A renal perfusion device

Abstract

The application discloses a kidney perfusion device and a use method thereof, and relates to the field of medical devices, and particularly relates to a kidney perfusion device and a use method thereof. The kidney perfusion device comprises a blood / perfusion liquid storage device, a normal temperature / low temperature mode switching module, a normal temperature blood perfusion channel, a low temperature perfusion liquid perfusion channel, a renal artery connector and a renal vein connector. The kidney perfusion device is mainly used for autologous kidney transplantation, and can support normal low temperature perfusion liquid perfusion through a low temperature perfusion channel and also support no ischemia perfusion through a normal temperature perfusion channel. Necessary substances and conditions required for kidney repair are provided through the normal temperature perfusion module, so that the kidney can quickly recover its original function. If no ischemia perfusion cannot be smoothly realized due to limited conditions, or no ischemia perfusion cannot be performed and needs to be stopped, normal low temperature perfusion can be quickly switched to, so as to reduce the risk of thrombosis and improve the survival rate of the kidney.

Description

Technical Field

[0001] This invention belongs to the field of medical devices, specifically relating to a kidney perfusion device and its usage method. Background Technology

[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, flank pain and hematuria syndrome, kidney tumors that are difficult to resect in vivo, and complex retroperitoneal tumors involving the ureter and renal vessels.

[0003] When the aforementioned renal vascular lesions, ureteral lesions, tumors, etc., occur in an anatomical or functional solitary kidney, or when both kidneys are involved simultaneously, autologous kidney transplantation has unique advantages due to its excellent preservation of nephrons and renal function, making it an ideal choice for these patients who absolutely need to preserve their kidneys.

[0004] High-quality donors are fundamental to successful organ transplantation. In conventional autologous kidney transplantation, the blood supply to the renal artery and vein needs to be ligated and severed for cold perfusion before transplantation into the patient's own iliac fossa. The ischemia-reperfusion injury that inevitably occurs during this process can affect kidney function. Therefore, a device that allows for normothermic blood perfusion while the kidney is in the body is needed to reduce ischemia-reperfusion injury. Simultaneously, a cryogenic perfusion mode can be used as a backup when there is no sufficient blood supply from a blood bank or when the patient's financial situation is limited. Summary of the Invention

[0005] This invention aims to at least solve one of the technical problems existing in the prior art. To this end, this invention proposes a renal perfusion device with dual modes of ambient temperature and cryogenic temperature, which can accommodate both ambient temperature blood perfusion and cryogenic perfusion fluid perfusion according to the patient's needs. The ambient temperature perfusion mode can reduce the risk of delayed graft function recovery (DGF), while the cryogenic 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 present invention also proposes a method of using a kidney perfusion device.

[0007] A renal 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 / perfusion fluid reservoir is used to store blood and perfusion fluid separately;

[0009] The input end of the ambient temperature / low temperature mode switching module is connected to the blood / perfusion fluid storage device, the output end of the ambient temperature / low temperature mode switching module is connected to the input end of the ambient temperature blood perfusion pathway, and the output end of the ambient temperature / low temperature mode switching module is simultaneously connected to the input end of the low temperature perfusion fluid perfusion pathway.

[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 also connected to the output end of the low temperature perfusion fluid perfusion pathway. The output end of the renal artery connector is used to communicate with the renal artery of the kidney to infuse 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 cryogenic 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 sequentially connected through a cryogenic perfusion pipeline. The input end of the first filter is connected to the output end of the ambient temperature / cryogenic 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 cryogenic perfusion pathway further includes a temperature display, which 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 ambient temperature 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 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 ambient temperature perfusion pipeline. The input end of the second filter is connected to the output end of the ambient temperature / low temperature mode switching module, and 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 blood oxygen content level, 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, wherein 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 insulation material and a temperature control device, the temperature control device being 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, the urine detector being connected to the kidney.

