Plugging device for femoral artery pseudoaneurysm and operation method thereof

Abstract

The invention relates to the technical field of medical instruments, in particular to a plugging device for femoral artery pseudoaneurysm and an operation method of the plugging device. The plugging device comprises a sheathing canal assembly, an air bag assembly and a thrombin conveying assembly, and the air bag assembly and the thrombin conveying assembly are arranged in the sheathing canal assembly; the air bag assembly comprises an air bag body and an inflation tube. The inflation tube penetrates through the air bag body and is communicated with the air bag body; the air bag assembly can move in the axial direction of the sheathing canal assembly and is inflated and expanded after the air bag body extends out of the head end of the sheathing canal assembly. The thrombin conveying assembly can eject thrombin through the head end of the sheath tube assembly. Compared with non-invasive compression, through the design of the high-compliance air bag, flexible plugging of the tumor neck and self-adaption to the shape and the size of the tumor neck, the pain feeling of a patient is effectively relieved, the sealing effect is enhanced, and the operation requirements for the thrombin injection speed and the dose precision are reduced. After the air bag body seals the tumor neck, a small amount of thrombin can be injected into the tumor body, and therefore the risk that the thrombin escapes to the femoral artery is avoided.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a closure device for femoral artery pseudoaneurysm and an operating method thereof. Background Art

[0002] Femoral artery pseudoaneurysm is a common complication of interventional procedures. It forms a pulsatile hematoma due to damage to the vessel wall, with an incidence of 0.5% and 8% during diagnostic and interventional cardiac catheterization, respectively. It can lead to persistent groin pain and swelling, compressive neuropathy, limb ischemia, skin necrosis, and even sudden rupture. Studies have shown that this complication not only prolongs hospitalization and increases medical costs, but is also significantly associated with an increased risk of long-term myocardial infarction and sudden death. Sudden rupture is a more direct threat to patients' lives, making the treatment of pseudoaneurysms of great clinical significance.

[0003] While existing interventions (such as surgical repair, ultrasound-guided compression, and thrombin injection) can partially alleviate symptoms, they all have significant drawbacks: surgical repair has a complication rate as high as 20%, and noninvasive compression therapy requires prolonged compression and immobilization, causing pain and discomfort. Compression effectiveness can be suboptimal, particularly in obese patients (those with larger pseudoaneurysms or wide necks) or inexperienced operators (medical personnel), and success rates are significantly affected by operator experience and patient tolerance.

[0004] Secondly, while thrombin injection is effective, it can escape into the femoral artery, leading to distal arterial embolism. The success rate is low for larger pseudoaneurysms or those with wide necks. The injection rate and dosage must be strictly controlled during the procedure, otherwise complications may occur and the procedure is difficult. Summary of the Invention

[0005] (1) Technical issues to be resolved

[0006] In view of the above-mentioned shortcomings and deficiencies of the prior art, the present invention provides a closure device for femoral artery pseudoaneurysm and an operating method thereof, which solves the technical problems of poor non-invasive compression effect and high difficulty in thrombin injection operation for pseudoaneurysms with larger tumor bodies or wider tumor necks.

[0007] (2) Technical solution

[0008] In order to achieve the above-mentioned object, the occlusion device for femoral artery pseudoaneurysm of the present invention comprises a sheath assembly, and a balloon assembly and a thrombin delivery assembly built into the sheath assembly;

[0009] The airbag assembly includes an airbag body and an inflation tube; the inflation tube passes through the airbag body and the two are connected; the airbag assembly can move along the axial direction of the sheath assembly and inflate after the airbag body extends out of the head end of the sheath assembly;

[0010] The thrombin delivery component is capable of ejecting thrombin through the tip of the sheath component.

[0011] Optionally, an anti-slip puncture needle is provided on the outer wall of the airbag body.

[0012] Optionally, the airbag assembly further comprises a traction wire;

[0013] The traction wire is built into the inflation tube.

[0014] Optionally, the thrombin delivery assembly includes a delivery tube and a nozzle;

[0015] The delivery tube is built into the sheath tube assembly;

[0016] The nozzle is in communication with the delivery tube and is disposed at the head end of the sheath tube assembly;

[0017] The nozzle is provided with a plurality of nozzles; the plurality of nozzles spray thrombin radially.

