Automatic pleural peritoneal pump

Abstract

An automatic pump-based fluid management system, as described herein, includes an intercostal pump, typically an elastically 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 the patient's body, such as a pleural cavity of the patient. 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 a peritoneal cavity of the patient. In use, the intercostal pump is disposed between a first rib and a second rib of a patient. The intercostal pump is operated by being continuously compressed and decompressed between the first rib and the second rib as the patient breathes.

Description

[0001] This application is a divisional application of the invention patent application filed on March 10, 2021, with application number 202180030442.9 (PCT / US2021 / 021643) and entitled "Automatic Pleural and Peritoneal Pump".

[0002] Cross-reference to related applications

[0003] This application claims the benefit of priority to U.S. Patent Application No. 16 / 819,352, filed March 16, 2020, entitled “Automatic Pleural-Peritonal Pump,” the entire disclosure of which is incorporated herein by reference.

[0004] This application also relates to U.S. Patent Application No. 13 / 968,479, filed August 16, 2013, entitled “Systems and Methods for Draining Bodily Fluid via an Intercostal Pump,” the entire disclosure of which is incorporated herein by reference. Background Technology

[0005] Many techniques for draining fluids involve using a pump combined with a shunt or catheter to drain fluid from one cavity of 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, as well as other possibilities.

[0006] One drainage technique is the drainage of pleural fluid used to treat pleural effusion. Pleural fluid is typically a low-protein fluid present in relatively small amounts (usually 10 to 20 ml) in each pleural cavity of a patient. The pleural cavity is the space between the visceral pleura (the membrane that lies above the entire outer surface of each lung) and the parietal pleura (the membrane that forms on the inner side of the chest wall in each hemiplegia). The small amount of pleural fluid in each pleural space is very thinly dispersed between the visceral and parietal pleura, thus providing a large surface tension that mechanically connects the lung to the chest wall while lubricating these surfaces, allowing the lung to slide along the chest wall during respiration. In normal, healthy individuals, pleural fluid is constantly produced, primarily from fluid leaking from the blood and lymphatic vessels in the visceral pleura that covers the outer surface of the lung, and is reabsorbed at a substantially equal rate by lymphatic vessels located in the parietal pleura that forms on the chest wall. This dynamic balance involves multiple fluid exchanges per day, maintaining a low total volume in the range of 10 to 20 ml. However, in certain abnormal conditions such as infection, inflammation, malignancy, heart failure, liver failure or kidney failure and other diseases, the net flow of pleural fluid in the pleural cavity becomes unbalanced, in which fluid production increases, reabsorption decreases, or both are present, which leads to an excessive accumulation of fluid in the pleural space (e.g., approximately several hundred milliliters to several liters).

[0007] An excessive accumulation of pleural fluid is called pleural effusion, and pleural effusion adds an extra mass that must be moved with each breath, potentially causing pathological compression of the lung tissue. This makes breathing quite difficult or obstructs the breathing process. Pleural effusion can cause symptoms such as difficulty breathing, shortness of breath, chest pain, and / or chronic cough, and can significantly impact a patient's quality of life.

[0008] Currently, pleural effusion affects approximately 1.5 million new patients annually in the United States. Many of these effusions are chronic, recur if drained, and can be quite symptomatic and debilitating for patients. A common type of recurrent symptomatic pleural effusion is a result of malignancy. In the United States, more than 200,000 cases of malignant pleural effusion occur each year, and more than half of these patients with malignant pleural effusion experience recurrent symptoms directly caused by their effusion.

[0009] Treatment options for recurrent, symptomatic pleural effusion can be categorized as: 1) repeated drainage of pleural effusion and 2) elimination of pleural space.

[0010] One approach to treating recurrent, symptomatic pleural effusion is repeated therapeutic thoracentesis. Thoracentesis involves inserting a needle and catheter device into the pleural cavity, at which point the needle is removed, leaving the catheter in the pleural space. The catheter remains in place and thus acts as a drainage tube, allowing excess pleural fluid to move from the pleural space to a collection reservoir outside the body. This procedure usually 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 in informing their doctors that their symptoms have improved and delays in organizing and providing repeat thoracentesis, patients often experience effusion-related symptoms for much of their lives. Furthermore, thoracentesis is painful and uncomfortable and is frequently accompanied by complications, such as pneumothorax (i.e., collapse of the lung due to air accumulation in the pleural cavity) in up to 11% of patients, and serious bleeding or infection in many other patients.

[0011] Another treatment option is pleurodesis. Pleurodesis involves closing the pleural space and adhering the surfaces of the visceral and parietal pleura by instilling a sclerosing agent into the pleural space. In one approach, the sclerosing agent is introduced via a chest tube inserted into the patient under moderate sedation or general anesthesia to drain pleural fluid in a manner similar to drainage achieved in thoracentesis. After drainage of the pleural effusion, the sclerosing agent is instilled into the pleural cavity through the tube to completely cover the visceral and parietal membranes, causing these membranes to adhere permanently to each other, thus closing and eliminating the pleural cavity. 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 breathing difficulties, and in up to one-third of patients, it fails to provide symptom relief for more than a few weeks.

[0012] 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 chest. Pleural fluid is drained, and the pleural space is thoroughly examined to allow for more differentiated application of sclerosing agent to any abnormal areas. In some cases, thoracoscopic pleurodesis can be more effective than chest tube pleurodesis. Unfortunately, thoracoscopic pleurodesis typically still requires a prolonged hospital stay of 4 to 7 days and can be quite painful, potentially causing pleurodesis-related breathing difficulties, and in many patients, failing to provide symptom relief for more than several weeks.

[0013] Another treatment option is long-term indwelling pleural catheterization. This type of catheter is permanently placed in the patient's body, allowing pleural fluid to drain to an external reservoir on an intermittent but continuous basis. That is, one end of the pleural catheter is placed inside the affected pleural space within the patient's body, while the other end extends outside the patient's body and remains exposed for an extended period. Chronic indwelling catheterization has proven to produce a relatively high success rate in treating effusion-related symptoms and involves a relatively short hospital stay of approximately one day. However, because the catheter pierces through the patient's skin, with one part inside and one part outside the body, a significant percentage of patients—approximately 8%—become victims of infection. Furthermore, patients suffer from discomfort, irritation, and distress due to the exposed indwelling catheter. Finally, to achieve relief of effusion-related symptoms, the patient or their caregiver must actively approach the external portion of the catheter, connect it to the external reservoir, and drain the effusion from the pleural space into the reservoir.

[0014] Another approach is pleural-peritoneal shunt. A pleural-peritoneal shunt provides a permanent catheter between the pleural cavity and the peritoneal cavity or abdomen, allowing fluid to move from the pleural cavity to the peritoneal cavity, unlike an external reservoir. Once in the peritoneal cavity, the fluid is reabsorbed into the patient's bloodstream via blood and lymphatic vessels located in the abdomen. In popular pleural-peritoneal shunts, the shunt has a pump chamber that must be manually activated by the patient or caregiver to move the pleural fluid. The pleural-peritoneal shunt runs under the skin from the chest to the abdomen, with the pump chamber embedded in a subcutaneous pouch covering the pleural cavity. Like long-term indwelling catheters, pleural-peritoneal shunts have shown a relatively high success rate in treating fluid-related symptoms and involve a relatively short 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 pleural-peritoneal shunts include a relatively high incidence of shunt-specific complications, such as a relatively high rate of fluid clotting within the shunt. Finally, in order to relieve symptoms related to effusion, patients or their caregivers must actively and repeatedly compress the pump chamber to transfer the effusion from the pleural space to the peritoneal space, causing great discomfort and inconvenience.

[0015] Other drainage techniques exist. These techniques include, but are not limited to, the drainage of pericardial fluid, cerebrospinal fluid, peritoneal fluid, urine, bile, and lymph. These fluids can be drained into cavities including, but not limited to, the pleural space, peritoneal space, bile duct, stomach, lymphatic vessels including the thoracic duct, veins including the vena cava, and the bladder.

[0016] The background description provided herein is for the purpose of generally presenting the background of this disclosure. Within the scope described in this background section, the work of the currently designated inventors and aspects that might otherwise not qualify as prior art at the time of filing are neither explicitly nor implicitly acknowledged as contravening prior art. Summary of the Invention

[0017] There is a need for a novel pleural fluid drainage technique that offers high success rates in treating pleural effusion, avoids high infection rates and other complications, eliminates the need for lengthy hospital stays and / or repeated hospital visits, and avoids the inconvenience of manually compressing the pump chamber multiple times a day or physically connecting catheters to external reservoirs to relieve symptoms. An automated pump-based fluid management system, as described herein, provides this novel and beneficial drainage technique.

[0018] The automatic pump-based fluid management system described herein includes a pump, typically a pump chamber having a first check valve at an inlet leading to the pump chamber and a second check valve connected in series with the first valve at an outlet of the pump chamber. The volume of the pump chamber in contact with the fluid can be increased or decreased. An inlet is attached to a first tube extending from the automatic pump to a first region of the patient's body, such as the patient's pleural cavity. An outlet is connected to a second tube extending from the automatic pump to a second region of the patient's body. The second region of the patient's body may be, for example, the patient's peritoneal cavity. During operation of the automatic pump, fluid is transferred from the first region of the patient's body to the second region.

[0019] In one implementation, the pump chamber of the automatic pump is a 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 this use 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 periodically changing the volume of the pump chamber. When the patient inhales, the patient's thoracic 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 thoracic 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.

[0020] In another embodiment, the pump chamber of the automatic pump is an elongated, 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 located in the subcutaneous tissue between the patient's pleural cavity and skin. Therefore, the automatic pump can operate in two ways: first, as the patient breathes, the pump chamber between the first and second ribs is continuously compressed and decompressed, thereby periodically changing the volume of the pump chamber; and second, the patient or caregiver manually compresses the portion of the elongated pump chamber located between the patient's pleural cavity 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 excessive effusion is determined in the pleural space based on patient symptoms, radiographic examination, or ultrasound, the patient or caregiver may be able to repeatedly and manually compress the portion of the pump chamber located between the patient's or caregiver's fingers or hand and the pleural cavity to provide additional pumping action.

[0021] In another embodiment, the pump chamber of the automatic pump has a first portion and a second portion. The first portion includes an elastic flexible tube disposed between a first rib and a second rib within the patient's body, and the second portion includes a semi-rigid chamber with an electromechanical pump that can assist the pumping action provided by the first portion. Thus, the automatic pump can operate in such a way that, firstly, during the patient's breathing, the first portion of the pump chamber between the first and second ribs is continuously compressed and decompressed, thereby periodically changing the volume of the pump chamber, and periodically changing the volume of the pump chamber generated by the electromechanical pump in the second portion. Therefore, when the patient inhales, the first portion of the pump chamber between the first and second ribs is decompressed and filled with exudate from the pleural space, and when the patient exhales, the first portion of the pump chamber is compressed, expelling fluid from 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 without relying on the action of the pump chamber between the first and second ribs.

[0022] Using an automated pump as described herein avoids some of the drawbacks of known fluid drainage techniques. For example, intercostal pumps operate to drain fluid periodically, continuously, and automatically, without requiring the patient to manually compress the pump or to remove the fluid to the outside of the patient's body. Furthermore, due to the continuous operation of the intercostal pump, improved performance can be achieved by reducing the occurrence of clots, which is observed in other fluid drainage systems that may remain inactive for extended periods.

[0023] The foregoing provides a simplified overview of one or more embodiments of this disclosure in order to provide a basic understanding of such embodiments. This overview is not a broad summary of all contemplated embodiments and is neither intended to identify key or critical elements of all embodiments, nor to describe the scope of any or all embodiments. Other embodiments of this disclosure will become apparent to those skilled in the art from the following detailed description, which illustrates and describes illustrative embodiments of the invention. As will be appreciated, various embodiments of this disclosure are capable of being modified in a variety of obvious ways, all without departing from the scope of this disclosure. Therefore, the drawings and detailed description are to be regarded in an illustrative rather than restrictive manner. Attached Figure Description

[0024] The invention disclosed herein will be more readily understood by reading the description with reference to the accompanying drawings, which form part of the specification, in which:

[0025] Figure 1 A perspective view of an automatic pump-based fluid management system is shown, which includes a pump and also includes an inlet pipe and an outlet pipe (the inlet pipe and outlet pipe are schematically shown as shortened for illustrative purposes).

