CN108478310A - A kind of tricuspid valve forming ring of adjustable length and angle - Google Patents
A kind of tricuspid valve forming ring of adjustable length and angle Download PDFInfo
- Publication number
- CN108478310A CN108478310A CN201810585330.XA CN201810585330A CN108478310A CN 108478310 A CN108478310 A CN 108478310A CN 201810585330 A CN201810585330 A CN 201810585330A CN 108478310 A CN108478310 A CN 108478310A
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- Prior art keywords
- forming ring
- angle
- tricuspid valve
- cut
- adjustable length
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- 210000000591 tricuspid valve Anatomy 0.000 title claims abstract description 34
- 230000000694 effects Effects 0.000 claims abstract description 11
- 238000005452 bending Methods 0.000 claims abstract description 6
- 239000000835 fiber Substances 0.000 claims description 9
- 230000007704 transition Effects 0.000 claims description 8
- 239000004744 fabric Substances 0.000 claims description 7
- 239000002184 metal Substances 0.000 claims description 7
- 239000007787 solid Substances 0.000 claims description 6
- 230000007423 decrease Effects 0.000 claims description 4
- 230000036541 health Effects 0.000 claims description 3
- 238000000338 in vitro Methods 0.000 claims description 3
- 239000000203 mixture Substances 0.000 claims description 3
- 239000003086 colorant Substances 0.000 claims description 2
- 238000010422 painting Methods 0.000 claims description 2
- 230000000747 cardiac effect Effects 0.000 abstract description 9
- 210000003709 heart valve Anatomy 0.000 abstract description 5
- 201000010099 disease Diseases 0.000 abstract description 4
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 abstract description 4
- 230000002107 myocardial effect Effects 0.000 abstract description 4
- 230000033228 biological regulation Effects 0.000 abstract description 2
- 238000000465 moulding Methods 0.000 abstract description 2
- 230000003902 lesion Effects 0.000 description 6
- 230000033001 locomotion Effects 0.000 description 5
- 238000010586 diagram Methods 0.000 description 4
- 210000000709 aorta Anatomy 0.000 description 3
- 230000008859 change Effects 0.000 description 3
- 229910000831 Steel Inorganic materials 0.000 description 2
- 238000005516 engineering process Methods 0.000 description 2
- 210000004115 mitral valve Anatomy 0.000 description 2
- 230000004048 modification Effects 0.000 description 2
- 238000012986 modification Methods 0.000 description 2
- 239000010959 steel Substances 0.000 description 2
- 241001502050 Acis Species 0.000 description 1
- 208000025747 Rheumatic disease Diseases 0.000 description 1
- 201000001943 Tricuspid Valve Insufficiency Diseases 0.000 description 1
- 206010044640 Tricuspid valve incompetence Diseases 0.000 description 1
- 230000008901 benefit Effects 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- 150000001875 compounds Chemical class 0.000 description 1
- 239000012141 concentrate Substances 0.000 description 1
- 210000002808 connective tissue Anatomy 0.000 description 1
- 238000010276 construction Methods 0.000 description 1
- 230000001627 detrimental effect Effects 0.000 description 1
- 239000006185 dispersion Substances 0.000 description 1
- 238000002224 dissection Methods 0.000 description 1
- 230000006870 function Effects 0.000 description 1
- 230000004217 heart function Effects 0.000 description 1
- 238000002513 implantation Methods 0.000 description 1
- 238000003913 materials processing Methods 0.000 description 1
- 230000004660 morphological change Effects 0.000 description 1
- 230000000737 periodic effect Effects 0.000 description 1
- 230000002980 postoperative effect Effects 0.000 description 1
- 210000003102 pulmonary valve Anatomy 0.000 description 1
- 230000008439 repair process Effects 0.000 description 1
- 230000000552 rheumatic effect Effects 0.000 description 1
- 210000005241 right ventricle Anatomy 0.000 description 1
- 238000007142 ring opening reaction Methods 0.000 description 1
- 238000004088 simulation Methods 0.000 description 1
- 239000007779 soft material Substances 0.000 description 1
- 239000004753 textile Substances 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS 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
- A61F2/00—Filters 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
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart 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
- A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
- A61F2/2445—Annuloplasty rings in direct contact with the valve annulus
Landscapes
- Health & Medical Sciences (AREA)
- Cardiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Prostheses (AREA)
Abstract
The present invention provides a kind of tricuspid valve forming ring of adjustable length and angle, it is formed by that can cut part and part can not be cut, part can not be cut to be made of rigid stent and soft holder, rigid stent is close to soft rack inner wall and is fixed, rigid stent is divided into five sections, front and back section can adjust the bending angle of arc in firmly state, it can in time be adjusted in art and expand feature more to adapt to various disease Tricuspid annulus, preferably restore annulus normal size and shape, intermediate three sections of centrostigmas with dispersive stress, both ends can freely be twisted perpendicular to annulus plane, comply with cardiac shape variation.Reasonable design of the present invention, it is easy to use, adaptable, and the good implantable heart valve prosthesis forming ring of myocardial compliance, can solve the problems, such as formability and myocardial compliance can not be taken into account existing for existing forming ring, annulus and forming ring geometric shape do not agree with mutually cause to be unable to be molded in accurate match, art after can not regulation ring angle etc. to influence molding effect.
