Body fluid management system and method

Abstract

A bodily fluid management system for selectively discharging bodily fluid from a body cavity includes a valve assembly and a tube for transporting bodily fluid from the body cavity of a person to the valve assembly. The valve assembly is configured to be positioned outside a human body and includes (i) an inlet; (ii) an outlet; (iii) one or more one-way valves positioned between the inlet and the outlet, each one-way valve configured to open and close based on pressure fluctuations between the human body cavity and the one-way valve; and (iv) an adjustable outlet lock configured to selectively prevent bodily fluid from moving through the outlet.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to (i) U.S. non-provisional patent application No. 17 / 733,138, filed on April 29, 2022, and entitled “Fluid-Management System and Method,” and (ii) U.S. non-provisional patent application No. 18 / 108,124, filed on February 10, 2023, and entitled “Fluid-Management System and Method” (which is a continuation-in-part of U.S. non-provisional patent application No. 17 / 733,138, filed on April 29, 2022, and entitled “Fluid-Management System and Method”), the entire contents of which are incorporated herein by reference. Background Art

[0003] Various techniques for draining bodily fluids involve the use of a pump in conjunction with a tube (e.g., a shunt or catheter) to drain bodily fluid from one cavity in the body to another cavity in the body or to a reservoir outside the body. Such techniques may be used for purposes including, for example, draining a person's blood, urine, saliva, cerebrospinal fluid, peritoneal fluid, pleural fluid, and / or bladder lesion fluid.

[0004] Overview

[0005] When body fluid accumulates in a cavity of the human body, it is often desirable to drain the body fluid to another cavity within the body or to the outside of the body. Body fluid may accumulate in various body cavities for one reason or another, such as the pleural cavity, the peritoneal cavity, the cerebrospinal cavity, the breast cavity, the cavity of cystic lesions in the body (e.g., cystic lesions in the breast, cystic lesions in the abdomen, etc.), the cavity left after surgery, etc.

[0006] In some cases, it may be desirable to discharge body fluids by moving the body fluids (i) from a body cavity, (ii) through an implant in fluid communication with the body cavity, and (iii) into an external reservoir located outside the human body. In addition, in some cases, it may also be desirable for a person not to have a permanently attached external discharge reservoir attached to an implant in fluid communication with the body cavity, but rather to have the ability to intermittently discharge the body cavity into an external discharge reservoir when it is convenient for the person. Such selective discharge of body fluids from a body cavity can, for example, help a person discharge body fluid accumulation before it becomes uncomfortable, while also avoiding the need for a permanently attached external discharge reservoir. Allowing a person to control when to selectively discharge body fluids and avoiding the need for a permanently attached external discharge reservoir can provide greater freedom and flexibility than a situation where a person cannot selectively control when to discharge body fluids and / or has a permanently attached external discharge reservoir.

[0007] An example of a situation in which it may be desirable to selectively discharge body fluid from a body cavity of a person to an external discharge reservoir that is not permanently attached to the person is to discharge pleural fluid for the treatment of pleural effusion. Pleural fluid is generally a low-protein fluid that can be present in a relatively small amount (usually 10-20 ml) in each pleural cavity of a person. The pleural cavity is the space between the visceral pleura (i.e., the membrane located on the entire outer surface of each lung) and the parietal pleura (i.e., the membrane lining the inside of the chest wall of each half-thorax). The small amount of pleural fluid in each pleural space is spread very thinly between the visceral pleura and the parietal pleura, thereby providing a large surface tension that mechanically couples the lungs to the chest wall while lubricating these surfaces, thereby allowing the lungs to slide on the chest wall during the respiratory process. In normal healthy people, pleural fluid is constantly produced - largely from fluid leakage from blood and lymphatic vessels in the visceral pleura covering the outer surface of the lungs - and is reabsorbed by lymphatic channels located in the parietal pleura lining the chest wall at substantially the same rate. This dynamic balance exchanges fluid multiple times per day and typically maintains a low total volume in the range of 10 to 20 ml. However, under certain abnormal conditions, such as infection, inflammation, malignancy, heart failure, liver failure, or renal failure, among other possible conditions, the net flow of pleural fluid within the pleural cavity becomes unbalanced, with increased fluid production and / or decreased reabsorption, resulting in excessive accumulation of fluid in the pleural space (e.g., on the order of several hundred milliliters to several liters).

[0008] Excessive accumulation of pleural fluid is called pleural effusion, and adds additional mass that must be moved with each breath, and may lead to pathological compression of lung tissue. This compression leads to considerable difficulty or hindrance in the breathing process. Pleural effusion may lead to various problems, such as dyspnea, shortness of breath, chest pain and / or chronic cough, etc., and may greatly impair a person's quality of life. The discharge of excessive accumulation of pleural fluid may help to alleviate, reduce or eliminate such problems. The treatment of pleural effusion may involve discharging pleural fluid into another body cavity or outside the body, and in some cases, it may be desirable to treat pleural effusion by selectively discharging body fluid from the pleural cavity into an external reservoir.

[0009] Although there are certain body fluid management systems that allow a person to selectively control when to discharge excess body fluid from a body cavity (e.g., the pleural cavity) via an implant so that an external reservoir is not always attached to the implant, these existing body fluid management systems typically utilize a dedicated pump and reservoir assembly that can be removably attached to the implant. The dedicated pump and reservoir assembly includes an active pumping component for pumping body fluid out of the body cavity and a discharge reservoir for collecting the pumped body fluid. The active pumping component is used to force the body fluid to move through the implant and into the discharge reservoir. In an example, the active pumping component is a vacuum-based component that is configured to provide vacuum pressure to facilitate discharge from the body cavity. For example, in one example, the dedicated pump and reservoir assembly includes a vacuum bottle that provides vacuum pressure when attached to the implant and activating the vacuum (e.g., via breaking the vacuum seal of the vacuum bottle) to move body fluid from the body cavity of the person through the implant and into the vacuum bottle.

[0010] When a person wishes to discharge bodily fluids within a body cavity using a dedicated pump and reservoir assembly, the person needs to (i) access the dedicated pump and reservoir assembly, (ii) sterilize both the components of the dedicated pump and reservoir assembly to be connected to the implant and the attachment points of the implant, (iii) attach the dedicated pump and reservoir assembly to the implant, and (iv) activate the active pumping component to facilitate discharge of the body cavity. Furthermore, after completing the discharge of the body cavity, the person then needs to detach the dedicated pump and reservoir assembly from the implant, as well as decontaminate and sterilize the attachment points of the implant. However, existing bodily fluid management systems, such as those that allow a person to selectively control when to discharge excess bodily fluids from a body cavity by utilizing a dedicated pump and reservoir assembly, have many disadvantages.

[0011] One such disadvantage of existing body fluid management systems is that unless a person has access to a dedicated pump and reservoir assembly, the person cannot utilize an implant to discharge body fluid from a body cavity. However, in practice, it is often difficult and / or inconvenient for a person to always carry a dedicated pump and reservoir assembly with them, or to otherwise ensure that they can always access the dedicated pump and reservoir assembly when needed. For example, the dedicated pump and reservoir assembly may be bulky and / or difficult to transport. In addition, a person may often forget to carry the dedicated pump and reservoir assembly with them (e.g., when leaving the person's house for one reason or another, the person may forget the dedicated pump and reservoir assembly and instead leave it at home). Therefore, using existing body fluid management systems, a person may not be able to discharge body fluid from the body at a desired or required time.

[0012] Another disadvantage of existing body fluid management systems is that dedicated pump and reservoir assemblies may be expensive and / or difficult to obtain for people. For example, dedicated pump and reservoir assemblies may be disposable assemblies that are discarded after discharge, and these assemblies may be expensive for the person using the assembly and / or the insurance company of the person using the assembly. In addition, in some examples, the dedicated pump and reservoir assembly includes a reusable pumping component (e.g., a reusable motorized peristaltic pump) and a single-use dedicated discharge line and reservoir, and these may be expensive for the person using the assembly and / or the insurance company of the person using the assembly. This cost issue may make it difficult for people to obtain dedicated pump and reservoir assemblies. In addition, it may be difficult for people to always have dedicated pump and reservoir assemblies at hand and / or obtain dedicated pump and reservoir assemblies when needed. Such problems may reduce compliance with people's treatment plans (e.g., a doctor-specified discharge schedule for discharging body cavities).

[0013] Yet another exemplary disadvantage of existing bodily fluid management systems is that the process of connecting a dedicated pump and reservoir assembly to an implant can be a cumbersome process.

[0014] Another exemplary disadvantage of existing fluid management systems is that the task of connecting the components of the dedicated pump and reservoir assembly to the attachment point of the implant may be associated with a risk of contamination (e.g., if one or more of the attached components are not sterile). In addition, contamination may be associated with a risk of infection, and existing fluid management systems have a reported infection rate of about 5% to 10%. In existing fluid management systems, the reservoir and attachment line are typically single-use and provide sterility. The implant to which the reservoir and attachment line are attached is typically decontaminated, for example, with an alcohol swab or a betadine swab. The sterile disposable attachment line is then connected to the decontaminated portion of the implant. In some existing fluid management systems, the sterile portion passes through the decontaminated portion and enters the interior of the implant that is directly fluidically connected to the pleural space. Due to various reasons, such as bacterial proliferation at the implant entry point and / or distal access to the implant itself, infection may occur during the use of the existing fluid management system. Furthermore, in existing bodily fluid management systems, when an implant is accessed, the system does not actively prevent reverse flow (also referred to herein as "backflow") during the drainage process, and backflow may be associated with a risk of contamination and / or infection.

[0015] To help solve the above and other problems, a new body fluid management system for selectively discharging body fluid from a body cavity is disclosed herein. The disclosed body fluid management system includes a valve assembly and a tube for transporting body fluid from a body cavity of a person to the valve assembly. The valve assembly is configured to be positioned outside the human body and includes: (i) an inlet; (ii) an outlet; (iii) one or more one-way valves positioned between the inlet and the outlet, each one-way valve being configured to open and close based on pressure fluctuations between the person's cavity and the one-way valve; and (iv) an adjustable outlet lock, which is configured to selectively prevent body fluid from moving through the outlet. In some implementations, one or more one-way valves of the valve assembly can take the form of a single one-way valve, while in other implementations, one or more one-way valves of the valve assembly can take the form of two one-way valves arranged in series, and so on. In an implementation in which one or more one-way valves of the valve assembly take the form of two one-way valves arranged in series, the two one-way valves of the valve assembly can be arranged in series in a pumping chamber, which is configured to allow a person to prime the body fluid management system. The tube can be configured to extend from the inlet of the valve assembly to the body cavity of the person and allow body fluid to move from the body cavity of the person to the inlet of the valve assembly. In this way, the body fluid management system can be selectively used by the person to discharge body fluid into any suitable external reservoir, such as a sink, toilet and / or container provided by the person.

[0016] As described above, one or more one-way valves are each configured to open and close based on pressure fluctuations between the body cavity and the one-way valve, which allows body fluid to move out of the outlet and also prevents reverse flow (also referred to herein as "backflow") in the body fluid management system (e.g., liquid and / or air flowing back into the tube). In practice, reverse flow can cause air to be sucked back into the body cavity (e.g., the pleural cavity) or liquid to flow back into the cavity, and such reverse flow can cause various problems, such as infection, by allowing bacteria to enter and / or lung collapse. Therefore, preventing reverse flow can help avoid such problems that may be associated with liquid and / or air flowing back into the tube.

[0017] In addition, the opening and closing of one or more one-way valves can also provide a pumping action, which helps to move body fluid from the cavity through the tube and valve assembly. In this regard, in some examples, the pressure fluctuation between the body cavity and one or more one-way valves occurs based on the breathing action of people's breathing cycle. As a possibility, when the body cavity is the pleural cavity, the pressure between the body cavity and one or more one-way valves swings from positive to negative during the breathing cycle. Based on these fluctuations of the pressure between the body cavity and one or more one-way valves, one or more one-way valves will be closed during inspiration (when the pressure is negative) and opened during expiration (when the pressure is positive). Therefore, in one example, the valve assembly can provide a pumping action, wherein the energy provided by people's breathing action discharges body fluid from the body cavity. Considering this opening and closing caused by respiration, the valve assembly can be used as a pump, so that body fluid moves from the body cavity through the tube, through one or more one-way valves and leaves the outlet.

[0018] In at least some implementations, one or more one-way valves can each be configured to have a low "cracking pressure" such that the one-way valve is configured to transition from a closed state to an open state with a relatively small pressure differential across the one-way valve. For example, the cracking pressure of each one-way valve can be about 25 cmH. 2 O or less to about 5cmH 2 O or less, and as a specific example, the opening pressure of a given one-way valve may be less than about 25 cmH 2 O, less than about 15cmH 2 O, less than about 10cmH 2 O or less than about 5cmH 2 In addition, in at least some implementations, one or more one-way valves can each be configured to have a low "reseal pressure" such that the one-way valve is configured to switch from an open state to a closed state with a small pressure differential across the one-way valve. For example, the reseal pressure of each one-way valve can be about 15 cmH. 2 O or less to about 2 cmH 2 O or less, and as a specific example, the opening pressure of a given one-way valve may be less than about 15 cmH 2 O, less than about 10cmH 2 O, less than about 5cmH 2 O or less than about 2 cmH 2 O.

[0019] Furthermore, the cracking pressure and / or resealing pressure of each of the one or more one-way valves may be selected based on any of a variety of factors, examples of which may be the type of cavity from which the bodily fluid management system is intended to discharge bodily fluid, among other examples.

[0020] In operation, before using the disclosed body fluid management system to discharge a body cavity, a person may first select an external reservoir into which body fluid is discharged from the body, such as a sink, toilet, and / or container provided by the person. Next, to initiate the discharge process, the person may switch the adjustable outlet lock of the valve assembly to an unlocked position. When the adjustable outlet lock is in the unlocked position, the body fluid may begin to move through the body fluid management system due to the pressure of the body cavity and / or the pumping action provided by the valve assembly. This will cause the body fluid to move from the cavity, through a tube extending from the cavity to the inlet of the system, through one or more one-way valves of the system, and then out of the outlet of the system and into the external reservoir. After the discharge process has begun, the person may discharge body fluid from the cavity until the cavity is empty and / or the desired amount of body fluid has been discharged from the cavity. Finally, after the discharge is complete, the person may decontaminate the outlet of the valve assembly and / or the adjustable lock and switch the adjustable lock to the locked position. Alternatively, the adjustable lock may be a locking cover that may be attached to the catheter assembly to seal the valve assembly and prevent the flow of body fluid or removed to allow the flow of body fluid. Finally, the cover can be decontaminated and reattached, or a new cover can be attached.

[0021] The disclosed body fluid management system can also be designed so that when a sufficient amount of body fluid has moved through the body fluid management system, a siphon effect can be utilized to help drain body fluid from the cavity more quickly. For example, the disclosed body fluid management system can be designed so that the pressure and / or pumping action of the body cavity provided by the valve assembly can allow a body fluid column to form within the tube, which in turn causes a siphon effect. The height of the body fluid column can be increased by the patient sitting up or standing or by lowering the distal end of the tube. In other words, the disclosed body fluid management system can be designed so that once the tube is primed by the valve assembly, body fluid from the cavity can be siphoned.

[0022] As described above, in some implementations, one or more one-way valves of the valve assembly may take the form of a single one-way valve, while in other implementations, one or more one-way valves of the valve assembly may take the form of two one-way valves arranged in series. As also described above, in any of these arrangements, the one or more one-way valves are each configured to open and close based on pressure fluctuations between a cavity of the human body and the one-way valve or between a cavity of the human body and the first one-way valve and pressure fluctuations between the first one-way valve and the second one-way valve. In addition, in implementations in which the one or more one-way valves of the valve assembly take the form of two one-way valves arranged in series, relative to a valve assembly having a single one-way valve, the two one-way valves may allow additional capabilities and / or benefits, including but not limited to improving the flow of body fluid movement in a body fluid management system (e.g., when used with a pumping chamber) and / or providing an additional barrier to reverse flow, etc.

[0023] For example, in at least some implementations, two one-way valves of a valve assembly can be arranged in series within a pumping chamber, wherein a first one-way valve can be positioned on a first side of the pumping chamber near the inlet of the valve assembly, and a second one-way valve can be positioned on a second side of the pumping chamber near the outlet of the valve assembly. Such a pumping chamber can be formed of an elastic flexible material that can be compressed and decompressed to provide a pumping action to fill a body fluid management system and move body fluid through the body fluid management system. In this regard, the cyclic compression and decompression of the elastic flexible material can draw body fluid (e.g., liquid and / or air) from the inlet, enter the interior space of the pumping chamber through the first one-way valve, pass through the second one-way valve, and discharge from the outlet of the valve assembly. Therefore, such a dual valve configuration can allow a person to fill a body fluid management system, which can help accelerate the discharge process by moving body fluid through the body fluid management system faster. Such a dual valve configuration can also allow the generation of super-physiological positive and / or negative pressures, which can also be beneficial for removing debris from within the pipeline, from within the one-way valve, and / or from other areas of the valve assembly.

[0024] In addition, in at least some embodiments, the bodily fluid management system includes a valve assembly and a tube for transporting bodily fluid from a human body cavity to the valve assembly, wherein the valve assembly is configured to be positioned outside the human body and includes: (i) an inlet; (ii) an outlet; (iii) a pumping chamber between the inlet and the outlet and configured to be compressed and decompressed to pump the bodily fluid; (iv) a first one-way valve positioned on a first side of the pumping chamber; (v) a second one-way valve positioned on a second side of the pumping chamber; and (vi) an adjustable inlet lock configured to selectively prevent bodily fluid from moving through the inlet, and wherein the tube is configured to extend from the inlet of the valve assembly to the human body cavity.

[0025] Further, in at least some embodiments, a bodily fluid management system includes a valve assembly and a tube for transporting bodily fluid from a body cavity of a person to the valve assembly, wherein the valve assembly is configured to be positioned outside the human body and includes: (i) an inlet; (ii) an outlet; (iii) a pumping chamber between the inlet and the outlet and configured to be compressed and decompressed to pump the bodily fluid; (iv) a first one-way valve positioned on a first side of the pumping chamber; (v) a second one-way valve positioned on a second side of the pumping chamber; (vi) an adjustable inlet lock configured to selectively prevent bodily fluid from moving through the inlet, and wherein the tube is configured to extend from the inlet of the valve assembly to the body cavity of the person; and (vii) an adjustable outlet lock configured to selectively prevent bodily fluid from moving through the outlet, wherein the adjustable inlet lock is positioned upstream of the first one-way valve, and wherein the adjustable outlet lock is positioned downstream of the second one-way valve.

[0026] The bodily fluid management systems (and methods of operation) disclosed herein may provide various benefits over existing bodily fluid management systems that allow a person to selectively control when excess bodily fluid is drained from a body cavity to an external reservoir, such as bodily fluid management systems based on dedicated pump and reservoir assemblies.

[0027] For example, the valve assembly of the disclosed body fluid management system is configured to utilize the pressure gradient generated about the body cavity and the valve system to discharge body fluid from the body cavity, rather than relying on active vacuum-based pumping components (which involve larger, heavier and more expensive components). In addition, the valve assembly of the disclosed body fluid management system is not integrated into a dedicated pump and reservoir assembly, and can be used to discharge body fluid from the body cavity into any available reservoir at any time. Therefore, the disclosed body fluid management system is smaller, lighter and more portable than existing body fluid management systems. Therefore, the body fluid management system can be kept with a person at all times (for example, the external portion of the body fluid management system can be rolled up and attached to the human body or rolled into clothing when not in use), and there is no need for a person to access a dedicated pumping and reservoir assembly.

[0028] Furthermore, given that the bodily fluid management system does not rely on active vacuum-based components and is not integrated into a dedicated pump and reservoir assembly, the disclosed bodily fluid management system may be less costly than existing bodily fluid management systems (e.g., to a person using the assembly and / or to an insurance company of a person using the assembly).

[0029] In addition, by avoiding the need to attach and detach a dedicated pump and reservoir assembly to and from the implant each time a person drains a body cavity, the draining process using the disclosed body fluid management system is less cumbersome than the draining process using existing body fluid management systems.

[0030] In addition, as described above, existing discharge processes involve connecting components of a dedicated pump and reservoir assembly to attachment points of the implant, which may be associated with a risk of contamination (e.g., if one or more of the attached components are not sterile). By avoiding the need to attach a dedicated pump and reservoir assembly to the implant and also to detach the dedicated pump and reservoir assembly from the implant each time a person discharges a body cavity, the disclosed body fluid management system also reduces the risk of contamination compared to existing body fluid management systems. In addition, as described above, in existing body fluid management systems, when the implant is accessed, the system does not actively prevent backflow during the discharge process. The disclosed body fluid management system includes one or more one-way valves that are configured to prevent backflow in the body fluid management system during the discharge process and when the adjustable outlet lock is closed. Actively preventing backflow reduces the risk of contamination and / or infection compared to existing body fluid management systems.

[0031] Thus, in one aspect, a bodily fluid management system is disclosed herein, the bodily fluid management system comprising a valve assembly and a tube for conveying bodily fluid from a body cavity of a person to the valve assembly. The valve assembly is configured to be positioned outside the human body and comprises: (i) an inlet; (ii) an outlet; (iii) one or more one-way valves positioned between the inlet and the outlet, each one-way valve being configured to open and close based on pressure fluctuations between the cavity of the person and the one-way valve; and (iv) an adjustable outlet lock configured to selectively prevent bodily fluid from moving through the outlet.

[0032] In another aspect, a bodily fluid management system is disclosed herein, comprising a valve assembly and a tube for transporting bodily fluid from a body cavity of a person to the valve assembly. The valve assembly is configured to be positioned outside the human body and comprises: (i) an inlet; (ii) an outlet; (iii) a plurality of one-way valves positioned between the inlet and the outlet, each one-way valve being configured to open and close based on pressure fluctuations between the body cavity of the person and the one-way valve; and (iv) an adjustable outlet lock configured to selectively prevent bodily fluid from moving through the outlet. In at least some implementations, the plurality of one-way valves may be arranged in series. In addition, the tube is configured to extend from the inlet of the valve assembly to the body cavity of the person.

[0033] In yet another aspect, a method of operating a body fluid management system is disclosed herein, the body fluid management system including a valve assembly and a tube for transporting body fluid from a body cavity of a person to the valve assembly. The valve assembly is positioned outside the human body and includes: (i) an inlet; (ii) an outlet; (iii) one or more one-way valves positioned between the inlet and the outlet, each one-way valve being configured to open and close based on pressure fluctuations between the body cavity of the person and the one-way valve; and (iv) an adjustable outlet lock configured to selectively prevent body fluid from moving through the outlet. The method includes when the adjustable outlet lock is in a locked position, the adjustable outlet lock prevents body fluid from moving through the outlet. The method also includes when the adjustable outlet lock is in an unlocked position, each of the one or more one-way valves opens and closes based on pressure fluctuations between the body cavity of the person and the one-way valve, so as to provide a pumping action to move body fluid from the body cavity through the tube, into the inlet, and out of the outlet to an external reservoir. In at least some implementations, the fluctuation occurs based on the breathing action of the person's breathing cycle.

