JP5282185B2 - Ventricular affected part prosthesis and ventricular affected part prosthetic treatment set - Google Patents

Description

The present invention relates to a ventricular diseased part prosthesis, a ventricular diseased part prosthesis treatment set, and an indwelling method thereof capable of treating a hole opened in a ventricular diseased part without causing cardiac arrest and incising the myocardium. is there.
Here, the hole opened in the affected part of the ventricle typically includes a ventricular septum perforation or a ruptured hole due to a ventricular free wall rupture.
Ventricular septal perforation is a disease in which a necrotic ventricular septum is perforated and a short circuit between the left and right ventricles occurs. This is a serious disease that requires early ventricular septal perforation.
Ventricular free wall rupture is one of the serious complications of acute myocardial infarction, along with ventricular septal perforation, and means that the ventricular wall of the left or right ventricle is ruptured. Myocardial infarction occurs mainly due to myocardial infarction, and the necrotic part cracks and eventually ruptures. If a ventricular free wall rupture occurs, blood may leak from the ruptured area, causing blood pressure to drop rapidly and death.
The ventricular diseased part prosthesis of the present invention is a prosthesis for closing a rupture hole due to ventricular septal perforation or ventricular free wall rupture.

  In the prior art, as a surgical procedure for Ventricular septal perforation or Ventricular septal rupture after acute myocardial infarction, after the necrotic myocardium is removed, the resection site is reconstructed with a patch. The Dagett method has been widely implemented as a basic technique (see Non-Patent Documents 1 and 2). Recently, left ventricular plastic surgery (Endocardial patch repair with infarct exclusion) using a pericardial patch is often performed as a so-called Komeda-David method that does not remove necrotic myocardium (Non-patent Document 3).

In any of the conventional methods of the conventional method of the Dagett method and the Komeda-David method, a mediastinal thoracotomy is performed through a median sternotomy, blood is extracorporeally circulated using an artificial cardiopulmonary apparatus, and cardiac arrest is involved. . An incision is made in the ventricular wall in the vertical direction, and the pericardial patch is continuously sutured from the part considered to be healthy on the posterior septal wall side while confirming the anterior papillary muscle and the posterior papillary muscle.
Conventionally, the Dagett method is to reconstruct the excision site with a patch after excising the necrotic myocardium.
In contrast, the Komeda-David method does not remove necrotic myocardium and preserves the right ventricular function by preserving the right ventricular myocardium, and preserves the left ventricular volume by preserving the left ventricular myocardium. It is supposed to be drunk.

Dagett et al., Ann Surg, 196: 269, 1982. Dagett et al., J Thorac Cardiovas Surg 84, 306, 1982. Komeda et al., Circulation 82 (Supple IV) 242, 1990.

  The above-described conventional technique using the Dagett method involves excision of necrotic myocardium, and there is a problem that normal myocardial tissue that should not be excised may be accidentally excised. In addition, since the left ventricular incision is exposed to the high-pressure left heart system, there is a problem that caution is required in controlling bleeding.

  In contrast, the Komeda-David method does not remove necrotic myocardium, so that the right ventricular myocardium is preserved and the right ventricular function is maintained, and since the myocardium is not excised, improvement of wall motion by functional recovery can be expected. Also, since the left ventricular myocardium is not excised, there is an advantage that the volume of the left ventricle is maintained. In addition, with regard to bleeding that has been regarded as a problem of the Dagett method, the Komeda-David method has a merit that the patch hits the inside of the left ventricular incision portion and becomes a low-pressure right heart system, so that bleeding can be reduced.

However, the Komeda-David method also has a problem that the degree of invasiveness to the patient is high because it involves extracorporeal blood circulation and myocardial incision using an anxiety stop device. The incision of the myocardium is said to extend about 2/3 of the left ventricular long axis. This high degree of invasiveness is still a big problem considering the patient load regardless of whether the method is the Dagett method or the Komeda-David method. It is said that mortality after surgery tends to be high.
Moreover, since the structure of the necrotic myocardial tissue is unstable compared to the normal tissue in both the Dagett method and the Komeda-David method, the operation of sewing the pericardial patch is very skillful. There was a problem that it was a difficult procedure.

In view of the above problems, the present invention provides a ventricle capable of prosthetic ventricular septal perforation and ventricular free wall rupture hole by a minimally invasive method without extracorporeal blood circulation and myocardial incision using an anxiety stop device. It aims at providing an affected part prosthesis.
The present invention also provides a ventricular disease prosthesis treatment set in which the ventricular disease prosthesis is placed so as to close the ventricular septum perforation or free ventricular rupture hole of the heart by a minimally invasive and simple procedure. The purpose is to provide.

In order to achieve the above object, a ventricular diseased prosthesis of the present invention is
A substantially saddle-shaped ventricular diseased prosthesis that fits within the heart chamber,
A hook-shaped member formed of a spring material capable of contraction / relaxation, and capable of contraction / relaxation in at least the inner diameter of the heel according to contraction / relaxation of the heart ;
A cloth-like member that covers at least a part of the outer wall surface of the spring material and can be contracted / relaxed by the contraction / relaxation of the spring material;
A plurality of fixing members for fixing the saddle-shaped member in the heart chamber of the heart ;
A plurality of small holes for insertion of the fixing member in the bowl-shaped member ,
At least one of the fixing members is a thread-like member, one end thereof is fixed to the outer wall surface of the hook-shaped member, and the other end is inserted along one outer hole along the outer wall surface of the hook-shaped member to insert the small hole. It is led into the inside of the saddle-shaped member, and further led out from the other small hole to the outside and fixed to the ventricle of the heart, and the posture of the saddle-shaped member is adjusted by fixing the plurality of fixing members, and the heart It was placed in the ventricle, a ventricular diseased prosthesis allowed to placement so as to close the affected part of the ventricle of the heart.
With the above configuration, the cloth-like member can more reliably block an affected part such as a ventricular septum perforation or a ventricular free wall rupture hole. The ventricular diseased part prosthesis of the present invention is not an operation method of closing a ventricular septum perforation or a ventricular free wall rupture hole by stitching a conventional pericardial patch or the like to the affected part, but on the outer wall surface of the bowl-shaped member Thus, the affected part such as a ventricular septal perforation or a ventricular free wall rupture hole can be placed and fixed so as to close the affected part, and the affected part can be prosthetic by a minimally invasive method. In addition, the ventricular diseased part prosthesis of the present invention can be placed in either the right ventricle or the left ventricle according to the disease. Free wall destruction may be in the left ventricle or in the right ventricle, but ventricular septal perforation is often mainly in the left ventricle.
The surgical technique using the ventricular disease prosthesis of the present invention is a minimally invasive prosthetic technique of a new concept that has never been known before, and there is no example that discloses such a prosthesis.

