WO2025203989A1 - Artificial blood vessel and artificial blood vessel kit - Google Patents

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 prostheses and vascular prosthesis kits

The present invention relates to an artificial blood vessel and an artificial blood vessel kit, which are used to treat aortic aneurysms and the like.

Aortic aneurysms are diseases that can lead to sudden death if they rupture, and are classified as true aneurysms caused by arteriosclerosis, which occur in elderly people, and dissecting aneurysms, which occur in relatively young people. Both types of aneurysms have a high mortality rate if left untreated, so prophylactic treatments are available, 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.

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. In other words, because the aortic arch runs from the anterior chest to the posterior chest, it is difficult to approach using surgical treatment alone. Furthermore, because branches to the brain (the brachiocephalic artery, left common carotid artery, and left subclavian artery) branch off from the aortic arch, it is difficult to maintain adequate cerebral blood flow using only an endovascular approach.

In recent years, therefore, hybrid treatments that combine surgical and endovascular approaches to resolve the issues of both treatments in a complementary manner are often chosen.

Special Publication 2015-527156 Special Publication 2012-501205

In hybrid treatment, 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 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.

In this intraoperative endovascular approach, a self-expanding artificial blood vessel (stent graft) is inserted and placed inside 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 its opening, thereby preserving blood flow.

However, if left in this state, blood will flow into the aneurysm through the fenestration that has been created, and the aneurysm will not be emptied. Therefore, after the chest is closed, an additional procedure will be required on a different day using a fully endovascular approach (catheter manipulation) to place a small-diameter stent graft that bridges the left subclavian artery from the fenestration. By performing this additional procedure, the posterior portion of the arch will be emptied with the stent graft, completing the treatment.

However, in the current artificial blood vessel fenestration procedure, a hole is created by simply cutting out a portion of the artificial blood vessel. As a result, when performing catheter manipulation as an additional procedure at a later date, there are no landmarks that can be recognized under X-ray fluoroscopy, making it technically difficult to insert the catheter into the fenestration. Furthermore, fenestrations created by the simple cutting method have poor adhesion to small-diameter stent grafts, and it has been pointed out that there is a certain risk that blood will leak from the connection site, allowing blood flow to the aneurysm and preventing the aneurysm from being cleared.

Furthermore, hybrid treatment requires performing extracorporeal circulation under an open chest using a heart-lung machine or other device, while ultimately determining one or more artificial blood vessels that are suitable for the condition of the aortic blood vessels and aneurysm. Then, starting with the aortic replacement surgery, fenestrations must be created in the artificial blood vessel that match the position and size of the branching blood vessels, and the artificial blood vessel must be inserted and placed within the natural blood vessel, after which it must be sutured to the surrounding natural blood vessels or other artificial blood vessels.

As a result, it is necessary to perform these operations during thoracotomy as quickly as possible to minimize the physical burden on the patient, and it is also necessary to make catheter operation easier and more reliable after the chest is closed.

In light of these issues, the present invention aims to provide an artificial blood vessel kit and artificial blood vessel that are suitable for use in hybrid treatment.

In particular, the goal is to make it easier to obtain landmarks when manipulating 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.

Furthermore, one aspect of the present invention aims to make it easier to suture artificial blood vessels with fenestrations formed in hybrid treatment, thereby expanding the range of applications for various pathologies.

An artificial blood vessel kit according to one embodiment of the present invention includes 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 is attached to a hole (fenestration) 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. When attached to the hole of the first artificial blood vessel, the retaining ring 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 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.

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 through an insertion hole provided in the washer member and pressed against the washer member, thereby attaching the retaining ring to the hole.

Furthermore, 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.

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; the protrusion fits into and engages with the groove, making it possible to position the main body member and the washer member in the circumferential direction.

Preferably, the artificial blood vessel kit includes a washer for insertion between the vessel wall and the body member and washer member.
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.

The retaining ring is elastically deformable so that its outer edge, which comes into contact with the periphery of the hole, expands or deforms.

One form of the present invention is an artificial blood vessel that is tubular and can be sutured to another tubular body at at least one end. A circular retaining ring is attached to a hole in the tubular wall to reinforce the periphery. The retaining ring itself contains an X-ray opaque element, and a through-hole is provided near the end of the artificial blood vessel through which a sewing needle can pass.

The present invention provides an artificial blood vessel kit and artificial blood vessel that are suitable for use in hybrid treatment.

In addition, it makes it easier to obtain landmarks when manipulating the catheter during hybrid treatment, and it also makes it easier to insert the stent graft from the fenestration into the branch vessel, reducing the risk of blood leakage by improving connectivity.

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 in hybrid treatment, making it possible to expand the range of application to various pathological conditions in the aorta.

