WO2021190547A1 - Improved atrial septal stoma device - Google Patents

Abstract

Provided is an improved atrial septal stoma device (100) for ablating tissue surrounding a perforation (501) on an atrial septum. The improved atrial septal stoma device (100) comprises a catheter body (20) and a stoma body (40) arranged at the distal end of the catheter body (20), wherein the stoma body (40) comprises a cryoballoon (42), with the outer wall of the cryoballoon (42) being provided with a stoma portion (420) in the circumferential direction thereof, and a lumen of the cryoballoon (42) being filled with a refrigerant, such that the stoma portion (420) makes contact with the tissue surrounding the perforation (501) to cause irreversible damage, so as to prevent the perforation (501) from healing or shrinking.

Description

Improved atrial septal stoma device Technical field

This application relates to the technical field of interventional medical devices, and in particular to an improved atrial septostomy device for percutaneous intervention.

Background technique

Heart failure (abbreviated as heart failure) is a group of complex clinical syndromes in which the ventricular filling or ejection ability is impaired due to any abnormality in the structure or function of the heart. The main clinical manifestations are dyspnea and fatigue (restricted activity tolerance), and Fluid retention (pulmonary congestion and peripheral edema). Heart failure is the severe and terminal stage of various heart diseases, with a high incidence, and is one of the most important cardiovascular diseases today. According to the location of heart failure, it can be divided into left heart, right heart and total heart failure.

Heart failure is a serious disease with a high incidence and fatality rate. The incidence of heart failure in my country is 2-3%, which is above 12 million. The main causes of heart failure are hypertension, coronary heart disease, myocardial infarction, heart valve disease, atrial fibrillation, cardiomyopathy, etc. Cardiovascular disease causes damage to the left ventricle, leading to pathological remodeling of the left ventricle, resulting in hypofunction of the heart. Every time a patient with a myocardial infarction is successfully treated, a potential heart failure patient is brought.

In terms of treatment, after optimizing the drug treatment, the patient's symptoms are still recurrent, and the current drug treatment is almost only effective for patients with reduced ejection fraction, and the effect is not ideal for patients with preserved ejection fraction. Cardiac resynchronization therapy is not suitable for all patients with heart failure, and more than 20% of patients are ineffective for cardiac resynchronization pacing. Left ventricular assist device surgery requires extracorporeal circulation and has a high incidence of major traumatic complications, which is expensive and difficult to obtain. Heart transplantation is the ultimate solution, but the source of donors is very limited and expensive.

Atrial septal ostomy is a stoma in the patient's atrial septum to form a shunt between the left and right heart chambers. It can be used to treat pulmonary hypertension (right-to-left shunt) or left heart failure (left-to-right shunt), and it has been clinically proven Effectiveness.

Drug therapy cannot cure atrial fibrillation, nor can it prevent its occurrence, and the long-term effect is not good. Atrial septal ostomy combined with radiofrequency ablation is the first choice for the treatment of atrial fibrillation and heart failure. However, traditional radiofrequency ablation achieves the purpose of tissue damage by destroying the integrity of the tissue structure. Thrombus and thromboembolism at the wound may occur. disease.

Summary of the invention

In view of this, the purpose of this application is to provide an improved atrial septostomy device.

In order to solve the above technical problems, the present application provides an improved atrial septostomy device for ablating surrounding tissues perforated in the atrial septum. The improved atrial septostomy device includes a catheter body and a catheter body disposed on the catheter body. The ostomy body at the distal end of the ostomy body includes a freezing balloon, the outer wall of the freezing balloon is provided with a stoma portion along the circumferential direction, and the inner cavity of the freezing balloon is filled with refrigerant to make the stoma The part contacts the surrounding tissue of the perforation to cause irreversible damage to prevent the perforation from healing or shrinking.

The stoma of the improved atrial septostomy device of the present application contacts the surrounding tissues of the perforation, and after filling the inner cavity of the cryo-balloon with cryogen, the temperature of the stoma can be quickly reduced to below -30 degrees, thereby making Ice crystals are formed in the surrounding tissues of the perforation to cause dehydration of the cardiomyocytes to cause necrotic structural destruction; while the ice crystals melt during the rewarming phase, resulting in microcirculation disturbances, secondary damage to the surrounding tissues of the perforation, and finally contact with the stoma. The tissue surrounding the perforation is irreversibly damaged to complete the ablation of the tissue surrounding the perforation to prevent the perforation from healing or shrinking. The ablation of the atrial septal tissue by freezing energy is safer than radio frequency energy. The surrounding tissue damage caused by the freezing energy is more uniform and the boundary is clearer, and it does not cause eschar and gasification burst related to high temperature effect. And collagen degeneration contracture can better preserve the structural integrity of the stoma; and studies have shown that during cryoablation, although collagen activation can occur, continuous platelet activation is not observed, and the cell surface at the ablation site is relatively smooth and smooth. It shows that cryoablation reduces the probability of thrombus attachment and improves the smoothness of blood flow through the atrial septal stoma.

Description of the drawings

In order to explain the technical solutions of the embodiments of the present application more clearly, the following will briefly introduce the drawings that need to be used in the embodiments. Obviously, the drawings in the following description are some embodiments of the present application, which are common in the field. As far as technical personnel are concerned, they can also obtain other drawings based on these drawings without creative work.

