Artificial blood vessel and artificial blood vessel kit

Abstract

Provided are an artificial blood vessel kit and an artificial blood vessel that are ideally suited for use in hybrid therapies, and that include: a first artificial blood vessel (12) that is tubular and at least one end of which can be sutured to another tubular body; an annular snap ring (22) that is attached to a hole (fenestration) (21) provided in the vessel wall of the first artificial blood vessel (12) and that contains radiopaque elements; and a second artificial blood vessel (13) that is put into the hole in the first artificial blood vessel (12). The snap ring (22) serves as a marker for manipulations under X-ray fluoroscopy, and retains the second artificial blood vessel (13) in the anastomotic area after the insertion of the second artificial blood vessel (13).

Description

Vascular grafts and vascular graft kits

[0001] The present invention relates to an artificial blood vessel and an artificial blood vessel kit, which are used for treating aortic aneurysms and the like.

[0002] Aortic aneurysms are diseases that can lead to sudden death if they rupture. They are classified into true aneurysms, which are caused by arteriosclerosis and affect elderly people, and dissecting aneurysms, which affect relatively young people. Both types of aneurysms have a high mortality rate if left untreated, so prophylactic procedures are often performed, such as artificial blood vessel replacement, in which the aneurysm is surgically removed and replaced with an artificial blood vessel, or aneurysm exclusion, in which a self-expanding artificial blood vessel (stent graft) is placed via an endovascular approach to block blood flow to the aneurysm. Examples of endovascular approaches are shown in Patent Documents 1 and 2.

[0003] However, the difficulty and risk of these treatments vary greatly depending on the location of the aortic aneurysm, and it is known that the risk of treatment is particularly high in the aortic arch. This is primarily due to the anatomical characteristics of the aortic arch. Because the aortic arch runs from the anterior chest to the posterior chest, surgical approach alone is difficult. Furthermore, because the aortic arch branches off to the brain (the brachiocephalic artery, left common carotid artery, and left subclavian artery), maintaining adequate cerebral blood flow using endovascular approaches alone is difficult.

[0004] Therefore, in recent years, hybrid treatments that combine surgical and endovascular approaches to solve the problems of both treatments in a complementary manner are often chosen.

[0005] Special Table 2015-527156 Special Table 2012-501205

[0006] In hybrid treatment, the anterior portion of the aortic arch, which is relatively easy to surgically approach, such as the ascending aorta, brachiocephalic trunk, and left common carotid artery, is first replaced with an artificial blood vessel, and then the posterior portion of the arch, such as the left subclavian artery and descending aorta, is vacated using an endovascular approach during surgery.

[0007] In this intraoperative endovascular approach, a self-expanding artificial blood vessel (stent graft) is inserted into the descending aorta through the blood vessels at the anterior part of the aortic arch. For the left subclavian artery, a hole (fenestration) is created in the self-expanding artificial blood vessel to match the opening, preserving blood flow.

[0008] However, if left in this state, blood will flow into the aneurysm through the fenestration, preventing it from being emptied. Therefore, after the chest is closed, an additional procedure is required on a later date to place a small-diameter stent graft bridging the left subclavian artery from the fenestration using a fully endovascular approach (catheterization). By performing this additional procedure, the posterior portion of the arch is emptied with the stent graft, completing the treatment.

[0009] However, in the current artificial vascular fenestration procedure, a hole is simply created by cutting away a portion of the artificial vascular graft. Therefore, when performing additional catheter manipulation at a later date, there is no landmark that can be recognized under X-ray fluoroscopy, making catheter insertion into the fenestration technically difficult. Furthermore, fenestrations created by the simple cutting method have been shown to have poor adhesion to small-diameter stent grafts, resulting in blood leakage from the connection site, which can allow blood flow to the aneurysm and result in a certain risk of not achieving aneurysm clearance.

