ANTIMICROBIAL INTRODUCER AND NEEDLE

A device for threading a conduit into a communication with a vein or artery beneath the skin of a patient, during insertion of components such as a PICC line is provided. Surfaces of a hollow needle, dilator, and sheath included in kit, and which are anticipated to contact the skin of a patient during the procedure are provided with an antimicrobial surface area formed thereon. The surface area so positioned prevents bacteria and other pathogens from occupying the contacting surfaces and thereby being communicated into the tissue below the patient's skin.

DETAILED DESCRIPTION OF THE PREFERRED

Embodiments of the Invention

Now referring to drawings inFIGS. 1-5, wherein similar components are identified by like reference numerals, there is seen inFIG. 1a view of an instrument for forming an initial pathway through a patient's skin layer, and underlying tissue, shown as an introducer12, of the present invention which includes the dilator14and the coaxially engageable sheath22. The various components of the device disclosed herein can be formed of metal or conventional plastic or polymeric materials adapted to the task such as a currently preferred material polytetrafluoroethylene (“PTFE”). However, it should be noted they can be formed of any material suitable for use in combination to form the disclosed surface area of anti-microbial material, for the elimination of pathogen and Infectious agents in the areas contacting or placed adjacent to flesh or skin of a patient, as noted in this disclosure.

A dilator14has a proximal end16shown with a locking nut17at a first end and terminating at a distal end18of a substantially tapered dilator body20component. The dilator body20body has an intermediate portion “I” extending from the proximal end16to a distal portion “d” of the dilator body20. The dilator14additionally includes an interior axial passage15of the elongated body20defined by an interior sidewall surface, axially communicating from the proximal end16, to the distal end18. The axial passage15allows the introducer12to be translated or advanced over a pre-positioned guidewire (not shown) as noted above.

Further, as can be seen the elongated dilator body20of the dilator14features an antimicrobial surface area21which may be positioned on the distal portion “d” which projects from the coaxial engagement with the sheath22shown inFIG. 2. Or, the antimicrobial surface area21may be positioned upon the exterior surface upon all surfaces which pierce or contact the skin layer, or are positioned immediately above the skin layer of the patient and which are likely to come in contact or be placed adjacent, with that skin layer during an insertion procedure.

Again, it must be noted that the dilator body20can alternatively be formed itself of a solid solution of polymeric or plastic material noted which is antimicrobial impregnated with the noted antimicrobial materials herein which when cured forms a solid solution with the polymeric or plastic material forming the sheath22and/or deluder body20, as a means for long term communication of antimicrobial agents thereto.

However, in other preferred modes the interior surface area of the axial passage15, as well as a portion or all of the exterior surface of the body20, may additionally be coated or otherwise provided a antimicrobial surface area21having anti-microbial properties thereon by either an impregnated coating or film, or other manner to position an antimicrobial surface area21on the interior surface and exterior surface. In addition, the proximal end16including locking nut17may also employ an antimicrobial surface area21as needed. The entire interior surface of the axial passage15should have the antimicrobial surface, and depending on the insertion depth of the body20, during an insertion procedure, sufficient surface area should be covered with antimicrobial surface area21such that any area contacting or adjacent to skin or tissue is covered.

It is to be noted that the antimicrobial surface area21for all surfaces, may be applied by any conventional means known in the art such as vacuum chamber coating, plasma coating, for metal and some plastics and/or employment of an antimicrobial material or agent with a polymeric material which hardens to form a solid solution of antimicrobial impregnated polymeric material in a surface layer, or a mixture of antimicrobial material with an other adhering carrier used to form the antimicrobial surface areas21as would be known in the art.

Such materials include one or a combination of antimicrobial materials in a mix with the material used for forming the component itself, or, mixed in a carrier such as a polymeric material such as polyurethane or polyurethane-acrylates, which forms an adhering surface which when applied, and upon curing, is impregnated in a solid solution with and communicates antimicrobial material, to an exterior surface. Such polymeric material should have excellent adhesion and temperature resistance past 250 degrees Fahrenheit, when cured to form a solid solution of the polymer and antimicrobial communicating material. This allows the device to be sterilized in an autoclave or other heat type sterilization process.

For instance silver nitrate which over time produces silver ions, is combined by weight from 15 to 25% of the total mixture weight, with a polymeric material such as polyurethane or polyurethane-acrylates, and upon curing to form a solid solution coating, on any surface area to be protected, produces an excellent antimicrobial surface area21forming a solid solution of silver ion producing silver or silver nitrate evenly distributed withing the formed polymeric material layer.

The formed surface area21thus continually communicates silver ions to the areas it is placed on an instrument surface area coming in contact with skin or tissue or placed adjacent thereto. Over a long time period, the communicated silver ions provide an antimicrobial agent to eliminate bacteria, viruses, and other infectious agents in the surface area21of formed or coated surface which is placed anywhere the instrument contacts skin or flesh and a distance above the piercing.

