Kidney perfusion device

Abstract

The invention discloses a kidney perfusion device and a use method thereof. The kidney perfusion device comprises a blood / perfusate reservoir, a normal temperature / low temperature mode switching module, a normal temperature blood perfusion passage, a low temperature perfusate perfusion passage, a renal artery connector and a renal vein connector. The kidney perfusion device mainly aims at autologous kidney transplantation, not only supports conventional low-temperature perfusate perfusion through a low-temperature perfusion passage, but also supports ischemia-free perfusion through a normal-temperature perfusion passage. Necessary substances and conditions needed by kidney repair are provided through the normal-temperature perfusion module, the original function of the kidney can be rapidly recovered, if no-ischemia perfusion cannot be smoothly achieved under the conditions or no-ischemia perfusion needs to be stopped, conventional low-temperature perfusion can be rapidly converted, the thrombosis risk is reduced, and the kidney survival rate is increased.

Description

Technical Field

[0001] The present invention belongs to the field of medical devices, and in particular relates to a kidney perfusion device and a method of using the same. Background Art

[0002] Autologous kidney transplantation is one of the treatment options for complex kidney-related diseases, such as complex renal vascular diseases, long or upper ureteral lesions, low back pain and hematuria syndrome, renal tumors that are difficult to resect in vivo, and complex retroperitoneal tumors involving the ureter and renal blood vessels.

[0003] When the above-mentioned renal vascular lesions, ureteral lesions, tumors, etc. occur in anatomically or functionally single kidney, or when both kidneys are affected at the same time, autologous kidney transplantation has unique advantages due to its good preservation of renal units and renal function, and is an ideal choice for these patients with absolute kidney preservation needs.

[0004] High-quality donors are the fundamental condition for successful organ transplantation. In the process of conventional autologous kidney transplantation, the blood supply of the renal artery and vein needs to be ligated and cut off, cold perfusion is performed, and then the kidney is transplanted to the patient's own iliac fossa. The ischemia-reperfusion injury that inevitably occurs during this process will affect renal function. Therefore, a device that allows the kidney to be perfused with normal temperature blood in the body is needed to reduce the damage caused by renal ischemia-reperfusion. At the same time, the low-temperature perfusion mode can be used as a backup when there is no sufficient blood supply from the blood bank and the patient's financial conditions do not allow it. Summary of the invention

[0005] The present invention aims to solve at least one of the technical problems existing in the prior art. To this end, the present invention proposes a kidney perfusion device with a dual mode of normothermic / hypothermic, which can take into account both normothermic blood perfusion and hypothermic perfusion fluid perfusion according to the needs of the patient. The normothermic perfusion mode can reduce the risk of delayed graft function recovery (DGF), while the hypothermic perfusion mode is more widely applicable and economical, and at the same time serves as a necessary and timely backup perfusion pathway when performing blood perfusion.

[0006] The invention also provides a method for using the kidney perfusion device.

[0007] A kidney perfusion device according to a first aspect of the present invention includes a blood / perfusion fluid reservoir, a normal temperature / low temperature mode switching module, a normal temperature blood perfusion pathway, a low temperature perfusion fluid perfusion pathway, a renal artery connector, and a renal vein connector;

[0008] The blood / perfusate reservoir is used to separately store blood and perfusate;

[0009] The input end of the normal temperature / low temperature mode switching module is connected to the blood / perfusion liquid reservoir, the output end of the normal temperature / low temperature mode switching module is connected to the input end of the normal temperature blood perfusion passage, and the output end of the normal temperature / low temperature mode switching module is simultaneously connected to the input end of the low temperature perfusion liquid perfusion passage;

[0010] The input end of the renal artery connector is connected to the output end of the normal temperature blood perfusion pathway, and the input end of the renal artery connector is simultaneously connected to the output end of the low temperature perfusion fluid perfusion pathway, and the output end of the renal artery connector is used to communicate with the renal artery of the kidney to perfuse the blood or the perfusion fluid into the renal artery of the kidney;

[0011] The input end of the renal vein connector is used to communicate with the renal vein of the kidney, and the output end of the renal vein connector is connected to the blood / perfusion fluid reservoir.

[0012] According to some embodiments of the present invention, the low-temperature perfusion fluid perfusion pathway includes a first filter, a first flow rate controller, a first bubble filter, a first centrifugal pump, a first bubble detector and a first renal artery pressure control module, the first filter, the first flow rate controller, the first bubble filter, the first centrifugal pump, the first bubble detector and the first renal artery pressure control module are connected in sequence through a low-temperature perfusion pipeline, the input end of the first filter is connected to the output end of the normal temperature / low temperature mode switching module, and the output end of the first renal artery pressure control module is connected to the input end of the renal artery connector.

[0013] According to some embodiments of the present invention, the low-temperature perfusion fluid perfusion path further comprises a temperature display, and the temperature display is disposed between the first bubble detector and the first renal artery pressure control module.

[0014] According to some embodiments of the present invention, the normothermic blood perfusion pathway includes a second filter, a second flow rate controller, an oxygenator, a second bubble filter, a second centrifugal pump, a second bubble filter, a second centrifugal pump, a second bubble detector, a blood oxygen detector, a metabolite detector, and a second renal artery pressure control module; the second filter, the second flow rate controller, the oxygenator, the second bubble filter, the second centrifugal pump, the second bubble detector, the blood oxygen detector, the metabolite detector, and the second renal artery pressure control module are sequentially connected through the normothermic perfusion pipeline; the input end of the second filter is connected to the output end of the normothermic / low temperature mode switching module; the output end of the second renal artery pressure control module is connected to the input end of the renal artery connector; the oxygenator is used to fully oxygenate low-oxygen venous blood into high-oxygen arterial blood; the blood oxygen detector is used to detect the level of blood oxygen content in the blood; and the metabolite detector is used to detect the level of metabolic waste in the blood.

[0015] According to some embodiments of the present invention, a display control panel is also included, and the first flow rate controller, the temperature display, the first renal artery pressure control module, the second flow rate controller, the second bubble detector, the blood oxygen detector, the metabolite detector and the second renal artery pressure control module are all electrically connected to the display control panel.

