CN109567979A - A kind of valved conduit and the method for making valved conduit - Google Patents

A kind of valved conduit and the method for making valved conduit Download PDF

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Publication number
CN109567979A
CN109567979A CN201811391631.5A CN201811391631A CN109567979A CN 109567979 A CN109567979 A CN 109567979A CN 201811391631 A CN201811391631 A CN 201811391631A CN 109567979 A CN109567979 A CN 109567979A
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CN
China
Prior art keywords
leaflet
tubular body
target
valved conduit
sewing
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CN201811391631.5A
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Chinese (zh)
Inventor
赵益民
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Bio Tech Ltd Of Jia Hezhong Nation Hangzhou
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Bio Tech Ltd Of Jia Hezhong Nation Hangzhou
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Priority to CN201811391631.5A priority Critical patent/CN109567979A/en
Publication of CN109567979A publication Critical patent/CN109567979A/en
Pending legal-status Critical Current

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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
    • A61F2/04Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06Blood vessels
    • 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
    • A61F2/04Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06Blood vessels
    • A61F2/064Blood vessels with special features to facilitate anastomotic coupling
    • 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
    • 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
    • A61F2/2475Venous valves
    • 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
    • A61F2/2496Devices for determining the dimensions of the prosthetic valve to be implanted, e.g. templates, sizers

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

Abstract

The present invention provides a kind of valved conduit and the method for making valved conduit, which includes: tubular body, sews at least three leaflets on the inside of tubular body respectively.The upper edge of each leaflet is mutually separated with tubular body, side is connected along with tubular body through sewing, so as to form valve pocket between the two;The length of the upper edge of leaflet, based on the upper edge of leaflet minimum wire length of two endpoints on tubular body and determine.When valved conduit is connected between right ventricle and lung, valve pocket is open towards lung;When right ventricle is shunk, channel of blood flow of the blood through being formed between each leaflet of right ventricle output flows to lung;When right ventricle diastole, channel of blood flow is closed so that the blood of reflux flows into the valve pocket with certain opening area.Therefore, blood backflow problem when this programme can alleviate right ventricle diastole.

Description

A kind of valved conduit and the method for making valved conduit
Technical field
The present invention relates to field of medical technology, in particular to a kind of valved conduit and the method for making valved conduit.
Background technique
There are pulmonary artery between heart and lung, venous blood is oriented to lung through right ventricle by pulmonary artery.
Currently, in the surgical intervention of many complexity heart diseases, it will usually use high molecular material pipeline and artificial bio-membrane Pipeline substitutes pulmonary artery, to rebuild pulmonary artery and right ventricle's efferent tract.When right ventricle is shunk, venous blood can manually be given birth to Conduit flows to lung.
But when right ventricle diastole, easily there is blood backflow situation in common high molecular materials pipeline and artificial bio-membrane's pipeline, lead Cause right heart insufficiency.
Summary of the invention
The present invention provides a kind of valved conduit and the methods for making valved conduit, can alleviate blood when right ventricle diastole Liquid reflux problem.
In order to achieve the above object, the present invention is achieved through the following technical solutions:
On the one hand, the present invention provides a kind of valved conduits, comprising:
Tubular body sews at least three leaflets on the inside of the tubular body respectively;
For any leaflet: the upper edge of the leaflet is mutually separated with the tubular body, the side of the leaflet It is connected along with the tubular body through sewing, so as to form valve pocket between the leaflet and the tubular body;The leaflet it is upper The length at edge meets formula one;
The formula one includes: a≤l≤(n-1) a;
Wherein, l is the length of the upper edge of the leaflet, and unit mm, a are two endpoints of the upper edge of the leaflet Minimum wire length on the tubular body, unit mm, n are the number of at least three leaflet.
Further, there is at least one layer of side sewing processing on the tubular body;
It is handled through seam-ripping, the tubular body is changed into sheet noumenon;
The length on the bottom edge edge of the sheet noumenon is not less than the perimeter of the tubular body.
Further, at least three leaflets integral type connection.
Further, the valved conduit further include: valve support, the valve support are connected at least three leaflets integral type, To organize integrated limb;
The height on the side edge of the integral type limb is not less than the depth of the valve pocket;
The width on the bottom edge edge of the integral type limb is not less than the perimeter of the tubular body;
The bottom edge edge and each side of the valve support are connected with the tubular body through sewing along equal.
Further, at least three leaflets horizontal continuity arrangement;
The a meets formula two;
The formula two includes:
Wherein, r is the radius of the tubular body, and unit mm, n are the number of at least three leaflet.
Further, which includes 3 leaflets;
When a=6mm, l=12mm;
When a=10mm, l=15mm;
When a=14mm, l=18mm;
When a=18mm, l=21mm;
When a=23mm, l=24mm.
