Vascular prosthesis and vascular prosthesis kit

Abstract

The present application provides an artificial blood vessel kit and an artificial blood vessel which can preferably be used for mixed treatment, comprising: a first artificial blood vessel 12 which is tubular and capable of being sutured with other tubular bodies at least at one end; a ring-shaped fixing ring 22 which is installed in a hole (window portion) 21 provided in the tube wall of the first artificial blood vessel and itself contains an X-ray non-transmissive element; and a second artificial blood vessel 13 which is inserted into the hole of the first artificial blood vessel. The fixing ring 22 serves as an identifier for operation under X-ray fluoroscopy, and holds the second artificial blood vessel at the anastomosis portion after the second artificial blood vessel is threaded.

Description

Technical Field

[0001] This invention relates to an artificial blood vessel and an artificial blood vessel kit for the treatment of aortic aneurysms, etc. Background Technology

[0002] Aortic aneurysms are diseases that can lead to sudden death if they rupture. They can be classified into true aneurysms caused by arteriosclerosis in the elderly and others, and dissecting aneurysms that occur in relatively young people. In both types, the mortality rate is high if left untreated. Therefore, prophylactic treatments include surgical resection of the aneurysm and replacement with an artificial blood vessel, or placement of a self-expanding artificial blood vessel (stent graft) via an endovascular approach to block blood flow to the aneurysm (i.e., aneurysm isolation). Examples of endovascular approaches are shown in Patent Documents 1 and 2.

[0003] However, the difficulty and risks of these treatments vary considerably depending on the location of the aortic aneurysm, especially for those located in the aortic arch, where the risks are known to be higher. This is primarily due to the anatomical characteristics of the aortic arch. Specifically, because the aortic arch extends from the anterior chest to the dorsal chest, surgical approaches alone are often difficult to implement. Furthermore, the presence of branches from the aortic arch that lead to the brain (brachial artery, left common carotid artery, left subclavian artery) makes it challenging to adequately maintain cerebral blood flow via endovascular approaches alone.

[0004] Therefore, in recent years, hybrid treatments that combine surgical and endovascular approaches have been frequently chosen to address the problems of both treatments in a complementary manner.

[0005] Background Technology Documents [Patent Literature] Patent Document 1: Japanese Patent Application No. 2015-527156.

[0006] Patent Document 2: Japanese Patent Application No. 2012-501205. Summary of the Invention

[0007] [The problem the invention aims to solve] In mixed treatment, the following method is first performed: the anterior part of the aortic arch, such as the ascending aorta, brachiocephalic artery, and left common carotid artery, which are relatively easy to access surgically, is replaced with artificial blood vessels. Then, the posterior part of the arch, such as the left subclavian artery and descending aorta, is isolated intraoperatively using an endovascular approach.

[0008] In this intravascular approach, a self-expanding prosthetic blood vessel (stent graft) is inserted and placed into the descending aorta through the anterior portion of the aortic arch. For the left subclavian artery, blood flow can be preserved by creating a fenestration in the self-expanding prosthetic blood vessel corresponding to its opening.

[0009] However, while maintaining this state, the tumor is not isolated because blood can flow into it through the created fenestration. Therefore, after chest closure, a separate, scheduled procedure is required via a fully endovascular approach (catheter procedure) to place a small-diameter stent graft bridging the left subclavian artery through this fenestration. This additional procedure isolates the posterior portion of the arch with the stent graft, thus completing the treatment.

[0010] However, current fenestration techniques for artificial blood vessels only involve removing a portion of the artificial blood vessel to create an opening. Therefore, when performing catheterization as a subsequent treatment, there are no fluoroscopic markers, making catheter insertion into the fenestrated area difficult. Furthermore, the poor adhesion between the fenestrated area created by simple resection and the small-diameter stent graft has been identified, indicating a risk of blood leakage from the adhesion site, leading to residual blood flow towards the tumor and preventing tumor isolation.