[0010] Furthermore, in hybrid treatment, while performing extracorporeal circulation using a heart-lung machine or the like under thoracotomy, it is necessary to finally determine one or more artificial blood vessels that are suitable for the condition of the aortic blood vessels and aneurysm, perform surgery to replace the aorta with the artificial blood vessel, create a window in the artificial blood vessel that is suitable for the position and size of the branching blood vessel, insert it into the natural blood vessel, and then suture it to the surrounding natural blood vessel or another artificial blood vessel.

[0011] Therefore, it is necessary to perform these operations during thoracotomy as quickly as possible to reduce the physical burden on the patient as much as possible, and it is also necessary to make catheter operation easier and more reliable after thoracotomy.

[0012] In view of the above problems, an object of the present invention is to provide an artificial blood vessel kit and an artificial blood vessel that are suitable for use in hybrid treatment.

[0013] In particular, the objective is to make it easy to obtain landmarks when operating the catheter in hybrid treatment, as well as to facilitate the insertion of a stent graft from the fenestration into a branch vessel and reduce the risk of blood leakage by improving connectivity.

[0014] Another object of one embodiment of the present invention is to facilitate suturing of an artificial blood vessel having a fenestration formed therein in hybrid treatment, thereby widening the range of application to various pathologies.

[0015] An artificial blood vessel kit according to one embodiment of the present invention includes a first artificial blood vessel that is tubular and can be sutured to another tubular body at at least one end; an annular retaining ring that itself contains an X-ray opaque element and is attached to a hole (fenestration) provided in the tubular wall of the first artificial blood vessel to reinforce the peripheral portion of the hole; and a second artificial blood vessel to be inserted into and left in place in the hole of the first artificial blood vessel, wherein the retaining ring, when attached to the hole of the first artificial blood vessel, serves as a guide for operation under X-ray fluoroscopy to insert the second artificial blood vessel (e.g., a stent graft) inserted into the inside of the first artificial blood vessel through the hole and protrude outward from the first artificial blood vessel, and also holds the second artificial blood vessel at the anastomosis portion with the second artificial blood vessel after insertion of the second artificial blood vessel.

[0016] Preferably, the retaining ring has a main body member placed on one of the inner and outer surfaces of the pipe wall and a washer member placed on the other surface, the main body member having a tubular portion inserted into the hole and a flange portion continuous with one end of the tubular portion, the tubular portion of the main body member being plastically deformed after being inserted into an insertion hole provided in the washer member and pressed against the washer member, thereby attaching the retaining ring to the hole.

[0017] The flange and the washer member are provided with a through-hole at the same position on the tube wall, through which a sewing needle can pass.

[0018] In addition, a protrusion is provided on the outer periphery of the cylindrical portion, and a groove is provided on the inner periphery of the washer member, and the protrusion fits into and engages with the groove, making it possible to position the main body member and the washer member circumferentially.

[0019] Preferably, the artificial blood vessel kit includes a washer for insertion between the vascular wall and the body member and the washer member. The hole is provided in the vascular wall of the first artificial blood vessel to match the position and size of the second artificial blood vessel.

[0020] The retaining ring is elastically deformable so that the outer edge that contacts the periphery of the hole expands or deforms.

[0021] An artificial blood vessel according to one embodiment of the present invention is a tubular artificial blood vessel that can be sutured to another tubular body at at least one end, and has a hole in the tubular wall to which an annular retaining ring is attached to reinforce the peripheral portion, the retaining ring itself containing an X-ray opaque element, and has a through-hole near the end of the artificial blood vessel through which a sewing needle can pass.

[0022] According to the present invention, it is possible to provide an artificial blood vessel kit and an artificial blood vessel that are suitable for use in hybrid treatment.

[0023] It also makes it easier to obtain landmarks when operating the catheter in hybrid treatment, and it also makes it easier to insert the stent graft from the fenestration into the branch vessel and reduces the risk of blood leakage by improving connectivity.

[0024] Furthermore, according to one embodiment of the present invention, it becomes easier to suture an artificial blood vessel (first artificial blood vessel) with a fenestration formed therein in hybrid treatment, thereby making it possible to expand the range of application to various pathological conditions in the aorta.

