Implantable Fluid Extraction System

Abstract

An implantable fluid extraction system having a shape and size convenient for implantation in a patient's body comprises: a fluid extraction cavity having a flat and thin shape, the fluid extraction cavity being connected to a drainage tube and comprising at least one external flat surface, wherein when a negative pressure is applied to the drainage tube, the at least one external flat surface is configured to adhere to a tissue surface, wherein the cavity utilizes the negative pressure applied by the flat surface on the attached tissue surface to extract fluid from the tissue.

Description

Technical Field

[0001] This application claims the benefit under 35 U.S.C. §119(e) of U.S. Provisional Application No. 62 / 505,931, filed May 14, 2017, the entire contents of which are incorporated herein by reference. Background Art

[0002] In some embodiments of the present invention, the present invention relates to a fluid extraction system, and particularly, but not exclusively, to an implantable extraction system.

[0003] As described in Flesner et al. (Blood Purif 1992; 10: 136-14), the nature of the fluid reaching the peritoneum is 25% lymph and 75% circulating and interstitial fluid. Summary of the invention

[0004] Some examples of some embodiments of the present invention are listed below. It should be noted that multiple features from one example can be combined with one or more features from other examples:

[0005] Example 1. An implantable fluid extraction system, the shape and size of the fluid extraction system being convenient for implantation into a patient, the fluid extraction system comprising:

[0006] a fluid extraction chamber connected to a drainage tube, wherein the chamber extracts fluid by applying a negative pressure on a tissue;

[0007] a control unit sized for subcutaneous implantation and connected to the drainage tube; wherein the control unit comprises:

[0008] a memory for storing at least one treatment plan or a portion of the at least one treatment plan;

[0009] a pump for applying negative pressure to the drainage pipe; and

[0010] a control circuit, wherein the control circuit activates the pump according to the treatment plan.

[0011] Example 2. The system according to Example 1, further comprising: at least one implanted physiological sensor connected to the control circuit; wherein the physiological sensor measures multiple values ​​of at least one physiological parameter of the patient.

[0012] Example 3. A system according to Example 2, wherein the at least one physiological parameter includes interstitial pressure, and / or blood pressure, and / or blood content, and / or heart rate of the patient.

[0013] Example 4. A system according to Example 2, wherein the physiological sensor measures the levels of creatinine, and / or albumin, and / or sodium, and / or potassium, and / or urea, and / or phosphate in the contents of the blood.

[0014] Example 5. The system of any one of Examples 2 to 4, wherein the at least one physiological parameter comprises an indication of congestion.

[0015] Example 6. The system of any one of Examples 2 to 5, wherein the plurality of measured values ​​of the at least one physiological parameter are stored in the memory.

[0016] Example 7. The system of Example 1, further comprising: at least one implanted extraction sensor connected to the control circuit, wherein the sensor measures multiple values ​​of at least one parameter related to the extracted fluid.

[0017] Example 8. The system of Example 7, wherein the at least one parameter comprises the flow of the extracted fluid, and / or the pressure of the extracted fluid, and / or the volume of the extracted fluid.

[0018] Example 9. The system of any of Examples 7 or 8, wherein the at least one parameter comprises levels of a plurality of biological and / or chemical species in the extracted fluid.

[0019] Example 10. A system according to Example 9, wherein the plurality of substances comprises creatinine, and / or albumin, and / or sodium, and / or potassium, and / or urea, and / or phosphate.

[0020] Example 11. The system of Example 7, wherein the extraction sensor measures congestion or an indication of congestion.

[0021] Example 12. The system of any one of Examples 7 to 11, wherein the plurality of measured values ​​are stored in the memory.

[0022] Example 13. The system of any of the preceding examples, further comprising: a catheter fluidly connected to the drainage tube, wherein the catheter has a tip connected to the urinary system.

[0023] Example 14. The system according to any of the preceding examples, further comprising: a reservoir fluidly connected to the drainage tube, wherein the shape and size of the reservoir are used to store the extracted fluid.

[0024] Example 15. A system according to any of the preceding examples, wherein the control unit further comprises: a communication circuit connected to the control circuit, wherein the communication circuit is connected to a handheld device and / or a remote computer via wireless communication.

[0025] Example 16. The system of Example 15, wherein the communication circuit sends a signal to the handheld device and / or the remote computer to generate a warning signal.

[0026] Example 17. The system of Example 15 or 16, wherein the communication circuit receives information from a handheld device and / or a remote computer, and wherein the information is stored in the memory.

[0027] Example 18. The system according to any of the preceding examples, further comprising: a battery connected to the control unit, wherein the battery provides power to the control circuit and the pump.

[0028] Example 19. The system of Example 18, wherein the battery is a rechargeable battery.

[0029] Example 20. The system of any of the preceding examples, wherein the fluid extraction cavity is flat and / or thin.

[0030] Example 21. A system according to any of the preceding examples, wherein the fluid extraction cavity is shaped and sized to directly contact the tissue of multiple organs located in the abdominal cavity.

[0031] Example 22. The system of any of the preceding examples, wherein the fluid extraction lumen is shaped and sized to directly contact columnar tissue.

[0032] Example 23. A system according to any of the preceding examples, wherein the fluid extraction cavity is shaped and sized for subcutaneous implantation.

[0033] Example 24. A system according to any of the preceding examples, wherein the control unit is thin.

[0034] Example 25. An implantable fluid extraction system, the fluid extraction system being shaped and sized to be implanted in a patient, the fluid extraction system comprising:

[0035] a fluid extraction chamber connected to a drainage tube, wherein the chamber extracts fluid by applying a negative pressure on a tissue;

[0036] a control unit sized for subcutaneous implantation and connected to the drainage tube; wherein the control unit comprises:

[0037] a sensor for measuring a plurality of values ​​of at least one result of the fluid extraction treatment regimen; and

[0038] A control circuit is connected to the sensor, wherein the control circuit receives feedback on the treatment by analyzing the plurality of values.

[0039] Example 26. A system as in Example 25, wherein the system further comprises: a memory for storing a regimen for the treatment or a portion of the treatment, and wherein the system further comprises: a pump for applying negative pressure to the fluid extraction chamber.

[0040] Example 27. A system as in Example 25, wherein the control unit includes: a communication circuit, if the multiple values ​​of the at least one result do not fall within an expected value range, the communication circuit is used to send a signal to a handheld device or a remote computer to generate a warning signal.

[0041] Example 28. The system of any one of Examples 25 to 27, wherein the fluid extraction cavity is shaped and sized for subcutaneous implantation.

[0042] Example 29. An implantable fluid extraction cavity, the fluid extraction cavity comprising:

[0043] a permeable bag preformed to form a thin body, wherein the bag includes an opening; and

[0044] An internal support is configured to be deployed into the bag through the opening, wherein the internal support maintains the thin body of the bag.

[0045] Example 30. The cavity of Example 29, wherein the cavity is small enough to be placed in the peritoneum.

[0046] Example 31. The chamber of example 29 or 30, wherein the permeable bag is preformed to form a flat and thin body.

[0047] Example 32. The cavity of Example 29, further comprising a porous membrane layer on an outer surface of the bag.

[0048] Example 33. The cavity of Example 29, further comprising a porous membrane within a chamber of the bag.

[0049] Example 34. The chamber of Example 29, wherein the bag is at least partially made of a porous membrane layer.

[0050] Example 35. A cavity according to any one of Examples 29 to 34, wherein the internal support comprises: an internal elongated stylet placed in an inner cavity of the internal support, wherein the stylet maintains the thin body of the permeable bag.

[0051] Example 36. The cavity of Example 35, wherein the internal stylet has a flat and thin cross-section.

[0052] Example 37. The cavity of Example 35, wherein the internal stylet has a rectangular cross-section.

[0053] Example 38. The cavity of Example 35, wherein the internal stylet has a circular cross-section.

[0054] Example 39. The cavity of any one of Examples 35 to 38, wherein the internal stylet is made of a shape memory material.

[0055] Example 40. The chamber of any one of Examples 32 to 34, wherein a maximum dimension of the plurality of pores of the membrane is less than 10 microns.

[0056] Example 41. A chamber according to any one of Examples 31 to 40, wherein the internal support includes a connector, and wherein the connector limits the movement of the internal support relative to the bag.

[0057] Example 42. The cavity of any one of Examples 29 to 41, wherein the internal support comprises a tube.

[0058] Example 43. The cavity of Example 29, wherein the internal support comprises a plurality of beads.

[0059] Example 44. The chamber of Example 43, wherein the plurality of beads comprises ionically charged beads.

[0060] Example 45. The cavity of Example 43 or 44, wherein a smallest dimension of the plurality of beads is at least 1 mm in diameter.

[0061] Example 46. The cavity according to any one of Examples 29 to 45, wherein the bag comprises two flat layers connected to each other along the periphery of the plurality of layers;

[0062] And wherein the two planar layers are connected at at least one connection point in an area surrounded by the periphery.

[0063] Example 47. The cavity of Example 29, wherein the internal support comprises a network of tubes.

[0064] Example 48. A cavity according to Example 47, wherein the tube network is filled with a colloid or a self-polymerizing material.

[0065] Example 49. The chamber of Example 47 or 48, wherein an outer surface of the bag is made of a porous membrane.

[0066] Example 50. A cavity according to Example 47 or 48, wherein the cavity comprises a porous membrane layer on the outer surface of the bag.

[0067] Example 51. A cavity according to Example 47 or 48, wherein the cavity comprises a porous membrane within a chamber of the bag.

[0068] Example 52. An implantable fluid extraction cavity, the fluid extraction cavity comprising:

[0069] a permeable bag comprising two planar layers connected to each other along a periphery of the plurality of layers;

[0070] And wherein the two planar layers are connected at at least one connection point in an area surrounded by the periphery.

[0071] Example 53. An implantable fluid extraction system, the fluid extraction system being shaped and sized to be implanted in a patient, the fluid extraction system comprising:

[0072] a fluid extraction chamber connected to a drainage tube, wherein the chamber extracts fluid by applying a negative pressure on a tissue;

[0073] A control unit connected to the drainage pipe; wherein the control unit comprises:

[0074] A pump is provided, wherein the pump applies negative pressure and positive pressure to the discharge tube.

[0075] Example 54. A system according to Example 53, wherein the fluid extraction chamber applies the negative pressure of higher intensity and lower intensity.

[0076] Example 55. A system according to Example 53 or 54, wherein a control circuit of the control unit sends a signal to the pump to apply higher and lower intensities of the negative pressure and the positive pressure.

[0077] Example 56. A system according to any of Examples 53 to 55, wherein the pump is a rotary pump, and wherein the rotary pump rotates in opposite directions to apply the negative and positive pressures.

[0078] Example 57. A method for deploying a fluid extraction chamber, the fluid extraction chamber comprising:

[0079] Introducing a flat fluid extraction cavity having a discharge outlet into the integral cavity;

[0080] inserting an internal stent into a chamber of the cavity; and

[0081] Connect the drain outlet to a sink.

[0082] Example 58. The method of Example 57, wherein the tank comprises a reservoir, a bladder, or a renal pelvis.

[0083] Example 59. The method of Example 57, comprising limiting movement of the interior relative to the flat fluid extraction cavity.

[0084] Example 60. The method of any one of Examples 57 to 59, wherein the connecting comprises: connecting the drain outlet to a pump.

[0085] Example 61. The method of any one of Examples 57 to 60, wherein the introducing comprises: introducing the flat fluid extraction cavity via an introduction element connected to the drainage tube, wherein the introduction element is more rigid than the drainage outlet.

[0086] Example 62. The method according to any one of Examples 57 to 61, wherein the introducing comprises: introducing a folded flat fluid extraction cavity having a drainage outlet into the integral cavity.

[0087] Example 63. The method according to Example 62, further comprising: after the introducing, unfolding the folded flat fluid extraction cavity.

[0088] Example 64. A method for changing a fluid extraction therapy, the method comprising:

[0089] When treating a patient, measuring multiple values ​​of at least one physiological parameter related to the treatment through at least one sensor of a control unit; and

[0090] A regimen of the treatment or a portion of the regimen of the treatment is altered based on the measurements made by a control circuit of the unit.

[0091] Example 65. A method according to Example 64, wherein the measurement includes: measuring multiple values ​​of at least one physiological parameter of the patient, wherein the physiological parameter includes fluid congestion, blood pressure, weight and / or heart rate.

[0092] Example 66. The method of Example 64 or 65, wherein the measuring comprises: measuring congestion or an indication of congestion.

[0093] Example 67. The method of Example 66, further comprising: evaluating a recovery time of interstitial pressure based on the congestion or an indication of the congestion.

[0094] Example 68. A method according to Example 67, wherein the changing includes: changing the pressure applied to the tissue, the duration of pressure application, and / or the duty cycle based on multiple results of the evaluation.

[0095] Example 69. A method according to any one of Examples 64 to 68, wherein the measurement includes: measuring the level of a biological substance and / or a chemical substance in the patient's blood.

[0096] Example 70. The method of any one of Examples 64 to 69, wherein the measuring comprises measuring a plurality of values ​​of at least one parameter of the fluid extracted from the patient.

[0097] Example 71. The method of Example 70, wherein the at least one parameter regarding the extracted fluid includes the flow of the extracted fluid, the pressure of the extracted fluid, and the volume of the extracted fluid.

[0098] Example 72. The method of Example 70 or 71, wherein the at least one parameter regarding the extracted fluid includes levels of multiple biological and / or chemical substances in the extracted fluid.

[0099] Example 73. The method of Example 72, wherein the plurality of biological and / or chemical substances comprises creatinine, urea, sodium, potassium, phosphate and / or albumin.

[0100] Example 74. A method according to any one of Examples 64 to 73, wherein the method comprises: storing the measured value in a memory of the control unit.

[0101] Example 75. A method for extracting fluid from a tissue via a fluid extraction cavity implanted in the peritoneum, the method comprising:

[0102] placing the fluid extraction lumen in contact with the tissue; and

[0103] A high level of negative pressure and then a low level of negative pressure are actively applied to the cavity by a pump.

[0104] Example 76. A method for varying a fluid extraction therapy and a second therapy through a device, the method comprising:

[0105] measuring a plurality of values ​​of at least one result of the plurality of treatments; and

[0106] The fluid withdrawal therapy and / or the second therapy are altered based on the plurality of measured values ​​of the at least one result.

[0107] Several additional examples of some embodiments of the present invention are listed below. It should be noted that several features from one example can be combined with one or more features from other examples:

[0108] Example 1. An implantable fluid extraction system, the shape and size of the fluid extraction system being convenient for implantation into a patient, the fluid extraction system comprising:

[0109] A fluid extraction chamber having a flat and thin shape, the fluid extraction chamber is connected to a drainage tube and includes at least one external flat surface, wherein when a negative pressure is applied to the drainage tube, the at least one external flat surface is configured to adhere to a tissue surface, wherein the chamber utilizes the negative pressure applied by the flat surface on the attached tissue surface to extract fluid from the tissue.

[0110] Example 2. The system according to Example 1, wherein the system comprises a control unit connected to the drainage tube, wherein the control unit comprises a pump for applying the negative pressure to the drainage tube.

[0111] Example 3. The system of any of Examples 1 or 2, comprising an internal skeleton configured to be inserted into the fluid extraction cavity and configured to stretch the fluid extraction cavity to maintain the flat and thin shape.

[0112] Example 4. A system according to Example 3, wherein the internal skeleton comprises an elastic metal mesh.

[0113] Example 5. The system according to Example 2, wherein the control unit comprises:

[0114] a memory for storing at least one treatment plan or a portion of the at least one treatment plan; and

[0115] a control circuit, wherein the control circuit activates the pump according to the treatment plan.

[0116] Example 6. The system of Example 5, wherein the control circuit signals the pump to intermittently apply the negative pressure to the drainage tube.

[0117] Example 7. The system of any of Examples 1 to 6, wherein the fluid extraction chamber comprises a porous membrane, and wherein the at least one planar surface is a planar surface of the porous membrane.

[0118] Example 8. The system of Example 7, wherein the porous membrane comprises a plurality of pores, and wherein a width of the plurality of pores is less than 5 microns.

[0119] Example 9. A system according to any of the preceding examples, wherein the shape and size of the at least one planar surface at least partially conform to the shape and / or contour of the attached tissue.

[0120] Example 10. The system of Example 5, further comprising: at least one implanted physiological sensor connected to the control circuit; wherein the sensor measures a plurality of values ​​related to at least one physiological parameter of the patient.

[0121] Example 11. A system according to Example 10, wherein the at least one physiological parameter includes interstitial pressure, and / or blood pressure, and / or blood content, and / or heart rate of the patient.

[0122] Example 12. A system according to Example 11, wherein the physiological sensor measures the levels of creatinine, and / or albumin, and / or sodium, and / or potassium, and / or urea, and / or phosphate in the contents of the blood.

[0123] Example 13. The system of any of Examples 10 to 12, wherein the at least one physiological parameter comprises an indication of congestion.

[0124] Example 14. The system of Example 5, further comprising: at least one implanted extraction sensor connected to the control circuit, wherein the sensor measures multiple values ​​of at least one parameter related to the extracted fluid.

[0125] Example 15. The system of Example 14, wherein the at least one parameter comprises the flow of the extracted fluid, and / or the pressure of the extracted fluid, and / or the volume of the extracted fluid.

[0126] Example 16. The system of any of Examples 14 or 15, wherein the at least one parameter comprises levels of a plurality of biological and / or chemical substances in the extracted fluid.

[0127] Example 17. A system according to Example 16, wherein the plurality of substances comprises creatinine, and / or albumin, and / or sodium, and / or potassium, and / or urea, and / or phosphate.

[0128] Example 18. The system of any of Examples 14 to 17, wherein the extraction sensor measures congestion or an indication of congestion.

[0129] Example 19. The system of any of the preceding examples, further comprising: a catheter fluidly connected to the drainage tube, wherein the catheter has a tip connected to the urinary system.

[0130] Example 20. The system of any of the preceding examples, further comprising: a reservoir fluidly connected to the drainage tube, wherein the reservoir is shaped and sized to store the extracted fluid.

[0131] Example 21. A system according to Example 5, wherein the control unit further comprises: a communication circuit connected to the control circuit, wherein the communication circuit is connected to a handheld device and / or a remote computer via wireless communication.

[0132] Example 22. The system of Example 21, wherein the communication circuit sends a signal to the handheld device and / or the remote computer to generate a warning signal.

[0133] Example 23. The system of Example 21 or 22, wherein the communication circuit receives information from a handheld device and / or a remote computer, and wherein the information is stored in the memory.

[0134] Example 24. The system of Example 5, wherein the system further comprises: a battery connected to the control unit, wherein the battery provides power to the control unit.

[0135] Example 25. A system according to any of the preceding examples, wherein the fluid extraction cavity is shaped and sized to directly contact the tissue of multiple organs located in the abdominal cavity.

[0136] Example 26. A system according to any of the preceding examples, wherein the fluid extraction cavity is shaped and sized for subcutaneous implantation.

[0137] Example 27. An implantable fluid extraction cavity, the fluid extraction cavity comprising:

[0138] a permeable bag preformed to form a flat, thin body, wherein the bag includes an opening; and

[0139] An elastic inner support is configured to be deployed into the bag through the opening, wherein the elastic inner support stretches the bag to maintain the flat and thin shape of the bag.

