WO2000023124A9 - Multi-functional coatings for medical devices - Google Patents
Multi-functional coatings for medical devicesInfo
- Publication number
- WO2000023124A9 WO2000023124A9 PCT/US1999/024681 US9924681W WO0023124A9 WO 2000023124 A9 WO2000023124 A9 WO 2000023124A9 US 9924681 W US9924681 W US 9924681W WO 0023124 A9 WO0023124 A9 WO 0023124A9
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- layer
- functional coating
- mammal
- medical device
- device body
- Prior art date
Links
Classifications
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- 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
- A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
- A61L29/14—Materials characterised by their function or physical properties, e.g. lubricating compositions
- A61L29/16—Biologically active materials, e.g. therapeutic substances
-
- 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
- A61L27/54—Biologically active materials, e.g. therapeutic substances
-
- 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
- A61L31/00—Materials 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
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L31/16—Biologically active materials, e.g. therapeutic substances
-
- 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
- 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
-
- 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
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
- A61F2/06—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
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
- A61L2300/404—Biocides, antimicrobial agents, antiseptic agents
-
- 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
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
- A61L2300/42—Anti-thrombotic agents, anticoagulants, anti-platelet agents
-
- 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
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
- A61L2300/452—Lubricants
-
- 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
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/60—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a special physical form
- A61L2300/606—Coatings
- A61L2300/608—Coatings having two or more layers
- A61L2300/61—Coatings having two or more layers containing two or more active agents in different layers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0043—Catheters; Hollow probes characterised by structural features
- A61M25/0045—Catheters; Hollow probes characterised by structural features multi-layered, e.g. coated
Definitions
- the present invention relates generally to medical devices which require a specialized biocompatible surface coating because the devices are used inside of the body where they contact blood and other physiological fluids.
- Such devices include catheters, obturators, implants, artificial hearts, dialysis tubes and similar devices.
- the present invention relates to the coatings which are used to cover such devices to provide the device surface with ant microbial and antithrombogenic properties as well as other desirable properties.
- Synthetic materials have been used in many areas of medical treatment including artificial ocular lenses, heart valves, bypass tubes, implants, shunts, dialysis machines, catheters and other blood and fluid contacting devices or apparatus. Although the synthetic materials used to manufacture medical devices are mechanically stable and chemically inert, these synthetic materials are generally not biocompatible when exposed to bodily fluids such as blood.
- Biocompatibility involves a number of parameters related to how the medical device interacts with the host.
- Undesirable physiological reactions such as thrombosis, which is the formation of blood clots, or bacterial infection may result because the synthetic materials of which medical devices are manufactured cause proteins and other physiological fluid components to adhere to their surfaces providing a media for microbial colonization. The more prolonged the contact, the more likely infection and thrombosis will occur.
- Thrombosis is the body's natural mechanism to prevent uncontrollable bleeding whenever the lining of the vasculature is disturbed.
- the introduction of medical devices sometimes initiates this natural defense mechanism.
- the synthetic surface of many medical devices may exacerbate the thrombogenic response.
- a thrombus, or a portion of a thrombus may break free and travel throughout the vascular system, potentially causing serious problems downstream.
- Substantial research and development has been undertaken to control, if not eliminate, infection and thrombogenesis caused by medical devices.
- the vast majority of metals and synthetic polymers used to manufacture medical devices do not have antimicrobial or antithrombogenic capabilities of their own.
- thrombus formation is to treat the medical device surface with an anticoagulant substance such as heparin or with heparin reacted with a quaternary ammonium compound. Heparin interferes with the coagulation cascade, thereby inhibiting thrombus formation. See U.S. Pat. No. 5,069,899.
- Chlorhexidine alone or in combination with silver, has also been used as an antibiotic/antithrombogenic agent. See U.S. Pat. Nos. 5,165,952 and 5,019,096 which disclose exemplary antibiotic/antithrombogenic systems based on the use of chlorhexidine.
