WO1998009667A1 - Instruments medicaux antimicrobiens et procedes de fabrication et d'utilisation - Google Patents
Instruments medicaux antimicrobiens et procedes de fabrication et d'utilisation Download PDFInfo
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- WO1998009667A1 WO1998009667A1 PCT/US1997/014186 US9714186W WO9809667A1 WO 1998009667 A1 WO1998009667 A1 WO 1998009667A1 US 9714186 W US9714186 W US 9714186W WO 9809667 A1 WO9809667 A1 WO 9809667A1
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- Prior art keywords
- implant
- xlo
- catheter
- catheters
- packaging
- Prior art date
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- 238000000034 method Methods 0.000 title claims description 46
- 230000000845 anti-microbial effect Effects 0.000 title claims description 7
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- 206010040047 Sepsis Diseases 0.000 claims description 3
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- MHWLWQUZZRMNGJ-UHFFFAOYSA-N nalidixic acid Chemical class C1=C(C)N=C2N(CC)C=C(C(O)=O)C(=O)C2=C1 MHWLWQUZZRMNGJ-UHFFFAOYSA-N 0.000 description 1
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- GGCZERPQGJTIQP-UHFFFAOYSA-N sodium;9,10-dioxoanthracene-2-sulfonic acid Chemical compound [Na+].C1=CC=C2C(=O)C3=CC(S(=O)(=O)O)=CC=C3C(=O)C2=C1 GGCZERPQGJTIQP-UHFFFAOYSA-N 0.000 description 1
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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
- A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
- A61L29/08—Materials for coatings
- A61L29/085—Macromolecular 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
- 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
- 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
Definitions
- the present method relates to the field of medical devices and more specifically relates to medical devices that resist microbial growth in situ.
- Infection is a frequent complication of many surgical, therapeutic, or diagnostic procedures. Although extreme precautions are taken to ensure the sterility of medical devices and implants prior to and during contact with a human or animal patient, contamination can occur.
- medical devices placed on or near a patient such as gloves, condoms, monitors, and other medical equipment may introduce infection through an incision, wound or burn.
- medical devices or implants placed within a patient for an extended period of time may provide a depot of bacteria, viruses, or fungi that, if allowed to grow unheeded, could causes serious illness or even death.
- the catheter has become the medical device of choice throughout the medical field for the removal or delivery of fluids, including pharmaceutical drugs, to patients.
- Catheters have been used over the past fifty years for intravenous, urological, cardiac care, wound drainage, and hydrocephalus treatment with great success.
- serious infections associated with catheter use such as septicemia and urinary tract infections, or cystitis, have become prevalent, particularly in patients who have had the devices left in situ for long periods of time.
- the treatment of catheter induced infection can be costly and difficult, especially in a patient that is immunocompromised or recovering from an extensive surgical procedure.
- medical personnel recommend that a catheter be replaced every forty-eight hours or less.
- this safety practice may be impractical in certain situations, such as in the use of central venous catheters.
- U.S. Patent No. 4,592,920 to Murtfeldt and U.S. Patent No. 5,320,908 to Sodervall et al. discuss the use of a thin layer of a metal, such as silver, on a catheter to reduce the incidence of infection.
- U.S Patent No. 4,259,103 to Malek et al. discloses a method of reducing infection by coating a catheter with an organic amine.
- U.S. Patent No. 4,563,485 to Fox, Jr. et al. teaches the incorporation of nalidixic acid derivatives into medical implants and devices to reduce infection.
- U.S. Patent No. 4,581,028 to Fox, Jr. et al. teaches the incorporation of metal salts of sulfonamides into medical implants and devices to reduce infection.
- U.S. Patent No. 4,612,337 to Fox, Jr. et al. teaches soaking a polymeric material with an antimicrobial agent, such as sodium sulfadiazine, and a metal salt of the antimicrobial agent to reduce infection.
- U.S. Patent No. 5,019,096 to Fox, Jr. et al. teaches the incorporation of a silver salt and chlorhexidine into medical implants and devices to reduce infection.
- medical personnel are generally concerned with the instability and leaching of such antibacterial agents and caution against the use of coated catheters. (T. S. J. Elliott, "Intravascular-device infections", J. Med. Microbiol. 27:161-167 (1988))
- a medical device or implant composed of a dielectric material, or coated with a dielectric substance, is subjected to electret treatment.
- the preferred electret treatment is electrostatic charging.
