CN108478310B - Tricuspid valve forming ring with adjustable length and angle - Google Patents
Tricuspid valve forming ring with adjustable length and angle Download PDFInfo
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- CN108478310B CN108478310B CN201810585330.XA CN201810585330A CN108478310B CN 108478310 B CN108478310 B CN 108478310B CN 201810585330 A CN201810585330 A CN 201810585330A CN 108478310 B CN108478310 B CN 108478310B
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- 210000000591 tricuspid valve Anatomy 0.000 title claims abstract description 41
- 238000005452 bending Methods 0.000 claims abstract description 5
- 239000000835 fiber Substances 0.000 claims description 9
- 239000004744 fabric Substances 0.000 claims description 8
- 230000007704 transition Effects 0.000 claims description 8
- 239000002184 metal Substances 0.000 claims description 7
- 230000009471 action Effects 0.000 claims description 5
- 239000007787 solid Substances 0.000 claims description 5
- 230000010349 pulsation Effects 0.000 claims description 4
- 230000003247 decreasing effect Effects 0.000 claims description 3
- 239000003086 colorant Substances 0.000 claims description 2
- 238000009966 trimming Methods 0.000 claims 1
- 238000013461 design Methods 0.000 abstract description 10
- 230000008859 change Effects 0.000 abstract description 6
- 210000003709 heart valve Anatomy 0.000 abstract description 5
- 230000000694 effects Effects 0.000 abstract description 4
- 230000002107 myocardial effect Effects 0.000 abstract description 4
- 201000010099 disease Diseases 0.000 abstract description 3
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 abstract description 3
- 230000000747 cardiac effect Effects 0.000 description 4
- 238000011160 research Methods 0.000 description 4
- 229910000831 Steel Inorganic materials 0.000 description 3
- 238000006049 ring expansion reaction Methods 0.000 description 3
- 239000010959 steel Substances 0.000 description 3
- 210000001765 aortic valve Anatomy 0.000 description 2
- 230000003902 lesion Effects 0.000 description 2
- 210000004115 mitral valve Anatomy 0.000 description 2
- 238000012986 modification Methods 0.000 description 2
- 230000004048 modification Effects 0.000 description 2
- 230000004962 physiological condition Effects 0.000 description 2
- 208000025747 Rheumatic disease Diseases 0.000 description 1
- 210000003484 anatomy Anatomy 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- 210000003698 chordae tendineae Anatomy 0.000 description 1
- 210000002808 connective tissue Anatomy 0.000 description 1
- 230000000254 damaging effect Effects 0.000 description 1
- 230000007850 degeneration Effects 0.000 description 1
- 238000005516 engineering process 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
- 238000002955 isolation Methods 0.000 description 1
- 230000007774 longterm Effects 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 238000000034 method Methods 0.000 description 1
- 230000004660 morphological change Effects 0.000 description 1
- 231100000915 pathological change Toxicity 0.000 description 1
- 230000036285 pathological change Effects 0.000 description 1
- 230000008569 process Effects 0.000 description 1
- 238000012545 processing Methods 0.000 description 1
- 210000003102 pulmonary valve Anatomy 0.000 description 1
- 238000010992 reflux Methods 0.000 description 1
- 210000005241 right ventricle Anatomy 0.000 description 1
- 238000000926 separation method Methods 0.000 description 1
- 238000007493 shaping process Methods 0.000 description 1
- 239000007779 soft material Substances 0.000 description 1
- 238000001356 surgical procedure Methods 0.000 description 1
- 210000001519 tissue Anatomy 0.000 description 1
- 230000037303 wrinkles Effects 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 invention provides a tricuspid valve forming ring with adjustable length and angle, which consists of a tailorable part and a non-tailorable part, wherein the non-tailorable part consists of a hard support and a soft support, the hard support is tightly fixed on the inner wall of the soft support and is divided into five sections, the front section and the rear section can adjust the arc-shaped bending angle in a forced state, so that the tricuspid valve forming ring can be timely adjusted in operation to adapt to the expansion characteristics of tricuspid valve rings with different diseases, the normal size and shape of the valve rings can be better recovered, the middle three sections can be used for dispersing stress concentration points, and the two ends can freely twist perpendicular to the plane of the valve rings to conform to the shape change of hearts. The implantable artificial heart valve forming ring is reasonable in design, convenient to use, high in adaptability and good in myocardial compliance, and can solve the problems that the forming performance and the myocardial compliance of the existing forming ring cannot be compatible, the geometric forms of the valve ring and the forming ring are not matched with each other, the angle of the ring cannot be adjusted after the forming in an operation and the like, so that the forming effect is affected.
