A device for measuring the foramen ovale

Abstract

The utility model relates to the technical field of medical detection equipment, specifically a foramen ovale measuring device, which is used to pass through a catheter to measure the foramen ovale, and includes: a deformable rectangular wire frame and a guide rod; one end of the guide rod is connected to either side of the rectangular wire frame, and when the rectangular wire frame passes through the catheter, it extends from the connection to both ends and folds into two lines, and the rectangular wire frame recovers its deformation into a rectangular wire frame after passing through the catheter. This solution can accurately measure the size of the foramen ovale, assist doctors in selecting a closure device of appropriate size, so as to increase the success rate of the foramen ovale closure operation and reduce the physical and mental burden on patients.

Description

Technical Field

[0001] The utility model relates to the technical field of medical detection equipment, in particular to a foramen ovale measuring device. Background Art

[0002] The foramen ovale is a small hole in the septum of the left and right atria during the human fetal period. The blood of the left and right atria is connected during the fetal period. As the fetus grows and the pulmonary circulation is established, the pressure in the atria increases, forcing the thin sheet of the primary atrial septum to press on the surface of the foramen ovale, causing the foramen ovale to close. The foramen ovale is an early physiological channel of the atrial septum of the heart. Under normal circumstances, the baby will close about 2 months after birth. If it fails to fuse after 1 year old, it will form a patent foramen ovale (PFO). PFO is currently one of the most common congenital heart abnormalities in adults. In severe cases, it may cause unexplained stroke, migraine and other diseases.

[0003] PFO is generally diagnosed through cardiac ultrasound. Commonly used echocardiograms in clinical practice include transthoracic echocardiography (TTE), transesophageal echocardiography (TEE), and transcranial Doppler ultrasound (cTCD). Among them, TEE is the preferred method for diagnosing PFO. TTE is a semi-invasive examination, and the operation process is similar to gastroscopy. The ultrasound probe is inserted into the esophagus through a tube to take pictures. Its detection rate for PFO is higher than other methods. However, the foramen ovale is not a normally open through hole, but a channel hole with overlapping inner walls. When the heart beats, it may close or open due to pressure. During all TEE examinations, the probe needs to stay in the esophagus for a certain period of time, waiting for the foramen ovale to open and close in order to detect PFO. Therefore, its detection rate is not 100%, and it can only detect whether there is PFO, but cannot detect the aperture of the foramen ovale.

[0004] After PFO is detected, if treatment is required, the commonly used treatment method is foramen ovale closure surgery. A catheter is inserted into the femoral artery or vein, and a closure device is sent into the atrium with the help of the catheter. This closure device is placed at the defect site (foramen ovale) to close the foramen ovale.

[0005] The size of the occlusion device is mainly selected by the doctor based on ultrasound results and experience. An oversized occlusion device will cause a greater burden on the heart, while an oversized occlusion device will not be able to completely occlude the foramen ovale and may even fall off.

[0006] The selection of occlusion devices based solely on the doctor's personal experience may lead to deviations, which will affect the occlusion effect. In severe cases, it may be discovered during the operation that the selected occlusion device is of an inappropriate size, causing delays in the operation or even a second operation, which places a huge physical and mental burden on the patient.

[0007] Therefore, there is an urgent need for an oval foramen measuring device that can accurately measure the size of the oval foramen and assist doctors in selecting a closure device of appropriate size to increase the success rate of the oval foramen closure surgery and reduce the physical and mental burden on patients. Utility Model Content

[0008] The utility model aims to provide an oval foramen measuring device, which can accurately measure the size of the oval foramen and assist doctors in selecting a closure device of appropriate size, so as to increase the success rate of the oval foramen closure operation and reduce the physical and mental burden on patients.

[0009] The basic scheme provided by the utility model: an oval foramen measuring device, comprising: a deformable rectangular wire frame and a guide rod for passing a catheter;

[0010] One end of the guide rod is connected to any side of the rectangular wire frame, and when the rectangular wire frame passes through the catheter, it extends from the connection to both ends and folds into two lines. After passing through the catheter, the rectangular wire frame recovers its deformation and becomes a rectangular wire frame.

