A method for blood sampling from the right adrenal vein

Abstract

This invention discloses a method for blood collection from the right adrenal vein, belonging to the field of venous blood collection methods. The method includes the following steps: providing an RH catheter, which is a dedicated catheter for hepatic artery angiography, with its tip bent 180° to form a plane, and its tip bent perpendicularly to this plane at 90°; inserting the RH catheter through the right femoral vein, advancing it to form a loop in the right atrium, and then pulling it back to the inferior vena cava; adjusting the direction of the RH catheter, using its three-dimensional curved portion to hook onto the opening of the right adrenal vein, thereby inserting it into the right adrenal vein; injecting contrast agent to confirm that the tip of the RH catheter is located within the right adrenal vein; collecting a blood sample from the right adrenal vein through the RH catheter, with a single blood sample volume of 12 ml; after blood collection, performing post-confirmation angiography to verify whether the RH catheter is located within the target vein. This invention can significantly improve the success rate of right-side catheter insertion and blood collection efficiency, while reducing costs and facilitating operation.

Description

Technical Field

[0001] This invention relates to the field of venous blood collection methods, specifically a method for collecting blood from the right adrenal vein. Background Technology

[0002] Adrenal vein sampling is the gold standard for functional localization in differentiating between unilateral and bilateral adrenal lesions, and is crucial for surgical treatment decisions in primary aldosteronism (PA). However, the right adrenal vein has a very low success rate with conventional catheter insertion due to its complex anatomy (small diameter, usually less than 3 mm; short length, about 5 mm; and often draining into the inferior vena cava at an acute or right angle).

[0003] In traditional adrenal vein blood collection procedures, blood collection often fails or results in insufficient sample volume because the catheter tip cannot stably hook onto the opening of the right adrenal vein, or because of "adhesion to the wall." Blood collection failure not only means that the patient has to endure the risk and pain of a second surgery, but may also lead to misdiagnosis, causing the patient to face serious consequences such as the wrong removal of the non-functional adrenal gland or lifelong ineffective drug treatment.

[0004] In existing technologies, some approaches attempt to improve catheter design to increase success rates, commonly using microcatheters or specially pre-shaped catheters. However, these approaches are often costly, complex to operate, and require a high level of technical skill from primary care physicians, making them difficult to implement in hospitals with limited medical resources. Therefore, there is an urgent need in this field for a simple, high-success-rate, low-cost, and easily deployable right adrenal vein blood collection technique.

[0005] To address this issue, those skilled in the art have provided a method for collecting blood from the right adrenal vein. Summary of the Invention

[0006] The purpose of this invention is to provide a method for blood collection from the right adrenal vein, which can significantly improve the success rate of right-side cannulation and blood collection efficiency, reduce costs, and facilitate operation, thereby solving the problems mentioned in the background art.

[0007] To achieve the above objectives, the present invention provides the following technical solution: A method for collecting blood from the right adrenal vein includes the following steps: A hepatic artery angiography catheter is provided. The tip of the catheter is bent 180° to form a plane, and its tip is bent 90° perpendicular to this plane to create a three-dimensional stable structure. It can pass through a guidewire with a diameter of 0.035 inches, and the sidewall of the tip has at least one auxiliary blood collection port 3 mm away from the tip. The RH catheter includes a composite structure of rigid and flexible sections. The rigid section contains a stainless steel braided mesh to provide support, and the flexible section contains a hydrophilic coating to enhance vascular permeability. The RH catheter was inserted through the right femoral vein and advanced into the right atrium under fluoroscopic guidance to form a loop before being pulled back into the inferior vena cava; Adjust the direction of the RH catheter so that the tip turns to the lower right and uses its three-dimensional curved part to hook the opening of the right adrenal vein, thereby inserting it into the right adrenal vein; A contrast agent was injected to confirm that the tip of the RH catheter was located within the right adrenal vein; After blood collection, a post-confirmation angiography is performed to verify whether the RH catheter is located in the target vein.

[0008] As a further aspect of the present invention: a preoperative examination is required before providing the RH catheter, including an enhanced abdominal CT scan to assess the location, diameter, and angulation of the right adrenal vein; Preoperative examinations also include assessing basic physiological parameters, including blood pressure, electrolytes, and aldosterone levels, and ruling out contraindications for adrenal vein blood sampling.