[0011] In addition, in the mixed treatment, in the open-chest state, extracorporeal circulation is performed using extracorporeal life support, and at the same time, one or more artificial blood vessels corresponding to the state of the aorta or aneurysm are finally determined. The following operations are required: first, the aorta is replaced with an artificial blood vessel; then, a window is formed in the artificial blood vessel corresponding to the position and size of the branch blood vessel; and after it is inserted and left in the biological blood vessel, it is sutured to the surrounding biological blood vessels or other artificial blood vessels.

[0012] Therefore, these procedures should be performed as quickly as possible in the open-chest state to minimize the burden on the patient's body, while also making catheterization easier and more reliable after the chest is closed.

[0013] In view of these issues, the object of the present invention is to provide an artificial blood vessel kit and artificial blood vessel that can be preferably used for mixed therapy.

[0014] In particular, the aim is to facilitate easy identification during catheter manipulation in mixed therapy and to reduce the risk of blood leakage by improving the ease and accessibility of inserting stent grafts into branch vessels from the fenestration.

[0015] In another aspect of the invention, the objective is to make it easier to suture artificial blood vessels with fenestrated openings in mixed treatments and to expand the applicability to various pathological conditions.

[0016] [Methods used to solve problems] One embodiment of the artificial blood vessel kit of the present invention includes: a first artificial blood vessel that is tubular and capable of being sutured to other tubular bodies at least at one end; a ring-shaped retaining ring installed in a hole (window portion) disposed in the wall of the first artificial blood vessel, for reinforcing the periphery of the hole and itself containing an X-ray non-transmissive element; and a second artificial blood vessel to be inserted into and left in the hole of the first artificial blood vessel, wherein, when installed in the hole of the first artificial blood vessel, the retaining ring serves as an identifier for operation under X-ray fluoroscopy to allow the second artificial blood vessel (e.g., a stent graft) inserted into the interior of the first artificial blood vessel to pass through the hole and protrude to the exterior of the first artificial blood vessel, and after the second artificial blood vessel has passed through, the retaining ring holds the second artificial blood vessel at the anastomosis portion with the second artificial blood vessel.

[0017] Preferably, the retaining ring has a body member disposed on one side of the inner and outer surfaces of the pipe wall, and a washer member disposed on the other side. The body member has a cylindrical portion that passes through the hole and a flange portion that continues to one end of the cylindrical portion. After the cylindrical portion of the body member passes through the through hole provided in the washer member, it is plastically deformed and pressed against the washer member, thereby installing the retaining ring in the hole.

[0018] In addition, the flange portion and the washer component are provided with through holes for the sewing needle to pass through at the same position in the tube wall.

[0019] In addition, a protrusion is provided on the outer periphery of the cylindrical part, and a groove is provided on the inner periphery of the washer member. By inserting the protrusion into and engaging with the groove, the circumferential positioning of the body member and the washer member can be performed.

[0020] Preferably, the artificial blood vessel kit includes a gasket for insertion between the tube wall and the body component and the gasket component.

[0021] The hole is provided in the wall of the first artificial blood vessel according to the position and size of the second artificial blood vessel.

[0022] The retaining ring is elastically deformable, so that the outer edge in contact with the periphery of the hole expands or deforms.

[0023] One aspect of the artificial blood vessel of the present invention is a tubular artificial blood vessel that can be sutured to other tubular bodies at least at one end. Furthermore, an annular fixing ring for reinforcing the periphery of the hole is installed in a hole provided in the tube wall. The fixing ring itself contains an X-ray non-transmissive element and has a through hole on one side near the end of the artificial blood vessel for a suture needle to pass through.

[0024] [The effects of the invention] According to the present invention, it is possible to provide an artificial blood vessel kit and an artificial blood vessel that can be preferably used for mixed therapy.

[0025] In addition, it allows for easy identification during catheter manipulation in mixed therapy, and it can be sought to reduce the risk of blood leakage by improving the ease and accessibility of inserting stent grafts into branch vessels from the fenestration.