Or, the formed surface area21may also be formed with, or include, other anti microbial materials from a group including nitrofurazone-coated silicone or copper or copper bearing materials in a curing polymer coating, and/or chlorhexidine incorporated hydroxylapatite coatings, and/or chlorhexidine-containing polylactide coatings on an anodized surface, and/or polymer and calcium phosphate coatings mixed with chlorhexidine.

The sheath22is shown inFIG. 2in the coaxially engaged position with the dilator14and has a proximal end24shown as having the locking nut17and handle31thereon. Extending from the proximal end24is the elongated cylindrical sheath body28, which communicates to an open distal end26from which the distal portion “d” of the dilator body20projects when coaxially engaged.

The sheath22additionally includes an axial passageway25, defined by an interior passage wall surface of the cylindrical sheath body28communicating between openings at the proximal end24and the distal end26. The axial passageway25of the sheath is intended to receive the intermediate portion “I” of the dilator body20, therethrough in an engaged position, such that the distal portion “d” at the distal end18of the dilator body20, will protrude past the distal end26, of the sheath body22as shown inFIG. 2.

Further, it is preferred in the present invention to provide the above noted antimicrobial surface areas21, yielded by application of antimicrobial materials or formation of solid solutions of polymeric material and antimicrobial material forming the sheath body28and dilator body20, to form an antimicrobial surface area21, on all, or a sufficient area of the sheath body28, and distal portion “d” which contact skin and flesh and which may extend above the skin, during an insertion procedure, in order to reduce or essentially eliminate infectious agents such as viruses or bacteria on any contact with an insertion site during operative employment of the introducer12in an insertion procedure.

In addition, the proximal end24of the sheath and the locking nut17and handle31may also be formed of plastic or polymeric infused material or have the noted anti-microbial material coating or film covering them. Further, the interior passage wall forming the passageway25is preferably totally additionally be coated with, film covered with, or impregnated with, or imbedded with one or a combination of the anti-microbial materials herein, to form an antimicrobial surface area21along the entire surface forming the axial passageway2. As noted, the term “coated” is for convenience and is intended to include any coating, film, or surface adhered or impregnated with, the antimicrobial surface area21, such that in all areas contacting skin or flesh or adjacent thereto, antimicrobial particles or properties are communicated thereto to prevent or minimize infectious particles and pathogens.

At a minimum, one or more surface areas from a group of surface areas should be covered with an antimicrobial surface area21so that areas that come into contact with the skin, or with components which contact the skin, are protected. This group of surface areas would include, the interior surface of the axial conduit33, the exterior surface of the needle body36, the passage wall of the axial passageway25, the exterior surface of the sheath body28, the distal portion “d” of the dilator body20, and the interior sidewall of the axial passage15. Further included can be the intermediate portion “I” of the exterior of dilator body20and the handle31, since these areas may come into contact with skin or flesh, or can come into contact with components which come into contact with skin or flesh during an insertion procedure. Of course all of the dilator body20surfaces, the sheath28surfaces, and the needle surfaces may be covered in their entirety also for maximum protection.

In viewing the drawings, shown inFIG. 3, the seldinger needle30is shown as having needle body36with proximal end32, with a needle hub39and pointed distal end34of a needle body36. The needle body36may be formed of metal and preferably has an antimicrobial surface area21on all or most of the exterior surface of needle body38and the interior surface defining an axial conduit33running through the needle body36, which as noted may be provided by the polymeric or plastic or film or vapor deposit of material having antimicrobial material therein forming an anti-microbial surface area21on the exterior and interior surfaces of the elongated needle body38as noted herein or other means providing surfaces with anti-microbial properties. It would be preferable in most cases, if cost is not an issue, to cover the entire exterior of the needle body38and the interior surface of the axial conduit33running through the needle body38since they are likely to always contact with, or come into contact with components which contact the patient's skin or underlying flesh.

FIG. 4shows a mode of the device10with the needle30and introducer12engaged within sterile packaging40as is conventional in the art. The packaging40may have a tear-away corner42allowing the user to open the packaging40and retrieve the needle30and introducer12. However, it is noted that the needle30and introducer12in addition to having respective surface area may be sterilized and packaged separately.

FIG. 5shows yet another mode of the disclosed device providing the user with a means for adapting existing unprotected instruments such as introducer100and needle200with an antimicrobial coating. Currently, this is provided by a spray bottle44or other container for discharging a mixture of a curing carrier such as polyethylene or another polymeric material which will cure when exposed to air or with addition of a curing agent. The antimicrobial material46mixed to dispense with the polymeric or other curing carrier, in a spray, stream, atomized spray, or the like, for the purpose of user applying an area covered with a cured solid solution of polymeric material and antimicrobial agent such as silver nitrate which will communicate silver ions to the antimicrobial surface area21formed by the dispensed mixture46on the desired unprotected surfaces of instruments100,200. However it is noted that other modes are envisioned wherein the antimicrobial material is provided as a liquid, gas, salve, balm, or the like which allows the user to apply a coating onto the desired instrument.