[0026] Figure 2A , Figure 2B and Figure 2C An automated pump-based fluid management system implanted in a patient is shown;

[0027] Figure 3 The diagram shows representative pleural and peritoneal pressures that change during inspiration and expiration.

[0028] Figure 4 A perspective view of an automatic pump-based fluid management system is shown, which includes a pump and also includes an inlet pipe and an outlet pipe (the inlet pipe and outlet pipe are schematically shown as shortened for illustrative purposes) having perforations or openings designed to prevent blockage and improve fluid flow.

[0029] Figure 5 A perspective view of an automatic pump-based fluid management system is shown, which includes a pump and also includes an inlet pipe and an outlet pipe (the inlet and outlet pipes are schematically shown as shortened for illustrative purposes). The inlet pipe has a rounded and closed end and a small opening designed to prevent fibrin chains and particles from entering the conduit and pump and thus prevent system blockage.

[0030] Figure 6A perspective view of an automatic pump-based fluid management system is shown, which includes a pump, perforated or vented inlet and outlet pipes (the inlet and outlet pipes are schematically shown as shortened for illustrative purposes), and a fibrinolytic band and / or anticoagulant band located on the inlet pipe to prevent fibrin and / or clot formation and thus prevent system blockage.

[0031] Figure 7 A perspective view of an automatic pump-based fluid management system is shown, which includes a pump, a perforated or windowed inlet and outlet pipes (the inlet and outlet pipes are schematically shown as shortened for illustrative purposes), and a strip of pro-fibrinating material located on the inlet pipe to induce the formation of local fibrin and / or clots away from the window and thereby prevent system blockage.

[0032] Figure 8A A perspective view of a fluid management system based on an automatic inter-rib pump for inter-rib applications is shown, and the fluid management system based on the automatic inter-rib pump includes a pump chamber and includes perforated or vented inlet and outlet pipes (the inlet and outlet pipes are schematically shown as shortened for illustrative purposes).

[0033] Figure 8B A perspective view of a fluid management system based on an automatic inter-rib pump for inter-rib applications is shown, and the fluid management system based on the automatic inter-rib pump includes a pump chamber and an inlet pipe with a linear fluid passage and a perforated or vented outlet pipe (the inlet and outlet pipes are schematically shown as shortened for illustrative purposes).

[0034] Figure 9 A fluid management system based on an automated intercostal pump, implanted in a patient, is shown.

[0035] Figure 10A , Figure 10B , Figure 10C and Figure 10D A schematic cross-sectional view of a pump chamber with a one-way inlet valve and a one-way outlet valve is shown, along with various positions or states of the one-way inlet valve and the one-way outlet valve when the pump chamber is compressed.

[0036] Figure 10E and Figure 10F A schematic cross-sectional view of a pump chamber with a one-way inlet valve and a one-way outlet valve, and a reinforcing member located inside the pump chamber designed to provide a greater volume change of the pump chamber under a given force, is shown.

[0037] Figure 11A and Figure 11B A three-dimensional diagram of a fluid management system based on an automated intercostal pump is shown, as well as the relationship of the pump chamber relative to the patient's ribs during inspiration and expiration.

[0038] Figure 12 A cross-sectional schematic diagram of a one-way inlet valve in the closed and open states and a cross-sectional schematic diagram of a one-way outlet valve in the closed and open states are shown.

[0039] Figure 13 A perspective view of a fluid management system based on an automatic inter-rib pump is shown, which includes a pump chamber and an inlet pipe with a circular and closed end, an inlet orifice sized relative to an inlet valve and an outlet valve, and an outlet pipe (the inlet and outlet pipes are schematically shown as shortened for illustrative purposes).

[0040] Figure 14A A perspective view of a fluid management system based on an automatic inter-branch pump is shown, which includes a pump chamber, an inlet pipe, an outlet pipe, and stabilization and directional features (the inlet and outlet pipes are schematically shown as shortened for illustrative purposes).

[0041] Figure 14B A perspective view of an automated intercostal pump-based fluid management system with stabilizing and directional features is shown, along with the relationship between the pump chamber and the patient's ribs.

[0042] Figure 15A A perspective view of a fluid management system based on an automated intercostal pump is shown. The fluid management system includes a pump shaped to better accommodate the transition from the pleural space to the subcutaneous tissue, and includes perforated or fenestrated inlet and outlet tubes (the inlet and outlet tubes are schematically shown as shortened for illustrative purposes).

[0043] Figure 15B It shows Figure 15A A schematic cross-sectional view of the pump in the fluid management system based on an automatic inter-rib pump is shown.

[0044] Figure 16A A perspective view of a fluid management system based on an automated intercostal pump is shown. The fluid management system includes a pump shaped to better accommodate the transition from the pleural space to the subcutaneous tissue and to better prevent displacement that would occur once placed. The fluid management system also includes perforated or fenestrated inlet and outlet tubes (the inlet and outlet tubes are schematically shown as shortened for illustrative purposes).

[0045] Figure 16B It shows Figure 16A A schematic cross-sectional view of the pump in the fluid management system based on an automatic inter-rib pump is shown.

[0046] Figure 17An alternative perspective view of an automated intercostal pump-based fluid management system is shown, which includes a pump shaped to better accommodate the transition from the pleural space to the subcutaneous tissue and to better prevent displacement that would occur once placed (the inlet and outlet tubes are schematically shown as shortened for illustrative purposes).

[0047] Figure 18 A perspective view of an alternative fluid management system based on an automated intercostal pump is shown, which includes a pump shaped to better accommodate the transition from the pleural space to the subcutaneous tissue to provide an arbitrary orientation angle of the pump relative to the chest wall and to better prevent displacement that would occur once placed (the inlet and outlet tubes are schematically shown as shortened for illustrative purposes).

[0048] Figure 19 An alternative perspective view of an automated intercostal pump-based fluid management system is shown, which includes a pump shaped to better accommodate the transition from the pleural space to the subcutaneous tissue to provide an arbitrary orientation angle of the pump relative to the chest wall, thereby providing additional features to ensure that the automated intercostal pump-based fluid management system is in place and to better prevent displacement that would occur once in place (the inlet and outlet tubes are schematically shown as shortened for illustrative purposes).

[0049] Figure 20A A perspective view of a fluid management system based on an automatic inter-rib pump is shown. The fluid management system based on an automatic inter-rib pump includes a pump for placement in the inter-rib space and a dome-shaped diaphragm that can be manually actuated to improve the overall function of the pump system.

[0050] Figure 20B It shows Figure 20A A schematic cross-sectional view of the pump in the fluid management system based on an automatic inter-rib pump is shown.

[0051] Figure 21 A perspective view of a fluid management system based on an automatic inter-rib pump is shown. The fluid management system includes a pump housed in the inter-rib space, a dome-shaped diaphragm that can be manually actuated to improve the overall function of the pump system, and an inlet port with a dome-shaped diaphragm that can be punctured to allow access to the interior of the fluid management system based on the automatic inter-rib pump.

[0052] Figure 22 An alternative perspective view of an automatic inter-rib pump-based fluid management system is shown, which includes a pump for placement in the inter-rib space, a rhomboid stabilizing and directional feature, and two inlet ports with dome-shaped diaphragms that can be punctured to allow access to different areas inside the automatic inter-rib pump-based fluid management system.

[0053] Figure 23A A perspective view of a fluid management system based on an electromechanical automatic pump using a piezoelectric diaphragm is shown;

[0054] Figure 23B , Figure 23C and Figure 23D It shows Figure 23A The diagram shows a cross-sectional view of the pump in the fluid management system based on an electromechanical automatic pump.

[0055] Figure 24A A perspective view of a fluid management system based on an automatic inter-rib pump is shown. The fluid management system based on an automatic inter-rib pump includes a pump for placement in the inter-rib space and an electromechanical pump that can be activated to improve the overall function of the pump system.

[0056] Figure 24B It shows Figure 24A A schematic cross-sectional view of the pump in the fluid management system based on an automatic inter-rib pump is shown.

[0057] Figure 25 A fluid management system based on an automated intercostal pump, which is implanted in the patient and connected to an external reservoir, is shown.

[0058] Figure 26A and Figure 26B A method for drawing fluid using a fluid management system based on an automatic inter-branch pump is shown. Detailed Implementation

[0059] The apparatuses, systems, and methods described herein can be used for the purpose of draining and / or moving fluid from one cavity within the human body to another. In particular, the apparatuses, systems, and methods described herein include automatic pumps that provide general pumping functions in automatic pump-based fluid management systems.

[0060] For purposes of explanation, the disclosure herein includes a discussion of the use of an automated pump-based fluid management system for the purpose of draining pleural fluid to treat pleural effusion. However, it should be understood that such an application is merely one specific implementation of an automated pump-based fluid management system, and other implementations and applications are possible.

[0061] Furthermore, for purposes of explanation, the disclosure herein describes automatic pumps as part of a specific 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 specific implementation of an automatic pump-based fluid management system using the automatic pumps described herein, and other uses of the automatic pumps are also possible.

[0062] Fluid management systems based on automatic pumps can provide periodic, continuous, and automated drainage of bodily fluids. Therefore, many drawbacks of other techniques used for fluid drainage can be avoided.

[0063] 1. Fluid Management System Based on Automatic Pumps

[0064] Figure 1 A perspective view of a fluid management system based on an automatic pump is shown. This system includes an automatic pump and inlet and outlet pipes (the lengths of the inlet and outlet pipes are schematically shortened for illustrative purposes). It should be understood that... Figure 1 An implementation of an automatic pump-based fluid management system is shown for illustrative purposes, and other implementations are also possible.

[0065] a. Overview of Fluid Management Systems Based on Automatic Pumps

[0066] Reference Figure 1 An automatic pump-based fluid management system 100 for moving fluid from a first body compartment to a second body compartment includes a pump 110, which typically has an inlet 130 and an outlet 132 and is capable of moving fluid between the inlet 130 and the outlet 132.

[0067] The fluid management system 100 based on the automatic pump also includes a first pipe 120 and a second pipe 122. An inlet 130 and an outlet 132 each communicate between the interior and exterior of the pump 110 and are respectively connected to the first pipe 120 and the second pipe 122. In other words, the inlet 130 and the outlet 132 are configured to provide fluid communication between the first pipe 120 and the interior space of the pump 110, and between the second pipe 122 and the interior space of the pump 110, respectively.

[0068] Furthermore, the first pipe 120 includes a pipe inlet end 150 and a pump inlet end 140. Typically, the first pipe 120 is configured such that, when using an automatic pump-based fluid management system 100, the pipe inlet end 150 can be positioned in the area of ​​the human body from which fluid will be drained. On the other hand, the pump inlet end 140 is connected to the inlet 130 of the pump 110. Therefore, as depicted by the length extension 160, the length of the first pipe 120 can be varied.

[0069] Similarly, the second pipe 122 includes a pump outlet end 142 and a pipe outlet end 152. Typically, the second pipe 122 is configured such that, when using the automatic pump-based fluid management system 100, the pipe outlet end 152 can be positioned in the area of ​​the body to which fluid is to be diverted. On the other hand, the pump outlet end 142 is connected to the outlet 132 of the pump 110. Therefore, as depicted by the length extension 162, the length of the second pipe 122 can be varied.

[0070] Although the first tube 120 and the second tube 122 are shown 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 is desirable for the first tube 120 and the second tube 122 to enter and exit the pump 110 at approximately 90-degree angles, respectively, so that the pump 110 can be positioned in a more advantageous manner. It is also desirable for the first tube 120 and the second tube 122 to enter and exit the pump 110 at other angles.

[0071] Although tubes 120 and 122 are generally shown as flexible tubes that can be easily manipulated and / or shaped to take any form or orientation, in some embodiments, it may be desirable for tubes 120 and 122 to be rigidly or semi-rigidly defined such that the desired shape or orientation of the tube can be maintained. For example, one of the tubes may be constructed, shaped, or cast at least partially rigidly or semi-rigidly such that the tube has a 90-degree bend as it exits the interrib pump 110. Each of tubes 120 and 122 may be constructed with a similar 90-degree bend. Alternatively, the tubes may not have a similar bend. As yet another alternative, the tubes may each have some other degree of bend.