Fig. 1 is a schematic structural diagram of an improved atrial septostomy device provided by the first embodiment of the present application;

Fig. 2 is a schematic diagram of the state of use of the improved atrial septostomy device in Fig. 1;

Fig. 3 is a schematic structural diagram of an improved atrial septostomy device provided by a second embodiment of the present application;

Fig. 4 is a schematic diagram of the state of use of the improved atrial septostomy device in Fig. 3;

5 is a schematic structural diagram of an improved atrial septostomy device provided by the third embodiment of the present application;

6 is a schematic structural diagram of another improved atrial septostomy device provided by the third embodiment of the present application;

Fig. 7 is a schematic diagram of the use state of the improved atrial septostomy device in Fig. 5;

8 is a schematic structural diagram of an improved atrial septostomy device provided by the fourth embodiment of the present application;

Figure 9 is a schematic diagram of the improved atrial septostomy device in Figure 8 in use;

Fig. 10 is a schematic structural diagram of another improved atrial septostomy device provided by the fourth embodiment of the present application.

Detailed ways

The technical solutions in the embodiments of the present application will be clearly and completely described below in conjunction with the accompanying drawings in the embodiments of the present application. Obviously, the described embodiments are only a part of the embodiments of the present application, rather than all the embodiments. Based on the embodiments in this application, all other embodiments obtained by a person of ordinary skill in the art without creative work shall fall within the protection scope of this application.

In the description of this application, it should be noted that the orientation or positional relationship indicated by the terms "upper", "lower", "inner", "outer" etc. is based on the orientation or positional relationship shown in the drawings, and is only for It is convenient to describe the application and simplify the description, instead of indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation of the application. In addition, the terms "first", "second", etc. are only used for descriptive purposes, and cannot be understood as indicating or implying relative importance.

In order to more clearly describe the structure of the wire locking system and the wire locking device, the limited terms "proximal", "distal" and "axial" described in this application are common terms in the field of interventional medicine. Specifically, "distal" refers to the end far away from the operator during the surgical operation; "proximal end" refers to the end close to the operator during the surgical operation; the proximal end in this application is relative to the distal end from the operator ( The distance between the surgeon) is relatively short. After the device is assembled, each component of the device includes a proximal end and a distal end, and the proximal end of each component is closer to the operator than the distal end. "Axial" refers to the direction of the central axis of the device, and the radial direction is the direction perpendicular to the central axis. Unless otherwise defined, all technical and scientific terms used in this application have the same meaning as commonly understood by those skilled in the technical field of this application. Conventional terms used in the specification of this application are only for the purpose of describing specific embodiments, and should not be construed as limiting the application.

It should be noted that when an element is referred to as being "disposed on" another element, the element can be directly connected to the other element, or indirectly connected to the other element through one or more connecting elements. When an element is said to be "connected" to another element, it can be directly connected to the other element or connected to the other element through one or more connecting elements.

Please also refer to FIG. 1, which is a schematic structural diagram of an improved atrial septostomy device 100 provided by the first embodiment of the present application. The present application provides an improved atrial septostomy device 100. As shown in FIG. 2, it is used to ablate the surrounding tissues of the perforation 501 on the atrial septum 500. The improved atrial septostomy device 100 includes a catheter body 20 and a catheter The ostomy body 40 at the distal end of the main body 20 includes a freezing balloon 42. The outer wall of the freezing balloon 42 is provided with a stoma 420 along the circumferential direction. The inner cavity of the freezing balloon 42 can be filled with a refrigerant to make The mouth 420 contacts the surrounding tissues of the perforation 501, causing irreversible damage to the surrounding tissues of the perforation 501. Specifically, after the inner cavity of the freezing balloon 42 is filled with refrigerant, the temperature of the stoma portion 420 is rapidly reduced to below -30 degrees, so that the temperature of the surrounding tissues of the perforation 501 that is in contact with the stoma portion 420 is rapidly reduced Below -30 degrees, ice crystals are formed in the surrounding myocardial tissue of the perforation 501 during the cooling stage, and the myocardial cells surrounding the perforation 501 are dehydrated and necrotic structure is destroyed. The ice crystals melt during the rewarming stage, resulting in microcirculation obstacles, which affect the surrounding tissues of the perforation 501. Produce secondary damage, and eventually lead to irreversible damage to the myocardial tissue.

In this embodiment, the liquid refrigerant filled into the inner cavity of the freezing balloon 42 can be selected from liquid nitrogen, nitrous oxide, carbon dioxide, methane, ethane, butane, propane, chlorofluorocarbons, and hydrochlorofluorocarbons. The refrigerant of its mixture fills the balloon.

The stoma portion 420 of the improved atrial septostomy device 100 of the present application contacts the surrounding tissues of the perforation 501, and after filling the inner cavity of the cryo-balloon 42 with refrigerant, the temperature of the stoma portion 420 can be quickly reduced to -30 Temperature below the perforation 501, so that the surrounding tissues of the perforation 501 will form ice crystals, so that the cardiomyocytes will be dehydrated and the necrotic structure will be destroyed; and the ice crystals will melt during the rewarming stage, which will cause microcirculation disturbances, and cause secondary damage to the surrounding tissues of the perforation 501, which will eventually lead to The myocardial tissue is irreversibly damaged to complete the ablation of the surrounding tissues of the perforation 501. The ablation of the atrial septal tissue by freezing energy is safer than radio frequency energy. The internal fibrosis of the surrounding tissue damage of the perforation 501 formed by the freezing energy is more uniform, the boundary is clearer, and it does not cause eschar and gasification related to high temperature effects. Burst and contracture of collagen degeneration can better preserve the structural integrity of the stoma. And studies have shown that in the process of cryoablation, although collagen activation may occur, continuous platelet activation is not observed, and the cell surface of the ablation site is relatively smooth and smooth, indicating that cryoablation reduces the probability of thrombus adhesion and improves blood flow through The smoothness of the atrial septal stoma.

