JP2018075248A - Stent graft, stent graft set, and stent graft indwelling device - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a stent graft being easily placed at an appropriate position.SOLUTION: A stent graft 10 is a tubular stent graft delimiting a flow passage in which a blood flow can pass. The stent graft 10 includes: a skeleton part 11 capable of contracting radially inward and expanding radially outward; and a membrane part 12 provided along the skeleton part 11. The stent graft 10 is deformable from a contracted state in which the skeleton part 11 is contracted, to the expansion state in which the skeleton part 11 is expanded and the flow passage is delimited by the membrane part 12. The membrane part 12 includes an opening part 13. In the expanded state, the opening part 13 has a recess area 14 where a part of a peripheral edge of the opening part is recessed in a direction of separating from a center P of the opening part, and has such an opening shape that an opening width L is gradually reduced with it approaching from the center P of the opening part toward a deepest part Q of the recess area 14.SELECTED DRAWING: Figure 2

Description

  The present invention relates to a stent graft, a stent graft set that is a combination of the stent graft and another stent graft, and a stent graft placement device for placing the stent graft in a blood vessel.

  Conventionally, stent grafts used for the treatment of aortic aneurysms and aortic dissections occurring in the aorta are known. A stent graft generally has a tubular shape that defines a flow path through which a blood flow can pass, and is capable of contracting radially inward and expanding radially outward (stent), and the skeleton And a coating part (graft) provided along the part. The stent graft is transferred to the affected area (where an aortic aneurysm or the like is generated) in a contracted state in which the skeleton contracts, and then deformed into an expanded state in which the skeleton is expanded. As a result, the stent graft reinforces the blood vessel and blocks blood inflow to the aortic aneurysm or the like, thereby suppressing the expansion (growth) of the aortic aneurysm or the like.

  For example, one of the conventional stent grafts (hereinafter referred to as “conventional stent graft”) maintains the blood flow from the main blood vessel to the branch blood vessel while blocking the blood inflow to the aortic aneurysm or the like generated in the main blood vessel. For this purpose, a side surface of the stent graft placed in the main blood vessel is provided with a circular opening (circular opening) that opens toward the branch blood vessel (see, for example, Patent Document 1).

Japanese Patent No. 5789867

  Conventional stent grafts are placed in the main blood vessel so that the positions of the circular opening and the branch blood vessel are aligned with each other, thereby exerting an effect of maintaining the blood flow from the main blood vessel to the branch blood vessel. . However, due to the function of the circular opening, the conventional stent graft needs to be placed with high positional accuracy so that the positional deviation between the circular opening and the blood vessel opening of the branch vessel is minimized. In other words, when the conventional stent graft has insufficient positional accuracy at the time of placement, there is a possibility that the original function cannot be sufficiently exhibited (the blood flow to the branch blood vessel cannot be sufficiently maintained).

  On the other hand, in general, placement of a stent graft is performed based on a fluoroscopic image (two-dimensional planar image) by an X-ray fluoroscope. For this reason, it is generally difficult to position a conventional stent graft so that the circular opening of the conventional stent graft is sufficiently matched to the branch vessel (particularly in the rotational direction around the axis of the conventional stent graft). Yes, very advanced technology is required for such an arrangement.

  However, from the viewpoint of facilitating placement of the stent graft as much as possible, the conventional stent graft is configured so that the alignment between the branch vessel and the circular opening that opens toward the branch vessel is as easy as possible. It is desirable.

  The present invention has been made in view of the above-described circumstances, and an object of the present invention is to provide a stent graft that can be easily placed in an appropriate position, a stent graft set that is a combination of the stent graft and another stent graft, and the stent graft. An object of the present invention is to provide a stent graft placement device for placement in a blood vessel.

In order to achieve the above-described object, the “stent graft” according to the present invention is characterized by the following (1) to (5).
(1)
A tubular stent graft defining a flow path through which blood flow can pass,
A skeleton portion capable of contracting radially inward and expanding radially outward, and a coating portion provided along the skeleton portion, and the skeleton portion from a contracted state in which the skeleton portion contracts Is expanded and can be transformed into an expanded state in which the flow path is defined by the coating portion,
The coating part has an opening that penetrates the coating part in the radial direction of the stent graft,
In the expanded state, the opening has a recessed region in which a part of the periphery of the opening is recessed in a direction away from the center of the opening, and approaches the deepest portion of the recessed region from the center. A stent graft having an opening shape in which the opening width gradually decreases.
(2)
The stent graft according to (1) above,
A stent graft, further comprising a reinforcing member capable of suppressing deformation of the opening shape of the opening, the reinforcing member being disposed so as to surround at least a periphery corresponding to the recessed region of the periphery of the opening. There is.
(3)
In the stent graft according to (1) or (2) above,
The stent graft has a curved shape around a predetermined center of curvature on an outer peripheral surface of the stent graft in the expanded state;
The opening is configured such that the distance between the deepest location of the depression region and the bending center point is shorter than the distance between the location on the periphery different from the depression region and the bending center point. The stent graft.
(4)
In the stent graft according to any one of (1) to (3) above,
The skeleton has a curved shape that is curved around the opening so as to avoid the opening, and has a curved shape that is different from the shape of the skeleton at a location different from the periphery of the opening. The stent graft.
(5)
The stent graft according to any one of (1) to (4) above,
It is a stent graft further provided with a radiopaque indicator portion arranged in the vicinity of the opening.

