Background technology
The heart of human body has four cardiac valves：Bicuspid valve, tricuspid valve, aorta petal and pulmonary valve.With bicuspid valveExemplified by, bicuspid valve is between atrium sinistrum and left ventricle, and by the double leaf knot of the separated connective tissue in atrium sinistrum and left ventricleStructure, including annulus, be connected to the frontal lobe of annulus leading portion and be connected to the rear leaf of annulus back segment.Bicuspid valve plays an one-way cockEffect, during a cardiac cycle, during left atrium contracts, mitral valve open, blood flows to left ventricle by atrium sinistrum；WhenDuring left ventricular contraction, mitral valve closure, blood is from left ventricle pump to sustainer, then flow to each organ of whole body.
When lesion occurs in bicuspid valve, such as mitral annulus expands, and can cause when left room is shunk, before bicuspid valveLeaf and rear leaf can not completely close, and part blood can flow to atrium sinistrum by bicuspid valve, the phenomenon of this backflow of blood, be referred to asMitral reflux.Mitral reflux may decline cardiac output and LVEF, so as to LV Diastolic end of term capacity andPressure substantially increases, and patient may occur in which pulmonary hypertension and heart failure, ultimately results in death.
Common treatment method for mitral reflux is valve reparation plasty.Surgeon is circulated down in vitro, repaiiesImpaired cardiac valves form again, the annulus of expansion is corrected, so as to treat mitral reflux.In order to keep long-term treatment to imitateFruit, after valve reparation plasty, surgeon is often implanted into an artificial valve forming ring in the annulus position of patient, withEnsure the good moulding of autologous annulus, while prevent annulus from further expanding, with maintaining treatment effect.
Existing artificial valve forming ring has a three-decker, and innermost layer is metal or high polymer material supporter, middleLayer is silica gel, and outermost layer is woven dacron, and the supporter of wherein innermost layer primarily serves effectively moulding effect.Clinically applyArtificial valve forming ring is divided into three types from rigidity：Hard forming ring, semi-rigid forming ring and soft forming ring.Hard intoThe innermost layer of shape ring is typically using the very big metal material of rigidity, such as titanium alloy, is not susceptible to deform during by external force.Hard shapesAlthough ring serves good moulding effect to autologous annulus, the motion of autologous annulus is limited, in systoleIn, the size of autologous annulus can change with the contraction of heart, when the motion of autologous annulus is restricted, left ventricleFunction can be affected.The innermost layer of soft forming ring typically uses high molecular polymer as supporter, although in heartSoft forming ring easily deforms in contraction process, does not influence the motion of autologous annulus, but soft forming ring is excessively soft,The effectively moulding requirement of autologous annulus can not be met.Semi-rigid forming ring combines the excellent of hard forming ring and soft forming ringPoint, can be well moulding by the rigidity forming ring for adjusting supporter, and and can adapts to the change of annulus size during heart contractionChange, attract attention more and more.
Metal wire material or the multiple different number of plies of the supporter of existing semi-rigid forming ring typically using more variable diametersMetal sheet be superimposed to be formed, adjust supporter rigidity by adjusting wire diameter, sheet thickness or the superposition number of plies.UsingSemi-rigid forming ring prepared by this method, processing is very cumbersome, and complex process, technical difficulty are high.
The content of the invention
Based on this, it is necessary to which offer one kind is simple in construction, prepares convenient valve forming ring.
The present invention provides a kind of valve forming ring, including the support ring being bent to form by support tube and is coated on the supportStitching floor on ring outer peripheral face, at least one hollow-out unit is offered in the curved interior of the support ring.
In one of the embodiments, the support ring include leading portion, back segment, left section, right section and connect each section of companySocket part, any one rigidity is respectively less than the rigidity of the leading portion in the back segment, left section and right section.
In one of the embodiments, the valve forming ring also includes connector, two free ends of the support tubeIt is fixedly connected by the connector.
