CN114869425A - A novel foramen ovale opening device for pulmonary hypertension - Google Patents

Abstract

The present invention provides a novel foramen ovale opening device for pulmonary arterial hypertension, aiming at the special treatment needs of patients with pulmonary arterial hypertension, it is expected to reopen the foramen ovale, so on the basis of the existing mature technology of placing an occluder through PFO It overcomes the completely closed design of the existing PFO occluder, which is not suitable for the opening requirements of pulmonary hypertension; at the same time, it combines the use of the existing balloon atrial septostomy to open the channels on both sides of the left and right atria to achieve the purpose of decompression. It overcomes the disadvantages of the latter, such as many side effects, additional trauma, high cost, failure of self-regrowth and closure. Therefore, it is safe, simple, cost-effective and long-term to keep the left and right atrial channels open, treat pulmonary hypertension, and protect cardiac function.

Description

A novel foramen ovale opening device for pulmonary hypertension

technical field

The invention belongs to the technical field of medical devices, and in particular relates to a novel foramen ovale opening device for pulmonary hypertension.

Background technique

Pulmonary hypertension (PH) is a group of malignant pulmonary vascular diseases caused by elevated pulmonary artery pressure and pulmonary vascular pulmonary resistance followed by progressive increase in right heart load leading to right heart failure. According to the registry data of the National Institutes of Health, the mortality rate of PH was 32% in the first year after diagnosis, and rose to 52% and 66% in the second and fifth years, respectively. ～Death within 3 years; even after successful lung transplantation or combined heart-lung transplantation, the 3-year and 5-year survival rates are only 55% and 45%, and even after standard treatment with existing drugs, there are still about half The patient died within 7 years and was hailed as a "cancer" in cardiovascular disease. The research on its new therapeutic drugs, devices and methods has always been a hot spot and focus in the field of cardiopulmonary vascular research.

The foramen ovale is a physiological channel in the embryonic period of the cardiac atrial septum. About 5 to 7 months after birth, the secondary and primary septa of most people adhere to each other and fuse to form a permanent atrial septum. The patent foramen ovale (PFO) is formed. About 25% to 34% of normal adults have incomplete fusion of the two septa in the fossa ovalis, leaving a permanent crack-like defect. This fissure is like a portal shaft or valve and can only open when the pressure on the right side is greater than that on the left side. Therefore, the PFO is not opened during normal daily activities of calm breathing, but only briefly and immediately during the breath-holding action. It occurs more frequently in patients with pulmonary hypertension and heart failure because of increased intracardiac pressure. About 46.8% of patients with WHO class III cardiac function have PFO, and 61.2% of patients with the first major category of pulmonary arterial hypertension have PFO. This means that most of the pulmonary hypertension, especially when the heart function is damaged, the body will reopen the natural channel of PFO, thereby reducing heart failure and cardiac chamber pressure. But firstly, for most people, the fissure is too small to balance and relieve the pressure of the heart chamber; secondly, for most people, it only opens when the pressure increases temporarily, and in most cases The lower is the closed state, which cannot balance and relieve the pressure of the cardiac chambers; thirdly, due to its valve-like natural anatomical structure, it is only possible to open when the pressure of the right atrium exceeds that of the left atrium, that is, when the heart is severely damaged. Prolonged. Therefore, the protective potential of this natural channel against pulmonary hypertension is very limited.

Against this background, in the past decade or so, different research centers have tried to find a new way, artificially perforating a fistula through catheter intervention at the atrial septum at the junction of the left and right atria, or even undergoing a surgical ostomy, and the clinical symptoms of patients have been compared. Good improvement. However, due to the complicated operation, the high cost of drilling technology and equipment, many complications, relatively high surgical safety, and easy closure of the fistula hole, etc., the international application is very limited. Relief of symptoms and heart failure for a period of time, and even only recommended for palliative care during the waiting period before lung transplantation.