  According to the stent graft configured as described in (1) above, the opening provided on the outer peripheral surface (coating portion) of the stent graft has a recessed region in which a part of the periphery of the opening is recessed in a direction away from the center of the opening. At the same time, it has an opening shape in which the opening width gradually decreases from the center of the opening toward the deepest portion of the recessed area. Therefore, for example, a guide wire that is placed so as to pass through the branch blood vessel and main blood vessel when performing the pull-through method is inserted in advance through the opening of the stent graft, and the opening is moved so as to bring the hollow region closer to the guide wire. If it does, it will originate in the opening shape (shape where opening width becomes small gradually) mentioned above, and a guide wire will be naturally guided to a hollow area. Next, if the opening is gradually moved while the depression region is in contact with the guide wire (that is, in the state where the guide wire enters the depression), the opening is guided by the guide wire and naturally becomes a branched blood vessel. It will approach. In other words, the opening and the branch blood vessel are naturally aligned.

  Further, by moving the opening while the depression region is in contact with the guide wire (in a state where the guide wire enters the depression), the guide wire is hardly separated from the depression region (the deepest portion thereof). In other words, the state where the guide wire is in contact with a specific position on the peripheral edge of the opening (the deepest portion of the recessed area) is more reliably maintained as compared with the case where a simple circular opening such as a conventional stent graft is used. As a result, when the opening is moved along the guide wire, the contact portion (deepest portion) between the guide wire and the opening is prevented from being displaced. As a result, alignment between the branch blood vessel and the opening can be performed with high accuracy.

  Therefore, the stent graft of this configuration is easier to align the opening of the stent graft and the branch blood vessel than the conventional stent graft, and can be easily placed at an appropriate position.

  By the way, the “center of the opening” represents the geometric gravity center position of the opening when the opening is viewed from the radially outer side of the stent graft. The “recessed area” can also be referred to as an area in which a peripheral edge is located at a position farther from the center of the opening than a peripheral edge (virtual peripheral edge) assuming that there is no recess (see FIG. 2C). reference). The “deepest part of the recessed area” represents a place where the distance between the center of the opening and the periphery is the largest among the positions on the periphery in the recessed area. The “opening width” represents the width of the opening in the direction perpendicular to the straight line connecting the center of the opening and the deepest portion and along the opening surface.

  As described above, when aligning the branch blood vessel and the opening, the guide wire is given a tension that does not cause the guide wire to bend excessively even if the opening contacts the guide wire. It is preferable that

  According to the stent graft having the configuration (2), the recessed region of the opening of the stent graft is reinforced by the reinforcing member. Therefore, compared with the case where there is no such reinforcing member, even if the opening is moved along the guide wire as described above, the opening is hardly damaged.

  According to the stent graft configured as described in (3) above, even when the stent graft has a predetermined curved shape (for example, a shape corresponding to the curved shape of the main blood vessel in which the stent graft is placed), the guide graft is opened. The stent graft can be placed while keeping the recessed area of the part. Specifically, when the main blood vessel has a curved shape (a shape curved around the bending center point), the tensioned guide wire normally has a blood vessel opening of the branch blood vessel and its bending center point. Are extended linearly (see FIG. 7). On the other hand, with the stent graft having a curved shape corresponding to the shape of the main blood vessel, the depression region (deepest portion) of the opening is directed to the curved central point of the curved shape (the deepest portion and the curved central point If the distance is provided (so that the distance is shorter than the distance between the other part on the periphery and the center of curvature), the recessed area of the opening can be arranged on the path along which the guide wire extends. Therefore, the stent graft of this configuration can be easily placed at an appropriate position even when the stent graft has a curved shape.

  According to the stent graft configured as described in (4) above, when an opening is arranged at a position where the skeleton is provided, the skeleton is curved only in the peripheral region of the opening, and the skeleton is usually used in other regions. (For example, a zigzag shape). Therefore, the opening can be provided at an arbitrary position without impairing the original function of the skeleton part (function of contracting and expanding the stent graft) as much as possible.

  According to the stent graft having the configuration of (5) above, after placing the stent graft while guiding the opening (indentation region) on the guide wire as described above, the index portion (marker) is used using a fluoroscopic image by the X-ray fluoroscope. Is compared with the position of the blood vessel opening of the branch blood vessel, it can be confirmed whether or not the branch blood vessel and the opening are properly aligned.

  In addition, from the viewpoint of more reliably placing the stent graft in an appropriate position, the position of the index portion (marker) is confirmed using a fluoroscopic image by an X-ray fluoroscopic apparatus, and an opening portion (dent region) is formed in the guide wire as described above. ), The stent graft may be placed.

