CN209966452U - Auxiliary plugging device for incomplete closure of aortic valve - Google Patents

Abstract

The utility model provides an auxiliary blocking device for aortic valve insufficiency. The auxiliary blocking device comprises a positioning mechanism and an auxiliary blocking member arranged at the proximal end of the positioning mechanism. The positioning mechanism is released when the positioning mechanism is released. In the state, it is fixed in the aorta, so that the auxiliary occluder is located between the aortic valves. The auxiliary blocking device provided by the utility model can assist the aortic valve to block the pores between the aorta and the left ventricle under the condition of incomplete aortic valve regurgitation, so as to reduce or avoid the backflow of blood through the aortic valve. When the auxiliary occlusion device does not obstruct the flow of blood in the aorta.

Description

An auxiliary occlusion device for aortic valve insufficiency

technical field

The utility model relates to the field of medical devices, in particular to an auxiliary blocking device for aortic valve insufficiency.

Background technique

Aortic regurgitation into the left ventricle due to aortic valve insufficiency is a serious problem that affects the health of millions of adults. The aortic valve is located on the left side of the heart, between the left ventricle and the aorta. When the ventricle contracts, the healthy aortic valve opens to allow blood to flow from the left ventricle into the aorta; the aortic valve closes during ventricular diastole to prevent backflow of blood from the aorta into the left ventricle. However, when the geometry of the aortic annulus changes, it may affect the functionality of the aortic valve, such that the aortic valve may not fully close during ventricular diastole, resulting in regurgitation.

Currently, open heart surgery is commonly used for patients with aortic regurgitation, in which a prosthetic valve is used to replace the valve that does not fully close. Not applicable. In recent years, minimally invasive percutaneous aortic valve replacement (PAVR) has been used to replace the aortic valve. The small diameter is then delivered percutaneously to the site of the aortic valve, and after entering the correct treatment site, the prosthetic prosthesis is expanded to replace the function of the native aortic valve. Although percutaneous aortic valve replacement has shown great promise, it still presents challenges in terms of delivery techniques, paravalvular leakage, and valve durability. On the other hand, if the native aortic valve can still be used, only repairing the aortic valve insufficiency rather than replacing it with a prosthetic valve has greater advantages.

Utility model content

In view of this, there is provided an auxiliary occlusion device for aortic valve insufficiency that can assist the closure of the aortic valve during ventricular diastole to prevent the backflow of blood in the aorta into the left ventricle. The specific technical scheme is as follows.

An auxiliary occlusion device for aortic valve insufficiency, the auxiliary occlusion device includes a positioning mechanism and an auxiliary occlusion member disposed at the proximal end of the positioning mechanism, the positioning mechanism is fixed to the main valve in a released state. within the artery so that the auxiliary occluder is located between the aortic valves.

Preferably, the positioning mechanism and the auxiliary blocking member have an integral structure or a fixed connection structure.

Preferably, during ventricular diastole, the aortic valve is attached to the outer surface of the auxiliary occluder, so as to seal the separation between the aorta and the left ventricle, and prevent blood from flowing back into the left ventricle from the aorta.

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.

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

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

Preferably, the connecting piece and the anchoring piece have an integral structure or a fixed connecting structure; or the connecting piece and the auxiliary blocking piece have an integral structure or a fixed connecting structure; or the connecting piece and the anchor The fixed piece and the auxiliary blocking piece have an integral structure or are all fixed connection structures.

Preferably, the anchoring member 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.

Preferably, when the anchor is a self-expanding structure, the anchor includes at least one of an expanded frame structure, a stent-graft or a bare stent, the frame structure including a plurality of angularly spaced and An axially extending support; the covered stent includes a covered film and an annular support frame fixed on the covered film; the bare stent is a braided mesh stent or an integrally cut and formed frame stent.

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

Preferably, the support proximal ends of some of the plurality of support members are gathered and fixed at the first proximal end of the frame structure, and the support proximal ends of another part of the plurality of support members are close to the frame structure. The ends are gathered and fixed at the second proximal end of the frame structure, wherein the first proximal end is disposed closer to the distal end of the frame structure than the second proximal end, wherein another part of the support proximal end in the support member The auxiliary occluder is connected at the second proximal end.

Preferably, a portion of the support proximal end of the support member is connected at the first proximal end with the support proximal end of another portion of the support member at the second proximal end through a first connecting rod.

Preferably, the supporting distal ends of some of the plurality of supporting members are gathered and fixed at the first distal end of the frame structure, and another part of the plurality of supporting members has The supporting distal ends are gathered and fixed at the second distal end of the frame structure, wherein the first distal end is disposed closer to the proximal end of the frame structure than the second distal end.

Preferably, the first distal end of the supporting distal end of a part of the supporting element is connected with the supporting distal end of the other part of the supporting element through a second connecting rod at the second distal end.

Preferably, the support rod in the support member is connected with the support proximal end of the adjacent support member through a third connecting rod.

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

Preferably, in the stent-graft, the annular support frame includes at least one of an annular structure or a helical structure, and the annular structure refers to an annular structure composed of a plurality of first wave units connected end to end ; The helical structure refers to a tubular structure formed by a plurality of second wave units connected end to end and continuously arranged in a spiral.

