Direct sodium removal method, solution and apparatus to reduce fluid overload in heart failure patients

Abstract

To provide a direct sodium removal method, apparatus and solution for treating patients in heart failure, the patients having a glomerular filtration rate greater than 15 mL / min / 1.73 m2, or having residual kidney function corresponding to normal to CKD Stage 4.SOLUTION: A no or low sodium DSR infusate is administered to the peritoneal cavity for a predetermined dwell period and then removed, thereby removing sodium from the body. The resulting elimination of fluid from the patient by i) functioning of the kidneys through urination and ii) direct removal of osmotic ultrafiltrate from the peritoneal cavity, restores serum sodium concentrations to healthy levels and thereby reduces fluid overload in the patient.SELECTED DRAWING: Figure 1A

Description

[Technical Field]

[0001] (Cross-reference of related applications) This application, filed on May 24, 2017, is incorporated herein by reference in its entirety. This application seeks to claim the benefit of priority from National Provisional Application No. 62 / 510,652.

[0002] (Field of invention) This invention generally involves administering the solution into the patient's peritoneal cavity to directly remove sodium from the body. Removing excess body fluid to alleviate fluid overload in heart failure patients with residual renal function. (Anea or hyponatremia) Regarding the use of the injection fluid (hereinafter referred to as DSR injection fluid). This method, DSR injection fluid, and apparatus are: It functions to remove excess body fluid by removing sodium. Sodium is (1) limited It is transferred to the peritoneal cavity by either or both external filtration and / or (2) diffusion in a steep concentration gradient. It is then removed from there. The liquid is (1) osmotic ultrafiltration ) to induce the movement of bodily fluids from the patient's body to the abdominal cavity and remove them there, and / or ( 2) By promoting the excretion of excess body fluids via the kidneys through urination, or by either or both of the above. It is then removed from the body to maintain a relatively stable serum sodium concentration. [Background technology]

[0003] (background) Patients suffering from any of several forms of heart failure may require additional sodium in their body tissues. It tends to accumulate, and as a result, the amount of bodily fluids increases. For example, in congestive heart failure, the heart Dysfunction on the left side, right side, or both sides can prevent the body from pumping blood at a normal efficiency. Wounds, sodium retention, and stagnation or retention of blood or body fluids in the lungs or liver. This can lead to decreased systemic circulation, edema, and / or cardiac hypertrophy.

[0004] The Centers for Disease Control and Prevention (CDC) estimates that approximately 5.7 million people in the United States suffer from some form of heart failure. It is estimated that heart failure is generally classified into four different stages, the most severe being end-stage heart failure. End-stage heart failure is defined as a condition in which a patient exhibits symptoms of heart failure at rest despite medical treatment. It can be diagnosed in cases where the patient has systolic heart failure characterized by a reduced ejection fraction. Yes. In patients with systolic heart failure, the ventricular walls are weaker and do not compress as strongly as in healthy patients. As a result, during systole, the reduced amount of oxygenated blood is expelled into the circulation, and this condition persists until death. It continues in a spiral pattern. Alternatively, the patient may have diastolic heart failure and a stiffened heart. Alternatively, thickened heart muscle makes it difficult to fill the affected heart chambers with blood. End-stage heart failure The one-year mortality rate for patients diagnosed with this condition is approximately 50%.

[0005] Renal failure, also known as chronic kidney disease ("CKD"), allows for the estimation of glomerular filtration rate ("GFR"). It is diagnosed by a blood test that measures blood urea nitrogen ("BUN") and creatinine. GFR is calculated using the CKD-EPI creatinine formula (2009) or the CKD-EPI creatinine-cystatin formula ( It is a comprehensive index of renal function calculated by one of several well-known formulas, such as the one mentioned in 2012. Consider the patient's serum creatinine, age, sex, and race. For example, GFR is C It can be calculated using the KD-EPI creatinine formula (2009): eGFR = 141 × min(S) Cr / κ, l) α ×max(S Cr / κ, l) -1.209 ×0.993 Age ×1.018 [Women's For [case] × 1.159 [for black people] In the formula: eGFR (Estimated Glomerular Filtration Rate) = mL / min / 1.73 m 2 S Cr (Standardized Serum Creatinine) = mg / dL κ = 0.7 (female) or 0.9 (male) α = -0.329 (female) or -0.411 (male) min = S Cr Indicates the minimum value of S / κ or 1 max = S Cr Indicates the maximum value of S / κ or 1 age = age The above formula is available on the website of the National Kidney Foundation at https: / / www.kidney.org / content / ckd - epi - creatinine - equation - 2009

[0006] Generally, the assessment of the severity of CKD is based on the calculated GFR value together with the following table:

Table 1

[0007] Typically, patients with severely reduced kidney function, generally stage 5, can no longer remove metabolic waste products from the blood sufficiently by the kidneys. In this case, they undergo dialysis to remove the metabolic waste products. Dialysis can be achieved using either an extracorporeal machine or peritoneal dialysis. As a first option [[ID=4⑥]]the patient is connected to a hemodialyzer, in which case the blood is sent from the body to the extracorporeal machine, purified and then returned to the patient's body. In peritoneal dialysis, a cleansing fluid or dialysate is injected into the patient's abdomen, and the metabolic waste products move from the arteries and veins in the abdomen into the dialysate over a specific period, for example, 30 - 45 minutes and then the dialysate is drained from the abdomen and discarded. Typically, patients perform 24 each This process of time can be repeated from 3 to 5 times.

[0008] Low-sodium dialysate is used for patients with end-stage renal disease who require dialysis to treat CKD and is known to be used. For example, U.S. Patent No. 5,589,197 to Shockley et al. describes a dialysate for use in peritoneal dialysis having a sodium concentration of about 35-125 meq / L. As described in this patent, the sodium concentration in the solution is reduced to a level lower than the plasma sodium concentration of the patient, whereby sodium can be transported from the circulation to the peritoneal cavity. Unfortunately, such low-sodium dialysates have problems including the dialysis disequilibrium syndrome, a potentially fatal complication that results in the worsening of blood pressure symptoms, and in some cases, cerebral edema, lethargy, and death. See, for example, the paper by Nakayma, "Clinical Effect of Low Na Concentration Dialysate (120 mEq / L) for CAPD Patients" (PD Conference, San). See also, for example, the paper by Zepeda-Orozco D and Quigley R., "Dialysis disequilibrium syndrome" (Pediatric Nephrology (Berlin, Germany) 2012;27(12):2205-2211). Considering past experience with low-sodium dialysates, patients with end-stage renal disease who undergo dialysis regularly rely on treatments to optimize their salt and water levels. Currently reported (Clinical Effect of Low Na Concentration Dialysate (120 mEq / L) for CAPD Patients s)」(PD Conference, San) be referred to. For example, see the paper by Zepeda-Orozco D and Quigley R. of "Dialysis disequilibrium syndrome" (Pediatric Nephro logy (Berlin, Germany) 2012;27(12):2205-2211).

[0009] The average sodium concentration in dialysate is generally about 132 mMol / L. For example, Hecking The paper "Sodium setting values" by M, Kainz A, Horl WH, Herkner H, and Sunder-Plassmann G. and sodium gradient: Changes in plasma sodium and their effects on weight gain (Sodium setpoint t and sodium gradient: influence on plasma sodium change and weight gain.)”(A American Journal of Nephrology 2011;33(1):39-48);Mc Causland FR, Brunelli SM, and Waikar SS.'s paper "Dialysis fluid sodium, serum sodium, and in maintenance hemodialysis" Mortality (Dialysate sodium, serum sodium and mortality in maintenance hemodialysis See "Nephrology Dialysis Transplantation 2012;27(4):1613-8".

[0010] Decades of experience with dialysate sodium concentrations higher than the patient's blood sodium levels Such dialysates promote fluid removal during dialysis without removing sodium, It has been shown to improve the possibility of maintaining normal blood pressure and cardiac function. However, Furthermore, if sodium levels are high, patients undergoing hemodialysis often experience complications in their blood and dialysis. The dialysis will involve a positive sodium gradient between the precipitates. For example, Munoz Mendoz The paper by a J, Sun S, Chertow G, Moran J, Doss S, and Schiller B, titled "Maintenance hemodialysis Dialysis fluid sodium and sodium gradient: An approach that ignores sodium restriction? (Di alysate sodium and sodium gradient in maintenance hemodialysis: a neglected sodi (Nephrology Dialysis Transplantation 2011;26(4):128 See 1-7). Therefore, patients often have no problems by the end of their dialysis session. Thorium levels increase, resulting in increased thirst, fluid consumption, and high blood pressure. Therefore, weekly The final outcome for patients undergoing multiple hemodialysis sessions is chronic sodium and There is an excess of water.

[0011] The applicant argues that resolving fluid overload is an important clinical objective in heart failure, and However, we observed that it could lead to serious clinical complications, including respiratory distress. For example, This is described in the Textbook of Medical Physiology by Guyton and Hall. As described above, the body maintains a constant serum osmotic pressure and maintains its sodium level. Because it acts in such a way, in order to achieve an effective reduction of body fluids, it is necessary to remove sodium from the body. There is a need for this. Therefore, sodium is removed using a sodium-free or low-sodium injection solution, and by this It is desirable to develop a method to remove bodily fluids from patients and treat fluid overload in heart failure patients. It would be. [Overview of the project] [Means for solving the problem]

[0012] (Summary of the invention) This invention removes sodium using a sodium-free or low-sodium DSR infusion solution administered intraperitoneally. This removes bodily fluids from the patient's body, thereby reducing fluid excess, and is performed by those with residual renal function. Regarding methods for treating fluid overload in heart failure patients. Sodium is (1) ultrafiltration and / or (2) It is moved into the peritoneal cavity by one or both of the diffusion of a steep concentration gradient, and thereafter It is removed. The liquid is (1) subjected to osmotic ultrafiltration to remove body fluids (osmotic ultrafiltrate). To move sulfiltrate)) from the patient's body to the abdominal cavity and remove it therefrom, and / or (2 ) By either or both of the following: promoting the excretion of excess body fluids via the kidneys through urination, It is removed from the body to maintain a relatively stable serum sodium concentration. Therefore, this invention... This removes sodium from the body, thereby preventing hyponatremia, and also reduces fluid intake. It helps maintain relatively stable serum sodium levels and reduces fluid overload and edema.

[0013] According to the principles of the present invention, a patient suffering from heart failure may receive a low sodium dose administered intraperitoneally. Alternatively, treatment is performed (intermittently or continuously) using a sodium-free DSR infusion. Exemplary form So, D-10 dextrose solution, that is, 10 grams of dextrose per 100 ml of aqueous solution. DSR infusion fluid, which may contain [specific substances], can remain in the peritoneal cavity for a predetermined period before being removed, and then... Then, it is removed from the patient's body along with the sodium and osmotic ultrafiltrate that have moved into the abdominal cavity. The proposed direct sodium removal ("DSR") method removes tissue from the dialysate, similar to conventional peritoneal dialysis. Rather than trying to purify and remove toxins and accumulated metabolic by-products, It is fundamentally different from conventional peritoneal dialysis in that it is specifically designed to treat fluid overload. They are different.

[0014] According to one aspect of the present invention, the DSR method, injectable solution, and apparatus of the present invention are generally 15 mL / min / 1 0.73 m 2 A GFR value exceeding this should indicate renal function ranging from normal to CKD stage 4, and fluid overload. It is expected to be suitable for use in heart failure patients suffering from severe illness. This includes patients with stage 5 CKD or GFR <1. 5 ml / min / 1.73 m 2 In patients with this condition, the use of a sufficient amount of non- or low-sodium DSR infusion for dialysis is This can lead to dangerous or end-stage hyponatremia and a decrease in plasma volume that can result in circulatory collapse. It is likely that, in order to avoid hyponatremia in these patients who require dialysis, Using small amounts of non- or low-sodium DSR infusion solution can lead to insufficient removal of waste products, resulting in urine. It can cause toxicity. In other words, it is suitable for direct sodium removal using the method of the present invention. Patients who undergo this procedure are likely to be those who are not typically eligible for dialysis for the purpose of treating chronic kidney disease (CKD).

[0015] In particular, due to concerns regarding symptomatic hypotension, as well as hyponatremia and related effects. They are typically eligible for dialysis with end-stage renal failure and have stage 5 chronic kidney disease or 15 mL / min / 1.73 m³. 2 below Patients exhibiting a GFR are excluded from the patient population eligible for use in the DSR method of the present invention. It should.

[0016] The proposed method using a sodium-free or low-sodium DSR injection solution in accordance with the principles of the present invention is The entirety of the U.S. Patent Application Publication, which has been assigned to the assignee of this invention, is incorporated herein by use. This can be achieved with the planted pump system described in Application Publication No. 2014 / 0066841. The published application describes a system for portable peritoneal dialysis, and the system Then, the patient has dialysis fluid injected into their abdomen, and at predetermined intervals after a predetermined time, the implanted pump is large A certain amount of dialysis fluid can be transferred to the patient's bladder and then expelled through urination. According to the principle, the process is carried out without addressing CKD, or even basic countermeasures. Instead, this process uses a sodium-free or low-sodium DSR infusion solution to treat patients with residual renal function. This procedure is performed to remove sodium from heart failure patients suffering from fluid overload. As a result, (i) By urination (as a result of residual renal function) and (ii) by direct removal of osmotic ultrafiltrate Body fluids are removed from the body, preventing hyponatremia and restoring serum sodium levels. This reduces fluid overload and edema. [Brief explanation of the drawing]

[0017] (Brief explanation of the drawing) [Figure 1A] Figure 1A is a perspective view of an exemplary system for performing the method of the present invention on a heart failure patient with residual renal function who is suffering from fluid overload.

[0018] [Figure 1B] Figure 1B is a plan view of the selected components of the system shown in Figure 1A, as implanted in the patient.

[0019] [Figure 1C] Figure 1C is a plan view of selected components of an alternative embodiment of an exemplary system for carrying out the method of the present invention.

[0020] [Figure 1D] Figure 1D illustrates the steps of an exemplary method according to the principles of the present invention, using the systems shown in Figures 1A to 1C.

[0021] [Figure 2A] Figure 2A is a side view of an exemplary embodiment of a peritoneal catheter suitable for use in the system shown in Figure 1. [Figure 2B] Figure 2B is a detailed perspective view of an exemplary embodiment of a peritoneal catheter suitable for use in the system of Figure 1, and corresponds to detail area 2B of Figure 2A.

[0022] [Figure 3A] Figure 3A is a side view of a first embodiment of a bladder catheter suitable for use in the system shown in Figure 1. [Figure 3B] Figure 3B is a perspective view of a second embodiment of a bladder catheter suitable for use in the system shown in Figure 1.

[0023] [Figure 4] Figure 4 is a schematic diagram of the electronic components of an exemplary embodiment of the implantation device.

[0024] [Figure 5A] Figure 5A is a perspective view of the implantation device, with the housing outlined. [Figure 5B] Figure 5B is a front perspective view of the implantation device after the housing and the low-permeability filler have been removed.