Furthermore, in order to achieve the above-mentioned object, the “stent graft set” according to the present invention is characterized by the following (6).
(6)
A stent graft comprising: a first stent graft that is the stent graft according to any one of (1) to (5) above; and a tubular second stent graft that is connectable to the opening of the first stent graft. Be a set.

  According to the stent graft set having the configuration (6), the second stent graft (branch stent graft) is connected to the opening of the first stent graft (main stent graft) having the characteristics (1) to (5). Thus, the blood inflow to the aortic aneurysm or the like generated in the vicinity of the branching position between the main blood vessel and the branching blood vessel is blocked, and the aortic aneurysm or the like can be treated.

Furthermore, in order to achieve the above-mentioned object, the “stent graft indwelling device” according to the present invention is characterized by the following (7).
(7)
A stent graft placement device for placing a stent graft in a blood vessel,
The stent graft according to any one of (1) to (5) above;
A tube that is arranged to pass through the opening of the stent graft and can be inserted through a guide wire used when the stent graft is placed, or a guide wire that is used when the stent graft is placed and passes through the opening. A guide wire placed in
A storage device in which the stent graft in the contracted state is stored;
A stent graft placement device comprising: an operation tool that releases the stent graft from the container and deforms the stent graft into the expanded state.

  According to the stent graft indwelling device having the above configuration (7), it is possible to provide a set of instruments for indwelling the stent graft having the features (1) to (5) in the blood vessel. Specifically, for example, if a guide wire used in the pull-through method is inserted into an indwelling device through a tube arranged so as to pass through the opening of the stent graft, the opening becomes the guide wire as described above when the stent graft is indwelled. Moved along. For the same reason, when the guide wire itself is built in the indwelling device, the guide wire may be disposed so as to pass through the opening of the stent graft instead of using a tube.

  According to the present invention, it is possible to provide a stent graft that can be easily placed at an appropriate position, a stent graft set that is a combination of the stent graft and another stent graft, and a stent graft placement device for placing the stent graft in a blood vessel. .

  The present invention has been briefly described above. Further, details of the present invention will be further clarified by reading a form for carrying out the invention described below (hereinafter referred to as “embodiment”) with reference to the accompanying drawings.

FIG. 1 (a) is a diagram schematically showing substantially the entire aorta of the human body (from the ascending aorta to the common iliac artery), and FIG. 1 (b) is an enlarged view of the thoracic aorta, which is a part of the aorta of the human body. FIG. 2A is a perspective view showing a stent graft according to an embodiment of the present invention, FIG. 2B is a plan view of the stent graft, and FIG. 2C is an enlarged view for explaining the shape of the opening. FIG. Fig. 3 (a) is a view showing each component constituting the stent graft indwelling device according to the embodiment of the present invention, and Fig. 3 (b) is a view showing the same indwelling device in which each component is assembled. FIG. 4A is an enlarged perspective view showing the distal end portion of the stent graft indwelling device in a state where the stent graft held by the holding portion of the inner rod is exposed, and FIG. 4B is a perspective view of FIG. FIG. 4C is an enlarged perspective view showing the distal end portion of the indwelling device in a state of covering the stent graft held by the holding portion. FIGS. 5A to 5G are a series of diagrams for explaining a procedure for placing a stent graft in the aorta using the stent graft placement device. FIGS. 6A to 6F are diagrams for explaining a procedure for positioning the branch blood vessel and the opening (corresponding to the stage shown in FIG. 5E). Fig.7 (a) is a side view which shows an example of the passage route of the guide wire which passes in the inside of the main blood vessel which has a curved shape, FIG.7 (b) is detained in the main blood vessel shown to Fig.7 (a). It is a side view for demonstrating the position of the opening part (dent area | region) provided on a stent graft, FIG.7 (c) is a top view of FIG.7 (b). FIGS. 8A and 8B are diagrams illustrating an example of a procedure for providing a reinforcing member in the opening, and FIG. 8C is an example in the case where an X-ray impermeable indicator is provided in the reinforcing member. FIG. 8D is an enlarged view of the index portion in FIG. FIGS. 9A and 9B are views showing a first modification and a second modification of the opening of the stent graft. FIG. 10A is a view showing a state in which a branch stent graft is connected to the opening of the main stent graft, and FIG. 10B is a cross-sectional view showing an enlarged connection portion in FIG. .

<Aorta and stent graft>
Hereinafter, as a preparation for explaining an embodiment of the present invention, first, a structure of a human aorta and a stent graft used for treatment of an aortic aneurysm will be briefly described with reference to FIG.