Preferably, when the anchor is a bare stent, the bare stent includes a regular or irregular braided grid stent or a frame stent that is integrally cut and formed.

Preferably, the anchor includes an expandable frame structure and a stent-graft, the frame structure is fixed inside the stent-graft, and the frame structure is fixed with the annular support frame in the stent-graft connected or fixedly connected with the membrane in the stent-graft.

Preferably, when the anchoring member is a balloon-type expansion structure, the balloon-type expansion structure includes an intima wall and an adventitia wall, and the adventitia wall and the intima wall are sealed and connected to form a lumen A sac, wherein the radius of the intimal wall is smaller than the radius of the adventitial wall.

Preferably, the auxiliary blocking member is one of a cylindrical structure, an elliptical cylindrical structure, a cambered cylindrical structure or a flat spindle structure.

Preferably, the cross-sectional area of the auxiliary occluder is smaller than the flow area through the aortic valve annulus.

Preferably, the auxiliary occluder includes a proximal end portion and a distal end portion, wherein the distal end portion is used for connecting with the positioning mechanism, and the radial radius of the proximal end portion is larger than that of the distal end portion to the radius.

Preferably, at least the outer surface of the auxiliary blocking member is made of impermeable material.

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

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, and the distal ends of the fourth connecting rods are fixedly connected to the The proximal end or the distal end of the anchoring member, the proximal end of the fourth connecting rod is gathered and fixedly connected to the distal end of the auxiliary blocking member.

Preferably, when the distal end of the fourth connecting rod is fixedly connected to the proximal end of the anchoring member, the distal ends of the fourth connecting rod are fixedly connected to the proximal end of the anchoring member in an equidistant distribution.

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

Preferably, the auxiliary blocking device includes a recovery head, the recovery head is disposed at the distal end of the auxiliary blocking device, and the recovery head and the anchoring member are of an integral structure or a fixed connection structure.

Preferably, the recovery head includes a hook body or a noose.

Preferably, when the recovery head is a hook body, the hook body is connected to the distal end of the anchor through a fifth connecting rod or is directly fixed to the distal end of the anchor; When it is a noose, the noose includes a connecting portion and a hook portion, the connecting portion is fixed at the distal end of the anchor, and the hook portion goes from the connecting portion to the distal end of the auxiliary blocking device extend.

Preferably, when the recovery head is a hook body, the hook body is connected with the distal end of the anchoring member through a fifth connecting rod, and the auxiliary blocking member is connected with the fifth connecting rod through a fourth connecting rod rod connection.

Preferably, the connecting portion in the noose is fixed around the distal end of the anchor.

Beneficial effects of the present utility model: The auxiliary blocking device provided by the present utility model can assist the aortic valve to block the pore between the aorta and the left ventricle under the condition of aortic valve insufficiency, so as to reduce or prevent the blood from passing through the aorta. The valve does not backflow, and the secondary occlusion device does not obstruct the flow of blood in the aorta when the ventricle contracts.

Description of drawings

FIG. 1 is a schematic structural diagram of an auxiliary occlusion device for aortic valve insufficiency according to the first embodiment of the present invention.

FIG. 2 is a schematic diagram of applying the auxiliary occlusion device in FIG. 1 to the interventional treatment of aortic valve insufficiency provided by the present invention.

3 is a schematic structural diagram of an auxiliary plugging device provided by the second embodiment of the present invention.

FIG. 4 is a schematic structural diagram of an auxiliary plugging device provided by the third embodiment of the present invention.

FIG. 5 is a schematic structural diagram of an auxiliary plugging device provided by the fourth embodiment of the present invention.

FIG. 6 is a schematic structural diagram of an auxiliary plugging device provided by a fifth embodiment of the present invention.

FIG. 7 is a schematic diagram of applying the auxiliary occlusion device in FIG. 5 in the interventional treatment of aortic valve insufficiency provided by the present invention.

FIG. 8 is a schematic structural diagram of an auxiliary plugging device provided by the sixth embodiment of the present invention.

FIG. 9 is a schematic structural diagram of an auxiliary plugging device provided by the seventh embodiment of the present invention.

FIG. 10 is a schematic structural diagram of an auxiliary plugging device provided by the eighth embodiment of the present invention.

FIG. 11 is a schematic structural diagram of an auxiliary plugging device provided by the ninth embodiment of the present invention.

FIG. 12 is a schematic diagram of applying the auxiliary occlusion device in FIG. 11 in the interventional treatment of aortic valve regurgitation provided by the present invention.

13 is a schematic structural diagram of an auxiliary plugging device provided by the tenth embodiment of the present invention.

Fig. 14 is a schematic diagram of an auxiliary occluder with a circular cross-section provided in the aortic valve provided by the present invention.

FIG. 15 is a schematic diagram of an auxiliary occluder with an oval cross section provided in the aortic valve provided by the present invention.

16 is a schematic structural diagram of an auxiliary plugging device provided by the eleventh embodiment of the present invention.

