CN109984868B - Heart valve prosthesis and delivery device - Google Patents
Heart valve prosthesis and delivery device Download PDFInfo
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- CN109984868B CN109984868B CN201711487720.5A CN201711487720A CN109984868B CN 109984868 B CN109984868 B CN 109984868B CN 201711487720 A CN201711487720 A CN 201711487720A CN 109984868 B CN109984868 B CN 109984868B
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- support
- heart valve
- valve prosthesis
- annular
- stent
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- 210000003709 heart valve Anatomy 0.000 title claims abstract description 64
- 229910001285 shape-memory alloy Inorganic materials 0.000 claims description 11
- 230000007306 turnover Effects 0.000 claims description 9
- 239000011800 void material Substances 0.000 claims description 4
- 230000007547 defect Effects 0.000 claims description 3
- 230000000149 penetrating effect Effects 0.000 claims description 2
- 238000010276 construction Methods 0.000 claims 1
- 238000002513 implantation Methods 0.000 description 8
- 239000000956 alloy Substances 0.000 description 7
- 210000001765 aortic valve Anatomy 0.000 description 7
- 229910001000 nickel titanium Inorganic materials 0.000 description 6
- 206010002906 aortic stenosis Diseases 0.000 description 5
- 229910045601 alloy Inorganic materials 0.000 description 4
- 239000002861 polymer material Substances 0.000 description 4
- 229910000838 Al alloy Inorganic materials 0.000 description 3
- 208000003017 Aortic Valve Stenosis Diseases 0.000 description 3
- 229910000570 Cupronickel Inorganic materials 0.000 description 3
- 229910000640 Fe alloy Inorganic materials 0.000 description 3
- 229910001297 Zn alloy Inorganic materials 0.000 description 3
- JRBRVDCKNXZZGH-UHFFFAOYSA-N alumane;copper Chemical compound [AlH3].[Cu] JRBRVDCKNXZZGH-UHFFFAOYSA-N 0.000 description 3
- YOCUPQPZWBBYIX-UHFFFAOYSA-N copper nickel Chemical compound [Ni].[Cu] YOCUPQPZWBBYIX-UHFFFAOYSA-N 0.000 description 3
- TVZPLCNGKSPOJA-UHFFFAOYSA-N copper zinc Chemical compound [Cu].[Zn] TVZPLCNGKSPOJA-UHFFFAOYSA-N 0.000 description 3
- 210000003748 coronary sinus Anatomy 0.000 description 3
- 238000005520 cutting process Methods 0.000 description 3
- 238000001125 extrusion Methods 0.000 description 3
- 238000004519 manufacturing process Methods 0.000 description 3
- 230000006386 memory function Effects 0.000 description 3
- 230000000694 effects Effects 0.000 description 2
- 210000001105 femoral artery Anatomy 0.000 description 2
- 238000010438 heat treatment Methods 0.000 description 2
- 239000005457 ice water Substances 0.000 description 2
- 238000000338 in vitro Methods 0.000 description 2
- 238000007493 shaping process Methods 0.000 description 2
- 206010002383 Angina Pectoris Diseases 0.000 description 1
- 206010050559 Aortic valve calcification Diseases 0.000 description 1
- 206010010356 Congenital anomaly Diseases 0.000 description 1
- 208000000059 Dyspnea Diseases 0.000 description 1
- 206010013975 Dyspnoeas Diseases 0.000 description 1
- 206010042434 Sudden death Diseases 0.000 description 1
- 208000003443 Unconsciousness Diseases 0.000 description 1
- HZEWFHLRYVTOIW-UHFFFAOYSA-N [Ti].[Ni] Chemical compound [Ti].[Ni] HZEWFHLRYVTOIW-UHFFFAOYSA-N 0.000 description 1
- 230000005856 abnormality Effects 0.000 description 1
- 210000000709 aorta Anatomy 0.000 description 1
- 230000004323 axial length Effects 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- 238000009954 braiding Methods 0.000 description 1
- 208000002173 dizziness Diseases 0.000 description 1
- 230000010354 integration Effects 0.000 description 1
- 230000003902 lesion Effects 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 238000000034 method Methods 0.000 description 1
- 230000005012 migration Effects 0.000 description 1
- 238000013508 migration Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000035790 physiological processes and functions Effects 0.000 description 1
- 230000008569 process Effects 0.000 description 1
- 201000003068 rheumatic fever Diseases 0.000 description 1
- 238000009958 sewing Methods 0.000 description 1
- 208000024891 symptom Diseases 0.000 description 1
- 206010042772 syncope Diseases 0.000 description 1
- 230000001225 therapeutic effect Effects 0.000 description 1
- 230000002792 vascular Effects 0.000 description 1
- 238000003466 welding Methods 0.000 description 1
Classifications
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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
-
- 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
- A61F2/2412—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 soft flexible valve members, e.g. tissue valves shaped like natural valves
- A61F2/2418—Scaffolds therefor, e.g. support stents
-
- 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
- A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
-
- 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
- A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
- A61F2/2466—Delivery devices therefor
Landscapes
- Health & Medical Sciences (AREA)
- Cardiology (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Transplantation (AREA)
- Oral & Maxillofacial 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
The invention relates to the technical field of medical equipment, in particular to an expandable annular bracket which can comprise: a prosthetic valve disposed on the annular support; an expandable support structure coupled to the toroidal support and expanding as the toroidal support expands and contracting as the toroidal support contracts; wherein the support structure is configured to provide a support force to the ring support in a radial direction of the ring support when the ring support is in an expanded state. The heart valve prosthesis can effectively improve the supporting force of the whole heart valve prosthesis by providing the annular support with the additional supporting force along the radial direction through the supporting structure, so that the support can be used for effectively expanding calcified plaques at the positions of the primary valve leaflet and the valve leaflet or the valve annulus, and then the effective opening of the artificial valve can be maintained.
