WO2018049492A1 - Method for producing an expandable heart valve stent from a polyurethane membrane and polyurethane membrane valve stent that can be implanted using a catheter in adult and pediatric patients - Google Patents
Method for producing an expandable heart valve stent from a polyurethane membrane and polyurethane membrane valve stent that can be implanted using a catheter in adult and pediatric patients Download PDFInfo
- Publication number
- WO2018049492A1 WO2018049492A1 PCT/BR2017/000078 BR2017000078W WO2018049492A1 WO 2018049492 A1 WO2018049492 A1 WO 2018049492A1 BR 2017000078 W BR2017000078 W BR 2017000078W WO 2018049492 A1 WO2018049492 A1 WO 2018049492A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- polyurethane
- stent
- valve
- prosthesis
- catheter
- Prior art date
Links
- 239000004814 polyurethane Substances 0.000 title claims abstract description 39
- 229920002635 polyurethane Polymers 0.000 title claims abstract description 38
- 210000003709 heart valve Anatomy 0.000 title claims abstract description 19
- 239000012528 membrane Substances 0.000 title claims description 10
- 238000004519 manufacturing process Methods 0.000 title claims description 3
- 238000000034 method Methods 0.000 claims abstract description 13
- 238000002513 implantation Methods 0.000 claims description 6
- 229910000684 Cobalt-chrome Inorganic materials 0.000 claims description 4
- 239000010952 cobalt-chrome Substances 0.000 claims description 4
- 239000000463 material Substances 0.000 claims description 4
- 230000001143 conditioned effect Effects 0.000 claims description 3
- 230000010102 embolization Effects 0.000 claims description 3
- 230000002685 pulmonary effect Effects 0.000 claims description 3
- 239000000126 substance Substances 0.000 claims description 3
- 241001465754 Metazoa Species 0.000 claims description 2
- 230000015572 biosynthetic process Effects 0.000 claims description 2
- 238000010276 construction Methods 0.000 claims description 2
- 230000004064 dysfunction Effects 0.000 claims description 2
- 230000005855 radiation Effects 0.000 claims description 2
- 238000001356 surgical procedure Methods 0.000 claims description 2
- 230000002045 lasting effect Effects 0.000 claims 1
- 230000002308 calcification Effects 0.000 abstract description 2
- IUWCPXJTIPQGTE-UHFFFAOYSA-N chromium cobalt Chemical compound [Cr].[Co].[Co].[Co] IUWCPXJTIPQGTE-UHFFFAOYSA-N 0.000 abstract 1
- 239000004744 fabric Substances 0.000 abstract 1
- 239000007788 liquid Substances 0.000 abstract 1
- 239000010409 thin film Substances 0.000 abstract 1
- 238000006243 chemical reaction Methods 0.000 description 3
- 239000002994 raw material Substances 0.000 description 3
- 208000007536 Thrombosis Diseases 0.000 description 2
- -1 aromatic isocyanates Chemical class 0.000 description 2
- 230000000747 cardiac effect Effects 0.000 description 2
- 238000002788 crimping Methods 0.000 description 2
- 230000002068 genetic effect Effects 0.000 description 2
- 125000002887 hydroxy group Chemical group [H]O* 0.000 description 2
- 239000012948 isocyanate Substances 0.000 description 2
- 230000000704 physical effect Effects 0.000 description 2
- BASFCYQUMIYNBI-UHFFFAOYSA-N platinum Chemical compound [Pt] BASFCYQUMIYNBI-UHFFFAOYSA-N 0.000 description 2
- 208000004434 Calcinosis Diseases 0.000 description 1
- 206010010356 Congenital anomaly Diseases 0.000 description 1
- 241000282412 Homo Species 0.000 description 1
- 208000031481 Pathologic Constriction Diseases 0.000 description 1
- 235000014443 Pyrus communis Nutrition 0.000 description 1
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 1
- 210000003484 anatomy Anatomy 0.000 description 1
- 210000001765 aortic valve Anatomy 0.000 description 1
- 230000008827 biological function Effects 0.000 description 1
- 230000017531 blood circulation Effects 0.000 description 1
- 238000004590 computer program Methods 0.000 description 1
- 230000000916 dilatatory effect Effects 0.000 description 1
- 206010016256 fatigue Diseases 0.000 description 1
- 239000012530 fluid Substances 0.000 description 1
- 208000019622 heart disease Diseases 0.000 description 1
- 239000007943 implant Substances 0.000 description 1
- 208000015181 infectious disease Diseases 0.000 description 1
- 238000002347 injection Methods 0.000 description 1
- 239000007924 injection Substances 0.000 description 1
- 230000002452 interceptive effect Effects 0.000 description 1
- 229910052741 iridium Inorganic materials 0.000 description 1
- GKOZUEZYRPOHIO-UHFFFAOYSA-N iridium atom Chemical compound [Ir] GKOZUEZYRPOHIO-UHFFFAOYSA-N 0.000 description 1
- IQPQWNKOIGAROB-UHFFFAOYSA-N isocyanate group Chemical group [N-]=C=O IQPQWNKOIGAROB-UHFFFAOYSA-N 0.000 description 1
- 150000002513 isocyanates Chemical class 0.000 description 1
- 238000009533 lab test Methods 0.000 description 1
- 229920002521 macromolecule Polymers 0.000 description 1
- 230000036244 malformation Effects 0.000 description 1
- 229910052751 metal Inorganic materials 0.000 description 1
- 239000002184 metal Substances 0.000 description 1
- 239000002245 particle Substances 0.000 description 1
- 230000002093 peripheral effect Effects 0.000 description 1
- 229910052697 platinum Inorganic materials 0.000 description 1
- 238000005498 polishing Methods 0.000 description 1
- 229920000642 polymer Polymers 0.000 description 1
- 229920001343 polytetrafluoroethylene Polymers 0.000 description 1
- 239000004810 polytetrafluoroethylene Substances 0.000 description 1