[0026] Furthermore, according to one embodiment of the invention, in mixed treatment, suturing of the artificial blood vessel (first artificial blood vessel) with the fenestrated portion becomes easier and expands the applicability to various pathological conditions in the aorta. Attached Figure Description

[0027] Figure 1 A figure illustrating an example of the state following a combined treatment of an aorta with an aneurysm using the artificial blood vessel kit of the present invention.

[0028] Figure 2 A diagram illustrating the process of installing a fixation ring onto the first artificial blood vessel.

[0029] Figure 3 A diagram illustrating an example of a fixed ring.

[0030] Figure 4 This is a cross-sectional view showing the process of fixing the retaining ring.

[0031] Figure 5 This figure illustrates an example of the state after the first artificial blood vessel is sutured to other blood vessels.

[0032] Figure 6 The diagram shows the opening through which the first artificial blood vessel is inserted and the appearance of the second artificial blood vessel being installed.

[0033] Figure 7 A diagram illustrating another example of a fixed ring.

[0034] Figure 8 A diagram illustrating another example of a fixed ring.

[0035] Figure 9 A diagram illustrating another example of the first artificial blood vessel.

[0036] Figure 10This is a flowchart illustrating the process of mixed therapy.

[0037] Figure 11 This is a flowchart illustrating the process of intraoperative endovascular access.

[0038] Figure 12 This is a flowchart illustrating the process of a fully endovascular approach. Detailed Implementation

[0039] The embodiments of the present invention will be described below.

[0040] First, refer to Figures 10 to 12 The flowchart shown illustrates the mixed treatment (mixed surgery) in this embodiment.

[0041] In mixed treatments, for example, in an open-chest state (#1), the anterior portion of the aortic arch, such as the ascending aorta, brachiocephalic artery, and left common carotid artery, which are relatively easy to access surgically, is replaced with an artificial blood vessel (the main artificial blood vessel) (#2), while the posterior portion of the arch, such as the left subclavian artery and descending aorta, is isolated intraoperatively using an endovascular approach (#3).

[0042] In this intravascular approach, with the chest open, a self-expanding artificial blood vessel (first artificial blood vessel) (#11) is prepared. A hole (fenestration) (#12) is formed in the wall of the first artificial blood vessel according to the opening of the left subclavian artery. A fixation ring (#13) matching the size of the fenestration is installed in the formed fenestration.

[0043] After inserting the first artificial blood vessel through the incision in the arch and placing it within the descending aorta (#14), the end of the first artificial blood vessel is sutured to the incision in the arch to form an anastomosis, and this anastomosis (stoma) is further sutured end-to-end to the main artificial blood vessel (#15). Subsequently, the chest is closed (#4). Because the first artificial blood vessel positioned in the arch has a fenestration, blood flow is preserved.

[0044] However, while maintaining this state, the tumor will not be isolated because blood will flow into it through the created fenestration. Therefore, a fully endovascular approach with the chest closed will be performed on a separate day (#5).

[0045] In the fully endovascular approach, a small-diameter stent graft (#21) is prepared as a second artificial blood vessel. The graft is inserted through a catheter (#22) into the fenestration (#23), and the left subclavian artery is reconstructed by placement (#24). The posterior portion of the arch is thus isolated by the artificial blood vessel, completing the treatment.

[0046] In this hybrid treatment, in one embodiment described herein, after creating a fenestration by excision in the self-expanding artificial blood vessel (first artificial blood vessel), the fenestration is further processed. A commercially available device can be used as the artificial blood vessel. As an additional processing step, metal retaining rings are clamped and installed from the inner and outer sides of the fenestration, thereby reinforcing the edges of the fenestration.

[0047] During subsequent catheterization procedures, the fixation ring serves as a marker under X-ray fluoroscopy, facilitating catheter insertion into the fenestration. Furthermore, the fixation ring's thickness of several millimeters, for example 3-6 millimeters, specifically approximately 5 millimeters, increases the contact area with the small-diameter stent graft (second artificial blood vessel) inserted into the fenestration formed on the inner circumferential surface of the fixation ring. This allows for a more secure and tighter hold of the small-diameter stent graft by the fixation ring after anastomosis, thereby reducing the risk of blood leakage.

