A puncture needle for hepatic arterial chemoembolization

Abstract

The application discloses a puncture needle for hepatic arterial chemoembolization, and belongs to the technical field of arterial puncture. The puncture needle comprises a puncture assembly, a valve mechanism and a needle body back-off mechanism. The puncture assembly comprises a transparent holding tube, a flexible sheath tube connected to the proximal end of the holding tube, and a puncture needle inserted into the flexible sheath tube from the distal end of the holding tube. The valve mechanism comprises a transparent blood return tube connected to the distal end of the puncture needle, and a valve valve sealing the distal end of the blood return tube. The needle body back-off mechanism comprises a hollow rotating cap screwed with the distal end of the holding tube, and an inner sleeve connecting the distal end of the blood return tube and the hollow rotating cap together. The transparent blood return tube is arranged in the transparent holding tube, and is sealed by the valve valve arranged at the distal end of the blood return tube. The valve valve is in a normally closed state, can prevent the loss of high-pressure blood in the artery, and reduces the risk of infection. The valve valve allows a guide wire or a microcatheter to directly pass through, and the puncture needle does not need to be removed, so that the operation steps can be reduced.

Description

Technical Field

[0001] This invention relates to a puncture needle for hepatic artery chemoembolization, belonging to the field of arterial puncture technology. Background Technology

[0002] Hepatic artery chemoembolization (TACE) is a local treatment method for diseases such as liver cancer, belonging to the field of minimally invasive interventional technology. Generally, under local anesthesia, the femoral artery is percutaneously punctured with a needle, and a puncture sheath is inserted to create a stable operating channel. Then, a guidewire and microcatheter are inserted into the celiac artery; angiography is performed on the hepatic artery and its branches to identify the blood supply arteries to the lesion; next, the microcatheter is inserted into the tumor-feeding artery, and an appropriate amount of chemotherapy drug is injected, allowing the drug to act directly on the tumor tissue; immediately afterward, embolic agents such as iodized oil or microspheres are injected to block the tumor's blood supply, thereby enhancing the drug's efficacy and causing tumor ischemia and necrosis; finally, another angiography confirms complete embolization of the feeding artery, the instruments are removed, and pressure is applied for hemostasis, completing the procedure. Through TACE, chemotherapy drugs and embolic agents are precisely delivered to the tumor-feeding artery, thereby blocking the blood supply and creating a high-concentration drug environment locally, achieving the dual effects of vascular occlusion and highly effective local chemotherapy. Compared to open surgery, TACE avoids extensive incisions and tissue damage, resulting in less trauma and faster recovery for the patient. Among these advantages, efficient and safe femoral artery puncture facilitates the rapid establishment of an operating channel, shortens the operation time, and leaves more time for subsequent chemotherapy drug injection and embolization.

[0003] Currently, the speed of puncture completion in puncture procedures often depends on the operator's experience, and the state of blood return is a crucial indicator of puncture success. Experienced operators can accurately determine puncture success by observing the blood return. For example, a Chinese patent for a vascular puncture device (application number: CN201820479624.X) can determine puncture success based on blood return, but it still has the following problems: if there is excessive blood return (especially arterial blood), the blood can easily overflow from the distal end of the puncture needle, increasing the risk of infection and exposure. Furthermore, hepatic artery chemoembolization mainly uses microcatheters, and the microcatheter and guidewire can be directly inserted through the puncture needle. To save operation time, it is possible to not remove the puncture needle; however, the tip of existing puncture needles is prone to puncturing blood vessels, and there is a lack of effective tip protection measures.

[0004] Therefore, a puncture needle for hepatic artery chemoembolization was designed. It can operate the valve mechanism as needed to allow controllable communication between the artery and the outside. Furthermore, the needle retraction mechanism allows the puncture needle to be retracted into a flexible sheath to prevent the tip from puncturing the blood vessel. This provides a certain degree of protection when the puncture needle is not completely removed from the guidewire. Summary of the Invention

[0005] The technical problem to be solved by the present invention is to provide a puncture needle for hepatic artery chemoembolization, which solves the problem that the puncture needle needs to be removed before inserting a microcatheter to inject chemotherapy drugs and embolic agents during hepatic artery chemoembolization, thus affecting the puncture efficiency.

