Automatic pleural and peritoneal pumps

Abstract

An automatic pump-based fluid management system as described herein includes an intercostal pump, which is typically a resilient, flexible tube having an inlet and an outlet. The inlet is attached to a first tube that extends from the intercostal pump to a first region of a patient's body, such as the patient's pleural cavity. The outlet is connected to a second tube that extends from the intercostal pump to a second region of the patient's body, such as the patient's peritoneal cavity. During use, the intercostal pump is positioned between a first and second rib of the patient. The intercostal pump operates by continuously compressing and decompressing the space between the first and second ribs during the patient's breathing.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of priority to U.S. patent application No. 16 / 819,352, filed on March 16, 2020, entitled “Automatic Pleural-Peritonal Pump,” the entire disclosure of which is hereby incorporated by reference.

[0003] This application is also related to U.S. patent application Ser. No. 13 / 968,479, filed on Aug. 16, 2013, entitled “Systems and Methods for Draining Bodily Fluid via an Intercostal Pump,” the entire disclosure of which is hereby incorporated by reference. Background Art

[0004] Many techniques for draining fluids involve the use of a pump in conjunction with a shunt or catheter to drain fluid from one cavity in the body to another or to a reservoir outside the body. Such techniques can be used for purposes including, for example, draining a patient's blood, urine, saliva, cerebrospinal fluid, peritoneal fluid, and / or pleural fluid, among other possibilities.

[0005] One application of drainage technology is the drainage of pleural fluid for the treatment of pleural effusion. Pleural fluid is typically a low-protein fluid found in relatively small amounts (typically 10 to 20 milliliters) in each of the patient's pleural cavities. The pleural cavity is the space between the visceral pleura (i.e., the membrane over the entire outer surface of each lung) and the parietal pleura (i.e., the membrane formed on the inside of the chest wall of each hemithorax). The small amount of pleural fluid in each pleural space is very thinly distributed between the visceral pleura and the parietal pleura, thereby providing a large surface tension. The pleural fluid mechanically couples the lungs to the chest wall and lubricates these surfaces, allowing the lungs to slide on the chest wall during the respiratory process. In normal, healthy people, pleural fluid is continuously produced, primarily from fluid leaking from the blood and lymphatic vessels in the visceral pleura covering the outer surface of the lungs, and is reabsorbed by the lymphatic vessels in the parietal pleura formed on the chest wall at substantially the same rate. This dynamic balance exchanges fluid several times a day and maintains a low total volume within the range of 10 to 20 milliliters. However, in certain abnormal conditions such as infection, inflammation, malignancy, heart failure, liver failure, or renal failure, among others, the net flow of pleural fluid within the pleural cavity becomes unbalanced, with increased fluid production, decreased reabsorption, or both, leading to an excessive accumulation of fluid in the pleural space (e.g., on the order of several hundred milliliters to several liters).

[0006] Excessive accumulation of pleural fluid is known as a pleural effusion, and it adds extra mass that must be moved with each breath and can lead to pathological compression of lung tissue. This makes breathing difficult or even prevents it. Pleural effusions can cause, for example, dyspnea, shortness of breath, chest pain, and / or a chronic cough, and can significantly impact a patient's quality of life.

[0007] Currently, pleural effusions affect approximately 1.5 million new patients each year in the United States. Many of these effusions are chronic, recur if drained, and can be quite symptomatic and debilitating for the patient. One common type of recurrent symptomatic pleural effusion is the result of malignancy. In the United States, over 200,000 cases of malignant pleural effusion occur each year, and over half of these patients with malignant pleural effusions experience recurrent symptoms directly caused by their effusion.

[0008] Treatment options for recurrent, symptomatic pleural effusions can be divided into: 1) repeated drainage of the pleural effusion and; 2) obliteration of the pleural space.

[0009] One approach to treating recurrent, symptomatic pleural effusions is repeated therapeutic thoracentesis. Thoracentesis involves inserting a needle and catheter into the pleural space, at which point the needle is removed, leaving the catheter in the pleural space. The catheter remains in place and thus acts as a drain, allowing excess pleural fluid to be moved from the pleural space to a collection reservoir outside the body. This procedure typically significantly improves symptoms. Unfortunately, malignant effusions are likely to recur after drainage, and therapeutic thoracentesis must be repeated frequently to control symptoms. However, because patients delay notifying their doctors that their symptoms have returned and delay organizing and providing repeat thoracentesis, patients often experience effusion-related symptoms for most of their lives. In addition, thoracentesis is painful and uncomfortable, and is often accompanied by complications, such as pneumothorax (i.e., collapse of the lung due to accumulation of air in the pleural space) in up to 11% of patients, and severe bleeding or infection in many other patients.

[0010] Another treatment option is pleurodesis. Pleurodesis involves instilling a sclerosing agent into the pleural space to occlude the space and adhere the visceral and parietal pleural surfaces. In one approach, the sclerosing agent is introduced via a chest tube, which is inserted into the patient under moderate sedation or general anesthesia to drain the pleural fluid in a manner similar to the drainage achieved during thoracentesis. After draining the pleural effusion, a sclerosing agent is instilled into the pleural space through the tube to completely cover the visceral and parietal membranes so that these membranes will permanently adhere to each other, sealing and obliterating the pleural space. Chest tube pleurodesis can sometimes result in long-term control of effusion-related symptoms. Unfortunately, chest tube pleurodesis typically requires a hospital stay of at least 2 days and up to 7 days, can be quite painful, may cause pleurodesis-related dyspnea, and in up to one-third of patients, fails to provide symptom relief for more than a few weeks.

[0011] Another variation of pleurodesis is thoracoscopic pleurodesis, which involves inserting a telescope into the patient's chest through an intercostal incision on one side of the patient. The pleural fluid is drained, and the pleural space is examined in detail to allow for more selective application of sclerosing agents to abnormal areas. In some cases, thoracoscopic pleurodesis can achieve better results than chest tube pleurodesis. Unfortunately, thoracoscopic pleurodesis still typically requires an extended hospital stay of 4 to 7 days, can be quite painful, can cause pleurodesis-related dyspnea, and in many patients, fails to provide symptom relief for more than a few weeks.

[0012] Yet another treatment option is a long-term indwelling pleural catheter. Such an indwelling catheter is permanently placed in the patient's body, allowing the patient to drain pleural fluid to an external reservoir on an intermittent but continuous basis. Specifically, one end of the pleural catheter is placed in the affected pleural space within the patient's body, while the other end of the catheter extends outside the patient's body and remains exposed for an extended period. Chronic indwelling catheters have been shown to have a relatively high success rate in treating effusion-related symptoms and involve a relatively short patient hospital stay of approximately one day. However, because the catheter passes through the patient's skin, partially inside and partially outside the body, a significant proportion of patients, approximately 8%, fall victim to infection. Furthermore, patients experience the discomfort, irritation, and annoyance of an exposed indwelling catheter. Finally, to achieve relief of effusion-related symptoms, the patient or their caregiver must actively access the external portion of the catheter, connect it to the external reservoir, and drain exudate from the pleural space into the reservoir.

[0013] Another approach is a pleuroperitoneal shunt. A pleuroperitoneal shunt provides a permanent conduit between the pleural and peritoneal cavities, or abdomen, allowing fluid to move from the pleural to the peritoneal cavity, as opposed to an external reservoir. Once in the peritoneal cavity, the fluid is reabsorbed into the patient's bloodstream via the blood and lymphatic vessels located in the abdomen. In popular pleuroperitoneal shunts, the shunt has a pump chamber that must be manually activated by the patient or a caregiver to move the pleural fluid. The shunt is threaded under the skin from the chest to the abdomen, with the pump chamber embedded in a subcutaneous bag overlying the chest cavity. Like long-term indwelling catheters, pleuroperitoneal shunts have been shown to have a relatively high success rate in treating effusion-related symptoms and involve a relatively short patient hospital stay of approximately one day. However, also like long-term indwelling catheters, a significant proportion of patients, approximately 4%, become victims of infection. Other disadvantages of conventional pleuroperitoneal shunts include a relatively high incidence of shunt-specific complications, such as clotting of fluid within the shunt. Finally, to obtain relief from effusion-related symptoms, the patient or the patient's caregiver must actively and repeatedly compress the pump chamber multiple times to shift the exudate from the pleural space to the peritoneal space, causing significant discomfort and inconvenience.

[0014] There are other drainage technology applications. These technology applications include, but are not limited to, drainage of pericardial fluid, cerebrospinal fluid, peritoneal fluid, urine, bile, and lymph. The cavities into which these fluids can be drained include, but are not limited to, the pleural space, the peritoneal space, the bile duct, the stomach, the lymphatic vessels including the thoracic duct, the veins including the vena cava, and the bladder.

[0015] The background description provided herein is for the purpose of generally presenting the context of the present disclosure. To the extent described in this background section, the work of the presently designated inventors and aspects of the description that may not otherwise qualify as prior art at the time the application was filed are neither explicitly nor implicitly admitted to be prior art against the present disclosure. Summary of the Invention

[0016] There is a need for a new pleural fluid drainage technology that provides a high success rate in treating pleural effusions, avoids high infection rates and other complications, does not require lengthy patient hospital stays and / or repeated hospital visits, and avoids the inconvenience of manually compressing the pump chamber multiple times daily or physically connecting a catheter to an external reservoir to relieve symptoms. The automated pump-based fluid management system described herein provides such a novel and beneficial drainage technology.

[0017] As described herein, the fluid management system based on automatic pump comprises a pump, which is typically a pump chamber, which has a first one-way valve at the inlet leading to the pump chamber and a second one-way valve at the outlet of the pump chamber connected in series with the first valve. The volume of the pump chamber in contact with the fluid can increase or decrease. The inlet is attached to a first tube, which extends from the automatic pump to a first area of ​​the patient's body, such as the patient's pleural cavity. The outlet is connected to a second tube, which extends from the automatic pump to a second area of ​​the patient's body. The second area of ​​the patient's body can be, for example, the patient's peritoneal cavity. When the automatic pump is running, the fluid is transferred from the first area of ​​the patient's body to the second area.

[0018] In one embodiment, the pump chamber of the automatic pump is an elastic flexible tube and is positioned between the patient's first and second ribs. (Note that although the terms "first rib" and "second rib" are used herein, it should be understood that such usage does not necessarily refer to any specific two ribs. For example, "first" and "second" ribs, in an anatomical context, generally refer to the two ribs closest to the patient's skull.) The automatic pump operates by continuously compressing and decompressing the pump chamber between the first and second ribs as the patient breathes, thereby cyclically changing the volume of the pump chamber. When the patient inhales, the patient's chest cavity expands, the intercostal space (or the space between the first and second ribs) increases, and the pump chamber decompresses. When the patient exhales, the patient's chest cavity contracts, the intercostal space narrows, and the pump chamber is compressed. For a person breathing 12 times per minute, this means that the pump chamber is compressed and decompressed 17,280 times per day.

[0019] In another embodiment, the pump chamber of the automatic pump is an elongated, resilient, flexible tube, wherein a portion of the pump chamber is positioned between the patient's first and second ribs, and a second portion of the elongated pump chamber is positioned in the subcutaneous tissue between the patient's chest and skin. Thus, the automatic pump can operate in two ways: first, the pump chamber is continuously compressed and decompressed between the first and second ribs as the patient breathes, thereby cyclically changing the volume of the pump chamber; and second, the patient or a caregiver manually compresses the portion of the elongated pump chamber located between the patient's chest and skin. Thus, when the patient inhales, the portion of the pump chamber located between the first and second ribs is decompressed, and when the patient exhales, the portion of the pump chamber is compressed, thereby providing automatic pumping. Furthermore, if the presence of excessive exudate in the pleural space is determined based on patient symptoms, radiography, or ultrasound, the patient or caregiver may repeatedly manually compress the portion of the pump chamber located between the patient's or caregiver's fingers or hands and the chest to provide additional pumping action.

[0020] In yet another embodiment, the pump chamber of the automatic pump comprises a first portion and a second portion. The first portion comprises an elastically flexible tube positioned between the first and second ribs of the patient, and the second portion comprises a semi-rigid chamber containing an electromechanical pump that assists the pumping action provided by the first portion. Thus, the automatic pump can operate as follows: first, as the patient breathes, the first portion of the pump chamber is continuously compressed and decompressed between the first and second ribs, thereby periodically varying the volume of the pump chamber and the volume of the pump chamber generated by the electromechanical pump in the second portion. Thus, when the patient inhales, the first portion of the pump chamber between the first and second ribs is decompressed, filling with exudate from the pleural space. When the patient exhales, the first portion of the pump chamber is compressed, pushing fluid out of the pump chamber into the peritoneal space. The electromechanical pump in the second portion can also pump fluid from the pleural space to the peritoneal space, independent of the action of the pump chamber between the first and second ribs.

[0021] The use of an automated pump as described herein avoids certain drawbacks of known fluid drainage techniques. For example, the intercostal pump operates to drain fluid regularly, continuously, and automatically, without requiring the patient to manually depress the pump or requiring the patient to drain the fluid externally. Furthermore, due to the continuous operation of the intercostal pump, improved performance can be achieved by reducing the occurrence of clots observed in other fluid drainage systems that may remain inactive for extended periods of time.