- the dielectric material or coating substance on the surface of the medical device or implant thereby attains a positive or negative charge.
- the device or implant is treated either prior to or after packaging.
- the device is packaged in a container or wrap that maintains sterility.
- the device or implant is sterilized either during formation, prior to treatment, or after treatment. Sterilization may be conducted either before or after packaging depending on the type of packaging utilized.
- the electret treated medical device or implant When allowed to come in contact with a patient or inserted or implanted into a patient, the electret treated medical device or implant resists microbial growth in situ, thereby providing a device that can remain in contact with, implanted, or inserted for a longer period of time with a higher degree of safety than currently available devices, particularly catheters.
- the present invention provides a simple, rapid, and inexpensive method for producing medical devices and implants, such as catheters, that resist microbial growth in situ.
- the present invention also provides antimicrobial devices that can remain inserted in a patient for greater than forty-eight hours without promoting infection at the insertion site or in the tissues or fluids in contact with the device.
- the present invention also provides a method for inhibiting infection in catheterized patients by utilizing a catheter that has been subjected to electret treatment.
- Medical devices or implants resistant to microbial growth and methods of production and use are provided.
- a medical device or implant composed of a dielectric material, or coated with a dielectric substance is subjected to electret treatment.
- the electret treated medical device or implant is resistant to microbial growth, particularly microbial growth in situ.
- Medical devices embodying the present invention include all types of medical devices that contact patients or are important in health care, such as, but not limited to, table tops, hospital beds, monitors, and various specific medical devices, as long as the devices are capable of being subjected to electret treatment.
- a medical device that cannot be conveniently treated, due to its size, shape or material composition, may include a removable surface that is more easily treated. Medical devices are those for use both externally and internally.
- Suitable medical devices and implants include, for example, urinary catheters, both internal and external; intravenous catheters; and cardiac catheters, including those useful for balloon angioplasty; contraceptives such as condoms; medical gloves, such as surgical and examination gloves; wound dressings; drainage tubes; orthopedic, penile and other implants; wound clips; sutures; hernia patches; arterial grafts; respiratory therapy devices, such as ventilator or trachea tubes; and heart valves.
- the medical devices or implants or the surfaces of medical devices or implants can be made of a variety of natural or synthetic materials such as plastics and polymers, and include Dacron ® , rubber, latex, silicone, polyurethane, polyvinyl chloride, Teflon ® , polypropylene, polyethylene, polyolefins, poly(lactic acid), and polyglycolic acid.
- the preferred electret treatment method is electrostatic charging.
- the dielectric material or coating substance on the surface of the device or implant thereby attains a positive or negative charge.
- the surface need not retain the charge throughout the use of the device or implant, but should be charged when the device or implant comes in contact with or is implanted or inserted into the patient, referred to herein as in situ.
- the device or implant is charged either prior to or after packaging.
- the device or implant is packaged in a container or wrap that maintains sterility.
- the device or implant is sterilized either during formation, prior to treatment, or after treatment. Sterilization may be conducted either before or after packaging depending on the type of packaging utilized.
- the term "medical device" as used herein includes medical implants.
- the medical device most particularly suited for electret treatment in accordance with the preferred method of production and use described herein is the catheter.
- the electret treated medical device or implant When placed in contact with a patient or implanted or inserted into a patient, the electret treated medical device or implant resists microbial growth in situ, thereby providing a device that can remain in contact with, implanted or inserted for a longer period of time with a higher degree of safety than currently available devices.
- An electret treated catheter for the delivery of a fluid or gas is particularly useful because the time interval between replacements can be extended.
- the surfaces of medical devices or implants treated in accordance with the present method resist the growth of a wide variety of microorganisms including, but not limited to, bacteria, viruses, yeasts and fungi.
- the treated devices or implants are useful in situations where it is desirable to inhibit the in situ growth of bacteria including, but not limited to, E. coli, staphylococci (most particularly coagulase-negative staphylococci and S. aureus) streptococci, diphtheroids, Propionibacterium, Enterobacter, Serratia, Enterococcus, Proteus, Yersinia, and other gram-negative bacilli including Klebsiella and Pseudomonas.
- the treated devices or implants are useful for inhibiting the in situ growth of yeasts such as Candida.
- the medical devices described herein are particularly useful for reducing the incidence of infection in a patient in whom a catheter must be inserted. Such catheters are most particularly useful for reducing infection in a patient in whom a catheter must remain in place for forty-eight hours or more.