The catheter body 20 is provided with a guide wire cavity 22 along the axial direction. The guide wire cavity 22 is a hollow and elongated cavity, and the guide wire cavity 22 is used to guide the guide wire through. The distal end of the catheter body 20 is sealed with the edge of the guidewire lumen 22, the proximal end of the catheter body 20 is provided with a perfusion port 24, the catheter body 20 is provided with a number of injection ports 25 in the cryo-balloon 42, and the catheter body 20 is provided axially The infusion channel (not shown in the figure) that connects the injection port 24 and the injection ports 25; the injection port 24 is connected to the cryoablation instrument, and the refrigerant is injected from the injection port 25 to the cryosphere through the injection port 24 and the infusion channel The inner cavity of the balloon 42 is filled with the frozen balloon 42 so that the stoma 420 is supported on the surrounding tissues of the perforation 501.

The catheter main body 20 can be made of high-strength thin-walled tubing such as polytetrafluoroethylene, polyethylene or polyurethane to reduce the space occupied by the pipe wall of the catheter main body 20; the catheter main body 20 is used to support the freezing balloon 42 and pass the infusion The port 24 delivers refrigerant into the freezing balloon 42.

After the cryo-balloon 42 is filled, the cryo-balloon 42 is cylindrical, and the stoma portion 420 is the part of the wall where the cryo-balloon 42 is in contact with the atrial septum 500 tissue; preferably, the stoma portion 420 is the cryo-balloon 42 along the axial direction. The outer wall near the center position.

The cryo-balloon 42 may be a non-compliant balloon. When the cryo-balloon 42 straddles the atrial septum 500 and is filled, the radial dimension of the stoma 420 is equal to or greater than the radial dimension of the perforation 501, and the cryo-balloon 42 The stoma portion 420 of the perforation part 420 supports and expands the surrounding tissues of the perforation 501, so that the radial dimension of the stoma after ablation is close to the radial dimension of the non-compliant balloon, and prevents the perforation 501 from being excessively reduced.

The frozen balloon 42 may also be a compliant balloon. Specifically, the frozen balloon 42 is made of a polymer material and has an elastic cylindrical balloon structure. The radial size of the frozen balloon 42 varies with the size of the refrigerant. The filling changes; that is, the radial size of the stoma 420 changes with the filling of the refrigerant. In other words, the radial size of the stoma portion 420 of the cryo-balloon 42 can be adjusted by the amount of refrigerant input to form stomas of different radial sizes. Preferably, the polymer material may include, but is not limited to, polyethylene (PE), polyethylene terephthalate (PET), nylon, polyurethane, and the like.

As shown in FIG. 1, a plurality of injection ports 25 are enclosed in at least one circle along the circumference of the catheter main body 20, and each injection port 25 is connected to the infusion channel in the catheter main body 20. Specifically, at least one circle of injection ports 25 is opened in the freezing balloon 42 and along the circumference of the catheter body 20. In this embodiment, a circle of injection ports 25 is opened in the vicinity of the stoma portion 420 and along the circumference of the catheter body 20. The number of injection ports 25 in a circle is six, and the six injection ports 25 are along the circumferential direction of the catheter body 20. Evenly arranged, the six injection ports 25 are all connected to the infusion channel in the catheter body 20.

Preferably, the several injection ports 25 are close to or face the central position of the stoma 420 in the axial direction.

In other embodiments, the outer wall of the catheter body 20 corresponding to the middle of the stoma portion 420 in the cryo-balloon 42 is provided with two or more injection ports 25, and the two or more injection ports 25 are along the axial direction. The injection ports 25 are arranged at intervals, and each circle of injection ports 25 is arranged along the circumferential direction of the catheter body 20. Preferably, a spray tube (not shown in the figure) protrudes from the outer wall of the conduit main body 20 around each spray port 25, and each spray tube extends in a direction perpendicular to the axial direction. The corresponding spray port 25 is connected, so that the outlet of the spray pipe is closer to the stoma part 420 of the interatrial septum, which is more conducive to spraying the refrigerant to the stoma part 420 to quickly absorb heat.

In other embodiments, the outer wall of the catheter body 20 corresponding to the middle, proximal and distal ends of the stoma portion 420 in the cryo-balloon 42 is provided with at least one circle of injection ports 25, and each circle of injection ports 25 runs along the catheter body. 20 is evenly arranged in the circumferential direction, so that the refrigeration of the stoma 420 is more uniform. Preferably, the outer wall of the catheter body 20 is provided with a spray tube protruding around each spray port 25, the middle spray tube extends in a direction perpendicular to the axial direction, and the proximal and distal spray tubes are inclined along the axis. It extends toward the middle part of the stoma 420 so that the outlet of each spray tube is closer to the stoma 420 of the interatrial septum, which is beneficial to spray the refrigerant to the stoma 420 to quickly absorb heat.

In this embodiment, the proximal edge and the distal edge of the cryo-balloon 42 are sealed to the outer wall of the catheter body 20, and the inner surface of the cryo-balloon 42 and the outer peripheral surface of the catheter body 20 form an inner cavity of the cryo-balloon 42 , The refrigerant is filled into the inner cavity. Specifically, the proximal edge and the distal edge of the cryo-balloon 42 can be sealed to the outer wall of the catheter body 20 by means of gluing, clamping, or the like.

A recovery port 26 is opened at the proximal end of the catheter main body 20 in the refrigerated balloon 42. The recovery port 26 is connected to the inner cavity of the refrigerated balloon 42. The catheter main body 20 is axially provided with a receiving channel connected to the recovery port 26 (not shown in the figure). (Shown), the receiving channel is used to recover the refrigerant in the inner cavity of the freezing balloon 42. Specifically, the hole diameter of the recovery port 26 is larger than the hole diameter of the ejection port 25 so as to facilitate the removal of the coolant and/or expansion fluid consumed by the inner cavity of the freezing balloon 42.