[0019] The method of using the renal perfusion device according to a second aspect embodiment of the present invention includes a normal temperature perfusion mode and a low temperature perfusion mode;

[0020] The ambient temperature perfusion mode includes the following steps:

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

[0022] A2: Remove the renal artery connector and the renal vein connector for later use;

[0023] A3: Turn on the heating switch of the blood / perfusion fluid storage tank and the second centrifugal pump, and the refrigerated fresh blood in the blood / perfusion fluid storage tank is preheated and transported to the ambient temperature blood perfusion passage;

[0024] A4: After the blood flow stabilizes, turn on 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;

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

[0026] A6: Connect the output end of the renal artery connector to the ligated and severed renal artery of the kidney. This establishes an in-situ, ambient-temperature mechanical perfusion circuit for the kidney, maintaining temperature based on the patient's body temperature. Venous blood from the kidney enters the blood / perfusion fluid reservoir via the renal vein connector. Large impurities are filtered out by a second filter, and the flow rate is controlled by a second flow rate controller. The blood is then oxygenated by an oxygenator, transforming the venous blood into arterial blood. Excess air bubbles are removed by a second bubble filter. A second centrifugal pump provides power to simulate cardiac pulses perfusing the blood. Gases not yet integrated into the blood are filtered out by the second bubble filter, and a second bubble detector confirms the absence of gas. The current blood condition is monitored by a blood oxygen detector and a metabolite detector. The blood pressure is adjusted to a suitable level by the second renal artery pressure control module, delivering arterial blood to the renal artery. This provides blood and nutrients to the kidney during autologous kidney repair, maintaining kidney function.

[0027] The cryogenic perfusion mode includes 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 pre-cooled;

[0029] B2: Switch the ambient / low temperature mode switching module to the low temperature perfusion mode, and confirm that the ambient / low temperature mode switching module is currently connected to the low temperature perfusion fluid perfusion path;

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

[0031] B4: 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 are turned on, thereby establishing a low-temperature perfusion circuit for the autologous kidney, and the low-temperature perfusion fluid in the blood / perfusion fluid reservoir is delivered to the renal artery of the kidney.

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

[0033] The renal perfusion device and its method of use according to embodiments of the present invention have at least the following beneficial effects:

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

[0035] The renal perfusion device of this application supports both cryogenic perfusion with cryogenic perfusion fluid and normothermic perfusion with normothermic blood (i.e., ischemia-free perfusion). By providing the necessary substances and conditions for kidney repair through the normothermic perfusion module, the kidney can quickly restore its original function. If ischemia-free perfusion cannot be successfully achieved due to limitations, or if ischemia-free perfusion cannot be performed and needs to be stopped, it can be quickly switched to conventional cryogenic perfusion, reducing the risk of thrombosis and improving kidney survival rate.

[0036] Compared to traditional organ perfusion devices, this application highly integrates the implementation methods of hypothermic perfusion fluid perfusion and normothermic non-ischemic perfusion transplantation. It functions as an extracorporeal cardiopulmonary bypass after the autologous renal artery and vein are severed, continuously transporting blood to the device for oxygenation and then resupplying it to the abdominal organs in the body to maintain their normal physiological activity. Thus, under the premise of compliance with ethics, it avoids the damage to the donor organ caused by ischemia during surgery, and truly achieves ischemia-free autologous kidney transplantation throughout the entire process.

[0037] 2) The method of using the orthotopic peritoneal organ ambient / low-temperature dual-mode perfusion device based on autologous kidney transplantation in this application includes a temperature-regulating liquid storage device.

[0038] 3) The orthotopic peritoneal organ ambient / hypothermic dual-mode perfusion device based on autologous kidney transplantation proposed in this application uses a centralized control panel for visual adjustment of various parameters.

[0039] Additional aspects and advantages of the invention will be set forth in part in the description which follows, and in part will be obvious from the description, or may be learned by practice of the invention. Attached Figure Description

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

[0041] Figure 1 This is a schematic diagram illustrating the working principle of the kidney perfusion device according to an embodiment of the present invention.

[0042] Figure label:

[0043] Kidney 10;

[0044] Blood / perfusion fluid reservoir 100; ambient temperature / low temperature mode switching module 200; ambient temperature blood perfusion pathway 300; low temperature perfusion fluid perfusion pathway 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] Second filter 301; second flow rate controller 302; oxygenator 303; second bubble filter 304; second centrifugal pump 305; second bubble detector 306; blood oxygen detector 307; metabolite detector 308; second renal artery pressure control module 309. Detailed Implementation

[0047] Embodiments of the present invention are described in detail below. Examples of these embodiments are shown in the accompanying drawings, wherein the same or similar reference numerals denote the same or similar elements or elements having the same or similar functions throughout. The embodiments described below with reference to the accompanying drawings are exemplary and are only used to explain the present invention, and should not be construed as limiting the present invention.

[0048] In the description of this invention, it should be understood that the orientation descriptions, such as up, down, front, back, left, right, etc., are based on the orientation or positional relationship shown in the accompanying drawings. They are only for the convenience of describing this invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limiting this invention.