- Certain oligodynamic metals such as silver, are well known to have an antiseptic action, and have been mixed with dissimilar noble metal, such as platinum, and embedded in a polymer that is loaded with conductive material such as carbon black. When this polymer comes into contact with the electrolytic bodily fluids of a patient, a galvanic current flow is produced through the conductive material between the two metals, causing ions of the oligodynamic metal to be released into the body.
- the silver acts as a sacrificial electrode in the circuit giving off silver ions that are bacteriostatic and can stop growth of bacteria on the surface of the medical device. Medical devices incorporating this technology are shown and described in U.S. Pat. No.
- the multifunctional coatings in accordance with the present invention include both long-term and short-term antimicrobial properties, both long-term and short-term antithrombogenic properties, as well as coating which exhibit lubricious properties.
- the medical device includes a device body which has a surface that is located inside the mammal upon insertion or implantation.
- a multi-functional coating is provided which covers at least a portion of the surface of the device body.
- the multifunctional coating includes a first layer which is adjacent to the surface of the device body and a second layer which covers at least a portion of the first layer.
- the first and second layers each exhibit a different biological property when the device body is inserted or implanted within the mammal.
- multifunctional coatings are contemplated wherein the first layer exhibits antimicrobial properties and the second layer exhibits antithrombogenic properties.
- the multi-functional coating may include a third layer which covers at least a portion of the second layer.
- the third layer exhibits a biological property which is different from the biological properties exhibited by the underlying first and second layers.
- the third layer may be a lubricious coating.
- the multi-functional coatings may include up to five or more layers wherein each layer exhibits a different biological property.
- the various coatings can be tailored to exhibit long-term antimicrobial properties, short-term antimicrobial properties, long- term antithrombogenic properties, short-term antithrombogenic properties, as well as lubricious properties. It was found that layers which exhibit different biological properties may be applied to the device surface one on top of the other without inhibiting the biological activity of each layer. In situations where enhanced release of active ingredients from an underlying layer is required, the present invention provides silk screening or otherwise applying the outer coatings so as to enhance release of active ingredients.
- a multi-functional coating wherein silver sulfadiazine and chlorhexidine are combinded with a heparin complex in a single layer to provide both antimicrobial and antithrombogenic properties. These three ingredients may be combined in a single multi-functional layer without inhibiting the desired biological property of each ingredient.
- the multi-functional layer which includes silver sulfadiazine/chlorhexidine and a heparin complex may also be included as part of a multi-functional coating which includes additional layers such as an outer lubricious layer or layers providing short-term antimicrobial protection and/or short-term antithrombogenic protection.
- the multi-functional coatings are well suited for use as a coating to cover a wide variety of medical devices to provide short-term and long-term protection against infection and thrombus formation.
- the coating may include a lubricious layer to enhance the insertion or implantation procedure.
- FIG. 1 is a partial perspective view of an exemplary medical device having a multi-functional coating in accordance with the present invention.
- FIG. 2 is a sectional view of FIG. 1 taken in the 2-2 plane.
- FIG. 3 is a partial sectional view of a preferred exemplary medical device in accordance with the present invention wherein the multi-functional coating includes one layer.
- FIG. 4 is a partial sectional view of a preferred exemplary medical device in accordance with the present invention wherein the multi-functional coating includes two layers.
- FIG. 5 is a partial sectional view of the preferred exemplary medical device in accordance with the present invention wherein the multi-functional coating includes three layers.
- FIG.6 is a partial sectional view of the preferred exemplary medical device in accordance with the present invention wherein the multi-functional coating includes four layers.
- FIG. 7 is a partial sectional view of the preferred exemplary medical device in accordance with the present invention wherein the multi-functional coating includes five layers.
- FIG. 8 is a partial perspective view of a preferred exemplary medical device in accordance with the present invention wherein the second layer has been applied so that it does not completely cover the underlying first layer.
- FIGS. 1 and 2 A portion of a preferred exemplary medical device in accordance with the present invention is shown generally at 10 in FIGS. 1 and 2.
- the present invention is applicable to any medical device which is adapted or designed to be inserted or implanted within a mammal.
