BACKGROUND OF THE INVENTION

1. Field of the Invention

This Application Claims Priority to U.S. Provisional Patent Application Serial Number, 61/607512 filed on March 6, 2012, and included herein in its entirety by this reference thereto.

The present invention relates to an introducer and needle employed in providing intra vascular access to a patient. More specifically, the invention relates to an antimicrobial coated introducer and seldinger needle used in combination therewith, which, so coated, provides means for preventing the communication of surface area bacteria, into the insertion site.

Infection of the tissue at and adjacent to an insertion site, and/or the vascular system of a patient may easily occur when the skin of the patient is punctured during the insertion of a needle through the skin and into a vein or artery. Infectious agents such as bacteria, viruses, fungi, and other infectious agents disposed on and about the exterior surface of the skin of a patient, on conventional needles, may easily be drawn into the insertion site through a contact with the exterior surface of a needle and/or an introducer, with the skin, during the puncturing of the skin barrier. This invasion of infectious agents, can lead to inflamation and cell destruction in the tissues surrounding the puncture, or other remote infection sites should an infectious agent carried on the needle or introducer reach the patient's blood stream. The present invention provides a solution to the shortcomings of such needles and introducers through the provision of an infectious agent preventing antimicrobial coating, disposed the skin-contacting surfaces of and introducer and needle used in combination therewith, to thwart the communication of Infectious agents such as bacteria and viruses into the flex below an insertion site.

2. Prior Art

Intravascular catheters such as periphery inserted central catheters (PICC) are forms of intravenous access components which are often employed for chemotherapy regimes, antibiotic therapy, prenatal nutrition, and other treatments requiring vascular communication from outside the body of the patient. These types of catheters or conduits are often used for extended periods of time which can extend to 30 days or more. In use, the PICC, or other type catheter, must first be communicated into a vascular conduit or peripheral vein such as the cephalic vein, basilic vein, or brachial vein. Once the catheter providing the fluid conduit is inserted through the skin and into the patient's vascular system, it is advanced toward the heart to a positioning point. At this positioning point, generally, the needle tip is in a positioned communication with the cavoatrial junction.

Conventionally, insertion of the catheter through the skin and surrounding tissue of the vascular system is accomplished by a multi step process. This process is performed by a medical professional employing a plurality of medical components and instruments or tools. A commonly employed tool for piercing the skin and tissue of a patient is known as an introducer. The introducer is inserted through the skin and tissue and a distal end placed in communication with the target artery or vein of the vascular system of the patient. Once the introducer is properly engaged, it provides a conduit for the physician to easily insert the catheter axially therethrough, once the target vein has been located.

Briefly, the introducer includes a dilator including an elongated dilator body having a distal tapered region, and a tear-away sheath having an inner axial bore. The inner bore is configured to receive the dilator such that a portion of the tapered region of the dilator extends from the sheath distal end.

To properly insert and position the distal end of the catheter, for communicating and delivering the medication directly to the vascular system of the patient, first, a tourniquet or similar device is applied to the arm or leg of the patient at a position above the anticipated insertion site. This constricts blood flow thereby providing means to distend the veins so as to allow the medical professional to target a vein or artery of choice.

Subsequent to targeting the vein or artery, an introducer needle, often called a "seldinger" needle, engaged to a forward portion of a syringe, is inserted into the target vein and the tourniquet is released. The syringe is then removed and the user seals or places their thumb over the end of the needle to prevent blood loss or an intake of an air embolism.

Employing a flexible guidewire, the distal end of the guidewire is then inserted axially through the passage running through the seldinger needle until only the proximal portion of the guidewire is visible. The guidewire is advanced with a forward motion into and past the needle hub into the target vein. With the guidewire in place the needle is removed.

Next, the introducer, including sheath and dilator, is threaded over the proximal end of the guidewire and into communication with the target vein. Often a physician will nick the skin with a safety scalpel for easier advancement of the dilator. Once a proper catheter length for the determined extension into the patient has been determined, the dilator is removed from the sheath.