[0022] The foregoing presents a simplified overview of one or more embodiments of the present disclosure in order to provide a basic understanding of such embodiments. This overview is not a broad overview of all contemplated embodiments and is neither intended to identify the key or key elements of all embodiments nor to describe the scope of any or all embodiments. Other embodiments of the present disclosure will become apparent to those skilled in the art through the following detailed description, which shows and describes illustrative embodiments of the present invention. As will be appreciated, the various embodiments of the present disclosure can be modified in various obvious aspects, all of which do not depart from the scope of the present disclosure. Therefore, the drawings and detailed description are considered to be illustrative and non-restrictive in nature. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] The invention disclosed herein will be more readily understood by reading the specification with reference to the accompanying drawings which form a part thereof and in which:

[0024] Figure 1 shows a perspective view of an automatic pump-based fluid management system including a pump and also including an inlet tube and an outlet tube (the inlet tube and the outlet tube are schematically shown shortened for illustrative purposes);

[0025] Figure 2A、 Figure 2B and Figure 2C An automated pump-based fluid management system implanted in a patient is shown;

[0026] Figure 3 Representative pleural and peritoneal pressures that change during inspiration and expiration are shown;

[0027] Figure 4 shows a perspective view of an automatic pump-based fluid management system including a pump and also including inlet and outlet tubes having perforations or fenestrations designed to prevent clogging and improve fluid flow (the inlet and outlet tubes are schematically shown shortened for illustrative purposes);

[0028] Figure 5 shows a perspective view of an automated pump-based fluid management system comprising a pump and also including an inlet tube and an outlet tube (the inlet and outlet tubes are schematically shown shortened for illustrative purposes), the inlet tube having rounded and closed ends and a small fenestration designed to prevent fibrin strands and microparticles from entering the catheter and pump and thereby preventing occlusion of the system;

[0029] Figure 6 shows a perspective view of an automated pump-based fluid management system including a pump, perforated or fenestrated inlet and outlet tubes (the inlet and outlet tubes are schematically shown shortened for illustrative purposes), and a fibrinolytic and / or anticoagulant material band on the inlet tube to prevent fibrin and / or clot formation and thereby prevent clogging of the system;

[0030] Figure 7 shows a perspective view of an automated pump-based fluid management system including a pump, perforated or fenestrated inlet and outlet tubes (the inlet and outlet tubes are schematically shown shortened for illustrative purposes), and a strip of pro-fibrotic material on the inlet tube to induce localized fibrin and / or clot formation away from the fenestrations and thereby prevent system clogging;

[0031] Figure 8A shows a perspective view of an automatic intercostal pump-based fluid management system for intercostal use and comprising a pump chamber and including perforated or fenestrated inlet and outlet tubes (the inlet and outlet tubes are schematically shown shortened for illustrative purposes);

[0032] Figure 8BA perspective view of an automatic intercostal pump-based fluid management system for intercostal use is shown, and includes a pump chamber and an inlet tube having a linear fluid passage and a perforated or fenestrated outlet tube (the inlet and outlet tubes are schematically shown shortened for illustrative purposes);

[0033] Figure 9 An automated intercostal pump-based fluid management system implanted in a patient is shown;

[0034] Figure 10A 、 Figure 10B 、 Figure 10C and Figure 10D A schematic cross-sectional view of a pump chamber having a one-way inlet valve and a one-way outlet valve and various positions or states of the one-way inlet valve and the one-way outlet valve when the pump chamber is compressed is shown;

[0035] Figure 10E and Figure 10F A schematic cross-sectional view of a pump chamber having a one-way inlet valve and a one-way outlet valve and a reinforcing member located within the pump chamber and designed to provide a greater volume change for the pump chamber under application of a given force;

[0036] Figure 11A and Figure 11B shows a perspective view of a fluid management system based on an automated intercostal pump and the relationship of the pump chamber relative to the patient's ribs during inspiration and expiration;

[0037] Figure 12 shows a schematic cross-sectional view of a one-way inlet valve in a closed state and an open state, and a schematic cross-sectional view of a one-way outlet valve in a closed state and an open state;

[0038] Figure 13 shows a perspective view of a fluid management system based on an automatic intercostal pump, comprising a pump chamber and an inlet tube having rounded and closed ends, an inlet orifice sized relative to inlet and outlet valves, and an outlet tube (the inlet and outlet tubes are schematically shown shortened for illustrative purposes);

[0039] Figure 14A shows a perspective view of an automated intercostal pump-based fluid management system including a pump chamber, an inlet tube, an outlet tube, and stabilizing and orienting features (the inlet and outlet tubes are schematically shown shortened for illustrative purposes);

[0040] Figure 14B A perspective view of an automated intercostal pump-based fluid management system with stabilization and orientation features is shown, along with the relationship of the pump chamber to the patient's ribs;

[0041] Figure 15A shows a perspective view of an automated intercostal pump-based fluid management system including a pump shaped to better accommodate the transition from the pleural space to the subcutaneous tissue and including perforated or fenestrated inlet and outlet tubes (the inlet and outlet tubes are schematically shown shortened for illustrative purposes);

[0042] Figure 15B Shown Figure 15A A schematic cross-sectional view of a pump of a fluid management system based on an automatic intercostal pump is shown in FIG;

[0043] Figure 16A shows a perspective view of an automated intercostal pump-based fluid management system including a pump shaped to better accommodate the transition from the pleural space to the subcutaneous tissue and to better prevent displacement once positioned, and including perforated or fenestrated inlet and outlet tubes (the inlet and outlet tubes are schematically shown shortened for illustrative purposes);

[0044] Figure 16B Shown Figure 16A A schematic cross-sectional view of a pump of a fluid management system based on an automatic intercostal pump is shown in FIG;

[0045] Figure 17 shows a perspective view of an alternative automatic intercostal pump-based fluid management system including a pump shaped to better accommodate the transition from the pleural space to the subcutaneous tissue and to better prevent displacement once positioned (the inlet and outlet tubes are schematically shown shortened for illustrative purposes);

[0046] Figure 18 shows a perspective view of an alternative automatic intercostal pump-based fluid management system including a pump shaped to better accommodate the transition from the pleural space to the subcutaneous tissue, to accommodate arbitrary orientation angles of the pump relative to the chest wall, and to better prevent displacement once positioned (inlet and outlet tubes are schematically shown shortened for illustrative purposes);

[0047] Figure 19 shows a perspective view of an alternative automatic intercostal pump-based fluid management system including a pump shaped to better accommodate the transition from the pleural space to the subcutaneous tissue to provide for arbitrary orientation angles of the pump relative to the chest wall, thereby providing an additional feature to secure the automatic intercostal pump-based fluid management system in place and better prevent displacement once positioned (inlet and outlet tubes are schematically shown shortened for illustrative purposes);

[0048] Figure 20A shows a perspective view of an automatic intercostal pump-based fluid management system including a pump for placement in the intercostal space and a dome-shaped diaphragm that can be manually actuated to improve the overall function of the pump system;

[0049] Figure 20B Shown Figure 20A A schematic cross-sectional view of a pump of a fluid management system based on an automatic intercostal pump is shown in FIG;

[0050] Figure 21 shows a perspective view of an automatic intercostal pump-based fluid management system including a pump for placement in the intercostal space, a dome-shaped diaphragm that can be manually actuated to improve the overall function of the pump system, and an access port having a dome-shaped septum that can be pierced to allow access to the interior of the automatic intercostal pump-based fluid management system;

[0051] Figure 22 shows a perspective view of an alternative automatic intercostal pump-based fluid management system including a pump for placement in the intercostal space, a diamond-shaped stabilizing and orienting feature, and two access ports having dome-shaped septa that can be pierced to allow access to different areas within the interior of the automatic intercostal pump-based fluid management system;

[0052] Figure 23A A perspective view of a fluid management system based on an electromechanical automatic pump using a piezoelectric diaphragm is shown;

[0053] Figure 23B 、 Figure 23C and Figure 23D Shown Figure 23A A schematic cross-sectional view of a pump of a fluid management system based on an electromechanical automatic pump as shown in FIG;

[0054] Figure 24A shows a perspective view of an automatic intercostal pump-based fluid management system including a pump for placement in the intercostal space and an electromechanical pump that can be activated to improve the overall function of the pump system;

[0055] Figure 24B Shown Figure 24A A schematic cross-sectional view of a pump of a fluid management system based on an automatic intercostal pump is shown in FIG;

[0056] Figure 25 A fluid management system based on an automated intercostal pump implanted in a patient and coupled to an external reservoir is shown;

[0057] Figure 26A and Figure 26BA method for priming fluid using an automated intercostal pump-based fluid management system is presented. DETAILED DESCRIPTION

[0058] The devices, systems, and methods described herein can be used for the purpose of draining and / or moving fluid from one cavity to another cavity in the human body. In particular, the devices, systems, and methods described herein include automatic pumps that provide general pumping functions in automatic pump-based fluid management systems.

[0059] For purposes of explanation, the disclosure herein includes discussion of the use of an automated pump-based fluid management system for the purpose of draining pleural fluid to treat pleural effusions. However, it should be understood that such application is merely one specific application of one specific embodiment of an automated pump-based fluid management system, and that other embodiments and applications are possible.

[0060] Furthermore, for purposes of explanation, the disclosure herein describes an automatic pump as being part of a particular automatic pump-based fluid management system. However, it should be understood that any such automatic pump-based fluid management system disclosed herein is merely a particular embodiment of an automatic pump-based fluid management system using an automatic pump as described herein, and that other uses of the automatic pump are possible.

[0061] Fluid management systems based on automated pumps can provide regular, continuous, and automated drainage of body fluids, thereby avoiding many of the drawbacks of other techniques for draining fluids.

[0062] 1. Fluid management system based on automatic pump

[0063] Figure 1 A perspective view of an automatic pump-based fluid management system is shown, which includes an automatic pump and includes an inlet pipe and an outlet pipe (the inlet pipe and outlet pipe are schematically shown as shortened in length for illustrative purposes). It should be understood that Figure 1 An embodiment of a fluid management system based on an automated pump is shown for purposes of explanation and other embodiments are possible.

[0064] a. Overview of Fluid Management System Based on Automatic Pump

[0065] Reference Figure 1 An automated pump-based fluid management system 100 for moving fluid from a first body compartment to a second body compartment includes a pump 110 that generally has an inlet 130 and an outlet 132 and is capable of moving fluid between the inlet 130 and the outlet 132 .

[0066] The automatic pump-based fluid management system 100 further includes a first tube 120 and a second tube 122. An inlet 130 and an outlet 132 each communicate between the interior of the pump 110 and the exterior of the pump 110 and are respectively coupled to the first tube 120 and the second tube 122. In other words, the inlet 130 and the outlet 132 are configured to provide fluid communication between the first tube 120 and the interior space of the pump 110, and between the second tube 122 and the interior space of the pump 110, respectively.

[0067] Furthermore, first tube 120 includes a tube inlet end 150 and a pump inlet end 140. Generally, first tube 120 is configured so that when using an automated pump-based fluid management system 100, tube inlet end 150 can be positioned in an area of ​​the human body from which fluid is to be drained. Pump inlet end 140, on the other hand, is coupled to inlet 130 of pump 110. Thus, as depicted by length extension 160, the length of first tube 120 can vary.

[0068] Similarly, second tube 122 includes pump outlet end 142 and tube outlet end 152. Generally, second tube 122 is configured so that when using an automatic pump-based fluid management system 100, tube outlet end 152 can be positioned in an area of ​​the human body to which fluid is to be drained. Pump outlet end 142, on the other hand, is coupled to outlet 132 of pump 110. Thus, as depicted by length extension 162, the length of second tube 122 can vary.

[0069] Although the first tube 120 and the second tube 122 are shown as entering the pump 110 in a generally straight manner (i.e., perpendicular to the wall of the pump 110), the first tube 120 and the second tube 122 can be configured to enter the pump 110 at any desired angle. For example, it may be desirable for the first tube 120 and the second tube 122 to enter and exit the pump 110 at approximately 90 degree angles, respectively, to enable the pump 110 to be positioned in a more advantageous manner. It may also be desirable for the first tube 120 and the second tube 122 to enter and exit the pump 110 at other angles.

[0070] Although tubes 120 and 122 are generally shown as flexible tubes that can be easily manipulated and / or shaped into any form or orientation, in some embodiments, it may be desirable for tubes 120 and 122 to be rigidly or semi-rigidly defined to some extent so that the desired shape or orientation of the tubes can be maintained. For example, one of the tubes may be at least partially rigidly or semi-rigidly constructed, shaped, or cast so that the tube has a 90-degree bend when exiting the intercostal pump 110. Each of tubes 120 and 122 may be constructed with a similar 90-degree bend. Alternatively, the tubes may not have similar bends. As yet another alternative, the tubes may each have some other degree of bend.

[0071] To achieve fluid movement based on an automatic pump, the pump 110 can be an automatic intercostal pump, as discussed in more detail below, which includes a generally elastic, flexible chamber with a one-way valve at the inlet and a one-way valve at the outlet, and the pump 110 utilizes the rib movement during normal breathing to automatically and cyclically compress and decompress the elastic, flexible chamber between adjacent ribs and thereby provide a pumping action. Alternatively, as will be discussed in more detail below, the pump 110 can be an electromechanical pump, such as a gear pump, a screw pump, a rotary vane pump, a diaphragm pump, a piezoelectric diaphragm pump, a plunger pump, a peristaltic pump, a cam pump, a piston pump, or a centrifugal pump. Other types of pumps are also possible.

[0072] b. Fluid management system based on pleural and peritoneal automatic pump

[0073] Reference Figure 2A , an automatic pump-based fluid management system 100 is shown implanted in a patient 200 and provides for draining fluid from a first region 220 to a second region 230 within the patient's body. In one embodiment, as in Figure 2A In the embodiment depicted in , fluid is drained from the patient's pleural cavity to the patient's peritoneal cavity. Thus, in such an embodiment, the first region 220 is the patient's pleural cavity and the second region 230 is the patient's peritoneal cavity.

[0074] In an embodiment, the automatic pump 110 is configured so that it can be placed under the patient's skin, on the exterior of the patient's chest cavity 400. To access the patient's pleural cavity 220, a first tube 120 is passed from the pump inlet 130 and across the chest cavity 400 between adjacent ribs, wherein the tube inlet end 150 of the first tube 120 is disposed in the person's pleural cavity 220, from which fluid will be drained. A second tube 122 is passed from the pump outlet 132 and across the abdominal wall under the skin, wherein the tube outlet end 152 of the second tube 122 is disposed in the person's peritoneal cavity 230, into which fluid will be drained. The peritoneal cavity 230 has a fluid absorption capacity, such that excess fluid transferred from the pleural cavity 220 will be absorbed into, for example, the patient's interstitial tissue, lymphatic vessels, and blood vessels, thereby minimizing the accumulation of fluid in the peritoneal cavity 230.