[0140] Example 28. The chamber of Example 27, wherein the resilient inner support is sufficiently rigid to prevent the permeable bag from collapsing inwardly when a vacuum is applied to an interior cavity of the permeable bag.

[0141] Example 29. The cavity of any of Examples 27 or 28, wherein the cavity is small enough to be placed in the peritoneum.

[0142] Example 30. The cavity according to any one of Examples 27 to 29, further comprising a porous membrane layer on an outer surface of the bag.

[0143] Example 31. The cavity according to any one of Examples 27 to 29, further comprising a porous membrane in a chamber of the bag.

[0144] Example 32. The chamber according to any one of Examples 27 to 29, wherein the bag is at least partially made of a porous membrane layer.

[0145] Example 33. A cavity according to any one of Examples 27 to 32, wherein the internal support comprises: an internal elongated stylet placed in an inner cavity of the internal support, wherein the stylet maintains the thin body of the permeable bag.

[0146] Example 34. The cavity of Example 33, wherein the internal stylet has a flat and thin cross-section or a circular cross-section.

[0147] Example 35. The cavity of any one of Examples 27 to 34, wherein the inner support comprises a braided tube.

[0148] Example 36. The chamber of any of Examples 30 to 32, wherein a maximum dimension of the plurality of pores of the membrane is less than 5 microns.

[0149] Example 37. The chamber of any one of Examples 27 to 36, wherein the inner support comprises a connector, and wherein the connector limits movement of the inner support relative to the permeable bag.

[0150] Example 38. The chamber according to any one of Examples 27 to 37, wherein the permeable bag comprises two flat layers connected to each other along the periphery of the plurality of layers;

[0151] And wherein the two planar layers are connected at at least one connection point in an area surrounded by the periphery.

[0152] Example 39. The cavity according to any one of Examples 27 to 38, wherein the internal support comprises a tube or a plurality of beads.

[0153] Example 40. An implantable fluid extraction system, the fluid extraction system being shaped and sized to be implanted in a patient, the fluid extraction system comprising:

[0154] a fluid extraction chamber connected to a drainage tube, wherein the fluid extraction chamber has at least one flat and porous outer membrane shaped and sized to contact a tissue surface; and

[0155] A control unit is connected to the drain pipe, wherein the control unit controls the level of negative pressure generated on the drain pipe according to a scheme so as to mechanically vibrate the at least one flat and porous outer membrane.

[0156] Example 41. The system of Example 40, wherein the control unit comprises:

[0157] a vacuum pump connected to the drain pipe and configured to generate negative pressure; and

[0158] A control circuit is electrically connected to the pump, and the pump is configured to control the negative pressure generated by the pump.

[0159] Example 42. A system according to Example 41, wherein the control circuit sends a signal to the vacuum pump to generate multiple short pulses of low level negative pressure, wherein the multiple short pulses are sufficient to generate the negative pressure applied to the drainage tube.

[0160] Example 43. A system according to any one of Examples 41 or 42, wherein the system includes at least one valve electrically connected to the control circuit and positioned on the drain pipe, wherein the control circuit sends a signal to the valve to close or open the drain pipe when the vacuum pump generates the negative pressure.

[0161] Example 44. A system according to any one of Examples 41 to 43, wherein the system further comprises: a flow path connected to the discharge pipe and an outlet of the pump; and at least one valve controlled by the control circuit and positioned on the flow path, wherein the at least one valve controls the flow through the flow path.

[0162] Example 45. The system of Example 44, wherein the control circuit signals the valve to close or open the flow path when the pump generates the negative pressure.

[0163] Example 46. A method for deploying a fluid extraction chamber, the method comprising:

[0164] Introducing a flat fluid extraction cavity having a discharge outlet into the integral cavity;

[0165] inserting a resilient inner support into a chamber of the cavity to shape the flat cavity; and

[0166] Connect the drain outlet to a sink.

[0167] Example 47. The method of Example 46, wherein the tank comprises a reservoir, a bladder, or a renal pelvis.

[0168] Example 48. The method of any one of Examples 46 or 47, comprising: connecting the internal support to a port of the flat cavity to limit movement of the internal support relative to the flat fluid extraction cavity.

[0169] Example 49. The method of any one of Examples 46 to 48, wherein the connecting comprises: connecting the drain outlet to a pump.

[0170] Example 50. The method of Example 49, comprising: applying a negative pressure through the drainage outlet on an inner cavity of the flat fluid extraction cavity using the pump.

[0171] Example 51. The method of Example 50, comprising: during the application of the negative pressure, causing an outer surface of the flat fluid extraction cavity to tightly adhere to a tissue surface.

[0172] Example 52. The method of any one of Examples 46 to 51, wherein the introducing comprises: introducing the flat fluid extraction cavity via an introduction element connected to the drainage tube, wherein the introduction element is more rigid than the drainage outlet.

[0173] Example 53. The method according to any one of Examples 46 to 52, wherein the introducing of the flat fluid extraction cavity comprises: introducing a folded flat fluid extraction cavity having a drainage outlet into the integral cavity.

[0174] Example 54. The method according to Example 53, further comprising: after the introducing, unfolding the folded flat fluid extraction cavity.

[0175] Example 55. A method for altering a subject, the method comprising:

[0176] placing at least one planar surface of a thin fluid extraction chamber in direct contact with a surface of a tissue;

[0177] Actively applying a negative pressure to a drainage tube connected to the cavity through a pump;

[0178] The negative pressure is maintained at a constant or varying level sufficient to remove at least 100 milliliters of fluid from the subject per day.

[0179] Unless otherwise defined, all technical and / or scientific terms used herein have the same meaning as those commonly understood by those of ordinary skill in the art to which the invention belongs. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of multiple embodiments of the present invention, multiple exemplary methods and / or materials are described below. In the event of a conflict, the patent specification including multiple definitions shall prevail. In addition, the multiple materials, methods and examples are illustrative only and are not intended to be necessarily limiting.

[0180] As will be appreciated by those skilled in the art, some embodiments of the present invention may be implemented as a system, a method or a computer program product. Therefore, some embodiments of the present invention may take the form of a complete hardware embodiment, a complete software embodiment (including firmware, resident software, microcode, etc.) or an embodiment combining software and hardware, which embodiments may generally be referred to as "circuit", "module" or "system". In addition, some embodiments of the present invention may take the form of a computer program product, which is implemented in one or more computer-readable media, and the computer-readable media has a computer-readable program code embodied thereon. The implementation of the method and / or system of some embodiments of the present invention may involve performing and / or completing multiple selected tasks manually, automatically or in combination thereof. Moreover, according to the actual instruments and equipment of some embodiments of the method and / or system of the present invention, multiple selected tasks may be implemented by hardware, software or firmware and / or a combination thereof, for example, using an operating system.

[0181] For example, according to some embodiments of the present invention, the hardware for performing a plurality of selected tasks may be implemented as a chip or a circuit. Taking software as an example, a plurality of selected tasks according to some embodiments of the present invention may be implemented as a plurality of software instructions, which are executed by a computer using any suitable operating system. In an exemplary embodiment of the present invention, according to some exemplary embodiments of the method and / or system described herein, one or more of the tasks 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 a plurality of instructions and / or data, and / or an invariant memory for storing a plurality of instructions and / or data, such as a magnetic hard disk and / or a removable medium. Optionally, a network connection is also provided. A display and / or a user input device, such as a keyboard or a mouse, may also be selectively provided.

[0182] Any combination of one or more computer-readable media may be utilized in various embodiments of the present 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, but is not limited to, for example, an electronic, magnetic, optical, electromagnetic, infrared or semiconductor system, device or apparatus, or any suitable combination of the foregoing. More specific examples of the computer-readable storage medium (a non-exhaustive list) would include the following: an electrical connection having one or more wires, a portable computer disk, a hard disk, a random access memory (RAM), a read-only memory (ROM), an erasable programmable read-only memory (EPROM or flash memory), an optical fiber, a portable compact disk 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 may contain, or store a program for use by or in connection with an instruction execution system, device or apparatus.

[0183] A computer readable signal medium may include a propagable data signal having a computer readable program code embodied thereon, for example, in a baseband or as part of a carrier wave. Such a propagable signal may take any of a variety of forms, including, but not limited to, electromagnetic, optical, or any suitable combination thereof. A computer readable signal medium may be any computer readable medium that is not a computer readable storage medium and that can communicate, propagate, or transport a program for use by or in connection with an instruction execution system, apparatus, or device.

[0184] A program code embodied on a computer-readable medium and / or data used by it may be transmitted using any appropriate medium, including but not limited to wireless, wired, optical fiber cable, radio frequency, etc., or any suitable combination of the foregoing.

[0185] A computer program code is used to implement a plurality of operations for some embodiments of the present invention, and the computer program code may be written in any combination of one or more programming languages, including an object-oriented programming language such as Java, Smalltalk, C++, and a traditional procedural programming language such as the "C" programming language or a variety of similar programming languages. The program code may be executed entirely on a user's computer, partially on the user's computer, and as a stand-alone software package, partially on the user's computer and partially on a remote computer or entirely on the remote computer or a server. In the latter case, the remote computer may be connected to the user's computer via any type of network, including a local area network (LAN) or a wide area network (WAN), or may be connected to an external computer (e.g., via the Internet using an Internet service provider).

[0186] Some embodiments of the present invention are described below with reference to multiple flowchart illustrations / or multiple block diagrams of multiple methods, devices (systems) and computer program products according to multiple embodiments of the present invention. It should be understood that each block of the flowchart illustration and / or the block diagram, and the combination of multiple blocks in the flowchart illustration and / or the block diagram can be implemented by multiple computer program instructions. These computer program instructions can be provided to a processor of a general-purpose computer, a special-purpose computer or other programmable data processing device to produce a machine, so that the multiple instructions create a device, and the multiple instructions are executed by the processor of the computer or other programmable data processing device, and the device is used to implement multiple functions / actions specified in one or more blocks of the flowchart and / or the block diagram.

[0187] These computer program instructions may also be stored in a computer-readable medium, which may direct a computer, other programmable data processing device, or other apparatus to function in a specific manner so that the multiple instructions stored in the computer-readable medium produce a product comprising the multiple instructions, and the multiple instructions implement the multiple functions / actions specified in one or more blocks of the flowchart and / or the block diagram.

[0188] The multiple computer program instructions can also be loaded onto a computer, other programmable data processing equipment or other devices to perform a series of operating steps on the computer, other programmable equipment or other devices, thereby generating a computer-implemented process, so that the multiple instructions executed on the computer or other programmable devices provide multiple processes, which are used to implement the multiple functions / actions specified in one or more blocks of the flowchart and / or the block diagram.

[0189] Some of the methods described herein are generally designed only for use by a computer, and may not be feasible or practical for a human expert to perform completely manually. A human expert who wishes to manually perform similar tasks, such as monitoring and changing a fluid extraction therapy, may be expected to use an entirely different approach, for example, utilizing expert knowledge and / or pattern recognition capabilities of the human brain, which would be more efficient than manually performing the steps of the methods described herein. BRIEF DESCRIPTION OF THE DRAWINGS

[0190] Some embodiments of the present invention are described herein with reference to the accompanying drawings by way of example only. With specific and detailed reference now to the accompanying drawings, it is emphasized that the details shown are by way of example and for purposes of illustrative discussion of the various embodiments of the present invention. In this regard, the description by way of the accompanying drawings makes it clear to those skilled in the art how to implement the various embodiments of the present invention.

[0191] In several of the accompanying drawings:

[0192] Figure 1 is a block diagram of an implantable system and apparatus for removing fluid from a body organ according to some embodiments of the present invention;

[0193] Figure 2A is a schematic illustration of some embodiments of the present invention showing an implantable system for removing fluid from a body having a plurality of external elements;

[0194] Figure 2B is a flow chart according to some embodiments of the present invention, the flow chart describing the flow of fluid between multiple biological compartments and the implanted system;

[0195] Figures 3A to 3N are schematic illustrations of a fluid extraction chamber having an internal helical stent according to some embodiments of the present invention;

[0196] Figures 4A to 4C are multiple images of a membrane covering a fluid extraction chamber having an internal helical stent according to some embodiments of the present invention;

[0197] Figures 5A to 5G are schematic illustrations of a deployment process of a fluid extraction system according to some embodiments of the present invention, the fluid extraction system comprising a fluid extraction chamber having an internal helical stent;

[0198] Figure 6A flow chart describing a deployment process of a fluid extraction system according to some embodiments of the present invention, the fluid extraction system comprising a fluid extraction chamber having an internal spiral stent;

[0199] Fig. 7A is an image of a fluid extraction chamber filled with a plurality of beads according to some embodiments of the present invention;

[0200] Figure 7B A flow chart describing a deployment process of an extraction chamber filled with beads according to some embodiments of the present invention;

[0201] Fig. 8A is an image of a fluid extraction chamber filled with a colloid according to some embodiments of the present invention;

[0202] Figure 8B A flow chart describing a deployment process of an extraction chamber filled with colloid according to some embodiments of the present invention;

[0203] Fig. 9A is a schematic illustration of multiple input sources affecting a fluid extraction therapy according to some embodiments of the present invention;

[0204] Fig. 9B is a schematic illustration of multiple input types affecting a fluid extraction therapy according to some embodiments of the present invention;

[0205] Fig. 9C is a flow chart of a general process for changing a fluid extraction therapy according to some embodiments of the present invention;

[0206] Fig.9D A flow chart of a process for changing a fluid extraction therapy based on multiple clinical parameter measurements according to some embodiments of the present invention;

[0207] Fig.9E A flow chart of a process for varying a fluid extraction therapy based on multiple measurements of drained fluid according to some embodiments of the present invention;

[0208] Fig.9F A flow chart of a process for changing a fluid withdrawal therapy based on input received from the patient and / or a physician according to some embodiments of the present invention;

[0209] Figure 9G A flow chart of a setup and / or maintenance process of an implanted fluid extraction device according to some embodiments of the present invention;

[0210] Figures 10A to 10HA plurality of images, tables, and diagrams depicting a plurality of results of a plurality of supporting experiments according to some embodiments of the present invention;

[0211] Figures 11A to 11D are block diagrams of a plurality of fluid extraction systems according to some embodiments of the present invention, the plurality of fluid extraction systems including a plurality of pressure changing features;

[0212] Fig.11E A diagram depicting multiple variations of pressure applied within an absorption chamber according to some exemplary embodiments of the present invention;

[0213] Fig. 12A A graph depicting changes in concentration of proteins attached to two types of membranes under different pressure conditions according to some embodiments of the present invention;

[0214] Fig. 12B is a graphical representation showing variations in pressure relative to a baseline pressure level under different conditions according to some embodiments of the present invention;

[0215] Fig.13A and 13B are multiple schematic illustrations of an introduction system according to some embodiments of the present invention;

[0216] Figures 14A to 14D A plurality of illustrations of an absorbent cavity for releasing an introduction system according to some embodiments of the present invention;

[0217] Fig.14E is an illustration of a port connector according to some embodiments of the present invention; and

[0218] Fig.15 is a schematic illustration of an absorbent cavity having an internal expandable wire according to some embodiments of the present invention. DETAILED DESCRIPTION

[0219] In some embodiments of the present invention, the present invention relates to a fluid extraction system, and particularly, but not exclusively, to an implantable fluid extraction system.

[0220] A broad aspect of some embodiments relates to adjusting a fluid extraction therapy based on a clinical condition of a subject. In some embodiments, the therapy is adjusted based on a disease of a subject. Alternatively or additionally, the therapy is adjusted based on a plurality of measured clinical parameters during and / or after the therapy.

[0221] An aspect of some embodiments relates to an implantable fluid extraction device or system having at least one sensor. In some embodiments, the sensor measures a plurality of clinical parameters of the patient, such as temperature, blood pressure, blood content and / or congestion level. Alternatively or additionally, the sensor measures the content of the extracted and / or drained fluid. In some embodiments, after the sensor performs the measurement, at least one parameter related to activation of the device is changed.

[0222] An aspect of some embodiments relates to an implantable fluid extraction device or system having a memory. In some embodiments, the memory stores multiple treatment plans and / or multiple activation plans for the device. Alternatively or additionally, the memory stores multiple values ​​of at least one treatment parameter. In some embodiments, the device is activated based on the multiple treatment plans and / or the multiple activation plans stored in the memory. In some embodiments, the memory stores multiple log files of the device and / or multiple values ​​of multiple clinical parameters measured by the device.

[0223] An aspect of some embodiments relates to automatically changing at least one treatment parameter during a fluid withdrawal treatment. In some embodiments, the at least one treatment parameter is changed based on a plurality of clinical parameter measurements and / or inputs received from the patient during the treatment. Alternatively or additionally, the treatment is changed based on inputs received from a physician. In some embodiments, the treatment is automatically changed based on an output of the treatment.

[0224] In some embodiments, the at least one treatment parameter is changed based on a protocol table or a plurality of protocol settings, for example, by comparing a plurality of measured values ​​of a plurality of parameters with a plurality of values ​​or a plurality of indicated values ​​in the table. In some embodiments, the protocol and / or the treatment is changed based on the plurality of results of the treatment. Optionally, the table is stored in a memory of the control unit.

[0225] An aspect of some embodiments relates to an implanted permeable bag having a membrane. In some embodiments, the bag is at least partially covered by the membrane. Alternatively or additionally, the membrane is positioned within the chamber of the bag. In some embodiments, the bag and / or the membrane are porous. In some embodiments, the size of the plurality of pores is less than the size of a cell. In some embodiments, the bag is a foldable bag.

[0226] In some embodiments, the bag is made of a permeable membrane. In some embodiments, the membrane is formed into a bag. In some embodiments, a portion of the bag is impermeable to fluids. In some embodiments, the bag is spherical. In some implementations, a maximum dimension of the bag is less than 30 cm, such as 20, 15, 12 cm, or any intermediate or smaller value.

[0227] In some embodiments, the bag and / or the membrane are shaped and sized to indirectly contact a tissue, such as tissue of multiple organs located within the peritoneum. In some embodiments, the bag and / or the membrane are shaped and sized to directly contact a column or a portion of columnar tissue. In some embodiments, the membrane is shaped and sized to directly and intimately contact the tissue, such as when a high level of negative pressure, such as a vacuum, is applied through the membrane on the tissue. As used herein, intimate contact between a portion of the absorbent cavity, such as an absorbent cavity, a bag and / or a surface of a permeable membrane, and a tissue is an interaction wherein at least 30% of the surface area of ​​the contacting portion is less than 150 microns. Alternatively or in addition, intimate contact between a portion of the absorbent cavity, such as an absorbent cavity, a bag and / or a surface of a permeable membrane, and a tissue is an interaction wherein the contact facilitates application of a peak inward force of at least 25 Newtons (N) on the contacted tissue.

[0228] In some embodiments, the bag and / or the film are flat or thin, for example, a ratio between a minimum dimension and a maximum dimension of the bag and / or the film is at least 1:3, for example 1:4, 1:5, or any intermediate or greater ratio. In some embodiments, an outer dimension of the bag is less than 25 cm, for example 20, 17, 15 cm, or any intermediate or smaller value. In some embodiments, the bag comprises at least one flat surface, the at least one flat surface having a shape and size for direct and optionally intimate contact with the tissue.

