A device and method and method for occluding a conduit for blood purification therapy during non-treatment periods

Abstract

This application provides an apparatus and method for sealing a blood purification catheter during non-treatment periods, relating to the field of smart healthcare. The apparatus includes: a Y-tube pressure measurement module for matching and connecting the arterial and venous branches of the blood filtration catheter, and for measuring the pressure within the arterial and venous branches; the Y-tube pressure measurement module includes an arterial branch for matching and connecting the arterial branch, a venous branch for matching and connecting the blood filtration branch, and pressure sensors respectively disposed on the walls of the arterial and venous branches, the pressure sensors being used to measure intravascular pressure; and an anticoagulant drug delivery module including an anticoagulant drug and a pressure structure that continuously acts on the anticoagulant drug, the pressure structure pressurizing the anticoagulant drug and providing a preset pressure so that the anticoagulant drug enters the blood vessel at a preset rate.

Description

Technical Field

[0001] This invention relates to the field of intelligent medical care, and more specifically, to an apparatus and method for sealing a blood purification treatment catheter during non-treatment periods. Background Technology

[0002] Currently, the temporary or long-term central venous catheters (hereinafter referred to as dialysis / hemofiltration catheters) used in clinical blood purification treatments, including hemodialysis and hemofiltration (CRRT), are double-lumen tubes with an arterial end and a venous end, which draw blood out / return blood to the body during dialysis or hemofiltration, respectively.

[0003] However, during the non-treatment period between the end of one treatment and the start of the next (the treatment interval), it is clinically necessary to seal the hemofiltration catheter to prevent in-catheter thrombosis. Currently, the routine clinical procedure involves sealing with anticoagulants or thrombolytic drugs, such as high-concentration heparin solution. However, because the drug gradually diffuses into the bloodstream through the catheter opening, this method still carries a significant risk of in-catheter or peri-catheter thrombosis. Commonly used high-concentration heparin, or even pure heparin, can affect the patient's coagulation function, especially in patients with pre-existing coagulation disorders, greatly increasing the risk of bleeding. Even for patients with normal or excessively strong coagulation function, a 2-3 day sealing interval can easily lead to in-catheter or peri-catheter thrombosis, affecting catheter lifespan. Furthermore, thrombosis can easily lead to infection, which can be life-threatening in severe cases. Especially for critically ill patients, blood purification therapy is closely related to patient prognosis. However, the central vein into which dialysis / hemofiltration catheters can be inserted is already limited. At the same time, patients often have coagulation abnormalities. Traditional catheter sealing methods cannot guarantee catheter patency and are prone to complications such as thrombosis, infection, and bleeding, so improvements are urgently needed. Summary of the Invention

[0004] The present invention aims to at least solve one of the technical problems existing in the prior art. To this end, the present invention provides an apparatus and method for sealing a blood purification treatment catheter during non-treatment periods; the apparatus and method of the present invention can significantly reduce the incidence of thrombosis and infection in dialysis / hemofiltration catheters, while also reducing the occurrence of coagulation dysfunction and the risk of bleeding.

[0005] The first aspect of this application discloses a device and method for sealing a blood purification catheter during non-treatment periods. This method is applicable to central venous catheters used in blood purification treatments including hemodialysis and hemofiltration. The central venous catheter includes a dialysis / hemofiltration catheter, which includes an arterial branch for draining blood and a venous branch for returning blood after blood purification treatment to the patient. The device is suitable for maintaining catheter patency during the hemofiltration interval between the end of one dialysis treatment and the start of the next treatment, preventing thrombosis within and around the catheter, thereby extending the catheter's lifespan. The device includes: The Y-tube pressure measurement module is used to match and connect the arterial branch and venous branch of the blood filtration catheter, and can be used to measure the pressure in the arterial branch and venous branch. The Y-tube pressure measurement module includes an arterial branch for matching and connecting the arterial branch, a venous branch for matching and connecting the venous branch, and pressure sensors respectively disposed on the walls of the arterial branch and the venous branch. The pressure sensors are used to measure the pressure inside the blood vessel. An anticoagulant delivery module includes an anticoagulant and a pressure structure that continuously acts on the anticoagulant and applies pressure, wherein the pressure structure pressurizes the anticoagulant and provides a preset pressure so that the anticoagulant enters the blood vessel at a preset rate.

[0006] In some embodiments, the preset pressure value is a range including an upper pressure threshold and a lower pressure threshold. When the catheter length is less than a preset threshold, a lower pressure is required. The preset pressure value is selected from a first threshold range. When the catheter length is greater than or equal to a preset threshold, a higher pressure is required, and the preset pressure value is selected from the second threshold range.