The invention aims at the above defects of atrial septostomy, and at the same time utilizes the backup system of human body's natural compensatory protection. In patients with pulmonary hypertension, the anatomical structure of the naturally open foramen ovale does not require atrial septal puncture. Or punching holes, avoiding the corresponding high costs and corresponding complications, and achieving the purpose of balancing the pressure of the left and right atrial and quickly relieving the patient's heart load. Thereby reducing the pulmonary artery pressure in patients with pulmonary arterial hypertension, reducing the progression of the disease, protecting the structure and function of the right heart of pulmonary arterial hypertension, improving the quality of life of patients, and reducing the rehospitalization rate and mortality of patients. It also reduces the total cost of treatment for the patient.

SUMMARY OF THE INVENTION

In view of the above problems, the present invention proposes a novel foramen ovale opening device for pulmonary hypertension.

The technical scheme adopted in the present invention is:

A novel foramen ovale opening device for pulmonary hypertension, the opening device comprising a placer with a central open hole therethrough, the distal end and the proximal end of the placer are each provided with a first traction ring and a second traction ring , the first traction ring and the second traction ring are respectively connected by the first support rod and the second support rod, the end walls of the first traction ring and the second traction ring are provided with connecting pieces, the The two ends are respectively provided with locking parts matched with the connecting piece. When the first traction ring and the second traction ring are gathered toward the placer, the first support rod and the second support rod are bent to form a right disk and a left disk, and The connecting piece is connected with the locking part.

Preferably, a first sealing ring and a second sealing ring are provided on the end surfaces of the first traction ring and the second traction ring facing the placer, and the connecting member is provided on the end surfaces of the first sealing ring and the second sealing ring.

Preferably, the connecting piece includes a clamping block, one end of the clamping block is fixed on the end ring surface of the first sealing ring or the second sealing ring, and the outer wall of the clamping block is provided with a lengthwise placement groove, so The inner side of the placing groove is provided with an accommodating groove communicating with it, a compression spring and an elastic metal sheet are arranged in the accommodating groove, and the compression spring is located between one end of the elastic metal sheet and the inner end wall of the accommodating groove, and the elastic metal The other end of the sheet is fixed in the placement slot.

Preferably, the locking portion includes a locking groove, the locking groove is provided on the distal and proximal annular surfaces of the placer, and an arc-shaped locking groove matching the elastic metal sheet is provided on the upper wall of the locking portion .

Preferably, the inner wall of the first sealing ring is provided with a first inner thread that can be screwed with the end of the first push rod, and the inner wall of the second sealing ring is provided with a second inner thread that is screwed with the end of the second push rod thread.

Beneficial effects of the present invention:

The present invention aims at the special treatment needs of patients with pulmonary arterial hypertension, and expects to reopen the foramen ovale. Therefore, on the basis of the existing mature technology of placing an occluder through PFO, it overcomes the completely closed design of the existing PFO occluder, which is not suitable for requirements for the opening of pulmonary arterial hypertension; at the same time, the existing balloon atrial septostomy is used to open both sides of the left and right atrium to achieve the purpose of decompression, but it overcomes the latter's many side effects, additional trauma, high cost, and self-regrowth Disadvantages such as closing and failing. Therefore, it is safe, simple, cost-effective and long-term to keep the left and right atrial channels open, treat pulmonary hypertension, and protect cardiac function.

Description of drawings

In order to explain the embodiments of the present invention or the technical solutions in the prior art more clearly, the following briefly introduces the accompanying drawings that need to be used in the description of the embodiments or the prior art. Obviously, the accompanying drawings in the following description are only These are some embodiments of the present invention. For those of ordinary skill in the art, other drawings can also be obtained according to these drawings without creative efforts.

Figure 1 is a schematic diagram of the operation process of the existing PFO occlusion surgery ((A. The PFO occluder is sent from the PFO to the left atrium through the right atrium; B. The left parachute disc of the PFO occluder is opened respectively, and the PFO occluder is gently pulled back. After the occluder, open the right umbrella plate of the PFO occluder; C. The end of the delivery rod is separated from the PFO occluder, and the PFO occluder is released.

Figure 2 is a schematic diagram of the operation of balloon dilation of atrial septostomy.

Figure 3 is an illustration of an existing PFO occluder (inverse bracket shape, no holes).

