CN114869425A - Novel oval hole opening device for pulmonary artery high pressure - Google Patents

Abstract

The invention provides a novel oval hole opening device for pulmonary hypertension, aiming at the special treatment requirements of patients with pulmonary hypertension, the oval hole is expected to be opened again, so that the technical basis that the existing PFO plugging device is placed through the PFO in the mature process is overcome, the completely closed design of the existing PFO plugging device is overcome, and the device is not suitable for the opening requirement of pulmonary hypertension; meanwhile, the two side passages of the left atrium and the right atrium are opened by combining and utilizing the existing balloon interatrial septum ostomy, so that the purpose of decompression is achieved, and the defects of more side effects, additional trauma, high cost, failure of self-regrowth closure and the like of the left atrium and the right atrium are overcome. Thereby safely, simply, economically and effectively keeping the left atrium channel and the right atrium channel open for a long time, treating pulmonary hypertension and protecting the heart function.

Description

Novel oval hole opening device for pulmonary artery hypertension

Technical Field

The invention belongs to the technical field of medical instruments, and particularly relates to a novel oval hole opening device for pulmonary hypertension.

Background

Pulmonary Hypertension (PH) is a malignant Pulmonary vascular disease group with right heart failure caused by a progressive increase in right heart load with increased Pulmonary artery pressure, increased Pulmonary vascular Pulmonary resistance, and the like. According to the registration data of the national institute of health, the mortality rate in 1 year after the diagnosis of PH is 32%, the mortality rates in 2 and 5 years are respectively increased to 52% and 66%, and nearly half of PH patients die within 2-3 years after the diagnosis; even with successful lung or combined heart and lung transplants, the 3-and 5-year survival rates are only 55% and 45%, and even with current drug combination regimens, about more than half of patients die within 7 years, manifesting as "cancer" in cardiovascular disease. The research on new therapeutic drugs, instruments and methods thereof is always the focus and focus of research in the field of cardiovascular and pulmonary vessels.

The foramen ovale is a physiological channel of the embryo stage of the atrial septum of the heart, and after about 5-7 months of birth, secondary septa and primary septa of most human atrial septa are mutually adhered and fused to form permanent atrial septa, and if not fused, Patent Foramen Ovale (PFO) is formed. Approximately 25% to 34% of normal adults have incompletely fused the two layers of the fossa ovalis, leaving a permanent fissure-like defect. This slit is door-axis or flap-like and can only open when the pressure on the right is greater than on the left. So the PFO does not open during normal daily activities of calm breathing, but only opens momentarily during the breath holding action. In patients with pulmonary hypertension and heart failure, the incidence is higher because of increased intracardiac pressure. PFO is present in about 46.8% of patients with WHO third-order cardiac function, and PFO is present in 61.2% of patients with pulmonary hypertension of the first major category. This means that most pulmonary hypertension, especially when cardiac function is compromised, the body reopens the natural PFO channel, relieving heart failure and heart chamber pressure. But the first aspect is that the fissures are too small for most people to balance and relieve the pressure in the heart chamber; in the second aspect, for most people, the heart valve is opened only when the pressure is excessively increased, but is closed in most cases, and cannot balance and relieve the pressure of the heart cavity; the third aspect, due to its valve-like natural anatomy, opens only when the right atrium pressure exceeds the left atrium, i.e. when severe cardiac damage is reached, a prolonged opening time is possible. Thus, this natural channel has very limited protective potential against pulmonary hypertension.

Under the background, in more than ten years, different research centers try to develop a new method, and the clinical symptoms of patients are better improved by artificially perforating and fistulizing at the interatrial space where the left atrium and the right atrium are connected through a catheter intervention operation, even by performing an ostomy operation under a surgical operation. But the international range of applications is very limited due to the complicated operation, the expensive cost of the punching equipment, the more complications, the relatively high safety of the operation, the easy closing of the stoma and so on, and the clinical application is only recommended for patients with severe pulmonary hypertension to relieve symptoms and heart failure in a short period of time, even for palliative treatment during the waiting period before the lung transplantation operation.