17 is a schematic structural diagram of an auxiliary plugging device provided by the twelfth embodiment of the present invention.

18 is a schematic structural diagram of an auxiliary plugging device provided by the thirteenth embodiment of the present invention.

FIG. 19 is a schematic structural diagram of an auxiliary plugging device provided by the fourteenth embodiment of the present invention.

Detailed ways

The following description is the preferred embodiment of the present invention. It should be pointed out that for those skilled in the art, without departing from the principle of the present invention, several improvements and modifications can be made. These improvements and modifications It is also regarded as the protection scope of the present invention.

In the description of the present invention, the "proximal end" of the present invention refers to the end close to the left ventricle of the heart, and the "distal end" refers to the end far from the left ventricle of the heart. The axial direction refers to the direction of the central axis of the auxiliary plugging device, and the radial direction is the direction perpendicular to the central axis.

Referring to FIG. 1 , a first embodiment of the present invention provides an auxiliary occlusion device 10 for aortic valve insufficiency. The auxiliary occlusion device 10 includes a positioning mechanism 20 and an auxiliary sealing device disposed at the proximal end of the positioning mechanism 20 . The positioning mechanism 20 is fixed in the aorta in the released state, and is used for positioning the auxiliary occlusion device 10 in the aorta, so that the auxiliary occlusion member 200 is located between the aortic valves. The positioning mechanism 20 and the auxiliary occluding member 200 are integrated or fixedly connected, and the positioning mechanism 20 is a self-expanding structure or a balloon-expanding structure, so that the positioning mechanism 20 can be clamped at the distal end of the aortic valve in the released state on the inner wall of the aorta. During ventricular diastole, the aortic valve is abutted against the outer surface of the auxiliary occluder 200 to seal the separation between the aorta and the left ventricle, preventing the backflow of blood from the aorta into the left ventricle.

In this embodiment, the positioning mechanism 20 includes an anchoring member 100 and a connecting member 300 . The auxiliary blocking member 200 is connected to the proximal end of the anchoring member 100 . Specifically, the auxiliary blocking member 200 is located on the anchoring member 100 through the connecting member 300 . the proximal end. The anchoring member 100 and the auxiliary blocking member 200 are integrally formed or connected by a connecting member 300 . 1 shows that the anchoring member 100 and the auxiliary blocking member 200 are connected by a connecting member 300 , and FIGS. 3 and 4 show an integrated structure of the anchoring member 100 and the auxiliary blocking member 200 . The anchoring member 100 can be snapped on the inner wall of the aorta at the distal end of the aortic valve in the released state, and the auxiliary blocking member 200 can be inserted between the aortic valves and assist in blocking the aortic valve insufficiency during ventricular diastole. porosity.

Please refer to FIG. 2 , the connecting member 300 connects the auxiliary blocking member 200 to the anchoring member 100. Specifically, the connecting member 300 is respectively connected to the anchoring member 100 and the auxiliary blocking member 200 by welding, sewing, etc. Piece 100 is an expandable structure. When the positioning mechanism 20 (anchor 100 ) is placed on the ascending aortic segment D1 , it acts as an anchor relative to the auxiliary occluder 200 . At this time, the auxiliary occluder 200 can be accurately released between the three leaflets of the aortic valve D2, and closely fit with the three leaflets during the dilation of the ventricle, thereby sealing the separation between the aorta and the left ventricle, reducing or avoiding Blood flows back through the aortic valve and can flow through the anchor 100 during ventricular systole.

The auxiliary blocking device 10 for aortic valve closure provided by the present invention can assist the aortic valve to block the pore between the aorta and the left ventricle in the case of aortic valve insufficiency, so as to reduce or prevent blood from passing through the aorta. The arterial valve regurgitates, and the secondary occlusion device 10 does not obstruct the flow of blood in the aorta when the ventricle contracts.

In a further embodiment, the connecting member 300 and the anchoring member 100 have an integral structure or a fixed connecting structure (refer to FIG. 1 , FIG. 16 and FIG. 19 ). Alternatively, the connecting member 300 and the auxiliary blocking member 200 may have an integral structure or a fixed connecting structure (refer to FIG. 17 and FIG. 18 ). Alternatively, the connecting member 300 is an integral structure with the anchoring member 100 and the auxiliary blocking member 200 or both are fixed connecting structures (refer to FIG. 1 ). The connecting member 300 is connected with the anchoring member 100 and the auxiliary blocking member 200 in the above-mentioned various ways, so that the structure of the device 10 provided by the present invention is more diverse, and the device 10 can be more stable. Select to make the application work better.

In a further embodiment, the anchor 100 is a self-expanding structure (see Figures 1, 3 and 5) or a balloon-expanding structure (see Figure 13), so that it can be snapped into place in the released state The location of the inner wall of the aorta distal to the aortic valve. Adopting a self-expanding structure or a balloon-expanding structure makes the anchor 100 in a contracted state before entering the aorta, which facilitates the entry of the entire auxiliary occlusion device 10 into the aorta. When the auxiliary occlusion device 10 enters the aorta, After the artery is properly positioned, eg, above the coronary ostium, the anchor 100 begins to expand, and the anchor 100 can be fixed on the vessel wall above the coronary ostium by the outward self-expanding force of the anchor 100 .