[0075] In other embodiments, Figure 2BAs shown in FIG, the automatic pump 110 can be configured so that the automatic pump 110 can be placed in the patient's pleural cavity 220. The tube inlet end 150 of the first tube 120 and the first tube 120 can be placed in the patient's pleural cavity 220, and the fluid will be drained from the pleural cavity 220. The second tube 122 leads from the pump outlet 132 of the automatic pump 110 located in the pleural cavity 120 into the peritoneal cavity, so that the tube outlet end 152 of the second tube 122 is placed in the patient's peritoneal cavity 230, and the fluid will be drained into the peritoneal cavity 230. The second tube 122 can traverse the thoracic cavity 400 between adjacent ribs, run along the thoracic cavity 400 under the skin, and traverse the abdominal wall, so that the tube outlet end 152 of the second tube 122 is placed in the patient's peritoneal cavity 230, and the fluid will be drained into the peritoneal cavity 230. Alternatively, the second tube 122 may be routed directly from the patient's pleural cavity 220 through the diaphragm 240 and into the patient's peritoneal cavity 230 .

[0076] In other embodiments, Figure 2C As shown in FIG, the automatic pump 110 and the outlet second tube 230 can be configured to be placed in the patient's peritoneal cavity 230, wherein the first tube is passed from the pump inlet 130 through the abdominal wall along the chest cavity 400 under the skin, and traverses the chest cavity 400 between adjacent ribs to enter the pleural cavity 220, so that the tube inlet end 150 of the first tube 120 is located in the pleural cavity. Alternatively, the path of the first tube 120 can be directly from the patient's pleural cavity 220 through the diaphragm 240 to the patient's peritoneal cavity 230.

[0077] c. Pleural and peritoneal pressures

[0078] The pressure in the pleural cavity 220 and the pressure in the peritoneal cavity 230 are different, not static, and generally vary during normal breathing. Inspiration is an active process requiring muscle contraction. During inspiration, the external intercostal muscles contract, causing the ribs and sternum to elevate, and the diaphragm contracts, flattens, and presses against the abdominal contents. This combined action results in expansion of the thoracic cavity, with pleural pressure (P) that causes the elastic lung to expand. 胸膜 ) decreases and simultaneously causes compression of abdominal contents, accompanied by peritoneal pressure (P 腹膜 ) increases. Exhalation during normal breathing is largely a passive process that relies on elastic recoil. During exhalation, the external intercostal muscles and the diaphragm simply relax. As the external intercostal muscles relax, the elasticity of the inflated lungs causes the external intercostal muscles to retract to their original position. At the same time, the diaphragm relaxes, and the compressed abdominal contents push the diaphragm upward. This combined action results in a decrease in the size of the chest cavity, with an associated pleural pressure (P 胸膜 ) increased, and at the same time peritoneal pressure (P 腹膜 )reduce.

[0079] like Figure 3As seen in the literature, during normal resting respiration in patients with little or no pleural effusion, pleural pressure (P 胸膜 ) varies from approximately +3 cmH2O at the end of expiration to approximately -2 cmH2O at the end of inspiration, and the peritoneal pressure (P 腹膜 ) varies from about +5 cmH2O at end-expiration to about +13 cmH2O at end-inspiration. Throughout the respiratory cycle, overall pleural pressure is lower than peritoneal pressure, with the gradient varying, on average, from about -2 cmH2O at end-expiration to about -15 cmH2O at end-inspiration. [Miller JD, Skeletal muscle pump versus respiratory muscle pump: modulation of venous return from the locomotor limb in humans. J Physiol. 2005;563(3):925-943]. Pleural pressure, peritoneal pressure, and the pleural-to-peritoneal pressure gradient vary from patient to patient and with exertion, coughing, sneezing, deep breathing, body position, chest or abdominal disease, previous chest or abdominal surgery, and the presence of pleural effusion. In fact, the presence of pleural effusion can add a significant hydrostatic component to the pleural space pressure, thus changing the pleural pressure from low or even negative to positive values. In fact, in patients with pleural effusion, the pleural pressure (P 胸膜 ) can rise to about +10 cmH2O to about +15 cmH2O, and when the exudate is drained, the pleural pressure (P 胸膜 ) can decrease to about -10 cmH2O to about -15 cmH2O. [Feller-Kopman D. Large-volume thoracentesis and the risk of re-expansion pulmonary edema. Ann Thor Surg. 2007;84:1656-1662]. When the effects of pleural effusion are added to the changes that occur during normal breathing, pleural pressure can be higher than peritoneal pressure during the respiratory cycle, with the gradient ranging from about -5 cmH2O to about +13 cmH2O when effusion is present.

[0080] For the automated pump-based fluid management system 100 to transfer fluid from the pleural cavity 220 to the peritoneal cavity 230, the automated pump 110 can overcome the pressure gradient that exists from the pleural cavity 220 to the peritoneal cavity 230. As described above, this pressure gradient changes during the respiratory cycle and in the presence of pleural effusions and transudates. When the automated pump-based fluid management system 100 is initially installed and transudates are present in the pleural cavity 220, fluid can flow freely between the pleural cavity 220 and the peritoneal cavity 230 when the combined opening pressure of the valves within the automated pump 110 is lower than the pleural and peritoneal pressure gradient.

[0081] like Figure 3 As shown in , when the pleural effusion is mostly drained from the pleural cavity 220, there is a low pleural-peritoneal pressure gradient. Due to this pressure gradient, at the end of expiration, the automatic pump 110 can generate a discharge pressure of at least about 2 cmH2O to overcome the pressure gradient and pump fluid from the pleural cavity 220 to the peritoneal cavity 230. Similarly, at the end of inspiration, the automatic pump 110 can generate a discharge pressure of at least about 15 cmH2O to overcome the pressure gradient between the peritoneal cavity 230 and the pleural cavity 220, and thus be able to pump fluid from the pleural cavity 220 to the peritoneal cavity 230. It is noted that if the pump generates a constant discharge pressure, the flow rate between the pleural cavity 220 and the peritoneal cavity 230 will vary during the respiratory cycle due to the changing pressure gradient between the peritoneal cavity 230 and the pleural cavity 220. The above values ​​are based on average observations. In some cases, the pump can generate a discharge pressure of at least about 25 cmH2O to overcome the variations in pressure gradients that may exist during a complete cycle of normal breathing and, therefore, be able to pump fluid from the pleural and peritoneal cavities 220, 230 at any point during normal breathing, and the pump can even generate a discharge pressure of up to about 35 cmH2O to about 50 cmH2O to overcome inter-patient variability. Additionally, it can be noted that the automatic pump 110 can be designed to operate preferentially during exhalation and ideally operate during the final portion of exhalation when the pressure gradient between the peritoneal and pleural cavities 230 is lower. In such cases, the automatic pump 110 may only need to generate a minimum discharge pressure of about 5 cmH2O, or preferably about 10 cmH2O to about 15 cmH2O, to overcome inter-patient variability and to pump fluid from the pleural and peritoneal cavities 220, 230. This lower discharge pressure translates into a lower rate of power consumption and lower total work per unit volume of exudate pumped by the automatic pump 110 when compared to operation of the automatic pump 110 during the entire respiratory cycle, the beginning portion of exhalation, or the end portion of inspiration.

[0082] d. Pleural fluid fragments and coagulation proteins

[0083] In both health and disease, pleural fluid is essentially a filtrate of blood modified by reabsorption. Filtration occurs through the vessel walls, interstitial tissue, and mesothelial cell membranes lining the visceral and parietal pleura, and modification occurs through reabsorption of fluids, solutes, proteins, and cells. Similar to the interstitial fluid of other organs, in healthy individuals, pleural fluid contains protein and a small number of cells. Pleural fluid proteins have a total concentration of approximately 1.0 g / dl (compared to plasma total protein concentrations of 6.0 g / dl or more), with albumin being the highest, accounting for approximately 50% of the total protein, globulins being the second highest, accounting for approximately 35% of the total protein, and fibrinogen being the third highest, accounting for less than 20% of the protein. The cell concentration is approximately 2,000 cells / mm 3 The volume of pleural fluid is mainly composed of mesothelial cells, monocytes and lymphocytes.

[0084] In malignant tumors, this filtration and reabsorption system is unbalanced. The cells, membranes, and tissues used to filter the blood tend to be less selective, and the reabsorption mechanisms are altered and often less efficient. As a result, malignant tumors produce pleural fluid with increased volume and abnormal composition, resulting in a fluid rich in proteins and cells, as well as different types of proteins and cells present. In fact, the total protein concentration of pleural fluid is often greater than 2.9 g / dL, and the cell concentration may be many-fold increased.

[0085] Fibrinogen is an important protein in pleural fluid. Fibrinogen is converted to fibrin by thrombin in a process called fibrinolysis. Fibrin is broken down by the action of plasminogen in a process called fibrinolysis. Plasminogen is in turn activated by tissue plasminogen activator (tPA), which is inhibited by plasminogen activator inhibitor-1 (PAI-1). The net amount of fibrin produced is the result of an imbalance between fibrinolysis and fibrinolysis.

[0086] Pleural fluid fibrinogen concentrations are typically low relative to plasma concentrations. Even in patients with malignant tumors, when total protein concentrations tend to increase, pleural fluid fibrinogen concentrations tend to be even lower, pleural fluid tPA levels tend to increase, and PAI-1 tends to decrease. All of these tend to reduce net fibrin production.

[0087] Despite this, an imbalance between fibrinogenesis and fibrinolysis may occur in patients with malignant pleural effusions and may lead to the formation of fibrin. Fibrin can organize into small clots, strands, membranes, and septa. Fibrin membranes and septa are responsible for the formation of cavities or pockets in the pleural fluid, which can make drainage of fluid from the pleural space difficult, and fibrin clots and strands can obstruct drainage tubes.

[0088] Indeed, the gross anatomy of malignant pleural effusions as demonstrated by transthoracic ultrasound of the pleural cavity revealed complex septate effusions in 8.7% of patients, homogeneously echogenic effusions in 15.4%, and complex nonseptate effusions in 65.4%, both of which likely represent some combination of blood and cells and fibrin debris, with only 10.6% of patients presenting with anechoic (clear fluid).

[0089] To prevent blockage or clogging of an automated pump-based fluid management system and maintain flow through the system, a number of strategies may be employed, either alone or in combination. One strategy is to provide multiple fluid inlet paths. Figure 4 , the first tube 120 may include one or more fluid inlet perforations 170. The fluid inlet perforations 170 may take the form of holes in the wall of the first tube 120, allowing fluid to be drawn into the first tube 120 not only through the tube inlet end 150 but also through the fluid inlet perforations 170. The fluid inlet perforations 170 may avoid obstruction of flow into the first tube 120 or may increase the volume or efficiency of fluid drawn into the first tube 120, and thus, may increase the volume or efficiency of fluid drained by the automated pump-based fluid management system 101. The fluid inlet perforations 170 may also be advantageous by allowing for alternative fluid inlet locations in the event that the tube inlet end 150 or other perforations 170 become obstructed, for example, due to a fibrin clot, fibrin strands, or other debris, or if the first tube 120 abuts against the chest wall or lungs. The second tube 122 may also include a fluid outlet perforation 180.

[0090] An additional or alternative strategy is to configure the first tube 120 to provide a filtering mechanism for fluid entering an automated pump-based fluid management system. Figure 5 , the first tube 120 may include one or more filtered fluid inlet perforations 173. The filtered fluid inlet perforations 173 may take the form of holes in the wall of the first tube 120 that allow fluid to be drawn into the first tube 120. The filtered fluid inlet perforations 173 are sized and shaped such that any fibrin clots, fibrin strands, or other debris that are able to pass through the filtered fluid inlet perforations 173 can pass through the entire fluid path of the filtered automatic pump-based fluid management system 102 without blocking or significantly impeding fluid flow. Alternatively, the filtered fluid inlet perforations 173 are sized and shaped such that each such perforation is smaller than the smallest opening that exists along the entire fluid path of the filtered automatic pump-based fluid management system 102. Therefore, any fibrin clots, fibrin strands, or other debris that may pass through the filtered fluid inlet perforations 173 will be smaller than the smallest opening in the fluid path of the filtered automatic pump-based fluid management system 102, and therefore should be able to pass through the fluid path of the filtered automatic pump-based fluid management system 102. Figure 5As illustrated in , the tube inlet end 150 of the first tube 120 may include a closed end, and in some cases may be rounded or smooth to aid in placement of the first tube 120 .

[0091] like Figure 6 As shown in FIG, in another additional or alternative potential strategy, a fibrinolytic coating 190 is provided on at least a portion of the first tube 120 that is exposed to the pleural fluid. Such a fibrinolytic coating 190 can be used to break down fibrin, fibrin clots, fibrin strands, fibrin films, fibrin septa, and any other fibrin fragments in the fluid, which will allow the fluid to pass through the filter-based automatic pump-based fluid management system 102. Examples of fibrinolytic factors for use with the fibrinolytic coating 190 include plasmin, tissue plasminogen activator, urokinase, streptokinase, plasminogen activator inhibitor-1 inhibitor, and plasminogen activator inhibitor-2 inhibitor. Other examples of fibrinolytic agents can be used.

[0092] In another additional or alternative strategy, e.g. Figure 7 As shown in FIG, a fibrin remover 192 is disposed on at least a portion of the first tube 120 that is exposed to the pleural fluid. The fibrin remover is designed to convert fibrinogen into fibrin and to bind the fibrin to the tip of the catheter, so that the fibrin is no longer free in the pleural fluid to enter the fluid path of the automatic pump-based fluid management system 102. Examples of fibrin removers include thrombin, factor XIIIa, surface roughness, surface texture, microfibers, and polyester. Other fibrin removers or other methods of converting fibrinogen into fibrin can also be used to remove fibrin from the pleural fluid, so that the fibrin is no longer free in the pleural fluid to block the fluid path of the automatic pump-based fluid management system 102.