[0072] To achieve fluid movement based on an automatic pump, pump 110 can be an automatic interrib pump, as discussed in more detail below. This pump includes a generally elastic, flexible chamber with a one-way valve at the inlet and an outlet. Pump 110 utilizes rib movement during normal breathing to automatically and cyclically compress and depressurize the elastic, flexible chamber between adjacent ribs, thereby providing a pumping action. Alternatively, as discussed in more detail below, pump 110 can be an electromechanical pump, such as a gear pump, screw pump, rotary vane pump, diaphragm pump, piezoelectric diaphragm pump, plunger pump, peristaltic pump, cam pump, piston pump, or centrifugal pump. Other types of pumps are also possible.

[0073] b. Fluid management system based on pleural and peritoneal automatic pumps

[0074] Reference Figure 2A An automated pump-based fluid management system 100 is shown implanted in a patient 200, providing a means of draining fluid from a first region 220 within the patient's body to a second region 230. In one embodiment, as in Figure 2A In the embodiment depicted, fluid is drained from the patient's pleural cavity to the patient's peritoneal cavity. Therefore, 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.

[0075] In one embodiment, the automatic pump 110 is configured such that it can be placed under the patient's skin, outside the patient's pleural cavity 400. To access the patient's pleural cavity 220, a first tube 120 passes through and traverses the pleural cavity 400 between adjacent ribs from the pump inlet 130, wherein the inlet end 150 of the first tube 120 is located within the pleural cavity 220 from which fluid is drained. A second tube 122 passes through and traverses under the skin along the abdominal wall from the pump outlet 132, wherein the outlet end 152 of the second tube 122 is located within the peritoneal cavity 230 from which fluid is drained. The peritoneal cavity 230 has fluid absorption capacity, such that excess fluid transferred from the pleural cavity 220 is absorbed into, for example, the patient's interstitial tissue, lymphatic vessels, and blood vessels, thereby minimizing fluid accumulation in the peritoneal cavity 230.

[0076] In other implementations, such as Figure 2B As shown, the automatic pump 110 can be configured such that it can be placed within the pleural cavity 220 of a patient. The inlet end 150 of the first tube 120 and the first tube 120 itself can be positioned within the pleural cavity 220, from which fluid will drain. A second tube 122 extends from the pump outlet 132 of the automatic pump 110 located within the pleural cavity 120 into the peritoneal cavity, such that the outlet end 152 of the second tube 122 is positioned within the peritoneal cavity 230, into which fluid will drain. The second tube 122 can traverse the pleural cavity 400 between adjacent ribs, run subcutaneously along the pleural cavity 400 and traverse the abdominal wall, such that the outlet end 152 of the second tube 122 is positioned within the peritoneal cavity 230, into which fluid will drain. Alternatively, the second tube 122 can pass directly from the patient's pleural cavity 220 through the diaphragm 240 into the patient's peritoneal cavity 230.

[0077] In other implementations, such as Figure 2C As shown, the automatic pump 110 and the outlet second tube 230 can be configured to be placed within the patient's peritoneal cavity 230, wherein the first tube passes under the skin along the thoracic cavity 400 from the pump inlet 130 through the abdominal wall and traverses the thoracic cavity 400 between adjacent ribs to enter the pleural cavity 220, such that the inlet end 150 of the first tube 120 is located within 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.

[0078] c. Pleural cavity pressure and peritoneal cavity pressure

[0079] The pressure in the pleural cavity 220 differs from that in the peritoneal cavity 230, is not static, and typically varies during normal breathing. Inhalation is an active process requiring muscle contraction. During inspiration, contraction of the external intercostal muscles causes the ribs and sternum to rise, and the diaphragm contracts, flattens, and presses against the abdominal contents. This combined action results in expansion of the thoracic cavity, accompanied by pleural pressure (P0) that expands the elastic lung. 胸膜 The decrease in peritoneal pressure (P) leads to compression of abdominal contents and increases peritoneal pressure. 腹膜 The exhalation during normal breathing is largely a passive process relying on elastic recoil. During exhalation, the external intercostal muscles and diaphragm simply relax. As the external intercostal muscles relax, the elasticity of the inflated lung causes them to retract to their original position. Simultaneously, the diaphragm relaxes, and the compressed abdominal contents push the diaphragm upward. This combined effect results in a decrease in thoracic cavity size, accompanied by an increase in pleural pressure (P). 胸膜 Increased peritoneal pressure (P) and at the same time 腹膜 )reduce.

[0080] like Figure 3 As seen in the image, during normal resting respiration in patients with little or no pleural effusion, pleural pressure (P0.05) is... 胸膜 The peritoneal pressure varies between approximately +3 cmH2O at the end of expiration and approximately -2 cmH2O at the end of inspiration, and the peritoneal pressure (P...) 腹膜 The pressure varies between approximately +5 cmH2O at the end of expiration and approximately +13 cmH2O at the end of inspiration. Throughout the respiratory cycle, the overall pleural pressure is lower than the peritoneal pressure, with the gradient ranging from approximately -2 cmH2O at the end of expiration to approximately -15 cmH2O at the end of 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-peritoneal pressure gradient vary from patient to patient and are influenced by exertion, coughing, sneezing, deep breathing, body position, chest or abdominal disease, prior chest or abdominal surgery, and the presence of pleural effusion. In fact, the presence of pleural effusion can significantly increase the hydrostatic pressure component of the pleural space pressure, thus changing the pleural pressure from a low or even negative value to a positive value. Indeed, in patients with pleural effusion, when effusion is present, the pleural pressure (P... 胸膜 The pleural pressure (P) can rise to approximately +10 cmH2O to approximately +15 cmH2O, and when the effusion is drained, the ...胸膜 It can decrease to approximately -10 cmH2O to approximately -15 cmH2O. [Feller-Kopman D. Large-volume thoracentesis and the risk of re-expansion pulmonary edema. Ann ThorSurg. 2007; 84:1656-1662]. When the effects of pleural effusion are combined with changes that occur during normal respiration, pleural pressure may be higher than peritoneal pressure during the respiratory cycle, where, in the presence of effusion, the gradient can range from approximately -5 cmH2O to approximately +13 cmH2O.

[0081] For the automatic pump-based fluid management system 100 to transfer fluid from the pleural cavity 220 to the peritoneal cavity 230, the automatic pump 110 can overcome the pressure gradient present 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 effusion or exudate. When the automatic pump-based fluid management system 100 is initially installed and exudate is 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 automatic pump 110 is lower than the pleural and peritoneal pressure gradient.

[0082] like Figure 3As shown, when most of the pleural effusion is drained from the pleural cavity 220, a low pleural-peritoneal pressure gradient exists. Due to this pressure gradient, at the end of expiration, the automatic pump 110 can generate an exhaust pressure of at least about 2 cmH2O to overcome this 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 an exhaust pressure of at least about 15 cmH2O to overcome the pressure gradient between the peritoneal cavity 230 and the pleural cavity 220, and thus is able to pump fluid from the pleural cavity 220 to the peritoneal cavity 230. Note that if the pump generates a constant exhaust pressure, the flow rate between the pleural cavity 220 and the peritoneal cavity 230 will vary during the respiratory cycle due to changes in the 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 an exhaust pressure of at least about 25 cmH2O to overcome changes in pressure gradient that may exist during a complete cycle of normal breathing, and thus be able to pump fluid from the pleural cavity 220 and peritoneal cavity 230 at any point during normal breathing, and the pump can even generate an exhaust pressure of up to about 35 cmH2O to about 50 cmH2O to overcome patient-to-patient variability. Additionally, it can be noted that the automatic pump 110 can be designed to operate preferentially during expiration and ideally during the final portion of expiration when the pressure gradient between the peritoneal cavity 230 and the pleural cavity 220 is low. In this case, the automatic pump 110 may only need to generate a minimum exhaust pressure of about 5 cmH2O, or preferably about 10 cmH2O to about 15 cmH2O, to overcome patient-to-patient variability in pumping fluid from the pleural cavity 220 to the peritoneal cavity 230. Compared to the operation of the automatic pump 110 throughout the entire respiratory cycle, at the beginning of exhalation, or at the end of inhalation, this lower discharge pressure translates to a lower power consumption rate and lower total power for each unit volume of exudate pumped by the automatic pump 110.

[0083] d. Pleural fluid fragments and clotting proteins

[0084] In both health and disease, pleural fluid is essentially a filtrate of blood altered through reabsorption. It is filtered through the vessel walls, interstitial tissue, and the mesothelial cell membranes on the surfaces of the visceral and parietal pleura, and is altered through the reabsorption of fluids, solutes, proteins, and cells. Similar to the interstitial fluid of other organs, in healthy individuals, pleural fluid contains proteins and a small number of cells. The total protein concentration in pleural fluid is approximately 1.0 g / dL (compared to 6.0 g / dL or higher in plasma), with albumin being the most abundant, accounting for about 50% of the total protein; globulins are the second most abundant, accounting for about 35%; and fibrinogen is the third most abundant, accounting for less than 20% of the protein. The cell concentration is approximately 2,000 cells / mm³. 3It is a volumetric pleural fluid, and is mainly composed of mesothelial cells, monocytes and lymphocytes.

[0085] In malignant tumors, this filtration and reabsorption system is out of balance. The cells, membranes, and tissues used to filter blood tend to be less selective, and the reabsorption mechanisms are altered and generally less efficient. Therefore, malignant tumors produce increased pleural fluid volume and abnormal composition, resulting in a fluid rich in proteins and cells, and variations in the types of proteins and cells present. In fact, the total protein concentration in pleural fluid is typically greater than 2.9 g / dL, and the cell concentration can increase many times over.

[0086] Fibrinogen is an important protein in pleural fluid. Fibrinogen is converted into fibrin by thrombin in a process called fibrinogenesis. Fibrin is broken down by plasminogen in a process called fibrinolysis. Plasminogen is then activated by tissue plasminogen activator (tPA), and tPA is inhibited by plasminogen activator inhibitor-1 (PAI-1). The net amount of fibrin produced is a result of the imbalance between fibrinogenesis and fibrinolysis.

[0087] Pleural fluid fibrinogen concentrations are typically lower than plasma concentrations. Even in patients with malignant tumors, pleural fluid fibrinogen concentrations tend to be even lower as total protein concentrations tend to increase, pleural fluid tPA levels tend to increase, and PAI-1 tends to decrease. All of these tend to reduce net fibrin production.

[0088] Nevertheless, an imbalance between fibrinogenesis and fibrinolysis can still occur in patients with malignant pleural effusion, potentially leading to fibrin formation. Fibrin can organize into small clots, chains, membranes, and septa. Fibrin membranes and septa are responsible for the formation of pleural effusion cavities or sacs, which can make drainage of fluid from the pleural space difficult, and fibrin clots and chains can obstruct drainage tubes.

[0089] In fact, the overall anatomical results of malignant pleural effusions as indicated by transpleural ultrasound of the pleural cavity show that 8.7% of patients have complex septate effusions, 15.4% have homogeneous effusions, and 65.4% have complex non-septate effusions, the latter two of which may represent some combination of blood and cells as well as fibrin debris, and only 10.6% of patients have anechoic (clear fluid).

[0090] To prevent blockage or clogging in automatic pump-based fluid management systems and maintain flow through the system, multiple strategies, either individually or in combination, can be employed. One strategy is to provide multiple fluid inlet paths. (See reference...) Figure 4The 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 can prevent obstruction of flow into the first tube 120 or can increase the volume or efficiency of fluid drawn into the first tube 120, and therefore, can increase the volume or efficiency of fluid diverted by the automatic pump-based fluid management system 101. The fluid inlet perforations 170 may also be advantageous by allowing alternative fluid inlet locations in cases where the tube inlet end 150 or other perforations 170 become blocked due to, for example, fibrin clots, fibrin chains or other debris, or because the first tube 120 is against the chest wall or lung. The second tube 122 may also include a fluid outlet perforation 180.

[0091] An additional or alternative strategy is to construct the first pipe 120 to provide a filtration mechanism for allowing fluid to enter the automatic pump-based fluid management system. (See reference...) Figure 5 The first tube 120 may include one or more filter fluid inlet perforations 173. The filter fluid inlet perforations 173 may take the form of holes in the wall of the first tube 120, allowing fluid to be drawn into the first tube 120. The filter fluid inlet perforations 173 are sized and shaped such that any fibrin clots, fibrin chains, or other debris that can pass through the filter perforations 173 can pass through the entire fluid path of the filter-based automatic pump-based fluid management system 102 without obstructing or significantly impeding fluid flow. Alternatively, the filter 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 filter-based automatic pump-based fluid management system 102. Therefore, any fibrin clots, fibrin chains, or other debris that can pass through the filter fluid inlet perforations 173 will be smaller than the smallest opening in the fluid path of the filter-based automatic pump-based fluid management system 102, and should therefore be able to pass through the fluid path of the filter-based automatic pump-based fluid management system 102. Figure 5 As illustrated, the 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 the placement of the first tube 120.

