Fluid management system using electromechanical pump

Abstract

To provide a fluid management system using a novel electromechanical pump.SOLUTION: A fluid management system using an electromechanical pump includes: an electromechanical pump in fluid communication with an inlet and an outlet; a first tube that extends from the inlet and configured to allow body fluid to move from a first region of a patient's body to the inlet; and a second tube which extends from the outlet and is configured to allow the body fluid to move into a second region of the patient's body from the outlet. The electromechanical pump includes: an actuator capable of moving the body fluid from the inlet to the outlet; a controller which is operably coupled to the actuator and is capable of controlling the actuator; and a battery which is operably coupled to the controller and provides the controller and the actuator with energy.SELECTED DRAWING: Figure 24B

Description

Technical Field

[0001] The present disclosure relates to a body fluid management system using an electromechanical pump.

Background Art

[0002] Many methods for draining body fluids involve using a pump in combination with a shunt or catheter to drain body fluids from one cavity within the human body to either another cavity within the body or a reservoir outside the body. Such methods may be utilized, inter alia, for purposes including, for example, draining a patient's blood, urine, saliva, cerebrospinal fluid, peritoneal fluid, and / or pleural fluid.

[0003] One application of drainage technology is the drainage of pleural fluid for the treatment of pleural effusion. Pleural fluid is a low-protein fluid that is typically present in relatively small amounts (usually 10 to 20 milliliters) in each of a patient's pleural cavities. The pleural cavity is the space between the visceral pleura (i.e., the membrane that lies over the entire outer surface of each lung) and the parietal pleura (i.e., the membrane that covers the inside of the chest wall of each hemithorax). The small amount of pleural fluid within each pleural cavity spreads very thinly between the visceral pleura and the parietal pleura, thereby providing a large surface tension that mechanically couples the lungs to the chest wall while simultaneously lubricating these surfaces and allowing the lungs to slide over the chest wall during the breathing process. In a normal healthy person, pleural fluid is constantly produced mainly from the leakage of body fluids from blood vessels and lymphatic vessels within the visceral pleura that covers the outer surface of the lungs and is essentially reabsorbed at the same rate by lymphatic vessels located within the parietal pleura that covers the chest wall. This dynamic equilibrium results in the body fluid being exchanged multiple times a day, maintaining a small total volume in the range of 10 to 20 milliliters. However, in certain abnormal conditions, especially infections, inflammations, malignancies, heart failure, liver failure, or kidney failure, the net flow of pleural fluid within the pleural cavity becomes unbalanced due to an increase in body fluid production, a decrease in reabsorption, or both, resulting in an excessive accumulation of body fluid within the pleural cavity (e.g., on the order of several hundred milliliters to several liters).

[0004] Excessive accumulation of pleural effusion, known as hydrothorax, can add additional mass that must be moved with each breath and cause pathological compression of lung tissue, which can significantly complicate or impede the breathing process. This can result in, for example, dyspnea, shortness of breath, chest pain, and / or chronic cough, and can greatly impair the patient's quality of life.

[0005] Currently in the United States, approximately 1.5 million new patients suffer from pleural effusion each year. Many of these exudates are chronic, recur after drainage, are highly symptomatic, and can debilitate patients. One common type of recurrent symptomatic pleural effusion is due to malignancy. In the United States, over 200,000 malignant pleural effusions occur each year, and more than half of these malignant pleural effusion patients experience recurrent symptoms directly caused by the patient's exudate.

[0006] Treatment options for recurrent symptomatic pleural effusion can be divided into 1) repeated drainage of pleural effusion and 2) pleural cavity removal. One approach to treating recurrent symptomatic pleural effusion is to repeat therapeutic thoracentesis. Thoracentesis involves inserting a needle and catheter device into the pleural cavity, removing the needle at that point, and leaving the catheter in the pleural cavity. The catheter remains in place and functions as a drainage tube that allows excess pleural effusion to be moved from the pleural cavity to an external collection reservoir. This procedure usually significantly improves symptoms. Unfortunately, malignant exudates are likely to recur after drainage, and therapeutic thoracentesis must be frequently repeated to suppress symptoms. However, due to delays in the patient informing the physician of symptom recurrence and delays in the construction and provision of repeated thoracentesis, patients often spend a significant portion of their lives with exudate-related symptoms. Additionally, thoracentesis is painful and uncomfortable, and otherwise often involves complications such as frequent pneumothorax (i.e., lung collapse due to air accumulation in the pleural cavity) and severe bleeding or infections.

[0007] Another treatment option is pleurodesis. Pleurodesis is the closure of the pleural cavity by injection of a sclerosing agent into the pleural cavity and the adhesion of the visceral pleural surface to the parietal pleural surface. 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 pleural effusion, similar to the drainage achieved by thoracentesis. After drainage of the pleural effusion, the sclerosing agent is injected into the pleural cavity through the tube to completely coat these membranes, permanently adhering the visceral and parietal membranes to each other and closing and eliminating the pleural cavity. Thoracic tube pleurodesis may lead to long-term control of exudate-related symptoms. Unfortunately, thoracic tube pleurodesis usually requires hospitalization for at least 2 days and up to 7 days, may be associated with significant pain, may lead to dyspnea related to pleurodesis, and up to one-third of patients may not achieve symptom relief for more than a few weeks.

[0008] Another variation of pleurodesis is video-assisted thoracoscopic pleurodesis, which involves inserting a telescope into the patient's chest through an intercostal incision on the patient's side. The pleural fluid is drained, a detailed examination of the pleural cavity is performed, and the sclerosing agent is more carefully applied to the identified abnormal areas. In some cases, video-assisted thoracoscopic pleurodesis can achieve better results than thoracic tube pleurodesis. Unfortunately, video-assisted thoracoscopic pleurodesis also usually requires long-term hospitalization of 4 to 7 days, may be associated with significant pain, may lead to dyspnea related to pleurodesis, and many patients may not achieve symptom relief for more than a few weeks.

[0009] Yet another treatment option is a chronic indwelling pleural catheter. Such an indwelling catheter is permanently placed within a patient and allows the patient to intermittently but continuously drain pleural fluid into an external reservoir. That is, one end of the pleural catheter is placed within the affected pleural cavity within the patient's body, and the other end of the catheter extends outside the patient's body and remains exposed externally for extended periods of time. Chronic indwelling catheters have been shown to provide a relatively high success rate in the management of exudate-related symptoms, and the associated patient hospital stay is relatively short, approximately one day. However, because the catheter passes through the patient's skin with part inside the body and part outside, a significant percentage of patients (about eight percent) are invaded by infectious diseases. Additionally, patients experience discomfort, irritation, and nuisance from the exposed indwelling catheter. Finally, to relieve exudate-related symptoms, the patient or the patient's caregiver must actively access the external portion of the catheter, connect the catheter to an external reservoir, and drain the exudate from the pleural cavity into the reservoir.

[0010] Yet another approach is the pleuroperitoneal shunt. A pleuroperitoneal shunt provides a permanent conduit between the pleural cavity and the peritoneal cavity or abdomen, enabling the movement of body fluid from the pleural cavity to the peritoneal cavity, as opposed to an external reservoir. Once in the peritoneal cavity, the body fluid is reabsorbed into the patient's bloodstream through blood vessels and lymphatics located in the abdomen. In a typical pleuroperitoneal shunt, there is a pumping chamber that the patient or caregiver must manually activate to move the pleural fluid. The pleuroperitoneal shunt passes subcutaneously from the chest to the abdomen, along with a pumping chamber that is in a subcutaneous pocket covering the bony thorax. The pleuroperitoneal shunt, like chronic indwelling catheters, has been shown to have a relatively high success rate in the management of effusion-related symptoms, and the associated patient hospital stay is relatively short, about one day. However, as with chronic indwelling catheters, a significant percentage of patients (about 4 percent) are invaded by infections. Further drawbacks of conventional pleuroperitoneal shunts include a relatively high rate of shunt-specific complications such as the coagulation of body fluid within the shunt. Finally, to relieve effusion-related symptoms, the patient or the patient's caregiver must repeatedly and actively compress the pumping chamber multiple times to transfer the effusion from the pleural cavity to the peritoneal cavity, which causes significant discomfort and inconvenience.

[0011] There are other applications of drainage techniques. These include, but are not limited to, the drainage of pericardial fluid, cerebrospinal fluid, peritoneal fluid, urine, bile, and lymphatic fluid. The cavities into which these body fluids can be drained include, but are not limited to, the pleural cavity, peritoneal cavity, bile duct, stomach, lymphatic vessels including the thoracic duct, veins including the large veins, and the bladder.

[0012] The background description provided herein is intended to generally present the context of the present disclosure. At the present time, the research of the inventors named herein, to the extent described in this background art section, is not admitted to be prior art to the present disclosure, either expressly or implicitly, with respect to aspects of this disclosure that are not admitted to be prior art at the time of filing, together with aspects of this disclosure. SUMMARY OF THE INVENTION

[0013] There is a need for a new technique for draining pleural fluid to provide a high success rate in the treatment of pleural effusion, avoid a high rate of infections and other complications, and relieve symptoms without the need for either or both a long patient hospital stay and repeated clinic visits, and without the inconvenient need to manually compress the pumping chamber multiple times daily or the inconvenient need to physically connect a catheter to an external reservoir. The automatic pump-based body fluid management system described herein provides such a new and beneficial drainage technique.

[0014] The body fluid management system using an automatic 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 a first valve at an outlet from the pumping chamber. The volume of the pumping chamber that contacts the body fluid is variable. The inlet is attached to a first tube that extends from the automatic 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 that extends from the automatic pump to a second region of the patient's body. The second region of the patient's body may be, for example, the patient's peritoneal cavity. By the operation of the automatic pump, the body fluid is transferred from the first region of the patient's body to the second region.

[0015] In one embodiment, the pumping chamber of the automatic pump is an elastic flexible tube, and the pumping chamber is disposed between the first rib and the second rib of the patient. (It should be noted that such use does not necessarily refer to two specific ribs, for example, the "first" and "second" ribs that are usually referred to as the two ribs closest to the patient's skull in an anatomical context.) The automatic pump operates by continuously compressing and decompressing the pumping chamber between the first rib and the second rib when the patient breathes. When the patient inhales, the patient's bony thorax expands, the intercostal space (i.e., the space between the first rib and the second rib) increases, and the pumping chamber is decompressed. When the patient exhales, the patient's bony thorax 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.

[0016] In another embodiment, the pumping chamber of the automatic pump is an elastic, elongated, flexible tube with a portion of the pumping chamber disposed between the patient's first and second ribs 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. One is by continuously compressing and decompressing the pumping chamber between the first and second ribs as the patient breathes, thereby periodically changing the volume of the pumping chamber. The other is by manually compressing a portion of the elongated pumping chamber disposed between the patient's bony thorax and the patient's skin by the patient or a caregiver. Thus, when the patient inhales, a portion of the pumping chamber disposed between the first and second ribs is decompressed, and when the patient exhales, a portion of the pumping chamber is compressed, thereby providing automatic pumping. Further, if it is determined based on the patient's symptoms, radiography, or ultrasonography that there is excessive effusion in the pleural cavity, the patient or the patient's caregiver can potentially repeatedly manually compress a portion of the pumping chamber between their finger or hand and the bony thorax to provide additional pumping action.

[0017] In yet another embodiment, the pumping chamber of the automatic pump comprises a first portion constituted by an elastic flexible tube disposed between the patient's first and second ribs, and a second portion constituted by a semi-rigid chamber with an electromechanical pump capable of assisting the pumping operation provided by the first portion. Thereby, the automatic pump can operate first by continuously compressing and decompressing the first portion of the pumping chamber between the first and second ribs when the patient breathes, thereby periodically changing the volume of the pumping chamber, and 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 inhales, the first portion of the pumping chamber disposed between the first and second ribs is decompressed and filled with exudate from the pleural cavity, and when the patient exhales, the first portion of the pumping chamber is compressed to push body fluid from the pumping chamber into the peritoneal cavity. The electromechanical pump of the second portion can also pump body fluid from the pleural cavity to the peritoneal cavity independently of the operation of the pumping chamber disposed between the first and second ribs The use of the automatic pump described herein avoids certain drawbacks of known body fluid drainage techniques. For example, an intercostal pump operates to drain body fluid periodically, continuously, and automatically without the patient having to manually compress the pump using the hands or the patient having to drain body fluid outside the patient's body. Further, improved performance may be achieved by reducing the occurrence of clotting observed in other body fluid drainage systems that may remain inoperative for long periods of time due to the continuous operation of the intercostal pump.

