CN107252363B - Valve stent with reduced compressed length and valve replacement device with same - Google Patents

Valve stent with reduced compressed length and valve replacement device with same Download PDF

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Publication number
CN107252363B
CN107252363B CN201710364702.1A CN201710364702A CN107252363B CN 107252363 B CN107252363 B CN 107252363B CN 201710364702 A CN201710364702 A CN 201710364702A CN 107252363 B CN107252363 B CN 107252363B
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section
valve
transition section
length
net rack
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CN107252363A (en
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曾敏
罗拉里
王云兵
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Venus Medtech Hangzhou Inc
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Venus Medtech Hangzhou Inc
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart 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
    • A61F2/2412Heart 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
    • A61F2/2418Scaffolds therefor, e.g. support stents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart 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
    • A61F2/2409Support rings therefor, e.g. for connecting valves to tissue

Abstract

The invention discloses a valve stent capable of reducing the compression length and a valve replacement device with the valve stent, wherein the valve stent comprises a tubular support net frame, one section of the support net frame is a transition section, and the ratio of the axial length of the transition section before and after compression is equal to 1. The axial length of the transition section is at least 25% of the total length of the support frame. The transition section is composed of a plurality of straight rods extending along the axial direction of the valve support, and the straight rods are uniformly distributed along the circumferential direction. The valve stent with the reduced compression length can reduce the length change of the valve stent before and after compression, improve the bending compliance of the valve stent, simultaneously ensure that the valve stent keeps good compression performance and strength, ensure that a valve can smoothly reach an implantation position in a human body, and reduce the risk of vascular complications after operation.