  As shown in FIG. 1 (a), the aorta of the human body rises from the left ventricle of the heart, bends in an arcuate shape, and then descends until it branches to the common iliac artery at the branch point of the abdominal aorta It is an artery that is the source of blood circulation throughout the body. A state in which a part of the blood vessel wall constituting the aorta is swollen is called “aortic aneurysm”. On the other hand, a state in which the media is peeled (dissociated) by blood flowing out through a tear or the like formed in the intima of the blood vessel wall constituting the aorta is called “aortic dissection”. These aortic aneurysms and the like can occur in various parts of the aorta. An aortic aneurysm is a serious disease that can lead to death if left untreated.

  As a surgical treatment method for an aortic aneurysm or the like, a so-called “artificial blood vessel replacement” in which the affected blood vessel in which the aortic aneurysm or the like is formed is replaced with an artificial blood vessel is well known. On the other hand, in recent years, a technique called “stent graft insertion” has attracted attention. This method is a method using a stent graft indwelling device including a stent graft having a reduced diameter inside the sheath. Specifically, in this method, for example, a small incision is made at the base of the thigh called an inguinal portion, the sheath is inserted into the aorta, the stent graft is exposed and deployed from the distal end of the sheath at the affected portion, and the stent graft is placed in the affected portion. This is a method for preventing the rupture of an aortic aneurysm or the like. Stent graft insertion is a less invasive treatment method that does not require thoracotomy or laparotomy as compared to artificial blood vessel replacement.

  As shown in FIG. 1B, among the aorta, particularly in the thoracic aorta, there are three branch arteries (branch blood vessels) that branch from the aorta (main blood vessel). The stent graft according to the embodiment of the present invention can be used particularly for the treatment of an aortic aneurysm or the like generated in the aorta near the branch position between the aorta and the branch artery. In addition, the stent graft according to the embodiment of the present invention can be used for treatment of an aortic aneurysm or the like generated in another site (abdominal aorta or the like).

<Stent graft>
Hereinafter, first, a stent graft 10 (main stent graft) according to an embodiment of the present invention will be described with reference to FIGS. 2 (a) to 2 (c). The stent graft 10 is placed in the affected part of the aorta (where an aortic aneurysm or the like is generated), and in particular, is placed in the affected part near the branch position between the aorta and the branch artery.

  As shown in FIGS. 2A to 2C, the stent graft 10 has a tubular shape that defines a flow path through which a blood flow can pass, and has a skeleton 11 (stent) and a coating 12 (graft). ). In this example, the stent graft 10 has a straight tube shape. However, the shape of the stent graft 10 is not necessarily limited to a linear shape, and may have a curved tube shape (for example, in a shape corresponding to the shape of the patient's aortic arch) as necessary (see FIG. 7 described later). reference). The stent graft 10 may have a curved shape that assumes an indwelling location in advance before placement, or may have a curved shape that conforms to the blood vessel shape after placement.

  The skeleton portion 11 is configured in a self-expanding wire mesh shape in which metal thin wires are folded back in a zigzag shape and formed into a tubular shape, and expands radially outward from a contracted state contracted radially inward to a tubular flow path Can be transformed into an expanded state where is defined. Examples of the material constituting the skeleton part 11 include known metals or metal alloys represented by stainless steel, Ni-Ti alloy, titanium alloy, and the like.

  The film portion 12 is fixed to the skeleton portion 11 so as to cover the skeleton portion 11 along the skeleton portion 11, and defines the above-described tubular channel. The film part 12 may cover the skeleton part 11 from the outer periphery or the inner periphery, or may cover the skeleton part 11 so as to be sandwiched from the outer periphery and the inner periphery. Examples of the material of the film part 12 include a fluororesin such as PTFE (polytetrafluoroethylene) and a polyester resin such as polyethylene terephthalate.

  The coating portion 12 has an opening 13 (through hole) that penetrates the coating portion 12 in the radial direction of the stent graft 10. In this example, as shown in FIG. 2 (c) in particular, the opening 13 has a recessed area 14 (a case where it is assumed that there is no depression) where a part of the peripheral edge is recessed in a direction away from the center P of the opening 13. It has a peripheral edge (a region in which a peripheral edge is located at a position farther from the center P than a peripheral edge (broken line D in the figure)). In this example, the direction in which the recessed region 14 is recessed corresponds to the axial direction of the stent graft 10. Furthermore, the opening 13 has an opening shape in which the opening width L gradually decreases from the center P of the opening 13 toward the deepest portion Q of the recessed area 14. The peripheral edge of the opening 13 other than the recessed area 14 has a substantially circular shape. As will be described later, the opening 13 also functions as a portion to which the connection-side end portion 23 of the branch / stent graft 20 is connected (see FIG. 10 described later).

  A portion 11 a located around the opening 13 in the skeleton 11 is curved so as to avoid the opening 13. Thereby, the opening part 13 can be provided in arbitrary positions, without impairing the original function of the frame | skeleton part 11. FIG. In addition, when the opening part 13 does not interfere with the skeleton part 11, the skeleton part 11 may not be curved.

<Stent graft placement device>
Next, a stent graft indwelling device 1 (hereinafter simply referred to as “indwelling device 1”) for placing the stent graft 10 at a predetermined position in the blood vessel will be described with reference to FIGS. Hereinafter, in FIGS. 3 and 4, the right side is referred to as the proximal end side, and the left side is referred to as the distal end side.