[0092] like Figure 6As shown, in another additional or alternative potential strategy, a fibrinolytic coating 190 is disposed on at least a portion of the first tube 120 exposed to pleural fluid. This fibrinolytic coating 190 can be used to break down fibrin, fibrin clots, fibrin chains, fibrin membranes, fibrin septa, and any other fibrin debris in the fluid, allowing the fluid to pass through a filter-based, automated pump-based fluid management system 102. Examples of fibrinolytic factors used in 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 may be used.

[0093] In another additional or alternative strategy, such as Figure 7 As shown, fibrinogen scavenger 192 is disposed on at least a portion of the first tube 120 exposed to pleural fluid. The fibrinogen scavenger is designed to convert fibrinogen into fibrin and bind the fibrin to the tip of the catheter, preventing fibrin from remaining free in the pleural fluid to enter the fluid pathway of the automated pump-based fluid management system 102. Examples of fibrinogen scavengers include thrombin, factor XIIIa, surface roughness, surface texture, microfibrils, and polyester. Other fibrinogen scavengers or other methods of converting fibrinogen into fibrin may also be used to remove fibrin from the pleural fluid, preventing fibrin from remaining free in the pleural fluid to block the fluid pathway of the automated pump-based fluid management system 102.

[0094] In addition to or alternative strategies to prevent clogging, fluid inlets, fluid outlets, first pipes, second pipes, or any other aspect of an automatic pump-based fluid management system may be coated with anticoagulants or fibrinolytic agents. For example, components or surfaces of pump 110, first pipe 120, or second pipe 122 may be at least partially coated with anticoagulants or fibrinolytic agents. The presence of anticoagulants reduces the amount of clots that would otherwise form if the anticoagulants were not present. Examples of anticoagulant factors include heparin, low molecular weight heparin, fondaparin, edaparin, biotinylated edaparin, dabigatran, rivaroxaban, apixaban, betrixaban, edoxaban, darixaban, letaxaban, erixaban, hirudin, lepirudin, bivalirudin, argatroban, dabigatran, cimetidine, hirudin, vitamin E, coumarin, warfarin, acenitroprusside, phenylpropanol, atromanin, ninhydrin, bromadiolone, and biphenyl causticatine. 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 anticoagulant factors or fibrinolytic agents may be used.

[0095] In another additional or alternative potential strategy, to prevent clogging or to handle clogging when it occurs, the walls of the automatic pump 110 may be constructed using a material that can be pierced by a needle-like object or similar object to allow for the dripping of, for example, anticoagulants, fibrinolytic agents, or other suitable materials into the interior of the automatic pump-based fluid management system 100. Alternatively, and as further described below, an inlet port may be added to the automatic pump 110, which also allows for the dripping of, for example, anticoagulants, fibrinolytic agents, or other suitable materials into the interior of the automatic pump-based fluid management system 100.

[0096] In addition to or alternative strategies to prevent obstruction, patients can be selected based on favorable pleural effusion characteristics, such as those indicated by transthoracic ultrasound of the pleural cavity 220, suggesting a system unlikely to obstruct the flow. For example, the use of an automated pump-based fluid management system may be limited to patients with anechoic (clear fluid) effusions, as indicated by transthoracic ultrasound of the pleural cavity 220. Other pleural effusion characteristics, such as complex septated effusions, homogeneous echogenic effusions, complex non-septated effusions, or combinations thereof, may also be advantageous.

[0097] 2. Fluid Management System Based on Automatic Interbranch Pumps

[0098] Reference Figure 8A A fluid management system 103 based on an automatic interrib pump, positioned between the first and second ribs, includes a pump 111, which is typically a resilient, flexible structure enclosing an internal space and having an inlet 130 and an outlet 132. The automatic interrib 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 cylinder 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 constituent materials provides elasticity and at least one of the constituent materials provides fluid containment. For example, the pump 111 may include a resilient nickel-titanium alloy, steel, polyester, or other resilient 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 pump 111 is typically shown as cylindrical, other configurations are possible. In short, pump 111 can be any shape that provides suitable compression / decompression and is disposed within the interstitial region. In particular, it may be desirable for pump 111 to conform to the characteristics (i.e., shape and / or space) of a specific region to some extent. In embodiments, pump 111 may comprise a flexible silicone tube. However, pump 111 may also take other forms.

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

[0101] The first tube 120 includes a tube inlet end 150 and a pump inlet end 140. Typically, the first tube 120 is configured such that, when using a fluid management system 103 based on an automatic intercostal pump, the tube inlet end 150 can be positioned in the area of ​​the human body from which fluid will be drained. On the other hand, the pump inlet end 140 is connected to the inlet 130 of the intercostal pump 111. Therefore, as depicted by the length extension 160, the length of the first tube 120 can be varied.

[0102] Similarly, the second tube 122 includes a pump outlet end 142 and a tube outlet end 152. Typically, the second tube 122 is configured such that, when using the fluid management system 103 based on an automatic intercostal pump, the tube outlet end 152 can be positioned in the area of ​​the body to which fluid is directed. On the other hand, the pump outlet end 142 is connected to the outlet 132 of the intercostal pump 111. Therefore, as depicted by the length extension 162, the length of the second tube 122 can be varied.

[0103] Although the first tube 120 and the second tube 122 are shown entering the interrib 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 interrib pump 111 at any desired angle. For example, it is desirable for the first tube 120 and the second tube 122 to enter and exit the interrib pump 111 at approximately 90-degree angles, respectively, so that the interrib pump 111 can be positioned more advantageously in the interrib region. It is also desirable for the first tube 120 and the second tube 122 to enter and exit the interrib 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 to take any form or orientation, in some embodiments, it may be desirable for tubes 120 and 122 to be rigidly or semi-rigidly defined such that the desired shape or orientation of the tube can be maintained. For example, one of the tubes may be at least partially rigidly or semi-rigidly constructed, shaped, or cast such that the tube has a 90-degree bend as it exits the interrib pump 111. Each of tubes 120 and 122 may be constructed with a similar 90-degree bend. Alternatively, the tubes may not have a similar bend. As yet another alternative, the tubes may each have some other degree of bend.

[0105] Reference Figure 8A 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 surface of the first tube 120 to allow 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 can increase the volume or efficiency of fluid drawn into the first tube 120, and therefore, can increase the volume or efficiency of fluid drained by the intercostal pump-based fluid management system 103. The fluid inlet perforations 170 may be particularly advantageous in cases where the tube inlet end 150 or other perforations become obstructed due to, for example, fibrin clots, fibrin chains or other debris, or because the first tube 120 is against the chest wall or lung, because they allow for alternative fluid inlet locations. The second tube 122 may also include a fluid outlet perforation 180.

[0106] Reference Figure 8B As illustrated in the insertion cross-section C, the first tube 120 may include one or more linear fluid channels 175. A linear fluid inlet slit 174 in the surface of the first tube 120 leads to the linear fluid channel 175, thereby allowing fluid to be drawn into the linear fluid channel 175 of the first tube 120. Combined, these features provide redundancy to prevent the first tube 120 from becoming blocked. The linear fluid inlet slit 174 may be particularly advantageous if it allows access to the interior of the first tube 120 along a substantial length, such that if a single slit or a portion of the slits becomes blocked due to, for example, fibrin clots, fibrin chains or other debris, or if the first tube 120 is against the chest wall or lung, the first tube 120 may still generally allow fluid to enter the interior of the first tube 120 and continue along its length. Furthermore, the linear fluid inlet slit 174 may be sized to limit the size of particles or debris entering the linear fluid channel 175. This size can be selected to prevent particles or debris from entering that are large enough to block the lumen of the linear fluid channel 175 or any other narrow section within the fluid management system 103 based on the automatic intercostal pump.

[0107] about Figure 8A and Figure 8B The described fluid management system 103 based on an automatic interbranch pump may additionally or alternatively include information regarding... Figures 4 to 7 Any other features, materials, or properties described in the automatic pump-based fluid management system.

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

[0109] Reference Figure 9A fluid management system 103 based on an automated intercostal pump is shown implanted in a patient 200, providing a means of draining fluid from a first region 220 within the patient's body to a second region 230. In one embodiment, as in Figure 9 In the embodiment depicted, fluid is drained from the patient's pleural cavity to the patient's peritoneal cavity. Therefore, 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 this embodiment, the automatic intercostal pump 111 is configured such that it can be at least partially positioned in 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 it. Therefore, a first tube 120 and a corresponding pump inlet 130 are positioned inside the patient's thoracic cavity. A second tube 122 and a corresponding pump outlet 132 are positioned outside the patient's thoracic cavity. Thus, during breathing and corresponding compression / decompression of the thoracic cavity, the patient 210 will automatically operate the intercostal pump 111 (e.g., the "pump"). The operation of the intercostal pump 111 is further discussed below.

[0111] 4. Automatic interrib pump

[0112] a. Automatic intercostal pump design

[0113] Figure 10A A cross-sectional schematic diagram of an automatic inter-rib pump 111 in a generally or substantially uncompressed state is shown, wherein both the one-way inlet valve 320 and the one-way outlet valve 322 (described in further detail below) are closed. As described above, the automatic inter-rib pump 111 can typically be an elastic, flexible tube or cylinder made of polyurethane, silicone, polyvinyl chloride, latex rubber, or other suitable elastic material. Alternatively, the pump 111 can be made of a combination of two or more materials, wherein at least one of the materials provides elasticity and at least one of the constituent materials provides fluid containment. For example, the pump 111 may include a first elastic component such as an elastic nickel-titanium alloy, steel, polyester, or other elastic 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 inter-rib pump 111. Other materials may be used.

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

[0115] Typically, the pump wall 310 (312) can be made of any material and of any thickness suitable for achieving the desired flexibility and elasticity of the interrib pump 111. The specific thickness of the pump wall 310 (312) in a given embodiment may depend, for example, on the material of the pump wall 310 (312) and the intended use of the interrib pump 111 (e.g., drainage function). In some embodiments, the pump wall 310 (312) may be made of silicone resin, wherein the hardness of an ASTM D2240 Type A hardness tester is in the range of about 30 to about 70 (Young's modulus between about 1.15 MPa and about 5.5 MPa), preferably between about 40 and about 60 (Young's modulus between about 1.7 MPa and about 3.6 MPa), and more preferably between about 45 and about 50 (Young's modulus between about 2.0 MPa and about 2.5 MPa). In some embodiments, the interrib pump 111 may comprise a generally or generally cylindrical silicone resin structure having a generally circular cross-section. The generally cylindrical silicone structure has an inner diameter that can be 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 that is 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 one embodiment, the generally cylindrical structure may have an inner diameter of about 6.4 mm and an outer diameter of about 8 mm, wherein the corresponding wall thickness is about 0.8 mm. In other embodiments, the interrib pump 111 may comprise a silicone structure having a generally elliptical cross-section or a generally rectangular cross-section. Other shapes and sizes are also desirable.

[0116] The inter-rib pump 111 also includes a one-way inlet valve 320 and a one-way outlet valve 322. The inlet valve 320 may be located in the internal space 330 of the pump body, generally near the inlet 130. The one-way inlet valve 320 may be any suitable one-way valve and may be made, for example, of silicone or other suitable materials. The one-way inlet valve 320 is configured to prevent or substantially prevent fluid movement from the internal space 330 of the inter-rib pump 111 to the inlet 130. Simultaneously, the one-way inlet valve 320 is configured to allow fluid movement from the inlet 130 to the internal space 330 of the inter-rib 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 internal space 330 of the inter-rib pump 111.