Further, the r design so that the valved conduit connection right ventricle shrink when, the valve pocket it is effective Opening area meets formula three;
The formula three includes:
Wherein, the effective vent area of the valve pocket, unit are when s is the right ventricle contraction of valved conduit connection mm2, k1For the first default optimized coefficients, and k1>=1, V are the flow of blood when the right ventricle of valved conduit connection is shunk, Unit is mm3/ s, ν are the flow velocity of blood when the right ventricle of valved conduit connection is shunk, unit mm/s.
Further, the r design so that the valved conduit connection right ventricle diastole when, the valve pocket it is effective Opening area meets formula four;
The formula four includes:
Wherein, the effective vent area of the valve pocket, unit are when s ' is the right ventricle diastole of valved conduit connection mm2, k2For the second default optimized coefficients, and k2< 1.
Further, the material of the tubular body and the leaflet be bovine pericardium, Pigs Hearts packet, horse pericardium, mule pericardium, Any one animal pericardium in donkey pericardium.
On the other hand, the present invention provides a kind of methods for making valved conduit, according to the age predefined, averagely At least one of weight and average body surface area determine the radius of tubular body;According to the radius of the tubular body, determine The first size of sheet noumenon;According to the radius of the tubular body and the leaflet number that has predefined, the of leaflet is determined The length of two sizes, the upper edge for the leaflet for including in second size meets formula one;Further include:
S1: at least three mesh for meeting the target sheet noumenon of the first size, meeting second size are cut out Mark leaflet;
S2: respectively by the side of each target leaflet along sewing on the target sheet noumenon, so that described The upper edge of target leaflet is mutually separated with the target sheet noumenon, is formed between the target leaflet and the target sheet noumenon Valve pocket;
S3: handling through at least one layer of side sewing, the target sheet noumenon be sewn into target tubular body, to be made Valved conduit, wherein the target leaflet is located at the inside of the target tubular body;
The formula one includes: a≤l≤(n-1) a;
Wherein, l is the length of the upper edge of the target leaflet, and unit mm, a are the upper edge of the target leaflet Minimum wire length of two endpoints on the target tubular body, unit mm, n are at least three targets leaflet Number.
Further, before the S2, further comprise: sewing is set in each described target leaflet respectively Hole;On the target sheet noumenon, sewing holes corresponding with target leaflet described in each are respectively set;
It is described respectively to sew on the side edge of each target leaflet on the target sheet noumenon, comprising: needle Each target leaflet: based on being set in the sewing holes and the target sheet noumenon being arranged in current goal leaflet The sewing holes corresponding with the current goal leaflet set, sequence inserting needle cabling exist current goal leaflet sewing On the target sheet noumenon.
The present invention provides a kind of valved conduit and make valved conduit method, the valved conduit include: tubular body, At least three leaflets on the inside of tubular body are sewed respectively.The upper edge of each leaflet mutually separates with tubular body, side along with Tubular body is connected through sewing, so as to form valve pocket between the two;The length of the upper edge of leaflet, two of the upper edge based on leaflet Minimum wire length of a endpoint on tubular body and determine.When valved conduit is connected between right ventricle and lung, valve pocket It is open towards lung;When right ventricle is shunk, channel of blood flow of the blood through being formed between each leaflet of right ventricle output flows to lung;It is right When ventricular diastole, channel of blood flow is closed so that the blood of reflux flows into the valve pocket with certain opening area.Therefore, of the invention Blood backflow problem when right ventricle diastole can be alleviated.
Detailed description of the invention
In order to more clearly explain the embodiment of the invention or the technical proposal in the existing technology, to embodiment or will show below There is attached drawing needed in technical description to be briefly described, it should be apparent that, the accompanying drawings in the following description is the present invention Some embodiments for those of ordinary skill in the art without creative efforts, can also basis These attached drawings obtain other attached drawings.
Fig. 1 is a kind of schematic diagram for valved conduit that one embodiment of the invention provides;
Fig. 2 is the schematic diagram for another valved conduit that one embodiment of the invention provides;
Fig. 3 is a kind of valved conduit for providing of one embodiment of the invention through seam-ripping treated schematic diagram;
Fig. 4 is another valved conduit that provides of one embodiment of the invention through seam-ripping treated schematic diagram;
Fig. 5 is the top view of Fig. 3;
Fig. 6 is the left view of Fig. 3;
Fig. 7 is the schematic diagram for the leaflet that a kind of tubular body inside that one embodiment of the invention provides is sewed;
Fig. 8 is a kind of schematic diagram that leaflet is sewed on sheet noumenon that one embodiment of the invention provides;
Fig. 9 is a kind of method for making valved conduit that one embodiment of the invention provides.
