Summary of the invention
In view of this, the present invention provides a kind of dilating sacculus and sacculus dilating catheter, be able to suppress aorta blood toLeft ventricle reflux, it is ensured that the effect of balloon expandable valve, and the structure complexity of conduit can also be reduced, it is ensured that conduit leads toThe property crossed.
According to an aspect of the invention, there is provided a kind of dilating sacculus, the dilating sacculus includes having intermediate channelBalloon body and the valve film that is set on the intermediate channel；The valve film stress after-contraction or expansion, so that in describedBetween channel realize one-way conduction.
Optionally, the valve film has a cavity, the end opening closed at one end and another of the cavity；The wherein valveFilm forms closed one end fixed setting, while the valve film forms the one end being open and connect with external agency.
It optionally, is hollow cone, height of the bottom of the cone relative to the cone after the valve film expansionVertically or it is obliquely installed.
Optionally, the valve film be set to the intermediate channel proximally and distally between or the intermediate channelDistally.
Optionally, the material of the valve film is selected from fluoropolymer, polyesters, polyamide, polyvinyl chloride, nylon elasticOne of body, polyurethane elastomer or multiple combinations.
Optionally, be provided with overlay film on the outer surface of the balloon body, the overlay film partly with the balloon bodyOuter surface fitting.
Optionally, the balloon body includes at least three sacculus bodies, at least three sacculus body parallel arrangeds and shapeAt the intermediate channel.
According to another aspect of the present invention, a kind of sacculus dilating catheter, including the dilating sacculus are provided.
Optionally, the sacculus dilating catheter further includes inner tube and outer tube；Said inner tube is inserted into the outer tube, and describedThe section that inner tube stretches out the outer tube is arranged with the dilating sacculus；The institute of one distal end of the dilating sacculus and said inner tubeSection connection is stated, a proximal end of the dilating sacculus is connect with the outer tube and said inner tube.
Optionally, one end of the valve film is fixedly connected with said inner tube and is formed closed end, the other end of the valve filmIt is connect with said inner tube and/or the balloon body and forms open end.
Optionally, the other end of the valve film is connect by more connecting lines with said inner tube and/or the balloon body.
Optionally, the connecting line is connect by hot melt, suture or glue with said inner tube and/or the balloon body.
Optionally, the connecting line is connect by hot melt, suture or glue with the other end of the valve film.
To sum up, the technical solution provided according to the present invention, it is described for dilating sacculus and corresponding sacculus dilating catheterBe formed with an intermediate channel inside dilating sacculus, and be provided with valve film on the intermediate channel, and the valve film stress after-contraction orExpansion, so that the intermediate channel realizes one-way conduction, and then during surgery, when which is placed in human body valve,Blood flow can realize normal circulation by the intermediate channel, so that blood flow is unaffected when expansion valve, becauseThis, which is suitable for unidirectional blood flow channel, especially heart valve.So aortic blood can be inhibited by valve filmLiquid is to left ventricle reflux, to reduce left ventricle capacity and output, the effect of balloon expandable valve is ensured with this.Particularly,The valve film is adapted to without complicated conduit, therefore, reduces the structure complexity of sacculus dilating catheter and in technologyOn be easily achieved, and the overall size of conduit will not be increased, thereby it can be assured that the passability of conduit.
Specific embodiment
To keep the purpose of the present invention, advantages and features clearer, below in conjunction with attached drawing 1a~1e to proposed by the present inventionDilating sacculus and its sacculus dilating catheter are described in further detail.It should be noted that attached drawing is all made of very simplified formAnd non-accurate ratio is used, only for the purpose of facilitating and clarifying the purpose of the embodiments of the invention.
As used in this specification, singular "a", "an" and "the" includes plural reference, unless interiorIn addition appearance explicitly points out outer.It is as used in this specification, term "or" be usually to include the meaning of "and/or" and intoEnforcement, in addition in addition non-content explicitly points out.Term " proximal end " typically refers to one end that counterpart member depends on proximal operator," distal end " refers to the one end of counterpart member far from operator.As used in this specification, term " inside " typically refers toClose to the axis direction of counterpart member, term " outside " typically refers to the axis direction far from counterpart member.
