JP4088978B2 - Intracardiac suture device - Google Patents

Description

 The present invention relates to an intracardiac suturing apparatus that treats a defect in a heart by suturing with a suture needle.

  For diseases inside the heart such as atrial septal defect, ventricular septal defect, valvular disease, surgery is generally performed using an artificial cardiopulmonary device (extracorporeal circulation device). A heart-lung machine is a device that substitutes the respiratory function of the lungs by performing blood circulation to organs throughout the body instead of the heart while the pump function of the heart is stopped, and simultaneously exchanging blood gas , Blood pump, oxygenator (artificial lung), heat exchanger, and blood reservoir. The cardiopulmonary apparatus is mainly used for extracorporeal circulation as an auxiliary means of open heart surgery, and the pump function of the heart is remarkably deteriorated, so that the replenishment circulation when the organ / tissue falls into circulatory failure, and the gas exchange capacity of the lung is high. It is widely used to assist lung function when affected, as well as to assist with extracorporeal circulation (ECMO) and thoracic aortic aneurysm surgery.

Until the first successful operation with an artificial heart-lung machine by Gibbon in 1953, the beating heart operation was performed blindly because of circulating blood and may be very unsafe. After that, various artificial heart-lung machines and myocardial protective fluids have been improved, and safe surgery can be performed.
However, even now, the following complications have occurred after surgery using the heart-lung machine, and the elimination of these complications remains a problem.
(1) Cerebral complications: cerebral hypoxemia and cerebral edema due to inappropriate perfusion. Cerebral infarction due to the inhalation of the inhalation into the extracorporeal circuit in the cardiopulmonary bypass device or the release of tissue fragments into the blood caused by the operation of attaching the cardiopulmonary bypass device to the patient.
(2) Pulmonary complications: hypoxemia caused by various inflammatory substances activated by the cardiopulmonary apparatus, ventilation failure.
(3) Renal dysfunction: acute renal failure due to a decrease in renal blood flow by an oxygenator.
(4) Blood destruction: Blood is destroyed by perfusing blood into an artificial heart lung machine. This may cause impaired renal function and require blood transfusion.
(5) Postoperative hemorrhage: Postoperative hemorrhage may occur due to in vivo hemostasis failure by the cardiopulmonary apparatus.
(6) Aortic dissection: When a blood vessel used for blood transmission is inserted into the aorta, there is a possibility that the vascular endothelium is damaged to cause acute arterial dissection. This complication is very severe and the patient's mortality rate is high.
(7) Other complications: Onset of postoperative infections associated with a decrease in the biological immune response, multiple organ failure, etc.

These complications often result in systemic inflammation, even if not severe, and the hospitalization period after surgery requires a minimum of one week. In addition, since the artificial circulation path used in surgery is disposable, high medical costs are a problem.
On the other hand, recently, movements to avoid the side effects associated with the use of the above-mentioned cardiopulmonary apparatus have been seen in the area of coronary artery bypass surgery, and there is a surgical method that does not use an artificial cardiopulmonary apparatus. It is spreading rapidly. In particular, low-invasive surgery using an endoscope has been widely performed, attracting attention as a method with low occurrence of complications and quick recovery after surgery.

  Although there is a growing demand to perform surgery without using a heart-lung machine inside the heart, it is actually impossible to stop the heart beat. In addition, it has been pointed out that it is difficult to apply an endoscope because a visual field cannot be secured due to the presence of blood. Although catheter devices such as Amplatzer (trade name) and Angelwing (trade name) have been applied to atrial septal defects, etc., internal heart defects differ from case to case, and target uniform defects. However, these devices still have a problem that they cannot be adequately addressed. For these reasons, there has been a demand for a breakthrough for realizing a surgery that does not use a heart-lung machine.

  The present invention has been made in view of the above circumstances, and an object thereof is to provide means for performing minimally invasive surgery on a defect inside the heart without using a heart-lung machine.