Description
Technical Field
The invention belongs to the field of implantable medical equipment, and particularly relates to an implantable artificial heart valve forming ring, in particular to a tricuspid valve forming ring with adjustable length and angle, which is a tricuspid valve forming ring in a heart valve and is a tricuspid valve forming ring with adjustable length and cutting angle, and local four-dimensional fixation and two-dimensional movement.
Background
The human heart comprises four valves, namely an aortic valve, a mitral valve, a tricuspid valve and a pulmonary valve, which are all unidirectional valves, so as to ensure that blood does not flow in the wrong direction in the cardiac cycle. In the field of heart annuloplasty, the prosthetic annuloplasty ring is used for repairing or reconstructing a diseased heart valve annulus, and is suitable for cases of simple valve (mainly mitral valve and tricuspid valve) insufficiency caused by valve and subvalvular tissue lesions, better valve leaflet mobility, and mainly valve annulus enlargement or insufficiency caused by chordae tendineae fracture. The tricuspid valve is positioned at the right atrioventricular orifice, 3 triangular valve leaves are attached to a fiber support ring formed by compact connective tissues, the tricuspid valve or the right atrioventricular valve is called, and three types of soft rings, hard rings and elastic rings are mainly used as forming rings in the market at present along with the change of three-dimensional forms and sizes of cardiac cycles. The soft ring conforms to the movement of the natural valve annulus in the heart cycle, the size and shape of the valve ring can be changed along with the heart cycle, the soft ring conforms to the normal physiological condition and anatomical structure compliance, the tricuspid valve forming ring has good compliance, but the supporting and forming effects are slightly poor, and the phenomenon that the tricuspid valve is easy to be subjected to reflux and relapse and the like is found in the follow-up process of a patient using the soft ring. The hard ring of the metal hard inner core has stable long-term effect, can obviously reduce the incidence rate of re-operation, but destroys the three-dimensional form of the tricuspid annulus, loses periodical change, particularly the movement form of the isolation valve is forcedly limited, and the suture is easy to tear off, thereby having certain damaging effect on the function of the right ventricle. The ideal forming ring can effectively adapt to the complex movement of the cardiac cycle while providing better supporting strength, remodels the normal tricuspid valve ring structure, sutures are not easy to tear off, implantation is easy, and the forming ring can adapt to the characteristics of tricuspid valve ring expansion caused by different diseases, because the tricuspid valve forming ring used in the market at present is basically designed according to the characteristics of tricuspid valve ring expansion caused by the degeneration of European and American patients, the most common pathological changes of Chinese people mainly including rheumatic diseases are found to be the tricuspid valve ring expansion mainly including valve expansion according to the research of the applicant, the tricuspid valve forming ring designed based on western research is different from the front and rear valve expansion mainly including the front and rear valve expansion of European and American people, a series of problems exist, and the most common clinical problems are that the tricuspid valve ring is subjected to strong distortion and crease when being formed, the forming ring tear off easily occurs, the phenomenon of the recurrence and the like of tricuspid valve is difficult to close. It is therefore necessary to start the study turning to the elastic ring between the soft and hard rings to overcome the respective drawbacks of the soft and hard rings and to design the tricuspid ring according to different disease characteristics, which is more in line with the common lesions of chinese. The expanded form of the valve annulus and the proportion of the valve leaves of each patient are greatly different, and the operation is limited to a limited model, so that the valve can be used only in the future. Therefore, we have devised an adjustable shaping ring, i.e. a length-adjustable, with the angle of curvature of the annulus adjustable, so as to change shape and size during the surgical procedure, so that it can accommodate tricuspid ring enlargement in various forms in the middle and west.
