WO2022141789A1 - Valvule cardiaque - Google Patents

Valvule cardiaque Download PDF

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Publication number
WO2022141789A1
WO2022141789A1 PCT/CN2021/078855 CN2021078855W WO2022141789A1 WO 2022141789 A1 WO2022141789 A1 WO 2022141789A1 CN 2021078855 W CN2021078855 W CN 2021078855W WO 2022141789 A1 WO2022141789 A1 WO 2022141789A1
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WO
WIPO (PCT)
Prior art keywords
sub
support
connecting rods
stent
heart valve
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PCT/CN2021/078855
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English (en)
Chinese (zh)
Inventor
虞奇峰
秦涛
Original Assignee
上海纽脉医疗科技有限公司
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Application filed by 上海纽脉医疗科技有限公司 filed Critical 上海纽脉医疗科技有限公司
Publication of WO2022141789A1 publication Critical patent/WO2022141789A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2421—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with non-pivoting rigid closure members
    • A61F2/2424—Ball valves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body

Definitions

  • the invention relates to the technical field of medical devices, in particular to a heart valve.
  • the heart is divided into two parts, left and right, each of which includes a ventricle and an atrium.
  • the ventricle and the ventricle and between the atrium and the atrium are separated by the interventricular septum and the atrial septum.
  • flow valve the valve between the left atrium and the left ventricle is the mitral valve
  • the valve between the right atrium and the right ventricle is the tricuspid valve
  • the valve between the left ventricle and the aorta is the aortic valve
  • the valve between the right ventricle and the right ventricle is the aortic valve.
  • the valve between the pulmonary arteries is the pulmonary valve.
  • Heart valve refers to the valve between the atrium and the ventricle or between the ventricle and the artery. Valves play a key role in the blood circulation activity of the heart, acting as a one-way valve. The heart valve opens and closes as the heart contracts and relaxes, thereby ensuring unidirectional flow of blood.
  • Heart valve disease is a common heart disease, especially with the aggravation of the aging population, senile heart valve disease and valve disease caused by coronary heart disease and myocardial infarction are becoming more and more common, and it is worth everyone's attention.
  • heart valve disease refers to the disease of the mitral valve, tricuspid valve, aortic valve and pulmonary valve due to various congenital and acquired reasons, resulting in the failure of the valve to fully close or fully open normally, thus affecting blood flow. normal flow, resulting in abnormal cardiac function.
  • the invention proposes a heart valve.
  • the purpose of the present invention is to provide a heart valve, which is used to solve the technical problems that the existing valve is easy to cause outflow tract obstruction, and the large size of the outer stent affects the hemodynamic performance, thereby causing thrombosis or hemolysis.
  • a heart valve that is at least partially degradable.
  • the minimally invasive interventional implantation of the heart valve can be used to treat heart valve diseases.
  • heart valves can be fixed by tight junctions between endothelialized dense and native tissue.
  • a degradable part of the heart valve can be selected according to the actual application scenario, and the size of the part is gradually reduced due to degradation until it disappears completely. In this way, the obstruction of the outflow tract can be effectively reduced, the influence on the hemodynamics can be reduced, and the probability of thrombosis and hemolysis can be avoided.
  • the outer support includes a first sub-support, a second sub-support and a third sub-support for connecting the first sub-support and the second sub-support; wherein , the first sub-stent and/or the second sub-stent can be degraded in whole or in part.
  • the first sub-bracket, the second sub-bracket and the third sub-bracket included in the outer bracket are assembled into one body by splicing, which is beneficial to production and processing and reduces the cost compared with the one-piece structure.
  • the second sub-stent is used to fit the atrial wall, so that when the atrium undergoes dynamic changes, it can ensure that the outer stent will not be detached from the atrial wall, and is used to assist the fixation of the heart valve. This makes it easier for new endothelial cells to grow where the second sub-scaffold is in contact with the atrial wall to form the endothelialized dense.
  • first sub-stent and/or the second sub-stent of the outer stent can be degraded in whole or in part, so, when the heart valve is implanted into the human atrium, with the continuous formation of endothelialized dense matter, and the first sub-stent and/or The second sub-stent is continuously degraded and ablated, and finally the heart valve is fixed by tight junction with the native tissue by the endothelialized dense material.
  • This can effectively reduce the obstruction of the outer stent to the outflow tract, and the degradation of the larger-sized outer stent can effectively avoid the artificial heart valve from changing the cardiac hemodynamics, thereby reducing the probability of thrombosis or hemolysis.
