Auxiliary occlusion device for aortic valve insufficiency

Abstract

The present invention provides an auxiliary occlusion device for aortic valve regurgitation. The auxiliary occlusion device comprises a positioning mechanism and an auxiliary occlusion member disposed proximal to the positioning mechanism. When the positioning mechanism is released, it is secured within the aorta, positioning the auxiliary occlusion member between the aortic valves. The auxiliary occlusion device can assist the aortic valve in occluding the gap between the aorta and the left ventricle in the presence of aortic valve regurgitation, thereby reducing or preventing blood backflow through the aortic valve. Furthermore, the auxiliary occlusion device does not obstruct blood flow in the aorta during ventricular contraction.

Description

Technical Field

[0001] The present invention relates to the field of medical devices, and in particular to an auxiliary occluding device for aortic valve insufficiency. Background Art

[0002] Backflow of blood from the aorta into the left ventricle due to aortic valve insufficiency is a serious health problem affecting millions of adults. The aortic valve is located on the left side of the heart, between the left ventricle and the aorta. During ventricular contraction, a healthy aortic valve opens to allow blood to flow from the left ventricle into the aorta. It closes during ventricular diastole to prevent backflow of blood from the aorta into the left ventricle. However, changes in the geometry of the aortic annulus can affect the function of the aortic valve, preventing it from closing completely during ventricular diastole, leading to backflow.

[0003] Currently, patients with aortic valve insufficiency typically undergo open-heart surgery to replace the incompletely closed valve with a prosthetic valve. However, open-heart surgery is highly invasive and, therefore, not suitable for many high-risk patients. In recent years, minimally invasive percutaneous aortic valve replacement (PAVR) has become available for aortic valve replacement. In this procedure, a stent-and-valve prosthesis is compressed to a smaller diameter and then delivered percutaneously to the aortic valve site. Once positioned correctly, the prosthesis is expanded to replace the function of the native aortic valve. While PAVR has shown great promise, challenges remain regarding delivery technology, paravalvular leaks, and valve durability. On the other hand, if the native aortic valve is still functional, repairing the aortic valve insufficiency rather than replacing it with a prosthetic valve offers significant advantages. Summary of the Invention

[0004] In view of this, an auxiliary closure device is provided that can assist the aortic valve to close during ventricular diastole to prevent blood in the aorta from flowing back into the left ventricle, thereby preventing aortic valve insufficiency. The specific technical solution is as follows.

[0005] An auxiliary occluding device for aortic valve insufficiency comprises a positioning mechanism and an auxiliary occluding piece arranged at the proximal end of the positioning mechanism. The positioning mechanism is fixed in the aorta when in a released state so that the auxiliary occluding piece is located between the aortic valves.

[0006] Preferably, the positioning mechanism and the auxiliary blocking member are an integral structure or a fixedly connected structure.

[0007] Preferably, during ventricular diastole, the aortic valve adheres to the outer surface of the auxiliary occluding member to seal and separate the aorta and the left ventricle, thereby preventing blood from flowing back from the aorta into the left ventricle.

[0008] Preferably, the positioning mechanism is a self-expanding structure or a balloon-expanding structure, so that it can be clamped on the inner wall of the aorta at the distal end of the aortic valve in a released state.

[0009] Preferably, the positioning mechanism includes an anchoring member, and the auxiliary blocking member is connected to the proximal end of the anchoring member.

[0010] Preferably, the positioning mechanism further includes a connecting member connected between the anchoring member and the auxiliary blocking member.

[0011] Preferably, the connecting member and the anchoring member are an integral structure or a fixed connection structure; or the connecting member and the auxiliary blocking member are an integral structure or a fixed connection structure; or the connecting member, the anchoring member and the auxiliary blocking member are an integral structure or all are fixed connection structures.

[0012] Preferably, the anchor is a self-expanding structure or a balloon-expanding structure, so that it can be clamped on the inner wall of the aorta at the distal end of the aortic valve in a released state.

[0013] Preferably, when the anchor is a self-expanding structure, the anchor includes at least one of an expanded frame structure, a coated stent or a bare stent, the frame structure includes a plurality of support members that are angularly spaced and axially extended; the coated stent includes a coating and an annular support frame fixed on the coating; the bare stent is a woven mesh stent or an integrally cut frame stent.

[0014] Preferably, the support members in the frame structure include a support proximal end, a support rod and a support distal end in sequence. The support proximal ends of multiple support members are gathered and fixed at the proximal end of the frame structure, the support distal ends of multiple support members are gathered and fixed at the distal end of the frame structure, and the support rods in all multiple support members are arranged at intervals to form an expansion body.

[0015] Preferably, the proximal ends of the supports of some of the multiple support members are gathered and fixed at the first proximal end of the frame structure, and the proximal ends of the supports of another part of the multiple support members are gathered and fixed at the second proximal end of the frame structure, wherein the first proximal end is arranged closer to the distal end of the frame structure than the second proximal end, and wherein the proximal ends of the supports of another part of the support members are connected to the auxiliary sealing member at the second proximal end.

[0016] Preferably, the supporting proximal ends of some of the supporting members are connected at the first proximal end with the supporting proximal ends of another part of the supporting members at the second proximal end through a first connecting rod.

[0017] Preferably, the supporting distal ends of some of the multiple support members are gathered and fixed at the first distal end of the frame structure, and the supporting distal ends of another part of the multiple support members are gathered and fixed at the second distal end of the frame structure, wherein the first distal end is arranged closer to the proximal end of the frame structure than the second distal end.