In other embodiments, the cryo-balloon 42 includes an inner balloon wall sealingly sleeved on the catheter body 20 and an outer balloon wall connected to the proximal and distal ends of the inner balloon wall, the inner balloon wall and the outer balloon wall The inner cavity of the freezing balloon 42 is enclosed, and the inner wall of the inner balloon is provided with a through hole communicating with the injection port 25 of the catheter main body 20 and a discharge hole communicating with the recovery port 26 of the catheter 20.

Please refer to Figure 1 and Figure 2 together. The improved atrial septostomy device 100 in this application needs to be used in combination with a support tube, a pusher, etc., and the method of use is as follows:

After the interatrial septum 500 is punctured, a perforation 501 is formed, the guide wire is fed into the left upper pulmonary vein, and the puncture kit is removed; the support tube is pushed along the guide wire into the left atrium, and the guide wire is removed.

Choose an improved atrial septostomy device 100 of a suitable size, push the pusher forward, and transport the stoma body 40 into the perforation 501 of the atrial septum 500, and expand the stoma 420 to resist the expansion of the tissue at the perforation 501 to form a With a shunt channel of a specific size (judged by ultrasound or DSC), the stoma 420 contacts the surrounding tissue of the perforation 501.

The refrigerant is sprayed from the spray port 25 to the inner cavity of the freezing balloon 42 through the filling port 24 of the catheter body 20 and the infusion channel. The liquid refrigerant is ejected from the injection port 25 toward the freezing balloon 42 and then quickly vaporized, so that the refrigerant fills the freezing balloon 42 and absorbs the heat of the surrounding tissues during the volatilization process, that is, the refrigerant enters the freezing balloon 42 through the refrigerant. The liquid-to-air transition occurs and absorbs the heat of the surrounding tissues and fills the frozen balloon 42 during the volatilization process, so that the temperature of the atrial septal tissue contacted by the stoma 420 quickly drops below -30°C, and cryoablation is achieved through the stoma 420, making the target The temperature of the tissue at the ablation site is lowered and then rewarmed; in the cooling phase, ice crystals are formed in the tissue at the ablation site, which causes dehydration of cardiomyocytes and damages the necrotic structure; during the rewarming stage, the ice crystals melt, leading to microcirculation obstacles and secondary damage. Eventually lead to irreversible damage to the tissue at the ablation site.

Stop spraying the refrigerant, discharge the refrigerant in the inner cavity of the freezing balloon 42 through the recovery port 26 and the receiving channel of the catheter body 20, then remove the ostomy body 40 and the catheter body 20 from the body, and measure whether the diameter of the stoma is Reached the preset.

In the improved atrial septostomy device 100 of the present application, during the ablation of the tissue around the perforation 501 by the stoma 420, the rapid cooling of the stoma 420 is used to form ice crystals in the surrounding tissues of the perforation 501 to dehydrate the cardiomyocytes. The destruction of the necrotic structure occurs, and the ice crystals melt during the rewarming stage, resulting in microcirculation obstacles and secondary damage to the surrounding tissues of the perforation 501 to ablate the surrounding tissues of the perforation 501. It is safer to ablate the tissues of the interatrial septum by freezing energy. The internal fibrosis of the tissue around the stoma formed by the freezing energy is more uniform, the boundary is clearer, and it does not cause eschar, vaporization burst and collagen related to the high temperature effect. Degenerative contracture can better preserve the structural integrity of the stoma. In addition, the cell surface of the ablation site is relatively smooth and smooth, indicating that cryoablation reduces the probability of thrombus attachment and improves the smoothness of blood flow through the atrial septostomy.

Please refer to FIGS. 3 and 4 together. FIG. 3 is a schematic diagram of the improved atrial septostomy device 100a provided by the second embodiment of the present application; FIG. 4 is the use of the improved atrial septostomy device 100a in FIG. 3 State diagram. The structure of the improved atrial septostomy device 100a provided by the second embodiment of the present application is similar to the structure of the first embodiment, except that the ostomy body 40 in the second embodiment further includes a positioning member, which is specifically as follows:

The proximal end and/or the distal end of the stoma portion 420 of the cryo-balloon 42 are provided with a positioning member 422 for positioning to the proximal and/or distal surface of the perforation 501 in the interatrial septum 500. In use, after the cryo-balloon 42 is inserted into the perforation 501 and filled, the positioning member 422 at the proximal end of the stoma 420 abuts against the proximal surface of the atrial septum 500, and the positioning member 422 at the distal end of the stoma 420 abuts Abutting on the distal surface of the atrial septum 500 to ensure that the atrial septal tissue 500 and the stoma 420 are not prone to relative displacement during surgical ablation, that is, to restrict the movement of the cryo-balloon 42 relative to the atrial septum 500 in the axial direction, which is convenient The stoma 420 fits the surrounding tissues of the perforation 501, which can enhance the cryoablation of the tissue at the atrial septal stoma, and further prevent cell recovery and stoma healing.

In this embodiment, the positioning member 422 is a plurality of solid convex points protruding from the outer wall of the stoma portion 420, and the plurality of convex points form a circle along the circumference of the stoma portion 420. Specifically, the proximal end and the distal end of the outer wall of the stoma portion 420 are respectively provided with a circle of convex points, and the convex points of each circle are evenly arranged along the circumferential direction of the stoma portion 420. Preferably, the number of convex points in each circle is six, and the six convex points are evenly arranged along the circumferential direction of the stoma portion 420, and each convex point is in a hemispherical shape.

