DE19904913A1 - Flexible polymer heart valve with modified surface to inhibit calcification in vivo - Google Patents
Flexible polymer heart valve with modified surface to inhibit calcification in vivoInfo
- Publication number
- DE19904913A1 DE19904913A1 DE1999104913 DE19904913A DE19904913A1 DE 19904913 A1 DE19904913 A1 DE 19904913A1 DE 1999104913 DE1999104913 DE 1999104913 DE 19904913 A DE19904913 A DE 19904913A DE 19904913 A1 DE19904913 A1 DE 19904913A1
- Authority
- DE
- Germany
- Prior art keywords
- heart valve
- flexible
- modified polymer
- heart
- valve
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Withdrawn
Links
- 210000003709 heart valve Anatomy 0.000 title claims abstract description 47
- 229920005570 flexible polymer Polymers 0.000 title abstract description 7
- 230000002308 calcification Effects 0.000 title description 8
- 238000001727 in vivo Methods 0.000 title 1
- 238000005468 ion implantation Methods 0.000 claims abstract description 10
- 229910052799 carbon Inorganic materials 0.000 claims abstract description 6
- OKTJSMMVPCPJKN-UHFFFAOYSA-N Carbon Chemical compound [C] OKTJSMMVPCPJKN-UHFFFAOYSA-N 0.000 claims abstract description 5
- 238000002513 implantation Methods 0.000 claims abstract description 4
- 239000000463 material Substances 0.000 claims abstract description 4
- XOAAWQZATWQOTB-UHFFFAOYSA-N taurine Chemical compound NCCS(O)(=O)=O XOAAWQZATWQOTB-UHFFFAOYSA-N 0.000 claims abstract 6
- 230000004048 modification Effects 0.000 claims abstract 4
- 238000012986 modification Methods 0.000 claims abstract 4
- 239000000126 substance Substances 0.000 claims abstract 4
- WYTZZXDRDKSJID-UHFFFAOYSA-N (3-aminopropyl)triethoxysilane Chemical compound CCO[Si](OCC)(OCC)CCCN WYTZZXDRDKSJID-UHFFFAOYSA-N 0.000 claims abstract 3
- HTTJABKRGRZYRN-UHFFFAOYSA-N Heparin Chemical compound OC1C(NC(=O)C)C(O)OC(COS(O)(=O)=O)C1OC1C(OS(O)(=O)=O)C(O)C(OC2C(C(OS(O)(=O)=O)C(OC3C(C(O)C(O)C(O3)C(O)=O)OS(O)(=O)=O)C(CO)O2)NS(O)(=O)=O)C(C(O)=O)O1 HTTJABKRGRZYRN-UHFFFAOYSA-N 0.000 claims abstract 3
- 229960002897 heparin Drugs 0.000 claims abstract 3
- 229920000669 heparin Polymers 0.000 claims abstract 3
- 229960003080 taurine Drugs 0.000 claims abstract 3
- 238000000034 method Methods 0.000 claims abstract 2
- 229910010271 silicon carbide Inorganic materials 0.000 claims abstract 2
- 229920000642 polymer Polymers 0.000 claims description 13
- 238000009499 grossing Methods 0.000 claims 3
- 238000000576 coating method Methods 0.000 claims 1
- 238000007654 immersion Methods 0.000 claims 1
- 229920002635 polyurethane Polymers 0.000 claims 1
- 239000004814 polyurethane Substances 0.000 claims 1
- 238000005498 polishing Methods 0.000 abstract 2
- 239000000560 biocompatible material Substances 0.000 abstract 1
- HBMJWWWQQXIZIP-UHFFFAOYSA-N silicon carbide Chemical compound [Si+]#[C-] HBMJWWWQQXIZIP-UHFFFAOYSA-N 0.000 abstract 1
- 238000011161 development Methods 0.000 description 2
- 230000018109 developmental process Effects 0.000 description 2
- 150000002500 ions Chemical class 0.000 description 2
- 241000282412 Homo Species 0.000 description 1
- 206010038743 Restlessness Diseases 0.000 description 1
- 108010064129 Thrombogen Proteins 0.000 description 1
- 208000007536 Thrombosis Diseases 0.000 description 1
- 210000001765 aortic valve Anatomy 0.000 description 1
- 230000003385 bacteriostatic effect Effects 0.000 description 1
- 230000015572 biosynthetic process Effects 0.000 description 1
- 238000003763 carbonization Methods 0.000 description 1
- 238000010000 carbonizing Methods 0.000 description 1
- 230000004154 complement system Effects 0.000 description 1
- 230000001408 fungistatic effect Effects 0.000 description 1
- 238000010849 ion bombardment Methods 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 210000004115 mitral valve Anatomy 0.000 description 1
- 238000005457 optimization Methods 0.000 description 1
- 210000000056 organ Anatomy 0.000 description 1
- 230000002093 peripheral effect Effects 0.000 description 1
- 239000005871 repellent Substances 0.000 description 1
- 210000000591 tricuspid valve Anatomy 0.000 description 1
Classifications
-
- C—CHEMISTRY; METALLURGY
- C23—COATING METALLIC MATERIAL; COATING MATERIAL WITH METALLIC MATERIAL; CHEMICAL SURFACE TREATMENT; DIFFUSION TREATMENT OF METALLIC MATERIAL; COATING BY VACUUM EVAPORATION, BY SPUTTERING, BY ION IMPLANTATION OR BY CHEMICAL VAPOUR DEPOSITION, IN GENERAL; INHIBITING CORROSION OF METALLIC MATERIAL OR INCRUSTATION IN GENERAL
- C23C—COATING METALLIC MATERIAL; COATING MATERIAL WITH METALLIC MATERIAL; SURFACE TREATMENT OF METALLIC MATERIAL BY DIFFUSION INTO THE SURFACE, BY CHEMICAL CONVERSION OR SUBSTITUTION; COATING BY VACUUM EVAPORATION, BY SPUTTERING, BY ION IMPLANTATION OR BY CHEMICAL VAPOUR DEPOSITION, IN GENERAL