[0016] According to some embodiments of the present invention, the blood / perfusion fluid reservoir includes multiple layers of thermal insulation material and a temperature control device, and the temperature control device is electrically connected to the display control panel.

[0017] According to some embodiments of the present invention, the temperature control device includes a heating element, a cooling element, a heating switch and a cooling switch.

[0018] According to some embodiments of the present invention, a urine detector is also included, and the urine detector is connected to the kidney.

[0019] A method for using a kidney perfusion device according to a second aspect of the present invention includes a normothermic perfusion mode and a hypothermic perfusion mode;

[0020] The normothermic perfusion mode comprises the following steps:

[0021] A1: Switch the normal temperature / low temperature mode switching module to the normal temperature perfusion mode, and confirm that the normal temperature / low temperature mode switching module is connected to the normal temperature blood perfusion pathway at this time;

[0022] A2: Take out the renal artery connector and the renal vein connector for standby use;

[0023] A3: Turn on the heating switch of the blood / perfusate reservoir and the second centrifugal pump, so that the refrigerated fresh blood in the blood / perfusate reservoir is preheated and transported to the normal temperature blood perfusion passage;

[0024] A4: After the blood flow is restored to stability, the second filter, the second flow rate controller, the oxygenator, the second bubble filter, the second centrifugal pump, the second bubble detector, the blood oxygen detector, the metabolite detector and the second renal artery pressure control module are turned on;

[0025] A5: connecting the input end of the renal vein connector to the ligated and cut renal vein of the kidney;

[0026] A6: Connect the output end of the renal artery connector to the renal artery that has been ligated and cut off, thereby maintaining the temperature by the patient's body temperature, and establishing an in situ normothermic mechanical perfusion circuit of the kidney. The venous blood of the kidney enters the blood / perfusion fluid reservoir through the renal vein connector, and is filtered of large impurities by the second filter, and the flow rate is controlled by the second flow rate controller. The blood is then oxygenated by the oxygenator, so that the venous blood becomes arterial blood. The second bubble filter removes excess bubbles, and then the second centrifugal pump provides power to simulate the heart pulse to perfuse the blood. The gas that has not yet been integrated into the blood is filtered out by the second bubble filter, and the second bubble detector detects that there is indeed no gas remaining. The current blood condition is detected by the blood oxygen detector and the metabolite detector, and the second renal artery pressure control module is used to adjust the blood pressure to an appropriate level, and the arterial blood is delivered to the renal artery, thereby providing blood and nutrients to the kidney during the autologous kidney repair period to maintain the function of the kidney.

[0027] The hypothermic perfusion mode comprises the following steps:

[0028] B1: Turn on the cooling switch of the blood / perfusion fluid reservoir, and the perfusion fluid in the blood / perfusion fluid reservoir is precooled;

[0029] B2: Switching the normal temperature / low temperature mode switching module to the low temperature perfusion mode, and confirming that the normal temperature / low temperature mode switching module is now connected to the low temperature perfusion liquid perfusion passage;

[0030] B3: connecting the input end of the renal vein connector to the renal vein of the kidney, and connecting the output end of the renal artery connector to the renal artery of the kidney;

[0031] B4: Turn on the first centrifugal pump, the first filter, the first flow rate controller, the first bubble filter, the first bubble detector, the temperature display, and the first renal artery pressure control module, thereby establishing a hypothermic perfusion circuit for the autologous kidney, and the hypothermic perfusion fluid in the blood / perfusion fluid reservoir is transported to the renal artery of the kidney.

[0032] According to some embodiments of the present invention, the flow rate, temperature and perfusion pressure are also adjusted through a display control panel.

[0033] The kidney perfusion device and the method of using the same according to the embodiments of the present invention have at least the following beneficial effects:

[0034] 1) The kidney perfusion device of the present application combines the advantages of both hypothermic perfusion and normothermic blood perfusion technologies, integrates surgical instruments as much as possible, and simplifies surgical operations.

[0035] The kidney perfusion device of the present application supports both low-temperature perfusion of low-temperature perfusion fluid and normothermic perfusion of normothermic blood (i.e., non-ischemic perfusion). The normothermic perfusion module provides the necessary substances and conditions for kidney repair, allowing the kidney to quickly restore its original function. If non-ischemic perfusion cannot be smoothly achieved due to limited conditions, or if non-ischemic perfusion cannot be performed and needs to be terminated, it can be quickly converted to conventional low-temperature perfusion to reduce the risk of thrombosis and improve kidney survival rate.

[0036] Compared with the traditional organ perfusion device, the present application highly integrates the implementation methods of hypothermic perfusion fluid perfusion and normothermic non-ischemic perfusion transplantation, and plays the role of the heart and lung outside the body after the autologous renal artery and vein are cut off, and continuously transports blood to the device for oxygenation and then resupplies the abdominal organs in the body to maintain their normal physiological activity, thereby avoiding the damage to the donor organ caused by ischemia during the operation under the premise of being in line with ethics, and truly realizing the whole process of autologous kidney transplantation without ischemia;

[0037] 2) The method for using the in situ normothermic / hypothermic dual-mode perfusion device for abdominal organs based on autologous kidney transplantation of the present application includes a liquid storage device for regulating temperature;

[0038] 3) The in situ normothermic / hypothermic dual-mode perfusion device for abdominal organs based on autologous kidney transplantation proposed in this application uses a centralized control panel to visually control various parameters.

[0039] Additional aspects and advantages of the present invention will be given in part in the following description and in part will be obvious from the following description, or will be learned through practice of the present invention. BRIEF DESCRIPTION OF THE DRAWINGS

[0040] The above and / or additional aspects and advantages of the present invention will become apparent and easily understood from the description of the embodiments in conjunction with the following drawings, in which:

[0041] Figure 1 Schematic diagram of the working principle of the kidney perfusion device according to an embodiment of the present invention.