Figure 4 shows the placement of the PFO occluder (inverse bracket shape, no holes, and takes up a lot of space)

5 is a cross-sectional view of a novel foramen ovale opening device for pulmonary hypertension according to the present invention when it is contracted;

6 is a cross-sectional view of a novel foramen ovale opening device for pulmonary hypertension according to the present invention after it is completely anchored;

Fig. 7 is the enlarged view of A place in Fig. 5;

FIG. 8 is an enlarged view of B in FIG. 5 .

2. The first traction ring; 3. The second traction ring; 4. The first sealing ring; 5. The second sealing ring; 6. The second support rod; 7. The first support rod; 8 801, block; 802, placement slot; 803, accommodating slot; 804, compression spring; 805, elastic metal sheet; 9, locking part; 901, card slot; 902, arc locking slot; 10 , the end of the first push rod; 11, the end of the second push rod.

Detailed ways

In order to make the purpose, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be described clearly and completely below with reference to the accompanying drawings in the embodiments of the present invention.

(1) PFO occlusion

Indications: For the PFO population at high risk of right heart system thrombosis, if the pore of the patent foramen ovale is larger than 5 mm, the transient increase in pulmonary pressure may lead to the right heart system when the patient coughs or sneezes The blood flows to the left ventricular system through the end of the foramen ovale, and some small emboli that cause the systemic circulation will reach the left ventricular system, causing repeated cerebral embolism and migraine symptoms. In this case, interventional sealing is required. Occlusion therapy.

Operation process: As shown in Figure 1, the femoral vein at the root of the thigh is punctured, and a thin catheter is placed; the thin catheter can reach the right atrium along the blood vessel, and then pass through the patent foramen ovale to the left atrium; A special occluder is drawn in a straight line and sent along a thin catheter to the left atrium; the occluder is finally released to close the patent foramen ovale. The operation takes about 30 minutes.

(2) Atrial septostomy

Indications: Severe pulmonary arterial hypertension, which needs to improve symptoms or relieve heart failure in a short period of time; or palliative treatment for patients with pulmonary arterial hypertension before lung transplantation, in order to improve symptoms in a short time, strive for transplantation opportunities, improve the success rate of transplantation operations, and reduce surgery and anesthesia risk.

Operation process: As shown in Figure 2, the catheter is inserted through the femoral vein and reaches the right atrium through the inferior vena cava. At the weakest point above the fossa ovalis or the interatrial septum, the atrial septal needle is punctured and punched, and the guide wire is guided to the left atrium. atrium. Then, the balloon is sent through the catheter along the guide wire, and balloon dilation is performed on the punched hole. It is expected that the diameter is sufficient to buffer the pressure of the left and right hearts on both sides, and it is also expected that the hole can be kept open for a long time. The procedure takes about 1-2 hours.

As mentioned above, for PFO patients without pulmonary hypertension, but a high-risk group of right heart system thrombosis, after strict clinical evaluation, some patients underwent PFO occlusion to prevent thrombus from passing through PFO and causing left heart system blood vessel embolism. Therefore, through the natural fissure of the PFO, a PFO occluder with a closure device was prophylactically placed under the guidance of a guide wire. Because PFO is very common and has a large population base, technology and equipment have developed rapidly in recent years, and this aspect is basically mature. However, for patients with pulmonary hypertension, we hope to reopen the foramen ovale, or even keep the foramen open for a long time, so as to reduce the damage of pulmonary blood vessels and other organs caused by pulmonary artery pressure and right atrial pressure for a long time. As mentioned above, although transcatheter atrial septal puncture balloon dilation has appeared in recent years, the clinical symptoms of patients with pulmonary arterial hypertension have been improved, but this technique is complicated by the operation, the drilling technology and equipment increase the expensive cost, bleeding, There are many serious complications such as tearing, arrhythmia, pericardial effusion, etc., and the safety of the operation is relatively poor, which may lead to bleeding, atrial septal tear, and induce arrhythmia. Closure, low long-term patency rate, etc., the international application is very limited, but for patients with severe pulmonary hypertension, in order to relieve symptoms and heart failure in a short period of time, it is even recommended for palliative treatment in the waiting period before lung transplantation. .