[0025] FIG. 1 is a diagram showing an example of a state in which hybrid treatment has been performed on an aorta with an aneurysm using the artificial blood vessel kit according to the present invention. FIG. 2 is a diagram showing the process of attaching a retaining ring to a first artificial blood vessel. FIG. 3 is a diagram showing an example of a retaining ring. FIG. 4 is a cross-sectional view showing the process of fixing the retaining ring. FIG. 5 is a diagram showing an example of a state in which a first artificial blood vessel has been sutured to another blood vessel. FIG. 6 is a diagram showing a state in which a second artificial blood vessel is attached by inserting it through a fenestration portion of the first artificial blood vessel. FIG. 7 is a diagram showing another example of a retaining ring. FIG. 8 is a diagram showing another example of a retaining ring. FIG. 9 is a diagram showing another example of a first artificial blood vessel. FIG. 10 is a flowchart showing the flow of hybrid treatment. FIG. 11 is a flowchart showing the flow of an intraoperative endovascular approach. FIG. 12 is a flowchart showing the flow of a completely endovascular approach.

[0026] Hereinafter, an embodiment of the present invention will be described.

[0027] First, hybrid treatment (hybrid surgery) in this embodiment will be described with reference to the flowcharts shown in FIGS.

[0028] In hybrid treatment, for example, under thoracotomy (#1), the anterior portion of the aortic arch, which is relatively easy to surgically approach, such as the ascending aorta, brachiocephalic artery, and left common carotid artery, is replaced with an artificial blood vessel (main artificial blood vessel) (#2), and the posterior portion of the arch, such as the left subclavian artery and descending aorta, is vacated using an endovascular approach during surgery (#3).

[0029] In this intraoperative intravascular approach, a self-expanding artificial blood vessel (first artificial blood vessel) is prepared under thoracotomy (#11), and a hole (fenestration) is formed in the wall of the first artificial blood vessel to match the opening of the left subclavian artery (#12).A retaining ring matching the size of the fenestration is attached to the formed fenestration (#13).

[0030] After inserting and placing the first artificial blood vessel through the incision in the arch and into the descending aorta (#14), the end of the first artificial blood vessel is sutured to the incision in the arch to form a stoma, which is then sutured end-to-end to the main artificial blood vessel (#15).The chest is then closed (#4).The first artificial blood vessel placed in the arch has a fenestration, so blood flow is preserved.

[0031] However, if left in this state, blood will flow into the aneurysm through the fenestration, and the aneurysm will not be cleared. Therefore, after the chest is closed, a completely endovascular approach is performed again on a different day with the chest closed (#5).

[0032] In the fully endovascular approach, a small-diameter stent graft, which is a second artificial blood vessel, is prepared (#21), and by catheter manipulation (#22), the small-diameter stent graft is inserted into the fenestration (#23) and placed in place (#24) to reconstruct the left subclavian artery. This leaves the posterior portion of the arch free with the artificial blood vessel, completing the treatment.

[0033] In one embodiment of this hybrid treatment, a fenestration is created by cutting a hole in a self-expanding artificial blood vessel (first artificial blood vessel) using a cutting method, and then additional treatment is performed on the fenestration. This artificial blood vessel can be a commercialized device. As an additional treatment, metal retaining rings are attached to the inner and outer surfaces of the fenestration to reinforce the edges of the fenestration.

[0034] The retaining ring serves as a marker under X-ray fluoroscopy during subsequent catheter manipulation, facilitating insertion of the catheter into the fenestration. The retaining ring is made several millimeters thick, for example, 3 to 6 millimeters, specifically, about 5 millimeters, to increase the contact area with the small-diameter stent graft (second artificial blood vessel) to be inserted into the fenestration formed on the inner circumferential surface of the retaining ring, thereby more firmly and tightly holding the small-diameter stent graft by the retaining ring after anastomosis and reducing the risk of blood leakage.