- 230000002980 postoperative effect Effects 0.000 description 1
- 238000002360 preparation method Methods 0.000 description 1
- 239000011780 sodium chloride Substances 0.000 description 1
- 239000007787 solid Substances 0.000 description 1
- 239000000243 solution Substances 0.000 description 1
- 230000036262 stenosis Effects 0.000 description 1
- 208000037804 stenosis Diseases 0.000 description 1
- JOYRKODLDBILNP-UHFFFAOYSA-N urethane group Chemical group NC(=O)OCC JOYRKODLDBILNP-UHFFFAOYSA-N 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
- A61F2/2412—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 with soft flexible valve members, e.g. tissue valves shaped like natural valves
- A61F2/2415—Manufacturing methods
-
- 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
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
- A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
- A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
-
- 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
- A61F2/2412—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 with soft flexible valve members, e.g. tissue valves shaped like natural valves
-
- 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
- A61F2/2412—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 with soft flexible valve members, e.g. tissue valves shaped like natural valves
- A61F2/2418—Scaffolds therefor, e.g. support stents
-
- 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
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
- A61F2250/006—Additional features; Implant or prostheses properties not otherwise provided for modular
Definitions
- the main object of the present invention is to propose a method indicated to serve as a method of obtaining a cardiac valve stent model made from a synthetic membrane, type polyurethane to be employed in medical (surgical) procedures such as aim to solve problems of anatomical and functional problems related to cardiac malformations and acquired heart disease in humans in the following situations:
- the cardiac prosthesis contains a structure polyurethane, which has desirable characteristics such as: biostability and biocompatibility with the recipient organism, as well as being efficient and resistant to fatigue, calcification, thrombosis and infection, in order to fulfill the biological function of the natural anatomical structure to be replaced. .
- polyurethane as Material Group consisting of macromolecules with urethane bonding over and over, usually result of the reaction of isocyanate with hydroxyl groups, both di or polyfunctional.
- isocyanate with hydroxyl groups, both di or polyfunctional.
- polyurethane chain configuration can range from regular or random to junction or cross, which will determine the physical properties of the synthesized material. Therefore one should be encouraged to the chain segments when it is desired to obtain products with specific properties, being factors directly linked to the type of raw material employed.
- FIG. 1 Stent design: Consisting of a pre-molded, laser-cut cobalt chrome mesh.
- the stent receives polishing and a polytetrafluoroethylene bath to reduce the chance of thrombus formation.
- the stems have particle physical characteristics: they are flexible when subjected to fluid flow under pressure, reducing the wear of the membrane applied over the stent.
- FIG. 2 Valve stent design: A thin 0.2 to 0.3 mm polyurethane membrane (1) was applied over the ostentate forming three flexible cusps without the use of sutures and a maximum opening mechanism equal to the diameter. larger stent 22 mm and hermetic closure at the base of the stems, mimicking the human aortic and pulmonary sigmoid valves. There is a limit of application of polyurethane (2), 6 mm from the lower edge of the stent, keeping this segment of the cobalt chrome mesh (3) free of polyurethane, exposing a surface suitable for stent attachment in the patient's valve annulus.
- Figure 3 Drawing of the balloon catheter (1), integrated by a tube of two lumens: one distal and one lateral.
- the distal lumen path allows guidewire advancement to advance valve stent guidance.
- the lateral lumen will allow to inflate the balloon (2) with constant pressure, expanding the polyurethane valve stent (3), with increasing diameters of 12 to 22 mm.
- the balloon 6 is positioned within the stent; then subjected to a reduction in diameter from 22 mm to 5 mm to be conditioned in the catheter.
- a sheath covers the entire length of the catheter to facilitate progression in the peripheral vessels to the heart.
- Figure 3 a The balloon.allowing the expansion with uniform diameter of the stems (1) ⁇ 2 to 3 mm larger expansion of the ring (2), for better fixation in the patient's valve ring, avoiding mobilization or embolization.
- the balloon has been designed to provide an exact diameter of 12 to 22 mm, maintaining a pressure set in accordance with the non-permeable balloon material. Stent valve expansion can be performed with balloons of increasing diameter, following the patient's growth, without the need for replacement of the prosthesis.
- the chosen balloon (12 to 22 mm) is positioned inside the valve stent, while the stent is reduced in diameter by a procedure called crimping, using a device called a crimping mechanism, which has a closing mechanism by means of a crimp. diaphragm, to symmetrically reduce the stent.