[0034] In yet another aspect, a method for bodily fluid management is disclosed herein, the method comprising providing a bodily fluid management system, the bodily fluid management system comprising a valve assembly and a tube for conveying bodily fluid from a body cavity of a person to the valve assembly, wherein the valve assembly is configured to be positioned outside the human body and comprises: (i) an inlet; (ii) an outlet; (iii) one or more one-way valves positioned between the inlet and the outlet, each one-way valve being configured to open and close based on pressure fluctuations between the body cavity of the person and the one-way valve; and (iv) an adjustable outlet lock configured to selectively prevent bodily fluid from moving through the outlet. The method also comprises implanting a portion of the bodily fluid management system into the human body, such that the proximal end of the tube is in fluid communication with the cavity, and the valve assembly is positioned outside the human body.

[0035] In another aspect, a bodily fluid management system is disclosed herein, the bodily fluid management system comprising a valve assembly and a tube for conveying bodily fluid from a body cavity of a person to the valve assembly. The valve assembly is configured to be positioned outside the human body and comprises: (i) an inlet; (ii) an outlet; (iii) a pumping chamber between the inlet and the outlet and configured to compress and decompress to pump bodily fluid; (iv) a first one-way valve positioned on a first side of the pumping chamber; (v) a second one-way valve positioned on a second side of the pumping chamber; and (vi) an adjustable inlet lock configured to selectively prevent bodily fluid from moving through the inlet, and wherein the tube is configured to extend from the inlet of the valve assembly to the body cavity of the person.

[0036] In yet another aspect, a bodily fluid management system is disclosed herein, the bodily fluid management system comprising a valve assembly and a tube for conveying bodily fluid from a body cavity of a person to the valve assembly. The valve assembly is configured to be positioned outside the human body and comprises: (i) an inlet; (ii) an outlet; (iii) a pumping chamber between the inlet and the outlet and configured to be compressed and decompressed to pump bodily fluid; (iv) a first one-way valve positioned on a first side of the pumping chamber; (v) a second one-way valve positioned on a second side of the pumping chamber; (vi) an adjustable inlet lock configured to selectively prevent bodily fluid from moving through the inlet, and wherein the tube is configured to extend from the inlet of the valve assembly to the body cavity of the person; and (vii) an adjustable outlet lock configured to selectively prevent bodily fluid from moving through the outlet, wherein the adjustable inlet lock is positioned upstream of the first one-way valve, and wherein the adjustable outlet lock is positioned downstream of the second one-way valve.

[0037] In yet another aspect, a method of operating a bodily fluid management system is disclosed herein, the bodily fluid management system comprising a valve assembly and a tube for conveying bodily fluid from a body cavity of a person to the valve assembly, wherein the valve assembly is positioned outside the human body and comprises: (i) an inlet; (ii) an outlet; (iii) a pumping chamber between the inlet and the outlet and configured to be compressed and decompressed to pump bodily fluid; (iv) a first one-way valve positioned on a first side of the pumping chamber; (v) a second one-way valve positioned on a second side of the pumping chamber; and (vi) an adjustable inlet lock configured to selectively prevent bodily fluid from moving through the inlet, and wherein the tube is configured to extend from the inlet of the valve assembly to the body cavity of the person. The method comprises: when the adjustable inlet lock is in a locked position, the external portion of the bodily fluid management system is attached to the human body. The method also includes: when the adjustable inlet lock is in the unlocked position, (i) compressing and decompressing the pumping chamber to provide a pumping action to prime the body fluid management system and move body fluid through the body fluid management system, and (ii) after priming the body fluid management system, the body fluid management system siphons body fluid from the body cavity through the body fluid management system.

[0038] These and many other aspects will be appreciated by those of ordinary skill in the art upon reading the following disclosure. BRIEF DESCRIPTION OF THE DRAWINGS

[0039] Figure 1A An exemplary bodily fluid management system according to examples of the present disclosure is shown.

[0040] Figure 1B shows implantation in the human body Figure 1A An exemplary body fluid management system is provided.

[0041] Figure 2A A schematic cross-sectional view of a one-way valve in a closed state is shown.

[0042] Figure 2B A schematic cross-sectional view of a one-way valve in an open state is shown.

[0043] Figure 3 Representative pleural pressures are shown as they change during inspiration and expiration.

[0044] Figure 4A An exemplary bodily fluid management system is shown in accordance with an example implementation.

[0045] Figure 4B shows implantation in the human body Figure 4A An exemplary body fluid management system of the invention.

[0046] FIG. 5A to FIG. 5D shows the various stages of compression and decompression Figure 4A The pumping chamber of the body fluid management system.

[0047] FIG. 6A to FIG. 6B An exemplary adjustable exit lock according to examples of the present disclosure is shown.

[0048] FIG. 7A to FIG. 7B An exemplary adjustable exit lock according to examples of the present disclosure is shown.

[0049] FIG. 8A to FIG. 8D An exemplary adjustable exit lock according to examples of the present disclosure is shown.

[0050] 9A to 9C An exemplary adjustable exit lock according to examples of the present disclosure is shown.

[0051] FIG. 10A to FIG. 10B An exemplary adjustable exit lock according to examples of the present disclosure is shown.

[0052] FIG. 11A to FIG. 11B An exemplary adjustable exit lock according to examples of the present disclosure is shown.

[0053] FIG. 12A to FIG. 12B An exemplary adjustable exit lock according to examples of the present disclosure is shown.

[0054] Fig.13 An example arrangement of an external portion of a bodily fluid management system according to examples of the present disclosure is shown.

[0055] Fig.14 An example arrangement of an external portion of a bodily fluid management system according to examples of the present disclosure is shown.

[0056] Fig.15A An exemplary bodily fluid management system according to examples of the present disclosure is shown.

[0057] Fig. 15B An example according to the present disclosure is shown. Fig.15A An example arrangement of an external portion of a bodily fluid management system.

[0058] Fig.16 An exemplary process for connecting an exemplary bodily fluid management system to an implant according to an example of the present disclosure is shown.

[0059] Fig.17 An exemplary process for connecting an exemplary bodily fluid management system to an implant according to an example of the present disclosure is shown.

[0060] Fig.18 Exemplary method bodily fluid management according to examples of the present disclosure is shown.

[0061] Fig.19 An example method of draining bodily fluid from a body cavity of a person to a reservoir external to the person is shown according to examples of the present disclosure.

[0062] Fig. 20 An example method of draining bodily fluid from a body cavity of a person to a reservoir external to the person is shown according to examples of the present disclosure.

[0063] Fig.21A An exemplary bodily fluid management system according to examples of the present disclosure is shown.

[0064] Fig. 21B An example according to the present disclosure is shown. Fig.21A A cross-sectional view of a valve assembly of an exemplary bodily fluid management system with an adjustable inlet lock in a locked position.

[0065] Fig. 21C An example according to the present disclosure is shown. Fig.21A A cross-sectional view of a valve assembly of an exemplary bodily fluid management system with an adjustable inlet lock in an unlocked position.

[0066] Fig.21D shows implantation in the human body Fig.21A An exemplary body fluid management system is provided.

[0067] FIG. 22A to FIG. 22D shows various stages of compression and decompression according to an example of the present disclosure Fig.21A The pumping chamber of the body fluid management system.

[0068] FIG. 23A to FIG. 23B 1 shows various stages of compression and decompression of a pumping chamber according to an example of the present disclosure Fig.21A Fluid management system.

[0069] FIG. 24A to FIG. 24D An example according to the present disclosure is shown. Fig.21A Various operational stages of an exemplary bodily fluid management system.

[0070] Fig.25A An exemplary bodily fluid management system according to examples of the present disclosure is shown.

[0071] Fig.25B An example according to the present disclosure is shown. Fig.25A A cross-sectional view of a valve assembly of an exemplary bodily fluid management system, wherein the adjustable inlet lock is in a locked position and the adjustable outlet lock is in a locked position.

[0072] Fig.25C An example according to the present disclosure is shown. Fig.25A A cross-sectional view of a valve assembly of an exemplary bodily fluid management system of FIG. 1 , wherein an adjustable inlet lock is in an unlocked position and an adjustable outlet lock is in an unlocked position.

[0073] Fig.25D shows implantation in the human body Fig.25A An exemplary body fluid management system of the invention.

[0074] FIG. 26A to FIG. 26E An example according to the present disclosure is shown. Fig.25A Various operational stages of an exemplary bodily fluid management system.

[0075] Fig. 27 An exemplary pumping chamber according to examples of the present disclosure is shown.

[0076] Fig.28A An exemplary pumping chamber according to examples of the present disclosure is shown.

[0077] Fig.28B A diagram taken along line AA according to an example of the present disclosure is shown. Fig.28A Cross-sectional view of an exemplary pumping chamber.

[0078] Fig.29A An exemplary pumping chamber according to examples of the present disclosure is shown.

[0079] Fig.29B BB according to an example of the present disclosure is shown. Fig.29A Cross-sectional view of an exemplary pumping chamber.

[0080] Fig.30 An exemplary valve assembly according to an example of the present disclosure is shown.

[0081] Fig.31A An example according to the present disclosure is shown. Fig.30 A cross-sectional view of a pumping chamber access port of an exemplary valve assembly.

[0082] Fig.31B An example according to the present disclosure is shown. Fig.30 A cross-sectional view of an inlet access port of an exemplary valve assembly.

[0083] Fig.32A An exemplary valve assembly having an inlet access port that is inaccessible and hidden from view when an adjustable inlet lock is in a locked position is shown according to an example of the present disclosure.

[0084] Fig.32B An example valve assembly is shown when an adjustable inlet lock is in an unlocked position and an inlet access port is accessible according to examples of the present disclosure.

[0085] FIG. 33A to FIG. 33B An exemplary valve assembly for discharging into a bottle is shown according to examples of the present disclosure.

[0086] Fig.34A An exemplary valve assembly according to an example of the present disclosure is shown.

[0087] Fig.34BAn example according to the present disclosure is shown. Fig.34A A cross-sectional view of the body of a pumping chamber of an exemplary valve assembly.

[0088] Fig.35A An example valve assembly configured to be attached to an outer tube is shown according to an example of the present disclosure.

[0089] Fig.35B Attached to the outer tube according to an example of the present disclosure is shown. Fig.35A An exemplary valve assembly of .

[0090] Fig.36A An exemplary one-way valve according to an example of the present disclosure is shown.

[0091] Fig.36B A dry or substantially dry state is shown according to an example of the present disclosure. Fig.36A An exemplary one-way valve.

[0092] Fig.36C A wet or partially wet state is shown according to an example of the present disclosure. Fig.36A An exemplary one-way valve.

[0093] Fig.36D Shows a fully wetted state according to an example of the present disclosure Fig.36A An exemplary one-way valve.

[0094] Fig.37 An exemplary method of bodily fluid management according to examples of the present disclosure is shown.

[0095] Fig.38 An example method of draining bodily fluid from a body cavity of a person to a reservoir external to the person is shown according to examples of the present disclosure.

[0096] Fig.39 An example method of draining bodily fluid from a body cavity of a person to a reservoir external to the person is shown according to examples of the present disclosure.

[0097] Fig.40 An exemplary valve assembly according to an example of the present disclosure is shown.

[0098] Fig.41 An exemplary adjustable pipe lock according to examples of the present disclosure is shown.

[0099] Fig.42A An exemplary valve assembly with an adjustable outlet lock in a closed position is shown according to examples of the present disclosure.

[0100] Fig.42B An example according to the present disclosure is shown. Fig.42A An exemplary valve assembly wherein the adjustable outlet lock is in an open position.

[0101] Fig.43A An exemplary valve assembly is shown with an adjustable outlet lock in a closed position according to examples of the present disclosure.

[0102] Fig.43B An example of the present disclosure is shown in an open position. Fig.43A An exemplary adjustable exit lock.

[0103] Fig.44 An example valve assembly configured to attach to a plurality of adapters is shown according to examples of the present disclosure.

[0104] Fig.45A An exemplary pumping chamber according to examples of the present disclosure is shown.

[0105] Fig.45B An example according to the present disclosure is shown. Fig.45A A cross-sectional view of a portion of an example pumping chamber.

[0106] Fig.45C FIG. 2 shows a flow chart of a pumping chamber according to an example of the present disclosure when a portion of the pumping chamber is compressed. Fig.45A A cross-sectional view of a portion of an example pumping chamber. DETAILED DESCRIPTION

[0107] The following disclosure refers to the accompanying drawings and several example implementations. It should be understood by those skilled in the art that such references are for explanation purposes only and are not intended to be limiting. Parts or all of the disclosed systems, devices, and methods may be rearranged, combined, added, and / or removed in various ways, each of which is contemplated herein.

[0108] As described above, existing fluid management systems and methods that allow a person to selectively control when excess body fluid is discharged from a body cavity so that an external reservoir is not always attached to an implanted tube that is in fluid communication with the body cavity have many disadvantages. The body fluid management methods and systems according to the present disclosure advantageously provide improved methods and systems for discharging body fluid from a body cavity to an external reservoir. Specifically, the methods and systems according to the present disclosure advantageously provide a method that avoids the need to attach a dedicated pump and reservoir assembly, which includes an active pumping component for pumping body fluid out of the body cavity and a discharge reservoir for collecting the pumped body fluid. In contrast, according to the present disclosure, the components that safely and effectively initiate the discharge are always on the person, allowing the person to selectively discharge the body cavity.

[0109] In one example, a body fluid management system for selectively discharging body fluid from a body cavity includes a valve assembly and a tube for transporting body fluid from a person's body cavity to the valve assembly. The valve assembly is configured to be positioned outside the human body and includes: (i) an inlet; (ii) an outlet; (iii) one or more one-way valves positioned between the inlet and the outlet, each one-way valve being configured to open and close based on pressure fluctuations between the person's cavity and the one-way valve; and (iv) an adjustable outlet lock configured to selectively prevent body fluid from moving through the outlet. The body fluid management system can be used by a person to discharge body fluid into any suitable external reservoir. The body fluid to be discharged can include a liquid, a gas, or a combination of a liquid and a gas.

[0110] Turning now to the accompanying drawings, Figure 1A An exemplary bodily fluid management system 100 is depicted, and Figure 1B A bodily fluid management system 100 implanted in a human body 102 is depicted. The bodily fluid management system 100 includes a valve assembly 104 having an inlet 106, an outlet 108, a one-way valve 110, and an adjustable outlet lock 112. The one-way valve 110 is positioned between the inlet 106 and the outlet 108, and is configured to open and close based on pressure fluctuations between a cavity 114 and the one-way valve 110. The bodily fluid management system 100 also includes a bodily fluid management tube 116 for transporting bodily fluid from the cavity 114 to the valve assembly 104. The tube 116 is configured to extend from the inlet 106 to the cavity 114 and allow bodily fluid to move from the cavity 114 to the inlet 106 of the valve assembly 104. The tube 116 is implanted in the human body 102 such that a proximal end 118 of the tube 116 is positioned within the cavity 114 and a distal end 120 of the tube 116 is positioned outside the human body 102. In addition, the valve assembly 104 is located outside the human body 102. In particular, reference is made to Figure 1A , the external portion 117 of the bodily fluid management system 100 is positioned outside the human body 102. Moreover, in the example shown, the internal portion of the bodily fluid management system 100 includes a first portion 119 of the tube 116 positioned behind the ribs and within the cavity 114, and a second portion 121 of the tube 116 positioned in front of the ribs within the human body 102. Other example arrangements of the internal and external portions of the bodily fluid management system 100 are also possible.

[0111] The one-way valve 110 includes a one-way valve frame 130 that encloses the one-way valve 110 and provides structure and support for the one-way valve 110. In addition, the one-way valve frame 130 can also be used to connect to the distal end 120 of the tube 116. The size and shape of the one-way valve frame 130 can be designed to provide a connection point or interconnectable joint to the tube 116. In an example, the valve assembly 104 is non-removably attached to the tube 116. As used herein, the term "non-removably attached" means that a first component (e.g., a valve assembly) is intended not to be removed from a second component (e.g., a tube) during normal use and cannot be easily removed from the second component without using abnormal force and / or tools.

[0112] Cavity 114 may be a cavity within the body 102 that may accumulate bodily fluids that it is desirable or necessary to selectively drain from the body. Figure 1A In the example of FIG. 1 , cavity 114 is the pleural cavity of human body 102. However, other body cavities are possible, such as the peritoneal cavity, the cerebrospinal cavity, the pericardial cavity, the breast cavity, or the cavity of a cystic lesion, etc.

[0113] The adjustable outlet lock 112 is configured to selectively prevent bodily fluids from moving through the outlet 108. In particular, the adjustable outlet lock 112 is configured to move between a locked position, in which the adjustable outlet lock 112 seals the outlet 108, and an unlocked position, in which the adjustable outlet lock 112 allows bodily fluids to move through the outlet 108. The adjustable outlet lock 112 can be controlled by a person, such that when the cavity 114 is not being drained, the person can maintain the adjustable outlet lock 112 in the locked position. In addition, when the person desires to drain the cavity 114, the person can switch the adjustable outlet lock 112 to the unlocked position.

[0114] exist Figure 1A In the example of , the adjustable outlet lock 112 is located at the outlet 108 and is configured to cover the outlet 108 when in the locked position. However, the adjustable outlet lock 112 can be located in other locations, such as upstream of the outlet 108. In addition, in Figure 1A In the example of FIG. 1 , the adjustable outlet lock 112 takes the form of a cover and is locked by securely attaching the cover to the outlet 108. In particular, the locked position of the cover corresponds to the position in which the cover is attached to the outlet 108 (eg, Figure 1B ), and the unlocked position corresponds to the cover not being attached from the outlet 108 (as shown Figure 1A Other adjustable exit locks are possible, some examples of which are described in more detail below.

[0115] As described above, the one-way valve 110 is configured to open and close based on pressure fluctuations between the cavity 114 of the human body 112 and the one-way valve 110. By opening and closing based on pressure fluctuations between the cavity 114 and the one-way valve 110, the one-way valve 110 can allow body fluid to move out of the outlet 108 and also prevent reverse flow (also referred to herein as "backflow") in the body fluid management system 100 (e.g., liquid and / or air flowing back into the tube 116). In practice, reverse flow may cause air to be sucked back into the cavity 114 (e.g., the pleural cavity) or liquid to flow back into the cavity 114, and such reverse flow may cause various problems, such as infection and / or lung collapse. Therefore, preventing backflow can help avoid such problems that may be associated with liquid and / or air flowing back into the tube 116. In addition, in some examples, the opening and closing of the one-way valve 110 can also provide a pumping action that helps move body fluid from the cavity 114 and through the tube 116 and the valve assembly 104.

[0116] The opening and closing of the check valve 110 is generally referred to FIG. 2A to FIG. 2B describe. Figure 2A The one-way valve 110 is shown in a closed state, while Figure 2B The one-way valve 110 is shown in an open state. Figure 2A In the closed position shown, the pressure differential across valve 110 is such that P 1 ≤P 2 +P C , where P 1 is the pressure on the first side 132 of the one-way valve 110, P 2 is the pressure on the second side 134 of the one-way valve 110, and P C is the opening pressure of the one-way valve 110. Similarly, when the one-way valve 110 is in a state such as Figure 2B In the open position shown, the pressure differential across valve 110 is such that P 1 >P 2 +P C , where P 1 is the pressure on the first side 132 of the one-way valve 110, P 2 is the pressure on the second side 134 of the one-way valve 110, and P C is the opening pressure of the check valve 110. In this case, for P 1 >P 2 +P C , body fluid will flow from the first side 132 to the second side 134 through the one-way valve 110 .

[0117] In an example, the one-way valve 110 can be configured to have a low cracking pressure, such that the one-way valve is configured to switch from a closed state to an open state with a relatively small pressure difference across the one-way valve. For example, the cracking pressure of the one-way valve 110 can be about 25 cmH 2 O or less to about 5cmH 2 O or less, and as a specific example, the opening pressure of a given one-way valve may be less than about 25 cmH 2 O, less than about 15cmH 2 O, less than about 10cmH 2 O or less than about 5cmH 2 In addition, in an example, the one-way valve 110 can be configured to have a low resealing pressure, such that the one-way valve is configured to switch from an open state to a closed state with a small pressure differential across the one-way valve. For example, the resealing pressure of the one-way valve 110 can range from about 15 cmH 2 O or lower to about 2cmH 2 O or less, and as a specific example, the cracking pressure of a given one-way valve may be less than about 15 cmH 2 O, less than about 10cmH 2 O, less than about 5cmH 2 O or less than about 2 cmH 2 O.

[0118] In addition, the opening pressure and / or resealing pressure of the one-way valve 110 can be selected based on any of a variety of factors, examples of which can be the type of cavity from which the body fluid management system is intended to discharge body fluid, as well as other examples. For example, as one possibility, in the case where the pressure changes from low positive to low negative (e.g., pleural cavity), the opening pressure and / or resealing pressure can be maintained below the case where the pressure tends to remain positive (e.g., peritoneal cavity). As another possibility, in the case where the pressure in the cavity tends to remain positive but it is desired not to drop the body fluid volume to zero, the valve opening pressure can be selected at a level configured to keep the body fluid in the cavity. For example, for the cerebrospinal cavity, the cerebrospinal cavity tends to maintain a positive pressure, but it is desired not to drop the cerebrospinal fluid (CSF) to zero. Therefore, for the cerebrospinal cavity, the valve opening pressure can be set to a desired level that will prevent the body fluid pressure in the space from dropping below the desired opening pressure and keep the CSF in the cerebrospinal cavity.

[0119] In an example, the one-way valve 110 may include a plurality of lips defining a slit that may be moved from a closed position to an open position. FIG. 2A to FIG. 2BThe one-way valve 110 may include a first lip 202 and a second lip 204 defining a slit 206. The lips 202 and 204 may be configured such that when the lips are in the closed position, the interaction surface area between the lips is relatively small. For example, in one example, the interaction surface area is less than 60 mm. 2 , and preferably at 0.6 mm 2 Up to 6mm 2 The surface area within this range can help ensure that the check valve works well in both wet and dry conditions. As the interaction surface area of ​​the valve lip becomes larger (e.g., greater than 60mm 2 ), when the lip is wetted, significant cohesive and adhesive forces may develop between the liquid and the two surfaces, making the valve more difficult to open. The force required to separate the two surfaces of the valve lip is given by the relationship Given as F = the force required to separate the lips, T is the surface tension of the wetting liquid (T = 70 for water at 37°C), A is the area of ​​the interface between the lips, and h is the thickness of the liquid layer between the lips.

[0120] exist FIG. 2A to FIG. 2B In the example of FIG. 1 , the one-way valve 110 is formed as a duckbill valve. However, other types and / or shapes of valves are also possible, including, for example, flapper valves and cross-slit valves.

[0121] Additionally, in one example, the one-way valve 110 is configured such that when in an open state, the opening is larger than the lumen of the tube 116. This configuration can help ensure that any debris that may enter the tube can be cleared by the valve. In some examples, the opening at the proximal end 118 of the tube 116 is smaller than the lumen of the tube 116, the lumen of the tube 116 is smaller than the opening when the one-way valve 110 is in an open state, and the opening when the one-way valve 110 is in an open state is smaller than the lumen of the outlet 108. Other examples are also possible.