Specific embodiment
In order to make the object, technical scheme and advantages of the embodiment of the invention clearer, below in conjunction with the embodiment of the present invention In attached drawing, technical scheme in the embodiment of the invention is clearly and completely described, it is clear that described embodiment is A part of the embodiment of the present invention, instead of all the embodiments, based on the embodiments of the present invention, those of ordinary skill in the art Every other embodiment obtained without making creative work, shall fall within the protection scope of the present invention.
As shown in Figure 1, may include: the embodiment of the invention provides a kind of valved conduit
Tubular body 101 sews at least three leaflets 102 in 101 inside of the tubular body respectively;
For any leaflet 102: the upper edge of the leaflet 102 is separated with 101 phase of tubular body, the valve The side of leaf 102 is connected along with the tubular body 101 through sewing, so that shape between the leaflet 102 and the tubular body 101 At valve pocket;The length of the upper edge of the leaflet 102 meets following formula (1);
a≤l≤(n-1)a (1)
Wherein, l is the length of the upper edge of the leaflet 102, and unit mm, a are the two of the upper edge of the leaflet 102 Minimum wire length of a endpoint on the tubular body 101, unit mm, n are of at least three leaflet 102 Number.
The embodiment of the invention provides a kind of valved conduits, including tubular body, respectively sew on the inside of tubular body At least three leaflets.The upper edge of each leaflet is mutually separated with tubular body, side is connected along with tubular body through sewing, so that two Valve pocket is formed between person;The length of the upper edge of leaflet, minimum of two endpoints of the upper edge based on leaflet on tubular body Wire length and determine.When valved conduit is connected between right ventricle and lung, valve pocket is open towards lung;Right ventricle is shunk When, channel of blood flow of the blood through being formed between each leaflet of right ventricle output flows to lung;When right ventricle diastole, channel of blood flow closing So that the blood of reflux flows into the valve pocket with certain opening area.Therefore, the embodiment of the present invention can alleviate right ventricle and relax Blood backflow problem when opening.
In detail, Fig. 1 can be the partial sectional view of a valved conduit.The tubular body of valved conduit shown in Fig. 1 Inside is sewed with 3 leaflets, and one of leaflet is not shown in Fig. 1.
In detail, there are upper edges and side edge for leaflet, and the sewing of side edge is when on tubular body, upper edge and tubulose sheet Body mutually separates, so as to form valve pocket between the two.To be capable of forming valve pocket, the length of the upper edge of leaflet can be defined, Than if you need to meet above-mentioned formula (1).The presence of valved conduit mesopetalum pocket, can be used for catching the blood of reflux, to avoid blood It is back in right ventricle.
In detail, valved conduit can connect between right ventricle and lung, and valve pocket is open towards lung.In this condition Under, it can recycle that there are following two kinds of situations:
Situation A: when right ventricle is shunk, the pressure of right ventricle side is greater than the pressure of lung side;Based on current pressure gradient, The upper edge of each leaflet tends on the inside of pipeline body, so that the effective vent area of each valve pocket reduces, with the shape between each leaflet At channel of blood flow;The blood of right ventricle output flows to lung through the channel of blood flow.
Situation B: when right ventricle diastole, the pressure of right ventricle side is less than the pressure of lung side;Based on current pressure gradient, The upper edge of each leaflet is far from the inside of pipeline body, so that the effective vent area of each valve pocket increases, to close between each leaflet Existing channel of blood flow;The blood of reflux flows into valve pocket.
In detail, tubular body can be integral type, for example can be one section of pulmonary artery pipe of a certain animal, can also To be by sheet noumenon through being sewn into.The former caliber is fixed, but the caliber of the latter can adjust on demand.Due to all ages and classes The pipe diameter size of Duan Renti pulmonary artery is not quite similar, therefore it is preferred that can make valved conduit using the latter.
Based on this, in an embodiment of the invention, Fig. 2, Fig. 3 or Fig. 4 is please referred to, is existed on the tubular body 101 At least one layer of side sewing processing;
It is handled through seam-ripping, the tubular body 101 is changed into sheet noumenon;
The length on the bottom edge edge of the sheet noumenon is not less than the perimeter of the tubular body 101.
In detail, Fig. 2 can be a kind of valved conduit obtained through 2 layers of side sewing processing, and Fig. 3 can be by Fig. 2 Shown in valved conduit seam-ripping slabbing when schematic diagram, Fig. 4 can be another valved conduit seam-ripping slabbing when schematic diagram.
In detail, Fig. 5 can be the top view of Fig. 3, and Fig. 6 can be the left view of Fig. 3.
There are 2 layers of sides to sew in Fig. 2, on valved conduit, respectively inboard sewing and outside sewing.Inboard sewing can To correspond to point C1With point E1Between sewing line, outside sewing can correspond to point D1With point F1Between sewing line.