Note that at least one of the fixing members is preferably a thread-like member.
A fixing member for fixing the ventricular diseased prosthesis Other mechanical mechanical parts such as an anchor or hook, can be placed in the ventricle by using as a fixing member small threadlike members load to the human body.

Next, the ventricular diseased part prosthetic treatment set of the present invention,
The ventricular diseased part prosthesis of the present invention as described above and a tubular auxiliary device that secures a penetration path into the ventricle of the heart,
The rod-shaped member can be contracted in the rod inner diameter direction to a size that passes through the lumen of the tubular auxiliary tool,
Inserting or penetrating the tubular auxiliary device into the heart such that one end of the opening is outside the heart and the other end is inside the heart chamber;
The hook-shaped member is allowed to pass through one end of the opening of the tubular assisting tool while being contracted in the inner diameter direction of the tubular assisting tool so that it can be passed through the lumen of the tubular assisting tool. It guides into the ventricle, and after passing through the other end of the opening, restores the saddle-like member into a generally saddle-like shape that fits in the heart chamber of the heart, and places it in the heart chamber of the heart.

In addition, it is preferable that the tubular auxiliary device includes a backflow prevention valve, and blood does not flow back from the heart chamber of the heart even if it penetrates into the heart chamber of the heart.
With the above-described configuration, the ventricular diseased part prosthesis of the present invention can be placed so as to block the ventricular septal perforation of the heart with a minimally invasive and simple procedure while using a tubular auxiliary tool.

Next, the first indwelling method of the ventricular diseased part prosthesis of the present invention,
The ventricular diseased part prosthesis of the present invention described above is a method in which the ventricular member is placed in the heart chamber so as to cover the ventricular wall of the heart with the outer wall surface of the bowl-shaped member and block the hole opened in the ventricle of the heart. And
Inserting or penetrating the tubular auxiliary device into the heart such that one end of the opening is outside the heart and the other end of the opening is in the ventricle ;
The hook-shaped member is allowed to pass through one end of the opening of the tubular assisting tool while being contracted in the inner diameter direction of the tubular assisting tool so that it can be passed through the lumen of the tubular assisting tool. It is a method according to a procedure in which the rod-like member is guided into the ventricle and passes through the other end of the opening to restore the saddle-like member into a substantially saddle-like shape that fits in the heart chamber of the heart and is placed in the heart chamber of the heart.

  Here, the procedure of inserting the other end of the opening of the tubular auxiliary device into the heart chamber of the heart is to pass the guide wire from the outer wall of the heart apex portion into the heart chamber, and ascend the tip of the guide wire. A step of leading out from a port provided in the aorta, and a leading end of the guide wire is inserted from the other end of the opening of the tubular auxiliary device, and the other end of the opening of the tubular auxiliary device is aligned with the guide wire It is preferable that the procedure is such that it is guided to the inside of the heart via the head so as to be positioned near the apex.

In addition, the procedure for guiding the saddle-like member into the heart chamber of the heart includes connecting the distal end of the guide wire to the fixture, and pulling the guide wire from the apex side so that the distal end of the guide wire It is preferable that the procedure is to pull the tied fixture and the hook-like member to which the fixture is attached to guide it into the ventricle.
According to the above procedure, the ventricular diseased part prosthesis of the present invention can be placed in the ventricle by a minimally invasive method.

Next, the second indwelling method of the ventricular diseased part prosthesis of the present invention is:
The ventricular diseased part prosthesis of the present invention described above is a method in which the ventricular member is placed in the heart chamber so as to cover the ventricular wall of the heart with the outer wall surface of the bowl-shaped member and block the hole opened in the ventricle of the heart. And
The tubular member is passed from one end of the opening to the other end of the tubular assisting device while contracting in the inner diameter direction of the tubular assisting device to a size that can pass through the lumen of the tubular assisting device. Put it in
Inserting or penetrating the tubular auxiliary device into the heart such that one end of the opening is outside the heart and the other end of the opening is in the ventricle ;
The saddle-shaped member positioned at one end of the tubular assisting device is introduced into the ventricle from the tubular assisting device, and the saddle-shaped member is restored to a substantially saddle shape that fits in the ventricle of the heart , This is a method according to a procedure of placing the inside of the heart of the heart using a fixing member .

In the second indwelling method of the ventricular diseased part prosthesis, the procedure for inserting the tubular auxiliary device including the saddle-shaped member into the left ventricle of the heart is a guide wire from the outer wall of the left ventricular apex of the heart. Through the inside of the left ventricle, the procedure of leading the tip of the guide wire to the outside from the port provided in the ascending aorta, the procedure of connecting the fixing member attached to the saddle member 10 and the guide wire, By pulling out the guide wire from the left ventricular apex side, the left side is pulled by pulling the fixing member to which the guide wire is connected via the port and the hook-like member to which the fixing device is attached. It is preferable that the procedure leads to the ventricle.
Also by the above procedure, the ventricular diseased part prosthesis of the present invention can be placed in the ventricle by a minimally invasive method.

  The prosthetic device for closing the ventricular septal perforation and ventricular free wall rupture hole according to the present invention and the tubular auxiliary device for introducing the ventricular septum into the affected area have a lower invasiveness and a simple procedure compared to conventional surgical methods. In addition, a surgical method showing a high survival rate after surgery can be provided.