- C23C14/00—Coating by vacuum evaporation, by sputtering or by ion implantation of the coating forming material
- C23C14/22—Coating by vacuum evaporation, by sputtering or by ion implantation of the coating forming material characterised by the process of coating
- C23C14/48—Ion implantation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/14—Macromolecular materials
- A61L27/18—Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L27/507—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials for artificial blood vessels
-
- 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
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2400/00—Materials characterised by their function or physical properties
- A61L2400/12—Nanosized materials, e.g. nanofibres, nanoparticles, nanowires, nanotubes; Nanostructured surfaces
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2400/00—Materials characterised by their function or physical properties
- A61L2400/18—Modification of implant surfaces in order to improve biocompatibility, cell growth, fixation of biomolecules, e.g. plasma treatment
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Epidemiology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Veterinary Medicine (AREA)
- Dermatology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Vascular Medicine (AREA)
- Engineering & Computer Science (AREA)
- Materials Engineering (AREA)
- Mechanical Engineering (AREA)
- Metallurgy (AREA)
- Organic Chemistry (AREA)
- Prostheses (AREA)
- Materials For Medical Uses (AREA)
Abstract
Description
Die Erfindung bezieht sich auf eine flexible Polymer-Carbon Herzklappe zum Ersatz einer Herzklappe im menschlichen Herzen, insbesondere der Mitral-, Aorten- und Tricuspidalklappe.The invention relates to a flexible polymer-carbon heart valve to replace a heart valve in the human heart, especially the Mitral, aortic and tricuspid valve.
Die Geschichte der künstlichen Herzklappe überdeckt heute bereits eine Periode von mehr als 47 Jahren und beginnt mit der ersten von Hufnagel im Jahre 1952 implantierten Herzklappe. Dennoch sind die Entwicklungen- und Optimierungsprobleme künstlicher (mechanische sowie Polymerklappen) Herzklappen noch nicht vollständig gelöst, wie allein schon aus der großen Zahl der gegenwärtig gebräuchlichen Klappentypen hervorgeht.The history of the artificial heart valve already covers one Period of more than 47 years and begins with the first of Hufnagel in 1952 implanted heart valve. Nevertheless, the developments and Optimization problems of artificial (mechanical and polymer flaps) Heart valves have not yet been completely released, as is the case with the large one Number of currently used valve types is shown.
Zur Zeit beherrschen mechanische Herzklappen das Feld, wobei in den letzten Jahren auch die flexiblen Herzklappen an Bedeutung gewinnen, aber noch nicht im Menschen dauerhaft eingesetzt wurden. In den Patent-, Offenlegungs- oder Auslegungsschriften US2929804, WO83/03974, US4247292, US4222127, US4364127, EP0193987, DE 34 06 231, EP0114025, DE 23 55 959, EP0224153, DE 35 41 478 und EP0363753 werden die verschiedenartigsten Geometrien und Segelhalterungen sowie die verschiedensten Herstellungsverfahren angegeben. Die bisher erzielten Ergebnisse sind jedoch nicht zufriedenstellend. So liegt bei allen zur Zeit auf dem Markt befindlichen flexiblen Herzklappen die gleiche Problematik der Kalzifizierung der Herzklappenflügel vor; dieses Kalzifizierungsproblem ist schon seit mehreren Jahren bekannt und auch in neueren Untersuchungen nachzulesen, z. B. im Internationalen Journal of Artificial Organs/Vol.21/no 12, 1998 pp.814-819.Mechanical heart valves currently dominate the field In recent years, flexible heart valves have also become more important, but have not yet been used permanently in humans. In the patent, laid-open or interpretation documents US2929804, WO83 / 03974, US4247292, US4222127, US4364127, EP0193987, DE 34 06 231, EP0114025, DE 23 55 959, EP0224153, DE 35 41 478 and EP0363753 different geometries and Sail holders as well as the most diverse manufacturing processes specified. However, the results achieved so far are not satisfactory. So lies with all those currently on the market flexible heart valves the same problem of calcification of the Heart valve wing in front; this calcification problem has been around known for several years and can also be read in recent studies, e.g. B. in the International Journal of Artificial Organs / Vol. 21 / no 12, 1998 pp.814-819.