In order to solve the above-mentioned problems, the present inventors have devised a method for surgically incising the chest and inserting a suturing device through the sheath, and have reached the present invention. That is, the present invention includes a first shaft having a lumen penetrating from the distal end to the proximal end, first suture needle gripping means provided on the distal end of the first shaft at a predetermined length from the coaxial distal end, A first shaft member comprising a connector with a hemostasis valve provided at the base end of one shaft; a lumen having a lumen penetrating from the distal end to the base end and slidably inserted into the first shaft member A second shaft member, and a second shaft member including a connector with a hemostasis valve provided at a proximal end of the second shaft; and slidably inserted into the second shaft member A third shaft member comprising a hollow third shaft and an operating portion provided at the base end of the third shaft; and being housed and disposed at the tip of the third shaft; Possible second suture needle gripping means A puncture member provided at the proximal end thereof and having a hollow operation rod at the proximal end connected to the proximal end of the second suture needle gripping means and inserted into the third shaft member so as to be movable forward and backward; The second shaft protrudes from the tip of the first shaft and is slidable in the direction of the first suturing needle gripping means, and slides into and stores the affected tissue in the notch The affected tissue can be sandwiched, and the second shaft is slid to a position where the suture site is sandwiched with the first suture needle gripping means, and the third shaft is moved to the tip of the slid second shaft. When the shaft of the first suturing needle is slid, the suturing needle can be transferred between the first suturing needle gripping means and the second suturing needle gripping means, and the first suturing needle can be transferred from the first suturing needle gripping means. Deliver the suture needle to the gripping means In the process, the affected part tissue pinched by the notch is punctured, and the first shaft member is advanced while the suture needle is held by the first suture needle gripping means, and the suture needle is moved to the affected part. An intracardiac suturing device is characterized in that it is configured to penetrate tissue.

  Here, the second suture needle grasping means has a proximal end side having an outer diameter smaller than the inner diameter of the third shaft, and a distal end having an outer diameter larger than the inner diameter of the third shaft and tapering in the proximal direction. An operating rod comprising a flexible hollow member having an inner diameter slightly larger than that of a suture needle and having a plurality of longitudinal slits provided on the distal end side including the expanded portion. When the bulging portion is stored in the third shaft by operating, the inner diameter of the bulging portion may be compressed and the suture needle may be gripped. In this case, an annular protrusion is provided at the distal end portion of the lumen of the third shaft so that when the bulging portion is accommodated in the third shaft, the movement of the bulging portion in the proximal direction is prevented. Further, a flange is provided at the base end of the hollow member, and a coil spring is accommodated and disposed so as to wind the hollow member between the flange and the annular projection, and an operation rod advanced by an operation accompanied by compression of the coil spring is provided. Further, it may be automatically retracted by the elastic force of the coil spring. Furthermore, in order to improve the operability of the second suture needle gripping means, a grip portion may be provided at the proximal end of the operation rod, and the grip portion may be movable forward and backward with respect to the operation portion.

The first suturing needle gripping means includes a flexible hollow member in which a portion for gripping the suturing needle has an inner diameter slightly smaller than the suturing needle, and the suturing needle is inserted on the first shaft side of the hollow member. The opening may be provided, and a plurality of slits may be provided in the longitudinal direction of the hollow member, and the first suturing needle grasping means has a portion that grasps the suturing needle slightly more than the suturing needle. A flexible hollow member having a large inner diameter and having a bulge formed at the distal end, a hollow pressing member provided on the distal end side of the hollow member so as to surround the bulged portion, and a proximal end side from the pressing member A coil spring that is housed and disposed so as to wind the hollow member. The hollow member is provided with a plurality of slits in the longitudinal direction, and the pressing member compresses the hollow member from the first position. To the second position to release It is comprised been rotatably be.
The intracardiac suturing device may be attached with visual means such as an endoscope or an ultrasonic probe for confirming the position in the heart, and the connector of the first shaft member or the second The connector of the shaft member may be provided with a side injection tube for injecting heparin, physiological saline for washing, or the like.

If the intracardiac suture device of the present invention is employed, minimally invasive surgery can be performed on a defect inside the heart without using an artificial heart-lung machine.
And according to this invention, compared with the operation using the conventional heart-lung machine, a safer and more reliable operation can be performed and cost reduction is possible. Furthermore, since the post-operative recovery time, which conventionally took more than one week, can be shortened to about one day, there is very little concern about complications. In addition, the operation of the apparatus is easy and the burden on the operator is reduced.

