Aneurysmal treatment system and method

Abstract

To provide a system and a method capable of treating an aneurysm even when the aneurysm is relatively small.SOLUTION: A system 10 has an implant body 20 and a joint part 30. The implant body includes a ring-shaped skeleton part 50 having a self-expanding force, and can expand or contract in a radial direction. In the joint part, the implant body in an expanded state of being deployed in an aneurysm 100 is joined to an aneurysm wall 101. The skeleton part includes: a ring-shaped body part 51; and an anchor part 52 extending from the body part to the radially outside and inserted to the aneurysm wall. The anchor part functions as the joint part.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] The present invention relates to aneurysm treatment systems and methods. [Background technology]

[0002] There is no medical treatment for aneurysms that develop in a patient's aorta (aortic aneurysms) to prevent the aneurysm from growing larger or rupturing, and for aneurysms large enough to rupture, surgical treatment is generally performed. Traditionally, surgery for aortic aneurysms has mainly involved artificial vascular replacement, in which an artificial blood vessel is implanted via abdominal or thoracotomy, but in recent years, the use of the less invasive stent graft repair (Endovascular Aneurysm Repair; EVAR) has been rapidly expanding.

[0003] As an example, in stent graft insertion surgery for abdominal aortic aneurysms (AAA), a catheter with a stent graft at its tip is inserted through the patient's femoral artery, and the stent graft is deployed and placed at the site of the aneurysm, thereby blocking blood flow to the aneurysm and preventing the aneurysm from rupturing.

[0004] Generally, stent grafts used in endovascular stent graft insertion have a structure that can be assembled from two types of components: a "main body" with a branching portion that branches into a roughly Y-shape, and "leg portions" that are attached to the branching portion and are attached to the right iliac artery and the left iliac artery, respectively (see Patent Document 1). One end of the main body is anchored to an upper healthy portion (landing zone). The upper healthy portion is located below the connection point of the renal arteries and above the site of abdominal aortic aneurysm. The main body is deployed so as to pass through the abdominal aortic aneurysm. The end of the leg portion attached to the branching portion of the main body is anchored to a lower healthy portion. The lower healthy portion is located in the common iliac artery (or abdominal aorta) that connects to the downstream side of the abdominal aorta. In this way, the stent graft is placed in the aorta. [Prior art documents] [Patent documents]

[0005] [Patent Document 1] Patent No. 4052397 Summary of the Invention [Problem to be solved by the invention]

[0006] Aortic aneurysms are diagnosed by CT scan. Even if an aortic aneurysm is diagnosed, if the aneurysm is small, EVAR may not be an option. In such cases, regular follow-up is performed (see the 2020 revised edition of the Guidelines for the Management of Aortic Aneurysms and Aortic Dissections, Diagnosis and Treatment Cascade for Abdominal Aortic Aneurysms (Figure 47)).

[0007] However, even for small aneurysms that are not candidates for EVAR, there is a risk of rupture, and patients are often monitored with anxiety. For this reason, there is a need for a method to physically restrain the expansion of aneurysms, even when the aneurysm is relatively small.

[0008] An object of the present invention is to provide an aneurysm treatment system and method that can physically suppress the expansion of an aneurysm. [Means for solving the problem]

[0009] The present invention provides: (1) an implant body including a ring-shaped framework having a self-expanding force and capable of expanding and contracting in a radial direction; and a joint portion that joins the implant body in an expanded state deployed within the aneurysm to the aneurysm wall.

[0010] Here, an embodiment of the present invention is (2) In the aneurysm repair system described in (1) above, the framework comprises a ring-shaped main body and anchors extending radially outward from the main body and inserted into the aneurysm wall; It is preferable that the anchor portion functions as the joining portion.

[0011] (3) In the aneurysm repair system described in (2) above, the framework has a zigzag structure that extends in the circumferential direction of the implant body while forming a plurality of vertices, The anchor portion is preferably formed at at least one of the plurality of vertices and between two adjacent vertices of the plurality of vertices along the zigzag structure.

[0012] (4) In the aneurysm treatment system described in (2) or (3) above, it is preferable that the anchor portion has a needle structure including a barb at the tip portion arranged radially outward.

[0013] (5) In the aneurysm repair system described in (1) above, it is preferable that the implant body has a tubular base material and the framework portion that is assembled to the base material and maintains the shape of the base material.

[0014] (6) The aneurysm treatment system described in (5) above preferably has a surface layer on the outer peripheral surface of the substrate that promotes cell infiltration into the substrate.

[0015] (7) The aneurysm repair system according to (5) above, wherein the framework has anchors disposed radially outward from the outer circumferential surface of the base material and inserted into the aneurysm wall, It is preferable that the anchor portion functions as the joining portion.

[0016] (8) In the aneurysm treatment system described in (7) above, it is preferable that the anchor portion is arranged on the outer peripheral surface of any of a first end portion in the axial direction of the base material, a second end portion opposite the first end portion, and a central portion between the first end portion and the second end portion.

[0017] (9) In the aneurysm repair system described in (5) above, the joint portion is provided as a separate body from the implant body, and is an anchor that penetrates the base material of the implant body from the inside of the base material and is driven into the aneurysm wall, The aneurysm repair system preferably further includes a delivery catheter for delivering the anchor inside the base material of the implant body placed in the aneurysm.

[0018] (10) In the aneurysm repair system described in (5) above, the bonding portion is an adhesive applied to the outer peripheral surface of the implant body, It is preferable that the aneurysm repair system further includes a delivery catheter that is inserted between the outer peripheral surface of the base material of the implant body placed in the aneurysm and the aneurysm wall, and is capable of applying the adhesive.

[0019] (11) In the aneurysm treatment system described in (2) or (7) above, it is preferable that the skeletal portion is expandable to an over-expanded state in which the skeletal portion is expanded radially further than the expanded state due to the self-expansion force, and has a restoring force that attempts to return from the over-expanded state to the expanded state.

[0020] The present invention provides a method for treating aneurysms by deploying an expandable implant body, which includes a ring-shaped framework having a self-expanding force, within the aneurysm; the implant body in an expanded state deployed within the aneurysm is joined to the aneurysm wall using a joining portion; The method treats the aneurysm with the framework of the implant body joined to the aneurysm wall.

[0021] Here, an embodiment of the present invention is (13) The method according to (12) above includes the steps of: preparing the implant body, the skeleton portion of which has a ring-shaped main body portion and an anchor portion that extends radially outward from the main body portion and functions as the joint portion; It is preferable that the implant body be deployed within the aneurysm, so that the anchor portion penetrates the aneurysm wall and the implant body is joined to the aneurysm wall.

[0022] (14) The method according to (12) above includes the steps of: preparing the implant body having a cylindrical base material and the skeleton portion assembled to the base material to maintain the shape of the base material; It is preferable that the implant body deployed within the aneurysm be bonded to the aneurysm wall, thereby maintaining the outer surface of the base material in contact with or close proximity to the aneurysm wall, thereby suppressing blood flow between the aneurysm wall and the outer surface of the base material.

[0023] (15) The method according to (14) above, further comprising the steps of: preparing the implant body, wherein the skeleton portion has an anchor portion that functions as the joint portion and is disposed radially outward from an outer circumferential surface of the base material; It is preferable that the implant body be deployed within the aneurysm, so that the anchor portion penetrates the aneurysm wall and the implant body is joined to the aneurysm wall.

[0024] (16) The method according to (14) above further comprises preparing an anchor as the joint portion, which is provided separately from the implant body, and which penetrates the base material of the implant body from the inside thereof and is driven into the aneurysm wall; The anchor is preferably delivered by a delivery catheter to the inside of the substrate of the implant body placed within the aneurysm.

[0025] (17) The method according to (14) above further comprises preparing an adhesive to be applied to the outer peripheral surface of the implant body as the joining portion; It is preferable that the adhesive be applied between the outer peripheral surface of the base material of the implant body placed in the aneurysm and the aneurysm wall by a delivery catheter.