[0229] According to some embodiments, the bag comprises at least one flat surface, the at least one flat surface being shaped and sized to conform, also referred to herein as conforming, to a shape and / or a structure of a tissue or an external surface of the tissue, for example, so as to maintain a close attachment between the at least one flat surface and the tissue. In some embodiments, the at least one flat surface is positioned to directly contact a tissue and / or a tissue surface, optionally in a direct and close contact. In some embodiments, fluid is drawn directly from the tissue and into the bag by the flat surface of the bag being closely attached to the tissue. In some embodiments, fluid from the tissue is not drawn directly into the bag through multiple external areas of the bag that are not attached to the tissue surface.

[0230] According to some embodiments, the bag, the film and / or an absorbent cavity are preformed to be flat and thin. In some embodiments, the bag, the film and / or an absorbent cavity conforms to an outer shape of a tissue and / or an anatomical contour of the tissue by having a loose and elastic outer surface.

[0231] An aspect of some embodiments relates to a permeable bag having a deployable internal support. In some embodiments, the internal support keeps the bag flat. In some embodiments, the internal support provides mechanical strength to the bag. Alternatively or additionally, the internal support allows fluid to drain from the bag.

[0232] In some embodiments, the bag has a preformed shape. In some embodiments, the shape of the deployable inner stent is preformed to the shape of the bag. In some embodiments, the inner stent comprises a braided tube. Alternatively, the stent comprises a coil. In some embodiments, the inner stent comprises an inner stylet, for example, to keep the deployed inner stent flat. Optionally, the stylet has a rectangular cross-section. In some embodiments, the stylet is made of a shape memory material, such as a nickel-titanium alloy.

[0233] In some embodiments, the bag is shaped and sized for implantation into a body cavity, such as the peritoneum. Alternatively, the bag is shaped and sized for subcutaneous implantation. In some embodiments, the bag is flat and / or thin. In some embodiments, the bag is in direct contact with the tissue.

[0234] One aspect of some embodiments relates to a permeable bag comprising two surfaces connected at at least two connection points. In some embodiments, the multiple surfaces are connected at at least two locations to limit the minimum size of the bag. In some embodiments, the multiple surfaces are connected at at least two locations to prevent the bag from expanding. In some embodiments, the two connection points are located at a distance of at least 1 / 3 of the diameter of the bag from the periphery of the bag. Alternatively or in addition, the multiple surfaces are connected at at least two locations to allow uniform distribution of an internal scaffold made of multiple particles, for example, multiple beads throughout the entire chamber of the bag. In some embodiments, the at least two connection points form an opening to allow fluid to pass through the bag without entering the chamber of the bag.

[0235] In some embodiments, the bag is shaped and sized for implantation into a body cavity, such as the peritoneum. Alternatively, the bag is shaped and sized for subcutaneous implantation. In some embodiments, the bag is flat and / or thin. In some embodiments, the bag is in direct contact with the tissue.

[0236] One aspect of some embodiments relates to the deployment of a folded bag that is unfolded, structurally stable, and locked in a stable state. In some embodiments, the bag is stabilized by inserting a colloid or a self-polymerizing fluid into an internal support located inside the bag. In some embodiments, the bag is locked in a stable state by locking the internal support relative to the bag. In some embodiments, the internal support is locked to a connector that is positioned in an insertion site where the support enters the bag. In some embodiments, the support is irreversibly locked, for example, by an interference locking mechanism. Alternatively, the internal support is reversibly locked, for example, by rotation of the connector. Optionally, the internal support is reversibly locked for multiple purposes of extraction by the device. In some embodiments, the movement of the internal support is restricted within the bag.

[0237] In some embodiments, the bag is shaped and sized for implantation into a body cavity, such as the peritoneum. Alternatively, the bag is shaped and sized for subcutaneous implantation. In some embodiments, the bag is flat and / or thin. In some embodiments, the bag is in direct contact with the tissue.

[0238] According to some embodiments, the folded bag is deployed and locked in a secure state that allows direct and optionally tight attachment between a membrane associated with the bag, such as a membrane forming the bag, or a membrane located within the bag or outside the bag, and the tissue. In some embodiments, the folded bag is deployed and locked in a secure state that allows direct and optionally tight attachment between the bag and an external surface of the tissue.

[0239] One aspect of some embodiments relates to extracting fluid from a tissue by actively applying negative pressure to the tissue intermittently. In some embodiments, a pump, such as a peristaltic pump, applies a high level of negative pressure to the tissue and then applies a low level of negative pressure. Optionally, the pump operates in multiple on:off duty cycles. Optionally, the pump is activated between 10% and 98% of the time when the fluid extraction chamber is implanted in the body, such as 10%, 15%, 25%, 50%, or any intermediate value.

[0240] In some embodiments, the plurality of duty cycles are adjusted to match the condition of the patient and / or the activity of the patient, for example, the patient's drinking, eating, and sleeping times.

[0241] An aspect of some embodiments relates to adjusting a protocol of a fluid extraction therapy or a device used in said therapy to accommodate multiple additional therapies and / or physiological activities. In some embodiments, the fluid extraction therapy is adjusted to accommodate renal filtration rate and / or fluid accumulation rate. In some embodiments, a fluid extraction system actively applies a reduced vacuum force to efficiently extract fluid from said tissue. In some embodiments, a fluid extraction system applies a protocol of reduced drain timing to efficiently extract fluid from said tissue. In some embodiments, when the efficiency of renal filtration is improved, the device applies a reduced vacuum force and / or a protocol of reduced drain timing. In some embodiments, the protocol or the therapy is adjusted to achieve a desired relative drainage rate of 0.01% to 0.05% of body weight per hour (0.27% to 1.2% / day).

[0242] In some embodiments, a regimen of at least one additional therapy is altered. In some embodiments, the regimen or a portion of the regimen of the additional therapy is altered based on an output measured by the device.

[0243] One aspect of some embodiments relates to applying positive pressure on a fluid extraction chamber to remove a plurality of unwanted substances attached to the chamber. It should be noted that when applying positive pressure, the total pressure applied to the tissue or applied to the fluid extraction chamber remains negative. In some embodiments, a positive pressure is applied to remove proteins, tissues and / or cells attached to the fluid extraction chamber. In some embodiments, the positive pressure is applied to remove proteins, tissues and / or cells attached to a membrane of the fluid extraction chamber. In some embodiments, the positive pressure is applied as a plurality of short positive pressure transient pulses, for example, by reversing the existing vacuum to a near neutral pressure or above the natural interstitial pressure (0 to 20 mmHg) for a short period of 0.1 to 10 seconds. Optionally, the plurality of said changes in pressure are gradual and / or relatively slow. In some embodiments, the positive pressure is applied together with a negative pressure applied, for example, by a vacuum pump, to achieve a total negative pressure. In some embodiments, when the total pressure on the tissue is negative, the membrane remains attached to the tissue. Alternatively, if the total pressure is a positive pressure, the membrane is at least partially separated from the tissue. In some embodiments, the total pressure is zero. In some embodiments, when the total pressure is zero or positive, the membrane moves to a different position, for example, so as to be placed in contact with a different tissue area or with a different tissue.

[0244] According to some embodiments, application of high and low levels of negative pressure on a drain connected to a fluid extraction chamber is used to mechanically vibrate a membrane associated with the chamber, for example, a membrane contacting the tissue.

[0245] According to some embodiments, the positive pressure is applied by a pump, for example, a peristaltic pump connected to the cavity. In some embodiments, the pump is connected to an outlet of the cavity, or to a drain connected to the outlet. In some embodiments, the positive pressure is applied by the pump on the drain connected to the cavity. In some embodiments, the pump rotates in a first direction to apply a negative pressure on the cavity, and rotates in a second direction to apply a positive pressure on the cavity. In some embodiments, the rotation direction of the pump is reversed to switch between the first direction and the second direction.

[0246] According to some embodiments, at least one valve is positioned in a fluid flow path that connects a pump and the chamber, the pump being configured to apply negative pressure. In some embodiments, the at least one valve, such as a solenoid valve and / or a pinch valve, is activated, for example, opened and closed to produce multiple diversions and / or multiple pressure changes in the fluid flow path and the chamber. In some embodiments, the at least one valve is opened and closed for a period of up to 1 second, such as 0.13 seconds, 0.5 seconds, 0.8 seconds, or any intermediate, shorter, or longer period of time.

[0247] According to some embodiments, the plurality of pressure changes are applied by activating a second pump located in the fluid flow path, the second pump being configured to generate the relative positive pressure step.

[0248] In some embodiments, the activation of the at least one valve and / or the activation of a pump to generate a positive pressure is controlled by a controller of the system. Optionally, the controller controls the activation of the at least one valve or the pump based on multiple signals transmitted by a sensor, such as a pressure sensor configured to sense multiple pressure changes in the fluid flow path away from the cavity and / or multiple pressure changes in the cavity.

[0249] According to some exemplary embodiments, in multiple subjects suffering from the following conditions: (1) left-sided heart failure and underlying chronic kidney disease; (2) right-sided heart failure, excluding symptoms of ascites; (3) biventricular heart failure; (4) Fontan failure; and (5) pulmonary hypertension with systemic congestion, the fluid withdrawal therapy using the systems and methods described herein is adjusted to withdraw fluid in the range of 150 to 500 ml per day.

[0250] According to some exemplary embodiments, in multiple subjects suffering from the following conditions: (1) stage IV and stage V chronic kidney disease; (2) end-stage renal disease; (3) abdominal compartment syndrome; (4) ascites symptoms associated with cirrhosis, portal hypertension, etc., the fluid extraction therapy using the systems and methods described herein will be adjusted to extract fluid in the range of 500 to 1000 ml per day.

[0251] Potential advantages of using the implantable system in one or more embodiments described herein are that the system is fully implantable and optionally drains fluid to the urinary system. Additional optional advantages in one or more described embodiments are that the system has no circulatory contact and optionally has a configurable operation. In some embodiments, the system uses a direct mechanism to extract fluid directly from the tissue. Additionally, in one or more embodiments described herein, the system applies pressure on the tissue intermittently and non-continuously.

[0252] Before explaining at least one embodiment of the present invention in detail, it should be understood that the present invention is not necessarily limited to the details of the structure and arrangement of the multiple components and / or multiple methods of its application set forth in the following description and / or illustrated in multiple figures and / or multiple examples.

[0253] Exemplary Implanted Systems

[0254] According to some exemplary embodiments, a device for draining fluid is implanted into a body cavity, for example, into the abdominal cavity. Figure 1 , which depicts an implantable device or an implantable system according to some embodiments of the present invention.

[0255] According to some exemplary embodiments, an implantable system, such as system 102, includes a fluid extraction cavity, such as a fluid absorption unit 104, which is shaped and sized to be placed in a body cavity, such as an abdominal cavity, or to facilitate subcutaneous implantation. In some embodiments, the absorption unit 104 has at least one flat side to contact a tissue. In some embodiments, the fluid extraction cavity, such as the fluid absorption unit, is flat, and / or thin, and / or curved, and / or dome-shaped. In some implementations, the fluid extraction cavity, such as the absorption unit 104 in some embodiments, includes an inner cavity 105 and an outer flat layer 108, and the outer flat layer 108 surrounds the inner cavity 105. In some embodiments, the outer flat layer 108 is shaped and sized to at least partially contact a tissue. In some embodiments, when contacting the tissue, fluid from the tissue passes directly through the outer flat layer 108 and enters the inner cavity 105 of the absorption unit 104. Optionally, the outer flat layer has a large surface area sufficient to directly absorb fluid from the tissue. In some embodiments, the passage of the fluid is passive due to pressure changes between the tissue and the lumen 105, for example, when the pressure in the tissue is higher than the pressure in the lumen 105. Alternatively, the fluid actively passes from the tissue and into the lumen when the pump is activated.

[0256] According to some exemplary embodiments, the outer planar layer 108 is a porous layer that can optionally form a bag. In some embodiments, an inner membrane, such as inner membrane 110, is positioned within the bag in the inner cavity 105. In some embodiments, the shape and size of the inner membrane 110 is used to absorb fluid directly from the tissue through the outer planar layer 108 and into the fluid absorbent unit 104.

[0257] According to some exemplary embodiments, the fluid absorption unit 104 includes an inner support 109, which can be optionally rigid or semi-rigid. In some embodiments, the inner skeleton 109 is stable and prevents the collapse of the outer flat layer. In some embodiments, the shape and size of the inner support are convenient for deployment and / or removal from the inner cavity 105. In some embodiments, the inner membrane 110 is attached to the inner support 109 when the inner support 109 is deployed or removed, for example, to allow removal and replacement of the membrane.

[0258] According to some exemplary embodiments, the fluid absorption unit 104 comprises at least one connector, such as connector 102, for connecting a drainage tube, such as an outlet tube 124, to the fluid absorption unit. In some embodiments, the outlet tube 124 is pushed into the chamber 105 and optionally as part of the inner support 109. In some embodiments, the fluid discharged from the tissue and entering the fluid absorption unit is removed through the outlet tube 124.

[0259] According to some exemplary embodiments, the system 102 includes an implantable control unit, such as the control unit 106. In some embodiments, the control unit 106 includes a pump 130, such as a peristaltic pump, connected to the outlet tube 124 via a connector 128. In some embodiments, the pump 130 is connected to a control circuit 114 of the control unit 106. In some embodiments, the control circuit 114 activates the pump 130 to remove absorbed fluid from the fluid absorbent unit 104. Alternatively or additionally, the control circuit 114 activates the pump 130, for example, to generate sufficient pressure, optionally negative pressure, to allow fluid to be drawn from the tissue and into the absorbent unit 104, for example, to remove various substances accumulated or attached to an external surface of the fluid absorbent unit 104. In some embodiments, the pump 130 generates positive pressure on the fluid absorbent unit to remove various substances, for example, tissue forming an external film layer located on the external surface of the fluid absorbent unit 104. In some embodiments, prior to applying positive pressure, the system 103 closes an internal reservoir, such as reservoir 136, and optionally seals a conduit connected to the urinary system from the fluid absorbent unit 104. In some embodiments, when the reservoir is closed, the reservoir contains at least some amount of the extracted fluid.

[0260] According to some exemplary embodiments, the pump 130 is mechanically connected to the outlet tube 124 and applies the negative pressure and / or the positive pressure to the outlet tube 124. In some embodiments, the control unit 106 controls the generation of high and low levels of negative pressure on the outlet tube, optionally according to a recipe, for example, a recipe stored in a memory 116. In some embodiments, the applied high and low levels of negative pressure are used to mechanically vibrate the absorption unit 104 and / or the outer flat layer 108, for example, to remove proteins, tissues and / or cells attached to the absorption unit 104 and / or the outer flat layer 108.

[0261] According to some exemplary embodiments, the pump 130 is connected to a reservoir 136, such as an internal reservoir or an external reservoir, via a tube 134. Alternatively or additionally, the pump 130 is connected to the urinary system, such as to the bladder or the renal pelvis, such as via a catheter 140. In some embodiments, the absorbed fluid from the fluid absorption unit 104 is discharged into the reservoir, such as an implantable or extracorporeal reservoir, and / or the bladder, via the control unit 106. In some embodiments, the pump 130 is activated so that the absorbed fluid is actively removed from the fluid absorption unit 104 and enters the reservoir 136 and / or the urinary system.

[0262] According to some exemplary embodiments, the control unit 106 includes at least one sensor, such as a plurality of sensors 122. In some embodiments, the plurality of sensors 122 are a plurality of fluid flow sensors, which sense the flow of the fluid from the tissue into the fluid absorption unit 104 and / or the flow of the fluid from the fluid absorption unit 104 into the control unit 106. In some embodiments, the plurality of sensors 122 sense the flow of the fluid from the control unit through the conduit 140 or the tube 134. Optionally, the plurality of sensors 122 sense the flow of the fluid through the pump 130. In some implementations, the plurality of sensors 122 include a plurality of fluid pressure sensors, which sense the pressure in the fluid flow path from the tissue to the fluid absorption unit 104 and / or the pressure in the fluid flow path from the fluid absorption unit 104 to the control unit 106. Optionally, the plurality of sensors 122 sense the pressure in the fluid flow path associated with the pump 130, before and / or after the pump 130.

[0263] According to some exemplary embodiments, the sensors 122 are a plurality of clinical sensors that sense at least one clinical parameter about the patient, such as blood pressure, interstitial pressure, levels of various substances in blood and / or urine, heart rate, body temperature, or any other clinical or physiological parameter about the patient. In some embodiments, the plurality of sensors 122 measure at least one parameter about the contents of the drained fluid and / or urine and / or blood, such as levels and / or concentrations of various chemical or biological molecules, such as electrolytes, creatinine, urea, albumin, and / or various synthetic drugs administered to the patient to treat a patient's symptoms.

[0264] According to some exemplary embodiments, the plurality of sensors transmit the plurality of sensed parameters to the control circuit 114. In some embodiments, the sensed data is retrieved from an independent and implantable or external device in communication with the control circuit 114. In some embodiments, the control circuit 114 stores at least some of the values ​​in the memory 116 of the control unit 106. In some implementations, the memory 116 stores a plurality of log files of the control unit 106 and / or the fluid absorption unit 104. In some embodiments, the memory 116 stores at least one treatment regimen and / or a plurality of values ​​of at least one treatment regimen. Optionally, the at least one treatment regimen or treatment parameter is about the activation of the pump 130, for example, the duration of activation, the number of intervals and the duration of intervals of multiple activation sessions of the pump 130, and / or the pump power of the pump 130.

[0265] According to some exemplary embodiments, the control unit 106 includes a communication 120. In some embodiments, the communication 120 is connected to the control circuit 114 and includes a wireless receiver and / or a wireless transmitter. In some embodiments, the communication 120 receives information from at least one external device or an external circuit located outside the body, such as a sensor, a computer, an external memory, a handheld device and / or a remote control. Alternatively or in addition, the communication 120 receives information from an implantable device located inside the body, such as a pacemaker and / or an implantable sensor. In some embodiments, the communication 120 transmits the received information to the control circuit 114.

[0266] According to some exemplary embodiments, the control circuit 114 sends a signal to the communication 120 to transmit information to a device or a circuit located outside the body, such as a sensor, a computer, an external memory, a handheld device and / or a remote control. In some embodiments, the control circuit 114 sends a signal to the communication 120 to transmit information to an external interface, such as a user interface located outside the body. In some embodiments, the control circuit sends a signal to the external interface to generate an alarm or multiple indications related to the treatment and / or activation of the implanted system and / or multiple measured clinical parameters. Alternatively or in addition, the communication transmits information to an implantable device located inside the body, such as a pacemaker and / or an implantable sensor.

[0267] According to some exemplary embodiments, the control unit 106 includes at least one battery 118 to provide power to various components of the control unit 106, such as the pump 130. In some embodiments, the battery 118 is a rechargeable battery or a replaceable battery.

[0268] According to some exemplary embodiments, a housing 142 of the control unit 106 is made of a biocompatible material and is optionally shaped and sized for subcutaneous implantation. In some embodiments, the housing 142 is positioned in a manner that allows replacement of certain components of the control unit 106, for example, to replace the battery 118 and / or the pump 130. In some embodiments, the housing 142 is flat, for example, to allow subcutaneous implantation.

