WO2024142070A1

WO2024142070A1 - Percutaneous ultrafiltration

Info

Publication number: WO2024142070A1
Application number: PCT/IL2023/051337
Authority: WO
Inventors: Nitai Hanani; Bar SHAYOVICH; Erez HOCHMAN; Dmitry MEDVEDOVSKY; Amir KERET
Original assignee: Paragate Medical Ltd.
Priority date: 2022-12-30
Filing date: 2023-12-28
Publication date: 2024-07-04

Abstract

A fluid extraction chamber suitable for implantation into a non-insufflated abdominal cavity, including: an elongated 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-insufflated abdominal cavity, wherein the elongated expandable body comprises a fluid permeable wall defining an internal volume of the elongated expandable body; wherein in a collapsed state the elongated expandable body is shaped and sized to penetrate through an opening in an abdominal wall into a non-insufflated abdominal cavity, and wherein in an expanded state the elongated expandable body is thin and has a surface area that is at least (5) times larger than a surface area of said elongated expandable body in the collapsed state; an outlet coupled to the elongated expandable body, having at least one opening to the internal volume.

Description

PERCUTANEOUS ULTRAFILTRATION

RELATED APPLICATION/S

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

FIELD AND BACKGROUND OF THE INVENTION

The present invention, in some embodiments thereof, relates to ultrafiltration device and methods and more particularly, but not exclusively, to a percutaneously implantable ultrafiltration device and methods.

SUMMARY OF THE INVENTION

Some examples of some embodiments of the invention are listed below (an embodiment may include features from more than one example and/or fewer than all features of an example): Example 1. A fluid extraction chamber suitable for implantation into a non-insufflated abdominal cavity, comprising: an elongated 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 said non-insufflated abdominal cavity, wherein said elongated expandable body comprises a fluid permeable wall defining an internal volume of the elongated expandable body; wherein in a collapsed state said elongated expandable body is shaped and sized to penetrate through an opening in an abdominal wall into a non-insufflated abdominal cavity, and wherein in an expanded state said elongated expandable body is thin and has a surface area that is at least 5 times larger than a surface area of said elongated expandable body in said collapsed state; an outlet coupled to said elongated expandable body, having at least one opening to said internal volume.

Example 2. A chamber according to example 1, wherein said chamber is suitable for implantation into said non-insufflated abdominal cavity under local anesthesia.

Example 3. A chamber according to any one of examples 1 or 2, wherein a maximal width of said elongated expandable body in said expanded state is at least 3 times larger than a maximal width of said elongated expandable body in said collapsed state. Example 4. A chamber according to any one of the previous examples, comprising an elastic porous skeleton in said internal volume contacting an inner surface of said fluid permeable wall, wherein said elastic porous skeleton is configured to apply force against said inner surface, to collapse when said elongated body is in a collapsed state, and to expand when said elongated expandable body is in an expanded state when deployed in said non-insufflated abdominal cavity.

Example 5. A chamber according to example 4, wherein said elastic porous skeleton comprises at least one layer of an elastic semi-rigid mesh.

Example 6. A chamber according to any one of examples 4 or 5, wherein said elastic porous skeleton is shaped as a sponge.

Example 7. A chamber according to any one of examples 4 to 6, wherein pores in said elastic porous skeleton have a similar size and/or shape.

Example 8. A chamber according to any one of examples 4 to 6, wherein pores in said elastic porous skeleton have a varying size and/or shape.

Example 9. A chamber according to any one of examples 4 to 8, wherein said elastic porous skeleton comprises an auxetic structure and/or an auxetic material, configured to allow expansion of the elastic porous skeleton when the elastic porous skeleton is stretched.

Example 10. A chamber according to any one of examples 4 to 9, wherein said elastic porous skeleton comprises integrated flow paths converging in said outlet, and wherein said integrated flow paths are shaped and sized to direct fluid entering said internal volume through different parts of the body towards said outlet.

Example 11. A chamber according to any one of the previous examples, wherein a thickness of said body in an expanded state is smaller than 2 mm.

Example 12. A chamber according to any one of the previous examples, wherein a ratio between a width and a length of said body in an expanded state is at least 1: 1.5.

Example 13. A chamber according to any one of the previous examples, wherein a ratio between a length and a width of said elongated expandable body, in said collapsed state is at least 5: 1.

Example 14. A chamber according to any one of the previous examples, wherein a maximal width of said elongated expandable body in said collapsed state is smaller than 10 mm. Example 15. A chamber according to any one of the previous examples, wherein in said expanded state, said body comprises a flexible stylet configured to outwardly push said fluid permeable wall.

Example 16. A chamber according to example 15, wherein said flexible stylet is integrated in said body.

Example 17. A chamber according to example 15, wherein said body comprises a circumferential channel configured to receive said flexible stylet, and wherein said flexible stylet is configured to be inserted through said outlet into said circumferential channel via said outlet, when said elongated expandable body is within said abdominal cavity.

Example 18. A chamber according to example 15, wherein said flexible stylet is configured to be inserted into said internal volume via aid outlet.

Example 19. A chamber according to any one of examples 15 to 18, wherein said flexible stylet is a bi-state flexible stylet configured to move between a collapsed state and an expanded state.

Example 20. A chamber according to any one of the previous examples, comprising a jacket placed around said elongated expandable body when said elongated expandable body is in said collapsed state.

Example 21. A chamber according to example 20, wherein said jacket is configured to increase a rigidity of said elongated expandable body in said long axis direction.

Example 22. A chamber according to any one of examples 20 or 21, comprising one or more threads coupled to said jacket, configured to allow removal of said jacket form said elongated expandable body from outside said abdominal cavity.

Example 23. A chamber according to any one of examples 20 to 22, wherein said jacket is formed from a dissolvable material, configured to dissolve when interacting with fluids in said abdominal cavity.

Example 24. A chamber according to any one of the previous examples, wherein an inner surface of said fluid permeable wall facing said internal volume is coated with a degradable coating configured to seal said fluid permeable wall from passage of fluids through said fluid permeable wall.

Example 25. A chamber according to example 24, wherein said coating is a hydrophobic coating. Example 26. A chamber according to any one of the previous examples, comprising a perforated tube coupled to said outlet and extending into said internal volume.

Example 27. A chamber according to any one of the previous examples, wherein said wall comprises at least one membrane layer having pores with a size in a range between 0.1 pm and 100 pm.

Example 28. A chamber according to any one of the previous examples, wherein said fluid permeable wall is formed at least partly from at least two types of membranes, wherein pores of at least one membrane of said at least two membrane types are configured to open to allow passage of fluid under pressure levels that are different form pressure levels needed for opening of pores of at least one second membrane of said at least two membrane types.

Example 29. A chamber according to any one of the previous examples, wherein said outlet comprises at least one flow path and a filter valve in said flow path, wherein said filter valve is configured to allow passage of fluids when said valve is closed, and to be opened when a tool is inserted through the outlet towards said internal volume.

Example 30. A chamber according to any one of the previous examples, wherein said outlet comprises at least two separate flow paths into said internal volume, wherein at least one flow paths is used for extraction of fluids out from said internal volume, and wherein at leats one second flow path is used for introducing of toxin binding beads into said internal volume.

Example 31. A fluid removal system, comprising: a chamber according to claim 1 ; an inflatable seal comprising at least one tube crossing said inflatable seal, wherein said tube is configured to be fluidically coupled to said outlet, and wherein said inflatable seal is configured to be positioned in said abdominal wall opening, and to seal gaps between said abdominal wall and said tube when inflated.

Example 32. A fluid removal system, comprising: a chamber according to claim 1 ; a tube configured to cross said abdominal wall through said opening, wherein at least one end of said tube is coupled to said outlet, and wherein at least one second end of said tube is configured to be positioned outside the body of the patient, wherein said tube comprises at least two separate channels passing within said tube, wherein an end of at least one first channel of said at lets two separate channels is fluidically coupled to said outlet, and wherein an end of at least one second channel of said at least two separate channels is fluidically coupled to said noninsufflated abdominal cavity.

Example 33. A system according to example 32, wherein said at least one second channel is a tool channel configured to allow insertion of a tool from outside the body into the abdominal cavity while said at least one first channel is fluidically coupled to said outlet.

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

Example 35. A seal according to example 34, wherein said expandable body comprises a balloon and an inflation port of said balloon.

Example 36. A seal according to any one of examples 34 or 35, wherein said tube comprises at least two separate flow paths.

Example 37. A fluid extraction chamber suitable for implantation into an abdominal cavity, comprising: an expandable body configured to move from a collapsed state to an expanded state, wherein said expandable body comprises a fluid permeable wall comprising at least one layer of a porous membrane, wherein said fluid permeable wall defines an internal volume of the body, wherein an inner layer of said fluid permeable wall is coated with a degradable coating; wherein in a collapsed state said expandable body is shaped and sized to penetrate through an opening in an abdominal wall into an abdominal cavity, and to expand within said abdominal cavity by injection of fluids into said internal volume, and wherein said degradable coating is configured to temporary seal pores of said membrane from passage of said injected fluids out from said internal volume through said fluid permeable wall.

Example 38. A chamber according to example 37, wherein said coating is a hydrophobic coating.

Example 39. A method for deploying an elongated fluid extraction chamber, comprising: locally anesthetizing a region in the abdominal wall of a subject selected as a target for forming an opening through the abdominal wall into a non-inflated abdominal cavity; forming said opening in said target region; introducing an elongated fluid extraction chamber having a fluid permeable wall defining an internal volume and an outlet of said internal volume, in a collapsed state into said non-inflated abdominal cavity through said opening; expanding said elongated fluid extraction chamber within said non-inflated abdominal cavity to acquire a surface area that is at least 5 times larger than a surface area of said elongated fluid extraction chamber in said collapsed state.

Example 40. A method according to example 39, wherein said expanding comprises expanding said elongated fluid extraction chamber to have an external flat surface and a thickness smaller than 2 mm.

Example 41. A method according to any one of examples 39 or 40, wherein said expanding comprises expanding said elongated fluid extraction chamber by introducing a stylet into said internal volume or into a circumferential channel in said fluid permeable wall.

Example 42. A method according to any one of examples 39 to 41, wherein said fluid extraction chamber comprises an integrated stylet configured t move between a collapsed state and an expanded state, and wherein said expanding comprises expanding said fluid extraction chamber by moving said stylet into an expanded state.

Example 43. A method according to any one of examples 39 to 42, wherein an inner layer of said fluid permeable wall comprises a degradable sealing layer configured to temporary seal said fluid permeable wall from passage of fluid, and wherein said expanding comprises expanding said elongated fluid extraction chamber by injecting fluids into said internal volume.

Example 44. A method according to any one of examples 39 to 43, comprising: applying following said expanding negative pressure intermittently on said internal volume through said outlet which is sufficient to draw fluid from said non-inflated abdominal cavity into said internal volume through said fluid permeable wall and out from said internal volume through said outlet.

Example 45. A method according to any one of examples 39 to 44, comprising: diagnosing said subject with a chronic heart failure or with acute heart failure prior to said locally anesthetizing.

Example 46. A method according to any one of examples 39 to 44, comprising: detecting ascites in said subject prior to said locally anesthetizing. Example 47. A method according to any one of examples 39 to 44, comprising: detecting Protein-Bound Uremic Toxins (PBUT) in said subject; introducing beads configured to bind said PBUT into said internal volume following said expanding.

Below are some additional examples of some embodiments of the invention are listed below (an embodiment may include features from more than one example and/or fewer than all features of an example):

Example 1. A fluid extraction chamber suitable for implantation into a non-insufflated abdominal cavity, comprising: an elongated 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 said non-insufflated abdominal cavity, wherein said elongated expandable body comprises a fluid permeable wall defining an internal volume of the elongated expandable body; wherein in a collapsed state said elongated expandable body is shaped and sized to penetrate through an opening in an abdominal wall into a non-insufflated abdominal cavity, and wherein in an expanded state said elongated expandable body is thin and has a surface area that is at least 5 times larger than a surface area of said elongated expandable body in said collapsed state; an outlet coupled to said elongated expandable body, having at least one opening to said internal volume.

Example 3. A chamber according to any one of examples 1 or 2, wherein a maximal width of said elongated expandable body in said expanded state is at least 3 times larger than a maximal width of said elongated expandable body in said collapsed state.

Example 4. A chamber according to any one of the previous examples, comprising an elastic porous skeleton in said internal volume contacting an inner surface of said fluid permeable wall, wherein said elastic porous skeleton is configured to apply force against said inner surface, to collapse when said elongated body is in a collapsed state, and to expand when said elongated expandable body is in an expanded state when deployed in said non-insufflated abdominal cavity.

Example 11. A chamber according to any one of the previous examples, wherein in said expanded state said elongated expandable body is substantially flat and thin, having a maximal thickness smaller than 2 mm along at least 90% of a width of the body.

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

Example 13. A chamber according to any one of the previous examples, wherein a ratio between a length and a width of said elongated expandable body, in said collapsed state is at least 3: 1.

Example 14. A chamber according to any one of the previous examples, wherein a maximal width of said elongated expandable body in said collapsed state is smaller than 10 mm.

Example 15. A chamber according to any one of the previous examples, wherein in said expanded state, said body comprises a flexible stylet configured to outwardly push said fluid permeable wall.

Example 18. A chamber according to example 15, wherein said flexible stylet is configured to be inserted into said internal volume via said outlet.

Example 20. A chamber according to any one of the previous examples, comprising a jacket placed around said elongated expandable body when said elongated expandable body is in said collapsed state, , wherein said jacket is configured to increase a rigidity of said elongated expandable body in said long axis direction.

Example 21. A chamber according to example 20, comprising one or more threads coupled to said jacket, configured to allow removal of said jacket form said elongated expandable body from outside said abdominal cavity.

Example 22. A chamber according to any one of examples 20 or 21, wherein said jacket is formed from a dissolvable material, configured to dissolve when interacting with fluids in said abdominal cavity.

Example 23. A chamber according to any one of the previous examples, wherein an inner surface of said fluid permeable wall facing said internal volume is coated with a degradable coating configured to seal said fluid permeable wall from passage of fluids through said fluid permeable wall.

Example 24. A chamber according to example 23, wherein said coating is a hydrophobic coating.

Example 25. A chamber according to any one of the previous examples, comprising a perforated tube coupled to said outlet and extending into said internal volume.

Example 26. A chamber according to any one of the previous examples, wherein said wall comprises at least one membrane layer having pores with a size in a range between 0.1 pm and 100 pm.

Example 27. A chamber according to any one of the previous examples, wherein said fluid permeable wall is formed at least partly from at least two types of membranes, wherein pores of at least one membrane of said at least two membrane types are configured to open to allow passage of fluid under pressure levels that are different form pressure levels needed for opening of pores of at least one second membrane of said at least two membrane types. Example 28. A chamber according to any one of the previous examples, wherein said outlet comprises at least one flow path and a fdter valve in said flow path, wherein said fdter valve is configured to allow passage of fluids when said valve is closed, and to be opened when a tool is inserted through the outlet towards said internal volume.