[0122] During operation of the bodily fluid management system 100, pressure fluctuations between the cavity 114 and the one-way valve 110 may cause the one-way valve 110 to open and close. In one example, the pressure fluctuations between the cavity 114 and the one-way valve 110 occur based on the breathing action of a person's breathing cycle. For example, when the cavity 114 is the pleural cavity, the pressure between the cavity 114 and the one-way valve 110 swings from positive to negative during the breathing cycle. Figure 3 1 shows exemplary pressure fluctuations that may occur between cavity 114 and one-way valve 110 during a breathing cycle. The pressure in the pleural cavity is not static and typically varies during normal breathing. Figure 3 As shown, pleural pressure (P 胸膜)300 swings relative to atmospheric pressure from slightly negative during inspiration to slightly positive during expiration. During inspiration, the external intercostal muscles contract causing the ribs and sternum to rise, and the diaphragm contracts, flattens, and presses downward on the abdominal contents. This combined action results in expansion of the chest cavity with a simultaneous decrease in pleural pressure, thereby expanding the elastic lungs. The abnormality during normal breathing is primarily a passive process that relies on elastic rebound. During expiration, the external intercostal muscles and diaphragm simply relax. As the external intercostal muscles relax, the elasticity of the expanded lungs causes them to rebound to their original position. This action causes the size of the chest cavity to decrease as pleural pressure increases.

[0123] Fluctuations in pleural pressure may be exacerbated in some circumstances, such as when a person breathes deeply and / or coughs. Based on these fluctuations in pressure between the cavity 114 and the one-way valve 110, the one-way valve 110 will close during inspiration (when the pressure is negative), and the one-way valve 110 will open during expiration (when the pressure is positive). In this way, the valve assembly 104 uses the energy provided by the breathing action of the person to provide a pumping action to discharge body fluid from the cavity 114, so that the one-way valve 110 can allow body fluid to flow from the cavity 114 to the outside during expiration and prevent backflow during inspiration. In particular, considering this opening and closing due to the breathing action, the valve assembly 104 can be used as a pump to move body fluid from the cavity 114 through the tube 116, through the one-way valve 110 and out of the outlet 108. In addition, since the pleural cavity moves from positive to negative in pressure instantaneously, the one-way valve 110 also prevents backflow because the valve assembly 104 provides a pumping action. When a person breathes in, the one-way valve 110 closes and thus acts as a check valve to prevent body fluids and / or air from entering the tube 116. On the other hand, when a person exhales, the pleural pressure increases and forces the body fluids to move forward.

[0124] An example draining process for draining the body cavity 114 is described below. Prior to draining the body cavity 114 using the bodily fluid management system 100, a person may first select an external reservoir in which to drain the bodily fluid from the cavity 114. Generally, a person may drain the bodily fluid into any suitable reservoir, such as a sink, toilet, and / or container provided by the person, etc. Additionally, prior to commencing draining, the valve assembly area may be cleaned with soap and water and / or decontaminated with alcohol, povidone iodine, or chlorhexidine, etc. Next, to initiate the draining process, a person may switch the adjustable outlet lock 112 to an unlocked position. When the adjustable outlet lock 112 is in the unlocked position, bodily fluid may begin to move through the bodily fluid management system 100. As described above, the one-way valve 110 may open and close based on pressure fluctuations between the cavity 114 and the one-way valve 110. In practice, when the adjustable outlet lock 112 is in the locked position, the one-way valve 110 is typically closed because typically P 1 ≤P 2 +P C .

[0125] Upon initially unlocking the adjustable outlet lock 112, bodily fluid may begin to move through the bodily fluid management system 100 due to the pressure of the body cavity 114 and / or the pumping action provided by the opening and closing of the one-way valve 110. This will cause the bodily fluid to move from the cavity 114, through the tube 116, through the one-way valve 110, and then out of the outlet 108 and into an external reservoir selected by the person. After the draining process has begun, the person may drain the bodily fluid from the cavity 114 until the cavity 114 is empty and / or a desired amount of bodily fluid has been drained from the cavity 114. Finally, after the draining is complete, the person may clean or decontaminate the outlet 108 and / or the adjustable outlet lock 112 and switch the adjustable outlet lock 112 to the locked position.

[0126] The bodily fluid management system 100 can also be designed so that when a sufficient amount of bodily fluid has moved through the bodily fluid management system 100, a siphon effect can be utilized to help drain the bodily fluid from the cavity 114 more quickly. For example, the bodily fluid management system 100 can be designed so that the pressure of the cavity 114 and / or the pumping action provided by the valve assembly 104 can allow a column of bodily fluid to form within the tube, which in turn causes a siphon effect. In other words, the bodily fluid management system 100 can be designed so that once the tube 116 is primed by the valve assembly 104 (e.g., based on respiration), the bodily fluid from the cavity 114 can be siphoned.

[0127] When conditions suitable for siphoning occur, the bodily fluid management system 100 can allow bodily fluid to be siphoned from the cavity 114. Generally, siphoning can occur when (i) the tube 116 has a sufficient column of bodily fluid in the tube 116 and (ii) the end of the column of bodily fluid is below the level of bodily fluid in the cavity 114, which provides a sufficient hydrostatic pressure gradient.

[0128] During drainage, a person may control the level of the outlet 108 in order to encourage the end of the column of bodily fluid to be below the level of the fluid in the cavity 114. Ensuring that the tube remains below the level of the fluid by a sufficient amount may facilitate siphoning during the drainage process.

[0129] The body fluid column required to produce the siphon effect can vary. In an example, a sufficient body fluid column can be a body fluid column with a length in the range of 10-100 centimeters (cm). In addition, a longer tube can provide a longer body fluid column, which in turn can provide a stronger siphon effect, and therefore provide a faster body fluid flow to discharge body fluid from cavity 114 more quickly. In an example, after starting siphoning during the discharge process, a person can continue to discharge body fluid from cavity 114 until cavity 114 is empty and / or removes a desired amount of body fluid from cavity 114. When siphoning occurs, the one-way valve 110 remains open. Finally, after the discharge is completed, the person can clean and / or decontaminate the outlet 108 and / or adjustable outlet lock 112 of the valve assembly 104, and move the adjustable outlet lock 112 to the locked position. In some examples, the one-way valve, tubing diameter, and / or tubing length can be selected to ensure a desired minimum flow rate, such as 25 milliliters per minute (ml / min), 50 ml / min, 75 ml / min, 100 ml / min, 150 ml / min, or greater, etc. Additionally or alternatively, the one-way valve (and associated cracking pressure), tubing length, and / or tubing diameter can be selected to prevent the pressure in the body fluid cavity from dropping below a desired level, such as 10 cmH. 2 O, 20cmH 2 O, -30cmH 2 O or -40cmH 2 0 or more negative, etc. In one example, for the pleural space, when the pressure is too low, the person may be in pain, experience coughing, and reports of "re-expansion pulmonary edema" occur when large volumes are discharged and / or the pressure is too low. Preventing the pressure in the body fluid cavity from dropping below the desired level can help avoid or reduce such problems.

[0130] In some examples, based on the breathing action of the person's breathing cycle, the cavity pressure of the cavity being discharged may tend to remain positive, rather than fluctuate from positive to negative. For example, the peritoneal cavity pressure relative to atmospheric pressure tends to remain positive throughout the breathing cycle. In this way, in an example where the body cavity being discharged is the peritoneal cavity, the pressure between the cavity 114 and the one-way valve 110 may tend to remain positive. In this case, the one-way valve 110 may not be routinely opened and closed to provide a pump action to move body fluid through the tube 116. On the contrary, in this case, when the adjustable outlet lock 112 is switched to the unlocked position, the positive peritoneal cavity pressure may tend to move body fluid forward throughout the tube and keep the one-way valve 110 open. However, in the case where the cavity pressure may tend to remain positive, pressure fluctuations may still occur due to various reasons that may cause the one-way valve 110 to close. For example, the cavity pressure may fluctuate to negative due to one reason or another. As a possibility, if the main body position and / or tip of the tube 116 are positioned so that the abdomen is below the tube outlet, the pressure may drop to negative. As another possibility, if the space (e.g., the peritoneal space) is diseased so that the intestine / abdominal wall does not expand / displace as the body fluid is discharged, a negative pressure may be generated. As yet another possibility, a large release of gas from the abdomen (volume shift) may instantaneously turn the pressure negative. Other examples are also possible. In such a case where the cavity pressure may tend to remain positive, but pressure fluctuations may still occur due to various reasons that may cause the one-way valve 110 to close, rather than providing a pumping action during the discharge process, the one-way valve 110 may instead be used primarily as a stop to ensure that if the pressure fluctuates to a negative pressure for some reason during the discharge process, the one-way valve 110 is closed to prevent backflow.

[0131] In the examples discussed above, the valve assembly 104 includes a single one-way valve. In other examples, the valve assembly 104 includes two one-way valves arranged in series, and the two one-way valves may allow for additional capabilities and / or benefits relative to a valve assembly having a single one-way valve. FIG. 4A to FIG. 4B An exemplary bodily fluid management system including a valve assembly having two one-way valves is further described.

[0132] Figure 4A An exemplary bodily fluid management system 100' is depicted, and Figure 4BA bodily fluid management system 100' is depicted implanted in a human body 102. The bodily fluid management system 100' includes a valve assembly 104' having an inlet 106 and an outlet 108, one-way valves 110' and 110", and an adjustable outlet lock 112. The one-way valves 110' and 110" are arranged in series and are housed in a pumping chamber 402 or on the proximal and distal ends of the pumping chamber 402. The one-way valves 110' and 110" are located between the inlet 106 and the outlet 108, and are each configured to open and close based on pressure fluctuations between a cavity 114 and the one-way valve. In addition, the one-way valve 110' is configured to open and close based on changes in the pressure of the cavity 114 and the pressure inside 403 of the chamber 402, and the one-way valve 110' is configured to open based on changes in the pressure inside 403 of the chamber 402 (which may vary based on the cavity pressure and the opening of the one-way valve 110') and atmospheric pressure. The body fluid management system 100' also includes a body fluid management tube 116 for transporting body fluid from the cavity 114 to the valve assembly 104'. The tube 116 is configured to extend from the inlet 106 to the cavity 114 and allow body fluid to move from the cavity 114 to the inlet 106 of the valve assembly 104. The tube 116 is implanted in the human body 102 so that the proximal end 118 of the tube 116 is positioned within the cavity 114 and the distal end 120 is positioned outside the human body 102. In addition, the valve assembly 104' is located outside the human body 102.

[0133] As described above, the one-way valves 110' and 110" are arranged in series and housed in the pumping chamber 402 or on the proximal and distal ends of the pumping chamber 402. In an example, the body 404 of the pumping chamber may form and / or house the one-way valve frames 130' and 130", which enclose the one-way valves 110' and 110', respectively, and provide structure and support to the one-way valves 110' and 110'. Figure 4A In the example of the one-way valve frame 130 'is integral with the tube 116. In other examples, the one-way valve frame 130 'can be used to connect to the distal end 120 of the tube 116 (e.g., to Figure 1A The one-way valve frame 130' may be sized and shaped to provide an engagement point or interconnectable joint to the tube 116. In an example, the valve assembly 104' is non-removably attached to the tube 116.

[0134] The valve assembly 104' can be used in the same manner as described with respect to FIG. Figure 3 The valve assembly 104 ′ operates in a similar manner to the valve assembly 104 described above. In addition, the valve assembly 104 ′ provides some additional capabilities for draining bodily fluid from the cavity 114. For example, relative to a valve assembly having a single one-way valve, the valve assembly 104 ′ can provide additional capabilities and / or benefits, including but not limited to improving the flow of bodily fluid movement in a bodily fluid management system and / or providing additional barriers to reverse flow, etc.

[0135] Turning first to operation in a manner similar to valve assembly 104, each of valves 110' and 110" may be operated in a manner similar to Figure 1A The one-way valve 110 operates in the same manner and has the same Figure 1A The one-way valve 110 has the same characteristics as the one-way valve 110. For example, each of the one-way valves 110' and 110" is configured to open and close based on pressure fluctuations between a cavity of the human body and the one-way valve. As an example, pressure fluctuations between cavity 114 and the one-way valves 110' and 110" (e.g., fluctuations that occur based on the breathing action of a person's breathing cycle) may cause the one-way valves 110' and 110" to open and close, thereby providing a pumping action to move body fluids. It is assumed that the one-way valves 110' and 110" are the same or similar to the one-way valve 110 in many respects, and therefore the one-way valves 110' and 110" will not be described in detail. However, it should be understood that any possibilities and permutations described with respect to the one-way valves 110' and 110' are also possible.

[0136] Turning next to the additional ability to generate bodily fluid movement in the bodily fluid management system 100', the pumping chamber 402 of the valve assembly 104' can be used to prime the system and move bodily fluid through the bodily fluid management system 100'. This dual valve configuration can allow a person to prime the bodily fluid management system, which can help speed up the draining process by moving bodily fluid through the bodily fluid management system more quickly, which in turn can cause the siphon effect to occur more quickly.

[0137] This priming of the fluid management system 100' may be useful in various situations. For example, if the pumping action provided by the breathing action is insufficient to move the body fluid and / or does not move the body fluid as quickly as a person would like, this priming of the system may be useful. As another example, if there is a low positive pressure between the cavity 114 and the one-way valves 110', 110' that is insufficient to move the body fluid and / or does not move the body fluid as quickly as a person would like, this priming of the system may be useful. As yet another example, if for some reason air is in the tube, this priming of the system may be useful. In tubes commonly found in catheter applications, a small amount of air can create enough surface tension to air lock the tube. The priming of the fluid management system 100' can help overcome this air lock that is created. As yet another example, if there is not enough body fluid static pressure gradient to provide a siphon effect, this priming of the fluid management system 100' may be useful. Other examples are also possible.

[0138] This dual valve configuration may also allow for the generation of supraphysiological pressures (positive through compression and negative through design of the resiliency of the pumping chamber 402), which may also be beneficial in clearing potential obstructions and / or debris from the fluid management system 100' (e.g., within tubing, from within a one-way valve, or from other areas of the valve assembly 104').

[0139] about FIG. 5A to FIG. 5D Priming of the bodily fluid management system 100 ′ using the pumping chamber 402 is further described. Figure 5A A cross-sectional schematic diagram of valve assembly 104' is shown in a generally or substantially non-compressed state, wherein both check valve 110' and check valve 110' are closed. For clarity, check valve 110' is also referred to herein as an "inlet check valve", and check valve 110' is referred to as an "outlet check valve". Inlet check valve 110' is positioned on a first side 501 of pumping chamber 402 proximate to the inlet of valve assembly 104', and outlet check valve 110' is positioned on a second side 503 of pumping chamber 402 proximate to the outlet 108 of valve assembly 104.

[0140] Figure 5B A cross-sectional schematic diagram of the valve assembly 104' is shown in a generally or substantially compressed state. In an example, as shown, a first force 502 can act on a first wall 504, causing the first wall 504 to collapse toward an interior space 506. Accordingly, a second force 508 can additionally or alternatively act on a second wall 510, causing the second wall 510 to collapse toward the interior space 506.

[0141] The first force 502 and the second force 508 can be applied to the pumping chamber 402 in any suitable manner. As one possibility, a person using the bodily fluid management system 100' can provide the force by manually compressing the pumping chamber with their fingers. As another possibility, the valve system 104' can include an electromechanical actuator configured to apply the forces 502 and 508. For example, the valve assembly 104' can include a piezoelectric diaphragm connected to the body of the pumping chamber 402. The piezoelectric diaphragm can be activated and deactivated by a controller, and both the piezoelectric diaphragm 540 and the controller 530 can be powered, for example, by a battery. As another example, the valve assembly 104' can include a piston or cam configured to apply the forces 502 and 508 to the pumping chamber 402. Other example methods and systems for applying the forces 502 and 508 are also possible.

[0142] The collapse of the first wall 504 and / or the second wall 510 serves to reduce the volume of the interior space 506 and increase the pressure in the interior space 506. This increase in pressure causes the inlet check valve 110' to remain closed and causes the outlet check valve 110' to open, and bodily fluid located in the interior space 506 flows from the interior space 506 through the outlet check valve 110' and out of the outlet 108. For incompressible bodily fluid, the change in volume experienced by the interior space 506 in response to the collapse of the first wall 504 and / or the second wall 510 will be approximately equal to the volume of bodily fluid that moves from the interior space 506 through the outlet check valve 110". As the bodily fluid moves from the interior space 506 through the outlet check valve 110", the pressure in the interior space 506 will decrease. Once the internal pressure is equal to or substantially equal to the pressure in the outlet 108, the flow will cease and the outlet check valve 110" will close, as shown in FIG. Figure 5C shown.

[0143] As described above, the body of the pumping chamber 402 may be substantially resiliently flexible so that, when placed in a position such as Figure 5B and Figure 5C After the compressed state shown, when at least one of the first force 502 and the second force 508 is removed, the valve assembly 104' will return to the state shown. Figure 5D When the first wall 504 returns to its uncompressed state as the first force 502 is removed and / or the second wall 510 returns to its uncompressed state as the second force 508 is removed, the volume of the interior space 506 increases and the pressure in the interior space 506 decreases. The pressure within the interior space 506 eventually drops below the pressure on the inlet 501 near the inlet check valve 110' and causes the inlet check valve 110' to open and body fluid located in the inlet to flow into the interior space 506. In this manner, the valve assembly 104' acts as a pump that generally draws body fluid from the inlet 501 and delivers it to the outlet 108.

[0144] In some examples, the pumping chamber 402 can be made of a material that allows the pumping chamber 402 to be compressed and then freely return to its original state. The pumping chamber 402 can be made of any suitable material. For example, the pumping chamber 402 can be an elastic flexible tube or cylinder made of polyurethane, silicon copper, polyvinyl chloride or latex. Alternatively, the pumping chamber 402 can be made of a combination of two or more materials, wherein at least one of the component materials provides elasticity and at least one of the component materials provides body fluid containment. For example, the pumping chamber 402 can be composed of elastic nitinol, steel, polyester fiber or other elastic components that provide elasticity and a second body fluid inhibition component (containment component) (such as polyurethane, silicone, polyvinyl chloride, latex rubber, polyethylene terephthalate (polyvinyl chloride), nylon, polytetrafluoroethylene (polytetrafluoroethylene), PEBAX, etc.) that provides body fluid containment in the pumping chamber 402. In other examples, such as those in which valve assembly 104' includes an electromechanical actuator (e.g., a piezoelectric diaphragm, piston, or cam configured to apply forces 502 and 508 to pumping chamber 402), the material can be flexible but not elastic (or have limited elasticity) because the electromechanical actuator can provide both active compression and active rarefaction.

[0145] Turning next to additional barriers to reverse flow, the addition of a second one-way valve provides another barrier to reverse flow. Figure 1A In the example of FIG. 1 , the one-way valve 110 provides a barrier to reverse flow, while Figure 4A In the example of , each of the one-way valves 110 ′ and 110 ″ provides a barrier to reverse flow. This additional barrier to reverse flow can provide enhanced protection against reverse flow.

[0146] To prevent clogging or blockage of the disclosed fluid management system, one or more components of the fluid management system can be coated with an anticoagulant factor or a fibrinolytic factor. For example, components or surfaces of the valve assembly 104, 104' and / or the implant tube 116 can be at least partially coated with an anticoagulant factor or a fibrinolytic factor. For example, referring to Figure 1A , the interior portion of the body 140 of the valve assembly 104, the one-way valve 110 and / or the interior portion of the tube 116 may be coated with an anticoagulant factor or a fibrinolytic factor. Figure 4A , the interior portion of the pumping chamber 402, the one-way valves 110' and 110" and / or the interior portion of the tube 116 can be coated with an anticoagulant factor or a fibrinolytic factor. Other components can also be coated with an anticoagulant factor or a fibrinolytic factor.

[0147] The presence of anticoagulant factors can reduce the amount of clotting that would occur if they were not present. Examples of anticoagulant factors include heparin, low molecular weight heparin, fondaparinux, idraparinux, idrabiotaparinux, dabigatran, rivaroxaban, apixan, betrixaban, edoxaban, darexaban, letaxaban, eribaxaban, hirudin, lepirudin, and lepirudin. In some embodiments, the present invention relates to a kind of fibrinolytic factor.In, bivalirudin, argatroban, dabigatran, ximelagatran, heme (hementin), vitamin E, coumarin (coumarin), warfarin (warfarin), acenocoumarol (acenocoumarol), phenprocoumon (phenprocoumon), atromentin (atromentin), phenindione (phenindione), brodifacoum (brodifacoum) and difenacoum (difenacoum).The example of fibrinolytic factor comprises plasmin (plasmin), tissue plasminogen activator (tissue plasminogen activator), urokinase (urokinase), streptokinase (streptokinase), plasminogen activator inhibitor-1 inhibitor (plasminogen activator inhibitor-1inhibitor) and plasminogen activator inhibitor-2 inhibitor (plasminogen activator inhibitor-2inhibitor). Other examples of anticoagulant factors or fibrinolytic agents may be used.

[0148] In at least some implementations of valve assembly 104' having pumping chamber 402, one-way valves 110' and 110" can each be configured to have a low "cracking pressure" such that the one-way valves are configured to transition from a closed state to an open state with a relatively small pressure differential across the one-way valves. For example, the cracking pressure of each one-way valve can be about 25 cmH. 2 O or less to about 5cmH 2 O or less, and as a specific example, the opening pressure of a given one-way valve may be less than about 25 cmH 2 O, less than about 15cmH2 O, less than about 10cmH 2 O or less than about 5cmH 2 In addition, in at least some implementations, the one-way valves 110' and 110" can each be configured to have a low "reseal pressure" such that the one-way valves are configured to switch from an open state to a closed state with a small pressure differential across the one-way valves. For example, the reseal pressure of each one-way valve can be about 15 cmH. 2 O or less to about 2 cmH 2 O or less, and as a specific example, the opening pressure of a given one-way valve may be less than about 15 cmH 2 O, less than about 10cmH 2 O, less than about 5cmH 2 O or less than about 2 cmH 2 O. In other implementations of the valve assembly 104' having the pumping chamber 402, the opening and / or resealing pressures of the check valves 110' and 110' may be higher.

[0149] The pumping chamber 402 is described with reference to an example in which the one or more one-way valves take the form of two one-way valves arranged in series. In some examples in which the valve assembly 104 includes a single one-way valve, the valve assembly 104 may also include a compressible chamber positioned on the inlet side or outlet side of the single one-way valve, such as between the single one-way valve and a small narrowing in the lumen of the flow path, which may provide hydrostatic resistance. Such a compressible chamber may be used to help initiate the flow of bodily fluids and / or enhance or allow a pumping action.

