Left atrial appendage occluder

Abstract

An improved left atrial appendage (LAA) occluder is provided. The improved LAA occluder includes a sealing disc and an anchoring device, both of which are mutually connected, At least two flow blocking membranes are arranged in the sealing disc. A part, cooperating with an LAA, of the anchoring device is an anchoring net, and the anchoring net is of a backboneless structure. The whole anchoring device is of the backboneless structure. The anchoring device is formed by weaving metal wires, a distal end of the anchoring device is opened, a proximal end of the anchoring device is constricted and is connected with the sealing disc to form a conical net, the distal end of the anchoring device is opened and is rolled towards the proximal end to form the anchoring net, and the anchoring net surrounds the conical net.

Claims

1. An improved left atrial appendage (LAA) occluder, comprising a sealing disc and an anchoring device, both of which are mutually connected; the sealing disc comprising: a disc surface provided with a first fixed end for connecting a transport device; and a waist part extending from the disc surface, wherein the waist part is provided with: a second fixed end connected to the anchoring device; a diffusion section radiated outwards from the second fixed end; and a body section extending between an outer periphery of the disc surface and an outer periphery of the diffusion section, wherein the body section has a top edge extending radially outward to directly connect with the outer periphery of the disc surface, and a bottom edge connected with the outer periphery of the diffusion section; wherein the disc surface, the body section, and the diffusion section cooperate to define a cylindrical cavity within the waist part; wherein at least two flow blocking membranes are arranged in the sealing disc, wherein one of the at least two flow blocking membranes is sutured in the disc surface and perpendicular to an axis of the LAA occluder extending from the first fixed end to the second fixed end, and the other one of the at least two flow blocking membranes is sutured to the waist part and received in the cavity, and perpendicular to the axis of the LAA occluder, wherein the disc surface is configured to be positioned at an opening of an LAA and completely occlude, through the flow blocking membrane sutured in the disc surface, the opening of the LAA to prevent blood from flowing into the LAA; wherein the waist part is configured to be received in a passage portion of the LAA communicating with the opening, to contact an inner wall of the passage portion, wherein the waist part is configured to further occlude, through the flow blocking membrane sutured within the cavity of the waist part, the passage portion of the LAA to further prevent blood from flowing into the LAA.

2. The improved LAA occluder according to claim 1, wherein the bottom edge of the body section and the outer periphery of the diffusion section are in arc transition.

3. The improved LAA occluder according to claim 2, wherein the other one of the at least two flow blocking membranes is located in the body section or on the diffusion section of the waist part.

4. The improved LAA occluder according to claim 2, wherein the at least two flow blocking membranes comprise three flow blocking membranes, one flow blocking membrane is arranged in the disc surface, one flow blocking membrane is located in the body section of the waist part, and one flow blocking membrane is located on the diffusion section.

5. The improved LAA occluder according to claim 1, wherein a part of the anchoring device cooperating with the LAA is an anchoring net, and the anchoring net is a backboneless structure.

6. The improved LAA occluder according to claim 5, wherein the anchoring device has a structure rolled from interior to exterior, an inner edge part of the rolled structure is connected with the sealing disc, and a periphery part of the rolled structure is the anchoring net that is configured to cooperate with the LAA.

7. The improved LAA occluder according to claim 6, wherein the anchoring device comprises a first end portion, a second end portion and a body between the first end portion and the second end portion, wherein the first end portion is gathered together and welded to form a center end, the body extends outwards from the first end portion to form a conical net, and then gradually reverses outwards and extends towards the first end portion to form the anchoring net surrounding the conical net, wherein the anchoring net defines a first opening at the second end portion, and the center end extends out of the first opening to connect with the second fixed end of the sealing disc; wherein the anchoring device is configured to be released in the LAA, and the anchoring net is configured to cooperate with an inner wall of the LAA, and the anchoring net is of a backboneless structure; wherein the sealing disc is configured to be released in a second opening of the LAA to occlude the second opening.