[0042] Reference numerals:

[0043] Kidney 10;

[0044] Blood / perfusate reservoir 100; normal temperature / low temperature mode switching module 200; normal temperature blood perfusion passage 300; low temperature perfusate perfusion passage 400; renal artery connector 500; renal vein connector 600; display control panel 700; urine detector 800;

[0045] first filter 410; first flow rate controller 420; first bubble filter 430; first centrifugal pump 440; first bubble detector 450; first renal artery pressure control module 470; temperature display 460;

[0046] A second filter 301 ; a second flow rate controller 302 ; an oxygenator 303 ; a second bubble filter 304 ; a second centrifugal pump 305 ; a second bubble detector 306 ; a blood oxygen detector 307 ; a metabolite detector 308 ; and a second renal artery pressure control module 309 . DETAILED DESCRIPTION

[0047] Embodiments of the present invention are described in detail below, examples of which are shown in the accompanying drawings, wherein the same or similar reference numerals throughout represent the same or similar elements or elements having the same or similar functions. The embodiments described below with reference to the accompanying drawings are exemplary and are only used to explain the present invention, and cannot be understood as limiting the present invention.

[0048] In the description of the present invention, it should be understood that descriptions involving orientations, such as up, down, front, back, left, right, etc., and orientations or positional relationships indicated are based on the orientations or positional relationships shown in the accompanying drawings, and are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore should not be understood as a limitation on the present invention.

[0049] In the description of the present invention, "several" means more than one, and "more" means more than two. If there is a description of "first" or "second", it is only used for the purpose of distinguishing technical features, and cannot be understood as indicating or implying relative importance or implicitly indicating the number of the indicated technical features or implicitly indicating the order of the indicated technical features.

[0050] In the description of the present invention, "several" means one or more, "more" means more than two, "greater than", "less than", "exceed" etc. are understood as not including the number itself, and "above", "below", "within" etc. are understood as including the number itself. If there is a description of "first" or "second", it is only used for the purpose of distinguishing the technical features, and cannot be understood as indicating or implying the relative importance or implicitly indicating the number of the indicated technical features or implicitly indicating the order of the indicated technical features.

[0051] In the description of the present invention, unless otherwise clearly defined, terms such as setting, installing, connecting, etc. should be understood in a broad sense, and technicians in the technical field can reasonably determine the specific meanings of the above terms in the present invention in combination with the specific content of the technical solution.

[0052] In the description of the present invention, reference to the terms "one embodiment", "some embodiments", etc. means that the specific features, structures, materials or characteristics described in conjunction with the embodiment are included in at least one embodiment of the present invention. In this specification, the schematic representation of the above terms does not necessarily refer to the same embodiment. Moreover, the specific features, structures, materials or characteristics described can be combined in any suitable manner in one or more embodiments.

[0053] Kidney autotransplantation (KAT) is one of the treatment options for complex kidney-related diseases, such as complex renal vascular diseases, long or upper ureteral lesions, low back pain and hematuria syndrome, renal tumors that are difficult to resect in vivo, and complex retroperitoneal tumors involving the ureter and renal blood vessels.

[0054] In 1962, the first human autologous kidney transplantation (KAT) was performed to treat a 54-year-old man with high ureteral obstruction. Currently, the most common surgical indications for KAT are renal artery lesions, ureteral lesions and malignant tumors.

[0055] Autologous kidney transplantation is a safe and effective surgical method for the treatment of complex renal artery disease. The incidence of major postoperative complications of autologous kidney transplantation is 9.4%, and the rate of autologous transplant kidney loss is 4.1%. The postoperative primary arterial patency rate of autologous kidney transplantation for complex renal artery disease is 90.8%-100%, and the primary arterial patency rate is 75%-93% 2-8 years after surgery. The cure rate + remission rate of patients with hypertension after autologous kidney transplantation is 56.3%-61.0%.

[0056] Ureteral injury is a common urological complication during pelvic surgery, with an incidence of 1% to 10%. With the widespread use of ureteroscopy, the incidence of ureteral injury has also increased, ranging from 0.5% to 10%. Patients with ureteral lesions often undergo multiple medical interventions, especially complex ureteral lesions, which makes the management of ureteral lesions more complicated. In addition to autologous renal transplantation and ileal ureteral replacement, surgical methods including endoscopic treatment, ureter-ureter anastomosis, ureterovesical reimplantation, Boari bladder flap ureteral replacement, buccal mucosal repair and appendix interposition can be selected according to the location and length of the ureteral lesion. Autologous renal transplantation can be used as an alternative to the above surgical methods, as well as an effective choice for upper, long and complex ureteral lesions.

[0057] In fact, all complex ureteral lesions can be considered for autologous kidney transplantation. Tran et al. retrospectively analyzed 41 cases of complex ureteral strictures treated with laparoscopic-assisted autologous kidney transplantation. Most of them were caused by iatrogenic injuries during urinary tract stone surgery. The average length of the stricture was 4 cm, and the stricture segment was mostly located in the upper ureter. After an average follow-up of 63 months, 3 patients underwent autologous transplant nephrectomy, and the remaining 4 patients had complications.

[0058] For localized renal cancer, radical nephrectomy and partial nephrectomy are both treatment options. The indication for autologous renal transplantation is complex renal tumors that cannot be removed in situ technically under the premise of organ preservation, such as central renal tumors or tumors involving the renal hilum. The Oxford experience showed that the recurrence rate of their 37 T3 renal cell carcinomas within 10 years after autologous renal transplantation was 5.4%, and the overall graft survival rate and patient survival rate of 50 patients after 10 years were 82% and 75%, respectively.

[0059] When the above-mentioned renal vascular lesions, ureteral lesions, tumors, etc. occur in anatomically or functionally single kidney, or when both kidneys are affected at the same time, autologous kidney transplantation has unique advantages due to its good preservation of renal units and renal function, and is an ideal choice for these patients with absolute kidney preservation needs.

[0060] During conventional autologous kidney transplantation, the blood supply to the renal artery and vein needs to be ligated and cut off, cold perfusion is performed, and then the kidney is transplanted to the patient's own iliac fossa. The ischemia-reperfusion injury that inevitably occurs during this process will affect renal function.

