DE3941873A1 - Hollow fibres coated which cells with inhibit coagulation - for long-term use as implants in arteries and veins to carry sensors - Google Patents

Hollow fibres coated which cells with inhibit coagulation - for long-term use as implants in arteries and veins to carry sensors

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Publication number
DE3941873A1
DE3941873A1 DE19893941873 DE3941873A DE3941873A1 DE 3941873 A1 DE3941873 A1 DE 3941873A1 DE 19893941873 DE19893941873 DE 19893941873 DE 3941873 A DE3941873 A DE 3941873A DE 3941873 A1 DE3941873 A1 DE 3941873A1
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Patent type
Prior art keywords
cells
arteries
veins
hollow fibres
implants
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Withdrawn
Application number
DE19893941873
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German (de)
Inventor
Jakob Dr Bodziony
Original Assignee
Jakob Dr Bodziony
Priority date (The priority date 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 date listed.)
Filing date
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Classifications

    • 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
    • A61F2/0077Special surfaces of prostheses, e.g. for improving ingrowth
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L31/00Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/005Ingredients of undetermined constitution or reaction products thereof

Abstract

A semi-permeable material consisting of a hollow fibre is coated with a layer of firmly adhering cells which can control and stop coagulation processes by e.g. secreting certain factors, and which are pref. endo- and meso thelial cells, or cells which can change into such cells and which are immunologically tolerated like the cells of the host. USE/ADVANTAGE - The semi-permeable material can be used as an implant in arteries and veins for several years. The hollow fibres can be easily transported and implanted in the vascular system and can also be fitted with suitable sensors e.g. to monitor intravascular O2 or to regulate blood sugar levels in diabetics.

Description

Gattung des Anmeldungsgegenstandes Genre of the application object

Die Erfindung betrifft semipermeables Material, am häufigsten in der Form einer Hohlfaser gestaltet und beschichtet mit fest angehefteten Zellen, die die Gerinnungsprozesse durch ua Sekretion von bestimmten Faktoren kontrollieren und aufhalten können (vor allem Endo- und Mesothelialzellen aber auch Zellen die sich in solche umwandeln können) und immunologisch wie eigene Zellen toleriert sind, was mehrjährige Implantation in Arterien und Venen ermöglicht. The invention relates to semi-permeable material, shaped in the form of a hollow fiber most frequently and coated with firmly adherent cells that control coagulation processes by, inter alia, the secretion of certain factors and can stop (especially endo- and mesothelial cells but also cells that can be transformed into such ) and as our own cells are tolerated immunologically, allowing multi-year implantation in arteries and veins.

Angaben zur Gattung Information to the genus

Die vorgegebene beschichtete Hohlfaser soll vor allem als ein Teil oder die Hülle der in das Gefäßsystem implantablen Sensoren, Biosensoren und ion selektiven Elektroden benutzt werden. The predetermined coated hollow fiber to be used mainly as a part or the shell of the implant ablen in the vascular system of sensors, biosensors, and ion selective electrodes. Das kann die bisher nur zeitlich sehr begrenzt (1-2 Tage) realisierbare in-vivo Überwachung der lebenswichtigen metabolischen Faktoren wie pH, pO 2 , pCO 2 , Ca ++ , K⁺, Na⁺, Glukose, Harnstoff, Kreatinin usw. und deren automatische Korrektur in einem open-loop oder closed-loop System möglich machen. This can so far only very limited time (1-2 days) achievable in vivo monitoring of vital metabolic factors such as pH, pO2, pCO2, Ca ++, K +, Na +, glucose, urea, creatinine, etc. and make their automatic correction in an open-loop or closed-loop system possible. Die vorgegebene beschichtete Hohlfaser kann auch als mehrjährig-implantierte Infusionskanüle, als eine semipermeable Kammer für die ins Gefäßsystem implantierte Zellen und Geweben und als eine Diffusionskammer für bestimmte Arzneimittel benutzt werden. The predetermined coated hollow fiber can also serve as perennial-implanted infusion cannula, as a semi-permeable chamber used for the implanted into the vascular system of cells and tissues and as a diffusion chamber for certain drugs.