8. The improved LAA occluder according to claim 7, wherein the body extends outwards from the first end portion to form the conical net, then gradually reverses outwards to form an arc transition area, and then extends towards the first end portion to form the anchoring net surrounding the conical net, wherein the arc transition area is connected between the conical net and the anchoring net.

9. The improved LAA occluder according to claim 8, wherein the anchoring net is provided with multiple barbs, and when the anchoring net is in a tension compression state along the axis of the LAA occluder, the barbs are arranged on the inner side surface of the anchoring net.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) FIG. 1 is an integral schematic diagram of an LAA occluder in embodiment 1.

(2) FIG. 2 is a schematic diagram of a sealing disc of the LAA occluder in embodiment 1.

(3) FIG. 3a is a schematic diagram of an anchoring device of the LAA occluder in embodiment 1.

(4) FIG. 3b is a schematic diagram of an anchoring device of the LAA occluder in embodiment 1 (from another perspective).

(5) FIG. 4 is a schematic diagram of a steel bushing for connecting the sealing disc with the anchoring device in embodiment 1.

(6) FIG. 5 is a structural schematic diagram of a nickel-titanium wire for weaving a frame of the anchoring device in embodiment 1.

(7) FIG. 6a is a schematic diagram of a connection between a nickel-titanium wire as a barb and the nickel-titanium wire for weaving the frame of the anchoring device in embodiment 1.

(8) FIG. 6b is an enlarged diagram of part A in FIG. 6a.

(9) FIG. 7a is a schematic diagram of a net tube that is woven in an anchoring device manufacturing process in embodiment 1.

(10) FIG. 7b is an enlarged diagram of part B in FIG. 7a.

(11) FIG. 8 is a schematic diagram of the woven net tube after its one end is constricted and welded in embodiment 1.

(12) FIG. 9 is a schematic diagram of a center end of the anchoring device without welding a steel bushing in embodiment 1.

(13) FIG. 10 is a schematic diagram of the LAA occluder released in the LAA in embodiment 1.

(14) FIG. 11a is a schematic diagram illustrating a connection between a nickel-titanium wire as a barb and a nickel-titanium wire for weaving a frame of an anchoring device in embodiment 2.

(15) FIG. 11b is an enlarged diagram of part C in FIG. 11a.

(16) FIG. 12a is a schematic diagram of an LAA occluder in embodiment 2.

(17) FIG. 12b is an enlarged diagram of part D in FIG. 12a.

(18) FIG. 13a is a schematic diagram of a connection between a nickel-titanium wire used as a barb and a nickel-titanium wire for weaving a frame of an anchoring device in embodiment 3.

(19) FIG. 13b is an enlarged diagram of part E in FIG. 13a.

(20) FIG. 14a is a schematic diagram of an LAA occluder in embodiment 3.

(21) FIG. 14b is an enlarged diagram of part F in FIG. 14a.

(22) FIG. 15a is a schematic diagram of an anchoring device in embodiment 4.

(23) FIG. 15b is a schematic diagram of an anchoring device in embodiment 4 (from another perspective).

(24) FIG. 16a is a schematic diagram of an anchoring device in embodiment 5.

(25) FIG. 16b is a schematic diagram of an anchoring device in embodiment 5 (from another perspective).

(26) FIG. 17a is a schematic diagram of an anchoring device in embodiment 6.

(27) FIG. 17b is a schematic diagram of an anchoring device in embodiment 6 (from another perspective).

(28) FIG. 18 is a schematic diagram of a sealing disc in embodiment 7.

(29) FIG. 19 is an integral schematic diagram of an LAA occluder in embodiment 7.

(30) FIG. 20 is a schematic diagram of the LAA occluder released in the LAA in embodiment 7.

(31) FIG. 21a is a schematic diagram of the anchoring net prepared to be released in embodiment 1.

(32) FIG. 21b is a schematic diagram of a constricted area of the anchoring net to be released in embodiment 1.

(33) FIG. 21c is a schematic diagram of the anchoring device after the releasing is completed in embodiment 1.