[0117] Correspondingly, the one-way outlet valve 322 may be located in the internal space 330 of the pump body, typically near the outlet 132. The one-way outlet valve 322 can be any suitable one-way valve and may be made, for example, of silicone or other suitable materials. The one-way outlet valve 322 is configured to allow fluid to move from the internal space 330 of the inter-rib pump 111 to the outlet 132. Simultaneously, the one-way outlet valve 322 is configured to prevent or substantially prevent fluid movement from the outlet 132 to the internal space 330 of the inter-rib pump 111. In other words, the one-way outlet valve 322 is in fluid communication with the outlet 132 to provide unidirectional fluid movement from the internal space 330 of the inter-rib pump 111 to the outlet 132.

[0118] In the embodiment of the inter-rib pump 111, a one-way inlet valve frame 340 and a one-way outlet valve frame 342 are respectively added to the outer periphery of the one-way inlet valve 320 and the outer periphery of the one-way outlet valve 322, such that compression / decompression of the inter-rib 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 freely constructed of any relatively rigid or non-flexible material, respectively, for the outer periphery of the one-way inlet valve 320 and the outer periphery of the one-way outlet valve 322. 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 the lower wall 312 of the inter-rib pump 111, and between the second tube 122 and the upper wall 310 and the lower wall 312 of the inter-rib pump 111. Other types of valve frames may be used, which can function to ensure that the compression / decompression of the inter-rib 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.

[0119] It should be noted that although the one-way inlet valve 320 and the one-way outlet valve 322 are depicted as being located within the internal space 330 of the inter-rib pump 111, alternative arrangements of the valves may also be desired. For example, one or both of the one-way inlet valve 320 and the one-way outlet valve 322 may be located outside the pump body, possibly 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 arrangement of the valves is not necessarily critical, as long as these valves adequately provide a large volume of one-way fluid flow into and out of the inter-rib pump 111.

[0120] b. Pump operation

[0121] Figure 10BA schematic cross-sectional view of the inter-rib pump 111 in a generally or substantially compressed state is shown. As illustrated, in an embodiment, 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 causes the one-way outlet valve 322 to open, and fluid located in the interior space 330 flows from the interior space 330 through the one-way outlet valve 322 and into the second pipe 122. For incompressible fluids, the volume change experienced by the internal 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 moving from the internal space 330 through the one-way outlet valve 322. As fluid moves from the internal space 330 through the one-way outlet valve 322, the pressure in the internal space will decrease. Figure 10C As shown, once the internal pressure is approximately equal to or roughly equal to the pressure in pump outlet 132, the flow will stop and the one-way outlet valve 322 will close.

[0122] As described above, the interrib pump 111 is generally elastic and flexible, and therefore, in situations such as Figure 10B and Figure 10C After being placed in a compressed state, as shown, when at least one of the first force 350 and the second force 352 is removed, the interrib pump 111 will return to the state as shown. Figure 10D The uncompressed state is shown in the diagram. 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 internal space 330 increases and the pressure in the internal space 330 decreases. The pressure inside the internal space 330 eventually drops below the pressure inside the inlet, causing the one-way inlet valve 320 to open and fluid in the inlet to flow into the internal space 330. In this way, the inter-rib pump 111 operates as a pump, which typically draws fluid from the pump inlet 130 and delivers the fluid to the pump outlet 132.

[0123] In addition, such as Figure 10E and Figure 10F As shown, the interrib pump 111 can be configured to have a reinforcing member 333 that is coupled to or attached to the wall, such that when at least one of the first force 350 and the second force 352 is applied, it is as follows: Figure 10A and Figure 10BCompared to the volume change in the internal space 330 without the reinforcing member 333, a larger volume change can be produced in the internal space 330. This occurs because the reinforcing member 333 applies a relatively narrow distribution of the first force 350 and the second force 352 along a longer length of the pump's upper wall 310 and lower wall 312, resulting in a larger change in the pump's internal volume 330. Although the reinforcing member 333 is shown located in the middle of the length along the upper wall 310 and lower wall 312, such that both ends of the reinforcing member 333 move together, the reinforcing 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 reinforcing member now acts as a lever arm, providing an even larger volume change for the internal space 330 when at least one of the first force 350 and the second force 352 is applied. The reinforcing member 333 can generally be any suitable size and shape and can be made of any suitable material, and in some cases can be made of any suitable material that is generally more rigid than the material forming the upper wall 310 and the lower wall 312.

[0124] During use, the intercostal pump 111 may be compressed due to the patient's breathing. More specifically, the intercostal pump 111 may be compressed due to the natural movement of the patient's ribs during the respiratory cycle. Furthermore, the intercostal pump 111 may be arranged such that the internal space 330 passes between the fibers of the external or internal intercostal muscles and can be compressed due to the contraction of these muscle fibers.

[0125] like Figure 11A As shown, 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 anatomically first and second ribs, but can be either anatomically first or second ribs. When the thoracic cavity expands (during inspiration), the individual ribs 410, 412, 414, and 416 separate, and in this configuration of the ribs, a relatively small force is applied to the intercostal pump 111. Therefore, the intercostal pump 111 is in a substantially uncompressed state.

[0126] like Figure 11B As shown, when the thoracic cavity contracts (during exhalation), the individual ribs 410, 412, 414, and 416 move toward each other. As a result, a first force 350 and / or a second force 352 are applied to the intercostal pump 110 via the first rib 412 and / or the second rib 414, respectively. Therefore, the intercostal pump 110 is in a generally or substantially compressed state.

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

[0128] In a typical adult, the relative movement between the first rib 412 and the second rib 414 throughout the respiratory cycle is approximately 0.25 mm to 3 mm. Therefore, the wall of the intercostal pump 111 can be compressed by 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, it may vary depending on the specific anatomy of the first rib 412 and the second rib 414, as well as their specific position relative to the spine and / or sternum along their length.

[0129] The relevant consideration is that the ribs are filled with soft tissue. Soft tissue itself can be compressible, and therefore, if any soft tissue remains at the location between the intercostal pump 111 and either the first rib 412 or the second rib 414, the full extent of possible compressibility of the intercostal pump 111 may be affected. 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 can themselves be relatively compressible. Therefore, in some cases, it may be desirable to position the intercostal pump 111 in order to contact the portions of the first rib 412 and the second rib 414 that exhibit a relatively small amount of cartilage (i.e., the portions of the ribs with a relatively large amount of exposed bone, in contrast to cartilage).

[0131] Another related consideration is that the intercostal pump 111 can be positioned in such a way 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 way, the intercostal pump 111 can withstand a greater amount of compression. Therefore, it is desirable to position the intercostal pump 111 in a manner substantially parallel to the first rib 412 and the second rib 414, or in relation to... Figure 11A and Figure 11B Instead of the generally vertical orientation usually indicated, it is positioned at any angle between the first rib 412 and the second rib 414, which is generally perpendicular to the first rib 412 and the second rib 414 and generally parallel to the first rib 412 and the second rib 414.

[0132] Another related consideration is that the intercostal pump 111 can be sized relative to the distance between the first rib 412 and the second rib 414 at the end of 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 respiration can be translated into a larger volume change within the intercostal pump 111.

[0133] Another related consideration is that the intercostal pump 111 can be positioned relative to the first rib 412 and the second rib 414 such that the intercostal pump 111 can be periodically deformed during respiration by the relative movement of the first rib 412, the second rib 414, the chest wall and / or other tissues of the lung, such that the volume of the internal space 330 of the intercostal pump 111 changes periodically with respiration, thereby causing fluid to be pumped.

[0134] c. Valve Construction

[0135] Figure 12 Cross-sectional views of a one-way inlet valve in both closed and open states, and a one-way outlet valve in both closed and open states, are shown. In panel A, the one-way inlet valve 320 is shown in the 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 the open state. The size and shape of the one-way inlet valve frame 340 may be selected to provide a connection point to the first pipe 120 or an interconnectable connection. In panel C, the one-way outlet valve 322 is shown in the 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 the open state. The size and shape of the one-way inlet valve frame 342 may be selected to provide a connection point to the first pipe 122 or an interconnectable connection.

[0136] For the one-way inlet valve 320, when the one-way inlet valve 320 is in such a state... Figure 12 When the valve is in the closed position as shown in panel A, the pressure difference across the valve makes pressure P1 ≤ P2 + P c Where P1 and P2 are the pressures at the positions shown in panel A, and P c This is the valve's opening pressure. Similarly, when the one-way inlet valve 320 is in such a state... Figure 12 When the valve is in the open position as shown in panel B, the pressure difference across the valve makes pressure P1 > P2 + P c Where P1 and P2 are the pressures at the positions shown in panel B, and P c Next is the valve's opening pressure.

[0137] For the one-way outlet valve 322, when the one-way outlet valve 322 is in the following position... Figure 12 When the valve is in the closed position as shown in panel C, the pressure difference across the valve makes pressure P2 ≤ P3 + P c Where P2 and P3 are the pressures at the positions shown in panel C, and P c This is the valve's opening pressure. Similarly, when the one-way outlet valve 322 is in such a state... Figure 12 When the valve is in the open position as shown in panel D, the pressure difference across the valve makes pressure P2 > P3 + P c Where P2 and P3 are the pressures at the positions shown in panel D, and P c Next is the valve's opening pressure.

[0138] In one embodiment, the one-way inlet valve 320 and the one-way outlet valve 322 are formed as duckbill valves, which have a thin and generally flat lip that defines a slit that can move from a closed position to an open position. In another embodiment, the one-way inlet valve 320 and the one-way outlet valve 322 may have a low opening pressure P. c This allows the valve to transition from the closed to the open state with a relatively small pressure difference across the valve. The opening pressure P c The reseal pressure can be less than about 25 cmH2O for operation by 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 can have low reseal pressures, allowing the valves to transition from an open to a closed state with a small pressure differential across the valves. This reseal pressure can be less than about 15 cmH2O for operation by 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 the embodiment, the one-way inlet valve 320 and the one-way outlet valve 322 are configured to undergo minimal deformation when closed, and the pressure gradient exists on the valves in the opposite direction to the one-way direction of the one-way inlet valve 320 and the one-way outlet valve 322. Specifically, when back pressure exists on the valves, i.e., when P1≤P2+P c At this time, the one-way inlet valve undergoes minimal deformation, and when back pressure exists on the valve, i.e., when P2 ≤ P3 + P cAt this time, the one-way outlet valve undergoes minimal deformation. Through this design, the volumetric changes generated within the internal space 330 of the pump body are roughly or substantially translated one-to-one into forward flow through the automatic intercostal pump 111. This resistance to deformation can be assessed as the volumetric backflow generated when back pressure is applied to the sealed or closed one-way inlet valve 320 and one-way outlet valve 322. With an applied back pressure of 50 cmH2O or less, the backflow may be less than about 200 μL for operation on most patients, preferably less than about 100 μL, more preferably less than about 50 μL, or even less than about 25 μL. Therefore, the volume pumped forward per cycle (V1) 向前 The volume change (ΔV) of the pump's internal space 330 will be approximately equal to, roughly equal to, or equal to the change in volume of the pump's internal space 330. 内部空间 Subtract the valve volume deformation (V) required to reseal the valve. 重新密封体积 It is generally expressed in another way:

[0140] V 向前 =ΔV 内部空间 -V 重新密封体积

[0141] Non-limiting examples of valves that can be used for check valves 320 and 322 are 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 incorporated herein by reference.

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

[0143] Figures 1 to 7 Any aspect, feature, characteristic, etc., or combination thereof of the automatic pump-based fluid management system described herein can also be incorporated into Figures 8 to 9. Figure 12 In an automatic inter-branch pump-based fluid management system, as an example, to prevent blockage or clogging of the automatic inter-branch pump-based fluid management system and to maintain flow through the system, the first pipe 120 can be configured to provide a filtration mechanism for the fluid entering the automatic inter-branch pump-based fluid management system 104. (See reference...) Figure 13The first tube 120 may include one or more filter fluid inlet perforations 173. The filter 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 filter fluid inlet perforations 173 are sized and shaped such that any fibrin clots, fibrin chains, or other debris that can pass through the filter perforations 173 can also pass through the entire fluid path of the filter-based automatic inter-branch pump-based fluid management system 104 without obstructing or significantly impeding fluid flow. Alternatively, the filter 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 filter-based automatic inter-branch pump-based fluid management system 104. For example, the filter fluid inlet perforations 173 may be sized and shaped such that the filter 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 chains, or other debris that can pass through the filter fluid inlet perforation 173 will be smaller than the minimum opening in the fluid path of the filter-based automatic pump-driven fluid management system 104, and should therefore be able to pass through the fluid path of the filter-based automatic pump-driven fluid management system 102. Figure 13 As illustrated, the inlet end of the first tube 120 may include a closed end, and in some cases may be rounded or smooth to aid in the placement of the first tube 120.