Example 29. A chamber according to any one of the previous examples, wherein said outlet comprises at least two separate flow paths into said internal volume, wherein at least one flow paths is used for extraction of fluids out from said internal volume, and wherein at leats one second flow path is used for introducing of toxin binding beads into said internal volume.

Example 30. A fluid removal system, comprising: a chamber according to claim 1 ; an inflatable seal comprising at least one tube crossing said inflatable seal, wherein said tube is configured to be fluidically coupled to said outlet, and wherein said inflatable seal is configured to be positioned in said abdominal wall opening, and to seal gaps between said abdominal wall and said tube when inflated.

Example 31. A fluid removal system, comprising: a chamber according to example 1; a tube configured to cross said abdominal wall through said opening, wherein at least one end of said tube is coupled to said outlet, and wherein at least one second end of said tube is configured to be positioned outside the body of the patient, wherein said tube comprises at least two separate channels passing within said tube, wherein an end of at least one first channel of said at lets two separate channels is fluidically coupled to said outlet, and wherein an end of at least one second channel of said at least two separate channels is fluidically coupled to said noninsufflated abdominal cavity.

Example 32. A system according to example 31, wherein said at least one second channel is a tool channel configured to allow insertion of a tool from outside the body into the abdominal cavity while said at least one first channel is fluidically coupled to said outlet.

Example 33. An expandable seal, comprising: an expandable body shaped and sized to be positioned within an opening in the abdominal wall and configured to move between a collapsed state and an expanded state; at least one tube crossing said expandable body comprising at least one opening configured to be positioned within an abdominal cavity and at least one opening configured to be positioned outside said abdominal cavity, wherein when said expandable body is configured to seal a gap between said abdominal wall and said at least one tube when expanded. Example 34. A fluid extraction chamber suitable for implantation into an abdominal cavity, comprising: an expandable body configured to move from a collapsed state to an expanded state, wherein said expandable body comprises a fluid permeable wall comprising at least one layer of a porous membrane, wherein said fluid permeable wall defines an internal volume of the body, wherein an inner layer of said fluid permeable wall is coated with a degradable coating; wherein in a collapsed state said expandable body is shaped and sized to penetrate through an opening in an abdominal wall into an abdominal cavity, and to expand within said abdominal cavity by injection of fluids into said internal volume, and wherein said degradable coating is configured to temporary seal pores of said membrane from passage of said injected fluids out from said internal volume through said fluid permeable wall.

Example 35. A chamber according to example 34, wherein said coating is a hydrophobic coating.

Example 36. A fluid extraction chamber suitable for implantation into a body cavity, comprising: an elongated expandable body configured to move from a collapsed state to an expanded state when deployed in said body cavity, wherein said elongated expandable body comprises a fluid permeable wall defining an internal volume of the elongated expandable body; an outlet coupled to said elongated expandable body, having at least one opening to said internal volume; at least one flexible elongated stylet positioned within said internal volume, and at least partly coupled to said outlet or to said body when said elongated expandable body is introduced into said body cavity, wherein said at least one flexible elongated stylet is configured to outwardly push said fluid permeable wall from within said internal volume to expand said elongated expandable body within said body cavity during said deployment of said elongated expandable body.

Example 37. A chamber according to example 36, wherein said elongated expandable body has a long axis and a short axis.

Example 38. A chamber according to any one of examples 36 or 37, wherein said at least one elongated flexible stylet comprises a distal end mechanically coupled to said outlet and a proximal end configured to be introduced into said internal volume during deployment of the elongated expandable body, and to be mechanically coupled to said outlet. Example 39. A chamber according to example 38, wherein said proximal end of said at least one elongated flexible stylet comprises an extension shaped and sized to match a recess in said outlet.

Example 40. A chamber according to any one of examples 36 or 37, wherein said at least one elongated flexible stylet is integrated with said elongated expandable body and positioned within said internal volume during insertion of said elongated expandable body into said body cavity, wherein said at least one elongated flexible stylet is configured to be folded into two or more partly overlapping ring-shaped portions, when said elongated expandable body is in a collapsed state, and to expand into a single ring-shaped portion when said elongated expandable body is deployed in said body cavity .

Example 41. A chamber according to any one of examples 36 to 40, wherein said at least one elongated flexible stylet comprises at least one outer stylet and at least one inner stylet, wherein when said elongated expandable body is in an expanded state, said at least one outer stylet pushes outwardly said fluid permeable wall and said at least one inner stylet is positioned between said at least one outer stylet and a center point of said internal volume.

Example 42. A chamber according to any one of examples 36 to 41, comprising an elongated deployment tool having a distal end reversibly coupled to said at least one flexible elongated stylet and/or to said elongated expandable body, and a proximal end positioned outside said body cavity, wherein movement of said proximal end applies force on said at least one flexible elongated stylet and/or on said elongated expandable body which is sufficient to expand said elongated expandable body in said body cavity.

Example 43. A chamber according to example 42, wherein said elongated deployment tool comprises at least one elongated rod passing through said outlet into said internal volume, wherein said at least one elongated rod has a distal end reversibly coupled to said at least one flexible elongated stylet, and a proximal end located outside said body cavity, wherein axial advancement and/or rotation of said proximal end moves said at least one flexible elongated stylet from a collapsed state to an expanded state.

Example 44. A chamber according to example 42, wherein said outlet comprises at least two outlet openings, and wherein said elongated deployment tool comprises at least two elongated rods, each passes through a different outlet opening of said at least two outlet openings into said internal volume; wherein when said elongated expandable body is within said body cavity, movement of proximal ends of said at least two elongated rods relative to each other applies force on said fluid permeable wall which is sufficient to expand said elongated expandable body in said body cavity.

Example 45. A chamber according to example 42, wherein said elongated deployment tool comprises at least two elongated rods reversibly functionally coupled to said elongated expandable body at opposite sides of said elongated expandable body; wherein when said elongated expandable body is within said body cavity, movement of proximal ends of said at least two elongated rods relative to each other applies force on said elongated expandable body which is sufficient to expand said elongated expandable body in said body cavity.

Example 46. A chamber according to example 42, wherein said elongated deployment tool comprises an expanding tray, wherein said expanding tray comprises an elongated plate, at least two arms pivotally coupled to said tray at opposite sides of said tray, and at least one elongated actuating rod functionally coupled to said at least two arms, wherein said at least two arms are configured to be reversibly coupled to opposite sides of said elongated expandable body; wherein when said chamber is positioned within said body cavity, movement of a portion of said at least one elongated actuating rod located outside said body cavity moves said arms from a first state where said arms are substantially aligned with a long axis of said tray to a second state where said arms extend sideways from said plate while being reversibly coupled to said opposite sides of said elongated expandable body, thereby expanding said elongated expandable body within said body cavity.

Example 47. A chamber according to any one of examples 36 to 46, wherein said chamber is suitable for implantation into a non-insufflated body cavity.

Example 48. A chamber according to example 47 wherein said non-insufflated body cavity comprises a non-insufflated abdominal cavity, and wherein in said collapsed state said elongated expandable body is shaped and sized to penetrate through an opening in an abdominal wall into said non-insufflated abdominal cavity, and wherein in said expanded state said elongated expandable body is thin and has a surface area that is at least 5 times larger than a surface area of said elongated expandable body in said collapsed state.

Example 49. A chamber according to any one of examples 36 to 48, wherein said fluid permeable wall comprises at least one membrane layer having pores with a size in a range between 0.1 pm and 100 pm.

Example 50. A fluid extraction chamber suitable for implantation into a body cavity, comprising: an expandable body configured to move from a collapsed state to an expanded state when deployed in said body cavity, wherein said expandable body comprises a fluid permeable wall defining an internal volume of the expandable body; an outlet coupled to said expandable body, having at least one opening to said internal volume; wherein said 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 a circumference of said expandable body surrounding said internal volume.

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

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

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

Any combination of one or more computer readable medium(s) may be utilized for some embodiments of the invention. The 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, apparatus, or device, or any suitable combination of the foregoing. More specific examples (a non-exhaustive list) of the computer readable storage medium would include the following: an electrical connection having one or more wires, a portable computer diskette, a hard disk, a random access memory (RAM), a read-only memory (ROM), an erasable programmable read-only memory (EPROM or Flash memory), an optical fiber, a portable compact disc read-only memory (CD-ROM), an optical storage device, a magnetic storage device, or any suitable combination of the foregoing. In the context of this document, a computer readable storage medium may be any tangible medium that can contain, or store a program for use by or in connection with an instruction execution system, apparatus, or device.

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, electro-magnetic, 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.

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.

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

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

These computer program instructions may also be stored in a computer readable medium that can direct a computer, other programmable data processing apparatus, or other devices to function in a particular manner, such that the instructions stored in the computer readable medium produce an article of manufacture including instructions which implement the function/act specified in the flowchart and/or block diagram block or blocks.

The computer program instructions may also be loaded onto a computer, other programmable data processing apparatus, or other devices to cause a series of operational steps to be performed on the computer, other programmable apparatus or other devices to produce a computer implemented process such that the instructions which execute on the computer or other programmable apparatus provide processes for implementing the functions/acts specified in the flowchart and/or block diagram block or blocks.

Some of the methods described herein are generally designed only for use by a computer, and may not be feasible or practical for performing purely manually, by a human expert. A human expert who wanted to manually perform similar tasks, such as determine pressure and/or changes thereof, and modify operation of a pump, might be expected to use completely different methods, e.g., making use of expert knowledge and/or the pattern recognition capabilities of the human brain, which would be vastly more efficient than manually going through the steps of the methods described herein.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

Some embodiments of the invention are herein described, by way of example only, with reference to the accompanying drawings. With specific reference now to the drawings in detail, it is stressed that the particulars shown are by way of example and for purposes of illustrative discussion of embodiments of the invention. In this regard, the description taken with the drawings makes apparent to those skilled in the art how embodiments of the invention may be practiced.

In the drawings:

FIG. 1 is a flow chart of a process for expanding an elongated fluid extraction chamber within a body cavity, according to some exemplary embodiments of the invention;

FIGs. 2A and 2B are block diagrams of a fluid extraction system having an elongated fluid extraction chamber in a collapsed state, for example in a folded state (Fig. 2A) and in an expanded state (Fig. 2B), for example an unfolded state, according to some exemplary embodiments of the invention;

FIGs. 2C and 2D are schematic illustrations of a fluid extraction chamber in a collpased state (Fig. 2C) and in an expanded state (Fig. 2D), according to some exemplary embodiments of the invention;

FIGs. 2E and 2F are schematic cross section views of figs. 2C and 2D respectively, according to some exemplary embodiments of the invention;

FIGs. 2G-2I are schematic illustrations showing a wall of the fluid extraction chamber, for example a membrane of said fluid extraction chamber, folded in different folding patterns, for example to acquire a collapsed and compact state of the fluid extraction chamber, according to some exemplary embodiments of the invention;

FIGs. 21 and 2K are schematic illustrations of a cross-section view of a fluid extraction chamber in an expanded state, according to some exemplary embodiments of the invention;

FIGs. 3A and 3B are schematic illustrations of a fluid extraction chamber in a folded state (Fig. 3A), and in a deployed state (Fig. 3B), according to some exemplary embodiments of the invention;

FIG. 3C is a schematic illustration of a chamber deployment process through two body openings, according to some exemplary embodiments of the invention; FIG. 3D is a schematic illustration of a chamber deployment process through A single body openings, according to some exemplary embodiments of the invention;

FIG. 3E is a flow chart of a process for chamber deployment via two body openings, according to some exemplary embodiments of the invention;

FIG. 3F is a flow chart of a process for chamber deployment via a single body openings, according to some exemplary embodiments of the invention;

FIG. 3G is a schematic illustration of a chamber deployed inside an abdominal cavity, according to some exemplary embodiments of the invention;

FIGs. 4A-4C are schematic illustrations showing expansion of a fluid extraction device using a bi-state stylet, according to some exemplary embodiments of the invention;

FIGs. 4D-4E are schematic illustrations of a wall of a fluid extraction device, according to some exemplary embodiments of the invention;

FIGs. 4F-4H are schematic illustrations of types of a perforated layer in a wall of a fluid extraction device, according to some exemplary embodiments of the invention;

FIGs. 5A and 5B are schematic illustrations showing a fluid extraction chamber having an inner hydrophobic portion in a collapsed state (FIG. 5A) and in an expanded state (FIG. 5B), according to some exemplary embodiments of the invention;

FIG. 5C is a schematic illustration of a perforated tube, according to some exemplary embodiments of the invention;

FIGs. 5D and 5E are schematic illustrations of layers of a wall of the fluid extraction chamber shown in figs. 5D and 5E, according to some exemplary embodiments of the invention;

FIGs. 6 A and 6B are schematic illustrations showing a fluid extraction chamber having an integrated stylet, according to some exemplary embodiments of the invention;

FIG. 7 is a schematic illustration of an expandable body opening seal, according to some exemplary embodiments of the invention;

FIGs. 8A-8C are schematic illustrations of a fluid extraction chambers having a wall with two or more filtration phases, according to some exemplary embodiments of the invention;

FIGs. 9A-9C are schematic illustrations of an access tube for an inner-cavity device having at least one additional flow path into the cavity, according to some exemplary embodiments of the invention;

FIGs. 10A and 10B are schematic illustrations showing release of material absorbing beads into an internal lumen of a fluid extraction chamber, according to some exemplary embodiments of the invention; FIG. IOC is a schematic illustration of a cross-section of a fluid extraction chamber, according to some exemplary embodiments of the invention;

FIG. 10D is a schematic illustration of a cross-section made in a fluid extraction chamber showing that two portions of at least one membrane layer are welded together via an intermediate porous layer along at least one seam line in a circumference of the chamber body which surrounds an inner volume of the chamber, according to some exemplary embodiments of the invention;

FIGs, 11A-11D are schematic illustrations showing a fluid extraction chamber having an insertable flexible scaffold, according to some exemplary embodiments of the invention;

FIGs. 12A and 12B are schematic illustrations showing a fluid extraction chamber having an integrated flexible scaffold according to some exemplary embodiments of the invention;

FIG. 13A is a schematic illustration showing a fluid extraction chamber having an integrated flexible scaffold comprising at least two flexible stylets optionally independent stylets, according to some exemplary embodiments of the invention;

FIG. 13B is a schematic illustration showing the fluid extraction chamber of FIG. 13A when resisting pressure applied by an organ or tissue on the fluid extraction chamber by allowing an outer stylet to flex while an inner stylet keeps an inner volume of the chamber open, according to some exemplary embodiments of the invention;

FIGs. 14A-14C are schematic illustrations showing expansion of a fluid extraction chamber having an internal scaffold using an external bar reversibly coupled to the internal scaffold, according to some exemplary embodiments of the invention;

FIGs. 14D-14G are schematic illustrations showing decoupling of an external bar from an internal scaffold of a fluid extraction chamber after expansion of the chamber, according to some exemplary embodiments of the invention;

FIGs. 15A-15C are schematic illustrations showing expansion of a fluid extraction chamber having an internal scaffold using at least two external bars having a distal end positioned within an internal lumen of the fluid extraction chamber and a proximal end outside the internal lumen, according to some exemplary embodiments of the invention;

FIGs. 16A-16C are schematic illustrations showing expansion of a fluid extraction chamber having an internal scaffold using at least two external bars functionally coupled to an outer surface of the fluid extraction chamber, according to some exemplary embodiments of the invention; FIGs. 17A-17C are schematic illustrations showing expansion of a fluid extraction chamber having an internal scaffold using an expanding tool comprising an expanding tray, according to some exemplary embodiments of the invention;

FIGs. 17D and 17E are schematic illustrations showing a mechanism for moving arms of the expanding tray shown in FIGs. 17A-17C, according to some exemplary embodiments of the invention; and

FIG. 18 is a flow chart of a process for deployment of a fluid extraction chamber in a body cavity using an expanding tool, according to some exemplary embodiments of the invention.