[0026] (18) The method according to (13) or (15) above further comprises preparing the implant body, the framework of which has an outer diameter equal to or smaller than the diameter of the aneurysm in a natural state; the implant body deployed within the aneurysm is expanded using an expandable expander to a diameter greater than the outer diameter of the framework portion in its natural state, whereby the anchor portion is pierced into the aneurysm wall and the implant body is joined to the aneurysm wall; It is preferable that the diameter of the aneurysm be reduced by the force that causes the framework to return to its natural outer diameter.

[0027] (19) In the method described in (12) above, it is preferable that the implant body is deployed within the aneurysm so that the implant body is joined to the aneurysm wall at the maximum aneurysm diameter portion by the joint portion.

[0028] (20) In the method according to any one of (14) to (17) above, it is preferable that the implant body is deployed within the aneurysm so that the base material blocks a side branch blood vessel extending from the aneurysm.

[0029] (21) The aneurysm repair system described in (11) above further comprises a delivery catheter having an expandable and contractible expansion body at a distal end thereof and having fixing means for fixing the implant body on the contracted expansion body; It is preferable that the expandable body has a maximum expanded diameter that is larger than the expanded diameter of the skeletal portion in the expanded state.

[0030] (22) In the aneurysm repair system described in (1) above, it is preferable that a compound that reinforces vascular tissue is carried in the portion of the implant body that comes into contact with the aneurysm wall so as to be releasable toward the aneurysm wall.

[0031] (23) The method according to (12) above further comprises carrying a compound that reinforces vascular tissue on a portion of the implant body that comes into contact with the aneurysm wall, Preferably, the compound is released towards the aneurysm wall from the portion of the implant body that is joined to the aneurysm wall. [Brief explanation of the drawings]

[0032] [Figure 1]FIG. 1 is a diagram schematically showing an example of use of the aneurysm treatment system according to the first embodiment. [Figure 2] FIG. 1 is a side view showing an implant body according to a first embodiment. [Figure 3] 1 is a cross-sectional view showing how an aneurysm is treated by the aneurysm treatment system. [Figure 4A] FIG. 10 is a cross-sectional view showing an example of the tip of an anchor part having a needle structure. [Figure 4B] FIG. 10 is a cross-sectional view showing another example of the tip of the anchor part having a needle structure. [Figure 4C] FIG. 10 is a cross-sectional view showing yet another example of the tip of the anchor part having a needle structure. [Figure 5A] 10A to 10C are views schematically showing a procedure for placing an implant body according to Modification 1 of the first embodiment inside an aneurysm. [Figure 5B] FIG. 5B is a diagram following FIG. 5A and schematically showing the procedure for placing the implant body in the aneurysm. [Figure 5C] FIG. 5C is a diagram following FIG. 5B that schematically illustrates the procedure for placing the implant body in the aneurysm. [Figure 6] FIG. 10 is a diagram schematically showing an example of use of the aneurysm treatment system according to Modification 2 of the first embodiment. [Figure 7] FIG. 10 is a side view showing an implant body according to Modification 2 of the first embodiment. [Figure 8] 1 is a cross-sectional view showing how an aneurysm is treated by the aneurysm treatment system. [Figure 9] FIG. 10 is a diagram schematically showing an example of use of an aneurysm treatment system according to a third modification of the first embodiment. [Figure 10] 1 is a cross-sectional view showing how an aneurysm is treated by the aneurysm treatment system. [Figure 11] FIG. 10 is a side view showing an implant body according to a fourth modification of the first embodiment. [Figure 12] 1 is a cross-sectional view showing how an aneurysm is treated by the aneurysm treatment system. [Figure 13] FIG. 11 is a side view showing an implant body according to a fifth modification of the first embodiment. [Figure 14] 1 is a cross-sectional view showing how an aneurysm is treated by the aneurysm treatment system. [Figure 15] FIG. 10 is a diagram schematically illustrating an example of use of the aneurysm treatment system according to the second embodiment. [Figure 16] FIG. 10 is a side view showing an implant body according to a second embodiment. [Figure 17] 1 is a cross-sectional view showing how an aneurysm is treated by the aneurysm treatment system. [Figure 18A] 10A to 10C are views schematically showing a procedure for placing an implant body according to a modified example of the second embodiment inside an aneurysm. [Figure 18B] FIG. 18B is a diagram following FIG. 18A and schematically showing the procedure for placing the implant body in the aneurysm. [Figure 18C] FIG. 18C is a diagram following FIG. 18B that schematically illustrates the procedure for placing the implant body in the aneurysm. DETAILED DESCRIPTION OF THE INVENTION

[0033] Hereinafter, embodiments of the present invention will be described in detail with reference to the drawings. The embodiments shown here are merely examples for embodying the technical concept of the present invention and are not intended to limit the present invention. Therefore, all other embodiments, examples, and operational techniques that can be conceived by those skilled in the art without departing from the spirit of the present invention are included within the scope and spirit of the present invention, as well as within the scope of the claims and their equivalents.

[0034] In addition, for the convenience of illustration and ease of understanding, the drawings attached to this specification may be represented schematically with the scale, aspect ratio, shape, etc. appropriately changed from the actual product, but these are merely examples and do not limit the interpretation of the present invention.

[0035] In this specification, ordinal numbers such as "first" and "second" may be used. However, unless otherwise specified, these ordinal numbers are used to identify components for the convenience of explanation and do not specify the number or order. Furthermore, "end" refers to a region that includes a certain range from the end in the axial direction.

[0036] First Embodiment (Aneurysm Treatment System) Fig. 1 is a schematic diagram showing an example of use of an aneurysm repair system 10 according to the first embodiment, Fig. 2 is a side view showing an implant main body 20 according to the first embodiment, and Fig. 3 is a cross-sectional view showing how an aneurysm 100 is treated by the aneurysm repair system 10. Figs. 4A, 4B, and 4C are cross-sectional views showing the tip of an anchor portion 52 having a needle structure.

[0037] As shown in Figures 1, 2, and 3, an aneurysm treatment system 10 according to the first embodiment (hereinafter sometimes simply referred to as "system 10") includes an implant body 20 and a joint portion 30. The system 10 also includes a delivery device 40 (delivery catheter). The implant body 20 and the joint portion 30 are stored in a sheath of the delivery device 40 while folded into a predetermined shape. The implant body 20 and the joint portion 30 are delivered into an aneurysm 100 by the delivery device 40. The implant body 20 is deployed and expanded to be placed in the aneurysm 100 (see Figure 1).

[0038] The implant body 20 includes a ring-shaped framework 50 having a self-expanding force. The implant body 20 is radially expandable and contractible. The joint 30 joins the expanded implant body 20 deployed within the aneurysm 100 to the aneurysm wall 101.

[0039] 1 shows a state in which one implant body 20 is bonded to the aneurysm wall 101. However, this is not limited to this case, and multiple implant bodies 20 can be bonded to the aneurysm wall 101 of one aneurysm 100 by shifting their positions in the axial direction.

[0040] The skeleton 50 includes a ring-shaped main body 51 and anchor portions 52 that extend radially outward from the main body 51 and are inserted into the aneurysm wall 101. The anchor portions 52 function as the joining portions 30. The anchor portions 52 are inserted into the aneurysm wall 101.

[0041] The main body portion 51 is configured to be capable of expanding and contracting in diameter. The main body portion 51 is formed to be self-expandable. The main body portion 51 maintains the expanded state of the implant body 20 by expanding and deforming in the aneurysm 100. The anchor portions 52 are anchored to the aneurysm wall 101. The shape, number, and length of the anchor portions 52, as well as the angle and direction at which the anchor portions 52 extend from the main body portion 51, can be changed as appropriate. The main body portion 51 and the anchor portions 52 are formed from a nickel-titanium alloy, stainless steel, or the like.

[0042] The number of ring-shaped main bodies 51 is not particularly limited. The illustrated skeleton 50 has multiple (three) main bodies 51. The multiple main bodies 51 are arranged at intervals along the axial direction (the direction in which the blood vessels extend). The main bodies 51 may be independent of each other or may be connected to each other. In the illustrated example, the main bodies 51 are independent of each other, but are attached to a substrate, which will be described later.