[0025] [Figure 6A] Figure 6A is an assembled and disassembled perspective view of the drive assembly of the implantation device. [Figure 6B] Figure 6B is a front view of the upper housing of the planting device. [Figure 6C] Figure 6C is a plan view of the upper housing of the implantation device. [Figure 6D] Figure 6D is a perspective view of the manifold of an exemplary embodiment of the planting device.

[0026] [Figure 7A] Figure 7A is a perspective view of an exemplary handpiece portion of a charging and communication system used when carrying out the method of the present invention. [Figure 7B] Figure 7B is a top view of the handpiece portion of an exemplary charging and communication system used when carrying out the method of the present invention.

[0027] [Figure 8] Figure 8 is a schematic diagram of electronic components of an exemplary embodiment of a charging and communication system used when carrying out the method of the present invention.

[0028] [Figure 9] Figure 9 is a schematic diagram of the software used to implement the monitoring and control system when carrying out the method of the present invention.

[0029] [Figure 10] Figure 10 shows the main screen display as seen by the physician running the monitoring and control software.

[0030] [Figure 11] Figure 11 shows the screen display for selecting the "Smart Charger" submenu item in Figure 10.

[0031] [Figure 12] Figure 12 shows the screen display for selecting the "Download" menu item and the "Log File" submenu item in Figure 10.

[0032] [Figure 13] Figure 13 shows the screen display for selecting the "Pump Settings" menu item and the "Liquid Transport" submenu item in Figure 10.

[0033] [Figure 14] Figure 14 shows the screen display for selecting the "Test" menu item and the "Manual Commissioning" submenu item in Figure 11.

[0034] [Figure 15] Figures 15A, 15B, and 15C are graphs showing the results of testing the DSR method of the present invention on the initial group of five animals.

[0035] [Figure 16] Figures 16A to 16F are graphs showing the results of testing the DSR method of the present invention on a tracking group of 10 animals.

[0036] [Figure 17] Figures 17A to 17F are graphs showing the changes in blood volume, red blood cell count, and plasma volume of a second subgroup of animals after the continuous application of the DSR method of the present invention.

[0037] [Figure 18] Figure 18 is a graph showing the changes in serum sodium levels in a subgroup of animals in the second group after the continuous application of the DSR method. [Modes for carrying out the invention]

[0038] (Detailed description of the invention) This invention relates to fluid overload in various forms of heart failure, such as left ventricular dysfunction or right ventricular dysfunction. This invention relates to a method for treating residual renal function suffering from fluid overload, according to the principles of the present invention. Heart failure patients are treated with a non- or low-sodium DSR infusion administered intraperitoneally. If the sodium concentration of the infusion solution is low, sodium and body fluids (osmotic ultrafiltrate) may be absorbed into the patient's body. It then moves into the abdominal cavity. The DSR infusion fluid remains in the ventilated sodium for a specified period until it is removed. It can remain or be retained in the peritoneal cavity along with the osmotic ultrafiltrate. Removal of the contained DSR infusion solution and osmotic ultrafiltration solution from the peritoneal cavity is performed by Sequana Medical AG, Zurich. This can be done using planting systems such as Alfapump, which is sold by Switzerland.

[0039] As used in this disclosure, a sodium-free or low-sodium DSR injector is less than 120 meq / L. Preferably having a sodium content of less than 35 meq / L and a sodium concentration of substantially zero. It includes the ingestion fluid. Therefore, the method for treating excess body fluid of the present invention is applicable to patients with residual renal function and therefore renal failure. The use of the method of the present invention is particularly intended for patients with heart failure. Sea urchin, residual kidney function: 15 ml / min / 1.73 m 2 GFR values ​​exceeding a certain level, or from normal to stage 4 CKD. Suitable for patients with renal function.

[0040] An exemplary DSR injection solution formulation according to the principle of the present invention is a D-0.5 to D-50 solution, i.e., an aqueous solution. 0.5 to 50 grams of dextrose per 100 ml; 0.5 to 50 grams of echoes per 100 ml aqueous solution Icodextrinn solution containing dextrin; 0.5 to 50 grams of dextrin per 100 ml aqueous solution High molecular weight glucose polymer solution containing a large amount of glucose polymer (weight-average molecular weight Da> This includes 10,000), and combinations thereof. The aqueous solution contains at least purified water, and further , small amounts of magnesium or calcium salts, preservatives, antibacterial or antifungal properties It may contain electrolytes such as components, or buffering substances to adjust the pH of the infusion solution. String, high molecular weight glucose polymer, or other high molecular weight glucose polymer (weight per square meter) When used in a peritoneal dialysis environment, the uptake rate of homogeneous molecular weight (Da > 10,000) is observed to decrease. It was observed that, therefore, serum glucose concentration was lower compared to dextrose-based DSR solution. Because it can be used in this way, it is expected to be preferable to dextrose in some cases.

[0041] The sodium-free or low-sodium DSR injectors described herein may result in fatal consequences. Therefore, it should be used in all heart failure patients with fluid overload, especially those with little to no residual renal function. It is not expected that there will be any. For example, for heart failure patients with a GFR value of less than 15 or CKD stage 5. The method and use of the DSR infusion solution of the present invention may result in severe hyponatremia and hypotension. It is expected that this may occur. Therefore, for safety reasons, not only those suffering from heart failure, but also , renal failure, or 15 ml / min / 1.73m 2 Patients with the following GFR or stage 5 CKD are subject to the following: It is contraindicated to use this product in conjunction with the treatment methods described.

[0042] The method and DSR injection solution of the present invention are used in treating heart failure using conventional peritoneal injection and drainage techniques. It is thought that this invention can be used to treat fluid overload in the following cases, but the implementation of this invention is limited to the present application. This can be done particularly advantageously using the planting pump system provided by the transferee. It is expected that this will be the case. Specifically, it will be provided by Sequana Medical AG, Zurich, Switzerland. The Alfapump system is well-suited for treating heart failure using the peritoneal injection mode. According to one aspect of the present invention, a sodium-free or low-sodium DSR injectable solution is introduced into the peritoneal cavity, With zero or low sodium concentration, sodium and osmotic ultrafiltrate are absorbed by the patient. It moves from the body into the abdominal cavity. At predetermined intervals during a predetermined period after the injection of the DSR infusion, the clinician Operate the implantation pump according to the programmed instructions, and administer sodium-containing DSR injection. The infusion and osmotic ultrafiltrate can be pumped to the patient's bladder at a predetermined flow rate. The removal of sodium is (i) by the functioning kidneys via urination, and (ii) after Due to the direct accumulation of osmotic ultrafiltrate into the abdominal cavity, which is removed to the bladder via an implanted pump. This leads to the removal of body fluids. In this way, an appropriate and stable serum sodium concentration was maintained. Sodium and body fluids are removed. Furthermore, after the DSR session, the result of fluid overload and It is expected that bodily fluids will continue to accumulate in the abdominal cavity, and these fluids will be pumped to the bladder periodically. The implanted pump can be programmed to transport bodily fluids accumulating in the abdominal cavity. Since it is expected to contain sodium, the removal of such fluids into the bladder will This will further reduce fluid overload in these patients.

[0043] Therefore, the method of the present invention controls fluid overload and edema in heart failure patients, and also... Patients can live a more normal lifestyle, freed from frequent visits to hospitals or other medical facilities. The present invention provides a method that allows one to experience a reduction in body fluid volume. Advantageously, the present invention provides a method that allows one to experience a reduction in body fluid volume. This allows patients to experience improved comfort and lifestyle. Furthermore, it also prevents the progression of chronic kidney disease and co-existing conditions such as progressive heart failure.

[0044] An exemplary implantation system for carrying out the method of the present invention moves fluid from the abdominal cavity to the bladder. This includes a planting pump specially configured to perform the following, which is described in more detail below. Therefore, the implanted pump monitors and records operating parameters related to the patient's health. It is equipped with multiple sensors. The externally located charging and communication system is periodically charged. Communicate with the implantation device and download recorded operating parameters from the device. The monitoring and control software on the doctor's computer inside the building records information from the charging and communication system. The recorded operating parameters are received and reflected in the patient's health. Based on the physician's understanding of the matter, the physician may change the operation of the implantation device. The monitoring and control software may, at its discretion, detect infections based on recorded operating parameters. Prediction or detection of decompensated heart failure or other clinical events. It can be configured to warn doctors regarding this. The implantable device suppresses infection. The system may optionally also include one or more ultraviolet (UV) sources configured in this manner.

[0045] (Outline of an exemplary system for carrying out the method of the present invention) Referring to Figure 1A, an exemplary selection of system 10 for use in carrying out the method of the present invention is shown. An overview of the components is shown. In Figure 1A, the components of the system are shown both relatively and absolutely. The scale is not accurate. System 10 includes an implantation device 20, external charging and communication. System 30, software-based monitoring and control system 40, and optionally DSR note Includes an input fluid reservoir 45. In the illustrated embodiment, the monitoring and control system 40 is responsible for Traditional laptop computers, tablets, or smart computers that can be used by doctors. It is installed on the phone and runs on these. During the patient examination, it is kept in the implantable device 20. To download stored inspection data, or to adjust the operating parameters of the implantation device To achieve this, the charging and communication system 30 is connected to the monitoring and control system 40 wirelessly or via a wired connection. It can continue. The monitoring and control system 40 is recovered from the charging and communication system 30. The collected data is uploaded to a remote server that the doctor or the charging and communication system 30 will later access. It can also be configured to download and save.

[0046] The implantable device 20 is an electromechanical pump having a housing 21 configured for subcutaneous implantation. It is equipped with. As will be described in more detail below with reference to Figure 1C, the implantation device 20 is unsuitable. Electric motor-mechanical gear pump configured to reduce the risk of accidental separation due to careful installation and carelessness. , and can also be equipped with a second pump connector 22 and a first pump connector 24, and not It can be further equipped with a separate cross section to further reduce the risks of improper installation. The 46 and bladder catheter 25 are connected to the pump housing 21, and in some embodiments It can be connected to the pump housing 21 using the first pump connector 24. Peritoneal The catheter 23 is connected to the pump housing 21 and the second pump connector 22 is used to pump It can be connected to the pump housing 21. The DSR infusion fluid is delivered from the reservoir 45 to the patient's abdominal cavity. The peritoneal catheter 23 is supplied. The peritoneal catheter 23 is configured to be connected to the pump housing 21. A ch It is equipped with a tube. The bladder catheter 25 is configured to be connected to the pump housing 21. The first (proximal) end and the device are configured to be inserted through the patient's bladder wall and fixed inside the bladder. It comprises a tube having a second (distal) end. In a preferred embodiment, both ends The catheter is made of medical-grade silicone and is used to hold the catheter in place. Therefore, they are equipped with polyester cuffs (not shown) at their distal ends.

[0047] The optional reservoir 45 is used to deliver no or low sodium DSR to the patient's peritoneal cavity via catheter 46. The catheter 46 is configured to deliver the injectable fluid, and is described below with reference to Figures 2A and 2B. It may have a structure similar to that of a peritoneal catheter, which will be explained further below. See Figure 1B for further details. In this embodiment, the proximal end of the catheter 46 is connected to the external reservoir 45 by appropriate connection. It can be configured to connect detachably, and the patient can replace the empty reservoir with a new one. The catheter can be easily replaced with a servicing catheter, and the distal end of the catheter 46 is implanted into the patient's abdominal cavity. It can be configured for insertion, and a tissue cuff (not shown) can be inserted into the patient's skin and the catheter 46. / or promote tissue implantation at a position transverse the peritoneal wall. The distal end of catheter 46 is shown in Figure 2B. As discussed below with reference to the following, it may have multiple defined holes or openings. The -bar 45 is driven by gravity or any other suitable mechanism, or by the operation of an external pump (not shown). This allows the DSR injection fluid to be delivered into the peritoneal cavity. For example, using an external pump, The flow of DSR infusion fluid from the reservoir 45 into the peritoneal cavity may be facilitated, or the reservoir may be moved to the level of the peritoneal cavity. By physically lifting it upwards, gravity allows the DSR injection fluid to enter the abdominal cavity via catheter 46. You can draw people in.

[0048] In the embodiment shown in Figure 1C, instead, the distal end of the reservoir catheter 46' is located in the implantation device. Attached to the first pump connector 24 of the 20, the implantation device 20 has a reservoir for DSR injection solution From 45, the fluid is pumped into the abdominal cavity via the reservoir catheter 46' and the peritoneal catheter 23. It can be configured in such a way. In such an embodiment, the reservoir 45 is external or planted It can also be a tubular type, and the implantation device 20 pumps the fluid from the reservoir into the abdominal cavity at the same time, To prevent leakage of fluid from the reservoir to the bladder and pumping of fluid from the bladder to the abdominal cavity It may further include one or more passive or active valves. The passive or active valves are Furthermore, when the sodium-containing DSR infusion solution and osmotic filtration solution are pumped from the abdominal cavity to the bladder... At the same time, it is possible to prevent such fluid from being pumped from the abdominal cavity to the reservoir. In an alternative method, one or more passive or active valves can be used with a reservoir catheter 46', peritoneal catheter. The catheter 23 and / or the bladder catheter 25 may be placed inside the catheter.

[0049] Preferably, the implantation device 20 contains a sodium-containing DSR injection solution and an osmotic ultrafiltration solution. Selected to provide sufficient time for the target amount of sodium to accumulate in the DSR infusion. It is configured to move from the abdominal cavity to the bladder in a specified amount, interval, and flow rate, and as a result, the body The decrease in sodium within (i) is due to the functioning kidneys (through urination), and (ii) This results in the removal of body fluids by the direct removal of osmotic ultrafiltrate from the abdominal cavity into the bladder, thereby improving the heart Fluid overload and edema resulting from the deficiency are reduced. The treatment algorithm involves various formulations and quantities. DSR infusion solutions with no or low sodium content, varying retention periods, and varying bladder removal rates. It can be emitted. Generally, pump transport at short but frequent intervals is performed with catheters 23 and 25 It is expected to suppress the accumulation of material in the internal lumen and reduce the risk of tissue implantation. The liquid circuit of the implantation device 20 is configured to provide an average flow rate of approximately 1 to 2.5 liters / hour. This is possible, but much higher and lower flow rates are also possible as needed. As will be explained in detail, DSR injection is administered using the monitoring and control system 40 required for a specific patient. The physician will program the time, flow rate, and volume of pump transport, including the time the infusion can be maintained in the abdominal cavity. It can be rammed.

[0050] The implantation device 20 releases fluid if the pressure inside the abdominal cavity exceeds a limit determined by the physician. The pressure in either the abdominal cavity or the bladder is monitored to ensure that blood is pumped from the abdominal cavity to the bladder. It may be equipped with a pressure sensor. Alternatively, the output of the pressure sensor may be additional The fluid is pumped into the bladder until it is determined that the bladder has enough space to hold the fluid. It can be prevented from being transported. For the patient's comfort, the implantation device 10 is used at night. , or an accelerometer installed in the implanted device detects that the patient is asleep (and therefore, discharge from the bladder) When it is highly likely that it cannot be done, you can optionally avoid pumping. It can be programmed. The implantation device 20 preferably pumps urine into the bladder. It is equipped with multiple separate safety mechanisms to absolutely prevent it from flowing into the abdominal cavity, thereby preventing the transmission of infection. The risk of this happening is reduced.