Disclosure of Invention
The invention aims to provide a tricuspid valve forming ring with adjustable length and angle, which consists of a tailorable part (1) and a non-tailorable part (2), wherein a marking line 5 is arranged at the connecting end, two free ports are respectively called an E end and a D end, the whole shape is similar to an ellipse with a notch, and the shape is consistent with the shape of a healthy tricuspid valve ring (the E end is slightly lower than the D end). The cuttable part (1) is in a solid circular arc shape, is made by filling a gap between medical fiber fabrics and gel, and the stump of any part of the cuttable area is not loosened after being cut; the non-cutting part (2) is also arc-shaped, and the E end is slightly lower than the plane when no external force is applied outside the body; the non-cutting part 2 consists of a hard support (3) and a soft support (6), the hard support 3 is completely wrapped in the soft support 6, the soft support (6) is tightly fixed on the inner wall of the soft support 6 and cannot slide, the soft support (6) is constructed like the cutting part (1), the non-cutting part is made of medical fiber fabrics and is filled with gel, and the marking lines 5 are used for dividing the cutting areas and the non-cutting joints by using colored lines with different colors so as to prevent the hard support (3) from being exposed due to excessive cutting. The hard support 3 is formed by pressing a whole cylindrical metal with elasticity and hardness, and is divided into five sections, the front section support (7) and the rear section support (9) can adjust the arc-shaped bending angle in a forced state, the middle three sections are a transition support (10) and a center movable support (8) on two sides respectively, wherein the transition support (10) is in a flat cylindrical shape with a decreasing height, the movable support (8) is in a sheet shape, the middle point of the movable support (8) is consistent with the middle point of the rightmost arc of the whole tricuspid valve forming ring, and the E end can freely move perpendicular to the plane of the valve ring under the action of external force of heart pulsation, but cannot move in the plane along the arc direction, namely cannot change radian.
The invention is pressed by a whole metal, is simpler than other materials in processing technology, is nonmagnetic and does not influence magnetic resonance examination. The cuttable part is in a solid circular arc shape, and is made by filling a gap between medical fiber fabrics and gel, the residual end of any part of the cuttable region is not loosened after being cut, and the cuttable part corresponds to the anterior tricuspid valve structure, and the cuttable part is more suitable for individual differences due to the design, and the soft material is beneficial to protecting important structures around the tricuspid valve ring, so that the tricuspid valve ring is not easy to damage; the non-cutting part consists of a non-magnetic metal inner core support and a medical fiber fabric flexible jacket wrapped on the inner core, the shape of the inner core is consistent with the shape of an annulus where a normal tricuspid valve is located, the inner core support is divided into 5 sections, the front section support and the rear section support can adjust the arc-shaped bending angle in a forced state, so that the front section support and the rear section support can be timely adjusted in operation to adapt to the expansion characteristics of tricuspid valve annuluses of different people, the normal size and the shape of the valve annuluses can be better recovered, the middle support is divided into 3 sections, and consists of transition supports and a center movable support on two sides respectively, wherein the transition supports are in a flat cylinder shape with reduced height so as to disperse stress concentration points, and the center movable support is in a sheet shape and can freely twist perpendicular to the plane of the valve annulus under the action of external force, conforms to the periodical heart shape change, and prevents tearing and protects heart functions. The invention has reasonable design, is an implantable artificial heart valve forming ring with convenient use, strong adaptability and good myocardial compliance, and can solve the problems that the forming performance and the myocardial compliance of the existing forming ring can not be compatible, the geometric forms of the valve ring and the forming ring are mutually not matched, the angle of the ring can not be adjusted after the forming in operation, and the like, thereby influencing the forming effect.
Drawings
Fig. 1 is a schematic structural view of the present invention.
Fig. 2is a schematic view of the cross section a shown in fig. 1.
Fig. 3 is a schematic view of the cross section B shown in fig. 1.
Fig. 4 is a schematic view of the cross section C shown in fig. 1.
Detailed Description
The following describes in further detail the embodiments of the present invention with reference to the drawings and examples. The following examples are illustrative of the invention and are not intended to limit the scope of the invention.
In the description of the present invention, it should be understood that the terms "center", "front", "rear", "left", "right", "horizontal", "vertical", and the like indicate orientations or positional relationships based on the orientation or positional relationships shown in fig. 1, are merely for convenience in describing the present invention and simplifying the description, and do not indicate or imply that the devices or elements referred to must have a specific orientation, be configured and operated in a specific orientation, and thus should not be construed as limiting the present invention.
