WO1994011058A1 - Iontophoretic structure for medical devices - Google Patents
Iontophoretic structure for medical devices Download PDFInfo
- Publication number
- WO1994011058A1 WO1994011058A1 PCT/US1993/010911 US9310911W WO9411058A1 WO 1994011058 A1 WO1994011058 A1 WO 1994011058A1 US 9310911 W US9310911 W US 9310911W WO 9411058 A1 WO9411058 A1 WO 9411058A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- galvanic
- iontophoretic
- metal particles
- catheter
- conductive polymer
- Prior art date
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/20—Applying electric currents by contact electrodes continuous direct currents
- A61N1/30—Apparatus for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body, or cataphoresis
- A61N1/303—Constructional details
- A61N1/306—Arrangements where at least part of the apparatus is introduced into the body
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/20—Applying electric currents by contact electrodes continuous direct currents
- A61N1/30—Apparatus for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body, or cataphoresis
- A61N1/303—Constructional details
Definitions
- the invention relates to oligodynamic iontophoresis, an more particularly to an electrically conductive structure fo medical devices that reduces or eliminates bacteria infection by killing bacteria with controlled oligodynami iontophoresis.
- Oligodynamic metals such as silver, are effective i minute quantities as bacteriostats and bactericides. Th most active form of these oligodynamic metals is as ions i solution. While the precise nature of the bactericida effect is unknown, it is believed to involve altering th function of the cell membrane or linking to the cell's DN to disrupt cell function. The bactericidal action i effective against a broad spectrum of bacteria, including al of the common strains which cause infection. When thes metals are used in the minute concentrations required to kil or stem the growth of bacteria, they do not have an detrimental effect on normal mammalian cells.
- Silver is used routinely in antibacterial salves, suc as silver sulfadiazine, and has also been used in clinica trials to coat gauze for burn dressings.
- Medical devices such as catheters, with silver impregnated in a solubl collagen or polymer coating are also known. After thes catheters are placed, the coating slowly dissolves and th silver is released over time into the environment. Th infection rates with these products are reported to be tw to four times lower than standard catheters.
- Iontophoresis describes the movement of ions in a conductiv fluid under the influence of low-strength electric fields and in this context refers to the forcing of ions into conductive fluid environment using minute electric currents
- a metal such as silver
- a conductive medium such as a saline, blood or urine
- an electrical potential i applied across the electrodes silver ions are driven int solution creating an enhanced bactericidal effect.
- Th current required to safely drive a sufficient amount o silver ions into solution to control infection is in th range of 1 to 400 microAmperes. This current range does no cause localized cell necrosis and it is below the sensory o pain threshold.
- German Patent Documen DE 3,830,359 two dissimilar metal powders not in electrica contact with each other are embedded in a nonconductiv catheter material, such as electrically insulating polymers Because of the separation of dissimilar metals by a insulator, it is not likely that there is any iontophoresi effect in this device as a result of a potential bein created by the dissimilar metals, except for the possibilit of when a biofil forms on the catheter surface to complet the circuit. Were an electrical circuit to be formed in thi manner, the current density would not be regulated o predictable, and the current produced therefore could b either too high to be safe or too low to be effective.
- An oligodynamic iontophoresis catheter which uses th properties of metals to generate a current and to form an io barrier for killing bacteria at a localized body entry i disclosed in U.S. Patent No. 4,569,673 to Tesi.
- Tesi teache placing a strip of an oligodynamic metal on a nonconductiv substrate.
- the oligodynamic metal acts as a sacrificia galvanic anode and gives off ions when placed in conductiv contact with a dissimilar metal by placing the catheter i an electrolytic solution.
- the Tesi device only provides localize infection control. Thus, none of these devices fulfill the promise held ou by oligodynamic iontophoresis for reducing infection in long term indwelling medical devices.
- the present invention provides an iontophoreti structure for a medical device that reduces the risk o infection associated with prolonged medical devic implantation in the body.
- the invention i directed toward meeting performance goals of genera antibacterial effectiveness; minimal electrode corrosion precise control of electrical current; portability of th current source; and ease of manufacture. These performanc requirements can be readily addressed by a number o embodiments in which a controlled electrical current drive oligodynamic metal ions into solution to kill bacteria on an near the iontophoretic structure.