In one of the embodiments, the external diameter at the both ends of the connector is respectively less than two free ends of the support tubeInternal diameter, the both ends of the connector insert the support tube from two free ends of the support tube respectively, and with the branchTwo free ends of stay tube are fixedly connected.
In one of the embodiments, the hollow out rate of the support ring is more than or equal to 10%, and less than or equal to 50%.
In one of the embodiments, the hollow out rate of the support ring is 33.5%.
In one of the embodiments, adjacent two side of the hollow-out unit is connected by circular arc.
In one of the embodiments, middle part of the hollow-out unit along support ring circumference is in the support ringLength on axial direction, less than the hollow-out unit along at least one end in the circumferential both ends of the support ring in the supportThe upward length of annulate shaft.
In one of the embodiments, maximum length of the hollow-out unit on the support ring axial direction is less than 2mm, andMore than 1mm；Minimum length of the hollow-out unit on the support ring axial direction is less than 1mm, and is more than 0.5mm.
In one of the embodiments, the valve forming ring also includes layer of silica gel, and the stitching floor coats the silica gelLayer, the layer of silica gel is in hollow tubular, is sheathed on the outer peripheral face of the support ring, or the layer of silica gel fills the supportThe inner chamber of ring and it is covered on the outer peripheral face of the support ring.
In one of the embodiments, the valve forming ring also includes the ring body from the valve forming ring described inThe sutural margin of the outside extension of valve forming ring.
In one of the embodiments, the layer of silica gel is included outside from the body of the layer of silica gel towards the support ringThe flange of side extension, the flange are step-like or protrusion arcuation.
The valve forming ring of the present invention, by opening up hollow-out unit in the curved interior of support ring, to the firm of support ringDegree is adjusted, so as to obtain the valve forming ring of semi-rigid；And can by the way that the hollow out rate of support ring is adjusted, fromAnd the rigidity of support ring is adjusted, and then the rigidity of valve forming ring is met the psychological need of different autologous annulus, becauseThis, valve forming ring of the invention processing is simple, it is convenient to prepare.
Embodiment
In order to make the purpose , technical scheme and advantage of the present invention be clearer, it is right below in conjunction with drawings and ExamplesThe present invention is further elaborated.It should be appreciated that the specific embodiments described herein are merely illustrative of the present invention, andIt is not used in the restriction present invention.
It should be noted that working as two elements is referred to as " being fixedly connected ", it can refer to that two elements are directly fixedly connected,It may also mean that two elements are fixedly connected by centering elements.
The present invention provides a kind of valve forming ring, for repairing impaired cardiac valves form, for example corrects the valve of expansionThe illnesss such as ring, valve prolapse.The cardiac valves includes the valves such as bicuspid valve, tricuspid valve, aorta petal and pulmonary valve.This realityApply in mode, the shape and structure of the valve forming ring of the present invention are described in detail only for bicuspid valve, it is to be understood that thisThe structure of the valve forming ring of invention can be also used in other cardiac valves such as tricuspid valve, aorta petal and pulmonary valve, onlyNeed the shape of valve forming ring being designed to comply with the physiology and appearance of tricuspid valve, aorta petal and pulmonary valve.Therefore,No longer to the shape for other valvular valve forming rings such as tricuspid valve, aorta petal and pulmonary valve in present embodimentShape is repeated.
In valve forming ring technical field, the lower end that blood flow flows to valve forming ring from the upper end of valve forming ring is defined.
Fig. 1 and Fig. 2 are referred to, valve forming ring 100 of the invention is used to correct mitral annulus expansion, present embodimentIn, in order to adapt to the physiology and appearance of mitral annulus, valve forming ring 100 is the three-dimensional saddle-shaped ring of closing, including preceding ring segment101st, the linkage section 105 between rear ring segment 102, left ring segment 103, right ring segment 104 and each ring segment of connection.The three-dimensional saddle-shaped ringRefer to, preceding ring segment 101 and rear ring segment 102 are raised towards the lower end of valve forming ring 100, and left ring segment 103 and right ring segment 104 are equalThree-dimensional loop structure is formed after towards the upper end projection of valve forming ring 100.