Description
Technical Field
The invention relates to the technical field of medical appliances, in particular to a heart valve prosthesis and a conveyor.
Background
The main causes of aortic valve stenosis are mainly sequelae of rheumatic fever, congenital aortic valve structural abnormality or senile aortic valve calcification, etc., which can cause patients to have uncomfortable symptoms such as dyspnea, angina pectoris, dizziness or syncope, etc., and severe aortic valve stenosis can even cause sudden death of patients.
At present, a transcatheter aortic valve replacement (TRANSCATHETER AORTIC VALVE IMPLANTATION, TAVI for short) is generally used for treating aortic valve stenosis, i.e., a valved prosthesis is placed at the aortic root through a catheter delivery system to prop open calcified plaque at the native valve leaflet and leaflet or annulus with the prosthesis so that the artificial valve leaflet works in place of the native leaflet.
However, the insufficient support force of the current valve prosthesis can lead to smaller effective opening area of the valve, so that the curative effect cannot reach the expected value; especially for patients with severe aortic stenosis, it may not even be possible to effectively prop open calcified plaque due to limited stent support. Therefore, how to raise the supporting force of the bracket has become a problem to be solved in the industry.
Disclosure of Invention
In view of the above, it is necessary to provide a heart valve prosthesis and a conveyor that improve the therapeutic effect of aortic stenosis by increasing the supporting force of the stent.
A heart valve prosthesis may include:
An expandable annular stent;
A prosthetic valve disposed on the annular support;
An expandable support structure coupled to the toroidal support and expanding as the toroidal support expands and contracting as the toroidal support contracts; wherein the support structure is configured to provide a support force to the ring support in a radial direction of the ring support when the ring support is in a deployed state.
In an alternative embodiment, the annular stent is a stent made of a shape memory alloy.
In an alternative embodiment, the annular stent is a mesh structure having an upper end and a lower end opposite the upper end, the prosthetic valve includes interconnected leaflets and a skirt disposed at the lower end, and the support structure is disposed at the upper end.
In an alternative embodiment, the support structure is located one fifth to one half of the ring support from the opening at the upper end and the skirt is located one sixth to one third of the ring support from the opening at the lower end.
In an alternative embodiment, the supporting structure comprises a sleeve and a plurality of supporting rods, the sleeve and the annular support are coaxially arranged, and two ends of each supporting rod are respectively connected with the sleeve and the annular support;
wherein the plurality of support rods are uniformly distributed along the circumferential direction of the annular bracket and are used for providing balanced support force along the radial direction for the annular bracket; .
In an alternative embodiment, the plurality of support rods and the annular support are integrally formed by cutting the same pipe.
In an alternative embodiment, the support bar comprises a fixing part, a turnover part and a support part which are connected in sequence;
The fixing part is used for being fixed on the sleeve, the supporting part is used for being connected with the annular bracket, and the turnover part is used for keeping a supporting angle between the fixing part and the supporting part.
In an alternative embodiment, the support angle may range from 60 ° to 120 ° when the ring support is in the expanded state.
In an alternative embodiment, the support angle is 90 °.
In an alternative embodiment, the support angle is 180 ° when the toroidal support is in the contracted state.
In an alternative embodiment, a plurality of strip-shaped grooves are formed on the outer surface of the sleeve;
The extending direction of the strip-shaped groove is parallel to the axial direction of the sleeve, and the fixing parts of the support rods are embedded and fixed in the strip-shaped groove in a one-to-one correspondence mode.