In a subsequent step, the distal tip of the catheter is inserted into and through the sheath until the catheter tip is correctly positioned within the target vein. The tear-away sheath is then removed by pulling it out of the vessel while simultaneously splitting the sheath. From here, adjustments can be made to the positioning of the distal end of the catheter.

As one can clearly see, there are numerous deliberate and precise actions which take place at an insertion site in such a procedure so to successfully position the catheter. Such being, namely, the insertion and removal of the needle through the protective skin layer and underlying tissue, followed by insertion and removal of the introducer through the same pathway. Although modern medicine provides means to sterilize these components and they are provided in sterile packages, there is a great chance of picking up and driving surface area pathogens and infectious agents such as bacteria and viruses, past the skin and into the flesh and vein below the insertion site. The exterior surface of the distal end of the introducer extending forward of the surrounding sheath, provides a surface carrier for such infectious agents as it passes through the skin barrier an underlying tissue and communicates through the vessel wall and into the intended blood vessel.

Such contamination can lead to the introduction of pathogens or infectious agents including one or a combination of such from a group including at least viruses, bacteria, fungi, or even parasites. This introduction transports the infectious agents past the skin barrier which had been preventing entry, and into the underlying tissue and or vein or artery of the body of the patient. For example, common bacterial skin pathogens include staphylococcus aureus and hemolytic streptococci, both of which can easily live on the skin of patients, and in the air and on various surfaces at hospitals. Herpes simplex is another common pathogen which is a viral skin disease and easily communicated into the body of the patient during such a piercing.

While attempts, modernly, have been made to increase sterilization using heat, light, and steam, and the like, there continues to be an increase in the communication of pathogens or infectious agents which thrive on the skin of patients or may be acquired on the skin of patients, into the tissues and vascular systems of patients undergoing such catheter insertion procedures.

As such, there is a continuing unmet need for a needle and introducer, configured for use in a method which provides enhanced protection against the communication of pathogens and infectious agents into the body of the patient. Such a device enabling such enhanced preventions should provide additional means beyond conventional sterilization techniques, to prevent such infectious agents from entering the underlying tissue and vascular system of a patient through an insertion site when medical devices are communicated through the skin of a patient. Such a device should provide anti pathogenic or antimicrobial surface property to exterior surfaces of the introducer and needle employed in combination therewith, to thereby extinguish or inhibit the growth of pathogens communicating the infectious agents to underlying tissue upon a contact with the respective exterior surfaces.

The forgoing examples of related art and any limitation related therewith are intended to be illustrative and not exclusive, and they do not imply any limitations on the invention described and claimed herein. Various limitations of the related art will become apparent to those skilled in the art upon a reading and understanding of the specification below and the accompanying drawings.

SUMMARY OF THE INVENTION

The device herein disclosed and described provides a component employable in a method as a solution to the shortcomings in prior art of preventing the incursion of pathogens and infections agents through injection sites on patients. The device herein disclosed achieves the above noted goals through the provision of medical instruments employing antimicrobial surface areas having properties providing means for prevention or inhibiting the growth and/or positioning of such infectious agents on the exterior surfaces of the device.

In at least one preferred mode of the disclosed device, there is provided an

antimicrobial surface area covering the exterior of medical instruments which are employed to form a communication through the skin of a patient for communication of a conduit such as a catheter to an intended blood vessel or other target area. The formed antimicrobial properties of the device are provided by an antimicrobial surface layer or coating which kills or inhibits the growth of infectious agents and/or pathogens thereon which may be communicated thereto from the patient's skin or air in the venue where it is used. The coating or material positioned on the instrument is positioned to cover a distance sufficient to communicate the instrument through the skin, in contact therewith, position such covering above the exterior surface of the patient's skin during the insertion procedure. This coating or material positioning is formed upon the skin-contacting surfaces of an introducer such as a tear-away/peel-away introducer and a seldinger needle.