[0018] Preferably, the supporting distal ends of some of the supporting members are connected at the first distal end with the supporting distal ends of another part of the supporting members at the second distal end via a second connecting rod.

[0019] Preferably, the support rod in the support member is connected to the support proximal end in the adjacent support member through a third connecting rod.

[0020] Preferably, the connection between the support rod and the support proximal end in the support member is connected to the support proximal end in the adjacent support member through a third connecting rod.

[0021] Preferably, in the coated stent, the annular support frame includes at least one of an annular structure or a spiral structure, the annular structure refers to an annular structure composed of multiple first corrugated units connected end to end; the spiral structure refers to a tubular structure formed by multiple second corrugated units connected end to end and arranged in a continuous spiral.

[0022] Preferably, when the anchor is a bare stent, the bare stent includes a regular or irregular woven mesh stent or an integrally cut frame stent.

[0023] Preferably, the anchoring member includes an expandable frame structure and a coated stent, the frame structure is fixed inside the coated stent, and the frame structure is fixedly connected to the annular support frame in the coated stent or fixedly connected to the coating in the coated stent.

[0024] Preferably, when the anchor is a balloon-type expansion structure, the balloon-type expansion structure includes an inner membrane wall and an outer membrane wall, and the outer membrane wall and the inner membrane wall are sealed and connected to form a middle cavity sac, wherein the radius of the inner membrane wall is smaller than the radius of the outer membrane wall.

[0025] Preferably, the auxiliary blocking member is in a cylindrical, elliptical, curved cylindrical or flat spindle shape.

[0026] Preferably, the cross-sectional area of ​​the auxiliary sealing member is smaller than the flow area through the aortic valve annulus.

[0027] Preferably, the auxiliary blocking member includes a proximal portion and a distal portion, wherein the distal portion is used to connect with the positioning mechanism, and the radial radius of the proximal portion is greater than the radial radius of the distal portion.

[0028] Preferably, at least the outer surface of the auxiliary sealing member is made of an impermeable material.

[0029] Preferably, the auxiliary blocking member is a solid structure or a hollow structure, and both ends of the hollow structure are sealed structures so that the fluid cannot pass through the proximal end and the distal end of the auxiliary blocking member.

[0030] Preferably, the anchoring member and the auxiliary blocking member are connected by a linear connecting member; the connecting member includes a plurality of fourth connecting rods, the distal ends of the fourth connecting rods are fixedly connected to the proximal end or distal end of the anchoring member, and the proximal ends of the fourth connecting rods are gathered and fixedly connected to the distal end of the auxiliary blocking member.

[0031] Preferably, when the distal ends of the fourth connecting rods are fixedly connected to the proximal ends of the anchoring members, the distal ends of the fourth connecting rods are equidistantly distributed and fixedly connected to the proximal ends of the anchoring members.

[0032] Preferably, the connecting member has rigidity in the released state, so that the anchoring member and the auxiliary blocking member are in a relatively stable fixed position.

[0033] Preferably, the auxiliary blocking device includes a recovery head, which is arranged at the distal end of the auxiliary blocking device, and the recovery head and the anchor are an integral structure or a fixed connection structure.

[0034] Preferably, the recovery head comprises a hook or a lasso.

[0035] Preferably, when the recovery head is a hook body, the hook body is connected to the distal end of the anchor member through a fifth connecting rod or is directly fixed to the distal end of the anchor member; when the recovery head is a lasso, the lasso includes a connecting part and a hook part, the connecting part is fixed to the distal end of the anchor member, and the hook part extends from the connecting part to the distal end of the auxiliary sealing device.

[0036] Preferably, when the recovery head is a hook body, the hook body is connected to the distal end of the anchor member through a fifth connecting rod, and the auxiliary blocking member is connected to the fifth connecting rod through a fourth connecting rod.

[0037] Preferably, the connecting portion of the lasso is fixed around the distal end of the anchor.

[0038] Beneficial effects of the present invention: The auxiliary occlusion device provided by the present invention can assist the aortic valve in occluding the gap between the aorta and the left ventricle in the case of aortic valve insufficiency, so as to reduce or avoid blood backflow through the aortic valve, and the auxiliary occlusion device will not hinder the circulation of blood in the aorta when the ventricle contracts. BRIEF DESCRIPTION OF THE DRAWINGS

[0039] Figure 1 A schematic structural diagram of an auxiliary occluding device for aortic valve insufficiency provided in the first embodiment of the present invention.

[0040] Figure 2 The present invention provides Figure 1 Schematic diagram of the application of auxiliary occlusion device in interventional treatment of aortic valve regurgitation.

[0041] Figure 3 This is a structural schematic diagram of an auxiliary blocking device provided in the second embodiment of the present invention.

[0042] Figure 4 This is a schematic structural diagram of an auxiliary blocking device provided in the third embodiment of the present invention.

[0043] Figure 5 This is a structural schematic diagram of an auxiliary blocking device provided in the fourth embodiment of the present invention.

[0044] Figure 6 This is a structural schematic diagram of an auxiliary blocking device provided in the fifth embodiment of the present invention.

[0045] Figure 7 The present invention provides Figure 5 Schematic diagram of the application of auxiliary occlusion device in interventional treatment of aortic valve regurgitation.

[0046] Figure 8 This is a structural schematic diagram of an auxiliary blocking device provided in the sixth embodiment of the present invention.