[0150] As mentioned above, in Figure 1A In the example of FIG. 1 , the adjustable outlet lock 112 takes the form of a cover, but various adjustable outlet locks 112 are possible. As one possibility, the adjustable outlet lock 112 can take the form of a pinch lever. For example, referring to FIG. FIG. 6A to FIG. 6B The adjustable exit lock 112 may include a rod 600 positioned at the exit 108, the rod 600 being adjustable to be positioned in (i) a locked position 602 (see Fig. 6A ) and (ii) unlocked position 606 (see Figure 6B ) in a locked position 602 in which the rod 600 pinches the tube 604 of the outlet 108 to seal the outlet 108, and in an unlocked position 606 in which the rod 600 no longer pinches the tube 604, thereby allowing the tube 604 to open and thereby allow body fluids to move through the outlet 108.

[0151] As another possibility, the adjustable exit lock 112 may take the form of a twist pinch. FIG. 7A to FIG. 7BThe adjustable outlet lock 112 may include a pinch piece 700 positioned at the outlet 108, which can be adjusted to be in (i) a locked position 702 (see Fig. 7A ) and (ii) an unlocked position 706, wherein the pinch member 700 pinches the tube 704 of the outlet 108 to seal the outlet 108, and in the unlocked position 706, the pinch member 700 no longer pinches the tube 704, thereby allowing the tube 704 to open and thereby allow body fluids to move through the outlet 108.

[0152] As yet another possibility, the adjustable outlet lock 112 may take the form of a twist cap that activates a pinch arm. FIG. 8A to FIG. 8D The adjustable outlet lock 112 may include a twist cover 800 positioned at the outlet 108, the twist cover 800 being adjustable so that the twist cover 800 is in (i) a locked position 802 (see Figure 8C and Fig.8D , which is along Figure 8C 8D-8D in FIG. 8B ) and (ii) an unlocked position 806 (see FIG. 8C ). Fig. 8A and Figure 8B , which is along Fig. 8A 8B-8B in the cross-sectional view of the adjustable outlet lock 112), in which the twist cap 800 forces the pinch arms 808 to pinch the tube 804 of the outlet 108 to seal the outlet 108, and in the unlocked position 806, the twist cap 800 allows the pinch arms 808 to flex outward, thereby allowing the tube 804 to open and thereby allow body fluids to move through the outlet 108. 9A to 9C Another example twist cap for activating the pinch arm is shown in FIG. As shown, the adjustable outlet lock 112 may include a threaded twist cap 900 positioned at the outlet 108 that can be adjusted so that the threaded twist cap 900 is in (i) a locked position 902 (see FIG. Fig. 9C ) and (ii) unlocked position 906 (see Fig. 9B ), in a locked position 902, the threaded twist cap 900 forces the pinch arms 908 to pinch the tube 904 of the outlet 108 to seal the outlet 108, and in an unlocked position 906, the threaded twist cap 900 allows the pinch arms 908 to flex outwardly, thereby allowing the tube 904 to open and thereby allow body fluids to move through the outlet 108. Fig. 9C As shown in FIG. 1 , there is a partially tapered connector on the inside of the twist cap 900 that engages the pinch arm 908 when the twist cap 900 is screwed all the way on, thereby closing the pinch arm 908. In addition, when the twist cap is partially unscrewed (see FIG. 1 ), the pinch arm 908 is closed. Fig. 9B ), the partially tapered connector on the inner side of the twist cap 900 disengages and releases the pinch arm 108. In addition, as FIG. 9A to FIG. 9BAs shown, when the inner portion of the twist cap 900 is disengaged and the pinch arm 108 is released (see Fig. 9B ), the tube 904 can be opened, and as the unscrewing continues, the twist cap 900 can be completely disengaged from the pinch arm 908 (see Fig.9A ).

[0153] As yet another possibility, the adjustable exit lock 112 may take the form of a biasing device. FIG. 10A to FIG. 10B , the adjustable exit lock 112 may include a biasing device 1000 positioned at the exit 108, which may be adjusted to be in (i) a locked position 1002 (see Fig. 10A ) and (ii) unlocked position 1006 (see Fig. 10B ) in the locked position 1002, the offset device 1000 blocks the outlet 108 so as to seal the outlet 108, and in the unlocked position 1006, the offset device 1000 no longer blocks the outlet 108, thereby allowing body fluids to move through the outlet 108.

[0154] FIG. 11A to FIG. 11B 104 ′. In this example, the adjustable outlet lock 112 takes the form of a removable locking cover 1100 positioned at the outlet 108, which can be adjusted to be in (i) a locked position 1102 (see Fig.11A ) and (ii) an unlocked position 1106, wherein in the locked position 1102, the removable locking cover 1100 blocks the outlet 108 so as to seal the outlet 108, and in the unlocked position 1106, the removable locking cover 1100 no longer blocks the outlet 108, thereby allowing body fluids to move through the outlet 108.

[0155] FIG. 12A to FIG. 12B 104 ′. In this example, the adjustable outlet lock 112 takes the form of a rotatable locking valve 1200 positioned at the outlet 108, which can be adjusted to be in (i) a locked position 1202 (see Fig. 12A ) and (ii) an unlocked position 1206, wherein in the locked position 1202, the rotatable locking valve 1200 blocks the outlet 108 so as to seal the outlet 108, and in the unlocked position 1206, the rotatable locking valve 1200 no longer blocks the outlet 108, thereby allowing body fluids to move through the outlet 108.

[0156] Other exemplary adjustable outlet locks are possible, including, for example, ball valves and stop-cocks and external clamps, etc. In addition, in examples where the adjustable outlet lock includes a removable cap, the valve assembly 104 may also include a tether for the removable cap so that when a person drains bodily fluids from the cavity 114 and the removable cap is in the unlocked position, the removable cap remains attached to the valve assembly 104.

[0157] As described above, a person can drain bodily fluid from cavity 114 until cavity 114 is empty and / or a desired amount of bodily fluid has been drained from the cavity. The amount of bodily fluid drained using bodily fluid management system 100 can depend on various factors, such as the cavity drained, the amount of bodily fluid drained in the cavity, the amount of time available for draining, the recommended amount of bodily fluid to be drained, etc., etc. In one example, when draining the pleural cavity, a person can drain approximately 100 to 200 milliliters per day. In another example, when draining the peritoneal cavity, a person can drain approximately 0.75 to 1.25 liters per day. Other examples are also possible.

[0158] As described above, the disclosed bodily fluid management system 100 can be kept with a person at all times. When the person is not draining a body cavity, the person can secure the external portion of the bodily fluid management system to the person's body. For example, the external portion of the bodily fluid management system can be secured to the person (e.g., via an appropriate securing mechanism, such as a gauze pad and / or medical tape, etc.), such as Fig.13 The external portion 117 of the fluid management system 100 is shown. In some examples, a person can wrap the external portion of the implant so that the external portion of the fluid management system can be secured to the person (e.g., via an appropriate securing mechanism, such as a gauze pad and / or medical tape, etc.). For example, Fig.14 An example of such a coil is depicted. In particular, when the person is not draining the body cavity, the person can coil the outer portion of the implant tube 116 so that the outer portion 117 of the fluid management system 100 can be fixed to the person. In the case where the outer portion of the implant tube can be coiled, the size and shape of the geometric structure of the valve assembly 104 and / or the pumping chamber 402 can be designed to facilitate positioning within the coiled implant tube 116 and / or minimize the profile of the fixed fluid management system.

[0159] also, FIG. 15A to FIG. 15B Another example of winding is depicted. Specifically, Fig.15A An exemplary bodily fluid management system 100 is shown, and Fig. 15B An exemplary arrangement of the external portion 117 of the bodily fluid management system is shown. Fig.15A, the bodily fluid management system 100 includes a tube 116 for transporting bodily fluid from a body cavity of a person to a valve assembly 104 and an outer tube 142. In this example, the tube 116 can be inside or substantially inside the body of the person, while the valve assembly 104 (including the outer tube 142) can be outside the body of the person. In this case, when the person is not emptying the body cavity, the person can roll up the outer tube 142 so that the outer portion 117 of the bodily fluid management system 100 can be fixed to the person. In the case where the outer tube can be rolled up, the size and shape of the geometric structure of the valve assembly 104 and / or the pumping chamber 402 can be designed to facilitate positioning within the rolled outer tube 142 and / or minimize the profile of the fixed bodily fluid management system.

[0160] In some examples, valve assembly 104 or valve assembly 104' can be connected to an indwelling catheter, such as an indwelling pleural catheter. To facilitate attachment to an indwelling catheter, valve assembly 104 or valve assembly 104' can include an attachment mechanism for attachment to the indwelling catheter. Fig.16 and Fig.17 Two examples of connecting an exemplary bodily fluid management system including a valve assembly 104' to an indwelling catheter are shown.

[0161] First go to Fig.16 , Fig.16 An exemplary process for connecting a valve assembly 104' to an indwelling catheter 1602 is shown. The indwelling catheter 1602 includes a locking cap 1604. The locking cap 1604 can be removed, thereby exposing a distal end 1606 of the indwelling catheter 1602. The valve assembly 104' can include (i) an adjustable outlet lock 112 on the distal end of the valve assembly 104' and (ii) an attachment system 1608 on the proximal end of the valve assembly 104'. The attachment system 1608 is configured to attach to the distal end 1606 of the indwelling catheter. Any suitable attachment system for connecting to the distal end 1606 is possible. In an example, a person can engage the attachment system 1608 with the distal end 1606 and twist the valve assembly 104' and / or the attachment system 1608 so that the attachment system 1608 is connected to the distal end 1606. After connecting the valve assembly 104' to the indwelling catheter 1602, the user can control the adjustable outlet lock 112 (e.g., as Fig.16 The adjustable outlet lock 112 is opened and closed as shown to discharge body fluids from the body cavity as needed.

[0162] Next go to Fig.17 , Fig.17An exemplary process for connecting a valve assembly 104' to an indwelling catheter 1702 is shown. In this example, the indwelling catheter 1702 may be damaged and leak (e.g., through a slit 1703 in the indwelling catheter 1702). The indwelling catheter 1702 may be pinched near the person in whom the indwelling catheter 1702 is implanted, and then the indwelling catheter 1702 may be cleanly cut to remove the damaged section having the slit 1703. The valve assembly 104' may include (i) an adjustable outlet lock 112 at the distal end of the valve assembly 104' and (ii) an attachment system 1708 at the proximal end of the valve assembly 104'. The attachment system 1708 is configured to attach to the distal end 1706 of the tubing of the indwelling catheter 1702. Any suitable attachment system for connecting to the distal end 1706 of the tubing is possible. In one example, the attachment system 1708 may be configured to provide an interference fit with the distal end 1706 of the tubing of the indwelling catheter 1702. However, other attachment systems are possible.After connecting the valve assembly 104' to the indwelling catheter 1702, the user can control the adjustable outlet lock 112 (eg, open and close the adjustable outlet lock 112) to drain bodily fluids from the body cavity as desired.

[0163] Also provided are exemplary methods for facilitating the discharge of body fluids from a body cavity and for discharging body fluids from a body cavity. Such methods may be, for example, described with reference to FIGS. Fig.17 The bodily fluid management system 100 or 100 ′ is described and / or implemented using the bodily fluid management system 100 or 100 ′.

[0164] Fig.18 A flow chart of an example method 1800 of bodily fluid management is shown. It should be understood that for this and other processes and methods disclosed herein, the flow chart illustrates the functionality and operation of one possible implementation of the present embodiment. Alternative implementations are included within the scope of the example embodiments of the present disclosure, where functions may be performed out of the order shown or discussed, including substantially simultaneously or in reverse order, depending on the functions involved, as will be understood by those skilled in the art.

[0165] At box 1802, method 1800 involves providing a body fluid management system for selectively draining body fluid from a body cavity. The body fluid management system includes a valve assembly and a tube for conveying body fluid from a body cavity of a person to the valve assembly, wherein the valve assembly is configured to be positioned outside the human body and includes: (i) an inlet; (ii) an outlet; (iii) one or more one-way valves positioned between the inlet and the outlet, each one-way valve being configured to open and close based on pressure fluctuations between the body cavity of the person and the one-way valve; and (iv) an adjustable outlet lock configured to selectively prevent body fluid from moving through the outlet. At box 1804, method 1800 involves implanting a portion of the body fluid management system into a human body, such that a proximal end of the tube is in fluid communication with the cavity, and the valve assembly is positioned outside the human body. At box 1806, after the body fluid management system is implanted in the human body, as described above, the person can use the body fluid management system to selectively drain body fluid from the body cavity.

[0166] Fig.19 A flow chart of an exemplary method 1900 for discharging bodily fluid from a body cavity of a person to a reservoir outside the person is shown. Specifically, method 1900 is a method of operating a bodily fluid management system, the bodily fluid management system including a valve assembly and a tube for conveying bodily fluid from a body cavity of a person to the valve assembly, wherein the valve assembly is configured to be positioned outside the body of the person and includes: (i) an inlet; (ii) an outlet; (iii) one or more one-way valves positioned between the inlet and the outlet, each one-way valve being configured to open and close based on pressure fluctuations between the body cavity of the person and the one-way valve; and (iv) an adjustable outlet lock configured to selectively prevent bodily fluid from moving through the outlet. At box 1902, method 1900 involves an adjustable outlet lock preventing bodily fluid from moving through the outlet when the adjustable outlet lock is in a locked position. At block 1904, method 1900 involves, when the adjustable outlet lock is in the unlocked position, each of the one or more one-way valves opening and closing based on pressure fluctuations between the body cavity of the person and the one-way valves to provide a pumping action to move body fluid from the body cavity through the tube, into the inlet, and out of the outlet to the external reservoir. The fluctuations may occur based on the breathing action of the person's breathing cycle.

[0167] Fig. 20A flow chart of an exemplary method 2000 for discharging bodily fluid from a body cavity of a person to a reservoir outside the person is shown. Specifically, method 2000 is a method of operating a bodily fluid management system, the bodily fluid management system including a valve assembly and a tube for conveying bodily fluid from a body cavity of a person to the valve assembly, wherein the valve assembly is positioned outside the person and includes: (i) an inlet; (ii) an outlet; (iii) a plurality of one-way valves positioned between the inlet and the outlet and each configured to open and close based on pressure fluctuations between the body cavity of the person and the one-way valve, wherein the plurality of one-way valves are housed in a pumping chamber; and (iv) an adjustable outlet lock configured to selectively prevent bodily fluid from moving through the outlet.

[0168] At box 2002, method 2000 involves attaching an external portion of a bodily fluid management system to a human body while an adjustable outlet lock is in a locked position. In an example, the bodily fluid management system is attached to a chest wall of a person. At box 2004, method 2000 involves compressing and decompressing a pumping chamber when the adjustable outlet lock is in an unlocked position to provide a pumping action to prime the bodily fluid management system and move bodily fluid through the bodily fluid management system. Additionally, at box 2006, method 2000 involves siphoning bodily fluid from a body cavity through the bodily fluid management system after the bodily fluid management system is primed and when the pumping chamber is positioned below a fluid level in the body cavity while the adjustable outlet lock is in the unlocked position. The bodily fluid may be discharged to a reservoir external to the human body. In an example, Figure 4B In , the pumping chamber 402 is shown as being positioned below the liquid level in the body cavity. However, in other examples, the tube may be longer and may be positioned further below the liquid level in the body cavity.

[0169] FIG. 21A to FIG. 21C An exemplary bodily fluid management system 2100 is depicted, and Fig.21D A bodily fluid management system 2100 is depicted implanted in a human body 2102. The bodily fluid management system 2100 includes a valve assembly 2104 having an inlet 2106, an outlet 2108, a pumping chamber 2110 between the inlet 2106 and the outlet 2108 and configured to be compressed and decompressed to pump bodily fluid, a first one-way valve 2112 (see FIG. 2 ) positioned on a first side 2114 of the pumping chamber 2110 (e.g., an end of the pumping chamber 2110 proximal to the inlet 2106). FIG. 21B to FIG. 21C ), a second one-way valve 2116 (see FIG. 21 ) positioned on a second side 2118 of the pumping chamber 2110 (eg, an end of the pumping chamber 2110 proximal to the outlet 2108) FIG. 21B to FIG. 21C ), and an adjustable inlet lock 2120 configured to selectively prevent body fluids from moving through the inlet 2106.

[0170] The body fluid management system 2100 also includes a body fluid management tube 2122 for transferring body fluid from a body cavity 2124 (see Fig.21D ) is delivered to the valve assembly 2104. The tube 2122 is configured to extend from the inlet 2106 to the body cavity 2124 and allow body fluid to move from the body cavity 2124 to the inlet 2106 of the valve assembly 2104. The tube 2122 is implanted in the human body 2102 so that the proximal end 2126 of the tube 2122 is positioned within the body cavity 2124 and the distal end 2128 is positioned outside the human body 2102. In addition, the valve assembly 2104 is positioned outside the human body 2102.

[0171] In some examples, the tube 2122 can have a cuff along its length that can be placed within the tissue of the human body 2102 near the exit of the tube 2122 from the human body 2102. Such a cuff can be, for example, made of fibers made of a material that allows tissue to grow inward into the fibers of the cuff, forms a barrier to bacterial entry, and helps to secure the tube 2122 in place over time. For example, such a cuff can be made of a material such as polyethylene terephthalate. In addition, in some examples, the tube 2122 can have features along its length that are configured to allow the tube to be secured to the human body 2102 using suture material.

[0172] The body cavity 2124 may be a cavity within the human body 2102 that may accumulate bodily fluids that are desired or required to be selectively drained from the body. FIG. 21A to FIG. 21D In the example of the present invention, the body cavity 2124 is the pleural cavity of the human body 2102. However, other body cavities are possible, such as the peritoneal cavity, the cerebrospinal cavity, the pericardial cavity, the breast cavity, or the cavity of a cystic lesion.

[0173] Each of the first check valve 2112 and the second check valve 2116 is configured to open and close based on the compression and decompression of the pumping chamber 2110. FIG. 22A to FIG. 22D The compression and decompression of the pumping chamber 2110 are further described. Specifically, Fig.22A A schematic cross-sectional view of the pumping chamber 2110 of the valve assembly 2104 in a generally or substantially uncompressed state is shown, wherein both the first one-way valve 2112 and the second one-way valve 2116 are closed. For clarity, the first one-way valve 2112 is also referred to herein as the "inlet one-way valve", and the second one-way valve 2116 is referred to as the "outlet one-way valve". The inlet one-way valve 2112 is positioned on a first side 2114 of the pumping chamber 2110 proximate the inlet of the valve assembly 2104, and the outlet one-way valve 2116 is positioned on a second side 2118 of the pumping chamber 2110 proximate the outlet 2108 of the valve assembly 2104.

[0174] Fig. 22BA cross-sectional schematic diagram of a valve assembly 2104 in a generally or substantially compressed state is shown. In an example, as shown, a first force 2202 can act on a first wall 2204, causing the first wall 2204 to collapse toward an interior space 2206. Accordingly, a second force 2208 can additionally or alternatively act on a second wall 2210, causing the second wall 2210 to collapse toward the interior space 2206.

[0175] The first force 2202 and the second force 2208 can be applied to the pumping chamber 2110 in any suitable manner. As one possibility, a person using the body fluid management system 2100 can supply the force by manually compressing the pumping chamber with their fingers. As another possibility, the valve assembly 2104 may include an electromechanical actuator configured to apply the forces 2202 and 2208. For example, the valve assembly 2104 may include a piezoelectric diaphragm connected to the body of the pumping chamber 2110. The piezoelectric diaphragm can be activated and deactivated by a controller, and both the piezoelectric diaphragm and the controller can be powered, for example, by a battery. As another example, the valve assembly 2104 may include a piston or cam configured to apply the forces 2202 and 2208 to the pumping chamber 2110. Other example methods and systems for applying the forces 2202 and 2208 are also possible.

[0176] The collapse of the first wall 2204 and / or the second wall 2210 serves to reduce the volume of the interior space 2206 and increase the pressure in the interior space 2206. This increase in pressure causes the inlet check valve 2112 to remain closed and causes the outlet check valve 2116 to open, and the body fluid located in the interior space 2206 flows from the interior space 2206 through the outlet check valve 2116 and out of the outlet 2108 (see FIG. 21B to FIG. 21C ). For incompressible bodily fluids, the change in volume experienced by the interior space 2206 in response to the collapse of the first wall 2204 and / or the second wall 2210 will be approximately equal to the volume of bodily fluid that moves from the interior space 2206 through the outlet check valve 2116. As bodily fluid moves from the interior space 2206 through the outlet check valve 2116, the pressure in the interior space 2206 will decrease. Once the internal pressure is equal to or substantially equal to the pressure in the outlet 2108, the flow will cease and the outlet check valve 2116 will close, as shown in FIG. Fig. 22C shown.

[0177] In some examples, the opening pressure and resealing pressure of each of the inlet check valve 2112 and the outlet check valve 2116 can be the same as or similar to the opening pressure and resealing pressure of the check valve 110, the check valve 110' and / or the check valve 110" (therefore, the opening pressure and resealing pressure of each of the inlet check valve 2112 and the outlet check valve 2116 are not described in detail). However, it should be understood that any possibilities and permutations described with respect to the opening pressure and resealing pressure of the check valve 110, the check valve 110' and / or the check valve 110' with respect to the opening pressure and resealing pressure of each of the inlet check valve 2112 and the outlet check valve 2116 are also possible.

[0178] As described above, the body of the pumping chamber 2110 may be substantially resiliently flexible so that, when placed in a position such as Fig. 22B and Fig. 22C After the compressed state shown, when at least one of the first force 2202 and the second force 2208 is removed, the valve assembly 2104 will return to the state shown. Fig.22A and Fig.22D As the first wall 2204 returns to its uncompressed state as the first force 2202 is removed and / or the second wall 2210 returns to its uncompressed state as the second force 2208 is removed, the volume of the interior space 2206 increases and the pressure in the interior space 2206 decreases. The pressure within the interior space 2206 eventually drops sufficiently below the pressure on the inlet 2106 near the inlet check valve 2112 and causes the inlet check valve 2112 to open and body fluid located in the inlet to flow into the interior space 2206. In this manner, the valve assembly 2104 acts as a pump that generally draws body fluid from the inlet 2106 and delivers it to the outlet 2108.

[0179] In some examples, the pumping chamber 2110 can be made of a material that allows the pumping chamber 2110 to be compressed and then freely return to its original state. The pumping chamber 2110 can be made of any suitable material. For example, the pumping chamber 2110 can be a resilient flexible tube, a cylinder, or other suitable shape made of polyurethane, silicone, polyvinyl chloride, or latex rubber. Alternatively, the pumping chamber 2110 can be made of a combination of two or more materials, wherein at least one of the component materials provides elasticity and at least one of the component materials provides bodily fluid containment. For example, the pumping chamber 2110 can be made of an elastic nitinol, steel, polyester, or other elastic component that provides elasticity and a second bodily fluid inhibiting component (such as polyurethane, silicone, polyvinyl chloride, latex rubber, polyethylene terephthalate, nylon, polytetrafluoroethylene, polyether block amide, such as In other examples, such as those in which the valve assembly 2104 includes an electromechanical actuator (e.g., a piezoelectric diaphragm, piston, or cam configured to apply forces 2202 and 2208 to the pumping chamber 2110), the material can be flexible but not elastic (or have limited elasticity) because the electromechanical actuator can provide both active compression and active rarefaction.