- an iontophoretic structure for medical device includes a first and second galvanic materia separated by a resistive material, which when placed i contact with an electrolytic solution creates a current flo which injects anti-bacterial oligodynamic metal ions into th solution.
- an elastomer incorporates a firs and a second galvanic material separated by resistiv material which controls a current flow between the galvani materials when the elastomer is immersed in an electrolyti fluid.
- the first and second galvanic materials can be meta powders in a conductive polymer that forms a composit material which may be dip-coated over an existing cathete or extruded to form the catheter itself.
- th galvanic materials can be configured in layered structures, wherein each metal layer is separated from the other by resistive layer. The layered structures can be placed o surfaces of the catheter where antibacterial action i desired.
- two dissimilar metal powder embedded in a conductive polymer substrate create a infection control sleeve that covers an ordinary catheter.
- an electrolytic fluid t complete a circuit between the metal powders, metal ions ar driven into solution where they have an antibacterial effect.
- This embodiment is also useful as a catheter introduce sheath.
- a method fo giving an implantable medical device antibacterial propertie by placing an iontophoretic structure on its surface prio to implantation.
- the iontophoretic structure can be eithe a coating including two dissimilar metal powders in conductive polymer substrate, or a layered structure havin two dissimilar metal layers separated by a conductive layer
- a method fo protecting a natural body structure with an iontophoreti structure comprising two dissimilar metal powders in conductive base material.
- the iontophoretic structure i painted onto the body structure when the base material is i a softened or uncured state.
- the base material is the allowed to harden or cure.
- Fig. 1 is a perspective view of an iontophoresi catheter incorporating a composite material comprising meta powders in a conductive elastomeric matrix;
- Fig. 2 is a partial sectional view of the iontophoresi catheter of Fig. 1;
- Fig. 3 is a depiction of the iontophoresis effec created by the composite material in the catheter of Fig. 1
- Fig. 4 is a perspective view of a pacing lead coate with the composite material of Fig. 1;
- Fig. 5 is a perspective view of an artificial hip join partially coated with the composite material of Fig. 1;
- Fig. 6A is a perspective view of an infusion pump coate with the composite material of Fig. 1;
- Fig. 6B is a perspective view of a tooth coated with th composite material of Fig. 1;
- Fig. 7 is a perspective view of a catheter with a iontophoresis infection control sheath;
- Fig. 8 is a perspective view of a catheter with a iontophoresis infection control introducer sheath
- Fig. 9 is a perspective view of an iontophoresi catheter having a plurality of layered electrodes
- Fig. 10 is a perspective view of an und embodiment of an iontophoresis catheter having a pluralit of layered electrodes arranged in strips;
- Fig. 11 is a partial sectional view of the iontophoresi catheter of Fig. 10.
- Iontophoretic structures in accordance with th invention may be divided into two categories: a composit material used to coat a medical device, or a plurality o discrete layered electrodes placed on the medical device, both of which categories are disclosed hereinbelow.
- Th medical device can be a short-term, long-term, or permanen implant and includes such devices as: urinary catheters, vascular access catheters and introducer sheaths, flui introduction tubing and fittings such as intra-venous tubing, urinary drainage bags and tubing, chest drainage tubes, infusion pumps, pacing leads, tracheotomy tubes, ventilatio tubes, prosthetic joints, heart valves, wound dressings, orthopedic pins or plates, or any other medical device use in an environment or application where anti-bacteria properties are a consideration.
- urinary catheters are an especially attractive application for th iontophoretic structures, the ensuing detailed descriptio is directed thereto.
- Fig. 1 illustrates a exemplary iontophoresis catheter 10 that uses the composit material approach to kill bacteria.
- the iontophoresi catheter 10 is substantially identical to a normal or non infection controlling catheter in that it is a hollo flexible tube comprising an elastomeric wall 12 having a inner surface 14 and an outer surface 16, a proximal end 18 and a distal end 20.
- the generally cylindrical inner surfac 14 defines a lumen 22 for the passage of fluid.
- Both th proximal end 18 and the distal end 20 are provided with on or more openings 26 to allow the fluid to be introduced or evacuated from the lumen 22.
