JP2009072258A - Arterial septal defect hole closing device - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To achieve a minimally invasive treatment for a patient by performing a procedure without requiring a large skin incision, performing extracorporeal circulation, causing a heart to stop beating, and leaving a large foreign matter in the heart in closing a defect hole of atrial septal defect. <P>SOLUTION: An atrial septal defect hole closing device 1 is equipped with a suture member 2 formed by gathering proximal end sides of a plurality of elastic wire materials 10, 10... in a columnar shape and integrating them, suture needles 3 mounted on distal end parts of the respective wire materials 10, and suture threads 4 connected to the suture needles 3 for suturing an arterial wall on the marginal wall of the defect hole in an arterial septum. Each of the wire materials 10 is curved in a manner to be located radially more outward of the suture member 2 toward the distal end. The suture needle 3 is disposed to project to the proximal end side of the wire material 10. The degree of the curvedness of the distal end side of the wire material 10 is adjustable. <P>COPYRIGHT: (C)2009,JPO&INPIT

Description

  The present invention relates to an atrial septal defect hole closure device used when closing a defect hole of an atrial septum.

  The heart includes a right atrium that accepts blood returning from the whole body to the heart, a right ventricle that sends blood returned to the right atrium to the lungs, and a left atrium that receives blood returned from the lungs and sent to the whole body. It has a left ventricle that sends blood that has returned to the left atrium to the whole body, and four heart valves that open and close the atrium and the ventricle. There is an atrial septum between the right and left atria to prevent both blood from mixing, and there is a ventricular septum between the right and left ventricles as well.

  By the way, when you are a fetus, you don't need to breathe yourself, so anyone has a hole in the atrial septum and blood flows from the right atrium to the left atrium. By starting to breathe the lungs, the atrial septal hole closes and becomes a dent. In rare cases, however, the atrial septum may remain open after birth, leaving it as a defect hole. This disease is called patent foramen ovale. Furthermore, a defect hole may remain in the atrial septum due to an abnormality in the process of forming the atrial septum, which is called atrial septal defect. In atrial septal defect, blood flows more easily in the lungs than in the whole body, so the blood in the left atrium flows into the right atrium through the defect hole in the atrial septum and into the right atrium from the right ventricle through the lungs. Blood will circulate redundantly in the route until it returns, which will put an excessive burden on the right ventricle and lungs. Therefore, patients with atrial septal defect develop heart failure during childhood or cause arrhythmias such as atrial fibrillation after they become older.

  In this way, a part of the atrial septum that should normally be closed is missing and a hole is made, which can cause an inappropriate flow of blood in the heart and cause various diseases. In order to solve this, it is necessary to close the defect hole of the atrial septum. As a method of closing the defect hole, the method of stopping the heart, opening the right atrium, and closing the defect hole under direct vision has been used since about 50 years ago when the extracorporeal circulation that oxygenates blood and sends it to the whole body was developed. It was done. In this method, in order to close a defect hole with a diameter of about 1 cm to 2 cm, in addition to making a large skin incision of about 20 cm in the anterior chest, the midline of the sternum is incised vertically, and an extracorporeal cardiopulmonary apparatus is used to external It was necessary to establish circulation and stop the heart. For this reason, complications due to extracorporeal circulation and cardiac arrest may occur. That is, in order to close a defect hole having a diameter of about 1 cm to 2 cm at the most, the patient was given a very large invasion.

  Later, in the treatment of atrial septal defect, a method of closing the defect hole with a small incision such as intercostal thoracotomy or partial incision of the sternum was introduced. Although this method eliminated the need for large skin incisions, the process of opening the heart was still essential, so the situation of extracorporeal circulation and cardiac arrest remained unchanged.

Therefore, in recent years, medical treatment of atrial septal defect has been performed (see, for example, Patent Document 1). The instrument disclosed in Patent Document 1 includes a closing member that closes the defect hole and a catheter that accommodates the closing member. When using this instrument, the catheter containing the closure member is inserted into the heart through the groin vein, and the closure member is pushed out of the catheter with the ultrasound echo device guided through the defect hole. Thus, the defect hole can be closed by the closing member. This method is excellent in that the defect hole can be closed without stopping the heart and without using extracorporeal circulation while keeping the heart pulsating as usual.
Special table 2003-509175 gazette

  However, the method of closing the defect hole with the closing member as in the instrument of Patent Document 1 has some problems as described below.

  The first problem is the displacement of the closing member. The appropriate size of the closure member depends on the size of the defect hole. If the size of the closure member does not fit the defect hole, the closure member that should have been fixed to the atrial septum will be displaced and the defect hole will be partially Open to the blood flow from the left atrium to the right atrium, resulting in incomplete treatment.

