A kit for ultrasound-guided percutaneous puncture and drainage sclerotherapy of lower abdominal cysts

Abstract

This invention relates to a kit for ultrasound-guided percutaneous drainage and sclerotherapy of abdominal cysts, belonging to the field of medical device technology. It includes a drainage catheter, a puncture needle, a three-way valve, an anti-backflow drainage bag, a skin fixation patch, and a protein testing kit. The drainage catheter has a hollow cavity for the puncture needle to pass through. One end of the drainage catheter, near the operator, has an interface for connecting the puncture needle or one end of the three-way valve; the other end of the three-way valve connects to the anti-backflow drainage bag. The skin fixation patch non-invasively fixes the external segment of the drainage catheter to the body surface. This invention makes ultrasound-guided percutaneous drainage and sclerotherapy of abdominal cysts safer, more effective, and less strenuous; it is especially suitable for short-term, staged drainage and sclerotherapy of large cysts; it effectively avoids problems such as insufficient drainage of cyst fluid, bleeding from the cyst wall and surrounding tissue, and leakage of the sclerosing agent due to slippage of the puncture needle or drainage tube, ensuring treatment effectiveness.

Description

Technical Field

[0001] This invention relates to a kit for ultrasound-guided percutaneous puncture and drainage sclerotherapy of abdominal cysts, belonging to the field of medical device technology. Background Technology

[0002] The most common abdominal cysts are liver and kidney cysts, which are frequent and prevalent clinical conditions with a high incidence rate in the population. Kidney cysts have a detection rate as high as 50% in people over 50 years of age. Simple liver and kidney cysts are cystic masses with a complete structure and are benign lesions. The fluid within the cyst remains relatively stable due to a certain degree of exchange between the cyst wall and surrounding organs and tissues. Smaller cysts may be asymptomatic and require no treatment. Some cysts may slowly enlarge due to secretion from the cyst wall cells and relatively large amounts of fluid entering from surrounding tissues. Larger cysts can cause compressive symptoms, compressing surrounding tissues or organs, and even causing damage to the function of the corresponding tissues or organs. Currently, treatment methods for symptomatic abdominal cysts include laparoscopic fenestration, surgical resection, and ultrasound-guided percutaneous drainage sclerotherapy. Compared to surgical treatment, ultrasound-guided percutaneous drainage sclerotherapy, as a minimally invasive treatment method, is widely used in clinical practice due to its clear therapeutic effect, low recurrence rate, low surgical cost, and good patient tolerance. After puncture and drainage sclerotherapy, the original balance of fluid inflow and outflow is disrupted, leading to degeneration and necrosis of the cyst wall tissue. Ultimately, the cyst wall shrinks and the cyst cavity gradually shrinks or closes due to the reduction and blockage of fluid production and inflow.

[0003] The most common clinical method for ultrasound-guided percutaneous transcatheter sclerotherapy of hepatic and renal cysts is the use of a 21-18G percutaneous catheter (PTC needle). A 30-60ml syringe is connected via a tubing for aspiration of cyst fluid and injection of sclerosing agent. While the percutaneous catheter is relatively convenient and inexpensive, it requires a high level of skill and experience from the surgeon. The surgeon must carefully select the appropriate cyst insertion point, and the needle angle must be carefully considered in advance to account for the potential for significant displacement (repositioning) of the cyst and surrounding organs after fluid aspiration and cyst wall collapse. This is crucial to prevent accidental needle tip injury to the cyst wall and surrounding organ parenchyma, which could lead to intracystic bleeding or needle dislodgement and extravasation of the sclerosing agent. Throughout the treatment, the surgeon must monitor the aspiration process with ultrasound in real time and continuously adjust the needle position to ensure the needle tip is centered on the cyst, maximizing fluid drainage without damaging the cyst wall or surrounding organs. This treatment method presents increased difficulty and risk for cysts that have partially collapsed, resulting in significant displacement (return) and making needle tip visualization difficult, or for cysts located close to vital organs such as the heart and major blood vessels. Operators often avoid injury, leading to insufficient aspiration of cyst fluid and irrigation with sclerosing agents, thus affecting treatment outcomes. A small percentage of patients may also experience complications such as bleeding within the cyst or surrounding organs. During the puncture and drainage of large abdominal cysts, direct and rapid aspiration of cyst fluid can cause a sudden drop in pressure, leading to discomfort, and manual aspiration is time-consuming and labor-intensive. The effectiveness of a single puncture and sclerotherapy for these large abdominal cysts is often limited, and recurrence is common.