Stand der Technik State of the art

Bei bisherigen Versuchen zur Verhinderung der Aktivierung des Gerinnungs systems und der begleitenden Beschädigung der in das Gefäßsysstem implantier ten Sensoren (Armstrong und Mitarb., 1976; Goddard und Mitarb., 1974; Parce und Mitarb., 1989; Turner und Mitarb., 1987) hat man nur die Silikon- oder Teflonmembranen (Pfeiffer, 1987) und die Beschichtung von Sensoren mit hepa rinhaltigen Materialien (Hagihara und Mitarb., 1981) angewandt. Previous attempts to prevent the activation of the coagulation system and the accompanying damage to the Gefäßsysstem implantier th sensors (Armstrong et al, 1976;. Goddard et al, 1974;. Parce et al, 1989;. Turner et al., 1987) one has only the silicone or Teflon membranes (Pfeiffer, 1987), and the coating of sensors with hepa rinhaltigen materials (Hagihara et al., 1981) applied.

Kritik des Standes der Technik Criticism of the prior art

Die Hauptursache des Mißerfolgs der zur in-vivo Überwachung verwendeten und in Gefäßsystem implantierten Sensoren ist die Präzipitation der Erthrozyten, Thrombozyten, Leukozyten und des Fibrins auf der Sensoroberfläche. The main cause of failure of the sensors used for the in vivo monitoring and implanted in the vascular system is the precipitation of the Erthrozyten, platelets, leukocytes, and of fibrin on the sensor surface. Die Beschichtung des Sensors mit heparinhaltigen Materialien oder mit Silicon- und Teflonmembra nen verzögert nur die oben beschriebene Präzipitation aber es kann sie nicht verhindern (Pfeifer, 1987; Santiago und Mitarb., 1979; Hagihara und Mitarb., 1981). The coating of the sensor with heparin-containing materials or with silicone and Teflonmembra NEN only delays the precipitation described above but it can not prevent (Pfeifer, 1987; Santiago et al, 1979;. Hagihara et al., 1981). Im besten Fall muß der Sensor oder die Membran alle 24 Stunden gewechselt werden. At best, the sensor or membrane must be changed every 24 hours. Das macht die langzeitige Implantation von solchen Sensoren unmöglich und es ist ua eines der wesentlichsten Probleme bei der Konstruk tion des Systems zur automatischen Regulation des Blutzuckers bei diabetischen Patienten (Pfeiffer, 1987; Santiago und Mitarb., 1979). This makes the long-term implantation of such sensors impossible and it is inter alia one of the most essential problems, constructional tion of the system for automatic regulation of blood sugar in diabetic patients (Pfeiffer, 1987; Santiago et al., 1979).

Aufgabe task

Die Konstruktion der Hülle für implantable Sensoren und andere Materialien, die einerseits den Kontakt des Sensors mit dem Blutultrafiltrat, dessen bio chemische Zusammensetzung in bestimmten, sehr kleinen Zeitabständen die Zusam mensetzung des Blutes (ohne morphotische Elemente und bestimmte Proteine, die größer als die Permeablitätsgrenze sind) wiederspiegelt, andererseits die mehrjährige Implantation in Arterien und Venen ermöglicht. The construction of the case for implantable sensors and other materials, on the one hand the contact of the sensor with the Blutultrafiltrat whose bio chemical composition in particular, very small time intervals together mensetzung of the blood (without morphotische elements and certain proteins which are larger than the Permeablitätsgrenze ) reflects, on the other hand, the multi-year implantation in arteries and veins allows.

Lösung solution

Diese Aufgabe wird erfindungsmäßig dadurch gelöst, daß semipermeables Material mit entsprechend poröser und aktivierter Oberfläche mit fest angehefteten Zellen, die die Gerinnugsprozesse kontrollieren und aufhalten können und immunologisch wie eigene Zellen toleriert sind, beschichtet worden ist. This object is moderately achieved in that semi-permeable material has been coated with a correspondingly porous and activated surface with firmly adherent cells that can control the Gerinnugsprozesse and stopping and immunologically as own cells are tolerated.