  Hereinafter, a ventricular diseased part prosthesis and a prosthesis set of the present invention will be described in detail based on preferred embodiments shown in the accompanying drawings. The present invention is not limited to these examples.

A configuration of a ventricular diseased part prosthesis placed in the ventricle as an example of a ventricular diseased part prosthesis according to Example 1 will be specifically described with reference to the accompanying drawings.
A ventricular diseased part prosthesis according to a first embodiment of the present invention includes a substantially saddle-like saddle-like member that fits in the heart chamber of the heart, and a fixing member that fixes the saddle-like member in the heart chamber of the heart. In the fixed state, the ventricle wall of the heart is covered with the outer wall surface of the saddle-like member, and the affected part such as a ventricular septum perforation or a ventricular free wall rupture hole is indwelled.
Ventricular septal perforation is a disease in which a necrotic ventricular septum is perforated and a short circuit between the left and right ventricles occurs. Ventricular free wall rupture is one of the serious complications of acute myocardial infarction, along with ventricular septal perforation, and means that the ventricular wall of the left or right ventricle is ruptured. The ventricular diseased part prosthesis of the present invention is a prosthesis for closing a rupture hole due to ventricular septal perforation or ventricular free wall rupture.
Hereinafter, ventricular septal perforation will be described as an example of a ventricular diseased part. Note that the present invention can be similarly applied to a ventricular free wall rupture hole.

  FIG. 1 is a diagram illustrating a configuration example of a ventricular diseased part prosthesis according to Example 1 of the present invention. FIG. 1A shows a side view, and FIG. 1B shows a front view.

As shown in FIG. 1, the ventricular diseased part prosthesis of the present invention includes a hook-shaped member 10 and a fixing member 20 attached to the hook-shaped member 10.
In the following, in FIG. 1, the left side of the hook-shaped member 10, that is, the bottom side where the hook is closed is referred to as “bottom”, and the right side of the hook-shaped member 10, that is, the open edge side of the hook.
Although the diameter of the upper part of the bowl-shaped member 10 is not limited, since it is a prosthetic device that fits in the patient's ventricle, for example, about 50 to 90 mm is preferable. Further, although the length from the top to the bottom is not limited, it is a prosthetic device that fits in the patient's ventricle, and is preferably about 30 to 70 mm, for example.

  FIG. 2 is a diagram illustrating a configuration example of the bowl-shaped member 10a that is not symmetrical. 2A is a side view and FIG. 2B is a front view. As shown in FIG. 2, the shape of the bowl-shaped member is not necessarily symmetrical. That is, the distance from the bottom portion to the upper edge does not need to be particularly uniform, and may be determined according to the situation around the indwelling position of the bowl-shaped member 10. Depending on the positional relationship between the ventricular septal perforation and the papillary muscle around the indwelling position when the ventricular septal perforation is prosthetic, the saddle-shaped member 10a may come into contact with the papillary muscle and placement may be difficult. sell. In such a case, if the distance between the sides located in the vicinity of the papillary muscle is shortened as the shape of the hook-shaped member 10a, the contact between the hook-shaped member 10a and the papillary muscle can be avoided.

  The distance from the bottom of the bowl-shaped member 10 to the upper edge may be a length that can block the ventricular septal perforation. Ventricular septal perforation can occur anywhere in the ventricular septum. Further, the saddle-shaped member 10 is placed so that the bottom thereof is positioned substantially at the apex of the heart. Therefore, if at least the longest distance from the bottom to the upper edge of the bowl-shaped member 10 is equal to the distance from the apex to the upper end of the ventricular septum, the ventricular septal perforation can be blocked in all cases. The distance from the apex to the upper end of the ventricular septum is approximately 40 mm to 60 mm for adults. It should be noted that a plurality of types of ventricular diseased prosthetic devices according to the present invention having different longest distances from the bottom to the upper edge of the bowl-shaped member 10 are prepared in advance, and these are determined depending on the position of the ventricular septal perforation. It may be properly selected and used properly.

  Although the raw material of the bowl-shaped member 10 is not limited, For example, what is generally used for an artificial blood vessel is preferable. For example, various resin materials such as polyethylene terephthalate (PET, dacron, tetron, etc.), polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE) and polyurethane, which are a kind of saturated polyester, And combinations of two or more of these.

  The structure of the hook-shaped member 10 may be any structure that can form a hook-shaped shape, but for example, a structure generally used for an artificial blood vessel is suitable. For example, a fibrous material knitted or plain woven, or a porous structure can be mentioned.

  The fixing member 20 only needs to be able to fix the flange-shaped member 10 to the ventricular wall, and examples thereof include a thread-like member. The number of thread members is not particularly limited, and may be, for example, about 1 to 4. Although the raw material of a thread-like member is not specifically limited, For example, what is generally used for surgery is suitable. For example, nylon etc. are mentioned. When a thread-like member is used, fixing of the hook-like member 10 to the ventricular wall is performed by tying the thread-like member to the ventricular wall using a means that is usually used during surgery. If there are a plurality of thread-like fixing members 20 attached to different positions of the hook-shaped member, the shape of the hook-shaped member 10 can be appropriately adjusted by appropriately pulling the thread-shaped members respectively, and the placement in the ventricle can be further improved. You can be sure. If there are four thread-like members arranged at four points that are uniformly spaced on the horizontal cross-section of the hook-shaped member, the shape of the hook-shaped member can be adjusted in each of the four horizontal directions as necessary.

The fixing member 20 may be disposed at any part of the hook-shaped member 10, but in the example of FIG. 1, four thread-shaped fixing members 20 are disposed at the bottom of the hook-shaped member 10. . Four thread-like fixing members 20 extending outward from the bottom of the saddle-shaped member 10 are tied to the ventricular wall in a state in which the saddle-shaped member 10 is placed in the ventricle and fixes the saddle-shaped member 10. .
In this configuration example, the four thread-like fixing members 20 pass through two openings provided in the vicinity of the bottom of the hook-shaped member 10 twice, and extend along the outer surface of the hook-shaped member. It extends to the edge slightly below. This is a device for appropriately adjusting the shape of the hook-like member 10 by pulling the thread-like fixing members 20 appropriately.