[0051] Furthermore, referring to Figure 1A, an external charging and communication system of an exemplary system in a preferred form. The system 30 comprises a base 31 and a handpiece 32. In this embodiment, the handpiece 32 is , control device, wireless transceiver, inductive charging circuit, battery, charge quality indicator, and It is equipped with a display and is detachably mounted on the base 31 for charging the battery. The base 31 is configured to operate at a normal voltage of 120 V or 220 V when the handpiece 32 is mounted on the base 31. A converter and a rotary converter for converting 240 V power to an appropriate DC current to charge the handpiece 32. A circuit can be provided. In an alternative embodiment, the handpiece 32 may have such a circuit and It can be equipped with a detachable power cord, which allows the handpiece to be plugged directly into an outlet. It becomes possible to insert and charge the battery. In one preferred embodiment, the implantation device Each of the 20 and the handpiece 32 is equipped with a device identifier stored in memory, and for this reason, The handpiece 32 provided to the patient is designed to operate only with the patient's specific implantation device 20. It is encoded as follows.

[0052] The handpiece 32 preferably includes a multifunction button 34, a display 35, and multiple light-emitting diodes. It comprises a housing 33 having a light (LED, not shown) and an induction coil portion 36. The 34 allows the patient to issue a limited number of commands to the implantation device 20. Meanwhile, the display 35 provides a confirmation that the desired command has been entered; The display also shows the battery status. The induction coil section 36 is energy The induction is used to transmit power from the handpiece 32 to charge the battery of the implantation device 20. It houses the guide coil. When the LED is lit, it is visible through the material of the housing 33. It can be arranged in three rows with two LEDs in each row, and is housed within the handpiece 32. It is connected to a control circuit and an inductive charging circuit. The LED is lit during the recharging of the planting device 20. To reflect the degree of inductive coupling achieved between the endpiece 32 and the implantation device 20, points They can be arranged to light up. Alternatively, the LEDs can be omitted to show the quality of inductive coupling. The log display may be shown on display 35.

[0053] The control circuit housed within the handpiece 32 includes an inductive charging circuit, a battery, an LED, and wireless It is connected to a transceiver and has a memory for storing information from the implantation device 20. The handpiece 32 is also preferably used to monitor the handpiece when a patient visits the clinic. It also includes a data port, such as a USB port, that enables connection to the control system 40. Alternatively, the handpiece 32 may conform to, for example, Bluetooth or IEEE 802.11 wireless standards. It can be equipped with a wireless chip, which allows the handpiece and the monitoring and control system 40 to Wireless communication will be possible, either directly or via the Internet.

[0054] The monitoring and control system 40 is primarily intended for use by physicians, and also A modern computer, for example, a laptop or tablet as illustrated in Figure 1A This includes software configured to run on a smartphone. According to A, the physician sets and monitors the operation of the charging and communication system 30 and the implantation device 20. and can be controlled. The software can control the operation of the pump, for example, daily or motor The target amount of fluid to be transported per operation, the pump operation interval, and intra-abdominal pressure, bladder pressure, pump pressure, and The system may include routines for setting and controlling battery temperature limits. System 40 also, Avoid transporting fluids during certain periods (e.g., at night), or when the patient is sleeping. The charging and control system 30 issues a command to the planting device 20 to postpone the operation of the pump. The system 40 can, for example, immediately control the operation of the planting device 20. A command is sent to the planting device to start or stop the pump, or the pump or The pump is operated in reverse or at high power to remove obstructions in the associated catheter. It can be further configured to do so. The software of system 40 also controls the pump operation. Related real-time data and event logs saved during the operation of the implantation device 20 It can be configured to download, for example, based on the downloaded data. Based on measurements of the patient's intra-abdominal pressure, respiratory rate, and / or fluid accumulation, the system 40 The software is for decompensated heart failure, and / or flow rate, volume, time, and / or pump Regarding the prediction or detection of changes in the patient's health condition that may require adjustment of the frequency of the operation, consult with a physician. It can be optionally configured to issue a warning. Finally, system 40 provides a secure internet connection. Raw motion data or filtered data is transmitted from the patient's handpiece 32 through the ret channel. The system can be configured to remotely receive the recorded operation data.

[0055] Here, referring to Figures 1B to 1D, the implantation device 20 and the optional DSR injection solution reservoir 45 Various configurations are described here. Using the system 10 according to the present invention, those suffering from fluid overload... A method for treating patients with heart failure is provided with reference to Figure 1D.

[0056] Referring now to Figure 1B, an exemplary use of the implantation device 20 for carrying out the method of the present invention The device 20 is preferably located outside the patient's abdominal cavity 11, which is defined by the peritoneum 12. On the other hand, charging and communication can be easily performed by the charging and communication system 30 illustrated in Figure 1A. The device 20 is implanted subcutaneously beneath the skin 13. The device 20 is connected via an appropriate connector (not shown). It is then connected to the peritoneal catheter 23 and the bladder catheter 25. The peritoneal catheter 23 is connected to the patient's abdomen It is configured to be implanted in the cavity 11, and preferably, more details below refer to Figures 2A and 2B. It has an opening 53 that can be explained in detail. The bladder catheter 25 is implanted in the patient's bladder 13. It is configured as described below in more detail with reference to Figures 3A and 3B, preferably as described below. The bladder 13 is equipped with an anchor for fixing the outlet end of the catheter.

[0057] The optional DSR infusion reservoir 45 is placed outside the body and connected to the abdominal cavity via a catheter 46. The catheter 46 is configured to allow the patient to easily replace the reservoir 45 periodically. The catheter 46 is connected to the reservoir 45 via a connector 47. Preferably, the opening 53 It is equipped with an opening 53' which may be similar in dimensions and density, and the opening 53' allows the DSR injection fluid to enter the peritoneal cavity 11 This allows for relatively diffuse inflow. An optional external pump 48 is used to supply the DSR injection fluid. It can be configured to allow fluid to flow from the reservoir 45 into the abdominal cavity 11 at the desired speed. For example, The server 45 can be positioned on a belt (not shown) worn around the patient's waist, and It is equipped with a pump 48. The pump 48 is implanted to regulate the delivery of DSR infusion fluid into the patient's peritoneal cavity. It can be configured to communicate wirelessly with the integration device 20.

[0058] In an alternative embodiment, the DSR injector reservoir 45 is such that gravity causes the DSR injector to flow into the reservoir 45. Then, it is positioned above the level of the abdominal cavity 11 so that it flows into the peritoneum at the desired speed. In this embodiment, to deliver a predetermined flow rate without using a pump, a pressurized vessel is used, along with a control valve or This can be configured in combination with a calibration flow limiting device. In this way, the DSR injection fluid The delivery can be passive, requiring no electronic equipment or pumps. A predetermined amount of DSR The delivery of the infusion fluid is based on the increase in intraperitoneal pressure, the use of a flow meter, or other appropriate measurement system. It can be recognized by the planting device.

[0059] In the embodiments discussed above, the reservoir 45 preferably deals with fluid overload in heart failure patients. Alternatively, to alleviate the urge to irritate the peritoneal cavity, use a DSR infusion in an appropriate volume, rate, and frequency suitable for adequately filling the peritoneal cavity with DSR fluid. The injection fluid is supplied to the abdominal cavity 11.

[0060] Alternatively, as illustrated in Figure 1C, an optional DSR injection reservoir 45 can be used, for example, a bell It can be placed outside the patient's body using a harness or other means, and the catheter 46' and connector It can be connected to the implantation device 20 via the 47. The implantation device 20 receives the DSR injection solution. The natotransferase is pumped from reservoir 45 to the abdominal cavity 11 via catheters 46' and 23, and then subsequently... The DSR infusion solution containing lium and the osmotic ultrafiltration solution are delivered from the abdominal cavity 11 via catheters 23 and 25. It is configured to pump to the bladder 13. Specifically, the first port of the implantation device 20 The pump connector 24 is connected to the first valve 49' to which the catheter 25 is connected, and the catheter 46' is connected to the first valve 49' to which the catheter 46' is connected. It is equipped with a second valve 49. The second pump connector 22 of the implantation device 20 is connected to the catheter 23. Direct connection. During pump operation, the implantation device 20 allows fluid to flow from the bladder to the abdominal cavity, or from the abdominal cavity. Valves 49 and 49' are controlled to prevent accidental pumping into the reservoir. For example, to pump fluid from the reservoir 45 to the peritoneal cavity 11, the implantation device 20 is appropriate By activating valve 49', fluid communication with catheter 25 can be blocked, and the valve To establish fluid communication between catheter 46' and 23 by properly operating 49. This allows for the pumping of liquid from the reservoir 45 through the catheters 46' and 23. It can then be turned in the first direction. Alternatively, the reservoir 45 is implanted in the patient's body. It can be connected to the external environment using a catheter so that reservoir 45 can be refilled. Cut.

[0061] After the DSR injection fluid has remained in the peritoneal cavity for a predetermined time, the implantation device 20 will properly activate the valve 49. By doing so, communication to catheter 46' is blocked, and valve 49' is properly activated. This establishes communication with catheter 25, and the fluid is then delivered to the patient's bladder via catheters 23 and 25. By changing direction to a second direction (opposite to the first direction) to pump the contents to the bladder 13, The DSR injection solution and osmotic ultrafiltration solution can then be pumped to the bladder 13. Valve 49 and The functions of 49' are appropriately positioned along catheters 23, 25, and 46', and for example, as shown in Figure 4. The valve control device 86 illustrated in the example is operated controllably by the implantation device 20. It can be provided by the desired number of valves. In a particular configuration, one or more passive The use of a valve (not controlled by the implantation device 20) may be appropriate, for example, valve 49' is A passive check valve positioned along the catheter 25 prevents the flow of fluid from the bladder to the device 20. It could be a valve.

[0062] A method using an exemplary planting system as illustrated in Figures 1A to 1C is shown in Figure 1D. This will be explained here. Method 1000 involves transferring fluid from a reservoir located inside or outside the patient's body to the abdominal cavity. This includes introducing a sodium-free or low-sodium DSR infusion solution (step 1010). For example, Figure 1B As mentioned above, the DSR injection fluid is introduced using an external pump or gravity. This can be done. Alternatively, as described above with reference to Figure 1C, the DSR injection solution is used in the implantation device 20, and It can be introduced using one or more valves connected to the planting device 20. A certain amount of DSR infusion solution is introduced into the patient's abdominal cavity and allowed to remain there, thereby removing sodium from the patient's body. The fluid can be removed into the cavity, and the osmotic ultrafiltrate can be accumulated in the abdominal cavity, and the osmotic ultrafiltrate can be removed from the abdominal cavity. The ultrafiltrate is removed into the bladder.

[0063] Sodium moves from the patient's body through the peritoneum to the abdominal cavity, and from the abdominal cavity to the bladder. This lowers sodium levels in the body, resulting in (i) functioning through urination (ii) the removal of body fluids by the kidneys, and (ii) the removal of osmotic ultrafiltration fluid accumulating in the abdominal cavity into the bladder. This leads to the removal of the substance, restoration of serum sodium concentration, and a decrease in the patient's body fluid volume (step). (P1020). DSR injectable solution and osmotic ultrafiltration solution containing sodium are administered to the peritoneal cavity via the implantation device. Then it is pumped into the bladder (step 1030). Such pumping transport is performed as described above. Sufficient time to draw out enough sodium from the body to alleviate fluid overload. This can be done after the DSR infusion fluid has entered the peritoneal cavity. Then, the patient's kidneys will also excrete The body can excrete fluid through urine, which restores serum sodium concentration (STE) (1040).

[0064] Using the charging and communication system described above, with reference to Figure 1A, energy is implanted. It can transmit data wirelessly to a device and receive data from that device. Step 1050). For example, the implanted device has parameters that reflect the patient's health and the operation of the device. It can record data and transmit those parameters to the charging and communication system. Next, data such as parameters recorded by the implantation device are monitored and controlled. The software is provided to the monitoring and control system, and the monitoring and control software communicates with the charging and communication system. and under the control of the physician during the procedure (step 1060). Based on those parameters, The software can be used to assess the patient's health condition, and the doctor can take the removed n Before removing the DSR injection solution and osmotic ultrafiltration solution containing thorium into the bladder, the implantation device Remotely communicate any changes to the flow rate, volume, duration, or frequency of the DSR infusion delivered to the peritoneal cavity. (Step 1070) Such communication can be transmitted via the charging and communication system. It is possible to do so.

[0065] Here, selected configurations of the exemplary system shown in Figures 1A to 1C for carrying out the method of the present invention Further details of the constituent elements are provided with reference to Figures 2A to 8.

[0066] (Peritoneal catheter and bladder catheter) Referring to Figures 2A and 2B, the peritoneal catheter 50 is manufactured by Medionics International Inc. A membrane dialysis catheter (model number PSNA-100) or a catheter with a similar structure and function. It is possible. The peritoneal catheter 50 corresponds to the peritoneal catheter 23 in Figures 1A to 1C, and has multiple wall-penetrating holes. It is made of medical silicone and has an inlet (distal) end 52 and an outlet (proximal) end 54 having 53. The tube 51 may be provided. The hole 53 is circular by about 90 degrees, as shown in Figure 2B. It can be positioned offset in the circumferential direction. The peritoneal catheter 50 is positioned around the catheter To promote adhesion to the surrounding tissue and thereby secure the catheter in place, hole 53 A polyester cuff (not shown) can also be provided in a part away from the peritoneal cuff. Alternatively, a peritoneal cuff can be provided. The entrance end 52 of the tetel 50 may have a helical structure and a non-traumatic tip, and the hole 53 is It is distributed along the entire length of the tube to reduce the risk of blockage.

[0067] The inlet end 52 also facilitates the catheter's attachment to the nearby tissue wall, thereby allowing the catheter to adhere to the tissue wall. A polyester cuff is provided to ensure that the entrance end of the tail is securely held in place. Yes, it is possible. The exit end 54 also secures the exit end of the peritoneal catheter to the implantation device 20. It can be equipped with a connector. In one preferred embodiment, the distal end of the peritoneal catheter It can pass through a standard 16F peel-away sheath to the implanted cuff. It can be configured in such a way. Furthermore, the length of the peritoneal catheter is along the bottom of the body cavity. It can be selected to ensure extension, and the peritoneal catheter can be implanted or implanted. It must be able to withstand twisting motions sufficiently so that it does not twist or bend after being fitted.