[0047] Figure 9 This is a structural schematic diagram of an auxiliary blocking device provided in the seventh embodiment of the present invention.

[0048] Figure 10 This is a structural schematic diagram of an auxiliary blocking device provided in the eighth embodiment of the present invention.

[0049] Figure 11 This is a structural schematic diagram of an auxiliary blocking device provided in the ninth embodiment of the present invention.

[0050] Figure 12 The present invention provides Figure 11 Schematic diagram of the application of auxiliary occlusion device in interventional treatment of aortic valve regurgitation.

[0051] Figure 13 This is a structural schematic diagram of an auxiliary blocking device provided in the tenth embodiment of the present invention.

[0052] Figure 14 This is a schematic diagram of an auxiliary sealing member with a circular cross-section in an aortic valve provided by the present invention.

[0053] Figure 15 This is a schematic diagram of an auxiliary occluding member with an elliptical cross-section in an aortic valve provided by the present invention.

[0054] Figure 16 This is a structural schematic diagram of an auxiliary blocking device provided in the eleventh embodiment of the present invention.

[0055] Figure 17 This is a structural schematic diagram of an auxiliary blocking device provided in the twelfth embodiment of the present invention.

[0056] Figure 18 This is a structural schematic diagram of an auxiliary blocking device provided in the thirteenth embodiment of the present invention.

[0057] Figure 19 This is a structural schematic diagram of an auxiliary blocking device provided in the fourteenth embodiment of the present invention. DETAILED DESCRIPTION

[0058] The following is a preferred embodiment of the present invention. It should be noted that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principles of the present invention. These improvements and modifications are also considered to be within the scope of protection of the present invention.

[0059] In the present description, the "proximal end" refers to the end closest to the left ventricle of the heart, and the "distal end" refers to the end farther from the left ventricle. Axial refers to the direction of the auxiliary occlusion device's central axis, while radial refers to the direction perpendicular to the central axis. These definitions are for convenience only and are not to be construed as limiting the present invention.

[0060] See also Figure 1The first embodiment of the present invention provides an auxiliary occluding device 10 for aortic valve insufficiency. The auxiliary occluding device 10 includes a positioning mechanism 20 and an auxiliary occluding member 200 disposed at the proximal end of the positioning mechanism 20. The positioning mechanism 20 is fixed in the aorta when in the released state, and is used to position the auxiliary occluding device 10 in the aorta so that the auxiliary occluding member 200 is located between the aortic valves. The positioning mechanism 20 and the auxiliary occluding member 200 are an integral structure or a fixed connection structure. The positioning mechanism 20 is a self-expanding structure or a balloon-expanding structure so that the positioning mechanism 20 can be clamped on the inner wall of the aorta distal to the aortic valve in the released state. During ventricular diastole, the aortic valve adheres to the outer surface of the auxiliary occluding member 200 to seal and separate the aorta and the left ventricle, thereby preventing blood from flowing back from the aorta into the left ventricle.

[0061] In this embodiment, the positioning mechanism 20 includes an anchor 100 and a connector 300. The auxiliary blocking member 200 is connected to the proximal end of the anchor 100. Specifically, the auxiliary blocking member 200 is located at the proximal end of the anchor 100 through the connector 300. The anchor 100 and the auxiliary blocking member 200 are an integral structure or connected through the connector 300. Figure 1 The anchoring member 100 and the auxiliary blocking member 200 are connected via a connecting member 300. Figure 3 and Figure 4 The anchoring member 100 and the auxiliary sealing member 200 are integrated into one structure. When released, the anchoring member 100 can be clamped onto the inner wall of the aorta distal to the aortic valve, while the auxiliary sealing member 200 can be inserted between the aortic valves and assist in sealing the pores formed by aortic valve insufficiency during ventricular diastole.

[0062] See also Figure 2 The connector 300 connects the auxiliary occluding member 200 to the anchoring member 100. Specifically, the connector 300 is connected to the anchoring member 100 and the auxiliary occluding member 200, respectively, by welding, suturing, or the like. The anchoring member 100 is an expandable structure. When the positioning mechanism 20 (anchoring member 100) is placed in the ascending aorta segment D1, it acts as an anchor relative to the auxiliary occluding member 200. At this point, the auxiliary occluding member 200 can be accurately released between the three leaflets of the aortic valve D2, forming a tight fit with the three leaflets during ventricular expansion, thereby sealing the aorta and left ventricle, reducing or preventing blood backflow through the aortic valve. During ventricular contraction, blood can flow through the anchoring member 100.

[0063] The auxiliary occlusion device 10 for aortic valve closure provided by the present invention can assist the aortic valve in occluding the gap between the aorta and the left ventricle in the case of aortic valve insufficiency, so as to reduce or avoid blood backflow through the aortic valve, and the auxiliary occlusion device 10 will not hinder the circulation of blood in the aorta when the ventricle contracts.

[0064] In a further embodiment, the connecting member 300 and the anchor member 100 are an integral structure or a fixed connection structure (see Figure 1 、 Figure 16 and Figure 19 Alternatively, the connecting member 300 and the auxiliary blocking member 200 may be an integral structure or a fixed connection structure (see Figure 17 and Figure 18 ). Alternatively, the connecting member 300, the anchoring member 100 and the auxiliary blocking member 200 may be an integrated structure or all of them may be fixedly connected (see Figure 1 The connecting member 300 is connected to the anchor member 100 and the auxiliary blocking member 200 in the above-mentioned multiple ways, so that the structure of the device 10 provided by the present invention is more diverse and the device 10 can be made more stable. The selection according to the specificity of the individual condition can achieve better application effect.