[0269] According to some exemplary embodiments, a cuff 123 at least partially surrounds the outlet 124. In some embodiments, the cuff 123 is positioned between the control unit 106 and the fluid absorbent unit 104, the control unit 106 is positioned outside the peritoneum, and the fluid absorbent unit 104 is implanted inside the peritoneum. Alternatively, the fluid absorbent unit is implanted outside the peritoneum, for example, subcutaneously. In some embodiments, the shape and size of the cuff 123 is used to be placed in the opening of the peritoneum, and the opening of the peritoneum is opened during the insertion of the fluid absorbent unit into the abdominal cavity.

[0270] According to some exemplary embodiments, a damper 133 is in contact with the tube 134 and / or the pump 130. In some embodiments, the damper 133 dampens vibrations of the pump and / or pulsating fluid flowing through the tube 134. Optionally, the damper dampens the pulsating fluid flowing through the tube 134 and / or vibrations of the pump 130, thereby allowing measurement of the fluid flow and / or the contents of the fluid by the plurality of sensors 122.

[0271] According to some exemplary embodiments, the control circuit is connected to a timing circuit that sends a signal to the pump to activate the pump at a plurality of fixed duty cycles. In some embodiments, the control circuit sends a signal to the pump to cause the pump to operate intermittently at a fixed timing routine. Optionally, when a timing circuit is present, a memory is not present.

[0272] Exemplary System Interactions

[0273] According to some exemplary embodiments, the implanted system, such as implanted system 102, is part of a system for controlling and / or monitoring the drainage of the fluid from the body tissue. Figure 2A , which depicts a system interaction for draining fluid from a body tissue according to some embodiments of the present invention.

[0274] According to some exemplary embodiments, an implanted system 102 can optionally be connected to devices located outside the body via wireless connections. In some embodiments, the system 102 is connected to a specialist or a physician 204. In some embodiments, the device transmits indications and / or alerts to a physician, for example, when the system 102 is not functioning properly and / or when at least one result of the fluid drainage treatment is not a desired result. In some embodiments, the system 102 transmits treatment reports and / or device log files to the physician according to a selected schedule and / or upon request.

[0275] According to some exemplary embodiments, if the clinical condition of the patient changes, for example, when multiple values ​​of multiple clinical parameters measured by the device do not fall within an expected range of values, the system 102 transmits an indication to a physician 204. In some implementations, the physician transmits an updated treatment plan to the device, or changes at least one existing treatment plan or a treatment parameter stored in the memory of the system 102.

[0276] According to some exemplary embodiments, the implanted system 102 transmits multiple indications and / or alarms to the patient 206. In some embodiments, the system 102 transmits multiple indications and / or alarms if the device is not functioning properly and / or when multiple clinical parameters measured by the device do not fall within an expected range of values.

[0277] According to some exemplary embodiments, the system transmits multiple indications and / or alarms to a caregiver, such as a nurse 208. In some embodiments, the system 102 transmits multiple indications and / or alarms to the nurse 208 when the device is not functioning properly and / or when a component of the device needs to be replaced, for example, when an external bag for collecting the drained fluid is full and should be replaced. In some embodiments, the system 102 transmits an alarm to the nurse 208 and requires a visit to the patient.

[0278] According to some exemplary embodiments, the system 102 transmits a plurality of indications to a handheld device, such as the handheld device 212. In some embodiments, the handheld device 212 generates a human-detectable indication, such as an auditory indication and / or a visual indication. In some embodiments, the handheld device 212 transmits the human-detectable indication to the patient 206, and / or the physician 204, and / or the nurse 208. In some embodiments, the handheld device 212 is used to transmit information to the system 102 by using any input element of the handheld device 212.

[0279] According to some exemplary embodiments, the system 102 transmits information, such as multiple values ​​of clinical parameters and / or multiple log files of the device, to a remote server 210 or a remote computer. In some embodiments, the system 102 downloads information from the server 210, such as multiple changed treatment plans and / or multiple recommended treatments.

[0280] Exemplary flow of fluid between multiple compartments

[0281] According to some exemplary embodiments, fluid flows between different biological compartments in the body. Figure 2B , which depicts fluid flow between multiple biological compartments in vivo and / or between multiple biological compartments and an implantable fluid extraction lumen according to some embodiments of the present invention.

[0282] According to some exemplary embodiments, fluid from the lymphatic system, and / or intracellular fluid, and / or intravascular fluid enters the interstitial space at 220. In some embodiments, a membrane, such as a membrane of the fluid absorption unit 104, is directly in contact with the tissue to allow fluid from the tissue to enter the fluid absorption unit 104. In some embodiments, fluid from the tissue enters the fluid absorption unit 104 passively or actively, for example, when a pump connected to the fluid absorption unit 104 is activated. In addition, fluid from the interstitial space flows into the kidney at 227 and is optionally reabsorbed at 230.

[0283] According to some exemplary embodiments, fluid from the fluid absorbent unit 104 is transferred to the urethra, for example, via a catheter, for example, to the bladder at 226. Alternatively or additionally, fluid from the fluid absorbent unit 104 is transferred to a drainage bag, for example, via a catheter, at 224. In some embodiments, the drainage bag is located outside the body.

[0284] According to some exemplary embodiments, at 228, fluid from the urethra is excreted from the body in urine.

[0285] Exemplary Fluid Absorbent Units

[0286] According to some exemplary embodiments, in order to allow efficient direct extraction of fluid from a tissue, the tissue needs to be in close contact with, for example, a membrane of a fluid absorbent unit of a fluid extraction chamber. In some embodiments, the fluid extraction chamber maintains a semi-rigid structure that exerts a force on a portion of the tissue surface, for example, to reshape the tissue surface to conform to the outer surface of the fluid extraction chamber. Now referring to FIG. 3A to FIG. 3N , which depicts a fluid absorption unit, such as a fluid extraction chamber, according to some embodiments of the present invention.

[0287] According to some exemplary embodiments, for example, Figure 3A As shown, a fluid absorbent unit 300, such as a fluid extraction chamber, includes a bag, such as bag 306, and a tube 314, the tube 314 being connected to the bag 306 through a port 310, the port 310 being disposed at an opening of the bag 306. In some embodiments, a membrane is disposed on an exterior surface of the bag 306. Alternatively, the membrane is disposed within the bag 306.

[0288] According to some exemplary embodiments, an internal support, such as a spiral coil 312, is positioned within the bag 306. In some embodiments, the internal support exerts a force on an internal surface of the bag 306, for example, to maintain a semi-rigid structure of the fluid absorbent unit 300. In some embodiments, for example, when the external surface of the bag is in contact with the tissue, the semi-rigid structure of the bag 306 allows the external surface of a tissue to be reshaped. In some embodiments, the external surface of the tissue is reshaped to conform to the external surface of the bag 306.

[0289] According to some exemplary embodiments, a balloon 320 surrounds at least a portion of the tube 314 and is positioned in a peritoneal access opening.

[0290] According to some exemplary embodiments, for example, Figure 3B and Figure 3C As shown, the bag 306, which is optionally at least partially covered by a film, is preformed as a spiral template, into which the internal support is introduced, such as a spiral tube or the spiral coil 312. In some embodiments, the introduction of the spiral tube or the spiral coil 312 provides mechanical strength to the bag 306.

[0291] According to some exemplary embodiments, for example, Figure 3D and Figure 3EAs shown, an introduction tube 308 is connected to the bag 306. In some embodiments, the introduction tube 308 is connected to the bag 306 through the port 310. In some embodiments, the introduction tube 308 is used to introduce the bag 306 into the abdominal cavity through the peritoneal access opening.

[0292] According to some exemplary embodiments, for example, Figure 3F As shown, a connector 316 is partially positioned within an opening 304 of the spiral coil 312. In some embodiments, the tube 314 is connected to an end of the connector 316 that is located outside the spiral coil. In some embodiments, the tube 314 is connected to the connector 316 before the spiral coil is inserted into the body. Alternatively, the connector 316 includes an interlocking mechanism, for example, that allows the tube 314 to be connected to the connector when the spiral coil is in the body.

[0293] Now please refer to FIG. 3G to FIG. 3I , which depicts an internal support, such as a spiral coil within the bag, according to some embodiments of the present invention.

[0294] According to some exemplary embodiments, the internal support, such as the spiral coil 312, and the tube 314 are pushed into the bag 306 through the introduction tube 308. In some embodiments, the shape of the connector 306 is used to prevent the tube 314 from being inserted into the bag 306. In some embodiments, an outer diameter of the connector 316 is larger than an inner diameter of the port 310. Alternatively or additionally, for example, Figure 3F As shown, a distal section 315 of the tube 314 facing the connector 316 has a larger diameter than the diameter of the port 310. In some embodiments, the connector 316 can be optionally irreversibly interlocked with the port 310, for example, to prevent the spiral coil from being pulled out of the bag 306. In some embodiments, the connector 316 can be irreversibly interlocked with the port 310 using an interference locking mechanism, for example, a snap-fit ​​locking mechanism in the sensor 316 and / or the port 310. Alternatively, the connector 316 can be reversibly interlocked with the port 310, for example, by rotating the connector 316. Optionally, the connector 316 can be rotated by rotating the tube 314.

[0295] According to some exemplary embodiments, for example, Figure 3JAs shown, when the spiral coil 312 is positioned in the bag 306, the introduction tube 308 is separated from the port 310 and retracted. In some embodiments, the lock between the connector 316 and the port 310 is stronger than the lock between the introduction tube 308 and the port 310. Alternatively, the introduction tube 308 is separated from the port 310 by rotating the introduction tube clockwise or counterclockwise. In some embodiments, the introduction tube is rotated in a direction opposite to the rotation required to lock the spiral coil 312 in the bag 306, for example, by interlocking the connector 316 with the port 310.

[0296] Now please refer to Figure 3K and 3L , which depicts an internal spiral support according to some embodiments of the present invention. According to some exemplary embodiments, the internal support, such as spiral coil 312, is a tubular structure having an inner cavity 322. In some embodiments, the tubular structure contains a plurality of openings connected between the outer surface of the spiral coil and the inner cavity 322. In some embodiments, the fluid in the bag penetrates the plurality of openings in the spiral coil into the inner cavity. In some embodiments, the inner cavity of the spiral coil guides the fluid to leave the bag.

[0297] According to some exemplary embodiments, the internal support, such as the spiral coil 312, is used to provide mechanical strength and is unable to direct fluid through an inner cavity to exit the bag. In some embodiments, the internal support, such as the spiral coil 312, includes a plurality of voids, such as the voids 324 on the outer surface of the internal support, to allow fluid to flow freely into the bag. In some embodiments, the fluid exits the bag through an opening in the bag, such as the port 310 connected to a drain such as the tube 314.

[0298] According to some exemplary embodiments, for example, Figure 3MAs shown, a fluid absorbent unit comprises a bag 330, which optionally has an outer cover film 332 and an inner support layer 334. In some embodiments, the cover film 332 is a porous film that allows fluid to enter the capsule 330. In some embodiments, the plurality of pores in the film 332 are small enough not to allow cells to penetrate into the capsule. In some embodiments, the size of the plurality of pores, such as the width of the plurality of pores or the largest dimension of the plurality of pores, is less than 10 microns, such as 9 microns, 8 microns, 7 microns, 0.5 microns, 0.45 microns, 0.25 microns, or any intermediate or smaller size. Alternatively, the size of the plurality of pores is 10 microns or larger, such as 10 microns, 11 microns, 12 microns, or any intermediate or larger size.

[0299] According to some exemplary embodiments, the shape and size of the inner support layer 334 is used to isolate the outer cover membrane 332 from an internal support located in the bag 330. In some embodiments, the inner support layer is made of a fabric, optionally an elastic fabric, or made of a non-woven sheet. In some embodiments, the elastic fabric is strong enough to resist the force applied by the internal support inserted into the bag, or any pressure applied from the inside of the bag toward the membrane, and resist the collapse of the cover layer 334 (membrane) and pressure from various biological tissues. In some embodiments, the support layer 334 is porous, for example, to allow fluid to penetrate the cover layer into the bag 330. In some embodiments, the support layer 334 is a surface treated with ionically charged groups, for example, to increase a driving penetration force and / or to affect the penetration of certain components of the extracted fluid.

[0300] According to some exemplary embodiments, the bag 330 includes at least one opening. In some embodiments, a port, such as port 336, is placed in the opening. In some embodiments, a distal header of an internal support, such as braided tube 338, is shaped to facilitate insertion into the bag 330 through the port 336. In some embodiments, an outer diameter of the braided tube 338 is smaller than an inner diameter of the port 336. In some embodiments, the diameter of the braided tube is in a range of 2 to 8 mm, such as 2, 3, 4, 5, 6, 7, 8 mm, or any intermediate value. In some embodiments, the diameter of the port 336 is in a range of 3 to 9 mm, such as 3, 4, 5, 6, 7, 8, 9 mm, or any intermediate value. In some embodiments, the braided tube 338 includes an internal stylet 340, which can be optionally made of a shape memory material, such as nickel titanium alloy. In some embodiments, the shape of the internal stylet is used to maintain the braided tube 338 flat when the braided tube 338 is introduced and positioned within the bag 330.

[0301] According to some exemplary embodiments, the inner support includes a connector 342, which is positioned in a proximal region of the braided tube 338. In some embodiments, the connector 342 at least partially or completely surrounds the braided tube 338. In some embodiments, once the braided tube 338 is pushed into the bag 330, the connector 342 is locked to the port 336. In some embodiments, the connector is optionally irreversibly interlocked with the port 336. Alternatively, the connector 342 is reversibly interlocked with the port 336. In some embodiments, the connector 342 is interlocked with the port 336 by rotation of the connector 342 or by rotation of a drain tube 342 connected to the connector 342. Alternatively, the connector 342 is interlocked with the port 336 by applying a force to the port 336. In some embodiments, the connector 342 is sealingly locked into the port 336, optionally by radially pressing on a closed O-ring seal. In some embodiments, the connector 342 can be selectively sealed and locked into the port 336 by radially pressing on the closed O-ring seal when a reasonably large force of several Newtons is applied, allowing a snap-fit ​​option. In some embodiments, snap-fit ​​or release can only be performed by introducing a designated tool.

[0302] According to some exemplary embodiments, the mouthpiece 340 has a rectangular or circular cross-section. In some embodiments, for example, as shown in a cross-sectional view 351, the mouthpiece 340 is placed and extends along a tube 350, such as a silicone tube. In some embodiments, the silicone tube is wrapped by an outer braided layer. Alternatively, for example, as shown in a cross-sectional view 353, the mouthpiece 340, optionally a mouthpiece having a rectangular cross-section, is placed in and extends along a tube 356, such as a silicone tube. In some embodiments, the tube is wrapped by an outer coil.

[0303] According to some exemplary embodiments, the stylet 340 is memory-formed into the spiral flat form required for the absorption cavity 330. In some embodiments, the stylet comprises a plurality of mandrels having different cross-sections to best provide a spiral shape having similar stiffness or hardness. Optionally, a plurality of smaller cross-sectional areas are located at a distal (pointed) end portion of the stylet, while a plurality of larger cross-sectional areas are located at a proximal end portion of the stylet. In some embodiments, the stylet 340 is conical, and the size or radius of its cross-section varies continuously. In some embodiments, the stylet 340 is made of a material that is harder than the covering layer, for example, nickel-titanium alloy, stainless steel, cobalt-chromium alloy, or a variety of polymers, or any combination of these materials.

[0304] Now please refer to Figure 3N , which depicts multiple components of a fluid absorption when introduced into the peritoneum according to some embodiments of the present invention.

[0305] According to some exemplary embodiments, a guide tube 360 ​​includes an internal thread 359 at a distal end of the tube or a plurality of protruding gripping features that conform to a plurality of mating grooves of the port 336. In some embodiments, the port of the bag is connected to the internal thread 359. In some embodiments, a releaser, such as releaser 364, includes a rectangular end 362 having a rectangular cross-section. Alternatively or in addition, the releaser 364 includes a plurality of gripping features that closely conform to a plurality of corresponding grooves located on the inner surface of the port 336. In some embodiments, the rectangular end 362 conforms to an inner shape of the guide tube 360. In some embodiments, in order to release the guide tube 360 ​​from the port of the bag, the rectangular end 362 of the releaser 364 is inserted into a proximal end 361 of the guide tube 360. Optionally, the release 364 is embedded in the guide tube 360, which is sealed at its proximal end, for example, to prevent gas leakage. In some embodiments, once the release 364 is at least partially located in the guide tube 360, the release is rotated clockwise or counterclockwise, or pushed, or pulled to release the port from the internal threads 359 of the guide tube 360. In some embodiments, the release 360 ​​allows the release of the braided tube 338 in order to retract the braided tube 338 and / or the entire cavity.

[0306] According to some exemplary embodiments, after a braided coil 366, which may be optionally preformed to obtain a spiral structure, is introduced into the bag, the guide tube 360 ​​is released from the port of the bag. Alternatively or additionally, as previously described, the guide tube 360 ​​is released from the port when a connector 368 located in the proximal end of the braided coil 366 interlocks with the port. In some embodiments, a drain tube 370 is connected to an opposite side of the connector 368.

[0307] According to some exemplary embodiments, the braided coil 366 is pushed into the bag by a pusher or a mandrel 372, which is optionally connected to the drain tube 370 or the connector 368. In some embodiments, the braided coil 366 is pushed into the bag by rotating or turning the mandrel 372 clockwise or counterclockwise.

[0308] According to some exemplary embodiments, for example, Figure 3NAs shown, during the deployment process of the fluid absorbent unit, the bag 376 is folded around or inside the introduction tube 360. In some embodiments, for example, as shown in a cross-sectional view 377, an internal needle wire 361 is inserted into or outside the bag 376 to improve the execution of deployment. In some embodiments, during the deployment process, the bag 376 in the folded state is covered by a cover sleeve 378. In some embodiments, the cover sleeve 378 prevents the membrane from contacting various tissues during the deployment process and / or provides sufficient rigidity or sufficient stiffness to slide through a laparoscopic introducer or other guide tool. Additionally or alternatively, the cover sleeve 378 prevents the bag 376 from expanding unnecessarily during the deployment process. In some embodiments, a diameter of the cover sleeve 378 is less than a diameter of the peritoneal opening. In some embodiments, the cover sleeve 378 is large enough to retain the folded bag 376. In some implementations, the inner diameter of the sleeve is in a range of 6 to 14 mm, such as 6, 7, 8, 10 mm, or any intermediate or greater value. In some embodiments, the thickness of the cover sleeve 378 is in a range of 0.05 to 1 mm. In some embodiments, the cover sleeve is long enough to be pulled out of the body. In some embodiments, the cover sleeve 378 is made of a surface treated smooth or hydrophobic polymer. Alternatively, the cover sleeve 378 is made of an absorbable material and / or a soluble material.

[0309] According to some exemplary embodiments, the cover liner 376 is clamped onto the edge of the bag 378, for example, to assist in the unfolding of the bag, and optionally is pushed back relative to the bag and reveals the bag.

[0310] According to some exemplary embodiments, for example, FIG. 4A to FIG. 4C As shown, a fluid absorption unit 402, such as a fluid extraction chamber, includes a membrane encasing a chamber 404. In some embodiments, the chamber 404 encased by the membrane includes an outlet connector 412, which is similar to the port 310. In some embodiments, the chamber 402 encased by the membrane is in the shape of a disk and includes a contour seal 406 on a circumference of the chamber. In some embodiments, the contour seal 406 seals a junction of two membranes on opposite sides of the disk-shaped chamber 402.