In an alternative embodiment, the sleeve is a hollow post structure; a plurality of first through holes are formed in the strip-shaped groove along the axial direction of the sleeve; a plurality of second through holes are formed in the fixing part corresponding to the first through holes;
the fixing part is fixed in the strip-shaped groove by sequentially penetrating the first through hole and the second through hole corresponding to the first through hole through the suture line.
In an alternative embodiment, the above-described heart valve prosthesis may further comprise:
The hangers are uniformly and fixedly arranged at the opening of the upper end of the annular bracket along the circumferential direction and are used for loading the heart valve prosthesis.
In an alternative embodiment, the lower end of the annular support is provided with a gap, and the gap is a partial grid defect formed in the circumferential direction of the annular support along the axial direction of the annular support from the opening of the lower end of the annular support.
In an alternative embodiment, the number of said voids is one, two or more; a conveyor may include:
the device comprises a conical head, a sheath tube, an inner core, a fixed head, an inner tube and a control handle;
the distal end of the inner tube is connected with the fixed head into a whole, and the proximal end is connected with the control handle;
The inner core is positioned in the inner tube, the distal end of the inner core penetrates through the fixing head to be connected with the conical head, and the proximal end of the inner core is connected with the control handle;
The inner tube is positioned in the sheath tube, and an annular chamber is arranged between the sheath tube and the inner tube and is used for accommodating the heart valve prosthesis in any one of the above-mentioned contracted states; and another annular chamber is arranged between the inner tube and the inner core and is used for accommodating the supporting structure in a contracted state.
In an alternative embodiment, the cone head is in contact with the sheath for preventing the sheath from puncturing the vessel wall.
In an alternative embodiment, the surface of the conical head is coated with a polymer material, and the conical head is woven from a shape memory alloy material.
In an alternative embodiment, the above-mentioned delivery device further comprises a horn section, wherein a proximal end of the horn section is integrally connected with the sheath, and a distal end of the horn section is in contact with the conical head, and the horn section is used for preventing the sheath from stabbing the vessel wall.
In an alternative embodiment, the flare is flared in its contracted state and is hollow cylindrical in the same diameter as the sheath in its expanded state.
In an alternative embodiment, the surface of the horn section is coated with a polymer material, and the horn section is woven from a shape memory alloy material.
In an alternative embodiment, the fixing head is of a tubular structure, and the surface of the fixing head is provided with a groove which can be matched with the hanging lug.
Drawings
FIG. 1 is a schematic illustration of the structure of a heart valve prosthesis according to one embodiment;
FIG. 2 is a schematic view of the support structure shown in FIG. 1;
FIG. 3 is a schematic illustration of the connection between the support rod and the sleeve in the contracted state;
FIG. 4 is a side view of the ring support shown in FIG. 1;
FIG. 5 is a perspective view of the ring support shown in FIG. 1;
FIG. 6 is a schematic view of a conveyor in a contracted state in one embodiment;
fig. 7 is a schematic view of a conveyor in a contracted state in another embodiment.
Detailed Description
The present invention will be described in further detail with reference to the drawings and examples, in order to make the objects, technical solutions and advantages of the present invention more apparent. It should be understood that the specific embodiments described herein are for purposes of illustration only and are not intended to limit the scope of the invention.
Fig. 1 is a schematic structural view of a heart valve prosthesis according to one embodiment. As shown in fig. 1, a heart valve prosthesis may include an expandable ring stent 100, a prosthetic valve 101, and an expandable support structure 10; the ring-shaped support 100 may have a diamond-shaped mesh structure made of a shape memory alloy such as nickel-titanium alloy, so that the ring-shaped support 100 is constrained by an external force to shrink, and when the external force is removed, the ring-shaped support 100 gradually expands to its original shape. A prosthetic valve 101 is provided on the annular stent 100 for achieving a corresponding physiological function in place of the native leaflets when the annular stent 100 is utilized to distract calcified plaque such as the native leaflets and leaflets or annulus; the support structure 10 is connected to the annular stent 100 and expands as the annular stent 100 expands and contracts as the annular stent contracts for providing additional support force to the annular stent 100 in a radial direction of the annular stent 100 when the annular stent 100 is in a deployed state, thereby effectively lifting the support force of the entire heart valve prosthesis 101, so that the annular stent 100 can effectively prop open the native leaflets and calcified plaque at the leaflets or annulus, and can also effectively maintain the opening size of the prosthetic valve 101 afterwards.
