Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Utility Patent
1999-03-26
2001-01-02
Dawson, Glenn K. (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S020000, C604S021000
Utility Patent
active
06168580
ABSTRACT:
FIELD OF INVENTION
This invention is related to antimicrobial devices, processes and materials for catheters which are used to provide access to blood and other physiologic vessels and, especially, for such processes in which catheters are left in situ over long periods of time and are therefore likely subject to becoming a pathway for infection.
DESCRIPTION OF RELATED ART
Problems associated with medical devices which come into contact with infection-sensitive areas of the body and become introducers of infection are well known in contemporary medicine. In particular, indwelling catheters are known to be dangerous conduits by which infection is introduced over time. The longer the time indwelling catheters are in place, the greater the likelihood of resulting serious infection. Invasive medical devices such as central venous catheters (CVCs), peripherally inserted catheters (PICCs), endotracheal catheters and urinary catheters are known sources of infection as a result of microbial colonization.
Even though a large number of infections are the result of a small number of organisms, (e.g.
Staphylococcus epidermidis, Staphylococcus aureus
and
Candida albicans
), the number is neither limited nor well defined. It is now well known in the medical art that organisms may and can change to make contemporary chemical antimicrobial agents less effective and even ineffective as time passes.
Antimicrobial creams or coatings, such as chlorhexidine, may not only be becoming ineffective, but may themselves be contaminated before application. Still more of a dilemma is the growing tendency to lengthen the period of use of long-term indwelling catheters. For this reason, even more effective products which use heavy metals (e.g. gold, silver and copper) to provide antimicrobial activity, are not effective for a long enough period of time when indwelling catheters are used for extended periods. Shortcomings of known current approaches, whether it be by chemical or by elution of heavy metals, generally do not provide protection of sufficiently extended periods to provide complete protection for all uses of extended use indwelling catheters, an example of which is found in the use of central venous catheters (CVCs).
In addition, catheter technology in general and CVC technology specifically has matured to the point where many different catheter types and sizes are available to fulfill many general and special medical procedure needs. An attempt to compete with any established catheter manufacturer, much less with the total set of manufacturers as a body would likely be unsuccessful by a neophyte catheter manufacturer.
BRIEF SUMMARY AND OBJECTS OF THE INVENTION
In brief summary, this novel invention alleviates serious problems related to microbial infections resulting from implantation of catheters used to provide access to blood and other physiologic vessels, especially of those catheters which are implanted for a long period, e.g. three months or longer. The instant invention includes apparatus and methods for applying an attachable integral jacket and sleeve subassembly about an indwelling catheter at an insertion site for the purpose of reducing and preventing microbial infections associated with catheterization procedures.
In one embodiment, the invention is effectively applied to techniques and apparatus disclosed in U.S. Pat. Nos. 5,409,467, issued to Raad et al., Apr. 25, 1995 and 5,324,275 issued to Raad et al., Jun. 28, 1994 (generally referenced herein by Raad). In this case, the invention provides opportunity for electrically exciting a pair of electrodes, disposed parallel to one another and powered by a power source and electronics which are an inherent part of the jacket. So disposed and powered, the electrodes elute ions which are displaced from one electrode to the other to provide an effective antimicrobial zone of influence.
Such is substantially different from teachings disclosed in Raad. Raad discloses affixing a helical electrode and electrode connections directly to a catheter. While such is possible and practical for a given catheter manufacturer to affix electrodes and connections as a part of a manufacturing process, it may be impractical to so affix the electrodes to a catheter subsequent to catheter manufacture by another vendor, and especially impractical to apply electrodes and connections after catheter sterilization.
As an example, one contemporary intravascular catheter manufacturer makes and markets as many as seventy different catheter types and models. It would be highly unlikely that a start-up catheter manufacturer could enter the catheter market and effectively compete with a reasonably few number of catheter types and/or models. It may be even less likely that a company which is proficient in manufacture of devices made in accordance with the instant invention also be effective in making catheters. For this reason, an important feature of the invention is the ability to affix elements of the invention to a catheter as an added feature preparatory to use.
Various embodiments of the invention are possible, including impregnating an entry or percutaneous sleeve of the device with antimicrobial substances. Generally, the device consists of two separate parts, although it may be made from one or more parts. The first part includes a catheter jacket and sleeve subassembly from which the antimicrobial agent is eluted. The jacket and sleeve are formed to fit firmly about an indwelling catheter in such a manner that the catheter attachment may be engaged by snapped or threaded containment. In this manner, an unmodified catheter (standard catheter), regardless of catheter variety, vendor or application may be used with the invention. In any case, the sleeve provides access to antimicrobial material through a catheter entry orifice and about the indwelling catheter itself in the vicinity of the entry orifice. In a device which is directly associated with the method of Raad, the sleeve utilizes two parallel conductive elements which are operably connected to a power source and related electronics which energize the conductive elements to create and induce oligodynamic activity proximal to the indwelling catheter and which are disposed in the jacket. A weaving structure is disclosed whereby conductive, ion emitting wires are maintained in a substantially parallel orientation along longitudinal radial segments surrounding the captured catheter.
The second part of a two part device is a second subassembly which is releasibly affixed to the jacket part preferrably by a snap action. This action also, preferably, firmly affixes the jacket and therefore the sleeve to the indwelling catheter. The second part includes a self-contained battery power source and electronics associated with controlled elution of the antimicrobial substance. To transfer material disseminating power to conductive wires, complementary connections to connectors of the first part are conjoined when the second part is affixed to the first part. For use with devices related to Raad, the electronics provide a periodic, alternating and/or pulsed charge, using low current drain electronics for prolonging the life of the energizing battery.
Accordingly, it is a primary object to provide a device which may be affixed to unmodified catheters in the vicinity of a percutaneous or orifice entry site and which supplies antimicrobial substances at the site for the purpose of reducing infection attributed to catheter use.
It is a further object to provide a device which may be affixed to a long term indwelling catheter and provide effective antimicrobial activity for an extended period, which may be three months or longer.
It is an important object to provide an electrical circuit for eluting heavy metal ions in a predefined and controlled manner.
It is another object that the electrical circuit be provided in a self-contained package which is a part of the device.
It is still another object that the electrical circuit include a battery.
It is an object that heavy metal ions be eluted from more than one elongated
Dawson Glenn K.
Evans Paul S.
Iontophoretics Corporation
Maynard Jennifer
Thorne Gale H.
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