[0018] The foregoing provides a simplified overview of such embodiments in order to provide a basic understanding of one or more embodiments of the present disclosure. This overview is not an extensive overall view of all contemplated embodiments, nor does it identify key or critical elements of all embodiments, nor does it detail the scope of all or part of the embodiments. Other embodiments of the present disclosure will be apparent to those skilled in the art from the following detailed description, which illustrates exemplary embodiments of the invention. As will be understood, the various embodiments of the present disclosure are capable of modification in various obvious respects without departing from the present disclosure. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not restrictive.

[0019] The invention disclosed herein will be more readily understood by reading the specification with reference to the accompanying drawings, which form a part of the specification.

Brief Description of the Drawings

[0020]

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DETAILED DESCRIPTION OF THE INVENTION

[0021] The devices, systems, and methods described herein may be used for the purpose of draining and moving body fluid from one cavity to another within the human body or for draining or moving. In particular, the devices, systems, and methods described herein include an automatic pump that provides a general pumping function in a body fluid management system using an automatic pump.

[0022] For the sake of explanation, the disclosure herein includes a discussion regarding the use of a body fluid management system using an automatic pump for the purpose of draining pleural effusion for the treatment of pleural effusion. However, it should be understood that such an application is only a specific application of a specific embodiment of a body fluid management system using an automatic pump, and other embodiments and applications are possible.

[0023] Similarly, for purposes of explanation, the disclosure herein describes an automatic pump as part of a body fluid management system using a specific automatic pump. However, any such body fluid management system using an automatic pump disclosed herein is merely a specific embodiment of a body fluid management system using an automatic pump as described herein, and it should be understood that other uses of the automatic pump are possible.

[0024] A body fluid management system using an automatic pump can provide for the periodic, continuous, and automatic drainage of body fluid. Thereby, many of the drawbacks of other techniques for draining body fluid may be avoided.

[0025] 1. Body Fluid Management System Using an Automatic Pump FIG. 1 is a perspective view of a body fluid management system using an automatic pump, including an automatic pump and inlet and outlet tubes (these depictions are shown schematically with reduced length for purposes of illustration). FIG. 1 shows one embodiment of a body fluid management system using an automatic pump for purposes of explanation, and it should be understood that other embodiments are possible.

[0026] a. Body Fluid Management System Using an Automatic Pump in General Referring to FIG. 1, a body fluid management system 100 using an automatic pump for the movement of body fluid from a first body compartment to a second body compartment generally includes an inlet 130 and an outlet 132, and a pump 110 capable of moving body fluid between the inlet 130 and the outlet 132.

[0027] The body fluid management system 100 using an automatic pump also includes a first tube 120 and a second tube 122. The inlet 130 and the outlet 132 communicate between the inside and the outside of the pump 110, respectively, and are connected 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 and the internal space of the pump 110, respectively.

[0028] Furthermore, the first tube 120 includes a tube inlet end 150 and a pump inlet end 140. Generally, when using the body fluid management system 100 with an automatic pump, the tube inlet end 150 is configured to be disposed in a region of the human body from which body fluid is discharged. On the other hand, the pump inlet end 140 is connected to the inlet 130 of the pump 110. Therefore, the length of the first tube 120 may vary as indicated by the length extension 160.

[0029] Similarly, the second tube 122 includes a pump outlet end 142 and a tube outlet end 152. Generally, when using the body fluid management system 100 with an automatic pump, the tube outlet end 152 is configured to be disposed in a region of the human body to which body fluid is discharged. On the other hand, the pump outlet end 142 is connected to the outlet 132 of the pump 110. Therefore, the length of the second tube 122 may vary as indicated by the length extension 162.

[0030] The first tube 120 and the second tube 122 are shown entering the pump 110 substantially linearly (i.e., at a right angle to the wall of the pump 110), but 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 enter and exit the pump 110 at an angle of about 90 degrees, respectively, so that the pump 110 can be more favorably positioned. Also, there may be cases where it is desirable for the first tube 120 and the second tube 122 to enter and exit at other angles.

[0031] Tubes 120 and 122 are shown generally as flexible tubes that can be manipulated and shaped or manipulated and shaped into any form or orientation, although in some embodiments, it may be desirable for tubes 120 and 122 to be set to some degree of rigidity or semi-rigidity so that the desired shape or orientation of the tubes is maintained. For example, at least a portion of one of the tubes may be rigidly or semi-rigidly configured, shaped, or cast so that it has a 90-degree bend as it leaves the intercostal pump 110. Tubes 120 and 122 may each be configured with a similar 90-degree bend. Alternatively, the tubes may not have similar bends. As yet another alternative, the tubes may each have other degrees of bend.

[0032] To effect the movement of body fluid using an automatic pump, pump 110 may be an automatic intercostal pump, which is described in more detail below, and which utilizes the movement of the ribs during normal breathing to automatically and periodically compress and decompress an elastic flexible chamber between adjacent ribs, thereby providing a pumping action, and which is composed of a substantially elastic flexible chamber with a one-way valve at the inlet and a one-way valve at the outlet. Alternatively, pump 110 may be a 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, which is described in more detail below. Other types of pumps are possible.

[0033] b. Body fluid management system using a pleuroperitoneal automatic pump Referring to FIG. 2A, there is shown a body fluid management system 100 using an automatic pump and implanted in a patient 200 for providing drainage of body fluid from a first region 220 to a second region 230 within the patient's body. In one embodiment, as in the embodiment shown in FIG. 2A, the body 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.

[0034] In one embodiment, the automatic pump 110 is configured to be disposed outside the patient's bony rib cage 400 under the patient's skin. To access the patient's pleural cavity 220, the first tube 120 extends from the pump inlet 130, traverses the bony rib cage 400 between adjacent ribs, and the tube inlet end 150 of the first tube 120 is disposed in the pleural cavity 220 from which body fluid is drained. The second tube 122 extends from the pump outlet 132, traverses under the skin along the abdominal wall, and the tube outlet end 152 of the second tube 122 is disposed in the peritoneal cavity 230 into which body fluid is drained. The peritoneal cavity 230 has a body fluid absorption capacity such that excess body fluid transferred from the pleural cavity 220 is absorbed, for example, into the patient's interstitial tissue, lymphatic vessels and blood vessels, thereby minimizing the accumulation of body fluid in the peritoneal cavity 230.

[0035] In other embodiments, as shown in FIG. 2B, the automatic pump 110 can be configured to be disposed within the patient's pleural cavity 220. The tube inlet end 150 of the first tube 120 and the first tube 120 can be disposed in the pleural cavity 220 from which body fluid is drained. The second tube 122 enters the peritoneal cavity from the pump outlet 132 of the automatic pump 110 located within the pleural cavity 120 such that the tube outlet end 152 of the second tube 122 is disposed in the peritoneal cavity 230 into which body fluid is drained. The second tube 122 may traverse the bony rib cage 400 between adjacent ribs, move 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 disposed in the peritoneal cavity 230 into which body fluid is drained. Alternatively, the passage of the second tube 122 may enter directly from the patient's pleural cavity 220 through the diaphragm 240 into the patient's peritoneal cavity 230.

[0036] In other embodiments, as shown in FIG. 2C, the automatic pump 110 and the outlet second tube 230 may be configured such that the first tube passes from the pump inlet 130 through the abdominal wall along the bony rib cage 400 under the skin, traverses the bony rib cage 400 between adjacent ribs, and penetrates into the pleural cavity 220 such that the tube inlet end 150 of the first tube 120 is located within the pleural cavity and is disposed within the peritoneal cavity 230 of the patient. Alternatively, the passage of the first tube 120 may enter directly from the patient's pleural cavity 220 through the diaphragm 240 into the patient's peritoneal cavity 230.

[0037] c. Intrapleural pressure and intraperitoneal pressure The pressures within the pleural cavity 220 and the peritoneal cavity 230 are not the same, are not static, and generally vary during normal breathing. Inhalation is an active process that requires muscle contraction. During inhalation, the external intercostal muscles contract, raising the ribs and sternum, and the diaphragm contracts, flattening and depressing the abdominal contents. This combined action results in the expansion of the thoracic cavity due to a decrease in the intrapleural pressure (P pleural ) and a simultaneous compression of the abdominal contents due to an increase in the intraperitoneal pressure (P peritoneal ). Exhalation during normal breathing is a passive process that mainly depends on elastic recoil forces. During exhalation, the external intercostal muscles and the diaphragm simply relax. The relaxation of the external intercostal muscles allows the elasticity of the inflated lungs to contract the lungs back to their original position. At the same time, the diaphragm relaxes, and the compressed abdominal contents push up the diaphragm. This combined action results in a decrease in the size of the thoracic cavity due to an increase in the intrapleural pressure (P pleural ) and a simultaneous decrease in the intraperitoneal pressure (P peritoneal ).

[0038] As seen in FIG. 3, during normal quiet breathing of a patient with little or no pleural effusion, the intrapleural pressure (P pleural ) varies from approximately +3 cmH2O at the end of exhalation to approximately -2 cmH2O at the end of inhalation, and the intraperitoneal pressure (P peritoneal) varies from approximately +5 cmH2O at the end of expiration to approximately +13 cmH2O at the end of inspiration. The overall intrathoracic pressure is lower than the intraperitoneal pressure during the entire respiratory cycle with a gradient that varies on average from approximately -2 cmH2O at the end of expiration to approximately -15 cmH2O at the end of inspiration. [Miller JD, Skeletal muscle pump versus respiratory muscle pump: modulation of venous return from the locomotor limb in humans, J Physiol, Vol. 563, No. 3, pp. 925-943 (2005)]. The intrathoracic pressure, the intraperitoneal pressure, and the pressure gradient between the intrathoracic and intraperitoneal pressures vary among patients and are altered by exertion, cough, sneeze, deep breathing, body position, thoracic or abdominal disease, past thoracic or abdominal surgery, and the presence of pleural effusion. In fact, the presence of pleural effusion adds a significant hydrostatic pressure component to the intrathoracic pressure, and the intrathoracic pressure may change from a low or negative value to a positive value. In fact, in patients with pleural effusion, the intrathoracic pressure (P pleural ) may increase to approximately +10 to approximately +15 cmH2O when an exudate is present and may decrease to approximately -10 to approximately -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 variations that occur during normal breathing, the intrathoracic pressure may become higher than the intraperitoneal pressure during the respiratory cycle with a gradient ranging from approximately -5 cmH2O to approximately +13 cmH2O when an exudate is present.

[0039] For the fluid management system 100 using an automatic pump for transferring body fluid from the pleural cavity 220 to the peritoneal cavity 230, the automatic pump 110 can overcome the pressure gradient existing between the pleural cavity 220 and the peritoneal cavity 230. As outlined above, this pressure gradient changes during the respiratory cycle, and in the case of pleural effusion, the amount of the existing exudate also changes. When the fluid management system 100 using an automatic pump is first placed and there is exudate in the pleural cavity 220, the body fluid can flow freely between the pleural cavity 220 and the peritoneal cavity 230 when the valve in the automatic pump 110 has a composite opening pressure lower than the pressure gradient between the intrapleural and intraperitoneal pressures.