[0061] Therefore, a device that allows normal temperature blood perfusion of the kidney in vivo is needed to reduce the damage of renal ischemia-reperfusion. At the same time, a low temperature perfusion mode can be used as a backup when there is no sufficient blood supply from the blood bank and the patient's economic conditions do not allow it.

[0062] Based on this, the present invention provides a kidney 10 perfusion device, the purpose of which is to provide an in situ abdominal organ normothermic / hypothermic dual-mode perfusion device based on autologous kidney transplantation, which can take into account both normothermic blood perfusion and hypothermic perfusion fluid perfusion according to patient needs. Normative perfusion can reduce the risk of DGF, while hypothermic perfusion is more widely applicable and economical, and can also serve as a necessary and timely backup perfusion pathway when performing blood perfusion.

[0063] Reference Figure 1 The kidney perfusion device according to the first embodiment of the present invention is a normal temperature and low temperature perfusion device for abdominal organs based on autologous kidney transplantation without interruption of blood flow. Of course, it can be understood that the kidney perfusion device can also be used in other situations, which are not specifically limited here.

[0064] Reference Figure 1 The kidney perfusion device according to the first embodiment of the present invention includes a blood / perfusion fluid reservoir 100, a normal temperature / low temperature mode switching module 200, a normal temperature blood perfusion passage 300, a low temperature perfusion fluid perfusion passage 400, a renal artery connector 500, and a renal vein connector 600.

[0065] The blood / perfusate reservoir 100 is used to store blood and perfusate separately. The blood input end is connected to a blood bag and the blood / perfusate reservoir 100 , and the perfusate input end is connected to refrigerated transplant kidney perfusate and the blood / perfusate reservoir 100 .

[0066] The input end of the normal temperature / low temperature mode switching module 200 is connected to the blood / perfusion fluid reservoir 100, the output end of the normal temperature / low temperature mode switching module 200 is connected to the input end of the normal temperature blood perfusion passage 300, and the output end of the normal temperature / low temperature mode switching module 200 is simultaneously connected to the input end of the low temperature perfusion fluid perfusion passage 400, so as to drain the arterial blood output from the blood / perfusion fluid reservoir 100 back to the donor renal artery through the normal temperature blood perfusion passage 300 or the output low temperature perfusion fluid through the low temperature perfusion fluid perfusion passage 400.

[0067] The input end of the renal artery connector 500 is connected to the output end of the normal temperature blood perfusion passage 300, and the input end of the renal artery connector 500 is also connected to the output end of the low temperature perfusion fluid perfusion passage 400. The output end of the renal artery connector 500 is used to communicate with the renal artery of the kidney 10 to perfuse blood or perfusion fluid into the renal artery of the kidney 10.

[0068] An input end of the renal vein connector 600 is used to communicate with the renal vein of the kidney 10 , and an output end of the renal vein connector 600 is connected to the blood / perfusate reservoir 100 .

[0069] The kidney perfusion device of the present application combines the advantages of both low-temperature perfusion and normal-temperature blood perfusion technologies, integrates surgical instruments as much as possible, and simplifies surgical operations.

[0070] The kidney perfusion device of the present application supports both low-temperature perfusion of low-temperature perfusion fluid and normothermic perfusion of normothermic blood (i.e., non-ischemic perfusion). The normothermic perfusion module provides the necessary substances and conditions for the repair of the kidney 10, which can quickly restore the kidney 10 to its original function. If the non-ischemic perfusion cannot be smoothly achieved due to limited conditions, or if the non-ischemic perfusion cannot be carried out and needs to be stopped, it can be quickly converted to conventional low-temperature perfusion, reducing the risk of thrombosis and improving the survival rate of the kidney 10.

[0071] Compared with traditional organ perfusion devices, the present application highly integrates the implementation methods of hypothermic perfusion fluid perfusion and normothermic non-ischemic perfusion transplantation, and plays the function of acting as an extracorporeal heart and lung after the autologous renal artery and vein are cut off, continuously transporting blood to the device for oxygenation and then resupplying the abdominal organs in the body to maintain their normal physiological activity. In this way, the damage to the donor organ caused by ischemia during the operation is avoided under the premise of being in line with ethics, and ischemia-free autologous kidney transplantation is truly achieved throughout the process.

[0072] Reference Figure 1 In some embodiments of the present invention, the low-temperature perfusion fluid perfusion passage 400 includes a first filter 410, a first flow rate controller 420, a first bubble filter 430, a first centrifugal pump 440, a first bubble detector 450 and a first renal artery pressure control module 470. The first filter 410, the first flow rate controller 420, the first bubble filter 430, the first centrifugal pump 440, the first bubble detector 450 and the first renal artery pressure control module 470 are connected in sequence through a low-temperature perfusion pipeline. The input end of the first filter 410 is connected to the output end of the normal temperature / low temperature mode switching module 200, and the output end of the first renal artery pressure control module 470 is connected to the input end of the renal artery connector 500.

[0073] The low-temperature perfusion fluid perfusion passage 400 is used for low-temperature conventional perfusion fluid perfusion of the kidney 10. The first filter 410 is connected to the normal temperature / low temperature mode switching module 200 to filter the impurities visible to the naked eye in the perfusion fluid flowing from the blood / perfusion fluid reservoir 100. The first flow rate controller 420 is located on the low-temperature perfusion pipeline between the first filter 410 and the first bubble filter 430, and is used to control the flow rate of the perfusion fluid, thereby affecting the perfusion pressure. The first bubble filter 430 is located on the perfusion pipeline between the first flow rate controller 420 and the first centrifugal pump 440, and is used to filter out bubbles in the perfusion fluid. The first centrifugal pump 440 is located on the normal temperature perfusion passage between the first bubble filter 430 and the first renal artery pressure control module 470, and is used to provide power for the low-temperature perfusion fluid. The first renal artery pressure control module 470 is connected to the renal artery connector 500, and is used to input the low-temperature perfusion fluid with bubble removal at a suitable pressure into the renal artery.

[0074] Reference Figure 1 In some embodiments of the present invention, the low-temperature perfusion fluid perfusion passage 400 further includes a temperature display 460, which is disposed between the first bubble detector 450 and the first renal artery pressure control module 470. The temperature display 460 is used to display the temperature of the perfusion fluid so that doctors and nurses can know the temperature of the perfusion fluid at any time.