[0049] In the description of this invention, "several" means one or more, and "multiple" means two or more. The use of "first" and "second" is merely for distinguishing technical features and should not be construed as indicating or implying relative importance, or implicitly indicating the number of indicated technical features, or implicitly indicating the order of the indicated technical features.

[0050] In the description of this invention, "several" means one or more, "more than" means two or more, "greater than," "less than," and "exceeding" are understood to exclude the stated number, while "above," "below," and "within" are understood to include the stated number. The use of "first" and "second" in the description is merely for distinguishing technical features and should not be construed as indicating or implying relative importance, or implicitly indicating the number of indicated technical features, or implicitly indicating the order of the indicated technical features.

[0051] In the description of this invention, unless otherwise explicitly defined, terms such as "set up," "install," and "connect" should be interpreted broadly. Those skilled in the art can reasonably determine the specific meaning of the above terms in this invention in conjunction with the specific content of the technical solution.

[0052] In the description of this invention, references to terms such as "one embodiment," "some embodiments," etc., indicate that a specific feature, structure, material, or characteristic described in connection with that embodiment is included in at least one embodiment of the invention. In this specification, illustrative expressions of the above terms do not necessarily refer to the same embodiment. Furthermore, the specific features, structures, materials, or characteristics described may be combined in any suitable manner in one or more embodiments.

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

[0054] In 1962, the first autologous kidney transplant (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 disease, ureteral disease, and malignant tumors.

[0055] Autologous kidney transplantation is a safe and effective surgical procedure for treating complex renal artery diseases. The major postoperative complication rate is 9.4%, and the autologous transplanted kidney loss rate is 4.1%. The initial arterial patency rate after autologous kidney transplantation for complex renal artery diseases is 90.8%-100%, and the primary arterial patency rate 2-8 years postoperatively is 75%-93%. The cure rate plus remission rate for hypertensive patients after autologous kidney transplantation is 56.3%-61.0%.

[0056] Ureteral injury is a common urinary tract complication during pelvic surgery, with an incidence rate of 1% to 10%. With the widespread use of ureteroscopy, the incidence of ureteral injury has increased, ranging from 0.5% to 10%. Patients with ureteral lesions often undergo multiple medical interventions, especially those with complex ureteral lesions, making the management of ureteral lesions more complex. Besides autologous kidney transplantation and ileal ureteroplasty, surgical options include endoscopic treatment, ureteroureteroanastomosis, ureterovesical reimplantation, Boari bladder flap ureteroplasty, buccal mucosal repair, and appendiceal interposition, depending on the location and length of the ureteral lesion. Autologous kidney transplantation can be considered as an alternative to these surgical methods and is an effective option for upper, long, and complex ureteral lesions.

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

[0058] For localized renal cell carcinoma, radical nephrectomy and partial nephrectomy are both treatment options. Autologous kidney transplantation is indicated for complex renal tumors that are technically not resectable in situ while preserving the organ, such as central renal tumors or tumors involving the renal hilum. Oxford's experience showed a recurrence rate of 5.4% within 10 years after autologous kidney transplantation in 37 patients with T3 stage renal cell carcinoma. The overall graft survival rate and patient survival rate at 10 years post-transplantation for 50 patients were 82% and 75%, respectively.

[0059] When the aforementioned renal vascular lesions, ureteral lesions, tumors, etc. occur in an anatomical or functional solitary kidney, or when both kidneys are involved simultaneously, autologous kidney transplantation has unique advantages due to its excellent preservation of nephrons and renal function, making it an ideal choice for these patients who absolutely need to preserve their kidneys.

[0060] In a conventional autologous kidney transplant, the blood supply to the renal artery and vein needs to be ligated and severed, and cold perfusion is performed before transplantation into the patient's own iliac fossa. The ischemia-reperfusion injury that inevitably occurs during this process can affect kidney function.

[0061] Therefore, a device that allows for normothermic blood perfusion of the kidneys in vivo is needed to reduce renal ischemia-reperfusion injury. Simultaneously, a cryogenic perfusion mode can be used as a backup when there is no sufficient blood supply from a blood bank and when the patient's financial situation is unsuitable.

[0062] Based on this, the present invention provides a kidney perfusion device, the purpose of which is to provide an orthotopic peritoneal organ room temperature / low temperature dual-mode perfusion device based on autologous kidney transplantation, which can take into account both room temperature blood perfusion and low temperature perfusion fluid perfusion according to the patient's needs. Room temperature perfusion can reduce the risk of DGF, while low temperature perfusion is more widely applicable and economical, and at the same time serves as a necessary and timely backup perfusion pathway when performing blood perfusion.