[0068] Referring to Figure 3A, the first bladder catheter 60 corresponds to the bladder catheter 25 in Figures 1A to 1C. An embodiment is shown. The bladder catheter 60 preferably has an inlet (proximal) end 62 and A tube 61 made of medical silicone having an outlet (distal) end 63 including a spiral structure 64, The bladder catheter 60 is equipped with a polyester implanted cuff 65. The bladder catheter 60 has a spiral structure 64 extending from the inlet end 62. A single internal lumen extending to a single outlet at the tip, commonly known as a "pigtail" design. The inlet end 62 is for fixing the inlet end of the bladder catheter to the implantation device 20. It may be equipped with a connector, or it may have a length that can be cut to suit a particular patient. Good. In one embodiment, the bladder catheter 60 may have a length L3 of about 45 cm. F65 is positioned at a length L4 of approximately 5-6 cm from the spiral structure 64. The bladder catheter 60 is The spiral structure 64 is straightened and attached to the stylet, and the outlet end 63 is used with the stylet. Furthermore, the spiral structure 64 can be implanted using a minimally invasive technique that allows it to pass through the patient's bladder wall. When the stylet is removed, the helical structure 64 returns to the coil shape shown in Figure 3A. Once the outlet end 63 of the bladder catheter 60 is positioned in the patient's bladder, the inlet end 62 of the catheter The rest of the catheter is connected to the implantation device 20 using tunneling technology. The helical structure 64 is implanted when the surrounding tissue of the bladder has healed sufficiently and the implanted cuff 65 has been taken up. Therefore, before the bladder catheter is fixed in place, the outlet end 63 is removed from the bladder. This reduces the risk of accidentally dropping something.

[0069] In one preferred embodiment, the bladder catheter 60 passes through a conventional peel-away sheath. It is configured to allow this. The bladder catheter 60 is preferably implanted or implanted It is designed to withstand torsional motion sufficiently so that it does not twist or bend later. In one preferred embodiment, The peritoneal catheter 50 and the bladder catheter 60 were accidentally swapped during connection to the implantation device 20. To avoid this, preferably they are different colors and have different shapes (e.g., square and round). or have different connection characteristics. Optionally, the bladder catheter 60 may be a bladder catheter Even if the planting device 20 is accidentally disconnected from the pump connector, and / or the planting device The pump of the injection device 20 draws the DSR infusion fluid from the reservoir 45 into the patient's abdominal cavity. Even if activated, the inlet end of the catheter is designed to absolutely prevent urine from flowing from the bladder into the abdominal cavity. An internal duckbill valve may be provided, positioned between section 62 and outlet end 63.

[0070] In an alternative embodiment, the peritoneal catheter and bladder catheter device prevent infection between body cavities. To control the spread, one or more anti-infective drugs may be included. Examples of anti-infective drugs that can be used include, for example, bacteriostatic substances, bactericidal substances, and one or more antibiotics. Antibiotic dispensers, antibiotic eluents, and substances that prevent bacterial adhesion. Coatings and combinations thereof can be cited. Furthermore, the implantation device 20 As will be further explained below with reference to Figures 4 and 5B, all possible pathogens are killed. To eliminate and thus suppress the development of infection, the fluid in the peritoneum and / or bladder catheter It can be equipped with a UV lamp configured to emit light.

[0071] Alternatively, instead of using separate catheters, a peritoneal catheter 50 and a bladder catheter are used. 60 can share a common wall, this means that the bladder and abdominal cavity share a common wall, and by this This may be convenient as it facilitates the insertion of a single dual-lumen tube. Furthermore, the peritoneum One or both of the catheter or bladder catheter along part of its length or its entire length You can reinforce it with ribbon or braided wire, or with a wire of a certain length Alternatively, the ribbon may be embedded inside the catheter or integrated into its surface for reinforcement. This is also fine. The braid or wire may be made of metal such as stainless steel, a superelastic metal such as nitinol, It can be manufactured from various suitable polymers. Such reinforcement is optional. It can also be used with the catheter 46 connected to the hub 45.

[0072] Referring to Figure 3B, a second embodiment of the bladder catheter is depicted, with similar components. In this case, the same reference number is enclosed in single quotes. Bladder catheter 60' is Preferably, the medical device has an inlet end 62', an outlet end 63', and a polyester implanted cuff 65'. It comprises a tube 61' made of therapeutic silicone. According to this embodiment, the outlet end 63' is It is equipped with a malecot structure 66, and the malecot structure is the exit of the catheter To reduce the risk of the end portion 63' of the catheter becoming dislodged due to carelessness after placement, the catheter It exemplifies four elastic wings 67 that extend laterally away from the axis. Inlet end 62' The device may also include a connector for securing the inlet end of the bladder catheter to the implantation device 20. It may have a length that can be cut to suit a particular patient.

[0073] The Marco structure 66 preferably has a stylet inserted through the lumen of the catheter. The wing 67 is configured to deform into a substantially flat structure when it is moved. Then, a 60' bladder catheter can be attached to the stylet, using minimally invasive technology. The outlet end 63' and the Marco structure 66 are used to pass through the patient's bladder wall. This is possible. When the stylet is removed, the wing 67 of the Marco structure is shown in Figure 3B. It returns to its expanded shape. The outlet end 63' of the bladder catheter 60' is connected to the patient's bladder. When inserted, the remaining portion of the catheter inserts the catheter's inlet end 62' into the implantation device 20. It is implanted using tunneling technology so that it can be connected. The Marco structure 66 is located around the bladder. Before the tissue has fully healed and the implanted cuff 65' has been taken in, the outlet end 63' is inadvertently removed from the bladder. The risk of slipping out can be reduced. Similar to the embodiment in Figure 3A, the bladder in Figure 3B Tetel can be configured to pass through a conventional peel-away sheath, which is preferable. Furthermore, to prevent twisting or torsion during or after planting, the plant should be able to withstand twisting motion sufficiently. ru.

[0074] (Implantation device) Referring now to Figure 4, the planting device 20 suitable for use in carrying out the method of the present invention is A schematic diagram representing the functional blocks is shown. The implantation device 20 includes a non-volatile memory 71, for example. For example, flash memory or electrically erasable / writable read-only memory, and volatile memory A control circuit, exemplified by a processor 70, is connected to the Mori 72 by a data bus. The Sessa 70 consists of an electric motor 73, a battery 74, an induction circuit 75, a wireless transceiver 76, a UV lamp 85, and a parallel In addition, there is a humidity sensor 77, multiple temperature sensors 78, an accelerometer 79, multiple pressure sensors 80, and a respiratory rate sensor. It is electrically connected to multiple sensors, including sensor 81. The induction circuit 75 is used for charging and communication. While the coil 84 is electrically connected to receive the energy transmitted from the stem 30, The transceiver 76 is connected to the antenna 82, and similarly, the charging and It is configured to communicate with the transceiver of the communication system 30. Optionally, the inductive circuit 75 also It can be connected to an infrared light-emitting diode 83. The motor 73 is equipped with a dedicated control device. The control device can understand commands from the processor 70 and respond to those commands. The motor 73 is then activated. Optionally, the processor 70 communicates further with the valve control device 86. All the components shown in Figure 4 are small, sealed, biocompatible, as shown in Figure 5A. It is housed within a compatible housing.

[0075] The processor 70 receives signals generated by the motor 73, sensors 77-81, and the transceiver 76. The operation of the motor 73 is controlled in response to the commands received, and is stored in the non-volatile memory 71. The processor 70 also executes the firmware. It controls the operation of the induction circuit 75 for transmitting and receiving and charging the battery 74. Furthermore, the processor The 70 receives a signal generated by a Hall effect sensor installed inside the motor 73. The signal indicates the direction and rotation of the gears of the gear pump, and therefore the pump's transport, as described below. It is used to calculate the amount of liquid to be used and the viscosity of the liquid. Processor 70 is preferred The processor has a low-power mode of operation and is equipped with an internal clock, thereby It is activated periodically to perform pump transport, pump tick mode, or communication. And the charging function can be controlled and / or activated when the transceiver 76 receives a hand It can process commands from piece 32. In one embodiment, the processor 70 Te Micro The control unit includes the non-volatile memory, volatile memory, and wireless shown in Figure 4. It may include components of the transceiver. Furthermore, the firmware running on the processor 70 is To respond directly to commands sent to the implantation device 20 via the charging and communication system 30. It can be configured as follows. The processor 70 also includes the motor 72 (and The operation of all related motor control devices and sensors 77-81 are monitored, and an event log is logged. It is configured to store data that reflects the operation of the implantation device, including alarms. Therefore, when the charging and communication system is next wirelessly connected to the planting device, data The data is reported to the charging and communication system. In one preferred embodiment, the processor 70, Before the pump was activated, there were up to 80 log entries per second, indicating the planting system was active. When pumping, there are approximately 8 log entries per second, and when pumping is not being done... It generates approximately one log entry per hour.

[0076] The non-volatile memory 71 preferably includes flash memory or EEPROM and is embedded A unique device identifier for device 20, firmware running on processor 70, and the movement of the implantation device. Configuration setting data related to the operation, and optional transceiver 76 and / or induction circuit 75 and Saves the coding that runs in a separate motor control unit (if one exists). Non-volatile. Firmware and setting data stored in memory 71 are transmitted via the charging and communication system 30. It can be updated using new instructions supplied by the control and monitoring system 40. The volatile memory 72 is connected to the processor 70 and assists the operation of the processor 70, and The system stores data and event log information collected during the operation of the planting device 20. Mori 72 also transmits information to the charging and communication system 30 and the charging and communication system It also functions as a buffer for incoming information.

[0077] The transceiver 76 preferably includes a radio frequency transceiver and a charging and communication system 30 A similar transmitting and receiving circuit is located within the handpiece 32, and bidirectional communication is transmitted via the antenna 76. It is configured to be reliable. The transceiver 76 can also have a low-power operating mode. This allows it to be activated periodically, receive arrival messages, and assign them to the planting device. It responds only to messages containing a unique device identifier. Alternatively, the transceiver 76 may respond to related messages. The charging and communication system 30 simply communicates with the corresponding transceiver in the handpiece 32. Therefore, the transceiver 76 transmits data only when the induction circuit 75 of the planting device is operating. It can be configured to transmit or receive. Furthermore, the transceiver 76 can be connected to the planting device or Messages transmitted or received by the implanted device are absolutely not intercepted or forged. Encryption routines can be used to prevent this from happening.

[0078] The induction circuit 75 is connected to the coil 84 and is located inside the handpiece 32 of the charging and communication system 30. When exposed to the magnetic field generated by the corresponding inductive circuit of the implantation device, the battery 74 is configured to recharge. In one embodiment, the induction circuit 75 is configured It is connected to an optional infrared LED 83 that emits an infrared signal when in operation. The line signal is received by the handpiece 32 of the charging and communication system 30, and the handpiece implants It assists in alignment with the implantation device, thereby providing electromagnetic coupling to the implantation device and Energy transfer is improved.

[0079] The induction circuit 75 not only recharges the battery 74, but also removes obstacles to the pump. In "Boost" mode or Jog / Vibration mode, energy is directly supplied to motor 73. It can be configured as such. In particular, the motor 73 can, for example, provide intraperitoneal fibrin or When the processor 70 detects that it has stopped due to an obstacle formed by other debris, The alarm can be saved in memory. The implantation device 20 then communicates with the charging and communication system 30. When the alarm sounds, it is sent to the handpiece 32, and the patient presses the multifunction button 34. The option is to release the pump blockage by sending the overvoltage from the induction circuit 75 to the motor 73 over a certain period of time. It can be given. Alternatively, when the multifunction button is pressed, the processor 70 will issue a series of commands. This is performed so that, for example, the motor 73 rotates alternately in the reverse and forward directions. Then the motor jogs or vibrates to release the blockage. This operating mode is normal. Because it may consume more energy than expected during its operation, during such a procedure It is advantageous to drive the motor with energy supplied via the induction circuit 75.

[0080] The battery 74 is preferably designed to last a long time when implanted in the human body, for example, up to 3 Includes a lithium-ion battery or lithium polymer battery that can operate for a year, and This minimizes the need for re-operation to replace the implantation device 20. The battery 74 has a nominal voltage of 3.6V, a capacitance of 150mAh when new, and a lifespan of 2 years. It has a capacitance of approximately 120 mAh after use. Preferably, the battery 74 is used for pumping. 280 mA at normal times; 25 mA when the transceiver is charging and communicating with the communication system 30; Processor 7 0 and related circuits are operating, but when there is no pump transport or communication, the current is 8 mA; and plant When the feed device is in low-power mode, it is configured to supply a current of 0.3 mA to the motor 73. There is. More preferably, the battery 74 has a 450 mA charge for at least 10 seconds between each charging cycle. The capacity should be such that it allows for a minimum current of 1 A during h and 25 milliseconds.

[0081] The motor 73 preferably has a set of floats that operate as a gear pump, as described below. A brushless DC motor or electronically rectified motor having a spline output shaft that drives a drive gear. Yes. Motor 73 has a dedicated motor separate from processor 70 for controlling the operation of the motor. A control device may be provided. The motor 73 determines the position and rotation direction of the motor. It may be equipped with multiple, preferably two or more, Hall effect sensors. Processor 70 Due to the high humidity that the planting device 20 may encounter, even if all or one of the Hall effect sensors are affected, Even if the unit malfunctions, the program is designed to operate the motor 73, although the accuracy will be reduced. It is possible to obtain it.

[0082] In one preferred embodiment, the motor 73 drives the gear pump to a nominal flow rate of 150 ml / min Supply to apply a torque of about 1 mNm to a pressure head of 30 cm of water at 3000 RPM . In this embodiment, the motor is preferably selected to drive the gear at 1000 - 50 00 RPM corresponding to a flow rate of 50 - 260 ml / min. The motor is preferably non-solid proteinaceous To grind substances, it has a stall torque of at least 3 mNm, more preferably 6 mNm, at 500 mA, 3 V . As discussed above, the motor also preferably aids in boost mode operation at 5 V, for example, when directly powered by the induction circuit 75 . The motor 7 3 can also preferably be driven in reverse as part of a jog or vibration procedure to remove obstructions in the gear pump .

[0083] The processor 70 can be programmed to automatically and periodically activate and enter the pump tick mode . In this mode of operation, the gear pump rotates slightly, for example, about 120 degrees in the forward direction, measured by the hall effect sensor, before the processor 70 returns to the low output mode . Preferably, this interval is about every 20 minutes, but can be adjusted by the physician using the monitoring and control system . This pump tick mode is expected to prevent the DSR infusion and osmotic ultrafiltration fluids from partially coagulating and blocking the gear pump .

[0084] Furthermore, the processor 70 can also be programmed to enter the jog or vibration mode when operating on battery output to remove obstructions in the gear pump . Similar to the available boost mode when charging the implant device using the handpiece of the charging and communication system 30 , in the jog or vibration mode, the motor rotates the gear in the forward and reverse directions ​​ They move rapidly in alternating directions, and in other parts of the gear pump or fluid flow path, they combine To crush or loosen any accumulation of weave or residue. In particular, in this mode of operation, energy If the motor does not start within a certain period (e.g., 1 second) after the power is supplied, the motion will be The motor is rotated in the desired direction by briefly reversing its direction and then reversing it again. (Example) If the motor still does not rotate (due to the gear pump jamming), rotate the direction of rotation for a certain period of time. For example, reverse it again (for another 10 milliseconds). If the motor still cannot rotate in the forward direction... In combination, the time interval between reversals of the motor's direction is shortened, allowing the motor to generate higher output. This allows the gears to oscillate. The motor runs in the forward direction for more than 4 seconds. If it does not rotate in the direction, the jog mode operation will stop and an alarm will be written to the event log. It is loaded. If the motor cannot rotate in the forward direction, the processor 70 will then plan the next step. A reverse tick is introduced before the liquid transport. The reverse tick is a tick (for example, a mo It is the same as the forward motion of the axis (approximately 120 degrees), but in the reverse direction, and before rotating in the forward direction, This attempts to force the motor to rotate in the opposite direction, thereby generating thrust. It should be possible.