Specifically, the ring stent 100 has an upper end 201 and a lower end 202 opposite the upper end 201, blood flowing into the heart valve prosthesis through the lower end 202 and out through the upper end 201. The support structure 10 is arranged at the upper end 201, preferably at one fifth to one half of the ring support 100 at the opening from the upper end 201; the prosthetic valve 101 comprises at least three leaflets (e.g., three leaflets) interconnected, and a skirt 103, the skirt 103 being disposed at the lower end 202, preferably one-sixth to one-third of the annular stent 100 at an opening from the lower end, and one end of each leaflet (not shown) being connected to the skirt and the other end of the leaflet being secured to the annular stent 100 with a connecting structure such as a sewing ring 102. At the same time, a plurality of lugs 104 are also arranged at the opening of the upper end 201 of the annular support 100, and the lugs 104 are uniformly distributed along the circumferential direction of the annular support 100 so as to facilitate the loading and implantation of the heart valve prosthesis.
Fig. 2 is a schematic view of the support structure of fig. 1 in an expanded state. In an alternative embodiment, as shown in fig. 2, the support structure 10 may include a sleeve 110 and a plurality of support rods 105, where the sleeve 110 is disposed coaxially with the toroidal support 100, and one end of each support rod 105 may be connected to the sleeve 110, and the other end may be connected to a support node 109 (as shown in fig. 4) of the toroidal support 100, and the support node 109 is an intersection point of two adjacent diamond-shaped meshes on the toroidal support 100; wherein, the plurality of support rods 105 are uniformly or non-uniformly distributed along the circumferential direction of the sleeve 110, so as to provide a supporting force along the radial direction of the annular support 100 to the annular support 100 by taking the sleeve 110 as a fulcrum when the annular support 100 is in the unfolded state.
Fig. 3 is a schematic view of the support rod in a contracted state. As shown in fig. 2 to 3, the support rod 105 may be constructed using a shape memory alloy such as nickel-titanium alloy, copper-nickel alloy, copper-aluminum alloy, copper-zinc alloy, iron alloy, etc., so that the support rod 105 can have a shape memory function and thus be compatible with the collapsible toroidal support 100. That is, when the toroidal support 100 is in the contracted state, the support rods 105 can remain parallel to the axial direction of the sleeve 110 (as shown in fig. 3, 6) to facilitate loading of the heart valve prosthesis; when the annular support 100 is in the unfolded state, the support rod 105 can restore the preset bent shape due to the alloy with the shape memory function adopted by the support rod 105, so that a preset included angle (as shown in fig. 2 and 4) is formed between the support rod 105 and the sleeve 110 and between the support rod and the annular support 100, and the radial supporting force of the annular support 100 is further improved.
In addition, in order to improve the integration performance of the heart valve prosthesis and reduce the difficulty and the manufacturing cost of the manufacturing process, the annular support 100 and the support rod 105 can be manufactured by adopting the same pipe, namely, the annular support 100 and the support rod 105 are of an integrally formed structure, for example, a nickel titanium pipe with the outer diameter of 5-15 mm can be adopted, the shaped diameter size is cut and selected according to actual requirements, and then the heat treatment shaping is carried out to form the annular support (in an unfolding state) with the diameter of 20-40 mm, for example, the support can be folded inwards to form the support rod 105 through cutting, heat treatment shaping and the like. Of course, the ring support 100 and the support bar 105 may be two separate components and connected together by a rotatable connection structure, such as by welding.
Meanwhile, when the toroidal support 100 is in the unfolded state, a preset included angle between the support bar 105 and the toroidal support 100 is in the range of 60 ° to 120 °, for example 60 °,80 °, 100 ° or 120 °, etc., to ensure that the support bar 105 can provide sufficient radial supporting force to the toroidal support 100; in order to allow the support bar 105 to provide the greatest support force to the toroidal support 100, the support bar 105 may be kept perpendicular to the outer contour of the toroidal support 100 when the toroidal support 100 is in the unfolded state, i.e. the support bar 105 has an angle of 90 ° with the toroidal support 100; the preset included angle between the support rod 105 and the sleeve 110 is also in the range of 60 ° to 120 °, such as 60 °, 70 °, 90 °, 110 ° or 120 °, etc., to ensure that the support rod 105 can obtain a radial supporting force of the sleeve 110; in order to provide the greatest support force to the toroidal support 100 by the support rods 105, the support rods 105 may be perpendicular to the outer contour of the sleeve 110 when the toroidal support 100 is in the unfolded state, i.e. the support rods 105 have an angle of 90 ° with the sleeve 110.
In an alternative embodiment, as shown in fig. 2-3, each support bar 105 may include a fixed portion 105A, a turnover portion 105B, and a support portion 105C connected in sequence; the fixing portion 105A may be used to fix to the sleeve 110, the turnover portion 105B may be used to maintain a supporting angle between the fixing portion 105A and the supporting portion 105C when the toroidal support 100 is in the unfolded state, and the supporting portion 105C may be used to connect with the toroidal support 100 to provide a radial supporting force to the toroidal support 100.