[0040] When the pleural effusion is almost drained from the pleural cavity 220, as shown in FIG. 3, the pressure gradient between the intrapleural and intraperitoneal spaces becomes lower. Due to this pressure gradient, at the end of exhalation, the automatic pump 110 can generate at least about 2 cmH2O of head pressure to overcome this pressure gradient and pump body fluid from the pleural cavity 220 to the peritoneal cavity 230. Similarly, at the end of inspiration, the automatic pump 110 can generate at least about 15 cmH2O of head pressure to overcome the pressure gradient between the peritoneal cavity 230 and the pleural cavity 220, thereby pumping body fluid from the pleural cavity 220 to the peritoneal cavity 230. It should be noted that when the pump generates a constant head pressure, the flow between the pleural cavity 220 and the peritoneal cavity 230 changes during the respiratory cycle because the pressure gradient between the peritoneal cavity 230 and the pleural cavity 220 changes. The above values are based on average observations. In some cases, the pump may generate at least about 25 cmH2O of head pressure to overcome the fluctuations in the pressure gradient present throughout the normal respiratory cycle, thereby being able to pump body fluid from the pleural cavity 220 and the peritoneal cavity 230 at any time. Furthermore, to overcome the variations between patients, it may generate a head pressure ranging from 35 cmH2O to 50 cmH2O. Additionally, it can be noted that the automatic pump 110 can be designed to operate preferentially during exhalation, and ideally, it can be designed to operate at the end of exhalation where the pressure gradient between the peritoneal cavity 230 and the pleural cavity 220 is lower. In this situation, to overcome the variations between patients and pump body fluid from the pleural cavity 220 to the peritoneal cavity 230, the automatic pump 110 only needs to generate a minimum head pressure of about 5 cmH2O, or preferably a head pressure of about 10 cmH2O to 15 cmH2O. This lower head pressure leads to a lower rate of power consumption for the automatic pump 110 and a lower total working time per unit volume of the exudate pumped compared to the operation of the automatic pump 110 at the start of exhalation or the end of inspiration throughout the entire respiratory cycle.

[0041] d. Pleural fluid debris and coagulated proteins Pleural fluid is essentially a filtrate of blood that has been modified by reabsorption, whether in a healthy or diseased state. Filtration occurs through the vascular walls, interstitial tissues, and mesothelial cell membranes on the surfaces of both the visceral and parietal pleurae, and the modification occurs through the reabsorption of body fluids, solutes, proteins, and cells. Similar to the interstitial fluid of other organs, in healthy individuals, pleural fluid contains proteins and a small number of cells. The proteins in pleural fluid have a total concentration of approximately 1.0 g / dl (plasma total protein concentration of 6.0 g / dl or more), with albumin being the most abundant, accounting for approximately 50% of the total protein, globulin being the second most abundant, accounting for approximately 35% of the total protein, fibrinogen being the third most abundant, accounting for less than 20% of the protein. The cell concentration is approximately 2,000 cells / mm 3 which is the pleural fluid volume and consists mainly of mesothelial cells, monocytes, and lymphocytes.

[0042] In malignant tumors, the balance of this filtration and reabsorption system is disrupted. The cells, membranes, and tissues that help filter the blood tend to be less selective, the reabsorption mechanism has changed, and is usually less efficient. Therefore, the pleural fluid produced in malignant tumors has an increased volume, abnormal composition, with the body fluid being rich in both proteins and cells, and different types of proteins and cells present. In fact, the total protein concentration of pleural fluid usually exceeds 2.9 g / dl, and the cell concentration can be several times higher.

[0043] Fibrinogen is an important protein in pleural fluid. Fibrinogen is converted to fibrin by thrombin in a process called fibrin formation. Fibrin is broken down by the action of plasminogen in a process called fibrinolysis. On the other hand, plasminogen is activated by tissue plasminogen activator (tPA), and tPA is inhibited by plasminogen activator inhibitor-1 (PAI-1). The net amount of fibrin produced is the result of an imbalance between fibrin formation and fibrinolysis.

[0044] The fibrinogen concentration in pleural fluid is usually lower than that in plasma. Even in patients with malignant tumors, when the total protein concentration shows an increasing trend, the fibrinogen concentration in pleural fluid tends to be lower, the pleural fluid level of tPA tends to increase, and PAI-1 tends to decrease. All of these tend to reduce the net production of fibrin.

[0045] Nevertheless, in patients with malignant pleural effusion, an imbalance between fibrinolysis and fibrin formation can occur, still having the potential to result in fibrin formation. Fibrin can organize into small clots, strands, membranes, and septa. Fibrin membranes and septa are responsible for locules or pockets of pleural fluid that can make it difficult to drain body fluids from the pleural cavity, and fibrin clots and strands can block the drainage tube.

[0046] Indeed, the gross anatomical findings in malignant pleural effusion revealed by transthoracic ultrasound of the pleural cavity showed complex septated effusions in 8.7% of patients, homogeneous echogenic effusions in 15.4% of patients, and complex non-septated effusions in 65.4% of patients, both of which are likely to be some combination of blood and cells and fibrinous debris, and anechoic (clear body fluid) was only 10.6% of patients.

[0047] To prevent blockages or clogs in a body fluid management system using an automatic pump and maintain flow through the system, multiple strategies may be used alone or in combination. One strategy is to provide multiple body fluid inlet passages. Referring to FIG. 4, the first tube 120 may include one or more body fluid inlet perforations 170. The body fluid inlet perforations 170 may take the form of holes in the wall of the first tube 120 to allow body fluid to be drawn into the first tube 120 not only through the tube inlet end 150 but also through the body fluid inlet perforations 170. The body fluid inlet perforations 170 may prevent obstruction of flow into the first tube 120, may improve the volume or efficiency of body fluid suction into the first tube 120, and thereby may improve the volume or efficiency of body fluid discharged by the body fluid management system 101 using an automatic pump. The body fluid inlet perforations 170 may also be beneficial by allowing alternative body fluid inlet locations 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 by the juxtaposition of the first tube 120 against the chest wall or lung. The second tube 122 may also include a body fluid outlet perforation 180.

[0048] An additional or alternative strategy is to construct a first tube 120 for providing a filtration mechanism for body fluid entering a body fluid management system using an automatic pump. Referring to FIG. 5, the first tube 120 may include one or more body fluid filtration inlet perforations 173. The body fluid filtration inlet perforations 173 may be in the form of holes in the wall of the first tube 120 to allow body fluid to be drawn into the first tube 120. The body fluid filtration inlet perforations 173 are sized and shaped such that any fibrin clots, fibrin strands or other debris that can pass through the filtration perforations 173 can pass through the entire body fluid passage of the filtered body fluid management system 102 using an automatic pump without blocking or significantly impeding the flow of body fluid. Alternatively, the body fluid filtration inlet perforations 173 are sized and shaped such that any such perforations are smaller than the smallest opening that exists along the entire body fluid passage of the filtered body fluid management system 102 using an automatic pump. Thus, any fibrin clots, fibrin strands or other debris that can pass through the body fluid filtration inlet perforations 173 are smaller than the smallest opening of the body fluid passage of the filtered body fluid management system 102 using an automatic pump and should therefore be able to pass through the body fluid passage of the filtered body fluid management system 102 using an automatic pump. 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 assist in the placement of the first tube 120.

[0049] In another additional or alternative potential strategy, as shown in FIG. 6, a fibrinolytic coating 190 is provided on at least a portion of the first tube 120 that is exposed to the pleural fluid. Such a fibrinolytic coating 190 can serve to break down fibrin, fibrin clots, fibrin strands, fibrin membranes, fibrinous septa and any other fibrinous debris in the body fluid, and enable the filtered body fluid management system 102 using an automatic pump to allow the body fluid to pass through. Examples of fibrinolytic factors of the fibrinolytic coating 190 include plasmin, tissue plasminogen activator, urokinase, streptokinase, plasminogen activator inhibitor 1 inhibitor and plasminogen activator inhibitor 2 inhibitor. Other examples of fibrinolytic agents may be used.

[0050] In another additional or alternative strategy, as shown in FIG. 7, a fibrin scavenger 192 is provided on at least a portion of the first tube 120 that is exposed to the pleural fluid. The fibrin scavenger is designed to convert fibrinogen to fibrin and attach to the tip of the catheter so that it cannot freely enter the body fluid passage of the body fluid management system 102 using an automatic pump in the pleural fluid. Examples of fibrin scavengers include thrombin, factor XIIIa, surface roughness, surface properties, microfibers 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 body fluid passage of the body fluid management system 102 using an automatic pump in the pleural fluid.

[0051] For additional or alternative strategies to prevent clogging, the fluid inlet, fluid outlet, first tube, second tube, or any other aspect of the fluid management system using an automatic pump may be coated with an anticoagulant factor or a fibrinolytic factor. For example, components or surfaces of the pump 110, first tube 120, or second tube 122 may be coated with an anticoagulant factor or a fibrinolytic factor at least in part. The presence of an anticoagulant factor may reduce the amount of clotting (which would otherwise occur in the absence of the anticoagulant factor). Examples of anticoagulant factors include heparin, low molecular weight heparin, fondaparinux, idraparinux, idrabiotaparinux, dabigatran, rivaroxaban, apixaban, betrixaban, edoxaban, darexaban, letaxaban, eribaxaban, hirudin, lepirudin, bivalirudin, argatroban, dabigatran, ximelagatran, hementin, vitamin E, coumarin, warfarin, acenocoumarol, phenprocoumon, atromentin, phenindione, brodifacoum, and difenacoum. Examples of fibrinolytic factors include plasmin, tissue plasminogen activator, urokinase, streptokinase, plasminogen activator inhibitor 1 inhibitor, and plasminogen activator inhibitor 2 inhibitor. Other examples of anticoagulant factors or fibrinolytic agents may be used.

[0052] In another additional or alternative potential strategy, to prevent clogging or to address clogging if it occurs, the wall of the automatic pump 110 may be constructed of a material that can be pierced with a needle or similar object to allow for the injection of, for example, an anticoagulant, fibrinolytic agent, or other suitable material into the interior of the fluid management system 100 using the automatic pump. Alternatively, and as further described below, an access port may be added to the automatic pump 110 that allows for the injection of, for example, an anticoagulant, fibrinolytic agent, or other suitable material into the interior of the fluid management system 100 using the automatic pump.

[0053] As an additional or alternative strategy to prevent clogging, patients may be selected based on favorable pleural fluid characteristics that are revealed by a transthoracic ultrasound of the pleural cavity 220 and that are less likely to clog the system. For example, the use of a fluid management system with an automatic pump may be limited to patients presenting anechoic (clear body fluid) as revealed by a transthoracic ultrasound of the pleural cavity 220. Other pleural fluid characteristics such as complex septated effusions, homogeneous echogenic effusions, and complex non-septated effusions, or combinations of characteristics, may also be preferred.

[0054] 2. Fluid management system using an automatic intercostal pump Referring to FIG. 8A, a fluid management system 103 using an automatic intercostal pump for placement between the first and second ribs generally includes a pump 111 that is an elastic and flexible structure surrounding an internal 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 an elastic and 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 constituent materials provides elasticity and at least one of the constituent materials provides containment of body fluid. For example, the pump 111 may be composed of an elastic nitinol, steel, polyester, or other elastic component for providing elasticity, and a second body fluid containment component such as polyurethane, silicone, polyvinyl chloride, latex rubber, polyethylene terephthalate, nylon, polytetrafluoroethylene, PEBAX (registered trademark: No. 1703062) for providing containment of body fluid within the pump 111.

[0055] The pump 111 is shown as being generally cylindrical, but other configurations are possible. In short, the pump 111 may be of any shape to provide appropriate compression / decompression and placement in the intercostal region. In particular, it may be desirable to adapt the pump 111 to the characteristics of a particular region (i.e., both or one of shape and cavity). In one embodiment, the pump 111 may include a flexible silicone tube. However, the pump 111 may take other forms.

[0056] The body fluid management system 103 using an automatic intercostal pump also includes a first tube 120 and a second tube 122. The inlet 130 and the outlet 132 communicate between the inside and the outside of the intercostal pump 111 respectively, and are connected 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 internal space of the intercostal pump 111.