[0144] Setting the stable position and orientation of the interrib pump 111 in the interrib space between the first and second ribs of the pump can be beneficial. (Refer to...) Figure 14A The stabilizing and directional feature 200 is provided on the inter-rib pump and, in some cases, such as near the outlet portion of the inter-rib pump 111, is positioned around the inter-rib pump. Figure 14A The stabilizing and directional features are shown as relatively circular, typically tapered features with a relatively planar surface 201, which is annular or partially annular relative to the body of the inter-rib pump 111 and oriented at a suitable angle 203 with respect to the long axis of the inter-rib pump 111. In use, as... Figure 14B As shown, 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 oriented feature 200 contacts the first rib 414 and the second rib 416, as well as any soft tissue in between, to orient the intercostal pump 111 relative to the chest wall at a desired angle, typically determined by angle 203, and to provide stability at that angle and to prevent movement of the intercostal pump relative to the chest wall along its axis. Although typically shown as circular and conical, the overall shape of the stabilizing and oriented feature 200 can be any shape primarily used to orient the intercostal pump 111 relative to the chest wall and / or to provide stability of the directional and / or axial position of the intercostal pump 111 relative to the chest wall.

[0145] To better accommodate the transition between the pleural cavity and this subcutaneous tissue, located between the skin and the pleural cavity, another implementation method can be constructed. For example... Figure 15A As shown, the fluid management system 105 based on a fitted automatic intercostal pump includes a fitted pump 112, which 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 may be shaped to have angled portions or transition portions that provide an angled transition of about 1 degree to 179 degrees, preferably between about 45 degrees and 135 degrees, more preferably between about 75 degrees and 105 degrees, and in some cases about 90 degrees, for the pump 112 (e.g., between portion 112' and portion 112” as described below). When placed in a patient, the intercostal portion 112' of the fitted pump 112 is placed in the intercostal space between the first and second ribs, and the subcutaneous portion 112” of the pump 112 is placed in the subcutaneous tissue under the skin and on the outer portion of the pleural cavity. In this configuration and placement, for example, as per [reference to...] Figure 11A and Figure 11B As described, when a patient breathes, the intercostal portion 112' of pump 112 is circumferentially compressed and decompressed by the first and second ribs, thereby automatically providing continuous pumping action and fluid flow from the pleural cavity to the peritoneal cavity. Furthermore, in this configuration and placement, the subcutaneous portion 112' of pump 112 is located externally to the pleural cavity and is available for circumferential (or non-circumferential) manual compression between the skin and the pleural cavity, which can provide additional pumping action from pump 112 to supplement the fluid flow from the pleural cavity to the peritoneal cavity when needed. Figure 15B A schematic cross-sectional view of pump 112 of a fluid management system 105 based on a modular automatic inter-branch pump is shown.

[0146] A better alternative for accommodating the transition between the pleural cavity and the subcutaneous tissue of the chest wall, and providing stable positioning. Figure 16AAs shown in the diagram. 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 placed in a patient's body, the intercostal pump 113 is placed in the intercostal space between the first and second ribs, and the transition chamber 701 of the fluid management system 106 based on the transitional automatic intercostal pump is placed in the subcutaneous tissue under the skin and on the outer portion of the pleural cavity. In this configuration and placement, for example, as per [reference to...] Figure 11A and Figure 11B As described, when a patient breathes, the intercostal pump 113 is cyclically compressed and decompressed by the first and second ribs, thereby automatically providing continuous pumping action and fluid flow from the pleural cavity to the peritoneal cavity. Furthermore, in this configuration and placement, the transition chamber 701 is located laterally on the pleural cavity and provides a transition of approximately 90 degrees (or other suitable angle) 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 stable contact between the transition chamber 701 and the pleural cavity and helps maintain the stable positioning of the intercostal pump 113 in the intercostal space between the first and second ribs. Although the transition chamber 701 is shown as a cylindrical member with flat ends, it can take any suitable shape to provide a transition of up to 90 degrees (or other suitable angle) from the pump inlet end 140 of the first tube 120 to the pump outlet end 142 of the second tube 122, as well as stability of the inter-rib pump. The transition chamber 701 can be made of any relatively rigid or non-flexible material, such as nylon, acrylic, polycarbonate, polyetheretherketone resin, acrylonitrile-butadiene-styrene copolymer, polyethylene terephthalate, stainless steel, or other suitable materials. However, the transition chamber 701 can also be made of a relatively more flexible material if desired. Figure 16B A schematic cross-sectional view of pump 113 and transition chamber 701 of fluid management system 106 based on transitional automatic inter-branch pump is shown.

[0147] Another solution for better adaptation to the transition between the pleural cavity and subcutaneous tissue and for providing stable positioning. Figure 17As shown in the diagram. In this embodiment, the transition chamber 701 is a circular, rhomboid-shaped feature configured to engage with and be able to engage with the thoracic cavity, and to help maintain the 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 this case, the transition chamber 701 provides a transition of approximately 90 degrees (or other suitable angle) from the pump inlet end 140 of the first tube 120 to the pump outlet end 142 of the second tube 122, and the stability of the intercostal pump. Although Figure 17 The approximately 90-degree transition shown is likely desirable, but alternative transition angles are also possible, and one such alternative is... Figure 18 As shown in the image. Furthermore, as from... Figure 19 The overall shape of the transition chamber 701, as illustrated by the example mushroom-shaped flange, can vary. Additional stabilizing features, such as a hole 191 located within the transition chamber, can be provided to allow tissue to grow inward or allow sutures to pass through, thereby securing the fluid management system 106 based on the transitional automatic intercostal pump in place. In such a case, the flange portion of the mushroom shape, or at least a portion thereof, can be configured such that the hole 191 in the flange portion does not pierce the internal space 330.

[0148] e. Automatic intercostal pump with manual assistance unit for the pleura and peritoneum

[0149] Another automated intercostal pump adapts to the transition between the pleural cavity and subcutaneous tissue and provides manual assistance for the pumping action. Figure 20AAs shown in the figure. A fluid management system 107 based on a transitional automatic intercostal pump with a manual auxiliary section 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 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. In this embodiment, the body of the transition chamber 702 and the flat first end 710 can be made of any relatively hard or non-flexible material, such as nylon, acrylic, polycarbonate, polyetheretherketone resin, acrylonitrile-butadiene-styrene copolymer, polyethylene terephthalate, stainless steel, or other suitable materials, and the dome-shaped second end 712 can be made of polyurethane, silicone, polyvinyl chloride, latex rubber, or other deformable but recoverable elastic material to its initial shape. When placed in a patient, the intercostal pump 113 is placed in the intercostal space between the first and second ribs, and the transition chamber 702 is placed in the subcutaneous tissue under the skin and on the outer portion of the thoracic cavity. In this configuration and placement, for example, as per [reference to...] Figure 11A and Figure 11B As described, when a patient breathes, the intercostal pump 113 is cyclically compressed and decompressed by the first and second ribs, thereby automatically providing continuous pumping action and fluid flow from the pleural cavity to the peritoneal cavity. Furthermore, in this configuration and placement, the transition chamber 702 is located lateral to 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 stable contact between the transition chamber 702 and the pleural cavity, and 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 supplemental fluid flow from the pleural cavity to the peritoneal cavity is required. Furthermore, if the material used to manufacture the resilient, dome-shaped end 712 of the transition chamber 702 is self-sealing after puncture, fluid can be aspirated or anticoagulants, fibrinolytic agents, and / or other drugs can be dripped into the interior 330 of the fluid management system 107 with a manual assistance section by, for example, by passing a needle through the resilient and self-sealing material of the dome-shaped end 712. Although the body and flat first end of the transition chamber 702 can be made of any relatively hard or non-flexible material, the body and flat first end of the transition chamber 702 can also be additionally or alternatively made of a more flexible material as needed. Figure 20BA schematic cross-sectional view of pump 113 and transition chamber 702 of fluid management system 107 based on transitional automatic inter-branch pump is shown.

[0150] f. Automatic intercostal pump with access port for the thoracoperitoneum

[0151] Another automated intercostal pump 721 adapts to the transition between the pleural cavity and subcutaneous tissue and provides an auxiliary access port. Figure 20A As shown in the diagram, a fluid management system based on a transitional automatic intercostal pump, having 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 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. 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 also 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 part of the auxiliary inlet port 721 can be made of any relatively hard or non-flexible material, such as nylon, acrylic, polycarbonate, polyetheretherketone resin, acrylonitrile-butadiene-styrene copolymer, polyethylene terephthalate, stainless steel, or other suitable materials. The dome-shaped second end 712 of the transition chamber 702 can be made of polyurethane, silicone, polyvinyl chloride, latex rubber, or other suitable elastic materials that can deform and return to their initial shape. The dome-shaped diaphragm 722 of the auxiliary inlet port 721 can be made of certain types of polyurethane, silicone, latex rubber, or other suitable self-sealing materials that can be sharply punctured for entry but can seal the perforation. When placed in a patient, the intercostal pump 113 is placed in the intercostal space between the first and second ribs, and the transition chamber 702 is placed in the subcutaneous tissue under the skin and on the outer part of the thoracic cavity. In this configuration and arrangement, for example, as regarding Figure 11A and Figure 11BAs described, when a patient breathes, the intercostal pump 113 is cyclically compressed and decompressed by the first and second ribs, thereby automatically providing continuous pumping action and fluid flow from the pleural cavity to the peritoneal cavity. Furthermore, in this configuration and placement, the transition chamber 702 is located lateral to 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 stable contact between the transition chamber 702 and the pleural cavity, and 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 supplemental fluid flow from the pleural cavity to the peritoneal cavity is required. Furthermore, the self-sealing dome-shaped diaphragm 722 of the auxiliary entry chamber 721 can be inserted under the patient's skin by puncturing it with a needle, thereby connecting to the internal 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, in order to sample the contents of the internal space 330 or to infuse anticoagulants, fibrinolytic agents and / or other medications into the internal space 330 of the transition chamber 702. It should be noted that during sampling from the internal space 330, a negative pressure may be generated during the sampling process, 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 infusion of anticoagulants, fibrinolytic agents, and / or other medications into the internal space 330, a positive pressure may be generated during the infusion 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 enabling the delivery of anticoagulants, fibrinolytic agents, and / or other medications into the contents of the interior of the second tube 122. Although the body and flat first end of the transition chamber 702 can be made of any relatively rigid or non-flexible material, the body and flat first end of the transition chamber 702 can also be additionally or alternatively made of a more flexible material as needed.

[0152] By providing multiple inlet ports, this concept can be further adopted, allowing access to the interior of a fluid management system based on a transitional automatic inter-branch pump, with inlet port 107', using an auxiliary inlet port. For example... Figure 22As seen in the diagram, for example, the transition chamber 701 is a circular, rhomboid, or other suitably shaped feature that engages with the thoracic cavity and thus helps maintain the 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. There is a first auxiliary inlet chamber 721' with 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 721' with 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 (Not visible in the middle). Therefore, fluid can be sampled by passing through the covered skin and then through the first self-sealing dome-shaped diaphragm 722' of the first auxiliary entry chamber 721', or anticoagulants, fibrinolytic agents, and / or other drugs can be selectively infused into the interior space 330 of the transition chamber 702. Similarly, fluid can be selectively sampled by passing through the covered skin and then through the second self-sealing dome-shaped diaphragm 722' of the second auxiliary entry chamber, or anticoagulants, fibrinolytic agents, and / or other drugs can be infused into the interior of the pump inlet end 140 of the first tube 120.

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

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

[0155] Furthermore, the first tube 120 may include a plurality of perforations or openings 170 that allow fluid to enter the first tube 120 and the pump inlet end 140. Typically, the first tube 120 is configured such that, during use, the perforations 170 can be located in areas of the human body from which fluid will drain. On the other hand, the pump inlet end 140 is coupled to the inlet 130 of the pump 118. The length of the first tube 120 may vary as depicted in the length extension 160.

[0156] Similarly, the second pipe 122 includes a pump outlet end 142 and a pipe outlet end 152. Typically, the second pipe 122 is configured such that, when using an automatic pump-based fluid management system 108, the pipe outlet end 152 can be positioned in the area of ​​the body to which fluid is directed. On the other hand, the pump outlet end 142 is connected to the outlet 132 of the pump 118. The length of the second pipe 122 can be varied, as depicted in the length extension 162.