Wherein, the turnover part 105B can be a structure prepared by adopting shape memory alloy such as nickel-titanium alloy, namely, the turnover part 105B has shape memory function to keep a straight shape (as shown in figures 3 and 6) when the annular bracket 100 is in a contracted state so as to facilitate the loading of the heart valve prosthesis; when the toroidal support 100 is in the unfolded state, the folded portion 105B can restore the folded shape, so that a preset supporting angle (as shown in fig. 2 and 4) is formed between the supporting portion 105C and the fixing portion 105A, so that the supporting portion 105C can provide a supporting force along the radial direction of the toroidal support 100 to the toroidal support 100 with the sleeve 110 as a fulcrum.
In addition, the preset supporting angle has a value ranging from 60 ° to 120 °, for example, 60 °, 75 °, 90 °, 105 °, or 120 °, etc., so as to ensure that the supporting portion 105C can obtain a sufficient supporting force along the radial direction of the sleeve 110; in order to maximize the support force provided by the support bar 105 to the toroidal support 100, the support portion 105C may be perpendicular to the fixing portion 105A when the toroidal support 100 is in the unfolded state, i.e. the support angle between the support portion 105C and the fixing portion 105A is 90 °.
In another alternative embodiment, as shown in fig. 2 to 3, a plurality of strip-shaped grooves 111 are formed on the outer surface of the sleeve 110, and the extending direction of each strip-shaped groove 111 is parallel to the axial direction of the sleeve 100, and the fixing portions 105A are embedded and fixed in the strip-shaped grooves in a one-to-one correspondence manner, so that each support rod 105 is fixedly connected with the sleeve 110; in addition, in order to enhance the fixing effect, the shape of the bar-shaped groove is matched with the shape of the fixing portion 105A, so that the fixing portion 105A can be more firmly fixed in the corresponding bar-shaped groove 111. The axial length of the sleeve 110 may be 5-10 mm, the length of the fixing portion 105A may be 3-5 mm, and the length of the turnover portion 105B may be 1-3 mm.
In another alternative embodiment, as shown in fig. 2 to 3, the sleeve 110 may be a hollow column structure (i.e., a hollow cylindrical structure), and a plurality of first through holes (not shown) are formed in the bar-shaped groove 111 along the axial direction of the sleeve 110, and a plurality of second through holes 112 are also formed in the fixing portion 105A corresponding to the first through holes, so as to sequentially pass through the first through holes and the second through holes 112 overlapped with the first through holes by using a connection structure such as a suture line, so as to fix the fixing portion 105A in the corresponding bar-shaped groove 111.
Fig. 4 is a side view of the ring support shown in fig. 1, and fig. 5 is a perspective view of the ring support shown in fig. 1. As shown in fig. 1 and 4-5, in an alternative embodiment, the lower end 202 of the ring-shaped support 100 is provided with a gap 108, the gap 108 is a partial lattice defect formed on the circumference of the ring-shaped support 100 along the axial direction of the ring-shaped support 100 from the opening at the lower end of the ring-shaped support, that is, at least two diamond-shaped lattices in a first row of diamond-shaped lattices arranged along the circumferential direction of the ring-shaped support 100 are separated by a gap 108, the gap 108 may be triangular, and in fig. 1, any two diamond-shaped lattices in the first row of diamond-shaped lattices arranged along the circumferential direction of the ring-shaped support 100 are separated by a gap 108. The void 108 is used to avoid pinching the conductive bundle by adjusting the alignment of the void 108 with the right coronary sinus side when the heart valve prosthesis is implanted low in the patient. Wherein the voids 108 may be uniformly or non-uniformly distributed along the circumferential direction of the ring stent 100 to facilitate adjusting the direction of implantation of the heart valve prosthesis.
In an alternative embodiment, as shown in fig. 4, a plurality of spike structures 106 are also provided on the outer contoured surface adjacent the middle region of the ring stent 100 to penetrate into the calcified native leaflets or annulus when the heart valve prosthesis is implanted in a patient, for assisting in securing the ring stent 100 in place, preventing valve migration toward the aorta. The plurality of spike structures 106 may be uniformly distributed along the circumferential direction of the annular bracket 100, so as to enhance the stability of the fixing and positioning.
Meanwhile, the spike structure 106 and the annular bracket 100 are an integrated structure formed by cutting the same pipe, so that the process difficulty and the production cost are further reduced. In addition, the material of the spike structure 106 may be a shape memory alloy so as to be attached to the annular stent 100 when the annular stent 100 is in a contracted state, and to be protruded from the annular stent 100 when the annular stent 100 is in an expanded state, so as to facilitate loading and delivery of the heart valve prosthesis, and so as to maintain an included angle of 60 ° to 120 °, for example, an included angle of 60 °, 85 °, 90 °, 115 ° or 120 °, with an outer profile surface of the annular stent 100 when the annular stent 100 is in an expanded state, so as to ensure that the spike structure 106 can penetrate into a predetermined position.