In a first preferred mode the needle and introducer of the present invention are preferably coated from a distal end for a distance calculated to extend through the skin incision and a distance above the skin layer, with an antimicrobial area of a coating or layer on either or both the outer surface and inner surface areas. In this fashion, during any communication of the instrument through the skin, and into the patient, pathogens such as bacteria, viruses, and other infectious agents occupying the exterior and any underlying layers of skin, will come into direct contact only with the surface area bearing the antimicrobial coating.

In this mode, the device may be further sterilized using conventional heat, steam, chemical or light sterilization techniques and be subsequently sealed in sterilized packages as is commonly known in the art. For use, the devices are removed from the packages, to be provided to the user, in a conventional manner.

However, other modes are envisioned wherein an antimicrobial section or surface area of the components is provided by a means for adapting existing and stocked pre- packaged and sterilized needle and introducer with the surface area of antimicrobial coating. For example, an antimicrobial coating material in the form of a liquid or vapor deposit gas may be provided which allows the user to apply the material directly to existing needle and introducer devices prior to an insertion procedure into a patient. The antimicrobial material can be provided in a spray bottle for atomizing the antimicrobial material, a salve, balm, or the like allowing a user to apply an antimicrobial coating for adapting an existing needle and introducer the advantages of such a coating. This mode of the invention provides additional utility in the art as it allows users to maintain their existing stock of sterilized needles and introducers and allows them to apply an antimicrobial coating prior to use on a patient.

In other preferred modes, the antimicrobial area of the needle and introducer is provided by the needle and introducer having surface areas which are impregnated or otherwise formed with antimicrobial materials and properties. Further, it must be noted that the antimicrobial material can be any material suitable for the intended purpose and having antimicrobial properties may be employed. Particularly favored, however, after experimentation, are one or a combination of materials in a coating or surface area extending from the distal end of the instrument which is first introduced through the skin, to a length positioning the coated surface above the skin layer once fully inserted during an insertion procedure.

Such materials can be one or a combination of antimicrobial materials, from a group of antimicrobial materials including nitrofurazone-coated silicone, silver or silver ions or silver nano-particles in a solid solution formed in combination with an adhering polymeric coating, copper or copper bearing materials in a solid solution formed in combination with an adhering polymeric coating, chlorhexidine incorporated hydroxylapatite coatings, or chlorhexidine-containing polylactide coatings. Also included in the group of antimicrobial materials can be an anodized surface having polymer and calcium phosphate coatings with chlorhexidine, viral inhibitors, fungal inhibitors, as well as known bactericides.

With respect to the above description, before explaining at least one preferred embodiment of the herein disclosed invention in detail, it is to be understood that the invention is not limited in its application to the details of construction and to the arrangement of the components in the following description or illustrated in the drawings. The invention herein described is capable of other embodiments and of being practiced and carried out in various ways which will be obvious to those skilled in the art. Also, it is to be understood that the phraseology and terminology employed herein are for the purpose of description and should not be regarded as limiting.

As such, those skilled in the art will appreciate that the conception upon which this disclosure is based may readily be utilized as a basis for designing of other structures, methods and systems for forming an instrument to communicate through the patient's skin to an interior position and project from an incision in the skin, and for carrying out the several purposes of the present disclosed device. It is important, therefore, that the claims be regarded as including such equivalent construction and methodology insofar as they do not depart from the spirit and scope of the present invention.

As used in the claims to describe the various inventive aspects and embodiments, "comprising" means including, but not limited to, whatever follows the word "comprising". Thus, use of the term "comprising" indicates that the listed elements are required or mandatory, but that other elements are optional and may or may not be present. By "consisting of is meant including, and limited to, whatever follows the phrase "consisting of. Thus, the phrase "consisting of indicates that the listed elements are required or mandatory, and that no other elements may be present. By "consisting essentially of is meant including any elements listed after the phrase, and limited to other elements that do not interfere with or contribute to the activity or action specified in the disclosure for the listed elements. Thus, the phrase "consisting essentially of indicates that the listed elements are required or mandatory, but that other elements are optional and may or may not be present depending upon whether or not they affect the activity or action of the listed elements.