Erzielbare Vorteile achievable benefits

Der Gegenstand der Erfindung ist gewerblich anwendbar durch die Herstellung von semipermeablen Materialien in Gestalt von z. The object of the invention is industrially applicable due to the production of semi-permeable materials in the form of z. B. Hohlfasern, die vor allem mit autogenen oder gewebetypisierten und gewebekulturproduzierten allogenen Endo- und Mesothelialzellen beschichtet sind. B. hollow fibers which are coated especially with autogenous or allogeneic gewebetypisierten and tissue culture-produced endo- and mesothelial cells. Diese Hohlfasern können einfach transportiert und in das Gefäßsystem implantiert werden. These hollow fibers can be easily transported and implanted in the vascular system. Die zellbeschichteten Hohlfasern können z. The cell-coated hollow fibers can eg. B. auch zusammen mit eingebauten Sensoren hergestellt und in implantationsfertiger Form transportiert werden. B. also produced together with built-in sensors and transported to implantation finished form.

Beschreibung des Ausführungsbeispiels Description of the embodiment

Abb. 1 und 2 zeigen das semipermeable Material in Gestalt einer Hohlfaser, mit eine Permeabilitätsgrenze von 50 kD, beschichtet in vitro mit autogenen Endothelialzellen, die aus der Jugularvene isoliert und durch Gewebekultur technik vermehrt worden sind. Fig. 1 and 2 show the semi-permeable material in the form of a hollow fiber, with a Permeabilitätsgrenze of 50 kD, coated in vitro with autogenous endothelial cells have been isolated from the jugular vein and propagated by tissue culture technology. Die Hohlfaser war danach in die untere Hohlvene der Ratte auf die Dauer von einem Jahr implantiert worden ( Abb. 1, 2). The hollow fiber was then implanted in the inferior vena cava of the rat for a period of one year (Fig. 1, 2). Es wurde in einer Reihe von ähnlichen Versuchen festgestellt, daß die vorgegebe nen beschichteten Hohlfasern keine Aktivierung des Gerinnungssystem induzier ten und auch nie immunologisch oder biologisch als Fremdkörper erkannt wurden. It was found in a series of similar experiments that the above-nen give coated hollow fibers were never immunologically or biologically detected any activation of the coagulation system inducer th and as a foreign body. Die biochemische Zusammensetzung des Blutultrafiltrats in inneren Teil der Hohlfaser spiegelt genau die biochemische Zusammensetzung des Blutes wieder (ohne Moleküle die großer als 50 kD sind). The biochemical composition of the Blutultrafiltrats in the inner part of the hollow fiber accurately reflects the biochemical composition of the blood again (without the molecules larger than 50 kD). Eine pH und pO 2 -Mikroelektrode, die im inneren Teil der Hohlfaser installiert und mit einem Meßsystem verbun den war, konnte sehr genau und langzeitig die pH oder pO 2 -Werte messen. A pH and pO2 -Mikroelektrode that was installed in the inner part of the hollow fiber and verbun with a measuring system to, could measure two values very accurate and long-term pH or pO.