Next, embodiments of the present invention will be described with reference to the drawings.
1 is a plan view of an intracardiac suturing device according to an embodiment of the present invention, FIGS. 2 and 3 are plan views showing another embodiment of the present invention, and FIG. 4 is a line AA ′ in FIG. 5 is a longitudinal sectional view of a proximal end portion in FIG. 1, FIG. 6 is a longitudinal sectional view of a distal end portion including first and second suture needle gripping portions in FIG. 1, and FIG. 7 is a first suture needle. It is a longitudinal cross-sectional view of the front-end | tip part containing the other Example of a holding part. 8 to 15 are explanatory views of the suturing operation using the intracardiac suturing device of the present invention.
As shown in FIGS. 1 to 7, the intracardiac suture device of the present invention includes a first shaft member 1 including a first shaft 11 and a first suture needle grasping means 4 at the tip, and the first shaft. A second shaft member 2 including a second shaft 21 slidably attached to the member 1, a hollow third shaft 31 slidably attached to the second shaft member 2, and the first shaft 21. A third shaft member 3 including an operating portion provided at the proximal end of the third shaft, and a second suture needle gripping means 51 which is housed and disposed at the distal end of the third shaft 31 and which can be inserted and removed from the distal end. The second shaft 21 is slidable in the direction of the first suture needle gripping means 4 so as to protrude from the distal end of the first shaft 11, and the second shaft 21. 21 to the first suture needle gripping means 4 When the third shaft 31 is slid to the tip of the slid second shaft 21, the first suture needle grasping means 4 and the second suture needle grasping means are slid to the position where the sutured portion is sandwiched. The suturing needle 6 can be delivered between 51.

As shown in FIGS. 6 and 7, the first shaft member 1 includes a first shaft 11 having a lumen 111 penetrating from the distal end to the proximal end, and a predetermined coaxially distal end to the distal end of the first shaft 11. A first suture needle gripping means 4 provided at a long distance and a connector 12 with a hemostasis valve provided at the proximal end of the first shaft 11 are included.
The first shaft 11 is formed of a metal such as stainless steel or brass, a meshed or coiled stainless steel, a fluororesin (such as polytetrafluoroethylene), or a synthetic resin such as polypropylene, polyethylene, polyamide, polyethylene terephthalate, or polyurethane. The second shaft member 2 inserted from the connector 12 provided at the proximal end is slidably attached to the lumen 111 provided through the proximal end from the distal end thereof. (To be precise, the second shaft 21 is inserted).
The connector 12 is generally a tubular member formed of a synthetic resin such as polypropylene, ABS resin, polyvinyl chloride, polyethylene, polyethylene terephthalate, or a metal such as stainless steel or brass, and has a second shaft 21 at the base end. The insertion port 121 is formed, and hemostatic means (not shown) is provided in the inside so that blood does not leak during the operation.

The first suture needle grasping means 4 may be accommodated in a grasping means accommodating portion 13 formed integrally with a tube forming the first shaft 11. In this case, for example, as shown in FIGS. 1 to 3, the gripping means accommodating portion 13 is formed at the tip of the tube forming the first shaft 11, and between the tip of the first shaft 11, a predetermined amount is formed. A cutout 14 is provided having a length that is sufficiently greater than the radius of the first shaft 11. The distal end of the grasping means accommodating portion 13 is closed, and the first suture needle grasping means 4 is fixed to the closing member 46.
The first suturing needle grasping means 4 is arranged in the grasping means accommodating portion 13 so that the tip thereof faces the first shaft 11 side. For example, a portion for grasping the suturing needle 6 as shown in FIG. Includes a flexible hollow member 41 having an inner diameter slightly smaller than that of the suturing needle 6. What is provided with the slit 411 is employ | adopted. The first suturing needle gripping means 4 has a flexibility as shown in FIG. 7 in which a portion for gripping the suturing needle 6 has an inner diameter slightly larger than that of the suturing needle 6 and a bulging portion 432 is formed at the tip. The hollow member 43 with the slit 431, the hollow pressing member 44 provided so as to surround the bulging portion 432 on the distal end side of the hollow member 43, and the hollow member 43 wound around the proximal end side from the pressing member 44 are accommodated. The coil spring 45 arranged may be included. In this case, a plurality of slits 431 of the hollow member 43 are provided in the longitudinal direction including the expanded portion 432. The pressing member 44 has an inner diameter on the proximal end side that is slightly larger than an outer diameter on the proximal end side of the hollow member 43, the inner diameter is increased in a tapered shape on the distal end side, and the inner diameter on the distal end side is that of the expanded portion 432. The outer diameter is larger than the outer diameter and slightly smaller than the inner diameter of the gripping means accommodating portion 13, and is accommodated in the gripping means accommodating portion 13 together with the first gripping means 4. Then, the pressing member 44 moves from the first position (first position) where the hollow member 43 is compressed to the second position where the compression is released (the coil spring 45 is compressed and moved toward the proximal end of the gripping means accommodating portion 13). The outer wall of the bulging portion 432 and the inner wall of the pressing member 44 can be moved to a position where they do not contact each other.