Aiming at the defects of interatrial fistula and simultaneously utilizing a standby system for natural compensatory protection of a human body, the invention does not need puncturing or punching the interatrial septum in a patient with pulmonary hypertension through an anatomical structure of a natural open foramen ovale, avoids corresponding high cost and corresponding complications, and achieves the purposes of balancing the pressure of the left atrium and the right atrium and quickly relieving the heart load of the patient. Thereby reducing the pulmonary artery pressure of the patient with pulmonary hypertension, relieving the progress of diseases, protecting the right heart structure and function of the pulmonary hypertension, improving the life quality of the patient and reducing the death rate of the patient after hospitalization. And also reduces the overall treatment cost of the patient.

Disclosure of Invention

In order to solve the problems, the invention provides a novel oval foramen opening device for pulmonary hypertension.

The technical scheme adopted by the invention is as follows:

the utility model provides a be used for highly compressed novel oval hole of pulmonary artery to open device, this open device is including having the placer that the hole was opened in the center that link up, the distal end and the near-end of placer respectively are provided with first pull ring and second pull ring, first pull ring and second pull ring are connected through first bracing piece and second bracing piece respectively, be provided with the connecting piece on the end wall of first pull ring and second pull ring, the both ends of placer then are provided with respectively with connecting piece matched with locking portion, when first pull ring and second pull ring gather together to the placer, the crooked right side dish and the left side dish that forms of first bracing piece and second bracing piece, and the connecting piece realizes being connected with locking portion.

Preferably, the end faces of the first traction ring and the second traction ring facing the placer are provided with a first sealing ring and a second sealing ring, and the connecting piece is arranged on the end faces of the first sealing ring and the second sealing ring.

Preferably, the connecting piece comprises 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, a placing groove in the length direction is formed in the outer wall of the clamping block, a containing groove communicated with the placing groove is formed in the inner side of the placing groove, a compression spring and an elastic metal sheet are arranged in the containing groove, the compression spring is located between one end of the elastic metal sheet and the inner end wall of the containing groove, and the other end of the elastic metal sheet is fixed in the placing groove.

Preferably, the locking part comprises a clamping groove, the clamping groove is arranged on the ring surface of the far end and the near end of the placer, and an arc-shaped locking groove matched with the elastic metal sheet is arranged on the upper wall of the clamping groove.

Preferably, a first internal thread capable of being in threaded connection with the tail end of the first pushing rod is arranged on the inner wall of the first sealing ring, and a second internal thread in threaded connection with the tail end of the second pushing rod is arranged on the inner wall of the second sealing ring.

The invention has the beneficial effects that:

aiming at the special treatment requirements of the pulmonary hypertension patient, the invention expects to reopen the foramen ovale, thus overcoming the defect that the existing PFO occluder is completely closed and is not suitable for the patency requirement of the pulmonary hypertension on the basis of the existing technology for placing the occluder through the PFO; meanwhile, the two-side access of the left atrium and the right atrium is opened by combining and utilizing the existing balloon interatrial septum ostomy, the purpose of pressure reduction is achieved, and the defects that the latter has more side effects, additional trauma, high cost, failure due to self-regrowth and closure and the like are overcome. Thereby safely, simply, economically and effectively keeping the left atrium channel and the right atrium channel open for a long time, treating pulmonary hypertension and protecting the heart function.

Drawings

In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below, it is obvious that the drawings in the following description are only some embodiments of the present invention, and for those skilled in the art, other drawings can be obtained according to the drawings without creative efforts.

Fig. 1 is a schematic diagram of the operation process of the existing PFO plugging operation (A. the PFO plugging device is sent from the PFO to the left atrium through the right atrium, B. the umbrella disc on the left side of the PFO plugging device is opened respectively, after the PFO plugging device is pulled back slightly, the umbrella disc on the right side of the PFO plugging device is opened, C. the tail end of a conveying rod is separated from the PFO plugging device, and the PFO plugging device is released.

Fig. 2 is a schematic view of a septal ostomy balloon dilatation procedure.

Figure 3 shows the prior art PFO occluder intent (in parenthesis, no holes).