[0018] Optionally, the spraying angle of the axis of the nozzle relative to the plane where the tumor neck is located is 30° to 45°.

[0019] Optionally, the sheath assembly includes a flexible tube body and an operating handle;

[0020] The tail end of the flexible tube is connected to the operating handle, and the head end is connected to the airbag assembly in a sliding manner along the axial direction of the flexible tube;

[0021] The head end of the flexible pipe body is in a truncated cone shape.

[0022] Optionally, the operating handle is integrated with an airbag pressure control unit and a thrombin injection switch.

[0023] Optionally, the airbag body is a compliant balloon made of polyurethane.

[0024] Optionally, the airbag is fusiform in an expanded state.

[0025] Furthermore, the present invention also provides an operating method for a closure device for a femoral artery pseudoaneurysm. The operating method for a closure device for a femoral artery pseudoaneurysm is implemented based on the above-mentioned closure device for a femoral artery pseudoaneurysm, and the operating method comprises:

[0026] Puncture the tip of the sheath assembly into the interior of the femoral artery pseudoaneurysm;

[0027] Pushing the airbag assembly to move along the axial direction of the sheath assembly until the airbag moves to the tumor neck;

[0028] The inflation tube is inflated to expand the air bag and block the tumor neck;

[0029] The thrombin delivery component sprays thrombin into the tumor cavity.

[0030] (3) Beneficial effects

[0031] The beneficial effects of the present invention are:

[0032] The inflation tube is inflated, and the balloon expands and seals the tumor neck, thereby achieving the effect of sealing the tumor neck. Compared with non-invasive compression (instrumental compression), this device uses a highly compliant balloon design to flexibly seal the tumor neck and adapt to the shape and size of the tumor neck, effectively alleviating the patient's pain, enhancing the sealing effect, and reducing the operational requirements for thrombin injection speed and dosage accuracy. After the balloon seals the tumor neck, a small amount of thrombin can be injected into the tumor, thereby avoiding the risk of thrombin escaping to the femoral artery and effectively preventing thrombin extravasation from causing extensive thrombosis. BRIEF DESCRIPTION OF THE DRAWINGS

[0033] Figure 1 Schematic diagram of the structure of the occlusion device for femoral artery pseudoaneurysm of the present invention;

[0034] Figure 2 Schematic diagram of the internal structure of the occluding device for femoral artery pseudoaneurysm of the present invention;

[0035] Figure 3 is an exploded schematic diagram of the airbag assembly of the present invention;

[0036] Figure 4 Schematic diagram of the structure of the thrombin delivery assembly of the present invention;

[0037] Figure 5 This is a schematic diagram of the state of the occlusion device for femoral artery pseudoaneurysm of the present invention during puncture.

[0038] [Description of Reference Numerals]

[0039] 101: flexible tube body; 102: operating handle; 103: head end of sheath assembly;

[0040] 201: airbag body; 202: inflation tube; 203: anti-slip puncture needle;

[0041] 301: delivery pipe; 302: nozzle. DETAILED DESCRIPTION

[0042] In order to better explain the present invention and facilitate understanding, the present invention is described in detail below through specific implementation methods in conjunction with the accompanying drawings.

[0043] It should be noted that all directional indications in the embodiments of the present invention (such as up, down, left, right, front, back, etc.) are only used to explain the relative position relationship, movement status, etc. between the various components under a certain specific posture (as shown in the accompanying drawings). If the specific posture changes, the directional indication will also change accordingly.

[0044] In addition, the terms "first," "second," and so on, used in this disclosure are for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of the technical features being referenced. Thus, a feature specified as "first" or "second" may explicitly or implicitly include at least one such feature. In the description of this disclosure, "plurality" means at least two, such as two or three, unless otherwise specifically defined.

[0045] In the present invention, unless otherwise specified or limited, the terms "connect," "fix," etc. should be understood in a broad sense. For example, "fix" can mean fixed connection, detachable connection, or integration; "connection" can mean mechanical connection or electrical connection; it can mean direct connection or indirect connection through an intermediate medium; it can mean internal communication between two elements or interaction between two elements, unless otherwise specified. Those skilled in the art will understand the specific meanings of the above terms in the present invention based on specific circumstances.