  As the material for forming the first suture needle gripping means 4, for the hollow members 41 and 43, metals such as stainless steel and brass, flexible resins such as polypropylene, polyethylene, and polyamide can be used. The suture needle insertion port 42 is made of a fluororesin (polytetrafluoroethylene or the like) or a synthetic resin such as polypropylene, polyethylene, polyamide, polyethylene terephthalate, or polyurethane, and the pressing member 44 is made of the same material as the hollow members 41 and 43. It can be adopted.

As shown in FIGS. 6 and 7, the second shaft member 2 includes a second shaft 21 having a lumen 211 penetrating from the distal end to the proximal end, and a hemostasis valve provided at the proximal end of the second shaft. And a slidable member in the direction of the first suturing needle gripping means 4. The second shaft member 2 is a tubular member made of the same material as that of the first shaft member 1, and the lumen 211 provided so as to penetrate from the distal end to the proximal end is provided at the proximal end. The third shaft member 3 inserted from the connector 22 is slidably inserted (more precisely, the third shaft 31 is inserted).
The connector 22 is a tubular member made of the same material as that of the connector 12, and an insertion port 221 of the third shaft 311 is formed at the proximal end so that blood does not leak during the operation. Is provided with hemostatic means (not shown).

The third shaft member 3 includes a hollow third shaft 31 and an operation portion 33 provided at the base end of the third shaft.
The third shaft 31 is a tubular member formed of the same material as that of the first shaft 11, and a lumen 311 is provided from the distal end to the proximal end. An operation portion 33 is provided at the proximal end of the third shaft 31 to slide it forward and backward, and an operation rod 52 of the second suture needle gripping means 5 described later is advanced and retracted from the operation portion 33. It is inserted movably. The material for forming the operation part is not particularly limited, but generally the same material as the third shaft 31 is employed.

  The puncture member 5 is inserted into the third shaft member 3 so as to be able to move forward and backward, and has a second suture needle gripping means 51 at the distal end, and a base end of the second suture needle gripping means 51 at the proximal end. A hollow operating rod 52 connected to the end is provided. The second suture needle gripping means 51 is housed and arranged at the distal end of the third shaft 31 and can be inserted and removed from the distal end. The operation rod 52 is inserted into the lumen 311 of the third shaft 31 so as to be able to advance and retract. It is worn. The second suturing needle gripping means 51 includes a flexible hollow member 55 having an inner diameter slightly larger than that of the suturing needle 6, and this hollow member 55 has an outer side whose proximal end is smaller than the inner diameter of the third shaft 31. It has a diameter. A bulging portion 552 having an outer diameter larger than the inner diameter of the third shaft 31 and having a tapered diameter in the proximal direction is provided at the distal end of the hollow member 55, and a longitudinal direction is provided on the distal end side including the bulging portion 552. A plurality of slits 551 are provided. A hollow operation rod 52 slidably inserted into the lumen 311 of the third shaft 31 is connected to the proximal end of the hollow member 55, and the bulging portion 552 is connected to the inside of the third shaft 31. When the needle is housed, the inner diameter of the bulging portion 552 is compressed and the suture needle 6 is gripped. In this case, as shown in FIGS. 6 and 7, when the annular protrusion 312 is provided at the distal end portion of the lumen 311 of the third shaft 31, and the expanded portion 552 is accommodated in the third shaft 31, the expanded portion 552. It is preferable that the movement in the proximal direction is prevented. The bulging portion 552 may be accommodated in the third shaft 31 by operating the operating rod 52 by hand or the like. For example, as shown in FIGS. The coil spring 53 is accommodated and disposed so that the hollow member 55 is wound between the flange 553 and the annular projection 312, and the operation rod 52 advanced by an operation accompanied by compression of the coil spring 53 is provided with the elastic force of the coil spring 53. The expansion portion 552 may be accommodated in the third shaft 31 by automatically retreating by the generated force. Further, in order to improve the operability of the second suture needle gripping means 51, an operation portion 54 is provided at the proximal end of the operation rod 52, and this operation portion 54 is moved forward and backward with respect to the operation portion 33 of the third shaft member 3. It may be possible.