In Percutaneous balloon mitral valvotomy, valve sacculus (i.e. dilating sacculus) is sent by femoral artery, by artificial heartValve is delivered to aortic area opening, to complete artificial valve merging, restores valvular function.Wherein, pass through valve sacculusStenotic lesion is expanded and is dredged, is conducive to the implant procedure of valve bracket, while expanding after aorta petal implantation by valve sacculusThe rear expansion for opening conduit can make aorta petal attaching effect more preferable, and curative effect is more preferably.
Here, dilating sacculus provided by the invention is not limited to aorta petal, can also be other valves in heart,Such as bicuspid valve, tricuspid valve, cusps of pulmonary valve.In addition, can also be vein valve in addition to heart Endovalve.Further, since this hairBright dilating sacculus can be made of multiple sacculus bodies, be relatively large in diameter, so being particularly suitable for aorta petal, and then be described belowIn, the present invention is come with application of the dilating sacculus on aorta petal for example, but should not be in this, as limitation of the invention.
Fig. 1 a is the structural schematic diagram for the sacculus dilating catheter 100 that one embodiment of the invention provides, and Fig. 1 b is shown in Fig. 1 aSacculus dilating catheter 100 along the cross-sectional view of B-B line, Fig. 1 c is sacculus dilating catheter 100 shown in Fig. 1 a along A-A lineCross-sectional view.As shown in Fig. 1 a to Fig. 1 c, the sacculus dilating catheter 100 includes a dilating sacculus 10-1, and the expansion ballCapsule 10-1 includes the balloon body with intermediate channel 9, therefore, when dilating sacculus 10-1 is placed in aorta petal,Blood flow can realize normal circulation by intermediate channel 9.Obviously, in dilating sacculus 10-1 process of expansion, blood flow will notIt is hindered, so can ensure the blood supply of heart duration, the valve surgery operability time is extended with this, improves ballCapsule expands the effect of valve, while using without cooperation pacemaker, simplifies surgical procedure.
Further, in order to avoid blood flow is from aorta to left ventricle reflux, the dilating sacculus 10-1 of the present embodiment further includesOne valve film 7, the valve film 7 are set on intermediate channel 9, for solving the problems, such as that 9 one direction of intermediate channel is connected, even bloodStream can only enter aorta from left ventricle forward stream, and cannot enter left ventricle from aortic regurgitation.
Further, the valve film 7 ensures the folk prescription of intermediate channel 9 by forced contraction or expansion in this present embodimentTo conducting.Specifically: when blood flow enters aorta from left ventricle forward stream, the valve film 7 is impacted by blood flow occurs closure receiptsIt contracts and intermediate channel 9 is made to remain unimpeded；Conversely, the valve film 7 is rushed by blood flow when blood flow enters left ventricle from aortic regurgitationPercussion life is expanded and blocks intermediate channel 9, is passed through with clinopodium polycephalum in this.Medical high polymer material can be selected in the material of the valve film 7Material, such as fluoropolymer, polyesters, polyamide, polyvinyl chloride, nylon elastomer, polyurethanes elastic rubber or two kindsOr both the above material polymer or compound.
In the present embodiment, inhibit aorta blood ventricle reflux to the left by valve film 7, to reduce left ventricle capacityAnd output, the effect of balloon expandable valve is ensured with this.Importantly, completing opening for valve film 7 only by the impact of blood flowIt closes, so that the structure of sacculus dilating catheter can simplify, it is technologically simple to implement, and the overall size of conduit will not be increased,Thereby it can be assured that the passability of conduit.