- the electret- treated catheters described herein are particularly useful for inhibiting or reducing bacterial infections such as septicemia, bacteriuria, urinary tract infections and cystitis when inserted into a patient requiring catheterization.
- catheters include, but are not limited to, the following general categories of catheters: cardiac, urethral, vascular, renal, neurological, respiratory, gynecological and wound drainage catheters.
- catheters specifically further include, but are not limited to, urological, intravenous, and intracardiac catheters; and catheters used for balloon angioplasty, middle ear drainage, hemorrhage control, hydrocephalus treatment, irrigation, ventilation, removal of prostatic obstruction, dilation, calibration, and sample collection from areas of the body such as the lung or renal pelvis.
- the preferred catheter is composed of a natural or synthetic material capable of retaining a charge after subjection to an electric charge, commonly referred to by those skilled in the art as a dielectric material.
- the catheter is coated with a dielectric material.
- dielectric is defined herein as a material, such as a polymer, which is an electrical insulator or in which an electric field can be sustained with a minimum dissipation of power.
- a solid material is a dielectric if its valence band is full and is separated from the conduction band by at least 3 eV. This definition is adopted from the
- Suitable dielectric materials include, but are not limited to, a variety of plastics and polymers such as silicone, TeflonTM, DacronTM, latex, rubber, polyester, nylon, polyurethane, polyvinyl chloride, polypropylene, polyethylene, poly(lactic acid), polyglycolic acid, and polyolefins in general, and derivatives thereof. Charging Techniques
- Any type of charging methodology and equipment capable of charging a dielectric material is suitable for treating medical devices or implants to inhibit microbial growth in accordance with the present method.
- Electrostatic charging is preferred.
- the resulting charge on the surface of the dielectric material may be either positive or negative.
- Methods of subjecting a material to charging, for example electrostatic charging are well known by those skilled in the art. These methods include, for example, thermal, liquid-contact, electron beam and corona discharge methods.
- corona discharge is achieved by the application of sufficient direct current (DC) voltage to an electric field initiating structure (EFIS) in the proximity of an electric field receiving structure (EFRS).
- the voltage should be sufficiently high such that ions are generated at the EFIS and flow from the EFIS to the EFRS.
- Both the EFIS and the EFRS are preferably formed from conductive materials. Suitable conductive materials include conductive metals such as copper, tungsten, stainless steel and aluminum.
- a preferred charging technique is described in U.S. Patent No. 5,401,446, assigned to the University of Tennessee, which is incorporated by reference herein. This technique involves subjecting a material to a pair of electrical fields having opposite polarities. Each electrical field forms a corona discharge.
- a more preferred charging technique is the electret technique described in U.S. Patent No. 5,370,830 to Cohen and Jameson, which is incorporated by reference herein. Briefly, the electret technique of Cohen and Jameson involves passing a dielectric material through a corona discharge treatment assembly consisting of a positive and negative electrode, one above and one below the dielectric material. Each electrode is powered by a power supply. The material is passed through the corona discharge at a convenient speed. The corona discharge treatment assembly applies positive volts to one surface of the material and negative volts to the other surface of the material.
- an electret techmque in which the spacing between the electrodes is sufficient and the voltage is adjusted to prevent arcing due to the inherent flammability of many packaging materials and the possibility of creating holes in the packaging materials.
- the preferred spacing between electrodes for a conventional catheter is approximately between 1 and 2 inches (or 2.5 cm and 5 cm).
- the spacing between the material being subjected to electret treatment and the electrodes must be adjusted to accommodate the size and shape of the item.
- the medical device or implant may be packaged either before or after being subjected to electret treatment or charging and may be sterilized either before or after electret treatment.
- the medical device or implant is packaged prior to treatment.
- the size of the packaging and composition of the packaging material may influence the type of charging apparatus and method that can be successfully utilized.
- Suitable packaging materials include, for example, polymeric materials such as polyethylene and spun fibers of polyethylene (such as TyvecTM).
- the device or implant is packaged with a layer of opaque packaging material affixed by an adhesive or heat seal to a layer of transparent material so that the device or implant can be identified both visually and by a printed description.
- the device or implant has an additional internal wrapping, preferably composed of a transparent polymer material similar to that described above.
- the packaging material should be sterilizable and have the ability to maintain sterility during the storage, transport and handling of the medical device or implant.