  • the third sub-support is made of a non-degradable metal material; wherein, the material of the third sub-support is at least one of nickel-titanium alloy, stainless steel and cobalt-based alloy; and/or the third sub-support is A sub-stent is made of at least one of magnesium alloy, iron alloy, zinc alloy and polymer degradable material; and/or the second sub-stent is made of magnesium alloy, iron alloy, zinc alloy and polymer degradable material at least one of them.
  • the third sub-stent can be endothelialized through the sealing membrane and the native tissue, and formed into one body
  • the valve leaflet can be effectively fixed; on the other hand, the size of the outer stent can be reduced, which can effectively avoid the change of the heart valve to the heart hemodynamics, thereby reducing the probability of thrombosis or hemolysis.
  • the first sub-support is a V-shaped annular grid composed of a plurality of V-shaped pieces butted end to end; the butt ends of every two adjacent V-shaped pieces are used to connect the third sub-support.
  • a bracket ; the wave crests of the plurality of V-shaped pieces are provided with barbs extending outward, and the barbs are degradable; and/or the butt ends of the plurality of V-shaped pieces are provided with barbs extending outward barbs, the barbs are fixedly connected to the third sub-support, and the barbs are not degradable.
  • the first sub-support is set as a V-shaped annular grid, and this structure is not only conducive to fixing the third sub-support, but also reduces the weight of the first sub-support.
  • the native valve leaflets are hooked, so as to fix the heart valve without causing the heart valve to roll over.
  • the barbs arranged at the peak position of the V-shaped piece are degradable, the barbs arranged on the butt end are not degradable, and the barbs at this position are fixedly connected to the third sub-bracket, which can effectively prevent insufficient endothelialization.
  • the first sub-stent has been completely degraded, which may easily lead to the unstable fixation of the heart valve by the outer stent.
  • the number of the V-shaped pieces included in the V-shaped annular grid is 12-24.
  • the number of V-shaped parts is set within a certain range to ensure the stability of the structure under a certain volume.
  • the third sub-support includes a plurality of main connecting rods and a plurality of leaflet connecting rods; a plurality of the main connecting rods with the same number and spacing are arranged between every two adjacent leaflet connecting rods. connecting rods; one end of the plurality of main connecting rods and the plurality of leaflet connecting rods in the same direction is respectively used to connect the abutting ends of the plurality of V-shaped pieces, and the other ends are respectively used to connect the second sub-bracket.
  • the second sub-support has an everted wave-shaped ring structure; each wave crest of the second sub-support is provided with a second sub-support connector; each of the first sub-supports The butt ends are provided with a first sub-bracket connecting piece; the two ends of each of the main connecting rods and each of the leaflet connecting rods are respectively connected to a second sub-bracket connecting piece and a a first sub-stent connecting member; and each of the main connecting rods and each of the leaflet connecting rods is located inside the second sub-stent connecting member and the first sub-stent connecting member; and/or all
  • the arc-shaped transition at the connection between the second sub-support connector and the second sub-support wave crest; and/or the number of the leaflet connecting rods is three, and is spaced along the circumference of the third sub-support .
  • the lower part of the leaflet connecting rod is used to fix the leaflet, and the upper structure and the main connecting rod together provide radial support force.
  • the second sub-stent is used to fit the atrial wall, so that when the atrium undergoes dynamic changes, it can ensure that the outer stent will not be detached from the atrial wall, and is used to assist the fixation of the heart valve. In this way, new endothelial cells are more likely to grow where the second sub-scaffold is in contact with the atrial wall, and the surface of the second sub-scaffold attached to the atrial wall has a relatively high adhesion rate and is easy to endothelialize.
  • the connection between the second sub-stent connecting piece and the second sub-stent crest is transitioned in an arc shape to fit the contour of the atrial wall and prevent the atrial wall from being squeezed rigidly.
  • one of the plurality of main connecting rods and the plurality of the leaflet connecting rods is a straight rod, and the other one of the plurality of the main connecting rods and the plurality of the leaflet connecting rods is S-shaped.
  • Bending rod; or a part of the plurality of main connecting rods is a straight rod, and another part of the plurality of main connecting rods is an S-shaped curved rod; or a part of the plurality of leaflet connecting rods is a straight rod , the other part of the plurality of leaflet connecting rods is an S-shaped curved rod; and/or one end of the leaflet connecting rods facing the first sub-support is provided with a suture hole; and the suture hole extends to the inner side of the first sub-bracket.