In other embodiments, the positioning member 422 is a hollow annular protruding strip protruding from a circumference of the outer wall of the stoma portion 420, and the annular protruding strip forms a circle along the circumference of the stoma portion 420. Specifically, the proximal end and the distal end of the outer wall of the stoma portion 420 are respectively provided with an annular convex strip. When in use, after the cryo-balloon 42 is inserted into the perforation 501 and filled, the annular protrusion at the proximal end of the stoma portion 420 abuts against the proximal surface of the atrial septum 500, and the annular protrusion at the distal end of the stoma portion 420 abuts Abutting on the distal surface of the atrial septum 500 to ensure that the atrial septal tissue 500 and the stoma portion 420 are not prone to relative displacement during the ablation period.

In other embodiments, the positioning member 422 is a plurality of mutually spaced convex strips protruding from the outer wall of the stoma portion 420, and these convex strips enclose at least one circle along the circumference of the stoma portion 420. Specifically, the proximal end and the distal end of the outer wall of the stoma portion 420 are respectively provided with a circle of convex strips. In use, after the cryo-balloon 42 is inserted into the perforation 501 and filled, a circle of protruding strips at the proximal end of the stoma 420 abuts against the proximal surface of the atrial septum 500, and a circle of protruding strips at the distal end of the stoma part 420 abuts against the proximal surface of the atrial septum 500. Abutting on the distal surface of the atrial septum 500 to ensure that the atrial septal tissue 500 and the stoma portion 420 are not prone to relative displacement during the ablation period.

As shown in FIG. 4, the method of using the improved atrial septostomy device 100a in the second embodiment is the same as that of the improved atrial septostomy device 100 in the first embodiment, except that the stoma body 40 is delivered After the perforation 501 of the atrial septum 500 is filled with cryogen, the proximal and distal positioning pieces 422 of the stoma 420 abut against the proximal and distal surfaces of the atrial septum 500 to ensure the atrial septum. The contact between the tissue 500 and the stoma 420 during surgical ablation is unlikely to cause relative displacement.

Please refer to FIGS. 5-7 together. FIG. 5 is a schematic structural diagram of the improved atrial septostomy device 100b provided by the third embodiment of the present application; FIG. 7 is the use of the improved atrial septostomy device 100b in FIG. 5 State diagram. The structure of the improved atrial septostomy device 100b provided by the third embodiment of the present application is similar to that of the first embodiment, except that the cryo-balloon 42a in the third embodiment is formed by nesting two balloons into each other. The double-layer balloon is as follows:

The cryo-balloon 42a includes an inner balloon 425 and an outer balloon 426 nested in each other. The stoma 420 is the waist part of the outer wall of the outer balloon 426 that is indented in a circle in the circumferential direction; when the frozen balloon 42a is made When the mouth 420 straddles the perforation 501 of the atrial septal tissue 500 and is filled, the outer balloon 426 is supported on the atrial septal tissue 500 so that the radial dimension of the stoma 420 is equal to or greater than the radial dimension of the perforation 501. Specifically, the inner balloon 425 is cylindrical after being filled, and the outer balloon 426 is dumbbell-shaped after being filled. The outer balloon 426 supports and expands the atrial septal tissue 500, so that the size of the stoma is close to that of the stoma 420. Radial diameter.

The cryo-balloon 42a is disposed at the distal end of the catheter body 20. Specifically, the proximal and distal ends of the inner balloon 425 and the outer balloon 426 are all sealed to the outer wall of the catheter body 20, and the proximal and inner ends of the outer balloon 426 The proximal end of the balloon 425 is separated, and the proximal end of the outer balloon 426 is closer to the proximal end than the proximal end of the inner balloon 425; the distal end of the outer balloon 426 is separated from the distal end of the inner balloon 425, and the outer balloon The distal end of 426 is closer to the distal end than the distal end of the inner balloon 425. The inner surface of the outer balloon 426, the outer peripheral surface of the inner balloon 425, and the outer peripheral surface of the catheter body 20 between the outer balloon 426 and the inner balloon 425 enclose the inner cavity of the outer balloon 426; The surface and the outer peripheral surface of the catheter body 20 enclose the inner cavity of the inner balloon 425.

In this embodiment, the stoma portion 420 is located at the axial middle position of the outer balloon 426. The outer balloon 426 is provided with positioning portions 427 at the proximal and distal ends of the stoma portion 420, respectively. After the freezing balloon 42a is filled, The radial size of the positioning portion 427 is greater than the radial size of the stoma portion 420. Specifically, the diameter of the outer balloon 426 from the waist to the proximal end and/or the distal direction gradually increases, that is, positioning portions 427 are respectively formed on both sides of the waist of the outer balloon 426, and the diameter of the positioning portion 427 is larger than the diameter of the positioning portion 427. The diameter of the mouth 420.

As shown in FIG. 5, the catheter body 20 is provided with a plurality of first injection ports 251 communicating with the inner cavity of the outer balloon 426 and a plurality of second injection ports 253 communicating with the inner cavity of the inner balloon 425. The proximal end of the catheter body 20 is opened An infusion port 24, the catheter main body 20 is provided with an infusion channel (not shown) connecting the infusion port 24 with the first injection port 251 and the second injection port 253; the refrigerant passes through the injection port 24 and the infusion agent After the passage, spray from the first spray port 251 to the inner cavity of the outer balloon 426 and from the second spray port 253 to the inner cavity of the inner balloon 425 to fill the frozen balloon 42a and make the stoma 420 support the perforation 501 surrounding tissues. That is, the refrigerant is delivered to the first injection port 251 and the second injection port 253 through the same delivery channel.

Preferably, the plurality of first injection ports 251 are enclosed in at least one circle along the circumference of the catheter body 20, and the plurality of first injection ports 251 are adjacent to the distal end of the outer balloon 426; and the plurality of second injection ports 253 are along the circumference of the catheter body 20. Enclosed in at least one circle, a plurality of second injection ports 253 are close to the distal end of the stoma 420.

