[go: up one dir, main page]

WO1998002197A1 - Revetement thromboresistant de polymere acrylique - Google Patents

Revetement thromboresistant de polymere acrylique Download PDF

Info

Publication number
WO1998002197A1
WO1998002197A1 PCT/GB1997/001886 GB9701886W WO9802197A1 WO 1998002197 A1 WO1998002197 A1 WO 1998002197A1 GB 9701886 W GB9701886 W GB 9701886W WO 9802197 A1 WO9802197 A1 WO 9802197A1
Authority
WO
WIPO (PCT)
Prior art keywords
composition
parts
emulsion
acrylic
acrylic polymer
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.)
Ceased
Application number
PCT/GB1997/001886
Other languages
English (en)
Inventor
Robin Peter Cooper
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Individual
Original Assignee
Individual
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
Publication date
Application filed by Individual filed Critical Individual
Priority to GB9900635A priority Critical patent/GB2330361B/en
Priority to AU36268/97A priority patent/AU3626897A/en
Publication of WO1998002197A1 publication Critical patent/WO1998002197A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • 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
    • A61L33/00—Antithrombogenic treatment of surgical articles, e.g. sutures, catheters, prostheses, or of articles for the manipulation or conditioning of blood; Materials for such treatment
    • A61L33/0005—Use of materials characterised by their function or physical properties
    • A61L33/0011—Anticoagulant, e.g. heparin, platelet aggregation inhibitor, fibrinolytic agent, other than enzymes, attached to the substrate
    • A61L33/0029—Anticoagulant, e.g. heparin, platelet aggregation inhibitor, fibrinolytic agent, other than enzymes, attached to the substrate using an intermediate layer of polymer
    • 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
    • A61L33/00—Antithrombogenic treatment of surgical articles, e.g. sutures, catheters, prostheses, or of articles for the manipulation or conditioning of blood; Materials for such treatment
    • A61L33/0005—Use of materials characterised by their function or physical properties
    • A61L33/0011—Anticoagulant, e.g. heparin, platelet aggregation inhibitor, fibrinolytic agent, other than enzymes, attached to the substrate
    • 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
    • A61L33/00—Antithrombogenic treatment of surgical articles, e.g. sutures, catheters, prostheses, or of articles for the manipulation or conditioning of blood; Materials for such treatment
    • A61L33/06—Use of macromolecular materials
    • A61L33/064—Use of macromolecular materials obtained by reactions only involving carbon-to-carbon unsaturated bonds