[0057] The first tube 120 includes a tube inlet end 150 and a pump inlet end 140. Generally, when the body fluid management system 103 using an automatic intercostal pump is used, the tube inlet end 150 is configured to be disposed in a region of the human body from which body fluid is discharged. On the other hand, the pump inlet end 140 is connected to the inlet 130 of the intercostal pump 111. Therefore, the length of the first tube 120 may vary as shown by the length extension 160.

[0058] Similarly, the second tube 122 includes a pump outlet end 142 and a tube outlet end 152. Generally, when the body fluid management system 103 using an automatic intercostal pump is used, the tube outlet end 152 is configured to be disposed in a region of the human body to which body fluid is discharged. On the other hand, the pump outlet end 142 is connected to the outlet 132 of the intercostal pump 111. Therefore, the length of the second tube 122 may vary as shown by the length extension 162.

[0059] The first tube 120 and the second tube 122 are shown as entering the intercostal pump 111 substantially linearly (i.e., at a right angle to the wall of the pump 111), but 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 enter and exit the intercostal pump 111 at an angle of approximately 90 degrees so that the intercostal pump 111 can be more advantageously positioned within the intercostal region. There may also be cases where it is desirable for the first tube 120 and the second tube 122 to enter and exit at other angles.

[0060] Tubes 120 and 122 are shown generally as flexible tubes that can be easily manipulated and shaped or manipulated and shaped into any form or orientation, but in some embodiments, it may be desirable for tubes 120 and 122 to be set to be somewhat rigid or semi-rigid so that the desired shape or orientation of the tubes is maintained. For example, at least a portion of one of the tubes may be configured, shaped, or cast to be rigid or semi-rigid so that it has a 90-degree bend when leaving the 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.

[0061] Referring to FIG. 8A, the first tube 120 may include one or more body fluid inlet perforations 170. The body fluid inlet perforations 170 may take the form of holes in the surface of the first tube 120, not only at the tube inlet end 150, but also to allow body fluid to be drawn into the first tube 120 through the body fluid inlet perforations 170. The body fluid inlet perforations 170 may improve the volume or efficiency of body fluid suction into the first tube 120, and thereby may improve the volume or efficiency of body fluid discharged by the body fluid management system 103 using the intercostal pump. The body fluid inlet perforations 170 may be particularly beneficial as they allow for an alternative body fluid inlet location, especially when the tube inlet end 150 or other perforations are blocked, for example, by fibrin clots, fibrin strands or other debris, or by the juxtaposition of the first tube 120 against the chest wall or lung. The second tube 122 may also include a body fluid outlet perforation 180.

[0062] Referring to FIG. 8B and the insertion cross-sectional view C shown therein, the first tube 120 may include one or more straight body fluid channels 175. The liner body fluid inlet slit 174 on the surface of the first tube 120 opens into the straight body fluid channel 175, enabling the suction of body fluid into the straight body fluid channel 175 of the first tube 120. By combining these mechanisms, they provide redundancy against clogging of the first tube 120. The straight body fluid inlet slit 174 is such that when a single slit or part of a plurality of slits is blocked, for example, by fibrin clots, fibrin strands or other debris, or by the juxtaposition of the first tube 120 against the chest wall or lung, the entire first tube 120 is still able to pass body fluid through its interior and along its longitudinal direction. This is particularly advantageous by allowing substantially continuous access to the interior of the first tube 120 along a substantial portion of its length. Further, the straight body fluid suction slit 174 can be sized to limit the size of particles or debris entering the straight body fluid channel 175. This size can be selected to prevent the entry of particles or debris large enough to clog the lumen of the straight body fluid channel 175 or any other constriction within the body fluid management system 103 using the automatic intercostal pump.

[0063] The body fluid management system 103 using the automatic intercostal pump described with respect to FIGS. 8A and 8B may additionally or alternatively include any other mechanisms, materials or characteristics described with respect to the body fluid management systems using the automatic pumps of FIGS. 4 - 7.

[0064] 3. Body Fluid Management System Using a Pleuroperitoneal Intercostal Pump Referring to FIG. 9, a body fluid management system 103 using an automatic intercostal pump is shown for providing drainage of body fluid from a first region 220 to a second region 230 within a patient's body. In one embodiment, as in the embodiment shown in FIG. 9, the body 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.

[0065] In one embodiment, the automatic intercostal pump 111 is configured to be disposed at least partially in the intercostal region between two ribs. In other words, when implanted, the intercostal pump 111 extends through the intercostal space of the patient, or a portion thereof. Accordingly, the first tube 120 and the corresponding pump inlet 130 are disposed inside the bony thorax of the patient. The second tube 122 and the corresponding pump outlet 132 are disposed outside the bony thorax of the patient. Thus, due to respiration and the corresponding compression / decompression of the bony thorax, the patient 210 will automatically operate (e.g., "pump") the intercostal pump 111. The operation of the intercostal pump 111 will be further described below.

[0066] 4. Automatic Intercostal Pump a. Design of the Automatic Intercostal Pump FIG. 10A shows a schematic cross-sectional view of the automatic intercostal pump 111 in a substantially or substantially non-compressed state with both the inlet check valve 320 and the outlet check valve 322 (described in more detail below) closed. As described above, the automatic intercostal pump 111 may be a flexible tube or cylinder made of polyurethane, silicone, polyvinyl chloride, latex rubber or other suitable elastic material. Alternatively, the pump 111 may be made of a combination of two or more materials, at least one of which provides elasticity and at least one of which provides containment of body fluid. For example, the pump 111 may include a first elastic component such as elastic nitinol, steel, polyester or other elastic component, and a second body fluid containment component such as polyurethane, silicone, polyvinyl chloride, latex rubber, polyethylene terephthalate, nylon, polytetrafluoroethylene, PEBAX (Registered Trademark: No. 1703062) to minimize leakage from the intercostal pump 111.

[0067] The intercostal pump 111 includes a pump wall surrounding an internal space 330. For the sake of explanation, the pump wall is shown as including an upper wall 310 and a lower wall 312. The distinction between the upper wall and the lower wall is made for the purpose of clarity in explaining the compression / decompression of the intercostal pump 111 and should not be construed as limiting the intercostal pump 111 to include two different pump walls.

[0068] Roughly, the pump wall 310 (312) may be composed of any material and any thickness suitable for achieving the desired flexibility and elasticity of the intercostal pump 111. The specific thickness of the pump wall 310 (312) in a given embodiment may depend, for example, on the material of the pump wall 310 (312) and the purpose of 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 of about 1.15 to about 5.5 MPa), preferably about 40 to about 60 (Young's modulus of about 1.7 to about 3.6 MPa), more preferably about 45 to about 50 (Young's modulus of 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, and the corresponding wall thickness may be 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 also be desired.

[0069] The intercostal pump 111 further includes an inlet check valve 320 and an outlet check valve 322. The inlet valve 320 may be located within the internal space 330 of the pump body in close proximity to the inlet 130. The inlet check valve 320 may be any suitable check valve, for example, made of silicone or other suitable material. The inlet check valve 320 is configured to prevent or substantially prevent the movement of body fluid from the internal space 330 of the intercostal pump 111 to the inlet 130. At the same time, the inlet check valve 320 is configured to allow the movement of body fluid from the inlet 130 to the internal space 330 of the intercostal pump 111. In other words, the inlet check valve 320 is in fluid communication with the inlet 130 so as to provide, generally, a one-way movement of body fluid from the inlet 130 to the internal space 330 of the intercostal pump 110.

[0070] Accordingly, the outlet check valve 322 may be located within the internal space 330 of the pump body in close proximity to the outlet 132. The outlet check valve 322 may be any suitable check valve, for example, made of silicone or other suitable material. The outlet check valve 322 is configured to allow the movement of body fluid from the internal space 330 of the intercostal pump 111 to the outlet 132. At the same time, the outlet check valve 322 is configured to prevent or substantially prevent the movement of body fluid from the outlet 132 to the internal space 330 of the intercostal pump 111. In other words, the outlet check valve 322 is in fluid communication with the outlet 132 so as to provide a one-way movement of body fluid from the internal space 330 of the intercostal pump 111 to the outlet 132.

[0071] In one embodiment of the intercostal pump 111, inlet check valve frame 340 and outlet check valve frame 342 are respectively added to the outer periphery of inlet check valve 320 and outlet check valve 322 so that the compression / decompression of the intercostal pump 111 does not cause significant compression, deformation or undesirable wear to inlet check valve 320 and outlet check valve 322. Inlet check valve frame 340 and outlet check valve frame 342 may each be constructed of any relatively rigid or non-flexible material for the outer periphery of inlet check valve 320 and outlet check valve 322 respectively. Further, the respective sizes and shapes of inlet check valve frame 340 and outlet check valve frame 342 can be selected to provide a joint or interconnectable joint between first tube 120 and second tube 122 and the upper wall 310 and lower wall 312 of the intercostal pump 111. Other types of valve frames can be used that can function so that the compression / decompression of the intercostal pump 111 does not cause significant compression, deformation, or undesirable wear to inlet check valve 320 and outlet check valve 322.

[0072] Although inlet check valve 320 and outlet check valve 322 are shown to be located within the internal space 330 of the intercostal pump 111, it should be noted that alternative arrangements of the valves may be desirable in some cases. For example, one or both of inlet check valve 320 and outlet check valve 322 may be located outside the pump body respectively, or possibly within inlet tube 120 and outlet tube 122, or respectively between inlet tube 120 and the pump body, or between outlet tube 122 and the pump body. The particular arrangement of the valves is not necessarily critical as long as it substantially provides sufficient one-way flow of body fluid in and out of the intercostal pump 111.

[0073] b. Pump operation Figure 10B shows a schematic cross-sectional view of the intercostal pump 111 in a substantially or approximately compressed state. In one embodiment, as shown, a first force 350 may be applied to the upper wall 310 to cause the upper wall 310 to be recessed toward the internal space 330. Correspondingly, a second force 352 may be additionally or alternatively applied to the lower wall 312 to cause the lower wall 312 to be recessed toward the internal space 330. The recesses of the upper wall 310 and the lower wall 312 or the upper wall 310 or the lower wall 312 help to reduce the volume of the internal space 330 and increase the pressure in the internal space 330. Due to this increase in pressure, the inlet one-way valve 320 remains closed, the outlet one-way valve 322 opens, and the body fluid located within the internal space 330 flows from the internal space 330, through the outlet one-way valve 322, and into the second tube 122. In the case of non-compressible body fluid, the change in volume received by the internal space in response to the recesses of the upper wall 310 and the lower wall 312 or the upper wall 310 or the lower wall 312 is approximately equal to the volume of the body fluid that moves from the internal space 330 through the outlet one-way valve 322. When the body fluid moves from the internal space 330 through the outlet one-way valve 322, the pressure in the internal space decreases. When the internal pressure is approximately equal to or substantially equal to the pressure at the pump outlet 132, the flow stops and, as shown in Figure 10C, the outlet one-way valve 322 closes.

[0074] As described above, the intercostal pump 111 is substantially elastically flexible, and thus, as shown in Figures 10B and 10C, after being placed in a compressed state, when at least one of the first force 350 and the second force 352 is removed, the intercostal pump 111 returns to an uncompressed state as shown in Figure 10D. As the upper wall 310 returns to the uncompressed state as the first force 350 is removed, and as the lower wall 312 returns to the uncompressed state as the second force 352 is removed, or for either of these reasons, the volume of the internal space 330 increases and the pressure in the internal space 330 decreases. The pressure inside the internal space 330 finally falls below the pressure inside the inlet, opening the inlet one-way valve 320 and allowing the body fluid located at the inlet to flow into the internal space 330. In this way, the intercostal pump 111 generally operates as a pump that draws in body fluid from the inlet 130 and delivers the body fluid to the outlet 132.