[0180] In some examples, the first one-way valve 2112 and the second one-way valve 2116 each have the ability to open a certain amount so that the cross-sectional area of ​​the passage through the one-way valve in the open position is greater than the cross-sectional area of ​​the lumen of the inlet 2106, so that any debris that may be able to enter the inlet 2106 and / or the tube 2122 can pass through the one-way valve.

[0181] In the example, the adjustable inlet lock 2120 is positioned upstream (along arrow 2150 (see FIG. Fig. 21B ) direction). For example, refer to Fig. 21B , the first one-way valve 2112 can be positioned within the pumping chamber 2110 at position 2132, and the adjustable inlet lock 2120 is located upstream of the first one-way valve 2112 at position 2134 (in the direction of arrow 2150).

[0182] exist FIG. 22A to FIG. 22D In the example of , the adjustable inlet lock 2120 is shown as a twist lock configured to pinch the tube 2122 and / or the inlet 2106. For example, FIG. 21A to FIG. 21B The adjustable inlet lock 2120 is shown in a closed position (eg, with the twist lock pinching the tube 2122 positioned at the inlet 2106), and Fig. 21C and FIG. 23A to FIG. 23B The adjustable inlet lock 2120 is shown after it has been rotated in direction 2302 to be in an open position (e.g., where the twist lock no longer pinches the tube 2122 of the inlet 2106). Rotation can move the twist lock from the closed position to the open position. Additionally, rotation in the opposite direction 2304 moves the adjustable inlet lock 2120 from the open position to the closed position. FIG. 21A to FIG. 22D The twist lock is similar to the reference FIG. 8A to FIG. 8D The twist cap functions in the manner described (eg, is configured to activate a pinch arm to pinch the tube 2122 at the inlet 2106), and thus will not be described in detail.

[0183] Despite FIG. 21A to FIG. 21D In the example of the adjustable entry lock 2120, the adjustable entry lock 2120 takes the form of a twist lock, but various adjustable entry locks 2120 are possible. For example, the adjustable entry lock 2120 can take the form of a pinch, a pinch level, and an offset device (e.g., similar to FIG. 6A to FIG. 6B , 7A to Figure 7B , 9A to Fig. 9C and 10A to Fig. 10B The form of the exit lock shown in ) and so on.

[0184] refer to Fig.21D and FIG. 24A to FIG. 24D Describes the operation of the body fluid management system 2100. To initiate the draining process, a person may first select an external reservoir 2402 (see Fig.24C ), wherein bodily fluids are discharged from the body cavity 2124. Generally, the person can discharge the bodily fluids into any suitable reservoir, such as a sink, toilet, and / or container provided by the person, etc. In addition, before initiating the discharge, the valve assembly area can be cleaned with soap and water and / or decontaminated with alcohol, povidone iodine or chlorhexidine, etc. In some examples, when the valve assembly is closed (and / or when also open), there is a gap so that if alcohol or soap and water is poured onto the locking portion and / or outlet portion of the bodily fluid management system (or if the portion is poured into such bodily fluids), the alcohol or soap and water can easily flow between the locking mechanism and the outlet conduit to provide more thorough decontamination. Next, to initiate the discharge process, the person can point upward at the outlet 2108 and switch the adjustable inlet lock 2120 to the unlocked position (see Fig.24A ).

[0185] With outlet 2108 pointing upward and adjustable inlet lock 2120 in the unlocked position, a person can alternately compress and decompress pumping chamber 2110 until pumping chamber 2110 is filled or substantially filled with body fluid (with the same Fig.24A In comparison, see Fig. 24B ). When the pumping chamber 2110 is full or substantially full of body fluid, the person can then point the outlet 2108 downward and move the outlet 2108 to the insertion level (see Fig.24C) below and / or moved to a sufficiently low position to allow the initiation of a siphoning action and the start of body fluid flow. At this level, the siphoning flow begins and the body fluid can be discharged into the external reservoir 2402. The flow rate can be controlled by adjusting the height of the outlet relative to the insertion site, and the flow rate can be increased by manually compressing the pumping chamber. Once the discharge stops, if necessary, the person can alternately compress and decompress the pumping chamber 2110 again to discharge additional body fluid from the body cavity 2124. In an example, the length of the tube 2122 (and more specifically, the length of the portion of the tube 2122 outside the body) can be set to control the vacuum level and / or maximum vacuum that the siphon generates and / or can generate. In addition, in some examples, a one-way valve, a pipe diameter and / or a pipe length can be selected to ensure a desired minimum flow rate, such as 25 milliliters per minute (ml / min) or greater, 50 ml / min or greater, 75 ml / min or greater, 100 ml / min, 125 ml / min or greater, 150 ml / min or greater, 175 ml / min or greater, and the like.

[0186] Once the desired discharge is complete, the person may move the adjustable entry lock 2120 to the locked position (see Fig.24D ), thereby isolating the tube 2122 and the body cavity 2124. The pumping chamber 2110 can then be compressed, thereby emptying the pumping chamber 2110 and placing it under vacuum as the elastic pumping chamber 2110 attempts to rebound (see Fig.24D Finally, the person can clean or decontaminate the outlet 2108 (clean with soap and water and / or decontaminate with alcohol, povidone iodine or chlorhexidine, etc.).

[0187] Closing the adjustable inlet lock 2120 completely isolates the pumping chamber 2110 from the tube 2122 and the body cavity 2124. This isolation can prevent additional body fluid from entering the pumping chamber 2110 from the tube 2122 and / or the body cavity 2124. In the absence of an inlet lock between the tube 2122 and the inlet of the valve assembly, over time (e.g., between discharge periods when the user is not actively discharging body fluid from the body cavity), body fluid from the body cavity will flow into the pumping chamber via the inlet and the inlet check valve. In this case, in the absence of an inlet lock between the tube 2122 and the inlet of the valve assembly, although the check valve prevents backflow (and thus body fluid from the pumping chamber is isolated from moving back toward the body cavity), body fluid from the body cavity can still enter the pumping chamber via the inlet check valve. On the other hand, advantageously, the adjustable inlet lock 2120 can isolate the pumping chamber 2110 from the body cavity 2124 such that body fluids from the body cavity cannot flow into the pumping chamber 2110 when the adjustable inlet lock 2120 is in the locked position.

[0188] This isolation provides redundant protection against backflow of bodily fluid from the pumping chamber 2110 into the tube 2122 and / or the body cavity 2124, as well as protection against the ingress of bacteria into the tube 2122 and / or the body cavity 2124. In particular, the one-way valve 2112 not only provides protection against (i) backflow of bodily fluid from the pumping chamber 2110 into the tube 2122 and / or the body cavity 2124 and (ii) ingress of bacteria into the tube 2122 and / or the body cavity 2124, but the isolation provided by the adjustable inlet lock 2120 also provides protection against (i) backflow of bodily fluid from the pumping chamber 2110 into the tube 2122 and / or the body cavity 2124 and (ii) ingress of bacteria into the tube 2122 and / or the body cavity 2124.

[0189] In addition, with the second one-way valve 2116 and the adjustable inlet lock 2120 closed, the compression of the elastic pumping chamber 2110 will evacuate the contents of the pumping chamber 2110 and place the pumping chamber 2110 under vacuum. The evacuation of body fluids and / or vacuum at this stage has multiple advantages. For example, as an example, advantageously, the lack of body fluids in the pumping chamber 2110 means that the accidental compression of the pumping chamber 2110 between uses (e.g., accidental compression caused by a person lying on the pumping chamber 2110 between uses) means that the pumping chamber 2110 will not be over-pressurized. In some cases, if the pumping chamber is over-pressurized and compressed with high force (e.g., unintentional compression, such as being lying on or sitting on it), there may be a risk of damaging one or more components of the valve assembly (e.g., damaging one or more of the one-way valves, the joint between the one-way valve and the pumping chamber body, and / or the body of the pumping chamber, etc.). Ensuring that the pumping chamber 2110 is not over-pressurized may help reduce or limit the potential risk of damage to one or more components of the valve assembly due to over-pressurization of the pumping chamber 2110 .

[0190] As another example, the lack of body fluid in the pumping chamber 2110 helps prevent clotting within the pumping chamber 2110. If biological materials are statically located in the pumping chamber 2110 and these biological materials may coagulate, there may be a risk that the materials may coagulate. The biological materials may include proteins that act as coagulation factors, and leaving such materials in the pumping chamber 2110 for a threshold period of time (e.g., 6 hours or more, 12 hours or more, 24 hours or more, and / or 48 hours or more) may result in larger strands of fibers forming and / or larger clots forming. The coagulation may act to block the valve assembly 2104 and render the valve assembly 2104 inoperative. In addition or alternatively, coagulation may increase the risk of damaging one or more components of the valve assembly (e.g., damaging one or more of the one-way valves and / or the joint between the one-way valve and the pumping chamber body, etc.), so preventing or limiting coagulation may advantageously prevent or reduce the risk of damaging one or more components of the valve assembly.

[0191] As another example, the lack of bodily fluid in the pumping chamber 2110 also means that there is less biological material within the bodily fluid management system 2100, so that if bacteria enter the pumping chamber 2110 during use of the bodily fluid management system 2100, there is less material within which the bacteria can grow. Bacteria can cause infection, so it may be desirable to prevent or limit bacterial growth within the bodily fluid management system. Biological material may include proteins and / or solutes that may act as a bacterial culture medium in which bacteria may grow. The absence of bodily fluid in the pumping chamber 2110 may prevent or limit bacterial culture in the pumping chamber.

[0192] Additionally, placing the valve assembly 2104 of the bodily fluid management system outside the human body can also help prevent or limit bacterial growth / activity. In this regard, given that the valve assembly 2104 is placed outside the human body, the temperature within the pumping chamber 2110 will also be lower than the temperature within the human body, which serves to limit or reduce the rate of bacterial growth / activity and also limit or reduce the rate of condensation formation.

[0193] As yet another example, the vacuum maintained within the pumping chamber 2110 also provides a bias pressure gradient to limit or prevent bacteria from entering the tube 2122 from the pumping chamber 2110 and subsequently entering the body cavity 2124. In this regard, while both the first one-way valve 2112 and the adjustable inlet lock 2120 provide an impediment to bodily fluid moving from the pumping chamber 2110 into the tube 2122, in some cases, the valve assembly may have a micropore or microchannel between the pumping chamber 2110 and the tube 2122, and a small amount of bodily fluid may move upstream from the pumping chamber 2110 into the tube 2122 via the micropore or microchannel. Thus, in the event that bacteria were to enter the valve assembly 2104, the bacteria may move upstream from the pumping chamber 2110 into the tube 2122 via the micropore or microchannel.

[0194] However, the biasing pressure gradient provided by the maintained vacuum within the pumping chamber may make it more difficult for bodily fluid to move upstream from the pumping chamber 2110 to the tube 2122 via the micropores or microchannels than if no vacuum was maintained in the pumping chamber. Because the pressure gradient may make it difficult for bodily fluid to move upstream, the bodily fluid will remain in the pumping chamber 2110 and will not be able to move upstream from the pumping chamber 2110 to the tube 2122 via the micropores or microchannels in the valve assembly.

[0195] As an illustrative example, the pumping chamber is at 10 cmH 2In the case where the pumping chamber is at atmospheric pressure and the tube 2122 is at atmospheric pressure, it may be more difficult for bodily fluid to move upstream from the pumping chamber 2110 to the tube 2122 via the micropores or microchannels in the valve assembly 2104 than in the case where the pumping chamber is at atmospheric pressure and the tube is at atmospheric pressure. Thus, the bias pressure gradient provided by the maintained vacuum provides an additional barrier to bacteria entering the tube 2122 from the pumping chamber 2110. In particular, not only do the one-way valve 2112 and the adjustable inlet lock 2120 provide a barrier to bacteria entering the tube 2122 from the pumping chamber 2110, but the bias pressure gradient provided by the vacuum maintained within the pumping chamber 2110 provides an additional barrier to bacteria entering the tube 2122 from the pumping chamber 2110.

[0196] In some examples, the valve assembly 2104 is non-removably attached to the tube 2122. Additionally, in some examples, the adjustable inlet lock 2120 of the valve assembly 2104 is non-removably attached to the valve assembly 2104.

[0197] As described above, each of the first one-way valve 2112 and the second one-way valve 2116 is configured to open and close based on compression and decompression of the pumping chamber 2110. In some examples, each of the first one-way valve 2112 and the second one-way valve 2116 is also configured to open and close based on pressure fluctuations between the human body cavity 2124 and the one-way valve, which pressure fluctuations occur based on the breathing action of the human breathing cycle. For example, in some examples, the first one-way valve 2112 and the second one-way valve 2116 are configured in the manner described above with respect to the one-way valves 110, 110' and 110'. It should be understood that any possibilities and permutations described with respect to the one-way valves 110, 110' and 110" are also possible with respect to the first one-way valve 2112 and the second one-way valve 2116.

[0198] In addition to or as an alternative to including an adjustable inlet lock such as adjustable inlet lock 2120, the bodily fluid management system can include an adjustable outlet lock. For example, FIG. 25A to FIG. 25C An exemplary bodily fluid management system 2500 is depicted, and Fig.25D A bodily fluid management system 2500 is depicted implanted in a human body 2502. The bodily fluid management system 2500 includes a valve assembly 2504 having an inlet 2506, an outlet 2508, a pumping chamber 2510 between the inlet and the outlet and configured to be compressed and decompressed to pump bodily fluid, a first one-way valve 2512 (see FIG. 2 ) positioned on a first side 2514 of the pumping chamber 2510 (e.g., an end of the pumping chamber proximal to the inlet 2506). FIG. 25B to FIG. 25C ), a second one-way valve 2516 (see FIG. 25A ), positioned on a second side 2518 of the pumping chamber 2510 (eg, an end of the pumping chamber 2510 proximal to the outlet 2508) FIG. 25B to FIG. 25C), an adjustable inlet lock 2520 configured to selectively prevent body fluids from moving through the inlet 2506, and an adjustable outlet lock 2530 configured to selectively prevent body fluids from moving through the outlet 2508.

[0199] The body fluid management system 2500 also includes a body fluid management tube 2522 for transporting body fluid from the body cavity 2524 to the valve assembly 2504. The tube 2522 is configured to extend from the inlet 2506 to the body cavity 2524 and allow body fluid to move from the cavity 2524 to the inlet 2506 of the valve assembly 2504. The tube 2522 is implanted in the human body 2502 so that the proximal end 2526 of the tube 2522 is positioned within the cavity 2524 and the distal end 2528 is positioned outside the human body 2502. In addition, the valve assembly 2504 is located outside the human body 2502.

[0200] In some examples, the tube 2522 can have a cuff along its length that can be placed within the tissue of the human body 2502 near the exit of the tube 2522 from the human body 2502. Such a cuff can be, for example, made of fibers made of a material that allows tissue to grow inward into the fibers of the cuff, forms a barrier to bacterial entry, and helps to secure the tube 2522 in place over time. For example, such a cuff can be made of a material such as polyethylene terephthalate. In addition, in some examples, the tube 2522 can have features along its length that are configured to allow the tube to be secured to the human body 2502 using suture material.

[0201] Cavity 2524 may be a cavity within the human body 2502 that may accumulate bodily fluids that are desired or required to be selectively drained from the body. FIG. 25A to FIG. 25D In the example of FIG. 25 , cavity 2524 is the pleural cavity of human body 2502. However, other body cavities are possible, such as the peritoneal cavity, the cerebrospinal cavity, the pericardial cavity, the breast cavity, or the cavity of a cystic lesion, etc.

[0202] Each of the first one-way valve 2512 and the second one-way valve 2516 is configured to open and close based on the compression and decompression of the pumping chamber 2510. The compression and decompression of the pumping chamber 2510 are similar to those described above. FIG. 22A to FIG. 22DThe described compression and decompression of the pumping chamber 2110 are therefore not described in detail. However, it should be understood that any possibilities and permutations described with respect to the compression and decompression of the pumping chamber 2110 can also be described with respect to the compression and decompression of the pumping chamber 2510. Similarly, the opening pressure and resealing pressure of the first one-way valve 2512 and the second one-way valve 2516 can be the same or similar to the opening pressure and resealing pressure of the inlet one-way valve 2112 and the outlet one-way valve 2116, and therefore are not described in detail. However, it should be understood that any possibilities and permutations described with respect to the opening pressure and resealing pressure of the inlet one-way valve 2112 and the outlet one-way valve 2116 are also possible with respect to the opening pressure and resealing pressure of each of the first one-way valve 2512 and the second one-way valve 2516.

[0203] In the example, the adjustable inlet lock 2520 is positioned upstream of the first one-way valve 2512 (in the direction of arrow 2550), and the adjustable outlet lock 2530 is positioned downstream of the second one-way valve 2516 (in the direction of arrow 2552). Fig.25B , the first one-way valve 2512 can be positioned within the pumping chamber 2510 at a position 2532, and the adjustable inlet lock 2520 is positioned upstream of the first one-way valve 2512 at a position 2534. In addition, the second one-way valve 2516 can be positioned within the pumping chamber 2510 at a position 2536, and the adjustable outlet lock 2530 is positioned downstream of the second one-way valve 2516 at a position 2538.

[0204] In some examples, valve assembly 2504 is non-removably attached to tube 2522. Additionally, in some examples, adjustable inlet lock 2520 of valve assembly 2504 is non-removably attached to valve assembly 2504, and adjustable outlet lock 2530 is non-removably attached to valve assembly 2504.

[0205] refer to FIG. 26A to FIG. 26E The operation of the body fluid management system 2500 is described. To initiate the draining process, a person may first select an external reservoir 2600 (see Fig.26C) in which the bodily fluid is discharged from cavity 2524. Generally, the person can discharge the bodily fluid into any suitable reservoir, such as a sink, toilet, and / or container provided by the person, etc. In addition, before initiating the discharge, the valve assembly area can be cleaned with soap and water and / or decontaminated with alcohol, povidone iodine or chlorhexidine, etc. In some examples, when the valve assembly is closed (and / or when also open), there is a gap so that if alcohol or soap and water is poured onto the locking portion and / or outlet portion of the bodily fluid management system (or if such portion is poured into such bodily fluid), the alcohol or soap and water can easily flow between the locking mechanism and the outlet conduit to provide more thorough decontamination. Next, to initiate the discharge process, the person can point upward at outlet 2508, switch the adjustable inlet lock 2520 to the unlocked position, and switch the adjustable outlet lock 2530 to the unlocked position (see Fig.26A ).

[0206] With outlet 2508 pointing upward, adjustable inlet lock 2520 in the unlocked position, and adjustable outlet lock 2530 in the unlocked position, a person can alternately compress and decompress pumping chamber 2510 until pumping chamber 2510 is filled or substantially filled with body fluid (see Fig.26B ,and Fig.26A When pumping chamber 2510 is full or substantially full of bodily fluid, a person can then point outlet 2508 downward and move outlet 2508 to the insertion level (see Fig.26C ) below and / or moved to a sufficiently low position to allow the siphon action to initiate and the body fluid to begin to flow. At this level, the siphon flow begins and the body fluid can be discharged into the reservoir 2600 (see Fig.26C ). The flow rate can be controlled by adjusting the height of the outlet relative to the insertion site, and the flow can be increased by manually compressing the pumping chamber. Once the discharge stops, if necessary, the person can again alternately compress and decompress the pumping chamber 2510 to discharge additional body fluid from the body cavity 2524. In an example, the length of the tube 2522 (and more specifically, the length of the portion of the tube 2522 outside the body) can be set to control the vacuum level and / or maximum vacuum that the siphon generates and / or can generate.

[0207] In addition, in some examples, the one-way valve, tubing diameter and / or tubing length can be selected to ensure a desired minimum flow rate, such as 25 milliliters per minute (ml / min) or greater, 50 ml / min or greater, 75 ml / min or greater, 100 ml / min, 125 ml / min or greater, 150 ml / min or greater, 175 ml / min or greater, and so on.

[0208] As a specific illustrative experimental example, five experimental runs were performed to measure the peak pressure and flow rate during siphoning with a given column height (30 cm) for a valve assembly having a first set of one-way valves and a tube having an outer diameter of 15 mm and a length of 52 mm. The peak pressure corresponds to the maximum vacuum created when the pumping chamber is maximally compressed and then released. In addition, the column height (30 cm in this experiment) is the difference between the liquid level in the chamber and the outlet. The first experimental run resulted in -98.8 cmH 2 Peak pressure of O (cmH 2 O) and a flow rate (ml / min) of 66 ml / min. In addition, the second experimental run resulted in a peak pressure of -106.5 and a flow rate of 67 ml / min. Further, the third experimental run resulted in a peak pressure of -102.7 cmH 2 O peak pressure and a flow rate of 65 ml / min. Furthermore, the fourth experimental run resulted in -114.1 cm H 2 O peak pressure and 68 ml / min flow rate. And further, the fifth experimental run resulted in -98.7 cmH 2 O and a flow rate of 67 ml / min. For this particular illustrative experimental example, the experimental results have a peak pressure of -104.2 cm H 2 The mean peak pressure of O was 6.60 mL / min (standard deviation + / - 6.4) and the mean flow rate (ml / min) was 66.6 mL / min (standard deviation + / - 1.1).

[0209] As a further specific illustrative experimental example, five experimental runs were performed to measure the peak pressure and flow rate during siphoning with a given column height (30 cm) for a valve assembly having a second set of one-way valves (different from the first set described above) and a tube having an outer diameter of 15 mm and a length of 55 mm. The first experimental run resulted in a peak pressure of -132.6 cm H 2 The peak pressure of 0.01 and the flow rate of 157.5 ml / min (ml / min) were 0.01 and 0.02 respectively. In addition, the second experimental run resulted in a peak pressure of -129.6 and a flow rate of 156.3 ml / min. Further, the third experimental run resulted in a peak pressure of -133.2 cmH 2 O peak pressure and a flow rate of 155.0 ml / min. Furthermore, the fourth experimental run resulted in -141.5 cmH 2 O peak pressure and a flow rate of 155.0 ml / min. And further, the fifth experimental run resulted in -140.8 cm H 2 O and a flow rate of 157.5 ml / min. For this additional specific illustrative experimental example, the experimental results have a peak pressure of -133.5 cmH 2The mean peak pressure of O was 1.000 % (standard deviation + / - 5.3) and the mean flow rate (ml / min) was 156.3 ml / min (standard deviation + / - 1.25).

[0210] Other example peak pressures and flow rates are possible.

[0211] Once the desired discharge is complete, the person can move the adjustable inlet lock 2520 to the locked position, thereby isolating the tube 2522 from the body cavity 2524 (see Fig.26D ). The pumping chamber 2510 can then be compressed, thereby emptying the pumping chamber 2510 and placing it under vacuum as the elastic pumping chamber 2510 attempts to rebound and the outlet check valve 2516 closes. Finally, a person can clean or decontaminate the outlet 2508 (clean with soap and water and / or decontaminate with alcohol, povidone iodine or chlorhexidine, etc.).