It is appreciated that valve forming ring 100 can also be open loop structure, or plane or other irregular shapes,Only need valve forming ring 100 to be sutured with mitral annulus, and then correct mitral annulus.
Referring to Fig. 3, valve forming ring 100 includes support ring 10 and the stitching floor being coated on the outer peripheral face of support ring 1030, wherein, support ring 10 is used to make valve forming ring 100 form above-mentioned three-dimensional saddle type ring structure；Stitching floor 30 is used to supply suture(not shown) passes through, and is sutured by the suture with mitral annulus.
Stitching floor 30 is tissue layer, and for facilitating suture to sew up and stitching out, stitching floor 30 is prepared by biocompatible materialsForm, stitching floor 30 is preferably prepared using terylene in the present invention.
Referring to Fig. 4, in the present invention, it is each that support ring 10 includes leading portion 11, back segment 12, left section 13, right section 14 and connectionThe connecting portion 15 of section, correspond respectively to preceding ring segment 101, rear ring segment 102, left ring segment 103, the right ring segment 104 of valve forming ring 100And linkage section 105, wherein leading portion 11 and back segment 12 is raised towards the lower end of valve forming ring 100, left section 13 and right section 14It is raised towards the upper end of valve forming ring 100, so that the valve forming ring 100 with support ring 10 forms three-dimensional saddle-shaped ringStructure.
Support ring 10 is bent to form by support tube, and the support tube can be stainless steel, nickel cobalt (alloy), titanium alloy, NiTiThe rigid pipes such as alloy.In the present invention, " rigidity " refers to valve forming ring 100 and after mitral annulus suture, support ring 10 canOriginal three-dimensional saddle shapes are kept without being deformed.In present embodiment, the support tube is preferably Nitinol pipe, toolBody, the Nitinol pipe is bent into required shape first, then carried out Nitinol pipe after bending at high warmReason setting, be supported ring 10.The support tube in bending, the side face of the curved interior of the support tube by compression,The side face of the curved outside of the support tube is by tension.
Referring to Fig. 5, in the present invention, valve forming ring 100 also includes connector 16, for by the both ends phase of support ring 10Even.Connector 16 is metal solid bar or metal pipe material, and the both ends external diameter of connector 16 is respectively less than two of support ring 10The internal diameter of free end.The inner chamber of support ring 10 is inserted at the both ends of connector 16 from two free ends of support ring 10 respectively, is being propped upTwo free ends of pushing out ring 10 carry out laser welding with the overlapping region of connector 16, pass through two free ends of support ring 10Connector 16 is fixedly connected, so as to which support ring 10 turns into an enclosed ring.It is appreciated that connector 16 can also beBoth ends internal diameter is all higher than the metal pipe material of the external diameter of two free ends of support ring 10, now, support ring 10 two at free endThe inner chamber of connector 16 is inserted from the both ends of connector 16 respectively, is entered at the both ends of connector 16 and the overlapping region of support ring 10Row laser welding, two free ends of support ring 10 are made to be fixedly connected by connector 16.It is appreciated that in order that supportRing 10 forms enclosed ring, can save connector 16, and two free ends of support ring 10 are made into by bonding, riveting, coveringConnect or the other modes such as directly weld and be fixedly connected.
It is appreciated that the support ring 10 in valve forming ring 100 can also be open loop structure, i.e. in valve forming ring 100The both ends of support ring 10 be separated, and do not lead to fitting 16, bonding, riveting, socket or the direct other modes such as weld and be connected,Now stitching floor 30 is coated on the outside of support tube 10, and the both ends of stitching floor 30 are sutured to form the valve forming of closed circularRing 100.