Referring to FIGS. 3 , 5 and 8 , in a further embodiment, when the anchor 100 is a self-expanding structure, the anchor 100 includes an expandable frame structure 400 , a covered stent 500 or a bare stent 600 at least one of them. The frame structure 400 includes a plurality of angularly spaced and axially extending supports 410 (see FIG. 3). The stent graft 500 includes a membrane 510 and an annular support frame 520 fixed on the membrane 510 (refer to FIG. 5 ). The bare stent 600 is a braided mesh stent or an integrally cut and formed frame stent (refer to FIG. 8 ).

Referring to FIG. 3 , a second embodiment of the present invention provides an auxiliary plugging device 10 a . In the auxiliary plugging device 10 a , the anchoring member 100 adopts a frame structure 400 . The support member 410 in the frame structure 400 sequentially includes a support proximal end 411 , a support rod 412 and a support distal end 413 , the support proximal end 411 of the plurality of support members 410 is gathered and fixed at the proximal end of the frame structure 400 , and the plurality of support members 410 The supporting distal ends 413 in the plurality of supporting members 410 are gathered and fixed at the distal end of the frame structure 400, and the supporting rods 412 in all the supporting members 410 are angularly spaced to form an expansion body. That is to say, the frame structure 400 is roughly a structure with two ends small and the middle large, and the expansion 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 Nitinol. After the anchors 100 of the frame structure 400 are delivered to the lumen, the frame structure 400 can be deformed back to a deployed state upon release from the delivery sheath of the delivery device to bring at least a portion of the radial support rods 412 into contact with the inner lumen wall . The expansion body formed by the support rod 412 is cylindrical, and the diameter of the cylindrical expansion body is larger than the diameter of the lumen. It can be understood that the number of the support members 410 can be set according to actual needs, and the angle of the interval between the support rods 412 in the two adjacent support members 410 is determined according to the number of the support members 410. Make the force around the cylindrical expansion body uniform.

The manner in which the supporting proximal end 411 of the supporting member 410 is gathered and fixed may be an integrally formed structure, or may be fixed by the fixing member 414 . Similarly, the manner in which the supporting distal ends 413 of the supporting member 410 are gathered and fixed may be an integrally formed structure, or may be fixed by a fixing member.

Referring to FIG. 4 , a third embodiment of the present invention provides an auxiliary plugging device 10b. In the auxiliary plugging device 10b, the support proximal ends 411 of some of the support members 410 of the plurality of support members 410 are gathered and fixed on the frame. At the first proximal end J1 of the structure 400, the supporting proximal ends 411 of another part of the supporting members 410 in the plurality of supporting members 410 are gathered and fixed at the second proximal end J2 of the frame structure 400, wherein the first proximal end J1 is relatively The two proximal ends J2 are disposed close to the distal end of the frame structure 400 , wherein the supporting proximal end 411 in the other part of the supporting member 410 is connected to the auxiliary blocking member 200 at the second proximal end J2 . In this embodiment, the supporting proximal ends 411 in some of the supporting members 410 are gathered and fixed, and then the supporting proximal ends 411 in another part of the supporting members 410 are gathered and fixed, so as to make the structure of the supporting member 410 more stable.

In a further embodiment, the support proximal end 411 of the partial support member 410 is connected at the first proximal end J1 with the support proximal end 411 of the other partial support member 410 at the second proximal end J2 through the first connecting rod 701 . The supporting proximal ends 411 at the first proximal end J1 and the second proximal end J2 are connected by the first connecting rod 701 , so that the anchor 100 can more easily control the expanded shape during expansion.

In a further embodiment, the supporting distal ends 413 of some of the plurality of supports 410 are gathered and fixed at the first distal end Y1 of the frame structure 400 , and another part of the plurality of supports 410 is fixed in the first distal end Y1 of the frame structure 400 . The supporting distal ends 413 are gathered and fixed at the second distal end Y2 of the frame structure 400, wherein the first distal end Y1 is disposed closer to the proximal end of the frame structure 400 than the second distal end Y2. The supporting distal ends 413 in part of the supporting members 410 are gathered and fixed, and then the supporting distal ends 413 in another part of the supporting members 410 are gathered and fixed, so as to make the structure of the supporting member 410 more stable.

In a further embodiment, the support distal end 413 of the partial support member 410 is connected at the first distal end Y1 with the support distal end 413 of the other partial support member 410 at the second distal end Y2 through the second connecting rod 702 . Connecting the supporting distal ends 413 at the first distal end Y1 and the second distal end Y2 through the second connecting rod 702 makes it easier to control the expanded shape of the anchor 100 during expansion.

In a further embodiment, the support rod 412 in the support member 410 is connected with the support proximal end 411 in the adjacent support member 410 through the third connecting rod 703 . In order to make the anchor 100 of the frame structure 400 more stable.

In a further embodiment, the connection point 414 of the support rod 412 in the support member 410 and the support proximal end 411 is connected with the support proximal end 411 in the adjacent support member 410 through the third connecting rod 703 . In order to further stabilize the anchor 100 of the frame structure 400 .