  The second problem is that a large foreign body called a closing member remains in the atrial septum. Although the closure member is later coated with the intima, it will remain for a lifetime by projecting from the central part of the atrial septum to the left and right atrial side. The right atrium is a place where bacteria or the like entering from a vein always pass, and there is a risk of infection of the closure member.

  A third problem is that after treatment of an atrial septal defect, there are limitations in performing another catheter treatment. As described above, patients with atrial septal defect continue to be overloaded on the right atrium, so it is not uncommon for atrial fibrillation to occur later. When atrial fibrillation occurs, it is easy to form a thrombus in the left atrium, and the thrombus may fly to the brain and clog the cerebral artery, causing cerebral infarction. Even without atrial septal defect, the risk of atrial fibrillation increases with age. In recent years, a catheter ablation method has been introduced as a treatment method for this atrial fibrillation. This catheter ablation method is a method in which the catheter is advanced from the groin or cervical vein toward the heart, advanced to the left atrium through the atrial septum, and the arrhythmia generation circuit is electrically burned out by high-frequency current. It is likely to become general. However, when there is a large foreign body such as a closing member in the atrial septum, it is difficult to perform such catheter treatment, and it is easily expected that a surgical treatment that gives a large invasion will be required.

  The present invention has been made in view of such a point, and the object of the present invention is to close a defect hole in the atrial septum of the heart without requiring a large skin incision, and to extracorporeally. An object of the present invention is to realize a minimally invasive treatment for a patient without causing circulation and cardiac arrest and without leaving a large foreign body in the heart.

  In order to achieve the above object, in the present invention, a proximal end side of a plurality of elastic wire rods is integrated to form a suture member, and the distal end side of the wire rod is bent radially outward, and the distal end portion of the wire rod In addition, a suture needle to which a suture thread is connected is attached, and the bending degree of the wire can be adjusted.

  Specifically, in the first invention, the atrial septal defect closing device used when closing the defective hole in the atrial septum of the heart, wherein the proximal end sides of a plurality of elastic wires are columnar And a suture member attached to the distal end portion of each wire, and a suture thread connected to the suture needle, the wire being closer to the tip, the suture. It is bent so as to be located radially outward of the member, and the suture needle is disposed so as to protrude toward the proximal end side of the wire, and the suture member has a degree of bending on the distal end side of the wire. It is assumed that an adjustment unit for adjustment is provided.

  According to this configuration, it becomes possible to close the defect hole of the atrial septum as follows. That is, the diameter of the suture member is reduced by reducing the degree of bending of the distal end side of each wire by the adjustment portion of the suture member, so that only a small skin incision, for example, a small incision is made in the right atrial wall The suture member can be inserted into the right atrium from the distal end side of the wire. Because such a small incision is sufficient, extracorporeal circulation and cardiac arrest are not necessary. Then, with the distal end portion of the suture member inserted into the right atrium inserted into the left atrium through the defect hole, the adjustment portion increases the degree of bending of the distal end side of the wire to increase the diameter of the suture member on the distal end side. If it enlarges, the front-end | tip part of a wire will be located in the edge part of a defect | deletion hole. In this state, when the suture member is pulled toward the proximal end side of the wire rod, the suture needle protrudes toward the proximal end side of the wire rod, so that it penetrates the edge portion of the defect hole of the atrial septum. On the other hand, when the atrial wall is pressed in a direction in contact with the atrial septum and brought into contact with the atrial septum, the suture needle penetrates the atrial wall and protrudes outward from the atrium, and comes out to the surgical field. By pulling the suture needle away from the wire rod, the atrial wall is sutured to the edge of the defect hole of the atrial septum by the suture thread connected to the suture needle, and the defect hole is closed.

  In the second invention, in the first invention, both ends of one suture are connected to two suture needles, respectively.

  According to this configuration, the two suture needles to which both ends of the suture thread are connected are detached from the wire in a state of passing through the atrial septum and tied with the suture thread, thereby closing the defect hole. It becomes possible to form seams.

  In a third invention, in the first or second invention, the adjustment portion is configured by a cylindrical member fitted to the outer peripheral portion of the suture member, and the inner diameter of the cylindrical member is larger than the diameter on the distal end side of the suture member. The configuration is set small.

  According to this configuration, when the tubular member is fitted to the outer peripheral portion of the suturing member and moved to the distal end side of the suturing member, the degree of bending of the distal end side of the wire becomes small and the distal end side diameter of the suturing member becomes larger. On the other hand, when the tubular member is moved from this state to the proximal end side of the suture member, the shape of the wire is restored and the distal end side diameter of the suture member is increased. That is, it is possible to adjust the diameter on the distal end side of the suture member simply by moving the tubular member in the axial direction of the suture member.