[0065] In a further embodiment, the anchor 100 is a self-expanding structure (see Figure 1 、 Figure 3 and Figure 5 ) or balloon-type expansion structure (see Figure 13 ) so that it can be snapped onto the inner wall of the aorta distal to the aortic valve when released. A self-expanding structure or a balloon-expandable structure allows the anchor 100 to be in a contracted state before entering the aorta, which facilitates the entry of the entire auxiliary occlusion device 10 into the aorta. Once the auxiliary occlusion device 10 has entered a suitable position in the aorta, such as above the coronary artery ostium, the anchor 100 begins to expand. The outward self-expansion force of the anchor 100 allows the anchor 100 to be fixed to the vessel wall above the coronary artery ostium.

[0066] See also Figure 3 、 Figure 5 and Figure 8 In a further embodiment, when the anchor 100 is a self-expanding structure, the anchor 100 includes at least one of an expandable frame structure 400, a stent graft 500, or a bare stent 600. The frame structure 400 includes a plurality of angularly spaced and axially extending support members 410 (see FIG. Figure 3 The stent graft 500 includes a graft 510 and an annular support frame 520 fixed on the graft 510 (see Figure 5 The bare stent 600 is a woven mesh stent or an integrally cut frame stent (see Figure 8 ).

[0067] See also Figure 3The second embodiment of the present invention provides an auxiliary occlusion device 10a, in which the anchor 100 adopts a frame structure 400. The support member 410 in the frame structure 400 includes a support proximal end 411, a support rod 412 and a support distal end 413 in sequence. The support proximal ends 411 in a plurality of support members 410 are gathered and fixed at the proximal end of the frame structure 400, and the support distal ends 413 in a plurality of support members 410 are gathered and fixed at the distal end of the frame structure 400. The support rods 412 in all the support members 410 are arranged at an angle to form an expandable body. That is to say, the frame structure 400 is roughly a structure with small ends and a large middle. The expandable body formed by the support rods 412 is used to support the lumen wall of the aorta during expansion. It can be understood that the support member 410 is made of a material with shape memory, such as nickel-titanium alloy. After the anchoring member 100 of the frame structure 400 is delivered to the lumen, the frame structure 400 can be restored to its expanded state after being released from the delivery sheath of the conveyor, so that at least part of the radial support rods 412 are in contact with the inner wall of the lumen. The expansion body formed by the support rods 412 is cylindrical, and the diameter of the cylindrical expansion body is larger than the diameter of the lumen. The anchoring member 100 is fixed in the lumen by the support rods 412 in the support members 410 fitting with the inner wall of the lumen. It can be understood that the number of support members 410 can be set according to actual needs, and the angle between the support rods 412 in two adjacent support members 410 is determined according to the number of support members 410, and is preferably spaced at a uniform angle so that the force around the cylindrical expansion body is uniform.

[0068] The support proximal end 411 of the support member 410 may be fixed together in an integral structure or by using a fixing member 414. Similarly, the support distal end 413 of the support member 410 may be fixed together in an integral structure or by using a fixing member.

[0069] See also Figure 4 A third embodiment of the present invention provides an auxiliary blocking device 10b. In the auxiliary blocking device 10b, the proximal support ends 411 of some of the multiple support members 410 are gathered and fixed at the first proximal end J1 of the frame structure 400, and the proximal support ends 411 of another portion of the multiple support members 410 are gathered and fixed at the second proximal end J2 of the frame structure 400. The first proximal end J1 is located closer to the distal end of the frame structure 400 than the second proximal end J2, and the proximal support ends 411 of another portion of the support members 410 are connected to the auxiliary blocking member 200 at the second proximal end J2. In this embodiment, the proximal support ends 411 of some of the support members 410 are gathered and fixed, and then the proximal support ends 411 of another portion of the support members 410 are gathered and fixed, so as to make the structure of the support members 410 more stable.

[0070] In a further embodiment, the supporting proximal end 411 of a partial support member 410 is connected at the first proximal end J1 to the supporting proximal end 411 of another partial support member 410 at the second proximal end J2 via a first connecting rod 701. Connecting the supporting proximal ends 411 at the first proximal end J1 and the second proximal end J2 via the first connecting rod 701 makes it easier to control the expanded shape of the anchor member 100 during expansion.

[0071] In a further embodiment, the distal ends 413 of some of the plurality of support members 410 are gathered and fixed at the first distal end Y1 of the frame structure 400, and the distal ends 413 of another portion of the plurality of support members 410 are gathered and fixed at the second distal end Y2 of the frame structure 400, wherein the first distal end Y1 is positioned closer to the proximal end of the frame structure 400 than the second distal end Y2. Gathering and fixing the distal ends 413 of some of the support members 410, and then gathering and fixing the distal ends 413 of another portion of the support members 410, makes the structure of the support members 410 more stable.

[0072] In a further embodiment, the support distal end 413 of a portion of the support member 410 is connected at the first distal end Y1 to the support distal end 413 of another portion of the support member 410 at the second distal end Y2 via a second connecting rod 702. Connecting the support distal ends 413 at the first distal end Y1 and the second distal end Y2 via the second connecting rod 702 makes it easier to control the expanded shape of the anchor member 100 during expansion.