In such a combination of the first, second, and third shaft members 1, 2, and 3 and the puncture member 5, the second shaft 21 protrudes from the tip of the first shaft 1 and the first stitching is performed. The second shaft 21 can be slid in the direction of the needle gripping means 4, and the second shaft 21 is slid to a position where the suture site is sandwiched between the first suture needle gripping means 4 and the second shaft 21 thus slid. When the third shaft 31 is slid to the tip, the suture needle 6 can be delivered between the first suture needle gripping means 4 and the second suture needle gripping means 51.
As shown in FIG. 3, the intracardiac suture device of the present invention is attached with visual means such as an endoscope 8 or an ultrasonic probe (not shown) for confirming the position in the heart. Also, as shown in FIG. 2, the connector 12 (not shown) of the first shaft member 1 or the connector 22 of the second shaft member 2 may have heparin, physiological saline for washing, etc. A side injection tube 222 may be provided for injecting.
The material for forming the hollow member 55 of the second suture needle gripping means 51 is the same as that of the hollow member 43 of the first suture needle gripping means 4 in terms of structure and function. Of course, the same material as the material for forming the hollow member 43 of the first suture needle gripping means 4 is adopted, though not necessarily.

  Next, the defect closure operation performed using the intracardiac suture device of the present invention will be described with reference to FIGS. First, the chest is incised surgically to confirm the heart. Next, a hole is made in a part of the heart (usually the right atrial appendage), and an intracardiac suture device insertion sheath (not shown) is inserted through this hole to the vicinity of the target site. Subsequently, an intracardiac suturing device as shown in FIG. 1 (the relationship between the third shaft 31 and the second suturing needle grasping means 51 is as shown in FIGS. 5 and 6) is inserted into the sheath, Guide to the target area. Next, as shown in FIG. 8, the distal end portion protrudes from the sheath, the first suture needle gripping means 4 portion is inserted into the defect hole DA in the heart, and the defect hole DA is positioned at the notch 14 portion. To do. Next, if necessary, while confirming the positional relationship in the heart with visual means such as the endoscope 8, the second shaft member 2 is pushed in by hand to advance with respect to the first shaft member 1, and the gripping means accommodating portion 13 and the tip of the second shaft 21 sandwich the tissue T around the defect hole DA. At this time, the third shaft member 3 moves forward together with the second shaft member 2 (FIG. 9). Next, with the tissue T sandwiched between the grasping means accommodating portion 13 and the second shaft 21, the operating portion 33 is pushed by hand to advance the third shaft member 3 with respect to the second shaft member 2. . Then, the second suture needle gripping means 51 accommodated in the third shaft 31 also advances together with the third shaft 31 to puncture the tissue T, and the distal end portion of the suture needle 6 is the first suture needle. It is inserted into the gripping means 4 and gripped (FIG. 10). Next, when the operation unit 33 is retracted with respect to the operation unit 54 of the puncture member 5, the expanded portion 552 comes out of the third shaft 31 and the compression of the hollow member 55 by the third shaft 31 is released. Therefore, the inner diameter of the hollow member 55 becomes larger than the outer diameter of the suture needle 6, and the suture needle 6 is released from the second suture needle gripping means 51 (FIG. 11). At this time, the coil spring 53 is compressed. In this state, when the first shaft member 1 is pushed in by hand to advance with respect to the second shaft member, and the suture needle 6 is moved out of the second suture needle gripping means 51 with respect to the tissue T, the suture needle 6 is It passes to the 1st suture needle holding means 4, and will be in a state like FIG.