[0004] In recent years, 16-18G plastic straight cannulas have also been used clinically. In practice, some patients experience cannula dislodgement due to significant displacement (return) after cyst fluid aspiration and cyst wall collapse, leading to extravasation of the sclerosing agent. There are also reports of using 6-10F pigtail catheters for ultrasound-guided percutaneous sclerotherapy of liver and kidney cysts, but currently there are no products specifically designed for sclerotherapy of abdominal cysts. Furthermore, currently in clinical cyst sclerotherapy, qualitative tests of cyst fluid proteins involve dripping the cyst fluid into anhydrous ethanol and observing whether the liquid becomes cloudy, relying on subjective observation. However, more and more physicians are now using polidocanol injection as a sclerosing agent, or some medical institutions cannot provide anhydrous ethanol, making this method unsuitable for cyst fluid protein testing. Therefore, there is an urgent need in this technical field for a safe and reliable ultrasound-guided percutaneous puncture and drainage sclerotherapy kit for abdominal cysts. This kit can improve the process of minimally invasive percutaneous puncture and drainage sclerotherapy for abdominal cysts, maximize the treatment effect, minimize complications and trauma, and allow for intraoperative adjustments to the treatment plan based on the actual nature of the cyst fluid in the abdominal cyst. Summary of the Invention

[0005] The purpose of this invention is to solve the technical problem of how to obtain a safe and reliable kit for ultrasound-guided percutaneous puncture, drainage and sclerotherapy of abdominal cysts. This kit can improve the process of minimally invasive percutaneous puncture, drainage and sclerotherapy of abdominal cysts, maximize the treatment effect, minimize complications and trauma, and allow for intraoperative adjustment of the treatment plan according to the actual properties of the cyst fluid in the abdominal cavity.

[0006] To address the aforementioned problems, the present invention provides a kit for percutaneous sclerotherapy of abdominal cysts under ultrasound guidance, comprising a drainage catheter, a puncture needle, a three-way valve, an anti-backflow drainage bag, a skin fixation patch, and a protein testing kit. The drainage catheter has a hollow cavity for the puncture needle to pass through. One end of the drainage catheter near the operator has an interface for connecting the puncture needle or one end of the three-way valve, and the other end of the three-way valve is connected to the anti-backflow drainage bag. The skin fixation patch can non-invasively fix the external segment of the drainage catheter to the body surface.

[0007] Preferably, the end of the drainage catheter away from the operator is provided with an end hole for exposing the tip of the puncture needle; the side wall of the drainage catheter near the end hole is provided with multiple elliptical side holes.

[0008] Preferably, the plurality of side holes are arranged in a line parallel to the central axis of the drainage conduit along the sidewall of the drainage conduit.

[0009] Preferably, the drainage catheter has graduations on its sidewall.

[0010] Preferably, the drainage tube is provided with a fixing line for pulling the bent end of the drainage tube away from the operator; one end of the fixing line is located on the side wall near the end hole of the drainage tube, and the other end is provided with a fixing device.

[0011] Preferably, the end of the drainage tube closest to the operator is provided with a slot for installing a fixing device.

[0012] Preferably, the end of the drainage catheter near the operator is provided with a threaded interface one, and the end of the puncture needle near the operator is provided with a threaded interface two that corresponds to and matches the threaded interface one.

[0013] Preferably, the end of the drainage catheter closest to the operator is provided with a threaded interface 1, and one end of the three-way valve is provided with a threaded interface 3 that corresponds to and matches the threaded interface 1.

[0014] Preferably, the protein test kit has a dripping area for dripping capsule fluid and a display area for displaying the protein detection results in the capsule fluid.

[0015] Preferably, the skin fixation patch has an adhesive surface for adhering to the skin; the skin fixation patch also has Velcro for wrapping and fixing the drainage catheter.

[0016] Preferably, the diameter of the drainage catheter is 6F.

[0017] Compared with the prior art, the present invention has the following beneficial effects:

[0018] This invention provides a safe and reliable kit for ultrasound-guided percutaneous drainage and sclerotherapy of abdominal cysts, making this treatment safer, more effective, and less labor-intensive; it is especially suitable for short-term, staged drainage and sclerotherapy of large cysts. It effectively avoids problems such as insufficient drainage of cyst fluid, bleeding from the cyst wall and surrounding tissue, and leakage of the sclerosing agent due to slippage of the puncture needle or drainage tube, ensuring treatment effectiveness. During cyst sclerotherapy, the test kit in this kit provides an objective, accurate, and timely protein assay tool. Attached Figure Description

[0019] Figure 1 This is a schematic diagram of the 6F pig tail drainage catheter needle structure in an embodiment of the present invention.