[0009] As a further aspect of the present invention, the step of adjusting the direction of the RH catheter includes using a three-step positioning method, which includes: first, looping the RH catheter and pulling it back, with the tip placed on the right posterior wall of the inferior vena cava; second, slowly retracting the RH catheter until the tip snaps into the opening of the right adrenal vein; and third, finely adjusting the angle of the RH catheter to adapt to the anatomy of the right adrenal vein, and achieving continuous blood flow through the auxiliary blood collection port.

[0010] As a further aspect of the present invention, it also includes a step of collecting blood from the left adrenal vein using a SIM2 catheter, and the interval between blood collection from the right and left sides does not exceed 5 minutes to reduce the impact of ACTH level fluctuations on the test results; the blood collection from the left adrenal vein and the blood collection from the right side form a sequential operation, namely a "right RH catheter + left SIM2 catheter sequential" process, wherein the location of both blood collections is confirmed by injecting contrast agent, and the single blood collection volume is 12ml.

[0011] As a further aspect of the present invention, it also includes postoperative quality control steps, including detecting the aldosterone to cortisol ratio in blood samples and determining the dominant secretory side based on the comparison of hormone levels in the bilateral adrenal veins, wherein a cortisol gradient (adrenal vein / inferior vena cava) ≥2:1 is considered a qualified blood sample; the postoperative quality control steps also include recording the operation time, contrast agent dosage, and complications, and incorporating them into the technical quality control database; when the qualified blood sample rate is lower than a set threshold, an alarm is triggered through the digital quality control system, and a remote guidance or sample external testing mechanism is initiated.

[0012] As a further aspect of the present invention: during the blood collection process, a pressure monitor is used to monitor venous pressure and keep the pressure below 20 mmHg; the pressure monitor is integrated with the catheter and automatically alarms when the pressure exceeds the threshold; at the same time, a preset flow rate contrast agent can be used, with each injection dose not exceeding 5 ml.

[0013] As a further aspect of the present invention: the RH catheter is a 5F-RH catheter, and the auxiliary blood collection port is circular or elliptical with a diameter of 0.5-1mm, which is used to avoid blood collection failure caused by the tip sticking to the wall.

[0014] As a further aspect of the present invention: the catheter is positioned using IEV imaging technology to improve insertion accuracy; the rigid and flexible sections of the catheter are connected by a composite process, wherein the length of the rigid section accounts for 60%-70% of the total length of the catheter, and the length of the flexible section accounts for 30%-40%, so as to balance support and vascular passage.

[0015] As a further aspect of the present invention: the method is used to assist in the examination of primary aldosteronism or adrenal tumors by comparing hormone levels through bilateral adrenal vein blood sampling to accurately distinguish between unilateral or bilateral lesions.

[0016] This application also discloses an adrenal vein blood collection system, including a catheter, a guidewire, and a quality control device; the guidewire has a diameter of 0.035 inches and is used to guide catheter insertion; the quality control device includes a pressure monitor, a rapid cortisol detector, and a digital quality control unit. The rapid cortisol detector is used to quickly detect cortisol levels, and the digital quality control unit is used to monitor the blood collection pass rate, complication rate, and operation time in real time, and is connected to a remote guidance platform to enable experts to annotate the catheter turning angle in real time; the system also includes a standardized toolkit containing a pre-shaped catheter, an operation flowchart, and a complication management guide.

[0017] Compared with the prior art, the beneficial effects of the present invention are: This application significantly improves the success rate and operational efficiency of right adrenal vein blood collection, while greatly enhancing surgical safety through effective complication prevention mechanisms (such as pressure monitoring and side-hole anti-adhesion). This technical solution combines high suitability for primary care and low cost, effectively reducing the burden on patients and medical insurance expenditures. Furthermore, with its standardized and digital characteristics, it breaks down the barriers to promoting this precision diagnosis and treatment technology at the primary care level, ultimately realizing the popularization of the "gold standard" technology for the diagnosis of endocrine diseases. Attached Figure Description

[0018] Figure 1 A flowchart of a method for blood collection from the right adrenal vein; Figure 2 This is a schematic diagram of the RH conduit of this application. Detailed Implementation

[0019] 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.

[0020] As mentioned in the background section of this application, research has revealed that existing technologies include several approaches to improve catheter design and increase success rates, commonly employing microcatheters or specially pre-shaped catheters. However, these approaches are often costly, complex to operate, and require a high level of technical expertise from primary care physicians, making them difficult to implement in hospitals with limited medical resources and thus possessing certain drawbacks.