[0006] The technical problem to be solved by this invention is achieved by the following technical solution:

[0007] A puncture needle for hepatic artery chemoembolization includes:

[0008] The puncture assembly includes a transparent holding tube and a flexible sheath connected to the proximal end of the holding tube, and a puncture needle inserted into the flexible sheath from the distal end of the holding tube;

[0009] The valve mechanism includes a transparent reflux vessel connected to the distal end of the puncture needle, and a valve valve that seals the distal end of the reflux vessel, the reflux vessel being inserted into the holding tube;

[0010] The needle retraction mechanism includes a hollow rotating cap screwed to the distal end of the holding tube, and an inner sleeve connecting the distal end of the return tube to the hollow rotating cap.

[0011] Preferably, the outer wall of the flexible sheath has scale markings indicating the insertion depth of the puncture needle.

[0012] Preferably, a sealing block is fixed to the proximal end of the grip tube.

[0013] Preferably, the near end of the grip tube has symmetrically arranged baffles.

[0014] Preferably, a hollow end cap is fixed to the inner wall of the distal end of the gripping tube.

[0015] Preferably, the ileovascular cavity has a funnel-shaped cavity that is smaller at the proximal end and larger at the distal end.

[0016] Preferably, the valve includes a sealing surface fixed to the distal end of the ileovascular bundle, and the sealing surface has multiple tightly fitting leaflets in the middle.

[0017] Preferably, the distal end of the hollow rotating cap is equipped with an elastic telescopic component for manually controlling the opening and closing of the valve. The elastic telescopic component includes a telescopic tube, a hollow button, and a return spring. The proximal end of the telescopic tube passes through the inner sleeve and faces the valve. The outer wall of the proximal end of the telescopic tube has a limiting ring with an outer diameter larger than the inner diameter of the inner sleeve. The distal end of the telescopic tube is fixed to the hollow button. A return spring is placed between the hollow button and the hollow rotating cap. The end face of the hollow button has an operating channel opening that communicates with the telescopic tube. A connecting hole is provided on the side of the distal end of the telescopic tube.

[0018] Preferably, the limiting ring is a detachable retaining ring.

[0019] Preferably, the hollow button has an external threaded portion on its proximal outer circumference, and the hollow rotating cap has a threaded groove on its distal end face that mates with the external threaded portion of the hollow button. The external threaded portion of the hollow button can be screwed and fixed in the threaded groove of the hollow rotating cap.

[0020] The beneficial effects of this invention are:

[0021] 1. A transparent reflux vessel is installed inside the transparent holding tube and sealed by a valve valve located at the distal end of the reflux vessel. The valve valve is normally closed, which can prevent the loss of high-pressure blood in the artery and reduce the risk of infection and exposure. The valve valve allows the guide wire or microcatheter to pass directly through without removing the puncture needle, which can reduce the operation steps and provide a stable channel for subsequent guide wire or microcatheter entry.

[0022] 2. In addition, this puncture needle utilizes a needle retraction mechanism to retract the puncture needle into a flexible sheath, ensuring that the tip of the puncture needle is not directly exposed in the blood vessel, thus preventing injury to the blood vessel wall and creating favorable conditions for not removing the puncture needle.

[0023] 3. The elastic telescopic component can quickly open and close the valve. Pressing the hollow button opens the valve, allowing the puncture needle to be connected internally and externally, facilitating direct observation of blood return during the procedure and confirming successful puncture. Releasing the hollow button quickly closes the valve, preventing blood from splashing. Attached Figure Description

[0024] Figure 1 This is a schematic diagram of the structure of the present invention.

[0025] Figure 2 This is a schematic diagram of the exploded structure of the present invention;

[0026] Figure 3 A schematic diagram of the valve in the closed state;

[0027] Figure 4 A schematic diagram of the retraction of the puncture needle into the flexible sheath;

[0028] Figure 5 This is a schematic diagram of the valve in the open position.