[0007] In some embodiments, the first threshold range is 100-200 mmHg, preferably 150 mmHg.

[0008] In some embodiments, the second threshold range is 250-350 Hg, preferably 300 mmHg.

[0009] In some embodiments, the preset speed range includes 1-3 ml / h to prevent pipeline blockage.

[0010] In some embodiments, the pressure structure includes: a pressurized infusion device including a pressure bag, and an adjustable-speed intravenous infusion pump including a micro-pump.

[0011] In some embodiments, the anticoagulant includes any one or more of the following: diluted unfractionated heparin saline solution, sodium citrate solution, nemostat solution, and fondaparinux sodium solution.

[0012] A second aspect of this application discloses a method for closing a catheter during non-treatment periods, wherein the following method is performed using the apparatus described in the first aspect of this application, the method comprising: The arterial branch is connected to the arterial branch tube, and the venous branch is connected to the venous branch tube; The pressure structure is activated, and the pressure delivered by the pressure structure is used to continuously inject the anticoagulant drug into the arterial branch at a preset speed through the arterial branch, and to continuously inject the anticoagulant drug into the venous branch at a preset speed through the venous branch.

[0013] In some embodiments, the pressure structure includes: a pressurized infusion device including a pressure bag, and an adjustable-speed intravenous infusion pump including a micro-pump.

[0014] In some embodiments, the method further includes receiving real-time pressure values ​​of arterial and venous branches acquired by the pressure sensor.

[0015] This application has the following beneficial effects: This application innovatively discloses a device and method for sealing dialysis / hemofiltration catheters during non-treatment periods. Unlike existing methods that use a "blocking" approach, this device and method attempt to use a "clearing" approach to seal the catheter, aiming to prevent thrombus formation within the catheter and around its tip. Comparative data between this method and commonly used clinical "blocking" methods for catheter sealing are shown in Table 1. Table 1. Comparative data between continuous infusion method and traditional single-use catheter sealing method

[0016] Furthermore, the "unblocking" method described in this application utilizes a pressure device to continuously pass the anticoagulant solution through the catheter and into the patient's blood vessels. Because the pressure inside the catheter is higher than the pressure inside the blood vessel, blood will not enter the catheter, thus preventing thrombus formation. Simultaneously, the continuous flow of anticoagulant through the catheter tip into the blood vessel ensures a constant presence of anticoagulant around the catheter, further reducing the probability of pericatheter thrombosis. This significantly extends the lifespan of dialysis / hemofiltration catheters.

[0017] Furthermore, because the delivery of anticoagulants involves a very slow infusion of small amounts of diluted unfractionated heparin, sodium citrate solution, or other low-concentration anticoagulants, it has virtually no impact on the patient's coagulation function. This method significantly reduces catheter-related adverse events in medical settings, especially for critically ill patients, and substantially lowers the risk of bleeding, thrombosis, infection, and coagulation disorders. Moreover, this device and method are simple and easy to implement, and can be directly connected to existing dialysis / hemofiltration catheters. Attached Figure Description

[0018] To more clearly illustrate the technical solutions in the embodiments of the present invention, the accompanying drawings used in the description of the embodiments will be briefly introduced below. Obviously, the accompanying drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0019] Figure 1 This is a schematic flowchart of a method for closing a catheter during non-treatment periods provided by an embodiment of the present invention; Figure 2 This is a schematic diagram of a system for sealing catheters during non-treatment periods provided in an embodiment of the present invention; Figure 3 These are comparative images showing the results of using the sealing method of this application and a traditional sealing method to treat the catheter before blood purification treatment. The images show the operator routinely aspirating 5ml of blood from the dialysis / hemofiltration catheter and injecting it onto gauze. Figure 3 In case A, the catheter was treated using the continuous infusion of low-concentration heparin solution locking method of this application, and no thrombus was observed. Figure 3 B in this case involved a single-use sealing method using a traditional high-concentration heparin solution, which resulted in a large thrombus. Detailed Implementation

[0020] To enable those skilled in the art to better understand the present invention, the technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings.

[0021] In some of the processes described in the specification, claims, and accompanying drawings of this invention, multiple operations appearing in a specific order are included. However, it should be clearly understood that these operations may not be executed in the order they appear herein, or may be executed in parallel. The operation numbers, such as 101, 102, etc., are merely used to distinguish different operations and do not represent any execution order. Furthermore, these processes may include more or fewer operations, and these operations may be executed sequentially or in parallel. It should be noted that the descriptions such as "first," "second," etc., in this document are used to distinguish different messages, devices, modules, etc., and do not represent a sequential order, nor do they limit "first" and "second" to different types.