FIG. 1 is a diagram showing an example of hybrid treatment of an aorta with an aneurysm using the artificial blood vessel kit according to the present invention. 10A and 10B are diagrams showing the process of attaching a retaining ring to the first artificial blood vessel. FIG. 10 is a diagram showing an example of a retaining ring. 10A and 10B are cross-sectional views showing a process of fixing the retaining ring. FIG. 10 is a diagram showing an example of a state in which the first artificial blood vessel is sutured to another blood vessel. FIG. 10 is a view showing the state in which a second artificial blood vessel is attached by passing it through the fenestration portion of the first artificial blood vessel. FIG. 10 is a diagram showing another example of a retaining ring. FIG. 10 is a diagram showing another example of a retaining ring. FIG. 10 is a diagram showing another example of the first artificial blood vessel. 1 is a flowchart showing the flow of hybrid treatment. 1 is a flowchart showing the procedure of an intraoperative endovascular approach. 1 is a flowchart showing the procedure of a completely endovascular approach.

The following describes an embodiment of the present invention.

First, hybrid treatment (hybrid surgery) in this embodiment will be explained with reference to the flowcharts shown in Figures 10 to 12.

In hybrid treatment, for example, under open 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).

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

After the first artificial blood vessel is inserted through the incision in the arch and placed inside 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.

However, if left in this state, blood will flow into the aneurysm through the created fenestration, preventing the aneurysm from being emptied. Therefore, after the chest is closed, a completely endovascular approach with the chest closed will be performed at a later date (#5).

In a fully endovascular approach, a small-diameter stent graft, which is a second artificial blood vessel, is prepared (#21), and the small-diameter stent graft is inserted through the fenestration (#23) using catheter manipulation (#22) 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.

In one embodiment of this hybrid treatment, a hole is made in a self-expanding artificial blood vessel (first artificial blood vessel) by cutting to create a fenestration, and then additional treatment is performed on the fenestration. A commercialized device can be used as this artificial blood vessel. As an additional treatment, metal retaining rings are attached to the inner and outer surfaces of the fenestration, reinforcing the edges of the fenestration.

The retaining ring serves as a marker under X-ray fluoroscopy during subsequent catheter manipulation, making it easier to insert the catheter into the fenestration. Furthermore, the retaining ring is made several millimeters thick, for example 3 to 6 millimeters, specifically 5 millimeters, to increase the contact area with the small-diameter stent graft (second artificial blood vessel) that is inserted into the fenestration formed on the inner surface of the retaining ring. This allows the retaining ring to hold the small-diameter stent graft more firmly and tightly after the two are anastomosed, reducing the risk of blood leakage.

If the fenestration in the artificial blood vessel is close to the anastomosis site in a surgical procedure, the needle may be threaded all the way through the retaining ring to close the suturing. To accommodate this, a mesh structure is created with a 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 while avoiding any impact on the suturing, even when it is necessary to create a fenestration close to the suture site of the artificial blood vessel.

The retaining ring also has a main body member and a washer member arranged inside and outside, and an engagement portion is provided for positioning the two members in the circumferential (rotational) direction so that the mesh structures on each member can be aligned to facilitate passage of the surgical needle.

The use of such artificial blood vessels with retaining rings is expected to reduce the time required for catheter treatment and improve long-term patient survival rates by reducing blood leakage.

The following provides a detailed explanation with reference to Figures 1 to 9.

Figure 1 shows an example of hybrid treatment of an aorta with an aneurysm using an artificial blood vessel kit according to 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 first artificial blood vessel sutured to another blood vessel; and Figure 6 shows the attachment of a second artificial blood vessel by inserting it through the fenestration in the first artificial blood vessel.

In Figure 1, the patient has a disease such as an aneurysm in the aorta 5, and is being treated using hybrid surgery.

Throat-open artificial blood vessel replacement surgery has been performed to replace the anterior portion of the aortic arch 5b, including the ascending aorta 5a, with a main artificial blood vessel 11. A small-diameter artificial blood vessel 11a connected to the brachiocephalic trunk 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.

The main artificial blood vessel 11 and small-diameter artificial blood vessels 11a, 11b are formed into a cylindrical shape by weaving fibers made of polyester, Teflon (registered trademark), or the like, and are appropriately treated to prevent blood leakage and to ensure blood compatibility. Small-diameter artificial blood vessels 11a, 11b may be pre-attached to the main artificial blood vessel 11, for example, one with two branches.

Referring to Figures 1 and 2, the first artificial blood vessel 12 is tubular and can be sutured to other tubular bodies at its ends. The first artificial blood vessel 12 is a self-expanding artificial blood vessel (stent graft) that is inserted into the blood vessel through an incision in the aortic arch 5b, then expanded by manipulation and left in place in a state of close contact with the blood vessel wall.

