Automatic Pleural and Peritoneal Pumps

Abstract

The automated pump-based fluid management system described herein generally includes an intercostal pump having a resilient, flexible valve with an inlet and an outlet. The inlet is attached to a first tube extending from the intercostal pump to a first region of the patient's body, such as the patient's pleural cavity. The outlet is connected to a second tube extending from the intercostal pump to a second region of the patient's body, such as the patient's peritoneal cavity. In use, the intercostal pump is positioned between the patient's first and second ribs. The intercostal pump operates by continuous compression and decompression between the first and second ribs as the patient breathes.

Description

[Background technology]

[0001] Many methods for draining bodily fluids include the use of pumps in combination with shunts or catheters to drain fluids from one cavity within the body to either another cavity or to a reservoir outside the body. Such methods may be utilized for purposes including draining a patient's blood, urine, saliva, cerebrospinal fluid, peritoneal fluid, and / or pleural fluid, among others.

[0002] One application of drainage techniques is the drainage of pleural fluid for the treatment of pleural effusion. Pleural fluid is a low-protein liquid that is normally found in relatively small amounts (usually 10-20 milliliters) in each of a patient's pleural cavities. The pleural cavity is the space between the visceral pleura (i.e., the membrane located across the outer surface of each lung) and the parietal pleura (i.e., the membrane lining the interior of the chest wall of each hemithorax). The small amount of pleural fluid in each pleural cavity is spread very thinly between the visceral and parietal pleura, thereby providing a large surface tension that mechanically connects the lungs to the chest wall while at the same time lubricating these surfaces and allowing the lungs to slide over the chest wall during the breathing process. In normal healthy individuals, pleural fluid always results from leakage of fluid primarily from blood vessels and lymphatic vessels within the visceral pleura covering the outer surface of the lungs, and is reabsorbed at essentially the same rate by lymphatic vessels located in the parietal pleura covering the chest wall. This dynamic equilibrium allows fluid to be exchanged multiple times daily, maintaining a small total volume in the range of 10-20 milliliters. However, in certain abnormal conditions, such as infection, inflammation, malignancy, cardiac failure, hepatic failure, or renal failure, among others, the net flow of pleural fluid within the pleural cavity can become unbalanced due to increased fluid production, decreased resorption, or both, resulting in an excessive accumulation of fluid within the pleural cavity (e.g., on the order of hundreds of milliliters to several liters).

[0003] Excessive accumulation of pleural fluid, known as pleural effusion, adds additional mass that must be displaced with each breath and can cause pathologic compression of lung tissue, making the breathing process significantly more difficult or impeded. Pleural effusion can result in, for example, dyspnea, shortness of breath, chest pain, and / or chronic coughing, which can significantly impair a patient's quality of life.

[0004] Currently, approximately 1.5 million new patients suffer from pleural effusions each year in the United States. Many of these effusions are chronic, recur despite drainage, and can be highly symptomatic and debilitating. One common type of recurrent symptomatic pleural effusion is due to malignancy. Over 200,000 cases of malignant pleural effusion occur annually in the United States, and more than half of these patients with malignant pleural effusions have recurrent symptoms directly caused by the patient's effusion.

[0005] Treatment options for recurrent symptomatic pleural effusion can be divided into 1) repeated drainage of the pleural fluid and 2) evacuation of the pleural cavity. One approach to the treatment of recurrent symptomatic pleural effusion is to perform 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 within the pleural cavity. The catheter remains in place, thereby acting as a drainage tube that allows excess pleural fluid to be moved from the pleural cavity to a collection reservoir outside the body. This procedure usually results in significant improvement of symptoms. Unfortunately, malignant effusions are likely to recur after drainage, and therapeutic thoracentesis must be frequently repeated to control symptoms. However, delays in patients in informing their physicians that symptoms have recurred, and delays in establishing and providing repeated thoracentesis, often result in patients living with effusion-related symptoms for a significant portion of their lives. Furthermore, thoracentesis is painful and uncomfortable, and is otherwise frequently associated with complications such as pneumothorax (i.e., collapse of the lung due to accumulation of air in the pleural cavity) and severe bleeding or infection.

[0006] Another treatment option is pleurodesis. Pleurodesis is the occlusion of the pleural cavity by injection of a sclerosing agent into the pleural cavity and adhesion of the visceral and parietal pleural surfaces. In one approach, the sclerosing agent is introduced through a chest tube inserted into the patient under moderate sedation or general anesthesia for drainage of the pleural fluid, similar to the drainage achieved with thoracentesis. After drainage of the fluid, a sclerosing agent is injected through the tube into the pleural cavity, completely coating these membranes and permanently attaching the visceral and parietal membranes to each other, and the pleural cavity is closed and removed. Chest tube pleurodesis may lead to long-term control of effusion-related symptoms. Unfortunately, chest tube pleurodesis usually requires a hospital stay of at least 2 days and up to 7 days, can be quite painful, can lead to pleurodesis-related dyspnea, and up to one-third of patients fail to obtain relief of symptoms for more than a few weeks.

[0007] Another variation of pleurodesis is thoracoscopic pleurodesis, which involves inserting a telescope into the patient's chest through an intercostal incision in the patient's side. Pleural fluid is drained and a detailed examination of the pleural cavity is performed to more carefully identify and apply a sclerosing agent to abnormal areas. In some cases, thoracoscopic pleurodesis can achieve better results than chest tube pleurodesis. Unfortunately, thoracoscopic pleurodesis also requires a prolonged hospital stay, usually 4-7 days, and can be quite painful, leading to pleurodesis-related respiratory distress, with many patients not finding relief for more than a few weeks.

[0008] Yet another treatment option is the chronic indwelling pleural catheter. Such an indwelling catheter is permanently placed within the patient and allows the patient to drain pleural fluid intermittently but continuously into an external reservoir. That is, the pleural catheter is placed into the affected pleural cavity within the patient's body at one end, and the other end of the catheter extends outside the patient's body and remains exposed to the outside for an extended period of time. Chronic indwelling catheters have been shown to provide a relatively high success rate in managing effusion-related symptoms, with the associated patient hospital stay being relatively short, about one day. However, because the catheter passes through the patient's skin, partly inside and partly outside the body, a significant proportion of patients (about 8 percent) suffer from infection. Additionally, the patient is subject to the discomfort, irritation and annoyance of the exposed indwelling catheter. Finally, to relieve effusion-related symptoms, the patient or the patient's caregiver must actively access the exterior portion of the catheter, connect the catheter to an external reservoir, and drain the effusion from the pleural cavity into the reservoir.

[0009] Yet another approach is the pleuroperitoneal shunt. A pleuroperitoneal shunt provides a permanent conduit between the pleural cavity and the peritoneal cavity or abdomen, allowing fluid to move from the pleural cavity to the peritoneal cavity as opposed to an external reservoir. Once in the peritoneal cavity, the fluid is reabsorbed into the patient's bloodstream through blood vessels and lymphatics located in the abdomen. In a typical pleuroperitoneal shunt, the shunt has a pumping chamber that must be manually activated by the patient or caregiver to move the pleural fluid. A pleuroperitoneal shunt passes under the skin from the chest to the abdomen with the pumping chamber located in a subcutaneous pocket overlying the bony rib cage. Similar to chronic indwelling catheters, pleuroperitoneal shunts have been shown to provide a relatively high success rate in managing effusion-related symptoms, with associated patient hospitalizations being relatively short, at approximately one day. However, again similar to chronic indwelling catheters, a significant proportion of patients (approximately 4 percent) develop infections. Further disadvantages of conventional pleuroperitoneal shunts include a relatively high rate of shunt-specific complications, such as clotting of fluid within the shunt. Finally, to alleviate effusion-related symptoms, the patient or the patient's caregiver must actively compress the pumping chamber multiple times to transfer the effusion from the pleural to the peritoneal cavity, which causes considerable discomfort and inconvenience.

[0010] Other applications of drainage techniques exist. These include, but are not limited to, drainage of pericardial fluid, cerebrospinal fluid, peritoneal fluid, urine, bile and lymphatic fluid. Cavities from which these fluids can be drained include, but are not limited to, the pleural cavity, the peritoneal cavity, the bile duct, the stomach, the lymphatic ducts including the thoracic duct, the veins including the vena cava, and the urinary bladder.

[0011] The background discussion provided herein is intended to generally present the context of the present disclosure. The work of the currently named inventors, to the extent described in this Background section, along with aspects of the present disclosure that are not admitted as prior art at the time of filing, are not admitted expressly or impliedly as prior art to the present disclosure. Summary of the Invention

[0012] There is a need for novel techniques for draining pleural fluid that provide a high success rate in treating pleural effusions, avoid high rates of infection and other complications, do not require lengthy patient hospital stays and / or repeated hospital visits, and avoid the inconvenient need to manually compress the pumping chamber multiple times each day or physically connect a catheter to an external reservoir to relieve symptoms. The automated pump-based fluid management system described herein provides such a novel and beneficial drainage technique.

[0013] The fluid management system using an automated pump described herein generally includes a pump that is a pumping chamber having a first one-way valve disposed at an inlet to the pumping chamber and a second one-way valve disposed in series with the first valve at an outlet from the pumping chamber. The volume of the pumping chamber in contact with the fluid can be increased or decreased. The inlet is attached to a first tube extending from the automated pump to a first region of the patient's body, for example the pleural cavity of the patient. The outlet is connected to a second tube extending from the automated pump to a second region of the patient's body. The second region of the patient's body can be, for example, the peritoneal cavity of the patient. Operation of the automated pump transfers fluid from the first region of the patient's body to the second region.

[0014] In one embodiment, the pumping chamber of the automatic pump is a resilient flexible tube, and the pumping chamber is placed between the first and second ribs of the patient. (Note that it should be understood that such use does not necessarily refer to a particular two ribs, e.g., the "first" and "second" ribs, which are typically referred to in an anatomical context as the two ribs closest to the patient's skull.) The automatic pump operates by the pumping chamber being continually compressed and decompressed between the first and second ribs as the patient breathes. When the patient inhales, the patient's bony rib expands, the intercostal space (i.e., the space between the first and second ribs) increases, and the pumping chamber is decompressed. When the patient exhales, the patient's bony rib contracts, the intercostal space narrows, and the pumping chamber is compressed. For a person who breathes 12 times per minute, this means that the pumping chamber is compressed and decompressed 17,280 times per day.

[0015] In another embodiment, the pumping chamber of the automatic pump is a resilient, elongated, flexible tube with a portion of the pumping chamber disposed between the first and second ribs of the patient and a second portion of the elongated pumping chamber disposed in the patient's subcutaneous tissue between the bony thorax and the skin. Thereby, the automatic pump can be operated in two ways. First, by the pumping chamber being continuously compressed and decompressed between the first and second ribs as the patient breathes, thereby cyclically changing the volume of the pumping chamber. Second, by the patient or caregiver manually compressing a portion of the elongated pumping chamber disposed between the bony thorax of the patient and the patient's skin. Thus, when the patient breathes in, a portion of the pumping chamber disposed between the first and second ribs is decompressed, and when the patient breathes out, a portion of the pumping chamber is compressed, thereby providing automatic pumping. Additionally, if excessive exudate is determined to be present in the pleural cavity based on the patient's symptoms, radiographs, or ultrasound examinations, the patient or the patient's caregiver can manually compress, possibly repeatedly, a portion of the pumping chamber between their fingers or hand and the bony thorax to provide additional pumping action.

[0016] In yet another embodiment, the pumping chamber of the automatic pump has a first portion composed of a resilient flexible tube arranged between the first and second ribs of the patient, and a second portion composed of a semi-rigid chamber with an electromechanical pump capable of assisting the pumping action provided by the first portion. Thereby, the automatic pump can operate not only by, first, compressing and decompressing the first portion of the pumping chamber between the first and second ribs continuously as the patient breathes, thereby periodically changing the volume of the pumping chamber, but also by the periodic change in the volume of the pumping chamber caused by the electromechanical pump of the second portion. Thus, when the patient breathes in, the first portion of the pumping chamber arranged between the first and second ribs is decompressed and filled with exudate from the pleural cavity, and when the patient breathes out, the first portion of the pumping chamber is compressed, forcing body fluids from the pumping chamber to the peritoneal cavity. The electromechanical pump of the second portion is also capable of pumping fluid from the pleural cavity to the peritoneal cavity independent of the operation of the pumping chamber disposed between the first rib and the second rib. The use of an automatic pump as described herein avoids certain shortcomings of known fluid drainage techniques. For example, the intercostal pump operates to drain fluids periodically, continuously, and automatically, without requiring the patient to manually compress the pump using their hands or to drain fluids outside of the patient's body. Furthermore, the continuous operation of the intercostal pump may provide improved performance by reducing the incidence of clotting observed in other fluid drainage systems that may remain inoperative for extended periods of time.

[0017] The foregoing provides a simplified summary of one or more embodiments of the present disclosure to provide a basic understanding of such embodiments. This summary is not an extensive overview of all contemplated embodiments, nor does it identify key or critical elements of all embodiments, nor does it describe in detail the scope of all or part of the embodiments. Other embodiments of the present disclosure will become apparent to those skilled in the art from the following detailed description, which shows and describes exemplary embodiments of the present invention. As will be understood, all of the various embodiments of the present disclosure can be modified in various obvious aspects without departing from the present disclosure. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not restrictive.