In the above-mentioned heart valve prosthesis embodiment, the support structure is arranged on the annular bracket, so that when the annular bracket is in an expanded state (i.e. the heart valve prosthesis is implanted in a patient), the support structure can provide additional radial support force for the annular bracket, so as to effectively promote the tension at the position of the orifice of the heart valve prosthesis, and ensure that the valve of the whole heart valve prosthesis has a preset effective opening area; meanwhile, due to the fact that the gap is formed in the lower end of the annular support, the direction of the implanted valve can be adjusted, the gap at the lower end can be aligned with the side of the right coronary sinus, so that conduction block complications caused by extrusion of a conducting beam by the annular support can be effectively avoided, and when the annular support is expanded due to the fact that the gap is formed in the annular support, the supporting force of the annular support is insufficient, and the additional supporting force provided by the supporting structure effectively solves the problem. In addition, the supporting rods distributed along the circumferential direction of the annular support and the spike structures arranged on the annular support can effectively enlarge the effective height range of the heart valve prosthesis during implantation, so that the annular support can be ensured to prop open the primary tissue even if dislocation (such as high-level or low-level implantation) occurs during implantation of the heart valve prosthesis.
Fig. 6 is a schematic view of a conveyor in a contracted state in one embodiment. A conveyor may include a conical head 301, an inner tube 305, a horn section 302 of a control handle (not shown), a sheath 303, and a fixed head 304, the distal end of the sheath 303 being connected to the horn section 302, the proximal end of the sheath 303 being connected to the control handle, the distal end of the inner tube 305 being connected to the fixed head 304, the proximal end being connected to the control handle. The sheath 303 and the inner tube 305 have an annular chamber therebetween, and the heart valve prosthesis (in a compressed state) of any of the above embodiments is received in the chamber of the sheath 303 to facilitate loading of the heart valve prosthesis into a patient for replacement of the diseased aortic valve. The horn section 302 is coated with a polymer material, and may be a structure woven from a shape memory alloy such as nickel-titanium alloy, copper-nickel alloy, copper-aluminum alloy, copper-zinc alloy, or iron alloy, and is capable of contracting and expanding (i.e., expanding) under a small pressure condition, and is in a horn shape when in a contracted state, and is in a hollow cylinder with the same diameter as the sheath 303 when in an expanded state.
As shown in fig. 1 to 4, the openings at the upper end of the ring-shaped stent 100 are provided with hanging lugs 104 which are fixed on the fixing heads 304 in a one-to-one correspondence manner, so as to load the heart valve prosthesis at a preset position in the patient, and then the aortic valve with lesions is replaced by using the artificial valve. As shown in fig. 6, a guide wire 307 is inserted through the inner core 306, and both ends of the guide wire are passed out of the conical head 301 and the control handle, wherein the control handle can be used to control the advancing and retracting of the sheath 303, the inner tube 305 and the inner core 306.
Unlike the above-described embodiment, in another embodiment, as shown in fig. 7, the taper head 301 is in contact with the sheath 303, and the surface of the taper head 301 is coated with a polymer material, and is constructed by braiding with a shape memory alloy such as nickel-titanium alloy, copper-nickel alloy, copper-aluminum alloy, copper-zinc alloy, iron alloy, or the like, so as to be able to contract and expand (i.e., expand or expand) under a small pressure.
In practical applications, the heart valve prosthesis is loaded into the delivery sheath as shown in fig. 6 in a low temperature environment such as an in vitro ice-water bath, specifically, the horn section 302 and the sheath 303 can be sequentially withdrawn to expose the fixation head 304; wherein, when the fixed head 304 is retracted, the horn section 302 can be expanded into a hollow cylinder with the same diameter as the sheath 303 by using external force. Next, the lugs 104 on the toroidal support 100 are snapped into corresponding detents of the fixed head 304 and the inner core 306 is connected to the conical head 301 through the sleeve 110 of the toroidal support 100. The horn 302 and sheath 303 are then advanced to load the prosthetic valve-loaded, compressed annular stent 100 into sheath 303, remove the external force applied to horn 302, and allow horn 302 to return to its original state, and engage cone head 301 to complete the loading of the heart valve prosthesis.