[0046] See also Figure 1 、 Figure 2 and Figure 5 The present invention provides a closure device for femoral artery pseudoaneurysm, comprising a sheath assembly, an airbag assembly and a thrombin delivery assembly built into the sheath assembly; the airbag assembly comprising an airbag body 201 and an inflation tube 202; the inflation tube 202 passing through the airbag body 201 and being in communication with the airbag body 201; the airbag assembly capable of moving axially along the sheath assembly and inflating after the airbag body 201 extends beyond the head end 103 of the sheath assembly; and the thrombin delivery assembly capable of ejecting thrombin through the head end 103 of the sheath assembly. The head end 103 of the sheath assembly is a puncture end, which is conical or truncated cone-shaped and has an outer diameter smaller than that of the tail end of the sheath assembly.

[0047] The balloon body 201 is in a non-working state, i.e., a contracted state. In this state, the balloon body 201 can penetrate or pass through the head end 103 of the sheath assembly, making it easy to store. When penetrating, the balloon assembly punctures along with the sheath assembly, ensuring puncture strength. After the head end 103 of the sheath assembly punctures the tumor (tumor cavity), the balloon body 201 is passed out and then inflated. The balloon body 201 enters a working state, i.e., an expanded state, so that the balloon body 201 can block the tumor neck and separate the tumor from the femoral artery. In this state, the injected thrombin is blocked by the balloon body 201 and therefore does not flow into the femoral artery. This not only reduces the operational requirements for injection speed and dosage accuracy, but also effectively avoids or reduces the risk of distal arterial embolism.

[0048] By using a small-caliber short sheath to puncture the pseudoaneurysm and placing a short electrode in the tumor body or femoral vein, the short electrode is used to detect the position of the tumor neck or the contact with the blood vessel wall to ensure the precise placement of the balloon 201. The inflation tube 202 is inflated, and the balloon 201 expands and seals the tumor neck, thereby achieving the effect of sealing the tumor neck. Compared with non-invasive compression (instrument compression), this device uses a high-compliance balloon design to flexibly seal the tumor neck and adapt to the shape and size of the tumor neck, effectively alleviating the patient's pain and enhancing the sealing effect. After the balloon 201 seals the tumor neck, a small amount of thrombin can be injected into the tumor body to avoid the risk of thrombin escaping to the femoral artery, effectively preventing thrombin extravasation from causing extensive thrombosis. Among them, the short electrode is withdrawn together with the sheath assembly after completing the balloon 201 sealing and thrombin injection.

[0049] like Figure 3 As shown, the outer wall of the balloon 201 is provided with anti-slip puncture needles 203. In this embodiment, the anti-slip puncture needles 203 are micro-puncture structures, namely, multiple puncture needles or protrusions arranged on the outer wall of the balloon 201. The anti-slip puncture needles 203 abut against the tumor neck, ensuring stable anchoring of the balloon 201 even in thick fat layers. Therefore, this device has significant clinical application value in special populations (such as obese patients).

[0050] Furthermore, the balloon assembly includes a traction wire, which is embedded in the inflation tube 202. The traction wire is used to pull the balloon assembly along the axial direction of the sheath assembly, precisely moving the balloon body 201 to the aneurysm neck. Of course, the traction wire can also be omitted, and traction can be achieved directly through the inflation tube 202. The inflation tube 202 is a single, integrated tube, which provides a better traction effect on the balloon assembly than two inflation tubes 202 connected to each end of the balloon body 201.

[0051] See also Figure 4The thrombin delivery assembly includes a delivery tube 301 and a nozzle 302; the delivery tube 301 is built into the sheath assembly; the nozzle 302 is connected to the delivery tube 301 and is disposed at the head end 103 of the sheath assembly; the nozzle 302 is provided with multiple nozzles; the multiple nozzles radially spray thrombin. Specifically, the number of nozzles is 4-6, the aperture is 0.2±0.05mm, and the axial spacing between adjacent nozzles is 1.5±0.5mm. After passing through the delivery tube 301, the thrombin is sprayed from the nozzles of the nozzle 302, allowing the thrombin to act within the tumor. The multiple nozzles radially spray thrombin, allowing the thrombin to be sprayed into the tumor quickly and evenly.