Definitions

  • the present invention relates to a method of coating a surface to render it thromboresistant.
  • Thromboresistance is important for medical devices exposed to blood flow for an extended length of time. Failure to render the surface of such a device thromboresistant can result in formation of a thrombosis, which can lodge in a life threatening position in a patient.
  • a number of factors can increase the thromboresistance of a surface, but no one single factor appears to ensure complete thromboresistance.
  • Anti-coagulants are well known and can be deposited on a surface to improve its thromboresistance.
  • a method of raising the thromboresistance of a surface of a medical device by depositing on it a non-toxic acrylic polymer composition.
  • a non-toxic acrylic polymer composition for r sing the thromboresistance of a surface on which it is deposited.
  • the composition is deposited by flowing the composition in a water based emulsion of it over the surface.
  • the flowing can be achieved by pumping the emulsion through it.
  • the medical device is of complex shape, since it enables interstices which the blood can readily reach in use of the device to be treated.
  • the medical device can be dipped into the emulsion. The process can be completed by blowing warm air through or over the device. This removes the water .and any residual low molecule weight volatiles, from the emulsion, leaving the acrylic polymer composition deposited on the surface.
  • the acrylic polymer is provided as a copolymer.
  • better thromboresistance can be provided by incorporation of a water soluble anti-coagul.ant into the emulsion.
  • the anti-coagulant is deposited with the acrylic polymer. It acts to discourage initiation of coagulation on the surface.
  • the anti-coagatet can be heparin or heparin derivatives, trisodium citrate, citric acid or hirudin or hirudin derivatives.
  • a hydrophobic material can be incorporated in the emulsion.
  • an emulsifiable wax can be used. It is deposited with the acrylic polymer and by its surface energy discourages any deposit from blood on the surface having the composition on it. Where both anti-coagulant and hydrophobic materials are incorporated, it is believed that the latter slows leaching of the former from the composition.
  • Figure 1 is a diagrammatic view of a blood heat exchanger being treated in a first step in depositing an acrylic copolymer composition in accordance with the invention
  • Figure 2 is a similar view of a second step in the treatment of the heat exchanger; and Figure 3 is a similar view of other medical devices being treated in accordance with the invention.
  • Figure 1 shows a pump 4 connected by pipes 5, 6 to the inlet 2 .and outlet 3 of the heat exchanger via a vat 7 of emulsified thromboresistant composition described below.
  • the composition is pumped through it, allowing the emulsified components of the composition to deposit over the entire internal wetted surface of the heat exchanger.
  • the pump After a suitable length of time for the composition to build up, typically 20 minutes, the pump is stopped and the pipes 5, 6 removed. After the remaining liquid has drained from it, the exchanger has a drying air duct 11 connected to the inlet 2 and a blower 12 blows air through the exchanger until the composition has dried, see
  • FIG. 1 A moisture trap 13 and an exhaust extraction fan 14 are fitted to the outlet of the heat exchanger. After drying, the inlet and outlet are sealed until the device is used.
  • the heat exchanger is made of a variety of dissimilar materials.
  • the composition of the emulsified thromboresistant composition is as follows (in parts by weight):
  • Acrylic copolymer emulsion typically Texicryl TD 6213 100 parts
  • Anti-coagulant typically trisodium citrate 0-30 parts
  • Figure 3 shows an alternative method of treatment, useful for elongate devices 21, such as stents and catheters. These are suspended from hooks 22 above a vat 23 of emulsified thromboresistant composition. The hooks are ganged together and can be lowered towards the vat, for immersion of the devices in the composition. They are successively lowered and raised until the composition has built on the surface of the devices to a sufficient extent. Where it is critical that all surfaces are completely covered including the point of connection to the hooks - as in a stent as opposed to a catheter or wound drain having a . n end left outside the body - the devices can be upended halfway through the treatment process. As with the heat exchanger, the final step in the treatment is the drying of the composition deposited on the devices. Stents are usually of stainless steel and can be treated with the same composition as the heat exchanger.
  • Wound drainage catheters are usually of polyvinylchloride PVC, polyurethane PU, or silicone material. The latter two materials are known to be more thromboresistant. Tests have shown the thromboresistance of PNC catheters can be improved to the level of those of PU catheters by treatment with a similar composition to that used for the heat exchanger, without the wax emulsion.
  • the hydrogel coating can be an aqueous solution of poly(hydroxy ethyl methacrylate) (HEMA), polyvinylalcohol (PVOH), poiy( ⁇ -vinyl-2-pyrrolidone) inte ⁇ olymer (PVP) or poly(ethylene oxide) (PEO) as well as suitable hydrocolloids.
  • HEMA poly(hydroxy ethyl methacrylate)
  • PVOH polyvinylalcohol
  • PVP poiy( ⁇ -vinyl-2-pyrrolidone) inte ⁇ olymer
  • PEO poly(ethylene oxide)
  • Texicryl TD 6213 (a Scott Bader trade name) is a styrene-acrylate copolymer emulsion. It is anticipated that other acrylic compositions will be effective, in particular copolymers based on: (meth)acrylic esters styrene and acrylic acid esters styrene and (meth)acrylic esters.
  • Texicryl TD 6213 other suitable polymers include Revacryl 100, 123, 143, 612, all products of Harlow Chemical Co. Ltd., Harlow, England.
  • Texicryl TD 6213 is a copolymer emulsion, formed by emulsion polymerisation.
  • the copolymer has a styrene butyl acrylate backbone, with a glass transition temperature of -12°C.
  • styrene-2-ethyl hexyl acrylate can be used.
  • the emulsion stabilising system utilises an alkali soluble copolymer with carboxylic acid functionality. This is used to achieve high resistance to water attack. Ammonia is used to solubilise the copolymer which, on drying, leaves an insoluble ammonium salt.
  • the carboxylic acid functionality gives good compatibility (and potentially chemical bonding) with the styrene butyl acrylate, the main polymer, rendering the whole system resistant to re-emulsification.
  • acrylic polymers are suitable. In particular they should be non-toxic. For devices having a long life in use they should be resistant to attack by body fluids.
  • the wax emulsion is preferably based on either beeswax or paraffin to avoid toxicological problems.
  • the composition of a preferred paraffin wax emulsion is as follows (in parts by weight): Paraffin Wax BP
  • composition of a preferred beeswax emulsion is as follows (in parts by weight):
  • Advantages of the invention can include: i) No unusual cleaning of the medical devices (beyond that dictated by their medical use) prior to treatment in accordance with the invention is thought to be necessary; ii) The compositions and coating processes involved are low cost; iii) Use of devices treated with the coating is anticipated to result in improvements in patient safety, care and recovery rates; iv) Use of an aqueous emulsion avoids the use of solvents which are expensive and/or awkward to dispose of and avoids involvement in VOC regulations.

