CN109662805B - Tricuspid annuloplasty ring and method of making same - Google Patents

Tricuspid annuloplasty ring and method of making same Download PDF

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Publication number
CN109662805B
CN109662805B CN201910049085.5A CN201910049085A CN109662805B CN 109662805 B CN109662805 B CN 109662805B CN 201910049085 A CN201910049085 A CN 201910049085A CN 109662805 B CN109662805 B CN 109662805B
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Prior art keywords
ring
section
main body
tricuspid valve
ring section
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CN201910049085.5A
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CN109662805A (en
Inventor
王传彬
王晶
易蔚
卢秉恒
于颖
冯攀
谭彦振
徐学增
俞世强
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National Institute Corp of Additive Manufacturing Xian
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National Institute Corp of Additive Manufacturing Xian
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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
    • A61F2/2442Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • 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
    • A61F2240/00Manufacturing or designing of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2240/001Designing or manufacturing processes
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02PCLIMATE CHANGE MITIGATION TECHNOLOGIES IN THE PRODUCTION OR PROCESSING OF GOODS
    • Y02P10/00Technologies related to metal processing
    • Y02P10/25Process efficiency

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  • 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 relates to a tricuspid valve forming ring and a manufacturing method thereof, in order to overcome the technical problems of overlarge elastic modulus and partial closing insufficiency of the tricuspid valve forming ring when in use, a main body ring of the tricuspid valve forming ring sequentially comprises a first ring section, a middle ring section and a last ring section from one end to the other end, wherein the length of the first ring section is 23% -33% of the length of the main body ring, the middle ring section is 34% -54% of the length of the main body ring, and the last ring section is 23% -33% of the length of the main body ring; the middle ring section has an n-layer structure, and n is more than or equal to 2. The invention can individually customize the tricuspid valve forming ring, and the arc line of the tricuspid valve forming main body ring part is generated according to the valve edge of the patient to be applied by the product, can be accurately attached to the valve edge curve of the patient, and overcomes the phenomenon of partial insufficiency of the tricuspid valve ring; and the sectional shape of the existing tricuspid valve forming ring is improved, so that the elasticity of the tricuspid valve forming ring is convenient to adjust.

