CN110123489A - Dilating sacculus and sacculus dilating catheter - Google Patents

Dilating sacculus and sacculus dilating catheter Download PDF

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Publication number
CN110123489A
CN110123489A CN201810108074.5A CN201810108074A CN110123489A CN 110123489 A CN110123489 A CN 110123489A CN 201810108074 A CN201810108074 A CN 201810108074A CN 110123489 A CN110123489 A CN 110123489A
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China
Prior art keywords
sacculus
dilating
valve film
inner tube
valve
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CN201810108074.5A
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Chinese (zh)
Inventor
刘琛
姚映忠
岳斌
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Shanghai Minimally Invasive Xintong Medical Technology Co Ltd
Shanghai Microport Cardioflow Medtech Co Ltd
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Shanghai Minimally Invasive Xintong Medical Technology Co Ltd
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Priority to CN201810108074.5A priority Critical patent/CN110123489A/en
Priority to PCT/CN2019/073471 priority patent/WO2019149173A1/en
Publication of CN110123489A publication Critical patent/CN110123489A/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
    • A61F2/24Heart 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
    • A61F2/2427Devices for manipulating or deploying heart valves during implantation
    • A61F2/243Deployment by mechanical expansion
    • A61F2/2433Deployment by mechanical expansion using balloon catheter
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M25/1011Multiple balloon catheters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00743Type of operation; Specification of treatment sites
    • A61B2017/00778Operations on blood vessels
    • A61B2017/00783Valvuloplasty

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  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Animal Behavior & Ethology (AREA)
  • Cardiology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Biomedical Technology (AREA)
  • General Health & Medical Sciences (AREA)
  • Biophysics (AREA)
  • Child & Adolescent Psychology (AREA)
  • Pulmonology (AREA)
  • Anesthesiology (AREA)
  • Hematology (AREA)
  • Vascular Medicine (AREA)
  • Transplantation (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Mechanical Engineering (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

The present invention provides a kind of dilating sacculus and sacculus dilating catheter, facilitate the effect for ensuring balloon expandable valve, additionally it is possible to reduce the structure complexity of sacculus dilating catheter and ensure the passability of conduit.Dilating sacculus of the invention includes the valve film for having the balloon body of intermediate channel and being set on the intermediate channel, the valve film stress after-contraction or expansion, so that the intermediate channel realizes one-way conduction.