Thereafter, the delivery device is passed through the guidewire 307, passed through the arch along the femoral artery to the diseased aortic valve site, the horn section 302 and sheath 303 are withdrawn, the horn section 302 is expanded to fully expose the fixation head 304, the lugs 104 are now detached from the fixation head 304, and the annular stent 100 is mated with the native annulus to gradually release the heart valve prosthesis, while the sleeve 110 has not yet been detached from the inner core 306; wherein, during release of the heart valve prosthesis, the annular stent 100 may prop open the native leaflets against calcified plaque at the leaflets or annulus, and the horn section 302 may expand into a hollow cylinder of the same diameter as the sheath 303. Finally, after the heart valve prosthesis is completely released, the inner tube 305 is withdrawn, allowing the sleeve 110 to pass through the fixed head 304, the inner core 306 is withdrawn, until the conical head 301 is withdrawn from the conveyor through the sleeve 110, at which time the sleeve 110 is completely disengaged from the inner core 306, the horn section 302 is rapidly retracted to the original state, and the heart valve prosthesis is loaded to a predetermined position.
In the embodiment of the conveyor described above, the conical head 301 is sized smaller than the inner diameter of the sleeve 110 so that the conical head 301 can be threaded out of the sleeve 110 after the ring support 100 is released; meanwhile, since the size of the conical head 301 is far smaller than the diameter of the sheath 303, a horn section 302 is arranged between the conical head 301 and the sheath 303 to play a role in connection and smoothness, so that the vascular wall of the sheath 303 is prevented from being scratched when the sheath 303 is implanted into a human body. In addition, the horn section 302 is made of a shape memory alloy material, so that the horn section 302 is a hollow cylinder with two ends having the same diameter when in an expanded state (i.e., a deployed state), so that the ring support 100 can pass through the horn section 302 when being loaded and released.
Unlike the above-described embodiments, in another embodiment, as shown in fig. 7, the heart valve prosthesis is loaded into the delivery sheath in a low temperature environment such as an in vitro ice-water bath, and in particular, as shown in fig. 7, the sheath 303 may be withdrawn sequentially to expose the fixation head 304; secondly, the hanging lugs 104 on the annular bracket 100 are clamped into the corresponding clamping grooves of the fixing heads 304, at this time, the conical heads 301 deform under the extrusion of the sleeves 110 to drive the inner cores 306 connected with the conical heads to penetrate through the sleeves 110, and then the sheath 303 is pushed forward, so that the annular bracket 100 loaded with the artificial valve and in a compressed state is loaded into the sheath 303, and the loading operation of the heart valve prosthesis is completed.
Thereafter, the delivery device is passed through the guidewire 307, passed through the arch along the femoral artery to the diseased aortic valve site, the sheath 303 is withdrawn, the lugs 104 are now detached from the fixation heads 304, and the annular stent 100 is mated with the native annulus to gradually release the heart valve prosthesis, while the sleeve 110 has not yet been detached from the inner core 306; wherein, during release of the heart valve prosthesis, the annular stent 100 can prop open the native leaflets against calcified plaque at the leaflets or annulus; inner tube 305 is then withdrawn such that sleeve 110 passes over fixed head 304, inner core 306 is withdrawn until tapered head 301 is deformed and the delivery device is withdrawn through sleeve 110, at which point sleeve 110 is completely disengaged from inner core 306 and the heart valve prosthesis is loaded into place.
In summary, in the implantable heart valve prosthesis and the conveyor according to the embodiments of the present invention, the support structure disposed at the position of the orifice of the stent can provide an additional radial supporting force to the annular stent when the annular stent is in the deployed state, so as to effectively raise the tension at the position of the orifice of the heart valve prosthesis, and ensure that the valve of the whole heart valve prosthesis has a predetermined effective opening area; meanwhile, due to the fact that the gap is formed in the lower end of the annular support, the direction of the implanted valve can be adjusted, the gap at the inflow channel can be aligned with the side of the right coronary sinus, and therefore conduction block complications caused by extrusion of the annular support to pass bundles can be effectively avoided. In addition, the supporting rods distributed along the circumferential direction of the annular support and the spike structures arranged on the annular support can effectively enlarge the effective height range of the heart valve prosthesis during implantation, so that the annular support can be ensured to prop open the primary tissue even if dislocation occurs during implantation. In addition, the conveyer designed based on the heart valve prosthesis can play a role in connection and smoothness through the special horn section or the special conical head, so that the vessel wall is prevented from being scratched when the sheath tube is implanted into a human body.
The technical features of the above-described embodiments may be arbitrarily combined, and all possible combinations of the technical features in the above-described embodiments are not described for brevity of description, however, as long as there is no contradiction between the combinations of the technical features, they should be considered as the scope of the description.
The above examples illustrate only a few embodiments of the invention, which are described in detail and are not to be construed as limiting the scope of the invention. It should be noted that it will be apparent to those skilled in the art that several variations and modifications can be made without departing from the spirit of the invention, which are all within the scope of the invention. Accordingly, the scope of protection of the present invention is to be determined by the appended claims.