[0157] Figure 23B A cross-sectional schematic diagram of a fluid management system 108 based on an electromechanical automatic pump is shown in its inactive state with both the one-way inlet valve 320 and the one-way outlet valve 322 closed. The electromechanical pump 118 includes a pump wall that encloses an internal space 330 with the one-way inlet valve 320 and the one-way outlet valve 322.

[0158] The inlet valve 320 may be located within the internal space 330 of the pump body, typically near the inlet 130. The one-way inlet valve 320 may be any suitable one-way valve, such as any one-way valve described herein, and may be made, for example, of silicone. The one-way inlet valve 320 is configured to prevent fluid from moving from the internal space 330 of the pump 118 to the inlet 130. Simultaneously, the one-way inlet valve 320 is configured to allow fluid to move from the inlet 130 to the internal 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 typically provide unidirectional fluid movement from the inlet 130 to the internal space 330 of the electromechanical pump 118.

[0159] Correspondingly, the one-way outlet valve 322 may be located in the internal space 330 of the pump body, typically near the outlet 132. The one-way outlet valve 322 may be any suitable one-way valve, such as any one-way valve described herein, and may be made, for example, of silicone. The one-way outlet valve 322 is configured to allow fluid to move from the internal space 330 of the electromechanical pump 118 to the outlet 132. Simultaneously, the one-way outlet valve 322 is configured to block or substantially block fluid movement from the outlet 132 to the internal 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 typically provide one-way fluid movement from the internal space 330 of the electromechanical pump 118 to the outlet 132.

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

[0161] It should be noted that although the one-way inlet valve 320 and the one-way outlet valve 322 are depicted as being located within the internal space 330 of the interfin pump 118, alternative arrangements of the valves are also expected. For example, one or both of the one-way inlet valve 320 and the one-way outlet valve 322 may be located outside the pump body, may be located within the inlet pipe 120 and the outlet pipe 122 respectively, or may be located between the inlet pipe 120 and the pump body or between the outlet pipe 122 and the pump body respectively. The specific arrangement of the valves is not necessarily critical, as long as the valves adequately provide a large volume of one-way fluid flow into and out of the interfin pump 111.

[0162] In the electromechanical pump 118, a liquid-impermeable membrane 550 separates an interior 330, which is in fluid communication with a one-way inlet valve 320 and a one-way outlet valve 322, from a compartment containing a battery 510, a controller 530, and an electromechanical actuator 540. In the electromechanical pump 118, the electromechanical actuator 540 may be a piezoelectric diaphragm connected to the membrane 550, enabled and disabled 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, the piezoelectric diaphragm 540 is in the disabled state, and both the one-way inlet valve 320 and the one-way outlet valve 322 are closed. Figure 23C As shown, 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 impact the interior 330 of the electromechanical pump 118. This reduces the volume available for fluid within the interior 330, increases the pressure within the interior 330, and opens the one-way outlet valve 322, allowing fluid to move from the interior 330 of the electromechanical pump 118 to the pump outlet end 142 of the second pipe 122 and ultimately to the pipe outlet end 152 of the second pipe 122. Figure 23D As shown, when the controller 530 deactivates the piezoelectric diaphragm 540, the piezoelectric diaphragm 540 returns to its initial shape, and the membrane 550 also returns to its initial shape. This increases the volume available for fluid within the interior 330 of the electromechanical pump 118 and reduces the pressure within the interior 330, thereby closing the one-way outlet valve 322 and opening the one-way inlet valve 320, allowing fluid to move from the interior of the pump inlet end 140 of the first pipe 120 into the interior 330 of the electromechanical pump 118. In this way, the cyclic activation and deactivation of the piezoelectric diaphragm 540 results in fluid being pumped.

[0163] In specific cases of recurrent malignant pleural effusion requiring treatment to control symptoms, 25% of patients will die at the end of a 12-week period of daily drainage, and 50% will discontinue drainage because the pleural cavity 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 cavity daily will provide adequate treatment for 75% of patients with malignant pleural effusion. The amount of pleural effusion that must be drained from the pleural cavity can vary considerably from patient to patient and from daily routine, and generally, the amount of effusion drained decreases with each subsequent drainage. Typical effusion drainage may begin at approximately 500 ml per day and decrease to approximately 0 ml per day after 12 weeks. Assume the decrease in drainage volume is described by the following first-order differential equation:

[0164]

[0165] Where dV is the flow rate within an infinitesimally small time interval dt.

[0166] V represents attracting traffic, and

[0167] λ is the attenuation constant.

[0168] Solving this equation yields an exponential decay in the drainage process, as shown below.

[0169] V(t) = V0e -λt

[0170] Where V(t) is the flow rate at a given date t, and

[0171] V0 represents the traffic generated 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 high 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 would 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 would not require further intervention. The required daily drainage value based on this relationship or any other desired relationship can be put into a lookup table for controlling the electromechanical pump. The lifespan of the power supply can be extended by allowing the daily pump volume to decrease over time.

[0173] The pump must perform the task of moving fluid through a pipe from a first position to a second position, which can be derived from Bernoulli's equation, and the equation is given as:

[0174]

[0175] in

[0176] E 泵 It is the energy that the pump imparts to each unit mass of 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] It is the average velocity of the fluid at position 1.

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

[0182] g is the gravitational force 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 caused by friction when fluid flows through a pipe.

[0186] The main frictional loss that causes fluid to move from position one to position two through the pipe can be derived as follows:

[0187]

[0188] in

[0189] E 摩擦 The main energy loss is due to friction when fluid flows through a pipe.

[0190] f is the coefficient of friction of the pipe.

[0191] It is the average velocity of the fluid as it passes through the pipe.

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

[0193] d is the diameter of the pipe.

[0194] Combining these two equations, we get:

[0195]

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

[0197]

[0198] If we use volumetric flow rate instead of the average velocity in the pipe, the relationship is:

[0199]

[0200] in

[0201] Q2 is the volumetric flow rate of the fluid passing through the pipe, and

[0202] k is a correction factor considering velocity distribution, and the pump energy equation becomes:

[0203]

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

[0205] P1, pleural cavity pressure = -5cmH2O = 490Pa

[0206] P2, peritoneal pressure = +20cmH2O = 1961Pa,

[0207] ρ, density of the exudate = 1,000 kg / m³ 3 ,

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

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

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

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

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

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

[0214]

[0215] Therefore, under the above assumptions, according to this simplified model, each kilogram of exudate moving from the patient's first region 220 to the patient's second region 230 would consume 8.041 J of energy.

[0216] To further refine the model, if a second friction term is added to the above equations to account for the narrow connector with a length of 1 cm and a diameter of 1 mm, then...

[0217]

[0218] Interestingly, the frictional energy contributed by a 1 cm long and 1 mm diameter connector is 8 times (8X) that contributed by a 30 cm long and 3 mm diameter tube. Therefore, under the modified assumptions described above, moving one kilogram of exudate from the patient's first region 220 to the patient's second region 230 using a narrow tube comprising 1 cm long and 1 mm diameter would consume 53.09 J of energy. Furthermore, for an electromechanical pump 118 operating at 50% efficiency, 106.2 J of energy must be provided to move 1 kg of exudate. Therefore, during the initial 3 months when an estimated 27 liters of exudate must be moved, the power supply should expect to provide at least 2,866.9 J of energy. Furthermore, in order to allow for a larger pressure gradient between the first region 220 and the second region 230 of the patient, to allow for higher frictional losses in the tube (especially for a given tube diameter), and to allow for lower efficiency, the power supply 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 of energy. For reference, an AA battery rated at 2800 mAh and operating at 1.5V contains 15,120 J of energy.

[0219] In addition, in E 泵 Given the strong dependence on the diameter of the pipes and connections required for fluid transfer between the first region 220 and the second region 230, it is desirable that all pipe, connection, and opening diameters (despite the operation of one-way valves, such as opening and closing) in the electromechanical automatic pump-based fluid management system 108 be 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 is desirable that the length of connections and openings less than 1 mm be limited to a length equal to or less than 1 cm, preferably equal to or less than 0.5 cm, and more preferably equal to or less than 0.2 cm.

[0220] The activation and operation of the electromechanical pump 118 can be optimized based on the fluid movement requirements between the patient's first region 220 and second region 230. For the aforementioned pleural cavity to peritoneal cavity, the required exudate movement could be 500 ml on day 1, decreasing to less than 25 ml over time by day 84, or 1 liter on day 1 and decreasing to less than 50 ml over time by day 84. In this case, the controller 530 can be programmed to turn on the pump for a period of time based on the pump's capacity, which would pump the required volume of fluid on the first day and reduce the pump's on-time each subsequent day, for example, according to the following relationship:

[0221] V(t) = V0e -λt

[0222] in

[0223] As an example, V0 is 1 liter.

[0224] λ is 1 / 28, and

[0225] t is the number of days after implantation.

[0226] Alternatively, the pump start-up time can be based on a lookup table with the required daily drainage volume. The electromechanical pump 118 can be turned on once a day to pump the entire required volume of fluid in one go, or the total pump start-up 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. Other modes of pump start-up and shut-off times can also be used.

[0227] Furthermore, the controller 530 can be designed with a sensing feature that monitors fluid flow when the electromechanical pump 118 is turned on and can turn off the electromechanical pump 118 once the fluid flow stops. For example, if the initially estimated or expected fluid flow rate on day 1 is 1 liter, but the flow stops after 550 ml of fluid has been pumped, the controller 530 can be programmed to turn off the electromechanical pump 118. Alternatively, the electromechanical pump 118 can simply be turned on every hour or other suitable time period and kept on until the fluid flow rate drops below a predetermined value, such as, but not limited to, 1 ml / min or 5 ml / min. Additionally, the controller 530 can be designed with a sensing feature that monitors the internal pressure of the pump when the electromechanical pump 118 is turned on and is programmed to turn off the electromechanical pump 118 when the internal pressure drops below a predetermined value. For example, 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, the controller can shut down the electromechanical pump 118.

[0228] In 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 in other alternatives, can be used to achieve a similar function. In practice, electromechanical pump 118 can be a gear pump, screw pump, rotary vane pump, diaphragm pump, piezoelectric diaphragm pump, plunger pump, peristaltic pump, cam pump, piston pump, centrifugal pump, or any other type of pump.

[0229] h. Design of pleural and peritoneal electromechanical pumps and automatic intercostal pumps

[0230] Reference Figure 24A and Figure 24B A fluid management system 109 based on a combined electromechanical pump and an automatic inter-branch pump is shown, which is combined as described above, for example... Figure 11A and Figure 11B Interrib pump 113 operating as described above, and as shown in the example Figures 23A to 23D The electromechanical pump 118 is described. These pumps may share a common internal cavity 330, a one-way inlet valve 320, and a one-way outlet valve 322. In operation, the inter-rib pump 113 may cyclically compress and depressurize between the first and second ribs to generate a continuous fluid flow between the pump inlet 130 and the pump outlet 132. The electromechanical pump 118 may be configured to supplement the fluid flow as needed.

[0231] 5. Other fluid management systems based on automatic pumps

[0232] 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 the drainage of fluid from a patient's pleural cavity to a patient's peritoneal cavity.

[0233] One example of an alternative use of the fluid management system incorporating the intercostal pump described herein is the drainage of fluid from a patient's cerebrospinal region. According to this alternative use, tube 120 can be configured to extend from the automatic pump 110 to the patient's cerebrospinal region, such that the tube inlet end 150 can be positioned within the patient's cerebrospinal region. In this way, excess cerebrospinal fluid can be drained.

[0234] Another example of an alternative use of a fluid management system incorporating the intercostal pump described herein is the drainage of fluid from the pericardial region of a patient.

[0235] Other alternative uses are certainly possible. In general, a fluid management system incorporating the intercostal pump described herein can be used to drain fluid into and from any combination of areas of a patient’s body, which can be adequately fluidly connected with any automated intercostal pump-based fluid management system 100 described herein.

[0236] 6. Fluid management system based on automatic pumps with a storage tank

[0237] Reference Figure 25 A fluid management system 1000 based on an automated 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 of 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, fluid is drained from the patient's pleural cavity 220 to an external reservoir 1020.