Referring to Fig. 4, at least one hollow-out unit 17 is offered in the curved interior of support ring 10.Need what is illustratedIt is, when such as the factor such as the caliber of support ring 10, pipe thickness or tubing determines the other factorses of the influence rigidity of support ring 10,By being adjusted to the hollow out rate of support ring 10, it is possible to achieve the rigidity of support ring 10 is adjusted.In the present invention, supportThe hollow out rate of ring 10 refers to that the fretwork area of whole hollow-out units 17, which accounts for, on the outer peripheral face of the curved interior of support ring 10 does not open upThe percentage of the whole outer circumferential area of the front support ring 10 of hollow-out unit 17；Similarly, each section of hollow out rate of support ring 10 is to refer to phaseAnswer whole hollow-out units 17 on the outer peripheral face of the curved interior of section fretwork area account for it is corresponding before not opening up hollow-out unit 17The percentage of the whole outer circumferential area of section.Hollow out rate can pass through the quantity of hollow-out unit 17 and engraving for each hollow-out unit 17Empty area is adjusted, it will be understood that the fretwork area of multiple hollow-out units 17 can with it is equal can also be unequal, multiple hollow outsThe shape of unit 17 can be the same or different.In the present invention, the hollow out rate of support ring 10 is more than or equal to 10%, and is less thanOr equal to 50%.Further, the hollow out rate of support ring 10 is preferably 33.5%.
In the present invention, support ring 10 includes multiple hollow-out units 17, and multiple hollow-out units 17 are in the back segment of support ring 1012nd, uniform intervals are distributed in left section 13 and right section 14 of curved interior, because the connection of connector 16 and support ring 10 is positioned at branchAt the leading portion 11 of pushing out ring 10, thus the leading portion 11 of support ring 10 have compared to back segment 12, left section 13 or right section 14 it is higher firmDegree.After valve forming ring 100 is implanted into mitral annulus, with the change of mitral annulus caused by heart contraction and diastole,The deformation force that valve forming ring 100 can be brought by mitral annulus, now, because the leading portion 11 of support ring 10 is with higherRigidity, so as to ensure that the connective stability of the support ring 10 being attached at leading portion 11 and connector 16, avoid supportRing 10 and connector 16 produce separation because of the deformation force.It is appreciated that multiple hollow-out units 17 can also be in support ringIn 10 curved interior non-uniform spacing be distributed, now multiple sections of hollow out rate of support ring 10 can with it is equal can not also phaseDeng multiple sections of rigidity of i.e. support tube 10 can be adjusted to equal or unequal, to adapt to the life of different mitral annulusesReason demand.
The valve forming ring 100 of the present invention, support ring 10 is prepared using rigid tubing, and by the curved of support ring 10Hollow-out unit 17 is opened up on bent inner side, the rigidity of support ring 10 is adjusted, so as to obtain the valve forming ring of semi-rigid100.Furthermore, it is possible to by being adjusted to the hollow out rate of support ring 10, to adjust the rigidity of support ring 10, and then valve is adjustedThe rigidity of forming ring 100 is to meet the psychological need of different mitral annuluses, and processing is simple, it is convenient to prepare.And the present inventionValve forming ring 100 in, hollow-out unit 17 is all opened in the curved interior of support ring 10, in the rigidity to support ring 10While being adjusted, it is thus also avoided that the bending of the risk, i.e. support ring 10 of the outer peripheral face cracking of the curved outside of support ring 10Outside is used for the rigidity for ensureing support ring 10, hollow-out unit 17 is opened up in the curved interior of support ring 10, for adjusting support ring10 rigidity.