[0048] When the fenestration of an artificial blood vessel is located near the surgical anastomosis, it is sometimes sutured to a portion of the fixation ring. To address this, a mesh structure is created by providing through-holes for the surgical needle to pass through a portion of the flange of the fixation ring. Thus, even when the fenestration needs to be located near the suture site of the artificial blood vessel, the fixation ring can be used without affecting the suture.

[0049] In addition, the retaining ring has a body component and a washer component disposed on the inner and outer sides, and is provided with a locking part for positioning each other in the circumferential (rotational direction) so that the mesh structure respectively provided on these components is consistent, thereby making it easy for the surgical needle to pass through.

[0050] By using this artificial blood vessel with a fixation ring, it is expected that catheter treatment time will be shortened and long-term patient survival will be improved by reducing blood leakage.

[0051] The following is for reference Figures 1 to 9 Please provide a detailed explanation.

[0052] Figure 1 The figure illustrates an example of the state following a combined treatment of an aorta with an aneurysm using the artificial blood vessel kit of the present invention. Figure 2 The diagram illustrates the process of installing the fixation ring onto the first artificial blood vessel. Figure 3 The diagram illustrates an example of a fixed ring. Figure 4 This is a cross-sectional view showing the process of fixing the retaining ring. Figure 5 The image illustrates an example of the state after the first artificial blood vessel is sutured to other blood vessels. Figure 6 The diagram shows the opening through which the first artificial blood vessel is inserted and the appearance of the second artificial blood vessel being installed.

[0053] exist Figure 1 In this case, the patient had aneurysm and other diseases in the aorta 5 and was treated with a mixed surgery.

[0054] Through open-chest artificial blood vessel replacement surgery, the anterior portion of the aortic arch 5b, including the ascending aorta 5a, is replaced with the 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.

[0055] The main artificial blood vessel 11 and the small-diameter artificial blood vessels 11a and 11b are formed into a cylindrical shape by weaving fibers made of polyester, Teflon (registered trademark), etc., and are appropriately treated to prevent blood leakage or to achieve blood compatibility. Artificial blood vessels, such as those with two branches, can also be used, where the small-diameter artificial blood vessels 11a and 11b are pre-attached to the main artificial blood vessel 11.

[0056] Reference Figure 1 and Figure 2 The first artificial blood vessel 12 is tubular and can be sutured to other tubular bodies at its end. The first artificial blood vessel 12 is a self-expanding artificial blood vessel (stent graft). After being inserted into the blood vessel through an incision in the aortic arch 5b, its diameter is expanded by manipulation and it is left in place in close contact with the blood vessel wall.

[0057] The size of the first artificial blood vessel 12 is selected based on the inner diameter and length of the aortic arch 5b as measured in advance by CT or other means, but sometimes it is changed to a different size by observing the state of the aortic arch 5b in an open-chest state.

[0058] In the first artificial blood vessel 12, a hole (window) 21 is formed in the vessel wall according to the position and opening diameter of the starting part of the left subclavian artery 6c, and a fixing ring 22 matching the size of the window 21 is installed in the formed window 21.

[0059] Furthermore, as described later, the hole 21 formed in the first artificial blood vessel 12 is used to install the fixation ring 22 and to allow the small-diameter stent graft 13 to pass through and remain there. Therefore, in view of this function, the "hole 21" will sometimes be referred to as "window portion 21". Additionally, since the "window portion 21" has a similar function to... Figure 3 It has the same function as the "through hole 51" in the fixing ring 22, therefore, the "through hole 51" is sometimes referred to as "window part 21".

[0060] With the first artificial blood vessel 12 inserted into the aortic arch 5b, its length is adjusted and trimmed according to the incision in the aortic arch 5b. Its end 12a is then sutured to the incision in the aortic arch 5b to form an anastomosis, which is then sutured to the proximal end 11c of the main artificial blood vessel 11. Furthermore, 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 main artificial blood vessel 11 are not limited to the methods described herein; various other methods or sequences may be selected.