- the distal end 20 is shaped to facilitate insertion or placement of the iontophoresis catheter 10 into the body.
- the iontophoresis catheter 10 may also be fitted with a retention device 28, such as a balloon fitting, to prevent unintentional withdrawal of the iontophoresis catheter 10 from the body.
- Fig. 2 is a partial sectional view of the iontophoresis catheter 10 of Fig. 1, taken along the line A-A' , that depicts details of a composite material comprising galvanic materials, such as metal powders, in a conductive elastomeric matrix 30 that distinguishes the iontophoresis catheter 10 from prior art catheters.
- the wall 12 of the catheter comprises the conductive base material 30, and a first and a second dissimilar metal powder, 32 and 34 respectively.
- the base material 30 is a conductive polymer similar to that used in static-proof bags for packaging charge-sensitive electronics in which the conductivity (resistivity) is controlled to a predetermined value by its composition.
- Exemplary conductive polymers can be made from polymers including polyvinyl, polyester, polyethylene, or a naturally conductive polyvinylidene fluoride. When loaded with carbon or other conductive fillers, for example, these polymers can be made conductive and thereby used as the base material 30 for an iontophoresis catheter 10.
- Exemplary first and second metal powder combinations having an electrochemical half-cell potential difference include silver and gold, silver and copper, or silver and platinum mixed into the polymer at very low volume concentrations prior to extrusion fabrication of the composite catheter 10. Although these exemplary powders are relatively expensive, they are used in such minute quantities that their use does not adversely impact overall cost of the iontophoresis catheter 10.
- the elastomeric wall 12 is extruded, it is feasible to make the entire wall 12 from the composite material 30, 32, 34.
- Foley catheters which are typically made of latex and/or silicone rubber are not extruded, but are generally dip-cast, and finish-coating in a final dip is a natural processing step in their manufacture. Therefore, the iontophoresis catheter 10 can be made by finish-coating it with the composite material 30, 32, 34. Since rubber is generally inferior to plastic in terms of infection rates, overcoating with a castable plastic is advantageous in and of itself.
- each powdered metal granule embedded in the base material 30 that makes contact with the electrolytic fluid 24 becomes either an anode or a cathode, depending on the particular metals chosen as the first and second metal powders 32, 34.
- a depiction of the iontophoresis effect created by the composite material 30, 32, 34 in the catheter of Fig. 2 is shown.
- the first and second metal powders 32, 34 act as electrodes and create a voltag potential therebetween, whereby electrons 36 migrate throug the base material 30 and generate an electric current.
- Meta ions 38 are thus driven into the conductive fluid 24 b iontophoresis.
- the electric current is regulated by th quantity and nature of metal powder 32, 34 embedded in th base material 30 and by the conductivity of the base material 30.
- r is the average metal powder granule radius (cm)
- V is the voltage produced by the two dissimilar metal powders 32, 34 in the electrolytic fluid
- L is the metal powder volume loading of the bas material as a fraction (ie 0-1) .
- the metal powders ar assumed to be of the same granule size and of the same volum loading. In practice, they do not have to be the same siz and volume loading.
- a current density between 10 ' to 10' 6 Amperes per mm 2 , which is the desired range to b bacteriostatic or bactericidal and yet not be so high as t cause pH changes or other deleterious mammalian cel reactions, the following exemplary values can be used in th above equation to define the composite materia specifications:
- An iontophoresis catheter 10 incorporating the abov described composite material has numerous advantages over th prior art with respect to effectiveness, controllability, an ease of use. Foremost, bacterial potency is maximize because metal is guaranteed to go into solution as ions, thu producing a minimum ten-fold reduction in bacteria colonization rate. Also, the iontophoresis catheter 10 doe not need an external current source or controller because th iontophoresis current is self-generating and self-regulating
- the metal powders 32, 34 are dispersed through the base material 30, and because th current level is very low, the electrodes are functional fo months of use. There is also no place in the circuit wher corrosion of the electrodes at the air/electrolyte interfac - 14 -
- Fig. 10 depicts an alternative configuration of th iontophoresis catheter 70, wherein the plurality of layere structures 72 are bands that surround the wall 12 Alternatively, the layered structures 72 can be a pluralit of longitudinal strips.