  As shown in FIGS. 3A and 3B, the indwelling device 1 includes a tubular outer sheath 30 (accommodating tool) and an inner sheath 30 arranged inside the outer sheath 30 in the axial direction of the outer sheath 30 ( A rod-shaped inner rod 40 (operating tool) configured to be movable back and forth along the longitudinal direction). The outer sheath 30 includes a sheath main body 31 and a hub 32 provided on the proximal end side of the sheath main body 31. The hub 32 includes a nut (not shown) or the like for fixing the inner rod 40 to the outer sheath 30 or releasing the fixing.

  The outer sheath 30 is formed of a flexible material. Examples of flexible materials include biocompatible synthetic resins (elastomers) selected from fluororesins, polyamide resins, polyethylene resins, and polyvinyl chloride resins, and other materials for these resins. And the like, a composite structure of these synthetic resins and metal wires, and the like.

  As shown in FIG. 3A, the inner rod 40 includes a rod main body portion 41, a holding portion 42 that holds the stent graft 10 in a contracted state, and a distal tip provided at an end portion on the distal end side of the inner rod 40. 43. The holding portion 42 is smaller in diameter than the rod main body portion 41 by the thickness of the stent graft 10. Therefore, the outer diameter of the stent graft 10 in the contracted state held by the holding portion 42 is substantially equal to the outer diameter of the rod main body portion 41. As can be understood from FIG. 3B, the maximum diameter of the distal tip 43 is substantially equal to the outer diameter of the sheath body 31 of the outer sheath 30. Further details of holding the stent graft 10 will be described later with reference to FIGS. 4 (a) to 4 (c).

  Examples of the material constituting the rod main body 41 and the holding part 42 include various materials having appropriate hardness and flexibility such as resin (plastic and elastomer) and metal. Examples of the material constituting the tip chip 43 include various materials having appropriate hardness and flexibility, such as a synthetic resin (elastomer) composed of a polyamide resin, a polyurethane resin, a polyvinyl chloride resin, or the like. It is done.

  As shown in FIGS. 4A to 4C, the indwelling apparatus 1 includes a resin or rubber tube 50 through which a metal guide wire 60 is inserted. The stent graft 10 in the contracted state held by the holding part 42 is actually contracted in the radial direction, and the opening 13 is actually deformed to be crushed (different from the shape in the expanded state). It may be a shape). However, for convenience of explanation, in FIG. 4A, the opening 13 is described in the same shape as that in the expanded state.

  As shown in FIGS. 4A and 4B, the distal end side end of the tube 50 is located inside a groove 43 a formed on the side surface of the distal end tip 43. The tube 50 extends from the distal end side toward the proximal end side of the stent graft 10 to the opening portion 13, passes through the opening portion 13 and enters the inside of the stent graft 10, and the proximal end portion of the stent graft 10. It extends to the part. Thereafter, the tube 50 is connected to a guide wire fine hole 41a (through hole) formed so as to penetrate the rod main body 41 in the axial direction at the distal end side end of the rod main body 41. .

  As shown in FIG. 4C, the sheath main body 31 of the outer sheath 30 is slid from the state shown in FIG. 4A to the distal end side, and the stent graft 10 held by the holding part 42 is covered with the sheath main body 31. Even in this state, the end of the tube 50 accommodated in the groove 43a is exposed. That is, the indwelling device 1 is configured such that the guide wire 60 can be inserted into the tube 50 from the outside of the indwelling device 1 while maintaining the form of the indwelling device 1 shown in FIG.

  Although not illustrated, the rod body 41, the holding part 42, and the distal tip 43 have trigger wire pores for inserting a trigger wire for expanding the contracted stent graft 10 at the affected part. Are formed along the axial direction. Furthermore, although a detailed description is omitted, the distal tip 43 is provided with a locking groove (not shown) for locking the trigger wire. As a method for expanding the contracted stent graft 10 in the affected area using such a trigger wire and a tip, a known method can be used.

  Next, a procedure for placing the stent graft 10 on the affected part in the aorta using the indwelling apparatus 1 shown in FIG. 3B will be described with reference to FIGS. 5 and 6. FIG. 5 shows an example in which the stent graft 10 is placed in a curved aortic arch in the thoracic aorta (see FIG. 1B) so that the brachiocephalic artery and the opening 13 are aligned.

  First, as a preliminary preparation, the patient's arm and thigh root are cut into small portions, the guide wire 60 is inserted into the brachiocephalic artery from the arm incision portion, and led out from the incision portion of the thigh through the aorta. Then, as shown in FIG. 4C, the guide wire 60 led out from the crotch is inserted into the tube 50 from the distal end of the indwelling device 1.

  Next, as shown in FIG. 5A, the outer sheath 30 is guided from the incision portion of the crotch to the vicinity of the distal arch aorta using the guide wire 60 inserted into the blood vessel as described above. Thus, the entire indwelling apparatus 1 is advanced.