[0075] Furthermore, as shown in FIGS. 10E and 10F, the intercostal pump 111 may be configured with a reinforcement member 333 integrated with or attached to the wall such that, when at least one of the first force 350 and the second force 352 is applied, a greater change in volume occurs in the internal space 330 as compared to the change in volume of the internal space 330 when there is no reinforcement member 333, as shown in FIGS. 10A and 10B. The reason for this is that the reinforcement member 333 helps distribute the first force 350 and the second force 352, which are applied relatively narrowly along the longer lengths of the upper wall 310 and the lower wall 312 of the pump, thereby causing a greater change in the internal volume 330 of the pump. The reinforcement member 333 is shown positioned intermediate along the longitudinal direction of the upper wall 310 and the lower wall 312 such that both ends of the reinforcement member 333 move together, but the reinforcement member could instead be positioned such that one end of each member is located near or even attached to the inlet check valve frame 340 or the outlet check valve frame 342 so as to function as a lever arm that provides a greater change in volume to the internal space 330 when at least one of the first force 350 and the second force 352 is applied. The reinforcement member 333 can generally be of any suitable size and shape and can be made of any suitable material, and in some cases, can be made of any suitable material that is generally more rigid than the material forming the upper wall 310 and the lower wall 312.

[0076] The intercostal pump 111 may be compressed during use as a result of a patient's breathing. More specifically, the intercostal pump 111 may be compressed as a result of the natural movement of a patient's ribs during the breathing cycle. Further, the intercostal pump 111 may be positioned such that the internal space 330 passes between the fibers of the external intercostal muscles or the internal intercostal muscles and may be compressed as a result of the contraction of these muscle fibers.

[0077] As shown in FIG. 11A, during use, the intercostal pump 111 is disposed 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 anatomically first and second ribs, although they may in some cases. 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.

[0078] As shown in FIG. 11B, when the bony thorax contracts (during expiration), the individual ribs 410, 412, 414, and 416 move towards 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 applied to 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 in a generally or substantially compressed state.

[0079] The average adult breathes approximately 16 times per minute. Thus, during use, the intercostal pump 111 may be compressed approximately 16 times per minute, or approximately 23,040 times per day. Of course, this is merely an estimate and can vary widely. The specific compression rate is not necessarily critical to the function of the intercostal pump 111, but the rate at which body fluid is pumped varies with the compression rate and the magnitude of the compression (i.e., the degree of rib movement).

[0080] The average adult exhibits a relative movement of approximately 0.25 to 3 millimeters between the first rib 412 and the second rib 414 through the respiratory cycle. Thus, the walls of the intercostal pump 111 may be compressed approximately 0.25 to 3 millimeters during each breath. This is of course also merely an estimate and can vary widely from patient to patient and may vary for a particular patient depending on the specific anatomical first and second ribs 412 and 414 and their specific longitudinal position relative to both or either the spine and the sternum.

[0081] A related consideration is that the ribs are covered by soft tissue. The soft tissue itself is compressible, and thus, if soft tissue remains between the intercostal pump 111 and either the first rib 412 or the second rib 414, the entire compressible range of the intercostal pump 111 may be affected. Thus, in some cases, it may be desirable to remove the soft tissue at the portion where the intercostal pump 111 contacts either the first rib 412 or the second rib 414.

[0082] Another related consideration is that the ribs may generally exhibit a relatively cartilaginous portion that is itself relatively compressible. As a result, in some cases, it may be desirable to position the intercostal pump 111 to contact portions of the first rib 412 and the second rib 414 that exhibit relatively little cartilage (i.e., portions where there is a relatively large amount of exposed bone as opposed to cartilage).

[0083] Yet another related consideration is that it may be desirable to position the intercostal pump 111 so as 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 way, the intercostal pump 111 may be subject to greater compression. Thus, as opposed to the substantially vertical orientation roughly shown in FIGS. 11A and 11B, 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 vertical and substantially parallel.

[0084] Yet another related consideration is that, even when the first rib 412 and the second rib 414 are relatively separated, it may be desirable to size the intercostal pump 111 such that at least a portion of the intercostal pump 111 is compressed with respect to the distance between the first rib 412 and the second rib 414 at the end of inspiration. In this way, the change in the distance between the first rib 412 and the second rib 414 that occurs during breathing may be converted into a larger volume change within the intercostal pump 111.

[0085] Yet another related consideration is that, due to the relative movement of the first rib 412, the second rib 414, other tissues of the chest wall and / or the lungs, the intercostal pump 111 changes periodically during breathing, whereby the volume of the internal space 330 of the intercostal pump 111 changes periodically by breathing so that body fluid is pumped, it may be desirable to arrange the intercostal pump 111 with respect to the first rib 412 and the second rib 414.

[0086] c. Valve structure FIG. 12 shows cross-sectional views of a one-way inlet valve in a closed state and an open state, and cross-sectional views of a one-way outlet valve in a closed state and an open state. In panel A, an inlet one-way valve frame 340 surrounds the inlet one-way valve 320 and shows the inlet one-way valve 320 in a closed state that provides structure and support. In panel B, the inlet one-way valve 320 in an open state is shown. The size and shape of the inlet one-way valve frame 340 can be selected to provide a joint or an interconnectable joint to the first tube 120. In panel C, an outlet one-way valve frame 342 surrounds the outlet one-way valve 322 and shows the outlet one-way valve 322 in a closed state that provides structure and support. In panel D, the outlet one-way valve 322 in an open state is shown. The size and shape of the inlet one-way valve frame 342 can be selected to provide a joint or an interconnectable joint to the first tube 122.

[0087] 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 such that the pressure P1 ≦ P2 + P c(where P1 and P2 are the pressures at the positions shown by panel A, and P c is the cracking pressure of the valve). Similarly, when the inlet check valve 320 is in the open position as shown in panel B of FIG. 12, the pressure difference across the valve is the pressure P c > P1 + P2 (where P1 and P2 are the pressures at the positions shown by panel B, and P c is similarly the cracking pressure of the valve).

[0088] For the outlet check valve 322, when it is 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 positions shown by panel C, and P c is the cracking pressure of the valve). Similarly, when the outlet check valve 322 is in the open position shown in panel D of FIG. 12, the pressure difference across the valve is P2 > P3 + P c (where P1 and P2 are the pressures at the positions shown by panel D, and P c is similarly the cracking pressure of the valve).

[0089] In one embodiment, the inlet check valve 320 and the outlet check valve 322 are formed as duckbill valves having thin and substantially flat lips that define slits that can move from the closed position to the open position. In one embodiment, the inlet check valve 320 and the outlet check valve 322 may have a low cracking pressure P c such that the valve transitions from the closed state to the open state with a relatively small pressure difference across the valve. This cracking pressure P cIt can also be reduced to less than about 25 cmH2O, preferably less than about 15 cmH2O, more preferably less than about 10 cmH2O, and even more preferably less than about 5 cmH2O for operation in most patients. In one embodiment, the inlet check valve 320 and the outlet check valve 322 may have a low reseal pressure such that the valve transitions from the open state to the closed state with a small pressure difference across the valve. This reseal pressure can also be reduced to less than about 15 cmH2O, preferably less than about 10 cmH2O, more preferably less than about 5 cmH2O, and even more preferably less than about 2 cmH2O for operation in most patients.

[0090] Furthermore, in one embodiment, the inlet check valve 320 and the outlet check valve 322 are configured to undergo minimal deformation when closed and there is a pressure gradient across the valve in the opposite direction of their one-way flow. Specifically, the inlet check valve undergoes minimal deformation when there is backpressure across the valve, i.e., when P1 ≦ P2 + P c and the outlet check valve undergoes minimal deformation when there is backpressure across the valve, i.e., when P2 ≦ P3 + P c . With such a design, the volume change occurring in the internal space 330 of the pump body is converted almost or substantially one-to-one to the forward flow through the intercostal pump 111. This resistance to deformation can be evaluated as the reverse flow volume that occurs when backpressure is applied across the seal or the closed inlet check valve 320 and outlet check valve 322. When a backpressure of 50 cmH2O or less is applied, the reverse flow may be less than about 200 microliters, preferably less than about 100 microliters, more preferably less than about 50 microliters, and even more preferably less than about 25 microliters for operation in most patients. Thus, the volume (V forward ) pumped in the forward direction in each cycle is close to, substantially equal to, or equal to the volume change (ΔV internal space ) of the internal space 330 of the pump minus the volume of valve deformation required to reseal the valve (V reseal volume ). Generally speaking, in other words, it is as follows.

[0091] Vforward =ΔV internal space -V reseal volume Non-limiting examples of valves that may be used for the one-way valves 320, 322 are of the type described in U.S. Patent No. 5,261,459, entitled "Miniature Duckbill Valve Having a Low Cracking Pressure and High Flow Rate," which is hereby incorporated by reference in its entirety.

[0092] d. Alternative Designs of the Pleuroperitoneal Automatic Intercostal Pump Any aspect, mechanism, characteristic, etc. of the body fluid management system using the automatic pump described in FIGS. 1-7, or combinations thereof, may be incorporated into the body fluid management system using the automatic intercostal pump of FIGS. 8-12. By way of example, to prevent blockage or clogging of the body fluid management system using the automatic intercostal pump and maintain flow through the system, the first tube 120 can be configured to provide a filtering mechanism for the body fluid entering the body fluid management system 104 using the automatic intercostal pump. Referring to FIG. 13, the first tube 120 may include one or more body fluid filtration inlet perforations 173. The body fluid filtration inlet perforations 173 may be in the form of holes in the wall of the first tube 120 to allow the first tube 120 to suck in body fluid. The body fluid filtration inlet perforations 173 are sized and shaped such that any fibrin clots, fibrin strands or other debris that can pass through the filtration perforations 173 can also pass through the entire body fluid passage of the filtered body fluid management system 104 using the intercostal pump without blocking or significantly impeding the flow of body fluid. Alternatively, the body fluid filtration inlet perforations 173 are sized and shaped such that any such perforations are smaller than the smallest openings present along the entire body fluid passage of the filtered body fluid management system 104 using the intercostal pump. For example, the body 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 fibrin clots, fibrin strands or other debris that can pass through the body fluid filtration inlet perforations 173 are smaller than the smallest openings of the body fluid passage of the filtered body fluid management system 104 using the automatic pump, and therefore should be able to pass through the body fluid passage of the filtered body fluid management system 102 using the automatic pump. As shown in FIG. 13, the tube inlet end of the first tube 120 may include a closed end and, in some cases, may be rounded or smoothed to assist in the placement of the first tube 120.

[0093] 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, in some cases, around the intercostal pump, for example, proximate to the outlet portion of the intercostal pump 111. The stability and orientation mechanism 200 is shown in FIG. 14A as a generally rounded, substantially conical mechanism having an annular or partially annular, relatively flat surface 201 with respect to the intercostal pump 111 body and oriented at a suitable angle 203 with respect to the long axis of the intercostal pump 111. In use, as shown in FIG. 14B, when the intercostal pump 111 is disposed between the first rib 414 and the second rib 416, the flat surface 201 of the stability and orientation mechanism 200 interacts with the first rib 414, the second rib 416, and any soft tissue therebetween to orient the intercostal pump 111 at a desired angle, generally determined by the angle 203, with respect to the chest wall and to provide stability at this angle and stability against movement of the intercostal pump along the axis of the intercostal pump with respect to the chest wall. Although shown as generally rounded and conical, the overall shape of the stability and orientation mechanism 200 can be any shape that is essentially useful for orienting the intercostal pump 111 with respect to the chest wall and / or for providing both or either of the stability of its orientation with respect to the chest wall and the axial position stability of the intercostal pump 111.