DESCRIPTION OF SPECIFIC EMBODIMENTS OF THE INVENTION

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

According to some embodiments, when expanded within the body cavity, for example the non-insufflated body cavity, the elongated fluid extraction device is used for removal of fluids found within the body cavity using fdtration, for example ultrafdtration. In some embodiments, fluids within the body cavity enter through pores into the fluid extraction device internal lumen, and are removed through the outlet, out from the patient body. In some embodiments, the fluids are removed from the body cavity when vacuum is applied on the device internal volume, leading to suction of the body cavity fluids into the internal volume.

According to some embodiments, when expanded within the body cavity, a body of the elongated fluid extraction device bridges between two spaced-apart regions, for example ends of the body cavity, located at a distance of at least 5 cm from each other. In some embodiments, in an expanded state the body of the elongated fluid extraction device has a length of at least 5 cm, at least 10 cm, at least 15 cm, at least 20, at least 25 cm, or any intermediate, smaller or larger value. In some embodiments, the body is configured to expand laterally within the body cavity. Optionally, lateral expansion of the body increase a width of body in at least two times, at least 3 times, at least 4 times, or any intermediate, smaller or larger value, relative to width of the body in the collapsed state when introduced through the opening into the body cavity. Optionally, when the body expands laterally within the body cavity, a length of the body changes in less than 1.5, for example less than 1.4, less than 1.2, or any intermediate, smaller or larger value relative to a length of the body when the device is in a collapsed state.

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

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

A potential advantage of having an elongated expandable fluid extraction chamber for removal of fluids may be to allow a large surface area when the device expands within the body cavity for fluid filtration and removal while maintaining a low profile of the chamber in a collapsed state.

An additional potential of having an elongated fluid extraction chamber for removal of fluids may be to allow fluid removal from spaced apart regions of the body cavity. An aspect of some embodiments relates to a fluid extraction chamber having two or more types of pores configured to open under different pressure thresholds. In some embodiments, at least one type of pores is configured to be opened, when a pressure level within the internal volume of the fluid extraction chamber is higher than a pressure threshold needed for a different type of pores of the device to be opened.

According to some embodiments, the two or more types of pores are located at different regions of the chamber, for example at 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 pores is located at a different membrane or layer of the chamber wall.

A potential advantage of having two types of pores may be to allow continuous fluid filtration even if one type of pores is clogged.

An aspect of some embodiments relates to removing molecules, for example toxins, from fluid within a body cavity using particles, for example beads, introduced into an internal lumen of a fluid extraction chamber. In some embodiments, the beads are located within the chamber internal lumen when deployed, or are introduced into the internal lumen of an already deployed chamber following deployment. In some embodiments, the beads are introduced into the chamber internal lumen, when an indication that a concentration of one or more toxins in the body cavity fluids increase.

According to some embodiments, the beads are removed from the internal volume of the chamber via an outlet of the chamber, for example using suction. Optionally, following removal of the beads, the beads are replaced with new beads. Alternatively, the beads remain in the internal volume of the chamber and are removed from the body cavity with the removal of the chamber.

An aspect of some embodiments relates to expansion of a collapsed fluid extraction chamber having a fluid permeable wall defining an internal volume, in a body cavity by introducing, for example injecting, fluids into the internal volume, by temporary sealing the fluid permeable wall. In some embodiments, the fluid permeable wall is sealed with a degradable, also termed herein as resorbable, for example a biodegradable material. In some embodiments, the biodegradable material is applied as a coating, for example a hydrophobic coating, on an external surface of the fluid permeable wall. Alternatively or additionally, the biodegradable material is applied as a coating, for example a hydrophobic coating, on the inner surface of the fluid permeable wall.

According to some embodiments, injection of fluids into the internal volume degrade the coating. In some embodiments, the sealing coating is degraded by hydrolysis. An aspect of some embodiments relates to treating a patient diagnosed with heart failure, for example chronic or acute heart failure, by introducing a fluid extraction chamber into a noninsufflated 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 abdominal cavity of the patient is detected prior to the introducing of the fluid extraction chamber. In some embodiments, the fluid extraction chamber comprises a fluid permeable wall defining an internal volume. In some embodiments, application of negative pressure, optionally intermittently, on the internal volume draws fluid from the abdominal cavity into the internal volume of the chamber. In some embodiments, the fluid drawn into the internal volume of the chamber is removed out from the patient body via an outlet tube fluidically coupled to the internal volume.

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

According to some embodiments, the elongated expanding tool is functionally coupled to an outer surface of the chamber body. Alternatively or additionally, the elongated expanding tool is positioned within an internal volume, for example an inner lumen of the chamber. In some embodiments, the elongated expanding tool is inserted into the internal volume via at least one outlet, of the chamber. In some embodiments, the elongated expanding tool is coupled, optionally reversibly coupled, to an inner scaffold within the internal volume. In some embodiments, the elongated expanding tool is configured to move the inner scaffold from a collapsed state to an expanded state, for example by applying force on the inner scaffold by axially moving and/or rotating the elongated expanding tool.

An aspect of some embodiments relates to forming a fluid extraction chamber body by adhering together two portions of at least one membrane layer by adhering, for example 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 together the two portions to the intermediate layer, for example to opposite sides of the intermediate layer.

According to some embodiments, the fixedly adhering of the two membrane portions forms and/or is along at least one seam line in a circumference of the chamber, that surrounds an internal volume of the chamber. In some embodiments, the at least one intermediate layer is a porous layer, for example not to interfere with fluid flow via the membrane into the chamber. Optionally, the at least one intermediate layer is a mesh layer. Optionally, the two portions of at least one membrane layer are adhered to each other via the intermediate layer, for example via pores in the intermediate layer. In some embodiments, the adhering of the two portions comprises adhering two separate layers of membrane to the at least one intermediate layer positioned therebetween, to form an enclosed body of a chamber having at least one outlet.

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

A general process for extracting fluids from a body cavity

According to some exemplary embodiments, a fluid extraction chamber is inserted into a body cavity of a subject, for example a patient, having excess fluids in the body cavity. In some embodiments, the excess fluids is a result of a clinical condition associate with a disease, for example heart failure, kidney disease, nephrotic syndromes, liver cirrhosis or cancer. Alternatively or additionally, the excess of fluids is a result, for example a side effect, of a treatment given to the patient such as excess diuretics that may lead to further kidneys 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 body of the patient is within a range of 3mm-15mm, for example 3mm-7mm, 5mm-10mm, 5mm-15mm or any intermediate, smaller or larger range of values. Optionally, the incision in the body is further dilated to a width value within a range of 6mm-30mm, for example 6mm- 12mm, 10mm- 17mm, 13mm-20mm, 17mm- 30mm or any intermediate, smaller or larger range of values

According to some exemplary embodiments, the extraction chamber is part of a system for fdtration, for example ultrafdtration of the fluids in or through the body cavity. As used herein ultrafiltration means withdrawal of fluids through at least one bodily membrane and filtration through at least one semipermeable membrane, under hydrostatic pressure or concentration (osmotic/oncotic) gradient. In some embodiments, an outlet of the chamber extends out from the patient body, for example through the incision used to introduce the chamber into the body cavity. According to some exemplary embodiments, the fluid extraction chamber remains in the body cavity while the outlet is outside the body for time periods 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 time periods. In some embodiments, the fluid extraction chamber is removed from the body cavity and is optionally replaced, when the level of fluid inside the body cavity is reduced below a predetermined value. Alternatively or additionally, the fluid extraction chamber is removed from the body cavity and is optionally replaced, when filtration efficiency is reduced below a predetermined value. Alternatively, the fluid extraction chamber is implanted in the patient body together with the outlet of the chamber and optionally a pump configured to generate and apply negative pressure on the internal volume of the fluid extraction chamber.

According to some exemplary embodiments, the fluid extraction chamber is part of fluid extraction system comprising the chamber, a pump and a control unit can be either fully implantable, for example in chronic patients, for example 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 partly implantable configuration the chamber is inside the body, and the pump and/or the outlet of the chamber are located outside the body of the patient. In some embodiments, for example as in cancer patients and/or in patients suffering from chronic kidney disease, only the chamber is implanted, while the pump, the control unit and the outlet of the chamber are located outside the patient body.

Reference is now made to fig. 1, depicting filtering of fluids from a body cavity, according to some exemplary embodiments of the invention.

According to some exemplary embodiments, excess systemic fluids are optionally identified systemically in a body or locally at a certain cavity, for example a pleural space cavity of a subject, at block 102. In some embodiments, the fluids are identified using an imaging system, for example x-ray or ultrasound imaging system. Alternatively, the fluid overload are identified by a physical and/or biochemical examination of the patient.

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

According to some exemplary embodiments, an opening is formed in the abdominal cavity, at block 106. In some embodiments, the opening is formed by forming an incision through the abdominal wall. In some embodiments, a length of the incision is in a range between 3 mm and 15 mm, for example within a range between 3 mm and 8 mm, within a range between 3 mm and 8 mm, within a range between 8 mm - 15 mm, or any intermediate, smaller or larger range of values. Optionally, the opening is formed prior to a laparoscopic procedure.

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

According to some exemplary embodiments, once the chamber is within the abdominal cavity, the chamber is expanded to acquire an expanded state, at block 110. In some embodiments, the chamber is expanded by introducing a stylet from outside the body into an internal volume of the chamber. Alternatively, the chamber is expanded by expanding a stylet, for example a bi-state stylet having a collapse state and an expanded state within the internal lumen of the chamber. Optionally, the expandable stylet is integrated in the body of the chamber. Optionally, the chamber expands when a dissolvable sleeve, for example a dissolvable jacket, is dissolved within the body cavity. In some embodiments, dissolving of the jacket which optionally applies force against the expandable stylet, leads to expansion of the stylet.

According to some exemplary embodiments, the chamber is expanded by introducing fluids from outside the body into the internal lumen of the chamber. In some embodiments, a hydrophobic core, for example a hydrophobic inner layer of the chamber wall expands the chamber when fluids are introduced into the internal lumen.

According to some exemplary embodiments, body fluids are filtered at block 112. In some embodiments, vacuum is applied on the internal volume of the chamber leading to entrance of fluids from the body cavity through pores in the wall of the chamber into the internal volume of the chamber. In some embodiments, suction generated by the applied vacuum forces extracts the fluids from the internal volume of the chamber, through at least one outlet of the chamber, optionally outside the patient body. According to some exemplary embodiments, filtration at block 112 is performed until pores of the chamber are clogged, leading to an increase in the applied vacuum forces and/or to a reduction in fluid flow through the chamber outlet. Optionally, during the filtration at block 112, when the applied vacuum forces are higher than a threshold level, at least one additional set of pores is opened leading to an increase in fluid flow through the outlet and optionally to a reduction in the applied vacuum forces.

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

According to some exemplary embodiments, once filtration is stopped, the device is optionally removed out from the body, at block 118. In some embodiments, the device is removed by either removing an inner stiffening spreading stylet and retrieving the loosened device from the given cavity, optionally using the outlet tubing as a service channel. Alternatively, a pre-inflated locking balloon is deflated to allow retrieval of the entire device. Alternatively, a mechanical state of the spreading stylet is changed by releasing it from its buckled position, or by using cold infusion to reduce stiffness of the device skeleton or spreading stylet. In some embodiments, the device is removed when the amount of fluid in the body cavity is lower than a predetermined value, and/or when pores of the device are clogged and the filtering is not efficient. Optionally, the device is replaced with a new device to continue with filtering, if needed.

According to some exemplary embodiments, a system which includes the device is optionally implanted, at block 116. In some embodiments, the system which includes the device and at least one pump is optionally implanted if there is a need for chronic fluid removal, for example for a time period larger than a week, for example for a time period larger than 2 weeks, 3 weeks, 1 month, or any intermediate, shorter or longer time period.

Exemplary fluid extraction chamber and system

According to some exemplary embodiments, a fluid extraction chamber is used to extract fluids from a body cavity. In some embodiments, the extracted fluid comprises one or more molecules that penetrate via pores of the fluid extraction chamber into an internal lumen of the chamber, and out from the body.

Reference is now made to figs. 2A and 2B, depicting a fluid extraction chamber and a fluid extraction system, respectively, according to some exemplary embodiments of the invention. According to some exemplary embodiments, a fluid extraction chamber 202 comprises an elongated body 204 having an internal volume 206 defined by a wall 208 of the elongated body 204. In some embodiments, the wall 208 comprises one or more layers of a membrane having one or more types of pores. In some embodiments, the one or more pores types have a size in a range of 0.1 pm (micron) to 0.5 pm, 0.5 pm to 10 pm or 10 pm -100 pm for small, medium or large range, respectively. Optionally, the wall 208 comprises two or more types of membranes, each having pores with a different size, for example a first type of pores having a size in a range of 0.1 pm -0.5 pm, and a second type of pores having a size in a range of 0.5 pm -10 pm or 10 pm -100 pm. Alternatively, the membrane can be hydrogel type or biological based, for example collagen. In some embodiments, an external layer promotes tissue embedment and revascularization on outer layer, where inner layer maintains impermeability to tissue. Alternatively, each membrane could be positioned in a different part of the wall, enabling different fluid filtration rates. Optionally, each membrane could be actuated individually to accommodate to various physiological conditions. In some embodiments, each of the membranes is characterized by different structure or hydrophilicity, while constructed with same porosity range.

According to some exemplary embodiments, one or more layers of the wall, for example membrane layers on the outer surface of the body, allow growth of cells and tissue on the outer surface of the chamber. In some embodiments, one or more inner layers of the wall, for example a layer facing the internal volume prevent the growth and/or penetration of tissue and cells into the internal volume.

According to some exemplary embodiments, the chamber 202 comprises at least one outlet 210, optionally a single outlet, from the internal volume 206. In some embodiments, the outlet 210 comprises at least one flow path, for example at least one channel. In some embodiments, when the chamber is deployed in the body cavity, vacuum is applied via the outlet 210 on the internal volume206 leading to negative pressure in the internal volume 206 and suction of fluid from the body cavity through pores in the wall 2087 into the internal volume 206, and out from the body via the outlet 210.