[0075] Reference Figure 1 In some embodiments of the present invention, the normothermic blood perfusion pathway 300 includes a second filter 301, a second flow rate controller 302, an oxygenator 303, a second bubble filter 304, a second centrifugal pump 305, a second bubble filter 304, a second centrifugal pump 305, a second bubble detector 306, a blood oxygen detector 307, a metabolite detector 308, and a second renal artery pressure control module 309. 6. The blood oxygen detector 307, the metabolite detector 308 and the second renal artery pressure control module 309 are connected in sequence through the normal temperature perfusion pipeline. The input end of the second filter 301 is connected to the output end of the normal temperature / low temperature mode switching module 200, and the output end of the second renal artery pressure control module 309 is connected to the input end of the renal artery connector 500. The oxygenator 303 is used to fully oxygenate the low-oxygen venous blood into high-oxygen arterial blood. The blood oxygen detector 307 is used to detect the blood oxygen content level in the blood. The metabolite detector 308 is used to detect the level of metabolic waste in the blood.

[0076] The normothermic blood perfusion passage 300 is used for normothermic non-ischemic perfusion of the kidney 10. The second filter 301 is arranged on the normothermic perfusion pipeline between the blood / perfusion liquid storage 100 and the second flow rate controller 302, and is used to filter out larger impurities in the blood while trying to avoid damage to blood cells. The second flow rate controller 302 is arranged on the normothermic perfusion pipeline between the second flow rate controller 302 and the oxygenator 303, and is used to control the blood flow rate. The oxygenator 303 is located on the normothermic perfusion pipeline between the second flow rate controller 302 and the second bubble filter 304, and is used to fully oxygenate the low-oxygen venous blood into high-oxygen arterial blood. The second bubble filter 304 is located on the normothermic perfusion pipeline between the oxygenator 303 and the second centrifugal pump 305, and is used to filter out insoluble gases in the blood or free oxygen not bound to hemoglobin. The second centrifugal pump 305 is located on the normal temperature perfusion path between the second bubble filter 304 and the second bubble detector 306, and is used to provide power for blood perfusion. The second bubble detector 306 is located on the normal temperature perfusion path between the second centrifugal pump 305 and the blood oxygen detector 307, and is used to detect whether there are residual bubbles in the blood. The blood oxygen detector 307 is located on the normal temperature perfusion path between the second bubble detector 306 and the metabolite detector 308, and is used to detect the level of blood oxygen content in the blood. The metabolite detector 308 is located on the normal temperature perfusion path between the blood oxygen detector 307 and the second renal artery pressure control module 309, and is used to detect the level of metabolic wastes such as urea and creatinine in the blood. The second renal artery pressure control module 309 connects the metabolite detector 308 with the renal artery connector 500 to control the blood pressure perfused into the renal artery.

[0077] Reference Figure 1 In some embodiments of the present invention, a display control panel 700 is also included, and the first flow rate controller 420, the temperature display 460, the first renal artery pressure control module 470, the second flow rate controller 302, the second bubble detector 306, the blood oxygen detector 307, the metabolite detector 308 and the second renal artery pressure control module 309 are all electrically connected to the display control panel 700, and the display control panel 700 is used to evaluate the state of the kidney 10 according to the perfusion parameters of each working device.

[0078] Reference Figure 1 In some embodiments of the present invention, the blood / perfusate reservoir 100 includes multiple layers of thermal insulation material and a temperature control device, and the temperature control device is electrically connected to the display control panel 700 to control the working state of the temperature control device and control the temperature parameters of the blood and perfusate in the blood / perfusate reservoir 100.

[0079] Reference Figure 1In some embodiments of the present invention, the temperature control device includes a heating element, a cooling element, a heating switch and a cooling switch, so that the blood and perfusate in the blood / perfusate reservoir 100 reach a set temperature.

[0080] Reference Figure 1 In some embodiments of the present invention, a urine detector 800 is also included. The urine detector 800 is connected to the kidney 10 to detect whether there is urine.

[0081] The embodiment of the present application supports both conventional perfusion through the hypothermic perfusion pathway and non-ischemic perfusion through the blood perfusion pathway. The necessary substances and conditions required for the repair of the kidney 10 are provided through the normothermic perfusion module, so that the kidney 10 can quickly restore its original function. If non-ischemic perfusion cannot be smoothly achieved due to limited conditions, or if non-ischemic perfusion cannot be performed and needs to be terminated, it can be quickly converted to conventional hypothermic perfusion, reducing the risk of thrombosis and improving the survival rate of the kidney 10.

[0082] A method for using a kidney perfusion device according to a second aspect of the present invention includes a normothermic perfusion mode and a hypothermic perfusion mode;

[0083] Normothermic perfusion mode includes the following steps:

[0084] A1: Switch the normal temperature / low temperature mode switching module 200 to the normal temperature perfusion mode, and confirm that the normal temperature / low temperature mode switching module 200 is connected to the normal temperature blood perfusion passage 300 at this time;

[0085] A2: Take out the renal artery connector 500 and the renal vein connector 600 for future use;

[0086] A3: Turn on the heating switch of the blood / perfusate reservoir 100 and the second centrifugal pump 305, and the refrigerated fresh blood in the blood / perfusate reservoir 100 is preheated and transported to the normal temperature blood perfusion passage 300;

[0087] A4: After the blood flow is restored to stability, the second filter 301, the second flow rate controller 302, the oxygenator 303, the second bubble filter 304, the second centrifugal pump 305, the second bubble detector 306, the blood oxygen detector 307, the metabolite detector 308 and the second renal artery pressure control module 309 are turned on;

[0088] A5: Connect the input end of the renal vein connector 600 to the ligated and severed renal vein of the kidney 10;