In order to form intermediate channel 9, the dilating sacculus 10-1 includes at least three sacculus body 10-2, ball shown in figureUtricule 10-2 is six, but not limited to this.At least three sacculus body 10-2 parallel arranged and the formation intermediate channel 9.Here, parallel arranged refers to, the axis of at least three sacculus body 10-2 is arranged in parallel, especially described at least three sacculusThe flat segments 1 of body 10-2 are arranged in parallel.It is in parallel arranged to form in such a way that head and the tail are aligned however, at least three sacculus body 10-2 are unlimitedOne hollow cylinder, the mode parallel arranged that can also be staggered and the internal formation intermediate channel 9.In the present embodiment, instituteIt states at least three sacculus body 10-2 and is preferably in parallel arranged to form a hollow cylinder, to obtain the lesser dilating sacculus of outer dimension10-1。
Further, when the quantity of the sacculus body 10-2 is three or more, in an advantageous embodiment, two each otherIt can be fixed by the way of glue bonding between adjacent sacculus body 10-2, multiple sacculus body 10-2 institute can be made in this wayThe dimensional stability of the dilating sacculus 10-1 of formation, the position sacculus body 10-2 remains unchanged after sacculus is full, can make positioned at centreChannel of blood flow is unaffected.Further, for any one sacculus body 10-2, medical macromolecular materials can be selected, it is such as poly-The mixture or compound of the polymer such as amide, polyester or polymer.In this present embodiment, the sacculus body 10-2 canUsing existing structure, use cost is reduced with this.
Preferably, the dilating sacculus 10-1 further includes an overlay film 6, which is set to the outer surface of balloon bodyOn, and can be partly bonded with the outer surface of balloon body so that when balloon expandable, the overlay film 6 can directly with it is intravascularWall is contacted, since overlay film 6 can be preferably bonded with blood vessel, balloon expandable valve can be enhancedEffect.It is noted that the overlay film 6 can also play constraint styling to sacculus, the sacculus after making expansion will not be sent outChange shape, and sacculus adaptability is higher, promotes the effect of balloon expandable valve.
It is furthermore preferred that the intensity of the overlay film 6 is higher than intensity (such as tensile strength, bending resistance of any one sacculus body 10-2Intensity, yield strength etc.), to enhance dilating sacculus 10-1 in resistance to the puncturing property of calcific aortic valve lesion, it is resistance to promote sacculusCompliance is pressed and reduces, to enhance balloon expandable power.It, can be by selecting different material or different in practical operationMolding mode, so that the intensity of overlay film 6 is higher than the intensity of any one sacculus body 10-2.
In one embodiment, the sacculus body 10-2 is made of Nylon12, and the overlay film 6 can select PET material.Wherein the tensile strength of Nylon12 can be selected between 138Mpa~275Mpa, bending strength can be selected in 90Mpa~214Mpa itBetween；Tensile strength >=275MPa of PET, bending strength is between 148MPa-310Mpa.
When the intensity of the overlay film 6 is higher than the intensity of any one sacculus body 10-2, overlay film 6 can be reduced as far as possibleThickness, to reduce the profile after dilating sacculus pressure is held (profile size).With coronary artery, peripheral blood vessel and body, there are for the blood vessel of calcification stenotic lesion, the thickness limit of the overlay film 6 is 0.01mm~0.15mm for other.
In one embodiment, the material selection medical macromolecular materials of the overlay film 6, more preferable polymer material, such asOne kind of polyesters, polyamide, polyethylene kind, fluoropolymer etc. or the multiple combinations of these materials.It is non-limiting, the overlay film 6 is realized by film forming technique, or by knitting forming, is also possible to the composite construction of film and braiding.Existing thin polymer film can be fixed on the sacculus outer surface after pressurising expansion by glue by the overlay film 6 of membrane structure.GlueEpoxy glue, polyurethane adhesive, optic-solidified adhesive and the silica gel of biocompatibility can be used in water.The overlay film of braiding structure can pass through glueOverlay film is fixed on sacculus body surface face by the modes such as water or suture.
Preferably, hydrophilic coating can be coated on the overlay film 6, to promote the passability of sacculus in the blood vessel.Generally, may be usedSelect the hydrophilic materials such as polyvinylpyrrolidone (PVP), polyvinyl alcohol (PAA), polyacrylic acid (PAA), polyethylene glycol (PEG)Material.
In turn, in one embodiment, as shown in Figure 1 b, the valve film 7 may be disposed at intermediate channel 9 proximally and distallyBetween；Alternatively, in another embodiment, as shown in Figure 1 d, the valve film 7 may also be disposed on the distal end of intermediate channel 9, and oneThe distal end of the also extended intermediate channel 9 in part；Or the valve film 7 may also set up in the proximal end of intermediate channel 9, but considerTo the particular configuration of valve film 7, the valve film 7 is generally entirely located in intermediate channel 9, is made with preferably playing to block in structureWith.So the valve film 7 can be located at the different location on intermediate channel 9.But unlimited setting one on the intermediate channel 9Multiple valve films 7 can also be arranged in valve film 7, and multiple valve films 7 are arranged along the axially spaced-apart of intermediate channel 9, can be used as Redundancy Design,So that it is guaranteed that the reliability of actual use.
