, and 6. This applies regardless of the breadth of the range.

[0426] Whenever a numerical range is indicated herein (e.g., "10-15," "10 to 15," or any pair of numbers connected by such another range indicator), it is meant to include any number (fractional or integer) within the indicated range limits (including the range limits) unless the context clearly indicates otherwise. The phrases "range / ranging / ranges" between a first and a second indicated number and "range / ranges" from a first indicated number "to / up to / until / through" (or another such range indicating term) to a second indicated number are used interchangeably herein and are intended to include the first and second indicated numbers and all fractions and integers therebetween.

[0427] Unless otherwise indicated, the numbers used herein and any numerical ranges based upon such numbers are approximations within a reasonable degree of accuracy of measurement and rounding error, as understood by one skilled in the art.

[0428] As used herein, the term "treating" includes abrogating, substantially inhibiting, slowing or reversing the progression of a condition, substantially ameliorating clinical or aesthetic symptoms of a condition, or substantially preventing the appearance of clinical or aesthetic symptoms of a condition.

[0429] It should be understood that certain features of the invention described in the context of separate embodiments for clarity may also be provided in combination in a single embodiment. Conversely, various features of the invention described in the context of a single embodiment for simplicity may also be provided in any other described embodiment of the invention, alone or in any suitable subcombination or where appropriate. Certain features described in the context of individual embodiments should not be considered essential features of those embodiments, unless the embodiment would be ineffective without those elements.

[0430] Although the present invention has been described in conjunction with specific embodiments thereof, it is apparent that many alternatives, modifications and variations are apparent to those skilled in the art. It is therefore intended to encompass all such alternatives, modifications and variations that fall within the spirit and broad scope of the appended claims.

[0431] The applicant's intention is that all publications, patents and patent applications mentioned in this specification are incorporated herein by reference in their entirety, just as if each individual publication, patent or patent application were specifically and individually indicated as being incorporated herein by reference when cited. In addition, the citation or identification of any reference in this application should not be interpreted as an admission that this reference is available as prior art for the present invention. In the sense of using section headings, they should not be interpreted as necessarily limiting. In addition, any priority document of the present application is hereby incorporated herein by reference in its entirety.

Claims

1. A fluid extraction chamber adapted for implantation into a non-insufflated abdominal cavity, the fluid extraction chamber comprising: an elongated inflatable body having a major axis and a minor axis and configured to move from a collapsed state to an expanded state when deployed in the non-insufflated abdominal cavity, wherein the elongated inflatable body comprises a fluid-permeable wall defining an interior volume of the elongated inflatable body; wherein in the collapsed state, the elongate expandable body is shaped and sized to pass through an opening in the abdominal wall into a non-insufflated abdominal cavity, and wherein in the expanded state, the elongate expandable body is thin and has a surface area that is at least 5 times the surface area of ​​the elongate expandable body in the collapsed state; An outlet is coupled to the elongated expandable body, the outlet having at least one opening to the interior volume.

2. The chamber of claim 1, wherein the chamber is adapted to be implanted into the non-insufflated abdominal cavity under local anesthesia.

3. The chamber according to any one of claims 1 or 2, wherein the maximum width of the elongated expandable body in the expanded state is at least 3 times the maximum width of the elongated expandable body in the collapsed state.

4. The chamber of any of the preceding claims, comprising an elastic porous skeleton positioned within the interior volume, the elastic porous skeleton in contact with the inner surface of the fluid permeable wall, wherein the elastic porous skeleton is configured to apply a force to the inner surface to collapse when the elongated body is in a collapsed state and to expand when the elongated expandable body is in an expanded state when deployed in the non-insufflated abdominal cavity. The chamber of claim 4 , wherein the elastic porous framework comprises at least one layer of an elastic semi-rigid mesh.

6. The chamber according to any one of claims 4 or 5, wherein the elastic porous skeleton is shaped as a sponge.

7. The chamber of any one of claims 4 to 6, wherein the pores in the elastic porous framework are of similar size and / or shape.

8. The chamber of any one of claims 4 to 6, wherein the pores in the elastic porous framework have varying sizes and / or shapes.

9. The chamber of any one of claims 4 to 8, wherein the elastic porous framework comprises an auxetic structure and / or an auxetic material configured to allow the elastic porous framework to expand when the elastic porous framework is stretched.

10. A chamber according to any one of claims 4 to 9, wherein the elastic porous framework comprises integrated flow paths that converge in the outlet, and wherein the shape and size of the integrated flow paths are set to direct fluid entering the interior volume through different parts of the body toward the outlet.

11. The chamber of any preceding claim, 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 of the width to the length of the body in the expanded state is at least 1:1.

4.

13. A chamber according to any of the preceding claims, wherein the ratio of the length to the width of the elongated expandable body in the collapsed state is at least 3:

1.

14. The chamber of any preceding claim, wherein the maximum width of the elongate expandable body in the collapsed state is less than 10 mm.