[0018] The invention disclosed herein will be more readily understood by reading the specification in conjunction with the accompanying drawings, which form a part of the specification. [Brief description of the drawings]

[0019] [Figure 1] FIG. 1 is a perspective view of an automated pump-based fluid management system including a pump and also including inlet and outlet tubes (the inlet and outlet tubes are shown in simplified and shortened form for illustrative purposes). [Figure 2A] A fluid management system that uses an automated pump implanted in the patient. [Figure 2B] A fluid management system that uses an automated pump implanted in the patient. [Figure 2C] A fluid management system that uses an automated pump implanted in the patient. [Diagram 3] Typical pleural and intraperitoneal pressure changes during inspiration and expiration are shown. [Figure 4] FIG. 1 is a perspective view of an automated pump-based fluid management system that includes a pump and also includes inlet and outlet tubes with perforations or fenestrations designed to prevent blockages and improve fluid flow (the inlet and outlet tubes are shown in a shortened schematic form for illustrative purposes). [Diagram 5]FIG. 1 is a perspective view of an automated pump-based fluid management system that includes a pump and also includes inlet and outlet tubes with rounded closed ends and small fenestrations designed to prevent blockage of the system by preventing entry of fibrin strands and particulates into the catheter and pump (the inlet and outlet tubes are shown in a shortened schematic form for illustrative purposes). [Figure 6] FIG. 1 is a perspective view of an automated pump-based fluid management system including a pump, perforated or fenestrated inlet and outlet tubes (the inlet and outlet tubes are shown in a shortened schematic form for illustrative purposes), and a fibrinolytic and / or anticoagulant band on the inlet tube to prevent fibrin and / or clot formation, thereby preventing blockage of the system. [Figure 7] FIG. 1 is a perspective view of an automated pump-based fluid management system including a pump, perforated or fenestrated inlet and outlet tubes (the inlet and outlet tubes are shown in schematic shortened form for illustrative purposes), and a band of fibrosis inducer on the inlet tube to induce localized fibrin and / or clot formation away from the fenestrations, thereby preventing blockage of the system. [Figure 8A] FIG. 1 is a perspective view of a fluid management system using an automated intercostal pump for intercostal use, including a pumping chamber and including perforated or fenestrated inlet and outlet tubes (the inlet and outlet tubes are shown in schematic shortened form for illustrative purposes). [Figure 8B] FIG. 1 is a perspective view of a fluid management system using an automated intercostal pump for intercostal use, including a pumping chamber, an inlet tube with a straight fluid channel, and a perforated or fenestrated outlet tube (the inlet and outlet tubes are shown in schematic shortened form for illustrative purposes). [Figure 9] A fluid management system using an automated intercostal pump implanted in the patient. [Figure 10A]1A-1C are schematic cross-sectional views of a pumping chamber with a one-way inlet valve and a one-way outlet valve, and various positions or conditions of the inlet and outlet one-way valves when the pumping chamber is compressed. [Figure 10B] 1A-1C are schematic cross-sectional views of a pumping chamber with a one-way inlet valve and a one-way outlet valve, and various positions or conditions of the inlet and outlet one-way valves when the pumping chamber is compressed. [Figure 10C] 1A-1C are schematic cross-sectional views of a pumping chamber with a one-way inlet valve and a one-way outlet valve, and various positions or conditions of the inlet and outlet one-way valves when the pumping chamber is compressed. [Figure 10D] 1A-1C are schematic cross-sectional views of a pumping chamber with a one-way inlet valve and a one-way outlet valve, and various positions or conditions of the inlet and outlet one-way valves when the pumping chamber is compressed. [Figure 10E] FIG. 1 is a cross-sectional schematic diagram of a pumping chamber with a one-way inlet valve and a one-way outlet valve, and a stiffener within the pumping chamber designed to provide a greater volume change to the pumping chamber for a given application of force. [Figure 10F] FIG. 1 is a cross-sectional schematic diagram of a pumping chamber with a one-way inlet valve and a one-way outlet valve, and a stiffener within the pumping chamber designed to provide a greater volume change to the pumping chamber for a given application of force. [Figure 11A] FIG. 1 is a perspective view of a fluid management system using an automated intercostal pump and the relationship of the pumping chamber to the patient's ribs during inspiration and expiration. [Figure 11B] FIG. 1 is a perspective view of a fluid management system using an automated intercostal pump and the relationship of the pumping chamber to the patient's ribs during inspiration and expiration. [Figure 12] 1A and 1B are schematic cross-sectional views of a one-way inlet valve in a closed state and an open state, and a schematic cross-sectional view of a one-way outlet valve in a closed state and an open state. [Figure 13]FIG. 1 is a perspective view of a fluid management system using an automated intercostal pump including a pumping chamber, an inlet tube with a rounded closed end, an inlet hole sized to accommodate the inlet and outlet valves, and an outlet tube (the inlet and outlet tubes are shown in a shortened schematic form for illustrative purposes). [Figure 14A] FIG. 1 is a perspective view of a fluid management system using an automated intercostal pump, including a pumping chamber, an inlet tube, an outlet tube, and a stabilization and orientation mechanism (the inlet and outlet tubes are shown in a shortened schematic form for illustrative purposes). [Figure 14B] FIG. 1 is a perspective view of a fluid management system using an automated intercostal pump with a stabilization and orientation mechanism and the relationship of the pumping chamber to the patient's ribs. [Figure 15A] FIG. 1 is a perspective view of a fluid management system using an automated intercostal pump, including a pump shaped to better fit the transition from the pleural cavity to the subcutaneous tissue, and including perforated or fenestrated inlet and outlet tubes (the inlet and outlet tubes are shown in schematic shortened form for illustrative purposes). [Figure 15B] FIG. 15B is a schematic cross-sectional view of a pump in a body fluid management system using the automatic intercostal pump shown in FIG. 15A. [Figure 16A] FIG. 1 is a perspective view of a fluid management system using an automated intercostal pump including a pump shaped to better conform to the transition from the pleural cavity to the subcutaneous tissue and to better prevent displacement once in place, and including perforated or fenestrated inlet and outlet tubes (the inlet and outlet tubes are shown in schematic shortened form for illustrative purposes). [Figure 16B] FIG. 16B is a cross-sectional schematic diagram of a pump in a body fluid management system using the automatic intercostal pump shown in FIG. 16A. [Figure 17] FIG. 1 is a perspective view of a fluid management system using an alternative automated intercostal pump, including a pump shaped to better conform to the transition from the pleural cavity to the subcutaneous tissue and better prevent displacement once in place (inlet and outlet tubes are shown in schematic shortened form for illustrative purposes). [Figure 18]FIG. 1 is a perspective view of a fluid management system using an alternative automated intercostal pump, including a pump shaped to better conform to the transition from the pleural cavity to the subcutaneous tissue, provide any angle of orientation of the pump relative to the chest wall, and better prevent displacement once placed (inlet and outlet tubes are shown in schematic shortened form for illustrative purposes). [Figure 19] FIG. 1 is a perspective view of an alternative automated intercostal pump fluid management system including a pump shaped to better conform to the transition from the pleural cavity to the subcutaneous tissue, provide any angle of orientation of the pump relative to the chest wall, provide an additional mechanism for securing the automated intercostal pump fluid management system in place, and better prevent displacement once in place (inlet and outlet tubing are shown foreshortened schematic for illustrative purposes). [Figure 20A] FIG. 1 is a perspective view of a fluid management system using an automated intercostal pump including a pump for placement in the intercostal space and a dome-shaped diaphragm that can be manually actuated to improve the overall function of the pump system. [Figure 20B] FIG. 20B is a schematic cross-sectional view of a pump in a body fluid management system using the automatic intercostal pump shown in FIG. 20A. [Figure 21] FIG. 1 is a perspective view of an automated intercostal pump based fluid management system including a pump for placement in the intercostal space, a dome shaped diaphragm that can be manually activated to improve the overall functioning of the pump system, and an access port with a dome shaped septum that can be punctured to allow access to the interior of the automated intercostal pump based fluid management system. [Figure 22] FIG. 13 is a perspective view of an alternative automated intercostal pump based fluid management system including a pump for placement in the intercostal space, a diamond shaped stability and orientation mechanism, and two access ports with dome shaped septa that can be punctured to allow access to various regions within the automated intercostal pump based fluid management system. [Figure 23A] FIG. 1 is a perspective view of fluid management using an electromechanical automated pump with a piezoelectric diaphragm. [Figure 23B]FIG. 23B is a cross-sectional schematic diagram of a pump in a bodily fluid management system using the electromechanical automatic pump shown in FIG. 23A. [Figure 23C] FIG. 23B is a cross-sectional schematic diagram of a pump in a bodily fluid management system using the electromechanical automatic pump shown in FIG. 23A. [Figure 23D] FIG. 23B is a cross-sectional schematic diagram of a pump in a bodily fluid management system using the electromechanical automatic pump shown in FIG. 23A. [Figure 24A] FIG. 1 is a perspective view of a fluid management system using an automated intercostal pump, including a pump for placement in the intercostal space and an electromechanical pump that can be activated to improve the overall function of the pump system. [Figure 24B] FIG. 24B is a schematic cross-sectional view of a pump in a body fluid management system using the automatic intercostal pump shown in FIG. 24A. [Diagram 25] A fluid management system that uses an automated intercostal pump implanted in the patient and connected to an external reservoir. [Figure 26A] FIG. 1 illustrates a method for removing bodily fluids using an automated intercostal pump based fluid management system. [Figure 26B] FIG. 1 illustrates a method for removing bodily fluids using an automated intercostal pump based fluid management system. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0020] The devices, systems and methods described herein may be used to drain and / or move bodily fluids from one cavity to another within the human body. In particular, the devices, systems and methods described herein include an automated pump that provides the pumping functions common in automated fluid management systems.

[0021] For purposes of illustration, the disclosure herein includes a discussion of the use of an automated pumped fluid management system for the purpose of draining pleural fluid for the treatment of pleural effusion, however, it should be understood that such use is merely one particular use of one particular embodiment of an automated pumped fluid management system and that other embodiments and uses are possible.

[0022] Similarly, the disclosure herein, for purposes of illustration, describes an automatic pump as part of a particular automatic pump-based fluid management system, however, it should be understood that any such automatic pump-based fluid management system disclosed herein is merely a specific embodiment of an automatic pump-based fluid management system using an automatic pump as described herein, and that other uses of the automatic pump are possible.

[0023] An automated pump based fluid management system can provide for regular, continuous and automatic drainage of bodily fluids, thereby avoiding many of the shortcomings of other techniques for draining bodily fluids.

[0024] 1. Fluid management system using an automated pump Figure 1 is a perspective view of an automated pump-based fluid management system including an automated pump and inlet and outlet tubes (these depictions are shown in schematic and shortened length for illustrative purposes). It should be understood that Figure 1 shows one embodiment of an automated pump-based fluid management system for illustrative purposes and that other embodiments are possible.

[0025] a. General fluid management systems using automated pumps Referring to FIG. 1, an automated pump-based fluid management system 100 for moving fluid from a first body compartment to a second body compartment generally includes a pump 110 having an inlet 130 and an outlet 132 and capable of moving fluid between the inlet 130 and the outlet 132.

[0026] The automated pump based fluid management system 100 also includes a first tube 120 and a second tube 122. The inlet 130 and the outlet 132 communicate between the interior and the exterior of the pump 110, respectively, and are coupled to the first tube 120 and the second tube 122, respectively. In other words, the inlet 130 and the outlet 132 are configured to provide fluid communication between the first tube 120 and the second tube 122, respectively, and the interior space of the pump 110.

[0027] Additionally, the first tube 120 includes a tube inlet end 150 and a pump inlet end 140. Generally, the first tube 120 is configured such that the tube inlet end 150 is disposed in a region of the human body from which bodily fluid is to be removed when using the automated pump-based fluid management system 100, while the pump inlet end 140 is coupled to the inlet 130 of the pump 110. As such, the length of the first tube 120 may vary, as indicated by the length extension 160.

[0028] Similarly, the second tube 122 includes a pump outlet end 142 and a tube outlet end 152. Generally, the second tube 122 is configured such that the tube outlet end 152 is positioned in an area of ​​the body into which bodily fluid is to be discharged when using the automated pump-based fluid management system 100, while the pump outlet end 142 is coupled to the outlet 132 of the pump 110. As such, the length of the second tube 122 may vary, as indicated by the length extension 162.

[0029] Although the first tube 120 and the second tube 122 are shown entering the pump 110 in a substantially straight line (i.e., perpendicular to the walls of the pump 110), the first tube 120 and the second tube 122 may be configured to enter the pump 110 at any desired angle. For example, it may be desirable for the first tube 120 and the second tube 122 to each enter and exit the pump 110 at an angle of about 90 degrees so that the pump 110 may be more advantageously positioned. It may also be desirable for the first tube 120 and the second tube 122 to enter and exit at other angles.

[0030] Although tubes 120 and 122 are generally shown as flexible tubes that are easily manipulated and shaped or shaped into any form or orientation, in some embodiments it may be desirable for tubes 120 and 122 to be configured to be somewhat rigid or semi-rigid so that a desired shape or orientation of the tubes is maintained. For example, one of the tubes may be at least partially configured, molded or cast to have a 90 degree bend as it leaves intercostal pump 110. Tubes 120 and 122 may each be configured with a similar 90 degree bend. Alternatively, the tubes may not have a similar bend. As yet another alternative, the tubes may each have other degrees of bend.

[0031] To achieve fluid movement using an automatic pump, pump 110 may be an automatic intercostal pump, described in more detail below, consisting of a substantially resilient flexible chamber with a one-way valve at the inlet and a one-way valve at the outlet, which utilizes the movement of the ribs during normal breathing to automatically and cyclically compress and decompress the resilient flexible chamber between adjacent ribs, thereby providing a pumping action. Alternatively, pump 110 may be an electromechanical pump, such as a gear pump, screw pump, rotary vane pump, diaphragm pump, piezoelectric diaphragm pump, plunger pump, peristaltic pump, lobe pump, piston pump or centrifugal pump, described in more detail below. Other types of pumps are possible.

[0032] b. Fluid management system using an automated pleuroperitoneal pump Referring to Figure 2A, an automated pump-based fluid management system 100 is shown implanted in a patient 200 to provide drainage of bodily fluid from a first region 220 to a second region 230 within the patient's body. In one embodiment, similar to the embodiment shown in Figure 2A, bodily fluid is drained from the patient's pleural cavity to the patient's peritoneal cavity. Thus, in such an embodiment, the first region 220 is the patient's pleural cavity and the second region 230 is the patient's peritoneal cavity.