- the device 10 shown in FIGS. 1 and 2 is the end portion of a circular tube
- the present invention is applicable to all types of medical devices which are designed to be used inside the body on either a short-term or long-term basis.
- Such medical devices include catheters, obturators, backforms, sheaths, extracorporeal tubes, artificial heart valves, implants and shunts.
- such devices possess antimicrobial and antithrombogenic properties which reduce or eliminate microbial infections and thrombus (blood clot) which may result when the device is either inserted or implanted within the body.
- the devices may also be lubricious in order to reduce trauma during insertion into the body.
- the medical device 10 includes a device body 12 which is in the form of a circular tube.
- the device body 12 includes an outer surface 14 which is located inside the patient when the medical device is in use.
- a multifunctional coating 16 is provided which covers the surface 14.
- the coating 16 is in direct contact with physiologic fluids instead of the surface 14 when the device is located within the body.
- Exemplary materials which may be used to form the device body 12 include but not limited to biocompatible polymers such as polyvinylchloride, polyurethane, polyethylene terephthalate (PET), polytetrafluoroethylene (PTFE), polyethylene, silicone or other suitable conventionally used materials.
- Other suitable materials include biocompatible metal such as 3/16 stainless steel, platinum, gold, silver and alloys thereof. Additional materials include ceramics, glass and any of the other biocompatible (i.e., biologically inert) materials used to make implantable medical devices.
- FIG. 3 a portion of a first preferred exemplary medical device in accordance with the present invention is shown having a device body 12A and a multi-functional coating 16A.
- the multi-functional coating 16A includes a single layer which exhibits multiple biological properties when the medical device is inserted into or implanted within a mammalian body.
- the layer 16A exhibits both antithrombogenic and antimicrobial properties due to the incorporation of silver sulfadiazine, chlorhexidine and a heparin complex which may be, for example, stearylkonium heparin or benzalkonium heparin.
- the three ingredients may be combined in a suitable carrier material and applied to the device to form layer 16A which provides antimicrobial and antithrombogenic properties.
- the coating 16A is applied by dipping, spraying or otherwise applying a solution which contains a mixture of silver sulfadiazine, chlorhexidine and the heparin complex in an appropriate carrier.
- Suitable carriers include but not limited to alcohol-based solutions (i.e., isopropyl alcohol), tetrafluroethylene (class of flurohydrocarbons as replacement for chloro/fluro hydrocarbon (Freons)), tetrahydrofuran, hexane, and other known mixtures used to apply silver sulfadiazine, chlorhexidine and a heparin complexes as appropriate for the medical device body.
- the relative amounts of silver sulfadiazine, chlorhexidine and heparin complex may be varied to achieve desired levels of antithrombogenic and antimicrobial activity.
- percentage of any of the above-mentioned ingredients may be varied, for example, from 0.1% to 99.8%.
- the multi-functional coating 16B includes a first layer 18 and a second layer 20.
- the two layers 18 and 20 are coated onto the surface of the device body 12B. Both layers 18 and 20 exhibit different biological properties when the device body is inserted or implanted within a mammal.
- First layer 18 will preferably exhibit long-term anti-microbial properties.
- the layer 18 may include materials known to provide long-term antimicrobial properties such as silver, silver sulfadiazine, chlorhexidine, silver salts, and iontophoretic compositions. The above- mentioned materials may be deposited or incorporated in biodegradable polymer matrices such as polyglycolide and polylactide.
- the silver may be evaporated or sputtered onto the device body 12 in order to form layer 18.
- anti-microbial layers which include iontophoretic material (see PCT International Publication No. WO 97/38648) may be used. Additional materials which can be used to form the long-term antimicrobial layer may include but not limited to antibiotics and anionic, cationic or nonionic surfactants.
- the first layer 18 is preferably applied by dipping the device body 12B into a solution containing the active ingredients or by spraying the solution onto the device body. Exemplary solutions which may be utilized to coat the device body 12B in order to form first layer 18 include any suitable anti-microbial agents known in the art.