- FIG. 4 The drawing shows the release mechanism of the polyurethane valve stent, conditioned in the catheter. After retracting the sheath (1), the valve stent (2) is ready, ready for balloon expansion (3). Radiopaque markings at the ends of the stent and balloon allow placement of the prosthesis in the heart valve ring under treatment.
- FIG. 5 The drawing shows the stent implantation mechanism by balloon expansion (1), using a saline pressure injection, using a pressure syringe or insufflator, which generates pressures from various atmospheres. as the resistance to expansion expands, delivering varying volumes depending on the size of the balloon. Inflation begins immediately after the prosthesis delivery catheter 6 is actuated, expanding the stent rods (2) and opening the polyunethane valve (3). In order to visualize the position of the stent graft and the balloon in the valve ring by X-ray, platinum / iridium radiopaque markers were ligated according to stent length.
- FIG. 6 The use of the Pear Balloon Catheter (1) allows the expansion of the lower stent bonnet (2), turning the mesh for better fixation in the valve ring (3). [026] The possibility of expanding the valve prosthesis, in the late postoperative evolution of the patient, allows this prosthesis to be implanted in children without replacement until the addicted age.
- the expansion procedure can be performed by percutaneous approach, avoiding classical thoracotomy in reoperations for valve replacement, provided that the polyurethane prosthesis remains functional over the years.
- Figure 7 Drawing showing the stenf valve at 4 different times for its clinical use: 12 mm (1), 15 mm (2), 18 mm (3) and 22 mm (4) in diameter.
- Figure 8 Drawing Showing the polyurethane valve stent at 4 different times for its clinical use: 12 mm (1), 15 mm (2), 18 mm (3) and 22 mm (4) in diameter.
- Patients with dysfunctional prosthesis may be submitted to polyurethane valve stent implantation and positioned inside the old prosthesis: Procedure called Implantevaive in vafve.
- the polyurethane valve stent can be implanted into any dysfunctioning heart valve: Mrtral, Tricuspid, Aortic, and Pulmonary, or positioned within tubular prostheses with or without a valve.
Abstract
Patent relating to an expandable polyurethane heart valve prosthesis. Constructed from a malleable stent containing the heart valve prosthesis, formed of three polyurethane strips adhered to fabric with three chromium-cobalt rods, which can be administered inside a catheter and implanted by percutaneous puncture. The polyurethane is applied in liquid state, forming a thin film which will form the three movable strips, without the use of stitches. The known properties of polyurethane for medical use will provide the prosthesis with durability, fatigue strength and resistance to calcification, which are indispensable features for use thereof in pediatric patients. The option of expanding the valve prosthesis, as the patient grows, enables said prothesis to be implanted in children, without the need for replacement until adulthood. The expansion procedure can be performed using a percutaneous approach, without the need for another operation, as long as the polyurethane prosthesis continues working, over the years. The development of said heart valve prosthesis can be considered a sustainable project, as long as it benefits patients, the environment and the popular economy.
Description
"MÉTODO PARA OBTER UM STENT VÁLVULA CARDÍACA EXPANSÍVEL, A "METHOD FOR OBTAINING AN EXPANSIBLE HEART VALVE STENT,
PARTIR DE MEMBRANA DE POLIURETANO E STENT VÁLVULA DE MEMBRANA DE POLIURETANO, PARA FROM POLYURETHANE MEMBRANE AND STENT POLYURETHANE MEMBRANE VALVE TO
IMPLANTE POR CATETER EM PACIENTES ADULTOS E PEDIÁTRICOS". CATHETER IMPLANTS IN ADULT AND PEDIATRIC PATIENTS ".
[001] A presente patente de invenção tem como objetivos principais propor um método indicado a servir de método de obtenção de modelo de stent válvula cardíaca feita a partir de membrana sintética, tipo poliuretano a ser empregada em procedimentos médicos (cirúrgico) tais como os que visam a resolução de problemas de problemas anatómicos e funcionais relacionados as malformações cardíacas e doenças cardíacas adquiridas, em seres humanos, nas seguintes situações: The main object of the present invention is to propose a method indicated to serve as a method of obtaining a cardiac valve stent model made from a synthetic membrane, type polyurethane to be employed in medical (surgical) procedures such as aim to solve problems of anatomical and functional problems related to cardiac malformations and acquired heart disease in humans in the following situations:
[002] Estenose com obstrução parcial das válvulas do coração, comprometendo a abertura da mesma ou obstrução total, caracterizado pela ausência da válvula cardíaca e interferindo na passagem do fluxo sanguíneo. Stenosis with partial obstruction of the heart valves, compromising its opening or total obstruction, characterized by the absence of the heart valve and interfering with the passage of blood flow.