In some embodiments, in the support member 410 , the support distal end 413 further includes an extension section 415 extending from the distal end of the support distal end 413 to the proximal end, and the extension section 415 is disposed at the support distal end 413 The connection with the support rod 412. When the frame structure 400 of this embodiment is placed in the aorta and self-expanding, the extension section 415 can further support the lumen wall, so that the anchoring member 100 of the frame structure 400 can be more stably anchored in the lumen wall of the aorta .

Please refer to FIG. 5 and FIG. 6 , the fourth embodiment of the present invention provides an auxiliary plugging device 10c and the fifth embodiment provides an auxiliary plugging device 10d. In the stent-graft 500, the annular support frame 520 includes at least one of an annular structure 530 (see FIG. 5 ) or a helical structure 540 (see FIG. 6 ). The annular structure 530 refers to a plurality of first wave units 531 A ring structure formed end to end. The helical structure 540 refers to a tubular structure formed by a plurality of second wave units 541 connected end to end and continuously spirally arranged.

It can be understood that, when only the annular structure 530 is included in the annular support frame 520 , there are multiple annular structures 530 . When the annular support frame 520 has only the helical structure 540, there may be only one helical structure 540, or there may be a plurality of the helical structures 540. It can be understood that the annular support frame 520 may also be composed of the annular structure 530 and the helical structure 540 together.

Referring to FIGS. 5 and 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 during expansion are equal to or different from a first predetermined range. In order to make the support force on the lumen wall of the entire annular support frame 520 after expansion more uniform. It can be understood that the inner diameter of the annular structure 530 in the annular support frame 520 during expansion can also be set according to the inner diameter of the lumen wall, so that the annular support frame 520 is more matched with the lumen wall during expansion, and the fixed is more stable. Stablize.

In a further embodiment, the wavelengths of the first waveform units 531 in each annular structure 530 are the same or different by a second preset range. Wherein, when the wavelengths are equal, the peaks and troughs of the two adjacent annular structures 530 correspond to each other, so as to increase the flexibility and make the annular support frame 520 of the annular structure 530 more compliant with the aorta.

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 anchors 100 of the stent-graft 500 can be anchored in the ascending aortic segment.

In a further embodiment, in the stent graft 500 , the graft 510 is disposed on the inner side and/or the outer side of the annular support frame 520 . The film 510 can 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.

Referring to FIG. 8 to FIG. 10 , in some embodiments, when the anchor 100 is a bare stent 600 , the bare stent 600 includes a regular or irregular woven mesh stent or a frame stent that is integrally cut and formed. The braided grid support is woven from the support bar 610 .

The regular woven mesh scaffold is shown in Figures 8 to 10 . In FIG. 8 , the auxiliary plugging device 10e provided by the sixth embodiment of the present invention is shown with a denser grid structure, and in FIG. 9 , the auxiliary plugging device 10f provided by the seventh embodiment is shown with The grid structure is relatively sparse. In FIG. 10 , the auxiliary plugging device 10g provided by the eighth embodiment is shown as having a support strip-like structure that is perpendicular to each other. By providing these diverse bare stents, the treatment of aortic valve insufficiency in different conditions is more personalized.

It can be understood that when the membrane 510 in the stent-graft 500 is removed, the annular support frame 520 can also be referred to as a bare stent 600, that is to say, the bare stent 600 can also be composed of the annular structure 530 or the helical structure 540. .

In some embodiments, the bare stent 600 may be cylindrical with a radial radius slightly larger than the lumen diameter of the aorta when expanded, so that the anchors 100 of the bare stent 600 may be anchored located in the ascending aorta.

Referring to FIG. 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, and the frame structure 400 is fixed on the covering Inside the stent graft 500 , the frame structure 400 is fixedly connected with the annular support frame 520 in the stent graft 500 or with the membrane 510 in the stent graft 500 . It can be understood that the stent graft 500 in this embodiment can be set longer (refer to FIG. 12 ), so that the stent graft 500 can be extended to the position of the aortic arch D3 to make the anchor 100 more stable in the luminal wall of the immobilized aorta.

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 on the aortic lumen wall close to the aortic valve, so that when the ventricle contracts, when the blood flows into the aorta from the aortic valve and impacts the anchor 100, The support firmness of the anchor 100 on the lumen wall will not be affected.

Referring to FIG. 13 , the tenth embodiment of the present invention provides an auxiliary occlusion device 10i. In the auxiliary occlusion device 10i, the anchoring member 100 is a balloon-type expansion structure 800, and the balloon-type expansion structure 800 includes an intima wall 810 and adventitial wall 820, the adventitial wall 820 and the intimal wall 810 are sealingly connected to form a lumen sac 830, wherein the radius of the intimal wall 810 is smaller than the radius of the adventitial wall 820. A channel T capable of blood circulation is formed in the middle of the intimal wall 510, and the middle lumen balloon 830 expands when the anchor 100 expands to support the lumen wall.