Example 1
Referring to fig. 1,2, 3 and 4, the invention provides a length-adjustable local four-dimensional fixed two-dimensional movable tricuspid valve forming ring, which consists of a tailorable part 1 and a non-tailorable part 2, wherein the connecting end is provided with a marking line 5, two free ports are respectively called an E end and a D end, the whole shape is similar to an ellipse with a notch, the shape is consistent with a healthy tricuspid valve ring, most of the whole ring consists of medical fiber fabric and filling gel, and the invention has the characteristics of high modulus, low creep and high fatigue strength, and can enable the forming ring to conform to the movement of a natural valve ring in a cardiac cycle and conform to normal physiological conditions. The cuttable part 1 is in a solid circular arc shape, and is made by filling gaps with medical fiber fabric and gel, the residual end 4 of any part of the cuttable part 1 is not loosened after being cut, and the design of the cuttable part is to adapt to the front flap width of different individuals; foreign researches find that the anterior annulus is obviously enlarged (corresponding to the tailorable region), the posterior annulus is most obviously enlarged (corresponding to the upper half of the non-tailorable region), and our research conclusion shows that the Chinese patient's annulus is obviously enlarged (corresponding to the lower half of the non-tailorable region) due to different human etiology from foreign countries, and the design of the invention is universal for enlarging or not enlarging each segment. The Tri-aid ring gives up the main root a, which is reasonable, and avoids the site where the three-dimensional structure is the most complex and the most easily torn due to the arterial pulsation. The design of the invention has the advantages that: the cuttable part is cut to the right length during operation, the suture is not contracted, tension is not generated, and the flexible compliance is good, so that the cuttable part can not be torn off; the equal-ratio ring can prevent the expansion of the part after operation after fixation, the front end of the ring is long in distance, the stress of the suture is dispersed, and the junction of the front and rear valve rings is not easy to tear; meanwhile, the design of the soft ring for the anterior valve is to protect the aortic valve structure behind the tricuspid valve and hard traction on the guide beam, the hard ring is fixed and can only be matched with the three-dimensional shape of the valve ring of a part of patients, the patient can not be fit after being frequently sutured, and especially the head end can be tilted up, pressed down and abducted and adducted, so that the suture is easy to tear and the heart is easy to be damaged. The non-cutting part 2 is also in a solid circular arc shape, and is positioned in a distorted two-dimensional plane when no external force is applied outside the body, and the E end is slightly lower than the plane. The non-cutting part 2 consists of a hard support 3 and a soft support 6, wherein the hard support 3 is completely wrapped in the soft support 6, is tightly fixed on the inner wall of the soft support 6 and cannot slide, and the metal hard support 3 provides better supporting strength, so that the diseased tricuspid valve annulus is effectively remolded, the valve annulus structure is stabilized, and the risk of recurrence deformation is eliminated. The hard support 3 is formed by pressing a whole cylindrical metal with elasticity and hardness, and is divided into five sections, the front section support 7 and the rear section support 9 can adjust the arc bending angle in a forced state, so that an operator can timely adjust the angle of a tricuspid valve forming ring in the junction direction of the front valve and the rear valve and the junction direction of the rear valve in the operation, the forming effect is ensured as far as possible, the middle support is divided into three sections, namely a 2-section transition support 10 on two sides and a movable support 8 in the center, wherein the transition support 10 is in a flat cylindrical shape with the decreasing height, the movable support 8 is in a sheet shape, the principle is like the same arc steel rule, the arc steel rule can only move up and down in a plane perpendicular to a steel plate plane, namely, the E end can freely twist in a plane perpendicular to the valve ring under the action of external force of heart pulsation (the lower half part of an unclamped area where the E end is located can be higher than the D end or obviously lower than the D end, but can not move left and right in the plane along the arc direction, and the radian cannot be changed). This particular shape and configuration design is a characteristic design that mimics the consequences of complex morphological changes in the tricuspid valve during the heart cycle, especially the most pronounced movement of the tricuspid valve annulus. The hard rings on the market do not shrink to separate the valve annulus, the valve annulus is enlarged to be placed in the opening of the valve annulus at the back of the tricuspid valve forming ring (E end) to be corresponding to the space width of the chamber, which is much wider than the opening of the ring, so that wrinkles are necessarily formed, the shape of a normal valve orifice is severely distorted, and the tension at the first needle of the valve annulus (E end) is greatly increased, so that the valve annulus is torn off. According to statistics, the valve annulus of the Chinese is obviously enlarged, and the two problems are avoided in operation. The solution is as follows: (1) the head end is soft. (2) The posterior interface corners of the forming ring should not be too sharp and are too arcuate. The suture is continuously or intermittently sutured from the midpoint of the valve annulus to make the suture in a 'vergence' shape, and the contracted part separates the valve annulus from the back valve annulus. The original back separation boundary angle is "desalted".