[003] Insuficiência ou ausência congénita de algumas válvulas do coração, com fechamento parcial, comprometendo o fechamento das válvulas cardíacas. [004] Insufficiency or congenital absence of some heart valves, with partial closure, compromising the closing of the heart valves. [004]
É também um dos objetivos da presente invenção, a proteção á prótese cardíaca: "STENT VÁLVULA CARDÍACO [EXPANSÍVEL" contida dentro de um dispositivo (stent) expansível. A prótese e obtida a partir de uma estrutura
de poliuretano, a qual apresenta características desejáveis, tais como: bioestabiiidade e biocompatibtiidade com o organismo receptor, além de ser eficiente e resistente a fadiga, calcificação, trombose e infecção, no sentido de cumprira função biológica da estrutura anatómica natural a que se destina substituir. It is also an object of the present invention to protect the cardiac prosthesis: "STENT [EXPANSIBLE] HEART VALVE" contained within an expandable stent. The prosthesis is obtained from a structure polyurethane, which has desirable characteristics such as: biostability and biocompatibility with the recipient organism, as well as being efficient and resistant to fatigue, calcification, thrombosis and infection, in order to fulfill the biological function of the natural anatomical structure to be replaced. .
1. POLIURETANOS 1.1 Origem e Utilização no mercado. 1. Polyurethanes 1.1 Origin and Market Use.
[005] Em 1848 o químico francês Charles Adolphe Wurtz, descobriu que os grupos Isocianatos reagiam quantitativamente com os grupos hidnoxí/as primárias dando origem a grupos uretanos. Por quase um século essas reaçoes se limitaram a simples experimentos de laboratóricAté que em 1Θ37 o alemão Dr. Otto Bayer e colaboradores levaram o poliuretano à escala industrial. In 1848 French chemist Charles Adolphe Wurtz discovered that the Isocyanate groups reacted quantitatively with the primary hydroxy groups giving rise to urethane groups. For almost a century these reactions were limited to simple laboratory experiments. Until 1Θ37 the German Dr. Otto Bayer and colleagues took polyurethane on an industrial scale.
[006] Atualmente o poliuretano tem sido usado em diversas áreas da industria devido à possibilidade de obter esse polímero com uma grande diversidade de propriedades físicas, sendo possível obter infinitas variações de características, peia combinação de matéria prima diferentes propriedades químicas, como por exemplo, a escolha entre os diversos tipos de isocianatos aromáticos ealiféticos encontrados no mercado. Currently polyurethane has been used in various areas of industry due to the possibility of obtaining this polymer with a great diversity of physical properties, being possible to obtain infinite variations of characteristics, by the combination of different raw material chemical properties, for example, the choice between the various types of aromatic isocyanates found in the market.
1- Matéria prima e preparação de poliuretano (PU) 1- Polyurethane (PU) raw material and preparation
[007] Podemos definir poliuretano comoGrupo de Materiais compostos por macromoléculas confendqá ligação uretano repetidas vezes, geralmente
resultado da reação de isocianato com grupos hidroxílas, ambos dí ou polifuncionais. Veja a seguir a reação genética: [007] We can define polyurethane as Material Group consisting of macromolecules with urethane bonding over and over, usually result of the reaction of isocyanate with hydroxyl groups, both di or polyfunctional. Here's the genetic reaction:
[008] Reação genética de obtenção de poliuretanoA configuração da cadeia depoliuretano pode variar entre regular ou aleatóriajinaar ou cruzada, o que determinara as propriedades físicas do material sintetizado. Por isso deve-se ficar alento aos seguimentos de cadeia quando se deseja obter produtos com propriedades específicas, sendo fatores diretamente ligados ao tipo de matéria prima empregada. [008] Polyurethane Obtaining Genetic ReactionThe polyurethane chain configuration can range from regular or random to junction or cross, which will determine the physical properties of the synthesized material. Therefore one should be encouraged to the chain segments when it is desired to obtain products with specific properties, being factors directly linked to the type of raw material employed.
2- Siant Expansível 2- Siant Expandable
[009] O sistema do stant expansível para implante de prótese valvar cardiaca. [009] The expandable stant system for heart valve prosthesis implantation.
MODELO MODEL
PRÓTESE VALVULAR CARDÍACA EXPANSÍVEL DEEXPANSIBLE HEART VALVE PROSTHESIS
POLIURETANO POLYURETHANE
[010] A presente invenção será descritacom referência as figuras abaixo relacionadas e classificadascomo modelo de "Prótese valvular cardiaca expansível de poliuretano". [010] The present invention will be described with reference to the figures below and classified as a "Expandable Polyurethane Heart Valve Prosthesis" model.
[011] Os desenhos anexados mostram as diferentes etapas na construção da prótese de poliuretano, baseada nas características anatómicas de um estudo de Angio Tomografia Computadorizada da valva aórtica humana.
[012] Figura 1: Desenho do stent: Constituído por uma malha de cromo cobalto, pré-moldado ecortado com laser. Forman parte do stent: anel (1) com 12,5 mm de altura e 3 hastes flexíveis (2) com 12,5 mm de altura, altura total 25 mm. [011] The accompanying drawings show the different steps in the construction of the polyurethane prosthesis, based on the anatomical features of a CT study of the human aortic valve. [012] Figure 1: Stent design: Consisting of a pre-molded, laser-cut cobalt chrome mesh. Forman stent part: ring (1) 12.5 mm high and 3 flexible rods (2) 12.5 mm high, total height 25 mm.
[013] Diâmetro: Em posição "aberta"mantem o mesmo diâmetro uniforme com a sua base de implantação, na estrutura metálica: 22 mm e em posiçãoTechada": 5 mm. [013] Diameter: In the "open" position, maintain the same uniform diameter with its base in the metal frame: 22 mm and in the "Closed" position: 5 mm.