- the embodiments of Figs. 9 and 1 permit selective placement of a layered structure 72 on a isolated region of the wall 12, or distribution of th layered structures 72 on the entire wall 12.
- Each layered electrode 72 comprises a first metal electrod 76, a resistive layer 78, and a second metal electrode 80
- the metal are biocompatible and form an electrical potential differenc between them in an electrolytic fluid.
- the conductiv (resistive) base material 30 regulates the current flo between the first and second metals 32, 34, in thi embodiment the (conductive) resistive layer 78 regulates th current flow between the dissimilar metals of the first an second electrodes 76, 80.
- a current density of 10" 8 Amperes per mm 2 results if th thickness of the resistive layer 78 is approximately 1 micrometers and has a bulk conductivity of 10 11 Ohm-cm and th exposed area of each of the electrodes 76, 80 in the layere structures 72 is the same.
- Typical combinations of metal used for the first and second metal electrodes 76, 8 generate between 0.1 to 2 Volts. Therefore, the thicknes of the above described resistive layer 78 can be between and 20 micrometers.
- Fig. 4 is a illustration of the composite material 30, 32, 34 used t protect a pacing lead 40.
- the pacing lead 40 connects th heart tissue to the control and monitoring apparatus of cardiac pacemaker (not shown) via a wire 42 and an electrod 44 in the tissue.
- the wire 42 is shown covered with th composite material 30, 32, 34.
- Fig. 5 is a depiction of th composite material 30, 32, 34 used with a prosthetic device such as an artificial hip joint 46.
- the shaft 48 is show coated with composite material 30, 32, 34 and implanted int a femur 50.
- Fig. 6A shows an infusion pump 52 coated wit the composite material 30, 32, 34 and connected to tubing 5 which may also be coated.
- the composite material 30, 32, 34 can also be coate onto a natural body structure 55, such as a tooth, a illustrated in Fig. 6B. This is accomplished by painting th composite material 30, 32, 34 onto the surface to b protected while the base material 30 is in a liquified o softened state and then letting the base material 30 harden
- the base material 30 is binar adhesive, such as a catalytic, two-part, conductive epox mix.
- a vascular access add on device that benefits from the composite material approac for an iontophoretic structure is shown in Fig. 7, wherei an ordinary catheter 56 is shown fitted with an infectio control kit 58 incorporating the composite material 30, 32 34.
- the infection control kit 58 is an after-market devic - 12 - which includes a replaceable iontophoretic infection control sleeve 60 and an iontophoretic Luer adaptor 62 for connecting the proximal end 18 of the catheter 56 to intravenous (I.V.) tubing 64.
- the sleeve 60 made of or coated with the composite material 30, 32, 34 slips over the outer surface 16 of the catheter 56 to be inserted the body.
- the sleeve 60 covers only a short section of the catheter 56 near its proximal end 18, but is long enough to enter the body wherein moisture will activate the iontophoresis process.
- the sleev 60 thus protects the catheter surface 16 from infection.
- the Luer adaptor 62 may also be made of or coated on the inner surface with the composite material 30, 32, 34 to protect the inner surface 14 of the catheter 56 from bacterial colonization progressing down to the catheter 56 from the inside of the I.V. tube 64.
- the sleeve 60 is fabricated fro one of the above referenced conductive base materials 30; and the Luer adaptor 62 is made of a harder plastic, such as acrylic or polycarbonate.
- the sleeve 60 may be configured to accommodate a variety of catheter sizes.
- An adaptation of the composite material sleeve 60 ca also be configured as a catheter introducer sheath 66, show in Fig. 8, for inserting pulmonary artery (Swan-Ganz o thermodilution) catheters, temporary pacing leads, etc., which may remain in place for several weeks. Under norma circumstances, an introducer sheath is left in place with th catheter which it surrounds for a portion of its length, including the region where the device penetrates the skin.
- pulmonary artery Swan-Ganz o thermodilution
- Iontophoretic introducer sheaths 66 are easily manufacture with the composite material approach because they ar predominantly made of polytetrafluorethylene (Teflon®) , viny (PVC) , or polyethylene (PE) , materials which can be loade with carbon or other conductive fillers or made conductiv by other means known in the art and then loaded as well a the first and second metal powders 32, 34.