[0063] Reference Figure 1 According to the first aspect of the present invention, the renal perfusion device is an in vivo, uninterrupted blood flow, ambient temperature perfusion device for peritoneal organs based on autologous kidney transplantation. Of course, it is understood that the renal perfusion device can also be used in other situations, and no specific limitations are made herein.

[0064] Reference Figure 1 According to a first aspect of the present invention, a renal perfusion device 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 / perfusion fluid reservoir 100 is used to store blood and perfusion fluid separately. The blood inlet is connected to the blood bag and the blood / perfusion fluid reservoir 100, and the perfusion fluid inlet is connected to the refrigerated transplanted kidney perfusion fluid and the blood / perfusion fluid reservoir 100.

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

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

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

[0069] The renal perfusion device of this application combines the advantages of both cryogenic perfusion and normothermic blood perfusion technologies, and integrates surgical instruments and simplifies surgical procedures as much as possible.

[0070] The renal perfusion device of this application supports both cryogenic perfusion with cryogenic perfusion fluid and normothermic perfusion with normothermic blood (i.e., ischemia-free perfusion). By providing the necessary substances and conditions for kidney 10 repair through the normothermic perfusion module, the kidney 10 can quickly restore its original function. If ischemia-free perfusion cannot be successfully achieved due to limitations, or if ischemia-free perfusion cannot be performed and needs to be stopped, it can be quickly switched to conventional cryogenic perfusion, reducing the risk of thrombosis and improving the survival rate of kidney 10.

[0071] Compared to traditional organ perfusion devices, this application highly integrates the implementation methods of hypothermic perfusion fluid perfusion and normothermic ischemia-free perfusion transplantation. It functions as an extracorporeal cardiopulmonary bypass after the autologous renal artery and vein are severed, continuously transporting blood to the device for oxygenation and then resupplying it to the abdominal organs in the body to maintain their normal physiological activity. Thus, under ethical conditions, it avoids damage to the donor organ caused by ischemia during surgery, truly achieving ischemia-free autologous kidney transplantation throughout the entire process.

[0072] Reference Figure 1 In some embodiments of the present invention, the cryogenic perfusion fluid infusion 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 sequentially connected through a cryogenic perfusion pipeline. The input end of the first filter 410 is connected to the output end of the ambient temperature / cryogenic 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 cryogenic perfusion pathway 400 is used for cryogenic routine perfusion of the kidney 10. A first filter 410, connected to a room temperature / cryo-temperature mode switching module 200, filters visible impurities from the perfusion fluid flowing in from the blood / perfusion fluid reservoir 100. A first flow rate controller 420, located on the cryogenic perfusion line between the first filter 410 and the first bubble filter 430, controls the flow rate of the perfusion fluid, thereby affecting the perfusion pressure. The first bubble filter 430, located on the perfusion line between the first flow rate controller 420 and the first centrifugal pump 440, filters out air bubbles in the perfusion fluid. The first centrifugal pump 440, located on the room temperature perfusion pathway between the first bubble filter 430 and the first renal artery pressure control module 470, provides power to the cryogenic perfusion fluid. The first renal artery pressure control module 470, connected to the renal artery connector 500, supplies appropriately pressurized, bubble-free cryogenic perfusion fluid to the renal artery.

[0074] Reference Figure 1 In some embodiments of the present invention, the low-temperature perfusion fluid infusion 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 ambient temperature 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 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 a 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. 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 content venous blood into high oxygen content arterial blood. The blood oxygen detector 307 is used to detect the blood oxygen content level. The metabolite detector 308 is used to detect the level of metabolic waste in the blood.