[0033] In one embodiment, the automated pump 110 is configured to be positioned outside the patient's bony thorax 400 beneath the patient's skin. To access the patient's pleural cavity 220, the first tube 120 traverses from the pump inlet 130 across the bony thorax 400 between adjacent ribs, with the tube inlet end 150 of the first tube 120 being positioned in the person's pleural cavity 220 from which bodily fluids will drain. The second tube 122 traverses from the pump outlet 132 beneath the skin along the abdominal wall, with the tube outlet end 152 of the second tube 122 being positioned in the person's peritoneal cavity 230 from which bodily fluids will drain. The peritoneal cavity 230 has a fluid absorption capability such that excess fluids displaced from the pleural cavity 220 are absorbed, for example, into the patient's interstitial tissue, lymphatics, and blood vessels, thereby minimizing the accumulation of fluids within the peritoneal cavity 230.

[0034] In another embodiment, as shown in FIG. 2B, the automatic pump 110 can be configured to be placed in the pleural cavity 220 of a patient. The tube inlet end 150 of the first tube 120 and the first tube 120 can be placed in the pleural cavity 220 of the person from which bodily fluid is to be drained. The second tube 122 enters the peritoneal cavity from the pump outlet 132 of the automatic pump 110 located in the pleural cavity 120 such that the tube outlet end 152 of the second tube 122 is placed in the peritoneal cavity 230 of the person from which bodily fluid is to be drained. The second tube 122 may traverse the bony rib cage 400 between adjacent ribs, travel under the skin along the bony rib cage 400, and traverse the abdominal wall such that the tube outlet end 152 of the second tube 122 is placed in the peritoneal cavity 230 of the person from which bodily fluid is to be drained. Alternatively, the passage of the second tube 122 may pass directly from the patient's pleural cavity 220 through the diaphragm 240 into the patient's peritoneal cavity 230 .

[0035] 2C, the automated pump 110 and outlet second tube 230 can be configured to be positioned within the patient's peritoneal cavity 230, with the first tube passing from the pump inlet 130 through the abdominal wall, beneath the skin, along the bony rib cage 400, across the bony rib cage 400 between adjacent ribs, and entering the pleural cavity 220 such that the tube inlet end 150 of the first tube 120 is located within the pleural cavity. Alternatively, the passage of the first tube 120 may be directly from the patient's pleural cavity 220, through the diaphragm 240, and into the patient's peritoneal cavity 230.

[0036] C. Pleural and peritoneal pressure The pressures in the pleural and peritoneal cavities 220 and 230 are not the same, are not static, and generally vary during normal breathing. Inspiration is an active process that requires muscle contraction. During inspiration, the external intercostal muscles contract, causing the ribs and sternum to rise and the diaphragm to contract, flattening and depressing the abdominal contents. This combined action creates an intrapleural pressure (P pleural ) and intraperitoneal pressure (P peritoneal ), resulting in expansion of the thoracic cavity. Exhalation during normal breathing is a passive process that depends primarily on elastic recoil. During exhalation, the external intercostal muscles and the diaphragm simply relax. With the relaxation of the external intercostal muscles, the elasticity of the inflated lungs causes them to contract and return to their original position. At the same time, the diaphragm relaxes, allowing the compressed abdominal contents to push up against it. This combined action increases the intrapleural pressure (P pleural ) and a decrease in the size of the thoracic cavity due to an increase in intraperitoneal pressure (P peritoneal ) with a simultaneous decrease in

[0037] As can be seen in Figure 3, during normal resting breathing in a patient with little or no pleural effusion, the intrapleural pressure (P pleural ) varies from approximately +3cmH2O at the end of expiration to approximately -2cmH2O at the end of inspiration, and intraperitoneal pressure (P peritoneal) varies from about +5cmH2O at the end of expiration to about +13cmH2O at the end of inspiration. Overall intrapleural pressure is lower than intraperitoneal pressure during the entire respiratory cycle with a gradient that varies on average from about -2cmH2O at the end of expiration to about -15cmH2O 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, Vol. 563, No. 3, pp. 925-943 (2005)]. Intrapleural and intraperitoneal pressures and the intrapleural-to-intraperitoneal pressure gradients vary from patient to patient and are altered by exertion, coughing, sneezing, deep breathing, body position, thoracic or abdominal disease, previous thoracic or abdominal surgery, and the presence of pleural effusion. In fact, the presence of pleural effusion adds a significant hydrostatic component to the intrapleural pressure, which may vary from low or negative values ​​to positive values. In fact, in patients with pleural effusion, the intrapleural pressure (P pleural ) may increase to about +10 to about +15 cmH2O in the presence of exudate and may decrease to about -10 to about -15 cmH2O when the exudate is drained. [Feller-Kopman D, Large-volume thoracentesis and the risk of re-expansion pulmonary edema, Ann Thor Surg, vol. 84, pp. 1656-1662 (2007)]. When the effects of pleural effusion are added to the fluctuations that occur during normal breathing, the intrapleural pressure may be higher than the intraperitoneal pressure during the respiratory cycle with a gradient ranging from about -5 cmH2O to about +13 cmH2O in the presence of exudate.

[0038] For the automated pump fluid management system 100 to transfer fluid from the pleural cavity 220 to the peritoneal cavity 230, the automated pump 110 is able to overcome the pressure gradient that exists from the pleural cavity 220 to the peritoneal cavity 230. As outlined above, this pressure gradient changes during the respiratory cycle and, in the case of a pleural effusion, the amount of exudate present also changes. When the automated pump fluid management system 100 is first deployed 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 valves in the automated pump 110 have a combined opening pressure that is lower than the intrapleural to intraperitoneal pressure gradient.

[0039] When the pleural fluid is nearly drained from the pleural cavity 220, there is a lower intrapleural-to-peritoneal pressure gradient, as shown in FIG. 3. Due to this pressure gradient, at the end of expiration, the automated pump 110 can generate a head 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 automated pump 110 can generate a head pressure of at least about 15 cmH2O to overcome the pressure gradient between the peritoneal cavity 230 and the pleural cavity 220, thereby pumping fluid from the pleural cavity 220 to the peritoneal cavity 230. It should be noted that if the pump generates a constant head pressure, the flow between the pleural cavity 220 and the peritoneal cavity 230 will change during the respiratory cycle because the pressure gradient between the peritoneal cavity 230 and the pleural cavity 220 will change. The above values ​​are based on average observations. In some cases, the pump may generate a head pressure of at least about 25 cmH2O to overcome the variations in pressure gradients present throughout the normal breathing cycle, thereby pumping fluid from the pleural and peritoneal cavities 220 and 230 at any given time, and may even generate a head pressure of 35 cmH2O to 50 cmH2O to overcome patient-to-patient variations. It may further be noted that the automated pump 110 may be designed to operate preferentially during expiration, ideally at the end of expiration, where the pressure gradient between the peritoneal and pleural cavities 230 is lower. In this situation, the automated pump 110 may only need to generate a minimum head pressure of about 5 cmH2O, or preferably about 10 cmH2O to 15 cmH2O, to overcome patient-to-patient variations and pump fluid from the pleural and peritoneal cavities 220 to the peritoneal cavities 230. This lower head pressure translates into a lower rate of power consumption for the automatic pump 110 and less total work time per unit volume of exudate pumped, compared to operation of the automatic pump 110 at the entire respiratory cycle, the beginning of expiration or the end of inspiration.

[0040] D. Pleural fluid debris and coagulation proteins Pleural fluid, whether healthy or diseased, is essentially a filtrate of blood modified by reabsorption. Filtration occurs through the blood vessel walls, interstitial tissue and mesothelial cell membranes on both the visceral and parietal pleural surfaces, and modification occurs by reabsorption of fluid, solutes, proteins and cells. Like the interstitial fluid of other organs, in healthy individuals, pleural fluid contains proteins and a small number of cells. Pleural fluid proteins have a total concentration of about 1.0 g / dl (a plasma total protein concentration of 6.0 g / dl or more), with albumin being the most abundant, accounting for about 50% of the total protein, globulins being the second most abundant, accounting for about 35% of the total protein, and fibrinogen being the third most abundant, accounting for less than 20% of the protein. The cell concentration is about 2,000 cells / mm 3 Pleural fluid volume, composed mainly of mesothelial cells, monocytes and lymphocytes.

[0041] In malignant tumors, this filtration and reabsorption system is out of balance. The cells, membranes, and tissues that help filter the blood tend to be less selective, and the reabsorption mechanisms are altered and usually less efficient. Thus, pleural fluid resulting from malignant tumors is increased in volume, abnormal in composition, the fluid is rich in both proteins and cells, and the types of proteins and cells present are different. Indeed, the total protein concentration of pleural fluid is usually greater than 2.9 g / dl, and the cell concentration may be many times higher.

[0042] Fibrinogen is an important protein in pleural fluid. Fibrinogen is converted to fibrin by thrombin in a process called fibrinogenesis. Fibrin is degraded by the action of plasminogen in a process called fibrinolysis. Meanwhile, plasminogen is activated by tissue plasminogen activator (tPA), which is inhibited by plasminogen activator inhibitor-1 (PAI-1). The net amount of fibrin produced is the result of an imbalance between fibrinogenesis and fibrinolysis.

[0043] Fibrinogen concentrations in pleural fluid are usually low compared to plasma concentrations. Even in patients with malignancies, pleural fluid fibrinogen concentrations tend to be lower when total protein concentrations tend to be elevated, pleural fluid levels of tPA tend to be elevated, and PAI-1 tend to be decreased, all of which tend to lower the net production of fibrin.

[0044] Nevertheless, in patients with malignant pleural effusions, an imbalance between fibrinogenesis and fibrinolysis may still occur, resulting in the formation of fibrin. Fibrin can organize into small clots, strands, membranes, and septa. Fibrin membranes and septa are responsible for pockets or pockets of pleural fluid that may make it difficult to drain fluid from the pleural cavity, and fibrin clots and strands may block drainage tubes.

[0045] Indeed, gross anatomical findings in malignant pleural effusions revealed by transthoracic ultrasound of the pleural cavity showed complex septal effusions in 8.7% of patients, homogeneous echogenic effusions in 15.4% of patients, and complex nonseptal effusions in 65.4% of patients, both of which were likely some combination of blood with cells and fibrinous debris, with anechoic (clear fluid) in only 10.6% of patients.

[0046] To prevent blockage or clogging of the automated pumped fluid management system and to maintain flow through the system, several strategies may be used, alone or in combination. One strategy is to provide multiple fluid inlet passages. Referring to FIG. 4, the first tube 120 may include one or more fluid inlet perforations 170. The fluid inlet perforations 170 may take the form of holes in the wall of the first tube 120 to allow fluid to be drawn into the first tube 120 through the fluid inlet perforations 170 as well as the tube inlet end 150. The fluid inlet perforations 170 may prevent obstruction of flow into the first tube 120 and may improve the capacity or efficiency of fluid drawing into the first tube 120, thereby improving the amount or efficiency of fluid drawn by the automated pumped fluid management system 101. The fluid inlet perforations 170 may also be beneficial by allowing for an alternate fluid inlet location in the event that the tube inlet end 150 or other perforations 170 become blocked, for example, by fibrin clots, fibrin strands or other debris, or apposition of the first tube 120 against the chest wall or lung. The second tube 122 may also include fluid outlet perforations 180.

[0047] An additional or alternative strategy is to construct the first tube 120 to provide a filtering mechanism for bodily fluid entering the automated pumped fluid management system. With reference to FIG. 5, the first tube 120 may include one or more bodily fluid filtration inlet perforations 173. The bodily fluid filtration inlet perforations 173 may take the form of holes in the wall of the first tube 120 to allow bodily fluid to be drawn into the first tube 120. The bodily fluid filtration inlet perforations 173 are sized and shaped such that any fibrinous clots, fibrinous strands or other debris that may pass through the filtration perforations 173 may pass through the entire bodily fluid pathway of the automated pumped filtration fluid management system 102 without blocking or significantly impeding the flow of bodily fluid. Alternatively, the bodily fluid filtration inlet perforations 173 are sized and shaped such that any and all such perforations are smaller than the smallest opening present along the entire bodily fluid pathway of the automated pumped filtration fluid management system 102. Thus, any fibrinous clots, fibrinous strands or other debris that may pass through the fluid filtration inlet perforations 173 will be smaller than the minimum opening of the fluid passageway of the automated pumped filtration fluid management system 102 and therefore will be able to pass through the fluid passageway of the automated pumped filtration fluid management system 102. As shown in FIG. 5, the tube inlet end 150 of the first tube 120 may include a closed end and, in some cases, may be rounded or smoothed to aid in placement of the first tube 120.

[0048] In another additional or alternative potential strategy, as shown in FIG. 6, a fibrinolytic agent coating 190 is provided on at least a portion of the first tube 120 exposed to the pleural fluid. Such a fibrinolytic agent coating 190 can serve to break down fibrin, fibrin clots, fibrin strands, fibrin membranes, fibrin septa, and any other fibrinous debris in the fluid, allowing the fluid to pass through the automated pump-based filtration fluid management system 102. Examples of fibrinolytic agents in the fibrinolytic agent 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.

[0049] In another additional or alternative strategy, as shown in FIG. 7, a fibrin scavenger 192 is provided in at least a portion of the first tube 120 exposed to the pleural fluid. The fibrin scavenger is designed to be placed on the tip of the catheter to convert fibrinogen to fibrin, so that it cannot freely enter the fluid passageways of the automated pumped fluid management system 102 within the pleural fluid. Examples of fibrin scavengers include thrombin, factor XIIIa, surface roughness, surface texture, microfiber, and Dacron. Other fibrin scavengers or other approaches for converting fibrinogen to fibrin can also be used to remove fibrin from the pleural fluid, so that it cannot freely clog the fluid passageways of the automated pumped fluid management system 102 within the pleural fluid.