[0022] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0023] Figure 1 This is a schematic flowchart of a method for closing a catheter during non-treatment periods according to an embodiment of the present invention. Specifically, the method is performed using a device and method for closing a blood purification treatment catheter during non-treatment periods. The device is applicable to central venous catheters used in blood purification treatments including hemodialysis and hemofiltration. The central venous catheter includes a dialysis / hemofiltration catheter, which includes an arterial branch for draining blood and a venous branch for returning blood after blood purification treatment to the patient. The device is suitable for the hemofiltration interval between the end of one dialysis treatment and the start of the next treatment in blood purification treatment, to maintain catheter patency, avoid thrombus formation within and around the catheter, thereby extending the catheter's lifespan. The device includes: The Y-tube pressure measurement module is used to match and connect the arterial and venous branches of the hemofiltration catheter, and to measure the pressure within the arterial and venous branches. The Y-tube pressure measurement module includes an arterial branch for matching and connecting the arterial branch, a venous branch for matching and connecting the venous branch, and pressure sensors respectively disposed on the walls of the arterial and venous branches. The pressure sensors are used to measure the pressure within the blood vessels. Each arterial and venous branch has a free port, which matches the diameter of the arterial and venous branches respectively, and can be directly connected.

[0024] In some embodiments, the connection method between the pressure sensor and the catheter is not limited and is designed according to standard clinical methods. Currently, the mainstream clinical approach is to monitor pressure by connecting an external pressure sensor to the extracorporeal circulation tubing. However, there are also catheter-embedded sensors, whose connection methods to the catheter wall mainly include: tip-embedded, wall-embedded / side-hole type.

[0025] An anticoagulant delivery module includes an anticoagulant and a pressure structure that continuously acts on the anticoagulant and applies pressure, wherein the pressure structure pressurizes the anticoagulant and provides a preset pressure so that the anticoagulant enters the blood vessel at a preset rate.

[0026] In some embodiments, dialysis / hemofiltration catheters are temporary or long-term central venous catheters used in clinical blood purification treatments including hemodialysis and hemofiltration (CRRT). Temporary and long-term catheters are classified and named according to the duration of implantation. Temporary catheters are technically called temporary central venous catheters, characterized by the absence of a subcutaneous tunnel and direct insertion, typically used for short-term treatments (such as acute kidney injury or CRRT). Long-term catheters are technically called tunneled cuffed catheters (TCC), characterized by a polyester cuff at the catheter tip embedded in a subcutaneous tunnel, used to establish long-term stable vascular access.

[0027] In some more specific embodiments, the preset pressure value is a range that includes an upper pressure threshold and a lower pressure threshold. When the catheter length is less than a preset threshold, a lower pressure is required, and the preset pressure value is selected from a first threshold range. When the catheter length is greater than or equal to the preset threshold, a higher pressure is required, and the preset pressure value is selected from a second threshold range. The preset threshold for length is determined based on clinical experience and is not specifically limited in this embodiment. Generally, those skilled in the art will know that shorter catheter lengths require lower pressure, and longer catheter lengths require higher pressure.

[0028] In some embodiments, the first threshold range is 100-200 mmHg, preferably 150 mmHg.

[0029] In some embodiments, the second threshold range is 250-350 Hg, preferably 300 mmHg.

[0030] In some more specific embodiments, the preset speed range includes 1-3 ml / h to prevent tubing blockage.

[0031] In some embodiments, the pressure structure includes: a pressurized infusion device including a pressure bag, and an adjustable-speed intravenous infusion pump including a micro-pump.

[0032] In some embodiments, hospitalized patients can use pressure bags directly. For patients who can go home after treatment, using a set of pressure bags is not convenient. Therefore, the pressure bags are replaced with an adjustable-speed intravenous infusion pump that includes a micro-pump. The infusion pump can be designed in a miniature version that can be placed in a pocket.

[0033] In some embodiments, the anticoagulant includes: diluted unfractionated heparin saline solution, sodium citrate solution, nemostat solution, and fondaparinux sodium solution. In this embodiment, because the concentration of the injected anticoagulant is very low and the total amount entering the body is minimal, it will not affect the patient's coagulation function.