  According to a fourth invention, in any one of the first to third inventions, the suturing member is accommodated in the sheath.

  According to this configuration, the suture member can be introduced into the atrium while being accommodated in the sheath.

  According to a fifth invention, in any one of the first to fourth inventions, the suturing member is introduced into the atrium by the port constituting member.

  According to this configuration, the suture member can be introduced into the atrium via the port of the port component member.

  According to the first invention, the base end sides of the plurality of elastic wires are integrated to form a suture member, the distal end side of the wire is bent outward in the radial direction, and the suture thread is attached to the tip of the wire. In addition, it is possible to adjust the degree of bending of the wire, so that no large skin incision is required, and extracorporeal circulation and cardiac arrest are not required. The defect hole can be closed without leaving. Thereby, a minimally invasive treatment for the patient can be realized.

  According to the second invention, since both ends of one suture are respectively connected to the two suture needles, the defect hole can be closed only by detaching the two suture needles from the wire and tying the sutures. A seam can be formed, and the defect hole can be reliably closed.

  According to the third aspect of the present invention, the degree of bending of the distal end side of the wire can be easily adjusted simply by moving the tubular member in the axial direction of the suture member. Can be adjusted.

  According to the fourth invention, since the suture member can be introduced into the atrium while being housed in the sheath, the procedure can be made safe and less invasive treatment can be performed.

  According to the fifth aspect, the suture member can be smoothly introduced into the atrium, and a less invasive treatment can be performed.

  Hereinafter, embodiments of the present invention will be described in detail with reference to the drawings. It should be noted that the following description of the preferred embodiment is merely illustrative in nature, and is not intended to limit the present invention, its application, or its use.

  FIG. 1 shows an atrial septal defect hole closing device 1 according to an embodiment of the present invention. In the description of this embodiment, the anatomy of the heart 100 having an atrial septal defect will be described based on FIG. 2 before describing the structure of the atrial septal defect hole closure device 1. The heart 100 includes a left atrium 101, a right atrium 102, a left ventricle 103, and a right ventricle 104. There is an atrial septum 105 between the left atrium 101 and the right atrium 102. In the atrial septal defect, a part of the atrial septum 105 is lost and a defect hole 106 is formed.

  As shown in FIG. 1, the atrial septal defect hole closure device 1 includes a suture member 2, a suture needle 3, and a suture thread 4, and a defect hole of a heart 100 that has developed an atrial septal defect. It is used when 106 is closed.

  The stitching member 2 includes a columnar main body 11 formed by bundling a plurality of wires 10, 10,..., And a narrowing ring (tubular member) 12 that changes the shape of the main body 11. For example, the number of the wires 10 constituting the stitching member 2 is set to an even number of 10 or more and 16 or less. The number of the wires 10 can be set to an arbitrary number. Each wire 10 is formed by processing an elastic material. The material constituting the wire 10 may be, for example, a metal material such as spring steel or a resin material. The length of each wire 10 is set to 100 mm or more and 300 mm or less, and the thickness is set to 0.5 mm or more and 2.0 mm or less.

  As shown in FIG. 3, the base end side of each wire 10 (upper side of FIGS. 1 and 3) extends straight, while the distal end side (lower side of FIGS. 1 and 3) draws a smooth curve. It is formed so as to be curved. The degree of curvature on the distal end side of the wire 10 is set so that the curvature becomes tighter toward the distal end. All the wires 10 have the same shape.

  The proximal end side of the wire 10 is gathered and integrated so as to form a columnar shape. When the base end side of the wire 10 is integrated, for example, it may be integrated by welding or an adhesive, or may be integrated by binding with a binding member (not shown). . The bending direction on the distal end side of these wire rods 10, 10,... Is set so as to be directed outward in the radial direction of the main body portion 11 of the suturing member 2. Therefore, as shown in FIG. When viewed from the end side, the wire rods 10, 10,... Extend radially, and the tip portions of the wire rods 10, 10,... Are positioned so as to line up on a virtual circle centering on the axis of the main body portion 11. Will be. Further, by setting the bending direction of the wire rods 10, 10,... As described above, the suture member 2 has a shape in which the diameter increases toward the distal end side of the wire rod 10, as shown in FIG.