[0050] In an additional or alternative strategy to prevent clogging, the fluid inlet, the fluid outlet, the first tube, the second tube, or any other aspect of the automated pump-based fluid management system may be coated with an anticoagulant or fibrinolytic agent. For example, components or surfaces of the pump 110, the first tube 120, or the second tube 122 may be coated, at least in part, with an anticoagulant or fibrinolytic agent. The presence of the anticoagulant may reduce the amount of clotting that would occur in the absence of the anticoagulant. Examples of anticoagulants include heparin, low molecular weight heparin, fondaparinux, idraparinux, idrabiotaparinux, diavigatran, rivaroxaban, apixan, betrixaban, edoxaban, darexaban, retaxaban, erivaxaban, hirudin, lepirudin, bivalirudin, argatroban, dabigatran, ximelagatran, hementin, vitamin E, coumarin, warfarin, acenocoumarol, phenprocoumon, atromentin, phenindione, brodifacoum and difenacoum. Examples of fibrinolytic agents include plasmin, tissue plasminogen activator, urokinase, streptokinase, plasminogen activator inhibitor 1 inhibitor and plasminogen activator inhibitor 2 inhibitor. Other examples of anticoagulants or fibrinolytic agents may be used.

[0051] In another additional or alternative potential strategy, to prevent clogging or to address clogging if it does occur, the walls of the automated pump 110 may be constructed with a material that can be pierced with a needle or similar object for injection of, for example, an anticoagulant, fibrinolytic agent, or other suitable material into the interior of the automated pumped fluid management system 100. Alternatively, and as described further below, an access port may be added to the automated pump 110 that also allows for injection of, for example, an anticoagulant, fibrinolytic agent, or other suitable material into the interior of the automated pumped fluid management system 100.

[0052] In an additional or alternative strategy to prevent clogging, patients may be selected based on favorable pleural fluid characteristics that are less likely to clog the system as revealed by transthoracic ultrasound examination of the pleural cavity 220. For example, use of an automated pump-based fluid management system may be limited to patients who present with anechoic (clear fluid) as revealed by transthoracic ultrasound examination of the pleural cavity 220. Other pleural fluid characteristics, such as complex septal effusions, homogeneous echogenic effusions and complex non-septal effusions, or combinations of characteristics, may also be favorable.

[0053] 2. Fluid management system using an automated intercostal pump 8A, a fluid management system 103 using an automatic intercostal pump for placement between a first rib and a second rib generally includes a pump 111, which is a resilient, flexible structure enclosing an interior space and having an inlet 130 and an outlet 132. The automatic intercostal pump 111 may 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 may be a resilient, flexible tube or cylinder made of polyurethane, silicone, polyvinyl chloride, or latex rubber. Alternatively, the pump 111 may be made of a combination of two or more materials, where at least one of the construction materials provides resilience and at least one of the construction materials provides containment of the fluid. For example, pump 111 may be constructed of a resilient nitinol, steel, polyester or other elastic component to provide elasticity and a second bodily fluid containment component such as polyurethane, silicone, polyvinyl chloride, latex rubber, polyethylene terephthalate, nylon, polytetrafluoroethylene, PEBAX (registered trademark: No. 1703062) to provide containment of bodily fluids within pump 111.

[0054] Although the pump 111 is shown as being generally cylindrical, other configurations are possible. In short, the pump 111 may be of any shape to provide adequate compression / decompression and placement in the intercostal region. In particular, it may be desirable to adapt the pump 111 to some degree to the characteristics of a particular region (i.e., shape and / or cavity). In one embodiment, the pump 111 may include flexible silicone tubing. However, the pump 111 may take other forms.

[0055] The automated intercostal pump based fluid management system 103 also includes a first tube 120 and a second tube 122. The inlet 130 and the outlet 132 communicate between the interior and the exterior of the intercostal pump 111, respectively, and are coupled to the first tube 120 and the second tube 122, respectively. In other words, the inlet 130 and the outlet 132 are configured to provide fluid communication between the first tube 120 and the second tube 122, respectively, and the interior space of the intercostal pump 111.

[0056] The first tube 120 includes a tube inlet end 150 and a pump inlet end 140. Generally, the first tube 120 is configured such that the tube inlet end 150 is positioned in a region of the human body from which bodily fluid is to be drained when using the automated intercostal pump based fluid management system 103, while the pump inlet end 140 is coupled to the inlet 130 of the intercostal pump 111. As such, the length of the first tube 120 may vary, as indicated by the length extension 160.

[0057] Similarly, the second tube 122 includes a pump outlet end 142 and a tube outlet end 152. Generally, the second tube 122 is configured such that the tube outlet end 152 is positioned in a region of the body into which bodily fluid is to be drained when using the automated intercostal pump based fluid management system 103, while the pump outlet end 142 is coupled to the outlet 132 of the intercostal pump 111. As such, the length of the second tube 122 may vary, as indicated by the length extension 162.

[0058] Although the first tube 120 and the second tube 122 are shown entering the intercostal pump 111 in a substantially straight line (i.e., perpendicular to the walls of the pump 111), the first tube 120 and the second tube 122 may be configured to enter the intercostal pump 111 at any desired angle. For example, it may be desirable for the first tube 120 and the second tube 122 to each enter and exit the intercostal pump 111 at an angle of about 90 degrees so that the intercostal pump 111 can be more advantageously positioned within the intercostal region. It may also be desirable for the first tube 120 and the second tube 122 to enter and exit at other angles.

[0059] Although tubes 120 and 122 are generally shown as flexible tubes that are easily manipulated and shaped or shaped into any form or orientation, in some embodiments it may be desirable for tubes 120 and 122 to be configured to be somewhat rigid or semi-rigid so that a desired shape or orientation of the tubes is maintained. For example, one of the tubes may be at least partially configured, molded or cast to have a 90 degree bend as it leaves intercostal pump 111. Tubes 120 and 122 may each be configured with a similar 90 degree bend. Alternatively, the tubes may not have a similar bend. As yet another alternative, the tubes may each have other degrees of bend.

[0060] 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 through the fluid inlet perforations 170, as well as through the tube inlet end 150. The fluid inlet perforations 170 may improve the capacity or efficiency of fluid drawing into the first tube 120, and thereby improve the amount or efficiency of fluid drawn by the intercostal pump-based fluid management system 103. The fluid inlet perforations 170 may be particularly beneficial as they allow for an alternative fluid inlet location, especially in cases where the tube inlet end 150 or other perforations are blocked, for example, by fibrin clots, fibrin strands or other debris, or apposition of the first tube 120 against the chest wall or lungs. The second tube 122 may also include a fluid outlet perforation 180.

[0061] With reference to FIG. 8B and the inset cross-sectional view C shown therein, the first tube 120 may include one or more linear body fluid channels 175. Liner body fluid inlet slits 174 on the surface of the first tube 120 open into the linear body fluid channel 175 and allow for the intake of body fluid into the linear body fluid channel 175 of the first tube 120. In combination, these features provide redundancy against clogging of the first tube 120. The linear body fluid inlet slits 174 may be particularly advantageous by allowing near-continuous access to the interior of the first tube 120 along a significant portion of its length such that if a single slit or a portion of the multiple slits is blocked, for example, by fibrin clots, fibrin strands or other debris, or by apposition of the first tube 120 against the chest wall or lungs, the entire first tube 120 may still be able to allow the passage of body fluid therethrough and along its length. Additionally, the linear body fluid intake slits 174 may be sized to limit the size of particulates or debris that may enter the linear body fluid channel 175. This size can be selected to prevent the ingress of particulates or debris large enough to clog the lumen of the linear fluid channel 175 or any other narrowing within the automated intercostal pump based fluid management system 103.

[0062] The automated intercostal pump based fluid management system 103 described with respect to Figures 8A and 8B may additionally or alternatively include any other features, materials or properties described with respect to the automated pump based fluid management system of Figures 4-7.

[0063] 3. Fluid Management System Using Pleuroperitoneal Intercostal Pump 9, there is shown a fluid management system 103 using an automated intercostal pump to provide drainage of fluid from a first region 220 to a second region 230 within a patient's body. In one embodiment, similar to the embodiment shown in FIG 9, fluid is drained from the patient's pleural cavity to the patient's peritoneal cavity. Thus, in such an embodiment, the first region 220 is the patient's pleural cavity and the second region 230 is the patient's peritoneal cavity.

[0064] In one embodiment, the automatic intercostal pump 111 is configured to be at least partially disposed in the intercostal region between two ribs. In other words, when implanted, the intercostal pump 111 extends through the patient's intercostal space, or a portion thereof. Thus, the first tube 120 and, accordingly, the pump inlet 130 are disposed inside the patient's bony thorax. The second tube 122 and, accordingly, the pump outlet 132 are disposed outside the patient's bony thorax. In this manner, the patient 210 will automatically operate (e.g., "pump") the intercostal pump 111 by breathing and corresponding compression / decompression of the bony thorax. The operation of the intercostal pump 111 is further described below.

[0065] 4. Automatic Intercostal Pump a. Design of automatic intercostal pump 10A shows a cross-sectional schematic of the automatic intercostal pump 111 in a generally or substantially uncompressed state with both the inlet one-way valve 320 and the outlet one-way valve 322 (described in further detail below) closed. As noted above, the automatic intercostal pump 111 may generally be a resilient flexible tube or cylinder made of polyurethane, silicone, polyvinyl chloride, latex rubber or other suitable resilient material. Alternatively, the pump 111 may be made of a combination of two or more materials, where at least one of the construction materials provides resilience and at least one of the construction materials provides containment of bodily fluids. For example, the pump 111 may be constructed with a first resilient component, such as resilient Nitinol, steel, polyester or other resilient component, and a second fluid containment component, such as polyurethane, silicone, polyvinyl chloride, latex rubber, polyethylene terephthalate, nylon, polytetrafluoroethylene, PEBAX (registered trademark: No. 1703062), to minimize leakage from within the intercostal pump 111.

[0066] The automated intercostal pump 111 includes pump walls that enclose an interior space 330. For purposes of illustration, the pump walls are shown to include an upper wall 310 and a lower wall 312. The distinction between the upper and lower walls is made for purposes of clarity in describing compression / decompression of the intercostal pump 111 and should not be construed as limiting the intercostal pump 111 to including two distinct pump walls.

[0067] In general, the pump wall 310 (312) may be constructed of any material and any thickness suitable for achieving the desired flexibility and resilience of the intercostal pump 111. The particular 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 intercostal pump 111 (e.g., drainage function). In some embodiments, the pump wall 310 (312) may be made of silicone having an ASTM D2240 Type A durometer of about 30 to about 70 (Young's modulus about 1.15 to about 5.5 MPa), preferably about 40 to about 60 (Young's modulus about 1.7 to about 3.6 MPa), and more preferably about 45 to about 50 (Young's modulus about 2.0 to about 2.5 MPa). In some embodiments, the intercostal pump 111 may include a generally or substantially cylindrical silicone structure having a substantially circular cross-section. The substantially cylindrical silicone structure may have an inner diameter of about 2 to about 14 mm, preferably about 4 to about 10 mm, more preferably about 6 to about 7 mm, an outer diameter of about 3 to about 16 mm, preferably about 6 to about 12 mm, more preferably about 8 to about 10 mm, and a wall thickness of about 0.3 to about 3 mm, preferably about 0.5 to about 2 mm, more preferably about 0.7 to about 1.0 mm. In one embodiment, the substantially cylindrical structure may have an inner diameter of about 6.4 mm and an outer diameter of about 8 mm, with a corresponding wall thickness of about 0.8 mm. In other embodiments, the intercostal pump 111 may include a silicone structure having a substantially elliptical cross section or a substantially rectangular cross section. Other shapes and dimensions may be desirable.

[0068] The intercostal pump 111 further includes an inlet one-way valve 320 and an outlet one-way valve 322. The inlet valve 320 may be located within the interior space 330 of the pump body generally proximate to the inlet 130. The inlet one-way valve 320 may be any suitable one-way valve, for example made of silicone or other suitable material. The inlet one-way valve 320 is configured to prevent or substantially prevent movement of bodily fluid from the interior space 330 of the intercostal pump 111 to the inlet 130. At the same time, the inlet one-way valve 320 is configured to allow movement of bodily fluid from the inlet 130 to the interior space 330 of the intercostal pump 111. In other words, the inlet one-way valve 320 is generally in fluid communication with the inlet 130 to provide one-way movement of bodily fluid from the inlet 130 to the interior space 330 of the intercostal pump 110.

[0069] Accordingly, the outlet one-way valve 322 may be located within the interior space 330 of the pump body generally proximate to the outlet 132. The outlet one-way valve 322 may be any suitable one-way valve, for example made of silicone or other suitable material. The outlet one-way valve 322 is configured to allow movement of bodily fluid from the interior space 330 of the intercostal pump 111 to the outlet 132. At the same time, the outlet one-way valve 322 is configured to prevent or substantially prevent movement of bodily fluid from the outlet 132 to the interior space 330 of the intercostal pump 111. In other words, the outlet one-way valve 322 is in fluid communication with the outlet 132 to provide one-way movement of bodily fluid from the interior space 330 of the intercostal pump 111 to the outlet 132.

[0070] In one embodiment of the intercostal pump 111, an inlet one-way valve frame 340 and an outlet one-way valve frame 342 are added to the outer periphery of the inlet one-way valve 320 and the outlet one-way valve 322, respectively, so that compression / decompression of the intercostal pump 111 does not cause significant compression, deformation or undesirable wear on the inlet one-way valve 320 and the outlet one-way valve 322. The inlet one-way valve frame 340 and the outlet one-way valve frame 342 may be constructed of any relatively rigid or inflexible material for the outer periphery of the inlet one-way valve 320 and the outlet one-way valve 322, respectively. Additionally, the size and shape of the inlet one-way valve frame 340 and the outlet one-way valve frame 342, respectively, may be selected to provide a seam or interconnectable joint between the first tube 120 and the second tube 122 and the upper wall 310 and the lower wall 312 of the intercostal pump 111. Other types of valve frames may be used that are operable such that compression / decompression of the intercostal pump 111 does not cause significant compression, deformation, or undesirable wear to the inlet one-way valve 320 and the outlet one-way valve 322.

