Cardiac surgery minimally invasive coronary artery-pulmonary artery fistula clipping device and use method

Abstract

The invention discloses a cardiac surgery minimally invasive coronary artery-pulmonary artery fistula clipping device and a using method, and the cardiac surgery minimally invasive coronary artery-pulmonary artery fistula clipping device comprises an inner sealing disc which is of a disc structure, the bottom surface of the inner sealing disc is one-eighth radian, and the inner sealing disc is configured to be clamped into a pulmonary artery valve ring; the bottom of the fixed disc is connected with fine wires; the outer layer of the memory alloy stent has temperature response plasticity and is completely attached to the inner wall of the pulmonary artery in a bending state; the side face of the outer closed disc is of a disc-shaped structure with the one-eighth radian, layered corrugated belts are arranged at the bottom, and grooves are formed in the top. The regulation and control lock comprises a base disc and a spinning disc; the base disc is a hard wafer with an external threaded column and is embedded into the groove in a matched manner; the spinning disc is a hard disc with a prismatic hollow pipe and is connected to the external threaded column in a screwed mode. And the guide sheath pipeline is internally provided with the inner sealing disc which is compressed into a columnar shape and is integrated with a lifting guide wire. According to the invention, various complications such as myocardial infarction, occluder embolism and the like caused by the prior art can be reduced, and the problems of postoperative coronary artery expansion and residual orificium fistulae are avoided.

Description

Technical Field

[0001] This invention belongs to the field of cardiac surgical medical device technology, and relates to a minimally invasive coronary artery-pulmonary artery fistula clamping device and its usage method. Background Technology

[0002] Coronary artery fistula ( Regulating lock inner seal disc Fs Coronary artery fistulas (CAFs) are a rare type of coronary artery malformation, often discovered during coronary angiography. Small CAFs generally do not cause clinical symptoms and may even close spontaneously. Medium or large CAFs can lead to coronary artery dilation and ischemia, resulting in a range of clinical symptoms.

[0003] With advancements in surgical and interventional techniques and the development of medical diagnostic technologies, more and more coronary artery fistulas can be detected and treated at an early stage. However, suturing or sealing the fistula opening is not a "minor surgery." When performed near the coronary arteries, common complications include myocardial infarction, occluder embolization, and fistula recanalization.

[0004] If clamping can be achieved through the implantation of instruments under direct vision in minimally invasive surgery, thereby simplifying surgical procedures, reducing operation time, and lowering surgical complications, it will undoubtedly greatly contribute to the improvement of medical technology, safety, efficiency, and quality. Summary of the Invention

[0005] The purpose of this invention is to provide a minimally invasive coronary artery-pulmonary artery fistula clamping device and its usage method in cardiac surgery. Through innovative stent catheter clamping technology and structural design, it enables effective clamping of coronary artery-pulmonary artery fistulas under minimally invasive direct vision in patients of all ages, thereby simplifying surgical procedures, shortening the duration, reducing complications, and providing a new approach to the treatment of this disease.

[0006] According to the purpose of this invention, the present invention provides a minimally invasive coronary-pulmonary artery fistula clamping device for cardiac surgery, comprising: Inner sealing disc: It is a disc structure with a bottom surface of one-eighth of an arc, configured to be inserted into the pulmonary valve annulus; it includes a shape memory alloy stent outer layer, a composite material membrane-like occlusion inner layer, and a fixing disc; the bottom of the fixing disc is connected to a thin metal wire; the shape memory alloy stent outer layer has temperature-responsive plasticity, and when bent, it completely conforms to the inner wall of the pulmonary artery. Outer closed disc: The side is a disc-shaped structure with an arc of one-eighth, the bottom is provided with a layered corrugated band, and the top is provided with a groove; Control lock: includes a base plate and a spinning plate; the base plate is a hard circular plate with an externally threaded post, adapted to be embedded in the groove; the spinning plate is a hard circular plate with a prismatic hollow tube, screwed onto the externally threaded post; Guide sheath: The inner sealing disc, which is compressed into a column shape and integrated with a lifting guide line, is built into the conduit.

[0007] Further, the thin metal wire is sequentially threaded through the fistula hole, the base disc and the hollow tube of the spinning disc, thereby forming a linkage closed channel.

[0008] Further, the screwing depth of the spinning disc and the base disc linearly adjusts the clamping pressure of the outer closing disc on the blood vessel wall.