- the second layer 20 preferably will exhibit antithrombogenic properties when the medical device is located within the body.
- the second layer 20 is applied over layer 18.
- Suitable materials which may be used to provide long- term antithrombogenic protection include benzalkonium or stearylkonium heparin complexes, heparin salts in a water soluble matrix or biodegradable polymer, and other known antithrombogenic agents, which may include numerous anionic, cationic and nonionic surfactants.
- the exemplary solutions which can be applied over layer 18 to form layer 20 may include but not limited to those which contain antithrombogenic agents from a class of compounds, such as stearylkonium heparin complex
- heparin or the above-listed materials can be incorporated in a time-released biodegradable polymer matrix. If desired layers 18 and 20 can be reversed to provide a first layer with antithrombogenic properties and a second layer with antimicrobial properties.
- FIG. 5 A third exemplary embodiment of the present invention is shown in FIG. 5 at IOC.
- the medical device 10C includes a device body 12C which is covered by a three-layer, multi-functional coating 16C.
- the multi-functional coating 16C includes the same two preferred underlying layers 18 and 20 with an additional layer 22 being applied over layer 20.
- layer 18 provides long-term antimicrobial protection with layer 20 providing long-term antithrombogenic protection.
- long-term antimicrobial properties means that the coating is capable of exhibiting antimicrobial properties for at least 72 hours and "long-term antithrombogenic properties” means that the layer is capable of exhibiting antithrombogenic properties for at least 48 hours after insertion or implantation.
- the third layer 22 exhibits a biological property which is different from the underlying layers 18 and 20.
- the third layer 22 will be either a lubricious coating 22 or a coating which exhibits either short-term antimicrobial properties or short-term antithrombogenic properties. "Short-term” means less than 72 hours for antimicrobial properties and less than 48 hours for antithrombogenic properties.
- Suitable lubricious materials which may be used to form layer 22 include but not limited to hydrogels, silicones, surfactants, or other suitable materials known in the art. The lubricious material may be applied to form coating 22 utilizing any of the known conventional procedures for applying such materials to medical devices.
- layer 22 provide short-term antimicrobial or antibiotic properties
- silver salts or other suitable antibiotics be incorporated into a water soluble coating such as polysaccharides or collagens.
- a water soluble coating such as polysaccharides or collagens.
- Such coatings are designed to dissolve for periods of up to 72 hours to provide continual release of the antimicrobial/antibiotic agent from the surface. Once the coating 22 has dissolved, the underlying long-term protection provided by layers 18 and 20 remain in effect.
- Exemplary solutions which may be applied to the medical device 10C to form short-term antimicrobial or antibiotic layer include but not limited to water-soluble silver salts, antibiotics, surfactants.
- the layer 22 may also be formulated to provide short-term antithrombogenic protection.
- the layer 22 includes water soluble blood thinners and antiplatelet agents, such as aspirin and citrate.
- the coating is water-soluable so that the aspirin or citrate is released continually from the surface of the device for periods of up to 48 hours.
- Exemplary solutions which may be applied to the medical device IOC to form short-term antithrombogenic layer 22 are salicylic acid derivatives, citrates, and heparin salts.
- the device body 12D includes a multi-functional coating which has four layers.
- the first and second layers 18 and 20 are preferably the same long-term antimicrobial and antithrombogenic layers, respectively, that are shown in the previously described second and third embodiments (10B and IOC, respectively).
- the third layer 24 is preferably a short-term antimicrobial/antibiotic layer. This layer is the same as one of the optional layers 22 described in connection with the third embodiment IOC.
- the fourth layer 26 in this particular embodiment may be either a lubricious coating as previously described or a short-term antithrombogenic layer which also has been previously described.
- this particular embodiment is capable of providing four different biological functions which include long-term antimicrobial protection, long-term antithrombogenic protection, short-term antimicrobial protection, and short- term antithrombogenic protection.
- the short-term antithrombogenic protection layer may be replaced with a lubricious coating.