[0043] The term "ring-shaped" in relation to the shape of the main body 51 includes not only a closed circular shape, but also a helical shape in which the radius remains constant and extends in the axial direction, and a spiral shape in which the radius changes and extends in the axial direction. Therefore, in the case of a main body 51 having a helical or spiral shape, although there is only one main body 51, the shape is as if multiple main bodies 51 were arranged along the axial direction.

[0044] The term "radially outward" with respect to the direction in which the anchor portions 52 extend from the main body portion 51 does not limit a specific angle or direction, but includes any angle or direction as long as there is a possibility that the anchor portions 52 can be inserted into the aneurysm wall 101. In the illustrated example, all of the anchor portions 52 extend radially outward from the main body portion 51 and downward on the page (see FIG. 2). The anchor portions 52 may extend left or right or upward on the page. Anchor portions 52 extending from the main body portion 51 at different angles or directions may be mixed.

[0045] 2, the skeleton portion 50 has a zigzag structure that forms a plurality of vertices 50a and extends in the circumferential direction of the implant body 20. The anchor portions 52 are formed at at least one of the plurality of vertices 50a and between two adjacent vertices 50a along the zigzag structure among the plurality of vertices 50a.

[0046] The shape of the main body 51 of the skeleton 50 is not limited to the above-described shape and can be modified to any appropriate shape as long as it allows the implant body 20 to be appropriately deployed. The position of the main body 51 where the anchor portion 52 is formed is also not limited to the above-described position.

[0047] As shown in Fig. 4A, the anchor portion 52 has a needle structure including a barb 53 at its tip located radially outward. The anchor portion 52 is not limited to the needle structure shown in Fig. 4A and can be modified to have an appropriate structure. For example, the anchor portion 52 may have a needle structure as shown in Fig. 4B and Fig. 4C.

[0048] The portion of barbs 53 facing radially inward (portion indicated by reference symbol 53a) may be sharp (see FIG. 4A) or blunt (see FIGS. 4B and 4C). When the portion facing radially inward is blunt, the aneurysm wall 101 is less likely to tear even when anchor portion 52 inserted into the aneurysm wall 101 is pulled, compared to when the portion is sharp.

[0049] The implant body 20 has a cylindrical base material 60 and a skeleton portion 50 that is assembled to the base material 60 and maintains the shape of the base material 60.

[0050] The "cylindrical" shape of the substrate 60 is not particularly limited in terms of the shape of the cross section perpendicular to the axial direction of the substrate 60 or the shape of the longitudinal section along the axial direction of the substrate 60. The cross section of the substrate 60 can be any suitable shape, such as a circle, a zigzag circle, an ellipse, a rectangle, or a polygon. The longitudinal section can be any suitable shape, such as a rectangle with a uniform diameter along the axial direction, a trapezoid with different diameters at both ends in the axial direction, or a barrel-like shape with a bulge in the center in the axial direction.

[0051] The main body 51 of the skeleton 50 may be fixed to either the outer circumferential surface or the inner circumferential surface of the base material 60. In the illustrated example, the main body 51 of the skeleton 50 is fixed to the outer circumferential surface of the base material 60.

[0052] The substrate 60 is formed from a porous material such as a fabric woven with threads of a biocompatible resin such as polyester or ePTFE.

[0053] As described above, the skeleton 50 has the anchor portions 52 that are inserted into the aneurysm wall 101, and the anchor portions 52 function as the joining portions 30. In the first embodiment, the anchor portions 52 are disposed radially outward from the outer peripheral surface of the base material 60.

[0054] The length by which the anchor portion 52 protrudes from the outer peripheral surface of the base material 60 can be set appropriately, but one example is about 2 mm.

[0055] In a configuration in which the main body 51 of the skeleton 50 is fixed to the inner circumferential surface of the substrate 60 , the anchor portions 52 penetrate the substrate 60 and are exposed on the outer circumferential surface of the substrate 60 .

[0056] The anchor portion 52 is arranged on the outer peripheral surface of the first end portion 60a in the axial direction of the substrate 60, the second end portion 60b opposite the first end portion 60a, and the central portion 60c between the first end portion 60a and the second end portion 60b (see Figure 2).

[0057] (method) Next, a procedure for placing the implant body 20 of the first embodiment inside the aneurysm 100 will be described.

[0058] The implant body 20 is delivered into the aneurysm 100 by the delivery device 40. The implant body 20 includes a ring-shaped framework portion 50 that has a self-expanding force and is expandable and contractible.

[0059] Once the implant body 20 has been delivered into the aneurysm 100, the implant body 20 is deployed within the aneurysm 100. Next, the expanded implant body 20 deployed within the aneurysm 100 is joined to the aneurysm wall 101 using the joint 30. Then, the aneurysm 100 is treated by the framework 50 of the implant body 20 joined to the aneurysm wall 101.

[0060] According to the system 10 and method of the first embodiment, the implant body 20 deployed within the aneurysm 100 expands due to the self-expansion force of the framework 50 and is bonded to the aneurysm wall 101 by the bonding portion 30. The expanded implant body 20 physically prevents the aneurysm 100 from expanding beyond its natural diameter. In other words, even if the aneurysm 100 attempts to expand, the implant body 20 bonded to the aneurysm wall 101 prevents the aneurysm from expanding, physically preventing the aneurysm from expanding. This makes it possible to treat the aneurysm 100 even if it is relatively small and not a candidate for EVAR (e.g., a maximum minor axis of 30 mm or more, smaller than the size suitable for EVAR). The patient can feel a great sense of relief knowing that treatment has been performed.

[0061] When the aneurysm 100 is relatively large and suitable for EVAR (for example, maximum minor axis is 55 mm or more for men, 50 mm or more for women), the system 10 of the first embodiment may be applied instead of EVAR.

[0062] One of the factors that causes the aneurysm 100 to expand is shear stress acting on the aneurysm 100. When shear stress acts on the aneurysm 100, nitric oxide (NO) is produced by endothelial cells. Nitric oxide (NO) is a compound that acts on the aneurysm 100 by oxidizing oxygen. 2- The strong oxidative effect of oxidizing agents induces remodeling of the extracellular matrix (ECM) and apoptosis of smooth muscle cells, promoting aneurysm expansion. In addition, shear stress increases vascular endothelial growth factor (VEGF) and intercellular adhesion molecule-2 (ICAM-2), creating gaps in endothelial cells and increasing adhesion of inflammatory cells, further promoting aneurysm expansion.

[0063] According to the system 10 of the first embodiment, by covering the aneurysm wall 101 with the implant main body 20, it is possible to reduce the shear stress acting on the aneurysm 100 and reduce factors that cause the aneurysm 100 to expand. Furthermore, by covering the aneurysm wall 101 with the implant main body 20, it is possible to suppress the pressure acting on the weakened aneurysm wall 101.

[0064] If a symptom occurs in which the enlargement of the aneurysm diameter does not stop after the implant body 20 has been joined to the aneurysm wall 101, EVAR can be additionally performed while the implant body 20 is left in place.

[0065] Furthermore, the implant body 20 is implanted in the aneurysm 100 by a procedure similar to that of EVAR. Therefore, it is possible to provide a system 10 that reduces doctors' resistance to the procedure.

[0066] More specifically, in the first embodiment, an implant body 20 having a cylindrical base material 60 and a skeleton portion 50 that is assembled to the base material 60 and maintains the shape of the base material 60 is prepared.

[0067] By bonding the implant body 20 deployed within the aneurysm 100 to the aneurysm wall 101, the outer circumferential surface of the base material 60 is kept in contact with or close to the aneurysm wall 101. This prevents blood from flowing between the aneurysm wall 101 and the outer circumferential surface of the base material 60.

[0068] Here, the prepared implant body 20 has a skeleton portion 50 having anchor portions 52 that function as joining portions 30 and are arranged radially outward from the outer circumferential surface of the base material 60 .