[014] O programa a ser utilizado parao desenho desta prótese, será gerado através de Software Sotid Work; este programa de computador gera uma malha paramétrica e sólida. [014] The program to be used for the design of this prosthesis will be generated through Software Sotid Work; This computer program generates a parametric and solid mesh.
[015] O stent recebe polimento e um banho de polítetrafluoroetileno, para reduzir a chancede formação de trombos.As hastes tem características físicasparticuiares: são flexíveis quando submetidas a passagem defluxo de fluidos a pressão, reduzindo o desgaste damembrana aplicada sobre o stent. [015] The stent receives polishing and a polytetrafluoroethylene bath to reduce the chance of thrombus formation. The stems have particle physical characteristics: they are flexible when subjected to fluid flow under pressure, reducing the wear of the membrane applied over the stent.
[016] Figura 2: Desenho do stent válvula: Uma fina membrana de poliuretano (1), de 0,2 a 0,3 mm foi aplicada sobre ostent formando três cúspides flexíveis, sem uso de suturas ecom mecanismo de abertura máxima igual ao diâmetro maior do stent 22 mm e fechamento hermético no nível da base das hastes, imitando as válvulas sigmoideas aórtica e pulmonar humanas. Existe um limite de aplicação do poliuretano (2), há 6 mm da borda inferior do stent, mantendo este segmento da malha de cromo cobalto (3) livre de poliuretano, expondo uma superfície apta para a fixação do stent no anel valvular do paciente.
[017] Figura 3: Desenho do Cateter balão(1), integrado por um tubo de dois lúmens: um distai e outro lateral. A via do lúmen distai, permite o avanço do fio guia, pára avançar o guiar do stent válvula. O lúmen lateral permitirá insuflar o balão (2), com pressão constante, expandindo o stent válvula de poliuretano (3), com diâmetros crescentes de 12 a 22 mm. [016] Figure 2: Valve stent design: A thin 0.2 to 0.3 mm polyurethane membrane (1) was applied over the ostentate forming three flexible cusps without the use of sutures and a maximum opening mechanism equal to the diameter. larger stent 22 mm and hermetic closure at the base of the stems, mimicking the human aortic and pulmonary sigmoid valves. There is a limit of application of polyurethane (2), 6 mm from the lower edge of the stent, keeping this segment of the cobalt chrome mesh (3) free of polyurethane, exposing a surface suitable for stent attachment in the patient's valve annulus. [017] Figure 3: Drawing of the balloon catheter (1), integrated by a tube of two lumens: one distal and one lateral. The distal lumen path allows guidewire advancement to advance valve stent guidance. The lateral lumen will allow to inflate the balloon (2) with constant pressure, expanding the polyurethane valve stent (3), with increasing diameters of 12 to 22 mm.
[018] O balão 6 posicionado dentro do stent; a seguir submetido a redução do seu diâmetro de 22 mm para 5 mm, para ser condicionado no cateter. Uma vainha cobre toda a extensão do cateter para facilitar a progressão nos vasos periféricos, até o coração. The balloon 6 is positioned within the stent; then subjected to a reduction in diameter from 22 mm to 5 mm to be conditioned in the catheter. A sheath covers the entire length of the catheter to facilitate progression in the peripheral vessels to the heart.
[019] Figura 3 a: O balão.permrtindo a expansão com diâmetro uniforme das hastes (1) ø expansão de 2 a 3 mm maior do anel (2), para melhor fixaçãono anel valvar do paciente, evitando mobilização ou embolização. [019] Figure 3 a: The balloon.allowing the expansion with uniform diameter of the stems (1) ø 2 to 3 mm larger expansion of the ring (2), for better fixation in the patient's valve ring, avoiding mobilization or embolization.
[020] O balão foi concebido paraproporcionar diâmetro exato de 12 a 22 mm, mantendopressão estabelecida de acordo com o material do balãosemidefbrmável. A expansão do stent válvula, pode ser realizado com balões de diâmetro crescente, acompanhando o crescimento do paciente, sem a necessidade de substituição da prótese. [020] The balloon has been designed to provide an exact diameter of 12 to 22 mm, maintaining a pressure set in accordance with the non-permeable balloon material. Stent valve expansion can be performed with balloons of increasing diameter, following the patient's growth, without the need for replacement of the prosthesis.
[021] O balão escolhido (12 até 22 mm) é posicionado dentro do stent válvula, enquanto o stent é submetido a redução do seu diâmetro, mediante o procedimento chamado de crimpagem, utilizando um equipamento denominado crimpador, que possui um mecanismo de fechamento mediante diafragma, para reduzir simetricamente o stent.