  In addition, in the bowl-shaped member 10, the small hole 14 which can penetrate the fixing member 20 may be provided in the bottom part. When such a small hole 14 is provided, it is easy to control the posture of the bowl-shaped member 10 by the fixing member 20, and the fixation to the ventricular wall becomes easier.

  FIG. 3 is a diagram illustrating a configuration example in which a small hole 14 into which the fixing member 20 can be inserted is provided at the bottom of the bowl-shaped member 10 illustrated in FIG. 1. In the configuration example of FIG. 3, the small holes 14 are an example in which one small hole provided at the bottom and four small holes arranged in a cross shape around the small hole 14 are provided. One end of the fixing member 20 which is a thread-like member is fixed to the outer wall surface of the hook-like member 10, and the other end is guided to the bottom surface along the outer wall of the hook-like member 10, and the small hole 14 is inserted therethrough once. It is introduced into the inside of the shaped member 10 and further led out to the outside through the small hole 14 at the bottom. Since the thread-like member controls and fixes the posture of the hook-like member 10 through the outer wall surface of the hook-like member 10 and the two small holes 14, the hook-like member 10 can be reliably fixed. In the example of FIG. 3, since it is fixed from four directions with four thread-like members, it can be more reliably fixed.

  FIG. 4 is a diagram illustrating a configuration example in which a small hole through which the fixing member 20 can be inserted is provided at the bottom of the bowl-shaped member 10a that is not symmetrical in the left-right direction illustrated in FIG. Similar to FIG. 3, the hook-shaped member 10 a can be reliably fixed because the thread-shaped member controls and fixes the posture of the hook-shaped member 10 a through the outer wall surface of the hook-shaped member 10 a and the two small holes 14. .

Next, the contraction / extension movement of the bowl-shaped member 10 will be described.
The saddle-shaped member 10 is capable of contracting / extending in the radial inner diameter direction and further in the radial axis direction following the contraction / extension of the heartbeat of the heart.
If the saddle-shaped member 10 does not contract or expand at all, after the heartbeat is sufficiently demodulated after the surgical procedure, the ventricle contracts and expands, but the indwelling ventricular diseased part prosthesis is not deformed. It does not harmonize with contraction / extension and may affect the movement of the heart.
On the other hand, if the saddle-like member 10 is contracted / expanded following the contraction / extension of the heart, after the heartbeat is sufficiently demodulated after the operation, the indwelling ventricular diseased prosthesis device is driven by the movement of the heart. Because it is deformed, it does not affect the movement of the heart in life after discharge.

Next, a device for placing the ventricular diseased part prosthesis of the present invention in the ventricle will be described.
As an indwelling method of the ventricular diseased part prosthesis of the present invention in the ventricle, for example, it is possible to adopt an indwelling method with a high degree of invasiveness involving extracorporeal blood circulation and myocardial incision using an anxiety stop device. However, one of the objects of the present invention is to provide a ventricular diseased part prosthesis capable of prosthetic ventricular septal perforation by a minimally invasive method without extracorporeal blood circulation and myocardial incision using an anxiety stop device. There is to do. Accordingly, the inventor of the present application has newly developed a device for placing a ventricular diseased part prosthesis so that the ventricular septal perforation of the heart is blocked by a minimally invasive and simple technique. This ingenuity is novel and unprecedented and achieves placement with minimally invasive and simple techniques.

  The device for indwelling the ventricular diseased part prosthesis of the present invention is a device using a structural device of the bowl-shaped member 10 and a jig called a tubular auxiliary device 30.

First, as a device for the saddle-like member structure, the saddle-like member 10 of the present invention can be contracted to a size that can pass through the lumen of the tubular auxiliary tool 30 in the radial inner diameter direction.
FIG. 5A is a diagram illustrating a state in which the tubular auxiliary tool 30 and the hook-shaped member 10 contract and expand in the inner diameter direction to a size that can pass through the lumen of the tubular auxiliary tool 30. FIG. 5 (b) is a view showing a state where the hook-shaped member 10 contracts and passes through the lumen of the tubular auxiliary tool 30.
The size at which the hook-shaped member 10 of the present invention contracts corresponds to the lumen of the tubular auxiliary tool 30.
The tubular auxiliary tool 30 is inserted into the ventricle and forms a passage connecting the outside and the inside of the ventricular wall.
The outer diameter of the tubular auxiliary tool 30 is preferably about 3 to 20 mm in order to pass through an insertion hole made in the ventricular wall without greatly damaging the myocardium. The diameter of the lumen of the tubular auxiliary tool 30 is further reduced by the thickness of the tube wall. Therefore, the bowl-shaped member 10 is significantly contracted as compared with the original size of about 30 to 70 mm as shown in FIG.

  The tubular auxiliary tool 30 has a structural strength that allows the saddle-shaped member 10 to be inserted therethrough, and may be a smooth tube-shaped member that does not damage the saddle-shaped member 10 or the myocardium. For example, various resin materials such as polyethylene terephthalate (PET, Dacron, Tetron, etc.), polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE) and polyurethane used in catheters, Are preferably the same as the flexible tube, such as a combination of two or more of these.

  Since the tubular auxiliary tool 30 forms a passage connecting the outside and the inside of the ventricular wall, it is preferable to have a structure including a backflow prevention valve. The function of the backflow prevention valve prevents blood from flowing back from the heart chamber.

Next, a procedure for indwelling the ventricular diseased part prosthesis according to the present invention will be described in detail.
The indwelling procedure of the ventricular diseased part prosthesis according to the present invention includes inserting the tubular auxiliary tool 30 into the heart 1 so that one end of the opening is outside the heart 1 and the other end of the opening is the ventricle 3. The member 10 is allowed to pass through one end of the opening of the tubular assisting device 30 while being contracted in the inner diameter direction of the tubular assisting device 30 to a size that can pass through the lumen of the tubular assisting device 30, thereby allowing the saddle-shaped member 10 to pass through the inner chamber 3. Then, after passing through the other end of the opening, the rod-like member 10 is restored to a substantially rod-like shape that can be accommodated in the heart chamber 3 and is placed in the heart chamber 3.
In the present invention, the indwelling method is further devised to realize a minimally invasive indwelling method.