[0212] Once the outlet 2508 has been cleaned or decontaminated, a person may move the adjustable outlet lock 2530 to the locked position (see Fig.26E ). In this configuration, the pumping chamber 2510 is protected from backflow from the outside not only by the outlet check valve 2516, but also by the bidirectional blockage provided by the locked adjustable outlet lock 2530. Similarly, not only is the tube 2522 in fluid communication with the body cavity 2524 prevented from backflow by the first check valve 2512, but the tube 2522 is also prevented from backflow by the bidirectional blockage provided by the locked adjustable inlet lock 2520. In addition, the closed adjustable inlet lock 2520 and the closed adjustable outlet lock 2530 isolate the interior of the pumping chamber 2510 from the outside and the body cavity 2524, provide a bidirectional barrier between the outside and the body cavity 2524, and finally provide redundant backflow prevention.

[0213] exist FIG. 25A to FIG. 25D In the example of , the adjustable inlet lock 2520 is shown as a twist lock configured to pinch the tube 2522 and / or the inlet 2506. For example, FIG. 25A to FIG. 25B The adjustable inlet lock 2520 is shown in a closed position (eg, with the twist lock pinching a tube 2522 positioned at the inlet 2506), and Fig. 21C and FIG. 26A to FIG. 26C The adjustable inlet lock 2520 is shown after it has been rotated in direction 2602 to be in an open position (e.g., where the twist cap no longer pinches the tube 2522 at the inlet 2506). Rotation can move the twist lock from the closed position to the open position. Additionally, rotation in the opposite direction 2604 moves the adjustable inlet lock 2520 from the open position to the closed position. FIG. 25A to FIG. 25D The twist lock / adjustable entry lock 2520 is similar to the reference FIG. 8A to FIG. 8DThe twist cap is described as functioning in a manner (eg, a twist lock configured to activate a pinch arm to pinch the tube 2522 at the inlet 2506) and therefore will not be described in detail.

[0214] Despite FIG. 25A to FIG. 25D In the example of FIG. 2 , the adjustable entry lock 2520 takes the form of a twist lock, but various adjustable entry locks 2520 are possible. For example, the adjustable entry lock 2520 can take the form of a pinch piece, a pinch bar, and an offset device (e.g., similar to FIG. 6A to FIG. 6B , FIG. 7A to FIG. 7B , 9A to 9C and FIG. 10A to FIG. 10B The form of the exit lock shown in ) and so on.

[0215] Similarly, in FIG. 25A to FIG. 25D In the example of , the adjustable outlet lock 2530 is shown as a twist lock configured to pinch the outlet 2508 and / or a tube in fluid communication with the outlet 2508. For example, FIG. 25A to FIG. 25B The adjustable outlet lock 2530 is shown in a closed position (eg, with the twist lock pinching a tube in fluid communication with the outlet 2508), and Fig.25C Hehe 26A to Fig.26D The adjustable outlet lock 2530 is shown after it has been rotated in direction 2602 to be in an open position (e.g., where the twist lock no longer pinches a tube in fluid communication with the outlet 2508). Rotation can move the twist lock from a closed position to an open position. Additionally, rotation in the opposite direction 2604 moves the twist lock from an open position to a closed position. FIG. 25A to FIG. 25D The twist lock / adjustable exit lock 2530 is similar to the reference FIG. 8A to FIG. 8D The twist cap functions in the manner described (eg, a twist lock configured to activate a pinch arm to pinch the outlet 2508 and / or a tube in fluid communication with the outlet 2508), and thus will not be described in detail.

[0216] Despite FIG. 25A to FIG. 25D In the example of the adjustable exit lock 2530, the adjustable exit lock 2530 takes the form of a twist lock, but various adjustable exit locks 2530 are possible. For example, the adjustable exit lock 2530 can take the form of a pinch piece, a pinch bar, and an offset device (e.g., similar to FIG. 6A to FIG. 6B , FIG. 7A to FIG. 7B , 9A to 9C and FIG. 10A to FIG. 10B The form of the exit lock shown in ), etc.

[0217] In some examples, the adjustable entry lock 2520 and the adjustable exit lock 2530 are configured so that each can be grasped by a user and twisted simultaneously so that both adjustable locks can be opened in a single stage. For example, the adjustable entry lock 2520 and the adjustable exit lock 2530 can have the same right-hand thread or the same left-hand thread so that both can be twisted open simultaneously in a single stage, rather than requiring the user to sequentially open the locks in two different stages. Such a single-stage opening process may be useful, for example, for users who suffer from dexterity issues.

[0218] As described above, each of the first one-way valve 2512 and the second one-way valve 2516 is configured to open and close based on the compression and decompression of the pumping chamber 2510. In some examples, each of the first one-way valve 2512 and the second one-way valve 2516 is also configured to open and close based on pressure fluctuations between the human body cavity 2524 and the one-way valve, which pressure fluctuations occur based on the breathing action of the human breathing cycle. For example, in some examples, the first one-way valve 2512 and the second one-way valve 2516 are configured in the manner described above with respect to the one-way valves 110, 110' and 110". It should be understood that any possibilities and permutations described with respect to the one-way valves 110, 110', 110" are also possible with respect to the first one-way valve 2512 and the second one-way valve 2516.

[0219] In some examples, the pumping chamber 2110 of the fluid management system 2100, the pumping chamber 2510 of the fluid management system 2500, and / or the pumping chamber 402 of the fluid management system 100' are each configured to provide the ability to recoil at a given pressure. In this regard, the thickness of the body of the pumping chamber can affect the recoil pressure provided by the pumping chamber. For example, as an illustrative example, a pumping chamber formed of silicon and having a half-inch inner diameter and a 5 / 8-inch outer diameter can provide approximately -100 cmH 2 In another example, however, a pumping chamber formed of silicon and having thicker walls can provide a greater rebound pressure. For example, in an example, a pumping chamber formed of silicon and having a half-inch inner diameter and a 7 / 8-inch outer diameter will provide a greater rebound pressure than a pumping chamber formed of silicon and having a half-inch inner diameter and a 5 / 8-inch outer diameter. In addition, the shape of the pumping chamber can also affect the rebound pressure provided by the pumping chamber. For example, in an example, a pumping chamber having a first shape (e.g., elliptical) and a given wall thickness will rebound at a different pressure than a pumping chamber having a second, different shape (e.g., tubular) and the same given wall thickness. Other examples are also possible.

[0220] In an example, the pumping chamber of the disclosed body fluid management system is configured to have a given maximum rebound pressure. Various maximum rebound pressures are possible. For example, in one example, the maximum rebound pressure can range from about -300 cmH to about -100 cmH. 2 O to about -50cmcmH 2 O, and as a specific example, the maximum rebound pressure may be about -300 cmH 2 O, -275cmH 2 O, -250cmH 2 O, -225cmH 2 O, -200cmH 2 O, about -175cmH 2 O, about -150cmH 2 O, about -125cmH 2 O, about -100cmH 2 O, about -75cmH 2 O or about -50cmH 2 O, etc.

[0221] In an example, the maximum rebound pressure of the pumping chamber may be adjusted based on the shape and / or thickness of the pumping chamber. More specifically, the shape and / or thickness of the pumping chamber may be selected based on a desired maximum rebound pressure of the pumping chamber.

[0222] In an example, the valve assembly may include a compression limiter that is configured to limit the amount of compression that is possible. In this case, if the pumping chamber is fully compressed to the compression limiter, it can fully rebound and generate maximum suction. For example, the pumping chamber may include locally thickened sections of the pumping chamber wall that are positioned relative to each other so that when the pumping chamber is compressed, these thickened areas combine together to meet, preventing further compression, and limiting the amount of change in the volume of the pumping chamber that occurs with compression. In another example, the compression limiter includes one or more ridges and / or one or more protrusions that are attached to the pumping chamber wall that limits the compression. Other compression limiters are also possible.

[0223] Providing a given maximum rebound pressure may be beneficial for a variety of reasons. As an example, it may be desirable to have a given maximum rebound pressure in order to maintain comfort for a user using a fluid management system. In practice, a rebound pressure that is too high may be uncomfortable for the user, and so a given maximum rebound pressure may be selected in order to maintain and / or ensure comfortable operation for the user. As another example, having a given maximum rebound pressure may be desirable in order to provide the ability to provide a sufficiently large rebound pressure that effectively re-expands the user's lungs in the event that the user has a collapsed lung. Collapsed lung syndrome refers to a condition in which a lung does not fully expand relative to the chest wall during pleural drainage. Typically, for a lung in which fluid is present in the chest and the fluid is drained, a normal healthy lung will expand and fill the space. In addition, even a large portion of a damaged lung will expand and fill the space after drainage. However, some lungs may have a thickened surface and / or have collapsed and / or changed for a sufficiently long time so that when fluid is drained from the space, the lung will not expand back to fill the space after drainage. Therefore, the maximum rebound pressure may be selected so as to provide a sufficiently large rebound pressure that effectively helps to re-expand the user's lungs in the event that the user has a collapsed lung (e.g., the selected maximum rebound pressure is between -1000 cmH 2 O and -200cmH 2 As yet another example, having a given maximum rebound pressure may help overcome catheter blockage. A given maximum rebound pressure may also be beneficial for other reasons.

[0224] Furthermore, in some examples, the pumping chamber 2110 of the fluid management system 2100, the pumping chamber 2510 of the fluid management system 2500, and / or the pumping chamber 402 of the fluid management system 100' are each configured to provide the ability to rebound at a plurality of different pressures. For example, the body of the pumping chamber may be shaped and / or sized to rebound at a plurality of different pressures. In this regard, as an illustrative example, Fig. 27 A pumping chamber 2700 is shown that is configured to provide the ability to rebound at two different pressures. In particular, the pumping chamber 2700 includes a first portion 2702 and a second portion 2704, the first portion 2702 being configured to be compressed and to be at a first pressure (shown as -200 cmH in this example). 2 O) rebound, the second portion 2704 is configured to be compressed and to be at a second pressure (shown as -100 cmH in this example) 2 O) Resilience. In order to provide the ability to rebound under different pressures, the thickness of the first portion 2702 can be different from the thickness of the second portion 2704.

[0225] As another illustrative example, Fig.28AA pumping chamber 2800 is shown that is configured to provide the ability to rebound at two different pressures. In particular, the pumping chamber 2800 includes a first portion 2802 and a second portion 2804, the first portion 2802 being configured to be compressed and to be at a first pressure (shown as -20 cmH in this example). 2 O) rebound, the second portion 2804 is configured to be compressed and to be at a second pressure (shown as -30 cmH in this example). 2 O) Rebound. In this example, first portion 2802 is a first set of walls of pumping chamber 2800 (e.g., walls positioned at 0 and 180 degrees relative to the axis of the pumping chamber), and second portion 2804 is a second set of walls of pumping chamber 2800 (e.g., walls positioned at 90 and 270 degrees relative to the axis of the pumping chamber). For example, a user can use their fingers to compress pumping chamber 2800 at a set of walls that corresponds to the user's desired rebound pressure. In order to provide the ability to rebound at different pressures, the thickness of first portion 2802 can be different from the thickness of second portion 2804. For example, referring to Fig.28B (It is along the Fig.28A AA), the body of the pumping chamber 2800 is configured such that the thickness of the second portion 2804 is greater than the thickness of the first portion 2802. Other examples are also possible.

[0226] In an example, a plurality of different rebound pressures of the pumping chamber may be adjusted based on the shape and / or thickness of the pumping chamber. More specifically, the shape and / or thickness of the pumping chamber may be selected based on a desired plurality of different rebound pressures for the pumping chamber.

[0227] Additionally or alternatively, within an example, multiple different rebound pressures for the pumping chamber can be provided by multiple compression limiters. For example, the valve assembly can include (i) a first compression limiter for a first portion of the pumping chamber, such that the valve assembly is configured to generate a first suction pressure after compressing the first portion, and (ii) a second compression limiter for a second portion of the pumping chamber, such that the valve assembly is configured to generate a second suction pressure after compressing the second portion. In this case, (i) if the pumping chamber is compressed to the first compression limiter at the first portion of the pumping chamber, it can rebound and generate a first suction force, and (ii) if the pumping chamber is compressed to the second compression limiter at the second portion, it can rebound and generate a second, different suction force.

[0228] As an illustrative example, Fig.45A A pumping chamber 4500 is shown that is configured to provide the ability to rebound at two different pressures. In particular, the pumping chamber 4500 includes a first portion 4502 and a second portion 4504, the first portion 4502 being configured to compress and rebound at a first pressure (shown as -50 cmH in this example).2 O), the second portion 4504 is configured to compress and rebound at a second pressure (shown as -100 cmH in this example). 2 O). In this example, reference Fig.45B , pumping chamber 4500 includes a first compression limiter 4506 for first portion 4502 and a second compression limiter 4508 for second portion 4504. First compression limiter 4506 includes a thickened wall section of a first thickness, and second compression limiter 4508 includes a thickened wall section of a second thickness. Fig.45C , when the first portion 4502 is compressed, the thickened wall sections of the compression limiter 4506 come together to meet and prevent further compression. When the portion 4502 is released, the pumping chamber wall sections 4510a-d provide a rebound force. On the other hand, if the second portion 4504 is compressed instead of the first portion 4502, the compression limiter 4508 will allow more deformation than the compression limiter 4506. Therefore, if the second portion 4506 is compressed, the rebound section will deform more and rebound more, thereby providing a higher rebound pressure.

[0229] Providing a plurality of different rebound pressures may be beneficial for a variety of reasons. As one example, it may be desirable to have a plurality of different rebound pressures to account for user preferences (e.g., user preferences related to a preferred pump speed and / or different comfort levels or pain tolerance levels for a user of the bodily fluid management system). For example, providing a plurality of different rebound pressures from which a user may select a given rebound pressure during operation of the bodily fluid management system may allow the user to select a rebound pressure based on the user's desired pump speed and / or the user's comfort level or pain tolerance level.

[0230] As another example, multiple rebound pressures may be useful for situations where a user may have a collapsed lung. For example, in an example, the pumping chamber may provide three vacuum levels, which in this example may be a low vacuum (e.g., between -20 and -50 cmH). 2 O range), moderate vacuum (e.g., -75 to -200 cmH 2 O range) and high vacuum (e.g., at -200 to -250 cmH 20 rebound pressure). As described above, a higher vacuum pressure may cause more discomfort to the user than a lower vacuum pressure. Therefore, the user may initially select a low vacuum to obtain the user's comfort level or pain tolerance level. However, if the low vacuum is not sufficient to cause or help the collapsed lung to re-expand, the user may pump the pumping chamber to generate a medium vacuum in order to try to re-expand the collapsed lung. In addition, if the medium vacuum is not sufficient to cause or help the collapsed lung to re-expand, the user may pump the pumping chamber to generate a high vacuum in order to try to re-expand the collapsed lung. Multiple rebound pressures may also be beneficial for other reasons.

[0231] In some examples, pumping chamber 2110 of fluid management system 2100, pumping chamber 2510 of fluid management system 2500, and / or pumping chamber 402 of fluid management system 100' are each configured to provide the ability to cut or break fiber strands during compression of the pumping chamber. In this regard, FIG. 29A to FIG. 29B A pumping chamber 2900 is shown including a plurality of first protrusions 2902 and a plurality of second protrusions 2904 . Fig.29B A partial cross-sectional view of the pumping chamber 2900 taken along line BB is shown. The first protrusion 2902 is disposed on a first portion 2906 (e.g., a first inner wall) of the body 2910 of the pumping chamber 2900, the first portion 2906 being opposite to a second portion 2908 (e.g., a second inner wall) of the body 2910 on which the second protrusion 2904 is disposed. The plurality of first protrusions 2902 are configured to interweave with the plurality of second protrusions during compression of the pumping chamber. By interweaving with each other during compression, the plurality of protrusions can cut or break the fiber strands during compression of the pumping chamber 2900, potentially allowing them to more easily pass through the body fluid management system (and more specifically, through the pumping chamber 2900 and out of the outlet 2912).

[0232] In some examples, fluid management system 2100, fluid management system 2500, and / or fluid management system 100' are each configured to provide access to a pumping chamber, an inlet of a valve assembly, and / or tubing of a fluid management system. Additionally, in some examples, fluid management system 100 can be configured to provide access to an inlet of a valve assembly and / or tubing of a fluid management system.

[0233] Access to the pumping chamber, the inlet of the valve assembly, and / or the tube of the fluid management system may be beneficial for various reasons. For example, with respect to the pumping chamber, it may be desirable to access the pumping chamber to access the pumping chamber and / or the one-way valve within the pumping chamber. In one example, access to the pumping chamber may be used to flush coagulation. As another example, access to the pumping chamber may be used to obtain a material sample (e.g., if the material within the pumping chamber is coagulated, then the material sample is obtained). In addition, with respect to the inlet of the valve assembly and / or the tube of the fluid management system, it may be desirable to access the inlet of the valve assembly and / or the tube of the fluid management system to deliver a treatment through the tube. For example, access to the inlet and / or the tube may be used to deliver a drug (e.g., a drug, an antibiotic, a chemotherapeutic agent, etc.) to a body cavity (e.g., a pleural cavity) that is in fluid communication with the tube. As another example, access to the inlet and / or the tube may be useful in the case of coagulation in one or more one-way valves (e.g., injecting body fluids to flush coagulation). As another example, access to the tube may be used to obtain a material sample (e.g., if the material within the inlet and / or the tube is coagulated, then the material sample is obtained).

[0234] To facilitate access to the pumping chamber, the inlet of the valve assembly, and / or the tubes of the body fluid management system, the body fluid management system 2100, the body fluid management system 2500, and / or the body fluid management system 100' can each be configured to provide access to the pumping chamber, the inlet of the valve assembly, and / or the tubes of the body fluid management system. For example, the valve assembly 2104, the valve assembly 2504, and / or the valve assembly 104' can include one or more of a pumping chamber access port and an inlet access port. In addition, the body fluid management system 100 can be configured to provide access to the inlet of the valve assembly and / or the tubes of the body fluid management system. For example, the valve assembly 104 can include an inlet access port.

[0235] In this regard, as illustrative examples of pumping chamber access ports and inlet access ports, Fig.30 A valve assembly 3000 is shown, which includes a pumping chamber access port 3002 and an inlet access port 3006 for a pumping chamber 3004. In some examples, the pumping chamber access port 3002 can be configured to provide access to a needle. In other examples, the pumping chamber access port 3002 can take the form of a needless access hub or port. Various needle access hubs are possible. As one possibility, the needle access hub can be a needle access port valve, which includes a gasket or a plug that can be pushed out to provide access to the pumping chamber. Other needle access hubs are also possible.

[0236] Similarly, in some examples, the inlet access port 3006 can be configured to provide access to the needle. In other examples, the inlet access port 3006 can take the form of a needle access hub or port. Various needle access hubs are possible. As one possibility, the needle access hub can be a needle access port valve that includes a gasket or plug that can be pushed out to provide access to the tube. Other needle access hubs are also possible.

[0237] In an example, the pumping chamber access port 3002 includes a thickened area in the wall of the pumping chamber. The thickened area can be configured to be penetrable by a needle to allow access by the needle and to reseal when the needle is removed from the thickened material. In such an example, the pumping chamber access port 3002 can also include a puncture-resistant material in the wall in an area opposite the pumping chamber access port. For example, referring to Fig.31A , the pumping chamber access port 3002 includes a thickened area 3102 in the wall 3104 of the pumping chamber 3004, and the pumping chamber 3004 also includes a puncture-resistant material 3106 in the wall 3110 located in an area 3108 opposite the pumping chamber access port 3002. Various puncture-resistant materials are possible. For example, in some examples, the puncture-resistant material can be a hard plastic such as nylon, Teflon, polyethylene terephthalate (PET) and / or polyamide, etc. In some examples, the puncture-resistant material can be a metal such as nitinol or stainless steel, etc. Other puncture-resistant materials are also possible.

[0238] In one example, the area in the wall opposite the pumping chamber access port is below the pumping chamber access port 3002. The puncture-resistant material can prevent or limit potential damage to the body of the pumping chamber 3004 by a needle or other device that can be inserted into the pumping chamber access port 3002. In addition, in one example, the pumping chamber access port 3002 is positioned away from the inlet check valve threshold distance (e.g., 2 mm or more) within the pumping chamber 3004, and away from the outlet check valve threshold distance (e.g., 2 mm or more) within the pumping chamber 3004. In some examples, the threshold distance away from the inlet check valve within the pumping chamber 3004 is 2 mm or more, 5 mm or more, or 7 mm or more, etc. In some examples, the threshold distance away from the outlet check valve within the pumping chamber 3004 is 2 mm or more, 5 mm or more, or 7 mm or more, etc. Positioning pumping chamber access port 3002 in this manner may help prevent or limit potential damage to the one-way valve by a needle or other device that may be inserted into pumping chamber access port 3002 .

[0239] Turning next to the inlet access port 3006, in an example, the inlet access port includes a thickened area in the wall of the valve assembly. The thickened area can be configured to be pierced by a needle so as to allow access by the needle and to reseal when the needle is removed from the thickened material. In addition, in such an example, the valve assembly can also include a puncture-resistant material in the wall in an area opposite the inlet access port. For example, referring to Fig.31B , the inlet access port 3006 includes a thickened area 3112 in a wall 3114 of the valve assembly 3000 , and the valve assembly 3000 also includes a puncture-resistant material 3116 in an area 3118 in the wall 3120 located opposite the inlet access port 3006 .

[0240] In one example, an area 3118 of the wall 3120 opposite the inlet access port 3006 is below the inlet access port 3006. The puncture-resistant material can prevent or limit potential damage to the body of the valve assembly by a needle or other device that can be inserted into the inlet access port. In addition, in an example, the inlet access port is positioned away from the inlet check valve and / or the inlet lock by a threshold distance (e.g., 2 mm or greater). In some examples, the threshold distance away from the inlet check valve and / or the inlet lock is 2 mm or greater, 5 mm or greater, or 7 mm or greater, etc. Positioning the inlet access port away from the inlet check valve and / or the inlet lock by a threshold distance can help prevent or limit potential damage to the check valve and / or the inlet lock by a needle or other device that can be inserted into the inlet access port.

[0241] In an example, the entry access port can be configured to be inaccessible and / or hidden from view when the entry lock is in the locked position. FIG. 32A to FIG. 32B , the valve assembly 3200 includes an inlet access port 3202 (see Fig.32B ), the entry access port 3202(i) is in a locked position (see Fig.32A ) is inaccessible and hidden from view, and (ii) when the adjustable entry lock 3204 is in the unlocked position (see Fig.32B In addition to providing aesthetic advantages, having an entry access port that is configured to be inaccessible and / or hidden from view when the entry lock is in the locked position advantageously provides an additional layer of protection because the entry access port is only accessible when the adjustable entry lock is in the unlocked position.

[0242] As described above, valve assembly 2104, valve assembly 2504, and / or valve assembly 104' may include one or more of a pumping chamber access port and an inlet access port. Thus, in some examples, valve assembly 2104, valve assembly 2504, and / or valve assembly 104' may include a pumping chamber access port instead of an inlet access port. In other examples, valve assembly 2104, valve assembly 2504, and / or valve assembly 104' may include an inlet access port instead of a pumping chamber access port. In this regard, as an illustrative example of a valve assembly having an inlet access port instead of a pumping chamber access port, Fig.40 A valve assembly 4000 is shown including an inlet access port 4002 rather than a pumping chamber access port.