  A needle gripping mechanism for gripping the suture needle 3 is provided on the distal end side of each wire 10. As shown in FIG. 4, the needle gripping mechanism includes a first gripping portion 10 a formed at the distal end portion of the wire rod 10, and a protrusion that protrudes from a portion farther to the proximal end side of the wire rod 10 than the first gripping portion 10 a. Part 10c and a second gripping part 10b formed at the tip of the protruding part 10c. The first gripping part 10a and the second gripping part 10b are separated in the axial direction of the main body part 11. . The protruding length and the protruding direction of the protruding portion 10c are set so that both the holding portions 10a and 10b overlap each other when the first holding portion 10a and the second holding portion 10b are viewed from the axial direction of the main body portion 11. Has been. Further, as shown in FIG. 5, the first gripping portion 10 a and the second gripping portion 10 b have a shape in which a part of the ring is cut out, that is, a substantially C-shape when viewed from the axial direction of the main body 11. The first gripping portion 10a has a smaller diameter than the second gripping portion 10b. The cut-out range of the first grip 10a and the second grip 10b is about 3/8 in the circumferential direction. Although details will be described later, the suture thread 4 passes through the notched portion. In addition, the shape of the 1st holding part 10a and the 2nd holding part 10b can be arbitrarily set according to the shape of the suture needle 3. FIG.

  On the other hand, the diaphragm ring 12 is formed by connecting a large diameter portion 12a and a small diameter portion 12b in the axial direction. The axis of the large diameter part 12a and the axis of the small diameter part 12b are located concentrically. The throttle ring 12 is arranged so that the small diameter portion 12 b is positioned on the proximal end side of the suture member 2, and fits to the outer peripheral portion of the suture member 2. The inner diameter of the small diameter portion 12b is set to be slightly larger than the outer diameter on the proximal end side of the main body portion 11 of the suture member 2. The inner diameter of the large-diameter portion 12 a is set smaller than the outer diameter on the distal end side of the main body portion 11 of the suture member 2.

  As shown by the arrow in FIG. 1, when the aperture ring 12 is moved to the proximal end side of the suture member 2, the wire 10 has a shape at the time of molding. On the other hand, as shown by the arrow in FIG. 6, when the aperture ring 12 is moved toward the distal end side of the suture member 2, the diameter of the large diameter portion 12 a is smaller than the diameter on the distal end side of the main body portion 11. The peripheral edge of the portion 12a is in sliding contact with the wire rods 10, 10,. As a result, the wire rods 10, 10,... Are elastically deformed in a direction in which the degree of bending is reduced, thereby reducing the diameter on the distal end side of the body portion 11 of the suture member 2. That is, by moving the aperture ring 12 in the axial direction of the main body 11, it is possible to adjust the degree of bending of the wire rods 10, 10,. Moreover, in the state which made the diameter of the main-body part 11 of the stitching | suture member 2 small, as shown in FIG. Furthermore, the position where the aperture ring 12 is stopped can be arbitrarily set.

  The suture needle 3 and the suture thread 4 are used for biological tissue sutures used in general medical sites. As shown in FIGS. 1, 3, and 4, the suture needle 3 is an intact needle that can easily penetrate the walls of the atrial septum 105 and the right atrium 102, and the distal end thereof is the proximal side of the wire 10. It is arranged so as to protrude toward the side and is held by the needle holding mechanism of the wire 10. That is, the suturing needle 3 is tapered so that a portion slightly closer to the tip than the base end is thickest. The diameter of the base end portion of the suture needle 3 is set to coincide with the inner diameter of the first gripping portion 10a of the wire rod 10, and the base end portion is adapted to fit into the first gripping portion 10a. The diameter of the thickest part of the suture needle 3 is set to be slightly larger than the inner diameter of the second gripping portion 10b. Therefore, the part slightly proximal to the thickest part of the suture needle 3 is the second part. It fits into the grip 10b. As shown in FIG. 5A, a hole 3 a into which the end of the suture thread 4 is inserted is formed at the proximal end of the suture needle 3. The end portion of the suture thread 4 is fixed by caulking so that it does not come out when it is inserted into the hole 3 a of the suture needle 3.

  When the suturing needle 3 is gripped by the needle gripping mechanism of the wire rod 10, the suturing needle 3 is disposed above the second gripping portion 10b (upper side in FIG. 4) and then moved downward to move the base end of the suturing needle 3 The portion is passed through the second gripping portion 10b and fitted into the first gripping portion 10a, and a portion slightly proximal to the thickest portion of the suture needle 3 is fitted into the second gripping portion 10b. As a result, two longitudinal directions of the suture needle 3 are gripped by the wire 10, and the suture needle 3 does not fall down when puncturing the atrial septum 105 or the wall of the right atrium 102. Further, since the suture needle 3 is fitted in the first grip 10a and the second grip 10b at the time of puncturing, it does not shift in the axial direction.