The above procedure will be described in detail step by step with reference to the drawings.
FIGS. 6-15 is a figure for demonstrating the indwelling procedure to the left ventricle of the ventricle affected part prosthesis based on this invention, respectively. For ease of explanation, the various elements shown in the figures are not drawn to scale. A ventricular septum perforation 2 is schematically shown in the ventricular septum of the heart 1. As necessary, each procedure is based on the position of each device or each device and each organ by means of using the X-ray fluoroscopy device alone or in combination with the X-ray fluoroscopy device and the echocardiogram (cardiac ultrasound) device. Check the relationship visually.

(Procedure 1)
A port 60 is installed in the artery wall 5 of the ascending aorta (see FIG. 6). By this procedure, a passage from the artery side of the ascending aorta to the heart 1 is secured.

(Procedure 2)
A sheath 40 with a backflow prevention valve is inserted through the left ventricular outer wall 4 at the apex of the left ventricle and inserted into the left ventricle 3. By this procedure, a passage from the bottom side of the left ventricle 4 to the left ventricle 3 is secured (see FIG. 7).

(Procedure 3)
A guide wire 50 is inserted into the left ventricular chamber 3 from the outer wall 4 of the left ventricular apex of the heart through the opening of the sheath 40 with a check valve, and the distal end of the guide wire 50 is near the port 60 provided in the ascending aorta. (See FIG. 8).

(Procedure 4)
The basket catheter 70 is inserted into the ascending aorta from the opening of the port 60, the vicinity of the distal end of the guide wire 50 is captured by the basket catheter 70, and the distal end of the guide wire 50 is pulled out of the artery through the port 60 (FIG. 9, (See FIG. 10).
By the procedure 3 and the procedure 4, the guide wire 50 can be passed from the left ventricular bottom surface to the ascending aorta.
In the above procedure 4, the guide wire 50 is pulled out of the artery using the basket catheter 70. However, the method is not limited to the method using the basket catheter 70, and any other method can be used to pull the guide wire 50 out of the artery. Can be adopted. However, it is preferable that the method is as minimally invasive as possible.

(Procedure 5)
Next, the tubular auxiliary device 30 with a check valve is passed from the ascending aorta into the left ventricle in the following procedure (see FIG. 11).
The distal end of the guide wire 50 is inserted into the other end of the opening of the tubular assisting device 30, the tubular assisting device 30 is advanced along the guide wire 50, and is passed from the ascending aorta to the inside of the heart via the port 60. Guide to the left ventricular chamber 3. The tubular auxiliary tool 30 is advanced until it comes into contact with the inner wall of the left ventricle where the sheath 40 with the backflow prevention valve is perforated (see FIG. 12).

(Procedure 6)
Next, preparation for insertion of the bowl-shaped member 10 is performed. First, the tip of the guide wire 50 is tied to the fixing member 20 attached to the hook-shaped member 10.
In this example, the length of the fixing member 20 is set to be longer than the opening of the sheath 40 with the backflow prevention valve serving as the outlet from the opening of the port 60 serving as the inlet (see FIG. 13).

(Procedure 7)
Next, the fixing member 20 fixed to the distal end of the guide wire 50 is pulled by pulling the guide wire 50 from the outer wall 4 side of the left ventricular apex.
The guide wire 50 is pulled until the fixing member 20 passes through the tubular auxiliary device 30 from the port 60 and comes out of the left ventricle through the sheath 40 with the backflow prevention valve.
Here, when the length of the fixing member 20 is short, the hook-like member 10 is driven and pulled by the fixing member 20 in the pulling stage of the guide wire 50 in the procedure 7. In this case, the hook-shaped member 10 is pulled through the guide wire 50 and the fixing member 20. Therefore, the length of the fixing member 20 is sufficiently long to extend from the opening of the port 60 to the opening of the sheath 40 with the backflow prevention valve (see FIG. 13).

(Procedure 8)
Next, the guide wire 50 and the thread-like member 12 are unfixed. Further, the sheath 40 with the backflow prevention valve is removed from the outer wall of the left ventricle (see FIG. 14).

(Procedure 9)
While pulling the fixing member 20 from the left ventricular outer wall 4 side, the base member 10 is pulled inward from the opening of the tubular auxiliary tool 30 while the bottom member is directed toward the traveling direction side while the flange-shaped member 10 is contracted in the inner diameter direction. In addition, when the hook-shaped member 10 is pushed in from the upper direction with the rod 13 or the like, the hook-shaped member 10 can easily move inside the tubular auxiliary tool 30.
The tubular auxiliary tool 30 is moved to a position where the bottom reaches the left ventricular wall (see FIG. 14).

(Procedure 10)
The tubular auxiliary tool 30 is pulled out in a state where the fixing member 20 is pulled from the outside of the left ventricle and the bottom of the bowl-shaped member 10 is appropriately fixed to the left ventricular wall. Here, although the tubular auxiliary tool 30 is removed, the hook-shaped member 10 is pulled by the fixing member 20, so that only the hook-shaped member 10 remains in the left ventricle 3. When the hook-shaped member 10 is accommodated in the tubular auxiliary tool 30, the diameter of the hook-shaped member 10 is contracted. However, since the tubular auxiliary tool 30 is removed, the hook-shaped member 10 expands to the original diameter. Return (see FIG. 15).

(Procedure 11)
Finally, the saddle member 10 is positioned and placed so that the ventricular septal perforation is appropriately blocked by the saddle member 10. The fixing member 20 is appropriately pulled from the outside of the left ventricle and applied with tension to be fixed to the left ventricular wall, and adjusted so that the bottom of the bowl-shaped member 10 is in close contact with the left ventricular wall (see FIG. 15).
When positioning the saddle-shaped member 10, it can be adjusted so that the saddle-shaped member 10 is closely attached to the myocardium as necessary. The fixation can be adjusted by using the fixing member 20b which is a mechanical component. For example, the hook is inserted into the myocardium from the outside of the myocardium, the tip of the hook is hooked on the outer surface of the hook-like member 10, and the hook is pulled. Adjust to ensure close contact with ventricular septal perforation.
In FIG. 15, as an example of attaching the fixing member, the fixing member of the thread-like member is shown as the fixing member 20a, and the fixing member such as an anchor or hook which is another mechanical mechanism component is shown as the fixing member 20b.