Description
Technical field
The invention belongs to Implantable Medical Device field more particularly to a kind of implantable heart valve prosthesis forming ring, tools
Body is related to a kind of tricuspid valve forming ring of adjustable length and angle, is the tricuspid valve forming ring in heart valve, is a kind of length
Degree can the four-dimensional fixed mobilizable tricuspid valve forming ring of two dimension in the adjustable part of crop angle.
Background technology
Human heart includes four valves, respectively aorta petal, bicuspid valve, tricuspid valve and pulmonary valve, four valves
It is one-way valve, ensures that blood is not flowed with the direction of mistake in cardiac cycle with this.In cardiac valvuloplasty field, people
Work annuloplasty band ring is used to repair or rebuild the heart valve annulus of lesion, relatively light suitable for valve and valve undertissue lesion,
Leaflet mobility preferably, mainly because annulus expand caused by (the referring mainly to bicuspid valve, tricuspid valve) incompetence of pure valve or
The case of the incompetence caused by rupture of chordae tendinca.Tricuspid valve is located at right atrioventricular orifice, the fiber branch constituted with dense connective tissue
It is attached with 3 triangle leaflets in mounting ring, claims tricuspid valve or right atrioventricular valve, and as solid shape and size occur for cardiac cycle
Variation, currently on the market forming ring mainly have flexi-ring, hard ring and elastic ring three classes.Flexi-ring complies with natural valve annulus aroused in interest
Movement in period can more meet normal physiological status and dissection tied with the size and shape of Unlimited cyclomorphosis annulus
Structure compliance, tricuspid valve forming ring flexi-ring have good compliance, but its support and forming effect are slightly worse, use flexi-ring
Patient has found phenomena such as tricuspid regurgitation recurrence aggravates easily occur during follow-up.Although and the hard ring of metal hard inner core is long
Phase effect stability can substantially reduce the incidence performed the operation again, but destroy the tricuspid annulus solid shape of physiological, lose
Being forced property of the motion morphology limitation of periodically variation, especially septal leaflet, and suture is easy avulsion at this, for right ventricle
Function also has certain detrimental effect.Ideal forming ring can be effectively adapted to while providing preferable support strength
Normal Tricuspid annulus structure is remolded in the compound movement of cardiac cycle, and suture is not easy avulsion, and implantation is easy, and can be fitted
Tricuspid annulus caused by various disease is answered to expand feature, because tricuspid valve forming ring currently used in the market is essentially according to Europe
What the characteristics of Tricuspid annulus caused by beautiful patient's retrogression expands was designed, and found with rheumatic according to the research of applicant
The most common lesion of Chinese based on lesion is based on tricuspid annulus is expanded and expanded with septal leaflet, to expand with the front and back valve of American-European crowd
For main different from, with the Tricusp Valvuloplasty ring designed based on abroad studies, there are a series of problems, mainly clinical most normal
The problem of seeing is that septal leaflet receives strength distortion gauffer when tricuspid valve puts loop forming, is susceptible to forming ring avulsion, tricuspid valve closure
Phenomena such as recurrence does not aggravate entirely.Therefore research starts to turn to elastic ring between flexi-ring and hard ring, to overcome flexi-ring and hard
The disadvantage of ring respectively, and extremely had according to the tricuspid valve forming ring that the design of various disease feature more meets the common lesion of Chinese
It is necessary.Since the ratio difference of the widened form of each patient's annulus and each leaflet is very big, and it is limited to be limited to model in art, can only
It will be with using.Therefore, we, which devise, may be adjusted to type ring, i.e., length can be cut, and the bending angle of annulus is adjustable, so as to
Change shapes and sizes during surgical, the tricuspid annulus that can adapt to Chinese and western various forms expands.