According to some exemplary embodiments, the chamber 202 optionally comprises a stylet 212, optionally an elastic stylet, within the internal volume 206 or attached at least partly to the inner surface of the wall 208. In some embodiments, the stylet 212 is configured to move between a collapsed state and an expanded state. In some embodiments, in an expanded state, the stylet 212 pushes the inner surface of the wall 208, leading to expansion of the body 204. In some embodiments, the stylet 212 is integrated in the body 204. Alternatively, the stylet 212 is insertable into the internal volume 216 or into the wall 208, for example into a circumferential channel in the wall 208, from outside the patient body, optionally through outlet 210.

According to some exemplary embodiments, when expanded the stylet 212 is configured to expand the body 204 to acquire any shape, for example a polygon shape, a rhombus shape, a deltoid shape, optionally according to a shape of the stylet 212 in an expanded state. In some embodiments, the stylet is pre-formed to acquire a specific shape upon expansion, for example when the stylet is a bi-state stylet configured to move from a collapsed compact elongated shape to the pre-formed shape upon expansion. Optionally, the stylet 212 , for example an integrated stylet, is formed from a shape memory alloy, for example Nitinol.

According to some exemplary embodiments, for example as shown in fig. 2A, in a collapsed state, the body 204 is placed within a sheet, for example a jacket 214. In some embodiments, the jacket 214 is configured to maintain body 204 in a collapsed, for example a folded state, optionally by applying a mechanical force on the outer layer of the wall 208 in a direction towards a center of the internal volume 206. Optionally, the applied force is equal or larger than a force applied by the stylet 212 on the inner surface of the wall 208.

According to some exemplary embodiments, for example as shown in fig. 2A, the body 204 is elongated having a long axis 216 and a short axis 218. In some embodiments, in a collapsed state, a length 220 of the body 204 is in a 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 range of values. In some embodiments, in a collapsed state, the maximal width 222 of the body 204, optionally a short axis of the body, is in a 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 range of values.

According to some exemplary embodiments, for example as shown in fig. 2B, in an expanded state, the body 204 expands, optionally laterally. In some embodiments, expansion of the body 204 increases the maximal width 222. In some embodiments, in an expanded state the maximal width 222 is in a 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 an expanded state, the maximal width 222 increases 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 increase ratio compared to the maximal width 222 when the body is collapsed. Optionally, in an expanded state, the length 220 is changed in a ratio between 1-1.5 compared to the length 220 in a collapsed state.

According to some exemplary embodiments, following expansion, the body 202 has an aspect ratio length-width value in a range between 1.2: 1 to 10: 1, for example 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 range of values. In some embodiments, a ratio between a width and a length of the body in an expanded state is at least 1: 1.2, for example a ration 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 ratio vane. In some embodiments, a thickness, optionally a minimal thickness of the body 202 in an expanded state, for example thickness 261 shown in fig. 2F, is smaller than 5 mm, for example smaller than 4 mm, smaller than 3 mm, smaller than 2 mm, smaller than 1 mm, or any intermediate, smaller or larger value.

According to some exemplary embodiments, the body 204 expands, for example, when the stylet 212 moves to an expanded state, pushing the inner surface of the wall 208. In some embodiments, the body 204 expands, when the jacket 214 is dissolved, for example by fluids in the body cavity.

According to some exemplary embodiments, the body 204 expands when fluids are introduced via the outlet 210 into the internal volume 206 causing the body 204 to inflate. Optionally, at least one inner layer of the wall 208 facing the internal volume 206 is coated with or comprises a hydrophobic material, optionally biodegradable hydrophobic material, for example Polylactic acids (PLA, PDLA, PLLA), polylactive-polyglycolide (PLGA), polyglycerolsebacate (PGS), or soluble glucose/glycogen based coating. In some embodiments, when fluids are introduced into the internal volume 206, two opposite hydrophobic portions of the wall repel the introduced fluids leading to outwardly expansion of the body 204 away from the fluids in the internal volume. Alternatively, expansion of 204 is achieved by high rate fluid injection through 210, above the flow rate of wall 208, causing the body of 204 to expand to its pre-shaped or skeleton supported form.

Alternatively or additionally, when the chamber 202 does not include the integrated stylet 212, a stylet is pushed into the internal volume 206 via at least one floe path in the outlet 210 leading to expansion of the body 204. In some embodiments, the body 204 expands by unfolding or unfurling of the body 204, for example a membrane forming the wall 208 of the body. In some embodiments, the body 204 or the chamber 202 comprises a stylet lock 205, configured to lock the stylet in a fixed state when the body 204 is in an expanded state.

According to some exemplary embodiments, the chamber 202 comprises an elastic support structure 213, for example an elastic skeleton, which is optionally porous within the internal volume 208 of the chamber. In some embodiments, the support structure comprises a mesh or a sponge and is configured to be in contact with the inner surface of the wall 208. In some embodiments, when the body 206 is in an expanded state the support structure 213 is compressed, and when the body 206 is in an expanded state, the support structure 213 expands. In some embodiments, during activation of the chamber and following deployment of the chamber 202, the support structure 213 is configured to maintain the body 202 at least partly expanded along at least 30% of the body 204 length 220, for example along at least 50% of the body length, along at least 60% of the body length, along at least 80% of the body length, or any intermediate, smaller or larger percentage value, for example by preventing collapse of the wall 208 onto the internal volume 206.

According to some exemplary embodiments, the support structure fdls at least 30% of the internal volume 216 of the body 204, for example at least 50% of the internal volume 216, at least 60% of the internal volume, at least 70% of the internal volume, at least 80% of the internal volume, at least 90% of the internal volume, or any intermediate, smaller or larger percentage value of the internal volume.

According to some exemplary embodiments, the support structure 213 is at least partly rigid, for example to provide mechanical support to the wall 208. In some embodiments, pores of the support structure 213 have a similar size or have a variable size. In some embodiments, the pores are distributed evenly or randomly in the support structure 213. In some embodiments, the support structure 213 comprises one or more layers of material having a structure of a mesh, a web, or a sponge. Optionally, at least part of the support structure comprises an auxetic structure and/or an auxetic material, configured to allow expansion of the support structure 213 when the support structure is stretched.

According to some exemplary embodiments, in a collapsed, for example a folded state, and in an expanded state, for example an unfolded or unfurled state, the elongated body 204 has a tubular, for example a cylindrical elongated shape.

According to some exemplary embodiments, in an expanded state, the wall 208 comprising the membrane, is flat, optionally substantially flat along, for example at least 80%, along at least 85%, along at least 90%, along at least 95% of a length of the wall 208. In some embodiments, in an expanded state, the body 204 is thin, having a maximal thickness smaller than 5 mm, for example a thickness smaller than 4 mm, smaller than 3 mm, smaller than 2 mm, smaller than 1 mm or any intermediate, smaller or larger value. In some embodiments, when the body 204 is expanded, a surface area of the wall outer surface is increased by at least 5 times, for example by at least 10 times, by at least 20 times, by at least 50 times, or any intermediate, smaller or larger value, compared to the surface area of the wall outer surface when the body 204 is in a collapsed state. In some embodiments, in an expanded state, a surface area of the wall facing the abdominal cavity is at least 200 cm², for example at least 300 cm² , at least 400 cm² , at least 500 cm², or any intermediate, smaller or larger value. According to some exemplary embodiments, for example as shown in fig. 2B, a system for fluid extraction, for example system 223, comprises the chamber 202 and a control unit 225. In some embodiments, the control unit 225 comprises a vacuum generator, for example a pump 224, coupled to the outlet 210 and configured to apply vacuum, for example negative pressure on the internal volume 206 via the outlet 210, for example via at least one channel in the outlet 210.

According to some exemplary embodiments, the control unit 225 comprises a memory 226 which stores at least one activation protocol of the pump, and/or one or more parameter values of the applied vacuum, for example timing for applying the vacuum and level of vacuum applied by the pump 224 on the internal volume 206. In some embodiments, the control unit 225 comprises a control circuitry 228, configured to control the activation of the pump, optionally based on the at least one activation protocol and/or the parameter values stored in the memory 226.

According to some exemplary embodiments, the control unit 225 comprises at least one sensor 230. In some embodiments, the at least one sensor 230 comprises a pressure sensor, configured to measure the pressure inside the internal volume 206, for example by measuring the pressure inside the outlet 210. Alternatively or additionally, the at least one sensor 230 comprises a flow sensor, configured to measure the flow of fluids via the outlet 210, out from the internal volume 206.

According to some exemplary embodiments, an end 232 of the outlet 232, for example a proximal end, is optionally coupled to an external chamber, configured to store the fluids extracted from the patient body via the outlet 110. Optionally, the control unit comprises a power source, for example a battery, configured to provide electric power for the activation of the pump 224. Optionally, the control unit is enclosed in a casing, that is configured to be implanted in the body of the patient. In some embodiments, the casing is thin and has flat surfaces.

According to some exemplary embodiments, the control unit 225 is configured to be completely implanted, partly implanted or external.

According to some exemplary embodiments, the control circuitry 228 is configured to activate the pump 224 intermittently in intervals between two consecutive activation phases where no pressure is applied on the internal volume of the chamber. In some embodiments, the control circuitry 228 is configured to activate the pump 224 for short time periods 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 periods. In some embodiments, an interval duration between two consecutive activation periods is within a range of 20 seconds and 360 seconds, for example within a range between 20 seconds and 40 seconds, within a range between 60 seconds and 300 seconds, or any intermediate, smaller or larger range of values. In such and other embodiments, the control unit 225 optimizes the interval timing to optimize the net drained volume, based on the compression and recoiling dynamics of the skeleton 213. Optionally, the skeleton 213 is configured to assist with the recoiling of the body into an expanded state when application of negative pressure is stopped, by elastically expending and applying force of the inner surface of the body. In some embodiments, the skeleton 213 is configured to allow controlled and/or regulated compression of the chamber body when vacuum is applied and controlled and/or regulated recoil of the chamber body back into an expanded state, when application of vacuum is stopped, for example during interval periods.

According to some exemplary embodiments, the pump, for example pump 224 comprises a gear pump, for example an internal gear pump or an external gear pump. A potential advantage of using a gear pump is that the gear, optionally movement of one or more cog wheels of the gear, dismantles proteins and/or other aggregates in the fluid, resulting with less risk for clogging of the tubes and/or pump.

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, electrically controlled valves are implemented as tube pinch or clamping elements.

Exemplary chamber with foldable body

Reference is now made to figs. 2E-2F depicting a chamber with a body in a folded state, and in an unfolded expanded state, according to some exemplary embodiments of the invention.

According to some exemplary embodiments, for example as shown in fig. 2C, a chamber 250 is in a collapsed state. In some embodiments, body 252 is coupled to an outlet 254 and is in a collapsed, for example folded state within a sleeve 256, serves as a jacket.

According to some exemplary embodiments, for example as shown in fig. 2E, which is a cross section along axis AA of the chamber 250, the body 252 is folded within the sleeve 256, such that the internal support structure 258 is compressed and optionally folded, and a tube 260 for example a fenestrated tube also termed herein as a perforated passes within the internal volume 262 of the body 252.

According to some exemplary embodiments, for example as shown in figs. 2D and 2F, in an expanded state, the body 252 is in an unfolded state, and support structure 258 is expanded. Additionally, a flexible stylet 264 is positioned within the internal volume 262, for example to maintain the body 252 is an expanded state. In some embodiments, a wall of the body is configured to move between a collapsed folded state to an expanded unfolded state. Optionally, the wall is formed from two or more layers, for example layers 268 and 270. Optionally, each of the layers ha s different fluid permeability and/or different rigidity.

According to some exemplary embodiments, for example as shown in figs. 2G-2I, a fluid permeable wall of the chamber, comprising a porous membrane, is configured to be folded in different ways in order to achieve a compact packing of the chamber, when the chamber is in a collapsed state. In some embodiments, this membrane folding allows, for example, allows minimal profile while preventing mechanical trauma to the membrane.

Reference is now made to fig. 2 J depicting a side view of a fluid extraction chamber body in an expanded state, according to some exemplary embodiments of the invention.

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

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

In some embodiments, the body 270 has a maximal thickness 279 of up to 3 mm, for example a maximal thickness of up to 2mm, a maximal thickness of up to 1 mm, a maximal thickness of up to 0.7 mm, or any intermediate, smaller or larger value, along at least 90% of an overall width 278 or of a surface area of the chamber body 270, along at least 95% of a width 278 or of a surface area of the chamber body 270, along at least 98% of a width 278 or of a surface area of the chamber body 270, or any intermediate, smaller or larger percentage value. In some embodiments, a thickness 280 of the body 270 in a portion 282 of the body, comprising the tube 276, is in a range between 2 mm and 8 mm, for example in a range between 2 mm and 4 mm, in a range between 3 mm and 6 mm, or any intermediate, smaller or larger value.

According to some exemplary embodiments, for example as shown in fig. 2K, during active fluid extraction, fluid enters into the internal volume 274 via a membrane in the wall 272, at thinner portions of the body 270 having a maximal thickness of up to 3 mm. Exemplary chamber implantation

According to some exemplary embodiments, the elongated chamber is introduced in a collapsed, for example folded state into the body cavity, for example into the abdominal cavity, via one or two openings in the body cavity wall.

Reference is now made to figs. 3A and 3B, depicting a fluid extraction chamber during implantation in a collapsed state in fig. 3A and in an expanded state in fig. 3B, according to some exemplary embodiments of the invention.

According to some exemplary embodiments, for example as shown in fig. 3A, the elongated fluid extraction chamber 302 is in a folded state, optionally within a sheet, for example a jacket. In some embodiments, the sheet optionally increases the rigidity of the chamber 302 in an axial direction, for example to assist in insertion of the chamber 302 through the opening in the body, and/or to prevent unwanted expansion, for example unfolding of the chamber 302 outside the body.

According to some exemplary embodiments, an atraumatic needle, such as a Veress needle, for example a spring activated Veress needle, or an introduction dilator is first introduced through the abdominal wall, for example form a percutaneous access into the abdominal cavity. In some embodiments, a trocar, for example a tunneling trocar 304 slid on a guide wire 306, is used to enlarge the opening in the abdominal cavity. In some embodiments, a torque, for example a connector between the guidewire and a tube is coupled to an outlet 310 of the chamber 302 is used to guide the chamber 302 into the abdominal cavity over the guide wire 306. In some embodiments, for example as shown in fig. 3B, during or prior to the deployment of the chamber 302 the guide wire 306, the trocar 304 and the torquer are decoupled from the chamber 302. In some embodiments, one or more securement threads 312 are coupled to the chamber 302. In some embodiments, the threads 312 are configured to be used in order 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, introducer and dilator shafts are introduced without the use of a tunneling trocar, where second percutaneous access is facilitated through a secondary incision and optionally use of graspers to grip the axial guidewire in a dual access approach, for example as shown in fig. 3C.