[0021] To address the aforementioned deficiencies, this application discloses a method for blood collection from the right adrenal vein, which can significantly improve the success rate of right-side cannulation and blood collection efficiency, while also reducing costs and facilitating operation.

[0022] The following will describe in detail, with reference to the accompanying drawings, how the solution of this application solves the above-mentioned technical problems.

[0023] Please see Figure 1 In this embodiment of the invention, a method for blood collection from the right adrenal vein includes the following steps: providing an RH catheter, which is a catheter specifically designed for hepatic arteriography. The tip is bent 180° in a spiral shape to form a plane, and the tip is bent perpendicularly to this plane at a 90° angle, creating a three-dimensional stable structure. A 0.035-inch guidewire can pass through this structure, and the sidewall of the tip has at least one auxiliary blood collection port located 3 mm from the tip. The RH catheter includes a composite structure of a rigid section and a flexible section. The rigid section contains a stainless steel braided mesh to provide support, and the flexible section contains a hydrophilic coating to enhance blood flow. The procedure involves inserting the RH catheter through the right femoral vein and, under fluoroscopic or digital subtraction angiography guidance, advancing it to form a loop in the right atrium before retracting it to the inferior vena cava. The direction of the RH catheter is adjusted to insert it into the right adrenal vein. A contrast agent is injected to confirm that the tip of the RH catheter is located within the right adrenal vein. A blood sample is collected from the right adrenal vein through the RH catheter. The single blood collection volume is 12 ml. After blood collection, a post-confirmation angiography is performed to verify whether the RH catheter is located within the target vein. This application provides a structurally specialized RH catheter (three-dimensional stable structure, side-wall auxiliary blood collection port, and rigid-flexible composite structure) and specifies its specific insertion, confirmation, and blood collection procedures, systematically solving the technical problems of low insertion success rate due to the complex anatomy of the right adrenal vein and blood collection failure caused by the easy "adherence" of traditional catheters.

[0024] In this embodiment, preoperative examinations are required before providing the RH catheter. These examinations include an enhanced abdominal CT scan to assess the location, diameter, and angulation of the right adrenal vein. Preoperative examinations also include assessing baseline physiological parameters, including blood pressure, electrolytes, and aldosterone levels, and ruling out contraindications for adrenal vein blood collection. This setup integrates preoperative imaging assessment (enhanced abdominal CT) and patient physiological screening as essential preliminary steps. By pre-assessing the vein diameter and angulation and ruling out contraindications, it provides crucial data support and safety assurance for the accurate selection of the subsequent catheter type and the safe implementation of the procedure, achieving a shift from "blind operation" to "data-guided" approach.

[0025] In this embodiment, the steps for adjusting the direction of the RH catheter include using a three-step positioning method. The three-step positioning method consists of: first, looping the RH catheter and pulling it back until the tip is positioned on the right posterolateral wall of the inferior vena cava; second, slowly retracting the RH catheter until the tip snaps into the opening of the right adrenal vein; and third, fine-tuning the angle of the RH catheter to adapt to the anatomy of the right adrenal vein, achieving continuous blood flow through an auxiliary blood collection port. This setup introduces a standardized "three-step positioning method" operating procedure, breaking down the catheter adjustment process, which relies on personal experience, into three clearly defined, replicable, and teachable steps. Combined with superselective cannulation techniques, this significantly reduces the difficulty and variability of the procedure, ensuring that even in the presence of anatomical variations (such as short right-angled veins), physicians can efficiently and accurately position the catheter.

[0026] In this embodiment, the procedure also includes left adrenal vein blood collection using a SIM2 catheter, with the interval between right and left blood collection not exceeding 5 minutes to reduce the impact of ACTH level fluctuations on the test results. Left adrenal vein blood collection and right-side blood collection form a sequential operation, i.e., a "right RH catheter + left SIM2 catheter sequential" process. Both sides use contrast agent injection to confirm location, and the single blood volume is 12ml. This setup extends the unilateral blood collection method to a complete bilateral sequential blood collection protocol. By limiting the use of the SIM2 catheter for left-side blood collection and strictly controlling the time interval between bilateral blood collections (≤5 minutes), it effectively reduces hormone level detection errors, thereby ensuring the accuracy and reliability of bilateral hormone comparison data.