Die bisher eingesetzten Polymere sind zwar biokompatibel, jedoch haben die Klappensegel nicht die erforderliche Oberflächengüte, denn unruhige und poröse Oberflächen bieten eine breite Angriffsfläche zur Kalzifizierung und gegenüber Thromben. Diese Oberflächen erhöhen damit das Risiko eines Herzklappenversagens durch Kalzifizierung. Glatte Oberflächen hingegen wirken weniger kalzifizierend und trombogen, da sie weniger Ansatzpunkte bieten, das menschliche Komplement-System zu aktivieren. The polymers used so far are biocompatible, however the flap sails do not have the required surface quality, because restless and porous surfaces offer a wide contact surface for calcification and against thrombi. Increase these surfaces thus the risk of heart valve failure due to calcification. Smooth surfaces, on the other hand, are less calcifying and thrombogen, since they offer fewer starting points, the human Activate complement system.
Der vorliegenden Erfindung lag die Aufgabe zugrunde, die Oberflächen der flexiblen Herzklappe (Klappensegel) so zu optimieren, daß die oben genannte Problematik der Kalzifizierung entschieden verringert bzw. ganz beseitigt wird, desweiteren eine Oberfläche zu schaffen, die eine bessere Bio-Haemokompatibilität für den Einsatz als flexible Herzklappe aufweist.The present invention was based, the surfaces of the flexible heart valve (valve leaflet) so that the above The problem of calcification mentioned is significantly reduced or entirely is eliminated, furthermore to create a surface that is better Has bio-hemocompatibility for use as a flexible heart valve.
Diese Aufgabe wird erfindungsgemäß dadurch gelöst, daß die gesamte Oberfläche einer fertig hergestellten flexiblen Herzklappe mittels Plasma- Ionenimplantation carbonisiert wird; gleichzeitig erreicht man, daß die Oberfläche durch den Carbon-Ionenbeschuß poliert wird, um so eine mikroskopisch geglättete Oberfläche zu erhalten.This object is achieved in that the entire Surface of a finished flexible heart valve using plasma Ion implantation is carbonized; at the same time you achieve that Surface is polished by the carbon ion bombardment, so one to obtain a microscopically smoothed surface.
Die Plasma-Ionenimplantation ist eine neuere Entwicklung zur schnellen und allseitigen Implantation von Ionen in beliebig geformten Werkstücken oder Bauteilen. Bei ihr wird das zu implantierende Werkstück (flexible polymere Herzklappe) in ein Plasma eingetaucht. Durch das Anlegen einer negativen Hochspannung an das Werkstück (flexible polymere Herzklappe) werden positiv geladene Ionen aus der Randschicht des Plasmas extrahiert und allseitig auf das Werkstück (flexible polymere Herzklappe) hin beschleunigt und in die gesamte Oberfläche gleichzeitig implantiert.The plasma ion implantation is a newer development for fast and All-round implantation of ions in workpieces of any shape or Components. The workpiece to be implanted (flexible polymer Heart valve) immersed in a plasma. By creating a negative High tension on the workpiece (flexible polymeric heart valve) positively charged ions extracted from the peripheral layer of the plasma and accelerated on all sides towards the workpiece (flexible polymeric heart valve) and implanted in the entire surface at the same time.