Description

Valve stent with reduced compressed length and valve replacement device with same
The present application is a divisional application entitled "valve stent with reduced compressed length and valve replacement device having the same", filed on 2015, 3/26, and filed on application No. 201510136641.4.
Technical Field
The invention relates to the technical field of medical equipment, in particular to a valve stent capable of reducing the compression length and a valve replacement device with the valve stent.
Background
Fallo tetrad is the most common cyanotic congenital heart disease in living infants, and the morbidity accounts for 10-15% of all types of congenital heart diseases.
The Fallofours disease consists of four malformations: (1) pulmonary artery stenosis, which is a common stenosis at the infundibulum, and then a combined stenosis at the infundibulum and the valve, and the degree of stenosis can be aggravated with age; (2) ventricular septal defect, which is a defect of the high-order membrane; (3) the aorta straddles above the left ventricle and the right ventricle, and the right straddling phenomenon can be gradually aggravated along with the development of the aorta, and about 25 percent of patients are the arch of the right aorta; (4) right ventricular hypertrophy, which is the result of increased right ventricular load following pulmonary artery stenosis. Of the four malformations, pulmonary artery stenosis has the greatest pathophysiological effect on infants.
In the procedure of the french tetrad surgery, when a doctor repairs a stenosis of a pulmonary artery, a pulmonary valve or a right ventricular infundibulum, the doctor generally implants a patch at a corresponding position to solve the problem of the stenosis of a main pulmonary artery, a pulmonary artery branch or a pulmonary valve. However, this surgery is only a palliative treatment, which often results in the loss of the pulmonary valve, and the infant still needs to be treated for the loss of the pulmonary valve until it grows into an adult.
Aiming at the problem of pulmonary valve loss of adult children, the valve can be implanted by a secondary chest opening operation, and the valve can also be implanted by an intervention method and an artificial pulmonary valve. Compared with a surgical operation, the interventional method can greatly reduce the operation trauma of a patient and provides another treatment way for the patient who cannot bear the surgical operation.
After the infant patient passes through the first patch surgery, the aorta is soft and the diameter is enlarged, so that the length and the diameter of the artificial pulmonary valve to be implanted are large. The pulmonary valve stent in the prior art is placed in a sheath in a compressed state before being implanted into a human body, and is released from the sheath after being conveyed into the human body by the sheath, so that the released pulmonary valve stent is restored to a natural state to play a role in supporting a prosthetic valve.
For example, chinese patent application publication No. CN103431931A discloses a valve stent, which includes a tubular support net frame, and an inflow section and an outflow section connected to two axial ends of the support net frame and radially expanded to form flares, wherein a plurality of first cells distributed circumferentially are disposed on the support net frame adjacent to the outflow section, and the first cells are diamond-shaped.
When the main body part of the pulmonary valve support adopts a diamond structure, the size change before and after compression is large no matter in the length direction or the diameter direction, the implantation path of the pulmonary valve sequentially passes through the vein, the right atrium, the right ventricle and the main pulmonary artery, the curvature of the implantation path is large, and if the length of the compressed pulmonary valve is too long, the compliance of the device in the conveying process is seriously influenced, and the conveying difficulty is increased.
Disclosure of Invention
The invention provides a valve stent with reduced compression length, which can reduce the length change of the valve stent before and after compression, improve the bending compliance of the valve stent, ensure that a valve can smoothly reach an implantation position in a human body, ensure the smooth operation of an operation process and reduce the risk of vascular complications after the operation.
A valve stent capable of reducing the compressed length comprises a tubular supporting net frame, wherein one section of the supporting net frame is a transition section, and the ratio of the axial length of the transition section before and after compression is equal to 1.
When a heart valve stent in the prior art is delivered into a human body through a delivery system, the heart valve stent is usually compressed and placed on an instrument loading part of the delivery system, and the instrument loading part on which the heart valve stent is placed is the hardest part in the whole sheath.
The support frame in the present invention refers to a portion of the valve stent, excluding the positioning members, for opening the blood vessel, and is generally tubular, and blood flows inside the tubular portion to interact with the prosthetic valve inside the tubular portion. The support frame is not limited to a cylindrical shape extending in an equal diameter, and the end of the support frame may be expanded or contracted in the radial direction.
In order to reduce the length of the support net rack after compression, the transition section is arranged on the support net rack, and the axial length of the transition section is kept unchanged before and after compression.
Preferably, the axial length of the transition section is at least 25% of the total length of the support frame. Only when the ratio of the axial length of the transition section to the total length of the support net rack reaches more than 25 percent, the effect of the transition section can be displayed, namely, the length of the compressed support net rack can be reduced to meet the requirement of bending compliance based on the existence of the transition section, so that the support net rack can smoothly reach the expected position in the human body, and the smooth operation is ensured.
Although the transition section can reduce the axial length change before and after the compression of the support net rack, the length of the transition section is not as long as possible, because the axial length change is larger before and after the compression of the rhombic grid, but the structure of the rhombic grid can ensure that the support net rack has enough strength and can bear long-time blood scouring, and the structure of the rhombic grid enables the support net rack to be compressed so as to be placed in the sheath tube.
Therefore, the axial length of the transition section is preferably 40-90% of the total length of the support net frame. Further preferably, the axial length of the transition section is 50-80% of the total length of the support net rack.
In the simplest embodiment, the transition section is formed by a plurality of straight rods extending in the axial direction of the valve support, and the straight rods are uniformly arranged in the circumferential direction.
The straight rod extends along the axial direction of the valve support, the length of the straight rod is the axial length of the transition section, the axial length is evenly distributed along the circumferential direction, the symmetry of the integral structure of the support net rack can be guaranteed, when the blood vessel is subjected to blood flow scouring for a long time, the stress is even, the inclined side is not easy to occur, and therefore injury is caused to the blood vessel wall.