[0073] In a further embodiment, the support rod 412 in the support member 410 is connected to the support proximal end 411 in the adjacent support member 410 via a third connecting rod 703, so as to make the anchor member 100 of the frame structure 400 more stable.

[0074] In a further embodiment, the connection 414 between the support rod 412 and the support proximal end 411 of the support member 410 is connected to the support proximal end 411 of the adjacent support member 410 via a third connecting rod 703, thereby further stabilizing the anchor member 100 of the frame structure 400.

[0075] In some embodiments, in the support member 410, the support distal end 413 further includes an extension segment 415, which extends from the distal end of the support distal end 413 to the proximal end, and is disposed at the connection between the support distal end 413 and the support rod 412. When the framework structure 400 of this embodiment is placed in the aorta and self-expands, the extension segment 415 can further support the lumen wall, allowing the anchor 100 of the framework structure 400 to be more stably anchored in the lumen wall of the aorta.

[0076] See also Figure 5 and Figure 6The fourth embodiment of the present invention provides an auxiliary occlusion device 10c and the fifth embodiment provides an auxiliary occlusion device 10d. In the stent graft 500, the annular support frame 520 includes an annular structure 530 (see Figure 5 ) or the helical structure 540 (see Figure 6 ), the annular structure 530 is an annular structure composed of a plurality of first wave units 531 connected end to end. The spiral structure 540 is a tubular structure formed by a plurality of second wave units 541 connected end to end and arranged in a continuous spiral.

[0077] It is understood that when the annular support frame 520 includes only the annular structure 530, there may be multiple annular structures 530. When the annular support frame 520 includes only the spiral structure 540, there may be only one or multiple spiral structures 540. It is understood that the annular support frame 520 may also be composed of both the annular structure 530 and the spiral structure 540.

[0078] See also Figure 5 and Figure 7 In a further embodiment, the annular support frame 520 includes a plurality of annular structures 530, and the inner diameters of each annular structure 530 when expanded are equal or differ by a first predetermined range. This ensures that the entire annular support frame 520 provides a more uniform support force on the lumen wall after expansion. It is understood that the inner diameters of the annular structures 530 in the annular support frame 520 when expanded can also be set based on the inner diameter of the lumen wall to ensure that the annular support frame 520 better matches the lumen wall during expansion and provides a more stable fixation.

[0079] In a further embodiment, the wavelengths of the first waveform units 531 in each annular structure 530 are equal or differ by a second predetermined range. When the wavelengths are equal, the crests and troughs of two adjacent annular structures 530 correspond to each other, thereby increasing flexibility and improving the conformity of the annular support frame 520 of the annular structure 530 to the aorta.

[0080] In some embodiments, the radial radius of the stent graft 500 when expanded is slightly larger than the lumen diameter of the aorta, so that the anchor 100 of the stent graft 500 can be anchored in the ascending aorta segment.

[0081] In a further embodiment, in the stent graft 500, the coating 510 is disposed on the inner side and / or outer side of the annular support frame 520. The coating 510 may be made of a polymer material with excellent biocompatibility, such as expanded polytetrafluoroethylene, PET, polyester, polyurethane, silicone, ultra-high molecular weight polyethylene, or other suitable materials.

[0082] See also Figures 8 to 10In some embodiments, when the anchor 100 is a bare stent 600, the bare stent 600 includes a regular or irregular woven mesh stent or an integrally cut frame stent. The woven mesh stent is woven from support strips 610.

[0083] Among them, regular woven mesh stents such as Figures 8 to 10 As shown. Figure 8 In the sixth embodiment of the present invention, the auxiliary blocking device 10e is shown to have a denser grid structure. Figure 9 In the seventh embodiment, the auxiliary blocking device 10f provided has a relatively sparse grid structure. Figure 10 In the eighth embodiment, the auxiliary occlusion device 10g is provided with mutually perpendicular support strip structures. By providing these diverse bare stents, it is possible to achieve more personalized treatment for aortic valve regurgitation in different conditions.

[0084] It is understandable that when the coating 510 in the coated stent 500 is removed, the annular support frame 520 can also be called a bare stent 600, that is, the bare stent 600 can also be composed of an annular structure 530 or a spiral structure 540.

[0085] In some embodiments, the bare stent 600 may be cylindrical, and the radial radius of the cylindrical bare stent 600 when expanded is slightly larger than the lumen diameter of the aorta, so that the anchor 100 of the bare stent 600 can be anchored in the ascending aorta segment.

[0086] See also Figure 11 The ninth embodiment of the present invention provides an auxiliary occlusion device 10h. In the auxiliary occlusion device 10h, the anchor 100 includes an expandable frame structure 400 and a stent graft 500. The frame structure 400 is fixed inside the stent graft 500, and the frame structure 400 is fixedly connected to the annular support frame 520 in the stent graft 500 or to the graft 510 in the stent graft 500. It is understood that the graft 500 in this embodiment can be set longer (see Figure 12 ) so that the stent graft 500 can extend to the position of the aortic arch D3, so that the anchor 100 can be more stably fixed in the lumen wall of the aorta.

[0087] The frame structure 400 is disposed at the proximal end of the stent graft 500. That is, the frame structure 400 and the stent graft 500 are fixed to the aortic lumen wall near the aortic valve, so that when the ventricle contracts, blood flows from the aortic valve into the aorta and impacts the anchor 100 without affecting the anchor 100's support on the lumen wall.