15. The chamber of any preceding claim, wherein in the expanded state the body comprises a flexible stylet configured to push the fluid permeable wall outwardly.

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

17. A chamber according to claim 15, wherein the body includes a circumferential channel, the circumferential channel being configured to receive the flexible guide needle, and wherein the flexible guide needle is configured to be inserted into the circumferential channel through the outlet when the slender expandable body is located in the abdominal cavity.

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

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

20. The chamber of any of the preceding claims, comprising a sheath positioned around the elongated expandable body when the elongated expandable body is in the collapsed state, wherein the sheath is configured to increase the stiffness of the elongated expandable body in the direction of the longitudinal axis.

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

22. The chamber of any one of claims 20 or 21, wherein the sheath is formed of a dissolvable material configured to dissolve upon interaction with fluid in the abdominal cavity.

23. The chamber of any one of the preceding claims, 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 to prevent fluid from passing through the fluid-permeable wall.

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 interior volume.

26. The chamber of any preceding claim, wherein the wall comprises at least one membrane layer having pores with a size ranging between 0.1 μm and 100 μm.

27. A chamber according to any of the preceding claims, wherein the fluid permeable wall is at least partially formed by at least two types of membranes, wherein the pores of at least one of the at least two membrane types are configured to open at a pressure level different from the pressure level required to open the pores of at least one second membrane of the at least two membrane types to allow fluid to pass through.

28. A chamber according to any of the preceding claims, wherein the outlet comprises at least one flow path and a filter valve located in the flow path, wherein the filter valve is configured to allow fluid to pass when the valve is closed and to open when a tool is inserted through the outlet toward the interior volume.

29. A chamber according to any of the preceding claims, wherein the outlet comprises at least two separate flow paths into the interior volume, wherein at least one flow path is used to extract fluid from the interior volume and wherein at least one second flow path is used to introduce toxin-bound beads into the interior volume.

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

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

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. 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; At least one tube is passed through 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 when the expandable body is configured to seal a gap between the abdominal wall and the at least one tube when expanded.

34. A fluid extraction chamber adapted for implantation into the peritoneal cavity, the fluid extraction chamber comprising: An expandable body configured to move from a collapsed state to an expanded state, wherein the expandable body comprises a fluid-permeable wall comprising at least one layer of a porous membrane, wherein the fluid-permeable wall defines an interior volume of the body, wherein an inner layer of the fluid-permeable wall is coated with a degradable coating; wherein in the collapsed state, the expandable body is shaped and sized to pass through an opening in the abdominal wall into the abdominal cavity and to expand within the abdominal cavity by injecting fluid into the interior volume, and wherein the degradable coating is configured to temporarily seal the pores of the membrane to prevent the injected fluid from flowing out of the interior volume through the fluid-permeable wall.

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

36. A fluid extraction chamber adapted for implantation into a body cavity, the fluid extraction chamber comprising: an elongated expandable body configured to move from a collapsed state to an expanded state when deployed in the body lumen, wherein the elongated expandable body comprises a fluid permeable wall defining an interior volume of the elongated expandable body; an outlet coupled to the elongated expandable body, the outlet having at least one opening to the interior volume; At least one flexible, elongated stylet is positioned within the interior volume and is at least partially coupled to the outlet or the body when the elongated expandable body is introduced into the body cavity, wherein the at least one flexible, elongated stylet is configured to push the fluid-permeable wall outward from within the interior volume during the deployment of the elongated expandable body so as to expand the elongated expandable body within the body cavity.

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

38. A chamber according to any one of claims 36 or 37, wherein the at least one slender flexible tube needle includes a distal end and a proximal end, the distal end is mechanically connected to the outlet, and the proximal end is configured to be introduced into the internal volume and mechanically connected to the outlet during expansion of the slender expandable body.

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 mate with a recess in the outlet.

40. A chamber according to any one of claims 36 or 37, wherein the at least one slender flexible tube needle is integrated with the slender expandable body and is positioned within the internal volume during insertion of the slender expandable body into the body cavity, wherein the at least one slender flexible tube needle is configured to fold into two or more partially overlapping annular portions when the slender expandable body is in a collapsed state, and to expand into a single annular portion when the slender expandable body is unfolded in the body cavity.

41. A chamber according to any one of claims 36 to 40, wherein the at least one slender flexible tube needle comprises at least one outer tube needle and at least one inner tube needle, wherein when the slender expandable body is in an expanded state, the at least one outer tube needle pushes the fluid permeable wall outward, and the at least one inner tube needle is positioned between the at least one outer tube needle and the center point of the internal volume.

42. A chamber according to any one of claims 36 to 41, comprising a slender deployment tool having a distal end and a proximal end, wherein the distal end is reversibly connected to the at least one flexible slender tube needle and / or the slender expandable body, and the proximal end is positioned outside the body cavity, wherein movement of the proximal end applies a force on the at least one flexible slender tube needle and / or the slender expandable body sufficient to cause the slender expandable body to expand in the body cavity.