[0069] By deploying the implant body 20 within the aneurysm 100 , the anchor portion 52 penetrates the aneurysm wall 101 and the implant body 20 is joined to the aneurysm wall 101 .

[0070] It is preferable that the implant body 20 is deployed within the aneurysm 100 so that the implant body 20 is joined to the aneurysm wall 101 at the portion of the aneurysm 100 with the maximum aneurysm diameter by the joining portion 30 .

[0071] The aneurysm 100 may expand due to blood flowing in from small blood vessels (side branch vessels 102, see FIG. 1) that branch off from the aneurysm 100.

[0072] In such a case, it is preferable to deploy the implant body 20 within the aneurysm 100 so that the base material 60 blocks the side branch blood vessels 102 extending from the aneurysm 100 .

[0073] The aneurysm 100 may rupture, causing bleeding from the rupture site.

[0074] In such a case, it is preferable to deploy the implant body 20 inside the aneurysm 100 so that the ruptured site is blocked by the base material 60. In this way, the ruptured site can be blocked by the base material 60. Therefore, bleeding at the ruptured site of the aneurysm 100 can be stopped.

[0075] Similarly, the implant body 20 can be deployed within the aneurysm 100 so that the substrate 60 seals the cracked areas at the entrance / exit points of the dissection in the aortic dissection.

[0076] (Action and effect) As described above, the system 10 according to the first embodiment includes the implant body 20, which includes the ring-shaped framework 50 having self-expanding force and is radially expandable and contractible, and the joining portion 30 that joins the expanded implant body 20 deployed within the aneurysm 100 to the aneurysm wall 101. With this configuration, the expanded implant body 20 physically prevents the aneurysm 100 from expanding beyond its own diameter. This makes it possible to treat the aneurysm 100 by physically preventing the aneurysm 100 from expanding, even if the aneurysm 100 is relatively small and not a target for EVAR.

[0077] The skeleton 50 includes a ring-shaped main body 51 and anchor portions 52 that extend radially outward from the main body 51 and are inserted into the aneurysm wall 101, and the anchor portions 52 function as the joining portions 30. With this configuration, the anchor portions 52 can fully perform the function of the joining portions 30, which is to join the expanded implant main body 20 to the aneurysm wall 101.

[0078] The skeleton 50 has a zigzag structure that extends in the circumferential direction of the implant body 20 while forming a plurality of vertices 50a. The anchor portions 52 are formed at at least one of the vertices 50a and between two adjacent vertices 50a of the plurality of vertices 50a along the zigzag structure. With this configuration, the zigzag structure of the skeleton 50 makes it easier for the implant body 20 to expand and contract in the radial direction, increasing the expandable dimensions. By forming the anchor portions 52 at the above positions, they are easily anchored to the aneurysm wall 101.

[0079] Anchor portion 52 has a needle structure including barbs 53 at its tip portion located radially outward. With this configuration, anchor portion 52 is less likely to come out of aneurysm wall 101 after piercing aneurysm wall 101 due to barbs 53.

[0080] The implant body 20 has a cylindrical base material 60 and a skeleton 50 that is assembled to the base material 60 and maintains the shape of the base material 60. With this configuration, the base material 60 of the deployed implant body 20 can be maintained by the skeleton 50 and brought into contact with the aneurysm wall 101.

[0081] The skeleton 50 has anchor portions 52 that are disposed radially outward from the outer peripheral surface of the substrate 60 and that are inserted into the aneurysm wall 101. The anchor portions 52 function as the joining portions 30. With this configuration, the substrate 60 that is in contact with the aneurysm wall 101 can be joined to the aneurysm wall 101 by the anchor portions 52.

[0082] The anchor portions 52 are disposed on the outer peripheral surface of each of the first end portion 60a in the axial direction of the substrate 60, the second end portion 60b opposite the first end portion 60a, and the central portion 60c between the first end portion 60a and the second end portion 60b. With this configuration, the substrate 60 is joined to the aneurysm wall 101 at multiple locations in the axial direction by the anchor portions 52. This prevents the substrate 60 from curling up or sagging.

[0083] In the method of the first embodiment, an expandable implant body 20 including a ring-shaped skeletal portion 50 with self-expansion capability is deployed within an aneurysm 100. The expanded implant body 20 deployed within the aneurysm 100 is then bonded to the aneurysm wall 101 using the bonding portions 30. The aneurysm 100 is then treated with the skeletal portion 50 of the implant body 20 bonded to the aneurysm wall 101. With this configuration, the implant body 20 deployed within the aneurysm 100 expands due to the self-expansion capability of the skeletal portion 50 and is bonded to the aneurysm wall 101 by the bonding portions 30. The expanded implant body 20 physically prevents the aneurysm 100 from expanding beyond its diameter. The implant body 20 can be implanted within the aneurysm 100 using a method similar to EVAR. If the self-expansion capability of the skeletal portion 50 is insufficient, the implant body 20 may be expanded using an expandable expander such as a balloon. This allows the anchor portion 52 to be firmly inserted into the aneurysm wall 101 , and the implant body 20 can be firmly joined to the aneurysm wall 101 .

[0084] An implant body 20 is prepared, which includes a cylindrical substrate 60 and a framework 50 that is attached to the substrate 60 and maintains the shape of the substrate 60. The implant body 20 is deployed within an aneurysm 100 and bonded to the aneurysm wall 101, thereby maintaining the outer circumferential surface of the substrate 60 in contact with or close to the aneurysm wall 101 and suppressing blood flow between the aneurysm wall 101 and the outer circumferential surface of the substrate 60. With this configuration, the implant body 20 covers the aneurysm wall 101, thereby reducing shear stress acting on the aneurysm 100 and reducing factors that cause the aneurysm 100 to expand. Furthermore, covering the aneurysm wall 101 with the implant body 20 suppresses pressure acting on the weakened aneurysm wall 101.

[0085] An implant body 20 is prepared, in which a framework 50 has anchor portions 52 that function as joining portions 30 and are arranged radially outward from the outer circumferential surface of a substrate 60. Next, the implant body 20 is deployed within an aneurysm 100, whereby the anchor portions 52 penetrate the aneurysm wall 101 and the implant body 20 is joined to the aneurysm wall 101. With this configuration, because the anchor portions 52 penetrate the aneurysm wall 101, the expanded implant body 20 can further prevent the aneurysm 100 from expanding beyond the diameter of the implant body 20.

[0086] The implant body 20 is deployed within the aneurysm 100 so that the implant body 20 is joined to the aneurysm wall 101 at the portion of the aneurysm with the largest diameter at the joint 30. With this configuration, the implant body 20 is joined to the aneurysm wall 101 at the portion of the aneurysm with the largest diameter, thereby most effectively preventing the aneurysm from expanding.

[0087] The implant body 20 is deployed within the aneurysm 100 so that the base material 60 blocks the side branch blood vessels 102 extending from the aneurysm 100. With this configuration, the side branches leading to the aneurysm 100 can be embolized with the base material 60. This suppresses the inflow of blood from the side branches, effectively preventing the aneurysm 100 from expanding.

[0088] <Modification 1 of the First Embodiment> Modification 1 of the first embodiment will be described with reference to Figures 5A, 5B, and 5C. Figures 5A, 5B, and 5C are schematic views showing the procedure for placing implant body 20 according to Modification 1 of the first embodiment within aneurysm 100.

[0089] The implant body 20 of Modification 1 differs from the first embodiment in that the main body 51 of the skeleton 50 is self-expandable in that, in addition to being self-expandable, it is formed to be expandable by the balloon 70, which is an expandable and contractible expandable body, to an over-expanded state that exceeds the expanded diameter of the skeleton 50 in its natural state (expanded state due to self-expansion force). The other configurations are the same as those of the first embodiment, so some explanations will be omitted.