[0009] Further, the outer layer of the memory alloy support is a nickel-titanium alloy covered stent, and the phase change temperature is set to 33-37 DEG C.

[0010] Further, the bottom of the fixed disc is connected with a bald needle-like screw cap, and the thin metal wire is fixed to the screw cap.

[0011] According to another purpose of the present application, the present application provides a use method of the above-mentioned minimally invasive coronary artery-pulmonary artery fistula closure device, comprising the following steps: (a) exposing the pulmonary artery through a minimally invasive incision, and inserting a guide wire into the fistula hole; (b) pushing the guide sheath along the guide wire into the pulmonary artery, releasing the inner sealing disc and pulling the guide wire to make it adhere to the inner end of the fistula hole; (c) sliding the outer closing disc along the guide wire to make the corrugated belt adhere to the outer wall of the pulmonary artery; (d) embedding the base disc into the groove of the outer closing disc, and guiding the thin metal wire to sequentially pass through the fistula hole, the base disc and the spinning disc; (e) screwing the spinning disc to the preset pressure value, and completing the cooperative clamping inside and outside the fistula.

[0012] Further, in step (b), the memory alloy support of the inner sealing disc is plastically adhered by body temperature.

[0013] Further, in step (e), the screwing depth of the spinning disc is quantitatively controlled by a torque controller.

[0014] Further, in step (a), the puncture point is selected from the middle of the cluster-shaped blood vessel cluster formed by the coronary artery fistula in the pulmonary artery wall.

[0015] The present application has the following beneficial effects: The present application can reduce the myocardial infarction, occluder embolism and other complications caused by the prior art, avoid postoperative coronary artery expansion and residual fistula problems, simplify the operation steps, maximize the operation time, and benefit the postoperative rehabilitation of patients; The present application is suitable for a wide range of people, and all age groups of coronary artery-pulmonary artery fistula patients can benefit from it; The present application does not require extracorporeal circulation and heart arrest, avoids pulmonary artery incision trauma, provides a new idea for the treatment of the disease, and greatly helps to improve medical technology, safety, efficiency and quality. BRIEF DESCRIPTION OF DRAWINGS

[0016] Figure 1 The present application is a structural schematic diagram of an embodiment. Figure 2 This is a schematic diagram of the internal sealing disc structure in an embodiment of the present invention; Figure 3 This is a schematic diagram of the external closed disc in an embodiment of the present invention; Figure 4 This is a schematic diagram of the control lock structure according to an embodiment of the present invention; Figure 5 This is a schematic diagram of the guide sheath and inner sealing disc according to an embodiment of the present invention; In the diagram: 1. Inner sealing disc; 101. Outer layer of shape memory alloy support; 102. Inner layer of composite material membrane sealing. 2. External closing disc; 201. Corrugated belt; 202. Groove; 3. Control lock; 301. Base plate; 302. Spinning plate; 4. Guiding sheath; 5. Metal wire; 6. Pulmonary valve. Detailed Implementation

[0017] The specific embodiments of the present invention will be further described below. It should be noted that these descriptions are for the purpose of aiding understanding the present invention, but do not constitute a limitation thereof. Furthermore, the technical features involved in the various embodiments of the present invention described below can be combined with each other as long as they do not conflict with each other.

[0018] Example 1 like Figures 1-5 As shown, this invention innovatively uses stent catheter clipping technology to correct coronary artery-pulmonary artery fistula, and designs a coronary artery-pulmonary artery fistula clipping device that can be performed via a minimally invasive surgical approach or under ultrasound guidance. Specifically, a minimally invasive coronary artery-pulmonary artery fistula clamping device for cardiac surgery consists of four parts: an inner sealing disc 1, an outer sealing disc 2, a control lock 3, and a guide sheath 4. Among them, the inner sealing disc 1, the outer sealing disc 2, and the control lock 3 are medical implantable consumables, namely an integrated coronary artery-pulmonary artery fistula clamping device, and the guide sheath 4 is the main body of the implantation auxiliary device for the inner sealing disc of the clamping device chassis.