[0029] In the picture:

[0030] 1. Puncture assembly; 101. Holding tube; 102. Flexible sheath; 103. Puncture needle; 104. Sealing block; 105. Hollow end cap; 106. Baffle; 107. Scale markings;

[0031] 2. Valve mechanism; 201. Return vessel; 202. Valve valve; 203. Sealing surface; 204. Leaflet; 205. Trumpet-shaped cavity;

[0032] 3. Needle retraction mechanism; 301. Hollow rotating cap; 302. Inner sleeve; 303. Threaded groove;

[0033] 4. Elastic telescopic component; 401. Telescopic tube; 402. Hollow button; 403. Return spring; 404. Limiting ring; 405. Connecting hole; 406. External thread part; 407. Operating channel opening. Detailed Implementation

[0034] To facilitate a clear understanding of the technical means, creative features, objectives, and effects of this invention, the invention will be further described below in conjunction with specific illustrations.

[0035] In this article, "proximal" refers to the end closer to the patient's body, and "distal" refers to the end further away from the patient's body, i.e., the end closer to the operator. To more clearly show the internal details of this structure, the middle sections of the puncture needle and flexible sheath are omitted in the attached figures using double wavy lines. The structures in the figures are schematic diagrams and do not necessarily represent actual dimensions and proportions; they are mainly used to illustrate the structural principles.

[0036] like Figure 1 As shown, this puncture needle 103 can be used for arterial puncture, and is particularly suitable for hepatic artery chemoembolization via microcatheter injection of chemotherapy drugs and embolic agents. The puncture needle 103 includes a puncture assembly 1 for inserting into an artery, a valve mechanism 2 for closing the distal end of the puncture needle 103, and a needle retraction mechanism 3 for retracting the puncture needle 103 into a flexible sheath 102.

[0037] like Figure 2 , Figure 3 As shown, the puncture assembly 1 includes a transparent holding tube 101, a flexible sheath 102 connected to the proximal end of the holding tube 101, and a puncture needle 103 inserted into the flexible sheath 102 from the distal end of the holding tube 101. The holding tube 101 is made of transparent plastic, such as polypropylene (PP) or polycarbonate (PC). The flexible sheath 102 is a composite tube made of three layers of materials bonded together: an inner layer of highly lubricating Teflon (PTFE), a middle layer of reinforced nylon, and an outer layer of flexible polyurethane (PU). The puncture needle 103 is made of medical-grade stainless steel.

[0038] The valve mechanism 2 includes a transparent reflux vessel 201 connected to the distal end of the puncture needle 103. The reflux vessel 201 is also made of transparent plastic, such as polypropylene (PP) or polycarbonate (PC). A valve valve 202 seals the distal end of the reflux vessel 201. The valve valve 202 includes a sealing surface 203 fixed to the distal end of the reflux vessel 201. The sealing surface 203 has multiple tightly fitting leaflets 204 in its center, with the leaflets 204 facing proximally. Initially, the leaflets 204 at the proximal end of the valve valve 202 are closed. When the leaflets 204 are subjected to proximal blood pressure, they close more tightly. When a guidewire or microcatheter is inserted from the distal end of the leaflets 204, the leaflets 204 adhere tightly to the outer wall of the inserted instrument under internal blood pressure, providing a sealing effect. The valve valve 202 uses materials such as medical-grade polyurethane (PU), silicone, or expanded polytetrafluoroethylene (ePTFE) to simulate the flexibility of natural valves, forming a valve body that prevents backflow of blood. The reflux vessel 201 is inserted into the holding tube 101, and a gap is left between the reflux vessel 201 and the holding tube 101 to facilitate airflow and facilitate the smooth axial movement of the reflux vessel 201 within the holding tube 101.