[0089] A6: The output end of the renal artery connector 500 is connected to the renal artery of the kidney 10 that has been ligated and cut off. Thus, the temperature is maintained by the patient's body temperature, and the in situ normothermic mechanical perfusion circuit of the kidney 10 is established. The venous blood of the kidney 10 enters the blood / perfusion fluid reservoir 100 through the renal vein connector 600, and large impurities are filtered by the second filter 301. The flow rate is controlled by the second flow rate controller 302, and then oxygenated by the oxygenator 303, so that the venous blood becomes arterial blood, and the excess is filtered out by the second bubble filter 304. The second centrifugal pump 305 provides power to simulate the heart pulse to perfuse blood, the second bubble filter 304 filters out the gas that has not yet been integrated into the blood, and the second bubble detector 306 detects that there is indeed no gas left, the blood oxygen detector 307 and the metabolite detector 308 detect the current blood condition, and the second renal artery pressure control module 309 adjusts the blood pressure to a suitable blood pressure, and delivers arterial blood to the artery of the kidney 10, thereby providing blood and nutrients to the kidney 10 during the autologous kidney repair period to maintain the function of the kidney 10;

[0090] The hypothermic perfusion mode includes the following steps:

[0091] B1: Turn on the cooling switch of the blood / perfusate reservoir 100, and the perfusate in the blood / perfusate reservoir 100 is precooled;

[0092] B2: Switch the normal temperature / low temperature mode switching module 200 to the low temperature perfusion mode, and confirm that the normal temperature / low temperature mode switching module 200 is connected to the low temperature perfusion liquid perfusion passage 400 at this time;

[0093] B3: Connect the input end of the renal vein connector 600 to the renal vein of the kidney 10 , and connect the output end of the renal artery connector 500 to the renal artery of the kidney 10 ;

[0094] B4: Turn on the first centrifugal pump 440, the first filter 410, the first flow rate controller 420, the first bubble filter 430, the first bubble detector 450, the temperature display 460, and the first renal artery pressure control module 470, thereby establishing a low-temperature perfusion circuit for the autologous kidney 10, and the low-temperature perfusion fluid in the blood / perfusion fluid reservoir 100 is transported to the renal artery of the kidney 10.

[0095] Example 1

[0096] This embodiment uses an in situ abdominal organ normothermic / hypothermic dual-mode perfusion device based on autologous kidney transplantation to perform non-ischemic normothermic perfusion and autologous kidney transplantation on patients. The specific process is as follows:

[0097] Switch the renal artery circulation module to the normal temperature perfusion mode, confirm that the pathway selection is correct, remove the arterial connection end and the venous connection end for use, turn on the heating switch of the blood / perfusion fluid reservoir 100 for preheating, input refrigerated fresh blood into the liquid pathway, turn on the second centrifugal pump 305, and start the normal temperature perfusion pathway.

[0098] After the above operations are completed and confirmed to be correct, and the blood flow is restored to stability, the detection control switches are turned on, including: the second filter 301, the second flow rate controller 302, the oxygenator 303, the second bubble filter 304, the second centrifugal pump 305, the second bubble filter 304, the second bubble detector 306, the blood oxygen detector 307 and the metabolite detector 308, and the second renal artery pressure control module 309. Ensure that all parts work normally and operate normally.

[0099] Autologous kidney 10 removal surgery (taking the removal of autologous right kidney 10 in the case of renal artery stenosis as an example): After successful endotracheal anesthesia, the patient lies flat, and routine disinfection and draping are performed; a midline abdominal incision is made, and the skin, subcutaneous tissue, and muscle layer are cut layer by layer, and the abdomen is entered to separate and expose the right renal vein and right renal artery. The renal fascia is opened, the peritoneum is pushed forward, the right kidney is exposed, the ureter is found in front of the psoas major muscle, and the ureter is lifted with a vascular sling and freed downward to the pelvis. The perirenal fat is freed outside the renal lamina propria, and the adrenal gland is separated at the suprarenal level. The left renal vein is separated, and the genital vein and other branches are ligated and cut off. The renal vein is ligated and cut off with No. 7 silk thread, and the renal vein is connected to the renal vein and fixed, and the distal end of the renal vein connection end is blocked with a blocking clamp to prevent blood from flowing out of the portal vein. The proximal end of the left renal artery is separated and exposed between the inferior vena cava and the abdominal aorta, and the No. 7 silk thread is ligated and cut off, and the renal artery connector 500 is connected to the proximal end of the renal artery and properly fixed. The ureter is connected to a urine collection device. Thus, the temperature is maintained by the patient's body temperature, and an in situ normothermic mechanical perfusion circuit of the autologous kidney 10 is established.

[0100] After the renal vein connection end is connected to the renal vein, and the renal artery connector 500 is connected to the renal artery, the venous blood enters the blood / perfusion fluid storage 100 through the blood input end, is filtered of large impurities by the second filter 301, and the flow rate is controlled by the second flow rate controller 302, and then is oxygenated by the oxygenator 303, so that the venous blood becomes arterial blood, and the excess bubbles are filtered out by the second bubble filter 304, and then the second centrifugal pump 305 provides power to simulate the heart pulse to perfuse the blood, and the gas that has not yet been integrated into the blood is filtered out by the second bubble filter 304, and the second bubble detector 306 detects that there is indeed no gas remaining, and the current blood condition is detected by the blood oxygen detector 307 and the metabolite detector 308, and the second renal artery pressure control module 309 is used to adjust the blood pressure to a suitable level, and the arterial blood is transported to the donor artery. The arterial blood will flow to the kidney 10 in the donor body, thereby providing blood, nutrients, etc. to the kidney 10 to maintain the function of the kidney 10 during the autologous kidney repair.

[0101] Autologous kidney repair: Keep the kidney 10 in place, check the color and texture of the kidney 10, confirm whether there is any deformity or damage, cut the surrounding tissue along the renal artery, and free it to about 2 cm away from the renal hilum. Start trimming the ureter from the distal end, retain an appropriate amount of surrounding tissue, and retain the fat tissue and mesentery around the lower ureter. The process always keeps the kidney 10 fully perfused with blood.