[0093] In an additional or alternative strategy to prevent clogging, the fluid inlet, fluid outlet, first tube, second tube, or any other aspect of the automated pump-based fluid management system can be coated with an anticoagulant or fibrinolytic factor. For example, a component or surface of the pump 110, first tube 120, or second tube 122 can be at least partially coated with an anticoagulant or fibrinolytic factor. The presence of the anticoagulant can reduce the amount of clots that would otherwise form if the anticoagulant were not present. Examples of anticoagulants include heparin, low molecular weight heparin, fondaparinux, edaparinux, biotinylated edaparinux, dabigatran, rivaroxaban, apixaban, betrixaban, edoxaban, darixaban, levoxaban, elixaban, hirudin, lepirudin, bivalirudin, argatroban, dabigatran, ximelagatran, hibiscus, vitamin E, coumarin, warfarin, acenocoumarol, phenprocoumon, atomycin, phenindione, brodifacoum and bifenthrin. Examples of fibrinolytic factors include plasmin, tissue plasminogen activator, urokinase, streptokinase, plasminogen activator inhibitor-1 inhibitor and plasminogen activator inhibitor-2 inhibitor. Other examples of anticoagulants or fibrinolytic agents can be used.

[0094] In another additional or alternative potential strategy, to prevent blockages or to address blockages if they occur, the walls of the automated pump 110 may be constructed of a material that can be pierced with a needle or similar object to instill, for example, an anticoagulant, fibrinolytic, or other suitable material into the interior of the automated pump-based fluid management system 100. Alternatively, and as described further below, an access port may be added to the automated pump 110, which would also allow, for example, an anticoagulant, fibrinolytic, or other suitable material to be instilled into the interior of the automated pump-based fluid management system 100.

[0095] In an additional or alternative strategy to prevent occlusion, patients may be selected based on favorable pleural effusion characteristics as demonstrated by transthoracic ultrasound of the pleural cavity 220 that are less likely to occlude the system.

[0096] For example, the use of an automated pump-based fluid management system may be limited to patients with anechoic (clear fluid) as demonstrated by transthoracic ultrasound of the pleural cavity 220. Other pleural effusion characteristics, such as complex septated effusions, homogeneously echogenic effusions, complex non-septated effusions, or a combination of characteristics, may also be advantageous.

[0097] 2. Fluid management system based on automatic intercostal pump

[0098] Reference Figure 8AAn automatic intercostal pump-based fluid management system 103 for placement between a first rib and a second rib includes a pump 111, which is typically a resilient, flexible structure enclosing an interior space and having an inlet 130 and an outlet 132. The automatic intercostal pump 111 can be made of any suitable material that allows the pump 111 to be compressed and then freely return to its original state. For example, the pump 111 can be a resilient, flexible tube or cylindrical member made of polyurethane, silicone, polyvinyl chloride, or latex rubber. Alternatively, the pump 111 can be made of a combination of two or more materials, wherein at least one of the components provides elasticity and at least one of the components provides fluid containment. For example, the pump 111 can include an elastic nickel-titanium alloy, steel, polyester, or other elastic component to provide elasticity, and a second fluid containment component, such as polyurethane, silicone, polyvinyl chloride, latex rubber, polyethylene terephthalate, nylon, polytetrafluoroethylene, polyetheramide, etc., to provide fluid containment within the pump 111.

[0099] Although the pump 111 is generally shown as cylindrical, other configurations are possible. In short, the pump 111 can be any shape that provides suitable compression / decompression and is positioned in the intercostal area. In particular, it may be desirable to conform the pump 111 to the characteristics (i.e., shape and / or space) of a particular area to some extent. In embodiments, the pump 111 can include a flexible silicone tube. However, the pump 111 can also take other forms.

[0100] The automatic intercostal pump-based fluid management system 103 further includes a first tube 120 and a second tube 122. An inlet 130 and an outlet 132 each communicate between the interior and exterior of the intercostal pump 111 and are coupled to the first tube 120 and the second tube 122, respectively. In other words, the inlet 130 and the outlet 132 are configured to provide fluid communication between the first tube 120 and the interior space of the intercostal pump 111, and between the second tube 122 and the interior space of the intercostal pump 111, respectively.

[0101] First tube 120 includes a tube inlet end 150 and a pump inlet end 140. Generally, first tube 120 is configured so that when using an automated intercostal pump-based fluid management system 103, tube inlet end 150 can be positioned in an area of ​​the human body from which fluid is to be drained. Pump inlet end 140, on the other hand, is coupled to inlet 130 of intercostal pump 111. Thus, as depicted by length extension 160, the length of first tube 120 can vary.

[0102] Similarly, second tube 122 includes a pump outlet end 142 and a tube outlet end 152. Generally, second tube 122 is configured so that tube outlet end 152 can be positioned in an area of ​​the human body where fluid is drained when using an automated intercostal pump-based fluid management system 103. Pump outlet end 142, on the other hand, is coupled to outlet 132 of intercostal pump 111. Thus, as depicted by length extension 162, the length of second tube 122 can vary.

[0103] Although the first tube 120 and the second tube 122 are shown as entering the intercostal pump 111 in a generally straight manner (i.e., perpendicular to the wall of the pump 111), the first tube 120 and the second tube 122 can be configured to enter the intercostal pump 111 at any desired angle. For example, it may be desirable for the first tube 120 and the second tube 122 to enter and exit the intercostal pump 111 at approximately 90-degree angles, respectively, to enable the intercostal pump 111 to be more advantageously positioned in the intercostal region. It may also be desirable for the first tube 120 and the second tube 122 to enter and exit the intercostal pump 111 at other angles.

[0104] Although tubes 120 and 122 are generally shown as flexible tubes that can be easily manipulated and / or shaped into any form or orientation, in some embodiments, it may be desirable for tubes 120 and 122 to be rigidly or semi-rigidly defined to some extent so that the desired shape or orientation of the tubes can be maintained. For example, one of the tubes may be at least partially rigidly or semi-rigidly constructed, shaped, or cast so that the tube has a 90-degree bend when it exits intercostal pump 111. Each of tubes 120 and 122 may be constructed with a similar 90-degree bend. Alternatively, the tubes may not have similar bends. As yet another alternative, the tubes may each have some other degree of bend.

[0105] Reference Figure 8A First tube 120 may include one or more fluid inlet perforations 170. Fluid inlet perforations 170 may take the form of holes in the surface of first tube 120 to allow fluid to be drawn into first tube 120 not only through tube inlet end 150, but also through fluid inlet perforations 170. Fluid inlet perforations 170 may increase the volume or efficiency of fluid drawn into first tube 120 and, therefore, the volume or efficiency of fluid drained by intercostal pump-based fluid management system 103. Fluid inlet perforations 170 may be particularly advantageous in situations where tube inlet end 150 or other perforations become obstructed due to, for example, a fibrin clot, fibrin strands, or other debris, or where first tube 120 is abutted against the chest wall or lung, as they allow for alternative fluid inlet locations. Second tube 122 may also include fluid outlet perforations 180.

[0106] Reference Figure 8BAs shown in the inset cross-section C illustrated therein, the first tube 120 can include one or more linear fluid channels 175. Linear fluid inlet slits 174 in the surface of the first tube 120 open into the linear fluid channels 175, thereby allowing fluid to be drawn into the linear fluid channels 175 of the first tube 120. Combined, these features provide redundancy to prevent clogging of the first tube 120. The linear fluid inlet slits 174 can be particularly advantageous by allowing nearly continuous access to the interior of the first tube 120 along a majority of its length. This allows the first tube 120 as a whole to still allow fluid to enter the interior of the first tube 120 and along its length if a single slit or a portion of the slits become blocked, for example, due to a fibrin clot, fibrin strands, or other debris, or if the first tube 120 abuts the chest wall or lungs. Furthermore, the linear fluid inlet slits 174 can be sized to limit the size of particles or debris that enter the linear fluid channels 175. The size may be selected to prevent the ingress of particles or debris large enough to block the lumen of the linear fluid channel 175 or any other stenoses within the automated intercostal pump based fluid management system 103 .

[0107] about Figure 8A and Figure 8B The described automatic intercostal pump based fluid management system 103 may additionally or alternatively include Figures 4 to 7 any other features, materials, or characteristics described in connection with the automatic pump-based fluid management system.

[0108] 3. Pleural and peritoneal fluid management system based on intercostal pump

[0109] Reference Figure 9 , a fluid management system 103 based on an automatic intercostal pump is shown as being implanted in a patient 200 and provides for draining fluid from a first region 220 to a second region 230 within the patient's body. In one embodiment, as in Figure 9 In the embodiment depicted in , fluid is drained from the patient's pleural cavity to the patient's peritoneal cavity. Thus, in such an embodiment, the first region 220 is the patient's pleural cavity and the second region 230 is the patient's peritoneal cavity.

[0110] In embodiments, the automatic intercostal pump 111 is configured such that it can be at least partially positioned within the intercostal region between two ribs. In other words, when implanted, the intercostal pump 111 extends through the patient's intercostal space, or at least a portion of the intercostal space. Thus, the first tube 120 and the corresponding pump inlet 130 are positioned on the interior of the patient's thorax. The second tube 122 and the corresponding pump outlet 132 are positioned on the exterior of the patient's thorax. Thus, upon breathing and corresponding compression / decompression of the thorax, the patient 210 automatically causes the intercostal pump 111 (e.g., "the pump") to operate. The operation of the intercostal pump 111 is discussed further below.

[0111] 4. Automatic intercostal pump

[0112] a. Automatic intercostal pump design

[0113] Figure 10A A schematic cross-sectional view of the automatic intercostal pump 111 is shown in a generally or substantially uncompressed state, with both the one-way inlet valve 320 and the one-way outlet valve 322 (described in further detail below) closed. As described above, the automatic intercostal pump 111 can typically be a resilient, flexible tube or cylindrical member made of polyurethane, silicone, polyvinyl chloride, latex rubber, or other suitably resilient material. Alternatively, the pump 111 can be made of a combination of two or more materials, wherein at least one of the materials provides resiliency and at least one of the components provides fluid containment. For example, the pump 111 can include a first resilient component such as a resilient nickel-titanium alloy, steel, polyester, or other resilient component, and a second fluid containment component such as polyurethane, silicone, polyvinyl chloride, latex rubber, polyethylene terephthalate, nylon, polytetrafluoroethylene, polyetheramide, etc., to minimize leakage from within the intercostal pump 111. Other materials may also be used.

[0114] The automatic intercostal pump 111 includes a pump wall that encloses an interior space 330. For purposes of explanation, the pump wall is depicted as including an upper wall 310 and a lower wall 312. This distinction between the upper and lower walls is made for the purpose of clearly explaining the compression / decompression of the intercostal pump 111 and should not be construed as limiting the intercostal pump 111 to including two distinct pump walls.

[0115] In general, the pump wall 310 (312) can be constructed of any material and any thickness suitable for achieving the desired flexibility and resiliency of the intercostal pump 111. The specific thickness of the pump wall 310 (312) in a given embodiment can depend on, for example, the material of the pump wall 310 (312) and the intended use of the intercostal pump 111 (e.g., drainage function). In some embodiments, the pump wall 310 (312) can be made of silicone, wherein the hardness of the ASTM D2240 Type A durometer is between about 30 and about 70 (Young's modulus is between about 1.15 MPa and about 5.5 MPa), preferably between about 40 and about 60 (Young's modulus is between about 1.7 MPa and about 3.6 MPa), and more preferably between about 45 and about 50 (Young's modulus is between about 2.0 MPa and about 2.5 MPa). In some embodiments, the intercostal pump 111 can include a generally or generally cylindrical silicone structure having a generally circular cross-section. The generally cylindrical silicone structure may have an inner diameter between about 2 mm and about 14 mm, preferably between about 4 mm and about 10 mm, and more preferably between about 6 mm and about 7 mm; an outer diameter between about 3 mm and about 16 mm, preferably between about 6 mm and about 12 mm, and more preferably between about 8 mm and about 10 mm; and a wall thickness of about 0.3 mm to about 3 mm, preferably between about 0.5 mm and about 2 mm, and more preferably between about 0.7 mm and about 1.0 mm. In an embodiment, the generally cylindrical structure may have an inner diameter of about 6.4 mm and an outer diameter of about 8 mm, with a corresponding wall thickness of about 0.8 mm. In other embodiments, the intercostal pump 111 may include a silicone structure having a generally elliptical cross-section or a generally rectangular cross-section. Other shapes and sizes may also be desired.

[0116] The intercostal pump 111 also includes a one-way inlet valve 320 and a one-way outlet valve 322. The inlet valve 320 can be located in the interior space 330 of the pump body, generally proximate the inlet 130. The one-way inlet valve 320 can be any suitable one-way valve and can be made, for example, from silicone or other suitable materials. The one-way inlet valve 320 is configured to prevent or substantially prevent fluid from moving from the interior space 330 of the intercostal pump 111 to the inlet 130. At the same time, the one-way inlet valve 320 is configured to allow fluid to move from the inlet 130 to the interior space 330 of the intercostal pump 111. In other words, the one-way inlet valve 320 is in fluid communication with the inlet 130 to generally provide one-way fluid movement from the inlet 130 to the interior space 330 of the intercostal pump 110.

[0117] Correspondingly, a one-way outlet valve 322 can be located within the interior space 330 of the pump body, generally proximate the outlet 132. The one-way outlet valve 322 can be any suitable one-way valve and can be made, for example, from silicone or other suitable materials. The one-way outlet valve 322 is configured to allow fluid to move from the interior space 330 of the intercostal pump 111 to the outlet 132. At the same time, the one-way outlet valve 322 is configured to prevent or substantially prevent fluid from moving from the outlet 132 to the interior space 330 of the intercostal pump 111. In other words, the one-way outlet valve 322 is in fluid communication with the outlet 132 to provide one-way fluid movement from the interior space 330 of the intercostal pump 111 to the outlet 132.