Description

Tricuspid annuloplasty ring and method of making same
Technical Field
The invention relates to a heart implant, in particular to a tricuspid valve forming ring and a manufacturing method thereof.
Background
The tricuspid annuloplasty ring is used to correct pathological annuloplasty, increase valve coaptation area, strengthen the shaped tricuspid annulus suture, and prevent the annulus from being excessively dilated again.
The existing tricuspid ring is mostly of a single-layer solid structure, and fig. 1-2 show structural diagrams of tricuspid rings produced by edwardsies, and the tricuspid rings of the structure have the following problems:
1. the tricuspid annuloplasty ring is mostly of a single-layer solid structure, has large elastic modulus, and is not suitable for patients with weak myocardial strength.
2. The tricuspid valve forming ring has several standard types, the production is carried out in batch by adopting the processes of die opening casting and the like, but patients have individual differences, and after a plurality of patients with special valve shapes adopt the standard type tricuspid valve forming ring, the phenomena of partial incomplete closing and the like still exist.
Disclosure of Invention
In order to overcome the technical problems of overlarge elastic modulus and partial closing insufficiency of the tricuspid valve forming ring in use, the invention provides the tricuspid valve forming ring and a manufacturing method thereof.
The technical scheme of the invention is as follows:
a tricuspid annuloplasty ring comprising a body ring which is a non-closed ring, characterized in that:
the main body ring sequentially comprises a first ring section 1, a middle ring section 2 and a last ring section 3 from one end to the other end, wherein the middle ring section 2 is of an n-layer structure, and n is more than or equal to 2.
Further, the length of the first ring section 1 is 23% -33% of the length of the main ring, the middle ring section 2 is 34% -54% of the length of the main ring, and the last ring section 3 is 23% -33% of the length of the main ring.
Further, the n=2.
Further, the first ring segment 1 comprises a first ring segment 11 and a second first ring segment 12, the last ring segment 3 comprises a first last ring segment 31 and a second last ring segment 32, the cross-section sizes of the first ring segment 11, the first last ring segment 31 and the middle ring segment 2 are fixed, the cross-section of the second first ring segment 12 is gradually changed from the cross-section of the first ring segment 11 to the cross-section of the middle ring segment 2, and the cross-section of the second last ring segment 32 is gradually changed from the cross-section of the middle ring segment 2 to the cross-section of the first last ring segment 31.
Further, the material of the main body ring adopts Ti6Al4V.
Meanwhile, the invention also provides a manufacturing method of the tricuspid valve forming ring, which is characterized by comprising the following steps:
1) Performing three-dimensional reconstruction according to CT/MRI scanning data of a patient to obtain a digital model of the tricuspid valve of the patient;
2) Extracting a peripheral curve of the tricuspid valve in a normal closed state from the digital model;
3) Body ring digital model determination
3.1 A peripheral curve is taken as a main body ring forming generatrix of the tricuspid valve forming ring;
3.2 Dividing the peripheral curve into a first ring segment curve, a middle ring segment curve and a last ring segment curve which correspond to each ring segment of the main body ring;
determining a first annular section, a middle annular section and a last annular section according to myocardial force of opening and closing of tricuspid valve of a patient;
3.3 Generating a main body ring digital model of the tricuspid valve forming ring according to the peripheral curve and the sections of the ring sections of the main body ring;
4) And importing the main body ring digital model into 3D pre-printing processing software, slicing, and printing by using a 3D printer.
Compared with the prior art, the invention has the beneficial effects that:
1. as the middle ring section of the main body ring is hollow, the tricuspid valve forming ring adopts a double-layer or multi-layer structure, and the elastic modulus of the main body ring is smaller than that of the existing forming ring with a single-layer solid structure, and the tricuspid valve forming ring is suitable for patients with weak myocardial force.
2. The middle ring section of the main body ring adopts a double-layer or multi-layer structure, so that the tricuspid valve forming ring is more convenient to elastically adjust and improves the elasticity in the vertical direction.
3. The manufacturing method of the tricuspid valve forming ring can customize the tricuspid valve forming ring individually, and the arc line of the main body ring part of the tricuspid valve forming ring is generated according to the peripheral curve of the applied patient tricuspid valve in a normal closed state. When the valve is used, the forming ring can be accurately attached to the valve edge curve of a patient, and the phenomenon of partial closing insufficiency of the tricuspid valve ring is overcome.
4. According to the manufacturing method of the tricuspid annuloplasty ring, the sections of all ring sections of the main body ring are determined according to the myocardial force of a patient, so that the tricuspid annuloplasty ring has proper elasticity, can be matched with the patient with weak myocardial force, and prevents incomplete valve opening.
Drawings
FIG. 1 is a drawing of the external appearance of Edwardsies company product;
FIG. 2 is a cross-sectional view of an Edwardsier product;
FIG. 3 is a block diagram of a tricuspid annuloplasty ring (bilayer) according to an embodiment of the invention;
FIG. 4 is a cross-sectional view of the intermediate ring segment of the tricuspid annuloplasty ring of FIG. 3;
FIG. 5 shows a cross-section of the body ring forming generatrix and body ring of the tricuspid valve forming ring according to an embodiment of the invention;
wherein the reference numerals are as follows: 1-first ring section, 11-first ring section, 12-second first ring section, 2-intermediate ring section, 3-last ring section, 31-first last ring section, 32-second last ring section, A-first ring section cross section, B-intermediate ring section cross section, C-first last ring section cross section.
Detailed Description
The present invention will be described in detail with reference to the accompanying drawings.
As shown in fig. 3-4, the tricuspid annuloplasty ring of the present invention comprises a main body ring, wherein the main body ring is a non-closed ring, the main body ring sequentially comprises a head ring section, a middle ring section 2 and a tail ring section from one end to the other end, the head ring section is used for being matched with a partition leaflet, the tail ring section is used for being matched with a rear leaflet, the length of the head ring section is 23% -33% of the length of the main body ring, the middle ring section 2 is 34% -54% of the length of the main body ring, and the tail ring section is 23% -33% of the length of the main body ring; the middle ring section 2 has a two-layer structure. The main body ring is made of Ti6Al4V.
The manufacturing method of the tricuspid ring comprises the following steps:
1) Performing three-dimensional reconstruction according to CT/MRI scanning data of a patient to obtain a digital model of the tricuspid valve of the patient;
2) Extracting a peripheral curve of the tricuspid valve in a normal closed state from the digital model;
3) Body ring digital model determination
3.1 A peripheral curve is taken as a main body ring forming generatrix of the tricuspid valve forming ring;
3.2 Dividing the peripheral curve into a first ring segment curve, a middle ring segment curve and a last ring segment curve which correspond to each ring segment of the main body ring;
the myocardial force of the opening and closing of the tricuspid valve of the patient is determined, and the section of the first ring segment, the section of the middle ring segment and the section of the last ring segment are determined according to the myocardial force of the opening and closing of the tricuspid valve of the patient.
As shown in fig. 5, the curve in fig. 5 is a main body ring forming bus, the shape on the curve corresponds to the section required by the curve, the first ring section and the last ring section are divided into two sections, the first ring section comprises a first ring section 11 and a second first ring section 12, the last ring section comprises a first last ring section 31 and a second last ring section 32, the sections of the first ring section 11, the middle ring section 2 and the first last ring section 31 are unchanged, the second first ring section 12 serves as a transition section between the first ring section 11 and the middle ring section 2, and the section is gradually changed; the second end ring segment 32 serves as a transition between the first end ring segment 31 and the intermediate ring segment 2, the cross-section also being gradual.
The whole main body ring only needs to determine a first ring section A, an intermediate ring section B and a first final ring section C, for example, the section of the first ring section 11 is A-A, the section of the second first ring section is gradually changed from A to B, the section of the intermediate ring section is B-B, the section of the second final ring section 32 is gradually changed from B to C, and the section of the first final ring section 31 is C-C.
3.3 Generating a main body ring digital model of the tricuspid valve forming ring according to the peripheral curve and the sections of the ring sections of the main body ring;
4) And importing the main body ring digital model into 3D pre-printing processing software, slicing, and printing by using a 3D printer.