[0035] When the fenestration of the artificial blood vessel is close to the anastomosis site in a surgical procedure, the needle may be inserted into part of the retaining ring to perform the suturing. To accommodate this, a mesh structure is provided with a through-hole in part of the collar of the retaining ring to allow the surgical needle to pass through. This makes it possible to use the retaining ring without affecting the suturing, even when it is necessary to create a fenestration close to the suture site of the artificial blood vessel.

[0036] The retaining ring also has a main body member and a washer member arranged inside and outside, and an engaging portion is provided for positioning them circumferentially (rotationally) so that the mesh structures provided on each of these members can be aligned to facilitate the passage of a surgical needle.

[0037] By using such an artificial blood vessel with a retaining ring, it is expected that the time required for catheter treatment will be shortened and the long-term survival rate of patients will be improved by reducing blood leakage.

[0038] A detailed description will be given below with reference to FIGS.

[0039] Figure 1 shows an example of hybrid treatment of an aorta with an aneurysm using the artificial blood vessel kit of the present invention, Figure 2 shows the process of attaching a retaining ring to a first artificial blood vessel, Figure 3 shows an example of a retaining ring, Figure 4 is a cross-sectional view showing the process of fixing the retaining ring, Figure 5 shows an example of a state in which the first artificial blood vessel has been sutured to another blood vessel, and Figure 6 shows the state in which a second artificial blood vessel is attached by inserting it through the fenestration portion of the first artificial blood vessel.

[0040] In FIG. 1, a patient has a disease such as an aneurysm in the aorta 5, and is being treated by hybrid surgery.

[0041] By artificial blood vessel replacement surgery under thoracotomy, the anterior portion of the aortic arch 5b, including the ascending aorta 5a, is replaced with a main artificial blood vessel 11. A small-diameter artificial blood vessel 11a connected to the brachiocephalic artery 6a and a small-diameter artificial blood vessel 11b connected to the left common carotid artery 6b are sutured to the main artificial blood vessel 11, and the distal end 11d of the main artificial blood vessel 11 is sutured to the aortic valve 5v.

[0042] The main artificial blood vessel 11 and the small-diameter artificial blood vessels 11a, 11b are cylindrically shaped and made of braided fibers made of polyester, Teflon (registered trademark), etc., and are appropriately treated to prevent blood leakage, to ensure blood compatibility, etc. The small-diameter artificial blood vessels 11a, 11b may be previously joined to the main artificial blood vessel 11, for example, one with two branches.

[0043] 1 and 2, the first artificial blood vessel 12 is tubular and can be sutured at its end to another tubular body. The first artificial blood vessel 12 is a self-expanding artificial blood vessel (stent graft), which is inserted into the blood vessel through an incision in the aortic arch 5b, expands in diameter by manipulation, and remains in place in a state of close contact with the blood vessel wall.

[0044] The size of the first artificial blood vessel 12 is selected according to the inner diameter and length of the aortic arch 5b measured in advance using CT or the like, but may be changed to a different size by observing the condition of the aortic arch 5b under thoracotomy.

[0045] The first artificial blood vessel 12 has a hole (fenestration) 21 formed in the tube wall to match the position of the origin of the left subclavian artery 6c and the opening diameter, and a retaining ring 22 that matches the size of the fenestration 21 is attached to the formed fenestration 21.

[0046] The hole 21 formed in the first artificial blood vessel 12 is for attaching a retaining ring 22 and inserting and retaining the small-diameter stent graft 13 therethrough, as will be described later. Therefore, in the following, focusing on this function, the "hole 21" may be referred to as the "fenestration portion 21." Furthermore, since the "fenestration portion 21" has the same function as the "insertion hole 51" in the retaining ring 22 in Figure 3, the "insertion hole 51" may be referred to as the "fenestration portion 21."

[0047] While inserted into the aortic arch 5b, the first artificial blood vessel 12 is adjusted in length to fit the incision in the aortic arch 5b and trimmed, and its end 12a is sutured to the incision in the aortic arch 5b to form a stoma, which is then sutured to the proximal end 11c of the main artificial blood vessel 11. Note that the order and method of joining the end 12a of the first artificial blood vessel 12, the incision in the aortic arch 5b, and the proximal end 11c of the artificial blood vessel 11 to one another is not limited to the methods described here, and various other methods or orders can be selected.