[0052] Secondly, the spray angle θ of the axis of the nozzle 302 relative to the plane where the tumor neck is located is 30° to 45°. In this embodiment, the axis of the nozzle 302 is parallel to the axis of the sheath assembly, and the sheath assembly obliquely punctures the tumor. The spray angle of 30° to 45° oblique to the proximal end can adjust the flow direction of thrombin accordingly, avoiding the nozzle 302 facing the tumor neck, thereby effectively preventing thrombin from flowing back and reducing the risk of thrombin escaping to the femoral artery. After the balloon body 201 blocks the tumor neck, a small amount of thrombin is injected into the tumor cavity through the delivery tube 301. The precise distribution characteristics of multiple nozzles 302 are utilized to control the flow direction of thrombin, ensuring that thrombin only acts in the tumor cavity, and avoiding it from entering the femoral artery and causing extensive thrombosis.

[0053] The sheath assembly includes a flexible tube body 101 and an operating handle 102. The tail end of the flexible tube body 101 is connected to the operating handle 102, and the head end is slidably connected to the airbag assembly along the axial direction of the flexible tube body 101. The head end of the flexible tube body 101 is truncated cone-shaped. In this embodiment, the diameter of the flexible tube body 101 is 3F-5F, and the total length is 12±2cm. The outer diameter of the head end 103 of the sheath assembly (i.e., the tip of the flexible tube body 101) is ≤2.3mm, and the head end 103 of the sheath assembly must be sealed. The short length of the flexible tube body 101 facilitates precise positioning and reduces operational difficulty. The ultra-thin outer diameter significantly reduces puncture trauma and improves patient comfort. The tail end of the flexible tube body 101 is a handheld end, on which the operating handle 102 is disposed. The truncated cone-shaped head end further enhances the puncture efficiency of the sheath assembly. Due to the retractable nature of the airbag assembly, the head end of the flexible tube body 101 can be made very small, thereby improving puncture efficiency. Optionally, the head end of the flexible tube body 101 is equipped with an axial bending adjustment mechanism, which is controlled by the operating handle 102 so that the head end of the flexible tube body 101 can be bent at a certain angle, thereby improving the flexibility of the sheath assembly during puncture.

[0054] The operating handle 102 integrates an airbag pressure control unit and a thrombin injection switch. The airbag pressure control unit controls the squeezing force of the airbag 201 on the tumor neck, preventing excessive or insufficient squeezing force, reducing patient discomfort, and ensuring the effective sealing of the tumor neck by the airbag 201. The thrombin injection switch opens or closes the thrombin injection channel, which allows thrombin to flow through the delivery tube 301, acting like a valve.

[0055] Optionally, the balloon body 201 is a compliant balloon made of polyurethane, with a nominal bursting pressure of ≥6 atm and a working pressure range of 2-4 atm. The height of the anti-slip puncture needles 203 can be 0.1-0.3 mm, with a density of 15-20 pcs / cm 2 This structure enables the balloon body 201 to fully fit the shape of the tumor neck and achieve effective sealing.

[0056] In addition, the balloon 201 is fusiform in the expanded state. The fusiform is a deflated and elongated shape that facilitates the balloon 201 to pass into or out of the head end of the flexible tube 101 in the deflated state. In the expanded state, the fusiform has a longer axial dimension, which makes it more adaptable to occluding tumor necks of different axial dimensions and provides a better sealing effect.

[0057] In addition, the present invention further provides an operating method for a closure device for a femoral artery pseudoaneurysm. The operating method for a closure device for a femoral artery pseudoaneurysm is based on the above-mentioned closure device for a femoral artery pseudoaneurysm and includes:

[0058] Puncture the tip end 103 of the sheath assembly obliquely into the interior of the femoral artery pseudoaneurysm;

[0059] Push the air balloon assembly to move along the axial direction of the sheath assembly until the air balloon body 201 moves to the tumor neck;

[0060] The inflation tube 202 is inflated to expand the balloon 201 and block the tumor neck;

[0061] The thrombin delivery component sprays thrombin into the tumor cavity.