[0118] In an embodiment of the intercostal pump 111, a one-way inlet valve frame 340 and a one-way outlet valve frame 342 are added to the outer periphery of the one-way inlet valve 320 and the outer periphery of the one-way outlet valve 322, respectively, so that compression / decompression of the intercostal pump 111 does not cause significant compression, deformation, or undesirable wear of the one-way inlet valve 320 and the one-way outlet valve 322. The one-way inlet valve frame 340 and the one-way outlet valve frame 342 can each be constructed of any relatively rigid or non-flexible material suitable for the outer periphery of the one-way inlet valve 320 and the outer periphery of the one-way outlet valve 322, respectively. Furthermore, the size and shape of each of the one-way inlet valve frame 340 and the one-way outlet valve frame 342 can be selected to provide a joint or interconnectable joint between the first tube 120 and the upper wall 310 and lower wall 312 of the intercostal pump 111, and between the second tube 122 and the upper wall 310 and lower wall 312 of the intercostal pump 111. Other types of valve frames may be used that can function such that compression / decompression of the intercostal pump 111 does not result in significant compression, deformation, or undesirable wear of the one-way inlet valve 320 and the one-way outlet valve 322 .

[0119] Note that although the one-way inlet valve 320 and the one-way outlet valve 322 are depicted as being located within the interior space 330 of the intercostal pump 111, alternative valve placements may also be desirable. For example, one or both of the one-way inlet valve 320 and the one-way outlet valve 322 may be located external to the pump body, within the inlet pipe 120 and the outlet pipe 122, respectively, or between the inlet pipe 120 and the pump body or between the outlet pipe 122 and the pump body, respectively. The specific placement of the valves is not necessarily critical, so long as the valves provide sufficient one-way fluid flow into and out of the intercostal pump 111.

[0120] b. Pump operation

[0121] Figure 10BA schematic cross-sectional view of the intercostal pump 111 is shown in a generally or substantially compressed state. As shown, in embodiments, a first force 350 may act on the upper wall 310, causing the upper wall 310 to collapse toward the interior space 330. Correspondingly, a second force 352 may additionally or alternatively act on the lower wall 312, causing the lower wall 312 to collapse toward the interior space 330. The collapse of the upper wall 310 and / or the lower wall 312 serves to reduce the volume of the interior space 330 and increase the pressure within the interior space 330. This increase in pressure causes the one-way inlet valve 320 to remain closed and the one-way outlet valve 322 to open, and fluid within the interior space 330 flows from the interior space 330, through the one-way outlet valve 322, and into the second tube 122. For an incompressible fluid, the change in volume experienced by the interior space in response to the collapse of the upper wall 310 and / or the lower wall 312 will be approximately equal to the volume of fluid moved from the interior space 330 through the one-way outlet valve 322. As the fluid moves from the interior space 330 through the one-way outlet valve 322, the pressure in the interior space will decrease. Figure 10C As shown in FIG, once the internal pressure is about equal to or substantially equal to the pressure in the pump outlet 132, the flow will stop and the one-way outlet valve 322 will close.

[0122] As mentioned above, the intercostal pump 111 is generally elastically flexible and therefore, in Figure 10B and Figure 10C After being placed in the compressed state as shown in FIG, when at least one of the first force 350 and the second force 352 is removed, the intercostal pump 111 will return to the state shown in FIG. Figure 10D . When the first force 350 is removed, the upper wall 310 returns to its uncompressed state, and / or when the second force 352 is removed, the lower wall 312 returns to its uncompressed state, the volume of the interior space 330 increases, and the pressure in the interior space 330 decreases. The pressure inside the interior space 330 eventually drops below the pressure inside the inlet, causing the one-way inlet valve 320 to open and fluid located in the inlet to flow into the interior space 330. In this manner, the intercostal pump 111 operates as a pump that generally draws fluid from the pump inlet 130 and delivers the fluid to the pump outlet 132.

[0123] In addition, if Figure 10E and Figure 10F As shown in FIG, the intercostal pump 111 can be configured with a reinforcing member 333 incorporated into or attached to the wall so that when at least one of a first force 350 and a second force 352 is applied, the intercostal pump 111 is Figure 10A and Figure 10B333. As shown in FIG. 33, a larger volume change can be generated in the interior space 330 than the volume change in the interior space 330 shown in FIG. 33 when the reinforcement member 333 is absent. This occurs because the reinforcement member 333 is used to distribute the applied first force 350 and second force 352 relatively narrowly along a greater length of the upper and lower walls 310, 312 of the pump, thereby resulting in a larger change in the pump's interior volume 330. Although the reinforcement member 333 is shown as being located midway along the length of the upper and lower walls 310, 312, such that both ends of the reinforcement member 333 move together, the reinforcement member 333 can also be positioned such that one end of each member is positioned very close to or even attached to the one-way inlet valve frame 340 or the one-way outlet valve frame 342, such that the reinforcement member now acts as a lever arm, providing an even larger volume change to the interior space 330 when at least one of the first force 350 and second force 352 is applied. Reinforcement member 333 may generally be any suitable size and shape and may be made from any suitable material, and in some cases may be made from any suitable material that is generally more rigid than the material forming upper wall 310 and lower wall 312 .

[0124] In use, the intercostal pump 111 may be compressed by the patient's breathing. More specifically, the intercostal pump 111 may be compressed by the natural movement of the patient's ribs during the breathing cycle. Furthermore, the intercostal pump 111 may be positioned so that the interior space 330 passes between fibers of the external intercostal muscles or the internal intercostal muscles and may be compressed by contraction of these muscle fibers.

[0125] like Figure 11A As shown in FIG, in use, the intercostal pump 111 is positioned between a first rib 412 and a second rib 414 selected from the ribs in the chest wall. The first and second ribs mentioned herein do not necessarily refer to the anatomical first and second ribs, but can be the anatomical first and second ribs. When the chest cavity expands (during inspiration), the individual ribs 410, 412, 414, and 416 move apart, and in this configuration of the ribs, relatively little force is exerted on the intercostal pump 111. Thus, the intercostal pump 111 is in a generally or substantially uncompressed state.

[0126] like Figure 11B As shown in FIG, when the thorax contracts (during exhalation), the various ribs 410, 412, 414, and 416 move toward each other. As a result, the first force 350 and / or the second force 352 are exerted on the intercostal pump 110 through the first rib 412 and / or the second rib 414, respectively. As a result, the intercostal pump 111 is in a generally or substantially compressed state.

[0127] The average adult breathes about 16 times per minute. Therefore, in use, the intercostal pump 111 can be compressed approximately 16 times per minute, or 23,040 times per day. Of course, this is only an approximation and can vary greatly. Although the rate at which fluid is pumped will vary with the compression rate and the amplitude of the compression (i.e., the degree of rib movement), the specific compression rate is not necessarily critical to the function of the intercostal pump 111.

[0128] The average adult exhibits approximately 0.25 mm to 3 mm of relative motion between the first rib 412 and the second rib 414 throughout a respiratory cycle. Thus, the walls of the intercostal pump 111 may be compressed approximately 0.25 mm to 3 mm during each breath. Of course, this is only an approximation and may vary from patient to patient, and for any given patient, may vary depending on the specific anatomy of the first and second ribs 412, 414 and their specific location along the length of the first and second ribs 412, 414 relative to the spine and / or sternum.

[0129] A related consideration is that the ribs are filled with soft tissue. Soft tissue itself can be compressible, and therefore, if any soft tissue is left in position between the intercostal pump 111 and either the first rib 412 or the second rib 414, the full extent of compression possible with the intercostal pump 111 may be compromised. Therefore, in some cases, it may be desirable to remove the soft tissue at the point of contact between the intercostal pump 111 and either the first rib 412 or the second rib 414.

[0130] Another related consideration is that ribs typically exhibit relatively cartilaginous portions, which themselves can be relatively compressible. Thus, in some cases, it may be desirable to position intercostal pump 111 so as to contact portions of first rib 412 and second rib 414 that exhibit a relatively small amount of cartilage (i.e., a portion of the rib that has a relatively large amount of exposed bone as opposed to cartilage).

[0131] Yet another related consideration is that it may be desirable to position the intercostal pump 111 in such a manner that the amount of surface area of ​​the intercostal pump 111 in contact with each of the first rib 412 and the second rib 414 is significantly increased or substantially maximized. In this manner, the intercostal pump 111 can withstand a greater amount of compression. Thus, it may be desirable to position the intercostal pump 111 generally parallel to the first rib 412 and the second rib 414, or in a manner such that the intercostal pump 111 is substantially parallel to the first rib 412 and the second rib 414. Figure 11A and Figure 11B The first and second ribs 412, 414 may be positioned at any angle between approximately perpendicular to the first and second ribs 412, 414, as opposed to generally being indicated as being substantially perpendicular thereto.

[0132] Yet another related consideration is that it may be desirable to size the intercostal pump 111 relative to the distance between the first rib 412 and the second rib 414 at end-inspiration such that the intercostal pump 111 is at least partially compressed even when the first rib 412 and the second rib 414 are relatively separated. In this way, the change in distance between the first rib 412 and the second rib 414 during breathing can be translated into a larger volume change within the intercostal pump 111.

[0133] Yet another related consideration is that it may be desirable to position the intercostal pump 111 relative to the first rib 412 and the second rib 414 such that the intercostal pump 111 can be cyclically deformed during breathing by relative movement of the first rib 412, the second rib 414, the chest wall, and / or other tissue of the lungs, such that the volume of the interior space 330 of the intercostal pump 111 changes cyclically with breathing, thereby causing fluid to be pumped.

[0134] c. Valve structure

[0135] Figure 12 Cross-sectional views of a one-way inlet valve in a closed state and an open state, and cross-sectional views of a one-way outlet valve in a closed state and an open state are shown. In Panel A, the one-way inlet valve 320 is shown in a closed state, wherein the one-way inlet valve frame 340 encloses the one-way inlet valve 320 and provides structure and support for the one-way inlet valve 320. In Panel B, the one-way inlet valve 320 is shown in an open state. The size and shape of the one-way inlet valve frame 340 can be selected to provide a connection point or an interconnectable joint with the first tube 120. In Panel C, the one-way outlet valve 322 is shown in a closed state, wherein the one-way outlet valve frame 342 encloses the one-way outlet valve 322 and provides structure and support for the one-way outlet valve 322. In Panel D, the one-way outlet valve 322 is shown in an open state. The size and shape of the one-way inlet valve frame 342 can be selected to provide a connection point or an interconnectable joint with the first tube 122.

[0136] For the one-way inlet valve 320, when the one-way inlet valve 320 is in the Figure 12 When the valve is in the closed position shown in panel A, the pressure difference across the valve is such that pressure P1 ≤ P2 + P c , where P1 and P2 are the pressures at the locations shown in Panel A, and P c is the opening pressure of the valve. Similarly, when the one-way inlet valve 320 is in the Figure 12 In the open position shown in panel B, the pressure difference across the valve is such that pressure P1>P2+P c , where P1 and P2 are the pressures at the locations shown in Panel B, and P c Again, there is the opening pressure of the valve.

[0137] For the one-way outlet valve 322, when the one-way outlet valve 322 is in the Figure 12 In the closed position shown in panel C, the pressure difference across the valve is such that pressure P2 ≤ P3 + P c , where P2 and P3 are the pressures at the locations shown in Panel C, and P c is the opening pressure of the valve. Similarly, when the one-way outlet valve 322 is in the Figure 12 In the open position shown in panel D of the valve, the pressure difference across the valve is such that pressure P2>P3+P c , where P2 and P3 are the pressures at the locations shown in Panel D, and P c Again, there is the opening pressure of the valve.

[0138] In an embodiment, the one-way inlet valve 320 and the one-way outlet valve 322 are formed as duckbill valves having a thin and generally flat lip defining a slit that can move from a closed position to an open position. In an embodiment, the one-way inlet valve 320 and the one-way outlet valve 322 can have a low cracking pressure P c , so that the valve transitions from the closed state to the open state with a relatively small pressure difference across the valve. The opening pressure P c The reseal pressure may be less than about 25 cmH2O to operate on most patients, preferably less than about 15 cmH2O, more preferably less than about 10 cmH2O or even less than about 5 cmH2O. In an embodiment, the one-way inlet valve 320 and the one-way outlet valve 322 may have a low reseal pressure such that the valves transition from an open state to a closed state with a small pressure differential across the valves. The reseal pressure may be less than about 15 cmH2O to operate on most patients, preferably less than about 10 cmH2O, more preferably less than about 5 cmH2O or even less than about 2 cmH2O.

[0139] Furthermore, in an embodiment, the one-way inlet valve 320 and the one-way outlet valve 322 are configured to undergo minimal deformation when closed and a pressure gradient exists across the valve opposite to the one-way direction of the one-way inlet valve 320 and the one-way outlet valve 322. Specifically, when back pressure exists across the valve, i.e., when P1≤P2+P c The one-way inlet valve undergoes minimal deformation and when there is back pressure on the valve, that is, when P2≤P3+P c, the one-way outlet valve undergoes minimal deformation. By such a design, the volume changes generated in the interior space 330 of the pump body are roughly or substantially converted one-to-one into forward flow through the automatic intercostal pump 111. This resistance to deformation can be assessed as the volume reflux generated when back pressure is applied to the sealed or closed one-way inlet valve 320 and the one-way outlet valve 322. With an applied back pressure of 50 cmH2O or less, the reflux may be less than about 200 microliters to operate on most patients, preferably less than about 100 microliters, more preferably less than about 50 microliters or even less than about 25 microliters. Therefore, the amount of volume pumped forward per cycle (V 向前 ) will be close to, approximately equal to, or equal to the volume change (ΔV 内部空间 ) minus the volumetric deformation of the valve required to reseal the valve (V 重新密封体积 ). It is usually expressed in another way:

[0140] V 向前＝ ΔV 内部空间－ V 重新密封体积

[0141] A non-limiting example of a valve that may be used for the one-way valves 320, 322 is of the type described in U.S. Patent No. 5,261,459, entitled "Miniature Duckbill Valve Having a Low Cracking Pressure and High Flow Rate," the entire contents of which are hereby incorporated by reference.