Landscapes

  • Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Materials Engineering (AREA)
  • Engineering & Computer Science (AREA)
  • Hematology (AREA)
  • Surgery (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Materials For Medical Uses (AREA)
  • Paints Or Removers (AREA)

Abstract

La présente invention concerne une composition polymère acrylique permettant d'augmenter la thromborésistance d'une surface sur laquelle elle est déposée et comprenant les ingrédients suivants (en parties en poids): émulsion de copolymère acrylique poids sec 100 parties, anticoagulant 0-60, émulsion de cire poids sec 0-30 parties, eau 100-700 parties.
PCT/GB1997/001886 1996-07-13 1997-07-11 Revetement thromboresistant de polymere acrylique Ceased WO1998002197A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
GB9900635A GB2330361B (en) 1996-07-13 1997-07-11 Thromboresistant coating made of acrylic polymer
AU36268/97A AU3626897A (en) 1996-07-13 1997-07-11 Thromboresistant coating made of acrylic polymer

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GB9614784.8 1996-07-13
GBGB9614784.8A GB9614784D0 (en) 1996-07-13 1996-07-13 Thromboresistant coating

Publications (1)

Publication Number Publication Date
WO1998002197A1 true WO1998002197A1 (fr) 1998-01-22

Family

ID=10796895

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/GB1997/001886 Ceased WO1998002197A1 (fr) 1996-07-13 1997-07-11 Revetement thromboresistant de polymere acrylique

Country Status (3)

Country Link
AU (1) AU3626897A (fr)
GB (2) GB9614784D0 (fr)
WO (1) WO1998002197A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0982041A1 (fr) * 1998-08-21 2000-03-01 Medtronic Ave, Inc. Revêtement tromborésistant à base de silanes ou de siloxanes

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0003389A1 (fr) * 1978-01-19 1979-08-08 The British Petroleum Company p.l.c. Procédé de revêtement de surfaces sous-marines avec de la cire et compositions de revêtement ainsi appliquées
EP0323341A2 (fr) * 1987-12-25 1989-07-05 TERUMO KABUSHIKI KAISHA trading as TERUMO CORPORATION Instrument médical
WO1989007520A1 (fr) * 1988-02-19 1989-08-24 Bristol-Myers Company Procede d'enduction de surfaces polymeres et produits enduits realises au moyen dudit procede
EP0484057A2 (fr) * 1990-11-02 1992-05-06 The Dow Chemical Company Surfaces antithrombogènes, leur préparation et matériau pour leur préparation
DE4334272A1 (de) * 1993-10-07 1995-04-13 Stemberger Axel Dr Beschichtung für Biomaterial