[0311] According to some exemplary embodiments, a drainage tube 401 comprises a plurality of sub-muscular suturing leaflets 410 to anchor the drainage tube in the body, such as in the abdominal cavity, and optionally in the peritoneum. In some embodiments, at least one fixing band 408 is wrapped around the drainage tube, for example, to fix the position of the drainage tube 401 in the peritoneal inlet and outlet.

[0312] According to some exemplary embodiments, for example, Figure 4B and Figure 4C As shown, when a helical braided tube 414 is placed within a circular cavity, such as the cavity 404 enclosed by the membrane, the helical braided tube 414 is preformed to form a helical shape.

[0313] Example deployment of an implanted system

[0314] Now please refer to FIG. 5A to FIG. 5G , which depicts deployment of an implanted system according to some embodiments of the present invention.

[0315] According to some exemplary embodiments, for example, Figure 5A As shown, an opening is made in the body wall and the peritoneum. In some embodiments, a bag 508 in a folded state is wrapped around an introduction tube 504. In some embodiments, for example, Figure 5B As shown, the introduction tube 504 is advanced into the peritoneum through a peritoneal port 502 .

[0316] According to some exemplary embodiments, for example, Figure 5C As shown, the bag 508 is deployed within the peritoneum. Figure 5D As shown, a braided tube 512 is advanced into the deployed bag 508 through the introduction tube 504, for example, to stabilize the bag 510 in a deployed state.

[0317] According to some exemplary embodiments, for example, Figure 5EAs shown, the introduction tube is retracted when the bag 508 is stabilized in an expanded state. In some embodiments, a drainage tube 507 connected to the bag 508 includes a cuff 505, which is positioned in an opening in the peritoneum. In some embodiments, a control unit 514 is implanted outside the peritoneum, and optionally subcutaneously. In some embodiments, the drainage tube 507 is connected to the control unit 514, and optionally to a pump placed in the control unit 514. In some embodiments, the control unit is connected to the urinary system, optionally to the bladder 518, through a drainage catheter 516, such as a pigtail catheter.

[0318] According to some exemplary embodiments, for example, Fig. 5F As shown, the control unit 514 is connected to the renal pelvis 515 via the pigtail catheter.

[0319] According to some exemplary embodiments, for example, Figure 5G As shown, the bag 508 is introduced and deployed in the peritoneum using a laparoscope, which visualizes the introduction and positioning of the bag 508. In some embodiments, the bag is deployed and positioned within the peritoneum without the use of any anchors.

[0320] Now please refer to Figure 6 , which depicts a process for deploying an implantable device according to some embodiments of the present invention.

[0321] According to some exemplary embodiments, at 602, a catheter having a folded bag is introduced into the peritoneum. In some embodiments, the folded bag is wrapped around an introduction tube. In some embodiments, the folded bag is enclosed in a chamber of a tube, such as an introduction tube. Optionally, during the insertion phase into the peritoneum, the folded bag is covered by an outer layer or an outer sheet that protects the bag, the outer layer or outer sheet being optionally covered by a membrane. Alternatively or additionally, the outer layer or the outer sheet covering the folded bag prevents the bag from unfolding.

[0322] According to some exemplary embodiments, at 604, the bag is deployed. In some embodiments, the bag is deployed when the bag is in a desired position within the peritoneum. In some embodiments, the bag is deployed by retracting a layer or a cover or an envelope covering the bag. In some embodiments, a tube covering the bag is retracted during insertion of the bag into the peritoneum, for example, to allow the bag to be deployed.

[0323] According to some exemplary embodiments, at 606, an internal support or an internal skeleton is inserted into the inner cavity of the unfolded bag. In some embodiments, the internal support, such as a braided tube or a coiled tube, is inserted by rotating the internal support. In some embodiments, the rotation of the internal support causes the internal support to move forward into the bag. Alternatively, the internal support is pushed into the bag. In some embodiments, when the internal support is positioned in a desired position and / or pushed into the bag at a desired length, a locking mechanism is activated, for example, to prevent the internal support from leaving the bag. In some embodiments, the internal support is locked into the bag by rotating the internal support or by pushing the internal support. In some embodiments, the internal support is reversibly or irreversibly locked or fixed into the bag.

[0324] According to some exemplary embodiments, at 608, a control device is implanted. In some embodiments, the control device is implanted extraperitoneally. Optionally, the control device is implanted subcutaneously. In some embodiments, the control device is implanted in a pocket or anchored to a tissue.

[0325] According to some exemplary embodiments, at 610, the bag is connected to the control device. In some embodiments, the bag is fluidly connected to the control device via a tube, such as a drain tube. In some embodiments, the drain tube is connected to the inner support located inside the bag. Optionally, the drain tube is the inner support, such as a different area of ​​the inner support.

[0326] According to some exemplary embodiments, at 612, a drainage conduit is connected to the control device. In some embodiments, the drainage conduit is fluidly connected to a pump located within the control device. In some embodiments, a first opening of the drainage conduit is fluidly connected to the control device. In some embodiments, a second opening of the drainage conduit is placed in the urinary system, such as in the kidney or in the bladder.

[0327] Exemplary bag filled with beads

[0328] Now please refer to Fig. 7A , which depicts a bag filled with beads according to some embodiments of the present invention.

[0329] According to some exemplary embodiments, a bag, such as bag 700, is covered by a membrane, such as a membrane 702. In some embodiments, a filling tube, such as filling tube 706, is connected to an opening in the bag 700, and the filling tube is used to fill the bag 700 with a plurality of beads. In some embodiments, the plurality of beads provide mechanical strength to the bag 700, for example, to maintain an outer surface of the bag 700 flat and optionally semi-rigid. In some embodiments, the plurality of beads maintain a non-collapsed inner bag volume. Alternatively or in addition, the plurality of beads are ionically charged, for example, to induce an osmotic pressure that draws fluid from the tissue into the bag 700. In some embodiments, the osmotic pressure is induced by the plurality of beads in addition to applying an active vacuum force by a pump connected to the bag. Alternatively, the osmotic pressure is induced by the plurality of beads rather than the vacuum force. In some embodiments, the size of the plurality of beads is in a range of 0.5 to 3 mm, such as 0.5, 1, 2, 3 mm or any intermediate value. In some embodiments, a smallest dimension of the plurality of beads is at least 0.5 mm, such as 0.5, 1, 1.5 mm, or any intermediate or larger value.

[0330] In some embodiments, the plurality of beads are spherical or ellipsoidal beads. In some embodiments, the plurality of beads are semi-porous and / or drilled. In some embodiments, the plurality of beads comprise a hard outer surface, for example, to increase the overall permeability of the contact area of ​​the membrane 702.

[0331] According to some exemplary embodiments, the bag 700 is shaped as a disk having two flat surfaces. In some embodiments, the bag comprises at least two openings on the plurality of flat surfaces, the at least two openings allowing fluid to pass through the plurality of flat surfaces without entering the chamber of the bag. In some embodiments, the openings, such as opening 704, are formed by connecting a plurality of inner sides of the two flat surfaces at different locations. In some embodiments, the plurality of inner sides connecting the plurality of flat surfaces restricts the movement of the plurality of beads within the chamber of the bag 700. Optionally, restricting the movement of the plurality of beads forces the plurality of beads to be evenly distributed within the chamber of the bag 700. In some embodiments, the even distribution of the plurality of beads allows the plurality of beads to apply a uniform mechanical force on an interior surface of the bag 700 along the entire interior surface. Additionally or alternatively, the even distribution of the plurality of beads, such as a plurality of charged beads within the bag, allows a uniform osmotic pressure to be applied along the entire surface of the bag 700.

[0332] Now please refer to Figure 7B, which depicts a process for deploying a bag filled with a plurality of beads according to some embodiments of the present invention.

[0333] According to some exemplary embodiments, a catheter and a folded balloon or a folded bag are introduced into the peritoneum at 708. In some embodiments, during the introduction phase, the folded balloon is covered by a layer or a sheet, for example, to prevent folding of the balloon and / or separation of the balloon from body tissue during the introduction phase, for example, as Figure 6 In some embodiments, the balloon is covered with a film.

[0334] According to some exemplary embodiments, at 710, the balloon is deployed. In some embodiments, the balloon is deployed when the balloon is positioned at a desired location within the peritoneum. In some embodiments, the balloon is deployed by removing a covering or layer covering the balloon. Alternatively or selectively, the balloon is deployed by retracting a tube covering the balloon.

[0335] According to some exemplary embodiments, a filling tube is connected to the balloon at 712. In some embodiments, a filling tube is connected to a proximal opening of an introduction tube, which is connected to an opening of the bag. Alternatively, the filling tube is pushed into the balloon within the introduction tube.

[0336] According to some exemplary embodiments, the balloon is filled with a plurality of beads at 714. In some embodiments, the plurality of beads are pushed into the balloon through the filling tube, optionally with force applied through an opening of the filling tube placed extraperitoneally.

[0337] According to some exemplary embodiments, at 716, the balloon filled with the plurality of beads, such as a bag filled with the plurality of beads, is at least partially sealed. In some embodiments, the bag filled with the plurality of beads is at least partially sealed to prevent the plurality of beads from being released from the bag. In some embodiments, the balloon filled with the plurality of beads is partially sealed by placing a mesh in an opening of the balloon having a plurality of holes, the plurality of holes being smaller than the size of the plurality of beads. Alternatively, the filling tube or an opening in the bag used to fill the plurality of beads is sealed.

[0338] According to some exemplary embodiments, at 610, once the plurality of beads cannot be released from the bag, the bag is connected to a control device, such as Figure 6 described.

[0339] In some embodiments, the plurality of beads are manufactured to have a high porosity, such as a porosity greater than 1000 kilodaltons (kDa). In some embodiments, the porosity is greater than 65 kDa, such as greater than 80, 10, 120 kDa, or any intermediate or smaller or larger value. In some embodiments, the porosity of the plurality of beads is greater than the size of albumin. In some embodiments, the plurality of beads are manufactured to have a specific polarity, charge, size exclusion and / or affinity. In some embodiments, for a relatively large cavity of 160 mm in diameter and 6 mm in thickness, a drilled sphere of 2.5 mm in diameter is used, such as using polypropylene material (0.9 g / cm3), resulting in 120 beads in the bag weighing 72 g.

[0340] Exemplary colloid-filled cavity

[0341] Now please refer to Fig. 8A , which according to some embodiments of the present invention describes a cavity having a skeleton filled with a colloid.

[0342] According to some exemplary embodiments, a cavity, such as cavity 802, comprises an internal skeleton covered by a membrane, such as membrane 804. In some embodiments, the internal skeleton comprises a central tubular ring 803 having at least one tubular rib extending from the central tubular ring 803. Alternatively, the internal skeleton comprises an outer tubular ring 805 surrounding the periphery of the cavity 802 and having at least one tubular rib 806 extending from the outer tubular ring 805. In some embodiments, the at least one tubular rib is in contact with the central ring and the outer ring. In some embodiments, the at least one tubular rib is in fluid connection with the outer tubular ring 805 and / or with the central tubular ring 803.

[0343] According to some exemplary embodiments, a filling tube 810 is connected to the central tubular ring 803 and / or to the outer tubular ring 805 and / or to the tubular ring 806 fluid of the inner support. In some embodiments, the inner support is filled with a colloid or a polymerizing fluid, optionally a self-polymerizing fluid or a hydrogel or a viscous fluid, such as saline with added sucrose. In some embodiments, after the colloid or the self-polymerizing fluid is inserted, the filling opening in the cavity is sealed. In some embodiments, the fluid entering the cavity 802 circulates freely between the multiple internal support elements without contacting the colloid or the self-polymerizing fluid. In some embodiments, the fluid entering the cavity 802 through the membrane 804 is discharged from the cavity via a drain tube 810, which is connected to an opening in the cavity 802.

[0344] Now please refer to Figure 8B , which depicts a process for deploying a cavity filled with a colloid, according to some embodiments of the present invention.

[0345] According to some exemplary embodiments, a cavity, such as a balloon cavity, is expanded, such as Figure 7B In some embodiments, at 814, a colloid or a polymeric fluid is filled into the cavity. In some embodiments, the colloid is filled into an internal skeleton of the cavity through a filling tube. In some embodiments, the colloid in the internal skeleton is isolated from the fluid entering the cavity, for example, the fluid extracted from a tissue.

[0346] According to some exemplary embodiments, the colloid-filled tube is sealed at 816. When a desired amount of colloid or self-polymerizing fluid is inserted into the cavity, the colloid-filled tube is sealed.

[0347] According to some exemplary embodiments, the cavity is anchored at 818. In some embodiments, the cavity is anchored after the internal skeleton reaches a desired stiffness or a desired internal force is applied to the external surface of the cavity. In some embodiments, the cavity is anchored by at least one anchor located on the external surface of the cavity.

[0348] According to some exemplary embodiments, at 820, a colloid or fluid is filled. In some embodiments, the colloid or fluid is filled into the cavity, optionally through a dedicated filling port. In some embodiments, the dedicated filling port is coaxially and / or intracavitarily positioned on the drainage tube.

[0349] According to some exemplary embodiments, once the drain port is opened, the chamber is connected to a control unit, for example Figure 6 As described in 610.

[0350] Exemplary Removal and / or Replacement of Various Components of the System

[0351] According to some exemplary embodiments, if an abdominal extraction is desired, the filler (helical braided tube or coil, multiple beads or a non-polymeric colloid) of the bag is first removed. In some embodiments, after the removal of the filler, the bag loses its relative rigidity or stiffness, and the bag can be folded and manipulated to allow a small incision / port for extraction. In some embodiments, after the removal of the filler, the membrane bag is left in its original position.

[0352] Several exemplary sources of input that influence treatment

[0353] Now please refer to Fig. 9A , which depicts multiple parameters that affect a fluid filtration therapy according to some embodiments of the present invention.

[0354] According to some exemplary embodiments, a fluid filtration therapy 900 is influenced by a plurality of clinical parameters 902 of the patient. In some embodiments, at least one therapy parameter is adjusted to suit the clinical condition of the patient. In some embodiments, the clinical parameter is determined based on the patient's physiological condition and / or based on a plurality of test results and a plurality of measurements of the plurality of clinical parameters. In some embodiments, the therapy is adapted to a plurality of selected patients, such as warm and wet patients.

[0355] According to some exemplary embodiments, the therapy 900 is affected by the contents of the drained fluid 904. In some embodiments, at least one parameter of the therapy is varied based on the levels of various chemical and / or biological components in the drained fluid.

[0356] According to some exemplary embodiments, the therapy 900 is affected by the system state 906. In some embodiments, at least one parameter of the therapy is changed following changes in the system state, for example, an error or a malfunction in at least one component of the system. In some embodiments, the therapy is stopped or changed when a fluid absorption unit and / or a fluid flow path of the system is blocked. In some embodiments, the therapy is changed, for example, to allow replacement of at least one component of the implanted system.

[0357] According to some exemplary embodiments, the therapy 900 is altered upon receiving input from other device 908. In some embodiments, at least one parameter of the therapy 900 is altered upon receiving input from a plurality of sensors and / or a plurality of devices, optionally a plurality of implanted sensors and devices in communication with a control unit, such as control unit 106.

[0358] According to some exemplary embodiments, the therapy 900 is influenced by an expert input 910. In some embodiments, an expert, such as a physician, selectively changes a therapy from a remote computer based on multiple instructions received from the patient and / or the device. In some embodiments, the physician changes the therapy after the patient's condition improves or worsens.

[0359] According to some exemplary embodiments, the therapy is affected by a patient input 912. In some embodiments, the patient input 912 includes the patient's compliance with the therapy, for example, whether the patient follows multiple therapy instructions. In some embodiments, the patient input 912 includes body posture and position. Optionally, the patient input 912 includes the patient's food and water consumption, for example, the amount of water the patient drinks in a selected time.

[0360] Several exemplary input types that affect therapy

[0361] Now please refer to Fig. 9B , which depicts multiple input types that affect the fluid withdrawal therapy according to some embodiments of the present invention.

[0362] According to some exemplary embodiments, a fluid withdrawal therapy 900 is affected by a plurality of clinical parameters 901. In some embodiments, the therapy or at least one therapy parameter is changed based on the plurality of clinical parameters 901. Optionally, a different therapy plan is selected based on the plurality of measured clinical parameters 901. In some embodiments, the plurality of clinical parameters include weight, such as measured by the patient, blood pressure and / or heart rate. In some embodiments, the plurality of clinical parameters 901 include a plurality of parameters regarding the patient's level of congestion, such as a plurality of parameters regarding pulmonary congestion, orthopnoea, paroxysmal nocturnal dyspnea, peripheral (bilateral) edema, jugular venous distension, congestive hepatomegaly, gastrointestinal congestion, ascites and / or hepatojugular reflux. In some embodiments, the plurality of clinical parameters 901 include a plurality of parameters regarding the patient's level of hypoperfusion, such as a plurality of parameters regarding cold extremities, oliguria, confusion, dizziness and / or narrow pulse pressure. In some embodiments, the clinical parameters are measured as an absolute value or as a value relative to a reference value or a baseline value.

[0363] According to some exemplary embodiments, a fluid withdrawal therapy is affected by a sensory data 903. In some embodiments, the sensory data 903 includes data received by sensing the patient's body, for example, how hot or cold the patient is, how sweaty the patient's skin is, and / or by sensing the swelling of the patient's legs after edema.

[0364] According to some exemplary embodiments, a fluid extraction therapy 900 is affected by behavioral data 905. In some embodiments, the behavioral data 905 includes data about body movements and / or body postures. In some embodiments, the behavioral data 905 includes data about eating and drinking.

[0365] According to some exemplary embodiments, a fluid extraction therapy 900 is subject to multiple alarms 907, for example, multiple alarms generated by an implanted system for extracting fluid. In some embodiments, the multiple alarms 907 include multiple alarms regarding the status of the device, such as malfunction alarms. In some embodiments, the multiple alarms 907 include multiple alarms regarding a result of the treatment, for example, when a result of the treatment is not a desired result. In some embodiments, the multiple alarms 907 include multiple alarms regarding compliance with the treatment, for example, when a patient behaves in a manner that does not follow a selected treatment plan.

[0366] According to some exemplary embodiments, a fluid extraction therapy 900 is affected by multiple protocol adjustments 909. In some embodiments, the multiple protocol adjustments 909 include multiple adjustments regarding activation of a pump of an implantable fluid extraction device, such as the level of vacuum force applied, the duration of activation of the pump, and / or the duration of multiple duty cycles.

[0367] Exemplary General Process for Changing a Therapy

[0368] Now please refer to Fig. 9C , which depicts a general process for changing a fluid withdrawal therapy according to some embodiments of the present invention.

[0369] According to some exemplary embodiments, at 920, patients are selected. In some embodiments, multiple patients suitable for the treatment are selected based on the clinical conditions of the multiple patients. In some embodiments, multiple patients with acute heart failure are selected based on the hemodynamics and congestion conditions of the multiple patients, optionally with a known chronic background. In some embodiments, at 920, patients are selected based on the congestion level and / or based on the low perfusion level of the multiple patients. In some embodiments, the congestion level and / or the low perfusion level indicate the hemodynamic conditions of the multiple patients. In some embodiments, patients diagnosed with low congestion and without low perfusion levels are referred to as warm-dry (WARM-DRY) patients. In some embodiments, patients diagnosed with high congestion levels and without or with low low perfusion levels are referred to as warm-wet (WARM-WET) patients. In some embodiments, patients diagnosed with low congestion levels and high low perfusion levels are referred to as cold-dry (COLD-DRY) patients. In some embodiments, patients diagnosed with high congestion levels and high low perfusion levels are referred to as cold-wet (COLD-WET) patients.