FUNCIONAMENTO DE MECANISMO DO STENT VÁLVULA DE POLIURETANO [021] The chosen balloon (12 to 22 mm) is positioned inside the valve stent, while the stent is reduced in diameter by a procedure called crimping, using a device called a crimping mechanism, which has a closing mechanism by means of a crimp. diaphragm, to symmetrically reduce the stent. STENT MECHANISM OPERATION OF POLYURETHANE VALVE
[022] Figura 4: O desenho mostrao mecanismo de liberação do stent válvula de poliuretano, condicionado no cateter. Após recuar a vainha (1), fica exposto o stent válvula (2), pronto para a expansão do balão (3). Marcas radiopacas nos extremos do stent e do balão permitem posicionar a prótese no anel da válvula cardíaca em tratamento. [022] Figure 4: The drawing shows the release mechanism of the polyurethane valve stent, conditioned in the catheter. After retracting the sheath (1), the valve stent (2) is ready, ready for balloon expansion (3). Radiopaque markings at the ends of the stent and balloon allow placement of the prosthesis in the heart valve ring under treatment.
(023] Figura 5: O desenho mostra o mecanismo de implante do stent, mediante a expansão do balão (1), utilizando uma injeção à pressão de soro fisiológico, mediante o uso de seringa de pressão ou insuflador, que gera pressões de várias atmosferas, conforme a resistência imposta a expansão, entregando volumes variáveis, conformeo tamanho do balão. A insuflação começa imediatamente após o cateter de entrega da prótese 6 acionado, expandindo as hastes do stent (2) e abrindo a válvula de poliunetano(3). A fim de visualizar a posição da endoprótese e o balão no anel valvar por raios X, marcadores radiopacos de platina / irídio foram ligados de acordo com o comprimento do stent (023] Figure 5: The drawing shows the stent implantation mechanism by balloon expansion (1), using a saline pressure injection, using a pressure syringe or insufflator, which generates pressures from various atmospheres. as the resistance to expansion expands, delivering varying volumes depending on the size of the balloon. Inflation begins immediately after the prosthesis delivery catheter 6 is actuated, expanding the stent rods (2) and opening the polyunethane valve (3). In order to visualize the position of the stent graft and the balloon in the valve ring by X-ray, platinum / iridium radiopaque markers were ligated according to stent length.
[024] Dois marcadores adicionais sobre a haste do cateter proximal foram colocados para ajudar a posicionar o cateter de dilatação, no anel valvar do paciento (4), em relação a ponta cateter guia (5). [024] Two additional markers on the proximal catheter shaft were placed to help position the dilating catheter in the patient's valve ring (4) relative to the guide catheter tip (5).
[025] Figura 6: O emprego de Cateter Balão em forma de Pera (1), permite a expansão da bonda inferior do stent (2), virando a malha para melhor fixação no anel valvar (3).
[026] A possibilidade de expandir a prótese valvar, na evolução pos- opertória tardia do paciente, permite que esta prótese seja implantada em crianças, sem necessidade de substituição, até a idade adutta. [025] Figure 6: The use of the Pear Balloon Catheter (1) allows the expansion of the lower stent bonnet (2), turning the mesh for better fixation in the valve ring (3). [026] The possibility of expanding the valve prosthesis, in the late postoperative evolution of the patient, allows this prosthesis to be implanted in children without replacement until the addicted age.
[027] O procedimento de expansão pode ser realizado mediante a abordagem percutânea, evitando a toracotomia clássica, nas reoperações para substituição valvar, desde que a prótese de poliuretano se mantenha funcionante com o passar dos anos. [027] The expansion procedure can be performed by percutaneous approach, avoiding classical thoracotomy in reoperations for valve replacement, provided that the polyurethane prosthesis remains functional over the years.
[028] Figura 7: Desenho mostrando o stenf válvula, em 4 momentos diferentes para sua utilização clínica: 12 mm (1), 15 mm (2), 18 mm (3) e 22 mm (4) de diâmetro. [028] Figure 7: Drawing showing the stenf valve at 4 different times for its clinical use: 12 mm (1), 15 mm (2), 18 mm (3) and 22 mm (4) in diameter.
[029] Figura 8: Desenho Mostrando o stent válvula de poliuretano, em 4 momentos diferentes para seu uso clinico: 12 mm (1), 15 mm (2), 18 mm (3) e 22 mm (4) de diâmetro. [029] Figure 8: Drawing Showing the polyurethane valve stent at 4 different times for its clinical use: 12 mm (1), 15 mm (2), 18 mm (3) and 22 mm (4) in diameter.
[030] Indicações: Paciente com prótese com disfunção poderão ser submetidos a implante de stent válvula de poliuretano, sendo posicionando por dentro da prótese antiga: Procedimento denominado Implantevaive in vafve. O stent válvula de poliuretano pode ser implantado em qualquerposição das válvulas cardíacas que apresentem disfunção:Mrtral, Tricúspide, Aórtica e Pulmonar, ou posicionado dentro de próteses tubulares com ou sem válvula. [030] Indications: Patients with dysfunctional prosthesis may be submitted to polyurethane valve stent implantation and positioned inside the old prosthesis: Procedure called Implantevaive in vafve. The polyurethane valve stent can be implanted into any dysfunctioning heart valve: Mrtral, Tricuspid, Aortic, and Pulmonary, or positioned within tubular prostheses with or without a valve.