It is an object of the invention to provide an instrument for communication of a pathway through the skin layer and underlying tissue of a patient, to an interior target, employing antimicrobial properties in a contact layer which has an antimicrobial coating on one or both of an exterior surface and interior surface, such as seldinger needles and introducers employed in implanting intra-vascular catheters.

It is another object of the invention to provide a means for adapting existing instruments with a user applied antimicrobial coating.

These and other objects features, and advantages of the present invention, as well as the advantages thereof over existing prior art, which will become apparent from the description to follow, are accomplished by the improvements described in this specification and hereinafter described in the following detailed description which fully discloses the invention, but should not be considered as placing limitations thereon.

BRIEF DESCRIPTION OF DRAWING FIGURES

Figure 1 shows a view of the introducer of the present invention depicting the dilator and sheath components in an exploded view showing the intermediate portion of the introducer body which is covered by the sheath when engaged, and projecting distal portion thereof, employing a antimicrobial coating.

Figure 2 is a view of the introducer in the as used assembled mode with the dilator coaxially engaged with the sheath and the distal portion of the introducer body projecting therefrom.

Figure 3 shows a view of a seldinger needle employing a anti-microbial coating on the axial passage and exterior surface of the needle body.

Figure 4 shows a mode of the device with the introducer and needle engaged in sterile packaging.

Figure 5 shows a view of another mode of the device providing a spray bottle or other suitable means allowing the user to adapt existing instruments with an applied antimicrobial coating in an evaporative adhesive carrier.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS OF THE INVENTION

Now referring to drawings in figures 1-5, wherein similar components are identified by like reference numerals, there is seen in FIG 1 a view of an instrument for forming an initial pathway through a patient's skin layer, and underlying tissue, shown as an introducer 12, of the present invention which includes the dilator 14 and the coaxially engageable sheath 22. 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 antimicrobial 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 dilator 14 has a proximal end 16 shown with a locking nut 17 at a first end and terminating at a distal end 18 of a substantially tapered dilator body 20 component. The dilator body 20 body has an intermediate portion "I" extending from the proximal end 16 to a distal portion "d" of the dilator body 20. The dilator 14 additionally includes an interior axial passage 15 of the elongated body 20 defined by an interior sidewall surface, axially communicating from the proximal end 16, to the distal end 18. The axial passage 15 allows the introducer 12 to be translated or advanced over a pre-positioned guidewire (not shown) as noted above.

Further, as can be seen the elongated dilator body 20 of the dilator 14 features an antimicrobial surface area 21 which may be positioned on the distal portion "d" which projects from the coaxial engagement with the sheath 22 shown in figure 2. Or, the antimicrobial surface area 21 may 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 body 20 can 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 sheath 22 and/or deluder body 20, as a means for long term communication of antimicrobial agents thereto.

However, in other preferred modes the interior surface area of the axial passage 15, as well as a portion or all of the exterior surface of the body 20, may additionally be coated or otherwise provided a antimicrobial surface area 21 having anti-microbial properties thereon by either an impregnated coating or film, or other manner to position an antimicrobial surface area 21 on the interior surface and exterior surface. In addition, the proximal end 16 including locking nut 17 may also employ an antimicrobial surface area 21 as needed. The entire interior surface of the axial passage 15 should have the antimicrobial surface, and depending on the insertion depth of the body 20, during an insertion procedure, sufficient surface area should be covered with antimicrobial surface area 21 such that any area contacting or adjacent to skin or tissue is covered.

It is to be noted that the antimicrobial surface area 21 for 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 areas 21 as 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 area 21 forming a solid solution of silver ion producing silver or silver nitrate evenly distributed withing the formed polymeric material layer.