[0071] It should be noted that while the inlet one-way valve 320 and the outlet one-way valve 322 are shown as being located within the interior space 330 of the intercostal pump 111, alternative locations for the valves may be desirable. For example, one or both of the inlet one-way valve 320 and the outlet one-way valve 322 may be located outside the pump body, or possibly within the inlet tube 120 and the outlet tube 122, respectively, or may be located between the inlet tube 120 and the pump body, or between the outlet tube 122 and the pump body, respectively. The particular location of the valves is not necessarily important so long as they provide substantially sufficient one-way flow of body fluid into and out of the intercostal pump 111.

[0072] b. Pump operation 10B illustrates a cross-sectional schematic of the intercostal pump 111 in a generally or substantially compressed state. In one embodiment, a first force 350 may be applied to the upper wall 310 to cause the upper wall 310 to recess toward the interior space 330 as shown. In response, a second force 352 may additionally or alternatively be applied to the lower wall 312 to cause the lower wall 312 to recess toward the interior space 330. The recession of the upper and / or lower walls 310 and 312 serves to reduce the volume of the interior space 330 and increase the pressure in the interior space 330. This increase in pressure causes the inlet one-way valve 320 to remain closed and the outlet one-way valve 322 to open, allowing bodily fluid located within the interior space 330 to flow from the interior space 330 through the outlet one-way valve 322 to the second tube 122. For non-compressible bodily fluids, the change in volume that the interior space undergoes in response to the depression of the upper and lower walls 310 and / or 312 is approximately equal to the amount of bodily fluid moving from the interior space 330 through the outlet one-way valve 322. As bodily fluid moves from the interior space 330 through the outlet one-way valve 322, the pressure in the interior space decreases. When the interior pressure is approximately or substantially equal to the pressure at the pump outlet 132, the flow stops and the outlet one-way valve 322 closes, as shown in FIG. 10C.

[0073] As described above, the intercostal pump 111 is substantially resiliently flexible, and therefore, after being placed in a compressed state, as shown in Figures 10B and 10C, when at least one of the first force 350 and the second force 352 is removed, the intercostal pump 111 returns to a non-compressed state, as shown in Figure 10D. As the upper wall 310 returns to a non-compressed state as the first force 350 is removed, and / or the lower wall 312 returns to a non-compressed state as the second force 352 is removed, the volume of the interior space 330 increases and the pressure in the interior space 330 decreases. The pressure within the interior space 330 eventually falls below the pressure within the inlet, opening the inlet one-way valve 320 and allowing the bodily fluid located at the inlet to flow into the interior space 330. In this manner, the intercostal pump 111 generally operates as a pump that draws bodily fluid from the inlet 130 and delivers the bodily fluid to the outlet 132.

[0074] 10E and 10F, the intercostal pump 111 may be configured with a reinforcement 333 integral with or attached to the wall such that a larger volume change occurs in the interior space 330 when at least one of the first force 350 and the second force 352 is applied compared to the volume change of the interior space 330 when the reinforcement 333 is not present, as shown in FIGURES 10A and 10B. This occurs because the reinforcement 333 helps to distribute the relatively narrowly applied first force 350 and second force 352 along a longer length of the upper and lower walls 310 and 312 of the pump, thereby causing a larger change in the interior volume 330 of the pump. Although the stiffener 333 is shown positioned midway along the length of the upper and lower walls 310, 312 so that both ends of the stiffener 333 move together, it is also possible to position the stiffener 333 so that one end of each member is positioned proximate to or even attached to the inlet one-way valve frame 340 or the outlet one-way valve frame 342 so that the stiffener, in turn, acts as a lever arm that provides a greater volume change to the interior space 330 when at least one of the first force 350 and the second force 352 is applied. The stiffener 333 may generally be of any suitable size and shape and may be made of any suitable material, in some cases being generally more rigid than the material forming the upper and lower walls 310, 312.

[0075] During use, the intercostal pump 111 may be compressed as a result of the patient's breathing. More specifically, the intercostal pump 111 may be compressed as a result of the natural movement of the patient's ribs during the respiratory cycle. Additionally, the intercostal pump 111 may be positioned such that the interior space 330 passes between the fibers of the external or internal intercostal muscles and may be compressed as a result of the contraction of these muscle fibers.

[0076] As shown in Figure 11A, the intercostal pump 111, in use, is positioned between a first rib 412 and a second rib 414 selected from the ribs of the chest wall. References herein to the first and second ribs do not necessarily refer to the first and second ribs anatomically, although they may. When the bony thorax expands (during inspiration), the individual ribs 410, 412, 414 and 416 move apart, and in this configuration of the ribs, a relatively small force is applied to the intercostal pump 111. Thus, the intercostal pump 111 is in a generally or substantially uncompressed state.

[0077] 11B, when the bony rib cage contracts (during exhalation), the individual ribs 410, 412, 414, and 416 move toward each other. As a result, a first force 350 and a second force 352, or the first force 350 or the second force 352, are exerted on the intercostal pump 110 by the first rib 412 and the second rib 414, or the first rib 412 or the second rib 414, respectively. Thus, the intercostal pump 111 is generally or substantially in a compressed state.

[0078] An average adult breathes approximately 16 times per minute. Thus, when in use, the intercostal pump 111 may be compressed approximately 16 times per minute, or approximately 23,040 times per day. Of course, this is only an estimate and may vary greatly. The particular compression speed is not necessarily critical to the function of the intercostal pump 111, but the rate at which bodily fluid is pumped will vary with the compression speed and the magnitude of compression (i.e., the degree of rib movement).

[0079] An average adult person exhibits approximately 0.25-3 millimeters of relative movement between the first rib 412 and the second rib 414 throughout the respiratory cycle. Thus, the walls of the intercostal pump 111 may compress approximately 0.25-3 millimeters during each breath. Again, this is of course only an estimate and may vary greatly from patient to patient, and for a particular patient, depending on the particular anatomical position of the first rib 412 and the second rib 414, and the particular longitudinal location of the first rib 412 and the second rib 414 relative to the spine and / or sternum.

[0080] A related consideration is that the ribs are covered by soft tissue, which is itself compressible, and thus the overall range of compressibility of the intercostal pump 111 may be affected if soft tissue is left intact between the intercostal pump 111 and either the first rib 412 or the second rib 414. Therefore, in some cases, it may be desirable to remove soft tissue at the interface between the intercostal pump 111 and either the first rib 412 or the second rib 414.

[0081] Another related consideration is that the ribs generally exhibit relatively cartilaginous portions which themselves may be relatively compressible, and as a result, in some cases, it may be desirable to position the intercostal pump 111 in contact with portions of the first rib 412 and second rib 414 exhibiting relatively small amounts of cartilage (i.e., portions having a relatively large amount of exposed bone as opposed to cartilage).

[0082] Yet another related consideration is that it may be desirable to position the intercostal pump 111 to significantly increase or substantially maximize the amount of surface area of ​​the intercostal pump 111 that contacts the first rib 412 and the second rib 414, respectively. In this manner, the intercostal pump 111 may be subject to greater compression. Thus, it may be desirable to position the intercostal pump 111 substantially parallel to the first rib 412 and the second rib 414, or at any angle between substantially perpendicular and substantially parallel, as opposed to the substantially perpendicular orientation generally shown in Figures 11A and 11B.

[0083] Yet another related consideration is that it may be desirable to size the intercostal pump 111 consistently 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 spaced apart. In this manner, changes in the distance between the first rib 412 and the second rib 414 that occur during breathing may translate into larger volume changes in the intercostal pump 111.

[0084] Yet another related consideration is that it may be desirable to position the intercostal pump 111 relative to the first rib 412 and the second rib 414 such that relative movement of the first rib 412, the second rib 414, other chest wall tissue and / or the lungs causes the intercostal pump 111 to change periodically during breathing, thereby causing the volume of the interior space 330 of the intercostal pump 111 to change periodically with breathing to pump bodily fluids.

[0085] C. Valve structure FIG. 12 shows cross-sectional views of a one-way inlet valve in a closed and open state, and a one-way outlet valve in a closed and open state. In panel A, the inlet one-way valve 320 is shown in a closed state, with the inlet one-way valve frame 340 surrounding and providing structure and support for the inlet one-way valve 320. In panel B, the inlet one-way valve 320 is shown in an open state. The size and shape of the inlet one-way valve frame 340 can be selected to provide a seam or interconnectable fitting for the first tube 120. In panel C, the outlet one-way valve 322 is shown in a closed state, with the outlet one-way valve frame 342 surrounding and providing structure and support for the outlet one-way valve 322. In panel D, the outlet one-way valve 322 is shown in an open state. The size and shape of the inlet one-way valve frame 342 can be selected to provide a seam or interconnectable fitting for the first tube 122.

[0086] For the inlet one-way valve 320, when in the closed position as shown in panel A of FIG. 12, the pressure difference across the valve is pressure P1≦P2+P c(where P1 and P2 are the pressures at the locations shown in panel A, and P c 12, panel B, the pressure difference across the valve is a pressure P c >P1+P2 (where P1 and P2 are the pressures at the locations shown in Panel B, and P c is the cracking pressure of the valve.

[0087] For the outlet one-way valve 322, when in the closed position shown in panel C of FIG. 12, the pressure difference across the valve is P2≦P3+P c where P2 and P3 are the pressures at the locations shown in panel C, and P c 12, panel D, the pressure difference across the valve is P2>P3+P c (where P1 and P2 are the pressures at the locations shown in panel D, and P c is the cracking pressure of the valve.

[0088] In one embodiment, the inlet one-way valve 320 and the outlet one-way valve 322 are formed as duckbill valves having a thin, substantially flat lip that defines a slit that can be moved from a closed position to an open position. In one embodiment, the inlet one-way valve 320 and the outlet one-way valve 322 are configured to operate under a low cracking pressure P such that the valves transition from a closed to an open state with a relatively small pressure differential across the valves. c This cracking pressure P c It requires approximately 25cmH2 to work for most patients. O Less than 15cmH2 O More preferably, less than about 10 cmH2 O Less than or even about 5cmH2 OIn one embodiment, the inlet one-way valve 320 and the outlet one-way valve 322 may have a low reseal pressure so that the valve transitions from an open state to a closed state with a small pressure differential across the valve. This reseal pressure is approximately 15 cmH2 to work with most patients. O Less than 10 cmH2, preferably about 10 cmH2 O More preferably, less than about 5 cmH2 O Less than or even about 2cmH2 O It can also be less than.

[0089] Additionally, in one embodiment, the inlet one-way valve 320 and the outlet one-way valve 322 are configured to undergo minimal deformation when closed and a pressure gradient exists across the valve in the opposite direction to the inlet one-way valve. Specifically, the inlet one-way valve undergoes minimal deformation when a back pressure exists across the valve, i.e., P1≦P2+P c The outlet one-way valve undergoes minimal deformation when there is back pressure across the valve, i.e. P2 ≤ P3 + P c With such a design, the volume change occurring in the pump body interior space 330 is translated nearly or substantially one-to-one into forward flow through the automatic intercostal pump 111. This resistance to deformation can be evaluated as the backflow volume that occurs when backpressure is applied across the sealed or closed inlet one-way valve 320 and outlet one-way valve 322. With an applied backpressure of 50 cmH2O or less, the backflow may be less than about 200 microliters, preferably less than about 100 microliters, more preferably less than about 50 microliters, or even less than about 25 microliters to work with most patients. Thus, the volume pumped forward with each cycle (V forward ) is the change in volume of the internal space 330 of the pump (ΔV internal space ) minus the valve deformation capacity required to reseal the valve (V reseal volume ) or is substantially equal to or equal to the

[0090] V forward = ΔV internal space-V reseal volume A non-limiting example of a valve that may be used for one-way valves 320, 322 is the type described in U.S. Pat. No. 5,261,459, entitled "Miniature Duckbill Valve Having a Low Cracking Pressure and High Flow Rate," which is incorporated herein by reference in its entirety.

[0091] d. Alternative Designs of Pleuroperitoneal Automated Intercostal Pumps Any aspect, feature, characteristic, etc., or combination thereof, of the automated pumped fluid management system described in Figures 1-7 may be incorporated into the automated intercostal pumped fluid management system of Figures 8-12. By way of example, the first tube 120 may be configured to provide a filtering mechanism for fluid entering the automated intercostal pumped fluid management system 104 to prevent blockage or clogging of the automated intercostal pumped fluid management system and to maintain flow through the system. 13, the first tube 120 may include one or more fluid filtration inlet perforations 173. The fluid filtration inlet perforations 173 may take the form of holes in the wall of the first tube 120 to allow fluid to be drawn into the first tube 120. The fluid filtration inlet perforations 173 are sized and shaped such that any fibrinous clots, fibrinous strands or other debris that may pass through the perforations 173 may also pass through the entire fluid pathway of the automated intercostal pumped filtered fluid management system 104 without blocking or significantly impeding the flow of fluid. Alternatively, the fluid filtration inlet perforations 173 are sized and shaped such that any and all such perforations are smaller than the smallest opening present along the entire fluid pathway of the automated intercostal pumped filtered fluid management system 104. For example, the fluid filtration inlet perforations 173 may be sized and shaped to be smaller than the openings of the inlet one-way valve 320 and the outlet one-way valve 322. Thus, any fibrinous clots, fibrinous strands or other debris that may pass through fluid filtration inlet perforations 173 will be smaller than the minimum opening of the fluid passageway of the automated pumped filtration fluid management system 104 and therefore will be able to pass through the fluid passageway of the automated pumped filtration fluid management system 102. As shown in FIG. 13, the tube inlet end of first tube 120 may include a closed end and, in some cases, may be rounded or smoothed to aid in placement of first tube 120.