  Next, as shown in FIG. 5B, the guide wire 60 is pushed in from the incised portion side of the arm to loosen the guide wire 60 so as to precede the distal end portion of the outer sheath 30 in the aortic arch, and then FIG. As shown in c), the outer sheath 30 is advanced to the vicinity of the proximal arch aorta. Thus, if the outer sheath 30 is advanced to the vicinity of the proximal arch aorta, the distal end portion of the indwelling device 1 is made to reach the position (affected part) of the aortic aneurysm or the like generated in the aortic arch near the brachiocephalic artery. It is done.

  After the distal end of the indwelling apparatus 1 reaches the affected area, as shown in FIG. 5 (d), the outer sheath 30 is moved so as to be pulled out while the position of the inner rod 40 is fixed, and the stent graft 10 is extracted from within the outer sheath 30. Is exposed (released). The stent graft 10 is self-expanded radially outward by being exposed to the outside from the outer sheath 30. At this time, the guide wire 60 passes through the opening 13. The tube 50 has entered the inside of the stent graft 10 as the stent graft 10 is expanded. However, in this state, since the distal tip 43 is not separated from the stent graft 10 and most of the stent graft 10 is accommodated in the outer sheath 30, the stent graft 10 is not yet in close contact with the inner wall surface of the blood vessel.

  Next, in a state where the stent graft 10 is not in close contact with the inner wall surface of the blood vessel, a predetermined tension is applied to the guide wire 60 as shown in FIG. Align with. Hereinafter, this alignment will be described with reference to FIG. In FIG. 6, illustration of the inner rod 40, the left common carotid artery, the left subclavian artery, and the like is omitted for convenience of explanation.

  FIG. 6A and FIG. 6B show a state before alignment. In this state, the guide wire 60 is loose. Further, there is a displacement between the connection portion 73 between the aortic arch 71 (main blood vessel) and the brachiocephalic artery 72 (branch blood vessel) and the opening 13 in both the axial direction of the stent graft 10 and the rotational direction around the axis. Has occurred.

  From this state, tension is applied to the guide wire 60 as shown in FIGS. 6 (c) and 6 (d). This tension is generated, for example, by pulling the guide wire 60 from the incised portion side of the arm. When tension is applied to the guide wire 60 in this way, the guide wire 60 is stretched up to the outer sheath 30 over the connection portion 73 (corner portion). The position of the outer sheath 30 is also moved due to this tension (see also FIG. 7). In this state, when the opening 13 is moved so as to bring the hollow region 14 closer to the guide wire 60, the guide wire 60 is caused by the above-described opening shape (a shape in which the opening width L is gradually reduced, see FIG. 2). Is naturally guided to the recessed area 14. As a result, as shown in FIGS. 6C and 6D, a state in which the guide wire 60 is fitted in the recessed region 14 is obtained.

  From this state, as shown in FIGS. 6E and 6F, the stent graft 10 is pushed in the black arrow direction. This pushing is done by pushing the rod body 41 in the direction of the black arrow. As described above, when the stent graft 10 is pushed in, the opening 13 moves toward the connection portion 73 (the portion where the guide wire 60 is bridged) while the hollow region 14 is guided along the guide wire 60 (see the white arrow). ). As a result, the brachiocephalic artery 72 and the opening 13 are aligned. Thus, by aligning the recessed region 14 provided in the opening 13 with the guide wire 60, the opening 13 can be easily aligned with the branch blood vessel 82. Further, by moving the opening while the recessed area 14 is in contact with the guide wire 60 (in a state where the guide wire 60 enters the recessed area), the guide wire 60 is hardly separated from the recessed area 14 (the deepest portion thereof). The accuracy of alignment can be increased.

  Referring to FIG. 5 again, when the alignment between the brachiocephalic artery 72 and the opening 13 is completed in FIG. 5 (e), the distal tip 43 is separated and the stent graft 10 is separated as shown in FIG. 5 (f). The distal end of the stent graft 10 is expanded radially outward to bring the stent graft 10 into close contact with the inner wall surface of the blood vessel. Then, the holding portion 42 and the like are accommodated in the outer sheath 30 leaving only the guide wire 60. Then, as shown in FIG. 5G, the entire indwelling apparatus 1 is extracted by extracting the guide wire 60 together with the outer sheath 30. Thereby, the placement of the stent graft 10 is completed. As a result, the blood flow to the brachiocephalic artery 72 (branch vessel) is maintained while blocking the blood inflow to the aortic aneurysm or the like generated in the aortic arch 71 (main vessel) near the brachiocephalic artery 72 (branch vessel). it can.