The foregoing is merely a preferred embodiment of the present invention, and it should be noted that it will be apparent to those skilled in the art that modifications and variations can be made without departing from the technical principles of the present invention, and these modifications and variations should also be regarded as the scope of the invention.
Claims (7)
1. The tricuspid valve forming ring with adjustable length and angle is characterized by comprising a tailorable part (1) and a non-tailorable part (2), wherein a marking line (5) is arranged at the connecting end, two free ports are respectively called an E end and a D end, the non-tailorable part (2) consists of a hard support (3) and a soft support (6), the hard support (3) is tightly attached to the inner wall of the soft support (6) and fixed, the hard support (3) is divided into five sections, the front section support (7) and the rear section support (9) can adjust the arc-shaped bending angle in a forced state, the middle three sections are respectively a transition support (10) and a central movable support (8) at two sides, the transition support (10) is in a flat cylindrical shape with decreasing height, and the movable support (8) is in a sheet shape and freely twists perpendicular to the plane of the valve ring under the action of external force; namely, the E end freely moves perpendicular to the plane of the valve annulus under the action of the external force of heart pulsation, but cannot move in the plane along the arc direction, namely, the radian cannot be changed; the overall shape approximates an oval with a notch, conforming to the shape of a healthy tricuspid annulus.
2. The adjustable length and angle tricuspid ring according to claim 1, wherein the E end is lower than the D end in the absence of external forces.
3. A tricuspid valve according to claim 1, with adjustable length and angle, wherein the trimmable part (1) is in the form of a solid circular arc, and is made by filling the space between a medical fibre fabric and a gel, and the trimmable area is free from loosening after trimming of any part of the trimmable area (4).
4. A tricuspid valve according to claim 1, with adjustable length and angle, wherein the rigid support (3) is made of a single cylindrical metal with both elasticity and hardness by pressing, divided into five sections.
5. A tricuspid ring according to claim 1, with adjustable length and angle, wherein the midpoint of the movable support (8) coincides with the midpoint of the most protruding arc on the right side of the entire tricuspid ring.
6. A tricuspid ring according to claim 1, with adjustable length and angle, wherein the marking lines (5) are coloured lines of different colours to divide the tailorable region and the non-tailorable junction, so as to prevent overcorrection of tailoraring from causing the barefoot of the rigid stent (3).
7. Tricuspid ring according to claim 1, with adjustable length and angle, characterized in that the soft stent (6) is made of the same as the trimmable part (1), with a medical fibre fabric and gel filling the gap between them.
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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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CN201810585330.XA CN108478310B (en) | 2018-06-08 | 2018-06-08 | Tricuspid valve forming ring with adjustable length and angle |
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CN108478310A CN108478310A (en) | 2018-09-04 |
CN108478310B true 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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Families Citing this family (2)
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CN109620474B (en) * | 2018-11-24 | 2021-09-03 | 中国医学科学院阜外医院 | Extensible tricuspid valve forming ring |
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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CN102088930A (en) * | 2008-05-13 | 2011-06-08 | 爱德华兹生命科学公司 | Physiologically harmonized tricuspid annuloplasty ring |
EP2531143A1 (en) * | 2010-02-03 | 2012-12-12 | Medtronic GBI, Inc. | Semi-flexible annuloplasty ring |
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CN104000670A (en) * | 2013-02-27 | 2014-08-27 | 金仕生物科技(常熟)有限公司 | Adjustable artificial valve ring |
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Family Cites Families (2)
Publication number | Priority date | Publication date | Assignee | Title |
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US8206439B2 (en) * | 2004-02-23 | 2012-06-26 | International Heart Institute Of Montana Foundation | Internal prosthesis for reconstruction of cardiac geometry |
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- 2018-06-08 CN CN201810585330.XA patent/CN108478310B/en active Active
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CN102088930A (en) * | 2008-05-13 | 2011-06-08 | 爱德华兹生命科学公司 | Physiologically harmonized tricuspid annuloplasty ring |
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CN104000670A (en) * | 2013-02-27 | 2014-08-27 | 金仕生物科技(常熟)有限公司 | Adjustable artificial valve ring |
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