[0027] In this embodiment, postoperative quality control steps are also included, including detecting the aldosterone to cortisol ratio in blood samples and determining the dominant secretory side based on the comparison of hormone levels in both adrenal veins. A cortisol gradient (adrenal vein / inferior vena cava) ≥2:1 is considered a qualified blood collection. Postoperative quality control steps also include recording the operation time, contrast agent dosage, and complications, and incorporating these into the technical quality control database. When the qualified blood collection rate falls below a set threshold, an alarm is triggered through the digital quality control system, and a remote guidance or sample external testing mechanism is initiated. This setup establishes a closed-loop postoperative quality control system. By setting quantified qualified blood collection standards (cortisol gradient ≥2:1), recording data in the database, and introducing digital early warning and intervention mechanisms (triggering alarms, remote guidance), it ensures the quality control and reliability of each blood collection operation, and achieves long-term quality assurance without compromising standards during technology promotion.

[0028] In this embodiment, during blood collection, a pressure monitor is used to monitor venous pressure and maintain it below 20 mmHg to prevent venous injury or bleeding. The pressure monitor is integrated with the catheter and automatically alarms when the pressure exceeds the threshold. Simultaneously, a preset flow rate of contrast agent can be used, with each injection not exceeding 5 ml to reduce the risk of complications. This setup deeply embeds proactive safety measures into the blood collection process. By integrating pressure monitoring and limiting contrast agent dosage, it directly prevents complications such as venous injury and bleeding at the physical level, shifting surgical risk from "post-operative management" to "in-process prevention," significantly improving the overall safety threshold of the method.

[0029] In this embodiment, the RH catheter is a 5F-RH catheter, and the auxiliary blood collection port is round or oval with a diameter of 0.5-1mm, which is used to avoid blood collection failure caused by the tip sticking to the wall.

[0030] In this embodiment, the RH catheter can also integrate a pressure-sensing guidewire for real-time monitoring of venous pressure, with a pressure threshold set at 20 mmHg. The catheter uses IEV imaging technology to assist in positioning, improving insertion accuracy. The rigid and flexible sections of the catheter are connected using a composite process, with the rigid section accounting for 60%-70% of the total catheter length and the flexible section accounting for 30%-40%, balancing support and vascular permeability. This configuration represents an intelligent upgrade to the catheter itself. By integrating the pressure-sensing guidewire and IEV imaging technology, it provides real-time physiological feedback and precise visualization capabilities. Furthermore, by quantifying the rigid-flexible section ratio, the overall performance of the catheter is optimized, transforming it from a passive manipulation tool into an active, intelligent diagnostic and treatment platform.

[0031] In this embodiment, the method is used to assist in the examination of primary aldosteronism or adrenal tumors. By comparing hormone levels through bilateral adrenal vein blood sampling, unilateral or bilateral lesions can be accurately distinguished.

[0032] This application also discloses an adrenal vein blood collection system, including a catheter, guidewire, and quality control equipment. The guidewire has a diameter of 0.035 inches and is used to guide catheter insertion. The quality control equipment includes a pressure monitor, a rapid cortisol meter, and a digital quality control unit. The rapid cortisol meter is used to quickly detect cortisol levels, and the digital quality control unit is used to monitor the blood collection pass rate, complication rate, and operation time in real time, and is connected to a remote guidance platform to enable experts to annotate the catheter turning angle in real time. The system also includes a standardized toolkit containing pre-shaped catheters, operation flowcharts, and complication management guidelines. This setup constructs an integrated solution system, modularly combining specialized catheters and guidewires with advanced quality control equipment and standardized toolkits to form a complete ecosystem of "hardware + software + services."

[0033] This invention combines a structurally modified RH catheter (with a specific bending angle, side-wall blood collection port, and a rigid-flexible composite structure) with standardized operating procedures (such as the "three-step positioning method" and sequential blood collection), intelligent quality control methods (pressure monitoring, digital systems), and a systematic promotion toolkit, resulting in integrated beneficial effects: significantly improving the success rate and operational efficiency of right adrenal vein blood collection, while greatly enhancing surgical safety through effective complication prevention mechanisms (such as pressure monitoring and side-hole anti-adhesion); this technical solution has the advantages of high suitability for primary care and low cost, effectively reducing the burden on patients and medical insurance expenditures, and with its standardized and digital characteristics, it breaks down the barriers to promoting this precision diagnosis and treatment technology to primary care, ultimately realizing the popularization of the "gold standard" technology for the diagnosis of endocrine diseases.