According to some exemplary embodiments, the elongated chamber is configured to be inserted into the abdominal cavity using two openings, in a dual access process, for example as shown in fig. 3C. Reference is now made to fig. 3E, depicting a process for insertion of the chamber into the abdominal cavity using the dual access process, according to some exemplary embodiments of the invention. According to some exemplary embodiments, an access to the cavity is formed in two position, at block 320. In some embodiments, the access to the cavity is formed in positions (i) and (e) shown in fig. 3C.

According to some exemplary embodiments, a guide wire is passed to a contralateral side (e) from site (i), at block 322.

According to some exemplary embodiments, the device, for example the chamber, is connected to the wire, at block 324.

According to some exemplary embodiments, the wire is pulled from position (e) to lead the chamber into the cavity, at block 326.

According to some exemplary embodiments, a sleeve surrounding the chamber in the collapsed state, for example a jacket, is pulled outward from access site (i), at block 328.

According to some exemplary embodiments, the chamber is expanded at block 330, optionally by injecting fluids into the device internal volume, and/or by inserting an expanding stylet, for example a stylet frame, and/or by changing position of an internally embedded frame or skeleton, or by a different method described in the application.

According to some exemplary embodiments, a stylet frame, used to expand a body of the chamber, for example body 204 or 302, is locked at block 332, optionally to affix the body in final form, for example in an expanded form.

According to some exemplary embodiments, the procedural accessories: a wire, tunneling guidewire or trocar and suture wires are removed, at block 334.

According to some exemplary embodiments, the elongated chamber is configured to be inserted into the abdominal cavity using a single opening, in a single access process, for example as shown in fig. 3D. Reference is now made to fig. 3F, depicting a process for insertion of the chamber into the abdominal cavity using the single access process, according to some exemplary embodiments of the invention.

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

According to some exemplary embodiments, a sheath and/or a guide wire is positioned inside the access site, at block 342.

According to some exemplary embodiments, the device is pushed through the sheath and/or the guide wire into the cavity, at block 344.

According to some exemplary embodiments, a jacket, for example a sleeve surrounding the chamber is outwardly removed through the access site, at block 346. Alternatively the jacket is resolved. 31

According to some exemplary embodiments, the chamber is expanded at block 348, optionally by injection of fluids into the internal volume of the chamber.

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

According to some exemplary embodiments, the wire and/or other elements used for insertion of the chamber are removed at block 352, at described at block 334.

According to some exemplary embodiments, the outlet channel, for example outlet 210 or 310 is optionally tunneled subcutaneously, for example to better secure the device in place.

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

Exemplary bi-state stylet

According to some exemplary embodiments, a fluid extraction chamber is expanded within the body cavity using a bi-state stylet, for example a bi-stable stylet, which is a stylet that can move between a collapsed state having a low profile that is suitable for insertion into a chamber in a collapsed state, and an expanded state that allows deployment of the chamber within the body cavity. In some embodiments, a chamber that includes the bi-stable stylet is used to extract fluids from patients suffering from Heart Failure, for example Chronic Heart Failure.

Reference is now made to figs. 4A-4C depicting expansion, for example deployment, of a fluid extraction chamber using a bi-state stylet, according to some exemplary embodiments of the invention.

According to some exemplary embodiments, for example as shown in fig. 4A a chamber 402, optionally in a form of a sac, is in a collapsed state within a jacket 404. In some embodiments, the chamber comprises at least one, for example a single, flow path in to the chamber and out from the chamber, for example outlet 401. In some embodiments, when the chamber 402 is introduced into the body cavity through an opening, for example as described in figs. 3A-3F, a bi-stable stylet 403 is introduced through the outlet 401 into the chamber 402, for example into an internal volume of the chamber. According to some exemplary embodiments, for example as shown in fig. 4B, the jacket 404 which optionally prevents expansion of the chamber is removed. In some embodiments, the jacket 404 is dissolved by fluids in the body cavity. Alternatively or additionally, the jacket 404 is dissolved by fluids injected from outside the body into the internal volume of the chamber or into the body cavity. In some embodiments, the jacket 404 is removed from the body through the same opening, used to insert the chamber into the body cavity or through a different opening.

According to some exemplary embodiments, for example as shown in fig. 4C, when the jacket 404 is removed, the bi-stable stylet 403 expands, optionally laterally, for example sideways, within the chamber 402, and pushes the inner surface of the chamber wall. In some embodiments, expansion of the stylet expands the chamber 402 to an expanded state. In some embodiments, for example as shown in fig. 4C, in an expanded state, the chamber body is narrow and has at least two flat surfaces, coated or comprising a porous membrane. Optionally, the at least two flat surfaces are planar. In some embodiments, a flat surface is a surface having bulges with a length of less than 2 mm, for example less than 1 mm, less than 0.5 mm or any intermediate, smaller or larger value, extending from the surface.

Reference is now made to figs. 4D and 4E, depicting a composition of a wall of the chamber, according to some exemplary embodiments of the invention.

According to some exemplary embodiments, for example as shown in fig. 4E, a wall of the chamber 402, comprises an inner layer and an outer layer of permeable membrane 421, and an inner core layer 423 of perforated media having fixed spacing 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.

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

A fluid extraction chamber having a hydrophobic core

According to some exemplary embodiments, a fluid extraction chamber comprises a wall having a hydrophobic layer configured to assist with the expansion of the chamber within the body cavity. According to some exemplary embodiments, a degradable hydrophobic coated inner layer allows the inflation of the chamber by injection of fluid. In some embodiments, this allows to prevent the permeable membrane itself to be distended and damaged due to the insufflation of fluid. In some embodiments, once the device is inflated a spreading stylet is inserted to maintain the device in shape after the hydrophobic core is absorbed by the fluid .Optionally, the device positioning is done via dual pull-pull wire mechanism, which also allows optionally pulling away the jacket. In some embodiments, the hydrophobic layer of the wall allows to initially expand the chamber using fluids injected into the internal volume through the outlet without a risk that the injected fluid will flow out through pores in the wall, for example through pores of a membrane within the wall. In some embodiments, once the hydrophobic layer is degraded, a stylet is introduced into the chamber to maintain the chamber in a stable expanded state.

A potential advantage of using fluids to initially expand the chamber may be to allow uniform expansion in all direction by the injected fluids that allows optionally to fit the shape of the expanded chamber to spaces within the body cavity, for example between organs.

According to some exemplary embodiments, the chamber with the hydrophobic core is used to achieve effective expansion of folded device to its final form, with minimal use of metallic skeletal portion, for example a stylet.

Reference is now made to figs. 5A-5C depicting a chamber with a hydrophobic core, according to some exemplary embodiments of the invention.

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

According to some exemplary embodiments, for example as shown in fig. 5B, which is a cross-section of the chamber 502, the chamber 502 comprises a tube, for example a perforated tube 514 passing through the outlet into an internal volume of the chamber, for example an internal volume of the filtration capsule 504. In some embodiments, during deployment a stylet 516 is pushed through the outlet 506 into the chamber 502. In some embodiments, the stylet is pushed into the internal volume of the filtration capsule 504, optionally, into a circumferential channel in a wall of the capsule. According to some exemplary embodiments, for example as shown in figs. 5D and 5E, a wall 520 of the filtration capsule consists of two layers, an outer layer 522 of permeable membrane and an inner support layer 524 comprising hydrophobic coating, for example resorbable hydrophobic coating for example to allow initial inflation. Alternatively, only the inner layer, which is made of stronger and stiffer material and structure than the outer layer, is coated with the resorbable hydrophobic coating. In some embodiments, the layers are connected in at least some points of the body, or along its perimeter, and hence move together with the inflation of the fluid.

According to some exemplary embodiments, in order to expand the chamber 502 for example the filtration capsule 504 within the body cavity, the jacket 508 is removed, and fluids are injected via the tube 514 into the internal volume of the filtration capsule, between the inner layers 524 with the hydrophobic coating. In some embodiments, the injected fluids cause the hydrophobic layers to repel and expand the filtration capsule. In some embodiments, a support layer within the wall of the chamber or in the internal volume comprises two compartments, at least one compartment which is shaped and sized to receive the stylet, or alternatively that includes an integrated stylet, and optionally at least one additional compartment which comprises the perforated tube 514.

Exemplary fluid extraction chamber with integrated channels

According to some exemplary embodiments, the fluid extraction chamber comprises a body, for example a filtration capsule with integrated channels within the internal volume of the body. In some embodiments, the integrated channels, for example integrated draining channels allow, for example, large aspect ratio while maintaining numerous drainage channels within the device, to optionally overcome local collapse, without the need to have an inner collection tube, for example tube 514 shown in figs. 5A and 5B.

According to some exemplary embodiments, a chamber having an integrated stylet and the integrated channels allows, for example, to ensure efficient fluid passage from all areas of the chamber, even in case of local occlusion or collapse.

Reference is now made to figs. 6A and 6B, depicting a fluid extraction chamber having integrated draining paths, according to some exemplary embodiments of the invention.

According to some exemplary embodiments, for example as shown in fig. 6A, a chamber 602 comprises a body, for example a filtering capsule 604 coupled to an outlet 606. In some embodiments, the chamber 602 comprises an integrated stylet 608, configured to expand when a jacket surrounding the chamber 602 is removed or dissolved. In some embodiments, a wall of the chamber comprises permeable media with integrated fluid delivery channels 610. According to some exemplary embodiments, for example as shown in fig. 6B, the chamber 610 comprises a filtration capsule 612, optionally shaped as a sac, coupled to an outlet 614. In some embodiments, an elastic support structure, for example a permeable skeleton mesh 616, found in the internal volume of the chamber enclosed by the wall of the chamber and provides mechanical support against applied vacuum, comprises a plurality of integrated channels 618 converging at the outlet 614. In some embodiments, the chamber comprises an integrated stylet, for example an expandable stylet, located within a wall of the chamber. Alternatively, in order to deploy and expand the chamber within the body cavity, an expandable stylet, for example an elastic stylet, is introduced into the wall of the chamber, optionally to a dedicated channel in the wall.

Exemplary seal

According to some exemplary embodiments, in order to extract fluids, vacuum is applied from outside the body on an internal volume of a fluid extraction chamber via an outlet exiting the body cavity through an opening in a wall of the body, for example an opening in the abdominal wall. In some embodiments, the vacuum generates negative pressure within the internal volume that applies suction forces on fluid within the body cavity, causing flow of the body cavity fluids into the internal volume of the chamber. In some embodiments, a seal in the abdominal wall opening is used in order to prevent leakage of vacuum and suction forces through the abdominal wall opening and/or through gaps between the outlet tube and tissue of the abdominal wall opening.

According to some exemplary embodiments, the body opening seal described herein is part of a system or part of a kit which comprises the fluid extraction chamber.

Reference is now made to fig. 7, depicting a body opening seal, according to some exemplary embodiments of the invention.

According to some exemplary embodiments, a seal, for example an expandable seal 702 is positioned in an opening formed in the abdominal cavity wall 704. In some embodiments, the seal comprises at least one tube, for example a flexible tube 706 crossing through the expandable seal 702. Optionally, tube 706 is made from silicon. In some embodiments, the expandable seal 702 is configured to expand, for example outwardly expand, within the opening in the abdominal wall and to seal any gaps between the tissue of the abdominal cavity wall surrounding the opening and the tube 706. In some embodiments, the expandable seal comprises a balloon. In some embodiments, inflation of the balloon expands the seal. Exemplary fluid removal chamber with gradual opening of pores

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, pores of a first membrane are configured to be open and to allow fluid flow into the internal volume of the filtration capsule at a pressure threshold which is different from a pressure threshold needed for opening of pores of a second membrane. In some embodiments, gradual opening of pores allows, for example, to maintain fluid removal over time, when some of the pores of the filtration capsule are clogged.

According to some exemplary embodiments, a chamber having a pressure dependent opening of pores is used for treating patients suffering from ascites with various degrees of fluid properties, such as liver cirrhosis, cancer, nephrotic syndrome or advanced heart failure. In some embodiments, this chamber allows, for example, facilitating chronic based application of ultrafiltration treatment, chronically and continually removing extracellular fluid from neighboring tissues, while also featuring other types of membrane behavior, allowing to rapidly drain ascites fluid, once acutely accumulated, without challenging the small pore membrane by infiltrating typically thicker ascites fluid. In some embodiments, the chamber allows to treat basal level of disease by removing ultrafiltrate while also responding to acute fluid accumulation in a given cavity.

Reference is now made to fig. 8A-8B, depicting a wall of a chamber which comprises two or more types of membrane portions, according to some exemplary embodiments of the invention.

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

Fig. 8C depicts a graph showing pressure dependent opening of the pores in each type of a membrane, according to some exemplary embodiments of the invention. Fig. 8C includes a graph showing a change in characteristic flow rate via the chamber (supply rate in ml/min divided by surface area), relative to pressure in the internal volume of the chamber, when pores of a first membrane and a second membrane are opened.

According to some exemplary embodiments, for example as shown in fig. 8C, in a first phase of the filtration process only pores of a first type of a membrane, for example type A, are opened, while pores of type B membrane are closed. In some embodiments, as pressure increases, the filtration rate or volume reaches a plateau, optionally due to clogging of pores of the type A membrane. In some embodiments, as the pressure inside the internal volume of the chamber increases, reaching a specific value, for example P-critical 811, pores of type B membrane are opened, leading to an increase in the characteristic filtration rate per surface area. In some embodiments, when pressure is higher than P-critical 811, pores of both membrane types are opened.

Exemplary multi lumen port tube

According to some exemplary embodiments, a port of a fluid extraction chamber is coupled to a tube, for example a flexible tube, having a first lumen towards the port and the internal volume of the fluid extraction chamber and at least one second lumen to the body cavity. In some embodiments, having a second lumen allows, for example to introduce at least one tool, for example a catheter into the abdominal cavity, through a single tube that passes through a single abdominal cavity opening to the implanted fluid extraction chamber.

Reference is now made to figs. 9A-9C depicting an access tube to a port of a fluid extraction chamber which includes at least one additional external channel, according to some exemplary embodiments of the invention.

According to some exemplary embodiments, a fluid extraction chamber 902 comprises a body, for example a filtration capsule 904 coupled to an outlet 906. In some embodiments, the outlet 906 is connected to an outlet tube 908. In some embodiments, for example as shown in fig. 9C, the outlet tube 908 extends out from the body of the patient through a single opening in the abdominal wall.

According to some exemplary embodiments, the outlet tube comprises at least one additional lumen 912 terminating outside the outlet 906. In some embodiments, the at least one additional lumen allows using the same opening in the abdominal wall for both access to the outlet of the fluid extraction chamber, and to introduce at least one tool, for example a catheter into the abdominal cavity 916.