Fundstellen sites

1. Armstrong RF, Hutchinson JM, Lincoln C., lngram D., Soutter L.: Conti nous mesurement of arterial oxygen tension during one-lung anaesthesia. 1. Armstrong RF, Hutchinson JM, C. Lincoln, lngram D., Soutter L .: Conti nous mesurement of arterial oxygen tension during one-lung anesthesia. Bri tish Journal of Anaesthesiology, 48, 1005-1010, 1976. Bri tish Journal of Anaesthesiology, 48, 1005-1010., 1976
2. Goddard P., Keith J., Marcovitch H., Roberton NRC, Rolfe P., Scopes JW: Use of a continously recording intravascular oxygen electrode in the newborn. 2. Goddard P., Keith J., Marcovitch H. Roberton NRC, Rolfe P., Scopes JW: Use of a continously recording intravascular oxygen electrode in the newborn. Archives of Disease in Childhood, 49, 853-860, 1974. Archives of Disease in Childhood, 49, 853-860., 1974
3. Hagihara B., Ishibashi F., Sato N., Minami T., Okada Y., Sugimoto T.: Intravascular oxygen monitoring with a polarographic oxygen cathode. 3. Hagihara example, Ishibashi F., Sato N., T. Minami, Y. Okada, Sugimoto T .: intravascular oxygen monitoring with a polarographic oxygen cathode. Journal of Biomedical Engineering, 3/1, 9-16, 1981. Journal of Biomedical Engineering, 3/1, 9-16., 1981
4. Parce WJ, Owicki JC, Kerco KM, Sigal GB, Wada HG, Muir VC, Bousse LJ, Ross KL, Sikic BJ, MCConnel HM: Detection of cell-affecting agents with a silicon biosensor. 4. Parce WJ, Owicki JC, Kerco KM, Sigal GB, HG Wada, Muir VC, Bousse LJ, Ross KL, Sikic BJ, McConnel HM: Detection of cell-Affecting agents with a silicon biosensor. Scince, 246, 243-247, 1989. Scince, 246, 243-247., 1989
5. Pfeiffer EF: On the way to the automated (blood) glucose regulation in diabetes: the dark past, the grey present and the rose future. 5. Pfeiffer EF: On the way to the automated (blood) glucose regulation in diabetes: the dark past, the gray present and the future rose. Diabetolo gia, 30, 51-65, 1987. Diabetolo gia, 30, 51-65., 1987
6. Santiago JV, Clemens AH, Clarke WL, Kipnis DM: Closed-loop and open-loop devices for blood glucose control in normal and diabetic subjects. 6. Santiago JV, Clemens AH, Clarke WL, Kipnis DM: Closed-loop and open-loop devices for blood glucose control in normal and diabetic subjects. Diabetes, 28/1, 71-84, 1979. Diabetes, 28/1, 71-84., 1979
7. Turner APF, Karube J., Wilson GS (eds.): Biosensors. 7. Turner APF, carob J., Wilson GS (eds.): Biosensor. Fundamentals and applications. Fundamentals and applications. Oxford Univ. Oxford Univ. Press, 1987, ISBN 0-19-854724-2. Press, 1987, ISBN 0-19-854724-2.

Claims (1)

  1. Semipermeables Material, am häufigsten in der Form einer Hohlfaser gestaltet, gekennzeichnet durch die Beschichtung mit fest angehafteten Zellen, die die Gerinnungsprozesse durch ua Sekretion von bestimmten Faktoren kontrollieren und aufhalten können (vor allem Endo- und Mesothelialzellen aber auch Zellen die sich in solche umwandeln können) und immunologisch wie eigene Zellen toleriert sind, was mehrjährige Implantation in Arterien und Venen ermöglicht. Semipermeable material, designed in the form of a hollow fiber most commonly characterized by the coating having a permanently attached cells that control coagulation processes by, inter alia, the secretion of certain factors and can stop (especially endo- and mesothelial cells but also cells that can be transformed into such ) and as our own cells are tolerated immunologically, allowing multi-year implantation in arteries and veins.
DE19893941873 1989-12-19 1989-12-19 Hollow fibres coated which cells with inhibit coagulation - for long-term use as implants in arteries and veins to carry sensors Withdrawn DE3941873A1 (en)

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Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE4123629A1 (en) * 1990-08-06 1992-02-20 Jakob Dr Bodziony Implantable semi-permeable bio-artificial organ - allowing biological signal and metabolic substance flow by pressure gradient
US5704910A (en) * 1995-06-05 1998-01-06 Nephros Therapeutics, Inc. Implantable device and use therefor
WO2002056796A1 (en) * 2000-12-01 2002-07-25 Nephros Therapeutics, Inc. Intravascular blood conditioning device and use thereof
FR2955179A1 (en) * 2010-01-13 2011-07-15 Univ Bordeaux 1 Sensor for measurement of insulin needs of a patient and method of manufacture thereof
US8048419B2 (en) 2006-02-02 2011-11-01 Innovative Biotherapies, Inc. Extracorporeal cell-based therapeutic device and delivery system
US9029144B2 (en) 2008-06-18 2015-05-12 Innovative Bio Therapies, Inc. Methods for enhanced propagation of cells