[0039] The needle retraction mechanism 3 includes a hollow rotating cap 301 screwed to the distal end of the holding tube 101, and an inner sheath 302 connecting the distal end of the reflux vessel 201 to the hollow rotating cap 301. The hollow hole of the hollow rotating cap 301 provides a channel for instrument entry. At the same time, by rotating the hollow rotating cap 301, the reflux vessel 201 and the puncture needle 103 can be moved back and forth relative to the holding tube 101. Before the puncture begins, the tip of the puncture needle 103 can be extended out of the flexible sheath 102. After the puncture is confirmed to be successful, there is no need to remove the puncture needle 103. Only the hollow rotating cap 301 needs to be rotated relative to the holding tube 101, so that the hollow rotating cap 301, the reflux vessel 201 and the puncture needle 103 are retracted distally in a synchronized manner, so that the tip of the puncture needle 103 is hidden in the flexible sheath 102, preventing injury to the vessel wall.

[0040] like Figure 3 , Figure 4 As shown, taking femoral artery puncture as an example, the operating steps using this puncture needle 103 are as follows:

[0041] 1. The patient is placed in a supine position. The skin at the puncture site is routinely disinfected and covered with sterile drapes. Local infiltration anesthesia is then administered.

[0042] 2. The operator palpates the femoral artery pulsation point and selects a puncture point 1-2 cm below the inguinal ligament.

[0043] 3. Rotate the hollow rotating cap 301 to pass the tip of the puncture needle 103 through the flexible sheath 102. Hold the tube 101 and insert the puncture needle 103 vertically or at a 30-45° angle into the skin. Slowly advance the needle. If you observe arterial blood spurting back in the reflux vessel 201, it indicates that the puncture was successful.

[0044] 4. Then, the guidewire is inserted without removing the puncture needle 103. By rotating the hollow rotating cap 301 in the opposite direction, the puncture needle 103 is retracted into the flexible sheath 102. After confirming that the blood flow is unobstructed, it can be used for the insertion of microcatheters and other instruments to perform hepatic artery chemoembolization.

[0045] like Figure 1 As shown, in some embodiments, to facilitate the operator's observation of the insertion depth of the puncture needle 103, a scale mark 107 indicating the insertion depth of the puncture needle 103 is marked on the outer wall of the flexible sheath 102. The operator can use the depth indicated by the scale mark 107 to assist in the puncture process, which helps improve the success rate of the puncture.

[0046] like Figure 3 As shown, in some embodiments, after puncture, due to the high arterial blood pressure, blood flow may back through the interior of the puncture needle 103, or even the gap between the puncture needle 103 and the flexible sheath 102. Therefore, a sealing block 104, made of medical rubber, is fixed to the proximal end of the holding tube 101. During puncture, the tip of the puncture needle 103 punctures the sealing block 104, which seals the outer wall of the puncture needle 103, preventing blood from entering the interior of the holding tube 101. Simultaneously, when the needle is withdrawn, the sealing block 104 traps blood from the outer wall of the puncture needle 103 within the flexible sheath 102, preventing blood leakage and reducing the risk of infection.

[0047] like Figure 4 As shown, in some embodiments, to prevent the reflux vessel 201 and the puncture needle 103 from completely detaching from the holding tube 101, a hollow end cap 105 is fixed to the inner wall of the distal end of the holding tube 101. The hollow end cap 105 is fixed to the inner wall of the distal end of the holding tube 101 by adhesive or screwing. When the puncture needle 103 is retracted, the hollow end cap 105 blocks the reflux vessel 201 at the distal end, forming a distal limit to prevent complete detachment and affecting the subsequent insertion of guidewires and microcatheters. A gap is left between the hollow end cap 105 and the inner sheath 302 to facilitate airflow, making the reflux vessel 201 slide more smoothly within the holding tube 101.

[0048] like Figure 3 , Figure 4 As shown, in some embodiments, the reflux vessel 201 has a funnel-shaped cavity 205 that is smaller at the proximal end and larger at the distal end. After the refluxed blood enters the smaller proximal entrance of the funnel-shaped cavity 205, it can quickly fill the initial segment and be observed immediately. The larger space at the distal end serves as a blood flow buffer, prolonging the time it takes to fill the reflux vessel 201, allowing the operator to promptly close the valve 202 and prevent blood from overflowing from the open valve 202.