In other embodiments, the catheter body 20 is provided with a plurality of first injection ports 251 communicating with the inner cavity of the outer balloon 426 and a plurality of second injection ports 253 communicating with the inner cavity of the inner balloon 425, and the proximal end of the catheter body 20 is opened Two infusion ports, two spaced infusion channels are provided in the catheter body 20 along the axial direction, one of the infusion channels is connected to the first injection port 251 and the corresponding infusion port, and the other infusion channel is connected to the second injection port 253 With the corresponding perfusion port. That is, the outer balloon 426 and the inner balloon 425 are separately filled with cryogen through the two perfusion ports and the corresponding infusion channels to improve the delivery efficiency of cryogen, so that the stoma is supported by the surrounding tissues of the perforation 501.

The catheter body 20 is provided with a first recovery port 261 at the proximal end of the lumen of the outer balloon 426, the first recovery port 261 is connected to the lumen of the outer balloon 426, and the catheter body 20 is provided with a second recovery port at the proximal end of the lumen of the inner balloon 425 The port 263 and the second recovery port 263 are connected to the inner cavity of the inner balloon 425, and the catheter body 20 is provided with a receiving channel that communicates the first recovery port 261 and the second recovery port 263 along the axial direction. The refrigerant consumed in the outer balloon 426 and the inner balloon 425 is recovered through the first recovery port 261 and the second recovery port 263 and the receiving channel. That is, the first injection port 251 and the second injection port 253 are connected through the same receiving channel to recover the refrigerant.

In other embodiments, the catheter body 20 is provided with a first recovery port 261 at the proximal end of the inner cavity of the outer balloon 426, and the first recovery port 261 communicates with the inner cavity of the outer balloon 426; A second recovery port 263 is opened at the proximal end, and the second recovery port 263 is connected to the inner cavity of the inner balloon 425; the catheter body 20 is provided with two spaced receiving channels along the axial direction, and the two receiving channels are respectively connected to the first The recovery port 261 and the second recovery port 263. That is, the consumed refrigerant in the inner cavity of the outer balloon 426 and the consumed refrigerant in the inner cavity of the inner balloon 425 are separately recovered through the two receiving channels, thereby improving the recovery efficiency and separately controlling the volumes of the two inner cavities.

As shown in Figure 5, after the inner balloon 425 and the outer balloon 426 are both filled, the outer wall of the middle part of the inner balloon 425 abuts the stoma 420 of the outer balloon 426, and the inner balloon 425 is a non-compliant balloon. The internal chamber of the fluid coolant or fluid contained in the inner balloon 425 may be defined, and may be communicated with the second recovery port 263 for removing the consumed coolant or fluid from the inside of the inner balloon 425.

In other embodiments, as shown in FIG. 6, the catheter body 20 is only provided with a plurality of first injection ports 251 and first recovery ports 261 at the distal and proximal ends of the lumen communicating with the outer balloon 426, respectively, and the inner balloon The internal cavity of 425 does not communicate with refrigerant. When the outer balloon 426 is filled, the inner balloon 425 and the outer balloon 426 form a hollow cryo-balloon to freeze and ablate the atrial septal tissue, thereby improving the utilization efficiency of the refrigerant and speeding up the circulation of the refrigerant in the balloon speed. The outer balloon 426 can be made of non-compliant or compliant materials. When the outer balloon 426 is made of a compliant material, the amount of filling refrigerant in the inner cavity of the outer balloon 42 can be used to adjust the stoma 420. Radial size; when the outer balloon 426 is made of a non-compliant material, after the inner cavity of the outer balloon 42 is filled with refrigerant, the radial size of the stoma 420 is slightly greater than or equal to the diameter of the stoma.

In other embodiments, the outer balloon 426 is made of non-compliant or semi-compliant materials, and the inner balloon 425 is made of compliant materials. The radial dimension of the inner balloon 425 is adjusted to adjust the stoma 420. Radial size. The semi-compliant materials and non-compliant materials mainly include materials such as polyethylene (PE), polyurethane, nylon (Nylon, DuralynTM), and polyethylene terephthalate.

In other embodiments, the outer balloon 426 is made of a compliant material or a semi-compliant material, and the radial size of the stoma 420 is changed by increasing or decreasing the refrigerant filled into the inner cavity of the outer balloon 426.

In other embodiments, each first injection port 251 and each second injection port 253 of the catheter body 20 is connected with an injection tube, and the outlet of the injection tube faces the stoma 420. Preferably, each spray tube extends obliquely with respect to the catheter main body 420 so that the opening of the spray tube faces the middle of the stoma 420.

As shown in Figure 7, the method of using the improved atrial septostomy device 100b in the third embodiment is the same as that of the improved atrial septostomy device 100 in the first embodiment, except that the stoma body is delivered to After the perforation 501 of the atrial septum 500 is filled with cryogen, the proximal and distal positioning portions 427 of the stoma 420 abut against the proximal and distal surfaces of the atrial septum 500 respectively to ensure the atrial septal tissue The contact between 500 and the stoma 420 during surgical ablation is not easy to produce relative displacement; and the radial size of the stoma 420 is adjusted to obtain the desired stoma.

In other embodiments, the outer surface of the stoma portion 420 is provided with at least one circle of developing points or developing wires along its circumferential direction.