[0142] d. Alternative pleural and peritoneal automated intercostal pump design

[0143] Figures 1 to 7 Any aspects, features, characteristics, etc. or combinations thereof of the automatic pump-based fluid management system described in FIG. 8 may also be incorporated into FIG. Figure 12 As an example, in order to prevent blockage or clogging of the fluid management system based on the automatic intercostal pump and maintain flow through the system, the first tube 120 can be configured to provide a filtering mechanism for the fluid entering the fluid management system based on the automatic intercostal pump 104. Figure 13, the first tube 120 may include one or more filtered fluid inlet perforations 173. The filtered fluid inlet perforations 173 may take the form of holes in the wall of the first tube 120, thereby allowing fluid to be drawn into the first tube 120. The filtered fluid inlet perforations 173 are sized and shaped such that any fibrin clots, fibrin strands, or other debris that can pass through the filtered perforations 173 can also pass through the entire fluid path of the filtered automatic intercostal pump-based fluid management system 104 without blocking or significantly impeding fluid flow. Alternatively, the filtered fluid inlet perforations 173 are sized and shaped such that each such perforation is smaller than the smallest opening present along the entire fluid path of the filtered automatic intercostal pump-based fluid management system 104. For example, the filtered fluid inlet perforations 173 may be sized and shaped such that the filtered fluid inlet perforations 173 are smaller than the openings in the one-way inlet valve 320 and the one-way outlet valve 322. Therefore, any fibrin clots, fibrin strands, or other debris that may pass through the filtered fluid inlet perforations 173 will be smaller than the smallest opening in the fluid path of the filter-based automatic pump fluid management system 104 and should therefore be able to pass through the fluid path of the filter-based automatic pump fluid management system 102. Figure 13 As illustrated in , the tube inlet end of the first tube 120 may include a closed end, and in some cases may be rounded or smooth to aid in placement of the first tube 120 .

[0144] It may be beneficial to provide a stable position and orientation of the intercostal pump 111 in the intercostal space between the first and second ribs of the pump. Figure 14A The stabilizing and orienting features 200 are disposed on the intercostal pump and in some cases, are disposed around the intercostal pump, such as near the outlet portion of the intercostal pump 111 . Figure 14A The stabilizing and orienting features in FIG are shown as relatively circular, generally conical features having relatively planar surfaces 201 that are annular or partially annular relative to the intercostal pump 111 body and oriented at a suitable angle 203 to the long axis of the intercostal pump 111. In use, as Figure 14B , when the intercostal pump 111 is positioned between the first rib 414 and the second rib 416, the planar surface 201 of the stabilizing and orienting feature 200 interfaces with the first rib 414 and the second rib 416 and any intervening soft tissue to orient the intercostal pump 111 at a desired angle relative to the chest wall, generally determined by angle 203, and provides stability at that angle and stability against movement of the intercostal pump along its axis relative to the chest wall. Although generally illustrated as circular and conical, the overall shape of the stabilizing and orienting feature 200 may be any shape that is primarily used to orient the intercostal pump 111 relative to the chest wall and / or provide stability in the orientation and / or axial position of the intercostal pump 111 relative to the chest wall.

[0145] In order to better accommodate the transition between the pleural cavity and the subcutaneous tissue, which is located between the skin and the pleural cavity, a further embodiment can be constructed. Figure 15A As shown in , a fluid management system 105 based on a fitted automatic intercostal pump includes a fitted pump 112 that is generally or approximately "L-shaped" to better accommodate the transition from the pleural space to the subcutaneous tissue. In more general terms, the fitted pump 112 can be shaped to have an angled portion or transition portion that provides the pump 112 (e.g., between portion 112' and portion 112" described below) with an angled transition of between about 1 degree and 179 degrees, preferably between about 45 degrees and 135 degrees, more preferably between about 75 degrees and 105 degrees, and in some cases, an angled transition of approximately 90 degrees. When positioned within the patient's body, the intercostal portion 112' of the fitted pump 112 is positioned in the intercostal space between the first rib and the second rib, and the subcutaneous portion 112" of the pump 112 is positioned in the subcutaneous tissue beneath the skin and on the outer portion of the thorax. In this configuration and placement, for example, as described with respect to Figure 11A and Figure 11B As described, when the patient breathes, the intercostal portion 112' of the pump 112 is cyclically compressed and decompressed by the first and second ribs, thereby automatically providing a continuous pumping action to the pump and a flow of fluid from the pleural cavity to the peritoneal cavity. In addition, in this configuration and arrangement, the subcutaneous portion 112" of the pump 112 is located on the outside of the thoracic cavity and can be used for cyclic (or non-cyclic) manual compression between the skin and the thoracic cavity, which cyclic (or non-cyclic) manual compression can provide additional pumping action of the pump 112 to supplement the flow of fluid from the pleural cavity to the peritoneal cavity when needed. Figure 15B A schematic cross-sectional view of the pump 112 of the fluid management system 105 based on a fitted automatic intercostal pump is shown.

[0146] Another alternative that better accommodates the transition between the pleural cavity and the subcutaneous tissue of the chest wall and provides stable positioning is Figure 16A. A fluid management system 106 based on a transitional automatic intercostal pump includes an intercostal pump 113 connected to a transition chamber 701 to better accommodate the transition from the pleural space to the subcutaneous tissue. The transition chamber 701 is shown as a cylindrical member, wherein the intercostal pump 113 is connected to a flat first end 710 of the cylindrical member, a flat second end 711 is located on the side of the cylindrical member opposite to the flat first end 710, and a one-way outlet valve frame 342 is incorporated into or attached to the wall of the cylindrical member. When positioned in the patient's body, the intercostal pump 113 is positioned in the intercostal space between the first rib and the second rib, and the transition chamber 701 of the fluid management system 106 based on the transitional automatic intercostal pump is positioned in the subcutaneous tissue under the skin and on the outer portion of the thoracic cavity. In this configuration and placement, for example, as described with respect to Figure 11A and Figure 11B As described, as the patient breathes, the intercostal pump 113 is cyclically compressed and decompressed by the first and second ribs, thereby automatically providing a continuous pumping action to the pump and fluid flow from the pleural cavity to the peritoneal cavity. Furthermore, in this configuration and arrangement, the transition chamber 701 is located on the outside of the pleural cavity and provides a transition of approximately or substantially 90 degrees (or other suitable angles) from the pump inlet end 140 of the first tube 120 to the pump outlet end 142 of the second tube 122 to better accommodate the transition from the pleural cavity to the subcutaneous tissue. The flat first end 710 of the cylindrical member provides a stable interface between the transition chamber 701 and the pleural cavity and helps maintain a stable positioning of the intercostal pump 113 in the intercostal space between the first and second ribs. Although transition chamber 701 is shown as a flat-ended cylindrical member, transition chamber 701 may be any suitable shape that provides a transition of up to 90 degrees (or other suitable angles) from pump inlet end 140 of first tube 120 to pump outlet end 142 of second tube 122, and provides stability for the intercostal pump. Transition chamber 701 may be constructed of any relatively rigid or inflexible material, such as nylon, acrylic, polycarbonate, polyetheretherketone, acrylonitrile-butadiene-styrene copolymer, polyethylene terephthalate, stainless steel, or other suitable materials. However, transition chamber 701 may also be constructed of a relatively more flexible material, as desired. Figure 16B A schematic cross-sectional view of the pump 113 and transition chamber 701 of the fluid management system 106 based on a transitional automatic intercostal pump is shown.

[0147] Another solution that better adapts to the transition between the pleural cavity and subcutaneous tissue and provides stable positioning is Figure 17In this embodiment, the transition chamber 701 is a circular, diamond-shaped feature that is configured and capable of engaging with the thoracic cavity and helps maintain stable positioning of the intercostal pump 113 in the intercostal space between the first and second ribs and the orientation of the intercostal pump 113 relative to the chest wall, in which case the transition chamber 701 provides a substantially 90 degree (or other suitable angle) transition from the pump inlet end 140 of the first tube 120 to the pump outlet end 142 of the second tube 122 and stability of the intercostal pump. Although Figure 17 The approximately 90 degree transition shown in may be desirable, but alternative transition angles are possible, and one such alternative is shown in FIG. Figure 18 In addition, as shown by Figure 19 As indicated by the exemplary flange mushroom shape shown in FIG, the overall shape of the transition chamber 701 can vary. Additional stabilizing features, such as holes 191 in the flange mushroom-shaped transition chamber, can be provided to allow for tissue ingrowth or passage of sutures to secure the transition-type automatic intercostal pump-based fluid management system 106 in place. In such cases, the mushroom-shaped flange portion, or at least a portion of the mushroom-shaped flange portion, can be configured such that the holes 191 in the flange portion do not pierce the interior space 330.

[0148] e. Pleural and peritoneal automatic intercostal pump with manual assist

[0149] Another automatic intercostal pump that adapts to the transition between the pleural space and subcutaneous tissue and provides manual assistance in the pumping action is Figure 20A. The transition-type automatic intercostal pump-based fluid management system 107 with manual assistance includes an intercostal pump 113 connected to a transition chamber 702 to better accommodate the transition from the pleural space to the subcutaneous tissue. The transition chamber 702 is shown as a domed cylindrical member, wherein the intercostal pump 113 is connected to a flat first end 710 of the cylindrical member, a domed second end 712 is located on the side of the cylindrical member opposite the flat first end 710, and a one-way outlet valve frame 342 is incorporated into or attached to the wall of the cylindrical member. In this embodiment, the body of the transition chamber 702 and the flat first end 710 can be constructed of any relatively hard or inflexible material, such as nylon, acrylic, polycarbonate, polyetheretherketone, acrylonitrile-butadiene-styrene copolymer, polyethylene terephthalate, stainless steel, or other suitable material, and the dome-shaped second end 712 can be constructed of polyurethane, silicone, polyvinyl chloride, latex rubber, or other suitable elastic material that is deformable but returns to its original shape. When positioned within the patient, the intercostal pump 113 is positioned in the intercostal space between the first and second ribs, and the transition chamber 702 is positioned in the subcutaneous tissue beneath the skin and on the outer portion of the thorax. In this configuration and placement, for example, as described with respect to Figure 11A and Figure 11B As described, as the patient breathes, the intercostal pump 113 is cyclically compressed and decompressed by the first and second ribs, automatically providing a continuous pumping action and fluid flow from the pleural cavity to the peritoneal cavity. Furthermore, in this configuration and arrangement, the transition chamber 702 is located on the outside of the pleural cavity and provides a transition of up to 90 degrees from the pump inlet end 140 of the first tube 120 to the pump outlet end 142 of the second tube 122 to better accommodate the transition from the pleural cavity to the subcutaneous tissue. The flat first end 710 of the cylindrical member provides a stable interface between the transition chamber 702 and the pleural cavity, while the resilient dome-shaped end 712 faces outward from the pleural cavity and is positioned in the subcutaneous tissue beneath the skin. The subcutaneous resilient dome-shaped end 712 can therefore be used for cyclic (or non-cyclic) manual compression, which can provide additional pumping action when needed to supplement fluid flow from the pleural cavity to the peritoneal cavity. Furthermore, if the material used to make the resilient, dome-shaped end portion 712 of the transition chamber 702 is capable of self-sealing upon puncture, the interior 330 of the manually assisted transitional automated intercostal pump-based fluid management system 107 can be accessed, for example, by inserting a needle through the resilient, self-sealing material of the dome-shaped end portion 712 to aspirate fluid or instill anticoagulants, fibrinolytics, and / or other medications. Although the body and flat first end portion of the transition chamber 702 can be constructed of any relatively hard or inflexible material, the body and flat first end portion of the transition chamber 702 can additionally or alternatively be made of a more flexible material as desired. Figure 20BA schematic cross-sectional view of the pump 113 and transition chamber 702 of the transitional automatic intercostal pump based fluid management system 107 is shown.

[0150] f. Pleural and peritoneal automatic intercostal pump with access port

[0151] Another automatic intercostal pump that adapts to the transition between the pleural cavity and the subcutaneous tissue and provides auxiliary access port 721 is Figure 20A . A transition-type automatic intercostal pump-based fluid management system with an inlet port 107' includes an intercostal pump 113 connected to a transition chamber 702 to better accommodate the transition from the pleural space to the subcutaneous tissue. The transition chamber 702 is shown as a domed cylindrical member, wherein the intercostal pump 113 is connected to a flat first end 710 of the cylindrical member, a domed second end 712 is located on the side of the cylindrical member opposite the flat first end 710, and a one-way outlet valve frame 342 is incorporated into or attached to the wall of the cylindrical member. An auxiliary inlet port 721 is shown as a second domed cylindrical member having a domed end 722 adjacent to the transition chamber 702. In this embodiment, the interior of the auxiliary inlet port 721 is in fluid communication with the interior 330 of the transition chamber, and in turn with the transition chamber 702. In this embodiment, the body of the transition chamber 702, the flat first end 710 of the transition chamber, and the cylindrical member of the auxiliary access port 721 can be constructed from any relatively hard or inflexible material, such as nylon, acrylic, polycarbonate, polyetheretherketone, acrylonitrile-butadiene-styrene copolymer, polyethylene terephthalate, stainless steel, or other suitable materials. The domed second end 712 of the transition chamber 702 can be constructed from polyurethane, silicone, polyvinyl chloride, latex rubber, or other suitable elastic material that can be deformed and returned to its original shape. The domed septum 722 of the auxiliary access port 721 can be constructed from some type of polyurethane, silicone, latex rubber, or other suitable self-sealing material that can be pierced sharply for access but can seal the puncture. When positioned within the patient, the intercostal pump 113 is positioned in the intercostal space between the first and second ribs, and the transition chamber 702 is positioned in the subcutaneous tissue beneath the skin and on the outer portion of the thorax. In this configuration and arrangement, for example, as with respect to Figure 11A and Figure 11BAs described, as the patient breathes, the intercostal pump 113 is cyclically compressed and decompressed by the first and second ribs, automatically providing a continuous pumping action and fluid flow from the pleural cavity to the peritoneal cavity. Furthermore, in this configuration and arrangement, the transition chamber 702 is located on the outside of the pleural cavity and provides a transition of up to 90 degrees from the pump inlet end 140 of the first tube 120 to the pump outlet end 142 of the second tube 122 to better accommodate the transition from the pleural cavity to the subcutaneous tissue. The flat first end 710 of the cylindrical member provides a stable interface between the transition chamber 702 and the pleural cavity, while the resilient dome-shaped end 712 faces outward from the pleural cavity and is positioned in the subcutaneous tissue beneath the skin. The subcutaneous resilient dome-shaped end 712 can therefore be used for cyclic (or non-cyclic) manual compression, which can provide additional pumping action when needed to supplement fluid flow from the pleural cavity to the peritoneal cavity. Furthermore, the self-sealing dome-shaped septum 722 of the auxiliary access chamber 721 can be accessed by piercing the patient's skin with a needle, thereby connecting to the interior space 330 of the transition chamber 702 and directly connecting to the outlet side of the inlet valve 320 and the inlet side of the outlet valve 322, so as to sample the contents of the interior space 330 or instill anticoagulants, fibrinolytic agents, and / or other drugs into the interior space 330 of the transition chamber 702. It should be noted that during sampling from the interior space 330, negative pressure may be generated during the sampling process, thereby causing the inlet valve 320 to open to allow fluid to flow from the pump inlet end 140 of the first tube 120, thereby also enabling indirect sampling of the contents of the first tube 120. Similarly, during the instillation of an anticoagulant, fibrinolytic, and / or other medication into the interior space 330, a positive pressure may be generated during the instillation process, causing the outlet valve 322 to open to allow fluid to flow into the pump outlet end 142 of the second tube 122, thereby also delivering the anticoagulant, fibrinolytic, and / or other medication to the contents within the interior of the second tube 122. Although the body and flat first end of the transition chamber 702 can be constructed of any relatively hard or non-flexible material, the body and flat first end of the transition chamber 702 can additionally or alternatively be made of a more flexible material as desired.