[0061] The second artificial blood vessel 13 is a self-expanding small-diameter artificial blood vessel (small-diameter stent graft), which is inserted into and left in the hole 21 of the first artificial blood vessel 12. Hereinafter, it is sometimes referred to as "small-diameter stent graft 13".

[0062] The fixing ring 22 is made of an X-ray non-transmissive material, such as stainless steel, nickel, cobalt, nickel-titanium alloy, etc., and is installed in the hole 21 formed in the first artificial blood vessel 12 to reinforce the periphery of the hole 21.

[0063] When installed in the hole 21, the retaining ring 22 serves as a marker for catheter operation under X-ray fluoroscopy, allowing the small-diameter stent graft 13, inserted into the first artificial blood vessel 12, to pass through the hole 21 and protrude to the outside. The retaining ring 22 is a retaining ring that holds the small-diameter stent graft 13 in place at the crimped portion after insertion (see reference). Figure 6 ).

[0064] exist Figure 3 and Figure 4 In the middle, the fixing ring 22 has a body member 31 disposed on one side 121 of the inner and outer surfaces of the wall of the first artificial blood vessel 12, and a disc-shaped washer member 32 disposed on the other side 122. The body member 31 has a cylindrical portion 41 that passes through the hole 21, and a disc-shaped flange portion 42 that continues to one end of the cylindrical portion 41. In the state where the cylindrical portion 41 of the body member 31 passes through the through hole 51 provided in the washer member 32 ( Figure 4 (A)), through plastic deformation using a riveting tool, the front end of the cylindrical portion 41 is pressed against the surface of the washer member 32, thereby installing the retaining ring 22 into the hole 21 ( Figure 4 (B)).

[0065] The thickness of the cylindrical portion 41 and the flange portion 42 of the body component 31 is approximately 0.5–1 mm, and the axial length of the cylindrical portion 41 is approximately 5–8 mm. The thickness of the washer component 32 is approximately 0.5–4 mm. Figure 8When a thick-walled portion 322 is provided on the inner circumferential side, the thickness of the thin-walled portion 321 on the outer circumferential side can be reduced. In any case, the minimum thickness is sufficient to ensure strength and achieve a tight seal and stability. Furthermore, the inner diameter of the cylindrical portion 41 is determined based on the inner diameter of the origin of the left subclavian artery 6c, and is, for example, approximately 8 to 10 mm. The outer diameters of the flange portion 42 and the washer member 32 are, for example, approximately 15 to 20 mm.

[0066] In addition, as a riveting tool, manual crimping tools such as pliers, double-sided eyelet punching pliers, or threaded riveting devices can be used.

[0067] The flange portion 42 and the washer member 32 are provided with fan-shaped through holes 43a, 43b, 43c, 53a, 53b, and 53c, which allow a suture needle to pass through at the same position in the wall of the first artificial blood vessel 12. These through holes 43a-43c and 53a-53c are not provided throughout the entire circumference of the flange portion 42 and the washer member 32, but only within 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 suture needle; therefore, it is sufficient to have through holes 43a-43c and 53a-53c only on the end side. However, providing through holes throughout the entire circumference increases the degree of freedom during suture.

[0068] Furthermore, in the example described here, there are three through holes 43a-43c and 53a-53c respectively, but there may also be one, two, or more than four, and their size and shape may also be different.

[0069] 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. When the cylindrical portion 41 passes through the through hole 51, the protrusions 41a are embedded and engaged in the engaging portion of the groove 51a. The engaging portion circumferentially positions the body member 31 and the washer member 32. As a result, the through holes 43a-43c and 53a-53c are kept in the same position to form a mesh structure, thereby allowing the sewing needle to pass through easily.

[0070] Furthermore, the protrusion 41a is only provided on the axial base side of the cylindrical portion 41, and not on the front end side where plastic deformation occurs through riveting. Alternatively, suitable structures other than the protrusion 41a and the groove 51a may be used as the engaging part.