Please refer to FIGS. 8 and 9 together. FIG. 8 is a schematic structural diagram of an improved atrial septostomy device 100c according to a fourth embodiment of the present application; FIG. 9 is a use of the improved atrial septostomy device 100c in FIG. 8 State diagram. The structure of the improved atrial septostomy device 100c provided by the fourth embodiment of the present application is similar to that of the first embodiment, except that the cryo-balloon 42 in the fourth embodiment is provided with an independent positioning bracket. as follows:

The proximal end of the cryo-balloon 42 is provided with a positioning bracket 43 that can be released and retracted independently of the advancement of the cryo-balloon 42. The proximal end and/or the distal end of the positioning bracket 43 are provided with a positioning member 432 and a waist 430. The positioning bracket 43 is used for expansion and positioning to the proximal and/or distal surface of the perforation 501 on the interatrial septum 500. When in use, the positioning bracket 43 is pushed forward and released into the perforation 501, the positioning member 432 abuts against the proximal and/or distal surface of the atrial septum 500, and the outer wall of the waist 430 is close to the inner wall of the perforation 501. After the waist 430 expands the perforation 501 to within the target diameter range, the frozen balloon 42 is inserted into the perforation 501 and filled until the stoma is close to the inner wall of the waist 430 to ensure that the atrial septal tissue 500 and stoma 420 are in contact with each other. Contact during surgical ablation is not easy to produce relative displacement, that is, the cryo-balloon 42 is restricted from moving in the axial direction relative to the atrial septum 500, which facilitates the stoma to fit the surrounding tissues of the perforation 501, and strengthens the cryoablation of the tissue at the atrial septal stoma. , To further prevent cell recovery and stoma healing. After the cryoablation is completed, the cryo-balloon 42 can be withdrawn first, and the positioning stent 43 remains at the perforation 501 to continue to support it to prevent the tissue from re-warming and rebound, which can better maintain the shape of the stoma and facilitate further medical imaging observation of the stoma.

In this embodiment, the positioning bracket 43 may be a spherical expansion type or a self-expanding metal support frame or a non-metal support frame. The stent can be cut or braided by wire, or partly braided and partly cut by pipe. Different parts can be welded or fixed to each other by connecting pieces. The material of the pipe is a memory metal material or a biocompatible non-metallic material, such as low-temperature super-elastic Nitinol, TPEE and other low-temperature resistant materials, which can maintain elasticity at -30°C to -50°C and be easily recycled to the delivery sheath. . The overall shape of the positioning bracket 43 can also be a straight cylindrical shape, a disc shape, a cone shape, and other suitable shapes, which are not limited herein.

In this embodiment, the waist 430 includes, but is not limited to, a cylindrical shape with a plurality of supporting sheets 4301 arranged in the circumferential direction. Specifically, the plurality of supporting sheets 4301 are arrayed in a circular array along the axis of the cryo-balloon 42, each A supporting piece 4301 extends along the axis of the freezing balloon 42 and when the freezing balloon 42 is completely filled and the positioning stent 43 is completely released, each supporting piece 4301 at the waist 430 faces the frozen balloon 42. The mouth is concave and curved. A central hole 4302 is opened in the middle of each support piece 4301 to increase the exposed area of the stoma. The central hole 4302 is provided with imaging points. The imaging points in several central holes 4302 surround the frozen balloon 42 to facilitate navigation Position the stent 43 into the perforation of the interatrial septum. The developing point or the developing wire can be fixed by inlaying and hot pressing using gold, platinum, tantalum and other materials.

In this embodiment, when the positioning bracket 43 is completely released, the positioning member 432 includes a distal positioning member 432a and a proximal positioning member 432b, which are respectively positioned on two opposite sides of the interatrial septum. The distal positioning member 432a is located in the left atrium and abutting the atrial septal tissue around the perforation, and the proximal positioning member 432b is located in the right atrium and abutting the atrial septal tissue around the perforation. Specifically, the supporting piece 4301 is bent and radiated along the axis line direction and the direction deviating from the axis line. The supporting piece radiating to the distal end forms a flange-like structure. When entering the heart tissue, the myocardium is scratched to improve safety; the support sheet radiating to the proximal end forms a spherical structure or a similar spherical structure, and the proximal ends converge to form a connector 431. The connector 431 connects with the outer tube 30 and is sleeved outside the catheter body 20 . After the operation is over, the outer tube 30 is withdrawn to recover the positioning stent 43 to the delivery sheath, and finally the improved atrial septostomy device 100c is completely withdrawn from the body.

In other embodiments, as shown in FIG. 10, the structure of the improved atrial septostomy device 100d is similar to that of the fourth embodiment, except that the positioning bracket 43a is woven from wire, and the positioning bracket 43a can be independent When the cryo-balloon 42 is released and retracted and contracted, the atrial septal shunt system is fully released. The positioning bracket 43a includes a concave waist 430a with a curved surface and a flat flange-like distal end extending from the waist 430a to the distal end. The positioning member 432c is a proximal positioning member 432d extending from the waist 430a to the proximal end. Specifically, the distal end positioning member 432c includes a conical or circular plane radially extending from the distal edge of the waist 430a toward the distal end, and a curved frame whose outer edge of the plane is curved toward the distal end. , The curved frame is smoothly curved toward the distal end to avoid damaging the atrial tissue.

The proximal positioning member 432d includes a spherical structure or a similar spherical structure formed by radially outwardly extending from the proximal edge of the waist 430a toward the proximal end. The high-density gap woven net forms a conical thrombus catching cage, which can catch and recover thrombus hanging on the proximal positioning member 432d. The cone 431a is used to connect the outer tube 30 and sleeve it outside the catheter body. After the operation is over, the outer tube 30 is withdrawn to recover the positioning stent 43a to the delivery sheath, and finally the improved atrial septostomy device is completely withdrawn from the body.

It should be noted that, without departing from the principle of the embodiments of the present application, the specific technical solutions in the above embodiments may be mutually applicable, and will not be repeated here.

The above is the implementation of the embodiments of the present application. It should be pointed out that for those of ordinary skill in the art, without departing from the principle of the embodiments of the present application, several improvements and modifications can be made, and these improvements and modifications are also Treated as the scope of protection of this application.