[0011] Beneficial effects of the basic scheme: Invasive detection of the heart is performed, a catheter enters the heart through a blood vessel, and the device is passed through the catheter and into the heart. When the rectangular wire frame passes through the catheter, it is squeezed by the catheter, deformed and extended from the connection to both ends to fold into two lines, and moves under the support and push of the guide rod, enters the heart, and restores its deformation to a rectangular wire frame after passing through the catheter;

[0012] The rectangular wire frame is moved by the guide rod and inserted into the foramen ovale to stretch the foramen ovale. If the foramen ovale is over-stretched, that is, the aperture of the foramen ovale is smaller than the side length of the rectangular wire frame (the side connected by the guide rod), the foramen ovale will squeeze the rectangular wire frame, so that the sides of the side connected by the guide rod are subjected to inward pressure, thereby being sunken inward. The distance between the two lowest points of the depression is the maximum distance between the two membrane flaps of the foramen ovale, that is, the aperture of the foramen ovale. The aperture is obtained in the captured images through various CT scans to determine the size of the foramen ovale, thereby assisting doctors in selecting a closure device of appropriate size to increase the success rate of the foramen ovale closure surgery and reduce the physical and mental burden on patients.

[0013] After the measurement is completed, the rectangular wire frame is pulled outward by the guide rod. It is squeezed by the catheter, deformed and extends from the connection to both ends to fold into two lines, and moves under the support and pulling of the guide rod and is pulled out of the body.

[0014] This program can accurately measure the size of the foramen ovale and assist doctors in selecting the appropriate size of occlusion device, thereby increasing the success rate of the foramen ovale occlusion surgery and reducing the physical and mental burden on patients.

[0015] Furthermore, one side and an opposite side of the rectangular wire frame connected to the guide rod are both provided with protrusions of preset angles, namely: a first protrusion and a second protrusion; the guide rod is connected to the sharp corner of the first protrusion.

[0016] Beneficial effect: The setting of the protrusion makes it easier for the rectangular wire frame to enter the catheter, and deformation begins from the sharp corner of the protrusion, which plays a role in guiding the deformation and facilitates the rectangular wire frame to shrink into the catheter.

[0017] Furthermore, the preset angle range is (90°, 180°).

[0018] Beneficial effect: The preset angle range of (90°, 180°) can play a better role in guiding deformation.

[0019] Furthermore, the four corners of the rectangular wireframe are passivated.

[0020] Beneficial effect: The four corners of the rectangular wire frame are passivated to prevent the four corners from piercing the inner wall, thereby increasing the safety of the device.

[0021] Furthermore, the guide rod and the rectangular wire frame are movably connected, the rectangular wire frame is fixedly connected with a first buckle, one end of the guide rod is fixedly connected with a second buckle, and the first buckle and the second buckle are nested to form a double buckle;

[0022] And the first ring buckle and the rectangular wire frame are in the same plane.

[0023] Beneficial effects: The guide rod and the rectangular wire frame are movably connected, so that the rectangular wire frame can be adjusted to the internal structure of the heart and provide reasonable support for the foramen ovale.

[0024] Whether the CT scan is parallel to the rectangular wireframe will affect the accuracy of the final aperture of the oval foramen. This is because if the CT scan is not parallel to the rectangular wireframe, the distance between the two lowest points of the depressions in the rectangular wireframe in the captured image is not the actual maximum distance and cannot accurately represent the aperture of the oval foramen. Therefore, a first ring buckle is set as a reference. In the captured image, based on whether the size of the first ring buckle is the actual size, it can be determined whether the captured image is taken when the CT scan and the rectangular wireframe are parallel. If so, the distance between the two lowest points of the depressions in the rectangular wireframe is obtained as the aperture. If not, the CT scan can be adjusted accordingly.

[0025] Furthermore, the first ring buckle and the second ring buckle are in the shape of a rectangle or a diamond.

[0026] Beneficial effect: The shapes of the first ring buckle and the second ring buckle are: rectangle or diamond. According to the diagonal length recognized in the image and the actual diagonal length, it can be judged whether the image is taken by CT and when the rectangular wire frame is parallel.

[0027] Furthermore, the rectangular wire frame and the first ring buckle are made by bending a memory alloy wire;

[0028] Or the rectangular wire frame is made by bending a memory alloy wire;

[0029] The first ring buckle is made by bending a steel wire;

[0030] The two ends of the memory alloy wire are overlapped and fixedly connected with the two ends of the steel wire.