Furthermore, it is understood that the valve film 7 can have a cavity, and the formation closed end closed at one end of the cavity and correspondenceIn the distal end of dilating sacculus 10-1, and the other end of the cavity is open to form open end and corresponding to the close of dilating sacculus 10-1End, here, the closed end is fixedly installed, for being bonded with intermediate channel 9 after the open end expansion.When the valve film 7When the open end is bonded with intermediate channel 9, the intermediate channel 9 is blocked；When the open end of the valve film 7 occursWhen contraction, the intermediate channel 9 is released from closure.Obviously, the size of the open end is greater than or equal to having for intermediate channel 9Imitate size.Here, the effective dimensions of the intermediate channel 9, refers on the intermediate channel 9 for fitting with the open endCavity diameter at position.For example, when the cross-sectional shape of the intermediate channel 9 is, for example, " star " shown in Fig. 1 c,The cross sectional shape of the open end of the valve film 7 can be matched or be mismatched with " star " is somebody's turn to do, but the section ruler of the open endIt is very little at least with " star " unanimously leaked so that the section of open end and intermediate channel 9 effectively be bonded without will cause.
Fig. 1 e is the structural schematic diagram for the valve film 7 that one embodiment of the invention provides, and as shown in fig. le, the valve film 7 can be withFor a hollow cone, but it is not limited to the cone of diagram, as long as forming inner hollow and an end seal shown in similar Fig. 1 eClose the structure of another end opening.For cone, the bottom of the cone can be perpendicular relative to its short transverseOr non-perpendicular setting, i.e. bottom also tiltable.In practice, the edge of the bottom of the cone is used to attach with intermediate channel 9,Such as the inner wall of intermediate channel 9 that the flat segments 1 of the edge of the bottom of the cone and each sacculus body 10-2 are surrounded byIt attaches, while needing to be fixedly installed at the top of the cone, to ensure that valve film 7 will not move.
It may include flat segments 1, nearly pipeline section 2 and remote pipe for any one sacculus body 10-2 as shown in Fig. 1 b or Fig. 1 dSection 3, the flat segments 1 are located between nearly pipeline section 2 and remote pipeline section 3, and the cross sectional dimensions of the nearly pipeline section 2 is less than flat segments 1Cross sectional dimensions.The shape of the flat segments 1 is cylinder on the whole, and further, the flat segments 1 can also include being located atThe conical section (major diameter of conical section is connect with intermediate cylindrical section) at both ends.Wherein, in this present embodiment, the nearly pipeline section 2 is rightClose to the direction of doctor or operator, the remote pipeline section 3 corresponds to far from doctor or close to the direction of patient Ying Yu.
The sacculus dilating catheter 100 further includes outer tube 4 and inner tube 5, the nearly pipeline section 2 for simultaneously with outer tube 4 and interiorPipe 5 is tightly connected, and the remote pipeline section 3 is used to be tightly connected with inner tube 5.Actual, said inner tube 5 passes through outer tube 4, and described interiorThe section that pipe 5 stretches out outer tube 4 is provided with dilating sacculus 10-1.When assembly, 2 one side of nearly pipeline section of all sacculus body 10-2 with it is outerThe distal seal of pipe 4 connects, and is on the other hand tightly connected with inner tube 5.For specifically, the proximal end of the nearly pipeline section 2 can be insertedEnter in the gap between inner tube 5 and outer tube 4, to be tightly connected with the outer wall of inner tube 5 and the inner wall of outer tube 4.It will be appreciated thatThe nearly pipeline section 2 can also be not inserted into the gap between inner tube 5 and outer tube 4, but connect with the distal seal of outer tube 4.