(Procedure 12)
The port 60 is removed from the living body, and a hole in the aortic wall opened by piercing the port 60 is sutured (see FIG. 15).

  Instead of the procedure from the procedure 5 to the procedure 9, the procedure from the next procedure 5-2 to the procedure 9-2 can be used. If the procedure from the procedure 5 to the procedure 9 is performed, the tubular assisting device 30 is moved from one end to the other end of the tubular assisting device 30 while contracting the saddle-shaped member 10 with the tubular assisting device 30 introduced from the ascending aorta to the ventricle. However, if it is the procedure from the following procedure 5-2 to the procedure 9-2, the scissors-like member 10 can be moved from one end of the tubular auxiliary tool 30 to the other end first by the practitioner. Therefore, it is advantageous when it is difficult to move the bowl-shaped member 10 within the tubular auxiliary tool 30.

(Procedure 5-2)
Preparation for insertion of the bowl-shaped member 10 is performed. First, at the practitioner's hand, the saddle-like member 10 is contracted in the inner diameter direction, and the bottom portion is positioned in the vicinity of one end of the opening of the tubular assisting device 30 so that the inside of the tubular assisting device 30 with the backflow prevention valve is located. Insert (see FIG. 16).

(Procedure 6-2)
Next, preparation for introducing the fixing member 20 into the left ventricular apex is performed. The distal end of the guide wire 50 is inserted into the one end of the opening of the tubular auxiliary tool 30, and the guide wire is reached until the other end of the tubular auxiliary tool 30 is reached through a small hole provided in the bottom of the bowl-shaped member 10. Pass 50. When the threading is finished, the guide wire 50 is fixed by connecting the portion located near the bottom of the hook-shaped member 10 and the fixing member 20 attached to the hook-shaped member 10 (see FIG. 17).
In this example, the length of the fixing member 20 is long, and both are longer than the opening of the port 60 and the opening of the sheath 40 with the backflow prevention valve.

(Procedure 7-2)
Next, the fixing member 20 fixed to the guide wire 50 is pulled by pulling the guide wire 50 from the outer wall 4 side of the left ventricular apex.
The guide wire 50 is pulled until the portion of the guide wire 50 where the fixing member 20 is fixed passes through the port 60 and comes out of the left ventricle.
Here, if the length of the fixing member 20 is short, the hook-like member 10 is driven and pulled by the fixing member 20 in the pulling stage of the guide wire 50 in the procedure 6-2. In this case, the hook-shaped member 10 is pulled through the guide wire 50 and the fixing member 20. Therefore, the length of the fixing member 20 is sufficiently long to extend from the opening of the port 60 to the opening of the sheath 40 with the backflow prevention valve (see FIG. 18).

(Procedure 8-2)
Next, the guide wire 50 and the thread-like member 12 are unfixed.

(Procedure 9-2)
Next, the tubular auxiliary tool 30 is passed from the ascending aorta into the left ventricle (see FIG. 19). While pulling the fixing member 20 from the left ventricular outer wall 4, the tubular member 30 is advanced along the guide wire 50, guided from the ascending aorta to the inside of the heart via the port 60, and guided to the left ventricular interior 3. The tubular auxiliary tool 30 is advanced until it comes into contact with the inner wall of the left ventricle where the sheath 40 with a check valve is perforated (see FIG. 19). Pull the guide wire 50 away. Further, the sheath 40 with the backflow prevention valve is removed from the outer wall of the left ventricle.

According to the above procedure, the rod-like member 10 is introduced into the body from the outside of the body with the bottom portion thereof facing the inside of the body while being inserted into the lumen of the tubular member 3, thereby performing the introduction into the body in a minimally invasive manner. be able to.
In addition, although the said procedure was shown as an introductory procedure of the saddle-shaped member 10 to a left ventricle, the ventricle affected part prosthesis and prosthesis set of this invention can also introduce the prosthetic-member 10 into the right ventricle. The procedure for introducing the saddle-like member 10 into the right ventricle is the same as the procedure 1 to 12 for introducing the saddle-like member 10 into the left ventricle as described above, replacing “left ventricle” with “right ventricle” and “ascending aorta” with “ The term “ascending vena cava” may be read as appropriate, introduced in the same manner, and placed in the right ventricle.

  As described above, the configuration example and the usage method of the ventricular disease part prosthesis and the prosthetic device set according to the present invention have been described based on the drawings, but the present invention is not limited thereto, and the configuration of each part has the same function. It can be replaced with any configuration having. Moreover, other arbitrary structures and functions may be added to the present invention.

  As a ventricular diseased part prosthesis according to the second embodiment, a configuration example in which a hook-like member 10b is formed of a spring material 11 and a film 12 will be described.

  The shape of the bowl-shaped member 10b does not necessarily have to be symmetrical as in the first embodiment.

  The spring material 11 of the bowl-shaped member 10b can have various structures for contraction and expansion.

In the first structure example, as shown in FIG. 20, a plurality of circular members that form a meandering pattern along the outer side or the inner side of the bowl-shaped member 10 are arranged. The structure example of FIG. 20 has a configuration in which a circular member 11a of a wave spring is arranged along the outer shape of the bowl-shaped member 10b. Similarly, there may be a structure in which the circular member 11a forms a wavy, zigzag or sawtooth pattern.
If the circular member 11a is a spring material that contracts and expands in the inner diameter direction, the entire flange-shaped member 10b has a structure that contracts and expands in the inner diameter direction. When the circular member 11a is formed using a material having a shape memory function and superelasticity, as shown in FIG. 22, the flange-shaped member 10b contracts and expands in the inner diameter direction as the spring material 11, and expands and contracts. Can function.