[0094] Additional embodiments can be constructed to better conform to 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 using an attached intercostal pump includes an attached pump 112 that is approximately or substantially "L-shaped" to better conform to the transition from the pleural cavity to the subcutaneous tissue. More generally, the attached pump 112 may be shaped with a ramp or transition (e.g., between portions 112' and 112'' as described below) that provides a ramped 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 90 degrees. When placed on a patient, the intercostal portion 112' of the attached pump 112 is placed in the intercostal space between the first and second ribs, and the subcutaneous portion 112'' of the pump 112 is placed in the subcutaneous tissue under the skin and outside the bony rib cage. In this configuration and placement, with the patient's breathing, the intercostal portion 112' of the pump 112 is periodically compressed and decompressed by the first and second ribs, as described, for example, 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 cavity to the peritoneal cavity. Further, in this configuration and placement, the subcutaneous portion 112'' of the pump 112 is placed outside the bony rib cage and can provide additional pumping action of the pump 112 as needed to supplement the flow of fluid from the pleural cavity to the peritoneal cavity, utilizing periodic (or aperiodic) manual compression between the skin and the rib cage. FIG. 15B is a schematic cross-sectional view of the pump 112 of the fluid management system 105 using an attached intercostal pump.

[0095] Another alternative means for providing a better fit and stable positioning by transition between the pleural cavity and the subcutaneous tissue of the chest wall is shown in FIG. 16A. The transfer fluid management system 106 using an intercostal pump includes an intercostal pump 113 connected to a transfer chamber 701 for better fit by transition from the pleural cavity to the subcutaneous tissue. The transfer chamber 701 is shown as a cylinder having 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 with or attached to the wall of the cylinder, to which the intercostal pump 113 is connected. When placed on a patient, the intercostal pump 113 is placed in the intercostal space between the first and second ribs, and the transfer chamber 701 of the transfer fluid management system 106 using an intercostal pump is placed in the subcutaneous tissue under the skin and outside the bony rib cage. In this configuration and arrangement, with the patient's breathing, the intercostal pump 113 is periodically compressed and decompressed by the first and second ribs, as described for FIGS. 11A and 11B, thereby automatically providing a continuous pumping operation to the pump and a flow of body fluid from the pleural cavity to the peritoneal cavity. Further, in this configuration and arrangement, the transfer chamber 701 is placed outside the bony rib cage and provides a transition of approximately or substantially 90 degrees (or other suitable angle) from the pump inlet end 140 of the first tube 120 to the pump outlet end 142 of the second tube 122 for better fit by transition from the pleural cavity to the subcutaneous tissue. The flat first end 710 of the cylinder provides a stable interface between the transfer chamber 701 and the bony rib cage and helps maintain a stable positioning of the intercostal pump 113 in the intercostal space between the first and second ribs. The transfer chamber 701 is shown as a cylinder with flat ends, but can take any suitable shape that provides a transition of up to 90 degrees (or other suitable angle) from the pump inlet end 140 of the first tube 120 to the pump outlet end 142 of the second tube 122 and the stability of the intercostal pump. The transfer chamber 701 may be constructed of any relatively rigid or non-flexible material such as nylon, acrylic, polycarbonate, PEEK, ABS, PET, stainless steel or other suitable materials. However, if desired, it can also be made of a relatively more flexible material.FIG. 16B shows a cross-sectional schematic view of pump 113 and transition chamber 701 of a body fluid management system 106 using a transition automatic intercostal pump.

[0096] Another solution for better adaptation and providing stable positioning by transition between the pleural cavity and the subcutaneous tissue is shown in FIG. 17. In this embodiment, the transition chamber 701 is configured to engage with the bony thorax, which is possible and helps maintain a stable positioning of the intercostal pump 113 in the intercostal space between the first rib and the second rib and the orientation of the intercostal pump 113 with respect to the chest wall. In this case, the transition chamber 701 is a rounded diamond-shaped mechanism that provides a transition of approximately 90 degrees (or other suitable angle) from the pump inlet end 140 of the first tube 120 to the pump outlet end 142 of the second tube 122 and the stability of the intercostal pump. Although an approximately 90-degree transition as shown in FIG. 17 may be desirable, alternative transition angles are also possible, and one such alternative is shown in FIG. 18. Further, the general shape of the transition chamber 701 can have various possibilities as shown by the example of the flanged mushroom shape shown in FIG. 19. To fix the transition body fluid management system 106 using the automatic intercostal pump in a predetermined position, additional stability mechanisms such as holes 191 in the flanged mushroom-shaped transition chamber that allow tissue ingrowth or passage of sutures may be provided. In such a case, the mushroom-shaped flange portion or at least a part thereof may be configured such that the holes 191 in the flange portion do not penetrate the internal space 330.

[0097] e. Pleuroperitoneal Automatic Intercostal Pump with Manual Assist Device Another automatic intercostal pump adapted to the transition between the pleural cavity and the subcutaneous tissue and providing manual assistance to the pumping operation is shown in FIG. 20A. The transition fluid management system 107 using an automatic intercostal pump with a manual assist device includes an intercostal pump 113 connected to a transition chamber 702 for better adaptation to 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 opposite the flat first end 710 of the cylinder, and an outlet one-way valve frame 342 integrated with or attached to the wall of the cylinder to which the intercostal pump 113 is connected. In this embodiment, the transition chamber 702 body and the first flat end 710 may be constructed of any relatively rigid or non-flexible material such as nylon, acrylic, polycarbonate, PEEK, ABS, PET, stainless steel, or other suitable materials, and the domed second end 712 may be constructed of a deformable but elastic material such as polyurethane, silicone, polyvinyl chloride, latex rubber, or other suitable elastic materials that return to their original shape. When placed on the patient, the intercostal pump 113 is placed in the intercostal space between the first and second ribs, and the transition chamber 702 is placed in the subcutaneous tissue under the skin and outside the bony thorax. In this configuration and arrangement, with the patient's breathing, the intercostal pump 113 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 operation to the pump and a flow of body fluid from the pleural cavity to the peritoneal cavity. Further, in this configuration and arrangement, the transition chamber 702 is placed 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 for better adaptation to 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 702 and the bony thorax, and the elastic domed end 712 faces outward from the bony thorax and is placed in the subcutaneous tissue under the skin. Thus, the subcutaneous elastic domed end 712 can utilize periodic (or aperiodic) manual compression that can provide additional pumping operations as needed to supplement the flow of body fluid from the pleural cavity to the peritoneal cavity.Furthermore, if the material used to create the resilient dome-shaped end 712 of the transfer chamber 702 is self-sealing after puncture, the interior 330 of the transfer fluid management system 107 using an automatic intercostal pump with a manual assist device can be accessed to aspirate body fluid or inject anticoagulants, fibrinolytic agents, and / or other agents, for example, by passing a needle through the resilient self-sealing material of the dome-shaped end 712. The body and first flat end of the transfer chamber 702 may be constructed of any relatively rigid or non-flexible material, but additionally or alternatively, if desired, may also be made of a more flexible material. FIG. 20B is a schematic cross-sectional view of the pump 113 of the transfer fluid management system 107 using an automatic intercostal pump and the transfer chamber 702.

[0098] f. Pleuroperitoneal Automatic Intercostal Pump with Access Port Another automatic intercostal pump that is adapted for transition between the pleural cavity and subcutaneous tissue and provides an accessory access port 721 is shown in FIG. 20A. A transitional fluid management system 107' using an automatic intercostal pump with an access port includes an intercostal pump 113 connected to a transition chamber 702 for better adaptation to 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 an outlet one-way valve frame 342 integrated with or attached to the wall of the cylinder to which the intercostal pump 113 is connected. The accessory access port 721 is shown as a second domed cylinder with a domed end 722 adjacent to 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 as a result, is 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 non-flexible material such as nylon, acrylic, polycarbonate, PEEK, ABS, PET, stainless steel, or other suitable materials. The domed second end 712 of the transition chamber 702 may be constructed of polyurethane, silicone, polyvinyl chloride, latex rubber, or other suitably elastic material that is deformable and returns to its original shape. The domed septum 722 of the accessory access port 721 may be constructed of a specific type of polyurethane, silicone, latex rubber, or other suitable self-sealing material that can be sharply punctured for access but is capable of sealing the puncture. When placed on the 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 thorax. In this configuration and placement, with the patient's respiration, the intercostal pump 113 is periodically compressed and decompressed by the first and second ribs, as described for FIGS. 11A and 11B, thereby automatically providing a continuous pumping action to the pump and a flow of body fluid from the pleural cavity to the peritoneal cavity.Furthermore, in this configuration and arrangement, the transition chamber 702 is disposed 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 conform to 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 702 and the bony thorax, and the elastic dome-shaped end 712 faces outward from the bony thorax and is disposed in the subcutaneous tissue under the skin. Thus, the subcutaneous elastic dome-shaped end 712 can utilize periodic (or aperiodic) manual compression that can provide additional pumping action as needed to supplement the flow of body fluid from the pleural cavity to the peritoneal cavity. Further, the self-sealing dome-shaped partition 722 of the accessory access chamber 721 is accessible under the patient's skin by puncturing with a needle, thereby directly connecting to the internal 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 collecting contents within the internal space 330 or for injecting anticoagulants, fibrinolytic agents, and / or other agents into the internal space 330 of the transition chamber 702. It should be noted that during collection from the internal space 330, negative pressure may occur during the collection process, thereby causing the inlet valve 320 to open and allowing body fluid to flow from the pump inlet end 140 of the first tube 120, enabling indirect collection of the contents within the first tube 120. Similarly, during injection of anticoagulants, fibrinolytic agents, and / or other agents into the internal space 330, positive pressure may occur during the injection process, thereby causing the outlet valve 322 to open and allowing body fluid to flow into the pump outlet end 142 of the second tube 122, which may also enable delivery of anticoagulants, fibrinolytic agents, and / or other agents to the contents within the second tube 122. The body of the transition chamber 702 and the first flat end may be constructed of any relatively rigid or non-flexible material, but additionally or alternatively, it can also be made of a more flexible material as needed.

[0099] This concept of using an accessory access port to access the interior of the transitional fluid management system 107' with an access port 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 mechanism or other suitable shaped mechanism capable of engaging the bony thorax, thereby maintaining a 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 partition 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 partition 722'' in fluid communication with the interior of the pump inlet end 140 of the first tube 120. Thus, by crossing the overlying skin and then crossing the first self-sealing dome-shaped partition 722' of the first accessory access chamber 721', body fluid can be collected, or anticoagulants, fibrinolytic agents and / or other agents can be selectively injected into the interior space 330 of the transition chamber 702. Similarly, by crossing the overlying skin and then crossing the second self-sealing dome-shaped partition 722' of the second accessory access chamber, body fluid can be selectively collected, or anticoagulants, fibrinolytic agents and / or other agents can be injected into the interior of the pump inlet end 140 of the first tube 120.

[0100] g. Design of the pleuroperitoneal electromechanical automatic pump Referring to FIG. 23A, a body fluid management system 108 using an electromechanical automatic pump for the movement of body fluid from a first body compartment to a second body compartment generally includes a pump 118 having an inlet 130 and an outlet 132, and body fluid can move between the inlet 130 and the outlet 132. The body fluid management system 108 using an electromechanical automatic pump also includes a first tube 120 and a second tube 122. The inlet 130 and the outlet 132 communicate between the inside and the outside of the pump 115 respectively and are connected 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 each of the first tube 120 and the second tube 122 and the internal space of the pump 118.

[0101] Furthermore, the first tube 120 may include a plurality of perforations or openings 170 that allow the inflow of body fluid into the first tube 120 and the pump inlet end 140. Generally, the first tube 120 is configured such that when in use, the perforations 170 are disposed in the region of the human body from which the body fluid is discharged. On the other hand, the pump inlet end 140 is connected to the inlet 130 of the pump 118. The length of the first tube 120 may vary as indicated by the length extension 160.

[0102] 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 when using the body fluid management system 108 using an automatic pump, the tube outlet end 152 is disposed in the region of the human body to which the body fluid is discharged. On the other hand, the pump outlet end 142 is connected to the outlet 132 of the pump 118. The length of the second tube 122 may vary as indicated by the length extension 162.

[0103] FIG. 23B is a schematic cross-sectional view of the body fluid management system 108 using an electromechanical automatic pump in a non-operating 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 surrounding an internal space 330 with the inlet one-way valve 320 and the outlet one-way valve 322.