[0102] Autologous kidney 10 implantation surgery: fully free the right internal iliac artery and the right common iliac vein. Without stopping the perfusion, the kidney 10 and the perfusion tube were horizontally placed into the right iliac fossa; the renal vein and the right common iliac vein were anastomosed end to side with a 6-0 prolene line; the renal artery and the right internal iliac artery were anastomosed end to side with an 8-0 prolene suture. During the entire vascular anastomosis process, mechanical perfusion was continued at room temperature to ensure that the blood flow of the donor liver portal vein and hepatic artery was not interrupted. The renal vein of the autologous kidney was anastomosed end to side with the right external iliac vein, and the renal artery was anastomosed end to side with the right external iliac artery. The abdominal cavity was cleaned, bleeding was stopped accurately, and the abdomen was closed after the drainage tube was placed. During this process, the blood flow of kidney 10 was always uninterrupted.

[0103] So far, the autologous kidney 10 has maintained uninterrupted blood flow throughout the four processes, including in situ normothermic regional perfusion, autologous kidney 10 acquisition surgery, non-ischemic autologous kidney repair surgery, and non-ischemic autologous kidney implantation surgery, completely avoiding ischemia-reperfusion injury, thereby achieving the best transplantation effect.

[0104] During this process, the flow rate, temperature and perfusion pressure can be adjusted via the display control panel 700 .

[0105] Example 2

[0106] This embodiment uses an in situ abdominal organ normothermic / cold dual-mode perfusion device based on autologous kidney transplantation to perform non-ischemic normothermic perfusion and transplantation of autologous kidney transplantation on patients, and quickly switches to hypothermic perfusion when non-ischemic perfusion cannot be performed normally. The specific process is as follows:

[0107] The process of obtaining an autologous transplanted kidney, connecting the renal vein connection end to the renal vein, and connecting the renal artery connector 500 to the renal artery is the same as that of Example 1.

[0108] After a period of in vivo perfusion through the normothermic perfusion support pathway, the pathway could not function normally due to some reason, and it was decided to terminate the ischemia-free normothermic perfusion.

[0109] Turn on the refrigeration switch of the blood / perfusion liquid storage 100 for precooling, disconnect the renal vein connection end from the renal vein, stop transporting blood from the blood input end to the passage, input the refrigerated renal perfusion liquid into the liquid passage through the perfusion liquid input end, at this time, the renal artery connector 500 is still connected to the normal temperature perfusion passage, after the liquid in this passage changes from red to clear, the renal artery circulation module is switched to the low temperature perfusion mode, after confirming that the passage is changed correctly, turn on the first centrifugal pump 440, and start the low temperature perfusion passage. At the same time, turn on each detection control switch, including: the first filter 410, the first flow rate controller 420, the first bubble filter 430, the temperature display 460, and the first renal artery pressure control module 470. Ensure that each part works normally and operates normally.

[0110] The first filter is connected to the blood / perfusion fluid storage 100 for storing the perfusion fluid. The first filter can remove impurities in the filtered fluid, and then the flow rate is controlled by the first flow rate controller 420. After the bubbles are filtered out by the first bubble filter 430, the current temperature of the perfusion fluid is displayed. After the pressure is adjusted by the first renal artery pressure control module 470, the perfusion fluid is connected to the kidney 10 through the renal artery connection section for perfusion. In this process, the flow rate, temperature and perfusion pressure can be adjusted through the display control panel 700.

[0111] The kidney perfusion device of the present application combines the advantages of both low-temperature perfusion and normal-temperature blood perfusion technologies, integrates surgical instruments as much as possible, and simplifies surgical operations.

[0112] The kidney perfusion device of the present application supports both low-temperature perfusion of low-temperature perfusion fluid and normothermic perfusion of normothermic blood (i.e., non-ischemic perfusion). The normothermic perfusion module provides the necessary substances and conditions for kidney repair, allowing the kidney to quickly restore its original function. If non-ischemic perfusion cannot be smoothly achieved due to limited conditions, or if non-ischemic perfusion cannot be performed and needs to be terminated, it can be quickly converted to conventional low-temperature perfusion to reduce the risk of thrombosis and improve kidney survival rate.

[0113] Compared with traditional organ perfusion devices, the present application highly integrates the implementation methods of hypothermic perfusion fluid perfusion and normothermic non-ischemic perfusion transplantation, and plays the function of acting as an extracorporeal heart and lung after the autologous renal artery and vein are cut off, continuously transporting blood to the device for oxygenation and then resupplying the abdominal organs in the body to maintain their normal physiological activity. In this way, the damage to the donor organ caused by ischemia during the operation is avoided under the premise of being in line with ethics, and ischemia-free autologous kidney transplantation is truly achieved throughout the process.

[0114] The method for using the in situ normothermic / hypothermic dual-mode perfusion device for abdominal organs based on autologous kidney transplantation of the present application includes a temperature-regulating liquid storage device.

[0115] The in situ normothermic / hypothermic dual-mode perfusion device for abdominal organs based on autologous kidney transplantation proposed in this application uses a centralized control panel to visually control various parameters.

[0116] As described above, the above embodiments are only used to illustrate the technical solutions of the present application, rather than to limit them. Although the present application has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the aforementioned embodiments, or make equivalent replacements for some of the technical features therein. However, these modifications or replacements do not deviate the essence of the corresponding technical solutions from the spirit and scope of the technical solutions of the embodiments of the present application.

[0117] The technical features of the above-described embodiments may be arbitrarily combined. To make the description concise, not all possible combinations of the technical features in the above-described embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0118] The present embodiment is described in detail above in conjunction with the accompanying drawings, but the present invention is not limited to the above embodiment, and various changes can be made within the knowledge scope of ordinary technicians in the technical field without departing from the present purpose.

Claims

1. A kidney perfusion device, characterized in that: It includes a blood / perfusion fluid reservoir, a normal temperature / low temperature mode switching module, a normal temperature blood perfusion pathway, a low temperature perfusion fluid perfusion pathway, a renal artery connector, and a renal vein connector; The blood / perfusate reservoir is used to separately store blood and perfusate; The input end of the normal temperature / low temperature mode switching module is connected to the blood / perfusion liquid reservoir, the output end of the normal temperature / low temperature mode switching module is connected to the input end of the normal temperature blood perfusion passage, and the output end of the normal temperature / low temperature mode switching module is simultaneously connected to the input end of the low temperature perfusion liquid perfusion passage; The input end of the renal artery connector is connected to the output end of the normal temperature blood perfusion pathway, and the input end of the renal artery connector is simultaneously connected to the output end of the low temperature perfusion fluid perfusion pathway, and the output end of the renal artery connector is used to communicate with the renal artery of the kidney to perfuse the blood or the perfusion fluid into the renal artery of the kidney; The input end of the renal vein connector is used to communicate with the renal vein of the kidney, and the output end of the renal vein connector is connected to the blood / perfusion fluid reservoir.