[0085] Sensors 77-81 continuously monitor humidity, temperature, acceleration, pressure, and respiratory rate, and respond accordingly. The signal is stored in memory 71 for later transmission to the monitoring and control system 40, along with the corresponding data. It supplies power to the processor 70. In particular, the humidity sensor 77 is expected to be a component of the planting device. To ensure reliable operation within the specified operating limits, the humidity inside the housing of the planting device is controlled. It is positioned to measure humidity. The humidity sensor 77 preferably measures humidity in the range of 20% to 100%. It can detect and report with high accuracy. One or more temperature sensors 78 are located inside the housing. The planting device, in particular the battery 74, is installed to ensure that the temperature of the battery does not overheat while charging. It can be monitored to prevent this from happening, and one or more other temperature sensors 78 can be placed at the entrance 62. It is arranged to come into contact with a liquid and is therefore used, for example, to assess the health status of a patient. The temperature of the liquid can be monitored. An accelerometer 79 is placed so that, for example, when a patient is sleeping. To determine whether or not, or to determine whether or not the patient is active and when the patient will be active. To do this, preferably measure the acceleration of the implantation device along at least two axes and activate it. The duration and inactivity period are detected. This information is used to determine when the pump stops functioning when the patient does not want to urinate. The pair is supplied to processor 70 so that it does not operate.

[0086] The implantation device 20 preferably has multiple sensors that are continuously monitored during the operating period of the processor. The planting apparatus of the present invention is equipped with a pressure sensor 80. As described below with reference to Figure 6A, the planting apparatus of the present invention Preferably, four pressure sensors: a sensor for measuring intraperitoneal pressure, and a sensor for measuring ambient pressure. Sensors for determining, sensors for measuring the pressure at the outlet of the gear pump, and pressure inside the bladder It is equipped with sensors for measuring force. These sensors are preferably less than 50 mW at 3 V. It is configured to measure absolute pressure from 450 mBar to 1300 mBar (45 kPa to 130 kPa) based on power consumption. Preferably, the sensors that measure the pressure at the pump outlet and inside the bladder contain urine and / or Duckbill prevents backflow of used DSR injection fluid and / or osmotic ultrafiltration fluid into the gear pump. It is arranged before and after the valve, and further enables flow rate calculation based on the pressure drop before and after the duckbill valve. Enable it.

[0087] The respiratory rate monitor 81 is configured to measure, for example, the respiratory rate of the patient used for evaluating the health state of the patient. Alternatively, the respiratory rate of the patient can be measured based on the output of one or more pressure sensors 80, for example, based on a change in ambient pressure or a change in the pressure within the abdominal cavity caused by the diaphragm that periodically compresses the abdominal cavity during respiration. Output based on, for example, changes in ambient pressure, or changes in the pressure within the abdominal cavity caused by the diaphragm that periodically compresses the abdominal cavity during respiration. It can be measured based on the change in the pressure within the abdominal cavity caused by the diaphragm that periodically compresses the abdominal cavity during respiration.

[0088] Any desired number of additional sensors for measuring the health state of the patient can also be provided to be operably communicable with the processor 70, output parameters that can be recorded for storage in the memory 71 and transmission to the monitoring and control system 40, which can be used by a physician to evaluate the health state of the patient. For example, a chemical sensor or a biochemical sensor configured to monitor the composition and / or sodium concentration of the DSR infusion solution containing sodium and the ultrafiltrate can be provided. Output parameters that can be recorded for storage in the memory 71 and transmission to the monitoring and control system 40, which can be used by a physician to evaluate the health state of the patient. For example, a chemical sensor or a biochemical sensor configured to monitor the composition and / or sodium concentration of the DSR infusion solution containing sodium and the ultrafiltrate can be provided. Output parameters that can be recorded for storage in the memory 71 and transmission to the monitoring and control system 4, which can be used by a physician to evaluate the health state of the patient. For example, a chemical sensor or a biochemical sensor configured to monitor the composition and / or sodium concentration of the DSR infusion solution containing sodium and the ultrafiltrate can be provided. Output parameters that can be recorded for storage in the memory 71 and transmission to the monitoring and control system 40, which can be used by a physician to evaluate the health state of the patient. For example, a chemical sensor or a biochemical sensor configured to monitor the composition and / or sodium concentration of the DSR infusion solution containing sodium and the ultrafiltrate can be provided. Output parameters that can be recorded for storage in the memory 71 and transmission to the monitoring and control system 40, which can be used by a physician to evaluate the health state of the patient. For example, a chemical sensor or a biochemical sensor configured to monitor the composition and / or sodium concentration of the DSR infusion solution containing sodium and the ultrafiltrate can be provided. Output parameters that can be recorded for storage in the memory 71 and transmission to the monitoring and control system 40, which can be used by a physician to evaluate the health state of the patient. For example, a chemical sensor or a biochemical sensor configured to monitor the composition and / or sodium concentration of the DSR infusion solution containing sodium and the ultrafiltrate can be provided.

[0089] The processor 70 is preferably programmed to pump a predetermined amount of liquid from the abdominal cavity to the bladder at a predetermined frequency after the liquid has been present in the abdominal cavity for a predetermined time. Such amount, Time, and frequency are preferably selected to optimize sodium removal to maintain or improve the health of the patient and reduce fluid overload. The amount, time, and frequency can be selected based on the patient's symptoms, Patient's activities and habits, the permeability of the peritoneum, and the osmotic characteristics of the DSR infusion solution. Time, and frequency are preferably selected to optimize sodium removal to maintain or improve the health of the patient and reduce fluid overload. The amount, time, and frequency can be selected based on the patient's symptoms, Patient's activities and habits, the permeability of the peritoneum, and the osmotic characteristics of the DSR infusion solution. It can be selected based on, for example, the physician's knowledge of the patient's health state and habits. The processor 70 can be programmed first in terms of initial time, quantity, and frequency, and later... Adjust the initial programming to change the amount, time, and / or frequency depending on the patient's health condition. Based on the physician's understanding of the condition, it is measured and monitored, for example, by the implanted device 20. and based on the changes over time of parameters communicated to the physician via the control software 40. It can be changed.

[0090] The processor 70 also monitors sensors 77-81 to detect any potential decline in the patient's health status. It can be programmed to generate warning conditions that are communicated to the medical doctor. For example, The Sessa 70 monitors the pressure sensor 80 and detects an increase in intraperitoneal pressure at predetermined time intervals. It is possible to determine whether or not such a pressure increase occurs. This could be a consequence of the increase, which could then lead to decompensated heart failure. Such warnings, This could lead to prompt treatment and guide the patient to prevent such decompensated heart failure. ru.

[0091] In other embodiments, the processor 70 controls the intra-abdominal pressure to prevent the bladder from becoming full. Only when the pressure in the bladder exceeds a predetermined value 1 and is less than a predetermined value 2, does the liquid enter the abdominal cavity. It can be programmed to pump fluid into the bladder. From the patient's sea level to a high altitude. To account for movement to altitude, ambient pressure measurements are used to calculate the differential peritoneal pressure. This method allows for a setting that takes into account lower atmospheric pressure when the pump starts. The pressure can be reduced. Similarly, ambient pressure can be used to adjust the bladder pressure to a predetermined value. This method allows patients to experience discomfort in their bladder at lower pressures when they are at high altitudes. Because this can be detected, the threshold pressure at which pump transport is stopped can be lowered.

[0092] Furthermore, the processor 70 determines that the DSR infusion fluid is pumped from the reservoir into the patient's abdominal cavity. Then, after the predetermined dwell time or the dwell time set by the patient has expired, sodium-containing DSR The time elapsed from the time the infusion solution and osmotic ultrafiltration solution are pumped from the abdominal cavity to the patient's bladder. It can be programmed to include a timer to monitor. Ramming also measures parameters such as excessive intraperitoneal pressure, which are measured by sensors 77-81. The trigger is the transfer of the contents of the abdominal cavity to the bladder before the specified retention period expires. It can be equipped with an override function to enable this.

[0093] Optionally, the control device 70 communicates with the UV lamp 85 in an operable manner, and the UV lamp 85 detects when liquid enters the peritoneal cavity. Irradiate the pathogens in the DSR infusion both before and after it is supplied to or removed from the peritoneal cavity. It is configured to kill them. The UV lamp 85 preferably has a UV-C spectral range It generates light in the range of approximately 200-280 nm, particularly in the range of approximately 250-265 nm, and this light has a spectrum The light in this range destroys nucleic acids in the DNA of microorganisms, hence it is also called the "bactericidal spectrum." Low pressure Mercury lamps have an emission peak at approximately 253.7 nm and can be used appropriately as UV lamps 85. Alternatively, the UV lamp 85 may be a UV light-emitting diode (L) based on AlGaAs or GaN. It could be ED.

[0094] Under the control of the control device 70, the UV lamp 85 is present in any liquid passing through the planting device. The liquid is irradiated for a pre-selected time sufficient to kill any potential pathogens. Specifically, the flow rate of the liquid passing through the device is sufficient to inhibit the growth of pathogen colonies. It is possible to select (for example, pre-program) to irradiate the liquid with a dose of UV light. For example, approximately 5,500 to 7,000 μWs / cm² 2 The dose of 253.7 nm UV light is used to kill E. coli. Proteus spp., Klebsiella spp., Serratia genus (Ratia spp.), Leptospirosis spp., Staphylococcus hemolymph Many organisms, including Staphylococcus haemolyticus and Enterococci, In contrast, it is known to be sufficient to provide a 100% lethality rate. Klebsiella genus (K Liebsiella ssp.), Enterobacter spp., Pseudomonas genus (Ps 100% effective against other organisms, including *Eudomonas spp.* and *Neisseria gonorrhoeae*. To achieve a lethality rate, a higher dose is required, for example, approximately 8,500–12,000 μWs / cm². 2 Required It is possible. However, the dose required to sufficiently inhibit colony growth is higher than that. It would likely be low. For example, in E. coli, only 3,000 μWs / cm² is needed to inhibit growth. 2 Only necessary However, to achieve a 100% lethality rate, 6,600 μWs / cm² is required. 2 It will be necessary. Control system The device 70 passes through a tube sufficient to suppress the growth of colonies of one or more target pathogens. The flow rate of the liquid, the intensity of the UV lamp 85, and the part of the housing in which the UV lamp 85 is used (for example) Refer to Figure 5B and the reflection conditions within the upper part 93) described below, the tube exposed to the UV lamp The structure, the distance between the tube and the UV lamp, and the spectrum emitted from the UV lamp 85 It can be pre-programmed to be set based on the susceptibility of the target pathogen.

[0095] Furthermore, referring to Figure 4, in some embodiments, the processor 70 and the valve control device 86 It can also communicate; alternatively, the valve control device 86 may be part of the functions of the processor 70. The valve control device 86 controls the flow of DSR infusion fluid between the reservoir, abdominal cavity, and bladder. It controls the operation of any valve that can be used for planting. For example, as described above with reference to Figure 1C, The swallowing device 20 blocks access to the bladder and thus prevents the fluid from being inadvertently swallowed into the bladder. With valves 49 and 49' activated to avoid pumping from the peritoneal cavity, DSR The system can be configured to pump the injectable fluid from an external or internal reservoir into the abdominal cavity; Furthermore, access to the reservoir of the fluid is blocked, and therefore the fluid is not inadvertently released into the abdominal cavity. With valves 49 and 49' activated to avoid pumping to the reservoir, The device can be configured to pump the fluid from the abdominal cavity to the bladder. Valve control device 86 In such a manner, or in other appropriate manner based on a particular valve configuration, valves 49 and 49' The operation can be adjusted.

[0096] Referring now to Figures 5A and 5B, further details of an exemplary embodiment of the planting device 90 Details are shown. In Figure 5A, the housing 91 is shown as transparent, but of course, the housing Zing 91 includes opaque biocompatible plastics, glass, and / or metal alloy materials. Please understand this. In Figure 5B, the lower part 92 of housing 91 is removed from the upper housing 93. Glass beads / epoxy are used to prevent moisture from accumulating inside the planting device. The planting device without filler material is shown. In Figures 5A and 5B, motor 94 is shown in Figure 6. It is connected to the gear pump housing 95, which is described in detail in reference to Figure 4. The electronic components are arranged on the circuit board 96, and the circuit board extends around the support member 97, It is fixed to the support member. Coil 98 (corresponding to coil 84 in Figure 4) is connected to the flat surface of the substrate. The coil is positioned at the top 99, and the flexible cable portion 101 connects to the electronic components on the flap 100. The support member 97 is fixed to the upper housing 93 and connected to the battery 102 (Figure 4 A cavity is defined to hold the battery 74. The lower part 92 of the housing 91 This reduces the space inside the housing where moisture can accumulate, by using the upper 93 and lower parts of the housing 91. Port 103 for injecting glass beads / epoxy mixture after parts 92 are fixed together. It is equipped with.

[0097] The housing 91 is also designed to restrict the movement of the implanted pump once it is implanted in the patient. The functional structure is designed to include, for example, suture holes that securely fix the implantation device to the surrounding tissue. This is possible. The housing 91 promotes adhesion of the implanted device to the surrounding tissue after subcutaneous implantation. It can also be equipped with a polyester implanted patch.

[0098] Furthermore, the implantation device contains an anti-obstruction agent, for example, a protein-based substance that particularly prevents fluid from the peritoneal cavity. Enzyme eluents that target components, particularly enzymes that target protein components and adhesion-promoting components of urine. Protein eluting agent, chemical elution surface, coating to prevent adhesion of protein components, and these Any combination of these can be provided. When such active substances are used, To integrate it into various components of the system, or to coat the surface of said components It is possible to do so.

[0099] Referring to Figure 5B, the upper housing 93 optionally includes a UV lamp 85. Upper housing Within 93, the channel 88 for guiding the liquid may extend in a nearly straight line, or it may be a UV ray One or more curved sections or bends to increase the amount of liquid that can be simultaneously exposed to the pump 86. It may be equipped with a section, and thus the flow rate can be increased. For example, the flow path 88 is the same as the UV lamp 86. Sometimes, to increase the amount of liquid that may be exposed, an approximate spiral, approximate sine wave, or approximate "S" It may have a curved section. The upper housing 93 enhances the irradiation of the tube and exposes potential UV To protect patients from light exposure, a reflective coating 87, such as a white coating of ZnO, is used. It may further include a ng, or other diffuse reflector or Lambert reflector.