Preferably, the axial two ends of the support net rack are connected with an inflow section and an outflow section, and the two ends of the transition section are connected with the inflow section and the outflow section through a grid section or directly.
When the transition section is connected with the inflow section or the outflow section through the grid section, the transition section and the grid section together form the support net rack.
The inflow section and the outflow section are flared, so that the valve stent is not easy to displace along with the movement of the heart after being implanted into a human body.
When released in the human body, the inflow section and the outflow section of the valve stent are both possibly the release-first ends, and the inflow section or the outflow section at the release-first ends is called the flaring section. The flaring section is connected with all end nodes on the corresponding side of the supporting net rack.
All end nodes are connected with the flaring sections, so that isolated peaks are prevented from appearing at the non-end part of the valve stent, and the phenomenon of sharp pricks after the valve stent is compressed into a sheath tube is eliminated.
The outer edge of the flaring section is surrounded by a plurality of bent supporting bars, and end nodes on the supporting net rack corresponding to the supporting bars are connected with the supporting bars. The end nodes intersect on the support bar or are connected to the support bar through meeting guide bars.
All the end nodes are directly connected or connected onto the supporting bars through the connecting bars, namely, the end nodes which exist in an isolated mode do not exist on the supporting net rack, each end node is at least connected with three linear edges, and when the whole valve stent is compressed, the end nodes cannot be deformed into spikes.
The two ends of each supporting strip are respectively connected with one end node of the supporting net rack, the middle part of each supporting strip extends along the axial direction of the supporting net rack, and the part of each supporting strip, which is adjacent to the end node, is bent outwards to form a flaring. The extension path from the corresponding end node to the support strip gradually deviates from the support net rack.
The guide bar is also bent to a proper degree corresponding to the bent shape of the support bar, and the guide bar and the support bar are positioned on the same smooth curved surface.
Preferably, the included angle between the connecting line of the two end points of the extending path and the axis of the valve support is 0-70 degrees. When the extending path forms an angle of 0 degrees with the axis of the valve support, the length of the guide strip is shortest, but because the guide strip and the support strip both have a bent structure, the extending path of the guide strip is generally not parallel to the axis of the valve support. The guide bars need to be converged on the support bars, and in order to match the shape of the support bars, the extending paths of the guide bars are not easy to have a large included angle with the axis of the valve support.
Preferably, the included angle between the connecting line of the two end points of the extending path and the axis of the valve support is 20-60 degrees. Preferably, the included angle between the connecting line of the two end points of the extending path and the axis of the valve support is 30-45 degrees.
The connecting and guiding strips are connected with the nearest support strips, and the included angle of the intersection parts of the connecting and guiding strips and the support strips is an acute angle. The structure is easy to maintain the original mechanical property.
Every adjacent four end nodes are used as a group, in a group of end nodes, two ends of the supporting bar are respectively connected with two end nodes which are farthest away, two end nodes positioned in the middle are respectively connected to the supporting bar on the corresponding side through a leading bar, the two leading bars are not intersected with each other, and the intersected position of each leading bar and the supporting bar is approximately positioned in the middle of the axial direction of the flaring section.
In order to retain the existing valve stent structure to the maximum extent and make the processing of the valve stent easier, preferably, the mesh section is a diamond mesh, and the ends of the straight rods of the transition section are connected with the corresponding diamond vertexes.
The ends of the straight rods are connected with the corresponding rhombic vertexes, firstly, the straight rods are easier to control to be uniformly arranged along the circumferential direction based on the symmetrical structure of the rhombic grids, so that the processing is easier to carry out, secondly, the exposed end points on the valve stent are fewer, and a sheath tube or a blood vessel is not easy to puncture.
Preferably, the ends of the straight rods of the transition section are connected with the diamond-shaped peaks of the diamond-shaped grids facing the transition section.
Two ends of each straight rod are respectively connected with one rhombic vertex, two adjacent straight rods and the corresponding sides of the rhombus connected with the straight rods form a hexagonal structure, and each internal angle of the hexagon is an obtuse angle. By adopting the structure, the number of exposed peaks of the diamond shape can be reduced to the maximum extent, so that the valve stent has better use safety.
The rhombic grids are not rhombic in a strict sense, all sides of the rhombuses can be slightly bent, and each rhombic grid forms a structure which is relatively close to a circle, so that stress concentration points when the stress is applied are reduced.
The invention also provides a valve replacement device, which comprises the valve bracket and a prosthetic valve fixed in the supporting net rack.
The support net frame and the inflow section of the valve stent are coated with films, and the prosthetic valve can be sewn on the inner wall of the valve stent and can also be installed and fixed by adopting other existing methods.
The valve stent with the reduced compression length can reduce the length change of the valve stent before and after compression, improve the bending compliance of the valve stent, simultaneously ensure that the valve stent keeps good compression performance and strength, ensure that a valve can smoothly reach an implantation position in a human body, and reduce the risk of vascular complications after operation.
Drawings
FIG. 1 is a schematic view of a first embodiment of a reduced length valve stent;
FIG. 2 is a perspective view of a first embodiment of a reduced length valve stent;
FIG. 3 is a schematic view of a second embodiment of a reduced compressed length valve stent (the back half omitted);
FIG. 4 is a schematic view of an aortic stent having a reduced compressed length.
In the figure: 1. an outflow section; 2. a grid section; 3. a transition section; 4. an end node; 5. an inflow section; 6. a supporting strip; 7. a straight rod; 8. connecting a guide strip; 9. a grid section; 10. an inflow section; 11. a transition section; 12. a straight rod; 13. a grid section; 14. a grid section; 15. and (4) an outflow section.
Detailed Description
Example 1