Incorporated by reference to Fig. 2 and Fig. 3, when carrying out inboard sewing to the sheet noumenon shown in Fig. 3 for being sewed with leaflet, point C1 With point E1Between sewing line and point C2With point E2Between sewing line be overlapped, on the outside of further progress when sewing, point D1With point F1 Between sewing line and point D2With point F2Between sewing line be overlapped.
Incorporated by reference to Fig. 2 and Fig. 3 it is found that point D1With point F1Between sewing line, and accordingly, point D2With point F2Between Sewing line is discontinuous, is in two-part, to avoid normal folding of the leaflet position without influencing valve pocket.
As can be seen that the perimeter of valved conduit shown in Fig. 2, is equal to the midpoint Fig. 3 C1With point C2Between wire length, with And it is equal to the midpoint Fig. 3 D1With point D2Between wire length.
In detail, to guarantee to sew tight effect, the length on the bottom edge edge of sheet noumenon is not less than the perimeter of tubular body. Incorporated by reference to Fig. 2 and Fig. 3 it is found that the width L of sheet noumenon1Greater than the perimeter of respective tubular ontology, the height L of sheet noumenon2It is equal to The height of respective tubular ontology.
In Fig. 3,3 leaflet horizontal continuity arrangements, therefore after side sewing processing, it, should in valved conduit shown in Fig. 2 3 leaflets still keep horizontal continuity to arrange.
In Fig. 3, by taking the leaflet of the leftmost side as an example, two endpoints of the upper edge of the leaflet are respectively point A4With point A2, valve Leaf sews revealing all the details for formed valve pocket and is located at point B3.In this way, in Fig. 3, A4With point A2Between wire length correspond to above-mentioned formula (1) a value in.
It is handled through sewing, referring to FIG. 2, point A4With point A3It is overlapped.
Accordingly, in Fig. 2, two endpoints of the upper edge of the leaflet are respectively point A4With point A2, leaflet sewing formed Revealing all the details for valve pocket is located at point B3.In this way, in Fig. 2, A4With point A2Between close dotted line length correspond to above-mentioned formula (1) in a Value, the length of dilute dotted line correspond to the l value in above-mentioned formula (1).
In Fig. 2, plane where the pocket mouth of the formed valve pocket of 3 leaflets is parallel with valved conduit cross section.
With Fig. 3 correspondingly, Fig. 4 be another valved conduit seam-ripping slabbing when schematic diagram.To sewing path in Fig. 4 Obvious mark is carried out.Can be seen that side sewing processing includes two layers, and sewing corresponding sewing line in inboard is continuous, external latasuture Corresponding sewing line is made in two-part to avoid leaflet position.
Referring to FIG. 5, as can be seen that the sewing of each leaflet is formed by between leaflet and sheet noumenon when on sheet noumenon Valve pocket has certain effective vent area.Certainly, each leaflet size it is identical and sewing rule it is identical when, formed valve pocket phase Together, to show identical effective vent area in Fig. 5.
Referring to FIG. 6, as can be seen that the sewing of each leaflet is formed by between leaflet and sheet noumenon when on sheet noumenon Valve pocket has certain depth.
In detail, the bending degree of leaflet upper edge, the length of leaflet upper edge and sewing path can be to being formed The shape of valve pocket impacts.For example, when leaflet is sewn on sheet noumenon, on the basis of the cross section of Valved allograft, valve The pocket mouth plane of formed valve pocket can be following any implementations between leaf and ontology:
Mode 1: convex is presented;
Mode 2: being in horizontal type;
Mode 3: being in concave shape.
For example, the pocket mouth plane of Fig. 2 and valve pocket shown in Fig. 3 is in horizontal type;The pocket mouth plane of valve pocket shown in Fig. 4 is presented Convex.In detail, it is contemplated that valve pocket amount of capacity, it can in a preferred way 2.
In detail, the existing way of at least three leaflets to be sewed can for it is following any one:
Mode A: it is separated from each other between each leaflet;
The connection of B: at least three leaflet integral type of mode;
Mode C: including at least three leaflets on integral type limb.
In detail, when the existing way difference of leaflet, the sewing path of leaflet is corresponding to have difference.
In detail, for aforesaid way A:
Due to being separated from each other between each leaflet, therefore each leaflet can be sewn on sheet noumenon respectively.
For example, leaflet shown in Fig. 7 can be for an independent leaflet.Referring to FIG. 8, needing to sew 3 on sheet noumenon A leaflet, due to being separated from each other between each leaflet, therefore can based on the sewing holes being correspondingly arranged in leaflet and sheet noumenon, sequentially into Needle cabling is sewed.
In detail, for aforesaid way B:
When integral type connects between each leaflet, the secured performance of valve pocket can be optimized, so that being beneficial to extension valved conduit makes Use the time limit.For example, 3 leaflet integral types shown in Fig. 3 connect, and there are coupling parts between adjacent two leaflet, are such as located at Point A2With point A1Coupling part at position.