[0100] Figures 6A to 6D provide further details of the gear pump and flow path. In Figures 6A to 6D, similar components are identified using the same reference numerals as in Figures 5A and 5B. Figure 6A shows the motor 94, the gear pump housing 95 and the upper housing 93, and the planting equipment. This is an exploded view showing the assembly of the components of the flow path inside the unit. The upper housing 93 is preferably This includes the inlet nipple 102, the outlet nipple 103, the pressure sensors 104a~104d, the manifold 105, and It can be molded or machined to have an opening and a passage for accommodating the screw 106. It includes high-strength plastic or metal alloy material. Nipples 102 and 103 are preferably, Machined from a high-strength biocompatible metal alloy, the outlet nipple 103 is elastic duckbill It further includes a passage 107 for housing the valve 108. The outlet nipple 103 houses the pressure sensor 104a. The pressure sensor further comprises a side recess 109, and the pressure sensor responds to the pressure inside the patient's bladder (or abdominal cavity). It is positioned to measure the pressure at the inlet end of the bladder catheter.

[0101] Furthermore, referring to Figures 6B and 6C, the inlet nipple 102 is located within the opening 110. The opening 110 includes an opening 111 of the pressure sensor 104b and an opening 112 that is connected to the manifold 105. A passage is formed in the upper housing 93. The pressure sensor 104b corresponds to the pressure inside the abdominal cavity. It is positioned to measure the pressure at the exit end of the membrane catheter. The outlet includes a duckbill valve 107. The nipple 103 has a side recess 108 that aligns with the opening 114 to access the electrical contacts of the pressure sensor 104a. It is positioned within the opening 113 of the upper housing 93 to allow pressure to escape. The passage 115 is formed with an opening 116 in the conductor 104c and an opening 117 that is connected to the manifold 105. The upper housing 93 preferably has a passage with an opening 119 for housing the pressure sensor 104d. It further comprises an opening 118 that is formed. The pressure sensor 104d measures the ambient pressure and this sensor Using the output, calculate the differential pressure as described above. The upper housing is connected to the inlet nipple 102. It holds the peritoneal catheter to be connected and the bladder catheter connected to the outlet nipple 103. The upper housing 9 further includes a notch 120 for accommodating a connector 26 (see Figure 1A). 3 is connected to a recess 121 that accommodates the manifold 105 and a support member 97 (see Figure 5B). It also comes equipped with peg 122.

[0102] The manifold 105 preferably has inlet and outlet passages connected via the upper housing 93 to the gears It has two separate flow paths connected to the pump (such as the flow path shown as 88 in Figure 5B). It is equipped with a moldable elastic element. The first flow path is equipped with an inlet 124 and an outlet 125, and the second flow path is equipped with an inlet It is equipped with 126 and an outlet 127. The inlet 124 is connected to the opening 112 of the peritoneal passage (see Figure 6C), and the outlet The opening 127 is connected to the opening 117 of the bladder passage. The manifold 105 is part of the structure of the upper housing 93. By simplifying the structure, the need to cast or machine components with complex nonlinear flow paths is eliminated. The planting device is configured to improve manufacturability by doing so. Motor 94 To ensure sufficient irradiation of the liquid when pumping it through the housing 93, optionally A UV lamp 86 and a surface 87 (not shown in Figures 6A to 6D) are connected to a manifold inside the housing 93. It can be positioned appropriately for the D105.

[0103] The motor 94 uses a screw thread 130 to allow its spline shaft 131 to pass through the bearing 132. It is connected to the vehicle pump housing 95. The gear pump of the present invention has an O-ring seal 135 and a pre Gears 133 and 134 that mesh with each other are sealed inside the gear pump housing 95 by the 136. It is equipped with the following. The gear pump is self-priming. Plate 136 is connected to the outlet 125 of manifold 105. It has a meeting opening 137 and an opening 138 that connects to the inlet 126. The spline shaft 131 of the motor 94 is It is inserted into the opening 139 of gear 133 and engages with the gear in a floating manner.

[0104] (Charging and communication system) Referring to Figures 7A, 7B, and 8, the charging and communication system 150 (corresponding to system 30 in Figure 1A) The following describes in detail the charging and communication system 150. It comprises a handpiece 151 and a base 31 (see Figure 1A). The base 31 supports the handpiece 151. A cradle for recharging is provided, preferably the handpiece 151 is mounted on the base. When the handpiece is charged, use the normal 120 / 220 / 240 V power or appropriate DC power. It is equipped with a converter and circuit for converting to electric current. Alternatively, the handpiece 151 is the hand It can be equipped with a circuit for charging the battery of the unit, and a detachable power cord. In this embodiment, the handpiece 151 is plugged directly into an outlet for charging. The power cord can be removed when recharging the implantation device using the handpiece. It will be removed.

[0105] As shown in Figure 8, the handpiece 151 is equipped with a control device 152, and the control device is Non-volatile memory 153 (for example, either EEPROM or flash memory), volatile memory 1 54, wireless transceiver 155, induction circuit 156, battery 157, indicator 158, and display It is exemplified as the processor of a microcontroller unit connected to I-159. Device 152, memory 153 and 154, and wireless transceiver 155 are a single microcontroller unit. For example, the MPS430 family available from Texas Instruments, Dallas, Tex. It can be incorporated into the cross processor. The transceiver 155 transmits information to the implantation device 20. It is connected to antenna 160 for transmitting and receiving signals. Battery 157 is connected to connector 161. The connector is detachably connected to the connector on the base 31 for charging the battery. Port 162, for example, a USB port or equivalent wireless circuit, is connected to handpiece 151. It is connected to the control device 152 so that information can be exchanged with the monitoring and control system. Induction circuit 156 is connected to coil 163. Input device 164 is preferably a multi-function button It is connected to the control device 152 so that the patient can input a limited number of commands. Indicator 158 is the power achieved between the handpiece and the implantation device. It lights up to indicate the quality of the charge coupling, and therefore the handpiece 151 in the implantation device while charging In one preferred embodiment, multiple LEDs are provided to help optimize the alignment. In this configuration, indicator 158 is omitted, and instead, the charge obtained from the coupling of coils 163 and 84 is shown. A bar graph indicating quality is displayed on display 159.

[0106] In one preferred embodiment, the handpiece 151 is connected to the corresponding implantation The device identification stored in the non-volatile memory 71 of the implantation device is configured to communicate only with device 20. It includes a device identifier stored in a non-volatile memory 153 corresponding to the child. Optionally, at the clinic The handpiece, which can be configured for use, is a unique device of the implantation apparatus. The monitoring and control system 40 requests an identifier and then mimics the patient's handpiece. It may have the ability to change the device identifier of the implanted device in the patient. Even if a patient forgets to bring their own handpiece 151 when visiting the clinic The doctor can adjust the settings of the implantation device.

[0107] The control device 152 stores information in a non-volatile memory 153 that controls communication and charging of the implantation device. The firmware is executed. The control unit 152 also, during clinic visits, via port 162 For subsequent retransmission to the monitoring and control system 40, the implantation device is sent to the handpiece 151. The system is configured to transfer and save the data being uploaded, for example, event logs. In another law, the handpiece 151 is used during a clinic visit to a designated wireless network within the clinic. To recognize access points and configure them to communicate wirelessly with the monitoring and control system 40. This is possible. As another method, the base 31 automatically dials the handpiece 151. Information stored in, for example, alarm information, can be accessed via a secure connection to the doctor's website. It can be equipped with a telephone line for uploading.

[0108] The control device 152 preferably has a low-power operation mode, and the control device periodically wakes up The internal clock moves to communicate with the implantation device, record data, or perform a charging function. It is equipped with a control device 152, which is preferably located near the planting device and is activated It performs communication and charging functions, and transmits commands entered using the input device 164. It is configured as follows. The control device 152 evaluates the information received from the implantation device and The program further includes a program for creating a message on display 159. Yes, it is possible. The control device 152 also uses the input device 164 to input commands to the implantation device. Send and execute such commands, for example, a gear pump to remove an obstacle. Firmware for monitoring the operation of the planting device during start or jog / vibration operation is also included. It can have. Furthermore, the control device 152 controls the induction circuit 156 during recharging of the implantation device. Operation, display of the charge status of battery 74, and control of the charging of battery 157 and information on the charge status It controls and monitors various output operations of the handpiece 151, including the display of reports.

[0109] The non-volatile memory 153 preferably includes flash memory or EEPROM and related A unique device identifier for the planting device, firmware executed by the control device 152, and configuration The set values ​​and optional coding performed by the transceiver 155 and / or induction circuit 156 Save the data. The firmware and setting data stored in the non-volatile memory 153 are saved to the port. Update using information supplied by the control and monitoring system 40 via the 162. This is possible. The volatile memory 154 is connected to the control device 152 and supports the operation of the control device. The system saves data and event log information uploaded from the planting device 20.

[0110] Furthermore, in one preferred embodiment, the non-volatile memory 153 communicates with the monitoring and control system. Even without trusting it, some initial startup functions can be performed by the charging and communication system. Save the program to enable it. In particular, memory 153 is used for the operation of "self-sufficient mode". Furthermore, it enables testing of the planting device during planting using only the charging and communication system. This may include a routine in which the doctor can manually start the pump using a button. It can be set up, and using the display 159, it can be determined whether the pump transport session was successful or not. It provides that feedback. It also uses the display 159 of the charging and communication system. This assists physicians in positioning implanted devices, peritoneal catheters, or bladder catheters. It can display error messages that are designed to be used in this way. These features are preferred Alternatively, it is disabled after the first planting in the planting device.

[0111] The transceiver 155 preferably uses, for example, a wireless communication system compliant with Bluetooth or the IEEE 802.11 wireless standard. A linear frequency transceiver is included, and via the antenna 160, the transceiver is located within the planting device. It is configured to communicate bidirectionally with the transmitter circuit 76. The transceiver 155 also operates in low power mode. It can have a code that can be activated periodically to receive arrival messages, and Respond only to messages containing a unique device identifier assigned to the relevant implantation device. The transceiver 155 preferably transmits messages to the implantation device or the implantation device Encryption routines are used to ensure that messages received from the device can never be intercepted or forged. To use.

[0112] The induction circuit 156 is connected to the coil 163 and inductively coupled to the coil 84 of the implantation device. The planting device is configured to recharge the battery 74. In one embodiment, induction Circuit 156 is connected to indicator 158, preferably a plurality of LEDs, which are It is lit to indicate the degree of electromagnetic coupling between Il 163 and 84 (and therefore the quality of the charge), and to this This further assists in the alignment of the handpiece 151 with respect to the implantation device. A preferred embodiment. In this case, when induction coils 84 and 163 operate at frequencies below 315 kHz, the gap is 35 mm. A good bond can be established. The implantation device is equipped with an optional infrared LED 83. In one embodiment, the charging and communication system 30 is equipped with an optional infrared sensor (not shown). The infrared sensor can detect infrared light emitted by the LED 83, and To optimize the electromagnetic coupling between coils 163 and 84, the alignment of the handpiece 151 was further adjusted. This provides support, which improves energy transfer to the planting device.

[0113] The control device 152 also periodically communicates with the planting device during inductive charging of the battery 74. The system is configured to collect temperature data generated by the temperature sensor 78 and save it to the memory 72. The control device 152 analyzes the battery temperature and sets a predetermined threshold, for example, body temperature. To maintain the temperature of the planting device below a temperature less than 2°C higher, the induction circuit 163 is used. It may have firmware that adjusts the charging power supplied. This threshold is the battery To reduce the thermal expansion of surrounding electronic and mechanical components, for example, motors and gears To reduce the thermal expansion of the components of the lamp, and between the lower 92 and upper 93 of the housing It can be set to reduce thermal strain on the rod. In one preferred embodiment, The power supplied to the induction coil 163 is high-voltage at charging intervals corresponding to the measured temperature inside the implantation device. It exhibits a periodic cycle between high power (e.g., 120 mA) and low power (e.g., 40 mA).

[0114] As described above regarding the induction circuit 75 of the planting device, the induction circuit 156 is the gear pump's fault. To remove harmful substances, use "boost" mode or jog mode, and the induction circuit 75 and battery It can be optionally configured to transmit additional power to the motor 73 of the planting device via 74. In particular, for example, if the motor 73 stops due to a blockage formed by a viscous liquid, When an alarm is transmitted to the control device 152, the input device 164 is used to remove the overvoltage from the induction circuit 75. The patient can be given the option to have the motor 73 remove the obstacle over a predetermined period of time. Alternatively, The operation of the input device 164 causes the control device 152 to rapidly operate the motor 74 in both the reverse and forward directions. By moving it, the gear pump is jogged or vibrated to perform a routine that breaks up blockages. Instructions can be issued to the processor 70 to do so. This mode of operation is different from normal operation. Because it can consume more energy than expected in the story, induction circuits 156 and 75 are The additional energy required for motor operation consumes the battery 74 of the planting device. Instead, configure it to be powered directly from the energy stored in battery 157. It is possible.

[0115] The battery 157 is preferably long-lasting, for example, capable of operating for up to 3 years. Includes lithium-ion batteries or lithium polymer batteries. Battery 157 is taken from base 31. When removed, the control device 152, transceiver 155, induction circuit 156, and related components are charged. It has sufficient capacity to supply power to the handpiece 151 in order to operate the connected electronic equipment. In one preferred embodiment, battery 157 powers the planting device battery 7 for approximately 2 to 4 hours. It has enough capacity to fully charge from a completely depleted state. Battery 157 also lasts about 2-4 hours. It should have the ability to be recharged within [time]. When transporting 700 ml of liquid in daily operations, Battery 157 and inductive circuit 156 transfer sufficient charge to battery 74 via inductive circuit 75. The battery should be able to be recharged within approximately 30 minutes. The battery capacity is preferable. The charge accumulator algorithm is used to charge the control device 152. Therefore, it is managed.

[0116] Referring again to Figures 7A and 7B, the handpiece 151 preferably has a multifunction button 166 ( (corresponding to the input device 164 in Figure 8) and display 167 (corresponding to the display 159 in Figure 8) It comprises a housing 165 having ). Multiple LEDs 168 are located in the translucent portion of the handpiece 151. Located below, these multiple LEDs correspond to indicator 158 in Figure 8. Port 169 (Figure 8) By connecting the handpiece to the monitoring and control system 40 (corresponding to port 162 of port 8), This allows the handpiece to be attached to the base 3 via connector 170 (corresponding to connector 161 in Figure 8). It can be connected to 1 to recharge the battery 157. The multifunction button 166 allows the patient to, A limited number of commands can be entered into the planting device. Display 167, preferred Alternatively, the desired input can be displayed on an OLED or LCD display using the multifunction button 166. The image confirms that the message has been received. Display 167 also shows the plant The charging status and stage of the battery 74 of the feeding device, and the charging status of the battery 157 of the handpiece 151. Status and stage, wireless communication signal strength, charging quality, error messages, and maintenance Messages can also be displayed. The induction coil portion 171 of the housing 165 is an induction coil It accommodates 163.