[0062] The occlusion device of this invention punctures the pseudoaneurysm with a short, small-caliber sheath and seals the aneurysm neck with a highly compliant annular balloon. This eliminates the need for prolonged compression, improves patient comfort, and offers significant clinical value. Furthermore, the device can inject a small amount of thrombin into the aneurysm after balloon closure, effectively preventing thrombin extravasation into the femoral artery and widespread thrombosis, further enhancing the safety and effectiveness of treatment.

[0063] It should be understood that the above description of the specific embodiments of the present invention is merely for the purpose of illustrating the technical approach and features of the present invention. Its purpose is to enable those skilled in the art to understand the contents of the present invention and implement them accordingly. However, the present invention is not limited to the above-described specific embodiments. Any changes or modifications made within the scope of the claims of the present invention are intended to be covered by the scope of protection of the present invention.

Claims

1. A closure device for femoral artery pseudoaneurysm, characterized in that: The occlusion device includes a sheath assembly, an airbag assembly built into the sheath assembly, and a thrombin delivery assembly; The airbag assembly comprises an airbag body (201) and an inflation tube (202); the inflation tube (202) passes through the airbag body (201), and the two are in communication; the airbag assembly is capable of moving along the axial direction of the sheath tube assembly, and is inflated after the airbag body (201) extends out of the head end (103) of the sheath tube assembly; The thrombin delivery component is capable of ejecting thrombin through the tip end (103) of the sheath component.

2. The occlusion device for femoral artery pseudoaneurysm according to claim 1, characterized in that: An anti-slip puncture needle (203) is provided on the outer wall of the airbag body (201).

3. The occlusion device for femoral artery pseudoaneurysm according to claim 1, characterized in that: The airbag assembly further includes a traction wire; The traction wire is built into the inflation tube (202).

4. The occlusion device for femoral artery pseudoaneurysm according to any one of claims 1 to 3, characterized in that: The thrombin delivery assembly includes a delivery tube (301) and a nozzle (302); The delivery tube (301) is built into the sheath tube assembly; The nozzle (302) is in communication with the delivery tube (301) and is disposed at the head end (103) of the sheath tube assembly; The nozzle (302) is provided with a plurality of nozzles; the plurality of nozzles spray thrombin radially.

5. The occlusion device for femoral artery pseudoaneurysm according to claim 4, characterized in that: The spraying angle of the axis of the nozzle (302) relative to the plane where the tumor neck is located is 30° to 45°.

6. The occlusion device for femoral artery pseudoaneurysm according to any one of claims 1 to 3, characterized in that: The sheath tube assembly comprises a flexible tube body (101) and an operating handle (102); The tail end of the flexible tube body (101) is connected to the operating handle (102), and the head end is slidably connected to the airbag assembly along the axial direction of the flexible tube body (101); The head end of the flexible pipe body (101) is in a truncated cone shape.

7. The occlusion device for femoral artery pseudoaneurysm according to claim 6, characterized in that: The operating handle (102) is integrated with an airbag pressure control unit and a thrombin injection switch.

8. The occlusion device for femoral artery pseudoaneurysm according to any one of claims 1 to 3, characterized in that: The airbag body (201) is a compliant balloon made of polyurethane.

9. The occlusion device for femoral artery pseudoaneurysm according to any one of claims 1 to 3, characterized in that: The airbag body (201) is in a spindle shape when in an expanded state.

10. A method for operating a closure device for a femoral artery pseudoaneurysm, characterized in that: The operating method of the occluding device for femoral artery pseudoaneurysm is implemented based on the occluding device for femoral artery pseudoaneurysm according to any one of claims 1 to 9, and the operating method comprises: Puncture the tip end (103) of the sheath assembly into the interior of the femoral artery pseudoaneurysm; Pushing the airbag assembly to move along the axial direction of the sheath assembly until the airbag body (201) moves to the tumor neck; The inflation tube (202) is inflated to expand the air bag (201) and block the tumor neck; The thrombin delivery component sprays thrombin into the tumor cavity.

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