Die Carbonisierung ist untrennbar mit dem Polymer verbunden. Dadurch bedingt bleiben die so erfindungsgemäße neue Herzklappenoberfläche immer mikroskopisch glatt. Durch die Carbonisierung der Herzklappe wird ein Material eingesetzt (Carbon), das sich schon vielfach in der medizinischen Anwendung bewährt hat (z. B. mechanische Herzklappen), aber bei polymeren Herzklappenprothesen noch keine Anwendung fand. Bei Untersuchungen wurde gezeigt, daß die carbonisierte und mikroskopisch geglättete modifizierte Herzklappenoberfläche (mittels PII-Plasma- Ionenimplantation) thromboresistent, bakteriostatisch, haemocompatibel, mineralabweisend, fungostatisch, glatt und beständig ist, insbesondere daß keine Kalzifizierung auf dem Material nachgewiesen werden konnte. Carbonization is inextricably linked to the polymer. Thereby the new heart valve surface according to the invention thus always remains conditional microscopically smooth. By carbonizing the heart valve a material used (carbon) that is already widely used in the has proven medical application (e.g. mechanical heart valves), but has not yet been used in polymeric heart valve prostheses. Research has shown that the carbonized and microscopic smoothed modified heart valve surface (using PII plasma Ion implantation) thromboresistant, bacteriostatic, hemocompatible, mineral-repellent, fungostatic, smooth and durable, especially that no calcification could be demonstrated on the material.
Die so erfindungsgemäße modifizierte flexible Herzklappe reduziert die Kalzifizierungsgefahr auf ein Minimum, die Haftung von Blutplättchen und damit die Gefahr der Thrombenbildung werden entschieden verringert. Es zeigt sich also, daß die erfindungsgemäße modifizierte flexible Herzklappe wesentlich bessere Eigenschaften besitzt als die bisher eingesetzten flexiblen PU-Herzklappen.The modified flexible heart valve according to the invention thus reduces the Risk of calcification to a minimum, the adhesion of platelets and thus the risk of thrombus formation are decidedly reduced. It shows that the modified flexible heart valve according to the invention has much better properties than those previously used flexible PU heart valves.
Claims (9)
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DE1999104913 DE19904913A1 (en) | 1999-02-06 | 1999-02-06 | Flexible polymer heart valve with modified surface to inhibit calcification in vivo |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DE1999104913 DE19904913A1 (en) | 1999-02-06 | 1999-02-06 | Flexible polymer heart valve with modified surface to inhibit calcification in vivo |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| DE19904913A1 true DE19904913A1 (en) | 1999-09-16 |
Family
ID=7896676
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DE1999104913 Withdrawn DE19904913A1 (en) | 1999-02-06 | 1999-02-06 | Flexible polymer heart valve with modified surface to inhibit calcification in vivo |
Country Status (1)
| Country | Link |
|---|---|
| DE (1) | DE19904913A1 (en) |
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP1252902A1 (en) * | 2001-04-23 | 2002-10-30 | Riken | Artificial dura mater having cell adhesiveness and a process for producing the same |
| DE10306443A1 (en) * | 2003-02-17 | 2004-09-09 | Lothar Sellin | Self-expanding stent with a holding system for the cusp of a polyurethane heart valve is provided with integral bypasses |
| WO2007022174A2 (en) | 2005-08-18 | 2007-02-22 | Boston Scientific Scimed, Inc. | Surface modification of eptfe and implants using the same |
| WO2017158148A1 (en) | 2016-03-17 | 2017-09-21 | Centro Cardiologico Monzino | Polymers and uses thereof in manufacturing of 'living' heart valves |
-
1999
- 1999-02-06 DE DE1999104913 patent/DE19904913A1/en not_active Withdrawn
Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP1252902A1 (en) * | 2001-04-23 | 2002-10-30 | Riken | Artificial dura mater having cell adhesiveness and a process for producing the same |
| US6872759B2 (en) | 2001-04-23 | 2005-03-29 | Riken | Artificial dura mater having cell adhesiveness and a process for producing the same |
| DE10306443A1 (en) * | 2003-02-17 | 2004-09-09 | Lothar Sellin | Self-expanding stent with a holding system for the cusp of a polyurethane heart valve is provided with integral bypasses |
| WO2007022174A2 (en) | 2005-08-18 | 2007-02-22 | Boston Scientific Scimed, Inc. | Surface modification of eptfe and implants using the same |
| WO2007022174A3 (en) * | 2005-08-18 | 2007-06-21 | Boston Scient Scimed Inc | SURFACE MODIFICATION OF ePTFE AND IMPLANTS USING THE SAME |
| US7597924B2 (en) | 2005-08-18 | 2009-10-06 | Boston Scientific Scimed, Inc. | Surface modification of ePTFE and implants using the same |
| WO2017158148A1 (en) | 2016-03-17 | 2017-09-21 | Centro Cardiologico Monzino | Polymers and uses thereof in manufacturing of 'living' heart valves |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| OAV | Applicant agreed to the publication of the unexamined application as to paragraph 31 lit. 2 z1 | ||
| OR8 | Request for search as to paragraph 43 lit. 1 sentence 1 patent law | ||
| 8105 | Search report available | ||
| 8139 | Disposal/non-payment of the annual fee |