Therefore, in an embodiment of the invention, at least three leaflets, the 102 integral type connection.
In detail, for aforesaid way C:
Compared with mode B, the secured performance of valve pocket can be advanced optimized based on integral type limb.For example, in Fig. 4 Shown in 3 leaflets meet aforesaid way C.
Therefore, in an embodiment of the invention, referring to FIG. 4, the valved conduit further include: valve support 401, the valve support 401 connect at least three leaflets, 102 integral type, to organize integrated limb;
The height on the side edge of the integral type limb is not less than the depth of the valve pocket;
The width on the bottom edge edge of the integral type limb is not less than the perimeter of the tubular body 101;
The bottom edge edge and each side of the valve support 401 are connected with the tubular body 101 through sewing along equal.
Based on Fig. 4 as can be seen that integral type leaflet is made of valve support and 3 leaflets.
It is provided with two layers of side sewing path in Fig. 4, on sheet noumenon, the left side edge of integral type limb, bottom edge edge, Right edge, and including each leaflet side edge, corresponding sewing is on sheet noumenon.Certainly, to be capable of forming The upper edge of valve pocket, each leaflet that integral type limb includes mutually is separated with sheet noumenon.
In an embodiment of the invention, Fig. 2, Fig. 3 or Fig. 4, at least three leaflets, the 102 horizontal continuity row are please referred to Cloth;
The a meets following formula (2);
Wherein, r is the radius of the tubular body 101, and unit mm, n are the number of at least three leaflet 102.
In detail, horizontal continuity between each adjacent two leaflet is deposited between the upper edge of each leaflet that is, for two leaflet of arbitrary neighborhood In common endpoint.The arrangement of leaflet horizontal continuity, can alleviate or even avoid existing gap between two leaflets, with the blood of anti-return Liquid passes through from this gap, thus the problem of causing blood backflow to atrium dextrum.Under normal conditions, blood backflow easily causes the right side The problems such as heart function decline, right ventricle elasticity are deteriorated.
In detail, it when leaflet horizontal continuity is arranged, according to caliber and leaflet number, can be calculated based on above-mentioned formula (2) The specific value of a out, and then the value range of l can be calculated based on above-mentioned formula (1), and according to other factors, such as experience Value etc., to determine the specific value of l.
Based on above content, in an embodiment of the invention, which includes 3 leaflets 102;
When a=6mm, l=12mm;
When a=10mm, l=15mm;
When a=14mm, l=18mm;
When a=18mm, l=21mm;
When a=23mm, l=24mm.
For example, referring to FIG. 5, by taking the leaflet of the leftmost side as an example, two endpoints of the upper edge of the leaflet are respectively Point A4With point A2, wherein point A4With point A2Between straight line length be 18mm when, point A4With point A2Between length of a curve can be 21mm。
In detail, when a value determines, the selection of l value should can guarantee to be formed by valve pocket with required effective vent face Long-pending or pocket mouth size.In the case where valve pocket other factors, such as the fixation of valve pocket width, valve pocket depth, the effective vent of valve pocket Area is bigger, and valve pocket capacity is bigger, and the amount for the draining blood that can be accommodated is more.In this way, the adduction of each valve pocket capacity, Ying Bu little In possible blood backflow amount.
In addition, other than considering valve pocket capacity, the size of the effective vent area of valve pocket, it can also be ensured that can satisfy Following two kinds of situations:
Situation 1: under right ventricle contraction state, the effective vent area of each valve pocket can be as small as possible, so that each valve pocket Between channel of blood flow it is sufficiently large, with guarantee right ventricle output blood can flow to lung through channel of blood flow.
Situation 2: under right ventricle diastole state, the effective vent area of each valve pocket can be as big as possible, above-mentioned to close Channel of blood flow in situation 1, so that the channel of blood flow between each valve pocket is sufficiently small, the blood of reflux is flowed into valve pocket, avoids blood It is back to right ventricle.
In detail, for above situation 1:
In an embodiment of the invention, when the design of the r is so that the right ventricle of valved conduit connection is shunk, institute The effective vent area for stating valve pocket meets following formula (3);
Wherein, the effective vent area of the valve pocket, unit are when s is the right ventricle contraction of valved conduit connection mm2, k1For the first default optimized coefficients, and k1>=1, V are the flow of blood when the right ventricle of valved conduit connection is shunk, Unit is mm3/ s, ν are the flow velocity of blood when the right ventricle of valved conduit connection is shunk, unit mm/s.
Under above situation 1, in an embodiment of the invention, the V meets following formula (4);
Wherein, V is the flow of blood when the right ventricle is shunk, unit mm3/ s, C are cardiac output, unit L/ Min, 60 be the number of seconds for including per minute, and T is to be averaged the used time cardiac cycle, and unit s, t are that ventricular systole is averaged the used time, single Position is s.