[0117] The LED 168 is visible through the material of the housing 165 when lit, preferably each Three rows are arranged with two LEDs per row. During charging, the LEDs light up, for example, in the induction circuit 156. The degree of electromagnetic coupling between induction coils 163 and 84 is determined by the energy loss from the The LED displays the patient's positioning of the handpiece 151 relative to the implantation device. This is possible. Therefore, for example, a low degree of coupling can be made to correspond to the lighting of only two LEDs, and a medium degree of coupling can be made. A degree of coupling is represented by the illumination of four LEDs, and a preferred degree of coupling is represented by the illumination of all six LEDs. It can be projected. Using this information, the patient can project images onto the area where the implantable device is located. By aligning the position of the handpiece 151, a preferred position for the handpiece can be obtained. As a result, the shortest recharge time is achieved. In one preferred embodiment, LED 168 is a charge-coupled This is replaced by an analog bar display on display 167, which indicates the quality of the match.

[0118] (Monitoring and control system) Now, referring to Figure 9, we will explain the software that runs the monitoring and control system in Figure 1A. Software 180 includes several functional blocks schematically shown in Figure 9. This functional block consists of a main block 184, an event log block 182, and a data download block. Block 183, Configuration Setup Block 184, User Interface Block 185, Health Alarm detection block 186 including status monitoring block 191 and infection prediction block 192, sensor Calibration block 187, firmware upgrade block 188, device identifier block 189 , and state information block 190. In one embodiment, this software is code in C++. It is also object-oriented, but does not use other software languages ​​and environments. It is also possible to do so. In one embodiment, this software is typically used on the desktop and wrapper. Microsoft Windows RTM (Microsoft Corporation, Redmond, Webmaster), used in top computers. (a registered trademark of sh.) or designed to run on Unix-based operating systems. While it is configured as such, other operating systems can also be used.

[0119] The computer running the monitoring and control system software 180 is preferably a It has a data port, for example, a USB port or equivalent wireless connection, which allows for charging and communication. The stem's handpiece 151 can be connected via port 169. Alternatively, the above For example, a computer may be equipped with a wireless card that conforms to the IEEE 802.11 standard. This allows the handpiece 151 to communicate wirelessly with a computer running software 180. It can be trusted. As a further alternative, the charging and communication system will automatically dial Then, the attending physician can access the data from the handpiece 151, such as alarm data. It can be equipped with a telephone line to upload to a secure website.

[0120] The main block 184 is preferably a physician's computer, tablet, or smartphone. It consists of the main software routines that run on the system, and the entire operation of other functional blocks. Control. When connected to the handpiece 151, the main block 184 controls the handpiece. Event data and alarm information stored on -151 can be accessed on your computer, tablet, etc. It can be downloaded to a PC or smartphone, and the control and monitoring software Toware 180 can also directly control the operation of the planting device. The doctor then uploads firmware updates and configuration data to the implantation device. It is also possible.

[0121] Event log block 182 is down from the planting device via the charging and communication system. This is a record of loaded operational data, including, for example, pump start and stop times, and more. Sensor data of the position of the urinary tract, abdominal and bladder pressure, patient's body temperature, respiratory rate, or body fluid temperature, and Pump outlet pressure, humidity, pump temperature, battery current, battery voltage, battery status This may include things like pump blockage, boost mode, etc. The event log also contains events, such as pump blockage, boost mode, etc. This may include operation in jog mode, alarms, or the occurrence of other abnormal conditions.

[0122] Data download block 183 is used by the handpiece 151 to monitor and control software 180 After connecting to the computer running the program, data is downloaded from volatile memory 154. This is a routine that controls communication with the handpiece in order to download data. Block 183 automatically, or under the guidance of a physician via the user interface block 185. This allows you to start downloading the data stored in the event log.

[0123] The configuration setup block 184 controls the operation of the implantation device in the non-volatile memory 71. This is a routine for setting saved parameters. Interval timing parameters are, for example, Before the processor starts up and receives wireless communication or controls the operation of the pump, the process You can decide how long to keep the processor in sleep mode. The timing parameters are, for example, the duration of the pumping action that transports fluid from the abdominal cavity to the bladder, and Periodic tic movements to suppress obstruction of implanted devices, peritoneal catheters, and bladder catheters. The spacing between plants can be controlled. Monitoring and control software 180 can be used to control the planting device. The transmission interval timing setting determines when and how often event data will be transmitted. It determines whether to write to the automatic memory 71 and the charging and communication system handpiece 151 Set the timing parameters used by the firmware executed by Rosser 152. It is also possible to use Block 184, which the doctor uses to control the processor 70 and motor 73. Parameters related to the limits of operation can be set in the non-volatile memory 71. These values ​​represent the minimum and maximum pressure of the peritoneal catheter and bladder catheter, and the pressure during charging. This may include the maximum temperature difference, the time the pump can operate, and the time the pump cannot operate. .

[0124] The limit set by block 184 controls the operation of the processor 152 of the handpiece 151. The parameters to be controlled are also set. Block 184 also controls the operation of the processor 70 and the motor 73. Sets parameters stored in the non-volatile memory 71 of the implantation device related to control. It is also possible. These values ​​represent the target daily amount of liquid to be transported and the amount per pump transport set. This includes the amount of liquid transported, the motor speed, and the duration of a single pumping session. It can be seen. Block 184 also moves in boost mode when connected to handpiece 151. In the game, and when the implantation device operates using only Battery 74, the vibration / jog mode is used. The operating parameters of the motor 73 inside can be specified. Such parameters are sequential Motor speed and voltage, and motor shaft rotation time when operating alternately in the forward and reverse directions. This may include rotational speed, etc.

[0125] User interface block 185 monitors via data download block 183 Controls the display of information retrieved from the visual and control systems and implantable devices, and allows physicians to... For further consideration, the information is presented in an intuitively easy-to-understand format. Refer to Figures 10-14. As explained below, this information includes the status of the planting device, charging and control system. The state of the pump, the measured pressure, the amount of liquid transported in one pumping session or per day, etc. It may include. User interface block 185 also allows doctors to enter information, block Regarding the 184, the interval timing parameters, limit parameter, and pump mentioned above We will also create a user interface screen that allows users to set operating parameters.

[0126] The alarm detection block 186 was recovered from the planting device or the charging and communication system. A routine to evaluate data and flag abnormal conditions to draw the doctor's attention. It may include. For example, the alarm detection block 186 may include the health status monitoring block 191. The health status monitoring block 191 can monitor the amount, time, and amount of DSR infusion fluid supplied to the patient's abdominal cavity. We will alert the doctor to any changes in the patient's health condition that may justify a change in the frequency of changes. It is configured as follows. For example, the data provided by the implantation device 20 is the fluid in the peritoneal cavity. If an accumulation is observed, the physician should determine the amount, time, and / or the amount of fluid being drawn from the patient's abdominal cavity. The frequency can be increased. Alternatively, the data provided by the implantation device 20 can be compared. If a relatively small amount of fluid is present, the physician should determine the amount, time, and amount of fluid drawn from the patient's abdominal cavity. / or the frequency can be reduced.

[0127] The alarm detection block 186 may also include a decompensation prediction block 192. The decompensation prediction block 192, for example, is used when the accumulation of fluid in the patient's abdominal cavity exceeds a predetermined threshold. An increase in the respiratory rate of patients exceeding a predetermined threshold, and / or an increase in intraperitoneal pressure exceeding a predetermined threshold. It is configured to predict or detect decompensated heart failure based on one or more elevations. Such flags are presented by user interface block 185. By changing the state of the dicator, or by using user interface block 185 Through this, medical information about the patient's fluid accumulation, respiratory rate, or increased intra-abdominal pressure can be obtained. This information can be conveyed to the physician by presenting it to the teacher.

[0128] The sensor calibration block 187 is used, for example, in planting devices due to changes over time or humidity. This may include routines for testing or measuring the drift of sensors 70, 78-81 used. Block 187 then calculates an offset value to correct the measurement data from the sensor. This information can then be transmitted to the implantation device for storage in the non-volatile memory 71. For example, pressure sensors 104a to 104d may experience drift due to aging or temperature changes. Therefore, block 187 can calculate the offset value, and then the offset value This data is sent to the implantation device and stored to account for such drift.

[0129] Firmware upgrade block 188 is installed in the planting device. Firmware of the regulator or motor control device and / or the charging and communication system process Check the firmware version number of the sasser and the upgraded firmware. It may include a routine to check whether the wear exists or not. If it exists, this routine This allows you to inform your doctor, who can then update the firmware using non-volatile media. Download or modify the firmware to save it to the Mori 71 planting device. It can be downloaded to the charging and communication system for storage in non-volatile memory 153. It becomes Noh.

[0130] Device identifier block 189 is an awareness of the implantation device stored in non-volatile memory 71. The Besshi, as well as the monitoring and control systems, are connected to the planting device via the charging and communication systems. This consists of a routine that reads this data when the implantation device is installed. Using a location identifier, wireless communications received from a charging and communication system are identified by that specific plant. Verify that it is for the device. Similarly, this information is provided to the handpiece 15 of the charging and communication system. 1 is used, and the received message is created by the implantation device associated with that handpiece. Determine whether or not it has been done. Finally, monitor and control the device identifier information. A180 is used to verify that the handpiece and implantation device constitute a compatible set. ru.

[0131] The status information block 190 indicates that when the handpiece is connected via 151, the implantation device is notified. In addition, current status data is collected from the implantation device and / or handpiece 151. This includes routines. Such information includes, for example, battery status, implantation device and handpiece. The internal clock date and time, currently used firmware and hardware This may include system management information and sensor data.

[0132] Now, referring to Figures 10 to 14, we see the user interface block 1 of software 180. An exemplary screen created by 87 is used in accordance with the method of the present invention to treat HF. This section describes a planting system. Figure 10 shows the operation of monitoring and control software 180. This shows the main screen 200 displayed to the doctor. The main screen 200 corresponds to block 190 in Figure 9. The routine retrieves status information from the implantation device and the charging and communication system and displays it. It has a state region that indicates the state for the charging and communication system. More specifically, the state region is the state for the charging and communication system. Area 201 (called "Smart Charger"), and state area 202 ("ALFA") for the implantation device. Includes a pump (called a pump). Each state area is indicated by a checkmark, each system An icon indicating whether the system is functioning correctly, the device identifier of the system, and each This includes whether the stem is connected or operational. If the parameter is outside the specification range... If evaluated by alarm detection block 186, the icon will instead display a warning message. It may include numbers. Menu bar 203 highlights each menu item by medical The teacher can move between various screens. The workspace area 204 is located below the state area. , and includes a display that changes depending on the selected menu item. Workspace area 204 Below it, a navigation panel 205 is displayed, and this navigation panel is soft Refresh the version number of Wear 180 and the display of the workspace area 204. Includes radio buttons for enabling the function.

[0133] In Figure 10, the menu bar 203 shows the submenu eye of the menu item "Information". The item "Planting Device" is highlighted. Selecting this menu item allows you to work. The pace area 204 is the battery status window 204a for the implantation device, and the measuring pressure window. Window 204b and firmware version management window 204c are shown as examples. The battery status window 204a includes an icon representing the remaining charge of battery 74, and is fully charged. It may also be expressed as "electric," "3 / 4 charged," "1 / 2 charged," "1 / 4 charged," or "battery level is almost zero." An alarm may be displayed as follows: The time component of window 204a is received from the implantation device. It shows the current time, the date is expressed in the format day / month / year, and the time is based on the 24-hour system. The time is expressed in the format hours / minutes / seconds. The measurement pressure window 204b includes bladder pressure, abdominal pressure, and ambient pressure. The forces are displayed in mBar units, measured by sensors 104a, 104b, and 104d (see Figure 6A). The version control window 204c shows the firmware version of processor 70, This indicates the version of the patient control device and the hardware version of the implantation device. The meter window 204d displays the patient's body temperature, respiratory rate, and intra-abdominal pressure. If the device includes other types of sensors, such as sensors that measure the level of fluids in the body, Note that parameters measured by such sensors can also be displayed in window 204d. I want to.

[0134] Alarm status window 204e indicates the possibility of decompensated heart failure or the patient's health condition. Any change in parameters that may indicate a change in the patient's health condition, such as improvement or deterioration. Display (blocks 191 and 192 in Figure 9). For example, as illustrated, alarm status Window 204e can alert a physician that the patient's intra-abdominal pressure is abnormally high, Therefore, doctors can monitor patients for the possibility of decompensation. In the administration method, based on the information displayed in windows 204b, 204d, and / or 204e, the physician However, for example, using the interface described below with reference to Figure 13, the pump The operating parameters can be adjusted.

[0135] Referring to Figure 11, the selection of the "Smart Charger" submenu item in Figure 10 corresponds to this. Screen display 206 is shown. Figure 11 is for the charging and communication system described above, with reference to Figure 10. State area 201, state area 202 for the planting device, menu bar 203, workspace area 204 , and navigation panel 205. Screen display 206 is "Smart Charger" submenu Unlike screen display 200, the workspace area 204 has items highlighted. Battery status window 207a and version management window for charging and control system The code 207b is displayed. The battery status window 207a shows the remaining charge of battery 157. It may include an icon and represent fully charged, 3 / 4 charged, 1 / 2 charged, and 1 / 4 charged, or This may indicate an alarm that the battery level is almost zero. Time component of window 207a The time displayed is the current time as received from handpiece 151, and the date is in the format day / month / year. It is represented as such, and the time is expressed in the format of hours / minutes / seconds based on the 24-hour system. Version control The ND207b is a firmware version of the processor 152, as well as a charging and control system. This indicates the hardware version of the device.

[0136] Referring to Figure 12, we see the "Download" menu item and "Log File" from Figure 10. Screen display 208 is shown corresponding to the selection of the "L" submenu item, and software 180 The function of lock 183 is executed. Figure 12 shows the state of the charging and communication system, all as described above. Area 201, implantation device status area 202, menu bar 203, workspace area 204, and Includes the Vision Panel 205. Screen display 208 is the "Log File" submenu item. Unlike the "Information" screen display in that it is highlighted, the workspace area 204 is The download progress window 209a and the save path window 209b are displayed. The Dou 209a downloads event logs from the planting device via the charging and communication system. This includes the directory path that can be accessed. Windows 209a also has an event log. "Open Download Folder" allows doctors to select the directory path where downloads will occur. Radio buttons and a progress bar that updates to reflect the amount of data downloaded. -Includes. Window 209b operates and logs the event log to the specified time in Window 209a. The path includes radio buttons that allow downloading, and also allows canceling the download process. This also includes the "Cancel" radio button.

[0137] Figure 13 shows the "Pump Settings" menu item and the "Liquid Transport" submenu item from Figure 10. This is an exemplary representation of the screen display 210 corresponding to the selection of the element, and is part of block 18 of the software 180. Functions 4 and 190 are performed. Figure 13 shows the state of the charging and communication system, all as described above. Area 201, implantation device status area 202, menu bar 203, workspace area 204, and navigation Includes gate panel 205. Screen display 210 highlights the "Liquid Transport" submenu item. Unlike the "Information" screen display in that it is displayed, the workspace area 204 is set Liquid volume window 211a, liquid transport program window 211b, minimum daily volume window 2 11c, pressure window 211d, and the values ​​entered in windows 211a, 211b, and 211d are entered. Navigation panel 20 that can be transmitted to and stored in the non-volatile memory 71 of the loading device Includes 5 radio buttons.