[0034] Specifically, the method performed using the device and method for closing the catheter during non-treatment periods in blood purification therapy includes the following steps: S101: Connect the arterial branch to the arterial tube, and connect the venous branch to the venous tube; S102: Activate the pressure structure, and use the pressure delivered by the pressure structure to continuously inject the anticoagulant drug into the arterial branch at a preset speed through the arterial branch, and continuously inject the anticoagulant drug into the venous branch at a preset speed through the venous branch. This disclosure also provides a system for closing catheters during non-treatment periods, such as... Figure 2As shown, the system includes: The catheter connection module 201 is used or configured to connect the arterial branch to the arterial branch tube and the venous branch to the venous branch tube; The drug delivery module 202 is used or configured to activate the pressure structure, using the pressure delivered by the pressure structure to continuously inject the anticoagulant drug into the arterial branch at a preset speed through the arterial branch, and to continuously inject the anticoagulant drug into the venous branch at a preset speed through the venous branch. Those skilled in the art will clearly understand that, for the sake of convenience and brevity, the specific working processes of the systems, devices, and units described above can be referred to the corresponding processes in the foregoing method embodiments, and will not be repeated here.

[0035] The exemplary embodiments of this disclosure described in detail above are merely illustrative and not restrictive. Those skilled in the art will understand that various modifications and combinations can be made to these embodiments or their features without departing from the principles and spirit of this disclosure, and such modifications should fall within the scope of this disclosure.

Claims

1. A device for closing a blood purification treatment catheter during non-treatment periods, applicable to central venous catheters used for blood purification treatment, the central venous catheter comprising a dialysis / hemofiltration catheter, said dialysis / hemofiltration catheter comprising an arterial branch for draining blood and a venous branch for returning treated blood to the body, characterized in that, The device is suitable for the hemofiltration interval between the end of the previous dialysis treatment and the start of the next treatment, in order to maintain catheter patency, avoid thrombosis within and around the catheter, and thus extend the lifespan of the catheter. The device includes: The Y-tube pressure measurement module is used to match and connect the arterial branch and venous branch of the blood filtration catheter, and to measure the pressure in the arterial branch and venous branch. The Y-tube pressure measurement module includes an arterial branch for matching and connecting the arterial branch, a venous branch for matching and connecting the venous branch, and pressure sensors respectively disposed on the walls of the arterial branch and the venous branch. The pressure sensors are used to measure the pressure inside the blood vessel. An anticoagulant delivery module includes an anticoagulant and a pressure structure that continuously acts on the anticoagulant and applies pressure, wherein the pressure structure pressurizes the anticoagulant and provides a preset pressure so that the anticoagulant enters the blood vessel at a preset rate.

2. The device for sealing the blood purification treatment catheter during non-treatment periods according to claim 1, characterized in that, The preset pressure value is a range that includes an upper pressure threshold and a lower pressure threshold. When the catheter length is less than a preset threshold, the preset pressure value is selected from the first threshold range. When the catheter length is greater than or equal to a preset threshold, the preset pressure value is selected from the second threshold range.

3. The device for sealing the blood purification treatment catheter during non-treatment periods according to claim 2, characterized in that, The first threshold range is 100-200 mmHg, preferably 150 mmHg.

4. The device for sealing the blood purification treatment catheter during non-treatment periods according to claim 2, characterized in that, The second threshold range is 250-350 mmHg, preferably 300 mmHg.

5. The device for sealing the blood purification treatment catheter during non-treatment periods according to claim 1, characterized in that, The preset speed range includes 1-3 ml / h.

6. The device for sealing the blood purification treatment catheter during non-treatment periods according to claim 1, characterized in that, The pressure structure includes: a pressurized infusion device including a pressure bag, and an adjustable-speed intravenous infusion pump including a micro-pump.

7. The device for sealing the blood purification treatment catheter during non-treatment periods according to claim 1, characterized in that, The anticoagulant includes one or more of the following: unfractionated heparin saline solution, sodium citrate solution, nemostat solution, and fondaparinux sodium solution.

8. A method for closing a blood purification treatment catheter during non-treatment periods, characterized in that, The following method is performed using the apparatus according to any one of claims 1-7, the method comprising: The arterial branch is connected to the arterial branch tube, and the venous branch is connected to the venous branch tube; The pressure structure is activated, and the pressure delivered by the pressure structure is used to continuously inject the anticoagulant drug into the arterial branch at a preset speed through the arterial branch, and to continuously inject the anticoagulant drug into the venous branch at a preset speed through the venous branch.

9. The method for closing the catheter during non-treatment periods for blood purification treatment catheters according to claim 8, characterized in that, The pressure structure includes: a pressurized infusion device including a pressure bag, and an adjustable-speed intravenous infusion pump including a micro-pump.

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