  In the second structural example, as shown in FIG. 21, a plurality of circular members forming a zigzag pattern are arranged along the outer side or the inner side of the bowl-shaped member 10, and the shape is not symmetrical. It is.

  Here, although the material of the spring material 11 is not specifically limited, For example, stainless steel, titanium (Ti), tantalum (Ta), nitinol (Ni-Ti alloy), etc. are mentioned.

In the second structure example, as shown in FIGS. 23 (a) and 23 (b), the wire is bent and knitted into a mesh shape so that it can be expanded and contracted vertically and horizontally, and the spring material 11b of the hook-shaped member 10b is formed. It is. FIG. 23A shows a side view and FIG. 23B shows a front view.
It is preferable to use a material that has a shape memory function and is super-elastic as a wire material so that the wire knitted into a mesh shape can easily expand and contract. By adopting such a structure that can be expanded and contracted vertically and horizontally, the expansion and contraction function can be exhibited as shown in FIGS. 24A and 24B when contracted in the inner diameter direction.

  The expansion / contraction function of the ventricular diseased part prosthesis according to the second embodiment is formed by forming the hook-shaped member 10b with the spring material 11 having the expansion / contraction function as shown in the first structure example and the second structure example. Is obtained.

  When the collar member 10b is formed of a spring member 11 such as a circular member or a wire mesh, blood permeates as it is and cannot be used as a prosthetic device for ventricular septal perforation. Therefore, it is necessary to perform surface treatment so that blood does not penetrate. The ventricular disease part prosthesis of the second embodiment includes a cloth-like member 12 that covers at least a part of the outer surface or the inner surface of the spring material 11.

  FIG. 25 is a diagram showing a configuration example of a ventricular diseased part prosthesis in which the outer surface of the spring material 11b of the collar-like member 10b when the second wire mesh is adopted is covered with the cloth-like member 12. In FIG. 25, a part of the cloth-like member 12 is omitted for easy understanding of the internal wire mesh structure.

  The material of the cloth-like member 12 is not particularly limited, and for example, those generally used for artificial blood vessels are suitable. For example, various resin materials such as polyethylene terephthalate (PET, dacron, tetron, etc.), polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE) and polyurethane, which are a kind of saturated polyester, And combinations of two or more of these.

Next, the fixing member 20 will be described.
In the case of the configuration of the second embodiment, the fixing member 20 can be attached to either or both of the spring material 11 and the cloth-like member 12. When a thread-like member is used as the fixing member 20, the fixing member 20 that is a thread-like member is attached to either or both of the spring material 11 and the cloth-like member 12 in a region where the spring material 11 and the cloth-like member 12 overlap. In the case where the hook-shaped member 10b is composed of the spring material 11 and the cloth-shaped member 12 covering at least a part of the outer surface thereof, for example, it is attached to the outer diameter side of the spring material 11 or the inner diameter side of the cloth-shaped member 12. The two openings provided in the vicinity of the bottom of the spring material 11 are passed twice, and the cloth member 12 is further distant from the cloth member 12 through the opening provided in the vicinity of the bottom of the spring material 11. It can be extended toward the end.

  In the configuration example shown in FIG. 25, the four thread-shaped fixing members 20 are attached to the outer diameter side of the spring material 11 and slightly below the upper edge of the collar, and near the bottom of the spring material 11. The two provided openings are passed twice, and are extended toward the distal end of the cloth-like member 12 through the opening provided in the region covering the bottom of the spring material 11 in the cloth-like member 12. This is because, when the ventricular diseased part prosthesis according to the second embodiment is placed by the same placement procedure as that of the first embodiment, the hook-like member 20 is pulled from the outside of the ventricle during the placement procedure 11, thereby This is a device that makes it possible to control 10 postures.

  The placement procedure of the ventricular diseased part prosthesis according to the second embodiment may be the same as the placement procedure shown in the first embodiment.

  In the indwelling procedure of the hook-shaped member 10b, the spring material 11 is contracted / expanded by the spring structure, and therefore the cloth-shaped member 12 is preferably contracted / expanded together.

As a ventricular diseased part prosthesis according to Example 3, a so-called “maple” is provided near the upper edge of the bowl-shaped member 10c.
Here, “bare” is a protrusion-like structure provided near the upper edge of the bowl-shaped member 10c, and resists the hook-shaped member 10c from moving by biting into the inner wall of the ventricle.

  FIG. 26 is a diagram showing a configuration example in which a spine-shaped “barb” structure 13a is provided near the upper edge of the hook-shaped member 10c. As shown in FIG. 26, a plurality of barbed “barb” structures 13a extending in the distal direction are attached in the vicinity of the upper portion of the hook-shaped member 10c. When the saddle-like member 10c is placed in the ventricle, the “barbet” structure 13a bites into the ventricular wall, and the saddle-like member is stably placed.

  FIG. 27 is a diagram showing another preferred structure example of the “maple” structure 13, and is a diagram showing a configuration example in which a pointed portion near the upper edge of the hook-shaped member 10 c is a “maple” structure 13 b. is there. In the “maple” structure 13b shown in FIG. 27, the pointed portion of the mountain has a maple structure.

  The indwelling procedure of the ventricular diseased part prosthesis according to the third embodiment may be the same as the indwelling procedure shown in the first embodiment.

  In the indwelling procedure of the hook-shaped member 10c, the hook-shaped member 10c needs to pass through the tubular auxiliary tool 30, so that the “barbed” structure 13 is caught inside the tubular auxiliary tool 30 or cannot pass therethrough. If it is difficult to do, it will hinder the indwelling procedure of the bowl-shaped member 10c, which is not preferable. Therefore, it is preferable that the “barbed” structure 13 is designed to be folded so as not to be caught on the inner wall of the tubular auxiliary tool 30 in the contracted state of the hook-shaped member 10c.

  As mentioned above, although the preferable Example in the structural example of the ventricular diseased part prosthesis of this invention was illustrated and demonstrated, it is understood that various changes are possible without deviating from the technical scope of this invention. Let's go.

  The ventricular diseased part prosthesis of the present invention can be applied to a patient having a ventricular septal perforation as a jig for prosthetic ventricular septal perforation.