  • the S-shaped curved rod can be used to increase the contact area with the native tissue, which is beneficial to the fixation of the heart valve.
  • the suture hole is arranged to extend to the inner side of the first sub-bracket, in order to prevent the leaflet from being blocked by a plurality of main connecting rods and a plurality of valve leaflet connecting rods during the suture process.
  • it also includes: a first sealing membrane and a valve leaflet; the first sealing membrane covers the inner surface and/or the outer surface of the outer stent; the valve leaflet is arranged on the inner side of the outer stent.
  • it also includes an inner support and a second sealing film; the inner support is arranged on the inner side of the outer support for assembling the valve leaflets; the second sealing film covers the inner support
  • the outer layer is used for connecting the outer support and the inner support.
  • the heart valve in practical application, can be fixed by tight connection between the endothelialized dense substance and the native tissue.
  • a degradable part of the heart valve can be selected according to the actual application scenario, and the part gradually shrinks due to degradation until it disappears completely. In this way, the obstruction of the outflow tract can be effectively reduced, the influence on the hemodynamics can be reduced, and the probability of thrombosis and hemolysis can be avoided.
  • the first sub-stent and/or the second sub-stent can be degraded in whole or in part, and the third sub-stent is not degradable.
  • the outer stent is implanted in the human atrium, With the continuous formation of endothelialized dense substances and the continuous degradation and ablation of the first sub-stent and/or the second sub-stent, the third sub-stent of the heart valve is finally fixed by tight connection with the native tissue by virtue of the endothelialized dense substances. In this way, the volume of the outer stent can be effectively reduced, thereby reducing the obstruction to the outflow channel.
  • the outer stent when the heart valve includes an outer stent and an inner stent, the outer stent can be degraded in whole or in part, and the inner stent cannot be degraded. In this way, the volume of the heart valve can be effectively reduced, the obstruction of the outflow tract by the outer stent can be avoided, and the Effects on hemodynamics thereby avoiding the occurrence of thrombosis and hemolysis.
  • This patent creatively sets the second sub-bracket to fit on the atrial wall, so that when the atrium changes dynamically, it can ensure that the outer bracket will not be separated from the atrial wall, and is used to assist the fixation of the heart valve. This makes it easier for new endothelial cells to grow where the second sub-scaffold is in contact with the atrial wall to form the endothelialized dense.
  • the structure is not only conducive to fixing the third sub-bracket, but also reduces the weight of the first sub-bracket.
  • barbs extending outward are provided on the wave crests and/or butt ends of a plurality of V-shaped pieces to hook the native valve leaflets, thereby fixing the heart valve without causing the heart valve to roll over.
  • the barbs arranged at the peak position of the V-shaped piece are degradable, the barbs arranged on the butt end are not degradable, and the barbs at this position are fixedly connected to the third sub-bracket, which can effectively prevent insufficient endothelialization.
  • the first sub-stent has been completely degraded, which may easily lead to the unstable fixation of the heart valve by the outer stent.
  • This patent sets the number of V-shaped parts within a certain range to ensure the stability of the structure under a certain volume.
  • the V-shaped annular grid is set as one layer, and the length of the outer bracket is reduced by reducing the number of layers of the first sub-bracket, which can further reduce the risk of the outflow channel being blocked.
  • the first sub-bracket, the second sub-bracket and the third sub-bracket of the outer bracket are assembled into one body by splicing, which is beneficial to production and processing and reduces the cost compared with the one-piece structure.
  • connection between the second sub-stent connector and the wave crest of the second sub-stent is set as an arc-shaped transition, which can effectively prevent this part from squeezing the atrial wall rigidly.
  • Fig. 1 is the structural representation of the heart valve of the product of the present invention in one embodiment
  • Fig. 2 is the structural representation of the outer support shown in Fig. 1 in one state;
  • Fig. 3 is an enlarged view of the partial area A shown in Fig. 2;
  • Fig. 4 is an enlarged view of the partial area B shown in Fig. 2;
  • FIG. 5 is a schematic structural diagram of the outer support shown in FIG. 1 in another state
  • FIG. 6 is a schematic diagram of the heart valve shown in FIG. 1 (the first sub-stent and the second sub-stent degraded) after being implanted in the human atrium for a period of time;
  • FIG. 7 is a schematic three-dimensional structure diagram of the heart valve of the product of the present invention in another embodiment
  • FIG. 8 is a schematic structural diagram of the outer support shown in FIG. 7 in one state
  • FIG. 9 is a schematic structural diagram of the outer support shown in FIG. 7 in another state.