In detail, T value and t value can be pre-set, for example, T=0.8s can be set, t=0.27s.
In detail, for above situation 2:
In an embodiment of the invention, the r design so that the valved conduit connection right ventricle diastole when, institute The effective vent area for stating valve pocket meets following formula (5);
Wherein, the effective vent area of the valve pocket, unit are when s ' is the right ventricle diastole of valved conduit connection mm2, k2For the second default optimized coefficients, and k2< 1.
In detail, the effective vent area of valve pocket is related with the length of leaflet upper edge.For example, the length of leaflet upper edge When too small, the variation range of the effective vent area of formed valve pocket is limited, and required opening and closing degree is not achieved.In this way, because l value with A value is related, and a value is related to r value, therefore the design of r value should be able to guarantee that above-mentioned formula (3) and formula (5) are set up.
In an embodiment of the invention, the material of the tubular body 101 and the leaflet 102 is bovine pericardium, pig Pericardium, horse pericardium, mule pericardium, any one animal pericardium in donkey pericardium.
As shown in figure 9, may comprise steps of the embodiment of the invention provides a kind of method for making valved conduit:
Step 901: according at least one of age, average weight and the average body surface area predefined, determining The radius of tubular body;According to the radius of the tubular body, the first size of sheet noumenon is determined;According to the tubular body Radius and the leaflet number that has predefined, determine the second size of leaflet, the leaflet for including in second size it is upper The length at edge meets above-mentioned formula (1).
Step 902: cutting out and meet the target sheet noumenon of the first size, meet at least the three of second size A target leaflet.
Step 903: respectively by the side edge sewing of each target leaflet on the target sheet noumenon, so that The upper edge of the target leaflet is mutually separated with the target sheet noumenon, between the target leaflet and the target sheet noumenon Form valve pocket.
Step 904: it is handled through at least one layer of side sewing, the target sheet noumenon is sewn into target tubular body, Valved conduit is made, wherein the target leaflet is located at the inside of the target tubular body.
In detail, the size for the valved conduit being applicable in by all ages and classes, weight, body surface area is different, therefore is making When valved conduit, it usually needs make a series of valved conduit of different sizes.Leaflet in different size valved conduit is not to the utmost It is identical.Assuming that each leaflet continuous horizontal in valved conduit is arranged, therefore according to the radius of scheduled tubular body, it can be further Determine the size of sheet noumenon to be cut and the size of leaflet.
Based on above content, in an embodiment of the invention, when the age of valved conduit rated personnel is not more than 2 years old, The diameter of the tubular body is 12mm;
The age of valved conduit rated personnel be 3 years old or 4 years old when, the diameter of the tubular body be located at range [14mm, In 16mm);
When the age of valved conduit rated personnel is 5 years old or 6 years old, the diameter of the tubular body is 16mm;
The age of valved conduit rated personnel be located at range [7 years old, 9 years old] it is interior when, the diameter of the tubular body is located at model Enclose [16mm, 18mm) in;
The age of valved conduit rated personnel be located at range [10 years old, 12 years old] it is interior when, the diameter of the tubular body is 18mm;
The age of valved conduit rated personnel be 13 years old or 14 years old when, the diameter of the tubular body be located at range [20mm, In 22mm);
When the age of valved conduit rated personnel is not less than 15 years old, the diameter of the tubular body is 22mm.
Under normal conditions, the most gap of the mean pulmonary arterial pressure of all ages and classes personnel is little, such as between range Between [12Pa, 18Pa].
In detail, based on any one in age, weight and average body surface area, tubular body can be determined first Radius, and then determine the perimeter of tubular body.
In an embodiment of the invention, the first size of sheet noumenon may include: the length and width of sheet noumenon. The width of sheet noumenon always slightly greater than the perimeter for the tubular body determined, the height of sheet noumenon is typically predetermined Value, or height value corresponding with specific width value.
In an embodiment of the invention, referring to FIG. 7, the second size of leaflet may include: the upper edge of leaflet The length and radius of curvature on the side edge of length and radius of curvature and leaflet.
Fig. 7 provides a kind of leaflet, and there are upper edges and side along two parts for the leaflet.It is arranged along sequence is above provided with side A series of sewing holes of cloth, therefore can correspond to based on the sewing holes to be sewed to leaflet.Upper edge and sheet noumenon phase point From sewing holes that no setting is required.As can be seen that upper edge and side be along all having certain curvature, corresponding to differently curved degree Radius of curvature it is different.
In detail, when each leaflet continuous horizontal is arranged, according to above-mentioned formula (2), a value can be calculated.In this way, being based on a Value, the l value determined should meet above-mentioned formula (1).In addition, the design of l value can also guarantee the effective vent of formed valve pocket Area can satisfy above-mentioned formula (3) and formula (5).