Claims (15)
1. A heart valve prosthesis, comprising:
An expandable ring stent, the ring stent having a diamond-shaped mesh structure;
A prosthetic valve disposed on the annular support;
An expandable support structure coupled to the toroidal support and expanding as the toroidal support expands and contracting as the toroidal support contracts;
wherein the support structure is configured to provide a support force to the ring support in a radial direction of the ring support when the ring support is in an expanded state;
The support structure comprises a sleeve and a plurality of support rods, wherein the sleeve and the annular support are coaxially arranged, and two ends of each support rod are respectively connected with the sleeve and the annular support.
2. The heart valve prosthesis of claim 1, wherein the annular stent is a stent made of a shape memory alloy.
3. The heart valve prosthesis of claim 1, wherein the annular stent has an upper end and a lower end opposite the upper end, the prosthetic valve comprising interconnected leaflets and a skirt disposed at the lower end, and the support structure disposed at the upper end.
4. The heart valve prosthesis of claim 3, wherein the support structure is located one fifth to one half of the annular stent at an opening from the upper end and the skirt is located one sixth to one third of the annular stent at an opening from the lower end.
5. The heart valve prosthesis of claim 1, wherein the plurality of support struts are distributed along a circumferential direction of the annular stent for providing support forces in a radial direction to the annular stent.
6. The heart valve prosthesis of claim 1, wherein the plurality of support struts and the annular stent are of unitary construction cut from the same tube.
7. The heart valve prosthesis of claim 1, wherein the support bar comprises a fixed portion, a turnover portion, and a support portion connected in sequence;
The fixing part is used for being fixed on the sleeve, the supporting part is used for being connected with the annular bracket, and the turnover part is used for keeping a supporting angle between the fixing part and the supporting part.
8. The heart valve prosthesis of claim 7, wherein the support angle ranges from 60 ° to 120 ° when the ring stent is in the expanded state.
9. The heart valve prosthesis of claim 8, wherein the support angle is 90 °.
10. The heart valve prosthesis of claim 7, wherein the support angle is 180 ° when the ring stent is in the contracted state.
11. The heart valve prosthesis of claim 7, wherein the sleeve has a plurality of grooves formed in an outer surface thereof;
The extending direction of the strip-shaped groove is parallel to the axial direction of the sleeve, and the fixing parts of the support rods are embedded and fixed in the strip-shaped groove in a one-to-one correspondence mode.
12. The heart valve prosthesis of claim 11, wherein the sleeve is a hollow post structure; a plurality of first through holes are formed in the strip-shaped groove along the axial direction of the sleeve; a plurality of second through holes are formed in the fixing part corresponding to the first through holes;
the fixing part is fixed in the strip-shaped groove by sequentially penetrating the first through hole and the second through hole corresponding to the first through hole through the suture line.
13. The heart valve prosthesis of claim 3, further comprising:
The hangers are uniformly and fixedly arranged at the opening of the upper end of the annular bracket along the circumferential direction and are used for loading the heart valve prosthesis.
14. The heart valve prosthesis of claim 3, wherein the lower end of the annular stent is provided with a void, and the void is a partial lattice defect formed in the circumferential direction of the annular stent along the axial direction of the annular stent from the opening at the lower end of the annular stent.
15. The heart valve prosthesis of claim 14, wherein the number of voids is one or more.
Priority Applications (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201711487720.5A CN109984868B (en) | 2017-12-30 | 2017-12-30 | Heart valve prosthesis and delivery device |
| PCT/CN2018/117162 WO2019128582A1 (en) | 2017-12-30 | 2018-11-23 | Heart valve prosthesis and conveyor |
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| Application Number | Priority Date | Filing Date | Title |
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| CN201711487720.5A CN109984868B (en) | 2017-12-30 | 2017-12-30 | Heart valve prosthesis and delivery device |
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| CN109984868B true CN109984868B (en) | 2024-08-06 |
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| WO (1) | WO2019128582A1 (en) |
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| CN112641537A (en) * | 2019-10-12 | 2021-04-13 | 上海微创心通医疗科技有限公司 | Heart valve support and prosthesis thereof |
| CN216257680U (en) * | 2020-07-06 | 2022-04-12 | 杭州启明医疗器械股份有限公司 | Sheath distal end structure for conveying interventional instrument and sheath |
| CN114681126B (en) * | 2020-12-28 | 2025-02-18 | 杭州德晋医疗科技有限公司 | Multi-stent valve expander and valve expansion system |
| CN114762630A (en) * | 2020-12-30 | 2022-07-19 | 先健科技(深圳)有限公司 | Covered stent and conveyer |
| CN113977593B (en) * | 2021-09-26 | 2023-03-31 | 浙江大学 | Driving mechanism for robot frogman, humanoid mechanical arm and stepless bending and twisting |
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| WO2019128582A1 (en) | 2019-07-04 |
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