In a further embodiment, the auxiliary blocking member 200 is one of a cylindrical structure, an elliptical cylindrical structure, a cambered cylindrical structure or a flat spindle structure. As shown in FIG. 14 , the cross-section of the cylindrical auxiliary plug 200 is circular. As shown in FIG. 15 , the cross section of the elliptical-cylindrical auxiliary plug 200 is elliptical.

In further embodiments, the cross-sectional area of the auxiliary occluder 200 is less than the flow area through the aortic valve annulus. The auxiliary occluder 200 thus does not substantially obstruct the flow of blood through the aortic valve during ventricular systole.

Referring to FIG. 16 , the eleventh embodiment of the present invention provides an auxiliary plugging device 10j. In the auxiliary plugging device 10j, the auxiliary plugging member 200 includes a proximal end portion 210 and a distal end portion 220, wherein the distal end portion 220 uses a It is connected with the positioning mechanism 20 . Specifically, the distal portion 220 is used for connecting with the anchoring member 100 or the connecting member 300 . An embodiment in which the distal portion 220 is connected to the connector 300 is shown in FIG. 16 . The radial radius of the proximal end portion 210 is greater than the radial radius of the distal end portion 220 . The proximal portion 210 is used to release between the three leaflets of the aortic valve when the ventricle expands, and to produce a tight seal with the three leaflets to reduce or prevent the backflow of blood through the aortic valve.

In a further embodiment, at least the outer surface of the auxiliary occluder 200 is made of an impermeable material. In order to prevent blood from penetrating into the auxiliary blocking member 200 .

In some embodiments, the surface of the secondary occluder 200 is compliant to create a tight seal with the leaflet.

In some embodiments, the surface of the auxiliary occluder 200 includes a biocompatible material to prevent possible abrasion of the leaflet when the surface of the auxiliary occluder 200 is engaged with the leaflet.

In some embodiments, the secondary occluder 200 has a predetermined rigidity to maintain its deployed shape, and a predetermined elasticity and/or flexibility to tightly engage the leaflets.

It can be understood that the auxiliary occluder 200 can be made of high molecular polymer material, metal or other biocompatible materials suitable for implantation into the body.

In a further embodiment, the auxiliary blocking member 200 is a solid structure or a hollow structure, and both ends of the hollow structure are closed structures, so that the fluid cannot pass through the proximal end and the distal end of the auxiliary blocking member 200 . The auxiliary blocking member 200 with a hollow structure is lighter in weight, and is not easy to fall off or slide when placed in the lumen of the aorta.

Referring to FIG. 1 , FIG. 16 , FIG. 17 and FIG. 18 , in some embodiments, the anchoring member 100 and the auxiliary blocking member 200 are connected by a linear connecting member 300 . The connecting member 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 the distal end of the anchoring member 100, and the proximal ends of the fourth connecting rods 310 are gathered and fixedly connected to the auxiliary blocking member 200 far end. In FIGS. 1 and 16 , the distal end of the connecting member 300 is fixedly connected to the proximal end of the anchoring member 100 , and in FIGS. 17 and 18 , the distal end of the fourth connecting rod 310 is fixedly connected to the distal end of the anchoring member 100 . end. In FIG. 18 , in the auxiliary occluder device 101 provided by the thirteenth embodiment of the present invention, the fourth connecting rod 310 is directly connected with the recovery hook 910 at the distal end of the anchor 100 , that is to say, in this embodiment In the example, the auxiliary blocking member 200 and the anchoring member 100 are both connected to the hook body 910. When the auxiliary blocking member 101 is retrieved and taken out, the hook body 910 pulls the auxiliary blocking member 200 and the anchoring member 100 to withdraw quickly.

In a further embodiment, when the distal end of the fourth connecting rod 310 is fixedly connected to the proximal end of the anchor member 100 , the distal ends of the fourth connecting rod 310 are fixedly connected to the proximal end of the anchor member 100 in an equidistant distribution. In order to make the arrangement of the fourth connecting rods 310 in the connecting member 300 more uniform, it is more favorable for the connecting rods 300 to be fixed on the anchoring member 100 .

Referring to FIG. 17 , in the auxiliary occlusion device 10k provided by 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 member 100, the fourth connecting rod 310 can be connected On the retrieval head 900 connected to the distal end of the anchor 100. For example, in FIG. 17 , 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 .

In further embodiments, the connector 300 is made of metal material, polymer material or other biocompatible material. Memory alloys such as Nitinol are preferred.

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

Referring to FIG. 1 again, in a further embodiment, the auxiliary occlusion device 10 includes a recovery head 900 , the recovery head 900 is disposed at the distal end of the auxiliary occlusion device 10 , and the recovery head 900 and the anchor 100 are integrally structured or fixed connection structure. The retrieval head 900 is used to remove the entire device 10 from the aorta, enabling retrieval.

Referring to FIGS. 17 , 18 and 19 , in further embodiments, the retrieval head 900 includes a hook body 910 or a noose 920 . 17 and 18 show an embodiment in which the recovery head 900 adopts the hook body 910 . An embodiment employing a lasso 920 is shown in FIG. 19 .