[0370] In some embodiments, warm-wet patients and / or cold-wet patients are selected.

[0371] According to some exemplary embodiments, at 922, a treatment is determined. In some embodiments, a treatment is determined based on the multiple clinical conditions of the patient. Alternatively, a parameter value of at least one treatment is determined based on the multiple clinical conditions of the patient. In some embodiments, a treatment is determined based on a clinical classification of the patient, such as a warm-wet category or a cold-wet category.

[0372] According to some exemplary embodiments, the treatment is started at 924. In some embodiments, the treatment is started after measuring baseline values ​​or reference values ​​for a plurality of clinical parameters for the patient.

[0373] According to some exemplary embodiments, at 926, one or more parameters are measured. In some embodiments, the plurality of measured parameters include a plurality of clinical parameters, a plurality of behavioral parameters, a plurality of psychiatric parameters, a plurality of sensory parameters, and / or a plurality of parameters related to treatment. In some embodiments, at 926, congestion or a congestion-proxy is measured. Optionally, the congestion or congestion-proxy of the interstitial fluid or the extracted fluid is measured.

[0374] According to some exemplary embodiments, at 928, input is received. In some embodiments, the input is received from a patient, a caregiver, or a physician. Optionally, the input is received after an analysis of the plurality of measured parameters.

[0375] According to some exemplary embodiments, at 930, the therapy is changed. In some embodiments, the therapy or at least one therapy parameter is adjusted based on the plurality of measured parameters and / or based on the received input. In some embodiments, the duration of the therapy and / or the force applied by a pump of the implanted system is changed. In some embodiments, the therapy and / or at least one therapy parameter is changed to adjust the therapy to a new clinical condition of the patient.

[0376] According to some exemplary embodiments, at 930, the pressure applied to the tissue and / or the plurality of duty cycles of the pump are varied, for example, to assess the recovery time of the interstitial pressure during treatment. In some embodiments, at 930, the pressure applied to the tissue and / or the plurality of duty cycles of the pump are varied, for example, to adjust the treatment to the recovery rate of the interstitial pressure.

[0377] Exemplary process for changing a therapy based on multiple clinical measurements

[0378] According to some exemplary embodiments, for example in patients with vascular congestion, the system is coupled to an intravascular pressure monitor as a surrogate marker for venous congestion and will operate until the venous filling pressure is reduced to normal values, or to a desired range of values.

[0379] According to some exemplary embodiments, for example, in patients with systemic volume overload, the system monitors the impedance water assessment, body weight, and the internal congestion surrogate marker. In some embodiments, the system is adjusted to operate slower in patients with vascular congestion than in patients with systemic volume overload.

[0380] According to some exemplary embodiments, in multiple subjects suffering from the following conditions: (1) left-sided heart failure and underlying chronic kidney disease; (2) right-sided heart failure, excluding symptoms of ascites; (3) biventricular heart failure; (4) Fontanel failure; and (5) pulmonary hypertension with systemic congestion, the fluid withdrawal therapy using the systems and methods described herein is adjusted to withdraw fluid in the range of 150 to 500 ml per day.

[0381] According to some exemplary embodiments, in multiple subjects suffering from the following conditions: (1) stage IV and stage V chronic kidney disease; (2) end-stage renal disease; (3) abdominal compartment syndrome; (4) ascites symptoms associated with cirrhosis, portal hypertension, etc., the fluid extraction therapy using the systems and methods described herein will be adjusted to extract fluid in the range of 500 to 1000 ml per day.

[0382] According to some embodiments, a predetermined therapy is altered, optionally automatically, based on a plurality of measurements of a plurality of clinical parameters taken during the therapy. Fig.9D , which describes a process for varying a fluid withdrawal therapy in response to multiple measurements of multiple clinical parameters, according to some embodiments of the present invention.

[0383] According to some exemplary embodiments, at 932, a plurality of clinical parameters. In some embodiments, a plurality of clinical parameters, such as Fig. 9B The displayed clinical parameters 901 are measured during the treatment. Optionally, the clinical parameters are automatically measured by at least one sensor, such as a plurality of sensors 122. Alternatively or additionally, the clinical parameters are measured by the patient, such as weight, or blood pressure of the patient, or by an external sensor wirelessly connected to the device.

[0384] According to some exemplary embodiments, at 934, a condition of the patient is diagnosed. In some embodiments, the condition of the patient is diagnosed based on the plurality of measured clinical parameters. In some embodiments, at 934, a hemodynamic condition of the patient is determined based on the plurality of measured clinical parameters. In some embodiments, at 934, a clinical condition related to the urinary system, such as a kidney condition, and / or a heart condition, and / or a blood condition, is diagnosed. In some embodiments, at 934, a clinical condition related to fluid movement between multiple biological compartments, such as between blood and cells, and / or between blood and the urinary system is diagnosed.

[0385] According to some exemplary embodiments, a clinical condition of the patient is staged at 936. In some embodiments, the clinical condition, such as a disease or a pathological condition, is staged at 936. Optionally, the clinical condition of the patient is staged based on the plurality of measured clinical parameters or any other measured parameters.

[0386] According to some exemplary embodiments, at 930, the treatment is changed. In some embodiments, at 932, the treatment and / or at least one treatment parameter is changed based on the measurement of the plurality of clinical parameters. Alternatively or additionally, the treatment and / or at least one treatment parameter is changed based on the diagnosis of the clinical condition at 934, and / or based on the staging of the clinical condition at 936. In some embodiments, the treatment and / or at least one treatment parameter is changed to adjust the treatment to a new clinical condition of the patient.

[0387] Exemplary process for changing a therapy based on multiple measurements of the extracted fluid

[0388] According to some embodiments, a predetermined therapy is altered, optionally automatically, based on a plurality of measurements of the expelled fluid taken during the therapy. Fig.9E , which describes a process for varying a fluid extraction therapy in accordance with multiple measurements of the extracted fluid, according to some embodiments of the present invention.

[0389] According to some exemplary embodiments, at 940, the extracted fluid is measured. In some embodiments, at 940, the contents of the extracted fluid are measured. In some embodiments, the levels of multiple chemical substances, multiple minerals, and multiple biological agents, such as antibodies, proteins, vitamins, acids, are measured in the extracted fluid. In some embodiments, the multiple measured substances include sodium levels, potassium levels, creatinine levels, albumin levels, urea levels, or levels of other biomarkers, such as brain natriuretic peptide (BNP). In some embodiments, the concentrations of the multiple measured substances are determined. Optionally, the levels of the multiple measured substances are compared with a reference value or a baseline value. In some embodiments, the levels of the multiple measured substances are compared with the levels of multiple substances in the blood.

[0390] According to some exemplary embodiments, at 942, a condition of the patient is diagnosed based on the multiple measurements of the extracted fluid. In some embodiments, at 942, a hemodynamic condition of the patient is determined based on the multiple measurements of the drained fluid. In some embodiments, at 942, a clinical condition related to the urinary system, such as a kidney condition, and / or a heart condition, and / or a blood condition, is diagnosed. In some embodiments, at 942, a clinical condition related to the movement of fluid between multiple biological compartments, such as between blood and cells, and / or between blood and the urinary system is diagnosed.

[0391] According to some exemplary embodiments, a clinical condition of the patient is staged at 944. In some embodiments, the clinical condition, such as a disease or a pathological condition, is staged at 944. Optionally, at 940, the clinical condition of the patient is staged based on the plurality of measurements of the drained fluid.

[0392] According to some exemplary embodiments, at 946, the treatment is changed. In some embodiments, at 940, the treatment and / or at least one treatment parameter is changed based on the measured value of the extracted fluid. Alternatively or additionally, the treatment and / or at least one treatment parameter is changed based on the diagnosis of the clinical condition at 942, and / or based on the staging of the clinical condition at 944. In some embodiments, the treatment and / or at least one treatment parameter is changed to adjust the treatment to a new clinical condition of the patient.

[0393] Exemplary process for changing a therapy based on input from a patient and / or a professional

[0394] According to some embodiments, a predetermined treatment regimen is altered, optionally automatically, based on input received from the patient and / or from a specialist during or after the treatment. Fig.9F , which depicts a process for varying a fluid withdrawal therapy based on received input, according to some embodiments of the present invention.

[0395] According to some exemplary embodiments, at 948, an input is received from the patient. In some embodiments, the input from the patient includes a plurality of clinical parameters measured by the patient, such as weight or blood pressure. In some embodiments, the input from the patient includes the following steps of the determined treatment, such as drinking and / or eating patterns, sleep duration and / or body movement.

[0396] According to some exemplary embodiments, at 950, an input is received from an expert, such as a physician. In some embodiments, the input from the expert includes at least one treatment parameter and / or clinical parameter. In some embodiments, the input from the expert includes multiple additional treatment options, and / or multiple treatment instructions, and / or multiple recommended treatment changes.

[0397] According to some exemplary embodiments, at 952, a condition of the patient is diagnosed based on the plurality of inputs received from the patient and / or the expert. In some embodiments, at 952, a hemodynamic condition of the patient is determined based on the inputs of the patient and / or the expert. In some embodiments, at 952, a clinical condition related to the urinary system, such as a kidney condition, and / or a heart condition, and / or a blood condition, is diagnosed. In some embodiments, at 952, a clinical condition related to fluid movement between multiple biological compartments, such as between blood and cells, and / or between blood and the urinary system, is diagnosed.

[0398] According to some exemplary embodiments, at 954, a clinical condition of the patient is staged based on the plurality of inputs received from the patient and / or from the specialist. In some embodiments, at 944, a disease or a pathological condition is staged.

[0399] According to some exemplary embodiments, compliance with the treatment is determined at 956. In some embodiments, the patient's compliance with the treatment is determined at 956 based on a plurality of inputs received from the patient at 948. In some embodiments, the patient's compliance with an overall treatment regimen is determined, for example, with a dietary regimen.

[0400] According to some exemplary embodiments, at 958, an indication is transmitted. In some embodiments, the indication comprises a report, such as a compliance report. In some embodiments, the indication is transmitted to the patient, optionally to a handheld device and / or a computer in communication with the implanted system. Alternatively or additionally, the indication is transmitted to the specialist, such as a physician, via a handheld device and / or a computer in communication with the implanted system. In some embodiments, the implanted system sends a signal to the handheld device and / or the computer to generate an indication, such as a human-detectable indication.

[0401] According to some exemplary embodiments, at 960, the treatment is changed. In some embodiments, the treatment and / or at least one treatment parameter is changed based on the plurality of inputs received from the patient and / or from the specialist. Alternatively or additionally, the treatment and / or at least one treatment parameter is changed based on the analysis of the clinical condition performed at 952, and / or based on the staging of the clinical condition performed at 954. In some embodiments, the treatment and / or at least one treatment parameter is changed based on the treatment compliance determined at 956.

[0402] Exemplary Process for Device Maintenance

[0403] Now please refer to Figure 9G , which depicts a process for device maintenance according to some embodiments of the present invention.

[0404] According to some exemplary embodiments, at 961, the settings of the implantable device are determined. In some embodiments, the settings of the device include a plurality of activation parameters of a pump, such as pump 130. In some embodiments, the plurality of activation parameters of the pump include the duration of activation, the number of activation cycles within a selected time period, and the strength of the vacuum force generated by the pump. In some embodiments, the settings of the device include: establishing a communication channel between the implanted system and an external device, such as a handheld device. In some embodiments, the settings of the device include: adjusting a transmission schedule of instructions, such as a transmission schedule of a compliance report. In some embodiments, the settings of the device include calibration of the device. In some embodiments, the determined settings include: changing and calibrating a learning algorithm, the learning algorithm being used to activate the device, and / or for measuring a plurality of parameters, and / or for automatically changing the treatment.

[0405] According to some exemplary embodiments, at 962, the treatment is started. In some embodiments, the device is operated based on the determined device settings. In addition, the device is operated according to a treatment plan stored in a memory of the device, such as memory 116.

[0406] According to some exemplary embodiments, at 964, the state of the device is determined. In some embodiments, the state of the device is determined at a plurality of predefined time points and / or based on a request from a patient and / or a specialist. In some embodiments, the state of the device includes a battery charge state, a pump activation state, a fluid flow state, and / or a fluid extraction state.

[0407] According to some exemplary embodiments, at 966, an indication is transmitted. In some embodiments, the indication is transmitted if the state of the device is not a desired device state. In some embodiments, an indication is transmitted at 966 if a device failure occurs. Alternatively or additionally, an indication is transmitted if a device component should be replaced or repositioned, such as a membrane, a fluid absorption unit, a catheter, a drain, batteries. In some embodiments, an indication is transmitted if the battery should be charged.

[0408] According to some exemplary embodiments, at least one device component is replaced at 968. In some embodiments, the battery, and / or the membrane, and / or the drain, and / or the fluid absorption unit, or the chamber is replaced.

[0409] Several exemplary treatment plans

[0410] According to some exemplary embodiments, the device is implanted in the patient, optionally with an IV diuretic effect and / or an ultrafiltration effect, after the device is sufficiently stable in the hospital. In some embodiments, the device is implanted in the patient after the patient is diagnosed as resistant (to some extent) to oral diuretics and optionally readmitted to the hospital with the same condition.

[0411] According to some exemplary embodiments, in patients with vascular congestion, the device is coupled to an intravascular pressure monitor, optionally as a surrogate marker for venous congestion. In some embodiments, the device comprises an internal congestion sensor, or is connected to an internal or external congestion sensor. In some embodiments, the device operates until venous filling pressure is reduced to normal values. In some embodiments, the device is activated a short time after reaching normal or near normal values, and / or a reduced vacuum force is applied by the pump. In some embodiments, the system operates until systemic peripheral congestion reaches normal values.

[0412] According to some exemplary embodiments, in patients diagnosed with systemic volume overload, the device is based on impedance water assessment and / or weight assessment, and optionally on a monitor of a surrogate marker of internal hyperemia.

[0413] According to some exemplary embodiments, the device performs an optimization run on a predetermined schedule, such as every 1 to 6 hours, such as every 1, 2, 3, 4, 5, 6 hours or any intermediate value. In some embodiments, the device scans the range of duty cycles: on time: 20 to 180 seconds, such as 30 to 170 seconds, in intervals of 20 seconds or any shorter or longer time period; and off time: 60 to 600 seconds, in intervals of 30 seconds or any shorter or longer time period. Optionally, the device scans the pump power (speed) wherein the pressure is allowed to be maintained in a range of -5:-45 kPa, such as in a range between -5 kPa and -20 kPa, between -15 kPa and -35 kPa, between -20 kPa and -45 kPa, or any intermediate, smaller or larger value or range. In some embodiments, multiple minimum values ​​providing a target discharge rate are set as an operating point until the next optimization run. In some embodiments, an optimal operating point that provides the best performance or fluid extraction efficiency is compared to a previously determined operating point and considered in terms of a target process drainage rate.

[0414] According to some exemplary embodiments, when multiple flow values ​​during the on-activity cycle do not meet the average and required values, the device switches to a static state or a standby state, and optionally performs a measurement of a 'surrogate marker of congestion'. In some embodiments, the measurement of the surrogate marker of congestion is evaluated using internal pressure and multiple flow sensors. In some embodiments, multiple baseline values ​​are corrected for each patient during a clinical evaluation. In some embodiments, during operation, the device scans multiple vacuum pressures (as detailed above) and / or multiple on:off duty cycles, and optionally compares the recovery rate of the pressure in the cavity and the flow rate obtained. In some embodiments, for the same pressure and duty cycle, the faster the recovery time, the higher the degree of congestion. In some embodiments, the device also evaluates the presence of chamber and / or interstitial fluid through multiple pressure-flow curves and / or local impedance measurements. In some embodiments, the measurement of the 'surrogate marker of congestion' is used to evaluate whether a larger operating variable is needed and / or whether there is less displacement.

[0415] According to some exemplary embodiments, the system measures at least one physiological parameter related to a plurality of eating habits of the patient. In some embodiments, the system receives an indication from the patient after eating or drinking. In some embodiments, the system activates the pump for a longer period of time and / or at a higher intensity after the patient eats or drinks.

[0416] According to some exemplary embodiments, the system identifies whether the patient is sleeping. In some embodiments, during the patient's sleep, the system stops the activation of the pump.

[0417] According to some exemplary embodiments, the system measures multiple values ​​of congestion and / or an indication of congestion. In some embodiments, the system calculates the interstitial pressure based on the multiple measured values ​​and adjusts the regimen, at least one treatment regimen, or the multiple work cycles to adapt to the calculated interstitial pressure.

[0418] Several exemplary experimental results

[0419] Now please refer to Fig. 10A , which depicts the difference in drainage rate between the devices, such as a directly engaged lumen and different peritoneal drainage catheters, according to some embodiments of the present invention. According to some exemplary embodiments, the drainage rate is increased 25 times when a homogeneous semipermeable membrane in direct contact with the tissue is used compared to a catheter with discontinuous perforations.

[0420] In some embodiments, for example, Fig. 10A Shown are the differences in drainage rates (normalized for surface area) between 28 measurements from implanted "directly engaged flat lumens" (on various types of membranes) and conventional peritoneal catheters. In some embodiments, having a homogenous semipermeable membrane in direct contact with the tissue is 25 times more advantageous than a catheter with discrete perforations.

[0421] Now please refer to Fig. 10B , which provides a comparison graph comparing the concentrations of various substances in the drained fluid to the concentrations of the various substances in the serum. In some embodiments, the levels of potassium, sodium, and phosphate in the serum are similar to those in the drained fluid. In some embodiments, the levels of creatinine, urea, and albumin in the drained fluid are lower than in the serum. In some embodiments, this comparison graph is used to assess the effect of increasing or decreasing the extraction rate of the fluid on the levels of various substances in the serum, for example, when trying to minimize the level of albumin in the drained fluid.

[0422] Now please refer to Fig. 10C, which depicts a subsequent analysis of a fluid drainage process over a period of time according to some embodiments of the present invention. According to some exemplary embodiments, a disk-shaped absorption cavity covered by a semipermeable membrane achieves a drainage rate that is 6 times higher than a desired relative drainage rate of 0.05% body weight per hour (1.2% / day) over a period of more than six weeks. According to some exemplary embodiments, a polytetrafluoroethylene (PTFE) disk-shaped absorption cavity with a single-sided hole of 15 mm in diameter is covered by a semipermeable membrane. In some embodiments, the cavity is implanted into the peritoneal cavity of six normally hydrated rats. In some embodiments, a microcatheter for draining the fluid from the absorption cavity is guided to a percutaneous port. In some embodiments, the drainage and sampling of the fluid is performed for more than six weeks. Optionally, the drainage rate achieved is maintained at more than 6 times the desired relative drainage rate of 0.05% body weight per hour (1.2% / day).

[0423] Now please refer to Fig. 10D , which depicts a subsequent analysis of a fluid drainage process in multiple pigs over a period of time according to some embodiments of the present invention. According to some exemplary embodiments, an implanted disc-shaped absorbent cavity covered by a semipermeable membrane achieved an average drainage value of 240 ml / day over a period of three to six weeks.