[0090] The system 10 of the first modification includes an implant body 20 and a joint portion 30, similar to the first embodiment. The implant body 20 includes a ring-shaped skeletal portion 50 having self-expansion capability. The implant body 20 is radially expandable and contractible. The joint portion 30 joins the expanded implant body 20 deployed within the aneurysm 100 to the aneurysm wall 101. Instead of the delivery device 40 of the first embodiment, the system 10 of the first modification includes a delivery catheter (not shown) in which the implant body 20 is mounted on a balloon 70 serving as an expandable body, with the implant body 20 held down by a sheath. The delivery catheter includes an expandable balloon 70 (corresponding to the expandable body) at its tip. The sheath functions as a fixing means for fixing the implant body 20 on the deflated balloon 70 (corresponding to the expandable body). The maximum expanded diameter of the balloon 70 serving as an expandable body is larger than the expanded diameter of the skeletal portion 50 in its expanded state, allowing the skeletal portion 50 to be further expanded in its natural state.

[0091] The skeleton portion 50 includes a main body portion 51 and anchor portions 52. The anchor portions 52 are disposed radially outward from the outer peripheral surface of the base material 60 and function as the joining portions 30.

[0092] As shown in Figures 5A, 5B, and 5C, the skeleton 50 of Variation 1 can be expanded to an over-expanded state, which is expanded radially further than the state expanded by its own expansion force (Figures 5A and 5B), and has a restoring force that attempts to return from the over-expanded state to the expanded state (Figure 5C). The size of the base material 60 is somewhat large enough to allow the skeleton 50 to be over-expanded. Therefore, when the implant body 20 is deployed within the aneurysm 100, wrinkles occur in the base material 60. The outer diameter of the base material 60 is approximately equal to the inner diameter of the ring-shaped main body 51 when the main body 51 is expanded.

[0093] (method) Next, a procedure for placing the implant body 20 of Modification 1 inside the aneurysm 100 will be described. Explanation of the procedures common to the first embodiment will be omitted.

[0094] An implant body 20 is prepared. Here, in the prepared implant body 20, a skeletal portion 50 has anchor portions 52 that function as joining portions 30 arranged radially outward from the outer circumferential surface of a substrate 60. Furthermore, in the prepared implant body 20, the skeletal portion 50 has an outer diameter that is equal to or smaller than the diameter of the aneurysm 100 in its natural state.

[0095] Once the implant body 20 has been delivered into the aneurysm 100, the implant body 20 is deployed within the aneurysm 100 (see FIG. 5A). Next, the implant body 20 deployed within the aneurysm 100 is expanded (overexpanded) using a balloon 70, which is an expandable and contractible expander, to a diameter greater than the outer diameter of the framework portion 50 in its natural state. By temporarily overexpanding the implant body 20, the anchor portion 52 is pierced into the aneurysm wall 101, and the implant body 20 is joined to the aneurysm wall 101 (see FIG. 5B).

[0096] Thereafter, the expansion of the balloon 70, which is an expandable and contractible expansion body, is released, thereby releasing the temporary overexpansion of the implant body 20. The force of the skeleton 50 returning to its natural outer diameter causes the diameter of the base material 60 to decrease, and the diameter of the aneurysm 100 also decreases (see FIG. 5C).

[0097] In this way, the implant body 20 can suppress the expansion force on the aneurysm wall 101, and rather provide a force that reduces the diameter of the aneurysm 100.

[0098] (Action and effect) As described above, in the system 10 according to the first modification of the first embodiment, the framework 50 can be expanded to an overexpanded state, which is expanded radially further than the state expanded by the self-expansion force, and has a restoring force that attempts to return from the overexpanded state to the expanded state. With this configuration, the diameter of the aneurysm 100 can be reduced by the force that returns the framework 50 to its natural outer diameter.

[0099] In the method of Variation 1 of the first embodiment, an implant body 20 is prepared, in which the skeletal portion 50 has an outer diameter equal to or smaller than the diameter of the aneurysm 100 in its natural state. Next, the implant body 20 deployed within the aneurysm 100 is expanded using a balloon 70, which is an expandable and contractible expander, to a diameter greater than the outer diameter of the skeletal portion 50 in its natural state, thereby causing the anchor portions 52 to penetrate the aneurysm wall 101 and bonding the implant body 20 to the aneurysm wall 101. The force of the skeletal portion 50 returning to its natural outer diameter then reduces the diameter of the aneurysm 100. With this configuration, the force of the skeletal portion 50 returning to its natural outer diameter can be transmitted to the aneurysm wall 101 via the anchor portions 52, effectively reducing the diameter of the aneurysm 100.

[0100] <Modification 2 of the First Embodiment> Modification 2 of the first embodiment will be described with reference to Figures 6, 7, and 8. Figure 6 is a diagram schematically illustrating an example of use of system 10 according to Modification 2 of the first embodiment, Figure 7 is a side view showing implant body 20 according to Modification 2 of the first embodiment, and Figure 8 is a cross-sectional view showing how an aneurysm 100 is treated using system 10.

[0101] The system 10 of the second modification differs from the first embodiment in that the joint 30 is composed of an anchor 54 provided separately from the implant body 20, in that the anchor 52 functioning as the joint 30 is integrated with the implant body 20. The other configurations are the same as those of the first embodiment, and therefore some explanations will be omitted.

[0102] The system 10 of the second modification includes an implant body 20 and a joint portion 30, similar to the first embodiment. The implant body 20 includes a ring-shaped framework portion 50 that has a self-expanding force. The implant body 20 is radially expandable and contractible. The joint portion 30 joins the expanded implant body 20 deployed within the aneurysm 100 to the aneurysm wall 101.

[0103] The implant body 20 has a cylindrical base material 60 and a skeleton part 50 that is assembled to the base material 60 and maintains the shape of the base material 60. In the illustrated example, a main body part 51 of the skeleton part 50 is fixed to the outer peripheral surface of the base material 60.

[0104] 6, 7, and 8, the joint portion 30 of the second modification is provided as a separate body from the implant body 20, and is composed of an anchor 54 that penetrates the base material 60 of the implant body 20 from inside the base material 60 and is driven into the aneurysm wall 101. The system 10 further includes a delivery catheter 41 for delivering the anchor 54 to the inside of the base material 60 of the implant body 20 that is disposed within the aneurysm 100.

[0105] In this specification, the "anchor 54" can take various forms as long as it can penetrate the substrate 60 and be driven into the aneurysm wall 101 to fix the substrate 60 to the aneurysm wall 101. The anchor 54 may or may not penetrate the aneurysm wall 101. Examples of the anchor 54 include a screw-shaped needle that can penetrate the aneurysm wall 101, a staple needle whose tip is bent after penetrating the aneurysm wall 101, a suture, a hook, a clip, a tack, and the like. The anchor 54 shown in the figure is a screw-shaped needle.

[0106] The delivery catheter 41 delivers anchors 54 of various forms to the inside of the substrate 60. The delivery catheter 41 penetrates the substrate 60 from the inside and drives the anchors 54 into the aneurysm wall 101. The anchors 54 are sutures that suture the substrate 60 to the aneurysm wall 101 using a device similar to that used to suture blood vessels or menisci.

[0107] (method) Next, a procedure for placing the implant body 20 of Modification 2 inside the aneurysm 100 will be described. Explanation of the procedures common to the first embodiment will be omitted.

[0108] An anchor 54 is prepared as the joint 30. The anchor 54 is provided as a separate body from the implant body 20, and is driven into the aneurysm wall 101 from the inside of the base material 60 of the implant body 20, penetrating the base material 60.

[0109] Once the implant body 20 has been delivered to the inside of the aneurysm 100, the implant body 20 is deployed within the aneurysm 100. The implant body 20 is positioned within the aneurysm 100.

[0110] The delivery catheter 41 delivers the anchor 54 to the inside of the base material 60 of the implant body 20 placed in the aneurysm 100 (see FIG. 6). The delivery catheter 41 penetrates the base material 60 from the inside and drives the anchor 54 into the aneurysm wall 101.

[0111] As a result, the implant body 20 deployed within the aneurysm 100 is joined to the aneurysm wall 101 by driving in the anchors 54 (see FIG. 8).