[0071] The inner circumferential surface of the fixing ring 22 forms a space similar to the inside of a chimney, which either becomes or constitutes a landing zone for the base end of the small-diameter scaffold graft 13, or forms part of it. Therefore, as described above, regarding the axial length, i.e. the thickness, of the fixing ring 22, it is preferable to give it an appropriate thickness to improve the tightness and bonding force with the base end of the small-diameter scaffold graft 13 and to obtain long-term stability.

[0072] Furthermore, to enable the retaining ring 22 to function as an identifier under X-ray fluoroscopy, it is not necessary for both the body component 31 and the gasket component 32 to have this function; only one of them may be required. For example, the body component 31 may be made of a metallic material, while the gasket component 32 may be made of a material other than a metallic material, such as a blood-compatible synthetic resin or ceramic.

[0073] In addition, the size and position of the hole 21, the fixing ring 22 and the second artificial blood vessel 13 in the wall of the first artificial blood vessel 12 can be selected based on the state of the aortic arch 5b measured by CT or the like, but the final decision is made by confirming the actual state through open-chest surgery.

[0074] exist Figure 2 In the middle, the device for preparing the first artificial blood vessel 12 ( Figure 2 (A)), a hole 21 is made at a specified position on the pipe wall. Figure 2 (B) Install the retaining ring 22 in hole 21. Figure 2 (C)), so that the first artificial blood vessel 12 is curved to match the shape of the aortic arch 5b ( Figure 2 (D)), and inserted into the blood vessel.

[0075] like Figure 5 As shown, at the end 12a of the first artificial blood vessel 12, sutures are made using sutures 15 through the through holes 43a-43c, 53a-53c of the flange portion 42 and the washer member 32. The sutures 15 pass through the through holes 43a-43c, 53a-53c to perform the suturing, thereby increasing the fixing force of the fixing ring 22 and the joint force generated by the suturing, thus achieving further stabilization.

[0076] like Figure 6As shown, through catheter manipulation via a fully endovascular approach, the small-diameter stent graft 13 is inserted through the interior of the first artificial blood vessel 12 into the opening (fenestration) 21 formed by the fixation ring 22, and then inserted, unfolded, and left inside the left subclavian artery 6c. Because the fixation ring 22 is radiopaque, clear visualization of the catheter manipulation under X-ray fluoroscopy is achieved, allowing for reliable insertion and placement of the small-diameter stent graft 13 within a short time. The appropriate thickness of the fixation ring 22 improves the tightness of contact with the base of the small-diameter stent graft 13 and provides long-term, stable prevention of blood leakage.

[0077] In addition, Figure 3 In the diagram, pads 33a and 33b are indicated by imaginary lines (double-dotted lines) between the wall of the first artificial blood vessel 12 and each of the body member 31 and the gasket member 32. Pads 33a and 33b can be positioned at this location. Pads 33a and 33b are annular discs with a thickness of approximately 0.5 to 2.0 mm, preferably approximately 1.0 mm, and are made of a felt composed of a synthetic resin with good blood compatibility, such as polyester or Teflon (registered trademark). Thus, when pads 33a and 33b are made of a fabric annular structure, even in this state, the suture needle can penetrate during suturing. However, if the needle has difficulty penetrating due to a larger thickness or a denser structure, a mesh structure similar to that in the case of the fixing ring 22 can be used.

[0078] Alternatively, the gaskets 33a and 33b can also be made of ceramic or metal. In this case, to allow the needle to pass through, it is sufficient to make a mesh structure similar to that in the case of the retaining ring 22.

[0079] Figure 7 An example of the retaining ring 22A when using gaskets 33a and 33b is disclosed. When using gaskets 33a and 33b, improved strength and tightness can be expected. Furthermore, increasing the thickness of the retaining ring 22A helps ensure a sufficient landing area. The cylindrical portion 41A and the flange portion 42A of the body member 31A only need to be of sufficient thickness to ensure strength.