The size of the first artificial blood vessel 12 is selected based on the inner diameter and length of the aortic arch 5b, which are measured in advance using CT or other methods, but may be changed to a different size by observing the condition of the aortic arch 5b under thoracotomy.

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

The hole 21 formed in the first artificial blood vessel 12 is for attaching a retaining ring 22, as described below, and for inserting and retaining the small-diameter stent graft 13 therein. 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."

With the first artificial blood vessel 12 inserted into the aortic arch 5b, its length is adjusted and trimmed to fit the incision in the aortic arch 5b, 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 method described here, and various other methods or orders can be selected.

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."

The retaining ring 22 is made of an X-ray opaque material, such as a metallic 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 periphery of the hole 21.

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

In Figures 3 and 4, the retaining ring 22 has a main body member 31 placed 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 placed 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. The tubular portion 41 of the main body member 31 is inserted through an insertion hole 51 provided in the washer member 32 (Figure 4(A)), and is plastically deformed by a crimping tool, so that the tip 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 (Figure 4(B)).

The thickness of the tubular portion 41 and 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, and if a thick-walled portion 322 is provided on the inner peripheral side as shown in Figure 8, the thickness of the thin-walled portion 321 on the outer peripheral side can be reduced. In either case, the minimum thickness should be set to a level that ensures strength and provides 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 washer member 32 is, for example, approximately 15 to 20 mm.

In addition, pliers-type, hand presses such as double-sided eyelet punches, or screw-type crimping devices can be used as crimping tools.

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 portion 12a of the first artificial blood vessel 12 is sutured using a sewing needle, and so it is sufficient to have through-holes 43a-c and 53a-c on the end portion side. However, providing through-holes around the entire circumference would improve the degree of freedom in suturing.
In the example described here, there are three through holes 43a-c, 53a-c, but there may be one, two, or four or more through holes, and the sizes and shapes of the through holes may be different.

Furthermore, one or more protrusions 41a are provided on the outer periphery of the tubular portion 41, and one or more grooves 51a are provided on the inner periphery of the washer member 32, with engaging portions provided where the protrusions 41a fit into and engage the grooves 51a when the tubular 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. This holds the through holes 43a-c and the through holes 53a-c in the same position, forming a mesh structure that allows the sewing needle to be easily passed through.

Note that the protrusion 41a is provided only on the axial base side of the cylindrical portion 41, and not on the tip side that will be plastically deformed by crimping. Furthermore, any suitable structure other than the protrusion 41 and groove 51a may be used as the engaging portion.

The inner surface of the retaining ring 22 forms a space like the inside of a chimney, and serves as the landing zone at the base end of the small-diameter stent graft 13, or a part of it. Therefore, as mentioned above, it is preferable for the axial length, or thickness, of the retaining ring 22 to be of an appropriate thickness, in order to improve adhesion and bonding strength with the base end of the small-diameter stent graft 13 and to ensure long-term stability.

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; only one of them may have this function. 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 ceramic that has good blood compatibility.

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

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 match the shape of the aortic arch 5b (Figure 2(D)), and inserted into the blood vessel.

As shown in Figure 5, the end 12a of the first artificial blood vessel 12 is sutured with 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 of the sutures are increased, providing further stability.

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

In Figure 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 between the tubular wall of the first artificial blood vessel 12 and the washer member 32. 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 in this state. However, if the washers are too thick or have a dense structure that makes it difficult to penetrate them with a sewing needle, they may be made of a mesh structure similar to that of retaining ring 22.
The washers 33a and 33b can also be made of ceramics or metal, etc. In this case, they may have a mesh structure similar to that of the retaining ring 22 so that the sewing needle can be passed through them.

Figure 7 shows an example of a 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 flange portion 42A of the main body member 31A need only be thick enough to ensure strength.

Figure 8 shows an example of a retaining ring 22B that achieves thickness without using a washer. In the retaining ring 22B, a washer member 32B has a thin portion 321 and a thick portion 322, and the thick portion 322 ensures the overall thickness. The cylindrical portion 41B and flange portion 42B of the main body member 31B only need to be thick enough to ensure strength.

Furthermore, in order to allow the retaining ring 22 to accommodate minute misalignments between the artery and the hole (fenestration) 21, the outer edge that comes into contact with the periphery of the hole 21 or the inner 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, there is a possibility that adhesion and stability may be compromised, but adaptability to changes in the patient's condition and characteristics is improved, so it may be appropriate after making a comprehensive judgment.

Figure 9 shows an example of a first artificial blood vessel 12D with 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 can be selected depending on the position, such as the zone classification, in which the first artificial blood vessels 12, 12D are to be placed.

In addition, an artificial blood vessel kit for such hybrid treatment can be prepared by combining and setting 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 can also be combined. Additionally, a crimping tool can be prepared as an additional piece of equipment and supplies required for the procedure.