- a fifth exemplary embodiment of the present invention is shown at 10E in FIG. 7.
- a five-layer, multi-functional coating has been applied to the surface of the device body 12E.
- the first two layers 18 and 20 are the same as the previously described long-term protective layers discussed in the previous embodiments.
- the third layer 24 is also the same as the short-term antimicrobial layer described in connection with the embodiment shown in FIG. 6 (10D).
- the fourth layer 28 is a short-term antithrombogenic layer which has been previously described in connection with the other embodiments.
- the fifth layer is a lubricious coating which also has been previously described.
- the medical device 10F includes a device body 12F on which a multi-functional coating 16F has been applied.
- the first layer 18 is the same long-term antimicrobial ⁇ antibiotic layer which has already been described in connection with the previous embodiments.
- the second layer 32 is the same as previously described long-term antithrombogenic layer 20, except that the layer 32 has been silk-screened onto layer 18 to provide channels 34.
- the channels 34 provide direct access between physiologic fluids and layer 18 when the device 10F is implanted or inserted into the patient.
- a lubricious coating shown in phantom at 36 may be included.
- any other number of application procedures may be utilized provided that a well-defined and controllable pattern of material can be applied to form layer 32.
- the openings in the layer 32 are shown as channels 34 in FIG. 8, many other types of openings or voids through layer 32 are possible.
- the relative thickness of the multiple layers in the multi-functional coating may be varied widely with different layers having different thickness. In general, each layer will have a thickness ranging from a few angstroms up to half of millimeter or more with various thickness dictated by the nature of the coating material and the intended use.
- the concentrations of various active ingredients in each layer may also be varied to provide multi-functional coatings wherein one or more different biological properties are increased with respect to the biological properties provided by the other layers.
- the multi-functional coating may be applied to any of the conventional biocompatible materials which are used to form medical devices which are designed to be inserted or implanted within the body.
- the multi-functional coatings are combined in such a way that they do not interfere with each other's function or combined in such a way so as to enhance each other's individual effect or their combined effect.
- a summary of exemplary multi-functional coatings is set forth in the following Table. Other combinations are possible.
- the coatings are all applied using conventional solution or vapor deposition techniques.
Abstract
Description
Claims
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
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AU11296/00A AU1129600A (en) | 1998-10-22 | 1999-10-20 | Multi-functional coatings for medical devices |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
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US17741698A | 1998-10-22 | 1998-10-22 | |
US09/177,416 | 1998-10-22 |
Publications (2)
Publication Number | Publication Date |
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WO2000023124A1 WO2000023124A1 (en) | 2000-04-27 |
WO2000023124A9 true WO2000023124A9 (en) | 2000-08-24 |
Family
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Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
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PCT/US1999/024681 WO2000023124A1 (en) | 1998-10-22 | 1999-10-20 | Multi-functional coatings for medical devices |
Country Status (2)
Country | Link |
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AU (1) | AU1129600A (en) |
WO (1) | WO2000023124A1 (en) |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
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WO2022147363A1 (en) * | 2020-12-31 | 2022-07-07 | Cao Group, Inc | Long term antimicrobial additives utilizing alkaline earth salts of sulfonamide compounds |
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US6725083B1 (en) | 1999-02-02 | 2004-04-20 | Senorx, Inc. | Tissue site markers for in VIVO imaging |
US7983734B2 (en) | 2003-05-23 | 2011-07-19 | Senorx, Inc. | Fibrous marker and intracorporeal delivery thereof |
US9820824B2 (en) | 1999-02-02 | 2017-11-21 | Senorx, Inc. | Deployment of polysaccharide markers for treating a site within a patent |
US8361082B2 (en) | 1999-02-02 | 2013-01-29 | Senorx, Inc. | Marker delivery device with releasable plug |
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WO2022147363A1 (en) * | 2020-12-31 | 2022-07-07 | Cao Group, Inc | Long term antimicrobial additives utilizing alkaline earth salts of sulfonamide compounds |
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AU1129600A (en) | 2000-05-08 |
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