[031] Trata-se de um Projeto Sustentável: beneficiando aos Pacientes: Será oferecida uma prótese confiável, duradoura, com menor risco de disfunçao,para implante em adultos e crianças, mediante um procedimento mais simples, menor risco cirúrgico. Menortempo de permanência em UTI, e
Intemação Hospitalar. [031] This is a Sustainable Project: benefiting Patients: A reliable, durable, lower risk of dysfunction prosthesis will be offered for implantation in adults and children through a simpler procedure and lower surgical risk. Shortest ICU stay, and Hospital Information.
[032] Meio Ambiente: Não será necessário a manipulação de tecido animal, nem soluções químicas para a preservação da prótese, que será esterilizada com Radiação Gama. [032] Environment: No manipulation of animal tissue or chemical solutions will be necessary to preserve the prosthesis, which will be sterilized with Gamma Radiation.
[033] Produto Económico: A fabricação pode realizar-se em grande escala, portanto de baixo custo e de grande valor agregado. [033] Economic Product: Manufacturing can be carried out on a large scale, therefore of low cost and high added value.
[034] Valor Cientifico: Poderão ser fabricados vários modelos diferentes, conforme as necessidades de cada paciente. [034] Scientific Value: Several different models can be manufactured according to the needs of each patient.
[035] Satisfação Social: trata-se de um produto nacional, avaliado pelo método científico (Cirurgia Experimental) e podendo obter certificação na ANVISA, para colocá-lo ao alcance de qualquer cidadão.
[035] Social Satisfaction: It is a national product, evaluated by the scientific method (Experimental Surgery) and can obtain certification by ANVISA, to make it available to any citizen.
Claims
(1) e expansão de 2 a 3 mm maior do anei (2), para melhor frxação no anel valvar do paciente, evitando mobilização ou embolização. O balão foi concebido para proporcionar diâmetro exato de 12 a 22 mm, mantendo pressão estabelecida de acordo com o material do balão semideforrnãvel. A expansão do stent válvula, pode ser realizado com balões de diâmetro crescente, acompanhando o crescimento do paciente, sem a necessidade de substituição da prótese. O mecanismo de liberação do stent válvula de poliuretano, condicionado no cateter. Após recuar a vainha (Figura 4) (1), fica exposto o stent válvula (2), pronto para a expansão do balão (3). Marcas radiopacas nos extremos do stent e do balão permitem posicionar a prótese no anei da válvula cardíaca em tratamento. O cateter balão (Figura 5) em forma de pera (1), permite a expansão da borda inferior do stent (Figura 8)(1) and 2 to 3 mm greater expansion of the ring (2), for better flxation on the patient's valve ring, avoiding mobilization or embolization. The balloon was designed to provide an exact diameter of 12 to 22 mm, maintaining an established pressure according to the material of the semi-deformable balloon. Expansion of the valve stent can be performed with balloons of increasing diameter, following the patient's growth, without the need to replace the prosthesis. The stent release mechanism is a polyurethane valve, conditioned in the catheter. After withdrawing the vane (Figure 4) (1), the valve stent (2) is exposed, ready for balloon expansion (3). Radiopaque marks at the ends of the stent and balloon allow positioning the prosthesis in the ring of the heart valve being treated. The pear-shaped balloon catheter (Figure 5) (1) allows expansion of the lower edge of the stent (Figure 8)
(2) , virando externamente a malha para melhor fixação no anel vaivar (3), evitando movimentação, rotação ou embolização. Os stents podem ser expandidos com diâmetros de: (Figura 7) 12 mm (1), 15 mm (2), 18 mm (3) e 22 mm (4), assim como os stent válvula de poliuretano, para seu uso clínico, com diâmetros: (Figura 8), 12 mm (1), 15 mm (2), 18 mm (3) e 22 mm (4).Trata- se de um Projeto Sustentável: beneficiando aos Pacientes: Será oferecida uma prótese confiávef, duradoura, com menor risco de
disfunção, para implante em adultos e crianças, mediante um procedimento mais simples, menor risco cirúrgico. Menor tempo de permanência em UTI, e Internação Hospitalar. Meio Ambiente: Não será necessário a manipulação de tecido animal, nem soluções químicas para a preservação da prótese, que será esterilizada com Radiação Gama. Produto Económico: A fabricação pode realizar-se em grande escala, portanto de baixo custo e de grande valor agregado. Valor Científico: Poderão ser fabricados vários modelos diferentes, conforme as necessidades de cada paciente. Satisfação Social: trata-se de um produto nacional, avaliado pelo método científico (Cirurgia Experimental) e podendo obter certificação na AN VI SA, para colocá-lo ao alcance de qualquer cidadão.
(2) , externally turning the mesh for better fixation in the vaivar ring (3), avoiding movement, rotation or embolization. The stents can be expanded with diameters of: (Figure 7) 12 mm (1), 15 mm (2), 18 mm (3) and 22 mm (4), as well as the polyurethane valve stent, for clinical use, with diameters: (Figure 8), 12 mm (1), 15 mm (2), 18 mm (3) and 22 mm (4). This is a Sustainable Project: benefiting Patients: A reliable prosthesis will be offered, lasting, with lower risk of dysfunction, for implantation in adults and children, through a simpler procedure, lower surgical risk. Shorter length of stay in the ICU and hospital stay. Environment: It will not be necessary to manipulate animal tissue or chemical solutions to preserve the prosthesis, which will be sterilized with Gamma Radiation. Economical Product: Manufacturing can be carried out on a large scale, therefore low cost and with great added value. Scientific Value: Several different models can be manufactured, depending on the needs of each patient. Social Satisfaction: this is a national product, evaluated using the scientific method (Experimental Surgery) and capable of obtaining certification from AN VI SA, to make it within the reach of any citizen.