  Next, when the entire intracardiac suturing device is slightly retracted and the hand is released from the operating portion 54 of the puncture member 5 while the operating portion 33 is gripped by hand, the second suturing needle gripping means is generated by the elastic force of the coil spring 53. 51 is retracted, and the bulging portion 552 is accommodated in the third shaft 31. When the entire intracardiac suturing apparatus is moved in this state and the tissue T is moved out of the notch 14, the state shown in FIG. 13 is obtained. In this state, when the second shaft member 2 is pushed by hand to advance to substantially the same position as in FIG. 9 with respect to the first shaft member 1, and the operation portion 33 is further retracted relative to the operation portion 54 of the puncture member 5. The expanded portion 552 comes out of the third shaft 31 and the compression of the hollow member 55 by the third shaft 31 is released, so that the inner diameter of the hollow member 55 becomes larger than the outer diameter of the suture needle 6. When the third shaft member 3 is advanced with respect to the second shaft member 2 by pushing the operating portion 33 by hand in this state, the suture needle 6 is accommodated in the second suture needle gripping means 51 (FIG. 14). . At this time, the coil spring 53 is compressed. Next, when the operation part 54 of the puncture member 5 and the second shaft member 2 are gripped by hand, when the hand is released from the operation part 33, the third shaft member 3 moves forward by the elastic force of the coil spring 53, Since the bulging portion 552 is accommodated in the third shaft 31, the hollow member 55 is compressed by the third shaft 31, and the inner diameter of the hollow member 55 becomes smaller than the outer diameter of the suture needle 6. It is gripped by the second suture needle gripping means 51. In this state, when the first shaft member 1 is pushed by hand and advanced with respect to the second shaft member 2, the suture needle 6 is transferred to the second suture needle gripping means 51, and the state shown in FIG. 15 is obtained. Become. This operation is repeated several times, and the defect closure is completed by ligating and cutting the suture using a dedicated instrument.

1 is a plan view of an intracardiac suturing device according to an embodiment of the present invention. It is a top view which shows the other Example of this invention. It is a top view which shows other Example of this invention. FIG. 2 is a cross-sectional view taken along line A-A ′ of FIG. 1. FIG. 5 is a longitudinal sectional view of the base end portion in FIG. It is a longitudinal cross-sectional view of the front-end | tip part containing the 1st and 2nd suture needle holding part in FIG. It is a longitudinal cross-sectional view of the front-end | tip part containing the other Example of the 1st suture needle holding part. It is explanatory drawing of the suturing operation using the intracardiac suturing apparatus of this invention. It is explanatory drawing of the suturing operation using the intracardiac suturing apparatus of this invention. It is explanatory drawing of the suturing operation using the intracardiac suturing apparatus of this invention. It is explanatory drawing of the suturing operation using the intracardiac suturing apparatus of this invention. It is explanatory drawing of the suturing operation using the intracardiac suturing apparatus of this invention. It is explanatory drawing of the suturing operation using the intracardiac suturing apparatus of this invention. It is explanatory drawing of the suturing operation using the intracardiac suturing apparatus of this invention. It is explanatory drawing of the suturing operation using the intracardiac suturing apparatus of this invention.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 1st shaft member 11 1st shaft 111 Lumen 12 Connector 13 Holding means accommodating part 14 Notch 2 2nd shaft member 21 2nd shaft 211 Lumen 22 Connector 3 3rd shaft member 31 3rd shaft 311 Lumen 312 Annular projection 33 Operating portion 4 First suture needle gripping means 41 Hollow member 411 Slit 42 Suture needle insertion port 43 Hollow member 431 Slit 432 Swelling portion 44 Pressing member 45 Coil spring 46 Closure member 5 Puncture member 51 Second suture needle Grasping means 52 Operation rod 53 Coil spring 54 Operation part 55 Hollow member 551 Slit 552 Swelling part 553 Flange 6 Suture needle 7 Suture thread 8 Endoscope DA Deficient hole T Tissue