Figure 4 shows PFO occluder placement (reversed bracket shape, no hole, more space occupation)

FIG. 5 is a cross-sectional view of the novel foramen ovale opening device for pulmonary hypertension according to the present invention, as contracted;

FIG. 6 is a cross-sectional view of the novel foramen ovale opening device for pulmonary hypertension of the present invention fully anchored;

FIG. 7 is an enlarged view taken at A in FIG. 5;

fig. 8 is an enlarged view at B in fig. 5.

Wherein, 1, a placer; 2. a first traction ring; 3. a second traction ring; 4. a first seal ring; 5. a second seal ring; 6. a second support bar; 7. a first support bar; 8. a connecting member; 801. a clamping block; 802. a placement groove; 803. accommodating grooves; 804. a compression spring; 805. a resilient metal sheet; 9. a locking portion; 901. a card slot; 902. an arc-shaped locking groove; 10. a first push rod end; 11. the second push rod is arranged at the tail end.

Detailed Description

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

(1) PFO occlusion

Indications are as follows: for the high risk PFO population with right heart system thrombus, if the patent foramen ovale has larger pore space which is larger than 5 mm, when the patient coughs or sneezes, transient pulmonary pressure increase can cause blood in the right heart system to flow to the left heart system through the patent foramen ovale end closure, and some small emboli in the systemic circulation can reach the left heart system to cause repeated cerebral embolism, and the symptoms of migraine can occur, and under the condition, the intervention plugging device needs to be used for treatment.

The operation process is as follows: as shown in fig. 1, the femoral vein at the base of the thigh is punctured and a thin catheter is placed; a thin catheter may be passed down the blood vessel to the right atrium, then through the patent foramen ovale to the left atrium; at the moment, the special occluder can be drawn into a straight line and sent to the left atrium along the thin catheter; and finally releasing the plugging device to close the patent foramen ovale. The operation process took approximately 30 minutes.

(2) Interatrial septum fistulation

Indications are as follows: severe pulmonary hypertension, a short period of time in which improvement of symptoms is desired, or alleviation of heart failure; or the treatment means is palliative before lung transplantation of the patient with pulmonary hypertension, so as to improve symptoms in a short time, strive for transplantation opportunities, improve the success rate of transplantation operations and reduce the risks of operations and anesthesia.

The operation process is as follows: as shown in figure 2, the catheter is inserted through the femoral vein and into the right atrium via the inferior vena cava, and the septum puncture needle punctures a hole in the fossa ovalis or the weakest point above the interatrial septum, and the guidewire is guided down to the left atrium. And then the balloon is sent into the balloon through a catheter along the guide wire, and the balloon expansion is carried out on the punched hole, wherein the balloon is expected to have enough diameter to buffer the pressure of the left and right heart at two sides and also be expected to be capable of keeping the left and right heart open for a long time. The surgical procedure is about 1-2 hours.

As described above, in the case of PFO patients without pulmonary hypertension but at high risk of right heart system thrombosis, according to the strict clinical evaluation, PFO occlusion was performed in some patients to prevent thrombosis through PFO to cause left heart system vascular embolism. Thus preventively placing a PFO stopper of a closure device under guide wire guidance through the natural fissures of the PFO. Since PFO is very common and large population base, technology and equipment have advanced rapidly in recent years, with this aspect becoming largely mature. But for pulmonary hypertension patients we want to reopen the foramen ovale, even keeping the foramen ovale open for a long period of time, thus permanently relieving the pulmonary artery pressure and the damage to the pulmonary vessels and other organs caused by the pressure in the right atrium. As described above, although the clinical symptoms of the pulmonary hypertension patient are improved well in recent years by the transcatheter interatrial puncture balloon dilatation, the technique has relatively poor operation safety, severe complications such as bleeding, laceration of interatrial septum, arrhythmia induction of arrhythmia and the like, and failure due to intolerable pain of the patient, easy closure of fistulation hole, low long-term patency rate and the like because of complicated operation, high cost of perforation technique equipment, severe complications such as bleeding, laceration, arrhythmia, pericardial effusion and the like, and is very limited in international application.