43. A chamber according to claim 42, wherein the slender deployment tool comprises at least one slender rod, which passes through the outlet and enters the internal volume, wherein the at least one slender rod has a distal end and a proximal end, the distal end is reversibly connected to the at least one flexible elongated tube needle, and the proximal end is located outside the body cavity, wherein axial advancement and / or rotation of the proximal end causes the at least one flexible elongated tube needle to move from a collapsed state to an expanded state.

44. The chamber of claim 42, wherein the outlet comprises at least two outlet openings, and wherein the elongated deployment tool comprises at least two elongated rods, each of the at least two elongated rods passing through a different one of the at least two outlet openings into the interior volume; Wherein, when the elongated expandable body is located within the body cavity, movement of the proximal ends of the at least two elongated shafts relative to each other exerts a force on the fluid permeable wall sufficient to expand the elongated expandable body in the body cavity.

45. The chamber of claim 42, wherein the elongated deployment tool comprises at least two elongated rods reversibly functionally coupled to the elongated expandable body at opposite sides of the elongated expandable body; Wherein, when the elongated expandable body is located within the body cavity, movement of the proximal ends of the at least two elongated rods relative to each other exerts a force on the elongated expandable body sufficient to expand the elongated expandable body in the body cavity.

46. ​​The chamber of claim 42, wherein the elongated deployment tool comprises an expansion tray, wherein the expansion tray comprises an elongated plate, at least two arms pivotally coupled to the tray at opposite sides of the tray, and at least one elongated actuation rod functionally coupled to the at least two arms, wherein the at least two arms are configured to reversibly couple to opposite sides of the elongated expandable body; wherein when the chamber is positioned within the body cavity, movement of a portion of the at least one elongated actuator rod located outside the body cavity causes the arm to move from a first state in which the arm is substantially aligned with the long axis of the tray to a second state in which the arm extends laterally from the plate while being reversibly coupled to the opposite side of the elongated expandable body, thereby causing the elongated expandable body to expand within the body cavity.

47. The chamber of any one of claims 36 to 46, wherein the chamber is adapted for implantation into a non-insufflated body cavity.

48. The chamber of claim 47, wherein the non-insufflated body cavity comprises a non-insufflated abdominal cavity, and wherein in the collapsed state, the elongated expandable body is shaped and sized to pass through an opening in the abdominal wall into the non-insufflated abdominal cavity, and wherein in the expanded state, the elongated expandable body is thin and has a surface area that is at least 5 times the surface area of ​​the elongated expandable body in the collapsed state.

49. The chamber of any one of claims 36 to 48, wherein the fluid permeable wall comprises at least one membrane layer having pores with a size ranging between 0.1 μm and 100 μm.

50. A fluid extraction chamber adapted for implantation into a body cavity, the fluid extraction chamber comprising: an expandable body configured to move from a collapsed state to an expanded state when deployed in the body lumen, wherein the expandable body comprises 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 to the interior volume; 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 in the circumference of the expandable body around the interior volume.

51. A method for deploying an elongated fluid extraction chamber, the method comprising: locally anesthetizing a subject's abdominal wall in an area selected as a target for forming an opening through the abdominal wall into a non-inflated abdominal cavity; forming the opening in the target area; introducing an elongated fluid extraction chamber in a collapsed state into the non-inflated abdominal cavity through the opening, the elongated fluid extraction chamber having a fluid permeable wall defining an interior volume and an outlet from the interior volume; The elongate fluid extraction lumen is expanded within the non-inflated abdominal cavity to obtain a surface area that is at least 5 times the surface area of ​​the elongate fluid extraction lumen in the collapsed state.

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

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

54. A method according to any one of claims 51 to 53, wherein the fluid extraction chamber includes an integrated tube needle, which is configured to move between a collapsed state and an expanded state, and wherein the expansion includes expanding the fluid extraction chamber by moving the tube needle to the expanded state.

55. The method of 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 to prevent the passage of fluid, and wherein the expanding comprises expanding the elongated fluid extraction chamber by injecting a fluid into the interior volume.

56. The method of any one of claims 51 to 55, comprising: Subsequent inflations of the negative pressure are intermittently applied to the interior volume through the outlet port, the negative pressure being sufficient to draw fluid from the non-inflated abdominal cavity into the interior volume through the fluid permeable wall and out of the interior volume through the outlet port.

57. The method of any one of claims 51 to 56, comprising: Prior to the local anesthesia, the subject is diagnosed with chronic heart failure or acute heart failure.

58. The method of any one of claims 51 to 56, comprising: Before the local anesthesia, ascites is detected in the subject.

59. The method of any one of claims 51 to 56, comprising: detecting protein-bound uremic toxins (PBUT) in the subject; Beads configured to bind to the PBUT are introduced into the interior volume after the expansion.

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