- Fig. 8 shows the introducer sheath 66 used i conjunction with a thermodilution catheter 68. Balloon an - 13 - temperature sensing elements, 74 and 75 respectively, know to those skilled in the art, are shown on the distal end 20.
- the composite material 30, 32, 34 of the introducer sheat 66 protects both the sheath 66 and the outer wall 12 of th thermodilution catheter 68.
- the introducer sheath 66 is virtuall identical in size, shape, and use as prior art devices.
- the integral power source for driving oligodynamic metal ions int solution is the electromotive force created by dissimila metal powders 32, 34 embedded in and separated from eac other by the conductive base material 30 of specificall created resistivity.
- Figs. 9-11 a variety of embodiment of the other category of iontophoretic structure for medical device are shown which incorporate the plurality o discrete layered structures.
- plurality of layered structures comprise dissimilar galvani materials separated by a resistive layer.
- a perspective view of an embodimen of an iontophoresis catheter 70 is shown, wherein th oligodynamic iontophoresis effect is achieved using plurality of layered structures 72 on either the inne surface 14, the outer surface 16, or both of a non-conductiv wall 12.
- the layered structures 72 while depicted in circular configuration can be any shape, such as oval o square. and thickness for the resistive layer 78 are possible t obtain the target current density.
- An iontophoresis catheter comprising: an elastomeric cylindrical wall having an outer wall surface and an inner wall surface, said inner wall surface defining a lumen for containing an electrolytic fluid, and a distal end and a proximal end, each said end having at least one opening to permit introduction or evacuation of said electrolytic fluid from said lumen, said elastomeric cylindrical wall comprising a plurality of layered electrodes comprising a first metal layer, a second metal layer, and a resistive layer therebetween, said resistive layer having a predetermined resistance for controlling an electric current produced between said first metal layer and said second metal layer when said iontophoresis catheter is immersed in said electrolytic fluid to produce a desired current density that has an antibacterial effect.
- An iontophoresis infection control kit for a catheter having a distal end, a proximal end, an inner lumen, and an outer surface comprising: an infection control sleeve comprising a first metal powder and a second metal powder embedded in a conductive elastomeric material having a predetermined resistance for controlling a current flow produced between said first metal powder and said second metal powder when said infection control sleeve is in contact with an electrolytic solution to produce a desired current density that has an antibacterial effect, said sleeve placed over said outer surface of said catheter near said proximal end.
Abstract
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Priority Applications (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CA002149216A CA2149216C (en) | 1992-11-12 | 1993-11-10 | Iontophoretic structure for medical devices |
EP94901417A EP0678047A4 (en) | 1992-11-12 | 1993-11-10 | Iontophoretic structure for medical devices. |
JP51235594A JP3555684B2 (en) | 1992-11-12 | 1993-11-10 | Electrophoretic structures for medical devices |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
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US07/975,597 US5322520A (en) | 1992-11-12 | 1992-11-12 | Iontophoretic structure for medical devices |
US975,597 | 1992-11-12 |
Publications (1)
Publication Number | Publication Date |
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WO1994011058A1 true WO1994011058A1 (en) | 1994-05-26 |
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Application Number | Title | Priority Date | Filing Date |
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PCT/US1993/010911 WO1994011058A1 (en) | 1992-11-12 | 1993-11-10 | Iontophoretic structure for medical devices |
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US (3) | US5322520A (en) |
EP (1) | EP0678047A4 (en) |
JP (1) | JP3555684B2 (en) |
CA (1) | CA2149216C (en) |
WO (1) | WO1994011058A1 (en) |
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US9457125B2 (en) | 2007-09-17 | 2016-10-04 | Synergy Biosurgical Ag | Medical implant with electromagnetic radiation responsive polymer and related methods |
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Also Published As
Publication number | Publication date |
---|---|
JPH08506027A (en) | 1996-07-02 |
EP0678047A4 (en) | 1996-03-27 |
JP3555684B2 (en) | 2004-08-18 |
CA2149216C (en) | 2000-10-17 |
EP0678047A1 (en) | 1995-10-25 |
US5498248A (en) | 1996-03-12 |
US5725817A (en) | 1998-03-10 |
CA2149216A1 (en) | 1994-05-26 |
US5322520A (en) | 1994-06-21 |
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