[0080] Figure 8 An example of a retaining ring 22B that achieves thickness without the use of a gasket is disclosed. In the retaining ring 22B, a thin-walled portion 321 and a thick-walled portion 322 are provided in the washer member 32B, and the overall thickness is ensured by the thick-walled portion 322. The cylindrical portion 41B and the flange portion 42B of the body member 31B only need to have a thickness sufficient to ensure strength.

[0081] Furthermore, in order to accommodate minor deviations in the position of the artery and the orifice (fenestration) 21, the outer edge of the fixation ring 22 that contacts the periphery of the orifice 21, or the inner circumferential surface that contacts the periphery of the small-diameter stent graft 13, can be made elastically deformable to expand or deform. For example, an elastically deformable annular spring can be pre-installed on the outer or inner circumference of the cylindrical portion 41 of the fixation ring 22. In this case, although there is a possibility of impairing the tightness or stability, it can be applied comprehensively because it can improve the adaptability to the patient's pathological state or changes in nature.

[0082] Figure 9 An example of a first artificial blood vessel 12D with two holes 21, 21 and fixing rings 22, 22 is disclosed. The first artificial blood vessel 12D is used, for example, to preserve the left common carotid artery 6b and the left subclavian artery 6c in the aortic arch 5b. In this way, the number and position of the holes 21 and fixing rings 22 can be selected according to the zone classification and other positions of the first artificial blood vessels 12, 12D.

[0083] Furthermore, as an artificial blood vessel kit for this hybrid treatment, it is only necessary to combine various sizes of the first artificial blood vessel 12, the small-diameter stent graft 13, the fixation ring 22, and the spacers 33a and 33b into a kit. Moreover, it is also possible to combine various sizes of the main artificial blood vessel 11 and the small-diameter artificial blood vessels 11a and 11b. Additionally, riveting tools can be prepared as additional equipment and materials required for the surgical procedure.

[0084] Alternatively, first artificial blood vessels 12 of various sizes, equipped with fixing rings 22, can be prepared in advance as artificial blood vessels for mixed treatment.

[0085] According to the above embodiments, an artificial blood vessel kit and artificial blood vessel that can be preferably used for hybrid therapy can be provided. Furthermore, in hybrid therapy, identification during catheter manipulation can be easily obtained, and the insertion of the small-diameter stent graft 13 and guidewire can be facilitated and stabilized. Additionally, by improving the tightness and engagement between the initiation portion and the fenestration portion 21 of the small-diameter stent graft 13, the risk of blood leakage can be reduced, thus potentially improving the long-term survival rate of patients.

[0086] In addition, depending on the actual condition under open-chest surgery, various sizes of first artificial blood vessels 12, small-diameter stent grafts 13, fixation rings 22, and pads 33a and 33b can be appropriately selected, and the best surgical treatment can be performed in a short time, thus reducing the burden on the patient's body.

[0087] In the above embodiments, the overall or individual parts of the main artificial blood vessel 11, small-diameter artificial blood vessels 11a, 11b, first artificial blood vessels 12, 12D, small-diameter stent graft 13, fixation rings 22, 22A, 22B, pads 33a, 33b, other equipment and tools, etc., can be appropriately modified according to the purpose of this invention.

[0088] [Symbol Explanation] 11: Main artificial blood vessel 11a, 11b: Small-diameter artificial blood vessels 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 (window opening) 22, 22A, 22B: Fixation rings (artificial blood vessels, artificial blood vessel kits) 31, 31A, 31B: Body components 32, 32A, 32B: Washer components 33a, 33b: Gaskets 41, 41A, 41B: Cylindrical section 42, 42A, 42B: Flange portion 41a: Protrusion (interlocking part) 51a: Groove (Matching Part) 43a~43c: Through holes 53a~53c: Through holes