[0088] See also Figure 13The tenth embodiment of the present invention provides an auxiliary occlusion device 10i. In this auxiliary occlusion device 10i, the anchor 100 is a balloon-type expandable structure 800. The balloon-type expandable structure 800 includes an intimal wall 810 and an adventitia wall 820. The adventitia wall 820 and the intimal wall 810 are sealed together to form a lumen sac 830. The radius of the intimal wall 810 is smaller than that of the adventitia wall 820. A channel T for blood circulation is formed in the center of the intimal wall 510. The lumen sac 830 expands when the anchor 100 expands to support the lumen wall.

[0089] In a further embodiment, the auxiliary blocking member 200 is in a cylindrical, elliptical, curved cylindrical or flat spindle shape. Figure 14 As shown, the cross section of the cylindrical auxiliary blocking member 200 is circular. Figure 15 As shown, the cross section of the elliptical cylindrical auxiliary blocking member 200 is elliptical.

[0090] In a further embodiment, the cross-sectional area of ​​the auxiliary occluding member 200 is smaller than the flow area through the aortic valve annulus, so that the auxiliary occluding member 200 does not substantially obstruct the flow of blood through the aortic valve during ventricular contraction.

[0091] See also Figure 16 The eleventh embodiment of the present invention provides an auxiliary blocking device 10j, in which the auxiliary blocking member 200 includes a proximal portion 210 and a distal portion 220, wherein the distal portion 220 is used to connect with the positioning mechanism 20. Specifically, the distal portion 220 is used to connect with the anchor 100 or the connector 300. Figure 16 FIG2 shows an embodiment in which the distal portion 220 is connected to the connector 300. The radial radius of the proximal portion 210 is larger than the radial radius of the distal portion 220. The proximal portion 210 is used to release and form a tight seal with the three leaflets of the aortic valve when the ventricle is dilated, thereby reducing or preventing blood backflow through the aortic valve.

[0092] In a further embodiment, at least the outer surface of the auxiliary sealing member 200 is made of an impermeable material to prevent blood from penetrating into the auxiliary sealing member 200 .

[0093] In some embodiments, the surface of the auxiliary sealing member 200 is compliant and can form a tight seal with the leaflet.

[0094] In some embodiments, the surface of the auxiliary occluding member 200 includes a biocompatible material to prevent possible wear on the leaflet when the surface of the auxiliary occluding member 200 engages with the leaflet.

[0095] In some embodiments, the auxiliary blocking member 200 has a predetermined rigidity so as to maintain its expanded shape, and has a predetermined elasticity and / or flexibility so as to be closely coupled with the leaflet.

[0096] It is understandable that the auxiliary sealing member 200 can be made of high molecular polymer material, metal or other biocompatible materials suitable for implantation into the body.

[0097] In further embodiments, the auxiliary sealing member 200 has a solid or hollow structure, with both ends of the hollow structure being sealed to prevent fluid from passing through the proximal and distal ends of the auxiliary sealing member 200. Auxiliary sealing members 200 with hollow structures are lighter and less likely to fall out or slide when placed in the aorta.

[0098] See also Figure 1 、 Figure 16 、 Figure 17 and Figure 18 In some embodiments, the anchor 100 and the auxiliary blocking member 200 are connected by a linear connector 300. The connector 300 includes a plurality of fourth connecting rods 310, the distal ends of the fourth connecting rods 310 are fixedly connected to the proximal end or distal end of the anchor 100, and the proximal ends of the fourth connecting rods 310 are gathered and fixedly connected to the distal end of the auxiliary blocking member 200. Figure 1 and Figure 16 In the embodiment, the distal end of the connecting member 300 is fixedly connected to the proximal end of the anchor member 100. Figure 17 and Figure 18 In the embodiment, the distal end of the fourth connecting rod 310 is fixedly connected to the distal end of the anchor 100. Figure 18 In the auxiliary sealing member device 101 provided in the thirteenth embodiment of the present invention, the fourth connecting rod 310 is directly connected to the recovery hook body 910 at the distal end of the anchor member 100, that is, in this embodiment, the auxiliary sealing member 200 and the anchor member 100 are both connected to the hook body 910. When the auxiliary sealing member 101 is recovered and removed, the hook body 910 pulls the auxiliary sealing member 200 and the anchor member 100 back and out quickly.

[0099] In a further embodiment, when the distal ends of the fourth connecting rods 310 are fixedly connected to the proximal end of the anchor 100, the distal ends of the fourth connecting rods 310 are evenly distributed and fixedly connected to the proximal end of the anchor 100. This makes the fourth connecting rods 310 in the connecting member 300 more evenly arranged, which is more conducive to fixing the connecting rods 300 to the anchor 100.

[0100] See also Figure 17In the auxiliary occlusion device 10k provided in the twelfth embodiment of the present invention, when the distal end of the fourth connecting rod 310 is fixedly connected to the distal end of the anchor 100, the fourth connecting rod 310 can be connected to the recovery head 900 connected to the distal end of the anchor 100. Figure 17 In the embodiment, the recovery head 900 includes a hook body 910 and a fifth connecting rod 930 , wherein the fourth connecting rod 310 is connected to the fifth connecting rod 930 .

[0101] In a further embodiment, the connector 300 is made of metal, polymer or other biocompatible materials, preferably memory alloy, such as nickel-titanium alloy.