According to some exemplary embodiments, the multi lumen outlet tube is used during dialysis and/or ultrafiltration for removal of ascites and for maintenance of the body cavity or the fluid extraction device, or for any other device implanted in the abdominal cavity. In some embodiments, the multi lumen tube is used to introduce a catheter, for example a drainage catheter, for example to drain fluids accumulating in the body cavity, for example the abdominal cavity, for example in clinical situations when fluids are accumulated too fast to allow efficient removal via the chamber 902. Exemplary toxin removal

According to some exemplary embodiments, during filtration and /or due to a clinical state of a patient, a level of toxins in the body cavity fluids is increased. In some embodiments, beads which are configured to bind the toxins are inserted into the internal volume of the fluid extraction chamber. In some embodiments, after a predetermined time period, the beads are removed from the fluid extraction chamber, and are optionally replaced with new beads. In some embodiments, the beads are used to remove protein bound uremic toxins (PBUT), such as kynurenine, kynurenic acid, indoxyl sulfate and hippuric acid; other proinflammatory hormones such as TNF-alpha, Interluekin-6 (IL6); and fibrosis mediators such as Recombinant MMP -2 proteins TIMP metallopeptidase inhibitor 1 (TIMP1) from body cavity fluids.

According to some exemplary embodiments, the beads are coupled to a string, that is introduced through the outlet into the internal lumen of the chamber. In some embodiments, in order to remove the beads, the string is pulled out form the fluid extraction chamber. Alternatively, suction is applied in order to remove the beads.

According to some exemplary embodiments, for example as shown in fig. 10 A, the fluid extraction chamber 1002 comprises an outlet 1004 having at least two separate flow paths into the internal volume 1006 of the chamber 1002. In some embodiments, the outlet is coupled to a multi lumen tube In some embodiments, at least one flow path 1010 is used for inserting a tube, for example a perforated tube 1008 into the internal volume 1006, for example to allow expansion of the chamber 1002 and/or for applying vacuum. In some embodiments, the flow path 1010 terminates with the tube. In some embodiments, at least one second flow path 1012 is used for delivery of beads 1014 into the internal volume 1006. In some embodiments, the beads are bound to a string. Alternatively, the beads flow freely inside the internal volume 1006.

According to some exemplary embodiments, for example as shown in fig. 10B, the chamber 1020 comprises a single lumen outlet 1022, optionally coupled to a single lumen tube 1024. In some embodiments, the chamber 1020 comprises a valve 1026, for example a leaflet valve, in the outlet 1022, for example between the outlet 1022 and the internal volume 1006. Alternatively, the valve is within the tube 1024 coupled to the outlet 1022. In some embodiments, the valve is used to control the flow of beads 1028 through a single lumen of the outlet 1022, used also for fluid removal. In some embodiments, the valve 1026 comprises a filter that allows suction of fluids out from the internal volume 1006 without passage of beads 1028 into the outlet 1022. In some embodiments, in order to remove the beads 1028, the valve 1026 comprising the filter is actively opened, for example by insertion of a tube from outside the body through the outlet 1022 into the internal volume, leading to opening of the valve. Exemplary structure of fluid extraction chamber

According to some exemplary embodiments, a fluid extraction chamber comprises an expanded body, configured to be entered into a subject body cavity, for example into an abdominal cavity, in a collapsed state, for example a folded state, and to expand, for example unfold, within the body cavity. In some embodiments, the body comprises an inner support structure, configured to expand the body within the body cavity and/or to maintain the body in an expanded state during fluid extraction.

According to some exemplary embodiments, the inner support structure comprises a scaffold, optionally formed from one or more flexible stylets, optionally flexible stylets. In some embodiments, the one or more stylets are at least partly coupled to the body or to a port of the body through which fluid is drained from the body inner lumen, during the insertion of the chamber into the subject body cavity. In some embodiments, during deployment of the body within the body cavity, the one or more flexible stylets are pushed into the body inner lumen from the outside of the chamber and optionally via the port, causing the body to stretch by pressing an inner surface of the body.

Alternatively, the one or more stylets are already fully inserted into the inner lumen when the chamber is introduced into the body cavity, and are optionally folded with the chamber body, in a collapsed state. In some embodiments, during deployment within the body cavity, the one or more stylets self-expand and press the inner surface of the body. In some embodiments, expansion of the one or more stylets comprise laterally expansion of the stylets. Alternatively or additionally, an elongated deployment tool, for example an expanding tool, coupled to the chamber body or to the inner scaffold is used to expand the chamber body and/or scaffold by applying forced on the deployment tool from outside the subject body. In some embodiments, for example when using a deployment tool, the scaffold, for example the one or more stylets, is optional.

Reference is now made to figs. IOC and 10D showing a structure of a fluid extraction chamber body, according to some exemplary embodiments of the invention.

According to some exemplary embodiments, a fluid extraction chamber 1042 comprises a body 1042 having a wall defining an inner lumen 1044. In some embodiments, the body 1042 is an expandable body, configured to move between a collapsed state, for example a folded optionally rolled state, during the insertion of the chamber 1040 into a subject body cavity, to an expanded state, for example an unfolded state optionally unrolled, when deploying the fluid extraction chamber in the subject body cavity. According to some exemplary embodiments, the chamber 1040 further comprises an inner support structure, for example a scaffold 1052, within the inner lumen 1044. In some embodiments, the body 1042 comprises an outlet 1046, for example a port, through which fluids in the inner lumen can exit the chamber via a draining tube to a reservoir and/or outside the subject body. In some embodiments, the scaffold 1052 is configured to expand the body 1042 by applying force from the inner lumen 1044 outwardly on an inner surface of the wall 1048. In some embodiments, following deployment of the chamber 1040 within the body cavity and/or during active fluid extraction, the scaffold is mechanically coupled to the port 1046 and/or to the body wall.

According to some exemplary embodiments, the wall of the body 1042 is formed from at least one outer membrane layer 1048 having pores that allow fluid from the body cavity to penetrate into the inner lumen 1044 of the chamber 1040, and at least one porous inner layer 1050, for example a mesh layer or any other porous layer.

According to some exemplary embodiments, for example as shown in fig. 10D, the at least one inner layer 1050 is used to adhere together two portions of at least one outer membrane layer 1048, for example in a periphery of the body 1042. In some embodiments, the two portions of the at least one outer membrane layer 1048 or at least two separate outer membrane layers, are welded, for example along a double weld seam line, to at least one inner layer 1050 positioned therebetween. In some embodiments, the seam line between the two membrane layers or between two portions of a single layer, is formed and located along a 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 materials. In some embodiments, the at least one outer membrane layer 1048 is formed from at least one of, Polyethersulfone (PES), polyvinylidene difluoride (PVDF), polytetrafluoroethylene (PTFE), Nylon, Cellulose, Collagen or any derivative thereof or any other similar material.

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

Exemplary fluid extraction chamber with an introducible scaffold

According to some exemplary embodiments, the fluid extraction chamber comprises an inner scaffold, optionally an expandable or an unfoldable scaffold. In some embodiments, the inner scaffold is preformed to acquire a specific form when expanded within a body of the fluid extraction chamber. Optionally, the inner scaffold is formed from a shape memory alloy, for example Nickel-Titanium Alloys (Nitinol), Copper-Based Alloys, Iron-Manganese-Silicon Alloys, Iron-Platinum Alloys, and/or Gold-Cadmium Alloys.

A potential advantage of having a pre-shaped inner scaffold may be that it allows to control a force applied on an inner surface of the fluid extraction chamber body after expansion, and/or shape of the fluid extraction chamber body following deployment and/or strength of the body against external forces applied on the fluid extraction chamber by organs within a body cavity optionally during movement of the subject.

Reference is now made to figs. 11A-1 ID, depicting a fluid extraction chamber having an inner introducible support structure, for example a scaffold, according to some exemplary embodiments of the invention.

According to some exemplary embodiments, a 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 cavity and to expand within the body cavity using an inner scaffold, for example a support structure. In some embodiments, a wall of the body comprises a porous membrane having pores in a size that allows, for example for fluid to enter from the body cavity into the inner lumen 1106, optionally as described in figs. 1 and 2A. In some embodiments, the body 1104 comprises at least one opening, for example an outlet opening 1108, that is configured to allow the exit of the fluid from the inner lumen 1106 via a draining tube outside the subject body, or alternatively exit of the fluid from the inner lumen 1106 via a draining tube into an organ of the subject body. It should be understood that in some embodiments, the term outlet opening of a fluid extraction chamber means a port or a connector in an opening of the chamber body through which fluid and/or other elements can pass into and out from the chamber inner lumen.

According to some exemplary embodiments, the body 1104 is introduced into the subject body cavity in a collapsed state, for example as shown in fig. 11A, while an inner scaffold 1110 is partially entered into the inner lumen 1106, optionally, through the at least one outlet opening 1108 or through a passage or channel in the outlet opening 1106. In some embodiments, advancing the scaffold 1110 into the body lumen 1106 when the body 1106 of the chamber in within the subject body cavity, expands the body 1104 into an expanded state, for example as shown in fig. 11B. In some embodiments, a distal end 1109 of the stylet 1110 is coupled to the port 1108, while a proximal end of the scaffold, is configured to move into the inner lumen 1106, for example to expand the body 1104. According to some exemplary embodiments, the scaffold 1110 comprises at least one elongated stylet, optionally formed from a shape memory alloy. In some embodiments, when the stylet is advanced into the inner lumen 1106, the stylet pushes an inner surface of the body 1104 outwardly, causing the body 1104 to expand. In some embodiments, the stylet is preformed, for example pretreated to acquire a specific target shape when advanced into the inner lumen 1106. In some embodiments, the stylet is formed from at least one, or two or more wires of Nitinol, metal and/or polymer material.

According to some exemplary embodiments, for example as shown in fig. 11C, which is an enlarged view of the outlet region, the outlet 1108 optionally comprises a recess 1112 in an inner surface of the outlet 1108, or alternatively in an inner surface of a connector 1114 positioned within the outlet 1108. Optionally, the connector 1114 is shaped and sized to allow connection of a draining tube to the body 1104 of the extraction chamber 1102. In some embodiments, the inner surface faces the stylet that is introduced into the inner lumen 1106.

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

According to some exemplary embodiments, movement of the scaffold 1110, for example turning of the scaffold, releases the proximal portion from the outlet opening, for example from the connector, to optionally allow retraction of the scaffold 1110 from the inner lumen 1106, for example to allow removal of the chamber 1102 from a body cavity of the subject.

Exemplary fluid extraction chamber with an integrated scaffold

Reference is now made to figs. 12A and 12B, depicting a fluid extraction chamber having an integrated scaffold, according to some exemplary embodiments of the invention.

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

According to some exemplary embodiments, for example as described with respect to scaffold 1110, the scaffold 1210 is optionally formed from a shape memory alloy, and comprises at least one elongated stylet. Optionally, the scaffold 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, a cross-section of the stylet is circular, round, oval, elliptical, polygonal, or shaped as a rectangle. In some embodiments, the stylet is formed from at least one, or two or more wires of Nitinol, metal and/or polymer material.

According to some exemplary embodiments, the scaffold 1210 is flexible and optionally elastic. In some embodiments, the scaffold 1210 is configured to fold into two partially oval portions that partially overlap each other, when the chamber is in a compressed state, for example as shown in fig. 12A. Optionally, the scaffold 1210 is configured to fold to form a helical shape having at least two partially overlapping portion, when the chamber is in a collapsed state, optionally during introduction of the chamber 1202 into a body cavity, for example as shown in fig, 12A. In some embodiments, unfolding of the scaffold to acquire a round shape, pushed the inner surface of the body 1204 and expands the body 1204 and the chamber 1202, for example as shown in fig. 12B. Optionally, the scaffold 1210 is configured to fold within the body cavity, optionally to allow removal of the chamber 1202 form the subject body cavity.

Reference is now made to figs. 13A and 13B, depicting an inner scaffold formed from a least two elongated stylets, at least one outer stylet and at least one inner stylet, according to some exemplary embodiments of the invention.

According to some exemplary embodiments, a fluid extraction chamber 1302 comprises a body 1304 having an inner lumen 1306, and an outlet opening 1308 to the inner lumen 1306. Optionally, for example as shown in fig. 13 A, the body 1304 comprises an inner sac within the inner lumen 1306. In some embodiments, the chamber 1302 comprises at least one inner scaffold formed from at least one outer stylet 1310 and at least one inner stylet 1312. In some embodiments, each stylet has a different elasticity level, for example to resist different external forces applied on the body 1304 from the outside. In some embodiments, the at least one inner scaffold comprising the outer stylet 1310 and the inner stylet 1312 are positioned within the inner lumen 1306 of the body 1304, and optionally within the sac.

Optionally, the at least one inner scaffold comprising the outer stylet 1310 and the inner stylet 1312 is integrated with the body 1304, for example mechanically coupled to an inner surface of the sac, to the body 1304 or to the outlet 1308, for example to a port. Alternatively or additionally, the at least one inner scaffold 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 an expanded state, a diameter of the at least one inner scaffold 1312 is smaller than a diameter of the at least one outer scaffold 1310. In some embodiments, the outer stylet 1310 and the inner stylet 1312 are arranged and/or function in a tandem configuration, for example against external forces applied on the body 1304. In some embodiments, the inner and/or the outer stylet is formed from at least one, or two or more wires of Nitinol, metal and/or polymer material.

According to some exemplary embodiments, for example as shown in fig. 13B, having an inner scaffold formed from at least one outer stylet 1310 and at least one inner stylet 1312 optionally allows gradual collapse of the body 1304 by pressure applied on the body 1304 by an organ 1320 or tissue within the body cavity. In some embodiments, the organ 1320 pushes inwardly an outer membrane of the body 304, while inwardly bending the outer stylet 1310 into the inner stylet 1312. In some embodiments, the inner stylet 1312 is less flexible and/or more bending resistant compared to the outer stylet 1310, and resists the pressure applied by the organ 1320. In some embodiments, the inner stylet 1312 allows to maintain a functional volume of the inner lumen 1306 that is sufficient for expansion and compression of the body when pressure is applied by a pump of the inner volume 1306, for removal of fluids from the body cavity.

Optionally, the outer stylet 1310 and the inner stylet 1312 are similar to the stylet 1210 described in figs. 12A and 12B.

Exemplary expansion of a fluid extraction chamber

According to some exemplary embodiments, a fluid extraction chamber comprises at least one support structure, for example an inner scaffold, positioned within an inner lumen of the fluid extraction chamber body. In some embodiments, the at least one inner scaffold is an expandable scaffold, configured to move between a collapsed state to an expanded state, within a body cavity of a subject. Optionally, the at least one scaffold is a reversibly expandable scaffold, configured to move between an expanded state within the subject body cavity onto a collapsed state, for example to allow removal of the fluid extraction chamber from the subject body cavity. In some embodiments, expansion of the scaffold expands the fluid extraction chamber.

According to some exemplary embodiments, the scaffold is a self-expandable scaffold. Alternatively, the scaffold expands in response to a force applied on the scaffold and/or on the fluid extraction chamber body from outside the subject body. Optionally, the applied force changes a configuration and/or shape of the scaffold. Alternatively or additionally, the applied force changes a configuration and/or shape of the fluid extraction chamber body. In some embodiments, applying the force from outside the subject body allows to, for example, to control expansion timing and/or shape of the expanded fluid extraction chamber. In some embodiments, the applied external force on the fluid extraction chamber body is optionally used to push organs in the subject body cavity to clear a volume with the body cavity that is sufficient for expansion of the fluid extraction chamber.