[0076] A normothermic blood perfusion pathway 300 is used for normothermic non-ischemic perfusion of the kidney 10. A second filter 301 is located in the normothermic perfusion conduit between the blood / perfusion fluid reservoir 100 and the second flow rate controller 302, used to filter out larger impurities in the blood while minimizing damage to blood cells. The second flow rate controller 302 is located in the normothermic perfusion conduit between the second flow rate controller 302 and the oxygenator 303, used to control the blood flow rate. The oxygenator 303 is located in the normothermic perfusion conduit between the second flow rate controller 302 and the second bubble filter 304, used to adequately oxygenate low-oxygen venous blood into high-oxygen arterial blood. The second bubble filter 304 is located in the normothermic perfusion conduit between the oxygenator 303 and the second centrifugal pump 305, used to filter out insoluble gases or free oxygen not bound to hemoglobin in the blood. The second centrifugal pump 305 is located in the ambient temperature perfusion pathway 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 in the ambient temperature perfusion pathway 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 in the ambient temperature perfusion pathway between the second bubble detector 306 and the metabolite detector 308, and is used to detect the blood oxygen content level. The metabolite detector 308 is located in the ambient temperature perfusion pathway between the blood oxygen detector 307 and the second renal artery pressure control module 309, and is used to detect the levels of metabolic waste products such as urea and creatinine in the blood. The second renal artery pressure control module 309 connects the metabolite detector 308 and the renal artery connector 500, and controls 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. 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. 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 / perfusion fluid reservoir 100 includes multiple layers of insulation material and a temperature control device. The temperature control device is electrically connected to the display control panel 700 to control the working state of the temperature control device and the temperature parameters of the blood and perfusion fluid in the blood / perfusion fluid 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 perfusion fluid in the blood / perfusion fluid reservoir 100 reach a set temperature.

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

[0081] This application supports both conventional perfusion via a cryogenic perfusion pathway and ischemia-free perfusion via a blood perfusion pathway. The normothermic perfusion module provides the necessary substances and conditions for kidney 10 repair, enabling kidney 10 to quickly restore its original function. If ischemia-free perfusion cannot be successfully achieved due to limitations, or if ischemia-free perfusion needs to be stopped, it can be quickly switched to conventional cryogenic perfusion, reducing the risk of thrombosis and improving kidney 10 survival rate.

[0082] The method of using the renal perfusion device according to a second aspect embodiment of the present invention includes a normal temperature perfusion mode and a low temperature perfusion mode;

[0083] The ambient temperature infusion mode includes the following steps:

[0084] A1: Switch the room temperature / low temperature mode switching module 200 to room temperature perfusion mode, and confirm that the room temperature / low temperature mode switching module 200 is now connected to the room temperature blood perfusion pathway 300;

[0085] A2: Remove the renal artery connector 500 and the renal vein connector 600 for later use;

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

[0087] A4: After the blood flow stabilizes, turn on 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.

[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: Connect the output end of the renal artery connector 500 to the ligated and severed renal artery of the kidney 10. This establishes an in-situ, ambient-temperature mechanical perfusion circuit for the kidney 10, maintaining its temperature based on the patient's body temperature. Venous blood from the kidney 10 enters the blood / perfusion fluid reservoir 100 via the renal vein connector 600, where large impurities are filtered by the second filter 301, the flow rate is controlled by the second flow rate controller 302, and oxygenation is performed by the oxygenator 303, converting the venous blood into arterial blood. Excess blood is then filtered out by the second bubble filter 304. The bubbles are then powered by a second centrifugal pump 305 to simulate the heartbeat perfusion of blood. The gas that has not yet been incorporated into the blood is filtered out by a second bubble filter 304, and the second bubble detector 306 confirms that no gas remains. The current blood condition is detected by a blood oxygen detector 307 and a metabolite detector 308. The blood pressure is adjusted to a suitable level by a second renal artery pressure control module 309, and arterial blood is delivered to the artery of the kidney 10. This provides blood and nutrients to the kidney 10 during the autologous kidney repair period, maintaining the function of the kidney 10.

[0090] The cryogenic infusion mode includes the following steps:

[0091] B1: Turn on the cooling switch of the blood / perfusion fluid reservoir 100, and the perfusion fluid in the blood / perfusion fluid reservoir 100 is pre-cooled;

[0092] B2: Switch the ambient / low temperature mode switching module 200 to the low temperature perfusion mode, and confirm that the ambient / low temperature mode switching module 200 is currently connected to the low temperature perfusion fluid perfusion passage 400;

[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: 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 are turned on, thereby establishing the low-temperature perfusion circuit of the autologous kidney 10, and the low-temperature perfusion fluid in the blood / perfusion fluid reservoir 100 is delivered to the renal artery of the kidney 10.

[0095] Example 1

[0096] This embodiment uses an orthotopic peritoneal organ normothermic / hypothermic dual-mode perfusion device based on autologous kidney transplantation to perform ischemia-free normothermic perfusion and autologous kidney transplantation on the patient. The specific process is as follows:

[0097] Switch the renal artery circulation module to ambient temperature perfusion mode. After confirming that the pathway selection is correct, remove the arterial and venous connection ends for later use. Turn on the heating switch of the blood / perfusion fluid storage tank 100 to preheat it. Input refrigerated fresh blood into the fluid pathway and turn on the second centrifugal pump 305 to start the ambient temperature perfusion pathway.