Description

Dilating sacculus and sacculus dilating catheter
Technical field
The present invention relates to the field of medical instrument technology, in particular to a kind of dilating sacculus and sacculus dilating catheter.
Background technique
Since Inoue in 1984 successfully carries out Percutaneous balloon mitral valvotomy (PBV), PBV has become valvulopathy One of important method for the treatment of.Percutaneous balloon mitral valvotomy has many advantages, such as that wound is small, safe, curative for effect, in certain journey Instead of opening chest heart valve incision/exclusion on degree.For serious calcific aortic stenosis and surgical operation is avoided Or high-risk patient, it is applicable in through conduit aorta petal implantation (TAVI), valve sacculus is sent by femoral artery, by artificial heart Valve is delivered to aortic area opening, to complete artificial valve merging, restores valvular function.By valve sacculus to narrow Lesion expansion dredging is conducive to the implant procedure of valve bracket, while by after valve foley's tube after aorta petal implantation Expansion can make aorta petal attach, and effect is more preferable, and curative effect is more preferably.
In general, valve sacculus is designed to a kind of columned form.This design is conducive to sacculus in diseased region Uniform expansion avoids blood vessel overdistension from causing vascular tear to be bonded with blood vessel.However, columned sacculus exists Blood flow can be hindered to pass through in process of expansion, make heart transient ischemic, limited the valve surgery operability time, influence sacculus Valve effect is expanded, while after also leading to balloon expandable needing that pacemaker is cooperated to use.
When current valve balloon expandable, the design for allowing blood flow to pass through sacculus is a kind of hollow balloon structure, centre tool Have a moveable spherical balloon, be able to suppress blood and backflow from aorta to left ventricle, avoid increase left ventricle capacity and Output.But this design still remains problem: first is that guide-tube structure is complicated, being technically difficult to realize, and also reduces and lead The passability of pipe;Second is that valve sacculus outer surface is without fixed or constraint, the sacculus after making expansion may deform, sacculus is complied with Property is higher, influences balloon expandable valve effect, while calcific aortic valve lesion easily punctures sacculus.
Therefore, problems of the prior art are based on, it is necessary to a kind of novel aortic valve dilating sacculus is developed, To meet its use in aortic valve operation.
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 to Left 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 to The property crossed.
According to an aspect of the invention, there is provided a kind of dilating sacculus, the dilating sacculus includes having intermediate channel Balloon body and the valve film that is set on the intermediate channel;The valve film stress after-contraction or expansion, so that in described Between 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 valve Film 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 expansion Vertically or it is obliquely installed.
Optionally, the valve film be set to the intermediate channel proximally and distally between or the intermediate channel Distally.
Optionally, the material of the valve film is selected from fluoropolymer, polyesters, polyamide, polyvinyl chloride, nylon elastic One 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 body Outer surface fitting.
Optionally, the balloon body includes at least three sacculus bodies, at least three sacculus body parallel arrangeds and shape At 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 described The 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 tube Section 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 film It 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 catheter Be 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 or Expansion, 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, because This, which is suitable for unidirectional blood flow channel, especially heart valve.So aortic blood can be inhibited by valve film Liquid 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 technology On be easily achieved, and the overall size of conduit will not be increased, thereby it can be assured that the passability of conduit.
Detailed description of the invention
Attached drawing for a better understanding of the present invention, does not constitute an undue limitation on the present invention.Wherein:
Fig. 1 a is the structural schematic diagram of the sacculus dilating catheter of one embodiment of the invention;
Fig. 1 b is cross-sectional view of the sacculus dilating catheter shown in Fig. 1 a along B-B line;
Fig. 1 c is cross-sectional view of the sacculus dilating catheter along A-A line of Fig. 1 a;
Fig. 1 d is cross-sectional view of the sacculus dilating catheter along B-B line of Fig. 1 a;
Fig. 1 e is the structural schematic diagram of the valve film of one embodiment of the invention.
In figure:
100- sacculus dilating catheter, 10-1- dilating sacculus, 10-2- sacculus body, 1- flat segments, the nearly pipeline section of 2-, 3- are far managed Section, 4- outer tube, 5- inner tube, 6- overlay film, 7- valve film, 8- connecting line, 9- intermediate channel.
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 invention Dilating sacculus and its sacculus dilating catheter are described in further detail.It should be noted that attached drawing is all made of very simplified form And 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 interior In 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 into Enforcement, 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 to Close 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 heart Valve is delivered to aortic area opening, to complete artificial valve merging, restores valvular function.Wherein, pass through valve sacculus Stenotic lesion is expanded and is dredged, is conducive to the implant procedure of valve bracket, while expanding after aorta petal implantation by valve sacculus The 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 hair Bright 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 below In, 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 a Sacculus 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 line Cross-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 ball Capsule 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 not It is hindered, so can ensure the blood supply of heart duration, the valve surgery operability time is extended with this, improves ball Capsule 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 includes One 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 blood Stream 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 embodiment To conducting.Specifically: when blood flow enters aorta from left ventricle forward stream, the valve film 7 is impacted by blood flow occurs closure receipts It 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 regurgitation Percussion 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 7 Material, such as fluoropolymer, polyesters, polyamide, polyvinyl chloride, nylon elastomer, polyurethanes elastic rubber or two kinds Or 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 capacity And output, the effect of balloon expandable valve is ensured with this.Importantly, completing opening for valve film 7 only by the impact of blood flow It 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 figure Utricule 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 sacculus The 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 unlimited One hollow cylinder, the mode parallel arranged that can also be staggered and the internal formation intermediate channel 9.In the present embodiment, institute It 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 dimension 10-1。
Further, when the quantity of the sacculus body 10-2 is three or more, in an advantageous embodiment, two each other It 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 way The 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 centre Channel 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 can Using 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 body On, 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 intravascular Wall is contacted, since overlay film 6 can be preferably bonded with blood vessel, balloon expandable valve can be enhanced Effect.It is noted that the overlay film 6 can also play constraint styling to sacculus, the sacculus after making expansion will not be sent out Change 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 10-2 Intensity, 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 sacculus Compliance is pressed and reduces, to enhance balloon expandable power.It, can be by selecting different material or different in practical operation Molding 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 it Between;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 possible Thickness, 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 as One 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.Glue Epoxy 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 glue Overlay 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 used Select 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 distally Between;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 one The 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 consider To 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 structure With.So the valve film 7 can be located at the different location on intermediate channel 9.But unlimited setting one on the intermediate channel 9 Multiple 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 correspondence In 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 10-1 End, here, the closed end is fixedly installed, for being bonded with intermediate channel 9 after the open end expansion.When the valve film 7 When the open end is bonded with intermediate channel 9, the intermediate channel 9 is blocked;When the open end of the valve film 7 occurs When 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 9 Imitate size.Here, the effective dimensions of the intermediate channel 9, refers on the intermediate channel 9 for fitting with the open end Cavity 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 end It 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 with For 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 e Close the structure of another end opening.For cone, the bottom of the cone can be perpendicular relative to its short transverse Or 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 by It 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 d Section 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 1 Cross 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 at The 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 right Close 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 interior Pipe 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 interior The 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 outer The 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 inserted Enter 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 that The 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 close Pipeline 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 outer The 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 excellent Choosing, 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 interior Gap 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 2 The 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 medium Circulation passage, and another conduit part for being located at distal end can form plugging structure, wherein one conduit part is by multiple close Pipeline section 2 limits, another described conduit part is limited by multiple remote pipeline sections 3, in addition, the sacculus portion is by multiple sacculus 1 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 region Surface 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 embodiment Dilating sacculus 10-1 not only will not influence when expanding valve blood flow circulation, moreover it is possible to design larger-sized sacculus, meet The 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 ball Capsule 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 sacculus 10-1 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 selected Glue 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 7 Molten 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 type It 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 another End 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 company The 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 8 It 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 expandable Pipe, 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 stress The dilating sacculus so that the intermediate channel realizes one-way conduction, and then during surgery, is placed in human body by after-contraction or expansion When valve, blood flow can realize normal circulation by the intermediate channel, so that blood flow not will receive when expansion valve It influences, therefore, which is suitable for unidirectional blood flow channel, especially heart valve.So can inhibit main by valve film Arterial 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 special Other, which is adapted to without complicated conduit, therefore, reduce the structure complexity of sacculus dilating catheter and 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.
Foregoing description is only the description to present pre-ferred embodiments, not to any restriction of the scope of the invention, this hair Any change, the modification that the those of ordinary skill in bright field does according to the disclosure above content, belong to the protection of claims Range.