[0020] Figure 2 This is a schematic diagram of the cyst fluid drainage system in an embodiment of the present invention.

[0021] Figure 3 This is a schematic diagram of the skin fixation patch structure for the drainage catheter in an embodiment of the present invention.

[0022] Figure 4 This is a schematic diagram of the cyst fluid protein qualitative test kit in an embodiment of the present invention.

[0023] Reference numerals: 1. Drainage catheter; 2. Puncture needle; 3. Fixation suture; 4. Fixation device; 5. Slot; 6. Three-way valve; 7. Anti-backflow drainage bag; 8. Skin fixation tape; 9. Velcro 1; 10. Velcro 2; 11. Test kit; 12. Infusion area; 13. Display area. Detailed Implementation

[0024] To make the present invention more apparent and understandable, preferred embodiments are described in detail below:

[0025] like Figure 1-4As shown, the technical solution adopted by the present invention is to provide a kit for percutaneous puncture and drainage sclerotherapy of abdominal cysts under ultrasound guidance, including a drainage catheter 1, a puncture needle 2, a three-way valve 6, an anti-backflow drainage bag 7, a skin fixation patch 8, and a protein test kit 11; the drainage catheter 1 has a hollow cavity for the puncture needle 2 to pass through; the end of the drainage catheter 1 near the operator has an interface for connecting the puncture needle 2 and one end of the three-way valve 6, and the other end of the three-way valve 6 is connected to the anti-backflow drainage bag 7; the skin fixation patch 8 can non-invasively fix the external segment of the drainage catheter 1 to the body surface. The end of the drainage catheter 1 away from the operator has an end hole for exposing the tip of the puncture needle 2; the side wall of the drainage catheter 1 near the end hole has multiple elliptical side holes. The multiple side holes are arranged in a line parallel to the central axis of the drainage catheter 1 along the side wall of the drainage catheter 1. The side wall of the drainage catheter 1 has graduations. The drainage catheter 1 has a fixing line 3 for pulling and bending the end of the drainage catheter 1 away from the operator; one end of the fixing line 3 is located on the side wall near the end hole of the drainage catheter 1, and the other end has a fixing device 4. The end of the drainage catheter 1 near the operator has a slot 5 for installing the fixing device 4. The end of the drainage catheter 1 near the operator has a threaded interface 1, and the end of the puncture needle 2 near the operator has a threaded interface 2 that matches the threaded interface 1; one end of the three-way valve 6 also has a threaded interface 3 that matches the threaded interface 1. The protein test kit 11 has a drip area 12 for dripping cyst fluid and a display area 13 for displaying the protein detection results in the cyst fluid. The skin fixation patch 8 has an adhesive surface for adhering to the skin; the skin fixation patch 8 has Velcro for wrapping and fixing the drainage catheter 1. The diameter of the drainage catheter is 6F.

[0026] Example

[0027] This invention provides an ultrasound-guided percutaneous sclerotherapy kit for various types of abdominal cysts, used for continuous minimally invasive treatment including cyst fluid drainage, cyst cavity irrigation, cyst fluid testing, and sclerotherapy irrigation. It can also be left in place for short periods for staged sclerotherapy of large abdominal cysts. This improves the efficiency of percutaneous sclerotherapy for abdominal cysts and saves physician labor.

[0028] This invention kit includes a 6F (2mm diameter) pigtail drainage catheter 1, a puncture needle 2, a three-way valve 6, an anti-backflow drainage bag 7, a skin fixation patch 8, and a cyst fluid protein qualitative test kit 11. Under ultrasound guidance, the tip of the puncture needle 2 in the drainage catheter 1 can be clearly displayed, helping physicians to accurately locate and successfully percutaneously puncture the abdominal cyst. After removing the puncture needle core from the drainage catheter 1, the tip of the drainage catheter 1 automatically curls up, tightening the internal fixation line 3 and securing it in the groove 5 at the tail end of the drainage catheter 1 via a fixing device 4, preventing the drainage catheter 1 from slipping out of the cyst wall. The tail end of the drainage catheter 1 is connected to the anti-backflow drainage bag 7 via the three-way valve 6 to drain the cyst fluid. The color and volume of the cyst fluid can be observed through the anti-backflow drainage bag 7. The three-way valve 6 allows for aspiration of cyst fluid, flushing of the cyst cavity, and injection of a sclerosing agent. The cyst fluid protein qualitative test kit 11 allows for direct on-site measurement of cyst fluid proteins during surgery. The skin fixation patch 8 can be adhered to the skin and non-invasively fixed outside the body through the drainage catheter 1 to prevent the drainage catheter from slipping out. This allows for short-term placement of the drainage catheter 1 within the cyst for staged drainage and sclerotherapy.