[0102] In a further embodiment, the connecting member 300 is rigid in the released state so that the anchoring member 100 and the auxiliary blocking member 200 are in a relatively stable fixed position.

[0103] Please refer again Figure 1 In a further embodiment, the auxiliary occlusion device 10 includes a retrieval head 900, which is disposed at the distal end of the auxiliary occlusion device 10 and is integrally formed with or fixedly connected to the anchor 100. The retrieval head 900 is used to remove the entire device 10 from the aorta, thereby achieving retrievability.

[0104] See also Figure 17 、 Figure 18 and Figure 19 In a further embodiment, the recovery head 900 includes a hook 910 or a lasso 920. Figure 17 and Figure 18 FIG. 8 shows an embodiment in which the recovery head 900 adopts a hook body 910 . Figure 19 An embodiment employing a lasso 920 is shown in FIG.

[0105] In a further embodiment, when the recovery head 900 is a hook body 910, the hook body 910 is connected to the distal end of the anchor member 100 via a fifth connecting rod 930 (see Figure 17 ) or directly fixed to the distal end of the anchor 100 (see Figure 3 、 Figure 4 and Figure 18 In a further embodiment, when the recovery head 900 is a hook body 910, the hook body 910 is connected to the distal end of the anchor member 100 via a fifth connecting rod 930, and the auxiliary blocking member 200 is connected to the fifth connecting rod 930 via a fourth connecting rod 310 (see Figure 17 ).

[0106] See also Figure 19In the auxiliary occlusion device 10m provided in the fourteenth embodiment of the present invention, when the retrieval head 900 is a lasso 920, the lasso 920 includes a connecting portion 921 and a hook portion 922. The connecting portion 921 is fixed to the distal end of the anchor 100, and the hook portion 922 extends from the connecting portion 921 toward the distal end of the auxiliary occlusion device 10. In this embodiment, the hook portion 922 of the lasso 920 is used to hook the auxiliary occlusion device 10 at a position where it is hooked by an external device during retrieval. By hooking the hook portion 922 and then forcibly pulling it out, since the connecting portion 921 is fixed to the distal end of the anchor 100, when the hook portion 922 is pulled out, the entire device 10 is pulled out through the connecting portion 921.

[0107] In a further embodiment, a connecting portion 921 in the lasso 920 is fixed around the distal end of the anchor 100. The connecting portion 921 is fixed around the distal end of the anchor 100 so that the lasso 920 can more conveniently and smoothly remove the anchor 100 when the device 10 is pulled out.

[0108] In any of the above embodiments, the anchor 100 is made of a metal material, polymer material or other biocompatible material having expansion properties and / or elasticity, preferably made of at least one of stainless steel, titanium, shape memory alloy or other biocompatible metals.

[0109] The above-described embodiments merely illustrate several implementations of the present invention, and while their descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the present invention. It should be noted that a person skilled in the art would be able to make numerous variations and improvements without departing from the spirit of the present invention, all of which fall within the scope of protection of the present invention. Therefore, the scope of protection of the present invention shall be determined by the appended claims.

Claims

1. An auxiliary occlusion device for aortic valve insufficiency, characterized in that: The auxiliary blocking device includes a positioning mechanism and an auxiliary blocking piece arranged at the proximal end of the positioning mechanism. The positioning mechanism is fixed in the aorta when in a released state so that the auxiliary blocking piece is located between the aortic valves. The auxiliary blocking piece is cylindrical and includes a proximal end and a distal end, wherein the distal end is used to connect with the positioning mechanism. The radial radius of the proximal end is greater than the radial radius of the distal end. The auxiliary blocking piece is a hollow structure, and both ends of the hollow structure are closed structures so that fluid cannot pass through the proximal and distal ends of the auxiliary blocking piece.

2. The auxiliary blocking device according to claim 1, characterized in that: The positioning mechanism and the auxiliary blocking member are an integral structure or a fixedly connected structure.

3. The auxiliary blocking device according to claim 1, characterized in that: During ventricular diastole, the aortic valve adheres to the outer surface of the auxiliary occluding member to seal and separate the aorta and the left ventricle, thereby preventing blood from flowing back from the aorta into the left ventricle.

4. The auxiliary blocking device according to claim 1, characterized in that: The positioning mechanism is a self-expanding structure or a balloon-expanding structure, so that it can be clamped on the inner wall of the aorta at the distal end of the aortic valve in a released state.

5. The auxiliary blocking device according to claim 1, characterized in that: The positioning mechanism includes an anchoring member, and the auxiliary blocking member is connected to the proximal end of the anchoring member.

6. The auxiliary blocking device according to claim 5, characterized in that: The positioning mechanism further includes a connecting member connected between the anchoring member and the auxiliary blocking member.

7. The auxiliary blocking device according to claim 6, characterized in that: The connecting piece and the anchoring piece are an integral structure or a fixed connection structure; or the connecting piece and the auxiliary blocking piece are an integral structure or a fixed connection structure; or the connecting piece, the anchoring piece and the auxiliary blocking piece are an integral structure or all are fixed connection structures.

8. The auxiliary blocking device according to claim 5 or 6, characterized in that: The anchor is a self-expanding structure or a balloon-expanding structure, so that it can be clamped on the inner wall of the aorta at the distal end of the aortic valve in a released state.