[0104] The inlet valve 320 may be located in the internal space 330 of the pump body that is approximately close 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, for example, silicone. The inlet one-way valve 320 is configured to prevent the movement of body fluid from the internal space 330 of the pump 118 to the inlet 130. At the same time, the inlet one-way valve 320 is configured to allow the movement of body fluid from the inlet 130 to the internal space 330 of the electromechanical pump 118. In other words, the inlet one-way valve 320 is in fluid communication with the inlet 130 so as to generally provide a one-way movement of body fluid from the inlet 130 to the internal space 330 of the electromechanical pump 118.

[0105] Accordingly, the outlet one-way valve 322 may be located in the internal space 330 of the pump body that is approximately close 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, for example, silicone. The outlet one-way valve 322 is configured to allow the movement of body fluid from the internal 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 the movement of body fluid from the outlet 132 to the internal space 330 of the electromechanical pump 118. In other words, the outlet one-way valve 322 is in fluid communication with the outlet 132 so as to generally provide a one-way movement of body fluid from the internal space 330 of the electromechanical pump 118 to the outlet 132.

[0106] The inlet one-way valve frame 340 and the outlet one-way valve frame 342 may be integrated with or attached to the body of the electromechanical pump 118 and may be on the outer periphery of the inlet one-way valve 320 and the outlet one-way valve 322. Further, the size and shape of the inlet one-way valve frame 340 and the outlet one-way valve frame 342 can be selected to provide a joint or an interconnectable joint between the first tube 120 and the second tube 122.

[0107] The inlet one-way valve 320 and the outlet one-way valve 322 are shown as being located within the internal space 330 of the intercostal pump 118, but it should be noted that alternative arrangements of the valves may be desirable in some cases. For example, one or both of the inlet one-way valve 320 and the outlet one-way valve 322 may be located outside of 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 specific arrangement of the valves is not necessarily critical as long as it substantially and adequately provides for the one-way flow of body fluid into and out of the intercostal pump 111.

[0108] In the electromechanical pump 118, the liquid-impermeable membrane 550 separates the interior 330, which is in fluid communication with the inlet check valve 320 and the outlet check valve 322, from the 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 actuated and deactuated by the controller 530, and both the piezoelectric diaphragm 540 and the controller 530 may use the battery 510 as a power source. As shown in FIG. 23B, the piezoelectric diaphragm 540 is in a deactivated state, and both the inlet check valve 320 and the outlet check valve 322 are closed. As shown in FIG. 23C, when the controller 530 actuates the piezoelectric diaphragm 540, the piezoelectric diaphragm 540 changes shape so as to strike the interior 330 of the electromechanical pump 118, deforming the membrane 550. This reduces the available volume of the body fluid in the interior 330, increases the pressure within the interior 330, opens the outlet check valve 322, and moves the body fluid from the interior 330 of the electromechanical pump 118 to the pump outlet end 142 of the second tube 122 and ultimately to the tube outlet end 152 of the second tube 122. When the controller 530 deactivates the piezoelectric diaphragm 540, as shown in FIG. 23D, the piezoelectric diaphragm 540 returns to its original shape, and the membrane 550 returns to its original shape. This increases the available volume of the body fluid in the interior 330 of the electromechanical pump 118, decreases the pressure within the interior 330, thereby closing the outlet check valve 322 and opening the inlet check valve 320, and causing the body fluid to move from the interior of the pump inlet end 140 of the first tube 120 to the interior 330 of the electromechanical pump 118. In this way, the body fluid is pumped by the periodic actuation and deactivation of the piezoelectric diaphragm 540.

[0109] In the specific situation of recurrent malignant pleural effusion where treatment to suppress symptoms is required, 25% of patients die by the end of 12 weeks of daily drainage, and 50% of patients have achieved pleural adhesions in the pleural cavity following repeated drainage, thus stopping the drainage of body fluids [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 exudate from the pleural cavity daily provides appropriate treatment for 75% of patients with malignant pleural effusion. The amount of pleural fluid that must be drained can vary greatly from patient to patient and from day to day, and generally, the drainage volume of exudate decreases with each subsequent drainage. The typical drainage volume of exudate over 12 weeks can start at about 500 ml per day and decrease to about 0 ml per day. Assuming that the decrease in drainage volume is represented by the following first - order differential equation dV / dt=-λV (where dV is the drainage volume during a small time interval dt, V is the drainage volume, λ is the decay constant) and solving this equation gives an exponential decay of drainage of the following form V(t)=V0e -λt (where V(t) is the drainage volume on a specific day t, V0 is the drainage volume on day 0) is obtained. Assuming that the initial drainage volume on day 0 is 500 ml and the decay constant is 1 / 28, the drainage will be less than 25 ml per day after 12 weeks, and the total drainage volume will be 13.5 liters. Similarly, if the initial drainage on day 0 is excessive at 1000 ml, assuming the same decay constant of 1 / 28, the drainage will be less than 50 ml per day after 12 weeks, and the total drainage volume will be 27.1 liters. Therefore, if a system that can pump 27 liters of body fluid over 12 weeks is designed, it will meet the drainage requirements of the majority of malignant pleural effusion patients during those 12 weeks, and at least 75% of the patients will not require further intervention. The desired daily drainage value based on this or any other desired relationship can be entered into a look-up table used for controlling an electromechanical pump. By decreasing the volume pumped daily over time, the lifespan of the power source can be extended.

[0110] The work that the pump must do to move body fluid through the tube from the first position to the second position can be derived from Bernoulli's equation and is shown as follows.

[0111]

Number

[0112] (where E pump is the energy per unit mass that the pump imparts to the body fluid, and P1 is the pressure at position 1, and P2 is the pressure at position 2, and ρ is the density of the body fluid, and

[0113]

Number

[0114] is the average velocity of the body fluid at position 1, and

[0115]

Number

[0116] is the average velocity of the body fluid at position 2, g is the gravity acting on the body fluid, z1 is the height of the body fluid at position 1, z2 is the height of the body fluid at position 2, E friction is the energy loss due to friction when the body fluid flows through the tube.) The main frictional losses for moving the body fluid through the tube from the first position to the second position can be derived as follows.

[0117]

Number

[0118] (In the formula, E friction is the main energy loss due to friction when the body fluid flows through the tube, f is the friction coefficient of the tube,

[0119]

Number

[0120] is the average velocity of the body fluid when it passes through the tube, L is the length of the tube, d is the diameter of the tube.) Combining these two equations gives the following.

[0121]

Number

[0122] To determine the energy required by the electromechanical pump 118 to move the effusion from the first region 220, which is the pleural cavity of the patient, to the second region 230, which is the peritoneal cavity of the patient, a simplified state can be considered where both the first position and the second position are at the same height, the body fluid is at rest at the first position, and the pressure at the second position is greater than the pressure at the first position. In this state, the energy equation of the pump is simplified as follows.

[0123]

Number

[0124] The following relational expression

[0125]

Number

[0126] (where Q2 is the volumetric flow rate of the body fluid through the tube, k is a correction factor taking into account the velocity profile) Replacing the average velocity in the tube with the volumetric flow rate, the energy equation of the pump becomes as follows.

[0127]

Number

[0128] Examining the above equation, it can be seen that when the diameter of the tube is relatively small, the energy of the pump depends greatly on the diameter of the tube. For these terms regarding the pleural cavity, peritoneal cavity, and potential design characteristics, the following examples of typical values may be considered.

[0129] P1 (intrapleural pressure) = -5 cmH2O = 490 Pa, P2 (intraperitoneal pressure) = +20 cmH2O = 1961 Pa, ρ (density of the effusion) = 1,000 kg / m 3 , Q2 (average volume flow rate of body fluid at 100 ml / min at position 2) = 1.667×10 -6 m 3 / s, f (friction coefficient of silicone tube) = 0.5, k (turbulence correction factor) = 1, L (length of the tube connecting the first position and the second position) = 30 cm = 0.3 m, and d (diameter of the tube) = 3 mm = 0.003 m.

[0130] Substituting these representative values into the equation gives the following.

[0131]

Equation

[0132] E pump = 2.451 + 0.0278 + 5.562 = 8.041 Nm / kg Therefore, using the above assumptions, based on this simplified model, 8.041 J of energy is consumed per 1 kilogram of the mass of the exudate moving from the first region 220 to the second region 230 of the patient.

[0133] To further refine this model, a second friction term is added to the above equation considering a narrow connection with a length of 1 cm and a diameter of 1 mm, and the following is obtained. E pump = 2.451 + 0.0278 + 5.562 + 45.05 = 53.09 Nm / kg Interestingly, a 1 cm long and 1 mm diameter connection contributes 8 times (8X) the frictional energy of a 30 cm long and 3 mm diameter tube. From this, using the modified assumptions outlined above that include a 1 cm tube and 1 mm stenosis, it can be seen that 53.09 J of energy is consumed per 1 kilogram of the mass of the exudate moving from the patient's first region 220 to the patient's second region 230. Further, for an electromechanical pump 118 operating at 50% efficiency, 106.2 J of energy must be supplied to move 1 kg of exudate. Thus, it is desirable that the power source be able to supply at least 2,866.9 J over the first three months during which it is assumed that 27 liters of exudate must be moved. Further, for higher frictional losses in the tube (especially considering the tube diameter), and for lower efficiencies, and to allow for a greater pressure gradient between the patient's first region 220 and second region 230, it is preferably desirable that the power source be able to supply at least about 5,000 J of energy, more preferably at least about 10,000 J of energy, and even more preferably about 15,000 J of energy. For reference, a AA battery rated at 2800 mAH and operating at 1.5 V contains 15,120 J of energy.

[0134] Furthermore, since it strongly depends on E for the diameters of the tubes and connections necessary to transfer body fluid between the first region 220 and the second region 230 Pump The body fluid management system 108 using an electromechanical automatic pump may desirably have all tube diameters, connection diameters, and opening diameters (regardless of the operation (e.g., opening and closing) of the one-way valve) of 1 mm or more, preferably 2 mm or more, more preferably 3 mm or more, and even more preferably 4 mm or more. Alternatively, it may be desirable to limit the lengths of the 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.

[0135] The activation and operation of the electromechanical pump 118 can be optimized based on the requirements for the movement of body fluids between the patient's first region 220 and second region 230. For the pleural cavity to the peritoneal cavity outlined above, the requirements for exudate movement can be 500 ml on the first day and decreased to less than 25 ml by the 84th day over time, or 1 liter on the first day and decreased to less than 50 ml by the 84th day over time. In such a situation, the controller 530 can be programmed to turn on the pump for a period based on the pump's processing capacity that pumps the required amount of body fluid on the first day and then decreases the time the pump is on each subsequent day according to, for example, the following relational expression V(t)=V0e -λt (where V0 is (as an example) 1 liter, λ is 1 / 28, t is the number of days after implantation). Alternatively, the pump-on time can be based on a look-up table implemented using the desired daily drainage volume. The electromechanical pump 118 may be turned on once a day to pump the entire required amount of body fluid at one time, or the total pump-on time may be divided throughout the day. For example, the electromechanical pump 118 may be turned on once an hour to pump approximately 1 / 24 of the desired total daily drainage volume. Other patterns of pump-on time and pump-off time may also be used.

[0136]

[0137] Furthermore, the controller 530 can be designed to include a detection mechanism that can monitor the flow of body fluid when the electromechanical pump 118 is on, and can turn off the electromechanical pump 118 when the flow of body fluid stops. For example, if the initial estimated or desired amount on the first day is 1 liter, but the flow stops after 550 ml of body fluid is pumped, the controller 530 can be programmed to stop the electromechanical pump 118. Alternatively, the electromechanical pump 118 can be simply turned on every hour or at other appropriate intervals, and kept on until the flow of body fluid drops below a predetermined value, such as, but not limited to, 1 ml / min or 5 ml / min. Additionally, the controller 530 can be designed to include a detection mechanism that can monitor the pressure inside the pump while the electromechanical pump 118 is on, and can be programmed to turn off the electromechanical pump 118 when the pressure inside the pump drops below a predetermined value. For example, the controller may turn off the electromechanical pump 118 when the pressure drops below about 5 cmH2O, about 0 cmH2O, about -5 cmH2O, about -10 cmH2O, or about -20 cmH2O.