[0049] like Figures 2-4As shown, in some embodiments, to quickly verify whether the puncture was successful, whether there was blood return from the puncture needle 103, and to prevent excessive blood return from overflowing from the puncture needle 103, thus reducing the risk of infection, an elastic telescopic component 4 for manually controlling the opening and closing of the valve 202 is installed at the distal end of the hollow rotating cap 301. The valve 202 only opens after manual pressing; normally, the valve 202 is in a closed state. This also helps to control the amount of blood return during puncture, prevent rapid overflow of blood return, and reduce the risk of infection.

[0050] The elastic telescopic component 4 includes a telescopic tube 401, a hollow button 402, and a return spring 403. The proximal end of the telescopic tube 401 passes through the inner sleeve 302 and faces the valve 202. The outer wall of the proximal end of the telescopic tube 401 has a limiting ring 404 with an outer diameter larger than the inner diameter of the inner sleeve 302. The distal end of the telescopic tube 401 is fixed to the hollow button 402. The return spring 403 is placed between the hollow button 402 and the hollow rotating cap 301. The end face of the hollow button 402 has an operating channel opening 407 that communicates with the telescopic tube 401. A connecting hole 405 is opened on the side of the distal end of the telescopic tube 401. The limiting ring 404 is a detachable retaining ring.

[0051] Control principle of valve 202:

[0052] 1. Initial state: Under the action of the return spring 403, the hollow button 402 moves away from the far end of the hollow rotating cap 301. At this time, the telescopic tube 401 does not touch the valve 202, and the valve 202 is in the closed state.

[0053] 2. Open state: Press the hollow button 402 to overcome the elastic force of the return spring 403. The hollow button 402 drives the telescopic tube 401 to move proximally. The telescopic tube 401 moves forward to open the valve leaf 204 of the valve valve 202, so that the reflux vessel 201 and the inside of the puncture needle 103 are connected to the outside world. Maintain normal pressure so that arterial blood can flow from the puncture needle 103 into the reflux vessel 201.

[0054] 3. Release state: When the operator confirms blood return, quickly release the hollow button 402, the telescopic tube 401 moves away from the valve 202, and the valve 202 returns to the closed state to prevent blood from overflowing.

[0055] like Figure 4 As shown, in some embodiments, for ease of operation, a pair of symmetrically arranged baffles 106 are added to the proximal end of the grip tube 101.

[0056] The operator places their index and middle fingers on the proximal ends of a pair of baffles 106, and presses the hollow button 402 with their thumb. While pressing the hollow button 402, the internal blood return vessel 201 is connected to the outside through the communicating hole 405 on the distal side of the telescopic tube 401, and the blood return within the blood return vessel 201 is observed. Based on the blood return, the success of the puncture is determined. If the puncture is successful, the hollow button 402 is immediately released; if the puncture is unsuccessful, the puncture is repeated, and the hollow button 402 is pressed again to observe the blood return, until the puncture is successful, at which point the hollow button 402 is released. This method of operation can strictly control the amount of bleeding, prevent extravasation of blood return, and retain the operating channel, allowing the guidewire or microcatheter to be inserted without removing the puncture needle 103.

[0057] like Figure 3 , Figure 5 As shown, in some embodiments, the hollow button 402 has an external threaded portion 406 on the outer circumference near its proximal end, and the hollow rotating cap 301 has a threaded groove 303 on its distal end face that mates with the external threaded portion 406 of the hollow button 402. The external threaded portion 406 of the hollow button 402 can be screwed and fixed in the threaded groove 303 of the hollow rotating cap 301.