Therefore, the present invention proposes a novel foramen ovale opening device for pulmonary hypertension, which not only utilizes the mature PFO occlusion operation technology and the good fixation principle of the occluder, but also combines the atrial septostomy to treat pulmonary hypertension. The original intention and effect are that the foramen ovale, a naturally occurring pore anatomy, is used to avoid various shortcomings of atrial septostomy balloon dilation.

As shown in FIG. 5 , the opening device includes an applicator 1 having a central open hole through it. The distal end and the proximal end of the applicator 1 are respectively provided with a first traction ring 2 and a second traction ring 3 . A traction ring 2 and a second traction ring 3 are respectively connected by a first support rod 7 and a second support rod 6 , and a connecting piece 8 is provided on the end walls of the first traction ring 2 and the second traction ring 3 . The two ends of the placer 1 are respectively provided with locking parts 9 which are matched with the connecting piece 8. When the first traction ring 2 and the second traction ring 3 are gathered towards the placer 1, the first support rod 7 and the second support The rod 6 is bent to form the right disk and the left disk, and the connecting piece 8 is connected with the locking part 9 . According to the pressure difference between the left and right atrium, the shunt flow and the aperture value are calculated, so as to design different types of opening devices with holes.

In this embodiment, as shown in FIGS. 5 , 7 and 8 , the end surfaces of the first traction ring 2 and the second traction ring 3 facing the placer are provided with a first sealing ring 4 and a second sealing ring 6 . The connecting pieces 8 are arranged on the end faces of the first sealing ring 4 and the second sealing ring 5 . The connector 8 includes a blocking block 801, one end of the blocking block 801 is fixed on the end ring surface of the first sealing ring 4 or the second sealing ring 5, and the outer wall of the blocking block 801 is provided with a lengthwise placement Slot 802, the inner side of the placement slot 802 is provided with an accommodating slot 803 communicating with it, and a compression spring 804 and an elastic metal sheet 805 are arranged in the accommodating slot 803, and the compression spring 804 is located at one end of the elastic metal sheet 805 and accommodates Between the inner end walls of the slot 803 , the other end of the elastic metal sheet 805 is fixed in the placement slot 802 . The locking portion 9 includes a card slot 901 , the card slot 901 is arranged on the distal end and the proximal end ring surface of the placer 1 , and the upper wall of the card slot 901 is provided with an arc that matches the elastic metal sheet 805 . Lock slot 902 .

Wherein, the inner wall of the first sealing ring 4 is provided with a first inner thread that can be screwed with the end 10 of the first push rod, and the inner wall of the second sealing ring 5 is provided with a thread that is screwed with the end 11 of the second push rod Second internal thread.

Figure 3 shows the existing PFO occluder, and its left and right disk surfaces are in the shape of a reverse bracket and have no holes; Figure 4 shows the placement of the existing PFO occluder, because the reverse bracket shape and no holes take up a lot of space.

In this embodiment, the applicator 1 , the first traction ring 2 , the second traction ring 3 , the first sealing ring 4 , the second sealing ring 5 , the first support rod 7 and the second support rod 6 are all medically degradable The material is made by laser cutting, and the first support rod 7 and the second support rod 6 can be fixed on the first traction ring 2, the second traction ring 3 and the outer wall of the placer 1 by means of laser welding or adhesive bonding . And can do drug coating treatment to prevent thrombosis. The clamping block 801 can also be made of medical degradable material by laser cutting, and can form an integral structure with the first sealing ring 2 and the second sealing ring 3. The compression spring 804 and the elastic metal sheet 805 are made of medical material, and also Do drug coating treatment.

The specific operation of the opening device of the present invention is as follows:

First, after local anesthesia, a catheter is inserted into a large vein (femoral vein) through a small incision in the groin of the thigh, and the catheter is slowly delivered to the heart. The opening device is then delivered through the catheter to the location of the heart's foramen ovale. Once the correct position is confirmed, the opening device needs to be stretched, the first support rod 7 and the second support rod 6 need to be retracted, the first sealing ring 2 is pulled back by the end 10 of the first push rod, and the first support rod 7 begins to bend, forming a left Then, the push rod 11 pushes the second seal ring 3, the second support rod 6 starts to bend, and forms a right disk, at this time, the first seal ring 2 and the second seal ring 3 are clamped on both ends of the placer 1 In the slot on the side wall, the elastic metal sheet 805 is clipped into the arc-shaped locking slot 902 to realize the fixed connection between the first traction ring 2 and the second traction ring 3 and the placer 1, so that the left disk and the right disk are Stabilization is expanded on both sides of the atrial septum (as shown in Figure 6) to prevent abnormal blood flow in the atrium of the heart. Finally, the catheter connecting the second push rod end 11 and the first push rod end 10 is withdrawn from the body, and the interventional occlusion is completed. The entire open device implantation takes about 30 minutes.

The present invention is aimed at patients with moderate and severe pulmonary arterial hypertension. The increased pulmonary arterial pressure leads to obvious right heart enlargement and pressure increase, and even patients with right heart failure can reopen through the foramen ovale to relieve the pressure of the right heart system, improve the function of the right heart, and treat the pulmonary artery. Increased pressure leads to right heart damage. Therefore, the device of the present invention is combined with the two technologies of sealing the foramen ovale and atrial septum perforation and balloon dilation. In order to use the natural anatomical structure of the foramen ovale, learn from the mature and widely used foramen ovale closure operation technology and the fixation principle of the foramen ovale occluder, and at the same time avoid the invasive and high cost of atrial septal perforation and balloon dilation. Complications and the shortcomings of easy closure, through the existing transfemoral catheter intervention methods, through the femoral vein, inferior vena cava, right atrium, foramen ovale or small atrial septal defect to the left atrium, minimally invasive implantation of the open The device can maintain the small traffic between the left and right rooms for a long time, relieve the excessive right atrial pressure caused by pulmonary hypertension, buffer the right heart pressure, and protect and treat the right heart function.

The total number of equipment of the present invention is only used to illustrate the technical solution of the present invention, and does not limit other modifications or equivalent replacements made by those of ordinary skill in the art to the technical solution of the present invention, as long as it does not depart from the spirit and scope of the technical solution of the present invention, All should be included in the scope of the claims of the present invention.

Claims (5)

1. a novel foramen ovale opening device for pulmonary arterial hypertension, is characterized in that, this opening device comprises the placer that has the central opening hole that passes through, and the distal end and proximal end of described placer are each provided with the first traction A ring and a second traction ring, the first and second traction rings are respectively connected by a first support rod and a second support rod, and the end walls of the first and second traction rings are provided with connecting pieces , the two ends of the placer are respectively provided with locking parts matched with the connecting piece. When the first traction ring and the second traction ring are gathered towards the placer, the first support rod and the second support rod are bent to form a right disc and the left disc, and the connecting piece is connected with the locking part. 2. A novel foramen ovale opening device for pulmonary hypertension according to claim 1, wherein the end faces of the first and second traction rings facing the placer are provided with a first sealing ring and a The second sealing ring, the connecting piece is arranged on the end faces of the first sealing ring and the second sealing ring. 3. A novel foramen ovale opening device for pulmonary hypertension according to claim 2, wherein the connecting piece comprises a block, and one end of the block is fixed on the first sealing ring or the second On the end ring surface of the sealing ring, the outer wall of the clamping block is provided with a lengthwise placement groove, the inner side of the placement groove is provided with a accommodating groove that communicates with it, and a compression spring and an elastic metal sheet are arranged in the accommodating groove. , the compression spring is located between one end of the elastic metal sheet and the inner end wall of the accommodating groove, and the other end of the elastic metal sheet is fixed in the accommodating groove. 4. A novel foramen ovale opening device for pulmonary hypertension according to claim 3, characterized in that the locking portion comprises a catch groove, and the catch groove is provided at the distal end and the proximal end of the placer On the annular surface, an arc-shaped locking groove matched with the elastic metal sheet is arranged on the upper wall of the clamping groove. 5. a kind of novel foramen ovale opening device for pulmonary hypertension according to claim 1, is characterized in that, the inner wall of described first sealing ring is provided with the first inner wall which can be screwed with the end of the first push rod. The inner wall of the second sealing ring is provided with a second inner thread which can be connected with the end of the second push rod.

Images