  • FIG. 10 is a schematic view of the heart valve shown in FIG. 7 (showing the first sealing membrane) after being implanted in the human atrium for a period of time;
  • FIG. 11 is a schematic diagram of the artificial heart valve shown in FIG. 7 (with the first sealing membrane hidden) implanted in the human atrium for a period of time;
  • FIG. 12 is a schematic diagram of the artificial heart valve shown in FIG. 7 (degradation of the outer stent) after being implanted in the human atrium for a period of time.
  • outer stent 101, blood inflow end; 102, blood outflow end; 110, first sub-support; 111, V-shaped piece; 112, butt end; 113, crest; 114, barb; connector; 120, second sub-stent; 121, wave crest; 122, second sub-stent connector; 130, third sub-stent; 131, main connecting rod; 132, leaflet connecting rod; 1321, suture hole;
  • 200 endothelialized dense substance
  • 300 valve leaflet
  • 410 first sealing membrane
  • 420 second sealing membrane
  • 500 inner stent
  • 600 rivet
  • 700 heart
  • Minimally invasive interventional implantation of heart valves can be used to treat heart valve disease.
  • Existing valve stents as metal parts in direct contact with native tissue, can hinder the free movement of cardiac tissue to a certain extent. For example, if the stent is too long, it will cause outflow tract obstruction and increase the impact of the stent on the hemodynamics of the heart, but if the stent is too short, it will affect the fixation and cause the artificial valve to shift.
  • this patent now provides a heart valve, which is used to solve the technical problems that the existing valve is prone to cause outflow tract obstruction, thrombosis or hemolysis due to the excessive size of the stent.
  • the heart valve provided by this patent can not only ensure effective fixation in the early stage of implantation, but also effectively reduce outflow tract obstruction as the heart valve continues to degrade, reduce the impact on hemodynamics, and avoid the probability of thrombosis and hemolysis.
  • the present invention provides a heart valve that is at least partially degradable.
  • the heart valve in practical application, can be fixed by tight connection between the endothelialized dense substance 200 and the native tissue. Specifically, after the heart valve is implanted into the human atrium, with the continuous formation of the endothelialized dense material 200 , the heart valve is tightly connected and fixed with the native tissue by means of the endothelialized dense material 200 .
  • the larger size of the heart valve can easily lead to the obstruction of the outflow tract. Therefore, making the heart valve degradable can effectively avoid changes to the heart's hemodynamics, thereby reducing the occurrence of thrombosis or hemolysis. The probability.
  • the parts of the degradable stent of the heart valve can be selected according to actual use requirements, the structure of the stent is not limited, and the degradable parts of the stent are also not limited.
  • the site of stent degradation can be regular or irregular, and the specific degradation profile can be specifically set according to the actual situation of the patient. Therefore, any partially degradable or fully degradable heart valve is within the scope of protection of this patent, and the heart valve can be of any type, which will not be repeated here.
  • the heart valve may include a hollow tubular outer stent 100 having a blood inflow end 101 and a blood outflow end 102 .
  • the outer support 100 may include a first sub-support 110 , a second sub-support 120 and a third sub-support 130 for connecting the first sub-support 110 and the second sub-support 120 .
  • the blood inflow end 101 is formed at the port of the second sub-support 120 ; and the blood outflow end 102 is formed at the port of the first sub-support 110 .
  • first sub-bracket 110 , the second sub-bracket 120 and the third sub-bracket 130 of the outer bracket 100 are assembled into one body by splicing, which is beneficial to production and processing and reduces costs compared with the one-piece structure.
  • the first sub-stent 110 is used for fixing with the native valve leaflet, so that the heart valve can be tightly connected and fixed with the native tissue.
  • the second sub-stent 120 is used to fit the atrial wall, so that when the atrium undergoes dynamic changes, it can ensure that the outer stent 100 will not be separated from the atrial wall, so as to assist in the fixation of the heart valve. This makes it easier for new endothelial cells to grow where the second sub-scaffold 120 is in contact with the atrial wall.
  • the first sub-stent 110 and/or the second sub-stent 120 may be degraded in whole or in part, and the third sub-stent 130 is not degradable.
  • the first sub-bracket 110 and the second sub-bracket 120 of the outer stent 100 are both made of degradable metal material, and the third sub-bracket 130 is made of non-degradable metal material.
  • the third sub-bracket 130 of the heart valve relies on Endothelialized dense 200 is fixed in tight junction with the native tissue. In this way, the volume of the outer stent 100 can be effectively reduced, thereby reducing the obstruction to the outflow channel.