In detail, the other values in the second size can be set on demand.For example, leaflet is sewn on sheet noumenon, and When meeting calculated a value, the radius of curvature of the upper edge of leaflet be should ensure that, the valve pocket of formation is aforesaid way 2, that is, be in water Flat pattern.For another example, the depth of the valve pocket of formation should meet predetermined depth requirement.
In detail, after determining body dimension and leaflet size, corresponding sheet noumenon and leaflet can be cut out, and By leaflet sewing on sheet noumenon.
In an embodiment of the invention, implementation is sewed in order to illustrate a kind of possible leaflet, so, in the step Before rapid 904, further comprise: sewing holes being set in each described target leaflet respectively;In the target sheet noumenon On, sewing holes corresponding with target leaflet described in each are respectively set;
It is described respectively to sew on the side edge of each target leaflet on the target sheet noumenon, comprising: needle Each target leaflet: based on being set in the sewing holes and the target sheet noumenon being arranged in current goal leaflet The sewing holes corresponding with the current goal leaflet set, sequence inserting needle cabling exist current goal leaflet sewing On the target sheet noumenon.
In detail, the sewing processing implementation of leaflet can refer to Fig. 8.Fig. 8 is one that one embodiment of the invention provides Kind sews the schematic diagram of leaflet on sheet noumenon.
In fig. 8, it is provided with one group of side sewing path on sheet noumenon and the leaflet corresponding to 3 leaflets sews rail Mark.Sewing processing is carried out based on side sewing path, sheet noumenon can be sewn into tubulose.
Leaflet sewing path based on setting needs to sew 3 leaflets, and each leaflet is respectively present, therefore can be successively right Each leaflet should be sewed.
In detail, after by leaflet sewing on sheet noumenon, sheet noumenon can be subjected to side sewing processing, so that this Body is changed into tubulose, i.e. tubular body from sheet.Certainly, leaflet should be located at the inside of tubular body.
In conclusion each embodiment of the invention at least has the following beneficial effects:
1, in the embodiment of the present invention, valved conduit include tubular body, sew respectively on the inside of tubular body at least three A leaflet.The upper edge of each leaflet is mutually separated with tubular body, side is connected along with tubular body through sewing, so that shape between the two At valve pocket;The length of the upper edge of leaflet, minimum line of two endpoints of the upper edge based on leaflet on tubular body are long It spends and determines.When valved conduit is connected between right ventricle and lung, valve pocket is open towards lung;When right ventricle is shunk, the right heart Channel of blood flow of the blood through being formed between each leaflet of room output flows to lung;When right ventricle diastole, channel of blood flow is closed so that returning The blood of stream flows into the valve pocket with certain opening area.When therefore, the embodiment of the present invention can alleviate right ventricle diastole Blood backflow problem.
It should be noted that, in this document, such as first and second etc relational terms are used merely to an entity Or operation is distinguished with another entity or operation, is existed without necessarily requiring or implying between these entities or operation Any actual relationship or order.Moreover, the terms "include", "comprise" or its any other variant be intended to it is non- It is exclusive to include, so that the process, method, article or equipment for including a series of elements not only includes those elements, It but also including other elements that are not explicitly listed, or further include solid by this process, method, article or equipment Some elements.In the absence of more restrictions, the element limited by sentence " including a 〃 〃 ", it is not excluded that There is also other identical factors in the process, method, article or apparatus that includes the element.
Those of ordinary skill in the art will appreciate that: realize that all or part of the steps of above method embodiment can pass through The relevant hardware of program instruction is completed, and program above-mentioned can store in computer-readable storage medium, the program When being executed, step including the steps of the foregoing method embodiments is executed;And storage medium above-mentioned includes: ROM, RAM, magnetic disk or light In the various media that can store program code such as disk.
Finally, it should be noted that the foregoing is merely presently preferred embodiments of the present invention, it is merely to illustrate skill of the invention Art scheme, is not intended to limit the scope of the present invention.Any modification for being made all within the spirits and principles of the present invention, Equivalent replacement, improvement etc., are included within the scope of protection of the present invention.

Claims (10)

1. a kind of valved conduit characterized by comprising
Tubular body sews at least three leaflets on the inside of the tubular body respectively;
For any leaflet: the upper edge of the leaflet is mutually separated with the tubular body, the side of the leaflet along with The tubular body is connected through sewing, so as to form valve pocket between the leaflet and the tubular body;The upper edge of the leaflet Length meet formula one;
The formula one includes: a≤l≤(n-1) a;
Wherein, l be the leaflet upper edge length, unit mm, a for the upper edge of the leaflet two endpoints in institute The minimum wire length on tubular body is stated, unit mm, n are the number of at least three leaflet.
2. valved conduit according to claim 1, which is characterized in that
There is at least one layer of side sewing processing on the tubular body;
It is handled through seam-ripping, the tubular body is changed into sheet noumenon;
The length on the bottom edge edge of the sheet noumenon is not less than the perimeter of the tubular body.
