The present invention relates to an atrial-appendage ligation surgical tool and to an atrial appendage ligation system.
The population of patients with atrial fibrillation, which is one form of cardiac arrhythmia has shown an increasing tendency in recent years. Strokes triggered by atrial fibrillation are thought to occur because a cerebral vessel becomes blocked with a thrombus that originated in the heart (mostly in a left atrial appendage). The most frequent embolic source of cardioembolic stroke is the left atrial appendage thrombus.
A therapy commonly recommended for prevention of cardioembolic stroke is anticoagulation treatment with warfarin; however, medication management of warfarin is difficult, and there is a risk of hemorrhagic complications. As a substitute therefor, a method for preventing embolisms by closure of the left atrial appendage has been developed (for example, Watchman produced by Boston Scientific). This method uses a jellyfish-shaped device that closes the left atrial appendage transvascular manner.
There is a known surgical tool that ligates an atrial appendage from outside the heart without the use of an anticoagulant or the use of transvascular procedures (for example, refer to Patent Literature 1). This is a surgical tool with which forceps and a ligation loop are inserted into a pericardium from outside the body, the ligation loop is put around the atrial appendage while the tip of the atrial appendage is being retained and pulled by the retention forceps, and then the ligation loop is tightened to ligate the atrial appendage.
This surgical tool is equipped with a sleeve that accommodates the ligation loop in a recessed portion of the sleeve. The sleeve keeps the ligation loop wide open so that the endoloop can be easily put around the atrial appendage.
US Patent Application Publication No. 2008/0294175 specification
When atrial appendage ligation operation is performed with this surgical tool, just pulling the tip of an atrial appendage by retention forceps causes the outer wall of the left atrium to deform and move in the pulling direction together with the atrial appendage; accordingly, there is a possibility that the base of the atrial appendage, where it is desired to perform ligation, cannot be exposed.
The present invention is an atrial-appendage ligation surgical tool and an atrial appendage ligation system that facilitate ligation in the vicinity of the base of an atrial appendage with a ligation loop.
One aspect of the present invention provides at least one atrial-appendage ligation surgical tool. The surgical tool includes a pressing part that is guided into a pericardium via a sheath penetrating through a pericardial membrane, and that includes a contact portion that presses a vicinity of a base of an atrial appendage; and a shaft that is disposed in an inserted state in the sheath and supports the pressing part at a distal end.
According to this aspect, at least one atrial-appendage ligation surgical tool is guided into the pericardium via a sheath penetrating through the pericardial membrane, and the pressing part in the pericardium can be advanced toward the atrial appendage by pushing the shaft in the longitudinal direction at the proximal side of the sheath. As a result, the distal end is placed in the vicinity of the atrial appendage, for example, under the atrial appendage. At this stage, an observation means such as an endoscope may be separately inserted and placed by using an X-ray fluoroscopic image.
Another aspect of the present invention provides an atrial-appendage ligation surgical tool that includes a pressing part that is guided into a pericardium via a sheath penetrating through a pericardial membrane, and that includes two bar-shaped contact portions that can be arranged along a width direction of the atrial appendage and at a position where the atrial appendage is pinched in a thickness direction; a shaft that is disposed in an inserted state in the sheath and that supports the pressing part at a distal end; and a biasing means for biasing the pressing part so that the pressing part is arranged in lined manner with respect to the shaft when the pressing part is inside the sheath and the pressing part extends in a direction intersecting a longitudinal axis of the shaft when the pressing part is released from the sheath.
According to this aspect, as the atrial-appendage ligation surgical tool is guided into the pericardium via the sheath penetrating through the pericardial membrane, the pressing part arranged in lined manner with respect to the shaft within the sheath is biased so that the pressing part is made to extend in a direction intersecting the longitudinal axis of the shaft by the biasing means as soon as the pressing part is released from the sheath and is in the pericardium. In this state, the pressing part is made to advance toward the atrial appendage in the pericardium by pressing the shaft in the longitudinal direction from the proximal end side of the sheath.
In the above-described aspect, the contact portions may be configured so that a spacing therebetween is changeable.
In the above-described aspect, the contact portions may be rollers that rotatable about their longitudinal axes.
In the above-described aspect, the shaft may be made of an elastic material and has a pre-bent section to constitute the biasing means.
In the aspect described above, one of the contact portions may include a magnetic material and the other contact portion may include a magnet.
In the aspect described above, the two contact portions may have retention portions that releasably retain a ligation loop guided along the shaft.
In the aspect described above, a retention portion that releasably retains a ligation loop may be provided so as to be movable along the shaft.
Another aspect of the present invention provides an atrial appendage ligation system that includes retention forceps that retain an atrial appendage and the atrial-appendage ligation surgical tool described above.
A surgical tool 1 for atrial appendage ligation according to one embodiment of the present invention will now be described with reference to the drawings.