In addition, first artificial blood vessels 12 of various sizes with retaining rings 22 attached may be prepared as artificial blood vessels for hybrid treatment.

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 when performing 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.

Furthermore, various sizes of first artificial blood vessels 12, small-diameter stent grafts 13, retaining rings 22, and washers 33a, 33b can be selected appropriately 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.

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, sequence, and timing of hybrid treatment, can be modified as appropriate in accordance with the spirit of the present invention.

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)
22, 22A, 22B Retaining ring (artificial blood vessel, artificial blood vessel kit)
31, 31A, 31B Main body members 32, 32A, 32B Washer members 33a, 33b Washers 41, 41A, 41B Cylindrical portions 42, 42A, 42B Flange portion 41a Protrusion (engagement portion)
51a Groove (engaging part)
43a-c Through holes 53a-c Through holes

Claims (12)

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, the retaining ring itself including a radiopaque element, for being attached to a hole provided in a tube wall of the first artificial blood vessel and for reinforcing a peripheral portion of the hole;
a second artificial blood vessel to be inserted into the hole of the first artificial blood vessel and placed therein;
Including,
When the retaining ring is attached to the hole of the first artificial blood vessel, the retaining ring serves as a guide for an operation under X-ray fluoroscopy to insert the second artificial blood vessel, which is inserted into the inside of the first artificial blood vessel, through the hole and project outward from the first artificial blood vessel, and also serves to hold the second artificial blood vessel at the anastomosis portion with the second artificial blood vessel after the second artificial blood vessel is inserted.
An artificial blood vessel kit characterized by: a first artificial blood vessel having a tubular shape and to be sutured at least one end to an arterial blood vessel during thoracotomy;
an annular retaining ring, the retaining ring itself including a radiopaque element, for being attached to a hole provided in a tube wall of the first artificial blood vessel and for reinforcing a peripheral portion of the hole;
a second artificial blood vessel to be inserted into the hole of the first artificial blood vessel and left in place after closure of the chest;
Including,
When attached to the hole of the first artificial blood vessel, the retaining ring serves as a guide for an operation under X-ray fluoroscopy to insert the second artificial blood vessel, which is inserted into the inside of the first artificial blood vessel by a catheter after closing the chest, through the hole and project outward from the first artificial blood vessel, and also serves to hold the second artificial blood vessel at the anastomosis portion with the second artificial blood vessel after the second artificial blood vessel is inserted.
An artificial blood vessel kit characterized by: The retaining ring has a body member disposed on one of the inner and outer surfaces of the pipe wall and a washer member disposed on the other surface,
The main body member has a tubular portion inserted into the hole and a flange portion continuous with one end of the tubular portion, and after the tubular portion of the main body member is inserted into an insertion hole provided in the washer member, it is plastically deformed and pressed against the washer member, thereby attaching the retaining ring to the hole.
3. The artificial blood vessel kit according to claim 1 or 2. The flange and the washer member are provided with through-holes at the same positions on the pipe wall through which a sewing needle can pass.
The artificial blood vessel kit according to claim 3. An engagement portion is provided for positioning the main body member and the washer member in the circumferential direction.
The artificial blood vessel kit according to claim 4. The engaging portion includes a protrusion provided on an outer periphery of the cylindrical portion and a groove provided on an inner periphery of the washer member into which the protrusion fits and engages.
The artificial blood vessel kit according to claim 5. a washer for insertion between said tube wall and said body member and said washer member;
The artificial blood vessel kit according to claim 3. The hole is provided in the vascular wall of the first artificial blood vessel in accordance with the position and size of the second artificial blood vessel.
3. The artificial blood vessel kit according to claim 1 or 2. The retaining ring is elastically deformable so that an outer edge that contacts the peripheral edge of the hole expands or deforms.
3. The artificial blood vessel kit according to claim 1 or 2. An artificial blood vessel having a tubular shape and capable of being sutured to another tubular body at at least one end,
The hole in the pipe wall is fitted with an annular retaining ring to reinforce the periphery.
The retaining ring itself includes an X-ray opaque element, and has a through hole through which a sewing needle can pass on the side close to the end of the artificial blood vessel.
An artificial blood vessel characterized by: The retaining ring has a body member disposed on one of the inner and outer surfaces of the pipe wall and a washer member disposed on the other surface,
The main body member has a tubular portion inserted into the hole and a flange portion continuous with one end of the tubular portion, and after the tubular portion of the main body member is inserted into the insertion hole provided in the washer member, it is plastically deformed and pressed against the washer member, thereby attaching the retaining ring to the hole.
The artificial blood vessel according to claim 10. a washer is inserted between the pipe wall and the body member and the washer member;
The artificial blood vessel according to claim 11.