  • one of the first sub-support 110 and the second sub-support 120 is made of a degradable metal material, and the other is made of a non-degradable metal material.
  • a part of the first sub-support 110 can also be made of a degradable metal material, and the other part of the first sub-support 110 can also be made of a non-degradable metal material.
  • a part of the second sub-support 120 is made of a degradable metal material, and the other part is made of a non-degradable metal material, which is all possible, and no limitation is made here.
  • the first sub-support 110 and the second sub-support 120 can be preferably made of at least one of the above, but It is not limited to this.
  • the third sub-support 130 can be preferably made by at least one of the above, of course, other non-degradable metal materials can also be used to make the third sub-support 130, without any restriction here.
  • the material of the first sub-support 110 and the second sub-support 120 may not be limited to metal, and may also be made of polymer degradable materials.
  • the biopolymer-based degradable material has the advantages of large deformation range, large adjustment of deformation temperature, good biocompatibility, small difference between mechanical strength and body, not easy to cause body necrosis under pressure, and capable of self-degradation and metabolism in patients.
  • the polymer degradable material can be preferably made of biopolymer degradable materials, but it is not limited to this, and can be selected according to the actual scene. It can be seen from this that any polymer degradable material that can be used for the treatment of heart valve diseases is within the protection scope of this patent, and will not be repeated here.
  • the heart valve further includes a first sealing membrane 410 and valve leaflets 300 .
  • the third sub-stent 130 can be endothelialized through the first sealing membrane 410 and the native tissue, and formed into one body . In this way, on the one hand, the heart valve can be effectively fixed; on the other hand, the size of the outer stent 100 can be reduced.
  • the first sealing membrane 410 can cover the inner surface and/or the outer surface of the outer stent 100, the leaflets 300 are disposed on the inner side of the outer stent 100, can be endothelialized through the first sealing membrane 410 and the native tissue, and formed on the inner surface of the outer stent 100. In one piece, it can effectively fix the heart valve.
  • the outer stent 100 has a hollow tubular structure to form a flow channel for blood to flow. 2
  • the blood inflow end 101 is formed at the port of the second sub-support 120; and the blood outflow end 102 is formed at the port of the first sub-support 110. In this way, during the contraction or relaxation of the heart 700 , blood flows in from the blood inflow end 101 and flows out from the blood outflow end 102 .
  • the first sub-support 110 may be a V-shaped annular grid formed by butting a plurality of V-shaped members 111 end to end. The butt ends 112 of every two adjacent V-shaped pieces 111 are used for connecting the third sub-brackets 130 .
  • the first sub-support 110 is set as a V-shaped annular grid, which is beneficial to fix the third sub-support 130 and reduces the weight of the first sub-support 110 and the burden on the atrium.
  • the V-shaped annular grid can be integrally formed, of course, it can also be formed by welding a plurality of V-shaped parts 111 end to end, which is not limited to this.
  • the number of V-shaped elements 111 included in the V-shaped annular grid may be 12-24, and in this embodiment, it is preferably 24.
  • there may also be 12, 15 or 18, which is not limited thereto.
  • the butt ends 112 of the plurality of V-shaped pieces 111 may be provided with barbs 114 extending outward, the barbs 114 are fixedly connected to the third sub-support 130 , and the barbs 114 Not degradable.
  • each butt end 112 may be provided with a barb 114, which can effectively prevent the first sub-stent 110 from being completely degraded when the heart valve and the native tissue are not fully endothelialized, which may easily cause the outer stent 100 to affect the heart valve.
  • the fixation is not firm. Therefore, adding barbs 114 at the connection between the first sub-stent 110 and the third sub-stent 130 can make the barbs 114 continue to fix the heart valve even if the first sub-stent 110 has been completely degraded.
  • the crests 113 of the plurality of V-shaped pieces 111 may also be provided with barbs 114 extending outward, and the barbs 114 may be degraded.
  • the heart valve is fixed at the initial stage of implantation, and the barbs 114 and the first sub-stent 110 can be degraded together with the gradual formation of the endothelialized dense substance 200 .
  • each crest 113 of the V-shaped member 111 is connected with barbs 114 extending outward, so that the barbs 114 can be evenly distributed on the blood outflow end 102 for hooking The original valve leaflets are hung, and then used to fix the heart valve.
  • a barb 114 can also be connected to the crests 113 of the two V-shaped pieces 111, so that the cost can be saved without reducing the fastening of the barbs 114. sex.