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

Referring to FIG. 19, in the auxiliary blocking device 10m provided by the fourteenth embodiment of the present invention, when the recovery head 900 is a noose 920, the noose 920 includes a connecting portion 921 and a hook portion 922, and the connecting portion 921 is fixed on the anchor At the distal end of the stator 100 , the hook portion 922 extends from the connecting portion 921 to the distal end of the auxiliary occluding device 10 . In this embodiment, the hook portion 922 in the noose 920 is used to assist the position where the blocking device 10 is hooked by the external device when it is recovered. At the distal end of the anchor 100, when the hook portion 922 is pulled out, the entire device 10 will be pulled out through the connecting portion 921.

In a further embodiment, the connection portion 921 in the noose 920 is secured around the distal end of the anchor 100 . The connecting portion 921 is fixed around the distal end of the anchor member 100 , so that when the noose 920 pulls out the device 10 , the anchor member 100 can be taken out more conveniently and smoothly.

In any of the above embodiments, the anchoring member 100 is made of metal material, polymer material or other biocompatible material with expansion properties and/or elasticity. Preferably, it is made of at least one of stainless steel, titanium, shape memory alloy or other biocompatible metals.

The above-mentioned embodiments only represent several embodiments of the present invention, and the descriptions thereof are specific and detailed, but should not be construed as limiting the scope of the present invention. It should be pointed out that for those of ordinary skill in the art, some modifications and improvements can be made without departing from the concept of the present invention, which all belong to the protection scope of the present invention. Therefore, the protection scope of the patent for this utility model shall be subject to the appended claims.

Claims (33)