[0019] The inner sealing disc 1 is a disc-like insertion structure with a bottom surface that is one-eighth of an arc. It can extend into the pulmonary artery and be secured to the annulus of the pulmonary valve (i.e., inside the valve pocket). It consists of an inner layer and an outer layer, with a small fixed disc in the middle. A thin metal wire 5 is connected to the bottom of the disc. The outer part of the inner sealing disc 1 (the part away from the pulmonary artery wall during use) is the main body of the catheter stent. This structure is an endometrial stent, with a shape memory alloy outer layer 101. The stent is flexible and highly malleable, and can be tightly attached to the vessel wall and molded when the temperature is suitable. The overall malleability is in a bending state, completely conforming to the pulmonary artery wall. The inner part of the inner sealing disc 1 (the part close to the pulmonary artery wall during use) is a membrane structure made of composite material, which is the composite material membrane-like sealing inner layer 102, and plays a sealing role.

[0020] The external closure disc 2 is a disc-shaped structure with a certain curvature (about one-eighth of a circle) when viewed from the side. The bottom (the part that is close to the pulmonary artery wall when in use) has a layered corrugated band 201, and the top of the external closure disc 2 (the part that is away from the pulmonary artery wall when in use) has a groove 202 in the middle, which can be used to lock the adjustment lock into the groove 202 for fixation.

[0021] The control lock 3 is divided into two parts: a base plate 301 and a spinning plate 302. The base plate 301 is a circular rigid device that can be inserted into the groove on the top of the outer closing plate along the guide wire. It has a cylindrical body with a circular thread in the middle. The spinning plate 302 is another circular rigid device with a hollow tube with prismatic protrusions in the middle. It can be inserted into the cylindrical protrusions of the base plate.

[0022] The guide sheath 4 is the main body of the implantation auxiliary device for the inner sealing plate of the clamping device chassis, and there is a tightened columnar inner sealing plate inside the tube.

[0023] The main operating methods of this device are as follows: After coronary angiography or ultrasound examination confirms the diagnosis of coronary artery-pulmonary artery fistula, the clustered coronary arteries on the surface of the pulmonary artery are directly visualized through a minimally invasive small incision. A rigid puncture needle is used to puncture the pulmonary artery from the middle of the clustered coronary artery plexus (at the fistula opening), a guidewire is inserted, the rigid needle is withdrawn, and a guiding sheath is used to extend the head of the guidewire deep into the pulmonary artery before releasing the inner sealing disc. The guide wire in the middle of the guiding sheath is then pulled to make the inner sealing disc adhere tightly to the inner wall of the pulmonary artery, thereby sealing the internal opening. After tightening the guide line, slide the outer closure disc down along the guide line and place it on the surface of the pulmonary artery wall. Then, insert the base disc into the groove at the top of the outer closure disc along the guide line. Pass the thin metal wire connected to the inner sealing disc through the fistula opening and the base disc, and then through one side of the compression disc. Finally, slide the compression disc down along the guide line and tighten it on the base disc, ensuring the outer closure disc adheres as closely as possible to the pulmonary artery wall to clamp the collateral branches of the lateral coronary artery fistula. The thin metal wire allows the outer closure disc and the inner sealing disc to interact, completely clamping the coronary artery fistula. The clamping force is adjusted by the depth of the base disc and compression disc knobs.

[0024] Embodiment 2 As shown in the figure, the structure of this embodiment is basically the same as that of Embodiment 1. This embodiment is a minimally invasive coronary-pulmonary artery fistula closure device, which comprises an inner sealing disc 1, an outer closing disc 2, a control lock 3, and a guide sheath 4. The inner sealing disc, the outer closing disc, and the control lock are medical implant consumables, and the guide sheath is an implantation auxiliary device for the inner sealing disc of the closure device. Figures 1-5 The inner sealing disc 1 is a disc-shaped implant structure that can be inserted into the pulmonary artery and clamped on the annulus of the pulmonary valve 6. It is divided into an inner layer and an outer layer, with a fixed disc in the middle. The bottom of the disc has a bald needle-shaped screw cap connected to a thin metal wire. The outer layer of the inner sealing disc is a membrane stent made of memory alloy. The stent is soft and has strong plasticity. It can closely adhere to the pipe wall and be shaped when the temperature is appropriate. The overall shape is curved to fit the pulmonary artery wall. The inner layer of the inner sealing disc is a membrane structure made of composite material, which plays a sealing role. The bald needle-shaped screw cap at the bottom of the fixed disc of the inner sealing disc is connected to a thin metal wire for auxiliary operation. The outer closing disc 2 is a disc-shaped structure with an arc. The bottom has a corrugated strip, and the top has a groove in the middle. The side view of the outer closing disc has an eighth of a circular arc. The groove in the middle of the top of the outer closing disc can clamp and fix the control lock. The spinning disc is a hard disc-shaped device with a hollow tube with a ridge-shaped protrusion in the middle, which can be clamped onto the columnar protrusion of the base disc.