  Further, the number of the suture needles 3 is the same as the number of the wire rods 10, and the distal ends thereof are formed as described above. Therefore, as shown in FIG. 7, the suture member 2 is viewed from the proximal end side. Sometimes, they are arranged on a virtual circle centered on the axis of the main body 11. Further, both end portions of one suture thread 4 are connected to the proximal end portions of the suture needles 3 and 3 adjacent to each other in the circumferential direction of the virtual circle.

  Next, two methods of using the atrial septal defect hole obturator 1 configured as described above will be described. The first method is a right atrial patch method in which a part of the wall of the right atrium 102 that has expanded due to an atrial septal defect is used as a patch for closing the defect hole 106, and FIG. This will be described with reference to FIG. The number of wires 10 of the atrial septal defect hole obturator 1 is set in advance according to the shape and size of the defect hole 106.

  First, as shown in FIG. 8, the aperture ring 12 is moved to the distal end side of the suture member 2 to reduce the diameter of the suture member 2, and the suture member 2 is accommodated in the sheath 20 in this state. The sheath 20 also stores the suture needle 3 and the bundled suture 4. The suture 4 is preferably bundled using a weak adhesive or the like. The sheath 20 is made of a flexible resin material. On the other hand, the patient is exposed to the right atrium 102 by intercostal thoracotomy after a small skin incision for introducing the atrial septal defect hole obturator 1 is made between the right fourth and fifth ribs.

  Thereafter, as shown in FIG. 9, a cigarette suture (pouch suture) 21 is put on the wall of the right atrium 102 and a small incision is made to form an incision hole 110. Then, the suture member 2 is inserted into the right atrium 102 through the incision hole 110 while being kept in the sheath 20. The position where the cigarette suturing thread 21 is applied, that is, the position where the small incision is to be made, is determined while viewing the echo image obtained by the ultrasonic echo device and various examination results before the operation. Specifically, it is a position facing the defect hole 106 in the atrial septum 105.

  The sheath 20 is inserted into the defect hole 106 in the atrial septum 105 while viewing the image of the ultrasonic echo device, and protrudes toward the left atrium 101 side. At this time, the aperture ring 12 is located in the right atrium 102. Thereafter, with the proximal end side of the suture member 2 held so as not to move, only the sheath 20 is removed from the right atrium 102 to the outside (front side of the operator) as shown in FIG. Tighten the thread 21. Then, as indicated by an arrow in FIG. 11, the diaphragm ring 12 is moved to the proximal end side (the operator's front side) of the suture member 2. Then, the shape of the wire rods 10, 10,... Is restored, and the diameter of the distal end side of the main body portion 11 of the suture member 2 is expanded. Accordingly, as shown in FIG. 12, the tips of the suture needles 3, 3,... Are positioned so as to face the edge portion of the defect hole 106. The squeezing ring 12 exits from the incision hole 110 to the outside of the right atrium 102. At this time, it is also possible to adjust the diameter of the distal end side of the main body 10 depending on the position of the aperture ring 12 while keeping the aperture ring 12 fitted to the suture member 2.

  Next, as shown by an arrow in FIG. 13, when the suture member 2 is pulled to the front side of the operator (the proximal end side of the suture member 2), the distal ends of the suture needles 3, 3. 14, the suture needles 3, 3,... Penetrate the marginal portion of the defect hole 106 of the atrial septum 105 from the left atrium 101 side to the right atrium 102 side, as shown in FIG. Projecting to 102. This is confirmed by the image of the ultrasonic echo device. Thereafter, as shown in FIG. 15, the pusher ring 23 is pressed from the outside of the right atrial wall 102 toward the atrial septum 105, and the suture member 2 is pulled to the front side of the operator, so that the wall of the right atrium 102 is moved to the atrium. Contact the septum 105. The pusher ring 23 is an instrument provided with a ring-shaped part for pressing a living tissue and a handle part extending from the ring-shaped part.

  When the wall of the right atrium 102 contacts the atrial septum 105, as shown in FIG. 16, the suture needles 3, 3,... Penetrate through the wall of the right atrium 102 and project outside the right atrium 102 to enter the operative field. Come. The suture needles 3, 3,... Projecting outside the wall of the right atrium 102 are only gripped while being fitted to the first gripping portion 10a and the second gripping portion 10b of the wire rods 10, 10,. Then, each suture needle 3 is grasped by the forceps W and pulled toward the operator's front side (upper side in FIG. 16), so that the suture needle 3 is easily detached from the distal end portion of the wire 10 as shown in FIG. When the suture needle 3 is detached from the distal end portion of the wire rod 10, the suture thread 4 goes out of the grip portions 10a and 10b through the cut portions of the first grip portion 10a and the second grip portion 10b. The suture needle 3 may be weakly bonded to the first grip portion 10a or the second grip portion 10b with an adhesive.