The formed surface area 21 thus 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 area 21 of formed or coated surface which is placed anywhere the instrument contacts skin or flesh and a distance above the piercing.

Or, the formed surface area 21 may 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 sheath 22 is shown in figure 2 in the coaxially engaged position with the dilator 14 and has a proximal end 24 shown as having the locking nut 17 and handle 31 thereon. Extending from the proximal end 24 is the elongated cylindrical sheath body 28, which communicates to an open distal end 26 from which the distal portion "d" of the dilator body 20 projects when coaxially engaged.

The sheath 22 additionally includes an axial passageway 25, defined by an interior passage wall surface of the cylindrical sheath body 28 communicating between openings at the proximal end 24 and the distal end 26. The axial passageway 25 of the sheath is intended to receive the intermediate portion "I" of the dilator body 20, therethrough in an engaged position, such that the distal portion "d" at the distal end 18 of the dilator body 20, will protrude past the distal end 26, of the sheath body 22 as shown in FIG 2.

Further, it is preferred in the present invention to provide the above noted

antimicrobial surface areas 21 , yielded by application of antimicrobial materials or formation of solid solutions of polymeric material and antimicrobial material forming the sheath body 28 and dilator body 20, to form an antimicrobial surface area 21, on all, or a sufficient area of the sheath body 28, 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 introducer 12 in an insertion procedure.

In addition, the proximal end 24 of the sheath and the locking nut 17 and handle 31 may 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 passageway 25 is 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 area 21 along the entire surface forming the axial passageway 2. 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 area 21, 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 area 21 so 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 conduit 33, the exterior surface of the needle body 36, the passage wall of the axial passageway 25, the exterior surface of the sheath body 28, the distal portion "d" of the dilator body 20, and the interior sidewall of the axial passage 15.

Further included can be the intermediate portion "I" of the exterior of dilator body 20 and the handle 31 , 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 body 20 surfaces, the sheath 28 surfaces, and the needle surfaces may be covered in their entirety also for maximum protection.

In viewing the drawings, shown in FIG 3, the seldinger needle 30 is shown as having needle body 36 with proximal end 32, with a needle hub 39 and pointed distal end 34 of a needle body 36. The needle body 36 may be formed of metal and preferably has an antimicrobial surface area 21 on all or most of the exterior surface of needle body 38 and the interior surface defining an axial conduit 33 running through the needle body 36, 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 area 21 on the exterior and interior surfaces of the elongated needle body 38 as 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 body 38 and the interior surface of the axial conduit 33 running through the needle body 38 since they are likely to always contact with, or come into contact with components which contact the patient's skin or underlying flesh.

FIG 4 shows a mode of the device 10 with the needle 30 and introducer 12 engaged within sterile packaging 40 as is conventional in the art. The packaging 40 may have a tear- away corner 42 allowing the user to open the packaging 40 and retrieve the needle 30 and introducer 12. However, it is noted that the needle 30 and introducer 12 in addition to having respective surface area may be sterilized and packaged separately.

FIG 5 shows yet another mode of the disclosed device providing the user with a means for adapting existing unprotected instruments such as introducer 100 and needle 200 with an antimicrobial coating. Currently, this is provided by a spray bottle 44 or 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 material 46 mixed 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 area 21 formed by the dispensed mixture 46 on the desired unprotected surfaces of instruments 100, 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.

While all of the fundamental characteristics and features of the invention have been shown and described herein, with reference to particular embodiments thereof, a latitude of modification, various changes and substitutions are intended in the foregoing disclosure and it will be apparent that in some instances, some features of the invention may be employed without a corresponding use of other features without departing from the scope of the invention as set forth. It should also be understood that various substitutions, modifications, and variations may be made by those skilled in the art without departing from the spirit or scope of the invention. Consequently, all such modifications and variations and substitutions are included within the scope of the invention as defined by the following claims.