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BR102016021508-0A BR102016021508A2 (en) | 2016-09-19 | 2016-09-19 | METHOD FOR OBTAINING AN EXPANSIBLE HEART VALVE STENT FROM POLYURETHANE MEMBRANE AND STENT POLYURETHANE MEMBRANE VALVE FOR CATHETER IMPLANTS IN ADULT AND PEDIATRIC PATIENTS |
BRBR1020160215080 | 2016-09-19 |
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WO2018049492A1 true WO2018049492A1 (en) | 2018-03-22 |
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PCT/BR2017/000078 WO2018049492A1 (en) | 2016-09-19 | 2017-07-17 | Method for producing an expandable heart valve stent from a polyurethane membrane and polyurethane membrane valve stent that can be implanted using a catheter in adult and pediatric patients |
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WO2023060330A1 (en) * | 2021-10-15 | 2023-04-20 | Angel Maluf Miguel | Polyurethane-coated, expandable stented valve prosthesis designed with anatomic cusps for implanting by catheter in the pulmonary position in pediatric and adult patients, and method for producing expandable stented valve prosthesis |
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US4222126A (en) * | 1978-12-14 | 1980-09-16 | The United States Of America As Represented By The Secretary Of The Department Of Health, Education & Welfare | Unitized three leaflet heart valve |
US5411552A (en) * | 1990-05-18 | 1995-05-02 | Andersen; Henning R. | Valve prothesis for implantation in the body and a catheter for implanting such valve prothesis |
US20060276813A1 (en) * | 2005-05-20 | 2006-12-07 | The Cleveland Clinic Foundation | Apparatus and methods for repairing the function of a diseased valve and method for making same |
US20070270944A1 (en) * | 2004-04-23 | 2007-11-22 | 3F Therapeutics, Inc. | Implantable Valve Prosthesis |
US20110264207A1 (en) * | 2008-02-28 | 2011-10-27 | Phillip Bonhoeffer | Prosthetic heart valve systems |
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WO2014179782A1 (en) * | 2013-05-03 | 2014-11-06 | Medtronic Inc. | Prosthetic valves and associated appartuses, systems and methods |
US20150196688A1 (en) * | 2012-03-12 | 2015-07-16 | Colorado State University Research Foundation | Glycosaminoglycan and Synthetic Polymer Material for Blood-Contacting Applications |
US20150366664A1 (en) * | 2014-06-20 | 2015-12-24 | Edwards Lifesciences Corporation | Surgical heart valves identifiable post-implant |
BR102015032289A2 (en) * | 2015-12-22 | 2017-06-27 | Universidade Federal De São Paulo-Unifesp | STENT EXPANSIBLE VALVE |
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2016
- 2016-09-19 BR BR102016021508-0A patent/BR102016021508A2/en not_active Application Discontinuation
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US4222126A (en) * | 1978-12-14 | 1980-09-16 | The United States Of America As Represented By The Secretary Of The Department Of Health, Education & Welfare | Unitized three leaflet heart valve |
US5411552A (en) * | 1990-05-18 | 1995-05-02 | Andersen; Henning R. | Valve prothesis for implantation in the body and a catheter for implanting such valve prothesis |
US20070270944A1 (en) * | 2004-04-23 | 2007-11-22 | 3F Therapeutics, Inc. | Implantable Valve Prosthesis |
US20060276813A1 (en) * | 2005-05-20 | 2006-12-07 | The Cleveland Clinic Foundation | Apparatus and methods for repairing the function of a diseased valve and method for making same |
US20110264207A1 (en) * | 2008-02-28 | 2011-10-27 | Phillip Bonhoeffer | Prosthetic heart valve systems |
US20120296418A1 (en) * | 2011-05-20 | 2012-11-22 | Edwards Lifesciences Corporation | Encapsulated heart valve |
US20150196688A1 (en) * | 2012-03-12 | 2015-07-16 | Colorado State University Research Foundation | Glycosaminoglycan and Synthetic Polymer Material for Blood-Contacting Applications |
WO2014179782A1 (en) * | 2013-05-03 | 2014-11-06 | Medtronic Inc. | Prosthetic valves and associated appartuses, systems and methods |
US20150366664A1 (en) * | 2014-06-20 | 2015-12-24 | Edwards Lifesciences Corporation | Surgical heart valves identifiable post-implant |
BR102015032289A2 (en) * | 2015-12-22 | 2017-06-27 | Universidade Federal De São Paulo-Unifesp | STENT EXPANSIBLE VALVE |
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WO2023060330A1 (en) * | 2021-10-15 | 2023-04-20 | Angel Maluf Miguel | Polyurethane-coated, expandable stented valve prosthesis designed with anatomic cusps for implanting by catheter in the pulmonary position in pediatric and adult patients, and method for producing expandable stented valve prosthesis |
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