[0031] Beneficial effects: The memory alloy wire is easy to deform and recover, and the two ends of the memory alloy wire overlap and are fixedly connected with the two ends of the steel wire, thereby increasing the stability of the connection.

[0032] Furthermore, the side length of the rectangular frame ranges from [30, 40] mm.

[0033] Beneficial effect: The side length of the rectangular frame ranges from [30,40] mm and can accommodate oval holes of various sizes.

[0034] Furthermore, a metal wire is wound around the guide rod.

[0035] Beneficial effect: The guide rod is wound with metal wire to enhance the durability of the guide rod. BRIEF DESCRIPTION OF THE DRAWINGS

[0036] Figure 1 This is a schematic structural diagram of an embodiment of an oval foramen measuring device of the utility model;

[0037] Figure 2 It is a schematic diagram of the structure of a rectangular wireframe in an embodiment of an oval foramen measuring device of the utility model;

[0038] Figure 3 It is a dimensioning diagram of a rectangular wireframe in an embodiment of an oval foramen measuring device of the utility model;

[0039] Figure 4 This is a schematic structural diagram of an embodiment of an oval foramen measuring device of the utility model in which a rectangular wire frame without a protrusion is provided;

[0040] Figure 5 It is a structural schematic diagram of a rectangular wireframe rounding process in an embodiment of an oval foramen measuring device of the utility model;

[0041] Figure 6 It is a structural schematic diagram of a rectangular wire frame without passivation treatment in an embodiment of an oval foramen measuring device of the utility model;

[0042] Figure 7 This is a structural dimension marking diagram of an embodiment of an oval foramen measuring device of the utility model;

[0043] Figure 8 It is a schematic diagram of a rectangular wire frame folded in a catheter in an embodiment of an oval foramen measuring device of the utility model;

[0044] Fig. 9It is a schematic diagram of an oval foramen punctum extruded rectangular wireframe in an embodiment of an oval foramen punctum measuring device of the utility model. DETAILED DESCRIPTION

[0045] The following is further described in detail through specific implementation methods:

[0046] The reference numerals in the drawings of the specification include: a rectangular wire frame 1 , a guide rod 2 , a first protrusion 3 , a second protrusion 4 , a first ring buckle 5 , a second ring buckle 6 , and a metal wire 7 .

[0047] In the description of this application, unless otherwise clearly specified and limited, the terms "first" and "second" are used for descriptive purposes only and cannot be understood as indicating or implying relative importance; unless otherwise specified or explained, the term "plurality" refers to two or more; the terms "connected" and "fixed" should be understood in a broad sense, for example, "connected" can be a fixed connection, a detachable connection, an integral connection, or an electrical connection; it can be directly connected or indirectly connected through an intermediate medium. For ordinary technicians in this field, the specific meanings of the above terms in this application can be understood according to specific circumstances.

[0048] In the description of this specification, it should be understood that the directional words such as "upper", "lower", "left", and "right" described in the embodiments of the present application are described at the angles shown in the accompanying drawings and should not be understood as limitations on the embodiments of the present application. In addition, in the context, it should also be understood that when it is mentioned that an element is connected to the "upper", "lower", "left", or "right" of another element, it can not only be directly connected to the "upper", "lower", "left", or "right" of another element, but can also be indirectly connected to the "upper", "lower", "left", or "right" of another element through an intermediate element.

[0049] Embodiment 1

[0050] The embodiment is basically as shown in the attached Figure 1 As shown: an oval foramen measuring device, used to pass through a catheter to measure the oval foramen, comprising: a deformable rectangular wire frame 1 and a guide rod 2;

[0051] One end of the guide rod 2 is connected to any side of the rectangular wire frame 1, and the guide rod 2 and the rectangular wire frame 1 are movably connected. In this embodiment, the rectangular wire frame 1 and the guide rod 2 are movably connected by a buckle, and other embodiments may adopt hinged connection, rotation connection, etc.