(34) FIG. 22a is a schematic diagram of the anchoring device prepared to be withdrawn after the withdrawing of the sealing disc is completed in embodiment 1.

(35) FIG. 22b is a schematic diagram of the anchoring device that is partially withdrawn in embodiment 1.

(36) FIG. 22c is a schematic diagram of barbs that are completely withdrawn from the LAA wall in an anchoring device withdrawing process in embodiment 1.

DESCRIPTION OF THE EMBODIMENTS

(37) The present disclosure is described in detail below in conjunction with accompanying drawings and embodiments.

Embodiment 1

(38) As illustrated in FIG. 1, a left atrial appendage (LAA) occluder 100 provided by the present disclosure includes a sealing disc 110 and an anchoring device 120. The anchoring device 120 is of a structure rolled from interior to exterior, an inner edge part of the rolled structure is connected with the sealing disc 110, and a periphery part of the rolled structure is an anchoring net 122 that cooperates with an LAA and is of a backboneless structure.

(39) The sealing disc 110 is of a net-shaped structure formed by weaving nickel-titanium wires. As illustrated in FIG. 2, the sealing disc 110 includes a disc surface 111 and a waist part 112. A first fixed end 113 is arranged at the center of the disc surface 111, and a second fixed end 114 is arranged at the center of the waist part 112. One layer of PET flow blocking membrane 115 is sutured in the disc surface 111 perpendicular to an axis X-X of the LAA occluder, and one layer of flow blocking membrane 116 is sutured in the waist part 112 perpendicular to the axis of the ocluder X-X.

(40) The first fixed end 113 is used for connecting a transport device, and the second fixed end 114 is connected with the anchoring device 120.

(41) As illustrated in FIG. 2, the waist part 112 includes a diffusion section 117 that is radiated outwards from the second fixed end 114, and a body section 118 that is cylindrical and is located on the periphery of the diffusion section 117. The body section 118 has a top edge connected with the disc surface 111, and a bottom edge in transition connection with the outer edge of the diffusion section 117 through a circular arc 119, and the flow blocking membrane 116 in the waist part 112 is located at the axial middle part of the body section 118.

(42) The diffusion section 117 is radiated and diffused outwards from the second fixed end 114 so as to form a plane, and the second fixed end 114 is formed slightly near the disc surface 111 so as to form a sunken area in the plane.

(43) As illustrated in FIG. 3a and FIG. 3b, the anchoring device 120 is formed by weaving nickel-titanium wires, and the anchoring net 122 cooperating with the inner wall of the LAA is in the shape of a nest (namely bowl-shaped). The anchoring device 120 is of a backboneless structure, that is, no framework is arranged in the anchoring device 120 for supporting.

(44) In the embodiment, the anchoring device 120 is of a bi-layer structure. The middle part of the anchoring device 120 is constricted and extends towards the sealing disc 110 so as to form an inner-layer conical net 121. The proximal end of the conical net 121 is constricted and then is connected with the center end 126 of the sealing disc 110, and the anchoring net 122 is located on the periphery of the conical net 121. In the embodiment, the anchoring net 122 surrounds a part, near the proximal end, of the conical net 121 in a rolling manner, and is connected with the bottom edge of the conical net through an arc transition area 124. Six barbs 127 are uniformly distributed on the outer surface of the nest-shaped anchoring net 122.

(45) The opening of the nest is bent inwards to form a constricted area 123 (that is, one end, near the sealing disc 110, of the nest-shaped anchoring net 122 radially extends towards the center end 126 so as to form the constricted area 123). The center end 126 is located at an axial end of the conical net 121, and the constricted area 123 and the nest-shaped anchoring net 122 are in smooth transition connection through an arc transition area 125.

(46) As illustrated in FIG. 4, the second fixed end 114 of the sealing disc 110 and the center end 126 of the anchoring device 120 are welded together with each other through a steel bushing 130 so as to form the LAA occluder 100 illustrated in FIG. 1.