Reference is now made to figs. 14A-14C depicting expansion of a fluid extraction chamber using at least one an external rod, according to some exemplary embodiments of the invention.

According to some exemplary embodiments, a 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 with at least one tube 1407. In some embodiments, the chamber 1402 comprises at least one inner scaffold 1410 which is configured to move between a collapsed state, folded for example into two loops, as shown in fig. 14A, optionally when inserting the chamber into a subject body cavity, to an expanded state, where the inner scaffold 1410 laterally expands to form a single loop, for example when deploying the chamber 1402 within the subject body cavity.

Optionally, for example as shown in fig. 14 A, when introducing the fluid extraction chamber 1402 into the subject body cavity, the body 1404 is placed within an outer jacket. In some embodiments, the jacket is a dissolvable jacket configured to dissolve when exposed to fluids within the subject body cavity. Alternatively, the jacket is a removable jacket, configured to be retracted from the subject body cavity after the insertion of the chamber 1402 into the subject body cavity. In some embodiments, the jacket, optionally formed from at least one sheet of material, is configured to reduce friction between the outer surface of the chamber body 1404 and tissues of the subject body during the insertion of the chamber 1402 into the subject body cavity. Optionally, the jacket is configured to be retracted out form the subject body. Optionally, the jacket is a tearable jacket.

According to some exemplary embodiments, after the positioning of the chamber 1402 within the subject body cavity, at least one elongated deployment tool, for example rod 1414 is introduced through the outlet opening 1408 into the inner lumen 1406 of the body 1404 and contacts the scaffold 1410. In some embodiments, a proximal end of the rod 1414 is located outside the subject body, for example to allow manipulation of the rod and a distal end of the rod from outside the subject body. Optionally, the rod 1414 is introduced into the lumen 1406 after the removal of the outer jacket. In some embodiments, for example as shown in fig. 14B, the rod 1414, for example a distal end 1416, applies force on the scaffold 1410, optionally pushes the scaffold 1410, which is sufficient to move the scaffold from a collapsed state to an expanded state, causing the body 1404 to expand.

Alternatively, the chamber 1402 is introduced into the subject body cavity while the rod 1414, for example a distal end 1416 of the rod 1414 is already mechanically coupled to the scaffold 1410, and a proximal end of the rod 1414 is located outside the subject body. In some embodiments, after expansion of the scaffold 1410, the rod 1414 is retracted from the expanded body 1404, via the outlet 1408.

According to some exemplary embodiments, the rod 1414 is rigid in an axial direction in a long axis of the rod 1414, and is optionally flexible in a lateral direction, in an angle to the long axis, for example to allow forward advancement and/or retraction of the rod 1414 within a tube connected to the outlet 1408 while optionally allowing the rod 1414 to bend within the tube.

Reference is now made to figs. 14D-14G, depicting decoupling of a deployment rod from a scaffold, according to some exemplary embodiments of the invention.

According to some exemplary embodiments, for example as shown in figs. 14D and 14E, a rod 1420 is a hollow rod having at least one wire 1422 passing within a lumen 1424 of the rod 1420 between a proximal end of the rod located outside the subject body, and a distal end 1426 of the rod 1420 mechanically coupled to the scaffold 1410. In some embodiments, pulling of the at least one wire 1422 decouples the distal end 1426 from the scaffold 1410, optionally tears the distal end 1426 form the scaffold 1410, for example as shown in fig. 14E.

Alternatively, for example as shown in figs. 14F and 14G, a rod 1430 comprises a grasping portion 1432, for example a distal grasping portion that is configured to grasp and be released from the scaffold 1410 in response to manipulation of a proximal end of the rod 1430, for example a proximal portion of the rod, located outside the subject body cavity. Optionally, the rod 1430 is a grasper tool or is a rod of a grasper tool.

According to some exemplary embodiments, a fluid extraction chamber is expanded using at least one external expanding tool, for example a spreader, which is controlled from outside the body cavity and is used to apply force of the chamber body that is sufficient to at least partly expand the chamber. In some embodiments, the spreader expands the chamber body to a degree that allows expansion of an inner scaffold, for example to stabilize the chamber body in an expanded state within a body cavity.

Reference is now made to figs. 15A-15C, depicting expansion of a fluid extraction chamber using a expanding tool, for example a spreader, according to some exemplary embodiments of the invention.

According to some exemplary embodiments, a fluid extraction chamber 1502 comprises a body 1504, for example an expandable body 1504, having an inner lumen 1506 and at least two outlet openings 1508 and 1512 to the inner lumen 1506. In some embodiments, the chamber 1502 comprises at least one inner scaffold 1510 positioned within the inner lumen 1506. In some embodiments, the at least one inner scaffold 1510 is mechanically coupled to an expanding tool, for example a spreader comprising at least two elongated rods 1508 and 1512 each penetrates into the inner lumen 1506 via a different outlet opening of openings 1508 and 1512, for example as shown in fig. 15A. Optionally, the chamber 1502 is placed within a jacket 1503 when introduced into a body cavity of the subject.

According to some exemplary embodiments, when introducing the chamber 1502 into a body cavity, organs and/or tissue within the body cavity apply force on the outer surface of the body 1504, preventing expansion of the inner scaffold and/or of the body 1504. In some embodiments, for example as shown in fig. 15B, in order to allow expansion of the scaffold 1510 and/or of the body 1504, each of the at least two rods 1514 and 1516 pushes the inner surface of the body 1504 or the scaffold 1510 in an opposite direction, causing the body 1504 to expand. In some embodiments, a distal end of each of the rods moves, optionally at an opposite direction, relative to each other, for example to expand the body 1504. In some embodiments, the force applied by each of the rods 1514 and 1516 on the wall of the body 1504, pushes the tissue and/or organ pressing from the outside on the body 1504 to an extent that allows expansion of the inner scaffold 1510 for stabilizing the body 1504 in an expanded state.

According to some exemplary embodiments, the body 1504 in an expanded state has a trapezoidal shape. According to some exemplary embodiments, for example as shown in fig. 15C, following expansion of the body 1504 and/or of the inner scaffold 1510, the spreader comprising the at least two rods is retracted, and the outlets 1508 and 1512 are connected to at least one pump 1520 via tubes 1522 and 1524. Optionally, the tubes 1522 and 1524 are coupled to the pump via a connector, for example a Y-connector 1526.

Reference is now made to figs. 16A-16C, depicting expansion of a fluid extraction chamber using an expanding tool comprises at least two external rods, according to some exemplary embodiments of the invention.

According to some exemplary embodiments, for example as shown in figs. 16A and 16B, a chamber 1602 comprises a body 1604 having an inner lumen 1606 and at least one outlet opening 1608. In some embodiments, the chamber 1602 comprises at least one inner scaffold 1610, optionally a stylet. In some embodiments, an external surface of the body 1604 is mechanically coupled to a spreader, for example to at least two rods of a spreader, for example rods 1614 and 1616. In some embodiments, each of the rods 1614 and 1616 is coupled to the external surface of the body 1604 by at least one fastener, for example loops 1618 and 1620. According to some exemplary embodiments, during insertion of the chamber 1602 into a subject body cavity, the rods 1614 and 1616 are optionally substantially parallel to each other. In some embodiments, after the chamber 1602 is positioned within the subject body cavity, a proximal portion of each of the rods for example portions 1629 and 1629, optionally located outside the subject body, is moved towards a proximal portion of a different rod, for example as shown in fig. 16B, optionally causing the distal ends 1630 and 1632 of the rods to move further away from each other. Optionally, the proximal portions 1627 and 1629 are moved until they cross each other, as shown for example in fig. 16B. In some embodiments, movement of the proximal portions of rods 1514 and 1516 shown in figs. 15A and 15B is similar to the movement of proximal portions 1627 and 1629.

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

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. Reference is now made to figs. 17A-17C depicting expansion of a fluid extraction chamber using an external expanding tray, according to some exemplary embodiments of the invention.

According to some exemplary embodiments, a fluid extraction chamber 1702 represented in the figures with dashed lines, comprises a body 1704, for example an expandable body, having an inner lumen 1706, and at least one inner scaffold 1710 within the inner lumen 1706. Additionally, the body 1704 comprises at least one outlet opening 1708 to said inner lumen 1706, configured to allow extraction of fluid from the inner lumen 1706 out form the chamber 1702, optionally via at least one tube coupled to the outlet opening 1708.

According to some exemplary embodiments, during insertion of the chamber 1702 into a body cavity in a subject body, the chamber 1702 is coupled to an external expanding tray 1730, represented in the figs. 17A-17C in continuous lines and circles.

According to some exemplary embodiments, the expanding tray 1730 comprises at least one elongated plate 1732 and at least two movable arms 1734 and 1736, each is optionally coupled to the plate 1732 by at least one hinge, for example 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 a long axis of the plate 1732 and/or overlap, optionally entirely overlap, with the plate 1732, and a second state in which the arms 1734 and 1736 extend sideways relative to the plate 1732.

According to some exemplary embodiments, the expanding tray 1702 comprises at least one elongated actuating bar 1742, functionally coupled to the arms 1734 and 1736 and/or to the hinges 1738 and 1740. In some embodiments, movement of the bar 1742, for example axial movement, moves the arms between the first state and the second state.

According to some exemplary embodiments, the chamber 1702 is coupled, optionally reversibly coupled, to the arms 1734 and 1736. Optionally, the arms 1734 and 1736 are coupled to opposite edges of the body 1704.

According to some exemplary embodiments, for example as shown in fig. 17A, , during insertion of chamber 1702 into the subject body, the chamber 1702 is coupled to the tray 1730, and is kept in a collapsed state by the tray 1730. In some embodiments, the arms 1734 and 1736 are substantially aligned with the plate 1732, in the first state, keeping the chamber 1702 in the collapsed state.

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

Optionally for example as shown in fig. 17C, further manipulation, for example axial and/or rotation of the bar 1742, decouples the expanding tray 1730 form the chamber 1702, allowing for example to retract expanding tray 1730 from the subject body.

Reference is now made to figs. 17D and 17E, depicting movement of arms of the expanding tray, according to some exemplary embodiments of the invention.

According to some exemplary embodiments, each of the arms of an expanding tray, for example arm 1750 is functionally coupled to a body 1750 of a fluid extraction chamber via at least one loop of the body 1750, for example loop 1754. Optionally, the arm 1750 is reversibly coupled to the loop by a wire 1756. In some embodiments, the wire 1756 is tied to the loop by a knot that can be opened, for example when pulling the wire, optionally to decouple the arm 1750 from the loop 1754 and the chamber body 1752.

According to some exemplary embodiments, the arm 1750 comprises a cog wheel 1760 at a proximal end of the arm 1750. In some embodiments, teeth of the cog wheel 1760 match recesses 1762 between teeth at a distal end of an elongated actuating bar is functionally coupled to an elongated actuating bar 1764 such that axial movement of the bar 1764 is translated to rotation movement of the cogwheel 1760 and movement of the arm 1750. In some embodiments, for example as shown in fig. 17E, retraction of the bar 1764, extends the arm 1750 sideways, causing the body 1754 to expand.

Exemplary chamber deployment

According to some exemplary embodiments, a fluid extraction device is inserted into a body cavity, for example into an 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. According to some exemplary embodiments, the fluid extraction chamber is introduced into the body cavity in a collapsed state, for example in a folded state, optionally while an inner scaffold is at least partly coupled to the chamber body. In some embodiments, when introducing the chamber into the body cavity, one or more organs or tissues in the body cavity needs to be moved in order to have room for proper deployment of the chamber.

In some embodiments, in order to assist with the expansion of the chamber, for example unfolding of the chamber, within the body cavity, an expanding tool is used. In some embodiments, the expanding tool is coupled to the chamber and/or to the inner scaffold, and extends out from the body cavity. In some embodiments, manipulation of the tool from outside the body cavity, for example from outside the subject body, applies force on the chamber body and/or inner scaffold that is sufficient for expansion of the chamber within the body cavity. In some cases, use of combination of manipulation from outside the body and from within the body are utilized, for instance, insertion of one or more additional expanding guidewire into the inner lumen of the chamber body.

Reference is now made to fig. 18, depicting a process for deployment of a fluid extraction chamber within a body cavity using an expanding tool, according to some exemplary embodiments of the invention.

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

According to some exemplary embodiments, a fluid extraction chamber is introduced via the formed opening into the body cavity, at block 1804. In some embodiments, the chamber, optionally an elongated chamber, is introduced in a collapsed state, for example in a folded state where the chamber body is folded or rolled, into the body cavity, within an outer sleeve, for example a jacket, wrapping the chamber and optionally maintaining the chamber in a collapsed state. In some embodiments, the chamber comprises an inner expandable scaffold at least partly coupled to the chamber body or to an outlet, for example a port of the chamber body, during the insertion into the body cavity. In some embodiments, the fluid extraction chamber is coupled to at least one expanding tool, for example 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 body.

According to some exemplary embodiments, the outer sleeve is removed from the chamber at block 1806. In some embodiments, the outer sleeve is removed by from the body cavity via the formed opening. In some embodiments, the outer sleeve is removed, for example by pulling wires coupled to the outer sleeve, from outside the subject body.

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

Alternatively and optionally, for example when the entire scaffold is already within the chamber during the chamber insertion into the body cavity, at block 1804, the scaffold selfexpands, optionally laterally, or unfolds. In some embodiments, the scaffold self-expands or selfunfolds, after removal of the outer sleeve at block 1806.

According to some exemplary embodiments, an expanding tool is moved at block 1810. In some embodiments, the expanding tool comprising at least one rod, for example as shown in figs. 14A-14G, or at least two rods for example as shown in figs, at least two rods for example as shown in figs. 15A-15C and in figs. 16A-16C, or an expanding tray shown in figs. 17A-17E, is moved from outside the body cavity, for example from outside the subject body.

According to some exemplary embodiments, moving of the expanding tool comprises axial movement and/or rotation. In some embodiments, the movement of the expanding tool expands, for example unfolds the chamber body. Optionally, expanding of the chamber body allows the inner scaffold to expand and to maintain the chamber in an expanded state.

In some embodiments, when using an expanding tool, for example an expander, the inner scaffold is optional, and the device does not include an inner scaffold. In these embodiments, after expansion the chamber is is rigid enough to maintain an expanded state and/or to resist external forces without an inner scaffold.

According to some exemplary embodiments, the expanding tool is removed from the body cavity, at block 1812. In some embodiments, the expanding tool is decoupled from the chamber and removed by pulling one or more wires from outside the body cavity. In some embodiments, the expanding tool is decoupled from the chamber by a applying a force on a tearing region between the tool and the chamber, and/or by releasing at least one grasping head of the tool from the chamber, for example as shown in figs. 14D-14G.