[0052] Specifically, Figure 2 As shown, the side where the rectangular wire frame 1 is connected to the guide rod 2 and the opposite side are both provided with protrusions of preset angles, namely: a first protrusion 3 and a second protrusion 4; wherein the preset angle range is (90°, 180°), and the preset angle in this embodiment is 120°, as shown in FIG. Figure 3 As shown;

[0053] The guide rod 2 is connected to the sharp corner of the first protrusion 3, including: a first buckle 5 is fixedly connected to the sharp corner of the first protrusion 3, a second buckle 6 is fixedly connected to one end of the guide rod 2, the first buckle 5 and the second buckle 6 are nested to form a double buckle, and the fixed connection in this embodiment is welding; and the first buckle 5 and the rectangular wire frame 1 are in the same plane; wherein the shape of the first buckle 5 and the second buckle 6 is: rectangle or rhombus; in this embodiment, the shape of the first buckle 5 and the second buckle 6 is rectangle; one corner of the first buckle 5 is fixedly connected to the sharp corner of the first protrusion 3; in other embodiments, the protrusion may not be provided, and one corner of the first buckle 5 is directly fixedly connected to the rectangular wire frame 1, and one corner of the second buckle 6 is fixedly connected to one end of the guide rod 2, and the first buckle 5 and the second buckle 6 are nested to form a double buckle, such as Figure 4 As shown;

[0054] The rectangular wire frame 1 and the first ring buckle 5 are made of a bent memory alloy wire, such as a nickel alloy, and the middle connection between the rectangular wire frame 1 and the first ring buckle 5 is die-cast as a cylinder; in other embodiments, the rectangular wire frame 1 is made of a bent memory alloy wire; the first ring buckle 5 and the second ring buckle 6 are respectively made of a bent steel wire; the two ends of the memory alloy wire overlap and are fixedly connected with the two ends of the steel wire.

[0055] In this embodiment, a memory alloy wire with a diameter of 0.014 inches is bent to form a rectangular wire frame 1 and a first ring buckle 5; specifically, a memory alloy cylindrical steel wire is used, and the side length of the rectangular frame ranges from [30,40] mm, and the side length in this embodiment is 30 mm; the first protrusion 3 and the second protrusion 4 are symmetrical, the bottom side length of the first protrusion 3 is 10 mm, and the straight-line distance between its lowest point and the adjacent side is 10 mm; the middle connection between the rectangular wire frame 1 and the first ring buckle 5 is die-cast as a cylinder with a diameter of 1.5 mm and a length of 3 mm.

[0056] The four corners of the rectangular wireframe 1 are passivated corners. The passivation treatment may be chamfering or rounding. In this embodiment, chamfering is adopted. The angle range of the chamfering is 2-4°, and in this embodiment, it is 4°. In other embodiments, the four corners of the rectangular wireframe 1 are rounded, such as Figure 5 As shown, or no passivation treatment is required, such as Figure 6 As shown;

[0057] The guide rod 2 and the second ring buckle 6 are made of a bent metal, and a metal wire 7 is wound on the guide rod 2. Specifically, a 0.14-inch stainless steel wire is folded in a "G" shape and spirally wound on the guide rod 2. After winding, the diameter of the guide rod 2 and the metal wire 7 together does not exceed 1.5mm; and the two ends are welded to the two ends of the guide rod 2. Specifically, the top single guide wire square ring neck has three guide wires spirally wound and die-cast and fixed, and the tail three guide wires spirally wound and die-cast and fixed. After die-casting, the diameter does not exceed 1.5mm, the die-casting length is 3mm, and the total rod length is 1200mm. Figure 7 shown.

[0058] When the rectangular wire frame 1 passes through the catheter, it extends from the connection point to both ends and folds into two lines, such as Figure 8 As shown, the rectangular wire frame 1 recovers its deformation into the rectangular wire frame 1 after passing through the catheter.

[0059] The specific implementation process is as follows: an invasive detection is performed on the heart, a catheter enters the heart through a blood vessel, and the device is passed through the catheter and enters the heart, wherein the rectangular wire frame 1 is squeezed by the catheter when passing through the catheter, deforms and extends from the connection to both ends to fold into two lines, and moves under the support and push of the guide rod 2, enters the heart, and restores its deformation to the rectangular wire frame 1 after passing through the catheter;