Invention content
The object of the present invention is to provide the tricuspid valve forming rings of a kind of adjustable length and angle, by that can cut part (1)
It is formed with part (2) can not be cut, connected end is equipped with mark line 5, and two free ports claim the ends E and the ends D, global shape close respectively
It is similar to ellipse jaggy, it is consistent (ends E are slightly below the ends D) with the tricuspid annulus shape of health.It is real that part (1), which can be cut,
The heart it is arc-shaped, be made of medical fibre fabric and its gel-filled gap, can any one position of clipping region cut after it is residual
End will not be loose;Can not cut part (2) also be it is arc-shaped, in vitro without applied external force when the ends E be slightly below plane;It can not cut
Part 2 is made of rigid stent (3) and soft holder (6), and rigid stent 3 is completely wrapped in soft holder 6, is to be close to
6 inner wall of soft holder is fixed from sliding, soft holder (6) construction with part (1) can be cut, be made of medical fibre fabric and
Its gel-filled gap is made, and the painting colo(u)r streak of mark line 5 in different colors Crop Area and can not cut junction to divide,
Excessively cause rigid stent (3) exposed to prevent from cutting out.Rigid stent 3 is by having both elastic one whole cylindrical metal with hardness
It suppresses, is divided into five sections, leading portion holder (7) can adjust the bending angle of arc with back segment holder (9) in firmly state, intermediate
Three sections be respectively both sides the movable holder of transition bracket (10) and center (8), wherein transition bracket (10) successively decreases in height
Oblate cylindricality, movable holder (8) is flaky, the rightmost side arc at the midpoint of movable holder 8 and entire tricuspid valve forming ring
Midpoint it is consistent, the ends E can be under the outer force effect of heartbeat vertically in the freely activity of annulus plane, but cannot be along arc
Direction is planar movable, i.e., cannot change radian.
The present invention is formed by one whole stamped metal, simpler relative to other materials processing technology and nonmagnetic, no
Influence magnetic resonance examination.It is solid arc-shaped that part, which can be cut out, is made of medical fibre fabric and its gel-filled gap, can
Stump will not be loose after any position in clipping region is cut, and valve structure before corresponding tricuspid valve, tailorable design keeps it more suitable
It answers individuation difference, soft material to help to protect the important feature around Tricuspid annulus, keeps it not easily damaged;It can not cut out
Part is made of nonmagnetic metal inside holder and the medical fibre textile flexibility housing being wrapped on inner core, the inner core
Shape and normal tricuspid valve septal leaflet are consistent with the shape of ring where back lobe, 5 sections of interior core support point, and front and back section holder can be firmly
State adjusts the bending angle of arc, can in time be adjusted in art and expand spy with the Tricuspid annulus for more adapting to different people
Point preferably restores annulus normal size and shape, and 3 sections of intermediate support point, being the transition bracket of both sides and center respectively can live
Dynamic holder composition, the oblate cylindricality that transition bracket successively decreases in height, with the centrostigma of dispersive stress, the movable holder in center is in thin
Sheet can be twisted freely perpendicular to annulus plane under external force, comply with the variation of periodic cardiac shape, prevent avulsion and
Protect heart function.Reasonable design of the present invention is a kind of easy to use, adaptable, and the implantable people that myocardial compliance is good
Work heart valve forming ring, can solve formability and myocardial compliance existing for existing forming ring can not take into account, annulus and at
Type ring geometric shape do not agree with mutually cause to be unable to be molded in accurate match, art after can not regulation ring angle etc. to influence at
The problem of type effect.
Description of the drawings
Fig. 1 is the structural schematic diagram of the present invention.
Fig. 2 is the schematic diagram of cross section A shown in Fig. 1.
Fig. 3 is the schematic diagram of cross section B shown in Fig. 1.
Fig. 4 is the schematic diagram of cross section C shown in Fig. 1.
Specific implementation mode
The specific implementation mode of the present invention is described in further detail with reference to the accompanying drawings and examples.Following embodiment
For illustrating the present invention, but it is not limited to the scope of the present invention.
In the description of the present invention, it is to be understood that, term "center", "front", "rear", "left", "right", "horizontal",
The orientation or positional relationship of instructions such as " vertical " is to be merely for convenience of describing based on attached orientation or positional relationship shown in FIG. 1
The present invention and simplified description, do not indicate or imply the indicated device or element must have a particular orientation, with specific
Azimuth configuration and operation, therefore be not considered as limiting the invention.