[0048] The second artificial blood vessel 13 is a self-expanding small-diameter artificial blood vessel (small-diameter stent graft) that is inserted into and left in place in the hole 21 of the first artificial blood vessel 12. Hereinafter, it may be referred to as the "small-diameter stent graft 13."

[0049] The retaining ring 22 is made of an X-ray opaque material, such as a metal material such as stainless steel, nickel, cobalt, or nitinol (nickel-titanium alloy), and is attached to the hole 21 formed in the first artificial blood vessel 12 to reinforce the peripheral portion of the hole 21.

[0050] When attached to the hole 21, the retaining ring 22 serves as a mark for catheter manipulation under X-ray fluoroscopy, allowing the small-diameter stent graft 13 to be inserted into the first artificial blood vessel 12 to pass through the hole 21 and protrude outward. The retaining ring 22 is a retaining ring that holds the small-diameter stent graft 13 at the crimped portion with the small-diameter stent graft 13 after the small-diameter stent graft 13 has been inserted (see FIG. 6 ).

[0051] 3 and 4 , the retaining ring 22 has a main body member 31 disposed on one of the inner and outer surfaces 121 of the tube wall of the first artificial blood vessel 12, and a disk-shaped washer member 32 disposed on the other surface 122. The main body member 31 has a tubular portion 41 inserted into the hole 21 and a disk-shaped flange portion 42 continuous with one end of the tubular portion 41. With the tubular portion 41 of the main body member 31 inserted through an insertion hole 51 provided in the washer member 32 ( FIG. 4(A) ), the tubular portion 41 is plastically deformed by a crimping tool, and the tip end of the tubular portion 41 is pressed against the surface of the washer member 32, thereby attaching the retaining ring 22 to the hole 21 ( FIG. 4(B) ).

[0052] The thickness of the tubular portion 41 and the flange portion 42 of the main body member 31 is approximately 0.5 to 1 mm, and the axial length of the tubular portion 41 is approximately 5 to 8 mm. The thickness of the washer member 32 is approximately 0.5 to 4 mm. If a thick-walled portion 322 is provided on the inner periphery as shown in FIG. 8, the thickness of the thin-walled portion 321 on the outer periphery can be reduced. In any case, the minimum thickness should be set to a value that ensures strength, adhesion, and stability. The inner diameter of the tubular portion 41 is determined depending on the inner diameter of the origin of the left subclavian artery 6c, and is, for example, approximately 8 to 10 mm. The outer diameter of the flange portion 42 and the washer member 32 is, for example, approximately 15 to 20 mm.

[0053] As the crimping tool, a hand press such as a pliers type or a double-sided eyelet punch, or a screw-type crimping device can be used.

[0054] The collar portion 42 and the washer member 32 are provided with fan-shaped through-holes 43a, 43b, 43c, 53a, 53b, and 53c, through which a sewing needle can pass at the same position on the wall of the first artificial blood vessel 12. These through-holes 43a-c and 53a-c are not provided around the entire circumference of the collar portion 42 and the washer member 32, but are provided only on a portion of the circumference, approximately half the circumference in the figure. This is because the end 12a of the first artificial blood vessel 12 is sutured using a sewing needle, so it is sufficient to have through-holes 43a-c and 53a-c near the end. However, providing through-holes around the entire circumference increases the degree of freedom in suturing. Note that in the example described here, there are three through-holes 43a-c and 53a-c, respectively, but they may be one, two, four, or more, and their sizes and shapes may vary.

[0055] Furthermore, one or more protrusions 41a are provided on the outer periphery of the cylindrical portion 41, and one or more grooves 51a are provided on the inner periphery of the washer member 32, and engaging portions are provided in which the protrusions 41a fit into and engage with the grooves 51a when the cylindrical portion 41 is inserted into the insertion hole 51. The engaging portions determine the circumferential positioning of the main body member 31 and the washer member 32. As a result, the through holes 43a-c and the through holes 53a-c are held in the same position, forming a mesh structure that allows the sewing needle to be easily passed through.