It is appreciated that valve forming ring 100 can also include layer of silica gel, referring to Fig. 6, layer of silica gel 20 is sheathed on support ringOn 10, and between support ring 10 and stitching floor 30.Layer of silica gel 20 in hollow tubular and on the outer peripheral face of upper end formed withFlange 21.Flange 21 extends from the body of layer of silica gel 20 towards the outside of support ring 10, is formed step-like.Stitching floor 30 is covered inOn the outer peripheral face and flange 21 of layer of silica gel 20, so as to form sutural margin 31, now, sutural margin 31 at the flange 21 of layer of silica gel 20Shape it is identical with the shape of flange 21, sutural margin 31 is from the ring body of valve forming ring 100 towards the outside of valve forming ring 100Extension.Sutural margin 31 is used to be sutured valve forming ring 100 with mitral annulus for suture.Due to the flange of layer of silica gel 2021 extend towards the outside of support ring 10, make sutural margin 31 away from support ring 10, so as to which suture is sewed up or stitched at sutural margin 31When going out, it efficiently avoid the suture and encounter support ring 10 and drive support ring 10 to move or suture failure, and then reduceValve forming ring 100 shifts or sutured the possibility of failure, improves the security and validity of operation.
It is appreciated that the flange 21 of layer of silica gel 20 can not also be step-like, referring to Fig. 7, the remote branch of layer of silica gel 20The thickness of other side walls of the thickness ratio layer of silica gel 20 of the side wall of the inner side of pushing out ring 10 is thick, i.e., in the remote support ring 10 of layer of silica gel 20The side wall of side is protrusion arcuation, forms flange 21.Now, sutural margin 31 is also protrusion arcuation.
It is appreciated that layer of silica gel 20 can not also include flange 21, now stitching floor 30 is covered in the periphery of layer of silica gel 20On face, because the tube wall of layer of silica gel 20 has a certain thickness, therefore suture is when sewing up or stitching out stitching floor 30 and layer of silica gel 20,Suture a certain degree of can also be avoided to encounter support ring 10 and drive support ring 10 to move or suture failure, and then reducedValve forming ring 100 shifts or sutured the possibility of failure, improves the security and validity of operation.
It is appreciated that the shape of the layer of silica gel is not restricted to hollow tubular, referring to Fig. 8, layer of silica gel 20 can also fill outFill in the inner chamber of support ring 10 and be covered on the outer peripheral face of support ring 10.Now, because layer of silica gel 20 is filled with support ring10 inner chamber, so as to eliminate the air in the inner chamber of support ring 10, after avoiding the implantation mitral annulus of valve forming ring 100,Air in support ring 10 subsequently discharges, and influences the shape of valve forming ring 100, or even produce harm to health.
Now, layer of silica gel 20 is except that can make suture preferably be sutured valve forming ring 100 with mitral annulusOutside, after valve forming ring 100 is implanted into mitral annulus, with the change of mitral annulus caused by heart contraction and diastole,The deformation force that valve forming ring 100 can be brought by mitral annulus, now, layer of silica gel 20 can also play to the deformation forceThe effect of buffering, to reduce influence of the deformation force to support ring 10.
In the present invention, layer of silica gel 20 is injected using liquid-state silicon gel, so as to be integrally formed with support ring 10.First, will supportRing 10 is positioned in mould；Then, liquid-state silicon gel is injected into dies cavity, the liquid-state silicon gel is filled under the effect of the pressureIn the outside or outside and inner chamber of support ring 10；Finally, the mould is heated, makes liquid-state silicon gel curing molding, take out oneBody formed layer of silica gel 20 and support ring 10.When the deformation force that valve forming ring 100 is brought by mitral annulus, due to siliconGlue-line 20 is integrally formed with support ring 10, and layer of silica gel 20 can preferably buffer to the deformation force, so as to preferably reduce instituteState influence of the deformation force to support ring 10.It is meanwhile very close to each other between layer of silica gel 20 and support ring 10, it is ensured that valve formingAfter ring 100 is implanted into mitral annulus, with heart contraction and diastole, avoids support ring 10 and produce movement relative to layer of silica gel 20,Because layer of silica gel 20 is stitched together with mitral annulus, that is to say, that avoid support ring 10 and produced with respect to mitral annulusIt is mobile, that is, it ensure that rectification effect of the valve forming ring 100 to mitral annulus.
It is appreciated that when layer of silica gel 20 is only sheathed on the outer peripheral face of support ring 10, layer of silica gel 20 can not also be with supportRing 10 is fixedly connected, i.e. and the separately formed acceptable elder generation of layer of silica gel 20 is tubulose, then is sheathed on the outer peripheral face of support ring 10, fromAnd make the preparation of valve forming ring 100 easy, it is cost-effective.