Embodiment 1
Referring to Fig. 1, Fig. 2, Fig. 3 and Fig. 4, a kind of length provided by the invention can the adjustable part of crop angle it is four-dimensional fixed
The mobilizable tricuspid valve forming ring of two dimension, is formed by that can cut part 1 and can not cut part 2, and connected end is equipped with mark line 5,
Two free ports claim the ends E and the ends D, global shape to be similar to the tricuspid valve annular with ellipse jaggy, and health respectively
Shape is consistent, and the major part of entire ring is medical fibre fabric and gel filled composition, has high-modulus, low creep, fatigue strength
High feature can make forming ring comply with movement of the natural valve annulus in cardiac cycle, meet normal physiological status.It can
It is solid arc-shaped to cut part 1, is made of medical fibre fabric and its gel-filled gap, can cut any of part 1
Stump 4 will not be loose after one position is cut, this tailorable design is to adapt to the preceding valve width of Different Individual;It is external
Research find before annulus expand more apparent (correspondence can clipping region), rear annulus expands that most apparent (correspondence can not Crop Area
The top half in domain), our research conclusion shows Chinese patients because the ethnic group cause of disease is different from foreign countries, and Chinese patients septal leaflet ring is past
Expand the lower half portion of clipping region (correspondence can not) toward apparent, design of the invention will expand or do not expand logical to each segment
With.Tri-aid rings abandon main this block of the roots A, this is reasonable, and it is most complicated and because of aorta pollex that it avoids stereochemical structure
It is easiest to the position torn.The design advantage of the present invention is:Part can be cut when operation, and to cut length lucky, when suture not
Contracting, no-station pole canopy, soft compliance well would not avulsion;This postoperative partial enlargement can be prevented Deng than putting after ring is fixed, and before ring
Hold fixed range long, the stress dispersion of suture, front and back annulus intersection is also just not easy avulsion;The design of annulus flexi-ring before simultaneously
It is the aorta petal structure in order to which tricuspid valve rear can be protected and the hardness drawing to conductive beam, hard annular state is fixed, can only
Agree with the annulus three-dimensional shape of a part of patient, often intractable after suture, especially head end can upwarp pushing outreach adduction,
It is easy avulsion suture and impair cardiac.Part 2 can not be cut also be it is solid arc-shaped, in vitro without applied external force when be in one
In the two dimensional surface of a distortion, the ends E are slightly below plane.Part 2 can not be cut to be made of rigid stent 3 and soft holder 6, hard
Holder 3 is completely wrapped in soft holder 6, is to be close to 6 inner wall of soft holder to be fixed from sliding, the rigid stent 3 of metal
Preferable support strength is provided, lesion Tricuspid annulus is effectively remolded, stablizes annulus structure, recurrence is eliminated and becomes
The risk of shape.Rigid stent 3 is suppressed by one whole cylindrical metal for having both elasticity and hardness, is divided into five sections, leading portion branch
Frame 7 and back segment holder 9 can adjust the bending angle of arc in firmly state, allow patient adjusted in time in art tricuspid valve at
Type ring is had a common boundary and the angle on the direction of rear septal leaflet boundary in front and back valve, ensures that molding effect, intermediate support are divided into three as far as possible
Section, is 2 sections of transition brackets 10 of both sides and the movable holder 8 at center respectively, and wherein transition bracket 10 successively decreases flat in height
Cylinder, movable holder 8 is flaky, and principle is for example same arc steel ruler, is only capable of living up and down in steel plain
It is dynamic, i.e., the ends E vertically can freely be twisted in annulus plane under the outer force effect of heartbeat (where the ends E can not cut out areas
Lower half portion can be higher than the ends D or be significantly lower than the ends D), but cannot cannot change along arcuate directions planar left and right activity
Radian.The design of this special shape and structure be simulation tricuspid valve in cardiac cycle complicated morphological change as a result, outstanding
It is the movement of tricuspid valve septal leaflet ring feature design the most apparent.Contracting septal leaflet annulus, annulus do not expand tight the hard ring listed
The patient of weight is placed in after Tricusp Valvuloplasty ring and is significantly wider than opening for ring every the corresponding interventricular septum width of portion's ring opening (E end regions)
Mouthful, it must form gauffer, the serious distortion shape of normal valve mouth, and (ends E) tension is made at the first needle of septal leaflet ring to greatly increase,
Cause avulsion.It is shown according to statistics, Chinese's septal leaflet ring is apparent widened more, and above-mentioned two problems are avoided in art.Solution party
Case:(1) head end is soft.(2) cannot be too anxious every boundary corner after forming ring, arc excessive.It is used since septal leaflet ring midpoint
Continuously or discontinuously suture, it is in " width concentrate around one point, as spokes on acis to make suture " shape, while reducing part septal leaflet annulus and back lobe annulus.Every boundary angle after originally
It spends " and desalinates ".