- the packaging material must allow the charge or charges to pass through to the device or implant and must be capable of withstanding the charging technique without deterioration. Sterilization
- Suitable sterilization methods include, but are not limited to, steam sterilization, plasma sterilization, ethylene oxide sterilization, gamma radiation sterilization, and ozone sterilization.
- the device or implant may be subjected to charging followed by sterilization or subjected to sterilization followed by charging.
- the device or implant may be sterilized before or after packaging, provided that, in the latter case, the sterilization method is capable of penetrating the packaging material.
- the device or implant may be formed and packaged under sterile conditions.
- Example 1 Effect of Electret Treatment on E. coli Growth on Catheters: Qualitative Observations
- ArgyleTM TeflonTM-coated latex FoleyTM catheters in their packaging were electret treated to impart a charge of approximately 1,000 volts.
- One additional catheter provided the untreated control.
- Two of the treated catheters were charged with approximately 1,000 negative volts and two with approximately 1,000 positive volts.
- the catheters were cut into approximately 5 cm sections and incubated for 24 hours in a solution of protein containing E. coli (final concentration 10 9 /ml). These sections were washed three times in a solution of protein. The sections were then rolled on TripticaseTM Soy Agar plates. (Carr Scarborough Microbiological Labs. Inc., Atlanta, GA) The plates were incubated for a sufficient amount of time to allow normal bacterial growth. The development of E. coli growth on the plates was observed.
- Charging was conducted with a charge on the negative electrode of -12 Kv to -10 Kv and a charge of +12 Kv to +10 v on the positive electrode.
- the operating temperature was approximately 68°F to 72°F and the relative humidity from approximately 30% to 60%.
- the throughput speed was from approximately 10 to 20 feet per minute. This electret process caused each catheter to be negatively charged (approximately 1500 volts). Data from previous experiments had demonstrated that similar catheters held this charge for more than six months.
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Abstract
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
AU40631/97A AU4063197A (en) | 1996-09-04 | 1997-08-11 | Antimicrobial medical devices and methods of production and use |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US70746596A | 1996-09-04 | 1996-09-04 | |
US08/707,465 | 1996-09-04 |
Publications (1)
Publication Number | Publication Date |
---|---|
WO1998009667A1 true WO1998009667A1 (fr) | 1998-03-12 |
Family
ID=24841810
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/US1997/014186 WO1998009667A1 (fr) | 1996-09-04 | 1997-08-11 | Instruments medicaux antimicrobiens et procedes de fabrication et d'utilisation |
Country Status (3)
Country | Link |
---|---|
AU (1) | AU4063197A (fr) |
WO (1) | WO1998009667A1 (fr) |
ZA (1) | ZA977606B (fr) |
Cited By (11)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO1998058681A3 (fr) * | 1997-06-20 | 1999-03-18 | Ep Technologies | Enduits pour catheters et dispositifs a fins diagnostiques et therapeutiques par contact direct |
WO2002045564A3 (fr) * | 2000-12-05 | 2003-04-24 | Johnson & Son Inc S C | Systeme triboelectrique |
US7087661B1 (en) | 1998-09-23 | 2006-08-08 | Cernofina, Llc | Safe and effective biofilm inhibitory compounds and health-related uses thereof |
US7513093B2 (en) | 2002-10-04 | 2009-04-07 | Ethicon, Inc. | Method of preparing a packaged antimicrobial medical device |
US8960422B2 (en) | 2002-10-04 | 2015-02-24 | Ethicon, Inc. | Packaged antimicrobial medical device and method of preparing same |
US20150202064A1 (en) * | 2011-09-06 | 2015-07-23 | Cook Medical Technologies Llc | Electrically charged medical device |
US9474524B2 (en) | 2002-10-04 | 2016-10-25 | Ethicon, Inc. | Packaged antimicrobial medical device having improved shelf life and method of preparing same |
WO2017053451A1 (fr) * | 2015-09-21 | 2017-03-30 | Board Of Regents, The University Of Texas System | Dispositif de système de drainage en boucle continue et procédé d'utilisation |