[0025] The control lock 3 is divided into a base disc 301 and a spinning disc 302. The base disc 301 can be clamped into the groove of the outer closing disc, and the spinning disc 302 can be fixed with the base disc. The base disc is a hard disc-shaped device with a columnar body with an external circular thread in the middle. The base disc can be clamped into the groove at the top of the outer closing disc along the guide wire. The spinning disc can be slid down along the guide wire and rotated tightly with the base disc to adjust the clamping force.

[0026] The guide sheath has a tightened inner sealing disc in the pipeline.

[0027] A coronary-pulmonary artery fistula closure method using the above device includes the following steps: after the patient completes the examination and confirms the diagnosis, the clustered coronary arteries on the surface of the pulmonary artery are observed under direct vision through a minimally invasive small incision. After puncturing into the pulmonary artery, the inner sealing disc is released by extending the guide wire with the guide sheath and deepening the head into the pulmonary artery. The inner sealing disc is tightly attached to the inner wall of the pulmonary artery by pulling the guide wire. After tightening the guide wire, the outer closing disc is slid down and placed on the surface of the pulmonary artery wall. The base disc is clamped into the groove at the top of the outer closing disc. The thin metal wire connected to the inner sealing disc passes through the fistula hole and the base disc, and then passes through one side of the spinning disc. The spinning disc is then rotated tightly with the base disc. The outer closing disc is tightly attached to the pulmonary artery wall to clamp the lateral branches on the outside, and the inner sealing disc interacts to completely clamp the coronary artery fistula.

[0028]

[0029] ​The above-mentioned examination includes coronary angiography or ultrasonic examination.

[0030] The puncture is performed from the middle of the cluster-shaped coronary plexus (fistula site) using a hard puncture needle.

[0031] The guide wire in the middle of the guide sheath is pulled after the inner sealing disc is released, so that the inner sealing disc is tightly attached to the inner wall of the pulmonary artery.

[0032] The clamping force is controlled by the depth of the base disc and the spinning disc knob.

[0033] The inner layer film structure of the inner sealing disc is made of composite material.

[0034] The top of the outer sealing disc is relatively smooth, and the circular clamping groove in the middle is adapted to the base disc.

[0035] The overall plasticity of the inner sealing disc is in a curved state, which can completely fit the pulmonary artery wall.

[0036] The device is used through a minimally invasive surgical approach or under ultrasonic guidance.

[0037] Example 3 The structure of the present embodiment is basically the same as that of the above-mentioned embodiments. The present embodiment is a minimally invasive coronary artery-pulmonary artery fistula clamping device for cardiac surgery, and its structure is as described in the above technical solutions. In actual application, the parameters of each part of the device can be appropriately adjusted according to the conditions of different patients. For example, the size of the disc-like structure of the inner sealing disc can be designed according to the size of the patient's pulmonary valve ring to ensure that it can be smoothly clamped on the valve ring; the curvature and size of the outer sealing disc can be adapted to the morphology of the pulmonary artery wall of different patients; the cooperation size of the base disc and the spinning disc needs to be accurate to ensure effective control of the clamping force.

[0038] During the operation, first, the patient is given a comprehensive preoperative examination, including coronary angiography and ultrasonic examination, to accurately determine the location and size of the coronary artery-pulmonary artery fistula. Then, under a minimally invasive small incision, the device is gradually implanted according to the above-mentioned operation mode through direct vision or ultrasonic guidance. During the release of the inner sealing disc, attention should be paid to temperature control to ensure that it can be tightly attached to the pulmonary artery wall; when installing the outer sealing disc, base disc and spinning disc, the connection between the parts should be firm to achieve good clamping effect.

[0039] After the operation, the patient is closely observed to monitor the postoperative recovery, including whether there is coronary artery dilatation, residual fistula, etc., to evaluate the effect of the operation.

[0040] Compared with the prior art, the present application reduces many complications brought by the prior art; simplifies the operation steps and reduces the operation time; the surgical instrument consumables are suitable for a wide range of people, and patients of all ages with coronary-pulmonary artery fistula can benefit from it; and the technology can provide a new treatment idea for the treatment of coronary-pulmonary artery fistula.