Claims (4)

1. A tricuspid annuloplasty ring comprising a body ring, the body ring being a non-occlusive ring, characterized in that:
the main body ring sequentially comprises a first ring section (1), a middle ring section (2) and a last ring section (3) from one end to the other end, wherein the middle ring section (2) has an n-layer structure so as to facilitate elastic adjustment and improve the elasticity in the vertical direction; wherein n is more than or equal to 2;
the head ring section (1) is used for being matched with the lobule, and the tail ring section (3) is used for being matched with the rear lobule; the length of the first ring section (1) is 23% -33% of the length of the main ring, the middle ring section (2) is 34% -54% of the length of the main ring, and the last ring section (3) is 23% -33% of the length of the main ring;
the first ring section (1) comprises a first ring section (11) and a second first ring section (12), the end ring section (3) comprises a first end ring section (31) and a second end ring section (32), the cross section sizes of the first ring section (11), the first end ring section (31) and the middle ring section (2) are fixed, the cross section of the second first ring section (12) is gradually changed from the cross section of the first ring section (11) to the cross section of the middle ring section (2), and the cross section of the second end ring section (32) is gradually changed from the cross section of the middle ring section (2) to the cross section of the first end ring section (31);
the first ring segment (11) and the first last ring segment (31) are of a single-layer structure.
2. The tricuspid ring according to claim 1, wherein:
the n=2.
3. The tricuspid ring according to claim 2, wherein:
the main body ring is made of Ti6Al4V.
4. A method of manufacturing a tricuspid ring according to any one of claims 1 to 3, comprising the steps of:
1) Performing three-dimensional reconstruction according to CT/MRI scanning data of a patient to obtain a digital model of the tricuspid valve of the patient;
2) Extracting a peripheral curve of the tricuspid valve in a normal closed state from the digital model;
3) Body ring digital model determination
3.1 A peripheral curve is taken as a main body ring forming generatrix of the tricuspid valve forming ring;
3.2 Dividing the peripheral curve into a first ring segment curve, a middle ring segment curve and a last ring segment curve which correspond to each ring segment of the main body ring;
determining a first annular section, a middle annular section and a last annular section according to myocardial force of opening and closing of tricuspid valve of a patient;
3.3 Generating a main body ring digital model of the tricuspid valve forming ring according to the peripheral curve and the sections of the ring sections of the main body ring;
4) And importing the main body ring digital model into 3D pre-printing processing software, slicing, and printing by using a 3D printer.
CN201910049085.5A 2019-01-18 2019-01-18 Tricuspid annuloplasty ring and method of making same Active CN109662805B (en)