(47) In the embodiment, the anchoring device 120 is formed by weaving 24 nickel-titanium wires, where six nickel-titanium wires are used for forming the barbs, and the residual 18 nickel-titanium wires are used for weaving a frame of the anchoring device, and the diameter of the nickel-titanium wires for forming the barbs and the diameter of the nickel-titanium wires for forming the frame are same.

(48) As illustrated in FIG. 5, the nickel-titanium wires for weaving the frame of the anchoring device are pre-molded into a reversed V shape, and there are totally 18 reversed V-shaped nickel-titanium wires. As illustrated in FIG. 6a and FIG. 6b, each nickel-titanium wire 1221 for forming the barb and one side 1222 of one reversed V-shaped nickel-titanium wire for weaving the frame of the anchoring device are in parallel arrangement (both of which can be fixed or not fixed according to requirements during parallel arrangement), and they are pressed and fixed by a steel bushing (made of a stainless steel material) 1223. The steel ferrule 1223 is formed near an apex 1224, at which two sides of the reversed V-shaped nickel-titanium wire are intersected.

(49) As shown in FIG. 6b, an end part 1225, extending from the steel bushing 1223, of the nickel-titanium wire 1221 forms a barb 127, the length of the end part 1225 is 2 mm (namely H1=2 mm illustrated in FIG. 6b), and a distance between the end point 1226 of the end part 1225 and the apex 1224 of the reversed V-shaped nickel-titanium wire is 8 mm.

(50) After the nickel-titanium wires are prepared, all nickel-titanium wires are firstly woven and shaped to form a straight cylindrical net tube 101. As illustrated in FIG. 7a and FIG. 7b, the six nickel-titanium wires for forming the barbs are uniformly distributed along the circumference of the net tube 101. After the net tube 101 is manufactured, as illustrated in FIG. 8, first, the tail end 1011 of the net tube 101 can be fixed and welded by utilizing a stainless steel bushing, then the net tube 101 is formed into the shape of an anchoring device illustrated in FIG. 3 through molds and high-temperature heating, and meanwhile, the end part 1225 is partially expanded outward for at a certain angle (such as 30 degrees) to form the barb 127.

(51) As illustrated in FIG. 1, in the embodiment, the barbs 127 are uniformly distributed along the circumference of the anchoring net, radially and externally rolled along the anchoring net 122, and axially inclined along the anchoring net 122. More intuitively, as illustrated in FIG. 7a and FIG. 7b, in an anchoring device 120 manufacturing process, the nickel-titanium wires for forming the barbs 127 and the nickel-titanium wires for forming the frame of the anchoring device are arranged in parallel, and the tail ends of the nickel-titanium wires for forming the barbs 127 are tilted up, so that an angle (which is not zero) is formed between each nickel-titanium wire for forming the barb 127 and each nickel-titanium wire for forming the frame of the anchoring device as illustrated in FIG. 3a.

(52) In the embodiment, the diameter of the nickel-titanium wires for forming the barbs may be larger than that of the nickel-titanium wires for forming the frame of the anchoring device. The number of the barbs on the anchoring net may be 3, 9 or other numbers in a uniform distribution manner, and the frame of the anchoring device may be woven by using 36 or other numbers of the reversed V-shaped nickel-titanium wires.

(53) In the embodiment, the steel bushings 1223 for fixing the barbs 127 and the steel bushing for anchoring the tail end 1011 of the net tube 101 may be made from nickel-titanium or other metals meeting the biocompatibility requirements.

(54) In the embodiment, after the manufacturing of the net tube 101 woven by the nickel-titanium wires is completed, the net tube 101 can be first formed into a shape illustrated in FIG. 9, and then the center end is welded and fixed by the metal bushing to form a shape illustrated in FIG. 3.