[0058] Normally open valve 202: Initially, if the external thread 406 of the hollow button 402 is screwed and fixed in the threaded groove 303 of the hollow rotating cap 301, the telescopic tube 401 remains in the open position of the valve 202, and the valve 202 is in the normally open position. The normally open position of the valve 202 allows skilled operators to quickly complete the puncture. During puncture, blood return is directly observed without pressing the hollow button 402; once blood return is normal and the puncture is successful, the hollow button 402 is quickly rotated to release it. After the hollow button 402 disengages from the threaded groove 303, it quickly springs open under the restoring force of the return spring 403, causing the valve 202 to close quickly and preventing blood leakage. The normally open position of the valve 202 facilitates rapid control of blood return and further improves puncture efficiency.

[0059] The foregoing has shown and described the basic principles, main features, and advantages of the present invention. Those skilled in the art should understand that the present invention is not limited to the above embodiments, and various changes and modifications can be made without departing from the spirit and scope of the invention, all of which fall within the scope of protection claimed by the present invention. The scope of protection of the present invention is defined by the appended claims and their equivalents.

Claims

1. A puncture needle for hepatic artery chemoembolization, characterized in that, include: The puncture assembly (1) includes a transparent holding tube (101) and a flexible sheath (102) connected to the proximal end of the holding tube (101), and a puncture needle (103) inserted into the flexible sheath (102) from the distal end of the holding tube (101). The valve mechanism (2) includes a transparent reflux vessel (201) connected to the distal end of the puncture needle (103) and a valve valve (202) that seals the distal end of the reflux vessel (201), wherein the reflux vessel (201) is inserted into the grip tube (101); The needle retraction mechanism (3) includes a hollow rotating cap (301) screwed to the distal end of the holding tube (101), and an inner sleeve (302) connecting the distal end of the return tube (201) to the hollow rotating cap (301). The hollow rotating cap (301) is equipped with an elastic telescopic component (4) for manually controlling the opening and closing of the valve (202) at its distal end. The elastic telescopic component (4) includes a telescopic tube (401), a hollow button (402), and a return spring (403). The proximal end of the telescopic tube (401) passes through the inner sleeve (302) and faces the valve (202). The outer wall of the proximal end of the telescopic tube (401) has a limiting ring (404) with an outer diameter larger than the inner diameter of the inner sleeve (302). The distal end of the telescopic tube (401) is fixed to the hollow button (402). The return spring (403) is placed between the hollow button (402) and the hollow rotating cap (301). The end face of the hollow button (402) has an operating channel opening (407) that communicates with the telescopic tube (401). The side of the distal end of the telescopic tube (401) is provided with a connecting hole (405).

2. The puncture needle for hepatic artery chemoembolization according to claim 1, characterized in that, The outer wall of the flexible sheath (102) has a scale mark (107) indicating the insertion depth of the puncture needle (103).

3. The puncture needle for hepatic artery chemoembolization according to claim 1, characterized in that, A sealing block (104) is fixed to the proximal end of the grip tube (101).

4. The puncture needle for hepatic artery chemoembolization according to claim 1, characterized in that, The grip tube (101) has symmetrically arranged baffles (106) at its proximal end.

5. The puncture needle for hepatic artery chemoembolization according to claim 1, characterized in that, A hollow end cap (105) is fixed to the inner wall of the distal end of the grip tube (101).

6. The puncture needle for hepatic artery chemoembolization according to claim 1, characterized in that, The ileovascular vessel (201) has a funnel-shaped cavity (205) that is small at the proximal end and large at the distal end.

7. The puncture needle for hepatic artery chemoembolization according to claim 1, characterized in that, The valve (202) includes a sealing surface (203) fixed at the distal end of the ileovascular tube (201), and the sealing surface (203) has multiple tightly fitting leaflets (204) in the middle.

8. The puncture needle for hepatic artery chemoembolization according to claim 1, characterized in that, The limiting ring (404) is a detachable retaining ring.

9. The puncture needle for hepatic artery chemoembolization according to claim 1, characterized in that, The hollow button (402) has an external threaded portion (406) on its near-end outer circumference, and the hollow rotating cap (301) has a threaded groove (303) on its far-end face that mates with the external threaded portion (406) of the hollow button (402). The external threaded portion (406) of the hollow button (402) can be screwed and fixed in the threaded groove (303) of the hollow rotating cap (301).

Images