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CN109662805B true CN109662805B (en) 2024-02-13

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Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1719476A1 (en) * 2005-05-06 2006-11-08 Sorin Biomedica Cardio S.R.L. Annuloplasty prosthesis
CN102811680A (en) * 2010-01-22 2012-12-05 爱德华兹生命科学公司 Tricuspid ring
CN102985031A (en) * 2010-02-03 2013-03-20 美敦力Gbi有限公司 Semi-flexible annuloplasty ring
CN103249376A (en) * 2010-11-30 2013-08-14 爱德华兹生命科学公司 Reduced dehiscence annuloplasty ring
CN103735337A (en) * 2013-12-31 2014-04-23 金仕生物科技(常熟)有限公司 Artificial heart valve annuloplastic ring
WO2018055629A1 (en) * 2016-09-26 2018-03-29 Innercore Medical Ltd. Mitral valve repair device and method
CN108478310A (en) * 2018-06-08 2018-09-04 倪鸣 A kind of tricuspid valve forming ring of adjustable length and angle
CN210077949U (en) * 2019-01-18 2020-02-18 西安增材制造国家研究院有限公司 Tricuspid valve forming ring

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6908482B2 (en) * 2001-08-28 2005-06-21 Edwards Lifesciences Corporation Three-dimensional annuloplasty ring and template
US9295553B2 (en) * 2008-04-09 2016-03-29 Georgia Tech Research Corporation Annuloplasty rings and methods for heart valve repair
US20100152844A1 (en) * 2008-12-15 2010-06-17 Couetil Jean-Paul A Annuloplasty ring with directional flexibilities and rigidities to assist the mitral annulus dynamics

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1719476A1 (en) * 2005-05-06 2006-11-08 Sorin Biomedica Cardio S.R.L. Annuloplasty prosthesis
CN102811680A (en) * 2010-01-22 2012-12-05 爱德华兹生命科学公司 Tricuspid ring
CN102985031A (en) * 2010-02-03 2013-03-20 美敦力Gbi有限公司 Semi-flexible annuloplasty ring
CN103249376A (en) * 2010-11-30 2013-08-14 爱德华兹生命科学公司 Reduced dehiscence annuloplasty ring
CN103735337A (en) * 2013-12-31 2014-04-23 金仕生物科技(常熟)有限公司 Artificial heart valve annuloplastic ring
WO2018055629A1 (en) * 2016-09-26 2018-03-29 Innercore Medical Ltd. Mitral valve repair device and method
CN108478310A (en) * 2018-06-08 2018-09-04 倪鸣 A kind of tricuspid valve forming ring of adjustable length and angle
CN210077949U (en) * 2019-01-18 2020-02-18 西安增材制造国家研究院有限公司 Tricuspid valve forming ring

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