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WO1980002378A1 (en) * 1979-05-03 1980-11-13 Commw Scient Ind Res Org Device for promoting endothelial cell motility and/or vascularisation
DE3410631A1 (en) * 1983-03-23 1984-09-27 Univ Ramot Implant material to restore defective cartilage and bone
DE3432143A1 (en) * 1983-09-01 1985-03-21 Damon Biotech Inc A process for encapsulating a material to be enveloped
DE3422639C2 (en) * 1984-06-19 1986-07-10 Gebrueder Sulzer Ag, Winterthur, Ch
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EP0259536A2 (en) * 1986-09-11 1988-03-16 BAXTER INTERNATIONAL INC. (a Delaware corporation) Biological implant with textured surface
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EP0286284A1 (en) * 1987-03-30 1988-10-12 Brown University Research Foundation Semipermeable nerve guidance channels
EP0290642A1 (en) * 1987-05-12 1988-11-17 Mittermayer, Christian, Dr. med. Method for seeding polymeric surfaces with human endothelial cells
EP0296475A1 (en) * 1987-06-23 1988-12-28 Istituto Nazionale Per La Ricerca Sul Cancro Method for preserving transplantable sheets of epithelium cultured in vitro
EP0301777A1 (en) * 1987-07-28 1989-02-01 Queen's University At Kingston Multiple membrane microencapsulation
WO1989005345A1 (en) * 1987-12-11 1989-06-15 Whitehead Institute For Biomedical Research Genetic modification of endothelial cells
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WO1980002378A1 (en) * 1979-05-03 1980-11-13 Commw Scient Ind Res Org Device for promoting endothelial cell motility and/or vascularisation
DE3410631A1 (en) * 1983-03-23 1984-09-27 Univ Ramot Implant material to restore defective cartilage and bone
DE3432143A1 (en) * 1983-09-01 1985-03-21 Damon Biotech Inc A process for encapsulating a material to be enveloped
DE3422639C2 (en) * 1984-06-19 1986-07-10 Gebrueder Sulzer Ag, Winterthur, Ch
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EP0286284A1 (en) * 1987-03-30 1988-10-12 Brown University Research Foundation Semipermeable nerve guidance channels
EP0290642A1 (en) * 1987-05-12 1988-11-17 Mittermayer, Christian, Dr. med. Method for seeding polymeric surfaces with human endothelial cells
EP0296475A1 (en) * 1987-06-23 1988-12-28 Istituto Nazionale Per La Ricerca Sul Cancro Method for preserving transplantable sheets of epithelium cultured in vitro
EP0301777A1 (en) * 1987-07-28 1989-02-01 Queen's University At Kingston Multiple membrane microencapsulation
WO1989005345A1 (en) * 1987-12-11 1989-06-15 Whitehead Institute For Biomedical Research Genetic modification of endothelial cells
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EP0333328A2 (en) * 1988-02-17 1989-09-20 Genethics Limited Clinical developments using amniotic cells

Cited By (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE4123629A1 (en) * 1990-08-06 1992-02-20 Jakob Dr Bodziony Implantable semi-permeable bio-artificial organ - allowing biological signal and metabolic substance flow by pressure gradient
US5704910A (en) * 1995-06-05 1998-01-06 Nephros Therapeutics, Inc. Implantable device and use therefor
US5911704A (en) * 1995-06-05 1999-06-15 Nephros Therapeutics, Inc. Implantable device and uses therefor
US6572605B1 (en) 1995-06-05 2003-06-03 Nephros Therapeutics, Inc. Implantable device and use therefor
US6716208B2 (en) 1995-06-05 2004-04-06 Nephros Therapeutics, Inc. Implantable device and use therefor
WO2002056796A1 (en) * 2000-12-01 2002-07-25 Nephros Therapeutics, Inc. Intravascular blood conditioning device and use thereof
US8048419B2 (en) 2006-02-02 2011-11-01 Innovative Biotherapies, Inc. Extracorporeal cell-based therapeutic device and delivery system
US9029144B2 (en) 2008-06-18 2015-05-12 Innovative Bio Therapies, Inc. Methods for enhanced propagation of cells
FR2955179A1 (en) * 2010-01-13 2011-07-15 Univ Bordeaux 1 Sensor for measurement of insulin needs of a patient and method of manufacture thereof
WO2011086105A1 (en) * 2010-01-13 2011-07-21 Universite De Bordeaux 1 Sensor for measuring the activity of beta-pancreatic cells or of islets of langerhans, manufacture and use of such a sensor
US9962113B2 (en) 2010-01-13 2018-05-08 Universite De Bordeaux 1 Sensor for measuring the activity of beta-pancreatic cells or of islets of langerhans, manufacture and use of such a sensor

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