  Although not shown in FIGS. 2 to 6, the stent graft 10 corresponds to the left common carotid artery and the left subclavian artery (see FIG. 1) separately from the opening 13 corresponding to the brachiocephalic artery 72. May have an opening. In this case, if the relative position of each opening can be grasped by a preoperative examination or the like, one of these openings (in this example, the opening 13) is connected to the other branch blood vessel (in this example, the arm head). If properly aligned with the artery 72), the other openings will naturally be properly aligned. In addition, when aligning a plurality of openings collectively as described above, it is preferable to perform the initial alignment (of the first opening) before the stent graft 10 is in close contact with the inner wall surface of the blood vessel. It is preferable to apply the recessed region 14 and the opening shape of the present invention to the opening closest to the heart side end of the stent graft 10.

  In the present embodiment, the indwelling device 1 incorporating the tube 50 is used, and the indwelling device 1 is moved toward the affected part along the guide wire 60 that has been placed in the blood vessel in advance. However, in place of the tube 50, the indwelling device 1 in which the guide wire 60 is embedded with the opening 13 being passed is used, and the guide wire 60 is extended from the indwelling device 1 during indwelling and passed through the blood vessel in advance. After that, the indwelling apparatus 1 may be moved toward the affected area in the same manner as described above. However, also in the latter case, the alignment procedure is the same as the former (FIGS. 5 and 6).

  Hereinafter, referring to FIG. 7, when the stent graft 10 is placed in the main blood vessel 81 that is curved in the vicinity of the connection portion 83 between the main blood vessel 81 and the branch blood vessel 82 (as described above, the placement of the stent graft 10 around the aortic arch). The preferable arrangement of the recessed region 14 of the opening 13 in the case) will be described. In FIG. 7, the illustration of the inner rod 40 and the like is omitted for convenience of explanation. Note that this description is not limited to the placement in the aortic arch described above, but also applies to placement in other blood vessels.

  As shown in FIG. 7A, when the main blood vessel 81 is curved in the vicinity of the connection portion 83 between the main blood vessel 81 and the branch blood vessel 82, when tension is applied to the guide wire 60, the guide wire 60 is usually It spans two places: a point A that is a part of the connecting portion 83 and a point B that is a part of the inner wall inside the bending portion of the main blood vessel 81 (a bending center point). That is, the guide wire 60 extends so as to linearly connect the point A and the point B. When the outer sheath 30 extends between the point A and the point B, the outer sheath 30 spans the point B as shown in the figure.

  Therefore, assuming that the stent graft 10 is preliminarily formed into a shape corresponding to the shape of the main blood vessel 81, assuming that the stent graft 10 is placed in the main blood vessel 81 shown in FIG. As shown in FIG. 7B and FIG. 7C showing the stent graft 10 as viewed from above, the recessed region 14 of the opening 13 is the peripheral edge of the opening 13. It is preferably provided at a position closest to the bending center point R of the stent graft 10 (a position facing the bending center point R). In other words, the opening 13 is formed such that the distance between the deepest portion Q of the recessed region 14 and the bending center point R is shorter than the distance between the location on the periphery different from the recessed region 14 and the bending center point R. It is preferable. Thereby, when the stent graft 10 is indwelled, the recessed region 14 is positioned in the direction along the passage route of the guide wire 60, and the alignment accuracy between the branch blood vessel 82 and the opening 13 is improved.

  As will be understood from the above principle, whether the stent graft 10 has a pre-shaped shape or a straight shape without being pre-shaped, the indented region 14 extends in the direction along the axis of the stent graft 10. If it is depressed (although inferior to the said aspect), the effect similar to the said aspect can be anticipated. Therefore, the recessed region 14 may be provided so as to be recessed in the direction along the axis of the stent graft 10 (although the above-described embodiment is desirable).

<Other aspects>
In addition, this invention is not limited to said each embodiment, A various modification is employable within the scope of the present invention. For example, the present invention is not limited to the above-described embodiments, and modifications, improvements, and the like can be made as appropriate. In addition, the material, shape, dimensions, number, arrangement location, and the like of each component in the above-described embodiment are arbitrary and are not limited as long as the present invention can be achieved.

  For example, a reinforcing member may be provided around the opening 13. Specifically, for example, as shown in FIG. 8 (a), the reinforcing member 15 disposed at a position corresponding to the opening 13 is sandwiched between the two coating sheets 12a and 12b, and thereafter, FIG. ), An unnecessary portion corresponding to the opening 13 (and the recessed region 14) is punched out. As a result, the reinforcing member 15 having a similar shape slightly larger than the opening 13 is embedded around the opening 13. Thereby, when moving the opening part 13 (dent area | region 14) along the guide wire 60, a deformation | transformation of the opening part 13 can be suppressed and damage to the opening part 13 (dent area | region 14) etc. can be prevented. In addition, the reinforcing member 15 should just be arrange | positioned so that the periphery corresponding to the hollow area | region 14 at least among the periphery of the opening part 13 may be surrounded. The reinforcing member 15 can typically be formed from a shape memory alloy (eg, Nitinol). The reinforcing member 15 may be formed of silicone, rubber, elastomer, or the like.