[0029] Currently, practical application has shown that the most suitable disposable drainage catheter for pleural and peritoneal effusion aspiration in clinical use is the 6F diameter catheter for sclerotherapy of abdominal cysts. Its diameter allows for unobstructed drainage of the cyst fluid while minimizing trauma and preventing extravasation of the sclerosing agent. It also requires less real-time monitoring by the operating physician.

[0030] As attached Figure 1 The diagram shows the structure of a 6F pigtail drainage catheter needle in an embodiment of the present invention: a 6F (2mm diameter) pigtail drainage catheter needle. The outer surface is a hollow pigtail catheter made of hydrophilic latex. The tapered tip of the catheter ensures a close fit between the catheter and the puncture needle, facilitating smooth insertion into the tissue. The drainage catheter 1 has a pointed end hole and four oval side holes. The catheter body has markings representing the distance from the tip, facilitating monitoring of the insertion depth by medical personnel. The tail end of the drainage catheter 1 is a spiral opening, which can be screwed together with the spiral opening of the tail end of the puncture needle 2 inside. The tip of the puncture needle 2 protrudes beyond the tip of the drainage catheter 1. The material of the needle tip ensures clear visibility under ultrasound, helping physicians accurately control the puncture path. The fixing wire 3 inside the drainage catheter 1 can be secured in the slot 5 of the drainage catheter 1 by the fixing device 4 to fix the coiled state of the drainage catheter 1 tip.

[0031] As attached Figure 2 The diagram shown is a schematic of the cyst fluid drainage system in an embodiment of the present invention. It includes a pigtail drainage catheter 1 with its tip curled up after the internal puncture needle core has been removed, an internal fixing wire 3, a fixing device 4 for fixing the fixing wire 3 to the slot 5, a three-way valve 6, and an anti-backflow drainage bag 7.

[0032] As attached Figure 3The diagram shown is a schematic of the skin fixation patch structure for the drainage catheter in an embodiment of the present invention. The skin fixation patch 8 includes a skin adhesion area with an adhesive backing, an adhesion area with Velcro 9, and Velcro 10 for fixing the drainage catheter 1.

[0033] As attached Figure 4 The diagram shown is a schematic representation of the cyst fluid protein qualitative test kit in an embodiment of the present invention. The cyst fluid protein qualitative test kit 11 includes a built-in protein test strip area, a cyst fluid dispensing area 12, and a result display area 13. The protein test strip uses an indicator method, utilizing the principle that proteins react with a special indicator to change color, and the presence of protein in the cyst fluid is determined based on the color change of the test strip.

[0034] Use of this invention:

[0035] Under ultrasound, the needle tip of the 6F (2mm diameter) pigtail drainage catheter 1 is clearly visible. The catheter is percutaneously inserted into the abdominal cyst using a one-step method. After confirming the insertion of the pigtail catheter into the cyst, the spiral clamps are loosened, and the catheter is advanced into the cyst to a sufficient length. The internal puncture needle core is then removed. After removing the internal puncture needle core, the internal fixation suture 3 of the drainage catheter 1 is secured in the groove 5 at the tail end of the catheter 1 using the fixation device 4, thus fixing the head end of the catheter 1 in a coiled position. The drainage catheter 1 is connected to the anti-backflow drainage bag 7 via a three-way valve 6 to form a cyst fluid drainage system for draining the cyst fluid. The three-way valve 6 can be used to aspirate cyst fluid, flush the cyst cavity, and inject sclerosing agent. A skin fixation patch 8 is attached near the stoma of the drainage catheter 1. The movable Velcro 2 10 is crossed to fix the drainage catheter 1 within this area and secured to the adhesive area of ​​the Velcro 2 9, thus securing the external segment of the drainage catheter 1. Before injecting the sclerosing agent, a small amount of cyst fluid is drawn through the three-way valve 6 and dripped into the drip area 12 of the cyst fluid protein qualitative test kit 11 for protein qualitative testing. After the cyst puncture and drainage sclerotherapy is completed, the fixing line 3 of the groove 5 at the end of the drainage catheter 1 is loosened, and the drainage catheter 1 can be directly removed. Throughout the entire treatment process, the patient only has a tiny incision at the skin puncture point.