[0092] It may be beneficial to provide a stable position and orientation of the intercostal pump 111 in the intercostal space between the first and second ribs of the pump. As shown in Fig. 14A, a stability and orientation mechanism 200 is provided, possibly around the intercostal pump, for example proximate the outlet portion of the intercostal pump 111. The stability and orientation mechanism 200 is shown in Fig. 14A as a relatively rounded, generally conical mechanism having a relatively flat surface 201 that is annular or partially annular with respect to the intercostal pump 111 body and oriented at an appropriate angle 203 with respect to the long axis of the intercostal pump 111. In use, as shown in FIGURE 14B, when the intercostal pump 111 is positioned between the first rib 414 and the second rib 416, the flat surface 201 of the stabilization and orientation mechanism 200 interacts with the first rib 414 and the second rib 416 and any soft tissue in between to orient the intercostal pump 111 at a desired angle relative to the chest wall, generally determined by angle 203, and provide stability at this angle and against movement of the intercostal pump along its axis relative to the chest wall. Although shown as being generally rounded and conical, the overall shape of the stabilization and orientation mechanism 200 can be any shape that is essentially useful for orienting the intercostal pump 111 relative to the chest wall and / or providing stability of its orientation relative to the chest wall and / or the axial position of the intercostal pump 111.

[0093] Further embodiments can be constructed to better accommodate the transition between the pleural cavity and the subcutaneous tissue between the skin and the rib cage. As shown in FIG. 15A, a fluid management system 105 with an attached automated intercostal pump includes an attached pump 112 that is approximately or substantially "L-shaped" to better accommodate the transition from the pleural cavity to the subcutaneous tissue. More generally, the attached pump 112 may be shaped with a slope or transition (e.g., between portions 112' and 112'', as described below) that provides a slope transition of the pump 112 of about 1 degree to 179 degrees, preferably about 45 degrees to 135 degrees, more preferably about 75 degrees to 105 degrees, and in some cases approximately about 90 degrees. When positioned in a patient, the intercostal portion 112' of the attached pump 112 is positioned in the intercostal space between the first and second ribs, and the subcutaneous portion 112'' of the pump 112 is positioned below the skin and in the subcutaneous tissue of the outer portion of the bony rib cage. In this configuration and arrangement, as the patient breathes, the intercostal portion 112' of the pump 112 is periodically compressed and decompressed by the first and second ribs, for example as described with respect to FIGS. 11A and 11B, thereby automatically providing a continuous pumping action to the pump and a flow of fluid from the pleural to the peritoneal cavity. Additionally, in this configuration and arrangement, the subcutaneous portion 112'' of the pump 112 is positioned outside the bony rib cage, allowing for periodic (or non-periodic) manual compression between the skin and the rib cage to be utilized which can provide additional pumping action of the pump 112 as needed to supplement the flow of fluid from the pleural to the peritoneal cavity. FIG. 15B is a cross-sectional schematic diagram of the pump 112 of the fluid management system 105 with an attached automatic intercostal pump.

[0094] Another alternative for better conforming to the transition between the pleural cavity and the subcutaneous tissue of the chest wall and providing stable positioning is shown in FIG. 16A. The automated intercostal pump transition fluid management system 106 includes an intercostal pump 113 connected to a transition chamber 701 to better conform to the transition from the pleural cavity to the subcutaneous tissue. The transition chamber 701 is shown as a cylinder with a flat first end 710 of the cylinder, a flat second end 711 on the opposite side of the cylinder from the flat first end 710, and an outlet one-way valve frame 342 integrated into or attached to the wall of the cylinder, with the intercostal pump 113 connected to it. When positioned in a patient, the intercostal pump 113 is positioned in the intercostal space between the first and second ribs, and the transition chamber 701 of the automated intercostal pump transition fluid management system 106 is positioned under the skin and in the subcutaneous tissue of the outer portion of the bony thorax. In this configuration and arrangement, as the patient breathes, the intercostal pump 113 is cyclically compressed and decompressed by the first and second ribs, for example as described with respect to Figures 11A and 11B, thereby automatically providing a continuous pumping action to the pump and a flow of fluid from the pleural cavity to the peritoneal cavity. Additionally, in this configuration and arrangement, the transition chamber 701 is positioned outside the bony thorax and provides a near or substantially 90 degree (or other suitable angle) transition from the pump inlet end 140 of the first tube 120 to the pump outlet end 142 of the second tube 122 to better accommodate the transition from the pleural cavity to the subcutaneous tissue. The flat first end 710 of the cylinder provides a stable interface between the transition chamber 701 and the bony thorax and helps maintain a stable positioning of the intercostal pump 113 in the intercostal space between the first and second ribs. The transition chamber 701 is shown as a flat-ended cylinder, but can be any suitable shape that provides for up to a 90 degree (or other suitable angle) transition from the pump inlet end 140 of the first tube 120 to the pump outlet end 142 of the second tube 122 and stability of the intercostal pump. The transition chamber 701 may be constructed of any relatively rigid or inflexible material, such as nylon, acrylic, polycarbonate, PEEK, ABS, PET, stainless steel, or other suitable material. However, it can also be made of a relatively more flexible material if desired.FIG. 16B shows a cross-sectional schematic of the pump 113 and transition chamber 701 of the fluid management system 106 using a transition automated intercostal pump.

[0095] Another solution to better accommodate and provide stable positioning at the transition between the pleural cavity and the subcutaneous tissue is shown in FIG. 17. In this embodiment, the transition chamber 701 is a rounded diamond-shaped feature that is configured and capable of engaging the bony thorax and helps maintain stable positioning of the intercostal pump 113 in the intercostal space between the first and second ribs and the orientation of the intercostal pump 113 relative to the chest wall, in this case the transition chamber 701 provides an approximately 90 degree (or other suitable angle) transition from the pump inlet end 140 of the first tube 120 to the pump outlet end 142 of the second tube 122 and stability of the intercostal pump. While the approximately 90 degree transition shown in FIG. 17 may be desirable, alternative transition angles are possible, and one such alternative is shown in FIG. 18. Additionally, the general shape of the transition chamber 701 may vary as shown by the flanged mushroom-shaped example shown in FIG. 19. Additional stability features may be provided, such as holes 191 in the flanged mushroom-shaped transition chamber to allow for tissue ingrowth or passage of sutures to secure the automated intercostal pumped transition fluid management system 106 in place. In such cases, the mushroom-shaped flange, or at least a portion thereof, may be configured such that the holes 191 in the flange do not penetrate the interior space 330.

[0096] e. Automatic intercostal pump with manual assist Another automated intercostal pump for accommodating the transition between the pleural cavity and subcutaneous tissue and providing manual assistance to the pumping action is shown in FIG 20A. The transitional fluid management system 107 using an automated intercostal pump with manual assistance includes an intercostal pump 113 connected to a transition chamber 702 to better accommodate the transition from the pleural cavity to the subcutaneous tissue. The transition chamber 702 is shown as a domed cylinder with a flat first end 710 of the cylinder, a domed second end 712 on the opposite side of the cylinder from the flat first end 710, and the intercostal pump 113 connected to an outlet one-way valve frame 342 that is integrated into or attached to the wall of the cylinder. In this embodiment, the transition chamber 702 body and first flat end 710 may be constructed of any relatively rigid or inflexible material, such as nylon, acrylic, polycarbonate, PEEK, ABS, PET, stainless steel, or other suitable material, and the domed second end 712 may be constructed of polyurethane, silicone, polyvinyl chloride, latex rubber, or other suitable resilient material that is deformable but returns to its original 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 under the skin and in the subcutaneous tissue of the outer portion of the bony rib cage. In this configuration and positioning, as the patient breathes, the intercostal pump 113 is cyclically compressed and decompressed by the first and second ribs, for example as described with respect to Figures 11A and 11B, thereby automatically providing a continuous pumping action to the pump and a flow of fluid from the pleural cavity to the peritoneal cavity. Further, in this configuration and arrangement, the transition chamber 702 is positioned outside the bony thorax and provides a maximum 90 degree transition 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 cylindrical flat first end 710 provides a stable interface between the transition chamber 702 and the bony thorax, while the resilient dome-shaped end 712 faces outward from the bony thorax and is positioned beneath the skin in the subcutaneous tissue. The subcutaneous resilient dome-shaped end 712 is thus available for periodic (or non-periodic) manual compression which can provide additional pumping action as needed to supplement the flow of fluid from the pleural cavity to the peritoneal cavity.Additionally, if the material used to make the resilient domed end 712 of the transition chamber 702 is capable of self-sealing after puncture, the interior 330 of the automated intercostal pumped transition fluid management system 107 can be accessed, for example, by passing a needle through the resilient self-sealing material of the domed end 712 to aspirate fluids or inject anticoagulants, fibrinolytics and / or other medications. The body and first flat end of the transition chamber 702 may be constructed of any relatively rigid or inflexible material, although additionally or alternatively, they may be made of a more flexible material if desired. FIG. 20B is a cross-sectional schematic diagram of the pump 113 and transition chamber 702 of the automated intercostal pumped transition fluid management system 107.

[0097] f. Automatic intercostal pump with pleuroperitoneal access port Another automated intercostal pump that accommodates the transition between the pleural cavity and subcutaneous tissue and provides an accessory access port 721 is shown in FIG. 20A. The transition fluid management system 107' using an automated intercostal pump with access port includes an intercostal pump 113 connected to a transition chamber 702 to better accommodate the transition from the pleural cavity to the subcutaneous tissue. The transition chamber 702 is shown as a domed cylinder with a flat first end 710 of the cylinder, a domed second end 712 on the opposite side of the cylinder from the flat first end 710, and the intercostal pump 113 connected to an outlet one-way valve frame 342 integrated into or attached to the wall of the cylinder. The accessory access port 721 is shown as a second domed cylinder with a domed end 722 adjacent the transition chamber 702. In this embodiment, the interior of the accessory access port 721 is in fluid communication with the interior 330 of the transition chamber and, therefore, in fluid communication with the transition chamber 702. In this embodiment, the body of the transition chamber 702, the first flat end 710 of the transition chamber and the cylinder of the accessory access port 721 may be constructed of any relatively rigid or inflexible material, such as nylon, acrylic, polycarbonate, PEEK, ABS, PET, stainless steel, or other suitable material. The domed second end 712 of the transition chamber 702 may be constructed of polyurethane, silicone, polyvinyl chloride, latex rubber, or other suitably resilient material that is deformable and returns to its original shape. The domed septum 722 of the accessory access port 721 may be constructed of certain types of polyurethane, silicone, latex rubber, or other suitable self-sealing material that can be sharply pierced for access but is capable of sealing the puncture. When positioned in the patient, the intercostal pump 113 is positioned in the intercostal space between the first and second ribs, and the transition chamber 702 is positioned under the skin and in the subcutaneous tissue of the outer portion of the bony rib cage. In this configuration and arrangement, as the patient breathes, the intercostal pump 113 is cyclically compressed and decompressed by the first and second ribs, e.g., as described with respect to Figures 11A and 11B, thereby automatically providing a continuous pumping action to the pump and a flow of fluid from the pleural cavity to the peritoneal cavity.Further, in this configuration and arrangement, the transition chamber 702 is positioned outside the bony thorax and provides a maximum 90 degree transition 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 cylindrical flat first end 710 provides a stable interface between the transition chamber 702 and the bony thorax, while the resilient dome-shaped end 712 faces outward from the bony thorax and is positioned beneath the skin in the subcutaneous tissue. The subcutaneous resilient dome-shaped end 712 is thus available for periodic (or non-periodic) manual compression which can provide additional pumping action as needed to supplement the flow of fluid from the pleural cavity to the peritoneal cavity. Additionally, the self-sealing dome-type septum 722 of the accessory access chamber 721 is accessible under the patient's skin by puncturing with a needle, thereby directly connecting to the interior space 330 of the transition chamber 702 and to the outlet side of the inlet valve 320 and the inlet side of the outlet valve 322 for withdrawing contents within the interior space 330 or for injecting anticoagulants, fibrinolytics and / or other agents into the interior space 330 of the transition chamber 702. It should be noted that when withdrawing from the interior space 330, negative pressure may be created during the withdrawal process, which opens the inlet valve 320 and allows bodily fluids to flow out of the pump inlet end 140 of the first tube 120, allowing indirect withdrawal of contents within the first tube 120 as well. Similarly, upon injection of an anticoagulant, fibrinolytic agent and / or other agent into the interior space 330, a positive pressure may be created during the injection process, causing the outlet valve 322 to open and allow bodily fluid to flow into the pump outlet end 142 of the second tube 122 to deliver the anticoagulant, fibrinolytic agent and / or other agent to the contents within the second tube 122. The body and first flat end of the transition chamber 702 may be constructed of any relatively rigid or inflexible material, although additionally or alternatively, they may be made of a more flexible material if desired.

[0098] This concept of using accessory access ports to access the interior of the transition fluid management system with access ported automated intercostal pump 107' can be further utilized by providing multiple access ports. As shown in FIG. 22, for example, the transition chamber 701 is a rounded diamond shaped feature or other suitable shape that can engage with the bony thorax, thereby helping to maintain stable positioning of the intercostal pump 113 in the intercostal space between the first and second ribs and the orientation of the intercostal pump 113 relative to the chest wall. There is a first accessory access chamber 721' with a self-sealing dome-shaped septum 722' in fluid communication with the interior 330 of the transition chamber 701, and a second accessory access chamber (not visible in FIG. 22) with a second self-sealing dome-shaped septum 722'' in fluid communication with the interior 330 of the transition chamber 701. Thus, by traversing the overlying skin and then traversing the first self-sealing dome-type septum 722' of the first accessory access chamber 721', bodily fluids can be selectively withdrawn or anticoagulants, fibrinolytic agents and / or other agents can be selectively injected into the interior space 330 of the transition chamber 702. Similarly, by traversing the overlying skin and then traversing the second self-sealing dome-type septum 722' of the second accessory access chamber, bodily fluids can be selectively withdrawn or anticoagulants, fibrinolytic agents and / or other agents can be selectively injected into the interior of the pump inlet end 140 of the first tube 120.