[0152] This concept of using auxiliary access ports to access the interior of a transitional automatic intercostal pump based fluid management system having access port 107' can be further exploited by providing multiple access ports. Figure 22As seen in FIG. 1 , for example, the transition chamber 701 is a circular, diamond-shaped feature or other suitably shaped feature that is capable of engaging the thoracic cavity and thereby helping to maintain stable positioning of the intercostal pump 113 in the intercostal space between the first and second ribs and orientation of the intercostal pump 113 relative to the chest wall. There is a first auxiliary inlet chamber 721′ having a self-sealing dome-shaped diaphragm 722′ in fluid communication with the interior 330 of the transition chamber 701, and a second auxiliary inlet chamber (at FIG. 1 ) having a second self-sealing dome-shaped diaphragm 722″ in fluid communication with the interior of the pump inlet end 140 of the first tube 120. Figure 22 Thus, by passing through the overlying skin and then through the first self-sealing dome-shaped septum 722' of the first auxiliary access chamber 721', fluid can be sampled, or anticoagulants, fibrinolytics, and / or other medications can be selectively instilled into the interior space 330 of the transition chamber 702. Similarly, by passing through the overlying skin and then through the second self-sealing dome-shaped septum 722" of the second auxiliary access chamber, fluid can be selectively sampled, or anticoagulants, fibrinolytics, and / or other medications can be instilled into the interior of the pump inlet end 140 of the first tube 120.

[0153] g. Design of electromechanical automatic pump for pleural and peritoneal membrane

[0154] Reference Figure 23A , an electromechanically automated pump-based fluid management system 108 for moving fluid from a first body compartment to a second body compartment includes a pump 118 that generally has an inlet 130 and an outlet 132 and is capable of moving fluid between the inlet 130 and the outlet 132. The electromechanically automated pump-based fluid management system 108 also includes a first tube 120 and a second tube 122. The inlet 130 and the outlet 132 each communicate between the interior and exterior of the pump 115 and are coupled to the first tube 120 and the second tube 122, respectively. In other words, the inlet 130 and the outlet 132 are configured to provide fluid communication between the first tube 120 and the interior space of the pump 118, and between the second tube 122 and the interior space of the pump 118, respectively.

[0155] In addition, the first tube 120 may include a plurality of perforations or fenestrations 170 that allow fluid to enter the first tube 120 and the pump inlet end 140. Typically, the first tube 120 is configured so that, in use, the perforations 170 can be positioned in an area of ​​the human body from which fluid is to be drained. The pump inlet end 140, on the other hand, is coupled to the inlet 130 of the pump 118. As depicted by the length extension 160, the length of the first tube 120 may vary.

[0156] Similarly, the second tube 122 includes a pump outlet end 142 and a tube outlet end 152. Generally, the second tube 122 is configured so that the tube outlet end 152 can be positioned in an area of ​​the human body to which fluid is to be drained when using the automatic pump-based fluid management system 108. On the other hand, the pump outlet end 142 is coupled to the outlet 132 of the pump 118. As depicted by the length extension 162, the length of the second tube 122 can vary.

[0157] Figure 23B The electromechanical pump 118 includes a pump wall that encloses an interior space 330 with the one-way inlet valve 320 and the one-way outlet valve 322 closed.

[0158] The inlet valve 320 can be located in the interior space 330 of the pump body, generally proximate to the inlet 130. The one-way inlet valve 320 can be any suitable one-way valve, such as any of the one-way valves described herein, and can be made of silicone, for example. The one-way inlet valve 320 is configured to prevent fluid from moving from the interior space 330 of the pump 118 to the inlet 130. At the same time, the one-way inlet valve 320 is configured to allow fluid to move from the inlet 130 to the interior space 330 of the electromechanical pump 118. In other words, the one-way inlet valve 320 is in fluid communication with the inlet 130 to generally provide one-way fluid movement from the inlet 130 to the interior space 330 of the electromechanical pump 118.

[0159] Correspondingly, a one-way outlet valve 322 can be located in the interior space 330 of the pump body, generally proximate to the outlet 132. The one-way outlet valve 322 can be any suitable one-way valve, such as any of the one-way valves described herein, and can be made of silicone, for example. The one-way outlet valve 322 is configured to allow fluid to move from the interior space 330 of the electromechanical pump 118 to the outlet 132. At the same time, the one-way outlet valve 322 is configured to prevent or substantially prevent fluid movement from the outlet 132 to the interior space 330 of the electromechanical pump 118. In other words, the one-way outlet valve 322 is in fluid communication with the outlet 132 to generally provide one-way fluid movement from the interior space 330 of the electromechanical pump 118 to the outlet 132.

[0160] One-way inlet valve frame 340 and one-way outlet valve frame 342 can be incorporated into or attached to the body of electromechanical pump 118 and positioned on the outer periphery of one-way inlet valve 320 and one-way outlet valve 322. Furthermore, the size and shape of one-way inlet valve frame 340 and one-way outlet valve frame 342 can be selected to provide a joint or interconnectable joint between first tube 12 and second tube 122.

[0161] Note that although the one-way inlet valve 320 and the one-way outlet valve 322 are depicted as being located within the interior space 330 of the intercostal pump 118, alternative valve placements are also contemplated. For example, one or both of the one-way inlet valve 320 and the one-way outlet valve 322 could be located external to the pump body, within the inlet pipe 120 and the outlet pipe 122, respectively, or between the inlet pipe 120 and the pump body or between the outlet pipe 122 and the pump body, respectively. The specific placement of the valves is not necessarily critical, so long as the valves provide sufficient one-way fluid flow into and out of the intercostal pump 111.

[0162] In the electromechanical pump 118, a liquid-impermeable membrane 550 separates the interior 330, which is in fluid communication with the one-way inlet valve 320 and the one-way outlet valve 322, from a compartment containing the battery 510, the controller 530, and the electromechanical actuator 540. In the electromechanical pump 118, the electromechanical actuator 540 may be a piezoelectric diaphragm that is connected to the membrane 550, activated and deactivated by the controller 530, and both the piezoelectric diaphragm 540 and the controller 530 may be powered by the battery 510. Figure 23B As shown in FIG, the piezoelectric diaphragm 540 is in a non-activated state, and both the one-way inlet valve 320 and the one-way outlet valve 322 are closed. Figure 23C As shown in , when the controller 530 activates the piezoelectric diaphragm 540, the piezoelectric diaphragm 540 changes shape to deform the membrane 550, causing the membrane 550 to strike the interior 330 of the electromechanical pump 118. This reduces the volume available for fluid in the interior 330, increases the pressure within the interior 330, and opens the one-way outlet valve 322, causing fluid to move from the interior 330 of the electromechanical pump 118 to the pump outlet end 142 of the second tube 122 and ultimately to the tube outlet end 152 of the second tube 122. Figure 23D , when controller 530 deactivates piezoelectric diaphragm 540, piezoelectric diaphragm 540 returns to its original shape and membrane 550 returns to its original shape. This increases the volume available for fluid in interior 330 of electromechanical pump 118 and reduces the pressure within interior 330, thereby closing one-way outlet valve 322 and opening one-way inlet valve 320, allowing fluid to move from the interior of pump inlet end 140 of first tube 120 to interior 330 of electromechanical pump 118. In this manner, cyclic activation and deactivation of piezoelectric diaphragm 540 causes fluid to be pumped.

[0163] In the specific case of recurrent malignant pleural effusions requiring treatment to control symptoms, at the end of a 12-week daily drainage period, 25% of patients will die, and 50% of patients will stop draining fluid because the pleural space will achieve pleurodesis secondary to repeated drainage [Wahidi MW, Randomized trial of pleural fluid drainage frequency in patients with malignant pleural effusions. AJRCCM 2017;195:1050-1057]. In other words, a system that can remove effusion from the pleural space daily will provide adequate treatment for 75% of patients with malignant pleural effusions. The amount of pleural effusion that must be drained from the pleural space can vary greatly from patient to patient and from day to day, and generally, the amount of fluid drained decreases with each subsequent drainage. A typical effusion drainage volume might start at approximately 500 ml per day and decrease to approximately 0 ml per day over 12 weeks. Assume that the reduction in drainage is described by the first-order differential equation given below:

[0164]

[0165] Where dV is the drainage volume in the infinitesimal time interval dt,

[0166] V is the drainage volume, and

[0167] λ is the decay constant,

[0168] Solving this equation yields an exponential decay of drainage of the form

[0169] V(t)=V0e -λt

[0170] Where V(t) is the drainage volume on a given day t, and

[0171] V0 is the drainage volume on day 0.

[0172] Assuming an initial drainage volume of 500 ml on day 0 and a decay constant of 1 / 28, the daily drainage after 12 weeks will be less than 25 ml, and the total drainage volume will be 13.5 liters. Similarly, if the initial drainage on day 0 is as much as 1000 ml, assuming the same decay constant of 1 / 28, the daily drainage after 12 weeks will be less than 50 ml, and the total drainage volume will be 27.1 liters. Therefore, designing a system capable of pumping 27 liters of fluid over a 12-week period will meet the drainage requirements of the vast majority of patients with malignant pleural effusions during the 12-week period, and at least 75% of patients will not require further intervention. The required daily drainage value based on this relationship or any other desired relationship can be placed into a lookup table used to control the electromechanical pump. By reducing the volume pumped each day over time, the life of the power supply can be extended.

[0173] The work that a pump must perform to move fluid from a first location to a second location through a tube can be derived from Bernoulli's equation and is given as:

[0174]

[0175] in

[0176] E 泵 is the energy per unit mass imparted by the pump to the fluid,

[0177] P1 is the pressure at position 1,

[0178] P2 is the pressure at position 2,

[0179] ρ is the density of the fluid,

[0180] is the average velocity of the fluid at position 1,

[0181] is the average velocity of the fluid at position 2,

[0182] g is the gravity acting on the fluid,

[0183] z1 is the height of the fluid at position 1,

[0184] z2 is the height of the fluid at position 2,

[0185] E 摩擦 It is the energy loss due to friction when the fluid flows through the tube.

[0186] The main friction loss for moving fluid through a tube from a first location to a second location can be derived as:

[0187]

[0188] in

[0189] E 摩擦 It is the main energy loss caused by friction when the fluid flows through the pipe.

[0190] f is the friction coefficient of the tube,

[0191] is the average velocity of the fluid as it passes through the tube,

[0192] L is the length of the tube, and

[0193] d is the diameter of the tube.

[0194] Combining these two equations yields:

[0195]

[0196] To determine the energy required by the electromechanical pump 118 to move exudate from a first region 220, which is the patient's pleural cavity, to a second region 230, which is the patient's peritoneal cavity, we can consider a simplified case where the first and second locations are at the same height, the fluid at the first location is static, and the pressure at the second location is higher than the pressure at the first location. In this case, the pump energy equation simplifies to:

[0197]

[0198] If we replace the average velocity in the pipe with the volume flow rate, the relationship becomes

[0199]

[0200] in

[0201] Q2 is the volume flow rate of the fluid through the tube, and

[0202] k is a correction factor that takes into account the velocity distribution, and the pump energy equation becomes:

[0203]

[0204] Examination of the above equations shows that the pump energy is highly dependent on the tubing diameter when the tubing diameter is relatively small. The following example representative values ​​for these terms for the pleural cavity, peritoneal cavity, and potential design features can be considered:

[0205] P1, pleural cavity pressure = -5cmH20 = 490Pa,

[0206] P2, peritoneal cavity pressure = +20cmH20 = 1961Pa,

[0207] ρ, density of exudate = 1,000 kg / m 3 ,

[0208] Q2, the average volume flow rate of the fluid at position 2, where the flow rate is 100 ml / min = 1.667 × 10 -6 m 3 / s,

[0209] f, friction coefficient of silicone tube = 0.5,

[0210] k, correction factor for turbulence = 1,

[0211] L, length of the tube connecting the first and second locations = 30 cm = 0.3 m, and

[0212] d, diameter of the tube = 3mm = 0.003m.

[0213] Substituting these example representative values ​​into the equation yields:

[0214]

[0215]

[0216] Therefore, under the above assumptions, according to this simplified model, each kilogram of mass of exudate moving from the first region 220 of the patient to the second region 230 of the patient consumes 8.041 J of energy.