The above is only a preferred embodiment of the present invention, it is noted that for the ordinary skill people of the art
For member, without departing from the technical principles of the invention, several improvements and modifications, these improvements and modifications can also be made
Also it should be regarded as protection scope of the present invention.
Claims (8)
1. the tricuspid valve forming ring of a kind of adjustable length and angle, which is characterized in that by that can cut part (1) and can not cut
Partly (2) form, and connected end is equipped with mark line (5), and two free ports claim the ends E and the ends D respectively, can not cut part (2) by
Rigid stent (3) and soft holder (6) composition, rigid stent (3) are close to soft holder (6) inner wall and are fixed, rigid stent (3) point
It it is five sections, leading portion holder (7) can adjust the bending angle of arc with back segment holder (9) in firmly state, and intermediate three sections are respectively
The oblate cylindricality that the movable holder of transition bracket (10) and center (8) of both sides, wherein transition bracket (10) successively decrease in height, can
Movable support (8) is flaky.
2. the tricuspid valve forming ring of a kind of adjustable length according to claim 1 and angle, which is characterized in that whole shape
Shape is similar to ellipse jaggy, consistent with the tricuspid annulus shape of health, in vitro without applied external force when the ends E be less than D
End.
3. the tricuspid valve forming ring of a kind of adjustable length according to claim 1 and angle, which is characterized in that can cut
Partly (1) is solid arc-shaped, is made of medical fibre fabric and its gel-filled gap, can any one portion of clipping region
Stump (4) will not be loose after position is cut.
4. the tricuspid valve forming ring of a kind of adjustable length according to claim 1 and angle, which is characterized in that hard branch
Frame (3) is suppressed by one whole cylindrical metal for having both elasticity and hardness, is divided into five sections.
5. the tricuspid valve forming ring of a kind of adjustable length according to claim 1 and angle, which is characterized in that movable
The midpoint of the midpoint of holder (8) and the right side of entire tricuspid valve forming ring arc most outstanding is consistent.
6. the tricuspid valve forming ring of a kind of adjustable length according to claim 1 and angle, which is characterized in that mark line
(5) painting colo(u)r streak in different colors Crop Area and can not cut junction to divide, and excessively lead to hard to prevent from cutting out
Holder (3) is exposed.
7. the tricuspid valve forming ring of a kind of adjustable length according to claim 1 and angle, which is characterized in that soft branch
Frame (6) is identical as that can cut part (1), is made of medical fibre fabric and its gel-filled gap.
8. the tricuspid valve forming ring of a kind of adjustable length according to claim 1 and angle, which is characterized in that the ends E can
Vertically in the freely activity of annulus plane under the outer force effect of heartbeat, but cannot be planar movable along arcuate directions,
Radian cannot be changed.
Priority Applications (1)
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CN201810585330.XA CN108478310B (en) | 2018-06-08 | 2018-06-08 | Tricuspid valve forming ring with adjustable length and angle |
Applications Claiming Priority (1)
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CN201810585330.XA CN108478310B (en) | 2018-06-08 | 2018-06-08 | Tricuspid valve forming ring with adjustable length and angle |
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CN108478310A true CN108478310A (en) | 2018-09-04 |
CN108478310B CN108478310B (en) | 2024-05-03 |
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CN201810585330.XA Active CN108478310B (en) | 2018-06-08 | 2018-06-08 | Tricuspid valve forming ring with adjustable length and angle |
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Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN109620474A (en) * | 2018-11-24 | 2019-04-16 | 中国医学科学院阜外医院 | Type of extension tricuspid valve forming ring |
CN109662805A (en) * | 2019-01-18 | 2019-04-23 | 西安增材制造国家研究院有限公司 | A kind of Tricusp Valvuloplasty ring and its manufacturing method |
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Cited By (3)
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---|---|---|---|---|
CN109620474A (en) * | 2018-11-24 | 2019-04-16 | 中国医学科学院阜外医院 | Type of extension tricuspid valve forming ring |
CN109662805A (en) * | 2019-01-18 | 2019-04-23 | 西安增材制造国家研究院有限公司 | A kind of Tricusp Valvuloplasty ring and its manufacturing method |
CN109662805B (en) * | 2019-01-18 | 2024-02-13 | 西安增材制造国家研究院有限公司 | Tricuspid annuloplasty ring and method of making same |
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