Claims

1. An artificial blood vessel kit, characterized in that... Include: A first artificial blood vessel that is tubular in shape and capable of being sutured to other tubular bodies at least at one end; An annular retaining ring, which is installed in a hole in the wall of the first artificial blood vessel to reinforce the periphery of the hole and which itself contains an X-ray-non-transmissive element; and A second artificial blood vessel should be inserted and left in the hole of the first artificial blood vessel, and, When the first artificial blood vessel is installed in the hole, the retaining ring serves as a marker for operation under X-ray fluoroscopy, allowing the second artificial blood vessel, which is inserted into the interior of the first artificial blood vessel, to pass through the hole and protrude to the exterior of the first artificial blood vessel, and after the second artificial blood vessel is inserted, to retain the second artificial blood vessel at the anastomosis portion with the second artificial blood vessel.

2. An artificial blood vessel kit, characterized in that... Include: The first artificial blood vessel is tubular and should be sutured to an artery at least at one end during thoracotomy. An annular retaining ring, which is installed in a hole in the wall of the first artificial blood vessel to reinforce the periphery of the hole and which itself contains an X-ray-non-transmissive element; and After chest closure, a second artificial blood vessel should be inserted and left in the opening of the first artificial blood vessel, and, When the first artificial blood vessel is installed in the hole, the retaining ring serves as an indicator for operation under X-ray fluoroscopy, allowing the second artificial blood vessel, which is inserted into the interior of the first artificial blood vessel by a catheter after chest closure, to pass through the hole and protrude to the exterior of the first artificial blood vessel, and after the second artificial blood vessel is inserted, to be retained at the anastomosis portion with the second artificial blood vessel.

3. The artificial blood vessel kit as described in claim 1 or 2, characterized in that: The retaining ring has a body component disposed on one side of the inner and outer surfaces of the pipe wall, and a washer component disposed on the other side. The body component has a cylindrical portion that passes through the hole and a flange portion that continues to one end of the cylindrical portion. After the cylindrical portion of the body component passes through the through hole provided in the washer component, it is plastically deformed and pressed against the washer component, thereby installing the retaining ring in the hole.

4. The artificial blood vessel kit as described in claim 3, characterized in that: The flange portion and the washer component are provided with through holes for the sewing needle to pass through at the same position in the tube wall.

5. The artificial blood vessel kit as described in claim 4, characterized in that: The device is provided with a locking part for circumferential positioning of the body component and the washer component.

6. The artificial blood vessel kit as described in claim 5, characterized in that: The engaging portion includes: a protrusion disposed on the outer periphery of the cylindrical portion, and a groove disposed on the inner periphery of the washer member for the protrusion to be inserted and engaged.

7. The artificial blood vessel kit as described in claim 3, characterized in that... Include: Gaskets used for insertion between the pipe wall and the body component and the washer component.

8. The artificial blood vessel kit as described in claim 1 or 2, characterized in that: The hole is provided in the wall of the first artificial blood vessel according to the position and size of the second artificial blood vessel.

9. The artificial blood vessel kit as described in claim 1 or 2, characterized in that: The retaining ring is elastically deformable, so that the outer edge in contact with the periphery of the hole expands or deforms.

10. An artificial blood vessel, characterized in that: The artificial blood vessel is tubular and capable of being sutured to other tubular bodies at least at one end. An annular retaining ring is installed in the hole provided in the pipe wall to reinforce the periphery of the hole. The fixation ring itself contains X-ray non-transmissive elements and has a through hole on one side near the end of the artificial blood vessel for the suture needle to pass through.

11. The artificial blood vessel as described in claim 10, characterized in that: The retaining ring has a body component disposed on one side of the inner and outer surfaces of the pipe wall, and a washer component disposed on the other side. The body component has a cylindrical portion that passes through the hole and a flange portion that continues to one end of the cylindrical portion. After the cylindrical portion of the body component passes through the through hole provided in the washer component, it is plastically deformed and pressed against the washer component, thereby installing the retaining ring in the hole.

12. The artificial blood vessel as described in claim 11, characterized in that: A gasket is inserted between the pipe wall and the body component and the gasket component.

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