US9763814B2 (en) | 2014-10-24 | 2017-09-19 | Cook Medical Technologies Llc | Elongate medical device |
US10245025B2 (en) | 2012-04-06 | 2019-04-02 | Ethicon, Inc. | Packaged antimicrobial medical device having improved shelf life and method of preparing same |
TWI838783B (zh) * | 2022-07-04 | 2024-04-11 | 財團法人國家實驗研究院 | 微生物抑制裝置 |
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1997
- 1997-08-11 AU AU40631/97A patent/AU4063197A/en not_active Abandoned
- 1997-08-11 WO PCT/US1997/014186 patent/WO1998009667A1/fr active Application Filing
- 1997-08-25 ZA ZA9707606A patent/ZA977606B/xx unknown
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US4142521A (en) * | 1976-12-23 | 1979-03-06 | Hoffmann-La Roche Inc. | Electrostatic soft tissue wound repair enhancement |
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JPS6242715A (ja) * | 1985-08-14 | 1987-02-24 | Toyobo Co Ltd | 抗菌性を有するエレクトレツトフイルタ−用複合材料 |
EP0346058A1 (fr) * | 1988-06-07 | 1989-12-13 | Btg International Limited | Appareils médicaux |
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JPH07204263A (ja) * | 1994-01-13 | 1995-08-08 | Atsushi Shimada | 抗血栓性医療マテリアル及び人工血管・人工肺・人工透析膜・人工透析回路・血管内カテーテル |
WO1995019796A1 (fr) * | 1994-01-21 | 1995-07-27 | Brown University Research Foundation | Implants biocompatibles |
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PATENT ABSTRACTS OF JAPAN vol. 95, no. 11 26 December 1995 (1995-12-26) * |
Cited By (19)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US5991650A (en) * | 1993-10-15 | 1999-11-23 | Ep Technologies, Inc. | Surface coatings for catheters, direct contacting diagnostic and therapeutic devices |
US6357447B1 (en) | 1993-10-15 | 2002-03-19 | Ep Technologies, Inc. | Surface coatings for catheters, direct contacting diagnostic and therapeutic devices |
WO1998058681A3 (fr) * | 1997-06-20 | 1999-03-18 | Ep Technologies | Enduits pour catheters et dispositifs a fins diagnostiques et therapeutiques par contact direct |
US7087661B1 (en) | 1998-09-23 | 2006-08-08 | Cernofina, Llc | Safe and effective biofilm inhibitory compounds and health-related uses thereof |
WO2002045564A3 (fr) * | 2000-12-05 | 2003-04-24 | Johnson & Son Inc S C | Systeme triboelectrique |
AU2002220137B2 (en) * | 2000-12-05 | 2006-06-29 | S.C. Johnson & Son, Inc. | Triboelectric cleaning system |
US9597072B2 (en) | 2002-10-04 | 2017-03-21 | Ethicon, Inc. | Method of preparing a packaged antimicrobial medical device |
US8960422B2 (en) | 2002-10-04 | 2015-02-24 | Ethicon, Inc. | Packaged antimicrobial medical device and method of preparing same |
US9149273B2 (en) | 2002-10-04 | 2015-10-06 | Ethicon, Inc. | Packaged antimicrobial medical device |
US9474524B2 (en) | 2002-10-04 | 2016-10-25 | Ethicon, Inc. | Packaged antimicrobial medical device having improved shelf life and method of preparing same |
US7513093B2 (en) | 2002-10-04 | 2009-04-07 | Ethicon, Inc. | Method of preparing a packaged antimicrobial medical device |
US9597067B2 (en) | 2002-10-04 | 2017-03-21 | Ethicon, Inc. | Packaged antimicrobial medical device and method of preparing same |
US20150202064A1 (en) * | 2011-09-06 | 2015-07-23 | Cook Medical Technologies Llc | Electrically charged medical device |
US9381102B2 (en) * | 2011-09-06 | 2016-07-05 | Cook Medical Technologies Llc | Electrically charged medical device |
US10245025B2 (en) | 2012-04-06 | 2019-04-02 | Ethicon, Inc. | Packaged antimicrobial medical device having improved shelf life and method of preparing same |
US11707272B2 (en) | 2012-04-06 | 2023-07-25 | Cilag Gmbh International | Packaged antimicrobial medical device having improved shelf life and method of preparing same |
US9763814B2 (en) | 2014-10-24 | 2017-09-19 | Cook Medical Technologies Llc | Elongate medical device |
WO2017053451A1 (fr) * | 2015-09-21 | 2017-03-30 | Board Of Regents, The University Of Texas System | Dispositif de système de drainage en boucle continue et procédé d'utilisation |
TWI838783B (zh) * | 2022-07-04 | 2024-04-11 | 財團法人國家實驗研究院 | 微生物抑制裝置 |
Also Published As
Publication number | Publication date |
---|---|
ZA977606B (en) | 1998-02-23 |
AU4063197A (en) | 1998-03-26 |
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