The present invention will be further explained by taking a valve stent as an example with reference to the attached drawings.
As shown in fig. 1 and 2, the valve stent with reduced compression length comprises a support frame, and an inflow section 5 and an outflow section 1 which are respectively connected to the two axial ends of the support frame, wherein one section of the support frame is a transition section 3.
One end of the transition section 3 is connected with the inflow section 5 through the grid section 13, the other end of the transition section 3 is connected with the outflow section 1 through the grid section 2, and the grid section 2, the grid section 13 and the transition section 3 jointly form a supporting grid frame. The grid section 2 is composed of continuous diamonds, the grid section 13 is composed of continuous semi-diamonds, the inflow section 5 expands outwards in the radial direction to form a flaring compared with the transition section 3, the sides of the diamonds are not strictly straight lines but slightly bent outwards, and the numbers of the diamonds or semi-diamonds in the circumferential direction of the inflow section 5, the grid section 2 and the grid section 13 are the same.
The transition section 3 is composed of a plurality of straight rods 7 extending along the axial direction of the valve support, each straight rod 7 is evenly distributed along the circumferential direction, and the axial length of the transition section 3 is 70% of the total length of the support net rack.
The ends of the straight rods 7 of the transition section 3 are connected with the corresponding rhombic vertexes, and the ends of the straight rods 7 of the transition section 3 are connected with the rhombic vertexes of the rhombic grids facing the transition section 3. As can be seen from fig. 1, each straight rod 7 of the transition section 3 and the adjacent rhombic side form a hexagon, and each internal angle of the hexagon is an obtuse angle.
Example 2
This embodiment eliminates the presence of isolated end nodes in the valve stent, except for the same configuration of the transition section 3 as in embodiment 1.
As shown in figure 3, the radial expansion of the inflow section 5 and the outflow section 1 is flaring, when the human body is released, the outflow section 1 of the valve stent is a release-first end, and the outflow section 1 is connected with all end nodes 4 on the corresponding side of the supporting net rack. The back half of the valve stent is omitted in fig. 3, and only the front half of the valve stent is shown.
The outer edge of the outflow section 1 is surrounded by a plurality of bent support bars 6, every adjacent four end nodes 4 are used as a group, in a group of end nodes 4, a support bar 6 and two leading bars 8 are arranged, two ends of the support bar 6 are respectively connected with the two end nodes 4 which are farthest away, the two end nodes 4 which are positioned in the middle are respectively connected to the support bars 6 on the corresponding side through the leading bars 8, the two leading bars 8 are not intersected with each other, and the intersected position of each leading bar 8 and the support bar 6 is approximately positioned in the middle of the outflow section 1 in the axial direction.
The extension path from the corresponding end node 4 to the support bar 6 of the connecting and guiding strip 8 gradually deviates from the support net rack, and the included angle of the intersection part of the connecting and guiding strip 8 and the support bar 6 is an acute angle.
Example 3
The present invention will be further explained by taking the aortic stent as an example with reference to the accompanying drawings.
As shown in FIG. 4, the aortic stent with reduced compressed length comprises a support frame, an outflow section 15 and an inflow section 10 connected to the axial ends of the support frame, wherein one section of the support frame is a transition section 11.
One end of the transition section is connected with the outflow section 15 through the grid section 9, the other end of the transition section 11 is connected with the outflow section 10 through the grid section 14, and the grid section 14, the grid section 9 and the transition section 11 jointly form a supporting grid frame. The mesh sections 14 and 9 are composed of continuous semi-rhombus, the inflow section 10 expands outwards in the radial direction to form a flaring compared with the transition section 11, and the sides of the rhombus are not strictly straight lines but are slightly bent outwards.
The transition section 11 is composed of a plurality of straight rods 12 extending along the axial direction of the aortic stent, each straight rod 12 is evenly distributed along the circumferential direction, and the axial length of the transition section 11 is 80% of the total length of the supporting net rack.
Two ends of each straight rod 12 of the transition section 11 are connected with the semi-rhombus vertexes of the corresponding grid section 14 and the corresponding grid section 9, as can be seen from fig. 4, each straight rod 12 of the transition section 11 and the adjacent semi-rhombus side form a hexagon, and each internal angle of the hexagon is an obtuse angle.
The length of the compressed valve stent can be greatly reduced by adopting the technical scheme of the invention, and the length increase variable value of the compressed length of the support net rack is n X on the assumption that n support net rack transition section axial diamond-shaped units are provided, and the axial increase of each diamond-shaped unit after compression is X compared with that before compression; by contrast, if the rhombus lattice of the transition section is changed into a straight line, half rhombus lattices are respectively left at the two ends of the transition section, the length of the support net rack before and after compression is changed into 1X, and the axial length change amount of the straight line part before and after compression is zero'. Examples are as follows: in the most common self-expandable valve stent at present, a support net rack is completely formed by rhombic grids, for example, the most common 30# valve is adopted, 12 rhombic grids are distributed in the circumferential direction, the length of a straight section for fixing the valve is 30mm, 4 rhombic grids exist in the axial direction, when the valve stent is compressed, the rhombic grids become straight lines, and the length of the straight section is changed to be about 43.04 mm; after the technical scheme provided by the invention is adopted, half diamond lattices are respectively remained at two ends of the transition section 3, the length of the compressed straight section is about 33.26mm, the compressed length of 9.78mm is reduced, and the effect is obvious.
In addition, the invention can reduce the consumption of metal materials (usually memory alloy, the invention adopts nickel-titanium memory alloy) used by the valve stent by nearly half, not only can reduce the diameter of the valve stent after being compressed, but also can improve the bending compliance, and further improve the passing performance of the valve.
The valve replacement device provided by the invention comprises the valve bracket and the prosthetic valve fixed in the supporting net rack. After the valve stent enters a preset position of a human body through the conveying system, the valve stent is released and expanded from the sheath tube, and the prosthetic valve fixed inside the valve stent replaces the original valve in the human body, so that the function of enabling blood to pass in a single direction is realized.