[0243] In some examples, fluid management system 2100, fluid management system 2500, fluid management system 100', and fluid management system 100 can each further include a tube lock configured to lock the tube at a point external to the human body and upstream of the valve assembly. As described above, the fluid management system can include a pumping chamber access port and / or an inlet access port that allows access for, for example, flushing one or more components of the fluid management system. Such a tube lock can be configured to lock or pinch the tube, which can be helpful during flushing of the pumping chamber and / or the one-way valve. For example, referring to Fig.30 , the valve assembly 3000 may also include an adjustable tube lock 3022. The adjustable tube lock 3022 may be activated in a variety of ways to pinch the tube 3024, thereby clamping the tube.

[0244] A variety of adjustable tube locks are possible. In this regard, Fig.30 The adjustable tube lock 3022 is similar to the reference FIG. 7A to FIG. 7B The adjustable tube lock 3022 functions in the manner of a pinch piece as described above and is therefore not described in detail. However, the adjustable tube lock 3022 can take a variety of other forms. For example, the adjustable tube lock 3022 can take the form of a pinch piece, a pinch bar, and an offset device (e.g., similar to FIG. 6A to FIG. 6B , FIG. 7A to FIG. 7B , 9A to 9C and FIG. 10A to FIG. 10B ), etc. In addition, in some examples, the adjustable tube lock 3022 is non-removably attached to the tube 3024.

[0245] Additionally, in some examples, the adjustable tube lock 3022 is removable. In this regard, as an illustrative example of a removable adjustable tube lock, Fig.41 An adjustable tube lock 4100 is shown in the form of a clamp that can be placed on and removed from the tube as needed. For valve assemblies having an outlet lock instead of an inlet lock (e.g., Fig.40), an adjustable tube lock 4100 can be placed on the tube between the pumping chamber and the human body. When the adjustable tube lock 4100 is not placed on the tube, the access port can be communicated with a body cavity (e.g., a pleural space). On the other hand, when the adjustable tube lock 4100 is located on the tube and clamps the tube at a point between the pumping chamber and the human body, the body cavity is isolated from the access port and the pumping chamber. In addition, the access port can be in fluid communication with the inlet valve. If there is a blockage in the pumping chamber or the one-way valve, pressure can be applied (e.g., with a syringe) to clear the debris or blockage. The access port can be a luer lock with a removable cup or a self-sealing needleless access port.

[0246] As described above, the adjustable tube lock 3022 can ensure that bodily fluid is not forced back into the body when the pumping chamber 3004 is flushed via the inlet access port 3006. Instead, the adjustable tube lock 3022 will prevent bodily fluid from flowing upstream in the tube 3024 beyond the adjustable tube lock 3022, and instead, bodily fluid used to flush the valve assembly 3000 will flow through the valve and out the outlet of the bodily fluid management system.

[0247] In some examples, the pumping chamber 2110 of the bodily fluid management system 2100, the pumping chamber 2510 of the bodily fluid management system 2500, and / or the pumping chamber 402 of the bodily fluid management system 100' are each configured such that the distal end of the valve assembly is configured to fit into a variety of different bottles, such as bottles having openings of different sizes. In an example, the distal end of the valve assembly is tapered such that the distal end of the valve assembly can fit into multiple bottle openings of different sizes. Additionally, in one example, the distal end is tapered such that the end of the valve assembly is away from the wall of the bottle. In this regard, the taper can be symmetrical about the axis of the valve assembly.

[0248] As an illustrative example, refer to FIG. 33A to FIG. 33B , the valve assembly 3300 is configured so that the distal end 3302 can fit into the bottle 3304. The distal end 3302 can be tapered so that the tip of the valve assembly 3300 leaves the wall of the bottle 3304 when inserted into the opening of the bottle. The taper is symmetrical about the axis 3306 of the valve assembly.

[0249] In one example, bottle 3304 can have an externally threaded opening that is configured to be attached to a screw cap using internal threads. Such externally threaded openings configured to be attached to screw caps are common in various industries including, for example, the medical and food industries. As an example, soda bottles are typically provided with such externally threaded openings.

[0250] Additionally, in examples, it may be beneficial to have a vent that allows air to flow between the bottle and the valve assembly when the distal end of the valve assembly is inserted into the bottle. In this regard, the pumping chamber may be configured to provide a vent when the valve assembly is positioned to discharge into the bottle. The vent may take a variety of forms. As one possibility, the body of the pumping chamber may include a recess so that when the pumping chamber is positioned against the bottle opening, there is an air gap that allows air to flow between the interior of the bottle and the external environment. For example, referring to FIG. 34A to FIG. 34B , the pumping chamber 3400 includes a recess 3402 in the body 3404. Fig.34B A cross-sectional view of the body 3404 of the pumping chamber 3400 is shown taken along line CC. When the pumping chamber 3400 is positioned against the bottle opening, the recess 3402 provides an air gap that will allow flow between the interior of the bottle and the pumping chamber 3400 to the outside environment. Other example vents are possible.

[0251] In another example, in addition to or as an alternative to the distal end being configured to fit a vial, the distal end can be configured to be inserted into another tube. Fig.17As described, valve assembly 104' can be configured to be connected to indwelling catheter 1702. Similarly, valve assembly 2104 and valve assembly 2504 can also be configured to be connected to another tube, such as an outer tube. For example, in one example, the distal end of body fluid management system 2100, the distal end of body fluid management system 2500, the distal end of body fluid management system 100, and / or the distal end of body fluid management system 100 are each configured to be attached to a tube. In this regard, as an illustrative example, FIG. 35 shows a valve assembly 3500, which includes (i) an adjustable outlet lock 3502 of valve assembly 3500 and (ii) an attachment system 3504 on the distal end 3506 of valve assembly 3500. Attachment system 3504 is configured to be attached to the proximal end 3508 of tube 3510. Any suitable attachment system for connecting to the proximal end 3508 of tube 3510 is possible. In an example, the attachment system 3504 can be configured to provide an interference fit with the proximal end 3508 of the tube 3510. However, other attachment systems are also possible. After the valve assembly 3500 is connected to the tube 3510, the user can control the adjustable outlet lock 3502 (e.g., open and close the adjustable outlet lock 112) to discharge the body fluid from the body cavity and discharge the distal end (not shown) of the tube 3510 as needed. In an example, by being able to connect to an external tube such as tube 3510, the user (e.g., a patient or an individual assisting a patient) can use the tube to discharge into a reservoir that is not directly near the valve assembly 3500. In other words, if necessary, the ability to connect to an external tube can expand the scope of the body fluid management system. In an example, this ability to connect to an external tube can allow the body fluid management system to perform as a continuous drain thoracostomy tube when there is a need for continuous discharge (e.g., such as when a patient may be admitted to a hospital and / or intensive care unit (ICU)).

[0252] Other attachment systems for attaching to the tube are also possible. As another illustrative example, FIG. 42A to FIG. 42B A valve assembly 4200 including an adjustable outlet lock 4202 of the valve assembly 4200 is shown. Fig.42A The adjustable exit lock 4202 is shown in a closed position, and Fig.42B The adjustable exit lock 4202 is shown in an open position. The adjustable exit lock 4202 has a tapered portion 4204 that can be inserted into a chest tube drainage or aspiration tubing.

[0253] As yet another illustrative example, FIG. 43A to FIG. 43B A valve assembly 4300 is shown including an adjustable outlet lock 4302 of the valve assembly 4300 . Fig.43A The adjustable exit lock 4302 is shown in a closed position, and Fig.43BThe adjustable exit lock 4302 is shown in an open position. The adjustable exit lock 4302 has a tapered portion 4304 that can be inserted into a chest tube drainage or suction tubing. FIG. 42A to FIG. 42B Compared to adjustable exit lock 4202, adjustable exit lock 4302 has a flat area that can provide additional space for clamping the adjustable exit lock in order to rotate and unlock the exit lock.

[0254] Furthermore, in some examples, the valve assembly can be configured to attach to a plurality of different adapters and / or caps. For example, as an illustrative example, Fig.44 A valve assembly 4400 is shown that is configured to attach to a plurality of different adapters 4402a and 4402b. Adapter 4402a is an adapter that includes a wide base on which a cylinder with tapering external threads is mounted (and is commonly referred to as a "Christmas tree adapter"), and adapter 4402b is a tapered adapter. In turn, different adapters can provide different functions, such as connecting to different types of pipes. In addition, valve assembly 4400 can also be configured to attach to one or more caps, such as cap 4402c.

[0255] As described above, in one example, the one-way valve 110 may include a plurality of lips defining a slit that may be moved from a closed position to an open position. FIG. 2A to FIG. 2B The one-way valve 110 may include a first lip 202 and a second lip 204 defining a slit 206. The lips 202 and 204 may be configured such that when the lips are in the closed position, the interaction surface area between the lips is relatively small. For example, in one example, the interaction surface area is less than 60 mm. 2 , and preferably at 0.6 mm 2 Up to 6mm 2 within the range.

[0256] Similarly, in some examples, the one-way valves 2112 and 2116 of the bodily fluid management system 2100 and the one-way valves 2512 and 2516 of the bodily fluid management system 2500 each include a plurality of lips defining a slit that can be moved from a closed position to an open position. Fig.36A , the one-way valve 3600 may include a first lip 3602 and a second lip 3604 defining a slit 3606. The lips 3602 and 3604 may be configured such that when the lips are in a closed position, the interaction surface area between the lips is relatively small. The interaction surface area may be the length×width of the lips, such as Fig.36A Various surface areas of interaction are possible. For example, in the example, the interaction surface area can be less than 60 mm 2 , and as a specific example, less than 55 mm2 Less than 50mm 2 , less than 45mm 2 Less than 40mm 2 , less than 35mm 2 Less than 30mm 2 Less than 25mm 2 Less than 20mm 2 Less than 15mm 2 Less than 10mm 2 , less than 9mm 2 Less than 8mm 2 Less than 7mm 2 , less than 6mm 2 Less than 5mm 2 , less than 4mm 2 Less than 3mm 2 Less than 3mm 2 Less than 2mm 2 or less than 1mm 2 , etc. This interaction surface area can help ensure that the check valve works well both when wet and dry.

[0257] Furthermore, in some examples, the interaction surface area can be greater than 0.6 mm 2 In some examples, the interaction surface area can be 0.6 mm 2 Up to 60mm 2 In the range between 0.6mm 2 Up to 55mm 2 In the range between 0.6mm 2 Up to 50mm 2 In the range between 0.6mm 2 Up to 45mm 2 In the range between 0.6mm 2 Up to 40mm 2 In the range between 0.6mm 2 Up to 35mm 2 In the range between 0.6mm 2 Up to 30mm 2 In the range between 0.6mm 2 Up to 25mm 2 In the range between 0.6mm 2 Up to 20mm 2 In the range between 0.6mm 2 Up to 15mm 2 In the range between 0.6mm 2 Up to 10mm 2 In the range between 0.6mm 2Up to 9mm 2 In the range between 0.6mm 2 Up to 8mm 2 In the range between 0.6mm 2 Up to 7mm 2 In the range between 0.6mm 2 Up to 6mm 2 In the range between 0.6mm 2 Up to 5mm 2 In the range between 0.6mm 2 Up to 4mm 2 In the range between 0.6mm 2 Up to 3mm 2 In the range between 0.6mm 2 Up to 2mm 2 In the range between, or within 0.6mm 2 Up to 1mm 2 This interaction surface area can help ensure that the check valve works well both when wet and dry.

[0258] FIG. 36B to FIG. 36D The one-way valve 3600 is shown in different states. In particular, Fig.36B The one-way valve 3600 is shown in a dry or substantially dry state. Fig.36C The one-way valve 3600 is shown in a wet or partially wet state, and Fig.36D The one-way valve 3600 is shown in a fully wetted state. This interaction surface area can help ensure that the one-way valve FIG. 36B to FIG. 36D These various conditions shown work well.

[0259] In some examples, to prevent blockage or clogging of the disclosed fluid management systems 2100 and 2500, one or more components of the fluid management system can be coated with an anticoagulant or fibrinolytic factor. For example, components or surfaces (e.g., inner and / or outer surfaces) of the valve assembly 2104, 2504 and / or the implant tube 2122, 2522 can be at least partially coated with an anticoagulant or fibrinolytic factor. For example, referring to FIG. 21A to FIG. 21D , the inner portion and / or outer portion of the body of the pumping chamber 2110, the one-way valves 2112, 2116 and / or the inner portion of the tube 2122 may be coated with an anticoagulant factor or a fibrinolytic factor. FIG. 25A to FIG. 25D , the interior and / or exterior of the pumping chamber 2510, the one-way valves 2512, 2516, and / or the interior of the tube 2522 can be coated with an anticoagulant or fibrinolytic factor. Other components can also be coated with an anticoagulant or fibrinolytic factor.

[0260] As mentioned above, the existence of anticoagulant factors can reduce the amount of blood coagulation that will occur if they do not exist. Further, the example of anticoagulant factors comprises heparin, low molecular weight heparin, fondaparinux, idaparinux, itraparin, dabigatran etexilate, rivaroxaban, apisartan, betrixaban, edoxaban, darixaban, ritoxaban, elixaban, hirudin, lepirudin, bivalirudin, argatroban, dabigatran etexilate, simegatran, heme, vitamin E, coumarin, warfarin, acenocoumarol, phenprocoumon, atomycin, phenindione, bromadiolone and bifenthrin. The example of fibrinolytic factor comprises plasmin, tissue plasminogen activator, urokinase, streptokinase, plasminogen activator inhibitor-1 inhibitor and plasminogen activator inhibitor-2 inhibitor. Other examples of anticoagulant factors or fibrinolytic agents can be used.

[0261] Also provided are exemplary methods for facilitating the drainage of body fluids from a body cavity and for draining body fluids from a body cavity. Such methods may be, for example, described in reference FIG. 21A to FIG. 3 6 and / or the bodily fluid management system 2100 and / or 2500 described herein and / or performed using the bodily fluid management system 2100 or 2500.

[0262] Fig.37 A flow chart of an example method 3700 of bodily fluid management is shown. It should be understood that for this and other processes and methods disclosed herein, the flow chart illustrates the functionality and operation of one possible implementation of the present embodiment. Alternative implementations are included within the scope of the example embodiments of the present disclosure, where functions may be performed out of the order shown or discussed, including substantially simultaneously or in reverse order, depending on the functions involved, as will be understood by those skilled in the art.

[0263] At box 3702, method 3700 involves providing a body fluid management system for selectively discharging body fluid from a body cavity. The body fluid management system includes a valve assembly and a tube for transporting body fluid from a body cavity of a person to the valve assembly, wherein the valve assembly is positioned outside the human body and includes: (i) an inlet; (ii) an outlet; (iii) a pumping chamber between the inlet and the outlet and configured to be compressed and decompressed to pump body fluid; (iv) a first one-way valve positioned on a first side of the pumping chamber; (v) a second one-way valve positioned on a second side of the pumping chamber; and (vi) an adjustable inlet lock configured to selectively prevent body fluid from moving through the inlet, and wherein the tube is configured to extend from the inlet of the valve assembly to the body cavity of the person. In some examples, the body fluid management system also includes an adjustable outlet lock configured to selectively prevent body fluid from moving through the outlet, wherein the adjustable outlet lock is positioned downstream of the second one-way valve.

[0264] At block 3704, method 3700 involves implanting a portion of a bodily fluid management system in a human body such that a proximal end of the tube is in fluid communication with a cavity and the valve assembly is positioned outside the human body. At block 3706, after implanting the bodily fluid management system in a human body, the human body can use the bodily fluid management system to selectively drain bodily fluid from a body cavity, as described above.

[0265] Fig.38 A flow chart of an exemplary method 3800 for discharging bodily fluid from a body cavity of a person to a reservoir outside the person is shown. Specifically, method 3800 is a method of operating a bodily fluid management system, the bodily fluid management system including a valve assembly and a tube for conveying bodily fluid from a body cavity of a person to the valve assembly, wherein the valve assembly is positioned outside the person and includes: (i) an inlet; (ii) an outlet; (iii) a pumping chamber between the inlet and the outlet and configured to be compressed and decompressed to pump bodily fluid; (iv) a first one-way valve positioned on a first side of the pumping chamber; (v) a second one-way valve positioned on a second side of the pumping chamber; and (vi) an adjustable inlet lock configured to selectively prevent bodily fluid from moving through the inlet, and wherein the tube is configured to extend from the inlet of the valve assembly to the body cavity of the person. In some examples, the bodily fluid management system also includes an adjustable outlet lock configured to selectively prevent bodily fluid from moving through the outlet, wherein the adjustable outlet lock is positioned downstream of the second one-way valve.

[0266] At block 3802, method 3800 involves the adjustable inlet lock preventing body fluid from moving through the inlet and the outlet when the adjustable inlet lock is in the locked position. At block 3804, method 3800 involves each of the one-way valves opening and closing based on compression and decompression of the pumping chamber when the adjustable inlet lock is in the unlocked position to provide a pumping action to move body fluid from the body cavity through the tube, into the inlet, and out of the outlet to an external reservoir.

[0267] Fig.39A flow chart of an exemplary method 3900 for discharging bodily fluid from a body cavity of a person to a reservoir outside the person is shown. Specifically, method 3900 is a method of operating a bodily fluid management system, the bodily fluid management system including a valve assembly and a tube for conveying bodily fluid from a body cavity of a person to the valve assembly, wherein the valve assembly is positioned outside the person and includes: (i) an inlet; (ii) an outlet; (iii) a pumping chamber between the inlet and the outlet and configured to be compressed and decompressed to pump bodily fluid; (iv) a first one-way valve positioned on a first side of the pumping chamber; (v) a second one-way valve positioned on a second side of the pumping chamber; and (vi) an adjustable inlet lock configured to selectively prevent bodily fluid from moving through the inlet, and wherein the tube is configured to extend from the inlet of the valve assembly to the body cavity of the person. In some examples, the bodily fluid management system also includes an adjustable outlet lock configured to selectively prevent bodily fluid from moving through the outlet, wherein the adjustable outlet lock is positioned downstream of the second one-way valve.

[0268] At block 3902, method 3900 involves attaching an external portion of a bodily fluid management system to a human body when the adjustable access lock is in a locked position. The external portion of the bodily fluid management system can be attached to the human body in various ways, such as described above with reference to Figures 13 to 15B Various ways discussed. For example, the body fluid management system is attached to the chest wall of a person. At block 3904, method 3900 involves compressing and decompressing the pumping chamber when the adjustable inlet lock is in the unlocked position to provide a pumping action to prime the body fluid management system and move body fluid through the body fluid management system. Additionally, at block 3906, method 3900 involves siphoning body fluid from a body cavity through the body fluid management system after the body fluid management system is primed when the adjustable inlet lock is in the unlocked position. The body fluid can be discharged to a reservoir outside the human body.

[0269] In an example, after the fluid management system is primed and when the pumping chamber is positioned below the level of fluid in the body cavity, the fluid management system siphons fluid from the body cavity through the fluid management system. Fig.21D and Fig.25D , the pumping chambers 2110, 2510 are shown as being positioned below the level of the body fluid in the body cavity. In some examples, the tubes may be longer and the pumping chambers 2110, 2510 may be positioned higher than the body fluid level. Fig.21D and Fig.25D As shown in FIG. 2 , the pumping chamber 2110 , 2510 is further below the level of the body fluid in the body cavity. In other examples, the pumping chamber 2110 , 2510 can be positioned above the level of the body fluid in the body cavity.

[0270] In some examples, the location at which the pumping chamber is placed relative to the level of fluid in the body to facilitate siphoning may vary depending on the body cavity being drained. For example, the location at which the pumping chamber is placed relative to the level of fluid in the body to facilitate siphoning may be different for a first body cavity (e.g., the pleural cavity) than for a second body cavity (e.g., a cystic lesion in the abdomen). In this regard, for the pleural space, the chest wall tends to rebound outward, and the lungs tend to rebound inward. As the pleural fluid drains and the pleural space begins to become free of fluid, this tends to create a negative pressure. In some patients with significant pleural scarring, lung recoil may be exaggerated, and lung recoil (and therefore negative pressure) may be even worse. In this case, the pumping chamber outlet may need to be at least 1 cm H below the level of the fluid. 2 O measures the amount of vacuum (assuming the pleural fluid density is equal or substantially equal to the density of water). On the other hand, for the abdomen, the pressure tends to be positive, so the pumping chamber outlet may not need to be below the level of the body fluid to facilitate siphoning.

[0271] Thus, in some examples, the tip can be positioned at any level where the hydrostatic pressure column of bodily fluid above the pumping chamber outlet is sufficient to overcome any potential negative pressure (vacuum) in the body cavity. Thus, in some examples, method 3900 involves siphoning bodily fluid from a body cavity through the bodily fluid management system after the bodily fluid management system is primed and when at least a portion of the pumping chamber (e.g., the tip or distal end of the pumping chamber) is positioned at a level where the hydrostatic pressure column of bodily fluid above the pumping chamber outlet is sufficient to overcome any potential negative pressure (vacuum) in the body cavity.

[0272] The present disclosure includes example implementations according to the following clauses:

[0273] Item 1. A body fluid management system, comprising: a valve assembly; and a tube for transporting body fluid from a human body cavity to the valve assembly, wherein the valve assembly is configured to be positioned outside the human body and comprises: (i) an inlet; (ii) an outlet; (iii) one or more one-way valves positioned between the inlet and the outlet, each of the one or more one-way valves being configured to open and close based on pressure fluctuations between the human body cavity and the one-way valve; and (iv) an adjustable outlet lock configured to selectively prevent body fluid from moving through the outlet.

[0274] Clause 2. The bodily fluid management system of Clause 1, wherein pressure fluctuations between the cavity and the one or more one-way valves occur based on a breathing action of the person's breathing cycle.

[0275] Item 3. A body fluid management system according to Item 2, wherein each of the one or more one-way valves is configured to (i) open due to a positive pressure between the cavity and the one-way valve during an expiratory phase of the respiratory cycle, and (ii) close due to a negative pressure between the cavity and the one-way valve during an inspiratory phase of the respiratory cycle.

[0276] Clause 4. A bodily fluid management system according to any one of clauses 1 to 3, wherein each of the one or more one-way valves is configured to be less than about 25 cmH 2 Opening pressure of O.

[0277] Clause 5. A body fluid management system according to clause 4, wherein the opening pressure is less than about 5 cmH 2 O.

[0278] Clause 6. The bodily fluid management system of any one of Clauses 1 to 5, wherein each of the one or more one-way valves is configured to prevent reverse flow.

[0279] Clause 7. The bodily fluid management system of clause 6, wherein each of the one or more one-way valves is configured to be less than about 15 cmH 2 O reverse pressure differential reseal.

[0280] Clause 8. A body fluid management system according to clause 7, wherein the reverse pressure difference is less than about 2 cmH 2 O.