2. The kidney perfusion device according to claim 1, characterized in that The low-temperature perfusion fluid perfusion pathway includes a first filter, a first flow rate controller, a first bubble filter, a first centrifugal pump, a first bubble detector and a first renal artery pressure control module. The first filter, the first flow rate controller, the first bubble filter, the first centrifugal pump, the first bubble detector and the first renal artery pressure control module are connected in sequence through a low-temperature perfusion pipeline. The input end of the first filter is connected to the output end of the normal temperature / low temperature mode switching module, and the output end of the first renal artery pressure control module is connected to the input end of the renal artery connector.

3. The renal perfusion device according to claim 2, characterized in that The low-temperature perfusion fluid perfusion path further includes a temperature display, which is disposed between the first bubble detector and the first renal artery pressure control module.

4. The kidney perfusion device according to claim 3, characterized in that The normothermic blood perfusion pathway includes a second filter, a second flow rate controller, an oxygenator, a second bubble filter, a second centrifugal pump, a second bubble filter, a second centrifugal pump, a second bubble detector, a blood oxygen detector, a metabolite detector, and a second renal artery pressure control module. The second filter, the second flow rate controller, the oxygenator, the second bubble filter, the second centrifugal pump, the second bubble detector, the blood oxygen detector, the metabolite detector, and the second renal artery pressure control module are sequentially connected through the normothermic perfusion pipeline. The input end of the second filter is connected to the output end of the normothermic / low temperature mode switching module. The output end of the second renal artery pressure control module is connected to the input end of the renal artery connector. The oxygenator is used to fully oxygenate venous blood with low oxygen content into arterial blood with high oxygen content. The blood oxygen detector is used to detect the level of blood oxygen content in the blood. The metabolite detector is used to detect the level of metabolic waste in the blood.

5. The kidney perfusion device according to claim 4, characterized in that It also includes a display control panel, and the first flow rate controller, the temperature display, the first renal artery pressure control module, the second flow rate controller, the second bubble detector, the blood oxygen detector, the metabolite detector and the second renal artery pressure control module are all electrically connected to the display control panel.

6. The kidney perfusion device according to claim 5, characterized in that The blood / perfusion fluid storage device includes multiple layers of heat-insulating materials and a temperature control device, and the temperature control device is electrically connected to the display control panel.

7. The kidney perfusion device according to claim 6, characterized in that The temperature control device comprises a heating element, a cooling element, a heating switch and a cooling switch.

8. The renal perfusion device according to claim 7, characterized in that Also included is a urine detector connected to the kidney.

9. A method for using the kidney perfusion device according to claim 7 or 8, characterized in that: Includes normothermic perfusion mode and hypothermic perfusion mode; The normothermic perfusion mode comprises the following steps: A1: Switch the normal temperature / low temperature mode switching module to the normal temperature perfusion mode, and confirm that the normal temperature / low temperature mode switching module is connected to the normal temperature blood perfusion pathway at this time; A2: Take out the renal artery connector and the renal vein connector for standby use; A3: Turn on the heating switch of the blood / perfusate reservoir and the second centrifugal pump, so that the refrigerated fresh blood in the blood / perfusate reservoir is preheated and transported to the normal temperature blood perfusion passage; A4: After the blood flow is restored to stability, the second filter, the second flow rate controller, the oxygenator, the second bubble filter, the second centrifugal pump, the second bubble detector, the blood oxygen detector, the metabolite detector and the second renal artery pressure control module are turned on; A5: connecting the input end of the renal vein connector to the ligated and cut renal vein of the kidney; A6: Connect the output end of the renal artery connector to the renal artery that has been ligated and cut off, thereby maintaining the temperature by the patient's body temperature, and establishing an in situ normothermic mechanical perfusion circuit of the kidney. The venous blood of the kidney enters the blood / perfusion fluid reservoir through the renal vein connector, and is filtered of large impurities by the second filter, and the flow rate is controlled by the second flow rate controller. The blood is then oxygenated by the oxygenator, so that the venous blood becomes arterial blood. The second bubble filter removes excess bubbles, and then the second centrifugal pump provides power to simulate the heart pulse to perfuse the blood. The gas that has not yet been integrated into the blood is filtered out by the second bubble filter, and the second bubble detector detects that there is indeed no gas remaining. The current blood condition is detected by the blood oxygen detector and the metabolite detector, and the second renal artery pressure control module is used to adjust the blood pressure to an appropriate level, and the arterial blood is delivered to the renal artery, thereby providing blood and nutrients to the kidney during the autologous kidney repair period to maintain the function of the kidney. The hypothermic perfusion mode comprises the following steps: B1: Turn on the cooling switch of the blood / perfusion fluid reservoir, and the perfusion fluid in the blood / perfusion fluid reservoir is precooled; B2: Switching the normal temperature / low temperature mode switching module to the low temperature perfusion mode, and confirming that the normal temperature / low temperature mode switching module is now connected to the low temperature perfusion liquid perfusion passage; B3: connecting the input end of the renal vein connector to the renal vein of the kidney, and connecting the output end of the renal artery connector to the renal artery of the kidney; B4: Turn on the first centrifugal pump, the first filter, the first flow rate controller, the first bubble filter, the first bubble detector, the temperature display, and the first renal artery pressure control module, thereby establishing a hypothermic perfusion circuit for the autologous kidney, and the hypothermic perfusion fluid in the blood / perfusion fluid reservoir is transported to the renal artery of the kidney.

10. The method of use according to claim 9, characterized in that: Also included is adjustment of flow rate, temperature and perfusion pressure via a display control panel.

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