  Furthermore, a cylindrical marker 16 (index part) made of a radiopaque material may be provided in the vicinity of the opening 13. Specifically, for example, as shown in FIGS. 8C and 8D, the marker 16 may be inserted into and fixed to the reinforcing member 15. If the marker 16 is provided as described above, it is possible to confirm whether the position of the opening 13 is appropriate by confirming the position of the marker 16 by X-ray image after the placement of the stent graft 10.

  Furthermore, the shape of the opening 13 is not limited to the shape of the above-described embodiment, and as shown in FIG. 9A, a large hollow region 14 that protrudes outwardly in a V shape from both ends of the semicircle with a semicircle as a base. As shown in FIG. 9 (b), a rectangular shape is used as a base, and one side protrudes outward in a V shape and has a long hole-shaped small depression region 14 at the protruding end. May be.

  Furthermore, as shown in FIG. 10, the stent graft 10 (main stent graft) may be used while being connected to the branch stent graft 20. In this case, the main stent graft 10 and the branch stent graft 20 correspond to the “stent graft set” of the present invention. Hereinafter, the main stent graft is simply referred to as “main graft”, and the branch stent graft is simply referred to as “branch graft”.

  FIG. 10 shows an example in which the connection side end 23 of the branch graft 20 is connected to the opening 13 of the main graft 10 placed in the main blood vessel 81 and the branch graft 20 is placed in the branch blood vessel 82. As shown in FIG. 10 (a), the branch graft 20 also has a tubular shape that defines a tubular channel through which blood flow can pass, like the main graft 10, and has a self-expanding skeleton 21 and a coating. Part 22. The structure of the skeleton part 21 and the film part 22 is the same as that of the skeleton part 11 and the film part 12 of the main graft 10 (detailed description is omitted). The branch graft 20 is not provided with the opening 13. The end 23 (connection side end) of the branch graft 20 on the side connected to the opening 13 of the main graft 10 has a flange-like shape protruding radially outward as shown in FIG. 10B. . The placement of the branch graft 20 can also be performed in the same manner as the main graft 10 using the placement apparatus 1.

  As shown in FIG. 10B, in a state where the placement of the branch graft 20 is completed, the outer surface of the flange-like connection side end 23 of the branch graft 20, the inner surface of the opening 13 of the main graft 10, The main graft 10 and the branch graft 20 are connected so that they are in close contact with each other. Thereby, the leakage of blood (so-called end leak) from between the main graft 10 and the branch graft 20 can be suppressed.

1 stent graft placement device 10 stent graft (main graft, first stent graft)
DESCRIPTION OF SYMBOLS 11 Frame | skeleton part 12 Film | membrane part 13 Opening part 14 Indentation area | region 15 Reinforcement member 16 Marker (index part)
20 Stent graft (branch graft, second stent graft)
30 Outer sheath (container)
40 Inner rod (operating tool)
50 tube 60 guide wire

Claims (7)

A tubular stent graft defining a flow path through which blood flow can pass,
A skeleton portion capable of contracting radially inward and expanding radially outward, and a coating portion provided along the skeleton portion, and the skeleton portion from a contracted state in which the skeleton portion contracts Is expanded and can be transformed into an expanded state in which the flow path is defined by the coating portion,
The coating part is
Having an opening penetrating the coating portion in the radial direction of the stent graft,
The opening is
In the expanded state, a part of the periphery of the opening has a recessed region that is recessed in a direction away from the center of the opening, and the opening width gradually increases as approaching from the center toward the deepest portion of the recessed region. Having a smaller opening shape,
Stent graft. The stent graft according to claim 1,
A reinforcing member capable of suppressing deformation of the opening shape of the opening, and further comprising a reinforcing member disposed so as to surround at least a peripheral edge corresponding to the recessed region of the peripheral edge of the opening;
Stent graft. The stent graft according to claim 1 or 2,
The stent graft
In the expanded state, it has a curved shape around a predetermined curved center point on the outer peripheral surface of the stent graft,
The opening is
The distance between the deepest location of the depression region and the center of curvature is configured to be shorter than the distance between the location on the periphery different from the depression region and the center of curvature.
Stent graft. In the stent graft according to any one of claims 1 to 3,
The skeleton is
In the periphery of the opening, it has a curved shape that is curved so as to avoid the opening, and has a curved shape that is different from the shape of the skeleton at a location different from the periphery of the opening.
Stent graft. The stent graft according to any one of claims 1 to 4,
A radiopaque indicator disposed in the vicinity of the opening;
Stent graft. A first stent graft which is the stent graft according to any one of claims 1 to 5;
A tubular second stent graft connectable to the opening of the first stent graft,
Stent graft set. A stent graft placement device for placing a stent graft in a blood vessel,
The stent graft according to any one of claims 1 to 5,
A tube that is arranged to pass through the opening of the stent graft and can be inserted through a guide wire used when the stent graft is placed, or a guide wire that is used when the stent graft is placed and passes through the opening. A guide wire placed in
A storage device in which the stent graft in the contracted state is stored;
An operation tool that releases the stent graft from the container and deforms the stent graft into the expanded state.
Stent graft placement device.

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