(55) In the embodiment, the LAA occluder 100 can be enclosed in a transport device with a small diameter (such as an inner diameter of 9 F), then sequentially enter superior vena cava by virtue of femoral vein puncture, the right atrium, and the left atrium by virtue of interatrial septal puncture. When the LAA occluder 100 is released, first, the anchoring device 120 is released in the LAA, and the barbs 127 on the anchoring net 122 hook the inner wall of the LAA. Then the waist part 112 of the sealing disc 110 is released at the opening of the LAA, and the disc surface 111 of the sealing disc 110 is released at the opening of the left atrium, thereby sealing the opening of the LAA. After the releasing is completed, the LAA occluder is removed from a connection part with the transport device. FIG. 10 is a schematic diagram illustrating the finally released LAA occluder. In FIG. 10, a represents the left atrium, b represents the LAA, c represents the left ventricle, d represents the right ventricle, and e represents the right atrium.

(56) In the embodiment, the anchoring device 120 of the LAA occluder 100 is in a uniform mesh shape woven by the nickel-titanium wires, and the nest-shaped anchoring net 122 on the outer layer of the anchoring device 120 can uniformly come into contact with the inner wall of the LAA to ensure that the pressure is uniformly applied to the inner wall of the LAA and no local stress concentration occurs.

(57) In the embodiment, the barbs 127 on the anchoring net 122 of the LAA occluder 100 are made from the nickel-titanium wires, and the diameter of each barb 127 is relatively smaller, so that the perforation of the inner wall of the LAA is not easy to occur.

(58) In the embodiment, the sealing disc 110 of the LAA occluder 100 has the waist part 112 and the disc surface 111 at the same time, and both of the waist part 112 and the disc surface 111 can achieve a function of occluding the opening of the LAA. Therefore, such double occlusion effect improves the integral occlusion function of the LAA occluder 100.

(59) In the embodiment, the LAA occluder 100 can be repeatedly released, and the releasing process is illustrated in FIG. 21a, FIG. 21b and FIG. 21c. In the transport device, the anchoring device is in a compression state. When the transport device moves to the opening of the LAA, the anchoring device is gradually released from the transport device. Due to the fact that the anchoring device is made from super elastic metal wires or shape memory alloy wires, after the constricted area on the outer layer of the anchoring net is separated from the transport device, the constricted area automatically rolls outwards, so that a contact part with the LAA wall always is a smooth surface. After the releasing of the anchoring device is completed, the barbs penetrate into the LAA wall, and the penetration directions of the barbs face the opening of the LAA.

(60) If the releasing position of the LAA occluder is improper and the LAA occluder cannot achieve a great sealing effect, the LAA occluder needs to be withdrawn, and the withdrawing process is illustrated in FIG. 22a, FIG. 22b and FIG. 22c. In the LAA occluder withdrawing process, the barbs are completely drawn out of the inner wall of the LAA opposite to the penetration directions, and then are accommodated in the transport device with the outer-layer anchoring net under the traction of the transport device.

(61) As illustrated in FIG. 21a to FIG. 22c, b represents the LAA.

Embodiment 2

(62) The difference between the embodiment 2 and the embodiment 1 is that each nickel-titanium wire 2221 for forming a barb and one reversed V-shaped nickel-titanium wire 2222 for forming a frame of an anchoring net are connected by welding. The length of a welded area 2223 is 2 mm, and the welded area 2223 is adjacent to an apex 2224, at which two sides of the reversed V-shaped nickel-titanium wire are intersected. An end part 2225, extending from the welded area 2223, of the nickel-titanium wire 2221 forms a barb 227, the length of the end part 2225 is 2 mm (namely H2=2 mm in FIG. 11b), and a distance between an end point 2226 of the end part 2225 and the apex 2224 of the reversed V-shaped nickel-titanium wire is 8 mm, as illustrated in FIG. 11a, FIG. 11b, FIG. 12a and FIG. 12b.

Embodiment 3

(63) The embodiment 3 differs from the embodiment 1 in that: the total length of each nickel-titanium wire 3221 for forming a barb is 5 mm, and the nickel-titanium wire 3221 is divided into a fixed section and a free section. The fixed section is connected with the nickel-titanium wire 3222 for forming a frame of an anchoring net through a steel bushing 3223, the length of the fixed section is 3 mm, and the fixed section is completely inside the steel bushing 3223. The free section 3225 extends out of the steel bushing 3223 to form a barb 327, the length of the free section 3225 is 2 mm (namely, in FIG. 13b, H3=2 mm), and a distance between an end point 3226 of the free section 3225 and an apex 3224 of the reversed V-shaped nickel-titanium wire is 8 mm, as illustrated in FIG. 13a, FIG. 13b, FIG. 14a and FIG. 14b.