[0112] (Action and effect) As described above, in the system 10 according to the second modification of the first embodiment, the joining portion 30 is formed from the anchor 54, which is provided separately from the implant main body 20 and is driven into the aneurysm wall 101 from the inside of the base material 60 of the implant main body 20, penetrating the base material 60. The system 10 further includes a delivery catheter 41 for delivering the anchor 54 to the inside of the base material 60 of the implant main body 20 placed in the aneurysm 100. With this configuration, the base material 60 in contact with the aneurysm wall 101 can be joined to the aneurysm wall 101 by the anchor 54, which is provided separately from the implant main body 20.

[0113] In the method of the second modification of the first embodiment, an anchor 54 is prepared as the joining portion 30, which is provided separately from the implant main body 20 and is driven into the aneurysm wall 101 from the inside of the base material 60 of the implant main body 20, penetrating the base material 60. Next, the anchor 54 is delivered by a delivery catheter 41 to the inside of the base material 60 of the implant main body 20 placed in the aneurysm 100. With this configuration, the anchor 54, which is provided separately from the implant main body 20, can be delivered by the delivery catheter 41 to the inside of the base material 60, and the base material 60 in contact with the aneurysm wall 101 can be joined to the aneurysm wall 101.

[0114] <Modification 3 of the First Embodiment> Modification 3 of the first embodiment will be described with reference to Figures 9 and 10. Figure 9 is a diagram schematically illustrating an example of use of system 10 according to Modification 3 of the first embodiment, and Figure 10 is a cross-sectional view illustrating the treatment of an aneurysm 100 using system 10.

[0115] The system 10 of the third modification differs from the first embodiment in which the anchor portion 52 functions as the joining portion 30 in that the joining portion 30 is composed of an adhesive 80 applied to the outer peripheral surface of the implant body 20. The other configurations are the same as those of the first embodiment, and therefore some explanations will be omitted.

[0116] The system 10 of the third modification includes an implant body 20 and a joint portion 30, similar to the first embodiment. The implant body 20 includes a ring-shaped framework portion 50 that has a self-expanding force. The implant body 20 is radially expandable and contractible. The joint portion 30 joins the expanded implant body 20 deployed within the aneurysm 100 to the aneurysm wall 101.

[0117] The implant body 20 has a cylindrical base material 60 and a skeleton portion 50 that is assembled to the base material 60 and maintains the shape of the base material 60.

[0118] 9 and 10 , the joint 30 of Modification 3 is composed of an adhesive 80 applied to the outer peripheral surface of the implant main body 20. The system 10 further includes a delivery catheter 42 that is inserted between the outer peripheral surface of the base material 60 of the implant main body 20 placed in the aneurysm 100 and the aneurysm wall 101 and that can apply the adhesive 80.

[0119] A cyanoacrylate adhesive 80, which has a short curing time, can be used as the adhesive 80. The delivery catheter 42 applies the adhesive 80 between the outer peripheral surface of the base material 60 and the aneurysm wall 101.

[0120] (method) Next, a procedure for placing the implant body 20 of Modification 3 inside the aneurysm 100 will be described. Explanation of the procedures common to the first embodiment will be omitted.

[0121] As the bonding portion 30, an adhesive 80 to be applied to the outer peripheral surface of the implant body 20 is prepared.

[0122] After the implant body 20 has been delivered to a predetermined position within the aneurysm 100, and before the implant body 20 is deployed, the tip of the adhesive delivery catheter 42 is positioned between the base material 60 of the implant body 20 and the aneurysm wall 101. Thereafter, the implant body 20 is deployed within the aneurysm 100, and the tip of the delivery catheter 41 is inserted between the outer peripheral surface of the base material 60 of the implant body 20 and the aneurysm wall 101 (see FIG. 9 ).

[0123] The delivery catheter 41 is used to apply adhesive 80 between the outer surface of the base material 60 of the implant main body 20 placed within the aneurysm 100 and the aneurysm wall 101. The delivery catheter 41 is pulled out while releasing the adhesive 80. When the tip of the delivery catheter 41 is removed from between the base material 60 and the aneurysm wall 101, application of the adhesive 80 is stopped.

[0124] As a result, the implant body 20 deployed within the aneurysm 100 is bonded to the aneurysm wall 101 by the adhesive 80 (see FIG. 10).

[0125] (Action and effect) As described above, in the system 10 according to the third modification of the first embodiment, the bonding portion 30 is formed from the adhesive 80 applied to the outer peripheral surface of the implant main body 20. The system 10 further includes a delivery catheter 42 that is inserted between the outer peripheral surface of the base material 60 of the implant main body 20 placed in the aneurysm 100 and the aneurysm wall 101, and that is capable of applying the adhesive 80. With this configuration, the base material 60 in contact with the aneurysm wall 101 can be bonded to the aneurysm wall 101 by the adhesive 80.

[0126] In the method of the third modification of the first embodiment, adhesive 80 to be applied to the outer peripheral surface of implant main body 20 is prepared as bonding portion 30. Next, adhesive 80 is applied by delivery catheter 42 between the outer peripheral surface of base material 60 of implant main body 20 placed in aneurysm 100 and aneurysm wall 101. With this configuration, adhesive 80 can be inserted between the outer peripheral surface of base material 60 and aneurysm wall 101 by delivery catheter 41, and the base material 60 in contact with aneurysm wall 101 can be bonded to aneurysm wall 101.

[0127] <Fourth Modification of the First Embodiment> A fourth modification of the first embodiment will be described with reference to Figures 11 and 12. Figure 11 is a side view showing an implant body 20 according to the fourth modification of the first embodiment, and Figure 12 is a cross-sectional view showing how an aneurysm 100 is treated by the system 10.

[0128] The system 10 of the fourth modification example differs from the first embodiment in that it further has a surface layer 91 on the outer peripheral surface of the substrate 60, which promotes cell infiltration into the substrate 60. The other configurations are the same as those of the first embodiment, and therefore description thereof will be omitted.

[0129] The surface layer 91 is formed by making the outer peripheral surface of the base material 60 porous. The surface layer 91 has a lattice structure for cell infiltration and functions as a support structure for incorporating tissue.

[0130] When the implant body 20 is deployed inside the aneurysm 100, the implant body 20 is bonded to the aneurysm wall 101 at the bonding portion 30. Furthermore, cells infiltrate into the base material 60 through the surface layer 91, thereby integrating the base material 60 with the tissue of the aneurysm wall 101. Therefore, the implant body 20 is bonded to the aneurysm wall 101 even more firmly.

[0131] The surface layer 91 may be formed separately from the base material 60. The surface layer 91 may be made of a sheet material having a lattice structure for cell infiltration. The sheet material may be made of a porous material such as a fabric woven with threads of a resin such as polyester, or an open-cell polyurethane foam material. The sheet material is laminated on the outer peripheral surface of the implant body 20.

[0132] <Fifth Modification of the First Embodiment> A fifth modification of the first embodiment will be described with reference to Figures 13 and 14. Figure 13 is a side view showing an implant body 20 according to the fifth modification of the first embodiment, and Figure 14 is a cross-sectional view showing how an aneurysm 100 is treated by the system 10.

[0133] The system 10 of the fifth modified example differs from the first embodiment in that the implant body 20 further includes an adhesive layer 92 that holds an adhesive. The other configurations are the same as those of the first embodiment, and therefore description thereof will be omitted.

[0134] The adhesive layer 92 is formed by impregnating an adhesive into the sponge-like main body 51. The adhesive layer 92 is laminated on the outer peripheral surface of the implant main body 20.

[0135] When the implant body 20 is deployed within the aneurysm 100, the implant body 20 is bonded to the aneurysm wall 101 by the bonding portion 30. Furthermore, adhesive seeps out from the adhesive layer 92 and adheres to the aneurysm wall 101. Therefore, the implant body 20 is bonded to the aneurysm wall 101 even more firmly.