  • the V-shaped annular grid is set as one layer, and the length of the outer stent 100 is reduced by reducing the number of layers of the first sub-support 110 , which can further reduce the risk of the outflow channel being blocked.
  • the first sub-support 110 includes multiple V-shaped annular meshes.
  • the multi-layer V-shaped annular grids are superimposed along their respective axial directions to form a network tube-like structure. In this way, the extension length of the first sub-stent 110 becomes longer, which in turn causes the length of the outer stent 100 to become longer.
  • the outer stent 100 occupies an excessively large area of the ventricle and blocks the area of the outflow tract, which is easy to cause Obstruction of blood outflow tract.
  • the extension length of the first sub-stent 110 should be controlled within a certain range.
  • the first sub-stent 110 can be specifically limited according to the actual heart structure, that is, the V-shaped annular grid is set to be It is not limited to one layer, but can be multi-layered, as long as the extension length of the first sub-stent 110 is suitable for the heart structure, it is not limited to this.
  • the third sub-bracket 130 may include a plurality of main connecting rods 131 and a plurality of leaflet connecting rods 132 that are arranged in parallel with each other. Between every two adjacent leaflet connecting rods 132 are a plurality of main connecting rods 131 with the same number and spacing. One ends of the plurality of main connecting rods 131 and the plurality of leaflet connecting rods 132 in the same direction are respectively used for connecting the butt ends 112 of the plurality of V-shaped pieces 111 , and the other ends are respectively used for connecting the second sub-brackets 120 .
  • the materials of the plurality of main connecting rods 131 and the plurality of leaflet connecting rods 132 may be the same or different, which are not limited herein.
  • the final heart valve relies on the endothelialized dense material 200 is tightly attached to the native tissue for fixation.
  • the plurality of main connecting rods 131 and the plurality of leaflet connecting rods 132 are closely located in the endothelialized dense 200 and the native tissue, and due to the release between the plurality of main connecting rods 131 and the plurality of leaflet connecting rods 132 Therefore, in the process of contraction or relaxation of the heart 700, the plurality of main connecting rods 131 and the plurality of leaflet connecting rods 132 can synchronously contract or relax with the heart 700, thereby improving the application effect thereof.
  • the sum of the number of the plurality of main connecting rods 131 and the plurality of leaflet connecting rods 132 is equal to the number of the V-shaped pieces 111 included in the first sub-support 110 , which is also 12-24, so , the stability of the structure between the first sub-support 110 and the third sub-support 130 can be improved.
  • the number of the V-shaped pieces 111 can also be twice or three times the sum of the number of the main connecting rods 131 and the leaflet connecting rods 132, and the specific number of rods used can be determined according to the actual application scenario. The selection and adjustment are not specified here.
  • the smaller the number of poles the softer the outer bracket 100 and the smaller the supporting force. Therefore, it is necessary to design the number of poles within a reasonable range, so as to ensure the overall support force of the outer stent 100, and at the same time not to damage the native valve annulus tissue due to excessive force.
  • the number of leaflet connecting rods 132 is three, and the peripheral sides of the third sub-brackets 130 are arranged at intervals. In this way, the three leaflet connecting rods 132 can be evenly distributed along the circumferential direction of the third sub-stent 130 by 120° to provide radial support force together with the main connecting rod 131 .
  • the number of leaflet connecting rods 132 is not limited to three, and can be any desired number.
  • one of the plurality of main connecting rods 131 and the plurality of leaflet connecting rods 132 is a straight rod
  • the other one of the plurality of main connecting rods 131 and the plurality of leaflet connecting rods 132 is a straight rod It is an S-shaped bent rod.
  • the plurality of main connecting rods 131 are straight rods
  • the plurality of leaflet connecting rods 132 are all S-shaped curved rods.
  • the plurality of leaflet connecting rods 132 are all set as S-shaped curved rods, which can be used to increase the contact area with the native tissue, which is beneficial to the fixation of the heart valve.
  • the plurality of main connecting rods 131 may also be S-shaped curved rods
  • the plurality of leaflet connecting rods 132 may be straight rods, which can also achieve the same effect as the above, and will not be repeated here.
  • a part of the plurality of main connecting rods 131 is a straight rod, and another part of the plurality of main connecting rods 131 is an S-shaped bent rod. That is, the plurality of main connecting rods 131 can be composed of a plurality of straight rods and a plurality of S-shaped curved rods, and can also be used to strengthen the fixation of the artificial heart valve.