Embodiment 4

(64) The embodiment 4 differs from the embodiment 1 in that: an anchoring device 420 does not include a constricted area, and only includes a center end 426 connected with a sealing disc, a conical net 421 diffused from the center end 426 to a direction away from the sealing disc, and a nest-shaped anchoring net 422 located on the periphery of the conical net 421. The conical net 421 and the nest-shaped anchoring net 422 are smoothly connected through an arc transition area 424, and six barbs 427 are uniformly distributed on the surface of the nest-shaped anchoring net 422, as illustrated in FIG. 15a and FIG. 15b.

Embodiment 5

(65) In this embodiment, an anchoring device 520 includes a center end 526 connected with a sealing disc, a conical net 521 diffused from the center end 526 to a direction away from the sealing disc, and a truncated-cone-shaped anchoring net 522 located on the periphery of the conical net 521. The conical net 521 and the truncated-cone-shaped anchoring net 522 are smoothly connected through an arc transition area 524, and six barbs 527 are uniformly distributed on the surface of the truncated-cone-shaped anchoring net 522.

(66) The center end 526 is located at an axial end part of the conical net 521. One end, near the sealing disc, of the truncated-cone-shaped anchoring net 522 is connected with a constricted area 523 radially extending towards the center end 526, and the constricted area 523 and the truncated-cone-shaped anchoring net 522 are in smooth transition connection through an arc transition area 525.

(67) The difference between the embodiment 5 and the embodiment 1 is: the structure of the outer-layer anchoring net of the anchoring device 520 is truncated-cone-shaped, as illustrated in FIG. 16a and FIG. 16b.

Embodiment 6

(68) In this embodiment, an anchoring device 620 includes a center end 626 connected with a sealing disc, a conical net 621 diffused from the center end 626 to a direction away from the sealing disc, and a curved ring-shaped anchoring net 622 located on the periphery of the conical net 621. The conical net 621 and the curved ring-shaped anchoring net 622 are smoothly connected through an arc transition area 624, and six barbs 627 are uniformly distributed on the surface of the curved ring-shaped anchoring net 622.

(69) The center end 626 is located at an axial end part of the conical net 621, one end, near the sealing disc, of the curved ring-shaped anchoring net 622 is connected with a constricted area 623 radially extending towards the center end 626, and the constricted area 623 and the curved ring-shaped anchoring net 622 are in smooth transition connection through an arc transition area 625.

(70) The difference between the embodiment 6 and the embodiment 1 is: the structure of the outer-layer anchoring net of the anchoring device 620 is curved ring-shaped, as illustrated in FIG. 17a and FIG. 17b.

Embodiment 7

(71) The difference between the embodiment 7 and the embodiment 1 is: a sealing disc 710 only includes a disc surface 711. A first fixed end 713 and a second fixed end 714 are respectively arranged on the two sides of the disc surface 711, and one layer of PET flow blocking membrane 715 is sutured in the disc surface 711, as illustrated in FIG. 18.

(72) The second fixed end 714 of the disc surface 711 is connected with a center end of an anchoring net 720 through a steel bushing, as illustrated in FIG. 19.

(73) FIG. 20 is a schematic diagram illustrating an LAA occluder 700 provided by this embodiment released in an LAA. In FIG. 20, a represents the left atrium, b represents the LAA, c represents the left ventricle, d represents the right ventricle, and e represents the right atrium.

Embodiment 8

(74) The difference between the embodiment 8 and the embodiment 1 is: three PET flow blocking membranes are arranged in the sealing disc. One flow blocking membrane is sutured in the disc surface, one flow blocking membrane is sutured in the axial middle part of the body section of the waist part, and the last one flow blocking membrane is sutured on the diffusion section.