[0098] After the above operations are completed and confirmed to be correct, and after blood flow has stabilized, turn on the following detection and control switches: second filter 301, second flow rate controller 302, oxygenator 303, second bubble filter 304, second centrifugal pump 305, second bubble filter 304, second bubble detector 306, blood oxygen detector 307, metabolite detector 308, and second renal artery pressure control module 309. Ensure that each component is working properly and operating normally.

[0099] Autologous kidney 10 removal surgery (taking the removal of the right kidney 10 in a case of renal artery stenosis as an example): After successful endotracheal anesthesia, the patient is placed in a supine position, 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 to enter the abdomen and expose the right renal vein and right renal artery. The renal fascia is opened, the peritoneum is pushed forward to expose the right kidney, and the ureter is located in front of the psoas major muscle. The ureter is lifted with a vascular sling and dissected downwards to near the pelvis. The perirenal fat is freed outside the renal tunica propria, and the adrenal gland is dissected above the kidney. The left renal vein is dissected, and its tributaries, such as the genital vein, are ligated and cut. The renal vein is ligated and cut with No. 7 silk suture. The renal vein connector is connected to the renal vein and fixed, and the distal end of the renal vein connector is blocked with a clamp to prevent portal vein blood outflow. The proximal end of the left renal artery is exposed between the inferior vena cava and the abdominal aorta, ligated and cut with No. 7 silk suture, and the renal artery connector 500 is connected to the proximal end of the renal artery and properly fixed. A ureter is connected to a urine collection device. This establishes an in-situ, normothermic mechanical perfusion circuit for the autologous kidney 10, maintaining temperature based on the patient's body temperature.

[0100] After the renal vein connector 500 is connected to the renal vein and the renal artery connector 500, venous blood enters the blood / perfusion fluid reservoir 100 through the blood input end. Large impurities are filtered out by the second filter 301, and the flow rate is controlled by the second flow rate controller 302. Then, oxygenation is performed by the oxygenator 303, turning the venous blood into arterial blood. Excess bubbles are filtered out by the second bubble filter 304, and then the second centrifugal pump 305 provides power to simulate cardiac pulse perfusion of blood. Gases that have not yet been incorporated into the blood are filtered out by the second bubble filter 304, and the second bubble detector 306 confirms that no gas remains. The current blood condition is detected by the blood oxygen detector 307 and the metabolite detector 308. The blood pressure is adjusted to a suitable level by the second renal artery pressure control module 309, and the arterial blood is delivered to the donor artery. The arterial blood flows into the kidney 10 in the donor body, thus providing blood, nutrients, and other support to the kidney 10 during the autologous kidney repair period to maintain the function of the kidney 10.

[0101] Autologous kidney resection: The kidney 10 is kept in its original position. Its color and texture are examined to confirm the absence of deformities or damage. Surrounding tissue is removed along the renal artery, and the kidney is freed to approximately 2 cm from the renal hilum. The ureter is then resectioned distally, preserving an appropriate amount of surrounding tissue, including the adipose tissue and mesangium surrounding the lower ureter. Throughout this procedure, the kidney 10 is kept adequately perfused with blood.

[0102] Autologous Kidney 10 Implantation Surgery: The right internal iliac artery and right common iliac vein were fully dissected. Without interrupting perfusion, the kidney 10, along with the perfusion tubing, was transposed into the right iliac fossa. A 6-0 Prolene suture was used for end-to-side anastomosis of the renal vein and right common iliac vein; a 8-0 Prolene suture was used for end-to-side anastomosis of the renal artery and right internal iliac artery. Throughout the vascular anastomosis process, continuous normothermic mechanical perfusion was maintained to ensure uninterrupted blood flow to the donor liver's portal vein and hepatic artery. The autologous kidney's renal vein and renal artery were anastomosed end-to-side to the right external iliac vein and the right external iliac artery, respectively. The abdominal cavity was cleaned, hemostasis was achieved, and drainage tubes were placed before the abdomen was closed. Throughout this process, uninterrupted blood flow was maintained to the kidney 10.