Claims (5)

1. A pulmonary artery stent capable of reducing the compression length comprises a tubular supporting net rack and is characterized in that one section of the supporting net rack is a transition section, the ratio of the axial length of the transition section before and after compression is equal to 1, the transition section is composed of a plurality of straight rods extending along the axial direction of the pulmonary artery stent, and the straight rods are uniformly distributed along the circumferential direction; the axial length of the transition section is at least 25% of the total length of the support net rack;
the axial two ends of the supporting net rack are connected with an inflow section and an outflow section, the outer edge of the outflow section is surrounded by a plurality of bent supporting bars, end nodes corresponding to the supporting bars on the supporting net rack are connected with the supporting bars, part of the end nodes in the end nodes corresponding to the supporting net rack and the outflow section are intersected on the supporting bars, and the rest end nodes are cut into the intersection through the guide bars and are connected to the supporting bars; the included angle of the intersection part of the guide bar and the support bar is an acute angle;
the middle part of each supporting strip is provided with a bending part, the edge of the supporting net rack adjacent to the outflow section is a folding line, and the included angle formed by the adjacent folding lines connecting different guide connecting strips is smaller than the included angle of the bending part;
the extension path from the corresponding end node to the support bar gradually deviates from the support net rack; the included angle between the connecting line of the two end points of the extension path and the axis of the pulmonary artery stent is 0-70 degrees;
the two ends of the transition section are connected with the inflow section and the outflow section through the grid sections, and each straight rod of the transition section and the edge of the adjacent grid section form a hexagon; the inflow section has a diameter greater than the diameter of the transition section.
2. The pulmonary artery stent of reduced compression length of claim 1, wherein the axial length of the transition section is 40 to 90% of the total length of the support frame.
3. The pulmonary artery stent of reduced compression length of claim 2, wherein the mesh segments are diamond-shaped meshes, and the ends of the straight rods of the transition segments are connected with the corresponding diamond-shaped vertices.
4. The pulmonary artery stent of reduced compression length of claim 3, wherein the ends of the straight rods of the transition section are connected to the diamond-shaped lattice towards the diamond-shaped vertices of the transition section.
5. A valve replacement device comprising a pulmonary artery stent as defined in any one of claims 1 to 4, and a prosthetic valve secured within the support frame.
CN201710364702.1A 2015-03-26 2015-03-26 Valve stent with reduced compressed length and valve replacement device with same Active CN107252363B (en)

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CN104720937A (en) 2015-06-24
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CN104720937B (en) 2017-09-26

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