  • a part of the multiple leaflet connecting rods 132 may also be a straight rod, and another part of the multiple leaflet connecting rods 132 may be an S-shaped curved rod. That is, the plurality of leaflet connecting rods 132 can be composed of a plurality of straight rods and a plurality of S-shaped curved rods, and can also be used to strengthen the fixation of the artificial heart valve.
  • the second sub-stent 120 has an everted wavy ring structure, that is, the second sub-stent 120 faces the plurality of main connecting rods 131 and the plurality of leaflet connecting rods 132 .
  • the outer side is rolled to form an included angle of 100-150 degrees with the plurality of main connecting rods 131 and the plurality of leaflet connecting rods 132 .
  • the second sub-stent 120 is used to fit the atrial wall and fix the outer stent 100, so as to ensure that the outer stent 100 will not be detached from the atrial wall when the atrium changes dynamically, and is used to assist the fixation of the heart valve .
  • new endothelial cells are more likely to grow where the second sub-scaffold 120 is in contact with the atrial wall, and the surface of the second sub-scaffold 120 attached to the atrial wall has a relatively high cell adhesion rate and is easy to endothelialize.
  • an included angle of 120 degrees can be formed between the second sub-stent 120 and the plurality of main connecting rods 131 and the plurality of leaflet connecting rods 132, so that the second sub-stent 120 can form an angle of 120 degrees.
  • a plurality of main connecting rods 131 in order to effectively strengthen the fixation between the main connecting rod 131 and the leaflet connecting rod 132 and the second sub-bracket 120 and the first sub-bracket 110 , a plurality of main connecting rods 131.
  • the multiple leaflet connecting rods 132, the multiple V-shaped pieces 111 and the second sub-bracket 120 can be fixed by welding or riveting.
  • a second sub-bracket connecting member 122 may be provided on each wave crest 121 of the second sub-bracket 120 , and correspondingly, each butt end 112 of the first sub-bracket 110 may be provided with a second sub-bracket connector 122 .
  • a first sub-bracket connecting member 115 is provided.
  • the plurality of second sub-bracket connecting members 122 and the plurality of first sub-bracket connecting members 115 are arranged in a one-to-one correspondence with each other. Both ends of each main connecting rod 131 and each leaflet connecting rod 132 are respectively connected to a second sub-stent connecting member 122 and a first sub-stent connecting member 115 in opposite positions.
  • the main connecting rod 13 and the leaflet connecting rod 132 can be fixed to the second sub-stent connecting member 122 and the first sub-stent connecting member 115 by rivets 600, and of course, they can also be fixed by welding, which is not limited thereto.
  • each main connecting rod 131 and each leaflet connecting rod 132 are located inside the second sub-stent connecting member 122 and the first sub-stent connecting member 115 . That is, the main connecting rod 131 and the leaflet connecting rod 132 are located at one end of the main connecting rod 131 and the leaflet connecting rod 132 facing the inner side of the outer stent 100 . In this way, the rigid compression of the atrial wall by the main connecting rod 131 and the leaflet connecting rod 132 can be largely avoided.
  • the arc-shaped transition at the connection between the second sub-stent connector 122 and the wave crest 121 of the second sub-stent 120 can effectively prevent this part from being hard pressed against the atrial wall, so as to ensure that the external The stent 100 is better suited for the human heart 700 .
  • each leaflet connecting rod 132 facing the first sub-bracket 110 that is, the end for connecting the V-shaped piece 111 is provided with a suture hole 1321 , for suturing the leaflets 300.
  • the suture hole 1321 can be set to extend to the inner side of the first sub-stent 110, that is, It is the inner side of the V-shaped annular mesh, which can facilitate the suturing of the leaflets 300.
  • a connecting head (not shown) can be detachably assembled at one end of each leaflet connecting rod 132 facing the first sub-bracket 110 , and one, two or even multiple suture holes can be opened on the connecting head. 1321, for suturing the leaflets 300.
  • the connecting head can be fixed to the leaflet connecting rod 132 by screwing, but it is not limited thereto.
  • valve leaflet 300 provided in this embodiment can be a tricuspid valve.
  • the three suture holes 1321 corresponding to the three valve leaflet connecting rods 132 correspond to the three arc edges of the tricuspid valve, respectively. This facilitates the suture fixation of the valve leaflets 300 .
  • the valve leaflet 300 may also be a bi-leaflet valve or other number of valve leaflets, which is not limited thereto.
  • the valve leaflet 300 is made of biological tissue, such as bovine pericardium or pig pericardium.