[0056] The protrusion 41a is provided only on the base side in the axial direction of the cylindrical portion 41, and is not provided on the tip side that will be plastically deformed by crimping. Also, an appropriate structure other than the protrusion 41 and groove 51a may be used as the engaging portion.

[0057] The inner peripheral surface of the retaining ring 22 forms a space like the inside of a chimney, and serves as or becomes a part of the landing zone at the proximal end of the small diameter stent graft 13. Therefore, as for the axial length of the retaining ring 22, that is, its thickness, it is preferable to give it an appropriate thickness, as described above, in order to improve the adhesion and bonding strength with the proximal end of the small diameter stent graft 13 and to obtain long-term stability.

[0058] In order for the retaining ring 22 to function as a marker under X-ray fluoroscopy, it is not necessary for both the main body member 31 and the washer member 32 to have this function, and this function may be provided to only one of them. For example, the main body member 31 may be made of a metal material, and the washer member 32 may be made of a material other than metal, such as a synthetic resin or ceramics that has good blood compatibility.

[0059] Furthermore, the size and position of the hole 21, the retaining ring 22, and the second artificial blood vessel 13 provided in the wall of the first artificial blood vessel 12 are selected according to the condition of the aortic arch 5b measured by CT or the like, but are ultimately determined after confirming the actual condition after thoracotomy.

[0060] In Figure 2, a device for the first artificial blood vessel 12 is prepared (Figure 2(A)), a hole 21 is drilled at a predetermined position in the vessel wall (Figure 2(B)), a retaining ring 22 is attached to the hole 21 (Figure 2(C)), the first artificial blood vessel 12 is bent to fit the shape of the aortic arch 5b (Figure 2(D)), and inserted into the blood vessel.

[0061] 5, the end 12a of the first artificial blood vessel 12 is sutured with a sewing thread 15 through the through-holes 43a-c, 53a-c, etc. of the flange 42 and the washer member 32. By sewing the sewing thread 15 through the through-holes 43a-c, 53a-c, the fixing force of the retaining ring 22 and the joining force by the suture are increased, thereby achieving further stabilization.

[0062] As shown in Figure 6, by catheter manipulation using a completely intravascular approach, the small-diameter stent graft 13 is inserted from inside the first artificial blood vessel 12 through the hole (fenestration) 21 formed by the retaining ring 22 and into the left subclavian artery 6c, where it is deployed and placed. Because the entire retaining ring 22 is radiopaque, clear visibility is obtained during catheter manipulation under X-ray fluoroscopy, making it possible to reliably insert and place the small-diameter stent graft 13 in a short period of time. Because the retaining ring 22 has an appropriate thickness, it adheres well to the proximal end of the small-diameter stent graft 13, enabling stable prevention of blood leakage over a long period of time.

[0063] In FIG. 3 , washers 33a and 33b are shown in phantom lines between the tubular wall of the first artificial blood vessel 12 and the main body member 31 and washer member 32, respectively. Washers 33a and 33b can be positioned in these positions. Washers 33a and 33b are annular disks with a thickness of approximately 0.5 to 2.0 mm, preferably approximately 1.0 mm, and are made of felt made of a synthetic resin with good blood compatibility, such as polyester or Teflon (registered trademark). When washers 33a and 33b are made of annular fabric structures, they can be penetrated by a sewing needle during suturing. However, if the washers are too thick or have a dense structure that makes it difficult to penetrate them with a sewing needle, they can be made with a mesh structure similar to that of the retaining ring 22. Washers 33a and 33b can also be made from ceramics or metal. In this case, a mesh structure similar to that of the retaining ring 22 can be used to allow penetration by a sewing needle.

[0064] 7 shows an example of the retaining ring 22A when washers 33a and 33b are used. Using washers 33a and 33b is expected to improve strength and adhesion, and is also advantageous for increasing the thickness of the retaining ring 22A to ensure a sufficient landing zone. The cylindrical portion 41A and the flange portion 42A of the main body member 31A may be thick enough to ensure strength.