As shown in
The pressing part 3 includes two straight-rod-shaped contact portions 4 arranged to be parallel to each other with a particular interval therebetween, and has a bifurcated shape. The plane of a curve formed by the pre-bent section of the shaft 2 is substantially orthogonal to the plane in which the two contact portions 4 lie.
The shaft 2 can bend to follow the shape of a sheath 5, but has rigidity that enables transmission of a pressing force acting in the longitudinal direction, applied from the proximal end of the sheath 5. As shown in
As shown in
The spacing between the contact portions 4 is set to a value such that an atrial appendage A can be pinched by these two portions in the thickness direction.
The procedure for ligating the atrial appendage A by using the surgical tool 1 for atrial appendage ligation according to this embodiment, having the above-described configuration, is described below.
In order to ligate the atrial appendage A by using the surgical tool 1 for atrial appendage ligation according to this embodiment, first, a distal end opening of the sheath 5 is moved to the interior of the pericardium from the lower portion of the xiphoid process and by penetrating through the body surface tissue and the pericardial membrane. While this state is maintained, the surgical tool 1 for atrial appendage ligation having the pre-bent section of the shaft 2 substantially straightened is inserted into the sheath 5 and is made to advance toward the pericardium.
At this stage, the pressing part 3 is substantially in line with the shaft 2 and thus can advance smoothly inside the sheath 5. Once the pressing part 3 is delivered to the interior of the pericardium from the distal end opening of the sheath 5, the pre-bent section of the shaft 2, which has been restricted, is released and a bend is formed, as shown in
Under such conditions, the shaft 3 is operated from the proximal end of the sheath 5, which is outside the body, while conducting observation with an endoscope, which has been separately inserted into the pericardium, so that, as shown in
As shown in
While this state is maintained, a shaft (hereinafter referred to as a loop shaft) 7 of a ligation loop 6, which has been made to approach the atrial appendage from the outer side of the retention forceps (not shown), and the retention forceps are operated simultaneously so as to put the ligation loop 6 around the atrial appendage A.
In other words, while retaining the tip of the atrial appendage A with the retention forceps, the retention forceps are pulled, and the loop shaft 7 is pushed out simultaneously so that the retention forceps retaining the atrial appendage A are removed from the inside of the ligation loop 6. As a result, as shown in
As shown in
In such a case, since the pressing part 3 of the surgical tool 1 for atrial appendage ligation is located near the position where ligation of the atrial appendage A is desirably performed, and causes the atrial appendage A to be indented in the thickness direction, tightening of the ligation loop 6 does not cause the ligation loop 6 to come off and move toward the tip of the atrial appendage A. Thus, the ligation site can be maintained.
That is, when the tip of the atrial appendage A is pulled by the retention forceps without using the surgical tool 1 for atrial appendage ligation, the outer wall of the left atrium is pulled together with the atrial appendage A. Accordingly, the atrial appendage A does not stretch enough, and the base of the atrial appendage A where ligation is desirably performed remains unexposed. In contrast, according to this embodiment, as shown in
After the atrial appendage A is ligated, the loop shaft 7 is pulled out while leaving the ligation loop 6 at the site, and cutting forceps, which have been guided via the sheath 5, cut the ligation loop 6 at a portion near the knot.
Subsequently, the shaft 2 of the surgical tool 1 for atrial appendage ligation is moved in a direction that enables the shaft 2 to be pulled out from the sheath, and the pressing part 3 is removed from the atrial appendage A. As the pressing part 3 is withdrawn into the sheath 5, the pre-bent section is straightened, and the pressing part 3 is removed from the body via the sheath 5.
The state of the ligated atrial appendage A is confirmed with an endoscope by moving the atrial appendage A retained by the retention forceps. If satisfactory ligation is confirmed, all surgical tools are pulled out, thus ending the procedure.
In this embodiment, the pressing part 3 having two straight-rod-shaped contact portions parallel to each other with a particular gap therebetween is described as an example. However, the invention is not limited to this structure, and any of the following forms shown in
Although the pressing part 3 in which two contact portions 4 are fixed at positions that are separated from each other by a particular spacing has been described, it is possible to use an alternative, such as the one shown in
According to this structure, the contact portions 4 can be brought close to each other to save space as the contact portions 4 pass via the sheath 5. In inserting the atrial appendage A, the spacing between the two contact portions can be widened to facilitate insertion. After the insertion, the two contact portions 4 can be again brought close to each other so as to pinch the atrial appendage A in the thickness direction so that the outer wall of the left atrium can be pressed while constricting the atrial appendage A.
The mechanism for opening and closing the two contact portions 4 may be a wire (not shown) that has been guided along the shaft 2 and that is configured to open and close the contact portions 4, as with typical retention forceps. Alternatively, as shown in
Two contact portions 4 may both be equipped with electromagnets 9. When two contact portions 4 are respectively guided via different shafts 2, permanent magnets may be employed instead of the electromagnets 9.