  • the valve leaflet 300 can also be a valve made of a polymer material or a tissue engineered valve.
  • the first sealing film 410 provided in this embodiment may be made of a polymer material, such as PTE, etc., but is not limited thereto.
  • the first sub-stent 110 and/or the second sub-stent 120 are continuously degraded and ablated, and the third sub-stent 130 can pass through
  • the first sealing membrane 410 and the native tissue are endothelialized and formed into one body.
  • the heart valve can be effectively fixed; on the other hand, the size of the outer stent 100 can be reduced, the outflow tract obstruction can be effectively reduced, and the impact on hemodynamics can be reduced to avoid the probability of thrombosis and hemolysis.
  • this embodiment further includes an inner support 500 and a second sealing film 420 .
  • the inner stent 500 is disposed on the inner side of the outer stent 100' for assembling the valve leaflets 300.
  • the second sealing film 420 covers the outer layer of the inner stent 500 for connecting the outer stent 100' and the inner stent 500.
  • the second sealing film 420 connects the outer bracket 100' and the inner bracket 500 to realize the fixation of the inner bracket 500.
  • the structure of the outer bracket 100 ′ is compared with that of the outer bracket 100 in the above-mentioned embodiments, except that the outer bracket 100 ′ does not have the suture hole 1321 and the first sub bracket 110 ′ included in the outer bracket 100 ′ of this embodiment Except that the second sub-support 120' and the third sub-support 130' are made of degradable metal materials, the rest of the structure is the same as that of the outer support 100 in the above-mentioned embodiment.
  • a description of the structure of the outer stent 100 is compared with that of the outer bracket 100 in the above-mentioned embodiments, except that the outer bracket 100 ′ does not have the suture hole 1321 and the first sub bracket 110 ′ included in the outer bracket 100 ′ of this embodiment Except that the second sub-support 120' and the third sub-support 130' are made of degradable metal materials, the rest of the structure is the same as that of the outer support 100 in the above-mentioned embodiment.
  • a description of the structure of the outer stent 100 is
  • the inner stent 500 provided in this embodiment is made of a non-degradable metal material.
  • a suture hole (not shown) may be added to the inner stent 500 to suture the valve leaflets 300 .
  • the specific opening position of the suture hole can be specifically set according to the actual application scenario, and will not be repeated here.
  • the artificial heart valve provided in this embodiment is implanted into the heart 700 for a period of time, with the passage of the implantation time, because the second sealing membrane 420 seals the inner stent 500 and the outer stent 100 ′, the inner stent 500 and the outer stent 100 ′ are sealed with the blood.
  • the continuous deposition between the outer stents 100' and the endothelialization of the second sealing membrane 420 and the native tissue will form an endothelialized dense 200 between the inner stents 500 and the outer stents 100'.
  • the heart valve is finally fixed by the endothelialized dense material 200 and the native tissue in close connection.
  • the obstruction of the outflow tract by the outer stent 100' can be effectively reduced, and the degradation of the larger-sized outer stent 100' can effectively prevent the heart valve from changing the hemodynamics of the heart 700, thereby reducing the probability of thrombosis or hemolysis.
  • the first sub-support 110', the second sub-support 120' and the third sub-support 130' can be fixed by welding or riveting.
  • it can be riveted, wherein the material of the rivet 600 should also be made of a degradable metal material, so as to be degraded and ablated together with the first sub-support 110 ′, the second sub-support 120 ′ and the third sub-support 130 ′ , to avoid residues.

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  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

Une valvule cardiaque au moins partiellement dégradable, la conception de la valvule cardiaque la rendant au moins partiellement dégradable, une partie dégradable de la valvule cardiaque peut être sélectionnée selon le scénario d'application réel, et la taille de la partie est progressivement réduite jusqu'à ce qu'elle soit complètement dégradée et disparaisse. Dans des applications pratiques, une valvule cardiaque peut être étroitement reliée et fixée au moyen d'une densité endothélialisée et d'un tissu primaire. De cette manière, l'obstruction du conduit de sortie peut être efficacement réduite, et l'influence sur l'hémodynamique est réduite, de telle sorte que la probabilité d'apparition de thrombus et d'hémolyse est évitée.
PCT/CN2021/078855 2020-12-29 2021-03-03 Valvule cardiaque WO2022141789A1 (fr)

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CN202011605401.1 2020-12-29
CN202011605401.1A CN114681133A (zh) 2020-12-29 2020-12-29 心脏瓣膜

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