[0065] 8 shows an example of a retaining ring 22B in which the required thickness is achieved without using a washer. In the retaining ring 22B, a washer member 32B is provided with a thin portion 321 and a thick portion 322, and the thick portion 322 ensures the overall thickness. The cylindrical portion 41B and the flange portion 42B of the main body member 31B may have a thickness sufficient to ensure strength.

[0066] In order to accommodate minute misalignments between the artery and the hole (fenestration) 21, the outer edge of the retaining ring 22 that comes into contact with the periphery of the hole 21 or the inner circumferential surface that comes into contact with the outer periphery of the small-diameter stent graft 13 may be made elastically deformable so as to expand or deform. For example, an elastically deformable annular spring may be attached to the outer or inner periphery of the tubular portion 41 of the retaining ring 22. In this case, although there is a possibility that adhesion and stability may be impaired, adaptability to changes in the patient's condition and characteristics is improved, and therefore, the appropriateness may be determined comprehensively.

[0067] 9 shows an example of a first artificial blood vessel 12D having two holes 21, 21 and retaining rings 22, 22. The first artificial blood vessel 12D is used, for example, when preserving the left common carotid artery 6b and the left subclavian artery 6c in the aortic arch 5b. In this way, the number and positions of the holes 21 and retaining rings 22 may be selected depending on the position, such as the zone classification, in which the first artificial blood vessel 12, 12D is to be placed.

[0068] An artificial blood vessel kit for such hybrid treatment may be prepared by combining various sizes of first artificial blood vessels 12, small-diameter stent grafts 13, retaining rings 22, and washers 33a, 33b. Furthermore, various sizes of main artificial blood vessels 11 and small-diameter artificial blood vessels 11a, 11b may also be combined. Furthermore, a crimping tool may also be prepared as an additional device and item required for the procedure.

[0069] Also, first artificial blood vessels 12 of various sizes with retaining rings 22 attached thereto may be prepared as artificial blood vessels for hybrid treatment.

[0070] The above-described embodiment provides an artificial blood vessel kit and artificial blood vessel suitable for use in hybrid treatment. Furthermore, it is possible to easily obtain landmarks for catheter manipulation in hybrid treatment, facilitating and stabilizing the insertion of the small-diameter stent graft 13 and wires. Furthermore, improved adhesion and bonding between the origin of the small-diameter stent graft 13 and the fenestration 21 reduces the risk of blood leakage, which is expected to improve the long-term survival rate of patients.

[0071] Furthermore, various sizes of first artificial blood vessels 12, small-diameter stent grafts 13, retaining rings 22, and washers 33a, 33b, etc. can be appropriately selected according to the actual condition under thoracotomy, allowing optimal surgical treatment to be performed in a short period of time, thereby reducing the physical burden on the patient.

[0072] In the above-described embodiment, the overall or individual configurations, structures, shapes, dimensions, and materials of the main artificial blood vessel 11, small-diameter artificial blood vessels 11a, 11b, first artificial blood vessel 12, 12D, small-diameter stent graft 13, retaining rings 22, 22A, 22B, washers 33a, 33b, and other equipment and tools, as well as the content, order, and timing of hybrid treatment, can be modified as appropriate in accordance with the spirit of the present invention.

[0073] DESCRIPTION OF SYMBOLS 11 Main artificial blood vessel 11a, 11b Small diameter artificial blood vessel 12, 12D First artificial blood vessel (artificial blood vessel, artificial blood vessel kit) 13 Small diameter stent graft (second artificial blood vessel, artificial blood vessel kit) 21 Hole (fenestration portion) 22, 22A, 22B Retaining ring (artificial blood vessel, artificial blood vessel kit) 31, 31A, 31B Main body member 32, 32A, 32B Washer member 33a, 33b Washer 41, 41A, 41B Cylindrical portion 42, 42A, 42B Flange portion 41a Protrusion (engagement portion) 51a Groove (engagement portion) 43a-c Through hole 53a-c Through hole