[0041] The present application realizes the minimally invasive direct vision coronary-pulmonary artery fistula clipping surgery of all ages, which greatly avoids the problems of postoperative coronary expansion and residual fistula; at the same time, the inside and outside of the coronary-pulmonary artery fistula and the surrounding collateral can be closed, which can avoid the damage during extracorporeal circulation and cardiopulmonary bypass, and also avoid the trauma caused by pulmonary artery incision; through the implantation of the integrated instrument, the operation steps are simplified, the operation time is minimized, and the patient's postoperative rehabilitation is facilitated.

[0042] Although embodiments of the present application have been shown and described, it is to be understood that various modifications, substitutions, replacements and changes can be made to these embodiments without departing from the principles and spirit of the present application, and the scope of the present application is defined by the appended claims and their equivalents.

Claims

1. A minimally invasive coronary-pulmonary artery fistula clamping device for cardiac surgery, characterized in that, include: Inner sealing disc: It is a disc structure with a bottom surface of one-eighth of an arc, configured to be inserted into the pulmonary valve annulus; it includes a shape memory alloy stent outer layer, a composite material membrane-like occlusion inner layer, and a fixing disc; the bottom of the fixing disc is connected to a thin metal wire; the shape memory alloy stent outer layer has temperature-responsive plasticity, and when bent, it completely conforms to the inner wall of the pulmonary artery. Outer closed disc: The side is a disc-shaped structure with an arc of one-eighth, the bottom is provided with a layered corrugated band, and the top is provided with a groove; Control lock: includes a base plate and a spinning plate; the base plate is a hard circular plate with an externally threaded post, adapted to be embedded in the groove; the spinning plate is a hard circular plate with a prismatic hollow tube, screwed onto the externally threaded post; Guide sheath: The inner sealing disc, which is compressed into a column shape and integrated with a lifting guide line, is built into the conduit.

2. The minimally invasive coronary-pulmonary artery fistula clamping device for cardiac surgery according to claim 1, characterized in that, The fine metal wires pass through the hollow tubes of the fistula, base plate, and spinning plate in sequence, forming a linkage and locking channel.

3. The minimally invasive coronary-pulmonary artery fistula clamping device for cardiac surgery according to claim 1, characterized in that, The threaded connection depth between the spinning disc and the base disc linearly adjusts the clamping pressure of the external closure disc on the blood vessel wall.

4. The minimally invasive coronary-pulmonary artery fistula clamping device for cardiac surgery according to claim 1, characterized in that, The outer layer of the shape memory alloy scaffold is a nickel-titanium alloy coated scaffold, and the phase transition temperature is set to 33-37℃.

5. The minimally invasive coronary-pulmonary artery fistula clamping device for cardiac surgery according to claim 1, characterized in that, The bottom of the fixed disc is connected to a bald-head needle-like nut, and the thin metal wire is fixed to the nut.

6. The method of using the minimally invasive coronary-pulmonary artery fistula clamping device according to claims 1-5, characterized in that, Includes the following steps: (a) The pulmonary artery is exposed through a minimally invasive incision, and a guidewire is inserted through the fistula. (b) Push the guide sheath along the guidewire into the pulmonary artery, release the inner sealing disc and pull the guide wire to seal the inner end of the fistula against the wall; (c) Slide along the guide line into the outer occluder disc so that its corrugated band adheres to the outer wall of the pulmonary artery; (d) Insert the base plate into the groove of the outer closed plate and guide the thin metal wire through the fistula hole, the base plate and the spinning plate in sequence; (e) Tighten the pressure plate to the preset pressure value to complete the coordinated clamping of the fistula inside and outside.

7. The method of using the minimally invasive coronary-pulmonary artery fistula clamping device according to claim 6, characterized in that, In step (b), the shape memory alloy scaffold of the inner sealing disc is plastically attached to the wall by body temperature.

8. The method of using the minimally invasive coronary-pulmonary artery fistula clamping device according to claim 6, characterized in that, In step (e), the tightening depth of the spinning disc is quantitatively controlled by the torque controller.

9. The method of using the minimally invasive coronary-pulmonary artery fistula clamping device according to claim 6, characterized in that, In step (a), the puncture site is selected from the middle of the cluster of blood vessels formed by the coronary artery fistula in the pulmonary artery wall.

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