1. an auxiliary blocking device for aortic valve insufficiency, characterized in that, the auxiliary blocking device comprises a positioning mechanism and an auxiliary blocking member arranged at the proximal end of the positioning mechanism, and the positioning mechanism is In the released state, it is fixed in the aorta, so that the auxiliary occluder is located between the aortic valves. 2 . The auxiliary plugging device according to claim 1 , wherein the positioning mechanism and the auxiliary plugging member have an integral structure or a fixed connection structure. 3 . 3. The auxiliary occlusion device according to claim 1, wherein during ventricular diastole, the aortic valve is attached to the outer surface of the auxiliary occlusion member, so that the space between the aorta and the left ventricle is closed. The septum is sealed to prevent backflow of blood from the aorta into the left ventricle. 4 . The auxiliary occlusion device according to claim 1 , wherein the positioning mechanism is a self-expanding structure or a balloon-expanding structure, so that it can be clamped at the distal end of the aortic valve in a released state. 5 . on the inner wall of the aorta. 5. The auxiliary occlusion device of claim 1, wherein the positioning mechanism comprises an anchor, and the auxiliary occlusion is connected to a proximal end of the anchor. 6 . The auxiliary occluding device according to claim 5 , wherein the positioning mechanism further comprises a connecting piece connected between the anchoring piece and the auxiliary occluding piece. 7 . 7 . The auxiliary blocking device according to claim 6 , wherein the connecting member and the anchoring member have an integrated structure or a fixed connecting structure; or the connecting member and the auxiliary blocking member are integrated into an integrated structure. 8 . structure or a fixed connection structure; or the connecting piece, the anchor piece and the auxiliary blocking piece have an integral structure or both are fixed connection structures. 8. The auxiliary occlusion device according to claim 5 or 6, wherein the anchoring member is a self-expanding structure or a balloon-expanding structure, so that it can be clamped on the aorta in a released state On the inner wall of the aorta distal to the valve. 9 . The auxiliary occlusion device according to claim 8 , wherein when the anchoring member is a self-expanding structure, the anchoring member comprises an expanded frame structure, a stent-graft or a bare stent. 10 . At least one, the frame structure includes a plurality of angularly spaced and axially extending supports; the covered stent includes a covering and an annular support frame fixed on the covering; the bare stent is a braided mesh stent Or a frame bracket that is cut and formed in one piece. 10 . The auxiliary occlusion device according to claim 9 , wherein the support members in the frame structure sequentially comprise a support proximal end, a support rod, and a support distal end, and the support proximal ends in the plurality of support members. 11 . The proximal end of the frame structure is gathered and fixed, the supporting distal ends of the plurality of supporting members are gathered and fixed at the distal end of the frame structure, and the supporting rods in all the supporting members are arranged at intervals to form an expansion body. 11. The auxiliary occlusion device according to claim 10, wherein the support proximal ends of some of the plurality of support members are gathered and fixed at the first proximal end of the frame structure, and the plurality of support members are fixed at the first proximal end of the frame structure. Another part of the support members has the support proximal ends in the support members gathered and fixed at the second proximal end of the frame structure, wherein the first proximal end is closer to the distal end of the frame structure than the second proximal end An end arrangement, wherein a supporting proximal end of the other portion of the supporting member is connected to the auxiliary occluding member at the second proximal end. 12 . The auxiliary occlusion device according to claim 11 , wherein the support proximal end of part of the support members is at the first proximal end and the support proximal end of another part of the support member is at the first proximal end. 12 . The second proximal end is connected by the first connecting rod. 13. The auxiliary occlusion device according to claim 10, wherein the supporting distal ends of some of the plurality of supporting members are gathered and fixed at the first distal end of the frame structure, and the plurality of supporting members are fixed at the first distal end of the frame structure. The distal ends of the supports in the other part of the supporting members are gathered and fixed at the second distal end of the frame structure, wherein the first distal end is closer to the second distal end than the second distal end. Proximal setting of frame structure. 14 . The auxiliary occlusion device according to claim 13 , wherein the distal end of the support in a part of the support is at the first distal end and the distal end of the support in the other part of the support is at the end of the support 14 . The second distal end is connected by a second connecting rod. 15 . The auxiliary occlusion device according to claim 10 , wherein the support rod in the support piece is connected with the support proximal end of the adjacent support piece through a third connecting rod. 16 . 16. The auxiliary occlusion device according to claim 10, wherein the connection between the support rod in the support member and the support proximal end and the support proximal end in the adjacent support member are connected by a third connecting rod . 17. The auxiliary occlusion device according to claim 9, wherein in the stent-graft, the annular support frame comprises at least one of an annular structure or a helical structure, and the annular structure is Refers to a ring-shaped structure formed by a plurality of first wave units connected end to end; the helical structure refers to a tubular structure formed by a plurality of second wave units connected end to end and continuously spirally arranged. 18. The auxiliary occlusion device according to claim 9, wherein when the anchoring member is a bare stent, the bare stent comprises a regular or irregular braided mesh stent or an integrally cut and formed frame stent . 19. The auxiliary occlusion device according to claim 9, wherein the anchoring member comprises an expandable frame structure and a stent-graft, the frame structure is fixed inside the stent-graft, and the The frame structure is fixedly connected with the annular support frame in the stent-graft or with the membrane in the stent-graft. 20. The auxiliary occlusion device according to claim 8, wherein when the anchoring member is a balloon-type expansion structure, the balloon-type expansion structure comprises an intima wall and an adventitia wall, and the The adventitial wall and the intimal wall are sealingly connected to form a medial sac, wherein the radius of the intimal wall is smaller than the radius of the adventitial wall. 21. The auxiliary plugging device according to claim 1, wherein the auxiliary plugging member is one of a cylindrical structure, an elliptical cylindrical structure, a cambered cylindrical structure or a flat spindle structure. 22. The auxiliary occlusion device of claim 1, wherein the cross-sectional area of the auxiliary occluder is less than the flow area through the aortic valve annulus. 23. The auxiliary occlusion device of claim 1, wherein the auxiliary occlusion member comprises a proximal end portion and a distal end portion, wherein the distal end portion is used to connect with the positioning mechanism, the The radial radius of the proximal end portion is greater than the radial radius of the distal end portion. 24. The auxiliary occlusion device of claim 1, wherein at least an outer surface of the auxiliary occlusion member is made of an impermeable material. 25. The auxiliary plugging device according to claim 1, characterized in that, the auxiliary plugging member is a solid structure or a hollow structure, and both ends of the hollow structure are closed structures, so that the fluid cannot pass through the auxiliary plug. The proximal end of the blocking member communicates with the distal end. 26. The auxiliary plugging device according to claim 6, wherein the anchoring member and the auxiliary plugging member are connected by a linear connecting member; the connecting member comprises a plurality of fourth connecting rods , the distal end of the fourth connecting rod is fixedly connected to the proximal end or the distal end of the anchoring member, and the proximal end of the fourth connecting rod is gathered and fixedly connected to the distal end of the auxiliary blocking member. 27. The auxiliary occlusion device according to claim 26, wherein when the distal end of the fourth connecting rod is fixedly connected to the proximal end of the anchoring member, the distal end of the fourth connecting rod Equidistantly distributed and fixedly attached to the proximal end of the anchor. 28. The auxiliary blocking device according to claim 6, wherein the connecting member is rigid in a released state, so that the anchoring member and the auxiliary blocking member are in a relatively stable fixed position . 29. The auxiliary occlusion device according to claim 5 or 6, wherein the auxiliary occlusion device comprises a recovery head, the recovery head is disposed at the distal end of the auxiliary occlusion device, and the recovery head It has an integral structure or a fixed connection structure with the anchor. 30. The auxiliary occlusion device of claim 29, wherein the retrieval head comprises a hook body or a noose. 31. The auxiliary occlusion device according to claim 30, wherein when the recovery head is a hook body, the hook body is connected to the distal end of the anchoring member through a fifth connecting rod or is directly fixed At the distal end of the anchor; when the retrieval head is a noose, the noose includes a connecting part and a hook, the connecting part is fixed at the distal end of the anchor, and the hook Extends from the connecting portion toward the distal end of the auxiliary occlusion device. 32. The auxiliary occlusion device according to claim 30, wherein when the recovery head is a hook body, the hook body is connected with the distal end of the anchoring member through a fifth connecting rod, and the The auxiliary blocking member is connected with the fifth connecting rod through a fourth connecting rod. 33. The auxiliary occlusion device of claim 31, wherein the connecting portion in the noose is secured around the distal end of the anchor.

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