Optionally, the nearly pipeline section 2 is connect by modes such as glue, hot melts with inner tube 5 and outer tube 4, it is preferable that all is closePipeline section 2 is summarized in the same axial position in inner tube 5.Further, the remote pipeline section 3 of all sacculus body 10-2 and inner tube 5 are stretched out outerThe section of pipe 4 is connected and sealed.Optionally, the remote pipeline section 3 is tightly connected by the modes such as glue, hot melt and inner tube 5.It is excellentChoosing, all remote pipeline sections 3 are also summarized in the same axial position in inner tube 5 (axial position is close to the distal end of inner tube 5).
And then when practical application, for any one sacculus body 10-2, the inner cavity of nearly pipeline section 2 and outer tube 4 and interiorGap between pipe 5 is connected, and allows full medium by the gap between inner tube 5 and outer tube 4, and via nearly pipeline section 2The full of flat segments 1 is realized into flat segments 1.The dilating sacculus 10-1 of the present embodiment forms both ends on the whole as a result,Tapered conduit part and it is located in the middle sacculus portion, wherein being located at a conduit part of catheter proximal end for providing full mediumCirculation passage, and another conduit part for being located at distal end can form plugging structure, wherein one conduit part is by multiple closePipeline section 2 limits, another described conduit part is limited by multiple remote pipeline sections 3, in addition, the sacculus portion is by multiple sacculus1 parallel arranged of flat segments of body 10-2 forms, so that the working region of dilating sacculus 10-1 is constituted, outside the part of the working regionSurface with the vascular wall of aorta petal for being bonded.In this way, compared to the dilating sacculus that single sacculus body is constituted, the present embodimentDilating sacculus 10-1 not only will not influence when expanding valve blood flow circulation, moreover it is possible to design larger-sized sacculus, meetThe needs of difference treatment.
With continued reference to Fig. 1 e, the closed end of the valve film 7 can be fixed with inner tube 5, but fixed position is not limited to expansion ballCapsule 10-1's is internal or external.In addition, the open end of the valve film 7 preferably passes through more connecting lines 8 and inner tube 5 or dilating sacculus10-1 connection.The material of the connecting line 8 can be selected from polymer fiber, and intensity is good.
For example, one end of the more connecting lines 8 is connect with the edge of the open end of valve film 7, connection type be can be selectedGlue bonding, hot-melt adhesive paste or suture are fixed, preferably hot if the connecting line 8 is close or identical with the material melting point of valve film 7Molten connection.The other end of more connecting lines 8 is connect with inner tube 5, and it is solid that glue bonding, hot-melt adhesive paste or suture can be selected in connection typeIt is fixed, if connecting line 8 is close or identical with the material melting point of inner tube 5, preferred hot-melt adhesive paste.However, the connecting line 8 is anotherEnd also can be connected to flat segments 1 or other positions of sacculus body 10-2, such as be bonded to flat segments 1 by glue.Alternatively, the companyThe other end of wiring 8 can both connect inner tube 5, can also connect balloon body simultaneously.
Finally, need to supplement, tapering angle, opening size and the length of the valve film 7 and the quantity of connecting line 8It can be configured according to practical sacculus specification with length, the present invention does not limit this particularly.
To sum up, the technical solution provided according to embodiments of the present invention is led for dilating sacculus and corresponding balloon expandablePipe, the inside of the dilating sacculus is formed with an intermediate channel, and valve film is provided on the intermediate channel, and the valve film stressThe dilating sacculus so that the intermediate channel realizes one-way conduction, and then during surgery, is placed in human body by after-contraction or expansionWhen valve, blood flow can realize normal circulation by the intermediate channel, so that blood flow not will receive when expansion valveIt influences, therefore, which is suitable for unidirectional blood flow channel, especially heart valve.So can inhibit main by valve filmArterial blood is to left ventricle reflux, to reduce left ventricle capacity and output, the effect of balloon expandable valve is ensured with this.It is specialOther, which is adapted to without complicated conduit, therefore, reduce the structure complexity of sacculus dilating catheter andIt is technologically simple to implement, and the overall size of conduit will not be increased, thereby it can be assured that the passability of conduit.
Foregoing description is only the description to present pre-ferred embodiments, not to any restriction of the scope of the invention, this hairAny change, the modification that the those of ordinary skill in bright field does according to the disclosure above content, belong to the protection of claimsRange.