[0138] The session volume window 211a is the pumping session of fluids that naturally accumulate in the peritoneal cavity. The time interval between operations, the number of times the pump can be operated per day, the total daily pump operation time, It also displays the current settings for the session volume of a single pump transport session. The residence time displayed in ND211a allows the physician to determine how long the DSR infusion solution remains in the abdominal cavity. It can be determined. The time interval displayed in window 211a allows the doctor to determine the sodium Set the frequency for drawing the DSR infusion solution containing the mu and the osmotic ultrafiltration solution from the abdominal cavity and directing them towards the bladder. This is possible (the DSR injection fluid from the reservoir into the peritoneal cavity can also be set in the same way). The amount of DSR injector delivered from the reservoir, residence time, and withdrawal time are related to the system's dynamics. This is used by the configuration setting routine (block 184 in Figure 9) to determine the overall configuration.

[0139] The optional time intervals in which the pump can be operated, displayed in window 211a, are: Define the time frame in which the feeding device can actively transport fluid to the bladder: these time Outside of the designated section, the planting equipment cannot transport liquid, but the above-mentioned pump tool By performing the operation and rotating the gears periodically, it is possible to prevent the gears from stopping. Depending on the patient's recognized health condition, the physician may determine that in some situations, maintaining health outweighs convenience. To achieve this, it is possible to set time intervals so that the pump can operate 24 hours a day, day and night. The daily pump operating time displayed in window 211a is entered in the time interval box. Since it is the sum of the time intervals, it is shown in read-only format. Finally, in window 211a The displayed session volume is the amount of fluid transferred to the bladder in one pumping session. This is then calculated by block 183.

[0140] The liquid transport program window 211b uses block 184 of software 180 to measure parameters This displays the status of the program that controls the operation of the planting device's pump based on the data set. If you need to stop the pump for any reason, see window 211b " You can stop the liquid transport program by clicking the "Off" button. As a result, the pump stops pumping until it is manually switched on. One embodiment The liquid transport program is activated by pressing the "On" button in window 211b. The switch can be turned on again. The planting device preferably has a pump switch. Because the device is implanted with the choke turned off, the doctor or surgeon will first implant the implantation device. Afterward, the liquid transport program can be activated using window 211b.

[0141] The minimum daily volume window 211c is the amount of fluid pumped into the bladder by the implantation device. The predicted quantity is displayed, and this predicted quantity is entered in window 211a by the configuration setup routine. Based on the length of the prescribed time interval and the timing of the time intervals, the session volume is calculated per day. It is calculated by multiplying by the number of sessions.

[0142] The pressure window 211d in Figure 13 is used by physicians to control the operation of the implantation pump. The values ​​of the maximum bladder pressure and minimum abdominal pressure to be used can be entered. Therefore, for example, The sessa 70 detects when the bladder pressure detected by the pressure sensor exceeds the specified value in window 211d. Then, a command is sent to motor 73 to stop the current pump transport session, or win Skip the planned pump transport session during the time interval that can be confirmed in DO211a. Similarly, the processor 70 determines the intra-abdominal pressure detected by the pressure sensor within the specified window 211d. If the value is lower than the specified value, a command is sent to motor 73 to stop the current pump transport session. or skip the planned pump transport session during the time interval that can be viewed in window 211a. To insert the implanted device, if configured to operate as described above, the implanted device will insert into the patient's bladder. Excessive filling can cause discomfort to the patient, and excessive fluid drainage from the abdominal cavity is also a concern. stomach.

[0143] Referring to Figure 14, we see the "Test" menu item and the "Manual Test Run" sub-item in Figure 11. Figure 14 shows an example representation of screen display 212 corresponding to the selection of a new item. All of the above, state area 201 of the charging and communication system, state area 202 of the implantation device, Includes menu bar 203, workspace area 204, and navigation panel 205. Display 212 indicates that the "Manual Test Run" submenu item is highlighted, which is an "information" Unlike the screen display, the workspace area 204 includes the manual pump cycle window 213. The manual pump cycle window 213 includes a radio button "Start Test," and the radio The "Start Test" button sends a command to the implantation device via the charging and communication system. Then, processor 70 causes the pump to operate for a predetermined period of time, for example, a few seconds. The sessa 70 receives position data from the Hall effect sensor of the motor 73, and pressure sensors 104c and 10 The 4D receives measured pressure data. The processor 70 calculates the session amount and processes that information. The information is sent back to software 10 via the charging and communication system, and the software then measures By comparing the data with the target session volume, the test results, for example, the achieved target session volume, are evaluated. The percentage or pass / fail icon will be displayed. Measured session volume, target set The amount of ion and the test results are displayed in window 213.

[0144] Although various exemplary embodiments of the present invention have been described above, those skilled in the art will not deviate from the present invention. It will be clear that various changes and modifications can be made without any problems. For example, System 10 This includes additional devices configured to assess the patient's physical and / or mental health, for example. , weighing scale, ECG or heart rate sensor, or sodium and / or in a drop of the patient's blood These include toxins and / or waste products, such as ammonia, C-reactive proteins, plasma renin, Serum sodium, serum creatinine, prothrombin time, and / or bilirubin It can be modified to include a portable biosensor to measure serum creatisphere. When connected to a sensor that measures nin, the system uses the above formula to determine the current GFR value. It can be configured to calculate and save. When configured in this way, the system If the GFR is calculated to be below 15, discontinue the use of no- or low-sodium DSR infusion. This allows a doctor to be notified.

[0145] Alternatively, or furthermore, system 10 may measure the subject's psychological health or electrophysiological activity. Modify the device to include a portable or computer-based device for presenting patients with psychological tests. Such a device can monitor the patient's health and the operating parameters of the implantable device 20. A system for monitoring and controlling outcomes for use by physicians when assessing the potential need for adjustments. It can be configured to provide wirelessly to the M40. The attached claims are as described in the present invention. Intended to encompass all such changes and modifications within the true spirit and scope. ru.

[0146] (Preliminary experimental results) Initial testing of the DSR injection solution and method of the present invention has been conducted in a pig model, which is the basis for the present invention. Effective insights into the system, methods, and how DSR infusions behave in humans. It is expected to provide... As will be explained in more detail below, its initial tests have shown that... It yielded exceptionally good and beneficial results, far exceeding expectations.

[0147] In the first group of 5 pigs ("protocol-improved pigs"), 1 liter of sodium-free DSR was injected. The effect of injecting the solution into the peritoneal cavity of each pig was measured. The DSR injection solution generally consisted of purified water and dextroit. It contains troll (for example, 10 grams per 100 ml of water) and remains in the peritoneal cavity for up to 6 hours. They used 5-25 microcuries of I-131 radiolabeled albumin as a non-absorbable tracer. The ultrafiltration dynamics were determined by mixing it with the infusion fluid without requiring continuous abdominal drainage. During the period, fluid samples were taken from the peritoneal cavity to determine the total amount of sodium removed and the amount accumulated in the peritoneal cavity. The sodium concentration of the liquid was determined as a function of time, and blood samples were also collected. For this, 1.5 hours after injecting the DSR infusion solution, 3 ml of blood sample and 2.5 ml of liquid sample were mixed in 15 ml. Samples were collected and analyzed every minute. Over the next hour and a half, blood and fluid samples were collected every 30 minutes. The sample was taken at [location]. Then, during the last three hours, additional blood and fluid samples were taken every hour. Furthermore, the sodium-containing DSR infusion solution and osmotic ultrafiltration solution accumulated in the abdominal cavity The total volume of the liquid was recorded as a function of time.

[0148] Figure 15A shows the total amount of sodium removed as a function of residence time for the first group of pigs. 15B shows the sodium concentration in the sample removed from the peritoneal cavity as a function of time. Figure 15C shows the total amount of fluid accumulated in the peritoneal cavity of the first group of pigs. As you can see, surprisingly, after 2 hours, the injection of 1 liter of DSR solution resulted in 1 liter The osmotic filtration fluid from the urinary tract accumulated in the abdominal cavity.

[0149] In the second group of 10 pigs ("protocol pigs"), during a 2-hour residence period, 1 liter of D SR infusion solution was injected into the peritoneal cavity of each pig. During the retention period, the serum sodium and serum osmolality of the pigs were monitored. Plasma osmolality and glucose levels will be measured by taking 6 ml blood samples every 30 minutes. Therefore, measurements were taken regularly. Total osmolality of fluids accumulating in the abdominal cavity, glucose osmolality The degree and non-glucose osmolality were measured regularly during the residence period using the aforementioned samples. The following measurements were taken: the total amount of fluid drained from the abdominal cavity and the amount of sodium removed after the residence period was completed. The total amount was measured.

[0150] Figure 16A shows the total volume of fluid removed from the peritoneal cavity of each protocol pig after a 2-hour retention period. Figure 16B shows the amount of sodium removed from the peritoneal cavity of each protocol pig after a 2-hour retention period. The total volume is shown. Figure 16C shows the liquid sample from the peritoneal cavity of protocol pigs during a 2-hour retention period. Changes in total osmolality of Plu, glucose osmolality, and non-glucose osmolality Figures 16D, 16E, and 16F show the serum of protocol pigs during a 2-hour residence period. The changes in sodium, serum osmolality, and serum glucose are shown, respectively. The above results The DSR method and infusion solution of the present invention are used in a single administration of 1 liter of DSR infusion solution and retention for 2 hours. It removes a clinically significant amount of sodium, for example 4,000 mg, but serum sodium levels are low. The effect on Bell has been demonstrated to be clinically negligible. 4,000 mg of sodium is removed. Sodium is generally equivalent to two days' worth of recommended sodium intake, which is stored through urination. Removal of the solidified liquid, and the significantly accumulated (1 liter in the studied parameters) osmotic limit This results in the direct removal of the filtrate from the peritoneal cavity. And, as shown in Figures 16D, 16E, and 16F As such, a single dose of DSR infusion with a retention time of 2 hours was expected to result in clinically manageable serum With only an increase in glucose concentration, serum sodium levels and serum osmolality remained stable throughout the period. Because it had that much safety, it is expected to be very safe.

[0151] Figures 17A and 17C show both the five pros before and after repeated application of the method of the present invention. This shows measurements of several blood volume markers in subgroups of the tocourge pig population. Figure 17A shows a nearly 50% reduction in total blood volume in protocol pigs after 5 cycles of DSR treatment. As expected, Figure 17B shows that the DSR method has virtually no effect on the total amount of red blood cells. However, Figure 17C shows that there is a decrease of approximately 60% in plasma volume. Therefore, As shown in Figures 17A to 17C, repeated use of the DSR method of the present invention reduces plasma volume. It has been demonstrated that a significant reduction in blood volume can be achieved by doing so. The effectiveness of the DSR method and how to use it to resolve different levels of fluid overload. It is demonstrating whether it can be used for that purpose.

[0152] Figure 18 shows the effects of using the DSR infusion solution of the present invention in patients with reduced residual renal function. The serum sodium concentration in the same subgroup of five protocol pigs was determined in order to perform the following study. This shows the effect on the degree. As shown in Figure 18, pigs experience a decrease in sodium and body fluids. Continuous application of the method of the present invention, which does not have the opportunity to restore serum sodium levels This results in a severe decline. The pigs are virtually nephroditic due to severe kidney damage caused by reduced blood volume. Yes. Figures 17A-17C and 18 show severe renal impairment (i.e., disease stage) with an amount sufficient for dialysis. 5. CKD or GFR <15 ml / min / 1.73m 2 The use of sodium-free or low-sodium infusions in patients is, This can lead to dangerous or end-stage hyponatremia and a decrease in plasma volume resulting in circulatory collapse. This suggests that it should be so. Therefore, as described above, the DSR method, injection solution, and The device is for patients with fluid overload and heart failure who currently have a GFR value greater than 15 or chronic kidney disease (CKD) of stage 4 or lower. The target should be those individuals.

[0153] Although various exemplary embodiments of the present invention have been described above, those skilled in the art will know that they will not deviate from the present invention. It will be clear that various changes and modifications are possible within the scope of the present invention without exception. For example, the pump system 1 can be commanded in various ways, and in more or less various ways. The size components and compositions may also be included. The attached claims represent the true essence of the present invention. This includes all such changes and modifications that fall under God and the scope.

Claims

1. (i) dextrose in an amount of 0.5 to 50 grams per 100 ml of aqueous solution, (ii) icodextrin in an amount of 0.5 to 50 grams per 100 ml of aqueous solution, or (iii) a high molecular weight glucose polymer having a weight average molecular weight of >10,000 in an amount of 0.5 to 50 grams per 100 ml of aqueous solution; or (iv) an aqueous solution comprising any combination thereof; and Infusion fluids containing a sodium concentration of 35 meq / L or less.

2. 10. The infusion solution of claim 1, wherein the infusion solution is essentially sodium free.

3. 10. The infusion solution of claim 1, further comprising an electrolyte selected from a magnesium salt and a calcium salt.

4. 10. The infusion solution of claim 1, wherein the infusion solution further comprises an antibacterial agent.

5. 10. The infusion solution of claim 1, further comprising an antifungal agent.

6. 10. The infusion solution of claim 1, further comprising a buffering agent.

7. 10. The infusion solution of claim 1, wherein the infusion solution is for use in treating heart failure by removing excess sodium in a patient.

8. 8. The method of claim 7, wherein the heart failure is congestive heart failure.

9. Patients with residual renal function may achieve a renal flow rate of 15 ml / min / 1.73 m 2 The method of claim 7, wherein the patient is a patient with an estimated glomerular filtration rate of greater than 100 mg / kg.

10. 8. The method of claim 7, wherein the patient with residual renal function is a patient with renal function ranging from normal to CKD stage 4.

11. 8. The infusion solution of claim 7, wherein the infusion solution is administered by injection into and drained from the patient's peritoneal cavity.

12. 12. The infusion solution of claim 11, wherein the infusion solution is formulated to maintain sufficient viscosity after a two hour residence period in the peritoneal cavity such that the infusion solution, excess sodium, and ultrafiltrate can be pumped from the peritoneal cavity to the patient's bladder using an implantable pump.

13. 8. The infusion solution of claim 7, wherein the infusion solution is formulated to be sufficiently viscous so that the infusion solution can be infused from a reservoir into the abdominal cavity via gravity feed.

14. 10. The infusion solution of claim 1, wherein the infusion solution removes excess sodium to reduce fluid overload in the patient while maintaining serum sodium levels substantially unchanged.

15. 10. The infusion solution of claim 1, wherein the infusion solution has an osmolality selected to induce diffusion of ultrafiltrate into the peritoneal cavity during a dwell period of at least 2 hours.

16. 10. The infusion solution of claim 1, wherein the infusion solution comprises purified water.

17. 10. The infusion solution of claim 1, wherein the infusion solution is sodium-free.

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