[0103] Thus, throughout the four processes—in-situ normothermic perfusion, autologous kidney 10 retrieval surgery, ischemia-free autologous kidney repair surgery, and ischemia-free autologous kidney implantation surgery—the autologous kidney 10 maintains uninterrupted blood flow, completely avoiding ischemia-reperfusion injury, thereby achieving the best transplantation efficacy.

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

[0105] Example 2

[0106] This embodiment uses an orthotopic peritoneal organ ambient / cold dual-mode perfusion device based on autologous kidney transplantation to perform ischemia-free ambient perfusion and transplantation on patients. When ischemia-free perfusion cannot proceed normally, it is rapidly switched to cryogenic perfusion. The specific process is as follows:

[0107] The procedures for obtaining an autologous transplanted kidney, connecting the renal vein connector to the renal vein, and connecting the renal artery connector 500 to the renal artery are the same as in Example 1.

[0108] After a period of in vivo perfusion via normothermic perfusion support pathway, the pathway became unable to function properly for some reason, and it was decided to terminate the ischemia-free normothermic perfusion.

[0109] Pre-cool the blood / perfusion fluid reservoir 100 by turning on the cooling switch. Disconnect the renal vein connection from the renal vein, stopping the flow of blood from the blood inlet to the pathway. Introduce the refrigerated renal perfusion fluid into the fluid pathway through the perfusion fluid inlet. At this time, the renal artery connector 500 is still connected to the normal temperature perfusion pathway. After visually observing that the fluid in this pathway changes from red to clear, switch the renal artery circulation module to the low-temperature perfusion mode. After confirming that the pathway has been changed correctly, turn on the first centrifugal pump 440 to start the low-temperature perfusion pathway. Simultaneously turn on all detection and control switches, 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 all parts are working properly and operating normally.

[0110] The first filter is connected to the blood / perfusion fluid reservoir 100 for storing the perfusion fluid. Impurities in the fluid are removed by the first filter. The flow rate is then controlled by the first flow rate controller 420. After air bubbles are removed by the first bubble filter 430, the current temperature of the perfusion fluid is displayed. The pressure is adjusted by the first renal artery pressure control module 470, and the fluid is then connected to the kidney 10 via the renal artery connector for perfusion. During this process, the flow rate, temperature, and perfusion pressure can be adjusted via the display control panel 700.

[0111] The renal perfusion device of this application combines the advantages of both cryogenic perfusion and normothermic blood perfusion technologies, and integrates surgical instruments and simplifies surgical procedures as much as possible.

[0112] The renal perfusion device of this application supports both cryogenic perfusion with cryogenic perfusion fluid and normothermic perfusion with normothermic blood (i.e., ischemia-free perfusion). By providing the necessary substances and conditions for kidney repair through the normothermic perfusion module, the kidney can quickly restore its original function. If ischemia-free perfusion cannot be successfully achieved due to limitations, or if ischemia-free perfusion cannot be performed and needs to be stopped, it can be quickly switched to conventional cryogenic perfusion, reducing the risk of thrombosis and improving kidney survival rate.

[0113] Compared to traditional organ perfusion devices, this application highly integrates the implementation methods of hypothermic perfusion fluid perfusion and normothermic ischemia-free perfusion transplantation. It functions as an extracorporeal cardiopulmonary bypass after the autologous renal artery and vein are severed, continuously transporting blood to the device for oxygenation and then resupplying it to the abdominal organs in the body to maintain their normal physiological activity. Thus, under ethical conditions, it avoids damage to the donor organ caused by ischemia during surgery, truly achieving ischemia-free autologous kidney transplantation throughout the entire process.

[0114] The method of using the orthotopic peritoneal organ ambient / hypothermal dual-mode perfusion device based on autologous kidney transplantation in this application includes a temperature-regulating liquid storage device.

[0115] The orthotopic peritoneal organ ambient / hypothermic dual-mode perfusion device based on autologous kidney transplantation proposed in this application uses a centralized control panel for visual adjustment of various parameters.

[0116] The above-described embodiments are only used to illustrate the technical solutions of this application, and are not intended to limit them. Although this application has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some of the technical features. Such modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the embodiments of this application.

[0117] The technical features of the above embodiments can be combined in any way. For the sake of brevity, not all possible combinations of the technical features in the above 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 invention has been described in detail above with reference to the accompanying drawings. However, the present invention is not limited to the above embodiments. Within the scope of knowledge possessed by those skilled in the art, various changes can be made without departing from the spirit of the invention.