Referring to Fig. 9, it cuts for the support ring 10 of the present invention in its curved outside along the direction parallel to central axisThe partial schematic plan view deployed after opening.Being generally shaped like for hollow-out unit 17 is I-shaped, including the axial phase along support ring 10To the first side 171 and second side 172 of distribution, and the He of the 3rd side 173 of the circumferentially opposed distribution along support ring 10Four side 174.Each two is adjacent in first side 171, second side 172, the 3rd side 173 and four side 174Side is connected by circular arc；3rd side 173 and four side 174 are respectively facing other side's depression, to form substantially I-shapedThe hollow-out unit 17 of shape.In the present invention, because the 3rd side 173 and four side 174 are respectively facing other side's depression, so as to lowerStitching floor 30 or stitching floor 30 and layer of silica gel 20 produce the possibility that large area collapses at hollow-out unit 17, improve valveThe stability of the configuration of surface of forming ring.
It is appreciated that the shape of hollow-out unit 17 is not limited to I-shaped, can also be the 3rd side 173 and four sideOnly one side in 174 is directed towards the generally U-shaped of depression, or wide along 10 circumferential both ends of support ring and middle narrow waist drumThe other shapes such as shape, hollow-out unit 17 is only needed to be less than along length of the circumferential middle part of support ring 10 on the axial direction of support ring 10Its length along at least one end in the circumferential both ends of support ring 10 on the axial direction of support ring 10.Need what is illustratedIt is that " middle part " refers to hollow-out unit 17 along any position behind the circumferential removing both ends of support ring 10.
In the present invention, maximum length of the hollow-out unit 17 on the axial direction of support ring 10 is less than 2mm, and is more than 1mm；Hollow out listFirst 17 minimum length on the axial direction of support ring 10 is less than 1mm, and is more than 0.5mm.Now, hollow-out unit 17 is in adjustment support ringWhile 10 rigidity, moreover it is possible to ensure the stability of the configuration of surface of valve forming ring.
It is appreciated that referring to Fig. 10, in other embodiment, hollow-out unit 17a can also be the big of foursquare arc transitionCause square, can not only reduce the rigidity of support ring 10, it is thus also avoided that support ring 10 is produced in hollow-out unit 17a side junctionRaw stress concentration, and then avoid support ring 10 and produce fracture in hollow-out unit 17a side junction.The foursquare arc mistakeCross and refer to, the adjacent both sides of square structure are connected by circular arc.
It is appreciated that can also by adjust spacing or multiple hollow-out units between multiple hollow-out units shape,Or multiple hollow-out units are along other modes such as the length on the axial direction of support ring 10, i.e., by adjusting the diverse location of support ring 10Hollow out rate, the rigidity of the diverse location of support ring 10 is adjusted, to meet the psychological need of different mitral annuluses.It please joinRead Figure 11, in other embodiment, maximum lengths of multiple hollow-out unit 17b in the circumference of support ring 10 is unequal, so as to adjustThe rigidity of support ring 10, realizing the diverse location of support ring 10 has different-stiffness, to meet the physiology of different mitral annulusesDemand.
Each technical characteristic of embodiment described above can be combined arbitrarily, to make description succinct, not to above-mentioned realityApply all possible combination of each technical characteristic in example to be all described, as long as however, the combination of these technical characteristics is not depositedIn contradiction, the scope that this specification is recorded all is considered to be.
Embodiment described above only expresses the several embodiments of the present invention, and its description is more specific and detailed, but simultaneouslyCan not therefore it be construed as limiting the scope of the patent.It should be pointed out that come for one of ordinary skill in the artSay, without departing from the inventive concept of the premise, various modifications and improvements can be made, these belong to the protection of the present inventionScope.Therefore, the protection domain of patent of the present invention should be determined by the appended claims.