[0060] The rectangular wire frame 1 is moved by the guide rod 2 and inserted into the oval foramen to expand the oval foramen; and if the oval foramen is over-expanded, that is, the aperture of the oval foramen is smaller than the side length of the rectangular wire frame 1 (the side connected to the guide rod 2), the oval foramen will squeeze the rectangular wire frame 1, so that the sides of the side connected to the guide rod 2 are subjected to inward pressure, thereby concave inward, such as Fig. 9 As shown, the distance between the two lowest points of the depressions is the maximum distance between the two membrane flaps of the oval foramen, that is, the aperture of the oval foramen. Through various CT scans, in the captured image, according to whether the size of the first ring buckle 5 is the actual size (the diagonal length in the image is consistent with the actual diagonal length), it can be judged whether the captured image is taken when the CT scan and the rectangular wire frame 1 are parallel. If so, the distance between the two lowest points of the depressions of the rectangular wire frame 1 is obtained as the aperture. If not, the CT scan can be adjusted accordingly or the device can be adjusted accordingly until the size of the first ring buckle 5 in the captured image is the actual size, thereby determining the size of the oval foramen, and then assisting the doctor in selecting a closure device of a suitable size to increase the success rate of the oval foramen closure surgery and reduce the physical and mental burden on the patient.

[0061] After the measurement is completed, the rectangular wire frame 1 is pulled outward by the guide rod 2, and the sharp corners of the first protrusion 3 are stressed and squeezed into the catheter. The rectangular wire frame 1 gradually deforms and extends from the connection to the two ends to fold into two lines, and moves under the support and pulling of the guide rod 2 and is pulled out of the body. This solution can accurately measure the size of the foramen ovale, assist doctors in selecting the appropriate size of the occlusion device, so as to increase the success rate of the foramen ovale occlusion surgery and reduce the physical and mental burden on patients.

[0062] The above is only an embodiment of the utility model. The common sense such as the known specific structure and characteristics in the scheme is not described in detail here. The ordinary technicians in the relevant field know all the common technical knowledge in the technical field of the utility model before the application date or priority date, can obtain all the existing technologies in the field, and have the ability to apply the conventional experimental means before that date. The ordinary technicians in the relevant field can improve and implement this scheme in combination with their own abilities under the enlightenment given by this application. Some typical known structures or known methods should not become obstacles for ordinary technicians in the relevant field to implement this application. It should be pointed out that for the technicians in this field, without departing from the structure of the utility model, several deformations and improvements can be made, which should also be regarded as the protection scope of the utility model, which will not affect the effect of the implementation of the utility model and the practicality of the patent. The protection scope required by this application shall be based on the content of its claims, and the specific implementation methods and other records in the specification can be used to explain the content of the claims.

Claims

1. A foramen ovale measuring device, characterized in that: include: a deformable rectangular wire frame and guide rods for passing through the catheter; One end of the guide rod is connected to any side of the rectangular wire frame, and when the rectangular wire frame passes through the catheter, it extends from the connection to both ends and folds into two lines. After passing through the catheter, the rectangular wire frame recovers its deformation and becomes a rectangular wire frame.

2. The foramen ovale measuring device according to claim 1, characterized in that: The side where the rectangular wire frame is connected to the guide rod and the opposite side are both provided with protrusions with preset angles, which are respectively: a first protrusion and a second protrusion; the guide rod is connected to the sharp corner of the first protrusion.

3. The foramen ovale measuring device according to claim 2, characterized in that: The preset angle range is (90°, 180°).

4. The foramen ovale measuring device according to claim 1, characterized in that: The four corners of the rectangular wireframe are passivated.

5. The foramen ovale measuring device according to claim 1, characterized in that: The guide rod is movably connected to the rectangular wire frame, the rectangular wire frame is fixedly connected to a first ring buckle, one end of the guide rod is fixedly connected to a second ring buckle, the first ring buckle and the second ring buckle are nested to form a double ring buckle; And the first ring buckle and the rectangular wire frame are in the same plane.

6. The foramen ovale measuring device according to claim 5, characterized in that: The shapes of the first ring buckle and the second ring buckle are: rectangle or diamond.

7. The foramen ovale measuring device according to claim 1, characterized in that: The rectangular wire frame and the first ring buckle are made by bending a memory alloy wire; Or the rectangular wire frame is made by bending a memory alloy wire; The first ring buckle is made by bending a steel wire; The two ends of the memory alloy wire are overlapped and fixedly connected with the two ends of the steel wire.

8. The foramen ovale measuring device according to claim 1, characterized in that: The side length of the rectangular wireframe is in the range of [30,40] mm.

9. The foramen ovale measuring device according to claim 1, characterized in that: Metal wire is wound around the guide rod.

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