[0099] g. Design of pleuroperitoneal electromechanical automatic pump 23A , an electromechanical automated pump fluid management system 108 for moving bodily fluid from a first body compartment to a second body compartment generally includes a pump 118 having an inlet 130 and an outlet 132, between which bodily fluid can be moved. The electromechanical automated pump fluid management system 108 also includes a first tube 120 and a second tube 122. The inlet 130 and the outlet 132 are coupled to the first tube 120 and the second tube 122, respectively, in communication between the interior and the exterior of the pump 115. In other words, the inlet 130 and the outlet 132 are configured to provide fluid communication between the first tube 120 and the second tube 122, respectively, and an interior space of the pump 118.

[0100] Additionally, the first tube 120 may include a number of perforations or fenestrations 170 to allow for the entry of bodily fluids into the first tube 120 and into the pump inlet end 140. Generally, the first tube 120 is configured such that, in use, the perforations 170 are located in an area of ​​the human body from which bodily fluids are to be drained, while 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 indicated by the length extension 160.

[0101] Similarly, the second tube 122 includes a pump outlet end 142 and a tube outlet end 152. Generally, the second tube 122 is configured such that the tube outlet end 152 is positioned in an area of ​​the body into which bodily fluid is to be discharged when the automated pump-based fluid management system 108 is in use, while the pump outlet end 142 is coupled to the outlet 132 of the pump 118. The length of the second tube 122 may vary, as indicated by length extension 162.

[0102] 23B is a cross-sectional schematic diagram of the electromechanical automated pump fluid management system 108 in an unactuated state with both the inlet one-way valve 320 and the outlet one-way valve 322 closed. The electromechanical pump 118 includes a pump wall that encloses an interior space 330 with the inlet one-way valve 320 and the outlet one-way valve 322.

[0103] The inlet valve 320 may be located in the interior space 330 of the pump body generally proximate to the inlet 130. The inlet one-way valve 320 may be any suitable one-way valve, such as any one-way valve described herein, and may be made of silicone, for example. The inlet one-way valve 320 is configured to prevent movement of bodily fluid from the interior space 330 of the pump 118 to the inlet 130. At the same time, the inlet one-way valve 320 is configured to allow movement of bodily fluid from the inlet 130 to the interior space 330 of the electromechanical pump 118. In other words, the inlet one-way valve 320 is generally in fluid communication with the inlet 130 to provide one-way movement of bodily fluid from the inlet 130 to the interior space 330 of the electromechanical pump 118.

[0104] Accordingly, the outlet one-way valve 322 may be located in the interior space 330 of the pump body generally proximate to the outlet 132. The outlet one-way valve 322 may be any suitable one-way valve, such as any one-way valve described herein, and may be made of silicone, for example. The outlet one-way valve 322 is configured to allow movement of bodily fluid from the interior space 330 of the electromechanical pump 118 to the outlet 132. At the same time, the outlet one-way valve 322 is configured to prevent or substantially prevent movement of bodily fluid from the outlet 132 to the interior space 330 of the electromechanical pump 118. In other words, the outlet one-way valve 322 is generally in fluid communication with the outlet 132 to provide one-way movement of bodily fluid from the interior space 330 of the electromechanical pump 118 to the outlet 132.

[0105] The inlet one-way valve frame 340 and the outlet one-way valve frame 342 may be integrated into or attached to the body of the electromechanical pump 118 and be external to the inlet one-way valve 320 and the outlet one-way valve 322. Additionally, the size and shape of the inlet one-way valve frame 340 and the outlet one-way valve frame 342 may be selected to provide a seam or interconnectable joint between the first tube 120 and the second tube 122.

[0106] It should be noted that while the inlet and outlet one-way valves 320 and 322 are shown as being located within the interior space 330 of the intercostal pump 118, alternative locations for the valves may be desirable. For example, one or both of the inlet and outlet one-way valves 320 and 322 may be located outside the pump body, or possibly within the inlet and outlet tubes 120 and 122, respectively, or may be located between the inlet and outlet tubes 120 and 122, respectively, and between the pump body and the pump body. The particular location of the valves is not necessarily important so long as they provide substantially sufficient one-way flow of body fluid into and out of the intercostal pump 111.

[0107] In the electromechanical pump 118, a liquid impermeable membrane 550 separates the interior 330, which is in fluid communication with the inlet one-way valve 320 and the outlet one-way valve 322, from a compartment containing the battery 510, the controller 530, and the electromechanical actuator 540. In the electromechanical pump 118, the electromechanical actuator 540 can be a piezoelectric diaphragm connected to the membrane 550 and activated and deactivated by the controller 530, both of which may be powered by the battery 510. As shown in FIG. 23B, the piezoelectric diaphragm 540 is in an unactivated state, and both the inlet one-way valve 320 and the outlet one-way valve 322 are closed. As shown in FIG. 23C, when the controller 530 activates the piezoelectric diaphragm 540, the piezoelectric diaphragm 540 changes shape and deforms the membrane 550 as it strikes the interior 330 of the electromechanical pump 118. This reduces the volume available for bodily fluid in the interior 330, increasing the pressure in the interior 330, opening the outlet one-way valve 322 and moving bodily fluid from the interior 330 of the electromechanical pump 118 to the pump outlet end 142 of the second tube 122 and finally to the tube outlet end 152 of the second tube 122. When the controller 530 deactivates the piezoelectric diaphragm 540, the piezoelectric diaphragm 540 returns to its original shape and the membrane 550 returns to its original shape, as shown in FIG. 23D. This increases the volume available for bodily fluid in the interior 330 of the electromechanical pump 118, decreasing the pressure in the interior 330, causing the outlet one-way valve 322 to close and the inlet one-way valve 320 to open, moving bodily fluid from within the pump inlet end 140 of the first tube 120 to the interior 330 of the electromechanical pump 118. In this manner, bodily fluid is pumped by the cyclic activation and deactivation of the piezoelectric diaphragm 540.

[0108] In the specific situation of recurrent malignant pleural effusions requiring symptom-suppressing treatment, at the end of 12 weeks of daily drainage, 25% of patients have died and 50% of patients have stopped draining fluid because of the realization of pleurodesis in the pleural cavity following repeated drainage [Wahidi MW, Randomized trial of pleural fluid drainage frequency in patients with malignant pleural effusions, AJRCCM, vol. 195, pp. 1050-1057 (2017)]. In other words, a system that can remove effusion from the pleural cavity daily would provide adequate treatment for 75% of patients with malignant pleural effusions. The volume of pleural fluid that must be drained from the pleural cavity can vary greatly from patient to patient and from day to day, and generally the volume of effusion drained decreases with each subsequent drainage. A typical volume of effusion drainage over 12 weeks can start at about 500 ml per day and decrease to about 0 ml per day. The reduction in drainage volume is expressed by the following first-order differential equation: dV / dt=-λV (In the formula, dV is the amount of fluid drained during the small time interval dt, V is the drainage volume, λ is the damping constant) Solving this equation gives an exponential decay of the drainage of the form V(t) = V0e -λt (In the formula, V(t) is the drainage volume on a particular day t, V0 is the drainage volume on day 0) Assuming a starting drainage of 500 ml on day 0 and a decay constant of 1 / 28, after 12 weeks the drainage will be less than 25 ml per day with a total drainage of 13.5 liters. Similarly, if the starting drainage was 1000 ml in excess on day 0, then after 12 weeks the drainage will be less than 50 ml per day with a total drainage of 27.1 liters, assuming the same decay constant of 1 / 28. Thus, designing a system capable of pumping 27 liters of fluid over a 12-week period would meet the drainage requirements of the majority of patients with malignant pleural effusions over that 12-week period, with at least 75% of patients not needing further intervention. The desired daily drainage values ​​based on this relationship or any other desired relationship can be entered into a look-up table used to control the electromechanical pump. By reducing the volume pumped daily over time, the life of the power supply can be extended.

[0109] The amount of work that must be done by the pump to move fluid through the tube from a first location to a second location can be derived from Bernoulli's equation, which is given as follows:

[0110]

number

[0111]

number

[0112]

number

[0113]

number

[0114]

number

[0115]

number

[0116]

number

[0117]

number

[0118]

number

[0119] P1 (intrapleural pressure) = -5cmH2 O = 490 Pa, P2 (intraperitoneal pressure) = +20cmH2 O =1961 Pa, ρ (density of exudate) = 1,000 kg / m 3 , Q2 (average volumetric flow rate of fluid at 100 ml / min at position 2) = 1.667 x 10 -6 m 3 / sec, f (friction coefficient of silicone tube) = 0.5, k (turbulence correction factor) = 1, L (the length of the tube connecting the first and second locations) = 30 cm = 0.3 m, and d(diameter of tube)=3mm=0.003m.

[0120] Substituting these representative example values ​​into the equation, we obtain:

[0121]

number

[0122] To further refine this model, a second friction term is added to the above equation to account for a narrow connection of 1 cm length and 1 mm diameter, resulting in: E pump =2.451+0.0278+5.562+45.05=53.09 Nm / kg Interestingly, a 1 cm long, 1 mm diameter connection contributes 8 times (8X) the frictional energy of a 30 cm long, 3 mm diameter tube. This shows that, using the modified assumptions outlined above including a 1 cm tubing and a 1 mm constriction, 53.09 J of energy is consumed for every kilogram of exudate mass moved from the first patient region 220 to the second patient region 230. Furthermore, for the electromechanical pump 118 operating at 50% efficiency, 106.2 J of energy must be provided to move 1 kg of exudate. Thus, over the first three months, when it is expected that 27 liters of exudate must be moved, it is desirable for the power source to be able to provide a minimum of 2,866.9 J. Additionally, to allow for larger pressure gradients between the first and second patient regions 220, 230, versus higher friction losses in the tubing (especially considering the diameter of the tubing) and lower efficiency, the power source is preferably capable of providing a minimum of about 5,000 J of energy, more preferably a minimum of about 10,000 J of energy, or even about 15,000 J. For reference, an AA battery rated at 2800 mAH and operating at 1.5 V contains 15,120 J of energy.

[0123] Additionally, the diameter of the tubing and connections required to transfer bodily fluids between the first region 220 and the second region 230 is determined by EPump Because of the strong dependence of , it may be desirable for the automated electromechanical pump based fluid management system 108 to have all tubing, connection and opening diameters (regardless of the operation of the one-way valves (e.g., open or closed)) of 1 mm or greater, preferably 2 mm or greater, more preferably 3 mm or greater, or even 4 mm or greater. Alternatively, it may be desirable to limit the length of connections and openings less than 1 mm to lengths of 1 cm or less, preferably 0.5 cm or less, and more preferably 0.2 cm or less.

[0124] The activation and operation of the electromechanical pump 118 may be optimized based on the fluid transfer requirements between the first region 220 and the second region 230 of the patient. For the pleural to peritoneal cavity outlined above, the exudate transfer requirements may be 500 ml on day 1, decreasing over time to less than 25 ml by day 84, or 1 liter on day 1, decreasing over time to less than 50 ml by day 84. In such a situation, the required amount of fluid may be pumped on day 1 and then calculated based on, for example, the following relationship: V(t) = V0e -λt (In the formula, V0 is (as an example) 1 liter, λ is 1 / 28, t is the number of days after implantation) The controller 530 can be programmed to turn on the pump for a period of time based on the pump's throughput, followed by a reduction in the amount of time the pump is on each subsequent day.

[0125] Alternatively, the pump on time can be based on a look-up table implemented with the desired daily fluid output. The electromechanical pump 118 may be turned on once per day to pump the entire fluid requirement at once, or the total pump on time may be split throughout the day. For example, the electromechanical pump 118 may be turned on once per hour to pump approximately 1 / 24 of the total desired daily fluid output. Other patterns of pump on and pump off times may also be used.

[0126] Additionally, the controller 530 can be designed with a detection mechanism that can monitor the flow of bodily fluid when the electromechanical pump 118 is on, and can turn off the electromechanical pump 118 if the flow of bodily fluid stops. For example, if the initial estimated or desired amount for the first day is 1 liter, but the flow stops after 550 ml of bodily fluid is pumped, the controller 530 can be programmed to stop the electromechanical pump 118. Alternatively, the electromechanical pump 118 can simply be turned on every hour, or other suitable time, and remain on until the flow of bodily fluid falls 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 detection mechanism that can monitor the pressure inside the electromechanical pump 118 while the electromechanical pump 118 is on, and can be programmed to turn off the electromechanical pump 118 if the pressure inside the pump falls below a predetermined value. For example, the controller may turn off the electromechanical pump 118 when the pressure drops below about 5 cmH2O, below about 0 cmH2O, below about -5 cmH2O, below about -10 cmH2O, or below about -20 cmH2O.

[0127] In the electromechanical pump 118, the electromechanical actuator 540 has been described as a piezoelectric diaphragm, however, alternative actuators for diaphragm pumps, such as, but not limited to, electric motors and cams, among other alternatives, can be used to achieve similar operation. Indeed, the electromechanical pump 118 can be a gear pump, a screw pump, a rotary vane pump, a diaphragm pump, a piezoelectric diaphragm pump, a plunger pump, a peristaltic pump, a lobe pump, a piston pump, a centrifugal pump, or any other type of pump.

[0128] h. Design of pleuroperitoneal electromechanical automatic intercostal pump 24A and 24B, a combination electromechanical automated intercostal pump based fluid management system 109 is shown incorporating an intercostal pump 113, operating as described, for example, with respect to FIGS. 11A and 11B, and an electromechanical pump 118, for example, as described, for example, with respect to FIGS. 23A-23D. The pumps may share a common interior 330, an inlet one-way valve 320, and an outlet one-way valve 322. In operation, the intercostal pump 113 may be cyclically compressed and decompressed between the first and second ribs to create a continuous flow of fluid between the pump inlet 130 and the pump outlet 132. The electromechanical pump 118 may be configured to supplement the flow of fluid as needed.

[0129] 5. Fluid management systems using other automated pumps Fluid management systems including automated pump 110 may be used to transport and drain fluids in various regions of a patient's body, that is, the fluid management systems including intercostal pumps described herein are not limited to use with respect to draining fluids from a patient's pleural cavity to the patient's peritoneal cavity.