[0138] In the electromechanical pump 118, although the electromechanical actuator 540 has been described as a piezoelectric diaphragm, in order to achieve a similar operation, alternative actuators for diaphragm pumps such as, but not limited to, electric motors and cams can be used among other alternative means. In fact, 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.

[0139] h. Design of a pleuroperitoneal electromechanical automatic intercostal pump Referring to FIGS. 24A and 24B, a fluid management system 109 using a combined electromechanical automatic intercostal pump incorporating an intercostal pump 113 that operates as described with respect to FIGS. 11A and 11B, for example, and an electromechanical pump 118 as described with respect to FIGS. 23A-23D, for example, is shown. These pumps may share a common interior 330, an inlet check valve 320, and an outlet check valve 322. During operation, the intercostal pump 113 may be periodically compressed and decompressed between the first and second ribs to create a continuous flow of body fluid between the pump inlet 130 and the pump outlet 132. The electromechanical pump 118 can be configured to supplement the flow of body fluid as needed.

[0140] 5. Fluid Management Systems Using Other Automatic Pumps A fluid management system including an automatic pump 110 may be used to transport and drain body fluid in various regions of a patient's body. That is, a fluid management system including an intercostal pump as described herein is not limited to use related to draining body fluid from a patient's pleural cavity to the patient's peritoneal cavity.

[0141] One example of an alternative use of a fluid management system incorporating an intercostal pump as described herein is the drainage of body fluid from a patient's cerebrospinal region. Based on this alternative use, the tube 120 may be configured to extend from the automatic pump 110 to the patient's cerebrospinal region such that the tube inlet end 150 is disposed in the patient's cerebrospinal region. In this way, excess cerebrospinal fluid may be drained.

[0142] Another example of an alternative use of a fluid management system incorporating an intercostal pump as described herein is the drainage of body fluid from a patient's pericardial region. Other alternative uses are of course possible. Generally, a fluid management system incorporating an intercostal pump as described herein may be used to transport and drain body fluid in any combination of regions within a patient's body where sufficient fluid communication can be established with a fluid management system 100 using any of the automatic intercostal pumps described herein.

[0143] 6. Humor Management System with Reservoir Using Automatic Pump Referring to FIG. 25, there is shown a humor management system 1000 using an automatic intercostal pump, in which at least a part of a pump 1010, a first tube 120 in a patient's body 200, and at least a part of a second tube 122 located outside the patient's body are embedded to provide drainage of humor from a first region 220 in the patient's body to an external reservoir 1020 located outside the patient's body. In one embodiment, similar to the example of the embodiment shown in FIG. 25, the humor is drained from the patient's pleural cavity 220 to the external reservoir 1020.

[0144] In one embodiment, the automatic intercostal pump 1010 is configured to be disposed at least in part in an intercostal region between two ribs. In other words, when embedded, the intercostal pump 1010 extends through the patient's intercostal space, or a part thereof. Accordingly, the first tube 120 and correspondingly the pump inlet 130 are disposed inside the patient's bony thorax. The second tube 122 and correspondingly the pump outlet 132 are disposed outside the patient's bony thorax. Thus, due to breathing and the corresponding compression / decompression of the bony thorax, the patient 210 will automatically operate (e.g., "pump") the intercostal pump 1010. With this configuration, while the humor in the pleural cavity is actively drained, the patient can move around with minimal hardware on.

[0145] 7. Method for Draining Humor in a Patient's Body Using a Humor Management System with Automatic Pump A method of draining body fluid from a first region of a patient or a human body to a second region of the patient or the human body may generally be implemented by implanting and using any of the various automatic pumps of the body fluid management system described herein. Referring to FIGS. 26A and method 800, with regard to an example of a method for draining pleural effusion, at step 802, an intercostal pump (such as 110, 111, 112, etc.) of a body fluid management system using an automatic pump, for example, any of the various embodiments described herein, is implanted into the intercostal space of the patient such that the pump is compressed between a first rib (such as 412) and a second rib (such as 414). The intercostal pump (such as 110, 111, 112, etc.) may be implanted using any suitable known or unknown surgical technique. At step 804, fluid communication is established between a first region of the patient and an inlet 130 of the intercostal pump (such as 110, 111, 112, etc.). For example, a first tube (such as 120) may extend from the pleural cavity of the patient to the inlet 130. At step 806, fluid communication is established between a second region of the patient and an outlet 132 of the intercostal pump (such as 110, 111, 112, etc.). For example, a second tube (such as 122) may extend from the outlet 132 to the peritoneal cavity of the patient. At step 808, the intercostal pump (such as 110, 111, 112, etc.) is periodically compressed and electromechanically pumped or periodically compressed or electromechanically pumped to move body fluid from a first region of the patient through the first tube and into a second region of the patient through the second tube through the intercostal pump, depending on which of the various embodiments described above is used.

[0146] For example, an intercostal pump (e.g., 110, 111, 112, etc.) may be compressed between the first rib (e.g., 412) and the second rib (e.g., 414) during the patient's respiratory cycle. Specifically, referring to FIGS. 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 first compressed between the first rib 412 and the second rib 414 while the patient's ribs are in a contracted state (i.e., the patient has already exhaled). 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. At step 854, the intercostal pump (e.g., 110, 111, 112, etc.) draws in body fluid. That is, as a result of decompressing the intercostal pump (e.g., 110, 111, 112, etc.) at step 852, body fluid is drawn into the internal space (e.g., 330) of the intercostal pump (e.g., 110, 111, 112, etc.) by the pumping force. At step 856, the intercostal pump (e.g., 110, 111, 112, etc.) is compressed. For example, the intercostal pump (e.g., 110, 111, 112, etc.) is compressed between the first rib 412 and the second rib 414 as a result of the patient's bony thorax contracting (i.e., the patient exhaling). When the patient exhales, the bony thorax contracts and the first rib 412 and the second rib 414 move towards each other. As a result, the intercostal pump (e.g., 110, 111, 112, etc.) is compressed. At step 858, the intercostal pump (e.g., 110, 111, 112, etc.) discharges body fluid. That is, as a result of compressing the intercostal pump (e.g., 110, 111, 112, etc.) at step 856, body fluid is forced out of the internal space (e.g., 330) of the intercostal pump (e.g., 110, 111, 112, etc.) by the pumping force. Depending on the method, an electromechanical pump (e.g., 118) may be used instead of or in addition to the intercostal pump (e.g., 110, 111, 112, etc.).

[0147] 8. Others As used herein, the terms "substantially" or "approximately" refer to the complete or nearly complete scope or degree of an action, characteristic, property, 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 specific context. However, generally speaking, the proximity to completeness is such that it produces approximately the same overall effect or result as if absolute and total completeness had been achieved. The use of "substantially" or "approximately" is equally applicable when used in a negative sense to refer to a complete or nearly complete absence of an action, characteristic, property, state, structure, item, or result.

[0148] Unless otherwise specified, as used herein, the phrase "at least one of [X] and [Y]" or "at least one of [X] or [Y]" means that, when [X] and [Y] are different components that may be included in an embodiment of the present 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 those three or more components, any combination or sub - combination of those components, or all of those components.

[0149] Examples of embodiments of the body fluid management system using an automatic pump have been described above. They are not intended to be exhaustive or to limit the invention to the exact forms disclosed. Obvious modifications or variations are possible in light of the above teachings. The various embodiments are selected and described in order to provide the best illustration of the principles of the present disclosure and their practical application, and to enable one of ordinary skill in the art to utilize the various embodiments with various modifications suitable for the particular use contemplated. All such modifications and variations are within the scope of the present disclosure as determined by the appended claims when fairly, legally, and equitably construed to fall within the scope of the rights granted.

Claims

1. An electromechanical pump in fluid communication with an inlet and an outlet, a first tube extending from the inlet and configured to enable movement of body fluid from a first region of a patient's body to the inlet, a second tube extending from the outlet and configured to enable movement of body fluid from the outlet to a second region of the patient's body comprising a body fluid management system using an electromechanical pump, wherein the electromechanical pump an actuator capable of moving body fluid from the inlet to the outlet, a controller operably connected to the actuator and capable of controlling the actuator, a battery operably connected to the controller and providing energy to the controller and the actuator A body fluid management system using an electromechanical pump including.

2. A one-way valve is located substantially adjacent to one of the inlet or the outlet and is configured to prevent backflow from the outlet to the inlet. The body fluid management system using the electromechanical pump according to claim 1.

3. The battery is configured to contain sufficient energy for the electromechanical pump to move at least 27 liters of body fluid from the inlet to the outlet. The body fluid management system using the electromechanical pump according to claim 1 or 2.

4. The controller is programmed to operate the actuator a plurality of times over a first period and to continue to operate the actuator for a specific period shorter than the first period for each of the plurality of times. The body fluid management system using the electromechanical pump according to claim 1 or 2.

5. The controller is programmed to operate the actuator for a time to pump the required amount of body fluid on the first day after implantation of the body fluid management system using the electromechanical pump into a patient user, and then to reduce the time the pump operates the actuator for at least one day after implantation. The body fluid management system using the electromechanical pump according to claim 1 or 2.

6. The system for body fluid management using the electromechanical pump according to claim 1 or 2, further comprising a sensor for detecting body fluid flowing through the electromechanical pump, wherein the controller is programmed to operate the actuator a plurality of times over a period of time, and for each of the plurality of times, continue to operate the actuator until the sensed body fluid flow rate falls below a predetermined value.

7. The system for body fluid management using the electromechanical pump according to claim 1 or 2, further comprising a sensor for detecting the pressure inside the electromechanical pump, wherein the controller is programmed to operate the actuator a plurality of times over a period of time, and for each of the plurality of times, continue to operate the actuator until the sensed pressure falls below a predetermined value.

8. The electromechanical pump comprises a pump body having an internal chamber in fluid communication with the inlet and the outlet, an inlet one-way valve disposed substantially adjacent to the inlet, configured to allow movement of body fluid from the inlet to the internal chamber and at least substantially prevent movement of body fluid from the internal chamber to the inlet, an outlet one-way valve disposed substantially adjacent to the outlet, configured to allow movement of body fluid from the internal chamber to the outlet and at least substantially prevent movement of body fluid from the outlet to the internal chamber, a liquid-impermeable membrane separating the internal chamber from a storage compartment containing the actuator, the controller, and a battery and the system for body fluid management using the electromechanical pump according to claim 1, wherein the actuator is operably connected to the liquid-impermeable membrane and is capable of deforming the liquid-impermeable membrane.

9. The system for body fluid management using the electromechanical pump according to any one of claims 1, 2, or 8, wherein at least a portion of at least one of the electromechanical pump, the inlet, the outlet, the first tube, or the second tube is coated with at least one of an anticoagulant factor or a fibrinolytic factor.

10. The system for body fluid management using the electromechanical pump according to claim 9, wherein at least a portion of at least one of the electromechanical pump, the inlet, the outlet, the first tube, or the second tube is coated with heparin.

11. A body fluid management system using the electromechanical pump according to claim 10, wherein at least a part of the electromechanical pump is coated with heparin.

12. An electromechanical pump in fluid communication with an inlet and an outlet, an actuator capable of moving body fluid from the inlet to the outlet, and a battery operably connected to the actuator to provide energy to the actuator An electromechanical pump comprising A body fluid management system using an electromechanical pump, comprising A body fluid management system using an electromechanical pump, wherein at least a part of the electromechanical pump is coated with heparin.

13. A first tube extending from the inlet and configured to allow movement of body fluid from a first region of a patient's body to the inlet; A second tube extending from the outlet and configured to allow movement of body fluid from the outlet to a second region of the patient's body The body fluid management system using the electromechanical pump according to claim 12, further comprising

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