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0003389A1 (fr) * 1978-01-19 1979-08-08 The British Petroleum Company p.l.c. Procédé de revêtement de surfaces sous-marines avec de la cire et compositions de revêtement ainsi appliquées
EP0323341A2 (fr) * 1987-12-25 1989-07-05 TERUMO KABUSHIKI KAISHA trading as TERUMO CORPORATION Instrument médical
WO1989007520A1 (fr) * 1988-02-19 1989-08-24 Bristol-Myers Company Procede d'enduction de surfaces polymeres et produits enduits realises au moyen dudit procede
EP0484057A2 (fr) * 1990-11-02 1992-05-06 The Dow Chemical Company Surfaces antithrombogènes, leur préparation et matériau pour leur préparation
DE4334272A1 (de) * 1993-10-07 1995-04-13 Stemberger Axel Dr Beschichtung für Biomaterial

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0982041A1 (fr) * 1998-08-21 2000-03-01 Medtronic Ave, Inc. Revêtement tromborésistant à base de silanes ou de siloxanes
US6248127B1 (en) 1998-08-21 2001-06-19 Medtronic Ave, Inc. Thromboresistant coated medical device
US6361819B1 (en) 1998-08-21 2002-03-26 Medtronic Ave, Inc. Thromboresistant coating method
US6830583B2 (en) 1998-08-21 2004-12-14 Medtronic Ave, Inc. Thromboresistant coating composition
USRE39438E1 (en) * 1998-08-21 2006-12-19 Medtronic Vascular, Inc. Thromboresistant coated medical device

Also Published As

Publication number Publication date
AU3626897A (en) 1998-02-09
GB2330361A (en) 1999-04-21
GB9614784D0 (en) 1996-09-04
GB2330361B (en) 1999-09-15

Similar Documents

Publication Publication Date Title
JP6495241B2 (ja) 医療用具の製造方法および医療用具
US6258371B1 (en) Method for making biocompatible medical article
JP4976632B2 (ja) 生物学的適合性を有する医療用物質およびその製造方法
JP4185226B2 (ja) 湿潤時に表面が潤滑性を発現する医療用具およびその製造方法
WO2001039811A1 (fr) Fil metallique, tube ou catheter comprenant un revetement hydrophile
JPH02277458A (ja) 改良された親水性滑性被膜
WO2016084716A1 (fr) Instrument médical et son procédé de fabrication
JP6600560B2 (ja) 抗血栓性コーティング材の製造方法
JPH02503889A (ja) ポリマー表面のコーティング方法およびその方法を用いてコーティングした製品
JP5969484B2 (ja) 抗血栓性材料および医療用具
JP3522839B2 (ja) 湿潤時に表面が潤滑性を有する医療用具及びその製造方法
WO1998002197A1 (fr) Revetement thromboresistant de polymere acrylique
Mardis Evaluation of Polymeric Materials for Endourologic Devices-Emerging Importance of Hydrogels
JP2022508521A (ja) 医療機器
US20230119743A1 (en) Hydrophilic Medical Catheters
JP4626005B2 (ja) 血液適合性組成物およびそれを被覆した医療用具
EP2100627B1 (fr) Copolymère de (méth)acrylate, procédé de production de celui-ci et dispositif médical
JPH0819599A (ja) 湿潤時に表面が潤滑性を有する医療用具及びその製造方法
JPH02144070A (ja) 易滑性医療材料
WO2024181302A1 (fr) Procédé de production d'un dispositif médical
JPS6397158A (ja) 人工血管
JP6812191B2 (ja) 高分子化合物、抗血栓性高分子材料、およびそれを用いた医療機器
JPS61168365A (ja) 抗血栓性医療用材料
WO2014123077A1 (fr) Matériau de revêtement médical et dispositif médical
JPS62258670A (ja) 人工血管及びその製造方法

Legal Events

Date Code Title Description
AK Designated states

Kind code of ref document: A1

Designated state(s): AU CA GB JP US

AL Designated countries for regional patents

Kind code of ref document: A1

Designated state(s): AT BE CH DE DK ES FI FR GB GR IE IT LU MC NL PT SE

DFPE Request for preliminary examination filed prior to expiration of 19th month from priority date (pct application filed before 20040101)
121 Ep: the epo has been informed by wipo that ep was designated in this application
NENP Non-entry into the national phase

Ref country code: JP

Ref document number: 1998505737

Format of ref document f/p: F

122 Ep: pct application non-entry in european phase
NENP Non-entry into the national phase

Ref country code: CA