In this embodiment, the pre-bent section of the shaft 2 is straightened by the sheath 5. Alternatively, as shown in
This embodiment is configured so that, by using the shaft 2, which is made of an elastic material and has a pre-bent section, the pressing part 3 in the pericardium is arranged to lie in a direction intersecting the longitudinal direction of the shaft 2. Alternatively, as shown in
As shown by chain lines in
As shown in
Although the contact portions 4 have been described as having a simple bar shape as an example, contact portions 4 formed of rollers rotatable about the longitudinal axes may be employed instead, as shown in
In this embodiment, the surgical tool 1 for atrial appendage ligation has been described as being a separate tool from the litigation loop 6. Alternatively, as shown in
In the example shown in
As shown in
As shown in
In this case, when the ligation loop 6 is put, by using the loop shaft 7, around the atrial appendage A to which the shaft 2 is fixed by being pinched by the contact portions 4 of the surgical tool 1 for atrial appendage ligation, the ligation loop 6 can be moved by using the retention member 13 while maintaining a wide open state. Although the atrial appendage A changes in position due to pulsation, the shaft 2 fixed to the atrial appendage A moves together with the atrial appendage A. Thus, the ligation loop 6 can be stably put around the atrial appendage A, along the rail 12 of the shaft 2.
As shown in
In other words, while the shaft 2 is pushed forward to press the base of the atrial appendage A with the pressing part 3 of the surgical tool 1 for atrial appendage ligation, the tip of the atrial appendage A pinched by the retention forceps 14 is pulled toward the proximal side so as to stretch the atrial appendage A and expose the base so that the ligation loop 6 can be easily placed therearound. Accordingly, the operation of the surgical tool 1 for atrial appendage ligation and the operation of the retention forceps 14 occur on the same straight line, and since they are installed to be relatively movable, ease-of-operation can be improved.
In this case, a forceps shaft 16, which supports the retention forceps 14, may have a pre-bent section so that the forceps shaft 16 is configured to deform in a direction slightly away from the shaft 2 of the surgical tool 1 for atrial appendage ligation when it is protruded forward from the sheath 5. This is because these shafts are arranged closed to each other within the sheath 5, but the tip of the atrial appendage A can be more easily retained if the shafts are slightly distant from each other.
In this case, as shown in
The pressing tool 3 may be configured to immediately move toward the proximal end side as soon as a hemodynamic abnormality (ventricular fibrillation or atrial fibrillation) is detected from the waveform of the electrocardiograph. According to this configuration, it becomes possible not to apply excessive pressure to the left atrium by the pressing tool 3.
In this case, a stopper (not shown in the drawings) may be provided on the proximal end side of the surgical tool 1 and the retention forceps 14, which are connected via a slider 15. While pressing the base of the left atrial appendage with the pressing part 3 and stretching the left atrial appendage with the retention forceps 14, the positions of the shafts of the surgical tool 1 and the retention forceps 14 are locked. As a result, the force of the stretched atrial appendage trying to return to the unstretched state can be decreased, the exposed state can be maintained, and thus ligation can be facilitated.
As shown in
The procedure according to this configuration is described next.
First, when the left atrial appendage is retained with the retention forceps 14, the pressing tool 3 of the surgical tool 1 for atrial appendage ligation is disposed on the proximal end side of the jaws of the retention forceps 14. Next, the tip of the atrial appendage is retained by the retention forceps 14, and a proximal side operation unit 20 of the retention forceps 14 is pulled toward the proximal end side. As a result, the shaft 2, which is engaged with a gear 22 of a connecting portion 21, of the surgical tool 1 protrudes forward due to the movement of the gear 22. By this operation, pulling the retention forceps 14 toward the proximal end side and pressing the atrial appendage with the pressing part 3 can be easily carried out in one action, and the operation time can be shortened.
In this embodiment, an example of the contact portions 4 that indent the surface of the atrial appendage A with the pressing force has been described. Alternatively, the contact portions 4 may be suction pads, and the atrial appendage A may be constricted by suctioning the surface of the atrial appendage A.
Another surgical tool that can be employed is a surgical tool 1 for atrial appendage ligation in which the spacing between three bar-shaped contact portions, which are separated from one another as shown in
In this embodiment, a pressing part 3, which has two contact portions 4, has been described as an example. Alternatively, as shown in
Number | Date | Country | Kind |
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2014-039815 | Feb 2014 | JP | national |
This is a continuation of International Application PCT/JP2015/053850, with an international filing date of Feb. 12, 2015, which is hereby incorporated by reference herein in its entirety. This application claims the benefit of Japanese Patent Application No. 2014-039815, filed on Feb. 28, 2014, the content of which is incorporated herein by reference.
Number | Date | Country | |
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Parent | PCT/JP2015/053850 | Feb 2015 | US |
Child | 15204231 | US |