[0036] The above description is merely a preferred embodiment of the present invention and is not intended to limit the present invention in any form or substance. It should be noted that those skilled in the art can make various improvements and additions without departing from the present invention, and these improvements and additions should also be considered within the scope of protection of the present invention. Any modifications, alterations, and equivalent changes made by those skilled in the art based on the above-disclosed technical content without departing from the spirit and scope of the present invention are equivalent embodiments of the present invention. Furthermore, any modifications, alterations, and evolutions made to the above embodiments based on the essential technology of the present invention still fall within the scope of the technical solution of the present invention.

Claims

1. A kit for ultrasound-guided percutaneous puncture and drainage sclerotherapy of lower abdominal cysts, characterized in that, The device includes a drainage catheter, a puncture needle, a three-way valve, an anti-backflow drainage bag, a skin fixation patch, and a protein testing kit. The drainage catheter has a hollow cavity for the puncture needle to pass through. One end of the drainage catheter, near the operator, has an interface for connecting to either the puncture needle or one end of the three-way valve. The other end of the three-way valve connects to the anti-backflow drainage bag. The three-way valve has an interface for aspirating cyst fluid, rinsing the cyst cavity, and injecting sclerosing agent. The three-way valve can be connected to the end of the drainage catheter to achieve continuous aspiration, rinsing, and injection of medication while maintaining continuous closed drainage. The protein testing kit allows for real-time monitoring of cyst fluid protein concentration, enabling real-time adjustment of the sclerosing agent dosage during the procedure. A skin fixation patch is provided on the outer wall of the drainage catheter to secure it.

2. The kit for ultrasound-guided percutaneous puncture and drainage sclerotherapy of lower abdominal cysts according to claim 1, characterized in that, The end of the drainage catheter away from the operator is provided with an end hole for exposing the tip of the puncture needle; multiple side holes are provided on the side wall of the drainage catheter near the end hole; the diameter of the drainage catheter is 6F.

3. The kit for ultrasound-guided percutaneous puncture and drainage sclerotherapy of lower abdominal cysts according to claim 2, characterized in that, The multiple side holes are arranged in a line parallel to the central axis of the drainage conduit along the side wall of the drainage conduit.

4. The kit for ultrasound-guided percutaneous puncture and drainage sclerotherapy of lower abdominal cysts according to claim 1, characterized in that, The drainage catheter has graduations on its side wall.

5. The kit for ultrasound-guided percutaneous puncture and drainage sclerotherapy of lower abdominal cysts according to claim 1, characterized in that, The drainage tube is equipped with a fixing line for pulling the bent end of the drainage tube away from the operator; one end of the fixing line is located on the side wall near the end hole of the drainage tube, and the other end is equipped with a fixing device.

6. The kit for ultrasound-guided percutaneous puncture and drainage sclerotherapy of lower abdominal cysts according to claim 5, characterized in that, The end of the drainage tube closest to the operator is provided with a slot for installing a fixing device.

7. The kit for ultrasound-guided percutaneous puncture and drainage sclerotherapy of lower abdominal cysts according to claim 1, characterized in that, The end of the drainage catheter closest to the operator is provided with a threaded interface one, and the end of the puncture needle closest to the operator is provided with a threaded interface two that corresponds to and matches the threaded interface one.

8. The kit for ultrasound-guided percutaneous puncture and drainage sclerotherapy of lower abdominal cysts according to claim 1, characterized in that, The end of the drainage tube closest to the operator is provided with a threaded interface 1, and the end of the three-way valve is provided with a threaded interface 3 that corresponds to and matches the threaded interface 1.

9. A kit for ultrasound-guided percutaneous puncture and drainage sclerotherapy of lower abdominal cysts according to claim 1, characterized in that, The protein test kit has a drip area for dripping capsule fluid and a display area for displaying the protein detection results in the capsule fluid.

10. A kit for ultrasound-guided percutaneous puncture and drainage sclerotherapy of lower abdominal cysts according to claim 1, characterized in that, The skin fixation patch has an adhesive surface for adhering to the skin; the skin fixation patch also has Velcro for wrapping and fixing the drainage tube.

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