Therefore, the invention provides a novel foramen ovale opening device for pulmonary hypertension, which not only utilizes mature PFO (Perfluorooctane phosphate) plugging operation technology and a good fixing principle of a plugging device, but also combines the original intention and effect of treating the pulmonary hypertension by interatrial fistula, utilizes a naturally existing pore anatomy such as the foramen ovale, and well avoids various defects of the interatrial fistula sacculus dilatation.

As shown in fig. 5, the opening device comprises a placing device 1 with a through central opening hole, a first traction ring 2 and a second traction ring 3 are respectively arranged at the far end and the near end of the placing device 1, the first traction ring 2 and the second traction ring 3 are respectively connected through a first support rod 7 and a second support rod 6, a connecting piece 8 is arranged on the end wall of the first traction ring 2 and the end wall of the second traction ring 3, locking parts 9 matched with the connecting piece 8 are respectively arranged at the two ends of the placing device 1, when the first traction ring 2 and the second traction ring 3 are gathered towards the placing device 1, the first support rod 7 and the second support rod 6 are bent to form a right disc and a left disc, and the connecting piece 8 is connected with the locking parts 9. And the numerical values of the flow distribution and the aperture are calculated according to the pressure difference of the left atrium and the right atrium, so that the open devices with holes of different models are designed.

In this embodiment, as shown in fig. 5, 7 and 8, the first traction ring 2 and the second traction ring 3 are provided with a first sealing ring 4 and a second sealing ring 6 facing the end surface of the placer, and the connecting member 8 is provided on the end surfaces of the first sealing ring 4 and the second sealing ring 5. The connecting piece 8 comprises a fixture block 801, one end of the fixture block 801 is fixed on an end ring surface of the first sealing ring 4 or the second sealing ring 5, a placement groove 802 in the length direction is formed in the outer wall of the fixture block 801, an accommodating groove 803 communicated with the placement groove 802 is formed in the inner side of the placement groove 802, a compression spring 804 and an elastic metal sheet 805 are arranged in the accommodating groove 803, the compression spring 804 is located between one end of the elastic metal sheet 805 and the inner end wall of the accommodating groove 803, and the other end of the elastic metal sheet 805 is fixed in the placement groove 802. The locking part 9 comprises a clamping groove 901, the clamping groove 901 is arranged on the ring surface of the far end and the near end of the placer 1, and the upper wall of the clamping groove 901 is provided with an arc-shaped locking groove 902 matched with the elastic metal sheet 805.

The inner wall of the first sealing ring 4 is provided with a first internal thread which is spirally connected with the tail end 10 of the first push rod, and the inner wall of the second sealing ring 5 is provided with a second internal thread which is spirally connected with the tail end 11 of the second push rod.

FIG. 3 is a prior PFO occluder, the left disc surface and the right disc surface of which are in a reversed bracket shape and have no holes; figure 4 shows the placement of a prior PFO stopper, which is in a reversed bracket shape, has no hole and occupies more space.

The placer 1, the first traction ring 2, the second traction ring 3, the first sealing ring 4, the second sealing ring 5, the first supporting rod 7, the second supporting rod 6 and the like in the embodiment are all made of medical degradable materials through laser cutting, and the first supporting rod 7 and the second supporting rod 6 can be fixed on the outer walls of the first traction ring 2, the second traction ring 3 and the placer 1 in a laser welding or adhesive bonding mode. And can be used for treating drug coating to prevent thrombosis. The fixture block 801 can also be made of medical degradable materials through laser cutting, the fixture block can form an integrated structure with the first sealing ring 2 and the second sealing ring 3, and the compression spring 804 and the elastic metal sheet 805 are made of medical materials and are also processed through medicine coating.