[0136] Second Embodiment The second embodiment will be described with reference to Figures 15, 16, and 17. Figure 15 is a diagram schematically illustrating an example of use of the system 10 according to the second embodiment, Figure 16 is a side view illustrating the implant main body 20 according to the second embodiment, and Figure 17 is a cross-sectional view illustrating the treatment of an aneurysm 100 using the system 10.

[0137] The system 10 of the second embodiment differs from the first embodiment in that the implant body 20 does not have a cylindrical base material 60. The other configurations are the same as those of the first embodiment, and therefore some explanations will be omitted.

[0138] As shown in FIGS. 15, 16, and 17, the system 10 according to the second embodiment also includes an implant body 20 and a joint portion 30, similar to the first embodiment.

[0139] The implant body 20 includes a ring-shaped framework 50 having a self-expanding force. The implant body 20 is radially expandable and contractible. The joint 30 joins the expanded implant body 20 deployed within the aneurysm 100 to the aneurysm wall 101.

[0140] The skeleton 50 includes a ring-shaped main body 51 and anchors 52 that extend radially outward from the main body 51 and are inserted into the aneurysm wall 101. The anchors 52 function as the joining portions 30.

[0141] The skeleton 50 has a plurality of main body portions 51 (three in the illustrated example). Axially adjacent main body portions 51 are connected to each other by connecting wires 51a. The main body portions 51 are configured to be capable of expanding and contracting in diameter. The main body portions 51 are formed to be self-expandable. The main body portions 51 maintain the expanded state of the implant body 20 by expanding and contracting in diameter within the aneurysm 100. The anchor portions 52 anchor to the aneurysm wall 101 within the aneurysm 100. The skeleton 50 may also be configured to have a single main body portion 51. In this case, the connecting wire 51a is omitted.

[0142] (method) Next, a procedure for placing the implant body 20 of the second embodiment inside the aneurysm 100 will be described. Explanation of the procedures common to the first embodiment will be omitted.

[0143] In the second embodiment, an implant body 20 is also prepared. Here, the implant body 20 to be prepared has a skeleton portion 50 having a ring-shaped main body portion 51 and anchor portions 52 that function as joint portions 30 and extend radially outward from the main body portion 51. The implant body 20 does not have a cylindrical base material 60.

[0144] By deploying the implant body 20 within the aneurysm 100 , the anchor portion 52 penetrates the aneurysm wall 101 and the implant body 20 is joined to the aneurysm wall 101 .

[0145] (Action and effect) As described above, in the system 10 according to the second embodiment, the skeleton 50 includes the ring-shaped main body 51 and the anchor portions 52 that extend radially outward from the main body 51 and are inserted into the aneurysm wall 101, and the anchor portions 52 function as the joining portions 30. With this configuration, even if the implant main body 20 does not have a tubular base material 60, the anchor portions 52 can fully function as the joining portions 30 that join the expanded implant main body 20 to the aneurysm wall 101.

[0146] The method of the second embodiment involves preparing an implant body 20, whose framework 50 includes a ring-shaped main body 51 and anchor portions 52 that function as joint portions 30 and extend radially outward from the main body 51. The implant body 20 is then deployed within an aneurysm 100, causing the anchor portions 52 to penetrate the aneurysm wall 101 and bond the implant body 20 to the aneurysm wall 101. With this configuration, even if the implant body 20 does not have a tubular base material 60, the implant body 20 deployed within the aneurysm 100 expands due to the self-expansion force of the framework 50 and is bonded to the aneurysm wall 101 by the joint portions 30. In this way, the expanded implant body 20 physically prevents the aneurysm 100 from expanding beyond its diameter. The implant body 20 can be implanted within the aneurysm 100 using a method similar to EVAR. If the self-expansion force of the framework 50 is insufficient, the implant body 20 may be expanded using an expandable expander such as a balloon. This allows the anchor portion 52 to be firmly inserted into the aneurysm wall 101, firmly joining the implant body 20 to the aneurysm wall 101. Alternatively, the connecting wire 51a that interconnects axially adjacent body portions 51 may be omitted, and multiple implant bodies 20 each having a skeleton portion 50 including one body portion 51 may be implanted in the aneurysm 100 at shifted positions.

[0147] <Modification of the second embodiment> The second embodiment will be described with reference to Figures 18A, 18B, and 18C. Figures 18A, 18B, and 18C are schematic views showing a procedure for placing an implant main body 20 according to the second embodiment inside an aneurysm 100.

[0148] The system 10 of the modified example differs from the first embodiment in that the main body 51 of the skeleton 50 is self-expandable in that the main body 51 of the skeleton 50 is formed to be expandable by a balloon 70, which is an expandable and contractible expandable body, in addition to being self-expandable. Since the other configurations are the same as those of the first embodiment, some explanations will be omitted.

[0149] The system 10 of this modified example has an implant body 20 and a joint portion 30, similar to the second embodiment. The implant body 20 includes a ring-shaped skeleton portion 50 that has a self-expanding force. The implant body 20 is radially expandable and contractible. The joint portion 30 joins the expanded implant body 20 deployed within the aneurysm 100 to the aneurysm wall 101. The skeleton portion 50 includes a main body portion 51 and an anchor portion 52. The anchor portion 52 functions as the joint portion 30.

[0150] As shown in Figures 18A, 18B, and 18C, the skeleton portion 50 of the modified example can be expanded to an over-expanded state in which it is expanded radially further than the expanded state due to its self-expansion force (Figures 18A and 18B), and has a restoring force that attempts to return from the over-expanded state to the expanded state (Figure 18C).

[0151] (method) Next, a procedure for placing the implant body 20 of the modified example inside the aneurysm 100 will be described. Explanation of the procedure common to the second embodiment will be omitted.

[0152] An implant body 20 is prepared. Here, in the prepared implant body 20, a skeleton portion 50 has a ring-shaped main body portion 51 and anchor portions 52 that function as joint portions 30 and extend radially outward from the main body portion 51. Furthermore, in the prepared implant body 20, the skeleton portion 50 has an outer diameter that is equal to or smaller than the diameter of the aneurysm 100 in its natural state. The implant body 20 does not have a tubular base material 60.

[0153] Once the implant body 20 has been delivered into the aneurysm 100, the implant body 20 is deployed within the aneurysm 100 (see FIG. 18A). Next, the implant body 20 deployed within the aneurysm 100 is expanded (overexpanded) using a balloon 70, which is an expandable and contractible expander, to a diameter greater than the outer diameter of the skeletal portion 50 in its natural state. By temporarily overexpanding the implant body 20, the anchor portion 52 is pierced into the aneurysm wall 101, and the implant body 20 is joined to the aneurysm wall 101 (see FIG. 18B).

[0154] Thereafter, the expansion of the balloon 70, which is an expandable and contractible expansion body, is released, thereby releasing the temporary overexpansion of the implant body 20. The force of the skeleton 50 returning to its natural outer diameter causes the diameter of the implant body 20 to decrease, and the diameter of the aneurysm 100 also decreases (see FIG. 18C).

[0155] In this way, the implant body 20 can suppress the expansion force on the aneurysm wall 101, and rather provide a force that reduces the diameter of the aneurysm 100.

[0156] (Action and effect) As described above, in the system 10 according to the modification of the second embodiment, the framework 50 can be expanded to an overexpanded state, which is a state in which the framework 50 is expanded radially further than the state expanded by the self-expansion force, and has a restoring force that attempts to return from the overexpanded state to the expanded state. With this configuration, the diameter of the aneurysm 100 can be reduced by the force that returns the framework 50 to its natural outer diameter.

[0157] In a method according to a modification of the second embodiment, an implant body 20 is prepared, in which the skeletal portion 50 has an outer diameter equal to or smaller than the diameter of the aneurysm 100 in its natural state. The implant body 20 is then deployed within the aneurysm 100 and expanded using a balloon 70, which is an expandable and contractible expander, to a diameter greater than the outer diameter of the skeletal portion 50 in its natural state. This causes the anchor portions 52 to penetrate the aneurysm wall 101, and the implant body 20 to bond to the aneurysm wall 101. The force of the skeletal portion 50 returning to its natural outer diameter reduces the diameter of the aneurysm 100. This configuration allows the force of the skeletal portion 50 returning to its natural outer diameter to be transmitted to the aneurysm wall 101 via the anchor portions 52, effectively reducing the diameter of the aneurysm 100.