3. valved conduit according to claim 1, which is characterized in that
At least three leaflets integral type connection;
Or,
Further include: valve support, the valve support are connected at least three leaflets integral type, to organize integrated limb;
The height on the side edge of the integral type limb is not less than the depth of the valve pocket;
The width on the bottom edge edge of the integral type limb is not less than the perimeter of the tubular body;
The bottom edge edge and each side of the valve support are connected with the tubular body through sewing along equal.
4. valved conduit according to claim 1, which is characterized in that
At least three leaflets horizontal continuity arrangement;
The a meets formula two;
The formula two includes:
Wherein, r is the radius of the tubular body, and unit mm, n are the number of at least three leaflet.
5. valved conduit according to claim 4, which is characterized in that
Including 3 leaflets;
When a=6mm, l=12mm;
When a=10mm, l=15mm;
When a=14mm, l=18mm;
When a=18mm, l=21mm;
When a=23mm, l=24mm.
6. valved conduit according to claim 4, which is characterized in that
When the design of the r is so that the right ventricle of valved conduit connection is shunk, the effective vent area of the valve pocket meets Formula three;
The formula three includes:
Wherein, the effective vent area of the valve pocket, unit mm when s is the right ventricle contraction of valved conduit connection2, k1 For the first default optimized coefficients, and k1>=1, V are the flow of blood when the right ventricle of valved conduit connection is shunk, and unit is mm3/ s, ν are the flow velocity of blood when the right ventricle of valved conduit connection is shunk, unit mm/s.
7. valved conduit according to claim 4, which is characterized in that
So that when the right ventricle diastole of valved conduit connection, the effective vent area of the valve pocket meets for the design of the r Formula four;
The formula four includes:
Wherein, the effective vent area of the valve pocket, unit mm when s ' is the right ventricle diastole of valved conduit connection2, k2 For the second default optimized coefficients, and k2< 1.
8. according to claim 1 to any valved conduit in 7, which is characterized in that
The material of the tubular body and the leaflet is bovine pericardium, Pigs Hearts packet, horse pericardium, mule pericardium, appointing in donkey pericardium It anticipates a kind of animal pericardium.
9. a kind of method for making valved conduit, which is characterized in that according to age, average weight and the average body predefined At least one of surface area determines the radius of tubular body;According to the radius of the tubular body, the of sheet noumenon is determined One size;According to the radius of the tubular body and the leaflet number that has predefined, the second size of leaflet is determined, described the The length of the upper edge for the leaflet for including in two sizes meets formula one;Further include:
S1: at least three target valves for meeting the target sheet noumenon of the first size, meeting second size are cut out Leaf;
S2: respectively by the side of each target leaflet along sewing on the target sheet noumenon, so that the target The upper edge of leaflet is mutually separated with the target sheet noumenon, forms valve between the target leaflet and the target sheet noumenon Pocket;
S3: handling through at least one layer of side sewing, the target sheet noumenon be sewn into target tubular body, band valve is made Pipeline, wherein the target leaflet is located at the inside of the target tubular body;
The formula one includes: a≤l≤(n-1) a;
Wherein, l is the length of the upper edge of the target leaflet, and unit mm, a are two of the upper edge of the target leaflet Minimum wire length of the endpoint on the target tubular body, unit mm, n are of at least three targets leaflet Number.
10. according to the method described in claim 9, it is characterized in that,
Before the S2, further comprise: sewing holes being set in each described target leaflet respectively;In the target patch On shape ontology, sewing holes corresponding with target leaflet described in each are respectively set;
It is described respectively to sew on the side edge of each target leaflet on the target sheet noumenon, comprising: for every One target leaflet: based on what is be arranged in the sewing holes and the target sheet noumenon being arranged in current goal leaflet Sewing holes corresponding with the current goal leaflet, sequence inserting needle cabling sew the current goal leaflet described On target sheet noumenon.
CN201811391631.5A 2018-11-21 2018-11-21 A kind of valved conduit and the method for making valved conduit Pending CN109567979A (en)

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CN112402059A (en) * 2020-10-16 2021-02-26 金仕生物科技(常熟)有限公司 Sewing method of valve and valve leaflet and intervention valve

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US4759759A (en) * 1983-06-23 1988-07-26 Walker David K Bubble heart valve
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RU2332960C1 (en) * 2007-02-26 2008-09-10 Анатолий Захарович Трошин Prosthesis of venous valve
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CN112402059A (en) * 2020-10-16 2021-02-26 金仕生物科技(常熟)有限公司 Sewing method of valve and valve leaflet and intervention valve
CN112402059B (en) * 2020-10-16 2022-04-05 金仕生物科技(常熟)有限公司 Sewing method of valve and valve leaflet and intervention valve

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