The opening device of the present invention specifically operates as follows:

after first local anaesthesia, the catheter is inserted into a large vein (femoral vein) through a small incision in the groin of the thigh, and slowly delivered to the heart. The opening device is then delivered through a catheter to the site of the foramen ovale of the heart. Once the correct position is confirmed, the opening device needs to be opened, the first support rod 7 and the second support rod 6 need to be contracted, the first sealing ring 2 is pulled back through the tail end 10 of the first push rod, the first support rod 7 starts to bend to form a left disc, then the second sealing ring 3 is pushed by the push rod 11, the second support rod 6 starts to bend to form a right disc, at the moment, the clamping blocks on the first sealing ring 2 and the second sealing ring 3 are clamped into the clamping grooves on the side walls of the two ends of the placer 1, and meanwhile, the elastic metal sheet 805 is clamped into the arc-shaped locking groove 902, so that the fixed connection between the first traction ring 2 and the second traction ring 3 and the placer 1 is realized, and the left disc and the right disc are stably expanded and formed on the two sides of the atrial septum (as shown in fig. 6) to prevent abnormal blood flow in the heart room. Finally, the catheter is communicated with the tail end 11 of the second pushing rod and the tail end 10 of the first pushing rod to be withdrawn from the body, and the interventional occlusion operation is completed. The entire open device implantation takes about 30 minutes.

Aiming at patients with moderate and severe pulmonary hypertension, the pressure of the pulmonary artery is increased to obviously increase the right heart and increase the pressure, even the patients with right heart failure are reopened through the oval hole, so that the pressure of the right heart system is relieved, the right heart function is improved, and the right heart damage caused by the increase of the pulmonary artery pressure is treated. Therefore, the device is combined with two technologies of foramen ovale plugging and interatrial septum perforation saccule dilation. The natural pore anatomical structure of the oval hole is used for reference, the mature and widely applied oval hole plugging operation technology and oval hole plugging device fixing principle are used, the defects of wound, high complication and easiness in closing of atrial septal perforation balloon dilatation are avoided, the existing transfemoral catheter intervention method is used for achieving the path of the left atrium through femoral vein, inferior vena cava, right atrium, oval hole or atrial septal defect, the open device is implanted in a minimally invasive mode, small traffic of the left room and the right room is kept for a long time, the excessive right atrium pressure caused by pulmonary hypertension is relieved, the right atrium pressure is buffered, and the right atrium function is protected and treated.

The device of the present invention is only used for illustrating the technical solution of the present invention, and is not limited to other modifications or equivalent replacements made by the technical solution of the present invention by those of ordinary skill in the art, so long as the spirit and scope of the technical solution of the present invention are not deviated from the scope of the claims of the present invention.

Claims (5)

1. The utility model provides a be used for highly compressed novel oval hole of pulmonary artery to open device, its characterized in that, this open device is including having the placer that the hole was opened in the center that link up, the distal end and the near-end of placer respectively are provided with first pull ring and second pull ring, first pull ring and second pull ring are connected through first bracing piece and second bracing piece respectively, be provided with the connecting piece on the end wall of first pull ring and second pull ring, the both ends of placer then are provided with respectively with connecting piece matched with locking portion, when first pull ring and second pull ring to the placer gather together, the crooked right side dish and the left dish that forms of first bracing piece and second bracing piece, and the connecting piece realizes being connected with locking portion.

2. The novel foramen ovale opening device for pulmonary hypertension according to claim 1, wherein the end faces of the first traction ring and the second traction ring facing the placer are provided with a first sealing ring and a second sealing ring, and the connecting member is arranged on the end faces of the first sealing ring and the second sealing ring.

3. The novel foramen ovale opening device for pulmonary artery hypertension according to claim 2, wherein the connecting piece comprises a clamping block, one end of the clamping block is fixed on an end ring surface of the first sealing ring or the second sealing ring, a placement groove in the length direction is arranged on the outer wall of the clamping block, a containing groove communicated with the inner side of the placement groove is arranged on the inner side of the placement groove, a compression spring and an elastic metal sheet are arranged in the containing groove, the compression spring is located between one end of the elastic metal sheet and an end wall in the containing groove, and the other end of the elastic metal sheet is fixed in the containing groove.

4. The patent refers to the field of 'surgical instruments, devices or methods'.

5. The novel foramen ovale opening device for pulmonary artery hypertension as claimed in claim 1, wherein the inner wall of the first sealing ring is provided with a first internal thread which can be connected with the end of the first pushing rod in a screw manner, and the inner wall of the second sealing ring is provided with a second internal thread which can be connected with the end of the second pushing rod in a screw manner.

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