According to some exemplary embodiments, the chamber is coupled to a tube and/or to a pump at block 1814. In some embodiments, the chamber is coupled to the tube and/or to a pump after expansion of the chamber inside the body cavity. In some embodiments, at least one outlet or at least one port of the chamber is coupled to at least one tube, for example a draining tube. As used herein with reference to quantity or value, the term “about” means “within ± 10 % of’.

The terms “comprises”, “comprising”, “includes”, “including”, “has”, “having” and their conjugates mean “including but not limited to”.

The term “consisting of’ means “including and limited to”.

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 alter the basic and novel characteristics of the claimed composition, method or structure.

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

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

Whenever a numerical range is indicated herein (for example “10-15”, “10 to 15”, or any pair of numbers linked by these another such range indication), it is meant to include any number (fractional or integral) within the indicated range limits, including the range limits, unless the context clearly dictates otherwise. The phrases “range/ranging/ranges between” a first indicate number and a second indicate number and “range/ranging/ranges from” a first indicate number “to”, “up to”, “until” or “through” (or another such range-indicating term) a second indicate number are used herein interchangeably and are meant to include the first and second indicated numbers and all the fractional and integral numbers therebetween.

Unless otherwise indicated, numbers used herein and any number ranges based thereon are approximations within the accuracy of reasonable measurement and rounding errors as understood by persons skilled in the art.

As used herein, the term “treating” includes abrogating, substantially inhibiting, slowing or reversing the progression of a condition, substantially ameliorating clinical or aesthetical symptoms of a condition or substantially preventing the appearance of clinical or aesthetical symptoms of a condition.

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

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

It is the intent of the applicant(s) that all publications, patents and patent applications referred to in this specification are to be incorporated in their entirety by reference into the specification, as if each individual publication, patent or patent application was specifically and individually noted when referenced that it is to be incorporated herein by reference. In addition, citation or identification of any reference in this application shall not be construed as an admission that such reference is available as prior art to the present invention. To the extent that section headings are used, they should not be construed as necessarily limiting. In addition, any priority document(s) of this application is/are hereby incorporated herein by reference in its/their entirety.

Claims

WHAT IS CLAIMED IS:

1. A fluid extraction chamber suitable for implantation into a non-insufflated abdominal cavity, comprising: an elongated 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 said non-insufflated abdominal cavity, wherein said elongated expandable body comprises a fluid permeable wall defining an internal volume of the elongated expandable body; wherein in a collapsed state said elongated expandable body is shaped and sized to penetrate through an opening in an abdominal wall into a non-insufflated abdominal cavity, and wherein in an expanded state said elongated expandable body is thin and has a surface area that is at least 5 times larger than a surface area of said elongated expandable body in said collapsed state; an outlet coupled to said elongated expandable body, having at least one opening to said internal volume.

2. A chamber according to claim 1, wherein said chamber is suitable for implantation into said non-insufflated abdominal cavity under local anesthesia.

3. A chamber according to any one of claims 1 or 2, wherein a maximal width of said elongated expandable body in said expanded state is at least 3 times larger than a maximal width of said elongated expandable body in said collapsed state.

4. A chamber according to any one of the previous claims, comprising an elastic porous skeleton in said internal volume contacting an inner surface of said fluid permeable wall, wherein said elastic porous skeleton is configured to apply force against said inner surface, to collapse when said elongated body is in a collapsed state, and to expand when said elongated expandable body is in an expanded state when deployed in said non-insufflated abdominal cavity.

5. A chamber according to claim 4, wherein said elastic porous skeleton comprises at least one layer of an elastic semi-rigid mesh.

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

7. A chamber according to any one of claims 4 to 6, wherein pores in said elastic porous skeleton have a similar size and/or shape.

8. A chamber according to any one of claims 4 to 6, wherein pores in said elastic porous skeleton have a varying size and/or shape.

9. A chamber according to any one of claims 4 to 8, wherein said elastic porous skeleton comprises an auxetic structure and/or an auxetic material, configured to allow expansion of the elastic porous skeleton when the elastic porous skeleton is stretched.

10. A chamber according to any one of claims 4 to 9, wherein said elastic porous skeleton comprises integrated flow paths converging in said outlet, and wherein said integrated flow paths are shaped and sized to direct fluid entering said internal volume through different parts of the body towards said outlet.

11. A chamber according to any one of the previous claims, wherein in said expanded state said elongated expandable body is substantially flat and thin, having a maximal thickness smaller than 2 mm along at least 90% of a width of the body.

12. A chamber according to any one of the previous claims, wherein a ratio between a width and a length of said body in an expanded state is at least 1: 1.4.

13. A chamber according to any one of the previous claims, wherein a ratio between a length and a width of said elongated expandable body, in said collapsed state is at least 3: 1.

14. A chamber according to any one of the previous claims, wherein a maximal width of said elongated expandable body in said collapsed state is smaller than 10 mm.

15. A chamber according to any one of the previous claims, wherein in said expanded state, said body comprises a flexible stylet configured to outwardly push said fluid permeable wall.

16. A chamber according to claim 15, wherein said flexible stylet is integrated in said body.

17. A chamber according to claim 15, wherein said body comprises a circumferential channel configured to receive said flexible stylet, and wherein said flexible stylet is configured to be inserted through said outlet into said circumferential channel via said outlet, when said elongated expandable body is within said abdominal cavity.

18. A chamber according to claim 15, wherein said flexible stylet is configured to be inserted into said internal volume via said outlet.

19. A chamber according to any one of claims 15 to 18, wherein said flexible stylet is a bistate flexible stylet configured to move between a collapsed state and an expanded state.

20. A chamber according to any one of the previous claims, comprising a jacket placed around said elongated expandable body when said elongated expandable body is in said collapsed state, , wherein said jacket is configured to increase a rigidity of said elongated expandable body in said long axis direction.

21. A chamber according to claim 20, comprising one or more threads coupled to said jacket, configured to allow removal of said jacket form said elongated expandable body from outside said abdominal cavity.

22. A chamber according to any one of claims 20 or 21, wherein said jacket is formed from a dissolvable material, configured to dissolve when interacting with fluids in said abdominal cavity.

23. A chamber according to any one of the previous claims, wherein an inner surface of said fluid permeable wall facing said internal volume is coated with a degradable coating configured to seal said fluid permeable wall from passage of fluids through said fluid permeable wall.

24. A chamber according to claim 23, wherein said coating is a hydrophobic coating.

25. A chamber according to any one of the previous claims, comprising a perforated tube coupled to said outlet and extending into said internal volume.

26. A chamber according to any one of the previous claims, wherein said wall comprises at least one membrane layer having pores with a size in a range between 0.1 pm and 100 pm.

27. A chamber according to any one of the previous claims, wherein said fluid permeable wall is formed at least partly from at least two types of membranes, wherein pores of at least one membrane of said at least two membrane types are configured to open to allow passage of fluid under pressure levels that are different form pressure levels needed for opening of pores of at least one second membrane of said at least two membrane types.

28. A chamber according to any one of the previous claims, wherein said outlet comprises at least one flow path and a filter valve in said flow path, wherein said filter valve is configured to allow passage of fluids when said valve is closed, and to be opened when a tool is inserted through the outlet towards said internal volume.

29. A chamber according to any one of the previous claims, wherein said outlet comprises at least two separate flow paths into said internal volume, wherein at least one flow paths is used for extraction of fluids out from said internal volume, and wherein at leats one second flow path is used for introducing of toxin binding beads into said internal volume.

30. A fluid removal system, comprising: a chamber according to claim 1 ; an inflatable seal comprising at least one tube crossing said inflatable seal, wherein said tube is configured to be fluidically coupled to said outlet, and wherein said inflatable seal is configured to be positioned in said abdominal wall opening, and to seal gaps between said abdominal wall and said tube when inflated.

31. A fluid removal system, comprising: a chamber according to claim 1 ; a tube configured to cross said abdominal wall through said opening, wherein at least one end of said tube is coupled to said outlet, and wherein at least one second end of said tube is configured to be positioned outside the body of the patient, wherein said tube comprises at least two separate channels passing within said tube, wherein an end of at least one first channel of said at lets two separate channels is fluidically coupled to said outlet, and wherein an end of at least one second channel of said at least two separate channels is fluidically coupled to said noninsufflated abdominal cavity.

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

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

34. A fluid extraction chamber suitable for implantation into an abdominal cavity, comprising: an expandable body configured to move from a collapsed state to an expanded state, wherein said expandable body comprises a fluid permeable wall comprising at least one layer of a porous membrane, wherein said fluid permeable wall defines an internal volume of the body, wherein an inner layer of said fluid permeable wall is coated with a degradable coating; wherein in a collapsed state said expandable body is shaped and sized to penetrate through an opening in an abdominal wall into an abdominal cavity, and to expand within said abdominal cavity by injection of fluids into said internal volume, and wherein said degradable coating is configured to temporary seal pores of said membrane from passage of said injected fluids out from said internal volume through said fluid permeable wall.

35. A chamber according to claim 34, wherein said coating is a hydrophobic coating.

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

37. A chamber according to claim 36, wherein said elongated expandable body has a long axis and a short axis.

38. A chamber according to any one of claims 36 or 37, wherein said at least one elongated flexible stylet comprises a distal end mechanically coupled to said outlet and a proximal end configured to be introduced into said internal volume during deployment of the elongated expandable body, and to be mechanically coupled to said outlet.

39. A chamber according to claim 38, wherein said proximal end of said at least one elongated flexible stylet comprises an extension shaped and sized to match a recess in said outlet.

40. A chamber according to any one of claims 36 or 37, wherein said at least one elongated flexible stylet is integrated with said elongated expandable body and positioned within said internal volume during insertion of said elongated expandable body into said body cavity, wherein said at least one elongated flexible stylet is configured to be folded into two or more partly overlapping ring-shaped portions, when said elongated expandable body is in a collapsed state, and to expand into a single ring-shaped portion when said elongated expandable body is deployed in said body cavity .

41. A chamber according to any one of claims 36 to 40, wherein said at least one elongated flexible stylet comprises at least one outer stylet and at least one inner stylet, wherein when said elongated expandable body is in an expanded state, said at least one outer stylet pushes outwardly said fluid permeable wall and said at least one inner stylet is positioned between said at least one outer stylet and a center point of said internal volume.

42. A chamber according to any one of claims 36 to 41, comprising an elongated deployment tool having a distal end reversibly coupled to said at least one flexible elongated stylet and/or to said elongated expandable body, and a proximal end positioned outside said body cavity, wherein movement of said proximal end applies force on said at least one flexible elongated stylet and/or on said elongated expandable body which is sufficient to expand said elongated expandable body in said body cavity.

43. A chamber according to claim 42, wherein said elongated deployment tool comprises at least one elongated rod passing through said outlet into said internal volume, wherein said at least one elongated rod has a distal end reversibly coupled to said at least one flexible elongated stylet, and a proximal end located outside said body cavity, wherein axial advancement and/or rotation of said proximal end moves said at least one flexible elongated stylet from a collapsed state to an expanded state.

44. A chamber according to claim 42, wherein said outlet comprises at least two outlet openings, and wherein said elongated deployment tool comprises at least two elongated rods, each passes through a different outlet opening of said at least two outlet openings into said internal volume; wherein when said elongated expandable body is within said body cavity, movement of proximal ends of said at least two elongated rods relative to each other applies force on said fluid permeable wall which is sufficient to expand said elongated expandable body in said body cavity.

45. A chamber according to claim 42, wherein said elongated deployment tool comprises at least two elongated rods reversibly functionally coupled to said elongated expandable body at opposite sides of said elongated expandable body; wherein when said elongated expandable body is within said body cavity, movement of proximal ends of said at least two elongated rods relative to each other applies force on said elongated expandable body which is sufficient to expand said elongated expandable body in said body cavity.

46. A chamber according to claim 42, wherein said elongated deployment tool comprises an expanding tray, wherein said expanding tray comprises an elongated plate, at least two arms pivotally coupled to said tray at opposite sides of said tray, and at least one elongated actuating rod functionally coupled to said at least two arms, wherein said at least two arms are configured to be reversibly coupled to opposite sides of said elongated expandable body; wherein when said chamber is positioned within said body cavity, movement of a portion of said at least one elongated actuating rod located outside said body cavity moves said arms from a first state where said arms are substantially aligned with a long axis of said tray to a second state where said arms extend sideways from said plate while being reversibly coupled to said opposite sides of said elongated expandable body, thereby expanding said elongated expandable body within said body cavity.

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

48. A chamber according to claim 47 wherein said non-insufflated body cavity comprises a non-insufflated abdominal cavity, and wherein in said collapsed state said elongated expandable body is shaped and sized to penetrate through an opening in an abdominal wall into said noninsufflated abdominal cavity, and wherein in said expanded state said elongated expandable body is thin and has a surface area that is at least 5 times larger than a surface area of said elongated expandable body in said collapsed state.

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

50. A fluid extraction chamber suitable for implantation into a body cavity, comprising: an expandable body configured to move from a collapsed state to an expanded state when deployed in said body cavity, wherein said expandable body comprises a fluid permeable wall defining an internal volume of the expandable body; an outlet coupled to said expandable body, having at least one opening to said internal volume; wherein said 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 a circumference of said expandable body surrounding said internal volume.

51. A method for deploying an elongated fluid extraction chamber, comprising: locally anesthetizing a region in the abdominal wall of a subject selected as a target for forming an opening through the abdominal wall into a non-inflated abdominal cavity; forming said opening in said target region; introducing an elongated fluid extraction chamber having a fluid permeable wall defining an internal volume and an outlet of said internal volume, in a collapsed state into said noninflated abdominal cavity through said opening; expanding said elongated fluid extraction chamber within said non-inflated abdominal cavity to acquire a surface area that is at least 5 times larger than a surface area of said elongated fluid extraction chamber in said collapsed state.

52. A method according to claim 51, wherein said expanding comprises expanding said elongated fluid extraction chamber to have an external flat surface and a thickness smaller than 2 mm.

53. A method according to any one of claims 51 or 52, wherein said expanding comprises expanding said elongated fluid extraction chamber by introducing a stylet into said internal volume or into a circumferential channel in said fluid permeable wall.

54. A method according to any one of claims 51 to 53, wherein said fluid extraction chamber comprises an integrated stylet configured to move between a collapsed state and an expanded state, and wherein said expanding comprises expanding said fluid extraction chamber by moving said stylet into an expanded state.

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

56. A method according to any one of claims 51 to 55, comprising: applying following said expanding negative pressure intermittently on said internal volume through said outlet which is sufficient to draw fluid from said non-inflated abdominal cavity into said internal volume through said fluid permeable wall and out from said internal volume through said outlet.

57. A method according to any one of claims 51 to 56 comprising: diagnosing said subject with a chronic heart failure or with acute heart failure prior to said locally anesthetizing.

58. A method according to any one of claims 51 to 56, comprising: detecting ascites in said subject prior to said locally anesthetizing.

59. A method according to any one of claims 51 to 56, comprising: detecting Protein-Bound Uremic Toxins (PBUT) in said subject; introducing beads configured to bind said PBUT into said internal volume following said expanding.