[0158] <Other variations> The present invention has been described above through embodiments and modifications, but the present invention is not limited to the described contents and can be modified as appropriate based on the description of the claims.

[0159] For example, a compound that reinforces vascular tissue may be loaded onto the skeletal structure, substrate, or junction (anchor) portion of the implant body that contacts the aneurysm wall, and released toward the aneurysm wall after implantation of the implant body into the aneurysm. Methods for loading the compound include, for example, directly applying the compound to the outer surface of the skeletal structure, substrate, or junction (anchor), making the outer surface of the skeletal structure, substrate, or junction (anchor) porous to allow the compound to adsorb, or forming an adhesive layer on the outer surface of the skeletal structure, substrate, or junction (anchor) to allow the compound to adhere. Examples of such compounds include glutaraldehyde, transglutaminase 2, transforming growth factor-β1, genipin, lysyl oxidase, glucose, and other compounds that crosslink biological substances present in vascular tissue, such as elastin and collagen. Further examples of such compounds include collagen, gelatin, alginic acid, polyethylene glycol, blend polymers of polycaprolactone and polyurethane, catechol derivatives, and naphthalimide derivatives, which improve the physical strength of the aneurysm wall by adhering to the inner surface of the aneurysm wall. [Explanation of symbols]

[0160] 10. Aneurysm Treatment System 20 Implant body 30 Joint 40 Delivery Device 41 Delivery Catheter 42 Delivery Catheter 50 Skeleton 50a apex 51 Main body 51a connecting wire 52 Anchor part 53 Return 54 Anchor 60 Base material 60a First end 60b 2nd end 60c central part 70 Balloon (expandable body) 80 Adhesive 91 Surface layer 92 Adhesive layer 100 Aneurysms 101 Tumor Wall 102 collateral vessels

Claims

1. an implant body including a ring-shaped skeleton portion having a self-expanding force and capable of expanding and contracting in a radial direction; and a joint portion that joins the implant body in an expanded state deployed within the aneurysm to the aneurysm wall.

2. the skeleton portion includes a ring-shaped main body portion and an anchor portion extending radially outward from the main body portion and inserted into the aneurysm wall; The aneurysm repair system according to claim 1 , wherein the anchor portion functions as the joint portion.

3. the skeleton portion has a zigzag structure that extends in the circumferential direction of the implant body while forming a plurality of vertices, The aneurysm treatment system according to claim 2 , wherein the anchor portion is formed at at least one of the plurality of vertices and between two adjacent vertices of the plurality of vertices along the zigzag structure.

4. The aneurysm treatment system according to claim 2 or 3, wherein the anchor portion has a needle structure including a barb at a tip portion disposed radially outward.

5. 2. The aneurysm treatment system according to claim 1, wherein the implant body comprises a tubular base material and the framework portion that is assembled to the base material and maintains the shape of the base material.

6. The aneurysm treatment system according to claim 5 , wherein the outer peripheral surface of the substrate has a surface layer that promotes cell infiltration into the substrate.

7. the skeleton portion has an anchor portion that is disposed radially outward from the outer circumferential surface of the base material and is inserted into the aneurysm wall, The aneurysm repair system according to claim 5 , wherein the anchor portion functions as the joining portion.

8. 8. The aneurysm treatment system according to claim 7, wherein the anchor portion is arranged on the outer peripheral surface of each of a first end portion in the axial direction of the base material, a second end portion opposite the first end portion, and a central portion between the first end portion and the second end portion.

9. the joint portion is an anchor that is provided separately from the implant body and that penetrates the base material of the implant body from the inside of the base material and is driven into the aneurysm wall, The aneurysm repair system according to claim 5 , further comprising a delivery catheter for delivering the anchor inside the base material of the implant body disposed in the aneurysm.

10. the bonding portion is an adhesive applied to the outer peripheral surface of the implant body, 6. The aneurysm repair system according to claim 5, further comprising a delivery catheter that is inserted between the outer peripheral surface of the base material of the implant body placed in the aneurysm and the aneurysm wall, and that is capable of applying the adhesive.

11. 8. The aneurysm treatment system according to claim 2, wherein the framework is expandable to an over-expanded state in which the framework is expanded further in the radial direction than the expanded state due to the self-expansion force, and has a restoring force that attempts to return from the over-expanded state to the expanded state.

12. deploying an expandable implant body within the aneurysm, the expandable implant body including a ring-shaped framework having self-expanding force; the implant body in an expanded state deployed within the aneurysm is joined to the aneurysm wall using a joining portion; The method of treating the aneurysm with the framework of the implant body joined to the aneurysm wall.

13. preparing the implant body, wherein the skeleton portion has a ring-shaped main body portion and an anchor portion that functions as the joint portion and extends radially outward from the main body portion; The method of claim 12, wherein the implant body is deployed within the aneurysm, causing the anchor portion to penetrate the aneurysm wall and joining the implant body to the aneurysm wall.

14. preparing the implant body having a cylindrical base material and the skeleton portion assembled to the base material to maintain the shape of the base material; 13. The method according to claim 12, wherein the outer peripheral surface of the base material is maintained in contact with or in close proximity to the aneurysm wall by bonding the implant body deployed within the aneurysm to the aneurysm wall, thereby suppressing blood flow between the aneurysm wall and the outer peripheral surface of the base material.

15. preparing the implant body, wherein the skeleton portion has an anchor portion that functions as the joint portion and is disposed radially outward from an outer circumferential surface of the base material; The method of claim 14, wherein the implant body is deployed within the aneurysm, causing the anchor portion to penetrate the aneurysm wall and joining the implant body to the aneurysm wall.

16. preparing an anchor as the joint portion, which is provided separately from the implant body, and which penetrates the base material of the implant body from the inside of the base material and is driven into the aneurysm wall; The method of claim 14 , wherein the anchor is delivered by a delivery catheter to the interior of the substrate of the implant body disposed within the aneurysm.

17. preparing an adhesive to be applied to the outer peripheral surface of the implant body as the bonding portion; The method of claim 14 , wherein the adhesive is applied between the outer circumferential surface of the base material of the implant body disposed in the aneurysm and the aneurysm wall by a delivery catheter.

18. preparing the implant body, the framework of which has an outer diameter equal to or smaller than the diameter of the aneurysm in a natural state; the implant body deployed within the aneurysm is expanded using an expandable expander to a diameter greater than the outer diameter of the framework portion in its natural state, whereby the anchor portion is pierced into the aneurysm wall and the implant body is joined to the aneurysm wall; The method according to claim 13 or 15, wherein the diameter of the aneurysm is reduced by the force of the scaffold returning to its natural outer diameter.

19. The method of claim 12, wherein the implant body is deployed within the aneurysm such that the implant body is joined to the aneurysm wall at the maximum aneurysm diameter portion of the aneurysm by the joint.

20. 18. The method of any one of claims 14 to 17, wherein the implant body is deployed within the aneurysm such that the substrate occludes side branch vessels extending from the aneurysm.

21. The delivery catheter further includes an expandable and contractible expansion body at its tip and a fixing means for fixing the implant body on the contracted expansion body, The aneurysm treatment system according to claim 11 , wherein the expandable body has a maximum expanded diameter that is larger than the expanded diameter of the framework portion in the expanded state.

22. 2. The aneurysm treatment system according to claim 1, wherein a compound that reinforces vascular tissue is carried in a portion of the implant body that contacts the aneurysm wall so as to be releasable toward the aneurysm wall.

23. a compound that reinforces vascular tissue is carried on a portion of the implant body that comes into contact with the aneurysm wall; The method of claim 12 , wherein the compound is released toward the aneurysm wall from the portion of the implant body that is bonded to the aneurysm wall.

Images