  Then, as shown in FIG. 18, when the suture needle 3 is pulled as it is, the suture thread 4 comes out of the right atrium 102 while unwinding. Since both ends of the suture thread 4 are connected to the adjacent suture needles 3 and 3, a knot can be formed by tying the suture threads 4 connected to the suture needles 3 and 3. 19, the wall of the right atrium 102 is stitched around the defect hole 106 of the atrial septum 105 to function as a patch, and the defect hole 106 is closed. The pusher ring 23 is separated from the right atrium 102 after the suture 4 is tied.

  Further, after the suture needle 3 is detached from the wire 10, as shown in FIG. 18, the aperture ring 12 is moved to the distal end side of the main body portion 11 to reduce the diameter of the main body portion 11. The outside of the right atrium 102 is pulled out, the cigarette suture thread 21 is tied, and the incision hole 110 is closed.

  All these procedures can be performed under the direct vision of the operator and under an echo guide by an ultrasonic echo device. In the case of echo guide, transesophageal echocardiography (TEE) may be used, and real-time 3D-TEE is suitable for this procedure.

  If the wall of the right atrium 102 remains sewn to the atrial septum 105, blood flow may be inhibited and a thrombus may be formed. For this reason, as shown in FIG. 20, after the tobacco suture thread 24 is hung on the outer side of the right atrial wall 102, the outer side of the right atrial wall is sutured. The inner side of the yarn 24 is cut with a blade 25, and the wall of the right atrium 102 is separated from the atrial septum 105 as shown in FIG. Then, as shown in FIGS. 22 and 23, the suture suture thread 24 is tied and the hole in the wall of the right atrium 102 is closed. In this way, the defect hole 106 of the atrial septum 105 is closed.

  Since the diameter of the suture member 2 can be reduced as described above, the suture member 2 is inserted into the right atrium 102 without making a large skin incision in the patient, and without making a large incision in the heart 100. The hole 106 can be closed. Thus, since there is no need to open the right atrium 102, extracorporeal circulation and cardiac arrest are unnecessary. In addition, since only the suture thread 4 remains in the heart 100, there is almost no fear of bacterial infection, and there is no restriction when performing another catheter treatment, and for example, a catheter ablation method can be performed without any problem. .

  It should be noted that the atrial septal defect hole closing device 1, the sheath 20, and the pusher ring 23 may be set as a set, or any two of them may be set as a set.

  Next, a second method of using the atrial septal defect hole closing device 1 will be described with reference to FIGS. The second method of use is a direct suturing method in which the atrial septal defect hole closure 1 is introduced into the right atrium 102 by the port component 30 and the defect hole 106 is directly sutured. When used in this direct suturing method, both ends of the suture thread 4 are located at the proximal ends of the suturing needles 3, 3 facing each other, as shown in FIG. Connect each one. Further, the same mark is attached to the pair of suture needles 3 and 3 to which one suture thread 4 is connected. This mark can be composed of numbers, symbols, colored portions of the same color, and the like.

  First, the diaphragm ring 12 is moved to the distal end side of the suture member 2 to reduce the diameter of the suture member 2, and the suture member 2 is accommodated in the sheath 20 in this state. Thereafter, a small incision is made in the wall of the right atrium 102 to form an incision hole 110, and the port component 30 is inserted into the right atrium 102 through the incision hole 110 as shown in FIG. A cigarette suture thread 31 (shown only in FIG. 34) is placed around the incision hole 110. The port component 30 projects from the wall of the right atrium 102 both outwardly and inwardly. A check valve (not shown) is provided inside the port component 30 so that blood in the right atrium 102 does not leak.

  The suture member 2 is inserted into the defect hole 106 from the port constituting member 30 through the right atrium 102 while being accommodated in the sheath 20, and is protruded to the left atrium 101 side. At this time, the aperture ring 12 is located in the right atrium 102. Thereafter, with the proximal end side of the suture member 2 held so as not to move, only the sheath 20 is pulled out from the right atrium 102 as shown in FIG. Then, as shown by an arrow in FIG. 27, the aperture ring 12 is moved to the proximal end side of the suture member 2. Then, the shape of the wire rods 10, 10,... Is restored, the diameter of the suture member 2 on the distal end side is enlarged, and the distal ends of the suture needles 3, 3,. The diaphragm ring 12 exits the port component 30 to the outside of the right atrium 102.