Claims (9)

A first shaft having a lumen penetrating from the distal end to the proximal end; first suture needle gripping means provided on the distal end of the first shaft at a predetermined distance from the coaxial distal end; and a base of the first shaft A first shaft member comprising a connector with a hemostasis valve provided at the end; a second shaft having a lumen penetrating from the distal end to the proximal end and slidably inserted into the first shaft member A second shaft member including a shaft and a connector with a hemostasis valve provided at a proximal end of the second shaft; and a hollow third member slidably inserted into the second shaft member A third shaft member including an operating portion provided at a proximal end of the third shaft; a second shaft member housed and disposed at a distal end of the third shaft; A suture needle gripping means is provided at the tip, A piercing member provided at the base end thereof with a hollow operating rod connected to the base end of the second suture needle gripping means and inserted into the third shaft member so as to be able to advance and retreat. The shaft protrudes from the tip of the first shaft and can be slid in the direction of the first suture needle gripping means, and can slide to store the affected tissue in the notch and sandwich the stored affected tissue. age,
When the second shaft is slid to a position where a suture site is sandwiched between the first suture needle gripping means and the third shaft is slid to the tip of the slid second shaft. Enabling the delivery of the suture needle between the first suture needle gripping means and the second suture needle gripping means ;
In the process of delivering the suture needle from the first suture needle grasping means to the first suture needle grasping means, the suture needle is punctured into the affected tissue sandwiched by the notch, and the first suture needle grasping means An intracardiac suturing device , wherein the first shaft member is advanced while the suturing needle is gripped to penetrate the affected tissue . The second suture needle gripping means has a proximal end having an outer diameter smaller than the inner diameter of the third shaft, a distal end having an outer diameter larger than the inner diameter of the third shaft, and a tapered diameter in the proximal direction. A flexible hollow member having a slightly larger inner diameter than the suture needle and provided with a plurality of longitudinal slits on the distal end side including the bulged portion, and operating the operating rod. The intracardiac suturing device according to claim 1, wherein when the bulging portion is housed in the third shaft, the inner diameter of the bulging portion is compressed and the suture needle is gripped. An annular protrusion is provided at the distal end portion of the lumen of the third shaft, and when the expanded portion is accommodated in the third shaft, movement of the expanded portion in the proximal direction is prevented. An intracardiac suturing device according to claim 1. A flange is provided at the proximal end of the hollow member, and a coil spring is accommodated and disposed so that the hollow member is wound between the flange and the annular projection, and an operation rod that is advanced by an operation accompanied by compression of the coil spring is provided with a resilient spring of the coil spring. The intracardiac suturing device according to claim 3, wherein the device is automatically retracted by force. The intracardiac suturing device according to any one of claims 2 to 4, wherein an operating portion is provided at a proximal end of the operating rod, and the operating portion is movable forward and backward with respect to the operating portion of the third shaft member. The first suturing needle grasping means includes a flexible hollow member in which a portion for grasping the suturing needle is formed with an inner diameter slightly smaller than the suturing needle, and a suturing needle insertion port is provided at the tip of the hollow member. In addition, the intracardiac suture device according to any one of claims 1 to 5, wherein a plurality of slits are provided in the longitudinal direction of the hollow member. The first suturing needle gripping means includes a flexible hollow member having a slightly larger inner diameter than that of the suturing needle and a bulging portion formed at the tip thereof, and the bulging portion on the tip side of the hollow member. A hollow pressing member provided so as to surround the portion, and a coil spring housed and disposed so as to wind the hollow member on the proximal side from the pressing member, and the hollow member has a plurality of slits in the longitudinal direction. The intracardiac suturing device according to any one of claims 1 to 5, wherein the intracardiac suture device is provided and is movable from a first position for compressing the hollow member to a second position for releasing the compression. . The intracardiac suturing device according to claim 6 or 7, wherein a visual means for confirming a position in the heart is attached. The intracardiac suture device according to any one of claims 1 to 8, wherein a side injection tube for injecting physiological saline, heparin, or the like is provided in the connector of the first shaft member or the connector of the second shaft member.

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