[0034] Obviously, those skilled in the art can make various modifications and variations to this invention without departing from its spirit and scope. Therefore, if these modifications and variations fall within the scope of the claims of this invention and their equivalents, this invention also intends to include these modifications and variations.

[0035] The above description is merely a preferred embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any equivalent substitutions or modifications made by those skilled in the art within the scope of the technology disclosed in the present invention, based on the technical solution and inventive concept of the present invention, should be covered within the scope of protection of the present invention.

Claims

1. A method for collecting blood from the right adrenal vein, characterized in that, Includes the following steps: A hepatic artery angiography catheter is provided. The tip of the catheter is bent 180° to form a plane, and its tip is bent 90° perpendicular to the plane to create a three-dimensional stable structure. It can pass through a guidewire with a diameter of 0.035 inches. An auxiliary blood collection port is provided on the sidewall of the tip 3 mm away from the tip. The hepatic artery angiography catheter includes a composite structure of a rigid section and a flexible section. The rigid section contains a stainless steel braided mesh to provide support, and the flexible section contains a hydrophilic coating to enhance vascular permeability. The RH catheter is inserted through the right femoral vein, advanced into the right atrium to form a loop, and then pulled back into the inferior vena cava; Adjust the direction of the RH catheter and use its three-dimensional curved part to hook the opening of the right adrenal vein, thereby inserting it into the right adrenal vein; A contrast agent was injected to confirm that the tip of the RH catheter was located within the right adrenal vein; Blood samples were collected from the right adrenal vein via the RH catheter, with a single blood sample volume of 12 ml. After blood collection, a post-confirmation angiography is performed to verify whether the RH catheter is located in the target vein.

2. The method for blood collection from the right adrenal vein according to claim 1, characterized in that, Preoperative examinations are required before the RH catheter is delivered. These examinations include an enhanced abdominal CT scan to assess the location, diameter, and angulation of the right adrenal vein. Preoperative examinations also include assessing basic physiological parameters, including blood pressure, electrolytes, and aldosterone levels, and ruling out contraindications for adrenal vein blood sampling.

3. The method for blood collection from the right adrenal vein according to claim 2, characterized in that, The steps for adjusting the direction of the RH catheter include using a three-step positioning method, which includes: first, looping the RH catheter and pulling it back, with the tip placed on the right posterior wall of the inferior vena cava; second, slowly withdrawing the RH catheter until the tip snaps into the opening of the right adrenal vein; and third, finely adjusting the angle of the RH catheter to adapt to the anatomy of the right adrenal vein, and achieving continuous blood flow through the auxiliary blood collection port.

4. The method for collecting blood from the right adrenal vein according to claim 3, characterized in that, It also includes the step of drawing blood from the left adrenal vein using a SIM2 catheter, with the interval between blood collection from the right and left sides not exceeding 5 minutes; the blood collection from the left adrenal vein and the blood collection from the right side form a sequential operation, wherein the location of both blood collections is confirmed by injecting contrast agent, and the blood volume of each collection is 12ml.

5. A method for collecting blood from the right adrenal vein according to claim 4, characterized in that, It also includes postoperative quality control steps, including detecting the ratio of aldosterone to cortisol in blood samples and determining the dominant secretory side based on the comparison of hormone levels in the bilateral adrenal veins, where a cortisol gradient ≥2:1 is considered a qualified blood collection. The postoperative quality control steps also include recording the operation time, contrast agent dosage, and complications, and incorporating them into the technical quality control database; when the blood collection pass rate is lower than the set threshold, an alarm is triggered through the digital quality control system, and a remote guidance or sample external testing mechanism is initiated.

6. A method for collecting blood from the right adrenal vein according to claim 5, characterized in that, During blood collection, a pressure monitor should be used simultaneously to monitor venous pressure and keep it below 20 mmHg. The pressure monitor is integrated with the catheter and will automatically alarm when the pressure exceeds the threshold. A preset flow rate contrast agent can also be used, with each injection dose not exceeding 5 ml.

7. A method for collecting blood from the right adrenal vein according to claim 6, characterized in that, The RH catheter is a 5F-RH catheter, and the auxiliary blood collection port is round or elliptical with a diameter of 0.5-1.0 mm.

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