  When the suture member 2 is pulled to the proximal end side, the distal ends of the suture needles 3, 3,... Face the proximal end side of the suture member 2, as shown in FIG. However, the edge of the defect hole 106 of the atrial septum 105 penetrates from the left atrium 101 side to the right atrium 102 side and protrudes to the right atrium 102. By inserting forceps (not shown) into the port component 30 and pulling the suture needles 3, 3,... With the forceps and pulling them, the proximal ends of the suture needles 3, 3,. Detach from the tip of ... As shown in FIGS. 29 to 31, when the suture needles 3, 3,... Are pulled as they are, the suture 4 goes out of the right atrium 102 through the port constituting member 30. As shown in FIG. 32, a pericardial strip 112 obtained from the patient's own pericardium is passed through the suture needle 3, and the heart strip 112 is inserted into the right atrium 102.

  Then, the suture thread 4 extending from the suture needles 3 and 3 having the same mark is surgically tied to form a knot, whereby the marginal portion of the defect hole 106 is sutured together with the pericardial strip 112 as shown in FIG. Thus, the defect hole 106 is closed. At this time, a knot can be reliably formed by using a knot pusher. The order in which the knots are formed may be the order from the portion corresponding to the upper side of the heart 100 to the lower side, or the order from the portion corresponding to the lower side of the heart 100 to the upper side.

  Thereafter, as shown in FIG. 34, the port constituting member 30 is pulled out from the right atrium 102, and the incision hole 110 is closed by tying the tobacco suture thread 31. The pericardial strip 112 may be used only when the atrial septum 105 is weak.

  This method also allows the defect hole 106 to be closed without making a large skin incision in the patient and without requiring extracorporeal circulation and cardiac arrest. In addition, since only the suture thread 4 remains in the heart 100, there is almost no fear of bacterial infection and there are no restrictions when performing another catheter treatment. Note that the atrial septal defect hole closing device 1, the sheath 20, and the port component 30 may be set as a set, or any two of these may be set as a set.

  As described above, according to the atrial septal defect hole closure device 1 according to this embodiment, a large skin incision is not required, and extracorporeal circulation and cardiac arrest are performed. Since the defect hole 105 can be closed without leaving a large foreign object, a minimally invasive treatment can be realized for the patient.

  The suture needle 3 may be bonded to the wire 10 with an adhesive and may be detached from the bonded portion, or a fragile portion is formed on the distal end side of the wire 10 and the fragile portion is used as a starting point. Then, the wire 10 may be cut and the suture needle 3 may be detached from the main body portion of the wire 10. Further, for example, the tip of the wire 10 may be bifurcated, and the suture needle 3 may be attached to the wire 10 such that the suture needle 3 is sandwiched between the tips. By doing in this way, when the suture needle 3 is detached from the wire 10, it can be easily detached from the bifurcated portion of the wire 10. The structure for attaching the suture needle 3 to the wire 10 may be any structure other than the above structure as long as the suture needle 3 can be detached from the wire 10.

  Moreover, in the said embodiment, although the shape of all the wire rods 10 is made the same, it is not restricted to this, You may make the shape of some wire rods 10 and the shape of the other wire rod 10 different. In this embodiment, the suture needles 3 are arranged so as to line up on a virtual circle centered on the axis of the main body 11, but not limited to this, by changing the shape of the wire 10, It is also possible to arrange them so as to correspond to the shape of the defect holes 106.

  Further, the atrial septal defect hole closure device 1 is not limited to the treatment for atrial septal defect, and can be applied to, for example, treatment for patent foramen ovale, and mitral stenosis It can also be applied to the purpose of closing the perforated portion of the atrial septum remaining after mitral valvular opening for symptom and catheter ablation for atrial fibrillation.

  As described above, the atrial septal defect hole closing device according to the present invention can be used, for example, when closing the defect hole by stitching the atrial wall to the edge portion of the defect hole of the atrial septum. .