9. The auxiliary blocking device according to claim 8, characterized in that: When the anchor is a self-expanding structure, the anchor includes at least one of an expanded frame structure, a coated stent or a bare stent, and the frame structure includes a plurality of support members that are angularly spaced and axially extended; the coated stent includes a coating and an annular support frame fixed on the coating; the bare stent is a woven mesh stent or an integrally cut frame stent.

10. The auxiliary blocking device according to claim 9, characterized in that: The support members in the frame structure include a support proximal end, a support rod and a support distal end in sequence. The support proximal ends of multiple support members are gathered and fixed at the proximal end of the frame structure, and the support distal ends of multiple support members are gathered and fixed at the distal end of the frame structure. The support rods in all multiple support members are arranged at intervals to form an expansion body.

11. The auxiliary blocking device according to claim 10, characterized in that: The proximal ends of the supports of some of the multiple support members are gathered and fixed at the first proximal end of the frame structure, and the proximal ends of the supports of another part of the multiple support members are gathered and fixed at the second proximal end of the frame structure, wherein the first proximal end is arranged closer to the distal end of the frame structure than the second proximal end, and the proximal ends of the supports of another part of the support members are connected to the auxiliary sealing member at the second proximal end.

12. The auxiliary blocking device according to claim 11, characterized in that: The supporting proximal ends of some of the supporting members are connected at the first proximal end with the supporting proximal ends of another part of the supporting members at the second proximal end through a first connecting rod.

13. The auxiliary blocking device according to claim 10, characterized in that: The supporting distal ends of some of the multiple support members are gathered and fixed at the first distal end of the frame structure, and the supporting distal ends of another part of the multiple support members are gathered and fixed at the second distal end of the frame structure, wherein the first distal end is arranged closer to the proximal end of the frame structure than the second distal end.

14. The auxiliary blocking device according to claim 13, characterized in that: The supporting distal ends of some of the supporting members are connected at the first distal end with the supporting distal ends of another part of the supporting members at the second distal end through a second connecting rod.

15. The auxiliary blocking device according to claim 10, characterized in that: The support rod in the support member is connected to the support proximal end in the adjacent support member through a third connecting rod.

16. The auxiliary blocking device according to claim 10, characterized in that: The connection between the support rod and the support proximal end in the support member is connected to the support proximal end in the adjacent support member through a third connecting rod.

17. The auxiliary blocking device according to claim 9, characterized in that: In the coated stent, the annular support frame includes at least one of an annular structure or a spiral structure. The annular structure refers to an annular structure composed of multiple first corrugated units connected end to end; the spiral structure refers to a tubular structure formed by multiple second corrugated units connected end to end and arranged in a continuous spiral.

18. The auxiliary blocking device according to claim 9, characterized in that: When the anchor is a bare stent, the bare stent includes a regular or irregular woven mesh stent or an integrally cut frame stent.

19. The auxiliary blocking device according to claim 9, characterized in that: The anchoring member includes an expandable frame structure and a coated stent. The frame structure is fixed inside the coated stent, and the frame structure is fixedly connected to the annular support frame in the coated stent or fixedly connected to the coating in the coated stent.

20. The auxiliary blocking device according to claim 8, wherein: When the anchor is a balloon-type expansion structure, the balloon-type expansion structure includes an inner membrane wall and an outer membrane wall, the outer membrane wall and the inner membrane wall are sealed to form a middle cavity balloon, wherein the radius of the inner membrane wall is smaller than the radius of the outer membrane wall.

21. The auxiliary blocking device according to claim 1, wherein: At least the outer surface of the auxiliary sealing member is made of an impermeable material.

22. The auxiliary blocking device according to claim 6, characterized in that: The anchoring member and the auxiliary blocking member are connected by a linear connecting member; the connecting member includes a plurality of fourth connecting rods, the distal ends of the fourth connecting rods are fixedly connected to the proximal end or distal end of the anchoring member, and the proximal ends of the fourth connecting rods are gathered and fixedly connected to the distal end of the auxiliary blocking member.

23. The auxiliary blocking device according to claim 22, characterized in that: When the distal ends of the fourth connecting rods are fixedly connected to the proximal end of the anchor, the distal ends of the fourth connecting rods are evenly distributed and fixedly connected to the proximal end of the anchor.

24. The auxiliary blocking device according to claim 6, characterized in that: The connecting member has rigidity in the released state, so that the anchoring member and the auxiliary blocking member are in a relatively stable fixed position.

25. The auxiliary blocking device according to claim 5 or 6, characterized in that: The auxiliary blocking device includes a recovery head, which is arranged at the distal end of the auxiliary blocking device. The recovery head and the anchor are an integral structure or a fixed connection structure.

26. The auxiliary blocking device according to claim 25, characterized in that: The recovery head includes a hook or a lasso.

27. The auxiliary blocking device according to claim 26, characterized in that: When the recovery head is a hook body, the hook body is connected to the distal end of the anchor member through a fifth connecting rod or is directly fixed to the distal end of the anchor member; when the recovery head is a lasso, the lasso includes a connecting part and a hook part, the connecting part is fixed to the distal end of the anchor member, and the hook part extends from the connecting part to the distal end of the auxiliary sealing device.

28. The auxiliary blocking device according to claim 26, characterized in that: When the recovery head is a hook body, the hook body is connected to the distal end of the anchor member through a fifth connecting rod, and the auxiliary blocking member is connected to the fifth connecting rod through a fourth connecting rod.

29. The auxiliary blocking device according to claim 27, characterized in that: The connecting portion of the lasso is secured around the distal end of the anchor.

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