The figure which shows the structural example of the ventricle affected part prosthesis device concerning Example 1 of this invention. The figure which showed the structural example of the bowl-shaped member 10a which is not a left-right symmetric form The figure which shows the structural example by which the small hole 14 which can penetrate the fixing member 20 is provided in the bottom part of the bowl-shaped member 10 shown in FIG. The figure which shows the structural example by which the small hole which can penetrate the fixing member 20 is provided in the bottom part of the bowl-shaped member 10a which is not the left-right symmetric form shown in FIG. (A) is a figure which shows a mode that the tubular auxiliary tool 30 and the hook-shaped member 10 shrink | contract and expand | extend to an internal diameter direction to the magnitude | size which can pass the lumen | bore of the tubular auxiliary tool 30, (b) is a figure which shows the hook-shaped member 10. The figure which showed a mode that it shrunk and passed the lumen | bore of the tubular auxiliary tool 30 The figure explaining the indwelling procedure of the ventricular disease part prosthesis which concerns on this invention (procedure 1) The figure explaining the indwelling procedure of the ventricular disease part prosthesis which concerns on this invention (procedure 2) The figure explaining the indwelling procedure of the ventricular disease part prosthesis which concerns on this invention (procedure 3) The figure explaining the indwelling procedure of the ventricular disease part prosthesis which concerns on this invention (the procedure 4 1) The figure explaining the indwelling procedure of the ventricular disease part prosthesis which concerns on this invention (procedure 4 2) The figure explaining the indwelling procedure of the ventricular disease part prosthesis which concerns on this invention (the procedure 5 1) The figure explaining the indwelling procedure of the ventricular disease part prosthesis which concerns on this invention (the procedure 5 2) The figure explaining the indwelling procedure of the ventricular disease part prosthesis which concerns on this invention (procedure 6, procedure 7) The figure explaining the indwelling procedure of the ventricular disease part prosthesis which concerns on this invention (procedure 8, procedure 9) The figure explaining the indwelling procedure of the ventricular disease part prosthesis which concerns on this invention (procedure 10, the procedure 11, the procedure 12) The figure which shows a mode that the saddle-shaped member 10 is passed through the inside of the tubular auxiliary tool 30 in the hand of a practitioner. The figure which shows a mode that the guide wire 50 and the fixing member 20 attached to the bowl-shaped member 10 are tied together and fixed. The figure which shows a mode that the fixing member 20 fixed to the guide wire 50 is pulled. The figure which shows a mode that the tubular auxiliary tool 30 is moved to the position where the bottom part reaches | attains a left ventricular interior wall. The figure which shows the structural example of the spring material 11a which has arrange | positioned the several circular member which forms the meandering pattern along the outer side or inner side concerning Example 2 of this invention. The figure which shows the structural example of the spring material 11a which is not symmetrical The figure which shows a mode that the spring material 11a concerning FIG. 20 was contracted. The figure which shows the structural example of the spring material 11b concerning Example 2 of this invention by bend | folding a wire so that it can expand-contract vertically and horizontally, and knitting it in the shape of a mesh. The figure which shows a mode that the spring material 11b concerning FIG. 23 was contracted. The figure which showed the structural example of the ventricle affected part prosthesis which covered the surface of the spring material 11b of the collar-shaped member 10b at the time of employ | adopting a 2nd wire mesh with the cloth-shaped member 12. The figure which shows the structural example which provided the spine-like "maple" structure 13a near the upper edge of the bowl-shaped member 10c The figure which shows the example of a structure which made the pointed point of the mountain near the upper edge of the bowl-shaped member 10c into the "maple" structure 13b

Explanation of symbols

10, 10a, 10b, 10c Saddle-shaped member 11a, 11b Spring material 12 Cloth-like member 13a, 13b Folding structure 20 Fixing member 30 Tubular auxiliary device 40 Sheath with backflow prevention valve 50 Guide wire 60 Port 70 Basket catheter

Claims (3)

A substantially saddle-shaped ventricular diseased prosthesis that fits within the heart chamber,
A hook-shaped member formed of a spring material capable of contraction / relaxation, and capable of contraction / relaxation in at least the inner diameter of the heel according to contraction / relaxation of the heart;
A cloth-like member that covers at least a part of the outer wall surface of the spring material and can be contracted / relaxed by the contraction / relaxation of the spring material;
A plurality of fixing members for fixing the saddle-shaped member in the heart chamber of the heart;
A plurality of small holes for insertion of the fixing member in the bowl-shaped member,
At least one of the fixing members is a thread-like member, one end thereof is fixed to the outer wall surface of the hook-shaped member, and the other end is inserted along one outer hole along the outer wall surface of the hook-shaped member to insert the small hole. It is led into the inside of the saddle-shaped member, and further led out from the other small hole to the outside and fixed to the ventricle of the heart, and the posture of the saddle-shaped member is adjusted by fixing the plurality of fixing members, and the heart A ventricular diseased part prosthesis that is placed in a ventricle and is placed so as to close the affected part of the ventricle of the heart. The ventricular diseased part prosthesis according to claim 1,
A tubular auxiliary device that secures a penetration path into the ventricle of the heart,
The rod-shaped member can be contracted in the rod inner diameter direction to a size that passes through the lumen of the tubular auxiliary tool,
Inserting or penetrating the tubular auxiliary device into the heart such that one end of the opening is outside the heart and the other end is inside the heart chamber;
The hook-shaped member is allowed to pass through one end of the opening of the tubular assisting tool while being contracted in the inner diameter direction of the tubular assisting tool so that it can be passed through the lumen of the tubular assisting tool. Ventricular prosthetic treatment, wherein the prosthetic device is guided into the ventricle, and after passing through the other end of the opening, the saddle-shaped member is restored to a generally saddle shape that fits in the ventricle of the heart and is placed in the ventricle of the heart. set.   The ventricular diseased part prosthetic treatment set according to claim 2, wherein the tubular auxiliary device includes a backflow prevention valve, and blood does not flow back from the heart chamber of the heart even if it penetrates into the heart chamber of the heart.

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