It is a side view of the atrial septal defect hole closing device which concerns on embodiment of this invention. 1 is a schematic view of a heart with atrial septal defect foramen. FIG. It is a side view of a pair of wire with which a suture needle was attached. It is an enlarged view of the front-end | tip part of a pair of wire rod to which the suture needle was attached. (A) is sectional drawing in the AA line of FIG. 4, (b) is sectional drawing in the BB line of FIG. FIG. 2 is a view corresponding to FIG. 1 in a state where the diameter of the suture member is reduced. It is the figure which looked at the atrial septal defect hole closing device from the base end side of the suture member. It is a figure which shows the state which accommodated the atrial septal defect hole closing device in the sheath. It is sectional drawing of the right atrium vicinity of the heart which shows the state which inserted the atrial septal defect hole closure device accommodated in the sheath into the right atrium. FIG. 8 is a view corresponding to FIG. 7 showing a state in which the sheath is removed from the right atrium. FIG. 8 is a view corresponding to FIG. 7 showing a state in which the diameter of the suture member of the atrial septal defect hole closing device is enlarged. It is a figure which expands and shows the state before puncturing a suture needle to the atrial septum. FIG. 8 is a view corresponding to FIG. 7, showing a state in which the suture needle of the atrial septal defect hole closing device is passed through the atrial septum. FIG. 13 is a view corresponding to FIG. 12 in a state where a suture needle is punctured into the atrial septum. FIG. 8 is a view corresponding to FIG. 7 showing a state in which the atrial wall is pressed against the atrial septum by a pusher ring. FIG. 13 is a view corresponding to FIG. 12 in a state where the suture needle is grasped with forceps and separated from the wire. FIG. 8 is a view corresponding to FIG. 7 showing a state where the suture needle is detached from the wire. FIG. 8 is a view corresponding to FIG. 7 showing a state where the suture is pulled outside the right atrium. FIG. 3 is a view corresponding to FIG. 2 showing a state in which the right atrial wall is sutured to the edge portion of the defect hole of the atrial septum. FIG. 8 is a view corresponding to FIG. 7 showing a state in which the right atrial wall is sutured to a marginal portion of a defect hole in the atrial septum, and a main body portion of the suture member is pulled out of the right atrium. FIG. 3 is a view corresponding to FIG. 2 showing a state in which the right atrial wall is separated from the atrial septum. FIG. 8 is a view corresponding to FIG. 7 showing a state in which the defect hole is closed. FIG. 3 is a view corresponding to FIG. 2 showing a state in which the closing of the defect hole is completed. FIG. 6 is a view corresponding to FIG. 5 of an atrial septal defect hole closing device used for a direct suturing method. FIG. 8 is a view corresponding to FIG. 7 showing a state in which the atrial septal defect hole closing device accommodated in the sheath is inserted into the right atrium by the port constituent member in the direct suturing method. FIG. 8 is a view corresponding to FIG. 7 showing a state in which the sheath is removed from the right atrium in the direct suturing method. FIG. 8 is a view corresponding to FIG. 7 showing a state in which the diameter of the suture member of the atrial septal defect hole closing device is enlarged in the direct suture method. FIG. 8 is a view corresponding to FIG. 7 showing a state in which the suture needle of the atrial septal defect hole closing device is passed through the atrial septum in the direct suturing method. FIG. 8 is a view corresponding to FIG. 7 illustrating a state in which the suture needle is detached from the wire in the direct stitching method. FIG. 8 is a view corresponding to FIG. 7 showing a state in which some sutures are pulled outside the right atrium in the direct suture method. FIG. 8 is a view corresponding to FIG. 7 showing a state in which the main body portion of the suture member is pulled out of the right atrium and all sutures are pulled out of the right atrium in the direct suture method. It is a fragmentary sectional view of the heart which shows the state which put the pericardial strip in the marginal part of the defect hole. FIG. 28 is a view corresponding to FIG. 27 in a state where the edge portion of the defect hole is stitched. FIG. 28 is a view corresponding to FIG. 27 showing a state in which the defect hole is closed by the direct stitching method.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Atrial septal defect hole closing tool 2 Suture member 3 Suture needle 4 Suture thread 10 Wire material 11 Main-body part 12 Diaphragm ring (tubular member)
20 Sheath 30 Port component 100 Heart 101 Left atrium 102 Right atrium 105 Atrial septum 106 Defect hole

Claims (5)

An atrial septal defect hole closure device used for closing a defect hole in the atrial septum of the heart,
A suture member formed by integrating the base end sides of a plurality of wires having elasticity into a columnar shape; and
A suture needle attached to the tip of each wire,
A suture connected to the suture needle,
The wire is bent so as to be positioned radially outward of the suture member as it approaches the tip,
The suture needle is disposed so as to protrude toward the proximal end side of the wire,
An atrial septal defect hole closure device, wherein the suture member is provided with an adjustment portion for adjusting the degree of bending of the wire on the distal end side. The atrial septal defect hole closure device according to claim 1,
An atrial septal defect hole closure device, wherein both ends of one suture are connected to two suture needles, respectively. The atrial septal defect hole closure device according to claim 1 or 2,
The adjustment part is composed of a cylindrical member that fits on the outer periphery of the suture member,
An atrial septal defect closure device, wherein an inner diameter of the cylindrical member is set smaller than a diameter of a distal end side of the suture member. In the atrial septal defect hole closing device according to any one of claims 1 to 3,
An atrial septal defect hole closing device, wherein a suture member is housed in a sheath. The atrial septal defect hole closure device according to any one of claims 1 to 4,
An atrial septal defect hole closure device, wherein a suture member is introduced into an atrium by a port component.

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