Claims (17)

An improved atrial septostomy device used to ablate surrounding tissues perforated on the atrial septum, characterized in that the improved atrial septostomy device includes a catheter body and a stoma arranged at the distal end of the catheter body The main body, the ostomy main body includes a freezing balloon, the outer wall of the freezing balloon is provided with a stoma part along the circumferential direction, and the inner cavity of the freezing balloon is filled with refrigerant so that the stoma part contacts the perforated The surrounding tissues cause irreversible damage to prevent the perforation from healing or shrinking. The improved atrial septostomy device according to claim 1, wherein the proximal end of the catheter body is provided with a perfusion port, the catheter body is provided with a plurality of injection ports in the cryo-balloon, and the catheter body The injection port is provided with a fluid infusion channel connecting the injection port and a plurality of injection ports. The refrigerant is injected from the injection port to the inner cavity of the freezing balloon through the injection port and the injection port to fill the cavity. The freezing balloon supports the stoma part on the surrounding tissue of the perforation. The improved atrial septostomy device according to claim 2, wherein after the cryo-balloon is filled, the cryo-balloon is cylindrical, and the stoma is formed by the cryo-balloon along the axial direction. The outer wall near the center position. The improved atrial septostomy device according to claim 2, wherein a recovery port is opened at the proximal end of the catheter main body in the cryo-balloon, and the recovery port is connected to the inner part of the cryo-balloon. In the cavity, the conduit main body is provided with a receiving channel communicating with the recovery port along the axial direction, and the receiving channel is used for recovering refrigerant. The improved atrial septostomy device according to claim 2, wherein the cryo-balloon is made of non-compliant material, and after the inner cavity of the cryo-balloon is filled, the diameter of the stoma is The radial dimension is equal to or greater than the radial dimension of the stoma; or the cryo-balloon is made of a compliant material, and the radial dimension of the stoma of the cryo-balloon can be adjusted by the amount of refrigerant input to Form stomas of different radial sizes. The improved atrial septostomy device according to claim 2, wherein the proximal edge and the distal edge of the cryo-balloon are sealingly connected to the outer wall of the catheter body, and the inner surface of the cryo-balloon An inner cavity of the freezing balloon is formed between the outer peripheral surface of the catheter body, and the refrigerant is filled into the inner cavity. The improved atrial septostomy device according to claim 2, wherein the proximal end and/or the distal end of the stoma portion of the cryo-balloon are provided with positioning elements, and the positioning elements are used for positioning to the chamber. The proximal and/or distal surface of the perforation in the interval. The improved atrial septostomy device according to claim 7, wherein the positioning member is a plurality of convex points and/or ridges protruding from the outer wall of the stoma, and a plurality of the convex points and/or The convex strip forms a circle along the circumferential direction of the stoma. The improved atrial septostomy device according to claim 7, wherein the positioning member is at least one annular convex strip surrounding the outer wall of the stoma. The improved atrial septostomy device according to claim 7, wherein the positioning member is a positioning bracket provided on the outer periphery of the stoma. The improved atrial septostomy device according to claim 1, wherein the cryo-balloon comprises an inner balloon and an outer balloon nested with each other, and the stoma is the outer wall of the outer balloon The waist in the middle part of the axial direction is indented in the circumferential direction. When the stoma of the cryo-balloon straddles the atrial septal tissue and is filled, the outer balloon is supported on the atrial septal tissue to make the stoma The radial dimension is equal to or greater than the radial dimension of the stoma. The improved atrial septostomy device according to claim 11, wherein the outer balloon is provided with positioning parts at the proximal end and the distal end of the stoma part, and the radial dimension of the positioning part is It is larger than the radial dimension of the stoma. The improved atrial septostomy device according to claim 11, wherein the catheter body is provided with a plurality of jet ports respectively communicating with the inner cavity of the outer balloon and the inner cavity of the inner balloon, and The proximal end of the catheter body is provided with an infusion port, and the catheter body is provided with an infusion channel that communicates the infusion port and the injection port, and the refrigerant simultaneously fills the outer balloon through the infusion port and the infusion channel And the inner balloon, so that the stoma part is supported on the surrounding tissue of the perforation. The improved atrial septostomy device according to claim 11, wherein the catheter body is provided with a plurality of jet ports respectively communicating with the inner cavity of the outer balloon and the inner cavity of the inner balloon, and The proximal end of the catheter body is provided with two perfusion ports, and two spaced infusion channels are provided in the catheter body along the axial direction to communicate with the injection ports of the inner balloon and the outer balloon, and the refrigerant passes through the The perfusion port and the drug infusion channel respectively independently fill the outer balloon and the inner balloon, so that the stoma is supported on the surrounding tissue of the perforation. The improved atrial septostomy device according to claim 11, wherein the catheter body is provided with a plurality of jet ports communicating with the inner cavity of the outer balloon, and the proximal end of the catheter body is provided with an infusion port, The catheter body is provided with an infusion channel connecting the perfusion port and the injection port, and refrigerant fills the inner cavity between the outer balloon and the inner balloon through the perfusion port and the infusion channel , So that the stoma is supported on the surrounding tissue of the perforation. The improved atrial septostomy device according to claim 11, wherein the inner balloon is cylindrical after being filled, the outer balloon is dumbbell-shaped after being filled, and the outer wall of the middle part of the inner balloon is against Connected to the stoma portion of the outer balloon, the outer balloon is made of non-compliant or semi-compliant material, and the inner balloon is made of compliant material. By changing the radial direction of the inner balloon Size to adjust the radial size of the stoma. The improved atrial septostomy device according to claim 11, wherein the outer balloon is made of a compliant material or a semi-compliant material, by increasing or reducing the filling into the inner cavity of the outer balloon Refrigerant to change the radial dimension of the stoma.

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