[0424] Now please refer to Fig. 10E , which depicts multiple analytical results of filtration using the absorption chamber under acute volume overload conditions according to some embodiments of the present invention. According to some exemplary embodiments, central venous pressure is increased from 7 mmHg to 16 mmHg, for example, by injecting a highly colloidal Ringer's lactate solution into the vein (12 liters of venous overload in a pig within 3 hours). In some embodiments, as Fig. 10E It has been shown that the increase in central venous pressure also increased the urination rate by 30-fold. In addition, under these conditions, the device increased the drainage rate by 2-fold, which alternatively demonstrates sensitivity to congestion levels.

[0425] Now please refer to Fig.10F , which depicts a histological analysis of a membrane used in the implanted system according to some embodiments of the invention. According to some exemplary embodiments, the histological analysis showed very mild foreign body reaction relative to a control device over a one month tissue growth period. In some embodiments, the analysis revealed mild fibrosis, mild inflammation, and formation of a thinner capsule in the membrane used in the implanted system compared to a control membrane.

[0426] exist Fig.10FIn block A of the test device, multiple cells can be seen on both sides of the membrane (nuclei of the multiple cells are stained in blue), and the membrane is stained in light brown. When a membrane of the test device is used, multiple cells appear only on the outer side of the membrane and not on the inner side (nuclei stained in blue do not appear at the inner side of the membrane), as shown in FIG. Fig.10F The B block is shown.

[0427] According to some exemplary embodiments, for example, Fig.10F As shown, a histological analysis showed very mild foreign body reaction of the device relative to a control group during a one month tissue growth period. In some embodiments, a thin capsule is formed on the membrane after implantation.

[0428] According to some exemplary embodiments, the membrane comprises a plurality of pores having a size range of 0.4 to 5 microns, such as 0.4, 0.5, 0.8, 1, 2, 5 microns or any intermediate size. In some embodiments, the surface of the membrane is treated, such as by hydrophilic Teflon. In some embodiments, the surface of the membrane is smooth, such as, not like a mesh cloth.

[0429] Now please refer to Figure 10G , which depicts a comparison table of working cycles according to some embodiments of the present invention. According to some exemplary embodiments, in order to avoid termination of fluid extraction due to continuous drainage, the device is intermittently activated according to multiple working cycles. In some embodiments, the maximum drainage volume and the maximum drainage rate are achieved under a working cycle of 60 seconds of active state and subsequent 60 seconds of standby state. In some embodiments, the implanted system corrects the multiple working cycles for each patient, optionally during a setup phase and / or during treatment. In some embodiments, the multiple working cycles for each patient are corrected, for example, to achieve the most efficient drainage process. In some embodiments, the multiple working cycles are corrected by measuring the drainage volume, the average drainage rate and / or the flow rate using the device. In some embodiments, the multiple working cycles are optimized for each patient based on at least some of the parameters appearing in the table.

[0430] According to some exemplary embodiments, during continuous drainage, secretions cease after a few minutes and are not retained unless resumed.

[0431] Now please refer to Fig. 10H , which depicts a blockage rate due to protein clogging during an accelerated test according to some embodiments of the present invention.

[0432] According to some exemplary embodiments, a membrane, such as membrane 110, maintains a constant value of fluid extraction rate compared to a conventional catheter, optionally by avoiding or minimizing the blockage of pores of the membrane.

[0433] Exemplary pressure changes in the fluid extraction chamber

[0434] According to some exemplary embodiments, with a fluid extraction chamber, such as Figure 1 The fluid absorption unit 104 is shown with a membrane that is partially blocked, for example, due to a protein blocking process. In some embodiments, changes in pressure within the fluid extraction chamber mitigate or prevent blockage of the membrane. In some embodiments, the pressure change, optionally a momentary pressure change, is applied to the membrane, for example, by using a pushback mechanism.

[0435] According to some exemplary embodiments, an implantable system, such as Figure 1 The system 102 is shown to apply a unidirectional hydrostatic pressure gradient continuously or intermittently. In some embodiments, the applied pressure drives fluid through the cover membrane and into the fluid extraction chamber. In some embodiments, for example, the application of pressure pushback allows the membrane to be optionally refreshed by shaking and / or vibrating the membrane without flushing the membrane. In some embodiments, the optional flushing of the membrane with fresh clean fluid and / or with previously drained fluid introduces the complexity of introducing clean fluid into an implantable device. Alternatively or in addition, flushing of the membrane exposes the peritoneal cavity to the risk of contamination by infected fluid that comes into contact with bladder fluid.

[0436] According to some exemplary embodiments, the pressure change is optionally accompanied by the application of the pressure pushback, for example, to achieve an efficient membrane renewal level, for example, to reduce the aggregated protein content of the membrane by 5% to 80% and proportionally restore the permeability, and the pressure change is instantaneous, for example, to minimize the diversion of reverse fluid flow through the membrane. Now please refer to Figures 11A to 11D , which depicts a plurality of systems for producing a pressure change within the fluid extraction chamber according to some exemplary embodiments of the present invention.

[0437] According to some exemplary embodiments, for example, Fig.11AAs shown, a fluid extraction cavity, such as an absorption cavity 1104, is associated with a membrane, which is optionally positioned within the cavity, on the outer surface of the cavity, and / or the outer surface of the fluid extraction cavity is made of the membrane. In some embodiments, the absorption cavity 1104 is connected to a pump, such as a directional pump configured to apply negative pressure within the absorption cavity 1104, through a tube. In some embodiments, the pump 1110 is used to selectively push fluid into the bladder, renal pelvis, implanted reservoir or outside the body through an outlet 1112.

[0438] According to some exemplary embodiments, a control circuit, such as a controller, generates a plurality of pressure changes by intermittently activating the pump. In some embodiments, the controller temporarily deactivates the pump and reactivates the pump after a short period of time as short as 5 seconds, such as 0.5 seconds, 1 second, 1.5 seconds, or any intermediate or shorter or longer period. In some embodiments, the control circuit generates a plurality of pressure changes by intermittently activating the pump ... Figure 1 The memory 116 is shown with a scheme for intermittently activating the pump.

[0439] According to some exemplary embodiments, the absorption chamber 1104 is connected to the pump 1110 via a valve, such as a solenoid valve 1120 and / or a pinch valve 1116. In some embodiments, for example, Fig.11A As shown, the absorption chamber 1104 is connected to a compliance tube 1114, such as a compliance tube of a pinch valve 1116, through an inlet tube 1106. In some embodiments, a valve, such as the solenoid valve 1120, is connected to the compliance tube 114. In some embodiments, fluid flows from the absorption chamber 1104 through the compliance tube of the pinch valve 1116 and the solenoid valve 1120. In some embodiments, the at least one valve in the fluid flow path between the absorption chamber 1104 and the pump 1110, such as the solenoid valve 1120 and / or the pinch valve 1116, is electrically connected to a controller of the system 1102, such as the controller 1118. Optionally, the controller is electrically connected to the pump 1112 and controls the activity of the pump.

[0440] According to some exemplary embodiments, the activation of the at least one valve, such as the solenoid valve 1120 and / or the pinch valve, changes the pressure level within the inlet tube 1106 and the absorption chamber 1104. In some embodiments, the multiple changes in the pressure level allow proteins and other bioactive compounds to be separated and / or removed from the at least one membrane associated with the absorption chamber. In some embodiments, the multiple pressure changes caused by the activation can be selected as a momentary activation of the solenoid valve 1120 and / or the pinch valve 1116, a plurality of short pressure changes. Additionally or alternatively, the multiple pressure changes are gradual pressure changes.

[0441] According to some exemplary embodiments, for example, Fig. 11B As shown, the absorption chamber 1104 is connected to the pump 1110 via the inlet tube. In some embodiments, the pump 1110 applies a negative pressure to the absorption chamber and to a membrane associated with the chamber via the inlet tube 1106. In some embodiments, a valve, such as a solenoid valve 1142, is disposed in a fluid flow path, such as flow path 1138, that bypasses the pump 1110. In some embodiments, the flow path 1138 interconnects the inlet tube 1106 and an outlet 1140 of the pump 1110. Optionally, the solenoid valve 1142 is activated under the control of a controller 1144. In some embodiments, activation of the solenoid valve 1142, such as opening and closing of the valve, causes multiple changes in pressure, such as a brief increase in positive pressure within the absorption chamber that causes the plurality of biologically active compounds to be separated and / or removed from a membrane associated with the chamber. In some embodiments, these pressure changes are instantaneous and / or gradual.

[0442] According to some exemplary embodiments, for example, Fig. 11C As shown, a system 1150 includes at least one pump, such as a pump 1162, positioned in a flow path, such as a tube, between an inlet tube 1106 and an outlet 1160 of the pump 1110. Alternatively, the pump 1162 is positioned in a flow path, such as a tube, between a compliance tube, such as a compliance tube 1158 exiting the pump 1110, and the inlet tube 1106. In some embodiments, the pump 1162 actively applies positive pressure within the inlet tube 1106 and the absorption chamber, optionally causing separation and / or removal of proteins and other bioactive compounds from a membrane associated with the chamber.

[0443] According to some exemplary embodiments, the pump 1162 comprises a diaphragm pump or a positive displacement pump, which applies opposite fluid pulses to the inlet pipe 1106 to increase the positive pressure in the absorption chamber. In some embodiments, the pump 1162 is activated under the control of a controller 1164, which is electrically connected to the pump 1162. Optionally, the pump 1162 is activated based on a plurality of signals received from a sensor 1152, such as a pressure sensor, configured to measure the pressure in the inlet pipe 1106 and / or in the absorption chamber 1104. In some embodiments, the controller 1164 that controls the activation of the pump 1162 is electrically connected to the sensor 1152.

[0444] According to some exemplary embodiments, for example, Fig.11D As shown, the pump of a system 1170, such as a bidirectional pump 1172 that generates negative pressure in the absorption chamber 1104, is also configured to generate positive pressure. In some embodiments, the pump 1172 is configured to generate positive pressure, optionally multiple short pulses of positive pressure, in the inlet tube 1106 and the absorption chamber 1104. Alternatively or additionally, the pump 1172 is configured to generate multiple short pulses of negative pressure in the absorption chamber. In some embodiments, the pump 117 comprises a bidirectional pump, such as a bidirectional gear pump.

[0445] According to some exemplary embodiments, a positive pressure is generated in the absorption chamber while fluid, for example from a bladder or any other chamber connected to the outlet tube, flows back into the inlet tube and / or the absorption chamber. In some embodiments, a two-way valve, such as a check valve, is positioned on the outlet tube, for example, to prevent fluid from flowing back into the system.

[0446] Now please refer to Fig.11E , which depicts multiple pressure changes in an absorption cavity according to some embodiments of the present invention. According to some exemplary embodiments, negative pressure is applied at T0, for example by a pump, optionally a vacuum pump. In some embodiments, the negative pressure is applied to a drainage tube connected to the absorption cavity and / or in the absorption cavity, for example, to directly draw fluid from a tissue and into the chamber of the absorption cavity. Optionally, when the negative pressure is applied, the surface of the cavity is tightly attached to the tissue, optionally a flat surface of the cavity is tightly attached to the surface of the tissue.

[0447] According to some exemplary embodiments, the negative pressure level is reduced by applying a low level of negative pressure or positive pressure at T1, for example by using Figures 11A to 11DThe devices or features described herein. In some embodiments, a total pressure level L1 combining negative pressure, such as vacuum, and applied positive pressure is a negative pressure lower than pressure level 0. In some embodiments, the total pressure level L1 is a negative pressure level to maintain a tight adhesion between the absorption cavity and / or a membrane associated with the absorption cavity and the tissue. In addition, the total pressure level L1 is a negative pressure level, for example, to prevent fluid or other substances from being released from the chamber of the absorption cavity into a space between the absorption cavity and the tissue, and / or directly into the tissue.

[0448] According to some exemplary embodiments, a reduced negative pressure period (T2-T1) is determined by a control circuit of the system, optionally based on one or more treatment plans and / or multiple activation parameters stored in a memory of the system. Additionally or alternatively, a time T1 for applying a lower negative pressure level, and / or a time period between multiple consecutive intervals of application of multiple lower negative pressures, and / or the application of multiple positive pressures (T3-T1 or T3-T2) is determined by a control circuit of the system, optionally based on one or more treatment plans and / or multiple activation parameters stored in a memory of the system.

[0449] Exemplary Validation Experiment for Testing Positive Pressure Application

[0450] Now please refer to Fig. 12A and 12B , which depicts multiple results of an experiment for testing the effect of positive pressure on membrane protein expression. In the experiment, the effect of applying positive pressure on fibroblast cultures was tested, also referred to herein as "pushback". The effect was tested in three different experimental settings:

[0451] A. The membrane was statically immersed in a buffered solution of activated fibroblasts (without dynamic flow) for three weeks.

[0452] B. Dynamic setup, where the solution is circulated through the membrane under test for the same period of time

[0453] C. Pushback setting, where a brief pulse of reverse flow is applied twice a day for the same period of time

[0454] like Fig. 12A As shown, several dense and low porosity membranes corresponding to the submicron range tend to block more rapidly under the tested conditions, such as Fig.10F It was shown that a push-back can benefit by restoring protein levels to those present in static immersion (without compromising its permeability). Applying a brief pulse of reverse flow (push-back) to a 0.45 micron membrane placed in circulation can reduce the protein concentration on the membrane by about 50% compared to a membrane placed in circulation alone (dynamic).

[0455] like Fig. 12B As shown, to confirm the ability to apply instantaneous pressure changes in the absorption cavity by the push-back of small amounts of liquid, the pressure changes were recorded during brief push-backs of different volumes of fluid back into the cavity (1 to 3 ml into a cavity volume of approximately 80 ml).

[0456] The tests showed that in a non-dense liquid environment, the compliance of the chamber is limited due to the internal skeleton of the cavity being constrained by the elasticity of the membrane compound, and that brief returns of small volumes (1 to 4% of the volume) due to the baseline vacuum allow changes in the pressure gradient applied to the membrane by up to 75 to 85%.

[0457] Exemplary Introduction Systems

[0458] Now please refer to Fig.13A and 13B , which depicts a delivery system for the absorption chamber according to some embodiments of the present invention. According to some exemplary embodiments, a delivery system 1302 includes a hollow distal sleeve 1306, which includes a folded absorption chamber, such as a permeable bag. In some embodiments, the folded absorption chamber is folded in the hollow distal sleeve 1306. In some embodiments, the folded absorption chamber includes a membrane or is at least partially made of the membrane, as described herein. In some embodiments, the hollow distal sleeve 1306 is slidable on an introducer shaft 1304, optionally an extendable and / or a retractable introducer shaft. In some implementations, the introducer shaft 1304 is slidable on a fixed internal shaft 1317. In some embodiments, the introducer shaft 1304 and / or the fixed internal shaft 1317 are connected to a handle 1308, such as a rotatable handle, which is configured to allow the introducer shaft coupled to the absorbent cavity to be manipulated to a desired position within a cavity, such as in the peritoneum. Optionally, the handle 1308 is configured to manipulate the introducer shaft and the coupled absorbent cavity to a desired position and / or an orientation that allows attachment, optionally allowing at least a portion of the absorbent cavity and / or the membrane to be tightly attached to a tissue surface.

[0459] According to some exemplary embodiments, a proximal end of the introducer shaft 1304 is connected to a tube, such as a corrugated tube 1312, which can be optionally made of silicone. In some embodiments, the corrugated tube 1312 is a compressible elastic concertina tube. In some embodiments, the delivery system 1302 includes a cartridge 1310. In some embodiments, the cartridge 1310 includes a braided skeleton tube, such as Figure 3M Tube 338 is shown. In some embodiments, the braided skeleton tube is spirally wound in the cartridge 1310, for example, to reduce the storage volume within the cartridge 1310. In some embodiments, a user advances the stored braided skeleton tube stored in the cartridge 1310 through the corrugated tube 1311 and through a chamber of the introducer shaft into the absorbent cavity.

[0460] According to some exemplary embodiments, the absorbent cavity is deployed before the braided skeleton tube is pushed from the cassette 1310 into the deployed and folded absorbent cavity. Alternatively, the braided skeleton tube is pushed from the cassette 1310 into the absorbent cavity during deployment of the absorbent cavity. Optionally, when the absorbent cavity is deployed and contains the braided skeleton tube, the handle is used to attach a flat surface of the absorbent cavity to a surface of the tissue.

[0461] According to some exemplary embodiments, the cartridge includes at least one opening, such as a flush port 1314 and / or a vent luer, optionally connected to a proximal end of the braided skeleton tube placed in the cartridge 1310. In some embodiments, the vent luer allows for ventilation, such as for disinfection and / or flushing, such as to reduce friction, when the braided skeleton tube stored in the cartridge 1310 is advanced into the absorption cavity. In some embodiments, the flush port is configured to allow flushing and reduce friction, as described above. Alternatively or in addition, the flush port allows for the introduction of a needle or a guide wire to assist the absorption cavity within the body cavity, such as within the peritoneum.

[0462] According to some exemplary embodiments, the system 1302 includes at least one safety controller, such as a release safety clip 1311. In some embodiments, the release safety clip 1311 is used to ensure the intentional release of the absorption cavity in the body cavity. In some embodiments, the release safety clip 1311 controls the movement of the handle 1308. Alternatively, the release safety clip controls the braided skeleton tube to be advanced into the deployed absorption cavity through the introducer shaft 1304, and alternatively or additionally, the safety clip prevents the introduction system from being released from the absorption cavity.

[0463] According to some exemplary embodiments, for example, Figures 14A to 14C As shown, at least a portion of a port connector 1404, such as a distal section, is positioned within an opening 1401 of the absorbent chamber 1402. In some embodiments, a proximal section of the port connector is placed within a distal partially split section of the fixed inner shaft 1317. In some embodiments, a clamping member 1315 is connected to an outer surface of the shaft 1408, and the clamping member 1315 is configured to allow the shaft 1408, which is optionally a movable shaft, to be clamped and retracted. In some embodiments, the distal end of the shaft 1408 is positioned around the distal partially split section 1406 and prevents opening of the partially split section 1406. In some embodiments, retraction of the shaft 1408, such as sliding of the shaft 1408 on the fixed inner shaft 1317, relieves an external pressure applied to the partially split section 1406.

[0464] Exemplary Port Connectors

[0465] Now please refer to Fig.14E, which depicts a port connector according to some embodiments of the present invention. According to some exemplary embodiments, a port connector 1422 includes a distal block 1424 and a proximal block 1426. In some embodiments, the distal block is shaped and sized to be positioned within an opening of an absorbent cavity. Optionally, an outer diameter of the distal block is smaller than an outer diameter of the proximal block 1426. In some embodiments, the outer diameter of the proximal diameter is adjusted to fit within the interior of a split section of a fixed internal shaft, such as a split section 1406 of a shaft 1408. In some embodiments, one or more friction increasing elements, such as a plurality of O-rings 1428 and 1429, allow for increased friction between a tube inserted into the port connector 1422 and the connector. In some embodiments, a tube connector at a distal end of the tube is inserted through the opening 1433 and interacts with a plurality of internal surfaces 1425 located in the lumen of the distal block of the port connector. In some embodiments, the internal surfaces exert friction on the tube connector.