[0281] Clause 9. A bodily fluid management system according to any one of clauses 1 to 8, wherein each of the one or more one-way valves includes a plurality of lips defining a slit, the slit being capable of moving from a closed position to an open position, and wherein the lips are configured to have an interaction surface area of ​​less than 6 square millimeters when the slit is in the closed position.

[0282] Clause 10. A bodily fluid management system according to any one of clauses 1 to 9, wherein the adjustable outlet lock is located at the outlet, and wherein the adjustable outlet lock is configured to move between a locked position and an unlocked position, wherein in the locked position, the adjustable outlet lock seals the outlet, and in the unlocked position, the adjustable outlet lock allows bodily fluid to move through the outlet.

[0283] Clause 11. The bodily fluid management system of Clause 10, wherein the adjustable outlet lock comprises at least one of a cap, a pinch lever, a pinch, or a biasing device.

[0284] Clause 12. The bodily fluid management system of any one of clauses 1 to 11, wherein the valve assembly is non-removably attached to the tube.

[0285] Clause 13. A bodily fluid management system according to any one of clauses 1 to 12, wherein the valve assembly comprises a body that houses the one or more one-way valves, and wherein the body is coated with at least one of an anticoagulant factor or a fibrinolytic factor.

[0286] Clause 14. A body fluid management system according to any one of clauses 1 to 13, wherein the one or more one-way valves include a first one-way valve and a second one-way valve, wherein the valve assembly further includes a pumping chamber accommodating the first one-way valve and the second one-way valve, and wherein the pumping chamber is configured to compress and decompress to infuse the tube.

[0287] Clause 15. The bodily fluid management system of any one of clauses 1 to 14, wherein the cavity comprises one of a pleural cavity, a peritoneal cavity, a cerebrospinal cavity, a pericardial cavity, a breast cavity, or a cavity of a cystic lesion.

[0288] Item 16. A body fluid management system, comprising: a valve assembly; and a tube for transporting body fluid from a human body cavity to the valve assembly, wherein the valve assembly is configured to be positioned outside the human body and comprises: (i) an inlet; (ii) an outlet; (iii) a plurality of one-way valves, the plurality of one-way valves being positioned between the inlet and the outlet and each being configured to open and close based on pressure fluctuations between the human body cavity and the one-way valve; and (iv) an adjustable outlet lock, the adjustable outlet lock being configured to selectively prevent body fluid from moving through the outlet, and wherein the tube is configured to extend from the inlet of the valve assembly to the human body cavity.

[0289] Item 17. A body fluid management system according to Item 16, wherein the valve assembly includes a pumping chamber that accommodates the multiple one-way valves, wherein the multiple one-way valves include a first one-way valve positioned on a first side of the pumping chamber and a second one-way valve positioned on a second side of the pumping chamber, and wherein the pumping chamber is configured to be compressed and decompressed to infuse the tube.

[0290] Item 18. A body fluid management system according to Item 16 or Item 17, wherein each of the plurality of one-way valves is configured to (i) open due to a positive pressure between the cavity and the one-way valve during an expiratory phase of a respiratory cycle, and (ii) close due to a negative pressure between the cavity and the one-way valve during an inspiratory phase of the respiratory cycle.

[0291] Clause 19. A bodily fluid management system according to any one of clauses 16 to 18, wherein each one-way valve is configured to be less than about 25 cmH 2 O, and each one-way valve is configured to open at a cracking pressure of less than about 15 cmH 2 O reverse pressure differential reseal.

[0292] Item 20. A method of operating a body fluid management system, the body fluid management system comprising a valve assembly and a tube for transporting body fluid from a body cavity of a person to the valve assembly, wherein the valve assembly is positioned outside the human body and comprises: (i) an inlet; (ii) an outlet; (iii) a plurality of one-way valves located between the inlet and the outlet, each one-way valve being configured to open and close based on pressure fluctuations between the body cavity of the person and the one-way valve, wherein the plurality of one-way valves are housed in a pumping chamber; and (iv) an adjustable outlet lock, the adjustable outlet lock being configured to selectively prevent body fluid from moving through the outlet, the method comprising: when the adjustable outlet lock is in a locked position, an external portion of the body fluid management system is attached to the body of the person; and when the adjustable outlet lock is in an unlocked position, (i) the pumping chamber is compressed and decompressed to provide a pumping action to prime the body fluid management system and move body fluid through the body fluid management system, and (ii) after priming the body fluid management system and when the pumping chamber is positioned below the level of body fluid in the body cavity, the body fluid management system siphons body fluid from the body cavity through the body fluid management system.

[0293] Item 21. A body fluid management system, comprising: a valve assembly; and a tube for transporting body fluid from a human body cavity to the valve assembly, wherein the valve assembly is configured to be positioned outside the human body and comprises: (i) an inlet; (ii) an outlet; (iii) a pumping chamber between the inlet and the outlet and configured to be compressed and decompressed to pump body fluid; (iv) a first one-way valve positioned on a first side of the pumping chamber; (v) a second one-way valve positioned on a second side of the pumping chamber; and (vi) an adjustable inlet lock configured to selectively prevent body fluid from moving through the inlet, and wherein the tube is configured to extend from the inlet of the valve assembly to the human body cavity.

[0294] Clause 22. The bodily fluid management system of Clause 21, wherein the adjustable inlet lock is located upstream of the first one-way valve.

[0295] Clause 23. The bodily fluid management system of Clause 21 or Clause 22, further comprising an adjustable outlet lock configured to selectively prevent bodily fluid from moving through the outlet.

[0296] Clause 24. The bodily fluid management system of Clause 23, wherein the adjustable outlet lock is located downstream of the second one-way valve.

[0297] Clause 25. A bodily fluid management system according to any one of clauses 21 to 24, wherein the pumping chamber is configured to be compressed and to rebound with a maximum rebound pressure, and wherein at least one of the shape of the pumping chamber or the thickness of the wall of the pumping chamber is selected based on the maximum rebound pressure.

[0298] Clause 26. A body fluid management system according to any one of Clauses 21 to 24, wherein the pumping chamber includes a first region and a second region, the first region being configured to be compressed and rebound at a first pressure, and the second region being configured to be compressed and rebound at a second pressure different from the first pressure.

[0299] Clause 27. The bodily fluid management system of Clause 26, wherein the thickness of the first region is selected based on the first pressure, and wherein the thickness of the second region is selected based on the second pressure.

[0300] Clause 28. The bodily fluid management system of any one of Clauses 21 to 27, wherein the valve assembly comprises one or more of a pumping chamber access port and an inlet access port.

[0301] Item 29. A bodily fluid management system according to Item 28, wherein the valve assembly includes the pumping chamber access port, wherein the pumping chamber access port includes a thickened area in the wall of the pumping chamber, and wherein the pumping chamber also includes puncture-resistant material in an area of ​​the wall located opposite the pumping chamber access port.

[0302] Clause 30. A bodily fluid management system according to Clause 28 or Clause 29, wherein the valve assembly includes the inlet access port, wherein the inlet access port includes a thickened area in the wall of the valve assembly, and wherein the valve assembly also includes puncture-resistant material in an area of ​​the wall located opposite the inlet access port.

[0303] Clause 31. A bodily fluid management system according to any one of clauses 21 to 30, wherein the pumping chamber comprises a plurality of first protrusions and a plurality of second protrusions, and wherein the plurality of first protrusions are configured to interweave with the plurality of second protrusions during compression of the pumping chamber.

[0304] Clause 32. A bodily fluid management system according to any one of clauses 21 to 31, wherein each of the first one-way valve and the second one-way valve includes a plurality of lips defining a slit, the slit being capable of moving from a closed position to an open position, and wherein the lips are configured to have an interaction surface area of ​​less than 6 square millimeters when the slit is in the closed position.

[0305] Clause 33. A bodily fluid management system as described in any one of Clauses 21 to 32, wherein the valve assembly is non-removably attached to the tube, and wherein the adjustable inlet lock of the valve assembly is non-removably attached to the valve assembly.

[0306] Clause 34. The bodily fluid management system of any one of Clauses 21 to 33, wherein each of the first and second one-way valves is configured to open and close based on compression and decompression of the pumping chamber.

[0307] Item 35. A body fluid management system according to Item 34, wherein each of the first one-way valve and the second one-way valve is further configured to open and close based on pressure fluctuations between the person's body cavity and the one-way valve, the pressure fluctuations occurring based on the breathing action of the person's breathing cycle.

[0308] Clause 36. The bodily fluid management system of any one of Clauses 21 to 35, wherein the body cavity comprises one of a pleural cavity, a peritoneal cavity, a cerebrospinal cavity, a pericardial cavity, a breast cavity, or a cavity of a cystic lesion.

[0309] Item 37. A body fluid management system, comprising: a valve assembly; and a tube for transporting body fluid from a human body cavity to the valve assembly, wherein the valve assembly is configured to be positioned outside the human body and comprises: (i) an inlet; (ii) an outlet; (iii) a pumping chamber between the inlet and the outlet and configured to be compressed and decompressed to pump body fluid; (iv) a first one-way valve positioned on a first side of the pumping chamber; (v) a second one-way valve positioned on a second side of the pumping chamber; (vi) an adjustable inlet lock configured to selectively prevent body fluid from moving through the inlet, and wherein the tube is configured to extend from the inlet of the valve assembly to the human body cavity; and (vii) an adjustable outlet lock configured to selectively prevent body fluid from moving through the outlet, wherein the adjustable inlet lock is positioned upstream of the first one-way valve, and wherein the adjustable outlet lock is positioned downstream of the second one-way valve.

[0310] Clause 38. The bodily fluid management system of Clause 37, wherein the valve assembly comprises a pumping chamber access port and an inlet access port.

[0311] Item 39. A body fluid management system according to Item 37 or Item 38, further comprising an adjustable tube lock configured to lock the tube at a point outside the human body and upstream of the valve assembly, wherein the valve assembly is irremovably attached to the tube, wherein the adjustable inlet lock of the valve assembly is irremovably attached to the valve assembly, wherein the adjustable outlet lock of the valve assembly is irremovably attached to the valve assembly, and wherein the adjustable tube lock is irremovably attached to the tube.

[0312] Clause 40. A method of operating a body fluid management system, the body fluid management system comprising a valve assembly and a tube for conveying body fluid from a body cavity of a person to the valve assembly, wherein the valve assembly is positioned outside the human body and comprises: (i) an inlet; (ii) an outlet; (iii) a pumping chamber, the pumping chamber being between the inlet and the outlet and being configured to be compressed and decompressed to pump body fluid; (iv) a first one-way valve positioned on a first side of the pumping chamber; (v) a second one-way valve positioned on a second side of the pumping chamber; (vi) an adjustable inlet lock, which is configured to Selectively preventing body fluid from moving through an inlet, and wherein the tube is configured to extend from the inlet of the valve assembly to a body cavity of a person, the method comprising: when an adjustable inlet lock is in a locked position, an external portion of the body fluid management system is attached to the body of the person; and when the adjustable inlet lock is in an unlocked position, (i) a pumping chamber is compressed and decompressed to provide a pumping action to prime the body fluid management system and move body fluid through the body fluid management system, and (ii) after priming the body fluid management system, the body fluid management system siphons body fluid from the body cavity through the body fluid management system.

[0313] Example implementations of the disclosed innovations have been described above. However, those skilled in the art will appreciate that changes and modifications may be made to the described implementations without departing from the true scope and spirit of the invention, which will be defined by the claims. Furthermore, to the extent that the examples described herein involve operations performed or initiated by an actor, such as a "person" or other entity, this is for purposes of example and explanation only. The claims should not be interpreted as requiring such an actor to take an action unless explicitly recited in the claim language.

Claims

1. A body fluid management system, comprising: Valve assembly; as well as a tube for conveying body fluid from a body cavity of a person to the valve assembly, The valve assembly is configured to be positioned outside the human body and includes: (i) an inlet; (ii) an outlet; (iii) one or more one-way valves positioned between the inlet and the outlet, each one-way valve being configured to open and close based on pressure fluctuations between the human body cavity and the one-way valve; and (iv) an adjustable outlet lock, the adjustable outlet lock being configured to selectively prevent body fluids from moving through the outlet.

2. The body fluid management system according to claim 1, wherein: Pressure fluctuations between the cavity and the one or more one-way valves occur based on the breathing action of the person's breathing cycle.

3. The body fluid management system according to claim 2, wherein: Each of the one or more one-way valves is configured to (i) open due to positive pressure between the cavity and the one-way valve during an expiratory phase of the breathing cycle, and (ii) close due to negative pressure between the cavity and the one-way valve during an inspiratory phase of the breathing cycle.

4. The body fluid management system according to claim 1, wherein: Each of the one or more one-way valves is configured to open at a cracking pressure of less than about 25 cmH2O.

5. The body fluid management system according to claim 4, wherein: The cracking pressure is less than about 5 cmH2O.

6. The body fluid management system according to claim 1, wherein: Each of the one or more one-way valves is configured to prevent reverse flow.

7. The body fluid management system according to claim 6, wherein: Each of the one or more one-way valves is configured to reseal at a back pressure differential of less than about 15 cmH2O.

8. The body fluid management system according to claim 7, wherein: The back pressure difference is less than about 2 cmH2O.

9. The body fluid management system according to claim 1, wherein: Each of the one or more one-way valves includes a plurality of lips defining a slit, the slit being movable from a closed position to an open position, and wherein the lips are configured to have an interaction surface area of ​​less than 6 square millimeters when the slit is in the closed position.

10. The body fluid management system according to claim 1, wherein: The adjustable outlet lock is located at the outlet, and wherein the adjustable outlet lock is configured to move between a locked position and an unlocked position, wherein the adjustable outlet lock seals the outlet and wherein the adjustable outlet lock allows body fluids to move through the outlet.

11. The body fluid management system according to claim 10, wherein: The adjustable outlet lock includes at least one of a cap, a pinch lever, a pinch, or a biasing device.

12. The body fluid management system according to claim 1, wherein: The valve assembly is non-removably attached to the tube.

13. The body fluid management system according to claim 1, wherein: The valve assembly includes a body housing the one or more one-way valves, and wherein the body is coated with at least one of an anticoagulant factor or a fibrinolytic factor.

14. The body fluid management system according to claim 1, wherein: The one or more one-way valves include a first one-way valve and a second one-way valve, wherein the valve assembly further includes a pumping chamber accommodating the first one-way valve and the second one-way valve, and wherein the pumping chamber is configured to be compressed and decompressed to prime the tube.

15. The body fluid management system according to claim 1, wherein: The cavity includes one of the pleural cavity, the peritoneal cavity, the cerebrospinal cavity, the pericardial cavity, the breast cavity, or the cavity of a cystic lesion.

16. A body fluid management system, comprising: Valve assembly; as well as A tube for transporting body fluids from a body cavity of a person to the valve assembly, wherein the valve assembly is configured to be positioned outside the human body and comprises: (i) an inlet; (ii) an outlet; (iii) a plurality of one-way valves positioned between the inlet and the outlet, each of the plurality of one-way valves being configured to open and close based on pressure fluctuations between the body cavity of the person and the one-way valve; and (iv) an adjustable outlet lock configured to selectively prevent body fluids from moving through the outlet, and wherein the tube is configured to extend from the inlet of the valve assembly to the body cavity of the person.

17. The body fluid management system according to claim 16, wherein: The valve assembly includes a pumping chamber that accommodates the plurality of one-way valves, wherein the plurality of one-way valves include a first one-way valve positioned on a first side of the pumping chamber and a second one-way valve positioned on a second side of the pumping chamber, and wherein the pumping chamber is configured to be compressed and decompressed to prime the tube.

18. The body fluid management system according to claim 16, wherein: Each of the plurality of one-way valves is configured to (i) open due to a positive pressure between the cavity and the one-way valve during an exhalation phase of a breathing cycle, and (ii) close due to a negative pressure between the cavity and the one-way valve during an inhalation phase of the breathing cycle.

19. The body fluid management system according to claim 16, wherein: Each one-way valve is configured to open at a cracking pressure of less than about 25 cmH2O, and each one-way valve is configured to reseal at a back pressure differential of less than about 15 cmH2O.

20. A method of operating a body fluid management system comprising a valve assembly and a tube for conveying body fluid from a body cavity of a person to the valve assembly, wherein: The valve assembly is positioned outside of a human body and includes: (i) an inlet; (ii) an outlet; (iii) a plurality of one-way valves positioned between the inlet and the outlet, each of the plurality of one-way valves being configured to open and close based on pressure fluctuations between the body cavity of a person and the one-way valve, wherein the plurality of one-way valves are housed in a pumping chamber; and (iv) an adjustable outlet lock configured to selectively prevent body fluid from moving through the outlet, the method comprising: the external portion of the bodily fluid management system being attached to a person's body when the adjustable exit lock is in a locked position; and When the adjustable outlet lock is in the unlocked position, (i) the pumping chamber compresses and decompresses to provide a pumping action to prime the body fluid management system and move body fluid through the body fluid management system, and (ii) after priming the body fluid management system and when the pumping chamber is positioned below the level of body fluid in the body cavity, the body fluid management system siphons body fluid from the body cavity through the body fluid management system.

21. A body fluid management system, comprising: Valve assembly; as well as A tube for transporting body fluid from a body cavity of a person to the valve assembly, wherein the valve assembly is configured to be positioned outside the human body and includes: (i) an inlet; (ii) an outlet; (iii) a pumping chamber between the inlet and the outlet and configured to compress and decompress to pump body fluid; (iv) a first one-way valve positioned on a first side of the pumping chamber; (v) a second one-way valve positioned on a second side of the pumping chamber; and (vi) an adjustable inlet lock configured to selectively prevent body fluid from moving through the inlet, and wherein the tube is configured to extend from the inlet of the valve assembly to the body cavity of the person.

22. The body fluid management system according to claim 21, wherein: The adjustable inlet lock is positioned upstream of the first one-way valve.

23. The bodily fluid management system of claim 21, further comprising an adjustable outlet lock configured to selectively prevent bodily fluid from moving through the outlet.

24. The body fluid management system according to claim 23, wherein: The adjustable outlet lock is positioned downstream of the second one-way valve.

25. The body fluid management system according to claim 21, wherein: The pumping chamber is configured to be compressed and to rebound at a maximum rebound pressure, and wherein at least one of a shape of the pumping chamber or a thickness of a wall of the pumping chamber is selected based on the maximum rebound pressure.

26. The body fluid management system according to claim 21, wherein: The pumping chamber includes a first region configured to compress and rebound at a first pressure and a second region configured to compress and rebound at a second pressure different from the first pressure.

27. The body fluid management system according to claim 26, wherein: The thickness of the first region is selected based on the first pressure, and wherein the thickness of the second region is selected based on the second pressure.

28. The body fluid management system according to claim 21, wherein: The valve assembly includes one or more of a pumping chamber access port and an inlet access port.

29. The body fluid management system according to claim 28, wherein: The valve assembly includes the pumping chamber access port, wherein the pumping chamber access port includes a thickened area in a wall of the pumping chamber, and wherein the pumping chamber further includes puncture-resistant material in an area of ​​the wall located opposite the pumping chamber access port.

30. The body fluid management system according to claim 28, wherein: The valve assembly comprises the inlet access port, wherein the inlet access port comprises a thickened area in a wall of the valve assembly, and wherein the valve assembly further comprises a puncture-resistant material in an area of ​​the wall opposite the inlet access port.

31. The body fluid management system according to claim 21, wherein: The pumping chamber includes a plurality of first protrusions and a plurality of second protrusions, and wherein the plurality of first protrusions are configured to interweave with the plurality of second protrusions during compression of the pumping chamber.

32. The body fluid management system according to claim 21, wherein: Each of the first and second one-way valves includes a plurality of lips defining a slit, the slit being movable from a closed position to an open position, and wherein the lips are configured to have an interaction surface area of ​​less than 6 square millimeters when the slit is in the closed position.

33. The body fluid management system according to claim 21, wherein: The valve assembly is non-removably attached to the tube, and wherein the adjustable inlet lock of the valve assembly is non-removably attached to the valve assembly.

34. The body fluid management system according to claim 21, wherein: Each of the first and second one-way valves is configured to open and close based on compression and decompression of the pumping chamber.

35. The body fluid management system according to claim 34, wherein: Each of the first and second one-way valves is also configured to open and close based on pressure fluctuations between the body cavity of the person and the one-way valve, the pressure fluctuations occurring based on a breathing action of a breathing cycle of the person.

36. The body fluid management system according to claim 21, wherein: The body cavity includes one of the pleural cavity, the peritoneal cavity, the cerebrospinal cavity, the pericardial cavity, the breast cavity, or the cavity of a cystic lesion.

37. A body fluid management system, comprising: Valve assembly; as well as A tube for conveying bodily fluid from a body cavity of a person to the valve assembly, wherein the valve assembly is configured to be positioned outside the human body and includes: (i) an inlet; (ii) an outlet; (iii) a pumping chamber between the inlet and the outlet and configured to compress and decompress to pump the bodily fluid; (iv) a first one-way valve positioned on a first side of the pumping chamber; (v) a second one-way valve positioned on a second side of the pumping chamber; (vi) an adjustable inlet lock configured to selectively prevent bodily fluid from moving through the inlet, and wherein the tube is configured to extend from the inlet of the valve assembly to the body cavity of the person; and (vii) an adjustable outlet lock configured to selectively prevent bodily fluid from moving through the outlet, wherein the adjustable inlet lock is positioned upstream of the first one-way valve, and wherein the adjustable outlet lock is positioned downstream of the second one-way valve.

38. The body fluid management system according to claim 37, wherein: The valve assembly includes a pumping chamber access port and an inlet access port.

39. The body fluid management system of claim 37, further comprising an adjustable tube lock configured to lock the tube at a point external to the human body and upstream of the valve assembly, in, The valve assembly is non-removably attached to the tube, wherein the adjustable inlet lock of the valve assembly is non-removably attached to the valve assembly, wherein the adjustable outlet lock of the valve assembly is non-removably attached to the valve assembly, and Wherein, the adjustable tube lock is non-removably attached to the tube.

40. A method of operating a body fluid management system comprising a valve assembly and a tube for conveying body fluid from a body cavity of a person to the valve assembly, wherein: The valve assembly is positioned outside the human body and includes: (i) an inlet; (ii) an outlet; (iii) a pumping chamber between the inlet and the outlet and configured to be compressed and decompressed to pump body fluid; (iv) a first one-way valve positioned on a first side of the pumping chamber; (v) a second one-way valve positioned on a second side of the pumping chamber; and (vi) an adjustable inlet lock configured to selectively prevent body fluid from moving through the inlet, and wherein the tube is configured to extend from the inlet of the valve assembly to the body cavity of the person, the method comprising: When the adjustable access lock is in the locked position, the external portion of the bodily fluid management system is attached to a human body; and When the adjustable inlet lock is in the unlocked position, (i) the pumping chamber compresses and decompresses to provide a pumping action to prime the body fluid management system and move body fluid through the body fluid management system, and (ii) after the body fluid management system is primed, the body fluid management system siphons body fluid from the body cavity through the body fluid management system.

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