Claims (13)

1. a kind of dilating sacculus, which is characterized in that the dilating sacculus includes balloon body and the setting with intermediate channel In the valve film on the intermediate channel;The valve film stress after-contraction or expansion, so that the intermediate channel realizes one-way conduction.
2. dilating sacculus as described in claim 1, which is characterized in that the valve film have a cavity, the one of the cavity End seal is closed and another end opening;Wherein, the valve film forms closed one end fixed setting, while the valve film forms opening One end is connect with external agency.
3. dilating sacculus as claimed in claim 2, which is characterized in that be hollow cone, the cone after the valve film expansion The bottom of body relative to the cone high perpendicular or be obliquely installed.
4. dilating sacculus as described in claim 1, which is characterized in that the valve film be set to the intermediate channel distal end and Between the proximal end or distal end of the intermediate channel.
5. dilating sacculus as described in claim 1, which is characterized in that the material of the valve film is selected from fluoropolymer, polyester One of class, polyamide, polyvinyl chloride, nylon elastomer, polyurethane elastomer or multiple combinations.
6. dilating sacculus as described in claim 1, which is characterized in that it is provided with overlay film on the outer surface of the balloon body, The overlay film is partly bonded with the outer surface of the balloon body.
7. dilating sacculus as described in claim 1, which is characterized in that the balloon body includes at least three sacculus bodies, until Few three sacculus body parallel arrangeds and the formation intermediate channel.
8. a kind of sacculus dilating catheter, which is characterized in that including dilating sacculus such as of any of claims 1-7.
9. sacculus dilating catheter as claimed in claim 8, which is characterized in that the sacculus dilating catheter further include inner tube and Outer tube;Said inner tube is inserted into the outer tube, and said inner tube stretches out a section of the outer tube and is arranged with the dilating sacculus;Institute The distal end for stating dilating sacculus is connect with the section of said inner tube, a proximal end of the dilating sacculus and the outer tube and Said inner tube connection.
10. sacculus dilating catheter as claimed in claim 9, which is characterized in that one end of the valve film is fixed with said inner tube Closed end is connected and is formed, the other end of the valve film connect with said inner tube and/or the balloon body and forms open end.
11. sacculus dilating catheter as claimed in claim 10, which is characterized in that the other end of the valve film passes through more connections Line is connect with said inner tube and/or the balloon body.
12. sacculus dilating catheter as claimed in claim 11, which is characterized in that the connecting line passes through hot melt, suture or glue Water is connect with said inner tube and/or the balloon body.
13. sacculus dilating catheter as claimed in claim 11, which is characterized in that the connecting line passes through hot melt, suture or glue Water is connect with the other end of the valve film.
CN201810108074.5A 2018-02-02 2018-02-02 Dilating sacculus and sacculus dilating catheter Pending CN110123489A (en)

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CN116637277A (en) * 2023-05-17 2023-08-25 为泰医疗器械(深圳)有限公司 Valve shock wave saccule dilating catheter

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