[0466] According to some exemplary embodiments, the proximal block 1426 of the port connector 1422 includes one or more bumps and / or grooves and / or openings, for example, a plurality of grooves 1427 in an outer surface and / or an inner surface of the proximal block 1426. In some embodiments, the one or more bumps and / or grooves and / or openings are used to allow clamping or release of the proximal block 1426, for example, with Fig. 14C and 14D The partially split blocks 1406 shown interact. In some embodiments, the one or more nubs and / or grooves and / or openings are used to increase friction and / or to interlock the proximal blocks during deployment of the absorbent chamber and / or when the absorbent chamber is withdrawn from the subject.

[0467] According to some exemplary embodiments, an external force is applied to the proximal block, such as by a clamping device for extracting the cavity, and the tube is simultaneously pulled from the inner cavity to allow the tube to be withdrawn from the absorption cavity. In some embodiments, the proximal block 1426 allows, for example, the absorption cavity to be withdrawn from the body. In some embodiments, a port connector, such as port connector 1422 with a conical surface and two O-rings, provides a certain connector locking force and a release force about 4 times higher, for example, for withdrawing to withdraw an inner tube from the absorption chamber.

[0468] Exemplary deployment of the absorbent cavity

[0469] According to some exemplary embodiments, a folded absorbent cavity expands when released from an envelope or a housing. In some embodiments, the folded absorbent cavity expands when an autonomous expansion element expands, for example, to a relaxed state. Alternatively or in addition, the folded absorbent cavity expands when fluid is pushed into the folded absorbent cavity. Optionally, the cavity expands when a gas, such as air, is pushed into the cavity through an opening of the cavity. Now referring to Fig.15 , which depicts an autonomously expandable absorption cavity according to some embodiments of the present invention.

[0470] According to some exemplary embodiments, an absorption cavity, such as absorption cavity 15, is an autonomously expandable absorption cavity. In some embodiments, the absorption cavity 1502 comprises an autonomously expandable internal support, such as a thin wire, configured to be opened to a relaxed state when the absorption cavity is released from an outer shell or an envelope. In some embodiments, the expansion of the autonomously expandable internal support exerts a force on the inner surface of the absorption cavity, for example, to maintain a flat and / or thin shape of the absorption cavity.

[0471] Exemplary system introduction process

[0472] According to some exemplary embodiments, the peritoneum of a subject is inflated. In some embodiments, the peritoneum is inflated by introducing a gas, such as air, into the abdominal cavity. Alternatively, the peritoneum is inflated by inserting a tube connected to a gas source at least partially into the abdominal cavity.

[0473] According to some exemplary embodiments, a distal end of a catheter is introduced into a subject's bladder through the peritoneal cavity, and in some embodiments, a proximal end of the catheter is positioned outside the body, the proximal end being the end of the catheter distal to the bladder. Alternatively, the proximal end of the catheter is positioned intraperitoneally. Optionally, the catheter is a pigtail catheter.

[0474] According to some exemplary embodiments, the hollow distal sleeve 1306 containing a folded absorbent cavity is introduced into the abdominal cavity through an opening in the abdominal wall. Alternatively, the hollow distal sleeve with the folded absorbent cavity is introduced into the abdominal cavity through an opening of a trocar catheter.

[0475] According to some exemplary embodiments, when the hollow distal sleeve 1306 is located at a desired position in the abdominal cavity, the distal sleeve 1306 is retracted in a direction toward the handle 1308. In some embodiments, the distal sleeve 1306 is retracted by clamping and retracting the clamping member 1303 located on the distal sleeve 1306, optionally at a proximal end of the distal sleeve 1306. In some embodiments, the retraction of the distal sleeve unfolds the absorbent cavity. Optionally, the retraction of the distal sleeve 1306 exposes the absorbent cavity in the abdominal cavity.

[0476] According to some exemplary embodiments, a tube, such as a braided skeleton tube, located within the cassette 1310 is advanced into the folded absorbent cavity by pressing the corrugated tube, for example, to support the braided tube and move the tube in a direction 1307. In some embodiments, the tube located within the cassette 1310 comprises a silicone tube, which is wrapped by a metal mesh, so that the metal mesh is configured to protect the inner silicone tube from multiple compressive forces. In some embodiments, the metal mesh includes one or more visual indicators, for example, to monitor the advancement of the mesh from the cassette into the absorbent cavity. In some embodiments, pressing the corrugated tube allows the metal mesh surrounding the tube to be supported and the metal mesh and the inner tube to be moved in the direction 1307 into the folded absorbent cavity.

[0477] According to some exemplary embodiments, the metal tube and the inner tube are pushed into the folded absorption chamber while fluid is introduced through the flushing port 1314 and / or through the vent luer 1316, for example, to reduce friction between the metal mesh and the inner surface of the absorption chamber.

[0478] According to some exemplary embodiments, an indication is provided when a desired length of the metal mesh and the inner tube is placed in the absorption chamber. Optionally, the indication is a visible indication and is conveyed through a window or an opening in the cartridge 1310 and / or the introduction shaft. In some embodiments, the metal mesh and the inner tube are advanced into the absorption chamber until a lock, such as an interference lock, on the metal mesh and / or the inner tube is locked in a proximal block of a port connector at least partially positioned in the absorption chamber, such as Fig.14A Port connector 1404 is shown. In some embodiments, the interference lock on the metal mesh prevents movement of the metal mesh and / or the inner tube relative to the absorption cavity and / or relative to the port connector.

[0479] According to some exemplary embodiments, when an indication is provided and / or when the interference lock locks the metal mesh and / or the inner tube, a safety clip, such as Fig. 13B The safety clip 1311 is shown removed. In some embodiments, the safety clip prevents the introduction system from being released from the absorption chamber, for example, by preventing further retraction of the clamping member 1315 toward the handle 1308. In some embodiments, the clamping member 1303 of the distal sleeve 1306 is interconnected with the clamping member 1315 and is used to retract the clamping member 1315 in a direction toward the handle 1308.

[0480] According to some exemplary embodiments, the retraction of the shaft 1304 allows a portion of the split distal block, e.g. Fig. 14C The partially split region 1406 is shown opened and releasing the absorption cavity within the peritoneum. In some embodiments, retraction of the introduction system allows a proximal opening of a tube connected to the absorption cavity to be positioned outside the body or within the peritoneum.

[0481] According to some exemplary embodiments, a control unit, such as Figure 1 The control unit 106 shown or Figure 5E The control unit 514 is shown connected to the proximal opening of the tube and to a proximal opening of a catheter. In some embodiments, the control unit is then positioned inside the body, such as subcutaneously. Alternatively, the control unit and the distal end of the catheter are positioned outside the body, for example, to allow fluid to be drained from the absorption cavity into an external container.

[0482] It is expected that many related fluid extraction devices will be developed during the patent life of the present application; the scope of the term fluid extraction is intended to include a priori all such new technologies.

[0483] As used herein, the term "about" with respect to an amount or value means "within ±10% of."

[0484] The various terms "comprises," "comprising," "includes," "including," "having" and their cognates mean "including but not limited to."

[0485] The term "comprising" means "including and limited to."

[0486] The term "consisting essentially of" means that a composition, method, or structure may include additional ingredients, steps, and / or parts, but only if the additional ingredients, steps, and / or parts do not materially change the basic and novel characteristics of the claimed composition, method, or structure.

[0487] 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.

[0488] Throughout the application, multiple embodiments of the invention may be presented in the form of a range. It should be understood that the description in the form of the range is merely for convenience and brevity and should not be interpreted as an immutable limitation on the scope of the invention. Therefore, the description of a range should be considered to have specifically disclosed all possible sub-ranges and individual values ​​within this range. For example, a description of a range such as from 1 to 6 should be considered to have specifically disclosed multiple sub-ranges, 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 multiple individual values ​​within this range, such as 1, 2, 3, 4, 5 and 6. This applies regardless of the breadth of the range.

[0489] Whenever a numerical range is indicated herein (e.g., "10-15," "10 to 15," or any pair of numbers linked by these other such range indications), unless the context clearly indicates otherwise, it is meant to include any number (decimal or integer) within the indicated range limits, including multiple range limits. The phrases "range / ranging / ranges between" and "range / ranging / ranges from" a first indicating number and a second indicating number, "to," "up to," "until," or "through" (or other such range indicating terms) a second indicating number are used interchangeably herein and are meant to include the first indicating number and the second indicating number and all decimals and integers therebetween.

[0490] Unless otherwise indicated, the numerals used herein and any numerical ranges based upon the numerals are approximations within reasonable measurements and accuracy of rounding errors, as understood by those skilled in the art.

[0491] The term "method" as used herein refers to ways, means, techniques and processes for accomplishing a specific task, including but not limited to those ways, means, techniques and processes that are known or readily developed by practitioners in the fields of chemistry, pharmacology, biology, biochemistry and medicine from known ways, means, techniques and processes.

[0492] As used herein, the term "treating," ...

[0493] It should be understood that certain features of the invention described in the context of individual embodiments for clarity may also be provided in combination in a single embodiment. Conversely, various features of the invention described in the context of a single embodiment for brevity may also be provided individually, or in any suitable subcombination, or in any other described embodiment applicable to the invention. Certain features described in the context of various embodiments are not considered to be essential features of those embodiments unless the embodiment is inoperable without those elements.

[0494] Although the present invention has been described in conjunction with a number of specific embodiments of the present invention, it is apparent to those skilled in the art that many substitutions, modifications and variations are apparent. Therefore, it is intended to cover all such substitutions, modifications and variations that fall within the spirit and broad scope of the appended claims.

[0495] All publications, patents, and patent applications mentioned in this specification are incorporated herein by reference in their entirety to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated herein by reference. In addition, the citation or identification of any reference in this application should not be construed as an admission that such reference is available as prior art to the present invention. With respect to the scope of the section headings used, they should not be construed as necessarily limiting.

Claims

1. An implantable fluid extraction system, wherein the shape and size of the fluid extraction system are convenient for implantation into a patient, characterized in that: The fluid extraction system comprises a fluid extraction chamber, and the fluid extraction chamber comprises: a permeable bag preformed to form a flat and thin body, wherein the permeable bag comprises an opening; and An elastic inner support is configured to be deployed into the permeable bag through the opening after the permeable bag is introduced into the patient's body, wherein the elastic inner support stretches the permeable bag to maintain the flat and thin shape of the permeable bag.

2. The fluid extraction system according to claim 1, characterized in that: The resilient inner support is sufficiently rigid to prevent the permeable bag from collapsing inwardly when a vacuum is applied to an interior cavity of the permeable bag.

3. The fluid extraction system according to claim 1, wherein: The fluid extraction lumen is small or thin enough to be placed in the peritoneum.

4. The fluid extraction system according to claim 1, wherein: The system further includes a porous homogeneous membrane layer on an exterior surface of the permeable bag.

5. The fluid extraction system according to claim 1, wherein: The system further includes a porous membrane within a chamber of the permeable bag.

6. The fluid extraction system of claim 1, wherein: The permeable bag is at least partially made of a porous membrane layer.

7. The fluid extraction system of claim 1, wherein: The elastic inner support includes: an inner elongated stylet disposed in an inner cavity of the elastic inner support, wherein the inner elongated stylet maintains the flat and thin body of the permeable bag.

8. The fluid extraction system of claim 7, wherein: The inner elongated stylet has a flat and thin cross section or a circular cross section.

9. The fluid extraction system of claim 1, wherein: The elastic inner support comprises a braided tube.

10. The fluid extraction system of claim 4, wherein: A maximum dimension of the plurality of pores of the membrane is smaller than the size of a cell.

11. The fluid extraction system of claim 1, wherein: The opening of the permeable bag includes a port and the resilient inner support includes a connector, wherein the connector is configured to interlock with the port to restrict movement of the resilient inner support relative to the permeable bag.

12. The fluid extraction system of claim 1, wherein: The permeable bag comprises two flat layers, The two flat layers are connected to each other along the periphery of the two flat layers; And wherein the two planar layers are connected at at least one connection point in an area surrounded by the periphery.

13. The fluid extraction system of claim 1, wherein: The elastic inner support comprises a tube or a plurality of beads.

14. The fluid extraction system of claim 1, wherein: The permeable bag is preformed to form a fluid extraction chamber, which has a flat and thin shape, is connected to a drainage tube, and includes at least one external flat surface, wherein when a negative pressure is applied to the drainage tube, the at least one external flat surface is configured to adhere to the surface of a tissue, wherein the fluid extraction chamber utilizes the negative pressure to be applied through the flat surface on the surface of the tissue to extract fluid from the tissue.

15. The fluid extraction system of claim 1, wherein: The flat, thin body of the permeable bag includes a flat, resilient outer surface.

16. The fluid extraction system of claim 3, wherein: The system comprises: a drain tube connected to the opening of the permeable bag; and A control unit is connected to the drainage tube and comprises a pump, wherein a control circuit of the control unit activates the pump to apply a negative pressure to the drainage tube.

17. The fluid extraction system of claim 16, wherein: The system includes: at least one implanted physiological sensor connected to the control circuit of the control unit, wherein the at least one implanted physiological sensor is configured to measure multiple values ​​of at least one physiological parameter related to the patient, and wherein the control circuit of the control unit is configured to change the treatment plan according to the multiple values ​​of the at least one physiological parameter.

18. The fluid extraction system of claim 17, wherein: The at least one physiological parameter includes an indication of hyperemia.

19. An implantable fluid extraction system, the fluid extraction system being shaped and sized to be implanted in a patient, characterized in that: The fluid extraction system comprises: The fluid extraction chamber as described in claim 1 has a flat and thin shape, the fluid extraction chamber is connected to a drainage tube and includes at least one external flat surface, wherein when a negative pressure is applied to the drainage tube, the at least one external flat surface is configured to adhere to the surface of a tissue, wherein the fluid extraction chamber utilizes the negative pressure applied by the at least one external flat surface on the surface of the tissue to extract fluid from the tissue.

20. The fluid extraction system of claim 19, wherein: The system comprises a control unit connected to the drainage tube, wherein the control unit comprises a pump for applying the negative pressure to the drainage tube.

21. The fluid extraction system of claim 1, wherein: The elastic inner support comprises an elastic metal mesh.

22. The fluid extraction system of claim 20, wherein: The control unit comprises: a memory for storing at least one treatment plan or a part of the at least one treatment plan; and a control circuit, wherein the control circuit activates the pump according to the treatment plan.

23. The fluid extraction system of claim 22, wherein: The control circuit sends a signal to the pump to intermittently apply the negative pressure to the drainage tube.

24. The fluid extraction system of claim 19, wherein: The fluid extraction chamber comprises a porous membrane, and wherein the at least one external planar surface is a planar surface of the porous membrane.

25. The fluid extraction system of claim 24, wherein: The porous membrane comprises a plurality of pores, wherein a width of the plurality of pores is less than 5 micrometers.

26. The fluid extraction system of claim 19, wherein: The shape and size of the at least one outer planar surface at least partially conforms to the shape and / or contour of the tissue.

27. The fluid extraction system of claim 22, wherein: The system further includes at least one implanted physiological sensor connected to the control circuit, wherein the sensor measures multiple values ​​of at least one physiological parameter of the patient, and wherein the control circuit is configured to control activation of the pump based on the multiple values ​​of the at least one physiological parameter.

28. The fluid extraction system of claim 27, wherein: The at least one physiological parameter includes the patient's interstitial pressure, and / or blood pressure, and / or blood content, and / or heart rate.

29. The fluid extraction system of claim 28, wherein: The physiological sensor measures the levels of creatinine, and / or albumin, and / or sodium, and / or potassium, and / or urea, and / or phosphate in the contents of the blood.

30. The fluid extraction system of claim 27, wherein: The at least one physiological parameter includes an indication of hyperemia.

31. The fluid extraction system of claim 22, wherein: The system further includes at least one implanted extraction sensor connected to the control circuit, wherein the sensor measures a plurality of values ​​related to at least one parameter of the fluid extracted from the tissue.

32. The fluid extraction system of claim 31, wherein: The at least one parameter comprises the flow of the fluid extracted from the tissue, and / or the pressure of the fluid extracted from the tissue, and / or Or the volume of fluid extracted from the tissue.

33. The fluid extraction system of claim 31, wherein: The at least one parameter includes levels of various biological and / or chemical substances in the extracted fluid.

34. The fluid extraction system of claim 33, wherein: The multiple substances include creatinine, and / or albumin, and / or sodium, and / or potassium, and / or urea, and / or phosphate.

35. The fluid extraction system of claim 31, wherein: The extraction sensor measures congestion or an indication of congestion.

36. The fluid extraction system of claim 19, wherein: The system further comprises: a catheter fluidly connected to the drainage tube, wherein the catheter has a tip connected to the urinary system.

37. The fluid extraction system of claim 19, wherein: The system further includes a reservoir fluidly connected to the drainage tube, wherein the reservoir is shaped and sized to store fluid extracted from the tissue.

38. The fluid extraction system of claim 22, wherein: The control unit further comprises: a communication circuit connected to the control circuit, wherein the communication circuit is connected to a handheld device and / or a remote computer via wireless communication.

39. The fluid extraction system of claim 38, wherein: The communication circuit sends a signal to the handheld device and / or the remote computer to generate a warning signal.

40. The fluid extraction system of claim 38, wherein: The communication circuit receives information from a handheld device and / or a remote computer, wherein the information is stored in the memory.

41. The fluid extraction system of claim 22, wherein: The system further includes: a battery connected to the control unit, wherein the battery provides power to the control unit.

42. The system of claim 19, wherein: The fluid extraction cavity is shaped and sized to directly contact the tissue of the plurality of organs located within the abdominal cavity.

43. The fluid extraction system of claim 19, wherein: The fluid extraction cavity is shaped and sized for subcutaneous implantation.

44. An implantable fluid extraction system, the fluid extraction system being shaped and sized to be implanted in a patient, characterized in that: The fluid extraction system comprises: The fluid extraction chamber of claim 1, connected to a drainage tube, wherein the fluid extraction chamber has at least one flat and porous outer membrane, the outer membrane being shaped and sized to contact a surface of a tissue; and A control unit is connected to the drain pipe, wherein the control unit controls the level of negative pressure generated on the drain pipe according to a scheme so as to mechanically vibrate the at least one flat and porous outer membrane.

45. The fluid extraction system of claim 44, wherein: The control unit comprises: a vacuum pump connected to the drain pipe and configured to generate negative pressure; and A control circuit is electrically connected to the vacuum pump, and the vacuum pump is configured to control the negative pressure generated by the vacuum pump.

46. ​​The fluid extraction system of claim 45, wherein: The control circuit sends a signal to the vacuum pump to generate a plurality of short pulses of low level negative pressure, the plurality of short pulses being sufficient to generate the negative pressure applied to the drain tube.

47. A fluid extraction system according to any one of claims 45 or 46, characterized in that: The system includes at least one valve electrically connected to the control circuit and positioned on the drainage pipe, wherein the control circuit sends a signal to the at least one valve to close or open the drainage pipe when the vacuum pump generates the negative pressure.

48. The fluid extraction system of claim 45, wherein: The system further includes: a flow path connected to the drain pipe and an outlet of the vacuum pump; and at least one valve controlled by the control circuit and positioned on the flow path, wherein the at least one valve controls the flow through the flow path.

49. The fluid extraction system of claim 48, wherein: The control circuit sends a signal to the at least one valve to close or open the flow path when the vacuum pump generates the negative pressure.

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