[0217] To further refine the model, if a second friction term is added to the above equation to account for the narrow connector with a length of 1 cm and a diameter of 1 mm, then

[0218]

[0219] It is interesting to note that the frictional energy contributed by a connector 1 cm long and 1 mm in diameter is 8 times (8X) the frictional energy contributed by a 30 cm length of 3 mm diameter tubing. Thus, under the modified assumptions described above, including a narrow tubing 1 cm long and 1 mm in diameter, 53.09 J of energy would be consumed per kilogram of exudate moved from the patient's first region 220 to the patient's second region 230. Furthermore, for an electromechanical pump 118 operating at 50% efficiency, 106.2 J of energy would have to be provided to move 1 kg of exudate. Therefore, during the first three months, when an estimated 27 liters of exudate must be moved, the power source should ideally be able to provide at least 2,866.9 J of energy. Furthermore, to allow for a greater pressure gradient between the first region 220 and the second region 230 of the patient, to allow for higher friction losses in the tube (particularly given the diameter of the tube), and to allow for lower efficiency, the power source should preferably be able to provide at least about 5,000 J of energy, or more preferably, at least about 10,000 J of energy or even about 15,000 J. For reference, a AA battery rated at 2800 mAH and operating at 1.5 V contains 15,120 J of energy.

[0220] In addition, in E 泵 Given the strong dependence on the diameter of the tubing and connections required to transfer fluid between the first area 220 and the second area 230, it may be desirable for the electromechanical automatic pump-based fluid management system 108 to have all tubing, connections, and opening diameters (notwithstanding the operation of the one-way valves, e.g., opening and closing) equal to or greater than 1 mm, preferably equal to or greater than 2 mm, more preferably equal to or greater than 3 mm, or even up to or greater than 4 mm. Alternatively, it may be desirable to limit the length of connections and openings less than 1 mm to a length equal to or less than 1 cm, preferably a length equal to or less than 0.5 cm, and more preferably a length equal to or less than 0.2 cm.

[0221] The activation and operation of the electromechanical pump 118 can be optimized based on the fluid movement demand between the first region 220 and the second region 230 of the patient. For the pleural to peritoneal cavity described above, the demand for exudate movement may be 500 ml on day 1 and decrease over time to less than 25 ml by day 84, or 1 liter on day 1 and decrease over time to less than 50 ml by day 84. For this scenario, the controller 530 can be programmed to turn the pump on for a period of time based on the pump's capacity, which will pump the required volume of fluid on the first day, and then reduce the pump on time on each subsequent day, for example, according to the relationship:

[0222] V(t)=V0e -λt

[0223] in

[0224] As an example, V0 is 1 liter,

[0225] λ is 1 / 28, and

[0226] t is the number of days after implantation.

[0227] Alternatively, the pump on time can be based on a lookup table that has the daily required drainage volume as input. The electromechanical pump 118 can be turned on once a day to pump the entire required volume of fluid at once, or the total pump on time can be divided throughout the day. For example, the electromechanical pump 118 can be turned on once an hour to pump approximately 1 / 24 of the total daily drainage volume required. Other patterns of pump on and pump off times can also be used.

[0228] In addition, the controller 530 can be designed with a sensing feature that can monitor fluid flow while the electromechanical pump 118 is on and can shut down the electromechanical pump 118 if fluid flow stops. For example, if the initial estimated or expected fluid flow on day 1 is 1 liter, but flow stops after 550 ml of fluid has been pumped, the controller 530 can be programmed to shut down the electromechanical pump 118. Alternatively, the electromechanical pump 118 can simply be turned on every hour or other suitable time period and remain on until the fluid flow drops below a predetermined value, such as, but not limited to, 1 ml / min or 5 ml / min. In addition, the controller 530 can be designed with a sensing feature that can monitor the pressure inside the electromechanical pump 118 while it is on and can be programmed to shut down the electromechanical pump 118 if the pressure inside the pump drops below a predefined value. For example, the controller may shut down the electromechanical pump 118 when the pressure drops below about 5 cmH2O, below about 0 cmH2O, below about -5 cmH2O, below about -10 cmH2O, or below about -20 cmH2O.

[0229] In the electromechanical pump 118, the electromechanical actuator 540 is described as a piezoelectric diaphragm, but alternative actuators for diaphragm pumps, such as, but not limited to, electric motors and cams, among other alternatives, may be used to achieve similar effects. In practice, the electromechanical pump 118 may be a gear pump, a progressive cavity pump, a rotary vane pump, a diaphragm pump, a piezoelectric diaphragm pump, a plunger pump, a peristaltic pump, a cam pump, a piston pump, a centrifugal pump, or any other type of pump.

[0230] h. Design of pleural and peritoneal electromechanical pumps and automatic intercostal pumps

[0231] Reference Figure 24A and Figure 24B , shows a fluid management system 109 based on a combined electromechanical pump and an automatic intercostal pump, which is combined with a fluid management system 109 as described with reference to e.g. Figure 11A and Figure 11BThe intercostal pump 113 operates as described and as described with reference to e.g. 23A to 23D The electromechanical pump 118 is described. These pumps can share a common interior 330, a one-way inlet valve 320, and a one-way outlet valve 322. In operation, the intercostal pump 113 can cyclically compress and decompress between the first and second ribs to produce a continuous flow of fluid between the pump inlet 130 and the pump outlet 132. The electromechanical pump 118 can be configured to replenish the fluid flow as needed.

[0232] 5. Other fluid management systems based on automatic pumps

[0233] The fluid management system including the automatic pump 110 can be used to drain fluid from and to various areas of a patient's body. That is, the fluid management system including the intercostal pump described herein is not limited to uses involving draining fluid from a patient's pleural cavity to a patient's peritoneal cavity.

[0234] One example of an alternative use of a fluid management system incorporating the intercostal pump described herein is draining fluid from a patient's cerebrospinal region. According to this alternative use, tube 120 can be configured to extend from automated pump 110 to the patient's cerebrospinal region, such that tube inlet end 150 can be positioned within the patient's cerebrospinal region. In this manner, excess cerebrospinal fluid can be drained.

[0235] Another example of an alternative use of a fluid management system incorporating the intercostal pump described herein is to drain fluid from the pericardial region of a patient.

[0236] Other alternative uses are certainly possible. In general, a fluid management system incorporating the intercostal pumps described herein can be used to drain fluid to and from any combination of areas in a patient's body that can be adequately fluidically connected to any of the automatic intercostal pump-based fluid management systems 100 described herein.

[0237] 6. Automatic pump-based fluid management system with reservoir

[0238] Reference Figure 25 , a fluid management system 1000 based on an automatic intercostal pump is shown with at least a portion of a pump 1010 and a first tube 120 implanted within a patient's body 200, and at least a portion of a second tube 122 located outside the patient's body, thereby providing a means for draining fluid from a first region 220 within the patient's body to an external reservoir 1020 located outside the patient's body. In one embodiment, as in Figure 25 In the example embodiment depicted in , fluid is drained from the patient's pleural cavity 220 to an external reservoir 1020 .

[0239] In an embodiment, the automatic intercostal pump 1010 is configured such that the automatic intercostal pump 1010 can be at least partially positioned in the intercostal region between two ribs. In other words, when implanted, the intercostal pump 1010 extends through the patient's intercostal space or at least a portion of the patient's intercostal space. Thus, the first tube 120 and the corresponding pump inlet 130 are disposed on the interior of the patient's thoracic cavity. The second tube 122 and the corresponding pump outlet 132 are disposed on the exterior of the patient's thoracic cavity. In this manner, upon breathing and corresponding compression / decompression of the thoracic cavity, the patient 210 will automatically cause the intercostal pump 1010 to operate (e.g., "pump"). This configuration allows the patient to move around with minimal hardware while fluid in the pleural cavity is actively pumped out.

[0240] 7. Method for draining fluid from a patient's body using an automated pump-based fluid management system

[0241] The method of draining a fluid from a first region of a patient or person's body to a second region of the patient or person's body can generally be performed by implanting and using any of the various automated pump-based fluid management systems described herein. Figure 26A In method 800, an example of a method for draining pleural fluid is described. At step 802, an intercostal pump, such as intercostal pumps 110, 111, 112, etc., of an automated pump-based fluid management system, such as any of the various embodiments described herein, is implanted in a patient's intercostal space such that the pump can be compressed between a first rib, such as first rib 412, and a second rib, such as second rib 414. The intercostal pump, such as intercostal pumps 110, 111, 112, etc., can be implanted using any suitable surgical technique, whether known or yet to be discovered. At step 804, fluid communication is established between a first region of the patient and an inlet 130 of the intercostal pump, such as intercostal pumps 110, 111, 112, etc. For example, a first tube, such as first tube 120, can extend from the patient's pleural cavity to the inlet 130. At step 806, fluid communication is established between a second region of the patient and an outlet 132 of the intercostal pump, such as intercostal pumps 110, 111, 112, etc. For example, a second tube, such as second tube 122, can extend from outlet 132 to the patient's peritoneal cavity. At step 808, an intercostal pump, such as intercostal pumps 110, 111, 112, etc., is periodically compressed and / or electromechanically pumped—depending on which of the various embodiments described above is used—to move fluid from a first region of the patient via the first tube, through the intercostal pump, and via the second tube into a second region of the patient.

[0242] For example, an intercostal pump, such as intercostal pumps 110, 111, 112, etc., can be compressed between a first rib, such as first rib 412, and a second rib, such as second rib 414, during a patient's respiratory cycle. Figure 26B In method 850, at step 852, an intercostal pump, such as intercostal pumps 110, 111, 112, etc., is depressurized. For example, the intercostal pump, such as intercostal pumps 110, 111, 112, etc., is initially compressed between first rib 412 and second rib 414 while the patient's ribs are in a contracted state (i.e., the patient has previously exhaled). When the patient inhales, the chest cavity expands, and first rib 412 and second rib 414 move away from each other. Thus, the intercostal pump, such as intercostal pumps 110, 111, 112, etc., is depressurized. At step 854, the intercostal pump, such as intercostal pumps 110, 111, 112, etc., draws fluid. That is, due to the depressurization of the intercostal pump, such as intercostal pumps 110, 111, 112, etc., at step 852, the pumping force draws fluid into the interior space, such as interior space 330, of the intercostal pump, such as intercostal pumps 110, 111, 112, etc. At step 856, an intercostal pump, such as intercostal pumps 110, 111, 112, etc., is compressed. For example, the intercostal pump, such as intercostal pumps 110, 111, 112, etc., is compressed between first rib 412 and second rib 414 due to the patient's chest contraction (i.e., the patient exhales). When the patient exhales, the chest contractions and first rib 412 and second rib 414 move toward each other. As a result, the intercostal pump, such as intercostal pumps 110, 111, 112, etc., is compressed. At step 858, the intercostal pump, such as intercostal pumps 110, 111, 112, etc., outputs fluid. That is, due to the compression of the intercostal pump, such as intercostal pumps 110, 111, 112, etc., at step 856, the pumping force forces fluid out of the interior space, such as interior space 330, of the intercostal pump, such as intercostal pumps 110, 111, 112, etc. In some approaches, an electromechanical pump, such as electromechanical pump 118 , may be used instead of or in addition to an intercostal pump, such as intercostal pumps 110 , 111 , 112 , etc.

[0243] 8. Other matters

[0244] As used herein, the terms "substantially" or "generally" refer to the complete or nearly complete extent or degree of an action, characteristic, attribute, state, structure, item, or result. For example, an object enclosed by "substantially" or "generally" would mean that the object is either completely enclosed or almost completely enclosed. In some cases, the precise degree of permissible deviation from absolutely complete may depend on the specific circumstances. However, in general, almost complete will have generally the same overall effect or result as if absolute and complete completeness were obtained. When used in a negative sense, the use of "substantially" or "generally" is equally applicable to referring to the complete or almost complete lack of an action, characteristic, attribute, state, structure, item, or result.

[0245] Unless otherwise noted, as used herein, the phrases “at least one of [X] and [Y]” or “at least one of [X] or [Y]” mean that the embodiment may include component [X] but not component [Y], the embodiment may include component [Y] but not component [X], or the embodiment may include both component [X] and component [Y], where [X] and [Y] are different components that may be included in embodiments of the present disclosure. Similarly, when used with respect to three or more components, such as “at least one of [X], [Y], and [Z]” or “at least one of [X], [Y], or [Z],” these phrases mean that the embodiment may include any one of the three or more components, any combination or subcombination of any of the components, or all of the components.

[0246] Example embodiments of an automatic pump-based fluid management system are described above. These example embodiments are not intended to be exhaustive or to limit the invention to the precise form disclosed. Obvious modifications or variations are possible in light of the above teachings. The various embodiments were chosen and described to provide the best illustration of the principles of the disclosure and its practical application, and to enable one of ordinary skill in the art to utilize the various embodiments with various modifications as are suited to the particular use contemplated. All such modifications and variations are within the scope of the disclosure as determined by the appended claims when interpreted in accordance with the breadth to which they are fairly, legally, and equitably entitled.

Claims

1. A pump-based fluid management system, comprising: a pump body having an interior chamber in fluid communication with the inlet and the outlet; a one-way inlet valve proximate the inlet and configured to allow fluid to move from the inlet to the interior chamber and to at least substantially prevent fluid from moving from the interior chamber to the inlet; as well as a one-way outlet valve proximate the outlet and configured to allow fluid to move from the interior chamber to the outlet and to at least substantially prevent fluid from moving from the outlet to the interior chamber; wherein the pump body is constructed of an elastic, flexible material, the elastic, flexible material being selected such that when the pump body is implanted between adjacent ribs of a user-patient, expansion and contraction of the user-patient's chest cavity respectively result in decompression and compression of the pump body, and automatically pumping the fluid received at the inlet through the pump body and out of the outlet; and The pump body further comprises a manually depressible portion, the manually depressible portion being formed of a deformable material that returns to its original shape after deformation, the manually depressible portion being configured to face outward from the chest cavity of the patient user when the pump body is implanted between adjacent ribs of the patient user, and the manually depressible portion being configured to pump fluid from the internal chamber to the outlet when pressed.

2. The pump-based fluid management system of claim 1, wherein: The manually depressible portion comprises a generally dome-shaped portion of the pump body.

3. The pump-based fluid management system of claim 2, wherein: The generally dome-shaped portion is constructed of a self-sealing material.

4. A pump-based fluid management system according to any one of claims 1 to 3, wherein: At least a portion of the pump body is coated with at least one of an anticoagulant factor or a fibrinolytic factor.

5. The pump-based fluid management system of claim 4, wherein: At least a portion of the pump body is coated with heparin.

Images