[0238] In this embodiment, the automatic intercostal pump 1010 is configured such that it 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 it. Therefore, a first tube 120 and a corresponding pump inlet 130 are positioned inside the patient's pleural cavity. A second tube 122 and a corresponding pump outlet 132 are positioned outside the patient's pleural cavity. In this way, during breathing and corresponding compression / decompression of the pleural cavity, the patient 210 will automatically operate (e.g., "pump") the intercostal pump 1010. This configuration allows fluid in the pleural cavity to be actively pumped out while minimizing hardware movement.

[0239] 7. Methods for draining fluids from a patient's body using an automated pump-based fluid management system.

[0240] Methods for diverting fluid from a first area of ​​a patient or body to a second area of ​​the patient or body can typically be performed by implanting and using any of the various automated pump-based fluid management systems described herein. (Refer to...) Figure 26A In method 800, an example of a method for draining pleural fluid, 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 the 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 pumps, such as intercostal pumps 110, 111, 112, etc., can be implanted using any suitable known or undiscovered surgical technique. At step 804, fluid communication is established between a first region of the patient and the 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 the outlet 132 of the intercostal pump, such as intercostal pumps 110, 111, 112, etc. For example, a second tube, such as second tube 122, may extend from outlet 132 into 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 the patient's first region via the first tube through the intercostal pump and via the second tube to the patient's second region.

[0241] For example, intercostal pumps, such as intercostal pumps 110, 111, 112, etc., can be compressed between the first rib, such as the first rib 412, and the second rib, such as the second rib 414, during the patient's respiratory cycle. Specifically, see... Figure 26BIn method 850, at step 852, the intercostal pumps, such as intercostal pumps 110, 111, 112, etc., are depressurized. For example, the intercostal pumps, such as intercostal pumps 110, 111, 112, etc., are initially compressed between the first rib 412 and the 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 thoracic cavity expands and the first rib 412 and the second rib 414 move away from each other. Therefore, the intercostal pumps, such as intercostal pumps 110, 111, 112, etc., are depressurized. At step 854, the intercostal pumps, such as intercostal pumps 110, 111, 112, etc., draw in fluid. That is, due to the depressurization of the intercostal pumps, such as intercostal pumps 110, 111, 112, etc., at step 852, the pumping force draws fluid into the internal space of the intercostal pumps, such as intercostal pumps 110, 111, 112, etc., such as internal space 330. At step 856, the intercostal pumps, such as intercostal pumps 110, 111, and 112, are compressed. For example, the intercostal pumps, such as intercostal pumps 110, 111, and 112, are compressed between the first rib 412 and the second rib 414 due to the patient's chest cavity contraction (i.e., the patient exhaling). When the patient exhales, the chest cavity contracts and the first rib 412 and the second rib 414 move toward each other. Therefore, the intercostal pumps, such as intercostal pumps 110, 111, and 112, are compressed. At step 858, the intercostal pumps, such as intercostal pumps 110, 111, and 112, output fluid. That is, due to the compression of the intercostal pumps, such as intercostal pumps 110, 111, and 112, at step 856, the pumping force forces the fluid out of the internal space, such as internal space 330, of the intercostal pumps, such as intercostal pumps 110, 111, and 112. In some methods, an electromechanical pump, such as electromechanical pump 118, can be used in place of or as an addition to an inter-rib pump, such as inter-rib pump 110, 111, 112, etc.

[0242] 8. Other matters

[0243] As used herein, the terms “substantially” or “largely” refer to the complete or near-complete extent or degree of an action, characteristic, attribute, state, structure, item, or result. For example, an object “substantially” or “largely” enclosed will mean that the object is either completely enclosed or almost completely enclosed. In some cases, the degree of deviation allowed for absolute completeness may depend on the specific circumstances. However, in general, almost completeness will have a substantially the same overall effect or result as if absolute and completeness were achieved. When used negatively, the use of “substantially” or “largely” also applies to referring to the complete or near-complete absence of an action, characteristic, attribute, state, structure, item, or result.

[0244] Unless otherwise stated, the phrases “at least one of [X] and [Y]” or “at least one of [X] or [Y]” as used herein 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], wherein [X] and [Y] are different components that may be included in the embodiments of this disclosure. Similarly, when referring 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 three or more components, any combination or subcombination of any components, or all components.

[0245] The foregoing describes exemplary embodiments of a fluid management system based on an automatic pump. These exemplary embodiments are not intended to be exhaustive or to limit the invention to the precise forms disclosed. Obvious modifications or variations are possible in light of the foregoing teachings. Various embodiments were chosen and described to provide the best illustration of the principles of this disclosure and its practical application, and to enable those skilled in the art to utilize various embodiments with various modifications suitable for the particular intended use. All such modifications and variations are within the scope of this disclosure as defined by the appended claims when interpreted with a just, lawful and equitable breadth of right.

Claims

1. A pump-based fluid management system, the pump-based fluid management system comprising: A pump body having an internal chamber in fluid communication with an inlet and an outlet; A one-way inlet valve, the one-way inlet valve being located near the inlet and configured to allow fluid to move from the inlet to the inner chamber and at least substantially prevent fluid from moving from the inner chamber to the inlet; A one-way outlet valve, the one-way outlet valve being located near the outlet and configured to allow fluid to move from the inner chamber to the outlet and at least substantially prevent fluid from moving from the outlet to the inner chamber; as well as A first tube, configured to extend from the inlet and allow fluid to move from a first region of the patient's body to the inlet; as well as A second tube is configured to extend from the outlet and allow fluid to move from the outlet to a second area of ​​the patient's body; Wherein, at least one of the one-way inlet valve and the one-way outlet valve is configured to reseal with a back pressure differential of less than 15 cm H2O.

2. The pump-based fluid management system according to claim 1, wherein, The back pressure difference is less than 5 cm H2O when at least one of the one-way inlet valve and the one-way outlet valve is resealed.

3. The pump-based fluid management system according to any one of claims 1 or 2, wherein, Both the one-way inlet valve and the one-way outlet valve are configured to resist deformation caused by applied back pressure once resealed.

4. The pump-based fluid management system according to claim 1, wherein, Applying a back pressure of 50 cm H2O to the one-way inlet valve or the one-way outlet valve results in a deformation of less than 200 μL in the one-way inlet valve or the one-way outlet valve.

5. The pump-based fluid management system according to claim 1, wherein, At least a portion of the pump body includes a generally circular cross-section with an inner diameter between 4 mm and 10 mm and an outer diameter between 6 mm and 12 mm.

6. The pump-based fluid management system according to claim 5, wherein, The pump body comprises at least a generally circular cross-section with an inner diameter between 6 mm and 7 mm and an outer diameter between 8 mm and 10 mm.

7. The pump-based fluid management system according to any one of claims 5 or 6, wherein, The at least portion of the pump body includes a wall thickness between 0.7 mm and 1.0 mm.

8. The pump-based fluid management system according to any one of claims 1, 2, or 4 to 6, wherein, The pump body includes at least one reinforcing member that is incorporated into or attached to the wall of the pump body and configured to distribute forces applied to the wall along its length.

9. The pump-based fluid management system according to any one of claims 1, 2, or 4 to 6, wherein, At least a portion of the pump body is made of a self-sealing material.

10. The pump-based fluid management system according to any one of claims 1, 2, or 4 to 6, further comprising an auxiliary inlet port that is in fluid communication with the internal chamber and is made of a self-sealing material.

11. The pump-based fluid management system according to any one of claims 1, 2, or 4 to 6, wherein, The pump body is at least one of the following: Includes a directional feature configured to engage with at least one rib of the patient user when the pump body is implanted between adjacent ribs, and configured to orient the pump body relative to the at least one rib at a desired angle; or The pump body includes a transition section that angles a first portion of the pump body including the inlet relative to a second portion of the pump body including the outlet.

12. The pump-based fluid management system according to any one of claims 1, 2, or 4 to 6, wherein, At least a portion of the pump body, the first pipe, or the second pipe is coated with at least one of an anticoagulant or a fibrinolytic agent.

13. The pump-based fluid management system according to claim 12, wherein, At least a portion of the pump body, the first tube, or the second tube is coated with heparin.

14. The pump-based fluid management system according to claim 13, wherein, At least a portion of the pump body is coated with heparin.

15. A fluid management system based on an electromechanical pump, the fluid management system based on the electromechanical pump comprising: An electromechanical pump, wherein the electromechanical pump is in fluid communication with an inlet and an outlet; as well as A first tube, configured to extend from the inlet and allow fluid to move from a first region of the patient's body to the inlet; as well as A second tube is configured to extend from the outlet and allow fluid to move from the outlet to a second area of ​​the patient's body; The electromechanical pump includes: An actuator capable of moving fluid from the inlet to the outlet; A controller, operably connected to and capable of controlling the actuator; and A battery, which is operatively connected to the controller to provide power to the controller and the actuator.

16. The fluid management system based on an electromechanical pump according to claim 15, wherein, A one-way valve is located near either the inlet or the outlet, and the one-way valve is configured to prevent backflow from the outlet to the inlet.

17. The fluid management system based on an electromechanical pump according to any one of claims 15 or 16, wherein, The battery is configured to have sufficient energy to enable the electromechanical pump to move at least 27 liters of fluid from the inlet to the outlet.

18. The fluid management system based on an electromechanical pump according to any one of claims 15 or 16, wherein, The controller is programmed to operate the actuator in each of a plurality of operations within a first time period, and for each of the plurality of operations, to continue operating the actuator for a specific time period less than the first time period.

19. The fluid management system based on an electromechanical pump according to any one of claims 15 or 16, wherein, The controller is programmed to operate the actuator for a period of time to pump a desired volume of fluid on the first day after the electromechanical pump-based fluid management system is implanted into the patient user, and then reduce the amount of time the pump operates the actuator for at least one day after implantation.

20. The electromechanical pump-based fluid management system according to any one of claims 15 or 16, further comprising a sensor that senses the fluid flow rate through the electromechanical pump, wherein, The controller is programmed to operate the actuator at each of a plurality of times over a period of time, and for each of the plurality of times, to continue operating the actuator until the sensed fluid flow rate drops below a specified value.

21. The electromechanical pump-based fluid management system according to any one of claims 15 or 16, further comprising a sensor that senses pressure within the electromechanical pump, and wherein, The controller is programmed to operate the actuator at each of a plurality of times over a period of time, and for each of the plurality of times, to continue operating the actuator until the sensed pressure drops below a specified value.

22. The fluid management system based on an electromechanical pump according to claim 15, wherein, The electromechanical pump includes: A pump body having an internal chamber in fluid communication with the inlet and the outlet; A one-way inlet valve, the one-way inlet valve being located near the inlet and configured to allow fluid to move from the inlet to the inner chamber and at least substantially prevent fluid from moving from the inner chamber to the inlet; A one-way outlet valve, the one-way outlet valve being adjacent to the outlet and configured to allow fluid to move from the inner chamber to the outlet and at least substantially prevent fluid from moving from the outlet to the inner chamber; and A liquid-impermeable membrane that separates the inner chamber from a housing compartment comprising the actuator, the controller, and the battery; The actuator is operably connected to the liquid-impermeable membrane and is capable of deforming the liquid-impermeable membrane.

23. The electromechanical pump-based fluid management system according to any one of claims 15, 16, or 22, wherein, At least a portion of the electromechanical pump, the inlet, the outlet, the first pipe, or the second pipe is coated with at least one of an anticoagulant or a fibrinolytic agent.

24. The fluid management system based on an electromechanical pump according to claim 23, wherein, At least a portion of the electromechanical pump, the inlet, the outlet, the first pipe, or the second pipe is coated with heparin.

25. The fluid management system based on an electromechanical pump according to claim 24, wherein, At least a portion of the electromechanical pump is coated with heparin.

26. A fluid management system based on an electromechanical pump, the fluid management system based on the electromechanical pump comprising: An electromechanical pump, which is in fluid communication with an inlet and an outlet, comprises: An actuator capable of moving fluid from the inlet to the outlet; and A battery, which is operatively connected to the actuator to provide power to the actuator; At least a portion of the electromechanical pump is coated with heparin.

27. The fluid management system based on an electromechanical pump according to claim 26, further comprising: A first tube, configured to extend from the inlet and allow fluid to move from a first region of the patient's body to the inlet; as well as The second tube is configured to extend from the outlet and allow fluid to move from the outlet to a second area of ​​the patient's body.

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