Claims

1. A renal perfusion device, characterized in that, Includes a blood / perfusion fluid reservoir, a room temperature / low temperature mode switching module, a room temperature blood perfusion pathway, a low temperature perfusion fluid perfusion pathway, a renal artery connector, and a renal vein connector; The blood / perfusion fluid reservoir is used to store blood and perfusion fluid separately; The input end of the ambient temperature / low temperature mode switching module is connected to the blood / perfusion fluid storage device, the output end of the ambient temperature / low temperature mode switching module is connected to the input end of the ambient temperature blood perfusion pathway, and the output end of the ambient temperature / low temperature mode switching module is simultaneously connected to the input end of the low temperature perfusion fluid perfusion pathway. 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 also connected to the output end of the low temperature perfusion fluid perfusion pathway. The output end of the renal artery connector is used to communicate with the renal artery of the kidney to infuse 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; The cryogenic 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 sequentially connected through a cryogenic perfusion pipeline. The input end of the first filter is connected to the output end of the ambient temperature / cryogenic 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. The cryogenic perfusion pathway also includes a temperature display, which is located between the first bubble detector and the first renal artery pressure control module; The ambient temperature 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 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 an ambient temperature perfusion pipeline. The input end of the second filter is connected to the output end of the ambient temperature / low temperature mode switching module, and 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 blood oxygen content level, and the metabolite detector is used to detect the level of metabolic waste in the blood.

2. The renal perfusion device according to claim 1, characterized in that, It also includes a display control panel, wherein 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.

3. The renal perfusion device according to claim 2, characterized in that, The blood / perfusion fluid reservoir includes multiple layers of insulation material and a temperature control device, which is electrically connected to the display control panel.

4. The renal perfusion device according to claim 3, characterized in that, The temperature control device includes a heating element, a cooling element, a heating switch, and a cooling switch.

5. The renal perfusion device according to claim 4, characterized in that, It also includes a urine detector, which is connected to the kidney.

6. A method of using the renal perfusion device according to claim 4 or 5, characterized in that, Including normal temperature perfusion mode and low temperature perfusion mode; The ambient temperature perfusion mode includes the following steps: A1: Switch the ambient temperature / low temperature mode switching module to ambient temperature perfusion mode, and confirm that the ambient temperature / low temperature mode switching module is currently connected to the ambient temperature blood perfusion pathway; A2: Remove the renal artery connector and the renal vein connector for later use; A3: Turn on the heating switch of the blood / perfusion fluid storage tank and the second centrifugal pump, and the refrigerated fresh blood in the blood / perfusion fluid storage tank is preheated and transported to the ambient temperature blood perfusion passage; A4: After the blood flow stabilizes, turn on 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; A5: Connect the input end of the renal vein connector to the ligated and severed renal vein of the kidney; A6: Connect the output end of the renal artery connector to the ligated and severed renal artery of the kidney. This establishes an in-situ, ambient-temperature mechanical perfusion circuit for the kidney, maintaining temperature based on the patient's body temperature. Venous blood from the kidney enters the blood / perfusion fluid reservoir via the renal vein connector. Large impurities are filtered out by a second filter, and the flow rate is controlled by a second flow rate controller. The blood is then oxygenated by an oxygenator, transforming the venous blood into arterial blood. Excess air bubbles are removed by a second bubble filter. A second centrifugal pump provides power to simulate cardiac pulses perfusing the blood. Gases not yet integrated into the blood are filtered out by the second bubble filter, and a second bubble detector confirms the absence of gas. The current blood condition is monitored by a blood oxygen detector and a metabolite detector. The blood pressure is adjusted to a suitable level by the second renal artery pressure control module, delivering arterial blood to the renal artery. This provides blood and nutrients to the kidney during autologous kidney repair, maintaining kidney function. The cryogenic perfusion mode includes 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 pre-cooled; B2: Switch the ambient / low temperature mode switching module to the low temperature perfusion mode, and confirm that the ambient / low temperature mode switching module is currently connected to the low temperature perfusion fluid perfusion path; B3: Connect the input end of the renal vein connector to the renal vein of the kidney, and connect the output end of the renal artery connector to the renal artery of the kidney; B4: 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 are turned on, thereby establishing a low-temperature perfusion circuit for the autologous kidney, and the low-temperature perfusion fluid in the blood / perfusion fluid reservoir is delivered to the renal artery of the kidney.

7. The method of use according to claim 6, characterized in that, It also includes the ability to adjust flow rate, temperature, and injection pressure via a display control panel.

Images