[0130] One example of an alternative use of a fluid management system incorporating an intercostal pump as described herein is the drainage of fluid from the cerebrospinal region of a patient. In accordance with this alternative use, the tube 120 may be configured to extend from the automated pump 110 to the cerebrospinal region of the patient such that the tube inlet end 150 is disposed at the cerebrospinal region of the patient. In this manner, excess cerebrospinal fluid may be drained.

[0131] Another example of an alternative use of a fluid management system incorporating an intercostal pump as described herein is the drainage of fluid from the pericardial region of a patient. Other alternative uses are of course possible. In general, the fluid management systems incorporating the intercostal pumps described herein may be used to transport and remove fluid from any combination of regions within a patient's body that can be sufficiently fluidly communicated with any of the automated intercostal pump-based fluid management systems 100 described herein.

[0132] 6. Fluid management system with reservoir and automatic pump 25, an automated intercostal pump based fluid management system 1000 is shown having at least a portion of a pump 1010 implanted within the patient's body 200, a first tube 120 and at least a portion of a second tube 122 implanted outside the patient's body, that provides for drainage of bodily 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, bodily fluid is drained from the patient's pleural cavity 220 to the external reservoir 1020, similar to the example embodiment shown in FIG.

[0133] In one embodiment, the automatic intercostal pump 1010 is configured to be at least partially disposed in the intercostal region between two ribs. In other words, when implanted, the intercostal pump 1010 extends through the patient's intercostal space, or a portion thereof. Thus, the first tube 120 and, accordingly, the pump inlet 130 are disposed inside the patient's bony thorax. The second tube 122 and, accordingly, the pump outlet 132 are disposed outside the patient's bony thorax. In this manner, the patient 210 will automatically operate (e.g., "pump") the intercostal pump 1010 by breathing and corresponding compression / decompression of the bony thorax. This configuration allows the patient to move around with minimal hardware while fluid in the pleural space is actively drained.

[0134] 7. A method for draining fluid from within a patient's body using an automated pump-based fluid management system A method for draining fluid from a first region of a patient or human body to a second region of the patient or human body may generally be performed using any of the various automated pump-based fluid management systems described herein. With reference to FIG. 26A and method 800, for an example method for draining pleural fluid, in step 802, an intercostal pump (e.g., 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 intercostal space of the patient such that the pump is compressed between a first rib (e.g., 412) and a second rib (e.g., 414). The intercostal pump (e.g., 110, 111, 112, etc.) may be implanted using any suitable known or unknown surgical technique. In step 804, fluid communication is established between the first region of the patient and an inlet 130 of the intercostal pump (e.g., 110, 111, 112, etc.). For example, a first tube (e.g., 120) may be extended from the pleural cavity of the patient to the inlet 130. At step 806, fluid communication is established between the second region of the patient and the outlet 132 of the intercostal pump (e.g., 110, 111, 112, etc.). For example, a second tube (e.g., 122) may extend from the outlet 132 to the peritoneal cavity of the patient. At step 808, the intercostal pump (e.g., 110, 111, 112, etc.) is periodically compressed and electromechanically pumped or periodically compressed or electromechanically pumped to move bodily fluid through the intercostal pump from the first region of the patient via the first tube and into the second region of the patient via the second tube, depending on which of the various embodiments described above is used.

[0135] For example, an intercostal pump (e.g., 110, 111, 112, etc.) may be compressed between a first rib (e.g., 412) and a second rib (e.g., 414) during a patient's respiratory cycle. Specifically, with reference to FIG. 26B and method 850, at step 852, the intercostal pump (e.g., 110, 111, 112, etc.) is decompressed. For example, the intercostal pump (e.g., 110, 111, 112, etc.) is 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 is already exhaling). When the patient inhales, the bony thorax expands and the first rib 412 and the second rib 414 move away from each other. As a result, the intercostal pump (e.g., 110, 111, 112, etc.) is decompressed. In step 854, the intercostal pumps (e.g., 110, 111, 112, etc.) draw in bodily fluid. That is, as a result of depressurizing the intercostal pumps (e.g., 110, 111, 112, etc.) in step 852, bodily fluid is drawn into the interior space (e.g., 330) of the intercostal pumps (e.g., 110, 111, 112, etc.) by the pumping force. In step 856, the intercostal pumps (e.g., 110, 111, 112, etc.) are compressed. For example, the intercostal pumps (e.g., 110, 111, 112, etc.) are compressed between the first rib 412 and the second rib 414 as a result of the patient's bony rib contracting (i.e., the patient exhales). When the patient exhales, the bony rib contracts and the first rib 412 and the second rib 414 move toward each other. As a result, the intercostal pump (e.g., 110, 111, 112, etc.) is compressed. In step 858, the intercostal pump (e.g., 110, 111, 112, etc.) expels bodily fluid. That is, in step 856, as a result of compressing the intercostal pump (e.g., 110, 111, 112, etc.), a pumping force expels bodily fluid out of the interior space (e.g., 330) of the intercostal pump (e.g., 110, 111, 112, etc.). In some methods, an electromechanical pump (e.g., 118) may be used instead of or in addition to the intercostal pump (e.g., 110, 111, 112, etc.).

[0136] 8.Other As used herein, the terms "substantially" or "approximately" refer to the complete or nearly complete extent or degree of an action, feature, characteristic, state, structure, item, or result. For example, an object that is "substantially" or "approximately" enclosed means an object that is completely enclosed or nearly completely enclosed. The exact tolerance from absolute completeness may vary depending on the particular context. Generally speaking, however, the proximity to completeness is such that it will produce approximately the same overall effect or result as if absolute and total completeness had been obtained. The use of "substantially" or "approximately" applies equally when used in a negative sense to refer to a complete or nearly complete lack of an action, feature, characteristic, state, structure, item, or result.

[0137] Unless otherwise indicated, as used herein, the phrases "at least one of [X] and [Y]" or "at least one of [X] or [Y]" mean that, where [X] and [Y] are different components that may be included in an embodiment of the disclosure, the embodiment can include component [X] without component [Y], the embodiment can include component [Y] without component [X], or the embodiment can include both components [X] and [Y]. Similarly, when used with respect to three or more components, such as "at least one of [X], [Y], and [Z]" or "at least one of [X], [Y], or [Z]," these phrases mean that the embodiment can include any one of the three or more components, any combination or subcombination of the components, or all of the components.

[0138] Examples of embodiments of a fluid management system using an automatic pump are described above. They 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 above teachings. The various embodiments have been chosen and described in order to provide the best illustration of the principles of the disclosure and their practical application, and to enable those skilled in the art to utilize the various embodiments with various modifications suited to the particular use contemplated. All such modifications and variations are within the scope of the disclosure, as determined by the appended claims, when interpreted in accordance with the breadth to which they are fairly, legally, and equitably entitled.

Claims

1. a pump body having an interior chamber in fluid communication with an inlet and an outlet; an inlet one-way valve generally proximate the inlet configured to permit movement of bodily fluid from the inlet to the internal chamber and at least substantially prevent movement of bodily fluid from the internal chamber to the inlet; an outlet one-way valve generally proximate the outlet configured to permit movement of bodily fluid from the internal chamber to the outlet and to at least substantially prevent movement of bodily fluid from the outlet to the internal chamber; a first tube extending from the inlet and configured to allow transfer of bodily fluid from a first region of the patient's body to the inlet; a second tube extending from the outlet and configured to allow transfer of bodily fluid from the outlet to a second region of the patient's body; A pump-based body fluid management system comprising: At least one of the inlet one-way valve and the outlet one-way valve has a pressure of 15 cmH ２ configured to reseal at a back pressure differential of less than O; The pump body includes: an orientation mechanism configured to couple with at least one rib of a patient-user when the pump body is implanted between adjacent ribs of the patient-user and configured to orient the pump body at a desired angle relative to the at least one rib; a transition portion angling a first portion of the pump body including the inlet relative to a second portion of the pump body including the outlet; 1. A pump-based fluid management system comprising at least one of:

2. A back pressure differential for resealing at least one of the inlet one-way valve and the outlet one-way valve is 5 cmH ２ 10. The pump-based body fluid management system of claim 1, wherein the axial length of the pump is less than 10 mm.

3. 50 cmH applied to the inlet or outlet one-way valve ２ 10. The pump-based fluid management system of claim 1, wherein in response to O back pressure, the inlet one-way valve or the outlet one-way valve undergoes a deformation that results in less than 200 microliters of backflow.

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

5. 5. The body fluid management system using a pump according to claim 4, wherein the inner diameter is between 6 mm and 7 mm, and the outer diameter is between 8 mm and 10 mm.

6. The pump-based fluid management system of any one of claims 1 to 5, wherein said at least a portion of said pump body comprises a wall thickness of between 0.7 mm and 1.0 mm.

7. 6. A pump-based fluid management system according to any one of claims 1 to 5, wherein the pump body includes at least one stiffener integrated with or attached to a wall of the pump body and configured to distribute forces applied to the wall along a length of the wall.

8. The body fluid management system using a pump according to any one of claims 1 to 5, wherein at least a portion of the pump body is constructed from a self-sealing material.

9. The pump-based fluid management system of any one of claims 1 to 5, further comprising an accessory access port in fluid communication with the internal chamber.

10. A fluid management system using the pump described in claim 9, wherein the accessory access port includes a self-sealing material.

11. A pump-based fluid management system according to any one of claims 1 to 5, wherein at least a portion of at least one of the pump body, the first tube or the second tube is coated with at least one of an anticoagulant or a fibrinolytic factor.

12. The pump-based fluid management system of claim 11 , wherein at least a portion of at least one of the pump body, the first tube, or the second tube is coated with heparin.

13. The pump-based fluid management system of claim 12, wherein at least a portion of the pump body is coated with heparin.

14. The pump body is constructed of a resilient, flexible material selected such that, when implanted between adjacent ribs of the patient, expansion and contraction of the patient's bony thorax causes decompression and compression, respectively, of the pump body and automatic pumping of bodily fluids received at the inlet and out through the pump body at the outlet; 6. A fluid management system using a pump as described in any one of claims 1 to 5, wherein the pump body further comprises a manually depressible portion constructed of a deformable material that returns to its original shape after deformation, the manually depressible portion being configured to face outward from the patient's bony thorax when the pump body is implanted between adjacent ribs of the patient, the manually depressible portion being further configured to pump fluid from the internal chamber to the outlet.

15. A body fluid management system using the pump described in claim 14, wherein the manually depressable portion includes an approximately dome-shaped portion of the pump body.

16. A body fluid management system using the pump described in claim 15, wherein the approximately dome-shaped portion is constructed of a self-sealing material.

17. a pump body having an interior chamber in fluid communication with an inlet and an outlet; an inlet one-way valve generally proximate the inlet configured to permit movement of bodily fluid from the inlet to the internal chamber and at least substantially prevent movement of bodily fluid from the internal chamber to the inlet; an outlet one-way valve generally proximate the outlet configured to permit movement of bodily fluid from the internal chamber to the outlet and to at least substantially prevent movement of bodily fluid from the outlet to the internal chamber; A pump-based body fluid management system comprising: said pump body being constructed of a resiliently flexible material selected such that, when implanted between adjacent ribs of a patient-user, expansion and contraction of the patient-user's bony thorax cause respective decompression and compression of said pump body and automatic pumping of bodily fluids through said pump body and received at said inlet and out of said outlet; 1. A pump-based fluid management system, comprising: a manually depressible portion, the pump body being constructed from a deformable material that returns to its original shape after deformation, the manually depressible portion being configured to face outwardly from the patient-user's bony thorax when the pump body is implanted between adjacent ribs of the patient-user, the manually depressible portion being further configured to pump bodily fluid from the internal chamber to the outlet.

18. 20. The pump-based fluid management system of claim 17, wherein the manually depressible portion comprises a generally dome-shaped portion of the pump body.

19. 20. The pump-based fluid management system of claim 18, wherein said generally dome-shaped portion is constructed from a self-sealing material.

20. A first tube extending from the inlet and configured to allow movement of bodily fluid from a first region of the patient-user's body to the inlet; a second tube extending from the outlet and configured to allow transfer of bodily fluid from the outlet to a second region of the patient-user's body; 20. The pump-based fluid management system of claim 17, further comprising:

21. The pump-based fluid management system of claim 17, wherein at least one of the inlet one-way valve and the outlet one-way valve are configured to reseal at a backpressure differential of less than 15 cm H2O.

22. The pump-based fluid management system of claim 21, wherein at least one of the inlet one-way valve and the outlet one-way valve are configured to reseal at a backpressure differential of less than 5 cm H2O.

23. A fluid management system using a pump as described in claim 21, wherein in response to a back pressure of 50 cmH2O applied to the inlet one-way valve or the outlet one-way valve, the inlet one-way valve or the outlet one-way valve undergoes a deformation such that backflow is less than 200 microliters.

24. A body fluid management system using the pump described in claim 17, wherein at least a portion of the pump body includes a substantially circular cross-section having an inner diameter of 4 mm to 10 mm and an outer diameter of 6 mm to 12 mm.

25. A body fluid management system using the pump described in claim 24, wherein the inner diameter is 6 mm to 7 mm and the outer diameter is 8 mm to 10 mm.

26. A fluid management system using the pump of claim 24, wherein at least a portion of the pump body has a wall thickness of 0.7 mm to 1.0 mm.

27. ​​A fluid management system using the pump of claim 17, wherein the pump body includes at least one stiffener integrated with or attached to a wall of the pump body and configured to distribute forces applied to the wall along the length of the wall.

28. A body fluid management system using the pump described in claim 17, wherein at least a portion of the pump body is constructed of a self-sealing material.

29. A fluid management system using the pump of claim 17, further comprising an accessory access port in fluid communication with the internal chamber.

30. A fluid management system using the pump of claim 29, wherein the accessory access port comprises a self-sealing material.

31. 21. The pump-based fluid management system of claim 20, wherein at least a portion of at least one of the pump body, the first tube, and the second tube is coated with at least one of an anticoagulant or a fibrinolytic agent.

32. 21. The pump-based fluid management system of claim 20, wherein at least a portion of at least one of the pump body, the first tube, and the second tube is coated with heparin.

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