Claims

1. An artificial blood vessel kit comprising: a first artificial blood vessel that is tubular and capable of being sutured at at least one end to another tubular body; an annular retaining ring that itself contains an X-ray opaque element and that is attached to a hole in the tubular wall of the first artificial blood vessel to reinforce the periphery of the hole; and a second artificial blood vessel to be inserted into and left in place in the hole of the first artificial blood vessel, wherein the retaining ring, when attached to the hole of the first artificial blood vessel, serves as a guide for operation under X-ray fluoroscopy to insert the second artificial blood vessel into the first artificial blood vessel through the hole and project outward from the first artificial blood vessel, and also holds the second artificial blood vessel at the anastomosis portion with the second artificial blood vessel after insertion of the second artificial blood vessel.

2. An artificial blood vessel kit comprising: a first tubular artificial blood vessel to be sutured at least one end to an arterial blood vessel during thoracotomy; an annular retaining ring which itself contains an X-ray opaque element and which is attached to a hole in the tubular wall of said first artificial blood vessel to reinforce the periphery of said hole; and a second artificial blood vessel to be inserted into said hole in said first artificial blood vessel and left in place after thoracotomy, wherein when attached to the hole in said first artificial blood vessel, said retaining ring serves as a guide for operation under X-ray fluoroscopy to insert said second artificial blood vessel, which is inserted into the inside of said first artificial blood vessel by a catheter after thoracotomy, through said hole and project outward from said first artificial blood vessel, and also holds said second artificial blood vessel at the anastomosis portion with said second artificial blood vessel after insertion of said second artificial blood vessel.

3. An artificial blood vessel kit according to claim 1 or 2, wherein the retaining ring has a main body member placed on one of the inner and outer surfaces of the tube wall and a washer member placed on the other surface, the main body member having a tubular portion inserted into the hole and a flange portion continuous with one end of the tubular portion, the tubular portion of the main body member being plastically deformed and pressed against the washer member after being inserted through an insertion hole provided in the washer member, thereby attaching the retaining ring to the hole.

4. The artificial blood vessel kit according to claim 3, wherein the flange and the washer member are provided with a through-hole through which a sewing needle can pass at the same position on the tube wall.

5. The artificial blood vessel kit according to claim 4, further comprising an engaging portion for circumferentially positioning the main body member and the washer member.

6. The artificial blood vessel kit according to claim 5, wherein the engaging portion includes a protrusion provided on the outer periphery of the cylindrical portion and a groove provided on the inner periphery of the washer member into which the protrusion fits and engages.

7. The artificial blood vessel kit according to claim 3, further comprising a washer for insertion between said tube wall and said body member and said washer member.

8. An artificial blood vessel kit according to claim 1 or 2, wherein the hole is provided in the wall of the first artificial blood vessel in accordance with the position and size of the second artificial blood vessel.

9. The artificial blood vessel kit according to claim 1 or 2, wherein the retaining ring is elastically deformable so that the outer edge that contacts the peripheral edge of the hole expands or deforms.

10. An artificial blood vessel that is tubular and can be sutured to another tubular body at at least one end, characterized in that a hole formed in the tubular wall is fitted with an annular retaining ring that reinforces the periphery, the retaining ring itself containing an X-ray opaque element, and a through-hole through which a sewing needle can pass is formed on the side near the end of the artificial blood vessel.

11. The artificial blood vessel according to claim 10, wherein the retaining ring has a main body member placed on one of the inner and outer surfaces of the tube wall and a washer member placed on the other surface, the main body member having a tubular portion inserted into the hole and a flange portion continuous with one end of the tubular portion, the tubular portion of the main body member being plastically deformed and pressed against the washer member after being inserted into an insertion hole provided in the washer member, thereby attaching the retaining ring to the hole.

12. The artificial blood vessel according to claim 11, wherein a washer is inserted between the tube wall and the main body member and between the washer member and the tube wall and the main body member and the washer member.

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